Exhibit 99.1
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Investor Contact:
The Investor Relations Group
Erika Moran/Dian Griesel, Ph.D.
Media Contact: Lynn Granito
Phone: 212-825-3210
Unigene Announces Financial Results
For First Quarter 2008
FAIRFIELD, N.J. – May 12, 2008 —Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) has reported its financial results for the quarter ended March 31, 2008.
Revenue for the three months ended March 31, 2008 was $4,314,000, compared to $6,328,000 for the three months ended March 31, 2007. Revenue for both periods primarily consisted of Fortical sales and royalties, which were $3,791,000 for the three months ended March 31, 2008, and $4,461,000 for the three months ended March 31, 2007. The three months ended March 31, 2007 included Fortical royalties for the four month period of December 2006 through March 2007 and also included $1,600,000 in revenue from Novartis under a 2007 supply agreement.
Net loss for the three months ended March 31, 2008 was $1,853,000, or $.02 per share, compared to a net loss of $244,000, or $.00 per share, for the three months ended March 31, 2007.
Total operating expenses were $5,862,000 for the three months ended March 31, 2008, a decrease of $342,000 from $6,204,000 for the three months ended March 31, 2007.
Cash at March 31, 2008 was $963,000, a decrease of approximately $2,715,000 from December 31, 2007. Accounts receivable at March 31, 2008 were $3,543,000.
Following are recent highlights and developments that will be discussed during Tuesday’s earnings call:
| • | | Revenues for the three months ended March 31, 2008 increased 42% compared to revenues for the three month period ended December 31, 2007 due to an increase in Fortical sales. Quarterly Fortical sales and royalties will continue to fluctuate due to the ordering patterns of Upsher-Smith and their supply contracts with third parties. |
| • | | In April 2008, Unigene and its partner expanded the scope of their Chinese joint venture and broke ground for a global biotechnology park. The joint venture, called Unigene Biotechnology Co. Ltd., will initially focus on calcitonin and parathyroid hormone (PTH) products for the Chinese market as well as global peptide manufacturing. The joint venture will also perform research, development, formulation and manufacturing. |
| • | | A subsidiary of our Chinese joint venture partner has entered into an agreement to purchase 1,080,000 shares of Unigene common stock at $1.86 per share, representing an 11% premium to the closing price on April 28, 2008, the date on which the parties agreed to the purchase price, in anticipation of finalizing the transaction documents. The total investment will be approximately $2 million. |
| • | | According to IMS, as of March 31, 2008, Fortical prescriptions have captured more than 55% of the U.S. nasal calcitonin market, making Fortical the most frequently prescribed nasal calcitonin product in the U.S. |
| • | | The U.S. FDA approved two improvements for the manufacture of calcitonin, the active ingredient in Fortical®.The combination of these improvements is expected to triple batch yields. |
| • | | Unigene successfully completed a Phase I/II study for its oral calcitonin program. Unigene will meet with the FDA shortly to confirm the design of the pivotal Phase III clinical study which Unigene intends to take forward with a corporate partner. |
| • | | Preparations are being finalized for a clinical study utilizing our improved oral formulation of PTH. |
| • | | In April 2008 it was reported that use of an oral bisphosphonate product for osteoporosis has been associated with an 86% increase in risk for atrial fibrillation, a known risk factor for stroke. |
Unigene will host a conference call tomorrow morning, Tuesday, May 13th at 9:00 AM EDT, to discuss its first quarter 2008 financial results and to provide a Company update. The Company invites all those interested in hearing management’s discussion to join the call by dialing 866-585-6398 for participants in the United States and 416-849-9626 for international participants. A replay will be available for seven days after the call and can be accessed by dialing 866-245-6755 for participants in the United States and 416-915-1035 for international participants. When prompted, enter passcode #343608. The conference call may also be accessed via the Web at www.unigene.com; a link will be provided for listeners to join the call.
UNIGENE LABORATORIES, INC.
