Q2 2024 OPKO Health Inc Earnings Call

August 7, 2024

Speaker Change: © BF-WATCH TV 2021 © BF-WATCH TV 2021

Operator: Good day, and welcome to the OPKO Health second quarter 2024 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal the conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Operator: Good day, and welcome to the OPKO Health Second Quarter 2024 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then 1 on your telephone keypad. To withdraw your question, please press star, then 2. Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Speaker Change: Good day and welcome to the OPKO Health Second Quarter 2024 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero.

Operator: All participants will be in listen-only mode. Should you need assistance, please signal conference specialist by pressing the star key followed by zero.

Operator: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two.

Speaker Change: After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2.

Operator: Please note, this event is being recorded.

Yvonne Briggs: I would now like to turn the conference over to Yvonne Briggs. Please go ahead. Thank you, operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss OPKO Health financial results for the second quarter of 2024.

Speaker Change: Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.

Yvonne Briggs: Thank you, Operator, and good afternoon. This is Yvonne Briggs with LHA.

Yvonne Briggs: Thank you, Operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss OPKO Health's financial results for the second quarter of 2024.

Yvonne Briggs: Thank you all for joining today's call to discuss OPKO Health's financial results for the second quarter of 2024. I'd like to remind you that any statements made during this call by management other than statements of historical fact will be considered forward-looking and, as such, will be subject to risks and uncertainties that can materially affect the company's expected results. Those forward-looking statements include, without limitation, the various risks described in the company's SEC filings, including the annual report on Form 10-K for the year ended December 31, 2023, and its subsequently filed SEC reports.

Yvonne Briggs: I'd like to remind you that any statements made during this call by management, other than statements of historical facts, will be considered forward-looking, and, as such, will be subject to risks and uncertainties that can materially affect the company's expected results. Those forward-looking statements include, without limitations, the various risks described in the company's SEC filings, including the annual report on Form 10-K for the year ended December 31, 2023, and in subsequently filed SEC reports.

Yvonne Briggs: I'd like to remind you that any statements made during this call by management other than statements of historical fact will be considered forward-looking, and as such will be subject to risks and uncertainties that can materially affect the company's expected results.

Yvonne Briggs: Those forward-looking statements include, without limitation, the various risks described in the company's SEC filings, including the annual report on Form 10-K for the year ended December 31, 2023, and its subsequently filed SEC reports.

Yvonne Briggs: The conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 7, 2024.

OPCOTE: Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call.

Yvonne Briggs: Before we begin, let me review the format of today's call.

Yvonne Briggs: The conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 7, 2024. Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. Before we begin, let me review the format of today's call. Dr. Phillip Frost, Chairman and Chief Executive Officer, will open the call. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of BioReference Health, followed by OPKO's Pharmaceutical Business. After that, Adam Logal, OPKO's CFO, will review the company's second quarter financial results and then will open up the call to questions. Now, I'd like to turn the call over to Dr. Frost.

Phillip Frost: Dr. Philip Frost, Chairman and Chief Executive Officer, will open the call.

Speaker Change: Before we begin, let me review the format of today's call. Dr. Phillip Frost, Chairman and Chief Executive Officer, will open the call. Dr. Elias Zerhouni, Vice Chairman and President, will then provide an overview of BioReference Health, followed by OPKO's pharmaceutical business.

Elias Zerhouni: Dr. Elias Sirhooni, Vice Chairman and President, will then provide an overview of Bio-Reference Health followed by OPKO's pharmaceutical business.

Adam Logal: After that, Adam Logal, OPKO's CFO, will review the company's second quarter financial results, and then we'll open up the call to questions. Now I'd like to turn the call over to Dr. Frost.

Speaker Change: After that, Adam Logal, OPKO's CFO , will review the company's second quarter financial results and then will open up the call to questions. Now I'd like to turn the call over to Dr. Frost.

Phillip Frost: Good afternoon, and thank you for joining us today. We recently made a few announcements focused on optimizing our balance sheet and enhancing. We entered into a $250 million note purchase agreement with Healthcare Royalty that is secured by the gross profit share arrangement we have with Pfizer, our global commercial partner for N Genoa. The transaction allows us to retain a significant portion of the near-term profit share payments and also provide substantial upside opportunities long-term. We maintain rights to the full $100 million of remaining potential milestone payments from Pfizer. The proceeds provide financial flexibility to events or R&D efforts for Modex and its multi-specific antibody programs, other OPKO programs, and the option to repurchase shares of our common stock and convertible notes.

Phillip Frost: Good afternoon, and thank you for joining us today. We recently made a few announcements focused on optimizing our balance sheet and enhancing shareholder value. We entered into a $250 million note purchase agreement with Health Care Royalty that is secured by the gross profit share arrangement we have with Pfizer, our global commercial partner for Angenla. The transaction allows us to retain a significant portion of the near-term profit share payments and also provides substantial upside opportunities in the long term.

Phillip Frost: and thank you for joining us today. We recently made a few announcements focused on optimizing our balance sheet and enhancing shareholder value; we entered into a $250 million note purchase agreement with Health Care Royalty that is secured by the gross profit share arrangement we have with Pfizer, our global commercial partner for Angenla. The transaction allows us to retain a significant portion of the near-term profit share payments and also provides substantial upside opportunities in the long term.

Speaker Change: Good afternoon, and thank you for joining us today.

Speaker Change: We recently made a few announcements focused on optimizing our balance sheet and enhancing shareholder value.

Speaker Change: We entered into a $250 million note purchase agreement with Healthcare Royalty that is secured by the gross profit share arrangement we have with Pfizer, our global commercial partner for Angenla.

Speaker Change: The transaction allows us to retain a significant portion of the near-term profit share payments and also provides substantial upside opportunities long-term.

Phillip Frost: We maintain rights to the full $100 million of remaining potential milestone payments from Pfizer. The proceeds provide financial flexibility to advance our R&D efforts for MODEC and its multi-specific antibody programs, other OPKO programs, and the option to repurchase shares of our common stock and convertible notes. As you know, our board authorized a $100 million dollar share repurchase program, which, at present prices, represents approximately 10% of our shares outstanding. This share buyback program represents an attractive investment opportunity, given our confidence in the business and our strategy.

Phillip Frost: We maintain rights to the full $100 million of remaining potential milestone payments from Pfizer. The proceeds provide financial flexibility to advance our R&D efforts for MODEC and its multi-specific antibody programs, other OPKO programs, and the option to repurchase shares of our common stock and convertible notes. As you know, our board authorized a $100 million share repurchase program, which at present prices represents approximately 10% of our shares outstanding. This share buyback program represents an attractive investment opportunity given our confidence in the business and our strategy.

Speaker Change: We maintain rights to the full $100 million of remaining potential milestone payments from Pfizer.

Speaker Change: The proceeds provide financial flexibility to advance our R&D efforts for MODEX and its multi-specific antibody programs, other OPKO programs, and the option to repurchase shares of our common stock and convertible notes.

Phillip Frost: As you know, our board authorized a $100 million share repurchase program, which, at present prices, represents approximately 10% of our shares outstanding. This share buyback program represents an attractive investment opportunity given our confidence in the business and our strategy. And Genoa, our long-acting growth hormone therapy, continues to gain traction as Pfizer expands its launch, with the product now being sold globally. And Genoa competes in a large and expanding global market opportunity.

Speaker Change: As you know, our board authorized a $100 million dollar share repurchase program, which, at present prices, represents approximately 10% of our shares outstanding.

Speaker Change: This share buyback program represents an attractive investment opportunity given our confidence in the business and our strategy.

Phillip Frost: In general, our long-acting growth hormone therapy continues to gain traction as Pfizer expands its launch, with the product now being sold globally, and John Luke competes in a large and expanding global market opportunity. As mentioned on our last conference call, the FDA cleared the IND for MODEX 2001 for us to proceed to a Phase I clinical trial to treat solid tumors. Our goal is to develop a first-in-class, tetraspecific antibody that activates T-cells and survival enhancement receptors to optimize sustained cancer treatment.

Phillip Frost: Andranileth, our long-acting growth hormone therapy, continues to gain traction as Pfizer expands its long-term strategy, with the product now being sold globally, and John Luke competes in a large and expanding global market opportunity. As mentioned on our last conference call, the IND for MODEX-2001 was cleared by the FDA for us to proceed to a Phase I clinical trial to treat solid tumors. Our goal is to develop a first-in-class, Tetra-specific antibody that activates T-cells and survival enhancement receptors to optimize sustained cancer treatment.

Speaker Change: In general, our long-acting growth hormone therapy continues to gain traction as Pfizer expands its launch, with the product now being sold globally.

Speaker Change: In general, it competes in a large and expanding global market opportunity.

Phillip Frost: As mentioned on our last conference call, the IND for Modex 2001 was cleared by the FDA for us to proceed to a Phase One clinical trial to treat solid tumors. Our goal is to develop a first-in-class tetris-specific antibody that activates T-cells and survival enhancement receptors to optimize sustained cancer treatment. The first patient is expected to be dosed in the coming weeks.

Speaker Change: As mentioned on our last conference call, the IND for MODEX-2001 was cleared by the FDA for us to proceed to a Phase I clinical trial to treat solid tumors.

Speaker Change: Our goal is to develop a first-in-class, tetraspecific antibody that activates T-cells and survival enhancement receptors to optimize sustained cancer treatment. The first patient is expected to be dosed in the coming weeks.

Phillip Frost: The first patient is expected to be dosed in the coming week. In addition, we're on track to begin clinical trials of our Epstein-Barr vaccine candidate with our partner Merck later this year. Elias will provide more detail on these and other MODEX pipeline programs in a moment.

Elias Zerhouni: In addition, we're on track to begin clinical trials of our Epstein-Barr vaccine candidate with our partner Merck later this year. Elias will provide more detail on these and other Modex pipeline programs in a moment.

Speaker Change: in addition we' on track to begin clinical trials of our epstein bar our v rexin candidate with our partner merk later this year elias will provide more detail on these and other modetex pipeline programs in a moment

Phillip Frost: As for bar reference health, we're making steady progress on the return to profitability, which will accelerate when we close the announced transaction with LabCorp. We are continuing to progress our collaboration with Intera Bio to develop oral tablets with formulations of our proprietary long-acting GLP-2 peptide and oxyntomodulin analogs using Intera's proprietary N-Tab oral delivery technology. Intera recently announced in vivo PK results for oral GLP-2 tablets to treat short bowel syndrome and other GI disorders. Plasma levels compared favorably with those reported for tetraglutide agatex products. Pharmacology and incremental precade were expected early in the second half of 2024.

Phillip Frost: As for Bar Reference Health, we're making steady progress on the return to profitability, which will accelerate when we close the announced transaction with LabCorp. We are continuing to advance our collaboration with Interra Bio to develop oral tablet formulations of our proprietary long-acting GLP2 peptide and oxintamodulin analogs using Interra's proprietary NTAB oral delivery technology. Antero recently announced in vivo PK results for oral GLP2 tablets to treat short bowel syndrome and other GI disorders.

Phillip Frost: As for BioReference Health, we're making steady progress on the return to profitability, which will accelerate when we close the announced transaction with LabCorp. We are continuing to advance our collaboration with Interra Bio to develop oral tablet formulations of our proprietary long-acting GLP2 peptide and oxintamodulin analogs using Interra's proprietary NTAB oral delivery technology. Antero recently announced in vivo PK results for oral GLP2 tablets to treat short bowel syndrome and other GI disorders.

Speaker Change: As for Bar Reference Health, we are making steady progress on the return to profitability, which will accelerate when we close the announced transaction with LabCorp.

Speaker Change: We are continuing to progress our collaboration with Interra Bio to develop oral tablet formulations of our proprietary long-acting GLP2 peptide and oxintamodulin analogs using Interra's proprietary NTAB oral delivery technology.

Tara: and Tara recently announced in vivo PK results for oral GLIP2 tablets to treat short bowel syndrome and other GI disorders.

Phillip Frost: Plasma levels compared favorably with those reported for Teju Glutide, a Gatex product. Pharmacology and incremental pre-K were expected early in the second half of 2024. With that brief overview, I'll turn it over to Elias. Elias? Thank you.

Speaker Change: Plasma levels compared favorably with those reported for Tegu Glutide, a Gatex product.

Speaker Change: Pharmacology and incremental pre-K were expected early in the second half of 2024.

Elias Zerhouni: With that brief overview, I'll turn it over to Elias. Elias.

Speaker Change: With that brief overview, I'll turn it over to Elias. Elias?

Elias Zerhouni: Thank you, Phil, and good afternoon, everyone. To echo Phil's comments, we're well positioned to execute on our strategy. This includes advancing our multi-specific pipeline at MODX and streamlining bioreference health operations to return to profitability. Let me start with BioReference Health.

Elias Zerhouni: Thank you, Phil, and good afternoon everyone. To echo Phil's comments, we're well positioned to execute on our strategy. This includes advancing our multi-specific pipeline at MODX and streamlining bioreference health operations to return to profitability. Let me start with BioReference Health.

