- Based on a full review of the data from the Phase 3 VELOCITY trial, feedback from the FDA during the development of somavaratan, and an objective assessment by external regulatory experts, the company believes it could not successfully file for approval based on the existing dataset.
- All current clinical trials of somavaratan have been concluded and the U.S. Investigational New Drug Application (IND) and equivalent filings in other countries have been withdrawn. Additionally, in January 2018, Teijin Limited (Teijin) terminated its license agreement for somavaratan in Japan following its evaluation of the VELOCITY trial results.
- The investment and delay in time-to-market that further development would require significantly impact the business case for somavaratan, given the potential that one or more long-acting growth hormone products may already be commercialized for pediatric growth hormone deficiency during that time.
- The company is focused on evaluating strategic opportunities to leverage its expertise and resources to create value for shareholders. Cowen is assisting the company in reviewing possible transactions, including strategic combinations and opportunities to diversify the Versartis pipeline.
Total operating expenses for the quarter ended December 31, 2017 were $8.9 million compared to $22.5 million for the quarter ended December 31, 2016. Research and development (R&D) expenses for the quarter ended December 31, 2017 were $1.3 million, compared to $16.7 million for the quarter ended December 31, 2016. The decrease in R&D expenses was primarily due to the termination of clinical and manufacturing related contracts that supported the company's Phase 3 clinical trials for somavaratan. These cost savings were partially offset by severance expenses associated with our reduction in workforce, as a result of the failure of the Phase 3 VELOCITY trial to meet its primary endpoint.General and administrative (G&A) expenses were $7.6 million for the quarter ended December 31, 2017, compared to $5.8 million for the quarter ended December 31, 2016. The increase in G&A expenses was primarily due to severance expenses in connection with our reduction in workforce. Total operating expenses for the year ended December 31, 2017 were $124.5 million compared to $96.3 million for the year ended December 31, 2016. R&D expenses for the year ended December 31, 2017 were $94.6 million, compared to $72.0 million for the year ended December 31, 2016. The increase in R&D expenses was primarily due to clinical and manufacturing related costs to support the global VELOCITY pediatric trial and the Phase 2/3 trial of somavaratan in pediatric patients in Japan. G&A expenses were $29.9 million for the year ended December 31, 2017, compared to $24.3 million for the year ended December 31, 2016. The increase in G&A expenses was primarily due to additional payroll and fees related to consulting and professional services to support our overall growth prior to the failure of the Phase 3 VELOCITY trial to meet its primary endpoint. Total operating expenses for the quarter ended December 31, 2017 include non-cash stock-based compensation expense of $2.2 million compared to $2.9 million of non-cash stock-based compensation expense for the quarter ended December 31, 2016. Total operating expenses for the year ended December 31, 2017 include non-cash stock-based compensation expense of $13.3 million, compared to $10.9 million of non-cash stock-based compensation expense for the year ended December 31, 2016.
Cash, cash equivalents, and short-term investments were $81.1 million as of December 31, 2017.Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things the potential for additional development, eventual regulatory approval and commercialization of somavaratan; the possibility of diversifying our pipeline by licensing or otherwise acquiring additional product candidates; and the potential for a strategic transaction with another public or private company with complementary assets and expertise. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risk that we will not be able to identify appropriate strategic opportunities or that such opportunities or transactions will not create value for our shareholders, and our ability or inability to continue with the development and commercialization of somavaratan in the future. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release due to inherent risks and uncertainties involved in our business. We discuss many of these risks in greater detail under the heading "Risk Factors" contained in our Annual Report on Form 10-K for the year ended December 31, 2016 and in our Quarterly Report on Form 10-Q for the three months ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC), and in our other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contacts:Kevin HaasVP, Finance(650) 963-8595 firstname.lastname@example.org
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Research and development||1,317||16,731||94,612||71,984|
|General and administrative||7,569||5,760||29,870||24,336|
|Total operating expenses||8,886||22,491||124,482||96,320|
|Income (loss) from operations||31,114||(22,491||)||(84,482||)||(96,320||)|
|Other income (expense), net||(547||)||446||(1,591||)||236|
|Net income (loss) before provision for income taxes||30,753||(21,885||)||(85,226||)||(95,570||)|
|Provision for (benefit from) income taxes||(375||)||247||(247||)||247|
|Net income (loss)||$||31,128||$||(22,132||)||$||(84,979||)||$||(95,817||)|
|Net income (loss) per share- basic||$||0.87||$||(0.64||)||$||(2.41||)||$||(3.11||)|
|Net income (loss) per share- diluted||$||0.87||$||(0.64||)||$||(2.41||)||$||(3.11||)|
|Weighted-average common shares used to compute basic net income (loss) per share||35,872||34,609||35,228||30,784|
|Weighted-average common shares used to compute diluted net income (loss) per share||35,901||34,609||35,228||30,784|
|December 31,||December 31,|
|Cash and cash equivalents||$||81,146||$||201,153|
|Build-to-suit lease asset||8,888||—|
|Liabilities and stockholders' equity:|
|Accounts payable and other current liabilities||$||5,593||$||14,503|
|Build-to-suit lease obligation||5,428||—|
|Upfront payment from collaboration partner||—||40,000|
|Total stockholders' equity||82,756||151,067|
|Total liabilities and stockholders ' equity||$||93,777||$||205,570|