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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT PURSUANT TO
SECTION
13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of
earliest event reported): February 19, 2025
AMICUS THERAPEUTICS, INC.
(Exact
Name of Registrant as Specified in Its Charter)
| Delaware |
|
001-33497 |
|
71-0869350 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
47 Hulfish Street,
Princeton, NJ 08542
(Address of Principal
Executive Offices, and Zip Code)
609-662-2000
Registrant’s
Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since
Last Report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant
to Section 12(b) of the Act:
| Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock Par Value $0.01 |
|
FOLD |
|
Nasdaq |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934
(17 CFR §240.12b-2). Emerging growth company ¨
If an emerging growth company, indicate
by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 – Results of Operations
and Financial Condition
On February 19, 2025, Amicus Therapeutics, Inc.
(the “Company”) issued a press release announcing its financial results for the fiscal year ended December 31, 2024. A copy
of this press release is attached hereto as Exhibit 99.1. The Company will host a conference call and webcast on February 19, 2025 to
discuss its full year results of operations. A copy of the conference call presentation materials is attached hereto as Exhibit 99.2.
Both exhibits are incorporated herein by reference.
In accordance with General Instruction B.2. of
Form 8-K, the information in this Current Report on Form 8-K and the Exhibits shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability
of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits:
Signature Page
Pursuant to the requirements of the
Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly
authorized.
| |
AMICUS THERAPEUTICS, INC. |
| Date: February 19, 2025 |
By: |
/s/ Ellen S. Rosenberg |
| |
Name: |
Ellen S. Rosenberg |
| |
Title: |
Chief Legal Officer and Corporate Secretary |
Exhibit
99.1
Amicus
Therapeutics Announces Full-Year 2024
Financial Results and Corporate Updates
2024
Total Revenue of $528.3M, a 33% Increase Year-over-Year
Projecting
2025 Total Revenue Growth of 17-24% at CER
Anticipate
Achieving Positive GAAP Net Income During H2 2025
Conference
Call and Webcast Today at 8:30 a.m. ET
PRINCETON,
NJ, Feb. 19, 2025 – 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 full-year ended December 31,
2024.
“We
closed 2024 beating expectations with exceptional revenue growth of 33 percent. With our portfolio and global rare disease capabilities,
we have a clear path to deliver continued revenue growth and accelerating profitability in 2025 and the years ahead. We have firmly established
Amicus as a unique biotechnology company: two growing medicines with long runways, a leverageable infrastructure with patients at the
center, and the financial strength to continue to build the business and our leadership in rare diseases,” said Bradley Campbell,
President and Chief Executive Officer of Amicus Therapeutics, Inc.
Corporate
Highlights:
| · | Total
revenues for the full-year 2024 were $528.3 million, reflecting operational growth measured
at constant exchange rates (CER)1 of 33% and a small currency impact of $1.1 million
or 1%. Fourth quarter total revenues were $149.7 million, up 30% as reported and at CER.
