OPKO Health (NASDAQ:OPK) reported first-quarter financial results on Tuesday. The transcript from the company's first-quarter earnings call has been provided below.
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Summary
OPKO Health Inc reported first quarter 2026 revenue of $124.2 million, a decrease from $149.9 million in Q1 2025, with a consolidated operating loss of $51 million, improving from a $67.2 million loss in the previous year.
The company is advancing its Modex product development pipeline, including several clinical trials for oncology and immunology treatments, and anticipates multiple clinical and partnership milestones in 2026.
Collaboration with Regeneron and BARDA is progressing, with potential milestones exceeding $1 billion and significant funding for infectious disease programs, respectively.
The diagnostics business is focusing on its core regional operations, with a targeted strategy to achieve breakeven by mid-year and expand its 4Kscore test offering.
OPKO Health Inc maintains a strong cash position of $341 million to support ongoing operations and R&D investments, with plans for future revenue growth driven by its biopharmaceutical and diagnostics segments.
Full Transcript
OPERATOR
Good day and welcome to the OpcoHealth First Quarter 2026 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 one on your touchstone phone. To withdraw your question, please press Star then two. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs. Please go ahead.
Yvonne Briggs (Investor Relations)
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 Inc financial results for the first quarter of 2026. 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. 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, 2025. Furthermore, this conference call contains time sensitive information that is accurate only as of the date of the live broadcast, April 28, 2026. Except as required by law, OPCO undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this call. Regarding the format of today's call, Dr. Philip Frost, chairman and Chief Executive Officer, will provide opening remarks. Dr. Elias Sirhouny, Vice Chairman and President, will then provide an overview of OPKO's therapeutic segment as well as BioReference Health. After that, Adam Logel, OPKO's CFO, will review the company's first 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.
Philip Frost (Chairman and Chief Executive Officer)
Thank you for joining us today. During the first quarter we made meaningful progress with our strategic initiatives, with particular emphasis on advancing our MODEX product development pipeline. MODEX now has five programs in the clinic spanning vaccines, oncology and immunology, all with the potential to be first and best in class in their therapeutic areas. Days after the close of the first quarter, we dosed our first subjects in the phase 1 clinical trial of MDX2301, our BARDA funded multispecific antibody for the prevention of COVID in high risk populations. Shortly thereafter, we announced the dosing of the first patient in a phase 1 trial to evaluate MDX 2003, a tetra specific T cell engager in patients with relapsed or refractory B cell lymphoma. We also continue to advance our other oncology candidates in Clinical Development, MDx2001, a tetraspecific T cell engager targeting solid tumors, and MDx2004, a multispecific immune rejuvenator. Over the course of this year, we expect MODEX to achieve a number of clinical and partnership milestones as these programs progress and in the case of our EBV vaccine approach, later stage development with our partner Merck. Our collaboration with Regeneron is progressing well as we align their extensive antibody binder libraries with our multispecific engineering platform across various indications in metabolism, oncology and immunology. This collaboration is another example of strategic partnerships that are a good source of non dilutive capital to support our RD efforts. The potential total value of the regenerant collaboration exceeds $1 billion in milestones plus future royalties in our diagnostics business. Q1 reflects our second full quarter with the new BioReference footprint following our oncology divestiture. We're now centered on our core regional clinical laboratory operations in New York and New Jersey, our correctional health business and our national specialty urology testing franchise anchored by the 4K score test. We continue to streamline our infrastructure and cost base to achieve profitable growth from this segment. We closed the quarter with a solid cash balance. This reflects past asset sales, continued R and D support from our partners, and contributions from our international pharmaceutical operations. This financial strength enables us to fund our RD portfolio at a meaningful level and to return capital to shareholders through our stock repurchase program. With that overview, I'll turn the call over to Elias.
