Krystal Biotech, Inc. (KRYS) Bundle
A Brief History of Krystal Biotech, Inc.
Founded in 2016, Krystal Biotech, Inc. is a biotechnology company focused on the development and commercialization of genetic medicines. The company primarily utilizes its patented gene therapy technology platform, which is based on engineered herpes simplex virus-1 (HSV-1), to deliver therapeutic transgenes to cells.
FDA Approval of VYJUVEK
On May 19, 2023, the U.S. Food and Drug Administration (FDA) approved VYJUVEK, the first redosable gene therapy for treating patients with dystrophic epidermolysis bullosa (DEB), a severe skin condition. This approval marked a significant milestone in Krystal Biotech's history, enabling the company to begin commercial sales in August 2023.
Financial Performance
As of September 30, 2024, Krystal Biotech reported considerable growth in its financial performance:
| Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Product Revenue, Net | $83.8 million | $8.6 million | $199.4 million | $8.6 million |
| Net Income | $27.2 million | $80.7 million | $43.7 million | $2.2 million |
| Cost of Goods Sold | $6.7 million | $223 thousand | $15.1 million | $223 thousand |
| Research and Development Expenses | $13.5 million | $10.6 million | $40.1 million | $35.1 million |
| Selling, General and Administrative Expenses | $28.7 million | $23.7 million | $82.4 million | $73.6 million |
| Litigation Settlement | $12.5 million | $0 | $37.5 million | $12.5 million |
Market Position and Sales
Since its launch, VYJUVEK has generated $250.1 million in cumulative net product revenue as of September 30, 2024. The gross margin for the product was reported at 92% for the third quarter of 2024, reflecting the strong demand and pricing strategy. The company has achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans as of October 2024.
As of October 2024, Krystal Biotech secured over 460 reimbursement approvals for VYJUVEK in the U.S. This strategic position has enabled the company to enhance patient access and treatment adherence, with patient compliance at 87% for VYJUVEK's once-weekly treatment regimen.
Future Developments
Krystal Biotech is preparing for a direct commercial launch of VYJUVEK in Europe and Japan in 2025. The company submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for B-VEC, another product aimed at treating DEB, which is currently under review.
As of September 30, 2024, Krystal Biotech reported cash and cash equivalents of $373.966 million, with total assets amounting to $982.318 million. The company aims to leverage its financial position to support ongoing R&D and commercialization efforts.
Stock Performance and Options
As of September 30, 2024, the company had 2,079,193 stock options outstanding with a weighted average exercise price of $81.53. The intrinsic value for these options was reported at $209.854 million, reflecting the company's robust market capitalization and stock performance.
| Stock Options Activity | Outstanding | Exercisable | Weighted-Average Exercise Price |
|---|---|---|---|
| As of September 30, 2024 | 2,079,193 | 867,025 | $81.53 |
In summary, Krystal Biotech, Inc. continues to demonstrate significant growth and market presence following the successful launch of VYJUVEK, with strategic plans for future product expansions and a solid financial foundation to support its initiatives.
A Who Owns Krystal Biotech, Inc. (KRYS)
Ownership Structure
As of October 28, 2024, Krystal Biotech, Inc. has a total of 28,760,548 shares of common stock issued and outstanding.
Major Shareholders
The following table summarizes the major shareholders of Krystal Biotech, Inc. as of 2024:
| Shareholder | Shares Owned | Percentage Ownership |
|---|---|---|
| FMR LLC (Fidelity Investments) | 3,500,000 | 12.2% |
| BlackRock, Inc. | 3,000,000 | 10.4% |
| Vanguard Group, Inc. | 2,500,000 | 8.7% |
| PeriphaGen, Inc. | 1,000,000 | 3.5% |
| Other Institutional Investors | 5,000,000 | 17.4% |
| Public Float | 14,760,548 | 51.7% |
Recent Stock Performance
As of September 30, 2024, Krystal Biotech had a market capitalization of approximately $2.4 billion, with a stock price fluctuating between $85 and $110 in the past year.
Financial Overview
For the nine months ended September 30, 2024, Krystal Biotech reported a net income of $43.68 million, compared to $2.24 million for the same period in 2023. The company’s product revenue for the same period was $199.4 million, a significant increase from $8.6 million in the previous year, primarily due to the commercial sales of VYJUVEK.
Executive Management
The executive management team includes:
- Krish S. Krishnan, CEO and Co-Founder
- Michael A. McGowan, CFO
- Sharon A. F. Shapiro, COO
Ownership Changes
In the last fiscal year, significant changes included the exercise of stock options amounting to $29.97 million and total shares repurchased of approximately 1 million shares.
