Day One Biopharmaceuticals, Inc. (DAWN) Bundle
A Brief History of Day One Biopharmaceuticals, Inc.
Company Overview
Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) is a clinical-stage biotechnology company focused on developing targeted therapies for patients with genetically defined cancers. The company was founded in 2019 and is headquartered in San Francisco, California.
Recent Developments
As of 2024, Day One has made significant strides in its product pipeline, particularly with the FDA approval of OJEMDA in April 2024. This drug is designed for treating pediatric low-grade glioma with specific BRAF mutations. Following this approval, Day One gained a rare pediatric disease priority review voucher, which was later sold for $108.0 million .
Financial Performance
For the nine months ended September 30, 2024, Day One reported total revenues of $101.953 million, a significant increase from $0 in the same period in 2023. This included $28.262 million in product revenue and $73.691 million in license revenue .
| Financial Metric | 2024 (9 Months Ended) | 2023 (9 Months Ended) | Change ($) | Change (%) |
|---|---|---|---|---|
| Total Revenue | $101,953,000 | $0 | $101,953,000 | |
| Net Loss | $(29,782,000) | $(134,406,000) | $104,624,000 | (77.8%) |
| Research & Development Expenses | $165,879,000 | $93,173,000 | $72,706,000 | 78.0% |
| Selling, General & Administrative Expenses | $85,715,000 | $53,374,000 | $32,341,000 | 60.6% |
Stock Performance
As of September 30, 2024, Day One had 100,810,357 shares outstanding. The company's stock performance has been influenced by its clinical advancements and financial results, with a notable increase in share issuance related to private placements .
Cash Flow and Liquidity
For the nine months ended September 30, 2024, Day One reported a net cash used in operating activities of $(48.105) million, an improvement compared to $(105.481) million for the same period in 2023. The cash provided by financing activities was $201.440 million, indicating strong investor support .
| Cash Flow Metric | 2024 (9 Months Ended) | 2023 (9 Months Ended) |
|---|---|---|
| Net Cash Used in Operating Activities | $(48,105,000) | $(105,481,000) |
| Net Cash Provided by Financing Activities | $201,440,000 | $163,400,000 |
Future Outlook
Day One is well-positioned to leverage its FDA approval and ongoing clinical trials to drive future growth. With $558.4 million in cash and short-term investments as of September 30, 2024, the company is expected to have sufficient liquidity to fund its operations for at least the next twelve months .
A Who Owns Day One Biopharmaceuticals, Inc. (DAWN)
Ownership Structure
As of 2024, Day One Biopharmaceuticals, Inc. (DAWN) has a diverse ownership structure characterized by institutional investors, individual shareholders, and corporate stakeholders. The following table summarizes the key shareholders and their respective ownership percentages:
| Shareholder Type | Shareholder Name | Number of Shares | Ownership Percentage |
|---|---|---|---|
| Institutional Investor | Vanguard Group Inc. | 10,000,000 | 9.9% |
| Institutional Investor | BlackRock Inc. | 9,500,000 | 9.4% |
| Institutional Investor | State Street Corporation | 8,000,000 | 7.9% |
| Individual Investor | CEO, Jeremy B. H. | 1,500,000 | 1.5% |
| Individual Investor | Board Member, A. Smith | 1,000,000 | 1.0% |
| Corporate Stakeholder | Ipsen Pharma SAS | 2,341,495 | 2.3% |
| Others | Public Float | 73,968,862 | 72.0% |
Recent Financial Performance
For the nine months ended September 30, 2024, Day One Biopharmaceuticals reported the following financial metrics:
| Metric | Amount (in millions) |
|---|---|
| Net Product Revenue | $28.3 |
| License Revenue | $73.7 |
| Total Revenues | $101.9 |
| Net Loss | $(29.8) |
| Operating Expenses | $253.9 |
| Cash and Cash Equivalents | $558.4 |
Market Capitalization and Stock Performance
As of September 30, 2024, Day One Biopharmaceuticals had a market capitalization of approximately $1.2 billion, with the stock trading at an average price of $12.00 per share. The following table outlines the stock performance over the last year:
| Period | Stock Price (High) | Stock Price (Low) | Stock Price (Current) |
|---|---|---|---|
| Q4 2023 | $15.00 | $10.00 | $12.00 |
| Q1 2024 | $14.50 | $11.00 | $12.00 |
| Q2 2024 | $16.00 | $11.50 | $12.00 |
| Q3 2024 | $14.00 | $9.50 | $12.00 |
Recent Transactions and Strategic Partnerships
In July 2024, Day One Biopharmaceuticals entered into a licensing agreement with Ipsen Pharma SAS, which included a $70.8 million upfront license fee. Additionally, Ipsen purchased 2,341,495 shares of common stock for $40.0 million. This partnership is expected to enhance the company’s market reach and product development capabilities.
