Dare Bioscience Inc (DARE) 2023 Q1 法說會逐字稿

Welcome to the conference call hosted by Daré Bioscience to review the company's financial results for the quarter ended March 31, 2023, and to provide a general business update. This call is being recorded. My name is Mallory, and I will be your operator today.

歡迎參加由 Daré Bioscience 主辦的電話會議，回顧該公司截至 2023 年 3 月 31 日的季度財務業績，並提供一般業務更新。此通話正在錄音。我叫馬洛里，今天我將成為您的接線員。

With us today are Sabrina Martucci Johnson, Daré President and Chief Executive Officer; John Fair, Daré's Chief Commercial Officer; and Lisa Walters-Hoffert, Daré's Chief Financial Officer.

今天與我們在一起的有 Daré 總裁兼首席執行官 Sabrina Martucci Johnson； John Fair，Daré 首席商務官；以及 Daré 首席財務官 Lisa Walters-Hoffert。

Ms. Johnson, please proceed.

約翰遜女士，請繼續。

Thank you. Good afternoon and welcome to the financial results and business update call for the quarter ended March 31, 2023, for Daré Bioscience. Our plan today is to review our first-quarter results, discuss development since our recent call on March, and highlight some important objectives and milestones anticipated in 2023.

謝謝。下午好，歡迎參加 Daré Bioscience 截至 2023 年 3 月 31 日的季度財務業績和業務更新電話會議。我們今天的計劃是回顧第一季度業績，討論自 3 月份最近一次電話會議以來的發展情況，並強調 2023 年預期的一些重要目標和里程碑。

Before we begin, I'd like to remind you that today's discussion will include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements made during this call that are not statements of historical facts should be considered forward-looking statements.

在我們開始之前，我想提醒您，今天的討論將包括聯邦證券法含義內的前瞻性陳述，這些陳述是根據 1995 年《私人證券訴訟改革法案》的安全港條款做出的。任何陳述在這次電話會議中所做的並非歷史事實的陳述應被視為前瞻性陳述。

Actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties. You should not place undue reliance on forward-looking statements. Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended March 31, 2023, which was filed today.

由於已知和未知的風險和不確定性，實際結果或事件可能與這些陳述中預期或暗示的結果或事件存在重大差異。您不應過分依賴前瞻性陳述。前瞻性陳述完全符合公司向 SEC 提交的文件中的警示性聲明，包括今天提交的截至 2023 年 3 月 31 日的季度的 10-Q 表格。

I would also like to point out that the content of this call includes time-sensitive information that is current only as of today, May 11, 2023. Daré undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call, except as required by law.

我還想指出，本次電話會議的內容包括截至今天（2023 年 5 月 11 日）的時效性信息。Daré 不承擔更新任何前瞻性陳述以反映此後的新信息或發展的義務致電，除非法律要求。

As a reminder, Daré's diversified portfolio, which includes one FDA-approved product and 12 development-stage candidates, three of which are in or nearing Phase 3 clinical development, is focused solely and squarely on women's health and is built upon the following core principles.

需要提醒的是，Daré 的多元化產品組合包括一種 FDA 批准的產品和 12 種開發階段的候選藥物，其中 3 種處於或接近 3 期臨床開發，完全專注於女性健康，並建立在以下核心原則之上。

Each product candidate must address a meaningful market opportunity in the form of a persistent unmet need. Each product candidate must have the potential to be first line or first in category or both, because we seek to deliver a clear improvement over the standard of care.

每個候選產品必須以持續未滿足的需求的形式解決有意義的市場機會。每個產品候選者必須有潛力成為一線或類別第一或兩者兼而有之，因為我們力求在護理標准上提供明顯的改進。

And ideally, each product candidate has demonstrated proof of concept and/or uses well-characterized active pharmaceutical ingredients which can mitigate development time, cost, and even risk. Our current innovation efforts are focused in contraception, vaginal health, reproductive health, menopause, sexual health, and fertility.

理想情況下，每個候選產品都已證明概念和/或使用特徵良好的活性藥物成分，可以縮短開發時間、成本甚至風險。我們目前的創新工作主要集中在避孕、陰道健康、生殖健康、更年期、性健康和生育方面。

On our recent 2022 financial results and update call, we discussed the key milestones anticipated for the year 2023: Phase 2b RESPOND study topline results for our investigational sildenafil cream for female sexual arousal disorder; the US launch of XACIATO by Organon; the initiation of the Phase 3 clinical study of Ovaprene, our investigational potential first-in-category hormone-free, monthly, intravaginal contraceptive whose US commercial rights are under a license agreement with Bayer, which we expect will be the single pivotal study to support Ovaprene's pre-market application; IND-related activities for DARE-HRT1, which is our investigational 28-day intravaginal ring for hormone therapy for the vasomotor symptoms of menopause; and IND-related activities for DARE-VVA1, our investigational hormone-free intravaginally administered treatment for vulvar and vaginal atrophy; as well as our Phase 3 related clinical study plans for the candidate DARE-HRT1 and Phase 2 clinical study plans for DARE-VVA1; and additionally, DARE-PDM1, which is our investigational vaginal hydrogel formulation of diclofenac to treat primary dysmenorrhea or menstrual cramps, the Phase 1 study conduct and the topline data this year.

在我們最近的 2022 年財務業績和更新電話會議上，我們討論了 2023 年預期的關鍵里程碑：我們用於治療女性性喚起障礙的研究性西地那非乳膏的 2b 期 RESPOND 研究的主要結果； Organon 在美國推出 XACIATO；啟動 Ovaprene 的 3 期臨床研究，這是我們研究的潛在首個無激素、每月一次、陰道內避孕藥，其美國商業權已與拜耳簽訂了許可協議，我們預計這將是支持的單一關鍵研究Ovaprene的上市前申請； DARE-HRT1 的 IND 相關活動，這是我們研究的 28 天陰道環，用於治療更年期血管舒縮症狀的激素療法；以及 DARE-VVA1 的 IND 相關活動，DARE-VVA1 是我們研究中的無激素陰道內給藥治療外陰和陰道萎縮的藥物；以及我們候選DARE-HRT1的3期相關臨床研究計劃和DARE-VVA1的2期臨床研究計劃；此外，DARE-PDM1，這是我們研究的雙氯芬酸陰道水凝膠製劑，用於治療原發性痛經或月經來潮，今年的一期研究進行和主要數據。

On today's call, Lisa will review our first-quarter 2023 financial results shortly. But we will otherwise focus on our anticipated milestones for this quarter, this second quarter of 2023. So mainly, we'll spend our time today on the sildenafil cream, 3.6% Phase 2b RESPOND study topline results and the commercial launch of XACIATO in the US by Organon.

在今天的電話會議上，麗莎將很快回顧我們 2023 年第一季度的財務業績。但我們將重點關注本季度（即 2023 年第二季度）的預期里程碑。因此，今天我們主要關注西地那非乳膏、3.6% 2b 期 RESPOND 研究的主要結果以及 XACIATO 在美國奧加農。

We'll start with the sildenafil cream update, and we will review both the exploratory Phase 2b RESPOND study objectives to provide context for the anticipated upcoming topline data readout. And as importantly, we'll talk about the market dynamics for female sexual arousal disorder, which will highlight why we're so excited to be conducting this Phase 2b study for this yet unserved indication that's analogous to erectile dysfunction in men.

我們將從西地那非乳膏的更新開始，我們將回顧探索性 2b 期響應研究目標，為預期即將發布的頂線數據讀數提供背景。同樣重要的是，我們將討論女性性喚起障礙的市場動態，這將強調為什麼我們如此興奮地針對這一類似於男性勃起功能障礙的尚未得到治療的適應症進行這項 2b 期研究。

I'll then turn the call over to John, who will provide an update on Organon XACIATO launch activities. With sildenafil cream, 3.6%, we're looking to address the lack of physical genital arousal response and sensations and the associated distress that are the hallmark of female sexual arousal disorder or FSAD.

然後我會將電話轉給 John，他將提供 Organon XACIATO 啟動活動的最新信息。我們希望通過 3.6% 的西地那非乳膏來解決缺乏身體生殖器喚起反應和感覺以及相關的痛苦，這是女性性喚起障礙或 FSAD 的標誌。

As I mentioned up front, FSAD is analogous to erectile dysfunction or ED in men, both in terms of the pathophysiology of the condition as well as the target pharmacology. And the addressable markets are also quite comparable in size. As we approach the Phase 2b topline data readout expected this quarter, we wanted to give you a sense of what you can expect.

