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Operator
Operator
Good afternoon. My name is Brianna, and I will be your conference operator today. At this time, I would like to welcome everyone to the Halozyme second quarter 2024 financial and operating results conference call. (Operator Instructions) Please note this event is being recorded.
午安.我叫布麗安娜,今天我將擔任你們的會議操作員。此時,我歡迎大家參加 Halozyme 2024 年第二季財務與營運業績電話會議。(操作員說明)請注意此事件正在被記錄。
Thank you. I'll now turn the call over to Tram Bui, Halozyme's, Vice President of Investor Relations and Corporate Communications. Please go ahead.
謝謝。現在我將把電話轉給 Halozyme 投資者關係和企業傳播副總裁 Tram Bui。請繼續。
Tram Bui - Vice President - Investor Relations and Corporate Communications
Tram Bui - Vice President - Investor Relations and Corporate Communications
Thank you, operator. Good afternoon, and welcome to our second-quarter 2024 financial and operating results conference call. In addition to the press release issued today, after the market closed, you can find a supplementary slide presentation that will be referenced during today's call in the investor relations section of our website.
謝謝你,接線生。下午好,歡迎參加我們的 2024 年第二季財務與營運業績電話會議。除了今天發布的新聞稿外,收盤後,您還可以在我們網站的投資者關係部分找到將在今天的電話會議期間引用的補充幻燈片演示。
Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business and Nicole LaBrosse, our Chief Financial Officer, will review our financial results as well as our outlook.
Halozyme 總裁兼執行長 Helen Torley 博士將主持此次電話會議,她將介紹我們業務的最新情況,我們的財務長 Nicole LaBrosse 將審查我們的財務業績和前景。
On today's call, we will be making forward-looking statements as outlined on slide 2. I would also refer you to our SEC filings for a full list of risks and uncertainties. During the call, both GAAP and non-GAAP financial measures will be discussed. Certain non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation.
在今天的電話會議上,我們將做出投影片 2 中概述的前瞻性聲明。我還建議您參閱我們向美國證券交易委員會提交的文件,以了解風險和不確定性的完整清單。在電話會議期間,將討論公認會計原則和非公認會計原則財務指標。某些非公認會計原則或調整後的財務指標與我們的收益新聞稿和幻燈片簡報中的可比較公認會計原則財務指標一致。
And I will now turn the call over to Dr. Helen Torley.
我現在將把電話轉給海倫·托利博士。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thank you, Tram, and good afternoon, everyone. Starting on slide 3, I'm pleased to report another robust quarter that is a clear demonstration of the strong execution and continued momentum we have across our business. In the second quarter, we achieved multiple key milestones that support our strong growth projections.
謝謝你,Tram,大家午安。從幻燈片 3 開始,我很高興地報告又一個強勁的季度,這清楚地表明了我們整個業務的強勁執行力和持續勢頭。在第二季度,我們實現了多個關鍵里程碑,支持了我們強勁的成長預測。
During the quarter, we added two and further strengthen our enhanced IP portfolio. In addition, we announced a new partner product approval and a new indication approval for a second partner. And there were multiple additional clinical and regulatory advancement of our exciting pipeline. These achievements support and drive our growth trajectory, mark the expansion of enhance into new treatment areas and reinforced the predictability of the regulatory and commercial success of our enhanced drug delivery technology.
本季度,我們增加了兩個,並進一步加強了我們增強的智慧財產權組合。此外,我們也宣布了新合作夥伴產品的批准以及第二個合作夥伴的新適應症的批准。我們令人興奮的產品線還取得了許多額外的臨床和監管進展。這些成就支持並推動了我們的成長軌跡,標誌著增強型藥物傳輸技術擴展到新的治療領域,並增強了我們增強型藥物傳輸技術的監管和商業成功的可預測性。
As a result of this progress, total revenue in the second quarter grew to $231 million, supporting our full-year growth expectations of 13% to 22%. We delivered $125 million in royalty revenue, an increase of 12% from the prior year and our 16th consecutive quarter of double digit year on year royalty growth. This supports our expectation for royalty growth of 16% to 24% for the full year.
由於這一進展,第二季總營收成長至 2.31 億美元,支持我們 13% 至 22% 的全年成長預期。我們實現了 1.25 億美元的特許權使用費收入,比上年增長 12%,並且連續第 16 個季度實現兩位數的特許權使用費同比增長。這支持了我們對全年特許權使用費成長 16% 至 24% 的預期。
In the second quarter, our high-margin royalty revenue combined with the efficient operations of our business drove EBITDA growth of 19% to $137 million and non-GAAP diluted earnings per share growth of 23% to $0.91. Annual adjusted EBITDA and non-GAAP diluted earnings per share growth will continue to outpace our top line and support 30% to 44% EBITDA growth and 32% to 46% earnings growth year-over-year.
第二季度,我們的高利潤特許權使用費收入與業務的高效營運相結合,推動 EBITDA 成長 19%,達到 1.37 億美元,非 GAAP 攤薄後每股收益成長 23%,達到 0.91 美元。年度調整後 EBITDA 和非 GAAP 稀釋每股收益成長將繼續超過我們的營收成長,並支持 30% 至 44% 的 EBITDA 成長和 32% 至 46% 的獲利年增。
Moving on to slide 4, and I'll provide some more details on our recent progress. Let me start with the most recent success with regard to our IP portfolio, in June, we were granted a new patent for enhanced by the European patent office. The patent expressly claims, the enhanced product that Halozyme provides to its enhanced licensees.
轉到幻燈片 4,我將提供有關我們最近進展的更多詳細資訊。讓我從我們在智慧財產權組合方面最近的成功開始,六月份,我們獲得了歐洲專利局授予的一項新的增強專利。該專利明確聲明了 Halozyme 向其增強型被授權者提供的增強型產品。
Based on this new brand patent coverage in Europe is now extended to March 6, 2029. We have a similar pending reissue patent in the United States which also was granted with the similar scope, will extend patent coverage to March 6, 2029.
基於此新品牌,歐洲的專利覆蓋範圍現已延長至 2029 年 3 月 6 日。我們在美國有一項類似的待批重新頒發專利,該專利也獲得了類似的範圍,將把專利覆蓋範圍延長至 2029 年 3 月 6 日。
Our strong ability to continue to protect our intellectual property portfolio has directly and positively impacted our growth profile. In June, we raised our 5-year outlook based on the new patent and impact to maintain the DARZALEX subcutaneous and amivantamab subcutaneous royalty rate at the original starting royalty rate until March 6, 2029 in Europe.
我們持續保護智慧財產權組合的強大能力對我們的成長狀況產生了直接而正面的影響。6 月,我們根據新專利和影響上調了 5 年展望,以將 DARZALEX 皮下注射和阿米萬他瑪皮下注射使用費維持在原來的起始使用費率,直至 2029 年 3 月 6 日。
Importantly, this results in five additional years of full royalty rates in Europe for DARZALEX subcutaneous. This in turn resulted in an increase in our projected 5-year CAGR for royalty revenue to 20%, an increase in adjusted EBITDA growth to 25% and an increase in non-GAAP diluted earnings per share growth to 23%. We look forward to providing a financial update if the reissued patent, which is pending in the United States, is granted with similar claims to this new European path.
重要的是,這導致 DARZALEX 皮下注射劑在歐洲額外獲得五年的全額特許權使用費。這反過來導致我們預期的特許權使用費收入 5 年複合年增長率提高至 20%,調整後 EBITDA 增長至 25%,非公認會計原則攤薄每股收益增長至 23%。如果美國正在申請的重新頒發專利與這條新的歐洲路徑具有類似的權利要求,我們期待提供財務更新。
I'll move now to slide 5 and review the strong development and regulatory progress that we've made in the quarter, all of which support our robust royalty revenue growth outlook starting with product approvals, we were delighted to announce two new enhanced approvals in the quarter.
我現在將轉到幻燈片5,回顧我們在本季度取得的強勁開發和監管進展,所有這些都支持我們從產品批准開始的強勁特許權使用費收入增長前景,我們很高興宣布兩項新的增強型批准該季度。
These approvals extended enhanced into neurology and expanded our reach in autoimmune diseases, adding to our existing strength in oncology, Roche received EU and UK approval for [Ocrevus] subcutaneous co-formulated with enhanced Octopus subcutaneous allows multiple sclerosis patients in those regions to receive their treatment in just 10 minutes twice a year. For many patients over the subcutaneous will allow patient treatment outside the IV infusion facility, potentially allowing new patients to access this important medicine and also line treatment closer to home.
這些批准擴展到神經病學領域,並擴大了我們在自體免疫疾病領域的影響力,增強了我們在腫瘤學領域的現有實力。獲得了歐盟和英國的批准,使這些地區的多發性硬化症患者能夠接受治療每年兩次只需 10 分鐘的治療。對於許多患者來說,皮下注射將允許患者在靜脈輸液設施之外接受治療,這有可能使新患者能夠獲得這種重要的藥物,並在離家更近的地方進行治療。
Ocrevus subcutaneous represents Halozyme ENHANZE partner products. The second approval was for Agennix is by far head-to-toe, which received FDA approval for the treatment of chronic inflammatory demyelinating polyneuropathy or CIDP, and this marks the second FDA approved indication for the subcutaneous version of five-part within hand.
Ocrevus 皮下注射代表 Halozyme ENHANZE 合作夥伴產品。第二次批准是針對Agenix 的,迄今為止,它已獲得FDA 批准用於治療慢性發炎性脫髓鞘性多發性神經病變或CIDP,這標誌著FDA 批准的第二個皮下版本手內五部分的適應症。
Let's go ahead to the represents the first novel mechanism of action to treat CIDP in 30 years and offers patients a transformational new treatment option with a 30 to 92nd weekly subcutaneous injection.
