Collegium Pharmaceutical Inc (COLL) 2024 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Greetings, and welcome to the Collegium Pharmaceutical third-quarter 2024 earnings conference call. (Operator Instructions) Please note that this conference call is being recorded.

    您好,歡迎參加 Collegium Pharmaceutical 2024 年第三季財報電話會議。(操作員說明)請注意,本次電話會議正在錄音。

  • I will now turn the call over to Danielle Jesse, Director of Investor Relations at Collegium. Please go ahead.

    我現在將把電話轉給 Collegium 投資者關係總監 Danielle Jesse。請繼續。

  • Danielle Jesse - Director, Investor Relations

    Danielle Jesse - Director, Investor Relations

  • Welcome to Collegium Pharmaceuticals third-quarter 2024 earnings conference call. I am joined today by Mike Heffernan, our Interim President and Chief Executive Officer, Founder, and Chairman; Colleen Tupper, our Chief Financial Officer; and Scott Dreyer, our Chief Commercial Officer.

    歡迎參加 Collegium Pharmaceuticals 2024 年第三季財報電話會議。今天,我們的臨時總裁兼執行長、創辦人兼董事長 Mike Heffernan 也加入了我的行列。 Colleen Tupper,我們的財務長;以及我們的首席商務官 Scott Dreyer。

  • Before we begin today's call, we want to remind participants that none of the information presented today is intended to be promotional, and that any forward-looking statements made today are made pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995.

    在我們開始今天的電話會議之前,我們想提醒與會者,今天提供的任何資訊均無意進行促銷,並且今天所做的任何前瞻性陳述均根據 1995 年《私人證券訴訟改革法案》的安全港條款作出。

  • You are cautioned that such forward-looking statements involve risks and uncertainties, including and without limitation, the risks that we may not be able to successfully commercialize our products, that we may incur significant expense in doing so, though we may not prevail in current or future litigation pertaining to our business, risks related to our ability to realize the anticipated benefits, and synergies of the recently completed acquisition of Ironshore.

    請注意,此類前瞻性聲明涉及風險和不確定性,包括但不限於我們可能無法成功將我們的產品商業化的風險,我們可能會為此承擔巨額費用,儘管我們可能無法在當前情況下獲勝。

  • The risk that the businesses will not be integrated successfully and risks related to future opportunities and plans for Ironshore. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission.

    業務無法成功整合的風險以及與 Ironshore 未來機會和計劃相關的風險。本公司的這些風險和其他風險在公司向美國證券交易委員會提交的定期報告中有詳細說明。

  • Our future results may differ materially from our current expectations discussed today. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website at collegiumpharma.com.

    我們未來的結果可能與我們今天討論的當前預期有重大差異。我們的收益新聞稿和本次電話會議將包括對某些非公認會計準則資訊的討論。您可以在我們的公司網站 collegiumpharma.com 上找到我們的收益新聞稿,包括相關的非 GAAP 調整表。

  • I will now turn the call over to our Chairman, Interim President, and CEO, Mike Heffernan.

    我現在將把電話轉給我們的董事長、臨時總裁兼執行長 Mike Heffernan。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Thank you, Danielle. Good afternoon, and thank you, everyone, for joining the call. Today, we will discuss Collegium's record financial performance during the third quarter and provide an update on our business, including the very exciting news that we have successfully completed our CEO search.

    謝謝你,丹妮爾。下午好,謝謝大家加入通話。今天,我們將討論 Collegium 在第三季創紀錄的財務業績,並提供我們業務的最新情況,包括我們已成功完成執行長搜尋的令人興奮的消息。

  • At Collegium, we're focused on building a leading diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. This quarter, we completed the acquisition of Ironshore Therapeutics and its commercial product, Jornay PM, and we're excited to welcome the employees of Ironshore to our team as we embark on our journey of improving the lives of patients in the ADHD community.

    在 Collegium,我們致力於打造一家領先的多元化專業製藥公司,致力於改善患有嚴重疾病的人們的生活。本季度,我們完成了對 Ironshore Therapeutics 及其商業產品 Jornay PM 的收購,我們很高興歡迎 Ironshore 的員工加入我們的團隊,一起踏上改善 ADHD 社區患者生活的旅程。

  • We strive to do good as we do well, and I'd like to recognize the Collegium team for their commitment to our mission and continued dedication to making a positive impact on the communities we serve by driving equitable access to STEM education and advancing the next generation of life science leaders.

    我們努力做好事,做好事,我要感謝 Collegium 團隊對我們使命的承諾,並透過推動公平獲得 STEM 教育和推進下一代教育,持續致力於為我們服務的社區產生積極影響。

  • Our third-quarter and year-to-date results reflect Collegium's strong operational execution. We are on track to deliver on our 2024 financial commitments as updated following the closing of our acquisition of Ironshore. We've made significant progress in successfully integrating Ironshore, and we continue to generate robust operating cash flows to drive significant top- and bottom-line growth, including growing total revenue 17%, with 11% growth in our pain portfolio revenue and adjusted EBITDA growth of 18% on a year-over-year basis in the third quarter.

    我們第三季和年初至今的業績反映了 Collegium 強大的營運執行力。我們預計將兌現完成收購 Ironshore 後更新的 2024 年財務承諾。我們在成功整合 Ironshore 方面取得了重大進展,並且繼續產生強勁的營運現金流,以推動營收和利潤的顯著增長,包括總收入增長 17%,我們的疼痛組合收入和調整後 EBITDA 增長 11%第三季年增18%。

  • The financial strength of our pain business enabled our acquisition of Ironshore and its commercial product, Jornay PM, the central nervous system stimulant for the treatment of attention deficit hyperactivity disorder, or ADHD, and people six years of age and older. Jornay PM is a highly differentiated commercial asset that diversifies our product portfolio beyond pain and has significant revenue and growth potential and exclusivity into the 2030s.

    我們的疼痛業務的財務實力使我們能夠收購 Ironshore 及其商業產品 Jornay PM,這是一種中樞神經系統興奮劑,用於治療注意力不足過動症 (ADHD) 和六歲及以上人群。Jornay PM 是一項高度差異化的商業資產,它使我們的產品組合多樣化,超越痛苦,並在 2030 年代擁有巨大的收入和成長潛力以及排他性。

  • Jornay PM is expected to generate net revenue in excess of $100 million in 2024, expands our commercial presence into ADHD, a large and growing market, and is poised to become the leading growth driver for Collegium. Since closing the Ironshore acquisition in early September and for the balance of the year, we are focused on integrating the Ironshore business while maximizing the pain portfolio and developing the path to maximize growth of Jornay.

    Jornay PM 預計到 2024 年將產生超過 1 億美元的淨收入,將我們的商業業務擴展到 ADHD 這一龐大且不斷增長的市場,並有望成為 Collegium 的主要成長動力。自 9 月初完成對 Ironshore 的收購以來,在今年餘下的時間裡,我們專注於整合 Ironshore 業務,同時最大化痛苦組合,並製定實現 Jornay 增長最大化的道路。

  • We will also continue our business development efforts to identify assets that allow us to build our expertise in a new therapeutic area beyond pain. As we look to close out a strong year, we are confident that we will deliver on our financial commitments and strategic objectives, enabling strong top- and bottom-line growth in 2025 and beyond.

    我們也將繼續我們的業務開發工作,以確定資產,使我們能夠在疼痛以外的新治療領域建立我們的專業知識。在我們期待結束強勁的一年之際,我們有信心兌現我們的財務承諾和策略目標,從而在 2025 年及以後實現強勁的營收和利潤成長。

  • After an extensive search process, we are very excited to welcome Vikram Karnani as our new CEO, Chief Executive Officer and member of our Board, effective on November 12. The Board of Collegium is convinced he is the right leader with the right skills and the expertise and experience to lead Collegium to its next phase of growth.

