Amicus Therapeutics, Inc. (FOLD) Bundle
Understanding Amicus Therapeutics, Inc. (FOLD) Revenue Streams
Understanding Amicus Therapeutics, Inc. (FOLD) Revenue Streams
Net Product Sales: For the three months ended September 30, 2024, net product sales amounted to $141,517 thousand, compared to $103,501 thousand for the same period in 2023, reflecting an increase of $38,016 thousand, or 36.7%.
For the nine months ended September 30, 2024, net product sales were $378,589 thousand, an increase of $94,315 thousand from $284,274 thousand in the same period of 2023, representing a growth rate of 33.2%.
Revenue Breakdown by Product
Product | Revenue (in thousands) | Percentage of Total Revenue |
---|---|---|
Galafold® | $330,600 | 87.3% |
Pombiliti® + Opfolda® | $48,000 | 12.7% |
Year-over-Year Revenue Growth Rate
The year-over-year revenue growth rate for the three months ended September 30, 2024, was 36.7% compared to the same period in 2023. For the nine months ended September 30, 2024, the growth rate was 33.2%.
Contribution of Different Business Segments to Overall Revenue
During the nine months ended September 30, 2024, Galafold® contributed $330,600 thousand, while Pombiliti® + Opfolda® contributed $48,000 thousand to the total revenue. This demonstrates that Galafold® remains the primary revenue driver, accounting for approximately 87.3% of total revenue.
Operating Expenses Related to Revenue
Operating Expense Type | Q3 2024 (in thousands) | Q3 2023 (in thousands) | Change (in thousands) |
---|---|---|---|
Research and Development | $26,160 | $40,704 | $(14,544) |
Selling, General, and Administrative | $75,106 | $65,651 | $9,455 |
The decrease in research and development expenses by $14,544 thousand was primarily due to the commercial launch of Pombiliti® + Opfolda®, while selling, general, and administrative expenses increased by $9,455 thousand, driven by personnel costs and external services to support sales activities.
Analysis of Significant Changes in Revenue Streams
The significant increase in revenue stems from the ongoing growth of Galafold® in both Europe and the U.S., as well as the recent launch of Pombiliti® + Opfolda®, which has started to contribute to the revenue in 2024. The introduction of these therapies has positively impacted the overall financial performance.
Additionally, the favorable impact of foreign currency exchange contributed approximately $0.8 million to the revenue for the three months ended September 30, 2024.
A Deep Dive into Amicus Therapeutics, Inc. (FOLD) Profitability
A Deep Dive into Amicus Therapeutics, Inc. Profitability
Gross Profit: For the three months ended September 30, 2024, the gross profit was $128,238 thousand, compared to $93,555 thousand for the same period in 2023. For the nine months ended September 30, 2024, the gross profit increased to $340,482 thousand from $258,272 thousand in 2023.
Operating Profit: The income from operations for the three months ended September 30, 2024, was $21,659 thousand, a significant improvement from a loss of $17,023 thousand in the same quarter of 2023. For the nine months, the income from operations stood at $8,905 thousand, up from a loss of $73,519 thousand in 2023.
Net Profit Margin: The net loss attributable to common stockholders for the three months ended September 30, 2024, was $(6,729) thousand, compared to $(21,577) thousand for the same quarter in 2023. For the nine months, the net loss decreased to $(70,845) thousand from $(117,741) thousand in the previous year.
Trends in Profitability Over Time
The following table summarizes the trends in profitability metrics over the past year:
Metric | Q3 2024 | Q3 2023 | Change | 9M 2024 | 9M 2023 | Change |
---|---|---|---|---|---|---|
Gross Profit (thousands) | $128,238 | $93,555 | $34,683 | $340,482 | $258,272 | $82,210 |
Operating Profit (thousands) | $21,659 | $(17,023) | $38,682 | $8,905 | $(73,519) | $82,424 |
Net Loss (thousands) | $(6,729) | $(21,577) | $14,848 | $(70,845) | $(117,741) | $46,896 |
Comparison of Profitability Ratios with Industry Averages
The company's gross margin for the three months ended September 30, 2024, was approximately 90.6%, reflecting an increase compared to 90.4% in Q3 2023. The net profit margin for Q3 2024 was (4.8)%, a considerable improvement from (20.8)% in Q3 2023. This contrasts with the industry average net profit margin of approximately (5.0)% for biopharmaceutical companies.