Elias Zerhouni: Thank you, Phil, and good afternoon, everyone. To echo Phil's comments, we are well positioned to execute on our strategy. This includes advancing our multi-specific pipeline at Modex and streamlining bio-reference health operations to return to profitability.

Ellias: Thank you, Phil, and good afternoon, everyone. To echo Phil's comments, we're well positioned to execute on our strategy.

Speaker Change: This includes advancing our multi-specific pipeline at MODEX and streamlining bio-reference health operations to return to profitability. Let me start with bio-reference health. We're on track to close our transaction with LabCorp in late September , early October .

Elias Zerhouni: Let me start with bio-reference health. We are on track to close our transaction with LabCorp in late September, early October. After this transaction closes, our ongoing diagnostic operations will include our national oncology and urology franchises and our full suite of testing services in New York and New Jersey. This transaction will streamline our remaining diagnostic business by enhancing our focus on core testing operations and supporting our efforts to reestablish profitability. As a non-going initiative, we continue to improve Bio-Reference's performance and in turn build value. Our goals remain clear, and that is to reduce costs to improve efficiency and to enhance productivity, as well as to drive top-line growth.

Elias Zerhouni: We're on track to close our transaction with LabCorp in late September or early October. After this transaction closes, our ongoing diagnostic operations will include our national oncology and urology franchises and our full suite of testing services in New York and New Jersey. This transaction will streamline our remaining diagnostic business by enhancing our focus on core testing operations and supporting our efforts to re-establish profitability. As an ongoing initiative, we continue to improve bio-reference performance and, in turn, build value.

Speaker Change: After this transaction closes, our ongoing diagnostic operations will include our national oncology and urology franchises and our full suite of testing services in New York and New Jersey.

Speaker Change: This transaction will streamline our remaining diagnostic business by enhancing our focus on core testing operations and supporting our efforts to re-establish profitability.

Speaker Change: As an ongoing initiative, we continue to improve BioReference's performance and in turn build value.

Elias Zerhouni: Our goals remain clear, and that is to reduce costs, improve efficiency, and enhance productivity, as well as to drive top-line growth. For instance, at the end of Q2... Our FTE number at BioReference was 2,697, and this will drop to approximately 2100 following the transfer of FTEs to LabCorp at the closing of the transaction. This geographically focusing of our operations will help further reduce our cost structures in the coming quarters.

Speaker Change: Our goals remain clear, and that is to reduce costs, to improve efficiency, and to enhance productivity, as well as to drive top-line growth. For instance, at the end of Q2,

Elias Zerhouni: For instance, at the end of Q2, our FTE number at Bio-Reference was 2697, and this will drop to approximately 2100 following the transfer of FTEs to LabCorp as closing of the transaction. This geographic refocusing of our operations will help further reduce our constructors and coming quarters.

Speaker Change: Our FTE number at BioReference was 2,697, and this will drop to approximately 2,100 following the transfer of FTEs to LabCorp at closing of the transaction.

Speaker Change: This geographic refocusing of our operations will help further reduce our cost structures and coming quarters.

Elias Zerhouni: Now, oncology remains a growing and high-value segment of the diagnostic business. In the second quarter, testing volume increased 8% and revenue overall increased 6% versus the year-ago quarter due to demand for our innovative platform and competitive turnaround ties. As I mentioned last quarter, the growth in this segment is being driven by collaborations with large cancer centers and mid-level health systems. We continue to expand these relationships, as it is a costly proposition for our health system to run the specialty oncology tests in-house. Additionally, we grew our oncology menu in the second quarter with the addition of IUC's names for neuroendocrine, arabdoid, and gastric markers and moved some of our somatic markers to new advanced testing platforms. This enables us to stay best in class with our portfolio and brings value to our clients and the patients deserve.

Elias Zerhouni: Now, oncology remains a growing and high-value segment of the diagnostics business. In the second quarter, testing volume increased 8%, and revenue overall increased 6% versus the year-ago quarter. Due to demand for our innovative platform and competitive turnaround. As I mentioned last quarter, growth in this segment is being driven by collaborations with large cancer centers and mid-level health systems. We continue to expand these relationships as it is a costly proposition for a health system to run these specialty oncology tests in-house.

Elias Zerhouni: Additionally, we grew our oncology menu in the second quarter with the addition of IHC stains for neuroendocrine, rhabdoid, and gastric markers and moved some of our somatic markers to new advanced testing classes. This enables us to stay best in class with our portfolio and brings value to our clients and the patients they serve. Our 4K score test for prostate cancer continues to perform well.

Speaker Change: Now, oncology remains a growing and high-value segment of the diagnostics business.

Speaker Change: In the second quarter, testing volume increased 8% and revenue overall increased 6% versus the year-ago quarter, due to demand for our innovative platform and competitive turnaround times.

Speaker Change: As I mentioned last quarter, the growth in this segment is being driven by collaborations with large cancer centers and mid-level health systems.

Speaker Change: We continue to expand these relationships as it is a costly proposition for a health system to run these specialty oncology tests in-house.

Speaker Change: Additionally, we grew our oncology menu in the second quarter with the addition of IHC stains for neuroendocrine, arabdoid, and gastric markers, and moved some of our somatic markers to new advanced testing platforms.

Speaker Change: This enables us to stay best in class with our portfolio and brings value to our clients and the patients they serve.

Elias Zerhouni: Our 4K score test for prostate cancer continues to perform well.

Speaker Change: Our 4K score test for prostate cancer continues to perform well.

Elias Zerhouni: Now, moving to our pharmaceutical segment, I'd like to start with MODX programs, and specifically the MDX-2001 program that was mentioned by Phil, which has been approved by FDA to progress into the clinical stage. We expect to dose our first patient in the phase one trial for our tetraspecific laser program for solid tumors in the coming week. This Phase 1 open-label trial is expected to enroll 45 cancer patients with a variety of solid tumors, including lung, breast, prostate, and pancreatic, with the goal to focus on certain tumor types that are responding to treatment and then expand the trial accordingly. We anticipate a total of six clinical sites to evaluate safety, tolerability, and pharmacokinetics, as well as early anti-tumor activity. Two sites are already enrolling patients. And for more, I will come online very promptly.

Elias Zerhouni: Now, moving to our pharmaceutical segment, I'd like to start with MOTAX programs and specifically the MDX 2001 program that was mentioned by Phil, which has been approved by FDA to progress into the clinical stage. We expected those at first patients in the Phase 1 trial for our Tetra-specific laser program for solid tumors in the coming weeks. This Phase 1 open-label trial is expected to involve 45 cancer patients with a variety of solid tumors, including lung, breast, prostate, and pancreatic cancer. with a goal to focus on certain tumor types that are responding to treatment and then expand the trial accordingly.

Speaker Change: Now, moving to our pharmaceutical segment.

Speaker Change: I'd like to start with MODEX programs, and specifically the MDX-2001 program that was mentioned by Phil, which has been approved by FDA to progress into the clinical stage.

Speaker Change: We expect to dose our first patient in the Phase 1 trial for our tetraspecific laser program for solid tumors in the coming weeks.

Speaker Change: This Phase 1 open-label trial is expected to enroll 45 cancer patients with a variety of solid tumors, including lung, breast, prostate, and pancreatic cancers.

Speaker Change: with a goal to focus on certain tumor types that are responding to treatment and then expand the trial accordingly.

Elias Zerhouni: We anticipate the total six clinical sites to evaluate safety, tolerability, and pharmacokinetics, as well as early antitumor activity. Two sites are already in rolling patients, and four more will come online very promptly. In addition, we look forward to advancing our other immunorecology programs through IND and APNIC studies and expect to enter the clinic next year with an immune modulator, multi-specific antibody known as MDX 2004 that could potentially be used in a large number of oncology and non-ecology indications. We continue to actively evaluate possible partnerships for our portfolio assets, seeking non-value to find funding for several of our programs. Another program we expect to enter the clinic this year or early next year is MDX201, which is our Epstein Bar Virus multivalent nanoparticle vaccine.

Speaker Change: We anticipate a total of six clinical sites to evaluate safety, tolerability, and pharmacokinetics, as well as early anti-tumor activity. Two sites are already enrolling patients.

Speaker Change: and

Elias Zerhouni: In addition, we look forward to advancing our other immuno-oncology programs through IND-enabling studies and expect to enter the clinic next year with an immune modulator multispecific antibody known as MDX2004 that could potentially be used in a large number of oncology and non-oncology indications. We continue to actively evaluate possible partnerships for our portfolio assets, seeking non-dilutive funding for several of our programs. Another program we expect to enter the clinic this year or early next year is MDX2201, which is our Epstein-Barr virus multivalent nanoparticle vaccine.

Speaker Change: For more, I will come online very promptly.

Speaker Change: In addition, we look forward to advancing our other immuno-oncology programs through IND and APIC studies.

Speaker Change: and expect to enter the clinic next year with an immune modulator, multi-specific antibody known as MDX2004 that could potentially be used in a large number of oncology and non-oncology indications.

Speaker Change: We continue to actively evaluate possible partnerships for our portfolio assets, seeking non-dilutive funding for several of our programs.

Speaker Change: Another program we expect to enter the clinic this year or early next year is MDX2201, which is our Epstein-Barr virus multivalent nanoparticle vaccine.

Elias Zerhouni: Merck is our collaboration partner who funds all preclinical work performed by the MEDEX team until IND, at which time Merck will assume all development and commercialization aspects of this novel vaccine for EBV. Pending regulatory clearance, our goal is to begin studies in mid-2024 or early 2026. We also have a very active collaboration with BARDA to develop our multispecific antibodies against known variants of SARS-CoV-2 for the treatment and prevention of COVID-19. This program is also progressing very well and is entering the pre-IND enabling stage of development.

Elias Zerhouni: Merck is our collaboration partner who funds all preclinical work performed by the MEDEX team until IND, at which time Merck will assume all development and commercialization aspects of this novel vaccine for EBV. Pending regulatory clearance, our goal is to begin studies in mid-2024 or early 2026. We also have a very active collaboration with BARDA to develop our multi-specific antibodies against known variants of SARS-CoV-2 for the treatment and prevention of COVID-19. This program is also progressing very well and is entering the pre-IND enabling stage of development.

Elias Zerhouni: Merck is our collaboration partner who funds all clinical work performed by the MUDX team until IND. At which time Merck will assume all developmental crystallization aspects of this novel vaccine for EBV. Depending on regulatory clearance, our goal is to begin studies in mid 2024, early 2025.

Speaker Change: Merck is our collaboration partner who funds all preclinical work performed by the MedEx team until IND, at which time Merck will assume all development and commercialization aspects of this novel vaccine for EBV.

Speaker Change: Pending regulatory clearance, our goal is to begin studies in mid-2024, early 2025.

Elias Zerhouni: We also have a very active collaboration with BARDA to develop our multi-specific antibodies against known variants of SARS-CoV-2 for the treatment and prevention of COVID-19. This program is also progressing very well and is entering the pre-IND enabling station development. BARDA, as we mentioned before, granted us $59 million to fund R&D and clinical evaluation to Phase One. Additional funding of up to 109 million may be available to accelerate the COVID program and target other defense threat threats, as well as develop a platform with gene-based delivery methods for use against future pandemics.

Speaker Change: We also have a very active collaboration with BARDA.

Speaker Change: to develop our multi-specific antibodies against known variants of SARS-CoV-2 for the treatment and prevention of COVID-19. This program is also progressing very well and is entering the pre-IND enabling stage of development.

Elias Zerhouni: BARTA, as we mentioned before, granted us $59 million to fund R&D and clinical evaluation through Phase 1. Additional funding of up to $109 million may be available to accelerate the COVID program and target other biodefense threats, as well as develop a platform with gene-based delivery methods for use against future pandemics. Now, switching gears to Angenla, Pfizer has launched a pediatric long-acting growth hormone drug in all major global markets, and we expect Pfizer to continue to penetrate markets and gain share for this once-weekly drug as patients shift from their daily product.

Speaker Change: BARTA, as we mentioned before, granted us $59 million to fund R&D and clinical evaluation through Phase 1.

Speaker Change: Additional funding of up to $109 million may be available to accelerate the COVID program and target other biodefense threats as well as develop a platform with gene-based delivery methods for use against future pandemics.

Elias Zerhouni: Now switching gears, and in general, Pfizer has launched a pediatric long-acting growth hormone drug in all major global markets, and we expect Pfizer to continue to penetrate markets and gain share for this once-weekly drug as patients shift from the daily products. We're working with Pfizer on two additional indications, including growth hormone deficiency in adults and other pediatric applications. As you know, UPCO is entitled to an additional $100 million in potential milestone payments related to these two indications. Finally, Rialdi continues to perform as expected, with new evidence showing its potential to improve outcomes in chronic kidney disease three and four stage patients with secondary hyperparadritis.

Speaker Change: Now, switching gears to Angenla, Pfizer has launched a pediatric long-acting growth hormone drug in all major global markets, and we expect Pfizer to continue to penetrate markets and gain share for this once-weekly drug as patients shift from their daily products.

