OPKO Health Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 6, 2023

There are 11 speakers on the call.

Operator

Hello, and welcome to the OpcoHealth Third Quarter 2023 Financial Results Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would like now to turn the conference over to Yvonne Briggs.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss Opco Health's financial results for the Q3 of 2023. I'd like to remind you that any statements made During this call by management, other than statements of historical fact, will be considered forward looking and as such will be subject to risks and uncertainties that can materially affect the company's expected results.

Speaker 1

Those forward looking statements include, without limitation, the various risks described in the company's SEC filings, including the annual report on Form 10 ks for the year ended December 31, 2022 and its subsequently filed SEC reports. This conference call contains time sensitive information that is accurate only as of the date of the live broadcast, November 6, 2023. 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. Before we begin, let me review the format for today's call. Doctor.

Speaker 1

Philip Frost, Chairman and Chief Executive Officer, will open the call. Doctor. Elias Zerhouni, Vice Chairman and President of OpCo, will then provide an overview of OpCo's Pharmaceutical business as well as BioReference Health. After that, Adam Logel, OpCo's CFO, will review the company's Q3 financial results and then we'll open up the call to questions. Now I'd like to turn the call over to Doctor.

Speaker 1

Frost.

Speaker 2

Good afternoon, and thank you for joining us today. The 3rd quarter was quite active at OpCo with several key accomplishments. In September, we announced that MODEX was Order the contract from the Biomedical Advanced Research and Development Authority, known as BARDA, to develop novel, multispecific antibodies The BARDA contract provides $59,000,000 of initial Funding for the development of multispecific antibodies against known variants of SARS CoV-two and another $109,000,000 And funding may be available to develop multispecific antibodies targeting other viral antigens, pathogens that is, such as influenza. This non dilutive funding provides MODEX with significant financial support to advance its extremely promising pipeline With the potential to provide benefits for patients worldwide. This BARDA award represents a second major collaboration for Modex in 2023 and its further validation of its differentiated and valuable technology platform.

Speaker 2

You may recall that earlier this year, MODEX entered into an exclusive worldwide license and collaboration agreement with Merck To develop its nanoparticle vaccine candidate for Epstein Barr virus. As for angenla, our once weekly

Speaker 3

injectable growth hormone therapy,

Speaker 2

it is now approved in growth hormone therapy. It is now approved in over 48 countries, including the U. S. As we announced in June. Pfizer, our global commercial partner, launched Ingenla in the U.

Speaker 2

S. In August. In addition to launches today in over 23 major Including Japan, Germany, the United Kingdom and all other priority global markets. We expect to see a material ramp up in sales for an angendla as Pfizer increases its market penetration globally. At our Opco Biologics unit in Israel, where Ingenla was developed, work has continued on other long acting peptides utilizing new 1, GLP-two to treat short bowel syndrome is being developed into a once daily oral form jointly with Entera, whose oral peptide delivery system containing parathyroid hormone recently successfully completed a Phase II trial.

Speaker 2

We're also considering working with Entera on one of our oxintomodulin peptides for weight loss. Our profitable Opco Ibero America unit continues to perform well as does Finetec, Our small specialty API company in Israel. AirGen, our pharmaceutical development and manufacturing company in Waterford, Ireland Is also doing well and is about to embark on a growth program. At BioReference Health, our cost cutting initiatives continue As we are focused on returning this segment to profitability in the near term. In addition, we are working to increase revenue by enhancing our test menu offering and expanding our customer base.

Speaker 2

With that overview, I'll turn the call over to Elias to provide Further discussion and commentary on our Pharmaceutical and Diagnostic businesses. Elias?

Speaker 4

Thank you, Phil, and good afternoon, everyone. As Phil said, the Q3 has been quite busy for both the Pharmaceutical and Diagnostics segments of OPCO Health. As Phil mentioned, we were delighted to announce the significant contract awarded to MODEX Therapeutics by the Biomedical Advanced Research and Development Authority, BARDA. You should know that BARDA is part of the Administration for Strategic Preparedness and Response at the U. S.

