BioNTech SE at Jefferies Healthcare Conference (Virtual) Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Great, great. I guess now focusing on your COVID-19 vaccine efforts, I guess, one of the more meaningful upcoming data releases is your booster data. Can you provide an overview of your booster strategy? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 01, 2021 / 3:00PM, BNTX.OQ - BioNTech SE at Jefferies Healthcare Conference (Virtual)

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it. I got it. So data late Q2, early Q3. I guess, in respect to that data, what are you hoping to see there? What are your expectations around safety and tolerability? And I guess, you're neutralizing antibody titers. How are you thinking about that, what are you hoping to see? And how will you make the decision whether to go forward with the wild type version versus the 351 South Africa variant version?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it. So on the neutralizing antibody front, you are hoping to see levels that exceed levels of antibodies that you had after the second or after that second booster dose?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : At or above. Okay, that's good. Thank you for that. And I guess while we are discussing this particular topic, is there the possibility of a multivalent vaccine, so a vaccine that contains, not only the wild type version, but also a South Africa version of the spike protein in one shot? Is that a possibility?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it. So you're not in the clinic --?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it. Okay. That's extremely helpful. Thank you there. And I guess I'm sure you're in constant dialogue with the various health authorities on if and when booster shots are needed. I guess internally, what data points are you looking at to determine whether or not, and when booster shots are needed? Is it once antibody levels cross a certain threshold? Is it viral breakthrough with mild or severe symptoms? Any color there would be extremely helpful.

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it. So is there a certain threshold that you believe that once you cross that level, once a patient crosses that level, that their protection is significantly reduced? So protection against -- the prevention of symptoms in severe disease? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 01, 2021 / 3:00PM, BNTX.OQ - BioNTech SE at Jefferies Healthcare Conference (Virtual)

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it.

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it, okay. That's helpful. Okay, now switching gears to the advance purchase agreement. Now, you previously mentioned that you expect additional orders for 2021 will come in. Is that still the case? You currently have 1.8 billion doses contracted. Are you still expecting more over the course of 2021?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Okay, got it. So that's for booster doses. But I guess for the primary series, do you expect to deliver additional orders this year?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, okay, okay. That's good to know. And I guess around the 2022 APAs and 2023, at this point, do you anticipate delivering the same level or the same volume of doses in 2022 as you did in 2021 or halves of that since the majority will be boosting? Any color around that would be extremely helpful.

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it. So it's safe to assume that from a volume perspective, 2022, you will likely be delivering more doses versus this year. Is that a safe assumption?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it. Okay. And I guess, what are your current thoughts around pricing for 2022 and 2023? Clearly, there is high demand for your product. Are you looking to give a discount on pricing or is pricing, more or less, going to stay stable from next year as it is this year?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it. So in respect to that, so when you're looking at 2023, 2024, in even, let's say a private individual paying market, you're looking at a scenario where the price of the vaccine could be higher than what it is currently. Is that as a safe read?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it. Okay. And I guess my next series of questions, before we leave your vaccine efforts, you have a flu vaccine that's entering the clinic in Q3. Can you speak to this program in where you think your clinical candidate for flu could be differentiated versus current standard of care?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, okay, that's helpful. And just related to that program before we leave it, are you expecting to run a ---- is Pfizer expecting to run an entire Phase 3 efficacy study or would neutralizing antibody titers be enough for that particular program?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, okay. That's extremely helpful. And lastly, is a combination product, a combination COVID flu vaccine something that's also in the works for Pfizer, BioNTech?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Got it, got it, okay. Moving to your oncology efforts, you recently disclosed preliminary data for your next-generation CAR T BNT211. Can you review -- first, provide an overview of that particular product, clinical candidate, the review of the data, and what are your expectations or when can we see more data for this particular program?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Interesting, interesting. And we look forward to that data. I guess next, you have a number of -- BioNTech has a number of antibodies that are in development: BNT311 as well as BNT312. Can you provide an overview of these programs and your expectations around the next data update?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Absolutely, great. Thank you. I have a question that came in from an investor, just wanted to ask you this one. What is the timeline to complete the rolling BLA submission? And do you anticipate a truncated review period for the full approval in the US since you already have an EUA?

Question: Kelechi Chikere - Jefferies,LLC - Analyst : Late Q2, Q3. Got it, got it. All right, that's extremely helpful. All right, I think we are out of time here. Thank you, Ryan, very much. This has been great and extremely insightful. Best of luck and we look forward to continued progress and data updates over the next few months. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 01, 2021 / 3:00PM, BNTX.OQ - BioNTech SE at Jefferies Healthcare Conference (Virtual)