Supernus Pharmaceuticals Inc (SUPN) 2025 Q1 法說會逐字稿

Good afternoon, and welcome to Supernus Pharmaceuticals first-quarter 2025 financial results conference call. (Operator Instructions) As a reminder, this conference call is being recorded.

下午好，歡迎參加 Supernus Pharmaceuticals 2025 年第一季財務業績電話會議。（操作員指示）提醒一下，本次電話會議正在錄音。

I would now like to turn the conference over to Peter Vozzo of ICR Westwicke, Investor Relations representative for Supernus Pharmaceuticals. You may begin.

現在，我想將會議交給 ICR Westwicke 的 Peter Vozzo，他是 Supernus Pharmaceuticals 的投資者關係代表。你可以開始了。

Thank you, Lauren. Good afternoon, everyone, and thank you for joining us today Supernus Pharmaceuticals first-quarter of 2025 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.

謝謝你，勞倫。大家下午好，謝謝大家今天參加 Supernus Pharmaceuticals 2025 年第一季財務業績電話會議。今天，收盤後，該公司發布新聞稿宣布了這些結果。今天與我一起通話的還有 Supernus 的執行長 Jack Khattar 和財務長 Tim Dec。

This call is being made available via the Investor Relations section of the company's website at 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 ther's current perspective on existing trends in information.

本次電話會議可透過公司網站 ir.supernus.com 的投資者關係板塊取得。在電話會議期間，管理層可能會就未來事件和公司未來業績做出某些前瞻性陳述。這些前瞻性陳述反映了他們對現有資訊趨勢的當前觀點。

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

任何此類前瞻性陳述均不能保證未來的業績，並涉及風險和不確定性，包括公司最新 SEC 文件的風險因素部分中所述的那些註釋。實際結果可能與這些前瞻性陳述中的預測有重大差異。

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on May 5, 2025. 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 of the SEC. Supernus declined any obligation to update these form of statements except as required by applicable securities laws.

為了讓那些可能正在收聽重播的人受益，本次通話於 2025 年 5 月 5 日舉行並錄音。自那時起，該公司可能已經發布了與討論主題相關的更多公告。請參考該公司最新的新聞稿和美國證券交易委員會的最新文件。除非適用的證券法要求，否則 Supernus 拒絕承擔更新這些聲明形式的任何義務。

I will now turn the call over to Jack.

現在我將把電話轉給傑克。

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. Our first-quarter results reflect once again double digit revenue growth from our core products as well as solid growth in adjusted operating earnings.

謝謝你，彼得。大家下午好，感謝您抽空參加今天的電話會議。我們的第一季業績再次反映出我們核心產品的營收實現了兩位數成長，調整後的營業收入也實現了穩健成長。

Total revenues excluding for Trokendi XR and Oxtellar XR increased by 26% in the first quarter compared to the same quarter last year. Driving this growth was the robust performance of both Qelbree and GOCOVRI. These two products collectively accounted for 67% of total net sales, while Trokendi XR and Oxtellar XR accounted for only 9% and 7%, respectively.

第一季不包括 Trokendi XR 和 Oxtellar XR 的總收入與去年同期相比增長了 26%。推動這一成長的是 Qelbree 和 GOCOVRI 的強勁表現。這兩款產品合計佔總淨銷售額的 67%，而 Trokendi XR 和 Oxtellar XR 分別僅佔 9% 和 7%。

In the first quarter, Qelbree grew by 22% in prescriptions, as reported by IQVIA, and by 44% in net sales, the product ended the first quarter in a strong position with monthly prescriptions of March reaching an all-time high of 75,277, up 25% compared to same period last year. In addition, we continue to expand the prescriber base for Qelbree with the number of prescribers in the first quarter reaching 34,416, which is up by 23% compared to first quarter last year.

根據 IQVIA 報告，第一季 Qelbree 的處方量增加了 22%，淨銷售額成長了 44%，該產品在第一季結束時表現強勁，3 月的月處方量達到歷史最高水準 75,277 份，比去年同期成長了 25%。此外，我們繼續擴大 Qelbree 的處方者基礎，第一季的處方者數量達到 34,416 人，與去年第一季相比增加了 23%。

We are also excited about the new data from the open-label study in adults with ADHD and mood disorders. The data from all 161 adult patients will be presented at the American Psychiatric Association Annual Meeting later this month. The data show significant improvements in clinician and patient rated measures of ADHD, depression, and anxiety symptoms and the safety outcomes in the trial were consistent with the double-blind pivotal trial of Qelbree in adult ADHD.

我們也對針對患有註意力不足過動症和情緒障礙的成年人的開放標籤研究的新數據感到興奮。所有 161 名成年患者的數據將於本月稍後在美國精神醫學會年會上公佈。數據顯示，臨床醫師和患者對 ADHD、憂鬱和焦慮症狀的評定指標有顯著改善，試驗的安全結果與 Qelbree 在成人 ADHD 中的雙盲關鍵試驗一致。

Regarding GOCOVRI, for the first quarter of 2025, prescriptions increased by 12% and net sales increased by 16% compared to the same quarter last year. The Medicare Inflation Reduction Act with the reduced patient out-of-pocket costs, drove increased restrictions for GOCOVRI among Medicare patients in the first quarter compared to the same period last year.

關於GOCOVRI，2025年第一季，處方量與去年同期相比增加了12%，淨銷售額增加了16%。《醫療保險通膨削減法案》降低了病患的自付費用，與去年同期相比，第一季醫療保險病患對 GOCOVRI 的限制增加。

On average, GOCOVRI's Medicare's co-pay declined by 42% compared to the first quarter of 2024. And by March, 2025, 84% of GOCOVRI's Medicare prescriptions were costing patients less than $25. In addition, prior authorizations and medical exception approval rates remained high in the quarter.

