Supernus Pharmaceuticals Inc (SUPN) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to Supernus Pharmaceuticals Fourth Quarter and Full Year 2022 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference call is being recorded.

下午好，歡迎來到 Supernus Pharmaceuticals 第四季度和 2022 年全年財務業績電話會議。 （操作員說明）作為提醒，正在錄製此電話會議。

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

我現在想將會議轉交給 Supernus Pharmaceuticals 的 ICR Westwicke 投資者關係代表的 Peter Vozzo。先生，您可以開始了。

Thank you, Chris. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' Fourth Quarter and Full Year 2022 Financial Results Conference Call. Today, after the close of the market, the company issued a press release announcing these results.

謝謝你，克里斯。大家下午好，感謝您今天加入我們參加 Supernus Pharmaceuticals 第四季度和全年 2022 年財務業績電話會議。今天，收市後，該公司發布了一份新聞稿，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.

今天與我通電話的是 Supernus 的首席執行官 Jack Khattar；和首席財務官 Tim Dec。今天的電話會議通過公司網站 ir.supernus.com 的投資者關係部分公佈。

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. 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.

在此次電話會議期間，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 Supernus 當前對現有趨勢和信息的看法。任何此類前瞻性陳述都不是對未來業績的保證，並且涉及風險和不確定性，包括公司最新提交給美國證券交易委員會的文件的風險因素部分中提到的風險和不確定性。實際結果可能與這些前瞻性陳述中預測的結果存在重大差異。

For the benefit of those of you who may be listening to the replay, this call is being held and recorded on February 28, 2023. 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.

為了那些可能正在收聽重播的人的利益，本次電話會議將於 2023 年 2 月 28 日舉行並進行錄音。此後，公司可能已經發布了與所討論主題相關的其他公告。請參考公司最近的新聞稿和當前提交給美國證券交易委員會的文件。除非適用的證券法要求，否則 Supernus 拒絕承擔任何更新這些前瞻性陳述的義務。

I'll now turn the call over to Jack.

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 as we discuss our 2022 fourth quarter and full year results. I would like to first make a few comments about the full year of 2022 and then get into more details about specific product updates and accomplishments.

謝謝你，彼得。大家下午好，感謝您抽出寶貴時間加入我們討論 2022 年第四季度和全年業績。我想首先對 2022 年全年做一些評論，然後再詳細介紹具體的產品更新和成就。

We closed another great year preparing Supernus for the loss of exclusivity of Trokendi XR and the transition to our growth brands. I'm proud of our employees for excellent planning and execution over the past few years putting Supernus in the best possible position to successfully transition from our mature brands and setting the stage to deliver double-digit growth in 2024 and beyond.

我們結束了又一個偉大的一年，讓 Supernus 為失去 Trokendi XR 的獨家經營權和向我們的成長品牌過渡做好準備。我為我們的員工在過去幾年中出色的規劃和執行感到自豪，這使 Supernus 處於最佳位置，可以從我們的成熟品牌成功轉型，並為在 2024 年及以後實現兩位數增長奠定了基礎。

As we exited the fourth quarter of 2022 products acquired or launched since 2020 accounted for approximately 48% of our total net product sales. In total, Supernus achieved in 2022 record revenues of $667 million, up 15% compared to 2021 despite a significant 14% decline or $43.6 million decline in net sales of Trokendi XR. In 2022, we also continued to advance our pipeline assets with our 2 lead product candidates, SPN-820 and SPN-817, now in Phase II development. Both product candidates represent novel therapies in CNS with unique mechanisms of action to treat depression and epilepsy, respectively.

當我們退出 2022 年第四季度時，自 2020 年以來收購或推出的產品約占我們產品淨銷售額總額的 48%。總的來說，儘管 Trokendi XR 的淨銷售額下降了 14% 或 4360 萬美元，但 Supernus 在 2022 年實現了創紀錄的 6.67 億美元收入，比 2021 年增長了 15%。 2022年，我們還繼續推進我們的管道資產，我們的兩個主要候選產品 SPN-820和 SPN-817目前處於二期開發階段。這兩種候選產品代表了中樞神經系統的新療法，分別具有治療抑鬱症和癲癇症的獨特作用機制。

Now starting with an update on Qelbree. 2022 represented a milestone year establishing the product as one of the fastest-growing brands in the ADHD market. Qelbree annual IQVIA prescriptions reached approximately 322,624 prescriptions, representing growth of about 526% compared to 2021. In the fourth quarter 2022, total IQVIA prescriptions for Qelbree reached 117,635 prescriptions, representing a sequential increase of 24% compared to the third quarter of 2022. More importantly, in the most recent month of January 2023, the IQVIA monthly prescriptions reached an all-time high of 42,881. This represents an annual run rate for Qelbree of more than 0.5 million prescriptions.

現在從 Qelbree 的更新開始。 2022 年是具有里程碑意義的一年，使該產品成為 ADHD 市場上增長最快的品牌之一。 Qelbree 年度 IQVIA 處方達到約322,624張處方，與2021年相比增長約526%。2022年第四季度，Qelbree IQVIA 處方總數達到117,635張處方，與2022年第三季度相比環比增長24%。更多重要的是，在最近一個月的 2023 年 1 月，IQVIA 的月度處方達到了 42,881 的歷史新高。這代表 Qelbree 的年運行率超過 50 萬張處方。

Qelbree is off to a great start in 2023, capitalizing on several dynamics that we believe will set up the brand very nicely for continued robust growth in 2023. I will elaborate on each one of these dynamics separately. First, the ADHD market has grown at a much faster rate than we expected over the past 2 years. In 2022, the market grew by 9% in total annual prescriptions reaching more than 90 million prescriptions. This followed another healthy increase in 2021 of 8.5% in total prescriptions.

