Good morning, and welcome to ImmunoGen's fourth quarter and full year 2022 financial operating results conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Anabel Chan, Head of Investor Relations. Please go ahead. Good morning. Thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent operating progress in the 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. Thanks, Anabel Chan. Good morning, 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, pivekimab sunirine, advances in our early-stage programs, including reaching the recommended phase 2 dose for 936 and initiating phase 1 development with 151, rebuilding our pipeline through collaborations with Oxford BioTherapeutics and Biogen, and strengthening our management team with Michael Vasconcelles in the 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 pVec, and reporting top-line data from the expansion cohorts with 936. 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. Just a few qualitative updates on the ELAHERE launch. We are now just 3 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 first, 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 non-academic 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 FOLR1 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 FRα 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 were covered. 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 had 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. 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? Thanks, Mark. We are thrilled with ELAHERE's accelerated approval and excited by the early feedback we are receiving in the field from healthcare 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. We now expect to announce top-line data in the second quarter. Based on the totality of data generated with ELAHERE to date, we are excited about the prospect of this trial demonstrating improvement over investigator choice chemotherapy and supporting full approval of ELAHERE in the U.S. 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 FRα 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 2 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 FRα expression. Both trials are up and running in the U.S., with enrollment having begun in Trial 420. 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 PVEC 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 endpoint 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, 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 PVEC 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. 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 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 PVEC 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. We advanced our phase I study of IMGN151, our next-generation FRα-targeted ADC, by dosing our first patient in January and look forward to continuing patient enrollment this year. 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. 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 and $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. We intend to raise additional funds through equity, debt, or other financings. With that, we'll open the call for questions. Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please stand by while we come back to the Q&A roster. Our first question comes from the line of John Newman with Canaccord Genuity. Your line is now open. Hello, guys. Good morning. Thank you for taking my question. I just wanted 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 wondering what you're seeing here in terms of combination use, with Avastin at the moment. Thanks. Yeah. John, you're right that our primary PFS analysis, we're imminent in terms of triggering it based on the 330 requisite events. 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. While it's not the final OS analysis, we anticipate that the OS data will indeed be mature enough, you know, for regulators to understand the benefit of mirvetuximab. Of course, we will have the final OS analysis later when we hit the requisite number of events for that. I'll turn it over to Todd. 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. As we get additional patient data, we'll probably have a better idea of that in the next quarter or so. Okay, great. Thank you. Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open. Hey, 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, you know, we've talked about the 12% hurdle rate for chemotherapy. Is that similar in the platinum-sensitive setting for PICCOLO? Then, circling back to 936, I know you've talked about, you know, 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, you know, how many patients are in the expansion cohorts at this point. Thanks so much. Sure. In terms of the regulatory bar for recurrent platinum-sensitive ovarian cancer, and I would say later-line patients, so with 2 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-PARP days, if you will. While there are some studies out there that we can use, both in terms of platinum and non-platinum-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. 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. You know, we'll be able to talk about dose escalation, the recommended Phase 2 dose and schedule, and a little bit of color about how we got there. 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 'cause we like what we're seeing so far, and we might just wanna continue enrolling before we give a complete view of those data. Thank you. Thank you. Our next question comes from the line of Etzer Darout with BMO Capital Markets. Your line is now open. 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, you know, the ELAHERE sort of patient experience for those patients, given sort of mirvetuximab pre-bev. Again, I think that that kind of goes around sort of getting to the relative unknown, if you will, for MIRASOL 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. Yeah. Let me start, Etzer, and then I'll ask Todd if he wants to add any color. You know, as Todd alluded to, you know, 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. for example, while we do see, mir-bev use, for example, sort of trying to fix a percentage given the, you know, the early days of the data input, I think would, would not be productive. similarly, you know, looking at the question of whether a patient has received, prior bev, again, too early to tell. 