正如我前面提到的，FSAD 類似於男性勃起功能障礙或 ED，無論是在病理生理學還是目標藥理學方面。潛在市場的規模也相當相似。當我們接近本季度預期的 2b 階段頂線數據讀數時，我們希望讓您了解您可以期待什麼。

First, by way of refresher, previously conducted studies by Daré and our licensor, SST, demonstrated that this cream formulation of sildenafil, which is the same active ingredient as in Viagra, increased blood flow to the female genital tissue, both when assessed to be an internal vaginal probe and when assessed via an external temperature-sensing camera. These data provide the proof of concept that the formulation is achieving its target activity in the tissue, increasing blood flow.

首先，回顧一下，Daré 和我們的許可方 SST 之前進行的研究表明，西地那非的這種乳膏配方（與偉哥的活性成分相同）可以增加流向女性生殖器組織的血流量，這兩種情況均被評估為內部陰道探頭並通過外部溫度傳感攝像頭進行評估。這些數據提供了概念證明，證明該製劑正在組織中實現其目標活性，增加血流量。

Obviously, vaginal probes and genital temperature sensors are not practical endpoints for a Phase 3 program. Thus, the exploratory Phase 2b study was designed to evaluate the performance of the sildenafil cream and to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements, which referred to as patient-reported outcomes, in their at-home setting. So this way, we could identify and select the appropriate patient-reported outcomes to take forward into the Phase 3 program. So that's what we're expecting in the Phase 2b readout.

顯然，陰道探針和生殖器溫度傳感器並不是第三階段計劃的實際終點。因此，探索性 2b 期研究旨在評估西地那非乳膏的性能，並評估多種不同的潛在方法，向女性詢問有關她們生殖器感覺和改善的問題，這被稱為患者報告的結果，在她們的家庭設置。這樣，我們就可以確定並選擇適當的患者報告結果，以推進第三階段計劃。這就是我們在 2b 階段讀數中所期望的。

So as we wait for the Phase 2b RESPOND data readout, it's a great time to also remind everyone why we're so excited about the FSAD opportunity. We've mentioned on numerous calls that it's our belief that the FSAD market could be as large or larger in terms of potential patients as the ED market. We've also mentioned that our product candidate sildenafil cream, 3.6% is the only development-stage program, to our knowledge, that is specifically designed to address the lack of genital arousal symptoms associated with FSAD.

因此，當我們等待 2b 階段響應數據讀出時，也是提醒大家為什麼我們對 FSAD 機會如此興奮的好時機。我們在多次電話會議中提到，我們相信 FSAD 市場在潛在患者方面可能與 ED 市場一樣大，甚至更大。我們還提到，據我們所知，我們的候選產品西地那非乳膏 3.6% 是唯一的開發階段計劃，專門用於解決與 FSAD 相關的生殖器喚起症狀缺乏的問題。

As I mentioned, sildenafil is the active ingredient in Viagra. And our innovative topical cream formulation for women is designed to be used on demand prior to sexual activity and to deliver sildenafil directly to the genital tissue to facilitate vasodilation and increase blood flow directly where needed to improve the physical arousal response to address the lack of those genital arousal sensations commonly associated with FSAD. So sildenafil cream has the potential to be the first FDA-approved product to treat FSAD and create an entirely new market of comparable addressable market size as ED.

正如我提到的，西地那非是偉哥的活性成分。我們針對女性的創新外用乳膏配方旨在在性活動前按需使用，並將西地那非直接輸送到生殖器組織，以促進血管舒張並直接在需要的地方增加血流量，從而改善身體性喚起反應，從而解決這些問題。通常與 FSAD 相關的生殖器喚起感覺。因此，西地那非乳膏有可能成為 FDA 批准的第一個治療 FSAD 的產品，並創造一個與 ED 相當的可尋址市場規模的全新市場。

To put some of the market dynamics into context, we only need to look back to the launch of Viagra in 1998. According to an article published at that time in CNNMoney, there were 2.7 million prescriptions filled for Viagra in its first full quarter on the market. And at that time, that was the most prescriptions ever for any pharmaceutical product in its first quarter on the market. According to the same source, more than 160,000 physicians prescribed the product during that period of time, making it one of the most successful product launches in history and helping to double Pfizer's market cap.

為了了解一些市場動態，我們只需回顧一下 1998 年偉哥的推出。根據當時 CNNMoney 發表的一篇文章，在第一季度，偉哥的處方量達到了 270 萬張。市場。當時，這是任何藥品上市第一季度處方數量最多的一次。據同一消息來源稱，在此期間，超過 160,000 名醫生開了該產品的處方，使其成為歷史上最成功的產品發布之一，並幫助輝瑞公司的市值翻了一番。

It can be challenging to be first as a drug developer; blazing a new path as we are with our exploratory Phase 2b study where, as I mentioned, we need to evaluate a number of different potential ways to ask women questions about their genital sensations and improvements in order to identify and select the appropriate patient-reported outcomes to take forward into the Phase 3 program.

成為第一個藥物開發商可能具有挑戰性；正如我們在探索性 2b 期研究中開闢的新道路，正如我所提到的，我們需要評估許多不同的潛在方法，向女性詢問有關她們生殖器感覺和改善的問題，以便識別和選擇適當的患者報告將成果推進到第三階段計劃。

But that level of uptake that I described in the Viagra launch from both providers and patients is incredibly impressive. And we see a number of similarities between ED and FSAD markets. So principally, in ED, a lack of viable pharmaceutical intervention created a situation where, before Viagra, men had a significant condition which often led to depression, isolation, and frustration. As is now the case with women with FSAD, without a viable intervention for ED like Viagra, men were reluctant to have a conversation or ask their provider for help or information.

但我在偉哥上市時所描述的提供者和患者的接受程度令人難以置信地令人印象深刻。我們發現 ED 和 FSAD 市場之間有許多相似之處。因此，主要是，在 ED 中，缺乏可行的藥物干預造成了一種情況，即在偉哥出現之前，男性患有嚴重的疾病，常常導致抑鬱、孤立和沮喪。正如目前患有 FSAD 的女性的情況一樣，如果沒有像偉哥這樣的可行的 ED 干預措施，男性就不願意進行對話或向其提供者尋求幫助或信息。

According to a 2004 study conducted by the British Medical Journal, the authors noted that men reported that ED affected their personal relationships, often left them feeling embarrassed. And they generally suffered in silence, as many men felt unable to talk to their partners or friends about their condition. The authors also noted that once Viagra became available and when it provided symptom relief, men reported feeling happy and elated as well as great improvements in their wellbeing.

根據英國醫學雜誌 2004 年進行的一項研究，作者指出，男性報告 ED 影響了他們的人際關係，常常讓他們感到尷尬。他們通常保持沉默，因為許多男性感到無法與伴侶或朋友談論自己的病情。作者還指出，一旦偉哥上市並且它能緩解症狀，男性就會報告感到快樂和興高采烈，並且他們的健康狀況也有很大改善。

These findings mirror the insights that we have uncovered about FSAD. We know that women are similarly reluctant to speak about their condition with their partners and often report feeling dissatisfaction with their sex lives, unhappiness, and general frustration due to their sexual problems. We also believe that without an FDA-approved intervention, women are left alone to suffer in silence and are often affected by a feeling of shame or embarrassment.

這些發現反映了我們對 FSAD 的見解。我們知道，女性同樣不願意與伴侶談論自己的狀況，並且經常表示對自己的性生活不滿意、不快樂以及由於性問題而普遍感到沮喪。我們還認為，如果沒有 FDA 批准的干預措施，女性就會獨自默默承受痛苦，並且常常感到羞恥或尷尬。

Given the similarities of ED and FSAD in terms of the pathophysiology of the condition as well as the psychological and emotional impact that we've been discussing, we believe there is enormous unmet need. And we see the potential for a large amount of pent-up demand for a product like sildenafil cream.

鑑於 ED 和 FSAD 在病理生理學以及我們一直在討論的心理和情感影響方面的相似性，我們認為存在巨大的未滿足需求。我們看到了對西地那非乳膏等產品的大量被壓抑的需求的潛力。

Therefore, we're excited to bring our exploratory Phase 2b study to conclusion. This quarter, we plan, as the first step, to report the topline data for a number of the assessment tools that we utilized in the study. Subsequent to reporting the topline results, when we have the full data set from the study, we will formalize our proposals to the FDA regarding the patient population to study and the endpoints to evaluate in the Phase 3 program.

