Esperion Partners with CSL Seqirus to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Australia

Rhea-AI Summary

Esperion Therapeutics (NASDAQ: ESPR) has entered into a license and distribution agreement with CSL Seqirus for exclusive commercialization rights of NEXLETOL® and NEXLIZET® in Australia and New Zealand. The deal includes:

- An upfront payment and milestone payments up to $5 million
- A profitable transfer price for Esperion on product supply
- CSL Seqirus handling commercialization, regulatory approval, and marketing

The partnership targets significant markets where cardiovascular disease affects 1.2 million people in Australia and 175,000 adults in New Zealand. Both medications are indicated to reduce myocardial infarction risk and lower LDL-C in adults with primary hyperlipidemia who cannot take recommended statin therapy.

Positive

• Secured exclusive distribution agreement for two key markets
• Multiple revenue streams: upfront payment, milestones up to $5M, and profitable transfer price
• Access to large market: 1.2M patients in Australia, 175K in New Zealand

Negative

• Significant safety concerns including tendon rupture risk and hyperuricemia
• Requires additional regulatory approvals in both countries
• Revenue potential by patient restrictions (only for statin-intolerant patients)

Insights

Financial Analyst

Esperion's new license and distribution agreement with CSL Seqirus represents a strategically sound expansion of their commercialization footprint into the Australia and New Zealand markets. The deal structure is particularly favorable as it provides multiple revenue streams: an upfront payment, milestone payments totaling approximately $5 million, and ongoing revenue through a profitable transfer price arrangement.

This partnership follows Esperion's asset-light commercialization strategy, allowing them to access new markets without building local sales infrastructure. With 1.2 million Australians and 175,000 New Zealanders affected by cardiovascular disease, this agreement taps into significant markets with established reimbursement systems. The transfer pricing model is particularly noteworthy as it creates predictable, recurring revenue that should generate favorable margins without marketing expenses.

For a company with a market cap of approximately $314 million, securing additional near-term cash and establishing new revenue streams is meaningful. While the $5 million in upfront and milestone payments won't dramatically change Esperion's financial position, the long-term commercial potential could be substantial if their products achieve significant market penetration. This agreement extends Esperion's geographic reach and strengthens their business model through regional partnerships, potentially serving as a template for additional international expansion.

Medical Specialist

Esperion's NEXLETOL and NEXLIZET address a significant unmet need in cardiovascular health by providing treatment options for patients who cannot tolerate statins. These compounds, based on bempedoic acid, work through a liver-specific mechanism that inhibits ATP citrate lyase, a key enzyme in cholesterol biosynthesis upstream from HMG-CoA reductase (the target of statins).

The Australia and New Zealand markets present a substantial opportunity given their high cardiovascular disease burden. In Australia, CVD affects 1.2 million people and remains a leading cause of death, while in New Zealand, approximately 175,000 adults live with cardiovascular disease, accounting for one-third of all deaths.

What makes this partnership clinically significant is the dual indication of these medications: both for primary hyperlipidemia management and for cardiovascular risk reduction in patients with established CVD or at high risk. The recent label expansion to include cardiovascular risk reduction significantly broadens the potential patient population. NEXLIZET's combination formula incorporating ezetimibe offers additional efficacy through complementary mechanisms – reducing both cholesterol production and intestinal absorption.

For clinicians in these markets, these medications will provide valuable alternatives for the substantial population of patients who experience muscle-related side effects with statins or who cannot achieve target LDL-C levels with current therapies.

c

Initial analysis covered key financial implications but could better quantify potential market size in dollar terms. Need deeper context on Australia/NZ reimbursement environment and approval timelines that would affect revenue ramp. Medical analysis accurately explains mechanism of action and clinical positioning but should clarify competitive landscape against existing cholesterol treatments in these markets. Should elaborate on recent label expansion for CV risk reduction which significantly increases commercial opportunity. Financial analysis needs ROI perspective - how meaningful is Australia/NZ market to Esperion's overall global strategy? Both analyses could highlight CSL Seqirus' regional strength and distribution capabilities. Missing context on Esperion's cash position and how this deal affects their runway. Overlooked potential regulatory hurdles and timeline to commercialization. Need to address how this fits with Esperion's other international partnerships and overall commercialization strategy. The $5M upfront/milestone should be contextualized against Esperion's quarterly burn rate. Confirm all information directly supported by article, no speculation on approval timelines or market penetration rates.

