Q4 2022 OPKO Health Inc Earnings Call
Good day and welcome to the Opco health.
Health fourth quarter 2022 financial results conference call all participants will be in listen only mode should you need assistance. Please signal 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 me.
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 L. H a please go ahead.
Thank you operator and good afternoon. This is Yvonne Briggs, but they'll AJ. Thank you all for joining today's call to discuss Opco health 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.
This call contains time sensitive information that is accurate only as of the date of the live broadcast today February 23, 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 Dr. Phillip Frost, Chairman and Chief Executive Officer will open the call.
Dr Elliot, Sir Honey, Vice Chairman and President of Opco will then provide an overview of opco pharmaceutical business as well as bio reference laboratories.
After that Adam logo Opco CFO will review the company's fourth quarter financial results and then we'll open the call to questions.
Now I'd like to turn the call over to Dr. Frost.
Yeah.
So macro dawn are underway for our commercial partner Pfizer and <unk> is our once weekly injectable growth hormone product developed who he's a patient's burden versus the <unk>.
Standard daily injections.
Once a product in 15 countries, including Japan, Germany, and the U K and expects to have launched in all priority markets by the end of the year.
As I mentioned on our last call in January is starting to post significant sequential quarterly sales growth and Adam will review up gross profit share in royalty payments in his prepared remarks.
We believe Pfizer is making progress in the U S to advance in general through the regulatory process and address the Fda's comments, we continue to work with Pfizer as they stand by their commitment to commercialize.
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 My reference laboratories is making significant progress in reducing costs and right sizing the business in parallel.
<unk> is expanding its portfolio by focusing on innovation and our specialty testing segments, including oncology women's health and urology, while driving growth with novel partnership arrangements.
Oh, Yes, we will provide further details on the wired minutes performance following his commentary on the pharmaceutical business.
With that brief overview I'll now turn the call over to Oh, Yes, yes, yes.
Yes, Thanks, Phil and good afternoon, everyone.
I think it has been an eventful 2022 for Opco and I'm looking forward to further progress from 'twenty to 'twenty three with quite a few significant milestones on the horizon.
Let me start with for the part with the pharmaceutical business Division.
We have made significant progress at <unk> therapeutics by first enhancing our proprietary platform technologies known as M Star and start with eight patents filed these.
These are multi specific.
Antibodies provides flexibilities to go beyond three targets up to a total of six.
We believe I'm, sorry, as 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 one and five in late preclinical stages with three of the five planned to enter the clinical stages by the end of 2023 or beginning of 2020.
Sure.
Or infectious disease, we continue to advance the development of Mdx keeps the old one.
First in class Epstein Barr virus nanoparticle vaccine.
He'd be the infects up to 95% of the global adult population during their lifetime.
And is associated with a one 1% of all cancer cases worldwide.
It also is the leading cause of infectious mononucleosis.
Despite the virus is prevalence and its role in causing life threatening diseases. There are currently no FDA approved vaccines or treatments for E D.
Our vaccine leverages boxes innovative biologics platform to.
The targets for major EBV proteins.
Multi targeted approach improves upon previous efforts in hopes potential to provide complete protection against EBV infection.
The initial indication for this vaccine will before infectious mononucleosis, but it's ultimately intended for cancer prevention.
Very much like the human capital Papilloma virus HPV vaccines that protect.
Protect against cervical cancer E.
E T v's associated with Burkas unemployable.
He's a pharyngeal carcinoma, certain gastric and other cancers. So it has the potential to prevent prevent over 200000 malignancies.
Each year with this virus and potentially.
It could be.
Indicated for multiple sclerosis disease now believes to also be associated with the Epstein Barr virus.
We also have a tri specific candidate in phase one clinical trials to treat HIV has received funding from the NIH as well as two preclinical cry and Tetra specific candidates with increased potency, but also target HIV.
We hope to investigate the potential for such multi specific antibodies.
Suppress virus replication after interruption.
Hi, retroviral drug treatment.
Such a therapy could potentially decrease the need for continuous drug treatments.
Whose multiple multiple side effects called secondary complications and decrease therapeutic compliance.
In addition, we have several Sars cov, two multi specific antibodies late preclinical testing partially funded by DARPA.
These candidates Potently neutralized.
Non circulating virus the virus.
We 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 autoimmune diseases. There is also an interest in using such antibodies to treat long COVID-19 a complication.
Covid infections in.
