ImmunoGen Inc (IMGN) Q4 2022 Earnings Call Transcript

ImmunoGen Inc (NASDAQ:IMGN) Q4 2022 Earnings Call dated Mar. 01, 2023.

Corporate Participants:

Anabel Chan — Head of Investor Relations

Mark Enyedy — President and Chief Executive Officer

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Renee Lentini — Interim Chief Financial Officer, Chief Accounting Officer, and Vice President, Finance

Todd Talarico — Interim Chief Commercial Officer and Vice President, Market Access

Analysts:

John Newman — Canaccord Genuity — Analyst

Michael Schmidt — Guggenheim — Analyst

Etzer Darout — BMO Capital Markets — Analyst

Boris Peaker — Cowen and Company — Analyst

Andy T. Hsieh — William Blair & Company — Analyst

Kelly Shi — Jefferies & Company, Inc. — Analyst

Asthika Goonewardene — Truist Securities — Analyst

Daniel Wolle — JP Morgan Securities — Analyst

Jonathan Chang — SVB Leerink — Analyst

Peter Lawson — Barclays — Analyst

Presentation:

Operator

Good morning, and welcome to ImmunoGen’s Fourth Quarter and Full-Year 2022 Financial and Operating Results Conference Call. Today’s conference is being recorded.

At this time, I’d like to turn the call over to Annabel Chan, Head of Investor Relations. Please go ahead.

Anabel Chan — Head of Investor Relations

Good morning, and thank you for joining today’s call. Earlier today, we issued a press release that includes a summary of our recent operating progress and fourth quarter and full-year 2022 financial results. This press release, a recording of this call and an updated corporate deck can be found under the Investors and Media section of our website at immunogen.com.

With me today are Mark Enyedy, our President and CEO; Anna Berkenblit, our Chief Medical Officer; and Renee Lentini, our Interim CFO. Michael Vasconcelles, our EVP of Research, Development and Medical Affairs; and Todd Talarico, our Interim-Chief Commercial Officer will join us for Q&A.

During today’s call, we will review recent accomplishments for the business, our financial results and highlight upcoming anticipated events.

We will be making forward-looking statements based on our current expectations and beliefs. These statements are subject to risks and uncertainties, and our actual results may differ materially. Please consult the risks outlined in our press release issued this morning in the Risk Factors section of our most recent annual report on Form 10-K and in our other SEC filings, which are available at sec.gov and immunogen.com.

With that, I’ll turn the call over to Mark.

Mark Enyedy — President and Chief Executive Officer

Thanks, Anabel. Good morning and thank you for joining us today. 2022 was a landmark year for ImmunoGen with significant progress on multiple fronts highlighted by the approval and launch of ELAHERE as the first and only ADC for the treatment of platinum-resistant ovarian cancer encouraging data from our second pivotal program, PVAC advances in our early stage programs, including reaching the recommended Phase 2 dose for 936 and initiating Phase 1 development with 151, rebuilding our rebuilding our pipeline through collaborations with Oxford BioTherapeutics and Biocean [Phonetic], and strengthening our management team with Michael Vasconcelles in a newly created role as Executive Vice President, Research, Development and Medical Affairs; and Daniel Char, as General Counsel.

In addition, this morning, we were pleased to announce a global multi-target license and option agreement with Vertex. We are excited to partner with a leader in transformative medicines and believe this deal nicely reflects our continued innovation in the ADC space and demonstrates the value of our technology platform and related intellectual property.

With the momentum generated over the last 12 months, we look forward to a number of important milestones in 2023 that will include building on the strong start to the ELAHERE launch, about which I’ll have more to say in a moment, reporting data from our confirmatory MIRASOL trial and submitting regulatory filings to support full approval of ELAHERE in the EU and U.S., sharing ORR data from PICCOLO in platinum-sensitive disease, completing enrollment in our pivotal BPDCN study and updating data from expanded frontline cohorts in AML with PVC and reporting top line data from the expansion cohorts with 936. So we’re proud of what we accomplished over the last 12 months and look forward to an exciting and productive year ahead as we grow our business, drive value for shareholders and deliver more good days for patients.

