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 second quarter ended June 30, 2023.
Bradley Campbell, President and Chief Executive
Officer of Amicus Therapeutics, Inc., stated, “Amicus has made
tremendous progress through the first half of 2023, highlighted by
the strong growth of Galafold and the regulatory approval of
Pombiliti and Opfolda in the EU. We are confident in our trajectory
towards delivering on our core objectives this year, including the
continued growth of Galafold and the anticipated approvals of
Pombiliti and Opfolda in the U.S. and U.K. this quarter. I am also
very pleased to share we have revised our revenue guidance upwards
and are reducing operating expense guidance for the year further
supporting our path to non-GAAP profitability. Amicus is well
positioned to deliver sustainable value for our shareholders while
advancing our mission to deliver great medicines for people living
with rare diseases.”
Corporate Highlights:
- Global
revenue in the second quarter 2023 was $94.5 million.
Second quarter revenue represented a year-over-year increase of 17%
from total revenue of $80.7 million in the second quarter 2022.
Second quarter performance reflected a strong operational revenue
growth of 17% measured at constant exchange rates (CER)1 and a
negligible currency impact of $0.2 million, or 0%.
- Global
revenue in the first half 2023 was $180.8 million. First
half revenue represented a year-over-year increase of 13% from
total revenue of $159.4 million in the first half 2022. First half
performance reflected a strong operational revenue growth of 16%
measured at constant exchange rates (CER)1 and a negative currency
impact of $4.1 million, or 3%.
(in thousands) |
Three Months Ended June 30, |
|
Year over Year % Growth |
|
Six Months Ended June 30, |
|
Year over Year % Growth |
|
2023 |
|
2022 |
|
As Reported |
|
at CER1 |
|
2023 |
|
2022 |
|
As Reported |
|
at CER1 |
Net Product Revenues |
$94,503 |
|
$80,731 |
|
17% |
|
17% |
|
$180,773 |
|
$159,446 |
|
13% |
|
16% |
- Given
strong operational performance in the first half of 2023, the
Company now anticipates Galafold®
revenue growth of 14-18% at CER1
for the full-year 2023. Growth is expected to be
driven by continued underlying demand from both switch and
treatment-naïve patients, geographic expansion, label extensions,
continued diagnosis of new Fabry patients, and commercial execution
across all major markets, including the U.S., EU, U.K., and
Japan.
- Commercial
launch of Pombiliti®
(cipaglucosidase alfa) +
Opfolda®
(miglustat) underway in the EU. In the EU, the
European Commission granted full approval of Pombiliti + Opfolda
for the treatment of adults with late-onset Pompe disease (LOPD).
The Company has initiated the commercial launch of Pombiliti +
Opfolda in Germany and reimbursement discussions with healthcare
authorities in additional European countries are underway.
- U.S. and
U.K. regulatory reviews of AT-GAA remain on-track. The
Company continues to expect regulatory approvals of AT-GAA in both
the U.S. and U.K. in the third quarter of 2023.
- Galafold
U.S. intellectual property estate further strengthened following
the issuance of multiple new patents in 2023. Galafold is
protected by orphan drug regulatory exclusivities and a broad U.S.
intellectual property portfolio of 53 orange book-listed patents,
including 9 composition of matter patents, 37 of which provide
protection through 2038 and beyond.
- Full-year
2023 non-GAAP operating expense guidance reduced to $330 million to
$350 million, driven by prudent expense management while
investing in AT-GAA manufacturing and launch activities.
- Based on
the current operating plan and the timing of AT-GAA approvals, the
Company is on-track to achieve non-GAAP
profitability2 in the second half
of 2023.
- Amicus
announces retirement of Chief Financial Officer, Daphne
Quimi. After 15 years of distinguished leadership at
Amicus, Daphne Quimi has decided to retire. Ms. Quimi will remain
in her role as CFO until her successor is appointed and will remain
with Amicus through the end of the year in order to support a
smooth transition.
Second Quarter 2023 Financial
Results
- Total revenue in the second quarter
2023 was $94.5 million, a year-over-year increase of 17% from total
revenue of $80.7 million in the second quarter 2022. On a constant
currency basis, second quarter 2023 total revenue growth was 17%.
Currency impact on reported revenue in the second quarter of 2023
represented a negligible amount of $0.2 million, or 0%.
- Total GAAP operating expenses of
$104.2 million for the second quarter 2023 decreased as compared to
$133.1 million for the second quarter 2022.
- Total non-GAAP operating expenses
of $84.0 million for the second quarter 2023 decreased as compared
to $119.2 million for the second quarter 2022, primarily reflecting
decreased program spend.3
- Net loss was $43.2 million, or
$0.15 per share in the second quarter 2023, and was reduced
compared to a net loss of $62.2 million, or $0.21 per share, for
the second quarter 2022.
