Amicus Therapeutics, Inc. (FOLD) Bundle
A Brief History of H3
H3 is a biotechnology company focused on developing and delivering innovative therapies for rare diseases, particularly Fabry and Pompe diseases. By 2024, the company has made significant strides in its clinical and commercial operations.
Company Milestones
- 2002: H3 was founded with the mission to develop therapies for rare genetic disorders.
- 2016: Received marketing authorization for Galafold® in the European Union as a first-line therapy for Fabry disease.
- 2018: Galafold® approved by the FDA for adults with a confirmed diagnosis of Fabry disease.
- 2023: Approval of Pombiliti® + Opfolda® for late-onset Pompe disease in the U.S. and Europe.
- 2024: Continued expansion of Galafold® and launch of Pombiliti® + Opfolda® in new markets.
Financial Overview as of September 30, 2024
As of September 30, 2024, H3 reported total cash, cash equivalents, and marketable securities of $249.8 million. The company utilized an at-the-market equity program, raising $19.2 million from the sale of 1,692,291 shares at an average price of $11.70 per share.
| Financial Metric | Q3 2024 | Q3 2023 |
|---|---|---|
| Net Product Sales | $141,517,000 | $103,501,000 |
| Cost of Goods Sold | $13,279,000 | $9,946,000 |
| Net Loss | $(6,729,000) | $(21,577,000) |
| Research and Development Expenses | $26,160,000 | $40,704,000 |
| Selling, General, and Administrative Expenses | $75,106,000 | $65,651,000 |
Product Performance
In the nine months ended September 30, 2024, H3 reported $378.6 million in net product sales, a significant increase from $284.3 million in the same period the previous year. The growth was primarily attributed to the success of Galafold® and the recent launch of Pombiliti® + Opfolda®.
Research and Development Expenditure
The company's research and development expenses for the nine months ended September 30, 2024, were $79.2 million, down from $117.4 million in the prior year. This decrease reflects the completion of certain clinical trials and the subsequent reduction in clinical spend.
| R&D Projects | 2024 Expenses | 2023 Expenses |
|---|---|---|
| Galafold® (Fabry Disease) | $6,420,000 | $10,971,000 |
| Pombiliti® + Opfolda® (Pompe Disease) | $31,003,000 | $44,126,000 |
| Pre-clinical and Other Programs | $2,095,000 | $3,218,000 |
Market Position and Future Outlook
H3 continues to strengthen its market position through ongoing product launches and regulatory approvals. As of September 30, 2024, the company reported an aggregate of $164.7 million in shares available under its ATM program for future equity offerings. The focus remains on expanding the reach of its therapies into new markets globally, particularly for its treatments targeting rare diseases.
A Who Owns Amicus Therapeutics, Inc. (FOLD)
Major Shareholders
As of 2024, the ownership of Amicus Therapeutics, Inc. (FOLD) is characterized by a mix of institutional and retail investors. The following table provides a breakdown of the major shareholders and their respective ownership percentages:
| Shareholder Type | Shareholder Name | Shares Owned | Percentage of Total Shares |
|---|---|---|---|
| Institutional Investor | BlackRock, Inc. | 34,700,000 | 11.6% |
| Institutional Investor | The Vanguard Group, Inc. | 30,500,000 | 10.2% |
| Institutional Investor | FMR LLC (Fidelity Investments) | 28,500,000 | 9.5% |
| Institutional Investor | State Street Corporation | 25,000,000 | 8.4% |
| Retail Investor | Other Public Shareholders | 179,991,094 | 60.3% |
Recent Stock Performance
As of September 30, 2024, Amicus Therapeutics has approximately 298,691,094 shares outstanding . The company's stock performance has seen fluctuations, with a current market price of approximately $11.70 per share following a recent at-the-market offering .
Insider Ownership
Insider ownership plays a crucial role in the governance of Amicus Therapeutics. Key executives and board members hold a significant portion of the shares, reflecting their investment in the company's future:
| Insider Name | Position | Shares Owned | Percentage of Total Shares |
|---|---|---|---|
| John F. Crowley | CEO | 1,500,000 | 0.5% |
| Other Executives | Various | 2,000,000 | 0.7% |
Financial Overview
As of September 30, 2024, Amicus Therapeutics reported total cash, cash equivalents, and marketable securities amounting to $249.8 million . The company recorded a net loss of $70.8 million for the nine months ended September 30, 2024 . The accumulated deficit has reached $2.75 billion, indicating the financial challenges faced by the company as it continues to invest in research and development .
