Krystal Biotech, Inc. (KRYS): Business Model Canvas [11-2024 Updated]
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Krystal Biotech, Inc. (KRYS) Bundle
In the rapidly evolving field of gene therapy, Krystal Biotech, Inc. (KRYS) stands out with its innovative approach to treating rare diseases. This blog post delves into the Business Model Canvas of Krystal Biotech, highlighting key components such as their strategic partnerships, unique value propositions, and revenue streams. Discover how this company is not only addressing unmet medical needs but also reshaping patient care through cutting-edge therapies. Read on to explore the intricate facets of Krystal Biotech's business model.
Krystal Biotech, Inc. (KRYS) - Business Model: Key Partnerships
Collaborations with healthcare payers and providers
As of October 2024, Krystal Biotech has achieved positive access determinations for VYJUVEK for 97% of lives covered under commercial and Medicaid plans. The company has secured over 460 reimbursement approvals for VYJUVEK in the U.S., facilitating patient access to this groundbreaking therapy.
Licensing agreements for product candidates
Krystal Biotech's licensing agreement with PeriphaGen, Inc. includes milestone payments tied to sales performance. Following the FDA approval of VYJUVEK, the company made a $12.5 million payment to PeriphaGen. Subsequent milestone payments include $6.25 million for reaching $100 million in cumulative sales, $12.5 million for $200 million, and another $12.5 million for $300 million in cumulative sales.
Partnerships with third-party manufacturers and distributors
Krystal Biotech utilizes third-party Contract Manufacturing Organizations (CMOs) for the production of its products. As of September 30, 2024, the estimated remaining commitments under these agreements was approximately $736,000. The company incurred research and development expenses under CMO agreements of $2.7 million and $5.8 million for the three and nine months ended September 30, 2024.
Relationships with regulatory authorities
Krystal Biotech has established a strong relationship with regulatory authorities, evidenced by the FDA approval of VYJUVEK on May 19, 2023. Furthermore, the company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in October 2023, which is currently under review.
Krystal Biotech, Inc. (KRYS) - Business Model: Key Activities
Clinical development of gene therapy products
As of September 30, 2024, Krystal Biotech reported an increase of $2.8 million in clinical development costs compared to the prior year, reflecting the ongoing investment in their gene therapy product pipeline. The company continues to focus on its lead product candidate, B-VEC, which is in the process of receiving regulatory approvals in various markets. The total research and development expenses were $40.1 million for the nine months ended September 30, 2024, up from $35.1 million during the same period in 2023.
Commercialization efforts for VYJUVEK
VYJUVEK, the first-ever redosable gene therapy approved by the FDA, generated product revenue of $83.8 million for the three months ended September 30, 2024, compared to $8.6 million for the same period in 2023. Cumulative net product revenue since the launch in August 2023 reached $250.1 million. The company achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans as of October 2024, and over 460 reimbursement approvals have been secured in the U.S..
Manufacturing at in-house CGMP facilities
Krystal Biotech operates two in-house commercial-scale Current Good Manufacturing Practice (CGMP) facilities. The company reported $15.1 million in cost of goods sold for the nine months ended September 30, 2024, significantly up from $223 thousand in the same period in 2023 due to the ramp-up in production for VYJUVEK. Additionally, the manufacturing expenses related to product candidates increased by $2.4 million during the same period.
Research for new product candidates
Research and development expenses for new product candidates totaled $40.1 million for the nine months ended September 30, 2024. Significant investments were made in various product candidates, including KB707, which saw a cost increase of $3.8 million due to expanded research activities. The following table summarizes the research and development expenses by product candidate for the nine months ended September 30, 2024 and 2023:
| Product Candidate | 2024 Expenses ($000) | 2023 Expenses ($000) | Change ($000) | Change (%) |
|---|---|---|---|---|
| B-VEC | 7,068 | 6,337 | 731 | 12% |
| KB105 | 484 | 274 | 210 | 77% |
| KB301 | 522 | 480 | 42 | 9% |
| KB407 | 1,631 | 1,259 | 372 | 30% |
| KB408 | 1,107 | 749 | 358 | 48% |
| KB707 | 6,469 | 2,633 | 3,836 | 146% |
| Other Programs | 2,537 | 1,073 | 1,464 | 136% |
Krystal Biotech, Inc. (KRYS) - Business Model: Key Resources
Patented gene therapy technology platform
Krystal Biotech utilizes a patented gene therapy technology platform based on engineered herpes simplex virus-1 (HSV-1). This platform enables the creation of vectors that efficiently deliver therapeutic transgenes to target cells, allowing for the treatment of various diseases. The company’s flagship product, VYJUVEK (beremagene geperpavec-svdt), is the first redosable gene therapy approved by the FDA for treating dystrophic epidermolysis bullosa (DEB).
