ATHEROGENICS, INC.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended December 31, 2007
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number 0-31261
AtheroGenics, Inc.
(Exact name of Registrant as specified in its charter)
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Georgia
(State or other jurisdiction of
incorporation or organization)
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58-2108232
(I.R.S. Employer Identification Number) |
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8995 Westside Parkway,
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(678) 336-2500 |
Alpharetta, Georgia 30004
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(Registrants telephone number, including area code) |
(Address of principal executive offices, including zip code) |
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Securities registered pursuant to Section 12(b) of the Act:
Common Stock, No Par Value
Common Stock Purchase Rights
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K
or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company.
See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
The aggregate market value of shares of voting stock held by nonaffiliates of the registrant,
computed by reference to the closing price of $2.14 as reported on the Nasdaq Global Market as of
the last business day of AtheroGenics most recently completed second fiscal quarter (June 29,
2007), was approximately $61,838,168. AtheroGenics has no nonvoting common equity.
The number of shares outstanding of the registrants common stock, as of February 25, 2008:
39,518,492.
Documents Incorporated by Reference:
Portions of the proxy statement filed pursuant to Regulation 14A under the Securities Exchange
Act of 1934 with respect to the 2008 Annual Meeting of Shareholders are incorporated herein by
reference in Part II, Item 5 and Part III.
ATHEROGENICS, INC
FORM 10-K
INDEX
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PART I
Item 1. Business
Overview
AtheroGenics is a research-based pharmaceutical company focused on the discovery, development
and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including
diabetes and coronary heart disease. We currently have one late stage clinical drug development
program.
AGI-1067 is our investigational oral drug with demonstrated anti-inflammatory and antioxidant
properties that is being studied to determine its ability to improve glycemic control (blood sugar
levels) in patients with diabetes and potentially reduce clinical events in patients with
coronary heart disease. Diabetes is a chronic, metabolic disease in which the body does not
produce enough and/or respond to, insulin. Insulin is a key hormone that is needed to allow sugar
and other nutrients to be utilized as sources of energy for all body functions. Oxidative stress
and inflammation are believed to play a key role in reducing the bodys ability to respond to
insulin effectively, a condition referred to as insulin resistance. Development of serious
complications, including heart attack, stroke and death have been directly linked to increased
insulin resistance as a result of excessive inflammation and oxidative stress. These factors
appear to contribute to these serious cardiovascular problems not only in people with type 2
diabetes but in the much larger population of people who have insulin resistance but are not
diabetic.
In 2003, we initiated a Phase III
clinical trial, referred to as ARISE (Aggressive Reduction of
Inflammation Stops Events), which was conducted in cardiac centers in the United States, Canada,
the United Kingdom and South Africa. More than 6,100 patients enrolled in the study. ARISE
evaluated the impact of AGI-1067 on a composite measure of heart disease outcomes, including death
due to coronary disease, myocardial infarction (heart attack), stroke, coronary re-vascularization
and unstable angina. Important measures of glycemic control were pre-specified for patients with
diabetes who also had coronary heart disease. The study assessed the incremental benefits of
AGI-1067 versus the current standard of care therapies in this patient population. As such, all
patients in the trial, including those on placebo, received other appropriate heart disease and
diabetes medications, including statins and other cholesterol-lowering therapies, and glycemic
control agents.
The ARISE trial results were reported in March 2007 and demonstrated that while AGI-1067 did
not show a difference from placebo in the composite primary endpoint, the study did achieve a
number of other important predefined endpoints. These endpoints included a reduction in the
composite of hard atherosclerotic clinical endpoints, composed of cardiovascular death,
resuscitated cardiac arrest, myocardial infarction and stroke. AGI-1067 achieved a significant
reduction of 19% in the rate of these combined hard endpoints. A subgroup analysis indicated that
this result was consistent across important sub-populations such as patients with and without
diabetes, and men and women. There were also improvements in the key diabetes parameters of
new-onset diabetes and glycemic control. Patients without diabetes in the AGI-1067 treatment group
were 63% less likely to develop new-onset diabetes than patients on placebo. In patients with
diabetes, AGI-1067 improved glycemic control as measured by a statistically significant reduction
in an important measure of glycemic control, called HbA1c. Compared to placebo, AGI-1067 was
associated with a drop in HbA1c by 0.5% units at 12 months. This is considered a clinically
meaningful improvement. The ARISE patients had a mean baseline HbA1c of 7.2% which is close to
normal. Our analysis of the safety data indicated that the most common adverse event was transient
diarrhea; however, this effect only infrequently resulted in patient discontinuation. There was
also an observed increase in abnormal liver function tests in a small number of patients compared
to those on standard of care and one case of liver failure in the treatment group. All incidents of
liver dysfunction reversed when treatment was discontinued. Based on our review of the ARISE
results, we are pursuing continued development of the compound, initially as a diabetes medication.
We expect that two positive registration studies in patients with diabetes will be required to
submit a New Drug Application (NDA) for marketing approval.
In August 2007, we commenced the first registration study for diabetes called ANDES (AGI-1067
as Novel Anti-Diabetic Agent Evaluation Study), a multi-center, double-blind study with 6-month
dosing using three doses, designed to compare the effects of AGI-1067 versus placebo on glycemic
endpoints in subjects with confirmed type 2 diabetes. The trial was designed
to confirm the positive diabetes findings from the ARISE Phase III clinical trial. In November
2007, after discussions with the Food and Drug Administration (FDA), we discontinued the 300 mg
dose of AGI-1067 in ANDES based on a further review of the overall risk/benefit profile observed in
the ARISE clinical trial. The ANDES trial will continue with the two other doses being studied, 75
mg and 150 mg. Patient enrollment for ANDES was completed in December 2007. Dosing is expected to
be completed in June 2008. The study protocol provides for an interim analysis which we expect to
occur in the second quarter of 2008. Further development activity, including design of the second
registration study, will be determined after reviewing the results of ANDES and conducting
discussions with the FDA.
1
In 2005, we entered into a license and collaboration agreement with AstraZeneca for the global
development and commercialization of AGI-1067. Under the terms of the agreement, we received a
license fee of $50 million. In April 2007, AstraZeneca notified us that pursuant to the terms of
the agreement, it was ending the collaboration. The agreement was terminated in July 2007.
In the second half of 2006, we were engaged by AstraZeneca to conduct FOCUS (Follow-up Of
Clinical Outcomes: The Long-term AGI-1067 plus Usual Care Study). FOCUS is a follow-up Phase III
clinical trial for patients exiting ARISE, designed to collect extended safety information.
Pursuant to the terms of our license agreement, AstraZeneca funded the entire cost of the trial,
which has been concluded.
AGI-1096, our second v-protectant® candidate, is a novel antioxidant and selective
anti-inflammatory agent to address the accelerated inflammation of grafted blood vessels, known as
transplant arteritis, common in chronic organ transplant rejection. We have been working with
Astellas Pharma Inc. (Astellas) to further develop AGI-1096, with Astellas funding the costs for
development activities under the agreement. Astellas has an exclusive option to negotiate with us
for late stage development and commercial rights to AGI-1096. In a Phase I clinical trial
investigating the safety and tolerability of oral AGI-1096 in combination with Astellas tacrolimus
(Prograf®) conducted in healthy volunteers, results indicated that regimens of AGI-1096
administered alone, and concomitant with tacrolimus, were generally well-tolerated, and there were
no serious adverse events associated with either regimen during the study. Astellas has informed
us that they have completed their current development activities and do not have further
development plans. We are not currently undertaking any development activities on AGI-1096.
Business Strategy
Our long-term goal is to build a leading pharmaceutical company through the successful
discovery, development and commercialization of novel drugs for the treatment of chronic
inflammatory diseases. Key elements of our overall long-term strategy are to:
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Continue advancing the development program for AGI-1067.
We intend to develop AGI-1067 for the treatment of patients with type 2 diabetes and
coronary heart disease with the goal of filing an NDA with the FDA. |
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Expand our clinical product portfolio. We intend to acquire rights to other product
candidates and technologies that complement our existing product candidate line or that
enable us to capitalize on our scientific and clinical development expertise. We plan to
expand our product candidate portfolio by in-licensing or acquiring product candidates,
technologies or companies to help maximize the commercial opportunity and mitigate the risks
inherent in drug discovery and development. Our long-term strategy also includes developing
product candidates discovered by company scientists. |
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Commercialize our products. We plan to collaborate with large pharmaceutical companies
to draw on their commercialization expertise in broad therapeutic categories and to maximize
the commercial potential of our product candidates. We also intend to develop an independent
sales force to help insure broader distribution of our products or to independently sell our
products that target narrow therapeutic markets and to build a sustainable business to
support our evolution into a commercial entity. |
In May 2007, we implemented an organizational restructuring plan that reduced our workforce by
approximately 50% to 67 employees. This action, based on results from our ARISE clinical trial,
was designed to streamline company operations and continue advancing the development of AGI-1067.
As a result, our near-term strategy is to focus specifically on developing AGI-1067 for diabetes.
As of February 25, 2008, we had approximately $30.5 million of convertible notes outstanding
that will become due on September 1, 2008. We expect to have enough cash on hand to repay all
amounts due pursuant to these notes. In order to fund ongoing operations during 2009 we intend to
either raise additional capital before or after the maturity date of the notes, enter into
collaboration arrangements to fund the development and commercialization of AGI-1067 or attempt to
restructure the notes before they become due.
2
Inflammation, Oxidative Stress and Disease
Inflammation is a normal response of the body to protect tissues from infection, injury or
disease. The inflammatory response begins with the production and release of chemical agents by
cells in the infected, injured or diseased tissue. These agents cause redness, swelling, pain,
heat and loss of function. Inflamed tissues generate additional signals that recruit white blood
cells to the site of inflammation. White blood cells destroy any infective or injurious agent, and
remove cellular debris from damaged tissue. This inflammatory response usually promotes healing
but, if uncontrolled, may become harmful.
Oxidative stress and inflammation are normal processes that occur in the healthy body. When
exposed to a stimulus, the inflammatory response can be either acute or chronic. Acute
inflammation lasts at most only a few days. The treatment of acute inflammation, where therapy
includes the administration of aspirin and other non-steroidal anti-inflammatory agents, provides
relief of pain and fever for patients. In contrast, chronic inflammation lasts weeks, months or
even indefinitely, stimulating a response of increased oxidative stress, which may further
stimulate more inflammation, and causes tissue damage. In a chronic inflammatory and oxidative
stress state, the inflammation becomes the problem rather than the solution to infection, injury or
disease. Chronically inflamed tissues continue to generate inflammatory signals that attract white
blood cells from the bloodstream. When white blood cells migrate from the bloodstream into the
tissue they amplify the inflammatory response. This chronic inflammatory response can break down
healthy tissue in a misdirected attempt at repair and healing. Diseases characterized by chronic
inflammation include, among others, type 2 diabetes and
atherosclerosis, including coronary heart
disease.
Type 2 Diabetes
Diabetes is a chronic disease of metabolism, which is the way our bodies use digested food for
growth and energy. Most of the food we eat is broken down into glucose, the form of sugar in the
blood. Glucose is the main source of fuel for the body. After digestion, glucose passes into the
bloodstream, where it is used by cells for growth and energy. For glucose to get into cells,
insulin must be present. Insulin is a hormone produced by the pancreas, a large gland behind the
stomach. When we eat, the pancreas automatically produces the right amount of insulin to move
glucose from blood into our cells.
In people with type 2 diabetes, the cells do not respond appropriately to the insulin that is
produced (called insulin resistance), glucose levels build up in the blood, and the beta cells in
the pancreas which are responsible for producing the insulin ultimately fail. Insulin resistance
has been associated with coronary artery disease and subsequent cardiovascular events. It is
believed that oxidative stress and inflammation play a key role in the development of insulin
resistance and damage to the pancreas. Oxidation and inflammation have also been implicated in the
development and progression of cardiovascular disease.
Diabetes affects nearly 21 million people in the United States and is widely recognized as one
of the leading causes of death and disability. Type 2 diabetes is the most prevalent form of the
disease, accounting for about 90% of all diabetes cases in America. It is currently the fifth
leading cause of death by disease. About 65% of deaths among those with diabetes are attributed to
heart disease and stroke, and diabetes increases the risk of death from coronary heart disease by
two- to four-fold. Type 2 diabetes is associated with long-term complications, including damage to
the small blood vessels, called microvascular disease, in the eye (retinopathy), kidney
(nephropathy) and nervous system (neuropathy) and damage to larger blood vessels, called
macrovascular disease, leading to myocardial infarction, peripheral vascular
disease, and stroke.
Atherosclerosis
Atherosclerosis is a common cardiovascular disease that results from a complex inflammatory
process in arterial blood vessel walls, and depending on the location of the artery it affects, may
result in a heart attack or stroke. This process is accelerated with diabetes.
Atherosclerosis of the blood vessels of the heart is called coronary artery disease or heart
disease. It is the leading cause of death in the United States, claiming more lives each year than
all forms of cancer combined. Recent estimates suggest that nearly 16 million Americans are
diagnosed with some form of atherosclerosis. When atherosclerosis becomes severe enough to cause
complications, physicians must treat those complications, which include angina (chest pain), heart
attack, abnormal heart rhythms, heart failure, kidney failure, stroke, or obstructed peripheral
arteries. Many of the patients with established atherosclerosis are treated aggressively for their
associated risk factors, as with statins (cholesterol-lowering drugs), which have been repeatedly
shown to slow the progression of atherosclerosis and prevent future adverse events such as heart
attack, stroke and death. Other risk factors associated with atherosclerosis include diabetes,
high blood pressure, smoking, obesity and physical inactivity. Many atherosclerosis patients also
experience symptoms of angina and/or a history of acute coronary syndromes, such as myocardial
infarctions and unstable
3
angina. In addition, most of these patients have high cholesterol, and as
a result, current treatment focuses primarily on cholesterol reduction. These patients are also
routinely treated with anti-hypertensives to help lower high blood pressure and anti-platelet drugs
to help prevent the formation of blood clots. There are currently no medications available for
physicians to treat directly the underlying chronic inflammation of atherosclerosis.
Many physicians are only now becoming aware of the key role of chronic inflammation in such
diverse diseases as atherosclerosis and diabetes, and for which existing treatment strategies are
incomplete and underutilized. As more physicians recognize that a wide range of chronic diseases
are inflammatory in nature, we believe that these physicians will require safer and more effective
anti-inflammatory treatments.
V-Protectant® Technology
Our clinical compound, AGI-1067, is based on proprietary v-protectant® technology
targeted to the treatment of chronic inflammatory diseases. This platform is based on the work of
our scientific co-founders R. Wayne Alexander, M.D., Ph.D. and Russell M. Medford, M.D., Ph.D. In
1993, Drs. Alexander and Medford discovered a novel mechanism within arterial blood vessel walls
that could control the excessive accumulation of white blood cells without compromising the bodys
ability to fight infection. V-protectant® technology exploits the observation that the
endothelial cells that line the interior wall of the blood vessel play an active role in recruiting
white blood cells from the blood to the site of chronic inflammation. V-protectants®
are intended to block harmful effects of oxygen and other similar molecules, collectively called
oxidants. Scientists have known for some time that some oxidants can damage cells, but have more
recently determined that these same oxidants may also act as signals to modify gene activity inside
cells. This change in gene activity leads to the production of proteins that initiate or maintain
inflammation. The protein products of these cells, including an adhesion molecule, called VCAM-1,
attract white blood cells to the site of chronic inflammation. We believe that an excess number of
VCAM-1 molecules on the surface of cells is a disease state. We also believe that AGI-1067 acts as
an antioxidant by blocking the specific type of inflammation caused by oxidants acting as signals.
We believe that v-protectants® will provide this anti-inflammatory benefit without
undermining the bodys ability to protect itself against infection.
Products
The table below summarizes our therapeutic programs, their target indication or disease and
their development status.
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V-Protectant® Therapeutic Program |
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Disease/Indication |
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Development Status |
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AGI-1067
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Type 2 diabetes
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Phase III clinical trial |
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AGI-1067
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Atherosclerosis
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Phase III clinical trial completed |
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AGI-1096
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Transplant rejection
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Phase I clinical trial completed |
AGI-1067
AGI-1067 is our v-protectant® candidate that is most advanced in clinical
development. AGI-1067 is an investigational drug with demonstrated anti-inflammatory and
antioxidant properties that is being investigated to determine its ability to improve blood sugar
control in patients with diabetes and to potentially reduce clinical events in patients with
coronary heart disease. Diabetes is a chronic, metabolic disease in which the body does not
produce enough and/or respond to insulin. Insulin is a key hormone that is needed to allow sugar
and other nutrients to be utilized as sources of energy needed for all body functions. Oxidative
stress and inflammation are believed to play a key role in reducing the bodys ability to respond
to insulin effectively, a condition referred to as insulin resistance. Development of serious
complications, including heart attack, stroke and death have been directly linked to increased
insulin resistance as a result of excessive inflammation and oxidative stress. These factors
appear to contribute to these serious cardiovascular problems not only in people with type 2
diabetes but in the much larger population of people who have insulin resistance but are not
diabetic.
In 2003, we initiated a Phase III clinical trial, referred to as ARISE, which was conducted in
cardiac centers in the United States, Canada, the United Kingdom and South Africa. ARISE evaluated
the impact of AGI-1067 on a composite measure of heart disease
4
outcomes, including death due to
coronary disease, myocardial infarction, stroke, coronary re-vascularization and
unstable angina, and on diabetes in patients who have coronary heart disease. The study assessed
the incremental benefits of AGI-1067 versus the current standard of care therapies in this patient
population. As such, all patients in the trial, including those on placebo, received other
appropriate heart disease and diabetes medications, including statins and other
cholesterol-lowering therapies, and glycemic control agents. We completed patient enrollment with
more than 6,100 patients in the study.
In March 2007, findings from the ARISE study were presented. These data demonstrated that
treatment with AGI-1067 did not show a difference from placebo in the composite primary endpoint.
The study did achieve a number of other important predefined endpoints, including a reduction in
the composite of hard atherosclerotic clinical endpoints, composed of cardiovascular death,
resuscitated cardiac arrest, myocardial infarction and stroke. AGI-1067 achieved a significant
reduction of 19% in the rate of these hard endpoints. A subgroup analysis indicated that this result was consistent across
important sub-populations such as patients with and without diabetes, and men and women. There
were also improvements in the key diabetes parameters of new-onset diabetes and glycemic control.
Patients without diabetes in the AGI-1067 treatment group were 63% less likely to develop new-onset
diabetes. In patients with diabetes, AGI-1067 improved glycemic control as measured by a
statistically significant reduction in an important measure of glycemic control called HbA1c.
Compared to placebo, AGI-1067 was associated with a drop in HbA1c by 0.5% units at 12 months. This
is considered a clinically meaningful improvement. These patients had a mean baseline HbA1c of
7.2%, which is close to normal. Our analysis of the safety data indicated that the most common
adverse event was transient diarrhea; however, this effect only infrequently resulted in patient
discontinuation. There was also an observed increase in abnormal liver function tests in a small
number of patients compared to those on standard of care and one case of liver failure in the
treatment group. All incidents of liver dysfunction reversed when treatment was discontinued.
Based on our review of the ARISE results, we are pursuing continued development of the compound,
initially as a diabetes medication. We expect that two positive registration studies in patients
with diabetes will be required to submit an NDA for marketing approval.
In August 2007, we commenced the first registration study for diabetes called ANDES , a
multi-center, double-blind study with 6-month dosing using three doses, designed to compare the
effects of AGI-1067 versus placebo on glycemic endpoints in subjects with confirmed type 2
diabetes. The trial was designed to confirm the pre-specified diabetes findings from the ARISE
Phase III clinical trial. In November 2007, after discussions with the FDA, we discontinued use of
the 300 mg dose of AGI-1067 in ANDES, based on a further review of the overall risk/benefit profile
observed in the ARISE clinical trial. The ANDES trial will continue with the two other doses being
studied, 75 mg and 150 mg. Patient enrollment enrollment for ANDES was completed in December 2007.
Dosing is expected to be completed in June 2008. The study protocol provides for an interim
analysis which we expect to occur in the second quarter of 2008. We believe that ANDES will serve
as one of the registration studies needed for an NDA submission, and that at least one additional
trial will be required.
In 2007, we completed the FOCUS trial. FOCUS was a follow-up Phase III clinical trial for
patients exiting ARISE, designed to collect extended safety information.
AGI-1096
AGI-1096, our second v-protectant® candidate, is a novel antioxidant and selective
anti-inflammatory agent to address the accelerated inflammation of grafted blood vessels, known as
transplant arteritis, common in chronic organ transplant rejection. In a Phase I clinical trial
investigating the safety and tolerability of oral AGI-1096 in combination with Astellas tacrolimus
(Prograf®) conducted in healthy volunteers, results indicated that regimens of AGI-1096
administered alone, and concomitant with tacrolimus, were generally well-tolerated, and there were
no serious adverse events associated with either regimen during the study. Our current strategy
does not call for further development of AGI-1096 by us.
5
Collaborations
AstraZeneca Agreement
In 2005, we announced a license and collaboration agreement with AstraZeneca for the global
development and commercialization of AGI-1067. Under the terms of the agreement, we received a
license fee of $50 million. In April 2007, AstraZeneca notified us that pursuant to the terms of
the agreement, it was ending the collaboration. The agreement was terminated in July 2007.
Astellas Pharma Inc. (Formerly Known As Fujisawa Pharmaceutical Co., Ltd.) Agreement
In 2004, we announced a collaboration with Fujisawa Pharmaceutical Co., Ltd., now known as
Astellas Pharma Inc., to develop AGI-1096 as an oral treatment for the prevention of
organ transplant rejection. Under the agreement, we agreed to collaborate with Astellas to conduct
preclinical and early stage clinical development trials, with Astellas funding all development
costs during the term of the agreement. Astellas received an option to negotiate for late stage
development and commercial rights to the compound. Astellas has informed us that they have
completed their current development activities and do not presently have further development plans.
Discovery Research Program
We had built a Discovery Research Program using our demonstrated expertise in molecular
biology, cell biology, physiology, pharmacology, biochemistry and medicinal chemistry. After the
results of the ARISE trial, we suspended our discovery research activities and have focused on
elucidating the mechanism of action of AGI-1067 in diabetes. If our AGI-1067 program is successful,
we plan to reinitiate these activities with the following goals:
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To discover and develop v-protectants® with enhanced potency and improved
therapeutic properties. |
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To identify and develop new drug candidates based on promising therapeutic targets
identified by our or others drug discovery programs. |
Patents and Intellectual Property
We have established a patent portfolio of owned and in-licensed patents that cover our lead
compounds and their use. It is our goal to pursue both broad and specific patent protection in the
key areas of our research and development both in the United States and internationally, and to
identify value-added exclusive in-licensing opportunities.
V-Protectant® Technology
We have a license agreement with Emory University (Emory) covering aspects of our
v-protectant® technology.
