Esperion Reports Third Quarter 2024 Financial Results and Provides a Business Update
Esperion (ESPR) reported strong Q3 2024 financial results with total revenue increasing 52% year-over-year to $51.6 million. U.S. net product revenue grew 53% to $31.1 million, driven by retail prescription growth. Total retail prescription equivalents increased 12% and new to brand prescriptions grew 18% from Q2. The company expanded product labels, scaled up commercial team, and strengthened balance sheet by monetizing European royalties. Over 165 million lives now have updated utilization management criteria aligned to new labels across Commercial, Medicare and Medicaid payers. Cash and cash equivalents totaled $144.7 million as of September 30, 2024.
Esperion (ESPR) ha riportato forti risultati finanziari per il terzo trimestre del 2024, con un incremento del fatturato totale del 52% rispetto all'anno precedente, raggiungendo i 51,6 milioni di dollari. Le entrate nette da prodotto negli Stati Uniti sono cresciute del 53%, raggiungendo i 31,1 milioni di dollari, trainate dalla crescita delle prescrizioni al dettaglio. Il totale delle equivalenti di prescrizioni al dettaglio è aumentato del 12% e le nuove prescrizioni a marchio hanno registrato una crescita del 18% rispetto al secondo trimestre. L'azienda ha ampliato le etichette dei prodotti, ha potenziato il team commerciale e ha rafforzato il bilancio monetizzando le royalty europee. Oltre 165 milioni di vite hanno ora criteri di gestione dell'utilizzo aggiornati allineati alle nuove etichette per i pagatori Commerciali, Medicare e Medicaid. La liquidità e le disponibilità liquide ammontavano a 144,7 milioni di dollari al 30 settembre 2024.
Esperion (ESPR) reportó sólidos resultados financieros en el tercer trimestre de 2024, con un incremento del 52% en los ingresos totales en comparación con el año anterior, alcanzando los 51,6 millones de dólares. Los ingresos netos por productos en EE. UU. crecieron un 53% hasta los 31,1 millones de dólares, impulsados por el crecimiento de las recetas minoristas. El total de equivalentes a recetas minoristas aumentó un 12% y las nuevas recetas de marca crecieron un 18% desde el segundo trimestre. La compañía amplió las etiquetas de los productos, escaló su equipo comercial y fortaleció su balance mediante la monetización de regalías europeas. Más de 165 millones de vidas ahora cuentan con criterios de gestión de utilización actualizados alineados a las nuevas etiquetas entre los pagadores comerciales, Medicare y Medicaid. El efectivo y equivalentes de efectivo totalizaron 144,7 millones de dólares al 30 de septiembre de 2024.
Esperion (ESPR)는 2024년 3분기 강력한 재무 결과를 보고했으며, 총 수익이 전년 대비 52% 증가하여 5,160만 달러에 달했습니다. 미국에서의 순 제품 수익은 53% 증가하여 3,110만 달러에 이르렀으며, 이는 소매 처방의 성장에 힘입은 것입니다. 총 소매 처방의 동등한 수치는 12% 증가하였고, 브랜드 신규 처방은 2분기 대비 18% 증가했습니다. 회사는 제품 라벨을 확장하고 상업 팀을 강화하며 유럽 로열티를 현금화하여 대차대조표를 강화했습니다. 이제 1억 6,500만 이상의 생명이 새 라벨에 맞춰 업데이트된 이용 관리 기준을 보유하고 있습니다. 2024년 9월 30일 기준 현금 및 현금성 자산 총액은 1억 4,470만 달러였습니다.
Esperion (ESPR) a annoncé de bons résultats financiers pour le troisième trimestre 2024, avec une augmentation de 52% des revenus totaux par rapport à l'année précédente, atteignant 51,6 millions de dollars. Les revenus nets de produits aux États-Unis ont augmenté de 53% pour atteindre 31,1 millions de dollars, soutenus par la croissance des prescriptions au détail. Le total des équivalents de prescriptions au détail a augmenté de 12% et les nouvelles prescriptions de marque ont augmenté de 18% par rapport au deuxième trimestre. L'entreprise a élargi les étiquettes de produits, renforcé son équipe commerciale et consolidé son bilan en monétisant les redevances européennes. Plus de 165 millions de vies disposent désormais de critères de gestion d'utilisation mis à jour alignés sur les nouvelles étiquettes des payeurs commerciaux, Medicare et Medicaid. Les liquidités et équivalents de liquidités s'élevaient à 144,7 millions de dollars au 30 septembre 2024.
