Supernus Pharmaceuticals Inc (SUPN) 2024 Q2 法說會逐字稿

Good afternoon and welcome to the Supernus Pharmaceuticals' second-quarter 2024 financial results conference call. (Operator Instructions)

下午好，歡迎參加 Supernus Pharmaceuticals 2024 年第二季財務業績電話會議。（操作員說明）

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

謹此提醒，本次電話會議正在錄音中。我現在想將會議轉交給 ICR Westwicke 的 Peter Vozzo，他是 Supernus Pharmaceuticals 的投資者關係代表。你現在就可以開始了。

Thank you, Corinne. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' second-quarter 2024 financial results conference call. Today, after the close of the market, the company issued a press release announcing these results.

謝謝你，科琳娜。大家下午好，感謝您今天參加 Supernus Pharmaceuticals 2024 年第二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。

On the call with me today are Supernus' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec. Today's call is being made available via the Investor Relations section of the company's website at ir.supernus.com.

今天與我通話的有 Supernus 執行長 Jack Khattar 和財務長 Tim Dec。

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.

在本次電話會議期間，管理階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 Supernus 目前對現有趨勢和資訊的看法。

Any such forward-looking statements are not guaranteed 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不能保證未來業績，並涉及風險和不確定性，包括該公司最新向 SEC 備案的風險因素部分中指出的風險和不確定性。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 August 6, 2024.

為了方便那些正在收聽重播的人，本次電話會議將於 2024 年 8 月 6 日舉行並錄音。

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

此後，該公司可能發布了與所討論主題相關的其他公告。請參考該公司最新的新聞稿和目前向 SEC 提交的文件。Supernus 不承擔任何更新這些前瞻性聲明的義務，除非適用的證券法要求。我現在將電話轉給傑克。

Thank you, Peter. Good afternoon, everyone, and thanks for taking the time to join us on today's call. In the second quarter of 2024, we delivered strong net sales growth from our key growth drivers, Qelbree and Gocovri, and continue to advance our product pipeline, including SPN-817 for treatment-resistant seizures and SPN-820 for depression.

謝謝你，彼得。大家下午好，感謝您抽空參加我們今天的電話會議。2024 年第二季度，我們的主要成長動力Qelbree 和Gocovri 帶來了強勁的淨銷售成長，並繼續推進我們的產品線，包括用於難治性癲癇發作的SPN-817 和用於憂鬱症的SPN-820。

Total revenues, excluding Trokendi XR and Oxtellar XR, increased 32% in the second quarter. Driving this growth was Qelbree's strong performance with 26% growth in prescriptions, as reported by IQVIA, and 92% growth in net sales.

不包括 Trokendi XR 和 Oxtellar XR 的總收入在第二季度增長了 32%。推動這一成長的是 Qelbree 的強勁業績，根據 IQVIA 報告，處方量成長 26%，淨銷售額成長 92%。

Prescriptions reached an all-time quarterly high of $184,342 and net sales were $59 million. In the first six months of 2024, Qelbree prescriptions grew by 28% compared to the same period last year, and net sales were $105 million, representing an 84% growth over the same period last year.

處方藥銷售額達到 184,342 美元，創下季度歷史新高，淨銷售額為 5,900 萬美元。2024年前六個月，Qelbree處方量較去年同期成長28%，淨銷售額為1.05億美元，較去年同期成長84%。

Growth in net sales of Qelbree in the second quarter of 2024 benefited from both prescription growth and gross-to-net improvements compared to the same period last year. Gross-to-net deductions during the second quarter of this year were below our target range of 50% or 55%.

與去年同期相比，Qelbree 2024 年第二季淨銷售額的成長得益於處方數量的成長和毛淨銷售額的改善。今年第二季的總扣除額低於我們 50% 或 55% 的目標範圍。

We saw a more favorable product returns trend with initial launch batches experiencing lower return rates than assumed, and continued lower copay deductions in the quarter. As a result, for the remainder of 2024, we expect the gross-to-net for Qelbree to be in the 45% to 50% range, with fluctuations that you would typically expect on a quarterly basis.

我們看到了更有利的產品退貨趨勢，最初推出的批次退貨率低於預期，並且本季自付額扣除額持續降低。因此，在 2024 年剩餘時間內，我們預計 Qelbree 的毛淨比將在 45% 至 50% 的範圍內，波動程度與您通常預期的季度波動相同。

During the second quarter, Qelbree also expanded its base of prescribers, ending the quarter with approximately 28,326 prescribers, up from 27,138 in the first quarter of this year. Prescriptions from adult patients now account for approximately 32% of Qelbree's total prescriptions.

第二季度，Qelbree 也擴大了處方醫生基礎，截至本季末，處方醫生數量約為 28,326 名，高於今年第一季的 27,138 名。目前，來自成人患者的處方約佔 Qelbree 總處方的 32%。

Switching now to Gocovri, net sales increased to $32 million in the second quarter of 2024, representing a healthy increase of 10% over the same period in 2023, and reflecting recovery from some of the negative factors the brand faced in the first quarter of 2024.

現在轉向 Gocovri，2024 年第二季的淨銷售額增至 3,200 萬美元，較 2023 年同期健康成長 10%，反映出該品牌已從 2024 年第一季面臨的一些負面因素中恢復過來。

As you recall, earlier this year, we saw a significant increase in sample distribution by physicians to patients to help them through their out-of-pocket expenses in the first quarter. This negatively impacted our prescriptions in the first quarter, but reversed in the second quarter as patients started transitioning from their samples to refilling their prescriptions.

