Heron Therapeutics Inc (HRTX) 2023 Q3 法說會逐字稿

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Heron Therapeutics Q3 2023 earnings conference call. As a reminder, this conference is being recorded.

女士們先生們，美好的一天，謝謝你們的支持。歡迎參加 Heron Therapeutics 2023 年第三季財報電話會議。提醒一下，本次會議正在錄製中。

Now I'd like to turn the call over to Jeff Cohn, Executive Director, Assistant General Counsel, and Assistant Secretary. Please proceed.

現在我想將電話轉給執行董事、助理總法律顧問兼助理秘書 Jeff Cohn。請繼續。

Thank you, operator, and good afternoon, everyone. Thank you for joining us on the Heron Therapeutics conference call this afternoon to discuss the company's financial results for the third quarter ended September 30, 2023.

謝謝接線員，大家下午好。感謝您今天下午參加 Heron Therapeutics 電話會議，討論該公司截至 2023 年 9 月 30 日的第三季財務業績。

With me today from Heron are Craig Collard, Chief Executive Officer; Ira Duarte, Executive Vice President, Chief Financial Officer; Bill Forbes, Executive Vice President, Chief Development Officer; and Ryan Craig, Vice President, Marketing.

今天與我一起來自 Heron 的是首席執行官克雷格·科拉德 (Craig Collard)； Ira Duarte，執行副總裁兼財務長； Bill Forbes，執行副總裁兼首席開發長；瑞安·克雷格（Ryan Craig），行銷副總裁。

For those of you participating via conference call, slides are made available via webcast. It can also be accessed via the Investor Relations page of our website following the conclusion of today's call.

對於那些透過電話會議參加的人，可以透過網路廣播提供幻燈片。今天的電話會議結束後，您也可以透過我們網站的投資者關係頁面存取該資訊。

Before we begin, let me quickly remind you that during the course of this conference call, the company will make forward-looking statements. We caution you that any statement that is not a statement of historical fact is a forward-looking statement.

在我們開始之前，讓我快速提醒您，在本次電話會議期間，本公司將做出前瞻性陳述。我們提醒您，任何不是歷史事實陳述的陳述都是前瞻性陳述。

This includes remarks about the company's projections, expectations, plans, beliefs, and future performance, all of which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995.

這包括有關公司的預測、預期、計劃、信念和未來業績的評論，所有這些均構成前瞻性陳述，以符合 1995 年《私人證券訴訟改革法案》中的安全港條款。

These statements are based on judgment and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.

這些陳述是基於截至本次電話會議之日的判斷和分析，並受到許多重要風險和不確定性的影響，可能導致實際結果與前瞻性陳述中所述的結果有重大差異。

The risks and uncertainties associated with the forward-looking statements made at this conference call and webcast are described in the Safe Harbor statement in today's press release and in Heron's public periodic filings with the SEC. Except as required by law, Heron assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

今天新聞稿中的安全港聲明以及 Heron 向 SEC 提交的公開定期文件中描述了與本次電話會議和網路廣播中所做的前瞻性陳述相關的風險和不確定性。除法律要求外，Heron 不承擔更新這些前瞻性陳述以反映未來事件或實際結果的義務，也不打算這樣做。

And with that, I would now like to turn the call over to Craig Collard, Chief Executive Officer.

現在，我想將電話轉給執行長克雷格·科拉德 (Craig Collard)。

Thanks, Jeff. Good afternoon, and welcome to the Heron Therapeutics third quarter 2023 earnings call. Today, we are pleased to update you on our recent strategic initiatives, financial performance from the third quarter, and guidance for the rest of 2023, as well as guidance for the full year of 2024.

謝謝，傑夫。下午好，歡迎參加 Heron Therapeutics 2023 年第三季財報電話會議。今天，我們很高興向您介紹我們最近的策略舉措、第三季的財務業績、2023 年剩餘時間的指導以及 2024 年全年的指導。

Over the past six months, since joining Heron as the CEO, we have taken significant steps to rightsize our business, ensure alignment with our strategic goals. We've implemented a comprehensive streamlining of our financial processes, enhancing efficiency and accountability across the organization.

在過去的六個月裡，自從加入 Heron 擔任執行長以來，我們採取了重大措施來調整我們的業務規模，確保與我們的策略目標保持一致。我們對財務流程進行了全面精簡，提高了整個組織的效率和問責制。

As part of our commitment to operational excellence, we have successfully combined various commercial functions, eliminating redundancies, and optimizing our overall structure. This consolidation not only enhances efficiency, but also positions us to respond more effectively to market dynamics.

作為我們卓越營運承諾的一部分，我們成功地整合了各種商業功能，消除了冗餘，並優化了我們的整體結構。這種整合不僅提高了效率，而且使我們能夠更有效地應對市場動態。

Last, we are excited to share that we have developed a new strategic vision that clearly defines our goals and key targets. This vision serves as a road map for our future, guiding our efforts to achieve sustainable growth, and maximize shareholder value. The results of our actions in the short time at Heron has been substantial.

最後，我們很高興與大家分享，我們已經制定了新的策略願景，明確定義了我們的目標和關鍵目標。這個願景是我們未來的路線圖，指導我們努力實現永續成長和股東價值最大化。我們在 Heron 的短時間內所採取的行動取得了巨大的成果。

Our management team is now in place and the transformation of Heron into a profitable company is happening. We have reduced operational expenses, excluding stock comp and depreciation and amortization to $135 million in 2023 versus $182 million just last year. We anticipate a further reduction in spend that will take our operating expenses to a range of $108 million from $116 million in 2024.

