OpGen Inc (OPGN) 2021 Q2 法說會逐字稿

Welcome to the OpGen Second Quarter 2021 Earnings Call and Business Update. (Operator Instructions) As a reminder, this conference call is being recorded today, August 12, 2021.

Before we begin, I'd like to caution you that any comments made during this conference call by management may contain forward-looking statements regarding the operations of and future results of OpGen, including its subsidiaries, Curetis and Ares Genetics. I encourage you to review OpGen's filings with the Securities and Exchange Commission, including, without limitation, the company's most recent Form 10-K and 10-Q for the second quarter of 2021 that will be filed with the SEC, which will identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

Factors that may affect the company's results include, but are not limited to, our ability to successfully achieve the expected synergies from the company's completed business combination with Curetis, to implement the combined company strategy, the impact of the continuing global COVID-19 pandemic on our business and operations, our use of proceeds from recent financings, pursuit of FDA clearance for the Acuitas AMR Gene Panel for use with bacterial isolates and for our other products and services, the rate of adoption of our products and services by hospitals and other healthcare providers in general as well as in the current COVID-19 pandemic situation in particular, the success of our commercialization efforts and partnering strategy, the effects on our business of existing and new regulatory requirements and other economic and competitive factors.

The content for this conference call contains time-sensitive information that is accurate only as of the date of this live call, August 12, 2021. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call, except as required by law.

Joining the call today will be Oliver Schacht, President and CEO; and Tim Dec, CFO of OpGen.

I would now like to turn the call over to Oliver Schacht for introductory remarks.

Thank you, operator, and thank you, everyone, for joining us this afternoon. As always, we appreciate your continued support of OpGen. We're very pleased with our second quarter performance and strong momentum through 2021. We'll focus on our firm progress within our diversified portfolio of products, combined with our growing partnerships. We look forward to increased activity in our pipeline in the near future as we continue executing on our strategy of becoming a leader in the molecular diagnostics and bioinformatics industry.

On today's call, we'd like to begin with a recap of highlights briefly mentioned on the first quarter earnings call, followed by recent updates in our product and R&D pipeline. I'll then pass the call over to Tim to review financial highlights from the second quarter. We'll then wrap up the call with an outlook on the company's upcoming milestones, followed by a Q&A session.

In our previous earnings call, we announced results from the very well attended multi presentation webinar titled Pneumonia Diagnosis: Bacterial Superinfection in COVID-19 Patients. Professor and senior consult physician, Christian Giske, at the Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden, highlighted several important findings from his study, including key advantages of the Unyvero HPN panel compared with conventional bacterial culture.

Professor Giske concluded that the Unyvero demonstrated higher diagnostic yield, specifically 25.3% more detections than bacterial culture, including several key pathogens of concern, notably S. maltophilia was called out as an important target on the Unyvero panel because of its intrinsic resistance against many of the standard antibiotics. An analysis of chart reviews of patients that had multiple lower respiratory cultures ordered during the course of their hospital stay reveals 2 clinically important cohorts. In group one, culture and Unyvero HPN results were 100% concordant on the first and all subsequent samples that had been ordered. The findings in this cohort demonstrated that Unyvero HPN would enable significantly more rapid detection of pathogens not covered by empiric therapy due to intrinsic resistance within 5 hours as opposed to 2.5 days by culture.

In group 2, Unyvero HPM detected bacterial pathogens up to 7 days earlier in patient samples that were initially negative by culture, but subsequent cultures ordered during hospital stay were confirmed as positive for the same pathogen at a much later stage. As a consequence of lack of finding antimicrobial etiology by culture, this group of patients was exposed to longer duration of empirical antibiotic treatment. The second presentation focused on a number of clinical cases from the Unyvero LRT BAL study that exemplify the performance characteristics and potential clinical impact of this Unyvero panel in pneumonia diagnostic algorithms, presented by Drew Bell, medical and public health microbiology fellow at Indiana University School of Medicine.

