KORU Medical Systems Inc (KRMD) 2024 Q2 法說會逐字稿

Greetings and welcome to the KORU Medical Systems Second Quarter 2024 earnings call. At this time, all participants are in a listen only mode, a brief question and answer session will follow the formal presentation. Anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Louisa Smith. Thank you. You may begin.

您好，歡迎參加 KORU 醫療系統 2024 年第二季財報電話會議。此時，所有參與者都處於僅聽模式，正式演示之後將進行簡短的問答環節。會議期間任何人如果需要接線員協助，請按電話鍵盤上的星號，然後按零。提醒一下，本次會議正在錄製中。現在我很高興向大家介紹你們的主持人，路易莎史密斯。謝謝。你可以開始了。

Good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, core medical systems released financial results for the second quarter ended June 30th, 2024. The copy of the press release is available on the company's website. I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter. Additionally, we will use slides to support commentary in today's call, which are also available on the Investor Relations section of our website. During this call, we will make certain forward-looking statements regarding our business plans and other matters that these comments are based on our predictions and expectations. As of today, actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements during the call, management will also discuss certain non-GAAP financial measures. We will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release in comparing investor presentation and SEC filings for the benefit of those risks. Listening to the replay, this call was held and recorded on Wednesday, August seventh, 2024, at approximately 4.30 p.m. Eastern Time. Since then, the Company may have made additional comments related to the topics discussed. Linda, please go ahead.

大家下午好。今天參加電話會議的有 KORU Medical Systems 總裁兼執行長 Linda Tharby 和財務長 Tom Adams。今天早些時候，核心醫療系統發布了截至 2024 年 6 月 30 日的第二季財務表現。新聞稿的副本可在公司網站上取得。我鼓勵聽眾將我們的新聞稿放在你們面前，其中包括我們的財務表現以及對本季的評論。此外，我們將在今天的電話會議中使用幻燈片來支持評論，這些評論也可以在我們網站的投資者關係部分找到。在這次電話會議中，我們將就我們的業務計劃和其他事項發表某些前瞻性聲明，這些評論是基於我們的預測和期望。截至今天，由於許多風險和不確定性，包括相關新聞稿和我們最近向 SEC 提交的文件中提到的風險和不確定性，實際事件或結果可能會存在重大差異。我們不承擔在電話會議期間更新任何前瞻性陳述的義務，管理階層也將討論某些非公認會計準則財務措施。我們將在新聞稿中找到更多披露信息，包括這些非公認會計準則衡量標準與可比公認會計準則衡量標準的對賬，以比較投資者的陳述和美國證券交易委員會的文件，以規避這些風險。聽重播，這次電話會議於 2024 年 8 月 7 日星期三下午 4 點 30 分左右舉行並錄製。東部時間。此後，該公司可能就所討論的主題發表了額外的評論。琳達，請繼續。

Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. I will begin with our second quarter results and key business updates followed by Tom, who will review our financials and 2024 guidance before turning it back to me for closing comments following the prepared remarks, we will open the line for questions. In Q2, we continued our strong momentum and delivered another quarter of record revenues as we executed on our 2024 milestones and progress towards Vision 2026. Second quarter revenues were $8.4 million, a 22% growth over the same period in 2023. Core business revenues grew 20% driven by SCIG. market growth, share gains and geographic expansion. Our novel therapies business, which serves as a business development pipeline for new drugs on our Freedom pump platform also had a strong quarter as we progressed several of our collaborations closer to commercialization. This included successful feasibility results for an oncology biologic collaboration that we announced in Q1 and the entry into a Phase three trial for an expanded nephrology indication for an existing drug. Additionally, in June, we received the long-awaited regulatory clearance for our FREEDOM EDGE infusion system for use in Japan, an important milestone in our international core business that will further expand our global reach and growth. From an operations standpoint, we continued our focused efforts on cash flow breakeven with progress on multiple fronts. Higher revenues combined with gross margins above 60% and further improvement in our operating efficiencies and working capital led to an overall reduction in Matla Mine loss and brought us closer to our projected fourth quarter cash flow breakeven. Progress against all of these milestones gives us confidence to raise our 2024 full year revenue and gross margin guidance ranges and reaffirm our cash guidance. Before moving on to additional highlights, I'd also like to provide an update on the recent announcement about how we are refining our corporate organization structure. This past month, we announced the promotion of Chris passed and our SVP of Operations to the role of Chief Operating Officer. This new role brings together all of our key functions under one leader, providing the focus and alignment needed to drive delivery on our pivotal product and program growth and operational targets. And in three years with Cory. Chris has proven himself as a transformative business leader has consistently delivered results, and I'm confident he will continue to have tremendous impact on our success. Moving on to our key business results. I'll review highlights from each of our strategic growth pillars, protecting and growing our core domestic as the IG business expanding internationally and broadening our relevance with the addition of new drugs on our label, our novel therapies business. Within domestic core, we saw strong double digit revenue growth of 14% over the prior year and continue to outpace a healthy SCGSCIG. market that's growing mid to high single digits. We accomplished this through increased penetration in new and existing accounts with both pumps and consumables. We also saw double digit end-user sales growth, an indication of strong customer demand for our products. The underlying IG market recorded a six quarter of sequential growth, indicating an increase in new patient starts. We continue to see our pharma partners drive prefilled syringe adoption, a more convenient option for patients and fastest-growing segments within SCIG. We expect to continue our momentum with the new product five 10 K submission in Q4 aimed at improving comfort and convenience for our patient base. Moving to international, we had a very strong quarter finishing at 46% year-over-year growth, excluding distributor stocking, which Tom will elaborate further on during his remarks, we saw growth in the plus 20% range. Strong performance was driven by underlying IG market growth, increased penetration in current markets and new indication expansion into new markets. As prior mentioned, we also received regulatory clearance, appropriate Emageon Japan that will provide further upside in 2025 and beyond as we see continued subcutaneous market development in our mind novel therapy business development efforts, we are focused on growing the number of drugs in our Freedom infusion platform. We currently have 16 pipeline collaborations to date, including three signed this year. This quarter, we successfully passed feasibility for our prior announced commercialized oncology biologics. This is exciting as we anticipate that we'll file a five 10 K for this product in 2025. In addition, we progressed to Phase three trials for a new nephrology indication for a currently marketed drug, and we have a rare disease biologic, which is in development phase and remains on track for a five 10 K submission by the end of the year. This will enable our first entry into infusion clinics, a prime new market for core growth. And finally, we also announced during the quarter an agreement with SCHOTT pharma, the world leader in large-volume prefilled syringes to optimize and grow the market for large-volume drug delivery. I wanted to take a few moments to dive deeper into the USSCIG. market. Our largest market where we hold a leadership position and discuss what we see as continued future growth drivers. The graph illustrates the overall patient growth, nine g., combining both IV and subcu as well as the growth in SCIG. a few notes to highlight. Overall, SCIG. growth is projected in the mid to high single digits and is expected to increase in penetration with SCIG. growth outpacing the overall IG. We have a recurring patient base of just over 30,000 patients in the U.S. Most of these patients have a chronic disease and will be on our pump for their life, creating a large recurring revenue base through the sale of consumables. In addition, there are multiple near-term catalysts that have the ability to expand our U.S. patient base. One of the primary opportunities we see as a market wide shift towards SCIG. as a preferred therapy. The IG pharmaceutical companies are making investments in their subcutaneous portfolio. A recent highlight from the quarter was the FDA approval of an expanded label for NSCIG. drug simplified to include treatment naive patients with primary immunodeficiency. The significance of this is that to date, the FDA had required the start of IV therapy prior to the start of subcutaneous therapy. This approval means the health care provider can put the patient directly on SCIG. In addition, the CIDP. market, which accounts for about 10% of our overall patient base continues to grow with new diagnosis and a new delivery option PFS, which makes it more convenient for this high-volume dexterity challenge patient to move to SCIT. therapy, Core's emphasis on our key accounts and partnerships, focus on leadership in clinical practice and in innovation and SCIG. devices while continuing to ensure we remain a preferred partner, customers and payers. Moving on to international, we are pleased with our 40% growth this quarter and wanted to provide some insight into what we see as a continued geographic expansion opportunity ahead of us. There's approximately $60 million of SCIG. TAM in markets outside of the US of the U.S. altogether, representing a larger TAM than the US market alone. We are currently marketed in 25 countries worldwide that as you see in the graphic, our overall penetration into these markets has been relatively low our strategy is continue to work with pharmaceutical companies and distribution partners on tailored device and patient programs to both increase our penetration in current markets and drive increased penetration into new SCIG. Our recent entry to Japan is one of these examples. We look forward to continuing our geographic expansion efforts and believe it represents an attractive opportunity for growth the next slide represents our novel therapies pipeline, 16 collaborations in total, each one, an opportunity to place a new drug on our label or expand existing drugs. Our innovations into new indications, which in total it's a $2.1 million or $2.1 million global patient population opportunity. The yellow highlights indicate the prior mentioned progress within the quarter, including the first clearance of freight. I mentioned Japan, progression of our oncology Asic collaboration and our expanded nephrology indication. Moving into a Phase three trial in total, we now have six opportunities for new drugs to be cleared for use with the core platform by 2026, creating a path to it $10 to $20 million of annualized commercial revenue potential at the end of 2026. We are very pleased with our progress we made this quarter on multiple fronts, double digit growth in our core business, continued progress in our novel therapies pipeline and increased operating leverage through focused execution from our team. I will now turn the call over to Tom to review our financial results.

