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Esperion Reports First Quarter 2024 Financial Results

– Q1 Total Revenue Grew 467% Y/Y to $137.7 Million, Reflecting Strong Growth Globally –

– Q1 U.S. Net Product Revenue Grew 46% Y/Y to $24.8 Million –

– Q1 Retail Prescription Equivalents Grew 43% Y/Y and 6% Q/Q, Increased Momentum from Label Expansions Expected Throughout 2024 –

– Received U.S. FDA Approval of Broad New Label Expansions for NEXLETOL®(bempedoic acid) Tablet and NEXLIZET®(bempedoic acid and ezetimibe) Tablet, Becoming the First LDL-C Lowering Non-Statins to Prevent Heart Attacks and Reduce Cardiovascular Risk in Primary and Secondary Prevention Patients –

– Received Positive Opinion from the Committee for Medical Products for Human Use (CHMP); European Commission Decision for Expanded Labels Anticipated in Q2 2024 –

– Conference Call and Webcast Today at 8:00 a.m. ET –

ANN ARBOR, Mich., May 07, 2024 (GLOBE NEWSWIRE) — Esperion (NASDAQ: ESPR) today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

“We are proud of our strong start to 2024 and the continued momentum and growth we again delivered in the first quarter,” said Sheldon Koenig, President and CEO. “We posted retail prescription equivalent growth of 43% year-over-year, generated our highest level of revenue yet, and ended the quarter with a cash balance that positions us to capitalize on our new label and deliver long term value growth.”

“We also received FDA approval of our highly anticipated label expansions for NEXLETOL and NEXLIZET, which we believe positions us for a meaningful uptick in growth. As the only oral LDL-cholesterol (LDL-C) lowering non-statins approved for reducing cardiovascular risk in both primary and secondary prevention patients, our expanded labels will enable us to potentially reach more than 70 million new patients in need of an alternative therapy. We believe this approval brings us closer to bridging the statin gap, which encompasses an underserved patient population that is unable to reach their LDL-C goal on current therapies alone.”

“We have prioritized investment in our commercial strategy, including ramping up our sales force, launching our new Lipid Lurker consumer campaign, developing a suite of new promotional materials, and initiating partnerships to provide improved interim access with the payer and patient communities. We’re also pleased to report utilization management criteria updates that will be made by two major payers in the next two months that covers 40 million lives, and anticipate additional payers aligning with our new labels on a weekly basis. Looking to our global ex-U.S. franchise., our partner Daiichi Sankyo Europe (DSE) continued to drive increased sales across newly launched territories, signaling the growth potential of these products globally. In summary, with our reinforced commercial infrastructure and recent payer wins, we are poised for significant growth and I look forward to sharing our progress in the coming quarters.”

First Quarter 2024 Key Accomplishments and Recent Highlights

First Quarter 2024 Financial Results

Total revenue was $137.7 million, compared to $24.3 million for the comparable period in 2023, an increase of approximately 467%.

U.S. net product revenue was $24.8 million, compared to $17.0 million for the comparable period in 2023, an increase of approximately 46%, driven by retail prescription growth of 43%.

Collaboration revenue was $113.0 million, compared to $7.3 million for the comparable period in 2023, an increase of 1,448%, driven by increased tablet sales to our international partners and sales growth within partner territories along with the settlement related milestone payment.

Research and development expenses were $13.4 million, compared to $31.4 million for the comparable period in 2023, a decrease of 57%. The decrease is primarily related to the close-out of our CLEAR Outcomes study.

Selling, general and administrative expenses were $42.0 million, compared to $29.9 million for the comparable period in 2023, an increase of 40%. The increase is primarily related to the ramp up of our sales force ahead of our commercial launch in addition to bonus payments and promotional costs.

Total net income for the quarter was $61.0 million, compared to a net loss of $61.7 million for the comparable period in 2023.

Basic net income per share was $0.36, compared to basic and diluted net loss per share of $0.79 for the comparable period in 2023. Diluted net income per share was $0.34.

As of March 31, 2024, cash and cash equivalents totaled $226.6 million, which includes our legal settlement and $90.7 million in net proceeds from our underwritten public offering in January 2024, compared with $82.2 million as of December 31, 2023.

The Company ended the quarter with approximately 187.9 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 still expects full year 2024 operating expenses to be approximately $225 million to $245 million, including $20 million in non-cash expenses related to stock compensation.

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 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:

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 ≥2% of patients and greater than placebo were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia, and elevated liver enzymes.

Adverse reactions reported in ≥2% of patients treated with ezetimibe (a component of NEXLIZET) and at an incidence greater than placebo in clinical trials were upper respiratory tract infection, diarrhea, arthralgia, sinusitis, pain in extremity, fatigue, and influenza.

In the primary hyperlipidemia trials of NEXLIZET, the most commonly reported adverse reactions (incidence ≥3% and greater than placebo) observed with NEXLIZET, but not observed in clinical trials of bempedoic acid or ezetimibe, were urinary tract infection, nasopharyngitis, and constipation.

The most common adverse reactions in the cardiovascular outcomes trial for bempedoic acid, a component of NEXLIZET and NEXLETOL, at an incidence of ≥2% and 0.5% greater than placebo were hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.

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.

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:
investorrelations@esperion.com

Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438

Esperion Therapeutics, Inc.

Balance Sheet Data
(In thousands)
(Unaudited)

    March 31,
2024
  December 31,
2023
Cash and cash equivalents   $ 226,609     $ 82,248  
Working capital     201,094       44,841  
Total assets     373,060       205,796  
Revenue interest liability     279,883       274,778  
Convertible notes, net of issuance costs     262,033       261,596  
Common stock     188       118  
Accumulated deficit     (1,488,262 )     (1,549,284 )
Total stockholders’ deficit     (294,298 )     (454,994 )
                 

Esperion Therapeutics, Inc.

Statement of Operations
(In thousands, except share and per share data)
(Unaudited)

Three Months Ended
March 31,
2024   2023
Revenues:  
Product sales, net $ 24,756     $ 17,031  
Collaboration revenue   112,979       7,298  
Total Revenues   137,735       24,329  
     
Operating expenses:      
Cost of goods sold   10,075       11,652  
Research and development   13,403       31,381  
Selling, general and administrative   41,988       29,901  
Total operating expenses   65,466       72,934  
     
Income (loss) from operations   72,269       (48,605 )
     
Interest expense   (14,024 )     (14,387 )
Other income, net   2,777       1,273  
Net income (loss) $ 61,022     $ (61,719 )
     
Net income (loss) per common share – basic $ 0.36     $         (0.79 )
Net income (loss) per common share – diluted $         0.34     $         (0.79 )
     
Weighted-average shares outstanding – basic   169,258,564       78,440,266  
Weighted-average shares outstanding – diluted   189,641,251       78,440,266  
     


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