Esperion (NASDAQ: ESPR) today announced preliminary, unaudited
fourth-quarter 2020 financial results and full-year 2021 operating
expense guidance. Concurrently, the Company announced that it has
entered into a definitive agreement with Serometrix to in-license
its oral, small molecule PCSK9 inhibitor program.
“As a result of our company’s exceptional focus and hard-fought
performance, we enter the new year with a strong foundation and are
building momentum toward our purpose of lipid management for
everybody,” said Tim M. Mayleben, president and chief executive
officer of Esperion. “During 2020, despite the effects of the
COVID-19 pandemic, Esperion took a huge step forward to provide
physicians and patients easy and effective non-statin medicines to
lower bad cholesterol, including the first-ever, fully non-statin
fixed combination drug product, NEXLIZET®. I am excited to
reinforce our commitment to patients with the addition of our oral
PCSK9 inhibitor program, which has the potential to expand oral,
non-statin treatment options even further.”
The small molecule PCSK9 inhibitor program is intended for
development of a convenient, oral medicine. Patients and healthcare
professionals favor oral medicines for ease of administration and
compliance,1 but currently approved PCSK9 inhibitors are biologics
delivered by subcutaneous injection, which, for many patients, are
out of reach or may not be preferred.2,3 An oral PCSK9 inhibitor
has the potential to provide an additional non-statin treatment
option between statins and injectable PCSK9 inhibitors. There are
currently no oral PCSK9 inhibitors available to patients.
PCSK9 (proprotein convertase subtilisin/kexin type 9) is a
protein responsible for regulating LDL receptor expression.
Medicines that inhibit PCSK9 stop LDL receptors from being broken
down, thus increasing the amount of LDL receptors and leading to
removal of LDL-C from the blood. Inhibition of PCSK9 by injectable
products has been clinically proven to reduce LDL-C and major
cardiovascular events, as demonstrated by two completed
cardiovascular outcomes trials (CVOTs) involving more than 46,000
patients.4,5
“Esperion’s new program targets allosteric inhibition of PCSK9,
making our approach mechanistically different from earlier attempts
to develop oral PCSK9 inhibitors,” said Ashley Hall, chief
development officer of Esperion. “The initial biophysical and
cell-based data, as well as initial pharmacokinetic and efficacy
data in preclinical models, indicate a high potential for a
compelling drug profile. In addition to development as a
monotherapy, we plan to pursue a fixed combination drug product
with bempedoic acid in parallel. Clinical research has shown that
bempedoic acid added to an injectable biologic PCSK9 inhibitor
resulted in a mean additional ~30 percent LDL-C lowering compared
to placebo.6 Together, this could be a compelling non-statin
combination tablet for patients in need of further LDL cholesterol
lowering and could provide health care providers and patients a
broader range of oral options.”
Serometrix developed the oral PCSK9 inhibitor program with its
proprietary technology to discover drugs for difficult protein
targets. As part of the agreement, Esperion made an upfront cash
payment of $12.5 million in December to Serometrix, with payments
in future years tied to specific milestones. The Company
anticipates sharing more information later this year on the
potential timing for an Investigational New Drug (IND)
application.
“Serometrix has developed a proprietary platform focused
on targeting protein conformational dynamics. This
capability enabled our allosteric small molecule PCSK9 inhibitor
program and allowed Serometrix to be the first to discover and
patent allosteric small molecule inhibitors for PCSK9,” said Kyle
Monroe, chief executive officer of Serometrix. “We believe
Esperion’s commitment to hyperlipidemia, combined with their track
record in development, make them an ideal strategic partner to
advance this program through clinical development and beyond.”
Preliminary Fourth-Quarter 2020 Net Product Sales
Results and Preliminary Full-Year 2021 Operating Expense
Guidance
Preliminary, unaudited fourth-quarter 2020 net U.S. product
sales are expected to be between $8.0 and $8.5 million.
As of December 31, 2020, cash, cash equivalents, and investment
securities available-for-sale totaled approximately $305 million
and there were approximately 25.9 million shares of common stock
outstanding which excludes the 2.0 million treasury shares
purchased in the prepaid forward transaction as part of the
convertible debt financing.
The Company expects full-year 2021 operating expenses to be
approximately $320 million to $340 million, inclusive of $30
million of non-cash stock-based compensation.
The preliminary unaudited results described in this press
release are estimates only and are subject to revision until the
Company reports its full financial results for the fourth quarter
and full year 2020 in late February.
39th Annual J.P.
Morgan Healthcare Conference
The Company will present at the virtual 39th Annual J.P. Morgan
Healthcare Conference today, Wednesday, January 13, 2021, at 7:30
a.m. Eastern Time. A live audio webcast of this event can be
accessed on the investor relations section of the Esperion website
at investor.esperion.com. A replay of the webcast will be archived
on the Company’s website for 90 days following the event.
Esperion TherapeuticsEsperion is The Lipid
Management Company. Our team of lipid experts works to lower bad
cholesterol by discovering, developing and commercializing
innovative medicines and combinations with established medicines.
We work hard to make our medicines easy to take, easy to get and
easy to have. We are singularly focused on disrupting high
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 the development of the oral PCSK9 inhibitor
program and prospects for its successful development, potential
commercialization plans for bempedoic acid tablet and Esperion’s
projected cash and non-cash operating expenses. 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,
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.
References1 Dibonaventura MD, Wagner JS, Girman
CJ, Brodovicz K, Zhang Q, Qiu Y, Pentakota,SR, & Radican L
(2010). Multinational Internet-based survey of patient preference
for newer oral or injectable Type 2 diabetes medication. Patient
preference and adherence, 4, 397–406.
https://doi.org/10.2147/PPA.S14477
2 Baum SJ, Toth PP, Underberg JA, Jellinger P, Ross J, Wilemon K
(2017). "PCSK9 inhibitor access barriers-issues and
recommendations: Improving the access process for patients,
clinicians and payers". Clinical Cardiology. 40 (4):
243–254. doi:10.1002/clc.22713. PMC 5412679. PMID 28328015.
3 Gina Kolata, "These Cholesterol-Reducers May Save Lives.
So Why Aren’t Heart Patients Getting Them?", The New York
Times, Oct. 2, 2018. Retrieved 18 December 2020.
4 Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD,
Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, and
Pedersen TR (2017). Evolocumab and Clinical Outcomes in Patients
with Cardiovascular Disease. N Engl J Med 2017; 376:1713-1722. DOI:
10.1056/NEJMoa1615664.
5 Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R,
Edelberg JM, Goodman SG, Hanotin C, Harrington RA, Jukema JW,
Lecorps G, et al (2018). Alirocumab and Cardiovascular Outcomes
after Acute Coronary Syndrome. N Engl J Med 2018; 379:2097-2107.
DOI: 10.1056/NEJMoa1801174
6
https://www.globenewswire.com/news-release/2018/03/27/1453515/0/en/Esperion-Announces-Positive-Top-Line-Results-from-Phase-2-Study-of-Bempedoic-Acid-Added-On-to-a-PCSK9-Inhibitor-in-Patients-with-Hypercholesterolemia.html
Contact:Kaitlyn BroscoESPERIONcorporateteam@esperion.com
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