Elias Zerhouni: We're working with Pfizer on two additional indications, including growth hormone deficiency in adults and other pediatric applications. As you know, OPKO is entitled to an additional $100 million in potential milestone payments related to these two indications. Finally, Royality continues to perform as expected, with new evidence showing its potential to improve outcomes in chronic kidney disease three and four stage patients with secondary hyperparathyroidism. So, in summary, I think we've made significant progress in both segments of the business as we get closer to returning BioReference Health to profitability and, in parallel, advancing our promising Modex pipeline as programs enter the clinic and progress through clinical testing. I'll now turn the call over to Adam Logal to discuss our second quarter financial results. Adam?

Speaker Change: We're working with Pfizer on two additional indications, including growth hormone deficiency in adults and other pediatric applications. As you know, OPKO is entitled to an additional $100 million in potential milestone payments related to these two indications.

Speaker Change: Finally, Royalty continues to perform as expected, with new evidence showing its potential to improve outcomes in chronic kidney disease 3 and 4 stage patients with secondary hyperparathyroidism.

Elias Zerhouni: So, in summary, I think we've made significant progress in both segments of the business as we get closer to returning by reference help to profitability and, in parallel, advancing our promising MODX pipeline as programs enter the clinic and progress through clinical tests.

Speaker Change: So, in summary, I think we've made significant progress in both segments of the business as we get closer to returning BioReference Health to profitability and in parallel advancing our promising MODEX pipeline as programs enter the clinic and progress through clinical testing.

Adam Logal: I will now turn the call over to Adam Logal to discuss our second quarter financial results. Adam?

Speaker Change: I will now turn the call over to Adam Logal to discuss our second quarter financial results. Adam.

Adam Logal: Thank you, Elias. As Phil and Elias have discussed, the first half of 2024 was transformational for our balance sheet as we position ourselves to realize and demonstrate the inherent value of our assets for our shareholders. We initiated and completed five significant transactions, which Phil and Elias have already discussed in part, including the financing of our convertible notes in January, which allowed us to extend the maturity of our notes, repurchase 55 million shares of common stock, and added approximately $25 million of cash to our balance sheet, while working to realize the significant value of our underlying asset.

Adam Logal: As Phil and Elias have discussed, the first half of 2024 was transformational for our balance sheet as we position ourselves to realize and demonstrate the inherent value of our assets for our shareholders. We initiated and completed five significant transactions which Phil and Elias have already discussed in part, including the refinancing of our convertible notes in January, which allowed us to extend the maturity of our notes, repurchase 55 million shares of common stock, and add approximately $25 million of cash to our balance sheet while working to realize the significant value of our underlying assets. We then announced the LabCorp transaction to position BioReference to return to profitable growth through focus on certain strategic and geographic customer segments, as well as demonstrate the value of the remaining business of BioReference.

Adam Logal: As Phil and Elias have discussed, the first half of 2024 was transformational for our balance sheet as we position ourselves to realize and demonstrate the inherent value of our assets for our shareholders. We initiated and completed five significant transactions, which Phil and Elias have already discussed in part, including the refinancing of our convertible notes in January, which allowed us to extend the maturity of our notes, repurchase 55 million shares of common stock, and add approximately $25 million of cash to our balance sheet while working to realize the significant value of our underlying assets. We then announced the LabCorp transaction to position BioReference to return to profitable growth through focus on certain strategic and geographic customer segments, as well as to demonstrate the value of the remaining business of BioReference.

Speaker Change: Thank you, Elias. As Phil and Elias have discussed, the first half of 2024 was transformational for our balance sheet as we position ourselves to realize and demonstrate the inherent value of our assets for our shareholders.

Speaker Change: We initiated and completed five significant transactions, which Phil and Elias have already discussed in part, including

Speaker Change: The refinancing of our convertible notes in January , which allowed us to extend the maturity of our notes, repurchase 55 million shares of common stock, and added approximately $25 million of cash to our balance sheet while working to realize the significant value of our underlying assets.

Adam Logal: We then announced the LabCorp transaction to position file reference to return to profitable growth through focus on certain strategic and geographic customer segments, as well as demonstrate the value of remaining business of file reference. We announced the healthcare royalty financing transaction recently, pulling forward $250 million of cash while maintaining significant upside in the gross profit share payments and all remaining milestone payments. Fourth, we announced an additional common stock buyback of up to $100 million. And finally, we've begun to monetize a portion of our holdings in GDX. We look at all options of enhancing shareholder value, and we'll continue to execute operational through strategic transactions like the ones I just mentioned.

Speaker Change: We then announced the LabCorp transaction to position BioReference to return to profitable growth through focus on certain strategic and geographic customer segments, as well as demonstrate the value of the remaining business of BioReference.

Adam Logal: We announced the health care royalty financing transaction recently, pulling forward $250 million of cash while maintaining significant upside in the gross profit share payments at all remaining milestones. Fourth, we announced an additional common stock buyback of up to $100 million, and finally, we've begun to monetize a portion of our holdings in GNDX. We look at all options for enhancing shareholder value and will continue to execute operations through strategic transactions like the ones I just mentioned.

Adam Logal: We announced the health care royalty financing transaction recently, pulling forward $250 million of cash while maintaining significant upside in the gross profit share payments and all remaining milestones. Fourth, we announced an additional common stock buyback of up to $100 million, and finally, we've begun to monetize a portion of our holdings in GNDX. We look at all options for enhancing shareholder value and will continue to execute operations through strategic transactions like the ones I just mentioned.

Speaker Change: We announced the health care royalty financing transaction recently, pulling forward 250 million dollars of cash while maintaining significant upside in the gross profit share payments and all remaining milestone payments.

Speaker Change: Thank you for joining us.

Speaker Change: Fourth, we announced an additional common stock buyback of up to $100 million. And finally, we've begun to monetize a portion of our holdings in GDX.

Speaker Change: We look at all options of enhancing shareholder value and will continue to execute operational through strategic transactions like the ones I just mentioned.

Adam Logal: This includes opportunity to realize the inherent value of our assets and through the return of capital to shareholders through our stock buyback program, as well as repurchasing our convertible notes as market conditions allow. We expect to have a significant cash balance, which we'll use to invest in our highest priority R&D programs and to fund prudent equity repurchases.

Adam Logal: This includes the opportunity to realize the inherent value of our assets and through the return of capital to shareholders through our stock buyback program, as well as repurchasing our convertible notes as market conditions allow. We expect to have a significant cash balance, which we will use to invest in our highest priority R&D programs and to fund prudent equity repurchase. Before I move to the financial results for the quarter, I wanted to summarize the key terms of our recent Healthcare Royalty Trends Act.

Speaker Change: This includes opportunity to realize the inherent value of our assets and through the return of capital to shareholders through our stock buyback program, as well as repurchasing our convertible notes as market conditions allow.

Speaker Change: We expect to have a significant cash balance which we will use to invest in our highest priority R&D programs and to fund prudent equity repurchases.

Adam Logal: Be a fore I move to the financial results for the quarter. What are the summarized key terms of our recent healthcare royalty transaction? Through this agreement, we've accelerated the value realization of a portion of our partnership with Pfizer while retaining $100 million of milestone payments. The agreement also allows us to retain near-term upside and the long-term potential of the collaboration at a cost of capital below our benchmarks. The transaction was structured as a royalty bond secured by the gross profit share payments we received from Pfizer. This will be accounted for as debt, meaning the balance sheet will reflect the cash and principal balance of what we received from healthcare royalty.

Speaker Change: Before I move to the financial results for the quarter, I wanted to summarize the key terms of our recent healthcare royalty transaction.

Adam Logal: Through this agreement, we've accelerated the value realization of a portion of our partnership with Pfizer while retaining $100 million in milestone payments. The agreement also allows us to retain near-term upside and the long-term potential of the collaboration at a cost of capital below our benches.

Adam Logal: Through this agreement, we've accelerated the value realization of a portion of our partnership with Pfizer while retaining $100 million in milestone pay. The agreement also allows us to retain near-term upside and the long-term potential of the collaboration at a cost of capital below our benches.

Speaker Change: Through this agreement, we've accelerated the value realization of a portion of our partnership with Pfizer while retaining $100 million of milestone payments.

Speaker Change: The agreement also allows us to retain near-term upside and the long-term potential of the collaboration at a cost of capital below our benchmarks.

Adam Logal: The transaction was structured as a royalty bond secured by the gross profit share payments we received from Pfizer. This will be accounted for as debt, meaning the balance sheet will reflect the cash and principal balance of what we receive from health care royalties. Revenue, Gross Margin, and Operating Income will continue to reflect the economics of our existing relationship with Pfizer. However, interest expense will increase as a result of this financing. For the first four years, if the payments received from Pfizer exceed interest expense, all excess will be paid to OPKO. Shortfalls, if any, will be treated as payments in kind and will increase the principal balance.

Adam Logal: The transaction was structured as a royalty bond secured by the gross profit share payments we received from Pfizer. This will be accounted for as debt, meaning the balance sheet will reflect the cash and principal balance of what we receive from health care royalties. Revenue, gross margin, and operating income will continue to reflect the economics of our existing relationship with Pfizer. However, interest expense will increase as a result of this financing. For the first four years, if the payments received from Pfizer exceed interest expense, all excess will be paid to OPKO. Shortfalls, if any, will be treated as payments in kind and will increase the principal balance.

Speaker Change: The transaction was structured as a royalty bond secured by the gross profit share payments we received from Pfizer. This will be accounted for as debt, meaning the balance sheet will reflect the cash and principal balance of what we received from health care royalty.

Adam Logal: Revenue, gross margin, and operating income will continue to reflect the economics of our existing relationship with Pfizer. However, interest expense will increase as a result of this financing. For interest expense, all excess will be paid to OpCo. Shortfalls, if any, will be treated as payments in kind and increase the principal balance. After the first four years, all payments for Pfizer will be retained by Healthcare Royalty. First, repaying interest in any excess to pay down the principal; again, with any interest shortfalls being treated as payments in kind, accruing to principal. When considering our internal forecast and base case model, we anticipate the royalty bond will be fully repaid within eight years, with our downside models showing repayment within 10 years.

Speaker Change: Revenue, gross margin, and operating income will continue to reflect the economics of our existing relationship with Pfizer. However, interest expense will increase as a result of this financing.

Speaker Change: For the first four years, if the payments received from Pfizer exceeds interest expense, all excess will be paid to OPKO. Shortfalls, if any, will be treated as payments in kind and increase the principal balance.

Adam Logal: After the first four years, all payments from Pfizer will be retained by Health Care Royalty, first repaying interest and any excess to pay down the principal, again with any interest shortfalls being treated as payments in kind, accruing to principal. When considering our internal forecast and base case model, we anticipate the royalty bond will be fully repaid within eight years, with our downside models showing repayment within ten years. The interest rate is based on SOFR plus 7.5%, with a 4% SOFR.

Speaker Change: After the first four years, all payments from Pfizer will be retained by health care royalty, first repaying interest and any excess to pay down the principal. Again, with any interest, shortfall is being treated as payments in kind, accruing to principal.

Speaker Change: When considering our internal forecast and base case model, we anticipate the royalty bond will be fully repaid within 8 years, with our downside models showing repayment within 10 years.

Adam Logal: The interest rate is based on so-for plus 7.5% with a 4% so-for-for-for.

Speaker Change: The interest rate is based on SOFR plus 7.5%, with a 4% SOFR floor.

Adam Logal: Now, moving to the financial results of our diagnostic segment, revenue increased 2% to $129.4 million for Q2 2024 compared with $127.1 million for the 2023 period. This increase was driven by strong volume and price growth in our oncology segment, partially offset by declines in our women's health and clinical testing businesses. Cost and expenses decreased 9% or $15.3 million to $156 million for the second quarter of 2024 from $171.3 million for the 2023 period. Operating loss for our diagnostic segment narrowed by 40% to $26.6 million for the second quarter of 2024 compared to the second quarter of 2023's $44.3 million operating loss.

Adam Logal: Now, moving to the financial results of our diagnostics segment, revenue increased 2% to $129.4 million for Q2 2024 compared with $127.1 million for the 2023 period. This increase was driven by strong volume and price growth in our oncology segment, partially offset by declines in our women's health in clinical testing. Costs and expenses decreased 9% or $15.3 million to $156 million for the second quarter of 2024 from $171.3 million for the 2023 period.

Adam Logal: Now, moving to the financial results of our diagnostic segment, revenue increased 2% to $129.4 million for Q2 2024 compared with $127.1 million for the 2023 period. This increase was driven by strong volume and price growth in our oncology segment, partially offset by declines in our women's health and clinical testing segments. Operating loss for our diagnostic segment narrowed by 40% to $26.6 million for the second quarter of 2024 compared to the second quarter of 2023's $44.3 million operating loss. sequentially, we also saw an improvement in operating loss of $7.8 million, reflecting the realization of the cost reduction programs outlined last quarter.

Speaker Change: Now, moving to the financial results of our Diagnostics segment.

Speaker Change: revenue increasase two percent to one hundred and twenty nine point four million dollars for q two two thousand and twenty four compared with one hundred and twenty seven point one million dollars for the two thousand andtwenty three period

Speaker Change: This increase was driven by strong volume and price growth in our oncology segment, partially offset by declines in our women's health and clinical testing businesses.

