Cardiol Therapeutics, Bayer AG, Fresenius - Who will be the trendsetter in tomorrow's healthcare market?

26 MILLION PEOPLE AFFECTED WORLDWIDE - CARDIOL THERAPEUTICS LOOKS TO SET A NEW STANDARDS IN HEART FAILURE TREATMENT

Have you paid attention to taking care of your heart health today? Worldwide, 26 million people suffer from heart failure, also known as cardiac insufficiency. With this disease, the heart is no longer able to pump as effectively as it should. The heart muscle has to work harder and cannot distribute blood and oxygen around the body as usual. In the long term, this can lead to an enlargement of the heart and a decrease in overall performance. The causes can include persistently high blood pressure, obesity, diabetes, smoking, and atherosclerotic cardiovascular disease.

Once a doctor has diagnosed heart failure, it is usually treated with medication. These include blood pressure-lowering medications, blood thinners or medications for heart rhythm disorders. Often, medications for depression are also prescribed, as patients may struggle with self-blame for neglecting themselves. Even if the symptoms are temporarily alleviated, patients often struggle with severe side effects.

The Canadian life sciences company Cardiol Therapeutics pursues a patient-centered approach: its clinical research focuses on reducing the inflammatory processes in the body of those affected. This also includes reducing the patients' fibrotic processes. As the disease progresses, more and more connective tissue grows around and on the heart muscles, which leads to scarring and hardening. The less fibrosis, the slower the development of the disease and the higher the quality of life of those affected.

This will be made possible soon by the orally administered drug CardiolRx™. The main active ingredient, cannabidiol, is pharmaceutically manufactured. The drug is currently in clinical development for the treatment of various heart diseases. In addition to heart failure, the treatment spectrum also includes myocarditis and pericarditis. Medical research has shown that cannabidiol inhibits inflammation at the intracellular level. CardiolRx™ essentially addresses the root of all evils.

Data specific to heart failure presented at the HFSA Annual Scientific Meeting 2023 in Ohio, USA, showed that the active pharmaceutical ingredient (API) in Cardiol’s novel subcutaneously administered formulation, CRD-38, attenuated deleterious lipid distribution and key markers of cardiac inflammation and remodeling in a model of heart failure with preserved ejection fraction. These findings point to the high therapeutic potential for the treatment of heart failure, a heart disease that remains a leading cause of death and hospitalization in the US and industrialized countries. The associated costs of treating it cost the US healthcare system around USD 30 billion annually.

Cardiol is also developing an orally administered cannabidiol drug candidate, CardiolRx™. The Company has received approval from the US Food and Drug Administration to conduct clinical trials to evaluate the efficacy and safety of CardiolRx™ in two heart diseases: (i) a Phase II pilot study in recurrent pericarditis and (ii) a Phase II study in acute myocarditis, which is a significant cause of heart failure and sudden cardiac death.

Cardiol is well positioned financially: at the close of fiscal year 2023, the Canadian company had cash and cash equivalents of CAD 34.9 million on December 31, 2023, which will fund operations into 2026.

Bayer only top 2 in its own country - Despite fast-track gene therapy in the US

Bayer and its subsidiary Asklepios BioPharmaceutical (AskBio) have been granted fast-track status by the US Food and Drug Administration (FDA) for their gene therapy in development for the treatment of heart failure. The fast-track designation facilitates the development of the gene therapy candidate, as Bayer announced last week. The gene therapy AB-1002 aims to treat advanced heart failure. AB-1002 is a new type of gene treatment that is administered once to the heart. It is designed to help activate a specific protein in the heart that helps block the function of another protein. This other protein is linked to heart problems. Gene therapies are currently among the most expensive drugs in the world.

"The fast-track status for AB-1002 emphasizes the urgency of rapidly advancing new treatment options such as gene therapies for people with heart failure," explains Christian Rommel, Head of Research and Development at Bayer Pharmaceuticals. However, Bayer's investors were unimpressed: the shares are trading at around EUR 26. Boehringer Ingelheim has now overtaken Bayer as Germany's largest pharmaceutical manufacturer. The privately held company has announced total pharmaceutical sales of EUR 20.8 billion for 2023.

Bayer achieved revenue of EUR 18.0 billion in the same period. In addition, Boehringer Ingelheim's animal health business contributed to the overall result with revenue of EUR 4.7 billion, with the anti-flea and tick product for dogs Nexgard generating sales of EUR 1.2 billion. Bayer sold its animal health division in 2019.

Fresenius Kabi expands portfolio: Launch of Tyenne® in the US strengthens presence in the biosimilar market

A conglomerate in healthcare, the Fresenius share offers a diverse portfolio. Fresenius SE comprises the operating units Fresenius Kabi and Fresenius Helios, as well as the subsidiaries Fresenius Vamed and Fresenius Medical Care. Fresenius Kabi offers healthcare products for critically and chronically ill patients. Fresenius Helios is Europe's largest private hospital group. Fresenius Vamed specializes in project and management services for healthcare facilities.

"In the 2023 financial year, we set a decisive course and put Fresenius back on track. We have focused, simplified our structures, and strengthened our financial performance. We will use this momentum to expand our business further," says Michael Sen, Chairman of the Management Board, explaining the Company's current course.

Fresenius Kabi has now announced the launch of Tyenne® in the United States. The Tocilizumab-Biosimilar, which is used for the treatment of various autoimmune diseases such as rheumatoid arthritis, is the first of its kind with FDA approval for intravenous and subcutaneous forms of application. This means it can either be administered through a vein in the arm or injected under the skin. A biosimilar is a biological agent very similar to the approved biologic (reference product, in this case tocilizumab), but not chemically identical. There are no significant differences in efficacy, safety or purity. Biosimilars are typically introduced to the market after the expiration of the patent protection of the reference product to provide more cost-effective alternatives.

Fresenius has already approved two additional biosimilars in the US and has a growing pipeline for autoimmune and oncology indications. The US biosimilars market is expected to grow from USD 9.48 billion in 2022 to USD 100.75 billion in 2029. This forecast from Fortune Business Insights assumes a compound annual growth rate (CAGR) of 40.2% from 2022 to 2029. The Fresenius share is currently trading at EUR 26.63.

The innovative approaches of these three companies offer hope for millions of people worldwide suffering from heart failure, other serious diseases, or cancer. Cardiol Therapeutics stands out for its extraordinary focus on heart health. Its future oral drug, CardiolRx™, reduces inflammatory processes in the body and helps prevent scarring of tissues such as in the heart muscle. The Company has made significant progress in 2023 and early 2024 in providing new therapeutic options for patients with inadequately treated heart disease. Bayer wants a piece of the pie via Fast Track approval by delivering a gene therapy for heart failure patients. Gene therapies are considered particularly costly solutions in the healthcare market. The Company has slipped from 1st to 2nd place in its home country of Germany and has been replaced by the privately managed pharmaceutical company Boehringer Ingelheim. Fresenius, on the other hand, appears to be on track. With the launch of a biosimilar product in the US, numerous patients with autoimmune diseases such as rheumatoid arthritis can be helped. All three companies are shaping the healthcare market of tomorrow. Assuming you were an investor and a heart patient, which doctor would you choose? A general practitioner or a heart specialist? Perhaps this perspective will help you in selecting the appropriate share for your portfolio.