平均而言，與 2024 年第一季相比，GOCOVRI 的醫療保險共同支付金額下降了 42%。到 2025 年 3 月，GOCOVRI 84% 的醫療保險處方費用將低於 25 美元。此外，本季的事先授權和醫療例外批准率仍然很高。

These new dynamics and the resulting growth in the first quarter suggest that any potential negative impact from increased mandatory Medicare manufacturer payments for the year could end up being offset by increased prescriptions and gross sales in Medicare.

這些新的動態和由此產生的第一季的成長表明，今年醫療保險製造商強制性支付增加所帶來的任何潛在負面影響最終都可能被醫療保險處方量和總銷售額的增加所抵消。

Early in the second quarter, we launched on ONAPGO, Supernus' next growth product. It is the first and only subcutaneous apomorphine infusion device for the treatment of moral fluctuations in adults with advanced Parkinson's disease. It was launched with a support team of experts, including the nurse education program, the access support, and utilizes our existing Parkinson's disease sales force and infrastructure.

第二季初，我們推出了 Supernus 的下一個成長產品 ONAPGO。這是第一個也是唯一一個用於治療晚期帕金森氏症成年人情緒波動的皮下阿撲嗎啡輸注裝置。它是由一個專家支援團隊發起的，包括護理教育計劃、訪問支持，並利用我們現有的帕金森氏症銷售團隊和基礎設施。

Initial response from physicians has been encouraging based on patient enrollment forms submitted early in the launch. And only a few weeks into the launch, more than 75% of the sales territories that generated one or more patient enrollment form with more than 100 prescribers submitted such forms.

根據推出初期提交的病患登記表，醫師的初步反應令人鼓舞。僅在產品推出幾週後，就有超過 75% 的銷售區域提交了一張或多張患者登記表，並且有超過 100 名處方人員提交了此類表格。

Switching now to our legacy products for the first quarter of 2025, combined net sales of Trokendi XR and Oxtellar XR were down 46%. For the remainder of 2025, we expect further erosion on both product sales and maintain our 2025 guidance of $65 million to $75 million in combined net sales.

現在轉向我們的傳統產品，2025 年第一季度，Trokendi XR 和 Oxtellar XR 的總淨銷售額下降了 46%。對於 2025 年剩餘時間，我們預計兩種產品的銷售額將進一步下滑，並維持 2025 年合併淨銷售額 6,500 萬至 7,500 萬美元的預期。

Moving on to our CNS pipeline of novel product candidates, we plan to initiate a follow-on Phase 2b multi-center randomized double-blind placebo-controlled trial with SPN-820 and approximately 200 adults with major depressive disorders. This study will examine the safety and tolerability of SPN-820 at a dose of 2,400 milligram given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms.

繼續討論我們的中樞神經系統 (CNS) 新產品候選管線，我們計劃啟動後續的 2b 期多中心隨機雙盲安慰劑對照試驗，試驗對象為 SPN-820 和大約 200 名患有重度憂鬱症的成年人。這項研究將檢視每週兩次間歇性服用 2,400 毫克 SPN-820 作為當前基線抗憂鬱療法的輔助治療的安全性和耐受性，並評估憂鬱症狀的快速改善。

As we mentioned on our last call, we completed a pharmacogenetic study of two oral formulations of SPN-443 in healthy adults. Both formulations of SPN-443 shows adequate bioavailability and work well tolerated. SPN-443 is our new stimulus-like product candidate for ADHD and other CNS disorders. The company expects to disclose a need indication for the product by the end of 2025.

正如我們在上次電話會議上提到的，我們完成了對健康成年人的兩種口服 SPN-443 製劑的藥物基因組學研究。SPN-443 的兩種配方均顯示出足夠的生物利用度並且耐受性良好。SPN-443 是我們針對 ADHD 和其他中樞神經系統疾病的新型刺激類候選產品。該公司預計將在 2025 年底前揭露該產品的需求指示。

Regarding corporate development, it continues to be a top priority for us looking for strategic opportunities to further strengthen our future growth with revenue generating products or late stage pipeline product candidates. And finally, given the current environment for tariffs, it is difficult to predict what impact, if any, they could potentially have on our business.

關於企業發展，尋找策略機會以透過創收產品或後期產品候選進一步加強我們未來的成長仍然是我們的首要任務。最後，鑑於當前的關稅環境，很難預測它們會對我們的業務產生什麼影響（如果有的話）。

We don't expect tariffs on finished products to impact Qelbree, Trokendi XR or GOCOVRI, ONAPGO or APOKYN, as they are either manufactured in the US or are under arrangements that shield us from impact of On the other hand, MYOBLOC, XADAGO or Oxtellar XR finished products are manufactured in Europe or in Canada and therefore could become subject to import tariffs.

我們預計成品關稅不會影響 Qelbree、Trokendi XR 或 GOCOVRI、ONAPGO 或 APOKYN，因為它們要么在美國製造，要么根據協議保護我們免受影響。另一方面，MYOBLOC、XADAGO 或 Oxtellar XR 成品在歐洲或加拿大製造，因此可能會受到進口關稅的影響。

All our products, raw materials are imported from various countries outside the US, therefore, any potential impact from tariffs will highly depend on numerous factors, including but not limited to current inventory levels of various raw materials, timing of any new orders that may be subject to the tariffs, the country of origin for the various materials, and the applicable percentage tariffs.