我們的管理團隊現已就位，Heron 正在轉型為一家盈利的公司。我們已將營運費用（不包括股票補償和折舊及攤提）減少到 2023 年的 1.35 億美元，而去年為 1.82 億美元。我們預計支出將進一步減少，到 2024 年，我們的營運支出將從 1.16 億美元降至 1.08 億美元。

Our gross margin is also improving from 41% in 2023 to 62% (sic - see press release, "69") in 2024 and should spell in over 75% in 2025 and beyond. This change in gross margin has been due to scaling to larger batch sizes being fully realized, negotiations with our manufacturing partners, operational efficiencies, and no more product write-offs of ZYNRELEF due to it's high inventory.

我們的毛利率也從 2023 年的 41% 提高到 2024 年的 62%（原文如此 - 參見新聞稿，「69」），並且在 2025 年及以後應該會超過 75%。毛利率的這種變化是由於完全實現了更大批量的擴展、與我們的製造合作夥伴的談判、營運效率以及 ZYNRELEF 不再因庫存高而註銷產品。

With our capital raise back in the summer and our anticipated cash balance of over $65 million at year's end, combined with our spend reduction, we can now illustrate to our investors a pathway to positive EBITDA by Q4 2024. Based on our current plan, we do not anticipate needing any additional capital raises for the foreseeable future.

隨著我們在夏季籌集資金，預計年底現金餘額將超過6500 萬美元，再加上我們的支出削減，我們現在可以向投資者展示到2024 年第四季度實現正EBITDA 的途徑。根據我們目前的計劃，我們預計在可預見的未來不需要任何額外的融資。

Last, as we have created operational efficiency within our business and laid out our plan internally, we are beginning to see the impact in our product sales. Over the last eight weeks, both ZYNRELEF and APONVIE had hit all-time highs in unit sales. We believe this momentum will only continue as we move closer to our anticipated label expansion, launch of the VAN, and then ultimately, the prefilled syringe, which are all hitting their development timelines.

最後，隨著我們在業務中提高營運效率並在內部製定計劃，我們開始看到對產品銷售的影響。過去八週，ZYNRELEF 和 APONVIE 的銷量都創下歷史新高。我們相信，隨著我們越來越接近預期的標籤擴展、VAN 的推出，以及最終的預充式註射器，這種勢頭只會持續下去，這些都已達到了開發時間表。

Moving to product performance. The oncology care franchise continues to provide a stable pace of revenue for Heron, contributing $26.7 million in net sales for the quarter and $79.9 million in net sales year to date. Net product sales of CINVANTI for the quarter were $23.3 million, which increased from $21.2 million in the same period in 2022. Net product sales of SUSTOL were $3.4 million, which increased from $2.7 million for the same period in 2022.

轉向產品性能。腫瘤護理特許經營業務繼續為 Heron 提供穩定的收入，本季淨銷售額貢獻 2,670 萬美元，年初至今貢獻淨銷售額 7,990 萬美元。 CINVANTI 該季度的產品淨銷售額為 2,330 萬美元，高於 2022 年同期的 2,120 萬美元。SUSTOL 的產品淨銷售額為 340 萬美元，高於 2022 年同期的 270 萬美元。

The acute care franchise continues to grow, achieving $4.7 million in net sales for the quarter and $12.9 million in net sales year to date. We have solidified our new strategic plan and are excited to see these initiatives implemented and contribute to the continued growth of our products. Net product sales of APONVIE for the quarter were $350,000. Net product sales of ZYNRELEF for the quarter were $4.4 million compared to $2.7 million for the same period in 2022.

急診特許經營業務持續成長，本季淨銷售額達到 470 萬美元，年初至今淨銷售額達到 1,290 萬美元。我們已經鞏固了新的策略計劃，很高興看到這些舉措得到實施並為我們產品的持續成長做出貢獻。 APONVIE 本季的產品淨銷售額為 350,000 美元。 ZYNRELEF 本季的產品淨銷售額為 440 萬美元，而 2022 年同期為 270 萬美元。

I'll now turn the call over to Dr. Ryan Craig, our Head of Marketing, to give you a brief view of our commercial strategy. Go ahead, Ryan.

我現在將把電話轉給我們的行銷主管 Ryan Craig 博士，讓您簡要介紹我們的商業策略。來吧，瑞安。

Thank you, Craig. We have solidified our strategic plan, and we're excited to see it implemented and grow the acute care franchise. Our sales team is exceptional and the alignment across our commercial organization has never been stronger.

謝謝你，克雷格。我們已經鞏固了我們的策略計劃，我們很高興看到它的實施並發展急診護理專營權。我們的銷售團隊非常出色，整個商業組織的一致性也從未如此強大。

The vision for acute care is to own the perioperative space, as both APONVIE and ZYNRELEF offer a best-in-class one-two punch supported by a clinical profile. we are promoting innovative solutions for two of the most burdensome challenges associated with surgical procedures, post-op nausea and vomiting and pain.

急性照護的願景是擁有圍手術期空間，因為 APONVIE 和 ZYNRELEF 都提供由臨床資料支援的一流一二沖床。我們正在推廣創新解決方案，以應對與外科手術相關的兩個最棘手的挑戰，即術後噁心、嘔吐和疼痛。

For APONVIE, our initial focus is above-the-waist surgical procedures. These procedures such as bariatric, ENT, neurological and plastics, are of a higher sensitivity to post-op nausea and vomiting and PONV can cause significant concerns if not properly managed. Our early successes with APONVIE have indicated that this is a logical, receptive starting point to get on formulary and a proven ability to expand beyond the starting point to other surgical lines.