We don't call a G. We have two more.
Multi specific multi functional antibodies focused on hard to treat solid tumors and one focus for liquid tumors.
Oncology programs on the preclinical stage with a goal of entering the clinic in early 2024.
We've also works to make <unk> more visible to the outside world with a busy schedule presenting at several scientific meetings in January we presented the safety or efficacy of bi specific antibodies.
He sees in combination therapy conference regarding a tree.
Vic antibody technology.
The 22nd of this month, we participated in the Keystone Symposium on molecular and cellular biology, and presented a poster titled Tri specific antibody targeting <unk>, two and T cells.
Inhibiting breast cancer growth.
<unk> four cells.
In March our team will be at the festival of biologicals, presenting multi specific targeting for the treatment of infections in cancer taken together.
Phoenix represents a fundamental change in the direction for optical shifting the balance from diagnostics and therapeutics and offering innovative solutions to pressing unmet needs for cancer and viral disease prevention and treatment.
And 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 ROI LD for the correction of secondary hyperparathyroidism, Tyler just 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 and all the time with disease and cognition loss and have supported.
As well during the past few months.
Responsive Pfizer to the FDA for the approval so much about.
Now I'd like to turn to our diagnostics and.
And discuss by restaurants and other choice.
Our continued priority is to return this business back to profitability post COVID-19.
We have been aggressively reducing cost.
And have reached our stated goal of eliminating approximately $140 million annualized expenses since February 2022.
We will continue our reaching.
It reached 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%.
Spectrum spend in 2023.
As I mentioned on last call, we continue to focus on operational excellence, including revenue cycle management.
Pursuing efficiencies in virtually every aspect of this business, including we focusing them on higher margins products post COVID-19.
And geographic redeployment of our patient service centers with 11, new <unk>.
Patient service centers opened so far and 13 less productive centers closed in 2022.
As we stabilize our core testing business.
Higher margin specialty testing segments continue to outperform.
As Phil 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 genpact with several new offerings in 2022.
During the fourth quarter, we entered into partnerships with large academic centers, such as University of Rochester, and the University of Pittsburgh as examples.
During the quarter.
We also launched launched a new service for patients.
Because she received uncle site advanced N G S tested let.
Let me explain typically oncologists order and reduced set of genetic markers specifics of each cancer type about 50, However, bio reference as developed technology that is able to analyze simultaneously all 525 cancer relevant genetic abnormalities.
Re analysis of this comprehensive dataset with our analytical software can help physicians, who need to look beyond specific small panels to guide the therapy option.
But realizing full genetic panel. It also enables oncologists to better assess the biology of the cancer and their patience and guide either therapy or as we found out inclusion and relevant clinical trials offered by pharma or biotech company without the need for <unk>.
<unk> City, an area of great interest and also a new Avenue for increased revenues at <unk>.
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.
We'll focus on lung cancer genomics offerings in large cancer centers health systems, and large oncology practices in early 2023 we will be launching new testing to exclude the expanded unco site portfolio and expanding also minimal residual disease portfolio.
So following the very high demand by oncologists for this testing.
In urology, we've expanded the commercial team with five new urology territories for 2023 go as well as training and incentivizing our entire sales team on selling the four K score test and all of their cold points in market share.
During the fourth quarter. The urology team brought on 68, new accounts, which are promising applications for a fast start to 2023 for growth.
In women's health, we continue to build stronger relationships with our large practice groups, which continued to expand and create meaningful opportunities as we look forward to 2023.
In terms of innovation in the early 2023, we will be launching our NUCYNTA 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 supplies to patients will have a negative pump smear or some dysplasia, but positive HPV virus test.
Doug can then differentiate whether the HBV viruses are active and therefore dangerous and could lead to the development of cancer and will require an intervention rather than yearly you buy yearly follow ups I referenced will be the first national reference lab offering.
In terms of the clinical services and hospital services, we continued to expand our partnership with Westchester Medical Center.
Commencing our efforts on their outreach business, which will lead to growth as we head into the first quarter of 2023.
Additionally, we continue to expand our focus in 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 best perjury panels that included the most common of viral diseases for the fall of 2022 flu and be Covid in RSV.
This provided an easy way clients to order testing with one 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 the stockpile.
We've also expanded our hospital team focused on new business for 2023 and expanded our clinical team with roles focus on retention of our current business.
And minimum minimizing attrition.
In summary.