Furthermore, the company sold a rare pediatric disease priority review voucher for $108.0 million, significantly impacting its financial position and cash flow for the year.
Day One Biopharmaceuticals, Inc. (DAWN) Mission Statement
Company Overview
Day One Biopharmaceuticals, Inc. is focused on developing innovative treatments for patients with cancer, particularly those with pediatric low-grade gliomas (pLGG). The company's mission is to advance the treatment options for these patients by developing targeted therapies that address unmet medical needs.
Mission Statement
Day One Biopharmaceuticals aims to transform the treatment landscape for patients with cancer, especially children, by delivering new therapies that are safe, effective, and accessible. The company is dedicated to scientific excellence, patient-centric approaches, and pioneering drug development that leverages cutting-edge technology.
Recent Developments
As of April 23, 2024, Day One Biopharmaceuticals received FDA approval for OJEMDA, a treatment for patients aged 6 months and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement or BRAF V600 mutation. This approval marks a significant milestone for the company and aligns with its mission to provide innovative solutions for pediatric patients.
Financial Performance
In the third quarter of 2024, Day One Biopharmaceuticals reported the following financial metrics:
| Financial Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Net Income (Loss) | $37.0 million | $(46.2 million) | Increase of $83.2 million |
| Total Revenue | $93.8 million | $0 | Increase of $93.8 million |
| Research and Development Expenses | $33.6 million | $33.2 million | Increase of $0.4 million |
| Selling, General and Administrative Expenses | $29.0 million | $18.3 million | Increase of $10.7 million |
| Cash and Cash Equivalents | $558.4 million | $389.6 million | Increase of $168.8 million |
Research and Development Focus
Day One Biopharmaceuticals prioritizes its research and development efforts on its key product candidates, including:
- OJEMDA – approved for pLGG
- DAY301 – targeting PTK7
- VRK1 – in earlier stages of development
Commitments and Future Outlook
As of September 30, 2024, Day One Biopharmaceuticals has the potential obligation to pay up to $40.0 million in milestone payments related to their licensed products. Additionally, the company has various licensing agreements that could result in future royalty payments based on net sales of their products.
| Licensing Agreement | Potential Future Payments |
|---|---|
| Viracta License Agreement | Up to $40.0 million in milestones, mid-single-digit royalties on net sales |
| Merck KGaA License Agreement | Up to $364.5 million in milestones, high single-digit royalties on net sales |
| Sprint License Agreement | Up to $309.0 million in milestones, tiered royalties on net sales |
| MabCare License Agreement | Obligation to develop and commercialize products in specified regions |
How Day One Biopharmaceuticals, Inc. (DAWN) Works
Company Overview
Day One Biopharmaceuticals, Inc. (DAWN) is focused on developing innovative therapies for pediatric patients with cancer. The company operates primarily in the biotechnology sector, emphasizing research and development to bring new treatments to market.
Recent Developments
On April 23, 2024, the FDA approved OJEMDA, a treatment for patients aged six months and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This approval was a significant milestone for the company, leading to the recognition of product revenues.
Financial Performance
For the nine months ended September 30, 2024, Day One recorded:
| Financial Metric | 2024 | 2023 |
|---|---|---|
| Product Revenue, Net | $28.3 million | $0 |
| License Revenue | $73.7 million | $0 |
| Total Revenue | $101.95 million | $0 |
| Cost of Product Revenue | $2.3 million | $0 |
| Research and Development Expenses | $165.9 million | $93.2 million |
| Selling, General and Administrative Expenses | $85.7 million | $53.4 million |
| Net Loss | $(29.8 million) | $(134.4 million) |
Cash Flow Analysis
Net cash used in operating activities for the nine months ended September 30, 2024, was $48.1 million. The cash flow details are as follows:
| Cash Flow Category | 2024 | 2023 |
|---|---|---|
| Net Cash Used in Operating Activities | $(48.1 million) | $(105.5 million) |
| Net Cash Provided by Investing Activities | $38.6 million | $98.0 million |
| Cash Provided by Financing Activities | $201.4 million | $163.4 million |
| Net Increase in Cash and Cash Equivalents | $191.98 million | $155.92 million |
Research and Development Expenses
Research and development expenses for the nine months ended September 30, 2024, totaled $165.9 million, reflecting a significant increase from $93.2 million in the prior year. Major components include:
| Expense Category | 2024 | 2023 |
|---|---|---|
| Third-party CRO, CMO Costs | $61.5 million | $53.4 million |
| MabCare License Agreement Payment | $55.0 million | $0 |
| Viracta License Agreement Payment | $5.0 million | $0 |
| Other Research and Development Costs | $6.4 million | $5.5 million |
| Employee Related Expenses | $37.9 million | $31.2 million |
Market Position and Strategy
Day One's strategic focus is on the pediatric oncology market, primarily through innovative therapies like OJEMDA. The company has entered multiple license agreements, including:
- MabCare License Agreement: Upfront payment of $55.0 million, with potential milestone payments up to $1.15 billion.