對於 APONVIE，我們最初的重點是腰部以上的手術。這些手術，如減重、耳鼻喉、神經和整形手術，對術後噁心和嘔吐的敏感度較高，如果管理不當，PONV 可能會引起嚴重問題。我們在 APONVIE 方面的早期成功表明，這是進入處方集的一個合乎邏輯的、容易接受的起點，並且經過驗證的能力可以超越該起點擴展到其他手術系列。

In addition, to our clinical profile, the 2020 PONV guidelines also recommend using three different agents with distinct pathways which supports the addition of APONVIE's protocols. With ZYNRELEF, our commercial execution was wide ranging and expanded across many specialties with varying opportunities of success.

此外，根據我們的臨床概況，2020 PONV 指南還建議使用三種具有不同途徑的不同藥物，這支持添加 APONVIE 的方案。透過 ZYNRELEF，我們的商業執行範圍廣泛並擴展到許多專業，並具有不同的成功機會。

Based on our growth, current base of business as well as growth opportunity, we have determined orthopedic surgeries to be our primary focus. Our execution will be aligned with the customer base more significantly moving forward for many reasons.

根據我們的成長、目前的業務基礎以及成長機會，我們確定骨科手術是我們的主要重點。出於多種原因，我們的執行將更顯著地與客戶群保持一致。

First, the most significant pain patients may experience is associated with orthopedic procedures versus some of the other indications. Additionally, orthopedic surgeons tend to do a higher volume of procedures, which would include the anticipated indication for spine and shoulder, should we receive sNDA approval on January 23 from the FDA.

首先，與其他一些適應症相比，患者可能經歷的最嚴重的疼痛與骨科手術有關。此外，如果我們在 1 月 23 日收到 FDA 的 sNDA 批准，骨科醫生往往會進行更多的手術，其中包括脊椎和肩部的預期適應症。

Focusing on orthopedic surgery also create an opportunity to partner with distributor representatives, which we have piloted in the field and had terrific success. APONVIE was launched in March of this year, and we are continuing to gain traction in our targeted institutions. We continue to identify advocate specialists that aim to address the burden of PONV and improve its treatment paradigm.

專注於骨科手術也創造了與經銷商代表合作的機會，我們已經在該領域進行了試點並取得了巨大的成功。 APONVIE 於今年 3 月推出，我們正在繼續吸引目標機構的注意。我們繼續尋找旨在解決 PONV 負擔並改善其治療模式的倡議專家。

Currently, we have 66 P&T reviews requested by targeted customers, 10 P&T reviews that have been scheduled and confirmed with the date, and 9 new P&T approvals alone in the month of October. The process of requesting P&T confirming with a date and ultimately gaining approval can take four to six months in some case. This is where we are focused currently building a wide opportunity base that will result in consistent ordering at increasing volume.

目前，我們有 66 項目標客戶要求的 P&T 審查，10 項已安排並確認日期的 P&T 審查，僅 10 月份就有 9 項新的 P&T 批准。在某些情況下，要求 P&T 確認日期並最終獲得批准的過程可能需要四到六個月的時間。這就是我們目前關注的重點，建立廣泛的機會基礎，從而以不斷增加的數量實現一致的訂購。

To date, we have had 156 accounts complete this process and ultimately order APONVIE. Other than the 156 new accounts, we have selected a few accounts as examples that provide encouraging signs of growth. Initial ordering in these four accounts has turned into consistent ordering at increasing levels. These accounts have executed on the plan articulated previously, starting in one surgical line like bariatric surgery, seeing positive results, communicating those results organically to other surgical line and adoption, then expand.

到目前為止，我們已有 156 個帳戶完成了此流程並最終訂購了 APONVIE。除了 156 個新帳戶之外，我們還選擇了一些提供令人鼓舞的成長跡象的帳戶作為範例。這四個帳戶的最初訂購已轉變為不斷增加的一致訂購。這些帳戶是按照先前闡述的計劃執行的，從減肥手術等一個手術線開始，看到積極的結果，將這些結果有機地傳達給其他手術線和採用，然後擴大。

Our strategic plan is aligned to this prudent scenario as well as others. And we are excited about what's to come as awareness grows. Momentum is building with recent trends of ZYNRELEF. Our streamlined focus on orthopedic procedures is beginning to produce results, with our most recent data week ending November 10 represented an all-time high in normalized year.

我們的策略計劃與這種謹慎的情況以及其他情況一致。隨著意識的增強，我們對即將發生的事情感到興奮。 ZYNRELEF 的最新趨勢正在增強勢頭。我們對骨科手術的簡化關注已開始產生成果，截至 11 月 10 日的最新數據週創下了標準化年份的歷史新高。

Additionally, current eight-week volume over the prior eight weeks represents a 16% growth rate. We are encouraged by this recent trend trajectory, and we fully expect to continue as we continue to execute against our strategy in the fourth quarter and beyond.

此外，目前八週的交易量較前八週增加了 16%。我們對最近的趨勢軌跡感到鼓舞，並且我們完全期望在第四季度及以後繼續執行我們的策略時繼續下去。

On top of the recent trends, there are significant opportunities to increase ZYNRELEF adoption through near-term regulatory and development milestones. First is the sNDA PDUFA date scheduled for January 23, 2024. We anticipate a positive response from the FDA and are excited to offer ZYNRELEF to additional patients that may benefit from the added indication. Should we receive approval, it would increase the opportunity from approximately 7 million procedures covered by our current label to nearly 13 million procedures.

