Blue Water Acquisition Corp III (BLUWU) 2022 Q1 法說會逐字稿

Thank you for joining in the Clarus First Quarter 2022 Financial and Operating results conference call. Today's call is being recorded and webcast live on the company's website at www.clarustherapeutics.com in the Investor Relations section and will be available for replay for 10 days following this live call.

感謝您參加 Clarus 2022 年第一季財務與營運績效電話會議。本次電話會議將進行錄音，並在公司網站 www.clarustherapeutics.com 的「投資者關係」欄位進行網路直播。直播結束後，錄音回放將保留 10 天。

Please note that discussions today may include forward-looking statements. These forward-looking statements include statements regarding the market opportunity for JATENZO, the anticipated benefits of recent patient initiatives and statements regarding the Clarus growth strategy, its pipeline and IP portfolio among others.

請注意，今天的討論可能包含前瞻性陳述。這些前瞻性陳述包括關於JATENZO市場機會的陳述、近期病患計畫的預期收益，以及關於Clarus成長策略、其產品線和智慧財產權組合等方面的陳述。

Forward-looking statements involve a number of risks, uncertainties, some of which are beyond Clarus' control or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.

前瞻性陳述涉及許多風險和不確定性，其中一些風險和不確定性超出了 Clarus 的控制範圍，或存在其他假設，這些因素可能導致實際結果或績效與這些前瞻性陳述所表達或暗示的結果或績效有重大差異。

These risks and uncertainties include but are not limited to the risk associated with the pharmaceutical development, risk associated with the Clarus financial position and those factors described under the risk factors and Clarus annual report on 10-K on the year ended December 31, 2021 filed with the Securities and Exchange Commission, the SEC on March 31, 2022 and those that are included in any of Clarus' future filings with the SEC.

這些風險和不確定性包括但不限於與藥物開發相關的風險、與 Clarus 財務狀況相關的風險，以及在截至 2021 年 12 月 31 日止年度的 Clarus 10-K 年度報告（已於 2022 年 3 月 31 日提交給美國證券交易委員會）中「風險因素」部分所述的未來因素，以及 Clarus 提交給美國證券委員會的任何因素。

These forward looking statements speaks only as the date of the call. And Clarus disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

這些前瞻性陳述僅代表截至本次電話會議發布之日的資訊。除法律另有規定外，Clarus 不承擔任何更新這些前瞻性陳述以反映此後事件或情況的意圖或義務。

Following the prepared remarks, Clarus will not be taking questions. At this time, I'd like to turn the call over to Dr. Bob Dudley, Founder, President and Chief Executive Officer of Clarus. Please go ahead, sir.

在完成事先準備好的發言後，Clarus將不再接受提問。現在，我將把電話交給Clarus的創辦人、總裁兼執行長鮑勃·達德利博士。請您發言，先生。

Thank you. Good afternoon, everyone, and thanks for joining us today. We appreciate your interest in Clarus. With me today our Chief Financial Officer, Rick Peterson; and our Chief Commercial Officer, Frank Jaeger. Now let's get started with our recent business highlights.

謝謝大家。下午好，各位，感謝各位今天蒞臨。我們非常感謝大家對Clarus的關注。今天與我一同出席的有我們的財務長里克·彼得森和首席商務官弗蘭克·耶格爾。現在，讓我們開始了解我們近期的業務亮點。

We continue to see total prescription growth for JATENZO in the first quarter of 2022 with an increase of 12% sequentially and 75% year-over-year. Driven primarily by advertising and promotion and an increase in payer coverage across all payer channels.

2022年第一季度，JATENZO的處方總量持續成長，季增12%，年增75%。這主要得益於廣告宣傳和所有支付管道覆蓋範圍的擴大。

We presented new data for JATENZO at the Androgen Society's fourth annual meeting and at the recently concluded 2022 American Urological Association annual meeting that just concluded in New Orleans.

