Q4 2025 Supernus Pharmaceuticals Inc Earnings Call

February 24, 2026

Peter Vozzo: Good afternoon. Welcome to Supernus Pharmaceuticals for the Quarter and Full Year 2025 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Instructions will follow at this time. As a reminder, this conference is being recorded. I would now like to hand the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Supernus Pharmaceuticals. You may now just begin.

Operator: Good afternoon. Welcome to Supernus Pharmaceuticals for the Quarter and Full Year 2025 Financial Results Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session. Instructions will follow at this time. As a reminder, this conference is being recorded. I would now like to hand the conference over to Peter Vozzo of ICR Healthcare, Investor Relations representative for Supernus Pharmaceuticals. You may now just begin.

Speaker #1: Later, we will conduct a question-and-answer session. Instructions will follow at this time. As a reminder, this conference is being recorded. I would now like to hand the conference over to Peter Vozzo of ICR Healthcare Investor Relations Representative for SUPERNUS Pharmaceuticals.

Speaker #1: You may now begin.

Speaker #2: Thank you, Antoine. Good afternoon to everyone and thank you for joining us today for SUPERNUS Pharmaceuticals' fourth quarter and full year 2025 financial results conference call.

Vijay: Thank you, Antoine. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' Q4 and full year 2025 Financial Results Conference Call. Today, after the close of market, the company issued a press release announcing these results. On the call with me today are Supernus' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec. This call is being made available via the investor relations section of the company's website at www.ir.supernus.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings.

Peter Vozzo: Thank you, Antoine. Good afternoon, everyone, and thank you for joining us today for Supernus Pharmaceuticals' Q4 and full year 2025 Financial Results Conference Call. Today, after the close of market, the company issued a press release announcing these results. On the call with me today are Supernus' Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec. This call is being made available via the investor relations section of the company's website at www.ir.supernus.com. During the course of this call, management may make certain forward-looking statements regarding future events and the company's future performance. These forward-looking statements reflect Supernus' current perspective on existing trends and information. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company's latest SEC filings.

Speaker #2: Today, after the close of market, companies should press release announcing these results. On the call with me today are SUPERNUS's Chief Executive Officer, Jack Khattar, and Chief Financial Officer, Tim Dec.

Speaker #2: Today's call is being made available via the Investor Relations section of the company's website at www.ir.supernus.com. During the course of this call, management may make certain forward-looking statements regarding the future events in the company's future performance.

Speaker #2: These forward-looking statements reflect SUPERNUS's current perspective on existing trends and information. Any such forward-looking statements are not guaranteed as future performance and involve risks and uncertainties, including those noted in the risk factors section of the company's latest S&P filings.

Vijay: Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on 24 February 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws. Now to the call with Vijay.

Peter Vozzo: Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held and recorded on 24 February 2026. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC. Supernus declines any obligation to update these forward-looking statements, except as required by applicable securities laws. Now to the call with Jack.

Speaker #2: After results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call is being held to record on February 24th, 2026.

Speaker #2: Since then, the company may have made additional announcements related to the topics discussed. Please reference the company's most recent press releases and current filings with the SEC.

Speaker #2: SUPERNUS declines any obligation to update these forward-looking statements, except as required by applicable securities laws. Announcing the call will be Jack.

Speaker #3: Thank you, Peter. SUPERNUS had a remarkable 2025, with significant progress made against our strategic objectives. The company achieved record total revenues of $719 million, delivered strong growth of 40% in revenues from our four growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained FDA approval of Anapco, and launched Anapco in the Parkinson's market.

Jack Khattar: Thank you, Peter Vozzo. Supernus had a remarkable 2025, with significant progress made against our strategic objectives. The company achieved a record total revenues of $719 million, delivered strong growth of 40% in revenues from our four growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained the FDA approval of Onapgo, and launched Onapgo in the Parkinson's market. Our financial performance in 2025 once again underscored our emphasis on growing our core business, despite the loss of exclusivity on both Trokendi XR and Oxtellar XR. With our four growth products, Qelbree, Gocovri, ZURZUVAE, and Onapgo, we have built a solid foundation for a new phase of accelerated growth for Supernus. During the Q4 of 2025, revenues from these four growth products accounted for approximately 76% of total revenues.

Jack Khattar: Thank you, Peter. Supernus had a remarkable 2025, with significant progress made against our strategic objectives. The company achieved a record total revenues of $719 million, delivered strong growth of 40% in revenues from our four growth products, successfully executed an integrated acquisition of Sage Therapeutics, obtained the FDA approval of Onapgo, and launched Onapgo in the Parkinson's market. Our financial performance in 2025 once again underscored our emphasis on growing our core business, despite the loss of exclusivity on both Trokendi XR and Oxtellar XR. With our four growth products, Qelbree, Gocovri, ZURZUVAE, and Onapgo, we have built a solid foundation for a new phase of accelerated growth for Supernus. During the Q4 of 2025, revenues from these four growth products accounted for approximately 76% of total revenues.

Speaker #3: Our financial performance in 2025 once again underscored our emphasis on growing our core business despite the loss of exclusivity on both Trukendi XR and Oxceler XR.

Speaker #3: With our four growth products, Kelbri, Procovery, Zerxuve, and Anapco, we have built a solid foundation for a new phase of accelerated growth for Supernus.

Speaker #3: During the fourth quarter of 2025, revenues from these four growth products accounted for approximately 76% of total revenues. Starting with Anapco during the fourth quarter of 2025, Anapco generated net sales of $8.9 million, up from $6.8 million in the third quarter of 2025.

Jack Khattar: Starting with Onpattro, during Q4 2025, Onpattro generated net sales of $8.9 million, up from $6.8 million in Q3 2025, and finished its first year on the market with $17.3 million in total net sales. Demand for the product continues to be healthy, despite the announced supply constraints, with more than 540 prescribers submitting over 1,800 enrollment forms since the launch of the product and through the end of January 2026. We have been focused on resolving the supply constraints that we discussed on our Q3 2025 earnings call. Progress with the current supplier has been made, allowing us to resume new patient initiation while continuing to service our existing Onpattro patients with maintenance therapy.

Speaker #3: And finished its first year on the market with $17.3 million in total net sales. Demand for the product continues to be healthy, despite the announced supply constraints, with more than 540 prescribers submitting over 1,800 enrollment forms since the launch of the product and through the end of January 2026.

Speaker #3: We have been focused on resolving the supply constraints that we discussed on our third quarter 2025 earnings call. Progress with the current supplier has been made allowing us to resume new patient initiation while continuing to service our existing Anapco patients with maintenance therapy.

Speaker #3: Our current outreach effort of verifying health benefits and coverage includes more than 700 patients, whose forms are currently in the queue for processing. In the fourth quarter of 2025, prescriptions grew by 29.6%, and the number of prescribers grew by 28% compared to the third quarter of 2025.

Jack Khattar: Our current outreach effort of verifying health benefits and coverage includes more than 700 patients whose forms are currently in the queue for processing. In the Q4 2025, prescriptions grew by 29.6%, and the number of prescribers grew by 28% compared to the Q3 2025. Switching now to ZURZUVAE, the brand had strong performance in 2025, with $32.8 million in collaboration revenues in the Q4 and $53 million for the 5-month period since the closing of the Sage acquisition on 31 July 2025. Full Q4 2025, US sales of ZURZUVAE, as reported by Biogen, increased approximately 187% compared to the same period in 2024 and approximately 19% compared to the Q3 2025.

Speaker #3: Switching now to Zerxuve, the brand has strong performance in 2025, with $32.8 million in collaboration revenues in the fourth quarter and $53 million for the five-month period since the closing of the Sage acquisition on July 31, 2025.

Speaker #3: For the full fourth quarter of 2025, US sales of Zerxuve as reported by Biogen increased approximately 187% compared to the same period in 2024 and approximately 19% compared to the third quarter of 2025.

Speaker #3: The number of prescribers in 2025 doubled compared to 2024, with more than 70% being repeat prescribers. Total prescriptions in 2025 increased by more than 150% compared to 2024.

Jack Khattar: The number of prescribers in 2025 doubled compared to 2024, with more than 70% being repeat prescribers. Total prescriptions in 2025 increased by more than 150% compared to 2024. Regarding Qelbree, the product had another year of robust performance, with 21% growth in total annual prescriptions in 2025 compared to 2024, and as reported by IQVIA. Qelbree exceeded $300 million in net sales for the year 2025, delivering 26% growth compared to 2024. In 2025, the brand delivered double-digit prescription growth of 29% and 18% in both the adult and pediatric patient populations, respectively.

Speaker #3: Regarding Kelbri, the product had another year of robust performance with 21% growth in total annual prescriptions in 2025 compared to 2024, as reported by IQVIA.