因此，我們很高興能夠得出探索性 2b 期研究的結論。本季度，我們計劃第一步報告我們在研究中使用的許多評估工具的主要數據。報告主要結果後，當我們獲得研究的完整數據集時，我們將向 FDA 正式提出有關要研究的患者群體和第 3 階段計劃中要評估的終點的建議。

In addition to the Phase 2b study, where the product was used at home, we recently announced the initiation of a supplemental thermography study in a clinical study -- in a clinical setting. This Phase 1 thermography study of sildenafil cream is expected to enroll around 15 women and to be completed this year.

除了在家中使用該產品的 2b 期研究之外，我們最近還宣佈在臨床環境中啟動一項補充熱成像研究。西地那非乳膏的第一階段熱成像研究預計將招募約 15 名女性，並於今年完成。

These data are an important part of our comprehensive clinical development and regulatory plan for sildenafil cream and now add to our existing clinical and non-clinical data package to support the ongoing development program. These data are expected to complement the forthcoming clinical findings from our Phase 2b RESPOND trial in preparation for a Phase 3 program.

這些數據是我們西地那非乳膏綜合臨床開發和監管計劃的重要組成部分，現在已添加到我們現有的臨床和非臨床數據包中，以支持正在進行的開發計劃。這些數據預計將補充我們即將推出的 2b 期 RESPOND 試驗的臨床結果，為 3 期計劃做準備。

Our goal is to bring a much-needed solution to the women, estimated to be 10 million in the United States alone, who are distressed and seek treatment for low or no sexual arousal. And with no FDA-approved option to address their condition, our goal is for sildenafil cream to be the first FDA-approved product for women with FSAD as Viagra was for men with ED.

我們的目標是為那些因性喚起低下或無性喚起而苦惱並尋求治療的女性提供急需的解決方案，據估計，僅在美國就有 1000 萬女性。由於沒有 FDA 批准的治療方案來解決她們的病情，我們的目標是讓西地那非乳膏成為 FDA 批准的第一個針對女性 FSAD 的產品，就像偉哥針對男性 ED 一樣。

Now we're not planning on providing detailed updates on the other development programs today, but I do want to note that we've been enjoying working with our collaborator, NICHD of the NIH, on the Ovaprene pivotal study start planned for later this year. And we continue to expect to commence patient enrollment in mid-2023 and what we expect to be the single pivotal contraceptive clinical study required to support the PMA submission for registration.

現在我們不打算提供其他開發計劃的詳細更新，但我確實想指出，我們一直很高興與我們的合作者 NIH 的 NICHD 合作，計劃於今年晚些時候啟動 Ovaprene 關鍵研究。我們繼續預計在 2023 年中期開始患者入組，並預計將成為支持 PMA 註冊申請所需的單一關鍵避孕臨床研究。

I also want to mention that we are thrilled with the interest in our DARE-PDM1 study that is underway in Australia. And as a reminder, this is our investigational product to treat primary dysmenorrhea or menstrual cramps by delivering the non-steroidal anti-inflammatory drug diclofenac vaginally, using our proprietary hydrogel formulation; that same formulation technology that is used in XACIATO.

我還想提一下，我們對澳大利亞正在進行的 DARE-PDM1 研究感興趣感到非常興奮。提醒一下，這是我們的研究產品，通過使用我們專有的水凝膠配方，通過陰道輸送非甾體抗炎藥雙氯芬酸來治療原發性痛經或月經痙攣； XACIATO 中使用的配方技術相同。

The topline data are expected this year. And recent market research suggests that the global market for dysmenorrhea treatment was estimated to be valued at $13 billion in 2022 and that the size of this market is expected to increase to $28 billion by 2029.

預計今年將公佈頂線數據。最近的市場研究表明，2022 年全球痛經治療市場價值估計為 130 億美元，到 2029 年該市場規模預計將增至 280 億美元。

So with those updates on the development programs, I will now turn it over to John to provide a commercial update on the XACIATO launch activities.

因此，隨著開發計劃的更新，我現在將其移交給 John，以提供有關 XACIATO 啟動活動的商業更新。

Thank you, Sabrina. As a reminder, XACIATO, clindamycin phosphate vaginal gel, is lincosamide antibacterial for single-dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients, 12 years of age and older, in the United States.

謝謝你，薩布麗娜。提醒一下，XACIATO（克林黴素磷酸酯陰道凝膠）是一種單劑量陰道給藥的林可酰胺抗菌藥物，適用於治療美國 12 歲及以上女性患者的細菌性陰道病。

The XACIATO story is great validation of our portfolio candidate selection and development strategy. Bacterial vaginosis is the most common vaginal condition in women of reproductive age, estimated to affect approximately 23 million women in the US alone. However, a large number of women with the condition are underserved by currently available products. We believe that we could deliver a novel option.

XACIATO 的故事很好地驗證了我們的投資組合候選人選擇和開發策略。細菌性陰道病是育齡女性最常見的陰道疾病，據估計僅在美國就有約 2300 萬女性受到影響。然而，目前可用的產品卻無法為大量患有這種疾病的女性提供服務。我們相信我們可以提供一種新穎的選擇。

Understanding that differentiation drives value, we designed a Phase 3 study capable of generating the data necessary to support a compelling label. We believe that if we were successful in our clinical development planning, we would be able to create an opportunity for a commercialization collaboration that could drive value. And in regard to securing a collaborator capable of maximizing value, we believe we have been very successful.

了解差異化驅動價值後，我們設計了一項第三階段研究，能夠生成支持引人注目的標籤所需的數據。我們相信，如果我們的臨床開發規劃取得成功，我們將能夠創造一個可以推動價值的商業化合作機會。在尋找能夠實現價值最大化的合作者方面，我們相信我們已經非常成功。

We are thrilled that the women's health company Organon is launching XACIATO and that they will leverage their established NEXPLANON sales team to accelerate XACIATO uptake. With the manufacturing validation activities required to support the commercial launch completed, commercial launch activities are progressing. Given that the sales team for NEXPLANON will be launching XACIATO, we expect that the XACIATO sales team will -- we expect that XACIATO will benefit from Organon's track record of commercial success in the branded women's health category.

我們很高興女性健康公司 Organon 即將推出 XACIATO，並且他們將利用其現有的 NEXPLANON 銷售團隊來加速 XACIATO 的普及。隨著支持商業發布所需的製造驗證活動完成，商業發布活動正在取得進展。鑑於 NEXPLANON 的銷售團隊將推出 XACIATO，我們預計 XACIATO 銷售團隊將——我們預計 XACIATO 將從 Organon 在品牌女性健康類別的商業成功記錄中受益。

Organon believes there's a roughly 90% overlap of healthcare providers or HCPs who prescribe NEXPLANON and have the potential to be prescribers of XACIATO, based on provider treatment patterns. Because of the strong relationships the sales team has with these HCPs in the women's health space, we expect Organon to be well positioned to inform these HCPs about XACIATO, ultimately providing benefits for their patients.

Organon 認為，根據提供者的治療模式，開出 NEXPLANON 處方的醫療保健提供者或 HCP 大約有 90% 的重疊，並且有可能成為 XACIATO 的處方者。由於銷售團隊與這些 HCP 在女性健康領域建立了牢固的關係，我們預計 Organon 能夠很好地向這些 HCP 介紹 XACIATO，最終為他們的患者帶來好處。

As I mentioned on our last update call, Organon has what we believe to be a truly integrated go-to-market plan, targeting all of the key stakeholders -- HCPs, payers, and patients -- in order to quickly drive interest and awareness in XACIATO. With a strong product label and a powerful commercial partner, we are excited about the launch of XACIATO expected this quarter.

正如我在上次更新電話會議中提到的，我們認為 Organon 擁有真正綜合的上市計劃，針對所有主要利益相關者（HCP、付款人和患者），以快速提高興趣和意識在XACIATO。憑藉強大的產品標籤和強大的商業合作夥伴，我們對 XACIATO 預計在本季度推出感到興奮。

And Organon has been working on launch activities. They're taking a holistic approach to the product's introduction, including ongoing work in the areas of non-sales force-related promotional activities and utilization of key symposia and conference events.

歐加農一直致力於發射活動。他們正在採取全面的方法來介紹產品，包括在非銷售人員相關的促銷活動以及利用重要研討會和會議活動等領域正在進行的工作。

Organon had a very prominent precedence at a recent payer-focused industry conference called AMCP, which stands for the Academy of Managed Care Pharmacy. This annual event is one of the key conferences where payers and manufacturers can interact and share key pharmacoeconomic insights and learnings across a broad range of products and therapeutic areas.

Organon 在最近一次名為 AMCP（代表管理護理藥學學院）的以付款人為中心的行業會議上取得了非常突出的領先地位。這項年度活動是重要的會議之一，付款人和製造商可以在其中互動並分享廣泛的產品和治療領域的關鍵藥物經濟學見解和經驗。

Organon shared important insights into the pharmacoeconomic and socioeconomic impact of a bacterial vaginosis diagnosis. And I attended this conference personally, and I really believe this information was very well received by many of the key stakeholders attending the conference as well.

