πŸ“’ New Earnings In! πŸ”

OPK (2025 - Q2)

Release Date: Jul 31, 2025

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Stock Data provided by Financial Modeling Prep

Current Financial Performance

OPK Q2 2025 Financial Highlights

$101.1M
Diagnostics Revenue
$55.7M
Pharmaceutical Revenue
$148.4M
Net Loss
$0.19
EPS

Key Financial Metrics

Diagnostics Operating Loss

$18.2M

Improved from $26.6M in Q2 2024

Pharmaceutical Operating Loss

$28.7M

Up from $24.8M in Q2 2024

R&D Expenses

$29.8M

Up from $23.7M in Q2 2024

BARDA Funding Q2 2025

$6.5M

Up from $5M in Q2 2024

Cash & Equivalents

$285M

Period Comparison Analysis

Diagnostics Revenue

$101.1M
Current
Previous:$129.4M
21.9% YoY

Pharmaceutical Revenue

$55.7M
Current
Previous:$52.8M
5.5% YoY

Diagnostics Operating Loss

$18.2M
Current
Previous:$26.6M
31.6% YoY

Pharmaceutical Operating Loss

$28.7M
Current
Previous:$24.8M
15.7% YoY

Net Loss

$148.4M
Current
Previous:$10.3M
1340.8% YoY

Net Loss

$148.4M
Current
Previous:$67.6M
119.5% QoQ

Earnings Performance & Analysis

EPS Q2 2025

$0.19

Improved from $0.01 in Q2 2024

Q2 2025 BARDA Revenue vs 2025 Guidance

Actual:$6.5M
Estimate:$5M
BEAT

4Kscore Test Volume Growth

12%

Financial Guidance & Outlook

2025 Total Revenue Guidance

$640M - $660M

2025 R&D Spending Guidance

$120M - $130M

2025 BARDA Funding Guidance

$30M - $35M

Oncology Asset Sale Proceeds

$192.5M at closing

Surprises

Diagnostics Revenue Decline

$101.1 million

Diagnostics revenue for Q2 2025 was $101.1 million, down from $129.4 million in Q2 2024, primarily due to the Labcorp oncology asset sale.

4Kscore Test Volume Increase

+12%

12%

The 4Kscore test continued to perform well with year-over-year increase in test volume of approximately 12%.

BARDA Funding Increase

$6.5 million

BARDA funding increased to $6.5 million from $5 million, reflecting the expanded program activity for our infectious disease antibody programs.

Net Loss Increase

$148.4 million

Net loss for Q2 '25 was $148.4 million or $0.19 per share compared to $10.3 million or $0.01 per share in Q2 2024 due to a $92 million convertible note expense.

Pharmaceutical Revenue Growth

$55.7 million

Pharmaceutical revenue was $55.7 million, up $2.9 million from 2024's $52.8 million.

Diagnostic Operating Loss Improvement

$18.2 million

Diagnostic operating loss improved to $18.2 million compared to $26.6 million in Q2 2024.

Impact Quotes

We're confident that this strategy will continue to add value in the second half of 2025 and beyond.

We believe that OPK-88006 could be a promising GLP-1/glucagon receptor dual agonist for the treatment of obesity and MASH.

We remain on track to achieve cash flow breakeven and positive cash from operations in 2025.

The disposition of the 2 parts of BioReference so far are good examples of that. And the remaining part is certainly becoming a more valuable asset.

The FDA approval of the supplemental application for the 4Kscore test should provide further opportunities for growth.

We completed the convertible note exchange earlier this quarter using approximately $65 million in cash and issuing 121 million shares, which meaningfully improved our overall debt position.

Our collaboration with Entera Bio continues to advance as we're in the pre-IND stage with an oral version of OPK-88006.

We consider our R&D expenditures to be interesting and good investments in the sense that many of the projects are quite novel and high-risk.

