使用警語:中文譯文來源為 AI 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 second quarter 2026 earnings conference call. (Operator Instructions)
各位好,歡迎參加 Collegium Pharmaceutical 2026 年第二季財報電話會議。(接線員指示)
I will now like to turn the call over to Ian Karp, Head of Investor Relations. Thank you. You may begin.
現在我想把電話交給投資人關係主管 Ian Karp。謝謝。您可以開始了。
Ian Karp - Head of Investor Relations
Ian Karp - Head of Investor Relations
Great, thanks so much, and welcome to Collegium Pharmaceutical second quarter 2026 earnings conference call. I'm joined today by Vikram Karnani, our President and Chief Executive Officer, and Colleen Tupper, our Chief Financial Officer. 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. You are cautioned that such forward-looking statements involve risks and uncertainties, as detailed in the company's periodic reports filed with the Securities and Exchange Commission. 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.
太好了,非常感謝,也歡迎各位參加 Collegium Pharmaceutical 2026 年第二季財報電話會議。今天與我一同出席的有我們的總裁兼執行長 Vikram Karnani,以及財務長 Colleen Tupper。在開始今天的會議之前,我們想提醒與會者,今天所呈現的任何資訊均非用於促銷,且今天所作的任何前瞻性陳述皆依據 1995 年《私人證券訴訟改革法案》的安全港條款提出。請注意,此類前瞻性陳述涉及風險與不確定性,相關內容已在公司向美國證券交易委員會提交的定期報告中詳述。我們未來的結果可能與今天討論的目前預期存在重大差異。我們的財報新聞稿與本次電話會議將包含對某些非 GAAP 資訊的討論。
You can find our earnings press release, including relevant non-GAAP reconciliations, on our corporate website. With that, I'll now turn the call over to our President and CEO, Vikram Karnani.
您可在我們的公司網站上找到財報新聞稿(包含相關的非 GAAP 調節表)。接下來,我將把電話交給我們的總裁兼執行長 Vikram Karnani。
Vikram Karnani - President and CEO
Vikram Karnani - President and CEO
Thank you, Ian. Good morning, everyone, and thank you for joining our second quarter 2026 earnings call. Collegium is a dynamic biopharmaceutical company delivering medicines with formulation and delivery innovation for people living with complex CNS and pain conditions. Today, we have a diversified portfolio of six differentiated medicines, a growing ADHD franchise, and an established pain business that together provide a strong foundation for long-term value creation. We have a demonstrated ability to acquire, integrate, and grow differentiated assets while deploying capital in a disciplined manner. This quarter, we delivered strong results, highlighted by significant progress in our rapidly growing ADHD business. Key achievements included JORNAY prescriptions grew by 13.1%, generating $46.1 million in net revenue, up 41% year-over-year.
謝謝你,Ian。各位早安,感謝各位參加我們 2026 年第二季財報電話會議。Collegium 是一家充滿活力的生物製藥公司,透過製劑與給藥創新,為罹患複雜中樞神經系統(CNS)與疼痛疾病的患者提供藥物。目前我們擁有由六項具差異化的藥品所構成的多元化產品組合、持續成長的 ADHD 產品線,以及成熟的疼痛業務,三者共同為長期價值創造奠定堅實基礎。我們已展現出收購、整合並擴大具差異化資產的能力,同時以嚴謹紀律部署資本。本季我們交出強勁成果,亮點在於快速成長的 ADHD 業務取得顯著進展。主要成就包括:JORNAY 處方量成長 13.1%,帶來 4,610 萬美元淨營收,年增 41%。
JORNAY prescribers reached an all-time high with over 30,000 healthcare providers writing JORNAY prescriptions in the quarter, up 17.6% over Q2 of last year. Importantly, we completed the acquisition of AZSTARYS in May, which now provides us with a differentiated and highly complementary medicine to JORNAY PM. This latest acquisition further reinforces the strategy we initiated in 2024 to diversify our portfolio beyond responsible pain management and establish a strong presence in the growing ADHD market. The integration of AZSTARYS and product training of our expanded sales force is now complete, and the team is well positioned to further accelerate growth for both medicines ahead of the back-to-school season, which begins later this month. Switching to our pain portfolio, we generated $140.9 million in revenue in this quarter. BELBUCA performed particularly well, with revenues up 10% year-over-year.
本季開立 JORNAY 處方的醫療照護提供者(HCP)超過 30,000 位,創下歷史新高,較去年第二季增加 17.6%。重要的是,我們已於 5 月完成 AZSTARYS 的收購,該產品如今為我們提供一項具差異化且與 JORNAY PM 高度互補的藥物。這項最新收購進一步強化我們自 2024 年啟動的策略:將產品組合多元化,超越負責任的疼痛管理,並在成長中的 ADHD 市場建立強勢布局。AZSTARYS 的整合以及擴編銷售團隊的產品訓練現已完成;團隊已做好準備,在本月稍晚開始的返校季前,進一步加速兩項藥物的成長。轉到疼痛產品組合,本季我們創造 1.409 億美元營收。BELBUCA 表現尤其亮眼,營收年增 10%。
In addition, we recently secured formulary access to an additional 9 million lives, which goes into effect in the fourth quarter. Offsetting BELBUCA's performance, revenue from the NUCYNTA franchise was lower than expected due to pricing for the authorized generic products. Colleen will discuss this financial impact in greater detail. Overall, we achieved both top and bottom line growth, with total net product revenues up 6% and adjusted EBITDA up 8% year-over-year. Turning now to other recent corporate updates. During the quarter, we remained focused on our commitment to leading with science and generated additional clinical evidence supporting our portfolio through multiple medical presentations and publications. Once again, Collegium was recognized by the Boston Business Journal as one of the 2026 best places to work in Massachusetts and named a USA Today top workplace for 2026.