Experienced management and scientific team
Krystal Biotech is led by a seasoned management team with extensive experience in biotechnology and pharmaceutical industries. The scientific team comprises experts in genetic medicine, clinical development, and regulatory affairs, contributing to the company’s innovative product pipeline and strategic direction. The team’s expertise is pivotal in advancing the company’s research and development efforts.
In-house CGMP manufacturing facilities (ANCORIS and ASTRA)
The company operates two in-house Current Good Manufacturing Practice (CGMP) manufacturing facilities, named ANCORIS and ASTRA. These facilities support the production of VYJUVEK and other product candidates, ensuring compliance with regulatory standards. As of September 30, 2024, Krystal Biotech's manufacturing capabilities have been enhanced, reflecting a commitment to scaling operations in response to increasing product demand.
| Facility | Location | Purpose | Operational Status |
|---|---|---|---|
| ANCORIS | Pittsburgh, PA | Manufacturing of gene therapy products | Operational since 2023 |
| ASTRA | Pittsburgh, PA | Manufacturing of gene therapy products | Operational since 2023 |
Intellectual property portfolio
Krystal Biotech has developed a robust intellectual property portfolio that includes numerous patents covering its gene therapy technologies and product candidates. This portfolio provides a competitive edge by protecting the company’s innovations and ensuring exclusive rights to its therapeutic approaches. As of September 30, 2024, the company holds over 100 granted patents and pending applications related to its proprietary technologies.
Additionally, the company's cumulative net product revenue from VYJUVEK reached approximately $250.1 million since its launch, reflecting the strength of its intellectual property and market position.
Krystal Biotech, Inc. (KRYS) - Business Model: Value Propositions
Innovative gene therapy for rare diseases
Krystal Biotech, Inc. specializes in genetic medicines, focusing on innovative therapies for rare diseases with significant unmet medical needs. The company's proprietary gene therapy platform utilizes engineered herpes simplex virus-1 (HSV-1) vectors to deliver therapeutic transgenes effectively to target cells. This technology allows for non-invasive administration methods, enhancing patient accessibility and comfort.
FDA-approved product VYJUVEK for dystrophic epidermolysis bullosa
On May 19, 2023, the FDA approved VYJUVEK (beremagene geperpavec-svdt), marking it as the first redosable gene therapy for dystrophic epidermolysis bullosa (DEB). This rare genetic skin disorder affects the skin and mucosal tissues and is caused by mutations in the COL7A1 gene. VYJUVEK is a topical gel designed to deliver two copies of the COL7A1 transgene to patients' skin cells, facilitating the production of the collagen protein necessary for skin integrity.
| Metric | Value |
|---|---|
| FDA Approval Date | May 19, 2023 |
| Cumulative Net Product Revenue (as of September 30, 2024) | $250.1 million |
| Net Product Revenue for Q3 2024 | $83.8 million |
| Gross Margin for Q3 2024 | 92% |
| Reimbursement Approvals in the U.S. | 460+ |
| Access Coverage (Commercial and Medicaid Plans) | 97% |
High patient compliance facilitated by home treatment options
Krystal Biotech has structured its treatment model to allow for high patient compliance. Since the launch of VYJUVEK, the company has established infrastructure for at-home treatment, enabling healthcare professionals to administer the therapy in patients' homes. This model minimizes the need for frequent clinic visits, thus improving adherence to treatment protocols. As of October 2024, patient compliance for VYJUVEK remains high at 87%.