讓我們繼續討論 30 年來第一個治療 CIDP 的新作用機制,透過每週 30 至 92 次皮下注射為患者提供革命性的新治療選擇。
Moving to regulatory advancements Bristol-Myers Squibb received regulatory filing acceptance for nivolumab subcutaneous in the United States. This allowed us to recognize a $15 million milestone payment in the second quarter for this product. In addition, the nivolumab subcutaneous submission in Europe was accepted by the European Medicines Agency in the quarter, resulting in a $7 million milestone payment to Halozyme.
轉向監管進展 百時美施貴寶 (Bristol-Myers Squibb) 的納武單抗 (nivolumab) 皮下注射在美國獲得監管備案受理。這使我們能夠在第二季為該產品支付 1500 萬美元的里程碑付款。此外,nivolumab 皮下注射在歐洲的提交在本季度被歐洲藥品管理局接受,從而為 Halozyme 支付了 700 萬美元的里程碑付款。
Bristol nivolumab subcutaneous has a producer action date of December 29, 2024. We're also looking forward to potential approvals for Roche's Tecentriq, subcutaneous and Octopus subcutaneous in the United States in September, based on their September 2024, producer action date. We are set up for three new US approvals this year for our Wave 3 product, which adds to the 2023 five got a tool of first approval in generalized myasthenia gravis, and this supports our exciting revenue growth projections.
Bristol nivolumab 皮下注射的生產者行動日期為 2024 年 12 月 29 日。我們也期待羅氏的 Tecentriq、皮下注射和 Octopus 皮下注射劑根據生產商行動日期 2024 年 9 月在 9 月在美國獲得批准。我們的Wave 3 產品今年將在美國獲得3 個新批准,這是繼2023 年獲得首次批准的治療全身性重症肌無力的5 個工具的基礎上增加的一個,這支持了我們令人興奮的收入成長預測。
Another important achievement in the quarter was the result of Johnson & Johnson's Phase 3 PALOMA-3 trial for amivantamab subcutaneous. The PALOMA-3 data was presented at ASCO in May. Notably, the data demonstrated that the subcutaneous delivery of amivantamab with ENHANZE resulted in significant potential benefits for lung cancer patients compared to those receiving IV treatments.
本季的另一個重要成就是強生公司針對阿米萬他布皮下注射的 3 期 PALOMA-3 試驗的結果。PALOMA-3 數據於 5 月在 ASCO 上發布。值得注意的是,數據表明,與接受靜脈注射治療的患者相比,皮下注射阿米萬他單抗與 ENHANZE 可為肺癌患者帶來顯著的潛在益處。
Firstly, treatment time was reduced to less than five minutes compared to five hours for the first infusion of the IV treatment and two hours for subsequent IV treatments.
首先,與首次靜脈注射治療的 5 小時和後續靜脈注射治療的 2 小時相比,治療時間減少到不到 5 分鐘。
Secondly, there was a fivefold reduction in infusion related reactions from 66% with the IV to 13% with the subcutaneous formulation was enhanced. Remember that infusion-related reactions are a potentially serious adverse event that can lead to treatment interruption or even discontinuation.
其次,輸注相關反應減少了五倍,從靜脈注射時的 66% 降至皮下注射製劑增強時的 13%。請記住,輸液相關反應是一種潛在的嚴重不良事件,可能導致治療中斷甚至停止。
And thirdly, an exploratory analysis also showed an intriguing improved overall survival rate for the subcutaneous treated patients. It was reported that 65% of patients receiving subcutaneous were still alive at 12 months compared to 51% who received IV treatment with amivantamab. These compelling results are another clear demonstration of the high predictability of our technology and the benefits it could provide to patients and to health care providers.
第三,一項探索性分析也顯示,皮下治療患者的總存活率得到了令人感興趣的提升。據報道,接受皮下注射治療的患者在 12 個月時仍有 65% 的患者存活,而接受阿米萬他單抗靜脈注射治療的患者這一比例為 51%。這些令人信服的結果再次清楚地證明了我們的技術的高度可預測性以及它可以為患者和醫療保健提供者提供的好處。
Falling in the strong data, Johnson & Johnson announced that we have submitted subcutaneous amivantamab for regulatory approvals in both the United States and in Europe. We were also excited to have acumen dosed their first patient in a Phase 1 study of subcutaneous [sabirnetug], which is a novel therapeutic that targets soluble amyloid beta ligand for the treatment of Alzheimer's disease. We're very pleased to be supporting this opportunity for a more convenient and accessible option using ENHANZE for patients suffering from this challenging disease.
在強勁的數據下,強生宣布我們已向美國和歐洲的監管機構提交皮下注射阿米萬他單抗的批准。我們也很高興 Acumen 在皮下注射 [sabirnetug] 的 1 期研究中給第一位患者註射了藥物,這是一種針對可溶性澱粉樣蛋白 β 配體治療阿茲海默症的新型療法。我們很高興能夠支持這個機會,為患有這種具有挑戰性的疾病的患者提供更方便、更容易使用 ENHANZE 的選擇。
Moving now to slide 6. We remain confident in and are on target to achieve $1 billion in royalty revenue in 2027. This will be driven by the continued strong performance of our Wave 2 products plus the addition of five new royalty revenue streams following approval and launch of all five of our Wave 3 products.
現在轉到投影片 6。我們對 2027 年特許權使用費收入實現 10 億美元仍然充滿信心,並致力於實現這一目標。這將受到我們的 Wave 2 產品持續強勁的表現以及在批准和推出我們的所有五種 Wave 3 產品後增加的五種新的特許權使用費收入來源的推動。
I'll now provide additional details on the second quarter performance, beginning with the continued momentum from our Wave 2 products, DARZALEX FASPRO and [fiscal]. For Johnson & Johnson's DARZALEX sales in the second quarter were $2.9 billion, an increase of 21.3% year over year on an operational basis. It's primarily driven by share gains of 4.6 points across all lines of therapy and continued strong growth in the front-line setting with share gains of 9.4 points.
我現在將提供有關第二季度業績的更多詳細信息,首先是我們的 Wave 2 產品、DARZALEX FASPRO 和[財]。強生公司的 DARZALEX 第二季度銷售額為 29 億美元,按營運計算年增 21.3%。這主要是由所有治療領域的份額增長 4.6 個百分點以及一線治療領域的份額增長持續強勁增長(份額增長 9.4 個百分點)推動的。
Johnson & Johnson also commented that there continues to be market growth. With subcutaneous penetration in excess of 90% in the United States and estimated to exceed 80% outside the United States. DARZALEX FASPRO with ENHANZE is driving the strong total brand growth. According to analyst estimates, DARZALEX's annual sales are projected to exceed $17 billion in 2028. This growth from $9.7 billion in 2023 will be driven by continued growth in the frontline setting.
強生公司也評論稱,市場持續成長。在美國皮下滲透率超過 90%,在美國以外估計超過 80%。DARZALEX FASPRO 與 ENHANZE 正在推動整體品牌的強勁成長。根據分析師估計,DARZALEX 的年銷售額預計到 2028 年將超過 170 億美元。2023 年,這一成長將達到 97 億美元,這將由一線環境的持續成長推動。
In addition with Johnson & Johnson commenting of four positive Phase 3 readouts in the quarter. Growth as projected to also be fueled by potential new indications. We are pleased to note the FDA approval on July 30 for DARZALEX FASPRO with ENHANZE in newly diagnosed transplant eligible patients with multiple myeloma, further expanding the frontline indications.
此外,強生公司也評論了本季四項積極的第三階段數據。預計的成長也將受到潛在新適應症的推動。我們很高興地註意到 FDA 於 7 月 30 日批准 DARZALEX FASPRO 聯合 ENHANZE 用於新診斷的適合移植的多發性骨髓瘤患者,進一步擴大了一線適應症。
I'll move now to Phesgo on slide 7. Sales of Roche's Phesgo, which is a fixed-dose combination of Perjeta and Herceptin, increased 60% to almost CHF800 million in the first six months of this year. With strong growth momentum in the number of launch countries increased to 51 countries and conversion of projects over 41% in the quarter. Roche expects global conversion to reach 50% by 2026. Notably, there remains substantial opportunity with projected revenue of CHF1.9 billion in the first half of this year.
現在我將轉到幻燈片 7 上的 Phesgo。羅氏公司的 Phesgo(Perjeta 和 Herceptin 的固定劑量組合)今年前六個月的銷售額成長了 60%,達到近 8 億瑞士法郎。由於成長勢頭強勁,本季啟動國家數量增至 51 個,專案轉換率超過 41%。羅氏預計到 2026 年全球轉換率將達到 50%。值得注意的是,今年上半年的預計收入將達到 19 億瑞士法郎,仍有巨大的機會。
Let me now turn to our three products and product candidates, which are shown on slide 8. The opportunity for Wave 3 remains meaningful with analysts and companies projections of total parent product sales of approximately $35 billion in 2028. With two of our Wave 3 products already on the market today and at least one major region.
現在讓我談談我們的三種產品和候選產品,如幻燈片 8 所示。分析師和公司預測 2028 年母產品總銷售額約為 350 億美元,因此 Wave 3 的機會仍然很有意義。目前,我們的兩款 Wave 3 產品已在至少一個主要地區上市。
We expect launches to continue throughout this year and remain on track to 10 partner products within hand on the market in 2025. When you start with BiPar, Hulu, which is the subcutaneous version of five part with and hence, I will begin with the exciting news of the CIDP indication approval. In June, the FDA approved for CIDP additive second indication for (BiPar, Hulu) in the United States.
