FACT-MASTER
6日前
ESPR: Publication of interest
( feel free to post on st )
https://pubmed.ncbi.nlm.nih.gov/37585218/
Abstract
Importance: Adenosine triphosphate citrate lyase (ACLY) is a key regulatory enzyme of glucose metabolism, cholesterol and fatty acid synthesis, and the inflammatory cascade. Bempedoic acid, an ACLY inhibitor, significantly reduces atherogenic lipid markers, including low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, and apolipoprotein B. Additional effects of ACLY inhibition include antitumor growth; reduction of triglycerides and proinflammatory molecules such as high-sensitivity C-reactive protein; less insulin resistance; reduction of hepatic lipogenesis; and weight loss.
Observations: While numerous ACLY inhibitors have been identified, most of the clinical data have focused on bempedoic acid. The Cholesterol Lowering via Bempedoic Acid, an ACL-Inhibiting Regimen (CLEAR) program was a series of phase 3 clinical trials that evaluated its effects on lipid parameters and safety, leading to US Food and Drug Administration approval in 2020. CLEAR Outcomes was a phase 3, double-blind, randomized, placebo-controlled trial in individuals with a history of statin intolerance, serum LDL-C level of 100 mg/dL or higher, and a history of, or at high risk for, cardiovascular disease. Bempedoic acid modestly reduced the primary 4-way cardiovascular composite end point as well as the individual components of myocardial infarction and coronary revascularization but did not reduce stroke, cardiovascular death, or all-cause mortality. Rates of gout and cholelithiasis were higher with bempedoic acid, and small increases in serum creatinine, uric acid, and hepatic-enzyme levels were also observed.
Conclusions and relevance: ACLY inhibition with bempedoic acid has been established as a safe and effective therapy in high-risk patients who require further LDL-C lowering, particularly for those with a history of statin intolerance. The recently published CLEAR Outcomes trial revealed modest reductions in cardiovascular events with bempedoic acid, proportional to its LDL-C lowering, in high-risk individuals with statin intolerance and LDL-C levels of 100 mg/dL or higher. The additional effects of ACLY inhibition have prompted a more thorough search for novel ACLY inhibitors for conditions such as cancer, hypertriglyceridemia, chronic inflammation, type 2 diabetes, fatty liver disease, obesity, and metabolic syndrome. Similarly, therapies that reduce fatty acid synthesis are being explored for their use in cardiometabolic conditions.
FACT-MASTER
6日前
ESPR: Press Release January 9/24
https://www.esperion.com/news-releases/news-release-details/esperion-host-virtual-key-opinion-leader-event-wednesday-january
Esperion to Host Virtual Key Opinion Leader Event on Wednesday, January 22, 2025, at 11:30 a.m. ET.
January 9, 2025
PDF Version
Back to Newsroom
– Leading Physician Expert to Discuss Continued Unmet Need in LDL-Cholesterol Management to Prevent Cardiovascular Disease –
ANN ARBOR, Mich., Jan. 09, 2025 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced it will host a virtual key opinion leader (KOL) event to discuss the real-world use of NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe).
The event will be led by LeAnne Bloedon, VP, Head of Clinical Development at Esperion and will feature a discussion with:
Patrick Moriarty, M.D., Professor of Medicine at The University of Kansas Medical Center in Kansas City, Kansas and Director of Clinical Pharmacology at the Atherosclerosis & Lipid-Apheresis Center.
Registration for the KOL webinar can be found here. A live audio webcast can be accessed on the investor and media section of the Esperion website. 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.
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.
Esperion Contact Information:
Investors:
Alina Venezia
investorrelations@esperion.com
(734) 887-3903
Media:
Tiffany Aldrich
corporateteam@esperion.com
(616) 443-8438
FACT-MASTER
1週前
Interesting what was not said in yesterday's news release here:
What are your goals for 2025?
I have three goals for 2025 that will lead us into an even brighter future. First, to continue to inform healthcare providers about our currently marketed products as well as expanding patient access and education for patients on their treatment options for uncontrolled LDL cholesterol.
Nothing new here, just staus quo, Nascar?
Second, continue to solidify our presence outside the U.S. by working with current partners and launching into other desirable world markets.
What? no mention of working within the U.S.? Does this mean that we can expect an announcement next week at the JP Morgan conference regarding a U.S.,/ North American, ( maybe Aussies too) partnership?? That would make sense given the way this statement has been made.
(current partners = DS = outside U.S./North America
Third, expanding our portfolio both through new partnerships and our Next Gen Program, which is exploring new therapeutic opportunities in ATP-citrate lyase (ACLY) biology, with the goal to develop next-generation inhibitors optimized to address multiple life-threatening diseases.
imo, this means a "new" partner that will partner ( with funding) for the Next Gen Program - likely the same partner that partner's up for U.S./North American territorries.