謝謝你，路易莎。大家下午好，感謝您今天加入我們。我將從我們的第二季度業績和關鍵業務更新開始，然後是湯姆，他將審查我們的財務狀況和2024 年指導，然後將其返回給我以在準備好的評論之後發表結束評論，我們將打開提問熱線。第二季度，我們繼續保持強勁勢頭，在執行 2024 年里程碑並朝著 2026 年願景邁進的過程中，營收又創下季度紀錄。第二季營收為 840 萬美元，較 2023 年同期成長 22%。在SCIG的推動下，核心業務收入成長了20%。市場成長、份額成長和地理擴張。我們的新療法業務是我們 Freedom 泵平台上新藥的業務開發管道，隨著我們的多項合作接近商業化，該業務也取得了強勁的季度業績。這包括我們在第一季宣布的腫瘤生物學合作的成功可行性結果，以及進入擴大現有藥物腎病變適應症的第三階段試驗。此外，六月，我們的 FREEDOM EDGE 輸液系統獲得了期待已久的監管許可，可在日本使用，這是我們國際核心業務的一個重要里程碑，將進一步擴大我們的全球影響力和成長。從營運角度來看，我們持續專注於現金流損益平衡，並在多個方面取得進展。更高的收入加上超過 60% 的毛利率以及我們營運效率和營運資金的進一步改善，導致 Matla 礦場虧損全面減少，並使我們更接近預計的第四季度現金流盈虧平衡。所有這些里程碑的進展使我們有信心提高 2024 年全年收入和毛利率指引範圍，並重申我們的現金指引。在繼續介紹其他亮點之前，我還想提供有關我們如何完善公司組織結構的最新公告的最新資訊。上個月，我們宣布將營運高級副總裁克里斯晉升為營運長。這個新角色將我們所有的關鍵職能集中在一位領導者的領導下，提供推動關鍵產品和計畫成長以及營運目標交付所需的重點和協調。和科里一起度過了三年。克里斯已經證明自己是一位變革性的商業領袖，始終如一地取得了成果，我相信他將繼續對我們的成功產生巨大影響。接下來是我們的主要業務成果。我將回顧我們每個策略成長支柱的亮點，隨著IG 業務向國際擴張，保護和發展我們的核心國內業務，並透過在我們的標籤上添加新藥、我們的新療法業務來擴大我們的相關性。在國內核心業務方面，我們的收入比上一年實現了 14% 的強勁兩位數成長，並繼續超越健康的 SCGSCIG。市場以中高個位數成長。我們透過增加泵浦和消耗品在新客戶和現有客戶中的滲透率來實現這一目標。我們也看到最終用戶銷售額實現兩位數成長，這顯示客戶對我們產品的需求強勁。基礎 IG 市場錄得連續六個季度的成長，顯示新患者開始增加。我們繼續看到我們的製藥合作夥伴推動預充式註射器的採用，這對患者和 SCIG 內成長最快的細分市場來說是一個更方便的選擇。我們希望在第四季度提交新產品 5 10 K 來繼續我們的勢頭，旨在提高患者群體的舒適度和便利性。轉向國際，我們有一個非常強勁的季度，同比增長 46%，不包括經銷商庫存，湯姆將在他的演講中進一步闡述這一點，我們看到了 20% 以上的增長。強勁的業績得益於 IG 市場的潛在成長、當前市場滲透率的提高以及新市場的新適應症擴張。如前所述，我們也獲得了監管許可，適當的Emageon Japan 將在2025 年及以後提供進一步的上行空間，因為我們看到皮下市場的持續發展在我們心目中的新型治療業務開發努力中，我們專注於增加我們自由中的藥物數量輸液平台。迄今為止，我們已有 16 項管道合作，其中今年簽署了 3 項。本季度，我們成功通過了先前宣布的商業化腫瘤生物製劑的可行性。這是令人興奮的，因為我們預計我們將在 2025 年為此產品提交 5 個 10 K。此外，我們對目前上市的藥物的新腎病適應症進行了第三階段試驗，並且我們有一種罕見疾病生物製劑，該生物製劑正處於開發階段，並預計在今年年底前提交5 個10 K 的申請。這將使我們能夠首次進入輸液診所，這是核心成長的主要新市場。最後，我們也在本季宣布與大容量預充注射器的全球領導者肖特製藥公司達成協議，以優化和發展大容量藥物輸送市場。我想花一些時間更深入地了解 USSCIG。市場。我們在最大的市場中佔據領導地位，並討論我們認為未來持續成長的驅動力。此圖顯示了患者的整體生長情況，即 9 克，結合 IV 和 subcu 以及 SCIG 中的生長情況。需要強調的一些注意事項。總體而言，SCIG。預計成長率為中高個位數，且 SCIG 的滲透率預計將提高。成長速度超過整體 IG。我們在美國擁有超過 30,000 名患者的經常性患者群。此外，還有多種近期催化劑能夠擴大我們的美國患者基礎。我們認為主要機會之一是市場向 SCIG 的廣泛轉變。作為首選療法。IG 製藥公司正在對其皮下產品組合進行投資。本季度最近的一個亮點是 FDA 批准了 NSIG 的擴展標籤。藥物簡化為包括未經治療的原發性免疫缺陷患者。意義在於，迄今為止，FDA 要求在開始皮下治療之前開始靜脈注射治療。這項批准意味著醫療保健提供者可以直接將患者置於 SCIG 上。此外，CIDP。占我們整體患者群約 10% 的市場隨著新的診斷和新的交付選項 PFS 持續增長，這使得這種大容量靈活性挑戰患者更方便地轉向 SCIT。在治療方面，Core 強調我們的關鍵客戶和合作夥伴，專注於臨床實踐、創新和 SCIG 的領導。設備，同時繼續確保我們仍然是首選合作夥伴、客戶和付款人。轉向國際市場，我們對本季 40% 的成長感到滿意，並希望就我們所看到的持續地理擴張機會提供一些見解。SCIG 大約有 6000 萬美元。美國以外市場的 TAM 總計比美國市場的 TAM 還要大。我們目前在全球25 個國家/地區進行行銷，如圖所示，我們對這些市場的整體滲透率相對較低，我們的策略是繼續與製藥公司和分銷合作夥伴合作開發客製化設備和患者計劃，以提高我們在並推動對新 SCIG 的滲透。我們最近進入日本就是其中之一。我們期待繼續我們的地域擴張努力，並相信這代表著一個有吸引力的增長機會，下一張幻燈片代表了我們的新療法管道，總共16 項合作，每一項都是一個將新藥放在我們標籤上或擴展現有藥物的機會。我們針對新適應症的創新，總共為全球患者群體帶來了 210 萬美元或 210 萬美元的機會。黃色突出顯示了前面提到的季度內的進展，包括第一次貨運清關。我提到了日本、我們腫瘤學 Asic 合作的進展以及我們擴大的腎臟病適應症。總共進入第三階段試驗，我們現在有六次機會在 2026 年之前批准新藥與核心平台一起使用，從而為 2026 年底實現 10 至 2000 萬美元的年化商業收入潛力創造了道路。我們對本季在多個方面取得的進展感到非常滿意，我們的核心業務實現了兩位數的成長，我們的新療法管道持續取得進展，並透過我們團隊的集中執行提高了營運槓桿。我現在將把電話轉給湯姆，以審查我們的財務表現。

