OPKO Health, Inc. (NASDAQ:OPK) Q2 2023 Earnings Conference Call August 3, 2023 4:30 PM ET
Company Participants
Yvonne Briggs – LHA Investor Relations
Phillip Frost – Chairman & Chief Executive Officer
Elias Zerhouni – President & Vice Chairman
Adam Logal – Senior Vice President & Chief Financial Officer
Conference Call Participants
Jeffrey Cohen – Ladenburg Thalmann & Co.
Yi Chen – H.C. Wainwright & Co.
Michael Petusky – Barrington Research
Yale Jen – Laidlaw & Company
Operator
Good day, and welcome to the OPKO Health Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note this event is being recorded.
I would now like to turn the conference over to Yvonne Briggs.
Yvonne Briggs
Thank you, operator, and good afternoon. This is Yvonne Briggs with LHA. Thank you all for joining today’s call to discuss OPKO Health’s financial results for the second quarter of 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. These 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 has subsequently filed SEC reports. This conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 3, 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. Philip 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 Health. After that, Adam Logal, OPKO’s CFO, will review the company’s second quarter financial results, and then we’ll open the call to questions.
Now, I’d like to turn the call over to Dr. Frost.
Phillip Frost
Good afternoon and thank you for joining us today. In June, we were pleased to announce what we had been expecting for more than a year. FDA approval of NGENLA our long-acting, once-weekly human growth hormone analogue to treat pediatric patients age 3 and older. Our global commercial partner, Pfizer, has indicated it expects NGENLA to become available this month for prescribing in the U.S. This approval triggered a $90 million milestone payment from Pfizer and leads to a profit-sharing arrangement that Adam will discuss in more detail. That decision by the FDA as to when was approvals in over 40 countries with commercial launches to date in over 18, including the major markets of Japan, Germany, France, Spain and the United Kingdom.
Pfizer expects to launch NGENLA in another 18 or more countries during the remainder of this year, covering all priority international markets by year-end. With the U.S. approval, we expect to see significant ramp-up in sales for NGENLA as market penetration continues to expand globally. With Pfizer’s global commercial infrastructure and long-standing experience in this particular market segment, we couldn’t have a better partner. On another front, we continue to advance the sophisticated science of our ModeX unit toward clinical trials. ModeX novel approaches are validated by the exclusive worldwide collaboration with Merck that we announced in March to develop our multivalent nanoparticle Epstein bar virus vaccine. Our strategy was to secure a large pharmaceutical partner to develop the EBV vaccine and we have a great one in Merck.
Despite the significant prevalence of this virus and its potential to cause head and neck, stomach and other cancers as well as multiple sclerosis, there are currently no FDA-approved vaccines for EBV. At BioReference Health, we continue to drive cost control efforts in parallel with work to enhance innovation and productivity. We look forward to our Diagnostics segments returning to profitability in the near future. Our international operations continue to perform well with both our Iberia American and CINtec [ph] businesses demonstrating profitability and growth this past quarter.
With that brief overview, I’ll turn the call over to Elias to provide further discussion and commentary on our pharmaceutical and diagnostic businesses. Elias?
Elias Zerhouni
Thank you, Dr. Frost, and good afternoon, everyone. As Dr. Frost just mentioned, we were extremely proud to announce the approval of NGENLA in the U.S. This long-acting treatment reduces the burden on children with growth hormone deficiency with injection frequency going from daily administration to once weekly.
Upon the upcoming launch later this month in the U.S., OPKO will be entitled to a profit sharing and management with Pfizer on a worldwide basis, which is based on regional tiered gross profit on both NGENLA and Genotropin, Pfizer’s daily human growth hormone. Now turning to ModeX, as mentioned by Dr. Frost, we are advancing our recently announced collaboration with Merck to develop our Epstein-Barr virus multivalent nanoparticle vaccine. This collaboration is significant and that it addresses an important unmet clinical need, but also validates ModeX’s innovative multi-targeting technologies. Our vaccine targets the 4 major Epstein-Barr virus proteins known to allow the virus to enter human cells. This multi-targeted approach holds potential to provide complete protection against this virus which affects up to 95% of the global adult population during their lifetime with over 200,000 cases of related cancers per year and a strong link to multiple sclerosis.