Elias Sirhouny (Vice Chairman and President)
Well, thank you Phil, and good afternoon everyone. Let me start with the biopharmaceutical side of our business because that's where we're making tremendous progress advancing our pipeline right now. As Dr. Frost said, we now have five assets in the clinic and expect an additional program for our in vivo CAR T cell platform to commence first in human clinical trials this year. So let me review our programs and provide updates on each of them. Our collaboration with Merck is focused on a vaccine against Epstein Barr virus that combines four Epstein-Barr Virus (EBV) antigens developed by MODEX with Merck's adjuvants. In the phase one trial, Merck enrolled over 200 subjects to evaluate safety, tolerability and immunogenicity, and various subgroup studies and analysis are underway to understand the responses in Epstein-Barr Virus (EBV) naive subjects and patients as young as 12 years of age, which will be important for future studies. So we expect Merck to have the data needed to inform a Phase two design by the end of this year, with initiation of a phase 2 clinical study anticipated next year. Subject to Merck's decisions and announcements now for MDX 2001, which is our lead immuno oncology candidate for solid tumors including head and neck, esophageal, pancreatic, lung and prostate cancers. MDX2001, as you know, is a tetra specific T cell engager directed at two tumor antigens, CMET and TROP 2 and 2T cell activators CD3 and CD28. The goal is to drive a deeper and more durable response by simultaneously recognizing heterogeneous tumor antigen expression and providing both CD3 and CD28 activators and enhancers to T cells, thereby enhancing activation and T cell survival. Enrollment of Phase one studies continuing into two parallel cohorts to support dose escalation and optimize the dosing regimen. We have dosed more than 30 patients so far across multiple tumor types and have reached dose levels approximately tenfold higher than the starting dose, all with acceptable safety. We plan to present phase 1a data at a conference in the second half of this year. In addition, phase 1b is expected to start later this year, focusing on the tumor types most likely to show signs of efficacy. We're also commencing work to enable subcutaneous formulations for our next program, MDX2004, which is our first in class multi specific immune rejuvenator that simultaneously engages CD3, CD28 and 41 BB to not only activate but also expand and sustain stem like and memory T cells in the immune system. Preclinical data has demonstrated that MDX 2004 expands stem T cells, increases the T cell activation and stimulates proliferation of CD8 and CD4 memory subsets and so these its potential as a pipeline in a product across cancers and chronic infections among the elderly and immune impaired subjects. MDX 2004 entered phase one in the third quarter of late last year and we're currently in the dose escalation stage in heavily pretreated cancer patients. The trial includes both PD1 naive patients and patients previously treated with PD1 inhibitors with the goal of determining whether immune rejuvenation can restore or prolong responses. Our objective this year is to complete Phase 1A, define an appropriate dose and schedule, and prepare for expansion into select tumor types and longer term into broader immune impairment indications. Now our newest molecule in the clinic is MDX 2003. It's our T3 specific T cell engager and expander targeting both CD19 and CD20 on B cells and CD3 and CD28 on T cells. The intent is to address tumor antigen heterogeneity and escape mechanisms, which we see with CD19 only or CD20 only approaches by maintaining activity even when 1B cell marker is lost while CD28CO stimulation supports sustained T cell function. We recently initiated a phase one trial in B cell lymphomas and leukemias in Australia and Israel, with additional sites to follow in parallel. We're evaluating the optimal path to explore autoimmune indications for MDX 2003, which has a potential to play a role in autoimmunity. In March, MODEX presented two posters at the ESMO Targeted Anti Cancer Therapies Congress 2026 in Paris, further highlighting the breadth of our oncology portfolio. One presentation profiled MDX 2004 describing the ongoing first in human trial in patients with advanced tumors and introducing the concept of immune rejuvenation as a differentiated approach to restoring antitumor immunity. The second was focused on MDX 2003 and showcased its potent preclinical activity across multiple B cell malignancy models and its potential relevance in autoimmunity. In addition to our own research, we're very pleased with the progress under our collaboration with regeneron, which, as Dr. Frost mentioned, combines their extensive library of clinically validated monoclonal antibody binders with our modular multispecific architecture across immunology, oncology and metabolic diseases. Together, the teams are focused on advancing four initial discovery programs using the MODEX platform to rapidly generate and optimize multi specific antibody candidates with the potential to expand into additional targets over time. Regeneron is responsible for funding preclinical clinical and commercial development of the selected assets, while OPCO is eligible for research development, regulatory and commercial milestones that could exceed $1 billion, as well as tiered royalties on global sales up to the low double digits. Now moving to infectious diseases, MDX2301 is the first MODEX multi specific antibody program to enter the clinic under our collaboration with BARDA. MDX2301 is a tetravalent bispecific antibody that targets distinct and conserved regions of the SARS CoV2 spike receptor binding domain and it is designed for broad coverage and long duration of protection because it really attacks two separate regions of the virus which prevents escape of the virus through mutations. The initial indications are prophylaxis in high risk immunocompromised populations who cannot be protected by immunization vaccination and used in post exposure outbreak settings with potential expansion into acute treatment