Q4 2024 Lantheus Holdings Inc Earnings Call

Recorded and a replay will be available in the investors section of the company's website approximately two hours after the completion of the call.

Speaker Change: The archived for at least 30 days I'll now turn the call over to Mark Qunar knee, Vice President of Investor Relations Mark.

Speaker Change: Thank you good morning with me today are Brian Marcussen, our CEO, Paul Blanchfield, our President Bob Marshall, Our CFO and Amanda Morgan, our Chief Commercial officer, we will begin with prepared remarks, and then open the call for Q&A.

Speaker Change: This morning, we issued a press release, which was furnished to the SEC under form 8-K reporting our fourth quarter 2024 results.

Speaker Change: The release and today's slide presentation or in the investors section of our website.

Speaker Change: Any comments made could include forward looking statements actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings.

[music].

Speaker Change: Discussions will also include certain non-GAAP financial measures reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investors section of our website.

Brian Marcussen: I'll now turn the call over to our CEO, Brian <unk>.

Brian Marcussen: Thank you Mark and good morning, everyone.

Brian Marcussen: 2024 was a groundbreaking year for <unk> as we achieved a number of important milestones and enhanced our capabilities as the leading radiopharmaceutical focused company.

Brian Marcussen: I am immensely proud of our team and the meaningful difference we have made in the lives of over 7 million patients in 2024.

Brian Marcussen: Our strong performance in the fourth quarter and throughout all of 2024.

Okay.

Brian Marcussen: Was driven by our commitment to operational excellence we remain.

Speaker Change: Good morning, welcome to the land this fourth quarter and full year 2024 conference call. All lines have been placed on mute. This call is being recorded and a replay will be available in the investors section of the company's website approximately two hours after the completion of the call.

Brian Marcussen: <unk> focused on further expanding our radiopharmaceutical excellence through a leading commercial portfolio innovative pipeline and differentiated capabilities.

Brian Marcussen: Last month, we announced two strategic transactions that have the potential to first enhance our capabilities across the radiopharmaceutical value chain <unk>.

Mark: Be archived for at least 30 days I'll now turn the call over to Mark <unk>, Vice President of Investor Relations Mark.

Brian Marcussen: <unk> in all timers diagnostics and oncology therapeutics.

Brian Marcussen: Second allow us to enter new markets with significant growth potential that diversify our business.

Speaker Change: Thank you good morning, with me today are Brian Marcus and our CEO, Paul Blanchfield, our President Bob Marshall, Our CFO and Amanda Morgan, our Chief commercial officer.

Brian Marcussen: Third expand our pipeline with potentially best or first in class radiopharmaceutical diagnostic players that make use of our existing expertise.

Speaker Change: We will begin with prepared remarks, and then open the call for Q&A.

This morning, we issued a press release, which was furnished to the SEC under form 8-K reporting our fourth quarter 2024 results.

And fourth helped to drive sustained double digit revenue growth beginning in 2026.

Speaker Change: The release and today's slide presentation or in the investors section of our website.

Brian Marcussen: Like molecular imaging will support our future growth with the addition of new receipt and approved radio diagnostic for all Simers disease expand our capabilities with an all time was commercial franchise as well as an enhanced R&D and clinical development capabilities and grow our pipeline.

Any comments made could include forward looking statements actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings.

Speaker Change: Discussions will also include certain non-GAAP financial measures reconciliation of these measures to the most directly comparable GAAP financial measures is included in the investors section of our website.

Brian Marcussen: Evergreen 30, Gnostics has the potential to add <unk> <unk>, a registrational stage pet radio diagnostics that complements our therapeutic registrational stage candidate PMT to zero-zero, three strengthen our clinical and commercial manufacturing capabilities and multiple clinical and <unk>.

Brian: I'll now turn the call over to our CEO, Brian <unk>.

Brian: Thank you Mark and good morning, everyone.

Speaker Change: 2024 was a groundbreaking year for <unk> as we achieved a number of important milestones and enhanced our capabilities as the leading radiopharmaceutical focused company.

Brian Marcussen: Preclinical assets to the pipeline.

Brian Marcussen: And enhance our early stage R&D capabilities quite significantly.

Speaker Change: I am immensely proud of our team and the meaningful difference we have made in the lives of over 7 million patients in 2024.

Brian Marcussen: Both acquisitions are subject to customary closing conditions and are expected to close in the second half of this year.

Speaker Change: Our strong performance in the fourth quarter and throughout all of 2024.

Brian Marcussen: Throughout 2024, we also executed a series of asset and licensing deals to expand our pipeline.

Speaker Change: Was driven by our commitment to operational excellence, we remain focused on further expanding our radiopharmaceutical excellence through a leading commercial portfolio innovative pipeline and differentiated capabilities.

Brian Marcussen: We are excited about these potentially best our first in class agents for Alzheimers disease, and oncology and plan to advance them during the year.

Speaker Change: Last month, we announced two strategic transactions that have the potential to first enhance our capabilities across the radiopharmaceutical value chain.

Brian Marcussen: Operationally, we grew clarify to over $1 billion in sales, making it the first ever radio diagnostic blockbuster and the clear number one utilized PSA pet imaging agent.

Speaker Change: Including in all timers diagnostics and oncology therapeutics.

Brian Marcussen: We also grew our market, leading ultrasound enhancing agent affinity double digits and its 24th year on the market.

Speaker Change: Second allow us to enter new markets with significant growth potential that diversify our business.

Speaker Change: Third expand our pipeline with potentially best or first in class radiopharmaceutical.

Brian Marcussen: In November CMS issued its calendar year, 2025 rule, which enhanced payment from specialized diagnostic radiopharmaceuticals recovered products.

Speaker Change: <unk> pairs that make use of our existing expertise.

Brian Marcussen: This was a significant step that will support long term radiopharmaceutical diagnostic innovation.

Speaker Change: And of course helped to drive sustained double digit revenue growth beginning in 2026.

Speaker Change: We entered 2025 focused on leading the Renaissance in Radiopharmaceuticals growing both our flagship diagnostic agents advancing our pipeline closing, our two recently announced transactions and delivering value to our patients customers employees and shareholders.

Speaker Change: Like molecular imaging will support our future growth with the addition of nursing and approved radio diagnostic for all silent disease expand our capabilities with an all time as commercial franchise as well as an enhanced R&D and clinical development capabilities and grow our pipeline.

Paul Blanchfield: With that I'll turn the call over to Paul to provide an update on our operational performance Paul.

Speaker Change: Evergreen theory, Gnostics has the potential to add activity, a registrational stage pet radio diagnostics that complements our therapeutic registrational stage candidate PNT zero-zero, three strengthen our clinical and commercial manufacturing capabilities and multiple clinical and <unk>.

Paul Blanchfield: Thank you Brian.

Speaker Change: I'm incredibly proud of our team's performance in 2024 and excited about the opportunities in front of us in 2025.

Speaker Change: With over $1 billion in sales Polaris <unk> remains the clear number one utilized PSM a pet imaging agent.

Speaker Change: Preclinical assets to the pipeline.

Speaker Change: We plan to build on this success by growing both volume and net sales in 2025 and are confident that we will maintain our market leadership and relative price premium even amidst competitive pressures.

Speaker Change: And enhance our early stage R&D capabilities quite significantly.

Speaker Change: Both acquisitions are subject to customary closing conditions and are expected to close in the second half of this year.

Speaker Change: Throughout 2024, we also executed a series of asset and then licensing deals to expand our pipeline.

Speaker Change: Polaris <unk> sales for the quarter were $266 million.

Speaker Change: Up 15, 7% year over year.

Speaker Change: We are excited about these potentially best our first in class agents for Alzheimers disease, and oncology and plan to advance them during the year.

Speaker Change: Growth was driven by volume and net price was up approximately 1% year over year, even after taking a mid single digit price increase at the beginning of 2024.

Speaker Change: Operationally, we grew clarify to over $1 billion in sales, making it the first ever radio diagnostic blockbuster and the clear number one utilized PSA pet imaging agent.

Speaker Change: Quarter over quarter, we grew volumes just shy of 2% with net price essentially flat.

Speaker Change: Fueling this growth is the continued expansion of the <unk> current addressable market, which we estimate to be $2 five plus billion dollars in 2025 up from two plus billion dollars in 2024, while the total addressable market could exceed $3 $5 billion by the end.

Speaker Change: We also grew our market, leading ultrasound enhancing agent affinity double digits and its 24th year on the market.

Speaker Change: In November CMS issued its calendar year, 2025 rule, which enhanced payment for specialized diagnostic radiopharmaceuticals recovery products.

Speaker Change: The decade.

Speaker Change: This was a significant step that will support long term radiopharmaceutical diagnostic innovation.

Speaker Change: Year over year market growth is expected to be driven by the continued conversion of bone scans in the initial staging and PCR patient segments, and we expect our customer base to grow their <unk> pet volumes accordingly, as the vast majority of our hospital and freestanding imaging business are now under long term.

Speaker Change: We enter 2025 focused on leading the Renaissance in Radiopharmaceuticals growing both our flagship diagnostic agents advancing our pipeline closing, our two recently announced transactions and delivering value to our patients customers employees and shareholders.

Speaker Change: Term strategic partnership agreements.

Speaker Change: We took an almost 6% WAC price increase earlier in 2025.

Paul: With that I'll turn the call over to Paul to provide an update on our operational performance.

And expect Polaris <unk> clinical and commercial differentiation to continue to support its clear market leadership and premium pricing.

Paul: Thank you Brian.

Paul: I'm incredibly proud of our team's performance in 2024 and excited about the opportunities in front of us in 2025.

Speaker Change: As Brian mentioned, we are pleased with CMS as new payment policy, which recognizes the value of and ensures access to innovative radio diagnostics.

Speaker Change: With over $1 billion in sales Polaris <unk> remains the clear number one utilized PSM a pet imaging agent.

Speaker Change: We plan to build on this success by growing both volume and net sales in 2025 and are confident that we will maintain our market leadership and relative price premium even amidst competitive pressures.

