Good day, and welcome to the OPKO Health fourth quarter 2022 financial results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star, then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Yvonne Briggs with LHA. Please go ahead.
Thank you, operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today's call to discuss OPKO Health's financial results for the fourth quarter of 2022. 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, 2022, and in subsequently filed SEC reports. Conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, February 23rd, 2023.
Except as required by law, OPKO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. Before we begin, let me review the format for today's call. Dr. Phillip Frost, Chairman and Chief Executive Officer, will open the call. Dr. Elias Zerhouni, Vice Chairman and President of OPKO, will then provide an overview of OPKO's pharmaceutical business as well as BioReference Laboratories. After that, Adam Logal, OPKO's CFO, will review the company's fourth quarter financial results. Then we'll open the call to questions. Now I'd like to turn the call over to Dr. Frost.
somatrogon are underway by our commercial partner, Pfizer. NGENLA is our once-weekly injectable growth hormone product developed to ease a patient's burden versus the standard daily injections. Pfizer has launched the product in 15 countries, including Japan, Germany, and the U.K. Expects to have launched in all priority markets by the end of the year. As I mentioned on our last call, NGENLA is starting to post significant sequential quarterly sales growth. Adam will review OPKO's profit share and royalty payments in his prepared remarks. We believe Pfizer is making progress in the U.S. to advance NGENLA through the regulatory process and address the FDA's comments. We continue to work with Pfizer as they stand by their commitment to commercialize NGENLA globally and will provide further updates on its regulatory status in the U.S. and commercial progress in foreign countries.
As for our clinical diagnostics business, BioReference Laboratories is making significant progress in reducing costs and rightsizing the business. In parallel, BRL is expanding its portfolio by focusing on innovation in its specialty testing segments, including oncology, women's health, and urology, while driving growth with novel partnership arrangements. Elias will provide further details on the lab and its performance following his commentary on the pharmaceutical business. With that brief overview, I'll now turn the call over to Elias. Elias?
Yes. Thanks, Phil. Good afternoon, everyone. I think it has been an eventful 2022 for OPKO. I'm looking forward to further progress in 2023 with quite a few significant milestones on the horizon. Let me start with the pharmaceutical business division, where we have made significant progress at ModeX Therapeutics by first enhancing our proprietary platform technologies known as MSTAR and STEALTH, with eight patents filed. These multi-specific antibodies provide flexibilities to go beyond three targets, up to a total of six. We believe MSTAR is a plug-and-play, flexible, adaptive platform that optimizes functionality and manufacturing simplicity. We believe that this provides a competitive advantage over other multi-specific technologies.
In parallel, we have focused on advancing our portfolio significantly, now containing seven assets, one of which is in the clinic in phase I and V in late preclinical stages, with three of the five planned to enter the clinical stages by end of 2023 or beginning of 2024. For infectious disease, we continue to advance the development of MDX-2201, a first-in-class Epstein-Barr virus nanoparticle vaccine. EBV infects up to 95% of the global adult population during their lifetime and is associated with about 1% of all cancer cases worldwide. It also is the leading cause of infectious mononucleosis. Despite the virus's prevalence and its role in causing life-threatening diseases, there are currently no FDA-approved vaccines or treatments for EBV. Our vaccine leverages ModeX's innovative biologics platform to target four major EBV proteins.
This multi-targeted approach improves upon previous efforts and holds potential to provide complete protection against EBV infection. The initial indication for this vaccine will be for infectious mononucleosis, but it's ultimately intended for cancer prevention. Very much like the human papillomavirus, HPV vaccines that protect against cervical cancer. EBV is associated with Burkitt's lymphoma, nasopharyngeal carcinoma, certain gastric and other cancers. It has the potential to prevent over 200,000 malignancies associated each year with this virus. Potentially could be indicated for multiple sclerosis, a disease now believed to also be associated with the Epstein-Barr virus. We also have a tri-specific candidate in phase I clinical trials to treat HIV that has received funding from the NIH, as well as two pre-clinical tri and tetra-specific candidates with increased potency that also target HIV.
