Full Press Release Details
SOUTH PLAINFIELD, N.J. , March 16, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2016 .
"For nearly 20 years, PTC has been committed to delivering new treatment options to patients living with Duchenne muscular dystrophy globally," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "Our strong commercial performance in 2016 coupled with the advancements in our clinical programs brings us closer to that goal. I am proud of what we accomplished in 2016, and we will continue to work diligently to bring Translarna to patients globally, as well as develop treatments for additional rare, genetic disorders."
Fourth Quarter and Full Year 2016 Financial Highlights:
Key 2016 Fourth Quarter and other Corporate Highlights:
Non-GAAP Financial Measures
In this press release, PTC's financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial results exclude stock-based compensation expense and one-time restructuring expenses relating to the reorganization of operations intended to improve efficiency and better align costs and employment structure with the Company's strategic plans. These results are provided as a complement to results reported in GAAP, because management uses these non-GAAP financial measures when assessing and identifying operational trends. In management's opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at PTC and the company's future outlook.
| PTC Therapeutics, Inc Consolidated Statements of Operations (In thousands, except per share data) | |||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||
| Revenues: | |||||||||||||
| Net product revenue | $ | 25,119 | $ | 12,694 | $ | 81,447 | $ | 33,696 | |||||
| Collaboration and grant revenue | 72 | 40 | 1,258 | 3,070 | |||||||||
| Total revenues | 25,191 | 12,734 | 82,705 | 36,766 | |||||||||
| Operating expenses: | |||||||||||||
| Research and development (1) | 26,011 | 35,048 | 117,633 | 121,816 | |||||||||
| Selling, general and administrative (2) | 24,172 | 25,887 | 97,130 | 82,080 | |||||||||
| Total operating expenses | 50,183 | 60,935 | 214,763 | 203,896 | |||||||||
| Loss from operations | (24,992) | (48,201) | (132,058) | (167,130) | |||||||||
| Interest expense, net | (2,127) | (2,537) | (8,276) | (2,367) | |||||||||
| Other income (expense), net | 686 | 42 | (1,207) | (465) | |||||||||
| Loss before income tax expense | (26,433) | (50,696) | (141,541) | (169,962) | |||||||||
| Income tax expense | (363) | (252) | (569) | (485) | |||||||||
| Net loss attributable to common stockholders | $ | (26,796) | $ | (50,948) | $ | (142,110) | $ | (170,447) | |||||
| Weighted-average shares outstanding: | |||||||||||||
| Basic and diluted (in shares) | 34,168,249 | 33,915,316 | 34,044,584 | 33,626,248 | |||||||||
| Net loss per share—basic and diluted (in dollars per share) | $ | (0.78) | $ | (1.50) | $ | (4.17) | $ | (5.07) | |||||
| (1) Research and development expense reconciliation | |||||||||||||
| GAAP research and development | $ | 26,011 | $ | 35,048 | $ | 117,633 | $ | 121,816 | |||||
| Less: share-based compensation | 4,078 | 3,686 | 16,812 | 16,138 | |||||||||
| Less: one-time restructuring cost | (5) | — | 840 | — | |||||||||
| Non-GAAP research and development expense | $ | 21,938 | $ | 31,362 | $ | 99,981 | $ | 105,678 | |||||
| (2) Selling, general and administrative expense reconciliation | |||||||||||||
| GAAP selling, general and administrative | $ | 24,172 | $ | 25,887 | $ | 97,130 | $ | 82,080 | |||||
| Less: share-based compensation | 4,321 | 4,163 | 18,197 | 17,841 | |||||||||
| Less: one-time restructuring cost | (17) | — | 1,644 | — | |||||||||
| Non-GAAP selling, general and administrative expense | $ | 19,868 | $ | 21,724 | $ | 77,289 | $ | 64,239 |
| PTC Therapeutics, Inc Summary Consolidated Balance Sheets (In thousands, except per share data) | |||||||
| December 31, 2016 | December 31, 2015 | ||||||
| Cash, cash equivalents and marketable securities | $ | 231,666 | $ | 338,925 | |||
| Total assets | $ | 269,345 | $ | 365,281 | |||
| Total debt | $ | 98,216 | $ | 91,848 | |||
| Total deferred revenue | 1,587 | 139 | |||||
| Total liabilities | $ | 149,762 | $ | 139,280 | |||
| Total stockholders' equity (34,169,410 and 33,916,559 common shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively) | 119,583 | 226,001 | |||||
| Total liabilities and stockholders' equity | $ | 269,345 | $ | 365,281 |
Today's Conference Call and Webcast Reminder
PTC will host a call today at 8:30 am ET , which can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) and providing the passcode 61526711. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com . An accompanying slide presentation will be posted at 8:15 AM on the investor relations section of the PTC website at www.ptcbio.com . A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company's website for two weeks.