    經過廣泛的搜尋過程,我們非常高興地歡迎 Vikram Karnani 擔任我們的新任執行長、執行長和董事會成員,該任命將於 11 月 12 日生效。Collegium 董事會相信他是合適的領導者,擁有正確的技能、專業知識和經驗,能夠帶領 Collegium 進入下一階段的發展。

  • Vikram is a proven leader with more than 15 years of experience in the biopharm industry, including holding various leadership positions across commercial, medical affairs, and business development. Most recently, after the acquisition of Horizon by Amgen, he led Amgen's Rare Disease business as Executive Vice President, and President of Global Commercial Operations and Medical Affairs.

    Vikram 是一位久經考驗的領導者,在生物製藥行業擁有超過 15 年的經驗,包括在商業、醫療事務和業務發展領域擔任過各種領導職務。最近,在安進 (Amgen) 收購 Horizo​​​​n 後,他擔任執行副總裁兼全球商業營運和醫療事務總裁,領導安進 (Amgen) 的罕見疾病業務。

  • Prior to that, he held numerous leadership positions at Horizon Therapeutics to its rapid growth phase, spanning many aspects of the business, including leading growth strategy, and establishing and expanding Horizon's presence in the international markets. He demonstrated success in building organizations and maximizing their potential through both organic growth and business development. This makes him the right fit to lead Collegium. With Vikram as our CEO, we are well-positioned for continued success in 2025 and beyond.

    在此之前,他在 Horizo​​n Therapeutics 的快速成長階段擔任過多個領導職務,涉及業務的許多方面,包括領導成長策略以及建立和擴大 Horizo​​n 在國際市場的影響力。他在建立組織並透過有機成長和業務發展最大限度地發揮其潛力方面取得了成功。這使他成為領導 Collegium 的合適人選。Vikram 擔任我們的首席執行官,我們已做好充分準備,在 2025 年及以後繼續取得成功。

  • In the third quarter of 2024, we announced and closed the Ironshore acquisition, which is expected to deliver on all our strategic objectives related to business development. In addition, we also drove strong revenue growth in our pain portfolio. Recent key accomplishments and highlights include: since the acquisition closed in September, we've seen accelerated growth in Jornay PM prescriptions during the back-to-school season.

    2024 年第三季度,我們宣布並完成了對 Ironshore 的收購,預計這將實現我們與業務發展相關的所有策略目標。此外,我們也推動了疼痛產品組合收入的強勁成長。最近的主要成就和亮點包括:自 9 月收購結束以來,我們看到返校季節 Jornay PM 處方的加速成長。

  • Through the first three quarters of 2024, Jornay prescriptions are up 31.2% year over year. We delivered another strong quarter for Belbuca, marked by record revenue of $53.2 million, up 17% year over year and strong prescription growth of 3.5% year over year and 2.6% quarter over quarter. We generated record Xtampza ER revenue of $49.5 million, up 24% year over year.

    截至 2024 年前三季度,Jornay 處方量年增 31.2%。我們為 Belbuca 帶來了另一個強勁的季度,其收入達到創紀錄的 5320 萬美元,同比增長 17%,處方量同比強勁增長 3.5%,環比增長 2.6%。我們的 Xtampza ER 收入達到創紀錄的 4,950 萬美元,年增 24%。

  • We achieved new payer wins for Belbuca and Xtampza ER, which are expected to support revenue growth in 2025. We continued our history of leadership at PAINWeek through the presentation of eight posters highlighting the clinical and population health impact of our differentiated pain portfolio. And we established our presence at key ADHD congresses, including a presentation on Jornay PM at the American Academy of Child and Adolescent Psychiatry 2024 Annual Meeting in the Canadian ADHD Resource Alliance 2024 Conference.

    我們為 Belbuca 和 Xtampza ER 贏得了新的付款人,預計這將支持 2025 年的收入成長。我們透過展示八張海報,強調我們差異化疼痛產品組合對臨床和人口健康的影響,延續了 PAINWeek 的領導歷史。我們在重要的 ADHD 大會上也佔有一席之地,包括 Jornay PM 在美國兒童和青少年精神病學學會 2024 年年會上以及加拿大 ADHD 資源聯盟 2024 年會議上的演講。

  • I will now turn it over to Scott to give a commercial update.

    我現在將其交給斯科特進行商業更新。

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Thanks, Mike. We're pleased to have completed our recent acquisition of Ironshore and are focused on integrating Jornay PM into our portfolio of commercial assets. Jornay PM expands our commercial presence into the large and growing ADHD market and is poised to become our lead growth driver. Jornay PM is highly differentiated as the only stimulant ADHD medication with convenient evening dosing.

    謝謝,麥克。我們很高興最近完成了對 Ironshore 的收購,並致力於將 Jornay PM 整合到我們的商業資產組合中。Jornay PM 將我們的商業業務擴展到龐大且不斷成長的 ADHD 市場,並準備好成為我們的主要成長動力。Jornay PM 是唯一一種夜間給藥方便的興奮劑 ADHD 藥物,具有高度差異化。

  • Jornay PM provides symptom control upon awakening in the morning and throughout the day, limiting the need for short-acting stimulant add-ons. It has flexible dose-dependent duration, enabling treatment to be tailored to the patient's needs. This is important for pediatric adolescent and adult patients because it eliminates the need to dose at school or at work.

    Jornay PM 可在早晨醒來時和全天提供症狀控制,從而減少對短效興奮劑附加劑的需求。它具有靈活的劑量依賴性持續時間,使得治療能夠根據患者的需求進行客製化。這對兒科青少年和成年患者很重要,因為它消除了在學校或工作時服藥的需要。

  • The ADHD market has grown 5% on average over the past four years. And since 2022, Jornay PM has delivered significant double-digit prescription growth. In 2023, total prescriptions for Jornay PM grew 58% compared to 2022 to approximately 490,000.

    過去四年,ADHD 市場平均成長了 5%。自 2022 年以來,Jornay PM 的處方量實現了兩位數的顯著增長。2023 年,Jornay PM 的總處方數較 2022 年增加了 58%,達到約 49 萬個。

  • And through the first three quarters of 2024, Jornay PM prescriptions grew 31.2% year over year. In addition, Jornay PM has a broad and growing prescriber base with 22,600 prescribers in the third quarter, up 25% since the third quarter of 2023. Jornay PM delivered strong prescription growth in the third quarter, up over 30% year over year, and we are seeing an acceleration during the back-to-school season.

    2024 年前三季度,Jornay PM 處方量年增 31.2%。此外,Jornay PM 擁有廣泛且不斷增長的處方者基礎,第三季度擁有 22,600 名處方者,自 2023 年第三季以來增長了 25%。Jornay PM 第三季的處方成長強勁,年成長超過 30%,我們在返校季期間看到了加速成長。

  • Our commercial team successfully navigated through the acquisition transition and took the necessary actions to maximize the opportunity during the back-to-school season. This is a critical time in the ADHD market when demand typically increases and therapy switching occurs because patients currently being treated for ADHD often need a new option to control their symptoms.

    我們的商業團隊成功完成了收購過渡,並採取了必要的行動,在返校季期間最大限度地利用機會。這是 ADHD 市場的關鍵時刻,需求通常會增加,並且會發生治療轉換,因為目前正在接受 ADHD 治療的患者通常需要新的選擇來控制其症狀。

  • Leveraging the opportunity during the back-to-school season, average weekly prescriptions in October were 13,500 compared to 11,400 in July, an increase of 18%. This is an encouraging growth trajectory, and we're focused on continuing this momentum as we work to maximize the potential of Jornay PM.

    利用返校季的機會,10 月的平均每週處方量為 13,500 份,比 7 月的 11,400 份增加了 18%。這是一個令人鼓舞的成長軌跡,我們致力於繼續保持這一勢頭,並努力最大限度地發揮 Jornay PM 的潛力。

  • Prescription performance is in line with our expectations and the brand is on track to generate net revenue in excess of $100 million in 2024. With strong brand fundamentals and clinical differentiation, we see significant opportunity for Jornay PM. We continue to believe it is poised to become Collegium's lead growth driver, complementing our leadership position in responsible pain management, and we're committed to investing in Jornay PM to maximize the potential of this differentiated asset.