Speaker Change: The rule provides separate payment for innovative radiopharmaceutical diagnostics like Polaris high following expiry of transitional pass through payment status for the approximately 20% of patients with traditional Medicare fee for service insurance coverage, who are treated in the hospital outpatient setting.

Speaker Change: Polaris <unk> sales for the quarter were $266 million.

Paul: Up 15, 7% year over year.

Speaker Change: Clarify op PFS Medicare fee for service payment rates are in a significantly better position than they would have been absent cms's adoption of separate payment and we plan to continue to engage CMS as well as other stakeholders to establish a payment based on average sales price or ASP.

Speaker Change: Growth was driven by volume and net price was up approximately 1% year over year, even after taking a mid single digit price increase at the beginning of 2024.

Speaker Change: Quarter over quarter, we grew volumes just shy of 2% with net price essentially flat.

Speaker Change: <unk> has been reporting clarifies asps since launch and we believe other radiopharmaceutical diagnostics can as well, which would facilitate cms's ability to establish asps as the basis for separate payment in the future.

Speaker Change: Fueling this growth is the continued expansion of the PMA pet current addressable market, which we estimate to be $2 five plus billion dollars in 2025 up from two plus billion dollars in 2024, while the total addressable market could exceed $3 $5 billion by the end.

Speaker Change: More broadly we believe this rule represents significant progress for the long term potential and sustainability of our existing diagnostic pipeline, including MK 60 to $40 and now $46 94, as well as those agents that would be included in our recently announced strategic.

Speaker Change: The decade.

Speaker Change: Year over year market growth is expected to be driven by the continued conversion of bone scans in the initial staging and PCR patient segments, and we expect our customer base to grow their <unk> pet volumes accordingly, as the vast majority of our hospital and freestanding imaging business are now under long term.

Speaker Change: <unk>.

Speaker Change: We continue to invest in clarify, including assessing the benefits of PSNH imaging with <unk> in intermediate favorable patients via the mirror study, which continues to enroll as well as in <unk> expressing tumors beyond prostate through additional phase <unk> studies.

Speaker Change: Term strategic partnership agreements.

Speaker Change: We took an almost 6% WAC price increase earlier in 2025.

Speaker Change: And expect Polaris <unk> clinical and commercial differentiation to continue to support its clear market leadership and premium pricing.

Speaker Change: We look forward to sharing more about our progress throughout 2025.

Speaker Change: The affinity continues to be the number one utilized ultrasound enhancing agent delivering fourth quarter net sales of $86 2 million up.

Speaker Change: As Brian mentioned, we are pleased with CMS as new payment policy, which recognizes the value of and ensures access to innovative radio diagnostics.

Speaker Change: Up 17, 9% year over year.

Speaker Change: <unk> exceeded our expectations in the second half of the year due to competitor supply chain challenges that led to higher than anticipated market share.

Speaker Change: The rule provides separate payment for innovative radiopharmaceutical diagnostics like clarify following expiry of transitional pass through payment status for the approximately 20% of patients with traditional Medicare fee for service insurance coverage, who are treated in the hospital outpatient setting.

Speaker Change: <unk> long term success continues to be driven by our established clinical and commercial value.

Speaker Change: Strong history of clinical application and our ongoing commitment to operational excellence.

Speaker Change: Clarify op PFS Medicare fee for service payment rates are in a significantly better position than they would have been absent cms's adoption of separate payment and we plan to continue to engage CMS as well as other stakeholders to establish a payment based on average sales price or ASP.

Speaker Change: Yeah.

Speaker Change: In neurology, we continue to progress our pipeline of radio diagnostics for Alzheimer's disease or <unk>.

Speaker Change: We believe the U S. <unk> radio diagnostics total addressable market has the potential to grow to $1 $5 billion by the end of the decade, driven by the increasing number of treatment options expected to become available as well as increasing prevalence.

Speaker Change: <unk> has been reporting clarifies asps since launch and we believe other radiopharmaceutical diagnostics can as well, which would facilitate cms's ability to establish asps as the basis for separate payment in the future.

Speaker Change: This is supported by third party research, which estimates there to be over 100 therapies in clinical development targeting either beta amyloid or Tau.

Speaker Change: More broadly we believe this rule represents significant progress for the long term potential and sustainability of our existing diagnostic pipeline, including MK 60 to $40 and now $46 94, as well as those agents that would be included in our recently announced strategic transactions.

Speaker Change: Furthermore, the Alzheimer's Association work group and <unk> recently updated their guidelines to expand the appropriate use of both beta amyloid and Tau pet imaging for diagnosis prognosis eligibility response prediction and monitoring of select patient groups.

Speaker Change: We continue to invest in clarify, including assessing the benefits of PSNH pet imaging with Polaris high and intermediate favorable patient via the mirror study, which continues to enroll as well as in <unk> expressing tumors beyond prostate through additional phase <unk> studies.

Speaker Change: Finally, a recent Alzheimers and dementia Journal survey found that 90% of the nearly 300 dementia experts surveyed thought Tau pet tracers will add value to clinical practice and a cognitively impaired memory clinic population.

Speaker Change: We believe we are well positioned to aid in the diagnosis staging and monitoring of AED with MK $62 40, and now $46 94, as well as with the agents, we expect to acquire via life molecular imaging.

Speaker Change: We look forward to sharing more about our progress throughout 2025.

Speaker Change: The affinity continues to be the number one utilized ultrasound enhancing agent delivering fourth quarter net sales of $86 2 million up 17, 9% year over year.

Speaker Change: Like molecular imaging would add an existing commercial franchise.

Speaker Change: The affinity exceeded our expectations in the second half of the year due to competitor supply chain challenges that led to higher than anticipated market share.

Speaker Change: Celebrating our entry in the <unk> and dementia space with Neuroses a globally approved.

Speaker Change: <unk> long term success continues to be driven by our established clinical and commercial value strong history of clinical application and our ongoing commitment to operational excellence.

Speaker Change: <unk> pet imaging agent that estimate beta amyloid plaque density in adult patients with cognitive impairment, who are being evaluated for AEP and other causes of cognitive decline.

Speaker Change: In neurology, we continue to progress our pipeline of radio diagnostics for Alzheimer's disease or <unk>.

Speaker Change: Neuro seek has shown clinical differentiation from other approved beta amyloid agents and we plan to use our experience and capabilities and F 18, based radio diagnostics and those of life molecular team to grow this business.

Speaker Change: We believe the U S. <unk> radio diagnostics total addressable market has the potential to grow to $1 $5 billion by the end of the decade, driven by the increasing number of treatment options expected to become available as well as increasing prevalence.

We believe that our radio diagnostic portfolio, including now 46, 94, and <unk> $62 40 are highly complementary to like molecular portfolio, including neuro seat in Pi 'twenty six 'twenty.

Speaker Change: This is supported by third party research, which estimates there to be over 100 therapies in clinical development targeting either beta amyloid or Tau.

Speaker Change: We remain on track to submit an NDA for <unk> hundred $62 40 in 2025, and an NDA for NAV 46, 94 in 2026 and to close the life molecular transaction in the second half of 2025.

Speaker Change: Furthermore, the Alzheimer's Association work group and <unk> recently updated their guidelines to expand the appropriate use of both beta amyloid and Tau pet imaging for diagnosis prognosis eligibility response prediction and monitoring of select patient groups.

Speaker Change: We are excited about our pipeline, including the pending addition of evergreens Registrational stage net radio diagnostic Aqtobe, which would complement our therapeutic radio equivalent candidate Pnp 2003, and could deliver a fair gnostic like payer.

Speaker Change: Finally, a recent Alzheimers and dementia Journal survey found that 90% of the nearly 300 dementia experts surveyed thought Tau pet tracers will add value to clinical practice and a cognitively impaired memory clinic population.

Speaker Change: Pending the acquisition of evergreen receipt of FDA approvals and positive resolution of the PMT to 003 patent litigation, we expect to launch both products in 2026 and could offer near term revenue potential and diversification.

Speaker Change: We believe we are well positioned to aid in the diagnosis staging and monitoring of AED with MK $62, 40, and $46 94, as well as with the agents, we expect to acquire via life molecular imaging.

Speaker Change: We are also excited about the potential of evergreens clinical and preclinical thorough gnostic payors targeting novel molecular oncologic targets.

Speaker Change: Like molecular imaging would add an existing commercial franchise accelerating our entry in the <unk> and dementia space with neuroses a globally approved.

Speaker Change: Finally, we continue to advance our other clinical radiopharmaceutical programs that have the potential to be first or best in class in areas of significant unmet need.

Speaker Change: <unk> pet imaging agent that estimate beta amyloid plaque density in adult patients with cognitive impairment, who are being evaluated for AEP and other causes of cognitive decline.

Speaker Change: These include our RM to novel thorough gnostic pair targeting <unk> PR, otherwise known as Bombesin for prostate breast and other cancers, which we plan to advance to IND later this year.

Speaker Change: Neuro seek has shown clinical differentiation from other approved beta amyloid agents and we plan to use our experience and capabilities and F 18, based radio diagnostics and those of life molecular team to grow this business.

Speaker Change: And our embarked 15 targeted radio therapeutic for the treatment of osteosarcoma and other solid tumors as well as our trop two targeted radiotherapeutic.

Bob Marshall: I will now turn the call over to Bob.

Speaker Change: We believe that our radio diagnostic portfolio, including now $46 94, and <unk> $62 40 are highly complementary to like molecular portfolio, including neuro seat in Pi 'twenty six 'twenty.

Bob Marshall: Thank you Paul and good morning, everyone.

Bob Marshall: Highlights of the fourth quarter and full year financials, focusing on adjusted results with comparisons to the prior year period, unless otherwise noted.

Bob Marshall: Revenue for the fourth quarter was $391 1 million, an increase of 10, 5% and revenue for the full year was $1 billion 534.

Speaker Change: We remain on track to submit an NDA for <unk> hundred $62 40 in 2025, and the NDA for NAV 46, 94 in 2026 and to close the life molecular transaction in the second half of 2025.

Bob Marshall: An increase of 18, 3%.

Bob Marshall: Now turning to the details beginning with radiopharmaceutical oncology, which contributed $266 million of sales in the quarter up 15, 3% due primarily to the continued strength of clarify with sales of $266 million an increase of 15, 7%.

