UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of
Incorporation)
| | ||||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
(Address of Principal Executive Offices, and Zip Code)
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark
whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405)
or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 8.01. Other Events
On October 10, 2019, Amicus Therapeutics, Inc. (the "Company") issued a press release announcing preliminary unaudited revenue for the third quarter of 2019 in advance of its Analyst Day, to be held October 10, 2019 in New York City. A copy of this press release is attached hereto as Exhibit 99.1. In addition, the Company will be using the presentation attached as Exhibit 99.2 over the course of its Analyst Day. Both exhibits are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
Exhibits:
| Exhibit No. | Description | |
| 99.1 | October 10, 2019 Press Release | |
| 99.2 | Presentation Materials | |
| 104 | The cover page from this Current Report on Form 8-K, formatted in Inline XBRL |
Signature Page
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMICUS THERAPEUTICS, INC. | ||
| Date: October 10, 2019 | By: | /s/ Ellen S. Rosenberg |
| Name: | Ellen S. Rosenberg | |
| Title: | Chief Legal Officer and Corporate Secretary | |
Exhibit 99.1
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 $170M-$180M on Significant Momentum Across All Major Geographies
Cash Runway Extended from 2021 to Well Into 1H 2022
Analyst Day 2019 Webcast to begin at 8:30a.m. ET
CRANBURY, NJ, October 10, 2019 – 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 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 $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
| 1. | 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 |
| 2. | Financial outlook strengthened with current cash now revised to well into 1H 2022 through major portfolio milestones and global growth |
| 3. | 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 |
| 4. | 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 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 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 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:
Amicus Therapeutics
Sara Pellegrino, IRC
Vice President, Investor Relations
spellegrino@amicusrx.com
(609) 662-5044
Media:
Christopher Byrne
Executive Director, Corporate Communications
cbyrne@amicusrx.com
609-662-2798
FOLD–G
Exhibit 99.2
Amicus Therapeutics Analyst Day 2019 October 10, 2019
Amicus Therapeutics 2019 Analyst Day This presentation 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 presentation 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 presentation 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 presentation to reflect events or circumstances after the date hereof. Forward-Looking Statements 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.
Amicus Therapeutics 2019 Analyst Day Amicus Therapeutics 2019 Analyst Day Agenda 8:30 a.m. - 8:35 a.m. WELCOME & INTRODUCTIONS Sara Pellegrino, Vice President, Investor Relations 8:35 a.m. - 8:45 a.m. VISION, MISSION AND STRATEGY John F. Crowley, Chairman and Chief Executive Officer 8:45 a.m. - 9:00 a.m. FINANCIAL AND OPERATIONAL STRATEGY Daphne Quimi, Chief Financial Officer Bradley Campbell, President and Chief Operating Officer 9:00 a.m. - 9:30 a.m. GALAFOLD: ROADMAP TO $1B IN SALES AND PATIENT PERSPECTIVES Bradley Campbell, President and Chief Operating Officer Simon Jordan, SVP, Head of International Mike Keavany, SVP, Head of US Jayne Gershkowitz, Chief Patient Advocate with Alex Dencker and Sabina Kineen Jay Barth, M.D., Chief Medical Officer 9:30 a.m. - 9:50 a.m. AT-GAA - POTENTIAL TO SHIFT THE TREATMENT PARADIGM IN POMPE DISEASE 9:50 a.m. - 10:00 a.m. Q&A SESSION 10:00 a.m. -10:10 a.m. BREAK 10:10 a.m. - 10:50 a.m. NEXT GENERATION GENE THERAPY PLATFORM & RESEARCH PROGRAM 10:50 a.m. - 11:00 a.m. Q&A SESSION 11:00 a.m. - 11:30 a.m. BATTEN DISEASE GENE THERAPY PORTFOLIO AND PATIENT PERSPECTIVES 11:30 a.m. - 11:50 a.m. CLOSING REMARKS 11:50 a.m. - 12:00 p.m. Q&A SESSION John F. Crowley, Chairman and Chief Executive Officer Hung Do, Ph.D., Chief Science Officer Jeff Castelli, Ph.D., Chief Portfolio Officer and Head of Gene Therapy Jim Wilson, M.D., Ph.D., Rose H Weiss Professor and Director, Orphan Disease Center, Perelman School of Medicine at the University of Pennsylvania Jill Weimer, Ph.D., SVP of Discovery Research & Gene Therapy Science Jayne Gershkowitz, Chief Patient Advocate with the Kahn Family Jeff Castelli, Ph.D., Chief Portfolio Officer and Head of Gene Therapy John F. Crowley, Chairman and Chief Executive Officer
