BioNTech SE Q2 2020 Earnings Call Transcript

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

Question: Matthew Thomas Holt - JPMorgan Chase & Co, Research Division - Analyst : This is Matthew on for Cory. So I guess just wondering, for BNT162, if you can talk a little bit about how you maintain the integrity of a Phase III blinded trial if a large proportion of the BNT162 patients are expected to get fevers and other systemic AEs? And what your view is on whether this could impact the ultimate outcome of the trial.

Question: Matthew Thomas Holt - JPMorgan Chase & Co, Research Division - Analyst : Okay. Great. And then just wondering if you can walk us through your assumptions, or essentially what needs to happen for the Phase III program to get data and a potential regulatory filing in October. I'm just -- I guess, maybe if you can help quantify how dependent this is on either enrollment or infection rates. Or what might be the key factor in the timelines?

Question: Arlinda Anna Lee - Canaccord Genuity Corp., Research Division - Analyst : Congrats on all the progress. I had a couple of questions on 162. One, can you provide an update on the enrollment of the pivotal trial? And two, I heard that some of the net cost for the trials have already -- you've given guidance that, that was earlier in the development front. I'm wondering what you think the cost might be for the remainder of the year. And then also on your oncology pipeline. I mean, just more broadly, I guess the rapidity and efficiency with which you guys have taken 162 into the clinic, I think, highlights you guys -- your platform. And I'm wondering what your appetite might be for additional collaborations. And if you've been getting inbound interest.

Question: Arlinda Anna Lee - Canaccord Genuity Corp., Research Division - Analyst :

Question: Arlinda Anna Lee - Canaccord Genuity Corp., Research Division - Analyst : Great. And then I guess the third question was, basically, given you guys [1 or 2 kind of] the platform, I'm kind of curious about whether you've gotten inbound interest and what your appetite might be for additional strategic collaborations.

Question: Suzanne van Voorthuizen - Kempen & Co. N.V., Research Division - Analyst : I have a question on the COVID-19 vaccine. Looking back at the 4 different candidates that you went into Phase I with originally, I was just wondering, for b1 and b2, these are mod-RNAs? It is our understanding that this format is more often used by BioNTech to de-immunize mRNA to make it especially useful for immune-silent applications. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 11, 2020 / 12:00PM, BNTX.OQ - Q2 2020 BioNTech SE Earnings Call So can you elaborate a bit, are b1 and b2 also uridine modified? Or how are they modified to be more immunogenic?

Question: Suzanne van Voorthuizen - Kempen & Co. N.V., Research Division - Analyst : Got it. Got it. And then maybe on the Phase II/III trial. In terms of the primary endpoint, can you remind us of the bar that you have to achieve? Was that a 50% reduction in infection rates? Do you need to hit both co-primary endpoints or one of the 2 to claim success?

Question: Suzanne van Voorthuizen - Kempen & Co. N.V., Research Division - Analyst : And are the co-primary endpoints, are they either/or, or are they and that you need to achieve to claim success?

Question: Suzanne van Voorthuizen - Kempen & Co. N.V., Research Division - Analyst : Okay. And maybe just one follow-up in this regard. Just to clarify for the filing, is the primary endpoint data the hard requirement? Or maybe for emergency use authorization, will there be immunogenicity data analyzed with the interim analysis? Could it be that you can file on that if your primary endpoint data is trending in the right direction, for example? Or is it a hard requirement?