An analysis of retrospective chart reviews performed on patients suffering with various types of pneumonia as well as non-pneumonia patients revealed that based on conventional microbiological results, 41% were undertreated, 19% were overtreated, while only 25% were appropriately treated and 16% were appropriate without antibiotic treatment. In contrast, the study demonstrated that using the Unyvero LRT BAL panel would have enabled prompt and appropriate targeted antibiotic therapy in 41.3% of cases, including escalations and de-escalations, reducing the time to appropriate therapy by 25.7 hours.

Additionally, we previously touched on our extended collaboration with the New York State Department of Health through September 30, 2021. The partnership extension remains valued up to an additional $540,000, which includes a monthly retainer based project fee as well as volume dependent per test fees. The extension period gives us the time to discuss and evaluate potential future forms of collaboration with the New York State Department of Health across the state. We've seen nice levels of increased testing volumes throughout the second quarter, and we hope to continue and expand our relationship with the department. To that end, the dialogue with the New York State Department of Health is already ongoing.

In June, we submitted an updated 510(k) summary to the FDA for our Acuitas AMR Gene Panel for Isolates. The FDA had previously provided substantive feedback on what we believe is all key documents, including the package insert, electronic user guide and operator manual, in line with their currently expected time line of doing so by the end of May.

The FDA recently reiterated to us that it intends to complete its review by the end of August of 2021. Since submitting our revised documents to the FDA, we have not received any additional feedback nor questions or requests for additional information. Although the FDA clarified that their time lines can be affected by various factors, we're confident in the progress moving us much closer towards reaching a final FDA clearance decision point in the coming weeks based on the FDA's current expected time line.

Recently, we successfully completed the move of our U.S. headquarters, labs and operations to a new facility here in Rock Hill, Maryland. The 10,000 square foot facility results in net savings of approximately $600,000 annually and operating efficiencies and reduced rent. Going forward, all Unyvero cartridges as well as Acuitas consumables for the U.S. will be stocked and shipped directly from this facility.

Regarding Ares Genetics, Ares has recently signed several additional collaboration agreements. For example, one with UPMC in Pittsburgh, Pennsylvania. We're in a scientific and clinical collaboration project, we will be working on nanopore technology-based approaches. Furthermore, Ares has entered into a strategic R&D collaboration with a major U.S.-based CRO and reference lab. As part of that collaboration, Ares has the right to select a large number of key isolates for sequencing and data curation, thereby significantly expanding the Ares database content and scope as a leading database of AML markers and AST data. In return, Ares will provide certain next-generation sequencing services and its AI-powered predictive AST capabilities to the partner lab.

Also during the second quarter of 2021, Ares amended its licensing agreement with QIAGEN to now allow for nonexclusive access to research use only of the ARESdb and thereby opening up the path to adding further collaboration partners for global research users off the platform. The collaboration with Sandoz has been extended and expanded once again in Q2, and we also expect further projects and collaboration opportunities to be added to the Sandoz partnership during the second half of 2021.

Several additional collaborations are currently at various stages of negotiations with pricing discussions ongoing on some of these. Dr. Johannes Weinberger, NGS Lab Director, recently provided an update on our culture free genomic assay for AMR surveillance. Dr. Weinberger spoke via virtual presentation at a conference sponsored by Twist Bioscience. Dr. Weinberger commented that, I quote, the sensitivity for AMR marker detection in native urine samples from septic patients with confirmed mono infections in Ares study was determined to be between 94% and 100% when compared to comparator data obtained from whole genome sequencing of the corresponding bacterial isolate.

On day 2, after the Twist Bioscience conference, Dr. Arne Materna, CEO of Ares Genetics, presented virtually at the Genomics-Track discussion at the Amazon Web Services Healthcare and Life Sciences Symposium. Dr. Materna discussed at the Ares Universal Pathogenome Assay, Ares UPA, is currently being evaluated in a paid-for early access program for which Ares has already signed up 5 public health organizations from different European countries.

