Latest news with #SheldonKoenig
Yahoo
08-05-2025
- Business
- Yahoo
HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada
– 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 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: ABOUT ESPERION THERAPEUTICSEsperion 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 and follow Esperion on LinkedIn and REFERENCES1: 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 INFORMATIONThis 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 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. SOURCE HLS Therapeutics Inc. View original content: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
08-05-2025
- Business
- Cision Canada
HLS Therapeutics partners with Esperion Therapeutics to commercialize NEXLETOL® and NEXLIZET® in Canada
– 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 NEXLIZET 1. 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: 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 and follow Esperion on LinkedIn and 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 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. SOURCE HLS Therapeutics Inc.
Yahoo
06-05-2025
- Business
- Yahoo
Esperion Reports First Quarter 2025 Financial Results
Advanced development of two triple combination products in the U.S. with bempedoic acid, ezetimibe, and either atorvastatin or rosuvastatin, which remains on track for commercialization in 2027. Supported by published literature, the triple combination products have the potential to provide LDL-C lowering in excess of 60%, which would rival both existing injectable and emerging oral therapies. Implemented new marketing initiatives to reach statin intolerant patients, who represent 30% of the lipid lowering market and expect these efforts to drive prescription growth in the coming quarters. First quarter 2025 script growth increased 2% sequentially compared with fourth quarter 2024, reflecting a flat lipid lowering market that was impacted by seasonal headwinds due to changes in Medicare Part D and higher out-of-pocket costs as patients need to meet their annual insurance deductibles. More than 30 plans, including several of the nation's largest insurers, improved formulary positioning across 361 distinct formularies, including removal of prior authorizations, implementation of electronic step edits and new formulary additions. Expanded the Company's reimbursement team from five to 15 field specialists, enhancing support for both providers and patients. Continued to strengthen access and reimbursement support for NEXLETOL and NEXLIZET ® (bempedoic acid and ezetimibe), driving greater confidence among payers and healthcare providers. 'We were especially pleased to share our exciting news regarding pipeline expansion at our recent R&D Day, where we unveiled our promising research supporting lead development candidates, including ESP-1336, for the treatment of Primary Sclerosing Cholangitis (PSC), a market estimated to be greater than $1 billion,' added Koenig. 'Throughout the first quarter, we continued to make important progress advancing our three pillars for growth: revenue growth, portfolio expansion and pipeline advancement,' stated Sheldon Koenig, President and CEO of Esperion. 'We were excited to surpass our one millionth prescription for our bempedoic acid products in the U.S. and, while the overall lipid market was flat in the first quarter of 2025, we are implementing initiatives to drive growth by introducing new marketing around statin intolerance and leveraging recent inclusion in clinical guidelines. Importantly, we have increased our field reimbursement specialists three-fold to ensure that physicians can write prescriptions with confidence in its coverage.' ANN ARBOR, Mich., May 06, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today reported financial results for the first quarter ended March 31, 2025, and provided a business update. – Conference Call and Webcast Today at 8:00 a.m. ET – – Bempedoic Acid Earned Level 1a Recommendations in the 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients with Acute Coronary Syndromes – – Q1 2025 Total Revenue of $65.0 Million, a Decrease of 53% Y/Y; Adjusting for One Time Milestone Received in Q1 2024, Total Revenue Grew 63% Y/Y – Story Continues Global Expansion The Company's partner in Japan, Otsuka Pharmaceutical Co., Ltd. is on track for expected approval and National Health Insurance pricing in the second