Krystal Biotech, Inc. (KRYS): Business Model Canvas [Dec-2025 Updated]

You're looking at Krystal Biotech, Inc. (KRYS) and trying to figure out its real financial engine as of late 2025. Honestly, it boils down to one thing: the successful launch of their gene therapy, Vyjuvek, which is already generating serious cash to fund the next wave of drugs. With $282.0 million in net product revenue through the first nine months of 2025, and a stunning 96% gross margin reported in Q3 2025, the commercial execution is clear. So, if you want to see exactly how this rare disease play is structured-from its proprietary manufacturing to its high-touch patient support-dive into the full Business Model Canvas below.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Key Partnerships

You're looking at how Krystal Biotech, Inc. scales its commercial and R&D efforts through external relationships. It's not just about what they make; it's about who helps them get it to patients and who validates the science. This network is crucial for a gene therapy company transitioning to global scale.

Specialty Pharmacies and Distributors for Cold Chain Logistics and Patient Access

Getting VYJUVEK to the patient requires a specialized supply chain, especially for a topical gene therapy that needs careful handling. Krystal Biotech, Inc. established a limited distribution network in the US. Option Care Health was selected to be part of this network, using its national footprint of over 95 specialty pharmacies across the US to mix and deliver the prepared VYJUVEK gel syringes.

This distribution is often supported by home healthcare partners; Option Care Health collaborates with Amedisys, Inc. for the delivery and administration of VYJUVEK by nurses in professional healthcare or home settings. For broader logistics, the company relies on the major wholesale distributors that dominate the pharmaceutical space, such as McKesson, AmerisourceBergen/Cencora, and Cardinal Health, all of which maintain specialty distribution operations.

Internationally, Krystal Biotech, Inc. is building out its distribution for the rest of the world, having executed agreements with leading regional specialty distributors covering key markets in the Middle East, Turkey, and Central and Eastern Europe.

Global Regulatory Bodies (FDA, EMA, Japan's MHLW) for Product Approvals and Label Expansion

Regulatory partnerships are foundational, validating the technology and opening markets. Krystal Biotech, Inc.'s first product, VYJUVEK, is approved by the FDA (May 2023), the European Medicines Agency (EMA) via the European Commission (EC) (April 23, 2025), and Japan's Ministry of Health, Labour and Welfare (MHLW) (July 2025).

The FDA partnership resulted in a September 2025 label update, expanding the eligible patient population to include DEB patients from birth and allowing patients or caregivers to apply VYJUVEK at home. The EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in February 2025. Furthermore, in France, VYJUVEK received an ASMR III designation from the HAS, which acknowledges added clinical benefit and aids pricing discussions. The FDA also granted platform therapy designation to Krystal Biotech, Inc.'s HSV-1 gene delivery platform.

Academic and Clinical Research Institutions for Ongoing Clinical Trials (e.g., KB407 for CF)

Advancing the pipeline requires collaboration with leading research centers. For the KB407 program targeting cystic fibrosis (CF), the Cystic Fibrosis Foundation (CFF) Therapeutic Development Network (TDN) Clinical Research Executive Committee granted full sanctioning to the Phase 1 CORAL-1 study protocol.

The clinical trial progression involves sequential cohorts, with interim molecular data for Cohort 3 patients expected in Q4 2025. Earlier cohorts (1 and 2) demonstrated that single and repeat doses of KB407 were safe and well-tolerated.

Healthcare Payers and Government Agencies for Securing Over 615 US Reimbursement Approvals

Securing payment pathways is as critical as regulatory approval for commercial success. As of the third quarter of 2025, Krystal Biotech, Inc. had secured over 615 reimbursement approvals for VYJUVEK across the United States. This number reflects continued acceleration, with the team adding over 40 new approvals since the prior earnings call. This access supports the total net VYJUVEK revenue since launch, which exceeded $623 million through the end of Q3 2025.

