Jaguar Health Inc (JAGX) 2022 Q3 法說會逐字稿

Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to the matters as contained growth prospects for the company, uncertainties regarding market acceptance of products, the impact of competitive products and pricing, industry trends and product initiatives, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements. Fast -- forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes its assumptions, expectations and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and the Risk Factors sections of the company's Form 10-K for the year 2021, which was filed March 11, 2022, and its other filings with the SEC, which are available on the Investor Relations section of Jaguar (inaudible). Expect as required by law, JAG undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, further events or otherwise. Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects (inaudible) basis upon the company management assesses and operates the business. These non-GAAP financial measures should not be viewed in isolation or a substitute for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance and conformity with GAAP. Today's conference is being recorded. And at this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health Founder, President and Chief Executive Officer. Please, the floor is yours.

在我將電話轉交給管理層之前，我想提醒您，管理層可能會就公司的增長前景、產品市場接受度的不確定性、競爭產品的影響和定價等事項做出前瞻性陳述、行業趨勢和產品計劃，包括處於開發階段的產品，這些產品可能無法實現科學目標或滿足嚴格的監管要求。快速——前瞻性陳述受風險和不確定性的影響，這些風險和不確定性可能導致實際結果與此類前瞻性陳述中預期的結果存在重大差異。這些陳述基於當前可獲得的信息和管理層對未來事件的當前假設、預期和預測。雖然管理層認為其假設、預期和預測根據當前可用信息是合理的，但請注意不要過分依賴這些前瞻性陳述。由於各種原因，公司的實際結果可能與本次網絡廣播中討論的結果存在重大差異，包括前瞻性陳述和公司 2021 年 10-K 表格風險因素部分中描述的那些，該表格於 3 月 11 日提交, 2022，以及它向美國證券交易委員會提交的其他文件，可在 Jaguar 的投資者關係部分獲得（聽不清）。除法律要求外，JAG 不承擔更新或修改本演示文稿中包含的任何前瞻性陳述以反映新信息、進一步事件或其他情況的義務。此外，請注意，公司通過提供非 GAAP EBITDA 和非 GAAP 經常性 EBITDA 來補充其按 GAAP 編制的簡明合併財務報表。捷豹認為，這些非 GAAP 措施的披露項目為投資者提供了反映（聽不清）公司管理層評估和經營業務的基礎的額外信息。這些非 GAAP 財務措施不應孤立地看待或替代 GAAP 淨銷售額和 GAAP 淨虧損，也不能替代或優於衡量財務業績和符合 GAAP 的措施。今天的會議正在錄製中。此時，我很高興將電話轉給 Jaguar Health 創始人、總裁兼首席執行官 Lisa Conte。地板是你的。

