Welcome to ImmunoGen's ELAHERE approval 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, and thank you for joining today's call. We recently issued a press release announcing the FDA's accelerated approval of mirvetuximab soravtansine-gynx or ELAHERE. 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, and Anna Berkenblit, our Chief Medical Officer. Theresa Wingrove, our SVP of Regulatory and Quality, and Susan Altschuller, our CFO, will also join us for Q&A. During today's call, we will be making forward-looking statements based on our current expectations and beliefs. These statements include those related to the potential full approval of ELAHERE, the continued development of the broader ELAHERE program, and the market opportunity for ELAHERE, and are subject to risks and uncertainties. Our actual results may differ materially. Please consult the risks and uncertainties outlined in our press release, in the Risk Factors section of our most recent annual report on Form 10-K, and in our quarterly reports on Form 10-Q, and in our other SEC filings, which are available at sec.gov and immunogen.com. The forward-looking statements in this presentation speak only as of the original date of this call, and we undertake no obligation to update or revise any of these statements. With that, I'll turn the call over to Mark. Good morning, and thank you for joining us today. We are thrilled to announce that FDA granted accelerated approval to ELAHERE. On behalf of everyone at ImmunoGen, I'd like to extend our gratitude to the patients, families, caregivers, investigators, and healthcare providers whose contribution to the clinical development of ELAHERE have made this moment possible. Starting with the label, ELAHERE is approved for the treatment of adult patients with FR alpha-positive platinum-resistant epithelial ovarian, fallopian tube, and primary peritoneal cancer who have received one to three prior systemic treatment regimens. Importantly, our indication statement does not require prior treatment with Avastin, which effectively doubles the eligible patient population relative to the SORAYA eligibility criteria. This approval marks a number of important firsts. In particular, ELAHERE is the first FRα-targeting ADC approved in ovarian cancer, the first new drug approved specifically for platinum-resistant disease since 2014, and our first independent product launch notwithstanding two other approved products, Kadcyla and Sarclisa, discovered with our platform. Suffice it to say there's more than a little energy around the building as we launch this important product and transition to a fully integrated oncology company as a leader in both the development and the commercialization of ADCs. Turning to the market, commercial readiness activities have been underway for the past year as we work to ensure the right strategy and team was in place to support a successful launch. Our commercial leadership team consists of top industry talent and brings deep expertise in sales, market access, strategy, and analytics. Our sales team of 44 dedicated folks is fully staffed, trained, and already engaging with customers in both the academic and community settings. This market is highly concentrated with roughly 4,300 physicians treating over 80% of ovarian cancer patients in the United States. At launch, we will be taking a targeted approach to bring ELAHERE effectively and efficiently to the U.S. market, focusing as an initial priority on 400 physicians who treat roughly 1/3 of patients. Our initial market opportunity is in the platinum-resistant setting, where there are 19,500 drug-treatable patients, of whom roughly 35%-40% express high levels of FRα and 75% currently receive either single-agent chemotherapy or non-bevacizumab regimens. This equates to an initial eligible population of roughly 5,200 patients. In addition, we have submitted to NCCN for compendia listing our approved indication as well as for the investigational use of ELAHERE plus Bev in the platinum-resistant setting. If included, the ELAHERE plus Bev would add an additional 1,800 FR alpha high patients to the market opportunity. Moving to the companion diagnostics, we're also pleased to announce that FDA contemporaneously approved Roche Tissue Diagnostics VENTANA FOLR1 (FOLR1-2.1) RxDx Assay to test patients for folate receptor alpha expression and identify those eligible for treatment with ELAHERE. There are multiple central labs ready to accept patient samples with ample capacity to cover expected volume. As the launch progresses, institutions will have the ability to bring testing in-house if they so choose. Importantly, to minimize access barriers, we plan to offer a sponsored testing program called FR-ASSIST at select labs that will cover 100% of the cost of the test for patients. While our educational efforts have increased awareness of folate receptor alpha, testing of tumor tissue, which can be archival or fresh biopsy, could not begin until now. Given this dynamic, there isn't an existing group of FR alpha-positive patients identified to initiate therapy on day one, so adoption will be driven in part by these patient identification efforts. We estimate that the average time to initiate ELAHERE will be two to three weeks from the time of ordering the FRα test to