So just a few qualitative updates on the ELAHERE launch. We are now just three months in and seeing strong performance across each of the key imperatives we set for the business. First, uptake has been broad and deep. As a reminder, our first patient was treated on December 1, and we generated $2.6 million in net sales for the quarter, nearly all of which came in December. Through the end of 2022, roughly 70% of our orders came from nonacademic settings and 75% of our orders from accounts with no prior ELAHERE experience, which is a strong indicator of the breadth and depth of adoption. In the new year, revenue growth has accelerated as we are seeing a significant percentage of accounts, with repeat orders complementing new patient starts.

Turning to testing. Strong demand continues for the full R1 diagnostic through the four central labs set up in collaboration with our CDx partner, Roche. In addition, we’re also seeing new labs request certification to run the test in-house, which we believe is another favorable sign of physician and patient interest. Through the end of 2022, we estimate that roughly 1,500 tests have been performed, and that volume has increased as we have moved into the first quarter. Consistent with our education efforts, we believe a significant percentage of these tests are being ordered for newly diagnosed patients. While these patients are not eligible for treatment with ELAHERE today, this will enable oncologists to rapidly incorporate ELAHERE into their future treatment decisions. In addition, our tracking indicates that FR alpha positivity rates remain consistent with our clinical trial experience of between 35% and 40%. Regarding coverage, we’re again off to a fast start in terms of access with a growing number of national and regional payers, including ELAHERE on coverage policies aligned to our label. Recall that as of early January, 18% of Medicare and 25% of commercial lives recovered, driven by the efforts of our access team, coverage has rapidly increased this quarter. We were also pleased to see ELAHERE was added to the NCCN guidelines in December as both monotherapy and in combination with bevacizumab.

Finally, our customer-facing teams are highly active in terms of reach. As of the end of December, our commercial and medical teams have connected with 70% of their priority targets, with these numbers continuing to increase in the new year. Finally, our teams report that feedback from medical experts and clinicians for ELAHERE has been enthusiastic, and we are leveraging these customer insights to ensure positive physician and patient experiences as we move forward.

So as you can see, we’ve made strong progress in the early months of launch and are excited about this momentum through the rest of the year and look forward to reporting the quantitative metrics for the first quarter during our next earnings call.

With that, I’ll turn the call over to Anna to provide additional color on our ongoing development programs. Anna?

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Thanks Mark. We are thrilled with ELAHERE’s accelerated approval and excited by the early feedback we are receiving in the field from health care providers. We’re pleased that data from the SORAYA study, which supported ELAHERE’s accelerated approval were published in the Journal of Clinical Oncology in January.

In February, the safety and efficacy data of MIRV in combination with bevacizumab in platinum-resistant ovarian cancer, which supported its inclusion in NCCN guidelines, were published in Gynecologic Oncology. We look forward to an active year ahead, including the presentation of additional efficacy data from SORAYA by sequence of treatment as well as the final overall survival analysis at SGO later this month in Tampa. While it has taken a little bit longer than anticipated to reach the requisite number of PFS events, we will imminently reach the 330 PFS events needed to trigger the primary analysis in the confirmatory MIRASOL trial, and we now expect to announce top line data in the second quarter. Based on the totality of data generated with ELAHERE today, we are excited about the prospect of this trial, demonstrating improvement over investigators’ choice chemotherapy and supporting full approval of ELAHERE in the US, and submission of an MAA in Europe.

Let me now turn to the broader MIRV development program, which has the potential to meaningfully expand the ELAHERE label. In January, we completed enrollment in Piccolo, our single-arm study of MIRV monotherapy in recurrent platinum-sensitive ovarian cancer patients with high FR alpha expression. We expect data on the primary endpoint of ORR before the end of this year. As we look to position MIRV as the combination agent of choice in ovarian cancer, we are progressing two studies. The first is our Phase 3 GLORIOSA study evaluating MIRV plus bevacizumab maintenance versus standard of care bevacizumab maintenance in the second-line platinum-sensitive setting. With the robust data we’ve generated for this combination in the platinum-resistant setting supporting NCCN compendia listing, we are excited to move this combination up into the platinum-sensitive setting where patients have the potential to benefit from even longer treatment duration. The second is trial 420, a single-arm Phase 2 study evaluating mirvetuximab plus carboplatin, followed by mirvetuximab continuation in platinum-sensitive ovarian cancer patients with low, medium and high levels of FR alpha expression. Both trials are up and running in the US, with enrollment having begun in Study 420, and we are actively working on opening both studies in Europe.