Thank you very much, and thank you for those comprehensive forward-looking statements. Welcome all. As you just heard, my name is Lisa Conte, and I am the founder, President and CEO of Jaguar Health and our wholly owned subsidiary in the United States, Napo Pharmaceuticals. And for those of you who can only participate for a short time here are the key takeaway messages from this webcast regarding upcoming potential momentum drivers. Combined net revenue for our prescription products increased in the third quarter of 2022 for the fifth quarter in a row, growing 8.2% in Q3 versus Q2 of 2022 and increasing approximately 412% over Q3 2021. Next, we expect the successful completion of our ongoing Phase III on-target clinical trial of crofelemer for cancer therapy-related diarrhea to potentially expand the indication of Mytesi, with enrollment in the trial targeted for completion in the second quarter of 2023, with an analogous market opportunity in chemotherapy-induced nausea vomiting of approximately $3 billion for comparison purposes. As we recently announced, the full results of the investigator-initiated HALT-D trial named HALT-D, evaluating crofelemer for preventing chemotherapy-induced diarrhea in breast cancer patients was published last month in the peer-reviewed journal breast cancer research and treatment, the principal investigator and author of that was Dr. Sandy Swain, who's the former President of ASCO. Next point, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology division at the Sheikh Khalifa Medical City in Abu Dhabi in the UAE, is leading an investigator-initiated proof-of-concept trial of crofelemer for short bowl syndrome, which you may hear us refer to in this discussion as SBS and also congenital diarrheal disorders, which we may refer to as CDD. Publication of proof-of-concept data from this and other expected investigator-initiated trials could support early patient access to crofelemer for SBS and/or CDD with intestinal failure within 2023 through programs in Europe. These early patient access programs, which do not exist in the United States, are revenue generating and reimbursable for participating patients and focused on rare diseases where there are no good alternative treatments. Next, we expect that a business development deal will be executed in the next couple of months that will bring in non-dilutive funding in support of our mental health and Theragene therapeutics initiative program and our extensive proprietary library of plants and plant extracts, which is an asset we're looking to mobilize. -- and finally, a second conditional approval for Canalevia for exercise-induced diarrhea, which we refer to as EID in dogs is targeted for the first quarter of 2023, complementing Canalevia, which is currently conditionally approved for chemotherapy-induced diarrhea in dogs. And now I'll go into greater detail on these bullet point items. I'm going to begin today with the key top line results for the third quarter, the financial results for the third quarter of 2022. Prescription product net revenue totaled approximately $3.1 million. This is in the third quarter of 2022. And as I mentioned, this represents an 8.2% increase over the second quarter of 2022 and an increase of approximately 41% and over the third quarter of last year, 2021. And this is the fifth consecutive quarter of growth in Mytesi net revenue. We are quite pleased with the growth trajectory of our current prescription drug business. And as you'll hear, quite excited about the late-stage pipeline opportunities that we feel will be transformative in value recognition, value creation for all our stakeholders, including, of course, patients and our shareholders. I'll continue with a few other updates and then Carol Lizak, our Chief Financial Officer, will provide a recap of the key financial results for the third quarter of 2022. And after Carol speaks, we'll hear from Ian Wendt Jaguar's Chief Commercial Officer. Ian will speak to updates on Mytesi-related commercial initiatives to continue to educate and serve the HIV community and about ongoing commercial efforts underway for Canalevia CA1, our prescription product for the treatment of chemotherapy-induced diarrhea in dogs. We call that sometimes CID. And this product has been conditionally approved by the FDA and became commercially available just this year to veterinarians in April of 2022 and for dog owners to provide comfort and relief to their family members into the canine patients. As a reminder, our commercialized drug product is named Mytesi. The generic name is Crofelemer, -- it is a first-in-class antisecretory agent approved initially in the United States for the specialty indication of symptomatic relief of noninfectious diarrhea in adult patients with HIV AIDS on antiretroviral therapy (inaudible). As the term specialty implies, this is a relatively small market, an important market, but the HIV market is relatively small. The indication was fast-tracked by the FDA. And that's why it's the first approved indication for Crofelemer. As I frequently state, what is really powerful about proper is that it is a pipeline within a product. And what I'm going to focus on today are the 2 late-stage clinical milestones, what we believe are potentially transformative events in the next approximately 6 to 9 months in support of the company taking Crofelemer from pipeline opportunities to with the potential of important and significant clinical trial results, tangible revenue-generating patient benefiting product indications. The core human follow-on indications on which we are focused are cancer therapy-related diarrhea, CTD, in the United States. -- and through Napo's Therapeutics rare disease business model, a company that we established in Italy, the orphaned indications of SBS or Balasingam and CDD congenital diarrheal disorders, initially for commercialization in Europe. However, with clinical data, both generated in the U.S. and available for U.S. filings as well. So first, what exactly are these indications? Each year, according to the CDC, there's more than 1 million cancer patients in the United States receiving chemotherapy or radiation in an outpatient oncology clinic in the United States and as many as 50% to 100% of these patients experienced diarrhea depending on the treatment regimen. Most of us have had lives of our close community touching by cancer in some way. There have been amazing advances to treat survivors to make survivors, not managing diarrhea, negatively impacts patient outcomes of their cancer therapy as approximately 40% of cancer treatment patients who experience diarrhea, either discontinue their life-saving cancer therapy or move to or even start with a subtherapeutic dose of their cancer treatment regimen. This is at best, highly distressing and impacts the comfort and dignity of the patient and at its worst it impacts the outcome of the patient's chemotherapy and drives cost to the health care system from immense dehydration, potential infections, compromised outcomes for the cancer treatment. Enrollment is continuing for the on-target study that is the name of our pivotal Phase III trial of crofelemer for cancer therapeutic dated diarrhea in humans. We're aiming to complete this enrollment with a total of 256 patients by the second quarter of 2023, just around the corner. This is a prophylaxis study, which tells you a lot about how important it is to get in front of the impact of diarrhea during cancer treatment. CTD is not the mild loss of control that we've all invariably experienced with perhaps a minor flu or a bad meal. This is diarrhea that can put patients in the hospital can cause organ shutdown. -- and has even contributed to death in some patients who have been in targeted cancer agent manufacturers clinical trials. With the new targeted therapies, cancer therapies that are used chronically, both in metastatic and in curative cancer situation, therapies are used for months or years. The incidence of diarrhea is sometimes as high as 100% to project the potential market opportunity for CTD since crofelemer would be the first drug to be approved for this indication, we're looking at an analogous market, chemotherapy-induced nausea and vomiting, CINV, how it's often referred to, which is projected to be close to a $3 billion global market this year according to a report published by Allied Market Research, and CINV agents are typically only used for about the first 3 to 5 days in traditional cytotoxic chemotherapy, and there are many generic entries in this market. With CTD, cancer therapy-related diarrhea, we are talking about diarrhea that can persist on a chronic basis for months or years. The enrollment criteria for our Phase III trial includes all patients with solid tumors -- so a basket approval, a broad approval, including a label for prophylaxis for patients on target therapy with or without cytotoxic chemotherapy in all solid tumors is the label expansion we are seeking for Mytesi. And let me point out, this trial is being done with the exact formulation of Mytesi, which is already proved, which obviously has a full GMP compliant supply chain in place and is approved for chronic indication. So has chronic safety completed as well. The 2 most common reasons safety manufacturing why new drug applications fail are already taken care of with Mytesi. We're very excited about this program with (inaudible) strong safety profile, we expect cancer patients to be able to tolerate and benefit from Crofelemer chronically. The successful completion of enrollment in our on-target pivotal trial, again, just around the corner targeted for the second quarter of 2023. Well, we expect lead to a supplemental new drug application filing for Mytesi, as I mentioned, the same formulation of crofelemer that is currently approved. We spent much care and engaged in extensive communication with the FDA in the design and the execution of this final clinical and regulatory step to support bringing crofelemer to cancer patients suffering from diarrhea and/or the risk of diarrhea from their prescribed therapy. I'll now discuss our prioritized or bowl syndrome pipeline indication for crofelemer. I am Chairman of the Board of Napo Therapeutics, the corporation we established in Milan, Italy last year to which we granted an exclusive license to Crofelemer in Europe. Specifically, Napo Fera is initially pursuing a rare disease business model based on the orphan drug designation of crofelemer for SBS and CDD with intestinal failure, Jaguar is a majority shareholder of Napo Therapeutics as well as the licensor of the technology, which, therefore, provides equity interest value to Jaguar as well as typical license terms. Let me describe the catastrophic medical situation for people with SBS (inaudible) syndrome. A normal gut is 20, 25 feet in length. In SBS, the patients could be less than 5 feet for congenital reasons or as a result of surgery due to cancer, inflammation or an accident. As you can imagine, with a very short gut, it's like a (inaudible), what goes in comes right out. The bottom line is that there's not enough intestinal real estate surface area for the SBS patient to absorb the nutrients of life, carbohydrates, protein fats, vitamins and minerals. So what happens is that these patients often end up on parenteral nutrition, the intravenous feeding of liquid nutrients for up to 20 hours a day, 7 days a week. Obviously, a significant negative impact on the patient's quality of life, and there are multiple negative health impacts, infections, complications associated with parenteral nutrition. It's expensive. It costs hundreds of thousands to millions to $1 million a year to manage an individual patient, including not only the price of nutrition, but also the myriad of complications with very high morbidity and mortality. The global market for SBS is projected by third parties to reach $5 billion by 2027. This is a report from Vision Research reports. Although French nutrition is considered the standard of care, there is a drug product approved for SBS (inaudible)teduglutide, very hard to pronounce teduglutide, which is a GLP-2 analog. It's essentially a growth hormone, intended to grow the surface, the real estate of the gut slightly so that there is a little bit more time for absorption. It's administered as an injection, and it's estimated to be utilized in less than 10% of the SBS patient population is not considered standard of care. And GLP-2 analogs have a range of side effects, including cardiovascular risk, endocrine risk, and it's not used chronically. The primary endpoint in the trial for the approval of teduglutide was the reduction in the time required to be on printer nutrition by about 20%. What we're looking to do with Crofelemer for a primary endpoint is to reduce the time on parenteral nutrition as well and provide better stool formation and a quality of life measurement, which the reimbursement organizations have indicated is important to them. As I mentioned, SBS development of crofelemer is being pursued through Napo Therapeutics in Europe, which holds an exclusive license to Crofelemer for the European marketplace from Jaguar. Jaguar is licensor, Napa Therapeutics as a licensee. And it's a classic license agreement, incorporating upfront payment milestones and royalties. We based the new company in Europe because key countries in the European Union and Europe, U.K., which is not the European Union, have early access programs for orphan indications with unmet medical needs like SBS, because of the impact on patients. Early patient access programs of this type do not exist currently in the United States. Hence, with published proof-of-concept data, patients in specific major markets in Europe and get access to a product through these early access programs, while the full approval trials are still being pursued. Early access programs are revenue generating and for participating patients, the product is reimbursed. We have approved an investigator-initiated proof of post trial for feline 4 SBS in CDD. The third-party investigator is targeting a presentation of this trial at next month's December 2022 next month's World Congress of gastroenterology. This is a global GI conference in Dubai. Additional investigator-initiated requests and trials and clinical data are expected to come throughout 2023 from key opinion leaders with whom we've been in touch. And in accordance with the guidelines of specific EU countries, as I mentioned, publications of such data could support early patient access to Crofelma for SBS or CDD with intestinal failure within 2023. -- as Jaguar and Napo Therapeutics were pleased to announce last month the European Medicines Agency, which is the equivalent of the FDA in the United States, EMA is in Europe. The granted orphan drug designation for crofelemer for the indication of microvelus inclusion disease, MVID. This is a rare congenital disorder, so it's a form of CDD. And this -- it was granted in the European Union. This is a very welcome development for crofelemer because now it is a new molecular entity that has been granted to orphan designations by the EMA in less than 1 year. The orphan designation for SBS was received from the EMA in December of 2021. This regulatory progress for the molecule is absolutely remarkable. Crofelemer already holds orphan drug designation in the United States for SBS. And this is a classic rare disease estimated about 40,000 people around the world. Again, remember, third-party market research put the market opportunity at $5 billion for rare disease is about 40,000 given the way reimbursement works for rare disease business models. MVID, which, as I said, is a component of CDD is ultrarare with maybe only a couple of hundred of infants around the world. The orphan drug designation application for crofelemer for MVID was also submitted to the FDA in the United States, and we're standing by waiting for that designation. -- financially important key advantage of Napo therapeutics effort to Jaguar is that Napo (inaudible) is well over majority owned by Jaguar, providing potential equity value accretion to Jaguar shareholders and stakeholders value that we believe is unrecognized at this time. Jaguar also receives the value of any clinical data generated by Napofhera and recyclicaly, Napothera receives the value and ability to utilize, for example, the CTD, the cancer Phase III data Jaguar is developing for their licensed territory in Europe. Hence, the parallel complementary and geographically focused development efforts of Crofelemer for these 3 core indications, CTD, SBS and CDD are progressing simultaneously and collaboratively with 2 dedicated focus and extremely experienced and talented teams for the relevant pursuits on each side of the ocean. So to recap, in approximately 6 to 9 months, we expect to have completion of enrollment in our Phase III trial of cancer therapy-related diarrhea, called the ON TARGET trial and published proof-of-concept data in support of potential early access program participation in mid-2023 in Europe for SBS and/or CDD, which could bring in meaningful revenues, while Crofelemer continues to go through the process for full approval in Europe, 2 expected transformative events on the near-term horizon, supporting value recognition, potentially moving initiatives from a pipeline opportunity to ultimately tangible revenues, further tangible revenues in hand for Crofelemer An additional key milestone for 2022 on the human front, for which we completed in the third quarter of this year was the filing of an investigational new drug application with the FDA for our NP300 drug candidate for the symptomatic relief of diarrhea from (inaudible). We were very pleased to hear from the FDA in September that they completed their review of our IND and concluded that Jaguar may proceed with its proposed Phase I clinical trial for the drug. And we are grateful for the partial financial support we received from the National Institute of Allergy and Infectious Diseases to support the NP300 preclinical program. Following the completion of Phase I trial, we are positioned to initiate the next stage of clinical development program for (inaudible), -- when Jaguar has the requisite resources and bandwidth to initiate these additional trials. We intend to pursue a tropical disease priority review voucher to develop NP300 for the (inaudible) indication under the FDA's financial incentive program. Priority review vouchers are transferable. And in past transactions by other companies, has sold for values ranging from $67 million to $350 million, which provides for a potential immediate return on investment upon approval of NP300 for the color-related diarrhea indication and receipt of a priority review voucher. And now if we move on to our Animal Health side of the business, which is a relatively small side of our business, but very important and meaningful. Crofelemer is also the active ingredient in Canalevia CA1, our product for chemotherapy-induced diarrhea in dogs for which commercial launch activities have already been initiated and ongoing throughout 2022. The entire cancer situation does is remarkably analogous to the human situation. And as with humans, it's estimated that dogs discontinue their disease-modifying chemotherapy or move to a subtherapeutic dose nearly 40% of the times due to diarrhea, meaning that these dogs cannot complete their therapeutic dose of chemotherapy because of diarrhea. The comfort of the dog is one of the most important, if not the most important considerations of dog owners when they decide whether or not to put their dog. -- through cancer treatment. As you can imagine, you can't speak to the dog and also the entire household when is compromised when the dog has lost control. There are a couple of really important factors in the dog market. The incidence of cancer in dogs is reported to be 5x what we see in humans. And the total number of dogs in the U.S. is about $108 million post pandemic, $108 million. And unfortunately, and heart-breakingly, about 50% of the dogs over the age of 10 are going to be diagnosed with cancer at some point. So in addition to this really important conditionally approved indication of CID chemotherapy-induced diarrhea in dogs. Crofelemer is expected to be conditionally approved for the treatment of exercise-induced diarrhea in dogs in the first quarter of 2023. Jaguar also is proud to say that we launched the first ever canine cancer registry in the United States in May of this year. At an event in New York, we couldn't believe that of registry did not exist in the United States. The project is called the Jaguar Health take charge as an acronym initiative. The goal in establishing take charge is to assess the prevalence and insulin incidence of cancer in dogs and most importantly, how you can keep the dog and the entire family situation comfortable during what is often a very siloed and tragic event for family and help create a community of support and education with the information that comes from the registry. The take charge campaign was developed by (inaudible), which is Jaguar's amazing PR firm and one of the financial cosponsors of take charge. And (inaudible) efforts have led to more than 80 million media impressions generated for the for take charge with more to come, of course. And I'm happy to report that just this month, the Marcom Awards program, which celebrates excellence in marketing and communication honored take charge with 2 platinum or awards and 1 gold award, which drives awareness and therefore, the value of the registry, and we're quite proud of (inaudible) runs capabilities and efforts there. In the next 12 months, there is the potential for a lot of other news. And in particular, on the business development front, we have global rights to crofelemer for all indications. For what I'm going to focus on, though, beyond our GI efforts is Jaguar's mental health focus development efforts, which is called Entheogen Therapeutics Initiative, ETI. And this initiative aims to discover and develop groundbreaking novel natural medicines derived from the psychedelic and psychoactive plants for the potential treatment and potentially cure of mental health disorders. This effort has been designed to mobilize a key Jaguar asset, our proprietary library of 2,300 plants and 3,500 plant extracts that was generated over 3 decades. In June of this year, Jaguar and Filament Health find a letter of intent to enter a collaboration agreement to develop botanical prescription drugs for specific psychoactive target indications in the United States. Filament has laboratories, manufacturing, manufacturing IP capability for natural and plant priced products that Jaguar as a company now focused on later-stage clinical development no longer has. We bring to the table the ethnobotany expertise of how to do drug development under FDA botanical guidance, which is the approval that we have for Mytesi. And our 2 companies together are seeking partnerships with well-funded entities to pursue regulatory approval and ultimately, commercialization for novel pharmaceutical prescription grade plant-based standardized drug candidates in the mental health space. Jaguar in filament together are far along in discussions. And within the next several months, I believe you can expect to see a formalized business development collaboration that involves bringing in nondilutive funding to help mobilize and leverage Jaguar's plant library for the very important initial targets, we're thinking of ADHD and social anxiety disorder, 2 markets that have understandably expanded because of the pandemic. I believe you can also expect to see other business development deals on the horizon because we are committed. It is our mission to bring crofelemer to all patient populations in need in all geographies around the world. Finally, I'd like to let all of you participating today know that we will have a brief Q&A segment at the end of the webcast to address any questions if they are submitted in writing. Questions can be submitted via the webcast link for today's event that appears on the Events and Presentations page of the Investor Relations section of Jaguar's website and the URL for Jaguar's website is jaguar.health. We'll now move along to the key financial results for the third quarter of 2022. Carol, our CFO. I'll turn it over to you.

