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 third quarter ended September 30, 2023.
Bradley Campbell, President and Chief Executive
Officer of Amicus Therapeutics, Inc., stated, “This has been a
monumental quarter for Amicus highlighted by the U.S. and U.K.
approvals of Pombiliti and Opfolda, the global launches of
Pombiliti and Opfolda, as well as the continued strong growth of
Galafold worldwide. We are now approved in the three largest Pompe
markets and are making tremendous progress on our second commercial
launch. In addition to the commercial successes, we are well on
track to achieve all of our annual strategic priorities, including
non-GAAP profitability in the fourth quarter. I am proud of
everyone at Amicus who has worked so hard to make a difference in
the lives of people living with rare diseases.”
Recent Corporate
Highlights:
- Total
revenues were $103.5 million in the third quarter
2023, a year-over-year increase of 27%, or 22% at
constant exchange rates (CER)1.
(in thousands) |
Three Months Ended September 30, |
|
Year over Year % Growth |
|
Nine Months Ended September
30, |
|
Year over Year % Growth |
|
|
2023 |
|
|
2022 |
|
Reported |
|
at CER1 |
|
|
2023 |
|
|
2022 |
|
Reported |
|
at CER1 |
Galafold® |
|
100,733 |
|
|
81,631 |
|
23 |
% |
|
19 |
% |
|
|
281,177 |
|
|
241,056 |
|
17 |
% |
|
17 |
% |
Pombiliti™ + Opfolda™ |
|
2,768 |
|
|
60 |
|
n/a |
|
n/a |
|
|
3,097 |
|
|
81 |
|
n/a |
|
n/a |
Net Product Revenues |
$ |
103,501 |
|
$ |
81,691 |
|
27 |
% |
|
22 |
% |
|
$ |
284,274 |
|
$ |
241,137 |
|
18 |
% |
|
18 |
% |
- Galafold
(migalastat) net product sales were $100.7 million in the
third quarter 2023, a year-over-year increase of
23%, or 19% at CER1.
- Pombiliti
(cipaglucosidase alfa-atga) + Opfolda (miglustat) approved in the
U.S., EU, and U.K. The commercial launch of Pombiliti +
Opfolda is successfully underway in the three largest markets. Net
product sales in the third quarter were $2.8 million. Third quarter
revenue represents commercial sales in Germany and the U.K.
- Amicus
entered into a definitive agreement for a $430 million refinancing
collaboration with Blackstone. Blackstone Life Sciences
and Blackstone Credit have agreed to provide Amicus with a $400
million senior secured term loan facilitating a refinancing of
existing debt under more favorable terms and a $30 million
strategic investment in Amicus common stock.
- Full-year
2023 non-GAAP operating expense guidance of $330 million to $350
million, driven by prudent expense management while
investing in Pombiliti + Opfolda manufacturing and launch
activities.
- Based on
the current operating plan, the Company is on-track to achieve
non-GAAP profitability2 in the
fourth quarter of 2023, a major milestone for Amicus.
Third Quarter 2023 Financial
Results
- Total revenue in the third quarter
2023 was $103.5 million, a year-over-year increase of 27% from
total revenue of $81.7 million in the third quarter 2022. On a
constant currency basis, third quarter 2023 total revenue growth
was 22%. Currency impact on reported revenue in the third quarter
of 2023 represented a benefit of $3.8 million, or 5%.
- Total GAAP operating expenses of
$110.6 million for the third quarter 2023 increased by 8% as
compared to $102.1 million for the third quarter 2022.
- Total non-GAAP operating expenses
of $89.8 million for the third quarter 2023 increased by 5% as
compared to $85.5 million for the third quarter 2022.3
- Net loss was reduced to $21.6
million, or $0.07 per share for the third quarter 2023, compared to
a net loss of $33.3 million, or $0.12 per share, for the third
quarter 2022.
- Cash, cash equivalents, and
marketable securities totaled $280.3 million at September 30, 2023,
compared to $293.6 million at December 31, 2022.
