Whalatane
11 hours ago
Irshpaddy ...I expect the share buyback to go through . As regards UK regulators concerns ,a simple search would have shown you the following
Here are some key points on how UK regulators view share repurchases:
Market Abuse Regulations: The FCA regulates share buybacks under the Market Abuse Regulation (MAR). MAR sets out rules to prevent market manipulation and insider dealing, which includes rules governing share repurchases. Companies must ensure compliance with these regulations to avoid legal issues.
Disclosure Requirements: Companies engaging in share buybacks must disclose the details of these transactions to the market. This includes the number of shares repurchased, the price paid, and the total value of the buyback. This information helps investors and regulators assess the company's financial health and management's decisions.
Board Approval and Shareholder Communication: Share buybacks typically require approval from the company's board of directors and may also need shareholder approval in certain circumstances. Regulators emphasize the importance of clear communication with shareholders regarding the rationale behind the buyback and its potential impact on the company's financial position.
Market Integrity and Fairness: Regulators are concerned about maintaining market integrity and fairness. They monitor share buybacks to ensure they are not used to manipulate the company's stock price artificially or to mislead investors. Companies must adhere to strict guidelines to prevent such abuses.
Financial Stability and Capital Allocation: Regulators also consider the broader implications of share buybacks on financial stability and capital allocation. Excessive buybacks that jeopardize a company's ability to meet its financial obligations or invest in long-term growth may attract regulatory scrutiny.
Overall, while UK regulators recognize the legitimate use of share buybacks as part of a company's capital management strategy, they enforce rules and guidelines to ensure transparency, fairness, and compliance with market regulations. Companies engaging in share repurchases must navigate these regulatory requirements carefully to avoid legal and reputational risks.
User
What is the difference between UK regulators and US regulators on share buybacks
ChatGPT
The difference between UK regulators and US regulators regarding share buybacks primarily lies in the specific regulations, guidelines, and market dynamics of each jurisdiction. Here are some key differences:
Regulatory Bodies:
UK: In the UK, the Financial Conduct Authority (FCA) oversees share buybacks under the Market Abuse Regulation (MAR) and other relevant guidelines. The London Stock Exchange (LSE) also plays a role in regulating companies listed on its exchange.
US: In the US, share buybacks are regulated by the Securities and Exchange Commission (SEC). The SEC enforces rules and disclosure requirements related to buybacks, including those outlined in Regulation S-K and Regulation M.
Regulatory Framework:
UK: The UK's regulatory framework emphasizes transparency, fair dealing, and preventing market abuse. Companies must comply with disclosure requirements and ensure that buybacks are conducted in a manner that does not manipulate the market or mislead investors.
US: The US regulatory framework for share buybacks also emphasizes transparency and fair dealing. However, there are specific rules governing the timing, pricing, and disclosure of buybacks, such as restrictions on buybacks during certain periods (e.g., blackout periods) and requirements for filing Form 10-Q or 10-K with the SEC.
Legal Environment:
UK: The legal environment in the UK may have different considerations regarding corporate governance, shareholder rights, and fiduciary duties compared to the US. Shareholder activism and engagement are also factors that influence how companies approach buybacks and how regulators view these activities.
US: In the US, shareholder activism and corporate governance practices can impact the way companies conduct share buybacks. Proxy advisory firms and institutional investors often play a significant role in shaping shareholder resolutions and governance policies related to buybacks.
Market Dynamics:
UK: The UK stock market has its unique characteristics, including the presence of the London Stock Exchange and the regulatory landscape specific to the region. Market conditions, investor sentiment, and economic factors influence the frequency and scale of share buybacks in the UK.
US: The US stock market is one of the largest and most liquid in the world, with diverse market participants and regulatory considerations. Buyback activities in the US market can have a significant impact on stock prices, market liquidity, and investor confidence.
Overall, while both UK and US regulators aim to ensure fairness, transparency, and market integrity in share buybacks, the specific regulatory frameworks, legal environments, and market dynamics in each jurisdiction result in differences in how these activities are regulated and perceived. Companies operating in both regions must navigate the relevant regulatory requirements and market expectations when engaging in share buybacks.