Distribution Partners in New International Markets like Europe and Japan

Global expansion is actively being executed through direct launches and distributor networks. Krystal Biotech, Inc. launched VYJUVEK in Germany in late August 2025, with subsequent launches in France and Japan occurring in Q4 2025.

The international partnership landscape includes specific milestones:

• Japan: Pricing negotiations were completed in late October 2025.
• Germany: Approximately 20 patients were prescribed VYJUVEK since the late-August launch as of early November 2025.
• France: The product received the ASMR III designation.

The company is also exploring partnerships for other regions, having planned to submit regulatory applications in the UK mid-year 2025 and exploring distributor relationships in the Middle East and North Africa.

Here's a snapshot of the global commercial footprint as of late 2025:

Finance: draft 13-week cash view by Friday.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Key Activities

You're managing the transition from a single-product company to a global commercial entity; that means your Key Activities are all about execution, scale, and pipeline advancement. Here's the quick math on what Krystal Biotech, Inc. was actively doing as of late 2025, based on their Q3 reporting.

Manufacturing of the proprietary HSV-1-based gene therapy (Vyjuvek)

The core activity here is maintaining the high quality and scale needed for commercial supply. Krystal Biotech, Inc. achieved a very strong gross margin on this activity in the third quarter of 2025, which shows operational efficiency is improving as they scale up the U.S. process.

• Gross margin for the third quarter of 2025 was reported at an impressive 96%.
• Cost of goods sold for the third quarter of 2025 was $4.3 million.

Global commercialization and launch execution in the US, Germany, France, and Japan

This is where the rubber meets the road-turning regulatory success into revenue across borders. The U.S. market remains the primary driver, but the late 2025 launches in Europe and Japan are critical for long-term growth. What this estimate hides is the complexity of establishing supply chains in new territories.

Here's a look at the commercial performance leading up to the end of Q3 2025:

Research and development (R&D) for pipeline candidates (e.g., KB407, KB803)

Krystal Biotech, Inc. is actively funding the next generation of therapies using its platform. You need to track these expenses against near-term clinical milestones to gauge the burn rate supporting future value creation. The company is definitely pushing hard on its pipeline readouts.

• Research and development expenses for the third quarter of 2025 totaled $14.6 million.
• R&D expenses for the first nine months of 2025 were $43.3 million.
• Interim clinical results for the Cystic Fibrosis (KB407) program were expected in 4Q 2025.
• Preclinical data for KB111 (for Hyperhidrosis and Dyshidrosis) supported dosing patients in a study in 1H 2026.

Securing and maintaining regulatory approvals and expanded labels (e.g., DEB patients from birth)

Regulatory maintenance and expansion are crucial for maximizing the addressable patient population for Vyjuvek. The label update in September 2025 was a significant win for patient access and flexibility.

• In September 2025, the FDA approved a label update for Vyjuvek.
• The update expanded eligibility to Dystrophic Epidermolysis Bullosa (DEB) patients from birth.
• The label also provided greater flexibility, allowing patients or caregivers the option to apply Vyjuvek at home.

High-touch patient support and reimbursement navigation services

Getting the drug approved is one thing; getting it paid for and used correctly is another. Krystal Biotech, Inc. focuses heavily on ensuring patients can access and adhere to the therapy, supported by their dedicated patient support team.

• The company had secured over 615 reimbursement approvals for Vyjuvek in the United States as of September 30, 2025.
• This represents an increase from over 575 approvals reported at the end of the second quarter of 2025.
• The company utilizes the CrystalConnect patient support team to help activate new patients and maintain relationships.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Key Resources

You're looking at the core assets Krystal Biotech, Inc. is using to drive its business forward, especially now that Vyjuvek is generating revenue and the pipeline is advancing. These aren't just abstract concepts; they are concrete, measurable resources backing their strategy.