We’re now jointly working with Merck on IND-enabling studies to enter the clinic as soon as possible. In addition to the EBV vaccine, our antiviral program is focused on other indications, including the treatment and prevention of HIV and COVID-19. We have a partnership with the NIH to develop a tri-specific candidate to both prevent and treat HIV. And the NIH is providing funding for this program, which is in Phase I. In addition, we’re working on next-generation candidates that offer up to tenfold improvements in potency and greater breadth of antiviral activity against the majority of global HIV strengths. Current HIV medicines still have limitations, including drug toxicity due to lifelong therapy and drug resistance that can impact the efficacy of viral suppression.
Additionally, we’re working on the COVID multi-specific antibody program to address the emergence of resistant variants on a global basis. We believe the virus will remain in the human population for some time to come and will require novel therapies, especially for at-risk patients who have underlying medical conditions or a suppressed immune system. Since our technology platform is modular, it allows for the rational selection of antibodies to optimize potency against current and future strength and prevent the emergence of viral resistance. This program is partially funded by DARPA, and we are in late-stage preclinical testing. Recently, we applied for further funding from DARPA [ph] to support our COVID-19 multi-specific antibody program and platform as well as for seasonal influenza therapy and prevention.
Now on another side of our programs, our oncology program focuses on hard-to-treat solid tumors, but also the treatment of leukaemia and lymphoma. As you know, many cancer therapies still fail to achieve or maintain a positive response with a loss of tumor antigen expression as one of the main reasons. Our multi-specific antibody candidates are designed to engage and optimize T cell function while preventing tumor antigen escape. These programs are in the preclinical stage with plans to enter 2 programs in the clinic in 2024.
Moving now to RAYALDEE. Our treatment for secondary hyperparathyroidis [ph] in adults with stage 3 or 4 chronic disease, chronic kidney disease and low vitamin D levels. The numbers for the quarter break down as follows: the total prescriptions for Royalty in the second quarter of 2023, as reported by IQVIA, were approximately 13,100 representing an increase of 5.8% from approximately 12,385 in the previous quarter. Privately sales are steadily recovering from the impact of pandemic-related challenges in onboarding new patients.
Let me go now to our Diagnostics segment at BioReference Health, where our focus remains on improving the performance of the company following the major drop in COVID revenues by driving cost efficiencies by improving revenue cycle management and achieving volume growth and increasing market access with an ultimate goal of improving operating margins towards profitability in the upcoming quarters. Through these initiatives, we’ve been able to further reduce our workforce by 7% in the second quarter with more than 200 positions eliminated.
In the laboratories, we have realized further cost reductions by better reagent and supply pricing and utilization as well as streamlining management structures and operations. In regard to revenue cycle management, we’re improving the actual realization on our build services by increasing payer calves on access, enhancing our preauthorization procedures, reducing unbillable and introducing co-pay and point-of-care collections as well as bad debt collections. For example, our market access team has succeeded in negotiating contracts that will result in more covered lives and improved payer reimbursement. For example, we received the status of preferred lab network by United Healthcare for 2023 for the fifth consecutive year.
We reached a 3-year contract agreement with Humana, which includes reimbursement on the 4Kscore test and negotiated a new amendment with Cigna for additional CPT code coverage. We also reached an agreement with CareSource, which will open up the Ohio, Georgia, Indiana, Kentucky, North Carolina, Arkansas and West Virginia markets, among others. We have also reorganized our commercial team based on 3 regions: the Northeast, the Southeast and the West. The structure will allow us to more effectively address growth opportunities aligned with the local health care industry as local market conditions in each region.
