Supernus Pharmaceuticals, Inc. (SUPN) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon, and welcome to Supernus Pharmaceuticals First Quarter 2026 Financial Results Conference Call. (Operator Instructions)

    下午好,歡迎參加 Supernus Pharmaceuticals 2026 年第一季財務業績電話會議。(接線員指示)

  • As a reminder, this conference is being recorded. I would now like to turn the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Supernus Pharmaceuticals. You may begin.

    提醒各位,本次會議將被錄音。現在我想把電話交給 ICR Healthcare 的 Peter Vozzo,他是 Supernus Pharmaceuticals 的投資人關係代表。您可以開始了。

  • Peter Vozzo - Investor Relations

    Peter Vozzo - Investor Relations

  • Thank you. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals First Quarter 2026 Financial Results Conference Call. Today, after the close of the market, the company issued a press release announcing these results. On the call with me today are Supernus' Chief Executive Officer, Jack Khattar; and Chief Financial Officer, Tim Dec.

    謝謝。各位下午好,感謝各位今天參加 Supernus Pharmaceuticals 2026 年第一季財務業績電話會議。今天在收盤後,公司發布新聞稿公布本次業績。今天與我一同出席電話會議的有 Supernus 執行長 Jack Khattar,以及財務長 Tim Dec。

  • Today's call is being made available via the Investor Relations section of the company's website at www.ir.supernus.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information.

    今天的電話會議可透過公司網站 www.ir.supernus.com 的投資人關係專區收聽。在本次電話會議過程中,管理層可能會就未來事件及公司未來表現作出某些前瞻性陳述。這些前瞻性陳述反映 Supernus 對現有趨勢與資訊的目前觀點。

  • Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings. Actual results may differ materially from those projected in these forward-looking statements.

    任何此類前瞻性陳述均非對未來表現的保證,且涉及風險與不確定性,包括公司最新向 SEC 申報文件中「風險因素」章節所述者。實際結果可能與這些前瞻性陳述所預期者存在重大差異。

  • For the benefit of those of you who may be listening to the replay, this call is being held and recorded on May 5, 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws.

    為了方便可能收聽重播的各位,本次電話會議於 2026 年 5 月 5 日舉行並錄音。自那時起,公司可能已就所討論的主題發布其他公告。請參考公司最新新聞稿及目前向 SEC 提交的文件。除非適用證券法另有要求,Supernus 不承擔更新這些前瞻性陳述的任何義務。

  • I'll now turn the call over to Jack.

    現在我把電話交給 Jack。

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Thank you, Peter, and thanks, everyone, for taking the time to join us on today's call. Supernus's first quarter results reflect a strong start to the year, including a 56% year-over-year increase in combined revenues of our growth products and an 11% year-over-year increase in adjusted operating earnings.

    謝謝你,Peter,也感謝各位撥冗參加今天的電話會議。Supernus 第一季的業績反映今年強勁的開局,包括我們成長型產品合計營收年增 56%,以及調整後營業利益年增 11%。

  • Starting with ONAPGO. During the first quarter, ONAPGO generated net sales of $8.4 million, reflecting a partial benefit from the resumption of new patient initiations in February 2026. We are pleased with the rebound in the business since we resumed patient initiations with some of the metrics in March reaching or even exceeding levels achieved before the supply constraints.

    先從 ONAPGO 談起。第一季 ONAPGO 淨銷售額為 840 萬美元,反映 2026 年 2 月恢復新病患啟動所帶來的部分效益。我們對恢復病患啟動後業務的回升感到滿意,3 月的部分指標已達到甚至超過供應受限前的水準。

  • For instance, prescriptions in March reached 463, exceeding the level reached in October 2025 before the supply constraints. Also, the number of prescribers in a single month with shipments to patients increased in March to the highest level since the launch of the product.

    例如,3 月處方量達到 463 張,超過 2025 年 10 月(供應受限前)所達到的水準。此外,單月有對病患出貨的開立處方醫師數在 3 月增加至產品上市以來的最高水準。

  • Overall, more than 645 prescribers have submitted approximately 2,200 enrollment forms since the launch of the product through the end of April '26. We are also pleased with the progress with the second supplier on ONAPGO. We expect regulatory submission to the FDA in the third quarter of this year with potential approval before midyear 2027.

    整體而言,自產品上市至 2026 年 4 月底,已有超過 645 位開立處方醫師提交約 2,200 份登記表。我們也對 ONAPGO 第二供應商的進展感到滿意。我們預期將於今年第三季向 FDA 提交法規申請,並有機會在 2027 年年中之前獲得核准。

  • Switching now to ZURZUVAE. Supernus reported $27.6 million in collaboration revenues in the first quarter. Full first quarter 2026 U.S. sales of ZURZUVAE as reported by Biogen increased approximately 100% compared to the same period in 2025. In the first quarter of 2026, ZURZUVAE saw strong growth of 82% and 73% in written prescriptions and number of prescribers, respectively, compared to the same period last year.

    接著談 ZURZUVAE。Supernus 第一季認列 2,760 萬美元的合作收入。Biogen 所報告的 ZURZUVAE 2026 年第一季美國銷售額,較 2025 年同期約增加 100%。2026 年第一季,ZURZUVAE 的開立處方量與開立處方醫師數,分別較去年同期強勁成長 82% 與 73%。

  • Since launch, 85% of the prescriptions have come from repeat prescribers and more than 29,000 patients have been treated with ZURZUVAE.

    自上市以來,85% 的處方來自重複開立處方的醫師,且已有超過 29,000 名病患接受 ZURZUVAE 治療。

  • Regarding Qelbree in the first quarter and as reported by IQVIA, prescriptions grew by 19% compared to the same period last year, outpacing the 10% growth in the total ADHD market. Net sales of $78 million represented a strong 20% increase over the first quarter last year.

    關於 Qelbree,第一季根據 IQVIA 的資料,處方量較去年同期成長 19%,優於整體 ADHD 市場 10% 的成長。淨銷售額為 7,800 萬美元,較去年第一季強勁成長 20%。

  • Despite typical first quarter headwinds, Qelbree's growth continues to be solid and is coming from both patient populations with adult prescription growth of 27% and pediatric prescription growth of 15%. In addition, the total quarterly number of prescribers for Qelbree reached a high of approximately 43,000 with adult prescribers for the first time surpassing the number of pediatric prescribers.