除了最近的趨勢之外，還有透過近期監管和開發里程碑來提高 ZYNRELEF 採用率的重大機會。首先是 sNDA PDUFA 日期定於 2024 年 1 月 23 日。我們預計 FDA 會做出積極回應，並很高興向更多可能從新增適應症中受益的患者提供 ZYNRELEF。如果我們獲得批准，機會將從我們目前標籤涵蓋的約 700 萬例手術增加到近 1300 萬例手術。

Secondly, the Vial Access Needle is currently in development and planned for launch in September of 2024. This improvement will improve withdrawal time from greater than 1 minute to 20 to 30 seconds. A market research conducted in Q3 as well as current customer feedback, this improvement is significant and will expand utilization.

其次，小瓶接入針目前正在開發中，計劃於 2024 年 9 月推出。這項改進將使抽取時間從 1 分鐘以上縮短到 20 至 30 秒。根據第三季進行的市場研究以及目前的客戶回饋，這項改進非常顯著，並將擴大利用率。

Lastly, the prefilled syringe is in development and will represent the most meaningful improvement in ZYNRELEF preparation and administration. It takes any time spent in the OR on withdrawal time or preparation out of the equation as ZYNRELEF would immediately be available for application in this product in hand.

最後，預充式註射器正在開發中，它將代表 ZYNRELEF 製備和給藥最有意義的改進。由於 ZYNRELEF 將立即可用於手中的該產品，因此在手術室中花費的任何時間都需要在退出時間或準備上進行。

Now I'll turn it over to Ira Duarte, our Chief Financial Officer.

現在我將把它交給我們的財務長 Ira Duarte。

Thank you, Ryan. Craig has covered our product performance in his comments, and I will just add a few additional points about our Q3 2023 results.

謝謝你，瑞安。克雷格在他的評論中介紹了我們的產品性能，我將就我們 2023 年第三季的業績添加一些額外的要點。

Our product gross profit for the quarter was $13.2 million and $37.6 million for the nine months ended September 30, 2023, representing 42% and 41% of net revenue, respectively. These margins were negatively impacted by write-offs of ZYNRELEF inventory during the nine months ended September 30, 2023. We do not anticipate any large ZYNRELEF write-offs in the future.

截至 2023 年 9 月 30 日止的九個月，我們本季的產品毛利潤為 1,320 萬美元和 3,760 萬美元，分別佔淨收入的 42% 和 41%。截至 2023 年 9 月 30 日的九個月期間，這些利潤率受到 ZYNRELEF 庫存沖銷的負面影響。我們預計未來不會出現任何大規模的 ZYNRELEF 沖銷。

SG&A expenses for the three months and nine months ended September 30, 2023, were $24.6 million and $93 million, respectively, compared to $28.2 million and $93.3 million in the same period of 2022.

截至2023年9月30日的三個月和九個月的SG&A費用分別為2,460萬美元和9,300萬美元，而2022年同期為2,820萬美元和9,330萬美元。

Research and development expenses were $13.6 million and $44.9 million for the three and nine months ended September 30, 2023, compared to $25.5 million and $96.4 million in the comparable period of 2022.

截至2023年9月30日的三個月和九個月，研發費用分別為1,360萬美元和4,490萬美元，而2022年同期的研發費用為2,550萬美元和9,640萬美元。

The decrease in spend was primarily related to decreases in costs related to ZYNRELEF as production scale, validation activities, and raw material qualifications were completed in 2022. In addition, overall personnel and lay-off cost decreased due to the reductions in force implemented in June 2022 and June 2023. We believe we can continue to reduce costs moving forward in this area as we continue to increase efficiency.

支出減少主要與 ZYNRELEF 相關成本下降有關，因為生產規模、驗證活動和原材料鑑定已於 2022 年完成。此外，由於 6 月實施的裁員，總體人員和裁員成本下降2022 年和2023 年6 月。我們相信，隨著我們繼續提高效率，我們可以繼續降低該領域的成本。

The net loss of $25 million for Q3 2023 and $41.9 million for the comparable period in 2022. Looking to total year-to-date net loss, 2023 is a net loss of $99.8 million compared with $152.2 million in the comparable period of 2022.

2023 年第三季的淨虧損為2,500 萬美元，2022 年同期的淨虧損為4,190 萬美元。就年初至今的淨虧損總額而言，2023 年淨虧損為9,980 萬美元，而2022 年同期的淨虧損為1.522 億美元。

I'd now like to give a little bit more clarity on what Craig has been talking about earlier and would like to walk you through the last three quarters and the measures we have taken to reduce our overall operational spend and cash burn.

現在，我想更清楚地說明克雷格之前所說的內容，並向您介紹過去三個季度的情況以及我們為減少整體營運支出和現金消耗而採取的措施。

We began implementing our corporate restructuring plan in early June, which included several cost savings strategies, including a reduction in force as well as overall company-wide spend reduction. We now have much more visibility into our operational spend and see a clear path to profitability.

我們於 6 月初開始實施公司重組計劃，其中包括多項成本節約策略，包括減少人員以及全公司範圍內的總體支出削減。現在，我們對營運支出有了更多的了解，並看到了清晰的獲利之路。

If you look at the slide from left to right, you will see our overall operational spend in Q1 2023 was about $46 million, which we reduced to $41 million after excluding the highlighted reorganization charges of $30 million. We further reduced the spend to $34 million in Q3 2023 after excluding the highlighted reorganization charge of $4.1 million.

