Q4 2023 Lantheus Holdings Inc Earnings Call
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Operator: Good morning. Welcome to Lantheus's fourth quarter 2023 and full year 2023 conference call. This is your operator for today's call. Please note that all lines have been placed on mute to prevent any background noise. This call is being recorded for replay purposes.
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Good morning, welcome to do anything its fourth quarter 2023, and full year 2023 conference call.
This is your operator for today's call.
Please note that all lines have been placed on mute to prevent any background noise.
This call is being recorded for replay purposes.
Operator: A replay of the webcast will be available in the Investors section of the company's website approximately two hours after the completion of the call and will be archived for at least 30 days. I'd now like to turn the call over to your host for today, Mark Kinarney, Vice President of Investor Relations.
A replay of the webcast will be available in the investors section of the company's website approximately two hours. After the completion of the call and will be archived for at least 30 days.
I'd now like to turn the call over to your host for today, Mark <unk>, Vice President of Investor Relations Mark.
Mark Kinarney: Thank you. Good morning, and welcome to today's call. With me today are Mary Ann Heino, our CEO; Brian Markeson, current Executive Chair of the Board and incoming CEO; Paul Blanchfield, our President; and Bob Marshall, our Chief Financial Officer. We'll begin the call with Marian's introductory remarks, followed by operational and strategic updates from Paul and Brian. Bob will cover our 2023 financial results and financial guidance for 2024. Mary Ann will provide closing remarks, and then we will open the call for Q&A.
Thank you good morning, and welcome to today's call with me today are Mary Anne Heino, Our CEO, Brian Marcussen current executive Chairman the board and incoming CEO Bob.
Paul Blanchfield, our president and Bob Marshall, Our Chief Financial Officer.
We will begin the call with Marriott's introductory remarks, followed by operational and strategic updates for Paul and Bryan.
Bob will cover our 2023 financial results and financial guidance for 2024.
Maryann will provide closing remarks, and then we will open the call for Q&A.
Mark Kinarney: This morning, we issued a press release, which was filed with the Securities and Exchange Commission under Form 8K, reporting our fourth quarter and full year 2023 results. The release and today's slide presentation are in the investor section of our website at lantheus.com. Any comments made during our call could include forward-looking statements, but actual results may differ materially from these statements due to a variety of risks and uncertainties.
This morning, we issued a press release, which was furnished to the Securities and Exchange Commission under form 8-K reporting our fourth quarter and full year 2023 results.
The release and today's slide presentation on the investors section of our website Atlantica is dot com.
Any comments made during our call credits, which forward looking statements.
Actual results may differ materially from these statements due to a variety of risks and uncertainties.
Mark Kinarney: Please note that we assume no obligation to update our commentary or any forward-looking statements except as required by applicable law, even if actual results or future expectations change materially. Please refer to our SEC filings for a detailed discussion of these risks and uncertainties. Discussions during this call will also include certain non-GAAP financial measures.
Please note that we assume no obligation to update or commentary or any forward looking statements, except as required by applicable law, even if actual results or future expectations change materially.
Please refer to our SEC filings for a detailed discussion of these risks and uncertainties.
Discussions during this call will also include certain non-GAAP financial measures reconciliation of these measures to the most directly comparable GAAP financial measures is also included on the investors section of our website.
Mary Anne Heino: Reconciliation of these measures to the most directly comparable gap financial measures is also included in the investor section of our website. It is my pleasure to now turn the call over to our CEO, Mary Ann. Thank you, Mark, and good morning, everyone. Before we get started, I want to welcome Brian Markeson as the company's new chief executive officer, effective March 1st. It was so important to the Lantheus board and me that our new CEO be able to drive forward the great work we have done. And in Brian, we have an experienced executive who intimately understands Lantheus, our strategy, and our industry. He brings decades of leadership experience in life science and deep expertise in oncology and neurology that will be essential to delivering on our strategic priorities. Welcome, Brian.
It is my question to now turn the call over to our CEO Mary Anne Thank.
Thank you Mark and good morning, everyone before we get started I want to welcome Brian Mark as soon as the company's New Chief Executive Officer effective March 1st It was so important to the land is board and me that our new CEO to be able to drive forward. The great work, we have done and then Brian we have an experienced executive intimately.
And Atlanta is our strategy.
He brings decades of leadership experience in lifestyle and deep expertise in oncology and neurology that will be essential to delivering on our strategic priority welcome Brian.
Mary Anne Heino: 2023 was another stellar year at Lantheus, delivering record revenues and earnings in cash flows, bolstering our position as a leading radiopharmaceutical-focused company. I'm particularly proud that our products were used to impact the lives of more than 6 million patients and their families in 2023, a testament to our purpose to find, fight, and follow disease to deliver better patient outcomes. For full year 2023, we reported revenue of approximately $1.3 billion, representing year-over-year growth of 39%, in line with what the company pre-announced in early January.
2023 was another stellar year Atlanta, delivering record revenues earnings and cash flows bolstering our position as a leading radiopharmaceutical focused company.
Particularly proud that our products were used to impact the lives of more than 6 million patients and their families. In 2023, a testament to our purpose to find fight and follow disease to deliver better patient outcomes.
For full year 2023, we reported revenue of approximately $1 3 billion representing year over year growth of 39% in line with what the company pre announced in early January.
Mary Anne Heino: This growth was primarily driven by PolariFi and DFINITY, both of which delivered strong performance of over 61% and 14% growth year over year, respectively, continuing solid momentum for 2024. Polarify continues to grow, with the potential to reach a billion dollars in sales this year, and remains the clear market leader, offering a differentiated value proposition that, together with our operational excellence, gives us confidence that Polarify will remain the number one PSMA PET imaging agent for prostate cancer patients, even amidst increasing competition and potential transitional paths to expiry. DFINITY, as well, delivered solid growth and remains the ultrasound-enhancing agent of choice. Beyond our existing commercial diagnostics portfolio, we also made significant advancements across our radiopharmaceutical pipeline for both late and earlier stage oncology therapeutics, as well as oncologic and non-oncologic diagnostics. In mid-December, we reported positive top-line phase 3 splash results for PNT2002. Our investigational PSMA targeted radiotherapeutic in development for the treatment of patients with metastatic castration-resistant prostate cancer, or MCRP, says
This growth was primarily driven by clarify independent eight both of which delivered strong performance up over 61% and 14% growth year over year, respectively, continuing solid momentum for 2024.
<unk> continues to grow with the potential to reach $1 billion in sales this year and remains the clear market leader operating offering a differentiated value proposition that together with our operational excellence give us confidence that <unk> will remain the number one guesstimate pet imaging agent for prostate cancer patients.
EBIT admit increasing competition and potential transitional pass through expiry.
This entity as well delivering solid growth and remains the ultrasound enhancing agent of choice.
Beyond our existing commercial diagnostics portfolio. We also made significant advancements across our radiopharmaceutical pipeline for both late and earlier stage oncology therapeutics as well as oncologic and non oncology diagnostics.
In mid December we reported positive top line phase III results for PMT to zero zero to our investigational <unk> targeted radiotherapeutic in development for the treatment of patients with metastatic castration resistant prostate cancer or CRP C. Diff.
Mary Anne Heino: The SPLASH trial met its primary endpoint, demonstrating a statistically significant 29% reduction in the risk of radiographic progression or death. We continue to review the SPLASH study results and are specifically awaiting more mature overall survival data, which we currently expect later this year. For PNT2003, our product candidate for the treatment of neuroendocrine tumors, we filed, and the FDA accepted, our abbreviated new drug application, or ANDA. As expected, Novartis filed a patent infringement lawsuit which triggered a potential 30-month stay under the Hatch-Waxman Act.
This last trial met its primary endpoint, demonstrating a statistically significant 29% reduction in the risk of radiographic progression or death.
We continue to review the Splash study results and our specifically awaiting more mature overall survival data, which we currently expect later this year.
For PMT to 003, our product candidate for the treatment of neuroendocrine tumors, we file and the FDA accepted our abbreviated new drug application or <unk>.
As expected Novartis filed a patent infringement lawsuit, which triggered a potential 30 months day under the Hatch Waxman Act.
Mary Anne Heino: We are very excited about the process of commercializing this important radio equivalent to Luta Terra and look forward to a potential launch in 2026. As the leading radiopharmaceutical-focused company, we continually explore opportunities to grow and expand our pipeline. We are particularly focused on identifying the targets and complementary isotopes that are best suited to treat certain diseases.
We are very excited about the prospect of commercializing this important radio equivalent to loot the terror and look forward to a potential launch in 2026.
As the leading radiopharmaceutical focused company, we continually explore opportunities to grow and expand our pipeline.
We are particularly focused on identifying the targets and complementary isotopes that are best suited to treat certain diseases. As an example, we recently announced a strategic partnership with prospective <unk> therapeutics that provides us with options to add radio buy again therapy, RFP asset to our pipeline and expand into outbid therapeutics.
Mary Anne Heino: As an example, we recently announced a strategic partnership with Prospective Therapeutics that provides us with options to add radioligand therapy or RLT assets to our pipeline and expand into Alpha Therapeutics. If exercised, these options will allow us to diversify our RLT pipeline with Prospective's LED212-labeled product candidate, an alpha RLT for the treatment of neuroendocrine tumors, currently in Phase I-IIa development. In addition, we have an opportunity to co-develop perspective-led 212 isotope-based alpha-generating therapy candidates for prostate cancer. We are also investing in our innovative diagnostic pipeline. We continue to develop MK6240, an F18-based tau PET tracer under development for the detection of tau tangles in patients with Alzheimer's disease.
If exercised these options will allow us to diversify our RFP pipeline with respect. This led to 12 labeled product candidate and Alpha <unk> for the treatment of neuroendocrine tumors currently in phase <unk> development.