2023 Financial Guidance
- For the full-year 2023, the Company
is increasing the Galafold revenue growth guidance to between 16
and 18% at CER1 driven by several factors including continued
strong underlying demand from both switch and treatment-naïve
patients, further geographic expansion and label extensions, the
continued diagnosis of new Fabry patients, and commercial execution
across all major markets, including the U.S., EU, U.K., and
Japan.
- Non-GAAP operating expense guidance
for the full-year 2023 is $330 million to $350 million, driven by
prudent expense management offset by continued investment in
Galafold, AT-GAA clinical studies, non-recurring costs for
manufacturing as well as global launch activities4.
- The Company is on-track to achieve
non-GAAP profitability2 in the fourth quarter of 2023.
Amicus is focused on the following five key strategic
priorities in 2023:
- Sustain double-digit Galafold
revenue growth (16-18% at CER1)
- Secure EMA, MHRA, and FDA approvals
for Pombiliti + Opfolda
- Initiate successful global launches
of Pombiliti + Opfolda
- Advance next-generation pipeline
programs (Fabry GTx, Fabry Next-Generation Chaperone, Pompe
GTx)
- Maintain strong financial position
on path to profitability
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. Full-year 2023 Galafold revenue guidance utilizes the
actual exchange rates at December 31, 2022.2 Based on projections
of Amicus’ non-GAAP Net Income under current operating plans.
Amicus defines non-GAAP Net Income as GAAP Net Income excluding the
impact of stock-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.3 Full reconciliation of GAAP results to the
Company’s non-GAAP adjusted measures for all reporting periods
appears in the tables to this press release.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, November 8, 2023, at 8:30 a.m. ET to
discuss the third quarter 2023 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 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 Fabry
patients 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 USAGEGalafold 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 REACTIONSThe most common adverse drug
reactions reported with Galafold (≥10 %) are headache,
nasopharyngitis, urinary tract infection, nausea, and pyrexia.
DRUG INTERACTIONSAvoid co-administration of
Galafold with caffeine at least 2 hours before and 2 hours after
taking Galafold.
USE IN SPECIFIC POPULATIONSThere 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 Therapeutic
IndicationGalafold® (migalastat) is indicated for
long-term treatment of adults and adolescents aged 12 years and
older with a confirmed diagnosis of Fabry disease (α-galactosidase
A deficiency) and who have an amenable mutation.
EU Important Safety
InformationTreatment with Galafold should be initiated and
supervised by specialist physicians experienced in the diagnosis
and treatment of Fabry disease. Galafold is not intended for
concomitant use with enzyme replacement therapy.
The safety and efficacy of Galafold in children
aged less than 12 years have not been established. No data are
available.
Galafold is contraindicated in patients with
hypersensitivity to the active substance or to any of the
excipients listed in the Summary of Product Characteristics
(SmPC).
Galafold 123 mg capsules are not for children
(≥12 years) weighing less than 45 kg.
It is advised to periodically monitor renal
function, echocardiographic parameters and biochemical markers
(every 6 months) in patients initiated on or switched to Galafold.
In case of meaningful clinical deterioration, further clinical
evaluation or discontinuation of treatment with Galafold should be
considered.
Galafold is not indicated for use in patients
with non-amenable mutations.
Galafold is not recommended for use in patients
with severe renal insufficiency, defined as estimated GRF less than
30 mL/min/1.73m2.
Food and caffeine should not be consumed at
least 2 hours before and 2 hours after taking Galafold to give a
minimum 4 hours fast.
Galafold is not recommended in women of
childbearing potential not using contraception. Galafold is not
recommended during pregnancy. It is not known whether Galafold is
secreted in human milk.
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 SmPC.
OVERDOSE: General medical care is recommended in the case of
Galafold overdose.
For complete information please see the EU SmPC available at
https://www.ema.europa.eu/en/medicines/human/EPAR/galafold
About Pombiliti +
OpfoldaPombiliti + 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
USAGEPOMBILITI 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.
EU Important Safety
InformationPombiliti (cipaglucosidase alfa)
Important Safety Information
Posology and Method of
Administration: Pombiliti must be used in combination with
miglustat 65 mg hard capsules. The recommended dose of Pombiliti is
20 mg/kg of body weight every other week. The Pombiliti infusion
should start 1 hour after taking miglustat capsules.
