OPKO Health Inc

NASDAQ:OPK

Earnings Call Analysis

Financial Results and Strategic Initiatives

For Q2 2024, OPKO Health reported a net loss of $10.3 million, improved from a $19.6 million loss in 2023. Diagnostic segment revenue grew 2% year-over-year to $129.4 million, while expenses dropped 9%, reducing the operating loss by 40%. The Pharmaceutical segment saw a drop in revenue to $52.8 million mainly due to a $90 million milestone payment in the prior year. Looking forward, OPKO expects Q3 gross profit share payments from Pfizer between $7 million and $9 million, and $15 million to $20 million for the second half of 2024. The Labcorp transaction is set to close by early October, anticipated to significantly aid in returning to profitability.

A Transformational Quarter for OPKO Health

In Q2 2024, OPKO Health experienced a mix of significant strategic transitions and improvements in financial results. The company continues to take critical steps towards enhancing shareholder value. The highlights of these efforts include key financial maneuvers, encouraging revenue performance, and significant ongoing projects in both its Diagnostics and Pharmaceuticals segments.

Financial Performance Overview

OPKO's revenues from its Diagnostics segment saw a modest increase of 2%, reaching $129.4 million, helped by strong performance in Oncology. However, the Pharmaceuticals segment witnessed a major downturn with revenues plunging to $52.8 million from $138.4 million the previous year, primarily due to the absence of a significant milestone payment that had boosted revenues last year. The net loss narrowed to $10.3 million from $19.6 million year-over-year. The company is adjusting its financial landscape by undertaking substantial cost-saving measures, reducing expenses by 9% overall.

Strategic Initiatives and Cost Management

OPKO is on track to close a significant transaction with Labcorp by late September or early October, which is expected to streamline operations and focus on core diagnostics, particularly in oncology. Post-transaction, employee numbers are anticipated to drop from 2,697 to around 2,100, contributing to a tighter cost structure. The company is instituting a multi-phase cost-reduction program that anticipates annual savings of approximately $25 million by the end of 2024, offsetting initial costs of about $40 million related to restructuring.

Guidance for Future Performance

Looking ahead, OPKO provided optimistic revenue guidance for Q3 2024, estimating total revenues between $180 million and $185 million. They project service revenues of $125 million to $129 million, which includes $24 million to $25 million from saleable assets to Labcorp. The revenue from product sales is estimated to range from $40 million to $43 million, including anticipated gross profit share payments from Pfizer between $7 million and $9 million. R&D expenses are expected to rise to between $24 million and $28 million to support various ongoing clinical trials.

Pharmaceuticals Segment Developments

The Pharmaceuticals segment remains a focal point for growth, particularly through ModeX programs. The company is gearing up to initiate Phase I clinical trials for its MDX2001 program targeting solid tumors, with patient dosing expected shortly. Additionally, milestones related to the growth hormone treatment, NGENLA, remain pivotal. OPKO expects gross profit share payments from Pfizer to rise towards $15 million to $20 million for the second half of 2024, reflecting manufacturing improvements and steady prescription growth.

Future Prospects and Shareholder Value

OPKO's strategic maneuvering, including a $100 million share buyback program, aims to strengthen its stock performance amid these transformative efforts. With a projected balance of under $240 million coming from Labcorp by year-end and financial flexibility improved through new financial arrangements, OPKO is looking to capture value through prudent allocations toward R&D and efficient operations. The integration of the Labcorp transaction is believed to put the company on the path toward breakeven or slight profitability, setting an optimistic horizon for OPKO's shareholders.

Earnings Call Transcript 2024-Q2

[Operator]

Good day, and welcome to the OPKO Health Second Quarter 2024 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 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.

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 could 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 in subsequently filed SEC reports. 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 we'll open up the call to questions.

Now I'd like to turn the call over to Dr. Frost.

[Phillip Frost, executive]

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 HealthCare Royalty that is secured by the gross profit share arrangement we have with Pfizer, our global commercial partner for NGENLA.

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 advance our R&D efforts for ModeX and its multispecific 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. In general, our long-acting growth hormone therapy continues to gain traction as Pfizer expands its launch with the product now being sold globally. NGENLA 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 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.

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. As for BioReference Health, we're making steady progress on the return to profitability, which will accelerate when we closed the announced transaction with Labcorp.

We are continuing to progress our collaboration with Entera Bio to develop oral tablet formulations of our proprietary long-acting GLP-2 peptide and oxyntomodulin analogues using Entera's proprietary N-Tab oral delivery technology. Entera 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 teduglutide, a GATTEX product. Pharmacology and incremental PK were expected early in the second half of 2024.

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

[Elias Zerhouni, executive]

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 BioReference Health operations to return to profitability.

Let me start with BioReference Health. We are 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 diagnostics business by enhancing our focus on core testing operations and supporting our efforts to reestablish profitability.

As an ongoing initiative, we continue to improve BioReference'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. For instance, at the end of Q2, 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.

This geographic refocusing of our operations will help further reduce our cost structures in coming quarters. 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 times.