We continue to focus growth efforts in specialty diagnostics and health systems with growing pipelines in both and begun to develop services for pharmaceutical industry clients. In oncology, for example, we’ve seen volume growth predominantly led by our molecular genomics Oncocyte and OncoCyte advanced portfolio, which have been well received and are growing in volume and scope of services. In women’s health, last quarter, we introduced CINtec PLUS cytology, which is the only FDA-approved 3-ish test that uses HPV dual biomarker technology to Triage women with HPV positive results with test orders steadily increasing in the second quarter.
We also continue to see strong volume growth at [indiscernible], a blood test that detects ovarian cancer risk and in women diagnosed with the pelvic mass, we have a planned surgery. Our urology segment remains focused on marketing our proprietary 4Kscore test, which now is included in the American Urology Association clinical guidelines for urologists. Our expanded health systems commercial team continues to build our hospital and health system business line by increasing our reach in hospital laboratory management, outreach and reference work, creating meaningful and collaborative solutions that address the challenges many hospitals and health systems are facing currently. In summary, as we keep a disciplined approach to improve margins performance, we’re seeing steady progress on our path back towards profitable growth.
I will now turn the call over to Adam Logal to discuss our second quarter financial results. Adam?
Adam Logal
Thank you, Elias. Starting with our Pharmaceutical segment. Revenue increased to $138.4 million for the second quarter of 2023 from $123.1 million for the comparable period of 2022. This increase reflects the $90 million milestone payment due from Pfizer related to the approval in the U.S. for NGENLA during the second quarter of 2023 versus $85 billion in milestone payments from Pfizer for the approvals of NGENLA in Japan and the European Union during the 2022 quarter as well as higher gross profit share payments from Pfizer during the quarter.
Revenue from RAYALDEE in our International Pharmaceutical businesses increased by $7.6 million, reflecting improvements in overall prescriptions and net price as well as gains from currency exchange in Chile and Mexico. Costs and expenses for our Pharmaceutical segment were $74.7 million for the second quarter of 2023 compared to $67.7 million for the 2022 period. Research and development expense for the second quarter of 2023 were $17.5 million compared with $14.8 million for the 2022 period. This increase reflects activities from our ModeX development programs, partially offset by decreased spending for our NGENLA development activities.
The resulting operating income for the quarter ended June 30, 2023, was $63.6 million, an $8.2 million improvement from operating income of $55.4 million for the second quarter of 2022. Amortization expense related to intangible assets was $16.5 million and $16.7 million, respectively, for the 2023 and 2022 quarters.
Moving to our Diagnostics segment. We reported revenue for the second quarter of 2023 of $127 million compared to $186.8 million for the 2022 period. This decline primarily reflects lower COVID testing volumes. As Elias discussed, our focus at BioReference remains to identify profitable growth verticals and to maximize operating efficiency. We’ve strategically invested in additional commercial resources in our higher-growth specialty verticals and expect to begin yielding returns on those investments during the second half of 2023. We continue to execute our reach expense reduction program at BioReference. And as Elias discussed, we also identified a number of near- and medium-term growth programs that we continue to expect through the balance of the year.
Operating expense for our Diagnostics segment was $44.3 million for the quarter compared to $57.5 million for the prior year. Amortization and depreciation expense included in operating loss were $8.6 million and $10.2 million respectively, for the 23 and 2022 periods.
Turning to consolidated financial results for the second quarter, we reported operating income of $7 million compared with an operating loss of $10.7 million for the 2022 quarter. Net loss for the second quarter of 2023 was $19.6 million or $0.03 per share. This compares to a net loss of $101.7 million or $0.14 per share for the 2022 quarter. Net loss for both periods was negatively impacted by the mark-to-market losses from GeneDx’ stock price decline of $19.9 million and $71.2 million, respectively, for the ’22 and ’23 periods.
As we look at the current quarter, we are providing financial guidance with the following assumptions. For our Pharmaceuticals segment, we have assumed the U.S. region for the for NGENLA will be in the gross profit share commencing in September as Pfizer’s U.S. launch is expected to begin in late August. During the first quarter of 2023, the European region shifted to a gross profit share. And going forward, both the European region and Japanese regions will result in gross profit share, consisting of GENOTROPIN and NGENLA. For the first 6 months of 23, Pfizer reported approximately $222 million of global GENOTROPIN sales. We assume a stable foreign currency exchange for our U.S. Pharmaceutical businesses.