如果您從左到右查看投影片，您會發現我們 2023 年第一季的整體營運支出約為 4,600 萬美元，在排除突出顯示的 3,000 萬美元重組費用後，我們將其減少至 4,100 萬美元。在排除突出的 410 萬美元重組費用後，我們在 2023 年第三季將支出進一步減少至 3,400 萬美元。

You can see on the slide that our operating loss excluding stock compensation and depreciation and amortization and the previously mentioned one-time charges, our overall operating cash burn decreased from $90 million in Q1 2023 to $7.2 million in Q2 2023 and $6 million in Q3 2023.

您可以在幻燈片中看到，我們的營運虧損不包括股票補償、折舊和攤銷以及先前提到的一次性費用，我們的整體營運現金消耗從2023 年第一季的90​​00 萬美元減少到2023年第二季的720 萬美元，2023 年第三季的600 萬美元。

Our 2023 operating spend, excluding stock compensation, depreciation and amortization, and the $17.1 million in reorganization costs, will be around $180 million. We believe our operational run rate, excluding stock compensation and depreciation and amortization going forward will be between $108 million to $116 million, and cash burn will decrease every quarter as we have stabilized our spend and revenues have been increasing every quarter.

我們 2023 年的營運支出（不包括股票補償、折舊和攤提以及 1,710 萬美元的重組成本）約為 1.8 億美元。我們相信，我們的營運運作率（不包括股票補償和折舊及攤提）將在1.08 億美元至1.16 億美元之間，隨著我們穩定支出且收入每季都在增加，每季的現金消耗將會減少。

Moving now onto our guidance for the rest of 2023 and 2024. On the left of this slide, we are showing anticipated results for Q4 2023, which indicates net revenues between $30 million and $32 million and EBITDA, excluding stock compensation loss between $10 million and a loss of $6 million. We anticipate exiting 2023 with a minimum cash and cash equivalent of $65 million.

現在轉向我們對2023 年剩餘時間和2024 年的指導。在這張投影片的左側，我們顯示了2023 年第四季的預期結果，其中顯示淨收入在3,000 萬美元到3,200 萬美元之間， EBITDA 不包括在1000 萬美元到1000 萬美元之間的股票補償損失。損失600萬美元。我們預計 2023 年退出時的現金和現金等價物至少為 6,500 萬美元。

We are guiding to revenue of $138 million to $158 million for 2024 and improved gross margins between 68% to 70%. Our operating spend, excluding stock compensation, depreciation, and amortization is anticipated to be between $108 million to $116 million. And EBITDA, excluding stock compensation, will be between a loss of $22 million to income of $3 million.

我們預計 2024 年營收將達到 1.38 億至 1.58 億美元，毛利率將提高 68% 至 70%。我們的營運支出（不包括股票補償、折舊和攤提）預計在 1.08 億至 1.16 億美元之間。扣除股票報酬後，EBITDA 將在虧損 2,200 萬美元到營收 300 萬美元之間。

I would like to reiterate that we anticipate getting to positive EBITDA in Q4 2024, and based on this, our strong balance sheet and our current operational plan, we do not anticipate having to raise any additional capital.

我想重申，我們預計在 2024 年第四季實現正 EBITDA，基於此、我們強大的資產負債表和當前的營運計劃，我們預計無需籌集任何額外資本。

Back to you Craig.

回到你，克雷格。

As we move to the key items from today's call, you can probably sense the change in confidence and our voices about this business. Our business economy is set and we have a team in place that is executing on the balance sheet to get us the profitability without any expected need for further capital raises.

當我們轉向今天電話會議的關鍵內容時，您可能會感覺到我們對這項業務的信心和聲音的變化。我們的商業經濟已經確定，我們有一個團隊正在資產負債表上執行，以使我們實現盈利，而無需進一步籌集資金。

Our operating expenses, gross margin, and EBITDA are all moving in the right direction on the path to profitability. The oncology franchise continues to outperform, and we are raising guidance for 2023 from $99 million to $103 million to a range of $104 million to $106 million.

我們的營運費用、毛利率和 EBITDA 都在朝著獲利的正確方向發展。腫瘤專營業務持續表現出色，我們將 2023 年的指引從 9,900 萬美元至 1.03 億美元提高到 1.04 億美元至 1.06 億美元。

Our momentum with the acute products is strong as well, as ZYNRELEF and APONVIE have both achieved record unit volume over the last eight weeks. And last, we have a label expansion and the VAN being launched for ZYNRELEF, which should both be significant growth drivers for the product.

我們在急性產品方面的勢頭也很強勁，ZYNRELEF 和 APONVIE 在過去八週內都創下了創紀錄的單位銷售量。最後，我們為 ZYNRELEF 推出了標籤擴展和 VAN，這都應該成為該產品的重要成長動力。

I would now like to open the line for questions.

我現在想開通提問熱線。

Carl Byrnes, North Capital Market.

卡爾伯恩斯，北方資本市場。

Great, congratulations on the progress and thanks for the questions. First with the gross profit margin for the third quarter excluding the inventory write-offs, it would be 66%, if I recall from the press release. And it looks like you're giving guides on the fourth quarter at 62% for the year '24 of 68% to 70%.

太好了，祝賀您取得的進展並感謝您的提問。首先，如果我記得新聞稿中不包括庫存沖銷的第三季毛利率，則為 66%。看起來你給的指引是第四季的 62%，24 年的指引是 68% 到 70%。

I'm wondering if there's mixed issue, what the nuance is between the third quarter and the fourth quarter at 62%. And how do you see gross profit margin progressing over time beyond 2024 in terms of peak gross profit target or margin target?