Speaker Change: We are excited about our pipeline, including the pending addition of evergreens Registrational stage net radio diagnostic aqtobe.

Speaker Change: Which would complement our therapeutic radio equivalent candidate PMT to 003 and could deliver a fair gnostic like payer.

Bob Marshall: The difference in growth rates is due to a nominal amount of <unk> sales in the prior year results.

Bob Marshall: Clarify posted full year sales of 105 8 billion, an increase of 24, 3% precision diagnostics fourth quarter revenue of $117 5 million was 16, 8% higher driven by a definitive at $86 2 million or 17, 9% higher and taconite at <unk>.

Speaker Change: Pending the acquisition of evergreen receipt of FDA approvals and positive resolution of the PMT to 003 patent litigation, we expect to launch both products in 2026 and could offer near term revenue potential and diversification.

Speaker Change: We are also excited about the potential of evergreens clinical and preclinical thorough gnostic payors targeting novel molecular oncologic target.

Bob Marshall: $5 1 million was up 16, 7% for the full year definitive revenue was $317 8 million up 13, 6% and technology revenue was $95 5 million up nine 3%.

Speaker Change: Finally, we continue to advance our other clinical radiopharmaceutical programs that have the potential to be first or best in class in areas of significant unmet need.

Bob Marshall: Lastly, strategic partnerships and other revenue was $7 7 million down.

Bob Marshall: Down 66, 2% for the fourth quarter due to the inclusion of our Relistor royalty milestone receipt in the prior year.

Speaker Change: These include our RM to novel thorough gnostic pair targeting <unk> PR, otherwise known as Bombesin for prostate breast and other cancers, which we plan to advance to IND later this year.

Bob Marshall: Full year revenue was $38 2 million led by sales of MK $62 40 for investigational use in third party clinical trials.

Speaker Change: And our embarked 15 targeted radio therapeutic for the treatment of osteosarcoma and other solid tumors as well as our trop two targeted radiotherapeutic.

Bob Marshall: Gross margin gross profit margin for the fourth quarter was 68% and in line with the full year result of 68, 3%.

Bob Marshall: But down 130 basis points year over year, due mainly to the relistor royalty milestones embedded in the prior year quarter.

Bob: I will now turn the call over to Bob.

Bob: Thank you Paul and good morning, everyone.

Bob: Provide highlights of the fourth quarter and full year financials, focusing on adjusted results with comparisons to the prior year period, unless otherwise noted.

Bob Marshall: Offset.

Bob Marshall: In part by favorable product mix with strong volume contributions from across the commercial portfolio.

Bob Marshall: Operating expenses at 29, 1% of net revenue in the quarter were 670 basis points unfavorable from the prior year, but within previously guided spending levels.

Speaker Change: Revenue for the fourth quarter was $391 1 billion, an increase of 10, 5% and revenue for the full year was $1 billion 534.

Bob Marshall: Increases in research and development.

Speaker Change: An increase of 18, 3%.

Bob Marshall: Planned investments to advance our innovative clinical stage portfolio <unk>.

Speaker Change: Now turning to the details beginning with radiopharmaceutical oncology, which contributed $266 million of sales in the quarter up 15, 3% due primarily to the continued strength of clarify with sales of $266 million an increase of 15, 7%.

Bob Marshall: <unk> was notably higher than the period with significant expense tied to business development activities.

Bob Marshall: Waiting to the potential acquisitions of like molecular and evergreen third optics, including but not limited to due diligence and legal expenses.

Speaker Change: The difference in growth rates is due to a nominal amount of his address sales in the prior year results.

Bob Marshall: The company does not adjust the management P&L for these types of expenses unless a specific transaction is signed within the same quarter.

Speaker Change: Clarify posted full year sales of 105 8 billion, an increase of 24, 3% precision diagnostics fourth quarter revenue of $117 5 million was 16, 8% higher driven by definitive at $86 2 million or 17, 9% higher and taconite at <unk>.

Bob Marshall: Other income and expense was $4 4 million of income for the quarter and $17 6 million for the year derived through interest income earned on invested cash balances offset by interest expense on the company's debt.

Bob Marshall: Operating profit for the quarter was $151 8 million a decrease of eight 4% and $643 3 million for the full year, an increase of seven 7%.

Speaker Change: $5 1 million was up 16, 7% for the full year definitive revenue was $317 8 million up 13, 6% and technology revenue was $95 5 million up nine 3%.

Bob Marshall: Total adjustments in the quarter totaled $157 million of expenses before taxes.

Speaker Change: Lastly, strategic partnerships and other revenue was $7 7 million.

Bob Marshall: Of this amount 22, 2% to $11 8 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization respectively.

Speaker Change: Down 66, 2% for the fourth quarter due to the inclusion of our Relistor royalty milestone receipt in the prior year.

Bob Marshall: A portion of the stock compensation expense is related to head count optimization, which took place last November.

Speaker Change: Full year revenue was $38 2 million led by sales of MK $62 40 for investigational use in third party clinical trials.

Bob Marshall: The company recorded in diets.

Bob Marshall: <unk> loss of $119 1 million attributed to an equity investment in perspective and radio <unk> the.

Speaker Change: Gross margin gross profit margin for the fourth quarter was 68% and in line with the full year result of 68, 3%.

Bob Marshall: The remainder is related to acquisition integration and other nonrecurring expenses are.

Speaker Change: But down 130 basis points year over year, due mainly to the relistor royalty milestones embedded in the prior year quarter.

Bob Marshall: Our effective tax rate was 26, 1% in the quarter and 26, 7% for the full year.

Speaker Change: Offset.

Speaker Change: In part by favorable product mix with strong volume contributions from across the commercial portfolio.

Bob Marshall: The resulting reported net loss for the fourth quarter was $11 8 million and a profit of $115 4 million on an adjusted basis, a decrease of five 9% from the prior year period.

Speaker Change: Operating expenses at 29, 1% of net revenue in the quarter were 670 basis points unfavorable from the prior year, but within previously guided spending levels.

Bob Marshall: GAAP fully diluted earnings per share for the fourth quarter were a loss of <unk> 17 and.

Speaker Change: Increases in research and development.

Bob Marshall: And a profit of $1 59 on an adjusted basis the decrease in the prior year of 9%.

Speaker Change: Planned investments to advance our innovative clinical stage portfolio <unk>.

Speaker Change: <unk> was notably higher than the period with significant expense tied to business development activity.

Bob Marshall: Full year basis, GAAP fully diluted earnings per share were a profit of $4 36.

Speaker Change: <unk> the potential acquisitions of like molecular and evergreen third optics, including but not limited to due diligence and legal expenses.

Bob Marshall: And a profit of $6 76 on an adjusted basis, an increase of eight 6% over the prior year.

Speaker Change: The company does not adjust the management P&L for these types of expenses unless a specific transaction is signed within the same quarter.

Bob Marshall: Now turning to cash flow fourth quarter operating cash flow totaled $157 7 million as compared to $112 million in Q4 2023.

Speaker Change: Other income and expense was $4 4 million of income for the quarter and $17 6 million for the year derived through interest income earned on invested cash balances offset by interest expense on the company's debt.

Bob Marshall: Capital expenditures totaled $16 4 million for three more than the year prior.

Bob Marshall: Free cash flow, which we define as operating cash flow less capital expenditures was $141 4 million an increase of $41 1 million during the full year. The company generated $493 1 million of free cash flow. Additionally, the company repurchased approximately $100 million or $1 2 million of its.

Speaker Change: Operating profit for the quarter was $151 8 million a decrease of eight 4% and $643 3 million for the full year, an increase of seven 7%.

Speaker Change: Total adjustments in the quarter totaled $157 million of expenses before taxes of this.

Bob Marshall: <unk> owned shares during the quarter.

Bob Marshall: Having $150 million of buyback authorization outstanding.

Speaker Change: This amount of $22 two was $11 8 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization, respectively. A portion of the stock compensation expense is related to head count optimization, which took place last November.

Bob Marshall: During the fourth quarter the company refinanced its revolving senior credit facility, increasing borrowing capacity to $750 million from $350 million and extended the maturity date to 2029, enhancing our strong liquidity position.

Speaker Change: The company recorded in <unk>.

Bob Marshall: Lastly.

Speaker Change: <unk> loss of $119 1 million attributed to its equity investment in perspective and radio <unk> the.

Bob Marshall: Cash and cash equivalents net of restricted cash now stands at $912 8 million.

Bob Marshall: Turning now to guidance for 2025 full year and recall, we are only providing full year guidance for this year.

Speaker Change: The remainder is related to acquisition integration and other nonrecurring expenses are.

Speaker Change: Our effective tax rate was 26, 1% in the quarter and 26, 7% for the full year.

Bob Marshall: Additionally, this guy does not include the pro forma impacts of previously announced transactions expected to close later this year, namely life molecular imaging and evergreen.

Speaker Change: The resulting reported net loss for the fourth quarter was $11 8 million and a profit of $115 4 million on an adjusted basis, a decrease of five 9% from the prior year period.

Bob Marshall: The company will update financial expectations. After each transaction is actually closed.

Bob Marshall: We estimate full year net revenue to be in a range of one $545 to $1 six 1 billion, an increase of 1% to 5% over 2024.

Speaker Change: GAAP fully diluted earnings per share for the fourth quarter were a loss of <unk> 17 and.

Speaker Change: And a profit of $1 59 on an adjusted basis the decrease in the prior year of 9%.

Bob Marshall: We expect <unk> to grow low to mid single digits on a net basis the affinity with a low to mid single digit growth profile will face headwinds from opportunistic sales in 2024, but maintain a two year stacked growth rate of high single digits for modeling purposes gross profit margin should be materially similar to 2024.

Speaker Change: Full year basis, GAAP fully diluted earnings per share were a profit of $4 36.

Speaker Change: And a profit of $6 76 on an adjusted basis, an increase of eight 6% over the prior year.

Speaker Change: Now turning to cash flow fourth quarter operating cash flow totaled $157 7 million as compared to $112 million in Q4 2023.

