Item 7.01. Regulation FD Disclosure.
On March 4, 2023, Esperion Therapeutics, Inc. (the “Company”) announced the full
results from its Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting
Regimen (CLEAR) Outcomes trial, which were presented at the American College of
Cardiology’s Annual Scientific Session & Expo together with the World Congress
of Cardiology and simultaneously published in the New England Journal of
Medicine. CLEAR Outcomes was a global study of nearly 14,000 patients with or at
risk for cardiovascular disease who were unable to maximize or tolerate a
statin. A copy of the press release is being furnished herewith as Exhibit 99.1.
The information contained in Item 7.01 of this Current Report on Form 8-K and
Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or
otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, except
as expressly set forth by specific reference in such filing.
Item 8.01. Other Information. Business Update
The Company is filing information for the purpose of supplementing and updating
certain aspects of the description of its business from that described under the
heading, “Item 1. Business” in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2022, filed with the U.S. Securities and Exchange
Commission (the “SEC”) on February 21, 2023. The updated disclosure is set forth
below:
On March 4, 2023, the Company announced the full results from its Cholesterol
Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial.
CLEAR Outcomes was a global study of nearly 14,000 patients with or at risk for
cardiovascular disease who were unable to maximize or tolerate a statin. The
study showed that NEXLETOL significantly reduced the risk of hard MACE-4 and
MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart
attack and coronary revascularization by 23% and 19%, respectively, as compared
to placebo. These results were seen in a broad population of primary and
secondary prevention patients who are unable to maximize or tolerate a statin.
The proportions of patients experiencing adverse events and serious adverse
events were similar between the active and placebo treatment groups. Bempedoic
acid (contained in NEXLEOL and NEXLIZET® (bempedoic acid and ezetimibe) tablets)
now becomes the first LDL-C lowering therapy since statins proven to lower hard
ischemic events, not only in those with ASCVD but also in the large number of
primary prevention patients for whom limited therapies exist.
The Company believes that it remains on track to submit regulatory filings to
the FDA and EMA in the first half 2023. Based on the robustness of the CLEAR
Outcomes data, the Company believes it would be entitled to receive $300 million
in partner milestone payments upon inclusion of certain required cardiovascular
risk reduction data in the EU label, for which payment is tied to the magnitude
of the risk percentage reduction included in the label (among other
requirements) and ranges from $200 million to $300 million, and up to $140
million in partner milestone payments upon the achievement of other regulatory
milestones, including inclusion of certain required cardiovascular risk
reduction data in the US label. While the Company believes it would be entitled
to receive such funds upon meeting the foregoing requirements, the Company
cautions that receipt of any milestone payment amounts is subject to risks and
uncertainties, including the Company obtaining the relevant regulatory approvals
and marketing authorizations, the approval of the required EU and US labels, the
absence of any material disagreements or disputes with regulators or our
collaboration partners and the ultimate timing and payment of such milestone
payment amounts by our collaboration partners. In addition, while the Company
expects that it will be entitled to the foregoing milestone payments, its
inability to receive some or all of its milestone payments and other royalty
amounts from its collaboration partners may significantly impact its future
capital needs.
Forward-Looking Statements
This Form 8-K contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including statements
regarding expected operational expenses, expected revenue of our commercial
products, future operations, expected milestone payments from partners,
commercial products and expected growth, clinical development and regulatory
submissions, and other statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,”
“target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and
similar expressions. Any express or implied statements contained in this press
release that are not statements of historical fact may be deemed to be
forward-looking statements. Forward-looking statements involve risks and
uncertainties that could cause the Company’s actual results to differ
significantly from those projected, including, without limitation, the impact of
the ongoing COVID-19 pandemic on our business, revenues, results of operations
and financial condition, the net sales, profitability, and growth of the
Company’s commercial products, clinical activities and results, supply chain,
commercial development and launch plans, and the risks detailed in the Company’s
filings with the Securities and Exchange Commission. Any forward-looking
statements contained in this press release speak only as of the date hereof, and
Esperion disclaims any obligation or undertaking to update or revise any
forward-looking statements contained in this press release, other than to the
extent required by law.
Item 9.01. Financial Statements and Exhibits.
Exhibit No. Description
99.1 Press release dated March 4, 2023.
104 The cover page from this Current Report on Form 8-K, formatted in
Inline XBRL.
© Edgar Online, source Glimpses
postbrexitcompliance.com 