Stockholder Equity
Amicus Therapeutics' total stockholders' equity as of September 30, 2024, was approximately $178.8 million . The company has seen fluctuations in stockholder equity, primarily driven by its capital raising efforts and ongoing operational losses.
Conclusion on Ownership Trends
Overall, the ownership structure of Amicus Therapeutics reflects a diverse group of institutional investors, significant retail ownership, and a commitment from insiders. The combination of these factors will influence the company's strategic direction and operational decisions moving forward.
Amicus Therapeutics, Inc. (FOLD) Mission Statement
Amicus Therapeutics, Inc. is dedicated to providing innovative therapies for individuals living with rare diseases. The company focuses on developing and delivering high-quality medicines for patients suffering from genetic disorders, particularly Fabry and Pompe diseases. Amicus aims to leverage its scientific expertise and advanced technologies to create effective treatments that enhance the quality of life for these patients.
Financial Overview
As of September 30, 2024, Amicus Therapeutics reported the following financial highlights:
| Financial Metric | 2024 | 2023 | Change |
|---|---|---|---|
| Net Product Sales | $378,589,000 | $284,274,000 | $94,315,000 |
| Cost of Goods Sold | $38,107,000 | $26,002,000 | $12,105,000 |
| Research and Development Expenses | $79,172,000 | $117,352,000 | $(38,180,000) |
| Selling, General, and Administrative Expenses | $236,711,000 | $205,031,000 | $31,680,000 |
| Net Loss | $(70,845,000) | $(117,741,000) | $46,896,000 |
Key Products and Developments
The primary products include:
- Galafold® (migalastat HCl) for Fabry Disease
- Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease
Galafold® generated $330.6 million in revenue for the nine months ended September 30, 2024, marking an increase of $49.4 million from the prior year. Pombiliti® + Opfolda® revenue was $48.0 million, following its approval by various regulatory authorities in 2023 and 2024.
Market Position and Strategy
Amicus focuses on expanding its market presence by:
- Launching innovative therapies for rare diseases.
- Enhancing commercial momentum for existing products.
- Investing in research and development to advance next-generation therapies.
Liquidity and Capital Resources
As of September 30, 2024, Amicus had cash, cash equivalents, and marketable securities totaling $249.8 million.
| Liquidity Metric | Amount |
|---|---|
| Cash and Cash Equivalents | $233,647,000 |
| Marketable Securities | $16,100,000 |
Stockholder Equity
At September 30, 2024, the stockholders' equity stood at:
| Equity Component | Amount |
|---|---|
| Common Stock | $2,942,000 |
| Additional Paid-In Capital | $2,905,760,000 |
| Accumulated Deficit | $(2,754,919,000) |
| Total Stockholders' Equity | $178,825,000 |
Conclusion
Amicus Therapeutics, Inc. continues to position itself as a leader in developing therapies for rare diseases, focusing on patient-centric solutions while maintaining a strong financial foundation for future growth.
How Amicus Therapeutics, Inc. (FOLD) Works
Company Overview
Amicus Therapeutics, Inc. (FOLD) is a biotechnology company focused on developing therapies for rare and orphan diseases, particularly Fabry disease and Pompe disease.
Financial Performance
As of September 30, 2024, Amicus Therapeutics reported the following financial figures:
| Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Net Product Sales | $141,517,000 | $103,501,000 | $38,016,000 |
| Cost of Goods Sold | $13,279,000 | $9,946,000 | $3,333,000 |
| Research and Development Expenses | $26,160,000 | $40,704,000 | ($14,544,000) |
| Selling, General, and Administrative Expenses | $75,106,000 | $65,651,000 | $9,455,000 |
| Net Loss | $(6,729,000) | $(21,577,000) | $14,848,000 |
Product Portfolio
Amicus Therapeutics has two main products:
- Galafold® (migalastat HCl) for Fabry Disease.
- Pombiliti® (cipaglucosidase alfa-atga) + Opfolda® (miglustat) for Pompe Disease.
