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ImmunoGen, Inc. (IMGN) Q4 2022 Earnings Call Transcript

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ImmunoGen, Inc. (NASDAQ:IMGN) Q4 2022 Earnings Conference Call March 1, 2023 8:00 AM ET

Company Participants

Anabel Chan - Head, IR

Mark Enyedy - President and CEO

Anna Berkenblit - Chief Medical Officer

Renee Lentini - Interim-CFO

Todd Talarico - Interim-Chief Commercial Officer

Conference Call Participants

John Newman - Canaccord Genuity

Michael Schmidt - Guggenheim

Etzer Darout - BMO Capital Markets

Boris Peaker - Cowen

Andy Hsieh - William Blair

Kelly Shi - Jefferies

Asthika Goonewardene - Truist

Daniel Wolle - JPMorgan

Jonathan Chang - SVB Securities

Peter Lawson - Barclays

Operator

Good morning, and invited to ImmunoGen's Fourth Quarter and Full Year 2022 Financial and Operating Results Conference Call. Today's convention is being recorded.

At this time, I'd for illustration to move nan telephone complete to Anabel Chan, Head of Investor Relations. Please spell ahead.

Anabel Chan

Good morning, and convey you for joining today's call. Earlier today, we issued a property merchandise that includes a summary of our caller operating advancement and 4th fourth and afloat twelvemonth 2022 financial results. This property release, a signaling of this telephone and an updated firm platform tin beryllium recovered nether nan Investors and Media conception of our website astatine immunogen.com.

With maine coming 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 subordinate america for Q&A.

During today's call, we will reappraisal caller accomplishments for nan business, our financial results and item upcoming anticipated events. We will beryllium making forward-looking statements based connected our existent expectations and beliefs. These statements are taxable to risks and uncertainties, and our existent results whitethorn disagree materially. Please consult nan risks outlined successful our property merchandise issued this greeting successful nan Risk Factors conception of our astir caller yearly study connected Form 10-K and successful our different SEC filings, which are disposable astatine sec.gov and immunogen.com.

With that, I'll move nan telephone complete to Mark.

Mark Enyedy

Thanks, Anabel. Good greeting and convey you for joining america today.

2022 was a landmark twelvemonth for ImmunoGen pinch important advancement connected aggregate fronts highlighted by nan support and motorboat of ELAHERE arsenic nan first and only ADC for nan curen of platinum-resistant ovarian crab encouraging information from our 2nd pivotal program, PVAC advances successful our early shape programs, including reaching nan recommended Phase 2 dose for 936 and initiating Phase 1 improvement pinch 151, rebuilding our rebuilding our pipeline done collaborations pinch Oxford BioTherapeutics and [Biocean], and strengthening our guidance squad pinch Michael Vasconcelles successful a recently created domiciled arsenic Executive Vice President, Research, Development and Medical Affairs; and Daniel Char, arsenic General Counsel.

In addition, this morning, we were pleased to denote a world multi-target licence and action statement pinch Vertex. We are excited to partner pinch a leader successful transformative medicines and judge this woody nicely reflects our continued invention successful nan ADC abstraction and demonstrates nan worth of our exertion level and related intelligence property.

With nan momentum generated complete nan past 12 months, we look guardant to a number of important milestones successful 2023 that will see building connected nan beardown commencement to nan ELAHERE launch, astir which I'll person much to opportunity successful a moment, reporting information from our confirmatory MIRASOL proceedings and submitting regulatory filings to support afloat support of ELAHERE successful nan EU and U.S., sharing ORR information from PICCOLO successful platinum-sensitive disease, completing enrollment successful our pivotal BPDCN study and updating information from expanded frontline cohorts successful AML pinch PVC and reporting apical statement information from nan description cohorts pinch 936.

So we're proud of what we accomplished complete nan past 12 months and look guardant to an breathtaking and productive twelvemonth up arsenic we turn our business, thrust worth for shareholders and present much bully days for patients.

So conscionable a fewer qualitative updates connected nan ELAHERE launch. We are now conscionable 3 months successful and seeing beardown capacity crossed each of nan cardinal imperatives we group for nan business. First, uptake has been wide and deep. As a reminder, our first diligent was treated connected December 1, and we generated $2.6 cardinal successful nett income for nan quarter, astir each of which came successful December. Through nan extremity of 2022, astir 70% of our orders came from nonacademic settings and 75% of our orders from accounts pinch nary anterior ELAHERE experience, which is simply a beardown parameter of nan breadth and extent of adoption. In nan caller year, gross maturation has accelerated arsenic we are seeing a important percent of accounts, pinch repetition orders complementing caller diligent starts.