Amicus Therapeutics 2019 Analyst Day October 10, 2019 ? New York, NY 2019 Analyst Day ? John F. Crowley Chairman and Chief Executive Officer Vision, Mission & Strategy
Amicus Therapeutics 2019 Analyst Day Robust R&D Engine Nearly 50+ Lysosomal Disorders and More Prevalent Rare Diseases World Class BIOLOGICS Capabilities GLOBAL COMMERCIAL ORGANIZATION Two Clinical- Stage Gene Therapies ~$575M Cash as of 6/30/19 AT-GAA Phase 3 in Pompe Disease EMPLOYEES in 27 Countries Protein Engineering & Glycobiology Gene Therapy PLATFORM A leading fully-integrated, global rare disease biotechnology company Amicus Therapeutics 2019 Analyst Day Amicus Therapeutics 2019 Analyst Day NCH NCH NCH NCH PENN PENN Amicus has assembled one of the largest portfolios of gene therapy programs for rare diseases in the entire industry PENN PENN MPSIIIB Next Generation MPSIIIA MepseviiTM (vestronidase alfa) (Japan Only)* MPS Franchise Next Generation Research Programs and CNS Gene Therapies CLN 1 Batten Disease CLN8 Batten Disease CLN3 Batten Disease CLN6 Batten Disease Batten Franchise - Gene Therapies Pompe Gene Therapy AT-GAA (Novel ERT + Chaperone) Pompe Franchise Fabry Gene Therapy
A broad and patient focused portfolio to drive value creation Gene Therapy Portfolio $1B+ Opportunity Pompe ERT $1 B-2B+ Opportunity Galafold $1B+ Opportunity Transform the Lives of Thousands of Patients 6
Galafold ® (migalastat) Monotherapy Fabry Franchise COMMERCIAL DISCOVERY PHASE 3 PHASE 1/2 PRECLINICAL REGULATORY *Exclusive license from Ultragenyx for Japanese rights to MepseviiTM, investigator-sponsored trial in Japan underway NCH /PENN Other Tay-Sachs Disease NCH Niemann-Pick Type C (N PC) NCH / PENN CDKL5 Deficiency Disorder GTx / ERT PENN Amicus Therapeutics 2019 Analyst Day Our Passion for Making a Difference Unites Us
Amicus is now at a major inflection point and positioned to create significant shareholder value ahead while advancing our mission for patients
Amicus Therapeutics 2019 Analyst Day Amicus Therapeutics 2019 Analyst Day U Galafold Q3 Preliminary Revenue and Upwardly Revised 2019 Guidance U Galafold Patient Number Update U Updated Cash Runway Guidance and Path to Profitability U Pompe Natural History Published Literature Comparison to AT-GAA U Propel Study Enrollment Update U Data and Path Forward For Amicus/Penn Pompe Gene Therapy U Initial Preclinical Fabry Gene Therapy Results U Additional Data from CLN6 Batten study, including Matched Natural History What's New at Amicus Analyst Day 2019
Amicus Therapeutics 2019 Analyst Day Portfolio of Gene Therapy Programs and Technologies Provides Foundation for Future AT-GAA for Pompe Advances Toward Approval as "Crown Jewel" of Amicus Portfolio Amicus Financial Outlook Strengthened with Current Cash Revised Now to 1H2022 Today's Analyst Day highlights our recent success and outlook across our science, clinical, regulatory and commercial efforts Galafold Continues Strong Launch Performance & Cornerstone of Amicus Success Key Takeaways from Amicus Analyst Day 2019
Amicus Therapeutics 2019 Analyst Day Preliminary unaudited 3Q19 Galafold revenue of Galafold: Key Takeaways from Amicus Analyst Day 2019 $48.0M + exceeds expectations " Achieved 1,000+ net global Galafold patients by end of Q3 Galafold Continues Strong Launch Performance & Cornerstone of Amicus Success " FY19 Galafold guidance upwardly revised to $170M-$180M range " On clear path to $500M+ in 2023 revenue and $1B+ peak
