UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2014
¨ | 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 001-08568
IGI Laboratories, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 01-0355758 |
(State or other Jurisdiction of | (I.R.S. Employer Identification No.) |
|
|
105 Lincoln Avenue |
|
(Address of Principal Executive Offices) | (Zip Code) |
(856) 697-1441
(Registrants telephone number, including area code)
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 ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes þ No ¨
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.
Large accelerated filer | ¨ |
| Accelerated filer | ¨ |
Non-accelerated filer | ¨ |
| Smaller reporting company | þ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ¨ No þ
The number of shares outstanding of the issuer’s common stock is 47,122,121 shares, net of treasury stock, as of May 10, 2014.
PART I
FINANCIAL INFORMATION
ITEM 1.
Financial Statements
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except shares and per share information)
(Unaudited)
| Three Months Ended | ||
| 2014 |
| 2013 |
Revenues: |
|
|
|
Product sales, net | $ 6,383 |
| $ 3,467 |
Research and development income | 313 |
| 159 |
Licensing, royalty and other revenue | 157 |
| 57 |
Total revenues | 6,853 |
| 3,683 |
|
|
|
|
Costs and Expenses: |
|
|
|
Cost of sales | 3,987 |
| 2,575 |
Selling, general and administrative expenses | 1,282 |
| 679 |
Product development and research expenses | 1,365 |
| 658 |
Total costs and expenses | 6,634 |
| 3,912 |
Operating income (loss) | 219 |
| (229) |
Interest expense and other, net | (52) |
| (28) |
|
|
|
|
Net Income (Loss) | $ 167 |
| $ (257) |
|
|
|
|
Basic income (loss) per share | $0.00 |
| $(0.01) |
Diluted income (loss) per share | $0.00 |
| $(0.01) |
|
|
|
|
Weighted average shares of common stock outstanding: |
|
|
|
Basic | 46,826,733 |
| 42,933,146 |
Diluted | 48,529,603 |
| 42,933,146 |
The accompanying notes are an integral part of the condensed consolidated financial statements.
2
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share information)
| (Unaudited) |
| December 31, | ||
ASSETS |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents | $ | 2,414 |
| $ | 2,101 |
Accounts receivable, net |
| 4,120 |
|
| 4,947 |
Inventories |
| 2,661 |
|
| 2,869 |
Prepaid expenses and other receivables |
| 691 |
|
| 641 |
Total current assets |
| 9,886 |
|
| 10,558 |
Property, plant and equipment, net |
| 2,598 |
|
| 2,623 |
Product acquisition costs |
| 1,736 |
|
| 1,766 |
Restricted cash, long term |
| 54 |
|
| 54 |
License fee, net |
| 175 |
|
| 200 |
Debt issuance costs, net |
| 61 |
|
| 69 |
Other |
| 157 |
|
| 157 |
Total assets | $ | 14,667 |
| $ | 15,427 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable | $ | 1,339 |
| $ | 1,523 |
Accrued expenses |
| 2,004 |
|
| 2,915 |
Deferred income, current |
| 360 |
|
| 768 |
Capital lease obligation, current |
| 11 |
|
| 15 |
Total current liabilities |
| 3,714 |
|
| 5,221 |
|
|
|
|
|
|
Note payable, bank |
| 3,000 |
|
| 3,000 |
Other long term liabilities |
| 12 |
|
| 15 |
Total liabilities |
| 6,726 |
|
| 8,236 |
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
Common stock, $0.01 par value, 60,000,000 shares authorized; 47,019,121 |
|
|
|
|
|
and 46,748,575 shares issued and outstanding as of March 31, 2014 and |
|
|
|
|
|
December 31, 2013, respectively |
| 490 |
|
| 487 |
Additional paid-in capital |
| 52,121 |
|
| 51,541 |
Accumulated deficit |
| (44,670) |
|
| (44,837) |
Total stockholders equity |
| 7,941 |
|
| 7,191 |
Total liabilities and stockholders equity | $ | 14,667 |
| $ | 15,427 |
*Derived from the audited December 31, 2013 financial statements
The accompanying notes are an integral part of the condensed consolidated financial statements.
3
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(Unaudited)
| Three Months Ended | ||||
| 2014 |
| 2013 | ||
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
|
Net income (loss) | $ | 167 |
| $ | (257) |
Reconciliation of net income (loss) to net cash provided by |
|
|
|
|
|
Depreciation |
| 93 |
|
| 94 |
Amortization of license fee |
| 25 |
|
| 25 |
Stock-based compensation expense |
| 259 |
|
| 57 |
Provision for write down of inventory |
| 14 |
|
| 12 |
Amortization of debt issuance costs |
| 8 |
|
| 8 |
Amortization of product acquisition costs |
| 30 |
|
| - |
Changes in operating assets and liabilities: |
|
|
|
|
|
Accounts receivable |
| 827 |
|
| (1,546) |
Inventories |
| 194 |
|
| (279) |
Prepaid expenses and other current assets |
| (50) |
|
| (211) |
Accounts payable and accrued expenses |
| (1,095) |
|
| 426 |
Deferred income |
| (409) |
|
| 77 |
Net cash provided by (used in) operating activities |
| 63 |
|
| (1,594) |
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
Capital expenditures |
| (68) |
|
| (60) |
Product acquisition costs |
| - |
|
| (1,426) |
Net cash used in investing activities |
| (68) |
|
| (1,486) |
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
Proceeds from note payable, bank |
| - |
|
| 1,000 |
Principal payments on capital lease obligation |
| (6) |
|
| (4) |
Costs related to stock issuance |
| (3) |
|
| (42) |
Proceeds from exercise of common stock warrants |
| 327 |
|
| 236 |
Net cash provided by financing activities |
| 318 |
|
| 1,190 |
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
| 313 |
|
| (1,890) |
Cash and cash equivalents at beginning of period |
| 2,101 |
|
| 2,536 |
Cash and cash equivalents at end of period | $ | 2,414 |
| $ | 646 |
|
|
|
|
|
|
Supplemental cash flow information: |
|
|
|
|
|
Cash payments for interest |
| 54 |
|
| 9 |
Cash payment for taxes |
| 7 |
|
| 8 |
The accompanying notes are an integral part of the condensed consolidated financial statements.