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 a health system to run the specialty oncology tests in-house. 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 platforms. This enables us to stay best-in-class with our portfolio and brings value to our clients and the patients they serve. Our 4Kscore test for prostate transfer continues to perform well.

Now moving to our Pharmaceutical segment. I'd like to start with ModeX programs. And specifically, the MDX2001 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 I trial for our tetraspecific LASER program for solid tumors in the coming weeks. This Phase I open-label trial is expected to enroll 45 cancer patients with a variety of solid tumors, including lung, breast, prostate, and pancreatic cancers 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 6 clinical sites to evaluate safety, tolerability, and pharmacokinetics as well as early antitumor activity. Two sites are already enrolling patients. And 4 more will come online very promptly. 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 nondilutive 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. Merck is our collaboration partner who funds all preclinical work performed by the ModeX 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, early 2025.

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. BARDA, as we mentioned before, granted us $59 million to fund R&D and clinical evaluation through Phase I. 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 NGENLA. 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 shifts from the daily products. We're working with Pfizer on 2 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 2 indications.

Finally, Rayaldee 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. 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 will now turn the call over to Adam Logal to discuss our second quarter financial results. Adam?

[Adam Logal, executive]

Thank you, Elias. As Phil and Elias have discussed, the first half of 2024 was transformational for our balance sheet as we positioned ourselves to realize and demonstrate the inherent value of our assets for our shareholders. We initiated and completed 5 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 added 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. We announced the HealthCare Royalty financing transaction recently, pulling forward $250 million of cash while maintaining significant upside in the gross profit share payments in 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 GeneDx.

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. This includes opportunities 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 repurchases.

Before I move to the financial results for the quarter, I wanted to summarize the 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 receive from Healthcare Royalty. 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 4 years, 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. After the first 4 years, all payments from Pfizer will be retained by Healthcare 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 8 years with our downside models showing repayment within 10 years. The interest rate is based on SOFR plus 7.5% with a 4% SOFR floor.

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 and clinical testing businesses.

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. Operating loss for our Diagnostics 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.

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 Diagnostics 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 towards 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.

Moving to our Pharmaceuticals 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 NGENLA 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 approved against our expectations. Product revenue includes revenue from Rayaldee 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. 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 U.S. regulatory approval of NGENLA.

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. In addition, the second quarter of 2024 includes $5 million of other IP revenue related to our BARDA agreement. Costs and expenses for our Pharmaceuticals 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 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.

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 million and $17.8 million for the 2024 and 2023 second quarters.

Turning to our consolidated financial results. For the second quarter of 2024, we reported a net loss of $10.3 million or $0.01 per share compared with a net loss of $19.6 million or $0.03 per share for the 2023 period. Net loss for the second quarter of 2024 included a noncash 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 the nonrecurring $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 NGENLA. However, we continue to observe consistent prescription growth globally for NGENLA 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 NGENLA during the second quarter. And as a result, we believe that the gross profit share payment 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 million to $9 million in Q3 and $15 million to $20 million for the full second half of 2024.

We assume a stable foreign currency exchange rate for ex-U.S. pharmaceutical business. 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. 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 have included the results for the full quarter in our outlook.

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 multiyear, multiphase 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 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.

The onetime costs to achieve the savings with the near-term phase of the program are expected to be approximately $40 million and primarily includes 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 of revenue of $8 million to $10 million.

Before considering any nonrecurring costs that may result from our restructuring and other nonrecurring expenses, we expect costs and expenses in Q3 to decline approximately $3 million to approximately $153 million to $156 million without giving effect to the approximately $33 million of costs related to the assets conveyed to Labcorp. We expect to realize a gain net of transaction expenses of approximately $114 million 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 million and $185 million, with revenue from services between $125 million and $129 million, including $24 million to $25 million from the assets, which will be sold to Labcorp. Revenue from product sales of $40 million to $43 million and other revenue between $10 million and $14 million, inclusive of the Pfizer gross profit share, which is estimated to be between $7 million and $9 million.

We expect third quarter cost and expenses to be between $238 million and $245 million, excluding the nonrecurring expenses I previously mentioned. R&D expense is expected to increase, to be between $24 million and $28 million, with the range being dependent on certain CMC activities for our ModeX programs. And we expect depreciation and amortization expense to be approximately $24 million.

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

[Operator]

[Operator Instructions] And the first question will be from Maury Raycroft from Jefferies.

[Maurice Raycroft, analyst]

Congrats on the progress for the quarter. Maybe first one just on NGENLA. 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?

[Adam Logal, executive]

Yes. No, this is tied into the inventory adjustment that we talked about last quarter, Maury. So it's just the final pull-through of certain territories. That adjustment is 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.

[Maurice Raycroft, analyst]

And then is it possible to book and 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 plans for the additional pediatric indications?

[Adam Logal, executive]

So on the pediatric indications, so 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, they're still working with their team to formulate their strategy for the U.S. approval.

[Maurice Raycroft, analyst]

And then last question, and 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 to the closing?