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. You know, we are in very close, you know, contact with the accounts as new patient starts through, you know, ophthalmology referrals, and any and then any follow-up questions, you know, starting with as basic a thing as infusion to manage events as we go forward. You know, from a quantitative perspective, as I say, the data, you know, the claims data are just too early to give kind of definitive guidance in terms of breakdown of combo versus mono and, you know, where the line of treatment is and what the prior treatments were. Got it. Thank you. Our next question comes from the line of Boris Peaker with Cowen. Your line is now open. Great. thanks for taking my questions. I wanna focus on the screening for folate receptor alpha. You mentioned earlier that about 1,500 patients were screened, and that would've been, like, in the last month of the year. Can you comment how many patients have been screened since the time or maybe in 2023? Also, you've 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? Yeah. What I can say about testing is that the rate has increased. We basically did 1,500 tests in the first 6 weeks from approval through the end of the year, and that the testing rate has increased as we've moved through the first 2 months of 2023. We'll provide, you know, hard data when we have the next earnings call in terms of the actual quantity of tests. In terms of why does a physician want to assess FRα status in a newly diagnosed patient, what we see from this physician group is they've become very accustomed, you know, 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. The adoption rates, quite candidly, for newly diagnosed patients have exceeded our expectation. As it is because of the way in which this physician base has evolved in terms of their initial workup of the patients. The other thing it does is it It reduces any delay in terms of making a prescribing decision. Once they know that they've got an FRα-positive patient, you know, if that patient progresses to, you know, 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. Great. Thank you very much for taking my question. Thank you. Our next question comes from the line of Andy Hsieh with William Blair. Your line is now open. Great. Thanks for taking our questions. I have one about maybe potentially detecting an OS signal for MIRASOL. I remember the PS2+ re-analysis was pretty provocative from FORWARD I, and that was over a little bit over 100 patients versus 450 with MIRASOL. Just trying to understand, you know, the ability to detect that signal. Thank you, Andy. Your memory is absolutely correct. In FORWARD I, we had actually quite a strong trend, even in the 10X, if you will, FRα-high patients favoring mirvetuximab in overall survival. In the PS2+, so the properly identified FRα-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. All of these reasons make us confident that overall survival in MIRASOL will trend strongly in favor for mirvetuximab over chemotherapy. 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. We do not need that for regulatory approval either in the U.S. or Europe. No drug in ovarian cancer has been approved based on an overall survival benefit. 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. That's very helpful. 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? Yeah. 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. The PFS data from, say, the OCEAN study and the GOG-0213 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. Our study, you may remember, we randomized patients at the time of maintenance. Any patient, as long as they have not progressed, will be randomized to mir-bev versus bev maintenance. With that, you know, we've worked with our statisticians to do some modeling, and I think it's clear we have a very clear understanding of that has guided the sample size, and the hazard ratio, et cetera, that we've used to design the study. You know, I think we'll leave the details for that for another time. I think the important point is that for those patients who have not progressed, you know, Avastin maintenance has modest efficacy. I think with mirvetuximab plus Avastin, based on the strength of our doublet data, we anticipate a long progression-free survival. That's helpful. Thank you so much. Thank you. Our next question comes from the line of Kelly Shi with Jefferies. Your line is now open. Thank you for taking my questions. This is a follow-up regarding the OS data to be released at the MIRASOL update. I'm 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 OS benefit? Thank you. Kelly, I really can't answer your question because the point estimate for the median, you know, 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. What I would say is, you know, 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. Overall survival will certainly be part of the overall assessment that FDA does when they look at benefit risk. That's helpful. Thank you. Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is now open. Hi. Good morning, guys, and thanks for taking the questions. Quick one on the ELAHERE commercial rollout. Akash Tewari suggested that one of your diagnostic vendors, NeoGenomics Had some issues with processing, and this was causing some delays in test turnaround. As far as we understand it, these issues have recently been resolved. I just wanna confirm that this is indeed the case and that there's no testing bottlenecks now. Related to that, was the $30 million-$35 million guidance for ELAHERE sales for this year based on sales made during that period when you had this bottleneck, or is it purely take into account the more recent runway? I have a quick follow-up. No bottleneck in testing. You know, all 4 of the central labs are up and doing very robust business. The fourth lab is a small regional lab in Las Vegas. The 3, you know, key labs, which include LabCorp, NeoGenomics, as you mentioned, and Caris, are doing, you know, large volumes of testing, and there's no bottleneck. We've not given revenue guidance for ELAHERE, and we've deliberately done that, given, you know, the early days of the launch. Obviously, you know, many of you have provided your own estimates, and, you know, we look forward to reporting out data on a quarterly basis as we move forward. You know, what we're trying to do with you is give you know, a qualitative assessment of how the launch is proceeding based on what we think are the important metrics. You know, 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. You know, we continue to work nicely through the coverage decisions, and we started with a strong base, you know, at the beginning of this year, and Todd and his team have done, you know, 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. All of the things that we would hope for, as a, you know, as a new entrant in the market have materialized nicely. You know, our goal ultimately is to, you know, report out the, you know, the quantitative metrics to go along with these qualitatives in regular order in connection with the next earnings call. Okay, great. Just my quick follow-up is, up to 1,500 diagnostic tests that were of patients that were screened, maybe you can give any color on more recent numbers too, about what% of them were from patients who are currently on a first or second-line therapy for ovarian cancer? Just trying to see if there's a way for us to back out what the more immediate pent-up demand could be. Thanks. We don't exactly know at what stage 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. As Mark alluded to earlier, the testing has been shifting, and physicians are moving earlier and practices are moving earlier to, you know, earlier diagnosis. Really difficult for us to determine the actual place in therapy for where, when the testing actually occurred. Thanks, guys. Appreciate the color. Thank you. Our next question comes from the line of Danielle Brill with JP Morgan. Your line is now open. Good morning. Thank you for taking my question. 