我們在雄激素學會第四屆年會和最近在路易斯安那州新奧爾良舉行的 2022 年美國泌尿外科協會年會上展示了 JATENZO 的新數據。

We plan to submit new data to a peer-reviewed publication -- I'm sorry, peer-reviewed medical journal publication in the near future. Notably, these meetings are the first in-person medical meetings where Clarus has been able to showcase to JATENZO since the start of the COVID pandemic. And next month, we will have a significant presence at the Endocrine Society Annual Meeting in Atlanta, again, also an in-person conference.

我們計劃在不久的將來向同行評審的醫學期刊投稿。值得一提的是，這些會議是自新冠疫情爆發以來，Clarus首次能夠以線下形式向JATENZO展示其研究成果的醫學會議。下個月，我們也將隆重參加在亞特蘭大舉行的內分泌學會年會，這也是一場線下會議。

We received a notice of allowance from the U.S. Patent and Trademark Office for patent claims covering JATENZO. Once issued, we expect this will be the eighth patent for JATENZO to be listed in the U.S. Food and Drug Administration's Orange Book.

我們已收到美國專利商標局關於JATENZO專利權利要求的授權通知。一旦正式授權，我們預計這將是JATENZO第八項被列入美國食品藥物管理局橙皮書的專利。

Also on the patent front, we received a notice of allowance from the USPTO for patent claims recovery CLAR-121, a proprietary combination of testosterone plus anastrozole delivered by a subcutaneous implant for the treatment of androgen receptor mediated inflammatory breast disease that occurs predominantly in women.

此外，在專利方面，我們收到了美國專利商標局關於專利權利要求恢復 CLAR-121 的授權通知。 CLAR-121 是一種專有的睪固酮加阿那曲唑組合，透過皮下植入物輸送，用於治療主要發生在女性身上的雄激素受體介導的發炎性乳房疾病。

We've also applied for Orphan Drug designation from the FDA for CLAR-121 for the treatment of inflammatory periductal mastitis or PDM, again, a condition largely expressed in women, and we expect FDA action in June.

我們也向 FDA 申請了 CLAR-121 的孤兒藥資格認定，用於治療發炎性導管周圍乳腺炎或 PDM，這種疾病主要發生於女性，我們預計 FDA 將於 6 月做出決定。

We also announced the close of upsize $30 million underwritten public offering enabling us to continue to promote JATENZO while extending cash runway into approximately September of 2022. And finally, as noted, we continue to explore strategic alternatives to maximize stockholder value. Now Rick Peterson, our Chief Financial Officer, will discuss Clarus' financial status. Rick?

我們也宣布完成了3000萬美元的承銷公開發行，這使我們能夠繼續推廣JATENZO，同時將現金儲備延長至2022年9月左右。最後，如同先前所提到的，我們將繼續探索各種策略選擇，以最大限度地提高股東價值。現在，我們的財務長里克彼得森將討論Clarus的財務狀況。里克？

Thank you, Bob. I'll go over the first quarter '22 financial results. In summary, first quarter revenue was $4 million compared to $2.3 million in the same period last year. This represents significant growth to 72% attributed to JATENZO sales. Gross profit margin was 83% for the first quarter compared to 84% for the prior period. First quarter operating expenses were $16.9 million compared to $12.8 million in the same period last year.

謝謝鮑勃。我將介紹一下2022年第一季的財務表現。簡而言之，第一季營收為400萬美元，而去年同期為230萬美元。這代表著顯著成長，其中72%的營收成長歸功於JATENZO的銷售。第一季的毛利率為83%，而去年同期為84%。第一季的營運費用為1,690萬美元，而去年同期為1,280萬美元。

This represents an increase of 33% and driven by increased sales and marketing activity associated with the promotion of JATENZO and an increase in general and administrative expenses associated with increased headcount, partially offset by a decrease in research and development expenses. So to break that down, first quarter sales and marketing expenses were $10.7 million compared to $7.9 million in the same period last year.

這相當於增加了33%，主要原因是與JATENZO產品推廣相關的銷售和行銷活動增加，以及因員工人數增加而導致的行政管理費用增長，部分被研發費用的下降所抵消。具體而言，第一季的銷售和行銷費用為1,070萬美元，而去年同期為790萬美元。

This represents an increase of 35%, again, driven by an increase in advertising and promotional spend associated with JATENZO. General and administrative expenses were $5.3 million compared to $3.6 million in the same period last year. This represents an increase of 47% primarily attributable to higher personnel costs and costs associated with being a public company.