of COVID and the treatment of long Covid. To date, remarkably, this multispecific antibody has demonstrated high potency against all known variants of SARS COV2V2 and continues to be effective against all circulating variants of the virus. We initiated the Phase 1 trial of MDX 2301 which is evaluating safety and tolerability across different routes of administration and dosing regimens in healthy volunteers and in adults at high risk for severe co occurring and the first dose cohort is completed and BARDA is funding the program including the clinical trial costs. BARDA is also supporting our Multi Specific Influenza program which targets conserved regions of hemagglutinin to enable broad coverage across influenza A and B strains. We're currently conducting pre IND work using challenge models to select the lead clinical candidate and we expect this program to move closer to the commencement of clinical trials with the potential for additional financial support from BARDA. To date, BARDA has committed over $100 million since the inception of these two programs. Now, over the past several years MODEX has also built a multimodal in vivo CAR T and gene delivery platform that we believe is highly differentiated versus traditional ex vivo CAR T approaches because it combines our unique multi specific technology with proprietary in vivo CAR technologies. Using lipid nanoparticles conjugated with cell specific multi specific antibodies on the surface, we can deliver MRNA or DNA payloads encoding cars directly to specific immune cell subset not only just T cells but also B cells or NK cells to generate functional CAR T cells in vivo at lower effective doses. Preclinical data has been obtained in humanized mice and non human primates and a presentation of this work will be made at the ASGCT meeting in Boston next month and we believe this technology offers several potential advantages. It is off the shelf, can be redosed and leverages our multi specific antibodies for cell specific targeting and built in activation via CD3 CD28. It also uses site specific antibody conjugation and proprietary lipids to support manufacturability at scale and reduce off target delivery to the liver. In non human primate studies we have shown proof of concept for in vivo CAR T generation, deep B cell depletion in blood and tissues and a favorable tolerability profile. These effects were achieved at doses that were a fraction of those reported for completing platforms for competing platforms. Sorry, we're now in IND enabling studies for our lead CD19 targeted in vivo CAR T program and expect entry into the clinic by the end of this year or early 2027. Now turning to our endocrine and metabolic programs, we continue to advance our subcutaneous injection formulation of UBCO. ADA 006 for the treatment of MASH 88006 is an analog of the natural GLP1 glucagon hormone occipital modulin and we're planning a first in human single ascending dose and multiple ascending dose phase 12 a clinical study with data expected by the second half of 2027. The findings will be used to guide the further development of our oral oxyntomodulin in partnership with Entera Bio. We also recently expanded our relationship with Entera to include a third joint program for a first in class long acting PTH tablets for patients with hypoparathyroidism and this program combines opsco's proprietary long acting PTH variants, Bonanteros and Tab technology and we in NTERA each hold a 50% ownership interest in this program and we will share development costs equally. Presuming favorable PK PD data, we're targeting an IND filing later this year. Now our international pharmaceutical operations continue to experience solid growth during Q1 with healthy contributions to the overall business. For the quarter, global pharmaceutical product sales grew about 9% versus the prior year due to favorable demand trends as well as foreign currency tailwinds. Our partner Pfizer continues its global commercial expansion of our long acting growth hormone product enGENE. Now, as a final topic for today, I'd like to turn attention to our diagnostics business following the sale of BioReference's oncology assets to LabCorp in 2025. BioReference is now a regionally focused clinical laboratory with a national specialty testing franchise highlighting a proprietary 4K score test. We operate with a more efficient footprint with an expanding menu of higher margin services. In the first quarter of 2026, BioReference's streamlined business showed a volume increase of more than 3% in the number of accessions per day compared to the previous quarter. This performance was reflected in particularly strong volume in our SQHC and corrections business lines, plus momentum in our higher margin services. Margins also saw improvement versus Q4 primarily driven by the aforementioned volume increase and continued efficiency gains, including an additional 4% reduction in headcount within diagnostics. 4K score continues to be an important part of our test offering and the recent label update which removes the digital rectal examination requirement, positions us to broaden adoption beyond urologists and gradually build a presence in primary care and we see 4Kscore as a unique high value asset with the potential to deliver significant revenue and profitability as we broaden payer coverage and continue educating both urologists and primary care physicians about its clinical utility. With our geographically focused footprint, right size, workforce, expanding menu and proprietary 4K score tests, we are seeing nice performance improvements at BioReference and we believe that these continued efforts achieve breakeven in the business will help achieve breakeven in the business by the middle middle of the year. In summary, our progress with the MODEX pipeline along with our partnerships and collaborations, international pharmaceutical portfolio and restructured diagnostics business have really transformed NOCO into UPCO into a more targeted innovation led organization with multiple key catalysts coming up later this year. So with that I'll turn the call over to Adam to review our financial results and outlook.
