|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VolitionRx 收益報告的主要要點(2024 年3 月)營收成長:第四季營收:24.4 萬美元,年成長104% 全年營收:77.5 萬美元,年成長153% 預計2024 年將出現強勁成長軌跡,尤其是Nu 。Q Vet 癌症測試擴展Nu.Q Vet 癌症測試:與Fujifilm Vet Systems、Heska 和Antech 建立新的分銷合作夥伴關係預計將帶來現金收益,並可透過Heska 和Antech 作為內部診斷癌症檢測開發:用於膿毒症診斷的Nu.Q NET有前景的臨床相關性Capture-PCR是一種突破性的液體活檢方法,可從血液中分離出腫瘤來源的DNA公司展望:透過產品收入、里程碑付款、向外許可和非稀釋性融資實現正收入的目標Nu.Q Discover預計將增長一倍以上2024 年收入重點透過非稀釋來源和許可機會為Nu.Q NET 提供資金看漲亮點:對Capture-PCR 許可的濃厚興趣Heska 許可協議的遞延收入預計將於今年開始盈利獸醫和Nu.Q Discover 收入流的毛利率強勁看跌亮點:Nu.Q Discover 項目的收入由於項目性質和時間安排而難以預測獸醫收入的增長取決於新經銷商的推出
VolitionRx Limited (NYSE: VNRX) reported significant revenue growth in its fourth quarter and full year 2023 earnings call on March 26, 2024. The company's revenue for the quarter was $244,000, marking a 104% increase from the previous year's quarter. The full-year revenue reached $775,000, a 153% increase compared to the prior year.
VolitionRx Limited(NYSE:VNRX)於2024年3月26日召開的財報電話會議上報告稱,其第四季度和2023年全年營收顯著增長。該公司本季營收為244,000美元,較上年同期成長104%。全年營收達77.5萬美元,比上年成長153%。
VolitionRx is optimistic about its revenue growth trajectory, particularly with the anticipated acceleration in 2024 due to the expansion of its distribution network for the Nu.Q Vet cancer test. The company also highlighted its progress in the development of cancer detection methods, including Nu.Q NET for sepsis diagnosis and Capture-PCR for isolating tumor-derived DNA from blood.
VolitionRx 對其收入成長軌跡持樂觀態度,特別是由於 Nu.Q Vet 癌症測試分銷網絡的擴展,預計 2024 年收入將加速成長。該公司還強調了其在癌症檢測方法開發方面的進展,包括用於膿毒症診斷的 Nu.Q NET 和用於從血液中分離腫瘤衍生 DNA 的 Capture-PCR。
Key Takeaways
- Q4 revenue increased by 104% year-over-year to $244,000; full-year revenue up by 153% to $775,000.
- Nu.Q Vet cancer test to be rolled out countrywide through Fujifilm Vet Systems and available through Heska (NASDAQ:HSKA) and Antech.
- Nu.Q NET method for sepsis diagnosis showing promising clinical correlations; more data expected by year-end.
- Capture-PCR cancer detection method development progressing, with commercial discussions underway.
- Company targeting breakeven through product revenues, milestone payments, out-licensing, and non-dilutive funding.
- Veterinary sector revenue grew by 194% to $475,000; Nu.Q Discover generated $300,000 in revenue with over $1 million in pipeline projects.
Company Outlook
- Expectation of strong revenue growth from Nu.Q vet cancer test in 2024 and beyond.
- Nu.Q Discover revenue expected to double in 2024 with a project pipeline valued at over $1 million.
- Plans to achieve breakeven through a combination of revenue streams, including milestone payments and out-licensing.
- Nu.Q vet aimed to be cash positive; Nu.Q Discover projected to be profitable in 2025.
- Seeking $25 million in project funding for Nu.Q NET and exploring licensing opportunities for CTCF and Nu.Q cancer technologies.
Bearish Highlights
- Revenue from Nu.Q Discover projects difficult to forecast due to project nature and timing.
- Veterinary revenue ramp-up dependent on the launch of new distributors.
Bullish Highlights
- Significant interest in licensing the Capture-PCR technology.
- $23 million in deferred income from Heska license agreement expected to start earning out this year.
- Both veterinary and Nu.Q Discover revenue streams have good gross margins, with higher profitability expected at scale.
Misses
- No specific misses were discussed in the provided summary.
Q&A Highlights
- Company working with governmental agencies to secure funding for bedside cancer detection test.
- Open to divesting or spinning off veterinary side to fund human sepsis trials.
- Company focusing on larger, more prevalent cancers for detection technology.
- Optimizing solid tumor detection test for potential licensing deals.
VolitionRx emphasized its commitment to generating revenue through licensing and upfront milestone payments and expressed confidence in the potential of its technology to detect various types of cancer. The company also revealed cost-cutting measures totaling $2 million and expressed gratitude for positive feedback on its webinars. Plans to update investors in the coming months were mentioned, with a first-quarter earnings call scheduled for mid-May.
主要要點第四季營收年增 104% 至 244,000 美元;全年營收成長153%,達到775,000 美元。Nu.Q Vet 癌症測試將透過Fujifilm Vet Systems 在全國推廣,並可透過Heska(NASDAQ:HSKA)和Antech.Nu.Q NET 膿毒症診斷方法提供,顯示出有希望的臨床相關性;預計到年底會有更多數據。Capture-PCR 癌症檢測方法開發正在進行,商業討論正在進行中。公司的目標是透過產品收入、里程碑付款、向外許可和非稀釋資金實現盈虧平衡。獸醫部門收入成長194%,達到475,000 美元; Nu.Q Discover 創造了30 萬美元的收入,有超過100 萬美元的管道項目。公司展望預計2024 年及以後Nu.Q 獸醫癌症測試收入將強勁增長。Nu.Q Discover 的收入預計將在2024 年翻一番,管道項目價值為超過 100 萬美元。計劃透過收入流組合實現收支平衡,包括里程碑付款和向外許可。Nu.Q vet 的目標是現金積極; Nu.Q Discover 預計將於2025 年實現盈利。為Nu.Q NET 尋求2500 萬美元的項目資金,並探索CTCF 和Nu.Q 癌症技術的許可機會。看跌亮點Nu.Q Discover 項目的收入由於項目性質而難以預測獸醫收入的成長取決於新經銷商的推出。看漲亮點對 Capture-PCR 技術許可的濃厚興趣。Heska 授權協議的 2,300 萬美元遞延收入預計今年開始盈利。獸醫和 Nu.Q 都發現收入流具有良好的毛利率,預計規模化盈利能力會更高。失誤提供的摘要中沒有討論具體的失誤。問答亮點公司與政府機構合作,確保床邊癌症檢測測試的資金。願意剝離或分拆獸醫方面以提供資金人類膿毒症試驗。公司專注於更大、更普遍的癌症檢測技術。優化實體瘤檢測測試以獲得潛在的許可交易。VolitionRx 強調其通過許可和預付款里程碑付款來創造收入的承諾,並對其檢測技術的潛力表示信心各種類型的癌症。該公司還透露了總計 200 萬美元的成本削減措施,並對網路研討會的正面回饋表示感謝。他們提到了未來幾個月向投資者通報最新情況的計劃,第一季財報電話會議定於五月中旬舉行。
InvestingPro Insights
VolitionRx Limited's recent earnings report showcased impressive revenue growth, but a closer look at the company's financial health through InvestingPro data and insights reveals a more nuanced picture. Here's what potential investors should consider:
InvestingPro InsightsVolitionRx Limited 最近的收益報告顯示了令人印象深刻的收入成長,但透過 InvestingPro 數據和見解仔細觀察該公司的財務狀況會發現更微妙的情況。潛在投資者應考慮以下事項:
InvestingPro Data:
投資專業數據:
- Revenue for the last twelve months as of Q4 2023: $0.78M USD
- Revenue growth for the last twelve months as of Q4 2023: 153.04%
- Gross Profit Margin for the last twelve months as of Q4 2023: 100%
InvestingPro Tips:
截至2023 年第四季的過去十二個月的營收:78 萬美元截至2023 年第四季的過去十二個月的營收成長:153.04% 截至2023 年第四季的過去十二個月的毛利率:100%InvestingPro 提示:
- Analysts forecast continued sales growth for VolitionRx in the current year, aligning with the company's positive outlook for its Nu.Q Vet cancer test and other diagnostic solutions.
- However, VolitionRx is quickly depleting its cash reserves, and its short-term obligations currently outweigh its liquid assets, which could pose financial risks if not managed properly.
For investors considering VolitionRx, these metrics and insights provide a deeper understanding of the company's performance and potential challenges. It's worth noting that, based on the InvestingPro platform, there are 9 additional InvestingPro Tips available for VolitionRx, which could further inform investment decisions. Users interested in gaining access to these tips and more detailed analytics can take advantage of an exclusive offer by using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
分析師預測VolitionRx 今年的銷售額將持續成長,這與該公司對其Nu.Q Vet 癌症測試和其他診斷解決方案的積極前景一致。然而,VolitionRx 正在迅速耗盡其現金儲備,其短期債務目前超過了其現金儲備流動資產,如果管理不當可能會帶來財務風險。對於考慮 VolitionRx 的投資者來說,這些指標和見解可以讓他們更深入地了解公司的績效和潛在挑戰。值得注意的是,基於 InvestingPro 平台,VolitionRx 還提供了 9 個額外的 InvestingPro Tips,可以進一步為投資決策提供資訊。有興趣了解這些技巧和更詳細分析的用戶可以使用優惠券代碼 PRONEWS24 享受獨家優惠,獲得每年或每兩年一次的 Pro 和 Pro+ 訂閱額外 10% 的折扣。
Full transcript - Volitionrx Ltd (VNRX) Q4 2023:
Operator: Good morning, ladies and gentlemen, and thank you for standing by. Welcome to VolitionRx Limited Fourth Quarter and Full Year 2023 Earnings Conference Call. During today's presentation, all parties will be in a listen-only mode. Following the presentation, the conference call will be open for questions. [Operator Instructions]. This conference call is being recorded today, March 26, 2024. I would now like to turn the conference over to Louise Batchelor, Group Chief Marketing and Communications Officer. Please go ahead.
完整文字記錄 - Volitionrx Ltd (VNRX) 2023 年第 4 季:操作員:早安,女士們、先生們,感謝你們的支持。歡迎參加 VolitionRx Limited 2023 年第四季和全年財報電話會議。在今天的演示過程中,各方都將處於僅聽模式。演講結束後,電話會議將開放供提問。 [操作員說明]。本次電話會議於今天(2024 年 3 月 26 日)進行錄製。我現在將會議交給集團首席行銷與傳播長 Louise Batchelor。請繼續。
Louise Batchelor: Thank you, and welcome, everyone to today's earnings conference call for VolitionRx Limited. Before we begin, I'd like to remind everyone that some of the information discussed on this conference call will include forward-looking statements covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on our beliefs as well as assumptions we have used based upon information currently available to us. Because these statements reflect our current views concerning future events, these statements involve risks, uncertainties and assumptions. Actual future results may vary significantly based on a number of factors that may cause the actual results or events to be materially different from future results, performance or achievements expressed or implied by these statements. We have identified various risk factors associated with our operations in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. We do not undertake an obligation to update any forward-looking statements made during the course of this call. I am joined today by Mr. Cameron Reynolds, President and Group Chief Executive Officer, Mr. Terig Hughes, Group Chief Financial Officer Doctor, Dr. Tom Butera, Chief Executive Officer of our Volition Veterinary Subsidiary and Dr. Andrew Retter, currently Medical Consultant to Volition, which has recently announced due to join Volition n the role of Chief Medical Officer in April 2024. During the call, we will cover Volition's financial and operating results for the fourth quarter and full fiscal year of 2023, along with a discussion of our recent activities and upcoming milestones. Following our prepared remarks, we will open the conference call to a question-and-answer session. I'll now turn the call over to Cameron Reynolds. Cameron?