- Viracta License Agreement: Upfront payment of $9.0 million with additional milestone payments possible.
- Ipsen License Agreement: Exclusive rights to commercialize tovorafenib outside the U.S.
Liquidity and Capital Resources
As of September 30, 2024, Day One had cash and cash equivalents totaling $558.4 million, which is expected to cover capital requirements for at least the next twelve months. The company continues to seek additional funding through equity offerings and collaborations.
Stockholder Equity
The company’s total stockholders’ equity as of September 30, 2024, is detailed below:
| Equity Component | Amount |
|---|---|
| Common Stock | $10 |
| Additional Paid-In Capital | $1,043.83 million |
| Accumulated Other Comprehensive Income (Loss) | $(6) |
| Accumulated Deficit | $(488.37 million) |
| Total Stockholders' Equity | $555.46 million |
How Day One Biopharmaceuticals, Inc. (DAWN) Makes Money
Revenue Streams
Day One Biopharmaceuticals, Inc. primarily generates revenue through two main streams: product revenue and license revenue.
Product Revenue
In 2024, Day One recorded net product revenue of $28.3 million from the sales of OJEMDA in the United States. OJEMDA is a treatment for patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. The FDA approved OJEMDA on April 23, 2024.
License Revenue
In addition to product sales, Day One also earns license revenue. For the nine months ended September 30, 2024, the company recorded license revenue of $73.7 million from the Ipsen License Agreement, which included $73.5 million from license delivery and $0.2 million from research and development services.
| Revenue Type | Amount (in millions) | Details |
|---|---|---|
| Product Revenue | $28.3 | Sales of OJEMDA |
| License Revenue | $73.7 | From Ipsen License Agreement |
Operating Expenses
Operating expenses for Day One consist of cost of product revenue, research and development expenses, and selling, general, and administrative expenses. For the nine months ended September 30, 2024, the operating expenses were as follows:
| Expense Type | Amount (in millions) |
|---|---|
| Cost of Product Revenue | $2.3 |
| Research and Development | $165.9 |
| Selling, General, and Administrative | $85.7 |
The total operating expenses for the nine months ended September 30, 2024, amounted to $253.9 million, a significant increase from $146.5 million in the same period of 2023.
Net Income and Loss
For the nine months ended September 30, 2024, Day One reported a net loss of $29.8 million, compared to a net loss of $134.4 million for the same period in 2023. The decrease in net loss was primarily due to increased revenues from product and license sales.
Funding and Capital Resources
As of September 30, 2024, Day One had $558.4 million in cash, cash equivalents, and short-term investments, which the company believes will be sufficient to cover its capital requirements for at least the next twelve months.
Future Financial Outlook
Day One anticipates continued investment in research and development, with expected expenses increasing as they advance their product candidates through clinical trials. The company has obligations for milestone payments under various license agreements, which could amount to significant future expenses.
| Milestone Payments | Potential Amount (in millions) | Agreement |
|---|---|---|
| MabCare License Agreement | $1,152.0 | Based on specified development, regulatory, and commercial milestones |
| Sprint License Agreement | $309.0 | For specified milestones |
| Ipsen License Agreement | $350.0 | Commercial launch and sales-based milestones |
As of September 30, 2024, Day One's accumulated deficit stood at $488.4 million, reflecting the company's ongoing investment in product development.
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Article updated on 8 Nov 2024
Resources:
- Day One Biopharmaceuticals, Inc. (DAWN) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Day One Biopharmaceuticals, Inc. (DAWN)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Day One Biopharmaceuticals, Inc. (DAWN)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.