非常感謝，也感謝您所做的全面的前瞻性陳述。歡迎大家。正如你們剛剛聽到的，我叫麗莎·康特，是 Jaguar Health 和我們在美國的全資子公司 Napo Pharmaceuticals 的創始人、總裁兼首席執行官。對於那些只能短時間參與的人來說，這裡是本次網絡廣播中關於即將到來的潛在動力驅動因素的關鍵要點信息。我們處方產品的合併淨收入在 2022 年第三季度連續第五個季度增長，第三季度比 2022 年第二季度增長 8.2%，比 2021 年第三季度增長約 412%。接下來，我們預計成功完成我們正在進行的Crofelemer 治療癌症治療相關性腹瀉的 III 期靶向臨床試驗可能會擴大 Mytesi 的適應症，試驗的招募目標是在 2023 年第二季度完成，在化療引起的噁心嘔吐方面有類似的市場機會大約 30 億美元用於比較。正如我們最近宣布的那樣，研究人員發起的名為 HALT-D 的 HALT-D 試驗的全部結果已於上個月在同行評審的乳腺癌研究和治療雜誌上發表，該試驗評估了 crofelemer 對預防乳腺癌患者化療引起的腹瀉的作用，主要研究者和作者是 Sandy Swain 博士，他是 ASCO 的前任主席。接下來，阿聯酋阿布扎比謝赫哈利法醫療城小兒胃腸病科主任 Mohamad Miqdady 博士正在領導一項由研究者發起的 crofelemer 治療短碗綜合徵的概念驗證試驗，您可以請聽我們在本次討論中將其稱為 SBS 以及先天性腹瀉病，我們可能將其稱為 CDD。來自該試驗和其他預期的研究者發起的試驗的概念驗證數據的發布可以支持患者在 2023 年內通過歐洲項目及早獲得 crofelemer 治療 SBS 和/或 CDD 伴腸衰竭。這些在美國不存在的早期患者參與計劃可為參與的患者創收和報銷，並專注於沒有好的替代療法的罕見疾病。接下來，我們預計將在未來幾個月內執行一項業務發展交易，該交易將帶來非稀釋性資金，以支持我們的心理健康和 Theragene 治療計劃以及我們廣泛的植物和植物提取物專有圖書館，這是我們正在尋求動員的資產。 -- 最後，第二次有條件批准 Canalevia 治療運動引起的腹瀉，我們稱之為狗的 EID，目標是在 2023 年第一季度，以補充 Canalevia，後者目前有條件地批准用於狗的化療引起的腹瀉。現在我將更詳細地介紹這些要點項目。今天我將從第三季度的關鍵頂線結果開始，即 2022 年第三季度的財務結果。處方產品淨收入總計約為 310 萬美元。這是在 2022 年第三季度。正如我提到的，這比 2022 年第二季度增長了 8.2%，比去年第三季度 2021 年增長了約 41%。這是連續第五個季度Mytesi 淨收入的季度增長。我們對目前處方藥業務的增長軌跡感到非常滿意。正如您將聽到的那樣，我們對後期管道機會感到非常興奮，我們認為這些機會將在價值識別和為我們所有利益相關者創造價值方面發生變革，當然包括患者和我們的股東。我將繼續介紹其他一些更新，然後我們的首席財務官 Carol Lizak 將回顧 2022 年第三季度的主要財務業績。Carol 發言後，我們將聽取 Ian Wendt Jaguar 首席商務官的發言官。 Ian 將介紹與 Mytesi 相關的商業舉措的最新情況，以繼續教育和服務 HIV 社區，以及正在進行的 Canalevia CA1 商業活動，這是我們用於治療狗化療引起的腹瀉的處方產品。我們有時稱其為 CID。該產品已獲得 FDA 的有條件批准，並於今年 2022 年 4 月上市銷售給獸醫，並讓狗主人為他們的家庭成員提供舒適和安心。提醒一下，我們的商業化藥品名為 Mytesi。通用名稱是 Crofelemer，它是一種一流的抗分泌劑，最初在美國獲得批准，用於緩解接受抗逆轉錄病毒治療的成年 HIV AIDS 患者非感染性腹瀉的症狀（聽不清）。正如專業一詞所暗示的那樣，這是一個相對較小的市場，一個重要的市場，但艾滋病毒市場相對較小。該適應症由 FDA 快速跟踪。這就是為什麼它是 Crofelemer 的第一個獲批適應症。正如我經常說的，proper 真正強大的地方在於它是產品中的管道。我今天要重點關注的是 2 個後期臨床里程碑，我們認為在接下來的大約 6 到 9 個月內可能會發生變革性事件，以支持公司將 Crofelemer 從管道機會轉變為具有重要潛力的產品和重要的臨床試驗結果，有形的創收患者受益的產品適應症。我們關注的核心人類後續適應症是美國的癌症治療相關性腹瀉 (CTD)。 ——通過我們在意大利成立的 Napo's Therapeutics 罕見病商業模式，SBS 或 Balasingam 和 CDD 先天性腹瀉病的孤兒適應症，最初在歐洲進行商業化。但是，臨床數據均在美國生成，也可用於美國備案。那麼首先，這些跡像到底是什麼？根據疾病預防控制中心的數據，美國每年有超過 100 萬癌症患者在美國的腫瘤門診接受化療或放療，其中多達 50% 至 100% 的患者因治療而出現腹瀉療程。我們中的大多數人在我們親密社區的生活中都以某種方式接觸過癌症。在治療倖存者方面取得了驚人的進步，使倖存者成為倖存者，而不是控制腹瀉，這對患者的癌症治療結果產生了負面影響，因為大約 40% 的患有腹瀉的癌症治療患者要么停止挽救生命的癌症治療，要么轉向甚至開始治療使用亞治療劑量的癌症治療方案。這充其量是非常痛苦的，會影響患者的舒適度和尊嚴，而在最壞的情況下，它會影響患者化療的結果，並因嚴重脫水、潛在感染、癌症治療結果受損而增加醫療保健系統的成本。靶向研究的招募仍在繼續，這是我們 crofelemer 用於人類癌症治療性腹瀉的關鍵 III 期試驗的名稱。我們的目標是到 2023 年第二季度完成總共 256 名患者的註冊，指日可待。這是一項預防研究，它告訴您很多關於在癌症治療期間預防腹瀉影響的重要性。 CTD 並不是我們都可能因輕微流感或不良膳食而不可避免地經歷的輕度失控。這是一種可以讓患者住院並導致器官停止運轉的腹瀉。 - 甚至導致一些參加過靶向抗癌劑製造商臨床試驗的患者死亡。對於新的靶向療法，長期使用的癌症療法，無論是在轉移性癌症還是在治愈性癌症的情況下，都需要數月或數年的治療。腹瀉的發生率有時高達 100% 以預測 CTD 的潛在市場機會，因為 crofelemer 將是第一個被批准用於該適應症的藥物，我們正在尋找一個類似的市場，化療引起的噁心和嘔吐，CINV ，它經常被提及，根據 Allied Market Research 發布的一份報告，預計今年全球市場將接近 30 億美元，而 CINV 藥物通常僅在傳統細胞毒性化療的前 3 至 5 天使用，並且這個市場上有很多通用條目。對於 CTD，癌症治療相關的腹瀉，我們談論的是可以持續數月或數年的慢性腹瀉。我們 III 期試驗的入組標準包括所有實體瘤患者——因此一攬子批准、廣泛批准，包括針對所有實體瘤接受或不接受細胞毒性化療的靶向治療患者的預防標籤是我們的標籤擴展尋找 Mytesi。讓我指出，這項試驗是用 Mytesi 的確切配方進行的，這已經被證明，它顯然有一個完整的符合 GMP 標準的供應鏈，並被批准用於慢性適應症。慢性安全性也已完成。 Mytesi 已經解決了安全製造導致新藥申請失敗的 2 個最常見原因。我們對這個具有（聽不清）強大安全性的項目感到非常興奮，我們希望癌症患者能夠長期耐受 Crofelemer 並從中受益。再次成功完成目標關鍵試驗的註冊，目標是 2023 年第二季度。嗯，我們預計會導致 Mytesi 的補充新藥申請提交，正如我提到的，相同的配方目前批准的 crofelemer。在這一最終臨床和監管步驟的設計和執行過程中，我們非常謹慎地與 FDA 進行了廣泛溝通，以支持將 crofelemer 用於患有腹瀉和/或因處方治療而有腹瀉風險的癌症患者。我現在將討論我們針對 crofelemer 的優先或碗綜合症管道適應症。我是 Napo Therapeutics 的董事會主席，這是我們去年在意大利米蘭成立的公司，我們授予 Crofelemer 在歐洲的獨家許可。具體而言，Napo Fera 最初追求的是一種罕見病商業模式，該模式基於 crofelemer 的孤兒藥指定，用於治療伴有腸衰竭的 SBS 和 CDD，Jaguar 是 Napo Therapeutics 的大股東以及該技術的許可方，因此，它提供捷豹的股權價值以及典型的許可條款。讓我描述一下 SBS（聽不清）綜合症患者的災難性醫療狀況。正常的腸道長度為 20、25 英尺。在 SBS 中，患者可能因先天性原因或因癌症、炎症或事故進行手術而身高不足 5 英尺。正如您可以想像的那樣，內臟非常短，就像（聽不清），進去的東西馬上出來。底線是，SBS 患者沒有足夠的腸道表面積來吸收生命中的營養物質、碳水化合物、蛋白質脂肪、維生素和礦物質。因此，發生的情況是，這些患者通常會接受腸外營養，即每週 7 天、每天長達 20 小時的液體營養素靜脈內餵養。顯然，腸外營養對患者的生活質量有顯著的負面影響，並且存在多重負面健康影響、感染、並發症。它的價格昂貴。每年管理一名患者的費用高達數十萬至數百萬至 100 萬美元，其中不僅包括營養價格，還包括發病率和死亡率極高的無數並發症。第三方預計到 2027 年 SBS 的全球市場將達到 50 億美元。這是一份來自 Vision Research 報告的報告。雖然法國營養被認為是護理標準，但有一種藥物產品已獲准用於 SBS（聽不清）替度魯肽，很難發音替度魯肽，它是一種 GLP-2 類似物。它本質上是一種生長激素，旨在稍微生長表面，腸道的不動產，以便有更多的時間進行吸收。它作為註射劑給藥，估計不到 10% 的 SBS 患者使用它，不被視為標準治療。 GLP-2 類似物有一系列副作用，包括心血管風險、內分泌風險，並且不能長期使用。批准替度魯肽的試驗的主要終點是打印營養所需的時間減少約 20%。我們希望用 Crofelemer 做的主要終點是減少腸外營養的時間，並提供更好的糞便形成和生活質量測量，報銷組織表示這對他們很重要。正如我所提到的，Crofelemer 的 SBS 開發正在通過歐洲的 Napo Therapeutics 進行，該公司擁有 Jaguar 的 Crofelemer 在歐洲市場的獨家許可。 Jaguar 是許可人，Napa Therapeutics 是被許可人。這是一個經典的許可協議，包括預付款里程碑和版稅。我們將這家新公司設在歐洲，因為歐盟和歐洲的主要國家，英國（不是歐盟），由於對患者的影響，有針對 SBS 等未滿足醫療需求的孤兒適應症的早期准入計劃。這種類型的早期患者訪問計劃目前在美國不存在。因此，憑藉已發布的概念驗證數據，歐洲特定主要市場的患者可以通過這些早期訪問計劃獲得產品，同時仍在進行全面的批准試驗。早期訪問計劃可以產生收入，對於參與的患者來說，產品是可以報銷的。我們已經批准了一項研究者發起的 CDD 貓科動物 4 SBS 試驗後證明。第三方研究者的目標是在下個月的 2022 年 12 月下個月的世界胃腸病學大會上介紹這項試驗。這是在迪拜舉行的全球地理標誌會議。預計在整個 2023 年，研究人員發起的其他請求和試驗以及臨床數據將來自我們一直保持聯繫的主要意見領袖。正如我提到的，根據特定歐盟國家的指南，此類數據的發布可以支持患者在 2023 年內早期使用 Crofelma 治療 SBS 或 CDD 並伴有腸衰竭。——正如 Jaguar 和 Napo Therapeutics 上個月高興地宣布的那樣歐洲藥品管理局，相當於美國的FDA，歐洲的EMA。 crofelemer 被授予孤兒藥稱號，用於治療微絨毛包涵體病 MVID。這是一種罕見的先天性疾病，因此它是 CDD 的一種形式。而這— 它在歐盟獲得批准。這對 crofelemer 來說是一個非常受歡迎的發展，因為現在它是一種新的分子實體，在不到 1 年的時間內被 EMA 授予孤兒藥資格。 SBS 的孤兒指定於 2021 年 12 月從 EMA 獲得。該分子的監管進展絕對顯著。 Crofelemer 已經在美國獲得了 SBS 的孤兒藥資格。這是一種經典的罕見病，估計全世界約有 40,000 人。同樣，請記住，第三方市場研究表明，罕見疾病的市場機會為 50 億美元，考慮到罕見疾病商業模式的報銷方式，約為 40,000 人。正如我所說，MVID 是 CDD 的一個組成部分，這種情況極為罕見，全世界可能只有幾百名嬰兒。用於 MVID 的 crofelemer 孤兒藥指定申請也已提交給美國 FDA，我們正在等待該指定。 - Napo 療法對 Jaguar 的重要財務重要優勢是 Napo （聽不清）遠遠超過 Jaguar 擁有的多數股權，為 Jaguar 股東和利益相關者提供潛在的股權價值增值，我們認為目前尚未認識到這一點。 Jaguar 還獲得了 Napofhera 生成的任何臨床數據的價值，並且 Napothera 獲得了利用的價值和能力，例如 CTD，Jaguar 正在為其在歐洲的許可區域開發的癌症 III 期數據。因此，Crofelemer 針對這 3 個核心適應症 CTD、SBS 和 CDD 的並行互補和地理集中的開發工作正在與兩個專門的重點和非常有經驗和才華橫溢的團隊在大洋兩岸的相關追求中同步和協作。因此，回顧一下，在大約 6 到 9 個月內，我們預計將完成我們癌症治療相關腹瀉的 III 期試驗的註冊，稱為 ON TARGET 試驗，並發布概念驗證數據以支持潛在的早期訪問計劃2023 年中期在歐洲參與 SBS 和/或 CDD，這可能會帶來可觀的收入，而 Crofelemer 繼續在歐洲進行全面批准的過程，預計近期將發生 2 件變革性事件，支持價值認可，可能將舉措從管道機會轉變為最終有形收入，Crofelemer 手頭有更多有形收入 2022 年人類方面的另一個重要里程碑，我們在今年第三季度完成的是提交研究性新藥申請與 FDA 合作，我們的 NP300 候選藥物可緩解腹瀉症狀（聽不清）。我們很高興在 9 月份聽到 FDA 的消息，他們完成了對我們的 IND 的審查，並得出結論認為 Jaguar 可以繼續其擬議的藥物 I 期臨床試驗。我們感謝國家過敏和傳染病研究所為支持 NP300 臨床前項目提供的部分資金支持。在第一階段試驗完成後，我們準備啟動下一階段的臨床開發計劃（聽不清）——當 Jaguar 擁有必要的資源和帶寬來啟動這些額外的試驗時。我們打算根據 FDA 的經濟激勵計劃尋求熱帶病優先審查憑證，以開髮用於（聽不清）適應症的 NP300。優先審核憑證可以轉讓。在其他公司過去的交易中，其售價從 6700 萬美元到 3.5 億美元不等，一旦 NP300 獲得批准用於與顏色相關的腹瀉適應症並獲得優先審查憑證，便可立即獲得潛在的投資回報。現在，如果我們轉向業務的動物健康方面，這是我們業務中相對較小的方面，但非常重要且有意義。 Crofelemer 也是 Canalevia CA1 的活性成分，這是我們針對化療引起的狗腹瀉的產品，其商業發布活動已經啟動並持續到 2022 年。整個癌症情況確實與人類情況非常相似。與人類一樣，據估計，近 40% 的狗會因腹瀉而停止其疾病緩解化療或轉向亞治療劑量，這意味著這些狗因腹瀉而無法完成治療劑量的化療。狗的舒適度是狗主人在決定是否飼養狗時最重要的考慮因素之一，即使不是最重要的考慮因素。 ——通過癌症治療。可以想像，當狗失去控制時，您無法與狗和整個家庭交談。狗市場有幾個非常重要的因素。據報導，狗的癌症發病率是我們在人類身上看到的癌症發病率的 5 倍。大流行後，美國的狗總數約為 1.08 億美元，即 1.08 億美元。不幸的是，令人心碎的是，大約 50% 的 10 歲以上的狗將在某個時候被診斷出患有癌症。因此，除了這個非常重要的有條件批准的 CID 化療引起的犬腹瀉適應症之外。 Crofelemer 有望在 2023 年第一季度獲得有條件批准，用於治療犬類運動性腹瀉。Jaguar 還自豪地說，我們於今年 5 月在美國啟動了有史以來第一個犬類癌症登記。在紐約的一次活動中，我們無法相信註冊在美國不存在。該項目的首字母縮寫名為 Jaguar Health take charge initiative。建立負責人的目標是評估狗癌症的患病率和胰島素發病率，最重要的是，在這對家庭來說通常是非常孤立和悲慘的事件中，如何讓狗和整個家庭的情況保持舒適，並幫助創造一個支持和教育社區以及來自註冊表的信息。 take charge 活動由（聽不清）發起，這是 Jaguar 令人驚嘆的公關公司，也是 take charge 的財務共同贊助商之一。當然，（聽不清）努力已經產生了超過 8000 萬次媒體印象，以便未來負責更多。我很高興地報告，就在本月，慶祝營銷和傳播卓越表現的 Marcom Awards 計劃獲得了 2 個白金獎或 1 個金獎，這提高了知名度，從而提高了註冊表的價值，並且我們為那裡的（聽不清）運行能力和努力感到非常自豪。在接下來的 12 個月中，可能會出現許多其他新聞。特別是，在業務發展方面，我們擁有 crofelemer 的所有適應症的全球權利。不過，對於我要關注的內容，除了我們的 GI 努力之外，還有 Jaguar 的心理健康重點發展努力，這被稱為 Entheogen Therapeutics Initiative，ETI。該計劃旨在發現和開發源自迷幻和精神活性植物的突破性新型天然藥物，用於潛在治療和潛在治愈精神疾病。這項工作旨在調動 Jaguar 的一項關鍵資產，即我們在 3 年內生成的包含 2,300 種植物和 3,500 種植物提取物的專有圖書館。今年 6 月，Jaguar 和 Filament Health 找到了一份意向書，以簽訂合作協議，在美國開發針對特定精神活性目標適應症的植物處方藥。 Filament 擁有天然和植物價格產品的實驗室、製造、製造 IP 能力，而 Jaguar 作為一家現在專注於後期臨床開發的公司不再具備這些能力。我們將關於如何在 FDA 植物學指導下進行藥物開發的民族植物學專業知識帶到桌面上，這是我們對 Mytesi 的批准。我們的兩家公司正在尋求與資金充足的實體建立合作夥伴關係，以尋求監管部門的批准，並最終在心理健康領域實現新型藥物處方級植物性標準化候選藥物的商業化。 Jaguar in filament 一起在討論中走得很遠。在接下來的幾個月內，我相信您可以期待看到正式的業務發展合作，其中涉及引入非稀釋性資金，以幫助動員和利用捷豹的植物庫來實現非常重要的初始目標，我們正在考慮多動症和社交焦慮症, 2 個市場因大流行病而擴大，這是可以理解的。我相信您也可以期待看到其他業務發展交易即將到來，因為我們承諾。我們的使命是將 crofelemer 帶給世界各地所有有需要的患者群體。最後，我想讓今天參加的所有人知道，我們將在網絡廣播結束時有一個簡短的問答環節，以解決任何以書面形式提交的問題。可以通過 Jaguar 網站投資者關係部分的 Events and Presentations 頁面上顯示的今天活動的網絡直播鏈接提交問題，Jaguar 網站的 URL 是 jaguar.health。我們現在將繼續討論 2022 年第三季度的主要財務業績。我們的首席財務官卡羅爾。我會把它交給你。