4
IGI LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS EQUITY
For the three months ended March 31, 2014
(in thousands, except share information)
|
| Common Stock |
| Additional |
| Accumulated |
| Total Equity | ||
|
| Shares |
| Amount |
| |||||
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2013 |
| 46,748,575 |
| $ 487 |
| $ 51,541 |
| $ (44,837) |
| $ 7,191 |
|
|
|
|
|
|
|
|
|
|
|
Stock based compensation expense stock options |
|
|
|
|
| 75 |
|
|
| 75 |
Stock based compensation expense restricted stock |
|
|
|
|
| 184 |
|
|
| 184 |
Stock warrants exercised |
| 270,546 |
| 3 |
| 324 |
|
|
| 327 |
Costs related to stock issuance |
|
|
|
|
| (3) |
|
|
| (3) |
Net income |
| - |
| - |
| - |
| 167 |
| 167 |
|
|
|
|
|
|
|
|
|
|
|
Balance, March 31, 2014 |
| 47,019,121 |
| $ 490 |
| $ 52,121 |
| $ (44,670) |
| $ 7,941 |
The accompanying notes are an integral part of the condensed consolidated financial statements.
5
IGI LABORATORIES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements included in the Companys Annual Report on Form 10-K for the year ended December 31, 2013. The condensed consolidated balance sheet as of December 31, 2013 has been derived from those audited consolidated financial statements. Operating results for the three month period ended March 31, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014.
1. | Organization | |
|
| |
| IGI Laboratories, Inc. is a Delaware corporation incorporated in 1977. On May 7, 2008, the stockholders of IGI, Inc. approved the name change of the Company from IGI, Inc. to IGI Laboratories, Inc. The Companys office, laboratories and manufacturing facilities are located at 105 Lincoln Avenue, Buena, New Jersey. The Company is a developer, manufacturer, and marketer of topical formulations. The Companys goal is to become a leader in the generic topical pharmaceutical market. In its own label, the Company sells generic topical pharmaceutical products that are bioequivalent to their brand name counterparts. The Company also provides development, formulation, and manufacturing services to the pharmaceutical, over-the-counter (OTC), and cosmetic markets. | |
|
| |
| Currently, we have two platforms for growth: | |
|
| |
| | Manufacturing, developing, and marketing a portfolio of generic pharmaceutical products in our own label in topical dosage forms; and, |
| | Increasing our current contract manufacturing and formulation services business. |
|
|
|
| In addition, we will continue to explore ways to accelerate our growth through the creation of unique opportunities from the acquisition of additional intellectual property, and the expansion of the use of our existing intellectual property, including our licensed Novasome® technology. | |
|
| |
| To date, we have filed fourteen Abbreviated New Drug Applications, or ANDAs, with the United States Food and Drug Administration, or FDA for additional pharmaceutical products. We expect to continue to expand our presence in the generic topical pharmaceutical market through the filing of additional ANDAs with the FDA and the subsequent launch of products as these applications are approved. Our target is to file at least ten ANDAs in 2014 through our internal research and development program. On March 12, 2014, the Company received our first approval from the FDA for an ANDA. The FDA has approved IGIs application for lidocaine hydrochloride USP 4% topical solution. We will also seek to license or acquire further products, intellectual property, or ANDAs to expand our portfolio. On February 1, 2013, we acquired assets and intellectual property, including an ANDA, for econazole nitrate cream 1%, which we launched in September 2013. | |
|
| |
| IGI also develops, manufactures, fills, and packages topical semi-solid and liquid products for branded and generic pharmaceutical customers as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema. |
6
2. | Liquidity |
|
|
| The Companys principal sources of liquidity are cash and cash equivalents of approximately $2,414,000 at March 31, 2014, the $2,000,000 available under the $5,000,000 credit facility detailed below and cash from operations. The Company had net income of $167,000 for the three months ended March 31, 2014 and a net loss of $257,000 for the three months ended March 31, 2013, and had working capital of $6,172,000 at March 31, 2014. |
|
|
| The Companys business operations have been primarily funded over the past five years through private placements of its capital stock. The Company raised an aggregate of $2,000,000 through private placements of equity with accredited investors in 2012, $7,213,000 in 2010 and $5,304,000 in 2009 principally from private equity investors. The use of proceeds was intended for general working capital needs as well as the acquisition of econazole nitrate cream 1% which was purchased on February 1, 2013 and launched in September 2013. In August 2012, the Company also entered into a $3,000,000 line of credit. On July 26, 2013, the Company entered into an amendment to the loan and security agreement. The amendment increased the line of credit to $5,000,000 on December 31, 2013 upon the Companys compliance with certain covenants (See Note 8). As of March 31, 2014 the outstanding balance on the line of credit was $3,000,000. The Company may require additional funding and this funding will depend, in part, on the timing and structure of potential business arrangements. If necessary, the Company may continue to seek to raise additional capital through the sale of its equity or through a strategic alliance with a third party. There may also be additional acquisition and growth opportunities that may require external financing. There can be no assurance that such financing will be available on terms acceptable to the Company, or at all. The Company also has the ability to defer certain product development and other programs, if necessary. The Company believes that our existing capital resources will be sufficient to support its current business plan and operations beyond May 2015. |
|
|
3. | Summary of Significant Accounting Policies |
|
|