我們的所有產品和原材料均從美國以外的各個國家進口，因此，關稅的任何潛在影響都將高度取決於多種因素，包括但不限於各種原材料的當前庫存水平、可能受關稅影響的任何新訂單的時間、各種材料的原產國以及適用的關稅百分比。

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

現在，我將把發言權交給提姆。

Thank you, Jack. Good afternoon, everyone. As I review our first quarter 2025 results, please refer to today's press release and 10-K that was filed earlier today.

謝謝你，傑克。大家下午好。當我回顧我們 2025 年第一季的業績時，請參閱今天的新聞稿和今天早些時候提交的 10-K。

Total revenue for the first quarter of 2025 was $149.8 million compared to $143.6 million in the first quarter of 2024. Total revenue in the first quarter of 2025 was comprised of net product sales of $142 million and royalty revenues of $7.8 million. This $3.5 million increase in net product sales was primarily due to increase in net product sales of our core products, Qelbree and GOCOVRI.

2025 年第一季總營收為 1.498 億美元，而 2024 年第一季總營收為 1.436 億美元。2025 年第一季的總收入包括 1.42 億美元的淨產品銷售額和 780 萬美元的特許權使用費收入。淨產品銷售額增加 350 萬美元主要是因為我們的核心產品 Qelbree 和 GOCOVRI 的淨產品銷售額增加。

Excluding net product sales of Trokendi XR and Oxtellar XR in both periods, total revenues for the first quarter of 2025 increased 26% compared to the first quarter of 2024. For the first quarter of 2025, combined R&D and SG&A expenses were $116.9 million as compared to $111.4 million for the prior year quarter. The increase was primarily due to higher R&D spend associated with our ongoing clinical programs as we continue to progress our pipeline.

不包括兩個時期 Trokendi XR 和 Oxtellar XR 的淨產品銷售額，2025 年第一季的總收入與 2024 年第一季相比成長了 26%。2025 年第一季度，研發銷售、一般及行政費用總計為 1.169 億美元，去年同期為 1.114 億美元。這一增長主要是由於與我們正在進行的臨床項目相關的研發支出隨著我們繼續推進而增加。

Operating loss on a GAAP basis for the first quarter of 2025 was $10.3 million as compared to an operating loss of $3.2 million for the prior year period. This increase was primarily due to higher contingent consideration loss related to the achievement of ONAPGO-related milestones.

2025 年第一季以 GAAP 計算的營業虧損為 1,030 萬美元，而去年同期的營業虧損為 320 萬美元。這一增長主要是由於與實現 ONAPGO 相關里程碑有關的或有對價損失增加所致。

GAAP net loss was $11.8 million for the first quarter of 2025, or loss per diluted share of $0.21, compared to GAAP net earnings of $124,000 or earnings per diluted share of zero cents in the prior year quarter. On a non-debt basis, which excludes amortization and tangibles, share-based compensation, contingent consideration, and depreciation, adjusted operating earnings for the first quarter of 2025 was $25.9 million compared to $22.3 million in the first quarter of 2024.

2025 年第一季 GAAP 淨虧損為 1,180 萬美元，即每股攤薄虧損 0.21 美元，去年同期 GAAP 淨收益為 124,000 美元，即每股攤薄收益為零美分。以非債務基礎計算，不包括攤銷和有形資產、股權激勵、或有對價和折舊，2025 年第一季的調整後營業收入為 2,590 萬美元，而 2024 年第一季為 2,230 萬美元。

As of March 31, 2025, the company had approximately $463.6 million in cash, cash equivalents, and marketable securities, compared to $453.6 million as of December 31, 2024. This increase was primarily due to cash generated from operations offset by $25 million repayment of the ONAPGO-related milestones in the first quarter of 2025. The company continues to have a strong balance sheet with significant financial flexibility for potential M&A or other value creating opportunities.

截至 2025 年 3 月 31 日，該公司擁有約 4.636 億美元的現金、現金等價物和有價證券，而截至 2024 年 12 月 31 日為 4.536 億美元。這一成長主要是由於經營活動產生的現金被 2025 年第一季償還 ONAPGO 相關里程碑的 2,500 萬美元所抵銷。該公司繼續擁有強勁的資產負債表，並為潛在的併購或其他價值創造機會提供巨大的財務靈活性。

Now turning to guidance. For the full year 2025, the company reiterates its financial guidance for total revenue, combined R&D and SG&A expenses and non-GAAP operating earnings. As such, we expect total revenues to range from $600 million to $630 million comprised of net product sales and royalty revenues. For the full year 2025, we expect combined R&D and SG&A expenses to range from $435 million to $460 million.

現在轉向指導。對於 2025 年全年，該公司重申其對總收入、綜合研發和銷售、一般及行政費用以及非公認會計準則營業收入的財務指導。因此，我們預計總收入將在 6 億美元至 6.3 億美元之間，包括淨產品銷售額和特許權使用費收入。我們預計 2025 年全年研發與銷售、一般及行政費用總額將介於 4.35 億至 4.6 億美元之間。

Overall, we expect full-year 2025 GAAP operating earnings loss in the range of $15 million GAAP operating loss to $10 million GAAP operating earnings, and non-GAAP operating earnings to range from $105 million to $130 million. Please refer to the earnings pressure release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP.