We have seen a 10% favorable impact on our businesses over the last 12 months. For costs and expenses related to R&D, we expect to wind down the clinical operations of NGENLA for the pediatric indication as quickly as possible with final clinical site closure visits occurring now through the first half of 2024. The decreases are expected to be offset by increased R&D activities related to our ModeX development programs that Elliot discussed. Regarding the assumptions for our Diagnostics segment, we assume COVID testing volumes remain an insignificant portion of our overall testing volumes.
We have also assumed consistent core testing volumes with growth in our higher-margin oncology and urology specialty lines as well as a slight increase in the average per patient collection amount due to our revenue cycle management initiatives. As a result, we expect the following for the third quarter of 2023.
Total revenue is between $165 million and $180 million. This includes revenue from services between $126 million and $135 million; revenue from product sales between $32 million and $36 million and other revenue between $5 million and $10 million, inclusive of the estimated Pfizer gross profit share. We expect the Q3 23 costs and expenses to be between $240 million and $250 million, including R&D expense of $21 million to $24 million and depreciation and amortization expense of approximately $26 million.
That concludes our prepared remarks. Thank you all for your attention. And now operator, let’s open the call for questions.
Question-and-Answer Session
Operator
We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Maurice Raycroft from Jefferies.
Unidentified Analyst
This is Kevin [ph] on for Maurice. Congrats on the quarter. First question on the Nigel profit share. I know you mentioned that this would come about likely in September. Do you know when we could get more details on the agreement there? And then, also your latest thoughts on when we could break out the Nagano revenue.
Phillip Frost
Thanks, Kevin, for the question. So we guided the total revenue coming from the profit share lines to be between $5 million and $10 million for the third quarter, which is pretty conservative given that the Pfizer is really just going to start launching in the U.S. region in the next couple of weeks here. So as that continues to develop, we’ll provide some better purviews into that. But I think from our overall guide, we’ve talked about the total potential opportunity is significant. Just in these early days, it’s difficult for us to be very specific on how Pfizer is going to launch the product.
Unidentified Analyst
Okay. Yes. And then, just one on the diagnostics business. So you mentioned returning to profitability in the near future. Are you guiding more specifically in that regard in terms of maybe by the end of this year or by early next year? And then also in terms of returning to profitability, are you also guiding to return to growth as well?
Phillip Frost
Elias, I don’t know if you want to go with any comments that I can add in…
Elias Zerhouni
Well, yes, sure. I mean our plans are to basically reach breakeven by the end of the year, beginning of 2024, and then have profitable growth in 2024. The question you asked about growth is obviously the key to the success here is continuous growth. So yes, we’re not depending just on cost reductions. We are also — as Adam mentioned, we have made investments actually in the commercial realm and in focused new verticals, like the pharmaceutical industry, which I know well, which is a launch potential, I believe, and we’re working on it as well as the health systems business line.
Phillip Frost
Yes. So maybe I’ll just add on our guide here. We guided $126 million to $135 million against the second quarter, which reported $127 million. So from that perspective, Kevin, we do see there is some upside here in the near term and hope to Ellis’ point, continue to build on that into the future quarters.
Unidentified Analyst
Makes sense. Thanks.
Operator
Our next question comes from Jeffrey Cohen from Ladenburg Thalmann.
Jeffrey Cohen
Thank you all for taking our questions. Firstly, Adam, could you break out for us service revenue, the cost of service revenue and the cost of product revenue, I actually see your Quest momentarily.
Phillip Frost
Yes. So the queue is out there. I can break it down for you, Jeff, if you need.
Jeffrey Cohen
But it’s in the queue, yes.
Phillip Frost
Yes, it’s in the K [ph].
Jeffrey Cohen
Okay. Perfect. And could you talk anyone there a little bit about the ovals test and perhaps some of the traction or pricing or geographical presence that you’re generating thus far?