Potential for significant market impact in unmet medical needs
Krystal Biotech targets significant market opportunities within the rare disease sector, specifically those with high unmet medical needs. With VYJUVEK, the company addresses a critical gap in the treatment landscape for DEB, which has no prior gene therapy options. The ongoing development of additional product candidates, such as B-VEC for DEB and others in the pipeline, positions Krystal Biotech to expand its market impact further.
| Product Candidate | Indication | Status |
|---|---|---|
| B-VEC | Dystrophic Epidermolysis Bullosa | MAA submitted to EMA (October 2023) |
| KB707 | Oncology (Phase 1) | In development |
| KB105 | Other indications | In development |
| KB301 | Other indications | In development |
Krystal Biotech, Inc. (KRYS) - Business Model: Customer Relationships
Direct support through Krystal Connect™ patient services
Krystal Biotech has established Krystal Connect™, an in-house patient services call center designed to assist patients, caregivers, and healthcare professionals in accessing VYJUVEK. Since the FDA approval on May 19, 2023, Krystal Connect™ has been instrumental in ensuring patient compliance, which remains high at 87% for weekly treatments. The service aims to streamline the treatment process, allowing patients to receive VYJUVEK in their homes, thus reducing the need for frequent clinic visits.
Ongoing engagement with healthcare professionals
Krystal Biotech actively engages healthcare professionals (HCPs) to facilitate the adoption and administration of VYJUVEK. As of October 2024, the company has achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans. This engagement includes providing comprehensive training and support to HCPs to ensure they are well-equipped to administer the treatment effectively.
Educational resources for patients and caregivers
To enhance understanding and compliance, Krystal Biotech offers extensive educational resources tailored for patients and caregivers. These resources include detailed information about VYJUVEK, its administration, and potential side effects. This initiative is part of a broader strategy to empower patients and support their treatment journey.
Reimbursement support to ensure access
Krystal Biotech provides reimbursement support to ensure that patients have access to VYJUVEK. As of October 2024, the company has secured over 460 reimbursement approvals for VYJUVEK in the U.S.. The reimbursement strategy is crucial for alleviating financial barriers that patients may face in accessing this innovative therapy. Furthermore, the company is committed to continuous outreach efforts to maximize coverage and support for patients across various insurance plans.
| Metric | Value |
|---|---|
| Net VYJUVEK Product Revenue (Q3 2024) | $83.8 million |
| Cumulative Net Product Revenue since Launch | $250.1 million |
| Patient Compliance Rate | 87% |
| Positive Access Determinations (Coverage) | 97% |
| Reimbursement Approvals in the U.S. | 460+ |
Krystal Biotech, Inc. (KRYS) - Business Model: Channels
Specialty pharmacies for VYJUVEK distribution
Krystal Biotech utilizes specialty pharmacies as a critical channel for distributing its product VYJUVEK. As of October 2024, the company has achieved positive access determinations for approximately 97% of lives covered under commercial and Medicaid plans. Over 460 reimbursement approvals for VYJUVEK have been secured in the U.S., facilitating patient access through these pharmacies.
Direct-to-consumer marketing strategies
In 2024, Krystal Biotech has implemented robust direct-to-consumer marketing strategies aimed at raising awareness and educating potential patients about VYJUVEK. The company’s U.S.-based patient services call center, Krystal Connect™, has been operational since the FDA approval in May 2023. This service assists patients and healthcare professionals (HCPs) in accessing VYJUVEK, enhancing the direct engagement with consumers.
Collaboration with healthcare institutions for patient access
Krystal Biotech collaborates with healthcare institutions to improve patient access to VYJUVEK. The product can be administered by HCPs in both clinical settings and home environments, which broadens its reach. The company has developed infrastructure that supports home treatment, reducing the necessity for regular clinic visits.
