Form 8-K

8-K — PTC THERAPEUTICS, INC.

Accession: 0001104659-26-120200

Filed: 2026-10-29

Period: 2026-10-29

CIK: 0001070081

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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8-K

8-K (Primary)

Filename: tmb-20261029x8k.htm · Sequence: 1

PTC THERAPEUTICS, INC._October 29, 2026

0001070081false00010700812026-10-292026-10-29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 29, 2026

PTC THERAPEUTICS, INC.

(Exact Name of Company as Specified in Charter)

Delaware

001-35969

04-3416587

(State or Other Jurisdiction

(Commission

(IRS Employer

of Incorporation)

File Number)

Identification No.)

500 Warren Corporate Center Drive

Warren, NJ

07059

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (908) 222-7000

Not applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value per share

PTCT

Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On October 29, 2026, PTC Therapeutics, Inc. (the “Company”) announced its financial results for the quarter ended September 30, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) and is incorporated by reference into this Item 2.02.

Item 7.01. Regulation FD Disclosure.

The Company will host a conference call on October 29, 2026 at 4:30 p.m. eastern time, as previously announced. During this call the Company expects to review financial results for the quarter ended September 30, 2026, as well as other corporate highlights and updates. Instructions on how to access the conference call are included in the press release furnished as Exhibit 99.1 hereto.

The Company has also updated its corporate presentation as of October 29, 2026. The Company’s corporate presentation will be posted in the Events and Presentations page under the Investors section of the Company’s website. A copy of the corporate presentation is also attached to this Report as Exhibit 99.2 and is incorporated by reference into this Item 7.01.

The information in this Report (including Items 2.02 and 7.01 and Exhibits 99.1 and 99.2) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. All website addresses given in this Report or incorporated herein by reference are for information only and are not intended to be an active link or to incorporate any website information into this Report.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release, dated October 29, 2026 issued by PTC Therapeutics, Inc.

99.2

Corporate Presentation – October 2026

104

The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

Signature

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned hereunto duly authorized.

PTC Therapeutics, Inc.

Date: October 29, 2026

By:

/s/ Pierre Gravier

Name:

Pierre Gravier

Title:

Chief Financial Officer

EX-99.1

Filename: tmb-ex99d1.htm · Sequence: 2

Exhibit 99.1

PTC Therapeutics Provides Corporate Update

and Reports Third Quarter 2026 Financial Results

– Strong Q3 2026 performance with total revenue of $358 million, including $276 million of product revenue –

– Full-year 2026 expected total revenue increased to $1.29 to $1.32 billion, with full-year product revenue guidance raised to $960 to $990 million –

– Sephience™ (sepiapterin) Q3 2026 revenue of $182 million, with continued growth in the US and ongoing global expansion –

– Acquired ST-920 Fabry disease gene therapy; BLA submission expected to be completed in Q4 2026 –

WARREN, N.J., October 29, 2026 – PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced a corporate update and financial results for the third quarter ended September 30, 2026.

"We delivered another strong quarter of record product revenue led by the continued momentum of the Sephience launch, putting us firmly on track to achieve our cash flow breakeven milestone this year," said Matthew B. Klein, M.D., Chief Executive Officer. "Now at the one-year mark, the launch has been a success by all measures. With a strong patient base, the large global market, and the reports of meaningful treatment benefits, we look forward to continued growth both in the US and internationally.”

Key Corporate Updates

Q3 2026 total revenue of $358 million, including $276 million of product revenue

Sephience launch momentum continues with steady growth in the US and ongoing global expansion

Q3 2026 revenue of $182 million, including $145 million revenue in the US and $37 million revenue ex-US, up over 20% from Q2 2026

Over 2,000 active patients worldwide as of September 30, 2026

ST-920 Fabry disease BLA submission expected to be completed in Q4 2026

ST-920 is a one-time administered AAV gene therapy with the potential to reduce the burden associated with chronic enzyme replacement therapy

Potential FDA accelerated approval and commercial launch in 2027

Votoplam Huntington’s disease program continues to advance

Due to FDA scheduling, Type C meeting to discuss votoplam Phase 2 data and potential accelerated approval path now scheduled for Q1 2027

