Form 425
Filed by Celgene Corporation
Pursuant to Rule 425 of the Securities Act of 1933
and deemed filed pursuant to Rule 14a-12
of the Securities Exchange Act of 1934
Subject Company: Abraxis BioScience, Inc.
Commission File No.: 001-33657
The following is an excerpt of the transcript relating to an analyst conference call held on
July 29, 2010 in connection with the announcement by Celgene Corporation (Celgene) of its 2010
second quarter operating and financial results that included certain updates regarding its proposed
acquisition of Abraxis BioScience, Inc. (Abraxis BioScience).
Forward-Looking Statements
This material contains certain forward-looking statements which involve known and unknown risks,
delays, uncertainties and other factors not under Celgenes control. The Celgenes actual results,
performance, or achievements could be materially different from those projected by these
forward-looking statements. The factors that could cause actual results, performance, or
achievements to differ from the forward-looking statements include the risk that the acquisition of
Abraxis BioScience may not be consummated for reasons including that the conditions precedent to
the completion of the acquisition may not be satisfied; the possibility that the expected benefits
from the proposed merger will not be realized, or will not be realized within the anticipated time
period; the risk that Celgenes and Abraxis BioSciences businesses will not be integrated
successfully; the possibility of disruption from the merger making it more difficult to maintain
business and operational relationships; any actions taken by either of the companies, including but
not limited to, restructuring or strategic initiatives (including capital investments or asset
acquisitions or dispositions); and other risks that are discussed in Celgenes filings with the
Securities and Exchange Commission (SEC), such as Celgenes Form 10-K, 10-Q and 8-K reports and
in Abraxis BioSciences filings with the SEC, such as its Form 10-K, 10-Q and 8-K reports. Given
these risks and uncertainties, you are cautioned not to place undue reliance on the forward-looking
statements.
Participants in Solicitations
Celgene, Abraxis Bioscience and their respective directors, executive officers and other members of
their management and employees may be deemed to be participants in the solicitation of proxies from
stockholders of Abraxis Bioscience in connection with the merger. Information regarding Celgenes
directors and officers is available in Celgenes proxy statement on Schedule 14A for its 2010
annual meeting of stockholders and
Celgenes 2009 Annual Report on Form 10-K, which were filed with the SEC on April 30, 2010 and
February 18, 2010, respectively. Information regarding Abraxis Biosciences directors and executive
officers is available in Abraxis Biosciences proxy statement on Schedule 14A for its 2009 annual
meeting of stockholders and Abraxis 2009 Annual Report on Form 10-K, which were filed with the SEC
on October 30, 2009 and March 12, 2010, respectively. Additional information regarding the
interests of such potential participants will be included in the proxy statement and the other
relevant documents filed with the SEC when they become available.
Additional Information about the Transaction and Where to Find It
This material shall not constitute an offer of any securities for sale. The acquisition will be
submitted to Abraxis Biosciences stockholders for their consideration. In connection with the
acquisition, Celgene and Abraxis Bioscience have filed a registration statement on Form S-4 and a
preliminary proxy statement/prospectus with the SEC on July 29, 2010 and intend to file other
relevant materials with the SEC, including amendments and supplements to such registration
statement and preliminary proxy statement/prospectus and other relevant documents concerning the
merger. Investors and stockholders of Celgene and Abraxis Bioscience are urged to read the
registration statement, the proxy statement/prospectus and other relevant documents filed with the
SEC when they become available, as well as any amendments or supplements to the documents because
they will contain important information about Celgene, Abraxis Bioscience and the merger.
Stockholders of Celgene and Abraxis Bioscience can obtain more information about the proposed
transaction by reviewing the Form 8-K to be filed by Celgene and Abraxis Bioscience in connection
with the announcement of the entry into the merger agreement, and any other relevant documents
filed with the SEC when they become available. The registration statement, the proxy
statement/prospectus and any other relevant materials (when they become available), and any other
documents filed by Celgene and Abraxis Bioscience with the SEC, may be obtained free of charge at
the SECs web site at www.sec.gov. In addition, investors and stockholders may obtain free copies
of the documents filed with the SEC by directing a written request to: Celgene Corporation, 86
Morris Avenue, Summit, New Jersey, 07901, Attention: Investor Relations, or Abraxis Bioscience
Inc., 11755 Wilshire Blvd., Los Angeles, CA, 90025, Attention: Investor Relations. Investors and
stockholders are urged to read the registration statement, the proxy statement/prospectus and the
other relevant materials when they become available before making any voting or investment decision
with respect to the merger.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
CORPORATE PARTICIPANTS
Tim Smith
Celgene Corp. Director, IR
Bob Hugin
Celgene Corp. CEO
Dave Gryska
Celgene Corp. CFO
CONFERENCE CALL PARTICIPANTS
Operator
Chris Raymond
Robert W. Baird and Company Analyst
Jason Zhang
BMO Capital Markets Analyst
Geoffrey Porges
Sanford Bernstein Analyst
Howard Liang
Leerink Swann Analyst
Charles Duncan
JMP Securities Analyst
Geoff Meacham
JPMorgan Analyst
Yaron Werber
Citi Analyst
Eric Schmidt
Cowen & Co. Analyst
Mark Schoenebaum
ISI Group Analyst
Rachel McMinn
BofA Merrill Lynch Analyst
Brian Abrahams
Oppenheimer & Co. Analyst
Thomas Wei
Jefferies & Co. Analyst
PRESENTATION
Operator
Good day, ladies and gentlemen. Welcome to the Celgene second quarter earnings call. At this time
all participants are in a listen-only mode. Later we will conduct a question-and-answer session and
instructions will follow at that time. (Operator Instructions) As a reminder, this conference call
is being recorded.