Under the license agreement with Emory (the Emory License Agreement), Emory granted to us an
exclusive license to make, use and sell methods and products covered by certain patents and patent
applications owned by Emory relating generally to the treatment and diagnosis of VCAM-1 related
diseases. In August 2005, we amended the Emory License Agreement to provide that Emory will
receive a portion of any milestones or royalties received by us from third parties in exchange for
a reduced participation in future revenues and the elimination of milestone payments. We must
indemnify Emory for all claims and/or losses caused or contributed to by AtheroGenics arising out
of our use of the license. We have procured commercial general liability insurance in specified
amounts customary in the industry naming Emory as an insured
The Emory License Agreement will terminate on October 30, 2012; after that date, our payment
obligations under the Emory License Agreement will cease, and we will be entitled to continue to
use on a non-exclusive basis all inventions, data or other information described and claimed in the
licensed patents and the licensed technology. Emory may terminate the agreement if, after Emory
gives notice to us, we fail to make a payment, we fail to render progress reports, we incur
specified financial problems, we decide to no longer develop licensed products under the agreement,
or we breach a material term of the agreement. We may terminate the agreement upon advance notice
to Emory, or if Emory violates certain material terms of the agreement.
6
We previously had a license agreement with The Regents of the University of California in
which we received a license to make, use and sell diagnostic and therapeutic methods and products
using monoclonal antibodies in atherosclerosis and other diseases, which are claimed in applicable
patent applications owned by The Regents of the University of California in the U.S. and Canada.
We terminated the license agreement with The Regents of the University of California in 2007.
As part of our v-protectant® technology patent portfolio, we also purchased U.S.
Patent No. 5,262,439 under an agreement with Dr. Sampath Parthasarathy. The agreement provides for
the payment of a royalty equal to a certain percentage of the gross selling price paid to
AtheroGenics by a purchaser of any process, service or product in which any of the claimed
inventions of the patent is utilized as a necessary component. These payment obligations will
expire upon the last to expire valid claim in the jurisdiction where the patent is enforceable.
AGI-1067 Patent Portfolio
Our patent coverage on AGI-1067 is based on patent filings that we own and patent filings
exclusively licensed from Emory. We own one issued patent, U.S. Patent No. 5,262,439 and related
filings in Japan, Canada and Europe that generically cover the compound AGI-1067 as a member of a
class of related compounds. We own another patent, U.S. Patent No. 6,147,250, that protects the
specific compound AGI-1067 and its use to treat VCAM-1 mediated diseases including, among others,
atherosclerosis, post-angioplasty restenosis and coronary artery disease. We also own U.S. Patent
No. 6,121,319, which covers the use of a class of compounds including AGI-1067 to treat VCAM-1
mediated diseases. Patent applications corresponding to U.S. Patent No. 6,147,250 and U.S. Patent
No. 6,121,319 have also been filed in foreign patent offices and patents have issued in a number of
countries including Europe and Japan. The patents that we have exclusively licensed from Emory
include the use of a substance that inhibits a class of oxidant signals to treat diseases mediated
by VCAM-1.
AGI-1096 Patent Portfolio
Our patent coverage on AGI-1096 is based on patent filings that we own and patent filings
exclusively licensed from Emory. We own U.S. Patent No. 6,617,352 and associated non-U.S. patent
filings which describe AGI-1096 and its use to treat disorders mediated by VCAM-1. We also own
U.S. Patent No. 6,670,398 which claims methods of using AGI-1096 for treating transplant organ
rejection.
Other V-Protectant® Compounds
Certain patent applications in the United States and non-U.S. countries cover the use of a
number of compounds identified in our research program to act as v-protectants®, and
specifically for use in treating cardiovascular and inflammatory disease. In addition we have
exclusively licensed patents from Emory that cover the use of a class of compounds which act as
v-protectants®.
MEKK Technology
In June 2001, we entered into a worldwide exclusive license agreement with the National Jewish
Medical and Research Center. Under the agreement, National Jewish granted us an exclusive license
under several of its U.S. and foreign patents and patent applications and related technical
information to make, use and sell diagnostics and therapeutics for the treatment of human diseases,
including inflammation and asthma. In 2007, we terminated the MEKK Technology license agreement.
Our patent position, like that of many pharmaceutical companies, is uncertain and involves
complex legal and factual questions for which important legal principles are unresolved or unclear.
We may not develop or obtain rights to products or processes that are patentable. Even if we do
obtain patents, they may not adequately protect the technology we own or in-license. In addition,
others may challenge, seek to invalidate, infringe or circumvent any patents we own or in-license,
and rights we receive under those patents may not provide competitive advantages to us.
Our commercial success will depend in part on our ability to manufacture, use, sell and offer
to sell our product candidates and proposed product candidates without infringing patents or other
proprietary rights of others. We may not be aware of all patents or patent applications that may
impact our ability to make, use or sell any of our product candidates or proposed product
candidates. For example, U.S. patent applications do not publish until 18 months from their
effective filing date. Further, we may not be aware of published or granted conflicting patent
rights. Any conflicts resulting from patent applications and patents of others could significantly
reduce the coverage of our patents and limit our ability to obtain meaningful patent protection.
If others obtain patents
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with conflicting claims, we may be required to obtain licenses to these
patents or to develop or obtain alternative technology. We may not be able to obtain any licenses
or other rights to patents, technology or know-how necessary to conduct our business as described
in this report. Any failure to obtain such licenses or other rights could delay or prevent us from
developing or commercializing our product candidates and proposed product candidates, which could
materially affect our business.
Litigation or patent interference proceedings may be necessary to enforce any of our patents
or other proprietary rights, or to determine the scope and validity or enforceability of the
proprietary rights of others. The defense and prosecution of patent and intellectual property
claims are both costly and time consuming, even if the outcome is favorable to us. Any adverse
outcome could subject us to significant liabilities, require us to license disputed rights from
others, or require us to cease selling our future products.
Trademarks
The United States Patent and Trademark Office has issued to us Certificates of Registration
for the trademarks OXYKINE, AATHEROGENICS, AGI and V-PROTECTANT.
Manufacturing
We have entered into arrangements with third party manufacturers for the supply of AGI-1067
bulk drug substance and for the formulated drug product for use in our ongoing and currently
planned clinical trials. The suppliers of the bulk drug substance for AGI-1067 operate under
current Good Manufacturing Practice guidelines using cost-effective and readily available materials
and reliable processes. The starting material used in the manufacturing process of AGI-1067 is
Probucol USP, a material that is available from a number of suppliers worldwide. We have
sufficient quantities to support development activities for the foreseeable future. Another third
party supplier formulates AGI-1067 into the drug product under current Good Manufacturing Practice
guidelines. We anticipate that these suppliers will be able to provide sufficient formulated drug
product to complete our ongoing and currently planned clinical trials.
We plan to establish manufacturing agreements with third parties that comply with Good
Manufacturing Practice guidelines for bulk drug substance and formulations of our other
v-protectant® product candidates to support both ongoing and planned clinical trials as
well as commercial supply of the products following regulatory approval.
Sales and Marketing
As part of our long-term strategy, we plan to collaborate with large pharmaceutical companies
to commercialize products that we develop to target patient or physician populations in broad
markets. We believe that collaborating with large companies that have significant marketing and
sales capabilities provides for optimal penetration into broad markets, particularly those areas
that are highly competitive. Additionally, we plan to develop a sales force to promote or
co-promote our future products, including AGI-1067, to appropriate patient or physician populations
in target markets. By using our own sales and marketing organization for our products, we believe
we can retain a higher percentage of the profits generated from the sale of those products
Competition
Developments by others may render our product candidates obsolete or noncompetitive. We face
intense competition from other companies with pharmaceutical, biotechnology and medical device
companies for establishing relationships for collaborative arrangements with academic and research
institutes and for licenses to proprietary technology. These competitors, either alone or in
collaboration, may succeed in developing technologies or products that are more effective than
ours.
We believe pharmaceutical, biotechnology and medical device companies, as well as academic and
research institutions and government agencies, have drug discovery and development programs related
to our named therapeutic areas of interest. Many of these companies and institutions, including,
but not limited to, GlaxoSmithKline, Merck, Takeda and Lilly have targeted indications that overlap
significantly with our targets and have substantially greater resources, longer operating
histories, larger client bases and greater marketing and financial resources than we do. They may,
therefore, succeed in commercializing products before we do that compete with us on the basis of
efficacy, safety and price.
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Our ability to compete is predicated on three related factors:
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First, our scientists and their collaborators have pioneered the basic
discoveries and research methodologies linking oxidant signals to cell inflammation.
These discoveries and research methodologies form the foundation for our proprietary
drug discovery programs relating to chronic inflammation. |
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Second, our scientific expertise, coupled with our expertise in clinical drug
development, has enabled us to be the first company to conduct clinical trials of an
orally-administered, small molecule v-protectant®. |
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Third, we believe our scientific, development and licensing expertise strongly
positions us to acquire promising technologies and products discovered outside
AtheroGenics. |
Governmental Regulation
We plan to develop prescription-only drugs for the foreseeable future. The FDA is the
regulatory agency in the United States that is charged with the protection of people who take
prescription medicines. Every country has a regulatory body with a similar mandate. The European
Union (EU) has vested centralized authority in the European Medicines Evaluation Agency and the
Committee for Medicinal Products for Human Use to standardize review and approval across EU member
nations.
These regulatory agencies enforce comprehensive statutes, regulations and guidelines governing
the drug development process. This process involves several steps. First, the drug company must
generate preclinical data to show safety before human testing may be initiated. In the United
States, the drug company must submit an Investigational New Drug application (IND) to the FDA
prior to securing authorization for human testing. The IND must contain adequate data on product
candidate chemistry, toxicology and metabolism and, where appropriate, animal research testing to
support initial safety evaluation in humans. In addition, the drug company must provide the FDA
with a clinical study plan, including protocols specifying the proposed use and testing of the drug
in healthy volunteers and patients.
Clinical trials for a new product candidate ordinarily proceed through three phases, and may
extend into a fourth phase:
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Phase I clinical trials explore safety, blood levels, metabolism and the
potential for interaction with other drugs. Phase I typically proceeds from healthy
volunteers to patients with the target disease. The study population during Phase I can
include up to approximately 200 total subjects. |
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Phase II clinical trials further support safety, and they establish the dose(s)
or strength(s) of the drug to be used in the more extensive clinical investigations to
be conducted during Phase III. These Phase II clinical trials may include hundreds of
patients who have the target disease and who are receiving a range of background
medications. In addition, Phase II clinical trials often verify the mechanisms of
action proposed pre-clinically. |
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Phase III clinical trials usually include at least two adequate and well
controlled studies in the target population. For most chronic diseases, drug companies
study a few thousand patients to assure a broadly applicable assessment of safety and
efficacy |
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At the successful conclusion of Phase III, drug companies may submit a product license
application, called an NDA in the United States. The FDA, or non-U.S. regulatory
authorities, review the application for completeness, accuracy and adherence to
regulations. These authorities may use consultants to assist in the evaluation of the
data, and may convene an expert committee to advise on the safety, effectiveness and
usefulness of the proposed new product candidate prior to final regulatory judgment.
The final step to registration is development and approval of the prescribing
information that is incorporated in labeling, usually referred to as the package insert,
that accompanies the marketed drug. This labeling establishes conditions for the safe
and effective use of the drug and the content of drug company promotion and advertising
to physicians who may use the new drug. Approval of the NDA may be conditioned on the
conduct of post-approval studies, or Phase IV studies. |
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Phase IV clinical trials provide additional information to support marketing of
the drug for its approved indication. Phase IV clinical trials may generate data to
support promotion of the new drug in comparison with other approved drugs and to support
healthcare economics claims. In addition, every pharmaceutical company is responsible
for post-marketing surveillance for safety in the marketplace. |
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Clinical trials, including the adequate and well controlled clinical investigations conducted
in Phase III, are designed and conducted in a variety of ways. These Phase III studies are often
randomized, placebo-controlled and double-blinded. A placebo-controlled trial is one in which
one group of patients, referred to as an arm of the trial, receives the drug being tested and
another group receives a placebo, which is a substance known not to have pharmacologic or
therapeutic activity. In a double-blind study, neither the researcher nor the patient knows
which arm of the trial is receiving the drug or the placebo.
Randomized means that upon enrollment patients are placed into one arm or the other at random by computer. Other
controls also may be used by which the test drug is evaluated against a comparator. For example,
parallel control trials generally involve studying a patient population that is not exposed to
the study medication (i.e., is either on placebo or standard treatment protocols). In such studies
experimental subjects and control subjects are assigned to groups upon admission to the study and
remain in those groups for the duration of the study. Not all studies are highly controlled. An
open label study is one where the researcher and the patient know that the patient is receiving
the drug. A trial is said to be pivotal if it is designed to meet statistical criteria with
respect to pre-determined endpoints, or clinical objectives, that the sponsor believes, based
usually on its interactions with the relevant regulatory authority, will be sufficient to
demonstrate safety and effectiveness meeting regulatory approval standards.
Regulatory authorities, institutional review boards overseeing studies, or the sponsor may
suspend a clinical trial at any time on various grounds, including a finding that the subjects or
patients are being exposed to an unacceptable health risk.
The FDA may require, or companies may pursue, additional clinical trials after a product is
approved. So-called Phase IV studies may be a condition of NDA approval to be satisfied after a
drug is commercially available. The results of Phase IV studies can confirm the effectiveness of a
product candidate and can provide important safety information to augment the FDAs voluntary
adverse drug reaction reporting system.
The results of product development, pre-clinical studies and clinical trials are submitted to
the FDA as part of an NDA for an unapproved drug candidate, or as part of an NDA supplement if the
drug product is already approved. Supplemental applications are submitted for various reasons,
including new indications for use and new strengths. The FDA may deny approval of an NDA or NDA
supplement if applicable regulatory criteria are not satisfied. In such cases, the FDA often
concludes that additional clinical data, particularly from new pivotal studies, are needed. Even
if such data are submitted, the FDA may ultimately decide that the NDA or NDA supplement does not
satisfy the criteria for approval. Once an approval is issued, the FDA may withdraw product
approval if ongoing regulatory standards are not met or if safety problems occur after the product
reaches the market. In addition, the FDA may require testing and surveillance programs to monitor
the effect of approved products that have been commercialized, and the FDA has the power to prevent
or limit further marketing of a product based on the results of these post-marketing programs.
Satisfaction of FDA requirements, or similar requirements of foreign regulatory agencies,
typically takes several years. The time required may vary substantially based upon the type,
complexity and novelty of the product or disease. Typically, if a drug product is intended to
treat a chronic disease, as is the case with the product candidates we are developing, safety and
efficacy data must be gathered over an extended period of time, which can range from six months to
three years or more. Government regulation may delay or prevent marketing of product candidates or
new drugs for a considerable period of time and impose costly limits upon our activities. We
cannot be certain that the FDA or any other regulatory agency will grant approvals for any
indications for our product candidates on a timely basis, if at all. Success in early stage
clinical trials does not ensure success in later stage clinical trials. Data obtained from
clinical activities is not always conclusive and may be susceptible to varying interpretations,
which could delay, limit or prevent regulatory approval. Even if a product candidate receives
regulatory approval, the approval may be significantly limited to specific disease states, patient
populations and dosages. Further, even after regulatory approval is obtained, later discovery of
previously unknown problems with a product may result in restrictions on the product or even
complete withdrawal of the product from the market. In addition, we cannot predict what adverse
governmental regulations may arise from future United States or foreign governmental action.
The FDA closely regulates the marketing and promotion of drugs. A company can make only those
claims relating to safety and efficacy that are consistent with labeling approved by the FDA.
Failure to comply with these requirements can result in adverse publicity, warning letters,
corrective advertising and potential civil and criminal penalties.
The FDAs policies may change and additional government regulations may be enacted that could
prevent or delay regulatory approval of our product candidates or approval of new indications for
our existing products. We cannot predict the likelihood, nature or extent of adverse governmental
regulation that might arise from future legislative or administrative action, either in the United
States or abroad.
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We must meet regulatory standards prior to exposing subjects to any drug candidate. We remain
responsible for any of these development activities whether we perform them internally or contract
them to a third party. The FDA may audit us or our third party contractors at any time to
ascertain compliance with standards. The FDA may halt all ongoing work if it determines that we or
our contractors have deviated significantly from these standards. These standards include:
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Good Manufacturing Practices (GMP), which govern the formulation, manufacture,
testing, labeling, packaging, release and monitoring of a drug throughout its life
cycle; |
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Good Laboratory Practices, which govern the use of a drug in animal studies to
support establishment of safety or the disposition and metabolism of the administered
drug, and handling of human or other biological samples for drug assays; and |
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Good Clinical Practices, which govern the exposure of human subjects under our
investigational protocols. Good Clinical Practices set standards for the constitution
and activities of institutional review boards and clinical investigators that are
charged with assuring that the appropriate person gives informed consent prior to study
participation, protecting patients whether they receive an experimental drug, an
approved drug or a placebo, controlling and accounting for investigational drug
products, and producing timely and accurate study records. |
Any products manufactured or distributed by us pursuant to FDA approvals are subject to
continuing regulation by the FDA, including record-keeping requirements and reporting of adverse
experiences with the drug. Drug manufacturers and their contractors involved in the manufacture of
drug components or the required testing of the drug or its components are required to register
their establishments with the FDA and certain state agencies. As registered establishments, they
are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with current GMP. These inspections are intended to assure that facilities are
appropriately qualified and maintained, personnel are properly experienced and trained, procedural
and documentation requirements are satisfied, and product meets established specifications. We
cannot be certain that we or our present or future suppliers will be able to comply with the
current GMP and other FDA regulatory requirements. If our present or future suppliers are not able
to comply with these requirements, the FDA may halt our clinical trials, require us to recall a
drug from distribution or withdraw approval of the NDA for that drug.
The FDA has expanded its expedited review process in recognition that certain severe or
life-threatening diseases and disorders have only limited treatment options. Fast track
designation expedites the development process, but places greater responsibility on a drug company
during Phase IV clinical trials. The drug company may request fast track designation for one or
more indications at any time during the IND process, and the FDA must respond within 60 days. Fast
track designation allows the drug company to develop product candidates faster based on the ability
to request an accelerated approval of the NDA. For accelerated approval the clinical effectiveness
is based on a surrogate endpoint in a smaller number of patients. In addition, the drug company
may request priority review at the time of the NDA submission. If the FDA accepts the NDA
submission as a priority review, the time for review is reduced from one year to six months. We
plan to request fast track designation and/or priority review, as appropriate, for internal drug
development programs.
In addition, our research and development processes and manufacturing activities involve the
controlled use of hazardous materials, chemicals and radioactive materials and produce waste
products. We are subject to federal, state and local laws and regulations governing the use,
manufacture, storage, handling and disposal of hazardous materials and waste products.
Drug promotion and advertising are subject to FDA and other regulatory oversight in the United
States and national review elsewhere. In addition, state and local governments and other federal
agencies may control manufacturing, distribution, or disposal subject to local regulation.
Research and Development
Our research and development expenses in 2007, 2006 and 2005 were $72.7 million, $82.9 million
and $71.3 million, respectively. We plan to focus our near-term research and development efforts
on the continued development of AGI-1067 for the treatment of patients with type 2 diabetes.
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Employees
As of February 25, 2008, we had 57 full-time employees, including 35 in research and
development. The employee group includes 13 employees with Ph.D. degrees, four with M.D. degrees
and 12 with Masters degrees. We believe that our employee relations are good.
Available Information
Our internet website is located at www.atherogenics.com. Copies of our reports filed
under Section 13(a) or 15(d) of the Exchange Act, including annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K and all amendments to these reports, may be
accessed from our website, free of charge, as soon as reasonably practicable after these reports
are electronically filed with or furnished to the Securities and Exchange Commission. The
reference to our website address does not constitute incorporation by reference of the information
contained on the website, which should not be considered part of this document. Additionally, you
may read and copy materials that we file with the SEC at the SECs Public Reference Room at 100 F
Street, N.E. Washington, D.C. 20549. You can obtain information on the operation of the Public
Reference Room by calling the SEC at 1-800-SEC-0330.
Item 1A. Risk Factors
Forward-Looking Statements and Risks Related to Our Company and Business
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for
forward-looking statements made by or on behalf of AtheroGenics. AtheroGenics and its
representatives may from time to time make written or oral forward-looking statements, including
statements contained in this report and our other filings with the Securities and Exchange
Commission and in our reports to our shareholders. Generally, the words, believe, expect,
intend, estimate, anticipate, will and similar expressions identify forward-looking
statements. All statements which address operating performance, events or developments that we
expect or anticipate will occur in the future, including projections of our future results of
operations or of our financial condition, research, development and commercialization of our
product candidates, expected timing regarding the completion of our clinical trials and the related
release of results and anticipated trends in our business, are forward-looking statements within
the meaning of the Reform Act. The forward-looking statements are and will be based on our then
current views and assumptions regarding future events and operating performance, and speak only as
of their dates. We undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
The following are some of the factors that could affect our financial performance or could
cause actual results to differ materially from those expressed or implied in our forward-looking
statements:
Risks Related to Our Financial Results, Liquidity and Need for Additional Financing
We have $30.5 million of convertible notes maturing in September 2008 and will require
additional funds for operations in 2009. If we are unable to raise additional capital, enter
into a collaboration agreement for AGI-1067 or restructure these notes, we may seek relief under
the Bankruptcy Code at some point in the future.
As of February 25, 2008, approximately $30.5 million of our 4.5% Convertible Notes due 2008 (the
2008 Notes) were outstanding, which amount will become due September 1, 2008. Although we
expect to have enough cash on hand to repay all amounts due pursuant to our 2008 Notes, this
repayment will leave us with substantially less cash to fund our ongoing operations during 2009.
To the extent we cannot raise additional capital before or after the maturity date of the 2008
Notes, enter into collaboration arrangements to fund the development
and commercialization of AGI-1067 or restructure the 2008 Notes before they become due, we
may seek relief under Title 11 of the U.S. Code (the Bankruptcy Code) at some point in the
future, which would substantially dilute and may eliminate the interests of the holders of our
common stock. If we seek relief under the Bankruptcy Code, we may be unable to complete
development of AGI-1067 or our other product candidates.
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We may not maintain our qualification for continued listing on the Nasdaq Global Market or
another national securities exchange, which would allow the holders of our outstanding
convertible notes to require us to redeem the notes at face value, and effectively require us to
seek relief under the Bankruptcy Code.
On November 28, 2007, we received a Nasdaq Staff Deficiency Letter indicating that we had
failed to comply with the requirements for continued listing set forth in Nasdaq Marketplace Rule
4450(b)(1)(A) because the market value of our listed securities had fallen below $50 million for 10
consecutive business days. On January 2, 2008, we received a Nasdaq Staff Determination Letter
indicating that we had not cured the failure to comply with Marketplace Rule 4450(b)(1)(A). We
have had a hearing on this deficiency on February 7, 2008 and Nasdaq informed us that we will
regain compliance with Marketplace Rule 4450(b)(1)(A) on the basis of this Form 10-K demonstrating
total assets and total revenue in excess of $50 million for our 2007 fiscal year.
