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FOLD Amicus Therapeutics

Amicus Therapeutics 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.

Company profile

Ticker
FOLD
Exchange
CEO
John Crowley
Employees
Incorporated
Location
Fiscal year end
Former names
AMICUS THERAPEUTICS INC
SEC CIK
Subsidiaries
1.Callidus Biopharma, Inc. • 2.Celenex, Inc. • 3.Scioderm, Inc. • 4.Scioderm Limited • 5.MiaMed, Inc. • 6.Amicus Therapeutics International Holding Limited • 7.Amicus Therapeutics UK Limited • 8.Amicus Therapeutics UK Operations Limited • 9.Amicus Therapeutics SAS • 10.Amicus Therapeutics B.V. ...
IRS number
200422823

FOLD stock data

(
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Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

5 Aug 21
18 Oct 21
31 Dec 21
Quarter (USD)
Jun 21 Mar 21 Dec 20 Sep 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 179.79M 179.79M 179.79M 179.79M 179.79M 179.79M
Cash burn (monthly) 2.75M (positive/no burn) 15.57M 20.64M 11.97M 16.68M
Cash used (since last report) 9.97M n/a 56.37M 74.73M 43.36M 60.38M
Cash remaining 169.82M n/a 123.42M 105.06M 136.43M 119.41M
Runway (months of cash) 61.7 n/a 7.9 5.1 11.4 7.2

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
9 Oct 21 David Michael Clark Common Stock Payment of exercise Dispose F No No 11.51 5,510 63.42K 168,879
1 Oct 21 Bradley L Campbell Common Stock Sell Dispose S No Yes 10 10,515 105.15K 457,268
1 Oct 21 Bradley L Campbell Common Stock Option exercise Acquire M No No 4.38 10,515 46.06K 467,783
1 Oct 21 Bradley L Campbell Stock Options Common Stock Option exercise Dispose M No No 4.38 10,515 46.06K 24,030
1 Oct 21 John F Crowley Common Stock Sell Dispose S No Yes 10 7,500 75K 832,345
1 Oct 21 Whitman Burke W Common Stock Buy Acquire P No Yes 9.564 1,500 14.35K 63,582
15 Sep 21 John F Crowley Common Stock Sell Dispose S No Yes 11.0831 22,000 243.83K 839,845
15 Sep 21 John F Crowley Common Stock Option exercise Acquire M No No 4.38 22,000 96.36K 861,845
15 Sep 21 John F Crowley Stock Options Common Stock Option exercise Dispose M No No 4.38 22,000 96.36K 46,935

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

13F holders
Current Prev Q Change
Total holders 233 253 -7.9%
Opened positions 32 50 -36.0%
Closed positions 52 69 -24.6%
Increased positions 82 95 -13.7%
Reduced positions 72 76 -5.3%
13F shares
Current Prev Q Change
Total value 2.87B 10.41B -72.5%
Total shares 272.87M 273.95M -0.4%
Total puts 545K 1.68M -67.5%
Total calls 1.45M 2.68M -45.7%
Total put/call ratio 0.4 0.6 -40.2%
Largest owners
Shares Value Change
Vanguard 24.73M $238.39M +1.4%
Perceptive Advisors 23.12M $222.89M +1.1%
Redmile 20.8M $200.51M -1.5%
BLK Blackrock 20.3M $195.71M -5.7%
Wellington Management 15.67M $151.07M +11.1%
JPM JPMorgan Chase & Co. 13.29M $128.08M +11.8%
Avoro Capital Advisors 12.45M $120.02M +1.6%
MS Morgan Stanley 11.66M $112.4M +17.0%
Palo Alto Investors 10M $96.42M +2.5%
STT State Street 9.44M $90.97M -1.1%
Largest transactions
Shares Bought/sold Change
JHG Janus Henderson 4.99M -4M -44.5%
Point72 Asset Management 3.87M +3.69M +2081.0%
Clearbridge Advisors 0 -2.89M EXIT
Gilder Gagnon Howe & Co 0 -2.31M EXIT
Two Sigma Investments 629.58K -1.72M -73.3%
MS Morgan Stanley 11.66M +1.69M +17.0%
Healthcare Of Ontario Pension Plan Trust Fund 228.3K -1.63M -87.7%
Eagle Asset Management 0 -1.62M EXIT
Great Point Partners 1.6M +1.6M NEW
Wellington Management 15.67M +1.56M +11.1%

