Dbv Technologies SA (DBVT) 2021 Q4 法說會逐字稿

Welcome to the DBV Full Year 2021 Financial Results. My name is Adrienne, and I'll be your operator for today's call. (Operator Instructions) Please note this conference is being recorded. I'll now turn the call over to you Anne Pollak. Anne, you may begin.

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31, 2021. This release is available on the Press Release section of the DBV Technologies website.

Before we begin, please note that today's call may include a number of forward-looking statements, including, but not limited to, comments regarding our clinical and regulatory development plans, the timing and results of interactions with regulatory agencies, our forecast of our cash runway, and the ability of any of our product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause the company's actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements.

Please refer to the company's filings with the SEC and the French AMF for information concerning risk factors that could cause the company's actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, the company disclaims any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call.

Joining me on the call today are Daniel Tasse, Chief Executive Officer of DBV; Sebastien Robitaille, Chief Financial Officer; and Pharis Mohideen, Chief Medical Officer. Daniel will provide an update on Viaskin Peanut and our extended cash runway, and Sebastien will review the full year 2021 financial results. Pharis will join Sebastien and Daniel for questions at the end.

I will now pass the call over to Daniel.

Thank you, Anne, and thank you all for joining us on the call this afternoon. As Anne mentioned, this evening, I will provide an update on 2 key areas of focus for DBV. The first, the clinical and regulatory development of our modified Viaskin Peanut patch and the second, an update on our cash management and our cash runway.

Now let's start with Viaskin Peanut. During our last corporate update in December, DBV announced that we will initiate a pivotal Phase III clinical study for a modified Viaskin Peanut patch in children in the intended patient population. As we said then, we still believe now, this data from the pivotal trial will further strengthen the Viaskin Peanut label, if approved, and enhance its commercial potential. And as such, initiating this trial is our highest priority. Now we completed the pivotal trial protocol at the end of February, and prepared it for submission for the FDA -- to the FDA for their review.

Now in parallel to finalizing our proposed protocol, we also have had timely and productive exchanges with the FDA. We very much appreciate the FDA's willingness to engage with us during this critical stage of protocol alignment. So we believe that incorporating any feedback from those collaborative FDA discussions, on the broad strokes of the protocol, will facilitate and possibly streamline the protocol review process. We intend to submit the full protocol following that further alignment from ongoing and productive exchanges with the FDA.

And now turning to our cash management. Through our continued financial diligence, we have extended our cash runway from the third quarter this year into the first quarter of next year, so first quarter of 2023. Based on our assumptions, we believe our cash balance and significantly reduced monthly run rate, provide us with sufficient time to gain alignment with the FDA, as I referred to earlier on, and gaining alignment on final pivotal protocol for Viaskin Peanut. Now as you know, in biotech, there's a balancing act. Extending cash runway is always a delicate balance between cutting expenses now and obviously, our ability to preserve critical research and development, which fuels enterprise value and growth later.

I assume you want to commend DBV employees, who collectively aim to do more with less, and preserve their ability to thoughtfully advance our Viaskin platform in the coming year. And I'm looking forward to updating you obviously on our progress.

And at this point, let me turn the call over to Sebastien for a review of our full year 2021 results. Seb?

Thank you, Daniel. Earlier today, we issued a press release with our 2021 financial results. Cash and cash equivalents as of December 31, 2021, were $77.3 million, which, as Daniel stated earlier, we believe will support our operations into the first quarter of 2023. When we initiated our global restructuring initiative in June 2020, we aimed to reduce our average monthly cash burn by 40% to 50% in the second half of 2021 as compared to the first half of 2020. I'm very pleased to report that we exceeded our goal. Cash used in operating activities in the second half of 2021 was $41.7 million, which represents a 54% decrease compared to the first half of 2020. We continue to maximize the efficiency of our spend and remain highly disciplined in our cash management.

And now I will turn the call back to Daniel for some closing remarks.

Thanks, Sebastien. So again, I'm very pleased by the progress we've made since [we last talk] in late December when we announced our decision to now initiate a pivotal trial for the modified Viaskin Peanut patch. Most importantly, since then, we have engaged the FDA on key elements of the Viaskin Peanut dose in preparation, the new protocol submission. The protocol is ready to go. And we are very pleased with the exchanges we're having with the FDA.

