Full Press Release Details
SOUTH PLAINFIELD, N.J. , March 6, 2018 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the fourth quarter and full year ended December 31, 2017 .
"Our mission for the past 20 years has been to develop and bring treatments to patients with rare genetic disorders," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "We are thrilled with the progress we made in 2017. We now have two approved commercial products for patients living with Duchenne muscular dystrophy and have built a global commercial platform. We are also excited with the progress in our splicing platform including the rapidly advancing SMA program. Our commercial success and our developing pipeline positions PTC as a fast-growing, global rare disorder company."
Fourth Quarter and Full Year 2017 Financial Highlights:
Key Fourth Quarter and Full Year 2017 Corporate Highlights:
Non-GAAP Financial Measures: In this press release, the financial results and financial guidance of PTC are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, these 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 financial measures 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 historical and projected operating performance of PTC and the company's future outlook. Quantitative reconciliations of non-GAAP financial measures to their closest equivalent 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 December 31, | Twelve Months Ended December 31, | ||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||
| Revenues: | |||||||||||||
| Net product revenue | $ | 57,953 | $ | 25,119 | $ | 174,066 | $ | 81,447 | |||||
| Collaboration and grant revenue | 20,077 | 72 | 20,326 | 1,258 | |||||||||
| Total revenues | 78,030 | 25,191 | 194,392 | 82,705 | |||||||||
| Operating expenses: | |||||||||||||
| Cost of product sales, excluding amortization of acquired intangible asset | 2,434 | — | 4,577 | — | |||||||||
| Amortization of acquired intangible asset | 5,428 | — | 15,380 | — | |||||||||
| Research and development (1) | 29,234 | 26,011 | 117,456 | 117,633 | |||||||||
| Selling, general and administrative (2) | 35,482 | 24,172 | 121,271 | 97,130 | |||||||||
| Total operating expenses | 72,578 | 50,183 | 258,684 | 214,763 | |||||||||
| Income (loss) from operations | 5,452 | (24,992) | (64,292) | (132,058) | |||||||||
| Interest expense, net | (3,446) | (2,127) | (12,094) | (8,276) | |||||||||
| Other income (expense), net | 93 | 686 | (1,279) | (1,207) | |||||||||
| Income (loss) before income tax expense | 2,099 | (26,433) | (77,665) | (141,541) | |||||||||
| Income tax expense | (829) | (363) | (1,335) | (569) | |||||||||
| Net income (loss) attributable to common stockholders | $ | 1,270 | $ | (26,796) | $ | (79,000) | $ | (142,110) | |||||
| Weighted-average shares outstanding: | |||||||||||||
| Basic (in shares) | 41,344,897 | 34,168,249 | 39,183,073 | 34,044,584 | |||||||||
| Diluted (in shares) | 41,965,276 | 34,168,249 | 39,183,073 | 34,044,584 | |||||||||
| Net income (loss) per share: | |||||||||||||
| Basic (in dollars per share) | $ | 0.03 | $ | (0.78) | $ | (2.02) | $ | (4.17) | |||||
| Diluted (in dollars per share) | $ | 0.03 | $ | (0.78) | $ | (2.02) | $ | (4.17) | |||||
| (1) Research and development reconciliation | |||||||||||||
| GAAP research and development | $ | 29,234 | $ | 26,011 | $ | 117,456 | $ | 117,633 | |||||
| Less: share-based compensation expense | 3,470 | 4,078 | 15,456 | 16,812 | |||||||||
| Less: one-time restructuring cost | — | (5) | — | 840 | |||||||||
| Non-GAAP research and development | $ | 25,764 | $ | 21,938 | $ | 102,000 | $ | 99,981 | |||||
| (2) Selling, general and administrative reconciliation | |||||||||||||
| GAAP selling, general and administrative | $ | 35,483 | $ | 24,172 | $ | 121,271 | $ | 97,130 | |||||
| Less: share-based compensation expense | 3,007 | 4,321 | 15,103 | 18,197 | |||||||||
| Less: one-time restructuring cost | — | (17) | — | 1,644 | |||||||||
| Non-GAAP selling, general and administrative | $ | 32,476 | $ | 19,868 | $ | 106,168 | $ | 77,289 |
| PTC Therapeutics, Inc. | |||||||
| Summary Consolidated Balance Sheets | |||||||
| (In thousands, except per share data) | |||||||
| December 31, 2017 | December 31, 2016 | ||||||
| Cash, cash equivalents and marketable securities | $ | 191,246 | $ | 231,666 | |||
| Total assets | $ | 391,653 | $ | 269,345 | |||
| Total debt | $ | 144,971 | $ | 98,216 | |||
| Total deferred revenue | 11,891 | 1,587 | |||||
| Total liabilities | $ | 235,216 | $ | 149,762 | |||
| Total stockholders' equity (41,612,395 and 34,169,410 common shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively) | 156,437 | 119,583 | |||||
| Total liabilities and stockholders' equity | $ | 391,653 | $ | 269,345 |
| PTC Therapeutics, Inc. | |||||||
| Reconciliation of GAAP to Non-GAAP Projected Full Year 2018 R&D and SG&A Expense (In thousands) | |||||||
| Low End of Range | High End of Range | ||||||
| Projected GAAP R&D and SG&A expense | 280,000 | 290,000 | |||||
| Less: projected R&D and SG&A shared-based compensation expense | 30,000 | 30,000 | |||||
| Total projected non-GAAP R&D and SG&A expense | $ | 250,000 | $ | 260,000 |
Upcoming Events: PTC will participate in the following upcoming investor conferences:
PTC will host an Analyst Day on April 17 th from noon – 5 p.m. ET to provide an update on the company's growing pipeline.
Today's Conference Call and Webcast Reminder Today's conference call will take place at 4:30 p.m. ET and can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 429-97-93. 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 PTC is a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. Founded 20 years ago, PTC Therapeutics' has successfully launched two rare disorder products and has a global commercial footprint. This success is the foundation that drives investment in a robust pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. For more information, 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 contained in this release, other than statements of historic fact, are forward-looking statements, including the information provided under the heading "2018 Guidance", including with respect to (i) 2018 net product revenue and net sales guidance for Translarna and Emflaza and (ii) 2018 GAAP and non-GAAP R&D and SG&A expense guidance, and statements regarding: the future expectations, plans and prospects for PTC; the timing of and likelihood of success of its regulatory path forward in the U.S., including as it relates to any clinical trials and non-clinical studies to generate data on dystrophin production in ataluren, a re-submission of an NDA for ataluren to the FDA, and any further interactions between PTC and the FDA; expansion of Translarna; advancement of PTC's joint collaboration program in SMA; 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: 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 denial to the Complete Response letter it received from the FDA in connection with its NDA for Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD), and PTC's ability to perform additional clinical trials, non-clinical studies, and CMC assessments or analyses at significant cost; 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; 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 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 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 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 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.