ImmunoGen Inc (IMGN) 2018 Q1 法說會逐字稿

Good day, everyone, and welcome to the ImmunoGen First Quarter 2018 Financial Results Conference Call. Today's call is being recorded. At this time, for opening remarks and introductions, I'd like to turn the call over to today's host, Sarah Kiely, Investor Relations. Please go ahead.

Good morning, and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent progress and first quarter 2018 operating results. This press release and a recording of the call can be found under the Investors section of our website at immunogen.com.

On the call today are our President and CEO, Mark Enyedy; our Chief Medical Officer, Anna Berkenblit; and our CFO, Dave Johnston. Rich Gregory, our Chief Scientific Officer, will join the team for the Q&A session.

During today's call, we will highlight key recent accomplishments, review first quarter financial results and outline milestones for the remainder of the year.

During the call, we will use forward-looking statements, and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in ImmunoGen are included in our SEC filings.

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

Thank you, Sarah. Good morning, everyone, and thank you for joining us today. Building on the momentum we generated in 2017, we started this year with a number of important milestones, highlighted by significant progress with our lead candidate mirvetuximab soravtansine for the treatment of women with ovarian cancer. As a reminder, our efforts at ImmunoGen focus on 4 strategic priorities: First, complete the development and launch mirvetuximab by 2020; second, accelerate our pipeline of novel IGN programs; third, build on our leadership position in ADCs through continued innovation; and fourth, expand the reach of our innovation and maintain financial strength through high-value partnerships.

Over the first 4 months of 2018, we've made significant progress towards each of these objectives. With mirvetuximab, we were pleased to report last week that we've completed patient enrollment in FORWARD I, our Phase III registration trial, designed to support full approval of mirvetuximab in platinum-resistant ovarian cancer well ahead of schedule. This accelerated accrual reflects the increased interest in mirvetuximab from the ovarian cancer community and the need for new treatment for women with platinum-resistant disease.

We also successfully completed the prespecified interim futility analysis following AD progression-free survival events in FORWARD I. The study will continue its plan without modification based on the recommendation of the independent data monitoring committee, and we are on track to report top line results from this study in the first half of 2019.

In addition to advancing mirvetuximab as a single-agent therapy, we are evaluating combination regimens to expand the eligible patient population and move into earlier lines of treatment for ovarian cancer in our FORWARD II trial.

At SGO in March, we presented additional positive data from the cohort assessing mirvetuximab in combination with Keytruda. Anna will review these data with you in more detail shortly.

We also look forward to sharing maturing efficacy and safety data from the mirvetuximab plus Avastin expansion cohorts in roughly 50 patients this June at ASCO.

Moving to our earlier-stage portfolio, accrual continues in a nice pace in the dose-escalation studies for our IGN programs, and we expect to report data from both programs at ASH later this year.

In addition, earlier this month, we presented 3 posters at AACR, highlighting our ongoing innovation in ADCs, including advancements in payloads for enhanced antitumor activity as well as insights into factors that determine the clinical efficacy of ADCs.

So overall, sound execution across the business to start the year.

With that, I will turn the call over to Anna to provide a more detailed update on our clinical programs.

Thank you. As Mark mentioned, we are very pleased to have passed the interim analysis for futility in FORWARD I and that the Independent Data Monitoring Committee recommended to continue the study as planned. The primary endpoint in FORWARD I is progression-free survival or PFS in both the entire study population or the intent to treat population that includes both medium and high folate receptor alpha expressors. And in the subset of patients with high folate receptor alpha expression.

Last week, we also completed full enrollment in FORWARD I 2 months ahead of schedule. We are on track to report top line data in the first half of 2019. The readout is event driven and will be based on 236 PFS events.

Based on the encouraging and consistent safety and activity profile observed in clinical studies to date, we believe that mirvetuximab has the potential to displace chemotherapy as a single-agent treatment in the platinum-resistant setting.

Beyond FORWARD I, we are conducting the FORWARD II trial, evaluating mirvetuximab in multiple combination cohorts, to expand its benefit into platinum-sensitive disease and position it as an earlier-line therapy.

To date, we have shown that full-dose mirvetuximab can be combined safely with full doses of Avastin, carboplatin and Keytruda, with favorable tolerability, consistent with the known safety profiles of each agent. Over the course of this year, we will have multiple data readouts from FORWARD II, culminating in data reported in more than 100 patients, who have received mirvetuximab in combination with Avastin or Keytruda.