我們預計今年將繼續推出產品,並預計在 2025 年將 10 種合作夥伴產品推向市場。當您開始使用 BiPar、Hulu(這是五部分的皮下版本)時,我將從 CIDP 適應症批准的令人興奮的消息開始。6月,FDA在美國批准了CIDP添加劑(BiPar、Hulu)的第二個適應症。
CIDP is a subcutaneous only indications. Organic also announced that the European regulatory filing for CIDP was submitted to the EMA in June and a decision is anticipated in 2025. Babcock HER2-low is the first and only neonatal FC receptor blocker approved for the treatment of CIDP and represents a promising new treatment option that may provide patients with the ability to treat their disease beyond just managing symptoms.
CIDP 是皮下注射的唯一適應症。Organic 也宣布,CIDP 的歐洲監管備案已於 6 月提交給 EMA,預計將於 2025 年做出決定。Babcock HER2-low 是第一個也是唯一一個被批准用於治療CIDP 的新生兒FC 受體阻斷劑,代表了一種有前途的新治療選擇,可以為患者提供治療疾病的能力,而不僅僅是控制症狀。
The label granted by the FDA supports use across the treatment paradigm. Agennix has stated its aspiration for both HER2-low to become the standard of care for CIDP patients. There are more than 40,000 CIDP patients stay in the United States. It has been highlighted at only 24,000 patients are estimated to be receiving some form of treatment for CIDP. Of these 50% of treated patients are not responding well to the current treatments are experiencing negative side effect.
FDA 授予的標籤支持在整個治療模式中使用。Agennix 表示希望 HER2-low 成為 CIDP 患者的照護標準。目前有超過 40,000 名 CIDP 患者留在美國。值得強調的是,估計只有 24,000 名患者正在接受某種形式的 CIDP 治療。在這 50% 的接受治療的患者中,目前的治療效果不佳,出現了負面副作用。
All of this support a high unmet need. Agennix has been preparing for this launch and has a strong commercial playbook in place, similarly to generalized myasthenia gravis that will initially focus on gaining coverage and access by getting payer policies in place. Their commercial strategy will focus on an audience of approximately 10,000 neurologists of whom about 72% treat both CIDP and myasthenia gravis. Based on the treatment regimen, the annual net revenue for the CIDP patient is estimated to be $450,000, which is higher than estimated by analysts further supporting the brand's growth prospects.
所有這些都支持了未滿足的高度需求。Agennix 一直在為此次發布做準備,並製定了強大的商業策略,類似於全身性重症肌無力,該策略最初將專注於透過制定付款人政策來獲得覆蓋範圍和獲得機會。他們的商業策略將重點放在約 10,000 名神經科醫生,其中約 72% 的人同時治療 CIDP 和重症肌無力。根據治療方案,CIDP患者的年淨收入預計為45萬美元,高於分析師的預期,進一步支持了該品牌的成長前景。
And we've noted the continued momentum on the generalized myasthenia gravis launch. Our Genesis [Viper] brand is already a global blockbuster, having generated more than $1 billion in its second year of launch for its first indication in generalized myasthenia gravis, and it remains on a strong growth trajectory. In the second quarter of 2024 Agennix reported $478 million in global product sales of Viper, a robust 20% quarter over quarter growth.
我們注意到全身重症肌無力上市的持續動能。我們的 Genesis [Viper] 品牌已成為全球重磅炸彈,其首次適應全身重症肌無力,在推出的第二年就創造了超過 10 億美元的收入,並且仍然保持強勁的成長軌跡。2024 年第二季度,Agnnix 報告 Viper 全球產品銷售額為 4.78 億美元,季增 20%。
By far head-to-toe is in its first full year of launch for gMG. And we're very pleased with the growing adoption and use, with the number of patients and prescribing physicians expanding and use increasing in the earlier lines of treatment for indication. In the second quarter, Agennix reported that more than 50% of the Five Star have truly patients switch from orals and 60% of the Viper HER2-low patients were new to Viper. This is consistent with the objective to grow the market.
到目前為止,gMG 正處於從頭到腳推出的第一年。我們對越來越多的採用和使用感到非常高興,隨著患者和處方醫生數量的擴大以及早期治療適應症的使用增加。第二季度,Agennex 報告稱,超過 50% 的五星級患者真正從口服藥物轉為口服藥物,60% 的 Viper HER2 低患者是 Viper 的新患者。這與擴大市場的目標是一致的。
We also expect continued ease of access following the granting of the J-code for head-to-toe in January of this year. We're also excited to hear Agennix recently update and highlight that they believe the opportunity for myasthenia gravis is higher than their initial expectations. The opportunity increased 3.5 times from approximately 17,000 patients at launch for the MTSL choline receptor antibody positive patients to now up to 60,000 patients, including the expectation for new indications for seronegative and ocular myasthenia gravis as well as growth driven by the availability of biologics.
我們還預計,繼今年 1 月授予從頭到腳的 J 代碼後,訪問將繼續變得輕鬆。我們也很高興聽到 Agennix 最近更新並強調他們相信重症肌無力的機會高於他們最初的預期。這項機會從推出時針對MTSL 膽鹼受體抗體陽性患者的約17,000 名患者增加到目前的60,000 名患者,增加了3.5 倍,其中包括對血清陰性和眼部重症肌無力新適應症的預期,以及生物製劑可用性驅動的成長。
Organics, is also planning to introduce a new more convenient delivery option for Viper HER2-low with a prefilled syringe with the goal of supporting additional patient self-administration. An application for US regulatory approval for the prefilled syringe provides that HER2-low Viper in both CIDP and generalized myasthenia gravis was recently submitted.
Organics 還計劃為 Viper HER2-low 引入一種新的、更方便的預裝注射器輸送選項,目的是支援更多患者自行給藥。美國監管機構批准預充式註射器的申請顯示,最近已提交用於治療 CIDP 和全身性重症肌無力的 HER2-low Viper。
The prefilled syringe is expected to continue to expand and reinforce their momentum as the biologic market continues to grow. Again, also recently initiated two registrational studies evaluating byproduct treated with hand administered by prefilled syringe for thyroid eye disease, representing another attractive future opportunity.
隨著生物製品市場的持續成長,預充式註射器預計將繼續擴大並增強其發展勢頭。最近也啟動了兩項註冊研究,評估透過預充式註射器手動注射治療甲狀腺眼疾的副產品,這代表著另一個有吸引力的未來機會。
Let me move now to [Tecentriq] subcutaneous with enhanced with approvals already granted in Europe and Great Britain for all approved indications of Tecentriq IV. Roche recently commented on good uptake following the European approval. They highlighted, as an example, that 32% conversion has already been achieved in the United Kingdom following the late 2023 launch.
現在讓我談談 [Tecentriq] 皮下注射,並已在歐洲和英國獲得批准,適用於 Tecentriq IV 的所有批准適應症。羅氏最近評論稱,在歐洲獲得批准後,該產品獲得了良好的採用。例如,他們強調,自 2023 年底推出以來,英國已實現 32% 的轉換率。
We're excited for the US approval, which is projected by September 15, 2024, based on the producer action date. Annual sales of Tecentriq IV remain stable and generated [CHF1.8] billion year to date. Roche has commented that they expect the majority of the subcutaneous use will come from patients switching from Tecentriq intravenous.
我們對美國的批准感到興奮,根據生產商行動日期,預計批准時間為 2024 年 9 月 15 日。Tecentriq IV 的年銷售額保持穩定,迄今已創造 [1.8] 億瑞士法郎。羅氏表示,他們預計大部分皮下注射將來自從 Tecentriq 靜脈注射轉為靜脈注射的患者。
Moving on to Ocrevus subcutaneous was enhanced, as I mentioned earlier in June, Roche received approval of a subcutaneous in Europe for relapsing and primary progressive multiple sclerosis. In the United States Ocrevus subcutaneous has a PDUFA action date of September 13, 2024. The Ocrevus and remains a market leader in the US and EU 5 was 26% global patient share. With 350,000 patients treated to date and 1 million patient years in cumulative exposure.
接下來,Ocrevus 皮下注射得到了增強,正如我在 6 月早些時候提到的,羅氏在歐洲獲得了皮下注射治療復發性和原發性進行性多發性硬化症的批准。在美國,Ocrevus 皮下注射的 PDUFA 生效日期為 2024 年 9 月 13 日。Ocrevus 仍然是美國和歐盟 5 市場的領導者,佔全球病患份額的 26%。迄今已治療了 35 萬名患者,累積接觸量為 100 萬名患者年。
Octopus continues to capture a higher retention rate than other multiple sclerosis medicines. In the first half of the year, Ocrevus sales grew 8% to approximately CHF3.4 billion. With the recent European and upcoming US approval for the subcutaneous formulations enhance. Ocrevus subcutaneous, presenting meaningful new opportunity to reach more patients to reduce the burden for patients receiving treatment and to relieve pressures on the health care system.
與其他多發性硬化症藥物相比,章魚繼續獲得更高的保留率。上半年,Ocrevus 銷售額成長 8%,達到約 34 億瑞士法郎。隨著最近歐洲和即將到來的美國批准皮下注射劑型的增強。Ocrevus 皮下注射,為接觸更多患者提供了有意義的新機會,以減輕接受治療的患者的負擔並減輕醫療保健系統的壓力。
This will drive both market growth and the conversion opportunity. On its most recent earnings call, Roche noted that they are already seeing strong uptake in the early launch countries in Europe and reiterated that they see Ocrevus subcutaneous be standalone blockbuster opportunity with an incremental $2 billion in sales opportunity beyond the IV.
這將推動市場成長和轉換機會。在最近的財報電話會議上,羅氏指出,他們已經看到歐洲早期推出國家的強勁增長,並重申他們認為Ocrevus 皮下注射是獨立的重磅產品,除了IV 之外,還有20 億美元的增量銷售機會。
Turning now to Bristol-Myers Squibb's nivolumab subcutaneous with ENHANZE. In the United States we look forward to potential FDA approval with the updated action date of December 29, 2024. The European submission was accepted in June, and we project potential approval in mid 2025. Nivolumab Opdivo IV sales grew 16%, excluding FX in the second quarter to $2.4 billion showing continued strong performance.