Turning to testing. Strong request continues for nan afloat R1 diagnostic done nan 4 cardinal labs group up successful collaboration pinch our CDx partner, Roche. In addition, we're besides seeing caller labs petition certification to tally nan trial in-house, which we judge is different favorable motion of expert and diligent interest.

Through nan extremity of 2022, we estimate that astir 1,500 tests person been performed, and that measurement has accrued arsenic we person moved into nan first quarter. Consistent pinch our acquisition efforts, we judge a important percent of these tests are being ordered for recently diagnosed patients. While these patients are not eligible for curen pinch ELAHERE today, this will alteration oncologists to quickly incorporated ELAHERE into their early curen decisions.

In addition, our search indicates that FR alpha positivity rates stay accordant pinch our objective proceedings acquisition of betwixt 35% and 40%. Regarding coverage, we're again disconnected to a accelerated commencement successful position of entree pinch a increasing number of nationalist and location payers, including ELAHERE connected sum policies aligned to our label. Recall that arsenic of early January, 18% of Medicare and 25% of commercialized lives recovered, driven by nan efforts of our entree team, sum has quickly accrued this quarter. We were besides pleased to spot ELAHERE was added to nan NCCN guidelines successful December arsenic some monotherapy and successful operation pinch bevacizumab.

Finally, our customer-facing teams are highly progressive successful position of reach. As of nan extremity of December, our commercialized and aesculapian teams person connected pinch 70% of their privilege targets, pinch these numbers continuing to summation successful nan caller year. Finally, our teams study that feedback from aesculapian experts and clinicians for ELAHERE has been enthusiastic, and we are leveraging these customer insights to guarantee affirmative expert and diligent experiences arsenic we move forward.

So arsenic you tin see, we've made beardown advancement successful nan early months of motorboat and are excited astir this momentum done nan remainder of nan twelvemonth and look guardant to reporting nan quantitative metrics for nan first 4th during our adjacent net call.

With that, I'll move nan telephone complete to Anna to supply further colour connected our ongoing improvement programs. Anna?

Anna Berkenblit

Thanks, Mark.

We are thrilled pinch ELAHERE's accelerated support and excited by nan early feedback we are receiving successful nan section from wellness attraction providers. We're pleased that information from nan SORAYA study, which supported ELAHERE's accelerated support were published successful nan Journal of Clinical Oncology successful January.

In February, nan information and efficacy information of MIRV successful operation pinch bevacizumab successful platinum-resistant ovarian cancer, which supported its inclusion successful NCCN guidelines, were published successful Gynecologic Oncology. We look guardant to an progressive twelvemonth ahead, including nan position of further efficacy information from SORAYA by series of curen arsenic good arsenic nan last wide endurance study astatine SGO later this period successful Tampa.

While it has taken a small spot longer than anticipated to scope nan requisite number of PFS events, we will imminently scope nan 330 PFS events needed to trigger nan superior study successful nan confirmatory MIRASOL trial, and we now expect to denote apical statement information successful nan 2nd quarter.

Based connected nan totality of information generated pinch ELAHERE today, we are excited astir nan imaginable of this trial, demonstrating betterment complete investigators' prime chemotherapy and supporting afloat support of ELAHERE successful nan U.S. and submission of an MAA successful Europe.

Let maine now move to nan broader MIRV improvement program, which has nan imaginable to meaningfully grow nan ELAHERE label. In January, we completed enrollment successful Piccolo, our single-arm study of MIRV monotherapy successful recurrent platinum-sensitive ovarian crab patients pinch precocious FR alpha expression. We expect information connected nan superior endpoint of ORR earlier nan extremity of this year.

As we look to position MIRV arsenic nan operation supplier of prime successful ovarian cancer, we are progressing 2 studies. The first is our Phase 3 GLORIOSA study evaluating MIRV positive bevacizumab attraction versus modular of attraction bevacizumab attraction successful nan second-line platinum-sensitive setting. With nan robust information we've generated for this operation successful nan platinum-resistant mounting supporting NCCN compendia listing, we are excited to move this operation up into nan platinum-sensitive mounting wherever patients person nan imaginable to use from moreover longer curen duration.

The 2nd is proceedings 420, a single-arm Phase 2 study evaluating mirvetuximab positive carboplatin, followed by mirvetuximab continuation successful platinum-sensitive ovarian crab patients pinch low, mean and precocious levels of FR alpha expression. Both tests are up and moving successful nan U.S., pinch enrollment having begun successful Study 420, and we are actively moving connected opening some studies successful Europe.

In parallel pinch nan important advances we person made connected nan MIRV program, we are besides pleased pinch nan caller advancement of PVAC successful some BPDCN and AML. As you whitethorn recall, we antecedently aligned pinch FDA connected a pivotal frontline cohort of up to 20 patients successful our Phase 2 CADENZA study arsenic a way to afloat approval, pinch CR/CRc arsenic nan superior extremity constituent and long of CR/CRc arsenic a cardinal secondary endpoint.

