DURECT Corp (DRRX) 2023 Q4 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Greetings and welcome to the DURECT Corp fourth-quarter and full-year earnings conference call.

    歡迎參加 DURECT Corp 第四季和全年財報電話會議。

  • (Operator Instructions) As a reminder, this conference is being recorded.

    (操作員指示)謹此提醒,本次會議正在錄製中。

  • It is now my pleasure to introduce your host, Tim Papp, Chief Financial Officer.

    現在我很高興向您介紹主持人蒂姆·帕普 (Tim Papp),他是財務長。

  • Thank you.

    謝謝。

  • Tim, you may begin.

    提姆,你可以開始了。

  • Tim Papp - Chief Financial Officer

    Tim Papp - Chief Financial Officer

  • Good afternoon and welcome to direct Corporation's Fourth Quarter 2023 earnings conference call business.

    下午好,歡迎參加 Direct Corporation 2023 年第四季財報電話會議。

  • Tim Taft Chief Financial Officer of Darex.

    Darex 財務長 Tim Taft。

  • Before we begin, I would like to remind you of our Safe Harbor statements.

    在開始之前,我想提醒您注意我們的安全港聲明。

  • During the course of this call, we may make forward-looking statements regarding direct products and development, expected product benefits, our development plans, future clinical trials or projected financial results.

    在本次電話會議期間,我們可能會就直接產品和開發、預期產品效益、我們的開發計劃、未來的臨床試驗或預期的財務結果做出前瞻性陳述。

  • These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

    這些前瞻性陳述涉及風險和不確定性,可能導致實際結果與此類前瞻性陳述中的結果有重大差異。

  • For further information regarding these and other risks can be found in our SEC filings, including our 10 K and 10 Q under the heading risk factors to begin, I would like to review our fourth quarter and full year 2023 financial results.

    有關這些風險和其他風險的更多信息,請參閱我們向SEC 提交的文件,包括我們在風險因素標題下的10 K 和10 Q,首先,我想回顧一下我們第四季度和2023 年全年的財務業績。

  • Total revenues in 2023 were $8.5 million compared to 19.3 million in 2022.

    2023 年的總收入為 850 萬美元,而 2022 年為 1,930 萬美元。

  • 2023.

    2023 年。

  • Revenues were lower primarily because 2022 revenues included 10 million of milestone payments related to our partner agreement with Inox.

    收入下降主要是因為 2022 年收入包括與我們與 Inox 的合作夥伴協議相關的 1000 萬美元里程碑付款。

  • For the fourth quarter of 2023, revenues were 2.7 million compared to $3.3 million for the prior year.

    2023 年第四季的營收為 270 萬美元,而前一年的營收為 330 萬美元。

  • This decrease is due to lower revenue from collaborations in 2023.

    這一下降是由於 2023 年合作收入減少所致。

  • R&d expense was $29.4 million in 2023 as compared to $36.9 million for the prior year and $5.6 million for the fourth quarter compared with 10 million for the prior year.

    2023 年研發費用為 2,940 萬美元,去年同期為 3,690 萬美元;第四季研發費用為 560 萬美元,去年同期為 1,000 萬美元。

  • The decreases were primarily due to lower clinical trial related expenses as we substantially completed the AFFIRM trial, lower contract manufacturing expenses and lower employee related costs.

    減少的主要原因是我們基本上完成了 AFFIRM 試驗,從而降低了臨床試驗相關費用、降低了合約製造費用以及降低了員工相關成本。

  • Sg&a expenses were $14.4 million in 2023 as compared to 15.9 million for the prior year and 2.7 million for the fourth quarter compared with $4.3 million for the prior year.

    2023 年的銷售、管理及行政費用為 1,440 萬美元,上一年為 1,590 萬美元;第四季為 270 萬美元,上一年為 430 萬美元。

  • These decreases were primarily due to lower patent expenses as well as lower employee expenses.

    這些下降主要是由於專利費用和員工費用的減少。

  • As of December 31st, 2023, we had cash and investments of 29.8 million as compared to $43.6 million at December 31st, 2022, and our cash burn for 2023 was 38.1 million.