In addition, we have an opportunity to co develop perspectives led to 12 isotope based alpha generating therapy candidate for prostate cancer.
We're also investing in our innovative diagnostic pipeline.
We continue to progress MK 60 to 40.
18, based Tau pet tracer under development for the detection of Tau tangles in patients with Alzheimer's disease to date. It is being used in more than 90 clinical trials, either as a staging tool or as a biomarker to identify patients to be enrolled in trials of alzheimer disease therapeutic candidates.
Mary Anne Heino: To date, it is being used in more than 90 clinical trials, either as a staging tool or as a biomarker to identify patients to be enrolled in trials of Alzheimer disease therapeutic candidates. We are finalizing the regulatory path to bring this exciting product candidate to market as a commercially approved agent. Similar to how PSMA PET imaging has transformed staging and patient selection for prostate cancer, we believe that cow-based PET imaging agents like MK6240 can play a similar role in staging and patient selection for Alzheimer's disease treatment.
We are finalizing the regulatory path to bring this exciting product candidate to market as a commercially approved inger.
Similar to help you to make pet imaging has transformed staging and patient selection for prostate cancer. We believe that Tau based pet imaging agents like MPA 60 to 40 can play a similar role in staging and patient selection for Alzheimer's disease treatment.
Paul Blanchfield: With that, I'll now turn the call over to Paul. Thank you, Mary Ann, and good morning. Our fourth-quarter results demonstrated clear market leadership, operational excellence, and continued growth of the overall PSMA PET imaging market. We are pleased with Polarify's success and the impact it has had on the lives of those living with prostate cancer, including having been utilized for the diagnosis and staging of more than 300,000 patients since launch. Polarify generated net sales of approximately $230 million in the fourth quarter and $851 million in 2023, up over 40% and 60%, respectively, from the prior year period. Both quarterly and full-year growth were driven by increasing utilization of PSMA PET with Polarify at existing customers, complemented by our efforts to expand access through our distribution network to meet this growing demand. We attribute our continued success to three primary factors. Clinical differentiation, commercial differentiation, and operational expertise. Clinically, we believe Polarify offers the best combination of our proprietary PSMA-targeted ligand and F18 isotopes. Our registrational trials demonstrated high positive predictive value and high reader agreement, providing clinicians confidence in the accuracy and consistency of image interpretation and ultimately in their patient management decisions.
With that I'll now turn the call over to Paul.
Thank you Mary Ann and good morning.
Our fourth quarter results demonstrated clear market leadership operational excellence and continued growth of the overall P SMA pet imaging market.
We are pleased with Polaris <unk> success and the impact that has made on the lives of those living with prostate cancer, including having been utilized for the diagnosis and staging of more than 300000 patients since launch.
Polaris <unk> generated net sales of approximately $230 million in the fourth quarter and $851 million in 2023 up over 40% and 60% respectively from the prior year periods.
Both quarterly and full year growth were driven by increasing utilization of <unk> pet with Polaris.
<unk> customers complemented by our efforts to expand access through our distribution network to meet this growing demand.
We attribute our continued success to three primary factors clinical differentiation commercial differentiation and operational excellence.
Clinically we believe clarify offers the best combination of our proprietary P SMA targeting ligand and F 18 isotopes.
Our registrational trials demonstrated a high positive predictive value and high reader agreement, providing clinicians confidence in the accuracy and consistency of image interpretation and ultimately in their patient management decisions.
Paul Blanchfield: Commercially, Polarify is the only PSMA imaging agent that is widely available through a diverse F-18 distributor supply network, ensuring convenient and reliable supply. In addition, more than 90% of covered lives have access to PSMA Pets with Polarify. Operationally, we continue to grow Polarify and maintain our market leadership in the PSMA diagnostic market through our educational and promotional efforts led by the industry's largest customer focus. We also offer a best-in-class customer experience that enables health care providers and patients to access Polarify with a 98% on-time, in-fold dose delivery. To ensure Polarify remains the number one utilized PSMA PET imaging agent, we are actively working to mitigate the impact of Polarify's potential transitional pass-through expiration at the end of 2024.
Commercially Polaris <unk> is the only <unk> imaging agent that is widely available through a diverse <unk>.
<unk> distributor supply network, ensuring convenient and reliable supply and.
In addition, more than 90% of covered lives have access to PMA path with clarifying.
Operationally, we continue to grow clarify and maintain our market leadership in the <unk> diagnostic market through our educational and promotional efforts led by the industry of largest customer focused team.
We also offer a best in class customer experience that enables healthcare providers and patients to access clarify with a 98% on time in full dose on the free right.
To ensure Polaris <unk> remains the number one utilized PMA pet imaging agent. We are actively working to mitigate the impact of Polaris <unk> potential transitional pass through exploration at the end of 2024, we.
Paul Blanchfield: We have already taken steps to ensure we remain the market leader in 2025 and beyond and have and continue to build long-term strategic partnerships with select customers to ensure they have access to and preferably choose Polarify as their PSMA pet agent of choice. We are fiercely committed to ensuring Polarify is available for patients, continues to grow, and remains the market leader. Finally, we continue to work with the Centers for Medicare and Medicaid Services, or CMS, to create separate payments for radiopharmaceutical diagnostics, while also advocating for the FIND Act to ensure health equity for patients seeking access to innovative radiopharmaceutical diagnostics, including Polarify. To support long-term growth, we are exploring the clinical utility of Polarify in additional patient populations. We recently enrolled the first patient in the MIRROR study, designed to determine whether polarized PSMA PET imaging can accurately detect the presence or absence of prostate cancer outside of the prostate gland in patients staged as favorable intermediate risk, and importantly, how it can change intended management.
We have already taken steps to ensure we remain the market leader in 2025 and beyond and have and continue to build long term strategic partnerships with select customers to ensure they have access to and preferably choose Polaris <unk> as their PSA make pet agent of choice.
We are fiercely committed to ensuring Polaris is available for patients continues to grow and remains the market leader.
Finally, we continue to work with the centers for Medicare and Medicaid services or CMS to create separate payment for radiopharmaceutical diagnostics. While also advocating for the find out to ensure health equity for patients seeking access to innovative radiopharmaceutical diagnostics, including Polaris Sai.
To support long term growth, we are exploring the clinical utility of Polaris <unk> in additional patient populations. We recently enrolled the first patient in the mirror study designed to determine whether Polaris <unk> pet imaging can accurately detect the presence or absence of prostate cancer outside of the <unk>.
The state Glenn in patient staged as favorable intermediate risk and importantly, how it can change intended management.
Paul Blanchfield: As we shared earlier this year, we see significant growth opportunity for PSMA PETA. We believe the current addressable market for PSMA PET is about 445,000 scans or $2 billion and could grow to a total addressable market of approximately 700,000 scans or more than $3 billion by 2050. To realize this, we anticipate the expansion of PSMA PET imaging into the favorable intermediate population supported by the mirror study and other real-world evidence.
As we shared earlier this year, we see significant growth opportunity for PMA pet imaging.
We believe the current addressable market for <unk> is about 445000 scans or $2 billion.
And could grow to a total addressable market of approximately 700000 scans for more than $3 billion by 2029.
To realize this we anticipate the expansion of <unk> pet imaging into the favorable intermediate population supported by the mirror study and other real world evidence.
Paul Blanchfield: We anticipate PSMA therapeutics, both RLT and other modalities, will move into earlier lines of therapy, including both pre-chemo, MCRPC, and hormone-sensitive prostate care, which would increase the need for PSMA PET. Finally, we expect the incidence and prevalence of prostate cancer to grow 2-3% per year. As such, we believe there is a significant opportunity for PSMA Pet to continue to grow and for Polarify to maintain its market share. In our microbubble business, DFINITY maintained its strong momentum with full year 2023 net sales of approximately $280 million, up 14% year over year. The drivers of success for this product continue to be its clinical and commercial value proposition supported by our operational expertise. Clinically, DFINITY delivers high-resolution echocardiograms that improve cardiac diagnosis and patient management and has a proven safety profile across broad patient populations.
We anticipate <unk> therapeutics, both royalty and other modalities will move into earlier lines of therapy, including both pre chemo and the RPC and hormone sensitive prostate cancer, which would increase the need for PMA pet imaging.
Finally, we expect the incidence and prevalence of prostate cancer to grow 2% to 3% per year.
As such we believe there is a significant opportunity for PMA path to continue to grow and for Polaris <unk> to maintain its market leadership.
And our Microbubble business definitive maintained its strong momentum with full year 2023, net sales of approximately $280 million.
14% year over year.
The drivers of success for this product continued to be its clinical and commercial value proposition supported by our operational excellence.
Politically definitive delivers high resolution echocardiograms that improve cardiac diagnosis and patient management and has a proven safety profile across broad patient populations.
Paul Blanchfield: Commercially, DFINITY remains the clear market leader as the most utilized, extensively studied, and trusted ultrasound-enhancing agent in the U.S., and is widely available, with more than 95% of covered lives having access. Operationally, we have increased production of DFINITY at our Lantheus manufacturing facility, which allows for enhanced supply chain redundancy, improved flexibility, and reduced costs. These improvements, along with our continued efforts to drive demand for DFINITY, will ensure continued brand success. Switching now to our pipeline, in December 2023, we announced positive top-line results from the Phase 3 SPLASH trial of PNT2002, in which the study met its primary end. We continue to analyze the results and expect more mature overall survival data later this year, prior to the potential submission of an NDA. We also plan to present the SPLASH results at a future medical meeting. PNT2003 is an investigational RLT targeting somatostatin receptors with non-carrier added lutetium with the potential to treat gastroenteropancreatic neuroendocrine tumors, or GEPNPs, as a radio equivalent to lutethera.