現在轉向百時美施貴寶的 nivolumab 皮下注射 ENHANZE。在美國,我們期待獲得 FDA 的批准,更新行動日期為 2024 年 12 月 29 日。歐洲提交的文件於 6 月被接受,我們預計可能在 2025 年中期獲得批准。第二季 Nivolumab Opdivo IV 銷售額成長 16%(不含外匯),達到 24 億美元,表現持續強勁。
Subcutaneous enrollment has the potential to significantly reduce administration time for patients using Opdivo by utilizing a single injection in just three to five minutes supporting BMS expectation that at least 30% to 40% of US patients will convert from IV to subcutaneous with an expectation that the subcutaneous label will cover up to 75% of the IV indications, and we've noted amivantamab subcutaneous with enhanced.
皮下入組有可能顯著減少使用Opdivo 的患者的給藥時間,只需三到五分鐘即可進行單次注射,這支持了BMS 的預期,即至少30% 至40% 的美國患者將從靜脈注射轉換為皮下注射,並預計皮下注射標籤將覆蓋高達 75% 的靜脈注射適應症,我們注意到阿米萬他單抗皮下注射具有增強作用。
Amivantamab subcutaneous is on track for potential launch in 2025. This could represent our 10th approved product, Johnson & Johnson has commented that this is another blockbuster product opportunity and the amivantamab will have a significant place in frontline non-small cell lung cancer given the high unmet need and the strength of the telemetry data. It recently highlighted the reduced treatment administration time and reduced infusion-related reaction as key to supporting this multibillion-dollar opportunity.
阿米萬他單抗皮下注射預計於 2025 年上市。這可能是我們的第10 個獲批產品,強生公司評論說,這是另一個重磅產品機會,鑑於未滿足的需求和遙測數據的強度,阿米萬他單抗將在一線非小細胞肺癌中佔有重要地位。它最近強調減少治療管理時間和減少輸液相關反應是支持這一數十億美元機會的關鍵。
I will now move to slide 9, for a quick highlight of our Wave four pipeline, which is expected to contribute to our future growth trajectory with potential launches for ways for in the 2026 to 2027 timeframe. We have six products currently in development, reflecting a range of therapeutic areas including oncology, neurology, immune disease and HIV. Two products are currently in Phase 3 development, Takeda's immune globulin 20% tech [881] with N of BMS's nivolumab relent on that fixed dose combination subcutaneous with ENHANZE.
我現在將轉到投影片 9,快速重點介紹我們的第四波管道,預計這將有助於我們未來的成長軌跡,並可能在 2026 年至 2027 年期間推出一些方法。我們目前正在開發六種產品,涵蓋腫瘤學、神經病學、免疫疾病和愛滋病毒等一系列治療領域。兩種產品目前正處於第 3 期開發階段,即武田 (Takeda) 的免疫球蛋白 20% tech [881],其中 BMS 的納武單抗 (nivolumab) 與 ENHANZE 皮下注射的固定劑量組合有所緩解。
These Phase 3 studies are continuing to progress. These broadly neutralizing antibody and six last for HIV advanced into Phase 2 testing several months ago and also continued correct.
這些第三階段研究正在繼續取得進展。這些廣泛中和抗體和六種 HIV 抗體在幾個月前進入了第二階段測試,並且仍然正確。
Let me now move to Newdeal progress. I mentioned earlier that we're delighted that acumen has progressed into Phase 1 testing of a subcutaneous version, further development of product for Alzheimer's disease Bernotat. Supporting a trend we're increasingly hearing about the introduction of SC early in development of the product.
現在讓我談談新政的進展。我之前提到,我們很高興 acumen 已進入皮下版本的一期測試,進一步開發阿茲海默症的產品 Bernotat。我們越來越多地聽到在產品開發早期引入 SC 的消息,這也支持了這一趨勢。
The goal is to provide a more convenient and accessible option for patients with Alzheimer's disease, which acumen believes will improve treatment adherence through enhanced flexibility for patients, caregivers and for providers. We continue to discuss terms with companies for ENHANZE.
目標是為阿茲海默症患者提供更方便、更容易獲得的選擇,acumen 相信這將透過增強患者、照護者和提供者的靈活性來提高治療依從性。我們將繼續與各公司討論 ENHANZE 的條款。
Recall, this is the stage of that happens prior to negotiating and signing of the collaboration and licensing agreement. In addition, technical discussions and evaluations, foreign hands on for our HCI that I mentioned in our last quarter are ongoing with multiple companies in terms of the evaluation and decision-making process.
回想一下,這是在談判和簽署合作和許可協議之前發生的階段。另外,我在上個季度提到的技術討論和評估,國外對我們HCI的實踐,在評估和決策過程方面正在與多家公司進行。
As we have described before, each company's unique, they have their own process for technology approval and then for budget approval, each of which moves at a different pace, all of these factors make it difficult to project the exact timing for signing a new deal. As the gold standard for rapid subcutaneous delivery. ENHANZE is clearly recognized as a highly derisked product with a strong safety track record and an unmatched history of global regulatory approvals and commercial success.
正如我們之前所描述的,每家公司都是獨一無二的,他們有自己的技術審批流程,然後是預算審批流程,每個流程的進展速度都不同,所有這些因素使得很難預測簽署新協議的確切時間。作為快速皮下給藥的黃金標準。ENHANZE 被明確認為是一種高度降低風險的產品,具有良好的安全記錄以及無與倫比的全球監管批准和商業成功歷史。
We were also pleased to note changes recent comments that they believe Darzalex Bass Pro with ENHANZE will fall under a separate time line for drug price negotiation with regard to inflation reduction. As we await the Part B guidance, this fully aligns with our expectations and reinforces another potential benefit for ENHANZE and the recognition of the clinical benefit it can bring for patients.
我們也很高興地註意到最近評論的變化,他們認為 Darzalex Bass Pro 與 ENHANZE 將屬於與降低通貨膨脹有關的藥品價格談判的單獨時間表。當我們等待 B 部分指南時,這完全符合我們的預期,並強化了 ENHANZE 的另一個潛在益處以及對其可為患者帶來的臨床益處的認可。
Let me now comment on our commercial portfolio, which continues to demonstrate positive momentum against the backdrop of a very large and growing market opportunity in testosterone replacement treatment, size that growth remains strong. We continue to see a clear path for our proprietary products to contribute meaningfully to EBITDA in 2028 with greater than $150 million.
現在讓我評論一下我們的商業投資組合,在睾酮替代治療市場機會非常大且不斷增長的背景下,該投資組合繼續表現出積極的勢頭,且增長依然強勁。我們繼續看到我們的專有產品有一條清晰的道路,可以在 2028 年為 EBITDA 做出超過 1.5 億美元的有意義貢獻。
Let me now hand the call over to Nicole, to discuss our financial results in more detail. Thank you Helen.
現在讓我將電話轉交給妮可,更詳細地討論我們的財務表現。謝謝海倫。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Second quarter results are on track with our plans and support our strong financial performance expectations for the full year from the continued momentum in the business. Importantly, adjusted EBITDA and diluted earnings per share growth once again outpaced the top line, reflecting the strength of our business model as we generated significant leverage from continued growth in royalty revenue.
第二季業績符合我們的計劃,並支持我們對全年強勁的財務業績預期,因為業務的持續成長勢頭。重要的是,調整後的 EBITDA 和稀釋後每股盈餘的成長再次超過了營收,反映出我們業務模式的優勢,因為我們從特許權使用費收入的持續成長中產生了巨大的槓桿作用。
Let me start with our capital allocation priorities on slide 10. In the quarter, we completed the $250 million ASR announced last November, bringing our total returns to shareholders via share repurchases to $1.3 billion over the past five years.
讓我從投影片 10 上的資本配置優先事項開始。本季度,我們完成了去年 11 月宣布的 2.5 億美元 ASR,使過去五年透過股票回購為股東帶來的總回報達到 13 億美元。
We have not included future share repurchases in our projections at this time. However, our $750 million share repurchase program authorized by the Board earlier this year allows us to continue to evaluate share repurchases to drive shareholder value depending on market conditions and other factors. We will continue with a balanced approach as we deploy capital to grow the business and evaluate opportunities to unlock additional growth through M&A.
我們目前尚未將未來的股票回購納入我們的預測中。然而,今年稍早董事會批准的 7.5 億美元股票回購計畫使我們能夠繼續評估股票回購,以根據市場狀況和其他因素提高股東價值。我們將繼續採取平衡的方法,部署資本來發展業務,並評估透過併購釋放額外成長的機會。
We maintained a strong balance sheet with cash, cash equivalents and marketable securities of $529 million on June 30, 2024, compared to $463.5 million on March 31, 2024. The increase was primarily a result of cash generated from operations. Our net leverage ratio was 1.8 times at the end of the quarter and we expect to continue to reduce our net leverage ratio as EBITDA continues to grow.
截至 2024 年 6 月 30 日,我們維持了強勁的資產負債表,現金、現金等價物和有價證券為 5.29 億美元,而 2024 年 3 月 31 日為 4.635 億美元。增加的主要原因是營運產生的現金。截至本季末,我們的淨槓桿率為 1.8 倍,隨著 EBITDA 的持續成長,我們預計將繼續降低淨槓桿率。
Turning now to slide 11, for our detailed financial results for the second quarter. Revenue grew 5% to $231.4 million compared to $221 million in the prior year period. Loyalty revenues for the quarter were $124.9 million, an increase of 12% compared to $111.7 million in the prior year period.