這相當於增加了35%，主要原因是與JATENZO相關的廣告和促銷支出增加。一般及行政費用為530萬美元，去年同期為360萬美元。這相當於成長了47%，主要原因是人員成本增加以及上市公司相關成本上升。

First quarter research and development expenses were $0.9 million compared to $1.2 million in the same period last year. This is a 27% decrease primarily attributable to just timing of clinical costs associated with JATENZO.

第一季研發費用為90萬美元，去年同期為120萬美元。這下降了27%，主要原因是與JATENZO相關的臨床成本的時間安排所致。

Our cash and cash equivalents as of March 31, '22 were $9.1 million. And then as Bob noted, we did close an upsized $30 million underwritten public offering on April 27, '22, which will fund our current operating plan into approximately September of '22.

截至2022年3月31日，我們的現金及現金等價物為910萬美元。正如鮑伯所指出的，我們於2022年4月27日完成了一筆規模擴大的3000萬美元承銷公開發行，這筆資金將用於支持我們目前的營運計劃，直至2022年9月左右。

I will now turn it over to Frank, our Chief Commercial Officer. Frank?

現在我將把發言權交給我們的首席商務官弗蘭克。弗蘭克？

Thanks, Rick. I am proud to announce that JATENZO experienced several notable milestones in the first quarter as the brand continues to grow. Total prescription growth for JATENZO in the first quarter increased 12% sequentially and 75% year-over-year, driven primarily by advertising and promotional increase in payer coverage across all payer channels. So let's dig in.

謝謝里克。我很榮幸地宣布，隨著品牌持續成長，JATENZO在第一季取得了多項顯著的里程碑成就。 JATENZO第一季的處方總量較上季成長12%，較去年同期成長75%，這主要得益於廣告和促銷活動在所有支付管道覆蓋率的提升。接下來，讓我們深入探討一下。

Specifically, our prescription growth has been driven by the following. First and foremost, we continue to receive positive feedback from health care providers and patients regarding their experience with JATENZO. Second, we are starting to see an impact of changes that are made in the fourth quarter of 2021 with our sales force.

具體而言，我們的處方量成長主要得益於以下幾點。首先，也是最重要的一點，我們持續收到醫療服務提供者和病人對JATENZO的正面回饋。其次，我們開始看到2021年第四季銷售團隊調整帶來的成效。

So recall that in the fourth quarter, we increased the number of sales representatives from 55 to 60. We optimized the sales territories to ensure that we have a national footprint, and we increased the overall TRT prescription volume coverage from 59% to approximately 80%.

回想一下，在第四季度，我們將銷售代表人數從 55 人增加到 60 人。我們優化了銷售區域，以確保我們在全國範圍內擁有業務覆蓋，並將 TRT 處方量覆蓋率從 59% 提高到約 80%。

Next, we are seeing increased health care provider access with waning COVID concerns despite Omicron's presence in the fourth quarter. So specifically, we have been able to increase sales rep access to health care provider offices. In fact, nearly 90% of all of our health care provider calls are live calls.

其次，儘管歐米克隆在第四季仍處於停滯狀態，但隨著人們對新冠疫情的擔憂逐漸消退，我們看到醫療服務提供者的訪問量增加。具體而言，我們已能夠增加銷售代表拜訪醫療服務提供者辦公室的次數。事實上，我們與醫療服務提供者的通話中，近90%都是即時通話。

Additionally, we are seeing patient visits for hypogonadism return back to normal levels, which means more patients returning to health care provider offices.

此外，我們看到因性腺功能減退症就診的患者人數已恢復正常水平，這意味著更多的患者將重返醫療機構就診。

We expect to see both health care provider access and patient visits continuing to increase throughout the year. Additionally, another important growth driver for us is our launch of 2 new strategic partnerships with Vault Health and AssistRx. Both organizations are leaders in providing health care services to patients and both underscore Clarus' continued commitment to providing solutions for patients.