In parallel with the significant advances we have made on the MIRV program, we are also pleased with the recent progress of PVAC in both BPDCN and AML. As you may recall, we previously aligned with FDA on a pivotal frontline cohort of up to 20 patients in our Phase 2 CADENZA study as a path to full approval, with CR/CRc as the primary end point and duration of CR/CRc as a key secondary endpoint. In an initial analysis of data from this study, we were encouraged with the activity seen in both de novo and PCHM patients, or patients with a prior or concomitant hematologic malignancy, with 11 of 13 or roughly 85% of patients achieving some form of complete response.

In discussion with FDA, we aligned with the primary efficacy evaluable population will be in de novo BPDCN patients. Enrollment in CADENZA has increased following the release of these initial data, and we expect to complete enrollment before the end of this year and report top line data from the de novo cohort in 2024. In AML, we presented, as part of our fourth consecutive oral presentation at ASH, promising efficacy data findings from dose escalation and expansion cohorts of the 802 study. This Phase 1b/2 study is evaluating PVAC with venetoclax and azacitidine in patients with relapsed/refractory and frontline AML. This novel triplet showed manageable safety profile and strong anti-leukemia activity, with an objective response rate of 45% and composite complete remission or CCR rate of 25% in our expanded relapsed/refractory cohort.

We observed compelling CCR rates across various relapsed/refractory patient subgroups. And importantly, in our initial frontline cohort, 50% of patients achieved a CR. Based upon the encouraging results from these first 10 frontline patients enrolled, we have moved forward rapidly with gathering more data for the triplet using 14 days of venetoclax and recently completed enrollment of this cohort. Separately, we are seeing strong recruitment in a second cohort of up to 50 frontline patients with the goal of evaluating up to 28 days of the venetoclax per cycle to optimize the duration of therapy. Tolerability and efficacy outcomes from these cohorts will guide pivotal development of the triplet in frontline AML.

In addition, our recently announced clinical collaboration with Gilead will evaluate the safety and anti-leukemia activity of PVAC in combination with magrolimab and will comprise a new cohort of up to 42 patients with relapsed/refractory CD123-positive AML in the 802 study. We plan to initiate, this new cohort in our ongoing 802 study later this year, with complete response rate as the primary endpoint.

Turning now to the rest of the pipeline, we’ve completed dose escalation with IMGC936 and are focused on expanding to non-small cell lung cancer as well as triple-negative breast cancer. We look forward to sharing data from the Phase 1 dose escalation and our initial experience on these expansion cohorts in Q2 of this year. In addition, we advanced our Phase 1 study of IMGN151, our next generation FR alpha targeted ADC by dosing our first patients in January and look forward to continuing patient enrollment this year. So, great progress in 2022 and we’re looking forward to an eventful 2023.

With that, I’ll turn the call over to Renee to cover the financials.

Renee Lentini — Interim Chief Financial Officer, Chief Accounting Officer, and Vice President, Finance

Thanks, Anna. For the full year 2022, we generated $108.8 million in revenue, including $76 million of license and milestone fees, $2.6 million in net product sales of ELAHERE, and the remainder from non-cash royalty revenues. Operating expenses were $329.5 million comprised of $213.4 million of R&D expenses, compared with $151.1 million in 2021 and $116.1 million of SG&A expenses compared with $43.8 million in the prior year. We ended 2022 with $275.1 million in cash on the balance sheet.

Turning to our financial guidance for 2023. We expect revenues excluding product revenue from ELAHERE to be between $30 million to $35 million and operating expenses between $310 million and $320 million. We expect to provide ELAHERE product revenue guidance later this year. Excluding anticipated ELAHERE and collaboration revenue, our level of cash and cash equivalents as of December 31, 2022 alone is not sufficient to meet our current operating plan through March 1, 2024. With the addition of forecasted ELAHERE product revenue and milestone payments under existing collaboration agreements, we expect these amounts combined with existing cash will fund operations for more than 12 months, from the date of this release and we intend to raise additional funds through equity, debt or other financings.

With that, we’ll open the call for questions.

