Immunogen Inc (IMGN) Q2 2019 earnings call dated Aug 02, 2019
Corporate Participants:
Courtney O’Konek — Senior Director of Corporate Communications and Investor Relations
Mark J. Enyedy — President and Chief Executive Officer
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Analysts:
John Newman — Canaccord Genuity — Analyst
John Scott — Cowen and Company — Analyst
Kennen MacKay — RBC Capital Markets — Analyst
Andy Hsieh — William Baird — Analyst
Aaron Welch — HC Wainwright — Analyst
Daniel Wolle — JP Morgan — Analyst
Biren Amin — Jefferies — Analyst
Jonathan Chang — SVB Leerink — Analyst
Michael Schmidt — Guggenhiem Partners — Analyst
Presentation:
Operator
Good day, and welcome to the ImmunoGen Second Quarter 2019 Conference Call. [Operator Instructions]
At this time, I’d like to turn the conference over to Courtney O’Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
Courtney O’Konek — Senior Director of Corporate Communications and Investor Relations
Good morning, and thank you for joining. Earlier today we issued a press release that includes a summary of our recent progress and second quarter 2019 financial results. This press release and a recording of this call can be found under the Investors & Media section of our website, at immunogen.com.
On the call today are Mark Enyedy, our President and CEO; and Anna Berkenblit, our Chief Medical Officer. Dave Foster, our Chief Accounting Officer, will also join us for Q&A.
During today’s call we will review recent progress, our second quarter financial results and highlight upcoming milestones. During the discussion 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.
And with that, I’ll turn the call over to Mark.
Mark J. Enyedy — President and Chief Executive Officer
Thanks, Courtney. Good morning, everyone, and thank you for joining us today. During the second quarter we fundamentally restructured the business at ImmunoGen, with a focused set of strategic objectives, a prioritized portfolio of four innovative product candidates and a strong cash position that will enable us to advance these programs through their next phases of development. We look forward to a productive second half of the year with a number of important milestones for the company.
Starting with mirvetuximab, with the benefit of the safety and efficacy data we’ve generated to-date, we believe mirvetuximab has the potential to displace single-agent chemotherapy in ovarian cancer patients with high FR alpha positive, platinum-resistant disease and to serve as the preferred partner for combination regimens across multiple lines of therapy. To achieve these objectives, we are pursuing a comprehensive development plan to obtain initial approval as a single-agent in the platinum-resistant setting followed by label expansion into earlier lines of treatment through combination studies.
For monotherapy, we are finalizing the design of our registration study, which we expect to review with regulators and initiate patient enrollment before the end of the year. In addition, we will share the full data from FORWARD I during an oral presentation at ESMO at the end of September.
In parallel, we continue to advance our combination cohorts, with encouraging data from the Avastin combination presented at ASCO in June, which Anna will review in a moment. We will also present initial data at ESMO from our triplet combining mirvetuximab with carboplatin and Avastin in earlier line patient. Finally, we anticipate completing enrollment in our second mirvetuximab plus Avastin cohort in patients with recurrent ovarian cancer regardless of platinum status later this quarter.
Moving to our earlier-stage portfolio, we’ve made significant progress with IMGN632, our anti-CD123 ADC, which we are developing in AML and BPDCN under our collaboration with Jazz. Over the last quarter, we have determined the recommended Phase II dose for this program and have filed a new protocol to move forward with combination studies in relapsed/refractory AML, as well as in front-line patients with minimal residual disease following induction therapy. In addition, we will continue to enroll relapse/refractory BPDCN patients under our existing protocol. We will share data from both AML and BPDCN patients at ASH in December.
Finally, we continue to advance IMGC936, our novel ADAM9-targeting ADC being co-developed with MacroGenics, toward the clinic, as well as completing the activities needed to transition our next-generation antifolate receptor alpha ADC into preclinical development next year. So significant progress with the portfolio and a number of important milestones over the remainder of the year.
Turning to our financial results, which we detailed in the press release issued this morning, during the second quarter we generated $15.5 million in revenue, which included a $5 million milestone payment from Roche and $10.4 million in non-cash royalty revenues related to Kadcyla.
Operating expenses were approximately $57 million, comprised of $29 million in R&D expenses, compared with $39 million for the same quarter in 2018. The decrease was primarily driven by lower personnel expenses, as well as lower clinical trial costs, compared to the prior year, when these expenses were driven by accelerating patient accrual in FORWARD I; a $19 million restructuring charge principally related to the workforce reduction in conjunction with our operational review; and $9 million in G&A expenses, which were level with the prior year. We ended the quarter with approximately $240 million in cash on the balance sheet.
