Esperion Reports Fourth Quarter and Full Year 2023 Financial Results
- Strong financial performance in FY23 with U.S. net product revenue growing 40% Y/Y to $78.3 million.
- Q4 U.S. net product revenue increased by 39% Y/Y to $20.8 million.
- Resolution of litigation resulted in $100 million received and potential cost savings.
- Positive interactions with FDA and EMA for cardiovascular indications.
- Equity offering raised $97.8 million to fund commercialization efforts.
- FDA approved updated LDL-C indication for NEXLETOL and NEXLIZET.
- Total revenue grew 54% Y/Y to $116.3 million in FY23.
- Operating expenses for 2024 expected to be $225-245 million.
- None.
Insights
The reported financial growth for Esperion is significant, with a year-over-year increase of 40% in U.S. net product revenue and a 54% increase in total revenue. These figures exceed typical industry growth rates for pharmaceutical companies, which often hover around the high single digits to low teens. The settlement with Daiichi Sankyo Europe (DSE) not only alleviates immediate financial pressure by providing a substantial cash infusion but also promises cost savings and additional revenue streams through expanded collaboration. This strategic move could enhance Esperion's financial stability and fuel further investment in R&D and commercial expansion.
However, a critical observation is the reported net losses, which, despite a decrease from the previous year, still indicate substantial cash burn. The company's reliance on equity offerings for funding, as evidenced by the recent $97.8 million gross proceeds, dilutes existing shareholders. Investors should closely monitor the company's ability to manage operating expenses, projected between $225 million and $245 million for 2024, against its revenue growth to gauge long-term sustainability.
The FDA's approval of updated LDL-cholesterol lowering indications for NEXLETOL and NEXLIZET and the removal of certain limitations in the drugs' usage could potentially broaden the patient base and enhance market penetration. The CLEAR Outcomes exploratory analysis indicating a 21.6% reduction in hsCRP with bempedoic acid use is a noteworthy differentiator in the competitive lipid-lowering therapy market. This could result in increased physician interest and prescription rates, further driving revenue growth.
However, it is important to scrutinize the long-term clinical benefits, particularly cardiovascular outcomes, which are pivotal for widespread adoption by prescribers. The upcoming PDUFA date and anticipated label expansions for cardiovascular risk reduction will be critical milestones that could significantly impact the drugs' market potential and Esperion's valuation.
Esperion's strategic partnerships and international expansion, including the launch of their products in Spain, the Czech Republic and Hong Kong, as well as the ongoing development program with Otsuka in Japan, indicate a robust approach to capturing global market share. The company's preparation for regulatory filings in Canada and Australia further underscores its commitment to international growth.
Yet, the competitive landscape of cholesterol-lowering drugs is fierce, with established players and numerous generics. The success of Esperion's commercial strategy will depend on effective differentiation of NEXLETOL and NEXLIZET based on clinical outcomes, pricing and access to reimbursement. The company's ability to leverage the expanded indications and capitalize on the increased demand for non-statin LDL-lowering therapies will be crucial to gain a foothold in the market and drive long-term profitability.
– FY23 U.S. Net Product Revenue Grew
– Q4 U.S. Net Product Revenue Grew
– Q4 Retail Prescription Equivalents Grew
– Resolved Litigation: Received
– Recent Positive Interactions with FDA and EMA; Proposed Indications for Primary and Secondary Prevention of Cardiovascular Risk and Expanded LDL-C Indication Remain on Track for 1H 2024, with FDA PDUFA Date of March 31 –
– Conference Call and Webcast Today at 8:00 a.m. ET –
ANN ARBOR, Mich., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
“We have recently made major strides as a company, which we believe position us for sustained growth in the short, medium, and long term,” said Sheldon Koenig, President and CEO. “First amongst these was reaching agreement with our valued European partner, DSE, to resolve the outstanding litigation and continue executing our strategy to strengthen our global franchise over time. Our agreement has had an immediate positive impact on our balance sheet, promises substantial cost savings in the years to come, and creates a roadmap for product lifecycle extension in Europe. We are pleased with the near- and long-term value this brings to our organization and look forward to DSE’s continued partnership and strong execution in Europe. We also continue to progress our other partnerships globally, including with Otsuka in Japan, and are on track to making this the blockbuster franchise we expect it to be.”
“We have continued to prioritize our commercial expansion based on our anticipated cardiovascular risk reduction labels from the FDA in March and the EMA in the second quarter. We are confident that our prospective labels will have a material impact on sales.”
“With the cash infusion from our settlement plus our recent capital raise, we are now exceptionally well positioned to fund our commercial launch, increase our coverage and market share, advance our preclinical pipeline, and bring our first-in-class therapies to millions of patients globally who need them. I am proud of our entire organization and its commitment to our long-term vision and look forward to updating you on our progress in the periods ahead.”