I would now like to turn the conference over to Tim Smith, Director of Investor Relations at
Celgene Corp. Tim.
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1
FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Tim Smith - Celgene Corp. Director, IR
Good morning, everyone, and thank for joining us this morning. I would like to welcome you to
Celgenes Second Quarter conference call. The press release reporting our operating results was
issued earlier this morning and is also available on our corporate website. In addition, todays
conference call webcast will include a presentation which you
can access by going to the Investor Relations section of our website at www.Celgene.com. Joining me
this morning are David Gryska, our Chief Financial Officer, Bob Hugin, our Chief Executive Officer
and Dr. Sol Barer, our Executive Chairman.
Before we start, we want to remind you that our discussions during this conference call will
include forward-looking statements. All such forward-looking statements exclude the effects of the
proposed acquisition of Abraxis Bioscience unless noted. Our actual results, performance or
achievements could be materially different from those projected by these forward-looking
statements. The factors that could cause actual results, performance or achievements to differ from
our forward-looking statements are discussed in our filings with the Securities and Exchange
Commission, such as our Form 10-K, 10-Q and 8-K reports. Given these risks and uncertainties,
youre cautioned not to place undue reliance on our forward-looking statements. Also our
discussions during this conference call will include certain non-GAAP financial measures. Non-GAAP
financial measures provide investors and management with supplemental management of operating
performance and trends that facilitate and comparisons between periods before and after certain
items that would not otherwise be apparent on a GAAP basis.
Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures are
available as part of our earnings releases on Celgenes website at www.Celgene.com in the Investor
Relations section. I will now turn the call over to our Chief Executive Officer Bob Hugin.
Bob Hugin - Celgene Corp. CEO
Thank you. The Second Quarter was outstanding across all functions and geographies. Our exceptional
global teams produced both excellent operating results and achieved multiple significant milestones
that have the potential to create meaningful benefits for patients and strong returns for
shareholders for years to come.
Earlier this morning, we announced record financial results with total revenue growing 36%
year-over-year to $850 million and non-GAAP earnings per share increasing 50% year-over-year to
$0.69.
Before we review the specific operating and financial results of the quarter, I would like to
highlight several of the key strategic developments of the last three months. Though not yet
completed, the announced Abraxis Bioscience acquisition broadens our therapeutic focus into the
solid tumor market. Their lead product Abraxane which is approved for the treatment of metastatic
breast cancer in the United States and international markets has also shown significant promise in
pancreatic and non-call cell lung cancer in clinical trials. The transaction provides the
opportunity for us to leverage our global commercial, clinical and regulatory organizations and
further strengthens our pipeline with multiple candidates from the Abraxis proprietary NAB
technology portfolio. Advancing our hematology pipeline is also a strategic imperative. At the
American Society of Clinical Oncology and European hematology meetings in June, there were many
presentations that highlighted important new data supporting our key products and programs. Perhaps
the most significant data were results from three Phase III studies demonstrating the substantial
benefit achieved by multiple myeloma patients receiving continuous REVLIMID therapy. Our
international expansion strategy continues to be an important growth driver for our products. On
June 25, REVLIMID was approved in Japan for the treatment of second line multiple myeloma.
Governmental reimbursement was achieved in less than a month following approval. Accurately
reflecting the importance of REVLIMID therapy in myeloma and a validation of the quality of the
planning and execution of the Celgene team in Japan.
We are now in the early stages of a thoughtfully planned commercial launch in this, the second
largest oncology market in the world. The investments we have made in Japan and other international
markets will enable us to capture the full value of REVLIMID and the many other opportunities in
our pipeline in all major markets.
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2
FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
During the quarter, substantial progress was achieved in advancing multiple pipeline programs
highlighted by initiation of our first pivotal Phase III trial for our lead anti-inflammatory
product Apremilast in psoriatic arthritis and the initiation of our Phase I cancer clinical study
of our novel dual our kinase inhibitor CC223, a product of our research labs in San Diego. The
significant progress in this quarter further strengthens our belief that sustained long-term growth
comes best through an unwaivering commitment to invest in multiple programs designed to produce
breakthrough therapies for patients with serious unmet medical needs. I would like now to hand the
call over to Dave Gryska, our Chief Financial Officer who will review our Second Quarter financial
results. Dave.
Dave Gryska - Celgene Corp. CFO
Thanks, Bob. Now Ill take you through our record financial results. Non-GAAP total revenue for the
second quarter was $850 million, a 36% increase versus the second quarter of 2009. Non-GAAP net
income for the Second Quarter was $323 million and non-GAAP diluted earnings per share was $0.69.
Total non-GAAP net product sales increased to $821 million for the Second Quarter, up 38% from $596
million in the year ago quarter. Second Quarter REVLIMID net product sales were $587 million, an
increase of 48% over the Second Quarter of 2009. Turning to VIDAZA, net product sales for the
quarter were $132 million, an increase of 43% from the year ago quarter. THALOMID net sales were
$98 million for the quarter down 7% as compared to a year ago quarter.
The Second Quarter sales of REVLIMID in the US were $351 million, representing an increase of 15%
on a sequential quarter basis. And a 44% increase when compared to the Second Quarter of 2009.
International sales were $236 million, representing an increase of 5% on a sequential quarter basis
and a 54% increase when compared to the Second Quarter of 2009.
Our non-GAAP product gross margin for the Second Quarter of 2010 was approximately 92.4%, gross
margins were slightly negatively impacted for the quarter by non-recurring inventory manufacturing
charges. Its important to note that inventory levels were virtually unchanged as compared to the
First Quarter. We continue to expect gross margins to be approximately 93% for the full year.
