Dbv Technologies SA (DBVT) 2022 Q4 法說會逐字稿

Good day, and welcome to the DBV Technologies Full Year 2022 Financial Results Conference Call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 DBV Technologies 2022 年全年財務業績電話會議。 （操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Ms. Anne Pollak, Head of Investor Relations. Please go ahead.

現在我想將會議交給投資者關係主管 Anne Pollak 女士。請繼續。

Thank you. This afternoon, DBV Technologies issued a press release that outlines our financial results for the 12 months ended December 31, 2022. This press release is available on the Press Release section of the DBV Technologies website.

謝謝。今天下午，DBV Technologies 發布了一份新聞稿，概述了我們截至 2022 年 12 月 31 日的 12 個月的財務業績。此新聞稿可在 DBV Technologies 網站的新聞稿部分獲取。

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 our product -- of our product candidates to improve the lives of patients with food allergies.

在我們開始之前，請注意，今天的電話會議可能包含一些前瞻性陳述，包括但不限於有關我們的臨床和監管開發計劃的評論、與監管機構互動的時間和結果、我們對現金的預測跑道和我們的產品的能力——我們的候選產品改善食物過敏患者的生活的能力。

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.

這些前瞻性陳述基於的假設存在風險和不確定性，這些風險和不確定性可能導致公司的實際結果與這些陳述所建議的結果存在顯著差異。鑑於這些風險和不確定性，您不應過度依賴這些前瞻性陳述。

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 really 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.

請參閱該公司向 SEC 和法國 AMF 提交的文件，了解可能導致該公司實際業績與預期大相徑庭的風險因素的信息，包括本次電話會議中所做的任何前瞻性聲明。除法律要求外，公司不承擔公開更新或修改任何前瞻性陳述以解釋或反映本次電話會議後發生的事件或情況的義務。

Joining me on today's call are Daniel Tassé, Chief Executive Officer of DBV; Sébastien Robitaille, Chief Final Officer; and Pharis Mohideen, Chief Medical Officer. I will now pass the call over to Daniel. Daniel?

參加今天電話會議的有 DBV 首席執行官 Daniel Tassé； Sébastien Robitaille，首席終審官；和首席醫療官 Pharis Mohideen。我現在將把電話轉給丹尼爾。丹尼爾？

Anne, thank you, and thank you all for joining us on this call this afternoon. In a few moments, Sébastien will walk you through the highlights of the full year 2022 financial results. But before he does that, I'd like to take a few moments to talk about recent clinical updates.

安妮，謝謝您，也感謝大家今天下午參加我們的電話會議。稍後，Sébastien 將帶您了解 2022 年全年財務業績的亮點。但在他這樣做之前，我想花一些時間談談最近的臨床更新。

Last year, our top priority was to finalize the design and protocol of VITESSE, the Phase III pivotal study of the modified Viaskin Peanut patch in children ages 4 to 7 with a confirmed peanut allergy diagnosis. We did that, and we are on track to screen our first patient by the end of the first quarter this year, and we look forward to providing an update when this event occurs.

去年，我們的首要任務是完成 VITESSE 的設計和方案，這是一項針對 4 至 7 歲確診花生過敏兒童的改良 Viaskin 花生貼劑的 III 期關鍵研究。我們做到了，我們有望在今年第一季度末篩查第一位患者，我們期待在這一事件發生時提供最新情況。

Now in advance of initiating VITESSE, we completed a study called EVOLVE, which was a 12-week caregiver and patient user experience study with the modified Viaskin Peanut patch in 50 peanut-allergic children ages 4 to 11 years of age. Now our objective with EVOLVE was pretty straightforward. It was to optimize the eDiary tool that families will use in VITESSE to best capture patch adhesion and patch experience data.

在啟動 VITESSE 之前，我們完成了一項名為 EVOLVE 的研究，這是一項為期 12 週的護理人員和患者用戶體驗研究，研究對象為 50 名 4 至 11 歲的花生過敏兒童，使用改良的 Viaskin 花生貼片。現在我們的 EVOLVE 目標非常簡單。這是為了優化家庭將在 VITESSE 中使用的 eDiary 工具，以最好地捕獲貼片粘附力和貼片體驗數據。

I will invite Pharis to speak in more detail about EVOLVE, what we learn from it as well as also update you all on Viaskin Peanut data that was presented last weekend at the American Academy of Allergy, Asthma, Immunology (sic) [American Academy of Allergy, Asthma & Immunology] Annual Scientific Meeting, the meeting that we all know as AAAAI. Pharis?

