BioNTech, BioNxt Solutions, Bayer - The big one is only a matter of time

BioNTech - Strategic collaboration with DualityBio

Last week, all eyes were on BioNTech's annual figures. In Q4, the Company achieved total sales of EUR 4,278 million, compared to EUR 5,532 million in the same period last year. For the 2022 financial year, total sales amounted to EUR 17,311 million, compared to EUR 18,977 million in the same period last year. Net profit was EUR 2,279 million in Q4 and EUR 9,434 million for the full financial year. In the same period last year, the net profit was EUR 10,292 million.

What stands out is the significant increase in research and development (R&D) costs, which almost doubled compared to the same quarter last year. But the times of big sales and exorbitant profits are over for now. BioNTech expects revenues of around EUR 5 billion for 2023, with EUR 2.5 billion budgeted for R&D. In the end, the net profit should be around EUR 900 million. On 3 April, the biotech company secured exclusive global licences for two potential cancer drugs from the Chinese biotech company DualityBio.

The treatments target different structures found in various human cancers and will complement BioNTech's clinical oncology pipeline. The agreement includes upfront payments of USD 170 million to DualityBio, potential milestone and royalty payments of over USD 1.5 billion, and royalties on future product sales. The profits will be invested in the Company's future, which is looking to make its next big splash, particularly in oncology. The announcement boosted the share, but the downward trend would only be broken with closing prices above EUR 125.50. Currently, one share costs EUR 118.90.

BioNxt Solutions - Rotigotine patch ahead of clinical trial

BioNxt Solutions Inc. is a biotech company that drives the development of innovative drug formulations, diagnostic tests and active pharmaceutical ingredients. The goal is to provide cost-effective solutions to improve efficacy and safety. Solutions include the development of precise and effective drug delivery systems, rapid tests for the detection of infectious diseases and oral health, and novel compounds for neurological applications. In February, the Company released news on its rotigotine transdermal patch for treating Parkinson's disease. Following promising in vitro and ex vivo results, the Company plans a pilot human clinical trial in the second quarter of 2023.

In early March, an agreement was signed for a clinical trial for the treatment of Parkinson's disease with a rotigotine transdermal patch. The study aims to evaluate the bioavailability and skin tolerability of the new formulation compared to the branded product. BioNxt has also started manufacturing clinical samples for the study and plans to develop in-house capabilities for commercial manufacturing in the future. The global transdermal skin patch market was valued at nearly USD 6.5 billion in 2020 and is expected to grow to around USD 20 billion by 2028, according to estimates from Kuick Research, Pharmaceutical and Healthcare.

On 7 March, the Company signed a final agreement to acquire a novel technology for the coating and delivery of precision medicines. The Company is thus expanding its drug delivery expertise and aims to achieve more precise drug release and more predictable dosing of active ingredients in the oral dosage form. The transfer and assignment of the technology will be made in exchange for a net revenue share of 6%, but this can drop to 3% if a lump sum of USD 2.5 million is paid. The first tranche of the private placement was closed at the end of March, raising a good CAD 2 million. The shares were placed at CAD 0.50. In addition, there was a half warrant at CAD 0.75 per share. This explains the pressure on the share, which is still quoted at CAD 0.68.

Bayer - Wants to take off in the US

While Bayer is still facing problems in the Crop Science sector due to the Monsanto takeover, things are looking much better in the pharmaceutical sector. On 2 March, the Company announced that the global clinical development programme for the already approved drug darolutamide for prostate cancer would be expanded. The new phase III trial, ARASTEP, will investigate the efficacy of the oral androgen receptor inhibitor darolutamide plus androgen deprivation therapy.

The Leverkusen-based company plans to invest USD 1 billion in the research and development of new drugs in the US this year. The goal is to double the Company's sales there by 2030. To this end, drugs developed in-house are to be marketed independently in future instead of relying on partnerships with US companies. In preparation for this step, Bayer has increased its marketing team by about 50% in recent years and intends to expand it further.

In the future, more than 50% of all blockbuster candidates, which account for more than half of the top sales potential, are to come from the US. The group was also successful in its legal dispute with Merck & Co. The US group wanted to pass on the liability risks in connection with the asbestos-contaminated talcum powder to Bayer but failed for the time being. The Bayer share has formed strong support around the EUR 55 mark and is currently trading at EUR 59.12. Since the announcement of the financial figures for 2022, there have been 7 buy recommendations with price targets between EUR 70 and EUR 100.

In order to cope with the diseases of humanity, the willingness of the biotech and pharmaceutical industry to invest is an important factor. BioNTech has an extensive pipeline in oncology and has acquired global licences for potential cancer drugs from DualityBio. BioNxt Solutions starts a clinical trial with a rotigotine transdermal patch to treat Parkinson's disease. Bayer expands its darolutamide development programme and plans to gain a foothold in the US.