Notable Topics Discussed

  • OPKO is streamlining BioReference Health by preparing to sell its oncology and related clinical testing assets to Labcorp for $225 million, with $192.5 million payable at closing and an earn-out of up to $32.5 million based on performance.
  • The sale aims to monetize assets, sharpen focus on core testing operations, and improve financial profile.
  • Post-transaction, BioReference will retain core clinical testing in NY and NJ, including proprietary tests like 4Kscore, and expand into direct-to-consumer and employer-based testing.
  • Management emphasizes that this strategic move is expected to enhance margins and position BioReference for profitability.
  • On July 25, FDA granted approval for a supplemental application for the 4Kscore test.
  • This approval allows the test to be performed without digital rectal examination information.
  • The 4Kscore test assesses the likelihood of aggressive prostate cancer in men 45+ and is now more accessible to primary care providers.
  • Management sees this as a growth opportunity, especially with over 90% of PSA tests performed by primary care providers in the U.S.
  • The test's margin profile and recent approval are expected to drive increased testing volumes.
  • OPK-88006 demonstrated superior preclinical results over semaglutide and survodutide in mouse models for obesity and MASH.
  • The drug's dual mechanism enhances metabolism and may have anti-fibrosis effects via FGF21.
  • Collaboration with Entera Bio is progressing on an oral tablet formulation using proprietary N-Tab technology, with encouraging bioavailability data presented at ENDO.
  • The program aims to address unmet needs in obesity and MASH, with clinical trials expected to start in late 2025 or early 2026.
  • Management highlights the potential for both injectable and oral forms to improve patient adherence and outcomes.
  • OPKO is collaborating with Entera Bio on an oral GLP-2 formulation for short bowel syndrome, an unmet medical need.
  • The program aims to improve nutrient absorption and reduce reliance on parenteral nutrition.
  • Abstract on pharmacokinetics and pharmacodynamics was accepted for presentation at ESPEN Congress in September 2025.
  • Clinical study initiation is anticipated in 2024 or 2025, depending on regulatory approval.
  • This represents a distinct, non-obese indication targeting a different patient population with significant unmet needs.
  • OPKO's immuno-oncology programs include a tetraspecific T cell engager antibody (MDX2001) progressing to its fifth dose level in Phase I trials.
  • Additional programs include MDX2003 for lymphoma/leukemia and MDX2004 as an immune rejuvenator, with clinical entry expected late 2025 or early 2026.
  • Funding from BARDA has supported these efforts with over $110 million combined in 2022 and 2023, including $59 million last year and $51 million so far this year.
  • The focus is on immune-impaired patients, including those with cancer, chronic diseases, and the elderly, addressing significant unmet medical needs.
  • OPKO's Phase I trial for the EBV vaccine, partnered with Merck, is progressing as planned.
  • The trial evaluates safety and tolerability in up to 200 healthy adults, with results expected to guide Phase II decisions.
  • This vaccine aims to prevent Epstein-Barr Virus infections, which are linked to various cancers and diseases.
  • Success could position OPKO as a leader in viral vaccine development, with significant commercial and public health implications.
  • OPKO completed a convertible note exchange, eliminating over $159 million in debt and recording a $92 million expense in Q2.
  • The company has a $200 million share repurchase program, with $141.5 million remaining as of June 30.
  • Management emphasizes strategic deployment of capital, including buybacks and partnerships, to maximize shareholder value.
  • The balance sheet improvements and capital allocation are aimed at supporting ongoing R&D and operational efficiency.
  • BioReference's restructuring includes footprint consolidation and a reduction in force, saving approximately $19 million annually.
  • Post-transaction, headcount is expected to decrease to 1,450-1,500 by Q4 2025.
  • Operational efficiencies are expected to lead to positive cash flow and profitability in the Diagnostics segment during 2025.
  • FDA approval of the 4Kscore test supplement is expected to further boost test volumes and margins.
  • OPKO is advancing multiple Phase I programs, including immuno-oncology, infectious disease, and metabolic therapies.
  • The company expects to file five new INDs within the next 12 months, covering GLP-1, oncology, immunology, and infectious disease.
  • R&D investments increased to nearly $30 million in Q2, reflecting focus on high-potential, high-risk projects.
  • Management views these investments as strategic, aiming for significant future returns despite inherent risks.
  • OPKO expects to close the Labcorp oncology asset sale later in 2025, with proceeds of up to $225 million.
  • Full-year 2025 revenue guidance is $640-$660 million, with specific contributions from services, products, and collaborations.
  • The remaining business is expected to reach cash flow breakeven and profitability in 2025, independent of growth levels.
  • Management emphasizes that profitability is achievable even without significant top-line growth, due to cost reductions and asset monetization.

Key Insights:

  • A $100 million gain on the oncology transaction is anticipated to reduce operating expenses and increase operating income in the closing quarter.
  • BARDA funding is expected to be $30 million to $35 million in 2025, partially offsetting R&D expenses.
  • Full year 2025 revenue guidance is $640 million to $660 million, including $95 million to $105 million from oncology assets and $28 million to $35 million Pfizer profit share.
  • OPKO expects to close the second Labcorp oncology transaction near the end of Q3 2025, with $192.5 million payable at closing and potential earn-out up to $32.5 million.
  • OPKO plans to continue share repurchases under the $200 million authorization, with $141.5 million remaining as of June 30.
  • Post oncology transaction, BioReference is expected to reach cash flow positive and profitability during 2025, excluding nonrecurring and noncash items.
  • Total costs and expenses for 2025 are expected between $835 million and $865 million, including $15 million to $20 million in one-time restructuring costs and $120 million to $130 million in R&D spending.
  • BioReference's recent FDA approval for the 4Kscore test supplemental application allows use without digital rectal exam information, expanding potential primary care users.
  • BioReference will focus on core clinical testing in New York and New Jersey, urology diagnostics including the proprietary 4Kscore test, and clinical services for correctional facilities.
  • Collaboration with Entera Bio is advancing oral tablet formulations of OPK-88006 (GLP-1/glucagon agonist) and a GLP-2 candidate for short bowel syndrome.
  • Latin American pharmaceutical operations and Irish contract manufacturing unit showed revenue growth and margin expansion despite foreign currency headwinds.
  • ModeX has two programs in Phase I trials with three more expected to enter the clinic late 2025 or early 2026.
  • OPKO is streamlining BioReference Health operations, preparing to close the sale of oncology and related clinical testing business to Labcorp.
  • The Phase I EBV vaccine trial with Merck is progressing; Phase I data will guide Phase II decisions.
  • Adam Logal discussed financial discipline, improved debt position after convertible note exchange, and ongoing share repurchase program to enhance shareholder value.
  • Dr. Elias Zerhouni highlighted BioReference's restructuring efforts, cost savings of approximately $19 million annually, and focus on local physician markets to increase testing volumes.
  • Dr. Phillip Frost emphasized strategic asset monetization and focus on shareholder value through partnerships, business development, and asset sales.
  • Elias noted the promising preclinical and clinical progress of OPK-88006 for obesity and MASH, including superior results to semaglutide and survodutide in mouse models.
  • Leadership remains optimistic about Pfizer's efforts to grow NGENLA sales despite slower-than-expected adoption of long-acting hGH globally.
  • Management acknowledged the high-risk nature of R&D projects but emphasized their potential significant returns and importance as investments.
  • Management expressed confidence in the therapeutic pipeline, including multi-specific antibodies for oncology and immunology, and the potential of oral formulations to improve patient adherence.
  • 4Kscore test volumes increased 12% year-over-year with acceleration in July, and FDA label change expected to further expand market opportunity.
  • BARDA revenue for Q2 2025 was $6.5 million, with full-year guidance of $30 million to $35 million.
  • Capital allocation priorities include continued R&D investment, share repurchases, and maintaining a strong balance sheet with non-dilutive funding partnerships.
  • Diagnostics EBITDA loss narrowed in Q2 2025, with expected cost reductions post-oncology transaction to achieve cash flow breakeven and positive cash flow in 2025.
  • GLP-2 candidate for short bowel syndrome addresses a distinct unmet need related to intestinal absorption and malnutrition, with clinical study expected next year.
  • Management expects NGENLA prescription trends to improve in the U.S. and international markets to work through inventory, with optimism for the remainder of 2025.
  • OPK-88006 differentiation includes metabolic benefits via glucagon and potential anti-fibrosis effects through FGF21, with oral formulation offering patient convenience and regimen stabilization.
  • Phase I trials for OPK-88006 will focus on obese patients with biomarker evidence of MASH, targeting safety and biomarker trends rather than definitive efficacy.
  • BARDA has provided $59 million in non-dilutive funding in 2024 and $51 million so far in 2025 to support infectious disease antibody programs.
  • BioReference headcount reduced to approximately 1,900 in Q2 2025, expected to decrease to 1,450-1,500 post-oncology transaction closure.
  • Cash used in operations increased in Q2 due to working capital adjustments, lease exit payments, and income taxes related to 2024 transactions.
  • ModeX's MDX2001 tetraspecific T cell engager antibody is in Phase I dose escalation, with plans to assess efficacy signals in tumors expressing Trop2 or CMet.
  • NGENLA holds about one-third of the global long-acting hGH market, with ongoing transition to once-weekly dosing.
  • OPKO invested approximately $8 million into Entera Bio related to the oral GLP-1 program during Q2 2025.
  • The 4Kscore test is indicated for men 45 years or older with elevated or abnormal PSA screening results, with over 90% of PSA tests performed by primary care providers.
  • Management highlighted the importance of maintaining infrastructure at BioReference to support the closing of the oncology transaction.
  • Management is focused on optimizing capital structure while maintaining investments in innovative R&D programs.
  • Management is mindful of balancing share repurchases with funding R&D and leveraging partnerships for non-dilutive cash sources.
  • The company anticipates that the remaining BioReference business will be more efficient and profitable after the second asset sale.
  • The company is pursuing multiple IND filings within 12 months for GLP-1 glucagon, oncology, immunology, and infectious disease programs.
  • The oral GLP-1 program combines OPKO's proprietary long-acting oxyntomodulin analog with Entera's N-Tab technology.
  • The oral GLP-2 program for short bowel syndrome was accepted for presentation at the ESPEN Congress in September 2025.
Complete Transcript:
OPK:2025 - Q2
Operator:
Good day, and welcome to the OPKO Health Second Quarter 2025 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead. Yvonne B
Yvonne Briggs:
Thank you, operator, and good afternoon. This is Yvonne Briggs with Alliance Advisors IR. Thank you all for joining today's call to discuss OPKO Health's financial results for the second quarter of 2025. 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, are subject to risks and uncertainties that could materially affect the company's results. These 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, 2024, and subsequently filed SEC reports. Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, July 31, 2025. 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 for 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 as well as OPKO's Pharmaceutical business. After that, Adam Logal, OPKO's Chief Financial Officer, will review the company's second quarter financial results and discuss OPKO's financial outlook, and then we'll open 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 will report on the continued progress of OPKO Health's strategic initiatives and business performance. We have streamlined BioReference Health's operations as we prepare to close the sale of its oncology and related clinical testing business to Labcorp. This transaction monetizes certain assets while sharpening BioReference's focus on its core testing business and improving its financial profile. This is our second transaction with Labcorp to unlock value and accelerate BioReference's path to profitability. On the pharmaceutical side, we continue to advance our innovative therapeutic pipeline. ModeX has 2 programs in Phase I clinical trials with 3 more expected to enter the clinic late this year and early 2026. A significant catalyst for our pipeline is the Phase I data from our EBV vaccine partnered with Merck that will guide decisions regarding Phase II testing. We're pleased with the progress of our collaboration with Entera Bio to develop an oral tablet formulation of OPK-88006, our GLP-1/glucagon agonist for the treatment of obesity and MASH. Oral administration of this drug candidate has demonstrated encouraging results in animal models with in vivo data presented at the ENDO Annual Meeting in mid-July. OPKO is independently developing OPK-88006 for subcutaneous administration with in vivo data having been presented at the American Diabetes Association 85th Scientific Sessions in June. We are also collaborating with Entera Bio on a second program to develop an oral form of our GLP-2 candidate for short bowel syndrome. Our Latin American business and our Irish contract pharmaceutical development and manufacturing unit continued to perform well with increasing revenue and expanding margins even while facing foreign currency headwinds. We've taken several strategic steps to improve our balance sheet and have sufficient capital to allocate to our R&D efforts, which are partially funded by strategic partners and non-dilutive sources. In addition, we have a $200 million common stock repurchase program in place with $141.5 million remaining capacity as of June 30. As you've noted, we're committed to maximizing shareholder value through the strategic deployment of capital, additional partnerships, business development initiatives and asset sales. We're confident that this strategy will continue to add value in the second half of 2025 and beyond. With that overview, I'll turn the call over to Elias.
Elias Adam Zerhouni:
Thank you, Phil, and good afternoon, everyone. Let's start with an update on BioReference Health, our Diagnostics segment. We continue to restructure and right-size this business toward the goal of reaching and sustaining profitability. You will recall that in March, we announced an agreement with Labcorp to sell our oncology assets for $225 million with $192.5 million payable at closing and an earn-out of up to $32.5 million based on performance. And the earn-out will be measured 6 months post close and is based on the number of specified client accounts that are retained. We expect this transaction to close near the end of the third quarter of this year. With the pending sale of BioReference Oncology and related clinical testing assets to Labcorp, we expect the remaining business to show improving margins through the balance of the year and beyond. Post transaction, BioReference will maintain its core clinical testing operations in New York and New Jersey, and will continue to offer urology diagnostic services, highlighting our proprietary 4Kscore test for prostate cancer risk assessment as well as its clinical services business with correctional facilities on a nationwide basis. The revenue of these operations represented approximately $300 million in 2024. Now reflecting our efforts to drive operational efficiencies, BioReference's financial results continue to improve. As I mentioned in our last call, the latest reduction in force and footprint consolidation provided annualized cost savings of approximately $19 million, our headcount stands now at approximately 1,900 for the second quarter. After the close of the oncology transaction, we expect our headcount to decrease to between 1,450 and 1,500 by the fourth quarter. Now, to further grow the business, we have focused our efforts on optimizing our test menu and establishing strategic relationships in market to increase testing volumes. By focusing on the local New York and New Jersey physician markets, we have really strengthened our position with those who'd serve this patient base. And this includes ACOs, IPAs, FQHCs, regional health systems and specialty health care companies. And in addition, the combination of our menu size and operational agility as a more focused company is instrumental in capitalizing on new revenue streams such as direct-to-consumer, employer-based testing and early phase clinical trials. We are also pleased to announce that on July 25, the FDA granted approval of a supplemental application for the 4Kscore test. And this approval specifically enables the performance of the 4Kscore test even when digital rectal examination information is not available. The 4Kscore test is indicated for the assessment of the likelihood of aggressive prostate cancer in men 45 years or older and reported to have age-specific elevated or abnormal screening PSA results. In the U.S., over 90% of PSA screening tests are performed by primary care providers who will now be potential users of the 4Kscore test. Excluding the pending and closed assets sales, BioReference's testing volume grew by 1.4% in the second quarter of 2025 compared with the year ago period. As for our urology segment, the 4Kscore test continued to perform well with year-over-year increase in test volume of approximately 12%. Now, the aforementioned FDA approval of our supplemental application for the 4Kscore test should provide further opportunities for growth, we believe. Now, let's turn to a discussion of our therapeutics segment, starting with ModeX. The