Speaker #3: Kelbri exceeded 300 million in net sales for the year 2025, delivering 26% growth compared to 2024. In 2025, the brand delivered double-digit prescription growth of 29% and 18% in both the adult and pediatric patient populations, respectively.

Speaker #3: For the fourth quarter of 2025, total prescriptions increased by 18% compared to the same period in 2024, while net sales increased by 9%. As net sales were impacted by an annual gross-to-net deduction, this was due to an unexpected bill of $4 million received from one of the PBMs covering the full year of 2025, which was fully reflected in the fourth quarter.

Jack Khattar: For the Q4 2025, total prescriptions increased by 18% compared to the same period in 2024, while net sales increased by 9%, as net sales were impacted by an annual gross-to-net deduction. This was due to an unexpected bill of $4 million received from one of the PBMs covering the full year of 2025 and which was fully reflected in the Q4. For full year 2025, gross-to-net for Qelbree ended up at approximately 49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50% to 55%. Switching now to Gocovri.

Speaker #3: For full year 2025, gross-to-net for Kelbri ended up at approximately $49%. Our expectation for 2026 continues to be consistent with our previously disclosed target of 50 to 55%.

Speaker #3: Switching now to Gocovri for full year 2025, net sales reached $146 million increasing by 12% compared to 2024 and total annual prescriptions reached an all-time high of approximately $67,000, growing by 14% compared to 2024.

Jack Khattar: For full year 2025, net sales reached $146 million, increasing by 12% compared to 2024. Total annual prescriptions reached an all-time high of approximately 67,000, growing by 14% compared to 2024. The brand finished 2025 with strong prescription growth of 16% in Q4 compared to the same period last year, with net sales of $38.6 million. Moving on to R&D, we initiated a follow-on Phase IIb randomized, double-blind, placebo-controlled trial with SPN-820, approximately 200 adults with major depressive disorder. This study will examine the safety and tolerability of SPN-820 and its efficacy at a dose of 2,400mg, given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy.

Speaker #3: The brand finished 2025 with strong prescription growth of 16% in the fourth quarter compared to the same period last year, and with net sales of $38.6 million.

Speaker #3: Moving on to our ND, we initiated a follow-on phase 2B randomized double-blind placebo-controlled trial with SPNA20 in approximately 200 adults with major depressive disorder.

Speaker #3: This study will examine the safety and tolerability of SPNA20 and its efficacy at a dose of 2,400 milligrams, given intermittently twice per week as an adjunctive treatment to the current baseline antidepressant therapy.

Jack Khattar: Our Phase IIb randomized, double-blind, placebo-controlled study of SPN-817 is ongoing, with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes 3 mg and 4 mg twice-daily doses. For our SPN-443 program, we expect to initiate a Phase I single ascending and multiple ascending dose study in adult healthy volunteers in the second half of this year. We have completed our evaluation of the early-stage pipeline assets from the Sage acquisition. As a result, we will retain certain assets for internal development, and we will be seeking partnerships for the remaining assets. Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates.

Speaker #3: Our Phase 2b randomized, double-blind, placebo-controlled study of SPN-817 is ongoing, with a targeted enrollment of approximately 258 adult patients with treatment-resistant focal seizures. This trial utilizes 3 milligram and 4 milligram twice-daily doses.

Speaker #3: And for our SPN-443 program, we expect to initiate a Phase 1 single-ascending and multiple-ascending dose study in adult healthy volunteers in the second half of this year.

Speaker #3: We have completed our evaluation of the early-stage pipeline assets from the Sage acquisition. As a result, we will retain certain assets for internal development and we will be seeking partnerships for the remaining assets.

Speaker #3: Finally, corporate development will continue to be a top priority for us as we look for additional strategic opportunities to further strengthen our future growth and leadership position in CNS through revenue-generating products or late-stage pipeline product candidates.

Speaker #3: With that, I will now turn the call over to Tim.

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

Speaker #4: Thank you, Jack. Good afternoon, everyone. As I review our fourth quarter and full year 2025 results, please refer to today's press release that was filed earlier today.

Tim Dec: Thank you, Jack. Good afternoon, everyone. As I review our Q4 and full year 2025 results, please refer to today's press release that was filed earlier today. We achieved record total revenue of $211.6 million for Q4 2025, an increase of 21% compared to the same quarter last year. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for Q4 2025 increased 34% compared to the same quarter last year. Total revenue in Q4 2025 was comprised of net product sales of $158.1 million, collaboration revenues associated with ZURZUVAE of $32.8 million, and royalty, licensing, and other revenues of $20.7 million.

Timothy Dec: Thank you, Jack. Good afternoon, everyone. As I review our Q4 and full year 2025 results, please refer to today's press release that was filed earlier today. We achieved record total revenue of $211.6 million for Q4 2025, an increase of 21% compared to the same quarter last year. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for Q4 2025 increased 34% compared to the same quarter last year. Total revenue in Q4 2025 was comprised of net product sales of $158.1 million, collaboration revenues associated with ZURZUVAE of $32.8 million, and royalty, licensing, and other revenues of $20.7 million.

Speaker #4: We achieved record total revenue of $211.6 million for the fourth quarter of 2025, an increase of 21% compared to the same quarter last year.

Speaker #4: Excluding net product sales of Trekendy XR and Oxtellar XR, total revenue for the fourth quarter of 2025 increased 34% compared to the same quarter last year.

Speaker #4: Total revenue in the fourth quarter of 2025 was comprised of net product sales of $158.1 million collaboration revenues associated with Zerxuve, of $32.8 million, and royalty licensing and other revenues of $20.7 million.

Speaker #4: This includes $15 million of licensing revenue recognized in the fourth quarter of 2025 related to the achievement of a regulatory milestone under our collaboration agreement with Shionogi.

Tim Dec: This includes $15 million of licensing revenue recognized in Q4 2025 related to the achievement of a regulatory milestone under our collaboration agreement with Shionogi. Please note, collaboration revenues represent approximately 50% of the sales of ZURZUVAE reported by Biogen. This increase was primarily due to the increase in net products sales of our growth products, Qelbree and Gocovri, as well as the addition of collaboration revenues from ZURZUVAE and from the launch of Onapgo in April 2025. For Q4 2025, combined R&D and SG&A expenses were $150.2 million, as compared to $108.1 million for the same quarter last year.

Timothy Dec: This includes $15 million of licensing revenue recognized in Q4 2025 related to the achievement of a regulatory milestone under our collaboration agreement with Shionogi. Please note, collaboration revenues represent approximately 50% of the sales of ZURZUVAE reported by Biogen. This increase was primarily due to the increase in net products sales of our growth products, Qelbree and Gocovri, as well as the addition of collaboration revenues from ZURZUVAE and from the launch of Onapgo in April 2025. For Q4 2025, combined R&D and SG&A expenses were $150.2 million, as compared to $108.1 million for the same quarter last year.

Speaker #4: Please note, collaboration revenues represent approximately 50% of the sales of Zerxuve, reported by Biogen. This increase was primarily due to the increase in net product sales of our growth products, Kelbri and Gocovri, as well as the addition of collaboration revenues from Zerxuve and from the launch of an APGO in April of 2025.

Speaker #4: For the fourth quarter of 2025, combined R&D and SGN expenses, were $150.2 million as compared to $108.1 million for the same quarter last year.

Tim Dec: Operating loss on a GAAP basis for Q4 2025 was $40 million, as compared to operating earnings of $21.4 million for the same quarter last year. The change was primarily due to higher Sage operating costs in Q4 2025 and incremental intangible asset amortization for ZURZUVAE and Onapgo. GAAP net loss was $4.1 million for Q4 2025, or a loss of $0.07 per diluted share, compared to GAAP net earnings of $15.3 million, or $0.27 per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings for Q4 2025 was $48.5 million, compared to $48.3 million in the same quarter of last year.

Timothy Dec: Operating loss on a GAAP basis for Q4 2025 was $40 million, as compared to operating earnings of $21.4 million for the same quarter last year. The change was primarily due to higher Sage operating costs in Q4 2025 and incremental intangible asset amortization for ZURZUVAE and Onapgo. GAAP net loss was $4.1 million for Q4 2025, or a loss of $0.07 per diluted share, compared to GAAP net earnings of $15.3 million, or $0.27 per diluted share in the same quarter last year. On a non-GAAP basis, which excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings for Q4 2025 was $48.5 million, compared to $48.3 million in the same quarter of last year.

Speaker #4: Operating loss on a gap basis for the fourth quarter of 2025 was $4 million. As compared to operating earnings of 21.4 million, for the same quarter last year.

Speaker #4: The change was primarily due to higher Sage operating costs in the fourth quarter of 2025 and incremental intangible asset amortization for Zerxuve and Annapco.