Turning now to expenses, non-GAAP R&D expense during the Second Quarter was $202 million, an
increase of 9% over the First Quarter of 2010. We are continuing to strategically invest in
developing new products that will enhance our long-term growth, during 2010 our development efforts
will evaluate multiple compounds in more than 20 pivotal and Phase III clinical trials. Our key
development programs are evaluating REVLIMID in all stages of multiple myeloma as well as pivotal
Phase III trials of NHL and CLL. We are also conducting late stage trials for apremilast,
pomalidomide, amrubicin, vidaza, and istodax. In addition, were continuing to advance more than 16
promising compounds in preclinical and early stage development and expect all of these activities
to accelerate in the second half of the year. We now expect non-GAAP R&D expenses to be in a range
of $845 million to $865 million for the full year.
Taking a look at SG&A, non-GAAP selling, general, administrative expenses were $197 million during
the Second Quarter. An increase of approximately 5% from the First Quarter of 2010. We now expect
non-GAAP SG&A expenses to be in a range of $675 million to $785 million for 2010 as we continue our
international commercialization of REVLIMID, VIDAZA and our patient support programs in the US.
Turning to taxes, our non-GAAP tax rate for the Second Quarter was approximately 18%. This
improvement in the tax rate is the result of a one time benefit from a settlement related to state
taxes. We expect the 2010 non-GAAP effective tax rate to improve to approximately 19.5% for the
year.
As you are aware, we hedge our balance sheet foreign currency exposures in our Company foreign
currency transactions and exposure led to certain revenue expenses based on foreign currencies. The
impact of foreign currency on total revenue on a sequential quarter basis was immaterial. We are
well positioned with our hedging programs to minimize the volatility
of various foreign currencies effects on our earnings for the year. In addition, during the Second
Quarter, we realized approximately $5 million hedging and revaluation losses which are included in
other income and expense.
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3
FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
This was an exceptional quarter with record revenue and earnings. We ended the quarter with cash
and marketable securities of approximately $3.1 billion. We repurchased approximately 1.9 million
shares of common stock during the quarter. We are updating our 2010 financial outlook. REVLIMID net
product sales are anticipated to increase to a range of $2.3 billion to $2.35 billion, up from a
previous range of $2.2 billion to $2.3 billion. Total revenue is now expected to increase to a
range of $3.4 billion to $3.45 billion. Up from a previous range of $3.3 billion to $3.4 billion.
This updated revenue guidance does not include Abraxis Bioscience. Non-GAAP diluted earnings per
share are expected to increase to a range of $2.65 to $2.70 as compared to a range of $2.60 to
$2.65 that was previously reported. The updated non-GAAP EPS guidance includes approximately $0.05
dilution from the proposed acquisition of Abraxis Bioscience.
In summary, we continue to execute on the global expansion plan for hematology, oncology and
information franchises. Our business model is driven by strong operating leverage and efficiency as
evidenced by industry leading operating margins. We are truly well positioned to achieve our goals
in 2010 and beyond and continue to deliver record operating results. Now Ill turn the call over to
our Chief Executive Officer Bob Hugin who will give you his further update.
Bob Hugin - Celgene Corp. CEO
Thank you, Dave. Quite a quarter. The operating results of the quarter were highlighted by strong
REVLIMID revenue growth with sales growing 48% year-over-year and 11% over the last quarter. Sales
were up 15% quarter over quarter in the US with 4% sequential growth internationally.
Many factors contributed to this excellent performance, most notably recent data highlighted at
ASH, ASCO, and EHA all supporting continuous REVLIMID therapy. VIDAZA growth accelerated in the
quarter. Year-over-year global sales increased 43% with 10% growth quarter over quarter. Europe was
the primary driver of this growth and international sales now represent greater than 50% of total
sales. In addition to new markets, label expansion has the potential to be a major growth driver
for REVLIMID in multiple indications. At EHA in June operator.
Operator, do you hear music?
Operator
(Technical difficulties.) You may continue.
Bob Hugin - Celgene Corp. CEO
Thank you very much. Lets see.
As I was mentioning, new markets are important to our expansion and growth. Label expansion also
has the potential to be major growth driver for REVLIMID in multiple indications. At EHA in June,
positive updated data from MMO-15 was presented. The Phase III trial in newly diagnosed myeloma
patients will be the backbone of our submission to European regulatory authorities later this year.
As we deliver in our near term value drivers, were also focused on long-term value creation. We
remain committed to maximizing the full potential of REVLIMID worldwide with pivotal studies,
ongoing in lymphoma, CLL, MDS and prostate cancer. Recently we enrolled our first patients in our
Phase III trial PSA 002 for APRENALAX in patients with psoriatic
arthritis. Were optimistic that well be able to close the Abraxis acquisition in the coming 2 to 3 months. We look
forward to updating you on our strategy for capitalizing on the opportunities and synergies of the
combined companies as we clear regulatory hurdles.
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4
FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
The fundamentals in our core myeloma business remain very strong. Growth in the US was driven by
increasing new patient starts and duration gains. Our core European markets also produced robust
results despite an increasingly challenging economic environment. Second line market share
increased to nearly 40% in the four major European markets where REVLIMID is reimbursed. In the
United Kingdom where REVLIMID is reimbursed in third line, market share is over 50%. Were
monitoring the environment closely and believe that our guidance appropriately reflects the current
economic reality.
In other international markets, we also saw strong sequential growth and are making good progress.
The approval in Japan represents the most significant commercial development in the quarter. As I
mentioned earlier, were in the process of initiating a well planned launch in Japan which includes
the introduction of our proprietary risk management system, (inaudible) to nearly 250 sites across
Japan. We believe that our long-term interests are best served by ensuring that hematologists in
Japan are well educated on the effective and safe use of REVLIMID to ensure a positive first
experience. A proper foundation will pay significant long-term dividends.