正如您所記得的，今年早些時候，我們看到醫生向患者分發的樣本數量顯著增加，以幫助他們支付第一季的自付費用。這對我們第一季的處方產生了負面影響，但隨著患者開始從樣本轉向重新配藥，第二季度發生了逆轉。

Switching to our legacy products, Oxtellar XR net sales for the second quarter of 2024 were $30 million, compared to $24 million in the second quarter of last year. And for Trokendi XR, second quarter net sales were $17 million, down by 12% from the same quarter last year. For the first 6 months of 2024, net sales of Trokendi XR were down 39%.

轉向我們的傳統產品，Oxtellar XR 2024 年第二季的淨銷售額為 3000 萬美元，而去年第二季為 2400 萬美元。Trokendi XR 第二季淨銷售額為 1,700 萬美元，比去年同期下降 12%。2024 年前 6 個月，Trokendi XR 的淨銷售額下降了 39%。

We expect further erosion in Trokendi XR sales and the entry of Oxtellar XR genetics later this year. Given the trends in the first half of 2024, we now anticipate combined net sales of Trokendi XR and Oxtellar XR in 2024 to be in the range of $135 million to $145 million.

我們預計 Trokendi XR 的銷量將進一步下降，並且 Oxtellar XR Genetics 的進入將在今年稍後進行。鑑於 2024 年上半年的趨勢，我們現在預計 2024 年 Trokendi XR 和 Oxtellar XR 的合併淨銷售額將在 1.35 億美元至 1.45 億美元之間。

Regarding SPN-830, we resubmitted the NDA last week and expect to learn from the FDA in a few weeks whether this submission will be considered as a Class I requiring a two month review, or Class II requiring a 6 months review. We remain committed to Parkinson's patients who lead this potential new treatment option. Moving on to our CNS pipeline of novel product candidates, we have exciting catalysts coming up in the next 6 to 12 months.

關於 SPN-830，我們上週重新提交了 NDA，並期望在幾週內從 FDA 獲悉該提交是否將被視為需要兩個月審查的 I 類，或需要 6 個月審查的 II 類。我們仍然致力於為帕金森氏症患者提供這種潛在的新治療選擇。繼續我們的中樞神經系統候選產品管道，我們將在未來 6 至 12 個月內推出令人興奮的催化劑。

For 820, the company expects to provide data from its Phase 2b study in adults with treatment-resistant depression in the first half of 2025. Three-quarters of the targeted number of patients are now enrolled in the study. Also enrollment in the Phase 2 open-label study in patients with major depressive disorder is ongoing, and top line results from that study are expected by the end of this year.

對於 820，該公司預計將在 2025 年上半年提供針對成人難治性憂鬱症患者的 2b 期研究數據。目前四分之三的目標患者已參與研究。此外，針對重度憂鬱症患者的二期開放標籤研究的入組工作正在進行中，預計該研究的頂線結果將於今年年底獲得。

In May 2024, we announced data from the planned interim analysis of our exploratory open-label Phase 2a study of SPN-817 for treatment-resistant seizures. The interim analysis was based on 41 enrolled subjects, of which 19 completed the maintenance period at that time.

2024 年 5 月，我們公佈了 SPN-817 治療難治性癲癇的探索性開放標籤 2a 期研究計畫的中期分析數據。中期分析是根據 41 名入組受試者，其中 19 名當時完成了維持期。

We continue to expect top line results for the full study in the second half of this year. In addition, the Phase 2b randomized double-blind placebo-controlled study with SPN-817 in patients with treatment-resistant focal seizures is expected to start by the end of 2024.

我們繼續期待今年下半年全面研究的主要結果。此外，針對難治性局部癲癇患者的 SPN-817 2b 期隨機雙盲安慰劑對照研究預計將於 2024 年底開始。

Also we plan to initiate a Phase 1 single-dose study of SPN-443 in healthy adults following submission of an IND. SPN-443 is our newest stimulant-like product candidate for ADHD and other CNS disorders. Finally, we remain active in corporate development, looking for strategic opportunities to further strengthen our future growth and leadership position in CNS.

我們也計劃在提交 IND 後在健康成人中啟動 SPN-443 的 1 期單劑量研究。SPN-443 是我們針對 ADHD 和其他中樞神經系統疾病的最新類興奮劑候選產品。最後，我們仍然積極參與企業發展，尋找策略機遇，以進一步加強我們在中樞神經系統領域的未來成長和領導地位。

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

現在，我將把電話轉給提姆。

Thank you, Jack. Good afternoon, everyone. As I review our second quarter 2024 results, please refer to today's press release and 10-Q that were filed earlier today.

謝謝你，傑克。大家下午好。在我回顧 2024 年第二季業績時，請參閱今天早些時候提交的新聞稿和 10-Q。

Total revenue for the second quarter of 2024 was $168.3 million, compared to $135.5 million in the same quarter last year. Total revenue in the second quarter of 2024 was comprised of net product sales of $162.5 million, and royalty, licensing and other revenues of $5.8 million.

2024 年第二季的總營收為 1.683 億美元，去年同期為 1.355 億美元。2024 年第二季的總收入包括 1.625 億美元的產品淨銷售額以及 580 萬美元的特許權使用費、許可和其他收入。

The increase in net product sales was primarily due to the increase in net product sales of our growth products, Qelbree and GOCOVRI, as well as Oxtellar XR. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the second quarter of 2024 increased 32% compared to the same quarter last year.

