Full Press Release Details
Esperion Provides Bempedoic Acid Franchise
Development Program Updates;
Reports Third Quarter Financial Results
ANN ARBOR, Mich., November 6, 2019 (GLOBE NEWSWIRE) -- Esperion
(NASDAQ:ESPR) today provided bempedoic acid franchise development program updates and financial results for the third quarter ended
"The Esperion Lipid Management Team continues to lay a
strong and durable foundation for what we believe are highly anticipated approvals and launches of 2020 - bempedoic acid
and the bempedoic acid / ezetimibe combination tablet. We're especially proud to have completed enrollment in the landmark
CLEAR cardiovascular outcomes trial with over 14,000 statin intolerant patients," said Tim M. Mayleben, president and chief
executive officer of Esperion. "Our excitement and confidence continue to grow as we near the potential approval and commercial
launch of our cost-effective, convenient, once-daily, oral LDL-C lowering therapies for the millions of patients on maximally tolerated
statins who need additional LDL-C lowering."
Recent Development Program Highlights
Second quarter 2020:
2019 Financial Outlook
Esperion updated the full-year 2019 outlook for a net increase
in cash of approximately $70 to $80 million (previously $90 to $100 million). The change primarily results from one-time factors
including 1) incremental costs associated with exceeding our patient enrollment target for the landmark CLEAR Outcomes Cardiovascular
Outcomes Trial (CVOT) during the quarter (14,032 patients considered statin intolerant compared with the original target of 12,604
patients), and 2) incremental costs associated with accelerating certain commercial product manufacturing activities into 2019
that were previously planned for the calendar year 2020. The net increase in cash is driven by the following components:
| Collaboration and license agreement cash source | $150 million |
| Oberland Capital revenue-based funding cash source | $125 million |
| R&D cash used | $135 million to $140 million |
| SG&A cash used | $60 million to $65 million |
Esperion expects that current cash resources, coupled with expected
milestone payments under the European commercial collaboration agreement and Oberland Capital revenue-based funding agreement,
and bempedoic acid and the bempedoic acid / ezetimibe combination tablet commercial sales, will be sufficient to fund operations
through profitability.
2019 Third Quarter Financial Results
As of September 30, 2019, cash, cash equivalents, restricted
cash and investment securities available-for-sale totaled $244.8 million compared with $136.3 million at December 31, 2018.
Revenue was $1.0 million for the third quarter of 2019 and $147.4
million for the nine months ended September 30, 2019, compared to $0.0 million for the comparable periods in 2018. Revenue was
primarily attributable to the initial recognition of the upfront payment from the Daiichi Sankyo Europe (DSE) collaboration agreement.
Research and development expenses were $48.3 million for the
third quarter of 2019 and $137.4 million for the nine months ended September 30, 2019, compared to $41.6 million and $122.0 million
for the comparable periods in 2018. The increase was primarily attributable to clinical development costs for bempedoic acid, including
costs to support the ongoing CLEAR
Outcomes Trial, commercial product manufacturing supply as we approach anticipated approval,
and increases in our headcount and stock-based compensation expense.
General and administrative expenses were $18.5 million for the
third quarter of 2019 and $44.1 million for the nine months ended September 30, 2019, compared to $9.0 million and $21.9 million
for the comparable periods in 2018. The increase was primarily attributable to costs to support public company operations, including
costs to support pre-commercialization activities, further increases in our headcount and stock-based compensation expense, and
other costs to support our growth.
Esperion had a net loss of $68.4 million for the third quarter
of 2019 and a net loss of $35.2 million for the nine months ended September 30, 2019, compared to a net loss of $49.9 million and
a net loss of $141.8 million for the comparable periods in 2018.
Esperion had approximately 27.2 million shares of common stock
outstanding, with another 5.3 million issuable upon exercise of stock options and vesting of restricted stock units, and $128.4
million of the revenue interest liability outstanding as of September 30, 2019.
Bempedoic acid is our lead, non-statin, oral, once-daily, low-density
lipoprotein cholesterol (LDL-C) lowering therapeutic candidate, currently under regulatory review by the U.S. Food and Drug Administration
(FDA) and European Medicines Agency (EMA). With a targeted mechanism of action, bempedoic acid is a first-in-class, ATP Citrate
Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptor. Bempedoic acid
has been observed to reduce hsCRP, a key marker of inflammation associated with cardiovascular disease. Completed Phase 3 studies
conducted in more than 4,000 patients, with over 2,600 patients treated with bempedoic acid, demonstrated up to 18 percent placebo
corrected LDL-C lowering when used with moderate- and high-intensity statins and 21 to 28 percent placebo corrected LDL-C lowering
when used with low dose or no background statin.
Bempedoic Acid / Ezetimibe Fixed
Dose Combination Tablet
Through the complementary mechanisms of action of inhibition
of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), the bempedoic acid / ezetimibe
fixed dose combination tablet is a non-statin, orally available, once-daily, LDL-C lowering therapeutic candidate, currently under
review by the FDA and EMA. Inhibition of ATP Citrate Lyase (ACL) by bempedoic acid lowers LDL-C by reducing cholesterol biosynthesis
and up-regulating the LDL receptor. Inhibition of Niemann-Pick C1-Like 1 (NPC1L1) by ezetimibe results in reduced absorption of
cholesterol from the gastrointestinal tract, thereby reducing delivery of cholesterol to the liver. Phase 3 data demonstrated that
this combination resulted in a 29 percent placebo corrected LDL-C lowering when used with maximally tolerated statins, a 44 percent
LDL-C lowering when used with no background statin (post-hoc analysis), and a 34 percent reduction in high sensitivity C-reactive
CLEAR Cardiovascular Outcomes
The effect of bempedoic acid on cardiovascular
morbidity and mortality has not yet 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 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 14,032 patients with hypercholesterolemia and high CVD risk
at over 1,400 sites in 32 countries.
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 or 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. with atherosclerotic cardiovascular disease (ASCVD) who live 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 ASCVD patients who are not able to reach
their LDL-C goals with statins alone need less than a 40 percent reduction to reach their LDL-C threshold2.
Esperion's mission as the Lipid Management Company is to deliver
once-daily, oral therapies that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.
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 therapies
that will make a substantial impact on reducing global cardiovascular disease, the leading cause of death around the world. For
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the regulatory approval
pathway for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, the therapeutic potential of,
and the clinical development plan for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including
Esperion's timing, designs, plans for announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies
for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, timing for the review and approval