Thank you, Lisa, and thank you all for joining our webcast today. I'll begin my review of our financials for the third quarter of 2022. The prescription product net revenue during the third quarter of 2022 was approximately $3.1 million and $2.9 million in the second quarter of 2022, an increase of about $200,000 or 8.2% quarter-over-quarter and an increase of approximately 412% over prescription product debt revenues in the third quarter of 2021. Mytesi prescription volume increased approximately 3% in the third quarter of 2022 over the third quarter of 2022. Prescription volume differs from invoice sales volume, which reflects, among other factors, varying product buying patterns among specialty pharmacies in the closed network as they manage their inventory levels. For the third quarter of 2022, the loss from operations increased by $400,000 from $9.5 million in the third quarter ended September 30, 2021 to $9.9 million during the same period in 2022. Non-GAAP EBITDA for the third quarter of 2022 and the third quarter of 2021 were a net loss of $8.5 million each, respectively. For third quarter of 2022, -- the net loss attributable to common shareholders increased by approximately $300,000 from $12.2 million in the quarter ended September 30, 2021 to $12.5 million in the same period in 2022. In addition to the loss from operations, interest expense increased by $600,000 from $2.1 million in the quarter ended September 30, 2021, to $2.7 million for the same period in 2022, primarily due to interest from the royalty and note agreements. Another one is the change in fair value of financial instruments and hybrid instruments designated at fair value option or FVO increased by $700,000 from a loss of approximately $600,000 in the 3 months ended September 30, 2021, to a gain of about $200,000 for the same period in 2022, primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO. Other expenses also increased by about $100,000 from $20,000 in this quarter ended September 30, 2021 to approximately $200,000 for the same period in 2022, and that's largely due to foreign currency transactions. That concludes my recap of high-level financials for the third quarter of 2022. I will now hand the discussion over to Ian Wendt, Jaguar's Chief Commercial Officer.