We further extended our R&D updates through 2 virtual seminars where Dr. Materna presented preliminary data of an ongoing multicenter validation of long rate nanopore sequencing of clinical isolates. We're conducting the multicenter validation by Oxford Nanopore Technology, or ONT, in combination with Ares cloud for data analysis. Ares Cloud assisted conversion of ONT data into clinically and epidemiologically relevant information proved highly accurate for participating labs, with average accuracies of consistently 100% for pathogen identification, up to 97% for AMR marker detection, and again, up to 100% for predictive antimicrobial susceptibility testing or AST.

As a result, we're planning to assess the performance and utility of ONT-based isolate sequencing for clinical routine use in collaboration with a major U.S. academic hospital. The results from the multicenter validations and subsequent clinical study are targeted to be published in a peer-reviewed scientific journal to expand the workflow adoption and laboratories worldwide. We're extremely pleased with the progress of Ares Genetics to commercialize solutions for pathogen and AMR surveillance and are excited by the opportunity to continue developing additional new partnerships with more organizations, both in the United States and overseas.

Continuing with more recent presentations and conference attendances, we'd like to note a few highlights. The company announced positive prospective clinical data on the Unyvero LRT BAL at a webinar at the end of June, titled one academic medical centers experience with the Unyvero multiplex platform for testing bronchoalveolar lavage fluids, analytical and clinical assessment, which study patients in the intensive care unit for whom BAL specimen was ordered for diagnostic purpose and prospectively evaluated with the Unyvero LRT BAL panel in conjunction with quantitative bacterial culture and antimicrobial susceptibility testing. The clinical impact of the Unyvero results on antibiotic stewardship and patient management were discussed and acted upon in real time, enabling earlier adjustment of antimicrobial therapy in 53% of all cases.

At the World Microbe Forum, Dr. Drew Bell of Indiana University School of Medicine reported in an i-poster titled, Clinical Evaluation of a Multiplex Molecular Diagnostic Lower Respiratory Tract Panel for Bronchoalveolar Lavage Specimens, which demonstrated that the Unyvero LRT BAL provided the basis for appropriate escalation and de-escalation of antibiotic therapies in 42% of cases, reducing time to appropriate therapy by 31 hours.

Dr. Cory Hale, Infectious Disease Clinical Pharmacist at the Penn State Health Milton as Hershey Medical center in Hershey, Pennsylvania, present on Unyvero LRT titled Antimicrobial Stewardship Opportunities Using Results from a Multiplex Molecular Lower Respiratory Tract Panel as Compared to Conventional Culture. Their data characterized the potential impact of Unyvero LRT on antibiotic therapy in patients being treated for pneumonia. Retrospective chart reviews were performed in 92 of these patients, including 51 critically ill ICU patients and 39 pediatric patients. They reported complete agreement between Unyvero LRT and culture results in 50% of cases and in 45.7% of cases, Unyvero yielded more information than culture alone.

In addition, 2 posters on the Acuitas AMR Gene Panel for Isolates were presented at the conference by the Wadsworth Center, New York State Department of Health and their participating sites. The first poster titled Combating Antimicrobial Resistance in New York State with Public Health Partnerships, highlighted the collaboration project between the Wadsworth center and option as part of the New York State Life Science initiative to demonstrate the benefit of a rapid molecular diagnostic assay in identifying relatedness of antimicrobial resistant organisms indicative of outbreaks or transmission.

The second poster titled Comparative Analysis of a Carbapenemase Producing Clips Yellow Pneumonia Outbreak in a New York state healthcare facility using multiple typing methods, investigated a large outbreak of carbapenamase producing carbapenem resistant enterobacteriaceae at a healthcare facility detected through the AR Laboratory Network. The investigation concluded that the Acuitas AMR Gene Panel produced highly concordant results with whole genome sequencing and that these findings can be used to improve infection control practices in this and other facilities. This type of data provides us the evidence basis for a highly focused and targeted commercial launch campaign once we have obtained FDA clearance for the product.