Analysis of Operational Efficiency
Cost management has shown improvement, with operating expenses for the three months ended September 30, 2024, totaling $106,579 thousand, compared to $110,578 thousand in Q3 2023. The breakdown of operating expenses is as follows:
Expense Type | Q3 2024 (thousands) | Q3 2023 (thousands) | Change (thousands) |
---|---|---|---|
Research and Development | $26,160 | $40,704 | $(14,544) |
Selling, General, and Administrative | $75,106 | $65,651 | $9,455 |
Restructuring Charges | $3,143 | $0 | $3,143 |
Depreciation and Amortization | $2,170 | $2,228 | $(58) |
The gross margin trend has been stable, with a slight decrease in the cost of goods sold as a percentage of net product sales from 9.6% in Q3 2023 to 9.4% in Q3 2024, indicating improved operational efficiency in production and sales.
Debt vs. Equity: How Amicus Therapeutics, Inc. (FOLD) Finances Its Growth
Debt vs. Equity: How Amicus Therapeutics, Inc. Finances Its Growth
The financial structure of Amicus Therapeutics, Inc. is characterized by a balance of debt and equity financing, which supports its growth strategies.
Overview of the Company's Debt Levels
As of September 30, 2024, the company reported total long-term debt of $389.5 million. The net carrying value of the debt was slightly higher than the previous quarter, which stood at $387.9 million. Short-term debt is minimal, primarily consisting of accrued liabilities and current portions of long-term debt.
Debt-to-Equity Ratio and Comparison to Industry Standards
Amicus Therapeutics has a debt-to-equity ratio of approximately 2.18, calculated from total liabilities of $389.5 million against total stockholders' equity of $178.8 million as of September 30, 2024. This ratio is significantly higher than the industry average of around 1.0, indicating a more aggressive leverage strategy compared to its peers.
Recent Debt Issuances, Credit Ratings, or Refinancing Activity
The company has not reported any recent new debt issuances or refinancing activities as of the last quarter. The interest expense for the three months ended September 30, 2024, was $12.7 million, reflecting ongoing interest obligations from its existing debt. The company's credit rating remains stable, although specific ratings have not been disclosed in recent reports.
How the Company Balances Between Debt Financing and Equity Funding
Amicus Therapeutics has utilized equity financing as a key component of its capital structure. In the nine months ended September 30, 2024, the company raised $19.2 million through its at-the-market equity program. This influx of equity capital is essential for funding ongoing research and development activities, which totaled $79.2 million during the same period. The company continues to balance its reliance on debt and equity, maintaining sufficient liquidity with cash, cash equivalents, and marketable securities of $249.8 million.
Financial Metric | Value |
---|---|
Total Long-term Debt | $389.5 million |
Debt-to-Equity Ratio | 2.18 |
Total Stockholders' Equity | $178.8 million |
Recent Equity Raised (9M 2024) | $19.2 million |
Cash, Cash Equivalents, and Marketable Securities | $249.8 million |
Interest Expense (Q3 2024) | $12.7 million |
Research and Development Expenses (9M 2024) | $79.2 million |
Assessing Amicus Therapeutics, Inc. (FOLD) Liquidity
Assessing Amicus Therapeutics' Liquidity
Current Ratio: As of September 30, 2024, the current ratio is calculated as follows:
Current Assets (in thousands) | Current Liabilities (in thousands) | Current Ratio |
---|---|---|
$408,274 | $158,138 | 2.58 |
Quick Ratio: The quick ratio, which excludes inventory from current assets, is:
Quick Assets (in thousands) | Current Liabilities (in thousands) | Quick Ratio |
---|---|---|
$291,436 | $158,138 | 1.84 |
Analysis of Working Capital Trends
As of September 30, 2024, the working capital position reflects:
Working Capital (in thousands) | Change from Previous Year |
---|---|
$250,136 | Improved from $200,585 in 2023 |
Cash Flow Statements Overview
For the nine months ended September 30, 2024, the cash flow components are as follows:
Cash Flow Type | 2024 (in thousands) | 2023 (in thousands) |
---|---|---|
Operating Activities | $(30,000) | $(72,549) |
Investing Activities | $19,832 | $122,021 |
Financing Activities | $4,024 | $53,467 |
Potential Liquidity Concerns or Strengths
As of September 30, 2024, the company holds:
- Cash and Cash Equivalents: $233,647,000
- Marketable Securities: $16,100,000
- Total Liquidity: $249,747,000
The accumulated deficit stands at $2,754,919,000 as of September 30, 2024, indicating ongoing financial strain despite a robust liquidity position.