歐加農分享了關於細菌性陰道病診斷的藥物經濟學和社會經濟學影響的重要見解。我親自參加了這次會議，我真的相信這些信息也受到了參加會議的許多主要利益相關者的好評。

In addition to their presence at AMCP and their ongoing work with payers, Organon is planning activities in support of the physician community, including their branded exhibit at the marquee conference in women's health, the American College of Obstetricians and Gynecologists Annual Clinical & Scientific Meeting, commonly referred to in our field as the ACOG meeting. The upcoming ACOG meeting, which takes place later this month, provides unique opportunities to interact with key HCPs focused in women's health, which is critical given the role that OB-GYN offices play in treating patients with bacterial vaginosis.

除了參加 AMCP 以及與付款人持續合作之外，Organon 還計劃支持醫生群體的活動，包括在婦女健康大型會議、美國婦產科醫師學會年度臨床和科學會議上進行品牌展覽，在我們領域通常稱為 ACOG 會議。即將於本月晚些時候舉行的 ACOG 會議提供了與關注女性健康的主要 HCP 進行互動的獨特機會，考慮到婦產科辦公室在治療細菌性陰道病患者方面所發揮的作用，這一點至關重要。

And finally -- I know we touched on this earlier, but it feels worth repeating -- Organon will leverage its established NEXPLANON sales team, which currently focuses on contraception, to maximize XACIATO uptake at launch. And because the vast majority of sufferers of bacterial vaginosis are also women of reproductive age, the NEXPLANON sales force is well positioned to leverage their existing relationships with HCPs in women's health.

最後——我知道我們之前已經談到過這一點，但值得重複一遍——Organon 將利用其現有的 NEXPLANON 銷售團隊（目前專注於避孕）來最大限度地提高 XACIATO 在上市時的吸收率。由於絕大多數細菌性陰道病患者也是育齡女性，因此 NEXPLANON 銷售人員能夠充分利用他們與 HCP 的現有關係來促進女性健康。

So in summary, we believe that XACIATO should be well positioned for commercial success, given the knowledge and experience of Organon's NEXPLANON sales team, coupled with Organon's payer outreach, provider- and patient-centered initiatives. We are working towards the first commercial sale before the end of the second quarter.

總而言之，我們認為，鑑於 Organon 的 NEXPLANON 銷售團隊的知識和經驗，再加上 Organon 的付款人外展、以提供者和患者為中心的舉措，XACIATO 應該處於取得商業成功的有利位置。我們正在努力在第二季度末之前進行首次商業銷售。

And with that, I will now turn the call over to Lisa to provide a financial update.

現在，我將把電話轉給麗莎，以提供最新的財務信息。

Thank you, John. And thanks, everyone, for joining us today. I would now like to summarize Daré's financial results for the quarter ended March 31, 2023, which I will refer to as the current quarter or first quarter.

謝謝你，約翰。感謝大家今天加入我們。我現在想總結一下 Daré 截至 2023 年 3 月 31 日的季度的財務業績，我將其稱為本季度或第一季度。

As you know, Daré's business model is to assemble and advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health and then to monetize the value of those -- our portfolio's clinical and regulatory advances over both the near and long term. The investment required to build an advanced portfolio include corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses.

如您所知，Daré 的商業模式是組裝和推進一系列差異化的候選產品，以滿足我們在女性健康領域發現的有意義的未滿足需求，然後將這些價值貨幣化——我們的產品組合在臨床和監管方面的進步近期和長期。建立先進的投資組合所需的投資包括公司管理費用、投資組合收購和維護成本以及持續的研究和開發或研發費用。

So during the first quarter of 2023, our general and administrative expenses or G&A were approximately $3.3 million. Our R&D expenses, which vary from period to period based on clinical, preclinical, manufacturing, regulatory, and other activities across our entire portfolio, were approximately $5 million and primarily reflected the costs of two of our later-stage programs, including the ongoing sildenafil cream, 3.6% Phase 2b RESPOND clinical trial, and manufacturing and regulatory affairs activities related to Ovaprene. Our comprehensive loss for the quarter was approximately $8 million.

因此，在 2023 年第一季度，我們的一般和管理費用或 G&A 約為 330 萬美元。我們的研發費用約為 500 萬美元，主要反映了我們兩個後期項目的成本，包括正在進行的西地那非，具體取決於臨床、臨床前、製造、監管和我們整個產品組合中的其他活動。霜，3.6% 2b 期響應臨床試驗，以及與 Ovaprene 相關的製造和監管事務活動。我們本季度的綜合虧損約為 800 萬美元。

We ended the first quarter with approximately $19.8 million in cash and cash equivalents. And we had approximately 86.3 million shares of common stock outstanding as of May 10.

第一季度結束時，我們擁有約 1,980 萬美元的現金和現金等價物。截至 5 月 10 日，我們已發行的普通股約為 8630 萬股。

In terms of upcoming milestones and future sources of cash under our license agreement with Organon to commercialize XACIATO, we are entitled to receive $2.5 million following first commercial sale. Thereafter, we will be eligible to receive potential additional milestone payments of up to $180 million, as well as tiered double-digit royalties based on XACIATO's net sales.

根據我們與 Organon 簽署的 XACIATO 商業化許可協議，就即將到來的里程碑和未來的現金來源而言，我們有權在首次商業銷售後獲得 250 萬美元。此後，我們將有資格獲得高達 1.8 億美元的潛在額外里程碑付款，以及基於 XACIATO 淨銷售額的分級兩位數特許權使用費。

We are continuing to explore a variety of options to fund our operations, advance our candidates, monetize the value of our assets, and build shareholder value. As a reminder, these alternatives include, but are not limited to, non-dilutive grants, equity sales, license agreement, structured financings, strategic collaborations and alliances. As we've noted previously, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital needed to meet our objectives and build shareholder value.

我們正在繼續探索各種選擇來為我們的運營提供資金、提升我們的候選人、將我們的資產價值貨幣化並建立股東價值。提醒一下，這些替代方案包括但不限於非稀釋性贈款、股權銷售、許可協議、結構性融資、戰略合作和聯盟。正如我們之前所指出的，我們將努力發揮創造力、協作性和機會主義精神，尋求實現我們的目標和建立股東價值所需的資本。

We also encourage investors to review the more detailed discussion of our financials, our financial condition, liquidity, capital resources, and risk factors in our Form 10-Q for the quarter ended March 31, 2023, which we filed this afternoon, as well as our annual report on Form 10-K for the year ended December 31, 2022, which was filed on March 30, 2023.

我們還鼓勵投資者查看我們今天下午提交的截至 2023 年 3 月 31 日的季度的 10-Q 表格中有關我們的財務狀況、財務狀況、流動性、資本資源和風險因素的更詳細討論，以及我們於 2023 年 3 月 30 日提交的截至 2022 年 12 月 31 日止年度的 10-K 表格年度報告。

I would now like to turn the call back over to Mallory, the operator.

我現在想把電話轉給接線員馬洛里。

(Operator Instructions) Catherine Novack, Jones Research.

（操作員說明）凱瑟琳·諾瓦克，瓊斯研究中心。

Hi, good afternoon. Congrats on the quarter, and thank you so much for taking my question. My first question is about sildenafil cream. Just thinking about the RESPOND study, what kind of endpoints are important for efficacy study that's specifically directed at arousal? And to that point, how are arousal and desire differentiated from the FDA's perspective when you're thinking about a product that's directed specifically at FSAD versus hypoactive desire?

嗨，下午好。祝賀本季度，非常感謝您提出我的問題。我的第一個問題是關於西地那非乳膏。想想 RESPOND 研究，對於專門針對喚醒的功效研究來說，什麼樣的終點是重要的？就這一點而言，當您考慮專門針對 FSAD 和慾望減退的產品時，從 FDA 的角度來看，性喚起和慾望有何區別？

Great questions. Thank you for them. And it's a good reminder of some of the things and maybe we should have also talked about in our prepared comments, because they're great questions to get everyone ready, right, for the day of the readout.

很好的問題。謝謝你們。這很好地提醒了我們一些事情，也許我們也應該在準備好的評論中討論一下，因為它們是讓每個人為宣讀當天做好準備的好問題。

So in terms of the kind of questions that one can ask about genital sensations of arousal, they are conclusive as the name implies. They're questions about what someone might be feeling, right, literally a sensation, a physical sensation, as part of their sexual activity and part of that arousal response to activity.