In an first study of information from this study, we were encouraged pinch nan activity seen successful some de novo and PCHM patients, aliases patients pinch a anterior aliases concomitant hematologic malignancy, pinch 11 of 13 aliases astir 85% of patients achieving immoderate shape of complete response.

In chat pinch FDA, we aligned pinch nan superior efficacy evaluable organization will beryllium successful de novo BPDCN patients. Enrollment successful CADENZA has accrued pursuing nan merchandise of these first data, and we expect to complete enrollment earlier nan extremity of this twelvemonth and study apical statement information from nan de novo cohort successful 2024.

In AML, we presented, arsenic portion of our 4th consecutive oral position astatine ASH, promising efficacy information findings from dose escalation and description cohorts of nan 802 study. This Phase 1b/2 study is evaluating PVAC pinch venetoclax and azacitidine successful patients pinch relapsed/refractory and frontline AML. This caller triplet showed manageable information floor plan and beardown anti-leukemia activity, pinch an nonsubjective consequence complaint of 45% and composite complete remission aliases CCR complaint of 25% successful our expanded relapsed/refractory cohort.

We observed compelling CCR rates crossed various relapsed/refractory diligent subgroups. And importantly, successful our first frontline cohort, 50% of patients achieved a CR. Based upon nan encouraging results from these first 10 frontline patients enrolled, we person moved guardant quickly pinch gathering much information for nan triplet utilizing 14 days of venetoclax and precocious completed enrollment of this cohort.

Separately, we are seeing beardown recruitment successful a 2nd cohort of up to 50 frontline patients pinch nan extremity of evaluating up to 28 days of nan venetoclax per rhythm to optimize nan long of therapy. Tolerability and efficacy outcomes from these cohorts will guideline pivotal improvement of nan triplet successful frontline AML.

In addition, our precocious announced objective collaboration pinch Gilead will measure nan information and anti-leukemia activity of PVAC successful operation pinch magrolimab and will comprise a caller cohort of up to 42 patients pinch relapsed/refractory CD123-positive AML successful nan 802 study. We scheme to initiate, this caller cohort successful our ongoing 802 study later this year, pinch complete consequence complaint arsenic nan superior endpoint.

Turning now to nan remainder of nan pipeline, we've completed dose escalation pinch IMGC936 and are focused connected expanding to non-small compartment lung crab arsenic good arsenic triple-negative bosom cancer. We look guardant to sharing information from nan Phase 1 dose escalation and our first acquisition connected these description cohorts successful Q2 of this year.

In addition, we precocious our Phase 1 study of IMGN151, our adjacent procreation FR alpha targeted ADC by dosing our first patients successful January and look guardant to continuing diligent enrollment this year. So, awesome advancement successful 2022 and we're looking guardant to an eventful 2023.

With that, I'll move nan telephone complete to Renee to screen nan financials.

Renee Lentini

Thanks, Anna.

For nan afloat twelvemonth 2022, we generated $108.8 cardinal successful revenue, including $76 cardinal of licence and milestone fees $2.6 cardinal successful nett merchandise income of ELAHERE and nan remainder from non-cash royalty revenues.

Operating expenses were $329.5 cardinal comprised of $213.4 cardinal of R&D expenses, compared pinch $151.1 cardinal successful 2021 and $116.1 cardinal of SG&A expenses compared pinch $43.8 cardinal successful nan anterior year. We ended 2022 pinch $275.1 cardinal successful rate connected nan equilibrium sheet.

Turning to our financial guidance for 2023, we expect revenues excluding merchandise gross from ELAHERE to beryllium betwixt $30 cardinal to $35 cardinal and operating expenses betwixt $310 cardinal and $320 million. We expect to supply ELAHERE merchandise gross guidance later this year.

Excluding anticipated ELAHERE and collaboration revenue, our level of rate and rate equivalents arsenic of December 31, 2022 unsocial is not capable to meet our existent operating scheme done March 1, 2024.

With nan summation of forecasted ELAHERE merchandise gross and milestone payments nether existing collaboration agreements, we expect these amounts mixed pinch existing rate will money operations for much than 12 months, from nan day of this merchandise and we intend to raise further costs done equity, indebtedness aliases different financings.

With that, we'll unfastened nan telephone for questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first mobility comes from nan statement of John Newman pinch Canaccord Genuity. Your statement is now open.

John Newman

Hello, guys. Good morning. Thank you for taking my question. I conscionable want to corroborate connected nan apical statement information readout from MIRASOL that, will of people see nan mature PFS information arsenic expected. And immoderate accusation connected wide survival, which I judge you antecedently said would beryllium immature, but you'd travel long-term. Also funny connected nan ELAHERE launch, conscionable wondered what you're seeing present successful position of operation usage pinch Avastin astatine nan moment? Thanks.

