Full Press Release Details
Esperion Reports Second Quarter 2020
Financial Results and Provides Company Update
Quarterly and First Half Total Revenue in Company History with $214 million in Total YTD Revenue -
Capital Position with over $300 Million in Cash -
High-Quality Managed Care Coverage with Over 80% Commercial and Over 50% Medicare Part D Formulary Coverage -
High Month-Over-Month Growth for New Medicines With Acceleration in Second Half -
Call and Webcast on August 10 at 4:30 P.M. Eastern Time -
ANN ARBOR, Mich., August 10, 2020 (GLOBE NEWSWIRE) -- Esperion
(NASDAQ:ESPR) today reported financial results for the second quarter ended June 30, 2020, which included the highest quarterly
and first half revenue in Company history and other updates, including the establishment of a strong commercial foundation to further
accelerate the launch of NEXLETOL (bempedoic acid) tablets and NEXLIZET (bempedoic acid and ezetimibe)
tablets in the second half of 2020.
"Esperion is in a stronger position today than ever before,
fortified by the significant business achievements of our Lipid Management Team. We successfully navigated through the unprecedented
environment created by the COVID-19 pandemic to launch our first two medicines, deliver on our partnerships in Japan and Europe,
and strengthen our balance sheet," said Tim M. Mayleben, president and chief executive officer of Esperion. "The early
feedback from U.S. healthcare providers and payers on NEXLETOL and NEXLIZET has been extraordinary, reflecting
strong positioning as affordable, complementary, convenient, oral, once-daily LDL-C lowering medicines and further confirmed by
the broad, high-quality managed care coverage we've already secured so early in our commercial launch. While stay at home
orders that were in effect across the U.S. for most of the quarter shifted the deployment of our field sales team, July prescription
volumes demonstrate that all the pieces are now in place for healthcare providers and patients to access our medicines in volume."
Clinical and Regulatory:
Corporate and Business Development:
Fourth Quarter 2020:
2020 Second Quarter Financial Results
As of June 30, 2020, cash, cash equivalents, restricted
cash and investment securities available-for-sale totaled $300.7 million compared with $201.7 million at December 31, 2019.
Total revenue was $212.2 million for the second quarter of 2020
and $214.1 million for the six months ended June 30, 2020. This amount includes approximately $0.6 million of net product
sales and $211.6 million in collaboration revenue for the second quarter of 2020 and $1.5 million and $212.6 million, respectively,
for the six months ended June 30, 2020. This compares to total revenue of $1.0 million for the second quarter of 2019 and
$146.4 million for the six months ended June 30, 2019. The increase in revenue was primarily related to the $60.0 million
upfront payment from the collaboration with Otsuka, $150.0 million of collaboration revenue from DSE as well as net product sales
of NEXLETOL and NEXLIZET.
Research and development expenses were $35.0 million for the
second quarter of 2020 and $69.7 million for the six months ended June 30, 2020, compared to $42.8 million and $89.1 million
for the comparable periods in 2019. The decrease was primarily attributable to a decline in costs related to the completion of
enrollment of our CLEAR CVOT, which was fully enrolled during the third quarter of 2019, and a decline in costs related to our
regulatory submission activities completed in 2019.
Selling, general and administrative expenses were $47.7 million
for the second quarter of 2020 and $89.2 million for the six months ended June 30, 2020, compared to $13.5 million and $25.7
million for the comparable periods in 2019. The increase was primarily attributable to costs to support the commercialization of
NEXLETOL and NEXLIZET in the U.S., increases in our headcount resulting from the buildout of our approximately 300-member customer-facing
team, stock-based compensation expense, and other costs to support our growth.
Esperion had net income of $124.6 million for the second quarter
of 2020 and $46.4 million for the six months ended June 30, 2020, compared to net loss of $54.2 million and net income of
$33.2 million for the comparable periods in 2019. Esperion had a basic and diluted net income per share of $4.50 and $4.32, respectively,
for the second quarter of 2020 and $1.68 and $1.60, respectively, for the six months ended June 30, 2020, compared to a basic
and diluted net loss per share of $2.01 and a basic and diluted net income per share of $1.23 and $1.16, respectively, for the
comparable periods in 2019.
Esperion had approximately 27.8 million shares of common stock
outstanding, with another 5.1 million issuable upon exercise of stock options and vesting of restricted stock units, and $166.3
million of the revenue interest liability outstanding as of June 30, 2020.
2020 Financial Outlook
Esperion's cash, cash equivalents, and investments held
available-for-sale as of June 30, 2020 totaled $300.7 million and expects further cash to be provided from U.S. product sales,
for which Esperion is not providing guidance for in 2020, EU royalties, and upfront and/or milestone payment(s) from a potential
ROW agreement for the remainder of 2020.
Research and development expenses for the full year 2020 are
expected to be $135 million to $145 million. Selling, general and administrative expenses for the full year 2020 are expected to
be $200 million to $210 million. These amounts do not include $30 million in non-cash stock-based compensation.
Esperion expects that current cash resources, coupled with revenue
from NEXLETOL and NEXLIZET commercial net product sales are sufficient to fund continued operations through profitability. Any
additional cash proceeds as a result from a ROW collaboration and the additional $50 million available to Esperion, at its option,
under the Oberland Capital revenue-based funding agreement, are incremental to our path to profitably and further secures Esperion's
sustainable cash runway.
Esperion's Lipid Management
Team will host a conference call and webcast on August 10, 2020 at 4:30 P.M. Eastern Time to provide a second quarter
2020 financial results and company update. The call can be accessed by dialing (877) 312-7508 (domestic) or (253) 237-1184 (international)
five minutes prior to the start of the call and providing the access code 7393523. A live audio webcast can be accessed on the
investors and media section of the Esperion website at investor.esperion.com. Access to the webcast replay will be available approximately
two hours after completion of the call and will be archived on the Company's website for approximately 90 days.
CLEAR Cardiovascular
The effect of bempedoic
acid on cardiovascular morbidity and mortality has not been determined. Esperion initiated a global cardiovascular outcomes trial
(CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk
for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and
are considered "statin averse." The CVOT - known as CLEAR Cardiovascular Outcomes Trial - is an event-driven,
global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of over 14,000 patients
with hypercholesterolemia and high CVD risk at over 1,400 sites in 32 countries.
Esperion Therapeutics
Through scientific and
clinical excellence, and a deep understanding of cholesterol biology, the experienced Lipid Management Team at Esperion is committed
to developing new LDL-C lowering medicines that will make a substantial impact on reducing global cardiovascular disease, the
Esperion Therapeutics'
Commitment to Patients with Hyperlipidemia
High levels of LDL-C can
lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular
events, including heart attack and stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have
elevated LDL-C. There are approximately 18 million people in the U.S. living with elevated levels of LDL-C despite taking maximally
tolerated lipid-modifying therapy - including individuals considered statin averse - leaving them at high risk for
cardiovascular events1. In the United States, more than 50 percent of atherosclerotic cardiovascular disease (ASCVD)
patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C
levels with statins alone need less than a 40 percent reduction to reach their LDL-C threshold goal2.
Esperion's mission as
the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional
LDL-C lowering that these patients need.
Forward-Looking Statements