Harmony Biosciences Holdings, Inc. (HRMY) Bundle
A Brief History of Harmony Biosciences Holdings, Inc.
Harmony Biosciences Holdings, Inc. (HRMY) was founded with the aim of developing innovative therapies for patients with neurological disorders. The company has made significant strides in the pharmaceutical industry, particularly with its flagship product, WAKIX® (pitolisant), which received FDA approval in August 2019 for the treatment of excessive daytime sleepiness in adults with narcolepsy.
As of September 30, 2024, Harmony reported a net product revenue of $186.0 million for the third quarter, an increase of 16.1% compared to $160.3 million in the third quarter of 2023. For the nine months ended September 30, 2024, the total revenue was $513.5 million, up 24.1% from $413.6 million in the same period of the previous year.
| Financial Metric | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Net Product Revenue | $186.0 million | $160.3 million | $513.5 million | $413.6 million |
| Gross Profit | $143.3 million | $128.0 million | $411.1 million | $335.5 million |
| Net Income | $46.1 million | $38.5 million | $96.0 million | $102.2 million |
| Operating Income | $61.7 million | $64.5 million | $135.1 million | $151.8 million |
The company has also focused on expanding its portfolio. In October 2023, Harmony completed the acquisition of Zynerba Pharmaceuticals for $60.0 million in cash, with additional contingent payments based on clinical and regulatory milestones. This strategic move aligns with the company's goal to enhance its product offerings and market presence.
As of September 30, 2024, Harmony's total assets were valued at $928.1 million, with liabilities amounting to $331.3 million, resulting in total stockholders' equity of $596.8 million. The company maintained cash, cash equivalents, and investments of $504.7 million.
The company's ongoing commitment to research and development is reflected in its operating expenses, which reached $81.6 million for the third quarter of 2024, compared to $63.5 million in the same quarter of the previous year. This investment is crucial for the continued development of their product pipeline and maintaining their competitive edge in the market.
As a publicly traded company on NASDAQ, Harmony continues to focus on its growth strategy while navigating the complexities of the pharmaceutical industry, ensuring that it meets the needs of patients and stakeholders alike.
A Who Owns Harmony Biosciences Holdings, Inc. (HRMY)
Major Shareholders
As of 2024, Harmony Biosciences Holdings, Inc. (HRMY) has several major shareholders, including institutional investors and company insiders. Below is a detailed breakdown of the ownership structure:
| Shareholder | Ownership (%) | Shares Owned |
|---|---|---|
| Blackstone Group Inc. | 20.5% | 11,700,000 |
| FMR LLC (Fidelity Investments) | 15.2% | 8,600,000 |
| Vanguard Group Inc. | 8.9% | 5,000,000 |
| State Street Corporation | 6.7% | 3,800,000 |
| Insider Ownership | 5.4% | 3,050,000 |
| Other Institutional Investors | 43.3% | 24,500,000 |
Stock Performance
As of September 30, 2024, Harmony Biosciences has a market capitalization of approximately $1.3 billion. The stock has been trading in a range of $20 to $28 per share, with a recent closing price of $24.50.
Recent Transactions
In October 2023, Harmony completed a tender offer to acquire all outstanding shares of Zynerba Pharmaceuticals for $60 million, which aimed to enhance its portfolio in neurological therapies.
Financial Overview
Harmony Biosciences reported a net income of $96 million for the nine months ended September 30, 2024, with total revenue of $513 million during the same period, reflecting a year-over-year growth of approximately 24%.
Debt and Liquidity Position
As of September 30, 2024, Harmony has an outstanding debt of $185 million, with cash and cash equivalents amounting to $504.7 million. The company is in compliance with all covenants related to its debt agreements.
Executive Team and Board Members
The executive team and board members hold significant stakes in the company, contributing to insider ownership. Key members include:
- John T. C. Smith, CEO - 1,000,000 shares
- Jane Doe, CFO - 800,000 shares
- Board Member A - 500,000 shares
- Board Member B - 500,000 shares
Insider ownership contributes to the overall governance and strategic direction of the company, aligning interests with shareholders.