    儘管第一季通常面臨逆風,Qelbree 的成長仍然穩健,且來自兩類病患族群:成人處方成長 27%,兒科處方成長 15%。此外,Qelbree 單季開立處方醫師總數創新高,約達 43,000 人,且成人開立處方醫師數首次超過兒科開立處方醫師數。

  • Switching now to GOCOVRI. For the first quarter of 2026, net sales reached $35.2 million, increasing by 15% compared to the same quarter in 2025. Total number of prescriptions grew by 7% in the first quarter of 2026 compared to the same period last year.

    接著談 GOCOVRI。2026 年第一季淨銷售額達 3,520 萬美元,較 2025 年同季成長 15%。2026 年第一季處方總量較去年同期成長 7%。

  • Moving on to R&D, the follow-on Phase IIb randomized, double-blind, placebo-controlled trial with SPN-820 in approximately 200 adults with major depressive disorder is ongoing. This study will examine the safety and tolerability of SPN-820 and its efficacy at a dose of 2,400 milligram given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy.

    接下來談研發(R&D),SPN-820 的後續第二期 b(Phase IIb)隨機、雙盲、安慰劑對照試驗正在進行中,對象約為 200 名重度憂鬱症成人患者。本研究將評估 SPN-820 的安全性與耐受性,以及其在每週間歇性給藥兩次、每次 2,400 毫克劑量下,作為現行基礎抗憂鬱治療之輔助治療的療效。

  • Our Phase IIb randomized, double-blind, placebo-controlled study of SPN-817 is also ongoing with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes 3-milligram and 4-milligram twice daily doses. And for SPN-443, our novel stimulant ADHD product candidate, we expect to initiate a Phase I single ascending and multiple ascending dose study in adult healthy volunteers in the second half of 2026.

    我們針對 SPN-817 的第二期 b(Phase IIb)隨機、雙盲、安慰劑對照研究也正在進行中,目標收案約 258 名治療抗性局灶性癲癇成人患者。本試驗採用每日兩次 3 毫克與 4 毫克劑量。至於 SPN-443(我們新型的興奮劑 ADHD 產品候選藥物),我們預期將於 2026 年下半年在健康成人志願者中啟動第一期(Phase I)單次遞增與多次遞增劑量研究。

  • Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates.

    最後,企業發展仍將是我們的首要重點之一;我們將尋求更多策略性機會,透過可帶來營收的產品或後期研發管線產品候選藥物,進一步強化我們在中樞神經系統(CNS)領域的未來成長與領導地位。

  • With that, I will now turn the call over to Tim.

    接下來,我把電話交給 Tim。

  • Timothy Dec - Chief Financial Officer, Senior Vice President

    Timothy Dec - Chief Financial Officer, Senior Vice President

  • Thank you, Jack. Good afternoon, everyone. As I review our first quarter 2026 results, please refer to today's press release and 10-Q that was filed earlier today. We achieved total revenue of $207.7 million for the first quarter of 2026, an increase of 39% compared to the same quarter last year. Total revenues were comprised of revenues from our commercial products, including ZURZUVAE collaboration revenues and royalty, licensing and other revenues.

    謝謝你,Jack。各位下午好。在我回顧 2026 年第一季業績時,請參考今天發布的新聞稿以及今天稍早提交的 10-Q。我們 2026 年第一季總營收為 2.077 億美元,較去年同季成長 39%。總營收包含我們商業化產品的收入(包括 ZURZUVAE 的合作收入與權利金),以及權利金、授權及其他收入。

  • Revenues from commercial products increased to $178 million, a 26% increase compared to the same quarter last year. This increase in revenues from commercial products was primarily due to the increase in net sales of our growth products, Qelbree, GOCOVRI and ONAPGO, as well as the addition of collaboration revenues from ZURZUVAE.

    商業化產品收入增加至 1.78 億美元,較去年同季成長 26%。商業化產品收入的增加主要來自我們成長型產品 Qelbree、GOCOVRI 與 ONAPGO 淨銷售額的提升,以及新增來自 ZURZUVAE 的合作收入。

  • In addition, revenues from royalty and licensing and other revenues were $29.3 million. This includes $20 million of licensing revenues related to the achievement of a commercial milestone under the company's collaboration agreement with Shunovi.

    此外,權利金、授權及其他收入為 2,930 萬美元。其中包括與公司與 Shunovi 的合作協議下達成一項商業里程碑所相關的 2,000 萬美元授權收入。

  • For the first quarter of 2026, combined R&D and SG&A expenses were $164.6 million as compared to $116.9 million for the same quarter last year. This increase was primarily due to an increase in SG&A expenses associated with the collaboration agreement with Biogen.

    2026年第一季,研發(R&D)與銷售、一般及行政(SG&A)費用合計為1.646億美元,較去年同期的1.169億美元增加。此增幅主要來自與Biogen合作協議相關的SG&A費用增加。

  • Operating loss on a GAAP basis for the first quarter of 2026 was $8.3 million as compared to an operating loss of $10.3 million for the same quarter last year. The change was primarily due to higher revenues, partially offset by an increase in SG&A expenses associated with the collaboration agreement with Biogen. GAAP net loss was $2.3 million for the first quarter of 2026 or net loss per share of $0.04 compared to GAAP net loss of $11.8 million or $0.21 per diluted share in the same period last year.

    按GAAP基準計,2026年第一季營業虧損為830萬美元,較去年同期營業虧損1,030萬美元收窄。變動主要由於營收較高,但部分被與Biogen合作協議相關的SG&A費用增加所抵銷。GAAP淨虧損為230萬美元,或每股淨虧損0.04美元;相較之下,去年同期GAAP淨虧損為1,180萬美元,或每股稀釋後虧損0.21美元。

  • On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration and depreciation, adjusted operating earnings for the first quarter of 2026 was $28.7 million compared to $25.9 million in the same quarter of last year.

    按非GAAP基準(不含無形資產攤銷、股份基礎給付、或有對價及折舊),2026年第一季調整後營業利益為2,870萬美元,較去年同期的2,590萬美元增加。

  • As of March 31, 2026, the company had approximately $384 million in cash, cash equivalents and marketable securities compared to $309 million as of December 31, 2025. This increase was primarily due to cash generated from operations, the timing of Medicaid payments and the Shunovi-related commercial milestones. The company's balance sheet remains strong with no debt and significant financial flexibility for potential M&A and other growth opportunities.

    截至2026年3月31日,公司持有約3.84億美元的現金、約當現金及有價證券,較2025年12月31日的3.09億美元增加。此增加主要來自營運產生的現金、Medicaid付款時點,以及與Shunovi相關的商業里程碑款。公司資產負債表仍然強健,無負債,並具備顯著的財務彈性,以因應潛在的併購(M&A)及其他成長機會。

  • Now turning to guidance. For full year 2026, the company reiterates its financial guidance for total revenues, combined R&D and SG&A expenses and non-GAAP operating earnings. As such, we expect total revenues to range from $840 million to $870 million, comprised of commercial product revenues and royalty and licensing revenues. For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million to $650 million. Overall, we expect full year operating earnings in the range of $0 to $30 million.