    處方業績符合我們的預期,該品牌預計在 2024 年實現超過 1 億美元的淨收入。憑藉強大的品牌基礎和臨床差異化,我們看到了 Jornay PM 的巨大機會。我們仍然相信,它有望成為 Collegium 的主要成長動力,補充我們在負責任的疼痛管理方面的領導地位,並且我們致力於投資 Jornay PM,以最大限度地發揮這一差異化資產的潛力。

  • Areas of focus include ensuring that the ADHD sales force is adequately sized to effectively reach our targeted HCPs and raising awareness of Jornay PM's unique differentiated profile among caregivers and patients to motivate them to ask their HCP about Jornay PM.

    重點領域包括確保 ADHD 銷售團隊的規模足夠大,以有效接觸我們的目標 HCP,並提高護理人員和患者對 Jornay PM 獨特的差異化形象的認識,以激勵他們向 HCP 詢問有關 Jornay PM 的信息。

  • At Collegium, we take pride in being the leader in responsible pain management with a unique and differentiated portfolio of products for the treatment of pain. Belbuca, Xtampza ER, and Nucynta ER collectively command over half of the branded ER market, demonstrating the ongoing strength and reach of our portfolio. The financial strength of Collegium has been fueled by the success of our pain portfolio and our commercial organization will continue to drive momentum and prioritize maximizing our pain products.

    在 Collegium,我們為成為負責任的疼痛管理領域的領導者而感到自豪,擁有獨特且差異化的疼痛治療產品組合。Belbuca、Xtampza ER 和 Nucynta ER 共同佔據了品牌 ER 市場一半以上的份額,證明了我們產品組合的持續實力和影響力。我們的疼痛產品組合的成功增強了 Collegium 的財務實力,我們的商業組織將繼續推動勢頭並優先考慮最大化我們的疼痛產品。

  • Belbuca delivered another strong quarter with total prescriptions up 3.5% year over year, marking the fifth straight quarter of year-over-year prescription growth and driving record quarterly revenue. In addition, we've seen an acceleration in weekly prescriptions over the last few months. We're encouraged by this consistent growth trend, which speaks to the impact that our strong commercial execution is having on the brand and Belbuca's differentiated product profile.

    Belbuca 再次實現強勁的季度表現,總處方量同比增長 3.5%,標誌著處方量連續第五個季度同比增長,並推動創紀錄的季度收入。此外,我們也發現過去幾個月每週處方量有所增加。我們對這種持續成長趨勢感到鼓舞,這表明我們強大的商業執行力對品牌和 Belbuca 的差異化產品形象產生了影響。

  • Xtampza ER prescriptions were stable in the third quarter, in line with our expectations, and Xtampza ER's share of the OxyContin extended-release market achieved an all-time high of 38.1%. Average weekly prescriptions for Xtampza ER in September and October were up 1% compared to the average weekly in July and August, showing some momentum as we enter the fourth quarter.

    第三季 Xtampza ER 處方穩定,符合我們的預期,Xtampza ER 在奧施康定緩釋片市場的佔有率達到 38.1% 的歷史新高。與 7 月和 8 月的平均每週處方量相比,9 月和 10 月 Xtampza ER 的平均每週處方量增加了 1%,在進入第四季度時顯示出一些勢頭。

  • We expect revenue growth for the full year to be driven by improved gross to net, which has fueled the record net revenue in the third quarter. We're committed to educating physicians on Xtampza ER's differentiated label and capitalizing on Xtampza ER's strong access position in commercial and Part D. Our aspiration is to replace OxyContin utilization for appropriate patients due to Xtampza's superior abuse-deterrent properties and labeling.

    我們預計全年營收成長將受到總淨收入改善的推動,這推動了第三季創紀錄的淨收入。我們致力於向醫生宣傳Xtampza ER 的差異化標籤,並利用Xtampza ER 在商業和D 部分方面的強大准入地位。康定的使用。

  • The Nucynta franchise is a key contributor to our portfolio. the positive developments for the franchise, including the authorized generic agreement with Hikma and the six-month pediatric exclusivity extension, along with the execution of our market access strategy, enable us to continue to manage the Nucynta franchise contribution in 2025 and beyond.

    Nucynta 特許經營權是我們產品組合的關鍵貢獻者。該特許經營權的積極發展,包括與Hikma 的授權通用協議和六個月的兒科獨家經營期限延長,以及我們的市場准入策略的執行,使我們能夠在2025 年及以後繼續管理Nucynta 特許經營權的貢獻。

  • We're committed to growing pain franchise revenue in 2025 and beyond through a combination of driving demand for our highly differentiated products and enhancing the profitability of each brand. In support of that goal, our contracting strategy is clear: achieve broad coverage for our products while delivering on our commitment to enhance profitability of our brands by managing gross to nets.

    我們致力於透過推動對我們高度差異化產品的需求和提高每個品牌的盈利能力,在 2025 年及以後增加疼痛特許經營收入。為了支持這一目標,我們的承包策略很明確:實現我們產品的廣泛覆蓋,同時履行我們透過管理毛淨值來提高品牌獲利能力的承諾。

  • We're pleased to share that Belbuca and Xtampza ER were both added to formulary for a large integrated health system that represents approximately 8 million commercial lives and 2 million Part D lives. We expect revenue growth from this expansion of coverage. However, because this system purchases directly and does not report prescriptions, we won't see the corresponding prescription volume in IQVIA data.

    我們很高興地告訴大家,Belbuca 和 Xtampza ER 都已被添加到代表約 800 萬商業生命和 200 萬 D 部分生命的大型綜合健康系統的處方中。我們預計收入會因覆蓋範圍的擴大而成長。但是,由於該系統直接購買且不報告處方,因此我們不會在 IQVIA 數據中看到相應的處方量。

  • In addition, and consistent with our focus on enhanced profitability, one Medicare Part D plan representing 8 million covered lives will be removing with Xtampza ER and Belbuca from formulary effective January 1. Xtampza ER will be a parity with OxyContin within this plan as both products are off formulary.

    此外,與我們對提高盈利能力的關注相一致,一項代表 800 萬受保人的 Medicare D 部分計劃將從 1 月 1 日起與 Xtampza ER 和 Belbuca 一起從處方中刪除。在該計劃中,Xtampza ER 將與奧施康定同等,因為這兩種產品均未列入處方。

  • As a result of this change, we will pay zero rebates for Belbuca and Xtampza within this plan. These formulary removals will pressure prescriptions for both Xtampza and Belbuca in 2025 but are expected to be net revenue positive for both brands as the prescription decline is offset by profitability improvement.

    由於這項變化,我們將在此計劃內為 Belbuca 和 Xtampza 支付零回扣。這些處方藥的刪除將給 Xtampza 和 Belbuca 到 2025 年的處方藥帶來壓力,但預計這兩個品牌的淨收入將為正,因為處方藥的下降被盈利能力的改善所抵消。

  • In closing, I want to thank the commercial team at Collegium for the strong execution and performance they've delivered for both our pain and ADHD businesses. As we finish the year, we're focused on driving momentum in our (inaudible) pain portfolio and maximizing the potential of Jornay PM. We believe we're well-positioned for meaningful growth in 2025 and beyond.

    最後,我要感謝 Collegium 的商業團隊為我們的疼痛和過動症業務提供的強大執行力和績效。當我們結束這一年時,我們的重點是推動我們(聽不清楚)的疼痛產品組合的勢頭,並最大限度地發揮 Jornay PM 的潛力。我們相信,我們已做好充分準備,在 2025 年及以後實現有意義的成長。

  • I'll now hand the call over to Colleen for a discussion of the financials.

    現在我將把電話轉給科琳,討論財務事宜。

  • Colleen Tupper - Chief Financial Officer, Executive Vice President

    Colleen Tupper - Chief Financial Officer, Executive Vice President

  • Thanks, Scott. Good afternoon, everyone. Our third-quarter performance reflects strong revenue growth, impactful business development, significant bottom-line expansion, and robust operating cash flows. Financial highlights for the third quarter include total net product revenues were a record $159.3 million in the third quarter, up 17% year-over-year.