Questions and Answers:

Operator

Thank you. [Operator Instructions] Our first question comes from the line of John Newman with Canaccord Genuity. Your line is now open.

John Newman — Canaccord Genuity — Analyst

Hello, guys. Good morning. Thank you for taking my question. I just want to confirm on the top line data readout from MIRASOL that, will of course include the mature PFS data as expected. And some information on overall survival, which I believe you previously said would be immature, but you’d follow long-term. Also curious on the ELAHERE launch, just wondered what you’re seeing here in terms of combination use with Avastin at the moment? Thanks.

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Yeah, so John, you’re right that our primary PFS analysis were imminent in terms of triggering it based on the 330 requisite events. And when we have top line data, we will share PFS data. We will also share initial OS data. In terms of the level of maturity of OS data, we anticipate that there will be probably about greater than 60% of the overall survival events. So while it’s not the final OS analysis, we anticipate that the OS data will indeed be mature enough for regulators to understand the benefit of mirvetuximab and then of course we will have the final OS analysis later when we hit the requisite number of events for that.

Now I’ll turn it over to Todd.

Todd Talarico — Interim Chief Commercial Officer and Vice President, Market Access

Yeah. Thank you. John, at this time from an Avastin combination, approach where you don’t have the data yet to really evaluate the utilization of ELAHERE as a monotherapy or in combination, but as we get additional patient data, we’ll probably have a better idea of that in the next quarter or so.

John Newman — Canaccord Genuity — Analyst

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.

Michael Schmidt — Guggenheim — Analyst

Hi, guys. Thanks for taking my questions. I had one regarding the upcoming PICCOLO data later this year. Just wondering how we should think about the regulatory bar in terms of response rate. I think in the platinum-resistant setting, we’ve talked about the 12% hurdle rate for chemotherapy. Is that similar in the platinum-sensitive setting for PICOLLO? And then circling back to 936, I know you’ve talked about presenting data in the second quarter from dose escalation, early expansion cohorts. Just wondering if you could give us some more color on the sort of the quantity of the data, how many patients are in the expansion course at this point. Thanks so much.

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Sure. So in terms of the regulatory bar for recurrent platinum-sensitive ovarian cancer, and I would say, later line patients, so with two or more priors, there is no clear bar, unlike in the platinum-resistant setting where we aligned with FDA as you pointed out, on 12% based on multiple Phase 3 trials with investigator choice chemotherapy. In the later line recurrent platinum-sensitive setting, this is an evolving, emerging and growing unmet need with more patients falling into this category after having had a prior PARP inhibitor as maintenance. Recent data have shown indeed that PARP inhibitors may result in cross resistance, so that even if patients technically have platinum-sensitive disease, they may not be as sensitive as they were previously, in the pre-park days, if you will. And so while there are some studies out there that we can use, both in terms of platinum and nonplatinum-based combinations, particularly in patients with BRCA mutations, which are only about 20%, 25% of patients, we have a sense of what the efficacy is, but we would really need to engage with FDA on what the bar would be. And all I can say is the greater the activity of mirvetuximab in the PICCOLO study, the easier that conversation will be.

Moving to your second question on 936, we do anticipate sharing data in Q2 on the findings from dose escalation. So we’ll be able to talk about dose escalation, the recommended Phase 2 dosing schedule and a little bit of color about how we got there. And then we’ll be able to provide initial data on expansion cohorts in triple-negative breast cancer and non-small cell lung cancer. I think we’ll be able to share sufficient data on triple-negative breast cancer. We may hold off on sharing data from lung cancer — from non-small cell lung cancer because we like what we’re seeing so far, and we might just want to continue enrolling before we give a complete view of those data.

Michael Schmidt — Guggenheim — Analyst

Thank you.

Operator

Thank you. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is now open.

Etzer Darout — BMO Capital Markets — Analyst

Great. Thanks for taking the question. One for me, maybe a little bit too immature given your earlier commentary. But just wondered if you had a sense sort of the percentage of patients that are being given ELAHERE pre-bevacizumab. And any color on the ELAHERE sort of patient experience for those patients given sort of mirvetuximab, pre-bev and again, I think that kind of goes around sort of getting to the relative unknown, if you will, from MARISOL outcome. And if you could kind of gain any incremental insights into that based on patients given that the drug sort of pre-bev versus post bev?