Phase I Epstein-Barr virus vaccine trial by our Merck collaborators is progressing as planned. This trial will evaluate up to 200 healthy adults for safety and tolerability and is comprised of 2 parts with a different adjuvant for each. We're currently waiting for the analysis of the Phase I results that will guide Merck's decisions on progression to Phase II trials. Several products are advancing in our immuno-oncology and immunology portfolio. The most advanced is our first-in-class MDX2001 CMet-Trop2/CD3-CD28 tetraspecific T cell engager antibody that has progressed to its fifth dose level in the Phase I clinical trial. We expect to enroll the highest dose level by the end of the year, after which we will focus on assessing signals of efficacy in select tumors known to express high levels of Trop2 or CMet at biologically active doses. And thereafter, we will focus on the tumors that appear most responsive. Now, 2 additional programs are expected to enter the clinic late this year or early next year, including our MDX2003 tetraspecific T cell engager antibody for lymphoma and leukemia and the MDX2004, an immune rejuvenator for multiple oncology and immunology indications. Our immunology portfolio is focused on the use of multi-specific antibodies for immune-impaired patients, including those with cancer, chronic diseases and the elderly. Our most advanced product aims to address the unmet need in such patients with high risk for COVID complications, and we anticipate that Phase I studies will begin early next year. And this work, as you remember, is funded by BARDA, which is also supporting the advancement of multi-specific antibodies to prevent influenza currently at the pre-IND stage. And we continue to work collaboratively with BARDA which contributed non-dilutive funding of $59 million last year and an additional $51 million so far this year to advance these programs. Now, as mentioned by Dr. Frost, moving to OPK-88006, our novel long-acting GLP-1 receptor, glucagon receptor dual agonist, we presented a poster on preclinical data at the American Diabetes Association 85th Scientific Session in June and the therapeutic benefits of OPK-88006 on quantitative, biological hallmarks of MASH in mouse models were superior to semaglutide and survodutide, suggesting that OPK-88006 could be a promising GLP-1/glucagon receptor, dual agonist for the treatment of obesity and MASH. We are encouraged by these results and OPK-88006's therapeutic potential. As Phil mentioned, our collaboration with Entera Bio continues to advance as we're in the pre-IND stage with an oral version of OPK-88006. The oral program combines our proprietary long-acting oxyntomodulin analog and Entera's proprietary N-Tab technology. At the recent ENDO meeting in San Francisco, we presented new pharmacologic and pharmacokinetic in vivo data for oral OPK-88006 showing excellent bioavailability. In addition, we're working with Entera Bio on another program for short bowel syndrome, which represents a significant unmet need. Short bowel syndrome patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals. The European Society for Clinical Nutrition and Metabolism Congress, or ESPEN, accepted our abstract regarding the PK/PD of our oral GLP-2 tablet for the treatment of short bowel syndrome, and this presentation will take place in September in Prague. Finally, our Latin American Pharmaceutical division and Rayaldee continued to perform to plan with sustained revenues and margins, and Adam will provide you also an update on NGENLA. So in summary, we're pleased with our progress in advancing our first-in-class therapeutic multi-specific antibodies for oncology and immunology indications as well as our multi-vaccine candidate that are progressing in clinical development at Merck and our metabolic disease program with our OPK-88006 GLP-1 GLP-1/glucagon antagonist in both oral and injectable forms for obesity and MASH as well as an oral GLP-2 agonist for short bowel syndrome. We're confident that the restructuring efforts we're undertaking will position BioReference to be more efficient and profitable following the completion of the second asset sale. Now, let me turn the call over to Adam to discuss our financial results. Adam?
Adam E. Logal:
Thank you, Elias. Let's begin with our Diagnostics business. Revenue for the second quarter of 2025 was $101.1 million, including $24.9 million from the oncology assets being sold. This compares with $129.4 million in Q2 2024 with the decline primarily due to the Labcorp transaction that closed in September of 2024. Revenue in our non-oncology business continues to see steady growth, highlighted by an increase in 4Kscore volumes of nearly 12%, which Elias mentioned, and has been accelerating throughout the year. Total costs and expenses were $119.3 million, down from $156 million last year. This includes $29.4 million related to the oncology assets and approximately $2 million in expected onetime costs for severance during the 2025 quarter. As a result, our Diagnostic operating loss improved to $18.2 million compared to $26.6 million in Q2 2024. Depreciation and amortization expense came in at $4.9 million, down from $6.3 million in 2024. Importantly, as Elias mentioned, the actions we've taken throughout the first half of this year and those planned as we close the oncology transaction, are expected to deliver over $25 million in annualized cost savings, and we remain on track to achieve cash flow breakeven and positive cash from operations in 2025. Turning to our Pharmaceutical business. Revenue was $55.7 million, up $2.9 million from 2024's $52.8 million. Product revenue was $40.7 million, up slightly from 2024's $40.5 million, reflecting an increase in our Spanish and Mexican businesses, partially offset by foreign exchange headwinds in Chile. Rayaldee contributed $7.2 million in both the 2025 and 2024 periods with improved margins during 2025 due to the lower government rebates. IP transfer revenue rose to $15 million, up from $12.3 million, which includes our Pfizer profit share of $6.1 million compared to $6.3 million for 2024. While the first half of 2025 gross profit share has been slower than we anticipated, we are optimistic about the efforts Pfizer has made and expect to make throughout the remainder of 2025 on the global commercialization efforts of the program. Globally, the adoption of the long-acting form of hGH has been slower than we and the broader market has anticipated. However, we continue to see trends of accelerated transition to the once-weekly formulation. Based on the available market data, NGENLA holds about 1/3 of the global long-acting market. And as the market continues to move to the once-weekly dosing, we believe Pfizer will continue to grow its portion of the