Fourth Quarter and Full Year 2023 Key Accomplishments and Recent Highlights
- Announced the resolution of pending litigation with Daiichi Sankyo Europe (DSE) in January 2024, which included near-term cash payments of
$125 million and millions of dollars in anticipated manufacturing cost savings and additional potential revenue streams. The settlement provided for an amendment to the parties’ collaboration agreement and dismissal of their pending legal case. In addition to the near-term cash payments, the settlement terms provide for the transition of Esperion’s manufacturing and supply responsibilities in Europe and other territories to DSE, resulting in significant cost savings and efficiencies. The settlement agreement also expanded the parties’ collaboration agreement to include potential development and commercialization of a triple combination therapy in Europe, which could potentially extend patent exclusivity and corresponding revenue stream, to which Esperion would be entitled tiered royalties.
- Closed on a follow-on equity offering in January 2024, raising gross proceeds of
$97.8 million . Proceeds will enable the Company to fund the ongoing commercialization efforts for NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe), research and clinical development of pipeline candidates, working capital, capital expenditures, and general corporate purposes.
- Announced FDA approval of an updated LDL-cholesterol lowering indication for NEXLETOL and NEXLIZET in December 2023, to include the treatment of primary hyperlipidemia as a qualifier for existing approved populations. In addition, the maximally tolerated qualifier for statin use was removed, and the prior limitation of use stating “the effect of NEXLIZET or NEXLETOL on cardiovascular morbidity and mortality has not been determined” was also removed. Of note, this labeling modification does not impact the full, pending label approvals for cardiovascular risk reduction indications for both drugs, which remain on track for anticipated approval on or before March 31, 2024.
- A pre-specified, exploratory analysis of CLEAR Outcomes was presented at the 2023 American Heart Association Scientific Sessions. The exploratory analysis focused on vascular inflammation, as measured by the inflammatory marker hsCRP as a major determinant of atherosclerotic risk regardless of statin use. In the exploratory analysis, participants with baseline hsCRP in the top
25% of all participants were43% more likely to experience major adverse cardiovascular events (MACE), twice as likely to experience cardiovascular death, and121% more likely to experience all-cause mortality compared to those in the lowest25% . In CLEAR Outcomes, patients who were randomized to bempedoic acid experienced a21.6% reduction in hsCRP compared to placebo at 6 months. This analysis further differentiates bempedoic acid from other non-statin LDL-lowering therapies.
- Reported royalty revenue of
$5.5 million in the fourth quarter, representing a year-over-year increase of139% . Daiichi Sankyo Europe (DSE) launched in Spain and gained approval in the Czech Republic during the fourth quarter of 2023. Daiichi Sankyo Asia and South Central American (DS ASCA) launched in Hong Kong during the fourth quarter of 2023, marking the first territory in that region to launch.
- Our development program with Otsuka in Japan remains on track, with anticipated Japan New Drug Application (JNDA) filing in 2024, and approval and National Health Insurance (NHI) pricing in 2025.
- Preparing for regulatory filings in Canada and Australia.
Fourth Quarter and Fiscal Year 2023 Financial Results
Total revenue was
U.S. net product revenue was
Collaboration revenue was
Research and development expense was
Selling, general and administrative expense was
The Company had net losses of
Basic and diluted net losses per share was
As of December 31, 2023, cash, cash equivalents, and investment securities available-for-sale totaled
The Company ended the quarter with approximately 118.2 million shares of common stock outstanding, excluding 2.0 million treasury shares to be purchased in the prepaid forward transaction as part of the convertible debt financing.
2024 Financial Outlook
The Company expects full year 2024 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. 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 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.
INDICATION
NEXLETOL /NEXLIZET is indicated as an adjunct to diet and statin therapy for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia (HeFH) or atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.
IMPORTANT SAFETY INFORMATION
NEXLIZET is contraindicated in patients with a known hypersensitivity to ezetimibe tablets. Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported with ezetimibe, a component of NEXLIZET.
Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout. Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate.