Speaker 4

Department of Health and Human Services, And this funding is a part of Project NextGen, which is dedicated to advancing innovative vaccine and therapeutic programs Against COVID-nineteen. The contract includes an initial $59,000,000 to enable research, Development and clinical evaluation through a Phase 1 study of potent novel MODEX multispecific antibodies against Non variants of SARS CoV-two, which remain a persistent threat for the millions of immunocompromised patients We may not develop sufficient immunity after vaccination and will need that support, if you will, for treatment and prevention of COVID-nineteen. Our proprietary mSTAR multispecific antibodies also Reduce the possibility of viral resistance, which has made previous monospecific antibodies ineffective over time. MSTAR is a flexible plug and play platform able to incorporate up to 6 independent antibody binding sites into a single molecule. And this capability dramatically expands the prevention and therapeutic potential of antibodies against Many viral diseases while enabling rapid responses to prevent or treat emerging infections and Based upon the achievement of certain milestones, additional funding up $109,000,000 may be available from BARDA to develop other multi specific antibodies targeting other viral pathogens such as influenza.

Speaker 4

And as part of the research program, gene based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors To supplement the body's natural protein production processes, the BARDA contract, as Phil mentioned, came about 6 months After the announcement of our collaboration with Merck to develop MDX-two thousand two hundred and one, our Epstein Barr virus multivalent Nanoparticle vaccine. We're pleased to have secured these 2 major strategic relationships to date And believe this achievement further validates MODX innovative multi targeting approaches increasing the interest of our proprietary technology. As a quick overview, our EBV vaccine program with Merck leverages MODEC's nanoparticle based vaccine platform, Enabling simultaneous immunization against 4 major EBV proteins. This multivalent approach Holds potential to protect against infection by this virus, which affects up to 95% of the global adult population during their lifetime. Importantly, over 200,000 cases of related cancers per year And multiple sclerosis are associated with infection by this virus.

Speaker 4

And we're now working with our partner Merck on IND enabling studies, which In addition, our antiviral multispecific antibodies program Focus on the treatment and prevention of HIV is progressing. In partnership with the NIH, our 1st generation candidate has been evaluated in the Phase I trial and clinical data will be reported in the near future. We have also developed next generation candidates for long acting HIV prevention and treatment That offer up to a 10 fold improvement in potency and breadth of antiviral activity against the majority of globally circulating HIV strains. This is an important program as there are currently no vaccines or antibodies that can provide long acting protection and treatment for patients We'll require treatment options beyond small molecule based therapies. In parallel, we have Also advanced our immuno oncology programs focused on hard to treat solid tumors as well as leukemia and lymphoma.

Speaker 4

Our multi specific antibody candidates are designed to optimize T cell function while preventing tumor antigen escape. These programs are now in the final IND enabling preclinical stage with the expectation that at least one program will enter the clinic in 2024. I also would like to reiterate Phil's comments about Engela. We're delighted with the continuing momentum of Pfizer's Global launches of the long acting growth hormone treatment, including the U. S.

Speaker 4

In August, and Adam will provide further detail on the financials, And we look forward to keeping you updated on the progress here. So now let me turn to RAYALDEE. Our treatment for secondary hyperparathyroidism or SHPT in adults with Stage 3 or 4 chronic kidney disease or CKD and low vitamin D levels. Sales increased over the prior year quarter as the number of prescriptions continue to grow. More importantly, recently, our team presented several posters Highlighting favorable RAYALDEE clinical data at the American Society of Nephrology Kidney Week, one poster reported late breaking clinical data Indicating that early sustained and effective treatment of secondary hyperparathyroidism with RAYALDEE Another poster presented data demonstrating that effective control of SHPT was achieved with RAYALDEE in both Randomized clinical trials and in a real world clinical evidence trial supporting early initiation of HSPT Treatment with RAYALDEE to delay disease progression.

Speaker 4

In addition, a Phase 3 clinical trial with RAYALDEE in Mainland China Began in late Q3, managed by Nicoya Therapeutics of Macau and who is the Upcoast partner For the development and commercialization of RAYALDEE in China, Hong Kong, Macau and Taiwan for the treatment of As mentioned by Phil, Our pipeline of long acting products similar to Engenla remains active. You heard about Aqua Biologics entering into a research collaboration agreement with Entera Bio Limited to develop oral peptide tablet formulations for obesity and intestinal Under the agreement, CORE will supply its long acting GLP-two peptide And certain oxintomodulin analogs for the development of oral tablet formulations Using Entera's proprietary oral delivery technology, treatment with glucagon like peptide 2 Analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome And reduce parenteral support requirements. OxyContin Modulin is a naturally occurring peptide hormone found in the intestine With glucagon like peptide 1 GLP-one and glucagon dual agonist activity That suppresses appetite that reduces weight loss. And we have developed several proprietary bonafide oxintomodulin analogs potential candidates for treating obesity, including an injectable pegylated peptide that Demonstrated significant reductions in weight loss and decreased plasma triglyceride levels in the 4 20 patient Phase 2b study.