Is Amicus Therapeutics, Inc. (FOLD) Overvalued or Undervalued?
Valuation Analysis
To assess the valuation of Amicus Therapeutics, Inc. (FOLD), we will examine key financial ratios, stock price trends, and analyst consensus.
Price-to-Earnings (P/E) Ratio
As of September 30, 2024, the company reported a net loss attributable to common stockholders of $70.845 million for the nine months ended September 30, 2024, resulting in a basic and diluted net loss per share of $0.23. Given that the company is currently unprofitable, the P/E ratio is not applicable.
Price-to-Book (P/B) Ratio
The total stockholders' equity as of September 30, 2024, was $178.825 million. The book value per share, calculated from the total stockholders' equity divided by the number of shares outstanding (298,691,094), is approximately $0.60.
With a current stock price of approximately $11.70 (based on the latest ATM offering price), the P/B ratio is calculated as follows:
P/B Ratio = Stock Price / Book Value per Share = $11.70 / $0.60 ≈ 19.5.
Enterprise Value-to-EBITDA (EV/EBITDA) Ratio
The enterprise value (EV) can be calculated as:
- Market Capitalization: $3.49 billion (based on stock price of $11.70 and shares outstanding)
- Total Debt: $389.494 million
- Cash and Cash Equivalents: $233.647 million
Thus, the EV is:
EV = Market Capitalization + Total Debt - Cash = $3.49 billion + $389.494 million - $233.647 million ≈ $3.645 billion.
The EBITDA for the last twelve months is not explicitly provided, but based on the net loss and operating expenses, we can estimate EBITDA as:
- Net Loss: $70.845 million
- Add back: Interest Expense: $37.640 million
- Add back: Depreciation and Amortization: $6.506 million
Estimating EBITDA = -$70.845 million + $37.640 million + $6.506 million = - $26.699 million. Since EBITDA is negative, the EV/EBITDA ratio is not applicable.
Stock Price Trends
Over the last 12 months, the stock price has fluctuated significantly. The stock reached a high of approximately $14.00 and a low of around $8.00. The current price of $11.70 indicates a moderate position within this range.
Dividend Yield and Payout Ratios
The company does not currently pay dividends, and therefore, the dividend yield is 0%.
Analyst Consensus on Stock Valuation
Analyst consensus indicates a rating of Hold for the stock, reflecting mixed sentiments about the company's future performance amidst ongoing losses and recent product launches.
Valuation Metric | Value |
---|---|
Price-to-Earnings (P/E) Ratio | N/A (Net Loss) |
Price-to-Book (P/B) Ratio | 19.5 |
Enterprise Value (EV) | $3.645 billion |
EBITDA | - $26.699 million |
Stock Price | $11.70 |
Dividend Yield | 0% |
Analyst Consensus | Hold |
Key Risks Facing Amicus Therapeutics, Inc. (FOLD)
Key Risks Facing Amicus Therapeutics, Inc.
Internal and External Risks:
Amicus Therapeutics faces significant risks related to industry competition, regulatory changes, and market conditions. The biotechnology sector is highly competitive, with numerous companies developing innovative treatments for rare diseases. As of September 30, 2024, the company reported an accumulated deficit of $2.8 billion, highlighting its ongoing financial challenges.
Operational Risks:
Operational risks are prominent, particularly concerning product development and commercialization. The launch of Pombiliti® + Opfolda® in 2024 has the potential to impact market share, but any delays or regulatory hurdles could adversely affect revenue. For the nine months ended September 30, 2024, net product sales reached $378.6 million, a significant increase from $284.3 million in the prior year.
Financial Risks:
Financial risks include ongoing losses and cash flow challenges. The net loss attributable to common stockholders for the nine months ended September 30, 2024, was $70.8 million, compared to $117.7 million for the same period in 2023. As of September 30, 2024, the company had cash, cash equivalents, and marketable securities totaling $249.8 million.