此外,我們近期也取得額外 900 萬名受保人(lives)的處方集(formulary)給付准入,並將於第四季生效。與 BELBUCA 的表現相抵,NUCYNTA 產品線的營收低於預期,原因在於授權學名藥(authorized generic)產品的定價。Colleen 將更詳細說明其財務影響。整體而言,我們在營收與獲利兩端皆實現成長:總淨產品營收年增 6%,調整後 EBITDA 年增 8%。接著談其他近期公司更新。本季我們持續聚焦於以科學為本的承諾,並透過多場醫學簡報與發表,產出更多支持我們產品組合的臨床證據。Collegium 再次獲《Boston Business Journal》評選為 2026 年麻薩諸塞州最佳雇主之一,並獲《USA Today》評為 2026 年最佳職場。
I'm very proud of the entire team at Collegium for their continued hard work and dedication in support of the patient communities we serve. Finally, we recently announced plans to relocate our corporate headquarters to downtown Boston in the first quarter of 2027, further integrating Collegium into one of the world's leading healthcare and life sciences ecosystems. In the second half of 2026, we are focused on three key strategic priorities: growing our ADHD business, maximizing the value of our pain portfolio, and strategically deploying capital to create long-term shareholder value.
我為 Collegium 全體團隊持續的努力與投入感到非常自豪,大家共同支持我們所服務的病患社群。最後,我們近期宣布計畫於 2027 年第一季將公司總部遷至波士頓市中心,進一步讓 Collegium 融入全球領先的醫療保健與生命科學生態系之一。在 2026 年下半年,我們聚焦三項關鍵策略優先事項:擴大 ADHD 業務、最大化疼痛產品組合價值,以及策略性部署資本以創造長期股東價值。
Based on the ongoing progress across our ADHD business and the strategic investments we have made ahead of this year's back-to-school season, we remain confident in our full year expectations for $190 million to $200 million in JORNAY PM revenues and have increased our expectations to $65 million to $75 million in partial year AZSTARYS revenues. For our pain portfolio, we continue to implement strategies to maximize the durability of these revenues, which provides a solid base to our business and allows us to invest in our key growth drivers and capital deployment strategy. Finally, executing our disciplined capital deployment strategy remains a core priority, as was evidenced by our recent acquisition of AZSTARYS, designed to accelerate our growth opportunities.
基於我們在 ADHD 業務上的持續進展,以及為今年返校季所做的策略性投資,我們仍對全年 JORNAY PM 營收 1.90 億至 2.00 億美元的預期充滿信心,並將 AZSTARYS(部分年度)營收預期上調至 6,500 萬至 7,500 萬美元。就疼痛產品組合而言,我們持續推動各項策略以最大化這些營收的持久性,為公司提供穩固的業務基礎,並使我們得以投資於關鍵成長動能與資本部署策略。最後,落實我們嚴謹的資本部署策略仍是核心優先事項;近期收購 AZSTARYS 即為明證,該交易旨在加速我們的成長機會。
We are encouraged by our momentum heading into the second half of the year and remain confident in our ability to execute against these strategic priorities. T urning now to our commercial highlights. Starting off with our lead growth driver, JORNAY PM, a highly differentiated medicine and the only ADHD stimulant that provides all-day symptom control that starts immediately upon awakening. Driven by our targeted investments and enhanced commercial efforts, HCP perceptions of JORNAY are very positive, and we have seen that enthusiasm increase. Based on market research conducted in the first quarter of 2026, HCPs had a high favourability rating and again ranked JORNAY as the number one branded ADHD medicine in terms of product differentiation, with a score significantly higher than all other medicines in the same category.
我們對於進入下半年所展現的動能感到鼓舞,並對於執行上述策略優先事項的能力保持信心。接下來轉到商業面亮點。首先談我們最主要的成長驅動因素 JORNAY PM:這是一款高度差異化的藥物,也是唯一一種可提供全天症狀控制、且在醒來後立即開始發揮效果的 ADHD 興奮劑。在我們的精準投資與強化商業推進的帶動下,醫療照護提供者(HCP)對 JORNAY 的觀感非常正面,且我們看到這份熱忱持續升溫。根據 2026 年第一季進行的市場研究,HCP 給予高度好感度評分,並再次將 JORNAY 評為在產品差異化方面排名第一的品牌 ADHD 藥物,其分數顯著高於同類別的所有其他藥物。
In addition, 70% of HCP surveyed indicated a strong intent to increase prescribing, which was the highest among all other branded ADHD medicines. HCP awareness of JORNAY has significantly improved in the last year. Unaided recall amongst target HCPs increased to 67%, up from 52%, approaching the awareness levels of established brands like VYVANSE and CONCERTA. Collegium is ranked number one in reputation among pharmaceutical companies specializing in ADHD, and market research indicates that we are focused on the right messages and that our sales force is viewed as highly effective in their delivery. JORNAY continues to be the fastest-growing stimulant for the treatment of ADHD. In the second quarter, we saw strong JORNAY growth trends in prescriptions, prescribers, and market share. Specifically, we saw JORNAY PM prescriptions up 13.1% year-over-year.
此外,受訪的 HCP 中有 70% 表示強烈意願增加開立處方,為所有其他品牌 ADHD 藥物中最高。過去一年,HCP 對 JORNAY 的認知度已顯著提升。在目標 HCP 中的非提示回想(unaided recall)提升至 67%,高於先前的 52%,並逐步接近 VYVANSE 與 CONCERTA 等既有品牌的認知水準。在專注於 ADHD 的製藥公司中,Collegium 的聲譽排名第一;市場研究顯示,我們聚焦於正確的訊息,且我們的銷售團隊在傳遞上被視為高度有效。JORNAY 仍是治療 ADHD 的成長最快的興奮劑。第二季我們在 JORNAY 的處方量、開立處方者數量與市占率方面皆看到強勁的成長趨勢。具體而言,JORNAY PM 處方量年增 13.1%。
We also hit an all-time high for JORNAY prescribers in the quarter, with over 30,000 healthcare providers writing JORNAY prescriptions, up 17.6% year-over-year. We grew our share of the branded long-acting methylphenidate market to 29.2%, up 5.8 percentage points year-over-year. We saw solid growth across both the paediatric and adult segments. In the paediatric and adolescent segment, which represents about 80% of our business, total prescriptions grew 10.7% year-over-year. The adult segment, representing about 20% of our total prescriptions, grew 23% year-over-year. Overall, we expect JORNAY's strong growth trajectory to continue in the second half of the year, further bolstered as we enter the back-to-school season. In addition to growing JORNAY, we completed the acquisition of AZSTARYS in May, bringing a second highly differentiated ADHD medicine into our portfolio.