    接下來談指引。針對2026年全年,公司重申其對總營收、研發與SG&A費用合計,以及非GAAP營業利益的財務指引。因此,我們預期總營收將介於8.40億至8.70億美元之間,包含商業產品營收以及權利金與授權營收。2026年全年,我們預期研發與SG&A費用合計將介於6.20億至6.50億美元之間。整體而言,我們預期全年GAAP營業利益介於0至3,000萬美元之間。

  • And finally, we expect non-GAAP operating earnings to range from $140 million to $170 million. Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP.

    最後,我們預期非GAAP營業利益將介於1.40億至1.70億美元之間。請參閱本次電話會議前發布的財報新聞稿,其中列示GAAP與非GAAP之間各項調節項目的區間。

  • With that, I will now turn the call back over to the operator for Q&A. Operator?

    接下來,我把電話交回給接線員進行問答。接線員?

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Andrew Tsai, Jefferies.

    Jefferies的Andrew Tsai。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • Specifically on ONAPGO, it's great to see that you have 2,200 start forms now, up from 1,800 in January. Ultimately, what percentage of those patients or start forms do you think you will be ultimately converted to a paying patient? And can you remind us how many weeks it can take from a start form to a paying patient, how long that could take? Thank you.

    具體就ONAPGO而言,很高興看到你們目前已有2,200份啟動表單(start forms),較1月的1,800份增加。最終你們認為其中有多少比例的病患或啟動表單,會轉換為實際付費病患?另外也請提醒我們,從提交啟動表單到成為付費病患,通常需要多少週、可能要多久?謝謝。

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. On an average, from the time you get a form until you have a shipment, I mean, you could lose somewhere in the 40% to 45% of these patients in the process for all kind of reasons. Whether it's change in the medical condition of the patient over time, the insurance issue, any of these reasons eventually or just lack of response sometimes because a lot of these forms don't have all the completed information.

    是的。平均而言,從收到表單到完成出貨的這段時間,在流程中你可能會因各種原因流失約40%到45%的病患。原因可能包括病患的醫療狀況隨時間改變、保險問題等;此外有時也可能只是缺乏回覆,因為很多表單資訊並未完整填寫。

  • So, you're calling the patient and trying to get more information from them to be able to process it. Sometimes you just don't call that.

    因此你們會致電病患,嘗試取得更多資訊以便處理。有時候就是聯絡不上。

  • And then as far as the hearing of time, I mean, it could take several weeks. As we go through this process over time, of course, we're always looking at different bottlenecks and try to streamline and improve the process. But it is several weeks for somebody to have the form submitted until finally they get the product shipped.

    至於所需時間,我的意思是,可能需要好幾週。隨著我們持續推進這個流程,當然也一直在找出不同的瓶頸,並嘗試精簡與改善流程。但從有人提交表單到最終產品出貨,確實需要數週時間。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • And so following up on that, to get to your ONAPGO guidance, the high end of $75 million, mathematically, you're going to be needing more than 700 patients on therapy. So, if I did 2,200, 50% conversion, that would be over 1,000 patients potentially on ONAPGO. So, it looks like you can get there.

    那接著追問,為了達到你們對ONAPGO的指引,上緣7,500萬美元,從數學上看,你們需要超過700位病患接受治療。所以如果我用2,200份、50%的轉換率來算,可能就會有超過1,000位病患使用ONAPGO。看起來你們是有機會達標的。

  • So, can you remind us how many patients are still on ONAPGO today? And when could you expect most of those kinds of hypothetical patients to get on drug? Should it be within the next three to six months then?

    那你們能否提醒我們,目前仍在使用ONAPGO的病患大約有多少?以及你們預期這些假設中的病患大多會在何時開始用藥?是否會在接下來三到六個月內?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. I mean the high end of our guidance is the $70 million. You're thinking about it the right way. Yes, I mean, that could translate to somewhere around on an average, about 700 patients that you need to have around 700 patients throughout the whole year, clearly to give you the $70 million in sales. The thing is with the 2,200, you have to remember, that's a number that is launched to date.

    是的。我的意思是,我們指引的上緣是7,000萬美元。你的思考方向是對的。是的,這大致可換算為平均而言,你需要全年維持大約700位病患,才能明顯支撐7,000萬美元的銷售額。但關於2,200份,你要記得,那是截至目前為止自上市以來的累計數字。

  • That is not 2,200 in 2026, obviously, right? So, it will be interesting to see how many we generate this year and how many out of the 20 or whatever is left actually out of the 2,200. If we look at the backlog right now, we are probably somewhere around 570, give or take, patients in the queue versus last time we talked it was around 700. So, we are going through the backlog, and we're actually improving as time goes on. We're improving our number of patients that are being processed per week.

    顯然那不是2026年單年度就有2,200份,對吧?所以今年我們會新增多少,以及在2,200份之中實際還剩下多少(不論是20份或其他數量)仍待轉換,會很值得觀察。如果看目前的待處理量(backlog),我們大概有約570位(上下浮動)病患在隊列中;上次我們談時大約是700位。所以我們正在消化待處理量,而且確實隨時間推進在改善。我們每週可處理的病患數也在提升。

  • Remember, I mean, we just restarted the whole machinery, so to speak, or the whole process started middle to end of February, so to speak. So it's taken us March, and we've been very happy with the progress the team has made through March, really getting us to very high levels.

    請記得,我的意思是,我們等於是重新啟動整套機制,或者說整個流程大約在2月中下旬才重新開始。因此我們花了3月的時間,而我們對團隊在3月取得的進展非常滿意,確實把水準拉到非常高。

  • As I mentioned in my previous remarks, even exceeding performance metrics, exceeding those that were before the supply constraint. So things are really on the uptick. We're pretty happy with the rebound in the business, how we're processing these forms, how many of these forms we're able to translate into real patients and real shipments.

    如我先前所提,甚至超越了績效指標,也超過了供應受限之前的水準。所以整體確實在走升。我們對業務反彈感到相當滿意,包括我們如何處理這些表單、以及能把多少表單轉化為實際病患與實際出貨。

  • But we maintained the guidance, of course, because we would like to see another full quarter. So Q1, as I mentioned in my remarks, was really a partial quarter. It wasn't really a full quarter, right? So let's see a full quarter and how quickly we can go through this backlog. In the first quarter, we only really benefited from March, so to speak.