Esperion (ESPR) berichtete über starke finanzielle Ergebnisse im dritten Quartal 2024, mit einem Anstieg des Gesamtumsatzes um 52% im Jahresvergleich auf 51,6 Millionen Dollar. Der Nettoumsatz aus Produkten in den USA wuchs um 53% auf 31,1 Millionen Dollar, was durch das Wachstum der Einzelhandelsverschreibungen angetrieben wurde. Die Gesamtzahl der Einzelhandelsverschreibungsäquivalente stieg um 12%, und die neuen Markenschreibungen wuchsen im Vergleich zum zweiten Quartal um 18%. Das Unternehmen erweiterte die Produktetiketten, verstärkte das Verkaufsteam und konsolidierte die Bilanz durch die Monetarisierung europäischer Lizenzzahlungen. Über 165 Millionen Menschen haben nun aktualisierte Nutzungskriterien, die auf die neuen Etiketten bei gewerblichen, Medicare- und Medicaid-Zahlungsempfängern abgestimmt sind. Zum 30. September 2024 beliefen sich die liquiden Mittel und Äquivalente auf insgesamt 144,7 Millionen Dollar.
- Total revenue increased 52% YoY to $51.6M
- U.S. net product revenue grew 53% to $31.1M
- Retail prescription equivalents up 12% QoQ
- New to brand prescriptions increased 18% QoQ
- European royalty revenue grew 19% QoQ to $8.9M
- Access to 92% of commercially insured lives
- Cash position improved to $144.7M from $82.2M in December 2023
- Net loss of $29.5M in Q3 2024
- SG&A expenses increased 20% YoY to $40.0M
- Operating expenses guidance maintained at $225-245M for 2024
Insights
The Q3 results show significant momentum with
Key growth drivers include expanded product labels, increased payer coverage reaching
The narrowing net loss to
The commercial execution shows strong market penetration with prescription growth accelerating. The
International expansion progresses well with European sales growth, Japanese market entry planned for 2025 and new approvals in Taiwan. The upcoming American Heart Association presentations will further strengthen the clinical value proposition. The combination of improved access, growing prescriber confidence and expanding global footprint positions the company for sustained growth trajectory.
– Total Revenue Increased
U.S. Net Product Revenue of
– Total Retail Prescription Equivalents Increased
– October 2024 Total Retail Prescription Equivalents Increased
Brand Prescriptions Grew
– Conference Call and Webcast Today at 8:00 a.m. ET –
ANN ARBOR, Mich., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the third quarter ended September 30, 2024, and provided a business update.
“The year to date has been transformational for Esperion. We successfully expanded our product labels, scaled up our commercial team and launched new indications, which have driven double-digit prescription growth every quarter since receiving the new outcome labels. In addition, we substantially strengthened our balance sheet by monetizing the European royalties on our bempedoic acid product sales and allocated the proceeds for the early, discounted payoff and termination of a previous revenue interest facility,” stated Sheldon Koenig, President and CEO of Esperion. “We are confident the advances we made in the third quarter with contracted payers and our innovative outreach to healthcare providers has strengthened our foundation for future growth as we continue to build a sustainable biopharmaceutical company and deliver preventative and life-saving medicines to patients worldwide.”
“We continue to be impressed with and encouraged by the strong adoption and growing product revenue our European partner, Daichi Sankyo Europe (DSE), is generating across Europe bringing the LDL-C lowering benefits of NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid and ezetimibe) to patients at risk for cardiovascular events and expect these successes to be a proxy for the substantial market opportunity in the U.S.,” added Koenig. “We also have a significant market opportunity in Japan where our partner, Otsuka Pharmaceutical, is advancing toward filing for regulatory approval of our bempedoic acid product by the end of 2024 with approval and pricing anticipated in 2025.”
Third Quarter 2024 Key Accomplishments and Recent Highlights
Advanced US Commercialization Initiatives
- Updated utilization management criteria for over 165 million lives now aligned to our new labels across Commercial, Medicare and Medicaid payers.
- New additions to Medicare formularies at Optum/United AARP and CVS/SilverScript coupled with Humana provides access to more than
65% of Medicare insured lives and more than92% of commercially insured lives.
- New additions to Medicare formularies at Optum/United AARP and CVS/SilverScript coupled with Humana provides access to more than
- With key restrictions and access barriers reduced, including prior authorization in some cases, physicians can now prescribe NEXLETOL® (bempedoic acid) and NEXLIZET ® (bempedoic acid and ezetimibe) with increased confidence, positioning the products for higher sales growth in the upcoming quarters and beyond.