本季我們的 JORNAY 開立處方醫師數也創下歷史新高,超過 30,000 名醫療照護提供者開立 JORNAY 處方,年增 17.6%。我們在品牌長效甲基苯idate(methylphenidate)市場的市占率提升至 29.2%,較去年同期增加 5.8 個百分點。我們在兒科與成人兩個族群皆見到穩健成長。在兒科與青少年族群(約占我們業務的 80%)中,總處方量年增 10.7%。成人族群約占我們總處方量的 20%,年增 23%。整體而言,我們預期 JORNAY 強勁的成長軌跡將在下半年延續,並在進入返校季時進一步獲得助力。除推動 JORNAY 成長外,我們也於 5 月完成對 AZSTARYS 的收購,為我們的產品組合帶來第二款高度差異化的 ADHD 藥物。
The acquisition strengthens our ADHD platform in several ways. Market research suggests that AZSTARYS is the second most differentiated stimulant brand following JORNAY PM, despite not benefiting from broader commercial investment under its prior owner. It has IP protection through 2037, extending the life cycle of our commercial portfolio. It enables significant cost synergies, allowing us to leverage our existing commercial infrastructure. It is immediately accretive to adjusted EBITDA with a greater impact anticipated in 2027 and beyond. Most importantly, it provides significant potential benefits to patients. AZSTARYS is the first and only ADHD treatment with both fast and long-acting medicines in one capsule. JORNAY PM and AZSTARYS are highly complementary as they serve different patient types.
這項收購在多個面向強化了我們的 ADHD 平台。市場研究顯示,AZSTARYS 是僅次於 JORNAY PM 的第二大差異化興奮劑品牌,儘管在前任所有者旗下並未受惠於更廣泛的商業投資。其智慧財產權保護可延續至 2037 年,延長我們商業產品組合的生命週期。它可帶來顯著的成本綜效,使我們能運用既有的商業基礎設施。它將立即增厚調整後 EBITDA,且預期在 2027 年及之後影響更為顯著。最重要的是,它可為病患帶來顯著的潛在效益。AZSTARYS 是第一且唯一一款在單一膠囊中同時包含速效與長效藥物的 ADHD 治療。JORNAY PM 與 AZSTARYS 具高度互補性,因其服務不同類型的病患。
JORNAY PM is for the patient who needs their all-day symptom control to start immediately upon awakening, while AZSTARYS is for the patient who needs the flexibility of rapid onset symptom control to last later into the evening. HCP perceptions of AZSTARYS are also very positive. In market research, healthcare professionals rated AZSTARYS highly in terms of product differentiation and brand favourability. We also continue to receive highly positive feedback from both KOLs and community-based physicians regarding the addition of AZSTARYS into the Collegium portfolio, particularly regarding the opportunity to bring together two best-in-class methylphenidate treatments addressing distinct patient needs. KOLs also view this as an important signal of Collegium's long-term commitment to advancing care in ADHD. Since the close of the AZSTARYS acquisition, we have been focused on rapidly integrating the product into our portfolio.
JORNAY PM 適用於需要在醒來後立即開始、並維持全天症狀控制的病患;而 AZSTARYS 則適用於需要具彈性的快速起效症狀控制、且效果可延續至較晚傍晚的病患。醫療照護專業人員(HCP)對 AZSTARYS 的觀感也非常正面。在市場研究中,醫療專業人員在產品差異化與品牌好感度方面給予 AZSTARYS 很高的評價。我們也持續收到來自關鍵意見領袖(KOL)與社區型醫師對於將 AZSTARYS 納入 Collegium 產品組合的高度正面回饋,尤其是關於有機會整合兩款同級最佳的甲基苯idate(methylphenidate)治療,以滿足不同病患需求。KOL 也將此視為 Collegium 長期致力於推動 ADHD 照護進展的重要訊號。自 AZSTARYS 收購完成以來,我們一直專注於快速將該產品整合至我們的產品組合中。
This includes increasing our ADHD sales force to about 190 reps, up from 180 prior to the acquisition, and growing our target HCPs to about 27,000, up from 21,000 pre-expansion in 2025. All of our sales representatives are now fully trained and selling both products to all targets ahead of the back-to-school season, which begins later this month. In addition, over the past year, targeted patient and caregiver outreach, particularly through social media platforms, has successfully increased awareness and trial for JORNAY PM. These commercial tactics will now be deployed for AZSTARYS and represent an additional opportunity to support future growth. We have also been making incremental strategic investments to our medical affairs, market access, and regulatory teams to further support and maximize these two growing brands.
這包括將我們的 ADHD 銷售團隊擴增至約 190 名業務代表,高於收購前的 180 名,並將目標 HCP 擴大至約 27,000 名,高於 2025 年擴張前的 21,000 名。在本月稍晚開始的返校季之前,我們所有業務代表現已完成全面訓練,並向所有目標客戶同時推廣兩項產品。此外,在過去一年中,針對病患與照護者的精準外展(尤其透過社群媒體平台)已成功提升 JORNAY PM 的認知度與試用率。這些商業策略將現已部署於 AZSTARYS,並代表支持未來成長的另一項機會。我們也持續對醫藥事務、市場准入與法規團隊進行增量的策略性投資,以進一步支持並最大化這兩個成長中品牌的價值。
Ultimately, our goal is to increase awareness and adoption for both products while optimally leveraging our infrastructure and commercial expertise. We are excited by the outlook of our ADHD portfolio and look forward to providing future updates later this year. Turning now to our pain portfolio. Our responsible pain management business continues to provide a durable foundation for Collegium, generating strong cash flow that supports investment in our growth priorities. BELBUCA continued to perform well during the quarter, with revenues increasing 10% year-over-year, driven by stable prescription demand and improved profitability. Looking ahead, BELBUCA also recently secured formulary access for an additional 9 million lives starting in Q4 of this year.
