KRYS

EX-99.1

2 exhibit991-3q26pressrelease.htm

EX-99.1

Document

Krystal Biotech Announces Third Quarter 2026 Financial and Operating Results

$127.3 million in 3Q VYJUVEK global revenue and $1.1 billion since launch

VYJUVEK pricing negotiations in Germany and Italy completed

KB113 clinical data demonstrate regression in more than 80% of assessed basal cell carcinoma lesions in patients with Gorlin syndrome

Strong balance sheet, ending the quarter with $1.2 billion in cash and investments

Board authorizes share repurchase program of up to $400 million

PITTSBURGH, November 2, 2026 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company” or “Krystal”) (NASDAQ: KRYS) today reported financial results for the third quarter ended September 30, 2026 and provided a business update.

“Continued growth in VYJUVEK revenue is supporting profitability and funding the advancement of our pipeline,” said Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech. “Our financial strength allows us to invest fully in these programs and our global commercial expansion while returning capital to shareholders. The $400 million share repurchase program, under which we expect to repurchase shares opportunistically over the next two years, reflects our confidence in Krystal’s long-term growth prospects and our commitment to disciplined capital allocation.”

VYJUVEK® (beremagene geperpavec-svdt, or B-VEC)

for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

The Company recorded $127.3 million in global VYJUVEK net product revenue for the third quarter of 2026, an increase of 30% compared to the prior year third quarter. Gross margin for the quarter was 94%.

Patient demand in the United States continues to grow with over 760 reimbursement approvals secured for VYJUVEK nationwide. Steady expansion of the U.S. prescriber base is supporting continued adoption across the country.

The Company is also expanding its reach across its initial launch markets of Germany, France, and Japan, converting high physician interest and engagement into patient starts and broadening the prescriber base to bring VYJUVEK treatment closer to patients.

Pricing negotiations are now complete in both Germany and Italy, and the Company expects to launch VYJUVEK in Italy in early 2027. Pricing negotiations are ongoing in multiple European countries and the United Kingdom, with decisions expected in Spain later this year, and in France no earlier than 2027. The Company has also submitted a marketing authorization application for VYJUVEK in Australia and expects to submit an application for marketing authorization in Switzerland before year end.

Dermatology

KB111 for the treatment of Hailey-Hailey disease (HHD)

Enrollment is complete and dosing is ongoing in HALITE-1, the Company’s open-label, single-arm study evaluating the safety of KB111, administered once weekly for 12 weeks, in patients with HHD. HHD is a genetic disease characterized by painful rash and blistering in skin folds. In addition to pain, patients with HHD reporting debilitating symptoms of itch, burning, infections, and body odor, as well as severe, negative impacts on quality of life and psychological distress. The prevalence of HHD is not well characterized and is most commonly estimated at roughly 1 per 50,000, although underreporting is possible.

A total of five patients have been enrolled in HALITE-1. The Company expects to report interim study results before the end of the year. Details of the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07717346.

The Company has also completed development of its HHD-specific severity scale for the clinical evaluation of KB111. The Company expects to meet with the FDA in the first quarter of 2027, following completion of scale validation, to discuss study results, the scale, and study designs to enable a registrational study start in 2027.

KB113 for the treatment of Gorlin syndrome (GS)

In October, the Company announced a positive clinical update supporting initial proof of concept for KB113 in the treatment of basal cell carcinoma (BCC) in patients with GS. GS is a genetic disease characterized by a greatly increased risk of developing BCCs. Patients with Gorlin syndrome can develop BCCs as early as infancy and may have hundreds of BCCs over their lifetimes requiring frequent and potentially disfiguring surgical procedures. Prevalence data for GS is limited but available data suggest the number of patients with GS in the United States could exceed 10,000.

In the Company’s three patient pilot, multicenter, single-arm, open-label study, more than 80% of assessed BCC lesions showed investigator-assessed clinical regression. Regression was observed in both injected and non-injected lesions, consistent with an abscopal effect. Histologic assessment also confirmed complete clearance of an injected BCC lesion in each patient. KB113 was well tolerated, with all reported adverse events mild or moderate in

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krys-20260217FALSE000171127900017112792025-11-032025-11-03

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) February 17, 2026

KRYSTAL BIOTECH, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

2100 Wharton Street, Suite 701 Pittsburgh, Pennsylvania 15203 (Address of principal executive offices)(Zip Code) Registrant’s telephone number, including area code (412) 586-5830

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:

☐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 classTrading Symbol(s)Name of each exchange on which registered Common StockKRYSNasdaq 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 February 17, 2026, Krystal Biotech, Inc., a Delaware corporation (the “Company”), announced its financial results for the quarter and year ending December 31, 2025. A copy of the Company’s press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

The information concerning financial results in this Form 8-K and in Exhibit 99.1 attached hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information concerning financial results in this Form 8-K and in Exhibit 99.1 attached hereto shall not be incorporated into any registration statement or other document filed with the Securities and Exchange Commission by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.  Description

99.1  Press Release, dated February 17, 2026

104Cover Page Interactive Data file (embedded within the Inline XBRL document)

SIGNATURES

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.

Date: February 17, 2026

KRYSTAL BIOTECH, INC.

By: /s/ Krish S. Krishnan Name: Krish S. Krishnan Title: Chairman and Chief Executive Officer