Qelbree 在 2023 年有了一個良好的開端，利用了我們認為可以很好地建立品牌以在 2023 年持續強勁增長的幾種動力。我將分別詳細說明這些動力中的每一種。首先，ADHD 市場在過去 2 年的增長速度比我們預期的要快得多。到 2022 年，市場每年的處方總量將增長 9%，達到超過 9000 萬張處方。在此之前，2021 年處方藥總量再次健康增長 8.5%。

Second, over the past 12 months, we have seen a steady increase in the average wholesale acquisition cost per prescription for Qelbree, reaching $488 in January 2023 and up by 20% compared to January 2022. This is primarily due to physicians titrating up in dose for pediatric patients closer to an average daily dose of 300-milligram and for adult patients, closer to an average daily dose of 500 milligrams. It is also the result of a 47% sequential quarterly growth and adult prescriptions in the fourth quarter of 2022.

其次，在過去 12 個月中，我們看到 Qelbree 每個處方的平均批發採購成本穩步上升，2023 年 1 月達到 488 美元，比 2022 年 1 月增長 20%。這主要是由於醫生滴定劑量對於接近 300 毫克的平均每日劑量的兒科患者和接近 500 毫克的平均每日劑量的成人患者。這也是 2022 年第四季度 47% 的連續季度增長和成人處方的結果。

With such robust growth, the adult prescriptions represented 22% of total Qelbree's prescriptions in the fourth quarter up from only 3% before the adult launch. During the fourth quarter, the pediatric prescriptions sequential growth was a healthy 19% on top of the strong growth during the back-to-school season in the third quarter of 2022. The third important dynamic is the significant improvement in managed care coverage, which should lead to an increase in the 2023 net price per prescription. At the beginning of 2023, we signed a contract with a second key pharmacy benefit manager which should allow us to get to the target range of 50% to 55% in gross to net that we discussed last year.

憑藉如此強勁的增長，第四季度成人處方藥佔 Qelbree 處方藥總量的 22%，高於成人上市前的 3%。在第四季度，兒科處方在 2022 年第三季度返校季強勁增長的基礎上實現了 19% 的健康增長。第三個重要動力是管理式醫療覆蓋面的顯著改善，這應該會導致 2023 年每個處方的淨價上漲。在 2023 年初，我們與第二個主要藥房福利經理簽署了一份合同，這將使我們能夠達到我們去年討論的 50% 至 55% 的目標範圍。

We are also pleased with the Medicaid approval rate for Qelbree's prescriptions, which is now above 70% with preferred access in several important states. The fourth dynamic that I will highlight is the continued growth in Qelbree's base of prescribers with over 16,822 prescribers in the fourth quarter of 2022, up from 14,265 prescribers in the third quarter of 2022.

我們也對 Qelbree 處方的醫療補助批准率感到滿意，該批准率目前已超過 70%，並在幾個重要州享有優先權。我要強調的第四個動態是 Qelbree 的處方者基礎持續增長，2022 年第四季度有超過 16,822 名處方者，高於 2022 年第三季度的 14,265 名處方者。

In addition to these highlighted dynamics, we are excited about our planned expansion of our sales force in the second quarter of 2023 by approximately 45 sales representatives to give us broader reach and increased capacity to deliver higher frequency on high-decile prescribers. This expansion will allow us to cover more than 50% of the ADHD market. In summary, Qelbree continues to perform across several important growth metrics, giving us confidence in its growth potential in 2023 and, more importantly, in 2024 and beyond.

除了這些突出的動態之外，我們對我們計劃在 2023 年第二季度擴大我們的銷售隊伍約 45 名銷售代表感到興奮，以擴大我們的覆蓋面並提高能力，以更高的頻率向高分位處方者提供服務。這一擴展將使我們能夠覆蓋 50% 以上的 ADHD 市場。總之，Qelbree 在幾個重要的增長指標上繼續表現出色，這讓我們對其在 2023 年，更重要的是在 2024 年及以後的增長潛力充滿信心。

Switching now to GOCOVRI, we are very pleased with the brand's performance in its first year, having gone through the integration process of our acquisition of Adamas and having transitioned to a new sales force. The Supernus commercial organization, including our Parkinson's sales force did an outstanding job integrating the brand and managing to achieve record sales of $104 million while also supporting APOKYN, our second Parkinson's product. In 2022, GOCOVRI delivered strong growth of 19% and 13% in net sales and prescriptions, respectively, compared to 2021 and exited the year with a solid fourth quarter performance with a record high quarterly net sales of $29.2 million.

現在切換到 GOCOVRI，我們對該品牌第一年的表現感到非常滿意，經歷了我們收購 Adamas 的整合過程並過渡到新的銷售團隊。 Supernus 商業組織，包括我們的帕金森氏症銷售人員，在整合品牌方面做得非常出色，並成功實現了創紀錄的 1.04 億美元銷售額，同時還支持我們的第二款帕金森氏症產品 APOKYN。 2022 年，與 2021 年相比，GOCOVRI 的淨銷售額和處方藥分別實現了 19% 和 13% 的強勁增長，並以穩健的第四季度業績結束了這一年，季度淨銷售額達到創紀錄的 2920 萬美元。

Oxtellar XR continues to be steady with net product sales of $115 million for full year 2022, representing a 4% increase compared to 2021. For full year 2022, net product sales for Trokendi XR were $261 million, down from $305 million in 2021. We significantly reduced our in-person sales efforts in the second half of 2022 and continue to provide support to physicians and patients through various sales and marketing programs.

Oxtellar XR 繼續保持穩定，2022 年全年產品淨銷售額為 1.15 億美元，比 2021 年增長 4%。2022 年全年，Trokendi XR 的產品淨銷售額為 2.61 億美元，低於 2021 年的 3.05 億美元。我們我們在 2022 年下半年大幅減少了面對面的銷售工作，並繼續通過各種銷售和營銷計劃為醫生和患者提供支持。

In January 2023, the first generic to 3 out of 4 product strengths of Trokendi XR was introduced. Trokendi XR IQVIA monthly prescriptions for January 2023 were 23,840, declining by 34% compared to January 2022. Based on the most recent IQVIA weekly prescription data for the week ending February 17, Trokendi XR prescriptions declined by 38% compared to the week ending January 13, which is the last week before the generic impact. Based on the generic erosion today and the possibility of other generic entries, we are expecting revenues from Trokendi XR in 2023 to be in the range of $60 million to $80 million.