總體而言，我們預計 2025 年全年 GAAP 營業利潤損失將在 1,500 萬美元至 1,000 萬美元之間，非 GAAP 營業利潤將在 1.05 億美元至 1.3 億美元之間。請參閱本次電話會議之前發布的盈利壓力報告，其中列出了 GAAP 和非 GAAP 之間各種調整項目的範圍。

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

說完這些，我現在將電話轉回給接線生進行問答。操作員？

(Operator Instructions)

（操作員指示）

Andrew Tsai, Jefferies.

安德魯·蔡（Andrew Tsai），傑富瑞（Jefferies）。

This is John for Andrew. Thanks for taking the question. Could you just please remind us the key growth drivers for Qelbree in 2025? And is it fair that 2025 will be more about volume and price? Or could sales still be driven by volume and price?

我是安德魯的約翰。感謝您回答這個問題。您能否提醒我們 Qelbree 在 2025 年的主要成長動力是什麼？2025 年將更加重視數量和價格，這公平嗎？或者銷售仍受銷售量和價格驅動？

And then could you just provide a little more color on your decision to move forward with 820 in MDD? Like, what kind of placebo-adjusted efficacy delta do think you could ultimately show? And then when can we expect data? Thanks.

那麼，您能否更詳細地說明您決定在 MDD 中推進 820 的決定？例如，您認為最終可以展示什麼樣的安慰劑調整功效增量？那我們什麼時候可以獲得數據？謝謝。

Yeah. Regarding, Qelbree, the growth is going to be combined. I mean volume and a little bit of price. We took price increase a very small pricing January, but the majority of the growth is going to be based on volume and growth in prescriptions. As we showed, I mean we had a really good first quarter or go typically first quarter. You know, you might see some -- a little bit slow down in growth and so forth, or you can see flash and trend in the first quarter.

是的。至於 Qelbree，成長將會合併。我指的是數量和一點點價格。我們在一月份進行了小幅價格上調，但大部分增長將基於數量和處方的增長。正如我們所展示的，我的意思是我們第一季的表現非常好，或者說是典型的第一季表現。你知道，你可能會看到一些——增長略有放緩等等，或者你可以在第一季看到閃光和趨勢。

We're pretty happy with where we stand with Qelbree. As I mentioned, in my remarks, March came in really high, all the time, high of 75,000 plus as far as descriptions are concerned, which are 25% growth versus last year. So we're pretty optimistic on where the band is and the position it's in in the first quarter, and certainly look forward to more growth in the subsequent quarters.

我們對 Qelbree 的現狀非常滿意。正如我在發言中提到的，3 月份的新增病例數量確實很高，就描述而言，已經超過 75,000 例，與去年相比增長了 25%。因此，我們對樂團的現狀和第一季的地位非常樂觀，當然期待接下來的幾季能有更大的成長。

As far as SPN-820, regarding the expectation as far as placebo-adjusted improvement in MADRS and so forth. If you remember in the open label, and it's very hard of course to make these comparisons because it was an open label study, we had very significant reduction in MADRS and yet in the Phase 2b subsequently, we had placebo effect in the 12 point -- 10 point to 12 point reduction in MADRS.

就 SPN-820 而言，關於安慰劑調整後的 MADRS 改善的預期等等。如果您還記得開放標籤研究，當然很難進行這些比較，因為這是一項開放標籤研究，我們的 MADRS 有非常顯著的減少，但在隨後的 2b 階段，我們在 MADRS 中出現了 12 分（10 分到 12 分）的安慰劑效應。

So if you account for something of that nature and we can do a little bit more than the placebo by 5 to 8 points, which is typically what is considered to be clinically and medically relevant and significant, that will be something that certainly we will be shooting for. So anything between around the 5- to 8-point reduction in MADRS placebo-adjusted will be a clinically significant reduction.

因此，如果考慮到這種性質，我們可以比安慰劑多做 5 到 8 點，這通常被認為具有臨床和醫學相關性和重要性，那肯定會是我們努力的目標。因此，經安慰劑調整後的 MADRS 評分降低 5 到 8 個百分點左右，將具有臨床意義。

And that certainly, we hope to get even more than that given the initial results that we had way back in the open label. And again, the reason we decided to do the follow on study on 820 is because of the different dosing regimen. So we believe the mTORC1 mechanism is as such that this is a target that you don't have to hit very frequently every single day. But if you do it intermittently, as we did back in the open label, we have a much better and higher chance of showing the impact of the drug.

當然，考慮到我們在開放標籤方面取得的初步成果，我們希望能取得更多的成果。再次強調，我們決定對 820 進行後續研究的原因是由於不同的給藥方案。因此，我們認為 mTORC1 機制是這樣的，這是一個你不必每天頻繁達到的目標。但如果你間歇性地進行，就像我們在開放標籤中所做的那樣，我們就有更好、更高的機會展示藥物的影響。

Thanks so much. And then when could we possibly expect data read out from the study?

非常感謝。那我們什麼時候可以讀取研究數據呢？

Yeah, at this point we're looking -- and we're not promising this yet because there is a lot of work to be done in preparation for the new study. But at best case, we'll probably start the study before year end this year and therefore we need a good 1.5 years to finish the study and get data.

是的，目前我們正在研究——但我們還沒有做出承諾，因為在準備新的研究方面還有很多工作要做。但在最好的情況下，我們可能會在今年年底之前開始這項研究，因此我們需要整整一年半的時間來完成這項研究並獲得數據。

So depending on recruitment of course and looking at 200 patients will be randomized, so depending on how quickly we can do that. Now, it is MDD, so it should go a little bit faster than the TRD study. So that will remain to be seen. We'll certainly update folks as time goes on.