2 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? 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? Right. 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, you know, with, you know, a company of the quality of Vertex. In terms of, you know, persistence, again, it's early. I mean, what we can say is, you know, a significant and growing percentage of the orders are, you know, repeat orders or accounts who are repeat ordering. We're obviously very encouraged by that. Again, you know, we just don't have a window into what, you know, what, how the duration of therapy at this point. Great. Thank you. Thank you. Our next question comes from the line of Jonathan Chang with SVB Securities. Your line is now open. 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. I think, you know, realistically, Jonathan, we'd like to have, you know, two solid quarters under our belt before providing guidance. I could imagine, you know, 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. At that point, you know, we would have some of the information that we're, you know, that many of you are reasonably asking at this point, you know, what's your duration of therapy? How do you think about the accounts? Where is the, you know, where is the business coming from? I think we'll have a much clearer idea on that and also, you know, the strength of the trends, you know, a better evaluation. You know, we have a going in position with respect to, you know, the value of individual targets in terms of anticipated patient starts, revenue, et cetera. You know, titrating those data in are all really, really important. Sorry, John, second question? Cash one, right. Yeah. You know, the first point to make is, you know, where we are with cash and cash equivalents and the application of the auditing test, you know, we shared in this morning that it's, you know, We will be sharing in our SEC filing that, you know, that creates a going concern situation for the business. That measure excludes, when you're in a launch phase like we are, it excludes essentially all product revenue. They, you know, they maybe give you credit for pennies on the dollar. What we wanna make sure that people understood clearly was that, you know, 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. You know, more classically follow-on offerings for the business and potentially even a modest amount of debt. Those are things that we're all evaluating. I think, again, the most important point for everyone here is when we look at our business plan to include cash equivalents, anticipated revenue from ELAHERE, and also, you know, we've got this very broad portfolio of partnering agreements, that include, you know, multiple folks with very active programs to include, for example, HuaDong Medicine, who expects to file with the Chinese FDA, that, you know, we would get a milestone payment upon filing, and that's coming in the second half of this year. 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. Got it. Thank you. Thank you. Our next question comes from the line of Peter Lawson with Barclays. Your line is now open. Great. Thanks so much. Take the question. Just the plans around the build-out for the commercial infrastructure in the EU, does your expense guidance include that EU commercial infrastructure? It does. It does. I mean, obviously in, you know, 2023, that's gonna be pretty limited. We do have a head of our international business. We have a mighty one-room office in Zug, as we speak, which is, you know, the, you know, the start of what we're doing. You know, the MAA filing would come later in the year, approval would come in 2024. You know, for many of you who have experience following products being launched in Europe, the actual launch and commercial sales are sequenced according to reimbursement at a national level. You know, like many companies, we expect to start with Germany, but that would be very late in 2024. We can approach this in a very judicious way. Obviously, we've had some very robust clinical development in Europe from, you know, all of our pivotal studies, and will have for GLORIOSA and Trial 420 as well. The experience base among ovarian cancer treaters in Europe is already pretty rich as it relates to ELAHERE use. I think we start with a strong base. It's a very concentrated market, Peter. You know, the last market research we did just looking at the key five countries, more than 70% of patients are treated at just 65 centers. Of course, we've got significant overlap with those centers in terms of where we've gone with our clinical trials. Again, we are approaching this in a judicious manner and the incremental commercial investment required to tap into a you know, a market with that level of concentration is very manageable. Gotcha. Thank you. Just as regards to diagnostic testing, how's that going? Any wrinkles that have developed or is it going smoother than expected? Just any details around that because. Yeah. Yeah. We had a chance to catch folks up a little bit earlier, on the call, I think, before you joined, Peter. You know, the testing, frankly, has just exceeded our expectations. You know, 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. 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, you know, they started out more than a half a decade ago looking for BRCA mutations. Moved on to homologous recombination deficiency testing. The layering in of folate receptor alpha has proven to be, you know, quite easy for these folks. They've integrated it, and what we're seeing is, you know, a significant percentage of newly diagnosed patients being assessed for their FR alpha status, which we think is very encouraging. Gotcha. Thank you. I'm sure you've probably 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 timeframe to gain PFS events? Yeah. 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. You know, our models are as good as they can be, and clearly, our models weren't perfect. You know, 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. Don't know, not worried. Imminent, imminently will trigger the final PFS analysis. Great. Thank you so much. Thank you. This concludes the Q&A session. I would now like to hand the conference back over to the team for closing remarks. 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. Look forward to talking to you as we work through those data and report out subsequent earnings. Thanks very much. This concludes today's conference call. Thank you for participating. You may now disconnect.