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Esperion Therapeutics has expanded its global footprint by entering a license and distribution agreement with CSL Seqirus for its cardiovascular products NEXLETOL and NEXLIZET in Australia and New Zealand. The deal grants CSL Seqirus exclusive commercialization rights in these territories while providing Esperion with multiple revenue streams: an upfront payment, milestone payments totaling approximately $5 million, and ongoing revenue through a profitable transfer price structure. This partnership targets significant markets where cardiovascular disease represents a major health burden - affecting 1.2 million Australians and 175,000 New Zealanders. The agreement allows Esperion to enter these markets without building local sales infrastructure, following an asset-light commercialization strategy. The transfer pricing model is particularly advantageous as it creates predictable, recurring revenue that should generate favorable margins without associated marketing expenses. For Esperion, with a market cap of approximately $314 million, securing additional near-term cash flow and establishing new revenue channels strengthens their financial position. Clinically, NEXLETOL and NEXLIZET address an important unmet need by providing treatment options for patients who cannot tolerate statins. The dual indication of these medications - for primary hyperlipidemia management and cardiovascular risk reduction - significantly broadens their potential patient population. NEXLIZET's combination formula with ezetimibe offers enhanced efficacy through complementary mechanisms. This agreement represents another step in Esperion's global expansion strategy, potentially serving as a template for additional international partnerships while strengthening their recurring revenue model.

– Esperion to Receive an Upfront Payment and Near-Term Milestones Along with a Profitable Transfer Price on Product Sales –

ANN ARBOR, Mich., March 03, 2025 (GLOBE NEWSWIRE) -- Esperion Therapeutics (NASDAQ: ESPR) today announced it has entered into a license and distribution agreement with CSL Seqirus (ASX:CSL) for the exclusive rights to commercialize NEXLETOL^® (bempedoic acid) and NEXLIZET^® (bempedoic acid and ezetimibe) in Australia and New Zealand. Under the terms of the agreement, Esperion will receive an upfront and near-term milestone payments and will be responsible for supplying finished product to CSL Seqirus at a profitable transfer price.

In Australia, cardiovascular disease affects 1.2 million people and is a leading cause of death. In New Zealand, an estimated 175,000 adults are living with cardiovascular disease, and one in three deaths are caused by cardiovascular disease.

"We’re committed to helping reduce the burden of cardiovascular disease in Australia and New Zealand, and we are delighted to be working with Esperion to help make new treatment options available. These products are an important addition to CSL Seqirus' portfolio of in-licensed medicines," said Danielle Dowell, CSL Seqirus Executive Director of Commercial Operations Asia Pacific.

“We are excited to partner with CSL Seqirus to provide physicians and patients with additional options to treat high LDL-C cholesterol and reduce the risk of cardiovascular disease in Australia and New Zealand,” said Sheldon Koenig, President and CEO of Esperion. “This partnership expands the reach of our potentially lifesaving medications to another large market, further enhancing our global reach.”

Details of the Agreement and Financial Terms
Under the terms of the license and distribution agreement, Esperion will grant CSL Seqirus exclusive commercialization rights to NEXLETOL and NEXLIZET in Australia and New Zealand. CSL Seqirus will be responsible for commercialization, including regulatory approval, reimbursement and marketing.

Esperion will receive an upfront payment and be eligible for milestone payments of up to approximately $5 million. Following local regulatory approval, Esperion will be responsible for supplying finished product to CSL Seqirus at a profitable transfer price.

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 ≥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.

About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

In Australia, CSL Seqirus operates the only local manufacturing facility for seasonal and pandemic influenza vaccine, and produces a range of unique medicines in the national interest, including antivenoms and the world’s only human vaccine for Q fever. Our commitment to Australia’s health also extends to providing access to paediatric and adult vaccines, and innovative pharmaceuticals for patients living with allergies, cardiovascular disease, severe pain, dry eye disease, iron deficiency, kidney and rare diseases.

About Esperion Therapeutics
Esperion Therapeutics, Inc. is a commercial stage biopharmaceutical company focused on bringing new medicines to market that address unmet needs of patients and healthcare professionals. The Company developed and is commercializing the only U.S. Food and Drug Administration (FDA) approved oral, once-daily, non-statin medicines for patients who are at risk for cardiovascular disease and are struggling with elevated low density lipoprotein cholesterol (LDL-C). These medications are supported by the nearly 14,000 patient CLEAR Cardiovascular Outcomes Trial. Esperion continues to build on its success with its next generation program which is focused on developing ATP citrate lyase inhibitors (ACLYi). New insights into the structure and function of ACLYi fully enables rational drug design and the opportunity to develop highly potent and specific inhibitors with allosteric mechanisms.

Esperion continues to evolve into a leading global biopharmaceutical company through commercial execution, international partnerships and collaborations and advancement of its pre-clinical pipeline. For more information, visit esperion.com and esperionscience.com and follow Esperion on LinkedIn and X.

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

FAQ

What is the value of milestone payments in Esperion's (ESPR) deal with CSL Seqirus?

The agreement includes milestone payments of up to approximately $5 million, plus an undisclosed upfront payment.

What are the commercialization rights granted to CSL Seqirus for NEXLETOL and NEXLIZET?

CSL Seqirus receives exclusive rights to commercialize both drugs in Australia and New Zealand, including responsibility for regulatory approval, reimbursement, and marketing.

What is the market size for cardiovascular disease in Australia and New Zealand?

Cardiovascular disease affects 1.2 million people in Australia and 175,000 adults in New Zealand.

What are the main safety concerns for NEXLETOL and NEXLIZET according to the PR?

Key safety concerns include hyperuricemia (elevated blood uric acid), risk of tendon rupture, and hypersensitivity reactions including anaphylaxis.