BioNTech SE (BNTX)

I would like to highlight something most of you have not been aware of so far. The strenght of the US dollar will lead to an increase of BioNTech's balance sheet. In the annual report it's noted under the headline "other operating income and taxes" (compare to page 78 of the annual report 2021).This position increased last year to Euro 504 mln during the financial year. The increase is mainly attributable to foreign currency differences from the measurement of operating balance sheet items. The increase reflects the change in foreign exchange rates and relates to the US dollar demoninated trade receivables which are mainly incured under BioNTech's COVID 19 collaboration with Pfizer, US dollar denominated trade payables as well as US dollar denominated other financial liabilities which mainly relate to obligations incurred from their license agreements.

Long story short BioNTech will benefit from the forex risk factor since they get paid by their collaboration partner Pfizer in US dollar. We will see an increase from last year's position at Euro 446 mln to this year as the US dollar average exchange rate raised from 1 US dollar- 0.85 Euro (2021) to 1 US dollar- 0.94 Euro.

One more thing from Morningstar - Their assumptions

We're maintaining our fair value estimate at $205 per ADR. We assume that BioNTech will book COVID19 vaccine revenue, largely from its Pfizer gross profit share, of EUR 15.7 billion in 2022, followed by a
step-down in sales in 2023 to EUR 9 billion and EUR 2.5-3 billion annually beginning in 2024, to account
for continued COVID-19 vaccinations in vulnerable populations (mostly elderly, but also high-risk
individuals).

From the wire services this Am

Pfizer Inc. and partner BioNTech SE have asked the U.S. Food and Drug Administration to approve the use of its Omicron-specific Covid-19 vaccine booster shot for children.

The regulator granted this version of the vaccine an Emergency Use Authorization for use in people 12 or older on Aug. 31.

The companies said Monday that they have submitted an application for emergency use authorization of the 10-ug booster dose for children ages five to 11.

An application to approve the booster for children in Europe would be submitted to the European Medicines Agency in the next few days, the companies said.

Pfizer and BioNTech have launched a Phase 1/2/3 study to evaluate the safety of the shot for children as young as 6 months old, following the same regulatory guidance as trials of their original Covid-19 vaccine.

FYI, PulseToday: "Novavax Covid jab should not be co-administered with flu jab." UKHSA has said that ‘the clinical significance of this is unclear’ but has said that the Novavax Covid-19 vaccine should be given at least seven days apart from the influenza vaccine. The guidance also refers to a UK study of co-administration of AstraZeneca and Pfizer BioNTech Covid-19 vaccines with inactivated influenza vaccines, which did not have the same results. When these vaccines were administered at the same time as the influenza vaccine, the study found ‘ACCEPTABLE immunogenicity and reactogenicity’.
We are beginning to see real world advantage of using non-protein vaccines. GL all.

Some U.S. pharmacies and other vaccine providers are offering the new Covid-19 booster shot only from Pfizer Inc. and BioNTech SE, after a manufacturing-quality problem at a contract manufacturer caused a shortage of Moderna Inc.'s new booster shot.

In recent days, federal officials have advised state officials there is a limited supply of Moderna's updated booster shots, said Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials.

A Moderna spokesman said the company anticipates resolving constraint issues in the coming days. "We are working closely with the U.S. government to deliver significant amounts of updated, bivalent booster doses as we continue to see high demand in certain areas of the country, " the spokesman said.

Some pharmacies and other vaccine sites have either canceled appointments or stopped scheduling new appointments for people seeking to get a Moderna booster shot. At CVS Health Corp., some pharmacies have used up all of their Moderna booster shots and continue to offer the Pfizer shot as they work to acquire more Moderna doses, a CVS spokeswoman said.

California-based health system Kaiser Permanente is urging people to get the Pfizer boosters if they would rather not wait for new supplies of Moderna's shot, a spokesman said. The Lehigh Valley Health Network in Pennsylvania has stopped booking appointments for the Moderna booster as it awaits more doses, and is offering the Pfizer vaccine, a spokesman said.

