Q4 2023 Collegium Pharmaceutical Inc Earnings Call

Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during this conference call, please press star zero on your telephone key.

And the answer session will follow the formal presentation. If anyone should require operator assistance. During this conference call. Please press star zero on your telephone keypad. Please note that this conference call is being recorded I will now I'll turn the call over to Christopher James Vice President Investor Relations.

Operator: 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 Google. Thank you. You may begin.

Christopher Shayne James: Thank you you may begin.

Christopher Shayne James: Welcome to Collegium Pharmaceutical's fourth quarter and full year 2023 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.

Christopher Shayne James: Welcome to Collegium Pharmaceuticals fourth quarter and full year 2023 earnings conference call I'm joined today by Joseph Pony, Our Chief Executive Officer, Cleans up our our Chief Financial Officer, and Scott Dreyer, Our Chief commercial officer before we begin today's call we want to remind participants that none of the information presented today is <unk>.

Christopher Shayne James: 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. Your caution that such forward-looking statements involve risks and uncertainties, including, without limitation, the risk that we may not be able to successfully commercialize our products, that we may incur significant expenses, and that we may not prevail in current or future litigation pertaining to our products. These risks and other risks of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission.

Christopher Shayne James: <unk> tended 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, 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.

Christopher Shayne James: And that we may not prevail in current or future litigation pertaining to our business. These risks and other rest of the company are detailed in the company's periodic reports filed with the Securities and Exchange Commission.

Christopher Shayne James: Our future results may differ materially from our current expectations discussed today. Our earned express relief on 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. I will now turn the call over to our CEO, Joe Ciaffoni. Thank you, Chris.

Christopher Shayne James: Future results may differ materially from our current expectations discussed today.

Christopher Shayne James: Our earnings press release on this call will include discussion of certain non-GAAP information.

Christopher Shayne James: You can find our earnings press release, including relevant non-GAAP reconciliations on our corporate website at Collegium pharma Dot Com I will now turn the call over to our CEO Joseph Oney.

Joseph J. Ciaffoni: Thank you Chris Good afternoon, and thank you everyone for joining the call today, we will discuss our performance during the fourth quarter and full year 2023, and our focus on operational execution in 2024.

Joseph J. Ciaffoni: Good afternoon, and thank you, everyone, for joining the call. Today, we will discuss our performance during the fourth quarter of full year 2023 and our focus on operational execution in 2024. As we build 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. We are proud of our partnerships with organizations to drive equitable access to STEM education in underserved communities. As part of this commitment, we recently launched the Collegium Pharmaceutical Scholarship Program through which we will award two full scholarships to Massachusetts-based high school seniors pursuing a STEM-related major at a U.S. university. We are proud to provide this opportunity to students who have demonstrated financial need, academic achievement, leadership, community service, and a commitment to learning as they pursue a career in STEM. Also, yesterday, we published our 2023 ESG report, which reflects our commitment to operating with responsibility, integrity, and purpose. I encourage you to read the report on our website.

As we build 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 we.

Joseph J. Ciaffoni: We are proud of our partnerships with organizations to drive equitable access to stem education and underserved communities as part of this commitment. We recently launched the Collegium pharmaceutical scholarship program for which we will award to full scholarships to Massachusetts based high school seniors pursuing a stem really.

Joseph J. Ciaffoni: <unk> major at a U S University, we are proud to provide this opportunity the students who have demonstrated financial need academic achievement leadership community service and a commitment to learning as they pursue a career in style.

Joseph J. Ciaffoni: Also yesterday, we published our 2023 ESG report, which reflects our commitment to operating with responsibility integrity and purpose I incurred I encourage you to read the report on our website.

Joseph J. Ciaffoni: I'd also like to recognize the Collegium team for their commitment to our mission and for their contributions and accomplishments in 2023. 2023 was a banner year for Collegium Pharmaceutical. We delivered on our financial commitments and executed our capital deployment strategy. Key accomplishments in 2023 include delivering record revenue and record adjusted EBITDA. We returned Belbuca to sequential quarterly prescription growth, starting in Q2 2023, and saw year-over-year quarterly growth in Q3 and Q4. In the fourth quarter, Belbuca total prescriptions grew 3.2% compared to Q4 2022. We expect to see Belbuca prescription growth in 2024. We successfully renegotiated a major Medicare Part D plan, accounting for 12% of Belbuca prescriptions, maintaining access and materially rolling back rebates. This will result in year-on-year gross net improvement. We also want a new Medicare Part D plan with approximately 1 million covered lives.

Joseph J. Ciaffoni: I'd also like to recognize the Collegium team for their commitment to our mission and for their contributions and accomplishments in 2023.

Joseph J. Ciaffoni: 2023 was a banner year for Collegium pharmaceutical we delivered on our financial commitments and executed our capital deployment strategy.

Joseph J. Ciaffoni: Key accomplishments in 2023 include we delivered record revenue and record adjusted EBITDA, We returned BELBUCA to sequential quarterly prescription growth starting in Q2, 2023 and saw year over year quarterly growth in Q3, and Q4 in the fourth quarter BELBUCA.

Joseph J. Ciaffoni: Total prescriptions grew three 2% compared to Q4 2022, we expect to see Buffy BELBUCA prescription growth in 2024.

Joseph J. Ciaffoni: We successfully renegotiated a major Medicare part D plan accounting for 12% of BELBUCA prescriptions, maintaining access and materially rolling back rebates. This will result in year on year gross to net improvement.

We also won new Medicare part D plan, representing approximately 1 million covered lives.

Joseph J. Ciaffoni: We improved EXTAM's CER gross net in 2023 to 59.6%, a decrease of 9.7 percentage points over 2022. We successfully renegotiated contracts representing 30% of all expanse of ER prescriptions, maintaining access, and improving rebates in 57% of plants. We expect to see gross net improve to 56 to 58% in 2024. We received new patient population exclusivity for Nucynta, extending the period of U.S. exclusivity from June 27th, 2025 to July 3rd, 2026. We submitted a pediatric extension for the Nucenta franchise in December that, if approved, will extend the exclusivity of the franchise for an additional six months.

Joseph J. Ciaffoni: We improved the stamps E. Our gross to net in 2023 to 59, 6% a decrease of $9 seven percentage points over 2022.

We successfully renegotiated contracts, representing 30% of all extends the ER prescriptions, maintaining access and improving rebates and 57% of plans, we expect to see gross to net improved to 56% to 58% in 2024.

Joseph J. Ciaffoni: We received new patient population exclusivity for NUCYNTA, extending the period of U S. U S. Exclusivity from June 27, 2020 Fives to July three 2026, we submitted a pediatric extension for the NUCYNTA franchise in December that if approved will extend exclude.