Global Phase 3 INVEST-HD study actively enrolling at sites worldwide with target enrollment of approximately 770 early symptomatic patients

Vatiquinone PROVE-FA study to support NDA resubmission for treatment of Friedreich’s ataxia initiated in Q3 2026

Global study will enroll approximately 120 patients ages 7 to 21

Study includes open-label treatment arm with matched natural history control arm

PTC pipeline advances across multiple programs

Initiated Phase 2a study of PTC844, a next-generation DHODH inhibitor

Ongoing Phase 1 study of PTC612, an oral NLRP3 inhibitor, continues to advance

PTC303, a splicing development candidate targeting MSH3, expected to enter clinic in 2027

Third Quarter 2026 Financial Highlights

Total net product revenue and royalty revenue was $357.6 million for the third quarter of 2026, compared to $201.7 million for the third quarter of 2025.

Total net product revenue across the commercial portfolio was $275.9 million for the third quarter of 2026, compared to $131.0 million for the third quarter of 2025, representing an over 100% increase.

Sephience net product revenues were $181.9 million for the third quarter of 2026, representing 20% growth compared to the second quarter of 2026.

Translarna™ (ataluren) net product revenues were $48.5 million for the third quarter of 2026, compared to $50.7 million for the third quarter of 2025. Translarna third quarter 2026 revenue includes a government purchase order from Russia.

Emflaza® (deflazacort) net product revenues were $25.1 million for the third quarter of 2026, compared to $35.2 million for the third quarter of 2025.

Roche reported Evrysdi® (risdiplam) year-to-date sales of approximately CHF 1,470 million, resulting in royalty revenue of $81.7 million to PTC for the third quarter of 2026, compared to $70.8 million to PTC for the third quarter of 2025.

Based on US GAAP (Generally Accepted Accounting Principles), GAAP R&D expenses were $105.4 million for the third quarter of 2026, compared to $100.2 million for the third quarter of 2025.

Non-GAAP R&D expenses were $94.9 million for the third quarter of 2026, excluding $10.5 million in non-cash, stock-based compensation expense, compared to $91.0 million for the third quarter of 2025, excluding $9.1 million in non-cash, stock-based compensation expense.

GAAP SG&A expenses were $80.1 million for the third quarter of 2026, compared to $84.0 million for the third quarter of 2025.

Non-GAAP SG&A expenses were $66.7 million for the third quarter of 2026, excluding $13.3 million in non-cash, stock-based compensation expense, compared to $73.8 million for the third quarter of 2025, excluding $10.3 million in non-cash, stock-based compensation expense.

Net loss was $51.7 million for the third quarter of 2026, compared to net income of $15.9 million for the third quarter of 2025.

In Q3 2026, the Company acquired the ST-920 gene therapy for Fabry disease for $111.0 million upfront, with up to an additional $100.0 million in contingent milestone payments based on US regulatory approvals. Acquired in-process research and development expense was $111.0 million for the third quarter of 2026 and related to the purchase of the ST-920 program.

Cash, cash equivalents, and marketable securities were $2,127.9 million on September 30, 2026, compared to $1,945.4 million on December 31, 2025.

Shares issued and outstanding as of September 30, 2026, were 83,535,767.

PTC Updates Full-Year 2026 Financial Guidance

Expected total revenue increased to $1.29 to $1.32 billion, with total product revenue guidance raised to $960 to $990 million from $850 to $950 million

GAAP R&D and SG&A expense guidance remains $775 to $815 million

Non-GAAP R&D and SG&A expense guidance remains $680 to $720 million, excluding estimated non-cash, stock-based compensation expense of $95 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 accordance with 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,

2026

2025

2026

2025

Revenues:

Net product revenue

275,894

130,956

740,286

402,711

Collaboration and license revenue

229

9,258

50,967

998,430

Royalty revenue

81,684

70,793

199,624

164,837

Total revenues

357,807

211,007

990,877

1,565,978

Operating expenses:

Cost of product, collaboration and license sales, excluding amortization of acquired intangible assets

23,664

15,781

71,613

40,063

Amortization of acquired intangible assets

12,595

7,534

36,017

15,393

Research and development (1)