Adam Logel (Chief Financial Officer)
Adam thank you Elliot. We ended the quarter with a strong cash position with over $341 million in cash, cash equivalents and restricted cash which is more than sufficient to fund our ongoing operating needs and development plans. While we also are returning capital to our shareholders, let's start with the financial performance of our diagnostics business. The financial results for the first quarter met our expectations and and we are encouraged by the progress the team has made sequentially improving the operating loss by 5.3 million and by 11 million over the Q1 of last year. We have restructured this business and remain on track to achieve break even as measured by results from operations before non cash expenses. By the middle of the year. Revenue for Q1 2026 was $72.2 million, including $6.5 million from our 4K score test. Revenue in Q1 2025 was $102.8 million with the year over year decline expected due to the oncology customer accounts included in the LabCorp transaction that closed in September of 2025. Revenue from our retained business slightly declined versus the prior year, principally due to test mix changes as we shifted some unprofitable but higher price esoteric testing to our strategic partners. Along with snowstorms that impacted the New York New Jersey market which we mentioned in our February call. Total costs and expenses were $85.1 million, down from $126.8 million last year, reflecting the September 2025 transaction closing as well as the continued efforts to rationalize our cost structure to align with our focused geographic footprint and testing offerings. Our diagnostic operating loss was $13 million compared to $23.9 million in Q1 2025. Depreciation and amortization for this segment came in at $3.9 million, down from 5.7 million in 2020. Turning to our pharmaceutical business, revenue was $52 million in Q1 compared to 47.1 million in the prior year. Revenue from product sales increased to $38 million, up from 34.8 million, reflecting higher sales volume in our international operations and foreign exchange tailwinds during the quarter. As we continue to focus on on the profitability of rialdi, the gross to net improvements we began to realize last year have resulted in meaningful positive cash flow from operations in 2026 while maintaining overall revenue levels. Rayaldee contributed $6.3 million during Q1 of both 2026 and 2025, reflecting slightly improved gross to net offset by a slight decline in volume. Our Pfizer profit share was $6.4 million for the quarter, reflecting a 42% increase to 2025's $4.5 million. Pfizer's progress on the global commercialization of enGENE continues to show consistent growth. The 2025 profit share was negatively impacted by certain gross to net and inventory revaluations that did not recur in 2026. In addition, BARDA funding was $4 million in the first quarter of 2026 compared to $7 million a year ago, reflecting the start of our Covid clinical program under this collaboration. While the 2025 period included higher levels of CMC activities for our infectious disease programs. As a result, IP transfer and other revenue was $14 million compared to 2025 $12.3 million. Costs and expenses for our pharmaceutical business were $81.7 million, similar to 2025's $81.9 million, reflecting a favorable sales mix of higher margin products. While we continue to meaningfully invest in our R and D programs, R and D for Q1 2026 totaled $28.8 million, down slightly from $30.2 million in the 2025 quarter due to lower CMC related activities partially offset by increased levels of our early stage clinical trials. As a result, our pharmaceutical operating loss was $30 million in Q1 2026 compared to last year's operating loss of $34.8 million. Depreciation and amortization expense was $18.3 million, which was slightly higher than 17.8 million from last year. For our consolidated financial results, Total revenues for Q1 2026 were $124.2 million compared to 149.9 million in the first quarter of 2025. Consolidated operating loss for Q1 2026 was $51 million, improved from 2025 $67.2 million loss. Our net loss for Q1 2026 was 54.8 million or $0.07 per share, which improved from 2025's net loss of 67.6 million or $0.10 per share. Looking forward to the outlook for our second quarter of 2320, we expect total revenue to be between $127 to $132 million, with revenue of services from 72 to $76 million, with the range reflecting several assumptions around testing volumes and reimbursement pricing. We expect pharmaceutical product revenue of 38 to 42 million dollars and we expect IP and other revenue to be between 15 to 19 million dollars, including the Pfizer profit share of 6 to 8 million dollars. Total costs and expenses for Q2 are expected to come in between 180 million and 190 million dollars, excluding the earnout anticipated from LabCorp related to the closing of our second transaction, as well as any one time restructuring costs. With our expanding investments in R and D, we expect R and D to become between 32 and 38 million dollars, partially offset by 5 to 7 million dollars in BARDA funding, and we expect depreciation and amortization expense of approximately $24 million. We're affirming our full year guidance that we introduced when we reported our Q4 results which are included in our earnings release and as of the end of Q1 we add approximately $108 million authorized to repurchase shares of our common stock. With that we have concluded our prepared remarks and we'll open the call for questions.
OPERATOR
Thank you. We will now begin the question and answer session. To ask a question you may press Star then one on your Touchstone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time a question has been addressed and you would like to withdraw your question, please press Star. Then two analysts are requested to limit one question and one follow up. At this time we will pause momentarily to assemble our roster. The first question comes from Maury Raycroft with Jeffries. Please go ahead.
Maury Raycroft (Equity Analyst)
Thanks for taking my questions. Starting off I was going to ask 1 on 4K score and wondering if you can comment on the proportion of payer policies that have been updated to reflect your new FDA label and what else needs to be done on this front? And can you talk about what you're doing to get more primary care doctors on board with the diagnostic and are there education efforts underway?
Adam Logel (Chief Financial Officer)
There's. Yes. I'll start off, Maurice. So on the payer policies, we are continuing to work across the board, starting with Medicare, to update their coverage determination or more accurately reflect the FDA label. But beyond that, we are engaging with payers. I'll say there's not many payers that had a requirement for digital rectal exam (DRE) on the, the commercial setting or outside of Medicare. So we are continuing to look at that from an overall perspective. So as it relates to going into the primary care market, we are waiting for that local coverage determination (LCD) to get updated before we more aggressively go into the primary care market. And we would expect that to happen in the middle of this year.
