$PTCT
PTC Therapeutics Inc

2024 Q3 Form 10-Q Financial Statement

#000107008124000017 Filed on August 08, 2024

View on sec.gov

Income Statement

Concept 2024 Q3 2024 Q2
Revenue $186.7M
YoY Change -12.68%
Cost Of Revenue $15.53M
YoY Change 21.96%
Gross Profit $171.2M
YoY Change -14.87%
Gross Profit Margin 91.68%
Selling, General & Admin $69.50M
YoY Change -21.42%
% of Gross Profit 40.6%
Research & Development $132.2M
YoY Change -28.89%
% of Gross Profit 77.21%
Depreciation & Amortization $7.018M
YoY Change -86.24%
% of Gross Profit 4.1%
Operating Expenses $226.9M
YoY Change 17.69%
Operating Profit -$40.22M
YoY Change -587.08%
Interest Expense -$43.49M
YoY Change 35.42%
% of Operating Profit
Other Income/Expense, Net -$2.025M
YoY Change -148.46%
Pretax Income -$85.73M
YoY Change -63.9%
Income Tax $13.45M
% Of Pretax Income
Net Earnings -$99.18M
YoY Change -50.13%
Net Earnings / Revenue -53.12%
Basic Earnings Per Share -$1.29
Diluted Earnings Per Share -$1.29
COMMON SHARES
Basic Shares Outstanding 76.92M 76.70M
Diluted Shares Outstanding 76.73M

Balance Sheet

Concept 2024 Q3 2024 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $1.093B
YoY Change 223.51%
Cash & Equivalents $654.8M
Short-Term Investments $438.5M
Other Short-Term Assets $45.64M
YoY Change 8.08%
Inventory $31.83M
Prepaid Expenses
Receivables $187.2M
Other Receivables $0.00
Total Short-Term Assets $1.358B
YoY Change 130.27%
LONG-TERM ASSETS
Property, Plant & Equipment $65.99M
YoY Change -63.1%
Goodwill $82.30M
YoY Change 0.0%
Intangibles $329.9M
YoY Change -26.96%
Long-Term Investments
YoY Change
Other Assets $23.10M
YoY Change -35.19%
Total Long-Term Assets $558.4M
YoY Change -25.38%
TOTAL ASSETS
Total Short-Term Assets $1.358B
Total Long-Term Assets $558.4M
Total Assets $1.916B
YoY Change 43.21%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $24.28M
YoY Change -75.15%
Accrued Expenses $86.66M
YoY Change -13.16%
Deferred Revenue
YoY Change
Short-Term Debt $0.00
YoY Change
Long-Term Debt Due $257.3M
YoY Change 139.16%
Total Short-Term Liabilities $609.8M
YoY Change 28.02%
LONG-TERM LIABILITIES
Long-Term Debt $284.8M
YoY Change -77.23%
Other Long-Term Liabilities $141.0K
YoY Change -99.9%
Total Long-Term Liabilities $284.9M
YoY Change -79.49%
TOTAL LIABILITIES
Total Short-Term Liabilities $609.8M
Total Long-Term Liabilities $284.9M
Total Liabilities $2.897B
YoY Change 51.07%
SHAREHOLDERS EQUITY
Retained Earnings -$3.474B
YoY Change 16.01%
Common Stock $76.00K
YoY Change 1.33%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$980.2M
YoY Change
Total Liabilities & Shareholders Equity $1.916B
YoY Change 43.21%

Cashflow Statement

Concept 2024 Q3 2024 Q2
OPERATING ACTIVITIES
Net Income -$99.18M
YoY Change -50.13%
Depreciation, Depletion And Amortization $7.018M
YoY Change -86.24%
Cash From Operating Activities -$71.45M
YoY Change 406.04%
INVESTING ACTIVITIES
Capital Expenditures -$7.375M
YoY Change -218.09%
Acquisitions
YoY Change
Other Investing Activities -$73.30M
YoY Change 318.68%
Cash From Investing Activities -$65.92M
YoY Change 177.55%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 246.5M
YoY Change 1235.22%
NET CHANGE
Cash From Operating Activities -71.45M
Cash From Investing Activities -65.92M
Cash From Financing Activities 246.5M
Net Change In Cash 109.1M
YoY Change -662.05%
FREE CASH FLOW
Cash From Operating Activities -$71.45M
Capital Expenditures -$7.375M
Free Cash Flow -$64.08M
YoY Change 214.65%

