Heron Therapeutics Inc (HRTX) 2024 Q2 法說會逐字稿

Thank you for standing by. My name is Jeremaine, and I will be your conference operator today. At this time, I would like to welcome everyone to Heron Therapeutics Q2 2024 conference call. (Operator Instructions) I would now like to turn the call over to Melissa Jarel, Executive Director, Legal, please go ahead.

謝謝你的支持。我叫 Jeremaine，今天我將擔任你們的會議操作員。此時此刻，我歡迎大家參加 Heron Therapeutics 2024 年第二季電話會議。（操作員指示）我現在想將電話轉給法務執行總監 Melissa Jarel，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 quarter ended June 30, 2024.

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 2024 年 6 月 30 日的季度財務業績。

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 Kevin Warner, Senior Vice President, Medical Affairs Strategy and Engagement.

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；凱文‧沃納 (Kevin Warner)，醫療事務策略與參與資深副總裁。

For those of you participating via conference call, slides are made available via webcast and can also be accessed via the investor relations page of our website following the conclusion of today's call. Before we begin, let me remind you that during the course of this conference call, the company will make forward-looking statements.

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，也可以在今天的電話會議結束後透過我們網站的投資者關係頁面存取幻燈片。在我們開始之前，請允許我提醒您，在本次電話會議期間，本公司將做出前瞻性陳述。

We caution you that any statement that is not a statement of historical fact is a forward-looking statement. 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.

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。這包括有關公司的預測、期望、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 judgement 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 in this conference call and webcast are described in the Safe Harbor statement in today's press release and inherence public periodic filings with the SEC.

今天的新聞稿中的安全港聲明以及向美國證券交易委員會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的前瞻性陳述相關的風險和不確定性。

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.

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 it over to Craig Collard, Chief Executive Officer of Heron.

現在，我想將其交給 Heron 執行長 Craig Collard。

Thanks Melissa. Good morning, everyone, and welcome to the Heron Therapeutics second quarter 2024 earnings call. Today, we are pleased to update you on our latest achievements for the second quarter, which includes a narrowing of our financial guidance and a view into our financial performance, discussion of our product performance, progression of the Vial Access Needle or VAN towards our September 23 PDUFA date, the publishing of the long awaited NOPAIN Act, which includes ZYNRELEF and last, an update on the building and training of our partners at CrossLink.

謝謝梅麗莎。大家早安，歡迎參加 Heron Therapeutics 2024 年第二季財報電話會議。今天，我們很高興向您介紹我們第二季度的最新成就，其中包括縮小我們的財務指導範圍和對我們財務業績的看法、對我們產品性能的討論、小瓶接入針或 VAN 向 9 月份的進展2019 年PDUFA 日期23 日，期待已久的NOPAIN 法案發布，其中包括ZYNRELEF，最後是有關CrossLink 合作夥伴建設和培訓的最新資訊。

Now moving to financial performance. I believe this slide illustrates the impact our new management team has had on this business as we compare first half of 2024 for the first half of 2023. Keep in mind the management team was not fully in place until August of 2023.

現在轉向財務績效。我相信這張投影片說明了我們的新管理團隊對這項業務的影響，因為我們將 2024 年上半年與 2023 年上半年進行了比較。請記住，管理團隊直到 2023 年 8 月才完全到位。

Since arriving, we have been able to establish the proper financial management that has allowed us to reduce spends dramatically while still growing top line revenue. As you can see from the slide, revenues were up 15%. Gross margin has improved from 40% to 73%, and operating expenses have been reduced by over $36 million when comparing the first six months of 2024, the same period in 2023.

自抵達以來，我們已經能夠建立適當的財務管理，使我們能夠大幅減少支出，同時仍增加營收。正如您從幻燈片中看到的，收入增長了 15%。與 2024 年前六個月和 2023 年同期相比，毛利率從 40% 提高到 73%，營運費用減少了超過 3,600 萬美元。

Now moving to product performance. The oncology franchise continues to outpace our expectations with CINVANTI net revenues of $24.9 million for the quarter, and SUSTOL net revenues of $4.3 million for the quarter.

現在轉向產品性能。腫瘤專營業務持續超出我們的預期，CINVANTI 本季淨收入為 2,490 萬美元，SUSTOL 本季淨收入為 430 萬美元。

We continue to maintain our existing market share in a very competitive environment with the oncology franchise, and we believe these products will continue to show similar consistency throughout 2024. Total acute care net revenues for the quarter were $6.8 million, which is record revenue for our acute business. ZYNRELEF net revenues for the quarter were $5.8 million. APONVIE net revenues for the quarter were $1 million, which is double versus Q1 of this year.

我們在腫瘤特許經營權競爭非常激烈的環境中繼續保持現有的市場份額，我們相信這些產品將在 2024 年繼續表現出類似的一致性。本季急診淨收入總額為 680 萬美元，創下了我們急診業務的創紀錄收入。ZYNRELEF 本季淨收入為 580 萬美元。APONVIE 該季度的淨收入為 100 萬美元，是今年第一季的兩倍。

While we are pleased with the direction we are headed, we realize we are still transitioning with our new expanded ZYNRELEF label, bringing on the CrossLink team, the VAN submission, and launch later this year, which will all have a dramatic impact to not only ZYNRELEF as we move later in the year and into 2025, but also APONVIE that these actions will free up more selling time for our sales team and allow us to create better pull-through with our account wins.