最終,我們的目標是在最佳化運用我們的基礎設施與商業專長的同時,提高兩項產品的認知度與採用率。我們對 ADHD 產品組合的前景感到振奮,並期待在今年稍晚提供後續更新。接下來談談我們的疼痛產品組合。我們的負責任疼痛管理業務持續為 Collegium 提供穩健且可長期維持的基礎,創造強勁現金流以支持我們對成長優先事項的投資。BELBUCA 本季持續表現良好,營收年增 10%,主要受穩定的處方需求與獲利能力改善所帶動。展望未來,BELBUCA 近期也取得額外 900 萬人次(lives)的處方集(formulary)准入,將自今年第四季開始生效。
Revenue from XTAMPZA declined year-over-year, reflecting both pressure across the branded long-acting opioid market and an unfavourable comparison to the second quarter of 2025, which benefited from the timing of rebate settlements. Revenue for the NUCYNTA franchise was lower than expected due to net pricing for the authorized generic versions of NUCYNTA and NUCYNTA ER. We have updated our full year guidance, which Colleen will discuss in greater detail. Our pain business continues to serve as a strong cash-generating strategic asset, providing financial flexibility to invest in the growth of our ADHD business, execute disciplined business development opportunities, and return capital to our shareholders. I will now hand the call over to Colleen to discuss our financial highlights.
XTAMPZA 的營收較去年同期下滑,反映品牌長效阿片類藥物市場整體承壓,以及與 2025 年第二季的不利比較;當時受惠於回扣結算時點。NUCYNTA 系列的營收低於預期,原因在於 NUCYNTA 與 NUCYNTA ER 授權學名藥版本的淨定價影響。我們已更新全年財測指引,Colleen 將進一步詳細說明。我們的疼痛業務仍是強勁的現金創造型策略資產,提供財務彈性以投資 ADHD 業務成長、執行嚴謹的業務開發機會,並向股東返還資本。接下來我將把電話會議交給 Colleen,請她說明我們的財務重點。
Colleen Tupper - Chief Financial Officer, Executive Vice President
Colleen Tupper - Chief Financial Officer, Executive Vice President
Thanks, Vikram. Good morning, everyone. In the second quarter, we again saw significant growth in JORNAY, along with initial revenue from AZSTARYS and meaningful revenues from our pain portfolio. Financial highlights for the second quarter include total net product revenues were $199.9 million in the quarter, up 6% year-over-year. JORNAY net revenue was $46.1 million in the quarter, up 41% year-over-year. AZSTARYS revenues were $12.9 million, which reflect about a month and a half of commercial sales. BELBUCA net revenue was $57.7 million in the quarter, up 10% year-over-year. XTAMPZA ER net revenue was $45 million in the quarter, down 14% year-over-year. This quarter provided a challenging comparison to Q2 2025, when XTAMPZA benefited from the timing of rebate settlements totalling approximately $2.4 million. Total NUCYNTA franchise net revenue was $35.2 million in the quarter, down 24% year-over-year.
謝謝你,Vikram。各位早安。在第二季,我們再次看到 JORNAY 的顯著成長,同時也有來自 AZSTARYS 的初始營收,以及疼痛產品組合帶來的可觀營收。第二季財務重點包括:本季產品淨營收總額為 1.999 億美元,年增 6%。JORNAY 本季淨營收為 4,610 萬美元,年增 41%。AZSTARYS 營收為 1,290 萬美元,反映約一個半月的商業銷售。BELBUCA 本季淨營收為 5,770 萬美元,年增 10%。XTAMPZA ER 本季淨營收為 4,500 萬美元,年減 14%。本季與 2025 年第二季相比具挑戰性,當時 XTAMPZA 受惠於回扣結算時點,合計約 240 萬美元。NUCYNTA 系列本季淨營收總額為 3,520 萬美元,年減 24%。
This includes $5.1 million in revenue from the profit share on the authorized generic versions of NUCYNTA and NUCYNTA ER. GAAP operating expenses were $106.6 million in the quarter, up 45% year-over-year. This quarter included $24.1 million in acquisition-related expenses associated with the AZSTARYS acquisition. Adjusted operating expenses, which excludes stock-based compensation and acquisition-related expenses, were $66.6 million, up 8% year-over-year. GAAP net loss was $15.1 million in the quarter, compared to net income of $12 million in Q2 2025. Non-GAAP adjusted EBITDA was $113.8 million in the quarter, up 8% year-over-year. GAAP loss per share were $0.46 basic and diluted in the quarter, compared to earnings of $0.38 basic and $0.34 diluted in the prior year quarter. Non-GAAP adjusted earnings per share was $1.92 in the quarter, compared to $1.68 in the prior year quarter.
其中包括來自 NUCYNTA 與 NUCYNTA ER 授權學名藥版本利潤分成的 510 萬美元營收。本季 GAAP 營業費用為 1.066 億美元,年增 45%。本季包含與 AZSTARYS 收購相關的 2,410 萬美元收購相關費用。調整後營業費用(排除以股票為基礎之酬勞及收購相關費用)為 6,660 萬美元,年增 8%。本季 GAAP 淨損為 1,510 萬美元,相較於 2025 年第二季淨利 1,200 萬美元。本季非 GAAP 調整後 EBITDA 為 1.138 億美元,年增 8%。本季 GAAP 每股虧損為基本及稀釋後各 0.46 美元,相較於去年同期基本每股盈餘 0.38 美元、稀釋後每股盈餘 0.34 美元。本季非 GAAP 調整後每股盈餘為 1.92 美元,相較於去年同期 1.68 美元。
Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. We generated operating cash flows of $71.3 million in the second quarter, and as of June 30th, we had $129.5 million in cash equivalents, and marketable securities. As a reminder, we used approximately $356 million in cash on hand to fund the acquisition of AZSTARYS that closed during the second quarter. We are updating our 2026 financial guidance primarily to reflect lower than expected full year revenue for the NUCYNTA franchise due to lower net pricing for the authorized generics. Importantly, our revenue expectations for JORNAY remain unchanged, with guidance of $190 million to $200 million. We are also increasing our revenue outlook for AZSTARYS, now expecting $65 million to$75 million following successful integration and encouraging early performance.