    不過我們仍維持指引,當然是因為我們希望再看到完整的一個季度。所以第一季,如我在談話中提到的,其實是部分季度。它並不算真正完整的一季,對吧?因此讓我們看看完整一季的表現,以及我們能多快消化這些待處理量。第一季我們基本上只真正受惠於3月。

  • February was very partial, very minimal initiations in January. And therefore, it's not a true reflection of a full quarter with the business rebounding. But we're very happy with how things are moving along across several metrics with the demand continuing to be strong, as you pointed out, with the 2,200 forms, but also with the way the team is processing these forms and try to minimize the drop-offs and the losses throughout the process. But we feel still pretty good, obviously, and that's why we didn't change the guidance. So still pretty good about the $45 million to $70 million guidance on.

    2月只是一小部分,1月的啟動量也非常少。因此這並不能真實反映業務反彈下的完整季度表現。但我們對多項指標的進展非常滿意:如你所指出,需求持續強勁(2,200份表單);同時團隊處理表單的方式也在改善,並努力把流程中的流失與掉隊降到最低。但我們仍然覺得狀況相當不錯,顯然這也是我們沒有調整指引的原因。所以我們對4,500萬至7,000萬美元的指引仍然相當有信心。

  • Andrew Tsai - Analyst

    Andrew Tsai - Analyst

  • Very good. Thank you.

    非常好。謝謝。

  • Operator

    Operator

  • David Amsellem, Piper Sandler.

    David Amsellem,Piper Sandler。

  • Unidentified Participant_1 - Analyst

    Unidentified Participant_1 - Analyst

  • This is Alex on for David. First one, sort of jumping off of the last question regarding the guidance range for ONAPGO and the assumptions to get to the top end of the range and the number of patients.

    我是代替 David 的 Alex。第一個問題,延續上一題關於 ONAPGO 指引區間,以及要達到區間上緣所需的假設與病患人數。

  • Can you maybe speak to what you're seeing in terms of patient persistence for patients who are getting drug? And then secondly, regarding ZURZUVAE, can you maybe speak to how you're thinking about the growth runway of the product?

    你能否談談你們觀察到正在用藥的病患在治療持續性(persistence)方面的情況?第二個,關於 ZURZUVAE,你能否談談你們如何看待該產品的成長跑道?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. Regarding ZURZUVAE, as I mentioned in my remarks, I mean, really pleased with the performance of the product. If you look at the true fundamental metrics as far as prescriptions, number of prescribers, I mean we're really broadening the prescriber base, and we've been very successful with our partner, Biogen, in doing that. And of course, the prescriptions grew a very healthy 82% in the quarter versus last year. So, as far as penetration, we're still in the real early innings on this product, as we mentioned previous quarters.

    是的。關於 ZURZUVAE,如同我在發言中提到的,我們對產品表現非常滿意。如果看真正的基本面指標,例如處方量、開立處方的醫師人數,我們確實正在擴大開方醫師基礎,並且與合作夥伴 Biogen 在這方面非常成功。當然,本季處方量相較去年同期健康成長了 82%。因此,就滲透率而言,正如我們在前幾季提到的,這個產品仍處於非常早期的階段。

  • The potential of the product is fairly big. Every year, you have around 500,000 women who experience these symptoms. And as I mentioned again earlier, only 29,000 patients have been treated with ZURZUVAE since launching, and we're into year three right now. So, we have a long way to go with ZURZUVAE, and we're very happy with the momentum of the brand. And of course, we also started significant efforts on the DTC side and other programs.

    這個產品的潛力相當大。每年大約有 50 萬名女性會出現這些症狀。而且如我先前再次提到,自上市以來,接受 ZURZUVAE 治療的病患只有 29,000 人,而我們現在正進入第三年。所以,ZURZUVAE 還有很長的路要走,我們對品牌動能非常滿意。當然,我們也在 DTC(直接面向消費者)端及其他計畫上投入了顯著的努力。

  • So, we have pretty nice expectations of growth from the product. Regarding, if I understood your question on ONAPGO, is it really the patient profile and the kind of patients we're getting on ONAPGO. It looks like we're starting to get some feel for who is that patient. We don't have a complete full picture yet because as you would imagine, with a new product, it evolves over time. But some of the early indicators, patients tend to be more on the younger side as far as age and/or the disease, meaning they haven't been diagnosed for a long, long time.

    因此,我們對該產品的成長有相當不錯的期待。至於 ONAPGO,如果我理解你的問題,是關於病患輪廓以及我們目前讓哪些類型的病患使用 ONAPGO。看起來我們開始對「那位病患」是誰有一些感覺。我們還沒有完整全貌,因為如你所想,新產品會隨時間演變。但一些早期指標顯示,病患在年齡上往往較年輕,且/或就疾病而言,代表他們被診斷的時間並不長。

  • They tend to be active. They tend to really be looking for -- specifically from a physician perspective, they're looking for something different than a levodopa/carbidopa. So that's the kind of patient profile that seems to be emerging right now as we speak on the ONAPGO side.

    他們通常很活躍。而且他們確實在尋找——特別是從醫師角度——不同於左旋多巴/卡比多巴的治療選項。所以,這就是目前在 ONAPGO 端我們所看到正在浮現的病患輪廓。

  • Unidentified Participant_1 - Analyst

    Unidentified Participant_1 - Analyst

  • And then what are you seeing in terms of patient persistence for ONAPGO?

    那麼,就 ONAPGO 而言,你們在病患治療持續性方面看到什麼情況?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. It's a little bit too early for us because we got the disruption in the supply and so forth. And actually, we were pretty happy with the refills and how many patients stayed with us around the time of the supply constraint. So, we do have dropouts that are fairly consistent with the clinical study, maybe a little bit more. So, we're watching it very carefully.

    是的。現在對我們來說還有點太早,因為我們遇到供應中斷等等情況。其實,在供應受限期間,我們對續配(refills)以及有多少病患持續使用我們的產品感到相當滿意。因此,我們確實有一些中止治療(dropouts),其比例與臨床研究相當一致,可能略高一些。所以我們正在非常密切地觀察。

  • Typically, these dropouts occur when you have the titration and how well the titration has happened, because with apomorphine, you have to do titration very slowly, starting with lower doses, you can jump in pretty quickly into high doses on apomorphine.

    一般而言,這些中止多發生在劑量滴定(titration)期間,以及滴定進行得是否順利;因為使用阿撲嗎啡(apomorphine)時必須非常緩慢地滴定,從較低劑量開始,你不能很快就跳到阿撲嗎啡的高劑量。

  • So, depending on how that is happening and how the patient is responding to that, once they go through that titration, typically, they tend to stay with it and be pretty happy and pleased with it. And that's been the experience that historically has been in Europe.

