BioNTech, BioNxt Solutions, Bayer - Turn of the tide

BioNxt Solutions - Broadly diversified

One of these promising companies is the broadly diversified life sciences accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and the manufacture and evaluation of new active pharmaceutical ingredients. The Company, which has a market capitalization of EUR 36.88 million, conducts research and development activities in North America and Europe, with an operational focus in Germany.

Within the three business areas, significant successes have been celebrated in the recent past, with several projects about to enter commercialization. In the area of psilocybin research, the Canadians were able to file a patent application for their collection of novel psychedelic substances that can be targeted for the treatment of neuropsychiatric, neurodegenerative and neuroinflammatory disorders. These include depression, tobacco, opiate and cocaine addiction, and alcoholism. Globally, around 350 million people suffer from depression. This figure alone gives an idea of the enormous potential.

At the end of October, BioNxt reported positive in vivo results of a rotigotine patch for treating Parkinson's disease. Rotigotine is an active ingredient already approved in Europe and the US for the treatment of Parkinson's disease and restless legs syndrome. XPhyto compared an active ingredient patch currently on the market with the patch developed by its German subsidiary Vektor Pharma TF GmbH. Here, the results for the criteria "penetration of the skin" and "dissolution behaviour of the active ingredient" clearly exceeded the predictions. With the results available, the Company is now preparing for a pilot clinical study in humans, which is to be completed in the second quarter of 2023.

In parallel, BioNxt plans to build up appropriate capacity for commercial manufacturing at its German drug development facility. The clearest advantage of adding rotigotine via patches rather than oral administration is the improved efficacy of the dopamine agonist. As a patch, the bioavailability of the active ingredient can be increased to 24h with a simultaneous slow and steady release of rotigotine into the body. The market volume in Parkinson's disease has been estimated at USD 518 million for 2021, according to market research institute Wissen Market Research.

Bayer - Outlook below expectations

Fiscal 2022 ended with strong sales growth in the double-digit percentage range for the pharmaceutical and agricultural giant from Leverkusen. The main driver was the agricultural division and high prices for the controversial crop protection agent glyphosate. According to the report, Group sales grew by 15% to EUR 50.7 billion, while the operating result grew by more than 20% to EUR 13.5 billion. Net income even increased fourfold to EUR 4.15 billion. Due to the strong earnings growth, a dividend of EUR 2.40 per share was announced, an increase of EUR 0.40 compared to the previous year.

However, Bayer expects growth to slow in the current fiscal year. The reasons for this are, on the one hand, falling prices for the weed killer glyphosate and higher costs and price pressure for some medicines. Accordingly, the DAX-listed group is calculating sales of between EUR 51 billion and EUR 52 billion. Adjusted operating profit Ebitda is expected to reach EUR 12.5 to 13 billion on this basis. Free cash flow is expected to be EUR 3 billion, just below the EUR 3.1 billion achieved in 2022.

The analysts at Deutsche Bank Research continue to be positive, maintaining their "buy" rating on Bayer shares with a price target of EUR 79 following the announcement of the figures. The Company's fourth-quarter sales were in line with expectations, while adjusted operating profit was slightly higher than expected. The outlook for sales for the current fiscal year was also in line with forecasts, while the estimates for earnings per share had to be adjusted downwards.

BioNTech - Critical mark

Corona is disappearing increasingly from our society, and the willingness to vaccinate is drastically decreasing, as well as the share prices of vaccine manufacturers. The share of the German flagship BioNTech lost about a quarter of its stock market value since the beginning of the year and is trading at EUR 130.27, close to the high from 2020. If this support is broken, the next short-term target will be EUR 117.

Together with US partner Pfizer, the Mainz-based company has submitted an application to the US Food and Drug Administration (FDA) for full approval of its Omicron-adapted COVID-19 vaccine. The companies are seeking approval for the updated vaccine as both a primary and booster vaccine for individuals 12 years of age and older. FDA advisors had voted unanimously in January to use the same coronavirus strain for both the primary and booster doses of the COVID-19 vaccine to simplify the vaccination schedule in the United States.

If the request is approved, individuals will be able to receive the updated vaccine as the first dose, rather than using the original vaccine for the first doses, before having access to the updated version for the booster shots, the Company said.

The Corona pandemic continues to ebb, and a final easing should begin no later than spring, which is likely to weigh heavily on vaccine maker BioNTech's sales figures. Bayer disappointed with its outlook for 2023, while BioNxt reported positive developments in all business areas.