    截至 2023 年 12 月 31 日,我們擁有現金和投資 2,980 萬美元,而 2022 年 12 月 31 日為 4,360 萬美元,2023 年的現金消耗為 3,810 萬美元。

  • Excluding net proceeds from financings, we believe our cash on hand is sufficient to fund operations through the end of 2024.

    不包括融資淨收益,我們相信我們手頭上的現金足以為 2024 年底前的營運提供資金。

  • Now I would like to turn the call over to Jim Brown, our Chief Executive Officer, for a business update.

    現在我想將電話轉給我們的執行長吉姆布朗(Jim Brown),以了解最新業務狀況。

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Thank you, Tim, and hello, everyone.

    謝謝蒂姆,大家好。

  • Thank you for joining us today for our fourth quarter 2023 update.

    感謝您今天加入我們的 2023 年第四季更新。

  • Last November, we announced top line results from our first Phase IIb clinical trial, which evaluated last sucrose, sterile and alcohol associated hepatitis.

    去年 11 月,我們公佈了第一個 IIb 期臨床試驗的主要結果,該試驗評估了最後的蔗糖、無菌和酒精相關肝炎。

  • The key takeaway from these results is that patients treated with our sucrose.

    這些結果的主要結論是患者接受了我們的蔗糖治療。

  • Daryl had lower mortality at 90 days compared with patients that received placebo.

    與接受安慰劑的患者相比,達裡爾在 90 天時的死亡率較低。

  • We're excited about the result and believe they show the potential for lifecycle sterile to provide a clinically meaningful survival benefit in these severe AH patients to our knowledge, no previously controlled trial has demonstrated an improvement in mortality of this magnitude in this devastating disease.

    我們對這一結果感到興奮,並相信它們顯示出生命週期無菌的潛力,可以為這些嚴重的AH 患者提供臨床上有意義的生存獲益,據我們所知,之前沒有對照試驗證明這種毀滅性疾病的死亡率有如此大的改善。

  • We also saw an encouraging safety profile for lesser cholesterol with a lower number of adverse events for the active arms as compared to placebo.

    我們也發現,與安慰劑相比,活性組的膽固醇含量較低,且不良事件數量較少,因此安全性令人鼓舞。

  • We are in ongoing communications with the FDA about the design for a potential confirmatory Phase three trial that could serve as the basis for an NDA filing.

    我們正在與 FDA 就潛在的驗證性第三階段試驗的設計進行持續溝通,該試驗可以作為 NDA 備案的基礎。

  • We expect to provide a further update in the second quarter.

    我們預計將在第二季提供進一步的更新。

  • We continue to be encouraged by the overwhelming support of a thought leaders and the broader hepatology community who have had no effective therapy for these patients.

    我們繼續受到思想領袖和更廣泛的肝病學界的壓倒性支持的鼓舞,他們對這些患者沒有有效的治療方法。

  • Our Phase IIb AFFIRM trial was a placebo-controlled, double-blind multinational study with two active arms of 30 milligrams and 90 milligrams of Mexico sterile and a placebo arm of approximately 100 patients each.

    我們的 IIb 期 AFFIRM 試驗是一項安慰劑對照、雙盲多國研究,有兩個活性組(30 毫克和 90 毫克墨西哥無菌)和一個安慰劑組(每個組約 100 名患者)。

  • We allowed physicians to utilize their standard practice for treating age, which allowed for the use of corticosteroids in addition to supportive care, such as fluids and nutritional support as well as antibiotics for infection.

    我們允許醫生利用他們的標準做法來治療年齡,除了支持性護理(例如液體和營養支持以及感染抗生素)之外,還允許使用皮質類固醇。

  • In total, we randomized 307 patients with severe AH from a global network of clinical sites, including leading hospitals in the United States, Australia, the EU and the UK.

    我們總共從全球臨床中心網絡中隨機抽取了 307 名嚴重 AH 患者,包括美國、澳洲、歐盟和英國的領先醫院。

  • Our sites included renowned liver centers, and we had the honor of working with some of the world's preeminent thought leaders in AH., the top line results in the key secondary endpoint of mortality at 90 days showed a 41% reduction, but the 30 milligram dose, that's actually both sterile and a 35% reduction with a 90 milligram dose of Mexico sterile when compared with placebo.