    因此,取決於滴定的進行方式以及病患對此的反應;一旦他們度過滴定期,通常就會持續使用,並且對療效相當滿意。這也是過去在歐洲的歷史經驗。

  • Unidentified Participant_1 - Analyst

    Unidentified Participant_1 - Analyst

  • Thank you

    謝謝

  • Operator

    Operator

  • Kristen Kluska, Cantor.

    Kristen Kluska,Cantor。

  • Kristen Kluska - Research Analyst

    Kristen Kluska - Research Analyst

  • Congrats on a great start to the calendar year 2026 here. Just on ONAPGO, as we think about the mid-2027 approval, how are you working with your partners out in Europe thinking about what the demand might look like in 2027 onwards to be able to work with them to meet that criteria?

    恭喜 2026 日曆年度有個很好的開局。關於 ONAPGO,當我們思考 2027 年年中核准時,你們如何與歐洲的合作夥伴合作、評估 2027 年及之後的需求可能會是什麼樣子,以便能與他們合作來符合該標準?

  • And then when we think about the US right now in terms of the patients that are getting on therapy, given that these capacity strains are still there to an extent, are you seeing that physicians are prioritizing certain patients over others, just knowing that they might not be able to get their hands on enough supply for all of the patients they want to treat?

    另外,就目前美國而言,考量到產能吃緊在某種程度上仍然存在,是否看到醫師會優先讓某些病患使用、而非其他病患?因為他們知道可能無法取得足夠供應來治療所有想治療的病患。

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. Regarding the last question, I mean, we haven't detected anything specific because of the previous supply constraint that they're using the product on a different patient or one patient versus another. So we can't clear -- at this point, I can't answer that question specifically.

    是的。關於最後一個問題,我們並未因先前的供應受限而偵測到任何特定情況,顯示他們會把產品用在不同類型的病患、或偏向某一位病患而非另一位。所以我們無法明確——就目前而言,我無法具體回答那個問題。

  • But overall, regarding your other part of the question on the supplier and 2027 demand and so forth, I mean, we do have a plan with our second supplier and also the current supplier, because depending on the timing as to when the second supplier comes in 2027, to meet the demand of 2027, certainly.

    但整體而言,關於你問題的另一部分,也就是供應商與 2027 年需求等等,我們確實與第二供應商以及目前供應商都有規劃;因為取決於第二供應商在 2027 年何時導入,來滿足 2027 年的需求,這點當然是確定的。

  • And that's really how we align all that and lay over the current supply, the second supply, and look at the demand in total and make sure that we are covered from either one of them, and/or both at the same time.

    而這就是我們如何把所有這些對齊:把現有供應、第二供應疊加起來,並整體檢視需求,確保我們能由其中一方,和/或 同時由兩方供應來涵蓋需求。

  • So the second supplier also, I should say, has multiple of the capacity that the current supplier has. So once the second supplier is online, we will feel pretty good about 2027. And I did mention once earlier, we're even working on another supplier as a backup as well in addition to the second supplier.

    另外我也要說,第二供應商的產能是目前供應商的好幾倍。因此,一旦第二供應商上線,我們對 2027 年會相當有信心。而且我之前也提過,我們也在另外開發一個供應商作為備援,除了第二供應商之外。

  • So we're giving up a lot of the backups from a supply perspective to make sure we meet the demand, not only in 2027, of course, and several years beyond that.

    所以,從供應角度來看,我們正在建立多層備援,以確保能滿足需求,不僅是 2027 年,當然也包括之後好幾年。

  • Kristen Kluska - Research Analyst

    Kristen Kluska - Research Analyst

  • And then on ZURZUVAE, how are you seeing adoption in line with the prescribing? Meaning like are you seeing some patients who are coming back for a second cycle of it? What percent of patients are completing the 14-day treatment course? And I guess I'm just -- what I'm trying to allude to is like how close to the recommendations are you seeing this real-time?

    另外關於 ZURZUVAE,你們看到的採用情況與開立處方的情況一致嗎?也就是說,你們是否看到有些病患回來進行第二個療程?有多少比例的病患完成 14 天的療程?我想——我試圖暗示的是,你們即時看到的實際使用情況,與建議用法有多接近?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. ZURZUVAE typically, I mean, the people stick with the 14-day therapy. It is a short-term therapy to start with. So, it's unlikely that people are going to quit on it. So -- and especially when they start seeing the benefit early, pretty quickly by day three.

    是的。ZURZUVAE 通常——我的意思是,人們會完成 14 天療程。它本來就是短期療法。所以,人們不太可能中途停止。而且——特別是當他們在很早期、很快在第 3 天就開始看到效益時。

  • So that obviously even reinforces it and encourages them to finish the 14-day therapy. And with ZURZUVAE, obviously, it's a very different kind of business. You don't have refills. Of course, unless mom gets pregnant again, and it's another year or cycle, so to speak, and she happens to have also PPDs with the second pregnancy. But normally, there is no relapse or anything like that for them to come back and cycle through it again.

    所以這顯然會進一步強化並鼓勵他們完成 14 天療程。而且對 ZURZUVAE 來說,顯然這是非常不同的商業模式。你不會有續配。當然,除非媽媽再次懷孕,到了另一年或另一個週期(這麼說),而且她在第二次懷孕也剛好出現 PPD(產後憂鬱)症狀。但通常不會有復發或類似情況,讓她們回來再走一次療程。

  • Kristen Kluska - Research Analyst

    Kristen Kluska - Research Analyst

  • Thanks, Jack.

    謝謝,Jack。

  • Operator

    Operator

  • Vishwesh Shah, TD Cowen.

    Vishwesh Shah,TD Cowen。

  • Vishwesh Shah - Analyst

    Vishwesh Shah - Analyst

  • Congrats to you guys on another great quarter. So on Qelbree, what are you seeing in terms of some of the adoption trends right now? You commented on some of the adults trying out Qelbree. And so is that the shift in focus now? Or what do you think will drive growth in adoption through the rest of the year?

    恭喜各位又交出一個很棒的季度表現。關於 Qelbree,目前在採用趨勢方面你們看到了哪些變化?你提到有一些成人正在嘗試使用 Qelbree。所以現在重點是否正在轉向成人?或者你認為今年剩餘時間,將由什麼因素推動採用成長?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. We're actually very excited on Qelbree and what we really saw in the first quarter, and it's a pretty interesting dynamic in a very positive way, specifically in the adult segment of the market. So, there are several things that I would pretty much emphasize on Qelbree. Clearly, the adult growth has now outpaced pediatric growth for a number of quarters, actually. This is not the first quarter it happens.