Paediatric population: The safety and efficacy of
Pombiliti in combination with miglustat therapy in paediatric
patients less than 18 years old have not yet been established. No
data are available.
Contraindications:
Life-threatening hypersensitivity to the active substance, or to
any of the excipients. Contraindication to miglustat.
Anaphylaxis and infusion-associated reactions
(IARs): Serious anaphylaxis and IARs have occurred in some
patients during infusion and following infusion with Pombiliti.
Premedication with oral antihistamine, antipyretics, and/or
corticosteroids may be administered to assist with signs and
symptoms related to IARs experienced with prior enzyme replacement
therapy (ERT) treatment. Reduction of the infusion rate, temporary
interruption of the infusion, symptomatic treatment with oral
antihistamine, or antipyretics, and appropriate resuscitation
measures should be considered to manage serious IARs. If
anaphylaxis or severe allergic reactions occur, infusion should be
immediately paused, and appropriate medical treatment should be
initiated. The current medical standards for emergency treatment of
anaphylactic reactions are to be observed and cardiopulmonary
resuscitation equipment should be readily available. The risks and
benefits of re-administering Pombiliti following anaphylaxis or
severe allergic reaction should be carefully considered, and
appropriate resuscitation measures made available. Risk of
acute cardiorespiratory failure in susceptible patients:
Patients with acute underlying respiratory illness or compromised
cardiac and/or respiratory function may be at risk of serious
exacerbation of their cardiac or respiratory compromise during
infusions. Appropriate medical support and monitoring measures
should be readily available during Pombiliti infusion.
Immune complex-related reactions: Immune
complex-related reactions have been reported with other ERTs in
patients who had high IgG antibody titres, including severe
cutaneous reactions and nephrotic syndrome. If immune
complex-related reactions occur, discontinuation of the
administration of Pombiliti should be considered and appropriate
medical treatment should be initiated. The risks and benefits of
re-administering Pombiliti following an immune complex-related
reaction should be reconsidered for each individual patient.
Contraception in females: Reliable contraceptive
measures must be used by women of childbearing potential during
treatment with Pombiliti in combination with miglustat, and for 4
weeks after discontinuing treatment. Pregnancy:
Pombiliti in combination with miglustat therapy is not recommended
during pregnancy. Breast feeding: It is not known
if Pombiliti and miglustat are secreted in human breast milk. A
decision must be made whether to discontinue breast-feeding or to
discontinue/abstain from Pombiliti in combination with miglustat
therapy, taking into account the benefit of breast-feeding for the
child and the benefit of therapy for the woman. Summary of
the safety profile: The most commonly reported adverse
reactions only attributable to Pombiliti were chills (4.0%),
dizziness (2.6%), flushing (2.0%), somnolence (2.0%), chest
discomfort (1.3%), cough, (1.3%), infusion site swelling (1.3%),
and pain (1.3%). Reported serious adverse reactions only
attributable to Pombiliti were urticaria (2.0%), anaphylaxis
(1.3%), pyrexia (0.7%), presyncope (0.7%), dyspnoea (0.7%),
pharyngeal oedema (0.7%), wheezing (0.7%), and hypotension (0.7%).
Refer to SmPC for full list.
Opfolda (miglustat) 65 mg hard capsules
Important Safety Information
Posology and Method of
Administration: Opfolda must be used in combination with
Pombiliti. The recommended dose is to be taken orally every other
week and is based on body weight. Opfolda should be taken
approximately 1 hour but no more than 3 hours before the start of
the Pombiliti infusion. Paediatric population: The
safety and efficacy of Opfolda in combination with Pombiliti
therapy in paediatric patients less than 18 years old have not yet
been established. No data are available.
Contraindications: Hypersensitivity to the active
substance or to any of the excipients. Contraindication to
cipaglucosidase alfa. Food Interaction: Patients
should fast for 2 hours before and 2 hours after taking Opfolda.