total market. In addition, BARDA funding increased to $6.5 million from $5 million, reflecting the expanded program activity for our infectious disease antibody programs. Costs and expenses were $84.4 million, up from $77.6 million, driven by increased R&D investments. R&D totaled $29.8 million, up from $23.7 million, primarily due to the ModeX development programs, including our BARDA supported programs. As Elias mentioned, we are making progress within our clinical development program and with spending on our ongoing Phase I trial as well as expenses to support an additional 5 IND filings within the next 12 months for our GLP-1 glucagon, oncology, immunology and infectious disease programs. As a result, our pharmaceutical operating loss was $28.7 million compared to $24.8 million last year. Depreciation and amortization expense was $18.1 million, slightly more than 2024's $17.9 million. For our consolidated results, consolidated operating loss improved slightly during 2025 to $60 million compared to $61.7 million as a result of the improved results at BioReference, partially offset by the increased investments in our pharmaceutical research and development programs. As you'll recall, we completed our convertible note exchange on April 1, 2025. As a result, we recorded approximately $92 million of expense during the second quarter of 2025, while our 2024 net loss benefited from an increase in the value of one of our investments, which resulted in a gain of $60 million during 2024. As a result, our net loss for Q2 '25 was $148.4 million or $0.19 per share compared to $10.3 million or $0.01 per share in Q2 2024. As we think about our balance sheet and capital allocation, we ended the quarter with approximately $285 million in cash, cash equivalents and restricted cash. We remain focused on optimizing our capital structure while maintaining our investments into our innovative R&D programs. As I mentioned, we completed the convertible note exchange earlier this quarter using approximately $65 million in cash and issuing 121 million shares, eliminating over $159 million in principal debt, which meaningfully improved our overall debt position. Under our expanded share repurchase authorization, as Phil mentioned, we repurchased approximately 13.6 million shares during Q2 '25 and have approximately $142 million remaining authorized, which represents more than 13% of our current share count at recent trading ranges. Cash used in operations during Q2 increased from our normal levels due to certain working capital adjustments, including a negotiated lease exit for one of our BioReference facilities as well as income taxes paid on our transactions that closed in 2024. We also invested approximately $8 million into Entera Bio related to our oral GLP-1 program. Looking forward, we expect to close our second Labcorp transaction later this year, which will bring in $192.5 million at closing with potential proceeds of up to $225 million. As we move to our outlook, we continue to execute our multiphase plan to drive profitability in our Diagnostics business by reducing the fixed infrastructure costs and improving our operational efficiency. Following the oncology transaction, the remaining BioReference business is expected to reach cash flow positive and profitability during 2025. This will exclude nonrecurring and noncash items, and we have not adjusted our outlook for the closing of the oncology transaction, but we'll do so once the closing date is certain. For the full year 2025 outlook, we expect total revenue to be between $640 million and $660 million; revenue from services of $405 million to $425 million, including $95 million to $105 million from our oncology assets; revenue from products of $160 million to $170 million and other revenue of $65 million to $75 million, including our Pfizer profit share of $28 million to $35 million, support from BARDA of $30 million to $35 million. Total costs and expenses are expected to be between $835 million and $865 million, excluding $15 million to $20 million of onetime restructuring costs for our Diagnostics business. This includes $125 million to $135 million in expenses related to our oncology assets. It includes $120 million to $130 million of research and development spending, which will be partially offset by $30 million to $35 million in BARDA funding. We expect depreciation and amortization expense to be approximately $90 million, and we also anticipate a $100 million gain on the oncology transaction, which will reduce operating expenses and increase operating income in the quarter which we close. With that, I'd like to open up the call for questions. Operator?
Operator:
[Operator Instructions] Our first question comes from Maury Raycroft with Jefferies.
James D Stamos:
This is James on for Maury. Congrats on the update. Given that new prescriptions and total prescriptions for NGENLA were up in 2Q, do you expect that the $6.1 million in NGENLA/Genotropin profit share in 2Q was due to lower gross-to-net from co-pay assistance in 1Q carrying over to 2Q? And have you received any insights from Pfizer on 2Q sales? Or do you plan to follow up with them for clarification? And I have a follow-up.
Phillip Frost:
James, thanks for the questions. And we definitely saw an improvement in the U.S. market as it relates to the prescription trends that you identified. We continue to see some of the international markets that are in the early days of launches continuing to work through some of the higher cost inventory that's set out there. So, we expect the remainder of the year to pick back up to the traditional levels but we saw strength broadly across all of the geographic markets for NGENLA. So, we're pretty optimistic of where that's headed.
James D Stamos:
Got it. And then a follow-up is, how is EBITDA margin for the Diagnostics business tracking in 2Q versus 1Q? And how are you setting expectations for EBITDA profitability in 3Q and 4Q? And kind of going along with that, this approval with the supplemental application for the 4Kscore test. Can you talk about implications for growth in 4Kscore test sales in the coming quarters?
Adam E. Logal:
Yes. So, let me pull the EBITDA question apart. So, when we think about the Diagnostics segment, we're continuing to see quarter-over-quarter improvements in a lot of the steps we've taken to drive costs down are bearing fruit. If you were to look at the $18.2 million operating loss that resulted in Q2, consider the $2 million of nonrecurring expenses in there, you start to see that $4.5 million comes from the oncology business that is set to close later this year and depreciation and amortization expense of $4.9 million. It gets you to about a $6 million or a couple of million dollar a month loss in that segment. A lot of the costs, as Elias mentioned, are expected to come out when we close the oncology transaction in a couple of months' time and get our headcount even further down. We've been pretty judicious about making sure we maintain that business with the infrastructure at BioReference that's required to get through the closing. But once the closing occurs, we'll be able to bring the overall cost structure down as we planned. We feel we're on track to deliver those cost savings and to get to that cash flow positive basis this year, both from an EBITDA and a cash position. As it relates to 4Kscores, so we've seen really good upward growth on the test this year so far. We mentioned it's about 12% up. I think July, that really have started to accelerate, and that is before we have the FDA label change and really opens up the market for us to think about primary care docs being able to order the test. So, we think the upside is meaningful. And as I mentioned, being at 12% and meaningfully higher in July, we think, again, that the opportunity is pretty important. That test has a strong margin profile with a relatively small sales force calling on docs today.
Operator:
Our next question comes from Edward Tenthoff with Piper Sandler.
Edward Andrew Tenthoff:
So, my questions have to do with the obesity efforts. And specifically with an increasingly crowded landscape, how do you envision oxyntomodulin differentiating either as an injectable or with the oral formulation of its partner with Entera?
Elias Adam Zerhouni:
Yes. Thanks for the question. I mean, fundamentally, we think there is a differentiation because what we found out actually, and we studied the molecule that we created that not only is it effective in obesity, but glucagon increases the metabolism. But more importantly, glucagon has an effect downstream of glucagon on FGF21, which rises with our molecule. FGF21 is known actually to be anti-fibrosis or correct fibrosis as we know from other molecules that have been developed around FGF21. So, we believe, based on the results we have and then the preclinical data that show really a very good profile for the drug. Number one, we believe that it will have merits for MASH patients combined with obesity and diabetes. So, we will have to look at that. The second advantage, obviously, is that with Entera, we can create an oral form of the molecule. And frankly, that is something that in the information that we have from physicians is welcome because they like to stabilize the patient and convert them into oral forms to maintain the weight loss and maintain the effect over time without having to continue with the injectables. So, those are the 2 aspects. It has a biological aspect that we believe will be very valuable in MASH. And then it has a -- not just the convenience, but really a stabilization aspect of the regimen that you have to keep patients on to maintain the obesity reduction and the metabolic improvements that you hope to achieve.
Edward Andrew Tenthoff:
That's very helpful. And then when it comes to actually proving that out in the Phase I study, are there endpoints you're envisioning or different patient populations? Or how do you think you can actually tease that out in the clinical trials?
Elias Adam Zerhouni:
All right. So that's a great question. So, our plan is to really go into patients who have biomarker evidence of MASH and are obese, okay? And really go into that Phase I data on that population of patients that will eventually be of interest if we get both safety and some signal of efficacy with biomarkers. We're not going to do a biopsy study. We don't want to do that until we have good evidence that both the dose and the effect are really differentiating, okay? So that's the idea. And we're basically focused on patients who have, for example, liver stiffness, liver fat and evidence that they are not only obese, but they have a fatty liver that could lead to fibrosis eventually and liver failure. So, those are the patients we're going to focus on in Phase I with a cost that is quite reasonable. But then, obviously, these developments are quite expensive. We're not going to pursue that all on our own, and we have a lot of interest coming our way about potential collaborations once we achieve the data that we need to have to really create the value of the asset forward.
Operator:
Our next question comes from Yale Jen with Laidlaw & Company.
I-Eh Jen:
I just want to follow up what Ed just mentioned earlier. What do you -- what's your estimate of the size in terms of patients both have obesity as well as MASH? And would that be the specific sort of indication you're going to explore in the Phase I study when you presumably start later this year or early next year?
Elias Adam Zerhouni:
Yes. The answer is -- great question. The answer is, yes, we're focused on that population. We're going to try to focus on the patients that have biomarkers that indicate that they're in what we call F2, F3, F4 MASH -- degrees of MASH, stages of MASH. And those are the patients we're going to focus on. We're going to look for -- in Phase I for safety signals and dosing ranges, and we're not really looking for definitive efficacy, but we will look for biomarker trends that will help us. Now, in terms of total number of patients, it's hard to me to tell you the number but -- the exact number, but we're thinking between 100 and 170 patients to do the full Phase I.
I-Eh Jen:
Okay. Great. That's very helpful. Maybe one follow-up question here, which is, in terms of the collaboration you have with [Technical Difficulty] you have both 88006 and also you have a compound addressing short bowel syndrome. I'd just like to know a little bit -- get a little bit more color in terms of what's the difference between these 2 compounds and specifically for the short bowel syndrome compound that we probably not have too much ideas about.
Elias Adam Zerhouni:
Right. So, the GLP-1 glucagon receptor [ co-agonist ] is completely different than the GLP-2, right? GLP-2 is a separate molecule. and not at all in -- physiologically, not at all comparable to the GLP-1. I mean, although they have closed names, but they're not. And so, the GLP-2 has a huge function in actually intestinal absorption regulation. And that's why it's really something that a lot of people want to develop for people who have short bowel syndrome, malnutrition in tandem with that. So, it's an unmet need that has not been served very well. People get infusions of parenteral nutrition, infusion of food supplements and so on. And it's not as good as effective, and that's why the program was developed to address that unmet need, which is a completely separate population, completely different than the obesity MASH population we are trying to address with the GLP-1 glucagon. And now our collaboration with Entera is obviously adding an option, which is an oral version, which we find to be quite attractive to offer a spectrum of approaches from injectable to oral and vice versa.
