Item 8.01. Other Events.
Esperion
Therapeutics, Inc. (the “Company”) previously announced that on February 21, 2020, the U.S. Food and Drug Administration
(“FDA”) approved NEXLETOL™ (bempedoic acid) tablet as an adjunct to diet and maximally tolerated statin therapy
for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease
who require additional lowering of LDL-C, and on February 26, 2020, the FDA approved NEXLIZET™ (bempedoic acid and ezetimibe)
tablet as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia
or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. The
effect of NEXLETOL and NEXLIZET on cardiovascular morbidity and mortality has not been determined.
Also,
the Company announced in February 2020 that NEXLETOL will be commercially available for U.S. patients on March 30, 2020,
and NEXLIZET will be commercially available for U.S. patients in July 2020. Both NEXLETOL and NEXLIZET will be available by prescription
only.
On
January 31, 2020, the Company announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the
European Medicines Agency (“EMA”) adopted a positive opinion for the Marketing Authorisation Applications
(“MAAs”) of both the bempedoic acid and bempedoic acid / ezetimibe combination tablets, recommending approval
for the treatment of hypercholesterolemia and mixed dyslipidemia. The two MAAs will be applicable to all 28 European Union
member states plus the United Kingdom, Iceland, Norway and Liechtenstein.
On April 6, 2020, the Company issued press releases announcing
that that the European Commission approved NILEMDO™ (bempedoic acid) tablet and NUSTENDI™ (bempedoic acid and ezetimibe)
tablet for the treatment of hypercholesterolemia and mixed dyslipidemia. Copies of the Press Releases are furnished herewith as
Exhibit 99.1 and Exhibit 99.2.
On March 30, 2020, the Company issued a press release announcing
the commercial launch of NEXLETOL. A copy of the Press Release is furnished herewith as Exhibit 99.3.
The
Company is supplementing the risk factors previously included in Item 1A of its Annual Report on Form 10-K for the
year ended December 31, 2019, filed with the SEC on February 27, 2020, to add the following new risk factor under the section entitled
“Risks Related to our Business and the Clinical Development and Commercialization of our Product Candidates”:
The outbreak of the novel
strain of coronavirus, SARS-CoV-2, or similar public health crises, could have a material adverse impact on our business, financial
condition and results of operations, including our commercial launch of NEXLETOL, our intended commercial launch of NEXLIZET, and
operations and sales in general.
In
December 2019, a novel strain of coronavirus, SARS-CoV-2, which causes coronavirus disease 2019 (COVID-19), surfaced in Wuhan,
China. Since then, SARS-CoV-2 and COVID-19 have spread to multiple countries, including the United States. The COVID-19 pandemic
is evolving, and to date has led to the implementation of various responses, including government-imposed quarantines, travel restrictions
and other public health safety measures. In response to the spread of SARS-CoV-2 and COVID-19, our commercial and medical organizations
have suspended personal interactions with physicians and customers and will be conducting activities virtually.
As a result of the COVID-19 outbreak, or similar pandemics,
we may experience disruptions that could severely impact our business, including our clinical development and commercialization
plans for the bempedoic acid and bempedoic acid / ezetimibe fixed dose combination tablets. As a result of the current pandemic,
or future pandemics, we may not be able to meet expectations with respect to NEXLETOL and NEXLIZET sales or attain or maintain
profitability and positive cash-flow from operations. Our ongoing clinical studies for bempedoic acid tablet and the timing for
the review and approval of expanded indications for their effect on cardiovascular events may be impacted as well. Business interruptions
from the current or future pandemics may also adversely impact the third parties we solely rely on to sufficiently manufacture
NEXLETOL and NEXLIZET and to produce our product candidates in quantities we require, which may impair the commercialization of
NEXLETOL and NEXLIZET and our research and development activities.
Some
factors from the COVID-19 outbreak that may delay or otherwise adversely affect our business generally, and the third parties which
we rely upon, include business disruptions caused by potential workplace, laboratory and office closures and an increased reliance
on employees working from home, disruptions to or delays in ongoing laboratory experiments and operations, staffing shortages,
travel limitations or mass transit disruptions, any of which could adversely impact our business operations or delay necessary
interactions with local regulators, ethics committees and other important agencies and contractors.
The COVID-19 outbreak continues to rapidly evolve. The extent
to which the outbreak impacts our business, including our commercial results and clinical trials will depend on future developments,
which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the
duration of the outbreak, travel restrictions and actions to contain the outbreak or treat its impact, such as social distancing
and quarantines or lock-downs in the United States and other countries, business closures or business disruptions and the effectiveness
of actions taken in the United States and other countries to contain and treat the disease.
Please also refer to the complete Item 1A of the Company’s
Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2020 for additional risks and uncertainties
facing the Company that may have a material adverse effect on the Company’s business prospects, financial condition and results
of operations.
Cautionary Note on Future Updates
The statements contained and incorporated herein reflect the
Company’s current views with respect to future events, which may change significantly as the global consequences of the COVID-19
pandemic rapidly develop. Accordingly, the Company does not undertake and specifically disclaims any obligation to update any forward-looking
statements.