FACT-MASTER
2月前
Amgen released 4th quarter details today with a significant increase in sales of Repatha:
https://www.reuters.com/business/healthcare-pharmaceuticals/amgen-profit-beats-estimates-next-maritide-studies-start-by-mid-year-2025-02-04/
"The company's fourth-quarter sales of Prolia, also known as denosumab, rose 5% to $1.2 billion. Sales of cholesterol-lowering medication Repatha rose 45% to $606 million, while sales of arthritis drug Enbrel were flat at $1 billion."
Amgen's numbers are impressive imo. ESPR mgmt. is wasting valuable time in getting their marketing strategy going,,,,well, i guess that could be a matter of perspective, eg: sk may be thinking "nascar" is great,, however, imo, nothing is working for ESPR, and sk doesn't care.
FACT-MASTER
2月前
Not sure, decided to stop watching and focus on my work related projects and goals - much more satisfying.
Haven't sold any ESPR, and am the type that will go down with the ship ( if necessary, but hope not).
I only skim through the st board now, however i like the idea with Cramer video, and analysts putting forth more blunt questioning at ESPR's quarterly calls. ( think that was Canyon)
I was reading one post by Gary where he elaborated on buying in the 20's and then averaging down to the 2's. I wonder if this is / was the case with institutions as well, and thus a possible reason for the huge issuance of shares, especially in 2024 - to assist institutions in lowering their average cost base on their ESPR share holdings.
As is the case more often then i like, time will tell here.
FACT-MASTER
3月前
and yet more on ACLY inhibition going on at Espervita in the area of liver cancer https://www.espervita.com/science.php ( Gregory Steinberg, PhD - founder), former Esperion founder Roger Newton. https://www.espervita.com/about.php and 2 more Esperion founders, keep reading the last weblink, i'm going to get timed out here in a second.
This Canadian connection is mind boggling, however the dots are connecting now with the OMERS deal, and the convertible financing and everything Canadian.
Now if we can just get that connection with Denmark ( Novo Nordisk) , the story could get very interesting here with ESPR. Being a European based company NVO would know first hand about the uptick in European BA sales going on at DSE.
https://companiesmarketcap.com/cad/novo-nordisk/marketcap/
omg here comes our waitress, gotta run.
FACT-MASTER
3月前
Acknowledgments
The authors would like to thank Dr. Thomas J. Hawke for access to the upright microscope and Dr. Jonathan D. Schertzer for access to and Dr. Nicole G. Barra for calibration of the Bio-Plex instrument. This research was supported by grants awarded to G.R.S. from the Canadian Institutes of Health Research (201709FDN-CEBA-116200), Diabetes Canada (DI-5-17-5302), Esperion Therapeutics, a Tier 1 Canada Research Chair, and a J. Bruce Duncan Endowed Chair in Metabolic Diseases. E.M.D. and J.W. are Canada Vanier scholars. L.K.T. and B.B. are funded by Canadian Institutes of Health Research postdoctoral fellowships.
Author contributions
G.R.S. and S.L.P. developed the original concept of the study. E.M.D., D.C.T.L., M.R.M., E.E.T., D.W., L.K.T., and B.B. performed the experiments. E.A. and J.M.K. completed blinded assessment of liver pathology scoring. J.W. and R.F. performed transcriptome analysis. J.S.V.L. provided intellectual contributions. E.M.D. and J.W. analyzed data. E.M.D., J.W., and G.R.S. wrote the manuscript. All authors provided comments and approved of the final manuscript.
Declaration of interests
G.R.S. has received research funding from Esperion Therapeutics, Nestle, Cambrian Biosciences, Novo Nordisk, Poxel Pharmaceuticals, and Espervita Therapeutics; honoraria and/or consulting fees from Astra Zeneca, Cambrian Biosciences, Eli-Lilly, Esperion Therapeutics, Fibrocor Therapeutics, Poxel Therapeutics, and Merck; and is a founder and shareholder of Espervita Therapeutics. S.L.P. is an employee and shareholder of Esperion Therapeutics.
https://www.cell.com/cell-reports-medicine/fulltext/S2666-3791(23)00360-9
FACT-MASTER
3月前
Targeted gene expression profiling identifies additive downregulation of fibrosis-related molecular pathways that are predictive of NASH resolution
To determine the transcriptional differences between our treatment cohorts, we examined the expression of 760 genes implicated in 49 fibrosis-related pathways using the nCounter Fibrosis v.2 Panel. Differential expression analysis comparing Lira, BemA, and combination treatment to vehicle controls yielded 249, 132, and 263 differentially expressed genes, respectively (Figures S2A; Table S1). Combination treatment resulted in the greatest number of downregulated genes, significantly reducing the expression of 172 genes compared with 97 and 86 by Lira and BemA alone, respectively. Of these, 56 genes were uniquely altered by combination treatment, 113 genes overlapped between all treatment cohorts, and 3 genes were upregulated by Lira but downregulated in the combination cohort (Figures S2B; Table S2). Conversely, 8 genes were uniquely upregulated by combination treatment (Figure S2C). Over-representation analysis of the uniquely downregulated and overlapping genes, which we defined as additive if the effect size was largest in the combination treatment cohort, identified seven disease processes of interest related to inflammation, fibrosis, and wound healing (Figures S2D; Table S3). Next, we utilized a more comprehensive approach to identify gene sets altered by combination treatment by using all genes in the nCounter panel (Figure S2E).31 Combination treatment led to reductions across 17 pathways with hierarchical clustering identifying reductions in overarching disease processes related to fibrosis (e.g., collagen biosynthesis and modification, myofibroblast regulation), inflammation (e.g., chemokine signaling, cytokine signaling), and wound healing (e.g., phagocytic cell function, angiogenesis), which was consistent with pathway annotation analysis (Figure 3A).
FACT-MASTER
3月前
Combination of Lira and BemA results in additive benefits on liver steatosis, ballooning, and fibrosis
In comparison to the vehicle group, Lira and Lira+BemA reduced the percentage of liver fat by 36% and 47%, respectively (Figure 2A), and triglycerides by 69% and 81%, respectively (Figure 2B). Consistent with these observations, steatosis scores from H&E sections were reduced with Lira (63%) and Lira+BemA treatments (74%) (Figures 2C and 2D). Hepatocellular ballooning scores were reduced with Lira by 56% and with Lira+BemA by a remarkable 94% (Figures 2C and 2E). Lira and Lira+BemA reduced lobular inflammation scores to a similar degree (~50%) (Figures 2C and 2F). In sum, the NAFLD activity score (NAS) was reduced by 56% by Lira and by 75% by Lira+BemA (NAS; Figure 2G). Importantly, Lira and Lira+BemA treatment groups reduced fibrosis area assessed using PSR (40% and 44%, respectively) (Figures 2C and 2H) and had fewer (Lira: 1 of 9) or no (Lira+BemA: 0 of 9) moderate zone 3 perisinusoidal fibrosis compared with vehicle-treated mice (4 of 8) (Figures 2C and 2I).
FACT-MASTER
3月前
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
3月前
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
3月前
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
3月前
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
4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
4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."
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