Curetis successfully completed and assembled a batch of 10 final pre series release Unyvero A30 RQ analyzers. The Unyvero A30 RQ platform is designed to deliver rapid and multiplex testing results in under 30 minutes for some assays and in 45 to 90 minutes for more complex samples. The platform has also been designed for competitive mix of features, such as its multiplexing and rapid time to result, optional quantitative assays where needed, all at very favorable cost of goods for both the instrument system and the single-use cartridges. This is a major development milestone in the Unyvero A30 program as they are now available for final verification and validation testing.

Such V and V testing is actually already underway as we speak, with a focus on mechanical and electric functionality as well as lifetime testing of the instruments. Aligning with our sales and partnership strategy, the Unyvero A30 platform can be made available to third-party development and commercialization partners and licensees for their own assay menu and product portfolio. Discussions are currently ongoing with several potential platform partners for various content and licensing or partnering scopes.

Finally, we'd like to make a quick note that our U.S. sales force has expanded through the recent hire of Derek Joesting, Senior Vice President of Sales. Recently, Mr. Joesting led the North American expansion for genetic signatures and was focused on expanding the North American sales team and identifying and driving new business opportunities. Prior to that, Mr. Joesting was instrumental in the early success of T2 Biosystems, building and leading the sales team to launch their first FDA-cleared products. His 20 years of diagnostics and medical device sales experience include molecular diagnostic sales leadership and pathology sales leadership as well as sales experience in diagnostic imaging, anesthesia, oral surgery and ophthalmology. We couldn't be happier with the addition during such an exciting time in the company's history, and we have full confidence that Mr. Joesting's ability to complement our growing team. In fact, Mr. Joesting has already further expanded our U.S. sales team with an additional Regional Business Development Director who had previously been responsible for the Northwest territory at BioFire.

We're currently looking to add an additional regional business development team member in the southwest to complete and round out our combined Unyvero and Curetis U.S. sales team.

I'll now turn the call over to our CFO, Tim Dec, who will review financial results for the second quarter. Tim?

Thank you, Oliver. On today's call, I will briefly touch on the highlights of the second quarter, discuss our balance sheet position and review underlying growth drivers for the business. Revenue for the second quarter of 2021 was $811,000, down 32% from $1.2 million for the prior year period. Even though revenue for the quarter was down, it is important to note why. Laboratory service revenues increased approximately 926%. The increase is primarily attributable to the inclusion of $200,000 of lab service subsequent to the transaction, including COVID testing services performed by the company's Curetis subsidiary.

The increase in laboratory service revenue was offset by the following. A decrease of product revenue of approximately 49%. The decrease is primarily attributable to a decline of $300,000 due to the strategic exit from the company's fish business and a decrease in collaboration revenue of approximately 58%. The decrease is primarily attributable to a decline of $300,000 due to the conclusion of a nonrecurring completed R&D collaboration project with an IBD partner at Ares Genetics in 2020.

Revenue for the first half of 2021 was $1.6 million as compared to $1.8 million for the first half of 2020. This decrease is primarily due to a change in revenue from the various product offerings. The company had a decrease in product revenue of approximately 14%. The decrease is primarily attributable to a decline of $400,000 due to the strategic exit from the company's fish business, offset in part by a $300,000 increase due to the inclusion of Curetis product sales subsequent to the transaction.

The company also had a decrease in collaboration revenue of approximately 56%. The decrease is primarily attributable to a decline of $500,000 due to the conclusion of a nonrecurring R&D collaboration project with an IBD partner at Ares Genetics in 2020. These decreases were offset in part by an increase in lab revenue service. The increase is primarily attributable to the inclusion of $400,000 of laboratory services subsequent to the transaction, including COVID testing services performed by the company's Curetis subsidiary.