    我們的網站包括著名的肝臟中心,我們很榮幸與美國一些世界傑出的思想領袖合作。90 天的關鍵次要終點死亡率的頂線結果顯示降低了 41%,但 30 毫克劑量,實際上既是無菌的,而且與安慰劑相比,90 毫克墨西哥無菌劑量的劑量減少了35%。

  • We also reported a numerical improvement in the primary endpoint of reduction in mortality or liver transplant at 90 days.

    我們也報告了 90 天死亡率或肝臟移植降低的主要終點的數字改善。

  • So neither the primary or key secondary endpoint results achieved statistical significance even more impressive results were observed in the U.S. population, which comprised three quarters of the total enrollment in a firm that was 232 out of the 307 patients in the U.S. patients, we saw reductions in mortality of 57% and 58% for the 30 and 90 milligram arms, respectively, as compared with placebo.

    因此,主要或關鍵次要終點結果均未達到統計顯著性,甚至在美國人口中觀察到了更令人印象深刻的結果,該公司佔總入組人數的四分之三,在美國307 名患者中,有232 名患者,我們看到了減少與安慰劑相比,30 毫克組和 90 毫克組的死亡率分別為 57% 和 58%。

  • Although not part of the original statistical analysis plan.

    雖然不屬於原始統計分析計劃的一部分。

  • The p-values for these results were both approximately 0.01. Very importantly, our single share all exhibited an excellent safety profile with no serious adverse events in either arm and greater than 20% reductions in the number of treatment emergent adverse events, both active arms in these severely ill patients.

    這些結果的 p 值均約為 0.01。非常重要的是,我們的單一份額均表現出出色的安全性,任一組均未出現嚴重不良事件,並且治療中出現的不良事件數量減少了20% 以上,這兩個治療組均針對這些重症患者。

  • Ultimately, these clinically meaningful reductions in mortality, coupled with the reduction in adverse events in these severely ill patients reinforce the compelling risk reward proposition for luxury goods sterile.

    最終,這些具有臨床意義的死亡率降低,加上這些重症患者不良事件的減少,強化了奢侈品無菌產品令人信服的風險回報主張。

  • We are in active communication with the FDA about the design of a confirmatory Phase three trial in age.

    我們正在與 FDA 就年齡驗證性三期試驗的設計進行積極溝通。

  • We continue to believe that the AFFIRM data provide compelling evidence that our sucrose gel could represent a safe and effective therapy with lifesaving potential for age patients.

    我們仍然相信 AFFIRM 數據提供了令人信服的證據,表明我們的蔗糖凝膠可以代表一種安全有效的療法,並具有挽救老年患者生命的潛力。

  • As a reminder, AH. is the cause of more than 150,000 hospitalizations each year in the U.S. and with a 90-day mortality rate of approximately 30% was responsible for tens of thousands of deaths each year.

    提醒一下,啊。在美國,每年有超過 15 萬人因此住院,90 天死亡率約 30%,每年造成數萬人死亡。

  • There are no effective treatments for age.

    對於年齡,沒有有效的治療方法。

  • Flushing cholesterol meets our expectations in Phase three and we are able to gain approval.

    沖洗膽固醇符合我們在第三階段的預期,我們能夠獲得批准。

  • It would likely be the first FDA approved treatment for this disease.

    這可能是 FDA 批准的第一個治療這種疾病的方法。

  • In addition to its high mortality rate, AH represents a significant cost to the U.S. health care system.

    除了高死亡率之外,AH 也為美國醫療保健系統帶來巨大成本。

  • Hospitalizations attributed to age typically incur costs ranging from 60 to over $160,000.

    因年齡原因住院通常會產生 60 至 160,000 美元以上的費用。

  • This result in a total cost to hospitals of approximately $10 billion annually.

    這導致醫院每年的總成本約為 100 億美元。

  • As a result, our sequel style represents a potential multibillion-dollar opportunity in the United States alone could simultaneously provide overall cost savings to the health care system.

    因此,我們的續集風格代表了一個潛在的數十億美元的機會,僅在美國就可以同時為醫療保健系統節省整體成本。

  • We would now like to take any questions you may have.

