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OncoMed Pharmaceuticals Announces Full Year And Fourth Quarter 2013 Financial Results

-- Granted a fourth broad U.S. patent (No. 8,628,744) relating to antibodies that target the RSPO-LGR pathway, which is believed to be an important CSC pathway.

-- In December, announced an agreement with Celgene Corporation to jointly develop and commercialize up to six anti-cancer stem cell biologic product candidates, including demcizumab (OMP-21M18, anti-DLL4). Celgene also has an option to discover and develop small molecule compounds in an undisclosed cancer stem cell pathway.
  • OncoMed will lead early clinical development efforts and retain worldwide co-development, U.S. co-commercialization and profit-sharing rights for up to five of the six biologic programs encompassed in the agreement.  
  • OncoMed received a $177.25 million upfront payment from Celgene, which included a $22.25 million equity investment. The collaboration also includes option exercise payments and payments for achievement of development, regulatory and commercial milestones, paid on a per-program basis. 

-- Presented data for four clinical-stage programs in October at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, including safety and efficacy data from Phase 1b clinical studies of demcizumab, pharmacodynamic biomarker data from a Phase 1a clinical study of vantictumab, the first clinical data from ongoing Phase 1a clinical studies of OMP-52M51 (anti-Notch1) and OMP-54F28.

-- In October, OncoMed earned a $15 million milestone payment from Bayer related to achieving a dose-escalation milestone in the ongoing Phase 1a clinical trial of OMP-54F28.

Full Year and Fourth Quarter 2013 Financial Results

Cash, cash equivalents and marketable securities totaled $316.2 million as of December 31, 2013, compared to $66.2 million as of December 31, 2012. The cash increase was driven by net proceeds of $87.3 million from OncoMed's initial public offering in July 2013, and the upfront and equity payments of $177.25 million from the signing of the company's collaboration with Celgene in December 2013.

Revenues for the full year 2013 totaled $37.8 million, as compared to $24.7 million in 2012. Fourth quarter 2013 revenues were $19.0 million, compared to $6.9 million for the fourth quarter of 2012. The year-over-year and quarter-over-quarter increases were attributable to collaborative revenues in the form of milestone payments from Bayer associated with the vantictumab and OMP-54F28 programs received in the fourth quarter 2013 and the amortization of upfront payments from OncoMed's agreements with GSK, Bayer and Celgene.

Research and development (R&D) expenses for the full year ended December 31, 2013, were $50.0 million compared with $39.9 million for the same period in 2012. For the fourth quarter of 2013 R&D expenses were $16.9 million, compared to $9.5 million for the fourth quarter of 2012. Increases in R&D expenditures during 2013 and the fourth quarter were primarily attributable to an increase in program costs associated with the advancement of OncoMed's clinical-stage product candidates and preclinical pipeline.

General and administrative (G&A) expenses for the years ended December 31, 2013 and 2012, were $11.6 million and $7.2 million, respectively. For the fourth quarter of 2013 G&A expenses were $4.5 million, compared to $1.8 million for the fourth quarter of 2012. Increased costs for 2013 and the quarter ended December 31, 2013 were primarily attributable to higher one-time employee-related costs, higher legal fees associated with SEC filings and consulting fees from third-party vendors associated with public company operations and multiple business development activities.

Net loss for the year ended December 31, 2013 was $26.1 million ($1.93 per share), compared to $22.2 million ($21.30 per share, pre-IPO and reverse split) for the same period of 2012. The change in net loss for the year was due to an increase of collaboration revenue, more than offset by an increase in operational expenses, primarily research costs. Net loss in the fourth quarter of 2013 was the same for the fourth quarter 2012 at $4.3 million. Net loss per share available to common stockholders for the fourth quarter of 2013 was $0.15 per share, compared to $4.01 per share (pre-IPO and reverse split) for the fourth quarter of 2012. The number of shares outstanding of OncoMed's common stock as of March 11, 2014 was 29,480,494.

Chief Financial Officer

OncoMed also announced that Sunil Patel, Chief Financial Officer, Senior Vice President Corporate Development and Finance, will succeed William Waddill, who is leaving at the end of this month to join a private company. Mr. Patel has been with OncoMed since 2009, most recently as Senior Vice President, Chief Business Officer. In his new role, Mr. Patel will lead finance, administration, corporate development, alliance management and strategic marketing activities.

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