Full Press Release Details
SOUTH PLAINFIELD, N.J. , Nov. 5, 2018 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the third quarter ending September 30, 2018 .
"We have been aggressively pursuing our vision to build a leading, fully integrated, multiplatform biotech company," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "The addition of gene therapy aligns with our goal of developing treatments for more patients with rare disorders and the in-licensing of Tegsedi™ and Waylivra™ leverages our commercial expertise. Over the last 20 years, our desire to bring new therapeutics to patients has been based on scientific innovation and we are continuing that mission."
Third Quarter Financial Highlights:
Key Third Quarter and Other 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, the non-GAAP financial measures exclude stock-based compensation expense. This non-GAAP financial measure is provided as a complement to financial measures reported in GAAP because management uses this non-GAAP financial measure when assessing and identifying operational trends. In management's opinion, this non-GAAP financial measure is 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.
Today's Conference Call and Webcast Reminder: Today's conference call will take place at 4:30 pm 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 2477754. 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 . The accompanying slide presentation will be posted on the investor relations section of the PTC website. 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 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: 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; expectations with respect to PTC's recently acquired gene therapy platform, including any potential regulatory submissions; PTC's expectations with respect to the licensing and potential commercialization of Tegsedi and Waylivra; expansion of commercialization of Translarna and Emflaza; advancement of PTC's joint collaboration program in SMA; PTC's strategy, future operations, future financial position, future revenues, projected costs; or intended use of proceeds from its public offering of common stock; 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 and any other product candidates for which PTC may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving Emflaza prescription reimbursement; PTC's ability to complete any dystrophin study necessary in order to resolve the matters set forth in the denial to the Complete Response letter it received from the FDA in connection with its new drug application 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; expectations with respect to the potential financial impact or PTC's ability to realize the anticipated benefits of the acquisition of Agilis and its gene therapy platform, including with respect to the business of Agilis and expectations with respect to the potential achievement of development, regulatory and sales milestones and contingent payments to the former Agilis equityholders with respect thereto and PTC's ability to obtain marketing approval of PTC-AADC and other product candidates acquired from Agilis, will not be realized or will not be realized within the expected time period; expectations with respect to the potential financial impact and benefits of the collaboration and licensing agreement with Akcea Therapeutics, Inc., including with respect to the timing of regulatory approval of Tegsedi and Waylivra in countries in LATAM and the Caribbean , the commercialization of Tegsedi and Waylivra, and PTC's expectations with respect to contingent payments to Akcea based on net sales and the potential achievement of regulatory milestones; 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 or the acquisition of its gene therapy pipeline, 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, PTC-AADC, Tegsedi, Waylivra or any of PTC's other product candidates; the enrollment, conduct, and results 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 Annual Report on Form 10-K for the year ended December 31, 2017 , Quarterly Reports on Form 10-Q for the periods ended March 31, 2018 , June 30, 2018 and September 30, 2018 and Exhibit 99.2 to PTC's Current Report on Form 8-K filed on August 24, 2018 , 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, Emflaza, PTC-AADC, Tegsedi or Waylivra.
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.
| PTC Therapeutics, Inc Consolidated Statements of Operations (In thousands, except per share data) | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| Revenues: | |||||||||||||
| Net product revenue | $ | 53,021 | $ | 41,780 | $ | 177,172 | $ | 116,113 | |||||
| Collaboration and grant revenue | 570 | 73 | 1,224 | 249 | |||||||||
| Total revenues | 53,591 | 41,853 | 178,396 | 116,362 | |||||||||
| Operating expenses: | |||||||||||||
| Cost of product sales | 3,292 | 1,582 | 8,909 | 2,142 | |||||||||
| Amortization of Acquired intangible asset | 5,793 | 9,716 | 16,815 | 9,952 | |||||||||
| Research and development (1) | 54,368 | 30,024 | 118,337 | 88,222 | |||||||||
| Selling, general and administrative (2) | 38,368 | 31,423 | 104,882 | 85,788 | |||||||||
| Total operating expenses | 101,821 | 72,745 | 248,943 | 186,104 | |||||||||
| Loss from operations | (48,230) | (30,892) | (70,547) | (69,742) | |||||||||
| Interest expense, net | (3,118) | (3,421) | (9,306) | (8,648) | |||||||||
| Other income (expense), net | 734 | 766 | 1,066 | (1,373) | |||||||||
| Loss before income tax expense | (50,614) | (33,547) | (78,787) | (79,763) | |||||||||
| Income tax expense | (355) | (191) | (964) | (507) | |||||||||
| Net loss attributable to common stockholders | $ | (50,969) | $ | (33,738) | $ | (79,751) | $ | (80,270) | |||||
| Weighted-average shares outstanding: | |||||||||||||
| Basic and diluted (in shares) | 48,096,521 | 41,296,740 | 45,310,690 | 38,433,749 | |||||||||
| Net loss per share—basic and diluted (in dollars per share) | $ | (1.06) | $ | (0.82) | $ | (1.76) | $ | (2.09) | |||||
| (1) Research and development reconciliation | |||||||||||||
| GAAP research and development | $ | 54,368 | $ | 30,024 | $ | 118,337 | $ | 88,222 | |||||
| Less: share-based compensation expense | 4,431 | 3,624 | 12,109 | 11,986 | |||||||||
| Non-GAAP research and development | $ | 49,937 | $ | 26,400 | $ | 106,228 | $ | 76,236 | |||||
| (2) Selling, general and administrative reconciliation | |||||||||||||
| GAAP selling, general and administrative | $ | 38,368 | $ | 31,423 | $ | 104,882 | $ | 85,788 | |||||
| Less: share-based compensation expense | 4,511 | 3,544 | 12,664 | 12,096 | |||||||||
| Non-GAAP selling, general and administrative | $ | 33,857 | $ | 27,879 | $ | 92,218 | $ | 73,692 |
| PTC Therapeutics, Inc Summary Consolidated Balance Sheets (In thousands, except per share data) | |||||||
| September 30, 2018 | December 31, 2017 | ||||||
| Cash, cash equivalents and marketable securities | $ | 249,404 | $ | 191,246 | |||
| Total assets | $ | 1,028,627 | $ | 391,653 | |||
| Total debt | $ | 150,925 | $ | 144,971 | |||
| Total deferred revenue | 13,160 | 11,891 | |||||
| Total liabilities | $ | 642,537 | $ | 235,216 | |||
| Total stockholders' equity (50,432,655 and 41,612,395 common shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively) | 386,090 | 156,437 | |||||
| Total liabilities and stockholders' equity | $ | 1,028,627 | $ | 391,653 |
| PTC Therapeutics, Inc Reconciliation of GAAP to Non-GAAP Projected Full Year R&D and SG&A (In thousands) | |||||||
| Low End of Range | High End of Range | ||||||
| Projected GAAP R&D and SG&A expense | $ | 315,000 | $ | 325,000 | |||
| Less: projected shared-based compensation expense | 35,000 | 35,000 | |||||
| Total projected non-GAAP R&D and SG&A expense | $ | 280,000 | $ | 290,000 |
SOURCE PTC Therapeutics, Inc.