2023 年 1 月，Trokendi XR 的 4 個產品強度中的 3 個是第一個仿製藥。 Trokendi XR IQVIA 2023 年 1 月的月處方量為 23,840，與 2022 年 1 月相比下降了 34%。根據 IQVIA 截至 2 月 17 日當週的最新每周處方數據，與截至 1 月 13 日當週相比，Trokendi XR 處方量下降了 38% ，這是通用影響前的最後一周。基於今天的仿製藥侵蝕和其他仿製藥進入的可能性，我們預計 Trokendi XR 在 2023 年的收入將在 6000 萬至 8000 萬美元之間。

Moving on to the pipeline. We will be meeting with the FDA in April this year regarding the resubmission of the NDA for SPN-830, our apomorphine infusion device. We will announce the timing of our resubmission after our discussion with the FDA. We initiated the open-label Phase II clinical study with SPN-817 in adult patients with treatment-resistant seizures. The study will include up to 8 sites in Australia and randomized approximately 35 patients. Depending on the rate of enrollment, top line data could be available in the first half of 2024.

繼續進行管道。我們將於今年 4 月與 FDA 就重新提交 SPN-830（我們的阿撲嗎啡輸注設備）的 NDA 會面。我們將在與 FDA 討論後宣布重新提交的時間。我們在難治性癲癇發作的成年患者中啟動了 SPN-817 的開放標籤 II 期臨床研究。該研究將包括澳大利亞多達 8 個地點，並隨機抽取大約 35 名患者。根據入學率，頂線數據可能會在 2024 年上半年提供。

For SPN-820, our first-in-class orally active mTORC1 activator, the Phase II multicenter randomized double-blind placebo-controlled study in adults with treatment-resistant depression is ongoing with 25 sites activated. The study will examine the efficacy and safety of 820 over a course of 5 weeks of treatment in approximately 270 patients. The primary outcome measure is the change from baseline to end of treatment period on the Montgomery-Asberg Depression Rating Scale Total Score, which is a standard depression rating scale.

對於 SPN-820，我們一流的口服活性 mTORC1 激活劑，II 期多中心隨機雙盲安慰劑對照研究正在對難治性抑鬱症成人患者進行，有 25 個點被激活。該研究將在大約 270 名患者的 5 周治療過程中檢查 820 的療效和安全性。主要結果指標是蒙哥馬利-阿斯伯格抑鬱量表總分從基線到治療期結束的變化，這是一種標準的抑鬱量表。

Finally, we continue to be active in corporate development, looking for strategic opportunities to further strengthen our future growth and leadership position in CNS. In summary, we are confident that our growth drivers and solid foundation will allow us to offset the impact coming from the loss of exclusivity of Trokendi XR and allow us to return to revenue and non-GAAP operating income growth in 2024 and beyond.

最後，我們繼續積極參與企業發展，尋找戰略機遇，進一步加強我們在 CNS 的未來發展和領導地位。總之，我們有信心，我們的增長動力和堅實的基礎將使我們能夠抵消失去 Trokendi XR 獨家經營權所帶來的影響，並使我們能夠在 2024 年及以後恢復收入和非 GAAP 營業收入增長。

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

有了這個，我現在將把電話轉給蒂姆。

Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2022 results, please refer to today's press release. Total revenue for the fourth quarter 2022 was $167.3 million, a 5% increase compared to $159.1 million in the same quarter last year. Total revenue in the fourth quarter of 2022 was comprised of net product sales of $163.8 million and royalty revenue of $3.5 million. The increase was primarily due to growth in net product sales of GOCOVRI and Qelbree.

謝謝你，傑克。大家下午好。在我回顧我們的第四季度和 2022 年全年業績時，請參閱今天的新聞稿。 2022 年第四季度的總收入為 1.673 億美元，比去年同期的 1.591 億美元增長 5%。 2022 年第四季度的總收入包括 1.638 億美元的產品淨銷售額和 350 萬美元的特許權使用費收入。增長主要是由於 GOCOVRI 和 Qelbree 的產品淨銷售額增長。

For the fourth quarter of 2022, combined R&D and SG&A expenses were $91.7 million as compared to $122.8 million for the same period last year. The decrease was primarily due to expenses associated with the Adamas acquisition which occurred in Q4 of 2021. Amortization of intangible assets for the fourth quarter 2022 were $20.7 million compared to $12 million for the same period last year. The increase is due to the Adamas acquisition, which again occurred in November of 2021.

2022 年第四季度，研發和 SG&A 費用合計為 9170 萬美元，而去年同期為 1.228 億美元。減少的主要原因是與 2021 年第四季度發生的 Adamas 收購相關的費用。2022 年第四季度的無形資產攤銷為 2070 萬美元，而去年同期為 1200 萬美元。增加是由於 Adamas 的收購，這再次發生在 2021 年 11 月。

Operating earnings on a GAAP basis for the fourth quarter of 2022 was $34.3 million as compared to operating earnings of $6.1 million for the same period last year. The increase in GAAP operating earnings is primarily attributable to an increase in net product sales in Q4 2022 and lower expenses due to costs associated with the Adamus acquisition, which occurred in Q4 of 2021. Tax expense for the fourth quarter 2022 was $9.4 million as compared to an income tax benefit of $391,000 for the same period last year. GAAP net earnings were $25.5 million for the fourth quarter of 2022 or $0.43 per diluted share compared to $2.4 million or $0.04 per diluted share in the same period last year.