Obviously, finalizing the proposed pivotal trial protocol and preparing for FDA submission was our top priority. And I want to thank Pharis and his entire team for their hard work and for the position we're in right now. I would like to also recognize the extensive review of our planned expenditures and financial discipline has been practiced by all DBV employees, led nicely by Sebastien and his team. DBV employees continue to demonstrate the creativity, the discipline, the resilience that is needed to realize the full potential of Viaskin technology for patients, for families and for allergists and treating physicians.

Now I would like to tackle 1 last topic before we open the line for questions. It is no secret that DBV will need to raise money, before we submit the modified Viaskin Peanut BLA. The good news is that, based on our current assumptions we just shared with you, we have sufficient time to gain [alignment with] FDA on the protocol for the pivotal mVP trial.

Now our current stock price, in our opinion, does not reflect the significant potential of the Viaskin platform, the Viaskin Peanut specifically. As such, exploring a number of tools to finance the company including non-dilutive financing strategies that could leverage Viaskin Peanut's significant commercial potential, amongst all other options that are worth contemplating. A mix of financing tools done incrementally amongst the potential options that we are exploring.

Now I want to thank everyone on the phone today and a webcast for joining us. And operator, at this time, we would like to open the line for questions.

(Operator Instructions) And our first question comes from Jon Wolleben from JMP Securities.

It sounds like, Daniel -- it sounds like you've already had some interactions with FDA on the protocol. So I was hoping you could provide a little more color on that back and forth in terms of what you're learning that they want to see in this protocol and kind of the cadence of those back and forth.

The cadence has been very good. What we discussed with the FDA right now is what I call the basic broad strokes and core principle of our study. As you know, Jonathan, we have a pretty unique patch that has no analogs and our ability to have this rich discussion with the agency on the key elements. In principle, before we send them the nitty-gritty of the details, we thought was the right approach. And the fact that the FDA is engaged in those discussions, obviously, it's heartwarming to us. I don't wish to provide more detail at this point in time, because, again, I would be providing half of that conversation with the FDA. I would wish us to be protective of that discussion here. But I can only tell you that the protocol is ready to go and the fact that we have not submitted it is something that we're pleased with, we're happy with because we're showing good progress in parallel.

Can you give us any sense of when this could be submitted and then kind of next steps between today and actually starting the study?

Yes. It will not be on time. The next (technical difficulty).

Daniel, you're breaking up. We're having a hard time hearing you.

Sorry, what about now?

That's got us better.

Yes. My apologies. First thing, Jonathan, we are ready to send the protocol. The interactions with the agency are taking place frequently. We would expect to be sending the protocol in short order. But again, we believe that getting to agreement on those core principles will make for a faster, more expeditious and better protocol at the end of the day, so the trade-off here is the 1 that we're very comfortable with.

Got it. Makes sense. And maybe 1 last 1 for me, if I may. Could you give an update on the epitope program?

Pharis, you want to take it?

Yes. So the epitope study, as we've said in the past, is due to report out mid-year, and we're looking forward and excited to see the results of that study.

And have you set any internal expectations on what you'd want to see to warrant moving forward in the younger 1-to-3-year old, or how should we think about a dual path forward with 2 different patches?

Well, that's it. If I may, Pharis, you can add more details. Epitope is done with the current patch. Obviously, the study in the intended population, the second pivotal we're discussing will be in the older children. We have a number of options on what we do with the data. As you understand, Jonathan, until we see the data (inaudible) informs how we move forward is difficult to forecast. And at this point in time, again, I'd rather not speculate. It's an important population, as you know, 1-to-3-year old besides per se, representing an epidemiology of about or prevalent about 300,000 kids. But more importantly, it's also very often the age of diagnosis and time also where the children are most vulnerable, obviously, given the young age. The ability for them to build strategies to avoid external peanut consumption is much more difficult for them. So it's a very important market for us.

We will have the data with CDP. And once we see it is on the path we can take, but I'd rather reserve judgment until we see the data. We are so excited as by the potential that this study could represent in adding options for children out there. Let's be clear, the 1-to-3-year old, nothing is approved for them right now.

(Operator Instructions) And currently, we have no further questions.

Operator, if we have any other questions? You can go 1 more time. We don't?

No more questions in the queue.

Okay. Again, I want to thank everyone for joining this afternoon or this evening for our colleagues in Europe. And as you know, we're always available for comment information. So I thank you all for your attendance today and wish you a great evening. Bye-bye.

Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.