Esperion Reports Second Quarter 2022 Financial Results and Provides Company Update
Esperion reported significant progress in its CLEAR Outcomes Trial, achieving 100% of targeted MACE-4 events, with topline results expected in Q1 2023. In Q2 2022, U.S. product revenue for NEXLETOL and NEXLIZET increased by 28% year-over-year to $13.6 million, while total revenue stood at $18.8 million, reflecting a 54% decline from Q2 2021 due to a one-time payment last year. R&D expenses rose to $32.4 million, driven by trial costs, while SG&A expenses fell 36% to $29.6 million. The company reported a net loss of $66.3 million, improving loss per share to $1.05.
- Achieved 100% of targeted MACE-4 events in CLEAR Outcomes Trial.
- U.S. product revenue grew 28% year-over-year to $13.6 million.
- Royalty revenue increased 50% year-over-year in Q2 2022.
- Total revenue decreased 54% year-over-year to $18.8 million.
- Net losses rose to $66.3 million for Q2 2022.
– Achieved
– U.S. Net Product Revenue of NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets grew
– Retail Prescription Equivalents Grew
ANN ARBOR, Mich., Aug. 02, 2022 (GLOBE NEWSWIRE) -- 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
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
U.S. product revenue for the second quarter ended June 30, 2022, was
Royalty revenue for the second quarter ended June 30, 2022, was
Research and development expenses for the second quarter ended June 30, 2022, were
Selling, general and administrative expenses were
Esperion had net losses of
As of June 30, 2022, cash, cash equivalents, restricted cash and investment securities available-for-sale totaled
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
Esperion expects full-year 2022 operating expenses to be approximately
Conference Call and Webcast Information
Esperion 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 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. 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 Therapeutics
Esperion 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 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 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 Communications
corporateteam@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 Ended June 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 | |||||||||||||||
FAQ
What were Esperion's revenue figures for Q2 2022?
What is the status of the CLEAR Outcomes Trial for Esperion?
How did Esperion's U.S. product revenue perform in Q2 2022?
What were the net losses for Esperion in Q2 2022?