2022 年第四季度按 GAAP 計算的營業收入為 3430 萬美元，而去年同期的營業收入為 610 萬美元。 GAAP 營業收入的增加主要歸因於 2022 年第四季度產品淨銷售額的增加以及與 2021 年第四季度發生的 Adamus 收購相關的成本導致的費用減少。與去年同期相比，2022 年第四季度的稅收費用為 940 萬美元去年同期的所得稅收益為 391,000 美元。 2022 年第四季度的 GAAP 淨收益為 2550 萬美元或攤薄後每股收益 0.43 美元，而去年同期為 240 萬美元或攤薄後每股收益 0.04 美元。

On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration, acquisition-related costs and depreciation, adjusted operating earnings were $57.6 million compared to $46.2 million in the same period last year. Total revenue for the full year 2022 was $667.2 million, a 15% increase compared to $579.8 million for the full year 2021. Total revenue was comprised of net product sales of $649.4 million and royalty revenue of $17.8 million. The increase was primarily due to the growth in net product sales of GOCOVRI as well as Qelbree.

在不包括無形資產攤銷、股份補償、或有對價、收購相關成本和折舊的非美國通用會計準則基礎上，調整後營業利潤為 5760 萬美元，而去年同期為 4620 萬美元。 2022 年全年總收入為 6.672 億美元，比 2021 年全年的 5.798 億美元增長 15%。總收入包括 6.494 億美元的產品淨銷售額和 1780 萬美元的特許權使用費收入。這一增長主要是由於 GOCOVRI 和 Qelbree 產品淨銷售額的增長。

For the full year 2022, combined R&D and SGA expenses were $451.8 million as compared to $395.2 million for the full year 2021. The increase in expenses is primarily due to activities to support the launch of Qelbree, including the investment in the DTC campaign and cost to support the growth of GOCOVRI. Amortization of intangible assets for the full year of 2022 was $82.6 million compared to $30 million for the full year 2021. The increase is due to the Adamus acquisition.

2022 年全年，研發和 SGA 支出合計為 4.518 億美元，而 2021 年全年為 3.952 億美元。支出增加主要是由於支持 Qelbree 上市的活動，包括對 DTC 活動的投資和成本支持 GOCOVRI 的發展。 2022 年全年無形資產攤銷為 8260 萬美元，而 2021 年全年為 3000 萬美元。增加的原因是對 Adamus 的收購。

Operating expenses on a GAAP basis for the full year 2022 was $46.1 million as compared to $86 million for the full year 2021. The decrease in GAAP operating earnings is primarily attributable to higher expenses to support the launch of Qelbree, the DTC campaign and the amortization of intangibles associated with the Adamas acquisition. Other income for the full year 2022 was $14.6 million as compared to $12.9 million of expense for the full year 2021. The change is primarily due to a gain recognized on the sale of a subsidiary of Navitor and a decrease in the interest expense due to the adoption of the new accounting standard in the first quarter of 2022.

2022 年全年按 GAAP 計算的運營費用為 4610 萬美元，而 2021 年全年為 8600 萬美元。GAAP 運營收益的減少主要是由於支持 Qelbree 推出、DTC 活動和攤銷的費用增加與 Adamas 收購相關的無形資產。 2022 年全年的其他收入為 1,460 萬美元，而 2021 年全年的支出為 1,290 萬美元。這一變化主要是由於出售 Navitor 子公司時確認的收益以及利息支出減少所致2022 年第一季度採用新會計準則。

Full year 2022 income tax expense was $32,000 as compared to $19.8 million for the full year 2021. As previously discussed on prior calls, the low tax expense for the full year 2022 was due to a corporate reorganization of the Adamas entities in the first quarter of 2022. GAAP net earnings was $60.7 million for the full year 2022 or $1.04 per diluted share compared to $53.4 million or $0.98 per diluted share for the full year 2021. On a non-GAAP basis, which excludes amortization of intangibles, share-based compensation, contingent consideration, acquisition-related costs, other R&D and depreciation, adjusted operating earnings for the full year 2022 was $148.8 million as compared to $167.3 million for the full year 2021.

2022 年全年的所得稅費用為 32,000 美元，而 2021 年全年的所得稅費用為 1,980 萬美元。正如之前在電話會議上討論的那樣，2022 年全年的低稅收費用是由於 Adamas 實體在第一季度的企業重組2022 年 2022 年全年 GAAP 淨收益為 6070 萬美元或攤薄後每股收益 1.04 美元，而 2021 年全年淨收益為 5340 萬美元或攤薄後每股收益 0.98 美元。在非 GAAP 基礎上，不包括無形資產攤銷、股權補償、或有對價、收購相關成本、其他研發和折舊、調整後的 2022 年全年營業收入為 1.488 億美元，而 2021 年全年為 1.673 億美元。

As of December 31, 2022, the company had approximately $555.2 million in cash, cash equivalents and marketable securities compared to $458.8 million as of December 31, 2021. The increase is primarily due to cash generated from operations. Earlier this month, we entered into a credit line agreement that enhances the strength and flexibility of our balance sheet. This credit line provides for a revolving line of credit of up to $150 million, which can be drawn at any time for a period of 1 year, which includes renewal options.

截至 2022 年 12 月 31 日，公司擁有約 5.552 億美元的現金、現金等價物和有價證券，而截至 2021 年 12 月 31 日為 4.588 億美元。增加的主要原因是運營產生的現金。本月早些時候，我們簽訂了一項信貸額度協議，增強了我們資產負債表的實力和靈活性。該信用額度提供高達 1.5 億美元的循環信用額度，可隨時提取，期限為 1 年，其中包括續簽選項。

Now turning to guidance. We expect total revenue to range from $580 million to $620 million, comprised of net product sales and royalty revenue. Please note, total revenue guidance for 2023 assumes approximately $60 million to $80 million of net product sales of Trokendi XR, as Jack mentioned earlier. We are providing Trokendi XR specific net product sales guidance to provide more insight on the base business as the Trokendi erosion is uncertain at this point. Full year 2023 total revenue guidance, excluding net product sales of Trokendi XR represents an approximate 30% growth rate. For the full year 2023, we expect combined R&D and SG&A expenses to range from $460 million to $490 million.