Operating expenses for the second quarter of 2020 were $7 million compared with $7.7 million in the second quarter of 2020. Operating expenses for the first half of 2021 was $14 million as compared to $12.3 million for the first half of 2020. Net loss for the second quarter of 2021 was $7.1 million or $0.19 per share compared with $7.5 million or $0.49 per share in the second quarter of 2020. The net loss for the first half of 2021 was $21.9 million or $0.65 per share as compared with a net loss of $11.4 million or $1 per share for the first half of 2020.

Our cash position as of June 30, 2021, was $31.2 million. As a reminder, our cash position was bolstered this year as a result of a $25 million registered direct offer in February of 2021 at a strong price point and the warrant exercise in exchange of $9.7 million in March of 2021. Our Q2 2021 cash burn was higher than the normal of $5 million to $6 million per quarter due to 3 items that all occurred during the second quarter and are not expected to occur again until Q2 2022: our annual D&O insurance renewal of approximately $800,000, our annual debt interest payments to EIB of approximately $900,000 and 2020 staff bonuses of approximately $700,000 paid in Q2. Total shares outstanding as of today are approximately 38.3 million shares and the fully diluted number of shares as of today would be 49.3 million shares.

As Oliver mentioned in his prepared remarks, there are a number of near-term and long-term milestones that the company is working very diligently on achieving. On August 5th, we determined to cancel the reconvening of the adjourned portion of our annual meeting of stockholders for the consideration of proposal 2, relating to the increase in the company's authorized shares of common stock. In order to provide the most strategic financial flexibility to the company, we filed $150 million S-3 shelf registration this past Monday. This filing does not constitute any offer at this time, but the Board and senior management at OpGen will continue to evaluate various alternatives for financing the future development and growth of OpGen over the coming months and quarters.

As previously mentioned on our first quarter earnings call, due to the ongoing challenges presented by COVID-19 pandemic, we will refrain from any specific revenue guidance today. However, we are excited by the recent development progress in both the Curetis Unyvero A30 RQ platform and Ares Genetics progress on multiple fronts in strategic partnering as well as the commercial launch efforts of our service offerings, such as the Ares ISS and Ares UPA. We are actively capitalizing on our breakthroughs and are determined to continue our momentum through increased collaboration and partnership efforts.

I would -- I'd also like to note that it comes with bittersweet emotions that as of August 2021, I'll be stepping down as Chief Financial Officer and Corporate Secretary of OpGen. I have a huge amount of respect for our leadership team, management and all of our employees. I am confident in their ability to continue to provide a strategic focus, the necessary support required and continue to drive shareholder value.

With that, I'll turn the call back to Oliver.

Thanks, Tim. As a personal note, myself and the entire leadership team and Board of OpGen are hugely appreciative of the great work you've done in recent years for OpGen and your leadership can bring in OpGen and Curetis together and completing the integration following last year's business combination. Knowing that it will literally be just 2 floors upstairs is great and I wish you all the best for your new endeavor at Supernus.

I would now like to talk about the company's recent and upcoming milestones. As stated earlier and on last quarter's call, we have submitted an updated 510(k) summary to the FDA for our Acuitas AMR Gene Panel for Isolates. We remain confident that OpGen has addressed all of the FDA's comments and edits to date. The FDA has previously stated that they "expect to complete the review by the end of August 2021". Although the FDA said that their time lines can be affected by various factors, there have been no changes or amendments to the previously established time line and we continue to expect to see a completed review by the aforementioned date.

We delivered on our previously stated guidance and expectation to complete a batch of 10 final pre series Unyvero A30 analyzers. I can't stress enough how proud I am of the Curetis team achieving such an impressing milestone on time and within budget, despite headwinds from COVID-19, global semiconductor shortages and other supply chain issues. It's a testament to their flexibility and hard work, and it illustrates that our team can continue to execute and put our best foot forward while facing deep global challenges.