We hope to investigate the potential for such multi-specific antibodies to suppress virus replication after interruption of antiretroviral drug treatment. Such a therapy could potentially decrease the need for continuous drug treatments, whose multiple side effects cause secondary complications and decrease therapeutic compliance. We have several SARS-CoV-2 multi-specific antibodies in late pre-clinical testing, partially funded by DARPA. These candidates potently neutralize all known circulating variants of the virus and may help to limit the continued spread of the virus. We're particularly interested in exploring whether such antibodies could be used to protect subjects with weakened immunity, such as patients with cancer, diabetes or asthma or autoimmune diseases. There is also an interest in using such antibodies to treat long COVID, a complication of COVID infections. We have two multi-specific, multifunctional antibodies focused on hard to treat solid tumors and one focused on liquid tumors.
These oncology programs are in the pre-clinical stage with a goal of entering the clinic in early 2024. We've also worked to make ModeX more visible to the outside world with a busy schedule presenting at several scientific meetings. In January, we presented at the Safety and Efficacy of Bispecific Antibodies, ADCs, and Combination Therapy conference regarding our tri-specific antibody technology. On the 22nd of this month, we participated in the Keystone Symposia on Molecular and Cellular Biology and presented a poster titled Tri-Specific Antibody Targeting HER2 and T-cells Inhibiting Breast Cancer Growth via CD4 cells. In March, our team will be at the Festival of Biologics, presenting multi-specific targeting for the treatment of infections and cancer.
Taken together, ModeX Therapeutics represents a fundamental change in the direction for OPKO, shifting the balance from diagnostics to therapeutics and offering innovative solutions to pressing unmet needs for cancer and viral disease prevention and treatment. We will present a more complete view of our R&D portfolio on March 20th, 2023. In addition, the pharmaceutical division is working to advance RAYALDEE for the correction of secondary hyperparathyroidism, a major complication of chronic renal disease, and exploring new strategic partnerships to accelerate its commercial growth. We're also exploring strategic partnerships to advance our programs in Alzheimer disease and cognition loss and have supported as well, during the past few months, the response of Pfizer to the FDA for the approval of somatrogon. Now I'd like to turn to our diagnostic segment and discuss BioReference Laboratories.
Our continued priority is to return this business back to profitability post-COVID. As such, we have been aggressively reducing costs and have reached our stated goal of eliminating approximately $140 million of annualized expenses since February 2022. We will continue our REACH initiative, which is designed to improve productivity and reduce costs, which has touched every part of the organization, and we're targeting more than an additional $30 million of reductions or about 5% of our expected spend in 2023. As I mentioned on my last call, we continue to focus on operational excellence, including revenue cycle management, while pursuing efficiencies in virtually every aspect of this business.
Including refocusing on our higher margins products post-COVID and geographic redeployment of our patient service centers with 11 new patient service centers opened so far and 13 less productive centers closed in 2022. We stabilize our core testing business, our higher margin specialty testing segments continue to outperform. Phillip Frost mentioned, these segments include oncology, women's health, urology, and special ventures. We're focused on continuing to drive growth in these segments by bringing innovation to the portfolio. For example, within oncology, cancer genomics continues to be a strong growth area for GenPath with several new offerings in 2022. During the fourth quarter, we entered into partnerships with large academic centers such as University of Rochester and University of Pittsburgh as examples. During the quarter, we also launched a new service for patients that previously received Oncocyte advanced NGS testing. Let me explain.
Typically, oncologists order a reduced set of genetic markers specific to each cancer type, about 50. However, BioReference has developed technology that is able to analyze simultaneously all 525 cancer-relevant genetic abnormalities. The reanalysis of this comprehensive data set with our analytical software can help physicians who need to look beyond specific small panels to guide their therapy options. By reanalyzing the full genetic panel, it also enables oncologists to better assess the biology of the cancer in their patients and guide either therapy or, as we found out, inclusion in relevant clinical trials offered by pharma or biotech company without the need for resequencing, an area of great interest and also a new avenue for increased revenues.
Our commercial footprint has expanded during the fourth quarter of 2022 with the addition of eight new oncology sales territories, as well as five new molecular oncology sales roles who will focus on our cancer genomics offering in large cancer centers, health systems, and large oncology practices. In early 2023, we will be launching new testing to exclude the expanded Oncocyte portfolio and expanding also minimal residual disease portfolio following the very high demand by oncologists for this testing. In urology, we have expanded the commercial team with five new urology territories for 2023 growth, as well as training and incentivizing our entire sales team on selling the 4Kscore test in all their call points and markets. During the fourth quarter, the urology team brought on 68 new accounts, which have promising implications for a fast start to 2023 for growth.