On December 26, 2007, we received a second Nasdaq Staff Deficiency Letter indicating we had
failed to comply with the requirements for continued listing set forth in Nasdaq Marketplace Rule
4450(b)(4) because the closing bid price of our common stock had fallen below $1.00 for 30
consecutive business days. We have been provided 180 calendar days to regain compliance with this
rule. If at any time before the end of the 180 calendar day compliance period, our common stock
closes at $1.00 or more for a minimum of 10 consecutive business days, Nasdaq will provide written
notification that we are in compliance with the minimum bid price requirement.
Under the terms of the indentures governing our outstanding convertible notes, if our common
stock fails to be listed on the Nasdaq Global Market or another national securities exchange, each
holder of the notes will have the right to require us to redeem the notes at face value. As of
February 25, 2008, we had $302.4 million of convertible notes outstanding. If the holders of a
sufficient amount of the convertible notes exercise their right to require us to redeem the notes,
we would not be able to pay the redemption price and we would be in default on the full outstanding
amount and would be subject to the acceleration of all $302.4 million of convertible notes. If the
maturity of the outstanding notes were accelerated we would attempt to refinance or restructure
these obligations. However, we cannot assure you that such efforts would be successful, in which
case we would not have sufficient liquidity to fund near term operations and we would seek relief
under the Bankruptcy Code, which would substantially dilute and may eliminate the interests of the
holders of our common stock.
In addition, a delisting may negatively impact the value of our common stock, as our stock
will likely be less liquid and trade with larger variations between the bid and ask price. We
could lose support from institutional investors, brokerage firms and market makers, if any, that
currently buy and sell our common stock. In addition, a delisting could also adversely affect our
ability to obtain financing for the continuation of our operations or to use our stock in
acquisitions. A delisting could also result in loss of confidence by our suppliers, customers and
employees.
We have a history of operating losses, and we may not generate revenue or achieve profitability
in the future.
Our ability to generate revenue and achieve profitability depends on our ability, alone
or with collaborators, to complete successfully the development of our product candidates, conduct
preclinical tests and clinical trials, obtain the necessary regulatory approvals and manufacture
and market the resulting drugs. We have had no product revenue to date. We have experienced
operating losses since we began operations in 1994. As of December 31, 2007, we had an accumulated
deficit of approximately $411.5 million. We expect to incur additional operating losses and expect
cumulative losses to increase as our research and development, preclinical, clinical, manufacturing
and marketing efforts expand. If we are unable to achieve and then maintain profitability, the
market value of our common stock and our outstanding notes will decline.
Risks Related to Development and Commercialization of Product Candidates and Dependence on Third
Parties
We depend heavily on the success of our most advanced internal product candidate, AGI-1067 for
diabetes, which is in clinical development. If we are unable to commercialize this product
candidate, or experience significant delays in doing so, our business will be materially harmed.
AGI-1067 is our lead compound. Our ability to generate product revenues will depend
heavily on the successful development and commercialization of this compound. The commercial
success of AGI-1067 will depend on several factors, including the following:
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successful completion of clinical trials; |
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receipt of marketing approvals from the FDA and similar foreign regulatory authorities; |
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successfully preparing for, and sustaining, commercial manufacturing and distribution
arrangements with third party manufacturers, including our third party collaborators; |
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commencing commercial sales of the product, in collaboration with third parties; and |
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acceptance of the product in the medical community and with third party payors. |
AGI-1067 could fail in clinical trials if we are unable to show that it is effective or if it
causes unacceptable side effects in the patients we treated.
In March 2007, we announced that our ARISE Phase III clinical study of AGI-1067 did not show a
difference from placebo in its composite primary endpoint. The failure to meet the primary
endpoint in our ARISE Phase III clinical study could have a material adverse effect on our ability
to commercialize AGI-1067, generate revenue or become profitable.
In May 2007, we announced that we intended to conduct ANDES, a multi-center, double-blind
study with 6-month dosing across a range of doses, designed to compare the effects of AGI-1067
versus placebo on glycemic endpoints in subjects with confirmed type 2 diabetes. AGI-1067
could fail in the ANDES trial if we are unable to show that it is effective or if it causes
unacceptable side effects in the patients we treated. We commenced ANDES with 6-month dosing of
AGI-1067 in 300 mg, 150 mg and 75 mg strengths. After discussions with the FDA about the overall
risk/benefit profile of the 300mg dose, the 300 mg dose was discontinued in the ANDES trial and we
continued ANDES with the 150 mg and 75 mg doses. Much of the clinical data generated to date
regarding AGI-1067 is based upon the results of our ARISE clinical trial, which evaluated the
impact of AGI-1067 on a composite measure of heart disease outcomes and used a 300 mg dose of
AGI-1067. The 300 mg dose of AGI-1067 used in ARISE resulted in an observed increase in abnormal
liver function tests in a small number of patients compared to those on standard of care and one
case of liver failure in the treatment group. All incidents of liver dysfunction reversed when
treatment was discontinued. There can be no assurance that the lower dosage to be used in ANDES
will not have similar side effects. If we are not successful in commercializing AGI-1067, or are
significantly delayed or limited in doing so, our financial results and our commercial prospects
will be materially harmed.
If we do not successfully develop other product candidates, we will have limited ability to
generate revenue.
Other than AGI-1067, all of our other current product candidates are in early stages of
development, and only one other product candidate has undergone Phase I clinical trials. Our
product candidates are subject to the risks of failure inherent in developing drug products based
on new technologies. We do not expect any of our potential product candidates, including AGI-1067,
to be commercially available (if at all) before 2011. Our drug discovery efforts may not produce
any other proprietary product candidates. While we will continue to attempt to acquire or
in-license other product candidates, there is no assurance that we will be able to do so. Our
failure to develop product candidates will limit our ability to generate additional revenue.
If we fail to demonstrate adequately the safety and efficacy of a product candidate, we will not
be able to commercialize that product candidate.
Product candidates we develop, alone or with others, may not prove safe and effective
for the intended use in clinical trials and may not meet all of the applicable regulatory
requirements needed to receive regulatory approval. If we fail to adequately demonstrate safety
and efficacy for any product candidate, we will not be able to commercialize that product
candidate. Our failure to commercialize a product candidate will materially adversely affect our
revenue opportunities. We will need to conduct significant research, preclinical testing and
clinical trials before we can file product approval applications with the FDA and similar
regulatory authorities in other countries. Preclinical testing and clinical trials are long,
expensive and uncertain processes. We may spend several years completing our testing for any
particular product candidate. Failure can occur at any stage.
The FDA, institutional review boards (IRBs) at the medical institutions and healthcare
facilities where we sponsor clinical trials, or we may suspend our clinical trials at any time if
either of us believes that we are exposing the subjects participating in these trials to
unacceptable health risks. The FDA or IRBs may suspend any trial indefinitely if they find
deficiencies in the conduct of these trials.
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The FDA and these IRBs have authority to oversee our clinical trials, and the FDA may require large
numbers of test subjects. In addition, we must manufacture the product candidates that we use in
our clinical trials under the FDAs Good Manufacturing Practices.
Even if we achieve positive results in early clinical trials or in interim analyses of a
trial, these results do not necessarily predict final results. A number of companies in the
pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after
achieving positive results in earlier trials. Negative or inconclusive results or adverse medical
events during a clinical trial could cause the FDA or us to terminate a clinical trial or require
that we repeat it.
In addition, even if we receive approval for commercial sale of any of our product
candidates, after use in an increasing number of patients, our products could show side effect
profiles or other characteristics that limit their usefulness or require their withdrawal although
the drugs did not show those profiles or characteristics in earlier clinical trials.
We may not be successful in establishing collaborations for product candidates we may seek to
commercialize, which could adversely affect our ability to discover, develop and commercialize
products.
A key element of our business strategy is to collaborate with third parties,
particularly leading pharmaceutical companies, to develop and commercialize some of our product
candidates. We expect to seek collaborations for the development and commercialization of product
candidates in the future. The timing and terms of any collaboration will depend on the evaluation
by prospective collaborators of the trial results and other aspects of the drugs safety and
efficacy profile.
We had previously entered into a collaboration with AstraZeneca for the development and
commercialization of AGI-1067. The agreement was terminated in July 2007. If we are unable to
reach agreements with other suitable collaborators for any product candidate, we would be forced to
fund the entire development and commercialization of such product candidates, and we may not have
the resources to do so. In addition, if resource constraints require us to enter into a
collaboration early in the development of a product candidate, we may be forced to accept a more
limited share of any revenues this product may eventually generate. We face significant
competition in seeking appropriate collaborators. Moreover, these collaboration arrangements are
complex and time-consuming to negotiate and document. We may not be successful in our efforts to
establish collaborations or other alternative arrangements for any product candidate. Even if we
are successful in establishing collaborations, we may not be able to ensure fulfillment by
collaborators of their obligations or our expectations.
We expect to depend on collaborations with third parties to develop and commercialize some of
our product candidates. If a potential collaborator were to change its strategy or the focus of
its development and commercialization efforts with respect to our relationship, the success of
our product candidates and our operations could be adversely affected.
We intend to pursue collaborations in the future with large pharmaceutical companies to
commercialize products that we develop to target patient or physician populations in broad markets.
Any collaboration that we may establish may not be successful. The success of any collaboration
arrangement will depend heavily on the efforts and activities of our collaborators. Collaborators
will likely have significant discretion in determining the efforts and resources that they will
apply to these collaborations. The risks that we anticipate being subject to in collaborations
include:
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a collaborator may develop and commercialize, either alone or with others, products and
services that are similar to or competitive with the products that are the subject of the
collaboration with us; |
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a collaborator may change the focus of its development and commercialization efforts.
Pharmaceutical and biotechnology companies historically have re-evaluated their priorities
from time to time, including following mergers and consolidations, which have been common in
recent years in these industries; |
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the ability of our product candidates and products to reach their potential could be
limited if our collaborators decrease or fail to increase spending relating to these
products; |
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a collaborator may terminate a collaboration; |
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a collaborator may fail to achieve or remain in regulatory compliance; and |
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a collaborator may fail to maintain or defend our intellectual property rights. |
The termination of any collaboration that we may establish might adversely affect the
development of the related product candidates and our ability to derive revenue from them.
Collaborations with pharmaceutical companies and other third parties often are terminated or
allowed to expire by the other party or by us. Any future terminations or expirations would
adversely affect us financially and could harm our business reputation. In that event, we might be
required to devote additional resources to the product or product candidate, seek a new
collaborator or abandon the product or product candidate, any of which could have an adverse effect
on our business.
Third parties failure to synthesize and manufacture our product candidates to our
specifications could delay our clinical trials or hinder our commercialization prospects.
We currently have no manufacturing facilities to synthesize or manufacture our product
candidates, nor do we intend to develop these capabilities in the near future. Our reliance on
third parties for these services exposes us to various risks that could delay our clinical trials
or hinder our commercialization prospects. These risks include the following:
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A finding that a third party did not comply with applicable governmental regulations.
Manufacturers of pharmaceutical products are subject to continual review and periodic
inspections by regulatory agencies. Our present or future manufacturers may not be able to
comply with the FDAs current Good Manufacturing Practices regulations and other FDA
regulatory requirements or similar regulatory requirements outside the United States.
Failure of one of our third party manufacturers to comply with applicable regulatory
requirements, whether or not related to our product candidates, could result in sanctions
being imposed on us, including fines, injunctions, civil penalties, failure of regulatory
authorities to grant marketing approval of our product candidates, delays, suspension or
withdrawal of approvals, license revocation, seizures or recalls of product candidates or
products, operating restrictions and criminal prosecutions, any of which could significantly
and adversely affect supplies of our product candidates and products. |
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A failure to synthesize and manufacture our product candidates in accordance with our
product specifications. We need to maintain a very low maximal amount of one of the
starting materials used in the manufacture of AGI-1067. The starting material, probucol,
was prescribed by physicians as a cholesterol-lowering agent until its manufacturer withdrew
the drug from the market for efficacy reasons. A failure by a third party manufacturer to
maintain an acceptable level of probucol in the manufacture of AGI-1067 may result in
chronic dosing of probucol, which is associated with the occurrence of a rare side effect. |
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A failure to deliver product candidates in sufficient quantities or in a timely manner.
Any failure by a third party manufacturer to supply our requirements for clinical trial
materials or commercial product, or to supply these materials in a timely manner, could
jeopardize the initiation or completion of clinical trials or could have a material adverse
effect on our ability to commercialize any approved products and thereby generate revenue. |
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Termination or nonrenewal of an agreement by a third party at a time that is costly or
inconvenient to us. Our product candidates and any products that we successfully develop
may compete with product candidates and products of others for access to the third partys
manufacturing facilities. In addition, because we do not have any internal manufacturing
capabilities, the termination of a supply or manufacturing agreement could severely impair
our ability to manufacture our products and could have a material adverse effect on our
financial condition and operating results. |
The commercial success of any products that we may develop will depend on the degree of market
acceptance by physicians, patients, healthcare payors and others in the medical community.
Any products that we bring to the market may not gain market acceptance by physicians,
patients, healthcare payors and others in the medical community. If these products do not achieve
an adequate level of acceptance, we may not generate material product revenues and we may not
become profitable. The degree of market acceptance of our product candidates, if approved for
commercial sale, will depend on a number of factors, including:
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the prevalence and severity of any side effects; |
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the efficacy and potential advantages over alternative treatments; |
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the ability to offer our product candidates for sale at competitive prices; |
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relative convenience and ease of administration; |
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the willingness of the target patient population to try new therapies and of physicians
to prescribe these therapies; |
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the strength of marketing and distribution support; and |
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sufficient third party coverage or reimbursement. |
If our competitors develop and market products that are more effective, have fewer side effects
or are less expensive than our current or future product candidates, we may have limited
commercial opportunities.
The development and commercialization of new drugs is highly competitive. Our
competitors include large pharmaceutical and more established biotechnology companies. Moreover,
there are approved products on the market for the diseases for which we are developing drugs. In
many cases, these products have well known brand names, are distributed by large pharmaceutical
companies and have achieved widespread acceptance among physicians and patients. Our competitors
have significant resources and expertise in research and development, manufacturing, testing,
obtaining regulatory approvals and marketing. Potential competitors also include academic
institutions, government agencies, and other public and private research organizations that conduct
research, seek patent protection and establish collaborative arrangements for research,
development, manufacturing and commercialization. Any of these competitors could develop
technologies or products that would render our technologies or product candidates obsolete or
non-competitive, which could adversely affect our revenue potential. These third parties also
compete with us in recruiting and retaining qualified scientific and management personnel,
establishing clinical trial sites and patient registration for clinical trials, as well as in
acquiring technologies complementary to or necessary for our programs or advantageous to our
business.
We have not previously sold, marketed or distributed any products and may not be able to
successfully commercialize AGI-1067, or other drug candidates.
We have not previously sold, marketed or distributed any products and currently have no sales
or distribution capabilities. As our drug candidates progress towards ultimate commercialization,
we will need to develop our sales and marketing capabilities and enter into agreements with third
parties to perform these functions. We may be unable to successfully hire and retain key sales and
marketing personnel that we need to effectively manage and carry out the commercialization of
AGI-1067, or any other drug candidates. Even if we manage to hire and retain necessary personnel,
we may be unable to implement our sales, marketing and distribution strategies effectively or
profitably. We have no experience in developing, training or managing a sales force and will incur
substantial additional expenses in doing so. The cost of establishing and maintaining a sales
force may exceed its cost effectiveness. In addition, we will compete with many companies that
currently have extensive and well-funded marketing and sales operations. In the event that
AGI-1067 or another of our drug candidates is not approved for marketing by the FDA, we may have
incurred expenses for the buildup of a sales force that we may not be able to recover.
If we are unable to obtain adequate coverage and reimbursement from third party payors for any
products that we may develop or acceptable prices for those products, our revenues and prospects
for profitability will suffer.
Most patients rely on government payors, such as Medicare or Medicaid, private health
insurers or other third party payors to pay for their medical needs, including any pharmaceutical
products that we or any collaborators may bring to the market. If government or other third party
payors do not provide adequate coverage and reimbursement for any products that we might develop,
our revenues and prospects for profitability will suffer. In December 2003, the Congress enacted
the Medicare Prescription Drug and Modernization Act, which significantly expanded Medicare
coverage of prescription drugs by establishing Medicare Part D, a voluntary, limited outpatient
prescription drug program, which went into effect on January 1, 2006. The advent of the Part D
program might increase coverage for Medicare beneficiaries and thereby increase demand for our
products, however, Part D prescription drug plans will have substantial leverage in negotiating the
payments for drugs furnished through the program. This might result in lower payments for products
that are covered through the Part D program than we might otherwise obtain from private plans.
Price concessions that we provide to Part D plans could adversely impact our pricing with
non-Medicare third party payors.
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A primary trend in the United States healthcare industry is toward cost containment.
Third party payors increasingly are challenging the prices charged for medical products and
services, and many third party payors limit coverage and reimbursement for newly-approved
healthcare products. In particular, third party payors might limit the indications for which they
will provide coverage for products that we develop or provide coverage barriers such as requiring
prior approval from the health plan based on a patients diagnosis and a physicians letter of
medical necessity. Cost control initiatives by payors could decrease the price we might establish
for products that we might develop, which could result in lower product revenues to us.
In addition, in some foreign countries, particularly the countries of the European Union, the
pricing of prescription pharmaceuticals is subject to governmental control. In these countries,
pricing negotiations with governmental authorities can take six to 12 months or longer after the
receipt of regulatory marketing approval for a product. To obtain reimbursement or pricing
approval in some countries, we may be required to conduct a clinical trial that compares the cost
effectiveness of our product candidates or products to other available therapies. The conduct of
such a clinical trial could be expensive and result in delays in commercialization of our products.
If plaintiffs bring product liability lawsuits against us, we may incur substantial financial
loss or may be unable to obtain future product liability insurance at reasonable prices, if at
all, either of which could diminish our ability to commercialize our future products.
The testing and marketing of medicinal products entail an inherent risk of product
liability. Even if we perform careful clinical development, we cannot predict the full range of
adverse consequences that might be associated with the use, misuse, or abuse of our products. We
also must remain highly vigilant to emerging information and trends that may concern our products.
Clinical trial subjects, consumers, healthcare providers or pharmaceutical companies or others
selling our future products could bring product liability claims against us. If we cannot
successfully defend ourselves against claims that our product candidates or products caused
injuries, we will incur substantial liabilities. Regardless of merit or eventual outcome,
liability claims may result in:
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decreased demand for any product candidates or products that we may develop; |
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injury to our reputation; |
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withdrawal of clinical trial participants; |
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costs to defend the related litigation; |
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substantial monetary awards to trial participants or patients; |
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loss of revenue; and |
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the inability to commercialize any products that we may develop. |
We may not be able to acquire or maintain insurance coverage at a reasonable cost or in sufficient
amounts to protect us from this kind of liability.
Risks Related to Our Intellectual Property
Our failure to protect adequately or enforce our intellectual property rights or secure rights
to third party patents could materially adversely affect our proprietary position in the
marketplace or prevent the commercialization of our products.
Our success will depend in large part on our ability to obtain and maintain protection
in the United States and other countries for the intellectual property covering or incorporated
into our technologies and products. The patents and patent applications in our patent portfolio
are either owned by us or licensed to us. Our ability to protect our product candidates from
unauthorized or infringing use by third parties depends substantially on our ability to obtain and
maintain valid and enforceable patents. Due to evolving legal standards relating to the
patentability, validity and enforceability of patents covering pharmaceutical inventions and the
scope of claims made under these patents, our ability to obtain and enforce patents is uncertain
and involves complex legal and factual questions for which important legal principles are
unresolved.
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We may not be able to obtain patent rights on products, treatment methods or
manufacturing processes that we may develop or to which we may obtain license or other rights.
Even if we do obtain patents, rights under any issued patents may not provide us with sufficient
protection for our product candidates or provide sufficient protection to afford us a commercial
advantage against our competitors or their competitive products or processes. It is possible that
no patents will be issued from any pending or future patent applications owned by us or licensed to
us. Others may challenge, seek to invalidate, infringe or circumvent any patents we own or
license. Alternatively, we may in the future be required to initiate litigation against third
parties to enforce our intellectual property rights. The cost of this litigation could be
substantial and our efforts could be unsuccessful. Changes in either patent laws or in
interpretations of patent laws in the United States and other countries may diminish the value of
our intellectual property or narrow the scope of our patent protection.
Our patents also may not afford us protection against competitors with similar
technology. We may not have identified all patents, published applications or published literature
that affect our business either by blocking our ability to commercialize our product candidates, by
preventing the patentability of our drugs to us or our licensors or by covering the same or similar
technologies that may affect our ability to market our product candidates. For example, patent
applications in the United States are maintained in confidence for up to 18 months after their
filing. In some cases, however, patent applications remain confidential in the United States
Patent and Trademark Office for the entire time prior to issuance as a United States patent. Patent
applications filed in countries outside the United States are not typically published until at
least 18 months from their first filing date. Similarly, publication of discoveries in the
scientific or patent literature often lags behind actual discoveries. Therefore, we or our
licensors might not have been the first to invent, or the first to file, patent applications on our
drug candidates or for their use. The laws of some foreign jurisdictions do not protect
intellectual property rights to the same extent as in the United States and many companies have
encountered significant difficulties in protecting and defending these rights in foreign
jurisdictions. If we encounter such difficulties in protecting or are otherwise precluded from
effectively protecting our intellectual property rights in foreign jurisdictions, our business
prospects could be substantially harmed.
If we infringe or are alleged to infringe intellectual property rights of third parties, it will
adversely affect our business.
Our research, development and commercialization activities, as well as any product
candidates or products resulting from these activities, may infringe or be claimed to infringe
patents or patent applications under which we do not hold licenses or other rights. Third parties
may own or control these patents and patent applications in the United States and abroad. These
third parties could bring claims against us or our collaborators that would cause us to incur
substantial expenses and, if successful against us, could cause us to pay substantial damages.
Further, if a patent infringement suit were brought against us or our collaborators, we or they
could be forced to stop or delay research, development, manufacturing or sales of the product or
product candidate that is the subject of the suit.
As a result of patent infringement claims, or in order to avoid potential claims, we or
our collaborators may choose or be required to seek a license from the third party and be required
to pay license fees or royalties or both. These licenses may not be available on acceptable terms,
or at all. Even if we or our collaborators were able to obtain a license, the rights may be
nonexclusive, which could result in our competitors gaining access to the same intellectual
property. Ultimately, we could be prevented from commercializing a product, or be forced to cease
some aspect of our business operations, if, as a result of actual or threatened patent infringement
claims, we or our collaborators are unable to enter into licenses on acceptable terms. This could
harm our business significantly.
There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries. In addition to
infringement claims against us, we may become a party to other patent litigation and other
proceedings, including interference proceedings declared by the United States Patent and Trademark
Office and opposition proceedings in the European Patent Office, regarding intellectual property
rights with respect to our products and technology. The cost to us of any patent litigation or
other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may
be able to sustain the costs of such litigation or proceedings more effectively than we can because
of their substantially greater financial resources. Uncertainties resulting from the initiation
and continuation of patent litigation or other proceedings could have a material adverse effect on
our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb
significant management time.
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If we fail to comply with our obligations in our intellectual property licenses with third
parties, we could lose license rights that are important to our business.