Facts In Submission

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">1.        The Company</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">PTC Therapeutics, Inc. (the “Company” or “PTC”) is a 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 innovate to identify new therapies and to globally commercialize products is the foundation that drives investment in a robust and diversified pipeline of transformative medicines. PTC’s mission is to provide access to best-in-class treatments for patients who have little to no treatment options. PTC’s strategy is to leverage its strong scientific and clinical expertise and global commercial infrastructure to bring therapies to patients.  PTC believes that this allows it to maximize value for all of its stakeholders. PTC has a diversified therapeutic portfolio pipeline that includes several commercial products and product candidates in various stages of development, including clinical, pre-clinical and research and discovery stages, focused on the development of new treatments for multiple therapeutic areas for rare diseases relating to neurology and metabolism.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company has two products, Translarna™ (ataluren) and Emflaza® (deflazacort), for the treatment of Duchenne muscular dystrophy (“DMD”), a rare, life threatening disorder. Translarna has marketing authorization in the European Economic Area (the “EEA”) for the treatment of nonsense mutation Duchenne muscular dystrophy (“nmDMD”) in ambulatory patients aged two years and older. Translarna also has marketing authorization in Russia for the treatment of nmDMD in patients aged two years and older and in Brazil for the treatment of nmDMD in ambulatory patients two years and older and for continued treatment of patients that become non-ambulatory, as well as in various other countries. Emflaza is approved in the United States for the treatment of DMD in patients two years and older. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">The Company’s marketing authorization for Translarna in the EEA is subject to annual review and renewal by the European Commission (“EC”) following reassessment by the European Medicines Agency (“EMA”) of the benefit-risk balance of the authorization, which the Company refers to as the annual EMA reassessment. In September 2022, the Company submitted a Type II variation to the EMA to support conversion of the conditional marketing authorization for Translarna to a standard marketing authorization, which included a report on the placebo-controlled trial of Study 041 and data from the open-label extension. In February 2023, the Company also submitted an annual marketing authorization renewal request to the EMA. In September 2023, the Committee for Medicinal Products for Human Use (“CHMP”), gave a negative opinion on the conversion of the conditional marketing authorization to full marketing authorization of Translarna for the treatment of nmDMD and a negative opinion on the renewal of the existing conditional marketing authorization of Translarna for the treatment of nmDMD. In January 2024, the CHMP issued a negative opinion for the renewal of the conditional marketing authorization following a re-examination procedure. In May 2024, the EC decided not to adopt the CHMP’s negative opinion for the renewal of the conditional marketing authorization of Translarna and returned such opinion to the CHMP for re-evaluation. On June 27, 2024, following the EC’s request for re-review, the CHMP issued a negative opinion on the renewal of the conditional marketing authorization of Translarna for the treatment of nmDMD. Per EMA guidelines, the Company has requested a re-examination of the CHMP’s negative opinion regarding the renewal of the existing conditional marketing authorization. The marketing authorization for Translarna remains in effect, pending the outcomes of the re-examination procedure and subsequent EC adoption. Based on the timeline of these procedures, the Company expects the marketing authorization for Translarna to remain in effect through the end of 2024 even if the CHMP’s negative opinion is maintained and adopted. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Translarna is an investigational new drug in the United States. Following the Company’s announcement of top-line results from the placebo-controlled trial of Study 041 in June 2022, the Company submitted a meeting request to the U.S. Food and Drug Administration (“FDA”) to gain clarity on the regulatory pathway for a potential re-submission of a New Drug Application (“NDA”) for Translarna. The FDA provided initial written feedback that Study 041 does not provide substantial evidence of effectiveness to support an NDA re-submission. The Company held a Type C meeting with the FDA in the fourth quarter of 2023 to discuss the totality of Translarna data. <span style="background:#ffffff;">Based on feedback from the FDA, the Company </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;"><span style="background:#ffffff;">re-submitted the NDA in July 2024, based on the results from Study 041 and from the Company’s international drug registry study for nmDMD patients receiving Translarna.