請參閱我們今日稍早發布的新聞稿,以取得 GAAP 與非 GAAP 結果之調節表。第二季我們產生的營運現金流為 7,130 萬美元;截至 6 月 30 日,我們持有 1.295 億美元的約當現金及有價證券。提醒一下,我們使用約 3.56 億美元的手頭現金為第二季完成交割的 AZSTARYS 收購案提供資金。我們正在更新 2026 年財務指引,主要反映由於授權學名藥淨售價較低,導致 NUCYNTA 產品線全年營收低於預期。重要的是,我們對 JORNAY 的營收預期維持不變,指引為 1.90 億至 2.00 億美元。我們也上調 AZSTARYS 的營收展望,在成功整合且早期表現令人鼓舞之後,目前預期為 6,500 萬至 7,500 萬美元。
We now expect total product revenues in the range of $825 million to$855 million. This represents an 8% increase year-over-year at the midpoint, driven by JORNAY PM growth and contributions from AZSTARYS, partially offset by lower pain portfolio net revenue. We expect adjusted EBITDA in the range of $445 millionto$470 million, essentially flat compared to 2025. Finally, we expect JORNAY gross to net to remain stable in 2026 in the mid60% range. Our capital deployment strategy remains focused on creating long-term value for our shareholders by executing on business development, paying down debt, and opportunistically returning capital to shareholders. We successfully completed the AZSTARYS acquisition this past quarter and are efficiently integrating it into our portfolio. We ended the quarter with net debt to adjusted EBITDA of approximately 2.1 times.
我們目前預期總產品營收介於 8.25 億至 8.55 億美元。以中位數計算,這代表年增 8%,主要由 JORNAY PM 成長及 AZSTARYS 的貢獻所帶動,但部分被疼痛產品組合淨營收下降所抵銷。我們預期調整後 EBITDA 介於 4.45 億至 4.70 億美元,與 2025 年基本持平。最後,我們預期 2026 年 JORNAY 的毛額轉淨額(gross-to-net)將維持穩定,約在 60% 中段區間。我們的資本配置策略仍聚焦於透過推動業務發展、償還債務,以及在適當時機回饋資本給股東,為股東創造長期價值。我們在上一季成功完成 AZSTARYS 收購,並正有效率地將其整合至我們的產品組合中。本季末我們的淨負債對調整後 EBITDA 約為 2.1 倍。
I will now turn the call back to Vikram for some final remarks.
我現在把電話交回給 Vikram 做最後的補充說明。
Vikram Karnani - President and CEO
Vikram Karnani - President and CEO
Thank you, Colleen. Following the close of the AZSTARYS acquisition, our ADHD portfolio is on an exciting trajectory. With the integration complete and our commercial organization fully trained, we are well-positioned heading into the important back-to-school season. Our strategy to diversify our business beyond responsible pain management began in 2024 and has now been meaningfully strengthened by this recent acquisition. We are particularly encouraged by the long-term growth potential of the combined portfolio, as well as the cost synergies we are already beginning to realize. In the second half of the year, we remain committed to our three key strategic priorities, driving continued growth for our ADHD portfolio, maximizing the durability of our pain portfolio, and strategically deploying capital. The underlying fundamentals of our business remain strong.
謝謝你,Colleen。在 AZSTARYS 收購完成後,我們的 ADHD 產品組合正走在令人振奮的成長軌道上。隨著整合完成且我們的商業團隊已全面受訓,我們已為重要的返校季做好充分準備。我們自 2024 年起推動將業務多元化、超越負責任的疼痛管理之策略,而這次收購已顯著強化該策略。我們對合併後產品組合的長期成長潛力,以及我們已開始實現的成本綜效,感到特別振奮。在今年下半年,我們仍致力於三項關鍵策略優先事項:推動 ADHD 產品組合持續成長、最大化疼痛產品組合的持久性,以及策略性地配置資本。我們業務的基本面仍然強勁。
We continue to generate significant cash flows and strong profitability, giving us the financial flexibility to invest behind our growth drivers, strengthen our portfolio, and return capital to shareholders. I remain confident in our journey to building a leading diversified biopharmaceutical company. We have a clear strategy, a strong portfolio, and the financial discipline to continue creating long-term value. I look forward to updating you on our continued progress. With that, we'll now open the call up for Q&A. Operator?
我們持續創造可觀的現金流與強勁的獲利能力,使我們具備財務彈性,得以投資於成長動能、強化產品組合,並回饋資本給股東。我仍對我們打造領先的多元化生物製藥公司的旅程充滿信心。我們擁有清晰的策略、強大的產品組合,以及持續創造長期價值所需的財務紀律。我期待向各位更新我們持續取得的進展。接下來,我們將開放問答。接線員?
Operator
Operator
(Operator Instructions)
(接線員指示)
Serge Belanger, Needham & Company
Serge Belanger,Needham & Company
Serge Belanger - Analyst
Serge Belanger - Analyst
Hi, good morning. Thanks for taking my question. I guess to start off with on NUCYNTA, has the net price from the authorized generic now stabilized, or do you expect any additional erosion on the pricing level? Secondly, since I think we're probably going to get questions on the IP duration of pain portfolio, can you just remind us your expectations for potential generic competition on BELBUCA, since I believe some of the IP expires in 2027, and whether you have an authorized generic strategy for that product also? Thanks.
嗨,早安。謝謝讓我提問。我想先從 NUCYNTA 開始:授權學名藥的淨售價現在是否已經穩定下來,還是你們預期價格水準還會有進一步下滑?第二,因為我想我們可能會被問到疼痛產品組合的智慧財產權期限,你能否提醒我們對 BELBUCA 可能面臨學名藥競爭的預期?我相信部分 IP 會在 2027 年到期;另外你們是否也有針對該產品的授權學名藥策略?謝謝。
Colleen Tupper - Chief Financial Officer, Executive Vice President
Colleen Tupper - Chief Financial Officer, Executive Vice President
Morning, Serge. Thanks for the questions. On NUCYNTA, I would expect the net pricing to have stabilized at this point, and that is reflected in our full-year guidance. I would point you to Q1 and Q2 had timing dynamics of that with the initial supply to the authorized generic distributor. I would look at first half of 2026 in totality. The second comment I would make about sort of the revenue recognition is keep in mind for this arrangement, as is typical, we book revenue at the time of supplying the authorized generic distributor. That revenue that is booked is a combination of the sale of the material of the product as well as an estimated profit share.