Louise Batchelor:謝謝並歡迎大家參加今天的 VolitionRx Limited 收益電話會議。在我們開始之前,我想提醒大家,本次電話會議討論的一些資訊將包括 1995 年《私人證券訴訟改革法案》安全港條款所涵蓋的前瞻性陳述。這些陳述基於我們的信念以及我們根據當前可獲得的資訊使用的假設。由於這些陳述反映了我們目前對未來事件的看法,因此這些陳述涉及風險、不確定性和假設。未來的實際結果可能會因多種因素而顯著不同,這些因素可能導致實際結果或事件與這些陳述中明示或暗示的未來結果、績效或成就有重大差異。我們在最近的 10-K 表年度報告、10-Q 表季度報告以及向美國證券交易委員會提交的其他文件中確定了與我們營運相關的各種風險因素。我們不承擔更新本次電話會議期間所做的任何前瞻性陳述的義務。今天與我一起出席的還有總裁兼集團首席執行官 Cameron Reynolds 先生、集團首席財務官 Terig Hughes 先生、醫生、Volition 獸醫子公司首席執行官 Tom Butera 博士以及現任醫療顧問 Andrew Retter 博士Volition 最近宣布將於2024 年4 月加入Volition,擔任首席醫療官。在電話會議中,我們將介紹Volition 的第四季度和2023 年整個財年的財務和營運業績,並討論我們最近的活動和即將到來的里程碑。在我們準備好的發言之後,我們將在電話會議上進行問答環節。我現在將把電話轉給卡梅倫·雷諾茲。卡梅倫?
Cameron Reynolds: Thanks Lou, and thank you, everyone, for joining Volition's fourth quarter and full year 2023 earnings call today. We appreciate your time given the busy annual 10-K filing season. We will commence the call with a financial report from our Group Chief Financial Officer, Terig Hughes, before moving on to a prerecorded update from Dr. Tom Butera, Chief Executive Officer of Volition Vet on the rollout of our Nu.Q vet cancer test. And I'm delighted to welcome Dr. Andy Retter to the call to provide an update on the Nu.Q NET and Capture-PCR. As was announced last week, Andy will be joining Volition as our Chief Medical Officer beginning April 1st. Many of you will have heard from Andy previously, but I'd like to formally share his credentials. Dr. Butera is an intensive care consultant at Guy's and St Thomas' NHS Foundation Trust in London, where he has worked as a consultant since 2014 and leads clinical governance in critical care. He specializes in the management of severe respiratory failure, ECMO and thrombosis. Dr. Butera is the only consultant in the UK to hold dual entry on the specialist register in Intensive Care and Hematology and provides national guidance on the management of complex hematology patients in clinical care. He will continue his clinical and research duties at Guy's and St Thomas' NHS Foundation Trust after joining Volition. Dr. Butera has worked with Volition in an advisory capacity since January of 2022. To help guide the product development and clinical utility of Nu.Q NET's, a CE-Marked routine blood test to detect disease associated with NETosis, such as sepsis. The whole team are absolutely delighted to be welcoming Andy more formally into Volition. As Chief Medical Officer, he will be vital to our success, ensuring the needs of the patient are placed at the heart of our research, development and commercialization activities. It's great to have you on board, Andy. And I must say your enthusiasm for our mission and platform really helps us to fully understand the great importance of the work we do. Following Andy's update, I will wrap up with my thoughts and upcoming milestones and discuss our overall strategy going forward. Without further ado, I'll hand you across to Terry for our financial report. Terry?
Cameron Reynolds:感謝 Lou,也感謝大家今天參加 Volition 的第四季和 2023 年全年財報電話會議。鑑於每年繁忙的 10-K 申請季節,我們感謝您抽出寶貴的時間。我們將首先由集團財務長 Terig Hughes 提交財務報告,然後由 Volition Vet 執行長 Tom Butera 博士預先錄製關於推出 Nu.Q 獸醫癌症測試的最新情況。我很高興歡迎 Andy Retter 博士參加電話會議,提供有關 Nu.Q NET 和 Capture-PCR 的最新資訊。正如上周宣布的那樣,Andy 將從 4 月 1 日開始加入 Volition,擔任我們的首席醫療官。你們中的許多人以前都聽說過安迪,但我想正式分享他的資歷。 Butera 博士是倫敦蓋伊和聖托馬斯 NHS 基金會信託基金的重症監護顧問,自 2014 年以來一直擔任顧問,領導重症監護的臨床治理。他專門從事嚴重呼吸衰竭、ECMO 和血栓形成的治療。 Butera 博士是英國唯一一位在重症監護和血液學專家名冊上持有雙重資格的顧問,並為臨床護理中複雜血液病患者的管理提供國家指導。加入 Volition 後,他將繼續在蓋伊和聖托馬斯 NHS 基金會信託基金擔任臨床和研究職位。 Butera 博士自2022 年1 月以來一直以顧問身份與Volition 合作。幫助指導Nu.Q NET 的產品開發和臨床應用,Nu.Q NET 是一種具有CE 標誌的常規血液檢測,用於檢測與NETosis 相關的疾病,例如敗血症。整個團隊非常高興地歡迎 Andy 更正式地加入 Volition。作為首席醫療官,他對我們的成功至關重要,確保患者的需求成為我們研究、開發和商業化活動的核心。很高興你能加入,安迪。我必須說,你們對我們的使命和平台的熱情確實幫助我們充分理解了我們所做工作的重要性。在安迪更新後,我將總結我的想法和即將到來的里程碑,並討論我們未來的整體策略。言歸正傳,我將把我們的財務報告交給特里。特里?
Terig Hughes: Thanks very much, Cameron, and thank you everyone for joining our earnings call today. I'll now provide a summary of the key financial results for the quarter ended December 31 full year 2023. From a revenue perspective, we recorded revenue of $244,000 for the quarter, a 104% increase over the same period last year. For the full year 2023, we recorded revenue of $775,000 an increase of 153% over the prior year. We believe that these results demonstrate steady progress, but not yet the ramp in revenues that we anticipate. We expect revenues to accelerate in 2024 as several additional distributors come online with our Nu.Q vet cancer test, in particular, Antech and FujiVet who are both about to launch and our Nu.Q discover pipeline continues to grow. 2023 full-year revenue of the Nu.Q Vet cancer test was $475,000 a year-on-year increase of 194%, mainly reflecting sales of reference kits through our agreement with IDEXX. Revenues in Nu.Q discover for 2023 was $300,000, which reflects 107% growth over 2022. Moving on to the balance sheet. We ended the year with cash and cash equivalents of approximately $20.7 million compared with $10.9 million at the end of 2022. Net cash generated from operating activities during the fourth quarter 2023 was approximately $6.4 million and reflected the receipt of $13 million in milestone payments from Heska Corporation in December. For the full year 2023, net cash used in operating activities was $18.1 million, compared to $15.3 million in the prior year. Net loss for fourth quarter 2023 was $8.8 million, compared to $7.3 million for the fourth quarter 2022 and for the full year, $35.7 million, compared to $30.6 million in 2022. This increase was primarily the result of increased Research & Development expenditures mainly reflecting the cost of our U.S. clinical trials which added $3.1 million to the P&L costs in 2023. To date, various European funding bodies and in particular, Belgian agencies have committed to the company over $21 million in non-dilutive funding in various forms, including cash grants and loans on favorable terms. In the fourth quarter, our Walloon institutional fund and regional government bodies of the Walloon region of Belgium committed additional funding to the company aggregating approximately $5.5 million of which approximately one half was in the form of a loan. We would like to publicly thank the various government agencies of Belgium for their continued support. We have also initiated efforts with respect to seeking non-dilutive funding in the U.S. Our aim is to fund some of our major programs through either non-dilutive or project financing, which we anticipate could be substantial over the next two years. As mentioned earlier, at the end of fourth quarter, we received $13 million in milestone payments from Heska Corporation, now an Antech company and part of Mars Petcare, one of the largest pet health companies in the world. And so, to recap, we ended the year with cash and cash equivalents of $20.7 million. With that said, I believe that we are well-placed to execute the plans the team have in place for 2024. And with that, I will pass over to Dr. Tom Butera, CEO of our Volition Veterinary subsidiary. Tom?
特里格·休斯:非常感謝卡梅倫,也感謝大家今天參加我們的財報電話會議。現在,我將提供截至 2023 年 12 月 31 日的季度的主要財務業績摘要。從收入角度來看,我們該季度的收入為 244,000 美元,比去年同期增長 104%。 2023 年全年,我們的收入為 775,000 美元,比前一年增長 153%。我們相信這些結果顯示了穩步進展,但收入尚未達到我們預期的成長。我們預計,隨著更多經銷商上線我們的 Nu.Q 獸醫癌症測試,特別是即將推出的 Antech 和 FujiVet,並且我們的 Nu.Q 發現管道繼續增長,我們預計 2024 年收入將加速增長。 Nu.Q Vet癌症檢測2023年全年收入為475,000美元,年增194%,主要反映透過我們與IDEXX的協議銷售參考試劑盒。 Nu.Q discovery 2023 年的收入為 300,000 美元,比 2022 年增長 107%。轉向資產負債表。截至年底,我們的現金和現金等價物約為2,070 萬美元,而2022 年底為1,090 萬美元。2023 年第四季經營活動產生的現金淨額約為640 萬美元,反映了從Heska 收到的1,300 萬美元的里程碑付款12月成立公司。 2023 年全年,經營活動使用的現金淨額為 1,810 萬美元,而前一年為 1,530 萬美元。 2023 年第四季的淨虧損為880 萬美元,而2022 年第四季為730 萬美元;全年淨虧損為3,570 萬美元,而2022 年為3,060 萬美元。這一增長主要是由於研發支出增加,主要反映了我們的美國臨床試驗成本使2023 年的損益成本增加了310 萬美元。迄今為止,各個歐洲資助機構,特別是比利時機構已承諾以各種形式向該公司提供超過2100 萬美元的非稀釋性資金,包括現金補助以及優惠條件的貸款。第四季度,我們的瓦隆機構基金和比利時瓦隆地區政府機構承諾向該公司提供總計約 550 萬美元的額外資金,其中約一半以貸款形式提供。我們要公開感謝比利時各政府機構的持續支持。我們也開始努力在美國尋求非稀釋性資金。我們的目標是透過非稀釋性融資或專案融資為我們的一些重大專案提供資金,我們預計這在未來兩年內可能會很大。如前所述,第四季末,我們從 Heska Corporation 收到了 1300 萬美元的里程碑付款,Heska Corporation 現在是 Antech 公司,是世界上最大的寵物保健公司之一瑪氏寵物護理公司的一部分。因此,回顧一下,我們年底的現金和現金等價物為 2,070 萬美元。話雖如此,我相信我們有能力執行團隊為 2024 年制定的計劃。接下來,我將把任務交給我們 Volition Veterinary 子公司的執行長 Tom Butera 博士。湯姆?