We’re updating our financial guidance today. For the full-year, we expect revenues to be between $40 million and $45 million; our operating expenses to be between $175 million and $180 million; and our cash at year-end to be between $165 million and $170 million.
With that, I’ll turn the call over to Anna to review our pipeline progress in more detail. Anna?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Thanks, Mark. Looking first at mirvetuximab monotherapy, we look forward to meeting with the FDA this quarter to discuss the design of the registration trial and anticipate being able to provide additional details regarding this when we announce the full FORWARD I data at ESMO. We also plan to seek protocol assistance from the EMA prior to initiating the Phase III trial, which we are on track to do before the end of this year.
Turning now to combinations, as mentioned, we recently announced mature data at ASCO from the FORWARD II expansion cohort evaluating mirvetuximab in combination with Avastin in patients with FR alpha positive platinum-resistant ovarian cancer. We were pleased that this combination in this population continues to demonstrate encouraging antitumor activity with durable responses and a favorable tolerability profile, particularly among patients with medium or high levels of foliate receptor alpha expression, who have received up to two prior lines of therapy, as our data compare favorably to that of Avastin with chemotherapy in the AURELIA trial. We remain focused on establishing mirvetuximab as the combination agent of choice in ovarian cancer, supporting its use in earlier lines of therapy.
The mature data presented at ASCO support further exploration of this doublet in the platinum-agnostic cohort that is finishing up enrollment this quarter, as well as the ongoing expansion study evaluating a triplet combination of mirvetuximab with Avastin and carboplatin in patients with platinum-sensitive disease. We look forward to presenting initial FORWARD II triplet safety and response rate data at ESMO in September, along with full FORWARD I data.
Moving now to our early stage portfolio. IMGN632 is being evaluated for the treatment of hematological malignancies, with a focus on AML and BPDCN. IMGN632 is a CD123-targeting ADC that deploys our most potent IGN payload. And during this quarter patient enrollment continued in our expansion cohorts of the Phase I study in patients with relapsed or refractory AML and BPDCN. We look forward to sharing updated data from the ongoing clinical trial of IMGN632 monotherapy along with preclinical data combining IMGN632 with azacitidine or venetoclax at ASH, should our abstracts be accepted for presentation.
We also advanced two additional assets that demonstrate our continued innovation in ADCs: IMGC936, which is in co-development with MacroGenics, and our next-generation antifolate receptor alpha ADC, which is expected to enter development in mid-2020.
With that, we’ll open the call for questions.
Questions and Answers:
Operator
Thank you. [Operator Instructions] Our first question comes from the line of John Newman from Canaccord. Please go ahead, your line is now open.
John Newman — Canaccord Genuity — Analyst
Hey, good morning, guys. Thanks a lot for taking my questions.
Mark J. Enyedy — President and Chief Executive Officer
Good morning, John.
John Newman — Canaccord Genuity — Analyst
I just had two. So just wondering if you can give us a sense as to some of the types of data analyses that we might see from mirvetuximab at ESMO. Obviously, those data are embargoed, but just curious if you can talk about the types of analyses that we’ll see other than, obviously, the split between FR alpha high and medium and low.
And then the second question [Technical Issues] Anna. So previously you talked a little bit about some of the tweaks and changes that you can make to the second Phase III in ovarian cancer. And obviously you’re going to be meeting the agency. But just wondering if you could speak in general about what some of those things could be. Thanks.
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Sure, John. So the analyses that we’ll present at ESMO for the FORWARD I study will include the key primary and secondary endpoints that were protocol specified, and that will add color to the top line data that we’ve already reported. In addition, we’ve done some exploratory analyses to further understand the trial and the population, and those exploratory analyses that are informing the design of the next Phase III trial will be shared, as well.
Mark J. Enyedy — President and Chief Executive Officer
Maybe just remind them what the primary and key secondaries were.
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Yes. So the key primary endpoint for FORWARD I was progression-free survival by blinded independent review. And the key secondary endpoints included overall response rate and overall survival.
Mark J. Enyedy — President and Chief Executive Officer
The other question was around tweaks.