Bob Marshall: Levels at approximately 68%.

Bob Marshall: Operating expenses should be reflective of the second half of 2024, which famers R&D investments overall sales and marketing and G&A expenses should be flat to down year over year with R&D investments up 100 to 150 basis points, all as a percent of net revenue.

Speaker Change: Capital expenditures totaled $16 4 million $4 three more than the year prior free.

Speaker Change: Free cash flow, which we define as operating cash flow less capital expenditures was 141 4 million an increase of $41 1 million during the full year. The company generated $493 1 million of free cash flow. Additionally, the company repurchased approximately $100 million or $1 2 million of it is.

Bob Marshall: Interest income given the heightened cash balances and the forward curve should provide $40 million of income, though offset by $19 5 million of interest expense. Therefore for the full year, we expect fully diluted adjusted earnings per share to be in a range of $7 and $7 20 and.

Speaker Change: Own shares during the quarter, leaving $150 million of buyback authorization outstanding.

Bob Marshall: An increase of three five to six 5% over 2024.

Speaker Change: During the fourth quarter the company refinanced its revolving senior credit facility, increasing borrowing capacity to $750 million from $350 million and extended the maturity date to 2029, enhancing our strong liquidity position.

Bob Marshall: Lastly, the company expects free cash flow to.

Bob Marshall: <unk> to expand through 2025, with an anticipated amount of $550 to $600 million.

Bob Marshall: Adding the company along with current cash balances more than sufficient liquidity to execute its business development priorities as well as returning a portion of its portion to stockholders through buybacks.

Speaker Change: Lastly.

Speaker Change: Cash and cash equivalents net of restricted cash now stands at $912 8 million.

Speaker Change: Turning now to guidance for 2025 full year and recall, we are only providing full year guidance that share it.

Bob Marshall: Finally for modeling purposes, depreciation and amortization for the full year 2025 to be approximately 15% and $41 million, respectively generally spread evenly throughout the year.

Speaker Change: Additionally, this guide does not include the pro forma impacts of previously announced transactions expected to close later this year, namely life molecular imaging and evergreen.

Bob Marshall: Fully diluted shares outstanding should be approximately 71 $5 million, which takes into account the share repurchase executed in Q4.

Speaker Change: The company will update financial expectations. After each transaction is actually closed.

Brian Marcussen: With that I'll turn the call back over to Brian.

Speaker Change: We estimate full year net revenue to be in a range of one $545 to $1 six 1 billion increase of 1% to 5% over 2024.

Speaker Change: Thank you Bob.

We are pleased with our strong performance in 2024.

Speaker Change: I'm excited about our momentum in 2025 and beyond.

Speaker Change: We expect <unk> to grow low to mid single digits on a net basis definitive with a low to mid single digit growth profile will face headwinds from opportunistic sales in 2024, but maintain a two year stack growth rate of high single digits for modeling purposes gross profit margin should be materially similar to 2024.

Speaker Change: We are well positioned to grow clarify and definitive advance our existing pipeline and close out two recently announced strategic transactions.

Speaker Change: To become a fully integrated radio pharmaceutical company.

Speaker Change: These pending transactions will enable us to concentrate on enhancing our capabilities across the radiopharmaceutical value chain.

Speaker Change: Levels at approximately 68%.

Speaker Change: Operating expenses should be reflective of the second half of 2024, which famous R&D investments overall sales and marketing and G&A expenses should be flat to down year over year with R&D investment of 100 to 150 basis points, all as a percent of net revenue.

Speaker Change: Including in Alzheimers diagnostics in oncology therapeutics.

Speaker Change: Entering new markets with significant growth potential that diversify our business and.

Speaker Change: And expanding our pipeline with potentially best a first in class radiopharmaceutical diagnostic pairs.

Speaker Change: Interest income given the heightened cash balances and the forward curve should provide $40 million of income, though offset by $19 5 million of interest expense. Therefore for the full year, we expect fully diluted adjusted earnings per share to be in the range of $7 and $7 20 in.

Including the potential for multiple commercially approved products in 2026.

Speaker Change: In closing we are confident that our strategy will enhance our radiopharmaceutical leadership.

Speaker Change: Drive growth.

Speaker Change: An increase of three five to six 5% over 2024.

Speaker Change: Build long term shareholder value and bring innovative products to patients with that we're ready to take your questions. Operator. Please go ahead.

Speaker Change: Lastly, the company expects free cash flow to.

Speaker Change: <unk> to expand through 2025, with an anticipated amount of $550 to $600 million.

Speaker Change: Thank you.

Speaker Change: Reminder, to ask a question. Please 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, we ask that you. Please limit yourselves to one question. Please.

Speaker Change: Providing the company along with current cash balances more than sufficient liquidity to execute its business development priorities as well as returning a portion of it.

Speaker Change: Proportionate to stockholders through buybacks.

Speaker Change: Finally for modeling purposes, depreciation and amortization for the full year 2025 to be approximately 15% and $41 million, respectively generally spread evenly throughout the year.

Speaker Change: Please stand by while we compile the Q&A roster.

Speaker Change: Our first question comes from the line of Rowenta Reece from Leerink partners.

Speaker Change: Fully diluted shares outstanding should be approximately 71 $5 million, which takes into account the share repurchase executed in Q4.

Rowenta Reece: Hi, good morning, everyone.

Rowenta Reece: I was curious could you give us a status update on the mirror study that you mentioned briefly and talk a bit about more its implications on clarify and I was curious what the timing is still on track or a little bit delayed versus what you thought before.

Brian: With that I'll turn the call back over to Brian.

Brian: Thank you Bob.

Speaker Change: We are pleased with our strong performance in 2024.

Brian: I'm excited about our momentum in 2025 and beyond.

Brian: We are well positioned to grow clarify and affinity advance our existing pipeline and close out two recently announced strategic transactions.

Rowenta Reece: Brandon Thanks for the question. So the mirror study is our study to assess the use of <unk> pet with Polaris Phi in the intermediate favorable setting.

Brian: To become a fully integrated radio pharmaceutical company.

Rowenta Reece: As a reminder, this is not necessarily if you will a registrational study because Polaris <unk> has a very broad label and the staging where it identifies the risk of metastases, but it doesn't distinguish the level of risk and so the CCN and the ethanol and other guidelines agencies is effectively <unk>.

Brian: These pending transactions will enable us to concentrate on enhancing our capabilities across the radiopharmaceutical value chain.

Brian: Including in Alzheimers diagnostics in oncology therapeutics.

Brian: Entering new markets with significant growth potential that diversify our business and.

Brian: And expanding our pipeline with potentially best a first in class radiopharmaceutical diagnostic pairs.

Rowenta Reece: Amended use of <unk> pet with Polaris high in their intermediate unfavorable and the high end very high risk patient population, we began studying PMMA pet with clarifying intermediate favorable patients.

Brian: Including the potential for multiple commercially approved products in 2026.

Brian: In closing we are confident that our strategy will enhance our radiopharmaceutical leadership.

Rowenta Reece: Last year that continues to enroll we would expect to have the last patient in sometime in the fourth quarter of 2025, then to be able to follow those patients duty right clinical trial analysis as well as publishing with the hopes of having guidelines farm end CCN in SNF EMI.

Brian: Drive growth.

Brian: Build long term shareholder value and bring innovative products to patients with that we're ready to take your questions. Operator. Please go ahead.

Brian: Thank you.

Speaker Change: Reminder, to ask a question. Please 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, we ask that you. Please limit yourselves to one question. Please.

Rowenta Reece: Updated in the coming years, which that could influence payer policies and overall expand the addressable market for the staging population and I think youll note that in our total addressable market. We would expect that staging population to increase from approximately 145000 scans annually potential.

Speaker Change: Please stand by while we compile the Q&A roster.

Rowenta Reece: Today to approximately 175 by the end of the decade.

Rowenta Rice: Our first question comes from the line of Rowenta Rice from Leerink partners.

Speaker Change: Thank you.

Rowenta Reece: One moment for our next question.

Rowenta Rice: Hi, good morning, everyone.

Rowenta Rice: I was curious could you give us a status update on the mirror study that you mentioned briefly and talk a bit about more its implications on clarify and I was curious if the timing is still on track or a little bit delayed versus what you thought before.

Speaker Change: Our next question comes from the line of Anthony Petrone from Mizuho Financial group.

Anthony Petrone: Thanks, and congrats on just a strong year over overall getting clarified a $1 billion in the recent transactions, maybe just to stick on the U S. USP SMA.

Rowenta Rice: Brandon Thanks for the question. So the mirror study is our study to assess the use of <unk> pet with Polaris Phi in the intermediate favorable setting.

Speaker Change: Dynamics.

Speaker Change: So maybe one just a little bit on the competitive dynamics with the new reimbursement change that's effective.

January 1st I know you mentioned most of your customers are now contracted but just anything you're seeing.

Brian: As a reminder, this is not necessarily if you will a registrational study because Polaris <unk> has a very broad label in the staging where it identifies the risk of metastases, but it doesn't distinguish the level of risk and so the CCN and the ethanol and other guidelines agencies is effectively <unk>.

Speaker Change: Competitively a market shifts there's this new reimbursement code.

Speaker Change: Has come in and then and then secondly, the competitors out there.

Speaker Change: We're looking at basically a re engineered reformulated version, if you will of their P. SMA pet agent.

Brian: Amended use of PMA pet with Polaris high in their intermediate unfavorable and the high end very high risk patient population, we began studying PMMA pet with clarifying intermediate favorable patients.

Speaker Change: Just expectations on that on whether or not that's baked into the guide and what you think that does for the competitive landscape. Thanks, again and congrats on a strong year all around.

Brian: Last year that continues to enroll we would expect to have the last patient in sometime in the fourth quarter of 2025, then to be able to follow those patients do the right clinical trial analysis as well as publishing with the hopes of having guidelines farm end CCN in SNF EMI.

Speaker Change: Yes, Thanks, Anthony I'll start with the back end of your question and then turn it over to Paul and Amanda for the second half for the first question part of the question anyway.

Speaker Change: With regard to a new product entrants I think.

Speaker Change: It's gallium the images are not as good as clarifying images.