| Use of Estimates |
|
|
| The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates include allowances for excess and obsolete inventories, allowances for sales returns, allowances for doubtful accounts, provisions for income taxes and related deferred tax asset valuation allowance, stock based compensation, and accruals for environmental cleanup and remediation costs. Actual results could differ from those estimates. |
|
|
| Income (Loss) Per Share |
|
|
| Basic net income (loss) per share of common stock is computed based on the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share of common stock is computed using the weighted average number of shares of common stock and potential dilutive common stock equivalents outstanding during the period. Due to the net loss for the three months ended March 31, 2013, the effect of the Companys potential dilutive common stock equivalents was anti-dilutive for that period; as a result, the basic and diluted weighted average number of common shares outstanding and net loss per common share are the same. Potentially dilutive common stock equivalents include options and warrants to purchase the Companys common stock and the conversion of preferred stock, which were excluded from the net loss per share calculation for the three months ended March 31, 2013 due to their anti-dilutive effect, and amounted to 6,160,610. |
|
|
| Revenue Recognition |
|
|
| The Company considers revenue realized or realizable and earned when it has persuasive evidence of an arrangement, delivery has occurred or contractual services rendered, the sales price is fixed or determinable, and collection is reasonably assured in conformity with ASC 605, Revenue Recognition. |
7
8
| Accounts receivable are presented net of SRA balances of $1.5 million and $0.8 million at March 31, 2014 and 2013, respectively. Accounts payable and accrued expenses include $0.2 million and $0.3 million at March 31, 2014 and 2013, respectively, for certain fees related to services provided by the wholesalers. Wholesale fees of $0.2 million and $0.3 for the three month periods ended March 31, 2013 and 2012, respectively, were included in cost of goods sold. In addition, in connection with three of the four products the Company currently manufactures, markets and distributes in its own label, in accordance with an agreement entered into in December of 2011, the Company is required to pay a royalty calculated based on net sales to one of its pharmaceutical partners. The royalty is calculated based on contracted terms of 40% of net sales for the three products which is to be paid quarterly to the pharmaceutical partner. In accordance with the agreement, net sales excludes fees related to services provided by the wholesalers. Accounts payable and accrued expenses include $0.9 million and $0.5 at March 31, 2014 and 2013, respectively, related to these royalties. Royalty expense of $1.3 million and $0.5 was included in cost of goods sold for the three months ended March 31, 2014 and 2013, respectively. The Company includes significant estimates to arrive at net product sales arising from wholesaler chargebacks, Medicaid and Medicare rebates, allowances and other pricing and promotional programs. |
|
|
| Contract Manufacturing Sales: The Company recognizes revenue when title transfers to its customers, which is generally upon shipment of products. These shipments are made in accordance with sales commitments and related sales orders entered into with customers either verbally or in written form. The revenues associated with these transactions, net of appropriate cash discounts, product returns and sales reserves, are recorded upon shipment of the products. |
|
|
| Research and Development Income: The Company establishes agreed upon product development agreements with its customers to perform product development services. Product development revenues are recognized in accordance with the product development agreement upon the completion of the phases of development and when the Company has no future performance obligations relating to that phase of development. Revenue recognition requires the Company to assess progress against contracted obligations to assure completion of each stage. These payments are generally non-refundable and are reported as deferred until they are recognizable as revenue. If no such arrangement exists, product development fees are recognized ratably over the entire period during which the services are performed. |
|
|
| In making such assessments, judgments are required to evaluate contingencies such as potential variances in schedule and the costs, the impact of change orders, liability claims, contract disputes and achievement of contractual performance standards. Changes in total estimated contract cost and losses, if any, are recognized in the period they are determined. Billings on research and development contracts are typically based upon terms agreed upon by the Company and customer and are stated in the contracts themselves and do not always align with the revenues recognized by the Company. |
|
|
| Major Customers |
|
|
| Major customers of the Company are defined as having revenue greater than 10% of total gross revenue. For the three months ended March 31, 2014, three of our customers accounted for 50% of our revenue. For the three months ended March 31, 2013, four of our customers accounted for 70% of our revenue. One of these customers is the same for both periods. Accounts receivable related to the Companys major customers comprised 55% of all accounts receivable as of March 31, 2014. The loss of one or more of these customers could have a significant impact on our revenues and harm our business and results of operations. |
|
|
| Recent Accounting Pronouncements |
|
|
| There were no new accounting pronouncements for the three months ended March 31, 2014 that have a material impact on the Companys consolidated financial statements. |
9
4. | Inventories |
|
|
| Inventories are valued at the lower of cost, using the first-in, first-out (FIFO) method, or market. Inventories at March 31, 2014 and December 31, 2013 consist of: |