Tom Butera: Thanks very much, Terig, and good morning everybody. In 2023, we supplied kits and components for over 58,000 tests, 5 times the number in the prior year. This growth demonstrates solid progress to date and we certainly expect more growth to come as additional companies fully launch our product at home in the United States and around the world. By the end of 2023, the Nu.Q Vet cancer test was available in the United States, the United Kingdom, and Ireland, Portugal, Singapore, Taiwan and Italy. 2023 was a breakthrough year for Volition Veterinary gaining such wide distribution and with such respected companies, so kudos to the team and a special thanks to our legal department. We have also learned a great deal, launching and introducing a new product in veterinary medicine, especially early cancer detection in dogs takes a tremendous amount of education to teach veterinarians how to incorporate this early cancer dialogue into their routine wellness visits. Our Nu.Q test also requires an additional cost to the client, which is part of our educational conversation in teaching doctors how to easily make this part of their wellness office visit Additionally, we are always emphasizing the affordable cost of our test and encouraging doctors to keep the test at very reasonable margins. The fact is clearly related to the very large number of dogs that they will be screened for early cancer detection. All-in-all, I believe our Volition team will look back on 2023 as a proud pivotal moment in the burgeoning field of early canine cancer detection, setting the stage to improve and extend the lives of millions of dogs in the months years to come. We have also launched the Nu.Q test with IDEXX, one of the world's leading veterinary diagnostic companies and now Heska, an Antech company and part of Mars Petcare, another leading veterinary company in completing the exciting tech transfer onto the Heska Element I+ in-house diagnostic platform. More recently, as you will have seen in an announcement just last week, we have signed a supply agreement with Fujifilm Vet Systems for our Nu.Q Vet Cancer Test in Japan. Indeed, I have prerecorded my update for today's call as I am currently over in Japan with our colleagues from Fuji and Wow! What an incredible event this last week. We were delighted to be deeply engaged with our Fuji colleagues at their veterinary booth located at the World Veterinary Cancer Congress in Tokyo. This event also provided a significant exposure to numerous veterinary cancer specialists from around the world. We believe that Japan is a considerable market opportunity for Volition as we seek to expand our Nu.Q Vet Cancer Test offering in Asia and Fuji is a great partner with us. Fujifilm Vet Systems as Japan's leading veterinary diagnostic laboratory service with a network of 10 laboratories serving more than 90% of the 12,000 veterinary clinics and hospitals nationwide in Japan. As a reminder, our test is a simple, affordable, easy to use blood-screening test that can be easily integrated into preventive care programs and used alongside other routine blood work during regular wellness visits. We had an incredibly busy time at the Fuji booth and have been excited not only to see the response to the test, but also to hear about the exciting marketing plans Fuji has in place to drive the adoption of Nu.Q. Heather also had the privilege of presenting a poster about the Nu.Q Vet Cancer Test at the Congress. It's been a busy few days and we look forward to working alongside Fujifilm Vet Systems as they roll out our test countrywide across their extensive diagnostic laboratory network. We are also incredibly excited that the Nu.Q Vet cancer test will soon be available as an in-house diagnostic via Heska and Antech company. We understand preorders are currently being processed and the test will be rolled out fully at their upcoming national sales meeting at the end of this month. Soon veterinarians will have accurate in hospital fast test results in under eight minutes, so that they can discuss findings with pet owners and hopefully develop an action plan before the patient even goes home. Antech is initially pricing the test at $35 to the veterinarian and we really believe that the relatively low cost combined with the effectiveness of our test will help drive adoption of the test not only as a screening test, but also in time as an important monitoring tool for disease progression and remission. So, to quote Cameron, very exciting times indeed. That's a quick update for me given our packed agenda today. I will now with absolute great pleasure hand over to our incoming Chief Medical Officer, Dr. Andrew Retter. Andy is a fabulous addition to our leadership team. Andy, over to you for an update on Nu.Q NET.
Tom Butera:非常感謝,Terig,大家早安。 2023 年,我們為超過 58,000 次測試提供了套件和組件,是前一年的 5 倍。這一成長表明迄今為止取得了堅實的進展,隨著更多公司在美國和世界各地全面推出我們的產品,我們當然預計會出現更多成長。到 2023 年底,Nu.Q Vet 癌症檢測已在美國、英國、愛爾蘭、葡萄牙、新加坡、台灣和義大利推出。 2023 年對 Volition Veterinary 來說是突破性的一年,獲得瞭如此廣泛的分銷和如此受人尊敬的公司,因此我們的團隊值得讚揚,並特別感謝我們的法律部門。我們也學到了很多東西,推出和推出獸醫醫學新產品,特別是狗的早期癌症檢測,需要大量的教育來教導獸醫如何將這種早期癌症對話納入他們的日常健康訪問中。我們的 Nu.Q 測試還需要客戶支付額外費用,這是我們教育對話的一部分,教導醫生如何輕鬆地將這一部分納入他們的健康辦公室訪問此外,我們始終強調我們的測試成本可承受,並鼓勵醫生將測試保持在非常合理的範圍內。這一事實顯然與大量狗將接受早期癌症檢測篩檢有關。總而言之,我相信我們的Volition 團隊將回顧2023 年,將其視為犬類早期癌症檢測這一新興領域的一個令人自豪的關鍵時刻,為在未來幾個月改善和延長數百萬隻狗的生命奠定了基礎。我們還與IDEXX(世界領先的獸醫診斷公司之一)以及現在的Heska(Antech 公司和另一家領先的獸醫公司Mars Petcare 的一部分)一起啟動了Nu.Q 測試,完成了令人興奮的技術轉移到Heska Element I+ in-房屋診斷平台。最近,正如您在上週的公告中看到的那樣,我們與 Fujifilm Vet Systems 簽署了一份供應協議,為我們在日本的 Nu.Q Vet 癌症測試提供服務。事實上,我已經預先錄製了今天電話會議的最新情況,因為我目前正在日本與 Fuji 和 Wow! 的同事一起。上週發生了多麼令人難以置信的事件。我們很高興能在東京世界獸醫癌症大會的獸醫展位上與富士同事進行深入交流。這項活動也為來自世界各地的眾多獸醫癌症專家提供了重要的接觸機會。我們相信,日本對 Volition 來說是一個巨大的市場機會,因為我們尋求在亞洲擴展我們的 Nu.Q 獸醫癌症檢測產品,而富士是我們的絕佳合作夥伴。 Fujifilm Vet Systems 是日本領先的獸醫診斷實驗室服務公司,擁有 10 個實驗室網絡,為日本全國 12,000 家獸醫診所和醫院中的 90% 以上提供服務。提醒一下,我們的測試是一種簡單、經濟實惠、易於使用的血液篩檢測試,可以輕鬆整合到預防保健計劃中,並在定期健康就診期間與其他常規血液檢查一起使用。我們在富士展位度過了一段非常忙碌的時光,不僅很高興看到測試的反應,而且還聽到富士為推動 Nu.Q 的採用而製定的令人興奮的營銷計劃。 Heather 也很榮幸在大會上展示了有關 Nu.Q 獸醫癌症測試的海報。這幾天很忙,我們期待與 Fujifilm Vet Systems 合作,透過其廣泛的診斷實驗室網路在全國推出我們的測試。我們也非常興奮的是,Nu.Q Vet 癌症測試很快就會透過 Heska 和 Antech 公司作為內部診斷提供。據我們了解,預訂單目前正在處理中,測試將在本月底即將舉行的全國銷售會議上全面展開。很快,獸醫將在八分鐘內獲得準確的醫院快速測試結果,以便他們可以與寵物主人討論結果,並預計在患者回家之前製定行動計劃。 Antech 最初給獸醫的測試定價為 35 美元,我們堅信相對較低的成本加上我們測試的有效性將有助於推動該測試的採用,不僅作為篩檢測試,而且及時作為重要的監測工具用於疾病進展和緩解。所以,用卡梅倫的話來說,這確實是非常令人興奮的時刻。鑑於我們今天的議程排得滿滿的,這對我來說是一個快速的更新。現在,我非常高興地將工作移交給我們即將上任的首席醫療官安德魯·雷特 (Andrew Retter) 博士。安迪是我們領導團隊的絕佳補充。 Andy,請您了解 Nu.Q NET 的最新情況。
Andrew Retter: Thank you very much for those kind words, Tom, and good morning, everybody. I'd just like to take a moment to start by thanking Cameron, Jake and the Board of Directors for working with me and inviting me to join the Volition team at such an important time. I've really enjoyed working with Volition for the last two years, and I'm really excited about leaning into and contributing to delivery of our mission purpose in the years to come. We really hope to have an impact to improve the lives and quality of lives of millions of people worldwide. I'd like to update you this morning on some of the significant progress we've made with Nu.Q NET and our new breakthrough cancer detection method, which we now call Capture-PCR. So first, starting with NETosis and sepsis. Sepsis, as you've heard me say before, is one of the leading of causes of death worldwide with almost 50 million cases annually and around 11 million deaths. Physicians made significant progress trying to address these issues in 2023, and I'd just like to recap a few highlights. In September, Volition hosted a key opinion leader roundtable event in Athens, Greece. The workshop held over the course of two days focused exclusively on sepsis and the potential role of Nu.Q NET is attended by some of the world's leading experts. Many of the attendees are operating under the umbrella of our Center of Excellence program with Nu.Q NET and have firsthand experience using assay now. The sense from the group was that Nu.Q NET potentially represents one of the biggest breakthroughs in the diagnosis and monitoring of sepsis in the last 30 years. We're moving forward with this group and I'm now working on a review article with the intention to submit it for peer review and publication in a journal towards the end of the year. Continuing in the theme of publication, shortly after our Canadian opinion leader event and subsequent to quarter end in October, the first clinical paper from our clinical excellence group was published. Professor Gila Monterrey's team in Leon published data demonstrating the correlation of the Nu.Q NET level and sepsis. There is a clear mortality signal. What does that mean? The higher patients Nu.Q NET level unfortunately the more likely they are to die. We've also seen in a longitudinal fashion that Nu.Q NET level tracks very well with the severity of the patient's illness. We've been using something called the sepsis score, the