</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company has developed Upstaza (eladocagene exuparvovec), a gene therapy used for the treatment of Aromatic L-Amino Acid Decarboxylase (“AADC”) deficiency (“AADC deficiency”), a rare central nervous system (“CNS”) disorder arising from reductions in the enzyme AADC that results from mutations in the dopa decarboxylase gene. In July 2022, the EC approved Upstaza for the treatment of AADC deficiency for patients 18 months and older within the EEA. In November 2022, the Medicines and Healthcare Products Regulatory Agency approved Upstaza for the treatment of AADC deficiency for patients 18 months and older within the United Kingdom. In March 2024, the Company submitted a biologics license application (“BLA”) for our gene therapy for the treatment of AADC deficiency in the United States. In May 2024, the FDA has accepted for filing the BLA and granted priority review with a target regulatory action date of November 13, 2024.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company holds the rights for the commercialization of Tegsedi<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">®</sup> (inotersen) and Waylivra<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">®</sup> (volanesorsen) for the treatment of rare diseases in countries in Latin America and the Caribbean pursuant to the Collaboration and License Agreement (the “Tegsedi-Waylivra Agreement”), dated August 1, 2018, by and between the Company and Akcea Therapeutics, Inc. (“Akcea”), a subsidiary of Ionis Pharmaceuticals, Inc. Tegsedi has received marketing authorization in the United States, the European Union (the “EU”) and Brazil for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (“hATTR amyloidosis”). In August 2021, ANVISA, the Brazilian health regulatory authority, approved Waylivra as the first treatment for familial chylomicronemia syndrome (“FCS”) in Brazil. In December 2022, ANVISA approved Waylivra for the treatment of familial partial lipodystrophy (“FPL”). Waylivra has also received marketing authorization in the EU for the treatment of FCS.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company also has a spinal muscular atrophy (“SMA”) collaboration with F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc. (referred to collectively as “Roche”) and the Spinal Muscular Atrophy Foundation (“SMA Foundation”). The SMA program has one approved product, Evrysdi® (risdiplam), which was approved by the FDA in August 2020 for the treatment of SMA in adults and children two months and older and by the EC in March 2021 for the treatment of 5q SMA in patients two months and older with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. Evrysdi has also received marketing authorization for the treatment of SMA in over 100 countries. In May <span style="letter-spacing:-0.1pt;">2022, the FDA approved a label expansion for Evrysdi to include infants under two months old with SMA. In August 2023, the EC approved an extension of the Evrysdi marketing authorization to include infants under two months old in the EU.</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">One of the Company’s most advanced clinical stage molecules is sepiapterin. Sepiapterin is a precursor to intracellular tetrahydrobiopterin, which is a critical enzymatic cofactor involved in metabolism and synthesis of numerous metabolic products. In May 2023, the Company announced that the primary endpoint was achieved in its registration-directed Phase 3 trial for sepiapterin for phenylketonuria (“PKU”). The primary endpoint of the study was the achievement of statistically-significant reduction in blood Phe level. In March 2024, the Company submitted a marketing authorization application (“MAA”) to the EMA for sepiapterin for the treatment of PKU in the EEA, which was validated and accepted for review by the EMA in May 2024. Additionally, the Company participated in a pre-NDA meeting with the FDA in the third quarter of 2023. At that meeting, the FDA stated that the sepiapterin clinical safety and efficacy data supported NDA submission for the treatment of pediatric and adult PKU patients. However, the FDA requested that PTC complete a 26-week nonclinical mouse study to assess sepiapterin carcinogenicity potential prior to NDA submission. In July 2024<span style="background:#ffffff;">, following completion of the in-life portion of the study, </span>the Company submitted an NDA to the FDA for sepiapterin for the treatment of PKU. PTC also expects to make regulatory submissions for sepiapterin for the treatment of PKU in Japan and Brazil later in 2024.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">In addition to the Company’s SMA program, the Company’s splicing platform also includes PTC518, which is being developed for the treatment of Huntington’s disease (“HD”). The Company initiated a Phase 2 study of PTC518 for the treatment of HD in the first quarter of 2022, which consists of an initial 12-week placebo-controlled phase focused on safety, pharmacology and pharmacodynamic effects followed by a nine-month placebo-controlled phase focused on PTC518 biomarker effect. In June 2023, the Company announced interim data from the 12-week placebo-controlled phase. In June 2024, the Company announced additional interim results from the Phase 2 study of PTC518. At month 12, PTC518 treatment demonstrated durable dose-dependent lowering of mutant HTT (“mHTT”) protein in the blood and dose-dependent lowering of mHTT protein in the cerebrospinal fluid in the interim cohort of stage 2 patients. In addition, </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">favorable trends were demonstrated on several relevant HD clinical assessments. Furthermore, following 12 months of treatment, PTC518 continued to be well tolerated. Based on its review of the interim Phase 2 study data, the FDA lifted the partial clinical hold on the program.