現在轉向指導。我們預計總收入在 5.8 億美元至 6.2 億美元之間，包括淨產品銷售額和特許權使用費收入。請注意，正如傑克之前提到的，2023 年的總收入指引假設 Trokendi XR 的產品淨銷售額約為 6000 萬至 8000 萬美元。我們正在提供 Trokendi XR 特定的淨產品銷售指導，以提供更多關於基礎業務的見解，因為此時 Trokendi 侵蝕還不確定。 2023 年全年總收入指引，不包括 Trokendi XR 的產品淨銷售額，增長率約為 30%。對於 2023 年全年，我們預計研發和 SG&A 的合併支出將在 4.6 億美元至 4.9 億美元之間。

Overall, we expect full year 2023 GAAP operating loss in the range of $25 million to $50 million. And finally, we expect non-GAAP operating earnings to range from $65 million to $95 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.

總體而言，我們預計 2023 年全年 GAAP 運營虧損將在 2500 萬至 5000 萬美元之間。最後，我們預計非 GAAP 營業收入將在 6500 萬美元至 9500 萬美元之間。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 之間調節項目的各種範圍。

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

有了這個，我現在將把電話轉回接線員進行問答。克里斯？

(Operator Instructions) Our first question will come from David Amsellem of Piper Sandler.

（操作員說明）我們的第一個問題將來自 Piper Sandler 的 David Amsellem。

Just a couple. So on the PBM win for Qelbree, can you confirm that it's ESI? And just talk about what additional payer execution you need to deliver on or looking to deliver on as the year progresses and longer term? That's number one. Number two is, can you talk about Qelbree cadence for the year? I know you're not giving product-specific guidance on Qelbree. Can you talk about the extent to which we're going to see a sequential step down in sales in 1Q? And is it safe to assume that a lot of sales will be back half of the year loaded just because of the back-to-school season? How should we think about that?

只是一對。那麼關於 Qelbree 的 PBM 勝利，你能確認它是 ESI 嗎？並且只是談談隨著時間的推移和更長期的發展，您需要交付或希望交付哪些額外的付款人執行？這是第一。第二，你能談談今年的 Qelbree 節奏嗎？我知道您沒有提供有關 Qelbree 的產品特定指導。你能談談我們將在多大程度上看到第一季度的銷售額連續下降？並且可以安全地假設很多銷售會因為返校季節而在今年下半年加載嗎？我們應該如何考慮？

Yes. Regarding the first question of PBM, yes, it is ESI. And we got a really good position on the formulary. Do we have any more to work on? Absolutely. I mean that's always work in progress as far as continued workload to improve the coverage across board, not just on the commercial side, but also Medicaid, working with different states. And pretty much, you always have the cycles of renewals with pretty much everybody. So clearly, all that together is aligned to get us to the 50% to 55% target that we set out for ourselves. But certainly, the new contract will make a major headway towards that goal. If you remember, we ended the year somewhere around the 61% gross to net. So we're not too far away from the 55 or 50. Clearly, the new contract will help us in a big significant step towards that goal.

是的。關於PBM的第一個問題，沒錯，就是ESI。我們在處方集上佔據了非常好的位置。我們還有什麼要做的嗎？絕對地。我的意思是，就持續的工作量而言，這一直在進行中，以提高全面的覆蓋範圍，不僅在商業方面，而且在醫療補助方面，與不同的州合作。幾乎每個人都有續約的周期。很明顯，所有這些加在一起是為了讓我們達到我們為自己設定的 50% 到 55% 的目標。但可以肯定的是，新合同將在實現這一目標方面取得重大進展。如果你還記得的話，我們在今年年底的毛淨利潤率大約為 61%。所以我們距離 55 或 50 並不太遠。顯然，新合同將幫助我們朝著這個目標邁出重要的一大步。

And absolutely, for 2023, I mean, given the guidance we gave and taking Trokendi XR out of it, you can make fairly close assumptions to what the other pieces are and get to where the Qelbree number is within that guidance. We certainly, as I mentioned in my remarks, we are expecting a very solid year from Qelbree in 2023. We're very excited about all the growth metrics that we've seen and that we exited with in 2022. So we think that the brand is very much well in place and positioned to give us a very strong year in 2023. And certainly, the back-to-school season will always be a big part of that, absolutely.

當然，對於 2023 年，我的意思是，根據我們給出的指導並從中取出 Trokendi XR，您可以對其他部分做出相當接近的假設，並得出 Qelbree 數字在該指導範圍內的位置。正如我在發言中提到的，我們當然期待 Qelbree 在 2023 年取得非常穩健的一年。我們對我們已經看到並在 2022 年退出的所有增長指標感到非常興奮。因此我們認為品牌非常到位，並有能力在 2023 年為我們帶來非常強勁的一年。當然，返校季將永遠是其中的重要組成部分，絕對如此。

Our next question will come from Andrew Tsai of Jefferies.

我們的下一個問題將來自 Jefferies 的 Andrew Tsai。

Congrats on a great quarter. I guess I'll start off with a bigger picture question. You kind of alluded it throughout your prepared remarks and the initial Q&A. But is it fair to classify Qelbree as still in the early innings of launch? And then secondly, as we think about 2023, what would you say are the key drivers to volume growth as well as price. I mean it sounds like you have locked in some nice contracts as well. But the real of the question is, in your view, if you were to rank order perhaps, how do we get more sales in the next few quarters and even possibly an acceleration of sales?