Speaker Change: Costs and expenses decreased 9%, or $15.3 million, to $156 million for the second quarter of 2024, from $171.3 million for the 2023 period.

Adam Logal: Operating loss for our diagnostic segment narrowed by 40% to $26.6 million for the second quarter of 2024 compared to the second quarter of 2023's $44.3 million operating loss. Additionally, we also saw an improvement in operating loss of $7.8 million, reflecting the realization of the cost reduction programs outlined last quarter.

Speaker Change: Operating loss for our diagnostic segment narrowed by 40% to $26.6 million for the second quarter of 2024 compared to the second quarter of 2023's $44.3 million operating loss.

Adam Logal: Sequentially, we also saw an operating improvement in operating loss of $7.8 million, reflecting the realization of the cost reduction programs outlined last quarter. Revenue from the assets being sold to LabCorp represented $25.5 million of revenue, and related costs and expenses total $32.5 million during the second quarter of 2024. Depreciation and amortization expense for the diagnostic segment were $6.2 million in $8.6 million for the 2024 and 2023 periods, respectively. The team by our reference continues to work tirelessly to execute our plan to return this business to profitability, and they continue to make significant strides toward that objective.

Speaker Change: Sequentially, we also saw an improvement in operating loss of $7.8 million, reflecting the realization of the cost reduction programs outlined last quarter.

Adam Logal: Revenue from the assets being sold to LabCorp represented $25.5 million of revenue, and related costs and expenses totaled $32.5 million during the second quarter of 2024. Depreciation and amortization expense for the diagnostic segment were $6.2 million and $8.6 million for the 2024 and 2023 periods, respectively. The team at BioReference continues to work tirelessly to execute our plan to return this business to profitability, and they continue to make significant strides toward that objective. I'll provide some additional clarity on the details and timing of these significant improvements when I provide guidance in a few moments.

Speaker Change: Revenue from the assets being sold to LabCorp represented $25.5 million.

Speaker Change: of Revenue and Related Costs and Expenses totaled $32.5 million.

Speaker Change: during the second quarter of 2024.

Speaker Change: Depreciation and amortization expense for the Diagnostics segment were $6.2 million and $8.6 million for the 2024 and 2023 periods, respectively.

Speaker Change: The team at BioReference continues to work tirelessly to execute our plan to return this business to profitability, and they continue to make significant strides toward that objective.

Adam Logal: I'll provide some additional clarity on the details and timing of these significant improvements when I provide guidance in a few moments.

Speaker Change: I'll provide some additional clarity on the details and timing of these significant improvements when I provide guidance in a few moments.

Adam Logal: Moving to our pharmaceutical segment, revenue was $52.8 million for the second quarter of 2024 compared with $138.4 million for the 2023 period. As a reminder, the 2023 period included a $90 million milestone payment from Pfizer for the regulatory approval of Ingenla in the US. Revenue from products, including our international pharmaceutical businesses, was $40.5 million compared to $43.5 million for the comparable period of 23. Despite the challenging foreign currency environment, the profitability profile of the business approved against our expectations. Product revenue includes revenue from royalty of $7.2 million, which was similar to 2023's $7.7 million, reflecting a slight decrease in the number of bottles shipped, partially offset by increased pricing.

Adam Logal: Moving to our pharmaceutical segment, revenue was $52.8 million for the second quarter of 2024, compared with $138.4 million for the 2023 period. As a reminder, the 2023 period included a $90 million milestone payment from Pfizer for the regulatory approval of Ingenla in the U.S. Revenue from products, including our international pharmaceutical businesses, was $40.5 million, compared to $43.5 million for the comparable period of 23. Despite the challenging foreign currency environment, the profitability profile of the business was in line with our expectations.

Speaker Change: Moving to our pharmaceutical segment, revenue was 52.8 million dollars for the second quarter of 2024 compared with 138.4 million dollars for the 2023 period.

Speaker Change: As a reminder, the 2023 period included a $90 million milestone payment from Pfizer for the regulatory approval of Ingenla in the U.S.

Speaker Change: Revenue from products, including our international pharmaceutical businesses, was $40.5 million, compared to $43.5 million for the comparable period of 23.

Speaker Change: Despite the challenging foreign currency environment, the profitability profile of the business approved against our expectations.

Adam Logal: Product revenue includes revenue from royalties of $7.2 million, which was similar to 2023's $7.7 million, reflecting a slight decrease in the number of bottles shipped, partially offset by increased price. Revenue from the transfer of IP was $12.3 million for the second quarter of 2024, compared to $94.9 million for the 2023 quarter, which, as I mentioned, included $90 million from Pfizer for the US regulatory approval of Ingemi. Our U.S. gross profit share from Pfizer was $6.3 million during the second quarter of 2024, compared to $3.8 million for the 2023 period.

Adam Logal: Product revenue includes revenue from royalties of $7.2 million, which was similar to 2023's $7.7 million, reflecting a slight decrease in the number of bottles shipped, partially offset by increased price. Revenue from the transfer of IP was $12.3 million in the second quarter of 2024, compared to $94.9 million for the 2023 quarter, which, as I mentioned, included $90 million from Pfizer for the US regulatory approval of InGemli. Our U.S. gross profit share from Pfizer was $6.3 million during the second quarter of 2024, compared to $3.8 million for the 2023 period.

Speaker Change: product revenue includes revenue from r of seven point two million dollars which was similar to twothousand and twenty three seven point seven million reflecting a slight decrease in the number of botle shift partially offset by increased pricing

Adam Logal: Revenue from the transfer of IP was $12.3 million the second quarter of 2024 compared to $94.9 million for the 2023 quarter, which, as I mentioned, included $90 million from Pfizer for the US regulatory approval of Ingenla.

Speaker Change: Revenue from the transfer of IP was $12.3 million dollars the second quarter of 2024 compared to $94.9 million for the 2023 quarter which as I mentioned included $90 million dollars from Pfizer for the U.S. regulatory approval of Ingenla.

Adam Logal: Our U.S. Group's profit share from Pfizer with $6.3 million during the second quarter of 2024 compared to $3.8 million for the 2023 period. In addition, the second quarter of 2024 includes $5 million of other IP revenue related to our Barta agreement. We have $24.7 million for the 2023 period. Research and development expenses were $23.7 million compared to $17.5 million a year ago. Research and development expense increased as a result of our activities for the MODX development programs, including the recently commenced Phase 1 clinical trial for our first immuno-oncology program. The resulting operating loss for the quarter and the June 30, 2024, was $24.8 million compared with operating income of $63.3 million for the second quarter of 2023.

Speaker Change: Our U.S. gross profit share from Pfizer was $6.3 million during the second quarter of 2024, compared to $3.8 million for the 2023 period.

Adam Logal: In addition, the second quarter of 2024 includes $5 million of other IP revenue related to our BARDA agreement. Costs and expenses for our pharmaceutical segment were $77.6 million for the second quarter of 2024, compared with $74.7 million for the 2023 period. Research and development expenses were $23.7 million compared to $17.5 million a year ago. Research and development expenses increased as a result of our activities for the MODEX development programs, including the recently commenced phase one clinical trial for our first immuno-oncology program.

Speaker Change: In addition, the second quarter of 2024 includes $5 million of other IP revenue related to our BARDA agreement.

Speaker Change: Costs and expenses for our pharmaceutical segment were $77.6 million for the second quarter of 2024, compared with $74.7 million for the 2023 period.

Speaker Change: Research and development expenses were $23.7 million compared to $17.5 million a year ago.

Speaker Change: Research and development expense increased as a result of our activities for the MODEX development programs, including the recently commenced Phase I clinical trial for our first immuno-oncology program.

Adam Logal: The resulting operating loss for the quarter ended June 30, 2024, was $24.8 million, compared with operating income of $63.3 million for the second quarter of 2023. Depreciation and Amortization Expense for the Pharmaceutical Segment Related to Tangible Assets were unchanged at $17.9 and $17.8 million for the second quarter of 2024 and the second quarter of 2023. Turning to our consolidated financial results, for the second quarter of 2024, we reported a net loss of $10.3 million, or one penny per share, compared with a net loss of $19.6 million, or three cents per share, for the 2023 period.

Adam Logal: The resulting operating loss for the quarter ended June 30, 2024, was $24.8 million compared with operating income of $63.3 million for the second quarter of 2023. Depreciation and Amortization Expense for the Pharmaceutical Segment Related to Intangible Assets were unchanged at $17.9 and $17.8 million for the second quarter of 2024 and the second quarter of 2023. Turning to our consolidated financial results, for the second quarter of 2024, we reported a net loss of $10.3 million, or one penny per share, compared with a net loss of $19.6 million, or three cents per share, for the 2023 period.

Speaker Change: The resulting operating loss for the quarter ended June 30, 2024, was $24.8 million, compared with operating income of $63.3 million for the second quarter of 2023.

Adam Logal: Depreciation and the amortization expense for the pharmaceutical segment related to contingent assets were unchanged at $17.9 million and $17.8 million for the 2024 and 2023 second quarters.

Speaker Change: Depreciation and the Amortization Expense for the Pharmaceutical Segment Related to Tangible Assets

Speaker Change: were unchanged at $17.9 and $17.8 million for the 2024 and 2023 second quarters.

Adam Logal: Turning to our consolidated financial results for the second quarter of 2024, we've reported a net loss of $10.3 million, or $1 penny per share, compared with a net loss of $19.6 million, or $3 cents per share, for the 2023 period. Net loss for the second quarter of 2024 included a non-cash unrealized gain on our investment in GDX of $60.5 million compared to a non-realized loss of $19.9 million for the 2023 period. In addition, as I've mentioned, the 2023 period benefited from a non-recurring $90 million milestone payment from Pfizer.

Adam Logal: The net loss for the second quarter of 2024 included a non-cash unrealized gain on our investment in GeneDx of $60.5 million compared to a non-realized loss of $19.9 million for the 2023 period. In addition, as I've mentioned, the 2023 period benefited from a non-recurring $90 million milestone payment from Pfizer. As we look ahead, providing financial guidance with the following assumptions for our pharmaceutical segment, Global Sales of Genotropin for the first half of 2024, as reported by Pfizer, were $349 million. Pfizer has not separately reported sales of Ingenla.

Speaker Change: Turning to our consolidated financial results, for the second quarter of 2024, we've reported a net loss of $10.3 million, or one penny per share, compared with a net loss of $19.6 million, or three cents per share, for the 2023 period.

Speaker Change: Net loss for the second quarter of 2024 included a non-cash, unrealized gain on our investment in GeneDx of $60.5 million, compared to a non-realized loss of $19.9 million for the 2023 period.

Speaker Change: In addition, as I've mentioned, the 2023 period benefited from the non-recurring $90 million milestone payment from Pfizer.

Adam Logal: As we look ahead, providing financial guidance with the following assumptions. For our pharmaceutical segment, global sales of Genotropin for the first half of 2024, as reported by Pfizer, were $349 million. Pfizer has not separately reported sales of NGEMLA. However, we continue to observe consistent prescription growth globally for NGEMLA, as reported by both IQVIA and Symphony. We were pleased to see that Pfizer has begun to realize the cost benefits of the increased manufacturing scale of NGEMLA during the second quarter. As a result, we believe that the gross profit share payments beginning late in the third quarter will reflect this improvement in gross profit for the product.

Speaker Change: as we look ahead, providing financial guidance with the following assumptions.

Speaker Change: For our pharmaceutical segment, Global Sales of Genotropin

Speaker Change: For the first half of 2024, as reported by Pfizer, we're $349 million.

Adam Logal: However, we continue to observe consistent prescription growth globally for Ingenla, as reported by both IQVIA and Symfony. We were pleased to see that Pfizer had begun to realize the cost benefits of the increased manufacturing scale of Ingenla during the second quarter, and as a result, we believe that the gross profit share payments beginning late in the third quarter will reflect this improvement in gross profit for the product. As such, we expect to receive gross profit share payments from Pfizer of $7 to $9 million in Q3 and $15 to $20 million for the full second half of 2024. Additionally, we assume a stable foreign currency exchange rate for our ex-U.S. pharmaceutical business.

Adam Logal: However, we continue to observe consistent prescription growth globally for Ingenla, as reported by both IQVIA and SymphoM. We were pleased to see that Pfizer had begun to realize the cost benefits of the increased manufacturing scale of Ingenla during the second quarter. And as a result, we believe that the gross profit share payments beginning late in the third quarter will reflect this improvement in gross profit for the product. As such, we expect to receive gross profit share payments from Pfizer of $7 to $9 million in Q3 and $15 to $20 million for the full second half of 2024.

Speaker Change: Pfizer has not separately reported sales of Ingenla, however we continue to observe consistent prescription growth globally for Ingenla as reported by both IQVIA and Symfony.

Speaker Change: We were pleased to see that Pfizer has begun to realize the cost benefits of the increased manufacturing scale of Ingenla during the second quarter. And as a result, we believe that the gross profit share payments beginning late in the third quarter will reflect this improvement in gross profit for the product.

