Bayer, BioNxt Solutions, BioNTech – Patents and acquisitions for market penetration

Bayer is investing in the treatment of genetic heart disease in the Japanese market

The Leverkusen-based pharmaceutical and agricultural company Bayer is further expanding its commitment to heart medication. Given the "Bayer nosedive" share, M&A activities are urgently needed to get the Company back on its feet. In a new deal, the Company has secured exclusive rights for the active ingredient Aficamten in Japan. The cooperation and license agreement with the Californian biotech company Cytokinetics includes payments of up to EUR 560 million.

Japan is a particularly attractive market for the development and marketing of heart medication, as the country has a rapidly ageing population. Cardiovascular diseases are also on the increase there. The Japanese healthcare market is also characterized by a comprehensive insurance system that facilitates access to innovative therapies. The local market for heart medicine is expected to grow to almost USD 7 billion by 2029.

The drug is aimed at the treatment of hypertrophic cardiomyopathy (HCM), a usually hereditary heart muscle disease. In HCM, the heart muscles become pathologically thickened, which limits the pumping function of the heart and can lead to sudden cardiac death, especially in young people. Cytokinetics has already submitted an application for approval to the US Food and Drug Administration (FDA) and plans to submit a further application to the European EMA this quarter.

Bayer is now planning a Phase III study with Japanese patients, while Cytokinetics is expanding its ongoing global study to include Japan. In March, the Company acquired European marketing rights for another heart drug, Acoramidis, for up to USD 310 million. These investments underscore Bayer's strategy of strengthening its cardiovascular portfolio in key markets.

BioNxt Solutions is developing a new dosage form for MS drugs

The Canadian biotech company BioNxt Solutions has taken a significant step in patenting its sublingual cancer drugs for the treatment of autoimmune neurodegenerative diseases. Sublingual means "under the tongue" and refers to a form of administration in which the drug dissolves under the tongue and is quickly absorbed through the well-perfused oral mucosa. Following a positive preliminary decision from the European Patent Office (EPO), the Company is now initiating the national patent application in numerous countries.

The patent family, which is 100% owned by BioNxt Solutions, has been determined by the EPO to be novel, useful and non-obvious. Applications are being made in key markets, including the US, Canada, Japan, Australia and New Zealand, as well as in 37 European countries and 8 member states of the Eurasian Patent Organization. Patent protection is expected to last until 2045.

The development is focused on a sublingual cladribine product for the treatment of multiple sclerosis (MS), one of the most common neurodegenerative diseases, along with Alzheimer's, Parkinson's and Huntington's.

Cladribine tablets are already approved in over 75 countries and generated more than USD 1 billion in annual sales in 2023. The sublingual dosage form could be particularly beneficial for MS patients with swallowing difficulties. This approach demonstrates the Company's patient-centered approach. The global MS drug market is projected to grow and reach USD 41 billion by 2033.

To finance further development, the Company has placed a first tranche of a convertible bond in the amount of USD 425,000. The bond has a term of two years and an annual interest rate of 8%. The conversion price was set at USD 0.25 per share. The funds will be used for product development, patent applications and working capital.

In addition, the team constellation at BioNxt Solutions is changing: Hugh Rogers has been appointed CEO and Wolfgang Probst CFO. Rogers is an entrepreneur and lawyer with extensive start-up experience. He most recently advised companies in the life sciences and commodities sectors on IPOs and restructurings. Rogers holds a degree in cell biology and genetics as well as a law degree and is a member of the British Columbia Bar. Probst is an experienced management consultant focused on investment advisory and capital raising. He has particular expertise in mergers, acquisitions, and corporate reorganizations and has successfully guided several start-ups.

BioNTech expands into China through M&A: New cancer therapies in development

The Mainz-based vaccine maker BioNTech takes over the Chinese biotechnology company Biotheus for USD 800 million. Another USD 150 million may be added if certain development goals are met.

The acquisition is also well financed: BioNTech has reserves of USD 18.7 billion and generated USD 1.26 billion in revenue in the third quarter of 2024. Profit was USD 208.4 million. The Company expects to generate at least USD 2.63 billion in revenue for the full year.

A new cancer drug called BNT327/PM8002 is particularly promising. This specialized antibody can simultaneously recognize and attack two different structures on cancer cells. In tests with over 700 patients, the drug has shown promising results. Further research is now to be further investigated for lung cancer and aggressive breast cancer.

The acquisition also gives BioNTech a significant advantage in China: the Mainz-based company has not only secured the global rights to the promising cancer drug BNT327/PM8002 but has also significantly expanded its research and production capacities in China. The existing team of more than 300 Biotheus employees with extensive expertise in research, development and production will be integrated into the BioNTech organization. Particularly valuable is the existing modern research and development center and the state-of-the-art biologics manufacturing facility, which BioNTech will use for its global manufacturing and supply in the future. The transaction is expected to close in the first quarter of 2025.

Despite the positive developments, the investment bank Leerink Partners has significantly lowered its earnings expectations for BioNTech. Analyst D. Graybosch now forecasts a loss of USD 3.79 per share for 2024, compared to the previously expected loss of USD 1.84. The reasons given are the high investments in research and development and the declining COVID-19 vaccine sales.

Bayer is making targeted investments in the Japanese heart medication market, which is expected to grow to USD 7 billion by 2029. The acquisition of the Aficamten rights for up to EUR 560 million demonstrates the Company's financial strength. The focus on the Japanese population with its comprehensive insurance system promises good growth opportunities. This strategy promises stable earnings in the medium term. The Canadian company BioNxt Solutions is developing a promising alternative for patients with swallowing difficulties in the form of a sublingual MS therapy. Strong patent protection in key markets is a strategic advantage. The first round of financing of USD 425,000 is comparatively modest compared to the other two companies presented, but it shows that the company is cost-conscious and taking a step-by-step approach. The new management also brings valuable start-up and life science expertise. For BioNTech, the USD 800 million acquisition of Biotheus is strategically sound: BioNTech not only receives the worldwide rights to the cancer drug BNT327/PM8002 but also modern research and production facilities in China, as well as 300 qualified employees. The solid financial position with EUR 17.8 billion in reserves enables this expansion. The losses expected by analysts for 2024 are factored into this and are justified by the high investments in research and development. The combination of a promising cancer drug, modern infrastructure, and qualified personnel in China appears to offer the greatest growth potential.