Esperion (NASDAQ: ESPR) today reported financial results for the
second quarter ended June 30, 2022 and provided a business update.
“Throughout the second quarter of 2022, we have continued to
demonstrate consistent growth and we have made significant progress
in advancing our unprecedented CLEAR Outcomes trial, which has now
reached 100% MACE accumulation,” said Sheldon Koenig, president and
chief executive officer of Esperion. “We are thrilled to attain
this significant milestone that brings us even closer to completion
of this landmark cardiovascular outcomes study, particularly during
a remarkable period in the global healthcare environment. Looking
ahead, we are rapidly approaching a transformative moment for the
company and our entire organization is focused on accelerating the
CLEAR Outcomes trial database lock, with topline results readout
from the study on track for the first quarter of 2023. These
results remain of critical importance for millions of patients
globally with or at risk for cardiovascular disease. CLEAR outcomes
will unequivocally answer the question of whether bempedoic acid
lowers cardiovascular morbidity and mortality risk.”
Second Quarter 2022 Key Accomplishments and Recent
Highlights
- Accumulated the targeted 1,620 (100%) primary major adverse
cardiovascular events (MACE-4) in the CLEAR Cardiovascular Outcomes
Trial (CVOT).
- Announced establishment of a Scientific Advisory Board,
co-chaired by renowned physician-scientist Peter Libby, MD, FAHA,
the Mallinckrodt Professor of Medicine at Harvard Medical School,
current president of the International Atherosclerosis Society, and
member of the executive committee for Esperion’s CLEAR Outcomes
study and JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of
Esperion.
- Announced appointment of J. Martin Carroll as new Chairperson
of Esperion’s Board of Directors.
- Partner Otsuka completed its Phase 2 dose-finding trial of
bempedoic acid tablets and plans to advance to Phase 3.
- Announced scientific presentations at the National Lipid
Association Scientific Sessions, including important new data from
partnership with University of Texas Southwestern, highlighting
real-world data on lipid-lowering therapy usage. The real-world
analysis revealed that less than 1 in 10 adults at high risk for
atherosclerotic cardiovascular disease (ASCVD) were on any
non-statin lipid lowering therapy, demonstrating the shortfalls in
the application of professional guidelines and the need for greater
awareness of FDA-approved, non-statin lipid-lowering
therapeutics.
Second Quarter 2022 Financial Results
Total revenue for the second quarter ended June 30, 2022, was
$18.8 million and $37.7 million for the six months ended June 30,
2022, compared to $40.7 million and $48.6 million for the
comparable periods in 2021, a decrease of 54% and 23%,
respectively. The decrease is due to a one-time milestone payment
from our collaboration partners in the second quarter of 2021,
partially offset by increases in net U.S. product revenue, royalty
revenue, and product sales to collaboration partners under our
supply agreements.
U.S. product revenue for the second quarter ended June 30, 2022,
was $13.6 million and $26.9 million for the six months ended June
30, 2022, compared to $10.6 million and $17.0 million for the
comparable periods in 2021, an increase of 28% and 59%,
respectively.
Royalty revenue for the second quarter ended June 30, 2022, was
$1.5 million and $2.6 million for the six months ended June 30,
2022, compared to $1.0 million and $1.6 million for the comparable
periods in 2021, an increase of 50% and 63%, respectively. Royalty
and partner revenue growth is driven by continued adoption in our
partner territories and new country launches.
Research and development expenses for the second quarter ended
June 30, 2022, were $32.4 million and $56.8 million for the six
months ended June 30, 2022, compared to $25.1 million and $53.0
million for the comparable periods in 2021, an increase of 29% and
7%, respectively. The increase is primarily related to an increase
in CVOT costs as we approached 100% MACE accumulation and started
close-out activities.
Selling, general and administrative expenses were $29.6 million
for the second quarter ended June 30, 2022, and $60.0 million for
the six months ended June 30, 2022, compared to $46.3 million and
$107.4 million for the comparable periods in 2021, a decrease of
36% and 44%, respectively. These decreases reflect savings from the
transformative plan implemented in the fourth quarter of 2021.
Esperion had net losses of $66.3 million for the second quarter
of 2022 and $123.1 million for the six months ended June 30, 2022,
compared to net losses of $43.7 million and $134.6 million for the
comparable periods in 2021. Esperion had basic and diluted net
losses per share of $1.05 for the second quarter of 2022 and $1.98
for the six months ended June 30, 2022, compared to basic and
diluted net losses per share of $1.67 and $5.16 for the comparable
periods in 2021.
As of June 30, 2022, cash, cash equivalents, restricted cash and
investment securities available-for-sale totaled $235.8 million
compared with $309.3 million on December 31, 2021.
Esperion ended the quarter with approximately 64.6 million
shares of common stock outstanding, excluding the 2.0 million
treasury shares to be purchased in the prepaid forward transaction
as part of the convertible debt financing.