Adam Logal: As such, we expect to receive gross profit share payments from Pfizer of $7 to $9 million in Q3 and $15 to $20 million for the full second half of 2024. We assume a stable foreign currency exchange rate for an X-US pharmaceutical business. In R&D expenses for the third quarter of 2024, we reflect higher activities related to our MODX program, including CMC and efforts related to our Immunilong college trials. A portion of the increased activities will continue to be funded by our BARDA agreement.

Speaker Change: As such, we expect to receive gross profit share payments from Pfizer of $7 to $9 million in Q3 and $15 to $20 million for the full second half of 2024.

Adam Logal: We assume a stable foreign currency exchange rate for our ex-U.S. pharmaceutical business, and R&D expenses for the third quarter of 2024 will reflect higher activities related to our MODEX programs, including CMC and efforts related to our immuno-oncology trial. A portion of the increased activities will continue to be funded by our BARDA agreement. For our Diagnostics segment, we anticipate the closing of the LabCorp transaction to occur by the end of September or early October, but we have included the results for the full quarter in our Outlook.

Speaker Change: We assume a stable foreign currency exchange rate for ex-U.S. pharmaceutical business.

Adam Logal: And R&D expenses for the third quarter of 2024 will reflect higher activities related to our MODEX programs, including CMC and efforts related to our immuno-oncology trials. A portion of the increased activities will continue to be funded by our BARDA agreement. For our diagnostic segment, we anticipate the closing of the LabCorp transaction to occur by the end of September or early October, but we have included the results for the full quarter in our outline.

Speaker Change: And R&D expenses for the third quarter of 2024 will reflect higher activities related to our MODEX program, including CMC and efforts related to our immuno-oncology trial.

Speaker Change: A portion of the increased activities will continue to be funded by our BARDA agreement.

Adam Logal: For our diagnostic segment, we anticipate the closing of the lab court transactions that occur by the end of September or early October, but have included the results for the full quarter in our outlook. This significant milestone allows us to rationalize our fixed cost structure and provide the foundation for Bio-Reference to return to profitability. We are continuing our multi-year, multi-phase cost reduction program, and this program is expected to include operational efficiencies in product portfolio rationalization. This program is focused on the reduction of fixed infrastructure costs and is expected to deliver annualized savings of approximately $25 million by the end of 2024, some of which we expected to begin realizing during the third quarter of 2024.

Speaker Change: For our Diagnostics segment, we anticipate the closing of the LabCorp transaction to occur by the end of September or early October , but have included the results for the full quarter in our Outlook.

Adam Logal: This significant milestone allows us to rationalize our fixed cost structure and provides the foundation for BioReference to return to profitability. We are continuing our multi-year, multi-phase cost reduction program. And this program is expected to include operational efficiencies and product portfolio rationalization. This program is focused on the reduction of fixed infrastructure costs and is expected to deliver an annualized savings of approximately $25 million by the end of 2024, some of which we expect to begin realizing during the third quarter of 2024.

Adam Logal: This significant milestone allows us to rationalize our fixed cost structure and provides the foundation for BioReference to return to profitability. We are continuing our multi-year, multi-phase cost reduction program. This program is focused on the reduction of fixed infrastructure costs and is expected to deliver an annualized savings of approximately $25 million by the end of 2024, some of which we expect to begin realizing during the third quarter of 2024.

Speaker Change: This significant milestone allows us to rationalize our fixed cost structure and provides the foundation for BioReference to return to profitability.

Speaker Change: We are continuing our multi-year, multi-phase cost reduction program.

Speaker Change: And this program is expected to include operational efficiencies and product portfolio rationalization.

Speaker Change: This program is focused...

Speaker Change: on the reduction of fixed infrastructure costs and is expected to deliver annualized savings of approximately 25 million dollars by the end of 2024, some of which we expect to begin realizing during the third quarter of 2024.

Adam Logal: The one-time cost to achieve the savings with the near-term phase of the program is expected to be approximately $40 million and primarily includes severance and facility closure costs. These costs will be recorded primarily in 2024, with cash outlies expected through 2028. In addition, we have taken action on a number of our RCM programs, including implementing a price increase during the third quarter for certain testing modalities, including our oncology offerings, which are expected to result in an overall annual increase of revenue of $8 to $10 million. Before considering any non-recurring costs that may result from our restructuring and other non-recurring expenses, we expect costs in expenses in Q3 to decline approximately $3 million to approximately $153 to $156 million, without giving effect to the approximately $33 million of costs related to the assets convened to LabCorp.

Adam Logal: The one-time costs to achieve the savings with the near-term phase of the program are expected to be approximately $40 million and primarily include severance and facility closure costs. These costs will be recorded primarily in 2024, with cash outlays expected through 2028. In addition, we have taken action on a number of our RCM programs, including implementing a price increase during the third quarter for certain testing modalities, including our oncology offerings, which are expected to result in an overall annual increase in revenue of $8 to $10 million.

Speaker Change: The one-time costs to achieve the savings with the near-term phase of the program are expected to be approximately $40 million and primarily include severance and facility closure costs.

Speaker Change: these costs will be recorded primily in two thousand and twenty four with cash outlies expected through two thousand and twenty eight

Speaker Change: In addition, we have taken action on a number of our RCM programs.

Speaker Change: including implementing a price increase during the third quarter for certain testing modalities including our oncology offerings which are expected to result in an overall annual increase of revenue of eight to ten million dollars.

Adam Logal: Before considering any non-recurring costs that may result from our restructuring and other non-recurring expenses, we expect costs in expenses in Q3 to decline approximately $3 million to approximately $153 to $156 million without giving effect to the approximately $33 million of costs related to the assets conveying to LabCorp. We expect to realize a gain net of transaction expenses of approximately $114 to $120 million related to the closing of the LabCorp agreement. As a result, we expect the following for the third quarter of 2024: total revenues between $180 and $185 million, with revenue from services between $125 and $129 million, including $24 to $25 million from the assets which will be sold to Lapid, revenue from product sales of $40 to $43 million, and other revenue between $10 and $14 million, inclusive of the Pfizer gross profit share, which is estimated to be between $7 and $9 million.

Speaker Change: Before considering any non-recurring costs that may result from our restructuring and other non-recurring expenses, we expect costs

Speaker Change: in expenses in Q3 to decline approximately $3 million to approximately $153 million to $156 million without giving

Speaker Change: to the approximately $33 million of costs related to the assets conveying to LabCorp.

Adam Logal: We expect to realize a gain net of transaction expenses of approximately $114 to $120 million related to the closing of the LabCorp agreement.

Speaker Change: We expect to realize a gain net of transaction expenses of approximately $114 to $120 million related to the closing of the LabCorp agreement.

Adam Logal: As a result, we expect the following for the third quarter of 2024. Total revenues between $180 and $185 million, with revenue from services between $125 and $129 million, including $24 to $25 million from the assets which will be sold to LabCorp. Revenue from product sales of $40 to $43 million, and other revenue between $10 and $14 million, inclusive of the Pfizer gross profit share, which is estimated to be between $79 million. We expect third quarter costs and expenses to be between $238 and $245 million, excluding the non-recurring expenses I previously mentioned. R&D expenses expected to increase to be between $24 and $28 million, with the range to be dependent on certain CMTC activities for our ModEx programs. And we expect appreciation and amortization expense to be approximately $24 million.

Adam Logal: We expect third-quarter costs and expenses to be between $238 and $245 million, excluding the non-recurring expenses I previously mentioned. R&D expense is expected to increase to be between $24 and $28 million, with the range being dependent on certain CMTC activities for our MODX group. And we expect depreciation and amortization expense to be approximately $24 million.

Speaker Change: As a result, we expect the following for the third quarter of 2024.

Adam Logal: Total revenues between $180 and $185 million, with revenue from services between $125 and $129 million, including $24 to $25 million from the assets which will be sold to LAPD, revenue from product sales of $40 to $43 million, and other revenue between $10 and $14 million, inclusive of the Pfizer gross profit share, which is estimated to be between $7 and $9 million. We expect third-quarter costs and expenses to be between $238 and $245 million, excluding the non-recurring expenses I previously mentioned.

Speaker Change: Total revenues between $180 and $185 million, with revenue from services between $125 and $129 million, including $24 to $25 million from the assets which will be sold to LabCorp.

Speaker Change: Revenue from product sales of $40 to $43 million, and other revenue between $10 and $14 million, inclusive of the Pfizer gross profit share, which is estimated to be between $7 and $9 million.

Speaker Change: We expect third quarter costs and expenses to be between $238 and $245 million, excluding the non-recurring expenses I previously mentioned.

Adam Logal: R&D expense is expected to increase to be between $24 and $28 billion, with the range being dependent on certain CMTC activities for our MODX program. And we expect depreciation and amortization expense to be approximately $24 million.

Speaker Change: R&D expense is expected to increase to be between $24 and $28 billion, with the range being dependent on certain CMTC activities for our MODEX programs.

Speaker Change: And we expect depreciation and amortization expense to be approximately $24 million.

Adam Logal: This concludes our preparatory remarks.

Operator: This concludes our preliminary remarks. Thank you all for your attention. And now, operator, let's open the call for Thank you. We will now begin our

Operator: Thank you all for your attention, and now, operator, please open the call for questions.

Speaker Change: This concludes our prepared remarks. Thank you all for your attention and now operator, let's open the call for questions.

Operator: Thank you. We will now begin our question and answer session. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. And the first question will be from Maurice Raycroft from Jeffreys. Please go ahead.

Operator: Thank you.

Operator: We will now begin our question and answer session. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster.

Speaker Change: Thank you. We will now begin our question and answer session. To ask a question, you may press star then 1 on your telephone keypad. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster.

Marie Raycroft: And the first question will be from Marie Raycroft from Jeffries. Please go ahead. Hi, thanks for taking my questions, and congrats on the progress for the quarter. Maybe first one just on in general. So it seems like the guidance for a second half of this year is narrowing and lowering a little bit. Just checking if anything changed commercially since last quarter, or is this related to just getting experience with the gross profit share economics? Or is it due to inventory or anything else commercially that Pfizer could be seeing? Yeah, no, this is tied into the inventory adjustment that we talked about last quarter.

Speaker Change: and the first question will be from mai raycroft from jeffreys please go ahead

Maurice Raycroft: Hi, thanks for taking my questions and congrats on the progress for the quarter. Maybe the first one just on IngenLA, so it seems like the guidance for the second half of this year is narrowing and lowering a little bit. Just checking if anything changed commercially since last quarter, or is this related to just getting experience with the gross profit share economics, or is it due to inventory or anything else commercially that Pfizer is doing.

Maurice Raycroft: Hi, thanks for taking my questions, and congrats on the progress for the quarter. Maybe the first one just on IngenLaw. So it seems like the guidance for the second half of this year is narrowing and lowering a little bit. Just checking if anything changed commercially since last quarter, or is this related to just getting experience with the gross profit share economics, or is it due to inventory or anything else commercially that Pfizer can do?

mai raycroft: Hi, thanks for taking my questions and congrats on the progress for the quarter.

Speaker Change: Thank you.

mai raycroft: Maybe first one just on Engenla. So it seems like the guidance for second half of this year is narrowing and lowering a little bit. Just checking if anything changed commercially since last quarter, or is this related to just getting experience with the gross profit share economics, or is it due to inventory or anything else commercially that Pfizer could be seeing?

Unnamed Speaker: Yeah, no, this is tied into the inventory adjustment that we talked about last quarter, Maurice, so it's just the final pull-through of certain territories, that adjustment getting flushed out. We had hoped it would be earlier in the third quarter, but it looks like it's going to be late in the third quarter based on our internal factors, so that's why the annual range came down to kind of the mid-30s from potentially size 40.

Adam Logal: Yeah, no, this is tied into the inventory adjustment that we talked about last quarter, Maurice, so it's just the final pull through of certain territories, that adjustment getting flushed out. We had hoped it would be earlier in the third quarter, but it looks like it's going to be late in the third quarter based on our internal factors, so that's why the annual range came down to kind of the mid-30s from potentially size 40.

Speaker Change: Yeah, no, this is this is tied into the the inventory adjustment that we talked about last quarter, Maurice, so it's just the the final pull through of

Marie Raycroft: So it's just the final toll through of certain territories, that adjustment getting flushed out. We had hoped it would be earlier in the third quarter. It looks like it's going to be late third quarter based on our internal factors. That's why the annual range came down to kind of the mid thirties from potentially size 40. Got it.

Speaker Change: of certain territories, that adjustment getting flushed out. We had hoped it would be earlier in the third quarter. It looks like it's going to be late third quarter based on our internal factors, so that's why the annual range came down to kind of the mid-30s from potentially size 40.

Adam Logal: Got it, okay, that's helpful, and then I'm Is it... Is it possible to bookend timing for when Pfizer could aim to refile for the adult growth hormone opportunity? And is there more you can say on the status and plan for the additional pediatric indication?

Unnamed Speaker: Got it, okay, that's helpful, and then um, Is it... Is it possible to bookend timing for when Pfizer could aim to refile for the adult growth hormone opportunity, and is there more you can say on the status and plan for the additional pediatric indication?