initial dosing, with a turnaround time for testing of three to five days and the remaining time taken in by scheduling patient visits. With respect to pricing, we have carefully considered the clinical benefit and significant unmet need addressed by ELAHERE. The wholesale acquisition cost of a 20 mg vial will be $6,220. We anticipate that government discounts, including Medicaid rebates and sales to 340B covered entities and VA facilities, will reduce the net price that we receive. Ensuring access for eligible patients is a key priority. We expect to be ready to ship ELAHERE in a matter of days. Given that we are using a drop ship model, we expect minimal inventory in the channel at launch and over time. In addition, our ELAHERE support services program is now live. This program, supported by our patient services team, will assist with activities such as benefits verification and our co-pay and patient assistant programs. Beyond the launch, we look forward to a number of additional milestones to come, including top-line results from our confirmatory randomized phase III MIRASOL trial early next year and the continued advancement of the overall mirv development program with the goal of expanding its use into platinum-sensitive disease. With that, I'll turn the call over to Anna to provide additional cover on the label and our ongoing development programs. Anna? Thanks, Mark. We are delighted to have received accelerated approval of ELAHERE in folate receptor alpha-positive platinum-resistant ovarian cancer, and that accelerated approval was granted ahead of the original PDUFA date. We believe this speaks to the significant need for better treatment options and the strength of the data supporting the ELAHERE application. Ovarian cancer is a devastating disease and the leading cause of death from gynecologic cancers. Most patients present with late-stage disease. After diagnosis, a patient will typically undergo surgery followed by platinum-based chemotherapy and more recently, maintenance therapy. Unfortunately, the majority of patients develop resistance. Treatment options for patients with platinum-resistant disease are limited, characterized by low overall response rates, short durations of response, and significant toxicities. Against this discouraging landscape, ELAHERE is a much-needed novel option. ELAHERE is indicated for the treatment of adult patients with folate receptor alpha-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. Eligible patients will be identified by Roche Tissue Diagnostics VENTANA FOLR1 Assay companion diagnostic. Recall the SORAYA study required pretreatment with bevacizumab. However, the FDA-approved label allows both bev-naïve and bev-pretreated patients. As described in the label, ELAHERE shows a confirmed overall response rate as assessed by investigator of 31.7%, including five complete responses among efficacy evaluable patients in this heavily pretreated population. Two of the 106 enrolled patients were excluded from the efficacy evaluable population in the label. One without measurable disease at baseline and one with platinum-sensitive disease. Duration of response was the key secondary endpoint with a median DOR of 6.9 months as assessed by investigator. In this challenging population, in addition to a 31.7% response rate, it's important to note that 46.2% of patients had stable disease as their best response. Turning to safety, the most common adverse reactions seen in SORAYA, including lab abnormalities, were vision impairment, fatigue, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, keratopathy, abdominal pain, decreased lymphocytes, peripheral neuropathy, diarrhea, decreased albumin, constipation, increased alkaline phosphatase, dry eyes, decreased magnesium, decreased leukocytes, decreased neutrophils, and decreased hemoglobin. The prescribing information includes a black box warning for ocular toxicities, including visual impairment, keratopathy, dry eyes, photophobia, eye pain, and uveitis. Ocular events observed with ELAHERE are predominantly low grade and most resolve without dose modifications. There were no permanent ocular sequelae observed in the study, and the discontinuation rate for ocular events was less than 1%. An ophthalmic exam, including visual acuity and slit lamp exam should be conducted at baseline and then every other cycle for the first eight cycles. These exams can be performed by eye care providers, including ophthalmologists and optometrists. The overall risk-benefit profile observed along with a convenient every three-week schedule of administration demonstrates the potential value of this new therapeutic option. In summary, we believe ELAHERE has the potential to displace single-agent chemotherapy as a new standard of care for patients with folate receptor alpha-positive platinum-resistant ovarian cancer. Turning to the rest of our development program for mirv, we are on track to report top-line data early next year from our confirmatory MIRASOL study, which is intended to support full approval in the U.S. and a marketing application in the EU. Of note, during the BLA review, FDA requested we submit preliminary ORR and DOR data from both arms of MIRASOL. To maintain data integrity for the ongoing MIRASOL trial, an independent third-party statistician performed