In women's health, we continue to build strong relationships with our large practice groups, which continue to expand and create meaningful opportunities as we look forward into 2023. In terms of innovation, in early 2023, we will be launching our new CINtec PLUS cytology testing, which allows physicians to identify women who are at high risk for the presence of cervical dysplasia and who need intervention versus a watch versus wait approach. Typically, this test applies to patients who have a negative Pap smear or some dysplasia, but positive HPV virus tests. CINtec can then differentiate whether the HPV viruses are active and therefore dangerous and could lead to the development of cancer and will require intervention rather than yearly or bi-yearly follow-ups. BioReference will be the first national reference lab with this offering.
In terms of the clinical services and hospital services, we continue to expand our partnership with Westchester Medical Center and are commencing our efforts on their outreach business, which will lead to growth as we head into the first quarter of 2023. We continue to expand our focus in the urgent care sector, expanding our existing relationships, bringing on 20 new offices in the fourth quarter of 2022, as well as establishing a new urgent care network in the Northeast. In Q4, we launched a new comprehensive respiratory panel that included the most common viral diseases for the fall of 2022, flu A and B, COVID, and RSV. This provided an easy way for clients to order testing with 1 swab and identify which potential virus they needed to treat.
This was very well received in the marketplace as we were one of the first national labs to launch this type of panel. We've also expanded our hospital team, focused on new business for 2023, and expanded our clinical team with roles focused on retention of our current business and minimizing attrition. In summary, our vision for BRL is to move Bio-Reference back to profitable growth following the drastic reduction in COVID revenues experienced by the entire industry, and to do so as soon as possible during 2023. I'm very hopeful that these efforts will be apparent to you in the second and third quarter, and I will now turn the call over to our CFO, Adam Logal.
Thank you, Elias. Starting with our pharmaceutical segment, revenues for the three months ended December 31st, 2022 were $46 million, an increase of $7.4 million from the comparable period of 2021. Total costs and expenses for the 2022 quarter were $67.9 million, including $16.5 million of non-cash intangible amortization. Research and development expenses were $16.6 million, which is consistent with the fourth quarter of 2021. Operating loss from our pharmaceutical segment was $22 million for the fourth quarter, compared to an operating loss of $14.8 million for the prior year quarter. The increase in losses reflects the amortization of our intangible assets upon the approval of NGENLA earlier in 2022.
Moving to our diagnostics segment, we reported revenue for Q4 of 2022 of $139.4 million compared to $362.8 million for the 2021 period. This decline reflects lower COVID testing volumes as the market shifted to rapid at-home testing earlier this year. We continue to execute our REACH expense reduction program, as Elias mentioned. We have reduced our expense run rate by over $140 million and realized benefits from this program in each sequential month during the quarter. As Elias mentioned, we have identified a number of near and medium-term growth programs that we expect to realize in the first half of 2023, which will help return BioReference to profitable growth.
Operating loss for our diagnostics segment was $23.3 million for the quarter, which reflects a sequential improvement of approximately $26.4 million. In the fourth quarter of 2021, we reported an operating loss of approximately $18.6 million. Turning to the consolidated financial results for the quarter, we reported an operating loss of $55.3 million compared to Q4 2021 operating loss of $63.1 million. Net loss for the fourth quarter of 2022 included a $49.1 million non-cash mark-to-market adjustment, reflecting the decline in value of our equity holdings in GeneDx, formerly Sema4. Partially offset by an income tax benefit of $17 million, resulting in a net loss of $85.2 million, or $0.11 per share for the quarter.
This compares to a net loss of $73.8 million or $0.11 per share for the 2021 period. As we look at the year and quarter ahead, we're providing financial guidance with the following assumptions. For our pharmaceutical segment, because the timing is not certain, we have not assumed the approval of NGENLA by the U.S. FDA in our forecast. Approval would result in a milestone payment of $90 million, and we have also not assumed the U.S. region for NGENLA will be in the gross profit share. We also have assumed, beginning in Q2 2023, that the EU region will shift to a gross profit share from the royalty structure currently in place.
