Group 1 - Amicus Therapeutics (NASDAQ: FOLD) is gaining momentum in the commercialization of its approved drug candidates, POMBILITI and OPFOLDA, aimed at treating patients with late-stage conditions [2] - The company is part of the Biotech Analysis Central service, which provides in-depth analysis of various pharmaceutical companies and includes a model portfolio of small and mid-cap stocks [2] Group 2 - The Biotech Analysis Central service offers a library of over 600 biotech investing articles and live chat features to assist healthcare investors in making informed decisions [2] - The subscription for the Biotech Analysis Central service is priced at $49 per month, with a yearly plan available at a discounted rate of $399, reflecting a 33.50% discount [1]

Core Insights - Amicus Therapeutics reported adjusted earnings of 1 cent per share for Q2 2025, missing the Zacks Consensus Estimate of 2 cents, compared to a loss of 6 cents per share in the same quarter last year [1][6] Financial Performance - Revenues for Q2 2025 totaled $154.7 million, representing a 22% year-over-year increase on a reported basis and an 18% increase at constant exchange rates, surpassing the Zacks Consensus Estimate of $148 million [2][6] - Galafold sales reached $128.9 million, up 12% year-over-year at constant exchange rates, although it fell short of the Zacks Consensus Estimate of $133 million [4][6] - Sales of the newly approved combination drug Pombiliti + Opfolda amounted to $25.8 million, exceeding both the Zacks Consensus Estimate of $24 million and the internal model estimate of $25 million [4][6] Growth Drivers - The revenue increase was attributed to higher sales from Galafold and additional revenues from Pombiliti + Opfolda, with ongoing studies aimed at expanding treatment labels for both Fabry and Pompe diseases [3][6] - The company maintained its 2025 revenue growth guidance of 15-22% at constant exchange rates, with Galafold expected to grow by 10-15% and Pombiliti + Opfolda by 50-65% [8] Operating Expenses and Cash Position - Adjusted operating expenses rose 56% to $127.8 million in Q2 2025, primarily due to a $30 million upfront payment for licensing rights to DMX-200 [7] - As of June 30, 2025, Amicus had cash, cash equivalents, and marketable securities totaling $231 million, down from $250.6 million as of March 31, 2025 [7] Future Outlook - The company expects to achieve positive GAAP net income in the second half of 2025 and aims to exceed $1 billion in total sales by 2028 [9] - Amicus has licensed exclusive rights for the commercialization of DMX-200, a potential first-in-class treatment for FSGS, with the pivotal phase III study on track for full enrollment by the end of 2025 [10]

PART I. FINANCIAL INFORMATION [Item 1. Consolidated Financial Statements and Notes (unaudited)](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20and%20Notes%20(unaudited)) This section provides unaudited consolidated financial statements, highlighting product sales growth, increased net loss for the quarter, and decreased cash [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to **$815.3 million** by June 30, 2025, while cash and equivalents decreased to **$158.7 million** Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $158,702 | $213,752 | | Total current assets | $538,007 | $504,736 | | Total Assets | $815,303 | $785,033 | | Total current liabilities | $167,647 | $148,702 | | Long-term debt | $391,322 | $390,111 | | Total Liabilities | $610,999 | $590,988 | | Total stockholders' equity | $204,304 | $194,045 | [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) Net product sales grew to **$154.7 million** in Q2 2025, but increased R&D expenses led to a **$24.4 million** net loss Quarterly Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net product sales | $154,688 | $126,669 | | Gross profit | $139,471 | $115,408 | | Research and development | $60,848 | $24,683 | | Selling, general, and administrative | $84,543 | $73,576 | | Loss from operations | $(9,474) | $14,967 | | Net loss | $(24,420) | $(15,697) | | Net loss per share | $(0.08) | $(0.05) | Six-Month Statement of Operations (in thousands, except per share data) | Metric | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net product sales | $279,937 | $237,072 | | Gross profit | $253,022 | $212,244 | | Research and development | $88,687 | $53,012 | | Selling, general, and administrative | $176,370 | $161,605 | | Loss from operations | $(17,426) | $(12,754) | | Net loss | $(46,106) | $(64,116) | | Net loss per share | $(0.15) | $(0.21) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to **$18.8 million** for H1 2025, resulting in a **$54.7 million** net cash decrease Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(18,768) | $(7,004) | | Net cash used in investing activities | $(38,639) | $(14,440) | | Net cash used in financing activities | $(12,100) | $(14,166) | | **Net decrease in cash** | **$(54,701)** | **$(37,720)** | | Cash at end of period | $162,015 | $212,357 | [Notes to Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail business operations, accounting policies, product revenue growth, and the **$30 million** Dimerix licensing agreement - The company markets Galafold® and Pombiliti® + Opfolda® for rare diseases, approved in major global markets[33](index=33&type=chunk) - An exclusive license agreement with Dimerix for DMX-200 involved a **$30 million** upfront payment and up to **$560 million** in potential milestones[33](index=33&type=chunk)[65](index=65&type=chunk) Net Product Sales by Product and Geography (in thousands) | Product/Region | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | **Total Galafold® sales** | **$128,872** | **$110,817** | **$233,116** | **$210,176** | | - Galafold® U.S. | $53,600 | $42,770 | $93,766 | $76,885 | | - Galafold® Ex-U.S. | $75,272 | $68,047 | $139,350 | $133,291 | | **Total Pombiliti® + Opfolda® sales** | **$25,816** | **$15,852** | **$46,821** | **$26,896** | | - Pombiliti® + Opfolda® U.S. | $10,730 | $7,368 | $20,557 | $10,628 | | - Pombiliti® + Opfolda® Ex-U.S. | $15,086 | $8,484 | $26,264 | $16,268 | | **Total net product sales** | **$154,688** | **$126,669** | **$279,937** | **$237,072** | - Inventories increased to **$154.9 million** by June 30, 2025, from **$118.8 million** at year-end 2024, supporting commercial growth[62](index=62&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, strategic progress, and liquidity, highlighting commercial growth and the DMX-200 licensing deal [Overview and Strategy](index=21&type=section&id=Overview%20and%20Strategy) The company's strategy focuses on developing and commercializing rare disease therapies, expanding its pipeline with DMX-200 - The company's strategy involves developing and delivering high-quality rare disease medicines through various means[82](index=82&type=chunk) - Pipeline advancement includes licensing exclusive U.S. commercialization rights for DMX-200, a Phase 3 candidate for FSGS[81](index=81&type=chunk)[88](index=88&type=chunk) - Continued focus remains on Fabry and Pompe disease franchises, with ongoing discovery for next-generation therapies[82](index=82&type=chunk)[90](index=90&type=chunk) [Consolidated Results of Operations](index=23&type=section&id=Consolidated%20Results%20of%20Operations) Q2 2025 net product sales increased **22%** to **$154.7 million**, while R&D expenses surged due to a **$30.0 million** license payment Q2 2025 vs Q2 2024 Financial Comparison (in thousands) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $154,688 | $126,669 | $28,019 | | Research and development | $60,848 | $24,683 | $36,165 | | Selling, general, and administrative | $84,543 | $73,576 | $10,967 | | Net loss | $(24,420) | $(15,697) | $(8,723) | - The **$36.2 million** increase in Q2 R&D costs was primarily due to the **$30.0 million** upfront Dimerix license payment[93](index=93&type=chunk) H1 2025 vs H1 2024 Financial Comparison (in thousands) | Metric | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | | Net product sales | $279,937 | $237,072 | $42,865 | | Research and development | $88,687 | $53,012 | $35,675 | | Selling, general, and administrative | $176,370 | $161,605 | $14,765 | | Net loss | $(46,106) | $(64,116) | $18,010 | [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company held **$231.0 million** in cash and equivalents, with **$18.8 million** net cash used in operations for H1 2025 - Total cash, cash equivalents, and marketable securities amounted to **$231.0 million** as of June 30, 2025[88](index=88&type=chunk)[102](index=102&type=chunk) - Net cash used in operations for H1 2025 was **$18.8 million**, reflecting net loss and increased inventory[103](index=103&type=chunk) - An at-the-market (ATM) equity program has **$164.2 million** remaining capacity as of June 30, 2025[101](index=101&type=chunk) - Management believes current cash is sufficient to fund operations and research programs for at least the next 12 months[110](index=110&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) No material changes to market risks or their management have occurred since December 31, 2024 - No material changes to the company's market risks have occurred since December 31, 2024[115](index=115&type=chunk) [Item 4. Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Disclosure controls and procedures were concluded effective by key officers as of the reporting period end[116](index=116&type=chunk) - No material changes to internal control over financial reporting occurred during the last fiscal quarter[117](index=117&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in Hatch-Waxman litigation for Galafold®, settling with Teva while continuing cases against others - Litigation is ongoing against Teva, Aurobindo, and Lupin concerning generic Galafold® ANDA filings[118](index=118&type=chunk) - A settlement with Teva grants a generic Galafold® license in the U.S. starting January 30, 2037, resolving their litigation[119](index=119&type=chunk) - Litigation remains active against Aurobindo, with a stay in place for the Lupin case[119](index=119&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors were reported compared to the prior Annual Report on Form 10-K - No material changes to risk factors were reported compared to the Annual Report on Form 10-K for fiscal year 2024[120](index=120&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred, but **28,748** shares were purchased to cover tax obligations - No unregistered sales of equity securities occurred during the period[121](index=121&type=chunk) Issuer Purchases of Equity Securities (Q2 2025) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April 2025 | 4,374 | $6.92 | | May 2025 | 16,494 | $6.31 | | June 2025 | 7,880 | $6.04 | | **Total** | **28,748** | **$6.33** | - Purchased shares represent common stock withheld to satisfy taxes from restricted stock unit vesting[122](index=122&type=chunk) [Item 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangement changes occurred, and the Cash Deferral Plan was frozen by the Board - No director or officer adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter[125](index=125&type=chunk) - The Board of Directors froze the company's Cash Deferral Plan on July 29, 2025, preventing new deferrals[126](index=126&type=chunk) [Item 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including the Equity Incentive Plan and Dimerix license agreement - Key exhibits include the 2025 Equity Incentive Plan, loan agreement amendments, and the Dimerix Biosciences license agreement[128](index=128&type=chunk)

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 reached $154.7 million, a 22% increase compared to Q2 2024, with an 18% growth at constant exchange rates [24] - Galafold revenue was $128.9 million, up 12% at constant exchange rates and 16% in reported terms [10] - Non-GAAP net income for Q2 2025 was $1.9 million, compared to $18.5 million in Q2 2024 [26] Business Line Data and Key Metrics Changes - Galafold saw a 13% year-over-year patient growth, with over 69% global market share for treated Fabry patients with amenable mutations [6][10] - Pombility and Upholda revenue reached $25.8 million, up 58% at constant exchange rates, with the U.S. contributing approximately 42% of revenue [14][15] - The company expects Pombility and Upholda to achieve a combined revenue growth of 50% to 65% for 2025 at constant exchange rates [16] Market Data and Key Metrics Changes - The U.S. market remains a significant driver, with over 1,000 patient starts for Galafold since launch [11] - The company launched Pombility and Upholda in six new countries in Q2 2025, expanding its market presence [18] - The untreated population for Fabry disease is estimated to be significantly larger than previously believed, indicating substantial market opportunity [13] Company Strategy and Development Direction - The company aims to achieve GAAP profitability in the second half of 2025, maintaining financial discipline while expanding its product portfolio [9] - Strategic partnerships, such as with Dimerix for DMX200, are key to addressing unmet needs in rare diseases [7][21] - The company is focused on expanding into new markets and increasing patient access, with plans for further geographic expansion in 2026 [85] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for the remainder of 2025, citing strong demand for Galafold and the potential of Pombility and Upholda [5][6] - The company highlighted the importance of real-world evidence in driving physician and patient adoption of its therapies [33] - Management remains optimistic about the long-term potential of its products, particularly in underdiagnosed populations [13] Other Important Information - The company reiterated its full-year financial guidance for 2025, expecting total revenue growth of 15% to 22% [27] - Cash, cash equivalents, and marketable securities were $231 million as of June 30, 2025, down from $250 million at the end of 2024 [26] Q&A Session Summary Question: What clinical assessments resonate with physicians and KOLs for switching from Nexviazyme to Pombility? - Management indicated that physicians look for stability or improvement in patient outcomes, including biomarkers and quality of life measures [32][34] Question: Update on the additional manufacturing facility in Ireland? - The company expects the Irish facility to come online in the latter half of 2025, which will help meet global demand [38][40] Question: Confidence in IP position and potential for settlement? - Management remains confident in the strength of its IP and the potential for favorable settlements, reinforced by previous agreements [46][48] Question: Timelines for the new U.S. manufacturing process and impacts on COGS? - The U.S. drug product manufacturing facility is progressing, with timelines not yet specified, but the company is optimistic about its overall manufacturing strategy [52][54] Question: Insights on patient starts in ex-U.S. markets? - The company reported strong market share growth in the UK and Germany, with ongoing launches in new countries [62][64] Question: Drivers for patient switches at the two-year mark? - Management noted that switches are influenced by patient outcomes and physician assessments, with a focus on proactive treatment strategies [68][70] Question: Regulatory alignment with the FDA on proteinuria for DMX200? - The FDA has indicated that proteinuria can serve as a primary endpoint, which is a positive development for the program [74][80]

Company Performance - Amicus Therapeutics reported quarterly earnings of $0.01 per share, missing the Zacks Consensus Estimate of $0.02 per share, and down from $0.06 per share a year ago, representing an earnings surprise of -50.00% [1] - The company posted revenues of $154.69 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 4.87%, compared to year-ago revenues of $126.67 million [2] - Over the last four quarters, Amicus Therapeutics has surpassed consensus EPS estimates just once and topped consensus revenue estimates two times [2] Stock Performance - Amicus Therapeutics shares have lost about 34.9% since the beginning of the year, while the S&P 500 has gained 8.2% [3] - The current status of estimate revisions translates into a Zacks Rank 4 (Sell) for the stock, indicating expected underperformance in the near future [6] Future Outlook - The current consensus EPS estimate for the coming quarter is $0.11 on revenues of $164.66 million, and $0.32 on revenues of $621.22 million for the current fiscal year [7] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the bottom 41% of over 250 Zacks industries, which may impact stock performance [8]

Financial Performance - Q2 2025 total revenue reached $154.7 million, an 18% increase at CER (Constant Exchange Rates)[61] - Non-GAAP net income for Q2 2025 was $1.9 million[61] - The company expects to surpass $1 billion in total revenue in FY 2028[6] - The company reiterates FY 2025 total revenue growth guidance of 15% to 22% at CER[65,67] Product Performance - Galafold Q2 2025 revenue was $128.9 million, a 16% increase in reported sales growth[10] - The company anticipates Galafold revenue growth of 10% to 15% for FY 2025 at CER[4,65,67] - Pombiliti + Opfolda Q2 2025 revenue was $25.8 million, a 58% increase at CER[22] - The company anticipates Pombiliti + Opfolda revenue growth of 50% to 65% for FY 2025 at CER[5,25,65,67] Strategic Initiatives - The company acquired U S licensing of DMX-200 Phase 3 Program[4] - The company aims to deliver positive GAAP net income during H2 2025[65,67]