Physician practice in oncology is data driven. New data is the life blood of hematology oncology
products. In early June, data was presented for more than 100 posters and more than 20 oral
presentations at the ASCO and EHA meetings. By every measure, these meetings were a great success
for Celgene products.
Data from three pivotal studies demonstrated that continuous treatment with REVLIMID for patients
with multiple myeloma has the potential to become the standard of care. In addition, abstracts were
presented that demonstrated REVLIMIDs activity in lymphomas and leukemias and exciting new data
about pomalidomide in relaxed refractory myeloma was also highlighted. Based on these clinical
based on the clinical and commercial potential of these results, we continue to accelerate the
development of these products and indications as rapidly as possible.
We believe that were just seeing the beginning of the impact of the paradigm changing data that
supports continuous use of REVLIMID. In the IFM and CALGB studies presented at ASCO, continuous
REVLIMID therapy demonstrated unprecedented reductions in the risk of disease progression in the
post stem cell transplant setting with 54% and 58% risk reduction respectively. A week later,
updated data that included 70% of events from MMO-15 were presented at EHA and the results were
consistent. A 58% reduced risk of overall progression into non-stem cell transplant population. The
data presented from the podium from MMO-15 and the IFM and CALGB studies all illustrated the
progression free survival advantage of continuous REVLIMID therapy.
The three Phase III studies represent a pillar of our myeloma strategy, the generation of
supportive data for early and continuous treatment of the disease. In addition to MMO-15, IFM and
CALGB studies, other presentations at ASCO presented data demonstrating that REVLIMID combined with
dexamethasone is a highly active induction therapy and that REVLIMID may even represent an
alternative to stem cell transplant in certain patient populations.
Were continuing to develop our clinical strategy for the treatment of high risk smoldering myeloma
while at the same time accelerating the development of Pomalidomide for the treatment of relaxed
refractory myeloma where studies have demonstrated a 50% response rate representing the highest
response rate of any single agent in relaxed refractory disease. Were committed to improving the
treatment options in all lines of therapies for patients with multiple myeloma. Paradigm changing
data, increased market share and duration and global expansion, all of these factors contributed to
the very strong results that were produced this past quarter. As we seek to broaden our label
indication as physicians become more aware of this new data, were optimistic that our strong
performance in this market will continue.
VIDAZA also produced excellent results in the second quarter. International VIDAZA growth was
particularly strong as we continue to establish a leadership position in major European countries
and other key markets. In the United States, revenues were up 3% quarter over quarter, maintaining
market share leadership. VIDAZA remains the only agent in its class worldwide that demonstrates
survival advantage in MDS AML. We have a number of ongoing studies to strengthen VIDAZAs role in
the treatment of MDS and AML. Positive trends continue in the MDS del 5-Q market with REVLIMID.
Were optimistic that well receive regulatory approval in Japan later this year and were on track
for an MDS del 5-Q submission in Europe soon after the MMO-15 myeloma filing in Europe.
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5
FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
The international launch of VIDAZA is ongoing with global expansion and share gains coupled with
increasing duration driving growth. Additional data on both REVLIMID and VIDAZA and MDS is expected
at this years American site of hematology meeting in December. In addition to the outstanding
REVLIMID data and multiple myeloma that was presented at ASCO there were numerous other abstracts
that highlighted the potential of REVLIMID and our broader hematology/oncology pipeline.
Groundbreaking data from a study that evaluated the novel R squared REVLIMID plus RETUXAN
combination of patients with follicular lymphoma demonstrated 97% response rate which included a
complete response rate of 86% with duration now greater than six months. This represents a
significant opportunity for REVLIMID and lymphoma and we expect to begin a pivotal Celgene
sponsored study in the coming months. We also recently initiated an adaptive design study in
patients with diffuse large T-Cell lymphoma. The concept for this study was based upon the
differential response rate data seen in the biomarker defined subset of the patient population. In
addition to these studies, well continue to maximize the potential of REVLIMID in lymphoma with
additional pivotal studies of mantel cell lymphoma and diffuse large B cell lymphoma. In leukemia,
positive data was presented at ASCO that illustrates the potential of our pivotal CLL-008 trial
which is evaluating REVLIMID as a first line therapy in elderly CLL patients.
It in addition to REVLIMID, our hematology/oncology pipeline had seven compounds in all stages of
development. We expect to have results from our pivotal study evaluating if the (inaudible) in
relaxed refractory peripheral T-Cell lymphoma in the next coming few weeks. With approximately 15
pivotal and Phase III trials from the (inaudible) pipeline, there will be a steady flow of
important new data for the next several years leading to what we believe will be another 5 to 10
new indications in this period. I do look forward to our next presentation when we should be able
to add Abraxane and the Abraxis pipeline to this slide.
Speaking of Abraxis, were on track with all of our regulatory filings related to the transaction.
Both companies submitted the required HartScottRodino filings two weeks ago and the S-4 proxy
statement was submitted earlier this morning. Once the filing is declared effective by the SEC
there will be an Abraxis shareholder meeting to approve the transaction. The transaction is
expected to close shortly after that meeting. We do expect theat the transaction will close before
our next conference call in late October and look forward to updating you on our progress and plans
at that time.
In addition to the hematology/oncology discussions, we continue to build a substantial portfolio of
assets in our inflammation and immunology franchise. We now have six candidates in clinical
development. This pipeline was a major focus at our R&D day in April and has continued to make
excellent progress since then. Were not initiating our first trial at ACE-11 in renal anemia
moving rapidly to Phase II in Krohns disease with our cellular therapy PDA-001 and advancing our
JNK inhibitor in idiopathic pulmonary fibrosis. Our most advanced program is Apremilast. In just
the past few weeks, we have dosed our first patients in PSA-002. The first of our pivotal trials.