We assume V ifor will receive pricing determinations and will launch RAYALDEE in additional EU territories, thereby triggering a $7 million milestone payment, likely in the first half of 2023. We assume a stable FX rate for our ex-U.S. pharmaceutical business, as we have seen a 10% impact on our business over the last 12 months. For our diagnostics segment, we assume COVID testing volumes will continue to decline throughout 2023. We have assumed modest growth in core testing volumes with stronger growth in our higher margin oncology, women's health, and urology specialty lines of testing. We've also assumed the full impact of our REACH program, delivering an additional $30 million of cost savings in 2023, or more than 5% of our total diagnostic spend.
Due to the significant variables in our revenue and spending plans outlined, we have limited our outlook to the first quarter and look forward to providing additional updates during our first quarter conference call. For the first quarter of 2023, we expect the following: total revenues between $165 million and $185 million, with revenue from services between $130 million and $140 million, revenue from product sales between $30 million and $35 million, and other revenue between $5 million and $10 million. We expect Q1 2023 costs and expenses to be between $230 million and $245 million, including R&D expense between $20 million and $24 million and depreciation and the amortization expense of $25 million.
As we progress through 2023, we expect to enter into at least one non-dilutive licensing transaction for one of our early-stage programs that Elias described. We will manage our investments in new R&D programs and commercial initiatives to our available cash resources. That concludes our prepared remarks. Thank you for your attention. Now, operator, let's open the call for questions. Operator?
We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Maury Raycroft with Jefferies. Please go ahead.
Hi, this is Kevin on for Maury. Thanks for taking my questions, and congrats on the update. I just had a first one on somatrogon. Is there any granularity you can say about what sort of update we could expect this year from Pfizer? Would this likely be a resolution either way, or could it be a status update? On timing, could this be a mid-year update, and what are some of the drivers behind potential timelines there?
Hi, this is Steve Rubin. We do expect some form of definitive communication from FDA around NGENLA. You know, obviously hoping for by mid-year, but I can't guarantee when that will be. We do expect that to be a definitive yes or no at that point.
Okay, great. Thanks. A quick question for Adam. You mentioned, you expect NGENLA to shift to gross profit share in Europe in, I think, I believe 2023. Is there any granularity on when that could be and what the gating factors are there to that shift?
Hey, Kevin. We expect what requires in the European region to move to gross profit share is for us to get pricing in two additional major markets. We have pricing in Germany. There's the other major markets are expected to launch this year. We've guided that we expect them in the first half of this year in Q2 for the territory to shift to gross profit share.
Okay, great. Thanks. Just a last one for Elias on, maybe the ModeX pipeline, just the types of deals or partnerships that you're looking to make there, and when we might see an update, in that regard, potentially this year.
It depends on each product. In terms of the portfolio, we've had a lot of incoming interest both for the multispecific antibodies as well as the vaccine. We're in active conversations. I hope to see one or maybe two transaction complete this year, hopefully in the first half. The structure of it is pretty classic. In other words, upfront plus milestones plus royalties. This is the dominant type of transaction we're looking for. Others are looking for more long-term collaborations, and that can be variable depending upon the scope of the collaboration. We will also keep some products and attempt to develop them with our own resources because they're very, very valuable.
Great. Thank you for taking my questions.
Hope that helps.
Yes. Thanks.
The next question comes from Jeffrey Cohen with Ladenburg Thalmann & Co.. Please go ahead.
Hi, good afternoon. Thanks for taking our questions. I guess to start, Adam, any commentary, generally speaking, on the margins which were better than we thought? Any pull-through? It looks like they're bouncing back a little on a linear basis.
There's a couple of things that obviously the REACH program, you know, had its biggest impact during Q3. We saw a full quarter of the Q3 exits and reductions that we expected to see. That was one of the drivers. We also received a $2.5 million payment on the pharmaceutical side of our business from our Chinese partner for the commercialization or development activities that are ongoing in China for RAYALDEE. Those are the two main drivers, Jeff.
Okay. Got it. I guess next, Elias, could you talk a little further about this urgent care network and number of facilities, where they're located, what a typical facility looks like as far as size and scope?
You're talking about the patient service centers? I couldn't hear your question.
Yes.