Thank you, Linda, and thanks to everyone joining us this afternoon. We are very pleased with our second quarter results as we saw another quarter of double-digit top line growth and our record revenues. Second quarter net revenues for the second quarter were $8.4 million, a 22% increase compared to the prior year period. Our domestic core revenue grew 14% with net revenues of $6.2 million, driven by higher consumable volumes as a result of new patient starts and share gain. Our international core business grew 46% year over year with revenues of $1.6 million, driven by an improved IG supply versus the prior year and increased penetration in CIDP. and SID. approved indications and continued geographic expansion, 46% growth rate for international core included about 300,000 of accelerated shipments as a result of residual effects from the BSI. appeal that we discussed last quarter. Normalized growth, excluding these orders was approximately 20%. Our not our novel therapies revenue, which we consider to be co route pre-commercial launch collaboration revenue for services and clinical trial products was 600,000 at 50% improvement compared to prior year, driven by the completion of three clinical trial orders for our pipeline collaboration, we continue to diversify our customer base and pipeline collaborations as we work on additional agreements that will bolster our future quarters commercial business, our first quarter gross margin improved to 65%, an 890 basis point increase compared to the prior year. As indicated on the bar graph on the right, the strong improvement was largely due to manufacturing efficiencies driven by the consolidation of our US manufacturing sites. This marks the fourth consecutive quarter that we have achieved margins greater than 60%. And we continue to leverage operational excellence to identify and realize manufacturing improvements and efficiencies across our operations. Additionally, we have seen improved gross margins in novel therapies from our sales mix with higher levels of clinical trial orders and in the US core business, we recognize year-over-year increases in average selling prices. I'd like to note that in the quarter, gross margin was positively impacted by $140,000 inventory valuation adjustments that resulted in about 160 basis points of margin improvement that we do not expect to recur in the second half of the year. Moving on to cash as of June 30th, we had an ending cash balance of $10.5 million, representing cash usage of $300,000 in the quarter. The overall level of cash usage in the quarter was partially driven by net losses of 200,000, which excludes non-cash items of stock compensation, depreciation and amortization. This was an improvement of $1.9 million over the prior year. In addition, we used $300,000 of cash to invest in capital equipment for our new production lines, and we paid for our financing line for our D&O insurance Partially offsetting these uses of cash flow improvements of working capital of $300,000 with respect to our inventory levels. And we also brought down by a strong revenue quarter, which was partially offset by accounts receivable driven by the same strength in the quarter. As we look ahead, our cash and cash flow targets remain on track, and we are substantially reducing our cash burden since last year. In the first half of the year, we had cash usage of $1 million. We expect the second half cash usage to be higher than our first half with peak spending coming in Q3, driven by the majority of our capital investment outlay for our new production line and the related R&D project spending on innovation to bring new products to market. We remain confident that we will end the year with a greater than $8 million cash balance as well as being cash flow breakeven in the fourth quarter. I would also like to remind everyone that the ending cash balance of at least $8 million is exclusive of our undrawn $10 million credit facility. That is being reserved for Strategic Growth Capital. Moving on to 2024 guidance. When we originally set our guidance, we noted some key drug key growth drivers that would enable our success. Those being mid to high single digit SCIG. market growth, three new novel therapy collaborations, an underlying prefilled syringe penetration of 20% to 25%. Now that we have two quarters behind us, we have delivered against our novel therapies milestones and are seeing a very healthy SCIG. market with increasing prefilled syringe demands. We are raising our revenue and gross margin guidance. We expect the following for the remainder of the year revenues of $32 million to $32.5 million, up from the prior range of $31.2 to $30.2 million and representing 12% to 14% growth over prior year. And please note, we mentioned in our commentary on international sales that we saw growth levels in the second quarter that we do not anticipate to be recurring. Our updated guidance accounts for international sales normalizing for the rest of the year. As for gross margins, we now expect a full year gross margin between 61% and 62%. While we anticipate more pressure on margin from expanding into lower SP. lesions, we continue to face inflationary pressure with our supply chain. We have managed to hold and improve our margin internally with additional manufacturing efficiencies and improved sales mix margin and novel therapies. Lastly, I mentioned before, we expect to finish with an ending cash balance of more than $8 million, which includes approximately $23.5 to $24 million in operating expense this ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of 24. Our credit facility reserve remains available to us for strategic growth opportunities. What is not included in our estimates for 2024 ending cash balance. With that, I will now turn the call back to Linda for closing remarks.

