DBV Technologies SA at Goldman Sachs Global Healthcare Conference Transcript

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

Question: Graig Suvannavejh - Goldman Sachs - Analyst : So with that, Daniel, you are new to the company, CEO. Maybe if you could just tell us your thought process when you were thinking about opportunities, why DBV was the one that you were compelled to join.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : And for the investors who may not know your background, and as you were excited about launching a commercial product, maybe if you could give investors some background as to your prior experience launching products or commercializing products. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2019 / 3:40PM, DBV.PA - DBV Technologies SA at Goldman Sachs Global Healthcare Conference

Question: Graig Suvannavejh - Goldman Sachs - Analyst : So, you talk about being drawn to fascinating science and this is a Company with a platform technology that's very unique. Can you tell us more about Viaskin?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Okay, well, maybe will put on pause our discussions around opportunities in applications for the technology beyond Viaskin Peanut. And maybe let's just focus right now on Viaskin Peanut. And I think for many investors this is the main valuation driver of the Company, the main focus of the Company right now. So, obviously we all know about peanut allergies. But why is it important in your mind to have an FDA approved treatment for peanut allergies?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : It does, it does. I think --- so obviously with a large patient population in the US, over 1 million kids with peanut allergies, how should we think about that commercial opportunity?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Is there a way and is the Company ready to talk about kind of quantifying what that could look like? Obviously there is a large patient segment out there, it's a market that hasn't been built before.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : And just for those who might be interested for the first time in trying to understand, yes, I understand there's 1 million kids, but how tractable is this market?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : So I think ---.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : It is. And I think for everyone who knows the story well enough -- obviously we're going to shift to where the product stands right now. And you had some news at the end of last year and certainly there's ---.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : To the day, exactly. There's a remediation process that's ongoing. So what can you share about where the Company is right now and how that process is going?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : If we can maybe go back to the comments that you got from the FDA. And you said there were 17 individual items that they wanted some further information about. How can we bucket kind of what those requests were? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2019 / 3:40PM, DBV.PA - DBV Technologies SA at Goldman Sachs Global Healthcare Conference

Question: Graig Suvannavejh - Goldman Sachs - Analyst : And I think it's important to revisit the fact that the FDA focused specifically on manufacturing, but they (inaudible) confirm that there were no clinical or safety or issues.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Maybe we can talk about the efficacy profile of the product. And you did run a pivotal Phase 3 study. Can you just remind the audience what the high-level findings of that study were?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Okay. Now when the Phase 3 data were announced there was a little bit of controversy around that data set. And I believe it had to do with meeting a prespecified lower bound of the confidence interval. And I know you get into statistical technicalities, but can you maybe for the audience, from a high-level perspective, kind of recap what the debate was there?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Can you perhaps --- you mentioned that there is some FDA precedence for approving allergy products that have either missed a certain technical bar or have been approved under circumstances where you might suggest that they may not get approved, but ended up getting approved anyway. Are there specific examples of those products?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : I think a lot of the investor debate beyond just the remediation of the BLA fast forwarding maybe 12 to 15 months has to do with the competitive dynamic. And certainly there is another company that is also filing for approval. And I think it would be important for us to kind of discuss kind of a compare and contrast Viaskin Peanut with your competitor.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : And the other product is an oral type of immunotherapy.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : You obviously with Viaskin Peanut have something that's more of an epicutaneous. Maybe talk about how with an oral immunotherapy, which I believe is used currently, how that might present challenges or what are the pluses and minuses of such an approach?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : So, as you are a company that's kind of on the cusp of a potential regulatory approval, commercialization is next up. And I assume the Company is, as it's focused on remediating the BLA, is also getting ready for commercialization.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : So what are the types of things that you have been doing, that you are doing, that you still need to do to feel fully ready to commercially launch this product?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : So I think this is the type of market where I think the payers will be important. And what kind of feedback have you gotten, if you have, from payers in terms of what they're looking for? And then maybe a follow-up to that is a question around your current thoughts around potential pricing of the product.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : And maybe in terms of the actual commercialization effort, so size of the organization that you need to build out, how should investors think about kind of what that looks like?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Yes, it does. I think as we think about the US, which my assumption will be the primary initial market for Viaskin Peanut, there's obviously peanut allergies outside the US. So can you give us an update how you're thinking about the ex-US strategy, timelines, what that commercial sales force might look like, those things?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : And the timelines on when you might be able to articulate what the ex-US strategy is going to look like, how ---?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : I would say while most of the focus has been on Viaskin Peanut, you alluded to the fact that there are other programs. Maybe in the few minutes that we have left, if you can just talk about how you're thinking strategically about that pipeline given that there's focus right now on Viaskin Peanut.

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Okay. And as I ask many companies that are in the business of trying to launch product, get a product approved, there's always financing, cash. Can you just remind the audience where we are, how you're thinking about the future financing of the Company?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Okay, and maybe my last question is just as we look at the next 6 to 12, 18 months, what can investors look forward to coming out of DBV?

Question: Graig Suvannavejh - Goldman Sachs - Analyst : Okay, great. Well, thank you very much, Daniel. Appreciate it.