We have an extensive development program for Apremilast in psoriatic arthritis, moderate to severe
psoriasis, rheumatoid arthritis and other severe immune inflammatory diseases. All of our pivotal
trials in psoriatic arthritis and psoriasis are targeted to be initiated before the end of this
year.
It was an exceptional quarter, both in terms of financial and operating results and also in terms
of positioning Celgene for the future. While producing strong bottom line results, were also
investing the future to sustain the success and high growth that weve achieved. Were executing on
our plan and managing the challenges of healthcare reform in the US and budgetary pressures in the
EU while making the sound strategic decisions to extend our capabilities around the world and to
expand therapeutic franchises that capitalize on our existing strength.
As we close, I want to recognize and thank the Celgene team worldwide who all contributed to these
extraordinary results of this past quarter. Superb results achieved in the challenging global
economy. Its their dedication, their passion for the patient, their creativity and expertise that
makes us so optimistic about the future.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Thank you for joining us this morning. And we look forward to answering your questions. So,
operator, please you can now open the call to questions.
QUESTIONS AND ANSWERS
Operator
Thank you. (Operator Instructions) Our first question is from Chris Raymond of Robert Baird and
Company. Your line is open.
Chris Raymond - Robert W. Baird and Company Analyst
Thanks for taking the question. Just curious on the new REVLIMID revenue guidance. Just kind of
doing the math quarter on quarter, even at the top end of the guidance, I know its still early
days here in terms of looking at the second half, but if you do the math, there is an implied
decrease in quarter on quarter growth. And Im wondering if there is something specific that we
should be thinking about or if its just a level of conservativism in that number. Thanks.
Bob Hugin - Celgene Corp. CEO
No. Its a good question, Chris. Clearly we wanted to raise the guidance. We think the results of
the quarter were very, very strong. I think we do need to be careful that there could be summer
seasonality in some markets. There clearly are some budgetary pressures in Europe. Were managing
them quite well so far and I think our own outlook is that well continue to do that in an
effective manner. So I think its just appropriate that were here with uncertainty in the
marketplace. We certainly wanted to increase the guidance.
Its the Second Quarter in a row. So the guidance for the year at the beginning of the year has
turned out so far to be fairly conservative. And so I think there isnt anything out there that
were seeing that other people arent seeing. The trends are very positive. Were optimistic about
the future. But I think we didnt want to raise the guidance. We didnt think it was appropriate to
do so. I think you do reflect that there is hopefully better opportunities than guidance indicates,
but we do want to be cautious with the environment that were facing. But there isnt anything we
know thats not out there.
Chris Raymond - Robert W. Baird and Company Analyst
Thank you.
Operator
Thank you. Our next question is from Jason Zhang of BMO Capital Markets. You may ask your question.
Jason Zhang - BMO Capital Markets Analyst
Hi. Thanks. Good quarter. Bob, have you provided us the average duration of REVLIMID in the US
versus the European countries and also if you could share with us your current rate of the market
share with regard to REVLIMID or REVLIMID together with Pomalidomide in a multiple myeloma market.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Bob Hugin - Celgene Corp. CEO
Yes, the market share combined is about 65% overall in the US when you put our products across the
lines in myeloma, which has continued to be very strong and clearly REVLIMID being the most widely
prescribed drug in the US and Pomalidomide moving more towards second, third and fourth line
therapy over time. In terms of duration, weve made the decision for competitive reasons to ensure
that we retain the full negotiating leverage in all of the markets that we seek reimbursement, et
cetera. So we just we dont think it makes sense for us to give specific duration information
out. I think on the core of the trends in the US were positive on duration and we saw positive
duration trends in the major developed markets outside of the United States. So continuation of a
very positive trend, but the specifics are things that we just dont think is in our interest to
publicly give out any longer.
Jason Zhang - BMO Capital Markets Analyst
In the past, if I could just follow up on that, we have seen in a half a month duration increase
per quarter. At some point were going to see that slowing down. But you said still positive, still
increasing. Are we still in the same ballpark as half a month increase per quarter or is it a
little different than what we have seen in the past?
Bob Hugin - Celgene Corp. CEO
I think the trends continue to be quite consistent with what we have seen in the past. The IFM
CALGB data were only presented in June. So if we were to see an acceleration of that trend, it
would be early to see that. But so far what we saw in the Second Quarter was consistent with the
very positive trends weve seen before that.
Jason Zhang - BMO Capital Markets Analyst
Okay. Thanks.
Operator
Thank you. Our next question is from Geoffrey Porges of Bernstein. Your line is open.
Geoffrey Porges - Sanford Bernstein Analyst
Thank you very much. Congratulations. Great quarter. Just a couple of questions. First, youve got
a lot of studies where you have a primary input of PFF. Could you comment on your interpretations
or the significance of the FDA, advisory committees discussion of the PFF signal for AVASTIN in
breast cancer and whether that changes your expectations? And then just following up on that, you
seem to imply that your filing in Europe is just going to be MMO-15. Is that correct or will you
still be including JLGB-IFM data and then some of the other corporate group studies as well?
Thanks.