謝謝 Lisa，也感謝大家今天參加我們的網絡廣播。我將開始審查我們 2022 年第三季度的財務狀況。2022 年第三季度的處方產品淨收入約為 310 萬美元，2022 年第二季度為 290 萬美元，增加了約 200,000 美元或季度增長 8.2% - 2021 年第三季度與處方產品債務收入相比增長約 412%。Mytesi 處方量在 2022 年第三季度比 2022 年第三季度增長約 3%。處方量與發票銷量不同，除其他因素外，這反映了封閉網絡中專業藥店在管理庫存水平時的不同產品購買模式。 2022 年第三季度，運營虧損從截至 2021 年 9 月 30 日的第三季度的 950 萬美元增加 400,000 美元至 2022 年同期的 990 萬美元。2022 年第三季度和第三季度的非美國通用會計準則 EBITDA 2021 年分別淨虧損 850 萬美元。 2022 年第三季度，歸屬於普通股股東的淨虧損從截至 2021 年 9 月 30 日的季度的 1220 萬美元增加了約 300,000 美元至 2022 年同期的 1250 萬美元。除了運營虧損外，利息支出從截至 2021 年 9 月 30 日的季度的 210 萬美元增加 600,000 美元至 2022 年同期的 270 萬美元，這主要是由於特許權使用費和票據協議產生的利息。另一個是指定為公允價值期權或 FVO 的金融工具和混合工具的公允價值變動增加了 700,000 美元，從截至 2021 年 9 月 30 日的 3 個月的損失約 600,000 美元增加到同期的收益約 200,000 美元2022 年，主要是由於在 FVO 指定的負債分類認股權證和應付票據的公允價值調整。其他費用也增加了約 100,000 美元，從截至 2021 年 9 月 30 日的本季度的 20,000 美元增加到 2022 年同期的約 200,000 美元，這主要是由於外匯交易。我對 2022 年第三季度高級財務狀況的回顧到此結束。我現在將討論交給捷豹首席商務官 Ian Wendt。