早安,Serge。謝謝你的問題。就 NUCYNTA 而言,我預期淨售價在此時點已趨於穩定,這也反映在我們的全年指引中。我會提醒你注意第一季與第二季在時間點上有一些動態因素,與初期供貨給授權學名藥經銷商有關。我會把 2026 年上半年作為整體來看。關於營收認列,我要補充的第二點是:請記住,對於此類安排(如同一般慣例),我們在供貨給授權學名藥經銷商時即認列營收。所認列的營收包含產品實體的銷售,以及估計的利潤分成。
There is some lumpiness that could be in each quarter given that accounting, but we do believe the net price has stabilized at this point. On the second question for the pain LOEs, I'll just start with XTAMPZA. One NDA filer fully settled for September of 2033. BELBUCA, thus far, the event we are watching for, we've spoken to in the past is that in January of 2027, Teva, via a settlement agreement, does have the ability to launch a generic. We've spoken at length in the past. We do not believe that aligns with their strategy based on comments they have made, but we do watch for that. We do have an authorized generic agreement in place, and it has been in place for years.
基於該會計處理,每一季可能會出現一些不均勻(lumpiness),但我們確實認為目前淨售價已經穩定。至於第二個問題、關於疼痛產品的專利到期(LOE),我先從 XTAMPZA 談起。有一家 NDA 申請者已完全和解,日期為 2033 年 9 月。就 BELBUCA 而言,截至目前我們關注的事件、也曾在過去提及的是:依據和解協議,Teva 在 2027 年 1 月確實具備推出學名藥的能力。我們過去已詳細討論過。根據他們所做的評論,我們不認為那與其策略一致,但我們仍會持續關注。我們已建立授權學名藥協議,而且已經存在多年。
That agreement is your typical agreement where the launch of the authorized generic is triggered upon an external generic launching. Whether that be Teva in early 2027 or one of the other parties that is filing and held off a bit further. Alvogen in particular has been litigated and currently is barred from the market until December of 2032.
該協議屬於典型的協議類型,即一旦外部學名藥上市,即觸發授權學名藥(authorized generic)的上市。無論是 Teva 於 2027 年初上市,或是其他已提出申請但再延後一段時間才上市的業者。尤其是 Alvogen 已涉入訴訟,目前被禁止進入市場,直到 2032 年 12 月。
Operator
Operator
Dennis Ding, Jefferies
Dennis Ding,Jefferies
Dennis Ding - Analyst
Dennis Ding - Analyst
Hi, good morning. I have two questions, if I may. Number one, just on ADHD, I'm glad to see beats across both JORNAY and AZSTARYS as you guys diversify away from pain. Can you comment how much of the AZSTARYS beat came from a change in channel dynamics as the drugs switch hands? Presumably, your larger distribution network could have led to a little bit more stocking than anticipated. Also, if you can comment on gross to net in the accounting, since that could also change depending on who owns it. That's question number one. Question number two is around NUCYNTA. Net price was much lower than you expected. We're getting to around a 75% discount on the IR and 50% discount on the ER. Is that in the ballpark or are we really off?
嗨,早安。如果可以的話,我有兩個問題。第一個是關於 ADHD,很高興看到你們在 JORNAY 與 AZSTARYS 兩者都有優於預期的表現,並且在業務上逐步分散對止痛領域的依賴。你們能否評論一下,AZSTARYS 優於預期的部分,有多少是來自通路動態的變化(藥品換手後通路端的變化)?推測你們更大的配送網路,可能導致比預期略多的鋪貨/備貨。另外,也請你們談談會計上的 gross-to-net(毛額到淨額)情況,因為這也可能會隨著所有權不同而改變。這是第一個問題。第二個問題是關於 NUCYNTA。淨價格比你們預期低很多。我們看到 IR 大約有 75% 的折扣、ER 大約有 50% 的折扣。這是在合理範圍內,還是我們的估算差很多?
I believe it's also a volume-limited agreement with Hikma, correct? Maybe comment on the different thresholds in terms of the volume step-up. Thanks so much.
我相信你們與 Hikma 的協議也是有量的限制,對嗎?也請談談在銷量階梯式提升(volume step-up)方面,不同門檻的設定。非常感謝。
Vikram Karnani - President and CEO
Vikram Karnani - President and CEO
Yeah. Thanks, Dennis. I think just to start out on AZSTARYS, that the update on the guidance is a reflection of the expectations from performance, commercial performance, and has nothing to do with channel dynamics or any initial ordering of inventory or anything like that. Colleen, you want to take the next one?
是的。謝謝你,Dennis。我想先從 AZSTARYS 開始說明:此次指引更新反映的是我們對其表現、商業化表現的預期,與通路動態或任何初期的庫存下單等因素無關。Colleen,你要接著回答下一題嗎?
Colleen Tupper - Chief Financial Officer, Executive Vice President
Colleen Tupper - Chief Financial Officer, Executive Vice President
Let me just add on the AZSTARYS comment, though, Dennis, I think you also mentioned a beat to consensus. I think that was predominantly that consensus, it was a first quarter, it was a partial quarter, and I don't think there was full recognition on how much revenue there would be. I might point you to our pro formas that were filed, which reflect in Q1 2026 Pro forma revenue for AZSTARYS was about $25 million. Gross to net under our first quarter of ownership, again, it was partial quarter, about 50% of the quarter was running at about 74%. We do expect that that will improve over time, but not to the same degree of that step change that we achieved with JORNAY. I hope that covered your comment about the beat to consensus. On net price for NUCYNTA.
Dennis,我再補充一下 AZSTARYS 的部分。我想你也提到它優於市場共識。我認為那主要是因為市場共識是以第一季為基礎,而那是一個不完整的季度(partial quarter),市場並未充分反映會認列多少營收。我建議你參考我們已提交的 pro forma(備考)資料,其中顯示 2026 年第一季 AZSTARYS 的備考營收約為 2,500 萬美元。在我們持有的第一季(同樣是不完整季度)中,gross-to-net 約為 74%,其中大約有 50% 的季度期間是以該水準運行。我們確實預期該數字會隨時間改善,但改善幅度不會像我們在 JORNAY 上達成的那種階躍式變化(step change)那麼大。希望這回答了你關於優於共識的問題。至於 NUCYNTA 的淨價格。
Dennis, I think the easiest way to think about it, and again, with this stabilized now, is if you look at branded net price for NUCYNTA IR, the AG, we're netting about 10%to15% of that. If you look at branded net price for ER, we are netting between 20% and 25% for the AG volume. I think that math works for what you just referenced, but I wanted to give you those two anchor points.