- As a result of the combined marketing, managed care and sales initiatives, the Company achieved approximately
18% growth in new to brand prescription and increased total retail prescription equivalents by approximately12% compared to the second quarter, and now has more than 23,500 healthcare practitioners in Q3 2024 writing scripts for NEXLETOL and NEXLIZET.- Building on this foundation, the fourth quarter has shown continued strength as October 2024 total retail prescription equivalents grew
17% and new to brand prescriptions increased20% compared with the first four weeks of the third quarter of 2024.
- Building on this foundation, the fourth quarter has shown continued strength as October 2024 total retail prescription equivalents grew
Significant International Progress
- DSE continued to drive significant prescription growth in Europe during the third quarter, as reflected in the approximately
19% sequential increase in royalty revenue to$8.9 million based on European sales of NILEMDO and NUSTENDI. - Otsuka Pharmaceutical remains on track to file a New Drug Application (NDA) in Japan by the end of the year, with approval and National Health Insurance (NHI) pricing anticipated in 2025.
- Daichi Sankyo Limited, Co., our partner for certain Asian regions, received regulatory approval to market NILEMDO in Taiwan.
- New Drug Applications in Canada are planned for November 2024, with potential submissions and/or partnerships in Australia and Israel expected in the first half of 2025.
Publications and Presentations
- Announced a bolus of data in support of the benefits of bempedoic acid to reduce LDL-C and cardiovascular risk will be presented at the upcoming American Heart Association Scientific Sessions taking place from November 16-18, 2024, in Chicago. The following data will be presented:
- An oral, featured presentation in the Late Breaker/Featured Science track titled “Bempedoic Acid and Limb Outcomes in Statin-Intolerant Patients with Peripheral Artery Disease: New insights from the CLEAR Outcomes Trial” explores the impact of bempedoic acid on reduction of major adverse limb events in patients with peripheral artery disease;
- A poster presentation titled, “Statin Intolerance due to Muscle Symptoms Affects Management of Patients: Insights from the CLEAR Outcomes Trial,” evaluated whether there were differences in statin intolerance symptom history and whether this influenced the clinical course during the CLEAR Outcomes study;
- A poster presentation titled, “Liver Steatosis and Liver Fibrosis Predict Major Adverse Cardiovascular Events in the CLEAR Outcomes Trial,” evaluates whether liver steatosis or liver fibrosis are associated with cardiovascular (CV) outcomes in CLEAR Outcomes, and if so, whether bempedoic acid treatment reduces observed increases in CV risk; and
- A poster presentation titled, “Effectiveness of Lipid-lowering Therapy with Bempedoic Acid plus Ezetimibe in a Real-world Cohort,” evaluates the effectiveness of bempedoic acid and ezetimibe on LDL-C reduction below 100 mg/dL using real-world data.
- Continued to publish a growing body of clinical and scientific data in support of the cardiovascular risk reduction benefits of bempedoic acid.
- DSE reported final, two-year, real-world results from the MILOS German cohort at DGK Herztage 2024 in Hamburg, Germany. The data demonstrated a strong increase in the achievement of LDL-C goals with the addition of bempedoic acid.
- DSE reported final, two-year, real-world results from the MILOS German cohort at DGK Herztage 2024 in Hamburg, Germany. The data demonstrated a strong increase in the achievement of LDL-C goals with the addition of bempedoic acid.
Third Quarter and YTD 2024 Financial Results
Revenue
- Total revenue for the three and nine months ended September 30, 2024, was
$51.6 million and$263.2 million , respectively, compared to$34.0 million and$84.1 million for the comparable periods in 2023, an increase of52% and213% , respectively. - U.S. net product revenue for the three and nine months ended September 30, 2024, was
$31.1 million and$84.2 million , respectively, compared to$20.3 million and$57.6 million for the comparable periods in 2023, an increase of approximately53% and46% , respectively, driven by retail prescription growth of44% and43% . - Collaboration revenue for the three and nine months ended September 30, 2024, was
$20.5 million and$179.0 million , compared to$13.7 million and$26.5 million for the comparable periods in 2023, an increase of approximately50% and575% , respectively, driven by increases in royalty sales within our partner territories, product sales to our collaboration partners from our supply agreements, and revenue recognized from our Settlement Agreement with DSE in the first half of 2024.
R&D Expenses
- Research and development expenses for the three and nine months ended September 30, 2024, were
$10.4 million and$35.3 million , compared to$14.9 million and$68.4 million for the comparable periods in 2023, a decrease of30% and48% , respectively.- The decrease is primarily related to the close-out of our CLEAR Outcomes study.