Anna Berkenblit

Yes, truthful John, you're correct that our superior PFS study were imminent successful position of triggering it based connected nan 330 requisite events. And erstwhile we person top-line data, we will stock PFS data. We will besides stock first OS data. In position of nan level of maturity of OS data, we expect that location will beryllium astir apt astir greater than 60% of nan wide endurance events.

So while it's not nan last OS analysis, we expect that nan OS information will so beryllium mature capable for regulators to understand nan use of mirvetuximab and past of people we will person nan last OS study later erstwhile we deed nan requisite number of events for that. Now I'll move it complete to Todd.

Todd Talarico

Yes, convey you. John, astatine this clip from an Avastin combination, attack wherever you don't person nan information yet to really measure nan utilization of ELAHERE arsenic a monotherapy aliases successful combination, but arsenic we get further diligent data, we'll astir apt person a amended thought of that successful nan adjacent 4th aliases so.

John Newman

Great, convey you.

Operator

Thank you. Our adjacent mobility comes from nan statement of Michael Schmidt pinch Guggenheim. Your statement is now open.

Michael Schmidt

Hi, guys. Thanks for taking my questions. I had 1 regarding nan upcoming PICCOLO information later this year. Just wondering really we should deliberation astir nan regulatory barroom successful position of consequence rate. I deliberation successful nan platinum-resistant setting, we've talked astir nan 12% hurdle complaint for chemotherapy. Is that akin successful nan platinum-sensitive mounting for PICOLLO? And past circling backmost to 936, I cognize you've talked astir presenting information successful nan 2nd 4th from dose escalation, early description cohorts. Just wondering if you could springiness america immoderate much colour connected nan benignant of nan amount of nan data, really galore patients are successful nan description people astatine this point. Thanks truthful much.

Anna Berkenblit

Sure. So successful position of nan regulatory barroom for recurrent platinum-sensitive ovarian cancer, and I would say, later statement patients, truthful pinch 2 aliases much priors, location is nary clear bar, dissimilar successful nan platinum-resistant mounting wherever we aligned pinch FDA arsenic you pointed out, connected 12% based connected aggregate Phase 3 tests pinch interrogator prime chemotherapy.

In nan later statement recurrent platinum-sensitive setting, this is an evolving, emerging and increasing unmet request pinch much patients falling into this class aft having had a anterior PARP inhibitor arsenic maintenance. Recent information person shown so that PARP inhibitors whitethorn consequence successful transverse resistance, truthful that moreover if patients technically person platinum-sensitive disease, they whitethorn not beryllium arsenic delicate arsenic they were previously, successful nan pre-park days, if you will.

And truthful while location are immoderate studies retired location that we tin use, some successful position of platinum and nonplatinum-based combinations, peculiarly successful patients pinch BRCA mutations, which are only astir 20%, 25% of patients, we person a consciousness of what nan efficacy is, but we would really request to prosecute pinch FDA connected what nan barroom would be. And each I tin opportunity is nan greater nan activity of mirvetuximab successful nan PICCOLO study, nan easier that speech will be.

Moving to your 2nd mobility connected 936, we do expect sharing information successful Q2 connected nan findings from dose escalation. So we'll beryllium capable to talk astir dose escalation, nan recommended Phase 2 dosing schedule and a small spot of colour astir really we sewage there. And past we'll beryllium capable to supply first information connected description cohorts successful triple-negative bosom crab and non-small compartment lung cancer.

I deliberation we'll beryllium capable to stock capable information connected triple-negative bosom cancer. We whitethorn clasp disconnected connected sharing information from lung crab -- from non-small compartment lung crab because we for illustration what we're seeing truthful far, and we mightiness conscionable want to proceed enrolling earlier we springiness a complete position of those data.

Michael Schmidt

Thank you.

Operator

Thank you. Our adjacent mobility comes from nan statement of Etzer Darout pinch BMO Capital Markets. Your statement is now open.

Etzer Darout

Great. Thanks for taking nan question. One for me, possibly a small spot excessively immature fixed your earlier commentary. But I conscionable wondered if you had a consciousness benignant of nan percent of patients that are being fixed ELAHERE pre-bevacizumab. And immoderate colour connected nan ELAHERE benignant of diligent acquisition for those patients fixed benignant of mirvetuximab, pre-bev and again, I deliberation that benignant of goes astir benignant of getting to nan comparative unknown, if you will, from MARISOL outcome. And if you could benignant of summation immoderate incremental insights into that based connected patients fixed that nan supplier benignant of pre-bev versus station bev.

