Collegium Pharmaceutical Inc (COLL) 2024 Q1 法說會逐字稿

Greetings, and welcome to the Collegium Pharmaceutical first-quarter 2024 earnings conference. (Operator Instructions)

您好，歡迎參加 Collegium Pharmaceutical 2024 年第一季財報會議。（操作員說明）

Please note that this conference call is being recorded. I will now turn the call over to Christopher James, Vice President of Investor Relations at Collegium. Thank you. You may begin.

請注意，本次電話會議正在錄音中。我現在將把電話轉給 Collegium 投資者關係副總裁 Christopher James。謝謝。你可以開始了。

Welcome to Collegium Pharmaceutical's first-quarter 2024 earnings conference call. I'm joined today by Joe Ciaffoni, our Chief Executive Officer; Colleen Tupper, our Chief Financial Officer, and Scott Dreyer, our Chief Commercial Officer. Mike Heffernan, the Chairman of our Board, will join us for the Q&A portion of the call.

歡迎參加 Collegium Pharmaceutical 2024 年第一季財報電話會議。今天我們的執行長 Joe Ciaffoni 也加入了我的行列。我們的財務長科琳‧塔珀 (Colleen Tupper) 和我們的商務長 Scott Dreyer。我們的董事會主席 Mike Heffernan 將參加我們電話會議的問答部分。

Before we begin today's call, we want to remind participants that none of the information presented today is intended to be promotional and that any forward-looking statements made today are made pursuant to the Safe Harbor provision of the Private Securities Litigation Reform Act of 1995.

在我們開始今天的電話會議之前，我們想提醒與會者，今天提供的任何資訊都無意進行促銷，並且今天所做的任何前瞻性陳述都是根據1995 年《私人證券訴訟改革法案》的安全港條款做出的。

You are cautioned that such forward-looking statements involve risks and uncertainties, including and without limitation, the risks that we may not be able to successfully commercialize our products, that we may incur significant expense in doing so and that we may not prevail in current or future litigation pertaining to our business. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission.

請注意，此類前瞻性聲明涉及風險和不確定性，包括但不限於我們可能無法成功將我們的產品商業化的風險，我們可能會為此承擔巨額費用，以及我們可能無法在當前的情況下獲勝。本公司的這些風險和其他風險在公司向美國證券交易委員會提交的定期報告中有詳細說明。

Our future results may differ materially from our current expectations discussed today. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-GAAP reconciliations, on our corporate website at collegiumpharma.com.

我們未來的結果可能與我們今天討論的當前預期有重大差異。我們的收益新聞稿和本次電話會議將包括對某些非公認會計準則資訊的討論。您可以在我們的公司網站 collegiumpharma.com 上找到我們的收益新聞稿，包括相關的非 GAAP 調整表。

I will now turn the call over to our CEO, Joe Ciaffoni.

我現在將把電話轉給我們的執行長 Joe Ciaffoni。

Thank you, Chris. Good afternoon, and thank you, everyone, for joining the call. Today, we will discuss our financial performance during the first quarter and provide an update on our progress in 2024. At Collegium, we are focused on building a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. We strive to do good as we do well.

謝謝你，克里斯。下午好，謝謝大家加入通話。今天，我們將討論第一季的財務業績，並提供 2024 年進展的最新資訊。在 Collegium，我們致力於建立一家領先的多元化專業製藥公司，致力於改善患有嚴重疾病的人們的生活。我們努力做好事，做好事。

During the first quarter, in support of our commitment to increase equitable access to STEM education and advance the next generation of life science leaders, we selected the first participants in the Collegium Pharmaceutical Scholarship Program. This new program awards two scholarships to high school seniors pursuing a STEM-related major at a US university.

在第一季度，為了支持我們增加公平獲得 STEM 教育的機會並培養下一代生命科學領導者的承諾，我們選擇了 Collegium Pharmaceutical 獎學金計劃的第一批參與者。這項新計畫向在美國大學攻讀 STEM 相關專業的高中生頒發兩項獎學金。

Additionally, at our 2024 National Sales Meeting, we built wagons filled with toys for Nicklaus Children's Hospital in Miami, and we began the second year of our partnership with the Boston Red Sox and Science from Scientists. I'd like to recognize the Collegium team for their commitment to our mission and dedication to making a positive impact in the communities we serve.

此外，在 2024 年全國銷售會議上，我們為邁阿密的尼克勞斯兒童醫院製造了裝滿玩具的馬車，並開始了與波士頓紅襪隊和科學家科學合作的第二年。我要感謝 Collegium 團隊對我們使命的承諾以及對我們所服務的社區產生積極影響的奉獻精神。

We are encouraged by the strong start to the year. 2024 is on track to be another record year for Collegium as we focus on operational execution to grow our core business and deploying capital to create value for our shareholders.

我們對今年的強勁開局感到鼓舞。 2024 年，Collegium 有望再創紀錄，因為我們專注於營運執行以發展核心業務，並部署資本為股東創造價值。

Looking beyond 2024, key accomplishments across the pain portfolio, including growing momentum for BELBUCA, a successful contracting strategy for Xtampza ER in the recently announced authorized generic agreement for the Nucynta Franchise, meaningfully improve our outlook for 2025 and beyond.

展望 2024 年以後，整個疼痛產品組合的關鍵成就，包括 BELBUCA 的成長勢頭、最近宣布的 Nucynta 特許經營授權通用協議中 Xtampza ER 的成功承包策略，將有意義地改善我們對 2025 年及以後的前景。

I am proud of the success that the Collegium team has achieved over the years. We've delivered consistently strong financial performance with a track record of growing the top and bottom line, executing value-creating acquisitions and being good stewards of capital.