祝賀一個偉大的季度。我想我將從一個更大的問題開始。你在準備好的發言和最初的問答中都提到了它。但是，將 Qelbree 歸類為仍處於發布的早期階段是否公平？其次，當我們考慮到 2023 年時，您認為推動銷量和價格增長的主要因素是什麼。我的意思是聽起來你也鎖定了一些不錯的合同。但真正的問題是，在你看來，如果你要排序，我們如何在接下來的幾個季度獲得更多的銷售，甚至可能加速銷售？

Yes, sure. There is no question, I mean Qelbree is still in the early innings of the launch. I mean, we're not even 1 year into the launch of the adult indication. In the adult segment, if you recall, is about 67% of the market. So we are only at the beginning of that launch, and we haven't much scratched the surface as far as the growth potential. As I mentioned earlier, the market, interestingly, in a great way, obviously, continues to grow significantly and much more than we ever expected. I mean it grew in '21, 8.5%. And then on top of that, another 9% in 2022. So the market in itself is growing, reaching now already 90 million prescriptions.

是的，當然。毫無疑問，我的意思是 Qelbree 仍處於發布的早期階段。我的意思是，我們推出成人適應症還不到 1 年。如果您還記得，在成人市場中，大約佔市場的 67%。因此，我們才剛剛開始發布，就增長潛力而言，我們還沒有觸及表面。正如我之前提到的，有趣的是，市場顯然以一種很好的方式繼續顯著增長，而且比我們預期的要多得多。我的意思是它在 21 年增長了 8.5%。最重要的是，到 2022 年再增長 9%。因此，市場本身也在增長，現在已經達到 9000 萬張處方。

Clearly, our 320,000 some prescriptions last year is only scratching the surface as far as penetration into that market. So we continue to have high expectations for the product and its growth potential as time goes on. As far as the drivers for 2023, as I mentioned earlier, I mean, some of the key factors are, for example, the continued penetration from a prescription perspective, the size of prescription is going up because of the daily doses also going up, especially as we penetrate further into the adult segment because the average daily dose there could be as close to the 500 on the pediatric side; adolescent side, closer to the 300, 400-milligram level. And then you combine that clearly with the sales force expansion and deeper penetration and coverage of the ADHD market. We still have a lot of physicians in our call on universe that haven't really started even prescribing.

顯然，就滲透到該市場而言，我們去年的 320,000 份處方只是觸及表面。因此，隨著時間的推移，我們繼續對該產品及其增長潛力抱有很高的期望。至於 2023 年的驅動因素，正如我之前提到的，我的意思是，一些關鍵因素是，例如，從處方的角度來看，處方的持續滲透，由於每日劑量也在增加，處方的規模也在增加，特別是當我們進一步深入成人市場時，因為那裡的平均日劑量可能接近兒科方面的 500；青春期方面，接近300、400毫克的水平。然後你將其與銷售隊伍的擴張以及對 ADHD 市場的更深入滲透和覆蓋清楚地結合起來。在我們對 Universe 的呼籲中，我們仍然有很多醫生甚至還沒有真正開始開處方。

So we have a lot of potential out there for us to start turning a lot of these physicians, let them try the product, let them get the experience with it. Because actually, once these physicians try the product and get some experience with it and we have this information from our running survey among prescribers, there is a level of satisfaction that is truly incredible, about 90% satisfaction level among physicians who use Qelbree. And that actually compares to about 51% for Strattera interestingly by these same physicians who have used Strattera for years.

所以我們有很大的潛力讓我們開始轉變這些醫生，讓他們嘗試產品，讓他們獲得使用它的經驗。因為實際上，一旦這些醫生嘗試了該產品並獲得了一些使用經驗，並且我們從對開處方者的持續調查中獲得了這些信息，就會有一個真正令人難以置信的滿意度，使用 Qelbree 的醫生的滿意度約為 90%。實際上，有趣的是，這些使用 Strattera 多年的醫生對 Strattera 的支持率約為 51%。

So it really shows you that once they try Qelbree, the experience there typically is positive. And clearly, that will encourage them to have a much wider penetration within their practice as far as putting more patients on Qelbree. So all these factors combined, and then in the end, the gross to net improvement and so forth should certainly deliver a very robust growth in net sales.

所以它真的向你表明，一旦他們嘗試了 Qelbree，那裡的體驗通常是積極的。顯然，這將鼓勵他們在實踐中有更廣泛的滲透，讓更多患者接受 Qelbree。因此，所有這些因素結合在一起，最後，毛淨改善等等肯定會帶來非常強勁的淨銷售額增長。

Great. And so speaking of the expansion of sales force, your current guidance of OpEx, I think $460 million to $490 million, it's incrementally a little bit up versus $450 million, I believe, in 2022. So does your 2023 guidance incorporate a new DTC launch? Or is it primarily driven by the sales force assumption and expansion. And assuming there is a new DTC launch, then the question would be, do you think 2023 OpEx could be kind of, pardon my choice of words, maybe the peak expense year for the, let's just say, short to medium term, the next 2 to 3 years? Or is that not necessarily the case?

偉大的。因此，談到銷售人員的擴張，您目前對運營支出的指導，我認為是 4.6 億至 4.9 億美元，與 2022 年的 4.5 億美元相比略有增加。您的 2023 年指導是否包含新的 DTC 發布？或者它主要是由銷售人員假設和擴張驅動的。假設有一個新的 DTC 發布，那麼問題是，你認為 2023 年的 OpEx 可能是，請原諒我的措辭，也許是下一個短期到中期的支出高峰年2到3年？還是不一定如此？

Yes. Regarding the commercial side, so sales force and marketing and the heavy investment that we put in behind Qelbree, obviously, in 2021 and 2022, we will continue with that in 2023. I'm not going to be able to be too specific on DTC and how much and whether because some of these decisions are in progress, and it's a fluid, at this point, process for us. But basically, we will continue the strong support behind Qelbree and GOCOVRI clearly.

是的。關於商業方面，銷售人員和營銷以及我們在 Qelbree 背後投入的大量投資，顯然，在 2021 年和 2022 年，我們將在 2023 年繼續這樣做。我不能在 DTC 上太具體以及多少以及是否因為其中一些決定正在進行中，並且在這一點上，它對我們來說是一個流動的過程。但基本上，我們將繼續明確支持 Qelbree 和 GOCOVRI。

On the sales force, the expansion partial -- part of that cost is going to be covered by the fact that we don't have a third sales force anymore that we used to have in 2022, because as you recall, we have stopped the in-person sales effort behind Trokendi XR and Oxtellar XR. So that sales support and the costs associated with that sales support will not continue into 2023, but some of it will go towards the coverage of the expansion in the Qelbree sales force. But another main component in that $460 million to $490 million is R&D. R&D, if you look at 2022 was much lower than 2021.

