SAN DIEGO, Aug. 29, 2014 /PRNewswire/ -- Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage biotechnology company engaged in the development of high-value and difficult to manufacture proteins including biosimilar therapeutics, today provided a business update and reported financial results for the second quarter ended June 30, 2014.
"With the successful completion of our initial public offering, we have the capital to continue to advance our biosimilar product candidates, derived from our proprietary protein expression platform," stated Bertrand C. Liang, chief executive officer of Pfenex. "We expect to complete the phase 1b/2a trial for our lead product candidate, PF582, a biosimilar to Lucentis, by the end of 2014 and initiate the phase 3 trial in mid-2015."
Financial Highlights for the three months ended June 30, 2014
Forward-Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or Pfenex's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to, Pfenex's expectations regarding the development pathway, timing and success of its clinical trials for PF582 and its other product candidates. The Company's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Pfenex's ability to successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Pfenex's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, Pfenex's ability to manage operating expenses, Pfenex's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Pfenex's dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in the final prospectus related to Pfenex's initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as discussions of potential risks, uncertainties, and other important factors in Pfenex's subsequent filings with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Pfenex as of the date hereof, and Pfenex disclaims any obligation to update any forward-looking statements, except as required by law.
About Pfenex Inc.Pfenex Inc. is a clinical-stage biotechnology company engaged in the development of high-value and difficult to manufacture proteins including biosimilar therapeutics. The company's lead product candidate is PF582, a biosimilar candidate to Lucentis (ranibizumab), for the potential treatment of patients with retinal diseases. Pfenex has leveraged its Pfēnex Expression Technology™ platform to build a pipeline of product candidates and preclinical products under development including other biosimilars, as well as vaccines, generics and next generation biologics.Pfenex has used, and intends to continue to use, its Investor Relations website (http://pfenex.investorroom.com), as means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, including a copy of our Corporate Presentation dated August 2014, visit (http://pfenex.investorroom.com).
Pfenex, Inc.Condensed Statement of Operations(in thousands, except per share data)(Unaudited)Three Months EndedJune 30,Six Months EndedJune 30, 2014201320142013Revenue$
5,694Cost of revenue2,5441,3064,4523,335Gross Profit7221,0031,3722,359Operating expenses:Selling, general and administrative2,0241,6763,5193,459Research and development8601,2721,5382,052Total operating expenses2,8842,9485,0575,511Loss from operations(2,162)(1,945)(3,685)(3,152)Other expense, net(21)(9)(39)(10)Net loss before income taxes(2,183)(1,954)(3,724)(3,162)Income tax benefit (expense)-777(1)1,259Net loss$
(3,725)$ (1,903)Effective preferred stock dividends$
(827)Net loss attributable to common stockholders$
(4,607)$ (2,730)Net loss per common share basic and diluted$
(1.80)Weighted-average common shares used to compute basic and diluted net loss per share1,5711,5421,5601,520
Pfenex, Inc.Balance Sheets(In thousands, except share and par value amounts)(Unaudited)June 30, 2014December 31, 2013AssetsCurrent assets:Cash and cash equivalents$
3,954Short-term investments-1,250Accounts and unbilled receivables, net1,3553,461Inventories finished goods1826Income tax receivable401398Deferred income taxes3,4813,481Other current assets1,519284Total current assets10,71512,854Restricted cash4,0304,029Property and equipment, net2,1022,329Notes receivable from related parties-95Other long term assets3636Intangible assets, net6,6286,893Goodwill5,5775,577Total assets$
31,813Liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)Current liabilities:Accounts payable$
,804Accrued liabilities4,5702,953Deferred revenue9971,253Line of credit obligation3,813-Total current liabilities10,5076,010Deferred tax liability3,4813,481Line of credit obligation-3,590Other long-term liabilities33Total liabilities13,99113,084Commitments and contingencies (Notes 9 and 10)Redeemable convertible Series A-2 preferred stock, par value $0.001,5,000,000 and 4,978,662 shares authorized at June 30, 2014 and December 31, 2013, respectively; 3,556,186 shares issued andoutstanding; $13,815,111 liquidation preference49,40049,200Redeemable convertible Series A-1 preferred stock, par value $0.001,5,000,000 and 4,978,662 shares authorized at June 30, 2014 and December 31, 2013, respectively;, 4,978,661 shares issued andoutstanding; $16,470,071 liquidation preference64,54063,980Stockholders' equity (deficit):Common stock, $.001 par value, 30,000,000 and 12,514,224 shares authorized at June 30, 2014 and December 31, 2013, respectively; 1,571,473 and 1,541,781 shares issued and outstanding at June 30, 2014 and December 31, 2013, respectively42Additional paid-in capital--Accumulated deficit(98,847)(94,453)Total stockholders' equity (deficit)(98,843)(94,451)Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)$
31,813Note: The Pfenex Condensed Statement of Operations and Balance Sheet for the period ended June 30, 2014 does not reflect the Pfenex initial public offering that closed on July 29, 2014.
|SOURCE Pfenex Inc.|
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