PTC Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Rhea-AI Summary
PTC Therapeutics reported Q3 2024 total revenue of $196.8 million, leading to increased full-year guidance of $750-800 million. The DMD franchise generated $124 million, with Translarna contributing $72.3 million and Emflaza $51.9 million. The company has three FDA applications under review and plans a fourth submission for vatiquinone in December. Q3 net loss was $106.7 million, improved from $133.0 million in Q3 2023. Cash position strengthened to $1.01 billion as of September 30, 2024, up from $876.7 million at end of 2023.
Positive
- Increased full-year revenue guidance to $750-800 million
- Strong cash position of $1.01 billion, up from $876.7 million in December 2023
- Royalty revenue increased to $61.4 million from $50.2 million year-over-year
- Reduced net loss to $106.7 million from $133.0 million year-over-year
- Decreased SG&A expenses to $73.5 million from $80.9 million year-over-year
Negative
- Total product revenue declined to $135.4 million from $144.0 million year-over-year
- Emflaza revenue decreased to $51.9 million from $67.4 million year-over-year
- Operating loss of $54.5 million in Q3 2024
- Increased interest expense to $41.6 million from $28.2 million year-over-year
News Market Reaction
On the day this news was published, PTCT gained 3.07%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
– Strong revenue performance, supporting increase in full-year revenue guidance to
– Regulatory filings for sepiapterin, Translarna™ and AADC gene therapy under review by FDA –
– On track to achieve remaining 2024 clinical and regulatory milestones, including NDA submission for vatiquinone –
WARREN, N.J., Nov. 7, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced a corporate update and financial results for the third quarter ending September 30, 2024.
"I am proud of our team's strong execution," said Matthew Klein, M.D., Chief Executive Officer. "We continue to achieve excellent revenue performance allowing us to raise full-year revenue guidance. In addition, we have submitted three approval applications to FDA so far this year, all of which have been accepted for review, and plan a fourth submission for vatiquinone for Friedreich ataxia in December. We are on our way to accomplishing all of our 2024 objectives and are in a strong financial position to execute on our long-term strategic plans."
Key Corporate Updates:
- Third quarter 2024 total revenue of
$197 million - Third quarter 2024 revenue for the DMD franchise was
$124 million - Translarna™ (ataluren) net product revenue was
$72 million - Emflaza® (deflazacort) net product revenue was
$52 million
- Translarna™ (ataluren) net product revenue was
Key Clinical and Regulatory Milestones:
- PTC submitted an NDA to the FDA for sepiapterin for the treatment of PKU. The file was accepted for review, and the regulatory action date is set for July 29, 2025.
- PTC resubmitted the NDA for Translarna for the treatment of nmDMD; the file was accepted, and a regulatory action date was not provided.
- The BLA for PTC's gene therapy for AADC deficiency remains on schedule for a regulatory action date of November 13, 2024.
- PTC received Fast Track Designation for the PTC518 Huntington's disease program.
- PTC plans to submit an NDA for vatiquinone for the treatment of Friedreich ataxia in December 2024.
- PTC expects to share topline data for the CardinALS trial of utreloxastat for the treatment of ALS in the fourth quarter of 2024.
Third Quarter 2024 Financial Highlights:
- Total revenues were
$196.8 million $196.6 million - Total revenue includes net product revenue across the commercial portfolio of
$135.4 million $144.0 million $61.4 million $52.5 million - Translarna net product revenues were
$72.3 million $69.0 million - Emflaza net product revenues were
$51.9 million $67.4 million - Roche reported Evrysdi® 2024 year-to-date sales of approximately
CHF 1.2 billion , resulting in royalty revenue of$61.4 million $50.2 million - Based on
U.S. GAAP (Generally Accepted Accounting Principles), GAAP R&D expenses were$161.4 million $164.2 million $50.0 million - Non-GAAP R&D expenses were
$152.0 million $9.4 million $150.2 million $14.0 million - GAAP SG&A expenses were
$73.5 million $80.9 million - Non-GAAP SG&A expenses were
$63.1 million $10.3 million $67.9 million $13.0 million - Change in the fair value of deferred and contingent consideration was a loss of
$0.7 million $1.5 million - Tangible asset impairment and losses (gains) on transactions, net, was a loss of
$1.8 million $0.0 million - Net loss was
$106.7 million $133.0 million - Cash, cash equivalents, and marketable securities was
$1,013.4 million $876.7 million - Shares issued and outstanding as of September 30, 2024, were 76,952,124.