雖然我們對前進的方向感到滿意，但我們意識到我們仍在與新擴展的 ZYNRELEF 標籤進行過渡，引入 CrossLink 團隊、VAN 提交並在今年晚些時候推出，這不僅會產生巨大影響ZYNRELEF 隨著我們在今年稍後進入2025 年，但APONVIE 也表示，這些行動將為我們的銷售團隊騰出更多銷售時間，並使我們能夠更好地贏得客戶。

As we think about APONVIE performance, it's important to know that APONVIE is the type of product where systematic wins are possible. What I mean specifically is when we win at the P&T and formulary level, protocols can be put in place where APONVIE is used through our hospital system for a specific patient or surgery type.

當我們考慮 APONVIE 的性能時，重要的是要知道 APONVIE 是一種可以實現系統性勝利的產品類型。我的具體意思是，當我們在 P&T 和處方層面獲勝時，就可以製定協議，透過我們的醫院系統針對特定患者或手術類型使用 APONVIE。

As you can see on this slide, we continue to gain P&T wins and new customers ordering. The goal with any new account win is to establish a protocol, get product already set up in a hospital system and then move to expand usage within the hospital.

正如您在這張幻燈片中看到的，我們繼續獲得 P&T 勝利和新客戶訂購。任何新帳戶獲勝的目標都是建立一個協議，讓產品已經在醫院系統中設置，然後擴大醫院內的使用範圍。

Slide 10 provides a dashboard of how we forecast our APONVIE business. We've established sharing by account size based on the number of surgical procedures within each account. Commercially this allows us to better focus our sales team, and evaluate account performance within each tier.

幻燈片 10 提供了我們如何預測 APONVIE 業務的儀表板。我們根據每個帳戶內的外科手術數量建立了按帳戶規模的共享。從商業角度來看，這使我們能夠更好地集中我們的銷售團隊，並評估每個層級的客戶績效。

We believe the greatest opportunity resides in the surgical patients that presents the operating room with moderate and high risk of having postoperative nausea and vomiting. This risk evaluation already happens pre-operatively across the country and use a validated series of questions to reliably classify these patients.

我們相信最大的機會在於手術患者，他們在手術室中出現術後噁心嘔吐的中度和高度風險。這種風險評估已經在全國範圍內進行術前進行，並使用一系列經過驗證的問題對這些患者進行可靠的分類。

The medical literature informs us that approximately 1 in 2 patients or 50% present as moderate to high risk. Our internal sales target is to achieve market penetration of 40% of that 50% of high risk patients or if you will, 20% of the overall surgical opportunity with our converted business.

醫學文獻告訴我們，大約二分之一或 50% 的患者有中度至高風險。我們的內部銷售目標是透過我們轉型後的業務實現 50% 高風險患者的 40% 的市場滲透率，或者如果您願意的話，實現整體手術機會的 20%。

The opportunity we have today reflects a $30 million potential from the 320 accounts currently under contract. Our confidence of APONVIE is based on the ease of use, the superior onset of action via intravenous administration, the absence of infusion reactions as well as the absence of certain central nervous system and cardiovascular side effects, seen with other agents.

我們今天擁有的機會反映了目前簽訂合約的 320 個帳戶的 3000 萬美元潛力。我們對 APONVIE 的信心是基於它的易用性、透過靜脈注射起效的優越性、不存在輸液反應以及不存在某些中樞神經系統和心血管副作用（與其他藥物一樣）。

We believe there's an opportunity to convert business with the use of APONVIE when other approaches to preventing APONVIE still report an approximate 30% failure rate in this high risk population.

我們相信，當其他預防 APONVIE 的方法仍報告在這一高風險族群中的失敗率約為 30% 時，使用 APONVIE 就有機會實現業務轉型。

Of course, slide 10 only takes into account the business Heron has today. There are an estimated 75 million surgical procedures in the US every year. While penetrating 20% of the entire market may not be achievable, Heron does believe that as we convert more accounts that APONVIE is our (inaudible)

當然，幻燈片 10 僅考慮了 Heron 目前的業務。據估計，美國每年進行 7,500 萬例外科手術。雖然滲透整個市場的 20% 可能無法實現，但 Heron 確實相信，隨著我們轉換的帳戶越來越多，APONVIE 就會成為我們的目標。（聽不清楚）

Moving to ZYNRELEF, it's important to note the progress and the number of improvements of the product that we have coming in 2024. In January, it started off with a much anticipated label expansion, which now allows ZYNRELEF to be used much more broadly throughout the number of surgeries within a given hospital or ASC.

轉向 ZYNRELEF，重要的是要注意我們 2024 年推出的產品的進展和改進數量。一月份，它開始了備受期待的標籤擴展，現在 ZYNRELEF 可以在特定醫院或 ASC 內的手術數量中更廣泛地使用。

Second is the introduction of the VAN, which if approved in September, will go live in Q4. Next is the inclusion of ZYNRELEF in the much anticipated NOPAIN Act, which will continue to allow ZYNRELEF to be reimbursed outside of surgical bundle. And last, the CrossLink partnership, which continues to progress.

其次是 VAN 的推出，如果 9 月獲得批准，將在第四季上線。接下來是將 ZYNRELEF 納入備受期待的 NOPAIN 法案，該法案將繼續允許 ZYNRELEF 在手術捆綁之外得到報銷。最後，CrossLink 合作夥伴關係仍在不斷取得進展。

Now understanding the impact of VAN is a bit easier, when you see both devices to pick it together. Our current configuration with the VVS or vented vial spike on the left hand side of the slide is a much more difficult to use as compared to the VAN or Vial Access Needle on the right hand side of the slide.