For the full year 2025, the Company provides total revenue growth guidance of +17% to +24%
on a constant currency basis (CER)1. |
| (in thousands) | |
Three Months Ended
December 31, | |
Year over Year % Growth | |
Twelve Months Ended December 31, | |
Year over Year % Growth | |
| |
2024 | |
2023 | |
Reported | |
at CER1 | |
2024 | |
2023 | |
Reported | |
at CER1 | |
| Galafold® | |
| 127,497 | |
| 106,601 | |
| 20 | % |
| 20 | % |
| 458,054 | |
| 387,777 | |
| 18 | % |
| 19 | % |
| Pombiliti® + Opfolda® | |
| 22,209 | |
| 8,481 | |
| 162 | % |
| 161 | % |
| 70,241 | |
| 11,579 | |
| 507 | % |
| 504 | % |
| Net Product Revenues | |
| 149,706 | |
| 115,082 | |
| 30 | % |
| 30 | % |
$ | 528,295 | |
$ | 399,356 | |
| 32 | % |
| 33 | % |
| · | Galafold
(migalastat) net product sales for the full-year 2024 were $458.1 million, representing
a year-over-year increase of 18%, or 19% at CER. Fourth quarter net product sales were $127.5
million. At the end of 2024, there were ~2,730 people living with Fabry disease on Galafold
following a year of increased demand. For the full year 2025, the Company provides revenue
growth guidance for Galafold of +10% to +15% on a constant currency basis (CER)1. |
| · | Pombiliti
(cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales for the full-year 2024
were $70.2 million. Fourth quarter net product sales were $22.2 million. Following a
successful commercial launch in the U.S., Germany, Austria, Spain and the U.K., there were
~220 patients treated or scheduled with commercial product as of the end of 2024. For the
full year 2025, the Company provides revenue growth guidance for Pombiliti + Opfolda of +65%
to +85% on a constant currency basis (CER)1. |
| · | Multiple
Pombiliti + Opfolda pricing and reimbursement agreements recently achieved. Agreements
completed in late 2024 and early 2025 include Italy, Sweden, Switzerland, Czech Republic
and most recently the Netherlands. First commercial patients from these countries are anticipated
to begin treatment over the first half of 2025. Additionally, Pombiliti + Opfolda received
regulatory approval in Australia and the Company anticipates new regulatory decisions in
Canada and Japan in 2025 as well as additional reimbursement agreements throughout the year. |
| · | Amicus
is focused on delivering significant long-term revenue growth and anticipates surpassing
$1 billion in total sales in 2028. The Company anticipates continuing to grow its current
commercial business with Galafold and Pombiliti + Opfolda resulting in strong total revenue
growth. |
| · | Total
GAAP operating expenses of $450.5 million for the full year 2024 increased by 2.6% as
compared to $439.2 million for the full year 2023. Total non-GAAP operating expenses2
were up 1.8% to $347.8 million for the full year 2024 as compared to $341.6 million
for the full year 2023. For the full year 2025, the Company provides non-GAAP operating expense4
guidance range of $350 million to $370 million. |
| · | GAAP
net loss was $56.1 million, or $0.18 per share basic and diluted, for the full year 2024,
and was reduced compared to a net loss of $151.6 million, or $0.51 per share basic and diluted,
for the full year 2023. GAAP net income was $14.7 million, or $0.05 per share basic
and diluted, for the fourth quarter 2024, compared to a net loss of $33.8 million, or $0.11
per share basic and diluted, for the fourth quarter 2023. The company anticipates achieving
positive GAAP net income during H2 2025. |
| · | Non-GAAP
net income2,3 was $73.9 million, or $0.24 per share, for the full year 2024,
compared to a non-GAAP net loss of $38.5 million, or $0.13 per share basic and diluted, for
the full year 2023. Non-GAAP net income was $29.2 million, or $0.10 per share basic and $0.09
per share diluted, for the fourth quarter 2024, compared to a net income of $2.6 million,
or $0.01 per share basic and diluted, for the fourth quarter 2023. |
| · | Cash,
cash equivalents, and marketable securities totaled $249.9 million at December 31,
2024, compared to $249.8 million at September 30, 2024 and $286.2 million at December 31,
2023. |
2025
Financial Guidance
To
advance our strategy and expand our leadership in Fabry and Pompe disease, our financial guidance for 2025 is as follows:
| | Total Revenue Growth1 | | |
17% to 24% | |
| | Galafold Revenue Growth1 | | |
10% to 15% | |
| | Pombiliti + Opfolda Growth1 | | |
65% to 85% | |
| | Gross Margin | | |
Mid 80% | |
| | Non-GAAP Operating Expenses4 | | |
$350M to $370M | |
| | GAAP Net Income | | |
Positive during H2 2025 | |
1
In order to illustrate underlying performance, Amicus discusses its results in terms of constant exchange rate (CER) growth. This
represents growth calculated as if the exchange rates had remained unchanged from those used in the comparative period.
2
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.
3
Amicus defines non-GAAP Net (Loss) Income as GAAP Net (Loss) Income excluding the impact of share-based compensation expense, changes
in fair value of contingent consideration, loss on impairment of assets, depreciation and amortization, acquisition related income (expense),
loss on extinguishment of debt, restructuring charges and income taxes.
4
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.