We believe this growing body of clinical data will support further development of mirvetuximab in combination regimens and lay the foundation for mirvetuximab's expanded use in ovarian cancer.

More recently at SGO, we presented data on 14 patients from the Keytruda dose-escalation cohorts. As a reminder, these are heavily pretreated patients with platinum-resistant ovarian cancer. Patients in this cohort have received a median of 4.5 prior lines of therapy with 64% of patients receiving 4 or more prior lines.

For all patients, the confirmed overall response rate was 43% with a median progression-free survival of 5.2 months and the duration of response or DOR of 30.1 weeks. Notably, in the subset of patients with medium or high folate receptor alpha expression levels, the confirmed overall response rate was 63% with a median PFS of 8.6 months and a DOR of 36.1 weeks. This was just 8 patients, but it's very encouraging. And based on these data, we are now enrolling an additional 35 patients with medium or high folate receptor alpha expression levels in an expansion cohort in the FORWARD II study.

These data show early evidence of antitumor activity and durable responses, and we're pleased with the tolerability profile of the combination of these 2 agents. We are particularly encouraged by the data in the subset of patients with medium or high folate receptor alpha expression, in whom we saw the greatest activity. The consistency of our findings with mirvetuximab underscores its potential to treat ovarian cancer both as monotherapy and in combination with other treatments in earlier lines of care.

As we look ahead, we will be presenting maturing safety and efficacy data from the mirvetuximab plus Avastin expansion cohort in over 50 patients as a poster at ASCO in June. We look forward to sharing more details on this cohort in the weeks ahead.

We also plan to submit an abstract for presentation at ESMO, in October, to report initial data from the Keytruda expansion cohort, which will include 35 patients with medium or high folate receptor alpha expression.

Earlier this year, we also expanded the FORWARD II study to include an additional expansion cohort evaluating a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive disease. Given the relatively high response rates observed in mirvetuximab plus carboplatin and the durability of responses, we think it will be into 2019 before we would have initial data on this triplet combination.

Beyond our internally sponsored mirvetuximab studies, there are several investigator-sponsored trials ongoing with the National Comprehensive Cancer Network to evaluate mirvetuximab in other tumor types expressing folate receptor alpha, including triple-negative breast cancer and other gynecologic malignancies. We are also cosponsoring a study with Clovis, which evaluates mirvetuximab in combination with Rubraca in ovarian cancer. We expect data from these studies to help guide the broader development of mirvetuximab to reach as many patients as possible who may benefit from treatment.

I'll also briefly touch on our IGN program; IMGN779 and IMGN632, which are both in Phase I dose-finding evaluations. As a reminder, the IGNs are a novel class of DNA-acting payloads that we developed. We've demonstrated preclinically that they are just as active in terms of killing tumor cells as other DNA-acting agents that cross link, for example, PVDs. But because the IGN's alkylate or damage one strand of DNA, it is easier for normal cells to repair, and therefore, there is a potential for a better therapeutic window, the ability to repeat dose and to dose higher. And thus far, in our clinical evaluation, we have not seen any dose-limiting toxicity.

IMGN779 is an ADC directed at CD33, which we are assessing in relapsed refractory AML. We are continuing to dose escalate with both our biweekly and weekly dosing schedules. Our goal for this year is to get to a recommended Phase II dose, and we plan to submit an abstract for presentation at ASH this December.

In addition to IMGN779, we are also developing an ADC that targets CD123, which we call IMGN632. IMGN632 is being assessed in AML and blastic plasmacytoid dendritic cell neoplasm or BPDCN. We dosed the third patient in January and are progressing with a standard 3-plus-3 dose-escalation design. We expect to have the first data from this program, which would include safety, PK, PD and whatever activity data we'll have also at ASH in December.

In closing, we are very encouraged by the progress with our mirvetuximab program in ovarian cancer. With enrollment complete in FORWARD I, we are working toward top line data in the first half of next year, and we look forward to sharing additional FORWARD II data with you in the coming months. We'll also be keeping you updated on the progress with IMGN779 and IMGN632 with data planned for both at ASH.

Now I'll turn the call over to Dave to review our financials.