Thank you, Carol, and good morning to all. As Carol stated, my test total prescription volume, a metric we believe to be the best indicator of patient demand increased approximately 3% in the third quarter of 2022 over the second quarter of 2022. As previously announced, the transition we completed throughout the end of 2021 and into the beginning of 2022 to a limited distribution network of specialty pharmacies resulted in a meaningful reduction in Mytesi distribution costs as well as a higher average net price. I'm very pleased to report that we significantly outperformed the industry gross to net average in the third quarter of 2022 as we did in the previous -- in the 3 previous quarters as well for sales of our human prescription products. This improvement in our gross to net was largely a result of the efficiencies realized by the transition to a closed network of specialty pharmacies. This transition assists in the preparation of the company's U.S. commercial distribution network for potential future indication expansion of Crofelemer to other populations of patients with complex medical needs, such as CTD, inflammatory bowel disease, SBS and CDD. As Lisa mentioned, Q3 2022 is the fifth consecutive quarter of growth in Mytesi net revenue, which we're also very pleased about. I'm also pleased to report that our innovative recently launched programs that further support patients connecting to care and medication access services are continuing as planned. The first program is our telehealth initiative, which went live in May. This enables patients seeking help with their HIV-related diarrhea to be linked immediately to a provider for assistance with their medical needs. This new capability prevents patients from having to wait until their next scheduled doctor visit to get help with what is a really urgent problem. Our second recently launched program delivers digital Mytesi and disease state education directly into a provider's EHR, that's the electronic health record system. -- so that the provider can learn about Mytesi at the moment they are seeing their HIV patients. This technology allows us to intelligently deliver ads to a provider based on the profile of the patients they are seeing in their exam role. This is strictly a one-way communication. We do not receive any protected health information. Turning to the Animal Health side of our business. Canalevia CA1, our FDA conditionally approved drug for the treatment of chemotherapy-induced diarrhea, or CID and dogs became commercially available to veterinarians across the United States at the end of April 2022, as Lisa mentioned. Since that time, we have succeeded in pushing Canalevia CA1 into broad distribution with the leading veterinary distribution centers. Approximately 40% of the 280 veterinary specialty clinics in the U.S. have already ordered at least 1 bottle of Canalevia C1 -- this is a great indicator that veterinarians are seeing the clinical benefits of our product among their patients. Commercial launch activities for the drug remain underway and reception of Canalevia C-1 among general practice vets and veterinary oncologists continues to be extremely positive. For example, under our Jaguar Animal Health trade name for the veterinary market, we sponsored the October 26, 2022 episode of DBM360 live. This is a web-based magazine-style talk show veterinary professionals hosted by veterinarian, Dr. Adam Prissman, which drives awareness of (inaudible) C1 and encourages veterinary clinics to contribute Canine cancer records to Jaguar's -- take Charge Canine Cancer Registry initiative. -- veterinary oncologists, Dr. Sue Ettinger, who is also known as Dr. Sue Cancer vet appeared on the DBM360 live episode to discuss (inaudible). She was joined on the show by one of our canine patients, a Labrador mix undergoing chemotherapy for sarcoma and the dog's owner, who discussed his pets experience with (inaudible). Additionally, Jaguar Animal Health launched an on-demand webinar for veterinarians on October 27, 2022, titled chemotherapy-induced diarrhea in dogs effectively treating this therapy limiting side effect. U.S. veterinarians who participate in the webinar, which is hosted by veterinary oncologists, Dr. Craig Clifford, are eligible to receive 1 hour of American Association of Vectinary State Boards (inaudible), which stands for registry of approved continuing education. This gives them an improved continuing education credit. This effort represents another way that we are actively engaging with providers one-on-one. And I'm excited to report that attendance for the live for the webcast, both the 2022 record for clinicians (inaudible) who hosted DC training. -- the continuing education provider that hosted the event. We had well over 500 participants and there were a lot of excellent questions, all of which shows a great level of interest among veterinarians about managing and treating chemotherapy-induced diarrhea in dogs. As Lisa mentioned, we expect Canalevia C1 could additionally receive FDA conditional approval under the name candy in the treatment of exercise-induced diarrhea or EID and dogs in the first quarter of 2023. That concludes my comments. Thank you all for your time today, and I'll pass the conversation back to Lisa...