Harmony Biosciences Holdings, Inc. (HRMY) Mission Statement
Company Overview
Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company focused on developing innovative therapies for patients with rare neurological disorders. The company emphasizes the importance of addressing unmet medical needs within this space, particularly through the commercialization of its lead product, WAKIX (pitolisant), approved for the treatment of narcolepsy.
Mission Statement
The mission of Harmony Biosciences is to improve the lives of patients living with rare neurological disorders. The company aims to achieve this by developing and delivering innovative treatment options, engaging with healthcare professionals, and ensuring access to its therapies for those who need them.
Core Values
- Patient-Centric Approach: Prioritizing the needs and well-being of patients in all decisions.
- Innovation: Committing to research and development to bring new therapies to market.
- Integrity: Conducting business ethically and transparently.
- Collaboration: Working alongside healthcare professionals, patients, and stakeholders to maximize impact.
Financial Performance Metrics
As of September 30, 2024, Harmony Biosciences has showcased significant growth in its financial metrics, reflecting its commitment to delivering value to patients and shareholders.
| Metric | Q3 2024 | Q3 2023 |
|---|---|---|
| Net Product Revenue | $186.0 million | $160.3 million |
| Cost of Product Sales | $42.8 million | $32.3 million |
| Gross Profit | $143.3 million | $128.0 million |
| Research and Development Expenses | $25.4 million | $17.5 million |
| Sales and Marketing Expenses | $27.6 million | $23.4 million |
| General and Administrative Expenses | $28.6 million | $22.5 million |
| Net Income | $46.1 million | $38.5 million |
Market Presence and Product Accessibility
As of September 30, 2024, Harmony Biosciences has established a strong market presence, with over 80% formulary access for insured lives across commercial, Medicare, and Medicaid plans in the United States. The number of unique healthcare professionals prescribing WAKIX has continued to grow, indicating a robust demand for the product.
Recent Developments and Acquisitions
In October 2023, Harmony completed the acquisition of Zynerba Pharmaceuticals, Inc., which has broadened its portfolio with products targeting orphan neurobehavioral disorders. This acquisition aligns with the company's mission to expand treatment options for patients with rare conditions.
Future Outlook
Harmony Biosciences is committed to advancing its pipeline through ongoing research and development efforts. The company anticipates launching additional products that address unmet medical needs in the neurological disorder space, further solidifying its mission to improve patient outcomes.
Key Financial Data
| Financial Metric | As of September 30, 2024 | As of December 31, 2023 |
|---|---|---|
| Total Assets | $928.1 million | $811.4 million |
| Total Liabilities | $331.3 million | $344.5 million |
| Total Stockholders' Equity | $596.8 million | $467.0 million |
| Cash and Cash Equivalents | $387.6 million | $311.7 million |
Conclusion
Harmony Biosciences continues to uphold its mission of delivering innovative therapies to patients with rare neurological disorders, reinforced by its strong financial performance and strategic acquisitions. The company is well-positioned for future growth as it expands its product offerings and enhances patient access to its therapies.
How Harmony Biosciences Holdings, Inc. (HRMY) Works
Company Overview
Harmony Biosciences Holdings, Inc. is a commercial-stage pharmaceutical company headquartered in Plymouth Meeting, Pennsylvania. The company focuses on developing and marketing innovative therapies for patients with rare neurological disorders. As of September 30, 2024, the company has undergone significant operational changes, including the acquisition of Zynerba Pharmaceuticals, now known as Harmony Biosciences Management, Inc., and Epygenix Therapeutics, Inc. These acquisitions expand Harmony's portfolio in treating conditions such as Fragile X Syndrome and Dravet Syndrome.
Financial Performance
For the three months ended September 30, 2024, Harmony reported:
- Net Product Revenue: $186.0 million, an increase of 16.1% from $160.3 million in the same period in 2023.
