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SOUTH PLAINFIELD, N.J., Oct. 27, 2022 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and financial results for the third quarter ending September 30, 2022.
"Our mission is to build an enduring biopharmaceutical company that treats diseases with significant unmet medical needs," said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. "We continue to achieve our ambitious goals for 2022 of generating strong revenue growth while advancing our broad and deep pipeline to continue to fulfill this vision."
Key Corporate Updates:
Key Clinical and Regulatory Updates:
Third Quarter 2022 Financial Highlights:
PTC Updates Full Year 2022 Financial Guidance as Follows:
Non-GAAP Financial Measures:
In this press release, the financial results of PTC are provided in accordance with 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 September 30, | Nine Months Ended September 30, | ||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||
Revenues: | |||||||||||
Net product revenue | $ | 134,186 | $ | 115,605 | $ | 407,720 | $ | 309,998 | |||
Collaboration revenue | 50,017 | 10,011 | 50,024 | 30,018 | |||||||
Royalty revenue | 32,924 | 13,127 | 73,645 | 33,348 | |||||||
Total revenues | 217,127 | 138,743 | 531,389 | 373,364 | |||||||
Operating expenses: | |||||||||||
Cost of product sales | 14,011 | 6,539 | 33,785 | 23,001 | |||||||
Amortization of acquired intangible asset, | 31,023 | 14,383 | 80,790 | 38,411 | |||||||
Research and development (1) | 165,462 | 130,845 | 462,802 | 390,840 | |||||||
Selling, general and administrative (2) | 80,118 | 69,252 | 233,280 | 199,225 | |||||||
Change in the fair value of deferred and | (5,300) | 10,800 | (32,200) | 11,600 | |||||||
Total operating expenses | 285,314 | 231,819 | 778,457 | 663,077 | |||||||
Loss from operations | (68,187) | (93,076) | (247,068) | (289,713) | |||||||
Interest expense, net | (20,880) | (21,802) | (66,371) | (63,520) | |||||||
Other expense, net | (38,141) | (18,782) | (84,355) | (26,499) | |||||||
Loss before income tax expense | (127,208) | (133,660) | (397,794) | (379,732) | |||||||
Income tax benefit (expense) | 17,893 | 36 | 9,666 | (904) | |||||||
Net loss attributable to common stockholders | $ | (109,315) | $ | (133,624) | $ | (388,128) | $ | (380,636) | |||
Weighted-average shares outstanding: | |||||||||||
Basic and diluted (in shares) | 71,654,671 | 70,585,938 | 71,415,849 | 70,397,846 | |||||||
Net loss per share—basic and diluted (in dollars per share) | $ | (1.53) | $ | (1.89) | $ | (5.43) | $ | (5.41) | |||
(1) Research and development reconciliation | |||||||||||
GAAP research and development | $ | 165,462 | $ | 130,845 | $ | 462,802 | $ | 390,840 | |||
Less: share-based compensation expense | 15,063 | 13,048 | 41,896 | 40,216 | |||||||
Non-GAAP research and development | $ | 150,399 | $ | 117,797 | $ | 420,906 | $ | 350,624 | |||
(2) Selling, general and administrative reconciliation | |||||||||||
GAAP selling, general and administrative | $ | 80,118 | $ | 69,252 | $ | 233,280 | $ | 199,225 | |||
Less: share-based compensation expense | 13,607 | 12,823 | 41,093 | 37,061 | |||||||
Non-GAAP selling, general and administrative | $ | 66,511 | $ | 56,429 | $ | 192,187 | $ | 162,164 | |||
PTC Therapeutics, Inc. | |||||
Summary Consolidated Balance Sheets | |||||
(in thousands, except share data) | |||||
September 30, | December 31, | ||||
Cash, cash equivalents and marketable securities | $ | 288,432 | $ | 773,376 | |
Total Assets | $ | 1,576,398 | $ | 1,938,056 | |
Total debt | $ | 282,749 | $ | 431,434 | |
Total liability for sale of future royalties | 758,146 | 733,985 | |||
Total liabilities | $ | 1,803,302 | $ | 1,936,618 | |
Total stockholders' (deficit) equity (71,854,892 and 70,828,226 | $ | (226,904) | $ | 1,438 | |
Total liabilities and stockholders' (deficit) equity | $ | 1,576,398 | $ | 1,938,056 |
PTC Therapeutics, Inc. | |||||
Reconciliation of GAAP to Non-GAAP Projected Full Year 2022 R&D and SG&A Expense | |||||
(In thousands) | |||||