    謝謝,斯科特。大家下午好。我們第三季的業績反映了強勁的營收成長、有影響力的業務發展、顯著的利潤擴張和強勁的營運現金流。第三季的財務亮點包括第三季產品淨收入總額達到創紀錄的 1.593 億美元,年增 17%。

  • In line with our expectations for the third quarter, Jornay revenues were $8 million, which reflects less than one month of commercial sales and the effect of legacy ordering patterns during the ownership transition. The pain portfolio delivered strong performance with record revenue of $151.3 million, up 11% year over year. Belbuca net revenue was a record $53.2 million, up 17% year over year. Xtampza ER net revenue was a record $49.5 million, up 24% year over year and Xtampza ER gross to net was 50.8% in the third quarter.

    與我們對第三季的預期一致,Jornay 的收入為 800 萬美元,這反映了不到一個月的商業銷售以及所有權過渡期間傳統訂購模式的影響。疼痛產品組合表現強勁,營收創紀錄達到 1.513 億美元,較去年同期成長 11%。Belbuca 淨收入達到創紀錄的 5,320 萬美元,年增 17%。Xtampza ER 淨收入達到創紀錄的 4,950 萬美元,年增 24%,第三季 Xtampza ER 毛淨比為 50.8%。

  • The third quarter did benefit from a one-time favorable managed care rebate adjustment resulting from a formulary review. With this benefit factored in, we now expect full-year Xtampza ER gross to net to be approximately 55% in 2024, which is the low end of the range we previously communicated.

    第三季確實受益於處方審查​​產生的一次性有利的管理式醫療回扣調整。考慮到這一收益,我們現在預計 2024 年全年 Xtampza ER 總淨值約為 55%,這是我們之前溝通的範圍的低端。

  • Nucynta franchise net revenue was $45.1 million, down 5% year over year. GAAP operating expenses were $62 million, up 76% year over year. This quarter included $19.9 million in acquisition-related expenses associated with the Ironshore acquisition. Adjusted operating expenses, which excludes stock-based compensation and acquisition-related expenses were $34.8 million, up 23% year over year.

    Nucynta 特許經營淨收入為 4,510 萬美元,年減 5%。GAAP 營運費用為 6,200 萬美元,較去年同期成長 76%。本季包括與收購 Ironshore 相關的 1,990 萬美元收購相關費用。調整後營運費用(不包括股票薪酬和收購相關費用)為 3,480 萬美元,年增 23%。

  • GAAP net income for the third quarter was $9.3 million, down 55% year over year. Non-GAAP adjusted EBITDA was a record $105.1 million, up 18% year over year. GAAP earnings per share was $0.29 basic and $0.27 diluted in the third quarter compared to GAAP earnings per share of $0.61 basic and $0.53 diluted in the prior year period.

    第三季 GAAP 淨利為 930 萬美元,年減 55%。非 GAAP 調整後 EBITDA 達到創紀錄的 1.051 億美元,年增 18%。第三季 GAAP 基本每股收益為 0.29 美元,稀釋後每股收益為 0.27 美元,去年同期 GAAP 基本每股收益為 0.61 美元,稀釋後每股收益為 0.53 美元。

  • Non-GAAP adjusted earnings per share was $1.61 in the third quarter, up 20% year over year. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. As of September 30, 2024, we have $120 million in cash, cash equivalents, and marketable securities.

    第三季非 GAAP 調整後每股收益為 1.61 美元,較去年同期成長 20%。請參閱我們今天稍早發布的新聞稿,以了解 GAAP 與非 GAAP 業績的調整。截至 2024 年 9 月 30 日,我們擁有 1.2 億美元的現金、現金等價物和有價證券。

  • We generated another quarter of strong operating cash flows, enabling us to execute our capital deployment strategy and complete the acquisition of Ironshore, which utilized approximately $200 million of cash on hand. We are reaffirming our 2024 financial guidance, which we updated following the close of the Ironshore acquisition.

    我們又創造了一個季度強勁的營運現金流,使我們能夠執行我們的資本部署策略並完成對 Ironshore 的收購,該收購利用了大約 2 億美元的手頭現金。我們重申我們的 2024 年財務指引,我們在 Ironshore 收購結束後更新了該指引。

  • We expect net product revenues in the range of $620 million to $635 million. Belbuca revenue growth is primarily fueled by full-year prescription growth, while revenue growth for Xtampza ER is driven by gross to net improvement. 2024 full-year pro forma Jornay PM net revenue is expected to be in excess of $100 million.

    我們預計產品淨收入在 6.2 億至 6.35 億美元之間。Belbuca 收入成長主要由全年處方成長推動,而 Xtampza ER 收入成長則由總淨值改善推動。預計 2024 年全年 Jornay PM 淨收入將超過 1 億美元。

  • For the Nucynta franchise on a full-year basis due to the elimination of the Medicaid cap by the American Recovery Act, we expect some pressure on the Nucynta franchise year-over-year revenues in 2024 with a return to relative year-over-year stability in 2025.

    對於 Nucynta 特許經營權而言,由於《美國復甦法案》取消了醫療補助上限,我們預計 2024 年 Nucynta 特許經營權的同比收入將面臨一些壓力,將恢復到相對同比水平2025年穩定。

  • We expect adjusting operating expenses in the range of $150 million to $155 million and adjusted EBITDA in the range of $395 million to $405 million. With our strong financial performance thus far, we are well-positioned to deliver on our financial commitments for 2024. We remain focused on our capital deployment strategy to create long-term value for our shareholders by executing on business development through the integration of Jornay PM, paying down debt and opportunistically repurchasing shares.

    我們預計調整後的營運費用將在 1.5 億至 1.55 億美元之間,調整後的 EBITDA 將在 3.95 億至 4.05 億美元之間。憑藉迄今為止強勁的財務業績,我們完全有能力兌現 2024 年的財務承諾。我們仍然專注於我們的資本部署策略,透過整合 Jornay PM、償還債務和機會性回購股票來執行業務發展,為股東創造長期價值。

  • We have a proven track record of successful business development, including the acquisitions of the Nucynta franchise and Belbuca, and we will leverage this expertise to efficiently integrate and maximize the potential of Jornay PM. We are already seeing immediate accretion with the addition of Jornay PM and expect the product to be accretive to adjusted EBITDA in 2025.

    我們擁有成功的業務發展記錄,包括收購 Nucynta 特許經營權和 Belbuca,我們將利用這些專業知識來有效整合並最大限度地發揮 Jornay PM 的潛力。我們已經看到,隨著 Jornay PM 的加入,該產品將立即增加,並預計產品將在 2025 年增加調整後的 EBITDA。

  • We're committed to investing in the continued growth of Jornay PM as we look to build a new therapeutic area of focus beyond pain. We are also focused on managing our debt. With the Ironshore acquisition, we secured a $646 million new term loan from Pharmakon. $320.8 million of the new term loan was used to replace our prior loan with Pharmakon, reducing our interest rate on this balance by 300 basis points. In addition to the significant improvement in our cost of capital, the new loan also has a longer-term lower amortization and more prepayment flexibility.

    我們致力於投資 Jornay PM 的持續成長,因為我們希望建立一個超越疼痛的新治療重點領域。我們也專注於管理我們的債務。透過收購 Ironshore,我們從 Pharmakon 獲得了 6.46 億美元的新定期貸款。新定期貸款中的 3.208 億美元用於取代我們先前向 Pharmakon 提供的貸款,使我們的餘額利率降低了 300 個基點。除了我們的資金成本顯著改善外,新貸款還具有長期較低的攤提和更大的提前還款彈性。

  • We estimate that our net leverage at year-end will be less than 2 times net EBITDA based -- sorry, less than 2 times based on estimated fiscal year 2024 combined EBITDA. In addition, we have $115 million remaining in the $150 million share repurchase program approved by our Board earlier this year. We are confident in the strength of our business and the value it will continue to generate and will opportunistically leverage share repurchases to return value to shareholders.