    我們現在願意回答您可能提出的任何問題。

  • Operator

    Operator

  • (Operator Instructions) Francois Brisebois, Oppenheimer & Co. Please go ahead.

    (操作員指示)Francois Brisebois,Oppenheimer & Co. 請繼續。

  • Francois Brisebois - Analyst

    Francois Brisebois - Analyst

  • Hey, Tom, can you help us understand maybe a little more of the timing of when the discussions with the FDA took place, how long maybe how long after that, you intend on updating the market?

    嘿,湯姆,你能幫助我們更多地了解與 FDA 進行討論的時間嗎?多久之後,你打算更新市場?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • I think you know right now we're right in the middle of the communication.

    我想你知道我們現在正處於溝通之中。

  • So I don't have a sense I'm going to have some sense, but I really can't share much from where we are now.

    所以我不知道我會有什麼感覺,但我真的無法分享我們現在的情況。

  • I think we'll have to wait for the for the process to complete and then once we have on clarity from them, then we will communicate that in a very rapid fashion.

    我認為我們必須等待該過程完成,一旦我們得到他們的明確訊息,我們將以非常快速的方式進行溝通。

  • Francois Brisebois - Analyst

    Francois Brisebois - Analyst

  • Understood.

    明白了。

  • And then can you help us understand maybe a little bit of the feedback you're getting from physicians from the you know, obviously the publication of the data that you released?

    然後,您能否幫助我們了解您從醫生那裡得到的一些回饋,尤其是您發布的數據的發布?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Yes, it's been just extremely positive.

    是的,這非常積極。

  • As we all know, this disease hasn't had really any major breakthrough as far as being able to help these patients out in more than 40 years.

    眾所周知,這種疾病四十多年來一直沒有真正的重大突破可以幫助這些患者擺脫困境。

  • And in our US population, which was the 232 hundred to 307, we had a 28% mortality, which fits right into that 30% we've been talking about, and that's been in the literature.

    在我們的美國人口中,即 23200 至 307 人中,死亡率為 28%,這正好符合我們一直在談論的 30%,這在文獻中也有記載。

  • It was 100, 50,000 hospitalizations we're talking 40 plus thousand people dying every year in the United States.

    美國每年有 100、5 萬人住院治療,40 多人死亡。

  • That's about as many as die from breast cancer.

    這大約相當於死於乳癌的人數。

  • And it's a horrible circumstance and there's nothing out there so when they see these data and they see 40 50, 60% reduction in mortality and what appears to be a safer alternative to what they're giving today?

    這是一個可怕的情況,什麼都沒有,所以當他們看到這些數據時,他們看到死亡率降低了40%、50%、60%,那麼有什麼比他們今天提供的更安全的替代方案呢?

  • Certainly, we're not seeing anything in the way of increased side effects and potentially fewer of them that mix that matters a lot to them.

    當然,我們沒有看到任何副作用增加以及可能更少的副作用,這對他們來說很重要。

  • So we've got tremendous grassroots support from the physicians who treat these patients and they are looking forward to getting the product out there and have a great number of them have volunteered to help out, I guess the outlet norm and maybe knock on wood, what are you hearing from your colleagues with regard to that, and

    因此,我們得到了治療這些患者的醫生的巨大基層支持,他們期待著將產品推出市場,並且有很多人自願提供幫助,我猜這是出口規範,也許是敲木頭,您從您的同事那裡聽到了哪些關於此事的消息,以及

  • Norman Sussman - Chief Medical Officer

    Norman Sussman - Chief Medical Officer

  • hello, Frank.

    你好,弗蘭克。

  • It's overwhelmingly positive on one one of the I think we were at 10 you're at the big meeting in Boston and one of the leaders, you were one of the very first overall papers on age.

    這是非常積極的,我認為我們 10 歲的時候,你參加了在波士頓舉行的大型會議,並且是領導者之一,你是第一個關於年齡的整體論文之一。

  • When I showed it in said, man, this is the first.

    當我展示它時說,夥計,這是第一個。

  • This is the first positive result in over 30 years.

    這是30多年來的第一個正面結果。

  • It gives you some idea of the level.