現在轉向投影片 11,了解我們第二季的詳細財務表現。營收成長 5%,達到 2.314 億美元,而去年同期為 2.21 億美元。本季的忠誠度收入為 1.249 億美元,比去年同期的 1.117 億美元成長 12%。
The commercial success of currently approved Wave 2 products, subcutaneous DARZALEX and Phesgo continue to drive royalty revenue growth. Growth in the second quarter was partially offset by a temporary royalty rate reduction for Darzalex SC in Europe in March, with the full royalty rate reinstated in June. The second quarter also benefited from higher expected API sales, reflecting a demand shift from the third quarter to the second quarter.
目前批准的第 2 波產品、皮下 DARZALEX 和 Phesgo 的商業成功繼續推動特許權使用費收入的成長。第二季的成長被 3 月歐洲 Darzalex SC 特許權使用費率暫時降低所部分抵消,6 月恢復了全額特許權使用費率。第二季也受惠於 API 銷售預期的增加,反映出需求從第三季轉向第二季。
Similarly, collaboration revenue was higher than anticipated due to the achievement of two milestones previously expected to take place in the third quarter, Bristol's MAA acceptance and acumen Phase 1 milestone. Research and development expenses were $21 million compared to $19.7 million in the prior year period. The increase was primarily due to planned investments in ENHANCE related to the development at our new high yield API manufacturing process.
同樣,由於實現了先前預計在第三季度實現的兩個里程碑,即布里斯託的 MAA 驗收和敏銳的第一階段里程碑,協作收入高於預期。研發費用為 2,100 萬美元,去年同期為 1,970 萬美元。這一增長主要是由於計劃對 ENHANCE 進行投資,該投資與我們新的高產量 API 製造流程的開發相關。
Selling, general and administrative expenses were down to $35.7 million in the quarter, from $38.9 million in the prior year period, primarily due to planned reductions in commercial marketing expense. Adjusted EBITDA increased 19% to $137 million from $115.1 million last year.
本季的銷售、一般和管理費用從去年同期的 3,890 萬美元降至 3,570 萬美元,這主要是由於計劃削減商業行銷費用。調整後 EBITDA 成長 19%,從去年的 1.151 億美元增至 1.37 億美元。
GAAP diluted earnings per share was $0.72 and non-GAAP diluted earnings per share was $0.91. This is compared with GAAP diluted earnings per share of $0.56 and non-GAAP diluted earnings per share of $0.74 in the second quarter of 2023.
GAAP 攤薄每股收益為 0.72 美元,非 GAAP 攤薄每股收益為 0.91 美元。相比之下,2023 年第二季 GAAP 攤薄每股收益為 0.56 美元,非 GAAP 攤薄每股收益為 0.74 美元。
Turning now to slide 12 and our 2024 guide. Recall, we previously raised our full year 2024 guidance in June of this year to reflect the issuance of the new European patent for our enhanced drug delivery platform. With our solid first half financial performance and upcoming partner milestones. We are reiterating our full year 2024 guidance of revenues of $935 million to $1,015 million. Royalty revenues of $520 million to $555 million, adjusted EBITDA between $555 million and $615 million and non-GAAP diluted EPS of $3.65 to $4.05.
現在轉向幻燈片 12 和我們的 2024 年指南。回想一下,我們先前於今年 6 月上調了 2024 年全年指引,以反映我們增強型藥物輸送平台新歐洲專利的發布。憑藉我們上半年穩健的財務表現和即將到來的合作夥伴里程碑。我們重申 2024 年全年營收指引為 9.35 億至 10.15 億美元。特許權使用費收入為 5.2 億至 5.55 億美元,調整後 EBITDA 為 5.55 億至 6.15 億美元,非 GAAP 攤薄後每股收益為 3.65 至 4.05 美元。
As you refine your model, I would also like to reiterate the following. The second quarter benefited from the pull forward of API sales and two milestones achieved previously expected in the third quarter. Therefore, product sales and collaboration revenue in the third quarter is expected to be flat to the second quarter.
當您完善模型時,我還想重申以下內容。第二季受益於 API 銷售的成長以及先前預期在第三季實現的兩個里程碑。因此,第三季的產品銷售和協作收入預計將與第二季持平。
Royalties are expected to see sequential growth in the third and fourth quarter, driven by a full quarter impact of the new EUIP, non-GAAP diluted EPS growth of 32% to 46% reflect gross margin expansion from revenue mix and the full year impact of share repurchase activity in 2023.
受新EUIP 全季影響的推動,特許權使用費預計將在第三季和第四季出現環比增長,非GAAP 攤薄後每股收益增長32% 至46%,反映了收入組合的毛利率擴張以及全年影響2023 年的股票回購活動。
With that, I will now turn the call back over to Helen.
這樣,我現在將把電話轉回給海倫。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Thank you, Nicole. Our second quarter results highlight the strength of our durable high-growth business model and successful execution against our growth plan. As shown on slide 13. Our strong pipeline of launches this year and beyond gives us both clear line of sight to the growth of our business and confidence in achieving our 5-year financial targets.
謝謝你,妮可。我們第二季的業績凸顯了我們持久高成長業務模式的實力以及我們成長計畫的成功執行。如投影片 13 所示。我們今年及以後推出的強大產品系列使我們對業務成長有清晰的認識,並對實現 5 年財務目標充滿信心。
Awareness and appreciation of subcutaneous technology around the globe continues to grow, and we are well positioned to capitalize on these emerging opportunities. I remain confident and very excited for Halozyme future I want to close by thanking our terrific Halozyme team and our partners and collaborators for their hard work that resulted in an exciting and strong first half of the year.
全球對皮下技術的認識和欣賞不斷增強,我們已做好充分利用這些新興機會的準備。我對Halozyme 的未來仍然充滿信心和興奮,我想在結束時感謝我們出色的Halozyme 團隊以及我們的合作夥伴和合作者的辛勤工作,正是他們的辛勤工作才帶來了令人興奮和強勁的上半年。
Operator, we are now ready to open the call for questions.
接線員,我們現在準備開始提問。
Operator
Operator
(Operator Instructions)
(操作員說明)
Jason Butler, Citizen's JMP.
Jason Butler,公民 JMP。
Jason Butler - Analyst
Jason Butler - Analyst
Hi. Thanks for taking the questions and congrats on the quarter. Helen, wondering if you could just once again give us an overview of as you look at the new partnership or expanded partnership activities, where is it weighted between Enhanze alone versus it has an auto-injector? And and again, I understand that timing can be predicted, but just again, your confidence level on on seeing deals this year? Thanks.
你好。感謝您提出問題並祝賀本季。海倫,想知道您是否可以再次向我們概述一下,當您考慮新的合作夥伴關係或擴大的合作夥伴活動時,單獨使用 Enhanze 與配備自動注射器相比,它的權重在哪裡?再說一遍,我知道時間是可以預測的,但再說一遍,您對今年交易的信心程度如何?謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah, thanks, Jason. And yes, we are confident in signing additional deals. And what really gives us that confidence is the breadth of conversations that we're having. I would say the deals are more weighted to enhance on its own. But there are conversations happening, of course, with the HVI, which requires enhance.
是的,謝謝,傑森。是的,我們有信心簽署更多協議。真正給我們信心的是我們正在進行的廣泛對話。我想說的是,這些交易更注重自身的提升。但當然,與 HVI 正在進行對話,這需要加強。
And obviously also conversations related to HVI with partners who have already I'm taken in hand, so anomalies, some mix of some conversation, large pharmas also biotech companies entering from established products and also including products that are early in development, which we do like to see that big is becoming such an increasing trend that everybody is recognizing the value of subcu for patients and for the healthcare system. So a very nice breadth of those conversations and probably more weighted to enhance, Jason.
顯然,也與我已經掌握的合作夥伴進行了與HVI 相關的對話,因此存在異常現象,一些對話的混合,大型製藥公司以及生物技術公司從成熟的產品進入,也包括處於早期開發的產品,我們這樣做希望看到「大」正在成為日益增長的趨勢,以至於每個人都認識到 subcu 對患者和醫療保健系統的價值。傑森,這些對話的範圍非常廣,而且可能更需要加強。
Jason Butler - Analyst
Jason Butler - Analyst
Great. And then just one follow-up. I think probably from the call and just the VAPI sales were higher than expected in 2Q. What drove that? And I guess just what gives you that the line of sight that you'll you'll be flat quarter over quarter into 3Q?
偉大的。然後只有一個後續行動。我認為第二季的電話銷售和 VAPI 銷售額可能高於預期。是什麼推動了這一點?我猜是什麼讓你認為第三季與季度持平?
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah. Thanks for that, Jason. So when we look at our API sales, we do tried to lay out that quarterly cadence, but those can shift quarter to quarter. So we did just see and we have the ability to do that too because of our ample supply. So with a partner needs a little bit earlier than originally expected. We can make those fluctuations.
是的。謝謝你,傑森。因此,當我們查看 API 銷售情況時,我們確實嘗試制定季度節奏,但這些節奏可能會逐季變化。所以我們確實看到了,而且由於我們供應充足,我們也有能力做到這一點。因此與合作夥伴的聯繫需要比最初預期的要早一點。我們可以做出這些波動。
And so that is what we saw. We do still have line of sight to full year expectations and that remains unchanged, but we did see a shift earlier in the year, so from the third quarter to the second quarter, which now leads to our expectations for that flattening because we've accelerated from the third quarter previously. The third quarter was going to have growth. Now at this time, we expect a flattening from the second quarter to the third quarter, really again just based on our on our partners and the orders that we expect at this time for growth.
這就是我們所看到的。我們仍然對全年預期保持不變,但我們確實在今年早些時候看到了變化,從第三季度到第二季度,這導致我們對全年預期趨於平緩,因為我們已經較之前第三季度有所加速。第三季將會出現成長。現在,我們預計第二季到第三季將持平,這實際上也是基於我們的合作夥伴以及我們目前預期的成長訂單。
Jason Butler - Analyst
Jason Butler - Analyst
Thanks for taking the questions.
感謝您提出問題。
Operator
Operator
Serena Chen, Wells Fargo.