Bob Hugin - Celgene Corp. CEO
First, on the latter question about the European filing, no, certainly MMO-15 will be the backbone
of the filing. But we intend to include in that filing as much data and we have so many successful
Phase III trials supporting newly diagnosed and maintenance therapy for REVLIMID. So we will we
will be including multiple trials in that package to ensure the most robust data package and the
most robust label as possible in that review process. So there is no change to that. If anything,
were more convinced to ensure that we have all of that data included in there. And the time line
is unchanged to get that done before the end of this year.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
On the first question about PFF data, et cetera, I do think it is always important to ensure
that youve got a close dialogue with regulatory agencies regarding end points of clinical trials,
and we certainly would not pursue regulatory strategies without a good intensive of robust
discussion with regulatory authorities in advance of initiating those trials. And I think the
specifics I think you have to be careful of extrapolating one market segment to another. It very
much depends on what therapies are available out there and what is available to be explored and
examined in clinical trials in a particular patient setting. So I think that its, again, always
instructive to learn and listen. But we feel good about the direction that were headed and were
engaged in a very robust discussion to ensure that our clinical trials meet the kind of criteria
that are going to be important for both regulatory and reimbursement for positive outcomes upon
successful completion of the trial. So I think we feel that our segments and our market indications
are very well understood and I think were targeting the right end points.
Operator
Thank you. Our next question is from Howard Liang of Leerink Swann. Your line is open.
Howard Liang - Leerink Swann Analyst
Thanks very much. Regarding the development plan for R squared, the pivotal trial for lymphoma that
you highlighted, is this going to be a Phase III trial or is that similar to what you were
outlining at the R&D data which is Pomalidomide Phase II?
Bob Hugin - Celgene Corp. CEO
We will in the relatively near term be able to give you a little bit more clarity. We are in the
process of finalizing regulatory discussions as exactly what will be required in both the design
and the the design of the trial in multiple markets. So the data is very, very positive. It
really encourages especially when you look at the duration of those very, very strong responses.
Its a subject of a pretty robust discussion right now with regulatory agencies. So as soon as we
have clarity and we begin to initiate those trials, well give you full disclosure on what that
design is.
Howard Liang - Leerink Swann Analyst
Thanks.
Operator
Thank you. Our next question is from Charles Duncan of JMP Securities. Your line is open.
Charles Duncan - JMP Securities Analyst
Hi, guys. Thanks for taking the question. Let me ask add my congratulations on a very good
quarter. Bob, with regard to the Japanese commercial rollout, you mentioned RevMate. Could you tell
us how that is different, if it is, from RevAssist in terms of the cost or the adoption curve
impact that it may have? How is that really a different risk mitigation system?
Bob Hugin - Celgene Corp. CEO
Well, the RevMate system in Japan is clearly consistent with our very strong global philosophy of
ensuring that REVLIMID is appropriately distributed in each individual market. And then markets
clearly have differentiating characteristics. Japan is a market with a very, very significant
sensitivity to past effects of drugs with birth defects. And overall a market very sensitive to
side effect management. And so that were very were being, I think, very prudent here to
ensure that weve got the right risk management system. Its something weve developed and our team has developed in very
strong concert with important other constituencies in Japan, including the ministry and patient
groups, et cetera. So its been thoughtfully done. Its well planned out. We do not think you will
have any long-term negative impediment. Well get people confidence that its a very safe system
and its going to be well-controlled and managed.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
That being said, putting the risk management system aside, Japan is a great market. And REVLIMID is
a spectacularly well situated compound that fits extraordinarily well with conditions and market of
Japan. An oral therapy with very manageable side effects. With strong effectiveness demonstrated in
the label indication. So its very important for us to establish Japan early on and make sure that
physicians are very comfortable with how they administer the drug, how to safely do it, how to
manage the side effects. And thats a marketplace if you establish a strong initial presence and
physicians are comfortable with how they use a drug with initial 1, 2, 3, patients, youre going to
see a very rapid uptake over the longer term. But in the near term we thought the reason were
talking about it, we want to make sure people dont get overly enthusiastic to see a dramatic ramp.
Were playing Japan and were positioning ourself for very strong long-term excellent performance,
but were going to do it the right way to ensure education is there, good solid risk management
systems so that physicians, patients and the government and we are all comfortable that its being
done in a very prudent manner. And thats not to say that were arent just incredibly excited
about having the approval on June 25, and to get pricing and reimbursement in such a short period
of time really does reflect I think a few things. One, the importance of a new therapy for myeloma
in Japan. The need for REVLIMID to get out to patients and also I think really the execution, the
planning, the strategy of our Celgene team in Japan to produce that in such a short period of time,
so were very excited but were going to do it in the best way to position for long-term success.
Operator
Our next question comes from Geoff Meacham of JPMorgan. Your line is open.
Geoff Meacham - JPMorgan Analyst
Hey, guys. Congrats on a good quarter. What can you tell us about the IMF guidelines for
maintenance and what impact the data or guidelines could have on European first line or maintenance
used prior to former approval and I have a follow-up?
Bob Hugin - Celgene Corp. CEO
Yes. I think its still early to tell that how rapid and what markets specifically were going
to see the impact from the IFM and CALGB data. But theres no doubt when we look at our medical
information resources theres a strong interest in understanding and learning about the data from
many markets around the world. I do think in some markets well be successful like the US that
people will understand the data and hopefully relatively rapidly use it appropriately to where the
physician thinks its appropriate to use. Certainly its had an impact already in maybe dispelling
some physicians reluctant to treat only to first response and not to treat through to progression.
So I think there is a strong positive impact about continuous therapy from MMO-15, IFM and CALGB in
all sectors in myeloma that we have begun to see over the first half of the year. I think
specifically to the post transplant maintenance setting it will be market to market and I think
its a little bit early for us to have a strong view as to how and what that uptake will be. You
have a follow-up, Jeff?
Operator
Our next question is from Yaron Werber of Citi. Your line is open.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Yaron Werber - Citi Analyst
Hey, guys. I have two questions. One, can you give us a little bit of a sense of what the impact of
healthcare reform was in the quarter? If I recall, it was about negative $4 million last quarter.
Im just trying to get a sense there. And then also, I dont know if you can, but help us
understand a little bit how all the price concessions in Europe will impact your business as we
look to next year?