Tendon Rupture: Bempedoic acid, a component of NEXLIZET and NEXLETOL, is associated with an increased risk of tendon rupture or injury. Tendon rupture occurred within weeks to months of starting NEXLIZET or NEXLETOL. Tendon rupture may occur more frequently in patients over 60 years of age, patients taking corticosteroid or fluoroquinolone drugs, patients with renal failure, and patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Avoid NEXLIZET or NEXLETOL in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in clinical trials of bempedoic acid (a component of NEXLIZET and NEXLETOL) in ≥
Adverse reactions reported in ≥
In clinical trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥
Discontinue NEXLIZET or NEXLETOL when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus. Because of the potential for serious adverse reactions in a breast-fed infant, breastfeeding is not recommended during treatment with NEXLIZET or NEXLETOL. Report pregnancies to the Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Esperion Therapeutics
At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. The status quo is not meeting the health needs of millions of people with high cholesterol – that is why our team of passionate industry leaders is breaking through the barriers that prevent patients from reaching their goals. Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there. Because when it comes to high cholesterol, getting to goal is not optional. It is our life’s work. For more information, visit esperion.com and esperionscience.com and follow us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes Trial
CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet. The CLEAR Program seeks to generate important clinical evidence on the safety and efficacy of bempedoic acid, a first in a class ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential role in addressing additional critical unmet medical needs. More than 60,000 people will have participated in the program by the time of its completion. The CLEAR Program includes 5 label-enabling Phase III studies as well as other key Phase IV studies with the potential to reach more than 70 million people with or at risk for CVD based on elevated LDL-C.
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 net sales, profitability, and growth of Esperion’s commercial products, clinical activities and results, supply chain, commercial development and launch plans, the outcomes and anticipated benefits of legal proceedings and settlements, 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.
Esperion Contact Information:
Investors:
Alexis Callahan
investorrelations@esperion.com
(406) 539-1762
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
| Esperion Therapeutics, Inc. | ||||||||
| Balance Sheet Data | ||||||||
| (In thousands) | ||||||||
| (Unaudited) | ||||||||
| December 31, 2023 | December 31, 2022 | |||||||
| Cash and cash equivalents | $ | 82,248 | $ | 124,775 | ||||
| Investments | — | 42,086 | ||||||
| Working capital | 44,841 | 154,375 | ||||||
| Total assets | 205,796 | 247,939 | ||||||
| Revenue interest liability | 274,778 | 243,605 | ||||||
| Convertible notes, net of issuance costs | 261,596 | 259,899 | ||||||
| Common stock | 118 | 75 | ||||||
| Accumulated deficit | (1,549,284 | ) | (1,340,036 | ) | ||||
| Total stockholders' deficit | (454,994 | ) | (323,778 | ) | ||||
| Esperion Therapeutics, Inc. | |||||||||||||||
| Statement of Operations | |||||||||||||||
| (In thousands, except share and per share data) | |||||||||||||||
| (Unaudited) | |||||||||||||||
| | Three Months Ended December 31, | Year Ended December 31, | |||||||||||||
| | 2023 | 2022 | 2023 | 2022 | |||||||||||
| Revenues: | | | |||||||||||||
| Product sales, net | $ | 20,760 | $ | 14,967 | $ | 78,335 | $ | 55,863 | |||||||
| Collaboration revenue | 11,490 | 3,851 | 37,999 | 19,612 | |||||||||||
| Total Revenues | 32,250 | 18,818 | 116,334 | 75,475 | |||||||||||
| | |||||||||||||||
| Operating expenses: | |||||||||||||||
| Cost of goods sold | 11,452 | 4,160 | 43,267 | 26,967 | |||||||||||
| Research and development | 17,742 | 33,033 | 86,107 | 118,927 | |||||||||||
| Selling, general and administrative | 45,423 | 24,138 | 142,523 | 109,082 | |||||||||||
| Total operating expenses | 74,617 | 61,331 | 271,897 | 254,976 | |||||||||||
| | |||||||||||||||
| Loss from operations | (42,367 | ) | (42,513 | ) | (155,563 | ) | (179,501 | ) | |||||||
| | |||||||||||||||
| Interest expense | (15,057 | ) | (14,329 | ) | (58,976 | ) | (56,810 | ) | |||||||
| Other income, net | 1,080 | 1,355 | 5,291 | 2,652 | |||||||||||
| Net loss | $ | (56,344 | ) | $ | (55,487 | ) | $ | (209,248 | ) | $ | (233,659 | ) | |||
| | |||||||||||||||
| Net loss per common share – basic and diluted | $ | (0.50 | ) | $ | (0.76 | ) | $ | (2.03 | ) | $ | (3.52 | ) | |||
| | |||||||||||||||
| Weighted-average shares outstanding – basic and diluted | 112,403,358 | 73,487,416 | 103,106,616 | 66,407,242 | |||||||||||
FAQ
What was Esperion's U.S. net product revenue growth in FY23?
How much did the Q4 U.S. net product revenue increase by year-over-year?
What financial growth did Esperion report in FY23?
What was the result of the litigation resolution for Esperion?
What recent FDA approval did Esperion receive?
How much did the recent equity offering raise for Esperion?
What is the expected range for Esperion's operating expenses in 2024?