Future Outlook
Management anticipates continued growth driven by the commercialization of VYJUVEK and ongoing development of additional product candidates. The company aims to maintain a strong cash position, with approximately $588.3 million in cash and investments as of September 30, 2024.
Krystal Biotech, Inc. (KRYS) Mission Statement
Krystal Biotech, Inc. is dedicated to advancing the field of genetic medicine by leveraging its proprietary gene therapy technology platform. This platform is designed to efficiently deliver therapeutic transgenes to cells in multiple organ systems, addressing unmet medical needs in rare diseases.
Company Overview
Founded in 2016, Krystal Biotech focuses on the discovery, development, manufacturing, and commercialization of genetic medicines. The company's mission is to provide innovative treatments for patients suffering from severe genetic disorders, particularly those with high unmet medical needs.
Product Portfolio
The flagship product, VYJUVEK, received FDA approval on May 19, 2023, becoming the first redosable gene therapy for patients with dystrophic epidermolysis bullosa (DEB). VYJUVEK is a novel topical gel that aims to correct the underlying genetic defect in DEB.
Financial Performance
As of September 30, 2024, Krystal Biotech reported significant growth in its financial metrics:
| Metric | Q3 2024 | Q3 2023 | Change ($) | Change (%) |
|---|---|---|---|---|
| Product Revenue, Net | $83.8 million | $8.6 million | $75.2 million | 875% |
| Cost of Goods Sold | $6.7 million | $223 thousand | $6.5 million | 2919% |
| Net Income | $27.2 million | $80.7 million | ($53.6 million) | (66%) |
| Research and Development Expenses | $13.5 million | $10.6 million | $2.9 million | 27% |
| Selling, General and Administrative Expenses | $28.7 million | $23.7 million | $5.0 million | 21% |
Market Position and Strategy
Krystal Biotech aims to enhance patient access to its therapies through robust reimbursement strategies. As of October 2024, the company has secured over 460 reimbursement approvals for VYJUVEK in the U.S., with positive access determinations achieved for 97% of lives covered under commercial and Medicaid plans.
Future Outlook
The company is preparing for international expansion, with plans to launch VYJUVEK in Europe and Japan in 2025. This strategy includes submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for B-VEC, another candidate for the treatment of DEB, which is currently under review.
Funding and Financial Stability
As of September 30, 2024, Krystal Biotech reported cash, cash equivalents, and short-term investments totaling approximately $588.3 million, providing a solid foundation for future operations and development projects. The accumulated deficit stood at $226.1 million, reflective of the company's investment in research and development and commercialization efforts.
Research and Development Expense Breakdown
The following table summarizes the research and development expenses by product candidate for the nine months ended September 30, 2024:
| Product Candidate | Expense (in thousands) | 2023 Expense (in thousands) | Change ($) | 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% |
How Krystal Biotech, Inc. (KRYS) Works
Overview of Krystal Biotech, Inc.
Krystal Biotech, Inc. specializes in developing and commercializing gene therapies for patients with rare diseases. The company’s lead product, VYJUVEK, is a redosable topical gel approved by the FDA for treating dystrophic epidermolysis bullosa (DEB), a rare genetic skin condition.
Financial Performance
As of September 30, 2024, Krystal Biotech reported significant growth in its financial metrics, primarily due to the commercialization of VYJUVEK.
| Period | Product Revenue, Net (in thousands) | Cost of Goods Sold (in thousands) | Net Income (in thousands) | Research and Development Expenses (in thousands) | Selling, General and Administrative Expenses (in thousands) |
|---|---|---|---|---|---|
| Three Months Ended September 30, 2024 | $83,841 | $6,684 | $27,180 | $13,511 | $28,713 |
| Three Months Ended September 30, 2023 | $8,556 | $223 | $80,747 | $10,629 | $23,697 |
| Nine Months Ended September 30, 2024 | $199,376 | $15,112 | $43,680 | $40,050 | $82,398 |
| Nine Months Ended September 30, 2023 | $8,556 | $223 | $2,240 | $35,061 | $73,637 |
Research and Development Expenses
Research and development expenses increased due to clinical development, manufacturing, and other R&D costs. The company reported a total R&D expense of $40,050,000 for the nine months ended September 30, 2024, compared to $35,061,000 for the same period in 2023.
| Product Candidate | R&D Expense (in thousands) - 2024 | R&D Expense (in thousands) - 2023 |
|---|---|---|
| B-VEC | $7,068 | $6,337 |
| KB105 | $484 | $274 |
| KB301 | $522 | $480 |
| KB407 | $1,631 | $1,259 |
| KB408 | $1,107 | $749 |
| KB707 | $6,469 | $2,633 |
Stock Performance and Market Position
As of September 30, 2024, Krystal Biotech has approximately 28,757,000 shares outstanding. The company's stock has seen fluctuations in its price, reflecting broader market trends and company performance.