Dave Gryska - Celgene Corp. CFO
Yaron, its Dave. Ill answer the first part and then Bob will take the second part. The impact on
healthcare reform was between in Q2 between $9 million to $10 million and thats the same kind
of estimate that we gave you last quarter. The revenue impact.
Bob Hugin - Celgene Corp. CEO
And then in Europe, the one impact we had in this past quarter was the 4% price rebate increased
rebate in Spain for orphan drugs, 7.5% for other therapy. We were the 4% level starting June 1, of
a rebate in Spain. That was the only meaningful event in the Second Quarter. Clearly people are
focused on Germany for later this year with an increase of a 10% increase in the rebate in
Germany and the specifics of that are still being finalized. But that looks pretty clear.
Yaron Werber - Citi Analyst
As we look out past 2010, our marketplaces are we look at it country by country. And clearly
there is lots of pressure. I think the impact is more just on budgetary pressures, less on specific
price declines. But were going to see continued price declines and thats the reason why when we
started REVLIMID internationally we established the benchmark price that we did. And so our
original forecast we were expecting to see pressure just in normal course of events in 2011. So in
some respects, were not going to be as dramatically hit by if there are other price increases.
As we look out, its a little early for us to get too granular and specific about 2011. But our
outlook this far in advance using all of the information we have and the outlook for pressures in
Europe is pretty consistent with what we have seen that our expectation is in line with our plan
what we think the growth of REVLIMID will be over the next five years. So, again, these are tough
times out there. But our team in each individual market I think are crafting a very unique and
specific strategy to the markets. It is part of our strategy. We have got to manage price and
duration over time. And it is nothing unusual in terms of what were expecting and were ready to
manage the circumstances, though it certainly is a challenging environment. But we think 2011
initially looks pretty encouraging to us.
Operator
Thank you. And our next question is from Eric Schmidt of Cowen & Co.
Eric Schmidt - Cowen & Co. Analyst
Im wondering if you could talk a little bit about accelerating US trends on REVLIMID quarter on
quarter and maybe also comment on some of the deceleration and ex US growth? So a little bit more
on the geographic split there. And then, Dave, I was a little bit confused as to what is in the
2010 guidance vis-a-vis Abraxis. Do I understand that your SG&A and R&D guidance include expenses
assuming the merger closes in the second half but that any Abraxane revenues are excluded?
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Dave Gryska - Celgene Corp. CFO
So well answer the latter part of your question first, Eric. In our guidance, our revenue guidance
and our SG&A and our R&D does not include Abraxis Bioscience. Okay. That is just Celgene
standalone. And although we did estimate that assuming a transaction close as Bob said the next 2
to 3 months that there would be a $0.05 dilution. So, again, to
be clear, the R&D and SG&A is Celgene standalone. Total revenues are Celgene standalone. Its
pretty difficult for us to get to the granularity before we close on those expenses for Abraxis but
weve given you at least what the dilution would be in terms of the whole year in terms of updating
our guidance on EPS. Any more questions on that?
Bob Hugin - Celgene Corp. CEO
And on the REVLIMID growth trajectory, certainly the US benefited from both an increasing number of
new patients which is very encouraging for the long-term because the quarter was also positively
impacted by increased duration. So as you have a very strong ramp of new patients and you have
increasing duration, that bodes well for the future. So we always have to work very hard to ensure
we have the best strategy and results in the US, but the trends are very positive there.
In Europe the underlying trends were very strong also on a comparative basis and market-to-market.
There were some countries where growth was a little bit slower than it has been where there have
been pressure on budgets, not specifically price cuts, but just authorities, hospital leaders
saying, listen, where can we cut costs just to produce some fiscal restraint. Thats our bigger
issue that as economies need to come to grips with the fiscal challenges they have were going to
have to make sure that the value proposition Celgene is very, very clearly delineated. Thats one
of the great successes of REVLIMID that we have such a great value proposition and why it is
continues to grow in all markets. And we saw in some markets accelerating growth. The UK, Canada
were both very strong in the quarter. So I think were going to continue to see some markets where
were going to see budgetary pressures, others where the duration and increasing market shares will
offset that. So overall we feel very good about what is happening in Europe and the growth there
will continue to be very strong over the next two years.
Operator
Thank you. Our next question is from Mark Schoenebaum of ISI Group. Your line is open.
Mark Schoenebaum - ISI Group Analyst
Hey, guys. Sorry. Thanks for taking my question . I appreciate it. Maybe a little bit of a bigger
picture question for Bob, if I may. So youve done the ABII deal and the Gloucester deal and the
Pharmion deal all M&A and all and oncology. I was just wondering what the Company is currently
thinking regarding business development/M&A outside of oncology?
Bob Hugin - Celgene Corp. CEO
Well, we are clearly very excited about the potential of our immune inflammatory franchise the
Apremilast and the Phase III program, the JNK program, the acceleration of PDA-001 in multiple
indications and aggressively going forward in Krohns. So we think its a great franchise for us.
But right now our focus has to be to closing the Abraxis transaction, ensuring that we execute a
very, very positive integration that we maximize the opportunities that Abraxis brings to us. Both
in terms of fully reaching the potential for Abraxane, both in its approved indications and
ensuring that we get label expansion to the full potential of whats available to us. And we also
think the mass technology portfolio has a number of other candidates in there that we think will
stack up well and well look to develop those also, and well look for other compounds to use in
that technology to develop.
So were going to focus on the synergies of it, but also the growth opportunities of Abraxis. So I
think for the near term were going to continue to execute what we have on our plate. But I do
think the potential of the immuno inflammatory franchise is such a great one and the trajectory is a very positive one and once we have the Abraxis
transaction closed we dont need to do a deal or anything else, wed look at things but certainly
thats not going to happen in the near term here.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Operator
Thank you. Our next question is from Rachel McMinn of BofA Merrill Lynch. Your line is open.