|
| March 31, 2014 |
| December 31, 2013 |
|
| (Unaudited) |
| (Audited) |
|
| (amounts in thousands) | ||
| Raw materials | $ 2,183 |
| $ 2,172 |
| Work in progress | 29 |
| 271 |
| Finished goods | 449 |
| 426 |
| Total | $ 2,661 |
| $ 2,869 |
5. | Stock-Based Compensation |
|
|
| The 1999 Director Stock Option Plan, as amended (the Director Plan), provides for the grant of stock options to non-employee directors of the Company at an exercise price equal to the fair market value per share on the date of the grant. An aggregate of 1,975,000 shares have been approved and authorized for issuance pursuant to this plan. A total of 2,309,798 options have been granted to non-employee directors through March 31, 2014 and 727,782 of those have been forfeited through March 31, 2014 and returned to the option pool. The options granted under the Director Plan vest in full one year after their respective grant dates and have a maximum term of ten years. |
|
|
| The 1999 Stock Incentive Plan, as amended (1999 Plan), replaced all previously authorized employee stock option plans, and no additional options may be granted under those previous plans. Under the 1999 Plan, options or stock awards may be granted to all of the Companys employees, officers, directors, consultants and advisors to purchase a maximum of 3,200,000 shares of common stock. However, pursuant to the terms of the 1999 Plan, no awards may be granted after March 16, 2009. A total of 2,892,500 options, having a maximum term of ten years, have been granted at 100% of the fair market value of the Companys common stock at the date of grant. Options outstanding under the 1999 Plan are generally exercisable in cumulative increments over four years commencing one year from date of grant. |
|
|
| On June 26, 2009, the Board of Directors adopted, and the Companys stockholders subsequently approved by partial written consent, the IGI Laboratories, Inc. 2009 Equity Incentive Plan (the 2009 Plan). The 2009 Plan became effective on July 29, 2009. The 2009 Plan allows the Company to continue to grant options and restricted stock, as under the 1999 Plan, but also authorizes the Board of Directors to grant a broad range of other equity-based awards, including stock appreciation rights, restricted stock units and performance awards. The 2009 Plan has been created, pursuant to and consistent with the Companys current compensation philosophy, to assist the Company in attracting, retaining and rewarding designated employees, directors, consultants and other service providers of the Company and its subsidiaries and affiliates, in a manner that will be cost efficient to the Company from both an economic and financial accounting perspective. On April 12, 2010, the Board of Directors adopted, and the Companys stockholders subsequently approved, an amendment and restatement of the 2009 Plan to increase the number of shares of Common Stock available for grant under such plan by adding 2,000,000 shares of Common Stock. The 2009 Plan, as amended on May 19, 2010, authorizes up to 4,000,000 shares of the Companys common stock for issuance pursuant to the terms of the 2009 Plan. The maximum number of shares that may be subject to awards made to any individual in any single calendar year under the 2009 Plan is 1,000,000 shares. As of March 31, 2014, options to purchase 1,911,500 shares of common stock were outstanding under the 2009 Plan. As of March 31, 2013, 1,473,748 shares of restricted stock had been granted under the 2009 Plan and 230,420 of those have been forfeited through March 31, 2014 and returned to the pool. |
|
|
| In summary, there are 2,765,500 options outstanding under the 1999 Plan, the Director Plan and the 2009 Plan, collectively as of March 31, 2014. |
10
| Stock Options |
|
|
| There are 1,200,820 options available for issuance under the 1999 Plan, the Director Plan, and the 2009 Plan collectively as of March 31, 2014. |
|
|
| The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing formula that uses assumptions noted in the following table. Expected volatilities and risk-free interest rates are based upon the expected life of the grant. The interest rates used are the U.S. Treasury yield curve in effect at the time of the grant. |
|
|
| For the three months ended |
|
|
| March 31, 2014 |
|
|
|
|
| Expected volatility |
| 44.0% - 47.1% |
| Expected term (in years) |
| 3.2 years |
| Risk-free rate |
| 0.74% - 1.01% |
| Expected dividends |
| 0% |
| A summary of option activity under the 1999 Plan, the Director Plan and the 2009 Plan as of March 31, 2014 and changes during the period are presented below: |
|
|
|
| Number of |
| Weighted |
|
|
|
|
| ||
| Outstanding as of January 1, 2014 | 2,643,500 |
| $1.12 | ||
| Issued |
|
| 172,000 |
| $3.14 |
| Exercised |
|
| - |
| - |
| Forfeited |
|
| (50,000) |
| $1.04 |
| Expired |
|
| - |
| - |
| Outstanding as of March 31, 2014 | 2,765,500 |
| $1.25 | ||
|
|
|
|
|
|
|
| Exercisable as of March 31, 2014 | 1,576,830 |
| $1.12 |
| Based upon application of the Black-Scholes option-pricing formula described above, the weighted-average grant-date fair value of options granted during the three months ended March 31, 2014 was $1.01. |
|
|
| The following table summarizes information regarding options outstanding and exercisable at March 31, 2014: |
| Outstanding: |
|
|
|
|
|
| ||
|
|
|
|
|
|
|
| Weighted Average | |
| Range of Exercise Prices |
| Stock Options |
| Weighted Average |
| Remaining | ||
|
|
|
|
|
|
|
|
| |
| $0.55 | $1.00 |
| 218,000 |
| $0.76 |
| 4.58 | |
| $1.01 | $1.50 |
| 2,164,000 |
| $1.09 |
| 7.65 | |
| $1.51 | $5.65 |
| 383,500 |
| $2.44 |
| 8.56 | |
| Total |
|
| 2,765,500 |
| $1.25 |
| 7.53 |
11
| Exercisable: |
|
|
|
| |
|
|
| Stock Options |
| Weighted Average | |
| Range of Exercise Prices |
| Exercisable |
| Exercise Price | |
|
|
|
|
|
|
|
| $0.55 | $1.00 |
| 214,000 |
| $0.75 |
| $1.01 | $1.50 |
| 1,212,830 |
| $1.12 |
| $1.51 | $5.65 |
| 150,000 |
| $1.67 |
| Total |
|
| 1,576,830 |
| $1.12 |
|
| Number of Restricted Stock |
| Weighted Average Exercise Price |
|
|
|
|
|