Speaker 4

Our injectable oxytomogeneic analog, which completed these Phase 2 studies in the U. S. Is being now advanced by LidarMed, our partner in Asia to initiate Phase 3 studies for diabetics and obesity in China And for diabetics in Southeastern Asia in the Q1 of 2024. LiberMed Also plans to launch clinical studies of the long acting Factor 7, which uses Opco Biologic CTP technology Now let me shift gears and I would like to turn to our Diagnostics segment. We have made great strides and we have reduced our operating loss by 41% sequentially from Q2 to Q3 2023 through both expense reduction and revenue growth.

Speaker 4

So a 41% improvement from Q3 Relative to Q2. And we continue to implement our Reach initiative to improve efficiencies, enhance productivity and reduce costs. And we're particularly focused on driving growth in BioReference in our higher value specialty testing segments, Including oncology, women's health, hospitals and health system as well as urology through our proprietary offering the 4 ks score, While continuing to see growth in the standard clinical testing, we have Finalize new service agreements with several new launch clients starting in the Q4, and particularly in our oncology division, GenpaaS, Which continues to build what I consider best in class cancer testing portfolio by launching innovative testing That is clinically relevant to both physicians and patients, as well as pharmaceutical companies and clinical research institutions. Additionally, in the Q4, we'll be launching a cutting edge homologous recombination deficiency test, Which is really important to provide insights into genomic instability and because PARP inhibitor therapies I'm really related to the presence or absence of genomic instability in terms of their efficacy. It will really guide the eligibility of patients for We're also set to unveil an expanded hematological malignancy panel That reinforces our position as the leader in as a leader in this area.

Speaker 4

We've also launched a new service line offering Access to our high quality, reliable and comprehensive data assets and analytics. We realized that we had value embedded in the Thousands of tests that we have performed in genomics and this Offering caters to a wide range of pharmaceutical and clinical research organizations and has already led to new sources of organic revenues. The 4kscore test continues to perform, supported by its recent inclusion in the 2023 American Urology Association guidelines For early detection of prostate cancer and follow-up after PSA screening and for initial and repeat biopsy risk stratification. 4kscore also received additional coverage under Avalon Healthcare Solutions, which manages many state and regional health plans, As well as Aetna's Medicare Advantage Plan and EmblemHealth. BioReference has also expanded its market access And our team has also secured new key payers' participation agreements in recent months, including in network status with CareSource, 1 of the largest managed Medicaid payer in the country, as well as all of EmblemHealth patients.

Speaker 4

And in parallel, our revenue collection processes continue to make great strides since the launch of our revenue cycle management program in Q4 of last year. So in conclusion, we expect that these efforts will further improve financial metrics and return this segment to profitability in the next few quarters. I will now turn the call over to Adam Logau to discuss our Q3 financial results. Adam?

Speaker 5

Thank you, Elias, and good afternoon, everyone. Starting with our Pharmaceutical segment, revenue increased to $46,900,000 for the Q3 of 2023 from $36,900,000 for the comparable period of 2022. Revenue from RAYALDEE and our International Pharmaceutical businesses increased by $8,300,000 reflecting improvements in overall prescriptions and net price as well as improvements in our foreign currency exchange rates in Chile and Mexico. Further, revenue increased as a result of our gross profit share payments from Pfizer Due to increased revenue from the HGH franchise in the European and Japanese regions before considering any U. S.

Speaker 5

Profit share generated from the launch of Ingenla. In the U. S, as a result of the initial launch in mid August, Pfizer is delayed in reporting our gross profit share amounts, And as such, none are included in our Q3 results, but will be caught up in future periods. Costs and expenses were $72,300,000 For the Q3 of 2023 compared to $65,200,000 for the 2022 period, reflecting principally increased revenues and the cost associated. Research and development expenses for the Q3 of 2020 3 were $18,900,000 compared to $17,600,000 for the comparable period of 2022.

Speaker 5

This increase reflects activities for our MODEX development programs, partially offset by decreased spending on our Ingenla development activities. The resulting operating loss for the quarter ended September 30, 2023 was $25,400,000 Or $2,900,000 improvement from the operating loss of $28,300,000 for the Q3 of 2022. Amortization expense related to intangible assets was $16,500,000 for both the 2023 and 2022 quarters. Moving to our Diagnostics segment. We reported revenue of $131,700,000 Compared to $142,900,000 for the 2022 period.