105,353

100,158

305,376

322,121

Selling, general and administrative (2)

80,081

84,046

246,894

250,269

Change in the fair value of contingent consideration

—

(800)

Tangible asset impairment and losses on transactions, net

—

472

927

648

Acquired in-process research and development *

111,000

—

111,000

—

Total operating expenses

332,693

207,991

771,827

627,694

Income from operations

25,114

3,016

219,050

938,284

Interest expense, net

(45,866)

(32,592)

(143,377)

(97,042)

Other (expense) income, net

(1,073)

6,502

(2,415)

(5,540)

Loss on extinguishment of debt

(19,263)

—

(19,263)

—

(Loss) income before income tax (expense) benefit

(41,088)

(23,074)

53,995

835,702

Income tax (expense) benefit

(10,605)

38,970

(25,001)

(18,093)

Net (loss) income attributable to common stockholders

(51,693)

15,896

28,994

817,609

Weighted-average shares outstanding:

Basic (in shares)

83,476,100

78,471,119

83,004,625

78,642,478

Diluted (in shares)

83,476,100

87,115,369

92,253,675

86,899,727

Net (loss) income per share—basic (in dollars per share)

(0.62)

0.20

0.35

10.40

Net (loss) income per share—diluted (in dollars per share)

(0.62)

0.20

0.34

9.45

(1) Research and development reconciliation

GAAP research and development

105,353

100,158

305,376

322,121

Less: share-based compensation expense

10,479

9,133

32,155

26,827

Non-GAAP research and development

94,874

91,025

273,221

295,294

(2) Selling, general and administrative reconciliation

GAAP selling, general and administrative

80,081

84,046

246,894

250,269

Less: share-based compensation expense

13,348

10,293

38,384

29,202

Non-GAAP selling, general and administrative

66,733

73,753

208,510

221,067

* In Q3 2026, the Company purchased the ST-920 asset from Sangamo Therapeutics, Inc. and paid an upfront cash consideration of $111.0 million which was recorded as Acquired in-process research and development expense.

PTC Therapeutics, Inc.

Summary Consolidated Balance Sheets

(in thousands, except share data)

September 30,

2026

December

31,

2025

Cash, cash equivalents and marketable securities

$2,127,918

$1,945,371

Total Assets

$3,207,715

$2,898,767

Total debt

$536,268

$286,631

Total deferred revenue

1,975

2,040

Total liability for sale of future royalties

2,305,603

2,308,366

Total liabilities

$3,398,924

$3,104,080

Total stockholders' deficit (83,535,767 and 81,474,366 common shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively)

$(191,209)

$(205,313)

Total liabilities and stockholders' deficit

$3,207,715

$2,898,767

PTC Therapeutics, Inc.

Reconciliation of GAAP to Non-GAAP Projected Full Year 2026 R&D and SG&A Expense

(in millions)

Low End of Range

High End of Range

Projected GAAP R&D and SG&A Expense

775

$815

Less: projected non-cash, stock-based compensation expense

Projected non-GAAP R&D and SG&A expense

$680

$720

Acronyms

AAV: adeno-associated virus

BLA: Biologics License Application

CHF: Confoederatio Helvetica Francs (Swiss francs)

DHODH: dihydroorotate dehydrogenase

FA: Friedreich’s ataxia

FDA: US Food and Drug Administration

GAAP: Generally Accepted Accounting Principles

HD: Huntington’s disease

MSH3: MutS Homolog 3 (human gene)

NDA: New Drug Application

NLRP3: NOD-, LRR- and pyrin domain-containing 3 (multi-protein complex)

R&D: Research and Development

SG&A: Selling, General, and Administrative

Today's Conference Call and Webcast Reminder

To access the live webcast, please visit the “Events & Presentations” page within the Investors section of the PTC website. A replay of the webcast will be available on the PTC website for 30 days following the event. To participate via phone, please register in advance here to receive dial-in details.

About PTC Therapeutics, Inc.