| Non-vested balance at January 1, 2014 | 246,001 |
| $ 2.64 |
|
|
|
|
|
| Changes during the period: |
|
|
|
| Shares granted | - |
| - |
| Shares vested | (29,334) |
| 1.00 |
| Shares forfeited | - |
| - |
|
|
|
|
|
| Non-vested balance at March 31, 2014 | 216,667 |
| $ 2.86 |
12
13
|
| 2014 |
| 2013 | ||||
|
|
|
| Weighted |
|
|
| Weighted |
|
|
|
| Average |
|
|
| Average |
|
| Warrants |
| Exercise Price |
| Warrants |
| Exercise Price |
|
|
|
|
|
|
|
|
|
| Beginning balance | 354,546 |
| $1.21 |
| 782,259 |
| $0.85 |
|
|
|
|
|
|
|
|
|
| Stock warrants granted | - |
| - |
| - |
| - |
| Stock warrants expired | - |
| - |
| - |
| - |
| Stock warrants exercised | (270,546) |
| 1.21 |
| (427,713) |
| 0.55 |
|
|
|
|
|
|
|
|
|
| Ending balance | 84,000 |
| $1.21 |
| 354,546 |
| $1.21 |
| In connection with the private placement of the Companys Common Stock on December 8, 2010, the Company granted Common Stock Warrants to purchase 338,182 and 16,364 shares, respectively, to each of its two placement agents for $1.21 per share which expire on December 8, 2015. On March 7, 2014, 270,546 of the 338,182 warrants were exercised. |
|
|
| In addition, the Company executed as of December 31, 2012 a settlement agreement with Amzak Capital Management, LLC in connection with a common stock purchase warrant that we issued to Amzak on December 21, 2012 under which the Company issued a ten-year warrant to purchase up to 427,713 shares of the Companys common stock, with an exercise price of $0.55 per share. The warrants were exercised in full on February 8, 2013. The amount of the fair value of the warrant issued was $209,000, and included as interest expense in 2012, as it related to the credit agreement which was terminated in August of 2012. |
|
|
10. | Asset Purchase Agreement |
|
|
| On February 1, 2013, the Company entered into an Asset Purchase Agreement (the Purchase Agreement) with Prasco, LLC, an Ohio limited liability company (Prasco), pursuant to which the Company purchased from Prasco assets associated with econazole nitrate cream 1% (the Product), which is available in 15g, 30g, and 85g tubes and has United States Food and Drug Administration approved indications for the treatment of tinea pedis, tinea cruris, and tinea corporis as well as the treatment of cutaneous candidiasis and tinea versicolor. |
14
| In consideration for the purchase of the assets pursuant to the Purchase Agreement, the Company paid Prasco $1.4 million in cash and paid an additional aggregate of $400,000 upon the occurrence of the milestone events (the Milestone Payment). The Milestone Payment is secured by a first-priority security interest in the acquired assets under the Purchase Agreement. The transaction is accounted for as a purchase of the product and product rights, and as such the initial payment, milestone payment and related costs to acquire the asset are included as part of product acquisition costs totaling $1.8 million. The Company capitalized and amortized the costs over fifteen years, the useful life of the acquired product and product rights. |
|
|
| Under and subject to the terms and conditions of the Purchase Agreement, Prasco continued to distribute the Product during a six-month period following the closing of the Purchase Agreement, and the Company completed the technical transfer of the Product and begun manufacturing the Product under its own label during the third quarter of 2013. Beginning in the third quarter of 2013, the Companys product sales included sales of the product. |
|
|
| In addition, the Purchase Agreement contains certain non-compete restrictions preventing Prasco from selling the Product in the United States for a period of seven years. |
|
|
| On October 23, 2013, the Company announced that it had received formal approval from the U.S. Food and Drug Administration (FDA) for the CBE-30 supplemental filing to approve the site transfer of the Econazole nitrate cream 1%, to the Companys manufacturing facility in Buena, NJ. |
|
|
11. | Legal |
|
|
| We are involved from time to time in claims which arise in the ordinary course of business. In the opinion of management, we have made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against us relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on our business, financial condition and operating results. |
|
|
| On December 19, 2013, we filed a complaint in the United States District Court for the District of Delaware against Mallinckrodt LLC, Mallinckrodt, Inc. and Nuvo Research Inc. (collectively, Mallinckrodt) seeking a declaration of non-infringement of United States Patent Nos. 8,217,078 and 8,546,450 so that we can bring our generic diclofenac sodium topical solution 1.5% to market at the earliest possible date under applicable statutory and FDA regulatory provisions. |
|
|
| On January 10, 2014, Mallinckrodt filed an answer and counterclaim alleging that IGI Laboratories, Inc. infringes the patents at issue. On January 28, 2014, we filed a motion to dismiss Mallinckrodts counterclaim and, on March 5, 2014, Mallinckrodt filed an opposition to such motion. The court has not yet rendered a decision. We believe the complaint has merit and we intend to continue to pursue Mallinckrodt. Based on the early stage of this complaint and counterclaim, we are unable to predict the outcome. |
|
|
| On April 22, 2014, the court issued a Memorandum Order, granting in part and denying in part IGIs motion to dismiss Mallinckrodts counterclaims. We continue to believe that our claims have merit and we continue to pursue them against Mallinckrodt. Based on the early stage of this case, we are unable to predict the outcome. |
15
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