我們預計全年醫療服務提供者的就診量和病患就診量都將持續成長。此外，我們與Vault Health和AssistRx建立的兩項全新策略合作夥伴關係也是推動我們成長的另一個重要因素。這兩家機構都是為患者提供醫療保健服務的領導企業，它們的合作也彰顯了Clarus致力於為患者提供解決方案的持續承諾。

Let me give you a brief overview of each. First, our partnership with Vault Health enables appropriate patients who may be suffering from hypogonadism to get clinical care from the comfort of their own home via telemedicine approach. Through our partnership, patients can access our telemedicine provider through a link on our website and by the end of the session, get a visit scheduled with a provider with appropriate lab tests being ordered.

讓我簡要介紹一下每項服務。首先，我們與Vault Health的合作使可能患有性腺功能減退症的患者能夠透過遠距醫療的方式在家中獲得臨床護理。透過這項合作，患者可以透過我們網站上的連結訪問我們的遠距醫療服務提供者，並在諮詢結束後預約醫生進行必要的實驗室檢查。

And second, our partnership is for their practice and have AssistRx do to heavy lifting for them. AssistRx integrates to health care providers EMR system. They will process the e-benefits verification, handle any prior authorizations, get patients started with JATENZO co-pay assistance and even provide a 30-day starter prescription for non-prescripts.

其次，我們的合作旨在為他們的診療實踐提供支持，讓AssistRx承擔大部分繁重的工作。 AssistRx可與醫療服務提供者的電子病歷系統整合。他們將處理電子福利驗證、辦理所有預先授權、幫助患者開始使用JATENZO共付額援助計劃，甚至提供30天的非處方藥起始處方。

And for the patient, the offering gets even better as AssistRx is in constant communication with them seamlessly filling or refilling their prescription and shipping JATENZO straight to their home plus taking a lot of the burden off of the patient's plate.

對於患者而言，AssistRx 提供的服務更加完善，因為它可以與患者保持持續溝通，無縫地填寫或續填處方，並將 JATENZO 直接送到患者家中，從而減輕患者的許多負擔。

It's important to understand that these 2 solutions work synergistically to provide better health care, provider and patient support through a white glove service model to streamline and simplify the process from getting diagnosed to putting pen to paper to getting to JATENZO.

重要的是要了解，這兩個解決方案協同作用，透過白手套服務模式提供更好的醫療保健、醫護人員和患者支持，從而簡化從診斷到填寫表格再到接受 JATENZO 治療的整個流程。

And finally, we have increased patient access to JATENZO. As for payer coverage in the first quarter of 2022, JATENZO has reached an all-time high in access and overall lives covered. For those patients who have insurance coverage in the United States JATENZO is accessible to 72% of them.

最後，我們提高了患者獲得 JATENZO 的機會。就 2022 年第一季的健保覆蓋率而言，JATENZO 的覆蓋範圍和總覆蓋率均達到了歷史新高。在美國，72% 的健保患者可以使用 JATENZO。

This represents 1 of the best-in-class branded agents with access, and the story gets even better. When you look at the commercial channel, where the bulk of the TRT prescriptions go through, we have even greater coverage there with 76% of all commercial plans now covering JATENZO.

這代表著我們擁有業界頂尖的品牌代理商之一，而且情況不止於此。在商業管道，也就是大部分睾酮替代療法處方的流通管道，我們的覆蓋範圍更廣，目前已有76%的商業保險計劃涵蓋了JATENZO。

These are significant changes over the course of the year. And now, as mentioned, JATENZO is one of the best in class. And as for patient assistance, we are seeing continued success and growth in our JATENZO co-pay assistance program. In January of 2022, we increased our annual support for out-of-pocket expenses from $2,000 to $2,400 per year.

這些都是一年來發生的重大變化。如前文所述，JATENZO 現已成為同類產品中的佼佼者。在病患援助方面，我們的 JATENZO 自付費用援助計畫也持續取得成功並不斷成長。 2022 年 1 月，我們將年度自付費用援助額度從 2,000 美元提高至 2,400 美元。

This is important as we are helping patients to an even greater extent to reduce the financial burden of co-pays and their out-of-pocket expenses for JATENZO. It should be mentioned that this is significantly different in both amount and scope as compared to the competition.