2022 Financial Outlook
The Company is reaffirming its prior operational expense
guidance. Research and Development expenses for the full year 2022
are expected to be $100 million to $110 million. Selling, General
and Administrative expenses for the full year 2022 are expected to
be $120 million to $130 million.
Esperion expects full-year 2022 operating expenses to be
approximately $220 million to $240 million, inclusive of $25
million of non-cash, stock-based compensation expense.
Conference Call and Webcast InformationEsperion
will host a webcast at 8:00 a.m. ET to discuss financial results
and business progress. Please click here to pre-register to
participate in the conference call and obtain your dial in number
and PIN.
A live audio webcast can be accessed on the investor and media
section of the Esperion website. 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 TrialThe 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. 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 1,200 sites in 32 countries.
Esperion TherapeuticsEsperion works hard to
make our medicines easy to get, easy to take and easy to have. We
discover, develop, and commercialize innovative medicines and
combinations to lower cholesterol, especially for patients whose
needs aren’t being met by the status quo. Our entrepreneurial team
of industry leaders is inclusive, passionate and resourceful. We
are singularly focused on managing cholesterol so you can improve
your health easily. Esperion commercializes NEXLETOL® (bempedoic
acid) and NEXLIZET® (bempedoic acid and ezetimibe) Tablets and is
the leader in the development of convenient oral, once-daily
non-statin LDL-cholesterol lowering drugs for patients with high
levels of bad cholesterol. For more information, please visit
www.esperion.com and follow us on Twitter at
www.twitter.com/EsperionInc.
Forward-Looking StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding marketing strategy and commercialization
plans, current and planned operational expenses, future operations,
commercial products, clinical development, including the timing,
designs and plans for the CLEAR Outcomes study and its results,
plans for potential future product candidates, financial condition
and outlook, including expected cash runway, 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
Esperion’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 Esperion’s commercial products, clinical activities and results,
supply chain, commercial development and launch 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.
Contact:Esperion Corporate
Communicationscorporateteam@esperion.com
ESPERION
Therapeutics, Inc.
Balance Sheet Data(In
thousands)(Unaudited)
|
|
June 30,2022 |
|
December 31,2021 |
Cash and cash equivalents |
|
$ |
122,940 |
|
|
$ |
208,892 |
|
Restricted cash |
|
|
50,000 |
|
|
|
50,000 |
|
Investments |
|
|
62,905 |
|
|
|
50,441 |
|
Working capital |
|
|
170,203 |
|
|
|
255,620 |
|
Total assets |
|
|
303,980 |
|
|
|
381,590 |
|
Revenue interest
liability |
|
|
275,949 |
|
|
|
257,039 |
|
Convertible notes, net of
issuance costs |
|
|
259,080 |
|
|
|
258,280 |
|
Common stock |
|
|
65 |
|
|
|
61 |
|
Accumulated deficit |
|
|
(1,229,432 |
) |
|
|
(1,106,377 |
) |
Total stockholders'
deficit |
|
|
(291,698 |
) |
|
|
(196,944 |
) |
ESPERION
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months Ended June 30, |
|
Six Months EndedJune 30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
13,578 |
|
|
|
$ |
10,610 |
|
|
|
$ |
26,932 |
|
|
|
$ |
16,960 |
|
|
Collaboration revenue |
5,263 |
|
|
|
30,049 |
|
|
|
10,745 |
|
|
|
31,677 |
|
|
Total Revenues |
18,841 |
|
|
|
40,659 |
|
|
|
37,677 |
|
|
|
48,637 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
9,176 |
|
|
|
1,800 |
|
|
|
16,301 |
|
|
|
3,584 |
|
|
Research and development |
32,432 |
|
|
|
25,074 |
|
|
|
56,751 |
|
|
|
53,028 |
|
|
Selling, general and administrative |
29,609 |
|
|
|
46,318 |
|
|
|
59,990 |
|
|
|
107,382 |
|
|
Total operating expenses |
71,217 |
|
|
|
73,192 |
|
|
|
133,042 |
|
|
|
163,994 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
(52,376 |
) |
|
|
(32,533 |
) |
|
|
(95,365 |
) |
|
|
(115,357 |
) |
|
|
|
|
|
|
|
|
|
Interest expense |
(14,266 |
) |
|
|
(11,144 |
) |
|
|
(28,328 |
) |
|
|
(19,269 |
) |
|
Other income, net |
318 |
|
|
|
9 |
|
|
|
638 |
|
|
|
23 |
|
|
Net loss |
$ |
(66,324 |
) |
|
|
$ |
(43,668 |
) |
|
|
$ |
(123,055 |
) |
|
|
$ |
(134,603 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
$ |
(1.05 |
) |
|
|
$ |
(1.67 |
) |
|
|
$ |
(1.98 |
) |
|
|
$ |
(5.16 |
) |
|
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding – basic and diluted |
63,227,406 |
|
|
|
26,225,073 |
|
|
|
62,097,358 |
|
|
|
26,109,089 |
|
|
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