Mark Enyedy — President and Chief Executive Officer

Yeah. Let me start the answer and then I’ll ask Todd if he wants to add any color. So as Todd alluded to, our best available data will come from evaluating claims data. It’s very early in terms of the generation of those data from the external sources. And so for example, while we do see mirv-bev use, for example, sort of trying to fix the percentage given the early days of the data inputs, I think, would not be productive. Similarly, looking at the question of whether a patient has received prior bev, again, too early to tell. But what I would say is the feedback that we’re getting from the field anecdotally continues to be highly enthusiastic in terms of the use of the drug and managing patients on an ongoing basis.

As I mentioned, we see an increasing percentage of repeat orders to complement the new patient starts, which is encouraging. And we are in very close contact with the accounts as new patient starts through ophthalmology referrals and then any follow-up questions, starting with this basic thing is infusion to manage events as we go forward. So from a quantitative perspective, as I say, the data — the claims data are just too early to give kind of definitive guidance in terms of breakdown of combo versus mono and where the line of treatment is and what the prior treatments were.

Etzer Darout — BMO Capital Markets — Analyst

Got it.

Operator

Thank you. Our next question comes from the line of Boris Peaker with Cowen. Your line is now open.

Boris Peaker — Cowen and Company — Analyst

Great. Thanks for taking my questions. I want to focus on the screening folate receptor alpha. You mentioned earlier that about 1,500 patients were screened that would have been like in the last month of the year. Can you comment how many patients have been screened since the time or maybe in ’23? And also, you mentioned that many of the tests are being done in newly diagnosed patients. Can you mention why are docs doing this if they really don’t have a therapeutic option based on this test for newly diagnosed patients?

Mark Enyedy — President and Chief Executive Officer

Yeah so what I can say about testing is that the rate has increased since the — so we basically did 1,500 tests in the first six weeks from approval through the end of the year, and that the testing rate has increased as we moved through the first two months of 2023. And we’ll provide hard data when we have the next earnings call in terms of the actual quantity of test.

In terms of why does the physician want to assess FR alpha status in a newly diagnosed patient, what we see from this physician group is they’ve become very accustomed over the last several years, initially looking for BRCA mutations and more recently for homologous recombination deficiency to really understand the genetic profile completely of the tumor. And so the adoption rates, quite candidly, and for newly diagnosed patients have exceeded our expectation. And it is because of the way in which this physician base has evolved in terms of their initial work of the patients. And so — and the other thing it does is, it reduces any delay in terms of making a prescribing decision. So once they know that they’ve got an FR alpha positive patient, if that patient progresses to — within our label, there’s no need for a subsequent test. They can use the previously available data and advance the patient on to ELAHERE immediately.

Boris Peaker — Cowen and Company — Analyst

Great. Thank you very much for taking my questions.

Operator

Thank you. Our next question comes from the line of Andy Hsieh with William Blair. Your line is now open.

Andy T. Hsieh — William Blair & Company — Analyst

Great, thanks for taking our questions. I have one about maybe potentially detecting on OS signal for MIRASOL. I remember the PS2 plus [Indecipherable] was pretty provocative from FORWARD I, and that was over a little bit — it was a little bit over 100 patients versus 450 with MIRASOL, so just trying to understand the ability to detect that signal?

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Yeah, thank you Andy. So your memory is absolutely correct. In FORWARD I, we had actually quite a strong trend even in the 10 times, if you will, for alpha high patients favoring mirvetuximab in overall survival. And in the PS2 plus, so the properly identified FR alpha-high patients, there was a very nice signal for OS favoring mirvetuximab over investigator choice chemotherapy. You’re right, in a relatively small subset, and it was post-hoc. And so, all of these reasons make us confident that overall survival in MIRASOL will trend strongly in favor for mirvetuximab over chemotherapy, and my prior point that we’ll have greater than 60% of the events. So the OS data will be relatively mature and interpretable at the time of the primary PFS analysis is important. You’re right, we enrolled a little over 450 patients. So the study does have reasonable power to detect a statistically significant improvement in overall survival, but we do not need that for regulatory approval, either in the US or Europe. No drug in ovarian cancer has been approved based on an overall survival benefit. So as long as we see a positive trend in the right direction, we’ll be fine. And there is a chance we could hit statistical significance. Again, the stronger the OS data, the easier the conversations are in Europe, particularly around payers and access and the value proposition.