產品淨銷售額的成長主要是由於我們的成長產品 Qelbree 和 GOCOVRI 以及 Oxtellar XR 的淨產品銷售額的成長。剔除 Trokendi XR 和 Oxtellar XR 的產品淨銷售額，2024 年第二季總營收較去年同期成長 32%。

For the second quarter of 2024, combined R&D and SG&A expenses were $112.1 million, as compared to $111.2 million for the same quarter last year. The slight increase was primarily due to R&D spend associated with clinical programs for SBN-817 and SBN-820 as we continue to progress our pipeline. Operating earnings on a GAAP basis for the second quarter of 2024 was $22.6 million, as compared to an operating loss of $17.6 million for the same quarter last year.

2024 年第二季度，研發與銷售、一般管理費用合計為 1.121 億美元，去年同期為 1.112 億美元。略有增加主要是由於我們繼續推進我們的管道，與 SBN-817 和 SBN-820 臨床項目相關的研發支出。2024 年第二季以 GAAP 計算的營運利潤為 2,260 萬美元，而去年同期營運虧損為 1,760 萬美元。

Income tax expense in the second quarter of 2024 was $6.4 million. GAAP net earnings was $19.9 million for the second quarter of 2024 or $0.36 per diluted share compared to a GAAP net loss of $831,000 or $0.02 loss per diluted share in the same quarter last year.

2024 年第二季的所得稅費用為 640 萬美元。公認會計原則2024 年第二季淨利為 1,990 萬美元，或稀釋後每股虧損 0.36 美元，而去年同期的 GAAP 淨虧損為 831,000 美元，或稀釋後每股虧損 0.02 美元。

On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration and depreciation, adjusted operating earnings for the second quarter of 2024 was $45.5 million compared to $10 million in the same quarter last year.

以非公認會計準則（不包括無形資產攤提、股權激勵、或有對價和折舊）計算，2024 年第二季調整後營業利潤為 4,550 萬美元，而去年同期為 1,000 萬美元。

Total revenues for the six months ended June 30, 2024, were $312 million compared to $289.3 million in the same period last year. Total revenues were comprised of net product sales of $301 million, and royalties, licensing and other revenue of $11 million.

截至 2024 年 6 月 30 日的六個月總收入為 3.12 億美元，而去年同期為 2.893 億美元。總收入包括 3.01 億美元的產品淨銷售額，以及 1,100 萬美元的特許權使用費、授權和其他收入。

Compared to second quarter 2024 results, the 12% increase in net product sales was primarily due to the increase in net product sales of Qelbree, Gocovri and Oxtellar XR. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenues for the 6 months ended June 30, 2024, increased 22% compared to the same period last year.

與 2024 年第二季業績相比，產品淨銷售額成長 12%，主要是由於 Qelbree、Gocovri 和 Oxtellar XR 的產品淨銷售額增加。不含 Trokendi XR 和 Oxtellar XR 的產品淨銷售額，截至 2024 年 6 月 30 日的 6 個月總收入較去年同期成長 22%。

Combined R&D and SG&A expenses for the 6 months ended June 30, 2024 were $223.5 million as compared to $218 million for the same period last year. Again, this increase was primarily due to R&D expenses associated with clinical programs for SBN-817 and SBN-820 as we continue to progress our pipeline.

截至 2024 年 6 月 30 日的 6 個月，研發與銷售、一般行政費用合計為 2.235 億美元，去年同期為 2.18 億美元。同樣，這一增長主要是由於我們繼續推進我們的管道，與 SBN-817 和 SBN-820 臨床項目相關的研發費用。

Operating earnings on a GAAP basis for the six months ended June 30, 2024, were $19.4 million as compared to an operating loss of $12.4 million for the same period last year. That is a $31.8 million increase in operating earnings compared to the same period last year.

截至 2024 年 6 月 30 日的六個月，按 GAAP 計算的營運利潤為 1,940 萬美元，而去年同期的營運虧損為 1,240 萬美元。與去年同期相比，營業利潤增加了 3,180 萬美元。

For the six months ended June 30, 2024, we reported income tax expense of $6.5 million. GAAP net earnings were $20 million for the six months ended June 30, 2024, or $0.36 per diluted share, compared to $16.1 million or $0.29 per diluted share in the same period last year.

截至 2024 年 6 月 30 日的六個月，我們報告的所得稅費用為 650 萬美元。公認會計原則截至 2024 年 6 月 30 日的六個月淨利潤為 2,000 萬美元，即稀釋後每股收益 0.36 美元，而去年同期淨利潤為 1,610 萬美元，即稀釋後每股收益 0.29 美元。

On a non-GAAP basis, which again excludes amortization, intangibles, share-based comp, contingent consideration and depreciation, adjusted operating earnings were $67.7 million compared to $40.5 million in the same period last year. That is a 67% increase in adjusted operating earnings compared to the same period last year.

以非公認會計準則（同樣不包括攤提、無形資產、股份補償、或有對價和折舊）計算，調整後營業利潤為 6,770 萬美元，而去年同期為 4,050 萬美元。與去年同期相比，調整後營業利潤成長了 67%。

As of June 30, 2024, the company had approximately $347.2 million in cash, cash equivalents, and current and long-term marketable securities compared to $271.5 million as of December 31, 2023. This increase was primarily due to cash generated from operations.

截至2024年6月30日，該公司擁有約3.472億美元的現金、現金等價物以及當前和長期有價證券，而截至2023年12月31日為2.715億美元。這一增長主要是由於營運產生的現金。

It should be noted that we have generated approximately $200 million in cash from operations in the past 18 months. Because of that, the company has a strong balance sheet with no debt, with significant financial flexibility for potential M&A and other growth opportunities.