the analyses and submitted the outputs directly to FDA. This approach is consistent with what was outlined by Dr. Pazdur in a recent New England Journal of Medicine publication regarding the accelerated approval pathway. We also advanced patient enrollment in PICCOLO, our single-arm study of mirv monotherapy in recurrent platinum-sensitive ovarian cancer patients with high folate receptor alpha expression, which may support label expansion in 2024. As we look to position MIRV as the combination agent of choice in ovarian cancer and expand its reach, we have initiated our phase III GLORIOSA study, which will evaluate the benefit of MIRV plus bevacizumab maintenance versus bev maintenance alone in the second-line platinum sensitive setting. We have also initiated Trial 420, a study of MIRV plus carboplatin, which is intended to inform a potential path to registration in recurrent platinum-sensitive ovarian cancer. Trial 420 is a single-arm phase II study of MIRV plus carboplatin followed by MIRV continuation in approximately 110 platinum-sensitive ovarian cancer patients with low, medium, or high expression of folate receptor alpha. At IGCS, we presented encouraging data for both the MIRV plus bev and the MIRV plus carbo doublets in folate receptor alpha-positive ovarian cancer. Notably, the MIRV bev combo demonstrates meaningful activity across a broad range of folate receptor alpha expression levels in patients who are bev-naive and pretreated and regardless of platinum-free interval. In summary, we believe we have the potential to expand the ELAHERE market opportunity in the U.S. beyond the 7,000 patients covered by initial label and potential compendia listings to over 11,000 patients if the studies I just laid out are successful. With that, I'll turn the call back over to Mark. Thanks, Anna. Just a couple of concluding remarks before we open the call for questions. First, I wanna express my great thanks to the ImmunoGen employees who've played a role in ELAHERE's development, approval, and launch preparations. The approval of ELAHERE is an important milestone as we seek to improve outcomes for ovarian cancer patients and offer them more good days. This is just the beginning of the next chapter for ImmunoGen. We believe we are well-positioned to continue delivering value for patients and driving growth for the company as we execute on our first independent product launch and continue to advance the broader mirvetuximab program, as well as our robust portfolio of novel next generation ADCs. With that, operator, we will open the call for questions. Thank you. As a reminder, to ask a question, please press star one one. Once again, if you would like to ask a question, please press star one one. Please stand by while we compile the Q&A roster. Our first question will come from John Newman from Canaccord Genuity. Your line is open. Hi, team. Huge congratulations here on the approval for ELAHERE. I know that many, many people at the company worked very hard and for a very long time for this achievement. Congratulations. Just had a few questions this morning. Thanks, John. Sure. Wondered first if you could talk a bit about the label if you're surprised that it's broader than the SORAYA study. Also, I noticed, it doesn't specifically mention requiring, high expression of folate receptor alpha, but I'm not sure how that's defined, so I wanted to ask about that. Third, just curious if you have any sense as to how soon, we might potentially see compendia listing for ELAHERE and, bevacizumab in combination. Thanks. Thanks, John. Regarding your question whether or not we were surprised by the label, you know, we have had productive conversations with FDA throughout the review process. Given the strength of the data from SORAYA and FDA's request during the review process, to see the ORR and DOR data from MIRASOL, which is a broader population of patients who are bev naive and bev pretreated, we are not surprised. Again, as we've gone through the process, you know, we've taken a conservative approach, as we have been communicating externally. We are delighted that we landed where we did with FDA. As we mentioned in the call, you know, this approach is consistent with Dr. Pazdur's guidance that he's provided in the recent New England Journal of Medicine article. Regarding your second question regarding folate receptor alpha, the companion diagnostic is designed so that patients with high FRα expression in their tumors are considered positive per the CDx, and that means at least 75% of the cells have at least 2+ intensity staining. There is some linguistic nuance there. The CDx refers to these patients as positive. We know that there are patients with lower levels of FRα expression who are not positive for the CDx, and we studied them extensively in our program and have shared those data. Regarding your third question, for when we should anticipate compendia listing, our understanding is that, you know, given we've already submitted to NCCN, they are really focused on getting NCCN compendia listing for approved indication within a couple of weeks to ensure that patients have access to novel therapies. For the combination, we anticipate that that will come soon thereafter. Okay. Excellent. Thank you. Thank you. One moment for our next