sequential organ failure assessment score to calibrate and check Nu.Q NET levels. It's brilliant that we've got the first paper out and I'm really looking forward to publishing and sharing with you more data from our centers of excellence as we go through 2024 and 2025. Over in the U.S., I'm pleased to report that Volition completed the Q sub process with the U.S. Food and Drug Administration. The FDA has confirmed that we can continue to follow a traditional 5, 10-K pathway. I'm also delighted to confirm that my own hospital guidance and Thomas has started using Nu.Q NET in our first study. In a similar theme, we're trying to identify and track patients and monitor the severity of sepsis. This is a large study, we're aiming to enroll around 500 patients and compare patients with sepsis to healthy patients undergoing cardiac surgery. This should give us really good data to try and split the patients apart and understand differences between them. For those that might have missed the recent Edison webinar on sepsis or indeed their thematic report, I wanted to highlight a couple of ongoing studies, which we hope will continue to reinforce and strengthen our clinical utility case. We have ongoing analysis of two large retrospective sepsis cohorts in Europe. The first is with the German sepsis group and the second is with the team at UMC Amsterdam. In total, these studies will examine the outcome and trajectory of over 2,500 patients with sepsis. They involve the processing of over 8,000 Nu.Q NET samples. It's an unbelievably rich data source for us. And we're really excited about this data. But we're really excited about presenting it and submitting it for publication by the end of 2024. These studies will be a rich source of insight using Nu.Q NET on a really large scale and should enable us to sharpen and improve it as we move forward to again bringing into the clinical arena. Our project with key opinion leader, Professor De Carli Annan [ph] in France is progressing really well. De Carl is involved in the consortium project with an ongoing prospective study of which Volition is a member. Again, it's longitude in nature and large scale and is aiming to recruit 1,500 patients. We've also extended our study with [indiscernible] in the U.S. We have refocused this study to concentrate on the sickest patients admitted from the emergency room rather than simply including intensive care patients. This is expanding the population of patients in which we're using Nu.Q and that's really exciting. We hope to close out the study by the end of second quarter and we'll share the results as soon as we can. We're confident that we will have significantly strengthened our data within the confidential data room for ongoing commercial discussions by the middle of the year. From a publication perspective, all eyes and our focus will be on the European Society of Intensive Care meeting in October later this year. We anticipate a number of the studies I've just mentioned will report at ESICM. We're also really proud to be sponsoring our first satellite symposium session at the Congress. More details will follow, but it's going to be a really busy year ahead for Nu.Q NET and sepsis. I'd now like to take just a few more minutes to discuss Volition's potentially breakthrough cancer detection method, which we first presented at the European Society of Medical Oncology Congress Press in 2023. Cancer, as we all know, affects the lives of millions around the world each year. Unfortunately, the number of new cases of cancer diagnosed each year is continuing to grow. Like many diseases, early diagnosis when the cancer is smaller and hasn't spread leads to a better outcome for patients that's less surgery, less chemotherapy and just needs better and improved outcomes. Sadly, cancer is often a silent disease, it's asymptomatic and people don't realize they have it until really quite late. In the UK, we're a perfect example about that, where around 45% in cancers are diagnosed at the later stages Stage 3 and Stage 4. Our test focuses around detecting circulating tumor DNA, ctDNA. Detecting ctDNA is really difficult because the levels of DNA in blood are relatively low and circulating tumor DNA compromises only about 0.01% of the circulating cell-free DNA. While the challenge is compounded as most of the detect cancer DNA looks almost identical or is indeed exactly the same as normal DNA. Volition has developed a novel method of liquid biopsy involving the first reported physical isolation of tumor-derived DNA fragments from blood. The cancer-derived circulating tumor DNA fragments are then extracted after removal of all normal background DNA and then they are sequenced using a low-cost PCR test. We're calling this technique Capture-PCR. Volition's proof-of-concept data was presented at ESMA 2023, demonstrating the isolation of tumor-derived ctDNA fragments from plasma. Volition tested the new method in a small clinical experiment and detected a range of liquid and solid organ cancers, including early stage disease, Stage 1 disease. These early assays were developed from our initial leukemia model, but to our surprise, we were also able to detect many other cancers. In particular, we were able to detect colorectal cancer. We're really excited about the potential for Capture-PCR going forward. My colleague, Dr. Jake Micalle and team have presented a number of cancer specific conferences such as prostate cancer and liver cancer conferences. They have been sharing their data with important key opinion leaders and we've received really valuable feedback and positive feedback as we go forward. The team have also continued to identify other potential markers and other potential targets associated with the PCR test and we very much look forward to sharing this data in particular in solid organ cancers throughout this year and beyond. Last but certainly no means least, Jake is working hard on completing the manuscript to submit this breakthrough method for peer review publication. This is going to be incredibly important paper and is intrinsically aligned with Felicia's core ethos and purpose of bringing a low-cost diagnostic test to millions of people around the world. Understandably, there will be ongoing commercial discussions throughout the year. Enjoying to a close, and so I can hand back over to Cameron, I'd just like to take a moment and I hope it's come across from me talking here to express how personally excited I am to be joining the company. I really believe in Volition's ethos and purpose and I'll hand you back to Cameron for his closing remarks. Thank you ever so much.
Andrew Retter:非常感謝您的客氣話,湯姆,大家早安。首先,我想花一點時間感謝 Cameron、Jake 和董事會與我合作,並邀請我在如此重要的時刻加入 Volition 團隊。過去兩年我非常享受與 Volition 的合作,並且對於在未來幾年致力於實現我們的使命目標並為其做出貢獻感到非常興奮。我們真誠地希望能夠對改善全世界數百萬人的生活和生活品質產生影響。今天早上我想向您介紹我們在 Nu.Q NET 和我們新的突破性癌症檢測方法(現在稱為 Capture-PCR)方面取得的一些重大進展。首先,從 NETosis 和敗血症開始。正如您之前聽我說過的,膿毒症是全球主要死亡原因之一,每年有近 5000 萬例病例,約 1100 萬人死亡。 2023 年,醫生們在努力解決這些問題方面取得了重大進展,我只想回顧一下一些亮點。 9 月,Volition 在希臘雅典舉辦了關鍵意見領袖圓桌會議。研討會為期兩天,專門討論敗血症和 Nu.Q NET 的潛在作用,一些世界領先的專家參加了研討會。許多與會者都在我們的 Nu.Q NET 卓越中心計劃的保護下開展工作,並且現在擁有使用檢測的第一手經驗。該小組認為,Nu.Q NET 可能代表過去 30 年來膿毒症診斷和監測的最大突破之一。我們正在與這個小組一起推進,我現在正在撰寫一篇評論文章,打算在年底提交該文章進行同行評審並在期刊上發表。繼續發表主題,在我們的加拿大意見領袖活動後不久和十月季度末,我們的臨床卓越小組發表了第一篇臨床論文。 Gila Monterrey 教授在萊昂的團隊發表的數據證明了 Nu.Q NET 水平與敗血症的相關性。有明顯的死亡訊號。這意味著什麼?不幸的是,患者的 Nu.Q NET 水平越高,他們死亡的可能性就越大。我們也以縱向方式看到 Nu.Q NET 水平與患者疾病的嚴重程度密切相關。我們一直在使用敗血症評分(即序貫器官衰竭評估評分)來校準和檢查 Nu.Q NET 水平。很高興我們已經發表了第一篇論文,我真的很期待在 2024 年和 2025 年期間發布和與您分享來自我們卓越中心的更多數據。在美國,我很高興向您報告Volition 與美國食品和藥物管理局完成了Q 子流程。 FDA 已確認我們可以繼續遵循傳統的 5、10-K 途徑。我也很高興地確認我自己的醫院指導和 Thomas 已開始在我們的第一項研究中使用 Nu.Q NET。在類似的主題中,我們正在嘗試識別和追蹤患者並監測敗血症的嚴重程度。這是一項大型研究,我們的目標是招募約 500 名患者,並將敗血症患者與接受心臟手術的健康患者進行比較。這應該為我們提供非常好的數據來嘗試將患者分開並了解他們之間的差異。對於那些可能錯過了最近的愛迪生膿毒症網路研討會或其主題報告的人,我想重點介紹幾項正在進行的研究,我們希望這些研究將繼續加強和加強我們的臨床實用案例。我們正在對歐洲的兩個大型回顧性敗血症隊列進行分析。第一個是與德國膿毒症小組合作,第二個是與 UMC 阿姆斯特丹團隊合作。總的來說,這些研究將檢查 2,500 多名膿毒症患者的結果和軌跡。它們涉及超過 8,000 個 Nu.Q NET 樣本的處理。對我們來說,這是一個令人難以置信的豐富資料來源。我們對這些數據感到非常興奮。但我們非常高興能夠在 2024 年底之前展示它並提交出版。這些研究將成為大規模使用 Nu.Q NET 的豐富見解來源,並且應該使我們能夠在我們的研究過程中不斷完善和改進它。再次邁向臨床領域。我們與法國關鍵意見領袖 De Carli Annan 教授的專案進展非常順利。 De Carl 參與了該聯盟項目,正在進行一項前瞻性研究,Volition 是該項目的成員。同樣,它的性質是經度和大規模的,目標是招募 1,500 名患者。我們也在美國擴展了我們的研究[音頻不清晰]。我們重新調整了這項研究的重點,將重點放在從急診室收治的病情最嚴重的患者,而不是簡單地包括重症監護患者。這擴大了我們使用 Nu.Q 的患者群體,這確實令人興奮。我們希望在第二季末之前完成這項研究,我們將盡快分享結果。我們相信,到今年年中,我們將大幅增強機密數據室內的數據,以便進行持續的商業討論。從出版的角度來看,所有的目光和我們的焦點將集中在今年 10 月稍後舉行的歐洲重症監護學會會議上。我們預計我剛才提到的一些研究將在 ESICM 上報告。我們也非常自豪能夠在大會上贊助我們的第一屆衛星研討會。更多細節將隨之而來,但對於 Nu.Q NET 和敗血症來說,未來的一年將是非常忙碌的一年。我現在想再花幾分鐘討論 Volition 潛在突破性的癌症檢測方法,該方法是我們於 2023 年在歐洲腫瘤內科學會大會出版社首次提出的。眾所周知,癌症影響著數百萬人的生活每年的世界。不幸的是,每年診斷出的新癌症病例數仍在持續增加。與許多疾病一樣,當癌症較小且尚未擴散時進行早期診斷可以為患者帶來更好的結果,減少手術、化療,只需要更好和改善的結果。可悲的是,癌症通常是一種無聲的疾病,它沒有症狀,人們直到很晚才意識到自己患有這種疾病。在英國,我們就是一個完美的例子,大約 45% 的癌症是在第三階段和第四階段的晚期階段被診斷出來的。我們的測試重點是檢測循環腫瘤 DNA,ctDNA。檢測 ctDNA 確實很困難,因為血液中的 DNA 水平相對較低,循環腫瘤 DNA 只佔循環遊離 DNA 的約 0.01%。然而,由於大多數檢測到的癌症 DNA 看起來與正常 DNA 幾乎相同或實際上完全相同,因此挑戰變得更加複雜。 Volition 開發了一種新的液體活檢方法,首次報告了從血液中物理分離腫瘤來源的 DNA 片段。去除所有正常背景 DNA 後,提取源自癌症的循環腫瘤 DNA 片段,然後使用低成本 PCR 測試進行定序。我們將這種技術稱為「Capture-PCR」。 Volition 的概念驗證數據已在 ESMA 2023 上展示,證明了從血漿中分離腫瘤來源的 ctDNA 片段。 Volition 在一項小型臨床實驗中測試了這種新方法,並檢測了一系列液體和固體器官癌症,包括早期疾病、第一期疾病。這些早期檢測方法是根據我們最初的白血病模型開發的,但令我們驚訝的是,我們也能夠檢測到許多其他癌症。特別是,我們能夠檢測出大腸直腸癌。我們對 Capture-PCR 的未來潛力感到非常興奮。我的同事 Jake Micalle 博士和團隊在許多癌症特定會議上發表了演講,例如前列腺癌和肝癌會議。他們一直在與重要的關鍵意見領袖分享他們的數據,在我們前進的過程中,我們收到了非常有價值的回饋和正面的回饋。團隊也繼續確定與 PCR 測試相關的其他潛在標記物和其他潛在目標,我們非常期待在今年及以後分享這些數據,特別是實體器官癌症的數據。最後但同樣重要的是,傑克正在努力完成手稿,以提交這一突破性方法以供同行評審出版。這將是一篇極其重要的論文,本質上符合 Felicia 的核心精神和為世界各地數百萬人提供低成本診斷測試的目的。可以理解的是,全年都會有持續的商業討論。愉快的結束了,所以我可以把時間交還給卡梅倫,我想花一點時間,希望我在這裡講話能表達我個人對加入公司的興奮之情。我真的相信 Volition 的精神和宗旨,我會將您交還給卡梅倫,讓您聽他的結束語。真的非常感謝你。