值得注意的是，我們在過去 18 個月的營運中產生了約 2 億美元的現金。因此，該公司擁有強大的資產負債表，沒有債務，為潛在的併購和其他成長機會提供了巨大的財務靈活性。

Now turning to guidance. For full year 2024, the company raises its financial guidance for total revenue and GAAP and non-GAAP operating earnings while reiterating combined R&D and SG&A expenses. As a result, we expect total revenue to range from $600 million to $625 million, up from the previous range of $580 to $620 million, comprised of net product sales, royalties, licensing and other revenue.

現在轉向指導。對於 2024 年全年，該公司提高了總收入以及 GAAP 和非 GAAP 營運收益的財務指引，同時重申了研發和 SG&A 合併費用。因此，我們預計總收入將從先前的 580 美元至 6.2 億美元增加到 6 億美元至 6.25 億美元，其中包括產品淨銷售額、特許權使用費、授權和其他收入。

For the full year 2024, we expect combined R&D and SG&A expenses to range from $430 million to $460 million. Overall, we expect full year 2024 GAAP operating earnings to range from breakeven to $20 million, and non-GAAP operating earnings to range from $100 million to $125 million.

對於 2024 年全年，我們預計研發和銷售、一般行政費用總計介於 4.3 億至 4.6 億美元之間。整體而言，我們預計 2024 年全年 GAAP 營業利潤將在損益兩平至 2,000 萬美元之間，非 GAAP 營業利潤將在 1 億美元至 1.25 億美元之間。

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

請參閱本次電話會議之前發布的收益新聞稿，其中確定了 GAAP 和非 GAAP 之間的各種調整項目範圍。現在，我將把電話轉回給接線員進行問答。

(Operator Instructions)

（操作員說明）

Andrew Tsai, Jefferies.

安德魯·蔡，杰弗里斯。

Hi, good afternoon. Congrats on a nice quarter, and thanks for taking my questions. The first one is on SPN-830, the apomorphine pump. Congrats on resubmitting that. Just wanted to gauge your level of confidence it will be approved this time.

嗨，下午好。恭喜您度過了一個愉快的季度，並感謝您回答我的問題。第一個是 SPN-830，即阿撲嗎啡幫浦。恭喜您重新提交。只是想衡量一下您對這次獲得批准的信心程度。

It's kind of interesting, since we know the competitor also received a CR recently. So maybe talk about your level of confidence about this? Thanks.

這很有趣，因為我們知道競爭對手最近也收到了 CR。那麼可以談談您對此的信心程度嗎？謝謝。

Yes, sure. A couple things. I mean, the first time we got a CRL, I'll try to give the example. It probably was a few pages. This time we got the CRL, it was maybe half a page, give or take, just to make an example of the number of issues we're dealing with.

是的，當然。有幾件事。我的意思是，當我們第一次獲得 CRL 時，我會嘗試舉一個例子。大概有幾頁。這次我們收到了 CRL，大概有半頁，只是為了舉例說明我們正在處理的問題數。

So certainly, with this resubmission, the number of issues we're dealing with was much a lower number of items and issues that we had to address.

當然，透過這次重新提交，我們正在處理的問題數量大大減少了我們必須解決的項目和問題的數量。

Second thing is we did have a meeting with the FDA before the resubmission to make sure we have the fullest level of confidence before we resubmit. So we feel pretty good about the filing right now and our chances of getting approved.

第二件事是，我們在重新提交之前確實與 FDA 進行了一次會議，以確保我們在重新提交之前擁有最大程度的信心。因此，我們對目前的申請以及獲得批准的機會感到非常滿意。

Of course, as I mentioned in our remarks, what we're still not sure about is whether it will be a Class I or Class II resubmission, but hopefully we'll have that piece of information in the next few weeks when the FDA accepts the filing and assigns a PDUFA date for the review.

當然，正如我在發言中提到的，我們仍然不確定它是 I 類還是 II 類重新提交，但希望我們能在接下來的幾週內 FDA 接受時獲得該資訊提交並指定 PDUFA 審核日期。

Makes sense. Thanks. And shifting to 817, we're going to have the full Phase 2a data cut later this year. Can you remind us, I think 19 of 41 patients completed the maintenance period. How many more patients do you think will be completing that maintenance period? And how many more specifically at the 3 to 4 milligram dose, the high doses?

有道理。謝謝。轉向 817，我們將在今年稍後進行完整的 Phase 2a 數據削減。您能否提醒我們，我認為 41 名患者中有 19 名完成了維持期。您認為還有多少患者會完成維持期？具體來說，3 到 4 毫克的高劑量有多少？

Yes, at that time back in May when we recorded the interim results, in addition to the 19, we had about 7 or 8, if I remember the number correctly, of patients who were still in the study at various stages.

是的，在五月我們記錄中期結果的時候，除了這 19 名患者之外，如果我沒記錯的話，我們還有大約 7 或 8 名患者仍在不同階段的研究中。

So we would expect when we report the full results to have at least another maybe, I don't know, 5, 6, depending on how many discontinue or how many stay in all the stages of the study.

因此，我們預計，當我們報告完整結果時，至少會有另一個，我不知道，5個、6個，取決於有多少人停止或有多少人留在研究的所有階段。

But we should have a good handful of people in addition to the 19 that we will report on. So that's -- that will complete the initial portion of the study, just to clarify. The second portion was the extension, which we talked about back in May, where we are going to test a couple of strategies.

但除了我們將要報告的 19 個人之外，我們還應該有很多人。所以這將完成研究的初始部分，只是為了澄清。第二部分是擴展，我們在五月就討論過這個問題，我們將測試一些策略。

One of them is adding an anti-rheumatic where we try to address the nausea and so forth. So that portion of the study has already started, but we won't have data in the fourth quarter or before year end for this year, just to clarify that.