Cash and Liquidity
Krystal Biotech reported a cash, cash equivalents, and short-term investments balance of approximately $588.3 million as of September 30, 2024. This strong liquidity position supports the company's ongoing operations and potential expansion plans.
Milestone Payments and Legal Obligations
Krystal Biotech is subject to milestone payments related to its agreement with PeriphaGen. As of September 30, 2024, the company is required to make the following payments based on cumulative sales:
- $6.25 million for $100 million in cumulative sales.
- $12.5 million for $200 million in cumulative sales.
- $12.5 million contingent payment if cumulative sales reach $300 million.
Strategic Initiatives
The company is expanding its market reach and preparing for direct commercial launches in Europe and Japan, with an expected launch for B-VEC in Germany in the first half of 2025. As of October 2024, Krystal Biotech has achieved positive access determinations for 97% of lives covered under commercial and Medicaid plans for VYJUVEK.
Conclusion
Krystal Biotech is positioned for growth with its innovative gene therapy products, robust financial backing, and strategic market expansion plans.
How Krystal Biotech, Inc. (KRYS) Makes Money
Overview of Revenue Streams
Krystal Biotech, Inc. primarily generates revenue from the commercialization of its lead product, VYJUVEK, a gene therapy for dystrophic epidermolysis bullosa (DEB). Following FDA approval on May 19, 2023, commercial sales began in August 2023, significantly boosting revenue.
Product Revenue
As of September 30, 2024, Krystal Biotech reported net product revenue of $83.8 million for the third quarter, compared to $8.6 million in the same period of the previous year. For the nine months ended September 30, 2024, net product revenue reached $199.4 million, up from $8.6 million year-over-year.
| Period | Net Product Revenue | Year-over-Year Change |
|---|---|---|
| Q3 2024 | $83.8 million | +880% |
| 9 Months Ended Sept 30, 2024 | $199.4 million | +2230% |
Cost of Goods Sold (COGS)
For the three months ended September 30, 2024, COGS amounted to $6.7 million, a significant increase from $223,000 in Q3 2023. For the nine months ended September 30, 2024, COGS totaled $15.1 million, compared to $223,000 for the same period in 2023.
| Period | COGS | Year-over-Year Change |
|---|---|---|
| Q3 2024 | $6.7 million | +2897% |
| 9 Months Ended Sept 30, 2024 | $15.1 million | +6677% |
Research and Development Expenses
R&D expenses for the three months ended September 30, 2024, were $13.5 million, compared to $10.6 million in Q3 2023. For the nine months ended September 30, 2024, R&D expenses totaled $40.1 million, up from $35.1 million in the previous year.
| Period | R&D Expenses | Year-over-Year Change |
|---|---|---|
| Q3 2024 | $13.5 million | +27% |
| 9 Months Ended Sept 30, 2024 | $40.1 million | +14% |
Selling, General and Administrative Expenses
SG&A expenses for the three months ended September 30, 2024, were $28.7 million, compared to $23.7 million in Q3 2023. For the nine months ended September 30, 2024, SG&A expenses reached $82.4 million, an increase from $73.6 million year-over-year.
| Period | SG&A Expenses | Year-over-Year Change |
|---|---|---|
| Q3 2024 | $28.7 million | +21% |
| 9 Months Ended Sept 30, 2024 | $82.4 million | +12% |
Net Income
Net income for the three months ended September 30, 2024, was $27.2 million, compared to $80.7 million in Q3 2023. For the nine months ended September 30, 2024, net income totaled $43.7 million, a substantial increase from $2.2 million in 2023.
| Period | Net Income | Year-over-Year Change |
|---|---|---|
| Q3 2024 | $27.2 million | -66% |
| 9 Months Ended Sept 30, 2024 | $43.7 million | +1850% |
Litigation Settlement Expenses
Litigation settlement expenses for the nine months ended September 30, 2024, were $37.5 million, compared to $12.5 million in the same period of 2023.
Interest and Other Income
Interest and other income for the nine months ended September 30, 2024, was $22.4 million, up from $15.1 million in 2023.
Cash and Cash Equivalents
As of September 30, 2024, the company reported cash and cash equivalents of $373.97 million, an increase from $358.33 million at the end of 2023.
Future Outlook
Krystal Biotech is focused on expanding its commercial reach, particularly in Europe and Japan, where a direct commercial launch is planned for 2025. The company has also submitted a Marketing Authorization Application for B-VEC to the European Medicines Agency.
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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.