Esperion (NASDAQ: ESPR) today reported financial results for the
third quarter ended September 30, 2022 and provided a business
update.
“During the third quarter of 2022 our team has
remained focused on closing out our unprecedented CLEAR Outcomes
trial,” said Sheldon Koenig, President and Chief Executive Officer
of Esperion. “We completed the last patient, last visit for the
study in October and we remain on track to report topline results
in January 2023, with comprehensive study results targeted to be
presented at the American College of Cardiology 72nd Annual
Scientific Sessions in March 2023. As we look ahead to what will be
a transformational period for Esperion, we believe positive results
will confirm the ability of bempedoic acid to lower cardiovascular
risk and change the cardiovascular disease treatment
landscape.”
Third Quarter 2022 Key Accomplishments and
Recent Highlights
- Announced that bempedoic acid was recommended by the American
College of Cardiology expert consensus decision pathway as an
important oral non-statin for LDL-C (Low density lipoprotein
cholesterol) lowering in ASCVD (atherosclerotic cardiovascular
disease).
- Reduced selling, general and administrative expenses by 36%
Year over Year while still delivering on our commitment to drive
RPE growth (2.4% Quarter over Quarter).
- Collaboration partner, Daiichi Sankyo Europe, announced new
data presented at the European Society of Cardiology Congress in
August 2022 from its multinational prospective, observational
study, SANTORINI, demonstrating the persistent need among eligible
patient populations to attain guideline-recommended LDL-C levels.
Simulation study results further indicate that the addition of
bempedoic acid on top of ezetimibe could result in significantly
more patients achieving recommended LDL-C goals, potentially
reducing their risk of cardiovascular events.
- Company hosting virtual R&D Day on November 9, 2022, to
highlight pipeline programs featuring Global Scientific Leaders C.
Michael Gibson, MS, MD (Harvard Medical Research Institutes) and
Professor Peter Libby, MD (Brigham and Women’s Hospital and Harvard
Medical School) who will discuss our investigational programs,
including our landmark CLEAR Outcomes trial for bempedoic acid,
oral PCSK9 inhibitor, and Next Generation ATP citrate lyase
inhibition (ACLYi) platform in people suffering from
cardiovascular, hepatorenal and metabolic diseases, as well as
inflammation, and oncology.
- The CLEAR Path 1 Pediatric Clinical Trial began activating
sites in August 2022. CLEAR Path 1 is a Phase 2 clinical trial
investigating bempedoic acid in patients 6-17 years of age with
heterozygous familial hypercholesterolemia (HeFH).
Third Quarter 2022 Financial
Results
Total revenue for the third quarter ended September
30, 2022, was $19.0 million and $56.7 million for the nine months
ended September 30, 2022, compared to $14.4 million and $63.0
million for the comparable periods in 2021, an increase of 32% and
a decrease of 10%, respectively. The increase for the third quarter
ended September 30, 2022 is related to increases in net U.S.
product revenue, royalty revenue, and product sales to
collaboration partners under our supply agreements. The decrease
for the nine months ended September 30, 2022 is due to a one-time
milestone payment of $28.0 million 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 third quarter ended
September 30, 2022, was $14.0 million and $40.9 million for the
nine months ended September 30, 2022, compared to $10.9 million and
$27.9 million for the comparable periods in 2021, an increase of
28% and 47%, respectively.
Royalty revenue for the third quarter ended
September 30, 2022, was $1.6 million and $4.2 million for the nine
months ended September 30, 2022, compared to $1.2 million and $2.8
million for the comparable periods in 2021, an increase of
approximately 33% and 50%, 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 third
quarter ended September 30, 2022, were $29.1 million and $85.9
million for the nine months ended September 30, 2022, compared to
$25.3 million and $78.4 million for the comparable periods in 2021,
an increase of 15% and 10%, respectively. The increase is primarily
related to an increase in CVOT costs as we achieved 100% MACE
accumulations and continued close-out activities.
Selling, general and administrative expenses for
the third quarter ended September 30, 2022, were $25.0 million and
$84.9 million for the nine months ended September 30, 2022,
compared to $39.3 million and $146.6 million for the comparable
periods in 2021, a decrease of 36% and 42%, respectively. These
decreases reflect savings from the transformative plan implemented
in the fourth quarter of 2021.