其中之一是添加抗風濕藥，我們試圖解決噁心等問題。因此，這部分研究已經開始，但我們不會在今年第四季或年底之前獲得數據，只是為了澄清這一點。

There are two different pieces of the study. The initial one, which we will report on, but the extension, which we added in May, we will not have the data to report on that.

研究有兩個不同的部分。我們將報告最初的一個，但我們在五月添加的擴展，我們將沒有數據來報告。

And then last one is on 820, the depression asset. You're having pulsatile data in 40 patients with MDD later this year. Can you just remind us how long the study is and what kind of MADRS or HAM-D efficacy benefit you want to see at the end of the study? What would be positive data to you and why?

最後一個是 820，蕭條資產。今年晚些時候，您將獲得 40 名 MDD 患者的脈動數據。您能否提醒我們研究持續多長時間以及您希望在研究結束時看到什麼樣的 MADRS 或 HAM-D 療效益處？什麼數據對您來說是正面的？

Yes. I mean, this is a short study. I think it's about 10 days treatment, so it's not a very long study. It is open-label, about 40 patients that we are targeting. So we think we have a very good chance we will be able to report before year end.

是的。我的意思是，這是一項簡短的研究。我認為治療時間大約是 10 天，所以這不是一個很長的研究。這是開放標籤的，我們的目標是大約 40 名患者。因此，我們認為我們很有可能在年底前提交報告。

And as far as, I mean, the number of the reduction in the scales and what would we expect, of course, the larger the better, especially that it is open-label. So we would hope to see certainly a large improvement on MADRS versus if it were a placebo control.

我的意思是，就規模減少的數量以及我們期望的情況而言，當然，越大越好，尤其是它是開放標籤的。因此，與安慰劑對照組相比，我們希望看到 MADRS 確實有很大的改善。

Thanks again.

再次感謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Thanks. A couple of questions on Qelbree. So with the back-to-school season coming up, help us understand your expectations for acceleration in volumes, particularly with the different gross-to-net framework that you've been talking about?

謝謝。關於 Qelbree 的幾個問題。因此，隨著返校季的到來，請幫助我們了解您對銷售的加速成長期望，特別是您一直在談論的不同的總淨值框架？

And also in the context of, I believe, last back-to-school season, the Rx growth or acceleration was a bit muted. So help us understand how you're thinking about this year's back-to-school season? That's number one.

我相信，在上個返校季的背景下，處方藥的成長或加速有點減弱。那麼請幫助我們了解您如何看待今年的返校季？這是第一名。

And then number two is how much of the growth through the back half of the year-on-year growth is volumes? And how much of it is improvement in gross-to-net? And just help us better understand how we should be thinking about Qelbree.

第二個問題是，後半段年成長中有多少是銷售成長？其中有多少是毛淨值的改善？只是幫助我們更好地理解我們應該如何思考 Qelbree。

In other words, what I guess I'm trying to get at is, is Qelbree a volume-growth product going forward, or is a lot of the growth that's being captured is really just a function of improved economics? So that's just did apply to this year, but also how you're thinking about the product beyond this year? Thanks.

換句話說，我想我想知道的是，Qelbree 是一款未來銷售成長的產品，還是正在捕捉的大部分成長實際上只是經濟改善的結果？這確實適用於今年，但您對今年以後的產品有何看法？謝謝。

Yes. I mean, as an overall comment on the prescription growth of Qelbree, I mean, as we mentioned in the first half, we grew by about 28%. So we continue to expect to have robust growth in prescriptions versus last year.

是的。我的意思是，作為對 Qelbree 處方增長的總體評論，我的意思是，正如我們在上半年提到的，我們增長了約 28%。因此，我們繼續預期處方量與去年相比將出現強勁成長。

As far as specifically the back-to-school seasons, you're absolutely right. Last year, overall, the ADHD market, there was a much softer back-to-school season than normally we would see.

就返校季而言，你是完全正確的。整體而言，去年過動症市場的返校季比我們平常看到的要溫和得多。

And actually, looking at year-to-date ADHD market growth, this year so far it's up 8% in 2024 year-to-date in the first half of this year versus 2023. And if you might remember, the ADHD market grew only by 3% in 2023 in total.

事實上，從年初至今的 ADHD 市場成長來看，今年上半年迄今，2024 年的 ADHD 市場較 2023 年成長了 8%。如果您還記得的話，ADHD 市場到 2023 年總共僅成長 3%。

So this year already is showing a recovery in the market, in the overall market in general, at least in the first half of 2024, at a much higher growth rate than last year. So I'm hoping that the back-to-school season would be back to what normal growth would be versus what happened in 2023.

所以今年已經呈現出市場的復甦，整體市場來說，至少在2024年上半年，成長速度比去年高出很多。因此，我希望返校季能夠恢復到 2023 年的正常成長水準。

I mean in 2023, we actually saw some decline actually in the ADHD market with the measurement that we talked about it back then, which was June through September.

我的意思是，到 2023 年，根據我們當時討論的衡量標準（即 6 月至 9 月），我們實際上看到 ADHD 市場出現了一些下滑。

It was not necessarily a calendar quarter to get a better feel for what happened in the back-to-school, while recovery continued to grow last year, and it grew by about 19% in the back-to-school season. So I'm hoping that the market does better, and, of course, that means we will also do better than we did last year as far as growth.

不一定是一個日曆季度才能更好地了解返校期間發生的情況，而去年的復甦繼續增長，並且在返校季節增長了約 19%。所以我希望市場表現更好，當然，這意味著我們在成長方面也會比去年做得更好。

But the short answer, I mean, to your question is, the growth in Qelbree is not just improvement in gross-to-net. Certainly, we continue to have robust growth. I mean we're already in year 4 as far as the launch of this product, and we're still delivering 20%-plus growth in prescriptions.