Elias Zerhouni
Yes. Plus is growing quite a bit. And basically, in our catchment area at this point, where our sales force is present and our women’s health presence is strong. I cannot give you specific numbers, but I can certainly follow up with you on that.
Jeffrey Cohen
Okay. That’s helpful. Any commentary specific to RAYALDEE, I saw 7.7% for the quarter. Any outlook or guidance there on revenues or prescriptions or growth?
Phillip Frost
So we didn’t get go specific, but it has continued — Elias had called out the year-over-year prescription growth of just below 6%. So I think we’re continuing to see that build. Consistent with prior years, we see the net reimbursement improve throughout the year for RAYALDEE. So we should see continued growth sequentially, but we didn’t call it out any specific pit there.
Elias Zerhouni
Just a little clarification. It was 6% quarter on previous quarter, Q2 over Q1, not previous year.
Jeffrey Cohen
Okay, got it. That’s helpful. And I see it in the Q, the revenue from services and products broken out. That’s helpful. And — any commentary on margins? Should we expect with some cost reductions to see margins improve on the service side over the balance of this year? Or that’s more of a 24 issue?
Elias Zerhouni
We’re working on improving the margins this year. I mean, as you know, I just mentioned, we’ve reduced headcount by 7%. We’re looking at multiple areas where margins need to be improved. We have renegotiations with payers as well and pricing reviews as well as contribution margins for you. So my expectation is to narrow the margins — improve the margins to narrow and get to breakeven, hopefully, at the end of the year, beginning of first quarter — or first quarter 2020.
Jeffrey Cohen
Okay. And then lastly, Adam, okay, for us to use on the cash, the $101 million plus the $90 million expected this month, I think.
Elias Zerhouni
Yes, that’s right.
Jeffrey Cohen
Okay, perfect. That’s it for us.
Phillip Frost
Thanks, Jeff.
Operator
Our next question comes from Yi Chen from H.C. Wing.
Yi Chen
Just shape on behalf of you can ones all the progress. My first question is on ModeX. Any color on the type of cancer indications that you would like to target next year in the Phase I.
Elias Zerhouni
So we have two programs that are the most advanced. One is for solid tumors. And it’s going to be tested against the basket of solid tumors to try to see where we get the most response. So the solid tumors, the prostate cancer, gastric cancer, pancreatic cancer and non-small cell lung cancer. So I can’t tell you which one will emerge or which once will emerge, but that’s the trust of the program on solid tumors. And then we have a program on more liquid tumors, leukaemia’s and lymphomas, which is a parallel program that also will emerge in the clinic, hopefully, as early as possible in 2024, but we think by the end of 2024, we’ll have two programs; two cancer programs in the clinic.
Yi Chen
And the other thing on your diagnostics business. I know you mentioned some of the cost-cutting steps in your prepared remarks. And I’m sorry if I missed it, but could you highlight some of the other growth initiatives that you have planned for that business unit? I know you mentioned a few is there any important ones that need to know?
Elias Zerhouni
So I mean, basically, we’re doing a full review of the business and its mechanisms. So in addition to cost reduction, we are also looking at revenue improvements on the business we have, all right? So that’s the revenue cycle management initiative. And that actually is quite promising because it turns out that if you look at the way we were capturing revenues, we had quite a significant loss in terms of billables due to incomplete CPT codes, ICD telcos and preauthorization, which is a common strategy that payers are using. So we put countermeasures to that, and it’s paying off. In addition, the company never really focused on point-of-care collections like copay. And if you look at the number of successions we do, just capturing a few dollars makes a huge difference. So that’s, if you will, on rightsizing the spend versus collections that we make, okay?