Speaker #4: GAAP net loss was $4.1 million for the fourth quarter of 2025, or a loss of $0.07 per diluted share, compared to GAAP net earnings of $15.3 million, or $0.27 per diluted share, in the same quarter last year.

Speaker #4: On a non-gap basis, which excludes amortization intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related cost, adjusted operating earnings for the fourth quarter of 2025 was $48.5 million, compared to $48.3 million in the same quarter of last year.

Speaker #4: Total revenues for the full year 2025 were a record $719 million. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the full year 2025 increased 27% compared to last year.

Tim Dec: Total revenues for the full year 2025 were a record $719 million. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the full year 2025 increased 27% compared to last year. Total revenues were comprised of net product sales of $626.6 million, ZURZUVAE-related collaboration revenues of $53 million, and royalty and licensing and other revenues of $39.4 million, including the aforementioned $15 million of licensing revenue received due to a regulatory milestone. During 2025, collaboration revenues represented sales reported by Sage since the close of the Sage acquisition on 31 July 2025. Combined R&D and SG&A expenses for the 12 months ended 31 December 2025 were $591.8 million, as compared to $430.4 million last year.

Timothy Dec: Total revenues for the full year 2025 were a record $719 million. Excluding net product sales of Trokendi XR and Oxtellar XR, total revenue for the full year 2025 increased 27% compared to last year. Total revenues were comprised of net product sales of $626.6 million, ZURZUVAE-related collaboration revenues of $53 million, and royalty and licensing and other revenues of $39.4 million, including the aforementioned $15 million of licensing revenue received due to a regulatory milestone. During 2025, collaboration revenues represented sales reported by Sage since the close of the Sage acquisition on 31 July 2025. Combined R&D and SG&A expenses for the 12 months ended 31 December 2025 were $591.8 million, as compared to $430.4 million last year.

Speaker #4: Total revenues were comprised of net product sales of $626.6 million, Zerxuve-related collaboration revenues of $53.0 million, and royalty, licensing, and other revenues of $39.4 million.

Speaker #4: Including the aforementioned $15 million of licensing revenue, received due to a regulatory milestone. During 2025, collaboration revenues represented sales reported by Saparis since the close of the Sage acquisition on July 31st, 2025.

Speaker #4: Combined R&D and SGNA expenses for the 12 months ended December 31st, 2025, were $591.8 million. As compared to $430.4 million last year. The change was primarily due to higher SGNA expenses including approximately $73 million of acquisition-related cost from the Sage acquisitions and approximately $50 million relating to Sage operating costs recorded since the closing of the acquisition.

Tim Dec: The change was primarily due to higher SG&A expenses, including approximately $73 million of acquisition-related costs from the Sage acquisitions and approximately $50 million related to Sage operating costs recorded since the closing of the acquisition. Operating loss on a GAAP basis for the full year 2025 was $62.3 million, as compared to operating earnings of $81.7 million for 2024. GAAP net loss was $38.6 million for the full year 2025, or a loss of $0.68 per diluted share, compared to a GAAP net earnings of $73.9 million, or $1.32 per diluted share in 2024.

Timothy Dec: The change was primarily due to higher SG&A expenses, including approximately $73 million of acquisition-related costs from the Sage acquisitions and approximately $50 million related to Sage operating costs recorded since the closing of the acquisition. Operating loss on a GAAP basis for the full year 2025 was $62.3 million, as compared to operating earnings of $81.7 million for 2024. GAAP net loss was $38.6 million for the full year 2025, or a loss of $0.68 per diluted share, compared to a GAAP net earnings of $73.9 million, or $1.32 per diluted share in 2024.

Speaker #4: Operating loss on a gap basis for the full year 2025 was $62.3 million, as compared to operating earnings of $81.7 million for 2024. Gap net loss was $38.6 million for the full year 2025, or a loss of $68.00 per diluted share.

Speaker #4: Compared to GAAP net earnings of $73.9 million, or $1.32 per diluted share in 2024. On a non-GAAP basis, which again excludes amortization of intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings were $158.7 million, compared to $183.7 million for last year.

Tim Dec: On a non-GAAP basis, which again excludes amortization of intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings were $158.7 million, compared to $183.7 million for last year. As of 31 December 2025, the company had approximately $309 million in cash equivalents, and marketable securities, compared to $454 million as of 31 December 2024. The decrease in our cash was primarily due to the funding of the Sage acquisition, offset by cash generated from operations. The company's balance sheet remains strong, with no debt and significant financial flexibility for potential M&A and other growth opportunities. Now turning to 2026 guidance.

Timothy Dec: On a non-GAAP basis, which again excludes amortization of intangibles, share-based compensation, contingent consideration, depreciation, and acquisition-related costs, adjusted operating earnings were $158.7 million, compared to $183.7 million for last year. As of 31 December 2025, the company had approximately $309 million in cash equivalents, and marketable securities, compared to $454 million as of 31 December 2024. The decrease in our cash was primarily due to the funding of the Sage acquisition, offset by cash generated from operations. The company's balance sheet remains strong, with no debt and significant financial flexibility for potential M&A and other growth opportunities. Now turning to 2026 guidance.

Speaker #4: As of December 31st, 2025, the company had approximately $309 million in cash, cash equivalents, and marketable securities. Compared to $454 million as of December 31st, 2024.

Speaker #4: The decrease in our cash was primarily due to the funding of the Sage acquisition, offset by cash generated from operations. The company's balance sheet remained strong, with no debt and significant financial flexibility for potential M&A and other growth opportunities.

Speaker #4: Now, turning to 2026 guidance. For the full year 2026, we expect total revenues to range from $840 million to $870 million, comprised of net product sales, Zerxuve collaboration revenues, and royalty and licensing revenues.

Tim Dec: For full year 2026, we expect total revenues to range from $840 million to $870 million, comprised of net product sales, ZURZUVAE collaboration revenues, and royalty and licensing revenues. Note, total revenue guidance for full year 2026 assumes approximately $45 million to $70 million of net sales from Onapgo. As Jack mentioned, new patient initiation for Onapgo began in the Q1 of this year. For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million to $650 million. Overall, we expect full year 2025 operating income loss in the range of break even to a loss of $30 million. Finally, we expect non-GAAP operating earnings to range from $140 million to $170 million.

Timothy Dec: For full year 2026, we expect total revenues to range from $840 million to $870 million, comprised of net product sales, ZURZUVAE collaboration revenues, and royalty and licensing revenues. Note, total revenue guidance for full year 2026 assumes approximately $45 million to $70 million of net sales from Onapgo. As Jack mentioned, new patient initiation for Onapgo began in the Q1 of this year. For the full year 2026, we expect combined R&D and SG&A expenses to range from $620 million to $650 million. Overall, we expect full year 2025 operating income loss in the range of break even to a loss of $30 million. Finally, we expect non-GAAP operating earnings to range from $140 million to $170 million.

Speaker #4: Note total revenue guidance for full year 2026 assumes approximately $45 million to $70 million of net sales from Annapco. As Jack mentioned, due patient initiation for Annapco began in the first quarter of this year.

Speaker #4: For the full year 2026, we expect combined R&D and SGNA expenses to range from $620 million to $650 million. Overall, we expect full year 2025 operating and the operating income loss in the range of break-even to a loss of $30 million.

Speaker #4: And finally, we expect non-GAAP operating earnings to range from $140 million to—please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP.

Tim Dec: Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back to the operator for Q&A. Operator?

Timothy Dec: Please refer to the earnings press release issued prior to this call that identifies the various ranges of reconciling items between GAAP and non-GAAP. With that, I will now turn the call back to the operator for Q&A. Operator?

Speaker #4: With that, I will now turn the call back to the operator for Q&A. Operator?

Speaker #1: Thank you. At this time, we will conduct the question-and-answer session. To ask a question, you will need to press star 11 on your telephone and wait for your name to be announced.

Peter Vozzo: Thank you. At this time, we will conduct a question-and-answer session. To ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while I compile the Q&A roster. Our first question comes from Andrew Tsai from Jefferies. Please go ahead.

Operator: Thank you. At this time, we will conduct a question-and-answer session. To ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while I compile the Q&A roster. Our first question comes from Andrew Tsai from Jefferies. Please go ahead.

Speaker #1: To withdraw your question, please press star 11 again. Please stand by while I compile the Q&A roster. Our first question comes from Andrew Tsai.

Speaker #1: From Jeffries, please go ahead.

Speaker #3: Hey, guys. This is John Cox on behalf of Andrew Tsai. Congrats on the quarter and thanks for taking my question. So just so we understand, the current supplier can supply $45 to $70 million of sales, and to get to that $70 million, can that be done by the current supplier, or does the high end require you to lock in the second supplier, or, say, earlier than 2027?