我為 Collegium 團隊多年來的成功感到自豪。我們始終保持強勁的財務業績，在增加收入和利潤、執行創造價值的收購以及成為良好的資本管理者方面擁有良好的記錄。

Collegium has an exceptional company culture with a team committed to making a positive impact on the communities we serve. With a healthy balance sheet, disciplined capital deployment strategy, and strong leadership, the company is well positioned for future growth.

Collegium 擁有卓越的公司文化，其團隊致力於對我們所服務的社區產生積極影響。憑藉健康的資產負債表、嚴格的資本部署策略和強大的領導力，該公司為未來的成長做好了充分的準備。

Earlier today, we announced that I will be stepping down as President and Chief Executive Officer of the company. To ensure a seamless transition, Mike Heffernan will serve as Interim President and CEO until a new CEO is appointed. Mike founded Collegium in 2002, served as President and CEO for over 15 years, and is currently the Chairman of our Board. Given his past leadership at Collegium, he is well suited to lead the company during this transition period.

今天早些時候，我們宣布我將辭去公司總裁兼執行長的職務。為了確保無縫過渡，邁克·赫弗南 (Mike Heffernan) 將擔任臨時總裁兼首席執行官，直至任命新首席執行官。Mike 於 2002 年創立了 Collegium，擔任總裁兼執行長超過 15 年，目前擔任我們的董事會主席。鑑於他過去在 Collegium 的領導能力，他非常適合在這段過渡時期領導公司。

It has been a privilege to work with many talented and dedicated colleagues at Collegium, and I am extremely proud of all that we have accomplished together. Collegium is in a strong position both financially and strategically, and I'm confident that we have the right leadership team in place to advance the business forward.

能夠與 Collegium 的許多才華橫溢、敬業的同事一起工作是我的榮幸，我對我們共同取得的成就感到非常自豪。Collegium 在財務和策略上都處於有利地位，我相信我們擁有合適的領導團隊來推動業務發展。

I will now hand the call over to Colleen to discuss business highlights and financials.

我現在將把電話轉給科琳，討論業務亮點和財務狀況。

Thanks, Joe. Good afternoon, everyone. In the first quarter of 2024, we delivered strong financial results, executed our capital deployment strategy, and improved the outlook for our pain portfolio in 2025 and beyond.

謝謝，喬。大家下午好。2024 年第一季度，我們實現了強勁的財務業績，執行了資本部署策略，並改善了 2025 年及以後疼痛產品組合的前景。

Key accomplishments and highlights in 2024 include: we accelerated momentum for BELBUCA, growing prescriptions 4.2% and revenue 15% in the first quarter compared to the prior-year period. We achieved gross to net for Xtampza ER of 53.6% in the first quarter, reflecting the immediate impact of the successful contract renegotiations completed last year.

2024 年的主要成就和亮點包括：我們加快了 BELBUCA 的發展勢頭，與去年同期相比，第一季的處方量增長了 4.2%，收入增長了 15%。第一季度，我們的 Xtampza ER 毛淨比達到 53.6%，反映出去年成功完成的合約重新談判所產生的直接影響。

We strategically deployed capital and strengthened our balance sheet with the redemption of the remaining $26.4 million of our convertible senior notes due in 2026. Our Board authorized a $35 million accelerated share repurchase program, reinforcing our commitment to leveraging our $150 million share repurchase program to return capital to our shareholders.

我們策略性地部署了資本，並透過贖回 2026 年到期的剩餘 2,640 萬美元可轉換優先票據來強化我們的資產負債表。我們的董事會批准了一項 3500 萬美元的加速股票回購計劃，強化了我們利用 1.5 億美元的股票回購計劃向股東返還資本的承諾。

We entered into an agreement with Hikma Pharmaceuticals to distribute authorized generics of Nucynta and Nucynta ER, meaningfully improving our outlook in '25 and beyond. And we presented four scientific posters at the American Academy of Pain Medicine Annual Meeting in March and sponsored a CME program.

我們與 Hikma Pharmaceuticals 簽訂了一項協議，分銷 Nucynta 和 Nucynta ER 的授權仿製藥，這有意義地改善了我們 25 年及以後的前景。我們在 3 月的美國疼痛醫學會年會上展示了四張科學海報，並贊助了 CME 計畫。

Our focus in 2024 is on operational execution. We are on track to deliver record financial performance and deploy capital to rapidly pay down debt and return value to shareholders by opportunistically leveraging our share repurchase program. We delivered record BELBUCA revenue driven by strong prescription growth of 4.2% year over year. We expect BELBUCA revenue growth in 2024 to be fueled by full-year prescription growth.

2024 年我們的重點是營運執行。我們有望實現創紀錄的財務業績，並透過機會主義地利用我們的股票回購計劃部署資本來快速償還債務並為股東回報價值。在處方藥年增 4.2% 的推動下，我們的 BELBUCA 收入創下了紀錄。我們預計 2024 年 BELBUCA 的營收成長將由全年處方成長推動。

Additionally, we expect Xtampza ER revenue growth to be driven by gross to net improvement. The Nucynta Franchise is a key contributor to our pain portfolio. As expected, we saw pressure on Nucynta Franchise revenue in the first quarter due to the elimination of the Medicaid cap by the American Recovery Act. On a full-year basis, we expect some pressure on the Nucynta Franchise year-over-year revenues, with a return to relative year-over-year stability in 2025.