PTC Updates Full Year 2024 Financial Guidance:
- PTC anticipates total revenues for full year 2024 to be between
$750 million $800 million - PTC anticipates GAAP R&D and SG&A expenses for full year 2024 to be between
$740 million $835 million $65 million - PTC anticipates non-GAAP R&D and SG&A expenses for full year 2024 to be between
$660 million $755 million $65 million $80 million - PTC anticipates up to
$90 million $65 million $85 million $65 million $20 million
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 R&D and SG&A expense 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. | |||||||||||
Three Months Ended | Nine Months Ended September | ||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||
Revenues: | |||||||||||
Net product revenue | $ | 135,421 | $ | 144,038 | $ | 446,245 | $ | 506,187 | |||
Collaboration revenue | - | - | - | 6 | |||||||
Royalty revenue | 61,365 | 50,173 | 145,702 | 117,857 | |||||||
Manufacturing revenue | - | 2,365 | 1,661 | 6,716 | |||||||
Total revenues | 196,786 | 196,576 | 593,608 | 630,766 | |||||||
Operating expenses: | |||||||||||
Cost of product sales, excluding amortization of acquired | 10,848 | 9,493 | 41,115 | 36,368 | |||||||
Amortization of acquired intangible asset | 3,036 | 58,649 | 57,431 | 145,461 | |||||||
Research and development (1) | 161,412 | 164,212 | 409,710 | 545,210 | |||||||
Selling, general and administrative (2) | 73,456 | 80,886 | 216,228 | 256,249 | |||||||
Change in the fair value of deferred and contingent | 700 | 1,500 | 5,700 | (125,000) | |||||||
Intangible asset impairment | - | - | - | 217,800 | |||||||
Tangible asset impairment and losses (gains) on transactions, | 1,844 | - | 3,605 | - | |||||||
Total operating expenses | 251,296 | 314,740 | 733,789 | 1,076,088 | |||||||
Loss from operations | (54,510) | (118,164) | (140,181) | (445,322) | |||||||
Interest expense, net | (41,609) | (28,160) | (125,933) | (84,905) | |||||||
Other expense, net | (1,872) | (20,266) | (2,306) | (8,832) | |||||||
Loss before income tax (expense) benefit | (97,991) | (166,590) | (268,420) | (539,059) | |||||||
Income tax (expense) benefit | (8,663) | 33,620 | (28,989) | 68,247 | |||||||
Net loss attributable to common stockholders | $ | (106,654) | $ | (132,970) | $ | (297,409) | $ | (470,812) | |||
Weighted-average shares outstanding: | |||||||||||
Basic and diluted (in shares) | 76,925,523 | 75,377,997 | 76,716,340 | 74,618,611 | |||||||
Net loss per share—basic and diluted (in dollars per share) | $ | (1.39) | $ | (1.76) | $ | (3.88) | $ | (6.31) | |||
(1) Research and development reconciliation | |||||||||||
GAAP research and development | $ | 161,412 | $ | 164,212 | $ | 409,710 | $ | 545,210 | |||
Less: share-based compensation expense | 9,416 | 13,986 | 27,810 | 44,828 | |||||||
Non-GAAP research and development | $ | 151,996 | $ | 150,226 | $ | 381,900 | $ | 500,382 | |||
(2) Selling, general and administrative reconciliation | |||||||||||
GAAP selling, general and administrative | $ | 73,456 | $ | 80,886 | $ | 216,228 | $ | 256,249 | |||
Less: share-based compensation expense | 10,339 | 12,956 | 29,566 | 40,300 | |||||||
Non-GAAP selling, general and administrative | $ | 63,117 | $ | 67,930 | $ | 186,662 | $ | 215,949 | |||
PTC Therapeutics, Inc. | |||||
September 30, 2024 | December 31, 2023 | ||||
Cash, cash equivalents and marketable securities | $ | 1,013,357 | $ | 876,739 | |
Total assets | $ | 1,842,236 | $ | 1,895,698 | |
Total debt | $ | 285,106 | $ | 284,213 | |
Total deferred revenue | - | 801 | |||
Total liability for sale of future royalties | 2,082,051 | 1,814,097 | |||
Total liabilities | $ | 2,896,588 | $ | 2,714,253 | |
Total stockholders' deficit (76,952,124 and 75,708,889 | $ | (1,054,352) | $ | (818,555) | |
Total liabilities and stockholders' deficit | $ | 1,842,236 | $ | 1,895,698 | |
PTC Therapeutics, Inc. | ||
Full Year 2024 | ||
(in millions) | ||
Projected GAAP R&D Expense Related Milestone Payments | $ | 65 |
Projected GAAP Contingent Consideration Payable Related Milestone Payments | 25 | |
Total Projected GAAP Milestone Payments | $ | 90 |
PTC Therapeutics, Inc. | ||||||
Low End | High End | |||||
Projected GAAP R&D and SG&A Expense | $ | 740 | $ | 835 | ||
Less: projected non-cash, stock-based compensation expense | 80 | 80 | ||||
Projected non-GAAP R&D and SG&A expense | $ | 660 | $ | 755 | ||
Acronyms:
AADC: Aromatic l-Amino Acid Decarboxylase
ALS: Amyotrophic Lateral Sclerosis
BLA: Biologics License Application
CHF: Confoederatio Helvetica Francs (Swiss francs)
DMD: Duchenne Muscular Dystrophy
FA: Friedreich Ataxia
FDA:
GAAP: Generally Accepted Accounting Principles
HD: Huntington's Disease
NDA: New Drug Application
nmDMD: Nonsense Mutation Duchenne Muscular Dystrophy
PKU: Phenylketonuria
R&D: Research and Development
SG&A: Selling, General, and Administrative
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 global biopharmaceutical company focused on the discovery, development and commercialization of clinically differentiated medicines that provide benefits to children and adults living 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, X, and LinkedIn.
For More Information:
Investors:
Ellen Cavaleri
+1 (615) 618-6228
ecavaleri@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 2024 Financial Guidance", including with respect to (i) 2024 total revenue guidance, (ii) 2024 GAAP and non-GAAP R&D and SG&A expense guidance and (iii) 2024 acquisition related milestone payment 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, commercialization and other matters with respect to its products and product candidates; PTC's strategy, future operations, future financial position, future revenues, projected costs; the extent, timing and financial aspects of our strategic pipeline prioritization and reductions in workforce; 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; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in
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, Waylivra or sepiapterin.
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:https://www.prnewswire.com/news-releases/ptc-therapeutics-provides-corporate-update-and-reports-third-quarter-2024-financial-results-302299330.html
SOURCE PTC Therapeutics, Inc.
FAQ
What was PTC Therapeutics (PTCT) revenue in Q3 2024?
What is PTC Therapeutics' (PTCT) full-year 2024 revenue guidance?
How much cash does PTC Therapeutics (PTCT) have as of Q3 2024?
What was PTC Therapeutics' (PTCT) net loss in Q3 2024?
