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Amicus Therapeutics, Inc. (FOLD)

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  • GlobeNewswire

    Amicus Therapeutics Receives European Medicines Agency PRIME Designation for CLN6 Batten Disease Gene Therapy

    Additional Phase 1/2 Data to be Presented at the Child Neurology Society Annual Meeting in OctoberCRANBURY, N.J., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today announced the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to AT-GTX-501, the Company’s investigational gene therapy for children living with variant late infantile neuronal ceroid lipofuscinosis 6 (vLINCL6) disease, also known as CLN6 Batten disease. The PRIME initiative provides enhanced support and increased interaction to developers of promising medicines with the goal of optimizing development plans and speeding regulatory evaluations. The goal of EMA’s PRIME is to help patients benefit as early as possible from innovative new therapies that have demonstrated the potential to significantly address an unmet medical need.The PRIME designation is based on data from the ongoing Phase 1/2 clinical trial evaluating a single dose of AT-GTX-501 for the treatment of children with CLN6 Batten disease. Additional information about the trial is available at ClinicalTrials.gov (NCT02725580).“We are very pleased that the EMA has recognized the potential of our CLN6 gene therapy. Based on our preliminary clinical data, we believe AT-GTX-501 could potentially be a transformative treatment option for children living with CLN6 Batten disease, an ultra-rare, debilitating condition that presents in early childhood and is often associated with childhood death,” said John F. Crowley, Chairman and Chief Executive Officer. “We look forward to continuing to work closely with the EMA to accelerate development of this first potential treatment option for children living with CLN6 Batten disease.”Additional data from the ongoing Phase 1/2 clinical study will be presented at the Child Neurology Society Annual Meeting in October. Regulatory interactions are ongoing and the Company expects to provide feedback on the path forward in early 2021.In the U.S., AT-GTX-501 previously was granted Rare Pediatric Disease and Orphan Drug designations by the United States Food and Drug Administration. In the EU, the Company now holds PRIME and orphan medicinal product designations.About AT-GTX-501 AT-GTX-501 is a novel gene therapy in Phase 1/2 development for CLN6 Batten disease, a rare, fatal, inherited lysosomal disorder with no approved treatment that primarily affects the nervous system. AT-GTX-501 is dosed in a one-time intrathecal infusion to deliver a functional copy of the CLN6 gene to cells of the central nervous system. The therapy is designed to address the underlying enzyme deficiency that results in progressive cell damage and neurodevelopmental and physical decline.About Batten Disease Batten disease is the common name for a broad class of rare, fatal, inherited disorders of the nervous system also known as neuronal ceroid lipofuscinoses, or NCLs. In these disorders, a defect in a specific gene triggers a cascade of problems that interferes with a cell’s ability to recycle certain molecules. Each gene is called CLN (ceroid lipofuscinosis, neuronal) and given a different number designation as its subtype. There are 13 known forms of Batten disease often referred to as CLN1-8; 10-14. The various types of Batten disease have similar features and symptoms but vary in severity and age of onset.Most forms of Batten disease/NCLs usually begin during childhood. The clinical course often involves progressive loss of independent adaptive skills such as mobility, feeding and communication. Patients may also experience vision loss, personality changes, behavioral problems, learning impairment and seizures. Patients typically experience progressive loss of motor function and eventually become wheelchair-bound, are then bedridden and die prematurely.About Amicus Therapeutics Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on Twitter and LinkedIn.Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials and the prospects and timing of the potential regulatory approval of our product candidates. In particular, this press release relates to interim data from an ongoing Phase 1/2 study to investigate intrathecal administration of AAV-CLN6 gene therapy. The inclusion of forward-looking statements arising from this interim data, ongoing study and natural history preliminary data should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, and in particular the potential goals, progress, timing, and results of preclinical studies and clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; and the potential that we will need additional funding to complete all of our studies. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. The interim data and Phase 1/2 study discussed herein is inherently preliminary and early in the study, derived from a limited patient set, and later trial results with this patient set or others may not be consistent with these preliminary results. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.CONTACTS:Investors: Amicus Therapeutics Andrew Faughnan Director, Investor Relations afaughnan@amicusrx.com (609) 662-3809Media: Amicus Therapeutics Diana Moore Head of Global Corporate Communications dmoore@amicusrx.com (609) 662-5079FOLD–G

  • GlobeNewswire

    Amicus Therapeutics to Present at Upcoming Investor Conferences in September 2020