Marie Raycroft: Okay, that's helpful.

Marie Raycroft: And then, is it possible to book a timing for when Pfizer could aim to refile for the adults' growth hormone opportunity? And is there more you can send the status and plan for the additional pediatric indications? So on the pediatric indications, Pfizer is planning their registration studies to bring those forward for the global launch for those additional indications that we haven't provided any specific timelines for those trials to be completed yet. I think more to come; they're definitely actively working on the programs. As it relates to the US, the US for the adult, they're still working with their team to formulate their strategy for the US approval.

Speaker Change: got it okay that's helpful and then um is it

Speaker Change: Is it possible to bookend timing for when Pfizer could aim to refile for the adult growth hormone opportunity and is there more you can say on the status and plan for the additional pediatric indications?

Adam Logal: So on the pediatric indications, Pfizer is planning their registration studies to bring those forward for the global launch for those additional indications. We haven't provided any specific timelines for those trials to be completed yet, Maury, but I think more to come. They're definitely actively working on the programs. As it relates to the U.S. for the adult indication, they're still working with their team to formulate their strategy for U.S. approval

Unnamed Speaker: So on the pediatric indications, Pfizer is planning their registration studies to bring those forward for the global launch for those additional indications. We haven't provided any specific timelines for those trials to be completed yet, Maury, but I think more to come. They're definitely actively working on the programs. As it relates to the U.S. for the adult indication, they're still working with their team to formulate their strategy for U.S. approval

Speaker Change: So on the pediatric indications, so Pfizer is planning their registration studies.

Speaker Change: to bring those forward for the global launch for those additional indications. We haven't provided any specific timelines for those trials to be completed yet, Maury, but...

Speaker Change: i think more to come they're definitely actively working up on the programs as it relates to the u s the the u s for the adult they're still working with their with their team to formulate their strategy for the u us approval

Marie Raycroft: Understood.

Adam Logal: And then last question, I'll hop back in the queue. Just for the deal closing with BioReference, thanks for providing the clarity into when you expect that to happen. Is there anything else you can share about where you're at with the process, and what are specific gating factors for the closing?

Unnamed Speaker: Okay, and then last question, I'll hop back in the queue. Just for the deal closing with BioReference, thanks for providing the clarity into when you expect that to happen. Is there anything else you can share about where you're at with the process, and what are specific gating factors for the closing?

Marie Raycroft: Okay, and then last question. I'll hop back in the queue just for the deal closing with bio reference. Thanks for providing the clarity into when you expect that to happen. Is there anything else you can share about where you're at with the process and what are specificating factors to the closing? Yeah, so right now it's really, you know, focused heavily on the integration steps between the clients and in LabCorp. So those are the main gating items. There's a couple of minor regulatory filings that just need to get cleared up at all. All of the major hurdles are behind us, which is why we have pretty certain clarity, but this transactional get closed late September or early October.

Speaker Change: Understood. Okay, and then last question, I'll hop back in the queue. Just for the the deal closing with BioReference, thanks for providing the clarity into when you expect that to happen. Is there anything else you can share about where you're at with the process and what are specific gating factors to the closing?

Unnamed Speaker: Yeah, so we're really, you know, focused heavily on the integration steps between the clients and LabCorp. So those are the main gating items there. There's a couple of minor regulatory filings that just need to get cleared up at all. All of the major hurdles are behind us, which is why we have pretty, pretty certain clarity about the transaction will get closed in late September or early October.

Adam Logal: Yeah, so right now, we're really, you know, focused heavily on the integration steps between the clients and LabCorp. So those are the main gating items there. There are a couple of minor regulatory filings that just need to get cleared up at all. All of the major hurdles are behind us, which is why we have pretty, pretty certain clarity about the closing of this transaction in late September or early October.

Speaker Change: Yeah, so right now it's really, you know...

Speaker Change: focused heavily on the integration steps between between the clients and lap corp so those of the main gating items there's a couple of minor regulatory filings that just need to get

Speaker Change: All of the major hurdles are behind us, which is why we have pretty certain clarity that this transaction will get closed late September or early October .

Maurice Raycroft: Got it. Okay, thanks for taking my questions.

Marie Raycroft: Got it. Okay, thanks for taking my questions.

Yale Jen: And the next question will be from Yale, Jen, from Lead Law and Company. Please go ahead. Good afternoon, and thanks for taking the questions. My first one is that in terms of closing the lip cord deals, and you mentioned some of the savings, should that all be real-life? Could you give us some sort of quantitative look in terms of how far from that to Raycroft even and the cash break even, and did we have a follow-up? Yes, so, yeah, I think if you step through the numbers and the cost savings plan and the realization of the price increases coupled with the closing of the lab court transaction, that'll put us to a point where the business is breaking even the slightly profitable.

Operator: And the next question will be from...

Speaker Change: Got it. Okay, thanks for taking my questions.

Speaker Change: And the next question will be from Yale Jen from Laidlaw and Company. Please go ahead.

Unnamed Analyst: Well, good afternoon, and thanks for taking the questions. The first one is that in terms of closing the record deals, and you mentioned some of the savings. Should that all be realized, could you give us some sort of quantitative look in terms of how far from that it would take to breakeven and then reach breakeven, and then we have a follow-up?

Unnamed Speaker: Good afternoon and thanks for taking the questions. The first one is that, in terms of closing record deals, and you mentioned some of the savings, could you give us some sort of quantitative look in terms of how far from that it would take to breakeven and then reach breakeven, and then we have a follow-up?

Yale Jen: Well good afternoon and thanks for taking the questions. My first one is that in terms of closing the...

Le Cordeaux: Le Cordeaux, and you mentioned some of the savings.

Yale Jen: Should that all be realized, could you give us some sort of quantitative look in terms of how far from that to breakeven and catch breakeven and then we have a follow-up?

Unnamed Speaker: So, Yael, I think if you step through the numbers and the cost savings plan and the realization of the price increases coupled with the closing of the LabCorp transaction, that'll put us to a point where the business is break-even to slightly profitable. So we only gave the initiatives that we expect or we have in hand that will initiate upon the closing of the LabCorp transaction. A handful of those are not dependent on the LabCorp transaction closing.

Adam Logal: So, Yael, I think if you step through the numbers and the cost savings plan and the realization of the price increases coupled with the closing of the LabCorp transaction, that'll put us to a point where the business is break-even to slightly profitable. So we only gave the initiatives that we expect or we have in hand that will initiate upon the closing of the LabCorp transaction. A handful of those are not dependent on the LabCorp transaction closing.

Yale Jen: Yes, so Yael, I think if you you step through the numbers and the cost savings plan and the realization of the price increases

Yale Jen: coupled with the closing of the LabCorp transaction.

Yale Jen: You know, that'll put us to a point where the business is...

Yale Jen: So, we only gave the initiative that we expect or we have in hand that we will initiate upon the closing of the lab court transaction. The handful of those are not dependent on the lab court transaction closing. Some of the larger ones are as it relates to some of the facility closures. However, we feel highly confident in our ability to deliver the savings that we walk through, and the price increases have already been put into effect. So, we feel very confident on those numbers being realized in our run rate numbers by the end of the year, which is where we had previously guided to.

Yale Jen: is breakeven to slightly profitable.

Speaker Change: So we only gave the initiatives that we expect or we have in hand.

Speaker Change: that we've, that will initiate upon the closing of the LabCorp transaction. A handful of those are not dependent on the LabCorp transaction closing. Some of the larger ones are as it relates to some of the facility closures.

Adam Logal: Some of the larger ones are as it relates to some of the facility closures. However, we feel highly confident in our ability to deliver the savings that we walked through and the price increases have already been, you know, put into effect. So we feel very confident in those numbers being realized and our run rate numbers by the end of the year, which is where we had previously guided.

Unnamed Speaker: Some of the larger ones are as it relates to some of the facility closures. However, we feel highly confident in our ability to deliver the savings that we walked through, and the price increases have already been put into effect. So we feel very confident in those numbers being realized, and our run rate numbers by the end of the year, which is where we had previously guided.

Yale Jen: However, we feel highly confident in our ability to deliver the savings that we need.

Yale Jen: that we walked through and the price increases have already been put into effect. So we feel very confident on those numbers being realized and our run rate numbers by the end of the year, which is where we had previously guided to.

Yale Jen: Okay, great. That's very helpful.

Unnamed Analyst: Okay, great. That's very helpful, and congrats on that. And just one more question on MDX-2001, which is first, have you guys reviewed what the specific target for the type of peptide was the antibody against? And the second one actually is on the size of the study, which you mentioned about 45 patients. Is that just only the phase 1A, 1B, or that's more... I understand the full study also has the 2A portion, the phase 2A portion. So would you be able to clarify a little bit more on this specific? And thanks. Yeah,

Unnamed Speaker: Okay, great, that's very helpful, and congrats on that. And just one more question on MDX-2001, which is, first, have you guys reviewed what the specific target for the tetrapeptide was on the antibody against? And the second one actually is on the Pfizer study, which you mentioned about 45 patients. Is that just only the phase 1A, 1B, or that's more? I understand the full study also has the 2A portion, phase 2A portion, so would you be able to clarify a little bit more on the specifics? Thanks. Yes, yes, I can do that, Elias, yeah.

Yale Jen: I have a question on the MDX-2001. Have you guys reviewed what the specific target for the type of factor and the body was against? And the second one actually is on the size of study, which you mentioned, about 45 patients. Is that just only the base 1A1P, or that's more? I understand, a full study also has the 2A portion, space 2A portion. So, do you be able to clarify a little bit more on this, and thanks. Yes, I can do that. Thank you for the question. On the target, I think it's something we have now shared, so I think it's no problem sharing it with you.

Yale Jen: Okay, great. That's very helpful and congrats on that. And just one more question on the MDX-2000.

Speaker Change: to 001, which is the first part. Have you guys reviewed what the specific target for the clinical factor was anybody was against? And the second one actually is on these.

Speaker Change: The Pfizer study which you mentioned about 45 patients, is that just only the phase 1A, 1B, or that's more... I understand the full study also has the 2A...

Elias: Portion, Phase 2a Portion, so, you'll be able to clarify a little bit more on the specifics, and thanks. Yes, yes, I can do that, Elias, yeah. Thanks for the question, Neil. On the target, I think it's something we have now shared, so I think it's no problem sharing it with you.

Elias Zerhouni: Yes, yes, I can do that. Elias, yeah.

Elias Zerhouni: Thanks for the question, you know. On the target, I think it's something we have now shared, so I think it's no problem sharing it with you. It's a quadri-specific antibody that has two targets for tumor targeting. One is TROP2, and the other one is CMAP. These are the two targets we chose because they're present on about 14 different tumors in alcohol. So that's the answer to that.

Elias Zerhouni: Thanks for the question, Neil. On the target, I think it's something we have now shared, so I think it's no problem sharing it with you. It's a, so it's a quadri-specific antibody that has two targets for tumor targeting. One is TROP2, and the other one is CMAP. These are the two targets we chose because they're present in about 14 different tumors in alcohol. So that's the answer to that. The size of the study really reflects what you typically do.

Yale Jen: So, it's a quadru-specific antibody that has four tumor targeting, has two targets. One is 122, and the other one is. These are the two targets we chose because they're present on about 14 different tumors in oncology. So, that's the answer to that. The size of the study really reflects what you technically do, is what we do; we call it a basket trial, where you really try different tumor types. We have 11 ones identified, and you try to get signals about the most promising one, which we believe is going to be not supposed to sell on cancer, but it's cancer, the solid tumors, pancreatic cancer, we don't know.

Speaker Change: It's a, so it's a quadrispecific antibody.

Yale Jen: that has, for tumor targeting, has two targets. One is THROP2.

Elias: and the other one is CMAT. These are the two targets we chose because they're present on about 14 different tumors in

Elias Zerhouni: The size of the study really reflects what you typically do. It's what we do, we call it a basket trial, where you really try different tumor types. We have 11 ones identified. And you try to get signals about the most promising ones, which we believe are gonna be non-small cell lung cancer, breast cancer, solid tumors, pancreatic cancer. We don't know.

Speaker Change: at Oncology.

Speaker Change: so that's the answer to the sizeof study really would

Elias Zerhouni: It's what we do; we call it a basket trial, where you really try different tumor types. We have 11 ones identified. And you try to get signals about the most promising ones, which we believe are gonna be non-small cell lung cancer, breast cancer, solid tumors, pancreatic cancer. But we don't know.

Elias: reflects what you typically do.

Speaker Change: It's what we do, we call it a basket trial.

Speaker Change: where you really try different tumor types. We have 11 ones identified, and you try to get signals about the most promising one, which we...

Elias: believe there's going to be an osmosis of lung cancer, breast cancer, the solid tumors, pancreatic cancer. We don't know.

Yale Jen: So, that's the first phase of the study; that's what you call the 1A phase. Once we do that, then we'll narrow down to one or maybe two tumor types, which is contained within the patient volume that we identify for the patient number, and then we'll expend that, depending on the results, obviously, the cytosyxin. So, that's clinical development; we need to learn from the basket trial and then decide how we go. And yes, indeed, we have a 1A or 1B phase, or go straight to a 2A; that's to be the term. by the plan. Great.