half of 2025. Esperion's European partner Daiichi Sankyo Europe (DSE) continues to show strong revenue growth and market penetration for NILEMDO ® (bempedoic acid) and NUSTENDI ® (bempedoic acid and ezetimibe), providing increased royalty revenue and underscoring the significant market opportunity for Esperion's bempedoic acid products worldwide. DSE's royalty revenue increased 8% sequentially to $10.5 million, validating the continued opportunity in Europe for sales of NILEMDO and NUSTENDI. DSE received approval of NILEMDO for expanded cardiovascular risk reduction in Switzerland in Q1 2025. Neopharm Israel filed a New Drug Application for marketing approval of NEXLETOL and NEXLIZET in Q1 2025. The Company's previously filed New Drug Submissions to Health Canada for NEXLETOL and NEXLIZET are on track for review with an expected market approval in the fourth quarter of 2025. R&D Pipeline Esperion recently hosted an R&D Day where the Company highlighted internal R&D capabilities with globally and wholly owned next-generation candidates targeting liver and kidney disease. The Company unveiled its promising research supporting lead development candidates for the treatment of PSC. Pre-clinical data confirms that the Company's highly specific allosteric ACLY inhibitor has been shown to reduce markers of liver injury, inflammation and fibrosis across multiple PSC-relevant pre-clinical models. PSC represents a large unmet medical need with no approved therapies and significant market potential that is estimated to be in excess of $1 billion annually. Eligibility for Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration. Estimated prevalence of approximately 76,000 diagnosed PSC patients across the U.S. and Europe as of 2024. An archive of the event is available on the Investor section of the Esperion website and can be accessed here. Guidelines and Publications Guidelines 2025 ACC/AHA/ACEP/NAEMSP/SCAI Guideline for the Management of Patients With Acute Coronary Syndromes High-intensity statin therapy is recommended for all patients with Acute Coronary Syndromes (ACS), and with the option to initiate concurrent ezetimibe. A non-statin lipid-lowering agent (e.g., ezetimibe, evolocumab, alirocumab, inclisiran, bempedoic acid) is recommended for patients already on maximally tolerated statin who have a low-density lipoprotein cholesterol level of <70 mg/dL (1.8 mmol/L). It is reasonable in this high-risk population to further intensify lipid-lowering therapy if the low-density lipoprotein cholesterol level is 55 to <70 mg/dL (1.4 to <1.8 mmol/L) and patient is already on a maximally tolerated statin. Bempedoic acid earned Level 1a recommendations (the strongest guidance indicating strong recommendation where benefit greatly outweighs risk) for the following: In patients with ACS who are already on maximally tolerated statin therapy with LDL-C ≥ 70 mg/dL, a non-statin lipid lowering therapy (LLT) is recommended to reduce the risk of major adverse cardiac events (MACE). In patients with ACS who are statin intolerant, a non-statin is recommended to lower LDL-C and reduce MACE. There was no preferential guidance given among non-statins for either recommendation above allowing physicians and patients to use the option that is best based on an individual basis. Bempedoic acid earned a Level 2a recommendation (moderate evidence exists and a recommendation is reasonable) for: In patients with ACS who are already on maximally tolerated statin therapy with LDL-C 55-69 mg/dL, a non-statin LLT is recommended to reduce the risk of MACE. Publications Bays H, et al. 'Bempedoic Acid for Prevention of Cardiovascular Events in People With Obesity: A CLEAR Outcomes Subset Analysis' published in Journal of the American Heart Association: Nearly 45% of patients in CLEAR Outcomes had obesity (body mass index greater than or equal to 30 kg/m 2 ) at the start of the study. In this analysis, not only was bempedoic acid a safe and well-tolerated option, but patients with obesity treated with bempedoic acid were 23% less likely to experience MACE-4 (CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization) compared to placebo. Laufs U, et al. 