Joseph J. Ciaffoni: 70 of the franchise and an additional six months, we expect a decision in the second half of 2020 for.

Joseph J. Ciaffoni: We expect a decision in the second half of 2024. The new patient population exclusivity for Nucyntha, together with the potential pediatric extension for the Nucyntha franchise, bolster our outlook for 2025 and 2026. We executed our capital deployment strategy, paying down $162.5 million in debt and returning $75 million in capital to our shareholders through our share repurchase program. And we ended the year with over $310 million in cash and market

Joseph J. Ciaffoni: The new patient population exclusivity for NUCYNTA together with the potential pediatric extension for the NUCYNTA franchise bolster our outlook in 2025 and 2026.

Joseph J. Ciaffoni: We executed our capital deployment strategy paying down $162 $5 million in debt and returning $75 million in capital to our shareholders through our share repurchase program.

Joseph J. Ciaffoni: We ended the year with over $310 million in cash and marketable securities.

Joseph J. Ciaffoni: Our record financial performance and operational achievements in 2023 position the organization for success in 2024 and beyond. We expect to deliver record revenue, adjusted EBITDA, free cash flow, and net income in 2024. In 2024, top-line growth will be fueled by Belbuca and Exstamza ER. We are encouraged by the Belbuca prescription growth we saw in the fourth quarter of 2023, and we expect to see full-year prescription growth in 2024 along with gross to net improvement. Over the past two years, we've renegotiated contracts representing 84% of all ex-stamps to ER prescriptions, maintaining access, and rolling back rebates in 77% of plans.

Joseph J. Ciaffoni: Our record financial performance and operational achievements in 2023 position the organization for success in 2024 and beyond.

Joseph J. Ciaffoni: We expect to deliver record revenue adjusted EBITDA free cash flow and net income in 2024.

In 2020 for top line growth will be fueled by BELBUCA and <unk> E R.

Joseph J. Ciaffoni: We are encouraged by the BELBUCA prescription growth we saw in the fourth quarter of 2023, and we expect to see full year prescription growth in 2024, along with gross to net improvement.

Joseph J. Ciaffoni: Over the past two years, we renegotiated contracts, representing 84% of all extends the ER prescriptions, maintaining access and rolling back rebates and 77% of plans. This is a major accomplishment that will fuel extensive E. Our revenue growth in 2024.

Joseph J. Ciaffoni: This is a major accomplishment that will fuel EXPAMCE-ER revenue growth in 2024. We expect gross net to improve to 56 to 58 percent. The team is working hard to mitigate anticipated pressure on prescriptions.

Joseph J. Ciaffoni: We expect gross to net to improve to 56% to 58%.

Joseph J. Ciaffoni: The team is working hard to mitigate anticipated pressure on prescriptions.

Joseph J. Ciaffoni: The Nucyntha franchise is a key contributor to our pain portfolio, but we do expect some pressure on Nucyntha franchise revenue in 2024 because of the American Recovery Act eliminating the Medicaid cap. Beginning in 2025, through loss of exclusivity, we expect to be able to deliver relatively stable year-on-year results. The new population exclusivity achieved for Nucynta in 2023 and the anticipated pediatric extensions for the franchise in 2024, along with a reduction in the royalties we pay on Nucynta franchise sales from 14 to 7 percent beginning on June 27, 2025, bolster our outlook for the franchise in 2025 and 20

The NUCYNTA franchise is a key contributor to our pain portfolio. We do expect some pressure on NUCYNTA franchise revenue in 2024, because of the American recovery Act, eliminating the Medicaid cap beginning.

Joseph J. Ciaffoni: Beginning in 2025 through loss of exclusivity, we expect to be able to deliver relatively stable year on year results.

Joseph J. Ciaffoni: The new population exclusivity achieve for NUCYNTA in 2023, and the anticipated pediatric extensions for the franchise in 2024, along with a reduction in the royalties we pay on NUCYNTA franchise sales from 14% to 7% beginning on June 27 2025.

Joseph J. Ciaffoni: Bolster our outlook for the franchise in 2025 and 2026.

Joseph J. Ciaffoni: In 2024, our focus is on operational execution. We are committed to achieving our financial objectives and deploying capital to create long-term value for our shareholders. We aim to achieve record financial performance while rapidly paying down debt and returning capital to our shareholders by opportunistically leveraging our $150 million share repurchase program. I am confident that we are well positioned to deliver on our financial and capital deployment objectives. I will now hand the call over to Colleen to discuss the finances. Thanks, Joe. Good afternoon, everyone.

Joseph J. Ciaffoni: In 2024, our focus is on operational execution, we are committed to achieving our financial objectives and deploying capital to create long term value for our shareholders.

Joseph J. Ciaffoni: We aim to achieve record financial performance, while rapidly paying down debt and returning capital to our shareholders by Opportunistically, leveraging our $150 million share repurchase program I am confident that we are well positioned to deliver on our financial and capital deployment objectives I will know him.

Joseph J. Ciaffoni: The call over to Colleen to discuss the financials.

Colleen: Thanks, Joe Good afternoon, everyone.

Colleen Tupper: 2023 was a banner year for Collegium in which we achieved all of our financial objectives. We generated record revenue and adjusted EBITDA on both a quarterly and full-year basis. We maintained our financial discipline and leveraged our strong cash flows to execute on our capital deployment strategy. Financial highlights for the fourth quarter and full year include net product revenues of a record 149.7 million for the fourth quarter, up 16% year-over-year; and 2023 net product revenues were a record $566.8 million, up 22% year over year. Bilbuka net revenue reached a record $49.3 million in the fourth quarter, up 17% year over year, and a record $182.1 million in 2023, up 44% year over year.

Colleen: 23, with a banner year for Collegium in which we achieved all of our financial objectives, we generated record revenue and adjusted EBITDA on both a quarterly and full year basis, we maintained our financial discipline and leverage our strong cash flows to execute on our capital deployment strategy.

Colleen: Financial highlights for the fourth quarter and full year include net product revenues were a record $149 7 million for the fourth quarter up 16% year over year.

Colleen: 2023, net product revenues were a record $566 8 million up 22% year over year.

Colleen: BELBUCA net revenue was a record $49 3 million in the fourth quarter up 17% year over year, and a record $182 1 million in 2023 up 44% year over year.

