[8-K] Krystal Biotech, Inc. Reports Material Event

Rhea-AI Filing Summary

Krystal Biotech (KRYS) announced that its wholly owned subsidiary, Krystal Biotech Japan KK, commenced the commercial launch of VYJUVEK (beremagene geperpavec) in Japan effective October 22, 2025. The launch follows VYJUVEK’s inclusion on Japan’s National Health Insurance Drug Price List the same day, enabling reimbursed access for the treatment of dystrophic epidermolysis bullosa. VYJUVEK is listed at 2,955,232.7 yen per unit. The company stated this information is furnished for informational purposes.

Insights

Biopharma commercialization analyst

Japan launch begins with NHI price set at ¥2,955,232.7.

Krystal Biotech’s Japan subsidiary began commercial sales of VYJUVEK after its addition to the NHI Drug Price List. NHI listing typically permits national reimbursement, a key prerequisite for broad patient access in Japan.

The filing specifies a unit price of 2,955,232.7 yen and the indication of dystrophic epidermolysis bullosa. Actual sales dynamics will be determined by clinical adoption and eligible patient volumes, which are not detailed in the excerpt.

The effective date is October 22, 2025, marking the start of commercial availability in Japan following reimbursement listing.

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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 22, 2025

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 Number)

2100 Wharton Street, Suite 701

Pittsburgh, Pennsylvania 15203

(Address of principal executive offices, including 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 class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

KRYS

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 8.01    Other Events

Krystal Biotech, Inc. today reported that, effective as of October 22, 2025, its wholly owned subsidiary, Krystal Biotech Japan KK, commenced the commercial launch of VYJUVEK® (beremagene geperpavec) in Japan for the treatment of dystrophic epidermolysis bullosa following its inclusion on Japan’s National Health Insurance (NHI) Drug Price List on the same date. VYJUVEK has been listed on the NHI Drug Price List at a price of 2,955,232.7 yen per unit. This Current Report on Form 8-K is being furnished for informational purposes only.

SIGNATURES

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

Date: October 22, 2025

KRYSTAL BIOTECH, INC.

By:

/s/ Krish S. Krishnan

Name:

Krish S. Krishnan

Title:

Chairman and Chief Executive Officer

FAQ

What did KRYS announce regarding VYJUVEK in Japan?

Krystal Biotech’s subsidiary began the commercial launch of VYJUVEK in Japan effective October 22, 2025 after NHI price listing.

What is the NHI-listed price for VYJUVEK per unit in Japan?

VYJUVEK is listed at 2,955,232.7 yen per unit on Japan’s NHI Drug Price List.

Which indication is VYJUVEK approved to treat in this launch?

The launch is for the treatment of dystrophic epidermolysis bullosa.

Which KRYS entity is responsible for the Japan launch?

The launch is led by Krystal Biotech Japan KK, a wholly owned subsidiary.

When did the commercial launch and NHI listing take effect?

Both took effect on October 22, 2025.

Is this disclosure presented as informational?

Yes. The company states the information is furnished for informational purposes.