– These cardiovascular medicines have the potential to address a significant unmet medical need for over half a million Canadians
– HLS will leverage existing organizational capabilities and commercial infrastructure
– Already approved and commercially available in the U.S. and Europe, NEXLETOL/NEXLIZET are under regulatory review in Canada with a decision expected later this year
– Deal terms include $1 million paid upfront and additional milestone payments tied to achievement of regulatory, pricing, reimbursement and commercial sales objectives
TORONTO, May 8, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into an agreement with Esperion Therapeutics Inc. ("Esperion") (NASDAQ: ESPR) to in-license and commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Canada. All financial figures are in U.S. dollars unless otherwise stated.
In Q4 2024, Esperion submitted New Drug Submissions to Health Canada for both NEXLETOL and NEXLIZET1. Under this agreement, HLS will be responsible for obtaining Health Canada approval, which is expected by the end of 2025. NEXLETOL and NEXLIZET are oral medications currently available in the U.S. and several European countries. Initially approved by the U.S. Food and Drug Administration in 2020 to help reduce low-density lipoprotein cholesterol ("LDL-C") levels, their labels were expanded in 2024 to include broader indications for cardiovascular risk reduction in patients who are unable to take recommended statin therapy, supported by data from the CLEAR Outcomes trial.
Current estimates suggest there are over half a million Canadians who could potentially benefit from NEXLETOL or NEXLIZET. This includes patients with elevated LDL-C levels and who are either statin intolerant or who are not at their LDL-C goal despite being on combination therapy with statins and ezetimibe.
"We look forward to working with Esperion to bring these innovative treatments to the many Canadians suffering from, or at risk of, cardiovascular disease," said Craig Millian, CEO at HLS. "Adding NEXLETOL and NEXLIZET to the HLS product portfolio is aligned with our stated BD strategy and will strengthen our position in the Canadian cardiovascular market."
"We are pleased to partner with HLS to provide advanced cardiovascular treatment options to patients across Canada," said Sheldon Koenig, President and CEO of Esperion. "HLS is highly regarded within Canada for their strong capabilities and relationships in the cardiovascular therapeutic area. This collaboration furthers Esperion's commitment to addressing cardiovascular and cardiometabolic diseases globally."
The agreement includes an upfront payment of $1 million, an additional $1 million upon Health Canada approval, customary royalties on future sales, and potential milestone payments tied to pricing and reimbursement and achievement of significant commercial sales targets. HLS will fund all upfront and milestone-based payments, along with associated launch costs, through existing cash reserves without requiring additional financing. Furthermore, the company intends to leverage current commercial infrastructure and does not anticipate a significant increase in operating expenses will be required.
ABOUT HLS THERAPEUTICS INC. Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com
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 follow Esperion on LinkedIn and https://x.com/EsperionIncX.
REFERENCES 1: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada to be confirmed upon approval by Health Canada.
FORWARD LOOKING INFORMATION This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 12, 2025, and Management's Discussion and Analysis dated May 7, 2025, both of which have been filed on SEDAR+ and can be accessed at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.