因此，當然取決於招募情況，並且 200 名患者將被隨機分配，所以取決於我們能多快做到這一點。現在，它是 MDD，因此它應該比 TRD 研究快一點。因此這還有待觀察。隨著時間的推移，我們一定會向大家更新最新情況。

Great, thanks so much.

太好了，非常感謝。

Stacy Ku, TD Cowen.

史黛西·庫（Stacy Ku），考恩公司（Cowen）TD。

Hey, good afternoon. Thanks for taking my questions. So the first is on Qelbree. Just how much of the normal seasonality or Q1 dynamics impact Qelbree net pricing this quarter? And how should we think about the jump to Q2, the remainder of the year in terms of gross to nets? And then maybe could you comment on the level of comfort you might have on Qelbree consensus around $290 million for the year? That's kind of the first question.

嘿，下午好。感謝您回答我的問題。第一個是在 Qelbree。正常的季節性或第一季的動態對 Qelbree 本季的淨定價有多大影響？那麼，從總額與淨額的角度來看，我們該如何看待第二季以及今年剩餘時間的成長？然後，您能否評論一下您對 Qelbree 全年約 2.9 億美元的預期程度？這是第一個問題。

And then the second question is on ONAPGO. As we think about the infrastructure required, maybe talk about the plumbing to make sure all start forms can be transformed into patient prescriptions, getting patients on drug. What are your thoughts on the timing to go from a start form to getting on ONAPGO to the patient? So thanks so much.

第二個問題是關於 ONAPGO 的。當我們考慮所需的基礎設施時，也許會談論管道，以確保所有開始表格都可以轉換為患者處方，讓患者服用藥物。您對從開始表格到患者開始使用 ONAPGO 的時間有何看法？非常感謝。

Yeah. Regarding Qelbree, Q1 as we always discuss typically tends to have pressure on the gross to net, clearly and they the price for prescription. So in the first quarter, gross the net went up to somewhere in the early 50s, you know, 51%, 52% somewhere in that region, which is very expected.

是的。關於 Qelbree，正如我們經常討論的那樣，Q1 通常會對總收入和淨收入產生壓力，顯然，這也是處方藥的價格。因此，在第一季度，毛利率和淨利率上升到了 50% 左右，也就是 51% 到 52% 左右，這是非常符合預期的。

And then typically, if we do follow the typical trends, it should see some improvement in second quarter and third quarter unless there is a onetime issue that pops up that is unforeseen and that could cause quarter to quarter fluctuations.

通常情況下，如果我們遵循典型的趨勢，第二季和第三季應該會看到一些改善，除非出現無法預見的一次性問題，這可能會導致季度間的波動。

As far as the consensus of the $290 million annual, I mean, we feel comfortable with that number, although again, we don't give official guidance for product. But certainly the product is doing very well and should do very well for the rest of the year.

至於每年 2.9 億美元的共識，我的意思是，我們對這個數字感到滿意，儘管我們沒有為產品提供官方指導。但可以肯定的是，該產品的銷量非常好，並且在今年剩餘時間內應該也會表現良好。

Regarding ONAPGO and the infrastructure, the infrastructure is very well-established clearly because of the few years now we've been in the space in Parkinson's with APOKYN and end GOCOVRI. So the whole infrastructure from salesforce to the hub services, nurse, educators, reimbursement, health, all that has been already established and has been improved actually over the last several years in preparation as well for ONAPGO.

關於 ONAPGO 和基礎設施，顯然基礎設施已經非常完善，因為幾年來我們一直在帕金森氏症領域開展 APOKYN 和 GOCOVRI 工作。因此，從銷售人員到中心服務、護士、教育工作者、報銷、健康的整個基礎設施都已經建立，並且在過去幾年中實際上已經得到改進，為 ONAPGO 做好了準備。

So it is a little bit hard right now because we just launched the product and we just started getting all the patient enrollment forms to give you a good idea as to how long the cycle would be from the patient enrollment form until the patient actually gets the product. But from our experience, from GOCOVRI and APOKYN and so forth, we are well within the industry average, if not a little bit better. And the same thing goes with the prior authorizations or getting the actual reimbursements.

所以現在有點困難，因為我們剛剛推出產品，我們剛開始獲取所有患者登記表，以便讓您很好地了解從患者登記表到患者實際獲得產品的周期需要多長時間。但從我們的經驗來看，從 GOCOVRI 和 APOKYN 等來看，我們完全處於行業平均水平，甚至略勝一籌。事先授權或獲得實際報銷也是如此。

So really how many out of the patient enrollment forms end up actually translating into actual product that gets in the hands of the patients. We typically run at a little bit better than industry average with our rates. It's not the 40% to 50%, it's in that range. So we feel very optimistic about the process that we have and really making sure we can process these patient enrollment forms and get the product to the patient as soon as possible.

那麼，到底有多少病患登記表最終真正轉化為到達病患手中的實際產品呢？我們的營運費率通常比行業平均略高一些。這不是 40% 到 50%，而是在這個範圍內。因此，我們對現有的流程感到非常樂觀，並確保我們能夠處理這些患者登記表並儘快將產品送到患者手中。

Sure. Thank you so much.

當然。太感謝了。

Annabel Samimy, Stifel.

安娜貝爾·薩米 (Annabel Samimy)，Stifel。

Hi, this is Jack on for Annabel. Thanks for taking our questions. So could you provide maybe some more details around reimbursement discussions and how we should think about the trajectory of launch for ONAPGO? Are there any points of differentiation that physicians are immediately looking towards compared to something like AbbVie's pump?

