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PTC Therapeutics Reports Second Quarter 2020 Financial Results and Provides a Corporate Update


SOUTH PLAINFIELD, N.J., Aug. 5, 2020 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the second quarter ending June 30, 2020.

"We are pleased with the progress in our pipeline and the strong commercial performance of our global Duchenne franchise," said Stuart W. Peltz, Ph.D., CEO of PTC Therapeutics. "Our growing revenue stream allows us to continue to invest in the development of treatments leveraging our novel technology platforms. We have a robust pipeline and with more than $1 billion in cash are well positioned to advance multiple differentiated therapies for patients living with rare disorders, not only in the near term, but also for many years to come."

Key Second Quarter and Other Corporate Updates:

Updates in PTC's Diverse Product Pipeline

Financial Highlights:

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 June 30,


Six Months Ended June 30,



2020


2019


2020


2019

Revenues:








Net product revenue


$

75,239



$

85,476



$

143,435


$

138,530


Collaboration and grant revenue


?



46



63


575


Total revenues


75,239



85,522



143,498


139,105


Operating expenses:








Cost of product sales


5,304



3,211



9,389


5,587


Amortization of acquired intangible asset


8,731



6,575



16,679


12,652


Research and development (1)


176,525



59,979



266,632


112,544


Selling, general and administrative (2)


53,659



49,215



111,869


89,760


Change in the fair value of deferred and contingent consideration


7,680



5,300



8,580


26,460


Settlement of deferred and contingent consideration


10,613



?



10,613


?


Total operating expenses


262,512



124,280



423,762


247,003


Loss from operations


(187,273)



(38,758)



(280,264)


(107,898)


Interest expense, net


(5,379)



(2,074)



(11,021)


(4,362)


Other income (expense), net


11,309



(183)



(2,523)


(292)


Loss before income tax expense


(181,343)



(41,015)



(293,808)


(112,552)


Income tax expense


(84)



(774)



(306)


(1,350)


Net loss attributable to common stockholders


$

(181,427)



$

(41,789)



$

(294,114)


$

(113,902)










Weighted-average shares outstanding:








Basic and diluted (in shares)


65,150,780



55,912,748



63,769,958


57,113,141


Net loss per share?basic and diluted (in dollars per share)


$

(2.78)



$

(0.75)



$

(4.61)


$

(1.99)










(1) Research and development reconciliation








GAAP research and development


$

176,525



$

59,979



$

266,632


$

112,544


Less: share-based compensation expense


8,562



5,516



16,741


10,203


Non-GAAP research and development


$

167,963



$

54,463



$

249,891


$

102,341










(2) Selling, general and administrative reconciliation








GAAP selling, general and administrative


$

53,659



$

49,215



$

111,869


$

89,760


Less: share-based compensation expense


8,348



5,404



15,389


9,981


Non-GAAP selling, general and administrative


$

45,311



$

43,811



$

96,480


$

79,779










 

PTC Therapeutics, Inc.
Summary Consolidated Balance Sheets
(in thousands, except share data)




June 30, 2020


December 31, 2019

Cash, cash equivalents and marketable securities


$

498,891



$

686,563


Total Assets


$

1,476,637



$

1,623,782







Total debt


$

315,362



$

313,859


Total deferred revenue


7,702



11,657


Total liabilities


$

904,143



$

1,029,452







Total stockholders' equity (67,240,679 and 61,935,870 common shares issued and outstanding at June 30, 2020 and December 31, 2019 respectively)


$

572,494



$

594,330


Total liabilities and stockholders' equity


$

1,476,637



$

1,623,782







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 5897698. 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. 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. 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:
Alex Kane
+1 (908) 912-9643
[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 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 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 expected use of proceeds from the agreement with Royalty Pharma; PTC's expectations with respect to the licensing, regulatory submissions and commercialization of its products and product candidates; the timing with respect to orders for PTC's products; expectations with respect to the impacts of the COVID-19 pandemic and related response measures; 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 ongoing 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 respect 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; the enrollment, conduct and results of PTC's PTC299 clinical trial for COVID-19; expectations with respect to the COVID-19 pandemic and related response measures and their effects on PTC's business, operations, clinical trials, potential regulatory submissions and approvals, and PTC's collaborators, contract research organizations, suppliers and manufacturers; 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; 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, risdiplam, Tegsedi, Waylivra or PTC-AADC.

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.

SOURCE PTC Therapeutics, Inc.


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