This was in my Inbox this morning Bofa updated comments on Various Bio Tech Names

Not much new on BNTX, other than discussing timing of shingles and Herpes vaccines - some positive timing developments (see - below)

and booster deliveries -

BNTX: BA.4/.5 booster rollout started in US
BioNTech (BNTX, Neutral, $242 PO) is a commercial-stage biotech company that
successfully developed Comirnaty, an mRNA-based COVID vaccine, while also advancing
a pipeline portfolio in other infectious diseases and oncology indications. The company
recently announced shipping of the updated BA.4/5 adapted bivalent booster has begun
in the US and they anticipate shipping in the EU will start soon. For the remainder of the
year, the company plans to initiate trials for mRNA-based vaccines for herpes simplex
virus type 2 (HSV-2), shingles, as well as malaria and tuberculosis in 2022/early 2023.
We note that an update from the phase 2 trial of BNT122 in combination with
pembrolizumab in first-line metastatic melanoma is now expected in 1H23 (prev. 2H).
We remain focused on booster uptake and delivery of the ~2.5bn signed doses in 2022.
Management reiterated its FY22 revenue guidance of EUR 13-17bn, and we expect the
guidance will be tighten when 3Q results are announced. We maintain our Neutral rating
with $242 PO.

Last Week Morning Star put out a buy recommendation PT 205
I will need two posts but this is excerpted from report on the pipeline
BioNTech has a very full but early pipeline, with more than 15 clinical stage oncology drug candidates. Personalized and off-the-shelf cancer vaccines are the company's key focus, but the pipeline also has other cancer therapies and infectious disease vaccines. BioNTech's technology platforms have won votes of confidence from several large biopharma companies, resulting in partnerships with Roche, Bayer, Eli Lilly, Pfizer, Sanofi, and Genmab. Beyond COVID-19, we see several oncology mRNA candidates forming the core of the company's portfolio, including off-the-shelf products BNT111 (advanced melanoma), BNT112 (prostate cancer), BNT113 (HPV-positive head and neck cancers), BNT115 (ovarian cancer), and BNT116 (lung cancer). Of these, BNT111 and BNT113 lead the way, as phase 2 studies started in mid-2021 after promising early results. These mRNA-based therapies were produced with BioNTech's FixVac technology, which produces off-the-shelf mRNA therapies based on shared antigens, in contrast to the iNeST platform, which produces personalized therapies based on a patient's individual neoantigens. The company's lead iNeST candidate is RO7198457 (or BNT122), which is partnered with Roche and had initial promising data in pancreatic cancer in combination with Roche's Tecentriq (melanoma data is expected in 2023). BioNTech is also using its mRNA technology to encode cytokines (ribocytokine programs BNT 151/BNT 152/BNT 153 are in phase 1 in solid tumors) and antibodies (BioNTech's first RiboMAb program, BNT141, entered phase 1 in December 2021). While the field is in the very early stages, we believe the development of individualized cancer immunotherapies is a moatworthy business, if successful in the clinic. The personalized nature of the medicine should result in unmatched efficacy and command strong pricing power in the market. Despite higher costs to manufacture personalized medicine, we expect personalized cancer vaccines to be high margin products as the business scales. Further, we expect this business will be difficult for competitors to replicate. The process leans heavily on bioinformatics, as researchers use proprietary programs to analyze a patient's DNA, identify the patient's unique mutations caused by the cancer, and determine which genetic instructions would produce an immune response sufficient to effectively attack the cancer cells. Then, researchers can engineer mRNA that encodes those unique mutations, producing that patient's personalized cancer vaccine. BioNTech's turnaround from start to delivery is roughly six weeks, and the company has a goal of reaching less than four weeks. BioNTech's competitor Moderna is also developing personalized mRNA cancer vaccines and has similar production goals. Both BioNTech and Moderna have spent roughly a decade honing their understanding of mRNA therapies, with drug candidates only recently entering clinical trials. Most of the company's assets are internally developed, but BioNTech has also added to its portfolio with a couple of opportunistic acquisitions from struggling biotechs. BioNTech acquired MabVax's assets and labs in May 2019, adding BNT321, a targeted antibody in phase 1 for pancreatic cancer, which is extremely aggressive and deadly, with just a 7% five-year survival rate. In addition to establishing a U.S. research hub, this deal also brought in an antibody discovery platform, supplementing the company's already-established RNA platforms. Then, BioNTech's early 2020 acquisition of struggling biotech Neon Therapeutics for $67 million brought in cell therapy BNT 221, complementing BioNTech's in-house CAR T cell program BNT 211 (both in phase 1). A partnership with Genmab has also brought three bispecific antibody programs to phase 1. The expansion into drug classes outside of mRNA is interesting: While BioNTech is venturing outside its established area of expertise, it's also gaining talent in new areas and possibly boosting its long-term growth potential. We like the long-term potential for innovation and combinations between drug classes, such as using CAR-T cell therapy in combination with mRNA therapy (CARVac) with BNT211 in solid tumors