此外，我們預計 Xtampza ER 收入成長將受到毛淨值改善的推動。Nucynta 特許經營權是我們疼痛產品組合的關鍵貢獻者。正如預期的那樣，由於美國復甦法案取消了醫療補助上限，我們看到第一季 Nucynta 特許經營收入面臨壓力。就全年而言，我們預計 Nucynta Franchise 的同比收入將面臨一些壓力，並在 2025 年恢復相對同比穩定。

The 2025 and beyond outlook for our pain portfolio continues to improve. The Medicare Part D redesign will serve as a tailwind for our pain portfolio, in particular for Xtampza ER. The new patient population exclusivity for Nucynta in pediatrics granted in August 2023 was a significant event. We expect to receive a six-month pediatric extension for the Nucynta Franchise in the second half of this year. In addition, we recently selected Hikma Pharmaceuticals to be our authorized generic partner for Nucynta and Nucynta ER, and that agreement further bolsters the value of the franchise.

我們的疼痛產品組合在 2025 年及以後的前景將持續改善。Medicare D 部分的重新設計將成為我們疼痛產品組合的順風車，特別是 Xtampza ER。2023 年 8 月，Nucynta 在兒科領域獲得新的患者群體獨家經營權，這是一個重大事件。我們預計今年下半年 Nucynta 特許經營權將獲得為期六個月的兒科延期。此外，我們最近選擇 Hikma Pharmaceuticals 作為 Nucynta 和 Nucynta ER 的授權仿製藥合作夥伴，該協議進一步增強了特許經營權的價值。

Finally, under the terms of our license of the orange book-listed patents that support the Nucynta Franchise, we expect our royalty obligations to decrease from 14% to 7% in July of 2025 and then to 0% upon the launch of the first authorized generic with Hikma. The competitive landscape relative to BELBUCA has also improved with Chairman's announcement that for the fourth time, the FDA issued a complete response letter for their generic formulation of BELBUCA.

最後，根據我們支持Nucynta 特許經營的橙皮書所列專利的許可條款，我們預計我們的特許權使用費義務將於2025 年7 月從14% 降至7%，然後在推出第一個授權後降至0%與 Hikma 通用。隨著主席宣布 FDA 第四次為其 BELBUCA 仿製藥發出完整的回覆信，BELBUCA 的競爭格局也有所改善。

Following a banner 2023, we further strengthened our financial position in the first quarter of 2024 through record BELBUCA revenue, managed operating expenses, and another quarter of robust cash flows, strengthening our balance sheet.

繼 2023 年的輝煌之後，我們在 2024 年第一季透過創紀錄的 BELBUCA 收入、管理的營運支出以及另一個季度強勁的現金流進一步增強了我們的財務狀況，從而增強了我們的資產負債表。

Financial highlights for the first quarter include: Net product revenues were $144.9 million in the first quarter, relatively flat year over year. BELBUCA net revenue was a record $50.7 million, up 15% year over year. Xtampza ER net revenue was $45.8 million, down 4% year over year, and Xtampza gross to net was 53.6%. As a reminder, gross to net is generally more favorable in the first quarter of each year due to the lower coverage gap expense, also known as the donut hole in Medicare coverage.

第一季的財務亮點包括： 第一季產品淨收入為 1.449 億美元，與去年同期相比相對持平。BELBUCA 淨收入達到創紀錄的 5,070 萬美元，年增 15%。Xtampza ER 淨收入為 4,580 萬美元，年減 4%，Xtampza 總淨收入為 53.6%。提醒一下，由於承保缺口費用（也稱為醫療保險承保中的甜甜圈洞）較低，每年第一季的淨毛比通常更為有利。

As we move through the year, gross to net are expected to be less favorable in the second and third quarters and improve sequentially in the fourth quarter.

隨著今年的進展，預計第二季和第三季的毛淨比將較差，而第四季將較上季改善。

Looking forward to 2025 with the Medicare Part D redesign, this dynamic will change and Xtampza ER will benefit from the phase-in period for small manufacturers. We expect the full-year Xtampza ER gross to net to be between 56% to 58% this year, which is an improvement from 59.6% in 2023.

展望 2025 年，隨著 Medicare D 部分重新設計，這種動態將會改變，Xtampza ER 將受益於小型製造商的分階段實施期。我們預計今年全年 Xtampza ER 總淨收入將在 56% 至 58% 之間，比 2023 年的 59.6% 有所改善。

Nucynta Franchise net revenue was $45.1 million, down 8% year over year. GAAP operating expenses were $42 million, down 20% year over year. And adjusted operating expenses were $34.5 million, down 10% year over year. Net income for the first quarter was $27.7 million compared to a net loss of $17.4 million in the prior-year period.

Nucynta Franchise 淨收入為 4,510 萬美元，年減 8%。GAAP 營運費用為 4,200 萬美元，較去年同期下降 20%。調整後營運費用為 3,450 萬美元，年減 10%。第一季淨利為 2,770 萬美元，而上年同期淨虧損為 1,740 萬美元。

Non-GAAP adjusted EBITDA was $92.4 million, up 5% year over year. GAAP earnings per share was $0.86 basic and $0.71 diluted in the first quarter compared to GAAP loss per share of $0.51 basic and diluted in the prior year period. Non-GAAP adjusted earnings per share was $1.45 in the first quarter, up 10% year over year. Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results.

非 GAAP 調整後 EBITDA 為 9,240 萬美元，較去年同期成長 5%。第一季 GAAP 基本每股收益為 0.86 美元，稀釋後每股收益為 0.71 美元，去年同期 GAAP 基本每股收益和稀釋後每股虧損為 0.51 美元。第一季非 GAAP 調整後每股收益為 1.45 美元，較去年同期成長 10%。請參閱我們今天稍早發布的新聞稿，以了解 GAAP 與非 GAAP 業績的調整。

As of March 31, we had $318 million in cash, cash equivalents, and marketable securities. We generated another quarter of strong cash flows, enabling us to execute on our capital deployment strategy.