    它讓您對級別有一些了解。

  • Yes.

    是的。

  • Francois Brisebois - Analyst

    Francois Brisebois - Analyst

  • Great.

    偉大的。

  • Thank you.

    謝謝。

  • And then maybe can you share how involved with the FDA communications are thought leaders or and just anything about that process or can you not disclose it?

    然後,也許您可以分享思想領袖如何參與 FDA 溝通,或者有關該過程的任何信息,或者您可以不透露嗎?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Yes, probably not.

    是的,可能不會。

  • I mean, typically, the communication between the FDA is between the FDA and the Company has excuse me, what we do involved.

    我的意思是,通常情況下,FDA 之間的溝通是 FDA 和公司之間的溝通,請原諒我們所做的工作。

  • The thought leaders to a large extent as we're looking at worked in the the additional study would look like the Phase three trial, the so they're involved heavily there.

    正如我們所看到的,思想領袖在很大程度上參與了附加研究,看起來就像第三階段試驗,因此他們在那裡大量參與。

  • And we're also having I have people involved thought leaders involved in as we analyze the data because this I've heard a number of people say this is the most comprehensive study that's probably been done in a channel talking over 300 patients.

    當我們分析數據時,我們也讓思想領袖參與其中,因為我聽到很多人說這是可能在一個頻道中對 300 多名患者進行的最全面的研究。

  • We're learning a lot about, you know how this disease is diagnosed and treated globally as well as here in the United States.

    我們正在了解很多關於這種疾病在全球以及美國是如何診斷和治療的。

  • And so as every week or so goes by, we end up learning more from this database and more about this disease and how to approach the disease.

    因此,每隔一周左右,我們最終會從這個資料庫中了解更多信息,了解更多關於這種疾病以及如何應對這種疾病的信息。

  • So it's science.

    所以這是科學。

  • It's really been a just a wealth of information.

    這確實是一個非常豐富的資訊。

  • Francois Brisebois - Analyst

    Francois Brisebois - Analyst

  • Thank you.

    謝謝。

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Sure.

    當然。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Carl Byrnes, Northland Capital Markets.

    卡爾‧伯恩斯,北國資本市場。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Thanks for the question and congratulations on the progress or I'm wondering in the same kind of on the heels of the prior questions.

    感謝您提出問題並祝賀取得的進展,或者我想知道繼之前的問題之後的同樣問題。

  • Do you have any comments on in terms of the FDA's enthusiasm, considering the urgent unmet medical need to treat a age and the compelling US. subject subgroup analysis for August was circa sterile along with the profound safety profile.

    考慮到治療年齡和引人注目的美國迫切的未滿足的醫療需求,您對 FDA 的熱情有何評論?八月的受試者亞組分析幾乎沒有結果,安全性也很高。

  • And then I have a follow-up as well.

    然後我也有後續行動。

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Thanks.

    謝謝。

  • Yes, I wouldn't want to be trying to state what the FDA feel I think they're they're very clinical in their approach and very logical and rational.

    是的,我不想試圖說明 FDA 的感受,我認為他們的方法非常臨床,而且非常合乎邏輯和理性。

  • And so they're they they certainly there are I know at least two physicians in this division that have treated liver patients.

    所以他們是他們,他們當然是我認識的這個部門至少有兩位醫生治療過肝臟患者。

  • So I'm sure that this matters a lot to them, but I don't I couldn't speak to anything beyond that.

    所以我確信這對他們來說很重要,但我不知道,我無法談論除此之外的任何事情。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Okay.

    好的。

  • Fair enough.

    很公平。

  • And then do you have any comment on whether or not you continue to expect that the Phase three would be a US-only enrollment type study?

    那麼您對於是否繼續期望第三階段將是僅限美國的招生類型研究有何評論?

  • Or has there been any change in terms of that thought process?

    或者說這個思考過程有什麼改變嗎?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • No, I don't think so.

    不,我不這麼認為。

  • I think we would still be looking to conduct it.

    我認為我們仍然會尋求進行它。

  • And I'd say, because of the homogeneity of healthcare provision in the United States, we've got a large population there, a huge problem here.