Financial report summary

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Risks
  • If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals, we will not be able to commercialize our product or product candidates, and our ability to generate revenue will be materially impaired.
  • If the market opportunities for our product or product candidates are smaller than we believe they are, then our revenues may be adversely affected, and our business may suffer.
  • We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
  • A variety of risks associated with international operations could materially adversely affect our business.
  • Following the receipt of marketing approval of our product or any product candidates, the products may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices or healthcare reform initiatives, which would harm our business.
  • The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If we are found to have promoted off-label uses, we may become subject to significant liability.
  • Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
  • If the FDA or other applicable regulatory authorities approve generic or biosimilar products with claims that compete with our product or any of our product candidates, it could reduce our sales of our product or those product candidates.
  • We may expend our limited resources to pursue a particular product, product candidate or indication and fail to capitalize on a product, product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
  • Our product or product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization.
  • Any product or product candidate for which we obtain marketing approval could be subject to restrictions or withdrawal from the market and we may be subject to penalties or other enforcement actions if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product or our product candidates, when and if any of them are approved.
  • Our relationships with customers, healthcare providers, patients, patient organizations, charitable foundations and third-party payors will be subject to applicable anti-kickback, fraud and abuse, anti-bribery and corruption and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
  • If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of the FDA, EMA, PMDA or other foreign regulatory authorities, or do not otherwise produce favorable results, we may experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.
  • If we experience any of a number of possible unforeseen events in connection with our clinical trials, potential regulatory approval or commercialization of our product candidates could be delayed or prevented.
  • If we experience delays or difficulties in the enrollment of patients in our clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.
  • Initial results from a clinical trial do not ensure that the trial will be successful and success in preclinical or early stage clinical trials does not ensure success in later-stage clinical trials.
  • We may not be able to obtain or maintain orphan drug exclusivity for our product or product candidates. If our competitors are able to obtain orphan drug exclusivity for their products, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time.
  • Failure to obtain or maintain regulatory approval in foreign jurisdictions would prevent us from marketing our products abroad.
  • Our business activities involve the use of hazardous materials, which require compliance with environmental and occupational safety laws regulating the use of such materials. If we violate these laws, we could be subject to significant fines, liabilities or other adverse consequences.
  • If we are unable to obtain marketing approval for AT-GAA, or if it is approved and the label does not support reimbursement and we are unable to successfully commercialize AT-GAA, our business could be materially harmed.
  • Our gene therapy product candidates are based on novel technologies, which makes it difficult to predict the time and cost of product candidate development and subsequently obtaining regulatory approval.
  • We may encounter difficulties manufacturing our gene therapy which could impact timing and availability of clinical and commercial supply.
  • Use of third parties to manufacture our product or product candidates may increase the risk that we will not have sufficient quantities of our product or product candidates or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
  • We may be unable to enter into agreements for commercial supply with third-party manufacturers or may be unable to do so on acceptable terms. Even if we enter into these agreements, the manufacturers of each product candidate will be single source suppliers to us for a significant period of time.
  • We rely on third parties to conduct certain preclinical development activities and our clinical trials, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.
  • We may not be successful in maintaining or establishing collaborations, which could adversely affect our ability to develop and, particularly in international markets, commercialize products.
  • Materials necessary to manufacture our product or product candidates may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our product or product candidates.
  • Manufacturing issues may arise that could increase product and regulatory approval costs or delay commercialization.
  • We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future.
  • We may never become profitable even though we currently generate revenue from the sale of products.
  • If we require substantial additional capital to fund our operations and we fail to obtain necessary financing, we may be unable to complete the development and commercialization of our product and development and commercialization of our product candidates.
  • Servicing our debt requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial debt.
  • Foreign currency exchange rate fluctuations could harm our financial results.
  • Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.
  • Our executive officers, directors and principal stockholders maintain the ability to exert significant influence and control over matters submitted to our stockholders for approval.
  • Because we do not anticipate paying any cash dividends on our capital in the foreseeable future, capital appreciation, if any, will be our stockholders sole source of gain.
  • Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
  • If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection is not sufficiently broad, our competitors could develop and commercialize technology and products similar or identical to ours, and our ability to successfully commercialize our technology and products may be adversely affected.
  • We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time consuming and unsuccessful.
  • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
  • We may be subject to claims by third parties asserting that we or our employees have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.
  • If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business.
  • We have not yet registered our trademarks in all of our potential markets, and failure to secure those registrations could adversely affect our business.
  • Our rights to develop and commercialize our gene therapy product candidates are subject, in part, to the terms and conditions of licenses granted to us by others.
  • The novel coronavirus ("COVID-19") pandemic and efforts to reduce its spread may negatively impact our business and operations.
  • Our future success depends on our ability to retain our Chief Executive Officer and other key executives and to attract, retain and motivate qualified personnel.
  • We expect to expand our development, regulatory and sales and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
  • Our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.
  • If our enterprise risk program, global risk committee and other compliance methods are not effective, our business, financial condition and operating results may be adversely affected
  • Our business and operations would suffer in the event of computer system failures or security breaches.
  • We may acquire other assets or businesses, or form collaborations or make investments in other companies or technologies that could harm our operating results, dilute our stockholders' ownership, increase our debt, or cause us to incur significant expense.
  • Provisions in our corporate charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • The price of our common stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our common stock.
  • A significant portion of our total outstanding shares may be sold into the market. This could cause the market price of our common stock to drop significantly, even if our business is doing well.
  • We may fail to qualify for continued listing on The NASDAQ Global Market which could make it more difficult for investors to sell their shares.
  • If securities or industry analysts do not publish research or reports or publish unfavorable research about our business, the price of our common stock and trading volume could decline.
  • We have broad discretion in the use of our cash and cash equivalents and may not use them effectively.
  • If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
  • Litigation may adversely affect our business, financial condition, results of operations or liquidity.
  • We may be exposed to employment-related claims and losses which could have an adverse effect on our business.
Management Discussion
  •  Net Product Sales. Net product sales increased $15.1 million during the three months ended June 30, 2021 compared to the same period in the prior year. The increase was primarily due to continued growth in the U.S., Europe and Japan markets.
  • The $6.6 million decrease in research and development costs was primarily due to the timing of clinical research and manufacturing costs associated with the advancement of clinical studies in the Pompe program and a decrease in personnel costs primarily due to realignment with strategic priorities.
  • Selling, General, and Administrative Expense. Selling, general, and administrative expense increased $7.6 million, primarily driven by increased personnel costs.
Content analysis
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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. freshman Avg
New words: alleging, behalf, brought, Calculation, Certification, complaint, Court, Crowley, Daphne, District, document, duly, Eastern, embedded, Equivalent, Exhibit, Inline, instance, Interactive, John, lawsuit, Linkbase, LOPD, LTFU, merit, MHRA, monetary, NDA, opened, Page, promulgated, Quimi, registrant, relief, Restoring, Schema, Scheme, Section, site, Taxonomy, Teva, thereunto, titled, undersigned, vigorously, withholding, XBRL
Removed: March, molecule, small, vested