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Right. So the tweaks will be — based on the analyses that we’ve done on FORWARD I and the additional analyses, the exploratory ones, we will be designing, or we’re in the process of finalizing the design of the next Phase III trial. We anticipate that much of it will be the same in terms of platinum-resistant with 1 to 3 priors. Clearly, we will focus on FR alpha high patients, because that’s where we saw the strong consistent efficacy signal from the FORWARD I study.
John Newman — Canaccord Genuity — Analyst
Great. Thank you.
Operator
The next question comes from the line of Boris Peaker from Cowen. Please go ahead.
John Scott — Cowen and Company — Analyst
Good morning. This is John Scott on for Boris. Thank you taking our questions. First, previously you indicated you may monetize some lower-priority assets. So I wanted to know if there’s any update on that process?
And then, secondary, looking ahead, if mirvetuximab has a label that’s limited to the FR high population based on the new study. Do you anticipate the combinations that you’re pursuing would also be limited to FR high? Or do you anticipate maintaining a more broad strategy for all FR positive for those combinations? Thanks.
Mark J. Enyedy — President and Chief Executive Officer
Sure. In terms of business development you’ll appreciate that those kinds of conversations are not generally amenable to play-by-play. So it’s an active process with outreach to multiple parties, inbound interest. And we’re pursuing those conversations with all deliberate speed.
Right now we’re accruing patients in the combination studies with both medium and high levels of expression, and we’re continuing to evaluate those cohorts in terms of looking for one that will provide us with a clear path to the next label beyond a monotherapy label. And so what I would say is to be determined in terms of a registration path. But for the time being the cohorts that we have up and running include both high and medium patients, which are roughly 60% of the overall population.
John Scott — Cowen and Company — Analyst
Okay. Thanks very much for taking my question.
Mark J. Enyedy — President and Chief Executive Officer
Sure.
Operator
The next question comes from the line of Kennen MacKay from RBC Capital Markets.
Kennen MacKay — RBC Capital Markets — Analyst
Hi, good morning, and thanks for taking the question. I was wondering if maybe you could talk a little bit more about the potential costs of the addition of FORWARD — the next FORWARD Phase III trial and sort of what the levers are there in terms of the remaining moving parts in the trial design i.e., is there anything that could still move the needle on the estimates for the cost of this trial that hasn’t been sort of completely solidified yet? Thanks so much.
Mark J. Enyedy — President and Chief Executive Officer
Yes. Kennen, we have not previously, sort of, disclosed total trial cost, and you’ll appreciate that we’re in the process of working through an RFP with the various vendors, who might support that trial on a go-forward basis. And so with that as a backdrop I think that’s about what we would say. I mean, the expectations for this study, we will be adjusting the hazard ratio assumptions for this study from what we used in FORWARD I to reflect the data that we have, and that will have some impact on sizing. And then focusing exclusively on high patients. So those two things will factor into it. But at this point we’re just not in a position to comment on the cost.
Kennen MacKay — RBC Capital Markets — Analyst
Understood. Thanks for taking the question.
Operator
We’ll take the next question from Andy Hsieh from William Baird. Please go ahead, sir.
Andy Hsieh — William Baird — Analyst
Great, good morning. Thanks for taking my questions. I have two. So obviously, very intrigued about the MRD-positive AML population in the — I would assume, consolidation study. Would that — do you have an estimate in terms of duration?
And also in terms of EMA, just from a scenario analysis perspective, if they are willing to review the FORWARD I study how would that impact this ongoing effort in designing the new study?
Mark J. Enyedy — President and Chief Executive Officer
Sure. So I’ll let Anna — well, Anna, you can cover both of those topics.
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Sure. So we’re really excited about the MRD-positive cohort for IMGN632 monotherapy, because, as you know, patients who get intensive front-line therapy and then ostensibly do well, but still wind up having minimal residual disease that’s detectable by flow cytometry, for example, they don’t do very well. And so there is the potential for a well-tolerated monotherapy like ours to really benefit this population, and it would be a way for us to get a further signal of efficacy and understand the safety profile of our drug in less heavily pretreated patients than are currently being enrolled in our Phase I trial.
In terms of the EMA, we do plan to meet with the European regulators this fall for protocol assistance regarding the next Phase III trial for mirvetuximab.
Andy Hsieh — William Baird — Analyst
Okay. So in terms of timing, would that occur before or after ESMO?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
After.
Andy Hsieh — William Baird — Analyst
Okay. Got it. Well thank you very much.