這一點至關重要，因為我們正在更大程度上幫助患者減輕使用JATENZO藥物的自付費用和共同支付費用所帶來的經濟負擔。值得一提的是，與競爭對手相比，無論在金額或範圍上，我們都存在顯著差異。

As we move forward through the rest of 2022, we believe JATENZO is poised to continue to accelerate growth. First, we expect that our overall payer coverage will continue to increase in 2022. And already in the second quarter of this year, we have seen an overall increase now to 72%. We believe that getting into the mid- to upper 70s as possible.

展望2022年剩餘時間，我們相信JATENZO將繼續加速成長。首先，我們預計2022年整體健保覆蓋率將持續提升。今年第二季度，我們的健保覆蓋率已提升至72%。我們相信，這一數字有望達到75%以上。

Second, we believe that when additional competition comes to the marketplace, it will only seek to increase the awareness and recognition for the treatment of hypogonadism and the awareness of oral therapy. We believe that this will increase our TRT market share and will raise the awareness of JATENZO as we are the only oral product that not only gets 87% of patients into the normal therapeutic range but also has dosing flexibility to allow health care providers to find the right dose that works for their patients.

其次，我們相信，當市場上出現更多競爭者時，只會促使人們更加關注性腺功能減退症的治療以及口服療法。我們相信，這將提升我們的睪固酮替代療法（TRT）市場份額，並提高JATENZO的知名度，因為我們是唯一一款不僅能使87%的患者達到正常治療範圍，而且劑量靈活，便於醫護人員找到適合患者的劑量的口服產品。

To be clear, with JATENZO, health care providers can go up or down on their treatment dose to dial in the exact therapy that a patient needs. Next, we expect the TRT market will continue to grow even larger. Currently, the market is about over 8.1 million prescriptions with over 2.2 million appropriate patients getting treated.

需要明確的是，借助 JATENZO，醫療服務提供者可以根據患者的具體情況調整治療劑量，從而實現精準的治療。接下來，我們預期睪固酮替代療法 (TRT) 市場將持續成長，規模進一步擴大。目前，該市場處方量已超過 810 萬張，超過 220 萬名符合條件的患者正在接受治療。

These patients represent a key opportunity for JATENZO as these patients are currently on therapies that are associated with administrative challenges. And JATENZO is as straightforward as taking a medication with 2 meals per day. Specifically, as I mentioned on our previous earnings call, we know that an independent survey study that we did in over 400 hypogonadal men that nearly 8 out of 10 patients are not satisfied with their current nonoral therapies.

這些患者對 JATENZO 而言是一個重要的機遇，因為他們目前接受的治療方案在管理上有許多挑戰。而 JATENZO 的使用方法非常簡單，只需每日隨餐服用兩次即可。具體而言，正如我在先前的財報電話會議上提到的，我們開展了一項針對 400 多名性腺功能減退男性患者的獨立調查研究，結果顯示，近 80% 的患者對他們目前使用的非口服療法並不滿意。

We also know that JATENZO overcomes those administration issues as an oral. In fact, 82% of the patients, if they knew an oral existed, would want to learn more and would ask their doctor about JATENZO.

我們也知道，口服的JATENZO克服了這些給藥方面的難題。事實上，82%的患者如果知道有口服的JATENZO，會想要了解更多信息，並會向醫生諮詢。

And finally, we know that physicians would nearly always switch a patient to JATENZO if the patient requested the switch. Even if the patient was therapeutic on their current product that was not experiencing side effects.

最後，我們知道，如果病人要求換藥，醫生幾乎總是會將病人換成 JATENZO。即使患者目前使用的藥物療效良好且沒有副作用。

We have finalized our new integrated health care provider and consumer promotional campaign and have a focused consumer media plan in place to address and raise awareness of JATENZO to these targeted patients through vehicles like paid search, display advertising and through social channels like Facebook, Instagram and YouTube.

