KRYS · 10-K filed 17 Feb 2026 · year to 31 Dec 2025

Krystal Biotech

29 named things its latest annual report says its results depend on, each in the company's own words. 14 of them are also named by other companies we've read.

Read the filing on SEC.gov ↗

Suppliers

Sterile gel third-party manufacturer

depends onnamed as a risk

For example, we use a third-party to manufacture the sterile gel that is mixed with our in-house produced vector for VYJUVEK.Risk factors (Item 1A)

Partners and platforms

Specialty pharmacy provider

depends onnamed as a risk

For example, in 2024, our specialty pharmacy provider was affected by a cybersecurity incident that delayed reimbursement approvals and had a negative impact on our product revenue.Risk factors (Item 1A)

Third-party logistics and specialty pharmacies (U.S. distribution)

depends onnamed as a risk

We rely on a small number of third parties to commercially distribute VYJUVEK to patients in the United States.Risk factors (Item 1A)

Specialty distributors (Central and Eastern Europe, Middle East, Turkey, Israel)

depends onnamed as a risk

Outside of the United States, major European markets, and Japan, we have entered into distribution agreements with specialty distributors to commercialize VYJUVEK.Risk factors (Item 1A)

Cystic Fibrosis Foundation Therapeutic Development Network

depends on

We are now working with the TDN on a repeat dosing study design, CORAL-3, which was submitted to the FDA in December 2025.Business (Item 1)

Other companies

ANCORIS manufacturing facility

operates innamed as a risk

Failure or delay in technical transfer of VYJUVEK or another approved product from ANCORIS to ASTRA, or from ASTRA to ANCORIS, could impair our ability to supply sufficient product to meet commercial demand and successfully commercialize and generate revenue from sales of approved products, which could adversely affect our business, financial condition, and results of operations.Risk factors (Item 1A)

Competitors

Abeona Therapeutics Inc.

competes withnamed as a risk

Abeona Therapeutics Inc.’s autologous gene therapy product Zevaskyn® (prademagene zamikeracel) was approved by the FDA in 2025.Business (Item 1)

Chiesi Farmaceutici S.p.A.

competes withnamed as a risk

Chiesi Farmaceutici S.p.A.’s palliative treatment Filsuvez® (birch triterpenes) was approved by the FDA in 2023 and was previously approved by the EMA.Business (Item 1)

Castle Creek Biosciences, Inc.

competes withnamed as a risk

We are aware of companies, Abeona Therapeutics Inc. and Castle Creek Biosciences, Inc., which are developing or have commercialized autologous or grafting gene therapy approaches to treating DEB.Business (Item 1)

Dompé farmaceutici S.p.A.

competes withnamed as a risk

Dompé farmaceutici S.p.A,’s Oxervate® (cenegermin) was approved by the FDA in 2018 and by the EMA in 2017.Business (Item 1)

Places

United States

earns from · $730.3 million in net product revenue

Since our first commercial launch of VYJUVEK in the United States, we have reported $730.3 million in net product revenue.Business (Item 1)

Also named by ABBV, ADP, AJG, AMGN, APA, AXGN, AXP, BALL and 139 more

Germany

earns fromnamed as a risk

Pricing negotiations are underway in both Germany and France and are expected to continue until at least the second half of 2026 in Germany and until 2027 in France.Business (Item 1)

Also named by APO, AXGN, BF/B, CPRT, DASH, EBAY, GD, GDDY and 12 more

Italy

earns fromnamed as a risk

We are advancing pricing discussions with Italian reimbursement authorities to enable a potential launch in Italy in the second half of 2026.Business (Item 1)

Also named by ABNB, CMCSA, HLIO, JEF, JOUT, RL, ROK

Pittsburgh, Pennsylvania

concentrated innamed as a risk

A significant portion of our current supply of materials necessary for production of VYJUVEK and our product candidates, as well as finished VYJUVEK and product candidates, is located at our manufacturing facilities in Pittsburgh, Pennsylvania.Risk factors (Item 1A)

Japan

earns from

We are commercializing VYJUVEK directly in the United States, major European markets, and Japan.Business (Item 1)

Also named by A, AAPL, AFL, AMKR, ANET, BMY, BSX, CAT and 25 more

Commodities and inputs

Biologically derived raw materials

depends onnamed as a risk

Some of the raw materials required in our manufacturing process are derived from biologic sources.Risk factors (Item 1A)