John Cox: Hey, guys. This is John Cox on behalf of Andrew Tsai. Congrats on the quarter and thanks for taking my question. Just so we understand, the current supplier can supply $45 to $70 million of sales, and to get to that $70 million, can that be done by the current supplier, or does the high end require you to lock in the second supplier, say, like, earlier than 2027?

Speaker #1: Yeah, for the current supplier, the plan is to get a supply through 2026. So certainly, that will cover us for the guidance that we gave.

Jack Khattar: Yeah, for the current supplier, the plan is to get us supplied through 2026. Certainly that will cover us for the guidance that we gave, you know, the $45 to $70 million. We expect the second supplier to provide us product in 2027. Now, regardless of when in 2027 the second supplier comes in, the current supplier will be there for us to be able to bridge, you know, to the second supplier. The plan is that we would have continuity of supply between the two suppliers, with the current one covering 2026, maybe a little bit in 2027, depending on when the new supplier comes online.

Speaker #1: You know, the $45 to $70 million. And then we expect the second supplier to provide us product in 2027. Now, regardless of when in 2027 the second supplier comes in, the current supplier will be there for us to be able to bridge, you know, to the second supplier.

Speaker #1: So the plan is that we will have continuity of supply between the two suppliers, with the current one covering 2026, maybe a little bit in 2027, depending on when the new supplier comes online.

Speaker #3: Okay, thanks. And then maybe one more if I can on Annapco. To get to that second supplier, what kind of data assuming non-clinical would ultimately be needed to obtain FDA approval?

John Cox: Okay, thanks. Then maybe one more, if I can, on Onapgo. To get to that second supplier, what kind of data, assuming non-clinical, would ultimately be needed to obtain FDA approval? Is that kind of the ultimate gating factor here? Thanks.

Speaker #3: Is that kind of the ultimate gating factor here? Thanks.

Speaker #1: Yes, typically, you know, you'll have to produce some batches at the new site or new supplier. You produce some stability data, you know, key basic data.

Jack Khattar: Yes. Typically, you know, you'll have to produce some batches at the new site or new supplier. You produce some stability data, you know, key basic data. You put a package together, submit it to the FDA. On an average, I mean, it could be 6 months review, 9 months review. We will get more clarity fairly soon, in the next month or so. Then based on that, we will expect the approval, hopefully. That's typically the timeline and the kind of package. The answer is yes, there will be no clinical, you know, study or data that you need to provide.

Speaker #1: You put a package together, submit it to the FDA. And on an average, I mean, it could be six months review, nine months review, we will get more clarity fairly soon in the next month or so.

Speaker #1: And then based on that, we will expect the approval, hopefully. So that's typically the timeline and the kind of package. So the answer is yes, there will be no clinical, you know, study or data that you need to provide.

Speaker #3: Great. Thanks so much. Congrats again.

John Cox: Great. Thanks so much. Congrats again.

Speaker #1: Thank you. Our next question comes from David Amsellem from Piper Sandler. Please go ahead.

Peter Vozzo: Thank you. Our next question comes from David Amsellem, from Piper Sandler. Please go ahead.

Operator: Thank you. Our next question comes from David Amsellem, from Piper Sandler. Please go ahead.

Tim Dec: Thanks. Two for me. First on Onapgo, and I apologize if I missed this. I just want to clarify. With the additional capacity, how much of underlying demand can you meet? Or maybe ask another way, can you fully clear the backlog, if you will, with the additional capacity that you now have in place? That's number one. Then secondly, regarding the R&D organization, with the integration of Sage, you mentioned you're taking on some early stage products and just wondering out loud...

Speaker #3: Thanks. So two for me. First, on Annapco, and I apologize if I missed this. I just want to clarify. So with the additional capacity, how much of underlying demand can you meet?

David Amsellem: Thanks. Two for me. First on Onapgo, and I apologize if I missed this. I just want to clarify. With the additional capacity, how much of underlying demand can you meet? Or maybe ask another way, can you fully clear the backlog, if you will, with the additional capacity that you now have in place? That's number one. Then secondly, regarding the R&D organization, with the integration of Sage, you mentioned you're taking on some early stage products and just wondering out loud...

Speaker #3: Or maybe, to ask another way: can you fully clear the backlog, if you will, with the additional capacity that you now have in place?

Speaker #3: So that's number one. And then R&D organization, with the integration of Sage, you mentioned you're taking on some early-stage products, and just wondering out loud, you know, how are you thinking about prioritizing those?

David Amsellem: ... you know, how you're thinking about prioritizing those, especially relative to your legacy pipeline assets, and when we might get some updates on what you're going to bring forward into the clinic there. Thank you.

Speaker #3: Especially relative to your legacy pipeline assets and when we might get some updates on what you're going to bring forward into the clinic there.

Speaker #3: Thank you.

Speaker #1: Yeah, regarding Annapco, the current supplier will certainly help us clear the backlog, you know, through the continuous supply that we will be able to have throughout 2026.

Jack Khattar: Yeah, regarding on APOKYN, the current supplier will certainly help us clear the backlog, you know, through the continuous supply that we will be able to have throughout 2026, and more than just the backlog, of course. Because we are initiating new patients, and not just with the current situation, meaning the 1,800 forms or 700 patients in the process, of course, that number will continue to be refilled during the year as we continue to grow the number of forms and so forth. We expect the current supplier to be able not only to clear the backlog, but also, of course, continue to provide for whatever needs we have throughout 2026 until we get, you know, the second supplier online.

Speaker #1: And more than just the backlog, of course. And because we are initiating new patients, not just with the current situation—meaning the 1,800 forms or 700 patients in the process—of course, that number will continue to be refilled during the year as we continue to grow the number of forms and so forth.

Speaker #1: So, we expect the current supplier to be able not only to clear the backlog, but also, of course, to continue to provide for whatever needs we have throughout 2026, until we get—you know—the second supplier online.

Jack Khattar: As far as the Sage R&D programs and so forth, I mean, these are really early stage assets. For now, we will be doing some, you know, early preclinical work, things like this, you know, to verify, you know, the activity, the mechanism of action, the selection of an indication and so forth. There will be a lot of preclinical type of work that has to be done on these assets. As far as prioritizing them within, you know, the portfolio that we have, we look at every product separately on its own merits, from a timing perspective, market opportunity, you know, ROI, and so forth. I mean, they will go through the same process of prioritization from a portfolio perspective.

Speaker #1: As far as the Sage R&D programs and so forth, I mean, these are really early-stage assets. So for now, we will be doing some, you know, early preclinical work, things like this, you know, to verify, you know, the activity, the mechanism of action, the selection of an indication, and so forth.

Speaker #1: So there will be a lot of preclinical type of work that has to be done on these assets. So as far as prioritizing them within the portfolio that we have, we look at every product separately on its own merits.

Speaker #1: From a timing perspective, market opportunity, you know, ROI and so forth. So I mean, they will go through the same process of prioritization from a portfolio perspective.

Speaker #3: Okay, thanks. And if I may just sneak in a follow-up, does that mean with the early-stage assets you have, and with your mid-stage assets in the pipeline, your BD focus is really more focused on market-ready and commercial-stage assets?

David Amsellem: Okay, thanks. If I may just sneak in a follow-up, does that mean with the early-stage assets you have and with your mid-stage assets in the pipeline, your BD focus is really more focused on market-ready and commercial stage assets? Is that a good way to think about it?

Speaker #3: Is that a good way to think about it?

Speaker #1: Yeah, that is correct. We are focused on revenue-generating, you know, situations—products on the market, and potentially late-stage pipeline assets. So, products that are in the pipeline that are at a later stage than our own pipeline.

Jack Khattar: Yeah, that is correct. We are focused on revenue-generating, you know, situations, products on the market, and potentially late-stage pipeline assets. Products that are in the pipeline that are at a later stage than our own pipeline, so they can get us to the marketplace or give us some other product launches somewhere, you know, between 2027 and 2030, 2031 timeframe. You know, that would be something that would be ideal for us.

Speaker #1: So they can get us to the marketplace or give us some other product launches somewhere, you know, between '27 and '30, '31 timeframe, you know, that would be something that will be ideal for us.

Speaker #3: All right. Thank you, Jack.

David Amsellem: All right. Thank you, Jack.

Peter Vozzo: Thank you. Our next question comes from Stacy Ku, from TD Cowen. Please go ahead.

Operator: Thank you. Our next question comes from Stacy Ku, from TD Cowen. Please go ahead.

Speaker #1: Thank you. Our next question comes from Stacy Ku, from TD Cowen. Please go ahead.

Speaker #4: Hey there. Thanks so much for taking our questions. Congratulations on an earnings a great earnings update and the Annapco supply update. So first, just as we think about the Annapco guidance for the year, and the patient demand that clearly all the analysts are trying to triangulate around, maybe first, could you talk about the learnings on the patient profile since launch?