Our commercial success will also depend on our ability to develop, manufacture, use,
sell and offer to sell our product candidates and proposed product candidates without breaching our
agreements with our patent licensors. We are a party an exclusive license with Emory, covering
aspects of our v-protectant® technology. We expect to enter into additional licenses in the
future. Our exclusive license with Emory requires us to take steps to commercialize the licensed
technology in a timely manner. If we fail to meet these obligations, Emory can convert our
exclusive license to a non-exclusive license, can grant others non-exclusive rights in the licensed
technology or can require us to sublicense aspects of the licensed technology. Our existing
license imposes, and we expect future licenses will impose, various diligence, milestone payments,
royalty, insurance and other obligations on us. If we fail to comply with these obligations, the
licensor may have the right to terminate the license, in which event we might not be able to market
any product that is covered by the licensed patents.
If we are unable to protect the confidentiality of our proprietary information and know-how, the
value of our technology and products could be adversely affected.
In addition to patented technology, we rely on trade secrets, proprietary know-how and
technological advances, which we seek to protect through agreements with our collaborators,
employees and consultants. These persons and entities could breach our agreements, for which
breaches we may not have adequate remedies. In addition, others could become aware of our trade
secrets or proprietary know-how through independent discovery or otherwise. If we are unable to
protect the confidentiality of our proprietary information and know-how, competitors may be able to
use this information to develop products that compete with our products, which could adversely
impact our business.
Risks Related to Regulatory Approval of Our Product Candidates
Because we cannot predict whether or when we will obtain regulatory approval to commercialize
our product candidates, we cannot predict the timing of any future revenue from these product
candidates.
We cannot commercialize any of our product candidates, including AGI-1067 and AGI-1096,
until the appropriate regulatory authorities have reviewed and approved the applications for the
product candidates. The regulatory agencies may not complete their review processes in a timely
manner and we may not obtain regulatory approval for any product candidate we or our collaborators
develop. Satisfaction of regulatory requirements typically takes many years, if approval is
obtained at all, is dependent upon the type, complexity and novelty of the product and requires the
expenditure of substantial resources. Regulatory approval processes outside the United States
include all of the risks associated with the FDA approval process. In addition, we may experience
delays or rejections based upon additional government regulation from future legislation or
administrative action or changes in FDA policy during the period of product development, clinical
trials and FDA regulatory review. The FDA has substantial discretion in the approval process and
may refuse to accept any application or may decide that our data is insufficient for approval and
require additional preclinical, clinical or other studies. In addition, varying interpretations of
the data obtained from preclinical and clinical testing could delay, limit or prevent regulatory
approval of a product candidate.
We may experience delays in our clinical trials that could adversely affect our financial
results and our commercial prospects.
We do not know whether planned clinical trials will begin on time or whether we will
complete any of our clinical trials on schedule or at all. Product development costs to us and our
collaborators will increase if we have delays in testing or approvals or if we need to perform more
or larger clinical trials than planned. Significant delays may adversely affect our financial
results and the commercial prospects for our products, and delay our ability to become profitable.
We rely heavily on independent clinical investigators, contract research organizations
and other third party service providers for successful execution of our clinical trials, but do not
control many aspects of their activities. We are responsible for ensuring that each of our
clinical trials is conducted in accordance with the general investigational plan and protocols for
the trial. Moreover, the FDA requires us to comply with standards, commonly referred to as Good
Clinical Practices, for conducting and recording and reporting the results of clinical trials to
assure that data and reported results are credible and accurate and that the rights, integrity and
confidentiality of trial participants are protected. Our reliance on third parties that we do not
control does not relieve us of these
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responsibilities and requirements. Third parties may not complete activities on schedule, or may
not conduct our clinical trials in accordance with regulatory requirements or our stated protocols.
The failure of these third parties to carry out their obligations could delay or prevent the
development, approval and commercialization of our product candidates.
Failure to obtain regulatory approval in international jurisdictions would prevent us from
marketing our products abroad.
We intend to have our products marketed outside the United States. In order to market
our products in the European Union and many other foreign jurisdictions, we must obtain separate
regulatory approvals and comply with numerous and varying regulatory requirements. The approval
procedure varies among countries and can involve additional testing. The time required to obtain
approval may differ from that required to obtain FDA approval. The foreign regulatory approval
process may include all of the risks associated with obtaining FDA approval. We may not obtain
foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure
approval by regulatory authorities in other countries or jurisdictions, and approval by one foreign
regulatory authority does not ensure approval by regulatory authorities in other foreign countries
or jurisdictions or by the FDA. We and any future collaborators may not be able to file for
regulatory approvals and may not receive necessary approvals to commercialize our products in any
market.
If we do not comply with applicable regulatory requirements in the manufacture and distribution
of our products, we may incur penalties that may inhibit our ability to commercialize our
products and adversely affect our revenue.
Our failure to comply with applicable FDA or other regulatory requirements, including
manufacturing, quality control, labeling, safety surveillance, promoting and reporting, may result
in criminal prosecution, civil penalties, recall or seizure of our products, total or partial
suspension of production or an injunction, as well as other regulatory action against our potential
products or us. Discovery of previously unknown problems with a product, supplier, manufacturer or
facility may result in restrictions on the sale of our products, including a withdrawal of such
products from the market.
Even if the FDA approves our product candidates, the approval will be limited to those
indications and conditions for which we are able to show clinical safety and efficacy.
Any regulatory approval that we may receive for our current or future product candidates
will be limited to those diseases and indications for which these product candidates are clinically
demonstrated to be safe and effective. In addition to the FDA approval required for new
formulations, any new indication to an approved product also requires FDA approval. If we are not
able to obtain FDA approval for a broad range of indications for our product candidates, our
ability to effectively market and sell our product candidates may be greatly reduced and our
business will be adversely affected.
Risks Related to Our Operations
Our failure to attract, retain and motivate skilled personnel and cultivate key academic
collaborations could materially adversely affect our research and development efforts.
We are a small company with approximately 57 full-time employees. If we are unable to
continue to attract, retain and motivate highly qualified management and scientific personnel and
to develop and maintain important relationships with leading academic institutions and scientists,
we may not be able to achieve our research and development objectives. Competition for personnel
and academic collaborations is intense. We have entered into employment agreements with each of
our executive officers. These employment agreements are terminable by the employee on short
notice. Loss of the services of any of these officers or of our key scientific personnel could
adversely affect the progress of our research and development programs. All of our other employees
are at will employees. We do not carry key person insurance on any employee.
Our activities involve the use of hazardous materials, which subject us to regulation, related
costs and delays and potential liabilities.
Our research and development involves the controlled use of hazardous materials, chemicals and
various radioactive compounds. Although we believe that our safety procedures for handling and
disposing of these materials comply with the standards prescribed by state and federal regulations,
the risk of accidental contamination or injury from these materials cannot be eliminated. If an
accident
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occurs, we could be held liable for resulting damages, which could be substantial. We are
also subject to numerous environmental, health and workplace safety laws and regulations, including
those governing laboratory procedures, exposure to blood-borne pathogens and the handling of
biohazardous materials. Additional federal, state and local laws and regulations affecting our
operations may be adopted in the future. We may incur substantial costs to comply with, and
substantial fines or penalties if we violate, any of these laws or regulations.
Risks Related to our Common Stock and Indebtedness
Our stock price has been and may continue to be volatile.
The market price of our common stock, and the market prices for securities of pharmaceutical
and biotechnology companies in general, have been highly volatile and may continue to be highly
volatile in the future. During the period from January 1, 2007 to February 25, 2008, the
closing sale price of our common stock on the Nasdaq Global Market ranged from a low of $0.36 per
share to a high of $12.46 per share. The following factors, in addition to other risk factors
described in this report, may have a significant impact on the market price of our common stock:
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results of clinical trials of our product candidates, particularly AGI-1067, and those
of our competitors; |
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our possible delisting from the Nasdaq Global Market; |
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developments concerning any research and development, manufacturing and marketing
collaborations, including whether and when we achieve milestones; |
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announcements of technological innovations or new commercial products by our
competitors or us; |
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developments concerning proprietary rights, including patents; |
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the addition or termination of research programs or funding support; |
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publicity regarding actual or potential results relating to medicinal products under
development by our competitors or us; |
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regulatory developments in the United States and other countries; |
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litigation; |
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economic and other external factors, including disasters or crises; |
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our possible filing under the Bankruptcy Code; |
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period-to-period fluctuations in financial results; and |
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analysts recommendations. |
In the past, following periods of volatility in the market price of a companys securities,
securities class action litigation has often been instituted. Similar lawsuits may be filed
against us and our executive officers and directors. Litigation can be costly, time consuming and
disruptive to normal business operations. The defense of these lawsuits could also result in
diversion of our managements time and attention away from business operations, which could harm
our business.
Conversion of our convertible notes will dilute the ownership interest of existing shareholders
and could adversely affect the market price of our common stock.
The conversion of some or all of the 1.5% Convertible Notes due 2012, the 4.5% Convertible
Notes due 2011 or the 4.5% Convertible Notes due 2008 will dilute the ownership interests of
existing shareholders. We have in the past, and may in the future, issue additional convertible
notes that would be dilutive. Any sales in the public market of the common stock issuable upon
such conversion could adversely affect prevailing market prices of our common stock. In addition,
the existence of the notes may encourage short selling by market participants because the
conversion of the notes could depress the price of our common stock.
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Our shareholder rights plan and anti-takeover provisions in our charter documents may make an
acquisition of us, which may benefit our shareholders, more difficult.
Our shareholder rights plan and provisions of our articles of incorporation and bylaws could
make it more difficult for a third party to acquire us. These documents include provisions that:
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allow our shareholders the right to acquire common stock from us at discounted prices
in the event a person acquires 15% or more of our common stock or announces an attempt to
do so without our board of directors prior consent; |
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authorize the issuance of blank check preferred stock by our board of directors
without shareholder approval, which would increase the number of outstanding shares and
could thwart a takeover attempt; |
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limit who may call a special meeting of shareholders; |
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require shareholder action without a meeting by unanimous written consent; |
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establish advance notice requirements for nominations for election to the board of
directors or for proposing matters that can be acted upon at shareholder meetings; |
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establish a staggered board of directors whose members can only be dismissed for cause; |
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adopt the fair price requirements and rules regarding business combinations with
interested shareholders set forth in Article 11, Parts 2 and 3 of the Georgia Business
Corporation Code; and |
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require approval by the holders of at least 75% of the outstanding common stock to amend any
of the foregoing provisions. |
Item 1B. Unresolved SEC Staff Comments
None.
Item 2. Properties
Our scientific and administration facility encompasses approximately 50,000 square feet in
Alpharetta, Georgia. We lease our facility pursuant to a long-term lease agreement that expires in
2009, and our remaining aggregate commitment under this long-term, non-cancelable lease is
approximately $1.4 million. This lease may be extended at our option to 2019.
In November 2001, we leased a facility in Norcross, Georgia encompassing approximately 5,800
square feet. We leased this laboratory facility pursuant to a long-term lease agreement that, as
amended, expired in 2007. As part of our strategic plan in May 2007, the facility in Norcross was
closed and the lease was not renewed.
Item 3. Legal Proceedings
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
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PART II
Item 5. Market for Registrants Common Equity, Related Shareholder Matters and Issuer Purchases of
Equity Securities
Common Stock Information
Our common stock is traded on the Nasdaq Global Market under the symbol AGIX. The following
table sets forth the range of high and low reported last sale price per share of our common stock
as quoted on the Nasdaq Global Market for each period indicated.
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Common Stock |
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High |
|
Low |
Year ended December 31, 2007 |
|
|
|
|
|
|
|
|
First quarter |
|
$ |
12.46 |
|
|
$ |
2.80 |
|
Second quarter |
|
|
3.86 |
|
|
|
2.10 |
|
Third quarter |
|
|
3.00 |
|
|
|
1.12 |
|
Fourth quarter |
|
|
1.86 |
|
|
|
0.36 |
|
Year ended December 31, 2006 |
|
|
|
|
|
|
|
|
First quarter |
|
$ |
20.67 |
|
|
$ |
15.00 |
|
Second quarter |
|
|
16.18 |
|
|
|
12.53 |
|
Third quarter |
|
|
14.17 |
|
|
|
12.23 |
|
Fourth quarter |
|
|
15.21 |
|
|
|
9.91 |
|
As of February 25, 2008, there were approximately 13,700 holders of our common stock. This number
includes beneficial owners of our common stock whose shares are held in the names of various
dealers, clearing agencies, banks, brokers and other fiduciaries.
Dividend Policy
We have never declared or paid any dividends on our capital stock. We currently intend to
retain all of our future earnings, if any, to finance our operations and do not anticipate paying
any cash dividends on our capital stock in the foreseeable future.
Securities Authorized for Issuance Under Equity Compensation Plans
We have set forth information relating to securities authorized for issuance under equity
compensation plans under the caption Equity Compensation Plan Information in our proxy statement
for our 2008 annual meeting of shareholders to be held on May 22, 2008. We are incorporating this
information by reference into this Form 10-K.
24
Item 6. Selected Financial Data
The selected financial data set forth below should be read in conjunction with our financial
statements and the related notes and Managements Discussion and Analysis of Financial Condition
and Results of Operations, included in this annual report. The historical results are not
necessarily indicative of the operating results to be expected in the future.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License fees |
|
$ |
27,083,333 |
|
|
$ |
22,916,667 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Research and development |
|
|
25,193,494 |
|
|
|
8,758,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
52,276,827 |
|
|
|
31,674,845 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
72,696,066 |
|
|
|
82,855,340 |
|
|
|
71,278,945 |
|
|
|
59,235,833 |
|
|
|
46,660,960 |
|
Marketing, general and administrative |
|
|
13,936,132 |
|
|
|
13,373,112 |
|
|
|
9,050,290 |
|
|
|
6,607,506 |
|
|
|
5,930,675 |
|
Restructuring and impairment costs |
|
|
9,996,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
96,628,530 |
|
|
|
96,228,452 |
|
|
|
80,329,235 |
|
|
|
65,843,339 |
|
|
|
52,591,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(44,351,703 |
) |
|
|
(64,553,607 |
) |
|
|
(80,329,235 |
) |
|
|
(65,843,339 |
) |
|
|
(52,591,635 |
) |
Interest and other income |
|
|
6,007,678 |
|
|
|
9,175,817 |
|
|
|
6,691,965 |
|
|
|
1,447,001 |
|
|
|
1,258,216 |
|
Interest expense |
|
|
(11,124,544 |
) |
|
|
(8,423,346 |
) |
|
|
(8,917,057 |
) |
|
|
(5,192,894 |
) |
|
|
(1,954,402 |
) |
Other expense |
|
|
|
|
|
|
(3,521,236 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(49,468,569 |
) |
|
$ |
(67,322,372 |
) |
|
$ |
(82,554,327 |
) |
|
$ |
(69,589,232 |
) |
|
$ |
(53,287,821 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(1.25 |
) |
|
$ |
(1.71 |
) |
|
$ |
(2.19 |
) |
|
$ |
(1.88 |
) |
|
$ |
(1.49 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and
diluted net loss per share |
|
|
39,500,154 |
|
|
|
39,383,376 |
|
|
|
37,774,203 |
|
|
|
37,070,235 |
|
|
|
35,770,994 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table contains a summary of our balance sheet data as of December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
2005 |
|
2004 |
|
2003 |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments |
|
$ |
92,875,420 |
|
|
$ |
151,810,939 |
|
|
$ |
182,504,523 |
|
|
$ |
66,924,015 |
|
|
$ |
131,583,928 |
|
Working capital |
|
|
50,229,551 |
|
|
|
118,786,367 |
|
|
|
173,164,668 |
|
|
|
59,719,811 |
|
|
|
124,848,687 |
|
Total assets |
|
|
103,139,028 |
|
|
|
178,339,664 |
|
|
|
197,497,527 |
|
|
|
74,462,327 |
|
|
|
138,836,746 |
|
Current portion of long-term debt |
|
|
35,968,750 |
|
|
|
|
|
|
|
33,784 |
|
|
|
83,622 |
|
|
|
479,439 |
|
Long-term debt |
|
|
252,163,102 |
|
|
|
286,000,000 |
|
|
|
300,053,796 |
|
|
|
100,000,000 |
|
|
|
100,083,622 |
|
Accumulated deficit |
|
|
(411,465,815 |
) |
|
|
(361,997,246 |
) |
|
|
(294,674,874 |
) |
|
|
(212,120,547 |
) |
|
|
(142,531,315 |
) |
Total shareholders (deficit) equity |
|
|
(195,594,625 |
) |
|
|
(153,987,649 |
) |
|
|
(115,436,216 |
) |
|
|
(35,942,382 |
) |
|
|
30,377,006 |
|
25
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion should be read in conjunction with our financial statements and
related notes included in this annual report. In this report, AtheroGenics, we, us and our
refer to AtheroGenics, Inc.
This annual report contains forward-looking statements made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject
to certain factors, risks and uncertainties that may cause actual results, events and performances
to differ materially from those referred to in such statements. These risks include statements
which address operating performance, events or developments that we expect or anticipate will occur
in the future, such as projections about our future results of operations or financial condition,
research, development and commercialization of our product candidates, expectations regarding the
completion of our clinical trials and the related release of results, anticipated trends in our
business, and other risks that could cause actual results to differ materially. You should
carefully consider these risks, which are discussed in this annual report, including, without
limitation, in the sections entitled Risk Factors and Managements Discussion and Analysis of
Financial Condition and Results of Operations, and in AtheroGenics SEC filings.
Overview
AtheroGenics is a research-based pharmaceutical company focused on the discovery, development
and commercialization of novel drugs for the treatment of chronic inflammatory diseases, including
diabetes and coronary heart disease. We currently have one late stage clinical drug development
program.
AGI-1067 is our investigational drug with demonstrated anti-inflammatory and antioxidant
properties that is being studied to determine its ability to improve
blood sugar control (glycemic
control) in patients with diabetes and potentially reduce clinical events in patients with
cardiovascular disease.
In 2003, we initiated a Phase III trial, referred to as ARISE (Aggressive Reduction of
Inflammation Stops Events), which evaluated the impact of AGI-1067 on a composite measure of heart
disease outcomes, including death due to coronary disease, myocardial infarction (heart attack),
stroke, coronary re-vascularization and unstable angina. Important measures of glycemic control
were included for patients with diabetes who also had coronary heart disease. The study assessed
the incremental benefits of AGI-1067 versus the current standard of care therapies in this patient
population. As such, all patients in the trial, including those on placebo, received other
appropriate heart disease and diabetes medications, including statins and other
cholesterol-lowering therapies, and glycemic control agents.
The ARISE trial results were reported in March 2007 and demonstrated that while AGI-1067 did
not show a difference from placebo in the composite primary endpoint, the study did achieve a
number of other important predefined endpoints. These endpoints included a reduction in the
composite of hard atherosclerotic clinical endpoints, composed of cardiovascular death,
resuscitated cardiac arrest, myocardial infarction and stroke.
AGI-1067 achieved a significant reduction of 19% in the rate of these
combined hard endpoints. There were also improvements in the
key diabetes parameters of new-onset diabetes and glycemic control. Based on our review of the
ARISE results, we are pursuing continued development of the compound, initially as a diabetes
medication. We expect that two positive registration studies in patients with diabetes will be
required to submit a New Drug Application (NDA) for marketing approval.
In August 2007, we commenced the first registration study for diabetes called ANDES (AGI-1067
as Novel Anti-Diabetic Agent Evaluation Study), a multi-center, double-blind study with 6-month
dosing using three doses, designed to compare the effects of AGI-1067 versus placebo on glycemic
endpoints in subjects with confirmed type 2 diabetes. Patient enrollment for
ANDES was completed in December 2007. Dosing is expected to be completed in June 2008. The study
protocol provides for an interim analysis which we expect to occur in the second quarter of 2008.
Further development activity, including design of the second registration study, will be determined
after reviewing the results of ANDES and conducting discussions with the FDA.
In 2005, we entered into a license and collaboration agreement with AstraZeneca for the global
development and commercialization of AGI-1067. Under the terms of the agreement, we received a
license fee of $50 million. In April 2007, AstraZeneca notified us that pursuant to the terms of
the agreement, it was ending the collaboration. The agreement was terminated in July 2007.
In the second half of 2006, we were engaged by AstraZeneca to conduct FOCUS (Follow-up Of
Clinical Outcomes: The Long-term AGI-1067 plus Usual Care Study). FOCUS is a follow-up Phase III
clinical trial for patients exiting ARISE, designed to collect
26
extended safety information. Pursuant to the terms of our license agreement, AstraZeneca
funded the entire cost of the trial, which has been concluded.
AGI-1096, our second v-protectant® candidate, is a novel antioxidant and selective
anti-inflammatory agent to address the accelerated inflammation of grafted blood vessels, known as
transplant arteritis, common in chronic organ transplant rejection. We worked with Astellas Pharma
Inc. (Astellas) to further develop AGI-1096, with Astellas funding the costs for development
activities under the agreement. Astellas has informed us that they have completed their current
development activities and do not have further development plans. We are not currently undertaking
any development activities on AGI-1096.
The following table provides information regarding our research and development expenses for
our major product candidates:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
Direct external AGI-1067 costs |
|
$ |
47,149,947 |
|
|
$ |
53,136,660 |
|
|
$ |
51,087,586 |
|
Unallocated costs and other programs |
|
|
25,546,119 |
|
|
|
29,718,680 |
|
|
|
20,191,359 |
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
72,696,066 |
|
|
$ |
82,855,340 |
|
|
$ |
71,278,945 |
|
|
|
|
|
|
|
|
|
|
|
From inception, we have devoted the large majority of our research and development efforts and
financial resources to support development of the AGI-1067 product candidate. Spending for the
AGI-1096 program in 2007, 2006 and 2005 was funded by our collaborative development partner,
Astellas.
Based on the results of the ARISE clinical trial, AtheroGenics has developed a new business
plan to streamline operations and focus on development of AGI-1067. In May 2007, as part of the
strategic plan AtheroGenics implemented the following:
|
|
|
announced the focus on diabetes as the next step in the development of AGI-1067 and
commenced a new Phase III clinical trial, called ANDES, studying the effect of AGI-1067 in
patients with diabetes; |
|
|
|
|
reduced AtheroGenics near term cash requirements by exchanging $38.0 million of the
4.5% convertible notes due September 2008 for $60.4 million of 4.5% convertible notes that
will be due in March 2011; |
|
|
|
|
reduced the workforce by approximately 50%, resulting in a staff of 67 employees at that
date; and |
|
|
|
|
implemented a retention/incentive program for key executive officers and employees. |
The nature, timing and costs of the efforts to complete the successful development of any of
our product candidates are highly uncertain and subject to numerous risks, and therefore cannot be
accurately estimated. These risks include the rate of progress and costs of our clinical trials,
clinical trial results, cost and timing of regulatory approval and establishing commercial
manufacturing supplies. These risks and uncertainties, and their effect on our operations and
financial position, are more fully described above in our risk factors under the headings Risks
Related to Development and Commercialization of Product Candidates and Dependence on Third Parties
and Risks Related to Regulatory Approval of Our Product Candidates.