Thanks, Anna. Our financial results were detailed in this morning's press release, so I'll review just the highlights. We continue to operate with financial discipline and remain focused on executing against our strategic priorities related to mirvetuximab, our earlier-stage IGN programs, our research portfolio and our partners.

Revenues for the quarter are $19.8 million, which were largely noncash as detailed in the press release.

Operating expenses in the first quarter of 2018 were approximately $56.6 million and this included $45 million in R&D expenses, driven by increased clinical trial and drug supply costs, related to the mirvetuximab, FORWARD I Phase III clinical trial. Operating expense in the first quarter also included a $1.7 million restructuring charge due to the workforce reduction related to the decommissioning of our Norwood facility. The increase in operating expense, again driven by R&D costs associated with our late-stage clinical trial, along with lower milestone payments from our partners in this quarter, resulted in cash used in operations a bit less than $50 million. We ended the first quarter with $218 million of cash and cash equivalents.

We're updating our guidance EBIT for the year. And for the year 2018, we expect revenues to be between $60 million and $65 million, which is no change to previous guidance.

Operating expenses, we expect to be between $200 million and $205 million, which represents an increase of about $15 million, driven largely by noncash stock compensation and accelerated depreciation, once again associated with our Norwood phaseout.

And lastly, our year-end cash guidance remains unchanged at $115 million to $120 million. We expect that our current cash, combined with expected cash revenues from partners and collaborators, will fund our operations into the fourth quarter of 2019, which will take us through a number of important milestones, including top line FORWARD I results.

So with that, let me now hand the call back over to Mark.

Thanks, Dave. With a strong start to the year, we are also looking forward to a number of meaningful milestones for the remainder of 2018. Anna highlighted the upcoming data readouts in our mirvetuximab program, including planned presentations at both ASCO and ESMO from FORWARD II.

Beyond mirvetuximab, we plan to report data from the 2 Phase I studies with 779 and 632 at ASH in December. In addition, our internal preclinical pipeline and partner programs are continuing to progress and strengthen our leadership position in the ADC space. We expect to initiate IND-enabling activities for our novel ADAM9 program in collaboration with MacroGenics before the end of the year and anticipate that Takeda will dose its first patient this quarter with TAK-164, a GCC directed ADC being evaluated in gastric and colorectal cancers. This will be the first ADC using our IGN payloads to move into a solid tumor indication.

We also continue to add world-class talent to lead various functions for ImmunoGen during this moment in the company's evolution. We were pleased to recently announce the appointment of Blaine McKee to our management team in the new role of Chief Business Officer. Blaine and I have worked together for over the last 20 years in roles at Genzyme and Shire and he joins us from Shire where he most recently served as Head of Corporate Development. He brings 25 years of experience building successful biotechnology companies and has extensive strategic, transactional and market access experience. In this role, Blaine will be instrumental in leading our transition to a fully integrated company as well as advancing our corporate development activities.

We also recently announced the appointment of Stuart Arbuckle to our Board of Directors. Stuart's international and oncology commercial experience at Vertex and Amgen will contribute significantly to the launch of mirvetuximab and as we more generally evolve into a business with marketed products.

In sum, we entered 2018 from a position of strength. Our lead program is on track with multiple data readouts and operational milestones planned this year. Our earlier-stage portfolio is accelerating with programs integrating our latest innovations, and we are operating from a solid financial base. With the benefit of this momentum and a number of near-term catalysts, we anticipate another exciting and productive year in 2018 at ImmunoGen. We look forward to seeing you all at ASCO and keeping you updated on our progress throughout the remainder of the year.

That concludes our prepared remarks, and we'll now open the call for any questions.

(Operator Instructions) And we will take our first question from Jessica Fye with JPMorgan.

Just a couple of questions. You mentioned the collaboration with Clovis. Can you talk about when we can expect to see human data in combination with PARP. And then, I know you talked in the past about potentially entertaining a partnership from mirvetuximab say in Europe. As you get closer to data, would you still entertain partnering this asset prior to data or at this point, would you want to wait until after to capture more value?

Jess, I'll take the first question and then turn the second one over to Mark. So we are cosponsoring an investigator-sponsored trial with Clovis. They're providing Rubraca and we are providing mirvetuximab. This is an IFT that's being performed at Ohio State University. And since it's an IFT, we are having the investigators conduct the study and the timing of the study in terms of enrollment and then data completion is up to them. But they will be providing updates to us on a regular basis.