User
Are UK regulators concerned about share buybacks for the purpose of inflating low priced shares
Yes, UK regulators are concerned about share buybacks being used for the purpose of inflating low-priced shares. This concern is rooted in the broader objective of preventing market manipulation and maintaining market integrity. Here are some key points regarding this concern:
Market Manipulation: Share buybacks can potentially be used as a tool for market manipulation, especially when they are used to artificially inflate the price of low-priced shares. This can mislead investors and create an inaccurate perception of the company's financial health or market value.
Regulatory Oversight: The Financial Conduct Authority (FCA) in the UK closely monitors share buybacks under the Market Abuse Regulation (MAR) to ensure that they are not used for manipulative purposes. MAR sets out rules and guidelines to prevent market abuse, including activities like price manipulation through share buybacks.
Disclosure Requirements: Companies engaging in share buybacks are required to disclose detailed information about these transactions to the market, including the number of shares repurchased, the price paid, and the total value of the buyback. This transparency helps regulators and investors assess the legitimacy of buyback activities.
Fair Dealing and Investor Protection: UK regulators emphasize fair dealing and investor protection in the context of share buybacks. Companies must conduct buybacks in a manner that does not mislead or harm investors, including avoiding actions that artificially inflate share prices for short-term gains.
Corporate Governance: Share buybacks are subject to scrutiny from a corporate governance perspective as well. Boards of directors and shareholders expect companies to use buybacks responsibly and in the best interests of shareholders and the long-term sustainability of the company.
Overall, while share buybacks are a legitimate financial tool for companies, UK regulators are vigilant about ensuring that they are not used to manipulate markets, inflate share prices artificially, or mislead investors. Companies must adhere to regulatory requirements, transparency standards, and ethical practices when engaging in share buybacks to avoid regulatory scrutiny and maintain market confidence.
User
What are the UK regulators and banks concerns about share buybacks
UK regulators and banks have various concerns about share buybacks, which revolve around financial stability, market integrity, investor protection, and corporate governance. Here are some of the key concerns they may have:
Financial Stability: One of the primary concerns is that excessive share buybacks could impact a company's financial stability. If a company allocates too much capital to buybacks instead of investing in long-term growth, it may weaken its financial position, particularly during economic downturns or when faced with unexpected challenges.
Market Manipulation: Regulators are concerned about the potential for share buybacks to be used for market manipulation. This includes artificially inflating share prices or creating misleading perceptions about a company's financial health or prospects. Such manipulation can harm investors and undermine market integrity.
Liquidity and Capital Adequacy: Banks and regulators also consider the impact of share buybacks on a company's liquidity and capital adequacy. Excessive buybacks can reduce a company's cash reserves and available capital, which may affect its ability to meet financial obligations or pursue strategic initiatives.
Investor Protection: Ensuring that investors are protected and well-informed is a key concern. Regulators require companies to disclose details of share buybacks, including the rationale, timing, pricing, and impact on capital structure. This transparency helps investors make informed decisions and assess the company's financial health.
Corporate Governance: Share buybacks are scrutinized from a corporate governance perspective. Regulators and stakeholders expect boards of directors to act in the best interests of shareholders and the company as a whole. This includes evaluating whether share buybacks are an appropriate use of capital and align with long-term strategic objectives.
Impact on Shareholder Returns: While share buybacks can enhance shareholder returns by reducing the number of shares outstanding, regulators and banks are concerned about the sustainability and effectiveness of buyback programs. They may assess whether buybacks are generating long-term value for shareholders or merely boosting short-term stock prices.
Regulatory Compliance: Companies engaging in share buybacks must comply with regulatory requirements, including those related to market abuse, disclosure, insider trading, and corporate governance. Non-compliance can lead to legal and reputational risks.
Overall, UK regulators and banks aim to strike a balance between allowing companies to use share buybacks as a legitimate capital management tool while ensuring that such activities are conducted responsibly, transparently, and in the best interests of shareholders and the broader financial system.
TalShu
1 day ago
CBB,
Novo Nordisk: a potential Partner / Acquirer?
Novo Nordisk, the first European pharmaceutical company, employs 64,000 people in 80 offices around the world, and markets its products in 170 countries.
In China, it employs:
- +140 research employs
- +1,700 production employees
- +4,400 commercial employs spread over 8 branches
WHAT IS MOST IMPORTANT IS NOVO NORDISK’S KEEN INTEREST in establishing its presence in the cardiovascular space according to its Aspiration 2025.