Commercially definitive remains the clear market leader as the most utilized extensively studied and a trusted ultrasound enhancing agent in the U S and is widely available with more than 95% of covered lives having access to definitive.
Operationally, we have increased production of definitive at our <unk> manufacturing facility, which allows for enhanced supply chain redundancy improved flexibility and reduced cost fees.
These improvements along with our continued efforts to drive demand for definitive will ensure continued brand success.
Switching now to our pipeline in December 2023, we announced positive topline results from the phase III Splash trial PMT to 002, and what's the study met its primary endpoint.
Continue to analyze the results and expect more mature overall survival data later this year.
Meyer to the potential submission of an NDA.
We also plan to present, the splash results at a future medical conference.
PMT to 003 is an investigational or LP targeting somatostatin receptors with non carrier added the TCM with the potential to treat gastro enteral pancreatic neuroendocrine tumors or <unk> nets, as a radio equivalent to Lucas era.
Paul Blanchfield: Our end of filing with the FDA for PNT2003 underscores our commitment to making this therapy accessible, furthering our purpose to improve patient outcomes through radiotherapeutics and diagnosis. Based on public information, we believe Lantheus is the first applicant to have filed a substantially complete ANDA for Lutetium-177 dota 2. We estimate that P&T 2003 has a current addressable U.S. market of approximately $1 billion that is expected to expand to over $5 billion by 2020. In addition to our late-stage oncology pipeline, we have a number of earlier-stage assets, including the partnership with Prospective Therapeutics we recently announced. I'll now hand it over to Brian, who will speak briefly about this latest opportunity. Thank you, Paul, and good morning, everyone.
Our NDA filing with the FDA for PMT to 003 underscores our commitment to making this therapy accessible furthering our purpose to improve patient outcomes through radio therapeutics and diagnostics.
Based on public information, we believe <unk> is the first applicant to have filed a substantially complete and the for the TCM 177, Dota Tate we.
We estimate that PMT to 003 is a current addressable U S market of approximately $1 billion.
That is expected to expand over $5 billion by 2029.
In addition to our late stage oncology pipeline, we have a number of earlier stage assets, including the partnership with prospective therapeutics, We recently announced.
I'll now hand, it over to Brian who will speak briefly about this latest opportunity.
Thank you Paul and good morning, everyone.
As Maryann and Paul both mentioned, we are excited about the prospective partnership.
Brian Markeson: As Mary Ann and Paul both mentioned, we are excited about the prospective partnership, and I want to speak a bit more about why I think it's a smart, strategic opportunity for the company going forward. Our partnership with Perspective has three components. First, we have an option to license their promising LEAD212 program in neuroendocrine tumors.
And I want to speak a bit more about why I think it's a smart strategic opportunity for the company going forward.
Our partnership with perspective has three components first we have an option to license they are promising.
Led to 12 program in neuroendocrine tumors perspective is currently enrolling patients in a phase one two a study.
Aggressive through the dose escalation phase and we expect to have a look at initial data later this year.
Brian Markeson: Perspective is currently enrolling patients in a Phase I, IIa study, progressing through the dose escalation phase, and we expect to have a look at initial data later this year. Second, we have an option to co-develop Prospectus prostate cancer assets supported by their innovative platform technology. And third, we took an equity position in the company because we believe in the science behind the lead alpha-based therapy platform and we have secured the right of first offer and last look protections for any third-party merger and acquisition transactions involving Prospective for a 12-month period. We recognize the transformative potential of Prospective Therapeutics' Alpha therapies and believe this partnership provides flexibility while preserving our capital for additional business development opportunities. We see lead 212 as one of the more promising isotopes for alpha therapy, especially when paired with Prospectus' Proprietary Chelator. We believe PROSPECTIVE's lead 212 chelator may enable it to better retain the isotope and its daughters, including bismuth-212, thereby concentrating radiation at the target tumor and reducing off-target effects.
Second we have an option to co develop prospectus prostate cancer assets supported by their innovative led platform technology.
Third we took an equity position of the company because we believe the science behind the lead Alpha based therapy platform and we have secured the right of first offer at last look protections for any third party merger and acquisition transactions involving perspective for a 12 month period we.
We recognize the transformative potential of prospective therapeutics Alpha therapies and believe this partnership provides flexibility while preserving our capital for additional business development opportunities.
We see lead to 12 is one of the more promising isotopes for alpha therapy, especially when paired with prospectus proprietary key later.
We believe perspectives led to 12 key later may enable it to better retain the isotope abbott's borders including business to 12, thereby concentrating radiation at the target tumor and reducing off harbor target effects.
This transaction aligns with our investment strategy to further expand our radiopharmaceutical pipeline with potential long term benefits.
<unk> us to gain access to innovative therapies technologies and establishing.
Collaborative partnership for sustained growth.
I will now turn the call over to Bob.
Thank you, Brian and good morning, I will provide highlights of the fourth quarter and full year 2023 financials, focusing on adjusted results unless otherwise noted.
Brian Markeson: This transaction aligns with our investment strategy to further expand our radiopharmaceutical pipeline with potential long-term benefits, allowing us to gain access to innovative therapies and technologies and establish a collaborative partnership for sustained growth. I will now turn the call over to Bob. Thank you, Brian, and good morning. I will provide highlights of the fourth quarter and full year 2023 financials, focusing on adjusted results unless otherwise noted. Revenue for the fourth quarter was $354 million, an increase of 34.5% over the prior year quarter. Revenue for the full year was $1,296,000,000, an increase of 38.6% over 2022. And, as noted in the press release, we recognized a $15 million RellaStore sales milestone achievement during Q4. Radiopharmaceutical Oncology contributed $230.6 million of sales in the quarter, up 42.8% from the prior year quarter, attributable to the continued strength of Polarify, with sales of $229.9 million, up 43.1% year-over-year.
Revenue for the fourth quarter was $354 million, an increase of 34, 5% over the prior year quarter revenue for the full year was $1 billion $2 $96 million, an increase of 38, 6% over 2022 and as was noted in the press release, we recognized a $15 million realm.
As to our sales milestone achievement during Q4.
Radiopharmaceutical oncology contributed $236 million of sales in the quarter up 42, 8% from the prior year quarter are attributable to the continued strength of clarify with sales of $229 9 million up 43, 1% year over year full year Polaris high sales totaled 850.
One 3 million an increase of 61, 4%.
Decision diagnostics revenue of $100 6 million was six 6% higher over the prior year quarter sales, a definitive were $73 1 million $14, 9% higher as compared to the prior year.
For the full year definitively contributed $279 8 million of sales an increase of 14, 2% over the prior year technology revenue was $21 5 million down 13% versus the prior year comparable that included greater opportunistic sales full year technology sales were $87 4 million down $1 <unk>.
7%.
Lastly, strategic partnership and other revenue was $22 8 million up 214, 9% over the prior year quarter, driven primarily primarily by the aforementioned relistor milestone contribution of $15 million and further bolstered by <unk> 60 to <unk> performance of $6 4 million.
Brian Markeson: Full-year Polarify sales totaled $851.3 million, an increase of 61.4%. Precision Diagnostics revenue of $100.6 million was 6.6% higher over the prior year quarter. Sales of DFINITY were $73.1 million, 14.9% higher as compared to the prior year. For the full year, DFINITY contributed $279.8 million in sales, an increase of 14.2% over the prior year. Technolite revenue was $21.5 million, down 13% versus the prior year comparable that included greater opportunistic sales. Full year Technolite sales were $87.4 million, down 1.7%.
For the full year MKS 60 to 40 contributed $21 9 million.
Relistor contributed $29 3 million, which should be removed for comparison purposes of 2024 versus 2023 revenue.
Gross profit margin for the fourth quarter was 69, 3% an increase of 251 basis points over the fourth quarter of 2022 on a similar basis full year gross profit margin was 68, 7% 221 basis points ahead of the prior year unfavorable product mix offset by <unk> investments and <unk>.
Inflationary pressures.
Operating expenses at 22, 4% of net revenue.
120 basis points higher than the prior year rate of 21, 2% and within previously guidance spending levels, particularly when adjusting revenue for the Relistor milestone incur.
Robert J. Marshall: Lastly, strategic partnership and other revenue was $22.8 million, up 214.9% over the prior year quarter, driven primarily by the aforementioned Relestore milestone contribution of $15 million, and further bolstered by MK6240's performance of $6.4 million. For the full year, MK6240 contributed $21.9 million. Relestore contributed $29.3 million, which should be removed for comparison purposes of 2024 versus 2023 revenue. Gross profit margin for the fourth quarter was 69.3%, an increase of 251 basis points over the fourth quarter of 2022 on a similar basis. Full-year gross profit margin was 68.7%, 221 basis points ahead of the prior year on favorable product mix offset by PMF investments and general inflationary pressure. Operating expenses at 22.4% of net revenue were 120 basis points higher than the prior year rate of 21.2% and within previously guided spending levels, particularly when adjusting revenue for the Relestore milestone.
Increases in operating expenses reflect reflect the investments made to support near and longer term growth initiatives across all functions of the organization as was noted throughout last year.
Other income and expense was <unk> nine.
<unk> 9 million of income and as a result of net interest income offset by a reduction of a portion of our indemnified uncertain tax positions.
Operating profit for the quarter was $165 7 million or an increase of 38, 4% over the same period prior year.
Total adjustments in the quarter were $28 3 million of expense before taxes of this amount $14, two and $11 3 million of expense is associated with noncash stock and incentive plans and acquired intangible amortization respectively.
The remainder is related to acquisition integration and other nonrecurring expenses, our effective tax rate was $26 four and 26, 1% for the full for the quarter and the full year respectively.
The resulting net reported net income for the fourth quarter was $103 4 million and $122 $7 million on an adjusted basis, an increase of 27% over the prior year period.