Colleen Tupper: 2023 sales reflect a full year of revenue compared to a partial year of revenue in 2022 due to the timing of the BDSI acquisition. For the fourth quarter, EXTAMSA ER net revenue was a record $48.5 million, up 38%, and EXTAMSA ER gross-to-net was 54.5%. For 2023, Expanse ER net revenue was a record $177.4 million, up 28%, and gross to net was $59.6%. We expect EXTAMSA ER gross to net to be in the range of 56 to 58 percent in 2024 as a result of the successful contract renegotiations we completed in 2023. Lucinda franchise net revenue was $46.9 million in the fourth quarter, down 2% year-over-year, and $190.8 million in 2023, up 3% year-over-year. GAAP operating expenses were $32.9 million in the fourth quarter, down 13% year over year. For 2023, GAAP operating expenses were $159.2 million, down 10% year over year. Non-GAAP adjusted operating expenses were $25.9 million in the fourth quarter, down 20% year over year.

Colleen: 2023 sales reflect a full year of revenue compared to a partial year of revenue in 2022 due to the timing of the BDSI acquisition.

Colleen: For the fourth quarter extends to our net revenue was a record $48 5 million up 38% and extends to our gross to net was 54, 5%.

Colleen: For 2023 extends to our net revenue was a record $177 4 million up 28% and a gross to net was 40 59, 6%.

Colleen: We expect <unk> ER gross to net to be in the range of 56% to 58% in 2024 as a result of the successful contract renegotiations, we completed in 2023.

NUCYNTA franchise net revenue was $46 9 million in the fourth quarter down 2% year over year and $198 million in 2023, 3% year over year.

Colleen: GAAP operating expenses were $32 9 million in the fourth quarter down 13% year over year for 2023, GAAP operating expenses were $159 2 million down 10% year over year.

Colleen: non-GAAP adjusted operating expenses were $25 9 million in the fourth quarter down 20% year over year for 2023, adjusted operating expenses were $123 6 million up 1% year over year.

Colleen Tupper: For 2023, adjusted operating expenses were $123.6 million, up 1% year-over-year. Gap net income for the fourth quarter was $31.9 million compared to a net loss of $7.2 million in the fourth quarter of 2020. For 2023, net income was $48.2 million compared to a net loss of $25 million. Non-GAAP-adjusted EBITDA was a record $104.2 million for the fourth quarter, up 36% year-over-year, and a record $367 million for full year 2023, up 38%. Gap earnings per share was $0.99 basic and $0.82 diluted in the fourth quarter compared to gap loss per share of $0.21 basic and diluted in the prior year period.

Colleen: GAAP net income for the fourth quarter was $31 9 million compared to a net loss of $7 2 million in the fourth quarter of 2022 for 2023 net income was $48 2 million compared to a net loss of $25 million in 'twenty two.

Colleen: non-GAAP adjusted EBITDA was a record $104 2 million for the fourth quarter up 36% year over year and a record 367 million for full year 2023 up 38%.

Colleen: GAAP earnings per share was <unk> 99, basic and 82 cents diluted in the fourth quarter compared to GAAP loss per share of <unk> 21, basic and diluted in the prior year period.

Colleen Tupper: Gap earnings per share was $1.43 basic and $1.29 diluted in 2023 versus gap loss per share of $0.74 basic and diluted in 2023. Non-GAAP-adjusted earnings per share was $1.58 in the fourth quarter versus $1.09 in the fourth quarter of 2012. For 23, non-GAAP-adjusted earnings per share was $5.47 versus $3.96 in the prior year.

Colleen: GAAP earnings per share was $1 43, basic and $1.29 diluted in 2023 versus GAAP loss per share <unk> 74 basic and diluted in 2022.

Colleen: non-GAAP adjusted earnings per share was $1 58 in the fourth quarter versus $1 nine in the fourth quarter of 'twenty two.

Colleen: 423, non-GAAP adjusted earnings per share was $5 47 versus $3.96 in the prior year. Please.

Colleen Tupper: Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results. In 2023, we generated robust operating cash flows of $274.7 million and ended the year with cash, cash equivalents, and marketable securities of $310.5 million. For the year, Collegium paid down $162.5 million in debt, ending the year with leverage of approximately one times net debt to adjusted EBITDA.

Colleen: Please see our press release issued earlier today for a reconciliation of GAAP to non-GAAP results in.

Colleen: In 2023, we generated robust operating cash flows of $274 7 million and ended the year with cash cash equivalents and marketable securities of $310 5 million.

Colleen: For the year Collegium paid down $162 $5 million in debt ending the year with leverage of approximately one times net debt to adjusted EBITDA.

Colleen Tupper: We are encouraged by our strong performance in the fourth quarter and full year 2020. We achieved our financial goals for the year, growing Adjusted EBITDA at more than one and a half times the rate of revenue, increasing our cash position, and positioning us to deliver on our financial commitments in 2024. We reaffirm our 2024 financial guidance, which we announced earlier this year. We expect net product revenues in the range of $580 to $595 million. We expect adjusted operating expenses in the range of $120 to $125 million and adjusted EBITDA in the range of $380 to $395 million.

Colleen: We are encouraged by our strong performance in the fourth quarter and full year 2023.

Colleen: We achieved our financial goals for the year growing adjusted EBITDA more than one five times the rate of revenue, increasing our cash position and positioning us to deliver on our financial commitments in 2024.

Colleen: We reaffirm our 2024 financial guidance, which we announced earlier this year, 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.

Colleen: Two $395 million, we are confident in our ability to deliver on our financial commitments in 2024.

Colleen Tupper: We are confident in our ability to deliver on our financial commitments in 2020. We are focused on creating long-term value for our shareholders through our capital deployment strategy. We are rapidly paying down debt and plan to opportunistically return capital to shareholders through share repurchase. We are locked into rapidly deleveraging the balance sheet, paying down over $180 million of debt in 2024, which would put us at a de minimis net debt to adjusted EBITDA ratio at year end. Our ability to do levers quickly is a testament to our strong cash generation. We have a strong track record of returning value to our shareholders. Since 2021, we've returned $137 million of capital to our shareholders at an average price of $21.65 per share through a combination of the open market and an accelerated share repurchase program. In 2023, we repurchased $75 million through accelerated share repurchase programs, including $25 million repurchased at an average price per share of $27.09 since November. In January, our board authorized a new share repurchase program to repurchase up to $150 million of common stock over 18 months.

Colleen: We are focused on creating long term value for our shareholders through our capital deployment strategy, we are rapidly paying down debt and plan to Opportunistically return capital to shareholders through share repurchases.

Colleen: We are locked into rapidly deleveraging the balance sheet paying down over $180 million of debt in 2024, which would put us at de Minimis net debt to adjusted EBITDA ratio at year end.

Colleen: Our ability to Delever quickly is a testament to our strong cash generation.

