Amicus Therapeutics (Nasdaq: FOLD), a global, patient-dedicated
biotechnology company focused on discovering, developing and
delivering novel medicines for rare diseases, today announced
financial results for the second quarter ended June 30, 2020. The
Company also summarized recent program updates and reiterated its
full-year 2020 guidance.
John F. Crowley, Chairman and Chief Executive
Officer of Amicus Therapeutics, Inc., stated, “During the second
quarter, we made tremendous progress advancing our mission for
patients and are on track to achieve our 2020 key strategic
priorities, including our global Fabry launch, Pompe late-stage
development program, and advancing our industry-leading gene
therapy pipeline. Following our strategic financing in July, Amicus
is firmly on a path to profitability without the need to access the
equity markets. Through these efforts, we remain strongly
positioned to achieve our vision of delivering groundbreaking new
medicines and hopefully, one day, cures for people living with rare
diseases.”
Corporate Highlights
- Global revenue for Galafold® (migalastat) in the second
quarter of 2020 was $62.4M. Second quarter revenue
represented a year-over-year increase of 41% from total revenue of
$44.1 million in the second quarter of 2019. On a constant currency
basis, second quarter 2020 total revenue was $63.3 million,
representing operational revenue growth measured at constant
currency exchange rates of 43%, which was offset by a negative
currency impact of $1.0 million, or 2%.
- Strong second quarter revenue represents the continued
performance across the global business, including new patient
starts from switch and naïve patients throughout the quarter in all
major regions, including that hardest hit by COVID-19.
Performance driven largely by strong patient demand. Global
compliance and adherence rates continue to exceed 90%.
- 1,000+ mutations added to the EU Galafold
label. This update includes a number of new
mutations identified by creating and testing all possible
single-base pair point mutations in the GLA gene. Including this
list will help physicians assess treatment options in an
expeditious manner. Amenable mutations continue to represent
up to half of all people living with Fabry disease.
- Global Phase 3 PROPEL clinical study of AT-GAA in
late-onset Pompe disease (LOPD) remains on track for top line data
in 1H21. To date, 97%+ of the 2,810 planned infusions and
assessments for the ongoing PROPEL study have been completed on
schedule. The Company plans to initiate a rolling BLA for AT-GAA in
the second half of 2020, completing final submission in the first
half of 2021.
- Expanded Access Program for infantile-onset Pompe
patients underway. Amicus has initiated an expanded access
program for its investigational medicine AT-GAA for young children
living with infantile-onset Pompe disease (IOPD).
- Additional Phase 1/2 CLN6 data to be presented this
year at the Child Neurology Society Annual Meeting in
October. Regulatory interactions are ongoing and the
Company expects to provide feedback on the path forward in early
2021.
- Initial data from the Phase 1/2 CLN3 study expected in
early 2021 based on changes in medical conference
schedules. Regulatory interactions are ongoing and
concurrent with the data, the Company expects to provide feedback
on the regulatory pathway.
- Positive preclinical Pompe gene therapy data presented
at American Society of Cell and Gene Therapy meeting in
May. Positive results showed the Amicus engineered hGAA
having better targeting and clearance of glycogen storage in Pompe
mice. Preliminary data in non-human primates suggested
therapeutically relevant expression levels in target organs.
- Cash position sufficient to achieve self-sustainability
without the need for any future dilutive financings. The
previously announced debt facility places Amicus firmly on a path
to profitability, while the Company continues to carefully manage
expenses and investments, while executing on the Galafold launch
and advancing development programs.
2020 Key Strategic
Priorities
- Achieve $250 million to $260 million of global product revenue
for Galafold
- Complete Pompe Phase 3 PROPEL study, enroll pediatric studies
and advance manufacturing to support 2021 BLA and MAA
- Advance clinical development, manufacturing and regulatory
discussions for CLN6 and CLN3 Batten programs
- Progress Pompe gene therapy towards Investigational New Drug
(IND) application and disclose up to two additional IND
candidates
- Maintain strong financial position
Second Quarter 2020 Financial
Results
- Total revenue in the second quarter 2020 was $62.4 million, a
year-over-year increase of 41% from total revenue of $44.1 million
in the second quarter of 2019. On a constant currency basis, second
quarter 2020 total revenue was $63.3 million, representing
operational revenue growth measured at constant currency exchange
rates of 43%, which was offset by a negative currency impact of
$1.0 million, or 2%.