Vyjuvek (beremagene geperpavec-svdt), the first redosable gene therapy for DEB

Vyjuvek is the crown jewel resource, representing market validation for the entire platform. The financial performance shows real traction in the rare disease space. For the third quarter ending September 30, 2025, Krystal Biotech recorded net product revenue of $97.8 million from Vyjuvek. That quarter's gross margin hit 96%. Since its U.S. launch, total net VYJUVEK revenue has surpassed $623.2 million. Also, the U.S. label update in September 2025 expanded the eligible patient population to include DEB patients from birth, which is a significant expansion of the addressable market. The company also secured over 615 reimbursement approvals in the United States as of that date.

Here's a quick look at the recent product performance:

The commercial footprint is also expanding internationally; Krystal Biotech launched VYJUVEK in Germany in the third quarter of 2025, with launches in France and Japan following in the fourth quarter of 2025.

Strong cash and investments balance of $864.2 million as of September 30, 2025

Liquidity is a massive resource, giving Krystal Biotech the runway to advance its pipeline without immediate financing pressure. As of September 30, 2025, the balance sheet was robust, showing cash, cash equivalents, and investments totaling $864.2 million. This strong position is key to supporting global commercial launches and advancing the significant pipeline programs through the upcoming quarters.

Proprietary, in-house manufacturing capabilities for viral vectors

Controlling manufacturing is a critical operational resource, especially in gene therapy where supply chain reliance on external Contract Manufacturing Organizations (CMOs) can be a bottleneck. Krystal Biotech performs every stage of the manufacturing process in-house. This in-house capability, centered around their end-to-end Good Manufacturing Practice (GMP) facility, Ancoris, helps maintain control over process and production schedules. It also allows for streamlined scaling of manufacturing for their viral gene therapies.

Intellectual property surrounding the HSV-1-based gene therapy platform (STAR-D platform)

The intellectual property forms the technological moat around Krystal Biotech's core competency. The Skin TARgeted Delivery (STAR-D) platform is a proprietary, fully-integrated, HSV-1-based gene therapy platform. This IP covers the engineered viral vector and skin-optimized gene transfer technology. The platform's advantages are built into the IP, including:

• HSV-1's large genetic payload capacity, theoretical cargo capacity over 30 kb, significantly exceeding AAV's (<5 kb).
• The ability to deliver its genome episomally, avoiding insertion into the human genome.
• Engineering that potentially allows for safe repeated administration (re-dosing).
• A strong patent and IP portfolio protecting the STAR-D-based products and processes.

To further validate this key asset, the U.S. Food and Drug Administration (FDA) granted a platform technology designation to the HSV-1 viral vector in October 2025, recognizing its reproducibility and scalability.

Specialized commercial and medical affairs teams for rare disease markets

Bringing a rare disease therapy to market requires specialized human capital. Krystal Biotech has devoted significant resources to building out its commercial infrastructure to support VYJUVEK. This includes dedicated sales force, marketing, market access, and medical affairs teams. The company has actively worked to build the global Medical Affairs function, initially focused on supporting B-VEC for Dystrophic Epidermolysis Bullosa (DEB).

Finance: draft 13-week cash view by Friday.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Value Propositions

You're looking at the core differentiators Krystal Biotech, Inc. is putting forward to the market, and honestly, the numbers coming out of late 2025 are pretty compelling for their first product.

The primary value proposition centers on VYJUVEK, which is positioned as the first and only redosable, topical gene therapy for Dystrophic Epidermolysis Bullosa (DEB). This isn't just another treatment; it's designed to address the fundamental disease-causing mechanism. It works by delivering two copies of the COL7A1 gene directly to the DEB wounds, giving the patient's skin cells the template needed to make normal COL7 protein.

The convenience factor got a major boost in September 2025. The U.S. Food and Drug Administration (FDA) cleared a label update that significantly enhances patient life quality. Now, DEB patients and their caregivers have full flexibility regarding application and wound dressing management. This means patients or caregivers can apply VYJUVEK themselves at home, and dressings can be removed with the next scheduled change, rather than waiting a mandatory 24 hours. This shift to self-administration makes integrating the therapy into daily routines much easier, solidifying its role as a convenient, disease-modifying medicine.