Patents

APP
Utility
Methods of Treating Fabry Disease in Patients Having a Mutation in the GLA Gene
14 Oct 21
Provided are methods of treating a patient diagnosed with Fabry disease and methods of enhancing α-galactosidase A in a patient diagnosed with or suspected of having Fabry disease.
APP
Utility
TATk-CDKL5 Fusion Proteins, Compositions, Formulations, and Use Thereof
2 Sep 21
Disclosed herein are compositions and formulations containing a TATκ-CDKL5 fusion protein.
APP
Utility
Augmented Acid Alpha-glucosidase for the Treatment of Pompe Disease
2 Sep 21
A method for treating Pompe disease including administration of recombinant human acid α-glucosidase having optimal glycosylation with mannose-6-phosphate residues in combination with an amount of miglustat effective to maximize tissue uptake of recombinant human acid α-glucosidase while minimizing inhibition of the enzymatic activity of the recombinant human acid α-glucosidase is provided.
APP
Utility
Highly Potent Acid Alpha-glucosidase with Enhanced Carbohydrates
26 Aug 21
Recombinant human alpha glucosidase (rhGAA) composition derived from CHO cells that contains a more optimized glycan composition consisting of a higher amount of rhGAA containing N-glycans carrying mannose-6-phosphate (M6P) or bis-M6P than conventional rhGAAs, along with low amount of non-phosphorylated high mannose glycans, and low amount of terminal galactose on complex oligosaccharides.
GRANT
Utility
Disulfide bond stabilized polypeptide compositions and methods of use
24 Aug 21
Provided herein are polypeptides comprising one or more non-native cysteine residues that form a disulfide bridge between non-native cysteines within the protein or between non-native cysteines of two monomers of the protein.