BioNTech SE (NASDAQ:BNTX) Q3 2023 Earnings Call Transcript

Ryan Richardson: Yeah, thank you, Chris. Maybe I’ll take the iNest question first and then turn it over to Ugur and Ozlem for the flu-COVID. So on BNT122, actually on our last earnings call, we provided revised guidance that we did not expect data this year. As you remember, the trial is randomized and has a PFS threshold to trigger the PFS analysis, which we had not been met and which we didn’t anticipate would be met this year. We do plan to provide a trial update this year, but we’re not expecting data this year.

Ugur Sahin: And the second question was related to the?

Ozlem Tureci: To the comparator to the flu combo vaccine. If I got that right.

Ugur Sahin: Yes. So we are comparing both. We are comparing flu mRNA, COVID mRNA as comparator as well as established flu vaccines that are based on proteins or inactivated flu vaccines. Both comparisons will be in the study.

Chris Shibutani: And that’s what the FDA will be evaluating in the Phase 3.

Ugur Sahin: At least in our case.

Operator: Thank you. We’ll now move to our next question. This is from the line of Akash Tewari from Jefferies. Please go ahead.

Unidentified Analyst: Hi, this is Amy on Akash. Thanks so much for taking our question. So just two from us. Number one, we’ve seen Pfizer reduce costs in the face of reducing COVID vaccine demand while at the same time we’re seeing Moderna increase costs. When you think about buy on tax plan spend over the next three to four years, how willing are you to eat into the cash generated during COVID? Should we expect it to decline on an annual basis or will the team aim to sustain R&D solely off of residual vaccine demand? And then number two on the COVID flu program, given the economics between you and Pfizer are 50% right now and may drop to potentially in the 30% range, if this program does become a success for BioNTech, do you anticipate it being net positive, net negative or great even for BioNTech’s cash generation? How should we think about the increased demand potentially being offset by lower economics? Thanks so much.

Ryan Richardson: Amy, can you just clarify the second question you asked? Was that in reference to a combination vaccine?

Unidentified Analyst: Yes, yes, the COVID flu combo vaccine.

Ryan Richardson: Okay. So I’ll take the first one and maybe Jens can chime in. Yes, so we see that — we’re in the midst of a transition period right now. Our COVID vaccine franchise is transitioning from pandemic to endemic market. This is of course happening this year, but we also expect that transition to continue next year. And we’re also transitioning to become a commercial stage oncology company. We’ve outlined some of the programs that we think are going to drive that transition. As we go through this transition, we think it’s an immense asset to the company to have a strong balance sheet. And we’re very happy with our ability this year if we meet revenue guidance to maintain profitability. That’s an important point for us. As we go into the next couple of years through this transition, we expect to continue to maintain a very strong balance sheet, and that’s going to continue to be a priority for us.

Jens Holstein: Yeah, Ryan [indiscernible] very nicely. It’s not much to add. I mean, going forward, of course, with the collaboration, we first and foremost got to invest in these combination trials currently. Flu COVID, flu COVID RSV, those settings will eat up some cash, but we’re very positive in terms of our expectations on the profitability share that we will get out of the collaborations and those combinations. In our view, this will create new markets and will secure, of course, the existing part and business that we have for COVID. So we think economically that should be something of great value for the company going forward.

Ryan Richardson: And to your question on the combination vaccines, we haven’t yet disclosed the full economics with Pfizer on combination vaccines. We plan to do that in the near future. We have communicated today that we intend with Pfizer to embark on a pivotal trial, Phase 3 trials with those combination vaccines. And we do think that there is substantial potential for combination vaccines if successful to improve uptake of our COVID vaccine based on the rates that we’re seeing now in terms of uptake. There’s a large difference between, for example, where flu vaccines are in terms of uptake versus what we’re expecting this year for COVID. So we do think the combination vaccines can play an important role in terms of offering convenience and added benefit to increase the franchise over time. And we think that from a timeline perspective, if successful that those vaccines could be, start to have an impact for us from 2025 onwards.

Operator: Thank you. We’ll now move to our next question. Please stand by. This is from the line of Yaron Werber from TD Cowan. Please go ahead.

Yaron Werber: Great. Thanks for taking my question. I have a couple. Just on 1046, the PDL combo, you mentioned moving to a second line endometrial study in combination with Pembro. Just any update and I’m not trying to front run to more, just any update on the checkpoint experience, non-small cell lung cancer cohort, and is that still sort of in the cards? And then secondly, for 323, BNT323, on the HER2 low side, how do you define HER2 low? Is it histology? Do they have to have any expression at all? And why do you think you’re confirming activity in a population that sort of failed [indiscernible] before? Thank you.

Ugur Sahin: Yes, to your first question, 1046, yes, the lung cancer cohorts are continuing and we will most likely report data on this cohort in the next year, mid next year, and it’s still a target for follow up.

Ozlem Tureci: Target of interest.

Ugur Sahin: Target of interest in lung cancer. For BNT323, yes, HER2 low is defined as staining, which is [Technical Difficulty] two plus without any amplification. And activity of this ADC compound in this patient population, which is clearly better than Trastuzumab alone, is based on the highly potent ADC activity and on the bystander activity, allowing not only to remove antigen-positive tumor cells, but also the tumor cells in the surrounding which are negative.

Operator: Thank you. We’ll now move to our next question. This is from the line of Jessica Fye from JP Morgan. Please go ahead.

Jessica Fye: Hey, good morning. Thanks for taking the question. Can you outline what key pipeline updates we should expect between now and year end? You mentioned an update on the iNest melanoma trial. What else should we be looking forward to, whether from the 4-1BB programs or otherwise? And then related to iNest with the new trial starting in adjuvant pancreatic cancer, can you talk about what drove that decision and was it based on something you’re seeing? And then Lastly, just a financial question. You lowered OpEx guidance again this quarter, but also suggested that from here, R&D will likely grow to support these pipeline investments. What about SG&A? That guidance didn’t change as much. Is there less flexibility in that line if expenses need to be cut again. Thank you.