Full Press Release Details
SOUTH PLAINFIELD, N.J. , May 8, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the first quarter ending March 31, 2017 .
"We are thrilled to bring EMFLAZA to Duchenne muscular dystrophy patients in the United States ," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "The acquisition of EMFLAZA supports our commitment to providing new treatment options for Duchenne patients. We plan to launch EMFLAZA in the coming weeks and are focused on providing access to all eligible patients. We are also pleased with Translarna's continued sales growth outside the U.S. with another strong quarter. With Translarna and EMFLAZA, we now have two of the three approved Duchenne drugs globally."
First Quarter Financial Highlights:
Key First 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 measures 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 PTC's strategic plans. These non-GAAP financial measures 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 financial measures are useful to investors and other users of PTC's financial statements by providing greater transparency into the operating performance at PTC and the company's future outlook. Quantitative reconciliations of GAAP financial measures are included in the tables below.
| PTC Therapeutics, Inc. Consolidated Statements of Operations (In thousands, except per share data) | |||||||
| Three Months Ended March 31, | |||||||
| 2017 | 2016 | ||||||
| Revenues: | |||||||
| Net product revenue................................................................................. | $ | 26,442 | $ | 18,878 | |||
| Collaboration and grant revenue.............................................................. | 105 | 17 | |||||
| Total revenues.............................................................................................. | 26,547 | 18,895 | |||||
| Operating expenses: | |||||||
| Cost of product sales............................................................................... | 39 | — | |||||
| Research and development (1)............................................................... | 27,363 | 31,399 | |||||
| Selling, general and administrative (2).................................................... | 25,500 | 25,938 | |||||
| Total operating expenses............................................................................. | 52,902 | 57,337 | |||||
| Loss from operations................................................................................... | (26,355) | (38,442) | |||||
| Interest expense, net................................................................................... | (2,219) | (1,956) | |||||
| Other expense, net...................................................................................... | (318) | (721) | |||||
| Loss before income tax expense................................................................. | (28,892) | (41,119) | |||||
| Income tax expense...................................................................................... | (165) | (114) | |||||
| Net loss attributable to common stockholders.......................................... | $ | (29,057) | $ | (41,233) | |||
| Weighted-average shares outstanding: | |||||||
| Basic and diluted (in shares).................................................................... | 34,305,948 | 33,919,169 | |||||
| Net loss per share—basic and diluted (in dollars per share)....................... | $ | (0.85) | $ | (1.22) | |||
| (1) Research and development expense reconciliation | |||||||
| GAAP research and development | $ | 27,363 | $ | 31,399 | |||
| Less: share-based compensation | 4,467 | 4,328 | |||||
| Less: one-time restructuring cost | — | 716 | |||||
| Non-GAAP research and development expense | $ | 22,896 | $ | 26,355 | |||
| (2) Selling, general and administrative expense reconciliation | |||||||
| GAAP selling, general and administrative | $ | 25,500 | $ | 25,938 | |||
| Less: share-based compensation | 4,562 | 4,587 | |||||
| Less: one-time restructuring cost | — | 1,187 | |||||
| Non-GAAP selling, general and administrative expense | $ | 20,938 | $ | 20,164 |
| PTC Therapeutics, Inc. Summary Consolidated Balance Sheets (In thousands, except per share data) | |||||||
| March 31, 2017 | December 31, 2016 | ||||||
| Cash, cash equivalents and marketable securities............................................ | $ | 202,577 | $ | 231,666 | |||
| Total assets ..................................................................................................... | $ | 248,645 | $ | 269,345 | |||
| Total debt............................................................................................................ | $ | 99,895 | $ | 98,216 | |||
| Total deferred revenue....................................................................................... | 2,194 | 1,587 | |||||
| Total liabilities ................................................................................................. | $ | 147,818 | $ | 149,762 | |||
| Total stockholders' equity (34,316,836 and 34,169,410 common shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively)...................................................................................................... | 100,827 | 119,583 | |||||
| Total liabilities and stockholders' equity .................................................. | $ | 248,645 | $ | 269,345 |
Today's Conference Call and Webcast Reminder Today's conference call will take place at 8:30 AM (ET) and can be access by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 11527010. 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 . 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, Inc. 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's 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]
About MidCap Financial
MidCap Financial is a middle market-focused, specialty finance firm that provides senior debt solutions to businesses across all industries. Its debt solutions include general and healthcare asset-based working capital loans, leveraged loans to private equity-backed companies, life sciences loans to VC-backed and public companies, commercial real estate loans, and lender finance loans.
Additional information about MidCap Financial can be found at www.midcapfinancial.com
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; timing of the pending commercial launch in the U.S. of EMFLAZA for the treatment of DMD; the size of the DMD patient population eligible for EMFLAZA treatment in the U.S.; 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; 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 "guidance", "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 preparations for a commercial launch of EMFLAZA in the U.S., including its ability to finalize in a timely manner regulatory, distribution and commercial matters that must be concluded prior to a launch by PTC; PTC's ability to realize the anticipated benefits of the acquisition of EMFLAZA, including the possibility that the expected benefits from the acquisition will not be realized or will not be realized within the expected time period; significant transaction costs, unknown liabilities, the risk of litigation and/or regulatory actions related to the acquisition of EMFLAZA, as well as other business effects, including the effects of industry, market, economic, political or regulatory conditions; changes in tax and other laws, regulations, rates and policies; the outcome of pricing, coverage and reimbursement negotiations with third party payors for EMFLAZA and Translarna; whether, and to what extent, third party payors impose additional requirements before approving EMFLAZA prescription reimbursement; 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, EMFLAZA and PTC's other product candidates; 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 under the program; PTC's scientific approach and general development progress; PTC's ability to satisfy its obligations under the terms of the senior secured term loan facility with MidCap Financial; 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 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 any product will receive or maintain regulatory approval in any territory, or prove to be commercially successful, including Translarna or EMFLAZA.
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.