question, please. Our next question will come from Michael Schmidt from Guggenheim. Your line is open. Hey, guys. Good morning and congratulations to the early approval from me as well. I just had a clarification on pricing, Mark. Can you just help us understand what your price per vial, you know, what does it translate to in terms of, you know, a price per treatment course per patient, if you could help us understand that? You know, as we think about the commercial launch, you know, with the testing dynamic, are there any good analogs that investors could consider when modeling the initial launch for the product in the U.S.? Lastly, on the testing, I was just wondering, you know, what percentage of patients do have archival tissue available, and would that, you know, offer a, you know, an initial, you know, access to patients that have that available rather than requiring fresh tissue for the test? Thanks so much. Yeah. Thanks, Michael. As we mentioned, the price per vial is $6,220. Most patients receive three to four vials per cycle, which results in a price of somewhere between $18,500 and just under $25,000 per cycle. In terms of testing analogs, it's an interesting question. As you think about ovarian cancer, this is a segment of oncology that's very accustomed to testing at this point. BRCA mutation testing has been prevalent since the middle of the last decade and the initial approval of the PARP inhibitors that's moved on to looking at homologous recombination deficiency. This class of test is an immunohistochemistry test, so similar to the approach taken to test for PD-L1. I mean, it's those variables that, you know, give us confidence in terms of the ability to, you know, have patients tested early in the launch. As we mentioned, there's no existing pool of FRα-positive patients outside of folks who may have been tested for our clinical trial. You know, we're starting with that as the base. That said, we've got four centralized labs that are up and running as we speak. We've got this FR-ASSIST program to remove cost as a barrier to access. You know, I don't think there's a particularly straightforward analog, but it's those considerations that give us confidence in terms of the uptake. Then lastly, your question around archival tissue. In our clinical studies, more than 95% of patients have had tissue available to be assessed for FR alpha eligibility. It's a very high number, and that's just a function of, you know, how these patients are managed from initial diagnosis. Almost all of them will undergo surgery, which produces tissue available for typing in this manner. Great. Thank you so much, and congrats again. Thanks. Thank you. One moment for our next question, please. Our next question will come from Etzer Darout from BMO Capital Markets. Your line is open. Great. Thanks for taking the question, and congratulations as well on this milestone. Wanted to just ask on sort of the data that the FDA saw ahead of sort of the approval. I recall, you know, you also had taken a blinded look at the curves for MIRASOL, and I just wanted to know kind of, you know, how was that also something that the FDA saw? Or Or was it specifically the response rate and the duration of response data that you cited in the press release? Thanks. Etzer, let me be clear. The data that FDA saw. Mm-hmm. Was ORR and DOR. Right. From MIRASOL. That is it. I think. Right. Perhaps you're thinking about the fact that we had an IDMC meeting early on in MIRASOL after 110 PFS events. The IDMC saw the PFS data for that futility analysis, but those data were not submitted to FDA. Got it. Thank you for the clarification. Thank you. One moment for our next question. Our next question will come from Boris Peaker from Cowen. Your line is open. Good morning. Let me add my congratulations to this approval. A lot of years working to get to this. I guess- Thanks. I have two questions. First, you mentioned a cost per cycle about $18,000-$25,000 per patient. I'm curious what your expectations of cycles per patient. Second is, how should we be thinking about SG&A costs in 2023, considering the launch? Sure. In terms of number of cycles, it really varies, Boris, by line of therapy and also whether or not we're combining with something else. You know, we've looked at duration of response. We've looked at progression-free survival and you know, I think most folks who are modeling and have tended to gravitate towards the DOR data in terms of the number of cycles. Boris, we haven't given 2023 guidance yet, but we have, you know, in our guidance that we've given for the cash runway that contemplates spend for the launch. Most of the upfront building costs were incurred in 2022, and now it's the kind of more the steady state run rate in 2023. Great. Thank you very much. That's very helpful. Thank you. One moment for our next question, please. Our next question will come from Andy Hsieh from William Blair. Your line is open. Thanks, and thanks for taking my question, and congratulations on the early approval, broad label too. Three questions from me, all kind of, you know, pretty quick. One has to do with eye exam support. Obviously, I think it makes a lot of sense to support patients for folate receptor testing. I'm just wondering if, you know, very similar program exists for eye exams