- Cash, cash equivalents, and marketable securities totaled
$309.6 million at June 30, 2020, compared to $452.7 million at
December 31, 2019.
- Total GAAP operating expenses of $107.0 million for the second
quarter 2020 decreased as compared to $115.2 million for the second
quarter 2019, reflecting decreased travel and third-party costs,
offset by continued investments in our gene therapy pipeline.
- Total non-GAAP operating expenses of $95.9 million for the
second quarter of 2020 decreased as compared to $103.6 million in
the second quarter of 2019, reflecting decreased travel and
third-party costs, offset by continued investments in our gene
therapy pipeline.1
- Net loss was $52.5 million, or $0.20 per share, compared to a
net loss of $84.6 million, or $0.36 per share, for the second
quarter 2019.
1 Full reconciliation of GAAP results to the
Company’s non-GAAP adjusted measures for all reporting periods
appear in the tables to this press release.
2020 Financial Guidance
- For the full-year 2020, the Company anticipates total Galafold
revenue of $250 million to $260 million based on the average
exchange rates for 2019.
- Non-GAAP operating expense guidance for the full-year 2020 is
$410 million to $420 million, driven by continued investment in the
global Galafold launch, AT-GAA clinical studies, and advancing our
gene therapy pipeline.2
- Cash, cash equivalents, and marketable securities totaled
$309.6 million at June 30, 2020. Based on current operating models,
the Company believes that the current cash position, along with the
net proceeds from the 2020 Senior Secured Term Loan and expected
revenues, is sufficient to fund the Company’s operations and
ongoing research programs through to profitability.
2 A reconciliation of the differences between
the non-GAAP expectation and the corresponding GAAP measure is not
available without unreasonable effort due to high variability,
complexity and low visibility as to the items that would be
excluded from the GAAP measure.
Anticipated 2020 Milestones by
Program
Galafold (migalastat) Oral Precision
Medicine for Fabry Disease
- On track to meet full-year 2020 revenue guidance range of $250
million to $260 million
- Continued geographic expansion
- Registry and other Phase 4 studies underway
AT-GAA for Pompe Disease
- Plans to initiate a Rolling Biologics License Application (BLA)
for AT-GAA in 2020, with addition of complete clinical results for
PROPEL in 1H2021 to support full approval
- Retrospective natural history study data in approximately 100
Pompe Patients treated with enzyme replacement therapy
- Additional supportive studies, including an open-label study in
12- to <18-year-olds living with Pompe
Gene Therapy Portfolio
- Report further safety and efficacy data in the CLN6 Batten
disease Phase 1/2 study and advance regulatory discussions to
finalize clinical and regulatory path
- Initial data from the CLN3 Batten disease Phase 1/2 study
expected in early 2021 and advance regulatory discussions to
finalize clinical and regulatory path
- Continue IND-enabling toxicology work in Pompe disease and
progress towards IND
- Additional preclinical data expected across multiple programs
with disclosure of up to two additional IND candidates
- Manufacturing advancements across portfolio
Conference Call and
WebcastAmicus Therapeutics will host a conference call and
audio webcast today, August 10, 2020 at 8:30 a.m. ET to discuss the
second quarter 2020 financial results and corporate updates.
Interested participants and investors may access the conference
call by dialing 877-303-5859 (U.S./Canada) or 678-224-7784
(international), conference ID: 4949075.
A live audio webcast and related presentation
materials can also be accessed via the Investors section of the
Amicus Therapeutics corporate website at ir.amicusrx.com. Web
participants are encouraged to register on the website 15 minutes
prior to the start of the call. A replay of the call will be
available for seven days beginning at 11:30 a.m. ET on August 10,
2020. Access numbers for this replay are 855-859-2056 (U.S./Canada)
and 404-537-3406 (international); conference ID: 4949075.