Fully diluted earnings per share for the fourth quarter were $1 47.
And $1 75 on an adjusted basis, an increase from the prior year of 28% on a full year basis GAAP fully diluted earnings per share were $4 65.
Robert J. Marshall: Increases in operating expenses reflect the investments made to support near and longer-term growth initiatives across all functions of the organization, as noted throughout last year. Other income and expense was $0.9 million of revenue and is a result of net interest income offset by a reduction of a portion of our indemnified uncertain tax balance. Operating profit for the quarter was $165.7 million, or an increase of 38.4% over the same period last year. Total adjustments in the quarter were $28.3 million of expense before taxes.
And $6 23 on an adjusted basis, an increase of $47.
7% over the prior year now turning to cash flow fourth quarter operating cash flow totaled $112 3 million as compared to $105 4 million in Q4, 2022 capital expenditures totaled $12 1 million $7 $3 million higher than the prior year quarter free cash flow, which we define as operating.
Cash flow less capital expenditures was $100 2 million effectively flat with the prior year period, and $258 7 million for the full year, which includes the $99 $6 million CVR payment to former <unk> shareholders last may taken together cash and cash equivalents net of restricted cash.
Robert J. Marshall: Of this amount, $14.2 and $11.3 million of expense is associated with non-cash stock and incentive plans and acquired intangible amortization, respectively. The remainder is related to acquisition, integration, and other non-recurring expenses. Our effective tax rate was 26.4% and 26.1% for the quarter and the full year, respectively.
Now stand at $713 7 million.
We have access to our $350 million Undrawn bank revolver and are very comfortable with our strong liquidity position.
Turning now to our guidance for 2020 for full year as well as the first quarter, we expect full year revenue growth to remain robust, but notably with Polaris <unk> and definitive we will make strategic investments across the organization to support currently commercialized products.
<unk> stabilization efficiencies from our new ERP system, which went live at the beginning of this year as well as advancing several important clinical pipeline efforts, which include clarify lifecycle management and advancing MK 60 to 40 among other projects, we forecast net clarify revenue to grow mid teens due predominantly to volume growth.
Robert J. Marshall: The resulting net, reported net income for the fourth quarter was $103.4 million and $122.7 million on an adjusted basis, an increase of 27% over the prior year period. Gap fully diluted earnings per share for the fourth quarter were $1.47 and $1.75 on an adjusted basis, an increase from the prior year of 28%. On a full-year basis, GAAP fully diluted earnings per share were $4.65 and $6.23 on an adjusted basis, an increase of 47.7% over the prior year. Now turning to cash flow, fourth quarter operating cash flow totaled $112.3 million as compared to $105.4 million in Q4 2022. Capital expenditures totaled $12.1 million, $7.3 million higher than the prior year quarter.
Together with a slight annual net price benefit with sequential trends that should follow those noted throughout 2023.
Clarify supported by high single digit growth from the affinity and relative steady contribution from the balance of the portfolio taken.
Taken together, we estimate full year revenue to be in a range of 1412, $144 5 billion, an increase of approximately 11% to 14% over 2023.
When excluding <unk> from the 2023 result.
For modeling purposes gross profit margins should be in line with 2023, even after considering the headwind created by the Relistor royalty divestiture mid last year and as Paul mentioned inclusive of our mitigation efforts to address the impacts of clarify its potential traditional pass through exploration at the end of 2024 throughout.
Robert J. Marshall: Free cash flow, which we define as operating cash flow less capital expenditures, was $100.2 million, effectively flat with the prior year period, and $258.7 million for the full year, which includes the $99.6 million CVR payment to former Progenic shareholders last year. Taken together, cash and cash equivalents, net of restricted cash, now stand at $713.7 million. We have access to our $350 million undrawn bank revolver and are very comfortable with our strong liquidity. Turning now to our guidance for 2024 full-year as well as the first quarter, we expect full-year revenue growth to remain robust, led notably by Polarify Independence. We will make strategic investments across the organization to support currently commercialized products, drive stabilization efficiencies from our new ERP system, which went live at the beginning of this year, as well as advance several important clinical pipeline efforts, which include Polarified Lifecycle Management and advancing MK6240, among other projects.
Throughout 2024, we will continue to take steps to ensure we remain the market leader in 'twenty five and beyond by building long term strategic partnerships with select customers are operating expense forecast is expected to be in the range of 24% to 25% of revenue due to the investments noted earlier.
Other interest income and expense should be reflective of our debt capital structure as well as approximately $36 million of interest income based on current and projected cash balances and forward interest rate curves. The effective tax rate assumed is 26, 6% free.
Free cash flows are expected to be nearly double the 2023 results, providing significant strength to our balance sheet and ability to execute on our growth strategy and targeted acquisitions.
Lastly, fully diluted shares to be between 71 to 72 million shares.
Therefore for the full year, we expect fully diluted adjusted earnings per share to be in a range of $6 50.
To $6 70.
For the first quarter net revenue should be in a range of $347 million to $355 million fully diluted adjusted earnings per share should be in a range of $1 50 to $1 54.
And again for year over year comparison purposes. The prior year results had approximately $6 million of relistor royalties or <unk> of contribution in that quarter and should be removed.
Robert J. Marshall: We forecast net Polarified Revenue to grow in the mid-teens due predominantly to volume growth together with a slight annual net price benefit, with sequential trends that should follow those noted throughout 2023. Polarify is supported by high single-digit growth from DFINITY and a relatively steady contribution from the balance of the portfolio. Taken together, we estimate full-year revenue to be in a range of $1.41 to $1.445 billion, an increase of approximately 11 to 14 percent over 2023 when excluding Relastor from the 2023 results. For modeling purposes, gross profit margins should be in line with 2023, even after considering the headwind created by the Relestor royalty divestiture mid last year and, as Paul mentioned, inclusive of our mitigation efforts to address the impacts of Flarifite's potential traditional pass-through expiration at the end of 2024.
Lastly for modeling purposes, depreciation and amortization for the full year 2024 should be approximately 12 and $36 million, respectively generally spread evenly throughout the year.
Before turning the call back over to Marianne I'd like to thank her for the last five plus years of partnership and friendship.
It's truly been an honor and pleasure to have worked alongside you and I Dare say on behalf of all employees. Thank you and we wish you the best.
Thank you, Bob and I feel the same that our partnership.
2023 was another stellar year for Landsea, delivering strong commercial and operational performance.
As the leading radiopharmaceutical focused company, we will continue to leverage our deep expertise and our significant capital resources to advance and expand our pipeline.
I would like to take a moment to express my gratitude for the incredible journey iPad Atlantean.
The organization has gone through significant change during my nine years as CEO and we are now in an outstanding position to continue to lead the way in bringing novel radiopharmaceutical innovations to patients.
Robert J. Marshall: Throughout 2024, we will continue to take steps to ensure we remain the market leader in 2025 and beyond by building long-term strategic partnerships with select companies. Our operating expense forecast is expected to be in a range of 24 to 25% of revenue due to the investment noted earlier. Other interest income and expense should be reflective of our debt capital structure as well as approximately $36 million of interest income based on current and projected cash balances and forward interest rate curves. The effective tax rate assumed is 26.6%.
This marks my last earnings call and I'm thrilled to pass the baton to Brian.
I am confident Brian will lead <unk> to new Heights, and I'm looking forward to remaining involved as the future of Llambias unfolds.
My role as chair of the board of Directors becomes official on March one.
Same day that Brian assumes the role of CEO.
To everyone across the landscape organization I want to say thank you for all of your hard work and your dedication.
Thanks Marianne.
I am truly honored and excited to take on the role of CEO for Lantus.
Having served on the board I've witnessed the unwavering dedication to our purpose values and patients we serve.
Robert J. Marshall: Free cash flows are expected to be nearly double the 2023 result, providing significant strength to our balance sheet and ability to execute on our growth strategy and targeted acquisitions. Lastly, fully diluted shares should be between 71 and 72 million. Therefore, for the full year, we expect fully diluted, adjusted earnings per share to be in a range of $6.50 to $6.70. For the first quarter, net revenue should be in a range of $347 million to $355 million. Fully diluted, adjusted earnings per share should be in a range of $1.50 to $1.54.
This transition is about continuity building on the strong foundation established by Mary Anne.
Who has led us with great wisdom envision I look forward to leading this amazing team and continue our commitment to excellence innovation at a shared purpose for the patient.
For the benefit of our patients.
With that we're now ready to take questions. Operator. Please go ahead.
Thank you.
To ask a question. Please press star one on your telephone and wait for your name to be announced before proceeding with your question as well we ask that you ask one question per person.
To withdraw your question. Please press star one again, one moment, while we compile the Q&A roster.
Our first question today will be coming from Anthony Petrone.
Robert J. Marshall: And again, for year-over-year comparison purposes, the prior year result had approximately $6 million of rela store royalties or $0.06 of contribution in that quarter and should be removed. Lastly, for modeling purposes, depreciation and amortization for the full year 2024 should be approximately $12 and $36 million, respectively, generally spread evenly throughout the year. Before turning the call back over to Marianne, I'd like to thank her for the last five plus years of partnership and friendship. It's truly been an honor and pleasure to have worked alongside you, and I dare say, on behalf of all employees, thank you. We wish you the best. Thank you, Bob, and I feel the same about our partnership. 2023 was another stellar year for Lantheus, delivering strong commercial and operational performance. As the leading radiopharmaceutical-focused company, we will continue to leverage our deep expertise and our significant capital resources to advance and expand our pipeline. I would like to take a moment to express my gratitude for the incredible journey I have had on Lantheus.
<unk>.
Mitzel group your line is open.
Okay.
You and.
I want to say congratulations again to Marianne It was a great journey enjoyed covering the company as from IPO through execution here. So congratulations on a great run and good luck on the next chapter and also congratulations to Brian I'll start with Polaris Sai.