    我們預計年底的淨槓桿率將低於基於 EBITDA 淨值的 2 倍——抱歉,低於基於 2024 財年預計合併 EBITDA 的 2 倍。此外,董事會今年稍早批准的 1.5 億美元股票回購計畫還剩 1.15 億美元。我們對我們的業務實力及其將繼續產生的價值充滿信心,並將機會主義地利用股票回購為股東回報價值。

  • Looking forward to 2025 and beyond, we will continue to leverage the momentum and financial strength of our core pain business to deliver on our financial commitments of growing revenue, increasing profitability, and generating robust cash flows. The outlook of our pain business is bolstered by the recent positive developments for our pain portfolio, the Nucynta franchise authorized generic agreement with Hikma, and the pediatric exclusivity extension, along with our successful payer strategy and tailwinds from the Medicare Part D redesign, are expected to drive organic growth in 2025.

    展望2025年及以後,我們將繼續利用核心疼痛業務的勢頭和財務實力,兌現我們增加收入、提高盈利能力和產生強勁現金流的財務承諾。我們的疼痛業務的前景受到近期疼痛產品組合的積極發展、與Hikma 的Nucynta 特許經營授權通用協議、兒科獨家經營擴展、以及我們成功的付款人策略和Medicare D 部分重新設計帶來的推動力的推動。

  • At the same time, we are focused on integrating and maximizing the value of Jornay PM and investing in its future growth. Jornay PM is poised to be our lead growth driver as we build on the positive momentum we are already seeing just a month into owning the product. We remain dedicated to the disciplined execution of our capital deployment strategy as we look to expand our portfolio of commercial products, pay down debt, and opportunistically return value to shareholders through share repurchases.

    同時,我們專注於整合和最大化Jornay PM的價值,並投資於其未來的成長。Jornay PM 有望成為我們的主要成長動力,因為我們在擁有該產品僅一個月後就已經看到的積極勢頭基礎上繼續發展。我們仍然致力於嚴格執行我們的資本部署策略,因為我們希望擴大我們的商業產品組合,償還債務,並透過股票回購機會主義地向股東回報價值。

  • I will now turn the call back to Mike.

    我現在將把電話轉回給麥克。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Thanks, Colleen. We are proud of our accomplishments in the third quarter, which positioned us for continued success in 2025. For the remainder of the year, we are focused on integrating and maximizing Jornay PM in addition to delivering on the financial and strategic commitments of the core pain business.

    謝謝,科琳。我們對第三季的成就感到自豪,這為我們在 2025 年繼續取得成功奠定了基礎。在今年剩下的時間裡,除了兌現核心疼痛業務的財務和策略承諾外,我們還將重點關注 Jornay PM 的整合和最大化。

  • We are confident in our ability to deliver record financial results, generate robust cash flows, and deploy capital in a disciplined manner. I'd like to personally thank the Collegium leadership team for their exceptional stewardship through the transformational Ironshore acquisition, and we're very excited to welcome Vikram as our new CEO this month to join our strong team.

    我們對實現創紀錄的財務業績、產生強勁的現金流並以嚴格的方式部署資本的能力充滿信心。我個人要感謝 Collegium 領導團隊在收購 Ironshore 的過程中所表現出的卓越管理能力,我們非常高興地歡迎 Vikram 本月作為我們的新任首席執行官加入我們強大的團隊。

  • With his extensive commercial and business development experience, I am confident he is the right person to lead Collegium through this next phase of growth. I will now open the call up for questions. Operator?

    憑藉他豐富的商業和業務開發經驗,我相信他是領導 Collegium 下一階段發展的合適人選。我現在將開始提問。操作員?

  • Operator

    Operator

  • (Operator Instructions) Les Sulewski, Truist Securities.

    (操作員指示)Les Sulewski,Truist Securities。

  • Leszek Sulewski - Analyst

    Leszek Sulewski - Analyst

  • I have a few, maybe first for Mike or Colleen. Congrats on the impressive CEO selection. And although it might be premature, but given Vikram's strong rare disease background, would you expect any divergence in BD plans into new therapeutic areas? Or do you essentially expect to continue to anchor around the new neuro category.

    我有一些,也許首先是給麥克或科琳的。祝賀令人印象深刻的執行長選擇。儘管這可能為時過早,但考慮到 Vikram 強大的罕見疾病背景,您是否認為 BD 計劃會出現新的治療領域的分歧?或者你本質上期望繼續圍繞新的神經類別進行錨定。

  • And then maybe for Scott, what are the plans for Belbuca and your investment efforts leading into LOE? And then what is the value proposition of Belbuca against some of the other chronic pain products, specifically those undergoing clinical trials such as [Centogene]?

    那麼對於 Scott 來說,Belbuca 的計劃以及您對 LOE 的投資努力是什麼?那麼 Belbuca 相對於其他一些慢性疼痛產品的價值主張是什麼,特別是那些正在進行臨床試驗的產品,例如[Centogen]?

  • And then maybe last, can you talk about the back-to-school season with Jornay, how much of that script growth was tied to the ownership change? And what do you, I guess, envision the peak sales potential or peak market share potential from Jornay across the ADHD market? And then in general, can you highlight how impactful is the back-to-school season seasonality to this product? Sorry for the mouthful, but thank you.

    最後,你能談談喬奈的返校季嗎?我想,您對 Jornay 在 ADHD 市場上的峰值銷售潛力或峰值市場份額潛力有何看法?總的來說,您能否強調一下返校季季節性對該產品的影響有多大?抱歉說太多了,不過還是謝謝你。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Thank you, Les, for the question. This is Mike. I'll start at the beginning, and then I'll ask Scott to jump in on some of the other questions. As it relates to our strategy, since we closed the Ironshore acquisition in early September, and as I mentioned in the -- for the balance of the year, we're really focused on integrating Jornay and growing Jornay as well as maximizing our pain portfolio.

    謝謝萊斯的提問。這是麥克。我將從頭開始,然後我會請斯科特回答其他一些問題。因為它與我們的策略相關,自從我們在 9 月初完成了對 Ironshore 的收購,正如我在今年剩餘的時間裡提到的,我們真正專注於整合 Jornay 和發展 Jornay 以及最大化我們的疼痛產品組合。

  • So that is a key part of our strategy. We'll also continue our business development efforts to identify assets that allow us to build our expertise in a new therapeutic area beyond pain. As Vikram gets further acquainted with the business, he'll work with both our leadership team as well as the Board to further build out Collegium's strategy and execution and further put a fine point on the business development strategy.

    所以這是我們策略的關鍵部分。我們也將繼續我們的業務開發工作,以確定資產,使我們能夠在疼痛以外的新治療領域建立我們的專業知識。隨著 Vikram 對業務的進一步了解,他將與我們的領導團隊和董事會合作,進一步製定 Collegium 的策略和執行力,並進一步明確業務發展策略。

  • I'll pass it to Scott for the question of Belbuca LOE.

    我將把 Belbuca LOE 的問題轉給 Scott。

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Got it. All right, Les. So starting with Belbuca LOE, Look, the biggest thing I'd say there is we are investing through the tape. So we don't view Belbuca as an asset where we're in harvest mode. The fact of the matter is -- you look at the current LOE assumptions, we think there may be some upside there, so we're investing fully in the product.

    知道了。好吧,萊斯。因此,從 Belbuca LOE 開始,看,我想說的最重要的事情是我們正在透過磁帶進行投資。因此,我們不認為貝爾布卡是我們處於收穫模式的資產。事實是——你看看目前的 LOE 假設,我們認為那裡可能有一些好處,所以我們正在全力投資該產品。

  • To your question about competition and the Vertex product, first, I'd just say any new product in pain, we're a fan of. As the leader of responsible pain management, we believe in options that come to the market that are helpful for patients. That said, that product has no competition in the chronic pain place where all of our products play not just Belbuca.

    對於你關於競爭和 Vertex 產品的問題,首先,我只想說任何痛苦的新產品,我們都是它的粉絲。作為負責任的疼痛管理的領導者,我們相信市場上的選擇對病人有幫助。也就是說,該產品在慢性疼痛領域沒有競爭,我們所有的產品都在發揮作用,而不僅僅是貝爾布卡。

  • So don't view it in any way competitive and think Belbuca has a runway -- a long runway of growth as the use of buprenorphine in pain continues to increase, the buprenorphine market is growing and Belbuca is highly differentiated within the market.