#1 and #2 are basically done,or require little management from ESPR, #3 can be accomplished by one action of acquiring a big pharma company partner for firstly, the nexlizet/nexletol/ba territories of the U.S./North America, and then secondly, the same partner to fund the Next Gen ba Program. I suspect a U.S based partner, Merck or Pfizer - - just a best guess, imo.
FACT-MASTER
1週前
ESPR: Article of interest January 6/24
(thank you Gary st)
https://www.biopharmadive.com/spons/an-evolution-in-leadership-and-vision-for-this-pharma-company/735711/
An evolution in leadership and vision for this pharma company
Published Jan. 6, 2025
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Abstract background to represent molecules.
Mi-Tah / Shutterstock
Esperion Therapeutics
Sponsored content
By Esperion Therapeutics
About four years ago, Sheldon Koenig was thinking about retiring. After spending decades in leadership roles at different pharmaceutical companies, he’d led a successful career focused largely on cardiovascular therapeutics. Along the way, he’d endured his own personal challenges with health—including a battle with cancer, which led him to discover he also had high cholesterol.
But before he made the decision to leave the workforce, he was offered a job with Esperion Therapeutics and saw the potential to make an even greater impact on heart health. “The opportunity to lead a company with both the challenges and the potential to provide a much-needed alternative to current treatments in cardiology was too great to turn down,” says Koenig. He joined the company as chief operating officer in 2020 and in 2021 was promoted to president and chief executive officer.
The years that he’s been at the helm of Esperion have been a period of transformation for the company, which recently received FDA approval for broad new label expansions for its products. Koenig sat down with BioPharma Dive to talk about what’s changed—and what’s next—with the ever-evolving Esperion.
What drew you to working at Esperion in 2020?
I have been fortunate to spend most of my professional career working in cardiovascular health and it is a personal passion of mine to bring life-saving medicines to patients in need. People forget that cardiovascular disease remains the No. 1 cause of death for both men and women in the U.S. and worldwide. At Sanofi S.A., I served as senior vice president and head of the cardiovascular franchise. Prior to that, I was vice president and global brand leader for the cardiovascular division of Merck & Co. taking on roles of increasing responsibility within the company’s cardiovascular and thrombosis franchises.
CEO Sheldon Koenig
Esperion CEO, Sheldon Koenig
However, it is my own battle with cancer, where I have truly witnessed the transformative power of medical breakthroughs and the invaluable role they play in prolonging and improving the lives of countless individuals. This personal connection has only strengthened my resolve to contribute to the advancement of medical knowledge and the development of progressive treatments.
When I was approached by Esperion, I was serving as executive vice president and chief commercial officer at Portola Pharmaceuticals until it was acquired by Alexion in August 2020. At that time, I was toying with the idea of retirement, but when I was presented with the Esperion opportunity it made me realize I still had more to accomplish.
How has your experience with cancer, and your overall health journey, shaped you as a business leader?
Ironically, it was while I was under treatment for cancer that my oncologist recommended I see a cardiologist about my high LDL cholesterol. From my professional experience I was well aware of the risks of elevated LDL. Today, I can speak with customers, investors and colleagues not only about the strong science behind our brands but also from my personal experience and success taking an Esperion product, myself.
Since becoming president and CEO in 2021, what are some of your proudest accomplishments?
While there have been many accomplishments leading up to 2024, this has been a truly transformational year for the company. First, we received FDA approval for an expanded label for our products that significantly increased the potential patient population of the previous highly restrictive indication. Simultaneous with pursuing the expanded label approval, we doubled Esperion’s existing sales force to prepare for the launch of the expanded indications. We also developed and launched an innovative and primarily digital marketing campaign to target and reach the widest possible audience of healthcare providers and patients utilizing impactful characters known as the “Lipid Lurkers.”
Outside the U.S., we also solidified our relationship with our European partner, Daiichi Sankyo Europe (DSE), which led to DSE obtaining a label expansion for both brands in Europe. In Japan, our partner, Otsuka Pharmaceuticals, met the primary endpoint in Phase 3 clinical trials, moving the approval forward for that country. These are all exciting developments that illustrate how Esperion is poised for growth.
What are your goals for 2025?
I have three goals for 2025 that will lead us into an even brighter future. First, to continue to inform healthcare providers about our currently marketed products as well as expanding patient access and education for patients on their treatment options for uncontrolled LDL cholesterol. Second, continue to solidify our presence outside the U.S. by working with current partners and launching into other desirable world markets. Third, expanding our portfolio both through new partnerships and our Next Gen Program, which is exploring new therapeutic opportunities in ATP-citrate lyase (ACLY) biology, with the goal to develop next-generation inhibitors optimized to address multiple life-threatening diseases.
Looking further ahead, what’s your vision for Esperion?