It is highly advisable to watch the sessions and/or review the (PDF) presentations of Novo’s last March 7th during investors-day dubbed Capital Markets Day 2024, namely:
1) Corporate strategy, purpose and sustainability and
2) Cardiovascular and emerging therapy areas on (https://www.novonordisk.com/investors/capital-markets-day-2024.html).
While Novo Nordisk’s core therapeutic areas remain Obesity and Type 2 diabetes – treated with Wegovy and Ozempic respectively - it highlights that the “Innovative and Therapeutic Focus” of its Aspiration 2025 is to establish presence in cardiovascular and emerging therapy areas.
With regard to the cardiovascular space that accounts for 32% of global deaths, Novo Nordisk seeks to focus its portfolio on multiple targets in key segments:
1. Atherosclerotic cardiovascular disease
a. Dyslipidaemia: Globally, one third of ischemic heart disease is attributable to high cholesterol.
b. Systemic inflammation: Around half of ASCVD patients estimated to have residual inflammatory risk.
c. Uncontrolled and resistant hypertension: a leading risk factor for CVD, HF, CKD and premature death.
2. Heart failure
a. Heart failure with preserved ejection fraction: HFpEF is associated with high morbidity and mortality.
b. Transthyretin amyloid cardiomyopathy: ATTR-CM is a progressive, life-threatening disease.
In this perspective, Novo Nordisk’s investment approach is to build competitive pipelines through:
The near-term focus on:
- maximizing Ziltivekimab; and
- STRENGTHENING PIPELINE THROUGH INTERNAL AND EXTERNAL CANDIDATES.
The long-term focus on pursuing:
- new MoAs; and
- disease modification
At present, Novo Nordisk’s presence in the cardiovascular space is limited to its development pipeline consisting of 6 candidates that are the outcome of selected acquisitions and partnerships. Its three-pronged Ziltivekimab program is in Phase 3 and due to terminate in beginning of 2006, 2007 and 2028. The other five candidates are in either Phases 1 or 2.
Novo Nordisk wants to leverage the overlap of patients in its core therapy area (Obesity and Type 2 diabetes) with ASCVD and Heart failure.
Last March 8, the FDA approved the weight-loss drug Wegovy for lowering the risk of stroke and heart attack in overweight and obese adults who DO NOT have diabetes. It is worthwhile recalling that the American Diabetes Association recommended Vascepa as standard of care in March 2019.
Diabetes drug Ozempic and weight-loss drug Wegovy are chemically known as semaglutide, belonging to a class of drugs called GLP-1 agonists. Originally developed for type 2 diabetes, they also reduce food cravings and cause the stomach to empty more slowly.
Patients who are obese or overweight are at “a higher risk of cardiovascular death, heart-attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health” said FDA.
Millions of people already take Novo’s GLP-1 drugs, but the FDA’s stamp of approval for the heart benefits is likely to open their use to more patients.
So far, initiating and monitoring therapy with drugs like Wegovy has been deferred to the primary care team. At present, cardiology groups need to incorporate these therapies into clinic and build up a clinical workflow to manage dose escalation, side effects, and insurance approval.
Healthcare professionals should monitor patients taking the medicine for kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts, the FDA said.
In November 2023, Novo Nordisk published the full data from a large clinical trial that showed the obesity drug reduced the risk of non-fatal heart attack by 28%, non-fatal stroke by 7% and heart-related death by 15%, compared with a placebo, in patients with pre-existing heart conditions.
In the 17,604-patient trial with a mean duration of 33 months, the difference in heart protective benefits began to appear almost immediately after starting treatment in those who received Wegovy, suggesting the positive impact was due to more than weight loss.
Novo Nordisk’s application for adding Wegovy’s heart benefits to its European approval is currently under review by the European Union’s drug regulator EMA. It expects a decision this year.
Wegovy, which has been shown to help patients lose an average of 15% after 68 weeks of treatment, was first approved by the FDA to treat obesity in June 2021.
Although NOVO NORDISK AIMS at creating the first STAND ALONE CVD DRUG, Wegovy’s list price of $1,349 for a package with a month’s worth of shots, coupled with supply and manufacturing shortages, may still make it interested in considering Vascepa.
As a reminder, to win its proxy war Sarissa proposed achieving three strategic goals in order to bring about a turnaround of Amarin’s business and maximize shareholder value.