PTC is a global biopharmaceutical company dedicated to the discovery, development and commercialization of clinically differentiated medicines for children and adults living with rare disorders. PTC is advancing a robust and diversified pipeline of transformative medicines as part of its mission to provide access to best-in-class treatments for patients with unmet medical needs. The company's strategy is to leverage its scientific expertise and global commercial infrastructure to optimize value for patients and other stakeholders. To learn more about PTC, please visit www.ptcbio.com and follow on LinkedIn, X, Facebook and Instagram.

For more information please contact:

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 2026 Financial Guidance”, including with respect to (i) 2026 total product revenue guidance and total revenue guidance and (ii) 2026 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, meetings with regulatory agencies, commercialization and other matters with respect to 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," "aim," 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 Sephience, including commercialization and the potential achievement of sales milestones and contingent payments that PTC may be obligated to make; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in geographies in which it has been approved and the effect of the European Commission's adoption of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on Translarna and the withdrawal of the Translarna NDA in the US on other regulatory bodies; expectations with respect to PTC's license and collaboration agreement with Novartis Pharmaceuticals Corporation for votoplam for the treatment of Huntington's disease including its right to receive development, regulatory and sales milestones, profit sharing and royalty payments from Novartis, the design and expected timing of clinical trials and studies, the availability of data, and regulatory submissions and responses, including potential accelerated approval; expectations with respect to ST-920, including the expected timing of regulatory submissions and potential approvals, and the potential achievement of regulatory milestones and contingent payments PTC may be obligated to make; expectations with respect to Upstaza/Kebilidi, including commercialization, manufacturing capabilities, and the potential achievement of sales milestones and contingent payments that PTC may be obligated to make; expectations with respect to vatiquinone, including with respect to the design and expected timing of clinical trials and studies, the availability of data, and regulatory submissions and responses and potential approvals and other matters; expectations with respect to the commercialization of Evrysdi under PTC's SMA collaboration; expectations with respect to the commercialization of Tegsedi and Waylivra; expectations regarding PTC's product candidates, including the timing of clinical trials and studies; 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; 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 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 Sephience, Translarna, Emflaza, Upstaza, Kebilidi, 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.

EX-99.2

Filename: tmb-ex99d2.htm · Sequence: 3

Exhibit 99.2

PTC Therapeutics

October 2026

This presentation contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this presentation, other than

statements of historic fact, are forward-looking statements, including with respect to 2026 total product revenue guidance and total revenue guidance and 2026 operating 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, meetings with regulatory agencies, commercialization and other matters with respect to 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," "aim," 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 Sephience, including commercialization and the potential achievement of sales milestones and contingent

payments that PTC may be obligated to make; PTC's ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in geographies in which it has been approved and

the effect of the European Commission's adoption of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP) on Translarna and the withdrawal of the Translarna

NDA in the US on other regulatory bodies; expectations with respect to PTC's license and collaboration agreement with Novartis Pharmaceuticals Corporation for votoplam for the treatment of

Huntington's disease including its right to receive development, regulatory and sales milestones, profit sharing and royalty payments from Novartis, the design and expected timing of clinical trials

and studies, the availability of data, and regulatory submissions and responses, including potential accelerated approval; expectations with respect to ST-920, including the expected timing of

regulatory submissions and potential approvals, and the potential achievement of regulatory milestones and contingent payments PTC may be obligated to make; expectations with respect to

Upstaza/Kebilidi, including commercialization, manufacturing capabilities, and the potential achievement of sales milestones and contingent payments that PTC may be obligated to make;

expectations with respect to vatiquinone, including with respect to the design and expected timing of clinical trials and studies, the availability of data, and regulatory submissions and responses

and potential approvals and other matters; expectations with respect to the commercialization of Evrysdi under PTC's SMA collaboration; expectations with respect to the commercialization of

Tegsedi and Waylivra; expectations regarding PTC's product candidates, including the timing of clinical trials and studies; 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; 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 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 Sephience, Translarna, Emflaza, Upstaza, Kebilidi, Evrysdi, Tegsedi or

Waylivra.

The forward-looking statements contained herein represent PTC's views only as of the date of this presentation 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 presentation except as required by

law.

Forward Looking Statements

PTC: A Global Leader in Rare Disease Drug

Development and Commercialization

1As of September 30, 2026 3

Robust global

commercial

infrastructure

Proven track record

of achieving regulatory

authorization, gaining

market access and

commercializing rare

disease therapies in

over 50 countries.