大家好，我是傑克，為您介紹安娜貝爾。感謝您回答我們的問題。那麼您能否提供一些有關報銷討論的更多細節，以及我們應該如何考慮 ONAPGO 的發布軌跡？與 AbbVie 的幫浦等產品相比，醫生們是否立即關注哪些差異點？

Yeah. Regarding the endorsement, as I mentioned earlier, we expect very good level and percentage of these enrollment forms to end up going through all the way and fulfilled -- actually fulfilled so that the patient ends up getting the product itself. We have complete support for that throughout the process right from the beginning. If they can enrollment forms, you know, gets written up.

是的。關於認可，正如我之前提到的，我們預計這些登記表格中有很大一部分能夠順利通過並得到滿足——實際上已經得到滿足，以便患者最終能夠得到產品本身。從一開始，我們就在整個過程中提供全力支持。如果他們可以的話，入學表格就會被寫下來。

It's really a very high level of service in taking that form and we walking it through with the hub services all the way to make sure that the reimbursement adjudication for all that insurance and everything works out as smooth as possible. And we had -- actually before we really launched the product so to speak, we had some early ones that we ran through the process to test the process and make sure it is smooth so that when the product first became available, and some of these forms started flowing through, we had the process worked out.

採用這種形式確實是一種非常高水準的服務，我們會全程與中心服務部門合作，以確保所有保險的報銷裁決和一切事宜盡可能順利地進行。事實上，在我們真正推出該產品之前，我們已經進行了一些早期的流程測試，以確保其順利進行，這樣當產品首次上市時，當其中一些表格開始流過時，我們就已經制定好了流程。

So we were pretty confident about that. As far as the product differentiation, I mean, the product clearly, first of all, it's a very different molecule than anything that is out there, except for, of course, APOKYN. So apomorphine is a very strong potent molecule that works very well. It's a good dopamine agonist, probably one of the best out there and it works really well.

所以我們對此非常有信心。就產品差異化而言，我的意思是，該產品顯然首先是與現有的任何產品都非常不同的分子，當然，APOKYN 除外。因此，阿撲嗎啡是一種非常強效的分子，效果非常好。它是一種很好的多巴胺激動劑，可能是目前最好的多巴胺激動劑之一，而且效果非常好。

And we know that well from the efficacy and the data that came out of the study on ONAPGO as well as APOKYN in general, I mean, as a molecule. So it's the only pump clearly that provides that option to patients, continuous infusion of apomorphine.

我們從對 ONAPGO 以及 APOKYN 的整體研究（我的意思是作為分子）的功效和數據中清楚地知道這一點。因此，它顯然是唯一能夠為患者提供持續輸注阿撲嗎啡的選擇的幫浦。

And a lot of patients out there, you don't have too many choices. And if you've been on levodopa/carbidopa for so many years, do you really want to have another product that gives you also levodopa/carbidopa or do you want to switch to something else that could be more beneficial? So this is really a decision that clearly the movement disorder specialist will make as appropriate for each patient they have.

對很多患者來說，他們沒有太多的選擇。如果您已經服用左旋多巴/卡比多巴這麼多年，您真的想要另一種也能提供左旋多巴/卡比多巴的產品嗎？還是您想換用其他可能更有益的產品？因此，這實際上是運動障礙專家根據每個患者的情況做出的決定。

So there is a clear differentiation for the product also from safety, tolerability. You can take a look at the label of our product versus the label of the other products out there. It will show some clear differentiation. As far as efficacy, they're fairly comparable, the two products, not as much of a differentiation. So that's the general framework without having obviously head-to-head trials, it is very difficult to make these comparisons.

因此，產品的安全性和耐受性也有明顯的差異。您可以查看我們的產品標籤與其他產品的標籤。它將顯示一些明顯的差異。就功效而言，這兩種產品相當具有可比性，差異不大。所以這是總體框架，如果沒有明顯的面對面試驗，就很難進行這些比較。

Got it. And then if I could just ask one more. For SPN-820, was there anything you were able to gather from the Phase 2 in treatment resistant depression that could either maybe revive that program and or give you some extra comfort on the Phase 2b and major depressive disorder? Do you see that indication as likely dropped at this point or have you not finished going through that data?

知道了。然後我是否可以再問一個問題。對於 SPN-820，您是否能夠從難治性憂鬱症的 2 期研究中收集到任何信息，這些信息或許可以恢復該項目，或者在 2b 期和重度抑鬱症方面給您帶來一些額外的安慰？您是否認為該指標此時可能會下降，或者您還沒有完成對該數據的分析？

Yeah. We didn't see from all the data and everything that we've been doing since we announced the results, we didn't see anything that points to the fact that it's an indication driven difference that we saw between the two studies. The key difference is the dosing regimen. So what I'm saying is initially we're going to go after MDD with the follow on study, that doesn't mean we're giving up on TRD.

是的。自從我們公佈結果以來，從所有數據和我們所做的一切來看，我們沒有看到任何跡象表明我們在兩項研究中看到的差異是由指示驅動的。主要的差異在於給藥方案。所以我想說的是，我們最初會繼續研究 MDD，但這並不意味著我們放棄 TRD。

So we think the product would work in both, but MDD could be quicker as far as enrollment or what have you. And that's why we chose to go with MDD at this point as a follow on study. So we're not dealing up on TRD because we think that the product mechanistically, if it works in MDD, it should work in TRD. And the only reason it didn't work in the Phase 2b most likely is because of the dosing regimen.