Colleen: We have a strong track record of returning value to our shareholders. Since 2021, we've returned $137 million of capital to our shareholders at an average price of $21 65 per share through a combination of open market and accelerated share repurchase programs in 2023, we repurchase.

Colleen: $75 million through accelerated share repurchase programs, including $25 million repurchased at an average price per share of $27.09 since November.

Colleen: In January our board authorized a new share repurchase program to repurchase up to $150 million in common stock over 18 months, we believe that our stock continues to be undervalued and we view our share repurchase program as a productive use of our capital to generate high returns for our.

Scott Dreyer: We believe that our stock continues to be undervalued, and we view our share repurchase program as a productive use of our capital to generate high returns for our shareholders. I will now turn it over to Scott to give him his commercial. Thanks, Colleen. At Collegium, we're proud to be the leader in responsible pain management. Belbuca, Extamsa ER, and NuCyntha ER have a combined 50% share of the branded ER market.

Colleen: <unk>.

Colleen: I will now turn it over to Scott to give the commercial update.

Scott: Thanks Colleen.

Scott: Collegium, we're proud to be the leader in responsible pain management BELBUCA extents. The E. R of NUCYNTA ER have a combined 50% share of the branded ER market. Our pain portfolio is highly differentiated and our commercial organization is focused on maximizing the potential of our products to have a positive impact on the lives of people living with pain and the <unk>.

Scott Dreyer: Our pain portfolio is highly differentiated, and our commercial organization is focused on maximizing the potential of our products to have a positive impact on the lives of people living with pain and the communities that we serve. We ended 2023 with momentum across the pain portfolio. Belbuca and Extamsa ER are well positioned for growth in 2024, and the NuCyntha franchise will be a key contributor. In the fourth quarter, Belbuca total prescriptions grew 3.2% year-over-year and 1% quarter-over-quarter, continuing the sequential quarterly growth that started in the second quarter of 2023, when we initiated the prescription trajectory of Belbuca.

Scott: <unk> that we serve we ended 2023 with momentum across the pain portfolio.

Scott: Buchanan extensive E are well positioned for growth in 2024, and the NUCYNTA franchise will be a key contributor.

Scott: In the fourth quarter BELBUCA total prescriptions grew three 2% year over year, and 1% quarter over quarter, continuing the sequential quarterly growth that started in the second quarter of 2023, when we inflicted the prescription trajectory of BELBUCA.

Scott: As the leader in responsible pain management, we believe that schedule III products should be used before scheduled to end used more broadly we're encouraged that the buprenorphine market continues to grow we believe BELBUCA is uniquely positioned because of its clinical differentiation as a schedule III product with a broad range of doses for the management of <unk>.

Scott Dreyer: As the leader in responsible pain management, we believe that Schedule 3 products should be used before Schedule 2 and used more broadly. We're encouraged that the buprenorphine market continues to grow. We believe 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 extended treatment.

Scott: Beer and persistent pain that requires an extended treatment period.

Scott: Our commercial accomplishments in 2023 position BELBUCA for growth in 2024.

Scott: Stronger commercial execution drove sequential quarterly growth beginning in the second quarter of 2023.

Scott Dreyer: Our commercial accomplishments in 2023 position Belbuca for growth in 2024. Stronger commercial execution drove sequential quarterly growth beginning in the second quarter of 2023. We expect Bell Buick to benefit from improved commercial execution, the successful renegotiation of a major Medicare Part D contract, and the addition of a new Part D plan representing approximately 1 million covered lives.

We expect BELBUCA to benefit from improved commercial execution. The successful renegotiation of a major Medicare part D contract and the addition of a new part D plan, representing approximately 1 million covered lives.

Scott: Our focus in 2024 is on strengthening our commercial execution and supported BELBUCA, specifically investing in the knowledge and training of our field force pulling through BELBUCA strong commercial access and improving pushed through in Medicare part D.

Scott: Importantly, we will work on expanding Medicare part D coverage for BELBUCA, It's the right thing to do and if successful will serve as a catalyst for growth in 2025 and beyond.

Scott Dreyer: Our focus in 2024 is on strengthening our commercial execution in support of WQE, Specifically, investing in the knowledge and training of our field force, pulling through Bell Vuca's strong commercial access, and improving push-through in Medicare Part D. Importantly, we'll work on expanding Medicare Part D coverage for Bobucca. It's the right thing to do, and if successful, it will serve as a catalyst for growth in 2025 and beyond. Turning to Exstamsa ER, in 2023, we delivered record revenue driven by a significant gross to net improvement. Our successful contract renegotiations, with plans that accounted for 54% of extamsa-ER prescriptions in 2022, reduced gross to net by 9.7 percentage points, offsetting pressure on prescriptions.

Turning to extend CER in 2023, we delivered record revenue driven by significant gross to net improvement our successful contract renegotiations with plans that accounted for 54% of <unk> ER prescriptions in 2022 were Jewish gross to net by nine seven percentage points offsetting.

Scott: Pressure on prescriptions.

We expect a continuation of that dynamic in 2024 based off our successful renegotiation of contracts, representing 30% of all extends to ER prescriptions in 2023.

Scott: Our focus with <unk> in 2024 is on challenging the status quo with health care professionals.

Scott: <unk> ER has strong data in its label differentiating it from Oxycontin and it has superior access in both commercial and Medicare part D.

Our aspiration with <unk> to replace oxycontin utilization for appropriate patients in managed care, we need to pull through our strong excess positions in commercial and part D and importantly strive to achieve new wins, we have the ability to achieve new wins and forever manage gross to net to less than 65%.

Scott Dreyer: We expect a continuation of that dynamic in 2024, based on our successful renegotiation of contracts representing 30% of all Stamps to ER prescriptions in 2023. Our focus with EXTAMPSA-ER in 2024 will be challenging the status quo with healthcare professionals. EXAMPSE-ER has strong data in its label differentiating it from OxyContin, and it has superior access in both commercial and Medicare Part D. Our aspiration with EXTAMPSE-ER is to replace doxycontin utilization in appropriate patients.

Scott: The NUCYNTA franchise is a key contributor to our pain portfolio. It depends at all is a differentiated molecule with a proposed dual mechanism of action, it's viewed favorably and as highly differentiated by health care professionals, our market access strategy enables us to manage the NUCYNTA franchise contribution in a relatively stable manner.

Scott: Year on year, beginning in 2025 through loss of exclusivity.

Scott Dreyer: In managed care, we need to pull through our strong access positions in commercial and Part D and, importantly, strive to achieve new wins. We have the ability to achieve new wins and forever manage gross to net to less than 65%. The Nucinta franchise is a key contributor to our pain portfolio. Cepentadol is a differentiated molecule with a proposed dual mechanism of action.