Amicus Therapeutics 2019 Analyst Day Company now fully funded through major milestones in Amicus Financial Outlook Strengthened with Current Cash Revised to 1 H2022 Financial Outlook: Key Takeaways from Amicus Analyst Day 2019 portfolio and continued global growth " Cumulative Galafold projected revenues of $1 B+ in 2020-2022 offset significant majority of company spend/investments " Achieved through OpEx savings, CapEx phasing, program prioritization and increased Galafold revenue projections " Under current operating plan, 2019 is peak year for non-GAAP operating expense on path to profitability " No material business development planned or needed in next several years " Only modest additional capital required to extend runway into profitability with multiple non-equity sources available as/when needed
Amicus Therapeutics 2019 Analyst Day PROPEL pivotal study 80%+ enrolled and expected AT-GAA for Pompe Advances Toward Approval as "Crown Jewel" of Amicus Portfolio AT-GAA: Key Takeaways from Amicus Analyst Day 2019 now to over-enroll (~ 120 Patients) by YE 2019 " Pediatric study underway " Manufacturing PPQ runs at WuXi biologics on track to start this month " New phase 2 data and natural history published literature comparison continue to support potential to become Pompe standard of care " Peak revenue potential of $1 B-$2B, with exclusivity well into 2030s
Amicus Therapeutics 2019 Analyst Day CLN6 data shows profound impact as compared Portfolio of Gene Therapy Programs and Technologies Provides Foundation for Future Gene Therapy: Key Takeaways from Amicus Analyst Day 2019 to natural history now matched for age and baseline. Potential to become first ever approved gene therapy for fatal brain disease in children " CLN3 additional patients to be dosed and AAV intrathecal platform increasingly gives confidence in CLN3 program (largest cause of childhood neurodegeneration, 5,000+ children) " Penn Collaboration is R&D engine, with rights to 50+ diseases " 8 preclinical gene therapies in development and one clinical candidate now generated (Pompe)
Financial & Operational Strategy Daphne Quimi, Chief Financial Officer Bradley Campbell, President and Chief Operating Officer 2019 Analyst Day ? October 10, 2019 ? New York, NY
Our strategy continues to be "Go it Alone" because we believe it is the best way to deliver our medicines to patients and maximize long term shareholder value Amicus Therapeutics 2019 Analyst Day 16 Amicus Therapeutics 2019 Analyst Day $170M-$180M $91.2M $36.9M FY16 FY17 FY18 FY19 $5.0M Strong Q3 performance of ~$48M+ (preliminary/unaudited) gives confidence in upwardly revised guidance of $170-$180M. We expect to fall in the midpoint of this revised guidance, inclusive of FX Galafold Success and FY19 Galafold Revenue Guidance
Robust R&D Engine Nearly 50+ Lysosomal Disorders and More Prevalent Rare Diseases World Class BIOLOGICS Capabilities GLOBAL COMMERCIAL ORGANIZATION Two Clinical- Stage Gene Therapies ~$575M Cash as of 6/30/19 AT-GAA Phase 3 in Pompe Disease EMPLOYEES in 27 Countries Protein Engineering & Glycobiology Gene Therapy PLATFORM
Galafold is on track to generate $1 B+ in projected cumulative revenues from 2020-2022 and is on an Galafold: Precision Medicine for Fabry Disease Galafold Growth Trajectory anticipated path to $500M+ in annual sales in 2023 and $1 B+ annual sales at peak Peak FY18 FY19 FY20 FY21 FY22 FY23 Projected Cumulative Revenues (2020-2022) $170M- $91.2M $180M $1B $1B Annual Revenue $500M
anticipated path to $500M+ in annual sales in 2023 and $1 B+ annual sales at peak Peak FY18 FY19 FY20 FY21 FY22 FY23 Projected Cumulative Revenues (2020-2022) $170M- $91.2M $180M $1B $1B Annual Revenue $500M+
Amicus has invested substantially over the past several years to build world class Investments Poised to Deliver Results Building the Foundation: 2016-2018 global commercial capabilities and to develop/advance AT-GAA for Pompe SG&A: Global Commercialization 11 Established 200+ person team 11 Strong access and reimbursement expertise 11 Presence in 27 countries, 5 continents 11 Cover most major global metabolic centers 11 Experienced team to support entire Amicus portfolio R&D: Develop/Advance AT-GAA 11 Conducted multicenter global Phase 1/2 studies 11 Largest pivotal study ever in lysosomal disorders (PROPEL) 11 Advance manufacturing to commercial scale and quality 11 Begin early commercial inventory build Amicus Therapeutics 2019 Analyst Day Capital Expenditures People Programs Operating Expenses Extension of Cash Runway to Well into 1 H2022 Completion of strategic business review and strategy has driven efficiencies and cost savings while advancing all key programs forward
