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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Amicus Therapeutics Inc | NASDAQ:FOLD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.16 | 1.54% | 10.58 | 10.58 | 10.59 | 10.79 | 10.58 | 10.74 | 140,726 | 15:20:20 |
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
2020 Key Strategic Priorities
Second Quarter 2020 Financial Results
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
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 Program
Galafold (migalastat) Oral Precision Medicine for Fabry Disease
AT-GAA for Pompe Disease
Gene Therapy Portfolio
Conference Call and WebcastAmicus 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 INFORMATION
ADVERSE 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 InformationTreatment 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.
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 StatementsThis 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 TherapeuticsAndrew FaughnanDirector, Investor Relationsafaughnan@amicusrx.com (609) 662-3809
Media:Amicus TherapeuticsDiana MooreHead of Global Corporate Communicationsdmoore@amicusrx.com(609) 662-5079
FOLD–G
TABLE 1
Amicus 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 sold | 6,676 | 5,367 | 13,228 | 9,422 | |||||||||||||||
Gross profit | 55,677 | 38,763 | 109,650 | 68,754 | |||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development | 69,611 | 70,981 | 158,731 | 135,574 | |||||||||||||||
Selling, general, and administrative | 34,657 | 42,578 | 74,872 | 86,881 | |||||||||||||||
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 expenses | 107,022 | 115,193 | 239,052 | 226,463 | |||||||||||||||
Loss from operations | (51,345 | ) | (76,430 | ) | (129,402 | ) | (157,709 | ) | |||||||||||
Other income (expense): | |||||||||||||||||||
Interest income | 865 | 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 securities | 145,017 | 309,903 | |||||||
Accounts receivable | 43,040 | 33,284 | |||||||
Inventories | 12,979 | 14,041 | |||||||
Prepaid expenses and other current assets | 18,275 | 20,008 | |||||||
Total current assets | 383,884 | 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, respectively | 23,949 | 33,315 | |||||||
Property and equipment, less accumulated depreciation of $21,194 and $17,604 at June 30, 2020 and December 31, 2019, respectively | 46,945 | 47,705 | |||||||
In-process research & development | 23,000 | 23,000 | |||||||
Goodwill | 197,797 | 197,797 | |||||||
Other non-current assets | 25,876 | 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 liabilities | 85,478 | 99,901 | |||||||
Operating lease liabilities | 8,516 | 7,189 | |||||||
Total current liabilities | 108,300 | 128,812 | |||||||
Deferred reimbursements | 8,906 | 8,906 | |||||||
Convertible notes | 2,203 | 2,131 | |||||||
Senior secured term loan | 147,834 | 147,374 | |||||||
Contingent consideration payable | 20,027 | 22,681 | |||||||
Deferred income taxes | 5,051 | 5,051 | |||||||
Operating lease liabilities | 43,666 | 53,531 | |||||||
Other non-current liabilities | 4,511 | 5,296 | |||||||
Total liabilities | 340,498 | 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, respectively | 2,614 | 2,598 | |||||||
Additional paid-in capital | 2,250,849 | 2,227,225 | |||||||
Accumulated other comprehensive loss: | |||||||||
Foreign currency translation adjustment | 4,865 | 2,785 | |||||||
Unrealized gain on available-for-sale securities | 288 | 40 | |||||||
Warrants | 12,387 | 12,387 | |||||||
Accumulated deficit | (1,910,050 | ) | (1,768,610 | ) | |||||
Total stockholders’ equity | 360,953 | 476,425 | |||||||
Total Liabilities and Stockholders’ Equity | $ | 701,451 | $ | 850,207 |
TABLE 3
Amicus 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 |
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