Conference
Call and Webcast
Amicus
Therapeutics will host a conference call and audio webcast today, February 19, 2025, at 8:30 a.m. ET to discuss the full-year
2024 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register
using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal
PIN number to access the event.
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.
An archived webcast and accompanying slides will be available on the Company's website shortly after the conclusion of the live event.
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 galactosidase alpha gene (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 people living with Fabry disease may have amenable GLA variants, though amenability
rates within this range vary by geography. Galafold is approved in more than 40 countries around the world, including the U.S., EU, U.K.,
and Japan.
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.
About
Pombiliti + Opfolda
Pombiliti
+ Opfolda, is a two-component therapy that consists of cipaglucosidase alfa-atga, a bis-M6P-enriched rhGAA that facilitates high-affinity
uptake through the M6P receptor while retaining its capacity for processing into the most active form of the enzyme, and the oral enzyme
stabilizer, miglustat, that’s designed to reduce loss of enzyme activity in the blood.
U.S.
INDICATIONS AND USAGE
POMBILITI
in combination with OPFOLDA is indicated for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase
[GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT).
SAFETY
INFORMATION
HYPERSENSITIVITY
REACTIONS INCLUDING ANAPHYLAXIS: Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily
available. If a severe hypersensitivity reaction occurs, POMBILITI should be discontinued immediately and appropriate medical treatment
should be initiated. INFUSION-ASSOCIATED REACTIONS (IARs): If severe IARs occur, immediately discontinue POMBILITI and initiate appropriate
medical treatment. RISK OF ACUTE CARDIORESPIRATORY FAILURE IN SUSCEPTIBLE PATIENTS: Patients susceptible to fluid volume overload, or
those with acute underlying respiratory illness or compromised cardiac or respiratory function, may be at risk of serious exacerbation
of their cardiac or respiratory status during POMBILITI infusion. See PI for complete Boxed Warning. CONTRAINDICATION: POMBILITI
in combination with Opfolda is contraindicated in pregnancy. EMBRYO-FETAL TOXICITY: May cause embryo-fetal harm.
Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for
at least 60 days after the last dose. Adverse Reactions: Most common adverse reactions ≥ 5% are headache, diarrhea,
fatigue, nausea, abdominal pain, and pyrexia. Please see full PRESCRIBING INFORMATION, including BOXED WARNING, for POMBILITI
(cipaglucosidase alfa-atga) LINK and full PRESCRIBING INFORMATION for OPFOLDA (miglustat) LINK.
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 diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing
and expanding a pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. For more information please visit the
company’s website at www.amicusrx.com, and follow on X 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 use these non-GAAP
measures as key performance measures for the purpose of evaluating operational performance and cash requirements internally. 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. When we provide our expectation for non-GAAP operating
expenses and profitability 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 Statement
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 pricing and reimbursement authorities, are based on current information. 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 may not grant or may delay
approval for our product candidates; the potential that required regulatory inspections may be delayed or not be successful and delay
or prevent product approval; the potential that we may not be successful in negotiations with pricing and reimbursement authorities;
the potential that we may not be successful in commercializing Galafold and/or Pombiliti and Opfolda in Europe, the UK, the US and other
geographies; 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, the manufacturing, and commercialization of our products. With respect
to statements regarding corporate financial guidance and financial goals and the expected attainment of such goals and projections of
the Company's revenue, non-GAAP profitability 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, 2024 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.
CONTACT:
Investors:
Amicus
Therapeutics
Andrew
Faughnan
Vice
President, Investor Relations
afaughnan@amicusrx.com
(609)
662-3809
Media:
Amicus
Therapeutics
Diana
Moore
Head
of Global Corporate Affairs and Communications
dmoore@amicusrx.com
(609)
662-5079
FOLD-G
TABLE
1
Amicus
Therapeutics, Inc.