Low End of Range | High End of Range | ||||
Projected GAAP R&D and SG&A Expense | $ | 925,000 | $ | 965,000 | |
Less: projected non-cash, stock-based compensation expense | 115,000 | 115,000 | |||
Projected non-GAAP R&D and SG&A expense | $ | 810,000 | $ | 850,000 |
Acronyms:
AADC: Aromatic L-amino acid decarboxylase
ALS: Amyotrophic Lateral Sclerosis
DMD: Duchenne Muscular Dystrophy
FDA: U.S. Food and Drug Administration
PKU: Phenylketonuria
R&D: Research and Development
SG&A: Selling, General and Administrative
SMA: Spinal Muscular Atrophy
Today's Conference Call and Webcast Reminder:
To access the call by phone, please click here to register and you will be provided with dial-in details. To avoid delays, we recommend participants dial in to the conference call 15 minutes prior to the start of the call. The webcast conference call can be accessed on the Investor section of the PTC website at https://ir.ptcbio.com/events-presentations. A 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. The company's strategy is to leverage its strong scientific expertise and global commercial infrastructure to maximize value for its patients and other stakeholders. To learn more about PTC, please visit us at www.ptcbio.com and follow us on Facebook, on Twitter at @PTCBio, and on LinkedIn.
For More Information:
Investors:
Kylie O'Keefe
+1 (908) 300-0691
kokeefe@ptcbio.com
Media:
Jeanine Clemente
+1 (908) 912-9406
jclemente@ptcbio.com
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 "PTC Updates Full Year 2022 Financial Guidance as Follows", including with respect to (i) 2022 total revenue guidance, (ii) 2022 net product revenue guidance for the DMD franchise and (iii) 2022 GAAP and non-GAAP R&D and SG&A expense guidance, and statements regarding: the future expectations, plans and prospects for PTC, including with respect to the expected timing of clinical trials and studies, availability of data, regulatory submissions and responses and other matters; expectations with respect to Upstaza and other programs within PTC's gene therapy platform, including any regulatory submissions, commercialization and manufacturing capabilities; advancement of PTC's joint collaboration program in SMA, including any 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: expectations with respect to the COVID-19 pandemic and related response measures and their effects on PTC's business, operations, clinical trials, regulatory submissions and approvals, and PTC's collaborators, contract research organizations, suppliers and manufacturers; 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 Upstaza and other programs within PTC's gene therapy platform, including any regulatory submissions and potential approvals, commercialization, 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; expectations with respect to the commercialization of Evrysdi under our SMA collaboration; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in Brazil, Russia, the European Economic Area (EEA) and other regions, 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 complete Study 041, which is a specific obligation to continued marketing authorization in the EEA; PTC's ability to utilize results from 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, to support a marketing approval for Translarna for the treatment of nmDMD in the United States and a conversion to a standard marketing authorization in the EEA; expectations with respect to the commercialization of Tegsedi and Waylivra; the results of PTC's clinical trial for emvododstat for COVID-19; 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 its lease agreements, including for its leased biologics manufacturing facility; PTC's ability to satisfy its obligations under the terms of the secured credit facility with Blackstone; 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, Emflaza, Upstaza, Evrysdi, 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.
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SOURCE PTC Therapeutics, Inc.