我將邀請 Pharis 更詳細地談論 EVOLVE、我們從中學到了什麼，以及上週末在美國過敏、哮喘、免疫學學會（原文如此）[美國過敏學會] 上發布的 Viaskin Peanut 數據的最新情況。過敏、哮喘和免疫學]年度科學會議，我們都知道的會議為 AAAAI。法里斯？

Thanks, Daniel. As Daniel said, EVOLVE was a user experience study designed to provide qualitative data on several study elements that would also be used in the test, our Phase III study in 4- to 7-year olds. In EVOLVE, we tested the functionality of an electronic patient diary called the eDiary to collect information on activities of daily living and patch adhesion scores.

謝謝，丹尼爾。正如 Daniel 所說，EVOLVE 是一項用戶體驗研究，旨在提供幾個研究要素的定性數據，這些數據也將用於測試，即我們針對 4 至 7 歲兒童的 III 期研究。在 EVOLVE 中，我們測試了名為 eDiary 的電子患者日記的功能，以收集有關日常生活活動和貼片粘附評分的信息。

As we have previously discussed, the test will assess patch adhesion of the modified Viaskin Peanut patch, and we will include a statistical test of adhesion into VITESSE stat analysis plan. We've all verified that the eDiary tool can be used by caregivers to capture adhesion data in the test that is required to support a potential BLA application.

正如我們之前討論的，該測試將評估改良 Viaskin 花生貼劑的貼劑粘附力，並且我們將在 VITESSE 統計分析計劃中納入粘附力統計測試。我們都已經驗證，護理人員可以使用 eDiary 工具來捕獲支持潛在 BLA 應用所需的測試中的粘附數據。

I'm also pleased to report that EVOLVE showed that the updated instructions for use, the IFU, supported correct patch application which we defined as no listing of the patch edges or detachment directly after applications. Furthermore, the majority of parents and caregivers reported a positive ease of use experience with the modified Viaskin Peanut patch. We have always believed in the importance of ease of use in a potential peanut allergy treatment profile, and we continue to believe that the overall product profile of Viaskin Peanut will appeal to peanut-allergic family.

我還很高興地報告，EVOLVE 顯示更新的使用說明（IFU）支持正確的補丁應用，我們將其定義為在應用後不直接列出補丁邊緣或分離。此外，大多數家長和看護者都報告了改進的 Viaskin Peanut 貼片的良好易用性體驗。我們始終相信潛在的花生過敏治療方案中易用性的重要性，並且我們仍然相信 Viaskin Peanut 的整體產品概況將吸引花生過敏家庭。

Let's turn now to the American Academy of Allergy, Asthma & Immunology Annual Scientific Meeting, which took place last weekend in San Antonio. AAAAI is among the most important and widely attended meetings on allergy and immunology each year, and DBV had a strong presence this year as we do every year. DBV had 2 EPITOPE posters at the meeting that summarize the efficacy and safety profile of epicutaneous immunotherapy with Viaskin Peanut and peanut-allergic children aged 1 to 3 years with and without certain comorbid atopic conditions.

現在讓我們來看看上週末在聖安東尼奧舉行的美國過敏、哮喘和免疫學學會年度科學會議。 AAAAI 是每年最重要、參與人數最多的過敏和免疫學會議之一，而 DBV 今年的表現與往年一樣強勁。 DBV 在會議上發布了 2 張 EPITOPE 海報，總結了使用 Viaskin 花生和患有或不患有某些共存特應性疾病的 1 至 3 歲花生過敏兒童進行表皮免疫治療的功效和安全性概況。

Specifically, we assessed its treatment response for safety of Viaskin Peanut therapy was influenced by either baseline atopic dermatitis or concomitant food allergy. Both of these conditions are common comorbidities in young children with peanut allergies, each having a reported prevalence rate of 60% to 70%.

具體來說，我們評估了 Viaskin 花生療法安全性的治療反應受到基線特應性皮炎或伴隨食物過敏的影響。這兩種情況都是花生過敏幼兒的常見合併症，據報導每種疾病的患病率為 60% 至 70%。

The results demonstrated consistency in Viaskin Peanut safety and efficacy across multiple patient groups, those with and without other food allergies and atopic dermatitis. Furthermore, treatment with Viaskin Peanut for 1 year did not appear to result in any change in atopic dermatitis severity for children ages 1 to 3 years old.