現在，當您看到兩種設備一起選擇 VAN 時，理解 VAN 的影響就更容易了。與載玻片右側的 VAN 或小瓶存取針相比，我們目前在載玻片左側使用 VVS 或通氣瓶針的配置要困難得多。

The two main advantages that the VAN offers is the sterility and speed of product withdrawal from the vial. The preparation of ZYNRELEF has been at (inaudible) since launch. We believe the launch of the VAN later this year combined with the expanded label and having a CrossLink presence within the OR study is going to provide a tremendous boost to ZYNRELEF for years to come.

VAN 的兩個主要優點是無菌和產品從小瓶中取出的速度。自推出以來，ZYNRELEF 的準備工作一直在（聽不清楚）。我們相信，今年稍後推出的 VAN 加上擴展的標籤以及在 OR 研究中的 CrossLink 存在將為 ZYNRELEF 在未來幾年提供巨大的推動力。

Now moving to NOPAIN Act. CMS recently released its Outpatient Prospective Payment System, OPPS, and Ambulatory Surgical Center, ASC, proposed rule, for calendar year 2025. The rule included the non-opioid policy for pain relief, which was supported by the NOPAIN Act.

現在轉向 NOPAIN 法案。CMS 最近發布了 2025 日曆年的門診預期支付系統 (OPPS) 和門診手術中心 (ASC) 擬議規則。該規則包括用於緩解疼痛的非鴉片類藥物政策，並得到《NOPAIN 法案》的支持。

As expected, ZYNRELEF was the main product in the rule. This will benefit Heron and our patients on multiple levels. The inclusion of ZYNRELEF in the rule will increase awareness, remove financial barriers, encourage adoption, and endorses its use.

正如預期的那樣，ZYNRELEF 是該規則中的主要產品。這將使 Heron 和我們的患者在多個層面上受益。將 ZYNRELEF 納入規則將提高意識、消除財務障礙、鼓勵採用並認可其使用。

The acronym NOPAIN stands for Non-Opioids Prevent Addiction in the Nation, which in itself is a strong endorsement. The goal of the act was to ensure patients have access to non-opioid alternatives and providers are not financially incentivized to utilize opioids instead.

首字母縮略詞 NOPAIN 代表“國家非阿片類藥物預防成癮”，這本身就是一個強有力的認可。該法案的目標是確保患者能夠獲得非阿片類藥物替代品，並且提供者不會在經濟上受到激勵而使用鴉片類藥物。

To be included, the medications must have an indication for postoperative pain, not act upon the bodies opioid receptors and have proven efficacy in the ability to replace, reduce, or avoid intraoperative and postoperative opioid use.

要納入其中，這些藥物必須具有術後疼痛的適應症，不作用於體內的阿片受體，並且已證明能夠有效替代、減少或避免術中和術後阿片類藥物的使用。

CMS agreed that ZYNRELEF's clinical attributes satisfy these requirements. CMS proposed to include ZYNRELEF in the policy for calendar year 2025, effective April 1, 2025, which will ensure ZYNRELEF is eligible for separate payment outside the surgical bundle.

CMS 認為 ZYNRELEF 的臨床屬性符合這些要求。CMS 提議將 ZYNRELEF 納入 2025 日曆年的保單，並於 2025 年 4 月 1 日生效，這將確保 ZYNRELEF 有資格在手術套餐之外單獨付款。

We believe based on the CMS action and the endorsement of non-opioid therapies that many more commercial payers could also follow suit. Overall, we were extremely pleased with the proposed rule, and this will ultimately support increased adoption of ZYNRELEF.

我們相信，基於 CMS 行動和非阿片類藥物療法的認可，更多商業付款人也可以效仿。總體而言，我們對擬議的規則非常滿意，這最終將支持 ZYNRELEF 的更多採用。

Training with the CrossLink team kicked off with the executive team in late February and with the rest at the beginning of March. As of today, we have 561 CrossLink reps consisting of joint, trauma, and spine that have been fully trained and are in the field selling ZYNRELEF in 28 states.

CrossLink 團隊的培訓於 2 月底與執行團隊一起開始，其餘人員則在 3 月初開始。截至今天，我們有 561 名 CrossLink 代表，包括關節、創傷和脊椎領域的代表，他們都接受過全面培訓，在 28 個州現場銷售 ZYNRELEF。

Now obviously all of these new sales folks were not in the field in Q2, and while we are pleased with our progress, there is a learning curve that's part of this process. As an example, once a new CrossLink group comes out of training, the process begins for our sales teams to interact, to determine physician and account targeting, IDN formulary strategy, product messaging to a given account, and ultimately a planned attack within a territory.

現在顯然所有這些新銷售人員在第二季度都不在現場，雖然我們對我們的進展感到滿意，但這個過程中有一個學習曲線。舉例來說，一旦新的CrossLink 小組完成培訓，我們的銷售團隊就開始進行互動，以確定醫生和帳戶目標、IDN 處方策略、向給定帳戶發送產品訊息，以及最終在某個地區內計劃進行的攻擊。

Our plan is still continuing to expand our reach across the country with over 650 reps being fully trained and integrated before the launch of the VAN in Q4 this year. We continue to be impressed by the CrossLink team and the relationships they have with the orthopedic surgical community, and we realized at the time this is going to have a substantial impact on ZYNRELEF revenues.

我們的計劃仍在繼續擴大我們在全國的覆蓋範圍，在今年第四季度推出 VAN 之前，將有超過 650 名代表接受全面培訓和整合。CrossLink 團隊以及他們與骨科手術界的關係仍然給我們留下了深刻的印象，我們當時意識到這將對 ZYNRELEF 收入產生重大影響。

In Q2 alone, we have over 350 new surgeon introductions, generating 98 new prescribing physicians that translates to 33 new ordering accounts. It's obvious this has not had a major impact on revenues yet, but we believe the impact will be substantial over time. Many of these new introductions are with top prescribing physicians with deep relationships with CrossLink.