因此，就人們可以提出的有關生殖器性喚起感覺的問題而言，顧名思義，它們是結論性的。它們是關於某人可能感受到什麼的問題，對吧，字面上是一種感覺，一種身體感覺，作為性活動的一部分和對活動的喚醒反應的一部分。

And you may remember that -- and we've talked about this on past calls -- that we utilize both a combination of already validated questionnaires about sexual functioning that have a lot of domains: questions about orgasm, questions about lubrication, questions about arousal sensations, questions about cognition even, and questions about desire -- things that you talked about. So we use some -- the relevant parts of some validated questionnaires like that.

你可能還記得——我們在過去的電話中討論過這一點——我們利用了已經驗證的性功能問卷的組合，這些問卷有很多領域：關於性高潮的問題，關於潤滑的問題，關於性喚起的問題感覺，甚至關於認知的問題，以及關於慾望的問題——你談到的事情。所以我們使用了一些類似的經過驗證的調查問卷的相關部分。

And then we also included what we're referring to as our exploratory endpoints. And those really came out of interviews with women who have the condition to understand what bothers them, what do they -- what are they not feeling physically, what are the words they use to describe it, and what would they like to see improved. And so those are the type of things that we included in our study.

然後我們還包括了我們所說的探索性終點。這些確實來自對女性的採訪，她們有條件了解什麼困擾著她們，她們做了什麼——她們身體上沒有什麼感覺，她們用什麼詞來描述它，以及她們希望看到哪些方面得到改善。這些就是我們研究中包含的內容。

And to your question, too, about the difference between those kind of questions versus desire disorder, think about what sildenafil does. Sildenafil increases blood flow, right? That is what it does through its mechanism. And so we are really focusing on questions about what sildenafil does and what someone is likely going to feel as a result of that.

對於你的問題，關於這類問題與慾望障礙之間的區別，想想西地那非的作用。西地那非會增加血流量，對嗎？這就是它通過其機制所做的事情。因此，我們真正關注的問題是西地那非的作用以及人們可能會因此感受到什麼。

And that's very different from desire. Desire is interest, right? It's emotional. It's -- are you interested in having a sexual activity? Do you have sexual fantasies, right? It's more that thought aspect of it.

這與慾望有很大不同。慾望就是興趣，對嗎？這是情緒化的。這是——你對性活動感興趣嗎？你有性幻想嗎？更多的是它的思想方面。

And so we do ask questions about that in the trial because I think it's important for us to understand our patients, both the subjects in the study before we enroll them in the study and to understand all the benefits that a product like sildenafil could potentially have. But the focus is really on those genital sensations, right, the physical manifestations as opposed to how interested they are or how much they fantasize.

因此，我們確實在試驗中提出了相關問題，因為我認為在我們將患者納入研究之前了解我們的患者（研究對象）並了解像西地那非這樣的產品可能具有的所有益處對我們來說很重要。但重點實際上是那些生殖器的感覺，對吧，身體的表現，而不是他們的興趣或幻想的程度。

Right. That's helpful. So I understand FDA does not have separate draft guidances for arousal and desire disorders. They're kind of lumped together.

正確的。這很有幫助。所以我知道 FDA 沒有針對性喚起和慾望障礙的單獨指南草案。他們有點混在一起。

Right. Yeah. So what they did is one guidance document, but it is very, very clear that the conditions are different. So what they've done is they have one guidance document that covers both as discrete conditions: female sexual arousal disorder and hypoactive desire disorder. But they are all part of one guidance document.

正確的。是的。所以他們所做的是一份指導文件，但非常非常清楚的是，條件是不同的。因此，他們所做的是製定了一份指導文件，涵蓋了兩種不同的情況：女性性喚起障礙和性慾減退障礙。但它們都是一份指導文件的一部分。

And I think part of that came out of the fact that the desire products -- there are two products now FDA approved for desire disorder. They came before us in terms of approaching the FDA and talking about studies and talking about indications that really led to ultimately the FDA putting out that draft guidance document in 2016 to very clearly try to distinguish the two disorders. They are different, and they certainly don't want, for instance, a product that only demonstrates improvement in one aspect, like desire, to get labeling to imply that they improve arousal because those are two very different things.

我認為部分原因是慾望產品——現在 FDA 批准了兩種用於治療慾望障礙的產品。他們在我們面前與 FDA 接觸，討論了研究並討論了真正導致 FDA 最終在 2016 年發布指導文件草案的指示，以非常明確地試圖區分這兩種疾病。他們是不同的，例如，他們當然不希望一種僅在某一方面（如慾望）有所改善的產品被貼上標籤，暗示它們可以提高性喚起，因為這是兩個截然不同的事情。

And so that's what the guidance document was really intended to do -- was to spell out they're both aspects of sexual dysfunction but they're different and to give examples for sponsors on what the pathway to approval is. And it gives a lot of leeway. That's why we did all this work to align on our exploratory endpoints and align with the FDA, that the Phase 2b really is the validation study for those exploratory endpoints so that we really have an opportunity to take the best, most responsive questions forward into the Phase 3.

這就是指導文件的真正目的——闡明它們都是性功能障礙的兩個方面，但它們是不同的，並為發起人提供了批准途徑的例子。而且它給了很大的迴旋餘地。這就是為什麼我們做了所有這些工作來調整我們的探索性終點並與 FDA 保持一致，2b 期確實是這些探索性終點的驗證研究，以便我們真正有機會將最好、反應最靈敏的問題帶入第三階段。

Got it. No, that's helpful. Thanks again, and congrats on the quarter.

知道了。不，這很有幫助。再次感謝，並祝賀本季度。

Thank you so much. And maybe one other point on that, too, that might be helpful to just, again, help frame it for people that are going to be watching for the topline data. The -- in any clinical trial, your primary outcome measures that you declare as the primary, they have to be -- if you're using a patient-reported outcome, it has to be an already validated questionnaire.

太感謝了。也許這一點上的另一點也可能有助於再次幫助那些將要關注主要數據的人構建它。在任何臨床試驗中，您聲明為主要結果的主要結果測量都必須是，如果您使用患者報告的結果，則它必須是已經經過驗證的調查問卷。

So we were not able to use some of the questions, those very specific questions that women with the condition helped us develop. We were not able to use any of those as our primary or secondary endpoints.

所以我們無法使用一些問題，那些患有這種疾病的女性幫助我們提出的非常具體的問題。我們無法使用其中任何一個作為我們的主要或次要終點。

So those are all our exploratory endpoints. So the primary endpoint really came out of an already validated questionnaire, a sexual function questionnaire of 28 questions and then we use this particular arousal domain of it and then an already established and validated questionnaire around distress. And we use one question out of that. So that's how we came up with the primary endpoints, using those already validated questionnaires.

這些就是我們所有的探索終點。因此，主要終點實際上來自一份已經驗證的問卷，一份包含 28 個問題的性功能問卷，然後我們使用它的這個特定的喚醒領域，然後是一份已經建立並驗證的圍繞痛苦的問卷。我們使用其中的一個問題。這就是我們使用那些已經驗證的調查問卷得出主要終點的方法。

And then the exploratory endpoints use all of the new questions and new way of asking the questions and new descriptive words that came out of our patient interviews. Those are our exploratory endpoints. And that's why our topline data readout will be a little [atraditional], right? A traditional topline data readout usually just has the primary endpoint, but these exploratory endpoints are just as interesting.

然後探索性終點使用所有新問題、新的提問方式以及來自我們患者訪談的新描述性詞語。這些是我們的探索終點。這就是為什麼我們的頂線數據讀數會有點[傳統]，對嗎？傳統的頂線數據讀出通常只有主要終點，但這些探索性終點同樣有趣。

We can't do all of it for the topline data readout because that would just be a little bit much to do quickly, which is why we made the comment that we'll end up having to look at the whole fulsome database before we can decide what goes into Phase 3. But at least for top line, we'll be able to share a combination about the primary, secondary, as well as some of these exploratory endpoints; the fun of being first.

我們無法為頂線數據讀出完成所有這些工作，因為這需要快速完成，這就是為什麼我們評論說我們最終必須查看整個完整的數據庫才能完成決定進入第三階段的內容。但至少對於頂線來說，我們將能夠共享有關主要、次要以及其中一些探索性終點的組合；成為第一的樂趣。

Kumar Raja, ROTH Capital.

庫馬爾·拉賈（Kumar Raja），羅斯資本。

Thanks for taking my questions, and congratulations on the progress. Continuing with the sildenafil cream, what is the expectation in terms of when you will have the full data set?