Jess, I mean, I think, the predicate to your question is, right, which is that, if we were to partner mirvetuximab in Europe, the likely highest value from that partnership would come post the data readout from FORWARD I. So we do have inbound interest. It's our responsibility to -- is to monitor the market, but I agree with you that the likely outcome here, if we were to partner, would be post the data readout. And as we've discussed previously, from our perspective, we would need to be able to convince ourselves and our shareholders that anything that we did with a partner would enhance the value of the program, which means that the partner would need to subscribe to a broad vision of the program and enable us to do things that we may not have as the highest priority at the current time. So for example, a potential expansion into other indications such as lung cancer. So I would just say, stay tuned to that. We've done a benchmarking exercise that supports our ability to launch this product in the European market. That said, we would be prepared to entertain potential partnering discussions but again those would likely be post readout.

And we'll take our next question from David Huang with Canaccord Genuity.

This is David Huang on for John Newman. So just quickly, can you talk about the difference in prior lines of therapy for mirvetuximab plus Avastin data at ASCO versus the prior data? And do you expect that most of the patients at ASCO will have received Avastin previously?

So the data we presented previously was just on 14 patients, and they had a median number of prior therapies of 6 with a range of 2 to 8. In the expansion cohort, we allowed up to 5 prior lines of therapy. So it will be a less heavily pretreated population. In addition, we had some patients, who had prior mirvetuximab and some who didn't. So we'll be presenting the data at ASCO accordingly.

And we will take our next question from Andy Hsieh with William Blair.

I have 2. First is for Anna. Based on what you had seen from the FORWARD II study with mir plus pembro, do you think it makes sense going forward to limit the number of prior lines of therapy, kind of like what you guys have done with FORWARD I?

So certainly that is an option for us. Right now, we are in the midst of finishing enrollment really in pembrolizumab combination, and we'll be presenting data at ESMO. So based on those data, we will make further decisions around the best registration strategy for that combination. Certainly, could be in later line. On the other hand, we may decide the earlier line makes more sense. We'll just have to wait and see how the data mature, Andy.

Okay, great. So second question has to do with milestones. So Dave, in terms of Takeda starting dosing, do you expect any milestone payments? And secondarily, in terms of severance, do you foresee another round of onetime payments? Just housekeeping modeling questions.

Yes, to answer the first one, yes, there will be a milestone that will be -- it's not disclosed how much that is, but it's not going to be earth-shattering to put it that way. But it will be a cash milestone, and I expect that we would see it in the next quarter's call. In terms of severance, you are talking about associated with the Norwood shutdown, I am assuming...

That's correct. That's correct.

Yes. So that gets -- that will be spread a bit over the year. The bulk of it was in the first quarter. You saw that $1.7 million restructuring fee, but there's other payments like retention for Aktie employees, which will be showing up over the remaining quarters, but it won't be as large.

And we'll take our next question from Debjit Chattopadhyay with H.C. Wainwright.

So for the CD123 program, CD123 expression seems to correlate with NPM1, and I think FLT3 as well. And now that you have a FLT3 agent approved, is that changing your thought process around the development equation for that?

Debjit, certainly, we are thinking ahead in terms of combinations, but this year, right now, we're focused on identifying really the maximum tolerated dose as monotherapy. As you may recall, we just started dosing in January in a 3-plus-3 dose-escalation design, and we'll be presenting initial data from CD123 at ASH this year. But we're always from a preclinical perspective thinking about what data package we need to support combinations in the clinic.

Well, the reason I ask is, because given that CD123 is a fairly active target. There is some early data from peers. Looks like it works. But there is also this precedence set by FDA with GlycoMimetics asking for an overall survival endpoint in the Phase III, not a CR plus CRi. So one, was that primarily because GM1271 was trying to make the induction regimen more tolerable, so you wouldn't really see the effect and response rate, but in overall survival, whereas in case of CD123, it could be still CR plus CRi based approval from -- in a relapse refractory setting. And then, in the combos scenarios, do you -- I know it's out there, but in a combo scenario, does it have to be CR/CRi or then it -- FDA really insists on an overall survival kind of an endpoint?