Mark Enyedy

Let maine commencement reply and past I'll inquire Todd if he wants to adhd immoderate color. So arsenic Todd alluded to, our champion disposable information will travel from evaluating claims data. It's very early successful position of nan procreation of those information from nan outer sources. And truthful for example, while we do spot mirv-bev use, for example, benignant of trying to hole nan percent fixed nan early days of nan information inputs, I think, would not beryllium productive.

Similarly, looking astatine nan mobility of whether a diligent has received anterior bev, again, excessively early to tell. But what I would opportunity is nan feedback that we're getting from nan section anecdotally continues to beryllium highly enthusiastic successful position of nan usage of nan supplier and managing patients connected an ongoing basis.

As I mentioned, we spot an expanding percent of repetition orders to complement nan caller diligent starts, which is encouraging. And we are successful very adjacent interaction pinch nan accounts arsenic caller diligent starts done ophthalmology referrals and past immoderate follow-up questions, starting pinch this basal point is infusion to negociate events arsenic we spell forward.

So from a quantitative perspective, arsenic I say, nan information -- nan claims information are conscionable excessively early to springiness benignant of definitive guidance successful position of breakdown of combo versus mono and wherever nan statement of curen is and what nan anterior treatments were.

Etzer Darout

Got it.

Operator

Thank you. Our adjacent mobility comes from nan statement of Boris Peaker pinch Cowen. Your statement is now open.

Boris Peaker

Great. Thanks for taking my questions. I want to attraction connected nan screening folate receptor alpha. You mentioned earlier that astir 1,500 patients were screened that would person been for illustration successful nan past period of nan year. Can you remark really galore patients person been screened since nan clip aliases possibly successful '23? And also, you mentioned that galore of nan tests are being done successful recently diagnosed patients. Can you mention why are docs doing this if they really don't person a therapeutic action based connected this trial for recently diagnosed patients?

Mark Enyedy

Yes. So what I tin opportunity astir testing is that nan complaint has accrued since nan -- truthful we fundamentally did 1,500 tests successful nan first six weeks from support done nan extremity of nan year, and that nan testing complaint has accrued arsenic we moved done nan first 2 months of 2023. And we'll supply difficult information erstwhile we person nan adjacent net telephone successful position of nan existent amount of test.

In position of why does nan expert want to measure FR alpha position successful a recently diagnosed patient, what we spot from this expert group is they've go very accustomed complete nan past respective years, initially looking for BRCA mutations and much precocious for homologous recombination deficiency to really understand nan familial floor plan wholly of nan tumor.

And truthful nan take rates, rather candidly, and for recently diagnosed patients person exceeded our expectation. And it is because of nan measurement successful which this expert guidelines has evolved successful position of their first activity of nan patients.

And truthful -- and nan different point it does is, it reduces immoderate hold successful position of making a prescribing decision. So erstwhile they cognize that they've sewage an FR alpha affirmative patient, if that diligent progresses to -- wrong our label, there's nary request for a consequent test. They tin usage nan antecedently disposable information and beforehand nan diligent connected to ELAHERE immediately.

Boris Peaker

Great, convey you very overmuch for taking my questions.

Operator

Thank you. Our adjacent mobility comes from nan statement of Andy Hsieh pinch William Blair. Your statement is now open.

Andy Hsieh

Great, acknowledgment for taking our questions. I person 1 astir possibly perchance detecting connected OS awesome for MIRASOL. I retrieve nan PS2 positive nan study was beautiful provocative from FORWARD I, and that was complete a small spot - it was a small spot complete 100 patients versus 450 pinch MIRASOL, truthful conscionable trying to understand nan expertise to observe that signal?

Anna Berkenblit

Yes, convey you, Andy. So your representation is perfectly correct. In FORWARD I, we had really rather a beardown inclination moreover successful nan 10x, if you will, for alpha precocious patients favoring mirvetuximab successful wide survival. And successful nan PS2 plus, truthful nan decently identified FR alpha-high patients, location was a very bully awesome for OS favoring mirvetuximab complete interrogator prime chemotherapy. You're right, successful a comparatively mini subset, and it was post-hoc.

And so, each of these reasons make america assured that wide endurance successful MIRASOL will inclination powerfully successful favour for mirvetuximab complete chemotherapy, and my anterior constituent that we'll person greater than 60% of nan events. So nan OS information will beryllium comparatively mature and interpretable astatine nan clip of nan superior PFS study is important. You're right, we enrolled a small complete 450 patients.

So nan study does person reasonable powerfulness to observe a statistically important betterment successful wide survival, but we do not request that for regulatory approval, either successful nan U.S. aliases Europe. No supplier successful ovarian crab has been approved based connected an wide endurance benefit. So arsenic agelong arsenic we spot a affirmative inclination successful nan correct direction, we'll beryllium fine.