given the fact that they are required to initiate therapy in every other cycle. Secondarily, I'm curious about, you know, market research regarding NCCN guideline listing. I'm just curious from a launch standpoint, do you view that as a major catalyst for doctors who are practicing to really embrace this new and exciting therapy? My final question has to do with in the label it mentioned that 6% of the patients had anti-drug antibodies that were neutralizing. I'm just curious about the potential clinical implications of that. Thank you. Great. Maybe I'll start at a high level in terms of the eye exam. You know, our team did a great job working with the FDA to get to where we landed in terms of a label with baseline exams and then exams every other cycle up to eight cycles. You know, in terms of the marketplace, one of the helpful things as we look at the launch is the fact that there's a drug Tivdak that is also used by gynecologic oncologists for cervical cancer. It has a more stringent set of requirements related to ocular exams where patients have to undergo an exam prior to every course as long as they're on therapy. The benefit there, however, is that these gyn-oncs have become accustomed to working with ophthalmologists. As our field force has been out profiling accounts in advance of launch, they have spoken with these physicians to understand what they have in place in terms of a referral network to support the baseline and any subsequent exam that might be needed on a go-forward basis. We look to leverage that to the extent that those referral networks don't exist, have gone out to understand what's available in the local market. It's important to understand that what's required here is an exam from an eye care professional. That could be either an ophthalmologist or an optometrist, you know, found in places like Walmart, for example. You know, we think that this is not a huge barrier and something that we are focused quite myopically on as we think about the launch. In terms of the NCCN guidelines and market research, we think about NCCN as the gold standard in terms of practice management, and many physicians look to the guidelines in terms of informing their treatment choices. Obviously, as to any individual patient, there's a myriad of factors that go into a treatment decision. Yes, the NCCN guidelines play an important role in terms of practice among individual physicians. Separately, the listing in the NCCN compendia will support reimbursement for discretionary use. We think it's an important element in terms of access, should a physician decide to use mirvetuximab, for example, in combination with bevacizumab that, or ELAHERE, I should say, in combination with the bevacizumab, that reimbursement is available to support that discretionary use. You know, in our market research, given the data that we've shared most recently at IGCS, you know, in terms of the response rate, durability of response with the ELAHERE bevacizumab combination, physicians are very excited about those data. Adding this to the compendia will be an important component as we go forward. Anna will take the ADA question. Yeah. As with all therapeutic proteins, there is always the potential for immunogenicity. This is a standard assessment that everyone does. You know, we were delighted that we have a low percent of patients with anti-drug antibodies. The short answer to your question, Andy, is the clinical implications are none. The slightly longer answer is that, you know, this contrasts with proteins that are known to be immunogenic. I'm just thinking of, for example, diphtheria toxin conjugates, where you have a high rate of anti-drug antibodies, and those can wind up clearing a drug very quickly, decreasing the half-life and potentially negatively impacting efficacy. Given our low rate of anti-drug antibodies, that's not an issue for us. Great. That's very helpful. Thank you so much, and congratulations again. Thanks, Andy. Thank you. One moment for our next question, please. Our next question will come from Peter Lawson from Barclays. Your line is open. Great. Thank you so much. Wonder if you could talk through the proportion of free drug you would expect on launch and then kind of your triangulation around pricing, as you're thinking about pricing on a monthly basis. Thank you. Yeah, Peter, we, you know, we've got a PAP program in place. You know, our patient support services program's there. We have co-pay assistance as well. I couldn't speculate today on what the percentage of PAP usage would be. You know, I think with the biologic, it will not be what, you know, some of the orals have experienced, but beyond that, I couldn't really comment. Just in terms of pricing overall, you know, I think we looked at two broad sets of consideration. First, around market dynamics, unmet need. I mean, you know, this is the first drug approved in this setting in eight years. You know, the existing therapies are characterized by low response rates, short duration of response, significant toxicity, and, you know, we overcome all of those challenges. You know, population size, and also, you know, other benchmarks in the marketplace, and particularly other ADCs. Looking at the product characteristics. As I said, you know, the basis for approval here is superiority