Elias Zerhouni: So that's the first phase of the study. That's what you call the 1A phase. Once we do that, then we'll narrow down to one or maybe two tumor types, which are contained within the patient volume that we identified for the patient number. And then we'll expand that, depending on the results, obviously, the side effects. So that's clinical development. We need to learn from the basket trial and then decide how we go.

Elias Zerhouni: So that's the first phase of the study. That's what you call the 1A phase. Once we do that, then we'll narrow down to one or maybe two tumor types, which is contained within the patient volume that we identified for the patient number. And then we'll expand that, depending on the results, obviously, and the side effects. And so that's, you know, clinical development. We need to learn from the basket trial and then decide how we go. And yes, indeed, we have a 1A or a 1B phase or go straight to 2A. That's to be determined. Okay, great.

Yale Jen: So that's the first phase of the study. That's what you call the 1A phase. Once we do that, then we'll narrow down to one or maybe two tumor types, which is contained within the

Yale Jen: patient volume that we have.

Speaker Change: What is the latest from Martin and Eric Vagner?

Speaker Change: So that's, you know, clinical development. We need to learn from the basket trial and then decide how we go. And yes, indeed, we have a 1A or a 1B phase or go straight to a 2A. That's to be determined.

Elias Zerhouni: And yes, indeed, we have a 1A or a 1B phase, or we go straight to a 2A. That's to be determined. Okay, great. And maybe just tap one more here, which is, was there any... A timeline we can start to get some, top line or initial readout.

Unnamed Analyst: And maybe just tap one more here, which is, was there any... A timeline we can start to get them, top line or initial readout.

Yale Jen: And maybe just tap one more here, which is, was there any timeline we can start to get some top line or initial readouts? Okay, so typically when you do an immuno-oncology trial, you have a first phase, which is safety. So we are isolating the dose. We hope that this will take about six months if everything goes well. And then we'll go into a more efficacy type trial with a cohort of patients, about three patients per dose, ascending dose. So it's hard to predict, really, because you can't really tell how many patients are going to show up at what time in the six sites.

Speaker Change: by the clounking greay

Speaker Change: And maybe just tap one more here, which is, was there any timeline we can start to get some...

Speaker Change: top line or initial readout.

Elias Zerhouni: Okay, so typically when you do an immuno-oncology trial, you have a first phase, which is safety. So we are insulating the dose.

Elias Zerhouni: Okay, so typically when you do an immuno-oncology trial, you have a first phase, which is safety. So we are limiting the dose.

Speaker Change: Okay, so typically when you do an immuno-oncology trial, you have a first phase, which is safety. So we are isolating the dose.

Elias Zerhouni: We hope that this will take about six months, if everything goes well. And then we'll go into a more efficacy-type trial with a cohort of patients, about three patients per dose, ascending dose. So it's hard to predict, really, because you can't really tell how many patients are gonna show up at what time at the six sites. We have two sites right now, and we have four more.

Speaker Change: We hope that this will take about six months.

Speaker Change: if everything goes well. And then we'll go into a more efficacy type trial with a cohort of patients, about three patients per dose, ascending dose. So.

Speaker Change: It's hard to predict, really, because you...

Speaker Change: You can't really tell how many patients are gonna show up at what time in the six sites. We have two sites right now.

Yale Jen: We have two sites right now, and we have four more. Two are imminently going to get activated, and two more after that. And so it's really hard to tell, but I think that by 2025, first quarter, we will know if we have a drug that is safe and that can be increasingly dose. Okay. So that's step one. And we don't know that at this time. You know, immunocology is always a, they're very powerful therapies, but they also have side effects we need to understand and manage. So that's what will you get a readout as to the viability of the program is probably the first half of it's 25.

Elias Zerhouni: Two are imminently going to be activated, and two more after that. And so it's really hard to tell, but I think that by 2025, the first quarter, we will know if we have a drug that is safe and that can be increasingly dosed, okay? So that's step one, and we don't know that at this time. Immuno-oncology is always a very powerful therapy, but they also have side effects we need to understand and manage.

Speaker Change: and we have four more two imminently going to get activated and two more upafter to that and so it's really haunted but i think that by twenty and twenty five first quarter we will know if we have a drug that is sa

Speaker Change: and that can be increasingly dosed, okay? So that's step one. And we don't know that at this time. You know, immuno-oncology is always a, they're very powerful therapies, but they also have side effects we need to understand and manage.

Elias Zerhouni: So that's where you would get a readout as to the viability of the program. It's probably the first half of 25, and then we will know what targets to go after within 2025, depending on the results.

Speaker Change: so that's what where you would get a readoutbts as to the viability of the program is probably the first have to twenty-five and then we will know what targets to go after within move in twent twenty five depending on results

Yale Jen: And then we will know what targets to go after within 2020, so I have to finish on the results. Okay, great. That's very helpful.

Unnamed Analyst: Okay, great. That's very, very helpful and, again, aggressive on the product.

Unnamed Speaker: Okay, great. That's very, very helpful and, again, aggressive on the product.

Speaker Change: Okay, great. That's very, very helpful, and again, congrats on all the projects.

Operator: And the next question will be from Michael Petusky from Barrington Research. Please go ahead. Good afternoon, guys.

Michael Petusky: And the next question will be from Michael Petusky from Barrington Research. Please go ahead. Good afternoon, guys.

Michael Petusky: And again, Patusky from Barrington Research, please go ahead. Yeah, good afternoon, guys. So I guess the first first question, you know, at the end of this year, you know, it seems like a lot of things are sort of converging, you know, sort of going in the right direction. You know, presumably you have approximately 240, just under 240 million coming in from the lab core. Obviously, you just did something a couple of weeks ago that gives you additional financial flexibility in terms of the 250 million. You'll have a lab business that presumably by the end of the year won't be losing much money, if losing money at all.

Speaker Change: Thank you.

Speaker Change: And the next question will be from Michael Petusky from Barrington Research. Please go ahead.

Michael Petusky: Good afternoon guys. So I guess the first question is, you know, at the end of this year, you know, it seems like a lot of things are sort of converging, you know, sort of going in the right direction, you know, presumably you'll have approximately 240, just under $240 million coming in from LabCorp. Obviously, you just did something a couple weeks ago that gives you additional financial flexibility in terms of the $250 million.

Michael Petusky: Good afternoon guys. So I guess the first question, you know,

Michael Petusky: At the end of this year, you know, it seems like a lot of things are sort of converging, you know, sort of going in the right direction. You know, presumably you'll have approximately 240, just under 240 million coming in from the LabCorp.

Speaker Change: Obviously, you just did something a couple weeks ago that gives you additional financial flexibility. In terms of the $250 million, you'll have a lab business that presumably by the end of the year won't be losing much money, if losing money at all.

Michael Petusky: You'll have a lab business that, presumably, by the end of the year won't be losing much money, if any at all. Can you just talk about capital allocation priorities as you sort of end this year and look toward the future? I mean, what matters the most as far as the, you know, the sort of unprecedented financial flexibility you guys will have going forward? Thanks.

Michael Petusky: Can you just talk about capital allocation priorities as you sort of end this year and look towards the future? I mean, what matters the most as far as the, you know, the sort of unprecedented financial flexibility you guys will have going forward. Thanks.

Speaker Change: Can you just talk about capital allocation priorities as you sort of end this year and look look towards the future? I mean what...

Speaker Change: What matters the most as far as the, you know, the sort of unprecedented financial flexibility you guys will have going forward? Thanks.

Michael Petusky: Alex, you want to kick us off, and I can fill in? I'll talk about capital allocation in terms of, you know, R&D and, and, um, minor reference. So when we look at, um, a bio reference, it's clear that we will need to grow the business once it's becomes profitable. And whether or not we need to allocate capital to that is unclear. But it's clearly true that if you look at the market in New York and New Jersey, it's still very fragmented. And so it definitely can be accelerated to growth in bio reference for increasing revenues.

Elias Zerhouni: Elias, do you want to kick us off and I can fill in? I'll talk about it.

Elias Zerhouni: Elias, do you want to kick us off and I can fill in? I'll talk about that in a minute.

Speaker Change: what

Elias Zerhouni: I'll talk about capital allocation in terms of, you know, R&D and bio-referencing. So, when we look at bio-referencing, it's clear that we will need to grow the business once it becomes profitable. And whether or not we need to allocate capital to that is unclear. But it's clearly true that if you look at the market in New York and New Jersey, it's still very fragmented. And so, definitely accelerate the growth in bio-reference for increasing revenues. The second is MODEX.

Speaker Change: Elias, you want to kick us off and I can fill in?

Elias: I'll talk about capital allocation in terms of R&D and bio-reference. So, when we look at bio-reference, it's clear that we will need to grow the business once it becomes profitable.

Elias: profitable and whether or not we need to allocate cappeital to that is unclear it's clearly true that if you look at the market in new york and users is silververy fragmented

Speaker Change: And so...

Speaker Change: definitely accelerate the growth in bioreference for increasing revenues.

Elias Zerhouni: I mean, MODEX has a rich portfolio, and we're going to do two things. We're going to explore partnerships, as we have done, you know, with Merck and BARDA and others that are in the pipeline. But because we have some capital, we can get better economics at www.opkohealth.com. So it's going to be, you know, depending upon results, obviously, depending upon partnerships, because we think that we're not going to take the risk. I believe, unless we have exceptional results, of allocating the capital to completely carry the development program all the way to approval.

Elias Zerhouni: I mean, MODEX has a rich portfolio, and we're going to do two things. We're going to explore partnerships, as we have done, you know, with Merck and BARDA and others that are in the pipeline. But because we have some capital, we can get better economics at www.opkohealth.com. So it's gonna be, you know, depending upon results, obviously, depending upon partnerships, because we think that we're not going to take the risk. I believe, unless we have exceptional results, of allocating the capital to completely carry the development program all the way to approval.

Michael Petusky: The second is Modex. Modex has a rich portfolio. And we're going to do two things. We're going to explore partnerships as we've done, you know, with Merck and Butter, and others are in the hopper. But because we have some capital, we can get better economics with a partner than we do with that capital being available. So, for example, if you look at certain assets, you get a much higher inflection point in value if you can progress the program to proof of concept. And that may be actually the best way to achieve greater economics for the portfolio.

Speaker Change: the second of is mox i mean mox has a rich portfolio

Speaker Change: And we're going to do two things. We're going to explore partnerships, as we've done, you know, with Merck and Barda and others that are in the hopper. But because we have some capital, we can get better economics.

Speaker Change: We're the partners and we do the vast capital being available.

Speaker Change: So, for example, if you look at certain assets, you get a much...

Speaker Change: Higher inflection points in value if you can progress the program to proof of concept and And that may be actually the best way to to achieve greater economics for the portfolio

Michael Petusky: So it's going to be, you know, depending upon results, obviously, depending upon partnerships because we think that we, we're not going to take the risk, I believe, unless we have like exceptional results of allocating the capital to completely carry the development program all the way to approval. I don't think we have enough of that, and it will not be hedging, and it'll be reasonable to do that unless you have outstanding, you know, exceptional results. But the best path forward right now is to really try to get a bigger share of the economics of our portfolio by very judicious and very limited capital education.

Speaker Change: So, it's going to be, you know, depending upon results, obviously, depending upon partnerships, because we think that we're not going to take the risk.

Speaker Change: I believe, unless we have exceptional results, of allocating the capital to completely carry the development program all the way to approval.

Elias Zerhouni: I don't think we have enough of that, and it would not be hedging; it would not be reasonable to do that unless you have outstanding, exceptional results. But the best path forward right now is to really try to get a bigger share of the economics of our portfolio through very judicious and very limited capital allocation; you're not talking about hundreds of millions of dollars. But if you can advance a program to a POC, you know, a feasibility stage, then it really increases in value for potential strategic partners or other movements. I don't know if I'm making myself clear. Now, in terms of the other users of capital, I'll let Adam comment on that.

Elias Zerhouni: I don't think we have enough of that, and it will not be hedging, and it would not be reasonable to do that unless you have outstanding, exceptional results. But the best path forward right now is to really try to get a bigger share of the economics of our portfolio through very judicious and very limited capital allocation. You're not talking about hundreds of millions of dollars, but if you can advance a program to a POC, a feasibility stage, then it really increases in value for potential strategic partners or other movements. I don't know if I'm making myself clear. Now, in terms of the other users of capital, I'll let Adam comment on that.

Speaker Change: I don't think we have enough.

Speaker Change: of that, and it will not be hedging, it will not be reasonable to do that unless you have outstanding, you know, exceptional results. But the best path forward right now is to really try to get a bigger share of the economics

Speaker Change: in very detailed work.

Michael Petusky: You're not talking about hundreds of dollars. But if you can advance a program to the POC's, you know, a feasibility stage, then it really increases in value for potential strategic partners or other moves. Oops, I don't know if I'm making myself there.

Speaker Change: you know, a feasibility stage, then it really increases in value for potential strategic partners or other moves.