截至 3 月 31 日，我們擁有 3.18 億美元的現金、現金等價物和有價證券。我們又創造了一個季度強勁的現金流，使我們能夠執行我們的資本部署策略。

With our strong financial performance in the first quarter, we're reaffirming our 2024 financial guidance. We expect net product revenues in the range of $580 million to $595 million. We expect adjusted operating expenses in the range of $120 million to $125 million, and adjusted EBITDA in the range of $380 million to $395 million.

鑑於第一季強勁的財務業績，我們重申 2024 年的財務指引。我們預計產品淨收入在 5.8 億至 5.95 億美元之間。我們預計調整後的營運費用將在 1.2 億至 1.25 億美元之間，調整後的 EBITDA 將在 3.8 億至 3.95 億美元之間。

We are confident in our ability to deliver on our financial commitments in 2024. Our outlook in 2025 and beyond has improved as well, given the Medicare Part D redesign that will serve as a tailwind to our portfolio, our Nucynta Franchise authorized generic agreement, the anticipated reduction in royalties paid on Nucynta franchise net sales, and the improving competitive landscape for BELBUCA. These positive developments increased the value of our pain portfolio as well as the intrinsic value of our company.

我們對 2024 年履行財務承諾的能力充滿信心。鑑於Medicare D 部分重新設計將成為我們投資組合的推動力、我們的Nucynta 特許經營權授權通用協議、Nucynta 特許經營權淨銷售額支付的特許權使用費預期減少以及競爭性的提高，我們2025 年及以後的前景也有所改善。這些積極的發展增加了我們疼痛產品組合的價值以及我們公司的內在價值。

We remain focused on creating long-term value for our shareholders through our capital deployment strategy. We are locked into rapidly deleveraging the balance sheet. To date, we have repaid $283.3 million of the Pharmakon loan, inclusive of $45.8 million in the first quarter, ending the quarter with net debt to adjusted EBITDA of less than 1 times.

我們仍然專注於透過資本部署策略為股東創造長期價值。我們陷入了快速去槓桿化資產負債表的困境。迄今為止，我們已償還 Pharmakon 貸款 2.833 億美元，其中包括第一季的 4,580 萬美元，本季末淨債務與調整後 EBITDA 比率不到 1 倍。

In addition, the call option on our 2026 convertible notes was triggered by our strong stock performance, enabling us to redeem the $26.4 million total principal amount of the notes in all cash. We expect that transaction to settle in June.

此外，我們強勁的股票表現觸發了 2026 年可轉換票據的看漲期權，使我們能夠以全部現金贖回票據本金總額 2,640 萬美元。我們預計交易將於六月結算。

This strategic use of our capital strengthens our balance sheet by reducing debt, positively impacting full-year diluted EPS, and potentially reducing some technical short positions in our stock. We expect to repay an additional $137.5 million of the Pharmakon loan in the remainder of 2024, which would put us at a de minimis net debt to adjusted EBITDA ratio at yearend.

這種對我們資本的策略性利用透過減少債務來增強我們的資產負債表，對全年攤薄每股收益產生積極影響，並可能減少我們股票中的一些技術性空頭部位。我們預計將在 2024 年剩餘時間內額外償還 1.375 億美元的 Pharmakon 貸款，這將使我們在年底的淨債務與調整後 EBITDA 的比率達到最低水準。

We have a strong track record of returning in value to our shareholders through share repurchases and are committed to opportunistically leveraging our $150 million share repurchase program as part of our capital deployment strategy. The recently announced $35 million accelerated share repurchase program reflects our confidence in the strength of the business, which was recently bolstered by the positive developments related to our pain portfolio.

我們在透過股票回購為股東帶來價值方面擁有良好的記錄，並致力於機會性地利用我們 1.5 億美元的股票回購計劃作為我們資本部署策略的一部分。最近宣布的 3500 萬美元加速股票回購計劃反映了我們對業務實力的信心，最近與我們的疼痛產品組合相關的積極發展增強了我們的信心。

We believe that there continues to be a disconnect between the intrinsic value of the company and our share price, which enables us to continue to opportunistically return value to our shareholders by leveraging our share repurchase program.

我們認為，公司的內在價值與我們的股價之間仍然存在脫節，這使我們能夠繼續利用我們的股票回購計劃，並機會主義地向股東回報價值。

I will now turn it over to Scott to give a commercial update.

我現在將把它交給斯科特來提供商業更新。

Thanks, Colleen. At Collegium, we're proud to be the leader in responsible pain management and to offer a differentiated portfolio of products for the treatment of pain. BELBUCA, Xtampza ER, and Nucynta ER have a combined 50% share of the branded ER market, demonstrating the ongoing strength and reach of our portfolio.

謝謝，科琳。在 Collegium，我們很自豪能夠成為負責任的疼痛管理領域的領導者，並提供差異化的疼痛治療產品組合。BELBUCA、Xtampza ER 和 Nucynta ER 合計佔據品牌 ER 市場 50% 的份額，證明了我們產品組合的持續實力和影響力。

Our commercial organization is dedicated to making a positive impact on the lives of people living with pain in the communities we serve. BELBUCA and Xtampza ER are well positioned for growth this year, and the Nucynta Franchise continues to be a key contributor.

我們的商業組織致力於對我們服務的社區中遭受痛苦的人們的生活產生積極影響。BELBUCA 和 Xtampza ER 今年的成長處於有利地位，而 Nucynta 特許經營權仍然是關鍵貢獻者。

We accelerated momentum for BELBUCA in the first quarter. We achieved year-over-year BELBUCA prescription growth of 4.2% during a time period where we have historically seen a decline in prescription volume due to typical first-quarter dynamics where deductibles reset, and out-of-pocket costs increase for patients. We're encouraged by these positive prescription trends and the impact of our strong commercial execution.