over a meaningful improvement over available therapy. In our case, innovation. You know, again, this is the first ADC in ovarian cancer. It's the first approved therapy targeting, you know, a biomarker selected population. It's those considerations that went into our decision around the list price here. Perfect. Thank you. Just a follow-up question around MIRASOL. For PFS, what are you considering and what are physicians considering as being meaningful? Is it kind of a two-month benefit? Will we also get OS as well at the same time? Peter, MIRASOL is a randomized study comparing MIRVs versus investigator choice chemotherapy. The primary endpoint is progression-free survival. We've designed it to detect a hazard ratio of 0.7. That is conservative compared with what we already saw in FORWARD I for appropriately selected or identified FR alpha high patients, where we've already demonstrated a hazard ratio of 0.6. You know, in the FORWARD I study, the control arm in that population had a median PFS of 3.2 months and the FR alpha high patients on the mirvetuximab arm had a median PFS of 5.6 months. I think I would move you away from the idea of what is a meaningful difference in the point estimate of the medians, which just reflects that little bit of the population that's smack in the middle. I would encourage you to think about the totality of the benefit, looking at the shape of the PFS curves, the separation of the PFS curves, and particularly the tail of the curve that we see on the mirvetuximab when we look at any PFS curve. That really is a much better reflection of the benefit, and physicians know that. They are excited about MIRV because they see responses quickly. They see the majority of patients having tumor shrinkage over 70%, and even stable disease in patients with platinum-resistant disease is meaningful. I would encourage you to step back and think about progression-free survival, think about response, tumor shrinkage, overall clinical benefit. As you point out, we will have early overall survival data from MIRASOL. You know, we've already shown a strong trend favoring mirvetuximab over investigator choice chemotherapy in the FORWARD I study, and I would anticipate similarly in MIRASOL. Gotcha. Thank you. Will we get the complement curves next year, early next year? We look forward to presenting the full data from MIRASOL at a major medical meeting next year. Gotcha. Okay. Thank you so much. Thank you. One moment for our next question, please. Our next question will come from Kelly Shi from Jefferies. Your line is open. Congrats on a great success after tremendous journey. Follow the same question regarding what a physician's gonna use to assess the MIRV's treatment value. I'm curious, after the MIRASOL readout, would FDA label actually extended to include all the previous data, including FORWARD I, SORAYA and MIRASOL, and doctor's gonna take more like a holistic view on the ORR, DOR, PFS and OS endpoint? I also have follow-ups. We have designed MIRASOL to support full approval in the U.S.. Given that we already have a broad label, we do not anticipate that the label would be even broader. However, the label would then incorporate both efficacy and safety data from MIRASOL. I would point out that it already has safety data from the phase I study from FORWARD I and SORAYA in 464 ovarian cancer patients treated with mirvetuximab monotherapy. That safety data is there already, including from FORWARD I. MIRASOL will be incremental in terms of the safety data provided. Okay, thank you. Also another question from modeling perspective. What has been the median treatment duration and the discontinuation rate from previous clinical trials? Also, MIRV now indicated for the FRα OC patients with one-three prior systemic treatment regimens. From the previous trials, how patients are split into second line, third line, and fourth line, what are the majority of the patients actually coming from? Thank you. Yeah. In terms of the median treatment duration, I think the median DOR is probably a reasonable proxy of around seven months. In terms of the discontinuation rate, less than 1% of patients have discontinued for ocular adverse events, and the overall discontinuation rate is around or under 10%. Again, that is, you know, quite favorable when you think about the overall benefit of the patients. What about the patients who have slid into second line, third line, fourth line? Oh, right. Do you have that level of information? Yeah. Yeah, yeah, sure. What I can tell you is in FORWARD I, two-thirds of the patients had one to two priors and one-third had three priors. In SORAYA, about half of the patients had three prior lines of therapy and half had one to two priors. Off the top of my head, I can't recall the exact percent of patients with one prior, but that is a relative minority of patients, just because those are patients who have they responded to platinum, but then they recurred within, you know, three to six months after their initial platinum. The majority of patients are gonna be have had two and certainly three priors. Great. Thank you. Thank you. One moment for our next question, please. Our next question will come from Arthur He from H.C. Wainwright. Your line is open. Hey, good morning. Congrats on the approval and the