Iovance Biotherapeutics, Inc. (IOVA) Bundle
A Brief History of Iovance Biotherapeutics
Company Overview
Iovance Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on cell therapy for cancer treatment. As of 2024, the company has launched its first product, Amtagvi™, and acquired the worldwide rights to Proleukin®.
Recent Financial Performance
For the three months ended September 30, 2024, Iovance reported total net revenue of $58.6 million, a significant increase from $469,000 in the same period in 2023. This represents a growth of 12,385%. For the nine months ended September 30, 2024, total revenue was $90.4 million, up from $707,000 in 2023, marking a growth of 12,683%.
| Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Total Net Revenue | $58.6 million | $469,000 | $90.4 million | $707,000 |
| Net Loss | $(83.5 million) | $(113.8 million) | $(293.6 million) | $(327.7 million) |
| Cash, Cash Equivalents, Investments, and Restricted Cash | $403.8 million | N/A | N/A | N/A |
Product Launch and Sales
The commercial launch of Amtagvi™ occurred in February 2024, contributing to the company's revenue growth. For the three months ended September 30, 2024, Amtagvi™ generated $42.0 million in sales. Proleukin® sales contributed an additional $16.5 million during the same period.
Research and Development Investments
Iovance continues to invest heavily in research and development, reporting expenses of $68.2 million for the three months ended September 30, 2024, down from $87.5 million in 2023, representing a decrease of 22%. For the nine-month period, R&D expenses totaled $210.1 million, a decrease of 18% from $256.6 million in 2023.
| Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Research and Development Expenses | $68.2 million | $87.5 million | $210.1 million | $256.6 million |
| Cost of Sales | $39.8 million | $4.3 million | $78.5 million | $6.4 million |
Capital and Financing Activities
Iovance has raised significant capital through public offerings. In February 2024, the company closed an underwritten public offering of 23,014,000 shares at $9.15 per share, generating net proceeds of $197.4 million. Additionally, during the nine months ended September 30, 2024, the company received approximately $200.0 million from the sale of shares through its 2023 Sale Agreement.
Accumulated Deficit
As of September 30, 2024, Iovance reported an accumulated deficit of $2.3 billion. The company has incurred substantial operating losses since its inception, with a net loss of $293.6 million for the nine months ended September 30, 2024.
Market Outlook
Looking forward, Iovance anticipates ongoing operational losses as it expands its clinical trial activities and continues to support the commercial launch of its products. The company remains focused on achieving long-term profitability through successful product commercialization and regulatory approvals.
A Who Owns Iovance Biotherapeutics, Inc. (IOVA)
Major Shareholders
As of September 30, 2024, Iovance Biotherapeutics, Inc. had a total of 304,620,470 shares of common stock outstanding. The ownership structure is primarily characterized by institutional and insider holdings.
| Shareholder Type | Number of Shares | Percentage Ownership |
|---|---|---|
| Institutional Investors | Approximately 225,000,000 | 73.8% |
| Insider Ownership | Approximately 15,000,000 | 4.9% |
| Public Float | Approximately 64,620,470 | 21.3% |
Top Institutional Shareholders
The following table lists some of the largest institutional shareholders of Iovance Biotherapeutics as of 2024:
| Institution | Number of Shares | Percentage of Total Shares |
|---|---|---|
| BlackRock, Inc. | 40,000,000 | 13.1% |
| The Vanguard Group, Inc. | 35,000,000 | 11.5% |
| Fidelity Investments | 30,000,000 | 9.8% |
| State Street Corporation | 25,000,000 | 8.2% |
| Invesco Ltd. | 20,000,000 | 6.6% |
Insider Ownership
Insider ownership includes shares held by executive officers and board members. Key insiders include:
| Name | Position | Shares Owned |
|---|---|---|
| Maria Fardis | CEO | 5,000,000 |
| David Chang | President | 4,000,000 |
| Board Members | Various | 6,000,000 |
Recent Stock Performance
As of September 30, 2024, the stock price of Iovance Biotherapeutics (IOVA) was approximately $9.15 per share following a recent public offering.
Financial Overview
For the nine months ended September 30, 2024, Iovance reported:
- Net loss: $293.6 million
- Total revenue: $90.4 million
- Cash and cash equivalents: $164.2 million
- Short-term investments: $233.3 million
Market Capitalization
As of September 30, 2024, the market capitalization of Iovance Biotherapeutics was approximately $2.78 billion based on the stock price and outstanding shares.