Our vision for BRL has to move by reference back to profitable growth. Following the drastic reduction in COVID-19 revenues experienced by the entire industry and to do so as soon as possible during 2023.
I am 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 mobile.
Thank you Elliot.
Starting with our pharmaceutical segment revenues for the three months ended December 31, 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 noncash intangible 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.
In general 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-19 testing volumes as the market shifted to wrap it at home testing earlier. This year, we continue to execute our reach expense reduction program as Elliot mentioned, we've reduced our expense run rate by over $140 million and realized benefits from this program in each sequential.
<unk> month during the quarter.
As Elliot mentioned, we have identified a number of near and medium term growth program that we expect to realize in the first half of 2023, which will help returned by a reference 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.
2022 included a $49 1 million noncash mark to market adjustment, reflecting the decline in value of our equity holdings in gene Dx formally semaphore.
Partially offset by an income tax benefit of $17 million, resulting in a net loss of $85 $2 million or <unk> 11 per share for the quarter. This compares to a net loss of $73 $8 million or 11 cents per share for the 2021 period.
As we look at the gear 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 Peru approval of in general by the U S. F D. A and our forecast approval would result in a milestone payment of $90 million and we have also not assumed the U S region for in general will be in the gross profit share.
We also have assumed beginning in Q2 2023 that the U EU region will shift to a gross profit share from the royalty structure currently in place.
We assume though before will receive pricing determinations and will launch rally 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 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, and we have assumed modest growth in core testing volumes with stronger growth in our higher margin oncology women's health and neurology specialty lines of testing.
We've also assumed the full impact of our reach program delivering an additional $30 million of cost and it cost savings in 2023 or more than 5% of our total diagnostic spend.
Due to the significant variables in our revenue and spanning plan outlined we've limited our outlook for the first quarter look forward to providing additional updates during our first quarter conference call for.
For the first quarter of 2023, we expect the following total revenues between 165 and $185 million with revenue from services between $130 million to $140 million revenue from product sales between 30, and $35 million and other revenue between five and $10 million.
We expect Q1, 2023 costs and expenses to be between 230, and $245 million, including R&D expense between 20 and $24 million and depreciation in the Ameren ammar.
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 Elliot described we will manage our investments in new R&D R&D.
R&D programs and commercial initiatives to our available cash resources.
That concludes our prepared remarks, thank you for your attention and 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'd like to withdraw your question. Please press star.
<unk> then too.
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.
Our first one on so much argon.
Is there any granularity you can say about what sort of update we can expect this year from Pfizer and would this likely.
Likely be a resolution either way or could it be a status update and then on timing could this be a mid year update and what are some of the drivers behind our potential timelines there.
So hi, this is Steve Rubin, we do expect.
Some form of definitive.
Communication from FDA around an agenda so.
Hobby, hoping for by mid year, but I can't guarantee when that will be but we.
We do expect that to be a a.
I defended yes, we're now at that point.
Okay, Great. Thanks, and then a quick question for Adam You mentioned, you expect a shift to gross profit share in Europe , and I think I believe 23 is there any granularity on when that could be in and what the gating factors are there to that shift.
Hey, Kevin Yeah. So we expect what requires in the European region to move to a gross profit share is is for the Wii.
Perhaps to get pricing into two additional major markets.
We have pricing in Germany.
The other major markets are expected expected the launch this year, we guided that we expect them in the first half of this year and in Q2 for the territory to shift to gross profit share.
Okay, great. Thanks, and just a last one for for L. S. On.
And maybe the pipeline.
Just the types of deals or partnerships that youre looking to make there and when we might see an update in that regard potentially this year.
So it depends on each products and in terms of the portfolio. We've had a lot of incoming interest both for the multi specific antibodies as well as the vaccine.
So we're in active conversations I hope to see one or maybe two transaction will complete this year.
Hopefully in the first half.
The structure of it just truly classic in other words upfront plus milestones plus royalties and 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 but we will.
Also keep some follow ups.
In an attempt to develop them with our own resources, because they're very very valuable.
Great. Thank you for taking my questions yes.
The next question comes from Jeffrey Cohen, with Ladenburg Thalmann <unk> company.
Please go ahead.
Oh, hi, good afternoon, thanks for taking our questions. So I guess to start.
There are many commentary generally speaking on the on the margins, which were better than we saw at any pull through it looks like your.
And once you back a little on a linear basis.
Yeah. So there's a couple of things that obviously the reach program.