我們已經完成了新的綜合醫療保健提供者和消費者推廣活動，並製定了有針對性的消費者媒體計劃，透過付費搜尋、展示廣告以及 Facebook、Instagram 和 YouTube 等社交管道，向這些目標患者宣傳和提高對 JATENZO 的認識。

And finally, we know that there is additional opportunity with the greater than 4 million patients who have either been diagnosed or have stopped treatment. These patients are ideal candidates for JATENZO as many patients stop therapy due to product-specific issues. And as an oral, we believe that JATENZO may be an option for many of those patients.

最後，我們知道，超過400萬名已確診或停止治療的患者也蘊藏著巨大的機會。這些患者是JATENZO的理想候選者，因為許多患者因產品本身的問題而停止治療。作為一種口服藥物，我們相信JATENZO可能為其中許多患者提供一種新的選擇。

Besides the consumer media plan that I just mentioned, we are finalizing the production of the DTC TV commercial and plan to launch that DTC component in the coming months to target the appropriate hypogonadal diagnosed and currently or previously treated patients. We currently expect that this is going to be a significant driver of JATENZO's growth in the future.

除了我剛才提到的消費者媒體計劃之外，我們正在敲定面向消費者的電視廣告的製作，併計劃在未來幾個月內推出該廣告，目標受眾為已確診或正在接受治療的性腺功能減退症患者。我們預計這將成為未來推動JATENZO成長的重要動力。

So as I close, I want to reemphasize that we are excited about the impact we're having in the market today with our current initiatives and those that we have in place, and we're excited about what lies ahead for us on the horizon. And now I'll turn it back over to Bob. Bob?

最後，我想再次強調，我們對目前以及已經實施的各項措施在市場上產生的影響感到非常興奮，也對未來的發展前景充滿期待。現在，我把麥克風交還給鮑伯。鮑伯？

Thank you, Mike. Let's talk a little bit about recent pipeline highlights and some updates around where we are headed from a pipeline perspective. With respect to JATENZO, we announced the initiation of screening for first patient and an investigator-initiated Phase IV clinical trial of JATENZO for the treatment of hypogonadal men with chronic kidney disease in March. We expect to announce the results of this trial in the first half of 2023.

謝謝，麥克。我們來聊聊近期研發管線的亮點以及我們未來的研發方向。關於JATENZO，我們在3月份宣布啟動首例患者的篩選，並啟動一項研究者發起的針對慢性腎病合併性腺功能減退男性患者的JATENZO IV期臨床試驗。我們預計在2023年上半年公佈該試驗的結果。

And we continue to work on several label expansion, life cycle management projects also for JATENZO and all with potentially large markets. These include key therapy for female to male transgender individuals or trans males and another -- which would be another investigator-initiated label expansion study that we anticipate starting as a Phase IV study in the second half of 2022.

我們持續推進JATENZO的多個適應症擴展和生命週期管理項目，這些項目都具有巨大的潛在市場。其中包括針對女性變男性跨性別者或跨性別男性的關鍵療法，以及另一項研究者發起的適應症擴展研究——我們預計將於2022年下半年啟動研究的IV期臨床試驗。

As mentioned before, we still believe that there is the potential for a once-daily oral TU product, and we are looking at potential Phase II initiation in the second half of this year also subject to availability of funding.

如前所述，我們仍然相信每日一次口服TU產品具有潛力，我們正在考慮在今年下半年啟動II期臨床試驗，但這取決於資金的到位情況。

Regarding the R&D pipeline, we continue to advance both the CLAR-121 and the 222 projects. The CLAR-121, as a reminder, a combination of testosterone plus anastrozole. We license from HavaH Therapeutics in Australia for the treatment of inflammatory breast disease, most notably periductal mastitis and has potential adjunctive therapy in estrogen-positive androgen receptor positive breast cancer.