Brian: Updated in the coming years, which that could influence payer policies and overall expand the addressable market for the staging population and I think you'll note that in our total addressable market. We would expect that staging population to increase from approximately 145000 scans annually potential.

Speaker Change: There has been a little bit of noise about it.

Speaker Change: I don't really see a big.

Speaker Change: No.

Speaker Change: Sort of influx to anything thats happening with Polaris <unk>, So theyre doing what theyre doing and good for them and we're going to keep on executing our game plan.

Speaker Change: So Paul Yes, no Anthony Thanks for the question, maybe I'll just tackle somebody and you see kind of CMS piece, and then I'll turn it over to Amanda talk about some of the competitive dynamics that we're seeing in the marketplace.

Brian: Today to approximately 175 by the end of the decade.

Brian: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: So I think as we.

Speaker Change: Our next question comes from the line of Anthony Petrone from Mizuho Financial group.

Speaker Change: As we've said I think we're incredibly excited about the CMS shift to <unk> versus where we were previously expected to be from the expiry of transitional pass through payment status and this is clearly a benefit for clarify, but I think more broadly as the clear leader in radiopharmaceutical diagnostics with Polaris and <unk>.

Speaker Change: Thanks, and congrats on just a.

Brian: Strong year over overall getting clarify to $1 billion in the recent transactions, maybe just to stick on the U S. USP SMA pet dynamics.

Brian: So maybe one just a little bit on the competitive dynamics with the new reimbursement change that's effective.

Speaker Change: Credibly strong pipeline with MK $62 40 of now 46 94 of our FAP agent earlier in development as well as some of the pending acquisitions with the addition of heavy of neurosurgery and earlier stage. There <unk> I think we're incredibly pleased for the long term growth potential.

Brian: First I know you mentioned most of your customers are now contracted but just anything you're seeing.

Brian: Competitively a market shifts as this new reimbursement code.

Brian: He's come in and then and then secondly, the competitors out there.

Speaker Change: Sustainability and payment dynamics related to MDC and so I think we think this is a big win we're naturally going to continue to work with the agency to shift to Asps over time, but I think we're really pleased overall with the market and what this does to the growth and sustainability of the radiopharmaceutical diagnostics space, maybe I'll turn it over to Amanda to talk a little.

Brian: We're looking at basically a re engineered reformulated version, if you will of their PSA pet agent.

Brian: Just expectations on that on whether or not that's baked into the guide and what you think that does for the competitive landscape. Thanks, again and congrats on a strong year all around.

Amanda Morgan: More about the competitive dynamics, yes, thanks Paul.

Speaker Change: Yes, Thanks, Anthony I'll start with the back end of your question and then turn it over to Paul and Amanda for the second half, but the first question part of the question anyway.

Speaker Change: As we shared on our commentary during the call that we secured the vast majority of hospital and freestanding imaging centers with multiyear contracts.

Speaker Change: With regard to a new product entrants I think.

Amanda Morgan: Will enable us to continue to leverage our strategic partnerships.

Speaker Change: It's gallium the images are not as good as clarifying images.

Amanda Morgan: But I will say is that I'm very pleased with the evolution of this strategy and the partnership.

Speaker Change: Theres been a little bit of noise about it.

Amanda Morgan: We expect to continue to capitalize on <unk> clinical and commercial differentiation to support its clear market leadership and pricing premiums even with the current competitive market dynamics.

Speaker Change: I don't really see a big.

Speaker Change: No.

Speaker Change: Sort of influx to anything thats happening with Polaris Fi, So theyre doing what theyre doing and good for them and we're going to keep on.

Speaker Change: Can you just kind of talking a little bit more about our commercial differentiation in our clinical differentiation from our commercial differentiation perspective, we have the largest dedicated commercial team.

Speaker Change: Executing our game plan.

Speaker Change: So Paul Yes, Anthony Thanks for the question, maybe I'll just tackle somebody and you see kind of CMS piece, and then I'll turn it over to Matt to talk about some of the competitive dynamic that we're seeing in the marketplace.

Speaker Change: Additionally, we have broad payer access.

Speaker Change: I think as we.

Speaker Change: With more than 90% of lives having access to Polaris Sai.

Speaker Change: <unk>.

Speaker Change: As we've said I think we're incredibly excited about the CMS shift too and you see versus where we were previously expected to be from the expiry of transitional pass through payment status and this is clearly a benefit for clarify, but I think more broadly as the clear leader in radiopharmaceutical diagnostics with Polaris and <unk>.

Speaker Change: We have a longer half life, which is a distribution advantage that enables us to optimize on our multi partner.

Speaker Change: Manufacturing facility network.

Speaker Change: This makes Polaris <unk> widely available.

Speaker Change: Adverse supply chain.

Speaker Change: And shrink convenient and reliable supply and over 48 state.

Speaker Change: Credibly strong pipeline with MK $62 40 of now 46 94 of our FAP agent earlier in development as well as some of the pending acquisitions with the addition of heavy of Neuroses and earlier stage Theyre Gnostic Paris, I think we're incredibly pleased for the long term growth potential.

Speaker Change: And then from a clinical differentiation perspective, there's really three things there is clarity from a diagnostics perspective, meaning accurate detection rate without the high false positive rate.

Speaker Change: We have clarity in the intended patient management.

Speaker Change: Based on robust pivotal clinical data.

Speaker Change: Sustainability and payment dynamics related to MVC and so I think we think this is a big win we're naturally going to continue to work with the agency to shift to ASP over time, but I think we're really pleased overall with the market and what this does to the growth and sustainability of the radiopharmaceutical diagnostic space, maybe I'll turn it over to Amanda to talk a little.

Speaker Change: And clarity from consistency and brita interpretation or high inter reader agreement.

Speaker Change: So by driving differentiation through clinical and commercial differentiation, our long term strategic partnership.

Speaker Change: And an optimal customer experience, we plan to continue to grow clarify both in volume and net sales in 2025.

Amanda: More about the competitive dynamics, yes, thanks Paul.

Amanda: As we shared on our commentary during the call that we secured the vast majority of hospital and freestanding imaging centers with multiyear contracts.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Amanda: Will enable us to continue to leverage our strategic partnerships.

Speaker Change: Okay.

Speaker Change: Our next question comes from the line of Richard <unk> from <unk> Securities.

Amanda: But I will say is that I'm very pleased with the evolution of the strategy and the partnership.

Richard: Hi, Thanks for taking the questions.

Amanda: We expect to continue to capitalize on clarifies clinical and commercial differentiation to support its clear market leadership and pricing premiums even with the current competitive market dynamics.

Speaker Change: Maybe on on Polaris Sai.

Richard: Any any color you can provide.

Richard: On the cadence and pacing of the Polaris high growth within that low single digit to mid single digit.

Amanda: Can you just kind of talking a little bit more about our commercial differentiation in our clinical differentiation from our commercial differentiation perspective, we have the largest dedicated commercial team.

Richard: And specifically in the first half of the year should we expect Polaris to grow in all quarters, including the first quarter.

Speaker Change: So rich good morning, I'll take that.

Amanda: Additionally, we have broad payer access.

Speaker Change: So I think that our guidance actually kind of has captured sort of a range of different scenarios.

Amanda: With more than 90% of lives having access to Polaris Sai.

Amanda: We have a longer half life, which is a distribution advantage that enables us to optimize on our multi partner man.

Speaker Change: Toward the low end I think you would expect sort of a flattish first half with modest growth in the second half. That's how you get to that sort of a low end of the range that takes considerations sort of anniversarying as we go through the strategic partnerships as more of those contracts actually come into full sort of value. If you will.

Amanda: Factoring facility network.

Amanda: This makes Polaris <unk> widely available.

Amanda: Our supply chain.

Amanda: And shrink convenient and reliable supply and over 48 state.

Speaker Change: But if you think towards the higher end of the range really what that does imply yes as growth in the first half of <unk>.

Amanda: And then from a clinical differentiation perspective, there's really three things theres clarity from a diagnostics perspective, meaning.

Speaker Change: The year.

Speaker Change: Actually increasing to sort of the mid single high single digit kind of growth in the back half of the year. So.

Amanda: Meaning accurate detection rate without the high false positive rate.

Speaker Change: The scenario is going to capture like.

Amanda: We have clarity and intended patient management.

Speaker Change: Very nice growth profile, no matter, where we are in the whole thing.

Amanda: Just on robust pivotal clinical data.

Speaker Change: And it is very reflective of the hard work that the commercial team has done to get these strategic partnerships put in place.

Amanda: And clarity from consistency in breeder interpretation or high inter reader agreement so.

Amanda: By driving differentiation through clinical and commercial differentiation.

Speaker Change: Thank you.

Amanda: Long term strategic partnership.

Speaker Change: One moment for our next question.

Amanda: In an optimal customer experience, we plan to continue to grow clarify both in volume and net sales in 2025.

Speaker Change: Our next question comes from the line of Paul Choi from Goldman Sachs.

Amanda: Thank you.

Paul Choi: Alright, Thanks, and good morning, everyone. Thanks for taking the question.

Amanda: One moment for our next question.

Paul Choi: My question is on <unk>, and just as you're thinking about the partnership with.

Amanda: Okay.

Richard: Our next question comes from the line of Richard <unk> from <unk> Securities.

Paul Choi: Your partnership there can you maybe just update us on what are the inputs that are involved in the decision process of potentially going forward movement with the co promote here and just kind of what has been the.

Richard: Hi, Thanks for taking the questions.

Richard: Maybe on on Polaris Sai.

Richard: Any any color you can provide.

Richard: On the cadence and pacing of the Polaris high growth within that low single digit to mid single digit.

Paul Choi: So the rate limiting step from from <unk> perspective, Thank you.

Speaker Change: Yes, Paul I. Appreciate the question. Good morning at this time, we're not anticipating entering into the co promote option.

Richard: Specifically in the first half of the year should we expect Polaris to grow in.

Speaker Change: With GE, there are more than capable of achieving their ambition.

Richard: All quarters, including the first quarter.

Rich: So rich good morning, I'll take that.

Speaker Change: And we're here to support them if they need it.