This Managements Discussion and Analysis of Financial Condition and Results of Operations section and other sections of this Quarterly Report on Form 10-Q contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, that are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and on managements beliefs and assumptions. In addition, other written or oral statements, which constitute forward-looking statements, may be made by or on behalf of the Company. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, variations of such words and similar expressions are intended to identify such forward-looking statements. These statements are based on current expectations of management and are not guarantees of future performance, and involve certain risks, uncertainties and assumptions, which are difficult to predict. These risks and uncertainties include, without limitation, competitive factors, outsourcing trends in the pharmaceutical industry, the general economic conditions in the markets in which the Company operates, levels of industry research and development spending, the Companys ability to continue to attract and retain qualified personnel, the fixed price nature of product development agreements or the loss of customers and other factors described in the Companys filings with the Securities and Exchange Commission, including the Risk Factors section as set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, as updated below in this Quarterly Report on Form 10-Q. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. The forward-looking statements set forth herein speak only as of the date of this report. The Company undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by applicable law.
Company Overview
Strategic Overview
IGI Laboratories, Inc. is a developer, manufacturer, and marketer of topical formulations. Our goal is to become a leader in the generic topical pharmaceutical market. Under our IGI label, we sell generic topical pharmaceutical products that are bioequivalent to their brand name counterparts. We also provide development, formulation, and manufacturing services to the pharmaceutical, over-the-counter (OTC) and cosmetic markets.
Currently, we have two platforms for growth:
Manufacturing, developing, and marketing a portfolio of generic pharmaceutical products in our own label in topical dosage forms; and,
Increasing our current contract manufacturing and formulation services business.
In addition, we will continue to explore ways to accelerate our growth through the creation of unique opportunities from the acquisition of additional intellectual property, and the expansion of the use of our existing intellectual property, including our licensed Novasome® technology.
In December 2012, we completed the implementation of our commercial infrastructure and launched our first generic topical pharmaceutical products under the IGI label. To date, we have filed fourteen Abbreviated New Drug Applications, or ANDAs, with the United States Food and Drug Administration, or FDA for additional pharmaceutical products. On March 12, 2014, we received our first approval from the FDA for an ANDA. We expect to continue to expand our presence in the generic topical pharmaceutical market through the filing of additional ANDAs with the FDA and the subsequent launch of products as these applications are approved. Our target is to file at least ten ANDAs in 2014 through our internal research and development program. We will also seek to license or acquire further products, intellectual property, or ANDAs to expand our portfolio. On February 1, 2013, we acquired assets and intellectual property, including an ANDA, for econazole nitrate cream 1%, which we launched in September 2013.
IGI also develops, manufactures, fills, and packages topical semi-solid and liquid products for branded and generic pharmaceutical customers as well as the OTC and cosmetic markets. These products are used in a wide range of applications from cosmetics and cosmeceuticals to the prescription treatment of conditions like dermatitis, psoriasis, and eczema.
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Recent Events
On March 3, 2014, we submitted our first ANDA for 2014 to the FDA, which brought our total number of ANDA submissions to fourteen.
On March 12, 2014, we received our first approval from the FDA for an ANDA. Lidocaine hydrochloride USP 4% topical solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Based on November 2013 IMS Health data, the total addressable market for the generic version of this product is approximately $1.8 million, in which IGI will currently compete with two other manufacturers. IGI originally submitted this ANDA to the FDA in May 2012.
On May 7, 2014, we received a tentative approval from the FDA for an ANDA. Diclofenac sodium topical solution, 1.5% is a nonsteroidal anti-inflammatory drug indicated for the treatment of the pain of osteoarthritis of the knee. Based on recent IMS Health data, the total addressable market for this product is approximately $29 million. IGI originally submitted this ANDA to the FDA in December 2010.
Results of Operations
Three months ended March 31, 2014 compared to March 31, 2013
The Company had net income of $167,000, or $0.00 per share, for the three months ended March 31, 2014 compared to a net loss of $257,000, or $0.01 per share, for the three months ended March 31, 2013, which resulted from the following:
Revenues (in thousands):
Components of Revenue: | 2014 | 2013 | $ Change | % Change |
Product sales, net | $ 6,383 | $ 3,467 | $ 2,916 | 84% |
Research and development income | 313 | 159 | 154 | 97% |
Licensing, royalty and other revenue | 157 | 57 | 100 | 175% |
Total Revenues | $ 6,853 | $ 3,683 | $ 3,170 | 86% |
The increase in product sales for the three months ended March 31, 2014 as compared to the same period in 2013 was primarily due to the launch of our own generic pharmaceutical product line in the first quarter of 2013, including the launch of econazole nitrate cream 1% in September 2013, in addition to increased product sales to three of our major pharmaceutical customers, which was only partially offset by decreased sales to one of our cosmetic customers and two of our pharmaceutical customers. Research and development income will not be consistent and will vary, from period to period, depending on the required timeline of each development project. Licensing and royalty income increased slightly due to an increase in other revenue while licensing and royalty revenue remained the same.