- Cash, cash equivalents, and
marketable securities totaled $265.6 million at June 30, 2023,
compared to $293.6 million at December 31, 2022.
2023 Financial Guidance
- For the full-year 2023, the Company
now anticipates total Galafold revenue growth between 14 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.
- Amicus is reducing its non-GAAP
operating expense guidance for the full-year 2023 to $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 second half of 2023.
Amicus is focused on the following five key strategic
priorities in 2023:
- Sustain double-digit Galafold
revenue growth (14-18% 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, which
includes successful AT-GAA regulatory approvals and continued
Galafold growth. Amicus defines non-GAAP Net Income as GAAP Net
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.3 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.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
WebcastAmicus Therapeutics will host a conference
call and audio webcast today, August 8, 2023, at 8:30 a.m. ET to
discuss the second 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%) were headache,
nasopharyngitis, urinary tract infection, nausea and pyrexia.
DRUG INTERACTIONS Avoid 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® +
Opfolda®Pombiliti + Opfolda, is a
two-component therapy that consists of cipaglucosidase alfa, 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. In clinical studies, Pombiliti +
Opfolda was associated with demonstrated improvements in both
musculoskeletal and respiratory measures.
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 in
Europe, Japan, the US and other geographies or AT-GAA if and when
approved; the potential that preclinical and clinical studies could
be delayed because we identify serious side effects or other safety
issues; the potential that we may not be able to manufacture or
supply sufficient clinical or commercial products; and the
potential that we will need additional funding to complete all of
our studies and manufacturing. Further, the results of earlier
preclinical studies and/or clinical trials may not be predictive of
future results. Statements regarding corporate financial guidance
and financial goals and the attainment of such goals. With respect
to statements regarding projections of the Company's revenue and
cash position, actual results may differ based on market factors
and the Company's ability to execute its operational and budget
plans. In addition, all forward-looking statements are subject to
other risks detailed in our Annual Report on Form 10-K for the year
ended December 31, 2022, and on Form 10-Q for the quarter ended
June 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 Faughnan
Vice President, Investor
Relations afaughnan@amicusrx.com (609) 662-3809
Media: Amicus Therapeutics Diana Moore Head of
Global Corporate Communications dmoore@amicusrx.com (609)
662-5079
FOLD-G
TABLE
1 |
Amicus Therapeutics, Inc. |
Consolidated Statements of Operations |
(Unaudited) |
(in thousands, except share and per share
amounts) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Net product sales |
$ |
94,503 |
|
|
$ |
80,731 |
|
|
$ |
180,773 |
|
|
$ |
159,446 |
|
Cost of goods sold |
|
9,114 |
|
|
|
8,197 |
|
|
|
16,056 |
|
|
|
15,779 |
|
Gross profit |
|
85,389 |
|
|
|
72,534 |
|
|
|
164,717 |
|
|
|
143,667 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
35,149 |
|
|
|
78,319 |
|
|
|
76,648 |
|
|
|
159,836 |
|
Selling, general, and administrative |
|
65,423 |
|
|
|
53,379 |
|
|
|
139,380 |
|
|
|
111,495 |
|
Changes in fair value of contingent consideration payable |
|
337 |
|
|
|
115 |
|
|
|
588 |
|
|
|
(1,073 |
) |
Loss on impairment of assets |
|
1,134 |
|
|
|
— |
|
|
|
1,134 |
|
|
|
6,616 |
|
Depreciation and amortization |
|
2,206 |
|
|
|
1,334 |
|
|
|
3,463 |
|
|
|
2,745 |
|
Total operating expenses |
|
104,249 |
|
|
|
133,147 |
|
|
|
221,213 |
|
|
|
279,619 |
|
Loss from operations |
|
(18,860 |
) |
|
|
(60,613 |
) |
|
|
(56,496 |
) |
|
|
(135,952 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
Interest income |
|
1,737 |
|
|
|
356 |
|
|
|
3,936 |
|
|
|
489 |
|
Interest expense |
|
(12,492 |
) |
|
|
(8,257 |
) |
|
|
(24,336 |
) |
|
|
(16,404 |
) |
