Translarna net product sales were $32.0 million for the third quarter of 2017, representing 45% growth over $22.0 million reported in the third quarter of 2016.
- Total third quarter revenue of $41.9M representing 82% growth over 3Q2016 -
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| [02-November-2017] |
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SOUTH PLAINFIELD, N.J., Nov. 2, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the third quarter ending September 30, 2017. "Our performance this quarter combined with our commercial, financial and R&D advancements should allow us to end 2017 in a strong position," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "Our commercial success is driven by our mission of improving the lives of patients with Duchenne." Third Quarter Financial Highlights:
2017 Guidance:
Key Third Quarter and other Corporate Highlights:
Non-GAAP Financial Measures:
PTC Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
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2017 2016 2017 2016
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Revenues:
Net product revenue $41,780 $22,013 $116,113 $56,328
Collaboration and grant revenue 73 973 249 1,186
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Total revenues 41,853 22,986 116,362 57,514
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Operating expenses:
Cost of product sales, excluding amortization of acquired intangible asset 1,582 - 2,142 -
Amortization of acquired intangible asset 9,716 - 9,952 -
Research and development (1) 30,024 31,396 88,222 91,622
Selling, general and administrative (2) 31,423 23,654 85,788 72,958
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Total operating expenses 72,745 55,050 186,104 164,580
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Loss from operations (30,892) (32,064) (69,742) (107,066)
Interest expense, net (3,421) (2,133) (8,648) (6,149)
Other income (expense), net 766 (786) (1,373) (1,893)
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Loss before income tax expense (33,547) (34,983) (79,763) (115,108)
Income tax expense (191) (184) (507) (206)
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Net loss attributable to common stockholders $(33,738) $(35,167) $(80,270) $(115,314)
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Weighted-average shares outstanding:
Basic and diluted (in shares) 41,296,740 34,088,741 38,433,749 34,002,952
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Net loss per share-basic and diluted (in dollars per share) $(0.82) $(1.03) $(2.09) $(3.39)
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(1) Research and development reconciliation
GAAP research and development $30,024 $31,396 $88,222 $91,622
Less: share-based compensation expense 3,624 4,319 11,986 12,734
Less: one-time restructuring cost - 5 - 845
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Non-GAAP research and development $26,400 $27,072 $76,236 $78,043
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(2) Selling, general and administrative reconciliation
GAAP selling, general and administrative $31,423 $23,654 $85,788 $72,958
Less: share-based compensation expense 3,544 4,640 12,096 13,876
Less: one-time restructuring cost - 28 - 1,661
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Non-GAAP selling, general and administrative $27,879 $18,986 $73,692 $57,421
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PTC Therapeutics, Inc.
Summary Consolidated Balance Sheets
(In thousands, except per share data)
September 30, December 31,
2017 2016
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Cash, cash equivalents and marketable securities $169,310 $231,666
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Total assets $367,720 $269,345
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Total debt $143,091 $98,216
Total deferred revenue 12,701 1,587
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Total liabilities $221,838 $149,762
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Total stockholders' equity (41,463,121 and 34,169,410 common shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively) 145,882 119,583
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Total liabilities and stockholders' equity $367,720 $269,345
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PTC Therapeutics, Inc.
Reconciliation of GAAP to Non-GAAP Full Year 2017 R&D and SG&A Expense
(In thousands, except per share data)
Low End of High End
Range of Range
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Projected GAAP R&D
and SG&A expense 250,000 260,000
Less: projected
shared-based
compensation
expense 40,000 40,000
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Total projected
non-GAAP R&D and
SG&A expense $210,000 $220,000
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Today's Conference Call and Webcast Reminder About PTC Therapeutics For More Information: Media: Forward Looking Statements: 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 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 Complete Response letter it received from the FDA in connection with its NDA for Translarna for the treatment of nmDMD either via outcome of any formal dispute resolution request or other interactions with the FDA, 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; 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 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. View original content:http://www.prnewswire.com/news-releases/ptc-therapeutics-reports-third-quarter-2017-financial-results-and-provides-corporate-update-300548825.html SOURCE PTC Therapeutics, Inc. |
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Company Codes: NASDAQ-NMS:PTCT |