What we did, we did a full analysis of the return on investment, if you will, of each PSC in the system. What we found is that there are some that really were not either located in the optimal position, some that, when you looked at the totality of the revenue and expenses, needed to be displaced or closed. Then we opened 11 ones in very promising, you know, locations that really attract not just their own clients, but also a volume that we're starting to see, whereby you can do what I think our minimum productivity requires, which is 50-60 draws a day.
With the increase in reimbursement, for draws, as you know, we expect then that investment, if you will, and redeployment to be very positive, to the revenue line.
Okay, got it. Could you talk a little bit more about the on-site testing?
Right.
how the payers and the money flows on that?
The team at GenPath did an excellent job with their approach to full gene sequencing. They're able to do all the 525 tests in one run. At a turnaround time that is basically industry best with three-five days. As you know, the CPT codes are specific to each one type of cancer that a patient may have, a breast cancer or a colon cancer. Typically, the oncologist, the treating oncologist requires to reduce that. However, as the patient goes on, first line, second line, and so on, there may be a need for readjusting the therapy, understanding maybe what other pathways are really active in that tumor, whether it be a liquid tumor or a solid tumor.
There is a demand for going back in two areas. One is understanding better the biology of the cancer, and two, figuring out if there is minimal residual disease or not. We developed two approaches. One is to say, and we have the software for it, to look back at the whole set, 100, 525, and inform the oncologist for that particular patient.
What we found is that the highest demand is really for clinical trials in oncology by large oncology practices like U.S. Oncology and others who say, "We want to participate in trials, but we want to know what are the gene, the genetic abnormalities that the pharma companies and the biotech companies are looking for." Many, many therapies today are developed as a function of the genetic makeup of the cancer that the patient harbors. This is what we put in place. Now we're going to launch the minimal residual disease test, which will complement, you know, our full offering to oncology. I hope that's clear.
Yeah, that's very helpful. Thanks for that. Lastly, I heard a comment about March 20th, the complete portfolio analysis. What will that be, and where will that be?
I'll let Gary respond. He's preparing that.
Hi, this is Gary Nabel. We're planning to have the R&D Day as a virtual event. It will be on March 20th at 4:00 P.M. We'll be providing the specifics in terms of logging in. At that time, what you'll hear is you'll hear about the evolving portfolio, starting with the multi-specific antibodies, their applications to solid tumors, liquid tumors. We also will cover the infectious disease portfolio, HIV, SARS-CoV-2, in addition to that, some work on other emerging pathogens. Finally, as Elias described, the EBV vaccine, what the statuses of the programs and what the prospects are for the future.
We're really looking forward to sharing, you know, our excitement about the portfolio and really the advantages that our new technologies offer for a variety of diseases.
Just as an add-on, Gary, if you allow me. The EBV vaccine is the most advanced in our portfolio and is likely to enter the clinic by the end of the year, beginning of next year as well. It's one of those molecules, I mean, programs that are pretty much going through the last stages of IND approval.
Got it. Okay, that's super helpful. Thank you. Thanks for hopping on, Gary.
Sure. Thank you.
The next question comes from Edward Tenthoff with Piper Sandler. Please go ahead.
Great. Thank you very much for the update, and I'm really looking forward to the R&D day, next month. I guess my question has to do, just with respect to, overseas and really how NGENLA is doing. You know, are you seeing competition at this point, from SKYTROFA? And how much of a delay do you think in terms of ultimate competition in the U.S. is the, you know, head start that SKYTROFA's gotten? How much of a, you know, setback do you think that might be for the ultimate market share here in the U.S.? Thanks so much.
Take that, Adam Logal. I'll start off, and I'm sure others will weigh in. Outside of the U.S. right now, at least in the Japanese markets or Japanese region, you know, we don't expect long-acting growth hormones to enter that market for a few years. In Europe, you know, there is a head start that Pfizer has had on SKYTROFA as well. SKYTROFA won't be launched until the second half of this year in the European market. There is a good deal of progress that Pfizer's been able to make in that market. As far as the U.S. delays go, you know, there's a big market.
You know, payer landscapes are challenging for all new entrants into the market, which may have impacted SKYTROFA's launch. We think Pfizer's, you know, well-positioned once they do have approval to launch in the U.S. We expect it to be a competitive market. Today, it's fragmented with seven players in the daily market, so having two or three competitors should put us in a good spot.
Just one more thing, if I could, Adam.
Sure.