Esperion had net losses of $55.1 million for the
third quarter of 2022 and $178.2 million for the nine months ended
September 30, 2022, compared to net losses of $69.4 million and
$204.0 million for the comparable periods in 2021. Esperion had
basic and diluted net losses per share of $0.81 for the third
quarter of 2022 and $2.78 for the nine months ended September 30,
2022, compared to basic and diluted net losses per share of $2.62
and $7.78 for the comparable periods in 2021.
As of September 30, 2022, cash, cash equivalents,
restricted cash and investment securities available-for-sale
totaled $239.3 million compared with $309.3 million on December 31,
2021.
Esperion ended the quarter with approximately 71.7
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. You can also visit the Esperion
website to listen to the call via live webcast. A recorded version
will be available under the same link immediately following the
conclusion of the conference call. Already registered? Access with
your PIN here.
A live audio webcast can be accessed on the
investors 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
TrialCLEAR Outcomes is a Phase 3, event-driven,
randomized, multicenter, double-blind, placebo-controlled trial
designed to evaluate whether treatment with NEXLETOL reduces the
risk of cardiovascular events in patients with or who are at high
risk for cardiovascular disease with documented statin intolerance
(inability to tolerate 2 or more statins, one at a low dose) and
elevated LDL-C levels (fasting blood LDL-C ≥ 100 (2.6 mmol/L). The
study, which includes over 14,000 patients at over 1,200 sites in
32 countries, accumulated the targeted 1,620 primary major adverse
cardiovascular events (MACE-4) in August 2022.
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 are not 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. 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)
|
September 30,2022 |
|
December 31,2021 |
Cash and cash equivalents |
$ |
159,399 |
|
|
$ |
208,892 |
|
Restricted cash |
|
50,000 |
|
|
|
50,000 |
|
Investments |
|
29,942 |
|
|
|
50,441 |
|
Working capital |
|
179,440 |
|
|
|
255,620 |
|
Total assets |
|
312,827 |
|
|
|
381,590 |
|
Revenue interest
liability |
|
284,684 |
|
|
|
257,039 |
|
Convertible notes, net of
issuance costs |
|
259,487 |
|
|
|
258,280 |
|
Common stock |
|
72 |
|
|
|
61 |
|
Accumulated deficit |
|
(1,284,549 |
) |
|
|
(1,106,377 |
) |
Total stockholders'
deficit |
|
(294,100 |
) |
|
|
(196,944 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Esperion
Therapeutics, Inc.
Statement of
Operations(In thousands, except share and per
share data)(Unaudited)
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember
30, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Revenues: |
|
|
|
|
|
|
|
Product sales, net |
$ |
13,964 |
|
|
$ |
10,895 |
|
|
$ |
40,896 |
|
|
$ |
27,855 |
|
Collaboration revenue |
5,016 |
|
|
3,514 |
|
|
15,761 |
|
|
35,191 |
|
Total Revenues |
18,980 |
|
|
14,409 |
|
|
56,657 |
|
|
63,046 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of goods sold |
6,506 |
|
|
5,558 |
|
|
22,807 |
|
|
9,142 |
|
Research and development |
29,143 |
|
|
25,331 |
|
|
85,894 |
|
|
78,359 |
|
Selling, general and administrative |
24,954 |
|
|
39,265 |
|
|
84,944 |
|
|
146,647 |
|
Total operating expenses |
60,603 |
|
|
70,154 |
|
|
193,645 |
|
|
234,148 |
|
|
|
|
|
|
|
|
|
Loss from
operations |
(41,623 |
) |
|
(55,745 |
) |
|
(136,988 |
) |
|
(171,102 |
) |
|
|
|
|
|
|
|
|
Interest expense |
(14,153 |
) |
|
(13,654 |
) |
|
(42,481 |
) |
|
(32,923 |
) |
Other income, net |
659 |
|
|
13 |
|
|
1,297 |
|
|
36 |
|
Net loss |
$ |
(55,117 |
) |
|
$ |
(69,386 |
) |
|
$ |
(178,172 |
) |
|
$ |
(203,989 |
) |
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
$ |
(0.81 |
) |
|
$ |
(2.62 |
) |
|
$ |
(2.78 |
) |
|
$ |
(7.78 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding – basic and diluted |
67,806,292 |
|
|
26,455,209 |
|
|
64,021,248 |
|
|
26,225,730 |
|
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