Beyond the current commercial success, Krystal Biotech is banking on the platform's versatility. The company expects its underlying HSV-1 based gene delivery technology to prove its power across multiple tissues, which is a huge part of the long-term value story. They are actively pushing a broad pipeline targeting:

• Gene delivery in the lung for rare respiratory diseases, with candidates like KB407 and KB408.
• The eye, with a second clinical-stage ophthalmology program, KB801, for conditions like neurotrophic keratitis.
• The skin, with other dermatology candidates in preclinical development.

The operational efficiency supporting these value propositions is clear when you look at the margins. The manufacturing process appears highly effective, which is critical for scaling a complex gene therapy. Here's the quick math from their latest reported financials:

That 96% gross margin in Q3 2025, up from 93% the prior quarter, signals defintely efficient production and strong pricing power for VYJUVEK. Also, as of September 30, 2025, the balance sheet looks solid, with cash, cash equivalents, and investments totaling $864.2 million.

The market access side also supports the value proposition, showing that payers are buying in. As of Q3 2025, Krystal Biotech had secured over 615 reimbursement approvals for VYJUVEK in the United States.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Customer Relationships

You're launching a specialized, potentially curative therapy for a rare disease, so your customer relationship strategy has to be intensely personal and highly coordinated. For Krystal Biotech, Inc., this means building a comprehensive support structure around the patient, the provider, and the payer simultaneously. It's not just about selling a product; it's about enabling access and ensuring successful, long-term use of a complex gene therapy like VYJUVEK.

High-touch, specialized patient support programs for rare disease access and adherence

Krystal Biotech, Inc. uses its Krystal Connect™ program to deliver personalized patient support, which is critical given the at-home administration model for VYJUVEK. This high-touch service is designed to shepherd patients through the entire journey, from initial inquiry to routine treatment. A key metric showing this focus is the high rate of home administration; as of the third quarter of 2025, 97% of treatments in the United States were administered at home. This requires robust logistical support, which Krystal Biotech, Inc. facilitates through a partnership with Option Care Health® for in-home nursing and delivery coordination. Adherence is a constant focus in chronic or long-term treatment regimens. Patient compliance with the weekly VYJUVEK treatment while on drug was reported at 83% as of the end of the first quarter of 2025, slightly dipping to 82% by the end of the second quarter of 2025. The September 2025 FDA label update, which allows for patient or caregiver application at home, further emphasizes the need for this dedicated support structure.

The financial safety net provided by Krystal Biotech, Inc. is substantial for commercially insured patients. The VYJUVEK Copay Program has a maximum annual benefit paid by the company of $15,000 per calendar year, allowing eligible patients to pay as little as $0 per prescription up to that limit. For patients with limited or no insurance, the Patient Assistance Program (PAP) provides VYJUVEK at no cost based on qualifying financial need. Furthermore, the VYJUVEK Quick Start Program offers a temporary supply, up to a 12-week course, at no cost while the patient's insurance approval is being processed.

The patient support structure involves several key components:

• Personalized Patient Access Liaisons (PALs) guide the process.
• Disease education and resources on Dystrophic Epidermolysis Bullosa (DEB) are provided.
• Temporary medication supply via the Quick Start Program.
• Personalized support on cleansing and hydrophobic dressing application.

Direct engagement with key opinion leaders (KOLs) and rare disease patient advocacy groups

Engaging the rare disease community is foundational for a company like Krystal Biotech, Inc. The Krystal Connect program explicitly includes connecting patients to additional resources through advocacy groups. While specific numbers of KOLs engaged are not public, the company's global expansion strategy necessitates deep relationships with leading experts in DEB and other rare diseases to drive adoption and establish best practices for this novel gene therapy. The company is also advancing pipeline assets like KB407 for cystic fibrosis, which requires ongoing dialogue with CF Foundation Therapeutic Development Network sites.