    CRANBURY, N.J., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that members of the Amicus senior leadership team will participate in upcoming presentations at the following virtual investor conferences in September: * Citi’s 15th Annual BioPharma Virtual Conference on Thursday, September 10, 2020 at 8:55 a.m. E.T. * Cantor Virtual Global Healthcare Conference on Wednesday, September 16, 2020 at 10:00 a.m. E.T. * Bank of America Global Healthcare Conference on Friday, September 18, 2020 at 4:45 p.m. B.S.T. (11:45 a.m. E.T.)A live audio webcast of each presentation can be accessed via the Investors section of the Amicus Therapeutics corporate website at https://ir.amicusrx.com/events-and-presentations.About Amicus Therapeutics Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on Twitter and LinkedIn.CONTACT: Investors: Amicus Therapeutics Andrew Faughnan Director, Investor Relations afaughnan@amicusrx.com (609) 662-3809Media: Amicus Therapeutics Diana Moore Head of Global Corporate Communications dmoore@amicusrx.com (609) 662-5079FOLD–G

  • GlobeNewswire

    Amicus Therapeutics Announces Second Quarter 2020 Financial Results and Corporate Updates

    Galafold 2Q2020 Revenue of $62.4 Million, On-Track to Achieve 2020 Revenue Guidance of  $250M-$260MAT-GAA Phase 3 PROPEL Study Readout and Rolling BLA Submission to U.S. FDA on ScheduleAdvancing Industry-Leading Rare Disease Gene Therapy PortfolioPath to Profitability Achieved without the Need for Any Future Dilutive FinancingsConference Call and Webcast Today at 8:30 a.m. ETCRANBURY, N.J. , Aug. 10, 2020 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD), a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel medicines for rare diseases, today announced financial results for the second quarter ended June 30, 2020. The Company also summarized recent program updates and reiterated its full-year 2020 guidance.John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics, Inc., stated, “During the second quarter, we made tremendous progress advancing our mission for patients and are on track to achieve our 2020 key strategic priorities, including our global Fabry launch, Pompe late-stage development program, and advancing our industry-leading gene therapy pipeline. Following our strategic financing in July, Amicus is firmly on a path to profitability without the need to access the equity markets. Through these efforts, we remain strongly positioned to achieve our vision of delivering groundbreaking new medicines and hopefully, one day, cures for people living with rare diseases.”Corporate Highlights * Global revenue for Galafold® (migalastat) in the second quarter of 2020 was $62.4M. Second quarter revenue represented a year-over-year increase of 41% from total revenue of $44.1 million in the second quarter of 2019. On a constant currency basis, second quarter 2020 total revenue was $63.3 million, representing operational revenue growth measured at constant currency exchange rates of 43%, which was offset by a negative currency impact of $1.0 million, or 2%. * Strong second quarter revenue represents the continued performance across the global business, including new patient starts from switch and naïve patients throughout the quarter in all major regions, including that hardest hit by COVID-19. Performance driven largely by strong patient demand. Global compliance and adherence rates continue to exceed 90%. * 1,000+ mutations added to the EU Galafold label.  This update includes a number of new mutations identified by creating and testing all possible single-base pair point mutations in the GLA gene. Including this list will help physicians assess treatment options in an expeditious manner.  Amenable mutations continue to represent up to half of all people living with Fabry disease. * Global Phase 3 PROPEL clinical study of AT-GAA in late-onset Pompe disease (LOPD) remains on track for top line data in 1H21. To date, 97%+ of the 2,810 planned infusions and assessments for the ongoing PROPEL study have been completed on schedule. The Company plans to initiate a rolling BLA for AT-GAA in the second half of 2020, completing final submission in the first half of 2021. * Expanded Access Program for infantile-onset Pompe patients underway. Amicus has initiated an expanded access program for its investigational medicine AT-GAA for young children living with infantile-onset Pompe disease (IOPD). * Additional Phase 1/2 CLN6 data to be presented this year at the Child Neurology Society Annual Meeting in October. Regulatory interactions are ongoing and the Company expects to provide feedback on the path forward in early 2021. * Initial data from the Phase 1/2 CLN3 study expected in early 2021 based on changes in medical conference schedules. Regulatory interactions are ongoing and concurrent with the data, the Company expects to provide feedback on the regulatory pathway. * Positive preclinical Pompe gene therapy data presented at American Society of Cell and Gene Therapy meeting in May. Positive results showed the Amicus engineered hGAA having better targeting and clearance of glycogen storage in Pompe mice. Preliminary data in non-human primates suggested therapeutically relevant expression levels in target organs. * Cash position sufficient to achieve self-sustainability without the need for any future dilutive financings. The previously announced debt facility places Amicus firmly on a path to profitability, while the Company continues to carefully manage expenses and investments, while executing on the Galafold launch and advancing development programs. 