Andy T. Hsieh — William Blair & Company — Analyst

That’s very helpful. And maybe from a modeling perspective, looking at the GLORIOSA study, I’m just curious, how should we think about the performance in terms of PFS for the Avastin control arm?

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Yeah, so that’s a good question, Andy, and it’s not one that can be easily answered based on the data from published studies looking at the triplet in and of itself, because the PFS data from, say, the OCEAN study and the GOG 213 study is counted from the date of randomization for the triplet and then continues on, including the triplet duration and then as well as the Avastin maintenance component. So our study, you may remember, we randomized patients at the time of maintenance. So any patient, as long as they have not progressed, will be randomized to MIRV BEV versus BEV maintenance. And so with that, we’ve worked with our statisticians to do some modeling. And I think it’s clear we have a very clear understanding of that. That has guided the sample size and the hazard ratio etc. that we have used to design the study. I think we’ll leave the details for that for another time. But I think the important point is that for those patients who have not progressed, Avastin maintenance has modest efficacy. And I think with mirvetuximab plus Avastin, based on the strength of our doublet data, we anticipate a long progression-free survival.

Andy T. Hsieh — William Blair & Company — Analyst

Thanks. That’s helpful. Thank you so much.

Operator

Thank you. Our next question comes from the line of Kelly Shi with Jefferies. Your line is now open.

Kelly Shi — Jefferies & Company, Inc. — Analyst

Thank you for taking my questions. This is a follow-up regarding the OS data to be released at the MIRASOL update. Just curious, you just mentioned the OS benefit will not be the basis for the full approval discussion. I’m curious that in the case if the median PFS benefit is less than 1.5 months over chemo, would the regulatory agency put more weight on evaluating less benefit? Thank you.

Anna Berkenblit — Senior Vice President, Chief Medical Officer

So Kelly, I really can’t answer your question because the point estimate for the median, if the point estimate for the medians are less than 1.5 months, that doesn’t tell me the totality of the treatment of mirvetuximab over investigator choice chemotherapy, where hazard ratio is the most appropriate statistical measure. And so, what I would say is we anticipate a statistically significant improvement in progression-free survival with a p-value less than 0.05. And the point estimates for the median for each arm will be what they will be. And then overall survival will certainly be part of the overall assessment that FDA does when they look at benefit risk.

Kelly Shi — Jefferies & Company, Inc. — Analyst

That’s helpful. Thank you.

Operator

Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is now open.

Asthika Goonewardene — Truist Securities — Analyst

Hi, good morning guys and thanks for taking the questions. Quick one on the ELAHERE commercial rollout [Indecipherable] suggested that one of your diagnostic vendors, NeoGenomics, has some issues with processing, and this was causing some delays in [Indecipherable]. But as far as we understand that these issues have recently been resolved. I just want to confirm that this is indeed the case and that there is, no testing bottlenecks now? And then related to that, was the $30 million to $35 million guidance of ELAHERE sales for this year based on sales made during that period when you had this bottleneck or is it purely taking into account the more recent run rate? And then I have a quick follow-up?

Mark Enyedy — President and Chief Executive Officer

Yeah, so no bottleneck in testing. All four of the central labs are up and doing very robust business. The fourth lab is a small regional lab in Las Vegas. But the three key labs, which include Labcorp, NeoGenomics as you mentioned, in cares, are doing large volumes of testing, and there’s no bottleneck. We’ve not given revenue guidance for ELAHERE, and we’ve deliberately done that given the early days of the launch. Obviously, many of you have provided your own estimates, and we look forward to reporting out data on a quarterly basis as we move forward. What we’re trying to do with you is give you a qualitative assessment of how the launch is proceeding based on what we think are the important metrics.

And so, as we’ve discussed, testing has exceeded our expectation. Adoption in the community has exceeded our expectation. Our academic accounts are our largest accounts, as we would have anticipated. And we continue to work nicely through the coverage decisions, and we started with a strong base at the beginning of this year, and Tom and his team have done an exceptional job in terms of improving both our Medicare and commercial coverage. The engagement with the compendia has been positive to include the combination. So all of the things that we would hope for, as a new entrant in the market have materialized nicely and our goal ultimately is to report out the quantitative metrics to go along with these qualitative in regular order with — in connection with the next earnings call.