We have not derived any commercial revenues from product sales. We expect to incur
significant losses in most years prior to deriving any such product revenue as we continue our
research and development activities. We have funded our operations primarily through sales of
equity and debt securities. We have incurred significant losses since we began operations and, as
of December 31, 2007, had an accumulated deficit of $411.5 million. We cannot assure you that we
will become profitable. We expect that losses will fluctuate from quarter to quarter and that
these fluctuations may be substantial. Our ability to achieve profitability depends upon our
ability, alone or with others, to complete the successful development of our product candidates, to
obtain required regulatory clearances and to manufacture and market our future products.
Critical Accounting Policies and Use of Estimates
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions and select accounting policies
that affect the amounts reported in our financial statements and the accompanying notes. Actual
results could significantly differ from those estimates. We have identified the following policies
and related estimates as critical to our business operations and the understanding of our results
of operations. A description of these critical
27
accounting policies and a discussion of the significant estimates and judgments associated with
these policies are set forth below. The impact of and any associated risks related to these
policies on our business operations are also discussed throughout Managements Discussion and
Analysis of Financial Condition and Results of Operations.
Research and Development Accrual
As part of the process of preparing our financial statements, we are required to estimate
expenses that we believe we have incurred, but have not yet been billed for. This process involves
identifying services and activities that have been performed by third party vendors on our behalf
and estimating the level to which they have been performed and the associated cost incurred for
such service as of each balance sheet date in our financial statements. Examples of expenses for
which we accrue include fees for professional services, such as those provided by certain clinical
research organizations and investigators in conjunction with clinical trials, and fees owed to
contract manufacturers in conjunction with the manufacture of clinical trial materials. We make
these estimates based upon progress of activities related to contractual obligations and also
information received from vendors.
Revenue Recognition
We recognize license fee revenues in accordance with the SECs Staff Accounting Bulletin
(SAB) No. 101, Revenue Recognition in Financial Statements, as amended by SAB No. 104, Revenue
Recognition, (SAB 104). SAB 104 provides guidance in applying U.S. generally accepted accounting
principles to revenue recognition issues, and specifically addresses revenue recognition for
upfront, nonrefundable fees received in connection with research collaboration agreements.
In accordance with SAB 104, license fees, which are nonrefundable, are recognized over the
period the related license agreements specify that efforts or obligations are required of us. In
February 2006, we received a $50 million license fee in connection with our license and
collaboration agreement with AstraZeneca. The upfront nonrefundable license payment was being
recognized on a straight-line basis over the 24-month period that we estimated we were obligated to
provide services to the licensee. In April 2007, AstraZeneca announced that it was ending the
license and collaboration agreements and any further obligations required of us. As such, the
remaining balance of approximately $20.8 million in deferred revenue related to the license fee was
recognized as revenue in the second quarter of 2007.
During the third quarter of 2006, AstraZeneca separately engaged us to perform FOCUS, a
follow-up Phase III clinical trial for patients who have completed ARISE. Revenues under the research and development agreement pertaining to
FOCUS are recognized in accordance with Emerging Issues Task Force (EITF) Issue No. 99-19,
Reporting Gross Revenue as a Principal vs. Net as an Agent. According to the criteria established
by EITF Issue No. 99-19, we are the primary obligor of the agreement because we are responsible for
the selection, negotiation, contracting and payment of the third party suppliers. In addition, any
liabilities resulting from the agreement are the responsibility of AtheroGenics. Research and
development revenues are recognized, on a gross basis, as activities are performed under the terms
of the related agreement. AtheroGenics concluded FOCUS in 2007, and closing activities were billed to
AstraZeneca in accordance with the agreement.
Stock-Based Compensation
Effective January 1, 2006, we adopted the provisions of Statement of Financial Accounting
Standards (SFAS) SFAS No. 123(R), Share-Based Payment (SFAS 123(R)), which revises SFAS No.
123, Accounting for Stock-Based Compensation and supersedes Accounting Principles Board Opinion No.
25, Accounting for Stock Issued to Employees. SFAS 123(R) requires that companies recognize
compensation expense associated with stock option grants and other equity instruments to employees
in the financial statements. That expense is recognized in the statement of operations over the
period during which an employee is required to provide service in exchange for the reward.
Stock-based compensation expense is recorded in research and development expense or marketing,
general and administrative expense depending on the employees job function. SFAS 123(R) applies
to all grants after the effective date and to the unvested portion of stock options outstanding as
of the effective date. The pro forma disclosures previously permitted under SFAS 123 are no longer
an alternative to financial statement recognition. We are using the modified-prospective method
and the Black-Scholes valuation model for valuing the share-based payments. We will continue to
account for transactions in which services are received in exchange for equity instruments based on
the fair value of such services received from non-employees, in accordance with SFAS 123 and
EITF Issue No. 96-18, Accounting for Equity Instruments that Are Issued to Other than Employees for
Acquiring, or in Conjunction with Selling, Goods or Services.
28
Results of Operations
Comparison of Years Ended December 31, 2007 and 2006
Revenues
Total revenues were $52.3 million and $31.7 million for the year ended December 31, 2007 and
2006, respectively. The increase in license revenues to $27.1 million for the year ended 2007 from
$22.9 million for the same period in 2006, reflects the recognition of the unamortized balance of
the upfront license fee from AstraZeneca, due to the termination of the agreement in April 2007.
Research and development revenues increased to $25.2 million for the year 2007 from $8.8 million
for the comparable period in 2006. The revenues in both periods are for services performed for
AstraZeneca related to the FOCUS clinical trial, which began in August 2006. Due to the results of
the ARISE clinical trial, AtheroGenics concluded the FOCUS clinical trial. No further research and
development revenues related to the FOCUS clinical trial are expected to be recorded.
Expenses
Research and Development. Research and development expenses were $72.7 million for the year
ended December 31, 2007, compared to $82.9 million for the same period in 2006. The decrease of
$10.2 million, or 12%, is primarily due to lower expenditures associated with the completion of the
ARISE clinical trial and reduced staff costs resulting from our organizational restructuring in May
2007. This decrease is partially offset by the start up of the ANDES clinical trial, which include
activities for clinical drug supply, data management, study monitoring and payments to clinical
investigators, and higher FOCUS expenses.
We expect that research and development expenses in 2008 will be less than the level incurred
in 2007. These expenses will be primarily related to activities surrounding the ANDES clinical
trial in a range of $15.0 million to $20.0 million, and other programs associated with the
development of AGI-1067.
Marketing, General and Administrative. Marketing, general and administrative expenses were
$13.9 million for the year ended December 31, 2007, compared to $13.4 million for the same period
in 2006. The increase of $563,000, or 4%, is primarily due to higher marketing-related costs in
the first half of 2007.
Restructuring and Impairment Costs. AtheroGenics implemented a new business plan that
involved streamlining company operations and focusing on the development of AGI-1067 in diabetes.
In connection with the new business plan, restructuring and impairment costs of $10.0 million were
incurred in June 2007. We recorded non-cash impairments for asset write-downs of $9.0 million of
which $7.5 million was a result of the termination of the collaboration and transition of
commercial manufacturing activities from AstraZeneca. Other restructuring and impairment costs
include severance of approximately $1.0 million associated with the reduction in workforce and
asset impairment costs of approximately $1.5 million for certain excess laboratory equipment and
leasehold improvements.
Interest and Other Income
Interest and other income is primarily comprised of interest income earned on our cash and
short-term investments. Interest and other income was $6.0 million for the year ended December 31,
2007, compared to $9.2 million for the same period in 2006. The decrease was a result of the lower
balance of cash and short-term investment funds in 2007 than in the comparable period in 2006.
Interest Expense
Interest expense was $11.1 million for the year ended December 31, 2007 compared to $8.4
million for the same period in 2006. The increase in interest expense is due to accretion of the
discount of $2.1 million related to the $38.0 million of the 4.5% convertible notes due 2008 that
were exchanged for $60.4 million of the 4.5% convertible notes due 2011, as well as the additional
interest for the newly issued notes and the write-off of debt issuance costs related to the
extinguished notes.
Other Expense
Other expense was $3.5 million for the year ended December 31, 2006 is due to non-cash expense
related to the exchange of $14.0 million of our 4.5% convertible notes for common stock in the
first quarter of 2006. There was no other expense in 2007.
29
Income Taxes
As of December 31, 2007, we had net operating loss carryforwards and research and development
credit carryforwards of $387.8 million and $13.6 million, respectively, available to offset future
taxable income. The net operating loss carryforwards and the research and development credit
carryforwards will expire between 2010 and 2028. Because of our lack of earnings history, the
resulting deferred tax assets have been fully offset by a valuation allowance. The utilization of
the carryforwards is dependent upon the timing and extent of our future profitability. The annual
limitations combined with the expiration dates of the carryforwards may prevent the utilization of
all of the net operating loss and research and development credit carryforwards if we do not attain
sufficient profitability by the expiration dates of the carryforwards.
Comparison of Years Ended December 31, 2006 and 2005
Revenues
Total revenues were $31.7 million for the year ended December 31, 2006. The license fee
revenues of $22.9 million are attributable to the license and collaboration agreement, effective
January 2006, with AstraZeneca for the development and commercialization of AGI-1067. This amount
represents the earned portion of the $50.0 million nonrefundable license fee that is being
amortized over 24 months. The research and development revenues of $8.8 million were for services
performed for AstraZeneca related to the FOCUS clinical trial. There were no revenues during 2005.
Expenses
Research and Development. Research and development expenses were $82.9 million for the year
ended December 31, 2006, compared to $71.3 million for the same period in 2005. The increase of
$11.6 million, or 16%, was primarily due to expenditures associated with the ARISE clinical trial
and the start up of the FOCUS clinical trial, which include activities for clinical drug supply,
data management, study monitoring and payments to clinical investigators, and preparation for a New
Drug Application filing. Also contributing to the increase was the non- cash stock-based
compensation of $4.9 million, resulting from the adoption of SFAS 123(R) in January 2006.
Marketing, General and Administrative. Marketing, general and administrative expenses were
$13.4 million for the year ended December 31, 2006, compared to $9.1 million for the same period in
2005. The increase of $4.3 million, or 48%, is primarily due to the non-cash stock-based
compensation of $4.4 million, resulting from the adoption of SFAS123(R) in January 2006 partially
offset by lower professional fees associated with the license and collaboration agreement incurred
in 2005.
Interest and Other Income
Interest and other income is primarily comprised of interest income earned on our cash and
short-term investments. Interest and other income was $9.2 million for the year ended December 31,
2006, compared to $6.7 million for the same period in 2005. The increase was primarily a result of
higher interest rates on our investments.
Interest Expense
Interest expense was $8.4 million for the year ended December 31, 2006 compared to $8.9
million for the same period in 2005. The decrease in interest expense is due to the lower
aggregate principal amount of our 4.5% convertible notes outstanding compared to prior year. Our
outstanding debt balance was reduced by $14.0 million in January 2006 when certain note holders
elected to convert their holdings into shares of our common stock.
Other Expense
Other expense was $3.5 million for the year ended December 31, 2006. The increase in other
expense is due to $3.5 million of non-cash expense related to the exchange of $14.0 million of our
4.5% convertible notes for common stock in the first quarter of 2006.
There was no other expense in 2005.
30
Income Taxes
As of December 31, 2006, we had net operating loss carryforwards and research and development
credit carryforwards of $331.9 million and $12.0 million, respectively, available to offset future
taxable income.
Liquidity and Capital Resources
Since inception, we have financed our operations primarily through sales of equity securities
and convertible notes. At December 31, 2007, we had cash, cash equivalents and short-term
investments of $92.9 million, compared with $151.8 million and $182.5 million at December 31, 2006
and 2005, respectively. Working capital at December 31, 2007 was $50.2 million, compared to $118.8
million and $173.2 million at December 31, 2006 and 2005, respectively. The decrease in cash, cash
equivalents, short-term investments and working capital in 2007 and 2006 is primarily due to the
use of funds for operating purposes. The increase in cash, cash equivalents and short-term
investments and working capital in 2005 is due to funds received from the issuance of our 1.5%
convertible notes in January 2005 that raised net proceeds of approximately $193.6 million.
Net cash used in operating activities was $56.4 million in 2007 compared to $27.0 million in
2006 and $77.8 million in 2005. The use of cash in operating activities in 2007 is primarily
attributable to funding a net loss of $49.5 million that included expenditures for the close-out of
our ARISE and FOCUS Phase III clinical trials for AGI-1067, the start-up of our ANDES Phase III
clinical trial for AGI-1067, as well as other ongoing product development activities. The use of
cash in operating activities in 2006 is primarily attributable to funding a net loss of $67.3
million, partially offset by the $50.0 million license fee received from AstraZeneca. For 2008,
cash expenditures for the ANDES clinical trial are estimated to be in the range of $15.0 million
to $20.0 million.
Net cash provided by investing activities was $43.3 million in 2007 compared to $30.4 million
in 2006 and $51.7 million used in investing activities in 2005. Net cash provided by investing
activities in 2007 consisted primarily of net sales of available-for-sale securities, partially
offset by $2.6 million to purchase equipment and leasehold improvements. Net cash provided by
investing activities in 2006 consisted primarily of net sales of available-for-sale securities.
This was partially offset by $5.5 million to purchase equipment and leasehold improvements, which
included $3.5 million for commercial manufacturing equipment. Net cash used in investing
activities in 2005 consisted primarily of net purchases of available-for-sale securities.
Additionally, in 2005, $3.0 million was used to purchase equipment and leasehold improvements,
which included $1.9 million spent for commercial manufacturing equipment.
Net cash provided by financing activities was $23,075 in 2007 compared to $1.7 million in 2006
and $196.5 million in 2005. Net cash provided by financing activities in 2007 and 2006 consisted
of primarily of proceeds received upon exercise of common stock options. Net cash provided by
financing activities in 2005 consisted primarily of $193.6 million received from the issuance of
1.5% convertible notes in January 2005.
In August 2003, we issued $100 million in aggregate principal amount of 4.5% convertible notes
due 2008 (the 2008 Notes) through a Rule 144A private placement to qualified institutional
buyers. These notes initially are convertible into our common stock at a conversion rate of
65.1890 shares per $1,000 principal amount of notes, or approximately $15.34 per share. Net
proceeds were approximately $96.7 million. Interest on the 4.5% convertible notes is payable
semi-annually in arrears on March 1 and September 1. In January 2006, we exchanged $14.0 million
in aggregate principal amount of the 4.5% convertible notes for 1,085,000 shares of our common
stock. In July 2007, we extinguished $38.0 million of the 2008 Notes and, and in exchange, issued
$60.4 million of 4.5% convertible notes due 2011 (the 2011 Notes). The 2011 Notes were initially
recorded at their fair value of $38.0 million. The $22.4 million difference between the principal
amount and the initial fair value of the debt, the discount, will be accreted up to the face amount
as additional interest expense over the remaining life of the 2011 Notes. As of December 31, 2007,
we have recorded $1.6 million of accrued interest expense related to the 2008 Notes and the 2011
Notes, which is due March 1, 2008.
In January 2008, we redeemed $17.5 million in aggregate principal amount of our 2008 Notes,
and in exchange issued $11.5 million of 2011 Notes along with $5.5 million of cash. From time to
time, we may enter into additional exchange offers and/or purchases of these notes.
As of February 25, 2008, we had approximately $30.5 million of 2008 Notes outstanding, which
amount will become due on September 1, 2008. Although we expect to have enough cash on hand to
repay all amounts due pursuant to the 2008 Notes and fund 2008 operations, this repayment will
leave substantially less cash to fund ongoing operations during 2009. Our strategy is to raise
additional capital, enter into collaboration arrangements to fund the development and
commercialization of AGI-1067, or restructure our 2008 Notes
31
before they become due. In addition, we received notices from Nasdaq of violations of two
listing standards: (1) failure to maintain a market value of
listed securities above $50 million and (2) failure to maintain a closing bid price of our common stock above $1.00. If our common
stock fails to be listed on the Nasdaq Global Market or another national securities exchange, each
holder of the notes will have the right to require us to redeem the notes at face value. If the
maturity of the outstanding notes were accelerated we would attempt to refinance or restructure
these obligations. If we do not have sufficient liquidity to fund operations or pay any of our
debt when due, we may seek relief under Title 11 of the U.S. Code (the Bankruptcy Code) at some
point in the future.
In January 2005, we issued $200 million in aggregate principal amount of 1.5% convertible
notes due 2012 (the2012 Notes) through a Rule 144A private placement to qualified institutional
buyers. These notes are convertible into shares of our common stock at a conversion rate of
38.5802 shares per $1,000 principal amount of notes, or approximately $25.92 per share. Interest
on the 2012 Notes is payable semi-annually in arrears on February 1 and August 1. Net proceeds
were approximately $193.6 million. As of December 31, 2007, we have recorded $1.3 million of
accrued interest expense related to the notes, which is due February 1, 2008.
The following table summarizes our long-term contractual obligations as of December 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
Total |
|
|
2008 |
|
|
2009-2010 |
|
|
2011-2012 |
|
|
Thereafter |
|
Contractual obligations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating leases |
|
$ |
1,484,114 |
|
|
$ |
1,269,463 |
|
|
$ |
214,651 |
|
|
$ |
|
|
|
$ |
|
|
Long-term debt (1) |
|
|
308,410,000 |
|
|
|
35,968,750 |
|
|
|
|
|
|
|
272,441,250 |
|
|
|
|
|
Interest on long-term debt |
|
|
26,196,435 |
|
|
|
7,607,910 |
|
|
|
12,470,820 |
|
|
|
6,117,705 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
336,090,549 |
|
|
$ |
44,846,123 |
|
|
$ |
12,685,471 |
|
|
$ |
278,558,955 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The long-term debt to be paid in 2011-2012 does not reflect the remaining discount of $20.3
million related to the debt extinguishment in July 2007 discussed above. |
Based upon the current status of our product development and commercialization plans, we
believe that our existing cash, cash equivalents and short-term investments will be adequate to
satisfy our capital needs for at least the next 12 months. However, our actual capital
requirements will depend on many factors, including those factors potentially impacting our
financial condition as discussed in Item 1A. Risk Factors and the following:
|
|
the scope and results of our research, preclinical and clinical development activities; |
|
|
|
the timing of, and the costs involved in, obtaining regulatory approvals; |
|
|
|
the timing, receipt and amount of sales and royalties, if any, from our potential product
candidates; |
|
|
|
our ability to maintain and establish collaborations and the financial terms of any
collaborations; |
|
|
|
the cost of commercialization activities, including product marketing, sales and
distribution; |
|
|
|
the costs involved in preparing, filing, prosecuting, maintaining and enforcing patent
claims and other patent-related costs; and |
|
|
|
the extent to which we acquire or invest in businesses, products and technologies. |
32
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
The primary objective of our investment activities is to preserve principal while at the same
time maximizing the income we receive from our investments without significantly increasing risk.
Some of the securities that we invest in may have market risk. This means that a change in
prevailing interest rates may cause the fair value of the principal amount of the investment to
fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the
then-prevailing rate and the prevailing interest rate later rises, the fair value of the principal
amount of our investment will probably decline. To minimize this risk in the future, we intend to
continue to maintain our portfolio of cash equivalents and short-term investments in a variety of
securities, including commercial paper, all of which have a minimum investment rating of A1/P1,
money market funds, and government and non-government debt securities. The average duration of all
of our investments has generally been less than one year. Due to the short-term nature of these
investments, we believe we have no material exposure to interest rate risk arising from our
investments.
The following table summarizes the maturity of the debt and projected annual weighted average
interest rates on our convertible notes as of December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Value as of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
|
2009-2010 |
|
|
2011-2012 |
|
|
Total |
|
|
2007 |
|
Long-term debt fixed rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturity |
|
$ |
35,968,750 |
|
|
$ |
|
|
|
$ |
272,441,250 |
|
|
$ |
308,410,000 |
|
|
$ |
39,830,450 |
|
Weighted average interest rate |
|
|
4.5 |
% |
|
|
|
|
|
|
2.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The long-term debt to be paid in 2011-2012 does not reflect the remaining discount of $20.3
million related to the debt extinguishment in July 2007 as discussed in Liquidity and Capital
Resources above. |
33
Item 8. Financial Statements and Supplementary Data
ATHEROGENICS, INC.
INDEX TO FINANCIAL STATEMENTS
|
|
|
|
|
Contents |
|
|
|
|
|
|
|
35 |
|
|
|
|
36 |
|
|
|
|
37 |
|
|
|
|
38 |
|
|
|
|
39 |
|
|
|
|
40 |
|
|
|
|
41 |
|
|
|
|
42 |
|
34
MANAGEMENTS ANNUAL REPORT ON
INTERNAL CONTROL OVER FINANCIAL REPORTING
Management of AtheroGenics, Inc. is responsible for establishing and maintaining adequate
internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the
Securities Exchange Act of 1934, as amended. AtheroGenics internal control over financial
reporting is designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with U.S.
generally accepted accounting principles. AtheroGenics internal control over financial reporting
includes those policies and procedures that:
|
|
|
pertain to the maintenance of records that, in reasonable detail, accurately and
fairly reflect the transactions and dispositions of the assets of AtheroGenics; |
|
|
|
|
provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with U.S. generally accepted
accounting principles, and that receipts and expenditures of AtheroGenics are being made
only in accordance with authorizations of management and directors of AtheroGenics; and |
|
|
|
|
provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use or disposition of AtheroGenics assets that could have a material
effect on the financial statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
Management, including AtheroGenics principal executive officer and principal financial
officer, assessed the effectiveness of AtheroGenics internal control over financial reporting as
of December 31, 2007. In making this assessment, management used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal
Control-Integrated Framework.
Based on our assessment and those criteria, management believes that AtheroGenics maintained
effective internal control over financial reporting as of December 31, 2007.
AtheroGenics
independent registered public accounting firm has issued a report
on AtheroGenics internal control over financial reporting which is included herein.
35
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON INTERNAL CONTROL
The Board of Directors and Shareholders of AtheroGenics, Inc.
We have audited AtheroGenics, Inc.s internal control over financial reporting as of December 31,
2007, based on criteria established in Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria).
AtheroGenics, Inc.s management is responsible for maintaining effective internal control over
financial reporting, and for its assessment of the effectiveness of internal control over financial
reporting included in the accompanying Managements Annual Report on Internal Control over
Financial Reporting. Our responsibility is to express an opinion on AtheroGenics, Inc.s internal
control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk,
and performing such other procedures as we considered necessary in the circumstances. We believe
that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles. A
companys internal control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or
detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, AtheroGenics, Inc. maintained, in all material respects, effective internal control
over financial reporting as of December 31, 2007 based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the balance sheets of AtheroGenics, Inc. as of December 31, 2007 and 2006,
and the related statements of operations, shareholders deficit and cash flows for each of the
three years in the period ended December 31, 2007 and our report dated February 29, 2008 expressed
an unqualified opinion thereon.
/s/Ernst & Young LLP
Atlanta, Georgia
February 29, 2008
36
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM ON FINANCIAL STATEMENTS
The Board of Directors and Shareholders of AtheroGenics, Inc.