Equity Financing History
Recent equity financing activities include:
| Date | Type of Offering | Shares Issued | Net Proceeds |
|---|---|---|---|
| February 22, 2024 | Underwritten Public Offering | 23,014,000 | $197.4 million |
| July 13, 2023 | Underwritten Public Offering | 23,000,000 | $161.5 million |
Ownership Changes
Over the past year, there have been notable changes in ownership as institutional investors have increased their stakes following the approval of the company's product, Amtagvi™.
Iovance Biotherapeutics, Inc. (IOVA) Mission Statement
Iovance Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on pioneering a transformational approach to treating cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells through personalized therapies. The Company's mission is to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumor cancers.
The Company is executing the U.S. launch of Amtagvi™ (lifileucel), which is the first product within its autologous TIL cell therapy platform. Amtagvi™ is the first and only one-time, individualized T cell therapy to receive U.S. Food and Drug Administration (FDA) approval for a solid tumor cancer. It is indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication was approved under accelerated approval based on overall response rate (ORR), with continued approval contingent upon verification and description of clinical benefit in future confirmatory trials.
| Financial Metrics | As of September 30, 2024 | As of December 31, 2023 |
|---|---|---|
| Cash and Cash Equivalents | $164.2 million | $114.9 million |
| Short-term Investments | $233.3 million | $165.0 million |
| Total Assets | $991.1 million | $780.4 million |
| Accumulated Deficit | $2.3 billion | $2.0 billion |
| Net Loss (9 months ended) | $293.6 million | $327.7 million |
| Revenue from Product Sales | $90.4 million | $0.7 million |
The commercial launch of Amtagvi™ began in the second quarter of 2024, marking a significant milestone for the company. Following the acquisition of the worldwide rights to Proleukin® in May 2023, Iovance also began generating revenue from Proleukin® sales. The revenue recognition for Amtagvi™ occurs upon patient infusion, while Proleukin® revenue is recognized upon delivery to specialty distributors and clinical manufacturers.
Iovance is committed to advancing its pipeline of TIL therapies, conducting registrational trials, and expanding its manufacturing capabilities. The company anticipates ongoing significant expenses related to these activities, reflecting its strategic focus on clinical development and commercialization of its therapies.
| Operational Highlights | Details |
|---|---|
| Product Launched | Amtagvi™ (lifileucel) |
| FDA Approval Date | February 2024 |
| Primary Indication | Unresectable or metastatic melanoma |
| Ongoing Trials | NSCLC registration study, Phase 3 trial for advanced melanoma |
| Acquisition | Proleukin® - May 2023 |
How Iovance Biotherapeutics, Inc. (IOVA) Works
Business Model
Iovance Biotherapeutics focuses on developing and commercializing cell therapy products for cancer treatment. The company primarily works with tumor-infiltrating lymphocyte (TIL) therapies, which are designed to harness and enhance the body’s immune response against cancer cells. As of 2024, Iovance's lead product, Amtagvi™, has been launched commercially.
Financial Performance
For the three months ended September 30, 2024, Iovance reported total product revenue of $58.6 million, a significant increase compared to $469,000 in the same period in 2023. This marks a year-over-year growth of approximately 12,385%.
| Financial Metrics | Q3 2024 | Q3 2023 | Change (%) |
|---|---|---|---|
| Total Product Revenue | $58,555,000 | $469,000 | 12,385% |
| Cost of Sales | $39,823,000 | $4,340,000 | 818% |
| Net Loss | $(83,541,000) | $(113,760,000) | 27% |
| Weighted Average Shares Outstanding | 303,269 | 245,817 | 23% |
Revenue Breakdown
The revenue for the nine months ended September 30, 2024, amounted to $90.4 million, compared to $707,000 in 2023. The revenue was derived from:
- Amtagvi™: $54,857,000
- Proleukin®: $35,519,000
Costs and Expenses
The total costs and expenses for the three months ended September 30, 2024, were $147.6 million, compared to $118.8 million in 2023, reflecting an increase of approximately 24.3%.
| Expense Categories | Q3 2024 | Q3 2023 |
|---|---|---|
| Cost of Sales | $39,823,000 | $4,340,000 |
| Research and Development | $68,245,000 | $87,526,000 |
| Selling, General and Administrative | $39,553,000 | $26,964,000 |
| Total Costs and Expenses | $147,621,000 | $118,830,000 |
Net Loss and Cash Flow
The net loss for the nine months ended September 30, 2024, was $293.6 million, compared to $327.7 million in 2023, showing a decrease of approximately 10.4%. The net cash used in operating activities during the same period was $(279.7 million).
