San Diego-based Zogenix, which markets a needle-free injector for treating migraines, intends to raise $90 million through an initial public stock offering, according to a recent regulatory filing.
The biotech startup, which I profiled last month, has also been developing compounds for treating pain and central nervous system disorders, and plans to pair each new drug with its proprietary “DosePro” injector as a drug-and-device combination in seeking FDA approval. Zogenix CEO Roger Hawley told me the company has raised nearly $200 million ($164 million in venture funding and $35 million in debt financing) since it was founded in 2006.
Zogenix withdrew from a previous IPO filing that it submitted in 2008. Hawley told me last month the company required additional funding, and hinted that he wanted to get the Zogenix board to consider another IPO attempt.
Zogenix made the commercial launch of its migraine injector, which delivers the drug sumatriptan, in the United States nine months ago; it sells the drug-and-device combination as Sumavel DosePro, under a marketing agreement with Astellas Pharma. Zogenix says it also has entered into a partnership with Germany’s Desitin Arzneimittel GmbH to accelerate development and regulatory approvals in Europe.
The company also is in late-stage clinical trials for a formulation of hydrocodone, which Zogenix licensed from Elan, for treatment of severe, chronic pain in patients requiring around-the-clock opioid therapy.
In its filing with the SEC, Zogenix details its financial risks, saying the company is “largely dependent on the commercial success of Sumavel DosePro,” and has recognized just $6.1 million in net product revenue from January through the end of June. The company has incurred substantial losses since it was founded. It disclosed a net loss of $45.9 million in 2009 and $49.3 million for the first half of 2010, and shows accumulated debt of $173.8 million. The company also identifies extensive competition among large, well-capitalized companies offering treatments for migraines which, like Zogenix’s injection, are in the so-called triptan class. Zogenix says it expects its losses and negative cash flows to continue at least for several more years.
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