'Characteristics and Outcomes of Patients With and Without Statin-Associated Muscle Symptoms Treated with Bempedoic Acid in the CLEAR Outcomes Trial' published in Journal of Clinical Lipidology: This post-hoc analysis demonstrates bempedoic acid was safe and well tolerated with comparable reductions in both LDL-C and hsCRP irrespective of their history of statin associated symptoms prior to treatment randomization (muscle only symptoms, non-muscle related side effects or both). Patients who reported statin associated muscle symptoms at baseline, regardless of randomization to bempedoic acid or placebo, had higher rates of discontinuation, higher rates of skeletal muscle adverse events and had impaired quality of life suggesting this patient population requires more focused clinical management. First Quarter 2025 Financial Results Revenue Total revenue was $65.0 million, compared to $137.7 million for the comparable period in 2024, a decrease of 53%, driven by the settlement agreement milestone with DSE received in the three months ended March 31, 2024. Excluding the settlement agreement milestone, total revenue grew 63% from the comparable period. U.S. net product revenue was $34.9 million, compared to $24.8 million for the comparable period in 2024, an increase of 41%. Collaboration revenue was $30.1 million, compared to $113.0 million for the comparable period in 2024, a decrease of 73%, driven by the settlement agreement milestone, offset partially by increases in royalty sales within our partner territories and product sales to our collaboration partners from our supply agreements. Excluding the settlement agreement milestone, collaboration revenue grew 97% from the comparable period. R&D Expenses Research and development expenses were $12.6 million, compared to $13.4 million for the comparable period in 2024, a decrease of 6%. Selling, General and Administrative (SG&A) Expenses Selling, general and administrative expenses were $43.0 million, compared to $42.0 million for the comparable period in 2024, an increase of 2%. Net (Loss) Income. Total net loss was of $40.5 million, compared to net income of $61.0 million for the comparable period in 2024, respectively. Net (Loss) Income Per Share. Basic and diluted net loss per share was $0.21, compared to basic and diluted net income per share of $0.36 and $0.34, for the comparable period in 2024. Cash and Cash Equivalents. As of March 31, 2025, cash and cash equivalents totaled $114.6 million compared to $144.8 million as of December 31, 2024. The Company ended the quarter with approximately 196.7 million shares of common stock outstanding, excluding 2.0 million treasury shares. 2025 Financial Outlook The Company expects full year 2025 operating expenses to be in the range of $215 million to $235 million, including approximately $15 million in non-cash expenses related to stock compensation. Conference Call and Webcast Information Esperion will host a conference call and webcast at 8:00 a.m. ET to discuss the financial results and business progress. A live audio webcast can be accessed on the investor and media section of the Esperion website. 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 ≥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 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 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@ (734) 887-3903 Media: Tiffany Aldrich corporateteam@ (616) 443-8438 ESPERION Therapeutics, Inc. Balance Sheet Data (In thousands) (Unaudited) March 31, 2025 December 31, 2024 Cash and cash equivalents $ 114,633 $ 144,761 Working capital 47,812 91,765 Total assets 324,029 343,821 Royalty sale liability 296,219 293,610 Convertible notes, net of issuance costs 151,541 151,320 Long-term debt 141,449 140,971 Common stock 197 196 Accumulated deficit (1,641,484 ) (1,601,029 ) Total stockholders' deficit (426,211 ) (388,722 ) ESPERION Therapeutics, Inc. Statement of Operations (In thousands, except share and per share data) (Unaudited) Three Months Ended March 31, 2025 2024 Revenues: Product sales, net $ 34,913 $ 24,756 Collaboration revenue 30,082 112,979 Total Revenues 64,995 137,735 Operating expenses: Cost of goods sold 31,538 10,075 Research and development 12,557 13,403 Selling, general and administrative 42,996 41,988 Total operating expenses 87,091 65,466 (Loss) income from operations (22,096 ) 72,269 Interest expense (19,431 ) (14,024 ) Other income, net 1,072 2,777 Net (loss) income $ (40,455 ) $ 61,022 Net (loss) income per common share - basic $ (0.21 ) $ 0.36 Net (loss) income per common share - diluted $ (0.21 ) $ 0.34 Weighted-average shares outstanding - basic 196,127,948 169,258,564 Weighted-average shares outstanding - diluted 196,127,948 189,641,251
Yahoo