結果表明，Viaskin Peanut 在多個患者組（有或沒有其他食物過敏和特應性皮炎的患者）中的安全性和有效性是一致的。此外，使用 Viaskin Peanut 治療 1 年似乎並未導致 1 至 3 歲兒童特應性皮炎嚴重程度發生任何變化。

We believe that these EPITOPE data analysis further validate the potential benefit of using the Viaskin platform for the treatment of peanut allergies in young children. For those of you who would like to read the posters in detail that can be found in the Scientific Publications and Presentations section of the DBV website.

我們相信，這些 EPITOPE 數據分析進一步驗證了使用 Viaskin 平台治療幼兒花生過敏的潛在益處。對於那些想要詳細閱讀海報的人，可以在 DBV 網站的科學出版物和演示部分找到這些海報。

At this point, I'll turn the call over to Sébastien to review the financial results. Go ahead, Séb.

此時，我將把電話轉給塞巴斯蒂安，以審查財務結果。繼續吧，塞布。

Thank you, Pharis. Let's briefly review financial highlights for the full year 2022.

謝謝你，法里斯。讓我們簡要回顧一下 2022 年全年的財務亮點。

Cash and cash equivalents were $209.2 million as of December 31, 2022 compared to $77.3 million as of 31st 2021 (sic) [December 31, 2021] which is an increase by $131.9 million, mainly due to $194.1 million in financing activities in Q2. Net cash used in operating activities for the full year was $81.8 million, which is a decrease of 24% compared to prior year, reflecting the cost containment measures that have been continuously maintained since the implementation in 2020.

截至 2022 年 12 月 31 日，現金和現金等價物為 2.092 億美元，而截至 2021 年 31 日（原文如此）[2021 年 12 月 31 日]的現金和現金等價物為 7,730 萬美元，增加了 1.319 億美元，主要是由於第二季度的融資活動為 1.941 億美元。全年經營活動使用的現金淨額為8180萬美元，較上年減少24%，反映了自2020年實施以來持續維持的成本控制措施。

Finally, in the last quarter, our treasury position, which is stated in U.S. dollars benefited from a change in the euro to the U.S. dollar exchange rates. The company's activities and expenditures in the fourth quarter were in line with expectations and continue to maximize the efficiency of our spend and remain highly disciplined in our cash management.

最後，在上個季度，我們以美元表示的財務頭寸受益於歐元兌美元匯率的變化。公司第四季度的活動和支出符合預期，並繼續最大限度地提高支出效率，並保持嚴格的現金管理紀律。

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

我將把電話轉回給丹尼爾，讓他發表結束語。

Thank you, Sébastien. In closing -- can you hear me? Can you hear me?

謝謝你，塞巴斯蒂安。最後——你能聽到我說話嗎？你能聽到我嗎？

Yes.

是的。

Yes, we can hear you.

是的，我們能聽到你的聲音。

Okay. Cool. Sorry about that. So in closing, I'm very pleased with our continued financial discipline and progress across our clinical programs. Looking ahead to the remainder of 2023, we'll continue to keep you updated as appropriate on our VITESSE III -- Phase III trial progress in children ages 4 to 7 as well as our development plans for Viaskin Peanut as a potential treatment for -- in allergic toddlers ages 1 to 3.

好的。涼爽的。對於那個很抱歉。最後，我對我們持續的財務紀律和臨床項目的進展感到非常滿意。展望 2023 年剩餘時間，我們將繼續酌情向您通報我們的 VITESSE III——針對 4 至 7 歲兒童的 III 期試驗進展情況，以及我們將 Viaskin Peanut 作為潛在治療方法的開發計劃—— 1 至 3 歲過敏幼兒。

I want to thank you all on the phone today on the webcast for joining us. And operator, let's open the line for questions, if there are any.

我要感謝今天通過網絡廣播電話加入我們的所有人。接線員，如果有問題的話，讓我們開通提問熱線。

(Operator Instructions) And the first question will come from Charles Wolleben (sic) [Jonathan Wolleben] with JMP.