我想知道是否存在混合問題，第三季和第四季 62% 之間的細微差別是什麼。您如何看待 2024 年後毛利率在高峰毛利目標或利潤率目標的進展？

Yeah, Carl. Thanks for the question. Again, with our gross margin, if you think about CINVANTI first, it's going to have the largest impact because of just total revenue. We basically are making the product currently at two different manufacturers. And 2022, really until the start of '23, we were finishing scale up and so forth, going from a 400 kilogram batch to a 1,000 kilogram.

是的，卡爾。謝謝你的提問。同樣，就我們的毛利率而言，如果您首先考慮 CINVANTI，那麼由於總收入，它將產生最大的影響。目前我們基本上是在兩個不同的製造商生產該產品。到 2022 年，直到 23 年初，我們才完成了規模擴大等工作，從 400 公斤批量增加到 1,000 公斤。

So, you had a price blend with those two batch sizes. And then beyond that, our primary manufacturer is Alchemy, working now in a 1,000-kilogram batch, and then our secondary manufacturer is at Curia, where we do a secondary and we make it 300 kilograms, so you also have a blend there.

因此，您對這兩個批量大小進行了價格混合。除此之外，我們的主要製造商是Alchemy，現在批量生產1,000 公斤，然後我們的二級製造商在Curia，我們在那裡進行二級生產，產量為300 公斤，所以你也可以在那裡進行混合。

So as that sorts out a bit, that's why it will continue to be more positive moving forward. And again, as we get into the outer years, we will have a, like I say, total gross margin of all products in that mid-70s range.

因此，隨著這一點的解決，這就是為什麼它將繼續更加積極地向前發展。再說一遍，當我們進入最後幾年時，就像我說的那樣，我們將擁有 70 年代中期所有產品的總毛利率。

Again, ZYNRELEF is pretty fixed. But we just had the write-offs that affected that. So there's really no big changes there. The only other product that will be affected in the future with scale and that type of thing is APONVIE, and we're going from 400 kilograms to 1,000 kilogram batch there as well, which should take those margins right at that lower 70s%. So again, that's why I say as a whole, we'll be in that mid-70s to possibly 80% range as we move forward.

同樣，ZYNRELEF 已經非常固定了。但我們只是進行了影響這一點的沖銷。所以那裡確實沒有什麼大的改變。未來唯一會受到規模和此類影響的產品是 APONVIE，我們也將從 400 公斤批量生產到 1,000 公斤批次，這應該會將這些利潤率控制在較低的 70% 左右。再說一次，這就是為什麼我說作為一個整體，隨著我們的前進，我們將處於 70 年代中期到可能 80% 的範圍內。

Excellent. That's very helpful. And then just a follow-up. I mean, clearly, you could be profitable tomorrow if you were just to focus on the CINV franchise. But clearly, the growth is from the acute care segment with APONVIE and ZYNRELEF.

出色的。這非常有幫助。然後只是後續行動。我的意思是，很明顯，如果您只專注於 CINV 特許經營權，明天您就可以獲利。但顯然，成長來自 APONVIE 和 ZYNRELEF 的急診護理領域。

So I'm wondering what your thoughts are in terms of peak sales potential for ZYNRELEF and APONVIE and how the progression might look over time from your internal analysis? Thanks.

所以我想知道您對 ZYNRELEF 和 APONVIE 的峰值銷售潛力有何看法，以及根據您的內部分析，隨著時間的推移，進展情況如何？謝謝。

Yes. No, it's an interesting point because I think -- and although you look at this from an investor viewpoint, the oncology side of the business really acts as a bit of a hedge, if you will, protecting your investment. And why -- what I mean by that, and I think you're hitting on this is that if this were just about profitability, I mean, we could be a common oncology company tomorrow and be EBITDA-positive within the end of the week. And -- but again, that's not really where we're going. We think there's a much bigger story here.

是的。不，這是一個有趣的觀點，因為我認為——儘管你從投資者的角度來看這一點，但如果你願意的話，該業務的腫瘤學方面確實起到了一定的對沖作用，可以保護你的投資。為什麼 - 我的意思是，我認為你的意思是，如果這只是關於盈利能力，我的意思是，我們明天可能會成為一家普通的腫瘤公司，並在本週末內實現 EBITDA 為正值。而且——但是，這並不是我們真正要去的地方。我們認為這裡有一個更大的故事。

And really, the growth story's with the two products that have the ability to dominate the perioperative space, and that's APONVIE and ZYNRELEF, which, again, we think could be multi-hundred million dollar products. If you just look at the market size, and again, we feel with some of these things that we're doing now with -- certainly with ZYNRELEF, with the VAN, the expanded label and then ultimately the prefilled syringe.

事實上，成長的故事在於有能力主導圍手術期領域的兩種產品，那就是 APONVIE 和 ZYNRELEF，我們再次認為這可能是數億美元的產品。如果你只看市場規模，我們會再次感受到我們現在正在做的一些事情——當然是 ZYNRELEF、VAN、擴展標籤以及最終的預充式註射器。

So again, it's going to take a little time to get there, but there's a real growth story here on the acute side of the business. And again, the beauty being that then you've got a base of business that's generating capital that continues to be more profitable.

再說一次，實現這一目標還需要一些時間，但在業務的尖銳方面有一個真正的成長故事。再說一次，美妙之處在於，你擁有了一個可以產生資本的業務基礎，並且可以繼續獲得更多利潤。

Great. Thanks so much. And again, congratulations on the progress.

偉大的。非常感謝。再次恭喜您的進展。

Thanks, Carl.

謝謝，卡爾。

Boris Peaker, TD Cowen.