但我的意思是，對於你的問題，簡短的回答是，Qelbree 的成長不僅僅是毛淨值的提高。當然，我們繼續保持強勁成長。我的意思是，就該產品的推出而言，我們已經進入了第 4 年，而且我們的處方數量仍保持 20% 以上的增長。

And from a penetration perspective, we still have a lot of room to go here as far as the potential of this product and its penetration in the market, adult and pediatric at the same time. Hopefully, that touches on all the questions.

從滲透率的角度來看，就該產品的潛力及其在成人和兒童市場的滲透率而言，我們還有很大的發展空間。希望這涉及到所有問題。

And if I just may sneak in a quick follow-up. The gross-to-net, I mean it's getting below 50%, I mean, which is better than what you had cited as a target in the past. I mean is that 45% to 50% -- and just to be clear, that's your view of steady-state gross-to-net over the long term for the product? And maybe I'll ask it differently. Is there room for even further improvement?

如果我可以偷偷地進行快速跟進。我的意思是，毛淨比低於 50%，這比您過去提到的目標要好。我的意思是 45% 到 50%——澄清一下，這就是您對產品長期穩定毛淨比的看法？也許我會問不同的問題。還有進一步改進的空間嗎？

Yes, I mean, what I referred to in my prepared remarks, which was the issue of return, just to explain it a little bit more. Typically, when you first launch a product, you make an assumption on how much of these initial batches that you ship out, how much of those could potentially come back at some point from a return perspective.

是的，我的意思是，我在準備好的發言中提到了退貨問題，只是為了多解釋一下。通常，當您第一次推出產品時，您會假設您發出了多少初始批次，從退貨的角度來看，其中有多少可能會在某個時候返回。

And you book it, you enter in your books as far as potential liability, accruals, what have you on these returns. And then as time goes on, these batches, they will either be consumed or they expire because time goes on and they have a certain fixed expiration date. So as they approach or go beyond the expiration date, basically they're not going to be returned anymore.

你預訂它，你在你的帳簿中輸入潛在的責任、應計費用，以及你在這些回報上有什麼。然後隨著時間的推移，這些批次，它們要么被消耗掉，要么過期，因為時間在流逝，它們有一個固定的過期日期。因此，當它們接近或超過有效期時，基本上不會再退回。

Or if you do have much lower experience from a return perspective versus the initial assumption, that's when you can take back some of that. So these are the things that could potentially continue that way. I mean, there is a possibility we continue to benefit from that trend in the next quarter or so.

或者，如果從回報的角度來看，與最初的假設相比，您的經驗確實要低得多，那麼您就可以收回其中的一些經驗。因此，這些事情可能會繼續這樣下去。我的意思是，我們有可能在下個季度左右繼續從這一趨勢中受益。

So it may not be at one time, but we can only see that when we get the data every quarter. And therefore, back to your question on an ongoing basis would the target be 45% to 50%?

所以可能不是一次性的，而是每季拿到數據的時候我們才能看到。因此，回到你的問題，目標是 45% 到 50% 嗎？

I sure hope so. I mean, I sure hope that next quarter gives us even more confidence. And in that case, we will emphasize or confirm that that probably is our long-term target versus the 50% to 55%.

我當然希望如此。我的意思是，我當然希望下個季度能讓我們更有信心。在這種情況下，我們將強調或確認這可能是我們的長期目標，而不是 50% 到 55%。

Okay, that's helpful. Thank you.

好的，這很有幫助。謝謝。

Stacy Ku, TD Cowen.

史黛西·庫，TD·考恩。

Wonderful. I'm Thanks so much for taking our questions. What a great quarter for Qelbree and just a solid net value for prescription. So we have a few follow-ups. Just for Q1, can you just talk a little bit more about what approach you're trying to do to grab share in the back-to-school season?

精彩的。非常感謝您提出我們的問題。對於 Qelbree 來說，這個季度真是太棒了，處方藥的淨值也很可觀。所以我們有一些後續行動。就第一季而言，您能多談談您在返校季節試圖採取什麼方法來搶佔市場份額嗎？

So just to clarify, you said the next quarter or so you could see a benefit in gross-to-net, but do you think any of these back-to-school plans could impact the gross-to-nets in Q3? So this is the first question.

因此，為了澄清一下，您說下個季度左右您可能會看到毛淨值的增長，但您認為這些返校計劃是否會影響第三季度的毛淨值？這是第一個問題。

And then to ask the question a little bit differently, how do you think about your comfort with the $200 million and $220 million consensus rates for Qelbree that you've kind of commented on in the past? Could this be exceeded as we think about just the solid gross-to-net improvements? And then last question is on the adult growth.

然後以稍微不同的方式問這個問題，您如何看待您過去評論過的 Qelbree 2 億美元和 2.2 億美元的共識利率？當我們考慮毛淨值的穩健改善時，這個數字是否會被超越？最後一個問題是關於成人的成長。

Talked about the 32% split, but is this driving the net pricing? Are you seeing kind of encouraging growth, and how should we think about the remainder of the year as you think about really trying to drive that adult launch as well?

談到了 32% 的分成，但這會推動淨定價嗎？您是否看到了令人鼓舞的成長？

Thank you so much. Yes. On the first question as far as the back-to-school programs, I mean it's fairly intense as far as the level of support that we will be going out with and the momentum that we will be building and are building actually as we speak right now in preparation for the back-to-school season. So we will put a lot of investment and effort behind this season, given the importance of the season for the whole year for the brand in general.