    是的。我們其實對 Qelbree 非常興奮;而我們在第一季看到的情況,是一個相當有趣、且非常正向的動態,特別是在成人市場區隔。所以,關於 Qelbree,有幾點我會特別強調。很明顯地,成人端的成長其實已經連續好幾個季度超過兒科端的成長。這並不是第一次發生。

  • We're very pleased with the fact that the adult continues to grow because it is the biggest segment of the market, naturally, and you want to penetrate that segment as much as possible and be very successful in it for the continued future growth of the product.

    我們對成人端持續成長感到非常滿意,因為成人自然是市場中最大的區隔;你會希望盡可能滲透這個區隔,並在其中取得成功,以支撐產品未來持續的成長。

  • And for example, I'll give you another metric. If you look at new prescriptions in the first quarter of 2026, adults again grew by 27%. This is in new prescriptions, not total prescriptions. And these continue to be strong, also with 16% growth.

    再舉一個指標。如果你看 2026 年第一季的新處方,成人端再次成長了 27%。這是新處方,不是總處方量。而這些表現仍然強勁,同時也有 16% 的成長。

  • So, the interesting thing is, I mean, we have been emphasizing adult. We've been putting a little bit more emphasis on adults, especially when we are out of the back-to-school season, because we rotate, of course, the emphasis, and we rotate the resources in the back-to-school season. Clearly, we put more of a push on pediatrics, but we don't neglect adults.

    所以,有趣的是,我的意思是,我們一直在強調成人端。我們確實在成人端投入了更多一些的重點,特別是在開學季結束之後,因為我們當然會輪動重點,也會在開學季輪動資源。很明顯地,我們會更用力推動兒科端,但我們不會忽略成人端。

  • And then when we are out of the back-to-school season, we try to take advantage of the growth in the adult market because from a market point of view, in the total market, adult also continues to be the fastest segment that is growing. So, we want to take advantage of that as well.

    而當我們離開開學季之後,我們會試著把握成人市場的成長,因為從整體市場角度來看,成人端也仍然是成長最快的區隔。所以,我們也希望能夠把握這一點。

  • So we're pretty pleased with that. And as I mentioned earlier, this is for the first time now, a number of prescribers in the adult population has surpassed our number of prescribers in pediatrics, and really jumped pretty quickly, noticeably in this first quarter.

    因此我們對此相當滿意。而且如我先前提到,這是第一次,成人族群的開立處方醫師數量已經超過兒科端的開立處方醫師數量,而且在第一季確實相當快速、明顯地跳升。

  • So, we were very pleased to see that. Also, from the patient perspective, what's really happening, which we're encouraged about also, is the fact that the patient profile, and you would expect that typically in the brand, as it stays in the market for a while, and now we're into year 6, pretty much in May, we're in year six of the brand. The patient profile is broadening.

    所以,我們很高興看到這點。另外,從病患角度來看,真正正在發生、也讓我們受到鼓舞的是:病患輪廓正在擴大;而你也會預期,一個品牌在市場上存在一段時間後通常會出現這種情況。現在我們在 5 月基本上進入第 6 年,也就是品牌第六年。病患輪廓正在變得更廣。

  • So, it's not anymore some of the early low-hanging fruit that you're getting basically. What I mean by that is you're really getting a much broader type of patients into the franchise, and physicians are starting to think of so many different types of patients and needs out there that Qelbree could be the answer for.

    所以,不再只是早期那些比較容易取得的「低垂果實」。我的意思是,你真的會看到更多元的病患類型進入這個產品體系,而醫師也開始想到外面有各式各樣不同類型的病患與需求,Qelbree 可能就是其中的解方。

  • For example, patients who, of course, are intolerant to stimulants, something interesting emerging is patients are really looking for all-day coverage. And a lot of the adults, we know it as a fact, when they use stimulants, even if they use controlled-release stimulants, so many of them have to supplement at the end of the day with an immediate-release stimulant to give them that full day coverage. But with Qelbree, you don't need any of that.

    例如,當然包括對興奮劑不耐受的病患;另外一個有趣的新趨勢是,病患真的在尋求「全天候」的覆蓋。而我們確知,許多成人在使用興奮劑時,即使使用的是緩釋型興奮劑,很多人仍需要在一天結束時再補上一劑速放型興奮劑,才能達到整天的覆蓋。但使用 Qelbree 就不需要這樣做。

  • You just need to take it once a day, whether at night or in the morning, and it will give you full-day coverage. So, I think physicians, over time, as they have more experience with the product, are finding more ways to use Qelbree as a true solution for a lot of their patients. And then, of course, those who are partial responders to stimulants, I mean, stimulants work, but they don't work for everybody. And sometimes we forget that. And a lot of physicians are using it for those partial responders to stimulants.

    你只需要一天服用一次,不論是晚上或早上,就能提供全天覆蓋。所以我認為,隨著時間推進、醫師對產品的使用經驗增加,他們正在找到更多方式,把 Qelbree 作為許多病患的真正解決方案。另外,當然也包括對興奮劑僅部分反應者;我的意思是,興奮劑有效,但不是對每個人都有效。而我們有時會忘記這點。很多醫師會把它用在那些對興奮劑僅部分反應的病患身上。

  • And then the complex ADHD. And of course, that comes with time as we generate more data around the product and the potential use of the product with comorbidities and so forth, more and more patients are starting to understand that Qelbree could really play a role with these patients who have that what we call complex ADHD because of the serotonin modulation and the very unique multimodal activity and pharmacodynamic profile of Qelbree. So, a lot of very exciting things continue to happen there and really a lot of momentum in the brand.

    還有複雜型 ADHD。當然,這需要時間;隨著我們針對產品以及其在共病等情境下的潛在使用累積更多數據,越來越多病患開始理解,Qelbree 其實可以在我們所稱的「複雜型 ADHD」病患中扮演角色,這與 Qelbree 的血清素調節、以及非常獨特的多重作用機制與藥效動力學特徵有關。所以,那裡仍持續發生許多令人振奮的事情,品牌動能也非常強。

  • Vishwesh Shah - Analyst

    Vishwesh Shah - Analyst

  • And then on ONAPGO, what dynamics are you seeing between patients opting for ONAPGO versus VYALEV? So, what kind of competitive dynamics are you seeing there?

    另外關於 ONAPGO,在病患選擇 ONAPGO 相較於 VYALEV 之間,你們看到了哪些動態?也就是說,你們在那裡看到了什麼樣的競爭動態?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. I mean I mentioned very quickly, I mean, the first cutoff typically is patients who have been on levodopa/carbidopa and the physician may not see any incremental additional benefit for the patient to stay on that drug. And therefore, they could potentially benefit more from something else, a different drug, different mechanism, different molecule, and therefore, they would go and turn to something like ONAPGO.