    因此,不要以任何方式認為它具有競爭力,並認為Belbuca 有一條跑道——一條漫長的增長跑道,因為丁丙諾啡在疼痛中的使用不斷增加,丁丙諾啡市場正在增長,而且Belbuca 在市場中具有高度差異化。

  • On back-to-school, which you asked about Jornay, look, we're really happy with what's happened during the back-to-school season. So we closed the deal kind of in the middle of the season, the season kicks in, in the August time period. And the team has done a tremendous job focusing on execution. We've seen -- if you look at the average weeklies, we've seen 18% growth comparing October versus July.

    關於返校,你問到了喬妮的情況,聽著,我們對返校季節發生的事情感到非常滿意。因此,我們在賽季中期、賽季開始、八月期間完成了交易。該團隊在執行方面做了大量工作。我們已經看到,如果您查看平均週數,我們會發現 10 月與 7 月相比增長了 18%。

  • We expect that momentum to continue as the season typically has an impact that carries into November and think it's just going to set us on a great trajectory as we enter 2025. You asked about peak sales, and we don't give peak sales items, so we're not going to give any more color on that. I'll just reinforce the growth trajectory of Jornay is very strong, and we expect that to continue as we go into next year.

    我們預計這種勢頭將持續下去,因為這個季節的影響通常會持續到 11 月,並認為這將使我們在進入 2025 年時走上良好的軌道。您詢問了峰值銷售情況,而我們沒有提供峰值銷售商品,因此我們不會對此進行更多說明。我只想強調 Jornay 的成長軌跡非常強勁,我們預計這種情況將在明年繼續下去。

  • Leszek Sulewski - Analyst

    Leszek Sulewski - Analyst

  • Excellent. Thank you for that color.

    出色的。謝謝你的那個顏色。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    大衛·阿姆塞勒姆,派珀·桑德勒。

  • David Amsellem - Analyst

    David Amsellem - Analyst

  • So on Jornay PM, can you remind us how you're thinking about the gross to net spread going forward, whether you can give us a range or just give us some sense of what the gross to net looks like in relation to other branded agents for ADHD? That would be helpful. That's number one.

    那麼,Jornay PM,您能否提醒我們您如何考慮未來的毛淨利差,您是否可以給我們一個範圍,或者只是讓我們了解與其他品牌代理商相比的毛淨利差情況對於多動症?那會有幫助的。這是第一名。

  • And then number two, just coming back to business development and M&A. So with Jornay, you've got sort of an interesting and somewhat diverse call audience. I believe there's pediatricians, general practitioners, psychiatrists who are prescribing the product. So given that call audience and the commercial infrastructure you have, how does that inform how you're thinking about future business development M&A? Thanks.

    然後是第二點,回到業務開發併購。因此,對於 Jornay,您會遇到一些有趣且多樣化的電話受眾。我相信有兒科醫生、全科醫生、精神科醫生在開這個產品的處方。那麼,考慮到電話受眾和您擁有的商業基礎設施,這對您如何考慮未來的業務發展併購有何影響?謝謝。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Great. Thanks, David. Scott, do you want to take the first question on Jornay PM and gross to net?

    偉大的。謝謝,大衛。Scott,你想回答關於 Jornay PM 和gross to net 的第一個問題嗎?

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Yes, sure. So Colleen and I will tag team on this one. First, I'll just start with coverage and reinforce that when you look at coverage for the brand, it's very strong right now. 60% of the businesses is in commercial, 40% is in Medicaid, and Jornay has coverage across 80% of that overall.

    是的,當然。所以科琳和我將在這個專案上標記團隊。首先,我將從覆蓋範圍開始,並強調,當您查看該品牌的覆蓋範圍時,它現在非常強大。 60% 的企業屬於商業企業,40% 屬於醫療補助企業,Jornay 的覆蓋率佔整體企業的 80%。

  • So what that means is we're happy with the coverage. We will always look to expand coverage. But as we've done on the pain side, we'll be disciplined in terms of choices we make to expand that coverage.

    這意味著我們對報道感到滿意。我們將始終尋求擴大覆蓋範圍。但正如我們在痛苦方面所做的那樣,我們將在擴大覆蓋範圍的選擇方面受到約束。

  • Colleen, you want to give a little more color on gross to net?

    科琳,你想為淨值提供更多的顏色嗎?

  • Colleen Tupper - Chief Financial Officer, Executive Vice President

    Colleen Tupper - Chief Financial Officer, Executive Vice President

  • Yes. I'd say, David, we look forward in early January to give you a bit more color on guidance. But what we're seeing for gross to net on Jornay is typical what you would see in branded ADHD products. It's sitting in the 60s range. You have, obviously, rebates making up a big portion of that and also the [co-pay] program, which is typical in this space.

    是的。我想說,大衛,我們期待在一月初為您提供更多指導。但我們在 Jornay 上看到的毛淨值是你在品牌 ADHD 產品中看到的典型情況。它位於 60 年代範圍內。顯然,回扣佔其中很大一部分,還有[共同支付]計劃,這在這個領域很常見。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • And then on the other question on BD, as you know, our focus has really been moving beyond pain. And as you suggested, Jornay PM and our call points give us a lot of flexibility to go in a number of different directions. I mean, clearly, we'd like to leverage our new commercial expertise and overlap.

    關於 BD 的另一個問題,如您所知,我們的重點實際上已經超越了疼痛。正如您所建議的,Jornay PM 和我們的呼叫點為我們提供了極大的靈活性,可以朝著許多不同的方向發展。我的意思是,顯然,我們希望利用我們新的商業專業知識和重疊。

  • And again, because of the call points, I think it gives us a lot of optionality. We will primarily spend our time integrating Jornay and thinking about a lot about how to grow it. And then as Vikram comes in and we analyze the opportunities that are in front of us, we will, as we move into next year, I'm sure -- move our development strategy forward such that we will be looking to really leverage a new expertise beyond pain.

    再說一次,由於呼叫點,我認為它給了我們很多選擇。我們將主要花時間整合 Jornay 並思考如何發展它。然後,當維克拉姆進來時,我們分析了擺在我們面前的機會,我確信,當我們進入明年時,我們將向前推進我們的發展戰略,這樣我們將尋求真正利用一個新的機會。痛苦的專業知識。

  • Operator

    Operator

  • Serge Belanger, Needham & Company.

    謝爾蓋貝蘭格 (Serge Belanger),李約瑟公司。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • A couple of questions for us. I guess the first one, regarding the ongoing integration of Jornay PM. Scott, I think you talked about sales force sizing for that products. Just curious what the current size of the sales force is and how you're thinking about the modifications to that?

    有幾個問題想問我們。我猜第一個是關於 Jornay PM 的持續整合。斯科特,我想您談到了該產品的銷售人員規模。只是好奇目前銷售隊伍的規模是多少以及您如何考慮對其進行修改?

  • And then secondly, regarding the changes to formulary coverage on both Xtampza and Belbuca. I think there were two pieces -- so first, on -- where you're losing exclusivity. Just curious how many prescriptions are at risk here? And on the new plant, is there an existing [Oxy] business that allows you -- that provides a conversion opportunity for that new formulary? Yeah, that's it. Thanks.

    其次,關於 Xtampza 和 Belbuca 處方覆蓋範圍的變化。我認為有兩件事——首先是——你失去了排他性。只是好奇這裡有多少處方存在風險?在新工廠中,是否有現有的 [Oxy] 業務可以為新處方提供轉換機會?是的,就是這樣。謝謝。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Great. Thanks, Serge. Scott, it sounds like these are both for you, on the integration for --

    偉大的。謝謝,塞爾吉。斯科特,聽起來這些都適合你,關於集成--

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Sounds good. Yes. So Serge, first, when it comes to the sales force and our current situation. So currently, we have about 150 salespeople all in. That's reps and management. And we're doing the work right now to assess where we go from here. We believe that we need to expand a bit to get the coverage we want.