And location is simply a chance we could deed statistical significance. Again, nan stronger nan OS data, nan easier nan conversations are successful Europe, peculiarly astir payers and entree and nan worth proposition.

Andy Hsieh

That's very helpful. And possibly from a modeling perspective, looking astatine nan GLORIOSA study, I'm conscionable curious, really should we deliberation astir nan capacity successful position of PFS for nan Avastin power arm?

Anna Berkenblit

Yes, truthful that's a bully question, Andy, and it's not 1 that tin beryllium easy answered based connected nan information from published studies looking astatine nan triplet successful and of itself, because nan PFS information from, say, nan OCEAN study and nan GOG 213 study is counted from nan day of randomization for nan triplet and past continues on, including nan triplet long and past arsenic good arsenic nan Avastin attraction component.

So our study, you whitethorn remember, we randomized patients astatine nan clip of maintenance. So immoderate patient, arsenic agelong arsenic they person not progressed, will beryllium randomized to MIRV BEV versus BEV maintenance. And truthful pinch that, we've worked pinch our statisticians to do immoderate modeling. And I deliberation it's clear we person a very clear knowing of that. That has guided nan sample size and nan hazard ratio, et cetera, that we person utilized to creation nan study.

I deliberation we'll time off nan specifications for that for different time. But I deliberation nan important constituent is that for those patients who person not progressed, Avastin attraction has humble efficacy. And I deliberation pinch mirvetuximab positive Avastin, based connected nan spot of our doublet data, we expect a agelong progression-free survival.

Andy Hsieh

Thanks, that's helpful. Thank you truthful much.

Operator

Thank you. Our adjacent mobility comes from nan statement of Kelly Shi pinch Jefferies. Your statement is now open.

Kelly Shi

Thank you for taking my questions. This is simply a follow-up regarding nan OS information to beryllium released astatine nan MIRASOL update. Just curious, you conscionable mentioned nan OS use will not beryllium nan ground for nan afloat support discussion. I'm funny that successful nan lawsuit if nan median PFS use is little than 1.5 months complete chemo, would nan regulatory agency put much weight connected evaluating little benefit? Thank you.

Anna Berkenblit

So Kelly, I really can't reply your mobility because nan constituent estimate for nan median, if nan constituent estimate for nan medians are little than 1.5 months, that doesn't show maine nan totality of nan curen of mirvetuximab complete interrogator prime chemotherapy, wherever hazard ratio is nan astir due statistical measure. And so, what I would opportunity is we expect a statistically important betterment successful progression-free endurance pinch a p-value little than 0.05.

And nan constituent estimates for nan median for each limb will beryllium what they will be. And past wide endurance will surely beryllium portion of nan wide appraisal that FDA does erstwhile they look astatine use risk.

Kelly Shi

That's helpful, convey you.

Operator

Thank you. Our adjacent mobility comes from nan statement of Asthika Goonewardene pinch Truist. Your statement is now open.

Asthika Goonewardene

Hi bully greeting guys and acknowledgment for taking nan questions. Quick 1 connected nan ELAHERE commercialized rollout [indiscernible] suggested that 1 of your diagnostic vendors, NeoGenomics, has immoderate issues pinch processing, and this was causing immoderate delays successful testing around. But arsenic acold arsenic we understand that these issues person precocious been resolved. I conscionable want to corroborate that this is so nan lawsuit and that location is, nary testing bottlenecks now?

And past related to that, was nan $30 cardinal to $35 cardinal guidance of ELAHERE income for this twelvemonth based connected income made during that play erstwhile you had this bottleneck aliases is it purely taking into relationship nan much caller tally rate? And past I person a speedy follow-up?

Mark Enyedy

Yes, truthful nary bottleneck successful testing. All 4 of nan cardinal labs are up and doing very robust business. The 4th laboratory is simply a mini location laboratory successful Las Vegas. But nan 3 cardinal labs, which see Labcorp, NeoGenomics arsenic you mentioned, successful cares, are doing ample volumes of testing, and there's nary bottleneck. We've not fixed gross guidance for ELAHERE, and we've deliberately done that fixed nan early days of nan launch.

Obviously, galore of you person provided your ain estimates, and we look guardant to reporting retired information connected a quarterly ground arsenic we move forward. What we're trying to do pinch you is springiness you a qualitative appraisal of really nan motorboat is proceeding based connected what we deliberation are nan important metrics. And so, arsenic we've discussed, testing has exceeded our expectation. Adoption successful nan organization has exceeded our expectation.

Our world accounts are our largest accounts, arsenic we would person anticipated. And we proceed to activity nicely done nan sum decisions, and we started pinch a beardown guidelines astatine nan opening of this year, and Tom and his squad person done an exceptional occupation successful position of improving some our Medicare and commercialized coverage.

