Esperion (NASDAQ:ESPR) today reported financial results for the
first quarter ended March 31, 2020, which included the first-ever
product sales revenue for NEXLETOL™ tablets, and provided other
company updates.
“With two marketing approvals in the U.S. and
two in the E.U., the commercial launch of NEXLETOL™ tablets in the
U.S. by our highly-tenured customer-facing team, completion of a
second precedent-setting ex-U.S. collaboration, and achievement of
our ambitious managed care coverage goals in the U.S., our Esperion
team continues to excel,” said Tim M. Mayleben, president and chief
executive officer of Esperion. “These accomplishments
showcase the potential of our Lipid Management business over the
long term as we continue to deliver upon commitments to patients,
healthcare providers, our managed care partners, shareholders, and
other stakeholders.”
Recent Highlights
Clinical and Regulatory:
- January 2020: Positive opinions from the Committee for
Medicinal Products (CHMP) for Human Use of the European Medicines
Agency (EMA) for the Marketing Authorisation Applications (MAAs)
for both NILEMDO™ (bempedoic acid) and NUSTENDI™ (bempedoic acid
and ezetimibe) tablets, recommending approval for the treatment of
hypercholesterolemia and mixed dyslipidemia.
- February 2020: Food and Drug Administration Approvals of
NEXLETOL™ (bempedoic acid) tablets, the first oral, once-daily,
non-statin, LDL-C lowering medicine approved in nearly 20 years for
indicated patients, and NEXLIZET™ (bempedoic acid and ezetimibe)
tablets, the first non-statin, LDL-C lowering combination medicine
ever approved.
- March 2020: Three data presentations from the LDL-cholesterol
lowering development program of NEXLETOL and NEXLIZET presented at
the American College of Cardiology 69th Scientific Session Together
with World Congress of Cardiology.
- April 2020: European Commission Marketing Approvals of NILEMDO
and NUSTENDI.
Commercial:
- March 30, 2020: U.S. commercial availability of NEXLETOL
tablets.
- March 2020: Hired and trained our 300-member U.S.
customer-facing team, averaging over 12 years of cardiovascular
sales experience and supporting outreach to approximately 36,000
healthcare providers.
- April 2020: Achieved NEXLETOL and NEXLIZET managed care
coverage goals, with over 50% commercial coverage and over 20%
Medicare Part D coverage.
Corporate and Business Development:
- March 2020: $25 million payment received from Oberland Capital
upon FDA marketing approval of NEXLETOL tablets.
- April 2020: Entered into a development and commercial
collaboration agreement with Otsuka Pharmaceuticals Co., Ltd. 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.
Upcoming Milestones
June 2020:
- U.S. commercial availability of NEXLIZET tablets on June
4th.
Third Quarter of 2020:
- European commercial launch of NILEMDO and NUSTENDI tablets by
Daiichi Sankyo Europe (DSE).
- $150 million milestone payment from DSE upon first commercial
sale in the EU.
Fourth Quarter 2020:
- Potential Rest-of-World development
and commercial collaboration agreement.
2020 First Quarter Financial
Results
As of March 31, 2020, cash, cash equivalents,
restricted cash and investment securities available-for-sale
totaled $158.2 million compared with $201.7 million at December 31,
2019. This amount does not include the $60.0 million upfront
payment resulting from the Otsuka collaboration agreement that was
received in April 2020.
Total revenue was $1.8 million for the first
quarter of 2020, including approximately $0.8 million of net
product sales of NEXLETOL and $1.0 million in collaboration
revenue. This compares to total revenue of $145.4 million in
the first quarter of 2019, which was attributable to the initial
recognition of the upfront payment from the DSE collaboration
agreement.
Research and development expenses were $34.7
million for the first quarter of 2020, compared to $46.3 million
for the comparable period 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 costs associated with our regulatory
submission activities in 2019.
Selling, general and administrative expenses
were $41.6 million for the first quarter of 2020, compared to $12.2
million for the comparable period in 2019. The increase was
primarily attributable to costs to support the commercialization of
NEXLETOL and NEXLIZET, increases in our headcount resulting from
the buildout of our 300-member customer-facing team, stock-based
compensation expense, and other costs to support our growth.
Esperion had a net loss of $78.2 million for the
first quarter of 2020, compared to net income of $87.4 million for
the comparable periods in 2019. Esperion had a net loss per share
of $2.84 for the first quarter of 2020, compared to diluted net
income per share of $3.07 for the comparable period in 2019.
