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In a release on August 10, the Company reported revenue for the three months ended June 30, was $4,297,000, compared to $4,978,000 for the three months ended June 30, 2008. Revenue for both periods primarily consisted of Fortical sales and royalties, which were $3,807,000 for the three months ended June 30, and $4,110,000 for the three months ended June 30, 2008. Fortical royalties were $1,077,000 for the three months ended June 30, compared to $1,475,000 for the three months ended June 30, 2008. Fortical sales were $2,730,000 for the three months ended June 30, compared to $2,635,000 for the three months ended June 30, 2008. Fortical sales fluctuate each quarter based upon USL's ordering schedule. Fortical royalties fluctuate each quarter based upon the timing, pricing and volume of USL's shipments to its customers, and Fortical net sales have declined since the launch of competitive products in December 2008.
Revenue for the six months ended June 30, was $7,488,000, compared to $9,292,000 for the six months ended June 30, 2008. Revenue for both periods primarily consisted of Fortical sales and royalties, which were $6,443,000 for the six months ended June 30, and $7,900,000 for the six months ended June 30, 2008. Fortical royalties were $2,404,000 for the six months ended June 30, compared to $2,613,000 for the six months ended June 30, 2008. Fortical sales were $4,039,000 for the six months ended June 30, compared to $5,287,000 for the six months ended June 30, 2008.
Total operating expenses were $6,645,000 for the three months ended June 30, an increase of $801,000 from $5,844,000 for the three months ended June 30, 2008.
Total operating expenses were $12,089,000 for the six months ended June 30, an increase of $384,000 from $11,705,000 for the six months ended June 30, 2008.
Net loss for the three months ended June 30, was $3,460,000, or $.04 per share, compared to a net loss of $1,201,000, or $.01 per share, for the three months ended June 30, 2008.
Net loss for the six months ended June 30, was $6,735,000, or $.07 per share, compared to a net loss of $3,055,000, or $.03 per share, for the six months ended June 30, 2008.
Cash at June 30, was $4,599,000, a decrease of approximately $3,985,000 from December 31, 2008. Accounts receivable at June 30, were $3,310,000.
Following are recent highlights and developments that will be discussed during Tuesday's earnings call:
- According to IMS, in April 2009, Fortical had a 53 percent share of U.S. nasal calcitonin prescriptions, down from the 58 percent February market share. The decrease in market share is attributable to the early December launch of two products generic to the innovator product, but not to Fortical. Fortical sales and royalties increased 44 percent in the second quarter of 2009 as compared with the first quarter of 2009. We do not yet know the long-term effect on Fortical sales and royalties of the launch of these competing products. However, certain providers have substituted these products for Fortical, causing Fortical sales and royalties to decrease. Despite the availability of these competing products, their impact on Fortical prescriptions has been moderate to date and Fortical still remains the most frequently prescribed nasal calcitonin product in the U.S.
- For our oral calcitonin product, we are preparing for our upcoming Phase III trial and are finalizing our efforts to enlist a corporate partner and plan to transfer financial responsibility for the program as soon as possible.
- In May, we reported that our first patent covering our Site-Directed Bone Growth (SDBG) technology had issued. The technology, jointly invented in collaboration with Yale School of Medicine, is designed to facilitate and accelerate bone growth at precisely targeted locations in the body using a simple surgical procedure that can be performed on an outpatient basis with minimal invasiveness.
- In May, we drew down the remaining $5 million in non-convertible notes from our largest institutional stockholder. We will need additional sources of cash, from revenue or other sources, to meet our requirements in the near-term.
Unigene Laboratories, Inc. is a biopharmaceutical company focusing on the oral and nasal delivery of large-market peptide drugs.
((Comments on this story may be sent to health@closeupmedia.com))
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