Amicus has invested substantially over the past several years to build world class Investments Poised to Deliver Results Building the Foundation: 2016-2018 global commercial capabilities and to develop/advance AT-GAA for Pompe SG&A: Global Commercialization 11 Established 200+ person team 11 Strong access and reimbursement expertise 11 Presence in 27 countries, 5 continents 11 Cover most major global metabolic centers 11 Experienced team to support entire Amicus portfolio R&D: Develop/Advance AT-GAA 11 Conducted multicenter global Phase 1/2 studies 11 Largest pivotal study ever in lysosomal disorders (PROPEL) 11 Advance manufacturing to commercial scale and quality 11 Begin early commercial inventory build Amicus Therapeutics 2019 Analyst Day Capital Expenditures People Programs Operating Expenses Extension of Cash Runway to Well into 1 H2022 Completion of strategic business review and strategy has driven efficiencies and cost savings while advancing all key programs forward
With these major investments in SG&A and R&D poised to yield results, 2019 is peak Amicus Therapeutics 2019 Analyst Day year for non-GAAP operating expense on path to profitability - FY19 anticipated non-GAAP operating expense of $410M-$420M Non-GAAP Operating Expense Guidance - Strong operating support organization in place to maximize value of future program advancements and products - Expected non-GAAP operating expense to remain relatively flat in 2020-2022 - Minimal further investment in global commercial infrastructure and team needed to launch AT-GAA Non-GAAP operating expense excludes share-based compensation expense, changes in fair value of contingent consideration, and depreciation Amicus Therapeutics 2019 Analyst Day Well into 1H2022 2.5+ Years Cash Runway ~$420M Cash YE2019 Fully funded through major milestones in portfolio and continued global growth Cash Runway Now to Well into 1 H2022 (2.5+ years)
With these major investments in SG&A and R&D poised to yield results, 2019 is peak Amicus Therapeutics 2019 Analyst Day year for non-GAAP operating expense on path to profitability - FY19 anticipated non-GAAP operating expense of $410M-$420M Non-GAAP Operating Expense Guidance - Strong operating support organization in place to maximize value of future program advancements and products - Expected non-GAAP operating expense to remain relatively flat in 2020-2022 - Minimal further investment in global commercial infrastructure and team needed to launch AT-GAA Non-GAAP operating expense excludes share-based compensation expense, changes in fair value of contingent consideration, and depreciation Amicus Therapeutics 2019 Analyst Day Well into 1H2022 2.5+ Years Cash Runway ~$420M Cash YE2019 Fully funded through major milestones in portfolio and continued global growth Cash Runway Now to Well into 1 H2022 (2.5+ years)
Amicus Therapeutics 2019 Analyst Day Company now fully funded through major milestones in Amicus Financial Outlook Strengthened with Current Cash Revised to 1 H2022 Financial Outlook: Key Takeaways from Amicus Analyst Day 2019 portfolio and continued global growth " Cumulative Galafold projected revenue of $1 B+ in 2020-2022 offsets significant majority of company spend/investments " Achieved through OpEx savings, CapEx phasing, program prioritization and increased Galafold revenue projections " Under current operating plan, 2019 is peak year for non-GAAP operating expense on path to profitability " No material business development planned or needed in next several years " Only modest additional capital required in the outer years to extend runway into profitability with multiple non-equity sources available as/when needed "We push ideas as far and as fast as possible" - Amicus Belief Statement Bradley Campbell, President and Chief Operating Officer Simon Jordan, Senior Vice President and Head of International Mike Keavany, Senior Vice President and Head of US ...taking a leadership role in the treatment of Fabry disease Galafold® (migalastat) Global Launch... Galafold: Precision Medicine for Fabry Disease Galafold: Precision Medicine for Fabry Disease Galafold Snapshot (as of September 30, 2019)