Dedicated field sales and medical science liaison teams for healthcare providers

The commercial infrastructure is scaling up to support the global launch of VYJUVEK. In the United States, the investment in commercial infrastructure is reflected in the Selling, General, and Administrative (SG&A) expenses, which reached $32.7 million in the first quarter of 2025 and $37.6 million in the third quarter of 2025. For the European launch, which began in Germany in Q3 2025, commercial operations are supported by approximately 10 employees per country (Germany and France). In Japan, where VYJUVEK was approved in July 2025, the market strategy is supported by a team of 15 employees. These teams include field personnel responsible for educating healthcare providers (HCPs) on the administration and management of VYJUVEK.

Here's a look at the reported commercial team scaling:

Ongoing communication with payers to secure and maintain reimbursement coverage

Securing and maintaining payer coverage is a primary driver of revenue, as Krystal Biotech, Inc. notes that sales depend substantially on reimbursement availability. The company has made significant progress in the US market. As of February 2025, over 510 reimbursement approvals were secured. This number grew to over 540 by April 2025, and further to over 615 reimbursement approvals in the United States by the end of the third quarter of 2025. Furthermore, Krystal Biotech, Inc. maintained strong access nationwide, with positive access determinations for 97% of lives covered under commercial and Medicaid plans as of February 2025.

International payer discussions are in earlier stages. In Germany, the company has started discussions with payers, with pricing negotiations expected to continue until at least the second half of 2026. In France, early reimbursed access was secured under the post-marketing authorization Accès Précoce AP2 program. The European pricing strategy is conservative, aiming for 60-70% of US prices, varying by country.

The financial results show the success of this access strategy, with net product revenue reaching $88.2 million in Q1 2025, $96.0 million in Q2 2025, and $97.8 million in Q3 2025. The gross margin remained high, at 94% in Q1 2025 and 96% in Q3 2025, demonstrating that the cost of securing these relationships is not eroding the product's high value.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Channels

You're looking at how Krystal Biotech, Inc. gets its gene therapy, VYJUVEK, to the people who need it, especially now that they've moved from a purely US focus to a global commercial stage. It's a mix of direct control where they can manage it and partnerships where they can't.

The core US channel relies heavily on direct engagement with the specialized medical community. Krystal Biotech, Inc. deploys a direct sales force to reach the dermatologists and specialized Dystrophic Epidermolysis Bullosa (DEB) treatment centers across the country. As of May 2025, this commercial team consisted of 17 sales representatives covering all 52 states. This direct approach is supported by strong payer access, with the company having secured over 540 reimbursement approvals for VYJUVEK in the U.S. as of April 2025.

The administration method is a key part of this channel strategy. Krystal Biotech, Inc. has successfully structured the treatment process to be highly convenient for patients. Patient preference for at-home administration is extremely high, with 97% of treatments occurring in the home setting as of April 2025. This means the channel heavily involves the patient or caregiver administering the topical therapy after the initial in-office dosing.

The international expansion is being managed through direct commercial operations for the initial, most critical markets. The company executed its first European launch in Germany in late August 2025, with France being the other initial focus country. In Japan, the company is on track to launch before the end of 2025. For Germany, as of the third quarter of 2025, approximately 20 patients have been prescribed VYJUVEK across over 10 German centers.

For broader global market access beyond these initial direct launches, Krystal Biotech, Inc. is utilizing a specialty distributor network. This strategy helps manage the complexity of different regulatory and pricing environments outside the US, Germany, France, and Japan. The company has already executed agreements with regional specialty distributors covering key areas like the Middle East, Turkey, and Central and Eastern Europe. Distributor relationships are also being explored in regions like the Middle East and North Africa.

Here's a quick look at the geographic deployment across these channels:

The company's compliance metric is also important for channel health; patient compliance with the weekly on-drug treatment was 83% as of the end of Q1 2025.

The structure for international expansion looks like this:

• Direct commercial operations for initial European markets (Germany, France) and Japan.
• Building a specialty distributor network for the rest of the world.
• Executed agreements with regional specialty distributors covering the Middle East, Turkey, and Central and Eastern Europe.
• Exploring distributor relationships in the Middle East and North Africa.