Regulators

U.S. Food and Drug Administration (FDA)

subject tonamed as a risk

Although we received approval from the U.S. Food and Drug Administration, or FDA, the European Commission, and Japan's Ministry of Health, Labour and Welfare, or MHLW, for VYJUVEK for the treatment of dystrophic epidermolysis bullosa, or DEB, we can provide no assurances that we will obtain regulatory approval in any other jurisdiction, which could have an adverse impact on our results of operations.Risk factors (Item 1A)

Also named by A, ABBV, ABT, AMGN, ARE, ARWR, ATR, AXGN and 112 more

European Commission

subject to

On April 23, 2025, the European Commission (the “EC”) granted marketing authorization to VYJUVEK for the treatment of wounds in patients with DEB starting from birth.Business (Item 1)

Also named by AAPL, BKNG, CCK, FWONA, IONS, META, MRNA, TEX and 1 more

European Medicines Agency (EMA)

subject to

In February 2024, the EMA completed inspection of our ANCORIS facility as part of the marketing authorization application review process and, in May 2024, European Union good manufacturing practice certification was granted by the EMA.Business (Item 1)

Also named by GEHC, GILD, INCY, MEDP, TMO, VKTX, WST, ZTS

Japan Ministry of Health, Labour and Welfare (MHLW)

subject to

In October 2025, we launched VYJUVEK in Japan following successful completion of pricing negotiations with Japan’s Ministry of Health, Labour and Welfare (“MHLW”).Business (Item 1)

Also named by COO, GH, ISRG

Laws and programs

Biologics Price Competition and Innovation Act (BPCIA)

subject to · 12-year period of exclusivitynamed as a risk

However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our investigational genetic medicines to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated.Risk factors (Item 1A)

Also named by ABBV, AMGN

EU orphan market exclusivity reform

subject to · nine years (as opposed to the current ten years)named as a risk

Pursuant to a recent legislative reform initiative of the pharmaceutical framework, for which a provisional political agreement has been reached between the European Parliament and the Council in December of 2025, exclusivity for new orphan medicinal products will likely run nine years (as opposed to the current ten years), while "breakthrough" orphan medicinal products addressing diseases with no existing treatments can benefit from up to 11 years of market exclusivity.Risk factors (Item 1A)

Rare Pediatric Disease Priority Review Voucher program

earns from · $100 million

We sold the PRV in the third quarter of 2023 for $100 million.Business (Item 1)

Also named by IONS, MRNA

Medicare

earns fromnamed as a risk

Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors.Risk factors (Item 1A)

Also named by ABT, ARWR, AXGN, BAX, BDX, BMY, BSX, CAH and 48 more

Medicaid

earns fromnamed as a risk

On July 4, 2025, legislation commonly referred to as the One Big Beautiful Bill Act was signed into law, which reduces funding to federal healthcare programs and imposes additional requirements to be eligible for healthcare, which may result in decreased access to healthcare, particularly in Medicaid programs.Risk factors (Item 1A)

Also named by ABBV, ABT, ARE, ARWR, BAX, BMY, BSX, CHE and 39 more

Inflation Reduction Act (IRA)

subject tonamed as a risk

At this time, we continue to evaluate the effect of the IRA and the Trump administration’s executive actions on our business operations and financial condition and results as the full impact of the IRA and the executive actions remains uncertain.Risk factors (Item 1A)

Also named by AEE, AMGN, ARWR, BIIB, BKNG, BMY, CAH, CI and 26 more

Orphan Drug Act

subject tonamed as a risk

If we are unable to maintain or obtain orphan drug exclusivity, our ability to generate sufficient revenue may be negatively affected.Risk factors (Item 1A)

Also named by ARWR, IONS, NBIX, PVLA, UTHR, VKTX

France Accès Précoce program

earns from

In August 2025, we launched VYJUVEK in Germany, our first commercial launch outside the United States, and in October 2025, we launched VYJUVEK in France under the post-marketing authorization early reimbursed access Accès Précoce program.Business (Item 1)

FDA platform technology designation

subject to

Reflecting this increasing familiarity, in October 2025, the FDA granted platform technology designation to our genetically modified, non-replicating HSV-1 viral vector used in our product candidate, KB801 for the treatment of neurotrophic keratitis.Business (Item 1)