Asthika Goonewardene — Truist Securities — Analyst

Okay, great. Just my quick follow-up then is of the 1,500 diagnostic tests that were — patients that were screened, and maybe if you can give any color on more recent numbers, too. About what percentage of them were from patients who are currently on a first or second line therapy for ovarian cancer? Just trying to see there’s a way for us to back out what the more immediate pent-up demand could be? Thanks.

Todd Talarico — Interim Chief Commercial Officer and Vice President, Market Access

Well, we don’t exactly know at what state each patient is at. I think what we found in the beginning was that we did have a lot of patients that were waiting for this product. So the testing early on was directly related to a platinum-resistant patient that was due to move on therapy. But as Mark alluded to earlier, the testing has been shifting and physicians are moving earlier, and practices are moving earlier to earlier diagnosis. And so, really difficult for us to determine the actual place in therapy for when the testing actually occurred.

Asthika Goonewardene — Truist Securities — Analyst

Thanks, guys. I appreciate the color.

Operator

Thank you. Our next question comes from the line of Daniel Wolle with JPMorgan. Your line is now open.

Daniel Wolle — JP Morgan Securities — Analyst

Good morning, thank you for taking my question. Two questions first, regarding the Vertex agreement, considering recent attempts to use ADCs for conditioning by going after, for example, CD117. How differentiated are some of the targets you or Vertex are going after? And second question, understanding that – it’s only been a few months for ELAHERE, but given that it’s a drop shipment based ordering, what’s your visibility on the persistence of use?

Mark Enyedy — President and Chief Executive Officer

Right, so as it relates to Vertex, we’re not at liberty to comment on the targets, other than to say that these are being used in conjunction with their gene editing programs, and we’re very pleased to be partnering with a company the quality of Vertex. And then in terms of persistence, again, it’s early. I mean, what we can say is a significant and growing percentage of the orders are repeat orders or accounts who are repeat ordering. So, we’re obviously very encouraged by that. But again, we just don’t have a window into the what — how the duration of therapy at this point.

Daniel Wolle — JP Morgan Securities — Analyst

Great. Thank you.

Operator

Thank you. Our next question comes from the line of Jonathan Chang with SVB Securities. Your line is now open.

Jonathan Chang — SVB Leerink — Analyst

Hi guys, thanks for taking my questions. First question, can you provide more color around when this year we could get the ELAHERE product revenue guidance? What would need to happen first before you’re in a position to give guidance here? And then second, congrats on the Vertex partnership. Can you talk about how you’re thinking about different options for extending the cash runway? Thank you.

Mark Enyedy — President and Chief Executive Officer

Yeah, so I think, realistically, Jonathan, we’d like to have two solid quarters under our belt before providing guidance. So I could imagine, as we report out our second quarter earnings late in July or in early August that we would be in a position to give some guidance. And at that point, we would have some of the information that we’re — that many of you are reasonably asking at this point, what’s your duration of therapy, how do you think about the accounts, where is the business coming from. And I think we’ll have a much clearer idea on that and also the strength of the trends, a better evaluation. We have a going in position with respect to the value of individual targets in terms of anticipated patient starts, revenue etc. and titrating those data and are all really important.

And then sorry, Jonathan, the second question? Cash one, right Yes. So the first point to make is where we are with cash and cash equivalents and the application of the auditing test. We shared in this morning that — we will be sharing in our SEC filing, and that creates a going concern situation for the business. But that measure excludes — when you’re in a launch phase like we are, it excludes essentially all product revenue. They maybe give you credit for pennies on the dollar. So what we want to make sure that people understood clearly was that with the addition of our expected ELAHERE revenue that we’ve got significantly more than 12 months’ worth of cash for the business. That said, we are evaluating additional options to finance the business, which would include, for example, royalty financing with respect to the anticipated growth of the product, and there’s interest there. And then more classically follow-on offerings for the business and potentially even a modest amount of debt.