The engagement pinch nan compendia has been affirmative to see nan combination. So each of nan things that we would dream for, arsenic a caller entrant successful nan marketplace person materialized nicely and our extremity yet is to study retired nan quantitative metrics to spell on pinch these qualitatives successful regular bid pinch - successful relationship pinch nan adjacent net call.

Asthika Goonewardene

Okay, great. Just my speedy follow-up past is of nan 1,500 diagnostic tests that were - patients that were screened, and possibly if you tin springiness immoderate colour connected much caller numbers, too. About what percent of them were from patients who are presently connected a first aliases 2nd statement therapy for ovarian cancer? Just trying to spot there's a measurement for america to backmost retired what nan much contiguous pent-up request could be? Thanks.

Todd Talarico

Well, we don't precisely cognize astatine what authorities each diligent is at. I deliberation what we recovered successful nan opening was that we did person a batch of patients that were waiting for this product. So nan testing early connected was straight related to a platinum-resistant diligent that was owed to move connected therapy. But arsenic Mark alluded to earlier, nan testing has been shifting and physicians are moving earlier, and practices are moving earlier to earlier diagnosis. And so, really difficult for america to find nan existent spot successful therapy for erstwhile nan testing really occurred.

Asthika Goonewardene

Thanks, I admit nan color.

Operator

Thank you. Our adjacent mobility comes from nan statement of Daniel Wolle pinch JPMorgan. Your statement is now open.

Daniel Wolle

Good morning, convey you for taking my question. Two questions first, regarding nan Vertex agreement, considering caller attempts to usage ADCs for conditioning by going after, for example, CD117. How differentiated are immoderate of nan targets you aliases Vertex are going after? And 2nd question, knowing that - it's only been a fewer months for ELAHERE, but fixed that it's a driblet shipment based ordering, what's your visibility connected nan persistence of use?

Mark Enyedy

Right, truthful arsenic it relates to Vertex, we're not astatine liberty to remark connected nan targets, different than to opportunity that these are being utilized successful conjunction pinch their cistron editing programs, and we're very pleased to beryllium partnering pinch a institution nan value of Vertex. And past successful position of persistence, again, it's early. I mean, what we tin opportunity is simply a important and increasing percent of nan orders are repetition orders aliases accounts who are repetition ordering. So, we're evidently very encouraged by that. But again, we conscionable don't person a model into nan what - really nan long of therapy astatine this point.

Daniel Wolle

Great, convey you.

Operator

Thank you. Our adjacent mobility comes from nan statement of Jonathan Chang pinch SVB Securities. Your statement is now open.

Jonathan Chang

Hi guys, acknowledgment for taking my questions. First question, tin you supply much colour astir erstwhile this twelvemonth we could get nan ELAHERE merchandise gross guidance? What would request to hap first earlier you're successful a position to springiness guidance here? And past second, congrats connected nan Vertex partnership. Can you talk astir really you're reasoning astir different options for extending nan rate runway? Thank you.

Mark Enyedy

Yes, truthful I think, realistically, Jonathan, we'd for illustration to person 2 coagulated quarters nether our loop earlier providing guidance. So I could imagine, arsenic we study retired our 2nd 4th net precocious successful July aliases successful early August that we would beryllium successful a position to springiness immoderate guidance. And astatine that point, we would person immoderate of nan accusation that we're - that galore of you are reasonably asking astatine this point, what's your long of therapy, really do you deliberation astir nan accounts, wherever is nan business coming from.

And I deliberation we'll person a overmuch clearer thought connected that and besides nan spot of nan trends, a amended evaluation. We person a going successful position pinch respect to nan worth of individual targets successful position of anticipated diligent starts, revenue, et cetera, and titrating those information and are each really important.

And past sorry, Jonathan, nan 2nd question? Cash one, correct Yes. So nan first constituent to make is wherever we are pinch rate and rate equivalents and nan exertion of nan auditing test. We shared successful this greeting that -- we will beryllium sharing successful our SEC filing, and that creates a going interest business for nan business. But that measurement excludes -- erstwhile you're successful a motorboat shape for illustration we are, it excludes fundamentally each merchandise revenue. They possibly springiness you in installments for pennies connected nan dollar.

So what we want to make judge that group understood intelligibly was that pinch nan summation of our expected ELAHERE gross that we've sewage importantly much than 12 months' worthy of rate for nan business. That said, we are evaluating further options to finance nan business, which would include, for example, royalty financing pinch respect to nan anticipated maturation of nan product, and there's liking there. And past much classically follow-on offerings for nan business and perchance moreover a humble magnitude of debt.

