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.”
Recent Highlights
Clinical and Regulatory:
- April 2020: European Commission Marketing Approvals of NILEMDO™
(bempedoic acid) and NUSTENDI™ (bempedoic acid and ezetimibe)
tablets for the treatment of hypercholesterolemia and mixed
dyslipidemia.
- July 2020: Pooled LDL-C lowering efficacy analysis from the
four Phase 3 clinical studies of NEXLETOL was published in the
Journal of the American Medical Association Cardiology.
- July 2020: For the CLEAR Outcomes global cardiovascular
outcomes trial (CVOT), the study has now accumulated almost 50% of
events in this event-driven cardiovascular outcomes study.
Commercial:
- March 30, 2020: U.S. commercial availability of NEXLETOL
tablets.
- June 4, 2020: U.S. commercial availability of NEXLIZET
tablets.
- July 2020: Surpassed NEXLETOL and NEXLIZET one-year managed
care coverage goals, with over 80% commercial coverage and over 50%
Medicare Part D coverage with preferred brand formulary status less
than four months after initial launch.
Corporate and Business Development:
- April 2020: Entered into a development and commercial
collaboration agreement with Otsuka Pharmaceuticals Co., Ltd.
(Otsuka) to develop and commercialize NEXLETOL and NEXLIZET tablets
in Japan. Payments to Esperion under the agreement include $60
million upfront (received in April), up to an additional $450
million in development and sales milestones, approximately $100
million in development costs funded by Otsuka, and 15% to 30%
tiered royalties on net product sales in Japan.
- June 2020: $150 million payment received from Daiichi Sankyo
Europe (DSE) upon completion of the transfer of Marketing
Authorization for NUSTENDI tablets to DSE.
Upcoming Milestones
Fourth Quarter 2020:
- DSE to initiate commercial rollout of NILEMDO and NUSTENDI
tablets in Europe.
- Potential Rest-of-World (ROW) development and commercial
collaboration agreement.
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.
Conference Call and Webcast Information
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 Outcomes Trial
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 leading cause of death around
the world. For more information, please visit www.esperion.com and
follow us on Twitter at www.twitter.com/EsperionInc.
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
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 clinical
development and commercialization plans 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, timing for the review
and approval of expanded indications for their effect on
cardiovascular events, and Esperion's expectations for the market
for medicines to lower LDL-C, including the commercial launch and
market adoption of bempedoic acid tablet and the bempedoic acid /
ezetimibe fixed dose combination tablet in the United States and
European Union. 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 Esperion's actual
results to differ significantly from those projected, including,
without limitation, delays or failures in Esperion’s clinical
development and commercialization plans, or approval of expanded
indications, that existing cash resources may be used more quickly
than anticipated, that Otsuka is able to successfully commercialize
bempedoic acid and the bempedoic acid / ezetimibe fixed dose
combination tablet, the impact of COVID-19 on our business,
clinical activities and commercial development plans, and the risks
detailed in Esperion'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.
References(1) Esperion market research on
file: research project interviewing 350 physicians. Esperion
Therapeutics, Inc. Sept-Oct 2018.(2) Data on file: analysis
of NHANES database. Esperion Therapeutics, Inc. 2018.
Esperion Therapeutics, Inc. |
|
Balance Sheet Data |
(In thousands) |
(Unaudited) |
|
|
|
|
June 30,2020 |
|
December 31,2019 |
|
|
|
|
Cash and cash equivalents |
$ |
298,489 |
|
|
$ |
166,130 |
|
Working
capital |
|
237,490 |
|
|
|
145,634 |
|
Investments |
|
2,247 |
|
|
|
34,651 |
|
Restricted
cash |
|
— |
|
|
|
928 |
|
Total assets |
|
330,352 |
|
|
|
214,447 |
|
Revenue interest
liability |
|
166,291 |
|
|
|
132,544 |
|
Common stock |
|
28 |
|
|
|
27 |
|
Accumulated
deficit |
|
(648,904 |
) |
|
|
(695,266 |
) |
Total
stockholders' equity |
|
85,489 |
|
|
|
19,950 |
|
|
|
|
|
Esperion Therapeutics, Inc. |
|
Statement of Operations |
(In thousands, except share and per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
609 |
|
$ |
— |
|
|
$ |
1,467 |
|
|
$ |
— |
Collaboration revenue |
|
211,627 |
|
|
982 |
|
|
|
212,609 |
|
|
|
146,401 |
Total Revenues |
|
212,236 |
|
|
|
982 |
|
|
|
214,076 |
|
|
|
146,401 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
$ |
398 |
|
|
$ |
— |
|
|
$ |
429 |
|
|
$ |
— |
Research and development |
|
34,987 |
|
|
|
42,788 |
|
|
|
69,689 |
|
|
|
89,096 |
Selling, general and administrative |
|
47,681 |
|
|
|
13,492 |
|
|
|
89,234 |
|
|
|
25,674 |
Total operating expenses |
|
83,066 |
|
|
|
56,280 |
|
|
|
159,352 |
|
|
|
114,770 |
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
129,170 |
|
|
|
(55,298 |
) |
|
|
54,724 |
|
|
|
31,631 |
|
|
|
|
|
|
|
|
Interest expense |
|
(4,640 |
) |
|
|
— |
|
|
|
(8,811 |
) |
|
|
— |
Other income, net |
|
81 |
|
|
|
1,077 |
|
|
|
449 |
|
|
|
1,527 |
Net income (loss) |
$ |
124,611 |
|
|
$ |
(54,221 |
) |
|
$ |
46,362 |
|
|
$ |
33,158 |
|
|
|
|
|
|
|
|
Net income (loss) per common share - basic |
$ |
4.50 |
|
|
$ |
(2.01 |
) |
|
$ |
1.68 |
|
|
$ |
1.23 |
Net income (loss) per common share – diluted |
$ |
4.32 |
|
|
$ |
(2.01 |
) |
|
$ |
1.60 |
|
|
$ |
1.16 |
|
|
|
|
|
|
|
|
Weighted average shares outstanding - basic |
|
27,665,728 |
|
|
|
26,968,818 |
|
|
|
27,592,479 |
|
|
|
26,906,149 |
Weighted average shares outstanding - diluted |
|
28,854,445 |
|
|
|
26,968,818 |
|
|
|
28,948,058 |
|
|
|
28,518,015 |
Contact: Ben Church Esperion734-864-6774bchurch@esperion.com
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