About Galafold
Galafold® (migalastat) 123 mg capsules is an oral
pharmacological chaperone of alpha-Galactosidase A (alpha-Gal A)
for the treatment of Fabry disease in adults who have
amenable GLA variants. In these patients, Galafold works
by stabilizing the body’s own dysfunctional enzyme so that it can
clear the accumulation of disease substrate. Globally, Amicus
Therapeutics estimates that approximately 35 to 50 percent of Fabry
patients may have amenable GLA variants, though
amenability rates within this range vary by geography. Galafold is
approved in over 40 countries around the world, including the U.S.,
EU, U.K., Japan and others.
U.S. INDICATIONS AND USAGE Galafold is
indicated for the treatment of adults with a confirmed diagnosis of
Fabry disease and an amenable galactosidase alpha gene (GLA)
variant based on in vitro assay data.
This indication is approved under accelerated approval based on
reduction in kidney interstitial capillary cell
globotriaosylceramide (KIC GL-3) substrate. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials.
U.S. IMPORTANT SAFETY INFORMATION
ADVERSE REACTIONS The most common adverse
reactions reported with Galafold (≥10%) were headache,
nasopharyngitis, urinary tract infection, nausea and pyrexia.
USE IN SPECIFIC POPULATIONS There is
insufficient clinical data on Galafold use in pregnant women to
inform a drug-associated risk for major birth defects and
miscarriage. Advise women of the potential risk to a fetus.
It is not known if Galafold is present in human milk. Therefore,
the developmental and health benefits of breastfeeding should be
considered along with the mother’s clinical need for Galafold and
any potential adverse effects on the breastfed child from Galafold
or from the underlying maternal condition.
Galafold is not recommended for use in patients with severe
renal impairment or end-stage renal disease requiring dialysis.
The safety and effectiveness of Galafold have not been
established in pediatric patients.
To report Suspected Adverse Reactions, contact Amicus
Therapeutics at 1-877-4AMICUS or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
For additional information about Galafold, including the full
U.S. Prescribing Information, please
visit https://www.amicusrx.com/pi/Galafold.pdf.
EU Important Safety
InformationTreatment with Galafold should be initiated and
supervised by specialists experienced in the diagnosis and
treatment of Fabry disease. Galafold is not recommended for use in
patients with a nonamenable mutation.
- Galafold is not intended for concomitant use with enzyme
replacement therapy.
- Galafold is not recommended for use in patients with Fabry
disease who have severe renal impairment (<30 mL/min/1.73 m2).
The safety and efficacy of Galafold in children 0–15 years of age
have not yet been established.
- No dosage adjustments are required in patients with hepatic
impairment or in the elderly population.
- There is very limited experience with the use of this medicine
in pregnant women. If you are pregnant, think you may be pregnant,
or are planning to have a baby, do not take this medicine until you
have checked with your doctor, pharmacist, or nurse.
- While taking Galafold, effective birth control should be used.
It is not known whether Galafold is excreted in human milk.
- Contraindications to Galafold include hypersensitivity to the
active substance or to any of the excipients listed in the
PRESCRIBING INFORMATION.
- It is advised to periodically monitor renal function,
echocardiographic parameters and biochemical markers (every 6
months) in patients initiated on Galafold or switched to
Galafold.
- OVERDOSE: General medical care is recommended in the case of
Galafold overdose.
- 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 SUMMARY OF PRODUCT CHARACTERISTICS.
- Call your doctor for medical advice about side effects.
For further important safety information for Galafold, including
posology and method of administration, special warnings, drug
interactions and adverse drug reactions, please see the European
SmPC for Galafold available from the EMA website at
www.ema.europa.eu.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq: FOLD) is a global, patient-dedicated
biotechnology company focused on discovering, developing and
delivering novel high-quality medicines for people living with rare
metabolic diseases. With extraordinary patient focus, Amicus
Therapeutics is committed to advancing and expanding a robust
pipeline of cutting-edge, first- or best-in-class medicines for
rare metabolic diseases. For more information please visit the
company’s website at www.amicusrx.com, and follow on Twitter and
LinkedIn.