Maury Raycroft (Equity Analyst)
Got it. Okay. And anything more you can say on how you think about growth expectations for the base business and what 4K score, how 4K score will contribute to that growth over the course of the year?
Adam Logel (Chief Financial Officer)
Yeah, so I think you'll see in the applied way that the math works between the first half and second half, you'll see some growth coming in the back half of the year driven by some of the expectations we have around 4K and just generally a more focused footprint on BioReference's, New York, New Jersey businesses. So 4K grew significantly last year. The comps this year were a little bit more challenging. So we didn't see the same level of growth that we saw last year. But we would have an expectation that we, we should achieve double digit growth on 4Kscore volumes this year, which will lead to us, you know, getting into that range of 300 to $312 million for the, for the total business of bioreference.
Maury Raycroft (Equity Analyst)
Got it. Okay, that's helpful. And maybe one other question on the enGENE and Genotropin profit chair. Wondering if you can comment more on just your latest communications with Pfizer related to forecasts here. And can you clarify whether you're observing commercial impact from the Dear Doctor Letter that Pfizer sent to prescribers over the course of summer last year? And if Pfizer is doing more on that front to increase switching from genotropin to Engenla?
Adam Logel (Chief Financial Officer)
Yeah, so we have continued to see pretty good growth for enGENE is part of the total franchise between Genotropin and Angela. So we think Pfizer's been quite aggressive in seeing that conversion pull through and continue to maintain their share or grow their share beyond some of the other long actings in the growth hormone space, both here in the US but also globally. But we've been, we've Seen pretty significant growth, you know, quarter over quarter and year over year for the in generalist share we still think that Pfizer owns, you know, around a third of the global long acting market. The conversions are happening, you know, at a consistent pace, not as aggressively as we previously had expected, but certainly ramping upwards. And as it relates to Pfizer sharing, their outlooks are for forecast. They don't necessarily give us anything forward looking as it relates to how we should expect the entire franchise to grow. I think I covered all the questions. Maury. Yep.
Maury Raycroft (Equity Analyst)
Yeah, that was helpful. Thanks for taking my questions.
OPERATOR
Thank you. The next question comes from Brian Chang with JP Morgan.
Brian Chang (Equity Analyst)
Hey guys, thanks for taking our question this afternoon. Maybe just first I want to know a little bit more about your expectations for your tech TCE B cell lymphoma trial. Can you walk through what you'll be looking for from that study? What will be good response A to C early on? And do you have a sense of what would be a good line of setting for this specific mechanism? And we have a follow up. Thank you.
Elias Sirhouny (Vice Chairman and President)
I think Gary, who's leading the, the modax can answer that. That's a great question actually. That's, you know, good to talk about Gary.
Gary
Yeah, thanks Elias. Well, you know, obviously the first order of business is to show acceptable toxicity and that's where the early phase one data becomes important. We don't expect to see anything different from other candidates that have gone forward, but we need to get through that first once we go therapeutic efficacy, what we're particularly interested in is looking at the failures to the CD20 multi specifics or bispecifics and for example molecules like Glofitamab for which resistance becomes evident quite frequently. And so we think as a starting indication this will be a population where we can essentially salvage therapeutic response. I should also. And then eventually that gives us the opportunity to move up in terms of the actual order of and priority of treatment. The other indication that we shouldn't forget is that by depleting B cells with CD19 and CD20, this molecule has an opportunity to be used in autoimmunity. There are opportunities, for example in lupus and other autoimmune B cell diseases where we will look for its ability to reduce the inflammatory reaction and those will come after we get the initial safety data but not much delayed after that. So there are multiple indications that we think we can pursue. Got it. That's very helpful. And maybe just one more on the Merck partnership on the UV vacc. Any updates in terms of data disclosure perhaps later this year. And also, can you give us a better sense about the next step for that program? Thank you, Yeah. Ellis, you want me to cover that as well? Yes, please. Yeah. So, as you know, we began the Phase one study a while ago with two different adjuvants where we compared their efficacy one to another, both in naive individuals, but and also in virally infected or formerly virally infected individuals. The reason we're looking at both populations is that ultimately the vaccine is intended for patients who are EBV naive. But another consideration we have to watch out for is that the vaccine doesn't have any untoward effects on the people who are EBV positive. The vaccine trial has gone smoothly. Enrollment has been very, you know, facile, and no surprises. We are not disappointed at all in terms of the immunogenicity that we're seeing. But what we are trying to do in anticipation, anticipation of Phase two is to get a better read on the EBV negative patients who are a much smaller proportion of the overall population. So we have been filling in those blanks with the idea that we will then down select one of the two adjuvants and simplify the formulations for Phase two. So I do think that information will be available certainly by the end of the year. And we won't disclose any trial results, obviously, until all the data are in. But I think you will hear about the evolving plans for Phase two and then what the rationale and what the data is behind that. And I just don't want to get too far in front of it because these are really decisions that Mark will make. And so we don't want to do anything that steps outside of the guidelines they normally use for advancing their products. Thanks for the color and looking forward to it.