謝謝你，琳達，也感謝今天下午加入我們的所有人。我們對第二季的業績感到非常滿意，因為我們看到另一個季度實現了兩位數的營收成長和創紀錄的收入。第二季淨收入為 840 萬美元，比去年同期成長 22%。我們的國內核心收入成長了 14%，淨收入達到 620 萬美元，這得益於新患者的開始使用和份額成長帶來的耗材量增加。我們的國際核心業務年增 46%，營收達到 160 萬美元，這得益於 IG 供應量較上年有所改善以及 CIDP 滲透率的提高。和SID。經批准的適應症和持續的地理擴張，國際核心的成長率為 46%，其中包括由於 BSI 的殘餘影響而加速出貨的約 30 萬件。我們上季討論過的呼籲。排除這些訂單，正常成長約為 20%。我們的非新療法收入（我們認為是服務和臨床試驗產品的商業上市前合作收入）為 600,000 美元，比上年增長 50%，這是由我們管道合作完成三項臨床試驗訂單推動的，我們繼續使我們的客戶群和通路合作多樣化，因為我們正在努力達成更多協議，以支持我們未來幾季的商業業務，我們第一季的毛利率提高到65%，與前一年相比增加了890 個基點。正如右側長條圖所示，強勁的改善主要歸功於我們美國製造基地的整合所帶來的製造效率。這標誌著我們連續第四個季度實現利潤率超過 60%。我們繼續利用卓越營運來確定並實現整個營運的製造改進和效率。此外，隨著臨床試驗訂單水準的提高，我們的銷售組合中新療法的毛利率有所提高，並且在美國核心業務中，我們認識到平均銷售價格同比增長。我想指出的是，本季毛利率受到 14 萬美元庫存估值調整的正面影響，導致利潤率提高約 160 個基點，我們預計下半年不會出現這種情況。轉向現金方面，截至 6 月 30 日，我們的期末現金餘額為 1,050 萬美元，相當於本季的現金使用量為 30 萬美元。本季現金使用的整體水準部分是由 200,000 的淨虧損推動的，其中不包括股票補償、折舊和攤提等非現金項目。這比前一年增加了 190 萬美元。此外，我們使用 300,000 美元現金投資新生產線的資本設備，並支付 D&O 保險的融資額度，部分抵消了與我們的庫存水平有關的 300,000 美元營運資金的現金流改善的使用。我們也受到強勁的營收季度的影響，這被本季同樣強勁的應收帳款部分抵銷。展望未來，我們的現金和現金流目標仍處於正軌，並且自去年以來我們正在大幅減輕現金負擔。上半年，我們的現金使用量為100萬美元。我們預計下半年現金使用量將高於上半年，支出高峰將在第三季到來，這主要是由於我們新生產線的大部分資本投資支出以及將新產品推向市場的創新相關研發項目支出的推動。我們仍有信心在年底時擁有超過 800 萬美元的現金餘額，並在第四季實現現金流收支平衡。我還想提醒大家，期末現金餘額至少為 800 萬美元，不包括我們未提取的 1,000 萬美元信貸額度。這是為策略成長資本保留的。轉向 2024 年指導。當我們最初制定指導方針時，我們注意到了一些能夠使我們成功的關鍵藥物關鍵成長驅動因素。這些是中高個位數 SCIG。市場成長、三種新的新型療法合作、預充注射器的潛在滲透率達到 20% 至 25%。現在已經過去了兩個季度，我們已經實現了新療法的里程碑，並且看到了非常健康的 SCIG。市場對預充式註射器的需求不斷增加。我們正在提高收入和毛利率指引。我們預計今年剩餘時間的收入將達到 3,200 萬至 3,250 萬美元，高於先前的 31.2 至 3,020 萬美元，比上年增長 12% 至 14%。請注意，我們在國際銷售評論中提到，我們看到第二季度的成長水平，但預計不會再次出現。我們更新的指導說明了今年剩餘時間國際銷售的正常化。至於毛利率，我們目前預計全年毛利率在 61% 至 62% 之間。雖然我們預期擴張到較低的 SP 會對利潤率帶來更大的壓力。病變，我們的供應鏈持續面臨通膨壓力。我們透過提高生產效率、改善銷售組合利潤和創新療法，成功地維持並提高了內部利潤。最後，我之前提到過，我們預計期末現金餘額將超過 800 萬美元，其中包括約 2350 至 2400 萬美元的營運費用，該期末餘額不包括股票報酬，並包括我們將達到現金流盈虧平衡的預期24號第四季。我們的信貸額度儲備仍可供我們用於策略成長機會。我們對 2024 年期末現金餘額的估計中未包含哪些內容。現在，我將把電話轉回給琳達，讓她發表結束語。

Thanks, Tom. This quarter we continued to execute on our business strategy and saw strong results as we did so. And we'll continue this focus in the back half. We grew double digits, outperforming our growing USSCIG. market and expanded our international reach. Our novel therapies business development efforts are becoming increasingly relevant as multiple pipeline drugs approach approval for use on our platform, a critical inflection point for the business. We expect that we will see continued differentiation of pull-through and our Freedom infusion platform with a submission for a new product and a new drug by the end of 2024. We also made meaningful progress in our operating leverage towards our goal of cash flow breakeven by end of year. This strength across each of our strategic business areas generated record revenues and gives us the confidence to reiterate each of our 2024 milestones highlighted these milestones are indicators of our progress towards our longer-term vision 2026 pools. Our first half momentum is encouraging as we continue on our journey to transform the company to a global leader in large volume subcutaneous drug delivery. In closing, I'd like to thank everyone on the core medical team for the hard work they do every day to create a superior patient experience and drive value for each of our stakeholders. Operator, I will now turn the call over for Q&A.

謝謝，湯姆。本季度，我們繼續執行我們的業務策略，並取得了強勁的業績。我們將在後半段繼續關注這一點。我們實現了兩位數的成長，超過了不斷成長的 USSCIG。市場並擴大了我們的國際影響力。隨著多種管道藥物獲得批准在我們的平台上使用，我們的新療法業務開發工作變得越來越重要，這是業務的關鍵轉折點。我們預計，到 2024 年底，我們將看到 Pull-Through 和 Freedom 輸液平台的持續差異化，並提交新產品和新藥物。我們在營運槓桿方面也取得了有意義的進展，以實現到年底現金流收支平衡的目標。我們每個策略業務領域的這種優勢都創造了創紀錄的收入，並使我們有信心重申 2024 年的每一個里程碑，並強調這些里程碑是我們在實現 2026 年長期願景方面取得進展的指標。我們上半年的勢頭令人鼓舞，我們繼續致力於將公司轉型為大容量皮下給藥領域的全球領導者。最後，我要感謝核心醫療團隊中的每個人每天所做的辛勤工作，為我們的每個利害關係人創造卓越的患者體驗並推動價值。接線員，我現在將電話轉過去進行問答。

Thank you. We will now be conducting the question and answer session. If you'd like to ask a question, please press star and then one on your telephone keypad. Confirmation tone will indicate your line is in the question queue. You may press star and then two, if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. First question we have is from Caitlin Cronin of Canaccord Genuity. Please go ahead.

謝謝。我們現在將進行問答環節。如果您想提問，請按下電話鍵盤上的星號，然後再按一個。確認音將表示您的線路已在問題佇列中。如果您想從佇列中刪除您的問題，可以按星號，然後按兩顆。對於使用揚聲器裝置的與會者，可能需要在按星號鍵之前拿起聽筒。我們收到的第一個問題來自 Canaccord Genuity 的 Caitlin Cronin。請繼續。

Hi. Congrats on a great quarter and thanks for taking the questions. Just to start, you mentioned some prefilled syringe penetration being a driver of revenue guidance you've given you raised the revenue guidance Square. Is prefilled syringe penetration at this point? And jumping off of that, how is the progress on the 50 mill and prefilled syringe launch earlier this year.