Esperion had approximately 27.5 million shares
of common stock outstanding, with another 5.2 million issuable upon
exercise of stock options and vesting of restricted stock units,
and $161.7 million of the revenue interest liability outstanding as
of March 31, 2020.
2020 Financial Outlook
Esperion’s pro-forma cash balance as of March
31, 2020 was $218.2 million as a result of the $60 million upfront
payment received in April from Otsuka Pharmaceuticals Co., Ltd. and
expects an additional $150 million in cash proceeds from the
Daiichi Sankyo Europe upon first commercial sale in the EU. This
amount does not include cash generated from U.S. product sales, for
which Esperion is not providing guidance for in 2020, EU royalties,
or upfront and/or milestone payment(s) from a potential
Rest-of-World (ROW) agreement.
Esperion updated the full-year 2020 expense
guidance. Research and development expenses for the full year
2020 are now expected to be $135 million to $145 million
(previously $145 million to $155 million). Selling, general and
administrative expenses for the full year 2020 are now expected to
be $200 million to $210 million (previously $225 million to $235
million). These changes result from a natural slowing of incurred
expenses due to 1.) changes in planned operating expenses due to
the COVID-19 environment during the first and second quarter and
2.) the adjustments to virtual launch programs, tools and marketing
tactics versus office promotional activities. Esperion continues to
expect $30 million in non-cash stock-based compensation.
Esperion expects that current cash resources,
coupled with the expected future milestone payment under the
Daiichi Sankyo Europe collaboration agreement of $150 million and
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 our
sustainable cash runway.
Conference Call and Webcast
Information
Esperion's Lipid Management Team will host a
conference call and webcast on May, 6 at 4:30 P.M. Eastern Time to
provide a Virtual Business 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 7588833. 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 and
other ongoing clinical studies for bempedoic acid tablet and the
bempedoic acid / ezetimibe combination fixed dose tablet, 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. |
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Balance Sheet Data(In
thousands)(Unaudited) |
|
|
|
|
|
March 31,2020 |
|
December 31,2019 |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
149,386 |
|
|
$ |
166,130 |
|
|
Working capital |
|
99,176 |
|
|
|
145,634 |
|
|
Investments |
|
7,931 |
|
|
|
34,651 |
|
|
Restricted cash |
|
928 |
|
|
|
928 |
|
|
Total assets |
|
179,642 |
|
|
|
214,447 |
|
|
Revenue interest liability |
|
161,715 |
|
|
|
132,544 |
|
|
Common stock |
|
28 |
|
|
|
27 |
|
|
Accumulated deficit |
|
(773,515 |
) |
|
|
(695,266 |
) |
|
Total stockholders' equity (deficit) |
|
(50,246 |
) |
|
|
19,950 |
|
|
|
|
|
|
|
|
|
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|
|
|
|
|
|
Esperion Therapeutics, Inc. |
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Statement of Operations |
(In thousands, except share and per share
data)(Unaudited) |
|
|
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|
|
|
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Three Months EndedMarch 31, |
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2020 |
|
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2019 |
|
Revenues: |
|
|
|
|
Product sales, net |
$ |
858 |
|
|
$ |
— |
|
Collaboration revenue |
|
982 |
|
|
|
145,419 |
|
Total Revenues |
|
1,840 |
|
|
|
145,419 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
Cost of goods sold |
|
31 |
|
|
|
— |
|
Research and development |
|
34,702 |
|
|
|
46,308 |
|
Selling, general and administrative |
|
41,553 |
|
|
|
12,182 |
|
Total operating expenses |
|
76,286 |
|
|
|
58,490 |
|
|
|
|
|
|
Income (loss) from operations |
|
(74,446 |
) |
|
|
86,929 |
|
|
|
|
|
|
Interest expense |
|
(4,171 |
) |
|
|
— |
|
Other income, net |
|
368 |
|
|
|
450 |
|
Net income (loss) |
$ |
(78,249 |
) |
|
$ |
87,379 |
|
|
|
|
|
|
Net income (loss) per common share - basic |
$ |
(2.84 |
) |
|
$ |
3.26 |
|
Net income (loss) per common share - diluted |
$ |
(2.84 |
) |
|
$ |
3.07 |
|
|
|
|
|
|
Weighted average shares outstanding - basic |
|
27,519,229 |
|
|
|
26,842,785 |
|
Weighted average shares outstanding - diluted |
|
27,519,229 |
|
|
|
28,449,767 |
|
Investor Contact: Alex Schwartz Esperion
734-249-3386 aschwartz@esperion.com
Media Contact: Ben Church
Esperion734-864-6774bchurch@esperion.com
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