And just the guidance the guidance for the.
The full year and <unk> is actually ahead of our model. So maybe just a little bit to scrub out the Polaris side drivers in there a little bit of help on what we should be thinking about in terms of volume growth for Polaris side that would be the first question.
Are we baking anything for EU.
Launch and then lastly prices is there any price baked in to the Polaris Sai equation for 2024.
And again congratulations to everybody.
Thank you Anthony Thanks.
Thanks, Anthony really appreciate the question. So as we mentioned in our formal guidance, we expect Polaris to grow mid teens. This year predominantly driven by volume with a slight annual net price benefit.
Mary Anne Heino: The organization has gone through significant change during my nine years as CEO, and we are now in an outstanding position to continue to lead the way in bringing novel radiopharmaceutical innovations to patients. This marks my last earnings call, and I'm thrilled to pass the baton to Brian. I'm confident Brian will lead Lantheus to new heights, and I'm looking forward to remaining involved as the future of Lantheus unfolds.
I'll speak to volume and price and then next on the EU piece with Polaris <unk> being the clear market leader, we do believe that it continues to offer value to the prostate cancer community and that our pricing is comparable to most other PMA pet imaging agents on the market.
It did take a 6% WAC price increase at the beginning of the year I would note. We took price increase beginning of last year and the year before that as well.
Brian Markeson: My role as Chair of the Board of Directors becomes official on March 1st, the same day that Brian assumes the role of CEO. To everyone across the Lantheus organization, I want to say thank you for all of your hard work and your dedication. Thanks, Barry.
This is a large and growing market and we believe there is ample room for multiple players and for sustained volume and revenue growth going forward at the overall guidance is predominantly focused on the U S and includes de Minimis EU components at this point.
Brian Markeson: I'm truly honored and excited to take on the role of CEO for Lantheus. Having served on the board, I've witnessed the unwavering dedication to our purpose and the Values and Patients We Serve. This transition is about continuity, building on the strong foundation established by Mary Ann, who has led us with great wisdom and vision. I look forward to leading this amazing team and continuing our commitment to excellence, innovation, and a shared purpose for the patient, for the benefit of our patients. With that, we're now ready to take questions. Operator, please go ahead. Thank you. To ask a question, please press star one one on your telephone and wait for your name to be announced before proceeding with your question.
Now this tack on and just note that we're sitting here at the end of February and.
Obviously, when you're sitting here at this point in the quarter. It gives you some fairly decent insights into how the market is shaping up at this part of the year.
No. That's helpful. And then maybe one quick follow up just on timing for or rather expectations and the scenario analysis around reimbursement. This dual efforts out there for clarify maybe your latest thoughts on how CMS can settle out here.
As we are.
<unk> exploration of the transition pass through status and then any update on the find act and I'll hop back in queue. Thanks again.
Operator: As well, we ask that you ask one question per person. To withdraw your question, please press star 11 again. One moment while we compile the Q&A rock. Our first question today will be from Anthony Petrone of Mitsu Group. Your line is open. Thank you, and I want to say congratulations again to Mary Ann. It was a great journey.
Thanks, Anthony so transitional pass through status.
As we've noted before impacts about 20% of prostate cancer patients and will impact the <unk> pet class as a whole with three of the four available agent.
<unk> agents, losing transitional pass through status in the first nine months of 2025 out.
Anthony Petrone: I enjoyed covering the company from IPO through execution here, so congratulations on a great run. And good luck on the next chapter, and also congratulations to Brian. I'll start with Polarify and just the guidance.
To ensure we remain the number one utilized PMA pet imaging agent, we have as I noted on my prepared remarks continue to enter into long term strategic partnerships with select customers to ensure they have access to and preferably choose Polaris high as their PMA path agent of choice and we are fiercely committed to ensuring clarify remains available.
Anthony Petrone: The guidance for the full year in 1Q is actually ahead of our model. So maybe just a little bit to scrub out the Polarify drivers in there, a little bit of help on what we should be thinking about in terms of volume growth for Polarify, that would be the first question. Are we baking anything for the EU?
Alible for patients continues to grow and remains the clear market leader.
We do continue to work with CMS and would expect proposed fiscal year 2025 rules to come out in July, but we do continue to have ongoing conversations with them to make them aware of the potential impact to patient access over time, if the current CPT construct remains and then naturally we continue.
Anthony Petrone: Uh... launch uh... and then lastly, prices. Is there any price baked in to the polarify equation for twenty twenty four? Thanks, Anthony. Really appreciate the question. So, as we mentioned in our formal guidance, we expect Polarify to grow mid-teens this year, predominantly driven by volume with a slight annual net price benefit.
To support legislation in both the house and the Senate of what's defined App has been introduced.
Brian Markeson: I'll speak to volume and price, and then next on the EU piece. With Polarify being the clear market leader, we do believe that it continues to offer value to the prostate cancer community and that our pricing is comparable to most other PSMA PET imaging agents. We did take a 6% WAC price increase at the beginning of the year.
And to ensure that Congress and the Senate understand the benefits for doing so and so that's that's the nature of where we are but naturally we're fiercely focused on defending growing and continue insurer Polaris <unk> remains the market leader going forward.
Thank you.
Brian Markeson: I would note we took price increases at the beginning of last year and the year before that as well. This is a large and growing market, and we believe there is ample room for multiple players and for sustained volume and revenue growth going forward. The overall guidance is predominantly focused on the U.S. and includes de minimis EU components.
Our next question.
Our next question will come from.
<unk>.
Of Leerink partners. Your line is open.
Great. Good morning, everyone. So I wanted to dig in a little bit more with clarify could you talk a bit about the evolving dynamic of clarify use between larger academic institutions and freestanding imaging centers and how might that evolves in the next couple of years.
Brian Markeson: And Anthony, I'll just add on and just note that, you know, we're sitting here at the end of February and, obviously, when you're sitting here at this point in the quarter, it gives you some fairly decent insights into how the market is shaping up this part of the year. That's helpful, and let me give you one quick follow-up on timing for, or rather expectations, and the scenario analysis around reimbursement. There are dual efforts out there for Polarify, you know, maybe, you know, your latest thoughts on how CMS can settle out here as we approach the expiration of the transition pass-through status and then any update on the FIND Act, and I'll hop back in queue. Thanks again.
Expect caster exploration for clarify.
It's a great question around us so overall, we view PSA Pat and indeed, the bulk of pet imaging to be split roughly 60% hospital, 35% freestanding imaging center and approximately 5% government overtime. The freestanding imaging centers continued to grow.
They expand hospitals in some cases have been outsourcing them and overall, we would expect that trend to continue.
As care moves outside the hospital system and into more of those freestanding centers.
<unk> cameras are equally distributed relatively proportionately across those and so naturally transitional pass through status only impacts about 20% of patients or roughly one third of the hospital business recognizing that's within the hospital a portion of their business would be commercial payers, which is.
Brian Markeson: Thanks, Anthony. Transitional pass-through status, as we've noted before, impacts about 20% of prostate cancer patients and will impact the PSMA PET class as a whole, with three of the four available agents losing transitional pass-through status in the first nine months of 2025. To ensure we remain the number one utilized PSMA PET imaging agent, we have, as I noted in my prepared remarks, continue to enter into long-term strategic partnerships with select customers to ensure they have access to and preferably choose Polarify as their PSMA PET agent of choice. And we are fiercely committed to ensuring Polarify remains available for patients, continues to grow, and remains the clear market. We do continue to work with CMS and would expect proposed fiscal year 2025 rules to come out in July, but we do continue to have ongoing conversations with them to make them aware of the potential impact to patient access over time if the current TPT construct remains. And then, naturally, we continue to support legislation in both the House and the Senate, of which the FIND Act has been introduced, and to ensure that Congress and the Senate understand the benefits.
On impacted by pass through as well as Medicare advantage, which has an impacted and so you're really looking at an overall majority of their business and so we would expect those trends to continue to evolve with freestanding imaging centers continued to be more important but I don't think we expect dramatic shifts in the overall business going forward.
Thank you the next question.
One moment.
Our next question will be coming from Richard <unk> of <unk> Securities. Your line is open.
Hi, Thanks for taking the questions.
And congrats Maryann on your next chapter and to Brian Echoing.
Anthonys comments so.
I wanted to start off.
Just on some of the mitigating strategies that you mentioned, Paul Theres anymore for <unk>.
Transitional pass through is there any more color you can provide on kind of what those are and just.
In answering that question you can address two things one I think I heard you say you expect.
Clarify that continue growing.
So is that a commitment to.
Paul Blanchfield: So that's the nature of where we are. But naturally, we're fiercely focused on defending, growing, and continuing to ensure Polarify remains the market. Thank you. Our next question. Our next question will be coming from... Rwana Rueg, of Lyric Partners. Your line is open. Great morning, everyone.
Growth likely beyond transitional pass through for Polaris, Sai and I would imagine there'd be some pricing strategies in there as well as some impact of pricing. So if you could just comment on what if anything that would impact as you move through the year as some of those mitigating strategies get going in 'twenty four.
Paul Blanchfield: So I wanted to dig in a little bit more with CLARIFY. Could you talk a bit about the evolving dynamic of CLARIFY use between larger academic institutions and freestanding imaging centers, and how might that evolve in the next couple years if you expect continued year-end exploration for CLARIFY? It's a great question, Rana. Overall, we view PSMA PET, and indeed the bulk of PET imaging, to be split roughly 60% hospital, 35% freestanding imaging center, and approximately 5% government.
And then if you could elaborate on what those mitigating strategies actually mean, thank you.
So thanks for the question rich.
Noted in the prepared remarks, we do continue to enter into long term strategic partnerships with select customers to ensure they have access to and preferably choose a polaris.