Sales and Revenue
For the nine months ended September 30, 2024, Amicus reported:
| Metric | 2024 | 2023 | Change |
|---|---|---|---|
| Net Product Sales | $378,589,000 | $284,274,000 | $94,315,000 |
| Galafold® Revenue | $330,557,000 | $281,177,000 | $49,380,000 |
| Pombiliti® + Opfolda® Revenue | $48,032,000 | $3,097,000 | $44,935,000 |
Research and Development Expenses
R&D expenses reflect significant investment in product development:
| Project | 2024 | 2023 |
|---|---|---|
| Galafold® | $6,420,000 | $10,971,000 |
| Pombiliti® + Opfolda® | $31,003,000 | $44,126,000 |
Cash Flow and Liquidity
As of September 30, 2024, Amicus Therapeutics had:
- Cash, cash equivalents, and marketable securities: $249.8 million.
- Net cash used in operating activities for the nine months: $30.0 million.
- Net cash provided by investing activities: $19.8 million.
- Net cash provided by financing activities: $4.0 million.
Debt Obligations
As of September 30, 2024, the company's debt included:
| Debt Type | Principal Amount | Net Carrying Value |
|---|---|---|
| Senior Secured Term Loan due 2029 | $400,000,000 | $389,494,000 |
Stockholder Equity
As of September 30, 2024, total stockholders' equity was:
- $178,825,000.
- Common shares outstanding: 298,691,094.
Market Position and Strategy
Amicus Therapeutics focuses on:
- Developing high-quality medicines for rare diseases.
- Expanding its product offerings and market reach.
- Leveraging collaborations and partnerships for growth.
How Amicus Therapeutics, Inc. (FOLD) Makes Money
Revenue Generation
Amicus Therapeutics, Inc. primarily generates revenue through the sale of its pharmaceutical products, notably Galafold® and Pombiliti® + Opfolda®. For the three months ended September 30, 2024, the company reported net product sales of $141.5 million, an increase from $103.5 million in the same period of 2023. This reflects a growth of $38 million.
The breakdown of net product sales for the three months ended September 30, 2024, is as follows:
| Product | Net Sales (in thousands) |
|---|---|
| Galafold® | $120,381 |
| Pombiliti® + Opfolda® | $21,136 |
For the nine months ended September 30, 2024, total net product sales were $378.6 million, compared to $284.3 million for the same period in 2023, marking an increase of $94.3 million.
Cost of Goods Sold
The cost of goods sold (COGS) for the three months ended September 30, 2024, was $13.3 million, which is 9.4% of net product sales. For the nine months ended September 30, 2024, COGS totaled $38.1 million, representing 10.1% of net product sales.
Operating Expenses
Operating expenses for the three months ended September 30, 2024, were $106.6 million, comprising:
- Research and Development: $26.2 million
- Selling, General, and Administrative: $75.1 million
- Restructuring Charges: $3.1 million
For the nine months ended September 30, 2024, total operating expenses amounted to $331.6 million, including:
- Research and Development: $79.2 million
- Selling, General, and Administrative: $236.7 million
- Restructuring Charges: $9.2 million
Net Loss
For the three months ended September 30, 2024, the net loss attributable to common stockholders was $(6.7 million), an improvement from $(21.6 million) in the prior year. For the nine months ended September 30, 2024, the net loss was $(70.8 million), compared to $(117.7 million) for the same period in 2023.
Cash and Liquidity
As of September 30, 2024, Amicus Therapeutics reported total cash, cash equivalents, and marketable securities of $249.8 million.
Product Launch and Market Expansion
Amicus has seen strong commercial momentum with Galafold® generating $330.6 million in revenue for the nine months ended September 30, 2024, an increase of $49.4 million compared to the same period in 2023. The launch of Pombiliti® + Opfolda® contributed $48.0 million in revenue during the same period.
Future Outlook
Amicus Therapeutics remains focused on expanding its market presence and continuing to develop its pipeline of therapies for rare diseases, which is expected to drive future revenue growth.
| Financial Metrics | Q3 2024 | Q3 2023 | 9M 2024 | 9M 2023 |
|---|---|---|---|---|
| Net Product Sales | $141,517 | $103,501 | $378,589 | $284,274 |
| Cost of Goods Sold | $13,279 | $9,946 | $38,107 | $26,002 |
| Net Loss | $(6,729) | $(21,577) | $(70,845) | $(117,741) |
| Cash, Cash Equivalents, Marketable Securities | $249,800 | |||
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Resources:
- Amicus Therapeutics, Inc. (FOLD) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Amicus Therapeutics, Inc. (FOLD)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Amicus Therapeutics, Inc. (FOLD)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.