CONDENSED BALANCE SHEETS
| | | | | | | | |
| | March 31, 2008 | | | December 31, 2007 | |
| | (Unaudited) | | | | |
ASSETS | | | | | | | | |
Current assets: | | | | | | | | |
Cash and cash equivalents | | $ | 962,937 | | | $ | 3,677,637 | |
Accounts receivable | | | 3,542,987 | | | | 3,142,196 | |
Inventory | | | 3,528,691 | | | | 3,327,289 | |
Prepaid expenses and other current assets | | | 569,531 | | | | 908,168 | |
| | | | | | | | |
Total current assets | | | 8,604,146 | | | | 11,055,290 | |
| | |
Noncurrent inventory | | | 724,822 | | | | 627,020 | |
Property, plant and equipment, net | | | 4,270,320 | | | | 3,217,608 | |
Patents and other intangibles, net | | | 1,858,528 | | | | 1,810,987 | |
Investment in joint venture | | | 26,349 | | | | 27,440 | |
Other assets | | | 177,739 | | | | 135,815 | |
| | | | | | | | |
Total assets | | $ | 15,661,904 | | | $ | 16,874,160 | |
| | | | | | | | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | | | | | | | | |
Current liabilities: | | | | | | | | |
Accounts payable | | $ | 1,895,961 | | | $ | 1,328,272 | |
Accrued expenses - other | | | 1,955,971 | | | | 1,983,558 | |
Current portion - deferred licensing fees | | | 1,281,756 | | | | 1,313,006 | |
Current portion - capital lease obligations | | | 30,374 | | | | 40,078 | |
| | | | | | | | |
Total current liabilities | | | 5,164,062 | | | | 4,664,914 | |
| | |
Notes payable – stockholders | | | 15,737,517 | | | | 15,737,517 | |
Accrued interest – stockholders | | | 1,099,270 | | | | 783,279 | |
Deferred licensing fees, excluding current portion | | | 11,668,639 | | | | 11,982,829 | |
Capital lease obligations, excluding current portion | | | — | | | | 1,865 | |
Deferred compensation | | | 377,013 | | | | 374,500 | |
| | | | | | | | |
Total liabilities | | | 34,046,501 | | | | 33,544,904 | |
| | | | | | | | |
Commitments and contingencies | | | | | | | | |
| | |
Stockholders’ deficit: | | | | | | | | |
| | |
Common Stock - par value $.01 per share, authorized 135,000,000 shares, issued and outstanding: 87,753,715 shares in 2008 and 2007 | | | 877,537 | | | | 877,537 | |
Additional paid-in capital | | | 105,844,800 | | | | 105,705,387 | |
Accumulated deficit | | | (125,106,934 | ) | | | (123,253,668 | ) |
| | | | | | | | |
Total stockholders’ deficit | | | (18,384,597 | ) | | | (16,670,744 | ) |
| | | | | | | | |
Total liabilities and stockholders’ deficit | | $ | 15,661,904 | | | $ | 16,874,160 | |
| | | | | | | | |
UNIGENE LABORATORIES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
| | | | | | | | |
| | Three months ended March 31, | |
| | 2008 | | | 2007 | |
Revenue: | | | | | | | | |
Product sales | | $ | 2,652,454 | | | $ | 4,023,732 | |
Royalties | | | 1,138,363 | | | | 1,845,442 | |
Licensing revenue | | | 314,190 | | | | 230,856 | |
Development fees and other | | | 209,091 | | | | 228,242 | |
| | | | | | | | |
| | | 4,314,098 | | | | 6,328,272 | |
| | | | | | | | |
Operating expenses: | | | | | | | | |
Research, development and facility expenses | | | 2,125,946 | | | | 2,124,135 | |
Cost of goods sold | | | 1,589,794 | | | | 2,019,651 | |
General and administrative | | | 2,146,093 | | | | 2,060,235 | |
| | | | | | | | |
| | | 5,861,833 | | | | 6,204,021 | |
| | | | | | | | |
Operating (loss) income | | | (1,547,735 | ) | | | 124,251 | |
| | |
Other income (expense): | | | | | | | | |
Interest income | | | 19,281 | | | | 31,723 | |
Interest expense-principally to stockholders | | | (324,812 | ) | | | (400,142 | ) |
| | | | | | | | |
Loss before income taxes | | | (1,853,266 | ) | | | (244,168 | ) |
Income tax expense | | | — | | | | — | |
| | | | | | | | |
Net loss | | $ | (1,853,266 | ) | | $ | (244,168 | ) |
| | | | | | | | |
Loss per share – basic and diluted: | | | | | | | | |
Net loss per share | | $ | (0.02 | ) | | $ | (0.00 | ) |
| | | | | | | | |
Weighted average number of shares outstanding - basic and diluted | | | 87,753,715 | | | | 87,731,376 | |
| | | | | | | | |
About Unigene
Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs. Due to the size of the worldwide osteoporosis market, Unigene is targeting its initial efforts on developing calcitonin and PTH-based therapies. Fortical®, Unigene’s nasal calcitonin product for the treatment of postmenopausal osteoporosis, received FDA approval and was launched in August 2005. Unigene has licensed the U.S. rights for Fortical to Upsher-Smith Laboratories, worldwide rights for its oral PTH technology to GlaxoSmithKline and worldwide rights for its calcitonin manufacturing technology to Novartis. Unigene’s patented oral delivery technology has successfully delivered, in preclinical and/or clinical trials, various peptides including calcitonin, PTH and insulin. Unigene’s patented manufacturing technology is designed to cost-effectively produce peptides in quantities sufficient to support their worldwide commercialization as oral or nasal therapeutics. For more information about Unigene, call (973) 882-0860 or visit www.unigene.com. For information about Fortical, visit www.fortical.com.
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements regarding us and our business, financial condition, results of operations and prospects. Such forward-looking statements include those which express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact. We have based these forward-looking statements on our current expectations and projections about future events and they are subject to risks and uncertainties known and unknown which could cause actual results and developments to differ materially from those expressed or implied in such statements. These forward-looking statements include statements about the following: general economic and business conditions, our financial condition, competition, our dependence on other companies to commercialize, manufacture and sell products using our technologies, the ability of our products to gain market acceptance and increase market share, the uncertainty of results of animal and human testing, the risk of product liability and liability for human trials, our dependence on patents and other proprietary rights, dependence on key management officials, the availability and cost of capital, the availability of qualified personnel, changes in, or the failure to comply with, governmental regulations, the failure to obtain regulatory approvals for our products and other risk factors discussed in our Securities and Exchange Commission filings. Words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “potential,” “continue,” and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward-looking statements. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various risk factors.