Scott: In closing I'm proud of our commercial accomplishments in 2023 and focused on achieving our objectives in 2024 through operational execution I'll now turn the call back to Joe.

Joe: Scott 2023 was a banner year for Collegium pharmaceutical our accomplishments in 2023 position the organization for success in 2024 and bolster our outlook in 2025 and 2026, our focus in 2024 is on operational execution, we expect.

Scott Dreyer: It's viewed favorably and is highly differentiated by healthcare professionals. Our market access strategy enabled us to manage the Nucinta franchise contribution in a relatively stable manner, year on year, beginning in 2025 due to loss of exclusivity. In closing, I'm proud of our commercial accomplishments in 2023 and focused on achieving our objectives in 2024 through operational execution. I'll now turn the call back to Jeff.

Joe: To deliver record financial performance and we are committed to deploying capital to create long term value for our shareholders I will now open the call up for questions operator.

Speaker Change: At this time, we'll be conducting a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate that your line is in the question queue. You May press star two if he would like to remove your question from the queue. We ask that you limit your questions to one and a follow up so that others.

Joseph J. Ciaffoni: Thanks, Scott. 2023 was a banner year for Collegium Pharmaceutical. Our accomplishments in 2023 position the organization for success in 2024 and bolster our outlook for 2025 and 2026. Our focus in 2024 is on operational execution. We expect to deliver record financial performance, and we are committed to deploying capital to create long-term value for our shareholders. I will now open the call up for questions. Operator.

Speaker Change: May have an opportunity to ask questions for participants using speaker equipment. It may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.

Speaker Change: Okay.

Speaker Change: Our first question comes from David <unk> with Piper Sandler. Please proceed with your question.

David: Hey, thanks, so much.

David: One question on.

David: <unk> and then one on Biz Dev M&A.

David: On <unk>.

Operator: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question and answer session. You may press star 2 if you would like to remove your question from the queue.

Speaker Change: With the contract.

Speaker Change: Renegotiations, mostly in the in the rear view mirror I guess the question here is as you look.

Speaker Change: At the long term landscape for the product do you think that you can at some point return it to meaningful volume growth and then to the extent that you think you can talk through what kind of commercial efforts you were going to undertake to do so.

Operator: We ask that you limit your questions to one and a follow-up so that others may have an opportunity to ask questions. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button. One moment, please, while we poll for questions. Our first question comes from David Amsellem with Piper Sandler. Please proceed with your question. Hey, thanks.

Speaker Change: So that's number one and then on Biz Dev can you just talk through your latest thoughts on asset prices and the relative attractiveness of assets.

David A. Amsellem: So, one question on... Exstamza, and then one on BizDev M&A. On Exstamza, with the contract renegotiations mostly in the rearview mirror, I guess the question here is, as you look at the long-term landscape for the product, do you think that you can, at some point, return it to meaningful volume growth and then, to the extent that you think you can, talk through what kind of commercial efforts you're going to undertake to do so? So that's number one.

Speaker Change: They're out there what you're seeing in terms of the the landscape and I think in the past you've talked about being agnostic to.

Speaker Change: Various therapeutic verticals can you just talk to your latest thinking.

Speaker Change: Regarding debt. Thank you.

Speaker Change: Yeah.

Speaker Change: So David this is Joe. Thank you for the questions I'm going to start off on X stamps and then kick it over to Scott and then come back and address bid stuff.

Joe: First off with expanse. The thing that we are confident in is our ability to continue to grow revenue as we move forward through 2033.

Joseph J. Ciaffoni: And then on BizDev, can you just talk through your latest thoughts on asset prices and the relative attractiveness of assets that are out there, what you're seeing in terms of the landscape? And I think in the past, you've talked about being agnostic to various therapeutic verticals. Can you just talk through your latest thinking regarding that? Thank you.

Scott: With the asset where we're at now is it will be a year to year situation based off of what it is that we accomplish in the payer landscape. We now have significant headroom, where we're under so it would be under that 65% that we're forever committed to managing gross to net that gives us the ability to really.

Joseph J. Ciaffoni: Thank you for the questions. I'm gonna start off on Xtamsa and then kick it over to Scott and then come back and address BizDev. First off, with Xtamsa, the thing that we are confident in is our ability to continue to grow revenue as we move forward through 2033 with the asset. Where we're at now, it will be a year-to-year situation based on what it is that we accomplish in the payer landscape. We now have significant headroom where we're under to be under that 65% that we're forever committed to managing gross net. That gives us the ability to really go after and try to achieve new wins for the product. And then, of course, contracts come up for renegotiation typically every two to three years.

Scott: Go after and try to achieve new wins.

Scott: For the product and then of course contracts come up for renegotiation typically every two to three years. So theres fewer this year, but there will be new ones.

Scott: We move for where we think there will continue to be opportunity.

To manage gross to net and Scott can talk about some of the commercial efforts and things to make that happen. Yes. Thanks, David So first what I'd say is we have very strong access in commercial and part D for <unk> and what that means is first and foremost we can grow organically, there's plenty of room to still grow through pure execution.

Scott: As I mentioned in my prepared remarks, our focus is on displacing oxycontin for appropriate patients and how we do that is by challenging the status quo and so what we're doing is similar to what we've been doing for BELBUCA right training, our people practicing and showing up in front of the customer to change behavior and by doing that I am confident we have the ability to.

Joseph J. Ciaffoni: So there are fewer this year, but there will be new ones as we move forward where we think there will continue to be opportunities to manage gross net. And Scott can talk about some of the commercial efforts and things to make that happen. Yeah, thanks, David. So, first, what I'd say is that we have very strong access in commercial and Part D for extamsa. And what that means is, first and foremost, we can grow organically. There's plenty of room to still grow through pure execution.

Scott: Grow organically, where we have access and then we'll see as Joe said, what happens with the payer as we move forward.

Scott: And then David from a business development perspective.

David: What I think is important to emphasize is one our confidence in the financial strength of the business.

Scott Dreyer: As I mentioned in my prepared remarks, our focus is on displacing OxyContin for appropriate patients. And how we do that is by challenging the status quo. And so, what we're doing is similar to what we've been doing for Belbuca, right? Training our people, practicing, and showing up in front of the customer to change behavior.

David: We continue as we execute versus the core business and financially what we're setting out to do along with the improvement each quarter on the balance sheet to further strengthen our position and what that gives us is the ability to be clear headed from a BD perspective, so what I would comment specific.