    我想說,由於美國醫療保健服務的同質性,我們那裡人口眾多,這是一個巨大的問題。

  • And the disease is, although it certainly is a global disease and it influences people, unfortunately, everywhere around the world where alcohol is consumed at.

    儘管這種疾病確實是一種全球性疾病,但不幸的是,它影響著世界各地飲酒的地方的人們。

  • And but in the United States, we do have our population.

    但在美國,我們確實有我們的人口。

  • I think we've talked about this.

    我想我們已經討論過這個了。

  • Generally speaking, there were a bit younger than the outside regions of the world also, we tend to have a number of metabolic issues from the guidance that we have.

    一般來說,我們比世界其他地區年輕一些,根據我們的指導,我們往往會出現一些代謝問題。

  • When you combine that with alcohol, you end up with with patients that I think are maybe a bit more predisposed to at this disease.

    當你將其與酒精結合時,我認為患者可能更容易患這種疾病。

  • But that being said, I do believe once this drug has a chance to be tested again, there will be a nice opportunity for both inside the US and outside the U.S. because these diseases are global problem.

    但話雖這麼說,我確實相信一旦這種藥物有機會再次進行測試,對於美國境內和美國境外來說都將是一個很好的機會,因為這些疾病是全球性問題。

  • Carl Byrnes - Analyst

    Carl Byrnes - Analyst

  • Excellent.

    出色的。

  • Thanks so much.

    非常感謝。

  • Yes.

    是的。

  • Operator

    Operator

  • Ed Arce, H.C. Wainwright.

    埃德·阿爾塞,H.C.溫賴特。

  • Thomas Yip - Analyst

    Thomas Yip - Analyst

  • Hi, good afternoon, everyone.

    嗨,大家下午好。

  • This is Thomas Yip asking a couple of questions for ad tech in particular questions.

    我是 Thomas Yip,他問了幾個關於廣告技術的問題,特別是一些問題。

  • So first, just to clarify on that the communications data describing what the FDA is this the end of Phase two meeting and also assuming a path forward is identified by commission meetings.

    首先,我們想澄清一下,在第二階段會議結束時描述 FDA 是什麼的通訊數據,並假設委員會會議確定了前進的道路。

  • Can you just talk about a rough time line to a pivotal readout, specifically how many months for the trial to begin and also how long the study will be finished?

    您能否談談關鍵讀數的粗略時間表,特別是試驗開始的幾個月以及研究將完成多長時間?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • We I wouldn't want to comment on that until we have finished a communication with them around the protocol.

    在我們完成與他們圍繞協議的溝通之前,我們不想對此發表評論。

  • But certainly what we're discussing is a path forward for Phase three to obtain approval for this drug and that much you can take home.

    但當然,我們正在討論的是第三階段的前進道路,以獲得該藥物的批准,並且您可以帶回家。

  • But beyond that, I would wait till the committee.

    但除此之外,我會等到委員會。

  • Thomas Yip - Analyst

    Thomas Yip - Analyst

  • He finished the communication and understood on sense that perhaps found as you are actually part of the year and communications agency.

    他完成了通訊並了解,也許發現你實際上是當年通訊機構的一部分。

  • I'm can you share some preliminary thoughts just internally what we consider to be key elements of this pivotal study, specifically the and some key endpoints that you will focus on?

    您能否在內部分享一些我們認為是這項關鍵研究的關鍵要素的初步想法,特別是您將關注的一些關鍵終點?

  • And also what how large do you anticipate this study will be?

    您預計這項研究的規模有多大?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Yes, I would want to wait until we finished with our dialogue with them, but that will be similar.

    是的,我想等到我們完成與他們的對話,但這將是相似的。

  • I think to what we have seen or if you look at the trial that we just had, we looked at the 232 patients that we dosed within the United States.

    我認為根據我們所看到的情況,或者如果你看看我們剛剛進行的試驗,我們研究了在美國接受給藥的 232 名患者。

  • And we saw this year 60% reduction statistics of boy below 0.01% from 20% fewer adverse events.

    今年我們看到,不良事件減少了 20%,男孩數量減少了 60%,低於 0.01%。

  • Those kind of things coming so I think we've got a good basis to build from as we look for Phase three design, but a little bit of wait till it's done before we talk about a spin-off.