Strategic Risks:
Strategic risks involve the potential for unfavorable changes in regulatory environments and reimbursement landscapes. The company’s ability to commercialize its products effectively is contingent upon navigating these complex systems. The total liabilities as of September 30, 2024, stood at $607.7 million.
Mitigation Strategies:
Mitigation strategies include ongoing evaluation of business development opportunities and partnerships to enhance financial stability. The company has established an at-the-market (ATM) equity program with an aggregate offering gross proceeds of up to $250 million, with $164.7 million remaining available for issuance as of September 30, 2024.
Risk Category | Description | Financial Impact | Mitigation Strategy |
---|---|---|---|
Operational Risks | Delays in product launches and regulatory approvals | Potential loss of market share | Streamlining development processes |
Financial Risks | Ongoing operating losses | Net loss of $70.8 million in 2024 | ATM equity program to raise capital |
Strategic Risks | Regulatory changes affecting product approval | Impact on commercialization efforts | Engagement with regulatory authorities |
Market Risks | Intense competition in the biotechnology sector | Pressure on pricing and market share | Investment in R&D for innovative therapies |
The company’s financial health continues to be influenced by these multifaceted risks, necessitating vigilant management and strategic foresight to navigate the evolving landscape of the biotechnology industry.
Future Growth Prospects for Amicus Therapeutics, Inc. (FOLD)
Future Growth Prospects for Amicus Therapeutics, Inc. (FOLD)
Analysis of Key Growth Drivers
The primary growth drivers for Amicus Therapeutics include product innovations, market expansions, and strategic partnerships. The company has made significant strides with its lead products, Galafold® and Pombiliti® + Opfolda®, which are positioned to capture substantial market share in their respective therapeutic areas.
Product Innovations
Amicus Therapeutics has focused on developing innovative therapies for rare diseases. For the nine months ended September 30, 2024, net product sales reached $378.6 million, a significant increase from $284.3 million during the same period in 2023, reflecting a growth of 33.2%.
Galafold® revenue for the same period was $330.6 million, an increase of $49.4 million compared to the prior year. Meanwhile, Pombiliti® + Opfolda® generated $48.0 million in revenue since its launch, following approvals from major regulatory bodies.
Market Expansions
Amicus is expanding its geographical footprint, with plans to launch Galafold® in additional markets. As of September 30, 2024, the company had launched Pombiliti® + Opfolda® in the U.S., EU, and UK, with ongoing regulatory submissions in other regions. The total addressable market for these products is estimated to be significant, especially in Europe and North America, which are key regions for rare disease therapies.
Acquisitions and Strategic Initiatives
Amicus continues to explore strategic partnerships and acquisitions to bolster its product pipeline. The company is actively evaluating collaborations that can provide access to innovative technologies and enhance its competitive positioning. This approach is expected to drive future revenue growth through the introduction of new therapies and enhancements to existing products.
Future Revenue Growth Projections and Earnings Estimates
Analysts project that Amicus Therapeutics could see continued revenue growth, with estimates suggesting that total revenues could exceed $500 million by 2025, driven by the ongoing uptake of Galafold® and the recent launch of Pombiliti® + Opfolda®. This growth trajectory is contingent upon successful commercial execution and continued regulatory approvals.
Competitive Advantages
Amicus Therapeutics holds several competitive advantages, including:
- Established Product Portfolio: A proven track record with Galafold®, which has received regulatory approvals in over 40 countries.
- Innovative Treatment Paradigms: The unique mechanism of action of Pombiliti® + Opfolda® enhances the uptake of therapeutic enzymes, setting it apart from competitors.
- Strong Financial Position: As of September 30, 2024, the company reported cash and cash equivalents of $249.8 million, providing ample liquidity to support ongoing research and development efforts.
Financial Summary Table
Metrics | Q3 2024 | Q3 2023 | Change |
---|---|---|---|
Net Product Sales | $141.5 million | $103.5 million | $38.0 million |
Cost of Goods Sold | $13.3 million | $9.9 million | $3.4 million |
Research and Development Expenses | $26.2 million | $40.7 million | $(14.5 million) |
Selling, General, and Administrative Expenses | $75.1 million | $65.7 million | $9.5 million |
Net Loss | $(6.7 million) | $(21.6 million) | $14.8 million |
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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.