Joseph J. Ciaffoni: And by doing that, I'm confident we have the ability to grow organically where we have access. And then we'll see, as Joe said, what happens with the payer as we move forward. And then, David, from a business development perspective, what I think is important to emphasize is, one, our confidence in the financial strength of the business. You know, we continue as we execute versus the core business and financially what we're setting out to do, along with the improvement each quarter on the balance sheet to further strengthen our position. And what that gives us is the ability to be clear-headed from a business development perspective.

To your question.

David: As look everything that we have been engaged with continues to be on the board.

David: We will wait for people to come to rational positions and when the value is there we continue to be in a strong position to strike.

David: And I'm confident we will get the right deal done FERC Collegium from a therapeutic perspective, we want to be agile because we think there are a significant number of opportunities out there and I'd reiterate what we're focused on our commercial stage acquisitions, only we want differentiated assets.

Joseph J. Ciaffoni: So what I would comment specific to your question is, look, everything that we have been engaged with continues to be on the table. We will wait for people to come to rational positions. And when the value is there, we continue to be in a strong position to strike, and I'm confident we will get the right deal done for Collegium. From a therapeutic perspective, we want to be agile because we think there are a significant number of opportunities out there.

David: We think that's critical for reimbursement of 150 million peak sales and exclusivity into the 20 <unk>.

Speaker Change: Okay. Thanks, Joe.

Speaker Change: Thank you.

Speaker Change: Our next question comes from Tim Lugo with William Blair. Please proceed with your question.

Speaker Change: Hey, guys. This is lachlan on for Tim Thanks for taking the questions and congrats on the strong quarter.

Joseph J. Ciaffoni: And I'd reiterate what we're focused on are commercial stage acquisitions only. We want differentiated assets. We think that's critical for reimbursement, 150 million peak sales, and exclusivity into the 2030s. Okay. Thanks, Joe.

Lachlan: First question is just wondering if we should expect any changes to discount that you all the cadence of discounts this year with it.

Lachlan: Medicare part D redesign.

Lachlan: And then second is given the shift to parity for a number of exams of contract in 2024 can.

Joseph J. Ciaffoni: Thank you. Our next question comes from Tim Lugo with William Blair. Please proceed with your question. Hey guys, it's Lachlan on for Tim.

Lachlan: Can you remind us sort of how prior parity contracts have performed and if there are any differences between the dynamics. So the timing of discounts or anything like that over the course of the year.

Operator: Thanks for taking the questions and congratulations on the strong quarter. The first question is just wondering if we should expect any changes to discounting or the cadence of discounts this year with Medicare Part D redesign. And secondly, given the shift to parity for a number of exams and contracts in 2024, can you remind us sort of how prior parity contracts have performed and if there are any differences between the dynamics or the timing of discounts or anything like that over the course of the year? Okay, thanks, Lachlan.

Lachlan: Okay. Thanks, Lachlan Colleen will take the discounting questions and then Scott will talk about.

Colleen: Our positioning within managed care and.

Colleen: And in answer to that question.

Colleen: Welcome and thanks for the question I would say as far as the cadence and the seasonality of discounting and gross to nets. Overall in 2024 will be relatively similar to what we've seen in prior years, which is you have the most favorable gross to net positions, particularly for our next dam subtype.

Colleen Tupper: Colleen will take the discounting questions, and then Scott will talk about our positioning within managed care and answer that question. Lachlan, thanks for the question. I would say as far as the cadence and the seasonality of discounting in gross-to-nets overall, in 2024, it will be relatively similar to what we've seen in prior years, which is you have the most favorable gross-to-net positions, particularly for an Examsa-type product in the first quarter, and then you have the impact of the coverage gap in the second and third quarters, or the donut hole, as it' And then Lachlan, so your question about parity positioning. So look, in parity, we've had one major parity position before now. And now we have a few more.

Colleen: Back in first quarter, and then you have the impact of coverage gap in second and third quarter are the donut hole as it's also known and then it bounces back in the fourth so we expect that to continue for another year in advance of any additional redesign in 2025.

Colleen: And then walk on to your question about parity positioning so look in parity we had one major priority position before now and now we have a few more and what we know is there's ample opportunity there to grow we have plenty of market share left to grow in those positions.

Colleen: And last one I would just add with regards to the renegotiations in general.

Colleen: We have maintained access we are not in parity positions and the only instances in which we are now at parity with Oxy cotton is generally where we've come off the formulary and I think from that perspective, the clinical profile of extent, so it's a differentiated asset and where is the <unk>.

Scott Dreyer: And what we know is that there's ample opportunity there to grow; we have plenty of market share left to grow in. Lachlan, I would just add, with regard to the renegotiations in general, where we have maintained access, we are not in parity positions, and the only instances in which we are now at parity with OxyContin are generally where we have come off the formulary. And I think from that perspective, the clinical profile of Exstansa is a differentiated asset, and we are, as the leader in responsible pain management, we are the only ones out there educating physicians on our product. Our next question comes from Serge Belanger with Needham & Co. Please proceed with your question. Hi, good afternoon, and thanks for taking my questions. First one, I guess, for Scott on Expamza. I think so far this year, we've seen about a 6% prescription erosion for extamsa. I'm curious if that's what you were expecting and if you expect those to come back. And then there is the second question. Joe

Colleen: And responsible pain management, we are the only ones out there educating physicians on our products.

Colleen: Our next question comes from Serge Belanger with Needham <unk> Co. Please proceed with your question.

Serge Belanger: Hi, good afternoon, and thanks for taking my questions.

Serge Belanger: First one I guess for Scott on <unk>.

Serge Belanger: I think so far this year, we've seen about a 6% prescription erosion for Forex stanza.

Serge Belanger: I'm curious if that's what you were expecting and if you expect to.

Serge Belanger: For those to come back.

Speaker Change: And then second question I guess for Joe.

Serge Belanger: Regarding BD, I think the BD transaction has been a priority for the company now for, since 2022. As your view or strategy around that priority evolved, Also, it's part of that question, I guess. In the past, you've talked about...

Speaker Change: Regarding BD.

Speaker Change: I think BD transactions has been a priority for the company now for.

Joe: Since 2022.

Joe: As you are.

Joe: Do you or strategy around that priority involved in.

Joe:

Speaker Change: So as part of that question I guess.

Speaker Change: In the past you've talked about.

Serge Belanger: Wanting to lever up for such a transaction. So also curious, with the recent share price appreciation, whether you would purchase via equity to complete a transaction. Thank you. Thanks, Serge. Scott, we'll take the first and then Colleen and I will share the second.

Speaker Change: Wanted to lever up for such a transaction.

Speaker Change: It's also curious with the recent share price appreciation, whether you would.

Speaker Change: Purchase.

Speaker Change: Your equity to <unk>.