Consolidated
Statements of Operations
(in
thousands, except share and per share amounts)
| | |
Years
ended December 31, | |
| | |
2024 | | |
2023 | | |
2022 | |
| Net product sales | |
$ | 528,295 | | |
$ | 399,356 | | |
$ | 329,233 | |
| Cost of goods sold | |
| 52,943 | | |
| 37,326 | | |
| 38,599 | |
| Gross profit | |
| 475,352 | | |
| 362,030 | | |
| 290,634 | |
| Operating expenses: | |
| | | |
| | | |
| | |
| Research and development | |
| 109,362 | | |
| 152,381 | | |
| 276,677 | |
| Selling, general, and administrative | |
| 323,379 | | |
| 275,270 | | |
| 213,041 | |
| Changes in fair value of contingent
consideration payable | |
| — | | |
| 2,583 | | |
| 1,078 | |
| Loss on impairment of assets | |
| — | | |
| 1,134 | | |
| 6,616 | |
| Restructuring charges | |
| 9,188 | | |
| — | | |
| — | |
| Depreciation and
amortization | |
| 8,547 | | |
| 7,873 | | |
| 5,342 | |
| Total operating expenses | |
| 450,476 | | |
| 439,241 | | |
| 502,754 | |
| Income (loss) from operations | |
| 24,876 | | |
| (77,211 | ) | |
| (212,120 | ) |
| Other (expense) income: | |
| | | |
| | | |
| | |
| Interest income | |
| 5,407 | | |
| 7,078 | | |
| 3,024 | |
| Interest expense | |
| (49,598 | ) | |
| (50,149 | ) | |
| (37,119 | ) |
| Loss on extinguishment of debt | |
| — | | |
| (13,933 | ) | |
| — | |
| Other (expense)
income | |
| (9,441 | ) | |
| (15,886 | ) | |
| 4,176 | |
| Loss before income tax | |
| (28,756 | ) | |
| (150,101 | ) | |
| (242,039 | ) |
| Income tax (expense)
benefit | |
| (27,350 | ) | |
| (1,483 | ) | |
| 5,471 | |
| Net loss attributable
to common stockholders | |
$ | (56,106 | ) | |
$ | (151,584 | ) | |
$ | (236,568 | ) |
| Net loss attributable to common stockholders
per common share — basic and diluted | |
$ | (0.18 | ) | |
$ | (0.51 | ) | |
$ | (0.82 | ) |
| Weighted-average common shares outstanding —
basic and diluted | |
| 304,380,502 | | |
| 295,164,515 | | |
| 289,057,198 | |
TABLE
2
Amicus
Therapeutics, Inc.
Consolidated
Balance Sheets
(in
thousands, except share and per share amounts)
| | |
December 31, | |
| | |
2024 | | |
2023 | |
| Assets | |
| | | |
| | |
| Current assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 213,752 | | |
$ | 246,994 | |
| Investments in marketable securities | |
| 36,194 | | |
| 39,206 | |
| Accounts receivable | |
| 101,099 | | |
| 87,632 | |
| Inventories | |
| 118,782 | | |
| 59,696 | |
| Prepaid expenses
and other current assets | |
| 34,909 | | |
| 49,533 | |
| Total current assets | |
| 504,736 | | |
| 483,061 | |
| Operating lease right-of-use assets,
net | |
| 22,278 | | |
| 26,312 | |
| Property and equipment, less accumulated
depreciation of $28,775 and $25,429 at December 31, 2024 and 2023, respectively | |
| 29,383 | | |
| 31,667 | |
| Intangible assets, less accumulated
amortization of $5,802 and $2,510 at December 31, 2024 and December 31, 2023, respectively | |
| 17,198 | | |
| 20,490 | |
| Goodwill | |
| 197,797 | | |
| 197,797 | |
| Other non-current
assets | |
| 13,641 | | |
| 18,553 | |
| Total Assets | |
$ | 785,033 | | |
$ | 777,880 | |
| Liabilities and Stockholders' Equity | |
| | | |
| | |
| Current liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 12,947 | | |
$ | 15,120 | |
| Accrued expenses and other current
liabilities | |
| 127,300 | | |
| 144,245 | |
| Operating lease
liabilities | |
| 8,455 | | |
| 8,324 | |
| Total current liabilities | |
| 148,702 | | |
| 167,689 | |
| Long-term debt | |
| 390,111 | | |
| 387,858 | |
| Operating lease liabilities | |
| 45,078 | | |
| 48,877 | |
| Other non-current
liabilities | |
| 7,097 | | |
| 13,282 | |
| Total liabilities | |
| 590,988 | | |
| 617,706 | |
| Commitments and contingencies | |
| | | |
| | |
| Stockholders' equity: | |
| | | |
| | |
| Common stock, $0.01 par value, 500,000,000
shares authorized, 299,041,653 and 293,594,209 shares issued and outstanding at December 31, 2024 and 2023, respectively | |
| 2,944 | | |
| 2,918 | |
| Additional paid-in capital | |
| 2,926,115 | | |
| 2,836,018 | |
| Accumulated other comprehensive gain (loss): | |
| | | |
| | |
| Foreign currency translation adjustment | |
| 5,302 | | |
| 5,429 | |
| Unrealized loss on available-for-sale
securities | |
| (207 | ) | |
| (188 | ) |
| Warrants | |
| 71 | | |
| 71 | |
| Accumulated deficit | |
| (2,740,180 | ) | |
| (2,684,074 | ) |
| Total stockholders'
equity | |
| 194,045 | | |
| 160,174 | |
| Total Liabilities
and Stockholders' Equity | |
$ | 785,033 | | |
$ | 777,880 | |
TABLE
3
Amicus
Therapeutics, Inc.