我們在第一季加速了 BELBUCA 的發展勢頭。我們的 BELBUCA 處方量年增了 4.2%，而在此期間，由於典型的第一季免賠額重置和患者自付費用增加，我們歷來看到處方量下降。這些正面的處方趨勢和我們強大的商業執行力的影響令我們感到鼓舞。

We believe Schedule III products should be used before Schedule II and used more broadly. BELBUCA is uniquely positioned because of its clinical differentiation as a Schedule III product with a broad range of doses for the management of severe and persistent pain that requires an extended treatment period. Our commercial team remains focused on delivering this message to healthcare professionals and strengthening execution.

我們認為，附表 III 產品應在附表 II 之前使用，並得到更廣泛的使用。BELBUCA 具有獨特的地位，因為它作為 Schedule III 產品的臨床差異化，具有廣泛的劑量範圍，用於治療需要延長治療時間的嚴重和持續性疼痛。我們的商業團隊仍然專注於向醫療保健專業人員傳遞此訊息並加強執行力。

Our priorities for BELBUCA include pulling through BELBUCA's strong commercial access, improving push-through in Medicare Part D and expanding Medicare Part D coverage. BELBUCA revenue growth in 2024 is expected to be driven by prescription growth.

我們對 BELBUCA 的優先事項包括利用 BELBUCA 強大的商業准入、改善 Medicare D 部分的推進以及擴大 Medicare D 部分的覆蓋範圍。預計 2024 年 BELBUCA 的營收成長將由處方成長推動。

In the first quarter, as expected, we saw pressure on prescriptions driven by plans where Xtampza ER was removed from formulary on January 1 after our contract renegotiations, as well as by the typical first-quarter dynamics. We're encouraged that after the initial impact on prescriptions from those events, prescription trends are showing signs of stabilization beginning in March.

正如預期的那樣，在第一季度，我們看到了處方壓力，這是由於合約重新談判後 Xtampza ER 於 1 月 1 日從處方藥中刪除的計劃以及典型的第一季度動態所驅動的。我們感到鼓舞的是，在這些事件對處方產生初步影響之後，處方趨勢從三月開始顯示出穩定的跡象。

Our priorities for Xtampza ER for the remainder of 2024 are clear. We're focused on stabilizing Xtampza ER prescriptions by educating physicians on Xtampza ER's differentiated label and pulling through Xtampza ER's strong access position in commercial and Part D plans. Our aspiration is to replace OxyContin utilization for appropriate patients. Importantly, we now have the gross-to-net headroom to secure new payer wins, which is a priority moving forward.

我們在 2024 年剩餘時間內的 Xtampza ER 優先事項很明確。我們致力於透過向醫生宣傳 Xtampza ER 的差異化標籤並利用 Xtampza ER 在商業和 D 部分計劃中的強大准入地位來穩定 Xtampza ER 處方。我們的願望是為合適的患者取代奧施康定。重要的是，我們現在擁有毛淨額空間來確保新的付款人獲勝，這是前進的首要任務。

The Nucynta Franchise is a key contributor to our pain portfolio. Tapentadol is a differentiated molecule with a proposed dual mechanism of action. It's viewed favorably and highly differentiated by healthcare professionals. Our market access strategy and our authorized generic agreement with Hikma enables us to manage the Nucynta Franchise contribution in a relatively stable manner year on year beginning in 2025 and beyond.

Nucynta 特許經營權是我們疼痛產品組合的關鍵貢獻者。他噴他多是一種獨特的分子，具有雙重作用機制。它受到醫療保健專業人士的青睞和高度評價。我們的市場准入策略以及與 Hikma 的授權通用協議使我們能夠從 2025 年及以後開始以相對穩定的方式逐年管理 Nucynta 特許經營權的貢獻。

In closing, we're encouraged by our performance in the first quarter and the trends that we're seeing across the pain portfolio. We're focused on achieving our 2024 commercial objectives through operational execution.

最後，我們對第一季的業績以及我們在疼痛產品組合中看到的趨勢感到鼓舞。我們致力於透過營運執行實現 2024 年商業目標。

I'll now turn the call back to Joe.

我現在將電話轉回給喬。

Thanks, Scott. Collegium is on track to deliver another year of record financial performance in 2024 while strategically deploying capital to create value for shareholders. Importantly, the outlook for the business in 2025 and beyond continues to meaningfully improve. Collegium is well positioned with a strong leadership team in place to drive future growth and create long-term value.

謝謝，斯科特。Collegium 預計將在 2024 年再創紀錄的財務業績，同時策略性地部署資本，為股東創造價值。重要的是，2025 年及以後的業務前景將繼續顯著改善。Collegium 擁有強大的領導團隊，能夠推動未來成長並創造長期價值。

I will now open the call up for questions. Operator?

我現在將開始提問。操作員？

(Operator Instructions) David Amsellem, Piper Sandler.

（操作說明）David Amsellem、Piper Sandler。

Hey, thanks. So just on the transition, I guess a couple of questions. Why now? Number one. And number two, does this at all signal any change in how you're thinking about business development priorities going forward?

嘿，謝謝。關於過渡，我想有幾個問題。為什麼現在？第一。第二，這是否表示您對未來業務發展優先事項的看法發生了任何變化？

Or maybe put differently, does it signal any sort of daylight between how you're thinking about the direction of the company broadly speaking versus how the Board is thinking about it? I just want to better understand what is driving the change, why now, and what it means for the direction of the company, particularly as it relates to your business development objectives. Thank you.