Speaker Change: Completed transaction thanks.

Speaker Change: Yeah.

Speaker Change: Scott will take the first and then calling and I will share the second yeah. Thanks, Serge yes in simple terms yet.

Scott Dreyer: Yeah, thanks, Serge. Yeah, in simple terms, yeah, where the brand's performing right now is right in line with where we'd expect it to be. And similar to last year where we were removed, the greatest impact tends to be in the first quarter as we move on throughout the year.

Scott: The brand's performing right now is right in line with where we'd expect it to be and similar to last year, where we removed the greatest impact tends to be in the first quarter as we move throughout the year.

Scott Dreyer: And Serge, with regard to BD, what I would start with is capital deployment. What we're really focused on right now is what we know we're going to do, which is we're going to rapidly pay down our debt, and we will opportunistically leverage our share repurchase program. One of the things we take a lot of pride in is our track record of being really good stewards of capital and executing deals that make sense and deliver value for our shareholders. So as we continue to get stronger, what I can tell you is when the right deal is there at the right price, we are in a great position to execute. And Colleen can talk a little bit about how we think about the financial aspects. Yeah, so Serge, great question on the leverage side.

Speaker Change: And Serge with regards to BD.

Serge Belanger: What I would start with this capital deployment, what we're really focused on right. Now is what we know we're going to do which is we're going to rapidly pay down our debt and we will opportunistically leverage our share repurchase program. One of the things we take a lot of pride in is our track record of being really good stewards of capital and <unk>.

Serge Belanger: <unk> deals that makes sense and deliver value for our shareholders. So as we continue to get stronger what I can tell you is when the right deal was there at the right price. We are in a great position to execute and Colin can talk a little bit about how we think about the financial aspects.

Colin: Yeah. So search my question on the leverage side, what I would say is we have the ability to raise debt and are comfortable with our net debt ratio of around three times or below for commercial stage asset, which is what we're seeking in the current environment.

Colleen Tupper: What I would say is we have the ability to raise debt and are comfortable with a net debt ratio of around three times or below for commercial stage assets, which is what we're seeking in the current environment. I would also say, given our commercial focus, we are focused on near-term accretive and positive EBITDA. And, as noted, we also have the ability to use our equity if the market dynamics are supportive. So we think we have a multitude of options to fund the right deal when it comes along. Thank you. Thanks, Serge.

Colin: I would also say given our commercial focus we are focused on near term accretive and positive EBITDA and as noted we also have the ability to use our equity if the market dynamics are supportive. So we think we have a multitude of options there to find the right deal when it comes along.

Speaker Change: Thank you.

Speaker Change: Thanks Serge.

Colleen Tupper: Our next question... Our next question comes from Lej Sulewski with Truist. Please proceed with your question. Thank you, and congratulations on the quarter, guys.

Speaker Change: Our next question or.

Speaker Change: Our next question comes from Les Sulewski with Trust. Please proceed with your question.

Les Sulewski: Thank you and congrats on the quarter guys just to take another stab on the BD opportunity and you have mentioned in the past $150 million in peak potential sales.

Operator: Just to take another stab at the BD opportunity, you have mentioned in the past $150 million in peak potential sales. You know, maybe we can, is there the potential where you could see a few smaller deals versus a one-chunky one, or something that would be pre-approval in terms of an asset price? Yeah.

Les Sulewski: Maybe we can is there a potential where you could see a few smaller deals versus a one chunky one.

Joseph J. Ciaffoni: Thanks, Les. I appreciate the question. Well, from a BD perspective, I think what I would reiterate is everything that we have been focused on continues to be on the board. And I think they all fit the criteria of what it is that we're looking for.

Joseph J. Ciaffoni: Differentiated commercial stage assets, peak sales potential greater than $150 million with exclusivity into the 2030s. The one commentary I would make is that doesn't mean, like the deals we've done previously, they already need to be at $150 million. So we, for the right opportunity, if we have conviction that it can be $150 million plus, then we're in a great position to execute around that. And if one of the reasons why we're the better owner is because of the resources that we can bring to the table, we would go for that type of opportunity. I got it.

Les Sulewski: So for that type of opportunity.

Les Sulewski: Got it from my school you won't follow up on the capital deployment plans <unk> outside of repurchases [noise] have you specifically looked at.

Joseph J. Ciaffoni: And somebody squeezed in one follow-up. On the capital deployment plans, potentially outside of repurchases, have you specifically looked at a potential enactment of a dividend plan or any payout in the form of a one-time special dividend? Thank you. Les, I appreciate that question. I'm going to hand that one off to Colleen.

Les Sulewski: Potentially nachman there'll be dividend plan or any <unk> pay out of a form of a one time special dividend. Thank you.

Speaker Change: Yeah <unk> I appreciate that question I'm gonna handle that one off the calling yeah lastly, evaluate all options they'll be highly prefer to share repurchase program over again.

Colleen Tupper: Yeah, Les, we evaluate all options, but we highly prefer the share repurchase program over dividends. And you'll see that continue. Our next question comes from Oren Livnat with HC Wainwright. Please proceed with your question. Thanks for taking the questions. I have two.

Speaker Change: You can see that continue in the near future.

Speaker Change: Our next question comes from Orange <unk> with H C. Wainwright. Please proceed with your question.

Orange: Thanks for taking my questions.

Orange: To.

Operator: On Exstamsa, I find it interesting that you mentioned your large headroom now between, I guess, your 56 to 58 gross net guidance and, I guess, this theoretical ceiling that you want to maintain at 65. Can you talk about how big potential opportunities, you know, even if not exactly near term but the next couple of years, you might have to add volume opportunities that would still keep you all under that, because we obviously don't see the mix between, you know, Medicare plans, Medicaid, etc. You know, for example, something as gargantuan as the silver scripts, realistically on the table at a gross to net that would still keep you under that 65%. And I'm following them. So Oren, this is Joe.

Orange: <unk> kind of interesting that you mentioned your.

Orange: Large headroom now between I guess, you're 50, 658 cause sneck guidance and I guess, that's theoretical ceiling that you'd want to maintain a 65.

Speaker Change: Can you talk about.

Speaker Change: How big potential opportunities, even though even if not exactly near term, but the next couple of years you might have to add volume opportunities that would still keep you all under that because obviously don't see the mix between you know Medicare plan Medicaid et cetera, you know for example, something as gargantuan as a silver scripts realistically on the.

Speaker Change: Table that address to net that would still keep you under that 65 per cent and I'll follow up thanks.

Speaker Change: Mmm.

Speaker Change: This is Joe I appreciate that question well, one you're correct. We have a lot of head room to go out and win new plans. How that comes together year to year is something will provide an update on and you're also correct. If you think in Medicare part D.