[Q2 2025 Financial Results and Corporate Updates](index=1&type=section&id=Amicus%20Therapeutics%20Announces%20Second%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Updates) Amicus Therapeutics reports strong Q2 2025 financial results and significant corporate advancements [Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Amicus reported strong Q2 2025 total revenue growth, driven by product sales, despite a widened GAAP net loss due to increased operating expenses Q2 2025 Revenue Performance (YoY) | Product | Q2 2025 Revenue (in millions) | Q2 2024 Revenue (in millions) | Reported Growth | Growth at CER | | :--- | :--- | :--- | :--- | :--- | | **Total Net Product Revenues** | **$154.7** | **$126.7** | **22%** | **18%** | | Galafold | $128.9 | $110.8 | 16% | 12% | | Pombiliti + Opfolda | $25.8 | $15.9 | 63% | 58% | Q2 2025 Profitability Metrics | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | | :--- | :--- | :--- | | GAAP Net Loss | ($24.4) | ($15.7) | | GAAP Loss Per Share | ($0.08) | ($0.05) | | Non-GAAP Net Income | $1.9 | $18.5 | | Non-GAAP Income Per Share | $0.01 | $0.06 | - Total GAAP operating expenses increased by **48% to $148.9 million**, and non-GAAP operating expenses rose **56% to $127.8 million**. Both figures include the **$30 million** upfront payment for the U.S. licensing agreement of DMX-200[4](index=4&type=chunk) [Business and Operational Highlights](index=1&type=section&id=Corporate%20Updates) The company anticipates exceeding $1 billion in revenue by 2028, with key regulatory approvals and clinical trial progress - The company is positioned to achieve GAAP profitability in the second half of 2025 and anticipates exceeding **$1 billion** in total revenue in 2028[2](index=2&type=chunk) - Pombiliti + Opfolda received regulatory approval in Japan for adult LOPD patients and the company is on track for launches in up to **10 new countries** in 2025[13](index=13&type=chunk) - The ACTION3 Phase 3 study of DMX-200, a treatment for the rare kidney disease FSGS, is on track for full enrollment by the end of the year. Amicus acquired exclusive U.S. commercialization rights from Dimerix[2](index=2&type=chunk)[13](index=13&type=chunk) [2025 Financial Guidance](index=3&type=section&id=2025%20Financial%20Guidance) Amicus reiterates full-year 2025 financial guidance, projecting continued revenue growth and GAAP profitability in H2 2025 Full-Year 2025 Guidance | Metric | Guidance | | :--- | :--- | | Total Revenue Growth | 15% to 22% | | Galafold Revenue Growth | 10% to 15% | | Pombiliti + Opfolda Revenue Growth | 50% to 65% | | Gross Margin | Mid 80% | | Non-GAAP Operating Expenses | $380M to $400M | | GAAP Net Income | Positive during H2 2025 | [Financial Position](index=3&type=section&id=Financial%20Position) Amicus maintained a solid financial position with $231.0 million in cash, reflecting strategic investments in DMX-200 licensing - Cash, cash equivalents, and marketable securities totaled **$231.0 million** at June 30, 2025. The current cash position reflects the **$30 million** upfront payment made in Q2 for the U.S. licensing of DMX-200[6](index=6&type=chunk) Key Balance Sheet Items (as of June 30, 2025) | Account | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $158.7 | $213.8 | | Total current assets | $538.0 | $504.7 | | Total Assets | $815.3 | $785.0 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $167.6 | $148.7 | | Long-term debt | $391.3 | $390.1 | | Total liabilities | $611.0 | $591.0 | | Total stockholders' equity | $204.3 | $194.0 | | Total Liabilities and Stockholders' Equity | $815.3 | $785.0 | [Product Portfolio Overview](index=4&type=section&id=Product%20Portfolio%20Overview) Overview of Amicus Therapeutics' key product offerings, Galafold and Pombiliti + Opfolda, detailing their indications and mechanisms [Galafold](index=4&type=section&id=About%20Galafold) Galafold is an oral pharmacological chaperone for adults with Fabry disease, approved globally for amenable GLA gene variants - Indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant[15](index=15&type=chunk) - The most common adverse reactions (≥10%) include headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia[16](index=16&type=chunk) [Pombiliti + Opfolda](index=5&type=section&id=About%20Pombiliti%20%2B%20Opfolda) Pombiliti + Opfolda is a two-component therapy for adult late-onset Pompe disease patients not improving on current ERT - Indicated for adult patients with late-onset Pompe disease (weighing ≥40 kg) who are not improving on their current enzyme replacement therapy (ERT)[18](index=18&type=chunk) - The therapy carries a boxed warning for hypersensitivity reactions, infusion-associated reactions (IARs), and risk of acute cardiorespiratory failure in susceptible patients. It is contraindicated in pregnancy[19](index=19&type=chunk) [Appendix: Detailed Financial Statements](index=10&type=section&id=Appendix%3A%20Detailed%20Financial%20Statements) Comprehensive financial statements including consolidated operations, balance sheets, and non-GAAP reconciliations for Q2 2025 [Consolidated Statements of Operations](index=10&type=section&id=TABLE%201%20Amicus%20Therapeutics%2C%20Inc.