I-Eh Jen:
Maybe to squeeze one more in here, which is when you anticipate this program to enter clinical study? Would that be next year?
Elias Adam Zerhouni:
Yes. I think so. Yes. And when exactly? I don't know. It depends on FDA, it depends on regulatory. But yes, I mean, definitely next year.
Operator:
Our next question comes from Yi Chen with H.C. Wainwright & Company.
Yi Chen:
My question is related to the long-acting GLP-1 receptor glucagon receptor dual agonist. So today, many patients taking GLP-1 drugs, they discontinue treatment due to GI side effects and also the current GLP-1 drug cause lean muscle mass loss as well as fat loss, which is a big problem for elderly patients. So, does your dual agonist has the potential to improve either of these 2 aspects of the current GLP-1 drugs on the market today?
Elias Adam Zerhouni:
I hope that on GI side effects, we will be able to titrate properly, and that's an open question. I can't tell you it will or will not. I think when you look at the data of others who have GLP-1 glucagon molecules, you might have the hope that, that will be the case. But every molecule is different. Ours is really, on a preclinical basis, has a very good profile. Now in terms of lean muscle mass, I don't think there will be a major difference. There may be one because glucagon is enhancing metabolism. But I don't think anybody knows the answer exactly. Some trials by Boehringer Ingelheim and others seem to show a little bit better profile, but I really wouldn't stick my neck out here and say we will definitely have better profiles on both of these counts. But I hope that we will because of the difference in metabolic action.
Operator:
Our next question comes from Michael Petusky with the Barrington Research.
Michael John Petusky:
Adam, I was writing as fast as I could, but not as quick as you were talking. What was the -- I don't think it's in the release. What was the BARDA revenue in the quarter? Was it $5.6 million, did you say?
Adam E. Logal:
Yes. So, BARDA revenue in the quarter, let me make sure I get it right. It was $6.5 million, yes, for the quarter.
Michael John Petusky:
[ $5-even ] or $5.6 million?
Adam E. Logal:
$6.5 million.
Michael John Petusky:
Sorry, $6.5 million. Okay. And the guide for revenue for BARDA for the year?
Adam E. Logal:
Sure. So, it was $30 million to $35 million for the year.
Michael John Petusky:
Okay. And then I guess, as you sort of think about the go forward after the oncology deal closes, does your assumption of sort of cash flow breakeven, et cetera, does that require a higher revenue run rate than sort of the, let's call it, $300 million annualized that will be left post the close? Or like essentially, does that top line have to grow in order to sort of achieve or can it sort of roughly stay around this level?
Adam E. Logal:
Yes. So, we've got plans for the revenue to grow, but achieving cash flow breakeven and being positive is not dependent on us achieving our growth plan.
Michael John Petusky:
And then I just want to, I guess, obviously, you've got cash on the balance sheet. You'll have more cash on the balance sheet presumably in the next 90 days or so. Could you guys just talk about capital allocation priorities for -- in terms of that balance sheet cash?
Adam E. Logal:
Yes. So, I'll start us off, Mike, and let Elias and others weigh in. As we kind of laid out early this year, we think about cash really for dollar-for-dollar of what we're spending or investing in the operations and R&D programs for us to be investing back into the balance sheet. And that's been pretty close to where we've been this year for the first half. I think we -- when we did the debt exchange in April, that accelerated the use of cash for our balance sheet strengthening a little bit faster than probably what we planned in January. But I'd say this year, we expected to use a little over $100 million in investing in R&D. We remain on track with that as it relates to how much cash we've put in our stock buyback program as well as the convertible debt exchanges, we're in the -- approaching $80 million so far this year and would expect to continue to buy back shares as opportunities exist. And as we think forward, it's probably not going to continue at that same accelerated pace on the capital side. We'll also be mindful of how we are able to partner any of our R&D programs to continue to try to find non-dilutive sources of cash to fund those programs and accelerate those like we did with our relationships with BARDA. So hopefully, that helps.
Michael John Petusky:
It does. Can I just ask maybe just a slight clarifying question. The stock obviously is, in my opinion, hasn't reacted much to sort of some of the improvements that you guys are making. It seems like you're on the path to making, particularly in the lab business. And I'm just curious, does that create, I guess, any extra urgency in terms of sort of completing the common share repurchase?
Adam E. Logal:
Yes. I mean I think the Board has authorized us to go up to that $200 million. So, we have about $142 million or $141.5 million left to deploy. And I don't think we will be shy about using it as the balance sheet allows.
Operator:
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Frost for any closing remarks.
Phillip Frost:
Thank you. Thank you all for your good questions and for participating in general. I'll close by observing that many of the things that we have talked about at previous meetings have really come to fruition. We have emphasized in the past the use of our assets in such a way that will be beneficial for the company and the shareholders. And the disposition of the 2 parts of BioReference so far are good examples of that. And the remaining part is certainly becoming a more valuable asset, which we're very happy about. So far as the expenditures are concerned, which are major for us, they're largely for R&D, and we consider those, as Adam mentioned, investments. And we consider them to be interesting and good investments in the sense that the -- many of the projects are quite novel. They're on the high-risk side, I would say. And so, we can't guarantee anything. But we also believe that the potential returns for these projects are significant. And it's for that reason that we feel good about what we're doing. So, I'll leave you with those thoughts. And again, thank you once again and look forward to being with you again a quarter from now.
Operator:
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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