We recently received additional feedback via our Chinese partners at Beijing Clear Bio from the Chinese regulators at NMPA, that the NMPA is asking for some supplementary clinical data on the Unyvero pneumonia cartridge to be generated in China and submitted to the NMPA to address affinity and prevalence differences in the U.S. and European data. Thus far, we're talking about a small-scale study of maybe around 600 samples to be tested. Together with BCB, we're working on the next steps in logistics to ensure a swift execution of such a study, and we'll be providing further updates in due course.

In closing, we're pleased with our R&D advancement and milestone achievements over the last few months. We'd like to thank all of our employees. Tim and I, along with the rest of the management team, are deeply appreciative of your continued commitment. Your dedication is integral to our success. To all our listeners, we're looking forward to updating you as we progress on our partnership strategy, R&D pipeline and pending clearance decision from the FDA as well as subsequent commercial launch of the Acuitas AMR Gene Panel here in the U.S. heading into the third quarter of 2021. As always, thank you for your unwavering support and for participating in this afternoon's call.

I would now like to turn the call back to the operator for questions. Operator?

(Operator Instructions) We'll take our first question from Ben Haynor with Alliance Global Partners.

First off for me, just on the BCB and the NMPA supplemental data that you need to be generating. It doesn't sound like it's going to take a long time to test 600 samples, but do you have any indication on how quickly the NMPA might be able to turn that around once you do submit the data that they've requested?

So you're absolutely right. I mean especially looking at the size and scale of some of these AAA hospitals in China and the high prevalence of pneumonia as a disease, we would anticipate enrollments for such a small supplementary study to be relatively short, definitely not more than a couple of months. Now the NMPA, however, at this point still does not provide any clarity or guidance on their review time lines thereafter. They have, however, reviewed all of the submission data that we have provided from our FDA data, from our European data, from the data that has already been generated in China, and this is sort of the ancillary or supplementary dataset that they're asking for. So they're not going to be starting the review, but they're literally going to look at this incremental and supplementary dataset.

Okay. So that doesn't sound really all that bad, but I suppose you never know when you're dealing with any government agency. And then just -- I apologize if you mentioned this, but just on the studies, the FDA studies for the UTI and IJI panels, did you guys give an update on the time lines there? Or are we still looking sometime later this summer for UTI and later this year for IJI?

Yes. So good question. I didn't specific comment, but we're absolutely on track with both clinical trials in terms of the preparation. The UTI trial sites here in the U.S. are currently seeking IRB approvals and final clinical trial agreements are being reviewed by legal and finance, and we expect to get the UTI trial off to a good start here in the coming weeks. We already have sufficient instrument systems, Unyvero instruments here in the U.S. We're preparing large batches of UTI cartridges on the manufacturing side for the trial. And so everything is progressing as planned, on track and no changes thus far.

Great. And then on some of the clinical data that's come out here recently on LRT BAL, 53% earlier adjustment of antimicrobial therapy, escalation -- appropriate escalation, de-escalation in 42% of the cases, that seems like you're changing the therapy decision quite a bit. You do hear about other companies and similar studies saying all well, we alter therapy, 12% of the time or 26% of the time. Is there kind of a threshold that hospitals and facilities like to see before they even take a look at evaluating something in terms of alteration of therapy or because I would think half the time would get everyone's attention pretty quickly?

It sure does. And you're absolutely right. I mean when you look at a lot of the literature and preconceived notions, probably people say, well, maybe it's 10% of cases, 15% on the outside. But we're seeing this time and time again specific to pneumonia, which again is a critical disease and the current standard of care based on empiric broad back -- broad spectrum antibiotics is simply inadequate in a lot of cases. What we've seen with these datasets is a lot of kind of not just raised eyebrows, but really sort of aha moments where clinicians, pharmacists and lab folks in some of the major hospitals that have generated -- these have gotten together, have pushed for some strong support towards their own hospital administration.