Contraception in females: Reliable contraceptive
measures must be used by women of childbearing potential during
treatment with Opfolda in combination with Pombiliti, and for 4
weeks after discontinuing treatment. Pregnancy:
Opfolda crosses the placenta. Opfolda in combination with Pombiliti
therapy is not recommended during pregnancy. Breast
feeding: It is not known if Opfolda and Pombiliti are
secreted in human breast milk. A decision must be made whether to
discontinue breast-feeding or to discontinue/abstain from Opfolda
in combination with Pombiliti therapy, taking into account the
benefit of breastfeeding for the child and the benefit of therapy
for the woman. Summary of the safety profile: The
most commonly reported adverse reaction only attributable to
Opfolda 65 mg was constipation (1.3%). Refer to SmPC for full
list.
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 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. 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 StatementThis
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, 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, MHRA, and PMDA, 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 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 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,
2022, and on Form 10-Q for the quarter ended September 30, 2023, 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
FaughnanVice President, Investor
Relationsafaughnan@amicusrx.com(609) 662-3809
Media: Amicus Therapeutics Diana Moore Head 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 September 30, |
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net product sales |
$ |
103,501 |
|
|
$ |
81,691 |
|
|
$ |
284,274 |
|
|
$ |
241,137 |
|
Cost of goods sold |
|
9,946 |
|
|
|
13,436 |
|
|
|
26,002 |
|
|
|
29,215 |
|
Gross profit |
|
93,555 |
|
|
|
68,255 |
|
|
|
258,272 |
|
|
|
211,922 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
40,704 |
|
|
|
52,970 |
|
|
|
117,352 |
|
|
|
212,806 |
|
Selling, general, and administrative |
|
65,651 |
|
|
|
47,272 |
|
|
|
205,031 |
|
|
|
158,767 |
|
Changes in fair value of contingent consideration payable |
|
1,995 |
|
|
|
567 |
|
|
|
2,583 |
|
|
|
(506 |
) |
Loss on impairment of assets |
|
— |
|
|
|
— |
|
|
|
1,134 |
|
|
|
6,616 |
|
Depreciation and amortization |
|
2,228 |
|
|
|
1,286 |
|
|
|
5,691 |
|
|
|
4,031 |
|
Total operating expenses |
|
110,578 |
|
|
|
102,095 |
|
|
|
331,791 |
|
|
|
381,714 |
|
Loss from operations |
|
(17,023 |
) |
|
|
(33,840 |
) |
|
|
(73,519 |
) |
|
|
(169,792 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
1,471 |
|
|
|
563 |
|
|
|
5,407 |
|
|
|
1,052 |
|
Interest expense |
|
(12,986 |
) |
|
|
(9,620 |
) |
|
|
(37,322 |
) |
|
|
(26,024 |
) |
Other income (expense) |
|
3,833 |
|
|
|
13,634 |
|
|
|
(13,007 |
) |
|
|
22,804 |
|
Loss before income tax |
|
(24,705 |
) |
|
|
(29,263 |
) |
|
|
(118,441 |
) |
|
|
(171,960 |
) |
Income tax benefit
(expense) |
|
3,128 |
|
|
|
(4,023 |
) |
|
|
700 |
|
|
|
(8,743 |
) |
Net loss attributable
to common stockholders |
$ |
(21,577 |
) |
|
$ |
(33,286 |
) |
|
$ |
(117,741 |
) |
|
$ |
(180,703 |
) |
Net loss attributable to
common stockholders per common share — basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.63 |
) |
Weighted-average common shares
outstanding — basic and diluted |
|
295,759,435 |
|
|
|
289,223,709 |
|
|
|
293,314,167 |
|
|
|
288,841,092 |
|
TABLE 2
Amicus
Therapeutics, Inc.Consolidated Balance