Reconciliation
of Non-GAAP Financial Measures
(in
thousands)
(Unaudited)
| | |
Years Ended December 31, | |
| | |
2024 | | |
2023 | | |
2022 | |
| Total GAAP operating expenses | |
$ | 450,476 | | |
$ | 439,241 | | |
$ | 502,754 | |
| Research and development: | |
| | | |
| | | |
| | |
| Share-based compensation | |
| 15,969 | | |
| 21,469 | | |
| 25,089 | |
| Selling, general and administrative: | |
| | | |
| | | |
| | |
| Share-based compensation | |
| 68,936 | | |
| 64,608 | | |
| 51,423 | |
| Loss on impairment of assets | |
| — | | |
| 1,134 | | |
| 6,616 | |
| Restructuring charge | |
| 9,188 | | |
| — | | |
| — | |
| Changes in fair value of contingent consideration payable | |
| — | | |
| 2,583 | | |
| 1,078 | |
| Depreciation and amortization | |
| 8,547 | | |
| 7,873 | | |
| 5,342 | |
| Total Non-GAAP operating expense adjustments | |
| 102,640 | | |
| 97,667 | | |
| 89,548 | |
| Total Non-GAAP operating expenses | |
$ | 347,836 | | |
$ | 341,574 | | |
$ | 413,206 | |
TABLE
4
Amicus
Therapeutics, Inc.
Reconciliation
of Non-GAAP Financial Measures
(in
thousands, except share and per share amounts)
(Unaudited)
| | |
Three
Months Ended December 31, | | |
Years
Ended December 31, | |
| | |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| GAAP net income (loss) | |
$ | 14,739 | | |
$ | (33,843 | ) | |
$ | (56,106 | ) | |
$ | (151,584 | ) |
| Share-based compensation | |
| 19,217 | | |
| 18,095 | | |
| 84,905 | | |
| 86,077 | |
| Loss on impairment of assets | |
| — | | |
| — | | |
| — | | |
| 1,134 | |
| Changes in fair value of contingent consideration payable | |
| — | | |
| — | | |
| — | | |
| 2,583 | |
| Depreciation and amortization | |
| 2,041 | | |
| 2,182 | | |
| 8,547 | | |
| 7,873 | |
| Loss on extinguishment of debt | |
| — | | |
| 13,933 | | |
| — | | |
| 13,933 | |
| Restructuring charges | |
| — | | |
| — | | |
| 9,188 | | |
| — | |
| Income tax (benefit) expense | |
| (6,805 | ) | |
| 2,183 | | |
| 27,350 | | |
| 1,483 | |
| Non-GAAP net income (loss) | |
$ | 29,192 | | |
$ | 2,550 | | |
$ | 73,884 | | |
$ | (38,501 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Non-GAAP net
income (loss) attributable to common stockholders per common share — basic | |
$ | 0.10 | | |
$ | 0.01 | | |
$ | 0.24 | | |
$ | (0.13 | ) |
| Non-GAAP net
income (loss) attributable to common stockholders per common share — diluted | |
$ | 0.09 | | |
$ | 0.01 | | |
$ | 0.24 | | |
$ | (0.13 | ) |
| Weighted-average common shares outstanding — basic | |
| 306,136,125 | | |
| 300,648,503 | | |
| 304,380,502 | | |
| 295,164,515 | |
| Weighted-average common shares outstanding — diluted | |
| 310,146,355 | | |
| 306,787,370 | | |
| 308,463,764 | | |
| 295,164,515 | |
Exhibit 99.1
| AT THE FOREFRONT OF
THERAPIES FOR RARE DISEASES
FY24 Results
Conference Call
& Webcast
February 19, 2025 |
| 2
Forward-Looking Statements
This presentation 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 presentation 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 pricing and reimbursement authorities, are based on current information. 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 may not grant or