So those are things that we’re all evaluating. But I think, again, the most important point for everyone here is when we look at our business plan to include cash, cash equivalents, anticipated revenue from ELAHERE, and also, we’ve got this very broad portfolio of partnering agreements that include multiple folks with very active programs to include, for example,[Indecipherable] who expects to file with the Chinese FDA that we would get a milestone payment upon filing, and that’s coming in the second half of this year. So all that stuff gets excluded from the accounting analysis, but when we look at the full business plan, we’ve got more than 12 months of cash.

Jonathan Chang — SVB Leerink — Analyst

Got it. Thank you.

Operator

Thank you. Our next question comes from the line of Peter Lawson with Barclays. Your line is now open.

Peter Lawson — Barclays — Analyst

Great. Thanks for taking the question. Just the plans around the build out for the commercial infrastructure in the EU. And does your expense guidance include that EU [Speech Overlap]?

Mark Enyedy — President and Chief Executive Officer

It does, it does. I mean, obviously, in 2023, that’s going to be pretty limited. So we do have, ahead of our international business, we have a mighty one-room office in Zug as we speak, which is the start of what we’re doing. But the MAA filing would come later in the year, approval would come in 2024. And for many of you who have experienced following products being launched in Europe, the actual launch and commercial sales are sequenced according to reimbursement at a national level. So like many companies, we expect to start with Germany, but that would be very late in 2024. So we can approach this in a very judicious way. Obviously, we’ve had some very robust clinical development in Europe from all of our pivotal studies and will have for GLORIOSA and 420 as well.

So the experience base among ovarian cancer treaters in Europe is already pretty rich as it relates to ELAHERE use. So I think we start with a strong base — it’s a very concentrated market, Peter, so the last market research we did, just looking at the key five countries, more than 70% of patients are treated at just 65 centers. And of course, we’ve got a significant overlap with those centers in terms of where we’ve gone with our clinical trial. So again, we are approaching this in a judicious manner and the incremental commercial investment required to tap into a market with that level of concentration is very manageable.

Peter Lawson — Barclays — Analyst

Got you. And then just as regards to diagnostic testing, how is that going? Any wrinkles that developed? Or is it going smoother than expected, just any details around that.

Mark Enyedy — President and Chief Executive Officer

Yeah, so we had a chance to catch folks up a little bit earlier on the call, I think, before you joined, Peter. But the testing, frankly, has just exceeded our expectations. So we did 1,500 tests between the approval date and the end of the year. The volume of testing has increased. The ease of testing has not proven to be a barrier to entry. And I’ll just repeat what I said earlier, which was this is a physician base that is highly accustomed to testing. In fact, their receptivity to it exceeded our expectation, and that’s because they started out more than half a decade ago looking for BRCA mutations, moved on to homologous recombination deficiency testing. And so the layering in of folate receptor alpha has proven to be quite easy for these folks. They’ve integrated it. And what we’re seeing is a significant percentage of newly diagnosed patients being assessed for their FR alpha status, which we think is very encouraging.

Peter Lawson — Barclays — Analyst

Got you. Thank you. And I’m sure property been through before. But just around the change in the guidance in MIRASOL from early ’23 to 2Q. Any kind of technical reasons around that or was it kind of a longer-than-expected time frame to gain PFS events?

Anna Berkenblit — Senior Vice President, Chief Medical Officer

Yeah, so slightly longer period to get the PFS events we originally had guided to before the end of December in 2022, and now we’re imminent. So our models are as good as they can be. And clearly, our models weren’t perfect. And there’s other reasons you could speculate. Maybe the patients on mirvetuximab are doing a bit better. Maybe the patients on IC chemo are doing a little bit better. Maybe all of the patients are doing a little bit better and maybe there’s a combination of all of these factors. So don’t know, not worried. Imminently, we will trigger the final PFS analysis.

Peter Lawson — Barclays — Analyst

Great. Thanks so much.

Operator

Thank you. This concludes the Q&A session. I would now like to hand the conference back over to the team for closing remarks.

Mark Enyedy — President and Chief Executive Officer

Great. Well, thank you very much for joining us today. As you can hear from the comments here, there’s a lot of excitement for the business as we come into 2023 and look at the year ahead. The launch is exceeding our expectations, and we have a number of important readouts upcoming, so look forward to talking to you as we work through those data and report out subsequent earnings.

Operator

[Operator Closing Remarks]