Cameron Reynolds: Thanks very much, Andy, for providing those insights, and thanks as always to Terry and Tom for their reports. It is a real sign of the varied expertise we now have at Volition. 2023 was certainly transformational for Volition and a year we can look back on with pride. The commercialization of our transformational Nu.Q vet cancer test within the companion animal healthcare sector has led to agreements with several new global and regional partners, including last week with Fujifilm Vet Systems, Japan's leading veterinary diagnostic service provider and looking just around the corner, the Nu.Q vet cancer test will soon be available as an in-house diagnostic test through Heska and Antech company. We strongly suspect we will see very good revenue growth from Nu.Q vet through 2024 and beyond. I'm also absolutely delighted in the progress made in our Nu.Q NET's pillar, and in particular, in determining our regulatory pathway forward with the U.S. FDA, a key milestone for the company and in having a number of large-scale clinical studies due for publication later this year. Thirdly, and as we always seem to run low on time, I won't cover too much, but I would like to quickly mention Nu.Q Discover, which recorded revenue of $300,000 in 2023 and now has a pipeline of projects valued at over $1 million As a reminder, Nu.Q Discover is a complete solution to profiling nucleosomes, drug developers and scientists can work with us, access our state-of-the-art proprietary assays and realize their long term drug development needs. In this way, Nu.Q Discover is able to unlock value from Volition's IP portfolio by helping us commercialize the areas we are not going to focus on ourselves. As I mentioned, revenue in 2023 was $300,000 and we expect it to more than double in 2024 and be as profitable as early as 2025. And finally, I'm absolutely also delighted with our potential breakthrough CTCF cancer detection method, Capture-PCR, which we had a poster in the Q4 at ESMO. We believe this is a true breakthrough moment. The first reported physical isolation of a class of tumor derived cell free DNA fragments from blood. We expect that this method obviates expensive and time-consuming DNA sequencing and bioinformatics, allowing for a rapid cost-effective detection in a routine blood test. This method could become a must have technology. Given its significance, we are very much open to licensing this technology. We have been tremendously encouraged by the level of interest thus far. It has been and will continue to be a busy few months ahead of discussions and negotiations, not only now on Capture-PCR, but as we build out the data room for Nu.Q NET through the second quarter of this year, we anticipate more active discussions on that front as well. It is an exciting time for us as a Company and we look forward to sharing further updates and milestones with you over the coming quarters as we continue to adapt such changing times and conditions, deliver on what we believe to be revolutionary technologies. Given the current macroeconomic conditions, we are focusing on getting each pillar to support itself, either through product revenues, milestone payments, out licensing, or other non-dilutive funding in the coming year. We are making every attempt to ensure as little dilution as possible to reach breakeven as a company with a mix of non-dilutive funding, revenue and milestone payments from our licensing as we have achieved in Vet. As we've described before, we are currently targeting the following. Firstly, we expect Nu.Q vet to be overall cash positive from existing milestone payments and the expected revenue ramp as more partners launch and existing partners expand into new territories. We're also working on a range of new products to drive revenue growth and hopefully new out licensing and milestone payments in future years from Vet. Secondly, we expect Nu.Q Discover to more than double revenue in 2024 and to become profitable as a unit starting in 2025, with over $1 million in the current pipeline and growing strongly. Thirdly, we have begun the strategy to fund, as Terig alluded to earlier, our Nu.Q net pillar through non-dilutive and or project funding with an aim of $25 million. We have targeted a range of governmental agencies and are also preparing the background work aimed at attracting a large player to either out license or invest in this product directly. We have made strong progress through the first quarter of 2024 in getting the data required, and our aim is to get the first payments in the next 12 months from either corporate or governmental sources. Lastly, as discussed by Gael Forterre, our Chief Commercialization Officer in our recent webinar, there has been a lot of external interest in our CTCF and Nu.Q cancer technologies. Our strategy is to license this out to one or more large companies as a commercial undertaking of this size is likely beyond our current capabilities. If successful, we believe this strategy could provide us with ongoing royalties and very meaningful milestone payments in the next 12 months. In drawing to a close, I would like to thank you all for joining the call today. We very much appreciate it, given how much there is to digest across all of our pillars. We are now happy to answer questions. Operator?
卡梅倫雷諾茲:非常感謝安迪提供這些見解,並一如既往地感謝特里和湯姆的報告。這是我們 Volition 目前擁有的各種專業知識的真實標誌。 2023 年對 Volition 來說無疑是變革性的一年,我們可以自豪地回顧這一年。我們的變革性Nu.Q 獸醫癌症測試在伴侶動物醫療保健領域的商業化已導致與多個新的全球和區域合作夥伴達成協議,包括上週與日本領先的獸醫診斷服務提供商Fujifilm Vet Systems 達成的協議,並且指日可待, Nu.Q 獸醫癌症測試很快將通過 Heska 和 Antech 公司作為內部診斷測試提供。我們強烈懷疑,到 2024 年及以後,我們將看到 Nu.Q vet 的營收成長非常好。我也對我們的 Nu.Q NET 支柱取得的進展感到非常高興,特別是在確定我們與美國 FDA 的監管路徑方面,這是公司的關鍵里程碑,並且進行了許多大規模臨床研究將於今年晚有些時候出版。第三,由於我們的時間似乎總是不夠,我不會介紹太多,但我想快速提一下 Nu.Q Discover,該公司在 2023 年的收入為 30 萬美元,現在擁有價值超過 30 萬美元的項目管道100 萬美元提醒一下,Nu.Q Discover 是分析核小體的完整解決方案,藥物開發人員和科學家可以與我們合作,訪問我們最先進的專有檢測方法並實現他們的長期藥物開發需求。透過這種方式,Nu.Q Discover 能夠幫助我們將我們不關注的領域商業化,從而釋放 Volition 智慧財產權組合的價值。正如我所提到的,2023 年的收入為30 萬美元,我們預計2024 年將增加一倍以上,並最早在2025 年實現盈利。最後,我對我們潛在的突破性CTCF 癌症檢測方法Capture-PCR 感到非常高興,我們在 ESMO 第四季有一張海報。我們相信這是一個真正的突破時刻。首次報告從血液中物理分離出一類腫瘤來源的無細胞 DNA 片段。我們希望這種方法能夠避免昂貴且耗時的 DNA 定序和生物資訊學,從而能夠在常規血液檢測中進行快速且經濟高效的檢測。這種方法可能成為一項必備技術。鑑於其重要性,我們非常願意授權這項技術。到目前為止,我們對人們的興趣程度感到極大鼓舞。在討論和談判之前的幾個月裡,我們已經並將繼續忙碌,不僅是在 Capture-PCR 方面,而且隨著我們在今年第二季度為 Nu.Q NET 建立數據室,我們預計會有更多在這方面也進行了積極的討論。對於我們公司來說,這是一個令人興奮的時刻,我們期待在未來幾季與您分享進一步的更新和里程碑,因為我們將繼續適應不斷變化的時代和條件,交付我們認為是革命性的技術。鑑於當前的宏觀經濟狀況,我們的重點是讓每個支柱在來年透過產品收入、里程碑付款、許可或其他非稀釋性資金來支持自身。我們正在盡一切努力確保盡可能少的稀釋,以實現盈虧平衡,作為一家公司,透過我們的許可獲得非稀釋性資金、收入和里程碑付款,就像我們在 Vet 中所實現的那樣。正如我們之前所描述的,我們目前的目標如下。首先,隨著更多合作夥伴的推出以及現有合作夥伴擴展到新領域,我們預計 Nu.Q vet 將從現有的里程碑付款和預期收入成長中獲得整體現金收益。我們也致力於開發一系列新產品,以推動營收成長,並希望在未來幾年從 Vet 獲得新的授權和里程碑付款。其次,我們預計 Nu.Q Discover 的營收將在 2024 年增加一倍以上,並從 2025 年開始作為一個部門實現盈利,目前的收入超過 100 萬美元,並且增長強勁。第三,正如 Terig 之前提到的,我們已經開始透過非稀釋性和/或專案融資為我們的 Nu.Q 淨支柱提供資金的策略,目標是 2500 萬美元。我們已針對一系列政府機構,並正在準備旨在吸引大型參與者直接投資該產品的背景工作。截至 2024 年第一季度,我們在獲取所需數據方面取得了巨大進展,我們的目標是在未來 12 個月內從企業或政府來源獲得第一筆付款。最後,正如我們的首席商業化官 Gael Forterre 在最近的網路研討會上所討論的,外部對我們的 CTCF 和 Nu.Q 癌症技術非常感興趣。我們的策略是將其授權給一家或多家大公司,因為這種規模的商業企業可能超出了我們目前的能力。如果成功,我們相信這項策略可以在未來 12 個月內為我們提供持續的特許權使用費和非常有意義的里程碑付款。最後,我要感謝大家參加今天的電話會議。考慮到我們所有的支柱都有很多東西需要消化,我們對此非常感激。我們現在很樂意回答問題。操作員?
Operator: [Operator Instructions]. Our first question is from Tim Moore with EF. Tim, please proceed.
操作員:[操作員指令]。我們的第一個問題來自 EF 的 Tim Moore。提姆,請繼續。
Tim Moore: Thank you. That was very informative prepared remarks. It was nice to hear that there's a lot of different levers being pulled and good optionality. Maybe I just want to start out with IDEXX. You mentioned there were revenues, it sounds like the end of the year that could start to come through. I'm just kind of wondering if you can talk a little bit about, it seems like have they finally finished kind of getting their standard operating procedures and best practices in place for the marketing launch? And if you can remind me, is it something like $10 per kit you're getting on those because you're assembling the full kit and shipping them?
提姆摩爾:謝謝。這是準備好的、內容豐富的發言。很高興聽到有很多不同的槓桿被拉動並且有很好的選擇性。也許我只是想從 IDEXX 開始。你提到有收入,聽起來今年底可能會開始實現。我只是想知道您是否可以談談,他們似乎終於完成了為行銷啟動制定標準作業程序和最佳實踐的工作?如果您能提醒我,您是否會因為組裝完整的套件並運送它們而獲得每個套件 10 美元的費用?