Finance: Finance needs to track the expected revenue contribution from the Germany and France launches in Q4 2025 versus the full impact expected in early 2026.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Customer Segments

You're looking at the core patient and payer groups Krystal Biotech, Inc. (KRYS) targets with its gene therapy platform, primarily centered around the commercial success of VYJUVEK for Dystrophic Epidermolysis Bullosa (DEB).

Patients with Dystrophic Epidermolysis Bullosa (DEB), including newborns.

The initial and most critical segment is patients suffering from DEB. Krystal Biotech, Inc. estimates the U.S. DEB patient population to be roughly 3,000 individuals, though only 1,200 patients were identified at the time of the initial launch. Following a label update in September 2025, the eligible patient population was expanded by the U.S. Food and Drug Administration to include DEB patients from birth. The global addressable market is substantial, with management previously estimating around 9,000 DEB patients across reimbursable markets worldwide. Krystal Biotech, Inc. is actively expanding this segment through international launches; for instance, over 1,000 patients are estimated to reside in Germany and France combined.

Here's a quick look at the scope of the primary patient segment as of late 2025:

Specialized dermatologists and rare disease treatment centers globally.

Reaching these patients requires engagement with specialized prescribers and centers. The commercial execution involves a growing advocacy network and educational efforts to improve patient identification. For the international rollout, Krystal Biotech, Inc. is building out its infrastructure. Following the European Commission approval in April 2025, the company targeted its first European launch in Germany in mid-2025. By the third quarter of 2025, Krystal Biotech, Inc. estimated approximately 20 patients had been prescribed VYJUVEK across German centers, with over 10 German centers prescribing the therapy to date. The company also began hiring its field force in Japan in 2025 to support that market launch.

Key centers and prescribers are characterized by:

• U.S. centers supporting over 615 total VYJUVEK reimbursement approvals as of Q3 2025.
• High patient compliance with weekly treatment while on drug was reported at 82% as of the end of Q2 2025.
• The therapy is administered in a healthcare setting or at home, with the option for self-application by patients or caregivers following the September 2025 label update.

Healthcare payers (commercial and government) covering rare disease therapies.

Securing payer coverage is vital for access to these high-cost, transformative therapies. Krystal Biotech, Inc. has made significant progress in the U.S. market penetration. As of the third quarter of 2025, the company had secured over 615 reimbursement approvals for VYJUVEK in the United States. This access translates to positive coverage determinations for 97% of lives covered under commercial and Medicaid plans nationwide, a figure consistent across Q1, Q2, and Q3 2025 reports. For the international rollout, pricing negotiations in Germany were expected to continue until at least the second half of 2026.

Future segments: Cystic Fibrosis (CF) patients (KB407) and those with ocular DEB complications (KB803).

Krystal Biotech, Inc. is actively developing pipeline assets to address other serious and rare diseases, expanding its future customer base significantly. The CF patient population is large, with an estimated 105,000 people diagnosed across 94 countries. The KB407 program for CF is in a Phase 1 CORAL-1 study, which is evaluating ascending doses in adults with CF. The company expected an interim molecular data readout for Cohort 3 patients in Q4 2025, following earlier data expected mid-2025. The KB803 program targets DEB patients with ocular complications, with the Phase 3 IOLITE study anticipated to commence in the first half of 2025.

Key pipeline targets include:

• Cystic Fibrosis (KB407): Target population estimated at 105,000 globally.
• Ocular DEB (KB803): Targeting DEB patients with corneal abrasions; Phase 3 study start planned for 1H 2025.

Finance: draft 13-week cash view by Friday.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Krystal Biotech, Inc.'s operations as they scale commercialization and advance their pipeline. The cost structure is heavily weighted toward commercial expansion and R&D.