Dennis,我認為最簡單的理解方式是——而且現在已經穩定下來——如果你看 NUCYNTA IR 的品牌藥淨價格,對於 AG(授權學名藥),我們實際取得的淨額大約是其 10% 到 15%。如果你看 ER 的品牌藥淨價格,對於 AG 的銷量,我們取得的淨額大約在 20% 到 25% 之間。我認為這樣的換算與你剛才提到的折扣幅度是一致的,但我想提供這兩個基準點給你。
Dennis Ding - Analyst
Dennis Ding - Analyst
Perfect. Thanks so much.
太好了。非常感謝。
Operator
Operator
Brandon Folkes, H.C. Wainwright
Brandon Folkes,H.C. Wainwright
Brandon Folkes - Equity Analyst
Brandon Folkes - Equity Analyst
Hi, thanks for taking my questions, and congrats on the quarter. Maybe just two from me. Granted it's early, but can you provide any feedback that you're hearing from field reps and prescribers about the distinctions in selling both AZSTARYS and JORNAY? Are prescribers comfortable with the differentiation at this time? Does it take a bit of discussion and sort of education in terms of where you are with your targets? Any feedback from field reps that they are getting adequate time in front of those prescribers to detail both? The second one, maybe just for Colleen. Can you just talk about SG&A spend for the rest of the year? Granted, you do have updated guidance there, so maybe just any changes in your prior guidance. Obviously looks disciplined in 2Q post AZSTARYS acquisition. Thank you.
嗨,謝謝回答我的問題,也恭喜本季表現。我這邊可能兩個問題。雖然還早,但你們能否分享一下,從第一線業務代表與開立處方的醫師那邊聽到的回饋:在同時銷售 AZSTARYS 與 JORNAY 時,兩者在銷售主張上的差異是什麼?目前醫師對於這種差異化是否感到自在?在你們鎖定的目標族群上,是否需要較多的討論與某種程度的教育?第一線業務代表是否回饋,他們有足夠的時間在這些醫師面前,完整介紹兩個產品?第二個問題可能給 Colleen。能否談談今年剩餘期間的 SG&A(銷售、一般及行政)支出?你們確實更新了相關指引,所以也許請談談相較於先前指引是否有任何變動。顯然在第二季、完成 AZSTARYS 收購後,你們看起來仍維持紀律。謝謝。
Vikram Karnani - President and CEO
Vikram Karnani - President and CEO
Thanks, Brandon. Yeah. Let me start out by providing some color on AZSTARYS and JORNAY now being part of the same portfolio. I think we discussed this during the acquisition and certainly at the announcement of the deal. Initial research during diligence had already suggested that physicians were pretty comfortable having had access to these two medicines over the past several years. Physicians have already become comfortable knowing how to position these two medicines for appropriate patient types. As I've said before, JORNAY PM is appropriate for the patient that needs symptom control upon awakening and effect that lasts throughout the day. Of course, as we've discussed, AZSTARYS provides more flexibility to the patient, especially those that are seeking rapid onset of action and then having extended control throughout the day.
謝謝你,Brandon。好的。我先補充一些背景,說明 AZSTARYS 與 JORNAY 現在同屬一個產品組合。我想我們在收購過程中,以及交易宣布時都談過這點。在盡職調查期間的初步研究就已顯示,醫師在過去幾年能使用這兩種藥物,因此相當能接受。醫師也已經熟悉如何將這兩種藥物定位於適合的病患類型。如我先前所說,JORNAY PM 適用於需要在醒來時就能控制症狀,且效果可持續一整天的病患。當然,如我們討論過的,AZSTARYS 能為病患提供更高的彈性,特別是那些希望快速起效,並在一天中維持延長控制的病患。
In our discussions with physicians after the acquisition, with now the same rep positioning both medicines, that has continued to be validated. I don't think that we have to provide any additional or different types of education. I think we continue to reinforce the same message and the same value proposition for the two individual medicines. As far as your second question related to time, absolutely. We heard this right in the beginning, right after the deal closed, when our combined field force was out there. We started to get more physician time already. Be it in the form of more lunch appointments or other opportunities for discussing the value propositions of these two medicines.
在收購後我們與醫師的討論中,現在由同一位業務代表同時推廣兩種藥物,這一點持續獲得驗證。我不認為我們需要提供任何額外或不同類型的教育。我們只是持續強化相同的訊息,以及這兩個個別藥物各自的價值主張。至於你第二個問題、關於拜訪時間,答案是絕對有。我們在一開始、交易剛完成、整合後的業務團隊外出拜訪時,就立刻聽到這樣的回饋。我們已經開始獲得更多醫師的時間。例如更多的午餐會面,或其他能討論這兩種藥物價值主張的機會。
Certainly, we are now in a more advantaged position, especially as it relates to getting time, both with the physicians as well as with the physician offices. That is certainly something that we heard right off the bat, after the deal closed and has continued. I expect will continue throughout this important back to school season. Before I turn the next question to Colleen, I think I just want to go back and reinforce the fact that having these two important medicines, which are complementary to each other in the portfolio, is going to certainly have an important impact through this back to school season when we expect rapid growth for both medicines. Colleen, maybe take the second question.