We have audited the accompanying balance sheets of AtheroGenics, Inc. as of December 31, 2007 and
2006, and the related statements of operations, shareholders deficit and cash flows for each of
the three years in the period ended December 31, 2007. These financial statements are the
responsibility of the Companys management. Our responsibility is to express an opinion on these
financial statements based on our audits.
We conducted our audits in accordance with auditing standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the accounting
principles used and significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable basis for our
opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the financial position of AtheroGenics, Inc. at December 31, 2007 and 2006, and the
results of its operations and its cash flows for each of the three years in the period ended
December 31, 2007, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the effectiveness of AtheroGenics, Inc.s internal control over financial
reporting as of December 31, 2007, based on criteria established in Internal ControlIntegrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our
report dated February 29, 2008 expressed an unqualified opinion thereon.
/s/Ernst & Young LLP
Atlanta, Georgia
February 29, 2008
37
ATHEROGENICS, INC.
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
74,795,388 |
|
|
$ |
87,846,079 |
|
Short-term investments |
|
|
18,080,032 |
|
|
|
63,964,860 |
|
Accounts receivable |
|
|
2,634,422 |
|
|
|
6,537,892 |
|
Prepaid expenses |
|
|
908,379 |
|
|
|
4,038,419 |
|
Interest receivable |
|
|
381,881 |
|
|
|
643,097 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
96,800,102 |
|
|
|
163,030,347 |
|
|
|
|
|
|
|
|
|
|
Equipment and leasehold improvements, net of accumulated depreciation and amortization |
|
|
2,361,053 |
|
|
|
9,684,965 |
|
Debt issuance costs and other assets |
|
|
3,977,873 |
|
|
|
5,624,352 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
103,139,028 |
|
|
$ |
178,339,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders Deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
781,119 |
|
|
$ |
3,183,511 |
|
Accrued research and development |
|
|
3,765,745 |
|
|
|
11,263,164 |
|
Accrued interest |
|
|
2,876,150 |
|
|
|
2,540,000 |
|
Accrued compensation |
|
|
2,258,051 |
|
|
|
1,465,644 |
|
Accrued and other liabilities |
|
|
920,736 |
|
|
|
791,661 |
|
Current portion of convertible notes payable |
|
|
35,968,750 |
|
|
|
|
|
Current portion of deferred revenue |
|
|
|
|
|
|
25,000,000 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
46,570,551 |
|
|
|
44,243,980 |
|
|
|
|
|
|
|
|
|
|
Convertible notes payable, net of current portion |
|
|
252,163,102 |
|
|
|
286,000,000 |
|
Long-term portion of deferred revenue |
|
|
|
|
|
|
2,083,333 |
|
|
|
|
|
|
|
|
|
|
Shareholders deficit: |
|
|
|
|
|
|
|
|
Preferred stock, no par value: Authorized5,000,000 shares |
|
|
|
|
|
|
|
|
Common
stock, no par value: Authorized100,000,000 shares; issued and outstanding
39,518,492 and 39,452,927 shares at December 31, 2007
and 2006, respectively |
|
|
215,243,310 |
|
|
|
207,388,894 |
|
Warrants |
|
|
613,021 |
|
|
|
613,021 |
|
Accumulated deficit |
|
|
(411,465,815 |
) |
|
|
(361,997,246 |
) |
Accumulated other comprehensive income |
|
|
14,859 |
|
|
|
7,682 |
|
|
|
|
|
|
|
|
Total shareholders deficit |
|
|
(195,594,625 |
) |
|
|
(153,987,649 |
) |
|
|
|
|
|
|
|
Total liabilities and shareholders deficit |
|
$ |
103,139,028 |
|
|
$ |
178,339,664 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
38
ATHEROGENICS, INC.
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
License fees |
|
$ |
27,083,333 |
|
|
$ |
22,916,667 |
|
|
$ |
|
|
Research and development |
|
|
25,193,494 |
|
|
|
8,758,178 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
52,276,827 |
|
|
|
31,674,845 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
72,696,066 |
|
|
|
82,855,340 |
|
|
|
71,278,945 |
|
Marketing, general and administrative |
|
|
13,936,132 |
|
|
|
13,373,112 |
|
|
|
9,050,290 |
|
Restructuring and impairment costs |
|
|
9,996,332 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
96,628,530 |
|
|
|
96,228,452 |
|
|
|
80,329,235 |
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(44,351,703 |
) |
|
|
(64,553,607 |
) |
|
|
(80,329,235 |
) |
Interest and other income |
|
|
6,007,678 |
|
|
|
9,175,817 |
|
|
|
6,691,965 |
|
Interest expense |
|
|
(11,124,544 |
) |
|
|
(8,423,346 |
) |
|
|
(8,917,057 |
) |
Other expense |
|
|
|
|
|
|
(3,521,236 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(49,468,569 |
) |
|
$ |
(67,322,372 |
) |
|
$ |
(82,554,327 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per sharebasic and diluted |
|
$ |
(1.25 |
) |
|
$ |
(1.71 |
) |
|
$ |
(2.19 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstandingbasic and diluted |
|
|
39,500,154 |
|
|
|
39,383,376 |
|
|
|
37,774,203 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
39
ATHEROGENICS, INC.
STATEMENTS OF SHAREHOLDERS DEFICIT
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred |
|
|
|
|
|
|
Other |
|
|
Total |
|
|
|
Common Stock |
|
|
|
|
|
|
Stock |
|
|
Accumulated |
|
|
Comprehensive |
|
|
Shareholders |
|
|
|
Shares |
|
|
Amount |
|
|
Warrants |
|
|
Compensation |
|
|
Deficit |
|
|
(Loss) Income |
|
|
Deficit |
|
Balance at January 1, 2005 |
|
|
37,368,658 |
|
|
$ |
175,713,265 |
|
|
$ |
828,804 |
|
|
$ |
(324,607 |
) |
|
$ |
(212,120,547 |
) |
|
$ |
(39,297 |
) |
|
$ |
(35,942,382 |
) |
Issuance of common stock for exercise of stock options
at $.10 to $14.86 per share |
|
|
727,178 |
|
|
|
2,989,844 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,989,844 |
|
Issuance of common stock for exercise of warrants |
|
|
47,842 |
|
|
|
154,768 |
|
|
|
(154,768 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to market value for variable stock options
and warrants issued to non-employees |
|
|
|
|
|
|
(27,456 |
) |
|
|
(53,813 |
) |
|
|
81,269 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred stock compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
184,293 |
|
|
|
|
|
|
|
|
|
|
|
184,293 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(82,554,327 |
) |
|
|
|
|
|
|
(82,554,327 |
) |
Unrealized loss on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(113,644 |
) |
|
|
(113,644 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(82,667,971 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
38,143,678 |
|
|
|
178,830,421 |
|
|
|
620,223 |
|
|
|
(59,045 |
) |
|
|
(294,674,874 |
) |
|
|
(152,941 |
) |
|
|
(115,436,216 |
) |
Issuance of common stock for exercise of stock options
at $.30 to $16.52 per share |
|
|
224,249 |
|
|
|
1,762,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,762,357 |
|
Issuance of common stock for debt conversion |
|
|
1,085,000 |
|
|
|
17,562,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,562,557 |
|
Adjustments to market value for variable stock options
and warrants issued to non-employees |
|
|
|
|
|
|
(5,433 |
) |
|
|
(7,202 |
) |
|
|
12,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization
of non-employee deferred stock compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46,410 |
|
|
|
|
|
|
|
|
|
|
|
46,410 |
|
Stock-based compensation |
|
|
|
|
|
|
9,238,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,238,992 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(67,322,372 |
) |
|
|
|
|
|
|
(67,322,372 |
) |
Unrealized gain on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
160,623 |
|
|
|
160,623 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(67,161,749 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
39,452,927 |
|
|
|
207,388,894 |
|
|
|
613,021 |
|
|
|
|
|
|
|
(361,997,246 |
) |
|
|
7,682 |
|
|
|
(153,987,649 |
) |
Issuance of common stock for exercise of stock options
at $.30 to $.38 per share |
|
|
65,565 |
|
|
|
23,075 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,075 |
|
Stock-based compensation |
|
|
|
|
|
|
7,831,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,831,341 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(49,468,569 |
) |
|
|
|
|
|
|
(49,468,569 |
) |
Unrealized gain on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,177 |
|
|
|
7,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(49,461,392 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
39,518,492 |
|
|
$ |
215,243,310 |
|
|
$ |
613,021 |
|
|
$ |
|
|
|
$ |
(411,465,815 |
) |
|
$ |
14,859 |
|
|
$ |
(195,594,625 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial statements.
40
ATHEROGENICS, INC.
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(49,468,569 |
) |
|
$ |
(67,322,372 |
) |
|
$ |
(82,554,327 |
) |
Adjustments
to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Asset impairment costs |
|
|
9,005,153 |
|
|
|
|
|
|
|
|
|
Amortization of deferred revenue |
|
|
(27,083,333 |
) |
|
|
(22,916,667 |
) |
|
|
|
|
Stock-based compensation |
|
|
7,831,341 |
|
|
|
9,285,402 |
|
|
|
184,293 |
|
Loss on debt conversion |
|
|
|
|
|
|
3,521,236 |
|
|
|
|
|
Amortization of discount on 4.5% convertible notes due 2011 |
|
|
2,131,852 |
|
|
|
|
|
|
|
|
|
Amortization of debt issuance costs |
|
|
1,646,479 |
|
|
|
1,483,169 |
|
|
|
1,504,172 |
|
Depreciation and amortization |
|
|
911,124 |
|
|
|
972,009 |
|
|
|
808,599 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
3,903,470 |
|
|
|
(6,518,499 |
) |
|
|
|
|
Prepaid expenses |
|
|
3,130,040 |
|
|
|
(1,398,519 |
) |
|
|
(5,603 |
) |
Interest receivable |
|
|
261,216 |
|
|
|
237,702 |
|
|
|
(351,787 |
) |
Accounts payable |
|
|
(2,402,392 |
) |
|
|
995,050 |
|
|
|
(649,592 |
) |
Accrued research and development |
|
|
(7,497,419 |
) |
|
|
6,262,136 |
|
|
|
(136,924 |
) |
Accrued interest |
|
|
336,150 |
|
|
|
68,250 |
|
|
|
1,250,000 |
|
Accrued compensation |
|
|
792,407 |
|
|
|
(1,183,996 |
) |
|
|
1,410,393 |
|
Accrued and other liabilities |
|
|
129,075 |
|
|
|
(519,431 |
) |
|
|
755,076 |
|
Deferred revenue |
|
|
|
|
|
|
50,000,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(56,373,406 |
) |
|
|
(27,034,530 |
) |
|
|
(77,785,700 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and maturities of short-term investments |
|
|
110,008,090 |
|
|
|
138,814,368 |
|
|
|
151,882,055 |
|
Purchases of short-term investments |
|
|
(64,116,085 |
) |
|
|
(102,945,761 |
) |
|
|
(200,633,447 |
) |
Purchases of equipment and leasehold improvements |
|
|
(2,592,365 |
) |
|
|
(5,494,454 |
) |
|
|
(2,977,050 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
43,299,640 |
|
|
|
30,374,153 |
|
|
|
(51,728,442 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from the sale of convertible notes |
|
|
|
|
|
|
|
|
|
|
193,566,977 |
|
Proceeds from the exercise of common stock options |
|
|
23,075 |
|
|
|
1,762,357 |
|
|
|
2,989,844 |
|
Payments on equipment loan |
|
|
|
|
|
|
(87,580 |
) |
|
|
(99,919 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
23,075 |
|
|
|
1,674,777 |
|
|
|
196,456,902 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and cash equivalents |
|
|
(13,050,691 |
) |
|
|
5,014,400 |
|
|
|
66,942,760 |
|
Cash and cash equivalents at beginning of year |
|
|
87,846,079 |
|
|
|
82,831,679 |
|
|
|
15,888,919 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
74,795,388 |
|
|
$ |
87,846,079 |
|
|
$ |
82,831,679 |
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosures of cash flow information |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
7,010,062 |
|
|
$ |
6,871,927 |
|
|
$ |
6,162,886 |
|
The accompanying notes are an integral part of these financial statements.
41
NOTES TO FINANCIAL STATEMENTS
1. Description of Business and Significant Accounting Policies
Description of Business
AtheroGenics, Inc. (AtheroGenics) was incorporated on November 23, 1993 (date of inception)
in the State of Georgia to focus on the discovery, development and commercialization of novel
therapeutics for the treatment of chronic inflammatory diseases, such
as diabetes and coronary heart disease
(atherosclerosis).
Use of Estimates
The preparation of the financial statements in conformity with U.S. generally accepted
accounting principles requires management to make estimates and assumptions that affect the amounts
reported in the financial statements and accompanying notes. Actual results could differ from
those estimates.
Cash and Cash Equivalents
AtheroGenics considers all highly liquid investments with a maturity of three months or less
when purchased to be cash equivalents. AtheroGenics cash equivalents consist primarily of money
market accounts, commercial paper, government agency notes and corporate notes on deposit with
several financial institutions, and the carrying amounts reported in the balance sheets approximate
their fair value.
Short-Term Investments
Short-term investments consist of commercial paper, corporate notes and government agency
notes with original maturities of greater than three months when purchased.
Management determines the appropriate classification of debt securities at the time of
purchase and reevaluates such designation as of each balance sheet date. These investments are
accounted for in accordance with Statement of Financial Accounting Standards, (SFAS) No. 115,
Accounting for Certain Investments in Debt and Equity Securities. AtheroGenics has classified all
investments as available-for-sale. Available-for-sale securities are carried at fair value, with
the unrealized gains and losses, net of tax, reported in a separate component of shareholders
deficit. Realized gains and losses are included in investment income and are determined on a
specific identification basis.
Fair Value of Financial Instruments and Concentration of Credit Risk
Financial instruments that subject AtheroGenics to concentration of credit risk consist
primarily of cash, cash equivalents and short-term investments. These assets are maintained by
reputable third party financial institution custodians. The carrying values reported in the
balance sheets for cash, cash equivalents and short-term investments approximate fair values.
Accounts Receivable
Accounts receivable consists primarily of receivables related to the FOCUS (Follow-up Of
Clinical Outcomes: The Long-term AGI-1067 Plus Usual Care Study) clinical trial which we conducted
for IPR Pharmaceuticals, Inc. (AstraZeneca). As of December 31, 2007, accounts receivable were
$2,634,422.
Equipment and Leasehold Improvements
Equipment and leasehold improvements are stated at cost. Depreciation of computer and lab
equipment is computed using the straight-line method over the estimated useful lives of three and
five years, respectively. Amortization of leasehold improvements is recorded over the shorter of:
(a) the estimated useful lives of the related assets; or (b) the lease term.
42
Research and Development Accrual
As part of the process of preparing its financial statements, AtheroGenics is required
to estimate expenses that it believes it has incurred, but has not yet been billed for. This
process involves identifying services and activities that have been performed by third party
vendors on its behalf and estimating the level to which they have been performed and the associated
cost incurred for such service as of each balance sheet date in its financial statements. Examples
of expenses for which AtheroGenics accrues include fees for professional services, such as those
provided by certain clinical research organizations and investigators in conjunction with clinical
trials, and fees owed to contract manufacturers in conjunction with the manufacture of clinical
trial materials. AtheroGenics makes these estimates based upon progress of activities related to
contractual obligations and also information received from vendors.
Revenue Recognition
AtheroGenics recognizes revenue in accordance with the Securities and Exchange Commissions
Staff Accounting Bulletin (SAB) No. 101, Revenue Recognition in Financial Statements, as amended
by Staff Accounting Bulletin No. 104, Revenue Recognition, (SAB 104). SAB 104 provides guidance
in applying U.S. generally accepted accounting principles to revenue recognition issues, and
specifically addresses revenue recognition for upfront, nonrefundable fees received in connection
with research collaboration agreements.
In accordance with SAB 104, license fees, which are nonrefundable, are recognized when the
related license agreements specify that no further efforts or obligations are required of us. In
February 2006, AtheroGenics received a $50,000,000 license fee in connection with its license and
collaboration agreement with AstraZeneca. The upfront nonrefundable license payment was being
recognized on a straight-line basis over the 24-month period that AtheroGenics estimated it was
obligated to provide services to the licensee. In April 2007, AstraZeneca announced that it was
ending the license and collaboration agreements and any further obligations required of
AtheroGenics. As such, the remaining balance of approximately $20,800,000 in deferred revenue
related to the license fee was recognized as revenue.
During 2006, AstraZeneca separately engaged AtheroGenics to conduct the FOCUS clinical trial.
Revenues under the research and development agreement pertaining clinical trials are recognized in
accordance with SAB 104 and Emerging Issues Task Force (EITF) Issue No. 99-19, Reporting Gross
Revenue as a Principal vs. Net as an Agent (EITF 99-19). According to the criteria established
by EITF. 99-19, AtheroGenics is the primary obligor of the agreement because it is responsible for
the selection, negotiation, contracting and payment of the third party suppliers. In addition, any
liabilities resulting from the agreement are the responsibility of AtheroGenics. Research and
development revenues are recognized, on a gross basis, as activities are performed under the terms
of the related agreement. The FOCUS clinical trial, which has concluded, was fully funded by
AstraZeneca.
Research and Development and Patent Costs
Research and development costs, including all related salaries, clinical trial expenses,
facility costs and expenditures related to obtaining patents, are charged to expense when incurred.
Restructuring and Impairment Costs
In May 2007, AtheroGenics implemented an organizational restructuring plan that reduced its
workforce by approximately 50% to 67 employees. This action was designed to streamline company
operations and was the first step in the strategic plan to continue advancing the development of
AGI-1067. As a result, in accordance with SFAS 146, Accounting for Costs Associated with Exit or
Disposal Activities, AtheroGenics recorded a charge of approximately $1,000,000 for severance in
the second quarter of 2007. As of December 31, 2007, all of the severance had been paid.
In addition to the reduction in workforce, AtheroGenics determined that in accordance with
SFAS 144, Accounting for the Impairment or Disposal of Long-Lived Assets, certain excess laboratory
equipment and related leasehold improvements, as well as commercial manufacturing equipment had
been impaired. As AtheroGenics has no assurance that such assets will be utilized, an impairment
test was performed in accordance with SFAS 144 based on estimates of cash flows associated with the
equipment. Based on the results of this impairment test, AtheroGenics recorded a non-cash
impairment charge of approximately $9,000,000 in the second quarter of 2007.
43
Stock-Based Compensation
On January 1, 2006, AtheroGenics adopted SFAS No. 123(R), Share-Based Payment, (SFAS 123(R))
which requires that companies recognize expense associated with stock option grants and other
equity instruments to employees in the financial statements. AtheroGenics adopted SFAS 123(R)
using the modified prospective method and uses the Black-Scholes option valuation model to measure
the fair value of share-based payments. SFAS 123(R) applies to all grants after the effective date
and to the unvested portion of stock options outstanding as of the effective date.
For the years ended December 31, 2007 and 2006, AtheroGenics recorded approximately $7,800,000
and $9,300,000, respectively, of employee stock-based compensation expense. As a result of
adopting SFAS 123(R), AtheroGenics net loss per share was impacted $(0.20) and $(0.23) for the
years ended December 31, 2007 and 2006, respectively. AtheroGenics has a net operating loss
carryforward as of December 31, 2007 and 2006, and therefore no excess tax benefits for tax
deductions related to the stock options were recognized. As of December 31, 2007, unamortized
stock-based compensation expenses of approximately $13,900,000 remain to be recognized over a
weighted average period of approximately three years.
For the years ended December 31, 2007 and 2006, AtheroGenics calculated a forfeiture rate of
10.31% and 5.66%, respectively, based on historical data. Expected volatility is based on
historical volatility of AtheroGenics common stock. The expected term of the stock options
granted is also based on historical data and represents the period of time that stock options
granted are expected to be outstanding. The risk free interest rate is based on the U.S. Treasury
rates in effect at the time of the grant for periods corresponding with the expected term of the
options. For stock options granted during the twelve months ended December 31, 2007 and 2006 the
following weighted average assumptions were used:
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
|
|
|
|
|
|
|
|
Expected life |
|
4 years |
|
|
5 years |
|
Risk-free interest rate |
|
|
4.3 |
% |
|
|
4.7 |
% |
Volatility |
|
|
83.70 |
% |
|
|
64.92 |
% |
Fair value of grants |
|
$ |
0.94 |
|
|
$ |
7.58 |
|
Prior to the adoption of SFAS 123(R), AtheroGenics accounted for its stock-based compensation
expenses under the provision of APB 25 and related interpretations. Under APB 25, if the exercise
price of employee stock options equals or exceeds the market price of the underlying stock on the
date of grant, no compensation expense was recognized. AtheroGenics had adopted the provisions of
SFAS 123 as amended by SFAS No. 148, Accounting for Stock-Based Compensation Transition and
Disclosure, using pro forma disclosure only.
The following table illustrates the effect on net loss and net loss per share as if the fair
value based method had been applied to all outstanding and unvested options in each period, based
on the provisions of SFAS 123 and SFAS 148.
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
Net loss, as reported |
|
$ |
(82,554,327 |
) |
Add: Stock-based employee compensation expense included
in reported net loss |
|
|
|
|
Deduct: Total stock-based employee compensation expense
determined under fair value based method for
all awards |
|
|
(8,764,619 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss |
|
$ |
(91,318,946 |
) |
|
|
|
|
|
Net loss per share: |
|
|
|
|
Basic and diluted, as reported |
|
$ |
(2.19 |
) |
|
|
|
|
|
Basic and diluted, pro forma |
|
$ |
(2.42 |
) |
|
|
|
|
|
44
The fair value for these options (which are granted with an exercise price equal to fair
market value on the grant date) was estimated using the Black-Scholes option valuation model with
the following weighted average assumptions:
|
|
|
|
|
|
|
2005 |
|
|
|
|
|
Expected life |
|
5 years |
|
Risk-free interest rate |
|
|
4.2 |
% |
Volatility |
|
|
77.75 |
% |
Fair value of grants |
|
$ |
8.80 |
|
Income Taxes
The liability method is used in accounting for income taxes. Deferred income tax assets and
liabilities are determined based on differences between financial reporting and tax bases of assets
and liabilities and are measured using the enacted tax rates and laws that are expected to be in
effect when the differences are anticipated to reverse.
Comprehensive Income (Loss)
AtheroGenics computes comprehensive income (loss) in accordance with SFAS No. 130, Reporting
Comprehensive Income (SFAS 130). SFAS 130 establishes standards for the reporting and display of
comprehensive income (loss) and its components in the financial statements. Comprehensive income
(loss), as defined, includes all changes in equity during a period from non-owner sources, such as
unrealized gains and losses on available-for-sale securities. Comprehensive loss was $49,461,392,
$67,161,749 and $82,667,971 for the years ended December 31, 2007, 2006 and 2005, respectively.
Recently Issued Accounting Standards
In September 2006, the Financial Accounting Standards Board (FASB) issued SFAS No. 157, Fair
Value Measurements, (SFAS 157). SFAS 157 defines fair value, establishes a framework for
measuring fair value in accordance with generally accepted accounting principles (GAAP), and
expands disclosures about fair value measurements. SFAS 157 is effective for fiscal years
beginning after November 17, 2007. AtheroGenics does not believe adoption will have a material
impact on its results of operations.