Stacy Ku: Hey there. Thanks so much for taking our questions. Congratulations on an earnings, a good earnings update and the Onapgo supply update. First, just as we think about the Onapgo guidance for the year and the patient demand that clearly all the analysts are trying to triangulate around, maybe first, could you talk about the learnings on the patient profile since launch? Maybe talk about the frequency of use that you're seeing. What we're trying to understand, better understand, obviously, there's going to be a range, but how should we be thinking about the potential net pricing for a year of treatment? That's the first question.

Speaker #4: Maybe talk about the frequency of use that you're seeing. What we're trying to understand, better understand, obviously, there's going to be a range, but how should we be thinking about the potential net pricing for a year of treatment?

Speaker #4: So that's the first question. And then when it comes to the resumption of the new patient initiations for Annapco, should we be thinking about that 1,800 enrollment forms is reflecting a more limited writing from clinicians despite the supply disruption?

Stacy Ku: When it comes to the resumption of the new patient initiations for ONAPgo, should we be thinking about that 1,800 enrollment forms as reflecting a more limited writing from clinicians despite the supply disruption? Just a bit of a point of clarification for our second question. The third, as we're just, again, trying to understand the enrollment forms, as the sales force is going back to the clinicians and patients, what kind of dynamics are you seeing in terms of ONAPgo demand and statistics? Our understanding is that the behind the scenes, the commercial reimbursement and infrastructure was kind of continuing, even though we didn't know whether there's going to be a supplier or not. Happy to clarify the next question. Thanks.

Speaker #4: Just a bit of a point of clarification for our second question. And then the third, as we're just, again, trying to understand the enrollment forms, as the Salesforce is going back to the clinicians and patients, what kind of dynamics are you seeing in terms of Annapco demand and switches to Violet since our understanding is that behind the scenes, the commercial reimbursement and infrastructure was kind of continuing, even though we didn't know whether there's going to be supply or not?

Speaker #4: Happy to clarify the first question. Thanks.

Jack Khattar: Okay, hopefully, I'll get all of them. The first one, as far as the, you know, the profile of the patient, I mean, these are folks that are advanced in the disease. A lot of the oral medications are not enough anymore, so they continue to have, certainly a lot of episodes during the day, and they're not really well controlled, with levodopa/carbidopa and with any of the other adjunctive oral therapy that they're taking. Therefore, you know, in the physician's mind, they would be good candidates for the subcutaneous continuous, you know, infusion for something that is different than levodopa/carbidopa.

Speaker #1: Okay. Hopefully, I'll get all of them. I'll start with the first one. As far as the, you know, the profile, of the patient, I mean, these are folks that are advanced in the disease.

Speaker #1: A lot of the oral medications are not enough anymore. So they continue to have certainly a lot of episodes during the day. And they're not really well controlled.

Speaker #1: With double carbidopa and with any of the other adjunctive oral therapy that they're taking. And therefore, you know, they would be, in the physician's mind, they would be good candidates for subcutaneous, continuous infusion for something that is different than levodopa/carbidopa.

Jack Khattar: If that is the case, and that's what the physician is looking for, and therefore they would choose something like Onapgo apomorphine as a molecule, as a drug, you know, for that patient. As far as the potential, you know, moving forward and where the net pricing is gonna land, I mean, clearly the product has been on the market fairly short period of time, you know, only 8 months or 9 months. Certainly, that will, over time, you know, will calibrate depending on what we end up doing, if we do any contracting and so forth. But we talked historically about, you know, on an average, it's probably a 105, $100,000 per year on a WAC basis, you know, per patient.

Speaker #1: If that is the case and that's what the physician is looking for, and therefore they would choose something like Annapco, apomorphine as a molecule, as a drug, you know, for that patient.

Speaker #1: As far as the potential, you know, moving forward and where the net pricing is going to land, I mean, clearly the product has been on the market fairly short period of time, you know, on the eight months or nine months.

Speaker #1: Certainly, that will, over time, you know, calibrate depending on what we end up doing—if we do any contracting and so forth. But we thought, historically, about, you know, on average, it's probably $100,000 to $105,000 per year on a WACC basis.

Speaker #1: You know, per patient. Now, that certainly assumes a certain usage, which we're starting to get a better feel for. I don't have the data as much as I would like to before I, you know, say, you know, that's exactly how people are using the product and how frequently they're using it.

Jack Khattar: Now, that certainly assumes a certain usage, which we are starting to get a better feel for. I don't have the data as much as I would like to before I, you know, say, you know, that's exactly how people are using the product and how frequently they're using it. The 100,000 typically assumes about a cartridge a day, you know, give or take, you know, to get to that price or cost per year or per patient. The next question, I believe, was basically on the 1,800 forms and so forth. If I really understood the question, I mean, think about it, that's like a funnel, that's like a bucket of all the demand. That's why we try to give you this number, to give you an idea of what the demand is.

Speaker #1: But the $100,000 typically assumes about a cartridge a day, you know, give or take. You know, to get to that price or cost per year per patient.

Speaker #1: And then the next question, I believe, was basically on the 1,800 forms and so forth. If I really understood the question—I mean, think about it.

Speaker #1: That's like a funnel. That's like a bucket of all the demand. So that's why we try to give you this number, to give you an idea of what the demand is.

Speaker #1: And then clearly, as we process these forms, as eventually as patients get the shipments, eventually, you know, you're going to lose some forms or some patients on the way.

Jack Khattar: Clearly, as we process these forms, as eventually as patients get the shipments, eventually, you know, you're gonna lose some forms or some patients on the way. I mean, that's typical in any process, or any specialty type of product. Typically, that's what happens. You could lose certain patients in the process for many different reasons, as whether it's incomplete information, you can never finish the form or complete it. You'll be surprised sometimes how many phone calls you have to make, whether to the patient or to the doctor's office, to even complete the form so that you can start processing it. When the hub starts processing the form, and then doing the adjudication for insurance reimbursement, you could lose some patients there.

Speaker #1: I mean, that's typical in any process. Or any specialty type of product typically, that's what happens. And you could lose certain patients in the process for many different reasons as whether it's incomplete information, you can never finish the form or complete it, you'll be surprised.

Speaker #1: Sometimes, you have to make so many phone calls—whether to the patient or to the doctor's office—just to complete a form so that you can start processing it.

Speaker #1: And then when the hub starts processing the form, and then doing the adjudication for insurance, reimbursement, you could lose some patients there. And then, as time goes on, a patient may change their mind, or their situation might change—their medical situation.

Jack Khattar: As time goes on, a patient may change their mind or their situation might change, medical situation. For all these factors, clearly, you know, the 1,800 don't necessarily end up being 1,800 patients, at the end of the day. I don't know, what was it? I don't know if there is another question after that?

Speaker #1: So for all these factors, clearly, you know, the 1,800 don't necessarily end up being 1,800 patients at the end of the day. And I I don't know what was the I don't know if there is another question after that.

Stacy Ku: No, that's understood. I think we were hoping to hear whether or not more of these enrollment forms were being processed for reimbursement, while we're waiting for the supply to be replenished. Understood. Just one quick follow-up to your answer on the first net pricing piece, then. What kind of gross nets would you have expected for a specialty product?

Speaker #4: No, no. That's understood. I think we were hoping to hear whether or not more of these enrollment forms were being processed for reimbursement while we're waiting for the supply to be replenished.

Speaker #4: But understood. Just one quick follow-up to your answer on the first net pricing piece, then. What kind of grossness would you have expected for a specialty product?

Jack Khattar: For a product. I mean, we've been in this space. I mean, typically its range is somewhere between 20% and 30%, depending on the quarter, right? You know, Q1 is typically on the higher end, and then it decreases over time, and then the cycle starts again. I mean, that's typically the range, 20% to 30%. If I were to guess, it's a pure guess at this point, based on our experience in the category.

Speaker #1: I mean, for a product in I mean, we've been in this space. I mean, typically, it's a range of somewhere between 20 and 30 percent, depending on the quarter, right?

Speaker #1: Because you know, Q1 is typically on the higher end. And then it decreases over time. And then the cycle starts again. I mean, that's typically the range, 20 to 30 percent.

Speaker #1: If I were to guess, it's a pure guess at this point based on our experience in the category.

Speaker #4: Got it. And then last, if you may, if we could sneak one in on Calgary, just the Q1 dynamics. In light of the normal seasonality and maybe some of the one-time impacts this winter, just curious.

Stacy Ku: Got it. Last, if you, if you may, if we could sneak one in on Qelbree. Just the Q1 dynamics, in light of the normal seasonality and maybe some of the one-time impacts with Lindar, just curious how you all are thinking about the following quarter for Qelbree.

Speaker #4: How you all are thinking about the following quarter? For Calgary.

Jack Khattar: The seasonality on Qelbree?

Speaker #1: The seasonality on Calgary?