Cameron Reynolds: Yes, yes, it is. That's correct. So yes, IDEXX have been great partners for the last year and a half and I think that we're putting a lot of work into really try to get the sales growing. So, I think there's an absolutely huge need for the test worldwide. And certainly, to get to where we need to get to, there's had to be some education of the customers. It's a completely disruptive technology. So, when it comes into the market, it's obviously a whole new thing for the vets as well as for the company. And so, we've been working closely with them to really get sales moving. And I think as it was mentioned several times, there were 58,000 tests this last year sold, so we sold the components for. So, it's getting adoption and obviously it's a very disruptive test. And I think also when the new platform comes through, which is actually starting on the first of next month, having it available in the lab as well as a point of care, I think will be absolutely huge to getting adoption out there. I think the more groups out there selling it whether that's IDEXX or Heska or Fuji, it really helps to generate awareness and education and getting vets used to a disruptive new technology. As we discussed, there's been nothing available in the cancer space before. So yes, and $10 a test is correct.
卡梅倫·雷諾茲:是的,是的,確實如此。這是正確的。所以,是的,IDEXX 在過去的一年半裡一直是很好的合作夥伴,我認為我們正在投入大量工作來真正嘗試讓銷售額成長。所以,我認為全世界對測驗的需求絕對巨大。當然,為了達到我們需要達到的目標,必須對客戶進行一些教育。這是一項完全顛覆性的技術。因此,當它進入市場時,對於獸醫和公司來說顯然都是一個全新的事物。因此,我們一直與他們密切合作,以真正推動銷售。我認為正如多次提到的那樣,去年售出 58,000 次測試,因此我們出售了組件。因此,它正在被採用,顯然這是一個非常顛覆性的測試。我還認為,當新平台推出時(實際上將於下個月一號開始),在實驗室和護理點提供該平台,我認為對於推廣應用來說絕對是巨大的。我認為越多的團體出售它,無論是 IDEXX、Heska 還是 Fuji,它確實有助於提高認識和教育,並讓獸醫習慣顛覆性的新技術。正如我們所討論的,之前在癌症領域還沒有任何可用的東西。所以是的,一次測試 10 美元是正確的。
Tim Moore: Thanks for that really good Japan Fujifilm Vet Systems update. That was terrific news. And actually, I had a question about feline tests. Do you think that's still maybe on track to launch maybe late this year? And when would you think you would receive the $5 million milestone payment timing?
提姆摩爾:感謝日本 Fujifilm Vet Systems 的精彩更新。這是個好消息。事實上,我有一個關於貓科動物測試的問題。您認為該產品仍有可能在今年稍後推出嗎?您認為您什麼時候會收到 500 萬美元的里程碑付款?
Cameron Reynolds: Good question. and the first point, Fuji have done a huge amount of work before the launch. They're very organized. They're the biggest vet company in Japan. There's 60,000 vets in Japan and 12,000 fed hospitals. I didn't realize it was that big a market. It's obviously a large country and quite a rich country. So, as you probably heard from Tom and the team, the enthusiasm from the vet conference there has been very large. So, it's extremely good to get enthusiasm coming through and have a good new market. Yes, so the feline five we've been doing some work on with a range of other products looking to launch in the vet space. We're looking to get it working in cat 5th year. So, it's certainly possible this year or in the first half of next year that that payment will be made. As we talked about, an overall part of our strategy is to get as much funding as we can from non-dilutive and milestones and that would be the last of the payments due to us from Heska, the 23 million we've got so far plus this 5 million. So yes, it's definitely still in process and it's a reasonable thing to still have on the books.
卡梅倫雷諾茲:好問題。而第一點,富士在推出前就做了大量的工作。他們很有組織性。他們是日本最大的獸醫公司。日本有 6 萬名獸醫和 12,000 家醫院。我沒想到市場這麼大。這顯然是一個大國,也是一個相當富裕的國家。因此,正如您可能從湯姆和團隊那裡聽到的那樣,獸醫會議的熱情非常高。因此,獲得熱情並擁有良好的新市場是非常好的。是的,所以我們一直在與一系列其他產品一起開發貓科五種產品,希望在獸醫領域推出。我們希望在第五年讓它發揮作用。因此,這筆款項肯定有可能在今年或明年上半年支付。正如我們所討論的,我們策略的總體部分是從非稀釋性和里程碑中獲得盡可能多的資金,這將是 Heska 應付給我們的最後一筆付款,迄今為止我們已收到 2300 萬美元再加上這500萬。所以是的,它肯定仍在進行中,並且仍然保留在帳本上是合理的事情。
Tim Moore: My last set of questions is tied to sepsis. I mean, such a huge catalyst, gigantic market, number one killer in the hospitals. So, you have talked before about the traditional, 5, 10-K regulatory pathway. And if you can remind me, you're trying to demonstrate substantially equivalent performance and characteristics of a device already at the FDA cleared in the U.S., right? Can you can you kind of walk us through that? And I know it's theoretical, but what is the time line? I get a lot of questions from investors about, when do you think, if it does work out and you get approved, when do you think you can maybe start achieving revenues on the sepsis side?
提姆摩爾:我的最後一組問題與敗血症有關。我的意思是,如此巨大的催化劑,巨大的市場,醫院的頭號殺手。所以,您之前談到了傳統的 5、10-K 監管途徑。如果您能提醒我,您正試圖證明已在美國 FDA 批准的設備具有基本相同的性能和特性,對嗎?您能引導我們完成這個過程嗎?我知道這是理論上的,但時間線是多少?我從投資者那裡收到了很多問題,你認為,如果它確實有效並且獲得批准,你認為什麼時候可以開始在敗血症方面實現收入?
Cameron Reynolds: Very good question. So, there's obviously, it's a product which has shown tremendous promise as you said. And the two things we've proven so far, what publications have shown, that's closely correlated with intensive care mortality and sepsis score, which is obviously both of which is incredibly important. As we talked about, there's a range of studies we're doing now, which will put a mountain of data, an avalanche of data coming out in thousands and thousands of patients and tens of thousands of samples beginning this month and all the way through the rest of the year with a big crescendo kind of in June. They're looking to show correlation with the sepsis III score, which sepsis is now defined as a dysregulated immune response, which is exactly what we measure. So, it's actually obviously incredibly useful. Disease severity, correlation with 28-day mortality, the duration of organ support and the length of stay in hospital. So, all of those are incredibly important to the clinician, which I think is why Andy and all the other clinicians we've been working with are so keen on them. With regards to the exact 510(k) pass, probably best get it from Andy. He was the key person in those trials. I don't want to make a mistake on that. There are quite a few predictive products, none of which measure what we measure, but there are products which have the ability to do some of this. That's why we were very lucky to get the 510(k) pass and I'm sure he can outline. I think he might be available on some later calls to go through the predicates as they were discussed. But that is something we're incredibly excited about. And I think it's if it continues to go well and every bit of day we've seen so far has been outstanding. And because the test is low cost can be run on any platform, it could be a bedside test, it can be a lab test, it could be a lateral flow test and doing it through a 510(k), which is as you know is the easier path through the FDA is very important. Now as to timing, obviously we're doing everything we can to preserve cash. So, we're working with large governmental agencies to see if they can take a large part of the funding in the U.S. as well as Europe. We're also getting the data ready so that we can get industry partners involved. So that's coming to a head in June when we'll start to open up a data room to look to get as much funded as possible from outside sources. For obvious reasons, the market is what it is at the moment, so we're doing everything we can not to spend money. And after that, our product would be at least a couple of years. But don't forget, our model has always been to make as much money as we can from licensing and upfront milestone payments. In the last two years, we've got 23 million just from Heska alone, which is obviously very, very meaningful in what we do. So, I wouldn't just think of it as revenue which is obviously a few years away, but as we have invested getting large chunks of money in the meantime from large industry partners and/or government agencies and I think there's certainly our aim and I think it's a very reasonable chance that we'll get some licensing or milestone revenues from either or both transcription factors and the sepsis side in the next 12 months. And if you look at the level of payments we've got in the vet side, it's a very important test in the vet. But I think the Nu.Q NET test is a whole level of importance for humanity. So, we'd be expecting some very significant payments in that sort of timescale. Does that answer your question?
卡梅倫·雷諾茲:非常好的問題。所以,很明顯,正如你所說,這是一種顯示出巨大前景的產品。到目前為止,我們已經證明的兩件事,即出版物所表明的,與重症監護死亡率和膿毒症評分密切相關,這顯然兩者都非常重要。正如我們所說,我們現在正在進行一系列研究,從本月開始一直到整個過程,我們都會收集大量數據,來自成千上萬名患者和數以萬計的樣本。今年剩下的時間裡,六月會出現一個大的漸強。他們希望顯示與敗血症 III 評分的相關性,敗血症現在被定義為免疫反應失調,而這正是我們所測量的。所以,它實際上顯然非常有用。疾病嚴重程度、與 28 天死亡率、器官支持持續時間和住院時間的相關性。因此,所有這些對臨床醫生來說都非常重要,我認為這就是為什麼安迪和我們合作過的所有其他臨床醫生都對它們如此熱衷。關於確切的 510(k) 通行證,可能最好從 Andy 那裡獲得。他是那些試驗的關鍵人物。我不想在這一點上犯錯。有相當多的預測產品,它們都不能衡量我們所衡量的內容,但有些產品有能力做到其中一些。這就是為什麼我們非常幸運地獲得了 510(k) 通行證,我相信他可以概述一下。我認為他可能會在以後的一些電話中檢查所討論的謂詞。但這是我們非常興奮的事情。我認為,如果一切繼續順利,並且迄今為止我們所看到的每一天都非常出色的話。而且由於該測試成本低廉,可以在任何平台上運行,它可以是床邊測試,可以是實驗室測試,也可以是側流測試並通過 510(k) 進行,正如您所知通過FDA 的更簡單途徑非常重要。至於時機,顯然我們正在盡一切努力保存現金。因此,我們正在與大型政府機構合作,看看他們是否可以在美國和歐洲獲得大部分資金。我們也正在準備數據,以便讓產業合作夥伴參與其中。因此,到了六月份,這個問題就到了緊要關頭,屆時我們將開始開放一個資料室,以尋求從外部來源獲得盡可能多的資金。出於顯而易見的原因,市場就是目前的情況,所以我們正在盡一切努力不花錢。在那之後,我們的產品將至少存在幾年。但不要忘記,我們的模式一直是從許可和預付款中賺取盡可能多的錢。在過去的兩年裡,我們僅從 Heska 就獲得了 2300 萬美元,這對我們所做的事情顯然非常非常有意義。因此,我不會僅僅將其視為顯然需要幾年時間的收入,但由於我們同時從大型行業合作夥伴和/或政府機構那裡獲得了大量資金,我認為這肯定是我們的目標和目標我認為這是一個非常合理的機會,我們將在未來12 個月內從轉錄因子和敗血症方面中的一個或兩個獲得一些許可或里程碑收入。如果你看看我們在獸醫方面的支付水平,你會發現這是對獸醫的一個非常重要的測試。但我認為 Nu.Q NET 測試對於人類來說具有整體重要性。因此,我們預計在這樣的時間內會收到一些非常大的付款。這是否回答你的問題?