Selling, General and Administrative (SG&A) Expenses
- Selling, general and administrative expenses for the three and nine months ended September 30, 2024, were
$40.0 million and$126.1 million , compared to$33.2 million and$97.1 million for the comparable periods in 2023, an increase of20% and30% , respectively.- The increase is primarily related to the ramp up of our sales force associated with our commercial launch in addition to bonus payments and promotional costs.
Net Loss. The Company had net losses of
Loss Per Share. Basic and diluted net losses per share was
Cash and Cash Equivalents. As of September 30, 2024, cash and cash equivalents totaled
The Company ended the third quarter 2024 with approximately 195.4 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 reiterates its full year 2024 operating expense guidance, which is expected to be approximately
Conference Call and Webcast Information
Esperion will host a conference call and webcast at 8:00 a.m. ET to discuss these 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 at esperion.com/investor-relations/events. 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
NEXLIZET and NEXLETOL are indicated:
- The bempedoic acid component of NEXLIZET and NEXLETOL is indicated to reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with:
- established cardiovascular disease (CVD), or
- at high risk for a CVD event but without established CVD.
- As an adjunct to diet:
- NEXLIZET, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
- NEXLETOL, in combination with other LDL-C lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in patients with a prior hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Serious hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria have been reported.
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, returning to baseline following discontinuation of treatment. 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 may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders. Discontinue NEXLIZET or NEXLETOL at the first sign of tendon rupture. Consider alternative therapy in patients who have a history of tendon disorders or tendon rupture.
The most common adverse reactions in the primary hyperlipidemia trials of bempedoic acid, a component of NEXLIZET and NEXLETOL, in ≥
Adverse reactions reported in ≥
In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥
The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥
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 Esperion Therapeutics, Inc. Adverse Event reporting line at 1-833-377-7633.
Please see full Prescribing Information for NEXLIZET and NEXLETOL.
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.
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:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
ESPERION Therapeutics, Inc. | ||||||||
Balance Sheet Data (In thousands) (Unaudited) | ||||||||
September 30, 2024 | December 31, 2023 | |||||||
Cash and cash equivalents | $ | 144,717 | $ | 82,248 | ||||
Working capital | 141,682 | 44,841 | ||||||
Total assets | 314,114 | 205,796 | ||||||
Royalty sale liability | 290,623 | — | ||||||
Revenue interest liability | — | 274,778 | ||||||
Convertible notes, net of issuance costs | 262,922 | 261,596 | ||||||
Common stock | 195 | 118 | ||||||
Accumulated deficit | (1,579,711 | ) | (1,549,284 | ) | ||||
Total stockholders' deficit | (370,209 | ) | (454,994 | ) |
ESPERION Therapeutics, Inc. | |||||||||||||||
Statement of Operations (In thousands, except share and per share data) (Unaudited) | |||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||
Revenues: | | | |||||||||||||
Product sales, net | $ | 31,106 | $ | 20,251 | $ | 84,164 | $ | 57,575 | |||||||
Collaboration revenue | 20,526 | 13,718 | 179,037 | 26,509 | |||||||||||
Total Revenues | 51,632 | 33,969 | 263,201 | 84,084 | |||||||||||
| |||||||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 17,286 | 13,377 | 42,970 | 31,815 | |||||||||||
Research and development | 10,397 | 14,885 | 35,261 | 68,365 | |||||||||||
Selling, general and administrative | 39,975 | 33,240 | 126,148 | 97,100 | |||||||||||
Total operating expenses | 67,658 | 61,502 | 204,379 | 197,280 | |||||||||||
| |||||||||||||||
Income (loss) from operations | (16,026 | ) | (27,533 | ) | 58,822 | (113,196 | ) | ||||||||
| |||||||||||||||
Interest expense | (15,082 | ) | (14,995 | ) | (42,829 | ) | (43,919 | ) | |||||||
Loss on extinguishment of debt | — | — | (53,235 | ) | — | ||||||||||
Other income, net | 1,584 | 1,278 | 6,815 | 4,211 | |||||||||||
Net loss | $ | (29,524 | ) | $ | (41,250 | ) | $ | (30,427 | ) | $ | (152,904 | ) | |||
| |||||||||||||||
Net loss per common share – basic and diluted | $ | (0.15 | ) | $ | (0.37 | ) | $ | (0.17 | ) | $ | (1.53 | ) | |||
| |||||||||||||||
Weighted-average shares outstanding – basic and diluted | 194,930,830 | 111,869,478 | 184,366,434 | 99,973,647 |
FAQ
What was Esperion's (ESPR) revenue growth in Q3 2024?
How much did Esperion's (ESPR) prescriptions grow in Q3 2024?
What was Esperion's (ESPR) cash position in Q3 2024?