The second major thrust is obviously growth. When you look at the growth, we’ve grown in oncology. We’ve grown in women’s health, and we continue to focus on the specialty services. The one that’s emerging and we made some announcements, I hope, over the next few weeks is large systems that really are facing very difficult margins. And we, for example, manage now the Westchester Medical Center laboratories and capture an increasing share of the outreach business with that. And we are essentially increasing the funnel. We increased our sales force in that category from 1, 2 salespeople before to 5, 6 today. And we’re focusing on the regional approach because — as you probably know, the situation of hospitals and the need for laboratory management, outreach services reference is very different from region to region. And so we are definitely looking at growth in the specialty businesses and the health systems, and that’s ongoing.
And we started a new line of potential revenue, which is the pharmaceutical business, given the fact that we have a laboratory, which can do actually biomarker research as well as data that is very valuable to pharmaceutical biotech companies. We’re exploring that, obviously, I cannot quantify it at this point, but it’s certainly a promising line based on my knowledge of having been a head of R&D and a major pharma company, I know that there is a huge need for that of having a reliable laboratory that supports clinical trials and development as well as research. So those are the multiple lines of activities we’re pursuing on the large front. And I would say, so far, so good.
Yi Chen
Excellent. Thank you and congrats, again.
Operator
Our next question comes from Edward [ph] from Piper Sandler.
Unidentified Analyst
My congratulation on NGENLA approval, very exciting. And I know it’s been a long path coming. So that’s great to see. My question actually I just had a real quick housekeeping one. Adam, I missed what you said, I think it was about R&D, maybe ’24. What is the top end of the guidance?
Phillip Frost
It’s ’21 to ’24.
Unidentified Analyst
’21 to ’24, not that possible. And then also just a quick accounting question. I don’t believe so for the guidance that you mentioned, but the $90 million milestone won’t be recognized in the P&L in any way. It’s really just going to go straight to the balance sheet.
Phillip Frost
So it was in the P&L in Q2, and it’s — so we have a receivable recorded for it. We’ll get the cash.
Unidentified Analyst
Or I didn’t see that yet awesome. Great. Very exciting. And looking forward to seeing growth from that product and also great progress in the ModeX work. So, thank you.
Operator
Our next question comes from Michael Petusky from Barrington Research.
Michael Petusky
So Adam — and I may have missed this if you reminded people earlier, but what’s the cost takeout so far at BRL to this point?
Adam Logal
Yes. So far this year, it’s — we had set a target of about $40 million, and we’re about at the halfway point for that, probably a little bit ahead. Elias, I don’t know if you have the specific number. But I know as last week, we tracked it; it was just beyond the halfway point there with more to go for the — throughout the rest of the year. That is correct.
Elias Zerhouni
And remember, we took out $100 million before that.
Michael Petusky
Okay, all right. So given that, and I just flipped through the Q, I mean, it looks like you lost $44 million at the operating line in that business, which was actually sequentially worse than Q1. And it just feels like you’re nowhere close to being sort of on track to get to breakeven in that business by year-end. Can you sort of bridge — I’m hearing the growth programs and the continuing expense reductions. But like where does that — how does that happen?
Elias Zerhouni
Well, I think that the — maybe Adam can tell you some of the numbers in Q2 have onetime expenses due to reduction in people. And you have — as the Warn act, you have to have onetime costs accounted at the time you do that. So the figure that you’re mentioning is a little bit inflated because of these onetime actions that we took to reduce costs, which are costly and themselves. But it’s a onetime item. So if you really correct for that, you’ll see that the progress is much greater than that. And then when you look at the Q3, Q4 and Q1 ’24 because I can’t tell you what will band. We basically have to achieve a $10 million to $12 million plop closing between the revenue line and the expense line. And we think we can restart both on the reduction of cost, which we have clear line of sight of what we need to do, plus increasing capture of revenues of the existing business, as we speak. And the third is obviously the growth — the profitable growth that we are trying to not only grow but also refine and direct towards higher contribution margin business lines.
Phillip Frost
Yes. So I’ll just add in, Mike, if you don’t mind. So there’s a couple of additional things to think about. So Eli has talked about some of the revenue cycle management initiatives that are going on at BioReference. And those are, of course, dropped straight to the bottom line. So there’s not a significant cost takeout associated with those. So as we make good progress on those, we’ve initiated a significant number of the programs in the first half of the year and expect to start to realize the benefits from that as the year continues to progress. The early days, as Elias mentioned, have shown promise. So assuming we continue to execute there, that’s one area.