你好。恭喜您度過了一個出色的季度，並感謝您提出問題。首先，您提到一些預充填注射器滲透率是您提供的收入指引的驅動因素，您提高了 Square 的收入指導。此時預充式註射器是否會穿透？首先，今年稍早推出的 50 磨機和預充式註射器的進展如何。

So, thanks for the congrats. We're excited by the progress this quarter, specifically related to prefilled syringes. As you are aware of the leader in the US market, which is CSL has launched now their entire prefilled syringe platform, which is compatible with our core devices. The market uptake is getting stronger through Q2 as their intention is to move their entire platform over to prefilled syringes by the end of the year. So we anticipate again for us, this is a one-on-one driver from vials to prefilled, where we're seeing that conversion. We think that the longer-term potential around prefilled syringes is the opportunity to bring more patients into the category as it's an easier format for the patient to use versus vials. So excited overall by our continued progress in the US market and prefilled syringes, a format change for us.

所以，謝謝你的恭喜。我們對本季的進展感到興奮，特別是與預充式註射器相關的進展。如您所知，美國市場的領導者 CSL 現已推出其整個預灌封注射器平台，該平台與我們的核心設備相容。第二季市場的吸收力越來越強，因為他們的目的是在年底前將整個平台轉移到預充式註射器。因此，我們再次預計，這是從小瓶到預先填充的一對一驅動程序，我們正在看到這種轉換。我們認為，預充式註射器的長期潛力是有機會讓更多患者進入該類別，因為與小瓶相比，它對患者來說更容易使用。總體而言，我們對美國市場和預充式註射器的持續進步感到非常興奮，這對我們來說是一種格式的改變。

Got it. Okay. And congrats on the Japan clearance. Do you plan to pursue TV2 clearance in other geographies as well?

知道了。好的。恭喜你在日本通過了。您是否也計劃在其他地區取得 TV2 許可？

I'm sorry, I missed the back end of that question.

抱歉，我錯過了這個問題的後端。

How do you plan to pursue TV2 clearance in other geographies other than Japan? Because I believe that that's the first clearance you had for that drug.

您打算如何在日本以外的其他地區獲得 TV2 許可？因為我相信這是您對該藥物的第一次許可。

TV2 specifically, or is it just more expanded geographies? Okay.

具體來說是 TV2，還是只是擴大了地理範圍？好的。

I don't know about that.

我對此一無所知。

Sorry, Colin. Go ahead.

對不起，科林。前進。

No, I mean, I was asking just about TV2 specifically since I don't believe you are cleared in other regions for that drug. But I mean, do you want to talk about the broader geographic expansion as well that we have.

不，我的意思是，我只是專門詢問 TV2 的情況，因為我不相信您在其他地區可以使用該藥物。但我的意思是，你想談談我們更廣泛的地理擴張嗎？

We are cleared for Cube true usage today, which is of Kita drug. We are cleared for that drug us specifically in the US market and broadly internationally and for that drug. So the significance overall for the Japan is just the entry into the Japan market. Yes, we did receive a clearance with Cuba true. We also received clearance, though, with CSL's presenter, a drug in that market, which compose about 95% of the overall Japanese market. So the significance for us, obviously, is Japan is a top 10 overall IG market, and we would anticipate that we will look for more significant approvals, specifically in Latin America and Asia APAC and for Cubic true in the future.

今天我們已經了解了 Cube 的真正用途，即 Kita 藥物。我們已獲得該藥物的許可，特別是在美國市場以及國際市場。所以對日本整體來說意義就是進入日本市場。是的，我們確實收到了古巴的許可。不過，我們也獲得了 CSL 的 Presenter 的許可，這是該市場的一種藥物，該市場約佔整個日本市場的 95%。因此，對我們來說，顯然，重要的是日本是整體 IG 市場前 10 名，我們預計我們將尋求更重要的批准，特別是在拉丁美洲和亞太地區以及 Cubic true 的未來。

Great. Thanks for taking the questions.

偉大的。感謝您提出問題。

Next question, we have is from Frank Takkinen of Lake Street Capital. Please go ahead.

下一個問題來自 Lake Street Capital 的 Frank Takkinen。請繼續。

Hey, this is Nelson Cox on for Frank. Thanks for taking the questions and great to see all the progress on I wanted to start with the expanded label for simplify, allowing patients to go straight to SCIG. I heard you mention it in the prepared remarks, but can you just walk us through that a bit more and how we should think about this impacting your business in the market overall?

嘿，我是弗蘭克的納爾遜·考克斯。感謝您提出問題，很高興看到所有進展，我想從擴展標籤開始簡化，讓患者直接前往 SCIG。我聽到您在準備好的發言中提到了這一點，但是您能否向我們詳細介紹一下這一點，以及我們應該如何考慮這對您在整個市場中的業務的影響？

For sure. Great question and thank you for the note of congratulations. So, all of the existing subcutaneous IG labels today calls for the health care provider to start the patient on an initial dose of IV therapy before progressing to SCIG. therapy those labels have been in existence for well over a decade now. And so, the significance of this is grapples with those Amplify label was the first drug manufacturer to go after a label that allowed them to go straight to SCIG. Well, this was becoming the standard of practice. It certainly was off-label usage. So, we anticipate that this will just make it a much and easier progression to go directly to SCIG. If I had a crystal ball, I'd love to give you an idea of what that might look like, but I think we're just going to have to see what happens in the coming quarters relative to health care practitioner use, and we will be shored up. Thank you on that.

一定。很好的問題，謝謝你的祝賀。因此，目前所有現有的皮下 IG 標籤均要求醫療保健提供者在進行 SCIG 治療之前先對患者進行初始劑量的 IV 治療。這些標籤已經存在十多年了。因此，此舉的意義在於解決那些 Amplify 標籤是第一家追求允許他們直接進入 SCIG 的標籤的藥品製造商。嗯，這正在成為實踐標準。這肯定是標籤外使用。因此，我們預計這將使直接進入 SCIG 變得更加容易。如果我有一個水晶球，我很樂意讓您了解它可能會是什麼樣子，但我認為我們只需要看看未來幾個季度與醫療保健從業人員的使用相關的情況會發生什麼，我們將得到支撐。謝謝你。

Perfect. And then I'm maybe just following up on Japan. Can you kind of talk about the strategy there and following the approval in July, how should we think about you guys entering that geography? And do you intend to go direct, or will you need to do any other work to ensure access?