Rachel McMinn - BofA Merrill Lynch Analyst
Thanks very much. Two questions. Just one in Europe you talked about your filing strategy. Have you
actually met with the EMEA recently to discuss the ON-5 data and your filing strategy? And then the
second question is just on healthcare reform. Do you have any updated view for 2011? You had given
guidance earlier in the year and just wanted to see if there were any changes to your thinking on
that front? Thanks.
Bob Hugin - Celgene Corp. CEO
Yes. First, just on the healthcare front, we are just maintaining the guidance that we previously
given of the $80 million to $90 million potential revenue impact in 2011. I do think as the fall
approaches, we will have more clarity on that. And if that guidance should be lowered in terms of
having a less of effect next year or more of an effect, well update you. But right now we do think
the guidance is still from all of the information we have in terms of US revenue impact on US
healthcare reform we wouldnt change that guidance. We have no information now that would lead us
to do that.
And in Europe, Im not going to go into the specifics of it, but we have a very active dialogue
with multiple officials in different countries that well be involved in shepherding the REVLIMID
newly diagnosed application through the European process. So thats an ongoing and very active
dialogue and were on track for submitting that filing by the end of the year.
Operator
Thank you. Our next question is from Brian Abrahams of Oppenheimer. Your line is open.
Brian Abrahams - Oppenheimer & Co. Analyst
Hi. Thanks for taking my question and congrats. My congrats as well on the strong quarter. When we
saw the ON-5 update at EHA, it looked like REVLIMID was continuing to perform well. Looking at the
PFF benefits were a bit more pronounced in the younger patients who were in the trial. So just
wondering how you foresee this potentially impacting the positioning of the RNP plus R regimen and
whether you expect there to be any age recommendations on a front line label? Thanks.
Bob Hugin - Celgene Corp. CEO
Its a little premature to speculate on what exactly will come out of the label in the discussions
with the regulatory agencies. Certainly Prednisone is not a high growth regimen generally in the
myeloma population. So I think our own strategy of doing MMO-20 which is our big largest Phase III
trial in the myeloma marketplace which really examines REVLIMID and dexamethasone versus a
Melphalan-based Pomalidomide regimen is really designed to say, listen, if we are able to get the
broadest label possible and all of the data presented from all the clinical trials that were
hopeful that physicians will have the full course of options to say which specific patient would
benefit best from REVLIMID dexamethasone, which patient would benefit most from Melphalan
Prednisone and REVLIMID or other therapies. I think were getting a good range of data from
multiple clinical trials, Phase III trials. Certainly the REVLIMID ones have all had positive,
positive results. And were optimistic that in the next year or two as we
get the MMO-20 data well have even more information to give physicians, more guidance as to
what is best for newly diagnosed myeloma patients. Were very encouraged by what MMO-15 has had
an impact already in the marketplace, were optimistic the impact it will have in the regulatory
our regulatory ability to expand the label. But MPR is not the will not be as any
Melphalan-based regimen will not be for every single patient.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
Brian Abrahams - Oppenheimer & Co. Analyst
Thanks very much.
Operator
Thank you. And our final question comes from Thomas Wei of Jefferies & Co. Your line is open.
Thomas Wei - Jefferies & Co. Analyst
Thanks. Just a couple of questions. One, just to clarify the commentary on Japan, it sounds like we
should expect that maybe longer term penetration could be as robust as some of your other
territories but maybe the time frame to achieve that more extended relative to the experience with
REVLIMID in the US and Europe. And then also just wanted to get an update on Pomalidomide. The next
round of data on the post REVLIMID Valcade myeloma setting and the potential for you to file in a
more accelerated fashion for that indication. Thanks.
Bob Hugin - Celgene Corp. CEO
Yes. First on Japan, I think you represented it very accurately. Were very, very optimistic about
the potential of REVLIMID and myeloma in Japan and for all of the reasons that we discussed and
hopefully you will keep your estimates as low as possible in the near term for us. But seriously,
we think that success is as important to do it properly with a strong education emphasis and Im
sure that people have a good positive experience because the potential for Japan is such an
important market to us over the next few years, we want to do it right and do it with the right
trajectory. But were very optimistic about what the potential is there. And I think since our last
call the or certainly since the last quarterly conference call the very important Phase II
Pomalidomide trial is very rapidly finished accruing and were going to hopefully look forward to
that data as soon as it is available and theres a potential in the next three or four quarters
well see that data, and that well initiate the Phase III trial in Pomalidomide by the end of the
year. So I have to tell you when we think about priorities here, as we think about the rest of this
year and 2011 the acceleration of Pomalidomide and making that available to the relaxed refractory
myeloma population and the myelo fibrosis population, patient population is a critical corporate
objective because it remains in that last refractory population a serious unmet medical need and an
indication that we feel so strongly about the need to serve myeloma patients. So were very
encouraged by what were seeing, the results, well, soon as we get the Phase II results well share
them and see how they can be used and well accelerate the Phase III trial and were accruing the
pivotal trial in myelo fibrosis. So it really is hard to imagine a higher priority for us than the
acceleration of Pomalidomide development.
I want to thank everybody for joining us this morning and updating getting updated on the
Celgene story and participating with questions. We very much look forward to updating you through
press releases as to the Abraxis transaction, the completion of that and look forward to updating
you on our strategies and progress at our conference call for the end of the third quarter and late
October. Thank you very much.
Operator
Ladies and gentlemen, thank you for participating in todays conference. This concludes the
program. You may now disconnect. Good day.
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FINAL TRANSCRIPT
Jul. 29. 2010 / 1:00PM, CELG Q2 2010 Celgene Corp. Earnings Conference Call
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