may delay approval for our product candidates; the potential that required regulatory inspections may be delayed or not be successful and delay or prevent product approval; the
potential that we may not be successful in negotiations with pricing and reimbursement authorities; the potential that we may not be successful in commercializing Galafold and/or
Pombiliti and Opfolda in Europe, the UK, the US and other geographies; 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, the manufacturing, and commercialization of our products. With respect to statements regarding corporate financial guidance and financial goals and the
expected attainment of such goals and projections of the Company's revenue, non-GAAP profitability 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, 2024 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.
Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this presentation 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. 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. |
| A Rare Company
A unique story in biotech with significant revenue growth and profitability
3 1 At CER: Constant Exchange Rates
$528M
2024 Total Revenue
(+33% Growth)1
$1B+
Total Revenues
Expected in 2028
65-85%
FY 2025
Pombiliti+Opfolda
Revenue Growth1
First Oral
Precision
Medicine for
Fabry Disease
First Two-Component Therapy 10-15% for Pompe Disease
FY 2025
Galafold Revenue
Growth1
FY 2024
Non-GAAP
Profitability
Achieved
Leverageable
Global
Commercial
Organization |
| 4
2024 Results
1 Full-Year 2024 guidance provided at CER (Constant Exchange Rates) using Full-Year 2023 Average Exchange Rates
We closed 2024 with exceptional growth of 33% and strong momentum heading into 2025
FY 2024 Guidance Results
Total Revenue Growth1 30% to 32% 33%
Galafold Revenue Growth1 16% to 18% 19%
Pombiliti + Opfolda Revenue1 $69M to $71M $70.2M
Non-GAAP Operating Expense $340M to $350M $347.8M
Non-GAAP Net Income Non-GAAP Profitable $73.9M |
| 5 1 CER: Constant Exchange Rates
2025 Strategic Priorities
Deliver total revenue growth of 17-24% at CER1
Double-digit Galafold® revenue growth of 10-15% at CER1
Pombiliti®+ Opfolda® revenue growth of 65-85% at CER1
Advance ongoing studies to broaden labels and strengthen
scientific leadership in Fabry and Pompe diseases
Deliver positive GAAP net income during H2 2025 |
| 6
Galafold® (migalastat)
Continued Growth
Building a leadership position
in the treatment of Fabry disease |
| 7
Only approved oral treatment in Fabry disease and standard of care for amenable patients
2024 Galafold Success (as of December 31, 2024)
Galafold is indicated for adults with a confirmed diagnosis of Fabry disease and an amenable variant. The most common adverse reactions reported with Galafold (≥10%)
were headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia. For additional information about Galafold, including the full U.S. Prescribing Information, please
visit https://amicusrx.com//pi/galafold.pdf. 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.