Costs and expenses (in thousands):
| 2014 | 2013 | $ Change | % Change |
Cost of sales | $ 3,987 | $ 2,575 | $ 1,412 | 55% |
Selling, general and administrative | 1,282 | 679 | 603 | 89% |
Product development and research | 1,365 | 658 | 707 | 107% |
Totals costs and expenditures | $ 6,634 | $ 3,912 | 70% |
Cost of sales increased for the three months ended March 31, 2014 as a result of the increase in total revenue. Cost of sales as a percentage of total revenue was 58% for the three months ended March 31, 2014 as compared to 70% for the three months ended March 31, 2013. The decrease in cost of sales as a percentage of product sales for 2013 was attributable to increased revenue from the launch of our first four IGI label products, which have higher margins, and a shift in the mix of our product sales to include greater higher margin pharmaceutical products. Our research and development income results primarily from services rendered under contractual agreements, and therefore cost of sales as a percentage of our research and development income is relatively low. Consistent with our strategy, we expect cost of sales as a percentage of total revenue to decline over time.
17
Selling, general and administrative expenses for the three months ended March 31, 2014 increased by $603,000 as compared to the same period in 2013. There were increases of $191,000 in salaries, bonuses and related costs, $202,000 in the expense from the issuance of stock based compensation related to options and restricted stock, $113,000 in professional fees, $30,000 in amortization of product acquisition costs and $63,000 in other administrative expenses.
Product development and research expenses for the three months ended March 31, 2014 increased by $707,000 as compared to the same period in 2013. Consistent with our strategy to expand our portfolio of generic prescription topical pharmaceutical products, we increased headcount, which resulted in an increase of $17,000 in salaries and related costs. We increased spending on clinical studies by $446,000, pilot batch expense by $138,000, outside testing and supplies by $58,000 and overhead costs by $6,000. In addition we incurred an increase of approximately $48,000 in fees related to the Generic Drug User Fee Act and the associated filing of our applications with the FDA.
Interest expense and other, net (in thousands):
| 2014 | 2013 | $ Change | % Change |
Interest expense | $ 52 | $ 33 | $ 19 | 58 % |
Other | $ - | $ (5) | $ (5) | (100)% |
Interest expense increased for the three months ended March 31, 2014 as compared to the same period in 2013 due to the increase in the amount of the Note Payable Bank (see Note 8 to the Companys Consolidated Financial Statements) outstanding during the three months ended March 31, 2014 as compared to the same period in 2013.
Net income (loss) (in thousands, except per share numbers):
| 2014 | 2013 | $ Change | % Change |
Net income (loss) | $ 167 | $ (257) | $ 424 | 165% |
Net income (loss) per share | $ 0.00 | $ (0.01) | $ 0.01 | 100% |
Net income for the three months ended March 31, 2014 was $167,000 as compared to a net loss of $257,000 in the same period last year. This improvement is due to the increase in revenues, partially offset by the increases in costs and expenses described above.
Liquidity and Capital Resources
The Companys operating activities provided $63,000 of cash during the three months ended March 31, 2014 compared to $1,594,000 cash used in operating activities during the three months ended March 31, 2013. The cash provided by operating activities for the three months ended March 31, 2014 was substantially a result of the net income plus non-cash expenses for the period offset by a net decrease in operating assets and liabilities. The use of cash for the three months ended March 31, 2013 was a result of the net loss and the changes in operating assets and liabilities, particularly a significant increase in accounts receivable related to the launch of our IGI label products.
The Companys investing activities used $68,000 during the three months ended March 31, 2014 compared to $1,486,000 of cash used in investing activities during the three months ended March 31, 2013. The funds used for the three months ended March 31, 2014 were for additional IT equipment and equipment and improvements for the compounding area and the warehouse and the funds used for the period ended March 31, 2013 were for the purchase of econazole nitrate cream (see Note 10 to the Companys Consolidated Financial Statements) and additional equipment and improvements in the compounding area and packaging and filling lines.
The Companys financing activities provided $318,000 of cash during the three months ended March 31, 2014 compared to $1,190,000 of cash provided during the three months ended March 31, 2013. The cash provided for the three months ended March 31, 2014 was mainly the $327,000 proceeds from the exercise of common stock warrants and the cash provided for the three month period ended March 31, 2013 was mainly the proceeds of $1,000,000 from the drawdown of the Note Payable (see Note 8 to the Companys Consolidated Financial Statements) and $236,000 of proceeds from the exercise of common stock warrants.
18
The Companys principal sources of liquidity are cash and cash equivalents of approximately $2,414,000 at March 31, 2014, the $2,000,000 available on the $5,000,000 credit facility detailed in Note 8 and future cash from operations. The Company had working capital of $6,172,000 at March 31, 2014.