Brian Chang (Equity Analyst)
Thank you. Sure.
OPERATOR
The next question comes from Yi Chen with Etsy Wainwright. Please go ahead.
Yi Chen (Equity Analyst)
Thank you for taking my questions. My first question is the reported first quarter revenue is just a little bit below your previous guidance. So can you talk about which segment in revenue sort of underperformed a little bit in the first quarter? And how should we look at the second quarter revenue guidance?
Adam Logel (Chief Financial Officer)
Yeah. Where the majority of that shortfall came was actually related to our other revenue and IP revenue. So we had planned activities to do some additional Chemistry, Manufacturing, and Controls (CMC) activities under our BARDA contract, and those got delayed until later this year. So that was about almost $6 million of the shortfall, which is what took us below where we had previously guided. So from a net bottom line perspective, no Impact because R and D came in lower than than we had forecasted along with the associated revenue that would have been recorded. Hopefully that makes sense.
Yi Chen (Equity Analyst)
Got it, got it. Thank you. And also with respect to the commercial plan for MDX 2301 for prevention of COVID 19, do you have any plan to commercialize it just by yourself in the future or is it going to
Elias Sirhouny (Vice Chairman and President)
be a contract with the government? Well, I'll start and let Gary also comment. I mean from our point of view, depending upon the results we observed, I mean we have two markers that really need such a molecule given its ability to resist mutations or so far has been, you know, an antibody that has shown activity against all known variants. So we think that the immunocompromised population would be cancer patients or patients under therapies that are immunosuppressive, who cannot really get vaccinated or mount an immune response. Those would be the primary population that would really benefit from such a molecule and that's about 30 million people in the US in terms of developing it. We definitely are looking for a partner to co develop or, or find a way because I think it's going to require that sort of expertise and experience in the marketplace around the immunocompromised populations, whether it be cancer centers or other nursing homes and all that. So yes, the question is what population immunocompromised doing it on our own? No, probably with a partner that can have add to our clinical development process. Gary, am I missing anything?
Gary
Well, yes. Thanks Elias. The only thing I would add is that just to be clear, there can be two different partners or two different sources of revenue. So clearly if this gets to the point of being approved, this is a product that Barda would want to stockpile. And so yes, there would be some, assuming we get to that point, some kind of a contract with the government to provide material to the stockpile. I think both Barda and we feel that the best way of addressing, you know, future threats from COVID is to also make sure it's out there and available for those who need it. And so that's why Elias is saying we think there's a great unmet need in people who don't respond to vaccines, people who have underlying cancers or elderly who can't mount effective immune responses. And so yes, we one way or another want to address that market. And I think that at this point it's probably just too early to say what commercial partner or what commercial, you know, infrastructure we might choose to pursue. I think our eye is mostly on the next steps of getting the approvals for end licensure from fda. That's kind of a near term.
Yi Chen (Equity Analyst)
Thank you.
OPERATOR
The next question comes from Kevin Dejida with Lalmang Talman. Please go ahead.
Kevin Dejida (Equity Analyst)
Hey, good afternoon. Thanks everybody, for taking our questions. My questions are first, on the in Vivo CAR T program, we've seen a lot, continue to see a lot of activity on the MA front in the space. Can you just remind us maybe of two things? One, you know, how you see the differentiation of your in vivo CAR T platform from some of the others that are just slightly more advanced in early stage clinical development. And then just to, you know, how you see, you know, key milestones that you need to execute against to bring that program into the clinic late in
Elias Sirhouny (Vice Chairman and President)
26 or early in 27. I'll start and Gary, let me start and then you can, you know, cover what I'm missing. So actually, the in vivo CAR T program is not a new program. This is something we have been doing for several years. Thinking about it from, you know, the point of view of differentiation. What differentiation do we talk about? Number one, as you know, in the lipid nanoparticles by themselves do not target specific cells. And so we thought that the number one differentiation would be targeting of the lipid nanoparticle better than the competition does. And in this case, we knew that we could use our multispecific platform to target different types of cells in different ways by conjugating an antibody on top of the lnp, but conjugating in a covalent way so it's attached, it doesn't fall away. And then when that's done, it goes to the proper target cells in a proportion that is favorable to the activity of the CAR T technology. So that leads to A, a differentiation, B, the ability to multiply the number of targets you can and number of cells you can number a type of cells you can address. But also it reduces the need for higher doses because you don't have a loss of LNPs in areas where there is no targeting. So that's number one. So differentiation one is unique technology combination of LNPs that we actually improved ourselves and in a proprietary way with lipids that are really designed for what we do, plus chemical conjugation that is unique in the business. And so having the multi specifics pull the LNP gave us potential. Second is we use what we know best, which is a targeting and activation, which also leads us to actually have effects at 5 to 10 times lower doses than the competition, which obviously improves the therapeutic window. And so that's the Second one, the third one is the fact that we found ways of having cargoes that are both RNA and DNA and that is very promising because others haven't been able to achieve that. And last but not least, because we have a multispecific technology, we can create chimeric antigens that are also bispecific or tri specific themselves. So that gives you a sense. Now the other question, key milestones. We've already completed all the non human primate studies. We're in the middle of creating the, the CMC essentially which will be finished in, in terms of drug product within the next few months, three, four months, five months maybe, and then preparing in fact the launch of the first trial, human trial, you know, before the end of this year. We hope those are the milestones for us get into the clinic and show, show both safety and efficacy, what we believe is going to be a more effective way of truly deploying this very promising technology. I stop here, Gary, did I miss anything that you want to add, call or to.