光是第二季度，我們就引進了超過 350 名新外科醫生，產生了 98 名新處方醫生，相當於 33 個新訂購帳戶。顯然這尚未對收入產生重大影響，但我們相信隨著時間的推移，影響將是巨大的。其中許多新介紹都是由與 CrossLink 有著深厚關係的頂級處方醫生推出的。

As with any new drug, it takes some time for physicians to get comfortable with something new or different, especially due to the unique delivery and application of ZYNRELEF. We are extremely pleased with the progress we've made in getting the CrossLink team trained and in the field. We believe this partnership is going to completely change the direction of ZYNRELEF as we move into 2025 and beyond.

與任何新藥一樣，醫生需要一些時間來適應新的或不同的藥物，特別是由於 ZYNRELEF 獨特的給藥和應用。我們對 CrossLink 團隊在培訓和現場工作方面的進展感到非常滿意。我們相信，隨著我們進入 2025 年及以後，這種合作關係將徹底改變 ZYNRELEF 的方向。

I will now turn the call over to Ira Duarte, our CFO to cover our financials and update our financial guidance. Go ahead Ira.

我現在將把電話轉給我們的財務長 Ira Duarte，負責介紹我們的財務狀況並更新我們的財務指導。艾拉，繼續吧。

Thanks Craig. Craig has covered our past performance and operating results in his comments, and I will add some additional points for our Q2 2024 results. Our product gross profit for the three months ended June 30, 2024, was $25.5 million or 71% which increased from 37% for the same period in 2023. This was primarily due to the fact that the current quarter did not see the significant inventory write-offs we experienced in the comparable quarter of 2023.

謝謝克雷格。克雷格在他的評論中介紹了我們過去的業績和經營業績，我將為我們 2024 年第二季的業績添加一些額外的要點。截至 2024 年 6 月 30 日止三個月，我們的產品毛利為 2,550 萬美元，或 71%，高於 2023 年同期的 37%。這主要是因為本季沒有出現 2023 年同期的重大庫存沖銷。

Year-to-date, our product gross profit was $51.7 million or 73%, an increase from 40% for the same period in 2023. SG&A expenses for the three and six months ended June 30, 2024, were $27.5 million and $53.9 million, respectively, compared to $40.8 million and $77.8 million respectively in the same period in 2023. The decrease was primarily related to a decreases in personnel and related costs due to the reductions in (inaudible) the prior years as well as improved cost efficiencies along all departments.

年初至今，我們的產品毛利為 5,170 萬美元，即 73%，較 2023 年同期的 40% 有所成長。截至 2024 年 6 月 30 日的三個月和六個月的銷售、一般管理費用分別為 2,750 萬美元和 5,390 萬美元，而 2023 年同期分別為 4,080 萬美元和 7,780 萬美元。減少的主要原因是前幾年（聽不清楚）的減少以及所有部門成本效率的提高導致人員和相關成本的減少。

Research and development expenses were $4.4 million and $9 million for the three and six months ended June 30, 2024, compared to $13.2 million and $22 million in the comparable period in 2023. The decrease was primarily related to decreases in personnel and related costs due to the reductions in (inaudible) implemented in previous years as well as decreases in development activities.

截至2024年6月30日的三個月和六個月，研發費用分別為440萬美元和900萬美元，而2023年同期的研發費用為1,320萬美元和2,200萬美元。減少的主要原因是前幾年實施的（聽不清楚）減少以及開發活動的減少導致人員和相關成本的減少。

During the quarter, we incurred inventory write-offs of $1.6 million, but unlike last year's write-off, these were not related to inventory management. In addition, we also reported asset payment write-off of $1.3 million related to projects no longer part of the company's forward-looking strategy.

本季度，我們發生了 160 萬美元的庫存沖銷，但與去年的沖銷不同，這些與庫存管理無關。此外，我們也報告了與不再屬於公司前瞻性策略一部分的項目相關的 130 萬美元資產支付沖銷。

As you will see on the slide, if you exclude depreciation and amortization, stock based compensation, the inventory write-off and the asset impairment write-off, our adjusted operating results would have been positive a $1.7 million operating income, which represents a substantial turnaround in the financial management of our business.

正如您將在幻燈片中看到的那樣，如果排除折舊和攤銷、基於股票的補償、庫存沖銷和資產減值沖銷，我們調整後的經營業績將為正數，達到170 萬美元的營業收入，這代表了可觀的收入。

As noted in the 10-Q, the condensed consolidated statement of operations and comprehensive loss as of June 30, 2023, reflects reclassification of certain expenses from research and development to general and administrative expenses to align with functional expenses incurred. This resulted in no change in total operating expenses.

正如第十季所指出的，截至 2023 年 6 月 30 日的簡明合併營運報表和綜合虧損反映了將某些費用從研發費用重新分類為一般和管理費用，以與發生的職能費用保持一致。這導致總營運費用沒有變化。

The net loss was $9.2 million for the three months ended June 30, 2024, and $12.4 million for the six months ended June 30, 2024, compared to $42.1 million and $74.8 million respectively for the comparable period in 2023. Cash and short term investments at June 30, 2024, was $62.7 million.