The Company may require additional funding and this funding will depend, in part, on the timing and structure of potential business arrangements. If necessary, the Company may continue to seek to raise additional capital through the sale of its equity or through a strategic alliance with a third party. There may also be additional acquisition and growth opportunities that may require external financing. There can be no assurance that such financing will be available on terms acceptable to the Company, or at all. We believe that our existing capital resources will be sufficient to support our current business plan beyond May 2015.
Off Balance Sheet Arrangements
The Company does not have any off balance sheet arrangements as of the date of this report.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
This item is not required as we are a smaller reporting company.
Critical Accounting Policies and Estimates
IGIs condensed consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles, which require management to make estimates and assumptions about future events that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ from these estimates.
Please refer to the Companys Form 10-K for the year ended December 31, 2013 for a complete list of all Critical Accounting Policies and Estimates. See also Note 3 to the Companys Consolidated Financial Statements.
ITEM 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Principal Financial and Accounting Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2014. Based on that evaluation, our Chief Executive Officer and Principal Financial and Accounting Officer concluded that, as of March 31, 2014, the Companys disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting during our first quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II
OTHER INFORMATION
ITEM 1. Legal Proceedings
We are involved from time to time in claims which arise in the ordinary course of business. In the opinion of management, we have made adequate provision for potential liabilities, if any, arising from any such matters. However, litigation is inherently unpredictable, and the costs and other effects of pending or future litigation, governmental investigations, legal and administrative cases and proceedings (whether civil or criminal), settlements, judgments and investigations, claims and changes in any such matters, and developments or assertions by or against us relating to intellectual property rights and intellectual property licenses, could have a material adverse effect on our business, financial condition and operating results.
19
On December 19, 2013, we filed a complaint in the United States District Court for the District of Delaware against Mallinckrodt LLC, Mallinckrodt, Inc. and Nuvo Research Inc. (collectively, Mallinckrodt) seeking a declaration of non-infringement of United States Patent Nos. 8,217,078 and 8,546,450 so that we can bring our generic diclofenac sodium topical solution 1.5% to market at the earliest possible date under applicable statutory and FDA regulatory provisions.
On January 10, 2014, Mallinckrodt filed an answer and counterclaim alleging that IGI Laboratories, Inc. infringes the patents at issue. On January 28, 2014, we filed a motion to dismiss Mallinckrodts counterclaim and, on March 5, 2014, Mallinckrodt filed an opposition to such motion. The court has not yet rendered a decision. We believe the complaint has merit and we intend to continue to pursue Mallinckrodt. Based on the early stage of this complaint and counterclaim, we are unable to predict the outcome.
On April 22, 2014, the court issued a Memorandum Order, granting in part and denying in part IGIs motion to dismiss Mallinckrodts counterclaims. We continue to believe that our claims have merit and we continue to pursue them against Mallinckrodt. Based on the early stage of this case, we are unable to predict the outcome.
ITEM 1A. Risk Factors.
Part I, Item 1A, Risk Factors, of our Annual Report on Form 10-K for the year ended December 31, 2013 includes a detailed discussion of risks and uncertainties which could adversely affect our future results. Except as set forth below, the risks described in our Annual Report on Form 10-K for the year ended December 31, 2013 have not materially changed.
Risks Related to Our Business
We rely on a limited number of customers for a large portion of our revenues.
We depend on a limited number of customers for a large portion of our revenue. Three of our customers accounted for 50% of our revenue for the three months ended March 31, 2014 and four of our customers accounted for 70% of our revenue for the three months ended March 31, 2013. The loss of one or more of these customers could have a significant impact on our revenues and harm our business and results of operations.
Prior to the fourth quarter of 2013, we have a history of losses and cannot assure you that we will become profitable, and as a result, we may have to cease operations and liquidate our business.
Our expenses have exceeded our revenue in each of the last nine years, and no net income has been available to common stockholders during each of these years. As of March 31, 2014, our stockholders equity was $7.9 million and we had an accumulated deficit of $45 million. Our future profitability depends on revenue exceeding expenses, but we cannot assure you that this will occur. If we do not become profitable or continue to raise external financing, we could be forced to curtail operations and sell or liquidate our business, and you could lose some or all of your investment.
Risks Related to Our Securities
Shares of our common stock are relatively illiquid which may affect the trading price of our common stock.
For the three months ended March 31, 2014, the average daily trading volume of our Common Stock on the NYSE Amex was approximately 325,000 shares. As a result of our relatively small public float, our Common Stock may be less liquid than the stock of companies with broader public ownership. Among other things, trading of a relatively small volume of our Common Stock may have a greater impact on the trading price for our shares than would be the case if our public float were larger.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
20
ITEM 3. Defaults Upon Senior Securities
None.
ITEM 4. Mine Safety Disclosures
Not applicable.
ITEM 5. Other Information
None.
ITEM 6. Exhibits
* Filed herewith.
21
SIGNATURES
Pursuant to the requirements 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.
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| IGI Laboratories, Inc. | |
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|
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|
Date: May 15, 2014 |
| By: | /s/ Jason Grenfell-Gardner |
|
|
| Jason Grenfell-Gardner |
|
|
| President and Chief Executive Officer |
|
|
|
|
Date: May 15, 2014 |
| By: | /s/ Jenniffer Collins |
|
|
| Jenniffer Collins |
|
|
| Chief Financial Officer |
* Filed herewith.
23