Tim Moore: It does, it does. It's terrific color and granularity. And I have one last little related topic question. You kind of already addressed this. There could be potential for project financing. You can come from the corporate rev, government, both milestones. One question I get from investors a lot was, as things go well on the vet side and maybe that becomes positive free cash flow and self-funding two years from now, hopefully. Would you consider divesting the vet side or spinning it out to maybe cash flow fund the human sepsis trials?
提姆摩爾:確實如此,確實如此。它的顏色和顆粒度都很棒。我還有最後一個相關主題的小問題。你已經解決了這個問題。可能存在專案融資的潛力。你可以來自公司牧師、政府,這兩個里程碑。我經常從投資者那裡得到的一個問題是,隨著獸醫方面的進展順利,也許兩年後會變成正的自由現金流和自籌資金。您會考慮剝離獸醫部門或將其分拆出來,為人類敗血症試驗提供現金流資金嗎?
Cameron Reynolds: Yes, absolutely. So obviously, at the moment, it is actually not from revenue because you've seen what that is, but from the milestone payments and the other payments we're getting, it's actually cash flow positive at the moment from all those other payments. $23 million obviously has been a lot from those sides. Yes, we would absolutely look to corporatize and then have it run as a separate entity, because this is just the very first test on what should be a very long pathway of products we can launch in the vet space. We mentioned feline as well. Obviously, sepsis happens in dogs and every other animal as it does in humans. And also, the human transcription factor work, we have every reason to believe it would work in animals just as well as humans and then all the other animals. So, I think going forward, our business model has been very much to develop the technology and then prove it works, get a product launch like we have in vet, like we're about to in NETosis and then make revenue from licensing it out. But I think the final step on that path would be to make it to the vet itself. And I think that's something which could well happen in the next couple of years. And actually, there's obviously been some interest from other groups. We're the only cancer detection company out there at the moment which has a product in the market. So, I think it's going to be a very attractive one. But we want to get that value curve kind of pushed up the curve by pruning felines and/or sepsis and/or transcription factors in the next 12 months. So, it's probably a two-year target for that.
卡梅倫·雷諾茲:是的,絕對是如此。顯然,目前它實際上不是來自收入,因為你已經看到了收入是什麼,但從里程碑付款和我們收到的其他付款來看,目前所有其他付款實際上都是正現金流。 2300 萬美元對於雙方而言顯然是一筆巨款。是的,我們絕對會尋求公司化,然後將其作為一個獨立的實體運行,因為這只是我們在獸醫領域推出的產品的第一個測試,這應該是一個很長的產品路徑。我們也提到了貓科動物。顯然,敗血症發生在狗和其他所有動物身上,就像發生在人類身上一樣。而且,人類轉錄因子起作用,我們有充分的理由相信它對動物也起作用,就像人類一樣,然後是所有其他動物。所以,我認為展望未來,我們的商業模式主要是開發技術,然後證明它的有效性,像我們在 vet 中那樣推出產品,就像我們在 NETosis 中那樣,然後透過授權獲得收入。但我認為這條道路的最後一步是去看獸醫。我認為這很可能在未來幾年內發生。事實上,其他團體顯然也對此感興趣。我們是目前市面上唯一擁有產品的癌症檢測公司。所以,我認為這將是一個非常有吸引力的。但我們希望透過在未來 12 個月內修剪貓科動物和/或敗血症和/或轉錄因子來推高價值曲線。因此,這可能是兩年目標。
Operator: Our next question is from Ilya Zubkov with Freedom Broker. Please proceed.
接線生:我們的下一個問題來自 Freedom Broker 的 Ilya Zubkov。請繼續。
Ilya Zubkov: Good morning, and congrats for the progress in Q4. I have a question on the oncology test. Talking about Capture-PCR technology, what types of cancer are currently considered as the most promising for detection according to studies and your expectation?
Ilya Zubkov:早安,恭喜第四季的進展。我有一個關於腫瘤學測試的問題。談到Capture-PCR技術,根據研究和您的期望,目前哪些類型的癌症被認為最有希望檢測?
Cameron Reynolds: That’s a very good question. So, transcription factors are actually indicative of all types of cancer because, they are, it's an epigenetic signal, which is in all the cancers. So, we've done some work in a varied range of cancers, including lung and colorectal and the blood cancers. And initially, we'll focus on the larger cancers, the more prevalent ones particularly, of course, like we have in the past, in lung and colorectal and the blood cancers because that's where we did the first work. But it certainly holds the promise of -- it's definitely going to be low cost, very easy to run, as easy to run as a proven test in blood, but certainly potential for every single type of cancer. But you would probably not develop a test for every single type of cancer. You'd probably develop the top five types or seven types, which between them account for the majority of cancer cases.
卡梅倫雷諾茲:這是一個非常好的問題。因此,轉錄因子實際上預示著所有類型的癌症,因為它們是一種表觀遺傳訊號,存在於所有癌症中。因此,我們在多種癌症方面做了一些工作,包括肺癌、大腸癌和血癌。最初,我們將重點關注較大的癌症、更常見的癌症,當然,就像我們過去所做的那樣,在肺癌、大腸癌和血癌中,因為這是我們進行第一項工作的領域。但它確實具有這樣的前景——它肯定成本低廉,非常容易運行,就像經過驗證的血液測試一樣容易運行,而且肯定對每種類型的癌症都有潛力。但您可能不會為每種類型的癌症開發一種測試方法。您可能會發現前五種或七種類型,它們佔癌症病例的大多數。
Ilya Zubkov: Thank you. That's helpful. And one more from me. The case test has demonstrated strong sensitivity in leukemia detection. And I'm wondering has any progress been made in its diagnostic performance for detection of solid tumors since October last year? And do you see the opportunity for improvement?
伊利亞·祖布科夫:謝謝。這很有幫助。還有我的另一封信。病例試驗顯示了白血病檢測的高度敏感性。我想知道自去年10月以來,其實體腫瘤檢測的診斷效能有什麼進展嗎?您是否看到了改進的機會?
Cameron Reynolds: Do you mean any in solid tumors with capture PCR?
Cameron Reynolds:您是指採用捕捉 PCR 技術治療實體腫瘤嗎?
Ilya Zubkov: Yes.
伊利亞·祖布科夫:是的。
Cameron Reynolds: Yes. We've done a lot of work. The first thing we've been doing has been optimizing the process to make it as quick as easy as possible and on discovery on a wide range of different targets. So yes, we've been making progress. I think Andy alluded to a paper that's in process of being published and also to make the process as quickly -- the process we announced was a prototype. We've been developing as much as we can to make it quicker, easier and cheaper and also on a broad range of solid tumors as well as the liquid tumor. And yes, we're making very good progress, and we're aiming to publish in the next few or submit it soon in the next few months and also work heavily on out-licensing. We've discussed several times on public calls that we think is a complete breakthrough. And if we continue to show selection or concentration of tumor-derived DNA it's going to have to be a must-have for anyone in the liquid biopsy business. So, we've been very pleasantly surprised with the level of excitement and the interest from a range of driven groups. And those active discussions are going on as well. And we expect to have some news on that in the coming months and quarters as well because again, we want to license it out and get upfront payments as well as a share of the upside going forward. So, expect to keep an eye on all of that in the next few months and the next few quarters.
卡梅倫雷諾茲:是的。我們已經做了很多工作。我們所做的第一件事就是優化流程,使其盡可能快速、簡單,並在廣泛的不同目標上進行發現。所以是的,我們一直在取得進展。我認為安迪提到了一篇正在發表的論文,也是為了盡快完成這個過程——我們宣布的過程是一個原型。我們一直在盡可能地進行開發,使其更快、更容易、更便宜,並且適用於廣泛的實體腫瘤和液體腫瘤。是的,我們正在取得非常好的進展,我們的目標是在接下來的幾年內發布或在接下來的幾個月內很快提交,並且還在對外許可方面進行了大量工作。我們已經在公開電話中討論過多次,我們認為這是一個徹底的突破。如果我們繼續展示腫瘤來源 DNA 的選擇或濃縮,它將成為液體活檢行業任何人的必備品。因此,我們對一系列受驅動團體的興奮程度和興趣感到非常驚訝。這些積極的討論也正在進行中。我們預計在未來幾個月和幾個季度也會有一些相關消息,因為我們再次希望獲得許可並獲得預付款以及未來收益的份額。因此,預計在接下來的幾個月和接下來的幾個季度中密切關注所有這些。
Louise Batchelor: Yes. And Cameron, if I can just ask, this is Lou actually here, I can just add. we've also presented at a number of conferences this year cancer-specific conferences. So, we've been at a prostate cancer conference, liver cancer conference and then just this last weekend, a lung cancer conference with cancer-specific posters with the CTC, capture PCR technology. And we've then got breast and CRC to come in the second quarter. So there has been some additional data presented and then we've got some as come and says further down the line with the Generation two.
路易絲‧巴徹勒:是的。卡梅倫,如果我可以問一下,這是盧,我可以補充。今年我們也在許多會議上介紹了癌症專題會議。所以,我們參加了前列腺癌會議、肝癌會議,然後就在上週末,我們參加了肺癌會議,其中有 CTC 的癌症特異性海報,捕捉 PCR 技術。然後我們將在第二季推出乳癌和大腸癌。因此,我們提供了一些額外的數據,然後我們得到了一些數據,並進一步說明了第二代的情況。
Operator: Our next question is from Bruce Jackson with the Benchmark Company. Please proceed.
接線生:我們的下一個問題來自 Benchmark 公司的 Bruce Jackson。請繼續。
Bruce Jackson: Hi, good morning, and thanks for taking my question. So, my first question is for Andrew. With the 500-patient study that you've just initiated is could that be ready in time for the conference in October?
布魯斯傑克森:嗨,早安,感謝您提出我的問題。所以,我的第一個問題是問安德魯的。您剛啟動的 500 名患者研究能否及時為 10 月的會議做好準備?
Cameron Reynolds: I'm sorry, Andy, is actually don't answer a question but he's in clinic.
卡梅倫雷諾茲:我很抱歉,安迪,實際上沒有回答問題,但他在診所。
Louise Batchelor: Just important into clinic. The full study won't have been finished Bruce by over this year, but we are hoping that we might potentially have some interim analyses available but we will have the results from several large-scale studies that will be presented at the October conference. So, the UMC in Amsterdam study and also the German Sepsis Group Study will be presented in October. But potentially, there might just be an interim analysis of hepatitis.
Louise Batchelor:對臨床來說很重要。完整的研究布魯斯今年還沒有完成,但我們希望我們可能有一些可用的中期分析,但我們將獲得幾項大規模研究的結果,這些結果將在十月的會議上公佈。因此,UMC 阿姆斯特丹研究以及德國敗血症組研究將於 10 月推出。但有可能,可能只是對肝炎進行中期分析。
Cameron Reynolds: One is the perspective, Bruce, so the retrospective ones, UMC Amsterdam and the German study will be presented, we believe, but not the perspective that will be a bit slower, of course.