在銷售人員方面，部分擴張——部分成本將由我們不再擁有 2022 年以前擁有的第三名銷售人員這一事實來支付，因為正如你記得的那樣，我們已經停止了Trokendi XR 和 Oxtellar XR 背後的現場銷售工作。因此，銷售支持和與銷售支持相關的成本將不會持續到 2023 年，但其中一部分將用於覆蓋 Qelbree 銷售人員的擴張。但在這 4.6 億至 4.9 億美元中，另一個主要部分是研發。研發，如果你看一下 2022 年比 2021 年要低得多。

We do expect in 2023, and hopefully, we're correct that enrollment will speed up on SPN-820, SPN-817, spending is going to start to increase as we start all these trials. So we expect a bump in R&D that is part of the increase that you see from the $450 million in 2022 going up to the $460 million to $490 million in 2023. So that's another big component there as well.

我們確實預計在 2023 年，並且希望我們是正確的，即 SPN-820、SPN-817 的註冊將加快，隨著我們開始所有這些試驗，支出將開始增加。因此，我們預計研發會有所增加，這是您看到的增長的一部分，從 2022 年的 4.5 億美元增加到 2023 年的 4.6 億美元至 4.9 億美元。所以這也是另一個重要組成部分。

Makes sense. And then maybe the last question is I guess we can ask on the 2023 revenue guide, if we take out Trokendi, maybe it's around $520 million to $540 million, what would be the assumptions at the lower end, higher end? And it's a pretty tight range. It seems like you do have visibility. But I guess also the root of the question is, do you think your initial guidance is provided in such a way that you could potentially raise your guidance throughout the year?

說得通。然後也許最後一個問題是我想我們可以問 2023 年收入指南，如果我們去掉 Trokendi，它可能在 5.2 億美元到 5.4 億美元左右，低端、高端的假設是什麼？這是一個非常狹窄的範圍。看來你確實有知名度。但我想問題的根源還在於，您是否認為提供初始指導的方式可以讓您全年提高指導？

I mean, in general, as a principle, and we like to provide a guidance that is our best guess at this time with the information that we have in providing the guidance for 2023. So our goal is always to do it in a reasonable way. That is, of course, achievable. We don't like to miss guidance, but also we don't like to be too conservative either. So you have to really be in a reasonable band providing the guidance.

我的意思是，總的來說，作為一項原則，我們希望根據我們在提供 2023 年指南時所掌握的信息，提供目前我們最好的猜測。因此，我們的目標始終是以合理的方式進行.那當然是可以實現的。我們不喜歡錯過指導，但我們也不喜歡過於保守。所以你必須真正處於提供指導的合理範圍內。

So to your question, when you back out Trokendi XR and you look at the remaining pieces, Oxtellar XR, APOKYN, GOCOVRI, for example, continue to be a growth product for us, and we're happy with the growth that it delivered. And then you look at the other 3 products, I think you can get to a reasonable range on what Qelbree really is and how much Qelbree is as far as part of that guidance. So we feel pretty comfortable with the ranges around the different pieces. And for the same reasons I mentioned today about Qelbree and how we're very excited about its potential, the momentum the product has had, a great start in 2023 so far. And we're pretty happy with the different metrics that I talked about.

所以對於你的問題，當你退出 Trokendi XR 並查看剩餘的部分時，例如 Oxtellar XR、APOKYN、GOCOVRI 繼續成為我們的增長產品，我們對它帶來的增長感到滿意。然後你看看其他 3 種產品，我認為你可以在一個合理的範圍內了解 Qelbree 的真正含義以及 Qelbree 在該指南中的含量。所以我們對不同部分的範圍感到很舒服。出於我今天提到的關於 Qelbree 的同樣原因，以及我們對它的潛力、產品所擁有的勢頭以及 2023 年迄今為止的良好開端感到非常興奮。我們對我談到的不同指標感到非常滿意。

So all in all, we think this guidance should be achievable. But only time will tell, and we'll update you as time goes on.

所以總而言之，我們認為這個指導應該是可以實現的。但只有時間會證明一切，我們會隨著時間的推移向您更新。

(Operator Instructions) Our next question will come from Annabel Samimy of Stifel.

（操作員說明）我們的下一個問題將來自 Stifel 的 Annabel Samimy。

This is Jack on for Annabel. So 2 for us. First, regarding the patients on Qelbree, do you have any additional clarity on how many of those patients are newly diagnosed versus coming from stimulants? And have you noticed any differences between pediatric adult patients in terms of willingness to begin treatment with a nonstimulant compared to transitioning from a prior stimulant? And second, for some additional granularity on the GOCOVRI efforts. Growth has been decent so far, but do you have an idea on how much of this growth is a result from your improved messaging about the dual profile versus improved payer access? And what specifically is resonating most with physicians?

這是安娜貝爾的傑克。所以 2 對我們來說。首先，關於服用 Qelbree 的患者，您是否更清楚這些患者中有多少是新診斷的，而不是來自興奮劑？您是否注意到與從先前的興奮劑過渡相比，兒科成年患者在開始使用非興奮劑治療的意願方面有任何差異？其次，對於 GOCOVRI 工作的一些額外粒度。到目前為止，增長一直不錯，但您是否知道這種增長有多少是由於您改進了關於雙重資料的消息傳遞與改進的付款人訪問？什麼最能引起醫生的共鳴？

Yes, starting with Qelbree as far as the source of the business or where are these patients primarily coming from, when we ask current prescribers of Qelbree, and we talk about that, I referenced that a little bit last year in a couple of quarters. Most of the patients in the top 4 reasons for why physicians are putting patients on the product is that these are patients who have issues with stimulants.