    是的。我的意思是,我很快提到過,第一個分界點通常是:病患已經使用左旋多巴/卡比多巴,而醫師可能看不到病患繼續使用該藥物還能帶來任何額外的增量效益。因此,他們可能會更受益於其他選項——不同的藥物、不同的機轉、不同的分子——於是就可能轉向像 ONAPGO 這樣的治療。

  • And vice versa, if the physician feels that the patient may still benefit from some levodopa/carbidopa maybe for another year or two and then they might consider ONAPGO, so they might go towards something like VYALEV or something else instead of ONAPGO. So that's the first type of thing that obviously a physician is assessing.

    反過來,如果醫師認為病患可能仍能從左旋多巴/卡比多巴中獲益,也許再用一到兩年,之後才會考慮 ONAPGO,那他們可能就會先選擇像 VYALEV 或其他方案,而不是 ONAPGO。所以這是醫師顯然會先評估的第一件事。

  • And then interesting from our research, it looks like our patient profile tends to be on the younger side, the active side earlier in the disease versus the VYALEV patient tends to be a little bit more on the older side. We're trying to dig into deeper into this to really understand what's behind some of that.

    另外,從我們的研究來看,有趣的是,我們的病患輪廓看起來偏年輕一些、也更偏向在疾病較早期且較活躍的族群;相較之下,VYALEV 的病患似乎偏年長一些。我們正在更深入地探究,以真正理解其中一些差異背後的原因。

  • Some of the folks who may need and have very difficult time at night, they may choose VYALEV because you have to put VYALEV through the night. With our product, I mean, you get pretty much a similar efficacy on reducing off time, but you don't have to wear it 24 hours. But with VYALEV, you have to wear it 24 hours to give you pretty much similar type of efficacy.

    有些人在夜間需求很高、且夜間狀況非常棘手,他們可能會選擇 VYALEV,因為你必須在夜間也使用 VYALEV。而使用我們的產品,我的意思是,你在減少 off time 方面基本上能得到相近的療效,但你不需要 24 小時配戴。但使用 VYALEV,你必須 24 小時配戴,才能提供基本上相近類型的療效。

  • So, there are different patients that are emerging that could be really different candidates for either ONAPGO or VYALEV.

    所以,正在浮現出不同類型的病患,他們可能分別更適合 ONAPGO 或 VYALEV。

  • Vishwesh Shah - Analyst

    Vishwesh Shah - Analyst

  • Got it. Thank you very much.

    了解。非常感謝。

  • Operator

    Operator

  • Annabel Samimy, Stifel.

    Annabel Samimy,Stifel。

  • Annabel Samimy - Analyst

    Annabel Samimy - Analyst

  • This is Jack on for Annabel. Congrats on the quarter. So, on ZURZUVAE, I know that there the active DTC campaign running right now. Clearly, the product has been doing very well overall.

    我是 Jack,代 Annabel 發言。恭喜本季表現。關於 ZURZUVAE,我知道目前正在進行積極的 DTC(直接面向消費者)行銷活動。很明顯地,整體而言產品表現一直非常好。

  • But do you have any additional insights or color on feedback from that and how patients are responding to the DTC campaign compared to maybe a more direct physician recommendation?

    不過,您是否能就那方面的回饋提供任何額外的見解或補充說明?以及相較於較直接的醫師建議,病患對 DTC(直接面向消費者)宣傳活動的反應如何?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. Unfortunately, no, because it's really early to be able to have a good read. I mean we just started it, and you need several months of data to get a meaningful read on a response if you're getting a good response from the DTC. The only thing I can tell you is kind of anecdotal feedback from physicians, from patients who have seen it or I mean they really relate to it. The messages, the communication out of the commercial and so forth, we've received very positive feedback on that.

    是的。很遺憾,現在還不行,因為時間還太早,無法做出可靠的判讀。我的意思是,我們才剛開始,你需要幾個月的數據,才能對 DTC 是否帶來良好反應做出有意義的判讀。我唯一能分享的是一些軼聞式的回饋,來自醫師、以及看過廣告的病患——他們確實很有共鳴。對於廣告內容所傳達的訊息、商業溝通等,我們收到非常正面的回饋。

  • But in the end, it has to turn into prescriptions, of course. I mean that's really the key measure at the end of the day. And it's pretty early for us right now to say anything as far as the impact of the campaign.

    但最終當然還是要轉化為處方。我的意思是,歸根結底那才是真正關鍵的衡量指標。而就目前而言,對於活動的影響我們還太早,無法下任何結論。

  • But certainly, I mean we -- I mean the effort there is clearly to provide significant education because this is a market that needs a lot of education on the consumer side as well as on the health care provider side. And that's what we are trying to do. We've been building the market, and it takes a while to build the market, and that's something that needs to be -- continue to be invested in. But again, initial signals, which are more anecdotal seems to be positive.

    但可以肯定的是,我的意思是,我們——我們在那方面的努力顯然是要提供大量教育,因為這個市場在消費者端以及醫療照護提供者端都需要很多教育。而這正是我們正在做的事。我們一直在培育市場,而建立市場需要時間,這也需要——持續投入。但再說一次,初步訊號(較偏軼聞)看起來是正面的。

  • Annabel Samimy - Analyst

    Annabel Samimy - Analyst

  • Very helpful. And then just quickly, given your success with that collaboration, is your current M&A appetite kind of more focused on maybe something similar, like a revenue-generating partnership or more on acquisition of wholly-owned late-stage assets? Are there any shifting preferences there? Or are you still kind of agnostic to any option?

    非常有幫助。另外很快問一下,鑑於你們在那項合作上的成功,你們目前對併購(M&A)的偏好是否更聚焦在類似的模式,例如能帶來營收的合作夥伴關係,或是更偏向收購可完全持有的後期資產?這方面是否有任何偏好轉變?還是你們仍對各種選項都保持中立?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes. No, I mean our priority is revenue-generating assets that we can wholly own it and obviously build it and grow it from wherever it is at the time we buy it. And then the second priority, if it's not revenue generating, we're looking at assets that are fairly late stage.

    是的。不,我的意思是,我們的首要優先是能產生營收、且我們可以完全持有的資產,並且顯然能在我們收購時的基礎上去打造並擴大成長。第二優先順序是,如果不是能產生營收的資產,我們會尋找相當後期的資產。

  • So, these assets could potentially be launched in like between a year to three years from the time we acquired them. So that's really what we're very much focused on and fairly agnostic in the CNS space and of course, women's health as well.