Gary
I think you covered it very well, Elias. The only minor things I would add are that we, while our lead program is targeted towards in vivo CAR T cells, we've also learned how to use other antibodies to target genes into other cell types so that we can target B cells, we can target NK cells. And so we see this really as the leading edge of a very exciting broad platform that builds on our knowledge of the multispecific platforms. So and the one other application that Elias didn't mention is that obviously it can be used for gene correction using CRISPR recombinases to modulate or make sure the DNA is permanently kept or in other cases, transiently expressed. So it's just a very fertile area. And the only other thing I would emphasize, because I think we slide it but didn't come out and say it, is that we're planning to do the initial studies using the IIT mechanism in China, which allows us to go faster, allows us to, for us to be more efficient and for us to also do it with lower cost. So it will accelerate our efforts there. And that's where when Elias was talking about the preclinical package. We also have some safety data that we will be providing the investigators who will be conducting studies. But everything is on track and we're very excited about it because it's a whole new world in terms of both antibodies and gene delivery.
Kevin Dejida (Equity Analyst)
Thank you for all that view. That's all for our questions today. Thank you so much.
OPERATOR
The next question comes from Yale, Jen with laidlaw and co. Please go ahead.
Yale Jen
Good afternoon and thanks for taking the questions. Just we have two here. The first one is in terms based on the guidance for the 2026, we believe the diagnostic on the business seems having a continuous growth quarter over quarter in the patent. So you mentioned about the 4Kscore. Would that be any other aspect or factors also could drive the revenue growth on that operation. Can we have a follow up?
Adam Logel (Chief Financial Officer)
Yeah. So Yale, the main drivers beyond 4k is really the first full year of the focus on the New York, New Jersey market. So the commercial team has been been very aggressive in identifying new opportunities and growth opportunities in those markets. It's all still within the typical clinical and women's health portions of the business. There are some adjacent lines that we continue to explore and work towards, but it is core accounts being one in the markets and we have a very rich and deep pipeline that teams executing against. Okay, great. And maybe just one question for 2001.
Yale Jen
Given that crop one is one of the targets. Just curious, at this stage is the triple negative breast cancer one of the targets? How should we think about the next stage in terms of the target selection? Tumor has tum time selection and development as well. Yeah. So as you know we're doing trials in patients who haven't or not responding to other tumors. Triple negative breast cancer also has high expression of TROP2 and CMAT. So it is part of our list of 14 cancers that could be responsive. But we're going to focus on the ones that show that have shown, you know, promising responses. But we haven't had a lot of triple negatives in our population so far. And so we hope to have them and eventually grow that population when we get into the Phase 1B, you know, the next phase. We also trying to enrich the population right now that we are near or at the right regimen and dose. So that's certainly a tumor that we'd like to have more of in our samples. But it is theoretically possible to have an effect on triple negative breast cancer. And maybe just to refresh my memory when we should anticipate the next data readout for 2001.
Elias Sirhouny (Vice Chairman and President)
Well, like I said, we're finishing the dose escalation and the regimen and you know, how do you do this when you do immuno oncology? As you know there's not a one size fits all protocol. There's step dosing that you use or you don't use steroids and then at what level? You know, you really do the interval one week. Also we are developing because we're very encouraged by what we see with our iv. We're now developing the liquid formulation so we can use sub Q delivery, which would be easier on the patients. And so we're exploring all of that. And obviously once we finish this, towards the third quarter, beginning of fourth quarter, we will have basically the plans for the Phase 1B pretty much in place by then. So at the end of the third quarter, beginning of fourth quarter, will be able to complete this current phase. Okay, great. That's very helpful and congrats on all the progress. Thank you.
OPERATOR
The next question comes from Edward Tantoff with Piper Sandler. Please go ahead. Great.