Jack Khattar: The seasonality on Qelbree?

Speaker #4: Correct. For Q1.

Stacy Ku: Correct, for Q1.

Jack Khattar: I mean, Q1, typically, it's not a seasonality because of school or anything. Typically, it's your typical seasonality from an insurance point of view. and that's not just Qelbree, I mean all products in general, because of the high deductibles that patients are facing. I mean, for the last couple years, I think we were more like flattish from a prescription or maybe went up a little bit. I mean, it's gonna fluctuate. I'm not saying that's exactly what will happen this quarter. I mean, you get some pressure. Now, we've also calibrate some of the co-pay business rules, so we can help patients as much as possible in Q1. We typically do that to offset some of that pressure. Sometimes we're pretty successful, and actually, prescriptions do grow nicely in Q1.

Speaker #1: I mean, Q1, typically, it's not a seasonality because of school or anything. Typically, it's your typical seasonality from an insurance point of view.

Speaker #1: And that's not just Calgary. I mean, all products in general because of the high deductibles that patients are facing. So I mean, for the last couple of years, I think we were more like flatish from a prescription or maybe went up a little bit.

Speaker #1: So I mean, it's going to fluctuate. I'm not saying that's exactly what will happen this quarter. But I mean, you get some pressure. Now, we also calibrate some of the copay business rules so we can help patients as much as possible in Q1.

Speaker #1: We typically do that to offset some of that pressure. So sometimes we're pretty successful, and actually, prescriptions do grow nicely in Q1. So we'll see where we land.

Jack Khattar: We'll see where we land, but nothing really unusual, I guess I'd have to say, versus previous years.

Speaker #1: But nothing really unusual I guess I have to say versus previous years.

Speaker #4: Okay. Incredibly helpful. Thank you so much.

Stacy Ku: Okay, incredibly helpful. Thank you so much.

Speaker #3: Thank you. Our next question comes from Kristen Kaluska from Cantor Fitzgerald. Please go ahead.

Peter Vozzo: Thank you. Our next question comes from Kristen Kluska, from Cantor Fitzgerald. Please go ahead.

Kristen Kluska: Hi, Jack and Tim. Congrats on a great quarter of revenues and progress here. On Enasco and the second supplier, I wanted to ask if you can provide a little bit more color about the profile of the supplier. For instance, if we see in 2027, 2028, that demand is continuing to outpace how you're thinking about it internally, are they gonna be the type of supplier that can be flexible and add more capacity for your product? You know, how important has that component been in your decision-making when it comes to who's gonna be best to supply this product?

Speaker #5: Hi, Jack and Tim. Congrats on a great quarter of revenues and progress here. On Annapco and the second supplier, I wanted to ask if you can provide a little bit more color about the profile of the supplier so for instance, if we see in 2027, 2028 that demand is continuing to outpace how you're thinking about it internally, are they going to be the type of supplier that can be flexible and add more capacity for your product?

Speaker #5: You know, how important has that component been in your decision-making when it comes to who's going to be best to supply this product?

Speaker #1: Yeah. The second supplier is actually our own partner in Europe, so they have their own manufacturing facility. And that's the same facility that produces product for the European market.

Jack Khattar: Yeah, the second supplier is actually our own partner in Europe. They have their own manufacturing facility, and that's the same facility that produces product for the European market. It's exactly the same product, and obviously they have significant experience in making the product. Capacity-wise, they have significant capacity, much larger capacity than the current supplier. We're also, I mean, have discussions with a third supplier. I mean, our plans obviously is, we're gonna secure the supply for the long term. This is not a just one-year situation. We wanna make sure that should the demand be as large as everybody is expecting, clearly we will have enough supply to meet that demand. That's really the plan that we have in place and we are executing on.

Speaker #1: So it's exactly the same product and obviously, they have significant experience in making the product. Capacity-wise, they have significant capacity, much larger capacity than the current supplier.

Speaker #1: And we're also I mean, I have discussions with a third supplier. So I mean, our plans obviously is we're going to secure the supply for the long term.

Speaker #1: This is not just one-year situation. We want to make sure that should the demand be as large as everybody is expecting, clearly, we will have enough supply to meet that demand.

Speaker #1: So that's really the plan that we have in place and we are executing on. And that's why we feel pretty confident, you know, to the extent we can, obviously, that the 2027, we should be really good with the second supplier and even beyond that.

Jack Khattar: That's why we feel pretty confident, you know, to the extent we can, obviously, that the 2027, we should be really good with the second supplier and even beyond that.

Speaker #5: Okay. Thanks. And you had mentioned earlier that you'll have more clarity in a month or so. Is that just on what you'll exactly need to show in terms of more process runs or any comparability stability data, excuse me, that you need to conduct prior to getting that approved on board?

Kristen Kluska: Okay, thanks. You had mentioned earlier that you'll have more clarity in a month or so. Is that just on what you'll exactly need to show in terms of more process runs or any comparability or stability data, excuse me, that you need to conduct prior to getting that approved on board? Is that my understanding?

Speaker #5: Is that my understanding?

Speaker #1: Yeah. I mean, in the next month or so, we will be having more communication with the FDA. So we will have more clarity on what are the different pieces. Again, the product is exactly the same product as is in the US, European, and US.

Jack Khattar: Yeah, I mean, in the next month or so, we will be having more communication with the FDA. We'll have more clarity what are the different pieces. Again, the product is exactly the same product as is in the US, European, and US. There are some differences in, like, specifications and things like this. From a production point of view, it's exactly the same product. We feel pretty good. Again, until we have that discussion, it will be difficult for us to know the exact timing and the extent of the package itself.

Speaker #1: There are some differences in specifications and things like this, but from a production point of view, it's exactly the same product. So we feel pretty good.

Speaker #1: But again, until we have that discussion, it will be difficult for us to know the exact timing and the extent of the package itself.

Speaker #5: Okay. And then at what point during this cycle are you going to be comfortable enough telling physicians? Hey, we're going to have more supply in X months from now so you can kind of get patients towards this therapy again.

Kristen Kluska: Okay. At what point during this cycle are you gonna be comfortable enough telling physicians, Hey, we're gonna have more supply in X months from now, so you can kind of get patients towards this therapy again? I know you've talked about the fact that this community has been really supportive of you for the fact that you've worked hard for these patients. You've had four drugs approved for this community. I'm just trying to understand at what point they can kind of give the patients the green light, that you don't have to wait much longer, a solution's coming.

Speaker #5: I know you've talked about the fact that this community has been really supportive of you for the fact that you've worked hard for these patients you've had for drugs approved for this community.

Speaker #5: So I'm just trying to understand at what point they can kind of give the patients the green light that you don't have to wait much longer, or a solution's coming.

Speaker #1: I mean, that in a way, it's now happening. Meaning, you know, we have already communicated to physicians that we are back to normal, so to speak.

Jack Khattar: I mean, that, in a way, it's now happening. Meaning, you know, we have already communicated to physicians that we are back to normal, so to speak. We will be processing forms, we will be initiating new patients, we will be sending shipments to patients. We want them to continue to, you know, submit forms as they have. I mean, it was really remarkable the support we gotten from the physician community. Last time we talked, we had 1,300 forms. Even despite the supply constraint, we were up to 1,800, you know, as I mentioned in my prepared remarks.

Speaker #1: We will be processing forms. We will be initiating new patients. We will be sending shipments to patients. So we want them to continue to, you know, submit forms as they have.

Speaker #1: I mean, it was really remarkable the support we got in from the physician community. Last time, we thought we had 1,300 forms even despite the supply constraint.

Speaker #1: We were up to 1,800, you know, as I mentioned in my prepared remarks. So the physicians continue to think of Annapco as a real treatment for a lot of the patients.

Jack Khattar: The physicians continue to think of APOKYN as a really real treatment for a lot of the patients and they're with us and, you know, they'll continue to, you know, serve their patients. We're pretty much at normal. Now, I can't say normal because we have to work through the backlog. I mean, you know, things don't happen, like, overnight, where overnight you're gonna initiate another 700 patients, right? It's gonna be over time that, given the capacity we have, you know, you have to think about nurses, initiations, all that. We will be able to provide, you know, a little bit more update later on, you know, by May, really. As far as keeping the demand and being able to serve our patients, we are in that position right now.

Speaker #1: And they're with us and, you know, they'll continue to, you know, serve their patients. So we're pretty much at normal. Now, I can't say normal, normal because we have to work through the backlog.

Speaker #1: So, I mean, you know, things don't happen overnight, where overnight you get to initiate another 700 patients, right? So it's going to be over time that, given the capacity we have—you know, you have to think about nurses, initiations, all that.

Speaker #1: So we will be able to provide, you know, a little bit more update later on, you know, by May clearly. But as far as keeping the demand and being able to serve our patients, we are in that position right now.