因此我們認為該產品可以在兩種環境下運行，但就註冊或其他方面而言，MDD 可能會更快。這就是我們選擇採用 MDD 作為後續研究的原因。因此，我們不會處理 TRD，因為我們認為，從機制上講，如果產品在 MDD 中可以運行，那麼它也應該在 TRD 中可以運行。它在第 2b 階段不起作用的唯一原因很可能是因為給藥方案。

Understood, thanks.

明白了，謝謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆、派珀·桑德勒。

Thanks. So just a couple for me. First, on ONAPGO, I know these are early days, but what are you hearing in the field regarding competitive dynamics versus the Vyalev, the AbbVie product? And specifically, are you getting any pushback regarding the use of apomorphine in general when there is another subcu pump available that delivers levodopa and carbidopa? So that's number one.

謝謝。對我來說只有幾個。首先，關於 ONAPGO，我知道現在還處於早期階段，但您聽到哪些與 AbbVie 產品 Vyalev 競爭的動態？具體來說，當有另一種可以輸送左旋多巴和卡比多巴的皮下泵可用時，您是否對阿撲嗎啡的使用有任何阻力？這是第一點。

Just talk to the competitive dynamics and what you are seeing and expect to see. And then just turning to the pipeline on 443, I know you're going to disclose a lead indication by the end of this year. But since it is a stimulant, is it fair to say that sleep-wake could be on the table here, either narcolepsy or idiopathic hypersomnia or both? And how are you just thinking about that in terms of its fit for what you plan to do with that asset? Thank you.

只需談論競爭動態以及您所看到的和期望看到的。然後談到 443 號管道，我知道您將在今年年底前披露領先跡象。但既然它是一種興奮劑，那麼是否可以公平地說，睡眠-覺醒可能出現在這個討論範圍內，無論是發作性睡病還是特發性嗜睡症，還是兩者兼而有之？您如何看待它與您計劃利用該資產的方式相符？謝謝。

Yeah. I think regarding ONAPGO, all I can say is initially and this was again very early. As I mentioned in our prepared remarks we're very encouraged actually with the reaction to the product. The receptivity, the response from physicians and the level of activity that we've seen behind the product. So we also started to get some initial feedback regarding our Circle of Care, which is our support system that we give our patients positive feedback.

是的。我認為關於 ONAPGO，我只能說這只是初步情況，而且這還是很早的時期。正如我在準備好的演講中提到的那樣，我們對該產品的反應感到非常鼓舞。我們看到該產品的接受度、醫生的反應以及活動量。因此，我們也開始收到一些關於我們的護理圈的初步回饋，這是我們為患者提供正面回饋的支持系統。

Again, clearly we've had this program for a number of years right now. We've kind of perfected it and improved over the year. And we've had it for GOCOVRI and APOKYN, and now we're applying it to ONAPGO. So we emphasize, of course, the level of service that we're giving our patients and our physicians.

再次強調，很明顯我們已經實施這個計畫好幾年了。經過一年的努力，我們已經對它進行了完善和改進。我們已經將它應用於 GOCOVRI 和 APOKYN，現在我們將它應用於 ONAPGO。因此，我們當然強調我們為患者和醫生提供的服務水準。

And we see that as a competitive advantage actually in the marketplace. And so far, all indications are very positive and very encouraging. I focus everybody because it's very early in the launch. Of course, it's only a few weeks. But certainly, it's to a very strong start, better than our expectations initially, and hopefully will continue to be that way.

我們認為這其實是市場上的競爭優勢。到目前為止，所有跡像都非常積極、令人鼓舞。我讓每個人都集中註意力，因為發布才剛開始。當然，只有幾週的時間。但可以肯定的是，這是一個非常強勁的開端，比我們最初的預期要好，並且希望能夠繼續保持這種狀態。

And as far as, again, apomorphine versus levodopa/carbidopa, that is something that a physician will have to make that decision. I mean, if you have a patient, and these are patients that are advanced, progress, and that's really the patient type that you're looking at for these infusion devices. If this is a patient who's been taking levodopa/carbidopa for 5 years, 10 years, 15 years, whatever the case might be. Do you really want to put them back on libidopa/carbidopa?

至於阿撲嗎啡與左旋多巴/卡比多巴的選擇，這需要醫生來做決定。我的意思是，如果你有一個病人，這些病人是晚期的、有進展的，這就是你正在尋找的輸液設備的患者類型。如果這是一位服用左旋多巴/卡比多巴 5 年、10 年、15 年的患者，無論情況如何。你真的想讓他們重新服用利比多巴/卡比多巴嗎？

And with the other infusion device, because it is levodopa/carbidopa, you can't use it as an add-on to the oral levodopa/carbidopa. Basically, you have to replace the oral completely. But with our pump, because it is apomorphine, you could still continue to keep the patient on the oral libidopa/carbidopa, while at the same time using ONAPGO infusion device gives you apomorphines. So that's another clear differentiation between the two products. And being an add-on could prove to be a potential advantage. We will see in the marketplace.

而對於其他輸注裝置，由於它是左旋多巴/卡比多巴，因此不能將其用作口服左旋多巴/卡比多巴的附加劑。基本上，你必須徹底更換口腔。但使用我們的泵，因為它是阿撲嗎啡，您仍然可以繼續讓患者口服利比多巴/卡比多巴，同時使用 ONAPGO 輸注裝置為您提供阿撲嗎啡。這是兩種產品之間的另一個明顯區別。而作為附加元件可能會被證明是一種潛在的優勢。我們將在市場上看到。

Regarding the pipeline and 443, we are looking at 443 as we have presented earlier a long time before as a potential stimulant for ADHD with potential Schedule 4 instead of C2 scheduling. So that would be a huge advantage in the marketplace. But we're also looking at it for other indications, and that's why we haven't made the final, final selection of what indication will be the lead indication.