We are fiercely committed to ensuring clarify is available for patients continues to grow and remains the market leader, but given the competitive nature of the market I don't want to elaborate further on the specifics of those customer partnerships and what that means.
Paul Blanchfield: Over time, freestanding imaging centers continue to grow. They also expand. Hospitals, in some cases, have been outsourcing them, and overall, we would expect that trend to continue as care moves outside the hospital system and into more of those freestanding centers. PET-CT cameras are equally distributed relatively proportionally across those, and so, naturally, transitional pass-through status only impacts about 20 percent of patients, or roughly one-third of the hospital business. Recognizing that within the hospital, a portion of their business would be commercial payers, which are unimpacted by pass-through, as well as Medicare Advantage, which is unimpacted.
That would be inappropriate at this point, but take it that we are fiercely focused on this we talked about it on a daily basis and.
And we are focused on ensuring that <unk> continues to grow remains the market leader and it's available for patients as we think towards long term growth as I mentioned, the overall PMMA pet market will continue to expand with the potential growing this year from approximately $2 billion to $3 billion plus by 2029, and so there is still ample opportunity.
To continue to grow we have also noted that both on a quarterly and annual basis that growth is not necessarily linear.
As new indications become available and as the market expands we are focused on the long term and continuing to grow.
Thank you one moment for the next question.
The next question is coming from Zhan Zhong of B Riley Your line is open.
Paul Blanchfield: And so you're really looking at an overall minority of their business. And so we would expect those trends to continue to evolve, with freestanding imaging centers continuing to be more important, but I don't think we expect dramatic shifts in the overall business. Thank you. The next question. One moment.
Good morning, glad to see the 20-F for guidance.
Can you guys talk about the current plan of 14, which was 002 and a further clinical development in consideration and is there any trigger points.
Thank you.
Okay.
Yeah. Thanks for the question this is Brian.
We are closely watching.
Richard Neuwirter: Our next question will be coming from Richard Neuwirter of Truist Securities. Your line is open. Hi, thanks for taking the questions, and congrats, Mary Ann, on your next chapter, and to Brian, echoing Anthony's comments. So I wanted to start off just on some of the mitigating strategies that you mentioned, Paul. If there's any more for the transitional path through, is there any more color you can provide on kind of what those
Oh, two in the splash data and we continue to look at various slices of the information that's coming across.
And we remain encouraged quite frankly third quarter this year.
We're going to take a formal look pre specified at the data for <unk> and then we will.
We'll see what that tells us, but we think we're heading in the right direction.
Thank you one moment for the next question.
Yeah.
The next question is coming from Matt Taylor of Jefferies. Your line is open.
Hi, Thanks for taking the question.
Richard Neuwirter: And just in answering that question, you can address two things. One, I think I heard you say you expect Polarify to continue growing. So is that a commitment to growth? Probably beyond transitional pass-through for Polarify.
So I wanted to ask a follow up question on.
Clarify and I was hoping that you could take us into the most updated competitive dynamics. There I guess what are you seeing from the traditional gallium competitors color that you can give us on.
You've seen blue Earth acting in the market and the first part of this year.
Okay.
Richard Neuwirter: And I would imagine there'd be some pricing strategies in there as well as some impact of pricing. So if you could just comment on what, if anything, that would impact as you move through the year as some of those mitigating strategies get going in 24. And then you could elaborate on what those mitigating strategies actually mean.
Sure, Matt So clarify obviously as the clear market leader in overall, having been used in more than 300000 scans since launch.
The leader, we do disproportionately benefit from competition as more <unk> imaging agents come into the market they raise awareness and naturally clarify benefits from that rising tide competitively.
Paul Blanchfield: Thanks. So, thanks for the question, Rich. You know, as we noted in the prepared remarks, we do continue to enter into long-term strategic partnerships with select customers to ensure they have access to and, preferably, choose Polarify. We are fiercely committed to ensuring Polarify is available for patients, continues to grow, and remains the market leader, but given the competitive nature of the market, I don't want to elaborate further on the specifics of those customer partnerships and what that means. That would be inappropriate at this point, but you can take it that we are fiercely focused on this.
Competitively are estimates for market share had been relatively consistent over the past two quarters with clarify share on the mid to high 60% range I would note. That's an estimate is only two of the four now five.
Players report a product specific revenue importantly, I would note that our market revenue leadership continues to expand and indeed solidified both annually, where we grew from the fourth quarter of <unk> 23 versus the fourth quarter of 2000 to $86 million year over year as well as sequentially where we.
Paul Blanchfield: We talk about it on a daily basis, and we are focused on ensuring that Polarify continues to grow, remains the market leader, and is available for patients. As we think about long-term growth, as I mentioned, the overall PSMA pet market will continue to expand, with the potential growing this year from approximately $2 billion to $3 billion-plus by 2029, and so there is still ample opportunity for Polarify to continue to grow. We have also noted that, both on a quarterly and annual basis, growth is not necessarily linear.
<unk> from <unk> to <unk> by $14 million with that revenue dollar growth outpacing that of our competition and therefore, the impact that we've seen both in the fourth quarter and is factored into our guidance is minimal impact from recently approved <unk> agents.
Overall, we believe Theres a lot of growth left in the <unk> pet market as evidenced by the Cam of $2 billion growing to potentially a $3 billion Tam and we're focused as I've mentioned on ensuring clarify.
<unk> accessible to patients continues to grow and remains the clear market leader.
Paul Blanchfield: As new indications become available and as the market expands, we are focused on the long-term and continuing to grow. Thank you. One moment for the next question. The next question is coming from Zonzi of B Riley. Your line is open. Good morning.
Thank you one moment for the next question.
Next question will be coming from Justin walls of Jones trading your line is open.
Alright, thanks for taking the question.
There's a lot of excitement and interest around PD lone SAP in tow from a clinical perspective, but I was wondering if you could comment on thoughts about the relative commercial potential of the various imaging biomarkers.
Brian Markeson: Glad to see the 2024 guidance. Can you guys talk about the current plan for PNT2002, any further clinical development in consideration, and are there any trigger points for those developments? Thank you. Yeah, thanks for the question. This is Brian.
So I'll take that and I'll I'll focus on <unk>.
60 to 40, and what we see there as you heard in my remarks were really excited about the path. We see forward for potential commercial application with that product currently is being used in clinical trials, which with radio traces you were approved and allowed to do that and as I said it's avail.
Brian Markeson: You know, we're, you know, closely watching 2002 and the SPLASH data, and we continue to look at various slices of the information that's coming across. And we remain encouraged, quite frankly. Third quarter this year, we're going to take a formal look, pre-specified at the data for 2002.
Available and being used in over 90 clinical trials, but when you start looking at the commercial opportunity.
Zero kind of bifurcate my remarks between commercial opportunity from a revenue perspective, but then really from a value perspective.
Purposely said in my remarks that we see a corollary between what PSA imaging was able to bring from a relative value perspective to prostate cancer diagnosis and treatment selection, we see that same potential in Alzheimer's disease, which would represent.
Brian Markeson: And then we'll, we'll see what that tells us, but we think we're heading in the right direction. Thank you. One moment for the next question. The next question is coming from Matt Tyler of Jaffray's. Hi, thanks for taking the question. So I wanted to ask a follow-up question on Polarify, and I was just hoping that you could take us into the most recent version.
Really a big step forward for the physicians, who are trying to accurately diagnosed and then select treatment options for those patients and so that's what really excites us about now we have not yet announced.
Paul Blanchfield: Competitive dynamics there, I guess, what are you seeing from the traditional gallium competitors and the color that you can give us on how you've seen Blue Earth acting in the market in the first part of this year? Sure, Matt.
Commercial regulatory strategy, but it is something that we are actively looking at ingalls.
<unk> also engaged of course with the FDA on and so you'll hear us well not me.
Paul Blanchfield: So Polarify, obviously, is the clear market leader overall, having been used in more than 300,000 scans since launch. As the leader, we do disproportionately benefit from competition. As more PSMA imaging agents come into the market, they raise awareness, and naturally, Polarify benefits from that rising. Competitively, our estimates for market share have been relatively consistent over the past two quarters, with Polarify share in the mid to high 60% range. I would note that's an estimate as only two of the four, now five, players report product-specific revenue. Importantly, I would note that our market revenue leadership continues to expand and indeed solidify, both annually, where we grew from the fourth quarter of 23 versus the fourth quarter of 22, $86 million year over year, as well as sequentially, where we grew from 3Q to 4Q by $14 million, with that revenue dollar growth outpacing that of our competition. And therefore, the impact that we've seen, both in the fourth quarter and as it's factored into our guidance, is minimal impact from recently approved FAQs.
But you'll hear this team talking more and more about that into the future and maybe I'll just expand Marianne just.
On the specific market opportunities, we did share earlier this year that we view the addressable market for <unk> 640, specifically as alzheimer treatments come to market and the ability to be used for both patient staging and selection of approximately $1 $5 billion by the end of the decade, and so clearly another large opportunity.
<unk> with MK $6 40 being used in over 90 clinical trials, certainly has an opportunity to be a partner at those therapeutics come to market for the FAP agent. We are equally excited naturally it's a little bit earlier in development, we have not put a market potential on that yet, but I would note that we think about pan cancer pet imaging.
<unk> FDG, which has been around for over 30 years does north of 2 million scans per year. So if you think about the market potential.
Two large opportunity.
Thank you one moment for the next question.
Okay.
Okay.
Our next question is coming from Andy Shay of William Blair. Your line is open.
Great. Thanks for taking my question.
Paul Blanchfield: Overall, we believe there's a lot of growth left in the PSMA pet market, as evidenced by the TAM of $2 billion, growing to potentially a $3 billion TAM. And we're focused, as I've mentioned, on ensuring PolariFy remains accessible to patients, continues to grow, and remains, Thank you. One moment for the next question. The next question will be coming from Justin Walsh of Jones Trading. Your line is open.