Speaker 5

This decline reflects lower COVID-nineteen testing Costs and expenses decreased by $31,600,000 to $160,800,000 for the Q3 of 2023, down from $192,300,000 for the 2022 period. Operating loss for our Diagnostics segment improved by $20,400,000 or 41 percent to $29,100,000 compared with $49,500,000 for Depreciation and amortization expense included in operating loss were $8,400,000 $8,700,000 for the 2023 2022 periods, respectively. Sequentially, revenues increased by $4,600,000 or 3.6 percent, While cost and expenses declined by $10,500,000 or 6%, reflecting the focused commercial efforts And expense reduction initiatives Elias described earlier. The team at Bau reference continues to focus on growing the specialty lines of business While reducing costs and expenses, while enhancing operating efficiencies to continue to improve our operating margins and return to profitability. Turning to our consolidated results for the Q3, we reported an operating loss of $64,400,000 compared to $87,800,000 for the 2022 quarter.

Speaker 5

Net loss for the Q3 was $84,500,000 or $0.11 per share compared to a net loss of $86,100,000 or $0.11 per share for the 2022 quarter. Net loss for both periods were negatively impacted by the mark to market losses from our Holdings in GeneDx stock with declines of $8,300,000 $30,600,000 respectively, while the 2022 period Benefited from an income tax benefit of $40,000,000 As we look at the quarter ahead, we're We're providing the financial guidance with the following assumptions. For our Pharmaceutical segment, for the 1st 9 months of 2023, Pfizer reported approximately $349,000,000 of global genotropin sales. For the Q4, we have assumed $8,000,000 to $10,000,000 And gross profit share from our partnership with Pfizer. We assume a stable foreign exchange rate for ex U.

Speaker 5

S. Pharmaceutical business, And we expect R and D expenses to reflect higher activities related to MODEX, partially by our recently announced BARDA agreement as well as lower costs and expenses related to the wind down of our clinical operations For the ongoing open label pediatric extension studies for Ingenla. For our Diagnostics segment, We have assumed consistent core testing volumes with growth in our higher margin oncology, women's health and urology specialty lines of testing as well as a slight increase in the average per patient collection amounts due to our revenue cycle management initiatives, partially offset by the impact to the year end holiday season. Further, we anticipate our cost and expenses in the Diagnostics segment to be aligned with the sequential quarter's level of spend. As a result, we expect the following for the 4th quarter: Total revenues between $170,000,000 $180,000,000 revenue from services between 126 And $132,000,000 revenue from product sales between $33,000,000 $36,000,000 And other revenue between $8,000,000 $12,000,000 inclusive of the estimated Pfizer gross profit share.

Speaker 5

We expect Q4 2023 costs and expenses to be between $235,000,000 $240,000,000 $5,000,000 including R and D expense between $18,000,000 $22,000,000 and depreciation and amortization expense of $26,000,000 That concludes our prepared remarks. Thank you all for your attention. And now operator, let's open the call for questions.

Operator

We will now begin the question and answer session. The first question comes from Jeffrey Cohen of Ladenburg Thalmann and Company. Please go ahead.

Speaker 6

Hey, good afternoon and thank you Couple to start with. So Is the Phase 3 from the COIA available online as far as any discussions regarding Endpoints and timelines of the trial and any flavor on the trial as far as number of enrollees And how that's going or number of centers and how that's going?

Speaker 7

Hi, this is Charlie Bishop. The trial in China has only very recently begun. So we don't I have a good estimate as to the timeline and how recruitment is going to go. We haven't released information on the trial design or the total number of subjects But that could change during the course of the study.

Speaker 6

Okay, got it. That's helpful. And I guess one for Adam, as far as the assumptions for Q4, when you talk about the in general revenue Versus Q3, I'm assuming then the if those are unchanged at $4,900,000 $1,400,000 then you're talking about Greater than $2,700,000 from the U. S. And I guess that's your first question.

Speaker 6

Coupled with that, maybe talk about the timeline of Pfizer payments from Q3, is it 1 quarter in arrears or we don't know yet?

Speaker 5

Yes. So it's It's going to be 1 quarter in arrears from the cash payments coming in, Jeff, from the we had about $5,000,000 in sales Without any inclusion from the U. S. In the guide we gave today was 8% to 10% for the 4th quarter. So I think you can imply the math there.

Speaker 6

Okay, perfect. That's very helpful. And then I heard stable on FX. Those are your assumptions for the Q4 as compared to the Q3?

Speaker 5

Yes. That's right.