Among them was rejecting past management’s “flawed” “subscale commercial strategy” which leads to “the destruction of shareholder value” because for a one-drug company to follow a GIA Strategy globally “a large marketing infrastructure becomes an unavoidable fixed-cost.”
By affirming that Amarin’s “commercialization of one product is inefficient” and “Another company already in primary care and cardiology would likely need little incremental expense to sell Vascepa,” Sarissa clearly inferred that Amarin should either collaborate with or be sold to a BP.
To back its statement, Sarissa presented a comparison of the enterprise value (EV) of Amarin’s $0.5 billion with that of companies with primary care salesforce namely, SANOFI, NOVARTIS, Pfizer, MERCK, Novo Nordisk and Lilly.
Novo Nordisk ranked the second highest with an EV at $309 billion. The latter has almost doubled in 14 months boosted by the sale of diabetes medicine (GLP-1) Ozempic and obesity medication Wegovy. This might have been one weak signal. (See pages 17 & 18 on https://freeamarin.com/wp-content/uploads/2023/02/presentation-slides-opt.pdf)
CaptBeer
1 day ago
Hi North,
I suppose my intent and correlation to the new CP lies within the long historical view of regulatory agencies such as the FDA and the EMA reguarding triglyceride serum levels in patients, and their relationship to CVD risk reduction.
Long before the REDUCE-IT trial and even before the MARINE & ANCHOR trials, the FDA considered TG reduction like LDL-c reduction, as a surrogate for CVD risk reduction. That is precisely why the FDA offered an SPA to Amarin in the ANCHOR trial that guaranteed a CVD label if Amarin promised to be at least 50% enrolled in the REDUCE-IT trial.
Unfortunately for Amarin & us, there were several negative RCT’s whose endpoints were significant TG reductions. The three trials shown below and in the illustration, caused the FDA to change their mind about TG’s as a surrogate for CVD risk reduction. After the infamous ANCHOR ADCOM the FDA quickly (13 days), rescinded the SPA and issued a Clear Response Letter (CRL).
• FIELD (2005, Fibrate)
• ACCORD-Lipid (2010, Fibrate)
• AIM-HIGH (2011, Niacin)
Since that time even more evidence has shown that powerful TG reducing agents like fenofibrates in (PROMINENT, 2022), have shown no clinical ASCVD benefits. As the HealthyWomen CP indicates, it’s past time to revise the CVD wording on fibrate drug labels. In the illustration I posted, I included additional evidence that extends beyond fibrates to niacin’s and mixed EPA/DHA agents.
Omega-3 mixtures may not have yet reached the level of evidence that fibrates have, but nevertheless, after many negative OMG-3 trials and 2 highly successful and one borderline EPA trial, it’s becoming increasingly clear:
“It’s the EPA Stupid.” (It’s a phrase, not a pejorative).
JRoon71
1 day ago
I think these are the key points to take away from our current situation, with the bolded being the most critical...and I agree that Holt is basically buying time until their Plan comes together. Otherwise, they would (like most companies planning for a long future) lay out a well-designed vision and strategic plan to shareholders. In reality, Holt (like KM did) is just talking in platitudes.
Not having a long-term strategic vision indicates that the Sarissa BOD does not intend to take shareholders on a long ride....
Unfortunately, Holt’s narrative projects a low resolution of what he really understands by operational momentum while not outlining what the BOD’s plan is...
As to R&D Holt said he cannot reveal what Amarin is engaged in beyond “Our very important R&D group continues to focus on global regulatory support, market access as well as our scientific publication strategy to support our product globally.”...
In between two “operational momentum” utterances Holt is simply rehashing the same narrative of KM, dressed up in a new “look” ...
Holt is here merely entertaining us; buying time...
In short, what we retain from Holt’s narrative is the BOD’s focus on immediate, short-term, execution...
Shareholders are thus called upon to have faith in the BOD, to believe in what the BOD believes in, namely, having the right plan based on operational momentum to maximize shareholder value and strengthen Amarin’s position for strategic options (understand: partnerships or Buy Out) within the short-term.
TalShu
1 day ago
Ziploc_1,
First of all, allow me to make an addendum to my post.
Curiously, the standard 10-K 2023 paragraph on “Collaboration with Mochida” did not this time refer to any fees paid by Amarin to Mochida during the year (page 8 out of 91).