截至2024年6月30日止三個月的淨虧損為920萬美元，截至2024年6月30日止六個月的淨虧損為1,240萬美元，而2023年同期淨虧損分別為4,210萬美元及7,480萬美元。截至 2024 年 6 月 30 日，現金和短期投資為 6,270 萬美元。

As you can see from these results, we have made tremendous progress in cutting expenses and creating efficiencies within the company over the last 12 months. We have therefore narrowed our previously given guidance range of $180 million to $160 million for adjusted operating expenses to a range of $107 million to $111 million.

從這些結果可以看出，在過去 12 個月裡，我們在公司內部削減開支和提高效率方面取得了巨大進展。因此，我們將先前給出的調整後營運費用指引範圍從 1.8 億美元至 1.6 億美元縮小至 1.07 億美元至 1.11 億美元。

Adjusted operating expenses exclude stock based compensation, depreciation and amortization, and going forward, we will also exclude impairment of long lived assets and inventory write-offs. We are also narrowing our previously given guidance range for adjusted EBITDA of $22 million loss, $3 million income to a range of $10 million loss to $3 million income. Adjusted EBITDA excludes the stock based compensation, depreciation and amortization, and going forward, we will also exclude impairment of long lived assets and inventory write-offs.

調整後的營運費用不包括以股票為基礎的薪酬、折舊和攤銷，展望未來，我們也將排除長期資產減損和庫存沖銷。我們也將先前給出的調整後 EBITDA 指引範圍從 2,200 萬美元虧損、300 萬美元收入縮小到 1,000 萬美元虧損至 300 萬美元收入。調整後的 EBITDA 不包括基於股票的薪酬、折舊和攤銷，展望未來，我們還將排除長期資產減損和庫存沖銷。

And now we would like to open the call for any questions.

現在我們想打開電話詢問任何問題。

(Operator Instructions) Brandon Folkes, Rodman & Renshaw.

（操作員說明）Brandon Folkes、Rodman 和 Renshaw。

Thanks, and congratulations on a lot of good progress in the quarter. Maybe just firstly for me on ZYNRELEF, any color on where you're seeing the most uptake across joint, trauma, and spine with the CrossLink partnership?

謝謝，並祝賀本季度取得了許多良好進展。也許首先對我來說，在 ZYNRELEF 上，您認為與 CrossLink 合作夥伴關係在關節、創傷和脊椎方面最受關注的地方有什麼顏色？

I'm sorry, Brandon, could you say it one more time?

對不起，布蘭登，你能再說一次嗎？

Any color on where you're seeing the most uptake across joint, trauma, and spine with the CrossLink partnership. Anything new there that you wouldn't have expected?

透過 CrossLink 合作夥伴關係，您在關節、創傷和脊椎上看到最多吸收的地方的任何顏色。有什麼新的東西是你意想不到的嗎？

Yeah, no, at this point again, we've been -- as I said in my comments, we've been getting the CrossLink team up to speed. And in Q2, we had roughly a couple of hundred folks sort of if you will, that had gone through training. And so we haven't been up to really dive into the data enough to tell where we have a large impact.

是的，不，在這一點上，我們一直 - 正如我在評論中所說，我們一直在讓 CrossLink 團隊加快步伐。在第二季度，我們大約有幾百人接受過訓練。因此，我們還沒有真正深入研究數據來判斷我們在哪些方面產生了巨大的影響。

I mean, obviously, with orthopedic surgeons is where we spend a majority of time but at this point, I just can't really dice the data into that sort of level in order to determine specifically or have an impact in one place more than another.

我的意思是，顯然，我們大部分時間都花在整形外科醫生身上，但在這一點上，我無法真正將數據劃分為那種級別，以便具體確定或在一個地方比另一個地方產生更大的影響。

Okay. And then maybe just you obviously did a tremendous job during the quarter on the rep training with CrossLink. Can you just elaborate when you expect to see that revenue trajectory change with ZYNRELEF? And do you have to retrain the CrossLink team when the VAN comes out to market or how thorough does that training need to be?

好的。然後，也許只有您在本季透過 CrossLink 進行代表培訓方面顯然做得非常出色。您能否詳細說明您預期 ZYNRELEF 帶來的營收軌跡會發生什麼變化？當 VAN 上市時，您是否需要重新培訓 CrossLink 團隊？

Yes. So we have been a long way ago talking about the VAN and they know that certainly is coming and I think it was obviously anticipated. We do anticipate being fully trained by the time the VAN launches. And again, so we think that's also going to have an impact, but there will be a certainly a briefing post the approval of exactly what we get approved and then also the timing to launch and all that. So we'll go through that again with them, but they are being briefed on sort of what's going on, what's coming.

是的。因此，我們很久以前就在談論 VAN，他們知道這肯定會到來，我認為這顯然是可以預料的。我們確實預計在 VAN 推出時能夠接受全面的培訓。再說一次，我們認為這也會產生影響，但肯定會有一個簡報，批准我們所批准的具體內容，然後還有啟動的時間等等。因此，我們將與他們再次討論這個問題，但我們將向他們通報正在發生的事情和即將發生的事情。

Great. Thanks so much. Great to know all that progress. Maybe just last one for me. On the gross margin line, obviously tremendous progress year over year. How should we look at this quarter compared to the go forward? And then that's it for me. Thank you.

偉大的。非常感謝。很高興知道所有這些進展。也許對我來說只是最後一張。在毛利率線上，年比明顯進步巨大。與未來相比，我們該如何看待本季？然後我就這樣了。謝謝。

At this point, again, we've said all along, we think we'll be somewhere in the kind of low to mid 70s, we anticipate that continuing, again, with product mix and so forth, it may vary a little bit, but we should be in that range.