鮑里斯·皮克，TD·考恩。

Thanks very much. This is Nick on for Boris. Just a couple from me on ZYNRELEF. First, with the slow growth of ZYNRELEF to date so far, really, what's driving that 48% year-over-year increase in acute care franchise? And on that same note, does that have to do mainly with the VAN and the sNDA?

非常感謝。這是鮑里斯的尼克。我在 ZYNRELEF 上分享了一些。首先，到目前為止，ZYNRELEF 的成長緩慢，到底是什麼推動了急診特許經營業務年增 48%？同樣，這是否主要與 VAN 和 sNDA 有關？

And how quickly do you think that those two will have an effect, like specifically, how quickly will the VAN be distributed? How quickly will doctors pick up the new procedures for the sNDA? Thanks.

您認為這兩者會多快產生效果，具體來說，VAN 的發行速度有多快？醫生將多快接受 sNDA 的新程序？謝謝。

Yeah. So again, we feel pretty confident with 48% growth. Again, especially where the product is trending now. We've done a few days in the field with targeting, alignment, and so on and so forth.

是的。因此，我們對 48% 的成長充滿信心。再說一遍，尤其是現在該產品的流行趨勢。我們已經在現場進行了幾天的定位、調整等工作。

And so if you look at then the sNDA which is going to expand the indications, and again, I think assuming PDUFA date of January 23 between now and then, there's obviously some training and that type of thing that we'll be doing in prep with that. And so that should be felt fairly quickly. And then shortly after that, as you mentioned, we've got the VAN coming in September.

因此，如果您查看將擴大適應症的 sNDA，我認為假設從現在到那時 PDUFA 日期為 1 月 23 日，顯然我們將在準備過程中進行一些培訓和此類活動接著就，隨即。所以應該很快就能感受到這一點。不久之後，正如您所提到的，我們將在 9 月推出 VAN。

And our plan is to try to lead the initial kits that are out there now as far as the inventory, if you will, with ZYNRELEF. And then launch that new kit where it's a little bit more of a seamless transition. And so that should be felt pretty neatly after that.

如果您願意的話，我們的計劃是嘗試使用 ZYNRELEF 來引導現有的初始套件的庫存。然後推出新套件，實現無縫過渡。所以在那之後應該會感覺很清楚。

And the reason that's so important, and again what we've learned in our market research and the time we've been spending with the reps is that the case management for this product due to the prep of the product is really difficult.

這麼重要的原因是，我們在市場研究中以及與銷售代表一起度過的時間中再次了解到，由於產品的準備，該產品的案例管理確實很困難。

And so if you can improve that and what the VAN does, it not only improves the sterility issue, but it also improves the pool of the product and just the mechanism of it, if you will, it really simplifies that.

因此，如果你能改進這一點以及 VAN 的功能，它不僅可以改善無菌問題，而且還可以改進產品池及其機制，如果你願意的話，它確實可以簡化這一點。

And we think that will really help us with the case management piece, allowing our reps to spend less time in the OR handling through surgeries and getting some other positions and expanding and growing the product.

我們認為這將真正幫助我們完成病例管理工作，讓我們的代表在手術室處理手術上花費更少的時間，並獲得一些其他職位以及擴大和發展產品。

And so it makes that problem much better. And then ultimately, as we move towards a prefilled syringe -- the beauty of the prefilled syringe -- that it really -- it's just as simple as it takes the device aspect out of the drug. So instead of us being a device-drug type of combination, we become just a drug.

所以它讓這個問題變得更好。最終，當我們轉向預充式註射器時——預充式註射器的美妙之處——它確實如此——它就像將設備方面從藥物中剔除一樣簡單。因此，我們不再是一種設備與藥物的組合，而是成為一種藥物。

If you look at our drug on a clinical -- just clinically versus other things around the market, it really does have a superior play there as far as the clinical data and what it does and so forth. And that's where we get really a lot of good feedback, which is why we're so positive on this.

如果你看看我們的藥物在臨床上的表現——只是與市場上的其他藥物相比，它確實在臨床數據和作用等方面具有優越的作用。這就是我們得到很多良好反饋的地方，這就是我們對此如此積極的原因。

That's very helpful. And then just a follow-up question. On -- so you mentioned that the sNDA that in January will lead to about 13 million procedures in total now with everything. How many of those would then be orthopedic procedures?

這非常有幫助。然後是一個後續問題。您提到 1 月的 sNDA 將導致總共約 1300 萬個程式。其中有多少是骨科手術？

Yeah. So probably -- this is Ryan, Craig. So out of the additional 5 million to 6 million procedures, probably about 70% of them are going to be ortho. And so that's what -- when Craig was speaking to our traction, we've got 60% of our current business on ZYNRELEF is orthopedic procedures as well.

是的。所以很可能——這是瑞安，克雷格。因此，在額外的 500 萬至 600 萬例手術中，約 70% 可能是正位手術。所以，當 Craig 談到我們的吸引力時，我們目前在 ZYNRELEF 上的業務有 60% 也是骨科手術。

So as soon as we gain approval -- anticipated approval by the end of January should be a seamless communication point for us. That's where we've had the most success to date, and it's obviously aligned to our strategy as well.

因此，一旦我們獲得批准——預計在一月底獲得批准，對我們來說應該是一個無縫的溝通點。這是我們迄今為止最大成功的地方，而且它顯然也符合我們的策略。

Got it. Thanks very much.

知道了。非常感謝。

Thank you. Thanks, Nicholas.

謝謝。謝謝，尼古拉斯。

Serge Belanger, Needham & Company.