About PTC Therapeutics
PTC is a global biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines using our expertise in RNA biology. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders and oncology. PTC has discovered all of its compounds currently under development using its proprietary technologies. Since its founding nearly 20 years ago, PTC' mission has focused on developing treatments to fundamentally change the lives of patients living with rare genetic disorders. The company was founded in 1998 and is headquartered in South Plainfield, New Jersey . For more information on the company, please visit our website www.ptcbio.com .
For More Information:
Investors: Emily Hill + 1 (908) 912-9327 [email protected]
Media: Jane Baj +1 (908) 912-9167 [email protected]
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements, other than those of historical fact, contained in this release are forward-looking statements, including the information provided under the heading "2017 Guidance" and statements regarding: the future expectations, plans and prospects for PTC; the PDUFA date for the NDA; advancement of PTC's joint collaboration program in SMA, including whether and when Sunfish or Firefish may transition into the pivotal part of the applicable study and whether and when a milestone payment to PTC from Roche may be triggered; the closure of extension studies for Translarna for the treatment of nonsense mutation cystic fibrosis; the clinical utility and potential advantages of Translarna (ataluren); advancement of PTC's studies of Translarna for the treatment of other indications; progression of clinical development of PTC596; PTC's expectations with respect to the closing of its planned acquisition of all rights to Emflaza™ (deflazacort), or the "planned acquisition"; PTC's expectations with respect to contingent payments to Marathon based on annual net sales; PTC's strategy, future operations, future financial position, future revenues or projected costs; and the objectives of management. Other forward-looking statements may be identified by the words "look forward", "plan," "anticipate," "believe," "estimate," "expect," "intend," "may," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions.
PTC's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: PTC's ability to resolve the matters set forth in the Refuse to File letter it received from the FDA in connection with its NDA for Translarna for the treatment of nmDMD, including whether PTC's filing of the NDA over protest with the FDA will result in a timely or successful review of the NDA, and whether PTC will be required to perform additional clinical and non-clinical trials or analyses at significant cost, which, if successful, could potentially support the approval of the NDA filed over protest or a new NDA submission; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in the European Economic Area (EEA), including whether the European Medicines Agency (EMA) determines in future annual renewal cycles that the benefit-risk balance of Translarna authorization supports renewal of such authorization; PTC's ability to enroll, fund, complete and timely submit to the EMA the results of Study 041, a randomized, 18-month, placebo-controlled clinical trial of Translarna for the treatment of nmDMD followed by an 18-month open label extension, which is a specific obligation to continued marketing authorization in the EEA; the eligible patient base and commercial potential of Translarna and PTC's other product candidates; the outcome of pricing and reimbursement negotiations in those territories in which PTC may be authorized to sell Translarna for the treatment of nmDMD; the enrollment and conduct of studies under the SMA collaboration and events during, or as a result of, the studies that could delay or prevent further development of RG7916; PTC's scientific approach and general development progress; satisfaction of the conditions to closing the planned acquisition in the anticipated timeframe or at all; PTC's ability to realize the anticipated benefits of the planned acquisition, including the possibility that the expected benefits from the planned acquisition will not be realized or will not be realized within the expected time period; negative effects of the announcement of the planned acquisition on the market price of PTC's common stock; the risk of significant transaction costs, unknown liabilities, and litigation and/or regulatory actions related to the planned acquisition; the sufficiency of PTC's cash resources and its ability to obtain adequate financing in the future for its foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the "Risk Factors" section of PTC's most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K as well as any updates to these risk factors filed from time to time in PTC's other filings with the SEC. You are urged to carefully consider all such factors.
As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that Translarna will receive full regulatory approval in any territory or maintain its current marketing authorization for Translarna for the treatment of nmDMD in the EEA, or prove to be commercially successful in general, or specifically with respect to the treatment of nmDMD.
The forward-looking statements contained herein represent PTC's views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.
SOURCE PTC Therapeutics, Inc.