Other (expense) income |
|
(10,902 |
) |
|
|
7,268 |
|
|
|
(16,840 |
) |
|
|
9,170 |
|
Loss before income tax |
|
(40,517 |
) |
|
|
(61,246 |
) |
|
|
(93,736 |
) |
|
|
(142,697 |
) |
Income tax expense |
|
(2,715 |
) |
|
|
(911 |
) |
|
|
(2,428 |
) |
|
|
(4,720 |
) |
Net loss attributable
to common stockholders |
$ |
(43,232 |
) |
|
$ |
(62,157 |
) |
|
$ |
(96,164 |
) |
|
$ |
(147,417 |
) |
Net loss attributable to
common stockholders per common share — basic and diluted |
$ |
(0.15 |
) |
|
$ |
(0.21 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.51 |
) |
Weighted-average common shares
outstanding — basic and diluted |
|
292,797,002 |
|
|
|
291,970,562 |
|
|
|
292,071,201 |
|
|
|
288,646,587 |
|
TABLE
2 |
Amicus Therapeutics, Inc. |
Consolidated Balance Sheets |
(Unaudited) |
(in thousands, except share and per share
amounts) |
|
|
June 30, |
|
December 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
211,307 |
|
|
$ |
148,813 |
|
Investments in marketable securities |
|
54,319 |
|
|
|
144,782 |
|
Accounts receivable |
|
63,716 |
|
|
|
66,196 |
|
Inventories |
|
51,381 |
|
|
|
23,816 |
|
Prepaid expenses and other current assets |
|
52,099 |
|
|
|
40,209 |
|
Total current assets |
|
432,822 |
|
|
|
423,816 |
|
Operating lease right-of-use assets, net |
|
28,042 |
|
|
|
29,534 |
|
Property and equipment, less accumulated depreciation of $24,060
and $22,281 at June 30, 2023 and December 31, 2022,
respectively |
|
30,238 |
|
|
|
30,778 |
|
Intangible asset, less accumulated depreciation of $855 and $0 at
June 30, 2023 and December 31, 2022, respectively |
|
22,145 |
|
|
|
23,000 |
|
Goodwill |
|
197,797 |
|
|
|
197,797 |
|
Other non-current assets |
|
19,049 |
|
|
|
19,242 |
|
Total
Assets |
$ |
730,093 |
|
|
$ |
724,167 |
|
Liabilities and
Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
13,522 |
|
|
$ |
15,413 |
|
Accrued expenses and other current liabilities |
|
124,868 |
|
|
|
93,636 |
|
Contingent consideration payable |
|
13,005 |
|
|
|
21,417 |
|
Operating lease liabilities |
|
7,840 |
|
|
|
8,552 |
|
Total current liabilities |
|
159,235 |
|
|
|
139,018 |
|
Long-term debt |
|
393,350 |
|
|
|
391,990 |
|
Operating lease liabilities |
|
50,976 |
|
|
|
51,578 |
|
Deferred reimbursements |
|
5,906 |
|
|
|
4,656 |
|
Deferred income taxes |
|
— |
|
|
|
4,939 |
|
Other non-current liabilities |
|
9,045 |
|
|
|
8,939 |
|
Total liabilities |
|
618,512 |
|
|
|
601,120 |
|
Commitments and
contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Common stock, $0.01 par value,
500,000,000 shares authorized, 286,992,923 and 281,108,273 shares
issued and outstanding at June 30, 2023 and December 31, 2022,
respectively |
|
2,856 |
|
|
|
2,815 |
|
Additional paid-in
capital |
|
2,733,148 |
|
|
|
2,664,744 |
|
Accumulated other
comprehensive gain (loss): |
|
|
|
Foreign currency translation adjustment |
|
4,337 |
|
|
|
(11,989 |
) |
Unrealized loss on available-for-sale securities |
|
(177 |
) |
|
|
(116 |
) |
Warrants |
|
71 |
|
|
|
83 |
|
Accumulated deficit |
|
(2,628,654 |
) |
|
|
(2,532,490 |
) |
Total stockholders'
equity |
|
111,581 |
|
|
|
123,047 |
|
Total Liabilities and
Stockholders' Equity |
$ |
730,093 |
|
|
$ |
724,167 |
|
TABLE
3 |
Amicus Therapeutics, Inc. |
Reconciliation of Non-GAAP Financial Measures |
(in thousands) |
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Total operating expenses - as reported GAAP |
$ |
104,249 |
|
|
$ |
133,147 |
|
|
$ |
221,213 |
|
|
$ |
279,619 |
|
Research and development: |
|
|
|
|
|
|
|
Stock-based compensation |
|
4,117 |
|
|
|
4,379 |
|
|
|
12,607 |
|
|
|
13,744 |
|
Selling, general and administrative: |
|
|
|
|
|
|
|
Stock-based compensation |
|
12,460 |
|
|
|
8,084 |
|
|
|
38,864 |
|
|
|
29,370 |
|
Loss on impairment of assets |
|
1,134 |
|
|
|
- |
|
|
|
1,134 |
|
|
|
6,616 |
|
Changes in fair value of contingent consideration
payable |
|
337 |
|
|
|
115 |
|
|
|
588 |
|
|
|
(1,073 |
) |
Depreciation and amortization |
|
2,206 |
|
|
|
1,334 |
|
|
|
3,463 |
|
|
|
2,745 |
|
Total operating expense adjustments to reported
GAAP |
|
20,254 |
|
|
|
13,912 |
|
|
|
56,656 |
|
|
|
51,402 |
|
Total operating expenses - as adjusted |
$ |
83,995 |
|
|
$ |
119,235 |
|
|
$ |
164,557 |
|
|
$ |
228,217 |
|
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