Sheets(Unaudited)(in thousands,
except share and per share amounts)
|
September 30, 2023 |
|
December 31, 2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
263,320 |
|
|
$ |
148,813 |
|
Investments in marketable securities |
|
16,980 |
|
|
|
144,782 |
|
Accounts receivable |
|
73,331 |
|
|
|
66,196 |
|
Inventories |
|
56,936 |
|
|
|
23,816 |
|
Prepaid expenses and other current assets |
|
52,689 |
|
|
|
40,209 |
|
Total current assets |
|
463,256 |
|
|
|
423,816 |
|
Operating lease right-of-use assets, net |
|
29,511 |
|
|
|
29,534 |
|
Property and equipment, less accumulated depreciation of $25,018
and $22,281 at September 30, 2023 and December 31, 2022,
respectively |
|
31,072 |
|
|
|
30,778 |
|
Intangible assets, less accumulated amortization of $1,682 and $0
at September 30, 2023 and December 31, 2022, respectively |
|
21,318 |
|
|
|
23,000 |
|
Goodwill |
|
197,797 |
|
|
|
197,797 |
|
Other non-current assets |
|
21,130 |
|
|
|
19,242 |
|
Total
Assets |
$ |
764,084 |
|
|
$ |
724,167 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
23,154 |
|
|
$ |
15,413 |
|
Accrued expenses and other current liabilities |
|
138,535 |
|
|
|
93,636 |
|
Contingent consideration payable |
|
— |
|
|
|
21,417 |
|
Operating lease liabilities |
|
7,765 |
|
|
|
8,552 |
|
Total current liabilities |
|
169,454 |
|
|
|
139,018 |
|
Long-term debt |
|
394,071 |
|
|
|
391,990 |
|
Operating lease liabilities |
|
52,454 |
|
|
|
51,578 |
|
Deferred reimbursements |
|
5,906 |
|
|
|
4,656 |
|
Deferred income taxes |
|
— |
|
|
|
4,939 |
|
Other non-current liabilities |
|
8,962 |
|
|
|
8,939 |
|
Total liabilities |
|
630,847 |
|
|
|
601,120 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Common stock, $0.01 par value,
500,000,000 shares authorized, 290,667,041 and 281,108,273 shares
issued and outstanding at September 30, 2023 and December 31, 2022,
respectively |
|
2,890 |
|
|
|
2,815 |
|
Additional paid-in
capital |
|
2,787,275 |
|
|
|
2,664,744 |
|
Accumulated other
comprehensive loss: |
|
|
|
Foreign currency translation adjustment |
|
(6,573 |
) |
|
|
(11,989 |
) |
Unrealized loss on available-for-sale securities |
|
(195 |
) |
|
|
(116 |
) |
Warrants |
|
71 |
|
|
|
83 |
|
Accumulated deficit |
|
(2,650,231 |
) |
|
|
(2,532,490 |
) |
Total stockholders’
equity |
|
133,237 |
|
|
|
123,047 |
|
Total Liabilities and
Stockholders’ Equity |
$ |
764,084 |
|
|
$ |
724,167 |
|
TABLE 3
Amicus
Therapeutics, Inc.Reconciliation of Non-GAAP
Financial Measures(in thousands)
|
Three Months Ended September
30, |
|
Nine Months Ended September
30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Total operating
expenses - as reported GAAP |
$ |
110,578 |
|
$ |
102,095 |
|
$ |
331,791 |
|
$ |
381,714 |
|
Research and development: |
|
|
|
|
|
|
|
Stock-based compensation |
|
4,380 |
|
|
5,428 |
|
|
16,987 |
|
|
19,172 |
|
Selling, general and administrative: |
|
|
|
|
|
|
|
Stock-based compensation |
|
12,131 |
|
|
9,344 |
|
|
50,995 |
|
|
38,714 |
|
Loss on impairment of assets |
|
— |
|
|
— |
|
|
1,134 |
|
|
6,616 |
|
Changes in fair value of contingent consideration
payable |
|
1,995 |
|
|
567 |
|
|
2,583 |
|
|
(506 |
) |
Depreciation and amortization |
|
2,228 |
|
|
1,286 |
|
|
5,691 |
|
|
4,031 |
|
Total operating
expense adjustments to reported GAAP |
|
20,734 |
|
|
16,625 |
|
|
77,390 |
|
|
68,027 |
|
Total operating expenses - as adjusted |
$ |
89,844 |
|
$ |
85,470 |
|
$ |
254,401 |
|
$ |
313,687 |
|
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