謝爾蓋貝蘭格 (Serge Belanger)，李約瑟公司。

Hi, this is Serge. A couple of follow-up questions on ZYNRELEF. I assume the orthopedic focus mostly consists of knee and hip surgeries. Curious what you're competing against now? Is it generic bupivacaine or EXPAREL?

嗨，這是塞爾吉。關於 ZYNRELEF 的幾個後續問題。我認為骨科重點主要包括膝蓋和臀部手術。好奇你現在正在跟什麼競爭？它是普通布比卡因還是 EXPAREL？

And then with the label expansion, what additional orthopedic procedures do you expect that will allow you to target once we get past January, assuming approval?

然後，隨著標籤的擴展，您預計什麼額外的骨科手術可以讓您在一月過後（假設獲得批准）後實現目標？

Yeah. So I think you're right from a competitive standpoint. I mean, it's typically bupivacaine or EXPAREL, a lot of times now with EXPAREL being a nerve block-type scenario. So that could be -- an anesthesiologist is involved in that.

是的。所以我認為從競爭的角度來看你是對的。我的意思是，它通常是布比卡因或 EXPAREL，現在很多時候 EXPAREL 是神經阻斷類型的場景。所以這可能是－－麻醉師參與其中。

But the beauty of this product is that once it's used and the clinical results are shown, we really do get a lot of buy in from the orthopedic surgeons. And so we've had our most -- really, the most success there.

但該產品的美妙之處在於，一旦使用並顯示出臨床結果，我們確實得到了骨科醫生的大力支持。所以我們在那裡取得了最大的成功。

And the other piece that's probably worth mentioning is that this is where you have the majority of real pain events within surgery.

另一件可能值得一提的事情是，這是手術中大部分真實疼痛事件發生的地方。

Hip and knee can be extremely painful. So again, we think our product is very conducive for that space. In a funny way though, yes, that's our competitors. But again, our issue is not as much with the competitors clinically as it has been the own prep of our product. And that's why I continue to stress demand and so forth.

臀部和膝蓋可能會非常疼痛。因此，我們再次認為我們的產品非常有利於該領域。但有趣的是，是的，那是我們的競爭對手。但同樣，我們的問題不在於臨床上的競爭對手，而在於我們產品本身的準備。這就是為什麼我繼續強調需求等等。

And so with the expanded label, we immediately -- we hope will pick up shoulders. And so that will be a direct -- any physician who's doing orthopedic can move right into shoulders with our products, that should be immediate.

因此，隨著品牌的擴大，我們希望能夠立即振作起來。所以這將是一個直接的——任何從事骨科的醫生都可以直接使用我們的產品，這應該是立竿見影的。

And then we feel like closely related will hopefully be spine, which again takes us to a different physician group, but a very similar category as far as an area we think we can do quite well with.

然後我們覺得密切相關的將是脊柱，這再次將我們帶到了一個不同的醫生群體，但就我們認為我們可以做得很好的領域而言，這是一個非常相似的類別。

Okay. And then in terms of potential partnership, you view that as a kind of a nice to have or a priority going forward --?

好的。然後就潛在的合作夥伴關係而言，您認為這是一種美好的事情或未來的優先事項—？

No, it's a priority. Yeah, it's a great question because, again, going back -- I know I keep repeating myself, but the prep of the product and so forth is that if you think about drug reps in general, they are generally not in OR suite.

不，這是一個優先事項。是的，這是一個很好的問題，因為，再一次，我知道我一直在重複自己，但產品的準備等等是，如果你考慮一下一般的藥品代表，他們通常不在手術室中。

However, in OR suites, specifically the ortho space suites are the medical device reps. They're based in all these surgeries. And so for us, we've done this in a few different territories and had success where we have a partnership with a distributor rep.

然而，在手術室中，特別是在正交空間套件中，醫療設備代表。它們以所有這些手術為基礎。因此，對我們來說，我們已經在幾個不同的地區做到了這一點，並在與經銷商代表合作的情況下取得了成功。

So our view is if we did that on a national basis and could get let's say, a group of 500 or 600 representatives that could complement and be there for case management, it's just an absolutely huge win for us, especially as you look at introducing demand, which should improve upon that anyway. And so to us, it makes all the sense in the world. It is a priority.

因此，我們的觀點是，如果我們在全國範圍內這樣做，並且可以得到一個由500 或600 名代表組成的小組，可以補充並參與案件管理，這對我們來說絕對是一個巨大的勝利，特別是當你考慮引入需求，無論如何，這應該會有所改善。所以對我們來說，這在世界上是有意義的。這是一個優先事項。

Okay. Well, thank you. And congrats on the progress and appreciate all the numbers you gave tonight.

好的。嗯，謝謝。恭喜您取得的進展，並感謝您今晚提供的所有數字。

Well, thanks, Serge. We appreciate it.

嗯，謝謝，塞爾吉。我們很感激。

There are no further questions at this time. I'd like to turn the call over to Craig Collard for closing remarks.

目前沒有其他問題。我想將電話轉給克雷格·科拉德（Craig Collard）做結束語。

Thank you, operator. I'd just like to thank everyone for joining the call, and we do appreciate your patience. We think we're making really big strides here with the company and really beginning to turn this around, and we look forward to next quarter's call. Thank you.

謝謝你，接線生。我謹感謝大家加入通話，我們非常感謝您的耐心等待。我們認為我們與公司一起取得了巨大的進步，並真正開始扭轉局面，我們期待下個季度的電話會議。謝謝。

Ladies and gentlemen, that concludes today's conference call. Thank you for your participation. You may now disconnect. Goodbye.

女士們先生們，今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。再見。