Speaker 6

Okay, got it. And then, I guess, Finally, as far as the income tax benefit, right, there's a $40,000,000 income tax benefit for the write downs on GeneDx. Can you use that? Did you use any of that? And how what are the parameters around using that?

Speaker 5

Yes. So that benefit was actually that came from last year, But we would be able to use them when we dispose the shares, but not during the interim.

Speaker 6

Okay. You could take the last one. Shares are sold. Okay, got it. And then, could you make available or is it on your website the Two posters that were presented at ISN a few days ago?

Speaker 5

Yes. They should be up there, Jeff, but I'll make sure you get them.

Speaker 6

Okay. Perfect. That does it for us for now. Thanks for taking the questions.

Speaker 5

Thanks.

Operator

The next question comes from Maury Raycroft from Jefferies. Please go ahead.

Speaker 8

Hi, thanks for taking my questions.

Speaker 3

I was

Speaker 8

going to ask one on Ingenla, too. Just wondering if you anticipate being able to break out Ingenla U. S. Revenue and profit share details in the 4th quarter update Or more like sometime first half twenty twenty four. And is there any perspective you can share on how the U.

Speaker 8

S. Launch is going so far?

Speaker 5

So the as it relate we won't break the regions out individually. We'll tell you what the total amounts are. It's not just related to one country. The regions are kind of split the globe into thirds. So any one country It's not going to be broken out for the profit share amounts that we talk about.

Speaker 5

As the launch goes, it's early days. I think The Pfizer team has plans to get on formularies as quickly as possible, which is the major lift in any U. S. Launch. But we're feeling good about The way the product has grown in the international markets and expect the U.

Speaker 5

S. Should follow suit.

Speaker 6

Okay.

Speaker 8

That's helpful. And are there any more specifics you can share on your collaboration with Entera Bio For oral development of your GLP-two peptide and oxidant modulin analogs, specifically is there any more you can say on the economics And time lines for next steps and yes, I'll stop there.

Speaker 2

The relationship is in a very early stage. And so far, we're cooperating with the idea that We will be partners in it, but we haven't defined in financial terms exactly what that means.

Speaker 8

Got it. Understood. And I know there are a couple of studies ongoing with LeaderMed too and wanted to just check on those if there's any perspective or status update

Speaker 4

Those are supposed to start in the next quarter.

Speaker 3

Okay.

Speaker 4

The leader in that studies, both for the Factor VII in the second quarter and

Speaker 8

Okay. And maybe last question related to file reference. You provided some good perspective On the new products and market segments and talked about the expanded customer base, and you aim to get to profitability in the next few quarters. What specific goals either on the revenue or expense side are you aiming to achieve the next few quarters that we should be focused on?

Speaker 4

On the revenue side, the one thing that we want to increase is the volume that goes through our infrastructure. So breaking even means having enough volume to have an optimal profile. So that's the and we have a plan to Increase the daily, what we call accessions by a minimum of 2,000 and reaching for 5,000, Which will bring us to breakeven, maybe like territory above 0. So that's the quantitative objective. In terms of the qualitative, we will be announcing all the New customers we've signed and particularly in oncology over the next few days, few weeks.

Speaker 4

And that really brings a different Because it changes the revenue per accession and that's what we're aiming for. We already reached a better number In the Q3 that we did in the Q2 and hopefully that will be the next parameters that we will track It's the revenue per accession. And then when you include high value tests like the oncology tests and the specialty tests, that number should go up And come to our cost number, we will continue to bring our cost per test down as well. So those are the 3 pillars, if you will. The 4th one, which has been doing well is the trying to capture more revenue through a revenue cycle management, which really didn't exist Before, because the problem of denials and pre authorization is not as large maybe, but we've made a lot of Progress in reducing denials and unbillables and that continues to advance quarter to quarter.

Speaker 4

So Quantitative volume increase, qualitative in terms of the product mix and then better revenue capture.

Speaker 5

Yes, Morgan, I think along those lines, Elias did a good job of capturing those. The sequential improvement in operating Results are really the main measure for us. I think all of the revenue capture and revenue growth is going to result And better operating margins, and we plan to continue to see better operating results Sequentially, we had a good step up from Q2 to Q3 and expect that to continue sequentially.

Speaker 8

Got it. Okay. Thanks for taking my questions.

Operator

Our next question comes from Edward Tenthoff from Tenthoff. Please go ahead.

Speaker 9

Great. Thank you. And congrats on the Progress on really all funds, intrigued by the new collaboration for the GLP. Just to kind of understand a little bit better. So with respect to Pfizer, say that you will recognize, is this All of the revenues or just the U.