Operator
The next question comes from the line of Debjit Chattopadhyay from HC Wainwright.
Aaron Welch — HC Wainwright — Analyst
Hey, guys. Good morning, thanks for taking our questions. This is Aaron Welch on for Debjit Chattopadhyay. So I just wanted to ask about ImmunoGen 632. Now that you indicate you’ve determined the recommended Phase II dose and, presumably, the dosing schedule, would you be able to disclose what that would be? Or could you talk about [Speech Overlap]
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Yeah. So right. So there are two schedules that we have explored, which is a Q3-week schedule and then a weekly schedule. And we look forward to sharing data from both schedules at ASH, should our abstract be accepted.
Aaron Welch — HC Wainwright — Analyst
Okay. Great. And for the next Phase III mirvetuximab study, would you be able to tell us — have you heard anything from physicians indicating strong interest? Again, I know there was a lot of interest in the first trial. So what have you heard?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Yes. Absolutely. We have really heard overwhelming enthusiasm and support for the next Phase III trial, because this is the only way that physicians will be able to get access to mirvetuximab for their patients. And platinum-resistant ovarian cancer has a high unmet need when you look at agents that are approved. And if you even look at the clinical trial landscape this is not where the PARPs show their greatest benefit, and there are not a lot of other drugs in the pipeline at this point that are being explored in platinum-resistant disease. So the enthusiasm is really high. Investigators want this drug for their patients, and they are looking forward to working with us, as we are with them, to execute quickly and well on the next Phase III trial.
Aaron Welch — HC Wainwright — Analyst
Alright. Great, looking forward to it. Thank you, guys.
Operator
We’ll take the next question from Jessica Fye from J.P. Morgan. Please go ahead.
Daniel Wolle — JP Morgan — Analyst
Hi, this is Daniel for Jessica. Thanks for taking our question. When we think about the next steps for 632, do you plan to conduct a randomized Phase III trial as an add-on to the [Indecipherable] or venetoclax? Or are these going to be single-arm studies?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Well, first things, first. We need to do a dose escalation study to basically demonstrate the safety of the combinations and the doses that are combinable. Venetoclax plus azacitidine is a very effective regimen. It’s not a walk in the park. There are some adverse events associated with it. So we will proceed as quickly as we can as thoughtfully as we can to identify the combination that we would then move forward. And certainly, a randomized trial would be involved in the development plan. It’s just too soon to say when the appropriate time would be.
Daniel Wolle — JP Morgan — Analyst
All right. If I can ask one more, it seems that the focus for 632, going forward, will be AML. Do you still intend to develop it for BPDCN, as well?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Absolutely. We have an ongoing monotherapy cohort in BPDCN, and we shared initial promising efficacy data from a very small number of patients at ASH last year. I’m glad to say that we have enrolled additional patients and we continue to see encouraging activity. And again, we look forward to sharing those data at ASH.
Daniel Wolle — JP Morgan — Analyst
Alright. Thank you very much.
Operator
We’ll now take a question from Biren Amin from Jefferies. Please go ahead.
Biren Amin — Jefferies — Analyst
Yeah. Hi, guys. Thanks for taking my questions. What are your plans, in the platinum-sensitive setting? I know you’ve looked at the mirv triplet combo. Could you share what your plans are, going forward, with that combo?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Sure. So based on the tolerability profile of mirvetuximab, we aim for it to be the combination partner of choice and to displace chemotherapy. Toward that end, in platinum-sensitive disease patients get platinum-based combination therapy. And therefore, the initial carboplatin doublet that we explored was quite favorable, which led us to aggressively explore the triplet of carboplatin, mirvetuximab and bevacizumab. And we look forward to sharing initial safety data and response rate data from that cohort at ESMO.
We really have two options then for further development for mirvetuximab, and that would be basically doublet therapy with carboplatin or a continued development with the triplet. And right now we’re really thinking through the options to figure out what makes the most sense for patients.
Biren Amin — Jefferies — Analyst
And then maybe in terms of the combination with the PARP, I know that trial is ongoing. When can we expect to hear from that study?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Yes. So you’re referring to the investigator-sponsored trial with Flora Bacchus and David O’Malley at Ohio State looking at rucaparib with mirvetuximab, and it’s cosponsored with Clovis. So it’s an IFP. It’s in their hands. It continues to enroll. And they will share data from it when they’re ready to.
Biren Amin — Jefferies — Analyst
Great. Thank you.