確實,我們現在處於更有利的位置,尤其是在取得時間方面,不論是與醫師本人或是與診所端。這是我們在交易完成後立刻就聽到的回饋,且一直持續至今。我預期在這個重要的返校季(back to school season)期間也會持續如此。在把下一題交給 Colleen 之前,我想再強調:產品組合中同時擁有這兩個重要、且彼此互補的藥物,將在這個返校季帶來重要影響;我們預期兩個產品都會快速成長。Colleen,也許你來回答第二個問題。
Colleen Tupper - Chief Financial Officer, Executive Vice President
Colleen Tupper - Chief Financial Officer, Executive Vice President
Great, Brandon. Good morning. On SG&A phasing, I would say we will have the expenses associated with AZSTARYS in the back half of the year. We modestly increased our territory footprint from 180 to 190 to support the addition of AZSTARYS. As you think about SG&A level in totality, the second half of the year will be, I would say, mid to upper single digit, higher than the first half of the year, accommodating the additional investment to support AZSTARYS. If I'm thinking about Q3 versus Q4, Q3 is a bit higher than Q4, given the back to school push and really the activities that support that. I hope that's helpful.
很好,Brandon。早安。關於SG&A費用的分期節奏,我會說我們將在下半年承擔與AZSTARYS相關的費用。為了支援新增的AZSTARYS,我們將銷售區域覆蓋範圍從180個小幅增加到190個。若從整體來看SG&A水準,我會說下半年將較上半年高出中到高個位數百分比,以容納為支援AZSTARYS所增加的投資。如果比較Q3與Q4,由於返校季的推廣以及真正支援該推廣的活動,Q3會比Q4略高一些。希望這些說明有幫助。
Brandon Folkes - Equity Analyst
Brandon Folkes - Equity Analyst
Very helpful.
非常有幫助。
Operator
Operator
David Amsellem,Piper Sandler.
David Amsellem,Piper Sandler。
Alex von Riesemann - biopharmaceutical equity research analyst
Alex von Riesemann - biopharmaceutical equity research analyst
Hi, good morning. This is Alex von Riesemann on for David. Thanks for taking our question. Regarding capital deployment post AZSTARYS, you've talked about rare disease in the past. You certainly have sizable infrastructure in ADHD. How are you thinking about the business and strategy now that you have a strong beachhead in ADHD? Is the goal to continue to leverage that infrastructure in psych, cast a wider net in psych, pivot to other therapeutic areas, or is it a pivot to rare disease, maybe both, or taking an opportunistic approach? Thank you.
嗨,早安。我是代替David提問的Alex von Riesemann。感謝讓我們提問。關於AZSTARYS之後的資本配置,你們過去談過罕見疾病。你們在ADHD方面確實擁有相當規模的基礎設施。在你們已在ADHD建立強而有力的灘頭堡之後,你們現在如何思考業務與策略?目標是繼續在精神科領域利用這些基礎設施、在精神科撒更大的網、轉向其他治療領域,還是轉向罕見疾病,或兩者兼具,或採取機會主義的做法?謝謝。
Vikram Karnani - President and CEO
Vikram Karnani - President and CEO
Yep, thank you for the question. Look, as we have discussed before, we remain committed to executing on a disciplined capital deployment strategy, which is a combination of continuing to look for differentiated assets to bring into our portfolio, as well as paying down our debt and strengthening our balance sheet, as well as returning capital to our shareholders in the form of opportunistic share repurchases. That remains our strategy going forward. Specifically, as it relates to business development, we have previously stated that diversifying beyond responsible pain management and having a beachhead in CNS through the build-out of our ADHD portfolio was an important strategy that was initiated back in 2024. We're well on our way executing on that strategy right now. As we look ahead, we continue to look for other differentiated assets to bring into our portfolio.
是的,謝謝你的問題。你看,正如我們之前討論過的,我們仍致力於執行一套嚴謹的資本配置策略,這包括持續尋找具差異化的資產納入我們的產品組合、償還債務並強化資產負債表,以及以機會性庫藏股回購的形式向股東返還資本。這仍將是我們未來的策略。具體而言,就業務發展而言,我們先前已表示,將業務多元化、超越負責任的疼痛管理,並透過建立我們的ADHD產品組合在CNS建立灘頭堡,是一項重要策略,且早在2024年就已啟動。我們目前正順利推進並執行該策略。展望未來,我們將持續尋找其他具差異化的資產納入我們的產品組合。
What we have previously stated as our criteria still remain the case. Now that we have a strong presence in ADHD, we look for other assets, either within ADHD or in adjacent areas within psychiatry or broader CNS. We have previously also said that outside of these areas, we are open to considering opportunities within rare disease, primarily because of the dynamics of that category. These are medicines that are mostly commercial or just about to be commercial. We look for assets that are in the $300 million to$500 million peak net sales range, which is a sweet spot for us. Long IP, so long durability of revenues, and primarily in the U.S., given the existence of our commercial infrastructure and expertise. The other thing about rare disease is there's a significant amount of expertise within the management team here.
我們先前所述的篩選標準仍然適用。既然我們在ADHD已具備強勢布局,我們會尋找其他資產,可能是在ADHD內部,或是在精神醫學的相鄰領域,或更廣泛的CNS領域。我們先前也提到,在這些領域之外,我們也願意考慮罕見疾病的機會,主要是因為該類別的產業動態。這些藥物多半已商業化或即將商業化。我們尋找峰值淨銷售額約3億至5億美元的資產,這對我們而言是甜蜜點。具備長期IP,也就是收入具長期耐久性,且主要在美國市場,因為我們已有商業化基礎設施與專業能力。另外,罕見疾病方面,管理團隊內部也有相當多的專業經驗。
That is an area where we will look opportunistically. Broadly speaking, our overall approach to business development remains the same and we look forward to continuing to keep you updated as we go.
這是我們會以機會主義方式尋找的領域。總體而言,我們的業務發展整體方法維持不變,我們也期待在推進過程中持續向各位更新。
Operator
Operator
We've reached the end of our question-and-answer session. I would now like to turn the floor back over to Vikram for closing comments.
我們的問答環節到此結束。現在我想把時間交回給Vikram作結語。
Vikram Karnani - President and CEO
Vikram Karnani - President and CEO
Thank you, everyone, for joining the call this morning and for your continued interest in Collegium. We appreciate your time, and we look forward to updating you on our progress. Enjoy the rest of your day. Thank you.
感謝各位今天早上參與本次電話會議,並持續關注Collegium。我們感謝各位撥冗,也期待向各位更新我們的進展。祝各位今天剩下的時間愉快。謝謝。
Operator
Operator
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
今天的電話會議到此結束。您現在可以掛斷電話線。感謝您的參與。