Esperion is priming to become more than a cardiovascular company by exploring broad spectrum opportunities in categories with no current standard of care. While I can’t say too much on that topic yet, I can say that what lies ahead is incredibly exciting.
In the more immediate future, we are thrilled to be presenting at the 2025 JPM Healthcare Conference. Esperion will have some news to share, including details on our upcoming R&D Day in the spring and developments in our pipeline. We look forward to meeting other innovators in the industry at the conference. For those who are unable to attend, our presentation will be available to anyone through a link on esperion.com.
Esperion discovers, develops and commercializes innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases. To learn more visit esperion.com and esperionscience.com.
FACT-MASTER
1月前
ESPR: Esperion Announces $210 Million Convertible Debt Financing
https://finance.yahoo.com/news/esperion-announces-210-million-convertible-110000526.html
Esperion Therapeutics, Inc.
ANN ARBOR, Mich., Dec. 13, 2024 (GLOBE NEWSWIRE) -- Esperion (the “Company”) (NASDAQ: ESPR) today announced that it entered into privately negotiated exchange and subscription agreements (the “Agreements”) with certain holders of its outstanding 4.00% Convertible Senior Subordinated Notes due 2025 (the “2025 Notes”). Pursuant to the Agreements, Esperion will issue $100 million aggregate principal amount of its 5.75% Convertible Senior Subordinated Notes due 2030 (the “New Notes”) consisting of (a) approximately $57.5 million principal amount of New Notes, along with approximately $153.4 million in cash, issued in exchange for approximately $210.1 million principal amount of the 2025 Notes (the “Exchange Transactions”) and (b) approximately $42.5 million principal amount of New Notes for cash (the “Subscription Transactions”), in each case, pursuant to exemptions from registration under the Securities Act of 1933, as amended (the “Securities Act”).
The Exchange Transactions and the Subscription Transactions are expected to close concurrently on or about December 17, 2024, subject to customary closing conditions. Following the closing of the Exchange Transactions, approximately $54.9 million in aggregate principal amount of 2025 Notes will remain outstanding with terms unchanged.
Esperion will not receive any cash proceeds from the Exchange Transactions. In exchange for issuing the New Notes pursuant to the Exchange Transactions, Esperion will receive and cancel the 2025 Notes. Esperion estimates that the gross cash proceeds from the Subscription Transactions will be approximately $42.5 million, before subtracting fees and expenses in connection with the Exchange Transactions and the Subscription Transactions. Esperion intends to use the net proceeds from the Subscription Transactions for general corporate purposes.
The New Notes will represent the senior unsecured obligations of Esperion and will pay interest semi-annually in arrears on each June 15 and December 15, commencing on June 15, 2025, at a rate of 5.75% per annum. The New Notes will mature on June 15, 2030 (the “Maturity Date”), unless earlier converted, redeemed or repurchased. Holders will have the right to convert their notes only upon the occurrence of certain events or after March 15, 2030. Esperion will have the right to elect to settle conversions by paying or delivering, as applicable, cash, shares of its common stock or a combination of cash and shares of its common stock. The initial conversion rate is 326.7974 shares of common stock per $1,000 principal amount of notes, which represents an initial conversion price of approximately $3.06 per share of common stock. The conversion rate and conversion price will be subject to adjustment upon the occurrence of certain events. The indenture governing the New Notes includes certain restrictive covenants that limits Esperion’s ability to incur additional indebtedness, subject to certain exceptions.
The New Notes will be redeemable, in whole or in part, for cash at Esperion’s option at any time, and from time to time, on or after December 20, 2027 and prior to the forty-first (41st) scheduled trading day immediately before the Maturity Date, but only if the last reported sale price per share exceeds 130% of the conversion price for a specified period of time and certain other conditions are satisfied. The redemption price will be equal to the principal amount of the New Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date.
In addition, if Esperion undergoes a “fundamental change” (as defined in the indenture governing the New Notes), subject to certain conditions, holders may require Esperion to repurchase for cash all or part of their New Notes in principal amounts of $1,000 or an integral multiple thereof. The repurchase price will be equal to the principal amount of the New Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date.
The New Notes will be issued only to persons who are reasonably believed to be institutional “accredited investors” within the meaning of Rule 501 of Regulation D under the Securities Act and “qualified institutional buyers” as defined in Rule 144A promulgated under the Securities Act. The New Notes and any of Esperion’s common stock issuable upon conversion of the New Notes have not been registered under the Securities Act or under any state securities laws and may not be offered or sold without registration under, or an applicable exemption from, the registration requirements of the Securities Act and any applicable state securities laws.
The Exchange Transactions will be funded in part with proceeds from the Company’s new $150 Million Senior Secured Term Loan Credit Facility with Athyrium Capital Management, which was entered into on December 13, 2024.