在這一點上，我們一直說過，我們認為我們將處於 70 年代中低水平，我們預計，隨著產品組合等的繼續，它可能會略有不同，但我們應該在這個範圍內。

Great. Thank you very much.

偉大的。非常感謝。

Thanks, Brad.

謝謝，布拉德。

Serge Belanger, Needham.

塞爾吉·貝蘭格，李約瑟。

Hey, good afternoon and thanks for taking my question. The first one, Craig, on ZYNRELEF, can you just give us a picture of what the current reimbursement and coverage is across the Medicare and commercial segments and how you think that will change once you switch over to NOPAIN next year?

嘿，下午好，感謝您提出我的問題。第一個是 ZYNRELEF 上的 Craig，您能否向我們介紹一下醫療保險和商業領域當前的報銷和承保範圍，以及您認為明年轉用 NOPAIN 後情況會如何變化？

And then secondly, on CINVANTI, I think a dense trial was held last month or June -- late June in the patent infringement lawsuit. Can you just give us an update on when you expect the decision, what the potential outcomes could be and things like that?

其次，在 CINVANTI 上，我認為上個月或六月——六月底的專利侵權訴訟中進行了一次密集的審判。您能否向我們介紹一下您預計何時做出決定、潛在結果是什麼以及諸如此類的最新情況？

Yeah, sure. Actually Serge, Kevin Warner is on call as well, I let him get the first part of this, and then I'll address the CINVANTI piece.

是的，當然。事實上，Serge、Kevin Warner 也在隨叫隨到，我讓他先講了第一部分，然後我會講 CINVANTI 的部分。

Yeah, thanks Serge. In regards to the reimbursement picture and how it looks, there's a difference between NOPAIN and a pass-through status product. So currently right now, ZYNRELEF reimbursed be the pass-through status. And so that's all our hospital outpatient procedure department patients and all of our ASC patients under Medicare reimbursed.

是的，謝謝塞爾吉。從報銷圖片和外觀來看，NOPAIN 和直通狀態產品之間存在差異。所以目前，ZYNRELEF 以傳遞狀態進行報銷。這就是我們醫院門診手術部的所有患者以及 Medicare 報銷的所有 ASC 患者。

As far as the commercial payers, somewhere between 30% and 50% of the commercial payers, it varies by state by state region by region. That said, with NOPAIN that paradigm kind of switches because the NOPAIN is phrased, and historically that commercial payers don't come on and always follow these pass-through drug stipulations.

就商業付款人而言，約佔商業付款人的 30% 到 50%，具體情況因州、地區而異。也就是說，隨著 NOPAIN 的出現，這種範式發生了轉變，因為 NOPAIN 是有措辭的，而且從歷史上看，商業付款人不會出現並始終遵循這些轉手藥物規定。

But with NOPAIN and the fact that it has clinical attributes and the reasoning for using non-opioids and minimizing the impact of opioids in our nation, there's more, I guess, a push for them to follow along with the statute -- the fact that it could be extended in perpetuity and continue to provide that reimbursement.

但是，有了NOPAIN 以及它具有臨床屬性以及使用非阿片類藥物並最大限度地減少阿片類藥物對我們國家的影響的理由這一事實，我想，還有更多的動力促使他們遵守法規——事實是它可以永久延長並繼續提供補償。

So the commercial payers, a few other, they're going to want to be on the right side of the fence on this paradigm. They understand the cost efficacies and the clinical efficacies, the overall economic model. So we expect to see more commercial payers come on board with NOPAIN and NOPAIN really doesn't change the current reimbursement from the CMS perspective.

因此，商業付款人，以及其他一些人，他們將希望在這種範式上站在正確的一邊。他們了解成本效益和臨床療效以及整體經濟模型。因此，我們預計會看到更多的商業付款人加入 NOPAIN，並且從 CMS 的角度來看，NOPAIN 確實不會改變目前的報銷。

Great.

偉大的。

As you stated, the trial ended in June. And again, as we've said all along, we feel very comfortable with what happened in the trial, we feel very strong in our positioning. And again, this change really comes down to we have -- infringement has sort of been established in the case and it all really comes down to obviousness.

正如你所說，審判於六月結束。再說一遍，正如我們一直以來所說的那樣，我們對試驗中發生的事情感到非常滿意，我們對自己的定位感到非常堅定。再說一遍，這項變更實際上取決於我們——該案中已經確立了侵權行為，這一切都歸結為顯而易見的。

Again, that's where we feel the invention that we made here was unique. Merck had this product for years as a product set and was unable to get this in this form. And so that really is what this comes down to the burden of proof there. And again, we feel that (inaudible) did not meet that, and we feel very comfortable with our position.

同樣，這就是我們覺得我們在這裡所做的發明是獨一無二的地方。默克公司多年來一直將該產品作為產品組合，但無法以這種形式獲得。所以這確實是歸結為舉證責任的問題。再說一遍，我們覺得（聽不清楚）沒有滿足這項要求，我們對自己的立場感到非常滿意。

And do expect the court decision, I think the current 24th, -- the 30 month (inaudible) expire in December. Is that when you think you will get a court decision?

我認為目前的 24 日是法庭判決，30 個月（聽不清楚）將於 12 月到期。您認為那時您會得到法庭判決嗎？

Yeah. So, there's -- yeah, remaining to be done are closing arguments and then we're expecting a decision to be made in Q4 this year.

是的。所以，是的，剩下的工作是結案陳詞，然後我們預計在今年第四季做出決定。

Got it, thank you.

明白了，謝謝。

Okay.

好的。

Kelly Shi, Jefferies.