謝謝卡羅爾，大家早上好。正如卡羅爾所說，我的測試總處方量是我們認為是患者需求的最佳指標，在 2022 年第三季度比 2022 年第二季度增加了約 3%。正如之前宣布的那樣，我們在整個年底完成了過渡2021 年到 2022 年初，有限的專業藥店分銷網絡導致 Mytesi 分銷成本顯著降低，平均淨價更高。我很高興地報告，我們在 2022 年第三季度的表現大大優於行業平均水平，就像我們在前三個季度所做的那樣——在前三個季度以及我們人類處方產品的銷售。我們毛淨值的這種改善主要是由於向封閉的專業藥房網絡過渡所實現的效率提高。這一轉變有助於準備公司的美國商業分銷網絡，以便未來將 Crofelemer 的適應症擴展到其他有復雜醫療需求的患者群體，如 CTD、炎症性腸病、SBS 和 CDD。正如 Lisa 提到的，2022 年第三季度是 Mytesi 淨收入連續第五個季度增長，我們也對此感到非常高興。我也很高興地報告，我們最近啟動的創新計劃正在按計劃繼續進行，這些計劃進一步支持連接到護理和藥物獲取服務的患者。第一個項目是我們的遠程醫療計劃，該計劃於 5 月上線。這使得尋求 HIV 相關腹瀉幫助的患者能夠立即與提供者聯繫，以幫助滿足他們的醫療需求。這種新功能使患者不必等到下一次預定的醫生就診時才能獲得真正緊急問題的幫助。我們最近啟動的第二個項目將數字 Mytesi 和疾病狀態教育直接提供給提供者的 EHR，即電子健康記錄系統。 ——這樣提供者就可以在他們看到 HIV 患者時了解 Mytesi。這項技術使我們能夠根據他們在檢查角色中看到的患者的概況，智能地向供應商投放廣告。這嚴格來說是一種單向通信。我們不會收到任何受保護的健康信息。轉向我們業務的動物健康方面。 Canalevia CA1 是我們的 FDA 有條件批准的用於治療化療引起的腹瀉或 CID 和狗的藥物，於 2022 年 4 月底在美國各地的獸醫中上市銷售，正如 Lisa 提到的那樣。從那時起，我們就成功地將 Canalevia CA1 推向了領先的獸醫配送中心的廣泛分銷。美國 280 家獸醫專科診所中約有 40% 已經訂購了至少 1 瓶 Canalevia C1——這是一個很好的指標，表明獸醫正在他們的患者中看到我們產品的臨床益處。該藥物的商業上市活動仍在進行中，全科獸醫和獸醫腫瘤學家對 Canalevia C-1 的接受度仍然非常高。例如，在獸醫市場的 Jaguar Animal Health 商品名下，我們贊助了 2022 年 10 月 26 日播出的 DBM360 直播。這是一個由獸醫 Adam Prissman 博士主持的基於網絡的雜誌式脫口秀，旨在提高人們對（聽不清）C1 的認識，並鼓勵獸醫診所向 Jaguar 提供犬類癌症記錄——負責犬類癌症登記計劃。 -- 獸醫腫瘤學家 Sue Ettinger 博士，也被稱為 Sue Cancer 獸醫博士，出現在 DBM360 直播節目中討論（聽不清）。她和我們的一位犬類患者一起參加了節目，這是一隻正在接受肉瘤化療的拉布拉多混合犬和狗的主人，他與（聽不清）討論了他的寵物經歷。此外，Jaguar Animal Health 於 2022 年 10 月 27 日為獸醫推出了一個點播網絡研討會，標題為有效治療這種療法限制副作用的狗化療引起的腹瀉。參加由獸醫腫瘤學家 Craig Clifford 博士主持的網絡研討會的美國獸醫有資格獲得 1 小時的美國獸醫國家委員會協會（聽不清），這代表經批准的繼續教育登記。這使他們獲得了更好的繼續教育學分。這項工作代表了我們與供應商一對一積極接觸的另一種方式。我很高興地報告網絡直播的現場出席情況，這是 2022 年主持 DC 培訓的臨床醫生（聽不清）的記錄。 -- 主辦該活動的繼續教育提供者。我們有超過 500 名參與者，並且有很多很好的問題，所有這些都表明獸醫對管理和治療化療引起的狗腹瀉有很大的興趣。正如 Lisa 提到的，我們預計 Canalevia C1 可能會在 2023 年第一季度以糖果的名義獲得 FDA 有條件的批准，用於治療運動引起的腹瀉或 EID 和狗。我的評論到此結束。謝謝大家今天抽出時間，我會把談話轉回給麗莎……

Great Apologies, okay. Hopefully, I did go off news here. And thank you, Ian and Carol. And we are all energized about all these important initiatives underway, proud of what we achieved in 2022, very excited about what's coming up and really just around the quarter in pharmaceutical industry terms, 6 to 9 months in 2023.

非常抱歉，好吧。希望我確實在這里關閉了新聞。謝謝你們，伊恩和卡羅爾。我們都對正在進行的所有這些重要舉措充滿活力，為我們在 2022 年取得的成就感到自豪，對即將發生的事情感到非常興奮，實際上就在製藥行業的這個季度左右，即 2023 年的 6 到 9 個月。

So a few questions have come in, and I will take a look at those. Okay.

所以有幾個問題進來了，我會看看這些。好的。

One question is the current ATM at the market that is in use. How much is left to sell?