J. Wood Capital Advisors LLC served as exclusive placement agent for the New Notes.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the New Notes, or any other securities, and will not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any state or any jurisdiction.
FACT-MASTER
1月前
Neopharm link:
https://www.neopharmisrael.co.il
Another 4th quarter/24 achievement - nice job Sheldon and ESPR mgmt.!
EXCERPT from above link:
"Our Objectives
Neopharm actively seeks in-licensing, distribution and commercial collaboration opportunities for marketing and distributing innovative prescription medications.
Our objective is to find business partners that share our vision and values and that want to establish a presence in our market
Our focus is on innovative pharmaceuticals, biologicals, vaccines and orphan drugs in diversified therapeutic areas such as: hematology, oncology, immunology, gastroenterology, neurology, endocrinology, dermatology, wound care, transplantation, pain treatment and others.
Our Advantages
We have a proven track record of successful launches, superior market access, reimbursement and short time to market. We accomplish this by leveraging our numerous assets, including market expertise, existing financial resources, a powerful operational network and Israel’s best-in-class platform for marketing and sales. Our deep understanding of all governmental bodies, health institutes and professionals across all therapeutic areas also help drive our success.
We create value for our partners through creativity, innovation, identifying opportunities, taking the initiative, and providing advanced solutions, while always maintaining the highest standards. Our long-term relationships are based on uncompromising service, professionalism, reliability, integrity and transparency, with a commitment to collaborative leadership
Join other leading multinational pharmaceutical companies who have benefited from our one-stop-shop solutions."
FACT-MASTER
1月前
ESPR: Esperion Partners with Neopharm to Commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Israel
https://finance.yahoo.com/news/esperion-partners-neopharm-commercialize-nexletol-130000597.html
Esperion Therapeutics, Inc.
– Esperion to Receive an Upfront Payment and Near-Term Milestones Along with Tiered Royalties on Product Sales –
– Israel-Based Commercial Organization Brings Successful Track Record Commercializing Pharmaceutical Products for More Than 80 Years –
ANN ARBOR, Mich., Dec. 12, 2024 (GLOBE NEWSWIRE) -- Esperion Therapeutics (NASDAQ: ESPR) today announced it has entered into a licensing agreement with Neopharm Israel for the exclusive rights to commercialize NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) in Israel. Under the terms of the agreement, Esperion will receive an upfront and near-term milestone payments and will be eligible to receive tiered royalties on sales of NEXLETOL/NEXLIZET in Israel.
“We are excited to bring the cardiovascular benefits of NEXLETOL and NEXLIZET to the millions of Israelis at risk of heart attacks and cardiovascular disease, which remain the leading cause of death globally,” said Efi Shnaidman, CEO at Neopharm. “We look forward to partnering with the Esperion team as they share our commitment to bringing innovative new medicines to patients. At Neopharm, we have a successful track record bringing new therapies to market in Israel and are confident we can build the market in Israel to establish NEXLETOL and NEXLIZET as efficacious and safe therapeutic options that will help Israeli patients reach their LDL-C goals and reduce their cardiovascular risk.”
“We are very pleased to partner with Neopharm as they have a long history of successfully commercializing innovative medicines in Israel,” said Sheldon Koenig, President and Chief Executive Officer of Esperion. “This agreement expands our global reach and reinforces Esperion’s commitment to helping patients at risk for cardiovascular and cardiometabolic diseases.”
Details of the Agreement and Financial Terms
Under the terms of the licensing agreement, Esperion will grant Neopharm exclusive commercialization rights to NEXLETOL and NEXLIZET in Israel, Gaza, and West Bank. Neopharm will be responsible for commercialization in these areas.
Esperion will receive a one-time upfront cash payment within thirty (30) Calendar Days following the signing of agreement with Neopharm. Additionally, Esperion will receive a one-time payment within thirty (30) Calendar Days following the grant of the Marketing Approval (MA) and inclusion for the first time in the National Healthcare Reimbursement Basket (NHB) without any access limitations beyond those in the MA. Finally, Esperion will receive royalties on net territory sales.
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.
FACT-MASTER
1月前
The connection is with Alnylam Pharmaceuticals where he led the commercialization of LEQVIO for Hypercholesterolemia. So although it may not be his present field of interest, he knows the space.
Interestingly, he was just hired by Jefferies as a senior adviser.
ESPR has previously (January 2024) entered into Underwriting Agreements with Jefferies, so it is likely Maraganore is/will be aware of ESPR.
Any recommendations he would make, imo, could be highly influential in the marketplace.
Most of the previous analysts buy reports / target prices have been ignored by the marketplace, we just happen to have a good week here at the same time Wainwright re-iterating their buy and $16 target, imo.
Yes, time will tell if the gains stick.
Thanks for posting, stick around
fm
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