So I think that our guidance actually kind of has captured sort of a range of different scenarios.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Rich: Towards the low end I think you would expect sort of a flattish first half with modest growth in the second half. That's how you get to that sort of a low end of the range that takes considerations sort of anniversarying as we go through the strategic partnerships as more of those contracts actually come into full sort of value. If you will.

Speaker Change: Our next question comes from the line of Matt Taylor from Jefferies.

Matt Taylor: Hey, good morning, Thank you for taking my question.

Speaker Change: Wanted to go back to I think it was Paul before was talking about.

Speaker Change: The potential for CMS to go to an AFP based methodology.

Rich: If you think towards the higher end of the range really what that does imply yes as growth in the first half of it.

Speaker Change: All the folks now reporting that can.

Rich: The year.

Speaker Change: Can you talk about the potential for that to happen this year versus next year.

Rich: Actually increasing to sort of the mid single high single digit kind of growth in the back half of the year. So so if the scenario is kind of capture Mike.

Speaker Change: Both happen in the portfolio, how do you think that changes your growth potential for <unk>, and 26% or twice up and with the changes.

Rich: A very nice growth profile no matter, where we are in the whole thing.

Speaker Change: Will you want to do that or do you want me to.

Rich: And it is very reflective of the hard work that the commercial team has done to get these strategic partnerships put in place.

Speaker Change: <unk> great.

Speaker Change: So it is a little hard to predict what's going to be happening down within the beltway as you know.

Speaker Change: So hopefully of stores will stay open but.

Rich: Thank you.

Rich: One moment for our next question.

Speaker Change: So look if they migrate to AOSP, we look at that as upside to the business.

Speaker Change: Our next question comes from the line of Paul Choi from Goldman Sachs.

Speaker Change: That simple.

Speaker Change: Paul.

Speaker Change: I think that's spot on I think the CMS will continue to assess.

Paul Choi: Alright, Thanks, and good morning, everyone. Thanks for taking the question.

Speaker Change: Established draft rules this summer in July.

Paul Choi: My question is on <unk>, and just as you're thinking about the partnership with.

Speaker Change: Then they come out and collect comments throughout the fall they come out with final rules proposed rules in the November timeframe to take effect in 2000 and so.

Paul Choi: Your partnership there can you maybe just update us on what.

Paul Choi: Are the inputs that are involved in the decision process of potentially going forward movement with the co promote here and just kind of what has been the.

Speaker Change: So Matt just to be specific I think the earliest we could potentially see this is Jan 126, but we would see those draft rules in July I think CMS remained open to adjusting for Asps.

Paul Choi: So the rate limiting step from from the <unk> perspective. Thank you.

Speaker Change: Yeah, Paul I. Appreciate the question. Good morning at this time, we're not anticipating entering into the co promote option.

Speaker Change: Clearly that requires the industry to report our ASP for the vast majority of product that would be subject to the separate payment status.

Speaker Change: With GE, there are more than capable of achieving their ambition.

Speaker Change: Our base case is for MFC.

Speaker Change: And we're here to support them if they need it.

Speaker Change: In 'twenty, five and beyond and if we received asps that would just further support the payment dynamics.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: Of the overall PMA pet diagnostics of guidance and our expectations are based on and you see for the full year of 2020.

Speaker Change: Our next question comes from the line of Matt Taylor from Jefferies.

Matt Taylor: Hey, good morning, Thank you for taking my question.

Speaker Change: Thank you one moment for our next question.

Speaker Change: Wanted to go back to I think it was Paul before was talking about.

Speaker Change: Our next question comes from the line of Yuan Ju from B Riley.

Speaker Change: The potential for CMS to go to an AFP based methodology.

Speaker Change: Ill, let folks know reporting that.

Yuan Ju: Good morning, Thank you for taking our questions. Although periodic finally will be paid in separated payments. After this pass through expires in January the reimbursement of the price is lower than competitors.

Speaker Change: Can you talk about the potential for that to happen this year versus next year.

Speaker Change: Does happen in the portfolio, how do you think that changes your growth potential for <unk> and <unk>.

Speaker Change: 6% or twice that benefit changes.

Speaker Change: Some customers are racing from <unk> or <unk> before the CMS policy update I'm curious to hear how the situation is dynamic.

Speaker Change: Will you want to do that or do you want me to.

Speaker Change: I hope you take payment great alright.

Speaker Change: So it is a little hard to predict what's going to be happening down within the beltway as you know.

Yuan Ju: Played out recently.

Speaker Change: So hopefully it stores will stay open but.

Yuan Ju: Thanks.

Amanda Morgan: So I will tag team that with Amanda but as you.

Speaker Change: So look if they migrate to ASP, we look at that as upside to the business.

Speaker Change: Hurt us repeatedly.

Speaker Change: Our strategic contracts.

Speaker Change: That simple.

Speaker Change: Paul.

Speaker Change: I think thats spot on I think the CMS will continue to establish.

Speaker Change: Our in place with the vast majority of our customers and that strategy was set in motion over a year ago and.

Speaker Change: Established draft rules this summer in July.

Speaker Change: So we're very comfortable and it anticipated essentially no change to any of the rules. So the fact that we have at <unk> have a separate payment is really upside to what we were originally thinking.

Speaker Change: Then they come out and collect comments throughout the fall they come out with final rules proposed rules in the November timeframe to take effect in 2000 and so.

Matt Taylor: So Matt just to be specific.

Matt Taylor: The earliest we could potentially see this is Jan 126, but we would see those draft rules in July I think CMS remains open to adjusting for Asps.

And planning and we never changed our strategy and tactics.

Speaker Change: All the way through so.

Speaker Change: While it's true that the competition is trying to nibble at the borders.

Matt Taylor: Clearly that requires the industry to report.

Amanda Morgan: We've kept the wall up so Amanda anything want to add to that yeah, a little added.

Matt Taylor: For the vast majority of product that would be subject to the separate payment status on our base case is for <unk> in.

Speaker Change: It's a complex market right.

Speaker Change: Factors in here and play here from the commercial differentiation that I talked about the clinical differentiation, but theres also an availability piece right and so that does have an important piece of how this market play.

Matt Taylor: In 'twenty, five and beyond and if we received asps that would just further support the payment dynamics.

Matt Taylor: <unk>.

Overall, PMA pet diagnostics of guidance and our expectations are based on <unk> for the full year of 2009.

Speaker Change: Select markets, where there is limited access to clarify in an early morning or late afternoon.

Speaker Change: And we will continue to build that through our P&L network and expanding our manufacturing time slot.

Thank you one moment for our next question.

Speaker Change: Our next question comes from the line of Yuan Ju from B Riley.

Speaker Change: Really I would just go back to kind of what we hear from accounts.

Speaker Change: Prefer S 18, when its available.

Yuan Ju: Good morning, Thank you for taking our questions, although periodic filing will be paid in separate payments. After this pass through expire in January the reimbursement and the price is lower than our competitors.

Speaker Change: And we've done a fantastic job at getting.

Speaker Change: Patient access to clarify getting accounts access to clarify and then just as Brian shared really through our strategic partnerships.

Speaker Change: Heard some customers are raising from <unk> more pumps, new marquee <unk> before the CMS policy update I am curious to hear how the situation is dynamic.

Speaker Change: We have been able to as we shared at really secure a vast majority of our hospital and freestanding imaging centers.

Yes, and the other thing to note is our <unk>.

Yuan Ju: Eight out recently thank you.

Speaker Change: Service statistics customer support along with our Pls partnerships is just outstanding. So appreciate the question well locked and loaded.

Yuan Ju: So I'll tag team that with amendment, but as you heard us repeatedly.

Yuan Ju: Our strategic contracts.

Speaker Change: Thank you one moment for our next question.

Yuan Ju: Our in place with the vast majority of our customers and that strategy was set in motion over a year ago and.

Speaker Change: Our next question comes from the line of Larry Solow from CJS Securities.

And so we're very comfortable and it anticipated essentially no change to any of the rules. So the fact that we have at <unk> have a separate payment is really upside to what we were originally thinking.

Larry Solow: Good morning, I guess I just wanted to just follow up on Richard's question on the on the cadence of the year.

I guess, we can infer that the impact of price obviously is waning in the back half.

Yuan Ju: And planning and we never changed our strategy and tactics.

Yuan Ju: All the way through so.

Larry Solow: So my question is kind of what does that mean as we look out to 'twenty six should we actually.

Yuan Ju: While it's true that the competition is trying to nibble at the borders.

Larry Solow: Give a guidance for 'twenty six but long term this should.

Yuan Ju: We've kept the wall up so Amanda anything want to add to that yes.

Larry Solow: It sounds like it's a one year reset should we expect kind of.

Larry Solow: Price to at least not be a headwind as we look out into 2006.

Yuan Ju: Listen, it's a complex market right.

Speaker Change: Factors in here and play here from the commercial differentiation that I talked about the clinical differentiation, but theres also an availability piece right and so that does have an important piece of how this market play.

Larry Solow: Second part of that question is just.

Speaker Change: I don't know if you can give us a little more concrete numbers here, but I felt like the price impact in the back half of this year or in Q4 was pretty muted. So I assume there will be some impact going forward at least in the front half of the year. Thanks.

Speaker Change: Select markets, where there is limited access to clarify and early morning, or late afternoon, and we will continue to build that through our P&L network and expanding our manufacturing time slot.

Speaker Change: Yeah, Larry Thanks for that question I.

Speaker Change: I think your assessment is right that this year 2025 is going to be more reflective of the price dynamics as we anniversary through the strategic contracting.

Speaker Change: Really I would just go back to kind of what we hear from accounts.

Speaker Change: Prefer F 18, when its available.

Speaker Change: With our with our partners.

Speaker Change: And we've done a fantastic job at getting.

Speaker Change: And so the normal seasonality, if you will isn't necessarily going to be reflective within the <unk> franchise, we will see seasonality.

Speaker Change: Patient access to clarify getting accounts access to clarify and then just as Brian shared really through our strategic partnerships.

Speaker Change: Normally see with with a definitive for instance.

Speaker Change: But.

Speaker Change: As we look into 2026 as we anniversary through yes, we do have a sense of of <unk>.