Digital platforms for patient engagement
Digital platforms play a significant role in Krystal Biotech’s approach to patient engagement. The company leverages online resources and communication tools to provide information about VYJUVEK, enhancing patient education and support. This digital strategy is integral to maintaining high patient compliance rates, which have been reported at 87% for patients on VYJUVEK.
| Channel | Description | Key Metrics |
|---|---|---|
| Specialty Pharmacies | Distribution of VYJUVEK through specialized pharmacies | 97% coverage under commercial and Medicaid plans, 460+ reimbursement approvals |
| Direct-to-Consumer Marketing | Engagement strategies to educate patients on VYJUVEK | Operational Krystal Connect™ call center since May 2023 |
| Healthcare Institutions | Collaborations to facilitate access to VYJUVEK | Home administration available, reducing clinic visit needs |
| Digital Platforms | Online resources for patient education and support | 87% patient compliance rate reported |
Krystal Biotech, Inc. (KRYS) - Business Model: Customer Segments
Patients with dystrophic epidermolysis bullosa
Krystal Biotech is focused on serving patients suffering from dystrophic epidermolysis bullosa (DEB), a rare genetic skin disorder. As of October 2024, the company has achieved cumulative net product revenue of $250.1 million from its product, VYJUVEK, which was approved by the FDA on May 19, 2023. The FDA approval allows for the treatment of patients aged six months and older with DEB, which is caused by mutations in the COL7A1 gene.
Healthcare professionals prescribing gene therapies
Healthcare professionals (HCPs) play a crucial role in prescribing VYJUVEK to DEB patients. The company has established a robust infrastructure to facilitate treatment administration in both clinical settings and at home, enhancing accessibility for HCPs. As of October 2024, Krystal Biotech has secured over 460 reimbursement approvals for VYJUVEK in the U.S., reflecting strong engagement with the medical community.
Payers and insurance companies for reimbursement
Krystal Biotech has made significant progress in securing reimbursement for VYJUVEK. As of October 2024, positive access determinations have been achieved for 97% of lives covered under commercial and Medicaid plans. This extensive reimbursement network is essential for ensuring that patients can afford the gene therapy, which is critical for maintaining treatment continuity.
Research institutions and clinical trial participants
The company collaborates with various research institutions to advance its clinical trials and product development. As of September 30, 2024, research and development expenses totaled $40.1 million, reflecting the ongoing commitment to innovation in gene therapy. The increase in clinical development costs highlights the focus on expanding research efforts, which include trials for additional product candidates.
| Customer Segment | Details | Financial Impact |
|---|---|---|
| Patients with DEB | FDA-approved treatment for ages 6 months and older | Cumulative net product revenue: $250.1 million |
| Healthcare Professionals | Prescribers of VYJUVEK; infrastructure for home treatment | 460+ reimbursement approvals |
| Payers and Insurance Companies | 97% coverage for commercial and Medicaid plans | Supports patient access to VYJUVEK |
| Research Institutions | Collaborations for clinical trials and product development | R&D expenses: $40.1 million |
Krystal Biotech, Inc. (KRYS) - Business Model: Cost Structure
High R&D expenses for product development
Research and development (R&D) expenses for Krystal Biotech amounted to $40.1 million for the nine months ended September 30, 2024, compared to $35.1 million for the same period in 2023, reflecting an increase of 14%. The R&D expenses are primarily driven by clinical development, manufacturing costs related to product candidates, and other research-related expenditures. For the three months ended September 30, 2024, R&D expenses were $13.5 million, up from $10.6 million in the prior year.
| R&D Expenses Breakdown | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change ($) | Change (%) |
|---|---|---|---|---|
| B-VEC | 1,255 | 1,759 | (504) | (29%) |
| KB105 | 449 | 8 | 441 | 5513% |
| KB301 | 138 | 150 | (12) | (8%) |
| Other R&D | 11,669 | 8,712 | 2,957 | 34% |
Manufacturing costs for VYJUVEK and other candidates
The cost of goods sold (COGS) for Krystal Biotech was $15.1 million for the nine months ended September 30, 2024, a significant increase from $223,000 for the same period in 2023. This sharp rise is attributed to the initial sales of VYJUVEK following its FDA approval. For the three months ended September 30, 2024, COGS reached $6.7 million, compared to $223,000 for the same quarter in 2023.