卡梅倫·雷諾茲:布魯斯,一個是視角,所以我們相信,回顧性的、阿姆斯特丹大學醫學中心和德國研究將被呈現,但當然不是會慢一點的視角。
Bruce Jackson: Okay. And then a question on the burn rate. Is it going to stay where it was last year, roughly? How is that going to develop over the course of this year and 2025.
布魯斯傑克森:好的。然後是關於燃燒率的問題。大概會維持去年的水準嗎?從今年到 2025 年,這種情況將如何發展?
Cameron Reynolds: Terig?
卡梅倫雷諾茲:特里格?
Terig Hughes: Good question. Bruce. So, as we mentioned just now, we ended the year with cash of $20.7 million in the bank. And we used net cash in operating activities last year of $18.1 million. So that was partly offset -- or costs were partly offset by the $13 million that we received in licensing fees last year. And what we can expect is that our costs this year will be slightly lower than they were last year. And that's partly the result of the cost-saving actions that we took at the back end of last year saving a little over $2 million on a full year basis. And our focus this year is on achieving our next licensing deals in the human space, as Cameron mentioned. So, we've also initiated efforts with respect to seeking nondilutive funding in the U.S. And again, as Cameron mentioned, we're looking at getting each leg to support itself. What we're focusing on is bringing in those licensing deal so that we can achieve upfront payments and milestone payments. And we do expect to make good progress on those by the end of the year. I would expect that we've achieved one or more licensing deals by the end of the year. And so, I'm pretty confident with the resources that we've got available to us with some additional non-dilutive funding that we're working on at the moment that we'll be able to achieve those milestones that we've got planned for this year.
特里格·休斯:好問題。布魯斯.因此,正如我們剛才提到的,年底我們在銀行存有 2,070 萬美元的現金。去年我們在經營活動中使用的淨現金為 1,810 萬美元。所以這被部分抵消了——或者說成本被我們去年收到的 1300 萬美元的許可費部分抵消了。我們可以預期的是,今年我們的成本將略低於去年。這在一定程度上是我們去年年底採取的成本節約行動的結果,全年節省了略高於 200 萬美元的成本。正如卡梅倫所提到的,我們今年的重點是在人類領域達成下一個許可協議。因此,我們也開始努力在美國尋求非稀釋性資金。正如卡梅倫所提到的,我們再次考慮讓每一條腿都支持自己。我們關注的是引入這些許可協議,以便我們能夠實現預付款和里程碑付款。我們確實希望在今年年底前在這些方面取得良好進展。我預計到今年年底我們將達成一項或多項授權協議。因此,我對我們可用的資源以及我們目前正在努力的一些額外的非稀釋性資金非常有信心,我們將能夠實現我們今年已經取得的這些里程碑計劃。
Operator: Our next question is from Steven Ralston with Zacks. Please proceed.
接線生:我們的下一個問題來自 Zacks 的 Steven Ralston。請繼續。
Steven Ralston: You certainly have a lot of irons in the fire right now, more than I've seen in the past. And despite the progress you made in your R&D efforts in cancer and sepsis, I'm trying to get a better handle on your two developing revenue streams. When I look at the -- you have product categories, product and service listed and the revenue streams are in the vet and Discover areas. Could you delineate those a little better, so I can better model the company?
史蒂文‧羅爾斯頓:你現在確實有很多事情要做,比我過去見過的還要多。儘管你們在癌症和敗血症方面的研發工作取得了進展,但我仍在努力更好地處理你們兩個正在發展的收入來源。當我查看時,您列出了產品類別、產品和服務,收入來源位於獸醫和發現領域。您能否更好地描述這些內容,以便我可以更好地為公司建模?
Cameron Reynolds: Terig?
卡梅倫雷諾茲:特里格?
Terig Hughes: Yes, sure. So -- what -- in terms of our vet revenue, we achieved about $475,000 of net revenue last year. That was up 194%. And that does not yet ramp but we expect it to start ramping this year as we bring online the two new distributors. So, we've got Antech and Fuji Vet, who are both about to launch both aggressively pricing the test in the market at under $40, both having aggressive plans for marketing and launching of the test. So, looking ahead, I think we'll see a decent ramp starting in Q2 and going into the second half of the year. So, on Nu.Q Discover, we did about $300,000 of earned revenue last year. We've also got a very good pipeline building of over $1 million of opportunities. And that's a bit more difficult to forecast quarter-to-quarter because it's very lumpy in nature because of a number of projects of different sizes and then the timing is somewhat [indiscernible] difficult to estimate. But I do expect to see strong growth over the next year and for the year as a whole. So, I think we can look forward to further strong growth in the Nu.Q discover projects. Did that answer your question?
特里格·休斯:是的,當然。那麼,就我們的獸醫收入而言,去年我們實現了約 475,000 美元的淨收入。增長了 194%。這還沒有增加,但我們預計隨著我們將兩個新經銷商上線,它將在今年開始增加。因此,我們有 Antech 和 Fuji Vet,他們都即將在市場上積極推出將測試價格定在 40 美元以下的產品,並且都制定了積極的營銷和推出測試計劃。因此,展望未來,我認為我們將在第二季度開始並進入今年下半年看到一個不錯的成長。因此,去年我們在 Nu.Q Discover 上獲得了約 30 萬美元的收入。我們還擁有一個非常好的管道建設,價值超過 100 萬美元的機會。逐季預測有點困難,因為它本質上非常不穩定,因為有許多不同規模的項目,而且時間安排有些[難以辨別]難以估計。但我確實預計明年和全年都會強勁成長。因此,我認為我們可以期待 Nu.Q 發現專案進一步強勁成長。這回答了你的問題嗎?
Steven Ralston: I think so. In other words, some of the Discover revenue is -- well, discover revenue is classified both under product and service categories.
史蒂文·羅爾斯頓:我想是的。換句話說,一些發現收入 - 嗯,發現收入分為產品和服務類別。
Terig Hughes: That's right. It is. So, we -- it's probably slightly more weighted towards the service than the product.
特里格·休斯:沒錯。這是。所以,我們可能更注重服務而不是產品。
Steven Ralston: Is it too early in the process to determine the relative profitability between Discover and Vet?
Steven Ralston:現在確定 Discover 和 Vet 之間的相對獲利能力是否為時過早?
Terig Hughes: So, both are highly profitable in terms of gross margin. Vet, I would say, is probably higher or more highly profitable once we get it to scale and Discover although highly profitable, there's a service element there and that makes it slightly less profitable, but still we have very, very good gross margins on both products.
Terig Hughes:所以,就毛利率而言,兩者都是高利潤的。我想說的是,一旦我們擴大規模,獸醫的利潤可能會更高或更高,並且發現雖然利潤很高,但其中有一個服務元素,這使得它的利潤略低,但我們在這兩個方面仍然有非常非常好的毛利率產品。
Steven Ralston: Also, is there a corporate model of when to capture your deferred revenue? I know it's a long tail and a very large market, and it might be too early to determine that, but you are generating some sales in that and therefore, some miniscule percentage of the deferred revenue should be coming over through the bottom line, well, being put into the top line to come
Steven Ralston:另外,是否有一個企業模型來決定何時取得遞延收入?我知道這是一個長尾和一個非常大的市場,現在確定這一點可能還為時過早,但你正在其中產生一些銷售額,因此,遞延收入的一小部分應該通過底線來實現,好吧,被放入頂線來
Terig Hughes: Yes, that's a good point. And I'm glad you brought that up because as you know, we've received about $23 million so far in payments related to the license agreement with Heska now Antech. And that's currently classified as deferred income on the balance sheet. And I do expect that to start earning out this year because it's linked to when the point of care or in-house diagnostic test launches with Heska, which is, as we said, is imminent. And so, I do expect to start to see some of that burning this year, but is a long tail over the lifetime of the agreement, which is 20 years.
特里格·休斯:是的,這是一個很好的觀點。我很高興您提出這個問題,因為如您所知,到目前為止,我們已收到與 Heska(現在是 Antech)的許可協議相關的約 2300 萬美元付款。目前,這在資產負債表上被歸類為遞延收入。我確實預計今年會開始獲利,因為這與 Heska 推出護理點或內部診斷測試的時間有關,正如我們所說,這即將到來。因此,我確實預計今年會開始看到其中一些燃燒,但在協議的有效期(20 年)中,這是一個長尾。
Steven Ralston: Thank you. Just two comments. I'd like to thank you for those informative webinars on cancer and sepsis. I've listened to them several times. Every time I listen to them, I get more out of it. and also, that the $2 million cost cutting was not unnoticed, it came all below my expectations with the lower cost.
史蒂文·羅爾斯頓:謝謝。只有兩則評論。我要感謝您舉辦有關癌症和敗血症的資訊豐富的網路研討會。我聽過他們好幾次了。每次我聽他們講話,我都能從中得到更多。而且,200 萬美元的成本削減也引起了人們的注意,成本降低後,一切都低於我的預期。
Operator: We have reached the end of our question-and-answer session. I would like to turn the conference back over to Cameron for closing remarks.
接線生:我們的問答環節已經結束了。我想將會議轉回卡梅倫致閉幕詞。
Cameron Reynolds: Thank you, everyone, for attending our call. We really appreciate it. And we look forward to updating you with all the developments that we've outlined over the next few months and on the first quarter earnings call, which is, of course, due in mid-May. So, thank you very much, and have a great day. Thank you.
卡梅倫‧雷諾茲:謝謝大家參加我們的電話會議。我們真的很感激。我們期待向您通報我們在未來幾個月和第一季財報電話會議上概述的所有進展情況,當然,第一季財報電話會議將於 5 月中旬舉行。所以,非常感謝您,祝您有美好的一天。謝謝。
Operator: Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.
接線生:謝謝。今天的會議到此結束。此時您可以斷開線路,感謝您的參與。
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
本文是在人工智慧的支援下產生的,並經過編輯審查。欲了解更多信息,請參閱我們的條款和條件。
免責聲明:info@kdj.com
所提供的資訊並非交易建議。 kDJ.com對任何基於本文提供的資訊進行的投資不承擔任何責任。加密貨幣波動性較大,建議您充分研究後謹慎投資!
如果您認為本網站使用的內容侵犯了您的版權,請立即聯絡我們(info@kdj.com),我們將及時刪除。
-
- 布雷特 (BRETT) 價格預測 - 2024 年 11 月 5 日
- 2024-11-05 14:25:02
- 根據我們的 Brett 價格預測,未來 5 天內 BRETT 價格預計將上漲 30.05%
-
- 罕見的 2 英鎊硬幣可以讓你在聖誕節前夕賺到一筆方便的閒錢 - 這一切都歸功於印刷錯誤
- 2024-11-05 14:25:02
- 2019 年發行的 2 英鎊硬幣的設計缺陷可能使其價值達到原值的 50 倍。
-
- 幣安在資產上市成本政策相關指控後重新成為人們關注的焦點
- 2024-11-05 14:25:02
- 雅加達 - 幣安是世界上最大的加密貨幣交易所之一,在受到與其資產上市成本政策相關的指控後,再次成為人們關注的焦點。