Speaker Change: We really have been able to as we shared at really secure a vast majority of our hospital and freestanding imaging centers.

Speaker Change: Bringing those sort of foundational products and in clarifying definitive back to more of a seasonally cadence.

Speaker Change: Yes, and the other thing to note is our <unk>.

Speaker Change: Service statistics customer support along with our Pls partnerships is just outstanding So I appreciate the question well locked and loaded.

Speaker Change: Sort of low if you will.

Speaker Change: Of.

Speaker Change: Of revenue stream.

Speaker Change: Maybe just to add Larry on the specific kind of pricing dynamics in the second half of 'twenty four.

Speaker Change: Thank you one moment for our next question.

Speaker Change: We did see sequential declines if you look at the first half of 'twenty for pricing and you look at the second half of 'twenty for pricing from an actual realized we did see a decline now thats with the overall raising prices and others to help to offset some of those but that will normalize as Bob is men's.

Speaker Change: Our next question comes from the line of Larry Solow from CJS Securities.

Speaker Change: Good morning, I guess I just wanted to just follow up on Richard's question on the just on the <unk>.

Speaker Change: <unk> for the year I.

Speaker Change: I guess, we can infer that the impact of price obviously is waning in the back half.

Speaker Change: And as we get to the second half of 'twenty five because those year over year comps are now included.

Speaker Change: So my question is kind of what does that mean as we look out to 'twenty six should we actually.

Speaker Change: And that we did take a mid single digit price increase at the beginning of 'twenty four we highlighted that we did the same slightly earlier in 25 years.

Speaker Change: Not giving guidance for 'twenty, six but long term.

Speaker Change: Sounds like it's a one year reset should we expect kind of.

Speaker Change: Just to at least not be a headwind as we look out into 2006.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: Second part of that question is just.

Speaker Change: Our next question comes from the line of Justin Walsh from Jones trading.

I don't know if you can give us a little more concrete numbers here, but I felt like the price impact in the back half of this year or in Q4 was pretty muted.

Justin Walsh: Hi, Thanks for taking the question you noted <unk> is expected to expand your international footprint do broader ex U S. Commercial plans for your pipeline assets and to what degree do you anticipate remaining U S focused in the long term.

Speaker Change: So I assume there will be some impact right going forward at least in the front half of the year.

Speaker Change: Yeah, Larry Thanks for that question.

Speaker Change: I think your assessment is right that this year 2025, it's going to be more reflective of the price dynamics as we anniversary through the strategic contracting.

Speaker Change: I think our focus really is U S base right now.

Justin Walsh: North Sea.

Justin Walsh: And once we close on life growing dealer imaging it will give us a much stronger international footprint.

Speaker Change: With art with our partners.

Speaker Change: And so the normal seasonality, if you will isn't necessarily going to be reflective within the <unk> franchise, we will see seasonality.

Justin Walsh: We certainly want to stop relying on out licensing our assets.

Speaker Change: Normally see with a definitive for instance.

Justin Walsh: I think we're going to look very carefully at expanding in.

Speaker Change: But.

Speaker Change: As we look into 2026 as we anniversary through yes, we do have a sense of of.

Justin Walsh: The other markets, particularly the EU. However, we're not going to do a greenfield exercise, where we're going to pull a lot of money into something that hopefully can fill it up so it is going to be opportunity based and I think the stronger portfolio.

Speaker Change: Bringing those sort of foundational products and in clarifying definitive back to more of a seasonally cadenced.

Speaker Change: Well if you work.

Justin Walsh: Gives us a real reason to be there.

Speaker Change: Of.

Speaker Change: Of revenue stream.

Justin Walsh: But as we look at the company today, where U S focused.

Speaker Change: Maybe just to add Larry on this specific kind of pricing dynamics in the second half of 'twenty four.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

We did see sequential declines if you look at the first half of 'twenty for pricing and you look at the second half of 'twenty for pricing from an actual realized we did see a decline now.

Speaker Change: Our next question comes from the line of Anne <unk> from William Blair.

Speaker Change: Hello, Thanks for taking our questions. So.

Speaker Change: That's with the overall raising prices and others to help to offset some of those but that will normalize as Bob has mentioned as we get to the second half of 'twenty five because those year over year comps are now included.

Speaker Change: I'm curious if you could comment on your strategy in building the data set the highlights the competitive differentiation for MPC CPU 40 in that $64 94.

Speaker Change: We did take a mid single digit price increase at the beginning of 'twenty four we highlighted that we did the same slightly earlier in 25 years.

Speaker Change: About 46 94.

Speaker Change: As you get ready for the regulators touring submissions of these two assets. Thank you.

Speaker Change: Yes, it's a great question and I think.

Speaker Change: Thank you.

Speaker Change: There was the annual amyloid conference in Puerto Rico in January.

Speaker Change: One moment for our next question.

Speaker Change: Our next question comes from the line of Justin Walsh from Jones trading.

Speaker Change: Because it seems like ages ago.

Speaker Change: And the quality and amount of information on MK 60 to 40.

Speaker Change: Hi, Thanks for taking the question you noted <unk> is expected to expand your international footprint do broader ex U S. Commercial plans for your pipeline assets and to what degree do you anticipate remaining U S focused in the long term.

Speaker Change: Really quite substantial and data coming out of the hedge study in Pittsburgh.

Speaker Change: Which is a federally funded trial, where basically they are comparing all the tau agents and all the tracers in.

Speaker Change: I think our focus really is U S base right now.

Speaker Change: Hey.

Speaker Change: Demonstrated a significant advantage from 60 to 40 over any of the other tower tracers.

Speaker Change: North Sea and once we close on life <unk> imaging it will give us a much stronger international footprint.

Speaker Change: Whether they are in development or on the market today.

Speaker Change: So we feel that <unk> 60 to 40 is already recognized.

Speaker Change: We certainly want to stop relying on out licensing our assets.

Speaker Change: As an extraordinary asset for its ability to detect early Tau tangles.

Speaker Change: So I think we're going to look very carefully at expanding into the other markets, particularly the EU. However, we're not going to do a greenfield exercise, we're going to pull a lot of money into something of that hope we can fill it up so.

Speaker Change: And the evidence of that is very clear as well because turnover.

Speaker Change: 100 clinical trials right now.

Speaker Change: Most of the vast majority academic but we have.

Speaker Change: Going to be opportunity based and I think the stronger portfolio gives us a real reason to be there.

Speaker Change: Some real interesting partnerships.

Speaker Change: Already in place and developing with major pharma like J&J, like Merck and others and Roche to really be the diagnostic agent for their assets in development and we're very excited about that.

Speaker Change: But as we look at the company today, where U S focused.

Speaker Change: Thank you.

Speaker Change: One moment for our next question.

Speaker Change: <unk>, a little bit further behind but again NAV as a beta amyloid is seeming to shape up quite similarly to MK and its ability to detect very early or low center load counts.

Speaker Change: Our next question comes from the line of Andy Zhang from William Blair.

Andy Zhang: Hello, Thanks for taking our question so.

Speaker Change: I'm curious if you could comment on your strategy in building the data set the highlights.

Speaker Change: And I might add both of these agents, while not as convenient as a blood test.

Speaker Change: The competitive differentiation for MPC, CPU, 40, and $64 94.

Speaker Change: It may turn out to be.

Speaker Change: More sensitive than a blood test.

Speaker Change: So about 46 94.

Speaker Change: We're certainly seeing that pan out right now with MK 60 to 40 that doesn't mean it would ever replace it because a blood test is inexpensive and so cheap however, looking at some data versus P Tau and MK 60 to 40.

Speaker Change: As you get ready for the regulatory submissions of two assets. Thank you.

Speaker Change: Yes, it's a great question and I think.

Speaker Change: There was the annual amyloid conference in Puerto Rico in January.

Speaker Change: The tracers have a distinct advantage right now our tracers anyway.

Speaker Change: Because it seems like ages ago.

Speaker Change: Thanks.

Speaker Change: And the quality and amount of information on MK 60 to 40.

Speaker Change: Okay.

Speaker Change: Thank you one.

Speaker Change: One moment for our next question.

Speaker Change: It was really quite substantial and data coming out of the hedge study in Pittsburgh.

Speaker Change: Yeah.

Speaker Change: Our next question comes from the line of Jon Vander motion from Zacks.

Speaker Change: Which is a federally funded trial, where basically they're comparing all the tau agents and all the tracers in a day.

Speaker Change: Great. Thank you and good morning, as you mentioned before you acquired two assets from radio radio <unk> and that was the 24, 3% and 24 four.

Speaker Change: Demonstrated a significant advantage from 60 to 40 over any of the other tower tracers.

Speaker Change: First question is.

Speaker Change: Whats the are those completely under your control right now and then the second part is.

Speaker Change: Whether they are in development or on the market today.

Speaker Change: So we feel that <unk> 60 to 40 is already recognized.

Speaker Change: You have a significant investment in them as well and they have a pretty large portfolio and our presence in Australia does anything else look attractive at.

Speaker Change: As an extraordinary asset for its ability to detect early Tau tangles.

Speaker Change: Does that company for you.

And the evidence of that is very clear as well because turnover.

Speaker Change: Yes, and good morning.

100 clinical trials right now.

Speaker Change: Number one the answer to a 100% control the assets is yes.

Speaker Change: Most of the vast majority academic but we have.

Speaker Change: And number two the whole company does look interesting they've got a very nice portfolio in development.

Speaker Change: Some real interesting partnerships.

Speaker Change: But our significant investment is really not that big in reality.

Speaker Change: Already in place and developing with major pharma.

Speaker Change: Like J&J, like Merck and others and Roche to really be the diagnostic agent for their assets in development and we're very excited about that.

Speaker Change: It's kind of a foot in the door to stay close to them and support them and we're going to stay close to them. We like the management team. We like what they are trying to do and we want them to be successful at it.

Speaker Change: <unk> is a little bit further behind but again NAV as a beta amyloid is seeming to shape up quite similarly to MK and its ability to detect very early or low center load counts.

Speaker Change: More reasons evolves to partner will continue to do so, but we are leveraging their capabilities right now as we March along with <unk> and get it into the clinic.