Speaker #5: Thanks, Jack. Glad to hear these are coming together.

Kristen Kluska: Thanks, Jack. Glad to hear these are coming together.

Speaker #3: Thank you. Our next question comes from Pavan Patel. From BOA, please go ahead.

Peter Vozzo: Thank you. Our next question comes from Pavan Patel from BofA. Please go ahead.

Operator: Thank you. Our next question comes from Pavan Patel from BofA. Please go ahead.

Pavan Patel: Hey, Jack and Tim. First, congrats on the supply constraint resolution. I think this is a best case scenario, so really happy for both you and the patients. I know our own survey work has shown that the demand for this product is really strong among both movement disorder specialists and patients. My first question is, as you work through initiating these 700 patients out of the queue, should we expect a temporary drag on Onapgo's gross nets in the first half of 2026? Will a significant portion of these patients require bridge supply or quick start programs while their benefits are being verified?

Speaker #6: Hey, Jack and Tim. So first, congrats on the supply constraint resolution. I think this is a best-case scenario. So really happy for both you and the patients.

Speaker #6: I know our own survey work has shown that the demand for this product is really strong among both movement disorder specialists and patients. So my first question is, as you work through initiating these 700 patients out of the queue, should we expect a temporary drag on Annapco's gross to nets in the first half of 2026?

Speaker #6: And will a significant portion of these patients require bridge supply or quick-start programs while their benefits are being verified? And then, I guess just like a modeling question, can you do more than $70 million with the supply that your current supplier is able to offer you?

Pavan Patel: I guess just like a modeling question, can you do more than $70 million with the supply that your current supplier is able to offer you, assuming that STADA and the second supplier are not online in 2026? Just maybe one on ZURZUVAE, since I think that's a topic worth hitting as well. I think the 70% repeat prescriber rate is pretty strong. Maybe as you plan your commercial efforts in 2026, are you shifting your focus towards driving deeper penetration volume among those existing repeat prescribers? Or is the priority gonna be start being to expand the absolute number of OB/GYNs and psychiatrists writing their first prescription? Thank you.

Speaker #6: Assuming that Stata and the second supplier are not online in 2026. And then just maybe one on Zorzube since I think that's a topic worth hitting as well.

Speaker #6: I think the 70% repeat prescriber rate is pretty strong. So maybe as you plan your commercial efforts in 2026, are you shifting your focus towards striving deeper penetration volume among those existing repeat prescribers, or is the priority going to be start being to expand the absolute number of OB/GYNs and psychiatrists writing their first prescription?

Speaker #6: Thank you.

Speaker #1: Yeah. Maybe I'll start with the last question. On Zorzube, clearly, I mean, we are still—and the way we think about it—we are still launching the product.

Jack Khattar: Yeah, maybe I'll start with the last question. On ZURZUVAE, clearly, I mean, and the way we think about it, we are still launching the product, you know. That's the mindset we always have with new products. Clearly, you're always launching, and as we mentioned earlier, I mean, this is a market that hasn't been really prepared a lot before the product was launched, because the initial indication was supposed to be MDD instead of PPD. Basically, the product was launched, and the market is being built at the same time. We still have a lot of work to do in building the market, education-wise. The brand actually enjoys a very high awareness, but we need to turn that awareness into action.

Speaker #1: You know, that's the mindset we always have. With new products, clearly, you're always launching. And as we mentioned earlier, I mean, this is a market that hasn't been really prepared a lot before the product was launched.

Speaker #1: Because the initial indication was supposed to be MDD instead of PPD. So, basically, the product was launched, and the market is being built at the same time.

Speaker #1: So we still have a lot of work to do in building the market. Education-wise, the brand actually enjoys a very, very high awareness, but we need to turn that awareness into action.

Jack Khattar: We need to turn that awareness into confidence for by physicians and to have the courage to actually screen, diagnose, and treat PPD. We will continue a lot of the great programs, you know, that Bausch and Sage have actually, you know, have started way back when they launched the product and into 2025. We'll continue a lot of these type of programs into 2026. Actually, this year, in 2026, and some people may have already seen the commercial, we have DPC efforts as well to educate as well the consumer and make more and more women and mothers, you know, comfortable in talking about their condition and come forward and seek treatment, because there is treatment, and they can really feel much better.

Speaker #1: We need to turn that awareness into confidence by physicians. And to have the courage to actually screen, diagnose, and treat PPD. So we will continue a lot of the great programs, you know, that Biogen and Sage had actually had started way back when they launched the product and into 2025.

Speaker #1: We'll continue a lot of these type of programs into 2026. And actually, this year in 2026, and some people may have already seen the commercial, we have DTC efforts as well to educate as well the consumer and make more and more women and mothers, you know, comfortable in talking about their condition and come forward and seek treatment.

Speaker #1: Because there is treatment, and they can really feel much better after taking a product that is only a 14-day treatment. And not waiting too long for it to actually kick in within only within day three.

Jack Khattar: after taking a product that is only a 14-day treatment and not waiting too long for it to actually kick in only within day three. A lot of activity behind ZURZUVAE because we're only scratching the surface at this point as far as the potential of this product. I mean, launch to date, we treated around 20,000+ patients. That's it. As some of you probably recall, you know, every year you have 500,000 women who actually experience symptoms of PPD, and only about half of them get diagnosed, and then 60% to 70% of those are treated. There's a lot of people there who need help, and where ZURZUVAE can really help them pretty well.

Speaker #1: So, a lot of activity behind Zorzube because we're only scratching the surface at this point as far as the potential of this product. I mean, launch to date, we've treated around 20,000-plus patients.

Speaker #1: That's it. And as some of you probably recall, you know, every year, you have 500,000 women who actually experience symptoms of PPD. And only about half of them get diagnosed, and then 60% to 70% of those are treated.

Speaker #1: So there is a lot of people there who need help. And where Zorzube can really help them pretty well. As far as current prescribers or new prescribers, I mean, like every other product, when it's still early in the launch, you're certainly getting a lot of new prescribers clearly.

Jack Khattar: As far as current prescribers or new prescribers, I mean, like every other product, when it's still early in the launch, you're certainly getting a lot of new prescribers, clearly. You know, from a reach perspective, and also as time goes on, you can have more frequency on these physicians. Those prescribers who are current prescribers, actually, the data shows us that 70% of the prescribers are repeat writers. We are getting a lot of business from the current prescribers. That speaks for, of course, also the high satisfaction level with the product and how it's performing.

Speaker #1: You know, from a reach perspective, and also as time goes on, you can have more frequency on these physicians. And certainly, those prescribers who are current prescribers actually, the data shows us that 70% of the prescribers are repeat writers.

Speaker #1: So clearly, we are getting a lot of business from the current prescribers. That speaks for, of course, also the high satisfaction level with the product and how it's performing you know.

Jack Khattar: Once a physician actually takes that first step and has the confidence, the conviction, and the courage to diagnose and treat, once they see the result from the first patient, they tend to be repeat writers, that's really very encouraging, you know, for the product at this stage. Moving on to Onapgo. Could we do more than $70 million? That is always potential, you know. That is also could happen. I don't know right now, but everything we have today, all the information we have as far as demand and everything, you know, got us to the point where we believe the range is really $45 to $70 million. Could it be that we could go above $70 million? I truly don't know right now.

Speaker #1: So once the physician actually takes that first step and has the confidence, the conviction, and the courage to diagnose and treat, and once they see the result from the first patient, they tend to be repeat writers.

Speaker #1: And that's really very encouraging, you know, for the product at this stage. Moving on to Annapco, I mean, could we do more than 70 million?

Speaker #1: That is always potential, you know, I mean, that is also a could happen. I don't know right now, but everything we have today, all the information we have as far as demand and everything, you know, got us to the point where we believe the range is really 45 to 70 million.

Speaker #1: Could it be that we could go above 70 million? I truly don't know right now. Otherwise, we would have had a higher end if we had, you know, comfort that we could go above that.

Jack Khattar: Otherwise, we would have had a higher end if we had, you know, comfort that we could go above that. We feel pretty good right now where we stand on Onpikko and the supply situation, and the guidance that we gave is really to help folks to see where the goalposts are on both ends.

Speaker #1: So we feel pretty good right now where we stand on Annapco and the supply situation. And that's so the guidance that we gave is really to help folks to see where the goalposts are on both ends.

Speaker #5: Thanks, Jack. And then just on the gross-to-nets, in the first half of '26, do you think that—

Pavan Patel: Thanks, Jack. Then just on the gross nets in the first half of 2026.

Jack Khattar: I'm sorry, on what?

Speaker #1: I'm sorry.

Pavan Patel: Gross nets.

Speaker #5: Gross to nets?