    聽起來不錯。是的。首先,Serge 談到銷售團隊和我們目前的狀況。目前,我們約有 150 名銷售人員。這就是代表和管理層。我們現在正在進行工作來評估我們未來的發展方向。我們認為,我們需要擴大一點才能獲得我們想要的覆蓋範圍。

  • And look, our focal point is around maximizing the potential and raising awareness. And that means we're looking at where prescribing happens and ensuring that we have enough coverage to get the recent frequency that's needed to continue to accelerate the growth of the brand. And so, when we get to January on our OpEx guidance, that will all include any final choices we make on the sales force.

    看,我們的重點是最大限度地發揮潛力和提高意識。這意味著我們正在關注處方發生的地方,並確保我們有足夠的覆蓋範圍以獲得繼續加速品牌成長所需的近期頻率。因此,當我們一月份發布營運支出指南時,這將包括我們對銷售人員所做的任何最終選擇。

  • To your second question about the formulary changes, so we'll take them one by one. In terms of the addition, 8 million lives in commercial, 2 million lives in Part D at the integrated health system that I mentioned. Right now, there's a little bit of OxyContin business in there, but not much. So it's a little bit different than the conversion opportunities we've had in the past and more of a starting with fresh coverage when it comes to OxyContin.

    關於你提到的第二個問題,關於處方的變化,我們將一一回答。就補充而言,800 萬人生活在商業中,200 萬人生活在我提到的綜合健康系統的 D 部分。目前,那裡有一點奧施康定業務,但不多。因此,這與我們過去的轉換機會有點不同,更多的是從奧施康定的新報道開始。

  • When it comes to Belbuca, there is some use but a lot of opportunity in front of us in the plan. In terms of scripts, you said where we were removed from formulary at the Part D plan that I mentioned with 8 million lives, so that's in that plan. It's about 12% of Belbuca prescriptions. It's about 18% of Xtampza prescriptions that sit within that plan.

    說到貝爾布卡,我們的計畫中有一些用處,但也有很多機會。就腳本而言,您提到我們在 D 部分計劃中被從處方中刪除的地方,我提到了 800 萬條生命,所以這也在該計劃中。約佔 Belbuca 處方的 12%。大約 18% 的 Xtampza 處方屬於該計劃。

  • And as a reminder, it's an opportunity where we were not willing to pay what it would take to keep that access, and the rebate will go to zero. And so, we are confident that it will be net revenue positive overall while seeing the pressure on prescriptions in those plants. Hopefully, that helps, Serge.

    提醒一下,這是一個機會,我們不願意支付保留該訪問權限所需的費用,並且回扣將為零。因此,我們有信心在看到這些工廠處方壓力的同時,整體淨收入將為正。希望這會有所幫助,Serge。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • Yes. So when you combine the two changes with the new addition and the change to the existing formulary, do you think it will be a wash in terms of decision volume for both Xtampza and Belbuca?

    是的。因此,當您將這兩個變更與新增內容和現有處方集的變更結合時,您認為 Xtampza 和 Belbuca 的決策會減少嗎?

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Yes. So it's a wash in terms of lives, not in terms of prescriptions because as I mentioned, to the integrated health system, they don't have prescriptions reported through IQVIA. So we'll have revenue that comes through, but you will see no prescriptions; whereas where the removals happen, that is directly IQVIA-impacted scripts.

    是的。因此,這是對生命的洗禮,而不是對處方的洗禮,因為正如我所提到的,對於綜合健康系統來說,他們沒有通過 IQVIA 報告的處方。所以我們會有收入,但你不會看到任何處方;而發生刪除的地方,則是直接受 IQVIA 影響的腳本。

  • So that will, again, all be factored in when we give our revenue guidance in January, as we always do, all those ins and outs will be there. But what's important is the revenue will be different in terms of scripts in those two different situations, if that makes sense.

    因此,當我們一月份給出收入指導時,所有這些都會被考慮在內,就像我們一貫所做的那樣,所有這些細節都會在那裡。但重要的是,如果這有意義的話,在這兩種不同情況下,劇本的收入將會有所不同。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • Yes. Thanks for the color.

    是的。謝謝你的顏色。

  • Operator

    Operator

  • Oren Livnat, H.C. Wainright.

    奧倫·利夫納特,H.C.溫賴特。

  • Oren Livnat Livnat - Analyst

    Oren Livnat Livnat - Analyst

  • Thanks, I have a couple. Just to follow up on the questions regarding Vikram's appointment as CEO. Can you just talk about what made him a good fit given his experience in global rare disease versus your portfolio of mass market, ADHD and pain products?

    謝謝,我有幾個。只是為了跟進有關維克拉姆被任命為首席執行官的問題。鑑於他在全球罕見疾病方面的經驗與您的大眾市場、過動症和疼痛產品組合相比,您能否談談是什麼讓他非常適合?

  • Should we take it to -- should I assume that your existing core management competencies on that front will maybe be elevated, and he will be more focused on broadening your horizons into other areas? Or is he excited and prepared to take on maybe a different sort of book of business? And I have a follow-up, so I'll wait.

    我們是否應該假設您在這方面現有的核心管理能力可能會得到提升,並且他會更專注於將您的視野拓寬到其他領域?或者他感到興奮並準備好接受一本不同類型的商業書籍?我還有後續行動,所以我會等待。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Thank you, Oren. Yes, let me talk a little bit about Vikram's experience. As I mentioned, he's been in the biopharma for over 15 years. But he was involved in every aspect of the Horizon business as the business grew from $300 million in revenue to $4 billion and as we know, resulted in a $28 billion acquisition by Amgen. He successfully led the transformation of the company, it's commercial growth, the building of its international division.

    謝謝你,奧倫。是的,讓我談談維克拉姆的經歷。正如我所提到的,他在生物製藥領域工作了 15 年多。但隨著 Horizo​​n 業務的收入從 3 億美元增長到 40 億美元,他參與了 Horizo​​​​n 業務的各個方面,正如我們所知,最終被安進以 280 億美元收購。他成功地領導了公司的轉型、商業成長和國際部門的建設。

  • And those skills, regardless of therapeutic expertise, are certainly transferable when it comes to leveraging the growth of Collegium in the next phase of growth. I think Vikram is -- and he'll talk to you about this because he's starting next week, but I think he's pretty excited about the base business that we've created at Collegium.

    而且,無論治療專業知識如何,這些技能在利用 Collegium 下一階段的增長時肯定是可以轉移的。我認為 Vikram 是——他會和你談論這個,因為他下週就要開始工作,但我認為他對我們在 Collegium 創建的基礎業務感到非常興奮。

  • It gives him a great substrate to build upon with a very strong business and a very strong management team. And so, for any new CEO coming into a situation, he's got really the opportunity to already have a growth business and then take his expertise, which is in addition to the expertise we already have and build on the growth. So we're really excited about having him join the company.

    這為他建立強大的業務和強大的管理團隊提供了良好的基礎。因此,對於任何進入這種情況的新執行長來說,他確實有機會擁有一個成長型業務,然後利用他的專業知識,這是我們已經擁有的專業知識的補充,並在成長的基礎上繼續發展。因此,我們對他加入公司感到非常興奮。

  • Oren Livnat Livnat - Analyst

    Oren Livnat Livnat - Analyst

  • Got it. And on Jornay PM, you highlighted the pretty strong execution through back-to-school, but I can't imagine there wasn't some friction or disruption with the corporate change and yet it looks like you're delivering. Look, I think about 25% year-over-year growth right now. Is it fair to say that you're not firing necessarily on all cylinders during that transition, maybe growth could actually inflect upwards again, even on a year-over-year basis with both settling in the organization, rightsizing, and some increased resource allocation?

    知道了。在 Jornay PM 上,您強調了返校期間相當強大的執行力,但我無法想像公司變革中沒有出現一些摩擦或中斷,但看起來您正在交付。看,我認為現在的同比增長約為 25%。公平地說,在轉型過程中,你不一定會全力以赴,也許成長實際上可能會再次向上,即使是在逐年的基礎上,隨著組織的調整、規模的調整和一些資源分配的增加?

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Yes. Thanks, Oren. Scott, do you want to take that?