關於管道和 443，我們正在研究 443，正如我們很久以前提出的那樣，它是一種潛在的 ADHD 興奮劑，具有潛在的 Schedule 4 而不是 C2 安排。所以這在市場上將是一個巨大的優勢。但我們也在尋找其他適應症，這就是為什麼我們還沒有最終選擇哪種適應症作為主要適應症。

So we could choose the lead indication and potentially other indications as well as a follow-on to the lead indication. So we're still finalizing now some of the work we're doing, some animal models and so forth, and would make that decision before the end. But it's a pretty exciting asset and it remains to be seen as to where we take it initially and then follow on with other indications potentially.

因此，我們可以選擇先導適應症和潛在的其他適應症以及先導適應症的後續治療。因此，我們現在仍在完成我們正在進行的一些工作、一些動物模型等等，並將在結束之前做出決定。但它是一種非常令人興奮的資產，我們最初會把它帶到哪裡，然後再根據其他跡象進行後續觀察，這還有待觀察。

Okay. Thank you.

好的。謝謝。

(Operator Instructions)

（操作員指示）

Kristen Kluska, Cantor Fitzgerald.

克里斯汀·克魯斯卡，坎托·菲茨杰拉德。

Hi, this is Ian on the line for Kristin. Thank you for taking our questions. On Qelbree, do you have a sense of the proportion of naive patients that are getting on an ADHD medication for the first time and they're deciding on taking Qelbree? And then you previously mentioned the combination use within the adult population being around 35% to 40% of the prescription. Has this changed?

你好，我是伊恩，找克里斯汀。感謝您回答我們的問題。關於 Qelbree，您是否了解首次服用 ADHD 藥物並決定服用 Qelbree 的初始患者的比例？您之前提到，成年人群中的合併用藥佔處方藥量的 35% 至 40% 左右。這有改變嗎？

Yeah. Regarding Qelbree, the split of the source of business or the source of patients, so to speak, it's around 32%, 33% it bounces around that are completely naive first line treatment on Qelbree. And then the remaining 67%, 68% are basically switches or most of them are switches from existing medications.

是的。關於 Qelbree，業務來源或患者來源的劃分，可以說，大約是 32%、33% 左右，這些是 Qelbree 上完全幼稚的一線治療。剩下的 67%、68% 基本上是轉換藥物，或者大多數是從現有藥物轉換而來。

The bulk of that switch typically comes from the stimulant side, products like Vyvanse, Adderall, or generics in general. And then the 35% of the switches typically is coming from the other non-stimulants like Strattera, Intuniv, and so forth.

這種轉變主要源自於興奮劑方面，例如 Vyvanse、Adderall 等產品或一般的仿製藥。然後 35% 的轉換通常來自其他非興奮劑，如 Strattera、Intuniv 等。

As far as the combination use, I think it's still around between the 35% and 40% in adult being in combination. It will be interesting to see as the data gets more disseminated and people learn more about some of the data and the label of the product and so forth, whether that will change over time. Potentially it could, especially with lot of the adults who have lot of comorbidities. But that remains to be seen. But at this point, it's still around that range, yeah.

就合併使用而言，我認為成人聯合使用的比例仍在 35% 至 40% 之間。有趣的是，隨著數據傳播得越來越廣，人們對某些數據和產品標籤等的了解越來越多，這些數據是否會隨著時間的推移而改變。有可能，尤其是對於許多患有合併症的成年人來說。但這還有待觀察。但目前，它仍然在這個範圍內，是的。

I got it. Thank you.

我得到了它。謝謝。

I'm showing no further questions at this time. I would now like to turn it back to Jack Khattar for closing remarks.

我目前沒有其他問題。現在我想請傑克·卡特爾致最後總結。

Thank you for joining us to learn about our operating performance in the first quarter of 2025. The company has executed well through the loss of exclusivity on two of its legacy products. Excluding these legacy products, we continue to deliver robust double-digit growth and revenues.

感謝您加入我們，了解我們2025年第一季的經營業績。儘管失去了兩款傳統產品的獨家經營權，但該公司仍然表現良好。除這些傳統產品外，我們繼續實現強勁的兩位數成長和收入。

Also, we continue to generate strong cash flows behind the strength of our portfolio, particularly our core products and through the efficiency of our operations. We believe we are well positioned for continued growth beyond the current transition and our focus on several key areas.

此外，憑藉我們強大的產品組合（尤其是核心產品）和高效的運營，我們將繼續創造強勁的現金流。我們相信，在當前轉型期和重點關注的幾個關鍵領域之後，我們已準備好繼續實現成長。

First, driving growth and generating strong cash flow from our core products, allowing us to continue our investments in our pipeline; second, the launch of ONAPGO and strengthening our leadership position in Parkinson's; third, advancing our innovative R&D portfolio of differentiated first-in-class molecules; and finally, continuing our emphasis on corporate development as a top priority to augment our role through external opportunities.

首先，推動成長並從核心產品中產生強勁的現金流，使我們能夠繼續投資於我們的產品線；其次，推出 ONAPGO 並加強我們在帕金森氏症領域的領導地位；第三，推進我們差異化一流分子的創新研發組合；最後，繼續將企業發展作為首要任務，透過外部機會增強我們的作用。

Thanks again for joining us this afternoon. We look forward to updating you on our next call.

再次感謝您今天下午加入我們。我們期待在下次通話中向您通報最新情況。

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

感謝大家參加今天的會議。該計劃確實就此結束。您現在可以斷開連線。