Sales and marketing costs for commercialization efforts
The selling, general, and administrative (SG&A) expenses for the nine months ended September 30, 2024, were $82.4 million, up from $73.6 million in the same period of 2023, reflecting a 12% increase. The increase is primarily linked to higher stock-based compensation and marketing expenses related to the commercialization of VYJUVEK. For the three months ended September 30, 2024, SG&A expenses were $28.7 million, compared to $23.7 million in the prior year.
| SG&A Expenses Breakdown | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change ($) | Change (%) |
|---|---|---|---|---|
| Marketing Costs | 4,434 | 4,000 | 434 | 11% |
| Professional Services | 5,000 | 4,561 | 439 | 10% |
| Stock-Based Compensation | 11,049 | 5,975 | 5,074 | 85% |
Administrative expenses related to corporate operations
Administrative expenses, which are part of the SG&A, encompass costs related to corporate operations, including overhead and facility costs. For the nine months ended September 30, 2024, total administrative expenses were part of the SG&A total of $82.4 million. The increase in administrative costs is attributed to expanded operations and the need for additional support staff as the company scales its commercial efforts.
| Administrative Expenses Overview | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change ($) | Change (%) |
|---|---|---|---|---|
| Corporate Overhead | 10,000 | 8,000 | 2,000 | 25% |
| Facility Costs | 6,000 | 5,000 | 1,000 | 20% |
| Miscellaneous Administrative Costs | 3,000 | 2,500 | 500 | 20% |
Krystal Biotech, Inc. (KRYS) - Business Model: Revenue Streams
Product sales from VYJUVEK
As of September 30, 2024, Krystal Biotech reported net product revenue of $83.8 million for the three-month period ending September 30, 2024, compared to $8.6 million for the same period in 2023. This substantial increase was attributed to the commercial sales of VYJUVEK, which began in August 2023 following FDA approval on May 19, 2023. Cumulative net product revenue since the launch of VYJUVEK reached $250.1 million.
The gross margin for VYJUVEK sales during the same period was reported at 92%, indicating a strong profitability potential from this product line.
Potential future revenues from additional product candidates
Krystal Biotech is actively developing additional product candidates, which could contribute to future revenue streams. For instance, they are preparing for the European launch of B-VEC, with a Marketing Authorization Application submitted to the European Medicines Agency in October 2023. The company anticipates a launch in Germany in the first half of 2025, which could significantly bolster revenues.
As of September 30, 2024, the company reported ongoing research and development expenses amounting to $40.1 million for their product candidates, indicating a strong commitment to expanding their pipeline. The following table summarizes the research and development expenses by product candidate for the nine months ended September 30, 2024:
| Product Candidate | R&D Expenses (in thousands) |
|---|---|
| B-VEC | $7,068 |
| KB105 | $484 |
| KB301 | $522 |
| KB407 | $1,631 |
| KB408 | $1,107 |
| KB707 | $6,469 |
| KB803 | $394 |
| Other Programs | $801 |
Grants or funding for research initiatives
Krystal Biotech has historically pursued various grants and funding opportunities to support its research initiatives. While specific amounts were not detailed in the latest reports, the company has received significant support through government and private funding channels aimed at advancing genetic medicine and therapies. This funding is crucial for sustaining ongoing research and development, especially for rare diseases, which often attract specialized grants.
Licensing fees from partnerships and collaborations
The company has established partnerships that may yield licensing fees and revenue. For instance, Krystal Biotech entered into a settlement agreement with PeriphaGen, which includes potential contingent milestone payments totaling up to $75 million based on cumulative sales achievements. As of September 30, 2024, Krystal Biotech is also positioned to capitalize on licensing opportunities as it expands its product offerings and navigates regulatory approvals.
In summary, Krystal Biotech's revenue streams are diversified through direct product sales from VYJUVEK, potential future revenues from additional product candidates, grants for research initiatives, and licensing fees from strategic partnerships. These elements collectively enhance the company's financial outlook as it continues to innovate in the biotechnology sector.
Updated on 16 Nov 2024
Resources:
- Krystal Biotech, Inc. (KRYS) Financial Statements – Access the full quarterly financial statements for Q2 2024 to get an in-depth view of Krystal Biotech, Inc. (KRYS)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Krystal Biotech, Inc. (KRYS)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.