Amicus Therapeutics Announces Preliminary Third Quarter 2019 Revenue and Financial Outlook at 2019 Analyst Day
Analyst Day 2019 to Highlight Financial Outlook and
Robust Portfolio of Novel Therapies for Rare Metabolic Diseases
3Q19 Galafold® (migalastat) Preliminary Unaudited Revenue of ~$48M+
and 1,000+ Patients on Therapy Reflects Continued Strong Global Uptake
Company Raises Lower End of FY19 Global Galafold Revenue Guidance to
Significant Momentum Across All Major Geographies
Cash Runway Extended from 2021 to Well Into 1H 2022
Analyst Day 2019 Webcast to begin at
The live event will be audio webcasted simultaneously and accessible via the Investors section of the
Preliminary Third Quarter 2019 Revenue
Amicus expects to record approximately
Revenue Guidance and Financial Outlook
Following 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
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
- 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
About
Forward Looking Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of our product candidates, the timing and reporting of results from preclinical studies and clinical trials, the prospects and timing of the potential regulatory approval of our product candidates, commercialization plans, manufacturing and supply plans, financing plans, 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
Non-GAAP Financial Measures
In addition to financial information prepared in accordance with U.S. GAAP, this presentation also contains adjusted financial measures that we believe provide investors and management with supplemental information relating to operating performance and trends that facilitate comparisons between periods and with respect to projected information. These adjusted financial measures are non-GAAP measures and should be considered in addition to, but not as a substitute for, the information prepared in accordance with U.S. GAAP. We typically exclude certain GAAP items that management does not believe affect our basic operations and that do not meet the GAAP definition of unusual or non-recurring items. Other companies may define these measures in different ways. When we provide our expectation for non-GAAP operating expenses on a forward-looking basis, a reconciliation of the differences between the non-GAAP expectation and the corresponding GAAP measure generally is not available without unreasonable effort due to potentially high variability, complexity and low visibility as to the items that would be excluded from the GAAP measure in the relevant future period, such as unusual gains or losses. The variability of the excluded items may have a significant, and potentially unpredictable, impact on our future GAAP results.
CONTACTS:
Investors:
Vice President, Investor Relations
spellegrino@amicusrx.com
(609) 662-5044
Media:
Executive Director, Corporate Communications
cbyrne@amicusrx.com
609-662-2798
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Source: Amicus Therapeutics, Inc.