（操作員說明）第一個問題將來自 JMP 的 Charles Wolleben（原文如此）[Jonathan Wolleben]。

Jon Wolleben here. A few on EVOLVE eDiary study. Wondering if this was requested by FDA. Why 4 to 11 versus 4 to 7? And then did you collect any other data, whether patch adhesion, adhesion type reaction, anaphylaxis or any safety data? Anything else you can learn from the EVOLVE study besides validating the eDiary?

喬恩·沃萊本在這裡。一些關於 EVOLVE eDiary 的研究。想知道 FDA 是否要求這樣做。為什麼是 4 比 11 而不是 4 比 7？然後您是否收集了任何其他數據，無論是貼片粘附、粘附型反應、過敏反應還是任何安全數據？除了驗證電子日記之外，您還可以從 EVOLVE 研究中學到什麼？

I'll have Pharis give you more details. Then to be clear, no, this was entirely our decision. This decision was made when we were contemplating to a new pivotal trial, given that we have a new patch. We also know, Jonathan, that adhesion on application is a mark of adhesion, obviously, through the day. And that would be used an eDiary tool to make sure that we capture all the rich data was required to inform the BLA in the label.

我會讓 Pharis 給你更多細節。然後要明確的是，不，這完全是我們的決定。鑑於我們有新補丁，我們在考慮進行新的關鍵試驗時做出了這一決定。喬納森，我們也知道，塗抹時的附著力顯然是一天中附著力的標誌。這將使用電子日記工具來確保我們捕獲通知標籤中的 BLA 所需的所有豐富數據。

Our decision was made on our own to sort of -- the expression to me was sort of work the yards out to make sure that when we rolled out that tool in VITESSE, a pivotal trial, we were very confident it was the right tool for us, which is what this was intended to do. Again, it was not powered to prove or measure anything. It's something we choose to do or chose to do, again, to make sure that we came into VITESSE confident that we had a good IFU and a good tool to capture the data. Pharis, anything else you want to add to that?

我們的決定是我們自己做出的——對我來說，這就是要努力工作，以確保當我們在 VITESSE 中推出該工具（一項關鍵試驗）時，我們非常有信心它是正確的工具我們，這就是我們的目的。同樣，它沒有能力證明或測量任何東西。這是我們選擇做或再次選擇做的事情，以確保我們進入 VITESSE 時相信我們擁有良好的 IFU 和捕獲數據的良好工具。 Pharis，您還有什麼要補充的嗎？

No, that's correct. But I can answer the other questions, if you would like, Daniel.

不，這是正確的。但如果你願意，我可以回答其他問題，丹尼爾。

Yes, please.

是的，請。

Yes. Okay. So as far as the 4 to 11 versus 4 to 7, so as Daniel said, this was designed to work the [IFU] prior to starting to test. And so with the nature of the objective of the study being let's optimize the eDiary and the instructions for use, it didn't matter whether you were 4 to 7 or you were 4 to 11 as long as you were a peanut-allergic subject, we felt that in a caregiver parent of a peanut- allergic child, we felt that we could generate the same amount of data. And then, of course, recruitment for us is always primary in terms of being effective and efficient. So we wanted to generate the data in a short period of time. So that's the reason for the 4 to 11. Nothing more beyond that.

是的。好的。至於 4 到 11 與 4 到 7，正如 Daniel 所說，這是為了在開始測試之前使 [IFU] 工作而設計的。因此，鑑於研究目標的本質是讓我們優化電子日記和使用說明，只要您是花生過敏的受試者，無論您是 4 到 7 歲還是 4 到 11 歲，都沒有關係，我們認為，對於花生過敏兒童的照顧者父母，我們認為我們可以生成相同數量的數據。當然，對於我們來說，招聘始終以有效和高效為首要考慮。所以我們希望在短時間內生成數據。這就是 4 到 11 的原因。僅此而已。

And in terms of your other question, yes, we collected safety data, a lot of other things, just as we normally was through any other trial and it performed as it always does very consistently relative to other studies that we've seen from a safety standpoint. Does that answer your question, Jon?

至於你的另一個問題，是的，我們收集了安全數據，還有很多其他的東西，就像我們通常通過任何其他試驗一樣，它的表現與我們從其他研究中看到的總是非常一致的。安全立場。這能回答你的問題嗎，喬恩？

Yes. That's helpful. In the prepared remarks, Daniel, you mentioned VITESSE will be up and running this month. Wondering if you could get an update on this 275 subject safety study, you'll also be running, if there's any guidance for when that will be starting. And then also, if you have any update on your progress in the 1 to 3 year olds.