完美的。然後我可能只是在跟進日本的情況。您能談談那裡的策略嗎？您打算直接進行，還是需要做任何其他工作來確保訪問？

Yes. So, on this will be we are still working to set up both our distributor and pharmaceutical company programs. So, we do have an existing distributor relationship, but all the details. We're still working through. We see Japan as a significant market. We believe it will be over time, one of our top 10th markets for IG, we believe that it will largely be consumables play Initially It is largely in the electronic pump market. So, we will be focusing on the use of our consumables in that market, and I don't see a big number in 2024, but see it adding about 5% to our overall growth number in 2025 for international.

是的。因此，在這方面，我們仍在努力建立我們的經銷商和製藥公司計劃。所以，我們確實有現有的經銷商關係，但所有細節都是如此。我們仍在努力解決。我們認為日本是一個重要的市場。我們相信隨著時間的推移，它將成為我們 IG 的十大市場之一，我們相信它將主要是消耗品市場，最初主要是在電子泵市場。因此，我們將重點關注我們的消耗品在該市場的使用，我認為 2024 年的數字不會很大，但預計 2025 年國際市場的整體成長量將增加約 5%。

Great. Thanks, guys and congrats again.

偉大的。謝謝大家，再次恭喜。

Thank you.

謝謝。

Ladies and gentlemen, just a reminder, if you would like to ask a question, you're welcome to press star then one Next question we have is from Chase Knickerbocker of Craig Hallum Capital. Please go ahead.

女士們先生們，提醒一下，如果您想問問題，歡迎您成為新聞明星，我們的下一個問題來自克雷格·哈勒姆資本 (Craig Hallum Capital) 的蔡斯·尼克博克 (Chase Knickerbocker)。請繼續。

Good afternoon. Thanks for taking the questions. And I just want to pass along my congratulations as well. Maybe just first for me, wonder if you had to say what's driving predominantly the outperformance here in the first half of the year, would you say it's more of new patient starts or subdue conversions from IV Thanks.

午安.感謝您提出問題。我也想轉達我的祝賀。也許首先對我來說，想知道您是否不得不說是什麼推動了今年上半年的優異表現，您會說更多的是新患者的開始或靜脈注射的轉化率下降，謝謝。

So, I would say it's a combination. I mean, the performance of the overall subcutaneous IG market is driving new patient starts. But you know, certainly the growth in the front half. The performance in our international and our domestic core businesses are doing incredibly well as well as our business development efforts and novel therapies. So, strength in all three is what we see driving the front half growth.

所以，我想說這是一個組合。我的意思是，整個皮下 IG 市場的表現正在推動新患者的開始。但你知道，肯定是前半部的成長。我們的國際和國內核心業務以及我們的業務發展努力和新療法的表現都非常出色。因此，我們認為這三者的實力推動了前半部的成長。

And maybe just on kind of the prefilled benefit that we could get from CSL canceling the vials, do you think we've seen some of that benefit already as part of the kind of outperformance in the first half may be a benefit from some increased kind of prefilled conversion or maybe just some thoughts there. Thanks.

也許只是我們可以從 CSL 取消小瓶中獲得的預填充好處，你認為我們已經看到了一些好處，作為上半年表現優異的一部分，可能是某種增加的好處預先填充的轉換或者可能只是一些想法。謝謝。

Yes. I think the prefilled launches is going as per our internal plans to date. I think we will see more upside as we get into some of our new product innovations that are one of them, I mentioned coming towards the back half of the year and the other one coming in 2025, which are tailored to benefit the prebuild users. So, I think we'll see more than I think the first half is performing as per our expectations.

是的。我認為預裝產品的發布正在按照我們迄今為止的內部計劃進行。我認為，當我們進入一些新產品創新時，我們會看到更多的好處，其中一個是我提到的將於今年下半年推出的產品，另一個是2025 年推出的產品，這些創新是專為使預製用戶受益而量身定制的。因此，我認為我們會看到上半年的表現超出我們的預期。

Yes. So it sounds like in overall SCS market growth expectations are kind of unchanged you know, things are going as you expected. Maybe just speak to guidance implying a little bit of a step down sequentially from here in revenue from the first half of the year into the second half of should we think of this as kind of conservatism? Or is there some seasonality we should think about this.

是的。因此，聽起來整個 SCS 市場的成長預期沒有變化，你知道，事情正在按照你的預期進行。也許只是談到指導意見，暗示從今年上半年到下半年的收入會依次下降一點，我們是否應該認為這是一種保守主義？或者是否有一些季節性我們應該考慮一下。

Yes. So thank you. Great question. So yes, Q3, traditionally, we see a bit of a slowdown both here in the US and internationally as vacations tend to slow down. Overall, new patient starts both from the health care provider perspective and from the patient perspective, the second thing is, as Tom mentioned to you, we had this $300,000 that was pulled into Q2 accelerated and due to the prior issue with the BSI. regulatory clearance, which we have since cleared. And then finally, we always have to consider timing of novel therapies revenues that it's our intention to complete it earlier, but working together with our pharmaceutical collaborations sometimes takes longer than we expected. So I think we look at all three of those things and of course, I wouldn't call it conservative, but I would say that we certainly hope that we have opportunities to outperform in the back half with both our further international penetration and two collaboration time.