感謝您回答我的問題，並祝賀我取得的進展。繼續西地那非乳膏，您對何時獲得完整數據集有何期望？

That's a great question. We are trying to work as quickly as we can, right? So as you know, the way the process works is you have the database lock, and then there's -- we'll fairly quickly and short order from that have the topline data, which obviously we will announce very quickly upon getting those topline data.

這是一個很好的問題。我們正在努力盡快工作，對嗎？如您所知，該過程的工作方式是您擁有數據庫鎖定，然後 - 我們將相當快速且簡短地獲得頂線數據，顯然我們將在獲得這些頂線數據後很快宣布。

But then typically, it does take -- we're not talking days. It's more time before you actually get the full -- the complete data set and really have an opportunity to go through all of it very carefully and ultimately compile your clinical study report. That, as you probably well know from other corporate experiences, can take weeks to months for that to happen.

但通常情況下，這確實需要——我們不是在談論幾天。您需要更多時間才能真正獲得完整的數據集，並真正有機會非常仔細地檢查所有數據並最終編寫您的臨床研究報告。正如您可能從其他企業經驗中了解到的那樣，這可能需要數周到數月的時間才能實現。

So obviously, we're motivated to work very quickly. It's something we pride ourselves on in terms of being a smaller company; you can work quickly. But there -- this is a very rich data set. I cannot stress that enough.

顯然，我們有動力快速工作。作為一家規模較小的公司，我們對此感到自豪；你可以很快地工作。但這是一個非常豐富的數據集。我怎麼強調都不為過。

We are asking these women who participated in the study -- they were asked a lot of different questions, a lot of different ways, a lot of different times. And we collect a lot of information about them. And so we don't want to rush this analysis because we are going to blaze the path, hopefully, for the Phase 3 and what's going to happen in Phase 3, not just for us but who comes potentially after us in a program like this if it's successful as we hope it can be.

我們詢問了這些參與這項研究的女性——她們被問了很多不同的問題，以很多不同的方式，在很多不同的時間。我們收集了很多關於他們的信息。因此，我們不想倉促進行此分析，因為我們希望為第三階段以及第三階段將要發生的事情開闢道路，不僅為我們，而且為在這樣的計劃中可能追隨我們的人如果它如我們希望的那樣成功的話。

We want to make sure that what we request from the FDA in the Phase 3 is very (technical difficulty) our formulation favorable as well, right? So that's a long way of me saying it's going to take some time. Know that the time is thoughtful and purposeful and well spent with the shared objective of making sure we take something forward ultimately to the FDA.

我們希望確保我們在第 3 階段向 FDA 提出的要求也非常（技術難度）對我們的配方有利，對吧？所以我說這需要一些時間。要知道，我們花的時間是深思熟慮的、有目的的，我們的共同目標是確保我們最終向 FDA 提交一些東西。

Obviously, as quickly as we can, we want to move the data as we hope we want to move this forward as fast as we possibly can. But we also know we only get -- you get that one opportunity to present this to the FDA and what we want to take forward. So we're going to want to make sure we're thoughtful in that.

顯然，我們希望盡可能快地移動數據，因為我們希望盡可能快地推動這一進程。但我們也知道我們只會得到——你得到一次機會向 FDA 展示這一點以及我們想要推進的內容。所以我們要確保我們在這方面是深思熟慮的。

Okay. And with -- regarding to the thermography study, how many sites will you be conducting that study in, and how will that be like [viewed] in with this complete data before you present it to the FDA?

好的。關於熱成像研究，您將在多少個地點進行該研究，以及在將完整數據提交給 FDA 之前[查看]情況如何？

Yeah, so great question. So it's one site that we're working with, and these studies are very specific in their conduct. So there are only actually, in the whole world, less than a handful of sites that can do these kind of sexual health thermography studies, because they're very specific in types -- in terms of the type of equipment you use, in terms of the type of setup you need to have in order to do the study, and the conduct. So we worked with one site for the first thermography study that we did, and we're working with one of the other sites that has the capacity to do this for this particular study.

是的，很好的問題。所以這是我們正在合作的一個網站，這些研究的行為非常具體。因此，實際上，全世界只有不到幾個網站可以進行此類性健康熱成像研究，因為它們的類型非常具體 - 就您使用的設備類型而言，就而言進行研究和進行研究所需的設置類型。因此，我們與一個站點合作進行了我們所做的第一個熱成像研究，並且我們正在與其他有能力為這項特定研究做到這一點的站點之一合作。

And what they can be very helpful in is helping you understand time to effect and what that time-to-effect curve looks like. Obviously, we did one of them purposely before the Phase 2b study, and that's what determined our dosing regimen. And in the Phase 2b, we gave a window of 10 to 20 minutes, when the woman would need to dose the product in advance of a sexual activity.

它們非常有幫助的是幫助您了解生效時間以及生效時間曲線是什麼樣的。顯然，我們在 2b 期研究之前特意做了其中一項，這就是決定我們的給藥方案的原因。在第 2b 階段，我們給出了 10 到 20 分鐘的時間窗口，女性需要在性活動前服用該產品。

So having some additional data around that is very helpful. And also, data in terms of how quickly it separates from placebo is very helpful for us. And so we had that great -- some of that great data going into the Phase 2b. But we think it's very powerful to have a more fulsome data set, again, on that as we prepare for discussions with the FDA for the ultimate Phase 3 plan.

因此，擁有一些額外的數據非常有幫助。而且，關於它與安慰劑分離的速度的數據對我們非常有幫助。因此，我們獲得了很棒的數據，其中一些很棒的數據進入了 2b 階段。但我們認為，在我們準備與 FDA 討論最終的第三階段計劃時，擁有更豐富的數據集是非常強大的。

But that's what we're really looking at. We're looking at, what is the placebo curve and vehicle curve and active curve, what are the -- no curve -- no product, right? What does that all look like? And what is that time when you're seeing that maximum separation so that as we plan our go-forward program, we're really making sure we're taking a lot of very specific data into consideration, particularly before going into Phase 3.

但這才是我們真正關注的。我們正在研究，什麼是安慰劑曲線、載體曲線和活性曲線，什麼是——沒有曲線——沒有產品，對吧？這一切看起來是什麼樣的？當你看到最大分離的時候是什麼時候，以便在我們規劃我們的前進計劃時，我們確實確保考慮到許多非常具體的數據，特別是在進入第三階段之前。

Okay. That's great. And maybe finally in terms of Ovaprene, maybe just provide some highlights. Like, is everything going as expected for the mid-2023 trial start?

好的。那太棒了。也許最後在 Ovaprene 方面，也許只是提供一些亮點。比如，2023 年中期試驗開始時一切都按預期進行嗎？

Yeah. No, we're super excited. So the NICHD has been fantastic to work with. They started doing work and prepping the core sites that we're going to have in the study, which were part of their contraceptive clinical trials network -- you may remember -- back in December of last year, which was super helpful because they also gave great kind of insights on the protocol in terms of operationally and conduct and then, obviously, manufacturing activities, as Lisa talked about, in terms of things we've been spending on; obviously, pivotal study supplies, all of that, which is important to have for the study.

是的。不，我們非常興奮。因此，與 NICHD 的合作非常愉快。他們開始做工作並準備我們將在研究中擁有的核心站點，這是他們避孕臨床試驗網絡的一部分——你可能還記得——早在去年 12 月，這非常有幫助，因為他們也在操作和行為方面對協議提供了很好的見解，然後，顯然，正如麗莎談到的，在我們一直在支出的事情方面，製造活動；顯然，關鍵的研究提供了所有這些，這對於研究來說很重要。

So things have been shaping up nicely. As you know, part of the time we have said was also regulatory time. You may remember that the IND approval from the FDA came with some comments of things that wanted to -- comments on things we might want to consider for the pivotal study to help really make sure it's that one pivotal study for registration.

所以事情進展順利。大家知道，我們所說的部分時間也是監管時間。您可能還記得 FDA 的 IND 批准附帶了一些我們想要考慮的事項的評論 - 關於我們可能想要考慮的關鍵研究的評論，以幫助真正確保這是一項註冊的關鍵研究。

So we've been working on all of that and are feeling really good about where we are now and the site's excitement and enthusiasm for the study, as well as the NIH's enthusiasm for working with us on that. So we're feeling like we're in really good shape, and everything's moving forward as planned right now.

因此，我們一直在致力於所有這些工作，並且對我們現在的處境以及該網站對這項研究的興奮和熱情以及 NIH 與我們合作的熱情感到非常滿意。所以我們感覺我們的狀態非常好，現在一切都在按計劃進行。

Okay. Great. Thanks so much.