太感謝了。是的。關於返校計劃的第一個問題，我的意思是，就我們將提供的支持水平以及我們將建立和正在建立的勢頭而言，正如我們所說的那樣，這是相當強烈的現在正在為返校季做準備。因此，考慮到這個季節對於整個品牌而言的重要性，我們將在這個季節投入大量的投資和精力。

At the same time, we're not neglecting the adult sector -- again, a portion of the business, of course, in Q3, but the top priority is clearly children and pediatric because of the back-to-school. As far as the annual, so to speak, soft guidance or whichever way you want to describe it, the 200 to 220, I mean clearly in the first 6 months, we did 104.5 or 105.

同時，我們並沒有忽視成人市場——當然，這也是第三季業務的一部分，但由於返校，首要任務顯然是兒童和兒科。至於年度，可以說，軟指導或任何你想描述的方式，200 到 220，我的意思是在前 6 個月裡，我們做了 104.5 或 105。

Double that is 210. And of course, you get to add some growth to it. So clearly, we feel comfortable with that range. Is it going to be a little bit closer to the upper range? Hopefully, again, it all depends on the back-to-school season, which was a lot of what we've been talking about today.

加倍即210。當然，你也可以為其添加一些增長。顯然，我們對這個範圍感到滿意。它會更接近上限嗎？再次希望，這一切都取決於返校季節，這也是我們今天討論的許多內容。

If the back-to-school season is really strong this year and not soft like it was last year, maybe we will be closer to the upper end of that range on Qelbree. And then finally, I mean in this past quarter, in the second quarter, to give you an idea, our adult prescriptions or business grew by about 26%. The pediatric grew by about 22%, 23%.

如果今年的返校季真的很強勁，而不是像去年那樣疲軟，也許我們會更接近 Qelbree 的上限。最後，我的意思是在過去的一個季度，在第二季度，給你一個想法，我們的成人處方藥或業務增長了約 26%。兒科成長約22%、23%。

So we had put some more emphasis on the adult patient population in the second quarter as time. So we are experiencing a little bit more growth in adult, but again on a quarter-to-quarter basis, as I mentioned earlier or in previous calls, sometimes we on purpose shift the emphasis one quarter versus another, depending on the seasonality and the importance of that specific patient population.

因此，隨著時間的推移，我們在第二季度更加重視成年患者群體。因此，我們在成人方面經歷了更多的增長，但同樣是在季度與季度的基礎上，正如我之前或在之前的電話會議中提到的，有時我們會根據季節和情況故意將重點轉移到另一個季度。

Thank you.

謝謝。

Annabel Samimy, Stifel.

安娜貝爾·薩米米，斯蒂菲爾。

Hi. Thanks for taking my question. Great quarter on Qelbree. I just want to put a finer point on the adult versus pediatric. To what extent is the adult population driving some of maybe the improved pricing?

你好。感謝您提出我的問題。Qelbree 的很棒的季度。我只是想對成人與兒童進行更詳細的討論。成年人口在多大程度上推動了價格的提高？

Obviously they have higher doses, so potentially a higher price point. And given that that's where a good chunk of the growth was and some of your efforts had been lying in that area, can you maybe share some of the feedback that you're getting from the adult population?

顯然它們的劑量更高，因此價格可能更高。鑑於這就是成長的很大一部分，並且您的一些努力一直在該領域，您能否分享一些您從成年人口獲得的回饋？

Is this an area that you can continue to push? And is there any pushback from the adults in terms of whether they're favoring a stimulant versus a non-stimulant, if they're still transitioning with lower doses than you expected, et cetera, et cetera.

這是您可以繼續推動的領域嗎？成年人是否會反對他們是否喜歡興奮劑而不是非興奮劑，如果他們仍然以低於你預期的劑量進行過渡，等等，等等。

Just trying to understand why, with the growth that you have, why it's still sitting at 32% of your total prescriptions and also with the efforts that you're making last quarter. Thanks.

只是想了解為什麼隨著您的成長，為什麼它仍然佔您總處方量的 32%，以及您上季度所做的努力。謝謝。

Yes. Regarding the price points and so forth, I'll just give you a couple of numbers. I mean these are more gross numbers. But for the adult, I mean we estimate the average blended cost of prescription is around $600, $615. By comparison, it's around $525 for pediatrics.

是的。關於價格等，我只給你幾個數字。我的意思是這些是更多的總數字。但對於成年人來說，我的意思是我們估計處方藥的平均綜合費用約為 600 美元至 615 美元。相比之下，兒科費用約為 525 美元。

So there is about 15%, 17% difference between the price for prescription pediatric versus adult. And that actually is obviously a result of the size of the prescription. So with adults, you normally have 50 to 52 tablets per prescription or capsules per prescription. With pediatric, it's more around the 44, 45 capsules per prescription. So these are some of the metrics.

因此，兒童處方藥與成人處方藥的價格約有 15%、17% 的差異。這實際上顯然是處方大小的結果。因此，對於成人來說，每個處方通常需要 50 至 52 片藥片或每個處方膠囊。對於兒科，每個處方的劑量約為 44、45 粒膠囊。這些是一些指標。

Obviously, it does change over time quarter-to-quarter, but that's where we are right now as far as the pediatric versus adult. As far as the feedback on the adult patient population, I mean very consistent, fairly consistent with the pediatric about the product, its performance, clinical benefits, all of the above, the tolerability and safety.

顯然，它確實會隨著時間的推移而每個季度發生變化，但就兒童與成人而言，這就是我們目前所處的情況。就成人患者群體的回饋而言，我的意思是與兒科有關該產品、其性能、臨床益處、所有上述內容、耐受性和安全性的反饋非常一致、相當一致。

I mean, very, very consistent across all patient populations with both of them showing the growth and acceptance of the product. And by no means we are even anywhere close to the saturation as far as our penetration rates. I mean our market share in adult is very low.