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">The Company’s ferroptosis and inflammation platform consists of small molecule compounds that target oxidoreductase enzymes that regulate oxidative stress and inflammatory pathways central to the pathology of a number of CNS diseases. The two most advanced molecules in the Company’s ferroptosis and inflammation platform are vatiquinone and utreloxastat. The Company announced topline results from a registration-directed Phase 3 trial of vatiquinone in children and young adults with Friedreich ataxia, called MOVE-FA, in May 2023. While the study did not meet its primary endpoint, vatiquinone treatment did demonstrate significant benefit on key disease subscales, including the upright stability subscale, as well as on other disease relevant endpoints. In the first quarter of 2024, the Company met with the FDA, who expressed willingness to review an NDA for vatiquinone for the treatment of Friedreich ataxia based on the MOVE-FA trial as well as data from the ongoing open label extension study following the MOVE-FA trial. The Company plans to submit an NDA for vatiquinone in late 2024. The Company initiated a Phase 2 registration directed trial of utreloxastat for amyotrophic lateral sclerosis, or ALS, in the first quarter of 2022. The Company expects topline results from this trial in the fourth quarter of 2024.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">In addition, the Company has a pipeline of product candidates and discovery programs that are in early clinical, pre-clinical and research and development stages focused on the development of new treatments for multiple therapeutic areas for rare diseases.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">As of June 30, 2024, the Company had an accumulated deficit of approximately $3,474.3 million. The Company has financed its operations to date primarily through the private offerings of convertible senior notes (see Note 9), public and “at the market offerings” of common stock, proceeds from royalty purchase agreements (see Note 2), net proceeds from the Company’s borrowings under its credit agreement with Blackstone (see Note 9), private placements of its convertible preferred stock and common stock, collaborations, bank and institutional lender debt, other convertible debt, grant funding and clinical trial support from governmental and philanthropic organizations and patient advocacy groups in the disease area addressed by the Company’s product candidates. The Company has also relied on revenue generated from net sales of Translarna for the treatment of nmDMD in territories outside of the United States since 2014, Emflaza for the treatment of DMD in the United States since 2017, and Upstaza for the treatment of AADC deficiency in the EEA since May 2022. The Company has also relied on revenue associated with milestone and royalty payments from Roche pursuant to the License and Collaboration Agreement (the “SMA License Agreement”) dated as of November 23, 2011, by and among the Company, Roche and, for the limited purposes set forth therein, the SMA Foundation, under its SMA program. The Company expects that cash flows from the sales of its products, milestone and royalty payments from Roche, together with the Company’s cash, cash equivalents and marketable securities, will be sufficient to fund its operations for at least the next twelve months. </p>
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CY2024Q2 us-gaap Finite Lived Intangible Assets Amortization Expense Remainder Of Fiscal Year
FiniteLivedIntangibleAssetsAmortizationExpenseRemainderOfFiscalYear
5719000
CY2024Q2 us-gaap Finite Lived Intangible Assets Amortization Expense Next Twelve Months
FiniteLivedIntangibleAssetsAmortizationExpenseNextTwelveMonths
11429000
CY2024Q2 us-gaap Finite Lived Intangible Assets Amortization Expense Year Two
FiniteLivedIntangibleAssetsAmortizationExpenseYearTwo
11429000
CY2024Q2 us-gaap Finite Lived Intangible Assets Amortization Expense Year Three
FiniteLivedIntangibleAssetsAmortizationExpenseYearThree
11429000
CY2024Q2 ptct Finite Lived Intangible Assets Amortization Expense Year Four And Thereafter
FiniteLivedIntangibleAssetsAmortizationExpenseYearFourAndThereafter
54107000
CY2024Q2 us-gaap Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
94113000
CY2024Q2 us-gaap Indefinite Lived Intangible Assets Excluding Goodwill
IndefiniteLivedIntangibleAssetsExcludingGoodwill
329879000
us-gaap Indefinite Lived Intangible Assets Period Increase Decrease
IndefiniteLivedIntangibleAssetsPeriodIncreaseDecrease
0
us-gaap Goodwill Period Increase Decrease
GoodwillPeriodIncreaseDecrease
0
CY2024Q2 us-gaap Goodwill
Goodwill
82300000
CY2024Q2 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
CY2024Q2 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false
CY2024Q2 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false

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0001070081-24-000017.txt Edgar Link pending
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tmb-20240630_lab.xml Edgar Link unprocessable
tmb-20240630_pre.xml Edgar Link unprocessable
tmb-20240630x10q_htm.xml Edgar Link completed
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