好的。偉大的。非常感謝。

Yup.

是的。

Kemp Dolliver, Brookline Capital.

坎普·多利弗（Kemp Dolliver），布魯克萊恩資本。

Good afternoon. I'm going to ask about XACIATO, and the context of the question (multiple speakers) --

下午好。我要問有關 XACIATO 的問題，以及問題的背景（多個發言者）——

Thank you. We're excited about XACIATO, too.

謝謝。我們也對 XACIATO 感到興奮。

Yes. So your milestones dependent upon the first commercial sale, which is a pretty low bar in the grand scheme of things and I have -- it does appear to be getting some formulary coverage. And I think the real heart of my question is, given all this talk about launch and the fact that you haven't say -- aren't saying that you've had the first sale yet, that tells me that there's a question about the timing of when Organon is actually detailing it. Have they started detailing the product or --?

是的。因此，你的里程碑取決於第一次商業銷售，這在宏偉的計劃中是一個相當低的門檻，而我——它似乎確實得到了一些規定的覆蓋。我認為我的問題的真正核心是，考慮到所有關於發布的討論以及您沒有說的事實 - 沒有說您已經進行了第一次銷售，這告訴我有一個關於奧加農實際詳細說明它的時間。他們已經開始詳細介紹產品了嗎？或者——？

Yeah. Great.

是的。偉大的。

Yeah, a few weeks away.

是的，還有幾週時間。

Yeah, it's a great question for us to clarify. So as John mentioned in his comments, there's -- and we've been talking about, right? And as you just noted, in terms of formulary and payer and all that, they are activities that started last year, frankly, around -- those activities that we would all characterize as launch activities, right? So launch activities have been underway.

是的，這是一個非常值得我們澄清的問題。正如約翰在評論中提到的，我們一直在談論，對吧？正如您剛才指出的，就處方和付款人等而言，坦率地說，它們是去年開始的活動，圍繞我們都將這些活動定性為啟動活動，對吧？因此，發射活動一直在進行中。

Obviously, there is a big important marquee conference, as John noted, in the women's health space happening in May. And as John also noted, there were -- and we've mentioned on past calls -- there were manufacturing validation activities that had to happen before you could put product in the channel, right? So with the manufacturing validation activities required to support that commercial launch now completed, that really allows us into that next phase of the commercial launch activities that, to your point, achieve that low bar of that first commercial sale.

顯然，正如約翰指出的那樣，五月份將在女性健康領域舉辦一場重要的大型會議。正如約翰還指出的那樣，我們在過去的電話中提到過，在將產品放入渠道之前必須進行製造驗證活動，對嗎？因此，隨著支持商業發布所需的製造驗證活動現已完成，這確實使我們能夠進入商業發布活動的下一階段，按照您的觀點，實現首次商業銷售的低標準。

And that's why we're guiding that with -- everything that's happening with obviously ACOG being a very important big branded exhibit event for this product. Obviously, that's happening this month, in May. That's where we're saying, look, the anticipation is second quarter.

這就是為什麼我們要引導這一點——顯然 ACOG 是該產品的一個非常重要的大品牌展覽活動。顯然，這將發生在這個月，即五月。這就是我們所說的，看，預期是第二季度。

Okay, super. And the product is in-licensed, and I think you have to share the economics with the licensor and -- or licensee. And so will that apply to the milestones and the royalties?

好吧，超級。該產品已獲得許可，我認為您必須與許可人和被許可人分享經濟效益。那麼這是否適用於里程碑和版稅？

Yes. So taking a step back in terms of just in general at Daré, because I think it's an important thing to understand. Our portfolio is built of products in women's health that we selected based on the indication we wanted to treat, that we identified is having that -- kind of going back to the beginning of the call -- the three things I talked about that are so important to us in terms of making sure we're bringing ultimately to market very differentiated products that have considerable market opportunities.

是的。因此，就 Daré 的總體情況而言，我們退後一步，因為我認為理解這一點很重要。我們的產品組合由女性健康領域的產品組成，我們根據我們想要治療的適應症選擇這些產品，我們確定這些產品具有——有點回到電話開頭——我談到的三件事是如此對我們來說很重要的是，確保我們最終將具有巨大市場機會的差異化產品推向市場。

So you start with the need; you identify that. You design that target product profile, and you go look for the product. And what that means, therefore, by design, is that in our portfolio, someone else has likely invented it, right? And so there are financial obligations that we owe to a third party.

所以你從需求開始；你確定這一點。您設計目標產品概況，然後去尋找產品。因此，從設計上來說，這意味著在我們的產品組合中，很可能是其他人發明的，對吧？因此，我們對第三方負有財務義務。

But we built our company knowing that was our strategy and that we would not, as a company, find ourself in a place where we have to bear the expense of commercialization, right? You heard Lisa talk about our burn. Our burn is so low despite the fact that we have 12 products in active development, and it stays low relatively, right? Because we have been able to enter into commercialization partnerships.

但我們在建立公司時知道這是我們的戰略，並且作為一家公司，我們不會發現自己處於必須承擔商業化費用的境地，對吧？你聽到麗莎談論我們的燒傷。儘管我們有 12 種產品正在積極開發，但我們的燒錢率仍然很低，而且相對較低，對嗎？因為我們已經能夠建立商業化合作夥伴關係。

So knowing that we are going to do that up front, all of our transactions, all of our in-license transactions are designed to support exactly what you talked about, that we're going to get money from someone. And we are likely going to owe money to someone else. But ultimately, that has to make sense for our shareholders because, ultimately, that's who we are working for, right? And so we look at all of that.

因此，我們知道我們將預先這樣做，我們所有的交易，我們所有的許可內交易都是為了支持您所說的，我們將從某人那裡得到錢。我們很可能會欠別人錢。但最終，這必須對我們的股東有意義，因為最終，這就是我們為之工作的人，對吧？所以我們看看這一切。

Our deals are all very different. Every transaction is different depending on the indication, the opportunity, the likely downstream transaction that we're going to have, and the nature of the product. So in this case, but generally to your point, they do include some milestones and royalties to the other party.

我們的優惠都非常不同。每筆交易都是不同的，具體取決於指示、機會、我們可能進行的下游交易以及產品的性質。因此，在這種情況下，但一般來說，就您的觀點而言，它們確實包括一些里程碑和向另一方支付的版稅。

In this transaction, we have $180 million, as Lisa talked about, in terms of milestones that we're eligible to receive from Organon on top of the double-digit tiered royalties. In this case, our licensor, the milestones are quite low. And I can let Lisa talk to them specifically because we've disclosed them. So they're no way or near the $180 million.

正如麗莎所說，在這筆交易中，除了兩位數的分級特許權使用費外，我們還有資格從 Organon 獲得 1.8 億美元的里程碑。在這種情況下，我們的許可方，里程碑相當低。我可以讓麗莎專門與他們交談，因為我們已經披露了它們。所以他們根本不可能或接近 1.8 億美元。

Yeah, no. And thank you, Sabrina. And exactly what she was describing, each deal is different. But with our license -- so this is to obtain the rights to the product, our license agreement with MilanaPharm -- we will only owe them one commercial milestone. And we've disclosed that that's $1 million when the net sales are over $50 million. And then just Sabrina -- and so that's it on commercial milestones, and everything else is a low royalty based on net sales.

是的，不。謝謝你，薩布麗娜。正如她所描述的那樣，每筆交易都是不同的。但有了我們的許可——這是為了獲得產品的權利，我們與 MilanaPharm 的許可協議——我們只欠他們一個商業里程碑。我們透露，當淨銷售額超過 5000 萬美元時，這一數字為 100 萬美元。然後只有薩布麗娜 - 這就是商業里程碑，其他一切都是基於淨銷售額的低版稅。

Yeah. And then there is the 500,000 on the first commercial sale, right?

是的。然後是第一次商業銷售的 500,000，對嗎？

Yeah.

是的。

Okay. So there's a -- and the way to think about --

好的。所以有一個——以及思考的方式——

(multiple speakers) that helps.

（多個發言者）有幫助。

Yeah.

是的。

Go ahead.

前進。

Yeah, the way to think about how the royalty works is in a way you're keeping a, for lack of a better term, a spread between what you're getting from -- or will get from Organon versus what you'll pay out?

是的，考慮特許權使用費如何運作的方式是，您在從 Organon 獲得或將從 Organon 獲得的費用與您將支付的費用之間保持一個價差（由於缺乏更好的術語）出去？

Yeah, absolutely. There's -- obviously, there's a spread on just the royalty part, and then there's a spread, as we were just talking about, specifically on the milestones, which are two different -- those are two different revenue streams coming into Daré.