一個問題是目前市場上正在使用的 ATM。還剩多少可以賣？

So let me tell you something about a company like us having the gift of qualifying and having an ATM in place. We have about $10.7 million -- approximately $11 million in cash reported at the end of the Q. And to be sure that we have sufficient funds to get to the end of, for example, our cancer trial, there may be a need to bring in more funds. And right now, if you look at the financing for companies that are in our range and our market cap, they're terrible. They're structured, their warrants. They really are highly toxic to current investors. And so with the ATM gives us the opportunity to do is bring in cash at the market, no warrants, no bells or whistles down the wheel world when necessary. So we're pleased that we qualify for one, and we do have about $50 million capacity on the ATM. That doesn't mean we're using $50 million of the ATM, but we do have capacity for $50 million on our ATM.

因此，讓我告訴您一些關於像我們這樣的公司具有資格和擁有 ATM 的天賦。我們有大約 1070 萬美元——在 Q 結束時報告了大約 1100 萬美元的現金。為了確保我們有足夠的資金來結束，例如，我們的癌症試驗，可能需要帶來在更多的資金。而現在，如果你看看我們範圍內和市值範圍內的公司的融資情況，就會發現它們很糟糕。他們是結構化的，他們的認股權證。它們對當前的投資者來說確實是劇毒的。因此，有了 ATM，我們就有機會在市場上取現，無需認股權證，必要時也無需花錢或口哨。所以我們很高興我們有資格獲得一個，而且我們的 ATM 機上確實有大約 5000 萬美元的容量。這並不意味著我們正在使用 5000 萬美元的 ATM，但我們的 ATM 確實有 5000 萬美元的容量。

What are the key catalysts you were focused on in the upcoming year? Which of these catalysts do you think are most underappreciated by -- the Street? How do you think the macro environment may affect your business?

您在來年關注的主要催化劑是什麼？您認為這些催化劑中的哪些最被華爾街低估了？您認為宏觀環境會對您的業務產生怎樣的影響？

Okay. I think so much is underappreciated by -- the Street. I think just about everything is underappreciated by -- the Street when we have a market cap that is hovering around $20 million or so, right? This is a company that just reported the fifth straight growth in net revenue for and is in late-stage clinical development for this very same product, this very same formulation that's already approved and on the market for a blockbuster opportunity in terms of unmet medical need for the patients, the impact to move from simply supportive care, which is very important, the comfort of the patient but to also potentially have an impact on cost of treatment and outcome of the cancer patient. When we move to Napo (inaudible), I think that is way under recognized and valued, not only is it an opportunity for meaningful revenue generation in 2023 from meaningful patient impact with short (inaudible) syndrome, but there's also the equity piece of that. We own well over the majority of Napo Therapeutics, which has its own valuation, which can be recognized at the end of the year from the Italian filings. We have another product approval coming up, Canalevia CA-2 for exercise-induced diarrhea that would be our third prescription product approved. We have business development deals that could pop at any time. We did the Mid-East license in February of 2022. We obviously have the license in crofelemer in Europe, but we have other Asian countries available of the rest of world territories and a commitment to bring this product to all these different patient populations. So I'm not sure which one is under -- I'm not sure which one is valued. There seems to be nothing valued. So I think we're all underappreciated by -- the Street. And I think part of it is the macro environment and in particular, the macro environment for biotech and health care. So looking forward to events in all companies in our space to help bring greater recognition to this important industry.

好的。我認為很多事情都被華爾街低估了。當我們的市值徘徊在 2000 萬美元左右時，我認為幾乎所有事情都被華爾街低估了，對吧？這是一家剛剛報告其淨收入連續第五年增長的公司，並且正處於同一產品的後期臨床開發階段，這種相同的配方已經獲得批准並在市場上為未滿足的醫療需求提供重磅炸彈機會對於患者來說，從非常重要的簡單支持性護理轉變為患者的舒適度的影響，但也可能對癌症患者的治療成本和結果產生影響。當我們搬到 Napo（聽不清）時，我認為這是被低估和重視的方式，它不僅是 2023 年從對患有短（聽不清）綜合症的有意義的患者影響中產生有意義的收入的機會，而且還有股權部分.我們擁有 Napo Therapeutics 的大部分股份，它有自己的估值，可以在年底從意大利的文件中確認。我們即將獲得另一個產品批准，Canalevia CA-2 用於治療運動性腹瀉，這將是我們批准的第三個處方產品。我們有隨時可能出現的業務發展交易。我們在 2022 年 2 月獲得了中東許可證。我們顯然在歐洲擁有 crofelemer 的許可證，但我們在世界其他地區也有其他亞洲國家可用，並承諾將該產品帶給所有這些不同的患者群體。所以我不確定哪一個在 - 我不確定哪個是有價值的。似乎沒有什麼值得重視的。所以我認為我們都被華爾街低估了。我認為其中一部分是宏觀環境，特別是生物技術和醫療保健的宏觀環境。因此，期待我們所在領域的所有公司舉辦的活動，以幫助為這個重要行業帶來更大的認可。

Okay. When do you expect the trial to be completed, so you can pursue the vouchers. This is for Calera.

好的。您預計試驗什麼時候完成，以便您可以追索優惠券。這是給卡萊拉的。

So calera is we have, as I've mentioned, the next clinical trials in that -- for that indication are going to be timed for when we have resources to do so without unnecessary or very expensive dilution to our shareholders. So as we get some more events under our belt that are recognized by our shareholders, I think that would be the time to put some resources to the Calera program because it will be a couple of years before the completion and approval of that program, which is then what allows you to have the voucher. So we are very focused on near-term momentum drivers near term, 6 to 9 months or less to really bring value recognition to the undervalued situation at Jaguar now.

因此，正如我已經提到的，calera 是我們的下一個臨床試驗——因為該指示將在我們有資源這樣做的時候進行，而不會對我們的股東造成不必要或非常昂貴的稀釋。因此，隨著我們舉辦更多得到股東認可的活動，我認為現在是時候為 Calera 計劃投入一些資源了，因為該計劃的完成和批准還需要幾年的時間，這那麼是什麼讓你有優惠券。因此，我們非常關注近期的動能驅動因素，即 6 至 9 個月或更短的時間，以真正為 Jaguar 現在被低估的情況帶來價值認可。

Are there plans for mergers and acquisitions in the not-too-distant future?

近期是否有併購計劃？

There are no specific plans for mergers or acquisitions. However, there are no terms in any deals that we have cut or anticipate to be cut that would prevent and merger or acquisition. And certainly, we wouldn't want that to occur at this horrendous valuation at the moment -- thank you. A nice compliment. Thank you for the compliment.

沒有具體的併購計劃。但是，我們已經削減或預計將削減的任何交易中都沒有任何條款會阻止合併或收購。當然，我們不希望這種情況在目前這個可怕的估值下發生——謝謝。一個很好的讚美。謝謝你的誇獎。

What was the third quarter revenue in dog-related therapy and project the third quarter revenues, specifically for the dog-related therapy?

狗相關治療的第三季度收入是多少？預計第三季度的收入，特別是狗相關治療？

Carol, I don't think we broke that out. Did we break that out in the Q?

卡羅爾，我不認為我們打破了它。我們是否在 Q 中打破了這一點？

Yes, it's on the 10-Q, yes, the Canalevia because we have human health and animal health. And do you know what that number revenue beyond looking at the moment.

是的，它在 10-Q 上，是的，Canalevia，因為我們有人類健康和動物健康。你知道現在的收入是多少嗎？

And remember, this product was launched in the end of the second quarter, and that's when the loading occurs to the distributors...

請記住，該產品是在第二季度末推出的，那是經銷商加載的時候......

About $150,000 for Canalevia. Right thank you

Canalevia 的售價約為 150,000 美元。對的 謝謝

And that is all the questions. So thank you all very much for listening. We look forward to 2023, and we will look forward to speaking to you again when RK results come out, and that will be in 2023 as well. Bye-bye. Happy next year.

這就是所有的問題。非常感謝大家的聆聽。我們期待 2023 年，我們也期待在 RK 結果出來時再次與您交談，那也將是在 2023 年。再見。明年快樂。

Thank you. That will conclude today's conference call. Thank you for your participation. Ladies and gentlemen, you may now...

謝謝你。今天的電話會議到此結束。感謝您的參與。女士們，先生們，你們現在可以...