In February 2007, FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, (SFAS 159). SFAS 159 permits entities to choose to measure many financial
instruments at fair value rather than under other GAAP, such as historical costs. This results in
the financial instrument being marked to fair value every reporting period with the gain or loss
from a change in the fair value recorded in the statement of operations. SFAS 159 is effective for
fiscal years beginning after November 17, 2007. AtheroGenics is currently analyzing the impact, if
any, that SFAS 159 will have on its results of operations.
2. Collaborations
In 2005, AtheroGenics announced a license and collaboration agreement with AstraZeneca for the
global development and commercialization of AGI-1067. Under the terms of the agreement,
AtheroGenics received an upfront nonrefundable license fee of $50,000,000 and, subject to the
achievement of specific milestones including a successful outcome in ARISE (Aggressive Reduction of
Inflammation Stops Events), AtheroGenics was eligible for development and regulatory milestones of
up to an aggregate of $300,000,000. The agreement also provided for progressively demanding sales
performance related milestones of up to an additional $650,000,000 in the aggregate. In addition,
AtheroGenics was to receive royalties on product sales. AstraZeneca was responsible for supplying
all of the manufacturing, packaging and labeling. AstraZeneca had the right to terminate the
license and collaboration agreement at specified periods. In April 2007, AstraZeneca notified us
that pursuant to the terms of the agreement, it was ending the collaboration. The agreement was
terminated in July 2007.
In the second half of 2006, AtheroGenics was engaged separately by AstraZeneca to conduct
FOCUS. FOCUS was a follow-up Phase III clinical trial for patients exiting ARISE, designed to
collect extended safety information. Pursuant to the terms of the license agreement, AstraZeneca
funded the entire cost of the trial which has been concluded.
In 2004, AtheroGenics announced a collaboration with Astellas Pharma Inc. (Formerly Known As
Fujisawa Pharmaceutical Co., Ltd.) to develop AGI-1096 as an oral treatment for the prevention of
organ transplant rejection. Under the agreement, AtheroGenics agreed to collaborate with Astellas
to conduct preclinical and early stage clinical development trials, with Astellas funding all
45
development costs during the term of the agreement. Astellas received an option to negotiate
for late stage development and commercial rights to the compound. Astellas has informed us that
they have completed their current development activities and do not have further development plans.
3. Short-Term Investments
Short-term investments consist of debt securities classified as available-for-sale and have
maturities greater than 90 days from the date of acquisition. AtheroGenics has invested primarily
in corporate notes and commercial paper, all of which have a minimum investment rating of A1/P1,
and government agency notes. There were no realized gains or losses from the sale of investments
for the years ended December 31, 2007 and 2006. The cumulative unrealized gains were $14,859 and
$7,682 at December 31, 2007 and 2006, respectively. The following table summarizes the estimated
fair value of AtheroGenics short-term investments:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Commercial paper |
|
$ |
12,301,963 |
|
|
$ |
22,715,730 |
|
Corporate notes |
|
|
3,776,569 |
|
|
|
12,509,175 |
|
Government agency notes |
|
|
2,001,500 |
|
|
|
28,739,955 |
|
|
|
|
|
|
|
|
Total |
|
$ |
18,080,032 |
|
|
$ |
63,964,860 |
|
|
|
|
|
|
|
|
All available-for-sale securities held at December 31, 2007 will mature during 2008.
4. Equipment and Leasehold Improvements
Equipment and leasehold improvements consist of the following:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Construction-in-progress |
|
$ |
|
|
|
$ |
5,429,178 |
|
Laboratory equipment |
|
|
3,316,350 |
|
|
|
3,382,243 |
|
Leasehold improvements |
|
|
3,107,353 |
|
|
|
3,244,412 |
|
Computer and office equipment |
|
|
2,702,639 |
|
|
|
2,349,797 |
|
|
|
|
|
|
|
|
|
|
|
9,126,342 |
|
|
|
14,405,630 |
|
Accumulated depreciation and amortization |
|
|
(6,765,289 |
) |
|
|
(4,720,665 |
) |
|
|
|
|
|
|
|
Net equipment and leasehold improvements |
|
$ |
2,361,053 |
|
|
$ |
9,684,965 |
|
|
|
|
|
|
|
|
In March 2005, AtheroGenics had committed to purchase certain commercial manufacturing
equipment for AGI-1067, to be delivered in 2006. In March 2006, AstraZeneca assumed this
commitment, and the costs were shared equally between AtheroGenics and AstraZeneca, subject to a
limit on AtheroGenics portion, as part of the joint license and collaboration agreements that were
signed in December 2005. As a result of the termination of the collaboration and transition of
commercial manufacturing equipment by AstraZeneca, this equipment was deemed impaired and
AtheroGenics recorded a non-cash write-down of approximately $7,500,000 in the second quarter of
2007.
In May 2007, AtheroGenics implemented an organizational restructuring and recorded a non-cash
write-down of approximately $1,500,000 for certain excess laboratory equipment and related
leasehold improvements that were deemed impaired.
5. Convertible Notes Payable
In August 2003, AtheroGenics issued $100,000,000 in aggregate principal amount of
4.5% convertible notes due September 1, 2008 (the 2008 Notes) with interest payable semi-annually
in March and September. Net proceeds to AtheroGenics were approximately $96,700,000, after
deducting expenses and underwriters discounts and commissions. The issuance costs related to the
notes are recorded as debt issuance costs and other assets and are being amortized to interest
expense over the five-year life of the notes. The notes may be converted into shares of
AtheroGenics common stock, at the option of the holder, prior to the close of business on
September 1, 2008 at a conversion rate of 65.1890 shares per $1,000 principal amount of notes,
representing a conversion price of approximately $15.34.
46
In January 2006, AtheroGenics exchanged $14,000,000 in aggregate principal amount of the 2008
Notes for approximately 1,100,000 shares of AtheroGenics common stock. In accordance with SFAS No.
84, Induced Conversion of Convertible Debt, this transaction resulted in a non-cash charge of
approximately $3,500,000 related to the premium paid in excess of the conversion price in order to
induce conversion of the notes and the write-off of the portion of debt issuance costs attributable
to the notes converted. This amount is recorded as other expense in the statements of operations.
In July 2007, AtheroGenics extinguished $38,000,000 in aggregate principal amount of the 2008
Notes with certain holders and issued $60,400,000 in aggregate principal amount of 4.5% Convertible
Notes due 2011 (the 2011 Notes). This exchange was accounted for in accordance with EITF 96-19,
Debtors Accounting for a Modification or Exchange of Debt Instruments. The 2011 Notes were
initially recorded at their fair value of $38,000,000. The $22,400,000 difference between the
principal amount and the initial fair value of the 2011 Notes, the discount, will be accreted up to
the face amount of $60,400,000 as additional interest expense over the remaining life of the new
convertible notes. As of December 31, 2007, the remaining balance of the discount on these notes
was approximately $20,300,000.
The terms of the 2011 Notes are substantially similar to the 2008 Notes including the same
customary default events except that the 2011 Notes will mature in March 2011 as opposed to
September 2008. The 2011 Notes, like the 2008 Notes, bear an interest rate of 4.5%, payable
semiannually in arrears on March 1 and September 1.
Like the 2008 Notes, the 2011 Notes are convertible into shares of AtheroGenics common stock
(Shares) at any time prior to the close of business on the final maturity date, subject to
AtheroGenics right to redeem the 2011 Notes prior to their maturity. The initial conversion rate
for the 2011 Notes is 65.1890 Shares per $1,000 principal amount of 2011 Notes.
Also like the 2008 Notes, AtheroGenics may be required to redeem the 2011 Notes on an
accelerated basis if AtheroGenics defaults on certain other debt obligations or if AtheroGenics
common stock or consideration received in exchange for such common stock is not tradable on a
national securities exchange or system of automated quotations.
In January 2008, AtheroGenics redeemed $17,500,000 of its 2008 Notes and, in exchange, issued
$11,500,000 of 4.5% convertible notes due in 2011 along
with $5,500,000 of cash. Based on this
transaction and the guidance in SFAS 6, Classification of Short-Term Obligations Expected to Be
Refinanced, AtheroGenics reclassified, as of December 31, 2007, $12,000,000 from current portion of
convertible notes payable to non-current portion of convertible notes payable. In accordance with
the guidance in SFAS 6, AtheroGenics has the intent and ability to refinance this debt as evidenced
by this January 2008 transaction.
In January 2005, AtheroGenics issued $200,000,000 in aggregate principal amount of
1.5% convertible notes due February 1, 2012 (the 2012
Notes) with interest payable semi-annually in February and
August. Net proceeds to AtheroGenics were approximately $193,600,000, after deducting expenses and
underwriters discounts and commissions. The issuance costs related to the notes are recorded as
debt issuance costs and other assets and are being amortized to interest expense over the
seven-year life of the notes. The 2012 Notes may be converted into shares of
AtheroGenics common stock, at the option of the holder, at a conversion rate of 38.5802 shares per
$1,000 principal amount of notes, which represents a conversion price of approximately $25.92.
The conversion rate for both series of notes is subject to adjustment for stock dividends and
other dilutive transactions. In addition, AtheroGenics Board of Directors may, to the extent
permitted by applicable law, increase the conversion rate provided that the Board of Directors has
determined that such increase is in the best interest of AtheroGenics and such increase remains
effective for a period of at least twenty days. AtheroGenics may also be required to redeem the
notes on an accelerated basis if AtheroGenics defaults on certain other debt obligations or if
AtheroGenics common stock or consideration received in exchange for such common stock is not
tradable on a national securities exchange or system of automated quotations.
As of December 31, 2007, AtheroGenics has reserved a total of 14,783,194 shares of common
stock for future issuance in connection with the 2008 Notes, the 2011 Notes and the 2012 Notes. In
addition, as of December 31, 2007, there was approximately $1,600,000 of accrued interest related
to the 2008 Notes and the 2011 Notes, which is due March 1, 2008, and $1,300,000 of accrued
interest related to the 2012 Notes, which is due February 1, 2008.
47
Maturities of long-term debt as of December 31, 2007 are as follows:
|
|
|
|
|
4.5% convertible notes due 2008 |
|
$ |
35,968,750 |
|
|
|
|
|
|
|
|
|
|
4.5% convertible notes due 2011 |
|
|
72,441,250 |
|
1.5 % convertible notes due 2012 |
|
|
200,000,000 |
|
|
|
|
|
Face value of convertible notes due 2011 and 2012 |
|
|
272.441.250 |
|
Discount on the notes due 2011 |
|
|
(20,278,148 |
) |
|
|
|
|
Total 2011 Notes and 2012 Notes |
|
$ |
252,163,102 |
|
|
|
|
|
6. Net Loss Per Share
SFAS No. 128, Earnings per Share, requires presentation of both basic and diluted earnings per
share. Basic earnings per share is computed by dividing net income (loss) by the weighted average
number of shares of common stock outstanding during the period. Diluted earnings per share is
computed in the same manner as basic earnings per share except that diluted earnings per share
reflects the potential dilution that would occur if outstanding options, warrants and convertible
notes payable were exercised.
During all periods presented, AtheroGenics had securities outstanding that could potentially
dilute basic earnings per share in the future, but were excluded from the computation of diluted
net loss per share, as their effect would have been antidilutive. These outstanding securities
consist of the following at the dates indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares underlying convertible notes |
|
|
14,783,194 |
|
|
|
13,322,307 |
|
|
|
14,234,953 |
|
Options |
|
|
6,600,816 |
|
|
|
6,521,524 |
|
|
|
4,375,632 |
|
Warrants |
|
|
82,436 |
|
|
|
82,436 |
|
|
|
82,436 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
21,466,446 |
|
|
|
19,926,267 |
|
|
|
18,693,021 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average conversion price of shares underlying
convertible notes |
|
$ |
20.86 |
|
|
$ |
21.47 |
|
|
$ |
22.39 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average exercise price of options |
|
$ |
8.56 |
|
|
$ |
11.73 |
|
|
$ |
11.17 |
|
|
|
|
|
|
|
|
|
|
|
Weighted average exercise price of warrants |
|
$ |
5.64 |
|
|
$ |
5.64 |
|
|
$ |
5.64 |
|
|
|
|
|
|
|
|
|
|
|
Because AtheroGenics reported a net loss for all periods presented, shares associated with
stock options, warrants and the convertible notes are not included because they are antidilutive.
Basic and diluted net loss per share amounts are the same for the periods presented.
7. Common Stock
In November 2001, AtheroGenics Board of Directors adopted a Shareholder Rights Plan,
declaring a dividend distribution of one common stock purchase right on each outstanding share of
its common stock. Until the rights become exercisable, the rights will trade automatically with
the common stock of AtheroGenics and separate rights certificates will not be issued. Under the
rights plan, each right consists of an initial right and subsequent rights. Initial rights will be
exercisable only if a person or group acquires 15% or more of AtheroGenics common stock, whether
through open market or private purchases or consummation of a tender or exchange offer. If,
following the exercise of initial rights, a person or group again acquires 15% or more of
AtheroGenics common stock, or a person or group who had previously acquired 15% or more of
AtheroGenics common stock acquires an additional 10% or more of the common stock, the subsequent
rights become exercisable. Each right will initially entitle shareholders to buy eight shares of
common stock at an exercise price equal to 20% of the then current market value of the common
stock, calculated and adjusted according to the terms of the rights plan. The number of shares
that can be purchased upon exercise will increase as the number of shares held by the bidder
increases.
If AtheroGenics is acquired in a merger or other business combination, each right will entitle
its holder to purchase, at the rights then-current exercise price, a number of the acquiring
companys shares equal in value to those obtainable if the rights were exercisable in AtheroGenics
common stock.
48
The rights are intended to enable all shareholders to realize the long-term value of their
investment in AtheroGenics. They will not prevent a takeover, but should encourage anyone seeking
to acquire AtheroGenics to negotiate with the Board of Directors prior to attempting a takeover.
The Board of Directors may redeem any non-exercisable rights at any time at its option at a
redemption price of $.0001 per right. The rights plan expires at the close of business on November
8, 2011.
8. Stock Options and Warrants
During 1997, AtheroGenics established an equity ownership plan (the 1997 Plan) whereby
options to purchase AtheroGenics common stock may be granted to employees, directors, consultants
or contractors with exercise prices not less than the fair value of the shares on the dates of
grant. The 1997 Plan, as amended, authorizes the grant of options for up to 3,724,416 shares of
AtheroGenics common stock. The 1997 Plan expired in 2007 and 119,475 shares that were available
for grant expired. As of December 31, 2007, AtheroGenics had 1,298,087 shares of common stock
reserved for issuance under the 1997 Plan in connection with outstanding options.
During 2001, AtheroGenics established an equity ownership plan (the 2001 Plan) whereby
options to purchase AtheroGenics common stock may be granted to employees, directors, consultants
or contractors with exercise prices not less than the fair value of the shares on the dates of
grant. The 2001 Plan allows for grants of non-qualified options, incentive stock options and
shares of restricted stock. Non-qualified options granted under the 2001 Plan may vest immediately
for non-employees, but generally vest over a four-year period for employees. Incentive stock
options generally vest over four years. The 2001 Plan authorizes the grant of options for up to
2,000,000 shares of AtheroGenics common stock. As of December 31, 2007, AtheroGenics had
1,563,464 shares of common stock reserved for issuance under the 2001 Plan in connection with
outstanding options or future grants.
During 2004, AtheroGenics established an equity ownership plan (the 2004 Plan) whereby
options to purchase AtheroGenics common stock may be granted to employees, directors, consultants
or contractors with exercise prices not less than the fair value of the shares on the dates of
grant. The 2004 Plan authorizes the grant of options for up to 4,500,000 shares of AtheroGenics
common stock. As of December 31, 2007, AtheroGenics had 4,484,000 shares of common stock reserved
for issuance under the 2004 Plan in connection with outstanding options or future grants. The
terms of the 2004 Plan are substantially similar to the terms of the 2001 Plan.
A summary of stock option activity under previous plans, the 1997 Plan, the 2001 Plan and the
2004 Plan follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
Weighted |
|
Remaining |
|
Aggregate |
|
|
Number of |
|
Average |
|
Contractual |
|
Intrinsic |
|
|
Shares |
|
Exercise Price |
|
Life |
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at January 1, 2005 |
|
|
4,955,801 |
|
|
$ |
10.20 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
317,900 |
|
|
|
13.46 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(727,178 |
) |
|
|
4.11 |
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(170,891 |
) |
|
|
17.49 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2005 |
|
|
4,375,632 |
|
|
|
11.17 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,548,347 |
|
|
|
12.84 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(224,249 |
) |
|
|
7.86 |
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(178,206 |
) |
|
|
18.71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2006 |
|
|
6,521,524 |
|
|
|
11.73 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,829,196 |
|
|
|
1.56 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(65,565 |
) |
|
|
.35 |
|
|
|
|
|
|
|
|
|
Canceled |
|
|
(1,684,339 |
) |
|
|
13.53 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2007 |
|
|
6,600,816 |
|
|
$ |
8.56 |
|
|
|
6.45 |
|
|
$ |
18,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at December 31, 2007 |
|
|
6,148,930 |
|
|
$ |
8.76 |
|
|
|
6.28 |
|
|
$ |
18,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2007 |
|
|
3,880,652 |
|
|
$ |
9.92 |
|
|
|
4.89 |
|
|
$ |
18,440 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49
The total intrinsic value of options exercised during the years ended December 31, 2007, 2006
and 2005 was $255,936, $2,036,178 and $9,796,231, respectively. Cash received from option
exercises during the years ended December 31, 2007, 2006 and 2005 was $23,075, $1,762,357 and
$2,989,844, respectively. AtheroGenics has a net operating loss carryforward as of December 31,
2007, and therefore no excess tax benefits for tax deductions related to the stock options were
recognized.
The following table summarizes information concerning currently outstanding and exercisable
options granted under the 1997 Plan, the 2001 Plan and the 2004 Plan as of December 31, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
Options Exercisable |
|
|
Number |
|
Weighted Average |
|
Weighted Average |
|
Number |
|
Weighted Average |
Exercise Price |
|
Outstanding |
|
Remaining Years |
|
Exercise Price |
|
Exercisable |
|
Exercise Price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$.30- $2.14
|
|
|
1,696,617 |
|
|
|
5.58 |
|
|
$ |
.45 |
|
|
|
896,450 |
|
|
$ |
.41 |
|
2.41 - 7.41
|
|
|
1,705,695 |
|
|
|
6.37 |
|
|
|
4.40 |
|
|
|
957,644 |
|
|
|
5.96 |
|
7.55 - 14.86
|
|
|
1,813,674 |
|
|
|
7.02 |
|
|
|
11.81 |
|
|
|
1,115,250 |
|
|
|
12.53 |
|
14.93 - 32.95
|
|
|
1,384,830 |
|
|
|
6.86 |
|
|
|
19.39 |
|
|
|
911,308 |
|
|
|
20.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
.30 - 32.95
|
|
|
6,600,816 |
|
|
|
6.45 |
|
|
$ |
8.56 |
|
|
|
3,880,652 |
|
|
|
9.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2006 and 2005, AtheroGenics recorded a total of $46,410 and $184,293, respectively, of
amortization of deferred stock compensation related to options and warrants which had been granted
to non-employees in prior years. At December 31, 2007, warrants to purchase 56,000 shares of
AtheroGenics common stock remain outstanding which were issued in connection with a license
agreement in 2001.
9. Employee Benefit Plan
AtheroGenics has a defined contribution plan covering eligible employees, which is qualified
under Section 401(k) of the Internal Revenue Code (IRC). Under the provisions of the plan,
eligible participating employees may elect to contribute up to the maximum amount of tax deferred
contribution allowed by the IRC. AtheroGenics may make a
discretionary contribution. During 2007,
AtheroGenics matched 50% of employees contributions, up to a maximum of 6% of the employees
annual base compensation. AtheroGenics contributions to the plan for 2007, 2006 and 2005
aggregated $254,197, $261,098 and $237,652, respectively. AtheroGenics stock is not an eligible
investment under this plan.
10. Income Taxes
AtheroGenics income tax expense was $0 for years ended December 31, 2007, 2006 and 2005. The
primary factors causing income tax expense to be different than the federal statutory rates are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Incomes tax benefit at statutory rate |
|
$ |
(16,819,314 |
) |
|
$ |
(22,889,606 |
) |
|
$ |
(28,068,471 |
) |
Incentive stock options |
|
|
1,713,073 |
|
|
|
2,132,144 |
|
|
|
|
|
State income tax benefit net of federal tax benefit |
|
|
(1,758,635 |
) |
|
|
(2,416,408 |
) |
|
|
(3,269,151 |
) |
General business credit |
|
|
(1,583,721 |
) |
|
|
(2,663,331 |
) |
|
|
(2,965,400 |
) |
Loss on debt conversion |
|
|
1,121,880 |
|
|
|
|
|
|
|
|
|
Other |
|
|
137,635 |
|
|
|
9,695 |
|
|
|
(136,356 |
) |
Valuation allowance |
|
|
17,189,082 |
|
|
|
25,827,506 |
|
|
|
34,439,378 |
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
50
At December 31, 2007, AtheroGenics had net operating loss carryforwards and research and
development credit carryforwards of $387,791,865 and $13,607,265, respectively, for income tax
purposes, which both begin to expire in 2010. The significant components of the deferred tax assets
are:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
146,807,285 |
|
|
$ |
125,480,818 |
|
Research credits |
|
|
13,607,265 |
|
|
|
12,023,544 |
|
Impairment reserve |
|
|
3,414,258 |
|
|
|
|
|
Deferred stock compensation |
|
|
2,355,798 |
|
|
|
1,380,850 |
|
Deferred revenue |
|
|
|
|
|
|
10,280,833 |
|
Other |
|
|
633,067 |
|
|
|
462,546 |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
166,817,673 |
|
|
|
149,628,591 |
|
Valuation allowance |
|
|
(166,817,673 |
) |
|
|
(149,628,591 |
) |
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Because of AtheroGenics lack of earnings history, the deferred tax assets have been fully
offset by a valuation allowance. The valuation allowance increased $17,189,082 and $25,827,506 in
2007 and 2006 as follows:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
Deferred tax valuation allowance at beginning of year |
|
$ |
149,628,591 |
|
|
$ |
123,801,085 |
|
Change in cumulative tax differences |
|
|
17,189,082 |
|
|
|
25,827,506 |
|
|
|
|
|
|
|
|
Deferred tax valuation allowance at end of year |
|
$ |
166,817,673 |
|
|
$ |
149,628,591 |
|
|
|
|
|
|
|
|
AtheroGenics net operating loss carryforwards and research and development credit
carryforwards may be subject to certain IRC Section 382 and Section 383 limitations on annual
utilization in the event of changes in ownership. These limitations could significantly reduce the
amount of the net operating loss carryforwards available in the future. The utilization of the
carryforwards is dependent upon the timing and extent of AtheroGenics future profitability. The
annual limitations combined with the expiration dates of the carryforwards may prevent the
utilization of all of the net operating loss and research and development credit carryforwards if
AtheroGenics does not attain sufficient profitability by the expiration dates of the carryforwards.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes-an Interpretation of FASB Statement No. 109 (FIN 48), which provides criteria for the
recognition, measurement, presentation and disclosure of uncertain tax positions. AtheroGenics
adopted the provision of FIN 48 on January 1, 2007. AtheroGenics has no uncertain tax positions
and no cumulative adjustment was required or recorded as a result of the implementation of FIN 48.