Lead product

Sephience

supports near- and

mid-term growth

Strong initial global

launch and positioned

to be new standard of

care for PKU. IP into

2039 and $2B+ global

revenue potential.

Innovative R&D

platforms and

pipeline

Pioneered field of

oral small molecule RNA

splicing with proprietary

platform engine to

accelerate and facilitate

next generation of oral

small molecule splicing

therapies.

Strong financial

position

Cash balance of

$2.1B1 and on track to

achieve 2026 cash flow

breakeven and future

sustainable profitability.

2026 Strategic Priorities

Continue

Sephience

global launch

momentum

Move toward

reaching cash

flow breakeven

Advance

Phase 3

votoplam HD

program

Advance

early-stage

R&D programs

2026 Revenue and OpEx Guidance

Product Revenue1

OpEx $680 - 720M 3

$1.29 - 1.32B

$960 - 990M

64 - 69% YoY Growth

Total Revenue2

Our Products4

1 Product revenue excludes Evrysdi royalty and collaboration revenues; YoY based on $960-990M guidance.

2 Total revenue includes Evrysdi royalty and collaboration revenues.

3 OpEx is a non-GAAP measure that includes only R&D and SG&A expenses for full year 2026, and excludes estimated non-cash, stock-based

compensation expense of approximately $95M. GAAP R&D and SG&A expense for full year 2026 is anticipated to be between $775 and $815M.

4 PTC holds the commercialization rights for Tegsedi and Waylivra in Latin America and the Caribbean from Ionis Pharmaceuticals.

Katie, living with PKU

Sephience

PKU Program

Sephience Dual Mechanism of Action Supports

Potential for Broad Uptake

1. Precursor to BH4

Sephience

7.8-Dihydrobiopterin (BH2

)

Tetrahydrobiopterin (BH4

)

SR*

DHFR**

BH BH4 4 BH4

Sephience significantly increases

intracellular BH4

levels

2. Independent Chaperone Function

Misfolded

PAH Enzyme

Chaperone

Effect

Decreased

Enzyme

Activity

Increased

Enzyme

Activity

Chaperone effect stabilizes enzyme, increases function,

and enables treatment of BH4

-non-responsive mutations

* SR, sepiapterin reductase (enzyme that converts Sephience to BH2

)

** DHFR, dihydrofolate reductase (enzyme that converts BH2

to BH4

)

Lah, M. Advances in Therapy (In press)

Sephience Provides Significantly Greater

Phe Reduction Compared With BH4

-437.0 -256.6

-600

-500

-400

-300

-200

-100

100

Absolute least squares mean change

in blood Phe concentration (µmol/L)

Sephience BH4

70.3%

Greater reduction

with Sephience

p < 0.0001

Mean Absolute Change in Blood Phe from Baseline

AMPLIPHY was a crossover study allowing for intra-subject

comparison of Sephience and BH4 treatment effect

Lancet. 2024 Oct 5;404(10460):1333-1345. doi: 10.1016/S0140-6736(24)01556-3.

Sephience Provides Diet Liberalization,

Cognitive and Quality of Life Benefits

Improved cognitive

function and mood

Improved concentration

& slow thinking, and

decreased irritability

Meaningful diet

liberalization

69% of subjects

reached age-adjusted protein RDA

Improved

quality of life

Reduced disease

impact on emotional,

social, and familial

wellbeing

Genet Med. 2026 Apr;28(4):101683. doi: 10.1016/j.gim.2026.101683. Epub 2026 Jan 12.