Speaker Change: And I might add both of these agents, while not as convenient as a blood test.

Speaker Change: Thank you one moment for our next question.

Speaker Change: It may turn out to be.

Speaker Change: More sensitive than a blood test.

Speaker Change: Our next question comes from the line of Kemp Oliver from Brookline capital markets.

We're certainly seeing that pan out right now with MK 60 to 40 that doesn't mean it would ever replace it because a blood test is inexpensive and so cheap however, looking at some data versus P Tau and MK 60 to 40.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Wanted to ask about PNG 200 to in the context.

Speaker Change: The tracers have a distinct advantage right now our tracers anyway.

Speaker Change: The Pea SMA for final hazard ratio coming out at nine one.

Speaker Change: Thanks.

Speaker Change: No we're still waiting for.

Speaker Change: Thank you one moment for our next question.

Speaker Change: Your final HR data, but it strikes me that with that as the competitive bar debt.

Speaker Change: Okay.

Speaker Change: Our next question comes from the line of John vendor motion from Zacks.

Speaker Change: 200 <unk> prospects.

Speaker Change: Pretty.

Speaker Change: Great. Thank you and good morning, as you mentioned before you acquired two assets from radio radio foreign <unk> and that was the 24 to $3 24.

Speaker Change: <unk> now.

Speaker Change: Yes. Thanks for the question I think when you look at the population.

Speaker Change: Pre chemo for 2000, and <unk> as well as prolific toe.

Speaker Change: First question is.

Speaker Change: Whats the are those completely under your control right now and then the second part is.

Speaker Change: We were under dosed at our trial.

Speaker Change: The cycles, we're a little further apart.

Speaker Change: You have a significant investment in them as well and they have a pretty large portfolio and our presence in Australia does anything else look attractive.

Speaker Change: We had a suboptimal overall survival.

Speaker Change: Hazard ratio, which may not improve so while the safety the efficacy of the product is there from our ability to get it approved by the FDA will not that confident so we're going to just wait for the study to read out see where we go and then determined if we have a play.

Tony: Tony for you.

Tony: Yes, good morning.

Speaker Change: Number one the answer to a 100% control the assets is yes.

Tony: And number two the whole company does look interesting they've got a very nice portfolio in development.

Tony: But our significant investment is really not that big in reality.

Speaker Change: So we're just going to learn as we go and see how it goes but right now.

Tony: It's kind of a foot in the door to stay close to them and support them and we're going to stay close to them. We like the management team, we like what they're trying to do and we want them to be successful at it.

Speaker Change: We are not expecting an FDA approval for <unk> in the near future.

Thank you one moment for our next question.

Tony: More reasons evolves to partner, we will continue to do so but we are leveraging their capabilities right now as we March along with <unk> and get it into the clinic.

Speaker Change: Our next question comes from the line of Richard <unk> from <unk> Securities.

Speaker Change: Oh, hi, Thank you for taking the follow up.

Tony: Thank you.

Speaker Change: I wanted to ask.

Speaker Change: One moment for our next question.

Speaker Change: The low single digit to mid single digit Polaris <unk> Guide growth guide can.

Speaker Change: Our next question comes from the line of Ken Oliver from Brookline capital markets.

Speaker Change: Can you just talk to what your underlying market growth assumption is.

Speaker Change: Okay.

Speaker Change: Or what the what the trend will look like in 'twenty five to get to get there.

Speaker Change: Thank you.

Speaker Change: Wanted to ask about PNG 200 to in the context.

Speaker Change: So I think rich we continue to see growth potential in the PMA pet market certainly double digit growth when we see that.

Speaker Change: The PFS on May four final hazard ratio coming out at nine one.

Speaker Change: We're still waiting for.

Speaker Change: We are very focused on maintaining our leadership in our share position I think what youre seeing is the natural seasonality across quarters that Bob has alluded to many times before and then the gross to net compression given the roll in of our strategic partnerships and so the overall market.

Speaker Change: Your final HR data, but it strikes me that with that as the competitive bar debt.

Speaker Change: 202 as prospects May look pretty.

Speaker Change: <unk> now.

Speaker Change: Yes. Thanks for the question I think when you look at the population pre.

Speaker Change: Pre chemo for 2000, and <unk> as well as prolific toe.

Speaker Change: <unk> strong we are focused on maintaining our revenue share.

Speaker Change: We were under dosed at our trial.

Going forward and maintaining Polaris high as the clear market leader and so.

Speaker Change: The cycles, we're a little further apart and we had a suboptimal overall survival.

Speaker Change: Growth will not be sequentially. The same every year or even every quarter as additional data comes out and so we believe in the long term potential and.

Speaker Change: Hazard ratio.

Speaker Change: You may not improve so while the safety the efficacy of the product is there from our ability to get it approved by the FDA will not that confident so we're going to just wait for the study to read out see where we go and then determined if we have a play.

Speaker Change: And we believe that clarify will maintain its leadership and its revenue share position.

Paul: Yes, the only thing I would add to that Paul is that obviously that the guidance is.

Paul: We're trying to do it on a net basis because thats. What ultimately is gets what gets recorded and we're really pleased that we are growing their franchise.

Speaker Change: So we're just going to learn as we go and see how it goes but right now.

Paul: Franchise with a very nice margin profile is going to help us to generate that $550 to $600 million of free cash flow.

Speaker Change: We are not expecting an FDA approval for <unk> in the near future.

Paul: Which has now.

Speaker Change: Thank you one moment for our next question.

Paul: <unk> been telling people that it was about 125 on average that number goes up to about $140 million in average could you say that again.

Speaker Change: Our next question comes from the line of Richard <unk> from <unk> Securities.

Paul: $550 to $600 million of free cash flow. This year. This year. So I mean, that's ultimately the benefit because thats going to help us to drive our long term growth profile of the company.

Speaker Change: Oh, hi, Thank you for taking the follow up I guess.

Speaker Change: I wanted to ask.

Speaker Change: The low single digit to mid single digit Polaris <unk> Guide growth guide can.

Paul: Thank you one moment for our next question.

Speaker Change: Can you just talk to what your underlying market growth assumption is.

Speaker Change: Or what the what the trend will look like in 'twenty five to get to get there.

Speaker Change: Our next question comes from the line of David <unk> from citizens JMP.

Paul: Hey, good morning, I apologize I've been bouncing around a little but.

Speaker Change: So I think which we continue to see growth potential in the PMA pet market certainly double digit growth when we see that.

Speaker Change: I thought I heard a comment earlier on that.

Paul: Sustained double digit growth.

Paul: Begin again in 2026.

Speaker Change: We are very focused on maintaining our leadership and our share position I think what youre seeing is the natural seasonality across quarters that Bob has alluded to many times before and then the gross to net compression given the roll in of our strategic partnerships and so the overall market.

Speaker Change: Just wondering is that based on sort of the current core clarify infinity or.

Speaker Change: Are there some assets in the pipeline there that youre comfortable with that will be contributing by then and if so could you maybe point to which ones.

Speaker Change: Would deliver that kind of profile. Thank you.

Speaker Change: Yes, no great question and I'm glad you asked it so we certainly anticipate Polaris <unk> to lead the way and definitive Theres No question in our mind there at this time.

Speaker Change: <unk> strong we are focused on maintaining our revenue share.

Speaker Change: Going forward and maintaining Polaris high as the clear market leader and so.

Speaker Change: Growth will not be sequentially. The same every year or even every quarter as additional data comes out and so we believe in the long term potential.

Speaker Change: Also we have 23 in the pipeline and.

Speaker Change: And pending closing.

Speaker Change: <unk>.

Speaker Change: LMI and evergreen Vice molecular imaging, we will look to add new receipt, which we're very excited about and actively the third elastic pair.

Speaker Change: And we believe that clarify will maintain its leadership and its revenue share position.

Speaker Change: Yes, the only thing I would add to that Paul is that obviously that the guidance is.

Paul: Trying to do it on a net basis because thats. What ultimately is gets what gets recorded and we're really pleased that we are growing their franchise. It's a $1 billion franchise with a very nice margin profile is going to help us to generate that $550 to $600 million of free cash flow.

Speaker Change: <unk> to 'twenty, three which is in our pipeline. So we're looking at potentially three brand new launches next year that will lead to a growth profile. The addition of <unk> and that will pop us into double digit growth, but I want to underscore led by Polaris Sai.

Speaker Change: Which has now.

Speaker Change: <unk> been telling people that it was about 125 on average that number goes up to about $140 million in average could you say that again.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program you may disconnect and have a wonderful day.

Speaker Change: $550 to $600 million of free cash flow. This year. This year. So I mean, that's ultimately the benefit because thats going to help us to drive our long term growth profile of the company.

Speaker Change: Thank you one moment for our next question.

Speaker Change: Our next question comes from the line of David <unk> from citizens JMP.

Speaker Change: Hey, good morning, I apologize I've been bouncing around a little but.

Speaker Change: I thought I heard a comment earlier on that.

Speaker Change: Sustained double digit growth.

Speaker Change: Begin again in 2026.

Speaker Change: Just wondering is that based on sort of the current core clarify infinity or.

Speaker Change: Are there some assets in the pipeline there that youre comfortable with that will be contributing by then and if so could you maybe point to which ones.

Speaker Change: Would deliver that kind of profile. Thank you.

Speaker Change: Alright.

Speaker Change: Great question and I'm glad you asked it so we certainly anticipate Polaris Sai to lead the way and definitive Theres No question in our mind there at this time.

Speaker Change: Also we have 23 in the pipeline and.

Speaker Change: And pending closing.

<unk>.

Speaker Change: LMI and evergreen Vice molecular imaging, we will look to add new receipt, which we're very excited about and actively the third elastic pair.

Speaker Change: <unk> to 'twenty, three which is in our pipeline. So we're looking at potentially three brand new launches next year that will lead to a growth profile. The addition of <unk> and that will pop us into double digit growth, but I want to underscore led by Polaris Sai.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Ladies and gentlemen, there are no further questions at this time. Thank you for participating in today's conference. This concludes the program you may disconnect and have a wonderful day.

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