A unique mechanism of action for
Fabry patients with amenable variants
35-50%
Fabry Patients
Amenable to
Galafold 40+
Countries with
Regulatory
Approvals
~2,730
Individuals
Treated2
$458.1M
FY24 Galafold
Revenue
+19%
FY24 Galafold
Growth at CER1
65%
Share of Treated
Amenable Patients
1 CER: Constant Exchange Rates
2 As of YE 2024 |
| 8
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25
$5M
$37M
$91M
$182M
$261M
$306M
$329M
$388M
$458M
Global mix of naïve (~60%) and switch
(~40%) patients2
Expanding market through uptake in
naïve population as well as geographic
and label expansion
Maintaining >90% adherence and
compliance through HCP and patient
education and support
Expect non-linear quarterly growth
to continue due to uneven ordering
patterns and FX fluctuations
Galafold Performance
Strong FY 2025 Galafold growth guidance of 10-15% at CER1
Q1
$99M
Q2
$111M
Q3
$120M
Q4
$128M
+10-15%1
FY 2024 Galafold reported revenue of $458.1M (+19% growth at CER)
1 CER: Constant Exchange Rates
2 Data on file |
| 9
Multiple initiatives leveraging AI and family screening to improve diagnosis of Fabry disease
Improving Diagnosis of Fabry Disease
580K+ medical records screened
100 people with highest risk of Fabry identified
Outreach ongoing to offer genetic testing
Initial findings from Fabry pilot programs in U.K.
– Minority and low-income groups significantly under-represented
– >90% of diagnosed Fabry population white
– ~85% from the least deprived areas
Initiative already identified low-income families who otherwise
wouldn’t have been diagnosed
Collaboration using AI to diagnose Fabry Collaboration for change in health disparity
Additional initiatives in several countries ongoing leveraging AI and/or targeted screening |
| 10
Pombiliti® (cipaglucosidase alfa-atga)
Opfolda® (miglustat)
Potential to establish a new standard of care
for people living with late-onset Pompe disease
+ |
| 11
Pombiliti + Opfolda Performance
Successful first full year of launch in the U.S., Germany, Austria, Spain and the U.K.
FY23 FY24
U.S.
Ex-U.S. 43%
57%
Annual Revenue 2024 Geographic Mix
Q1
$11M
Q2
$16M
Q3
$21M
Q4
$22M
$70.2M
$11.6M
1 CER: Constant Exchange Rates |
| 12
~220 individuals treated or scheduled provides strong foundation for 2025
Pombiliti + Opfolda Global Launch Metrics
• ~220 patients have been treated or scheduled to
be treated with commercial product
– ~209 treated patients
– ~25 new prescriptions in Q4
• All eligible clinical trial patients from launched
markets on commercial therapy by end of 1H24
• New commercial patients time through U.S.
insurance process optimized to <30 days
• Patients starting Pombiliti + Opfolda at
proportional rate to the respective market share
120
220
4Q23 1Q24 2Q24 3Q24 4Q24
Global Launch: Individuals Treated or Scheduled
~ |
| 13
Pombiliti + Opfolda Growth Drivers
Amicus focused on key drivers of growth in 2025
Increasing number of net new patients
Increasing depth and breadth of prescribers
Expect to launch in up to 10 new countries
throughout 2025
Continuing to drive differentiation through
evidence generation and real-world evidence
Anticipate 90%+ compliance and adherence
1 At CER: Constant Exchange Rates
$12M
$70M
FY23 FY24 FY25
Pombiliti + Opfolda Revenue
+65-85%1 |
| 14
New reimbursement agreements completed in:
Regulatory approvals anticipated in 2025:
3 new regulatory approvals and up to 10 new launch countries in 2025
Geographic Expansion
Recently approved in Australia
Regulatory approvals in Canada and Japan also
anticipated in 2025
ITALY CZECH REPUBLIC SWITZERLAND
CANADA
SWEDEN
AUSTRALIA JAPAN
Combined ~150-200 people 18+ living with LOPD
and being treated with a Pompe therapy
Regulatory
Reimbursement
In 2025, expect to launch in up to 10 new countries,
including 5 recent agreements
>650 LOPD patients 18+ in those 10 countries
First commercial patients from those new launch countries