Sephience Differentiated Profile Enables Penetration

Into All Key Market Segments

On Treatment Treatment Failures Treatment Naive

58K Patients WW

T O TA L A D D R E S S A B L E M A R K E T

I N C L U D I N G A L L A G E S A N D S E V E R I T I E S

Sephience: Strong Launch Momentum Continues

* As of September 30, 2026 11

$458M Global revenue YTD

in first full year of launch

Broad penetration into

all key market segments

Sephience Global Launch Footprint Expansion

Planned for 2026 and 2027

N O R T H

A M E R I C A

E U R O P E A S I A

L AT A M

Anticipated Sephience geographic footprint for 2026

ST-920

Fabry Disease Program

• Lysosomal storage disorder causing serious

organ damage, leading to premature death

• Affects ~11,000 individuals (US)

• Standard of care of enzyme replacement

therapies (ERT) have several drawbacks

− Frequent (up to biweekly) administration

− Require immunosuppression

− Risk of antibody formation limiting ERT benefits

• A one-time administered gene therapy has

potential to provide benefits of ERT

without current burdens and risks

Fabry Disease is a Rare, Life-Shortening Disorder

with Multiorgan Impact

Organ

involvement

includes

kidney, heart

and brain

• AAV gene therapy that provides humanized

gene enabling long-term production of the

deficient α-Gal A enzyme

• Favorable safety profile with no need for

immunosuppression

• Durable α-Gal A activity with longest follow up

of over 5 years

• Favorable effects on renal function and other

disease aspects following gene therapy

administration

ST-9201

Provides One-Time Administered

Durable Enzyme Production

BLA submission

for accelerated

approval expected to

be completed in

Q4 2026

1 Isaralgagene civaparvovec

April, living with HD

Votoplam

Huntington’s Disease Program

Phase 2 PIVOT-HD Trial Achieved Key Efficacy and

Safety Objectives

17 17

Evidence of

dose-dependent

disease slowing

on cUHDRS in

Stage 2 participants

at 24 months

PIVOT-HD study met

primary endpoint

of blood HTT protein

lowering at Week 12

with durable dose-dependent lowering

at Month 12

Continued evidence

of favorable

safety profile

with no new AE

signals identified for

both dose levels and

stages at 24 months

Dose-dependent Slowing of Disease Progression on

cUHDRS at 24 months in Stage 2 ParticipantsWorsening

Results based on observed data

SE = Standard Error

Baseline 12 Month 24 Month

Mean (+/-SE) Change from

Baseline of Composite UHDRS

-0.5

-1.0

-1.5

NH Cohort

Votoplam

5 mg

Votoplam

10 mg

Mean difference in

cUHDRS progression of

52% (10mg) and 28% (5mg)

at Month 24

Treatment Group Mean (SE) Mean (SE)

-1.20 (0.20)

-0.86 (0.24)

-0.57 (0.24)

-0.58 (0.15)

-0.42 (0.16)

-0.34 (0.21)

Natural History (N=73)

5 mg (N=21)

10 mg (N=24)

Results from PIVOT-HD LTE (April 2026) 18

INVEST-HD Global Phase 3 Trial Enrolling Worldwide

19 19

• Individuals with early symptomatic disease

• 3:2 randomization of votoplam 10mg: placebo

• Target enrollment: ~770 participants in >30 countries

• Primary endpoint: Change from baseline in cUHDRS

• Treatment period up to 36 months

• Interim analysis planned for efficacy and futility

Study Overview

*Study sponsored and funded by Novartis; NCT#: NCT07326709

Olivia, living with FA

Vatiquinone

Friedreich’s Ataxia Program

Vatiquinone Demonstrated Meaningful Slowing

of Short- and Long-term Disease Progression

Vatiquinone

Placebo

Long-term Extension Studies

4.8-point benefit (p<0.0001)

on mFARS** over 2 years

in ambulatory and non-ambulatory adults

50% slowing (p<0.0001) of

disease progression over

3 years** in MOVE-FA long-term extension study

72-week Placebo-Controlled MOVE-FA Trial*

Weeks

Mean change from Baseline in mFARS

Upright Stability score (+/- SE)

42%

Slowing

p=0.021

* MOVE-FA did not meet its primary endpoint of statistically significant change in total mFARS at 72 weeks