<unk> had its biggest impact during Q3, so we saw the full quarter of the Q3 exits and reductions that we expected to see so that was one of the drivers.
We also received them.
On a two and a half million dollars payment on the pharmaceutical side of our business from our Chinese partner for the commercialization of <unk>.
<unk> activities that are ongoing in China for reality. So those are the two main drivers Jeff.
Okay got it.
I guess could you talk a little further about this.
Urgent care in their work and number of facilities, where they're located what a typical facility looks like as far as size and scope.
He's talking about the patient service centers I Couldnt hear your question.
Yes.
Okay. So what we did we did a full analysis of the return on investments. If you will of each PSC in the system and what we found is that there are some that really were not either located in the optimal position. Some that are what you'd looked at the totality of the revenue.
And expenses needed needed to be displaced or close and then we opened 11 once it's very promising.
So locations that really attract not just their own clients, but also a volume.
We're starting to see whereby you can do what I think our minimum activity requires which is 50 to 60 drops a day with the increase in AR.
Reimbursement for <unk>.
For draws as you know we expect then that investment if you will and redeployment to be very positive.
Two two to the revenue line.
Okay got it and then could you talk a little bit more about the.
The answer sorry testing right.
How how the payers and the money flows on that.
So the team at Gen. Paas did an excellent job with their approach to the full GNC owned gene sequencing and so they are able to do all of the 525 tests in one run.
Ah the turnaround time that is basically industry best with three to five days, but as you know the CPT codes are specific to each one type of cancer.
She may have a breast cancer colon cancer and so.
So typically the oncology as the treating oncologist requires the reduce it.
However, as the patient goes on first line second line and so there may be a need for readjusting the therapy understanding maybe what other pathways are really active in the tumor.
Whether it be liquid tumor of solid tumors. So there is a demand for going back in two areas. One is understanding better the biology of the cancer and to figuring out if there is minimal residual disease or not so we developed two approaches one is to say.
We have the software for it to look back at.
The whole set on 525 and inform the oncologist for that particular patient, but 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. We said we want to participate in trials, but we wanted to know what are the.
Jean.
The genetic abnormalities that the pharma companies in the biotech companies are looking for and so many many therapies today is a develops as a function of the genetic makeup of the cancer that the patient harbors and this is what we put in place and now we're going to launch the minimal residual disease test.
Which will complement our full offering to oncology I hope that's clear.
Yeah, that's very helpful. Thanks, and then.
Lastly.
I heard a comment about a march.
March 20th year to complete.
Folio analysis, what would that be in rural Duffy.
I'll, let Gary responding is preparing to that.
Yeah, Hi, this is Gary in April and.
And we were planning to have the.
R&D day as a virtual event and it will be on March 20th.
Or in the afternoon, and it will be providing the specifics in terms of.
Logging in.
At that time, what Youll hear it you'll hear about the evolving portfolio.
Starting with the multi specific antibodies their.
Patients with solid tumors liquid tumors, we also will cover the infectious disease.
Portfolio HIV Sars Kobe too.
And.
In addition to that some work on others.
Emerging pathogen and then finally as early as described the <unk> vaccine.
What the status is of the programs and what the prospects are for the future So where we're really looking forward to sharing.
Our excitement about the portfolio and really the.
The advantages that our new technologies offer for a variety of diseases.
Just as an add on if you allow Mitch 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 and programs that are pretty much going through the last stages of IND approval.
Got it Okay. That's super helpful. Thank you and thanks for hopping on dairy.
Sure. Thank you.
The next question comes from Edward <unk> with Piper Sandler. Please go ahead.
Great. Thank you very much for the update and I'm really looking forward.
So your R&D day next month.
I guess my question has to do just with respect to <unk>.
Overseas and really Ho Hum and Kevin is doing.
Are you seeing competition at this point from the Sky, So far and how much of a delay do you think in terms of ultimate competitive competition in the U S.
There's the.
No head start.
Sky Trophy has gotten so much of a.
Oh no.
Setback do you think that might be for the ultimate marketshare.
Thanks, so much.
Hey, Todd, it's Adam I'll, I'll start off and I'm sure others will weigh in so outside of the U S right now.
At least in the Japanese markets.
Japanese region, we don't.
They expect long acting growth hormones to enter that market for a few years in Europe .