So clearly, this type of data is extremely supportive of getting not only clinicians attention but also the sense that, look, if we're inadequately trading half of our patients, I mean that's a real problem. It's a problem clinically and from a patient management, but it's also a problem from any quality management metric, from potential readmissions and CMS financial penalties. And the economics, if you look, and we've significantly spent time and energy working with several of these hospitals on some health economic modeling. And you look at some of that modeling, it typically takes -- and again, it depends a bit on specific DRG coding and case numbers per hospital. But typically, anywhere from the mid-to-high single-digit percentage into the very low double-digit percentage health economically, you have a clear justification.

So if you're in the 40%, 50% and this is economically a great support. So we're definitely excited by the data. We have an upcoming webinar on September 14, which we'll look at a study from Europe, which was an interventional trial, multicentric, that looks, again, at sort of the clinical impact that Unyvero pneumonia testing can make. And again, I'd just encourage everybody to listen into that because it's some really exciting data that speaks volumes to the problem and the solution that's right available.

Yes, it's very intriguing for sure. And then lastly for me on the Ares signing up, I think you said 5 public health organizations in different European countries. Obviously, OpGen already had the New York State Department of Health agreement. It sounds like there's kind of -- you guys are going to kind of have like an offering or almost a package that you'll be able to offer to other organizations and jurisdictions in public health. I mean is that a fair assessment? Or what's the right way to think about it if not?

Absolutely. I mean whether it's the Acuitas AMR Gene Panel for Isolates, which is very much focused on infection prevention and sort of public health monitoring. The Ares Genetics next-gen sequencing base is also very attractive as a tool, and you could potentially even imagine, as you said, packaging or combining some of these offerings. So yes, I mean, it is a strategic focus, bringing these types of solutions to public health institutions. And if we look forward here into the third and fourth quarter, in addition to these 5 public health institutions, the Ares Genetics team is already engaged with several national reference laboratories across Europe on several specific pathogens of concern that these national reference labs are responsible for.

So again, you can definitely anticipate seeing more of that strategically getting the solutions into the hands of public health institutions, public health labs and then gradually moving from there into more patient-focused routine -- clinical routine, if you will.

Moving now, we'll go to Yi Chen with H.C. Wainwright.

This is [Chi] on behalf of Yi Chen. I noted in your prepared remarks, you said you can't really get into the details of revenue expectations. But maybe help us understand maybe some of the key catalysts or the key events that drive revenue expectations for the coming quarters? And specifically, if you could comment on the trend of operating expenses, that would be very helpful.

Let's start with the operating expenses. I think if you look at our G&A, R&D as well as marketing and sales that have been extraordinarily consistent quarter-over-quarter, the guidance we've provided previously, and we definitely stand by that here today, is we're not expecting any significant changes. So we expect consistency in the third, fourth quarter and moving into early parts of next year on that sort of breakdown. I would say on the revenue side, you will continue to see that gradual shift as we move through the year. Quarter-after-quarter, we'll have the fish business drop out. We completed and exited that, as we said in our previous earnings call, at the end of Q1. So there will be no fish revenue and that was just short of $2 million last year. That will be, over time, compensated by growing service revenue on the one hand, and that's services from the Ares Genetics offerings that we've just been discussing as well as some ongoing service offerings on the COVID testing side.

But the real focus here is going to be on product sales and the key milestones here, I mean obviously, being able to get back into hospitals and labs for the Unyvero, we've already seen a number of new and additional placements with some clinical reference labs here in the U.S. for the urinary tract infection. We've expanded that installed base here in the second quarter. I expect that to continue. And we also expect to drive forward with the clinical and commercial implementation at several of these institutions that have presented this great data. We now have that support and backing.