2020 Key Strategic Priorities * Achieve $250 million to $260 million of global product revenue for Galafold * Complete Pompe Phase 3 PROPEL study, enroll pediatric studies and advance manufacturing to support 2021 BLA and MAA * Advance clinical development, manufacturing and regulatory discussions for CLN6 and CLN3 Batten programs * Progress Pompe gene therapy towards Investigational New Drug (IND) application and disclose up to two additional IND candidates * Maintain strong financial positionSecond Quarter 2020 Financial Results * Total revenue in the second quarter 2020 was $62.4 million, a year-over-year increase of 41% from total revenue of $44.1 million in the second quarter of 2019. On a constant currency basis, second quarter 2020 total revenue was $63.3 million, representing operational revenue growth measured at constant currency exchange rates of 43%, which was offset by a negative currency impact of $1.0 million, or 2%. * Cash, cash equivalents, and marketable securities totaled $309.6 million at June 30, 2020, compared to $452.7 million at December 31, 2019. * Total GAAP operating expenses of $107.0 million for the second quarter 2020 decreased as compared to $115.2 million for the second quarter 2019, reflecting decreased travel and third-party costs, offset by continued investments in our gene therapy pipeline. * Total non-GAAP operating expenses of $95.9 million for the second quarter of 2020 decreased as compared to $103.6 million in the second quarter of 2019, reflecting decreased travel and third-party costs, offset by continued investments in our gene therapy pipeline.1 * Net loss was $52.5 million, or $0.20 per share, compared to a net loss of $84.6 million, or $0.36 per share, for the second quarter 2019.1 Full reconciliation of GAAP results to the Company’s non-GAAP adjusted measures for all reporting periods appear in the tables to this press release.2020 Financial Guidance * For the full-year 2020, the Company anticipates total Galafold revenue of $250 million to $260 million based on the average exchange rates for 2019. * Non-GAAP operating expense guidance for the full-year 2020 is $410 million to $420 million, driven by continued investment in the global Galafold launch, AT-GAA clinical studies, and advancing our gene therapy pipeline.2 * Cash, cash equivalents, and marketable securities totaled $309.6 million at June 30, 2020. Based on current operating models, the Company believes that the current cash position, along with the net proceeds from the 2020 Senior Secured Term Loan and expected revenues, is sufficient to fund the Company’s operations and ongoing research programs through to profitability.2 A reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure is not available without unreasonable effort due to high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure. Anticipated 2020 Milestones by ProgramGalafold (migalastat) Oral Precision Medicine for Fabry Disease * On track to meet full-year 2020 revenue guidance range of $250 million to $260 million * Continued geographic expansion * Registry and other Phase 4 studies underwayAT-GAA for Pompe Disease * Plans to initiate a Rolling Biologics License Application (BLA) for AT-GAA in 2020, with addition of complete clinical results for PROPEL in 1H2021 to support full approval * Retrospective natural history study data in approximately 100 Pompe Patients treated with enzyme replacement therapy * Additional supportive studies, including an open-label study in 12- to <18-year-olds living with PompeGene Therapy Portfolio * Report further safety and efficacy data in the CLN6 Batten disease Phase 1/2 study and advance regulatory discussions to finalize clinical and regulatory path * Initial data from the CLN3 Batten disease Phase 1/2 study expected in early 2021 and advance regulatory discussions to finalize clinical and regulatory path * Continue IND-enabling toxicology work in Pompe disease and progress towards IND * Additional preclinical data expected across multiple programs with disclosure of up to two additional IND candidates * Manufacturing advancements across portfolio          Conference Call and Webcast Amicus Therapeutics will host a conference call and audio webcast today, August 10, 2020 at 8:30 a.m. ET to discuss the second quarter 2020 financial results and corporate updates. Interested participants and investors may access the conference call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784 (international), conference ID: 4949075.A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call.  A replay of the call will be available for seven days beginning at 11:30 a.m. ET on August 10, 2020. Access numbers for this replay are 855-859-2056 (U.S./Canada) and 404-537-3406 (international); conference ID: 4949075.About Galafold  Galafold® (migalastat) 123 mg capsules is an oral pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A) for the treatment of Fabry disease in adults who have amenable GLA variants. In these patients, Galafold works by stabilizing the body’s own dysfunctional enzyme so that it can clear the accumulation of disease substrate. Globally, Amicus Therapeutics estimates that approximately 35 to 50 percent of Fabry patients may have amenable GLA variants, though amenability rates within this range vary by geography. Galafold is approved in over 40 countries around the world, including the U.S., EU, U.K., Japan and others.U.S. INDICATIONS AND USAGE Galafold is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.U.S. IMPORTANT SAFETY INFORMATIONADVERSE REACTIONS The most common adverse reactions reported with Galafold (≥10%) were headache, nasopharyngitis, urinary tract infection, nausea and pyrexia.USE IN SPECIFIC POPULATIONS There is insufficient clinical data on Galafold use in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. Advise women of the potential risk to a fetus.It is not known if Galafold is present in human milk. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Galafold and any potential adverse effects on the breastfed child from Galafold or from the underlying maternal condition.Galafold is not recommended for use in patients with severe renal impairment or end-stage renal disease requiring dialysis.The safety and effectiveness of Galafold have not been established in pediatric patients.To report Suspected Adverse Reactions, contact Amicus Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.For additional information about Galafold, including the full U.S. Prescribing Information, please visit https://www.amicusrx.com/pi/Galafold.pdf.EU Important Safety Information Treatment with Galafold should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. Galafold is not recommended for use in patients with a nonamenable mutation. * Galafold is not intended for concomitant use with enzyme replacement therapy. * Galafold is not recommended for use in patients with Fabry disease who have severe renal impairment (<30 mL/min/1.73 m2). The safety and efficacy of Galafold in children 0–15 years of age have not yet been established. * No dosage adjustments are required in patients with hepatic impairment or in the elderly population. * There is very limited experience with the use of this medicine in pregnant women. If you are pregnant, think you may be pregnant, or are planning to have a baby, do not take this medicine until you have checked with your doctor, pharmacist, or nurse. * While taking Galafold, effective birth control should be used. It is not known whether Galafold is excreted in human milk. * Contraindications to Galafold include hypersensitivity to the active substance or to any of the excipients listed in the PRESCRIBING INFORMATION. * It is advised to periodically monitor renal function, echocardiographic parameters and biochemical markers (every 6 months) in patients initiated on Galafold or switched to Galafold. * OVERDOSE: General medical care is recommended in the case of Galafold overdose. * The most common adverse reaction reported was headache, which was experienced by approximately 10% of patients who received Galafold. For a complete list of adverse reactions, please review the SUMMARY OF PRODUCT CHARACTERISTICS. * Call your doctor for medical advice about side effects.   For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu.About Amicus Therapeutics Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases. For more information please visit the company’s website at www.amicusrx.com, and follow on Twitter and LinkedIn.Non-GAAP Financial Measures In addition to financial information prepared in accordance with U.S. GAAP, this press release also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. Full reconciliations of GAAP results to the comparable non-GAAP measures for the reported periods appear in the financial tables section of this press release. When we provide our expectation for non-GAAP operating expenses on a forward-looking basis, a reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure generally is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure in the relevant future period, such as unusual gains or losses. The variability of the excluded items may have a significant, and potentially unpredictable, impact on our future GAAP results.Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, manufacturing and supply plans, financing plans, and the projected revenues and cash position for the Company. The inclusion of forward-looking statements should not be regarded as a representation by us that any of our plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong and can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing, and outcomes of discussions with regulatory authorities, and in particular the potential goals, progress, timing, and results of preclinical studies and clinical trials, including as they are impacted by COVID-19 related disruption, are based on current information.  The potential impact on operations from the COVID-19 pandemic is inherently unknown and cannot be predicted with confidence and may cause actual results and performance to differ materially from the statements in this release, including without limitation, because of  the impact on general political and economic conditions, including as a result of efforts by governmental authorities to mitigate COVID-19, such as travel bans, shelter in place orders and third-party business closures and resource allocations, manufacturing and supply chain disruptions and limitations on patient access to commercial or clinical product. In addition to the impact of the COVID-19 pandemic, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in our business, including, without limitation: the potential that results of clinical or preclinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities, including the FDA, EMA, and PMDA, may not grant or may delay approval for our product candidates; the potential that we may not be successful in commercializing Galafold in Europe, Japan, the US and other geographies or our other product candidates if and when approved; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we may not be able to manufacture or supply sufficient clinical or commercial products; and the potential that we will need additional funding to complete all of our studies and manufacturing. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. Statements regarding corporate financial guidance and financial goals and the attainment of such goals. With respect to statements regarding projections of the Company's revenue and cash position, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2019, the Quarterly Report filed on Form 10-Q for the quarter ended March 31, 2020, and the Quarterly Report filed on Form 10-Q to be filed today. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and we undertake no obligation to revise or update this news release to reflect events or circumstances after the date hereof.CONTACTS:Investors: Amicus Therapeutics Andrew Faughnan Director, Investor Relations afaughnan@amicusrx.com (609) 662-3809Media: Amicus Therapeutics Diana Moore Head of Global Corporate Communications dmoore@amicusrx.com (609) 662-5079FOLD–GTABLE 1Amicus Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30,  2020 2019 2020 2019 Net product sales$62,353    $44,130    $122,878    $78,176    Cost of goods sold6,676    5,367    13,228    9,422    Gross profit55,677    38,763    109,650    68,754    Operating expenses:        Research and development69,611    70,981    158,731    135,574    Selling, general, and administrative34,657    42,578    74,872    86,881    Changes in fair value of contingent consideration payable715    480    1,646    1,863    Depreciation and amortization2,039    1,154    3,803    2,145    Total operating expenses107,022    115,193    239,052    226,463    Loss from operations(51,345)  (76,430)  (129,402)  (157,709)  Other income (expense):        Interest income865    2,599    2,380    5,238    Interest expense(3,635)  (4,625)  (7,364)  (11,079)  Loss on exchange of convertible notes—    (4,501)  —    (40,624)  Other income (expense)5,326    (877)  (2,990)  209    Loss before income tax(48,789)  (83,834)  (137,376)  (203,965)  Income tax expense(3,703)  (717)  (4,064)  (885)  Net loss attributable to common stockholders$(52,492)  $(84,551)  $(141,440)  $(204,850)  Net loss attributable to common stockholders per common share — basic and diluted$(0.20)  $(0.36)  $(0.55)  $(0.91)  Weighted-average common shares outstanding — basic and diluted 257,973,329    238,089,824    257,548,623    225,848,013   TABLE 2 Amicus Therapeutics, Inc. Consolidated Balance Sheets (Unaudited) (in thousands, except share and per share amounts) June 30, 2020 December 31, 2019 Assets    Current assets:    Cash and cash equivalents$164,573    $142,837    Investments in marketable securities145,017    309,903    Accounts receivable43,040    33,284    Inventories12,979    14,041    Prepaid expenses and other current assets18,275    20,008    Total current assets383,884    520,073    Operating lease right-of-use assets, less accumulated amortization of $6,219 and $5,342 at June 30, 2020 and December 31, 2019, respectively23,949    33,315    Property and equipment, less accumulated depreciation of $21,194 and $17,604 at June 30, 2020 and December 31, 2019, respectively46,945    47,705    In-process research & development23,000    23,000    Goodwill197,797    197,797    Other non-current assets25,876    28,317    Total Assets$701,451    $850,207    Liabilities and Stockholders’ Equity    Current liabilities:    Accounts payable$14,306    $21,722    Accrued expenses and other current liabilities85,478    99,901    Operating lease liabilities8,516    7,189    Total current liabilities108,300    128,812    Deferred reimbursements8,906    8,906    Convertible notes2,203    2,131    Senior secured term loan147,834    147,374    Contingent consideration payable20,027    22,681    Deferred income taxes5,051    5,051    Operating lease liabilities43,666    53,531    Other non-current liabilities4,511    5,296    Total liabilities340,498    373,782    Commitments and contingencies    Stockholders’ equity:    Common stock, $0.01 par value, 500,000,000 shares authorized, 258,223,842 and 255,417,869 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively2,614    2,598    Additional paid-in capital2,250,849    2,227,225    Accumulated other comprehensive loss:    Foreign currency translation adjustment4,865    2,785    Unrealized gain on available-for-sale securities288    40    Warrants12,387    12,387    Accumulated deficit(1,910,050)  (1,768,610)  Total stockholders’ equity360,953    476,425    Total Liabilities and Stockholders’ Equity$701,451    $850,207    TABLE 3Amicus Therapeutics, Inc. Reconciliation of Non-GAAP Financial Measures (in thousands)  Three Months Ended June 30,  Six Months Ended June 30,    2020  2019   2020  2019  Total operating expenses - as reported GAAP $  107,022  $    115,193   $   239,052  $    226,463   Research and development:           Share-based compensation    3,362    3,952     8,615  8,984  Selling, general and administrative:           Share-based compensation    5,046  5,983     12,389    13,695  Changes in fair value of contingent consideration payable     715    480     1,646  1,863  Depreciation and amortization    2,039    1,154     3,803    2,145  Total operating expense adjustments to reported GAAP    11,162    11,569     26,453    26,687  Total operating expenses - as adjusted $  95,860 $  103,624  $ 212,599 $  199,776