    是的。謝謝,奧倫。史考特,你想接受這個嗎?

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Yes, that's great. Yes. Oren, great question. So first, I'd say really, we didn't see disruption, and that was purposeful because as you may recall, we kept the entire sales force management team and everybody intact to ensure continuity. So to the first question, yes, firing on all cylinders, year-over-year growth is actually up 31.2% and that accelerated during back-to-school season, frankly, at a greater rate than they accelerated last year during back-to-school season.

    是的,那太好了。是的。奧倫,好問題。首先,我想說的是,我們沒有看到中斷,這是有目的的,因為您可能還記得,我們​​保持了整個銷售團隊管理團隊和每個人的完整,以確保連續性。所以對於第一個問題,是的,全速前進,同比增長實際上增長了 31.2%,並且在返校季節加速了,坦率地說,比去年返校期間加速的速度更快。

  • So the team needs a tremendous amount of credit for that continuity during that time. Now to your question going forward, of course, there's future opportunity. And I put it into a couple of buckets. First, forward execution, right? We will bring our expertise to ensure that we're executing on all cylinders in front of the customer. That's number one.

    因此,團隊需要大量的信任來確保這段時間內的連續性。現在回答你的問題,當然,未來還有機會。我把它放進幾個桶子裡。首先,向前執行,對嗎?我們將利用我們的專業知識來確保我們在客戶面前全力執行。這是第一名。

  • Number two, as I mentioned in my prepared remarks, we'll ensure that we're adequately sized and investing from a marketing standpoint to drive awareness and uptake among HCPs first. And then number three, if you think about the profile I laid out of this product, clearly, it's a product that if you're a caregiver and understand that there's a product for ADHD that you could dose once in the evening and that could carry you through your trial through the next day from upon awakening all the way through the day, that's a pretty interesting product for caregivers and for patients, and the awareness there is very low.

    第二,正如我在準備好的演講中提到的,我們將確保我們有足夠的規模並從行銷的角度進行投資,以首先提高 HCP 的認知度和採用率。第三,如果你考慮一下我對這款產品的介紹,很明顯,如果你是一名護理人員並且了解有一種治療多動症的產品,你可以在晚上服用一次,並且可以攜帶從醒來開始一直到第二天,這對護理人員和患者來說是一個非常有趣的產品,但人們的認知度非常低。

  • So we will take action and make investments to take advantage of that opportunity. So those are the things we'll be focused on as we move through 2025 to continue the growth momentum of the brand.

    因此,我們將採取行動並進行投資,以利用這個機會。因此,這些是我們在 2025 年繼續保持品牌成長勢頭時將重點關注的事情。

  • Oren Livnat Livnat - Analyst

    Oren Livnat Livnat - Analyst

  • All right. And on Jornay in the market, it's obviously a highly genericized overall ADHD space. I'm not sure if I'm mistaken, there's only a couple real unique branded methylphenidate products out there, and you've got Azstarys with a prodrug and you guys -- with this pretty unique dosing. Can you talk about your field reception out there with regards to other branded competition and your differentiation and maybe how it seems to be shaking out in terms of patient or physician preference for these two different value propositions?

    好的。而在市場上的 Jornay 上,這顯然是一個高度通用化的整體 ADHD 空間。我不確定我是否弄錯了,市面上只有幾種真正獨特的品牌哌醋甲酯產品,而 Azstarys 帶有前藥,而你們這些傢伙,劑量非常獨特。您能否談談您在其他品牌競爭方面的現場接受情況以及您的差異化,以及患者或醫生對這兩種不同價值主張的偏好似乎如何改變?

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Yes. Scott, do you want to take that?

    是的。史考特,你想接受這個嗎?

  • Scott Dreyer - Executive Vice President, Chief Commercial Officer

    Scott Dreyer - Executive Vice President, Chief Commercial Officer

  • Yes. So a couple of insights I'd give you. One, if you just look at performance in the market, the growth of Jornay in the back-to-school season has exceeded competitive sets. So that's number one. And that includes also [Qelbree], the non-stimulus. So when you look at just the branded marketplace, the reception is really strong and growing.

    是的。我想給你一些見解。第一,如果單看市場表現,喬奈在返校季的成長已經超過了競爭對手。所以這是第一。這也包括[Qelbree],即非刺激措施。因此,當你只看品牌市場時,你會發現反應非常強烈,而且還在持續成長。

  • When you look at physician feedback, what we're hearing is that they truly see the uniqueness not just of the evening dosing, but the fact that the product carries through the next day from morning through the day. So they look at, for instance, in Azstarys, as more of another kind of typical type of extended-release product, like a lot of the extended-release products that have gone generic. But they see Jornay as being truly different.

    當您查看醫生的回饋時,我們聽到的是,他們不僅真正看到了晚上給藥的獨特性,而且還看到了該產品從早上一直持續到第二天的事實。例如,他們將 Azstarys 視為另一種典型類型的緩釋產品,就像許多已經通用的緩釋產品一樣。但他們認為喬妮確實與眾不同。

  • And the best evidence we have of this is when someone switches to Jornay in the early data we're seeing, it's a stickier product. And actually, adherence is a little bit longer on it than other ADHD medications. So that's what we're seeing in the marketplace. The reception is good. The prescriber base, as I shared, is growing up 25% year over year, almost 23,000 physicians in the third quarter.

    我們所掌握的最佳證據是,根據我們看到的早期數據,當有人轉向 Jornay 時,它是一種更具黏性的產品。事實上,它的堅持時間比其他過動症藥物要長一些。這就是我們在市場上看到的情況。接待情況良好。正如我所分享的,處方醫生群體年增 25%,第三季有近 23,000 名醫生。

  • So there's a good receptivity, there's a momentum behind the drug, and we're going to continue to try to continue to keep that going.

    因此,人們對這種藥物有良好的接受度,有動力,我們將繼續努力保持這種勢頭。

  • Oren Livnat Livnat - Analyst

    Oren Livnat Livnat - Analyst

  • And just lastly, one housekeeping thing. I haven't run the math yet with gross to net and this low Xtampza ER numbers, so maybe that lines up perfectly, but were there any material inventory moves on Xtampza or any other product up or down in the quarter?

    最後,一件家事。我還沒有對總淨值和如此低的 Xtampza ER 數字進行數學計算,所以也許這完全符合,但是本季度 Xtampza 或任何其他產品是否有任何材料庫存變動?

  • Colleen Tupper - Chief Financial Officer, Executive Vice President

    Colleen Tupper - Chief Financial Officer, Executive Vice President

  • Oren, across the pain portfolio, it's pretty consistently around [15], plus or minus a half on Jornay, because it was a little bit less than a month that we had ownership, and they had for one of the big three wholesalers, an every-other-week ordering pattern. We have lower days on hand than you typically see. So Jornay ended September, just shy of 11 days on hand, and you would normally expect that to be about [15], but that was the only difference, I'd call.

    Oren,在整個痛苦組合中,它非常一致地在 [15] 左右,在 Jornay 上加或減一半,因為我們擁有所有權的時間不到一個月,而且他們為三大批發商之一擁有所有權,每隔一周的訂購模式。我們手頭上的可用天數比您通常看到的要少。因此,Jornay 於 9 月結束,只剩下不到 11 天的時間,您通常會預計該天數約為 [15],但我認為這是唯一的區別。

  • Oren Livnat Livnat - Analyst

    Oren Livnat Livnat - Analyst

  • All right. Thanks so much.

    好的。非常感謝。

  • Operator

    Operator

  • Ladies and gentlemen, this concludes the question-and-answer session. I'll turn the call back to Mike Heffernan for closing remarks.

    女士們、先生們,問答環節到此結束。我將把電話轉回給邁克·赫弗南 (Mike Heffernan) 作結束語。

  • Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

    Michael Heffernan - Chairman of the Board, Interim President, Chief Executive Officer

  • Thank you, everyone, for joining the call today. Have a great evening.

    謝謝大家今天加入電話會議。祝您有個美好的夜晚。

  • Operator

    Operator

  • This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

    今天的會議到此結束。此時您可以斷開線路。感謝您的參與。