或者換句話說，這是否表明您對公司整體方向的看法與董事會對公司方向的看法之間有任何區別？我只是想更了解是什麼推動了變革，為什麼是現在，以及它對公司方向意味著什麼，特別是因為它與您的業務發展目標相關。謝謝。

Sure. So David, this is Joe. I'll start, and then I'll hand it off to Mike for some comments. So first off, in terms of the why now, I think it's really the right time for this leadership transition. The company is in a strong position. The company has a very strong culture of committed people.

當然。大衛，這是喬。我先開始，然後將其交給麥克徵求一些意見。首先，就為什麼現在而言，我認為現在確實是領導層過渡的最佳時機。該公司處於強勢地位。該公司擁有非常濃厚的敬業文化。

2024 is on track to be a record financial performance. The outlook continues to improve in terms of 2025 and beyond. And I think importantly, we have a very strong and competent management team. In addition, I think we're in a unique position by having Mike as our Chairman, given his history and track record of success with the company to be able to step in on an interim basis.

2024 年財務業績可望創歷史新高。2025 年及以後的前景將持續改善。我認為重要的是，我們擁有一支非常強大且有能力的管理團隊。此外，我認為麥克擔任我們的董事長，考慮到他在公司的歷史和成功記錄，我們處於一個獨特的位置，能夠臨時介入。

As it pertains to strategy, what I would emphasize, and I think this is important, the strategy of Collegium is a strategy that was collaboratively developed with the Board and the management team. And it's the management team that has been executing that strategy with the full support of the Board. So it's in no way indicative of change.

至於策略，我要強調的是，我認為這很重要，Collegium的策略是與董事會和管理團隊合作制定的策略。管理團隊在董事會的全力支持下一直在執行該策略。因此，這絕不意味著變化。

And with that, I'll hand it off to Mike for any comments that he wants to share.

至此，我會將其轉交給麥克，以徵求他想要分享的任何意見。

Great. Thanks, Joe. And David, thanks for the question. First, I'd like to thank Joe personally and on behalf of the entire Board for his tremendous leadership and his many accomplishments as the Collegium's CEO for the last six years. When I stepped down as the CEO in 2018 and Joe took the role, I could have only hoped for the success that he has driven at the company.

偉大的。謝謝，喬。大衛，謝謝你的提問。首先，我個人並代表整個董事會感謝 Joe 在過去六年中作為 Collegium 首席執行官的卓越領導才能和取得的諸多成就。當我於 2018 年辭去執行長職務並由喬接任時，我只能寄望他為公司帶來的成功。

As Joe said, the company is in a very strong position financially and is poised for the next phase of growth. And the Board is confident that our ongoing search process will identify a world-class leader that will fill Joe's large shoes and take the company to the next phase of growth. We are committed to the strategy. We are committed to the capital deployment strategy, and we're committed to the BD strategy. So that remains unchanged, as Joe articulated.

正如喬所說，該公司的財務狀況非常強勁，並為下一階段的成長做好了準備。董事會相信，我們正在進行的搜尋過程將找到一位世界級的領導者來填補喬的空缺，並帶領公司進入下一階段的成長。我們致力於該戰略。我們致力於資本配置策略，我們致力於BD策略。因此，正如喬所闡述的那樣，這一點保持不變。

Great. Thank you.

偉大的。謝謝。

Thanks, David.

謝謝，大衛。

Tim Lugo, William Blair.

提姆·盧戈，威廉·布萊爾。

Hey, team. This is John on for Tim. Thanks so much for taking our question. So I just want to say congrats on the progress with BELBUCA. And I know in the past, you've said that that's a little bit more of a complicated product that's required some extra physician education. Just wondering if you can give us some idea of how much of that growth you contribute to the new sales initiative around improving that education. And maybe as a follow-up, how much more runway do you see for that product to grow?

嘿，團隊。這是約翰替提姆發言。非常感謝您提出我們的問題。所以我只想對 BELBUCA 的進展表示祝賀。我知道，您過去曾說過，這是一種更複雜的產品，需要一些額外的醫生教育。只是想知道您是否可以告訴我們您為圍繞改善教育的新銷售計劃貢獻了多少增長。或許作為後續行動，您認為該產品還有多少成長空間？

Yeah. So, John, thanks for the question, and I'll hand those two questions off to Scott.

是的。所以，約翰，謝謝你提出這個問題，我將把這兩個問題交給史考特。

Yeah. Thanks, John. Appreciate the question. And yeah, we really are encouraged by the growth in the first quarter of 4.2% and how the momentum's continued to accelerate, especially given that the first quarter historically has growth headwinds with one quarter, 1Q dynamics. So we're encouraged by that.

是的。謝謝，約翰。感謝這個問題。是的，我們確實對第一季 4.2% 的成長以及這一勢頭的持續加速感到鼓舞，特別是考慮到第一季歷來都面臨著第一季的成長阻力。所以我們對此感到鼓舞。

It is driven by execution. I mean, we put a lot of work and energy into training our team to be as effective as they possibly can be, and we will continue to do so. And look, we expect full-year growth, we expect prescription growth to drive revenue growth going forward, and we're encouraged by what could be on the horizon.

它是由執行力驅動的。我的意思是，我們投入了大量的工作和精力來培訓我們的團隊，使其盡可能高效，我們將繼續這樣做。看，我們預計全年成長，我們預計處方成長將推動未來收入成長，我們對即將發生的事情感到鼓舞。

Thanks. That's helpful.

謝謝。這很有幫助。

You're welcome.

不客氣。

Serge Belanger, Needham & Company.

謝爾蓋貝蘭格 (Serge Belanger)，李約瑟公司。

Hi, everyone. Good afternoon and thanks for taking my question. This is John on for Serge.