小威陳,富國銀行。
Serena Chen - Analyst
Serena Chen - Analyst
Hey, thanks for taking my question. This Serena on behalf of Mohit Bansal, wanted to ask about potential partnerships, especially given all the enthusiasm about the myostatin pathway on. It seems like drugs here seem to be very high dose. And was wondering if that's something that you could partner with using your technology. Thank you.
嘿,謝謝你回答我的問題。Serena 代表 Mohit Bansal,想詢問潛在的合作夥伴關係,特別是考慮到人們對肌肉生長抑制素途徑的熱情。看來這裡的藥物劑量似乎很高。我想知道您是否可以使用您的技術來合作。謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes, I can say that we certainly are interested and obviously areas of obesity, obesity with muscle loss that are very hot areas. And we do like to target those types of areas to look at the companies that are involved there, look at their products to see if that be a good fit for ENHANZE and we approach those companies. And so insofar as we're seeing any fits there, Serena, I know that we will be we'll have already reached out to those companies to initiate discussions with that because that's exactly how we like to target new opportunities.
是的,我可以說我們當然感興趣,而且顯然對肥胖、肥胖伴隨肌肉流失的領域很感興趣,這是非常熱門的領域。我們確實希望針對這些類型的領域來研究參與其中的公司,研究他們的產品,看看是否適合 ENHANZE,然後我們與這些公司接洽。因此,只要我們看到任何合適的地方,小威,我知道我們已經與這些公司聯繫並開始討論,因為這正是我們尋找新機會的方式。
Serena Chen - Analyst
Serena Chen - Analyst
Thank you.
謝謝。
Operator
Operator
Jessica Fye, JP Morgan.
潔西卡法耶,摩根大通。
Jessica Fye - Analyst
Jessica Fye - Analyst
Great. Good afternoon and thanks for taking my questions. I had a couple. When might we hear more about the undisclosed Roche and Chugai products on your way for slide? And can you say if those are subcu versions of approved IV drugs? Or are these products being developed as subcu from the start?
偉大的。下午好,感謝您提出我的問題。我有一對。我們什麼時候可以在您的幻燈片中聽到更多有關未公開的羅氏和中外產品的資訊?您能說一下這些是否是已批准的靜脈注射藥物的 subcu 版本嗎?或者這些產品從一開始就是作為 subcu 開發的?
And then maybe thinking that I piggyback on Jason's question and last quarter, you came out very strong on the commentary around potential new partnerships, taking that discussion to several companies in the terms stage and what's the latest you can tell us for how many of those conversations are still live pure, maybe new ones have popped up, but I'm curious if there's been any attrition from the ones that were live as of last quarter? And I guess related to partnering. Can you speak to how the prolonged three results have impacted discussions with potential partners, if at all?
然後也許認為我順應了傑森的問題,上個季度,您對圍繞潛在新合作夥伴關係的評論非常強烈,在條款階段對幾家公司進行了討論,您可以告訴我們其中有多少家公司是最新的嗎?我想這與合作有關。您能否談談長期的三項結果如何影響與潛在合作夥伴的討論(如果有的話)?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yeah. Great. Thanks, Jes. Let me start with the undisclosed targets. You're absolutely right. We've got two undisclosed targets, one voice, one shoe guy that is on the Wave four slides, unfortunately, because those are partner confidential were unable to say anything about them, including whether they are subcu versions of already approved IV products and the partners have given us no indication at this point in time of any near term plans to disclose what those targets are.
是的。偉大的。謝謝,傑斯。讓我從未公開的目標開始。你是絕對正確的。我們有兩個未公開的目標,一個聲音,一個鞋子人,他們都在第四波幻燈片上,不幸的是,因為這些是合作夥伴機密,我們無法透露任何有關他們的信息,包括它們是否是已經批准的IV 產品的subcu 版本以及目前合作夥伴尚未向我們表明任何近期計劃披露這些目標是什麼。
So generally we find that company that partners who were feeling there in a competitive space or perhaps just because of their preference to not to disclose the targets and we obviously have to abide by that. So obviously, we're excited to talk about those when we can, but not we can't see anything at the moment.
因此,一般來說,我們發現那些感覺自己處於競爭性空間中的合作夥伴,或者可能只是因為他們傾向於不披露目標,我們顯然必須遵守這一點。顯然,我們很高興能在可能的情況下談論這些,但目前我們什麼也看不見。
With regard to the terms discussing, you know, as we mentioned, we are continuing in terms of discussions with companies as well as additional companies that are more in the technical evaluation stage at so each company is moving at its own pace. And while I would love to be able to give more granularity about what exactly is happening and there's not an intermediate place really between initiating the terms discussion and signing the CLA that I can talk about.
關於討論的條款,正如我們所提到的,我們正在繼續與公司以及更多處於技術評估階段的其他公司進行討論,因此每家公司都在按照自己的步調前進。雖然我希望能夠更詳細地了解到底發生了什麼,但在啟動條款討論和簽署我可以談論的 CLA 之間實際上沒有中間位置。
And so it does make it seem like when we announced the deal, it appears all of a sudden, but we do want to make sure that we're giving you the most up-to-date information. So you'll hear about it when the CLAs are actually signed. And for telemetry, obviously for everybody that was exciting data where and explore in addition to expected results, which was a fivefold reduction in infusion related reactions and also the dramatically shorter treatment time, there was an interesting exploratory signal with regard to a an improved or overall survival in the subcu arm.
因此,當我們宣布這項交易時,確實看起來像是突然發生的,但我們確實希望確保為您提供最新的資訊。因此,當 CLA 實際簽署時您就會聽到這一消息。對於遙測,顯然對於每個人來說,除了預期結果之外,還有令人興奮的數據和探索,即輸注相關反應減少五倍,治療時間也大大縮短,有一個有趣的探索性信號,涉及改善或subcu 組的總體存活率。
Two theory, circulate about that one was that perhaps it was the patients had higher overall exposure while still hit the non-inferiority margins, it was in over a higher exposure up, but there's a lot of interest in the idea that that's in part due to increased immune trafficking, which is happening because the drug is delivered subcutaneously and is absorbed through the lymphatics lymph nodes.
流傳的兩種理論是,也許患者有更高的整體暴露,但仍然達到非劣效性邊界,它處於更高的暴露水平,但人們對這種想法很感興趣,部分原因是增加免疫運輸,這是因為藥物是皮下輸送並透過淋巴淋巴結吸收的。
And certainly as it relates to companies who are working in areas such as nucleic acid MRNA vaccines and Jeff, that that has created an interest. And these are early conversations and obviously, there's more data to be generated here. But certainly this is a concept that some some people were aware of more people are becoming aware of and the potential to end up being able to have a higher production. As an example, as a result of subcu delivery and with ENHANZE is certainly attracting interest. That's that's about all I can say about that at this time.
當然,因為它與從事核酸 mRNA 疫苗等領域工作的公司和 Jeff 有關,這引起了人們的興趣。這些都是早期的對話,顯然,這裡還需要產生更多數據。但當然,這是一些人已經意識到的概念,越來越多的人正在意識到這個概念,並且最終有可能獲得更高的產量。例如,subcu 交付和 ENHANZE 無疑引起了人們的興趣。目前我能說的就是這些。
Jessica Fye - Analyst
Jessica Fye - Analyst
Thank you.
謝謝。
Operator
Operator
Michael DiFiore, Evercore ISI.
邁克爾·迪菲奧裡,Evercore ISI。
Michael DiFiore - Analyst
Michael DiFiore - Analyst
Hey, guys, thanks so much for taking my question and congrats on the solid quarter. Two for me. Again, to just drill down on the partnership discussions. Curious to see if how the election uncertainty and looming potential for a rate cut as in any way, influence the amount of incremental inbound partnership interest.
嘿,夥計們,非常感謝您提出我的問題,並祝賀這個季度的穩定表現。給我兩個。再次,深入探討合作關係的討論。我很想知道選舉的不確定性和迫在眉睫的降息潛力是否會以任何方式影響入境合夥人興趣的增量。
And I know And Helen, I think in back in 1Q, you said that you had like having 10 unique companies, but that our work we're kind of being cans or in the mix for partnership discussions, has that increased since those 10 companies? And then my follow-up is that kind of a housekeeping question, could we expect a true-up of your dollars like royalties that were low in 2Q prior to the extension of the EU patent?
我知道海倫,我想在第一季度,您說您希望擁有 10 家獨特的公司,但我們的工作是罐頭或混合進行合作夥伴討論,自從這 10 家公司以來,這種情況是否有所增加?然後我的後續問題是一個內務問題,我們是否可以預期您的美元會得到調整,例如歐盟專利延期之前第二季度較低的特許權使用費?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
I'll take the first one and then Nicole, can take the second one. I would say the issue of some elective uncertainty, recut, some things aren't really coming up in any of the conversations that we're having, Mike. So I can't really see. I think that is some focus for certainly the people. We are talking with them in the companies, and we are continuing in discussion with around 10 companies. And so I'd say it's still that healthy pipeline of conversations that we're having.
我會拿第一個,然後妮可可以拿第二個。我想說的是一些選擇性不確定性的問題,重新剪輯,有些事情並沒有真正出現在我們正在進行的任何對話中,麥克。所以我實在看不出來。我認為這肯定是人們關注的焦點。我們正在與他們的公司進行談判,我們正在繼續與大約 10 家公司進行討論。所以我想說,我們正在進行的對話仍然是健康的。
And we're constantly reaching out to other companies. And we do get inbounds or remember, I gave a metric before to say we're probably have more coming from our active outreach than incoming, but haven't seen any difference in that overall kind of piece and trained a toll.