Non-GAAP Financial Measures In
addition to financial information prepared in accordance with U.S.
GAAP, this press release also contains adjusted financial measures
that we believe provide investors and management with supplemental
information relating to operating performance and trends that
facilitate comparisons between periods and with respect to
projected information. These adjusted financial measures are
non-GAAP measures and should be considered in addition to, but not
as a substitute for, the information prepared in accordance with
U.S. GAAP. We typically exclude certain GAAP items that management
does not believe affect our basic operations and that do not meet
the GAAP definition of unusual or non-recurring items. Other
companies may define these measures in different ways. Full
reconciliations of GAAP results to the comparable non-GAAP measures
for the reported periods appear in the financial tables section of
this press release. When we provide our expectation for non-GAAP
operating expenses on a forward-looking basis, a reconciliation of
the differences between the non-GAAP expectation and the
corresponding GAAP measure generally is not available without
unreasonable effort due to potentially high variability, complexity
and low visibility as to the items that would be excluded from the
GAAP measure in the relevant future period, such as unusual gains
or losses. The variability of the excluded items may have a
significant, and potentially unpredictable, impact on our future
GAAP results.
Forward-Looking StatementsThis
press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995
relating to preclinical and clinical development of our product
candidates, the timing and reporting of results from preclinical
studies and clinical trials, the prospects and timing of the
potential regulatory approval of our product candidates,
commercialization plans, manufacturing and supply plans, financing
plans, and the projected revenues and cash position for the
Company. The inclusion of forward-looking statements should not be
regarded as a representation by us that any of our plans will be
achieved. Any or all of the forward-looking statements in this
press release may turn out to be wrong and can be affected by
inaccurate assumptions we might make or by known or unknown risks
and uncertainties. For example, with respect to statements
regarding the goals, progress, timing, and outcomes of discussions
with regulatory authorities, and in particular the potential goals,
progress, timing, and results of preclinical studies and clinical
trials, including as they are impacted by COVID-19 related
disruption, are based on current information. The potential
impact on operations from the COVID-19 pandemic is inherently
unknown and cannot be predicted with confidence and may cause
actual results and performance to differ materially from the
statements in this release, including without limitation, because
of the impact on general political and economic conditions,
including as a result of efforts by governmental authorities to
mitigate COVID-19, such as travel bans, shelter in place orders and
third-party business closures and resource allocations,
manufacturing and supply chain disruptions and limitations on
patient access to commercial or clinical product. In addition to
the impact of the COVID-19 pandemic, actual results may differ
materially from those set forth in this release due to the risks
and uncertainties inherent in our business, including, without
limitation: the potential that results of clinical or preclinical
studies indicate that the product candidates are unsafe or
ineffective; the potential that it may be difficult to enroll
patients in our clinical trials; the potential that regulatory
authorities, including the FDA, EMA, and PMDA, may not grant or may
delay approval for our product candidates; the potential that we
may not be successful in commercializing Galafold in Europe, Japan,
the US and other geographies or our other product candidates if and
when approved; the potential that preclinical and clinical studies
could be delayed because we identify serious side effects or other
safety issues; the potential that we may not be able to manufacture
or supply sufficient clinical or commercial products; and the
potential that we will need additional funding to complete all of
our studies and manufacturing. Further, the results of earlier
preclinical studies and/or clinical trials may not be predictive of
future results. Statements regarding corporate financial guidance
and financial goals and the attainment of such goals. With respect
to statements regarding projections of the Company's revenue and
cash position, actual results may differ based on market factors
and the Company's ability to execute its operational and budget
plans. In addition, all forward-looking statements are subject to
other risks detailed in our Annual Report on Form 10-K for the year
ended December 31, 2019, the Quarterly Report filed on Form 10-Q
for the quarter ended March 31, 2020, and the Quarterly Report
filed on Form 10-Q to be filed today. You are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement, and
we undertake no obligation to revise or update this news release to
reflect events or circumstances after the date hereof.