Operator
[Operator Instructions] We’ll take the next question from Jonathan Chang from SVB Leerink. Please go ahead, sir.
Jonathan Chang — SVB Leerink — Analyst
Hey guys, thanks for taking my questions. First question, can you give us a sense of how mature the FORWARD I data will be at ESMO?
Anna Berkenblit — Senior Vice President and Chief Medical Officer
At ESMO you will see data from the final progression-free survival analysis, which was our pre-specified protocol-based analysis. You will also see updated overall survival data. You may recall that the median overall survival for patients with platinum-resistant ovarian cancer is somewhere between the 11 and 14-month range. And so based on us having finished up enrollment first quarter last year, that gives you a sense of how mature the data will be from an overall survival perspective.
Jonathan Chang — SVB Leerink — Analyst
Got it. Thanks. And just second question, is the IND filing for IMGC936 still on track for the second half of the year?
Mark J. Enyedy — President and Chief Executive Officer
So in conjunction with the restructuring, we are in the process of transferring the lion’s share of the operational responsibility for the IND to MacroGenics. And I spoke with Scott last night just to talk through, and at this point our guidance is that the IND will go in, in the first half of 2020 to account for the need to transition a fair amount of this work and get, in particular, their clinical team up to speed and in the position to support the IND in the way that we would like.
Jonathan Chang — SVB Leerink — Analyst
Got it. Thank you very much.
Mark J. Enyedy — President and Chief Executive Officer
Sure.
Operator
Our last question comes from the line of Michael Schmidt from Guggenhiem Partners. Please go ahead.
Michael Schmidt — Guggenhiem Partners — Analyst
Hey, guys, thanks for taking my questions. I just had a couple on 632. Maybe if you could give us a sense of how many patients at the potential ASH update will have been treated at the recommended Phase II dose.
I had a question just regarding your level of confidence in actually having identified a good Phase II dose. I think at the ASH presentation last year you’ve seen activity at various doses, including very low doses. So I’m just curious your confidence level in having identified the right dose.
And then the last question on 632 was if you could just touch on how you think about potential areas of differentiation from some of the bispecific antibodies that are going out for the same target. Thank you.
Anna Berkenblit — Senior Vice President and Chief Medical Officer
Sure. So you may recall that when we presented data at ASH last year we had already explored several dose levels and we saw activity across the dose levels. We now have additional data across multiple dose levels that give us confidence in the recommended Phase II dose. We think there will probably be around 20 patients worth of data where you can see not just safety, but efficacy at ASH for that.
Moving to differentiation with the bispecifics, our drug is relatively short infusion that can be given as an outpatient once every three weeks, assuming the patient is well enough. It does not have the risk of the cytokine release type of things that you can see with the bispecifics. So potentially a better safety profile. There’s no head-to-head data comparing that, but looking at our safety profile we feel that it’s quite well tolerated, again over a range of doses, and has a convenience factor that patients could wind up appreciating very much.
Michael Schmidt — Guggenhiem Partners — Analyst
Okay. And then maybe just one follow-up. I guess can you remind us just to what degree is Jazz involved in the sort of earlier-development phases? And is there an opportunity to combine those maybe with Vyxeos?
Mark J. Enyedy — President and Chief Executive Officer
So this is a highly collaborative relationship. So we have formal contract committees that meet on a quarterly basis, but the teams engage on a much more regular basis. So our lead physician here at ImmunoGen came out of MD Anderson, and you probably know Stefan Faderl, who is on their side. So the two of them were colleagues at MD Anderson and speak regularly.
And so it’s highly collaborative. So as we move this program forward it’s in lockstep with them. ImmunoGen does control the development just from a contractual standpoint, but again, it’s a collaborative approach. And there is the potential to combine with Vyxeos, and we’re sorting through the specific indication where we would I think maximize the benefit of those two agents together. But that’s an active conversation.
Michael Schmidt — Guggenhiem Partners — Analyst
Alright, great. Thanks for the update.
Mark J. Enyedy — President and Chief Executive Officer
Sure.
Operator
It appears there are no further questions at this time. I’d now like to turn the call back to Mark Enyedy for any additional or closing remarks.
Mark J. Enyedy — President and Chief Executive Officer
Thank you. So very much appreciate everyone joining us on a summer Friday morning, and we will look forward to seeing you all at ESMO at the end of September. Thanks.
Operator
[Operator Closing Remarks]