[Elias Zerhouni, executive]

Yes. So right now, it's really focused heavily on the integration steps between the clients in Labcorp. So those are the main gating items. There's a couple of minor regulatory filings that just need to get cleared up, but all of the major hurdles are behind us, which is why we have pretty certain clarity, but this transaction will get closed late September, early October.

[Operator]

And the next question will be from Yale Jen from Laidlaw Company.

[Yale Jen, analyst]

My first one is that in terms of closing the Labcorp 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 to breakeven and cash breakeven and then we have a follow-up.

[Elias Zerhouni, executive]

Yes. So Yale, 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 will put us to a point where the business is breakeven to slightly profitable. So we only gave the initiatives that will -- we expect or we have in hand that we've -- that we'll 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.

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 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, analyst]

Congrats on that. And just one more question on the MDX-2001, which is the first part. Have you guys reviewed what the specific target for the [ tetra-factors ] on the antibody was 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 specific?

[Elias Zerhouni, executive]

Yes, I can do that. Elias here. Thanks 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. So it's a quadraspecific antibody that has for tumor targeting has 2 targets. One is TROP2 and the other one is c-MET. These are the 2 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 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 one, which we believe is going to be non-small-cell lung cancer, breast cancer, the solid tumors, pancreatic cancer, we don't know. 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 1 or maybe 2 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, the side effects. And 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 determined by the clinical.

[Yale Jen, analyst]

And maybe just to add one more here, which is, was there any timeline we can start to get some topline or initial readout?

[Elias Zerhouni, executive]

So typically, when you do an immuno-oncology trial, you have a first phase, which is safety. So we are escalating the dose. We hope that this will take about 6 months if everything goes well. And then we'll go into a more efficacy type trial with a cohort of patients, about 3 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 6 sites.

We have 2 sites right now, and we have 4 more; 2 are imminently going to get activated and 2 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 dosed, okay? So that's step one. And we don't know that at this time. Immuno-oncology is always a -- they're very powerful therapies, but they also have side effects we need to understand and manage.

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

[Yale Jen, analyst]

Congrats on the progress.

[Operator]

And the next question will be from Michael Petusky from Barrington Research.

[Michael Petusky, analyst]

So I guess first question. At the end of this year, it seems like a lot of things are sort of converging sort of going in the right direction. Presumably, you'll have approximately $240 million, just under $240 million coming in from the Labcorp. 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.

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 sort of unprecedented financial flexibility you guys will have going forward?

[Phillip Frost, executive]

Elias, do you want to kick us off and I can fill in?

[Elias Zerhouni, executive]

I'll talk about capital allocation in terms of R&D and BioReference. So when we look at BioReference, 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 is still very fragmented. And so definitely accelerate the growth in BioReference for increasing revenues.

The second is ModeX. I mean ModeX has a rich portfolio, and we're going to do 2 things. We're going to explore partnerships as we've done with Merck and BARDA and others are in the hopper. But because we have some capital, we can get better economics with a partner that we do the that capital being available. So for example, if you look at certain assets, you get a much higher inflection points 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.

So it's going to be 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.

I don't think we have enough of that, and it will not be hedging, it will 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 by very judicious and very limited capital allocation is you're not talking about hundreds of millions of dollars. But if you can advance the program to park a feasibility stage, then it really increases in value for potential strategic partners or other moves. I don't know if I'm making myself clear.

Now in terms of the other uses of capital, I'll let Adam comment on that.

[Adam Logal, executive]

Yes. So Mike, I think the other components, we announced $100 million 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 will 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 2 repurchase programs.

[Michael Petusky, analyst]

Is there -- Adam, if I could ask, is there any sort of targeted time frame on sort of achieving or executing most of the share repurchase or what -- and whatever notes you might decide to repurchase?

[Adam Logal, executive]

No, we haven't set a timetable to it, like no.

[Michael Petusky, analyst]

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

It hasn't really shown up in the numbers. I think we're about flat year-over-year for the first half versus first half of '23. I mean, is there anything anecdotal that you're getting back from sales in terms of this data that you guys are trying to argue, hello, this should matter to you guys? I mean, is there anything to say on that, that would be encouraging or does it just, or is this missionary and it takes a while?

[Elias Zerhouni, executive]

I don't know if Charles is online, Dr. Bishop.

[Phillip Frost, executive]

He is not.

[Elias Zerhouni, executive]

Okay. So let me take it. So when you look at the issue of growth for Rayaldee, the #1 request from nephrologists is does it have a good outcome impact. And that's the sign as delaying dialysis and delaying the onset of total renal failure.

Now one of the factors that drives that is when your hyperparathyroid 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 parathyroid hormone goes down, is Rayaldee.

We've shown that before. So it's not new. However, what we haven't shown and that's we -- 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 -- there're 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 Rayaldee? I don't think so, honestly. I think it's going to take time to sink in into the practice world.

[Michael Petusky, analyst]

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 Rayaldee 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 fit like that in terms of potentially looking at that as a source of capital allocation priority?

[Phillip Frost, executive]

I'll answer that. And 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. And if you come across one, please let us know.

[Operator]

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, executive]

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.

[Operator]

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