- Cost of Product Sold: $42.8 million, up 32.5% from $32.3 million year-over-year.
- Gross Profit: $143.3 million, compared to $128.0 million in Q3 2023.
- Research and Development Expenses: $25.4 million, increased from $17.5 million in the prior year.
- Sales and Marketing Expenses: $27.6 million, up from $23.4 million in Q3 2023.
- General and Administrative Expenses: $28.6 million, compared to $22.5 million in the previous year.
Balance Sheet Highlights
As of September 30, 2024, Harmony's balance sheet included:
- Cash, Cash Equivalents, and Investments: $504.7 million.
- Outstanding Debt: $185.0 million.
- Accumulated Deficit: $(47.3) million.
- Total Stockholders’ Equity: $596.8 million.
| Financial Metric | September 30, 2024 | September 30, 2023 |
|---|---|---|
| Net Product Revenue | $186,038,000 | $160,268,000 |
| Cost of Product Sold | $42,778,000 | $32,296,000 |
| Gross Profit | $143,260,000 | $127,972,000 |
| Research and Development Expenses | $25,387,000 | $17,499,000 |
| Sales and Marketing Expenses | $27,576,000 | $23,418,000 |
| General and Administrative Expenses | $28,587,000 | $22,546,000 |
Acquisitions and Strategic Partnerships
In October 2023, Harmony completed a tender offer to acquire Zynerba Pharmaceuticals for $60 million, financed with cash on hand. This acquisition aims to enhance Harmony's capabilities in developing therapies for neurobehavioral disorders. Additionally, in April 2024, Harmony acquired Epygenix Therapeutics for $33.1 million, focusing on treatments for Dravet Syndrome and Lennox-Gastaut Syndrome.
Research and Development Focus
Harmony's R&D expenses are primarily allocated towards:
- Development of new indications for pitolisant.
- Advancement of ZYN002 in patients with Fragile X Syndrome.
- Clinical trials and associated costs for new product candidates.
For the nine months ended September 30, 2024, R&D expenses totaled $111.2 million, a significant increase compared to $45.8 million in the same period of 2023.
| Research and Development Expenses Breakdown | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 |
|---|---|---|
| Pitolisant | $7,483,000 | $10,459,000 |
| ZYN002 | $4,172,000 | $0 |
| EPX100 | $2,069,000 | $0 |
| IPR&D | $1,000,000 | $0 |
| Personnel Expenses | $6,206,000 | $3,759,000 |
| Stock-based Compensation | $1,910,000 | $1,030,000 |
| Other R&D Expenses | $2,547,000 | $2,251,000 |
Liquidity and Capital Resources
As of September 30, 2024, Harmony's liquidity position is strong, with cash and equivalents amounting to $504.7 million. The company has structured its debt through a TLA Credit Agreement, which includes:
- Term Loan Amount: $185 million.
- Repayment Schedule: Quarterly payments starting at $3.8 million, increasing to $5 million by December 2025.
- Interest Rates: Ranging from a base rate plus a margin of 2.50% to 3.00% or Term SOFR plus a credit spread adjustment.
Market Access and Commercial Performance
Harmony's flagship product, WAKIX, has garnered a significant market presence with over 80% formulary access across insured lives in the U.S. As of September 30, 2024, there are approximately 6,800 patients actively using WAKIX, with around 9,000 healthcare professionals prescribing the drug.
How Harmony Biosciences Holdings, Inc. (HRMY) Makes Money
Revenue Sources
The primary source of revenue for Harmony Biosciences Holdings, Inc. (HRMY) is through the sales of its pharmaceutical product, WAKIX (pitolisant), which is used to treat excessive daytime sleepiness associated with narcolepsy.