是的，絕對是。顯然，只有版稅部分存在利差，然後正如我們剛才所說，特別是在里程碑上，這是兩個不同的，這是 Daré 的兩種不同的收入來源。

Great, thank you.

太好了謝謝。

Absolutely. Yeah, thanks.

絕對地。是的，謝謝。

Doug Tsao, H.C. Wainwright.

曹道格 (Doug Tsao)溫賴特。

Hi, good afternoon. Thanks for taking my question. Just curiosity with XACIATO. Do you know -- will this be available at the pharmacy, or will this be distributed through a specialty pharmaceutical -- specialty pharmacy?

嗨，下午好。感謝您提出我的問題。只是對 XACIATO 感到好奇。您知道嗎——這可以在藥房買到，還是通過專業藥品——專業藥房分發？

Yeah, at the pharmacy. And I don't know, John, if you want to say any other comments on this but just --

是的，在藥店。我不知道，約翰，你是否還想對此發表任何其他評論，但只是——

Yeah. Just like every kind of broad women's health product, it's going to be available through the pharmacy. So the retail outlet is where you'll see the product show up.

是的。就像各種廣泛的女性保健產品一樣，它可以通過藥房購買。因此，零售店是您看到產品展示的地方。

Yeah. And -- go ahead, Doug.

是的。還有——繼續吧，道格。

No, I was going to ask, as a follow-up, do we have a sense of the tech transfer and the timing for Organon taking on the manufacturing?

不，我想問的是，作為後續行動，我們是否了解技術轉讓以及 Organon 承擔製造的時機？

Yeah, great question. So as -- and just for the benefit of others, so our agreement with Organon does have us today -- Daré is still overseeing the manufacturing activity and then is the holder of the marketing authorization. But it does contemplate that at some time, Organon will take over those manufacturing responsibilities.

是的，很好的問題。因此——而且只是為了他人的利益，所以我們今天確實與 Organon 達成了協議——Daré 仍在監督製造活動，然後是營銷授權的持有者。但它確實考慮到，在某個時候，歐加農將接管這些製造職責。

And we've obviously, together, have been working on that. These things take time. So XACIATO -- it's part of what we love about XACIATO because it's part of -- in addition to intellectual property -- part of what protects the brand. It's a very specific technology in order to make that hydrogel technology.

顯然，我們一直在共同努力解決這個問題。這些事情需要時間。因此，XACIATO——這是我們喜愛 XACIATO 的原因之一，因為除了知識產權之外，它也是保護品牌的一部分。為了製造水凝膠技術，這是一項非常特殊的技術。

It does require obviously certain equipment and certain processes and all of that good stuff. So we have obviously started the tech transfer process but just mechanistically this time in terms of things that are needed, equipment that is needed, that is specialized in order to make XACIATO. And then there's also just the regulatory piece of the process of switching manufacturers.

顯然，它確實需要某些設備和某些流程以及所有這些好東西。因此，我們顯然已經開始了技術轉讓過程，但這次只是機械地涉及製造 XACIATO 所需的東西、所需的設備。此外，還有更換製造商過程中的監管部分。

So both parties are working hard at this, but this is not a -- just to set everyone's expectations appropriately, a tech transfer for something like this in this manner, where it's not just a CDMO, where it's truly going to transfer hands from a regulatory perspective as well, is a process that takes time. This is not a tomorrow thing. This is something that takes time and effort from both parties, and we are working diligently together on it.

所以雙方都在努力做這件事，但這不是——只是為了適當地設定每個人的期望，以這種方式進行類似的技術轉讓，它不僅僅是一個 CDMO，而是真正從一個 CDMO 手中移交。從監管角度來看，這也是一個需要時間的過程。這不是明天的事情。這是需要雙方時間和努力的事情，我們正在共同努力。

Okay, great. Thank you so much.

好的，太好了。太感謝了。

Yeah, absolutely.

是的，絕對是。

There are no further questions at this time.

目前沒有其他問題。

Great. Well, thanks, first of all, for the great questions. We really appreciated the opportunity to share our thoughts on some of the upcoming milestones this quarter and spending some time on that end this year. And thanks, everyone, for taking the time this afternoon to hear about the recent updates and our ongoing commitment to drive value for all of Daré's stakeholders. We've talked about the shareholders today, but obviously the women and the healthcare providers.

偉大的。嗯，首先感謝您提出的好問題。我們非常感謝有機會分享我們對本季度即將到來的一些里程碑的想法，並在今年為此花費了一些時間。感謝大家今天下午抽出時間來了解最新動態以及我們為 Daré 所有利益相關者創造價值的持續承諾。我們今天討論了股東，但顯然是女性和醫療保健提供者。

And with our diverse portfolio, we really seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing that expand the treatment options where none exists; enhance outcomes, where current standard of care has meaningful shortcomings; and improve ease of use for women, where a more compelling form factor can drive adoption primarily in the areas we've been talking about and some that we haven't touched on today, be it contraception, vaginal health, reproductive health, menopause, sexual health, and fertility.

憑藉我們多樣化的產品組合，我們真正尋求將差異化的處方療法推向市場，優先考慮女性的健康和福祉，從而擴大不存在的治療選擇；當前護理標準存在明顯缺陷的情況下，提高治療效果；並提高女性使用的便利性，更引人注目的外形因素可以主要推動我們一直在談論的領域以及我們今天尚未觸及的一些領域的採用，無論是避孕、陰道健康、生殖健康、更年期，性健康和生育能力。

So we very much look forward to keeping you updated on our progress and the milestones anticipated this year that I outlined earlier, which include the XACIATO product launch and first commercial sale and milestones associated also with our three candidates in or nearing Phase 3 clinical development. And so to list all the milestones again for 2023 that we've talked about, we have the Phase 2b RESPOND topline study results for the sildenafil cream, study for female sexual arousal disorder. So this quarter is what we're targeting on that. Similarly, this quarter, the US first commercial sale of XACIATO by Organon.

因此，我們非常期待向您通報我之前概述的我們的進展和今年預期的里程碑，其中包括 XACIATO 產品發布和首次商業銷售，以及與我們處於或接近 3 期臨床開發的三個候選藥物相關的里程碑。因此，為了再次列出我們討論過的 2023 年的所有里程碑，我們有西地那非霜的 2b 期響應頂線研究結果，即針對女性性喚起障礙的研究。因此，本季度就是我們的目標。同樣，本季度，由 Organon 首次在美國商業銷售 XACIATO。

In addition, as we've talked about, the initiation of that Phase 3 clinical study of Ovaprene, which is our investigational potential first-in-category hormone-free, monthly, intravaginal contraceptive whose US commercial rights are under a license agreement with Bayer. And again, as we've talked about, we expect that to be a single pivotal study to support Ovaprene's pre-market application.

此外，正如我們所討論的，Ovaprene 的 3 期臨床研究已啟動，這是我們正在研究的潛在首個無激素、每月一次、陰道內避孕藥，其美國商業權利是根據與拜耳的許可協議獲得的。再次，正如我們所討論的，我們預計這將成為支持 Ovaprene 上市前應用的一項關鍵研究。

We didn't, other than to mention them, talk about these in detail today but as we mentioned: the IND-related activities for DARE-HRT1, which is our investigational 28-day intravaginal ring for hormone therapy for the vasomotor symptoms and menopause; and DARE-VVA1, our investigational hormone-free intravaginal-administered treatment for vulvar and vaginal atrophy; so Phase 3 and Phase 2 activities, respectively, for those and clinical study initiation plans for those candidates.

除了提及它們之外，我們今天沒有詳細討論這些，但正如我們提到的：DARE-HRT1 的 IND 相關活動，這是我們研究的 28 天陰道內環，用於治療血管舒縮症狀和更年期的激素療法; DARE-VVA1，我們正在研究的無激素陰道內給藥治療外陰和陰道萎縮的藥物；因此，分別針對這些候選者進行第 3 階段和第 2 階段活動，以及針對這些候選者的臨床研究啟動計劃。

And then -- mentioned PDM1, which is our investigational vaginal hydrogel formulation of diclofenac for menstrual cramps. Very much looking forward to that Phase 1 study completion, which is underway right now, and then the topline data this year.

然後提到 PDM1，這是我們研究的用於治療月經痙攣的雙氯芬酸陰道水凝膠製劑。非常期待目前正在進行的第一階段研究的完成，以及今年的頂線數據。

So that's all just for 2023. So thank you again for your time today, and we look forward to keeping you updated.

以上就是 2023 年的全部內容。再次感謝您今天抽出時間，我們期待為您提供最新消息。

This concludes today's conference call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連接。