Full Press Release Details
SOUTH PLAINFIELD, N.J. , Aug. 7, 2018 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT ) today announced a corporate update and reported financial results for the second quarter ending June 30, 2018 .
"We have made significant progress towards delivering on our strategic plan this year," said Stuart W. Peltz , Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "This includes furthering our underlying business as well as executing on two external transactions. We look forward to bringing value to both patients and shareholders with the acquisition of Agilis, the LATAM commercialization rights for Tegsedi™ and Waylivra™ and realizing additional growth in the second half of the year."
Second Quarter Financial Highlights:
Key Second 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 8284468. A live, listen-only webcast of the conference call and corresponding slides 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. PTC's current Investor Presentation and R&D Day slides are available at the same website location.
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, please visit our website at 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; our expectations with respect to the closing of our planned acquisition of Agilis Biotherapeutics, Inc. and potential subsequent regulatory submissions of any product candidates acquired upon closing; our 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; 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 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 expectations with respect to the closing of its planned acquisition of Agilis, and the other transactions contemplated in conjunction with the acquisition, including with respect to matters of timing, including the satisfaction of closing conditions, the anticipated financial impact and potential benefits to PTC, integration of Agilis into PTC's business and any product candidates PTC may acquire from Agilis into its business strategy assuming completion of the acquisition and other matters related to the acquisition; 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 planned acquisition of Agilis, 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, Tegsedi, Waylivra, PTC's other product candidates and any product candidates PTC may acquire upon completion of our planned acquisition of Agilis; 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 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, 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 June 30, | Six Months Ended June 30, | ||||||||||||
| 2018 | 2017 | 2018 | 2017 | ||||||||||
| Revenues: | |||||||||||||
| Net product revenue | $ | 68,170 | $ | 47,891 | $ | 124,151 | $ | 74,334 | |||||
| Collaboration and grant revenue | 573 | 71 | 654 | 176 | |||||||||
| Total revenues | 68,743 | 47,962 | 124,805 | 74,510 | |||||||||
| Operating expenses: | |||||||||||||
| Cost of product sales | 2,572 | 758 | 5,616 | 797 | |||||||||
| Amortization of Acquired intangible asset | 5,593 | - | 11,022 | - | |||||||||
| Research and development (1) | 32,607 | 30,835 | 63,970 | 58,198 | |||||||||
| Selling, general and administrative (2) | 33,545 | 28,866 | 66,514 | 54,365 | |||||||||
| Total operating expenses | 74,317 | 60,459 | 147,122 | 113,360 | |||||||||
| Loss from operations | (5,574) | (12,497) | (22,317) | (38,850) | |||||||||
| Interest expense, net | (2,884) | (3,008) | (6,187) | (5,227) | |||||||||
| Other (expense) income, net | (673) | (1,820) | 332 | (2,139) | |||||||||
| Loss before income tax expense | (9,131) | (17,325) | (28,172) | (46,216) | |||||||||
| Income tax expense | (389) | (150) | (610) | (316) | |||||||||
| Net loss attributable to common stockholders | $ | (9,520) | $ | (17,475) | $ | (28,782) | $ | (46,532) | |||||
| Weighted-average shares outstanding: | |||||||||||||
| Basic and diluted (in shares) | 46,137,833 | 39,621,738 | 46,257,397 | 36,978,528 | |||||||||
| Net loss per share—basic and diluted (in dollars per share) | $ | (0.21) | $ | (0.44) | $ | (0.62) | $ | (1.26) | |||||
| (1) Research and development reconciliation | |||||||||||||
| GAAP research and development | $ | 32,607 | $ | 30,835 | $ | 63,970 | $ | 58,198 | |||||
| Less: share-based compensation expense | 3,932 | 3,895 | 7,678 | 8,362 | |||||||||
| Non-GAAP research and development | $ | 28,675 | $ | 26,940 | $ | 56,292 | $ | 49,836 | |||||
| (2) Selling, general and administrative reconciliation | |||||||||||||
| GAAP selling, general and administrative | $ | 33,545 | $ | 28,866 | $ | 66,514 | $ | 54,365 | |||||
| Less: share-based compensation expense | 4,152 | 3,990 | 8,153 | 8,552 | |||||||||
| Non-GAAP selling, general and administrative | $ | 29,393 | $ | 24,876 | $ | 58,361 | $ | 45,813 |
| PTC Therapeutics, Inc Summary Consolidated Balance Sheets (In thousands, except per share data) | |||||||
| June 30, 2018 | December 31, 2017 | ||||||
| Cash, cash equivalents and marketable securities | $ | 296,106 | $ | 191,246 | |||
| Total assets | $ | 511,773 | $ | 391,653 | |||
| Total debt | $ | 148,870 | $ | 144,971 | |||
| Total deferred revenue | 10,540 | 11,891 | |||||
| Total liabilities | $ | 244,371 | $ | 235,216 | |||
| Total stockholders' equity (46,680,482 and 41,612,395 common shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively) | 267,402 | 156,437 | |||||
| Total liabilities and stockholders' equity | $ | 511,773 | $ | 391,653 |
| PTC Therapeutics, Inc Reconciliation of GAAP to Non-GAAP Projected Full Year 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 shared-based compensation expense | 30,000 | 30,000 | |||||
| Total projected non-GAAP R&D and SG&A expense | $ | 250,000 | $ | 260,000 |
SOURCE PTC Therapeutics, Inc.