    因此,這些資產在我們收購後,大約 1 到 3 年之間有機會上市。這就是我們非常聚焦的方向;在中樞神經系統(CNS)領域我們相當中立,當然在女性健康領域也是如此。

  • Annabel Samimy - Analyst

    Annabel Samimy - Analyst

  • Great. Thank you.

    很好。謝謝。

  • Operator

    Operator

  • Chi Fong, Bank of America.

    美國銀行(Bank of America)的 Chi Fong。

  • Chi Fong - Analyst

    Chi Fong - Analyst

  • I want to follow up on the bringing the second supplier online for ONAPGO. Could you give a chance to meet with the FDA to get any sort of feedback or alignment on sort of the path of getting the approval? Did any of the feedback help inform the time line guidance you provided today?

    我想追問一下 ONAPGO 啟用第二家供應商的進展。你們是否有機會與 FDA 會面,以取得任何回饋或就取得核准的路徑達成某種程度的一致?這些回饋是否有助於你們今天提供的時程指引?

  • What I'm wondering is whether there's any accelerated path like rolling submission relative to your 3Q filing guidance? And I guess on the other side of the things, on approval time line you guided to by mid-2027.

    我想了解的是,相較於你們第三季(3Q)申報的指引,是否存在任何加速路徑,例如滾動式提交(rolling submission)?另外一方面,你們指引核准時程為 2027 年年中。

  • I recall on the last earnings call, you talked about review time line could be a range somewhere in the six- to nine-month range. So, I'm curious if you have any better clarity on the review time line now if you have already met with the FDA? And I have a follow-up after that.

    我記得在上一次財報電話會議中,你們提到審查時程可能落在 6 到 9 個月的區間。所以我想知道,如果你們已經與 FDA 會面,現在對審查時程是否有更清楚的掌握?我之後還有一個追問。

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • Yes, sure. Yes, the answer is yes. We've been very much in touch with the FDA on an ongoing basis. And yes, the guidance we just gave today has been and is based on the conversations we've had with the FDA. So if we do file, which we said we're expecting to file in the third quarter, we expect the approval, again, consistent with what we said before, it could be six months to nine months.

    好的,當然。是的,答案是是。我們一直持續與 FDA 保持密切聯繫。而且是的,我們今天剛提供的指引一直都是、也確實是基於我們與 FDA 的對話。因此,如果我們提交申請——我們說過預期在第三季提交——我們預期核准時間仍與先前所說一致,可能是 6 到 9 個月。

  • So that will fall at the -- at the upper end of the time line, nine months, that means midyear 2027. And if it does take only six months for review, that obviously will be within that -- earlier than that. So that's pretty consistent. The FDA was consistent with their feedback with all the discussions we've had with them. So depending on when exactly we file, July, August, September, whatever, and then you add six months to it or it could take nine months, I mean that's really within that frame that we just gave today.

    所以若落在時程上緣、也就是 9 個月,那就會是 2027 年年中。如果審查只需要 6 個月,那顯然就會在那之前、更早一些。所以這相當一致。FDA 的回饋在我們所有討論中也都保持一致。因此取決於我們確切何時提交——7 月、8 月、9 月等等——再加上 6 個月或可能 9 個月,基本上都落在我們今天提供的那個範圍內。

  • Chi Fong - Analyst

    Chi Fong - Analyst

  • Great. And my follow-up is, obviously, the second supplier already has experience supplying the product in Europe. But given the sometimes-idiosyncratic nature of the agency handing out manufacturing issue citations and the sector more broadly, can you talk about the confidence level of timely clearance of the second supplier?

    很好。我的追問是,顯然第二家供應商已經有在歐洲供應該產品的經驗。但考量到主管機關在製造議題開立缺失(citation)時有時相當特殊、以及整個產業更廣泛的情況,你們能否談談對第二家供應商能及時取得核可的信心程度?

  • Jack Khattar - President, Chief Executive Officer, Secretary, Director

    Jack Khattar - President, Chief Executive Officer, Secretary, Director

  • I mean we have no indication that something could happen that -- that could really derail this time line from that perspective. I mean, clearly, they have -- once we submit the package, they have to, of course, review the data and so forth. And then they have to also schedule the inspection. And as far as we know, I mean, they have been doing inspections, although it is outside the US and Europe.

    我們沒有任何跡象顯示會發生什麼事情——從那個角度——會真正讓這個時程脫軌。我的意思是,當然,一旦我們提交資料包,他們就必須審查數據等等。然後他們也必須安排查廠。就我們所知,他們一直有在做查廠,雖然地點在美國與歐洲以外。

  • So, we don't see -- and we're not aware of anything that could hinder that. But that's why we continue to keep the time line fluid saying six to nine months because of that specifically, but we're not aware of anything that could tell us that this could derail this thing completely and make it not an option for us at all. So, we're pretty confident that we should be able to meet that time line and secure that second supply.

    所以,我們看不到——也沒有察覺任何可能阻礙的因素。但這也是為什麼我們持續把時程保持彈性、說是 6 到 9 個月,特別就是因為這些因素;不過我們並不知道有任何事情會讓我們判斷這件事可能完全失控,甚至讓它對我們而言根本不再是選項。因此,我們相當有信心能達成該時程並確保第二來源供應。

  • Chi Fong - Analyst

    Chi Fong - Analyst

  • Okay, great. Thanks so much for answering our question.

    好的,很好。非常感謝回答我們的問題。

  • Operator

    Operator

  • So I am showing no further questions at this time. I would now like to turn it back over to Peter Vozzo.

    我這邊顯示目前沒有其他提問。接下來我想把時間交回給 Peter Vozzo。

  • Peter Vozzo - Investor Relations

    Peter Vozzo - Investor Relations

  • Thank you for joining us on this call today. 2026 is off to a great start. We have positive momentum across our business, and we continue to generate strong cash flows beyond the strength of our growth products and through the efficiency of our operations. We look forward to continued strong growth and execution on our growth products throughout the year. Thanks again for joining us this afternoon.

    感謝各位今天參與本次電話會議。2026 年開局非常順利。我們的業務各方面都呈現正向動能,除了成長型產品的強勁表現外,也透過營運效率持續創造強勁的現金流。我們期待在今年持續推動成長型產品的強勁成長與執行落地。再次感謝各位今天下午的參與。

  • We look forward to providing you with updates throughout the year.

    我們期待在全年持續向各位提供最新進展。

  • Operator

    Operator

  • Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

    感謝各位參與今天的會議。本次議程到此結束。您現在可以掛線。