是的，從 Qelbree 開始，就業務來源或這些患者主要來自哪裡，當我們詢問 Qelbree 的當前處方者並討論這一點時，我去年在幾個季度中提到了一點。在醫生讓患者服用該產品的前 4 大原因中，大多數患者是因為這些患者對興奮劑有問題。

And we mentioned that, that actually is very reassuring for us because we wanted Qelbree to be seen as an alternative, not just to other nonstimulants but actually an alternative for all patients in ADHD. And primarily those in the stimulant category because we know for a fact a lot of patients are out there are on the stimulants and they don't need to be on stimulants or they don't have to be on stimulants and put up with all the issues that stimulants bring as far as tolerability and safety and abuse of controlled substances and so forth. So it's been very reassuring for us to continue to get that feedback from our prescribers that the main source of the business is from stimulants, especially with those who have experienced side effects and so forth.

我們提到，這實際上讓我們感到非常安心，因為我們希望 Qelbree 被視為一種替代品，不僅是其他非興奮劑的替代品，而且實際上是所有 ADHD 患者的替代品。主要是那些在興奮劑類別中的人，因為我們知道事實上很多患者都在服用興奮劑，他們不需要服用興奮劑，或者他們不必服用興奮劑並忍受所有興奮劑帶來的耐受性和安全性以及受控物質的濫用等問題。因此，我們非常放心地繼續從我們的處方者那裡得到反饋，即業務的主要來源來自興奮劑，尤其是那些經歷過副作用等的人。

I'll give you an example. I mean, about 15% are from stimulants who have major AEs, experiencing major side effects, another 15% who've tried stimulants, but just don't work. I mean, what people forget also, for a lot of clients, the stimulants don't work for everybody as well, not everybody responds to stimulant. And then there is a good portion, which is in the mid-teens, which is completely new patients and we would expect that obviously to grow over time. But in general, we're pretty happy with the mix of patients and the source of business, especially early in the launch because that tells us that in the physicians' minds, Qelbree is an option to all patients. It's not just an option as a second-line treatment in nonstimulant category.

我給你舉個例子。我的意思是，大約 15% 的人來自興奮劑，他們有主要的 AE，經歷過主要的副作用，另外 15% 的人嘗試過興奮劑，但就是不管用。我的意思是，人們也忘記了，對於很多客戶來說，興奮劑並不對每個人都有效，並不是每個人都對興奮劑有反應。然後有很大一部分，在十幾歲的中期，這是全新的患者，我們預計隨著時間的推移，這顯然會增加。但總的來說，我們對患者和業務來源的組合非常滿意，尤其是在發布初期，因為這告訴我們，在醫生看來，Qelbree 是所有患者的選擇。它不僅僅是作為非興奮劑類二線治療的一種選擇。

And as far as the GOCOVRI growth is concerned, most of the growth is coming because of the positioning, the message and really the effort that our sales force is putting out there. So we've been able to have a very clear positioning about the product and its uniqueness in the Parkinson's area. It's a very crowded space. Pretty much every product treats off episodes, but only GOCOVRI treat off episodes and deals with dyskinesia. And that is a clear message that is out in the marketplace that we are pushing and educating physicians around the fact that they can actually treat both, dyskinesia and off episodes with GOCOVRI, instead of all the other agents they use that not only treat off episodes but some of them actually like levodopa, carbidopa cause dyskinesia. So clearly, GOCOVRI is -- that message is resonating, and that's what's resulting in what is a healthy growth on the prescription side.

就 GOCOVRI 的增長而言，大部分增長都是由於定位、信息以及我們的銷售人員在那裡付出的努力。因此，我們已經能夠對該產品及其在帕金森領域的獨特性有一個非常明確的定位。這是一個非常擁擠的空間。幾乎所有產品都能治療發作，但只有 GOCOVRI 能治療發作和運動障礙。這是市場上的一個明確信息，即我們正在推動和教育醫生，他們實際上可以用 GOCOVRI 治療運動障礙和發作，而不是他們使用的所有其他藥物，這些藥物不僅可以治療發作但其中一些實際上像左旋多巴、卡比多巴一樣引起異動症。很明顯， GOCOVRI 是——這個信息引起了共鳴，這就是導致處方方面健康增長的原因。

(Operator Instructions) I am seeing no further questions in the queue. I would now like to turn the conference back to Jack Khattar for closing remarks.

（操作員說明）隊列中沒有其他問題。我現在想把會議轉回 Jack Khattar 作閉幕詞。

Thank you. In concluding our call this afternoon, I would like to emphasize that delivering strong growth in our business remains our top priority. As we mentioned earlier, excluding Trokendi XR, our business is expected to deliver growth rate of approximately 30% in revenues in 2023. I would like to thank all our employees for delivering another outstanding year with record revenues for Supernus and for positioning us well with solid momentum behind both Qelbree and GOCOVRI. We look forward to return to double-digit growth in revenues and delivering healthy operating margins that preceded our transition years. Thanks for joining us this afternoon, and we look forward to updating everyone on our next call.

謝謝。在結束今天下午的電話會議時，我想強調，實現我們業務的強勁增長仍然是我們的首要任務。正如我們之前提到的，不包括 Trokendi XR，我們的業務預計將在 2023 年實現約 30% 的收入增長率。我要感謝我們所有的員工為 Supernus 帶來了又一個出色的年度，創紀錄的收入，並使我們在Qelbree 和 GOCOVRI 背後的強勁勢頭。我們期待收入恢復兩位數增長，並實現過渡期之前的健康運營利潤率。感謝您今天下午加入我們，我們期待在下次電話會議上為大家提供最新消息。

This concludes today's conference call. Thank you all for participating. You may now disconnect, and have a pleasant day.

今天的電話會議到此結束。謝謝大家的參與。您現在可以斷開連接，並度過愉快的一天。