So those are things that we're each evaluating. But I think, again, nan astir important constituent for everyone present is erstwhile we look astatine our business scheme to see cash, rate equivalents, anticipated gross from ELAHERE, and also, we've sewage this very wide portfolio of partnering agreements that see aggregate folks pinch very progressive programs to include, for example, [indiscernible], who expects to record pinch nan Chinese FDA that we would get a milestone costs upon filing, and that's coming successful nan 2nd half of this year.

So each that worldly gets excluded from nan accounting analysis, but erstwhile we look astatine nan afloat business plan, we've sewage much than 12 months of cash.

Jonathan Chang

Got it. Thank you.

Operator

Thank you. Our adjacent mobility comes from nan statement of Peter Lawson pinch Barclays. Your statement is now open.

Peter Lawson

Great. Thanks for taking nan question. Just nan plans astir nan build retired for nan commercialized infrastructure successful nan EU. And does your disbursal guidance see that EU court?

Mark Enyedy

It does, it does. I mean, obviously, successful 2023, that's going to beryllium beautiful limited. So we do have, up of our world business, we person a mighty one-room agency successful Zug arsenic we speak, which is nan commencement of what we're doing. .But nan MAA filing would travel later successful nan year. Approval would travel successful 2024. And for galore of you who person knowledgeable pursuing products being launched successful Europe, nan existent motorboat and commercialized income are sequenced according to reimbursement astatine a nationalist level.

So for illustration galore companies, we expect to commencement pinch Germany, but that would beryllium very precocious successful 2024. So we tin attack this successful a very judicious way. Obviously, we've had immoderate very robust objective improvement successful Europe from each of our pivotal studies and will person for GLORIOSA and 420 arsenic well.

So nan acquisition guidelines among ovarian crab treaters successful Europe is already beautiful rich | arsenic it relates to ELAHERE use. So I deliberation we commencement pinch a beardown guidelines -- it's a very concentrated market, Peter, truthful nan past marketplace investigation we did, conscionable looking astatine nan cardinal 5 countries, much than 70% of patients are treated astatine conscionable 65 centers. And of course, we've sewage a important overlap pinch those centers successful position of wherever we've gone pinch our objective trial.

So again, we are approaching this successful a judicious mode and nan incremental commercialized finance required to pat into a marketplace pinch that level of attraction is very manageable.

Peter Lawson

Got you. And past conscionable arsenic regards to diagnostic testing, really is that going? Any wrinkles that developed? Or is it going smoother than expected, conscionable immoderate specifications astir that.

Mark Enyedy

Yes. So we had a chance to drawback folks up a small spot earlier connected nan call, I think, earlier you joined, Peter. But nan testing, frankly, has conscionable exceeded our expectations. So we did 1,500 tests betwixt nan support day and nan extremity of nan year. The measurement of testing has increased. The easiness of testing has not proven to beryllium a obstruction to entry. And I'll conscionable repetition what I said earlier, which was this is simply a expert guidelines that is highly accustomed to testing.

In fact, their receptivity to it exceeded our expectation, and that's because they started retired much than half a decade agone looking for BRCA mutations, moved connected to homologous recombination deficiency testing. And truthful nan layering successful of folate receptor alpha has proven to beryllium rather easy for these folks. They've integrated it. And what we're seeing is simply a important percent of recently diagnosed patients being assessed for their FR alpha status, which we deliberation is very encouraging.

Peter Lawson

Got it. Thank you. And I'm judge spot been done before. But conscionable astir nan alteration successful nan guidance successful MIRASOL from early '23 to 2Q. Any benignant of method reasons astir that? Or was it benignant of a longer-than-expected clip framework to summation PFS events?

Anna Berkenblit

Yes. So somewhat longer play to get nan PFS events we primitively had guided to earlier nan extremity of December successful 2022, and now we're imminent. So our models are arsenic bully arsenic they tin be. And clearly, our models weren't perfect. And there's different reasons you could speculate. Maybe nan patients connected mirvetuximab are doing a spot better. Maybe nan patients connected IC chemo are doing a small spot better. Maybe each of nan patients are doing a small spot better, and possibly there's a operation of each of these factors. So I don't know, not worried. Imminently, we will trigger nan last PFS analysis.

Peter Lawson

Great. Thanks truthful much.

Operator

Thank you. This concludes nan Q&A session. I would now for illustration to manus nan convention backmost complete to nan squad for closing remarks.

Mark Enyedy

Great. Well, convey you very overmuch for joining america today. As you tin perceive from nan comments here, there's a batch of excitement for nan business arsenic we travel into 2023 and look astatine nan twelvemonth ahead. The motorboat is exceeding our expectations, and we person a number of important readouts upcoming, truthful look guardant to talking to you arsenic we activity done those information and study retired consequent earnings.

So acknowledgment very much.

Operator

This concludes today's convention call. Thank you for participating. You whitethorn now disconnect.

Editor: Naga



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