Speaker 9

S. Revenues that are 1 quarter delayed? Thank you.

Speaker 5

Hey, Ted. So yes, so Pfizer was just delayed in reporting the gross profit share for the U. S. Region. So we'll have a bit of a catch up quarter.

Speaker 5

We stayed conservative in our guide just because we don't have the data yet to quantify how The U. S. Numbers will get reflected, but we do believe that we'll see that it will be a 1 quarter kind of catch up and then routine after that.

Speaker 9

I got you. So is that $8,000,000 to $10,000,000 in guidance sort of reflective of 3Q and 4Q? Or is that kind of What you would anticipate just for the Q4? Thanks so much for answering the questions.

Speaker 5

Yes. It's just what we would expect For a normal quarter, it doesn't have a catch up with unexpected because it's unknown to us at this point.

Speaker 3

Because

Speaker 9

you don't know. Sure. That's helpful, Adam. Thanks so much, everybody.

Operator

The next question comes from Yale Jen from Laidlaw and Company. Please go ahead.

Speaker 3

Good afternoon and thanks for taking the questions. Congrats on the Nodex collaboration Support by D. BARDA. My question is that in terms of the COVID as well as the future influenza Antibodies, are those mostly just for immunocompromised patients or that will have a broader usage?

Speaker 4

No, that's a good question. No, the COVID antibody we're developing is really a multi specific that will address both Active patients who get the COVID when there is a surge, but there is a background need, Which is the need of immunocompromised patient, estimated between 20,000,000 or 30,000,000 patients in the U. S. Who will need this Continuously, so we think the market will have both the baseline, which is immunocompromised patient and then Surges that may occur during that interval of time. You follow?

Speaker 4

So it's It's 2 components. Yes. It's a multi functional antibody for all COVID-nineteen infections.

Speaker 3

Maybe just a little bit too, Ari, just curious. In terms of this product, if The successful, would that be something OpCo would consider To launch or this is very much stockpiling type of product?

Speaker 4

It's too early to say. It really depends on what we're doing now that we've been funded $59,000,000 to reach the end of Phase 1. And you'll have to really wait for the profile of the product and then decide what you would want to do. We haven't decided that. It's too early right now.

Speaker 3

Okay, great. And maybe the last question here is, talk about the optimizing module In terms of the usage for obesity as well as type 2 diabetes, given this Obesity currently is a very hot deal right now. Could you give us the color in terms of OXO margarines effect clinical effect so far has been low in the obesity

Speaker 4

And at the doses that we were giving. And we believe that the new Analogs of function to Modulin that we have developed will have a better profile. And obviously, we're developing One for the oral formulation that Entera has the technology for, we want to do the feasibility studies of that and then decide how to proceed. The injectable form can also be done with the new Analogs that we are formulating and that decision as to how far you go on that really again is going to Have to wait for some results.

Speaker 3

Okay, great. Thanks a lot and congrats on the progress.

Speaker 4

Thank you. Thank you, Anjali.

Operator

Our next question comes from Dipesh Patel of H. C. Wainwright and Company. Please go ahead.

Speaker 10

Thank you. This is Dipesh on behalf of Yi Chen. Just a trend question from me. Can you provide more clarity around the prescription trend of Engela As well as the bio references testing volume growthdecrease.

Speaker 9

So as far as the

Speaker 5

trend goes for prescriptions for Ingenla, so globally it continues to do very well. I think It's slow going and similar for most newly launched products in the U. S. Market. So I think the trend lines are all positive, and We think there's great opportunity.

Speaker 5

Sorry, can you repeat the second question for me?

Speaker 10

Yes. The second one was If you could just provide some more color around the bio references testing volume growth or decrease.

Speaker 4

Okay. Go ahead, Arnold.

Speaker 5

Yes. I was going to say, it was effectively the total patient volume Year over year was consistent there. It was plus or minus about 0.5%. Sequentially, it continues To be a stable business as well. We're seeing good growth in the specialty lines of testing That the team has been focused on.

Speaker 10

Great. Thank you very much.

Operator

This concludes our question and answer session. I would like to turn the conference back over to Doctor. Frost for any closing remarks.

Speaker 2

I'd like to thank everybody for attending our conference call. And if you have any further questions, Feel free to call any one of us. We'll try to respond. And then we'll look forward to Meeting together again at the end of next quarter. Thank you.

Operator

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

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OPKO Health Q3 2023
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