Jack Khattar: On APOKYN? Yeah, I mean, for APOKYN, on the gross-to-net, as I mentioned earlier, I mean, it's probably gonna be somewhere in the 20% to 30%. Again, higher in Q1, typically, and lower, you know, as the year goes on, because typically Q1, you're gonna have more incentives and things that will pressure the gross-to-net.

Speaker #1: For Annapco? Yeah. I mean, for Annapco and the gross-to-nets, as I mentioned earlier, I mean, it's probably going to be somewhere in the 20% to 30% range.

Speaker #1: Again, higher in Q1 typically, and lower as the year goes on. Because typically, Q1, you're going to have more incentives and things that will pressure the gross to net.

Speaker #5: Thank you.

Pavan Patel: Thank you.

Speaker #1: Thank you.

Jack Khattar: Thank you.

Speaker #6: Thank you. Our next question comes from Annabelle Saminy. From STIFL, please go ahead.

Peter Vozzo: Thank you. Our next question comes from Annabel Samimy from Stifel. Please go ahead.

Jack: Hi, this is Jack on for Annabel. Thanks for taking our questions. Congrats again on the quarter. Just quickly on the, for the CNS pipeline products for A17 and A20, do you have anything you can give us on the pace of enrollment there for either trial? When we might be expecting top-line data? On BD, are there any particular areas of focus you're looking at for new products? I know you've mentioned previously possibly broadening scope outside of CNS, potentially expanding into other areas like in women's health, now that you have ZURZUVAE. Have those priorities changed at all? Are you looking more at standalone specialty commercial products or small portfolios of assets?

[Analyst] (Stifel): Hi, this is Jack on for Annabel. Thanks for taking our questions. Congrats again on the quarter. Just quickly on the, for the CNS pipeline products for A17 and A20, do you have anything you can give us on the pace of enrollment there for either trial? When we might be expecting top-line data? On BD, are there any particular areas of focus you're looking at for new products? I know you've mentioned previously possibly broadening scope outside of CNS, potentially expanding into other areas like in women's health, now that you have ZURZUVAE. Have those priorities changed at all? Are you looking more at standalone specialty commercial products or small portfolios of assets?

Speaker #7: Hi. This is Jack on for Annabelle. . Thanks for taking our questions and congrats again on the quarter. Just quickly on the for the CNS pipeline products for 8/17 and 8/20, did you have anything you can give us on the pace of enrollment there for either trial and when we might be expecting top-line data?

Speaker #7: And then on BD, are there any particular areas of focus you're looking at for new products? I know you've mentioned previously possibly broadening scope outside of CNS.

Speaker #7: Potentially expanding into other areas like in women's health, now that you have Zorzube. Have those priorities changed at all? And are you looking more at standalone specialty commercial products or small portfolios of assets?

Speaker #1: Yeah. Regarding the CNS, you know, the pipeline on 8/17 and 8/20—I mean, 8/20, we just basically initiated the trial. So that's the earliest as far as enrollment.

Jack Khattar: Yeah, regarding the CNS, you know, the pipeline on A17 and A20. I mean, A20, we just basically initiated the trial, so that's still early as far as enrollment, but you would expect an MDD trial to recruit much quicker than typically an epilepsy trial. For A20 and A17, both trials, we're looking at data sometime in 2027. It's not gonna be this year. Hopefully, as time goes on, we'll have a much better trajectory, specifically on A17, because epilepsy trials tend to be much slower from a recruitment point of view. Also, you know, these are multicenter trials, specifically the one in A17, which is also geographically extends beyond the US. Typically, those are also, you know, could potentially be slower. But data is not gonna be any time before, you know, 2027.

Speaker #1: But you would expect an MDD trial to recruit much quicker than, typically, an epilepsy trial. So, for 8/20 and 8/17, both trials, we're looking at data sometime in 2027.

Speaker #1: It's not going to be this year. Hopefully, as time goes on, we'll have a much better trajectory, specifically on 8/17, because epilepsy trials tend to be much slower from a recruitment point of view.

Speaker #1: And also, you know, these are multicenter trials, specifically the one in 8/17, which is also geographically extends beyond the US. So typically, those are also could potentially be slower.

Speaker #1: So but data is not going to be any time before 2027. As time goes on, maybe in May or August this year, we'll be able to give you a better feel as it first half, second half, you know, first quarter, fourth quarter, whatever.

Jack Khattar: As time goes on, maybe in May or August this year, we'll be able to give you a better feel. Is it first half, second half, you know, Q1, Q4, whatever. We'll update folks as time goes on. As far as BD, absolutely. I mean, our focus has been CNS, will continue to be CNS, and we're agnostic whether that's neurology or psychiatry. Yes, we did say historically that we are willing to go outside CNS, and obviously, the Sage acquisition in a way, you know, overlapped on both. It is a CNS product, but it got us into women's health. Clearly that's an area we are looking at right now. Our priorities will continue to be revenue-generating, cash flow-generating opportunities....

Speaker #1: We'll update folks as time goes on. As far as BD, absolutely. I mean, our focus has been CNS. We continue to be CNS, and we're agnostic whether that's neurology or psychiatry.

Speaker #1: And yes, we did say historically that we are willing to go outside CNS. And obviously, the Sage acquisition, in a way, you know, overlapped on both.

Speaker #1: It is a CNS product, but it got us into women's health. So clearly, that's an area we are looking at right now. And our priorities will continue to be revenue-generating, cash-flow-generating opportunities, and if there are any assets there that are pipeline assets, our preference would be more on later-stage assets.

Jack Khattar: If there are any assets there that are pipeline assets, our preference would be more on later stage assets. Again, that could potentially give us the new product launches in the, you know, 2027 to 2030, 2031 timeframe. That's really the prioritization that we have and what we're working towards from that perspective. As Tim said, you know, we have a nice clean balance sheet, we have flexibility on whether, you know, the transaction is a product, is it a company, is it a portfolio of products? I mean, that gives us some flexibility there, obviously.

Speaker #1: Again, that could potentially give us a new product launches in the 27 to 2030, 2031 timeframe. So that's really the prioritization that we have, and what we're working towards.

Speaker #1: From that perspective. And as Tim said, you know, we have a nice clean balance sheet. So we have flexibility on whether, you know, the transaction is a product, is it a company, is it a portfolio of products.

Speaker #1: So, I mean, that gives us some flexibility there, obviously.

Speaker #5: Great. Thanks so much.

Jack: Great. Thanks so much.

[Analyst] (Stifel): Great. Thanks so much.

Speaker #6: Thank you. This concludes the question and answer session. I will now turn it back to Jack Khattar, for closing remarks.

Peter Vozzo: Thank you. This concludes the question and answer session. I will now turn it back to Jack Khattar for closing remarks.

Operator: Thank you. This concludes the question and answer session. I will now turn it back to Jack Khattar for closing remarks.

Speaker #1: Thank you for joining us on this call today, 2025, with a special year for SUPERNUS. It marked our 20th year anniversary, and the completion of our successful transition from our legacy products to candy XR and OXTELLA XR.

Jack Khattar: Thank you for joining us on this call today. 2025 was a special year for Supernus. It marked our 20th year anniversary and the completion of our successful transition from our legacy products to Trokendi XR and Oxtellar XR. In 2025, Supernus delivered one of its best performances ever, with record revenues of $719 million behind the robust performance of its growth portfolio, consisting of Qelbree, Lokahi, Zurzuvae, and APOKYN. Supernus has now a diversified portfolio of growth products, where our future success is not solely dependent on one single product. We expect to see continued healthy growth from Qelbree and Lokahi, augmented by significant growth from Zurzuvae and APOKYN, two products that have been on the market for two years or less and have a significant market opportunity.

Speaker #1: In 2025, SUPERNUS delivered one of its best performances ever, with record revenues of $719 million, behind the robust performance of its growth portfolio, consisting of Kelbri, Gokabri, Zorzube, and Annapco.

Speaker #1: SUPERNUS has now a diversified portfolio of growth products, where our future success is not solely dependent on one single product. We expect to see continued healthy growth from Kelbri and Gokabri, augmented by significant growth from Zorzube and Annapco.

Speaker #1: Two products that have been on the market for two years or less and have a significant market opportunity. In addition to our four growth products, we continue to advance our pipeline.

Jack Khattar: In addition to our four growth products, we continue to advance our pipeline and to explore corporate development opportunities to position Supernus as a long-term growth company, while generating, at the same time, strong cash flows behind the strength of our expanded product portfolio and through the efficiency of our operations. Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.

Speaker #1: And to explore corporate development opportunities to position SUPERNUS as a long-term growth company, while generating at the same time strong cash flows behind the strength of our expanded product portfolio and through the efficiency of our operations.

Speaker #1: Thanks again for joining us this afternoon. We look forward to providing you with updates throughout the year.

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

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

Q4 2025 Supernus Pharmaceuticals Inc Earnings Call

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