大家好。下午好，感謝您提出我的問題。這是謝爾蓋的約翰。

First, regarding the agreement with Hikma, can you provide any context, I guess, beyond into potential other generic competitors who might enter the market in the future? And if that does happen, what the impact of those other generics could have on your deal with Hikma? Thanks.

首先，關於與 Hikma 的協議，我想，除了未來可能進入市場的潛在其他通用競爭對手之外，您能否提供任何背景資訊？如果這種情況確實發生，其他仿製藥會對您與 Hikma 的交易產生什麼影響？謝謝。

Sure. So, John, thanks for the question. I'll start on that and then hand it off to Colleen. I think with the Hikma agreement, one, we're really excited to be partnered with an industry leader and well-respected organization. When you look at Nucynta ER, what the Hikma agreement does is it secures a scenario beyond our base case.

當然。所以，約翰，謝謝你的提問。我將從這個開始，然後將其交給科琳。我認為，透過 Hikma 協議，我們非常高興能夠與行業領導者和備受尊敬的組織合作。當您查看 Nucynta ER 時，您會發現 Hikma 協議的作用是確保超出我們基本案例的場景。

And as we've talked about in the past, we really want to bring focus to Teva as a domino that transcends the portfolio because whether they launch or not, will be an interesting event for the organization. To the degree that they don't, what the Hikma agreement enables is us to realize the vast majority of our upside economics. And Colleen, I don't know if there's anything that you want to add there.

正如我們過去所討論的那樣，我們確實希望將 Teva 視為超越產品組合的骨牌，因為無論它們是否推出，對於該組織來說都將是一個有趣的事件。在某種程度上，他們沒有做到這一點，希克馬協議使我們能夠實現絕大多數的經濟成長。科琳，我不知道你是否還有什麼要補充的。

Yeah. Maybe just building up on that, I would say that this agreement gives us the certainty that there is only one potential entrant for Nucynta ER before 2028 and that's Teva. And if Teva doesn't launch, we secure nearly all of the value in our upside scenario due to the favorable profit share and the impact on the royalties.

是的。也許在此基礎上，我想說的是，這項協議讓我們確信，在 2028 年之前 Nucynta ER 只有一個潛在進入者，那就是 Teva。如果 Teva 沒有推出，由於有利的利潤份額和對特許權使用費的影響，我們在上行情境中幾乎獲得了所有價值。

Great. Thank you.

偉大的。謝謝。

You're welcome.

不客氣。

Les Sulewski, Truist Securities.

Les Sulewski，Truist 證券公司。

Good evening. Thank you for taking my questions. On BELBUCA, how much of that 4.2% script growth was driven by the new Medicare Part D contribution? And then second, as we kind of look into the future of Xtampza renegotiations after your successful rounds for the past year or two, would you expect those to be even more favorable or in line and stable as we have progressed? Thank you.

晚安.感謝您回答我的問題。在 BELBUCA 上，4.2% 的腳本成長有多少是由新的 Medicare D 部分貢獻推動的？其次，在過去一兩年你們成功進行了幾輪談判之後，我們對 Xtampza 重新談判的未來進行了展望，您是否認為隨著我們的進展，這些談判會變得更加有利或一致和穩定？謝謝。

Yeah. So Les, I'm going to hand the BELBUCA question off to Scott.

是的。所以，萊斯，我會把貝爾布卡問題交給史考特。

Yeah. Thanks, Les. So yeah, when we look at BELBUCA, that win was 1 million lives. So the vast majority of the growth is actually not driven by that win because it was a smaller amount of lives that were added. It's mostly through the overall growth of our portfolio.

是的。謝謝，萊斯。所以，是的，當我們看看 BELBUCA 時，這場勝利就是 100 萬人的生命。因此，絕大多數的成長實際上並不是由這場勝利推動的，因為增加的生命數量較少。這主要是透過我們投資組合的整體成長來實現的。

And then, Les, with regards to Xtampza ER, we're now in a position post having renegotiated 85% of all contracts this cycle, where how Xtampza grows year to year will be dependent upon what we accomplish in the payer landscape. So the first thing I want to emphasize is the confidence we have of Xtampza being able to consistently grow revenue each year as we move forward. So in 2025 and beyond.

然後，Les，關於 Xtampza ER，我們現在已經重新談判了本週期 85% 的合同，Xtampza 的逐年增長將取決於我們在付款人領域取得的成就。因此，我要強調的第一件事是，我們對 Xtampza 能夠在不斷前進的過程中每年持續成長收入充滿信心。所以在 2025 年及以後。

When you think about the headroom we have, when we report or when the team reports in November, Xtampza grow, if you'll then have an understanding whether it will be driven by new plans that drive prescriptions and/or renegotiations that also have the potential to improve margins. So it will be a year-to-year scenario, but the thing that we are confident in is the ability to consistently grow revenue.

當您考慮我們擁有的空間時，當我們報告或團隊在11 月報告時，Xtampza 會增長，如果您隨後會了解它是否會受到新計劃的推動，這些計劃會推動處方和/或重新談判，這些計劃也具有提高利潤率的潛力。因此，這將是一個逐年的情況，但我們有信心的是持續成長收入的能力。

And the one thing I would emphasize, that is in 2025, we also get a pretty meaningful benefit from the Medicare Part D redesign, which will serve as a tailwind, in particular for Xtampza.

我要強調的一件事是，到 2025 年，我們也從 Medicare D 部分重新設計中獲得了相當有意義的好處，這將成為一種順風，特別是對於 Xtampza 而言。

All right. Thank you.

好的。謝謝。

Oren Livnat, H.C. Wainwright.