施凱莉，傑弗里斯。

Hi, this is [Clara] on for Kelly. Thanks for taking our question. So could you remind us how many CrossLink reps are in the field selling product during second quarter and how that number is going to change in the second half of 2024?

大家好，我是凱莉的[克拉拉]。感謝您提出我們的問題。那麼您能否提醒我們第二季有多少 CrossLink 代表在現場銷售產品以及該數字在 2024 年下半年將如何變化？

And based on the experience they have in the field so far, I was wondering if you've heard any feedback and you know, if there's anything you think were could be added to their training for the remaining reps or maybe also the existing reps that will be helpful in selling that product? Thank you.

根據他們迄今為止在該領域的經驗，我想知道您是否聽到任何反饋，並且您知道，是否有任何您認為可以添加到他們對剩餘代表或現有代表的培訓中對銷售該產品有幫助嗎？謝謝。

(technical difficulty) CrossLink which were North Carolina, top line in Georgia, and then we moved from there. But we end up getting I think by Q2, we had a couple of hundred reps and we had just migrated to maybe 12 states.

（技術難度）CrossLink 是北卡羅來納州，喬治亞州的頂線，然後我們從那裡搬家。但我認為到第二季度，我們最終得到了幾百名代表，而且我們剛剛遷移到了大約 12 個州。

And so, where we sit now is 561 reps in 28 states, and that continues to grow. And again, we believe we'll be over 650 at the time of launch with the VAN. And so if you think about sort of inflection and how this really comes together, we've had a lot of things happen this year, obviously with NOPAIN Act, the expansion of our label, getting the CrossLink folks trained.

因此，我們現在在 28 個州擁有 561 名代表，而且這一數字還在繼續增長。再次強調，我們相信 VAN 推出時我們的人數將超過 650 人。因此，如果你考慮一下這種變化以及它是如何真正結合在一起的，你會發現今年我們發生了很多事情，顯然是 NOPAIN Act、我們品牌的擴張、對 CrossLink 人員的培訓。

And but there's other piece of this too, which is really the integration with our sales force and managing that and working together, targeted accounts and all that. So that just takes time. So I've said all along that we view that as we launched the VAN and really kind of move out of Q4 into Q1 of '25, it's really when we see the majority of inflection taking place into next year. And so this just takes time in order to get all this sort of fully up to speed and integrated.

但還有其他部分，這實際上是與我們的銷售團隊的整合、管理、合作、目標客戶等等。所以這只是需要時間。因此，我一直在說，我們認為，當我們推出 VAN 並真正從 25 年第四季進入第一季時，我們實際上會看到大部分轉折點發生在明年。因此，這只是需要時間才能讓所有這些完全加快速度並進行整合。

Thank you.

謝謝。

Okay, thank you.

好的，謝謝。

(Operator Instructions) Carl Byrnes, Northland Capital Markets.

（操作員說明）Carl Byrnes，北國資本市場。

Thanks for the question and congratulations on your progress. In the event that we see a generic Exparel down the road, how do you see that changing the dynamics, if at all, for ZYNRELEF? Thanks. And I have a follow-up as well.

感謝您的提問並祝賀您的進步。如果我們看到通用的 Exparel 即將上市，您如何看待 ZYNRELEF 的動態變化（如果有的話）？謝謝。我也有後續行動。

Hey Carl, it's Kevin Warner, I'll jump in and take that one, appreciate that. I guess the question is if we see a generic and then if at all, how would it impact ZYNRELEF? There's multiple barriers here to the access to the market with them, the current brand of manufacturer has multiple patents that they feel confident in.

嘿卡爾，我是凱文華納，我會跳進去接受那個，謝謝。我想問題是，如果我們看到仿製藥，那麼如果有的話，它會對 ZYNRELEF 產生什麼影響？他們進入市場存在多重障礙，目前的製造商品牌擁有多項他們感到有信心的專利。

Maybe we have yet to receive a sample or if it's known one of the generic manufacturer would be able to scale, if you will, as they've always cited that as being very challenging. But that said, a generic product, if it did come to market, the second major barrier will be the possible lack of financial benefit.

也許我們還沒有收到樣品，或者如果已知的話，通用製造商之一將能夠擴大規模，如果你願意的話，因為他們總是認為這是非常具有挑戰性的。但話雖如此，仿製藥如果真的上市，第二個主要障礙將是可能缺乏經濟利益。

So historically, most generics come to market obviously as a discount to the branded product to provide financial advantage to our healthcare system. But in today's current economic climate, specifically with the NOPAIN Act and broadening commercial reimbursement, those advantages would be mute, if you will.

因此，從歷史上看，大多數仿製藥進入市場顯然是作為品牌產品的折扣，為我們的醫療保健系統提供財務優勢。但在當今的經濟環境下，特別是在《NOPAIN 法案》和擴大商業報銷範圍的情況下，如果你願意的話，這些優勢將變得微不足道。

So ZYNRELEF or even Exparel to that extent with the reimbursement package from NOPAIN the follow-on commercials could trump with utilizing a genericized product. When looking at the possibility of more non-opioid analgesics just in general come to market, I see synergies rather than antagonism.

因此，ZYNRELEF 甚至 Exparel 憑藉 NOPAIN 的報銷方案，後續廣告可能會勝過使用通用產品。當考慮更多非鴉片類鎮痛藥進入市場的可能性時，我看到的是協同作用而不是拮抗作用。

With the practice of medicine moving to opioid sparing therapies, novel mechanisms are needed in order to provide the most effective multimodal therapy. So whether it's generic liposome bupivacaine as a regional block or an oral NaV1.8 inhibitor like Vertex's Suzetrigine.

