Amylin Pharmaceuticals Inc. is raising $465 million through a public offering that will double its cash position and support ongoing commercialization, development and manufacturing efforts.
The company agreed to sell 10 million shares of its common stock - more than the 8.5 million shares anticipated when Amylin filed a registration statement earlier this month - priced at $46.50 per share. If underwriters exercise their full 1.5 million-share overallotment option, the company could receive net proceeds of about $507.7 million.
Add that to the $443 million in cash and short-term investments Amylin reported at the end of 2005, and the company would have between $800 million and $900 million, an amount that "really gives us the flexibility to execute our business plan," said Mark Foletta, senior vice president of finance and chief financial officer of the San Diego-based company.
Besides, he added, "you never say never to capital," especially when the company has doubled in size since early 2005 on the approval of two diabetes products.
Amylin won clearance in March 2005 for Symlin (pramlintide acetate) injection as an adjunctive therapy to improve glycemic control in patients with either Type I or Type II diabetes who already are being treated with mealtime insulin. Symlin sales were $6.5 million for the last three months of 2005.
But it’s the company’s second product, Byetta (exenatide) injection, that is rapidly gaining a large share of the diabetes market. For the fourth quarter, net sales of Byetta totaled $49.7 million, and analysts are predicting significant growth over the next few years.
Analyst Jim Reddoch, of Arlington, Va.-based Friedman, Billings, Ramsey & Co., wrote in a research note that he projects first-quarter 2006 sales to increase by 54 percent over fourth-quarter numbers to $77 million, significantly above consensus estimates of $60 million. Reddoch is projecting total 2006 sales of $415 million, citing "increased sales potential," and "continued positive sentiment among clinicians toward the drug."
Byetta is partnered with Indianapolis-based Eli Lilly and Co., which has co-promotion rights in the U.S. and is responsible for developing and commercializing the product in the rest of the world. Operating profits from Byetta sales will be split evenly between the companies in the U.S. Ex-U.S. sales will be divided 80-20, with Lilly getting the larger portion.
"It’s very exciting for us, having launched those two products last year, and then seeing the uptake in the marketplace," Foletta said.
Proceeds from the sale will be used to support growth of both the company and its development pipeline. Some funds will go toward commercialization efforts to increase Byetta’s market penetration. While the company established the base of its sales force last year, it anticipates "incremental increases as we move forward," Foletta said.
Research and development work will continue focusing on exenatide LAR, a long-acting formulation of Byetta that recently entered a 300-patient non-inferiority study against twice-daily Byetta.
"We believe that study could provide the type of data to ultimately register the product," Foletta said.
Earlier in its pipeline, Amylin has pramlintide, which recently completed Phase IIb studies.
Money also will be used to establish additional manufacturing sources, including Amylin’s recently purchased facility in West Chester, Ohio, as part of the company’s expansion plan for manufacturing exenatide LAR. The company is expected to spend "up to $150 million over the next three years to bring that facility online," Foletta said.
Amylin, which reported a net loss of $67.2 million, or 61 cents per share, for the fourth quarter, has not released expense guidance for 2006. But FBR’s Reddoch projected research and development costs for the year to total $155 million, and selling, general and administrative expenses to total $235 million.
Last year, the company brought in more than $320 million through public financings. It raised $152 million in August, only days after its stock jumped 27 percent on positive early Phase II results of exenatide LAR. In that offering, Amylin sold more than 5 million shares priced at $31 each. In January, the company sold 8 million shares at $22 apiece, bringing in $176 million in anticipation of approvals for Symlin and Byetta. (See BioWorld Today, Jan. 24, 2005, and Aug. 31, 2005.)
Shares of Amylin (NASDAQ:AMLN) closed at $48.35 Thursday, up $1.49.
In other financing news:
• AVEO Pharmaceuticals Inc., of Cambridge, Mass., received $15 million of debt financing from Palo Alto, Calif.-based Hercules Technology Growth Capital. AVEO is developing targeted therapies for cancer, and is focused on discovering genes essential for tumor maintenance using its MaSS Screen technology.
• Cadence Pharmaceuticals Inc., of San Diego, completed its previously announced $53.8 million equity financing to support its newly acquired rights to an intravenous formulation of acetaminophen (IV APAP) from New York-based Bristol-Myers Squibb Co. Funding will be used to cover an up-front payment to BMS, and for further development of the Phase III-stage product. (See BioWorld Today, Feb. 23, 2006.)
• Cerus Corp., of Concord, Calif., closed a follow-on equity offering of 5.2 million shares, including the overallotment option, priced at $8.75 each to bring in net proceeds of $42.6 million. Funds will be used to support research and development. Cerus focuses on developing and commercializing products in the areas of immunotherapy and blood safety, and is preparing to start Phase I testing with its CRS-100, a Listeria-based immunotherapeutic aimed at treating cancer that has metastasized to the liver. Shares of Cerus (NASDAQ:CERS) closed at $8.51 Thursday, down 24 cents.
• Debiopharm SA, of Lausanne, Switzerland, said its wholly owned investment affiliate, Debioinnovation, invested capital into Chiba, Japan-based NanoCarrier Co. Ltd.’s mezzanine funding round of 400 million yen (US$3.4 million). That is the third equity investment made by Debioinnovation to complement the in-licensing objectives of Debiopharm, which in April 2005 agreed to license ND-01, a DACH-platin based on NanoCarrier’s micellar nanoparticle drug delivery systems technology, MediCelle. ND-01 has shown antitumor activity in animal models.
• Esprit Pharma Inc., of East Brunswick, N.J., secured a $50 million credit facility from Drawbridge Special Opportunities Fund, a fund managed by New York-based Fortress Investment Group. The facility will be used for general corporate purposes, including working capital needs, and to facilitate future acquisitions as part of the company’s growth strategy. Esprit focuses on acquiring, developing and marketing products for the genito-urinary and women’s health markets.
• Kosan Biosciences Inc., of Hayward, Calif., priced an offering of 5 million shares at $5 each to raise gross proceeds of $25 million. The company also is offering underwriters an option to purchase up to an additional 750,000 shares to cover overallotments. The offering is expected to close April 4. Credit Suisse Securities LLC is acting as sole bookrunner, and Cowen & Co. LLC is acting as co-lead manager. Shares of Kosan (NASDAQ:KOSN) lost 54 cents Thursday to close at $5.34.
• Seattle Genetics Inc., of Bothell, Wash., received net proceeds of $37.2 million from its offering of 7.3 million shares. Money will be used to fund clinical and preclinical development of its existing product candidates, as well as manufacturing of clinical-grade materials, and for other research and development initiatives. New York firms Banc of America Securities LLC and CIBC World Markets Corp. are acting as joint book-running managers for the offering, expected to close on or about April 3. In addition, the company also agreed to sell 1.1 million shares to investment funds affiliated with Baker Brothers Investments at a price of $5.25 each. Shares of Seattle Genetics (NASDAQ:SGEN) closed at $5.15 Thursday, down 3 cents.
• Viral Genetics Inc., of Azusa, Calif., sold 10 percent senior secured convertible debentures in the aggregate principal amount of $2.9 million, together with warrants to purchase 6.4 million shares of common stock over a period of five years at a price of 78 cents each, unit warrants to buy up to $2.1 million of additional debentures and additional warrants to purchase 4.7 million shares. Viral Genetics received the first $2.5 million of gross proceeds, and the remainder is expected within the week. Proceeds will be used to fund ongoing drug development and testing, as well as for working capital. Shares of Viral Genetics (OTC BB:VRAL) closed at 67 cents Thursday, down 3 cents.