在研發管線方面，我們正持續推動CLAR-121和222兩個專案。 CLAR-121是一種睪固酮合併阿那曲唑的藥物。我們從澳洲HavaH Therapeutics公司獲得授權，用於治療發炎性乳腺疾病，尤其是導管周圍乳腺炎，且該藥物在雌激素受體陽性、雄性素受體陽性的乳癌中具有潛在的輔助治療價值。

We project an initiation of a Phase II study for PDM in the late second half of 2022, again, subject to availability of funding. With respect to CLAR-222, this is the combination of CoQ10 or ubiquinone plus caspofungin. We in-licensed this technology from McGill University in September. We project initiation of Phase I treatment for primary and secondary forms of CoQ10 deficiency and related mitochondrial dysfunction in the second half of 2022, again, both of these projects, both for PDM and for CoQ10 deficiency subject to availability of funding.

我們預計2022年下半年末啟動PDM的II期臨床試驗，但前提是資金到位。關於CLAR-222，它是輔酶Q10或泛醌與卡泊芬淨的聯合療法。我們於9月份從麥吉爾大學獲得了這項技術的許可。我們預計2022年下半年啟動原發性和繼發性輔酶Q10缺乏症及相關粒線體功能障礙的I期臨床試驗，同樣，這兩個計畫（包括PDM和輔酶Q10缺乏症）的啟動都取決於資金到位情況。

Relative to intellectual property highlights for JATENZO. As of the first quarter, we had a total of 7 Orange Book listed patents in the Orange Book for JATENZO providing coverage to 2030. In April, we announced that the USPTO had issued an important notice of allowance covering additional claims for JATENZO. Once issued, we anticipate this patent will be listed in the FDA's Orange Book as well, thus bringing the total number of Orange Book listed patents to 8.

關於JATENZO的知識產權亮點。截至第一季度，我們共有7項JATENZO專利被列入美國食品藥物管理局（FDA）的《橙皮書》，專利保護期至2030年。 4月份，我們宣布美國專利商標局（USPTO）已發布一項重要的授權通知，涵蓋JATENZO的額外權利要求。該授權通知發布後，我們預計該專利也將列入FDA的《橙皮書》，屆時JATENZO在《橙皮書》中列出的專利總數將達到8項。

For CLAR-121, this is the combination of testosterone plus anastrozole. Last week, we announced the USPTO issued a notice of allowance covering claims for CLAR-121. And we have an active Orphan Drug designation application under review by FDA for the treatment of periductal mastitis, and we expect a response in the second quarter of this year.

CLAR-121是睪固酮和阿那曲唑的組合。上週，我們宣布美國專利商標局已發布授權通知，涵蓋CLAR-121的權利要求。此外，我們已向美國食品藥物管理局（FDA）提交了治療乳腺導管周圍炎的孤兒藥資格認定申請，目前正在審核中，預計將於今年第二季收到回覆。

As noted in my earlier remarks, we have been active in attending medical conferences. Happily, all of these have been in person this year, starting with the Androgen Society in April in Orlando, the AUA that just completed in New Orleans, well attended, and we had a significant interest there. We will be also presenting abstracts and have a booth at the Endocrine Society Annual Meeting live in Atlanta, June 11 to the 14.

正如我之前提到的，我們一直積極參與醫學會議。令人欣喜的是，今年的所有會議都以線下形式舉辦，包括四月份在奧蘭多舉行的雄激素學會年會，以及剛剛在新奧爾良落幕的美國泌尿外科協會年會（AUA），該年會參會人數眾多，我們也對此表現出了濃厚的興趣。此外，我們也將在6月11日至14日於亞特蘭大舉行的內分泌學會年會上提交摘要並設立展位。

As we close, I just want to give my sincere thanks to Team Clarus. We are lean and mean and work very hard for all of our efforts towards JATENZO and our shareholders. We also thank our external partners for their hard work on our behalf, and we thank our shareholders and our directors for their support. We are excited about our future and look forward to providing continued positive news in the second quarter.

最後，我要衷心感謝Clarus團隊。我們精簡高效，為了JATENZO和我們的股東，我們付出了巨大的努力。我們也要感謝外部合作夥伴為我們所做的辛勤工作，以及股東和董事們的支持。我們對未來充滿信心，並期待在第二季度繼續為大家帶來正面的消息。

And with that, this call will end after the operator has final comments. Thank you.

通話到此結束，接線員作完最後說明。謝謝。

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

今天的電話會議到此結束。您可以掛斷電話了。