我們不斷與其他公司聯繫。我們確實收到了入站數據,或者記住,我之前給出了一個指標,說我們可能從主動外展中獲得的數據比傳入的數據多,但在總體上並沒有看到任何差異,並且訓練了收費。
And certainly nothing I could attribute to anything like election uncertainty or price caps. I think for us, as you're seeing, you've heard us talk about it really is the internal reviews in companies. But as perhaps part of the governance perhaps part of their their budget cycle that we have gotten used to over the years that it just them takes time.
當然,我無法將任何事情歸咎於選舉的不確定性或價格上限。我認為對我們來說,正如您所看到的,您已經聽到我們談論的實際上是公司的內部審查。但也許是治理的一部分,也許是他們預算週期的一部分,多年來我們已經習慣了,這只是他們需要時間。
If you look back historically, we've signed about down a deal a year on average. And so we're very used to it. And we're patiently working through the process with all the companies that we're talking with and remain very excited by the breadth of the conversations, and that gives us confidence in additional new deals.
如果你回顧歷史,我們平均每年都會簽署一份協議。所以我們已經很習慣了。我們正在耐心地與所有正在與我們交談的公司合作,並對對話的廣度感到非常興奮,這讓我們對更多新交易充滿信心。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
In regards to the royalties, we're not expecting to see a true up related to the second quarter later in the year. What you saw in the second quarter was a temporary reduction in the royalties related to our Janssen product.
關於特許權使用費,我們預計今年稍後第二季不會出現真正的上漲。您在第二季度看到的是與我們的楊森產品相關的特許權使用費暫時減少。
And that was because the temporary royalty rate stepped down to 50%, and that was in that period from March to June. But now the full rate has been reinstated. So we will expect to see royalty growth in the remaining quarters of the year, but not expecting to see any true-up coming out of the second quarter.
這是因為臨時特許權使用費率降至 50%,而且是在 3 月至 6 月期間。但現在全額費率已恢復。因此,我們預計今年剩餘季度的特許權使用費將成長,但預計第二季不會出現任何實際成長。
Jessica Fye - Analyst
Jessica Fye - Analyst
Thanks so much.
非常感謝。
Operator
Operator
Mitchell Kapoor, H.C. Wainwright.
米切爾·卡普爾,H.C.溫賴特。
Mitchell Kapoor - Analyst
Mitchell Kapoor - Analyst
Hey, everyone. Thanks for taking the questions. The first one is on the 2024 guidance since it was reiterated. But given what you're seeing in the pace of revenue categories. Nicole, if you have any updated thoughts and if you could make any comments about how the composition of the revenue line items could look in 2025?
嘿,大家。感謝您提出問題。第一個是關於 2024 年指導方針的重申。但考慮到你所看到的收入類別的成長速度。Nicole,您有什麼最新的想法嗎?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
All right. I'll turn that to Nicole.
好的。我會把這個問題轉給妮可。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
And as to add, since we updated our guidance and you did see us update you more specifically just related to royalties. And so royalties are expected to exceed our prior expectations and have a higher ramp in the third and fourth quarter. But we did not change and don't have substantial changes to the rest of our royalty stream. So the composition of our revenue mix is largely tracking to our guidance that we put out in reiterated our guidance and consistent with the guidance we put out in June.
補充一點,自從我們更新了指南以來,您確實看到我們更新了與版稅相關的更具體資訊。因此,特許權使用費預計將超出我們先前的預期,並在第三和第四季出現更高的成長。但我們沒有改變,也沒有對我們的版稅流的其餘部分進行重大改變。因此,我們的收入組合的組成很大程度上遵循我們在重申的指導中提出的指導,並與我們在 6 月提出的指導保持一致。
Mitchell Kapoor - Analyst
Mitchell Kapoor - Analyst
Great, thanks. And then on the product sales, you were mentioning that sometimes a partner might request product earlier than than later, and I was wondering if that shift that we're seeing, if we're seeing that now has any bearing on the level of demand that we could be seeing and how that might read through to the future at this time, we don't have a read through on that.
太好了,謝謝。然後在產品銷售方面,您提到有時合作夥伴可能會早於晚於要求產品,我想知道我們現在看到的這種轉變是否對需求水平有任何影響我們現在可以看到,以及這可能會如何影響未來,但我們還沒有對此進行深入研究。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
And it's really just because we saw, you know, these these orders, especially when they happened post the quarter, end, they could just really shift quarter to quarter, but we don't have a read through and aren't expecting it to impact our full year projection.
這實際上只是因為我們看到,你知道,這些訂單,特別是當它們發生在季度結束後時,它們可能真的會逐季度轉移,但我們沒有仔細閱讀,也不期望它會發生變化。我們的全年預測。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
And Mitchell, I'd just add that we find that the company's zone having can change their buying patterns just based on various things that are going inside the company, they have different down amounts of safety stock.
米切爾,我想補充一點,我們發現公司的區域可以根據公司內部發生的各種事情來改變他們的購買模式,他們有不同的安全庫存量。
They want to hold. And so we have not found API demand, a good correlate for changes in the demand that we're going to see up just because not all of it is in immediately for use in the market. Some of it is for safety stock.
他們想要持有。因此,我們還沒有發現 API 需求,這是我們將看到的需求變化的良好關聯,因為並非所有 API 都會立即在市場上使用。其中一些是為了安全庫存。
Operator
Operator
Brendan Smith, TD Cowen.
布倫丹·史密斯,TD·考恩。
Brendan Smith - Analyst
Brendan Smith - Analyst
Hi, thanks for taking the questions and congrats on the good quarter. I just have a quick one on increases and then a follow-up on the supermarket. And we've been assuming that the previous subcu will still require a visit to the clinic and administration by a health care provider. Is that also kind of your expectations at this point?
您好,感謝您提出問題,並祝賀本季表現良好。我只是簡單介紹一下漲價的情況,然後跟進超市的情況。我們一直假設以前的 subcu 仍需要前往診所並由醫療保健提供者管理。這也是你目前的期望嗎?
Are you thinking there might be any flexibility for at-home administration? And then just wondering on Ardelyx's emphasis of our of do you have a sense from them how many of the four indications they've now announced will actually use the enhanced subcu. We know they're using it and MMM, but just wondering about at the MDGS. and CIDP. Thanks very much.
您認為在家管理可能有任何彈性嗎?然後只是想知道 Ardelyx 所強調的我們的,你是否從他們那裡感覺到他們現在宣布的四種適應症中有多少實際上會使用增強型 subcu。我們知道他們正在使用它和 MMM,但只是想知道 MDGS。和 CIDP。非常感謝。
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah, with regard to all of this, I think based on the clinical study has been done brand and to date on it because it was done with the setting of health care practitioner administered. I think it's very likely that the original the initial labels are going to be for in the physician's office and a simple 10-minute subcu injection. But administered in the office some and you know, it's every six months at this point out, and that is actually quite a good time point for patients to be in seeing their doctors anyway.
是的,關於所有這些,我認為基於品牌和迄今為止已經完成的臨床研究,因為它是在醫療保健從業人員管理的環境下完成的。我認為最初的標籤很可能是在醫生辦公室和簡單的 10 分鐘皮下注射中使用的。但有些是在辦公室進行的,你知道,目前每六個月一次,這實際上是病人去看醫生的一個很好的時間點。
And so that, yes, I don't know that we'll be any drive on Roche's part to want to in the patient's home because the patient is going to have to see the doctor anywhere, and it's a nice time for chicken with regard to input this rebar, Agennix has not provided any additional information with regard to that publicly. So we're not in a position to provide anything at this time.
所以,是的,我不知道羅氏公司是否會願意去病人家裡,因為病人必須在任何地方看醫生,而這對雞來說是一個好時機。資訊.所以我們目前無法提供任何東西。
Brendan Smith - Analyst
Brendan Smith - Analyst
Great. Thank you.
偉大的。謝謝。
Operator
Operator
David Risinger, Leerink Partners.
大衛‧瑞辛格 (David Risinger),Leerink 合夥人。
Unidentified Particiant
Unidentified Particiant
Hi, everyone. Congrats on a strong quarter and thank you for taking my questions. Is Jason for David. I have two questions for me, please. First one is following the strong 2Q performance. How should we think about maintenance of full year guidance as well as Q3 and Q4 sequential modeling considerations?
大家好。恭喜季度表現強勁,並感謝您回答我的問題。傑森是大衛。我有兩個問題想問我。第一個是第二季強勁的表現。我們應該如何考慮維持全年指引以及第三季和第四季順序建模考量?
Second question is, are you still expecting to sign major new enhanced data? Is near term for this year, future blockbuster drugs. Thanks so much.
第二個問題是,您是否仍期待簽署重大的新增強資料?是今年近期未來的重磅藥物。非常感謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes, I'll ask Nicole to uptake the first one and just maybe again talk about the maintenance of the full-year guidance. And just the flavor of the next two quarters?
是的,我會請妮可接受第一個,也許會再次談論全年指導的維護。只是接下來兩個季度的風味嗎?
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah, happy to. So our second quarter performance is tracking with our full year guidance. And so no change to the guidance that is tracking as we expected and supports our full year view. And then in particular for cadence for the third quarter and the fourth quarter, we do expect the third quarter to be flat when we look at API sales, as we mentioned.
是的,很高興。因此,我們第二季的業績與全年指引相符。因此,按照我們的預期追蹤並支持我們全年觀點的指引沒有變化。然後,特別是對於第三季和第四季的節奏,正如我們所提到的,當我們查看 API 銷售時,我們確實預計第三季將持平。
And also when I look at collaboration revenue, I'd also mentioned we saw some milestones pull-in that originally were expected in the third quarter. Those happened in the second quarter. And so that is also driving our expectation that and milestones or collaboration revenue will be flat on second quarter. The third quarter.