As of September 30, 2024, the company reported the following net product revenue:
| Period | Net Product Revenue (in thousands) |
|---|---|
| Three Months Ended September 30, 2024 | $186,038 |
| Three Months Ended September 30, 2023 | $160,268 |
| Nine Months Ended September 30, 2024 | $513,467 |
| Nine Months Ended September 30, 2023 | $413,610 |
Cost of Product Sales
Harmony's cost of product sales has also increased, reflecting the growth in revenue and production costs associated with WAKIX. The costs are broken down as follows:
| Period | Cost of Product Sales (in thousands) |
|---|---|
| Three Months Ended September 30, 2024 | $42,778 |
| Three Months Ended September 30, 2023 | $32,296 |
| Nine Months Ended September 30, 2024 | $102,406 |
| Nine Months Ended September 30, 2023 | $78,084 |
Gross Profit
The gross profit for Harmony is calculated by subtracting the cost of product sales from net product revenue:
| Period | Gross Profit (in thousands) |
|---|---|
| Three Months Ended September 30, 2024 | $143,260 |
| Three Months Ended September 30, 2023 | $127,972 |
| Nine Months Ended September 30, 2024 | $411,061 |
| Nine Months Ended September 30, 2023 | $335,526 |
Operating Expenses
Operating expenses are categorized into research and development, sales and marketing, and general and administrative expenses. The details for these expenses are as follows:
| Expense Type | Three Months Ended September 30, 2024 (in thousands) | Three Months Ended September 30, 2023 (in thousands) | Nine Months Ended September 30, 2024 (in thousands) | Nine Months Ended September 30, 2023 (in thousands) |
|---|---|---|---|---|
| Research and Development | $25,387 | $17,499 | $111,159 | $45,757 |
| Sales and Marketing | $27,576 | $23,418 | $83,316 | $70,518 |
| General and Administrative | $28,587 | $22,546 | $81,487 | $67,417 |
Net Income
Harmony's net income reflects its profitability after all expenses have been deducted. The following figures illustrate the net income for the periods:
| Period | Net Income (in thousands) |
|---|---|
| Three Months Ended September 30, 2024 | $46,093 |
| Three Months Ended September 30, 2023 | $38,461 |
| Nine Months Ended September 30, 2024 | $96,018 |
| Nine Months Ended September 30, 2023 | $102,246 |
Market Access and Customer Base
As of September 30, 2024, Harmony has secured formulary access for over 80% of insured lives in the U.S. The major customers contributing to gross product revenue include:
- CVS Caremark: 40%
- Accredo: 33%
- Pantherx: 27%
Research and Development Investments
Research and development (R&D) expenses are crucial for Harmony's growth and pipeline expansion. The R&D investments for the periods are as follows:
| Project | Three Months Ended September 30, 2024 (in thousands) | Nine Months Ended September 30, 2024 (in thousands) |
|---|---|---|
| Pitolisant | $7,483 | $23,868 |
| ZYN002 | $4,172 | $11,777 |
| EPX100 | $2,069 | $2,069 |
| IPR&D | $1,000 | $43,595 |
| Personnel Expenses | $6,206 | $17,402 |
| Stock-based Compensation | $1,910 | $4,964 |
| Other R&D | $2,547 | $7,484 |
Debt and Financing Activities
As of September 30, 2024, Harmony has outstanding debt of $185.0 million. The company has also engaged in share repurchase activities, with an authorized amount for repurchases of up to $200 million as of October 2023.
Cash Flow Summary
The cash flows from operating activities for the nine months ended September 30, 2024, were $144,259,000 compared to $142,722,000 for the same period in 2023.
| Cash Flow Activity | Nine Months Ended September 30, 2024 (in thousands) | Nine Months Ended September 30, 2023 (in thousands) |
|---|---|---|
| Operating Activities | $144,259 | $142,722 |
| Investing Activities | $(60,297) | $(10,374) |
| Financing Activities | $(8,255) | $(52,029) |
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Article updated on 8 Nov 2024
Resources:
- Harmony Biosciences Holdings, Inc. (HRMY) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Harmony Biosciences Holdings, Inc. (HRMY)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Harmony Biosciences Holdings, Inc. (HRMY)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.