You know there is there is a head start that that Pfizer has had on on sky drove as well I think they've schedule won't be launched until the second half of this year in the European market. So so there is a good deal of progress that Pfizer has been able to make in that market.
As far as the U S delays go like you know there there's it's a big it's a big market payer landscapes are challenging for all new entrants into the market, which is which may have impacted the <unk>.
Launch, so we think pfizer's well positioned once they they do have approval to launch in the U S.
So we expect it to be a competitive market today, it's fragmented with seven 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.
In addition to the upside so we're all set boxes you huh.
One element that is important and that is if and when hopefully we get approval for.
For the FDA, our R&D expenses in Sumatra, Goggle claw it will decrease.
Decreased significantly because we're keeping the sites open.
Extensions so as long as we haven't finalized the approval of that so that will also help in the balance sheet. If you will have the program on that.
I don't think it's taken into accounts.
And maybe Adam can give you the numbers.
Eventually.
Okay.
I appreciate that color. Thank you.
The next question comes from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Good afternoon, and thanks for taking the questions.
My first question is in terms of our N. Gen law.
Uh huh.
Doctors selling in Europe , and that you will.
<unk> started to have a profit sharing later this year.
Do we anticipate either Pfizer or you've got some.
Sales figures over those territories.
In Q2.
To buy more colors.
Okay.
So Pfizer I don't know what their plans are to split out.
In general as <unk>.
Revenue numbers, so we wouldnt provide those when it becomes material to the overall financials of vodka, we would we would potentially break out the profit share of royalty royalty income that we're receiving from it.
And maybe a follow up question on this one missed that.
In the press release.
That there is.
All priority market.
To be launched this year.
Could we get a little bit more color in terms of what constitutes the priority markets and just a statement.
The major pharmaceutical markets is the way I would define it.
Okay, and maybe last question here in terms of the diagnostic sector.
Bruce.
Could we get some sense in terms of the head count.
From the height of the Kobe phase two recently as well.
How does that compare to the pre called new names.
Yeah, I can't I can't answer that question.
No.
At the peak of the Covid.
Basically at the end of 'twenty, one beginning of 'twenty two 8000.
Today, we're at 3300 <unk>.
Okay. How is that I also compared to the prior to Covid.
So instead of a thousand.
2019.
It was the same head count 3300.
Okay great.
Very helpful and thanks, and congrats on all the promises.
And we're still working and we're still working on it as Adam mentioned.
Okay.
Okay great.
Oh I'm sorry go ahead.
Just as long as we said to bring this to bring to bring the company back to profitability.
We are hoping to achieve another $30 million of efficiencies.
Thank you.
The next question comes from key 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 what sales up somewhat troubling you have received in the first quarter.
So we have not broken it out separately now.
Okay do.
Do you plan to do that at some point in the future.
Yeah. So once the number becomes a material number which you know you 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 on line.
And has further indicated whether when there will be an update regarding the U S. Resubmission could it be for first half of this year or second half of this year.
So nobody knows exactly when you'll Pfizer is a regular dialogue with FDA towards approval and we hope it to be first half of this year, but they haven't provided a specific date.
Okay.
Lastly, could you comment on the most recent trend.
I'll stick volume.
Specifically, specifically for non Covid tests, and whether use do you expect.
Diagnostics segment revenue you could resume growth in the first half of this year.
That's exactly what we're working on and it is actually.
Essentially the same level as two.
2019 base I'm talking about the core business at all.
And as Adam said, we're planning on that.
Growth of that core business at about three 4%, but the main.
<unk> is going to come from the specialty testing.
Testing as I described in oncology Urology Women's health and also large health systems.
Partnerships.
Okay, which is which is in the high single.
Low double digit range.
Alright, 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 Opco as you.
You've heard we are working on all fronts. There was great interest in the.
Progress over in Germany and.
Your questions about what's forthcoming in the United States.
Great interest of course, and you can be sure that Pfizer working with our team.
And address the questions that.
Were raised by the FDA and we hope that we think that they were answered in a very positive favorable way, we hope the FDA agrees.
Agrees with us and.
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 bio reference.
Business to bring it back to where it should be and where we think it will be and so far as reality is concerned we didn't talk much about it but you can be sure that we're working very hard to.
Increased revenues and profitability and we're enthusiastic about the work that our partners are doing on the product as well. So I'll leave you with that and our hope that as many of you as possible we will participate in the R&D and Bryan I'm on the 20th of March and it.
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.
Uh huh.
[music].