此外,當我查看協作收入時,我還提到我們看到了一些最初預計在第三季實現的里程碑。這些發生在第二季。因此,這也推動了我們的預期,即第二季的里程碑或協作收入將持平。第三季。
But when I look at royalties, we know that we expect to see growth in the second half of the year and sequential growth in the third quarter and the fourth quarter. And that's really reflecting not only the growth in the underlying brands in our royalty streams, but also reflecting a full full quarter of our royalty rate being at the full rate back that was reinstated in June for on Darzalex already done with regard to the deal progress, and we certainly are excited to be in a range of discussions, including terms discussions and technical discussions with other companies.
但當我查看特許權使用費時,我們知道我們預計下半年會成長,第三季和第四季也會出現環比成長。這不僅反映了我們的特許權使用費流中基礎品牌的成長,而且還反映了我們整個季度的特許權使用費率恢復到了6 月份恢復的全額費率,Darzalex 已經在交易進展方面完成了這項工作,我們當然很高興能夠參與一系列討論,包括與其他公司的術語討論和技術討論。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
And as we talked about in predicting the exact timing of a deal, it's very hard because each company is different and that's influenced very much by their governance, but also their budgeting process. And so what I can say is that based on the breadth of discussions, we are very confident in new deals, big absolutely could happen this year and there's a range of things to your question on.
正如我們在預測交易的確切時間時所談到的,這非常困難,因為每家公司都是不同的,這在很大程度上受到他們的治理以及預算流程的影響。所以我可以說的是,根據討論的廣度,我們對新交易非常有信心,今年絕對可能發生大交易,你的問題涉及很多方面。
Will it be an established product that's already commercialized? Will it be a product that's being subcu right from the start, it certainly could possibly be one or either or both. And it really is them if they were at this stage of just working through this within the companies and their systems. But we're very pleased to have this range, obviously of the established blockbuster IV subcu conversion.
它會是一個已經商業化的成熟產品嗎?它是否是從一開始就被subcu的產品,它肯定可能是其中之一,或者其中之一,或者兩者兼而有之。如果他們正處於公司及其係統內解決這個問題的階段,那麼這確實是他們。但我們很高興擁有這個系列,顯然是已建立的重磅炸彈 IV subcu 轉換。
That's worked very well for us, but we're seeing so much interest now in subcu and extended dosing as a place people are going and that being offering something very important for patients, but also competitive differentiation for the product. So all of that is entirely possible and we were just have to work through the system. And obviously, we are excited to provide updates as soon as we're in a position to move past these in terms of discussions into the upsizing of the CLA.
這對我們來說非常有效,但我們現在看到人們對 subcu 和延長劑量非常感興趣,這不僅為患者提供了非常重要的東西,而且也為產品提供了競爭優勢。因此,所有這一切都是完全可能的,我們只需透過系統進行工作即可。顯然,一旦我們能夠在擴大 CLA 規模的討論中超越這些內容,我們很高興能夠立即提供最新資訊。
Operator
Operator
Vikram Purohit, Morgan Stanley.
維克拉姆‧普羅希特,摩根士丹利。
Vikram Purohit - Analyst
Vikram Purohit - Analyst
Hi, good afternoon. Thank you for taking our question. We had one on capital allocation and business development. So how does potential M&A factor into your thinking and what profile of business do you think could be a good fit for Halozyme at the Company's current stage of maturity? And how much would you be willing to flex that? And 1.8x leverage ratio for potential BD? Thanks.
嗨,下午好。感謝您提出我們的問題。我們有一個關於資本配置和業務發展的問題。那麼,潛在的併購是如何影響您的想法的?你願意在多大程度上改變這件事?潛在 BD 的槓桿率為 1.8 倍?謝謝。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
I'll take the first part and I'll ask Nicole, to comment on the final question there on the leverage. So will we continue to be very actively looking and we do believe that if we can find the right M&A, that is a great use of our capital and a great way to return value to our shareholders. And we continue our disciplined approach, and we are looking ideally at some businesses such as in drug delivery that are licensing models to be a great fit with our current TAM.
我將討論第一部分,然後請妮可評論關於槓桿的最後一個問題。因此,我們會繼續非常積極地尋找,我們相信,如果我們能夠找到正確的併購,這是對我們資本的充分利用,也是為股東回報價值的好方法。我們將繼續採取嚴格的方法,我們正在理想地尋找一些業務,例如藥物輸送領域,這些業務的授權模式非常適合我們目前的 TAM。
Our business model but also our financial profile, given the high margins that exist or importantly, we're looking for things that have got a meaningful revenue stream and durable revenues to be a fit with the financial profile of the company as well.
我們的商業模式以及我們的財務狀況,考慮到現有的高利潤率,或者重要的是,我們正在尋找具有有意義的收入來源和持久收入的東西,以適應公司的財務狀況。
So looking at drug delivery, but we also are looking and that you can imagine there are other businesses where there are technologies that pharma and biotech needs to license for them to, for example, create new drugs. And these are already established businesses, and that is another great fit for our skills and for our business model.
因此,我們著眼於藥物輸送,但我們也在尋找,你可以想像還有其他企業,其中製藥和生物技術公司需要獲得許可才能使用技術,例如,創造新藥。這些都是已經成熟的業務,這也非常適合我們的技能和商業模式。
And so we're very active looking there as well as ever. We will be patient with demonstrated strong patients out. We need to have something that's got the right derisked asset with the potential to grow where we see a meaningful contribution to our revenue and durable revenue and as a result of it. So hopefully more to come on that. But down or very active there. Nicole, do you want to talk about leverage?
因此,我們一如既往地非常積極地在那裡尋找。我們會耐心地把表現堅強的病人拿出來。我們需要擁有適當的去風險資產,並具有成長潛力,我們認為對我們的收入和持久收入做出了有意義的貢獻,並因此而成長。所以希望能有更多這樣的事情發生。但那裡還是很活躍的。妮可,你想談談槓桿嗎?
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Nicole Labrosse - Chief Financial Officer, Senior Vice President
Yeah. When I when I look at our current leverage in really what I think about it and how Alan described is what is the pro forma delevering profile. So that would be a really important factor.
是的。當我真正審視我們目前的槓桿率時,我的想法以及艾倫所描述的是什麼是預期的去槓桿化概況。所以這將會是一個非常重要的因素。
When I think about how high would go from a leverage perspective, I'll give you the example that for the Antares acquisition, we levered up to 3.3 times. And as you mentioned, we were able to delever and we're now at less than two times so that our profile where we have line of sight to delevering is what I'd really be focused on.
當我從槓桿的角度考慮槓桿有多高時,我會舉個例子,對於 Antares 收購,我們的槓桿高達 3.3 倍。正如你所提到的,我們能夠去槓桿化,而且現在的去槓桿化程度還不到兩倍,因此我們能夠去槓桿化的情況才是我真正關注的重點。
Vikram Purohit - Analyst
Vikram Purohit - Analyst
Understood. Thank you.
明白了。謝謝。
Operator
Operator
Joe Cantie Zorro, Piper Sandler. Joe, you might be on mute.
喬·坎蒂·佐羅,派珀·桑德勒。喬,你可能處於靜音狀態。
Joe Cantie Zorro - Analyst
Joe Cantie Zorro - Analyst
Sorry, can you hear me now?
抱歉,你現在聽得到我說話嗎?
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes, we can.
是的,我們可以。
Joe Cantie Zorro - Analyst
Joe Cantie Zorro - Analyst
Great. Thanks. Sorry about that. Appreciate you taking the question here. I just had a quick one on the recent SaaS Pro, some label expansion into frontline transplant-eligible myeloma. I think the Perseus study did include a maintenance component, but the label does not include maintenance.
偉大的。謝謝。對此感到抱歉。感謝您在這裡提出問題。我剛剛對最近的 SaaS Pro 進行了快速了解,其中一些標籤擴展到了一線移植資格的骨髓瘤。我認為珀爾修斯研究確實包括維護部分,但標籤上不包括維護。
So wondering if you think the exclusion of maintenance could have any impact on the longer-term outlook for the total dollars allot Darzalex franchise and its sort of growth trajectory or whether you were considering in your longer-term assumptions, some maintenance usage? Any help there would be appreciated.
因此,想知道您是否認為排除維護可能會對 Darzalex 特許經營權分配總額及其成長軌蹟的長期前景產生任何影響,或者您是否在長期假設中考慮了一些維護使用?任何幫助將不勝感激。
Helen Torley - President, Chief Executive Officer, Director
Helen Torley - President, Chief Executive Officer, Director
Yes. And it's a good point, Joe, and you don't know when that when we are looking at some Darzalex, we are we're not forecasting on a specific label by label basis. I think what we do is we take a look at what the analyst consensus some is for patients.
是的。這是一個很好的觀點,喬,你不知道當我們在研究一些 Darzalex 時,我們不是在逐個標籤的基礎上進行預測。我認為我們要做的是看看分析師對病人的共識是什麼。
And so IBM's consent was for sales. And so we really look to see that down across all of the indications that we have in the front line. They're obviously making great share gains at the moment last quarter this quarter of close to 10% share gains in the front line. So I look at this is incremental on a trajectory that's already established with all of the frontline indications and uses that they have in place today.
因此,IBM 的同意是為了銷售。因此,我們確實希望在一線的所有跡像中看到這一點。他們顯然在上個季度取得了巨大的份額增長,本季在一線的份額增長了接近 10%。因此,我認為這是在已經建立的軌跡上漸進的,所有前線適應症和用途都已到位。
Jason Butler - Analyst
Jason Butler - Analyst
Okay, great. That's actually really helpful. I appreciate taking the question. Thanks again.
好的,太好了。這實際上非常有幫助。我很高興接受這個問題。再次感謝。
Operator
Operator
Thank you. And we have reached the end of our Q&A session. Ladies and gentlemen, that concludes today's conference call. Thank you all for joining and you may now disconnect.
謝謝。我們的問答環節已經結束。女士們、先生們,今天的電話會議到此結束。感謝大家的加入,現在可以斷開連線了。