Amarin Corp Plc (AMRN)

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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)