For the first nine months of 2025, Selling, General, and Administrative (SG&A) expenses totaled $105.3 million, inclusive of stock-based compensation of $33.1 million, driven by the commercial expansion efforts for VYJUVEK. Research and Development (R&D) expenses for the same nine-month period were $43.3 million, which supported the ongoing pipeline programs.

The Cost of Goods Sold (COGS) remains relatively low compared to the revenue generated. For the third quarter ending September 30, 2025, COGS was only $4.3 million. This resulted in a strong gross margin of 96% for Q3 2025, up from 93% the prior quarter, partly due to U.S. product manufacturing process optimizations.

Here's a breakdown of the key operating expenses through September 30, 2025:

The commercial focus also necessitates spending on infrastructure to support market reach. Krystal Biotech is incurring costs associated with global regulatory filings and building out the international launch infrastructure, as evidenced by the inclusion of early sales from the German launch in Q3 2025 net product revenue of $97.8 million.

The overall expense profile reflects a company in a growth phase, balancing commercial scale-up with pipeline advancement:

• Nine months ended September 30, 2025, Net Product Revenue was $282.0 million.
• Nine months ended September 30, 2025, total COGS was $16.5 million.
• Q3 2025 R&D expenses included $2.6 million in stock-based compensation.
• The company ended Q3 2025 with $864.2 million in combined cash, cash equivalents, and investments.

Finance: review the Q4 2025 projected spend against the revised FY 2025 Non-GAAP R&D and SG&A guidance of $145.0 - $155.0 million by next week.

Krystal Biotech, Inc. (KRYS) - Canvas Business Model: Revenue Streams

You're looking at the core engine driving Krystal Biotech, Inc.'s current financial performance, which is almost entirely centered on its first commercial product, VYJUVEK. As of late 2025, the revenue stream is dominated by net product sales of this topical gene therapy for Dystrophic Epidermolysis Bullosa (DEB).

The numbers for the year-to-date performance show strong uptake. Krystal Biotech, Inc. recorded net product revenue from sales of VYJUVEK, totaling $282.0 million for the nine months ended September 30, 2025. This represents significant growth over the $199.4 million in product revenue for the same nine-month period in 2024.

Looking closer at the most recent quarter, the company posted quarterly net product revenue of $97.8 million in Q3 2025. This was up sequentially from the $96.0 million recorded in Q2 2025. The gross margin on these sales for Q3 2025 was quite robust at 96%.

Here's a quick look at how the revenue has built up through the first three quarters of 2025:

This revenue growth is clearly being driven by two main factors: deep US market penetration and the start of international expansion. You can see the US momentum with over 615 reimbursement approvals secured as of September 30, 2025. The label update in September 2025, allowing for home application by patients or caregivers, should help sustain this US adoption curve.

The international push is just beginning to contribute to the top line. Krystal Biotech, Inc. launched VYJUVEK in Germany in late August 2025, marking its first commercial launch outside the United States. Furthermore, the company has initiated commercial operations in France and Japan in Q4 2025. To give you a sense of early international traction, the estimated number of patients prescribed VYJUVEK in Germany was approximately 20 based on early aggregate level data reported in November 2025. Analysts had projected full-year 2025 sales around $390.3 million, with the Q4 2025 consensus estimate sitting at $107.2 million, which will incorporate these new international sales.

Beyond the immediate product sales, the revenue model has future upside tied to the pipeline. This includes potential milestone and royalty payments from pipeline candidates or partnerships. Krystal Biotech, Inc. is advancing several programs, such as KB407 for cystic fibrosis (CF) and KB803 for ocular applications, with key clinical readouts anticipated before the end of 2025. Success in these areas, especially with the FDA granting platform technology designation to its HSV-1 gene delivery platform, could unlock further value through future licensing or collaboration agreements, adding a layer of optionality to the revenue structure.

The key revenue drivers you should watch are:

• Sustained US patient adoption and reimbursement expansion.
• The ramp-up speed of initial sales in Germany, France, and Japan.
• The timing and size of any upfront payments or milestones from pipeline collaborations.

Finance: draft 13-week cash view by Friday.