** Relative to matched FACOMS (Friedreich’s Ataxia Clinical Outcome Measures Study) natural history cohort

PROVE-FA Phase 3 Open-Label Study to Support

NDA Resubmission Initiated in Q3 2026

• Open-label study using matched natural history

cohort from FACOMS disease registry

• Target enrollment: 120 individuals with FA

ages 7 to 21

• Primary endpoint: Change in mFARS from

baseline to 24 months

Study Overview

Innovative

Research Platforms

R&D Pipeline Includes Innovative Programs from

Differentiated Scientific Platforms

MSH3: Huntington’s Disease, Myotonic Dystrophy I

Undisclosed: Alzheimer’s Disease

Undisclosed: Brain Tumors & Metastases

Undisclosed: Sickle Cell Disease, -Thalassemia

Oral Small Molecule

Splicing Platform

Inflammation/

Ferroptosis Platform

Ferroptosis: Multisystem Atrophy (MSA) & Parkinson’s Disease

NLRP3 Inflammasome: Inflammatory Lung Diseases

DHODH Inhibition: T-Cell Mediated Autoimmune Diseases

NRF2 Activation: CNS, Non-CNS Indications

Undisclosed: Neurodegenerative Diseases

• MSH3 is a genetic modifier of repeat expansion disorders such as HD and DM1

• Validated correlation between MSH3 reduction and HD onset and progression, supporting therapeutic potential

of MSH3 reduction

• PTC303 to enter clinic in 2027

PTC303 MSH3 Small Molecule Splicing Program

0 5 10 15

Delay in motor onset (years) Redcution in MSH3 expression

3a/3a

5AM2

E233

IY461-462

Clear linear

correlation

between

magnitude of

MSH3 reduction

and HD

progression

in patients1

In HD

mice, 50%

knockdown

of MSH3 halts

somatic

expansion in

the striatum2

Similar correlation for DM1

1. Flower. M et al. Brain. 2019 Jun 19;142(7):1876–1886. 2. Antonijevic, I. A. et al. (2022)

• NLRP3 is an intracellular sensor protein that detects infection, stress or tissue damage

• Upon detection, NLRP3 is activated, triggering the assembly and activation of the

NLRP3 inflammasome leading to elevated levels of IL-1β and IL-18

• Aberrant NLRP3 activation is implicated in a wide range of inflammatory diseases

• PTC612 is differentiated from other NLRP3 inhibitors in terms of potency, selectivity

and chemical structure

• PTC612 Phase 1 SAD/MAD healthy volunteer study ongoing including cohort of

individuals with metabolic syndrome to provide initial evidence of PK/PD effect

PTC612 NLRP3 Inhibitor Program

PTC612: Greater Potency & Selectivity Compared to

Other NLRP3 Inhibitors

Assay PTC612 Selnoflast1 DFV8902 Usnoflast3 AZD41444

THP-1

IL1β IC50 (nM) 0.99 220 13 13 23-82

Assay PTC612 Vent-015 DFV8902 VTX-32326 VTX-27356

hWB

IL1β IC50 (nM)

9.7 124 180 13 80

PTC612 Demonstrates >10x Potency and Selectivity vs Other NLRP3 Inhibitors

1. In house data; 2. JMC 2025; 3. Brain Res 2024; 4. JMC 2025; 5. Inflammasome Summit 2022; 6. Ventyx Corporate Presentation June 2023

• DHODH plays a critical role in inflammation by regulating the proliferation of immune

cells and modulating cytokine production

• Marketed DHODH inhibitors have limitations due to lack of specificity and

associated toxicity

• PTC844 is a more potent and selective DHODH inhibitor, potentially improving efficacy,

safety and tolerability

• PTC844 Phase 2a study initiated in Q3 2026

− 12-week PK/PD study to assess treatment effect on biomarkers and inform target indications

PTC844 DHODH Inhibitor Program

PTC844 Demonstrates Superior Potency and

Selectivity Compared to Other DHODH Inhibitors

Phase 2a PK/PD study of PTC844 initiating Q3 2026

[nM]

IC50=1nM IC50~5000nM

[nM]

IC50>10,000nM

[nM]

PTC844 Vidofludimus Teriflunomide

Well Positioned for Success in 2026 & Beyond

Robust global

commercial

infrastructure

Strong

financial

position

Lead product

Sephience

to support near-and mid-term

growth

Innovative

R&D platforms

and pipeline

PTC Therapeutics

October 2026

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Oct. 29, 2026

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PTC THERAPEUTICS, INC.

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