Full Press Release Details
PTC Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides a Corporate Update
SOUTH PLAINFIELD, N.J. March 2, 2020 - PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the fourth quarter and full year ending December 31, 2019.
"2019 was a year of outstanding execution for PTC. I'm proud of the progress made in every area of the business," said Stuart Peltz, Ph.D., CEO of PTC Therapeutics. "We've significantly expanded our rare disease portfolio, strengthened our global commercial engine and added vital gene therapy manufacturing capabilities, all while delivering on our revenue guidance. The innovation in our diverse, multiplatform pipeline continues to create value for stakeholders."
Key Fourth Quarter and Other Corporate Highlights:
Expanding commercial footprint including continued revenue growth
Positive pivotal trials for risdiplam support planned global launch in broad range of SMA patient types
PTC gene therapy platform continues to make progress with regulatory filings and long-term lease of manufacturing facility
Continued progress with PTC's multi-platform, multi-product pipeline
Fourth Quarter and Full-year 2019 Financial Highlights:
PTC Reaffirms Full Year 2020 Guidance as Follows
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 non-cash, stock-based compensation expense. 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. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. Quantitative reconciliations of the non-GAAP financial measures to their respective closest equivalent GAAP financial measures are included in the table below.
| PTC Therapeutics, Inc. Consolidated Statements of Operations (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Revenues: | ||||||||||||||||
| Net product revenue | $ | 81,407 | $ | 85,833 | $ | 291,306 | $ | 263,005 | ||||||||
| Collaboration and grant revenue | 15,052 | 505 | 15,674 | 1,729 | ||||||||||||
| Total revenues | 96,459 | 86,338 | 306,980 | 264,734 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of product sales | 3,542 | 3,761 | 12,135 | 12,670 | ||||||||||||
| Amortization of acquired intangible asset | 7,973 | 6,062 | 27,650 | 22,877 | ||||||||||||
| Research and development (1) | 81,831 | 53,647 | 257,452 | 171,984 | ||||||||||||
| Selling, general and administrative (2) | 63,497 | 48,666 | 202,541 | 153,548 | ||||||||||||
| Change in the fair value of deferred and contingent consideration | 12,400 | 19,340 | 48,360 | 19,340 | ||||||||||||
| Total operating expenses | 169,243 | 131,476 | 548,138 | 380,419 | ||||||||||||
| Loss from operations | (72,784 | ) | (45,138 | ) | (241,158 | ) | (115,685 | ) | ||||||||
| Interest expense, net | (5,463 | ) | (3,248 | ) | (12,491 | ) | (12,554 | ) | ||||||||
| Other expense (income), net | 11,214 | (937 | ) | 13,723 | 129 | |||||||||||
| Loss before income tax expense | (67,033 | ) | (49,323 | ) | (239,926 | ) | (128,110 | ) | ||||||||
| Income tax (expense) benefit | (10,644 | ) | 993 | (11,650 | ) | 29 | ||||||||||
| Net loss attributable to common stockholders | $ | (77,677 | ) | $ | (48,330 | ) | $ | (251,576 | ) | $ | (128,081 | ) | ||||
| Weighted-average shares outstanding: | ||||||||||||||||
| Basic and diluted (in shares) | 56,570,002 | 50,331,914 | 58,863,185 | 46,576,313 | ||||||||||||
| Net loss per share-basic and diluted (in dollars per share) | $ | (1.37 | ) | $ | (0.96 | ) | $ | (4.27 | ) | $ | (2.75 | ) | ||||
| (1) Research and development reconciliation | ||||||||||||||||
| GAAP research and development | $ | 81,831 | $ | 53,647 | $ | 257,452 | $ | 171,984 | ||||||||
| Less: share-based compensation expense | 5,645 | 3,986 | 20,836 | 16,096 | ||||||||||||
| Non-GAAP research and development | $ | 76,186 | $ | 49,661 | $ | 236,616 | $ | 155,888 | ||||||||
| (2) Selling, general and administrative reconciliation | ||||||||||||||||
| GAAP selling, general and administrative | $ | 63,497 | $ | 48,666 | $ | 202,541 | $ | 153,548 | ||||||||
| Less: share-based compensation expense | 5,821 | 4,492 | 21,298 | 17,156 | ||||||||||||
| Non-GAAP selling, general and administrative | $ | 57,676 | $ | 44,174 | $ | 181,243 | $ | 136,392 |
| PTC Therapeutics, Inc. Summary Consolidated Balance Sheets (in thousands, except share data) | ||||||||
| December 31, 2019 | December 31, 2018 | |||||||
| Cash, cash equivalents and marketable securities | $ | 686,563 | $ | 227,586 | ||||
| Total Assets | $ | 1,623,782 | $ | 1,119,222 | ||||
| Total debt | $ | 313,859 | $ | 153,014 | ||||
| Total deferred revenue | 11,657 | 13,438 | ||||||
| Total liabilities | $ | 1,029,452 | $ | 768,495 | ||||
| Total stockholders' equity (61,935,870 and 50,606,147 common shares issued and outstanding at December 31, 2019 and December 31, 2018 respectively) | $ | 594,330 | $ | 350,727 | ||||
| Total liabilities and stockholders' equity | $ | 1,623,782 | $ | 1,119,222 |
| PTC Therapeutics, Inc. Reconciliation of GAAP to Non-GAAP Projected Full Year 2020 R&D and SG&A Expense (In thousands) | ||||||||
| Low End of Range | High End of Range | |||||||
| Projected GAAP R&D and SG&A Expense | $ | 610,000 | $ | 640,000 | ||||
| Less: projected non-cash, stock-based compensation expense | 65,000 | 65,000 | ||||||
| Projected non-GAAP R&D and SG&A expense | $ | 545,000 | $ | 575,000 |
Today's Conference Call and Webcast Reminder:
Today's conference call will take place at 4:30 pm 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 1732477. 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 30 days following the call.
About PTC Therapeutics, Inc.
PTC is a science-driven, global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to patients with rare disorders. PTC's ability to globally commercialize products is the foundation that drives investment in a robust and diversified 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:
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 "Full Year 2020 Guidance", including with respect to (i) 2020 net product revenue guidance and (ii) 2020 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 gene therapy platform, including any potential regulatory submissions and manufacturing capabilities; advancement of PTC's joint collaboration program in SMA, including any potential regulatory submissions, commercialization or royalty or milestone payments; PTC's expectations with respect to the licensing, regulatory submissions and commercialization of its products and product candidates; PTC's strategy, future operations, future financial position, future revenues, 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 PTC's products or product candidates that PTC commercializes or may commercialize in the future; expectations with respect to PTC's gene therapy platform, including any potential regulatory submissions and potential approvals, manufacturing capabilities and the potential financial impact and benefits of its leased biologics manufacturing facility and the potential achievement of development, regulatory and sales milestones and contingent payments that PTC may be obligated to make; 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, including any potential regulatory submissions and potential commercialization with regards to risdiplam; PTC's ability to complete a dystrophin study necessary to support a re-submission of its Translarna NDA for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) to the FDA, and PTC's ability to perform any necessary 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 commercialization of Tegsedi and Waylivra; significant 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 PTC's products and product candidates; PTC's scientific approach and general development progress; PTC's ability to satisfy its obligations under the terms of the lease agreement for its leased biologics manufacturing facility; 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 and 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, Emflaza, PTC-AADC, Tegsedi, Waylivra or risdiplam.
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.