Joseph J. Ciaffoni: I appreciate that question. Look, one, you're correct. We have a lot of headroom to go out and win new plans. How that comes together year to year is something we'll provide an update on. And you're also correct. If you think about Medicare Part D, there are some major plans that have significant amounts of oxycontin.

Speaker Change: There are some major plans that have significant oxy cotton and what I can tell you is if there's a path to getting that access that makes sense. Then we want to as a leader responsible pain management open that up for physicians and appropriate patients and then you can also look from a <unk>.

Joseph J. Ciaffoni: And what I can tell you is that if there's a path to getting that access that makes sense, then we want to, as a leader in responsible pain management, open that up for physicians and appropriate patients. And then you can also look from a commercial perspective where I'd say it's more a mile wide and an inch deep, but where you can piece together plans to position Exstamsa to continue to grow volume as we move forward. The key thing that I would emphasize in closing here is that we are confident in the ability, whether it be through the addition of new profitable contracts that would be a catalyst for volume, or as we continue to renegotiate contracts moving forward, that we'll be able to continue to grow Exstamsa ER revenue.

Speaker Change: Commercial perspective, where I'd say, it's more a mile wide and an inch deep, but where you can piece together plans to be up to position expand so to continue to grow volume as we move forward. The key thing that I would emphasize in closing here is what we are confident in is the ability whether it be through the <unk>.

Speaker Change: <unk> of new profitable contracts that would be a catalyst the volume <unk> as we continue to renegotiate contracts moving forward that will be able to continue to grow expanse of ER revenue, but now it will be more year to year. When we provide an update on how it is but that's going to happen.

Joseph J. Ciaffoni: But now it will be more year to year when we provide an update on how it is that that's going to happen. Okay. And on Belbuca, I guess now that that's your largest product and what appears to be our fastest growing product, which certainly reflects well on that acquisition, or the fruits of that acquisition. Can you talk a little bit longer term about how you view that? Because, you know, certainly I model, and I think the conservative or most conservative assumption is to assume that goes away in 2027. But now that that's such an important product for you, can you talk about your view on the longer runway for that, you know, potentially in 2027 and beyond, whether it's with regard to an existing settlement, patent wins, and the current litigation landscape? Thanks.

Speaker Change: Okay.

Speaker Change:

Speaker Change: And they'll buga I guess now that that's.

Speaker Change: <unk> your largest tronic N what appears to be our fastest growing product, which certainly reflects while on that acquisition for.

Speaker Change: To that acquisition can you talk a little bit longer term now how you do that cause you know.

Speaker Change: Certainly I model I think the conservative or most conservative assumption is just send that goes away in 2027, but now that that's such an important product for you can you can you talk about your view on the longer runway for that you know potentially in 2027 beyond whether it's with regards to an existing settlements patent when's and <unk>.

Speaker Change: Litigation landscape.

Speaker Change: Yeah. So appreciate the question or and look what what I can tell you. The number one is the BBSI acquisition for Collegium was an excellent deal and one that the team has done an exceptional job executing around I think Scott and his team deserve a tremendous amount of credit.

Joseph J. Ciaffoni: Yeah, so I appreciate the question, Oren. Look, what I can tell you, number one, is that the BDSI acquisition for Collegium was an excellent deal and one that the team has done an exceptional job executing around. I think Scott and his team deserve a tremendous amount of credit because one of the things that's most encouraging here at the start of the year is the prescription trends that we're seeing. So we really have a strong view that prescriptions will grow this year, and Belbuque is certainly a product that's worthy of that. From an IP perspective, what I would say to you is the following. In our base case when we did the BDSI acquisition, we assume a potential generic in 2027. That's because there's a settlement in place with Teva. What I would say there is Teva has relinquished its first filer exclusivity. They do not have a tentative approval yet.

Speaker Change: Because one of the things that's most encouraging here at the start of the year is the prescription trends that were saying.

Speaker Change: So we really have a strong view that will grow prescriptions. This year and BELBUCA certainly a product that's worthy of that from a I P perspective, what I would say to you is the following our base case when we did the BDSI acquisition is we assume a potential generic in 2027.

Speaker Change: Because there's a settlement in place with Taebo, what I would say there is Tampa has relinquish their first file or exclusively they do not have a tentative approval. The second and the filer was <unk> for us the green light to execute the deal was when Bts's.

Joseph J. Ciaffoni: The second and a filer was Albigen. For us, the green light to execute the deal was when BDSI received a favorable ruling with regard to the IP, which from an invalidity perspective bars Albigen from the market until 2032 with that formulation. And then, of course, Chemo is the third and a filer who attached itself to Albigen from an invalidity perspective. They are pursuing non-infringement, and I would just say that they received their third CRL in the first half of 2023. We think it is very challenging to achieve the doses of Belbuque or all doses without infringing upon the IP.

Speaker Change: I received a favorable rolling with regards to the I P, which from an invalidity perspective holds bars al Virgin from the market until 2032 with that formulation and then of course chemo is the third and a filer, who attach themselves to al <unk> from.

Speaker Change: Invalidity perspective, they are pursuing non infringement and I would just say that they received their third C. R. L. In the first half of 2023, we think it is very challenging to achieve the doses of BELBUCA are all doses without infringe.

Speaker Change: <unk> upon the I P. The final two points I would make is we have a authorized generic agreement with par pharmaceuticals, and probably the strongest common I could make with regards to our view of BELBUCA is we will continue to invest three 2027.

Joseph J. Ciaffoni: The final two points I would make are that we have an authorized generic agreement with PAR Pharmaceuticals and probably the strongest comment I could make with regard to our view of Belbuque is that we will continue to invest through 2027 in support of this asset because although our base case assumes generics, I think we need to see what happens and whether players do come to the market, in particular Teva. All right, thank you. Thank you. There are no further questions at this time. I would now like to turn the floor back over to Joe for a closing comment. Thank you, and thank you everyone for joining the call today. We look forward to updating you on our progress throughout the year. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. BF-WATCH TV 2021, www.collegiumpharmaceutical.com, The Bulletproof Executive, 2013

Speaker Change: In support of this asset because although our base case assumes generic I think we need to see what happens and whether you know players.

Speaker Change: Players to come to the market in particular.

Speaker Change: [noise] alright, thank you.

Speaker Change: Thank you.

Speaker Change: Yeah No further questions at this time I would now like to turn the floor back over to Joe's honey.

Speaker Change: Closing comments.

Joe: Thank you and thank you everyone for joining the call today, we look forward to updating you on our progress throughout the year.

Speaker Change: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

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