是的。所以謝謝你。很好的問題。所以，是的，第三季度，傳統上，我們看到美國和國際上的經濟成長放緩，因為假期往往會放緩。總體而言，新患者從醫療保健提供者的角度和患者的角度開始，第二件事是，正如Tom 向您提到的，由於BSI 之前的問題，我們將這300,000 美元加速拉入第二季度。監管許可，我們已經批准了。最後，我們總是必須考慮新療法收入的時間安排，我們打算儘早完成它，但與我們的製藥夥伴合作有時需要比我們預期的時間更長的時間。因此，我認為我們會考慮這三件事，當然，我不會稱之為保守，但我想說，我們當然希望透過進一步的國際滲透和兩項合作，我們有機會在後半段表現出色時間。

And then just last from me, Linda, that was helpful. Maybe speak to kind of any plans that you have from a commercialization perspective on these new novel therapies. They're going to be launching into you guys are going to be launching into the infusion clinics here that deliver those patients administered novel therapies on the oncology asset and a rare disease and maybe just speak to kind of how you guys expect to kind of target that market and maybe early commercial. Thanks.

最後，琳達，這很有幫助。也許可以從商業化的角度談談您對這些新療法的任何計劃。他們將進入你們將進入這裡的輸液診所，為這些患者提供針對腫瘤資產和罕見疾病的新療法，也許只是談談你們希望如何達到目標那個市場，也許還有早期的商業。謝謝。

So sure, with any of our launches on our label. The most important early partnership we have is with the pharmaceutical company itself. So we work closely with them on their launch plans and ensuring that we understand their targeted messaging and we work with them to figure out where the right target and call points, whether that's a country or a specific clinic. And so that's first, and we'll continue those efforts on those new drugs we talked about. Second on we many of the specialty pharmacies that we work with today, service the rare disease drug that I referenced, which we'll plan to file by the end of Q4. And then for oncology, we expect that we will work with a distributor who's focuses and specializes in oncology clinics and for that market. But we're in the process of finalizing our commercialization plans for that drug launch for our launch with that drug. Very driving that already. Thank you.

當然，我們品牌推出的任何產品都是如此。我們最重要的早期合作關係是與製藥公司本身。因此，我們與他們密切合作制定啟動計劃，確保我們了解他們的目標訊息，並與他們合作找出正確的目標和呼叫點，無論是一個國家還是一個特定的診所。所以這是首先，我們將繼續在我們談到的新藥上做出這些努力。其次，我們今天合作的許多專業藥房都為我提到的罕見疾病藥物提供服務，我們計劃在第四季度末之前提交該藥物。然後對於腫瘤學，我們希望我們將與專注於腫瘤診所和該市場的經銷商合作。但我們正在最終確定該藥物的商業化計劃，以便我們推出該藥物。已經非常駕駛了。謝謝。

Yes, the next question we have is from Anderson Schock of B. Riley Securities. Please go ahead.

是的，我們的下一個問題來自 B. Riley Securities 的 Anderson Schock。請繼續。

Hi, this is Anderson on for Kyle. Congratulations on the great quarter and thank you for taking our questions. So first, do you have any updates on the potential expansion into Canada? I know there were some delays initially, but how is that study progressing? And when should we expect to see approval here?

大家好，我是凱爾的安德森。恭喜這個很棒的季度，並感謝您回答我們的問題。首先，您有關於可能擴展到加拿大的任何最新消息嗎？我知道最初有一些延誤，但這項研究進展如何？我們什麼時候才能獲得批准？

Yes. So we continue in our discussions with the pharmaceutical partners in those markets. So that is progressing extremely well. And the launch is really contingent upon our launch of a couple of new products, and we expect those to be completed in early 2025. So likely see a launch into Canada occur in that 2025 timeframe.

是的。因此，我們繼續與這些市場的製藥合作夥伴進行討論。所以進展非常順利。此次發布實際上取決於我們推出的幾款新產品，我們預計這些新產品將於 2025 年初完成。因此，很可能會在 2025 年向加拿大推出。

Okay, great. Thank you. And then could you just give us some more color on the shot pharmaceutical collaboration? Will they be developing new therapies for use on the Freedom pumps? And just how should we think about potential revenue contribution from this collaboration?

好的，太好了。謝謝。那麼您能給我們更多關於注射藥物合作的資訊嗎？他們會開發用於 Freedom 幫浦的新療法嗎？我們該如何看待這次合作的潛在收入貢獻？

And so first, I'll just reiterate that Sean is the world's largest prefilled device manufacturer in the world. So quite excited to announce this partnership, the partnership will focus on the use of our Freedom system platform with their with their prefilled syringes. We will focus on pipelines and looking at who we're working with jointly to ensure that the end customer, which is the pharmaceutical customer, is getting the best service of a combined device, which includes our Freedom platform and their pre-built device. We think there will be many advantages to the convenience and time required to infuse with prefilled syringes with this platform. We intend to do this at joint conferences, joint business calls, etcetera, with between the two companies. So too early to talk about commercial potential, and we're just at the start of the collaboration, but I would expect to have more of an update on that in 2025.

首先，我要重申 Sean 是世界上最大的預填充設備製造商。非常高興地宣布這一合作夥伴關係，該合作夥伴關係將重點關注我們的 Freedom 系統平台及其預充式註射器的使用。我們將專注於管道並專注於我們正在與誰共同合作，以確保最終客戶（即製藥客戶）獲得組合設備的最佳服務，其中包括我們的 Freedom 平台及其預建設備。我們認為，透過該平台進行預充式註射器輸注所需的便利性和時間將會有很多優點。我們打算透過兩家公司之間的聯合會議、聯合商務電話會議等方式來做到這一點。現在談論商業潛力還為時過早，我們的合作才剛開始，但我預計 2025 年會有更多相關更新。

Okay. Great. Thank you. That's all from us.

好的。偉大的。謝謝。這就是我們的全部。

Ladies and gentlemen, we have reached the end of the question-and-answer session. And with that, we conclude today's conference call. Thank you for joining us. You may now disconnect your.

女士們、先生們，問答環節已經結束。我們今天的電話會議到此結束。感謝您加入我們。您現在可以斷開連線。