奧倫·利夫納特，H.C.溫賴特。

Thanks. Joe, you segued right into my question there. I was hoping to get a little more clarity around that Xtampza ER 2025 tailwind. Is that something that can help you renew prescription growth in 2025 and beyond? Or is that indirectly another economic or unit value benefit similar to what we've seen recently with stepdown gross to net? I have a follow-up. Thanks.

謝謝。喬，你直接切入了我的問題。我希望能更清楚地了解 Xtampza ER 2025 的順風車。這是否可以幫助您在 2025 年及以後恢復處方成長？或者，這是否是間接的另一種經濟或單位價值效益，類似於我們最近看到的毛額降為淨額的情況？我有一個後續行動。謝謝。

Yeah. Thanks for the question, Oren. I'll start by saying it's not a prescription benefit dynamic, and I'll hand off the Colleen to explain the impact of the Part D redesign and in particular, in our portfolio, why Xtampza benefits.

是的。謝謝你的提問，奧倫。我首先要說的是，這不是處方福利動態，然後我將向 Colleen 解釋 D 部分重新設計的影響，特別是在我們的產品組合中，為什麼 Xtampza 受益。

Thanks for the question, Oren. So yeah, the Medicare Part D redesign, the benefit that we speak about is all in the gross to net. So coverage gap, or donut hole as we know it today, goes away completely. And manufacturers and payers in the end pay a larger proportion and patient out-of-pocket is limited.

謝謝你的提問，奧倫。所以，是的，醫療保險 D 部分重新設計，我們所說的好處都是從整體到淨值。因此，覆蓋差距，或者我們今天所知道的甜甜圈洞，完全消失了。而製造商和付款人最終支付的比例較大，而患者自付費用有限。

With the small manufacturer phase-in, our portion of that payment starts phasing in at 1% and goes up through a number of years till seven years through. So that's what that refers to. Solid gross to net benefit and it's associated with the phase-in for small manufacturers starting at once this point and going up from there.

隨著小型製造商的逐步實施，我們支付的部分開始以 1% 的比例逐步增加，並持續數年直至七年。這就是它所指的。穩健的總收益與淨收益之比與小型製造商從此時開始並從此開始逐步採用有關。

So just so I'm clear, philosophically or essentially or at a high level, we're talking about the amount you have to pay in as a small company is less than the amount you've been having to cover in the donut hole essentially?

所以我很清楚，從哲學上或本質上或在高層次上來說，我們談論的是作為一家小公司你必須支付的金額基本上少於你在甜甜圈洞中必須支付的金額？

That's right. It will be less than what we have to cover this year and then phase back in over a number of years up to the level we pay in 2024.

這是正確的。這將低於我們今年必須支付的金額，然後在幾年內逐步回滾到 2024 年我們支付的水平。

Okay. And speaking of gross to net, your Q1 Xtampza gross was a little higher than I modeled. I can't speak for what you were expecting. Is it possible that this year it's going to have a flatter cadence or a narrower range through the year than maybe we saw last year or two?

好的。說到毛淨值，您的第一季 Xtampza 毛額比我建模的要高一些。我無法說出你所期待的。今年是否有可能比我們去年或兩年看到的節奏更平坦或範圍更窄？

Yeah. First, I would say Xtampza is performing in line with our expectations, the Q1 gross to net at 53.6%. You will still see in Q2, Q3 that eroded a bit because of the donut hole impact. But you're right, it's not quite as steep of an impact in the quarter. And from a full-year perspective, we're guiding to 56% to 58%, which is an improvement over nearly 60% last year.

是的。首先，我想說 Xtampza 的表現符合我們的預期，第一季毛淨率為 53.6%。由於甜甜圈洞的影響，您仍然會在第二季和第三季看到一些侵蝕。但你是對的，本季的影響並沒有那麼嚴重。從全年來看，我們的目標是 56% 到 58%，比去年近 60% 有所提升。

Okay. And you cut out earlier on the call for me. What were you saying about someone getting a CRL on a generic BELBUCA? Sorry, I make you repeat that.

好的。你早些時候掛斷了我的電話。您對某人獲得通用 BELBUCA 的 CRL 有何看法？抱歉，我請你重複一遍。

Yeah. [Shammo], which was the third ANDA filer for BELUCA, has recently received its fourth CRL.

是的。 [Shammo] 是 BELUCA 的第三個 ANDA 申報者，最近收到了第四個 CRL。

Okay. And there's no fourth or fifth filer, if I recall, right? So we have clarity. If they're not there, it's just between Teva with an uncertain launch when their time comes and Alvogen blocked for a long time, correct?

好的。如果我沒記錯的話，沒有第四個或第五個申報者，對吧？所以我們很清楚。如果他們不在那裡，那就只是 Teva 在他們的時間到來時不確定的發射和 Alvogen 被封鎖很長時間之間的問題，對嗎？

Blocked till 2032.

封鎖至 2032 年。

Thank you so much. And Joe, it's been fun working with you, man.

太感謝了。喬，和你一起工作很有趣，夥計。

Thanks, Oren. It's been a lot of fun working with you too.

謝謝，奧倫。和你一起工作也很有趣。

Thank you. And there are no further questions at this time. I will now hand the floor back to Joe Ciaffoni for closing.

謝謝。目前沒有其他問題。現在我將把發言權交還給喬·恰福尼 (Joe Ciaffoni) 進行結束。

Thank you, everyone, for joining the call today. I hope you all have a great evening.

謝謝大家今天加入電話會議。希望大家有個愉快的夜晚。

Thank you. And with that, we conclude today's conference. All parties may disconnect. Have a good day.

謝謝。我們今天的會議就到此結束。所有各方都可以斷開連接。祝你有美好的一天。