I wanted to dig in more on the prospective deal curious if you can talk about the strategic positioning you envision for the various assets that you've mentioned on the call.
Specifically maybe.
Where do you think it will be physicians would it be slotted in the post <unk>.
Justin Walsh: Hi, thanks for taking the question. I think there's a lot of excitement and interest around PD-L1 FAP and TAU from a clinical perspective, but I was wondering if you could comment on your thoughts about the relative commercial potential of the various imaging technologies. So, I'll take that, and I'll focus on MK6240 and what we see there. As you heard in my remarks, we're really excited about the path we see forward for potential commercial application with that product. Currently, it's being used in clinical trials, which with radio tracers, you are approved and allowed to do.
<unk> setting.
Before given that there is a pretty material difference and pathways.
And hopefully the supply chain will perspective be providing the generators on site clinical.
Clinical trial site and what's the kind of long term capacity that we should be thinking about it. Thank you so much.
So.
Take that question for the group and anyone else can add in I think first to your question about where we are across the spectrum of prostate cancer can be assets be applied youre exactly right two to ask can it be pre or post chemo, which would then kind of described in relation to where the lutetium based products are being used.
Brian Markeson: And as I said, it's available and being used in over 90 clinical trials. But when you start looking at the commercial opportunity, and here I'll kind of bifurcate my remarks between the commercial opportunity from a revenue perspective, but then really from a value perspective. And I purposely said in my remarks that we see a corollary between what PSMA imaging was able to bring from a relative value perspective to prostate cancer diagnosis and treatment selection.
And the answer is yes, and yes that is something I think we're all learning is when you look at splash as we look at TSMC for as we look at the original vision trial. It really does help us I would say evaluate where these products are best placed and as I believe Paul might have added in his comments, we see these products moving earlier in line of therapy.
Brian Markeson: We see that same potential in Alzheimer's disease, which would represent, you know, really a big step forward for physicians who are trying to accurately diagnose and then select treatment options for those patients. And so, that's what really excites us. Now, we have not yet announced our commercial regulatory strategy, but it is something that we are actively looking at and also engaged, of course, with the FDA on. And so, you'll hear us, well, not me, but you'll hear this team, talking more and more about that in the future.
Because of the benefit they can receive especially with respect to the side effect profile. The total kind of I would say.
Safety versus benefit profile of these products versus chemo agent. So that is something that again, we have not yet been public about as something Larry.
Paul Blanchfield: And maybe I'll just expand, Mary Ann, just on the specific market opportunity. We did share earlier this year that we view the addressable market for MK6240, specifically as Alzheimer treatments come to market, and the ability to be used for both patient staging and selection, of approximately $1.5 billion by the end of the decade. And so, clearly, another large opportunity with MK6240 being used in over 90 clinical trials. And so, it certainly has an opportunity to be a partner as those therapeutics come to market. For the FAP agent, we are equally excited, although naturally, it's a little bit earlier in development. We have not put a market potential on that yet, but I would note that when you think about pan-cancer PET imaging agents, FDG, which has been around for over 30 years, does north of 2 million scans per year.
Paul Blanchfield: So, if you think about the market potential, it's a big opportunity. Thank you. One moment for the next question. Our next question is coming from Andy Shea of William Blair. Your line is open.
We think it has the potential.
<unk> to be best in class and that's one that we're very close to as well. So we liked their platform. We liked the targets they have and we especially liked early program.
Andy Shea: Thanks for taking my question. I wanted to dig in more on the prospective deal. Curious if you can talk about the strategic positioning you envision for the various asset that you mentioned on the call. Specifically, maybe where do you think it will be positioned? Would it be spotted in the post-lutetian setting?
Thank you one moment to the next question.
Our next question comes from Laurie.
Okay.
Security is your line is open.
Great. Thank you and.
Congratulations to you as well and a six year run for a procedure you off.
Thanks, Larry.
Brian Markeson: or before, given that there's a pretty material difference in path length. And also, the supply chain: will Perspective be providing the generators on-site, at the clinical trial site? And what's the kind of long-term capacity that we should be thinking about? Thank you so much. So, I'll take that question for the group, and then anyone else can add in. I think first, where across the kind of spectrum of prostate cancer can these assets be applied? You're exactly right to ask whether it can be pre- or post-chemo, which would then kind of describe in relation to where the lutetium-based products are being used.
Brian Welcome we look forward to work with you.
It's just a question for both of my questions have been answered that question for you. It looks like if I do the math on the guidance or at the mid point.
Your revenue guidance.
<unk> it looks like margins up modestly looks just 300 beds hung up on the line.
Outright.
Where is that going to shake out is it a little bit more on that.
Uhm gross more than sorry, or did you get a little leverage and then parts of the question is are you building in some increased expenses or material increases for four.
22002, this year or is that more of a waiting thanks.
Alright, Thanks, Larry that's a great. That's a great set of questions Uhm Martin should be relatively flat, maybe slightly improved but again I think if you peel out the impact of the relistor royalty out of the prior year.
Brian Markeson: And the answer is yes and yes. That is something I think we're all learning as we look at SPLASH, as we look at TSMA-4, as we look at the original VISION trial. It really does help us, I would say, evaluate where these products are best placed. And as I believe Paul might have added in his comments, we see these products moving earlier in the line of therapy because of the benefit they can receive, especially with respect to the side effect profile, the total kind of, I would say, safety versus benefit profile of these products versus chemo agents.
That's about 80 basis point headwind so to remain flat is actually an increase in you're right that is coming from.
Product mix in terms of clarify and affinity.
As well as you know some of the other cost containment factors being able to manufacture diffin any on campus that that's contributing and helping and yes you are seeing.
An increase in in overall spend but I can tell you that we don't have.
Brian Markeson: So, that is something that, again, we have not yet been public about. It's something we're, you know, working with perspective on to decide what the best applications for these products are as we bring them in their first applications to market. With respect to the supply chain, it's a really good question. And the lead-212-based isotopes right now have more than one option, I'll say, as to how they come into the channel. You can either, because of the half-life, you have the option here to either do kind of central manufacturing and distribution or regional distribution or a combination of both, depending on what market you're in.
Spend for 2002 embedded in our expenses, mainly that's because we want to make sure that we're faced gaming. So is Brian indicated earlier, an impulse remarks.
<unk>, we're waiting for the data to mature before we put further investment and.
When that data does read out we will make you know.
Or not make investment as appropriate and we will communicate that to the street I think another driver you know is the byproduct of having a lot of cash on the balance sheet and there is significant when I look through the consensus models.
I did note that it sort of under under.
I appreciate it the current level of interest rates and the forward curve that we see so with this level of cash you know it does generate that level of interest income that I noted in my scripted remarks around $36 million.
Brian Markeson: And there, again, we have not been specific yet. And I would actually refer you to their website for perspective. They have got some information and some material on their website that speaks to the efforts they've already undertaken in the supply chain. It is, as you were noting, something that needs to reach commercial scale before we get to market. But we're confident that that can be achieved. You know, I think I'll just add to that a little bit. Their lead program in neuroendocrine tumors has us very interested, and we think it has the potential to be best in class. And that's one that we're very close to as well. So we like their platform.
Taxeme does a good time it does a good job so as you kind of work down through the piano.
That's what's creating our opportunity to continue to expand.
And drive profitability for the company, while taking the opportunity to invest appropriately across many aspects of the organization whether that be.
All the things that Paul talked about in terms of clarify protection and mitigation strategies as well as market access market research. This development activities, which you know can be consuming and inexpensive uhm, but also.
Things that we've done with our ERP that the company did a fantastic job putting that in place.
Brian Markeson: We like the targets they have, and we especially like their lead program. Thank you. One moment for the next question. Our next question comes from Larry Solow of CJS Securities. Your line is open. Great. Thank you. And Mary Heino, congratulations to you as well.
But it does come with a cost but at the same time those costs will ultimately drive workflow efficiencies that I think will continue to provide opportunities to invest in other aspects of our business much like our R&D pipeline.
Larry S. Solow: It's been a good six-year run for CJS and myself. I know. Thanks, Larry. Absolutely. Brian, welcome.
Thank you one moment for the next question.
Our next question is coming from Kent Bolivar of Brookline capital markets. Your line is open.
Larry S. Solow: Question for you looks like your revenue guidance is up mostly 100 bits on the operating line. Is that right, and where is that going to shake out? Is it a little bit more on the Gross margins, do you get a little leverage? And then part two of that question: are you building in some increased expenses or material increases for PNC 2002 this year? Or is that more of a, All right, thanks, Larry. That's a great set of questions.
Thank you and good morning, My question relates to.
P. A T 203, and the market potential data could you just speak quickly about.
What drives the increases in the Tam between 2024 and 2029 <unk>.
Because point.
You had indicated both age traditional generic strategy and then ultimately in India a strategy for <unk>.
Robert J. Marshall: Margin should be relatively flat, maybe slightly improved. But again, I think if you peel out the impact of, you know, the retail store royalty out of the prior year, that's about an 80 basis point headwind. So to remain flat is actually an increase.
Different indications and the gift that space. So if you are the next space.
Robert J. Marshall: And you're right, that is coming from, you know, product mix in terms of Polarify and DFINITY, as well as, you know, some of the other cost containment factors, you know, being able to manufacture DFINITY on campus, that's contributing and helping. And yes, you are seeing an increase in overall spend. But I can tell you that we don't have spending for 2002 embedded in our expenses.
Could you just speak to that in a little more detail.
Yeah, I'm happy to take that so as we note in our prepared remarks, we did submit and and for piano T 2003, which has been accepted by the FDA and based on available public information. We believe we are the first applicant.