Edward Tantoff (Equity Analyst)
Thank you so much and excited about everything going on at OpCo. Looking forward to the in vivo data at ASTCT and 2001 data in the second half. One quick question. Did you say you would run the phase one study for in vivo in China and is that with a partner or are you partnering with a specific university there?
Elias Sirhouny (Vice Chairman and President)
Thanks. I'm sorry, I couldn't hear. Which product are you talking about for in vivo? The in vivo Carti.
Edward Tantoff (Equity Analyst)
Car. Chi, I think he's referring to.
Elias Sirhouny (Vice Chairman and President)
Right. Yeah. So, you know, we're. We're absolutely. We have a team actually right now they're interviewing the clinical sites and with a partner, local partner. And so I don't know at this point who will, you know. One or two sites, actually there are two sites, are very interested in participating. So we're basically doing due diligence on that right now. I can't tell you which site and when, but they're very, very anxious to really participate in this trial, given the uniqueness of this particular platform. Very neat. And when it comes to the immune rejuvenator, I appreciate it's still early, but what do you see as the regulatory path here? Is this something that you'd have to use in combination with other IO agents? And if so, does it make sense to partner this? Yeah, so this is a great question, as always. So we have actually two arms in our phase one as we described. There's a PD1 naive population and a PD1 exposed population or prior. Prior exposure to PD1. Now, a lot of people, when they look at this molecule, they, you know, the most common question, we say, oh, you don't have a. A cancer target? Well, PD1 also doesn't have a cancer target. It's a checkpoint inhibitor. The difference is that 2004 is an accelerator. It really enhances the response. It does not unblock the response. And when you just unblock Obviously, you may be unblocking very exhausted T cells. And so that's why we came up with this concept of rejuvenation. So think of it as basically a keytruda or an opdivo of a different kind, which will be combined obviously with other therapies at some point. But we have to show also to the FDA that monotherapy also has an effect. And that's what we're doing right now. It's a monotherapy trial for patients that are either naive to PD1 or have been exposed to PD1 but have progressed. I hope that helps you very much so. Thanks, Elias.
Edward Tantoff (Equity Analyst)
And then lastly, did I hear correctly that the plan was to advance subq uxantimodulin before advancing the oral formulation? In other words, sort of seeing what you learn from Sub Q first and then taking the oral into the clinic with Entera technology. Thanks. That is, you know, Dr. Hsiao runs the program and that is exactly what is happening. We need to understand better with the Phase 1, 2a, the behavior of the drug in an injectable format. So then once we fix that range, then you can really do the implementation of the oral because then you know what to target in terms of PK, in terms of area under the curve and CMax and side effects and so on. So we decided, and Dr. Shah decided it was better to get that information first instead of having many, many different approaches and dosing with the oral. So we think it would simplify, in fact, the path to oral. Great, that's super helpful. Thanks guys. Thank you.
OPERATOR
The next question comes from the line of Michael Patowski with Barrington Research.
Michael Patowski
Hey, good evening. So I think, Adam, I think you referred to, you know, in terms of the diagnostic business, you know, one of the drivers in the second half would be opportunities that that team is pursuing and, you know, sort of focused way in New York, New Jersey. Do you guys have line of sight of, you know, new business pieces that, you know, maybe starting mid year or like, like are there data points that you guys have put together or is essentially, hey, at this point these guys are sort of getting after it. Thanks.
Adam Logel (Chief Financial Officer)
So thanks for the question, Mike. So you're right. So the team is pretty mature in a lot of the onboarding of the accounts that are required to hit the numbers. And we feel confident we didn't change our full year outlook for the quarter we show or for the year we showed quarter over quarter growth. Some of that growth is coming from 4k, but a lot of it's coming from the traditional business that we have a very clear line of sight to.
Michael Patowski
Okay, great. And then just sort of sticking with the same segment. I think you guys referred to that there was a little bit of a headcount reduction I think you were talking about in Q1 in that business as you sort of look out, are there you know, cost and expense reduction initiatives that you, you know, would anticipate throughout the remainder of the year? Thanks.
Adam Logel (Chief Financial Officer)
Yeah. Elias mentioned the 4% headcount reduction that happened in the first, first quarter of this year. We, unlike prior years where we had, you know, major cost out initiatives that we executed, executed again. So a lot of this year is really turning into operating efficiency, so ensuring that we've got the right counts of people doing the right things. But there's no significant cost out plan to achieve the results. It's continuing achieving the operating efficiency that we're targeting. And I think the quarterly or sequential improvement, we'll continue to show that.
Michael Patowski
All right, great. Very good. Thank you.
OPERATOR
Thank you. This concludes a question and answer session. I would like to turn the conference back over to Dr. Frosh for any closing remarks.
Philip Frost (Chairman and Chief Executive Officer)
I want to thank everybody for participating and for the good questions that we've been to answer. We look forward to meeting with you again to discuss the results of the next quarter. good evening.
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