隨著醫學實踐轉向阿片類藥物節約療法，需要新的機制來提供最有效的多模式治療。因此，無論是作為區域阻斷劑的通用脂質體布比卡因，或是 Vertex 的 Suzetrigine 等口服 NaV1.8 抑制劑。

I see opportunities for ZYNRELEF as the best-in-class local installation product to be combined with the other modalities as we all seek one common goal, right, and that's to minimize or eliminate the need for opioids.

我認為 ZYNRELEF 作為一流的本地安裝產品有機會與其他方式相結合，因為我們都在尋求一個共同的目標，對吧，那就是最大限度地減少或消除對阿片類藥物的需求。

Looking at a fundamental level though, just briefly considering liposomal bupivacaine as a competitor or not, you have to look at the key differences of what makes a drug a drug, right, if you will, so the active ingredients, the dose, the route, the frequency, the mechanism of action, in the end, the primary prescribers.

但從基本層面來看，只要簡單地考慮一下脂質體布比卡因是否是競爭對手，你就必須看看藥物成為藥物的關鍵區別，對吧，如果你願意的話，那麼活性成分、劑量、途徑、頻率、作用機制，最後是主要處方者。

So these all differ between ZYNRELEF and liposomal bupivacaine. They're different drugs. One is a combo, one is a single agent. The dose is different, up to 400 milligrams of bupivacaine ZYNRELEF, 266 milligrams of liposomal bupivacaine. ZYNRELEF extended release, liposomal is not. Route of administration is installation for ZYNRELEF, injection for liposomal bupivacaine. Also the site of action, whether it's local or regional.

因此，ZYNRELEF 和脂質體布比卡因之間都有所不同。它們是不同的藥物。一種是組合，一種是單一代理。劑量不同，布比卡因ZYNRELEF最多400毫克，脂質體布比卡因266毫克。ZYNRELEF 緩釋劑，脂質體則不是。給藥途徑為安裝ZYNRELEF，注射脂質體布比卡因。也是行動地點，無論是本地的還是區域的。

And then, possibly most importantly, who is your prescriber, if you will. So for ZYNRELEF, it's the surgeon doing the installation process and largely with liposomal now, it's mainly the anesthesiologist doing regional blockades with it.

然後，可能最重要的是，如果您願意的話，誰是您的處方醫生。因此，對於 ZYNRELEF 來說，是外科醫生進行安裝過程，現在主要使用脂質體，主要是麻醉師用它進行區域封鎖。

So huge differences overall, when looking at, is it truly a comparator when you look at those fundamentals. And in the end, the last piece I'd mentioned is the clinical efficacy, right, ZYNRELEF has proven through 72 hours over standard of care for pain reduction, severe pain reduction, and opioid reduction across multiple clinical trials, but also real world trials even head-to-head against liposomal showing benefit. So it makes those decisions fairly simple for our institutions.

總體而言，巨大的差異，當你審視這些基本面時，它真的是一個比較器嗎？最後，我提到的最後一點是臨床療效，對吧，ZYNRELEF 已在多項臨床試驗和真實世界試驗中證明了超過 72 小時的標準護理可減輕疼痛、減輕嚴重疼痛和減少阿片類藥物甚至與脂質體正面交鋒也顯示出優勢。因此，對於我們的機構來說，這些決策變得相當簡單。

Great. Thanks Kevin, very helpful. On a different topic, what are you seeing with respect to opportunities for potential complementary tuck-in acquisitions and what sort of timing might we expect in terms of some activity there? Thanks.

偉大的。謝謝凱文，非常有幫助。在另一個主題上，您對潛在的補充性收購機會有何看法，以及我們預計在那裡進行某些活動的時機是什麼？謝謝。

You know, Carl, thanks for the great questions. We again, we really tried to put out there certainly in this call and prior calls is really getting our hands around the business and managing it. I think we've shown that we've certainly done that due to reduction of expenses and that type of thing and now it's about growing product and partnership at CrossLink and some of these things.

你知道，卡爾，謝謝你提出的好問題。我們再次嘗試在這次電話會議中明確提出這一點，而先前的電話會議確實讓我們掌握了業務並對其進行管理。我認為我們已經表明，由於費用的減少和類似的事情，我們確實做到了這一點，現在我們的重點是發展 CrossLink 的產品和合作夥伴關係以及其中一些事情。

But really the next phase is what else can we do from an M&A standpoint and again, this management team has been together before, we've done these things, and we're bringing in -- this will be announced in the next few weeks, we're bringing in a business development person to head that up.

但實際上，下一階段是從併購的角度來看我們還能做些什麼，這個管理團隊以前就在一起過，我們已經做了這些事情，而且我們正在引進——這將在接下來的幾週內宣布，我們正在聘請一名業務開發人員來領導這項工作。

And again, we're going to get a lot more -- I guess a lot more active, if you will, in that area looking at things and trying to bring in complementary type of assets and or companies, that would be accretive to what we're doing. And we're going to be fairly active here in a very short timeframe.

再說一次，我們將得到更多——我想如果你願意的話，我們將在該領域更加積極地關注事物並嘗試引入互補類型的資產和/或公司，這將增加我們正在做任何事情。我們將在很短的時間內在這裡相當活躍。

Excellent. Thanks.

出色的。謝謝。

Thanks, Carl. If there are no further questions, just want to thank everybody for being on the call today and we look forward to next quarter's call.

謝謝，卡爾。如果沒有其他問題，我只想感謝大家今天參加電話會議，我們期待下個季度的電話會議。

That will conclude today's call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。