Aug 10 2010
Unigene Laboratories, Inc. (OTCBB: UGNE, http://www.unigene.com) has reported its financial results for the quarter ended June 30, 2010.
Revenue for the three months ended June 30, 2010 was $3,028,000, compared to $4,297,000 for the three months ended June 30, 2009. Revenue for both periods primarily consisted of Fortical sales and royalties which have declined since the launch of competitive products in December 2008. Fortical sales were $1,387,000 for the three months ended June 30, 2010, compared to $2,730,000 for the three months ended June 30, 2009. Fortical sales fluctuate each quarter based upon Upsher-Smith Laboratories' ordering schedule. Fortical royalties were $906,000 for the three months ended June 30, 2010, compared to $1,078,000 for the three months ended June 30, 2009. Fortical royalties fluctuate each quarter based upon the timing, pricing and volume of USL's shipments to its customers.
Revenue for the six months ended June 30, 2010 was $5,561,000, compared to $7,488,000 for the six months ended June 30, 2009. Revenue for both periods primarily consisted of Fortical sales and royalties. Fortical sales were $2,676,000 for the six months ended June 30, 2010, compared to $4,039,000 for the six months ended June 30, 2009. Fortical royalties were $1,685,000 for the six months ended June 30, 2010, compared to $2,404,000 for the six months ended June 30, 2009.
Total operating expenses, including an accrual of $1,120,000 for future estimated severance payments, were $6,030,000 ($4,910,000 before severance accrual) for the three months ended June 30, 2010, a decrease of $615,000 from $6,645,000 for the three months ended June 30, 2009. Total operating expenses, including an accrual of $1,120,000 for future estimated severance payments, as well as a non-cash inventory reserve change of $576,000, were $11,363,000 ($10,243,000 before severance accrual) for the six months ended June 30, 2010, a decrease of $726,000 from $12,089,000 for the six months ended June 30, 2009.
Net loss for the three months ended June 30, 2010 was $3,644,000, or $.04 per share, compared to a net loss of $3,460,000, or $.04 per share, for the three months ended June 30, 2009.
Net loss for the six months ended June 30, 2010 was $19,591,000, or $.21 per share, compared to a net loss of $6,735,000, or $.07 per share, for the six months ended June 30, 2009. Non-cash expenses included in the net loss for the six months ended June 30, 2010 include $8,125,000 in loss on change in fair value of embedded conversion feature, $1,171,000 in non-cash interest expense, $576,000 in inventory reserve provision and $943,000 in non-cash equity compensation and depreciation and amortization expense.
Cash at June 30, 2010 was $10,583,000, an increase of approximately $5,689,000 from December 31, 2009.
Following are recent highlights and developments that will be discussed during Tuesday's earnings call:
- In June 2010 we announced the appointment of Ashleigh Palmer as President and Chief Executive Officer. Mr. Palmer also was named a member of Unigene's Board of Directors. He brings to Unigene extensive healthcare operational experience, as well as a successful track record in building out R&D and commercial capabilities.
- Data from IMS indicate that as of April 2010, Fortical® had a 40% share of U.S. nasal calcitonin prescriptions. Beginning in December 2008, three products have launched which are generic to the innovator product, but not to Fortical. Certain providers have substituted these products for Fortical, causing Fortical sales and royalties to decrease. Despite the availability of these competing products, Fortical still remains the most frequently prescribed nasal calcitonin product in the U.S.
- In July 2010 we announced that Tarsa Therapeutics had completed patient enrollment in the Phase III ORACAL trial of Tarsa's oral calcitonin product for the treatment of postmenopausal osteoporosis. Unigene licensed the product to Tarsa and owns 26% of the company. The ORACAL study is a multinational, randomized, double-blind, placebo-controlled Phase III trial designed to enroll approximately 550 patients. Tarsa also announced that the independent Data Monitoring Committee (DMC) for the ORACAL trial has completed two separate safety reviews of patient data and recommended that the trial proceed as planned.
Unigene Laboratories, Inc.