    這些事情即將發生,所以我認為我們在尋找第三階段設計時已經有了一個良好的基礎,但在我們談論分拆之前需要等待一段時間。

  • But I think if you consider it that trial, you'd have to even be in a ballpark.

    但我認為,如果你認為這是審判,你甚至必須在一個大概範圍內。

  • Thomas Yip - Analyst

    Thomas Yip - Analyst

  • And as there are perhaps one more question from this one regarding deals have agreement with Charles River Labs.

    由於這個問題可能還有一個關於與 Charles River Labs 達成協議的交易的問題。

  • And I'm just wondering if you can share some financials with you and the licensing fee there and how the profit share structure between the two companies

    我只是想知道您是否可以與您分享一些財務數據和許可費以及兩家公司之間的利潤分配結構

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • yes, I don't know how much we would share on that on the financials, but I would we have Keith Lui on Alliance and Keith is our Head of Commercial and Business Development and that reports into him.

    是的,我不知道我們會在財務方面分享多少,但我希望我們有 Keith Lui 加入 Alliance,Keith 是我們的商業和業務發展主管,向他報告。

  • So I'll let him kind of speak to the relationship with Charles River and the excitement that we have for being able to work with them.

    所以我會讓他談談與 Charles River 的關係以及我們能夠與他們合作的興奮。

  • Keith?

    基思?

  • Keith Lui - Senior Vice President, Business Development, Commercial, Medical Affairs

    Keith Lui - Senior Vice President, Business Development, Commercial, Medical Affairs

  • Yes, thanks, Jim.

    是的,謝謝,吉姆。

  • I don't think we discussed the financials in particular, but this is the first ever sales and marketing collaboration for deals, that product line that we've had in the US and Canada.

    我認為我們沒有特別討論財務問題,但這是我們在美國和加拿大擁有的產品線的首次銷售和行銷合作。

  • So we are certainly excited about that and done with that important collaboration with as quality of an organization as Charles River that has and a well-known organization worldwide and partnering, particularly with their research models and services group.

    因此,我們當然對此感到興奮,並與 Charles River 這樣的組織進行了重要合作,該組織與全球知名組織合作,特別是與他們的研究模型和服務團隊。

  • And they have a pretty robust sales force out there.

    他們擁有一支相當強大的銷售團隊。

  • It's the presence that we've never had in U.S. or Canada for the of that product line.

    這是我們在美國或加拿大從未有過的該產品線的存在。

  • So and we are really looking forward to the partnership which kicked off just on January first, our sales force is trained, and I think we can report some of the and the positive findings from that relationship in subsequent calls.

    因此,我們真的很期待一月份開始的合作夥伴關係,我們的銷售人員接受了培訓,我認為我們可以在隨後的電話中報告這種關係的一些積極結果。

  • Thomas Yip - Analyst

    Thomas Yip - Analyst

  • Got it.

    知道了。

  • Thank you again for your questions and we look forward to your at the conclusion of your discussions with the FDA for the last there?

    再次感謝您提出問題,我們期待您與 FDA 的最後一次討論結束時?

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • Absolutely.

    絕對地。

  • As do we thank you so much.

    我們也非常感謝你。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • It appears we have no additional questions at this time.

    目前看來我們沒有其他問題。

  • So I'd like to pass the floor back over to Dr. Brown for any additional closing remarks.

    因此,我想將發言權轉回給布朗博士,請他發表補充的結論。

  • James Brown - President, Chief Executive Officer, Director

    James Brown - President, Chief Executive Officer, Director

  • With that, I just want to thank you for your time.

    在此,我只想感謝您抽出寶貴的時間。

  • And as always, if you have additional questions, please reach out to us, and we look forward to catching up.

    像往常一樣,如果您還有其他問題,請聯絡我們,我們期待與您聯繫。

  • Thank you all.

    謝謝你們。

  • Take care.

    小心。

  • Operator

    Operator

  • Ladies and gentlemen, this does conclude today's teleconference.

    女士們、先生們,今天的電話會議到此結束。

  • Once again, we thank you for your participation and you may disconnect your lines at this time.

    我們再次感謝您的參與,此時您可以斷開線路。