As of January 1, 2007 and December 31, 2007, AtheroGenics had no unrecognized tax benefits.
AtheroGenics will recognize accrued interest and penalties related to unrecognized tax benefits in
income tax expense if and when incurred. AtheroGenics has no interest or penalties related to
unrecognized tax benefits accrued as of December 31, 2007. AtheroGenics does not anticipate that
unrecognized benefits will be incurred within the next 12 months. Since AtheroGenics has tax net
operating losses since inception, all tax years remain open under federal and state statute of
limitations.
11. Commitments and Contingencies
On June 19, 1998, AtheroGenics entered into a ten-year operating lease for office and
laboratory space through March 1, 2009. Monthly lease payments of approximately $89,400 began
March 2, 1999, the date occupancy commenced. These payments are subject to increases during each
successive 12-month period based on changes in the Consumer Price Index (CPI). Future increases
in monthly lease payments due to increases in the CPI are considered to be contingent rentals, and,
therefore, will be charged to expense over the lease term as they become payable. AtheroGenics may
extend the lease term for two successive five-year periods. AtheroGenics other operating lease
obligations are not significant.
51
At December 31, 2007, AtheroGenics minimum aggregate commitments under long-term,
non-cancelable operating leases are as follows:
|
|
|
|
|
2008 |
|
$ |
1,269,462 |
|
2009 |
|
|
212,897 |
|
2010 |
|
|
1,755 |
|
Thereafter |
|
|
|
|
|
|
|
|
|
|
$ |
1,484,114 |
|
|
|
|
|
Net rent expense under operating leases amounted to $1,329,812, $1,351,190 and $1,161,682 in
2007, 2006 and 2005, respectively.
As of February 25, 2008, AtheroGenics had approximately $30,500,000 of 2008 Notes outstanding,
which amount will become due on September 1, 2008. Although AtheroGenics expects to have enough
cash on hand to repay all amounts due pursuant to the 2008 Notes and fund the 2008 operations, this
repayment will leave substantially less cash to fund ongoing operations during 2009. AtheroGenics
strategy is to raise additional capital, enter into collaboration arrangements to fund the
development and commercialization of AGI-1067, or restructure its 2008 Notes before they become
due. In addition, AtheroGenics received notices from Nasdaq of violations of two listing
standards: (1) failure to maintain a market value of listed securities above $50,000,000 and (2)
failure to maintain a closing bid price of our common stock above $1.00. If AtheroGenics common
stock fails to be listed on the Nasdaq Global Market or another national securities exchange, each
holder of the notes will have the right to require AtheroGenics to redeem the notes at face value.
If the maturity of the outstanding notes were accelerated AtheroGenics would attempt to refinance
or restructure these obligations. If AtheroGenics does not have sufficient liquidity to fund
operations or pay any of its debt when due, it may seek relief under Title 11 of the U.S. Code (the
Bankruptcy Code) at some point in the future.
12. Subsequent Events
On
January 8, 2008, AtheroGenics issued approximately $11,500,000 in aggregate principal amount of its 2011 Notes
and approximately $5,500,000 in cash consideration to certain holders (the Holders) of $17,500,000 in aggregate
principal amount of its 2008 Notes. The terms of the 2011 Notes are substantially similar to the
2008 Notes including the same customary events of default, except that the 2011 Notes will mature
in March 2011 as opposed to September 2008.
13. Quarterly Results of Operations (Unaudited)
The following is a summary of the unaudited quarterly results of operations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2007 |
|
|
|
|
1st
Quarter |
|
2nd
Quarter |
|
3rd
Quarter |
|
4th
Quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
11,461,252 |
|
|
$ |
30,258,704 |
|
|
$ |
7,438,867 |
|
|
$ |
3,118,004 |
|
Operating loss |
|
|
(12,448,526 |
) |
|
|
(5,655,021 |
) |
|
|
(12,466,120 |
) |
|
|
(13,782,036 |
) |
Net loss |
|
|
(12,652,624 |
) |
|
|
(6,138,681 |
) |
|
|
(14,675,467 |
) |
|
|
(16,001,797 |
) |
Net loss per share data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
(0.32 |
) |
|
|
(0.16 |
) |
|
|
(0.37 |
) |
|
|
(0.40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2006 |
|
|
|
|
1st
Quarter |
|
2nd
Quarter |
|
3rd
Quarter |
|
4th
Quarter |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
4,166,667 |
|
|
$ |
6,250,000 |
|
|
$ |
10,292,683 |
|
|
$ |
10,965,495 |
|
Operating loss |
|
|
(15,801,288 |
) |
|
|
(13,369,049 |
) |
|
|
(14,625,330 |
) |
|
|
(20,757,940 |
) |
Net loss |
|
|
(19,224,807 |
) |
|
|
(13,056,223 |
) |
|
|
(14,373,320 |
) |
|
|
(20,668,022 |
) |
Net loss per share data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
(0.49 |
) |
|
|
(0.33 |
) |
|
|
(0.36 |
) |
|
|
(0.52 |
) |
Because of the method used in calculating per share data, the quarterly per share data will
not necessarily add to the per share data as computed for the year.
52
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Managements annual report on internal control over financial reporting. Section 404 of the
Sarbanes-Oxley Act of 2002 requires management to include in this Annual Report on Form 10-K a
report on the effectiveness of our internal control over financial reporting. Managements annual
report on internal control over financial reporting and the related report from our
independent registered public accounting firm are located in Item 8 of this Form 10-K and are
incorporated herein by reference.
Evaluation of disclosure controls and procedures. Our chief executive officer and chief
financial officer are responsible for establishing and maintaining disclosure controls and
procedures (as defined in the Securities Exchange Act of 1934 Rules 13a-15(e) and 15d-15(e)) for
AtheroGenics. Our chief executive officer and chief financial officer, after evaluating the
effectiveness of our disclosure controls and procedures as of the end of the period covered by this
annual report, have concluded that our disclosure controls and procedures are effective to ensure
that information required to be disclosed in the reports that we file or submit under the Exchange
Act is accumulated and communicated to our management, including our chief executive officer and
chief financial officer, to allow timely decisions regarding required disclosure.
Changes in internal control over financial reporting. There were no changes in our internal
control over financial reporting that occurred during our most recent fiscal quarter that have
materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Item 9B. Other Information
None.
PART III
Item 10. Directors, Executive Officers and Corporate Governance
We have set forth information relating to the directors and executive officers and compliance
with Section 16(a) of the Securities Exchange Act of 1934 under the captions Nominees, Executive
Officers and Directors, Board Meetings and Committees and Section 16(a) Beneficial Ownership
Reporting Compliance, respectively, in our proxy statement for our 2008 annual meeting of
shareholders to be held on May 22, 2008. We are incorporating this information by reference in
this Form 10-K. Our definitive proxy statement will be filed with the SEC no later than 120 days
after December 31, 2007.
Code of Ethics
We have adopted a code of business conduct and ethics for directors, officers and employees,
including our principal executive officer and principal financial officer, known as the
AtheroGenics, Inc. Code of Business Conduct and Ethics. This is available on our website at
http:// www.atherogenics.com or you may request a free copy from:
AtheroGenics, Inc.
Attention: Investor Relations
8995 Westside Parkway
Alpharetta, Georgia 30004
(678) 336-2500
http://www.investor@atherogenics.com
53
Item 11. Executive Compensation
We have set forth information relating to executive compensation under the captions Director
Compensation, Executive Compensation, Employment Agreements and Compensation Committee
Interlocks and Insider Participation in the proxy statement referred to in Item 10 above. We are
incorporating this information by reference in this Form 10-K.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder
Matters
We have set forth information relating to ownership of our common stock by certain persons and
to our equity compensation plans under the captions Security Ownership of Certain Beneficial
Owners and Management and Equity Compensation Plan Information, respectively, in the proxy
statement referred to in Item 10 above. We are incorporating this information by reference in this
Form 10-K.
Item 13. Certain Relationships and Related Transactions, and Director Independence
We have set forth information relating to existing or proposed relationships or transactions
between us and certain of our affiliates under the caption Certain Relationships and Related
Transactions in the proxy statement referred to in Item 10 above. We are incorporating this
information by reference in this Form 10-K.
Item 14. Principal Accountant Fees and Services
We have set forth information relating to our principal accountant fees and services under the
caption Principal Accountant Fees and Services in the proxy statement referred to in Item 10
above. We are incorporating this information by reference in this Form 10-K.
PART IV
Item 15. Exhibits and Financial Statement Schedules
|
(1) |
|
Financial Statements, filed as part of this report |
|
|
|
|
Report of Independent Registered Public Accounting Firm on Internal Control |
|
|
|
|
Report of Independent Registered Public Accounting Firm on Financial Statements |
|
|
|
|
Balance Sheets as of December 31, 2007 and 2006 |
|
|
|
|
Statements of Operations for the years ended December 31, 2007, 2006 and 2005 |
|
|
|
|
Statements Shareholders Deficit for the years ended December 31, 2007, 2006 and
2005 |
|
|
|
|
Statements of Cash Flows for the years ended December 31, 2007, 2006 and 2005 |
|
|
|
|
Notes to Financial Statements |
|
|
(2) |
|
Financial Statement Schedules |
|
|
|
|
No financial statement schedules are provided, because the information called for
is not required or is shown either in the financial statements or the notes
thereto. |
54
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
3.01
|
|
|
|
Fourth Amended and Restated Articles of Incorporation
of AtheroGenics, Inc. (filed as Exhibit 3.01 to
Amendment No. 1 to AtheroGenics Annual Report on
Form 10-K for the year ended December 31, 2004 on
April 6, 2005 and incorporated herein by reference). |
|
|
|
|
|
3.02
|
|
|
|
Third Amended and Restated Bylaws of AtheroGenics,
Inc., as amended (filed as Exhibit 3.02 to
AtheroGenics Annual Report on Form 10-K for the year
ended December 31, 2001 and incorporated herein by
reference). |
|
|
|
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3.03
|
|
|
|
Amendment No. 1 to Third Amended and Restated Bylaws
of AtheroGenics, Inc. (filed as Exhibit 3.02 to
AtheroGenics Current Report on Form 8-K on December
8, 2006 and incorporated herein by reference). |
|
|
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4.01
|
|
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|
Form of Common Stock Certificate (filed as Exhibit
4.01 to Amendment No. 4 to AtheroGenics Registration
Statement on Form S-1, Registration No. 333-31140, on
August 4, 2000 and incorporated herein by reference). |
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4.02
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|
Rights Agreement dated as of November 9, 2001 between
AtheroGenics, Inc. and American Stock Transfer &
Trust Company, as Rights Agent (filed as Exhibit 4.4
of AtheroGenics Form 8-K on November 19, 2001 and
incorporated herein by reference). |
|
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4.03
|
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|
Indenture dated August 19, 2003 between AtheroGenics,
Inc. and The Bank of New York Trust Company of
Florida N.A., as Trustee (filed as Exhibit 4.1 to
AtheroGenics Registration Statement on Form S-3,
Registration No. 333-110160, on October 31, 2003 and
incorporated herein by reference). |
|
|
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4.04
|
|
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|
Global 41/2% Convertible Note Due 2008 (filed as
Exhibit 4.04 to Amendment No. 1 to AtheroGenics
Annual Report on Form 10-K for the year ended
December 31, 2004 on April 6, 2005 and incorporated
herein by reference). |
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4.05
|
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|
Indenture dated January 12, 2005 between
AtheroGenics, Inc. and The Bank of New York Trust
Company of Florida N.A., as Trustee, including the
form of Global 1.50% Convertible Note Due 2012 filed
as Exhibit A thereto (filed as Exhibit 4.5 to
AtheroGenics Registration Statement on Form S-3,
Registration No. 333-123895, on April 6, 2005 and
incorporated herein by reference). |
|
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4.06
|
|
|
|
Indenture dated July 11, 2007 between AtheroGenics,
Inc. and The Bank of New York Trust Company of
Florida N.A., as Trustee (filed as Exhibit 4.1 to
AtheroGenics Current Report on Form 8-K, on July 12,
2007 and incorporated herein by reference). |
|
|
|
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10.01
|
|
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|
Amended and Restated Master Rights Agreement dated
October 31, 1995, as amended by First Amendment dated
November 1, 1995; Second Amendment dated July 30,
1996; Third Amendment dated April 13, 1999; Fourth
Amendment dated May 11, 1999; and Fifth Amendment
dated August 30, 1999 (filed as Exhibit 4.02 to
AtheroGenics Registration Statement on Form S-1,
Registration No. 333-31140, on February 25, 2000 and
incorporated herein by reference). |
|
|
|
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10.02+
|
|
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|
Exclusive License Agreement dated July 17, 1998
between The Regents of the University of California
and AtheroGenics, Inc. (filed as Exhibit 10.02 to
Amendment No. 4 to AtheroGenics Registration
Statement on Form S-1, Registration No. 333-31140, on
August 4, 2000 and incorporated herein by reference). |
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10.03+
|
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|
License Agreement dated January 11, 1995 between
Emory University and AtheroGenics, Inc. (filed as
Exhibit 10.03 to Amendment No. 2 to AtheroGenics
Registration Statement on Form S-1, Registration No.
333-31140, on July 13, 2000 and incorporated herein
by reference). |
|
|
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10.04+
|
|
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|
Patent Purchase Agreement dated April 26, 1995
between AtheroGenics, Inc. and Sampath Parthasarathy,
together with Services Agreement dated April 26, 1995
between AtheroGenics, Inc. and Sampath Parthasarathy
(filed as Exhibit 10.04 to Amendment No. 2 to
AtheroGenics Registration Statement on Form S-1,
Registration No. 333-31140, on July 13, 2000 and
incorporated herein by reference). |
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|
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10.05+
|
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|
Sponsored Research Agreement dated October 14, 1996
between Emory University and AtheroGenics, Inc.
(filed as Exhibit 10.05 to Amendment No. 2 to
AtheroGenics Registration Statement on Form S-1,
Registration No. 333-31140, on July 13, 2000 and
incorporated herein by reference). |
55
|
|
|
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|
10.06#
|
|
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|
AtheroGenics, Inc. 1997 Equity Ownership Plan, as amended by Amendment No. 1 and
Amendment No. 2 (filed as Exhibit 10.08 to Amendment No. 2 to AtheroGenics Registration
Statement on Form S-1, Registration No. 333-31140, on July 13, 2000 and incorporated
herein by reference). |
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10.07
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|
Preferred Shares Purchase Warrant dated August 24, 1998 between AtheroGenics, Inc. and
certain Lenders named therein (filed as Exhibit 10.09 to AtheroGenics Registration
Statement on Form S-1, Registration No. 333-31140, on February 25, 2000 and incorporated
herein by reference). |
|
|
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|
10.08
|
|
|
|
Series C Convertible Preferred Stock Purchase Warrants of AtheroGenics, Inc. (filed as
Exhibit 10.10 to AtheroGenics Registration Statement on Form S-1, Registration No.
333-31140, on February 25, 2000 and incorporated herein by reference). |
|
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10.09++
|
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|
|
Lease Agreement dated June 19, 1998 between Cousins Properties, Inc. and AtheroGenics,
Inc. (filed as Exhibit 10.12 to AtheroGenics Registration Statement on Form S-1,
Registration No. 333-31140, on February 25, 2000 and incorporated herein by reference). |
|
|
|
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|
10.10+
|
|
|
|
Exclusive License Agreement dated as of June 29, 2001 between AtheroGenics, Inc. and
National Jewish Medical and Research Center (filed as Exhibit 10.17 to Amendment No. 1
to AtheroGenics Registration Statement on Form S-1, Registration No. 333-64228, on
July 23, 2001 and incorporated herein by reference). |
|
|
|
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|
10.11#
|
|
|
|
AtheroGenics, Inc. 2004 Equity Ownership Plan (filed as Appendix B to the proxy
statement on Schedule 14A for AtheroGenics 2004 Annual Shareholders Meeting as filed
on March 26, 2004 and incorporated herein by reference). |
|
|
|
|
|
10.12#
|
|
|
|
AtheroGenics, Inc. 2004 Equity Ownership Plan form of incentive equity ownership
agreement and form of directors nonqualified equity ownership agreement (filed as
Exhibit 10.33 to AtheroGenics Annual Report on Form 10-K for the year ended December
31, 2004 on March 16, 2005 and incorporated herein by reference). |
|
|
|
|
|
10.13#
|
|
|
|
Summary of non-employee director compensation (filed as the first paragraph under the
caption Director Compensation in the proxy statement on Schedule 14A for AtheroGenics
2005 Annual Meeting of Shareholders as filed with the SEC on March 28, 2005 and
incorporated herein by reference). |
|
|
|
|
|
10.14#
|
|
|
|
Summary of non-employee directors compensation and 2005 executive officers target cash
incentive (filed under Item 1.01 of AtheroGenics, Inc. Form 8-K on April 29, 2005 and
incorporated herein by reference). |
|
|
|
|
|
10.15+
|
|
|
|
First Amendment dated August 3, 2005 to License Agreement dated January 11, 1995 between
AtheroGenics, Inc. and Emory University (filed as Exhibit 10.1 to AtheroGenics
Quarterly Report on Form 10-Q for the quarter ended September 30, 2005 and incorporated
herein by reference). |
|
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10.16
|
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|
|
Registration Rights Agreement dated January 12, 2005 among AtheroGenics, Inc., as
Issuer, and Morgan Stanley & Co. Incorporated, Lehman Brothers, Inc., JPMorgan
Securities, Inc. and Lazard Freres & Co., as Initial Purchasers (filed as Exhibit 99.1
to AtheroGenics Current Report on Form 8-K on January 13, 2005 and incorporated herein
by reference). |
|
|
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|
10.17+
|
|
|
|
License and Collaboration Agreement between AtheroGenics, Inc and IPR Pharmaceuticals,
LP, dated December 22, 2005 (filed as Exhibit 10.35 to AtheroGenics Annual Report on
Form 10-K for the year ended December 31, 2005 and incorporated herein by reference). |
|
|
|
|
|
10.18+
|
|
|
|
Co-Promotion Agreement by and between AstraZeneca Pharmaceuticals LP and AtheroGenics,
Inc., dated as of December 22, 2005 (filed as Exhibit 10.36 to AtheroGenics Annual
Report on Form 10-K for the year ended December 31, 2005 and incorporated herein by
reference). |
|
|
|
|
|
10.19+
|
|
|
|
Transition Services Agreement, by and between IPR Pharmaceuticals, LP and AtheroGenics,
Inc., dated December 22, 2005 (filed as Exhibit 10.37 to AtheroGenics Annual Report on
Form 10-K for the year ended December 31, 2005 and incorporated herein by reference). |
|
|
|
|
|
10.20#
|
|
|
|
AtheroGenics, Inc. 2004 Equity Ownership Plan form of nonqualified equity ownership
agreement (filed as Exhibit 10.02 to AtheroGenics Current Report on Form 8-K on March
10, 2006 and incorporated herein by reference). |
|
|
|
|
|
10.21
|
|
|
|
Form of Indemnification Agreement dated July 5, 2006 (filed as Exhibit 10.1 to
AtheroGenics Current Report on Form 8-K on July 6, 2006 and incorporated herein by
reference). |
|
|
|
|
|
10.22#
|
|
|
|
Employment Agreement dated September 25, 2006 between AtheroGenics, Inc. and Robert A.D.
Scott (filed as Exhibit 10.3 to AtheroGenics Current Report on Form 8-K on September
29, 2006 and incorporated herein by reference). |
56
|
|
|
|
|
10.23*#
|
|
|
|
Employment Agreement dated December 14. 2007 between AtheroGenics, Inc. and Russell M.
Medford. |
|
|
|
|
|
10.24*#
|
|
|
|
Employment Agreement dated December 14, 2007 between AtheroGenics, Inc. and Mark P.
Colonnese. |
|
|
|
|
|
10.25*#
|
|
|
|
Employment Agreement dated February 13, 2008 between AtheroGenics, Inc. and W. Charles
Montgomery. |
|
|
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|
|
10.26*#
|
|
|
|
Employment Agreement dated February 13, 2008 between AtheroGenics, Inc. and Joseph M.
Gaynor, Jr |
|
|
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|
23.01*
|
|
|
|
Consent of Ernst & Young LLP. |
|
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24.01*
|
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|
|
Powers of Attorney. |
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31.1*
|
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|
|
Certifications of Chief Executive Officer under Rule 13a-14(a). |
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31.2*
|
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|
Certifications of Chief Financial Officer under Rule 13a-14(a). |
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32*
|
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|
|
Certifications of Chief Executive Officer and Chief Financial Officer under Section 1350. |
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* |
|
Filed herewith. |
|
+ |
|
Certain confidential information contained in this document has been
omitted and filed separately with the Commission pursuant to a request
for confidential treatment under Rule 406 of the Securities Act of
1933, as amended. |
|
++ |
|
We agree to furnish supplementally to the Commission a copy of any
omitted schedule or exhibit to this agreement upon request by the
Commission. |
|
# |
|
Management contract or compensatory plan or arrangement. |
57
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized, on March 3, 2008.
|
|
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|
|
ATHEROGENICS, INC.
|
|
|
By: |
/s/RUSSELL M. MEDFORD
|
|
|
|
Russell M. Medford, M.D., Ph.D. |
|
|
|
President and Chief Executive Officer |
|
|
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
|
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Name |
|
Title |
|
Date |
|
|
|
|
|
Principal Executive Officer: |
|
|
|
|
|
|
|
|
|
/s/RUSSELL M. MEDFORD
Russell M. Medford
|
|
President and Chief Executive
Officer, Director
|
|
March 3, 2008 |
|
|
|
|
|
Principal Financial and Principal
Accounting Officer: |
|
|
|
|
|
|
|
|
|
/s/MARK P. COLONNESE
Mark P. Colonnese
|
|
Executive Vice President,
Commercial Operations
and Chief Financial Officer |
|
|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
Michael A. Henos |
|
|
|
|
|
|
|
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|
|
Director
|
|
March 3, 2008 |
R. Wayne Alexander |
|
|
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|
|
|
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|
|
Director
|
|
March 3, 2008 |
Samuel L. Barker |
|
|
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|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
David Bearman |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
Vaughn D. Bryson |
|
|
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|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
T. Forcht Dagi |
|
|
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|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
Margaret E. Grayson |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
Arthur M. Pappas |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
March 3, 2008 |
William A. Scott |
|
|
|
|
|
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|
|
*By:
|
|
/s/JOSEPH M. GAYNOR, JR.
|
|
|
|
|
|
|
|
|
|
Joseph M. Gaynor, Jr. |
|
|
|
|
Attorney-in-Fact |
|
|
58