Such announcement was made through the notes to the consolidated financial statements which stated:
1) “research and development costs include . . . license fees to the Company’s strategic collaboration with Mochida Pharmaceutical Co., Ltd., or Mochida.” (page F-11/F-35);
2) “In January 2023, 2022 and 2021, the Company exercised certain rights under the agreement, resulting in payments of $1.0 million, in each of such periods, to Mochida, which was recorded as research and development expense in the consolidated statement of operation.” (page F-30/F-35).
Secondly, Amarin’s strategic collaboration with Mochida based on the famous 2018 Agreement is shrouded in complete secrecy. Thus, one cannot expect Amarin divulging any information in the forthcoming CC on May 1st.
As a reminder, Patrick Holt made four public appearances since assuming his role as President & CEO on August 18, 2023.
In his maiden public appearance at Cantor Fitzgerald’s Fireside Chat on 26 September he completely avoided answering the first question addressed to him: “What’s your company’s strategic vision? Where’s the company now and where do you want to see it in say three to five years from now?”
Holt did not have answer. He even seemed surprised by it.
IMHO, this was a weak signal. Not having a long-term strategic vision indicates that the Sarissa BOD does not intend to take shareholders on a long ride. We are indeed far away from Karim Mikhaïl’s proposal to accompany shareholders in writing the Third Chapter of the Book of Amarin over not less than fifteen years from cozy tax heaven Zug in Switzerland. This is most welcome.
For Denner, the role of the BOD is to oversee the CEO and not work for the CEO. Thus, Holt’s narrative builds on the founding statement that “For the Board of Directors, the best path forward today is to remain focused on accelerating operational momentum.” This will become Holt’s catchword, repeated over and over again to convey the BOD’s focus on immediate short-term execution to create shareholder value.
Here are some examples:
- “The Sarissa leadership is focusing on enhancing immediate, short-term, operational momentum in all three key geographic areas.” This translates to extending the life cycle in the U.S.; proving revenue uptake in Europe; and promoting global expansion through partnerships which admittedly is in an “early stage.”
- “the most important thing I want to share with you is that fundamentally, we're focused on enhancing operational momentum alongside our cash preservation
approach” that we believe will drive the stock price forward. We're confident that we can achieve this.”
- “We believe we have the right plan based on operational momentum to drive shareholder value.”
- “We believe this focus on operational momentum will maximize shareholder value and position us for the future.”
- “We firmly believe this focus on operational momentum is the best path forward for Amarin and will more strongly position us for future strategic options.
Controlling costs and preserving cash are essential.”
- With regard to M&A, “operational momentum is the best path forward at this time and, as a result, strengthens our position for strategic options.”
- “2023 was a meaningful year for operational momentum.”
- “We believe we have the right plan, focus, and operational momentum to drive shareholder value.”
- “We believe the best path forward for us to both increase our value and put us in the best possible place for future strategic options is, today, to focus on our
current efforts around operational momentum, whether that be in Europe, in the U.S., or in the rest of world.”
Unfortunately, Holt’s narrative projects a low resolution of what he really understands by operational momentum while not outlining what the BOD’s plan is.
As to R&D Holt said he cannot reveal what Amarin is engaged in beyond “Our very important R&D group continues to focus on global regulatory support, market access as well as our scientific publication strategy to support our product globally.”
In between two “operational momentum” utterances Holt is simply rehashing the same narrative of KM, dressed up in a new “look” – for instance, “proving revenue uptake in Europe will be key”; “Look, to speak very frankly, the U.K. is not one of the fastest uptake markets in Europe;” “there's really not one size fits all in Europe;” “We’re in the very early stages, very preliminary stages of reconsidering what might be opportunities for us to reconsider our position in Germany.”
Holt is here merely entertaining us; buying time.
In short, what we retain from Holt’s narrative is the BOD’s focus on immediate, short-term, execution. To put it in his words: “the focus in the immediate term is really on executing what we have in our hands.”
Shareholders are thus called upon to have faith in the BOD, to believe in what the BOD believes in, namely, having the right plan based on operational momentum to maximize shareholder value and strengthen Amarin’s position for strategic options (understand: partnerships or Buy Out) within the short-term.
What is comforting is that Sarissa has gained way over two years, when compared to the Ariad take over, by having had full control of the BOD and a CEO nominated within six months. This may seem to have facilitated the BOD’s stress on the short-term “operational momentum.”
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DMC8
15 hours ago
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