So, Debjit, we at ImmunoGen have not yet engaged the regulators on the registrational path options for our CD123 compound. What I can say is in the relapsed refractory setting, overall survival has typically been the appropriate endpoint for approval. And certainly, the ODACs that occurred around event-free survival, there the focus was on what an endpoint would be in the first line setting. So we will certainly follow the regulatory trends as our programs pass through -- develop through the clinic and proceed accordingly.

Okay, great. And then, one final one. In terms of the Keytruda combo, I assume there is a Steering Committee with Merck, your collaborator Merck rather. How often does that committee meet and -- in terms of, as this program expands, what's the next step forward for the collaboration with Merck. I mean, do you have an internal champion based on the fairly encouraging data that you presented this year at the SGO.

So you may recall that the collaboration we have with Merck is a drug-only collaboration. And I believe we're one of probably 200-ish studies that Merck has arranged in this format to supply drug only. That being said, the data that we presented at SGO from the escalation cohort are quite interesting. And certainly, the expansion cohort data at ESMO if they continue to hold up should garner continued enthusiasm broadly for this doublet and potentially, there are other options even in terms of combining with carboplatin agent as a triplet and that triplet could have opportunities in other diseases, including lung cancer. So all I say is, if the data holds up, I think the interest will as well.

I mean, just to add to Anna's comments, we do meet regularly with Merck to review the data in the study and they share our encouraging perspective on the data. It looks quite good. And we will continue to monitor it as we complete enrollment in the expansion cohort and look to report out that data later this year ideally at ESMO.

(Operator Instructions) And we'll take our next question from Biren Amin with Jefferies.

On FORWARD I, I now that the trial is fully enrolled, do you plan to provide us with baseline characteristics prior to data readout in the first half? And I guess, can you just talk about if the patients enrolled in FORWARD I were similar to the Phase II trial on baseline?

So we do not plan to disclose any data from the Phase III FORWARD I study until we have top line data from the final analysis. That being said, we've been very clear that the key demographic baseline characteristics for eligibility, are platinum-resistant disease, 1 to 3 prior lines of therapy and folate receptor alpha expression median were high. And we have defined that in the Phase III trial exactly as we defined it in the pooled analysis where we basically define the population, we will go into Phase III with. And we've been monitoring the patient's characteristics as they have been enrolling. And we have enrolled the patients, who we anticipated we would enroll.

Got it. And then, on FORWARD II, now that you have 50 patients with data with combo bev. What do you anticipate are the next steps for this combo?

So there are a couple of options. And from a registration strategy perspective, we could certainly entertain a Phase III trial. Alternatively, since Avastin has already proved in the U.S. in combination with chemotherapy in platinum-resistant disease, another viable strategy would be to continue to gather patient data in platinum-resistant population and if it continues to hold up, then compendia listing in NCCN guidelines would be an option to support reimbursement in the U.S. So we have a couple different options that we're considering internally.

Have you discussed with the FDA on potential next steps?

Not at this point. But certainly, that's part of our plan.

(Operator Instructions) And we'll take our next question from Mara Goldstein with Cantor Fitzgerald.

I had a question on the data that has been generated thus far on the mirvetuximab plus pembro data. And in that subgroup of medium to high expressors for folate alpha. There were some differences between sort of the medium expressors and the high expressors. And I know the patient numbers were really small in that cohort, but I'm wondering if there is any rationale for why you would see that difference between medium and high in terms of those responses that were observed?

So at SGO, we presented initial efficacy data from 14 patients in dose escalation. And the overall response rate in those 14 patients was 43%. When we looked at the subset of 8 patients with medium or high FR alpha expressions that was 63% as a response rate. So 5 out of 8 patients had a confirmed response. Given the small number, I would not speculate on the difference between medium or high in that subgroup.

Okay. And then just with mirvetuximab, I believe there were some IFT studies, one in triple-negative breast cancer and one on -- are there any expectations around any data for those from a timing perspective?

Again, these are investigator-sponsored trials, and the investigators are responsible for enrollment. So they share data with us. And what I can tell you is the triple-negative breast cancer trial is enrolling, and when they have data, they will share it.

And it appears there are no further questions at this time. I like to turn the call back to our presenters for any additional or closing remarks.

Great. Well, thanks, everyone, for your time today and we look forward to seeing you at ASCO and keeping you updated on our progress throughout the remainder of the year. Thanks.

And ladies and gentlemen, that does conclude today's conference. I like to thank everyone for their participation. You may now disconnect.