CONTACTS:
Investors:Amicus TherapeuticsAndrew
FaughnanDirector, Investor Relationsafaughnan@amicusrx.com (609)
662-3809
Media:Amicus TherapeuticsDiana MooreHead of
Global Corporate Communicationsdmoore@amicusrx.com(609)
662-5079
FOLD–G
TABLE 1
Amicus
Therapeutics, Inc.Consolidated Statements of
Operations(Unaudited)(in
thousands, except share and per share amounts)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Net product sales |
$ |
62,353 |
|
|
|
$ |
44,130 |
|
|
|
$ |
122,878 |
|
|
|
$ |
78,176 |
|
|
Cost of goods sold |
6,676 |
|
|
|
5,367 |
|
|
|
13,228 |
|
|
|
9,422 |
|
|
Gross profit |
55,677 |
|
|
|
38,763 |
|
|
|
109,650 |
|
|
|
68,754 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
69,611 |
|
|
|
70,981 |
|
|
|
158,731 |
|
|
|
135,574 |
|
|
Selling, general, and
administrative |
34,657 |
|
|
|
42,578 |
|
|
|
74,872 |
|
|
|
86,881 |
|
|
Changes in fair value of
contingent consideration payable |
715 |
|
|
|
480 |
|
|
|
1,646 |
|
|
|
1,863 |
|
|
Depreciation and
amortization |
2,039 |
|
|
|
1,154 |
|
|
|
3,803 |
|
|
|
2,145 |
|
|
Total operating expenses |
107,022 |
|
|
|
115,193 |
|
|
|
239,052 |
|
|
|
226,463 |
|
|
Loss from operations |
(51,345 |
) |
|
|
(76,430 |
) |
|
|
(129,402 |
) |
|
|
(157,709 |
) |
|
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
865 |
|
|
|
2,599 |
|
|
|
2,380 |
|
|
|
5,238 |
|
|
Interest expense |
(3,635 |
) |
|
|
(4,625 |
) |
|
|
(7,364 |
) |
|
|
(11,079 |
) |
|
Loss on exchange of
convertible notes |
— |
|
|
|
(4,501 |
) |
|
|
— |
|
|
|
(40,624 |
) |
|
Other income (expense) |
5,326 |
|
|
|
(877 |
) |
|
|
(2,990 |
) |
|
|
209 |
|
|
Loss before income tax |
(48,789 |
) |
|
|
(83,834 |
) |
|
|
(137,376 |
) |
|
|
(203,965 |
) |
|
Income tax expense |
(3,703 |
) |
|
|
(717 |
) |
|
|
(4,064 |
) |
|
|
(885 |
) |
|
Net loss attributable
to common stockholders |
$ |
(52,492 |
) |
|
|
$ |
(84,551 |
) |
|
|
$ |
(141,440 |
) |
|
|
$ |
(204,850 |
) |
|
Net loss attributable to
common stockholders per common share — basic and diluted |
$ |
(0.20 |
) |
|
|
$ |
(0.36 |
) |
|
|
$ |
(0.55 |
) |
|
|
$ |
(0.91 |
) |
|
Weighted-average common shares
outstanding — basic and diluted |
|
257,973,329 |
|
|
|
|
238,089,824 |
|
|
|
|
257,548,623 |
|
|
|
|
225,848,013 |
|
|
TABLE 2
Amicus
Therapeutics, Inc.Consolidated Balance
Sheets(Unaudited)(in thousands,
except share and per share amounts)
|
June 30, 2020 |
|
December 31, 2019 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
164,573 |
|
|
|
$ |
142,837 |
|
|
Investments in marketable securities |
145,017 |
|
|
|
309,903 |
|
|
Accounts receivable |
43,040 |
|
|
|
33,284 |
|
|
Inventories |
12,979 |
|
|
|
14,041 |
|
|
Prepaid expenses and other current assets |
18,275 |
|
|
|
20,008 |
|
|
Total current assets |
383,884 |
|
|
|
520,073 |
|
|
Operating lease right-of-use assets, less accumulated amortization
of $6,219 and $5,342 at June 30, 2020 and December 31, 2019,
respectively |
23,949 |
|
|
|
33,315 |
|
|
