Amicus Therapeutics (Nasdaq: FOLD) today announced preliminary
unaudited revenue for the third quarter of 2019 in advance of its
Analyst Day, to be held today, October 10, 2019, in New York City
at 8:30 a.m. Today’s Analyst Day will highlight the financial
strength and outlook of the Company in addition to recent progress
and updates related to its early- and late-stage rare disease
portfolio, including a late-stage biologic AT-GAA with breakthrough
therapy designation (BTD) for Pompe disease, a clinical-stage
intrathecal AAV gene therapy with positive interim results in CLN6
Batten disease, and a robust gene therapy pipeline.
The live event will be audio webcasted
simultaneously and accessible via the Investors section of the
Amicus Therapeutics corporate website at
http://ir.amicusrx.com/events-and-presentations, and will be
archived for 90 days.
Preliminary Third Quarter 2019
Revenue
Amicus expects to record approximately $48
million (preliminary and unaudited) in Galafold revenue for the
third quarter 2019, a year-over-year increase of over 133% from
total revenue of $20.6 million in the third quarter of 2018, and a
quarter over-quarter increase of over 8.8% from total revenue of
$44.1 million in the second quarter of 2019. The
Company also achieved its goal of 1,000 patients treated with
Galafold during the third quarter. Global compliance and adherence
rates continue to exceed 90%.
Revenue Guidance and Financial
OutlookFollowing the success in the first three quarters
of the year, in addition to the strength in global Galafold launch
metrics across all major geographies, Amicus is now raising the
lower end of the full-year 2019 Galafold revenue guidance from $160
to $180 million to $170 to $180 million. Following a diligent
review of current and outer year operating and capital expense
projections, and robust outlook for Galafold revenue, Amicus now
expects to end 2019 with more than $420 million in cash on hand and
has extended the cash runway projection from 2021 to well into the
first half of 2022.
John F. Crowley, Chairman and Chief Executive
Officer of Amicus Therapeutics, Inc. stated, “We are very pleased
to host our Amicus Analyst Day this morning on the heels of such
significant momentum across our entire portfolio. With a global
commercial medicine, our late-stage Pompe biologic, and one of the
industry’s largest gene therapy pipelines, we are also fully funded
to achieve our major upcoming milestones as we continue to build a
leading global biotechnology company. With the strength of our
third quarter financials and overall financial outlook, we are well
capitalized and optimally positioned to achieve growing revenues
that significantly contribute to our pipeline investments and
advance us toward profitability.”
Amicus Analyst Day 2019 Key
Takeaways
- Galafold continues strong launch
performance and cornerstone of Amicus success with 1,000+ net
global Galafold patients treated and clear path to projected $500M+
in 2023 and $1B+ peak revenue
- Financial outlook strengthened with
current cash now revised to well into 1H 2022 through major
portfolio milestones and global growth
- AT-GAA for Pompe advances toward
approval as “crown jewel” of Amicus portfolio with peak revenue
potential of $1B-$2B, with exclusivity well into 2030s
- Portfolio of gene therapy programs
and technologies provides foundation for future, including two
clinical-stage programs (CLN6 and CLN3), a Pompe gene therapy
clinical candidate declared to move into IND-enabling studies, and
eight additional preclinical gene therapies
Amicus Analyst Day
Agenda:Today’s Amicus Analyst Day agenda is expected to
run from 8:30am ET to Noon ET to highlight the Company’s overall
vision and strategy as well as recent progress and new updates
across the entire portfolio.
- Vision, Mission and Strategy
- Financial and Operational Strategy
- Galafold: Roadmap to $1B in Sales and Patient
Perspectives
- AT-GAA: Potential to Shift the Treatment Paradigm in
Pompe Disease
- Next Generational Gene Therapy Platform & Research
Program
- Batten Disease Gene Therapy Portfolio and Patient
Perspectives
The Amicus team will be joined by several
external guests including James M. Wilson, M.D., Ph.D., Professor
of Medicine and Pediatrics, Perelman School of Medicine; Sabina
Kineen and Alex Dencker, two individuals living with Fabry disease;
and David and Karen Kahn, parents and caregivers to two daughters,
Amelia and Makenzie, living with CLN3 Batten disease.
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.
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, business development plans and the projected revenues,
sales, expenses 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 or projections 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, 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. With respect to statements regarding
projections of the Company's revenue, sales, expenses and cash
position, actual results may differ based on market factors and the
Company's ability to execute its operational and budget plans and
strategies. 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, 2018. 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 press release to reflect events
or circumstances after the date hereof.
Non-GAAP Financial MeasuresIn
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.
CONTACTS:
Investors:Amicus TherapeuticsSara Pellegrino,
IRCVice President, Investor Relationsspellegrino@amicusrx.com(609)
662-5044
Media:Christopher Byrne Executive Director,
Corporate Communications cbyrne@amicusrx.com609-662-2798
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