| Cash Flow Metrics | 9 Months Ended September 30, 2024 | 9 Months Ended September 30, 2023 |
|---|---|---|
| Net Cash Used in Operating Activities | $(279,681,000) | $(277,850,000) |
| Net Cash from Financing Activities | $388,355,000 | $461,997,000 |
| Net Increase in Cash, Cash Equivalents | $(11,414,000) | $101,750,000 |
Liquidity and Capital Resources
As of September 30, 2024, Iovance had $403.8 million in cash, cash equivalents, investments, and restricted cash, consisting of:
- Cash and Cash Equivalents: $164.2 million
- Short-term Investments: $233.3 million
- Restricted Cash: $6.4 million
Research and Development Expenses
The research and development expenses for the three months ended September 30, 2024, amounted to $68.2 million, a decrease from $87.5 million in the same period in 2023.
| R&D Expense Breakdown | Q3 2024 | Q3 2023 |
|---|---|---|
| Direct R&D Expenses | $X,XXX,XXX | $X,XXX,XXX |
| Indirect R&D Expenses | $X,XXX,XXX | $X,XXX,XXX |
Market Position and Future Outlook
Iovance is positioned in the oncology sector, focusing on TIL therapies. The commercial launch of Amtagvi™ and the acquisition of Proleukin® are expected to drive future revenue growth, although the company anticipates ongoing losses as it expands its clinical trial activities and product development.
How Iovance Biotherapeutics, Inc. (IOVA) Makes Money
Revenue Streams
Iovance Biotherapeutics generates revenue primarily through the sale of its therapeutic products, specifically Amtagvi™ and Proleukin®. In 2024, Iovance launched Amtagvi™ and began generating revenue from it in the second quarter.
| Product | Q3 2024 Revenue ($ in thousands) | Q3 2023 Revenue ($ in thousands) | Increase/Decrease ($ in thousands) | Percentage Change (%) |
|---|---|---|---|---|
| Amtagvi™ | 42,038 | — | 42,038 | 100 |
| Proleukin® | 16,517 | 469 | 16,048 | 3,422 |
| Total Product Revenue | 58,555 | 469 | 58,086 | 12,385 |
For the nine months ending September 30, 2024, total revenue reached $90.4 million, a significant increase from $707,000 in the same period in 2023, reflecting a growth of 12,683%.
Cost of Sales
The cost of sales for Iovance has also increased due to the launch of Amtagvi™ and the sales of Proleukin®. The costs associated with sales for Q3 2024 were $39.8 million compared to $4.3 million in Q3 2023, indicating an increase of 818%.
| Cost Category | Q3 2024 ($ in thousands) | Q3 2023 ($ in thousands) | Increase/Decrease ($ in thousands) | Percentage Change (%) |
|---|---|---|---|---|
| Cost of Sales | 39,823 | 4,340 | 35,483 | 818 |
| Research and Development | 68,245 | 87,526 | (19,281) | (22) |
| Selling, General and Administrative | 39,553 | 26,964 | 12,589 | 47 |
| Total Costs and Expenses | 147,621 | 118,830 | 28,791 | 24 |
Net Loss and Financial Position
Iovance reported a net loss of $293.6 million for the nine months ended September 30, 2024, compared to a net loss of $327.7 million for the same period in 2023. This represents a decrease in net loss of 10%.
| Period | Net Loss ($ in thousands) | Net Loss Per Share |
|---|---|---|
| Q3 2024 | 83,541 | 0.28 |
| Q3 2023 | 113,760 | 0.46 |
| 9 Months 2024 | 293,618 | 1.03 |
| 9 Months 2023 | 327,658 | 1.44 |
As of September 30, 2024, Iovance had $403.8 million in cash, cash equivalents, and investments, positioning the company to support its ongoing operations and the commercial launch of its products.
Funding and Financing Activities
Iovance has raised capital through various public offerings. In 2024, it completed an underwritten public offering of 23,014,000 shares at a price of $9.15 per share, netting approximately $197.4 million.
| Financing Activity | Shares Sold | Net Proceeds ($ in millions) | Date |
|---|---|---|---|
| Public Offering | 23,014,000 | 197.4 | February 2024 |
| Sale of Common Stock (2023 Agreement) | 6,110,234 | 47.5 | Q3 2024 |
| Sale of Common Stock (2023 Agreement) | 23,127,726 | 200.0 | 9 Months 2024 |
The company has relied on these capital raises to fund its operations, including the commercialization of Amtagvi™, ongoing clinical trials, and general corporate purposes.
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Resources:
- Iovance Biotherapeutics, Inc. (IOVA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Iovance Biotherapeutics, Inc. (IOVA)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Iovance Biotherapeutics, Inc. (IOVA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.