The volume growth that we’re targeting to also bring us in line is needed. You know as well as I do, that BioReference in any lab business is very, very fixed cost in nature and you’ve got to bring volumes in to absorb those fixed costs. So the incremental contribution for an additional dollar of revenue is it absorbs or so is absorbed into the fixed cost structure and only 20% variable cost. So, meaningful contributions from the growth initiatives that that Elias walked through earlier.
And then finally, the — we also talked about the nonrecurring costs that occurred during the second quarter and really in the first half of the year as we rightsize the organization, we’re going to see those benefits as we continue on a monthly basis throughout the remainder of the year.
Michael Petusky
Could I just ask you, so on the sort of that onetime nonrecurring stuff, I mean if you were to give yourself full credit for that, is the 44 really something closer to 30 or 35 or like the loss at the operating line. I mean what magnitude are we talking about in terms of nonrecurring?
Adam Logal
During the second quarter, we didn’t get the benefits from the nonrecurring cost because most of them came in late in the second quarter, but it’s in the magnitude of about $8 million on a gross basis.
Michael Petusky
So that takes you down to 36. I guess let me ask this question. What level of revenue do you have to be at based on what you think you take out in terms of costs and the benefits of revenue cycle management? What level of revenue do you have to be at, at the end of this year, early next year in that business to sort of be breakeven? What is the top line growth assumption that gets you there?
Adam Logal
Yes. So it comes — again, it’s not just volume, Mike. So volume growth has got to come, but the dollars associated with the growth is probably more important to get us to breakeven. So it’s going to depend on how successful we are on each of those programs. we would sit back and say if we can achieve our guidance that we’ve provided at the top end of our guidance that we provided in this quarter and continue to see that level of growth, it will get us to breakeven, as Elias mentioned, late fourth quarter, early first quarter.
Michael Petusky
Have to be sort of a $600 million annual run rate?
Adam Logal
That’s right.
Michael Petusky
All right. That’s helpful. I really appreciate it.
Operator
Our next question comes from Yale Jen from Laidlaw & Company.
Yale Jen
And I apologize, I came in late. So if some of the questions has been answered apart for reasking that. So my first question is in terms of NGENLA in terms of the revenue going forward, when you guys may be able to start to bring it to a separate line in reporting from the P&L?
Phillip Frost
Yes. So Yale, thanks for the question. Again, we — once it becomes material, we’re going to start talking about it. It’s in the $5 million to $10 million guide that we had for our other revenue line, so it’s included in there, so you can get the scale. We think with Pfizer’s launch coming in the next couple of weeks, it could be as early next quarter that we start breaking it out. But at this point, we haven’t.
Yale Jen
Okay, great. And maybe just one more question here in terms of mode — the collaboration with Merck for the vaccine. Could you give us a little bit update in terms of where things are? And is there any projections as when this might start the human studies?
Elias Zerhouni
Thank you. So with Merck, we’re working very well and collaborating, I would say, in a very effective way. As you know, we received an upfront payment and Merck covers the cost of our current work, which is designed to bring to the product to an IND together. There are some unknowns that relate to the choice of adjuvant for the vaccine that we need to test out. Those can be short or can be 6 months, I don’t know. That’s the unknown. But clearly, if you look at the natural evolution of such a program, we should be in the clinic by next year, for sure, in my mind. But this is plus/minus 6 months or plus/minus 3 months depending on how things are going, but it’s going well. So that’s what we’re hoping for to get it to the clinic as soon as we can.
Yale Jen
Okay, great. Well, I appreciate it. And again, congrats on the progress and look forward to speaking with you guys soon.
Operator
This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Phillip Frost for any closing remarks.
Phillip Frost
Well, I’d like to thank you all for attending the conference, and we look forward to meeting with you again at the end of next quarter. Thank you again.
Operator
The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.
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