In addition to the upsides, or setbacks, as you ask, there's one element that is important, and that is if and when, hopefully, we get approval for the FDA, our R&D expenses in somatrogon will decrease significantly because we're keeping sites open with extensions as long as we haven't finalized the approval of that. That will also help in the balance sheet, if you will, of the program that I don't think is taken into account. Maybe Adam can give you the numbers eventually.
Great. I appreciate that color. Thank you.
The next question comes from Yale Jen with Laidlaw & Company. Please go ahead.
Good afternoon, and thanks for taking the questions. My current first question is in terms of NGENLA, doctors selling in Europe and you will start to have a profit sharing later this year. Do we anticipate either Pfizer or you guys provide some sales figures over those territories into to provide more colors?
Pfizer, I don't know what their plans are to split out NGENLA's revenue numbers. We wouldn't provide those. You know, when it becomes material to the overall financials of OPKO, we would potentially break out the profit share royalty income that we're receiving from it.
Maybe a follow-up question on this one is that, I think in the press release, they mentioned that there's all priority markets to be launched this year. Could we get a little bit more color in terms of what constitutes the priority markets in this statement?
It's the major pharmaceutical markets, is the way I would define it.
Okay. Maybe the last question here is in terms of the diagnostic sector, the groups. Could we get some sense of, in terms of the headcount, from the height of the COVID days to recently, as well as how does that compare to the pre-COVID days, in that regard?
Yeah. I can answer that question, Jane Hsiao. At the peak of the COVID, basically at the end of 21, beginning of 22, 8,000. Today, we're 3,300.
Okay. How would that also compare to prior to the COVID?
In 2019, it was the same headcount, 3,300.
Okay, great. That's very helpful and thanks and congrats on the, all the progresses.
We're still working on it, as Adam mentioned.
Okay, great. Oh, sorry.
Go ahead.
Just as we said, to bring.
Excuse me. Just a moment.
To bring the company back to profitability, we are hoping to achieve another $30 million of efficiencies.
Thank you. The next question comes from Yi Chen with H.C. Wainwright. Please go ahead.
Hi, thank you for taking my question. First question, just to clarify, have you disclosed how much royalty, based on sales of somatrogon, you have received in the first quarter?
We have not broken it out separately, no.
Okay. Do you plan to do that at some point in the future?
Yeah. Once the number becomes a material number, which, you know, you could expect could happen later this year based on the gross profit share shifting or the royalty scheme in Europe shifting to a gross profit and the potential U.S. market coming online.
Okay. Has Pfizer indicated whether when there will be an update regarding the U.S. resubmission? Could it be first half of this year or second half of this year?
No one knows exactly when. You know, Pfizer is in regular dialogue with FDA towards approval. I mean, we hope it to be first half of this year. They haven't provided a specific date.
Okay. Lastly, could you comment on the most recent trend of diagnostic volume, specifically for non-COVID tests, and whether you still expect the diagnostic segment of revenue could resume growth in the first half of this year? Thank you.
That's exactly what we're working on. It is actually essentially the same level as 2019 base. I'm talking about the core business now. As, as Adam said, we're planning on a growth of that core business of about 3%-4%. The main growth is gonna come from the specialty testing, as I described in oncology, urology, women's health, and also large health systems partnerships.
Okay. Got it.
Which is in the high single-digit %, low double-digit % range.
All right. Thank you.
This concludes our question and answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks.
Thank you for your questions and for your interest in OPKO. As you've heard, we are working on all fronts. There's great interest in the progress of NGENLA and your questions about what's forthcoming in the United States are of great interest, of course. You can be sure that Pfizer, working with our team, address the questions that were raised by the FDA. We think that they were answered in a very positive, favorable way. We hope the FDA agrees with us. So far as the rest of the business is concerned, as was pointed out, we have a lot of work to do, but we're working diligently with the BioReference business to bring it back to where it should be and where we think it will be.
So far as RAYALDEE is concerned, we didn't talk much about it, but you can be sure that we're working very hard to increase the revenues and profitability, and we're enthusiastic about the work that our partners are doing on the product as well. I'll leave you with that, and hope that as many of you as possible will participate in the R&D event on the 20th of March, and we'll look forward to again meeting with you to discuss the first quarter results. Thank you and have a good evening.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.