20-03-2025
- Business
- Yahoo
Esperion Aligns with U.S. Food and Drug Administration to Initiate Phase 3 Clinical Trials of Bempedoic Acid in Pediatric Heterozygous and Homozygous Familial Hypercholesterolemia
– Confirms Sufficient Data to Complete Phase 2 Clinical Study Enrollment and Advance to Phase 3 Studies in Both Heterozygous and Homozygous Familial Hypercholesterolemia – – Establishes Pediatric Path Forward to Start and Complete Phase 3 Trial and Secure Additional Six-Month Patent Extension Through June 2031 – ANN ARBOR, Mich., March 20, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that following meetings with the U.S. Food and Drug Administration (FDA), it has gained alignment on a regulatory path forward for initiating Phase 3 studies of bempedoic acid alone and in combination with ezetimibe in pediatric patients with heterozygous and homozygous familial hypercholesterolemia (HeFH and HoFH, respectively). Based on these discussions with the FDA, the Company plans to initiate Phase 3 clinical studies this year. The FDA previously granted orphan drug designation for bempedoic acid in HoFH indication. 'We are delighted to further advance the development of bempedoic acid for children with familial hypercholesterolemia (FH) and are pleased the FDA has indicated that we have adequate data to proceed into Phase 3 clinical trials,' stated Sheldon Koenig, President and CEO of Esperion. 'In addition, this alignment supports our commitment to broaden the reach of our bempedoic acid products as part of our lifecycle management plan, providing the opportunity to extend our patent protection for an additional six months for these important therapies,' added Sheldon Koenig. About CLEAR Path 2 and CLEAR Path 3 StudiesCLEAR Path 2 (in children with HeFH) and CLEAR Path 3 (in children with HoFH) are Phase 3, randomized double-blind, placebo-controlled, multicenter studies to evaluate the efficacy and safety of bempedoic acid with and without concurrent ezetimibe in children with HeFH or HoFH and LDL-C ≥130 mg/dL (3.4 mmol/L) while on protocol defined optimum dose of a statin. Each study is a 52-week design where patients will be randomized 2:1 to treatment or control for 24 weeks, followed by 28 weeks of an open-label extension period. About Heterozygous Familial Hypercholesterolemia (HeFH) and Homozygous FH (HoFH)HeFH and HoFH are the two types of FH, a genetic condition that causes high cholesterol from birth and if untreated leads to early, aggressive atherosclerotic cardiovascular disease. HeFH is the more common form occurring in 1 in 250 births and results from inheriting a gene that causes FH from one parent. If left untreated, cardiovascular disease can develop during middle adulthood. HoFH is the rarer form of the disease, an orphan indication, occurring in 1 in 300,000 births and results from inheriting a FH gene from both parents. HoFH results in higher cholesterol levels, which are often more difficult to treat as cardiovascular disease can begin as early as in childhood if untreated. In both HeFH and HoFH, the processing of LDL-C is disrupted due to these gene mutations, which leads to dangerously high levels of LDL-C. Both HeFH and HoFH are underdiagnosed and undertreated but with early detection and continued development of LDL-C therapies for patients starting at an early age, there is hope that patients with FH can control their LDL cholesterol and reduce their risk of cardiovascular disease. About Esperion TherapeuticsEsperion 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 and follow Esperion on LinkedIn and X. Forward-Looking StatementsThis 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 Veneziainvestorrelations@ (734) 887-3903 Media: Tiffany Aldrich corporateteam@ (616) 443-8438
Yahoo
03-03-2025
- Business
- Yahoo
Esperion Partners with CSL Seqirus to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Australia
– 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 TermsUnder 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 INFORMATIONNEXLIZET 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 SeqirusCSL 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 TherapeuticsEsperion 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 and and follow Esperion on LinkedIn and X. Forward-Looking StatementsThis 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 Veneziainvestorrelations@ (734) 887-3903 Media: Tiffany Aldrich corporateteam@ (616) 443-8438