anticipated over H1 2025
Anticipate >20 individuals switching from clinical trials
or early access programs in new countries in 2025
Combined ~325-375 people 18+ living with LOPD
and being treated with a Pompe therapy
NETHERLANDS |
| 15
Continuing to build the body of evidence to support planned label expansion
Ongoing Clinical Studies
Clinical study in children with late-onset
Pompe disease (LOPD)
Clinical study in children with
infantile-onset Pompe disease (IOPD)
Amicus registry adding to evidence on
differentiated MOA and long-term effect |
| 16
Strong presence at WORLDSymposium demonstrating leadership in Fabry and Pompe diseases
WORLDSymposiumTM 2025
• 2 platform and 20 poster presentations
• Expanding our real-world evidence of
Galafold with high utility
• Further evidence supporting use of
Pombiliti + Opfolda
• Significant conference focus on improving
diagnosis and benefits of early treatment |
| 17
Corporate Outlook
Delivering on our mission for patients
and shareholders |
| 18
FY 2024 Select Financial Results
Q4 Full Year
(in thousands, except per share data) Dec. 31, 2024 Dec. 31, 2023 Dec. 31, 2024 Dec. 31, 2023
Net product sales $ 149,706 $ 115,082 $ 528,295 $ 399,356
Cost of goods sold 14,836 11,324 52,943 37,326
GAAP operating expenses 118,900 107,450 450,476 439,241
Non-GAAP operating expenses 97,641 87,173 347,836 341,574
GAAP net income (loss) 14,739 (33,843) (56,106) (151,584)
Non-GAAP net income (loss) 29,192 2,550 73,884 (38,501)
GAAP net income (loss) per share – basic and
diluted $ 0.05 $ (0.11) $ (0.18) $ (0.51)
Non-GAAP net income (loss) per share - basic $ 0.10 $ 0.01 $ 0.24 $ (0.13)
Non-GAAP net income (loss per share - diluted $ 0.09 $ 0.01 $ 0.24 $ (0.13)
QTD December 31, 2024 basic weighted-average common shares outstanding: 306,136,125; QTD December 31, 2023 weighted-average common shares outstanding: 300,648,503
YTD December 31, 2024, basic weighted-average common shares outstanding: 304,380,502; YTD December 31, 2023, weighted-average common shares outstanding: 295,164,515
FY 2024 revenue of $528M, up 32% and non-GAAP net income of $73.9M |
| 19
Full-Year 2025 Financial Guidance
FY 2025 Financial Guidance1 2025
Total Revenue Growth1 17% to 24%
Galafold Revenue Growth1 10% to 15%
Pombiliti + Opfolda Revenue Growth1 65% to 85%
Gross Margin Mid 80%
Non-GAAP Operating Expense $350M to $370M
GAAP Net Income Positive during H2 2025
1 Full-Year 2025 guidance is provided at CER (Constant Exchange Rates) using Full-Year 2024 Average Exchange Rates
FY 2025 Revenue Sensitivity
Given the proportion of Amicus revenue ex-US
(~60% in 2024), a change in USD exchange
rates of +/- 1% compared to year-end 2024
rates could lead to a ~$4M move in Total
Reported Revenues in 2025 |
| 20
Distribution of Galafold Quarterly Sales
Distribution of Galafold® Revenue by Quarter over Past 5 Years
Q1 Q2 Q3 Q4
5 Year Avg. 22% 24% 26% 28% |
| 21
A unique story in biotech with significant revenue growth and profitability
Two Approved
Therapies
Surpassing $1B
in Total Sales
in 2028 Double-digit
Revenue
Growth
Self-Sustainable
Company and
Growing Free
Cash Flow
Leverageable
Rare Disease
Infrastructure
A Rare Company |
| Appendix |
| 23
Reconciliation of Non-GAAP Financial Measures |
| 24
Reconciliation of Non-GAAP Financial Measures (Cont’d) |
| 25
Exchange Rates
Q4 2024 Currency Average Rates
FX Rates Q4 2023 Q4 2024 Variance
USD/EUR 1.076 1.067 (0.8%)
USD/GBP 1.241 1.282 3.3%
USD/JPY 0.007 0.007 (3.0%)
Year-End 2024 vs. Full-Year 2024 Currency Average Rates1
FX Rates Year-End 2024 Full-Year 2024 Variance
USD/EUR 1.041 1.082 (3.8%)
USD/GBP 1.255 1.278 (1.8%)
USD/JPY 0.006 0.007 (3.5%)
1 The variance between Year-End 2024 and Full-Year 2024 USD exchange rates of ~4% would translate into a
negative impact of ~$15M on Total Revenue in 2025 if rates were to remain at Year-End 2024 level |
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