Property and equipment, less accumulated depreciation of $21,194
and $17,604 at June 30, 2020 and December 31, 2019,
respectively |
46,945 |
|
|
|
47,705 |
|
|
In-process research & development |
23,000 |
|
|
|
23,000 |
|
|
Goodwill |
197,797 |
|
|
|
197,797 |
|
|
Other non-current assets |
25,876 |
|
|
|
28,317 |
|
|
Total
Assets |
$ |
701,451 |
|
|
|
$ |
850,207 |
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
14,306 |
|
|
|
$ |
21,722 |
|
|
Accrued expenses and other current liabilities |
85,478 |
|
|
|
99,901 |
|
|
Operating lease liabilities |
8,516 |
|
|
|
7,189 |
|
|
Total current liabilities |
108,300 |
|
|
|
128,812 |
|
|
Deferred reimbursements |
8,906 |
|
|
|
8,906 |
|
|
Convertible notes |
2,203 |
|
|
|
2,131 |
|
|
Senior secured term loan |
147,834 |
|
|
|
147,374 |
|
|
Contingent consideration payable |
20,027 |
|
|
|
22,681 |
|
|
Deferred income taxes |
5,051 |
|
|
|
5,051 |
|
|
Operating lease liabilities |
43,666 |
|
|
|
53,531 |
|
|
Other non-current liabilities |
4,511 |
|
|
|
5,296 |
|
|
Total liabilities |
340,498 |
|
|
|
373,782 |
|
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Common stock, $0.01 par value,
500,000,000 shares authorized, 258,223,842 and 255,417,869 shares
issued and outstanding at June 30, 2020 and December 31, 2019,
respectively |
2,614 |
|
|
|
2,598 |
|
|
Additional paid-in
capital |
2,250,849 |
|
|
|
2,227,225 |
|
|
Accumulated other
comprehensive loss: |
|
|
|
Foreign currency translation adjustment |
4,865 |
|
|
|
2,785 |
|
|
Unrealized gain on available-for-sale securities |
288 |
|
|
|
40 |
|
|
Warrants |
12,387 |
|
|
|
12,387 |
|
|
Accumulated deficit |
(1,910,050 |
) |
|
|
(1,768,610 |
) |
|
Total stockholders’
equity |
360,953 |
|
|
|
476,425 |
|
|
Total Liabilities and
Stockholders’ Equity |
$ |
701,451 |
|
|
|
$ |
850,207 |
|
|
TABLE 3
Amicus
Therapeutics, Inc.Reconciliation of Non-GAAP
Financial Measures(in thousands)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
Total operating expenses
- as reported GAAP |
|
$ |
107,022 |
|
$ |
115,193 |
|
|
$ |
239,052 |
|
$ |
226,463 |
|
Research and development: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
3,362 |
|
|
3,952 |
|
|
|
8,615 |
|
|
8,984 |
|
Selling, general and administrative: |
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
5,046 |
|
|
5,983 |
|
|
|
12,389 |
|
|
13,695 |
|
Changes in fair value of contingent consideration
payable |
|
|
715 |
|
|
480 |
|
|
|
1,646 |
|
|
1,863 |
|
Depreciation and amortization |
|
|
2,039 |
|
|
1,154 |
|
|
|
3,803 |
|
|
2,145 |
|
Total operating expense adjustments to reported
GAAP |
|
|
11,162 |
|
|
11,569 |
|
|
|
26,453 |
|
|
26,687 |
|
Total operating expenses
- as adjusted |
|
$ |
95,860 |
|
$ |
103,624 |
|
|
$ |
212,599 |
|
$ |
199,776 |
|
Amicus Therapeutics (NASDAQ:FOLD)
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Amicus Therapeutics (NASDAQ:FOLD)
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From Apr 2023 to Apr 2024