%20Consolidated%20Statements%20of%20Operations) Summary of Amicus Therapeutics' unaudited consolidated statements of operations for the three and six months ended June 30, 2025 Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Net product sales | $154,688 | $126,669 | $279,937 | $237,072 | | Gross profit | $139,471 | $115,408 | $253,022 | $212,244 | | Total operating expenses | $148,945 | $100,441 | $270,448 | $224,998 | | Loss from operations | ($9,474) | $14,967 | ($17,426) | ($12,754) | | Net loss attributable to common stockholders | ($24,420) | ($15,697) | ($46,106) | ($64,116) | | Net loss per share — basic and diluted | ($0.08) | ($0.05) | ($0.15) | ($0.21) | [Consolidated Balance Sheets](index=11&type=section&id=TABLE%202%20Amicus%20Therapeutics%2C%20Inc.%20Consolidated%20Balance%20Sheets) Overview of Amicus Therapeutics' unaudited consolidated balance sheets as of June 30, 2025, and December 31, 2024 Consolidated Balance Sheets (Unaudited, in thousands) | | **June 30, 2025** | **December 31, 2024** | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $158,702 | $213,752 | | Total current assets | $538,007 | $504,736 | | Total Assets | $815,303 | $785,033 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $167,647 | $148,702 | | Long-term debt | $391,322 | $390,111 | | Total liabilities | $610,999 | $590,988 | | Total stockholders' equity | $204,304 | $194,045 | | Total Liabilities and Stockholders' Equity | $815,303 | $785,033 | [Reconciliation of Non-GAAP Financial Measures](index=12&type=section&id=TABLE%203%20Amicus%20Therapeutics%2C%20Inc.%20Reconciliation%20of%20Non-GAAP%20Financial%20Measures) Reconciliation of GAAP to Non-GAAP financial measures, including operating expenses and net income, for Q2 2025 Reconciliation of GAAP to Non-GAAP Operating Expenses (Unaudited, in thousands) | | **Three Months Ended June 30, 2025** | **Three Months Ended June 30, 2024** | | :--- | :--- | :--- | | Total operating expenses - as reported GAAP | $148,945 | $100,441 | | Total operating expense adjustments to reported GAAP | $21,113 | $18,379 | | Total operating expenses - as adjusted (Non-GAAP) | $127,832 | $82,062 | Reconciliation of GAAP Net Loss to Non-GAAP Net Income (Unaudited, in thousands) | | **Three Months Ended June 30, 2025** | **Three Months Ended June 30, 2024** | | :--- | :--- | :--- | | GAAP net loss | ($24,420) | ($15,697) | | Adjustments (Share-based comp, D&A, etc.) | $26,352 | $34,184 | | Non-GAAP net income | $1,932 | $18,487 |

Pombiliti + Opfolda Q2 Revenue of $25.8M, up 58% at CER Reiterating 2025 Financial Guidance including GAAP Profitability During H2 2025 Conference Call and Webcast Today at 8:30 a.m. ET PRINCETON, N.J., July 31, 2025 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a patient- dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced financial results for the quarter ended June 30, 2025. "We delivered strong second quarter growt ...

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Core Viewpoint - The market anticipates a year-over-year decline in earnings for Amicus Therapeutics despite higher revenues, with the actual results being crucial for stock price movement [1][2]. Earnings Expectations - Amicus Therapeutics is expected to report earnings of $0.02 per share, reflecting a year-over-year decrease of 66.7%, while revenues are projected to be $147.5 million, an increase of 16.4% from the previous year [3]. - The earnings report is scheduled for July 31, and better-than-expected results could lead to a stock price increase, whereas disappointing results may cause a decline [2]. Estimate Revisions - The consensus EPS estimate has been revised 10% higher in the last 30 days, indicating a collective reassessment by analysts [4]. - The Most Accurate Estimate for Amicus Therapeutics is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +191.67%, although the stock has a Zacks Rank of 4, complicating predictions of an earnings beat [12]. Earnings Surprise History - In the last reported quarter, Amicus Therapeutics was expected to post earnings of $0.08 per share but only achieved $0.03, resulting in a surprise of -62.50% [13]. - Over the past four quarters, the company has surpassed consensus EPS estimates twice [14]. Industry Comparison - NeoGenomics, another company in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings of $0.03 per share, unchanged from the previous year, with revenues projected at $182.93 million, up 11.2% [18]. - NeoGenomics has an Earnings ESP of -22.22% and a Zacks Rank of 2, making it difficult to predict an earnings beat despite a history of surpassing estimates [19][20].