So product revenue on the Unyvero side growing. Service revenue growing on the Ares Genetics side. There's a couple of unknowns here. The current extension of the New York State Department of Health Project runs through September 30. And as I commented, there's obviously the desire on all party sides to continue and think about extending and expanding that. But so far, we have obviously not signed anything or announced, but that's something to look for from the fourth quarter this year and onwards. And the obvious commercial catalyst here on the Acuitas AMR Gene Panel is FDA clearance. Again, just to remind everybody, we have already manufactured multiple batches of product. It's sitting here in Rockville on the shelf. We're waiting for the final FDA clearance to be able to fix the final labels and basically start rolling out and launching that product.

And then the other significant catalyst commercially will be China. And again, looking at those time lines, clearly we're pushing forward as aggressively as we can to make sure that that supplementary study gets done and gets done swiftly. And then once that approval comes through and the launch happens, again over an 8-year period, up to $180 million, but even in the first year, it should add materially to the top line revenue, both on instrument sales as well as pneumonia cartridge sales. But that's really the focus.

U.S. direct sales on Unyvero, lower respiratory track as well as UTI, continuing the distribution business in Europe internationally, China and then Ares Genetics. The other -- if you want to look at it as a potential catalyst, and there are certainly a few of them, is partnering deals. And we have repeated and reiterated today that we are engaged with multiple parties around the Unyvero A30 platform. Depending on the structure of such a deal, if you think about a classical licensing deal that may have elements such as an upfront license or technology access fee, it may or may not involve ongoing collaborative R&D funding. It may have certain milestones and then potentially future royalties. It's obviously difficult to project until you actually know the details of any such partnership, how the revenue recognition pattern from those types of deals would materialize into quarterly earnings.

And the same holds true for any potential future deals with Ares Genetics. Again, they've continued to add deals, both with existing partners. They've added new partners, and it's our clear intention to continue adding strategic partnerships. And as I said, we have several specific proposals for collaborations and licensing opportunities from our genetics in front of several interested parties. And again, it will depend on the specifics of the deal, whether it's upfront lump sum payments, ongoing payments, royalty payments, revenue recognition on these will be hard to predict, and it will always be lumpy and deal driven. But of course, from a cash flow perspective, any of these deals have significant potential to provide non-dilutive cash and capital to OpGen.

(Operator Instructions) Moving on, we'll go to Max Jacobs with Edison Group.

Actually, most of mine have already been answered. So I just was wondering what's the status of the New York Department of Health partnership. I know it expires on September 30, so just some of the negotiations to go past that.

I'd venture, I guess, that the state of New York probably currently has bigger issues. But in all seriousness, this was a program that the previous governor had a strong interest in. And at the Wadsworth there and at the New York State Department of Health, there is genuine and strong interest. They have gone through a lot of the data that has been generated already. They're working very closely with the 3 -- in addition to Wadsworth as the state's lab, they're working with the 3 major labs, the Northwell, NYU and Mount Sinai labs that have, if you remember, more than 35 affiliated hospitals that are feeding into that system.

And we're working with them to really pull out and help in the interpretation of the impact this type of data can have on public health in terms of outbreak tracing, tracking and monitoring. So we've certainly made it clear from OpGen's perspective that, to us this is not a research interest per se. We're interested in driving this into clinical use and clinical routine, and we're a commercial enterprise. So they full well understand that in order to keep the sort of metaphorically, keep the lights on in the lighthouse that we have deployed across the state.

There needs to be an agreement and that in an ideal world should be in place no later than October 1. From pre-risk experience with the state, they're a very reliable and constructive partner. Their legal team is not always the fastest. So we'll see where that stands. But again, all parties are genuinely working towards figuring out what the best path is here and I'm not going to speculate on what that deal may look like. But as soon as we agree and put something in place, we'll obviously let everybody know.

That's all the time we have today. I will now turn the call back over to Mr. Schacht for any closing remarks.

Well, again, thank you, everyone, for joining us today. Please visit our Investors section on our website for all of our SEC filings for updates on the company. Really appreciate you taking part and thank you very much.

Thank you. And that does conclude today's conference. We'd like to thank everyone for their participation. You may now disconnect.