Michael Petusky: Now, in terms of the other uses of capital, I'll let Adam comment on that. Yeah, so Mike, I think the other component, we announced a $100 million stock share buyback. I think we've talked a little bit about potentially taking out portions of the convertible notes that are outstanding as well. But I think we're going to be allocating that capital based on the market conditions for both of those items. We'll provide longer-term guidance as it relates to the R&D budget and other items in upcoming calls. But we're sitting here today working through all of those different polls and pushes on creating that shareholder value and are committing significant dollars already to returning capital to shareholders through those two repurchase programs. Adam, if I could ask, is there any sort of targeted time frame on sort of achieving or executing most of the sharey purchase or whatever notes you might decide to repurchase?

Speaker Change: i don't know if i'm making myself there now in terms of the other uses of capital i'll let ad am comment on that

Adam Logal: Yeah, so Mike, I think the other components, you know, we announced a $100 million dollar share buyback. I think we've talked a little bit about potentially taking out, you know, portions of the convertible notes that are outstanding as well. But I think we're going to be, you know, allocating that capital based on the market conditions for both of those items. We'll provide longer-term guidance as it relates to the R&D budget and other items in upcoming calls, but we're sitting here today working through all of those different pulls and pushes on creating that shareholder value and are committing significant dollars already to returning capital to shareholders through those two repurchase programs.

Adam Logal: So, Mike, I think the other components, you know, we announced a $100 million share buyback. I think we've talked a little bit about potentially taking out, you know, portions of the convertible notes that are outstanding as well, but I think we're going to be, you know,

Mike: Allocating that capital based on the market conditions for both of those items.

Speaker Change: We'll provide longer-term guidance as it relates to the R&D budget and other items in upcoming calls, but we're sitting here today.

Adam Logal: But, you know, we're sitting here today working through all of those different pulls and pushes on creating that shareholder value and are committing significant dollars already to returning capital to shareholders through those two repurchase programs.

Speaker Change: working through.

Speaker Change: all of those different pulls and pushes on creating that shareholder value and are committing significant dollars already to returning capital to shareholders through those two repurchase programs.

Michael Petusky: Adam, if I could ask, is there any sort of targeted timeframe for, you know, sort of achieving or executing most of the share repurchase or, you know, in whatever notes you might decide to repurchase?

Speaker Change: Adam, if I could ask, is there any sort of targeted timeframe on, you know, sort of achieving or executing most of the share repurchase or whatever notes you might decide to repurchase?

Adam Logal: So we haven't set a timetable for it yet.

Adam Logal: So we haven't set a timetable for it, by the way.

Michael Petusky: So we haven't set a timetable to it myself.

Adam Logal: So we haven't set a timetable to it right now.

Michael Petusky: Okay, and then I guess on Ray Aldi, you guys have been maybe for the last few quarters sort of suggesting, hey, we think we've got some data that could be interesting to a nephrologist in terms of the efficacy for these CKD patients. It hasn't really shown up in the numbers. I think we're about a flat year over year for the first half versus the first half of 23. I mean, is there anything anecdotal that you're getting back from sales in terms of data that you guys are trying to argue, hey, this should matter to you guys?

Michael Petusky: And then, I guess, on Rialdi, you guys have been, you know, maybe for the last few quarters sort of suggesting, hey, we think we've got some data that could be interesting to nephrologists, you know, in terms of the efficacy for these CKD patients, but it hasn't really shown up in the numbers. I think we're about flat year over year for the first half versus the first half of 2023.

Michael Petusky: And then, I guess, on Rayaldi, you guys have been, you know, maybe for the last few quarters sort of suggesting, hey, we think we've got some data that could be interesting to nephrologists, you know, in terms of the efficacy for these CKD patients, but it hasn't really shown up in the numbers. I think we're about flat year-over-year for the first half Is there anything anecdotal that you're getting back from sales in terms of this, you know, data that you guys are trying to argue, hey, this should matter to you guys? I mean, is there anything to say about that that would be encouraging, or does it just, you know, this missionary, it takes a while?

Speaker Change: And then, I guess, you know, on Rialdi, you guys have been, you know, maybe for the last few quarters sort of suggesting, hey, you know, we think we've got some data that could be interesting to nephrologists, you know, in terms of the efficacy for these CKD patients.

Speaker Change: hasn't really shown up in the numbers. I think we're about flat year-over-year for the first, you know, first half versus the first half of 23. I mean...

Michael Petusky: Is there anything anecdotal that you're getting back from sales in terms of this, you know, data that you guys are trying to argue, hey, this should matter to you guys? I mean, is there anything to say about that that would be encouraging, or does it just, you know, as a missionary, take a while?

Speaker Change: Is there anything anecdotal that you're getting back from sales in terms of this, you know, data that you guys are trying to argue, hey, this should matter to you guys? I mean, is there anything to say on that that would be encouraging or just, you know, this missionary, it takes a while? Thanks.

Michael Petusky: I mean, is there anything to say on that that would be encouraging, or does this missionary and it takes a while? Thanks.

Michael Petusky: I don't know if Charlie is online, Dr. Bishop. He's not. Okay, so let me take it. So, you know, when you look at the issue of growth for Ray Aldi, the number one request from nephrologist is, does it have a good outcome impact? And that's defined as delaying dialysis and delaying the onset of, you know, total renal failure. Now, one of the factors that drives that is when your hypothyroid is producing a large amount of hormone because the kidney itself is no longer producing vitamin D. And the only drug that really has been shown to raise to the, to be able to raise the levels of vitamin D to the levels where the predatory hormone goes down is Ray Aldi.

Unnamed Speaker: I don't know if Charlie is online, Dr. Bishop. He's not.

Elias Zerhouni: I don't know if Charlie is online, Dr. Bishop. He's not.

Speaker Change: I don't know if Charlie is online, Dr. Bishop. He's not. Okay, so let me take it. So, you know, when you look at the

Unnamed Speaker: Okay, so let me take it. So, you know, when you look at the... The issue of growth morality, the number one request from nephrologists is, does it have a good outcome? And that's defined as delaying dialysis and delaying the onset of total renal failure. Now, one of the factors that drive that is when your hyperparathyroid is producing a large amount of hormones because the kidney itself is no longer producing vitamin D. And the only drug that really has been shown to be able to raise the levels of vitamin D to the levels where the parathyroid hormone goes down is Royalde.

Elias Zerhouni: Okay, so let me take it. So, you know, when you look at the... The issue of growth morality, the number one request from nephrologists is, does it have a good outcome? And that's defined as delaying dialysis and delaying the onset of total renal failure. Now, one of the factors that drive that is when your hyperparathyroid is producing a large amount of hormones because the kidney itself is no longer producing vitamin D. And the only drug that really has been shown to be able to raise the levels of vitamin D to the levels where the parathyroid hormone goes down is Royaldi.

Speaker Change: The issue of growth for OLD, the number one request from nephrologists is, does it have a good outcome impact?

Speaker Change: And that's defined as delaying dialysis and delaying the onset of total renal failure.

Speaker Change: Now one of the factors that drives that is when your hyperthyroid is producing a large amount of hormones.

Speaker Change: because the kidney itself is no longer producing viram indeed

Speaker Change: And the only drug that really has been shown to raise to the...

Elias Zerhouni: We've shown that before, so it's not new. However, what we haven't shown, and this is where we are hoping that the nephrology world, which has been supportive, would like to see. What we would like to show is, in fact, that there is an impact. Now, there are publications that are coming out that Dr. Bishop is pushing, and obviously, the guidelines will have to be changed, so that takes time. As you know, medical practice is not something you can change overnight, but we're optimistic. Now, is this going to be, you know, a short-term big bang for Royalty? I don't think so, honestly. I think it's going to take time to sink in to the practice world.

Speaker Change: To be able to raise the levels of vitamin D to the levels where the parathyroid hormone goes down is reality. We've shown that before, so it's not new. However, what we haven't shown, and this is where we are.

Michael Petusky: We've shown that before, so it's not new. However, what we haven't shown, and this is where we are hoping that the nephrology world, which has been supported, would like to, what we would like to show is, in fact, that there is an impact. Now, there's their applications coming out that Dr. Bishop is pushing, and obviously the guidelines will have to be changed. So that next time, as you know, medical practice is not something you can change overnight. But we're optimistic. Now, is this going to be a, you know, a short-term big bang for Ray Aldi?

Elias Zerhouni: We've shown that before, so it's not new. However, what we haven't shown, and this is where we are hoping that the nephrology world, which has been supportive, would like to see. What we would like to show is, in fact, that there is an impact. Now, there are publications that are coming out that Dr. Bishop is pushing, and obviously, the guidelines will have to be changed. So that takes time, as you know. Medical practice is not something you can change overnight, but we're optimistic. Now, is this going to be a short-term, big bang for Royalty? I don't think so, honestly. I think it's going to take time to sink in to the practice world.

Speaker Change: Hoping that the nephrology world, which has been supportive, would like to...

Speaker Change: What we would like to show is, in fact, that there is an impact. Now, there are publications that are coming out that Dr. Bishop is...

Speaker Change: Though, we do have a full list of what the program is for. There's a phd program, there's an automatic shift center program. There's a treatment center, there's a behavioral therapy center, there's one that's on masks and seatbelts and nothing else. Except different areas. So in a way I think we're on a cycle, because I would welcome it if you would work with vedereign to get a better understanding of what clinical practice is, but at the same time I would welcome it if you could run from

Michael Petusky: I don't think so, honestly. I think it's going to take. time to sink in into the practice world.

Speaker Change: Big bang for royalty. I don't think so. Honestly, I think it's going to take time to sink in into the practice world.

Michael Petusky: I can ask one last question that sort of links both of the questions I've already asked so far. Is there any rationale for trying to buy maybe a commercial product that could be marketed to your nut nephrologist just to give the Rhealdi sales team just another arrow in the quiver? Sure. I mean, would something like that make sense, or there's just nothing out there that really would fit like that in terms of potentially looking at that as a source of capital allocation priority. I'll answer that, then. Your question is a good one; it's perfectly rational, and I will tell you that we have been looking for opportunities of that sort. If you come across one, please let us know.

Michael Petusky: Can I ask one last question that sort of links both of the questions I've already asked so far? Is there any rationale for trying to buy maybe a commercial product that could be marketed to nephrologists just to give the reality sales team another arrow in the quiver? I mean, would something like that make sense, or is there just nothing out there that would fit like that in terms of, you know, potentially looking at that as a source of, you know, capital allocation priorities?

Michael Petusky: Can I ask one last question that sort of links both of the questions I've already asked so far? Is there any rationale for trying to buy maybe a commercial product that could be marketed to nephrologists just to give the Realty sales team another arrow in the quiver? I mean, would something like that make sense, or is there just nothing out there that would fit like that in terms of, you know, potentially looking at that as a source of, you know, capital allocation priorities?

Speaker Change: Can I ask one last question that sort of links both of the questions I've already asked so far? Is there any rationale for trying to

Speaker Change: by maybe a commercial product that could be marketed to your nephrologist just to give the reality sales team just another arrow in the quiver. I mean, would something like that make sense, or is there just nothing out there that really would...

Speaker Change: would fit like that in terms of...

Speaker Change: you know, potentially looking at that as a source of, you know, capital allocation priority things.

Elias Zerhouni: I'll answer that then. Your question is a good one, it's perfectly reasonable, and I will tell you that we have been looking for opportunities of that sort. And if you come across one, please let us know. Fair enough.

Michael Petusky: Fair enough. All right. Thank you.

Speaker Change: I'll answer that then.

Speaker Change: your question is a good one it's perfectly rational and our we'll tell you that we have been looking for opportunities of that short and if if you come gross one please let us know

Michael Petusky: Fair enough. All right.

Michael Petusky: Fair enough. All right. Thank you.

Michael Petusky: Thank you.

Speaker Change: Fair enough. All right. Thank you.

Operator: Hey, ladies and gentlemen, this concludes today's question-and-answer session.

Phillip Frost: And ladies and gentlemen, this concludes today's question and answer session. I would like to turn the conference back over to Dr. Frost for any closing remarks.

Speaker Change: And ladies and gentlemen, this concludes today's question and answer session. I would like to turn the conference back over to Dr. Frost for any concluding remarks.

Phillip Frost: I would like to turn the conference back over to Dr. Frost for any concluding remarks. Well, I just want to thank everybody for your participation and for your good questions, and we look forward to meeting with you again after our next quarter's results.

Phillip Frost: Well, I just want to thank everybody for your participation and for your good questions. And we look forward to meeting with you again after our next quarter's results. Thank you, and have a good evening.

Dr. Frost: Well I just want to thank everybody for your participation and for your good questions and we look forward to meeting with you again after our next quarter's results.

Operator: Thank you and have a good evening. Thank you.

Operator: Thank you. The conference has now concluded. Thank you for attending today's presentation.

Operator: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Operator: The conference has now concluded. Thank you for attending today's presentation.

Speaker Change: Thank you and have a good evening. Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

Operator: You may now disconnect. Thank you.

Speaker Change: Thank you.

Q2 2024 OPKO Health Inc Earnings Call

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