broad label. I had one question regarding the gross to net margin. So Mark, could you give us more color on that part for the gross to net? Also, as you get the broader label without the Avastin use for the patient, how that impact your commercial strategy to getting more patient and as quick as possible? Thanks for that. The question around, you know, gross to net, I mean, you know, we're looking at what I think is a standard biologics margin here with the, you know, rebates and you know, contracting so on. We think 15% is a good number from a modeling perspective there. Sorry, can you restate the second question? My second question is because the label gets a broader capture of the patient population without a requirement for the prior treatment for the Avastin would that how would that impact your commercial strategy? You know, the answer is it's the same physicians, and what we've done here is expand the eligible population, basically twofold. Our prior experience with FORWARD I was about half the patients had prior bev and the other half did not. But in terms of the commercial strategy, again, very concentrated market. We've got, you know, 4,300 physicians that cover more than 80% of the market. 400 physicians cover a third of the market. We've designed the commercial strategy to initially target those higher volume prescribers, who tend to be located in academic centers, that they tend to be early adopters and thought leaders, and the community will follow. Removing the prior bev eligibility criteria really doesn't affect the commercial strategy here. I would just add, though, that it actually allows broader conversations. I think it's fair to say that there are some physicians who love Avastin and there are some physicians who don't. With the broad label, it doesn't matter because mirvetuximab is really appropriate per indication for patients regardless of prior Avastin use. It makes the conversations really generalizable regardless of physician practice patterns when it comes to Avastin. Thanks for that. Maybe regarding the follow-up label expansion, could you explain a little bit more color for us on what's your strategy for the label expansion beyond the current label? Thanks. Yeah. As we have been mentioning, we have several studies ongoing and initiated to expand the label. PICCOLO is enrolling. It's our single-arm, later line platinum-sensitive study of mirvetuximab monotherapy in FR alpha high patients, and that could potentially support label expansion in 2024. I think this population has increasing unmet need because there are more of these patients who've benefited from PARP maintenance in the upfront setting and still have platinum-sensitive disease, but they're not as platinum-sensitive as they would have been in the pre-PARP days. With the recent withdrawal of some indications of PARP inhibitors, I think there's gonna be an increasing unmet need there. Moving to GLORIOSA, which is our randomized phase III study that we've discussed with FDA and is initiated that is intended for mirvetuximab plus bevacizumab in the recurrent platinum sensitive maintenance setting. We're randomizing patients to mirv- bev versus bev alone. Progression-free survival is the primary endpoint, and this could really shift the treatment paradigm for patients. You know, we anticipate most will get PARP maintenance upfront, and then when they recur with recurrent platinum sensitive disease, our mirv-bev combination in recurrent platinum-sensitive disease could really move the needle on potentially improving overall survival based on the strength of the data we've already generated in the treatment setting. For MIRV plus carbo, we have a single-arm study exploring this combination of broader population of FRα-positive ovarian cancer that is buttressed by two investigator-sponsored trials that we are supporting, one in the neoadjuvant setting and one a randomized phase two in recurrent platinum-sensitive disease in Germany, led by Philipp Harter. Those three studies will help inform further development of MIRV plus carbo. Oh, thanks. Thanks for taking my question, and congrats again. Thank you. One moment for our next question, please. Our next question will come from Daniel Wolle from JP Morgan. Your line is open. Good morning, everyone. Thanks for taking my question, and congratulations on the approval. What's the payer mix for the approved patient group? In terms of reimbursement, can you give us some color on your current progress regarding negotiations with payers and the expected coverage initially and how it might evolve over time? How should we think about, you know, COGS for the product? Last but not least, can you comment on the inclusion of the NCCN guideline? All right. The first question was payer mix. We're about 55% Medicare, just under 40% commercial, and the remainder is Medicaid and some of the other federal programs. Sorry, the second question? It was about in terms of reimbursement. Oh. Yeah. Can you provide some color? Oh, the. On the current progress? Yeah. Market access team has been out, engaged with payers. This is not a particularly strictly managed market. You know, looking at, for example, the PARP inhibitors, you know, it's certainly covered to label. There's minimum step edits, prior authorization, that sort of