我的意思是，所有患者群體都非常非常一致，他們都顯示出產品的成長和接受度。就滲透率而言，我們還遠遠沒有接近飽和。我的意思是我們在成人市場的份額非常低。

And we have a huge, huge opportunity here for us to continue to push the product. And again, as long as the product continues to perform, we see no reason for it to slow down and try to get a much higher market share penetration within the adult segment.

我們在這裡有一個巨大的機會來繼續推廣該產品。再說一次，只要該產品繼續表現出色，我們認為它沒有理由放慢腳步，並試圖在成人細分市場中獲得更高的市場份額滲透率。

Got it. And maybe you can just share what your expectations are for the level of penetration you might have in that adult population in either for the year or for the long-term outlook. Is this still going to be a 32% type of -- well, I mean is it going to account still for about 32% of your prescriptions or do you expect that number to continue to go up through the year?

知道了。也許您可以分享您對今年或長期前景在成年人口中的滲透率水平的期望。這是否仍然是 32% 的類型——嗯，我的意思是它仍然會佔您處方藥的 32% 左右，還是您預計這個數字在今年會繼續上升？

Yes. I mean we do expect it to go up eventually, whether through this year or next quarter or the quarter after. But more on a long-term basis, definitely we would expect and we certainly will be working pretty hard to get that portion to be a bigger part of the mix.

是的。我的意思是，我們確實預計它最終會上升，無論是今年、下個季度還是下個季度。但從長遠來看，我們肯定會期望並且我們肯定會非常努力地使這部分成為組合中更大的一部分。

So will Qelbree end up being a 40% adult and 60% pediatric where the market is pretty much 67% adult and 33% pediatric? Probably.

那麼，Qelbree 最終會成為 40% 成人和 60% 兒童的市場，而市場幾乎是 67% 成人和 33% 兒童的市場嗎？大概。

I mean we are a non-stimulant anyway in general. So you are going to have some bias of the business being a little bit more pediatric than adult in general, generally speaking. But certainly we are pushing pretty hard to get that 32% much higher as being part of the mix.

我的意思是，總的來說，我們無論如何都是非興奮劑。因此，一般來說，你會對這個行業產生一些偏見，認為它比成人產業更小兒科。但當然，我們正在努力爭取將 32% 的比例提高到更高的水平，作為混合的一部分。

And as far as the adult in general, as I mentioned earlier, I mean the satisfaction, the performance, everything is very similar to what we are seeing with the pediatrics. So we see no reason why we should not be able to continue to grow within the adult market.

就一般成人而言，正如我之前提到的，我指的是滿意度、表現，一切都與我們在兒科看到的非常相似。因此，我們認為我們沒有理由不能在成人市場繼續成長。

At this point, our market share within the adult market is around 0.3% in pediatrics and the 2% give or take. So we continue to look for the whole brand Qelbree, you might remember we talked about somewhere between 4% or 5% market share or could be as high as 10% market share of the total ADHD market. So we clearly have a long way to go here with Qelbree.

目前，我們在成人市場的市佔率約為 0.3%，在兒科市場的市佔率為 2%。因此，我們繼續尋找整個品牌 Qelbree，您可能還記得我們談到整個 ADHD 市場的 4% 或 5% 的市場份額，或者可能高達 10% 的市場份額。因此，我們與 Qelbree 的合作顯然還有很長的路要走。

Okay. And if I can just ask a quick question on SPN-830, I guess this is several times now through the review process. Are there any indications from FDA on the breadth of the population that might be included in the label? I'm not sure if you ever got to that point where you got to label discussions, but is FDA considering a broader label or is it still mostly in the severe camp?

好的。如果我能就 SPN-830 提出一個簡單的問題，我想這已經是審查過程中的好幾次了。FDA 是否有任何關於標籤中可能包含的人群範圍的指示？我不確定你是否已經到了標籤討論的地步，但 FDA 是否正在考慮更廣泛的標籤，或者仍然主要處於嚴重陣營？

Yes. I mean at this point, it is really premature for us to make any comment on that because we haven't gotten that far as far as discussions. So we really don't know at this point.

是的。我的意思是，在這一點上，我們對此發表任何評論確實為時過早，因為我們還沒有進行到如此程度的討論。所以我們現在真的不知道。

Great, thank you.

太好了，謝謝。

Thank you. This concludes the question-and-answer session. I would now like to turn it back to Jack Khattar for closing remarks.

謝謝。問答環節到此結束。現在我想請傑克·卡達（Jack Khattar）發表結束語。

In concluding our call this afternoon, we thank you for joining us to learn about our strong performance in the second quarter and first half of this year. The company continues to execute remarkably well through a multi-year transition and the loss of exclusivity on two of its legacy products.

在今天下午的電話會議結束時，我們感謝您加入我們，了解我們今年第二季和上半年的強勁表現。經過多年的轉型和失去兩種傳統產品的獨家經營權，該公司繼續表現出色。

The company has generated strong positive cash flows behind the strength of its portfolio, particularly our growth products and the efficiency of its operations. In addition, we are excited about our progress on the pipeline across several programs. These programs will be generating significant data over the next 6 to 12 months.

該公司憑藉其投資組合的實力，特別是我們的成長產品和營運效率，產生了強勁的正現金流。此外，我們對多個專案的進展感到興奮。這些計劃將在未來 6 至 12 個月內產生重要數據。

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。我們期待下次通話時向您通報最新情況。

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

感謝您參加今天的會議。我們的計劃到此結束。您現在可以斷開連線。