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FibroGen Announces 2014 Financial Results and Provides Corporate UpdateFibroGen, Inc. (Nasdaq: FGEN), a research-based biopharmaceutical company, today provided a corporate update and reported financial results for the year-ended December 31, 2014. "FibroGen made excellent progress in 2014 on our lead clinical programs in anemia, fibrosis, and cancer," said Thomas Neff, chief executive officer of FibroGen. "We and our partners in the global development of roxadustat reached agreement on final protocols and are enrolling seven Phase 3 clinical trials of roxadustat for anemia in chronic kidney disease (CKD) in the US, Europe, and Asia Pacific, excluding Japan and China. Clinical trials of idiopathic pulmonary fibrosis and Stage 3 pancreatic cancer are on track, and we are now expanding our fibrosis program to include Duchenne muscular dystrophy." "We ended 2014 with cash, cash equivalents, investments, and receivables of $346.8 million. As part of this amount, we received net proceeds of $171.8 million from our November 2014 initial public offering." "In 2015, we expect to reach the cap on shared costs agreed upon with AstraZeneca for roxadustat CKD anemia development costs for the territories outside of China, after which, the costs we incur are reimbursed by our partners, as is described elsewhere in this press release." "In addition, we expect non-contingent license and milestone payments of nearly $200 million in the next 15 months. We remain confident that our roxadustat CKD anemia program is fully funded through the planned Phase 3 clinical development program." Recent Development Update Roxadustat in Anemia of Chronic Kidney Disease
FG-3019 in Idiopathic Pulmonary Fibrosis
FG-3019 in Pancreatic Cancer
FG-3019 in Duchenne Muscular Dystrophy (DMD)
China Manufacturing Certification
Financial Results (unaudited) Revenue, Operating Expenses, Net Loss, and EPS for the year ended December 31, 2014
Cost-Sharing Arrangements: FibroGen has two cost sharing arrangements with its collaboration partners, Astellas and AstraZeneca, for roxadustat.
Cash, Cash Equivalents, Investments, and Receivables
Conference Call Details FibroGen will host a conference call and webcast today, March 26, 2015 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time), to discuss financial results and provide a business update. Interested parties may access a live audio webcast of the conference call via the investor section of the FibroGen website, www.fibrogen.com. To access the conference call by telephone, please dial (800) 708-4540 (U.S. and Canada) or (847) 619-6397 (international), reference the FibroGen Fourth Quarter 2014 conference call, and use the confirmation number 39222014. To ensure timely connection, it is recommended that listeners register 15 minutes before the scheduled start time. A replay of the webcast will be archived on the FibroGen website and accessible approximately two hours after the event. About FibroGen FibroGen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. We have capitalized on our extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate multiple programs targeting various therapeutic areas. Our most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases, or HIF-PHs, in Phase 3 clinical development for the treatment of anemia in chronic kidney disease, or CKD. Our second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, pancreatic cancer and liver fibrosis. Forward Looking Statements This release contains forward-looking statements, including statements regarding our milestones, clinical plans and financial projections. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including the continued progress and timing of our various clinical programs, including the timing of enrollment of the Phase 3 clinical trials for roxadustat in CKD and the initiation and enrollment in ongoing and IND filing for planned clinical trials for FG-3019 in idiopathic pulmonary fibrosis and pancreatic cancer, and Duchenne muscular dystrophy, respectively; our ability to maintain the roxadustat CKD program as fully-funded through Phase 3; the potential to achieve and receive approximately $200 million in milestones from our collaborators in the next 15 months; the continued progress of our plans and programs in China; and other matters that are described in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, including the risk factors set forth in that filing. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
ABOUT NON-GAAP FINANCIAL MEASURES To supplement our consolidated financial statements, which are prepared and presented in accordance with GAAP, we present non-GAAP calculations for EPS in 2014 on a primary basis. The presentation of this financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information prepared and presented in accordance with GAAP. Non-GAAP EPS We define non-GAAP EPS as GAAP net income divided by our outstanding common shares as of December 31, 2014. Outstanding common shares as of December 31, 2014 were 59.0 million. With a starting point of 13.2 million shares outstanding as of December 31, 2013, we sold 9.3 million shares in our initial public offering in November 2014, side by side with placement of 1.1 million shares with AstraZeneca. The resulting automatic conversion of the Company's outstanding convertible preferred stock into 33.9 million shares of common stock, plus the resulting exchange of our European subsidiary's preferred shares into 1.0 million shares of common stock, and 0.5 million shares related to option exercises, resulted in 35.4 million converted shares. The total of the above results in 59.0 million outstanding common shares at December 31, 2014, compared to 13.2 million common shares as of December 31, 2013. Based on weighted average common shares outstanding of 18.8 million for the full year 2014, net loss per share for the year ended December 31, 2014 was $3.17. The weighting factor is based on the number of days in the calendar year the shares were outstanding.
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