是的。這很有幫助。丹尼爾，在準備好的發言中，您提到 VITESSE 將於本月啟動並運行。想知道您是否可以獲得這項涉及 275 名受試者的安全研究的最新信息，您也會參加，是否有關於何時開始的任何指導。另外，您是否有關於 1 至 3 歲孩子的最新進展。

Yes, I'll have Pharis answer the question on 1 to 3 year olds. The safety trial companies, VITESSE, was meant to enrich the safety database. As you know, the 6-month trial, also 12-month trial, enrollment is going to be faster because 275 obviously is less than 600, but mostly there's no food challenge, which makes enrollment those trials to be a lot easier. So our plan here is to start the safety trial later on towards the sort of plateauing of enrollment in VITESSE as to not compete with ourselves for patients. And we're, again, planning and confident that we can land the completion of the safety trial at the same time or before the database lock of the VITESSE trial. Does that answer your question?

是的，我會讓 Pharis 回答關於 1 到 3 歲孩子的問題。安全試驗公司 VITESSE 旨在豐富安全數據庫。如您所知，6 個月的試驗，也是 12 個月的試驗，註冊會更快，因為 275 顯然少於 600，但大多數情況下沒有食物挑戰，這使得註冊這些試驗變得容易得多。因此，我們的計劃是稍後開始安全試驗，以達到 VITESSE 的入組穩定期，以免與我們自己爭奪患者。我們再次計劃並有信心能夠在 VITESSE 試驗數據庫鎖定的同時或數據庫鎖定之前完成安全試驗。這是否回答你的問題？

Yes. And then that's helpful there. And just wondering about the toddler update, if there is one.

是的。這很有幫助。只是想知道幼兒更新（如果有的話）。

Yes. Please, Pharis.

是的。拜託，法里斯。

As we've said in the past, Jonathan, we'll communicate with the FDA this quarter. Beyond that is probably not prudent to comment in terms of when we would get feedback from them. We'll follow the traditional application processes. So...

正如我們過去所說，喬納森，我們將在本季度與 FDA 進行溝通。除此之外，就何時從他們那裡得到反饋發表評論可能並不明智。我們將遵循傳統的申請流程。所以...

Okay. And one more, if I may. My math might be off, but I see a pretty big jump in R&D this quarter. Wondering if there's any one-off expenses in there or how to think about spend moving forward.

好的。如果可以的話，再來一張。我的數學可能不太好，但我看到本季度的研發有相當大的跳躍。想知道其中是否有任何一次性費用，或者如何考慮未來的支出。

Séb, you want to take the jump in R&D question, which in a start-up cost to VITESSE is mostly what it is. But any more color you want to provide?

Séb，您想在研發問題上邁出一步，這對於 VITESSE 來說主要是啟動成本。但您還想提供更多顏色嗎？

Yes, of course, you're right, Daniel. It's only related to the fact that we will initiate some cost on VITESSE. So we have some upfront with the CROs. So we have, I will say, a slight ramp-up of our R&D expenses in the last few months.

是的，當然，你是對的，丹尼爾。這只是與我們將在 VITESSE 上發起一些費用有關。因此，我們與 CRO 進行了一些預付款。因此，我想說，過去幾個月我們的研發費用略有增加。

So no. It will not carry through, Jonathan. Again, we reiterate that we have enough cash to complete VITESSE in the safety trial with the cushion. If that changes, obviously, we'll communicate that to investors at this point in time. All around good financial discipline, the actual spend as activities planned in Q4 was very much what we had planned when we rolled out the time frame for both studies.

所以不行。它不會持續下去，喬納森。我們再次重申，我們有足夠的現金來完成 VITESSE 的安全試驗與緩衝。顯然，如果情況發生變化，我們將及時向投資者傳達這一情況。圍繞良好的財務紀律，第四季度計劃的活動實際支出與我們在推出兩項研究的時間框架時所計劃的非常相似。

(Operator Instructions) And this will conclude our question-and-answer session as well as our conference call for today. Thank you for attending today's presentation. You may now disconnect.

（操作員說明）我們的問答環節以及今天的電話會議到此結束。感謝您參加今天的演講。您現在可以斷開連接。

Thank you, everyone.

謝謝大家。