thing. That's just a function of looking at this patient population. You know, if you take 5,200 eligible patients and spread it over multiple PBM plans, the budget impact is simply not very high. I think payers are focused elsewhere in terms of managing the market. Okay. The subsequent questions were, how should we think about COGS, and then can you comment on the inclusion of the NCCN guideline? Okay. Yeah. I mean, you know, we've got what I would consider, you know, standard biologics gross margins, as I mentioned, earlier. We wouldn't share what that is. We don't market NCCN, you know, guidelines. Those are available to physicians. The sales force is focused on the label for the product, which we're very pleased, you know, includes or does not include a requirement of prior bev. That team is very much focused on the four corners of the label, and that's how we'll approach the market at this point. Got it. Helpful. Thank you, and congratulations on the approval again. Thanks. Thank you. One moment for our next question. Our next question will come from Joseph Catanzaro from Piper Sandler. Your line is open. Great. Thanks for taking my question, guys, and let me add my congrats on a great outcome here. Two quick questions from me. I guess based on your discussions with FDA or maybe even from any FDA public comments, what's your understanding of what the FDA wants to see when they look at interim ORR and DOR data that you submitted? Do they wanna see statistical superiority or just numerical superiority? Any insight there would be really helpful. My second question, I think you said a couple times that DOR is a good reference point for modeling cycles of therapy. I think I saw somewhere in the label that median duration of treatment for SORAYA was 4.2 months. Just wondering why that wouldn't be a good reference point as well. Thanks. Yeah. Joe, when FDA asked in an information request to see interim ORR and DOR data, they did not really opine further in terms of why they wanted to see it. What I can say is just from a conceptual perspective, given how Richard Pazdur describes the accelerated approval pathway and recommendations to sponsors in terms of making sure that the confirmatory study is substantially completed at the time of regulatory action and FDA having the purview to ask for data from the ongoing confirmatory study, I think you can imagine FDA would want to see consistency of data across the studies to give them confidence that the surrogate endpoint used for accelerated approval, in our case ORR, with DOR as a key secondary endpoint, is clinically meaningful and holds up in a larger dataset. I could imagine that that's what they saw, and they saw that to the point that they were comfortable giving us the broad label, regardless of prior Avastin use, because those are the patients enrolled in MIRASOL. Regarding duration of treatment, the reason we don't think median duration of therapy is necessarily a good number to use when you're thinking about modeling is that there is a long tail on the curve. You know, the median is just where the patient in the middle, their duration of therapy. Half of the patients had a shorter duration, half of the patients had a longer duration. For that half who've had a longer duration of therapy, some of them have had a much longer therapy. Okay, got it. Very helpful. Thanks again for taking my questions. Thank you. One moment for our next question, please. We will take our last question from Jonathan Chang from SVB Securities. Your line is open. Hi, guys. It's Matt [Clark] on for Jonathan Chang. Thanks for taking my question, and congratulations on the approval. Just a couple from me. We noticed the rates of ocular toxicity appeared slightly higher in the label compared to some of the recent data. I was just wondering if you could provide any context on that. Second question is, do you still expect to reach the requisite PFS events for MIRASOL this quarter? Thanks. The ocular events seen in SORAYA, the rates were a little bit higher, particularly with the higher grade. What I would say is that the overall impact in terms of patients really is consistent between SORAYA and the entirety of the prior development program. What I mean by that is that the rates of dose modifications are similar and importantly less than 1% of patients discontinue due to ocular toxicity. You'll note that in the label, there is detail about one patient who had a grade 4 visual event that then resolved entirely within two weeks. I think that gives you a flavor of, you know, how grading translates into reality for patients. In terms of the PFS events for MIRASOL, we are on track to provide top-line data early next year. Great. Thanks for the color. Thank you. That does conclude our question-and-answer session for today's conference. I'd now like to turn the conference back over to the management team for any closing remarks. Great. Well, thank you all for joining us today. This is obviously a very exciting moment for the company, and we look forward to keeping you updated on our progress as we move through the end of the year and start 2023 with a strong launch. Thanks very much. Thank you. This concludes today's conference call. Thank you for your participation. You may now disconnect. Everyone, have a wonderful day.