Uhm the market. We estimate currently has an addressable market without a $1 billion in 2024, and that's actually on one of the prepared slides and.
And that's about 4000, plus patients with a real focused on metastatic second line within <unk> as we've seen from recent trial results.
Robert J. Marshall: And mainly that's because we want to make sure that we're phase gating. So as Brian indicated earlier in Paul's remarks, you know, we're waiting for the data to mature before we make further investment. And when that data does read out, we will make, you know, or not make an investment as appropriate, and we will communicate that to the street. I think another driver, you know, is, you know, the byproduct of having a lot of cash on the balance sheet. And there is significant, and when I look through the consensus models, I did note that it's sort of under, under, appreciate it, you know, the current level of interest rates and the forward curves that we see. So with this level of cash,
N potential expanded use of the somatostatin receptor targeted RL T. We believe there is an opportunity for the overall market to grow specifically in first line as well as into other nets as well as <unk> and so when we look at what that potential is from a <unk>.
<unk> it won't necessarily change the proposed labels. This is more likely updates to guidelines, which would expand the potential use of this asset class into those and that's really driving much of the expansion and then as you get out in five years, there's really just continued expansion of overall incidence and prevalence.
Robert J. Marshall: It does generate that level of interest income that I noted in my scripted remarks, around $36 million. You know, the tax team does a good job, so as you kind of work down through the P&L, that's what's creating our opportunity to continue to expand and drive profitability for the company, while taking the opportunity to invest appropriately across many aspects of the organization, whether that be, you know, all the things that Paul talked about in terms of clarified protection and mitigation strategies, as well as market access, market research, and business development activities. Which, you know, can be time-consuming and expensive, but also, things that we've done with our ERP, the company did a fantastic job putting that in place, but it does come with a cost, but at the same time, those costs will ultimately drive workflow efficiencies that I think will continue to provide opportunities to invest in other aspects of our business, much, you know, like our R&D pipeline. Thank you. One moment for the next question. Our next question is coming from Kent Dolliver of Brookline Capital Markets. Your line is open. Thank you, and good morning.
Natalie more men and women continue to be diagnosed and present with these and so overall, we view this as a large market opportunity out with multiple room for additional players and <unk> 2003, and we'll certainly be talking more about this opportunity at our go to market strategy.
As we get closer to 2026 and a potential option.
Thank you one moment for our next question.
Our next question will be coming from day, particularly.
The Security's your line is open.
Good morning, [laughter], you mentioned the ferocity of some of your long term partnership so I guess I just wanted to ask.
Can you sign these things can they be exclusive and can they be multi yearly can can you have contracts that go through 25 and 26.
I'm, just trying to get a sense of.
That that that word and then sort of what you can do with these customers to potentially maybe black some of them up.
I'm just gonna start by clarifying we said we were fiercely fiercely defend our business, but we would not describe our partnerships porosis.
They're very amiable and there are two way, but I'll <unk> I'll, let Paul speak more to what our strategy is there no I. Appreciate the question naturally I'm not gonna go into significant detail given the competitive nature of it but yes, we can enter into longterm contracts by that I mean multiyear.
Kent Dolliver: My question relates to PNT 2003 and the market potential data. Could you just speak quickly about, What drives the increases in the TAM between 2024 and 2029? Because Point indicated both a traditional generic strategy and then ultimately an NDA strategy for different indications in the GEP net space. So if you, or the net space.
Whiskey customers to insure that Pollero five remains their preferred choice of agents Uhm I'll wait till overtime to discuss more about what those specifically means but we have an incredibly experienced commercial team.
Paul Blanchfield: Could you just speak to that in a little more detail? Yeah, I'm happy to take that. So, as we note in our prepared remarks, we did submit an ANDA for PNT-2003, which has been accepted by the FDA. And based on available public information, we believe we are the first applicant. The market, we estimate, currently has an addressable market of about a billion dollars in 2024, and that's actually on one of the prepared slides, and that's about 4,000-plus patients with a real focus on metastatic second line within GFNATS. As we've seen from recent trial results in the potential expanded use of the somatostatin receptor-targeted RLT, we believe there is an opportunity for the overall market to grow specifically in first line, as well as into other NETs, as well as Pheo and Para.
Which includes market access national accounts, and overall sales team others, very well experienced in working with commercial customers that we know deeply and have built longterm relationships over the last number of years and the strategic partners shops helped codify that relationships and ensure that we remain solid partners together.
For years to come.
I'll just add also you Ah me directly as to whether these partnerships were exclusive and it is very atypical in the radiopharmaceutical space to ask for exclusivity just because of the supply chain is supply chain considerations for these products are strategy would be to routine clarifies role as the most chosen and market leading.
Choi 40th and they based imaging.
Thank you.
One moment for our next question.
Paul Blanchfield: And so when we look at what that potential is from a utilization perspective, it won't necessarily change the proposed labels. This is more likely to be updates to guidelines, which would expand the potential use of this asset class into those, and that's really driving much of the expansion. And then as you get out in five years, there's really just continued expansion of overall incidence and prevalence. Unfortunately, more men and women continue to be diagnosed and present with these conditions.
And our final question of the day will be from Richard <unk> two of Securities. Your line is open.
Hi, Thanks for taking the follow up I just had one additional one you know on transitional pass through one of your competitors has talked publicly about product lifecycle management.
Possibly even you know restarting the transitional past due clock you know for for.
Next generation type.
Diagnostic offering if.
If it can get approved food to the F. D. A I'm just curious if you have any views on on this kind of strategy is there anything you have in the pipeline.
Paul Blanchfield: And so, overall, we view this as a large market opportunity with room for additional players, including PNT2003, and we'll certainly be talking more about this opportunity and our go-to-market strategy as we get closer to 2026 and a potential expansion. Thank you. One moment for our next question. Our next question will be coming from David Kirkley of NAMP Securities. Your line is open. Good morning.
<unk> indication expansion I appreciate the mirror study and intermediate favorable indication expansion and that sounds promising but more specific to the product lifecycle management concept. Thank you.
No.
I understand the question rich appreciate it but we're not going to comment publicly on what our competitors and of other public companies as sad as you noted we are focused on lifecycle management clarify both of the mirror study as well as assessing its use and non-profit answer.
David Kirkley: You mentioned the ferocity of some of your long-term partnerships, so I guess I just wanted to ask, you know, can you sign these things? Can they be exclusive, and can they be multi-year? Like, can you have contracts that go through 25 and 26?
Because <unk> is expressed by other solid tumors four pass through our primary focus is really to work with customers to ensure that we remain the preferred agent of choice and then naturally to engage with CMS to support legislation as well as I should CMS to support regulation and then.
David Kirkley: I'm just trying to get a sense of... That word and then sort of what you can do with these customers to potentially maybe lock some of them up. I'm just going to start by clarifying that we said we were fiercely willing to fiercely defend our business, but we would not describe our partnerships as ferocious. In fact, they're very amiable, and they're two-way streets, but I'll let Paul speak more about what our strategy is there. No, I appreciate the question. Naturally, I'm not going to go into significant detail given the competitive nature of it, but yes, we can enter into long-term contracts. By that, I mean multi-year contracts with key customers to ensure that Polarify remains their preferred choice of agent. I'll wait until over time to discuss more about what those specifically mean, but we have an incredibly experienced commercial team, which includes market access, national accounts, and an overall sales team that is very well experienced in working with commercial customers that we know deeply and have built long-term relationships with over the last number of years.
Work with the find act specifically supporting legislation.
And so I'm not going to comment publicly on what competitors have stated about their their lifecycle management Uhm. We believe clarify is clear market leader. We believe the market is large and continues to grow and we are focused on ensuring it remains accessible to patients that clarified continues to grow and then it remains the clear market.
Thank you.
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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David Kirkley: These strategic partners help codify that relationship and ensure that we remain solid partners together for years to come. I'll also add that you made a reference to whether these partnerships were exclusive, and it is very atypical in the radiopharmaceutical space to ask for exclusivity just because of the supply chain and supply chain considerations for these products. Our strategy would be to retain Polarify's role as the most chosen and market-leading choice for PSMA-based imaging.
Paul Blanchfield: Thank you. One moment for our next question. And our final question of the day will be from Richard Kneewitter of Truist Securities. Your line is open. Hi, thanks for taking the follow-up. I just had one additional one.
Richard Kneewitter: You know, on Transitional Pass-Thru, one of your competitors has talked publicly about product lifecycle management, possibly even restarting the transitional pass-through clock for a next-generation diagnostic offering if it can get approved through the FDA. I'm just curious if you have any views on this kind of strategy. Is there anything you have in the pipeline beyond indication expansion? I appreciate the mirror study and intermediate favorable indication expansion, and that sounds promising, but more specific to the product life cycle management concept. Thank you. Yeah, no. I understand the question, Rich.
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Paul Blanchfield: I appreciate it. We're not going to comment publicly on what our competitors and other public companies have said. As you noted, we are focused on life cycle management, but clarify both the mirror study as well as assessing its use in non-prostate cancer because PSMA is expressed by other solid tumors for pass through. So, our primary focus is really to work with customers to ensure that we remain the preferred agent of choice and then naturally engage with CMS to support legislation as well as should CMS to support regulation and then work with the find act specifically supporting legislation. And so I'm not going to comment publicly on what competitors have stated about their life cycle management.
Paul Blanchfield: We believe Clarify is the clear market leader. We believe the market is large and continues to grow, and we are focused on ensuring. It remains accessible to patients that polarity continues to grow, and then it remains stable.
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[music].
Paul Blanchfield: Thank you. 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. www.larryweaver.com www.larryweaver.com, Copyright 2020 Mooji Media Ltd. All Rights Reserved. No part of this recording may be reproduced without Mooji Media Ltd.'s express consent.
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