ImmunoGen, Inc.
Q4 2016 Earnings Call Transcript

Published: 4 Aug 2016

[Operator:]

Good day and welcome everyone to the ImmunoGen Fourth Quarter Fiscal Year 2016 Financial Results Conference Call. Today’s call is being recorded. At this time for opening remarks and introductions, I would like to turn the call over to the Executive Director, Investor Relations and Corporate Communications, Carol Hausner. Please go ahead.

[Carol Hausner:]

Thank you. Good morning and welcome to our first quarterly call with our new President and CEO, Mark Enyedy. This call has accompanying slides that can be downloaded from the Investors section of our website, immunogen.com. Also, earlier today we issued a press release that includes the summary of our recent progress and our financial results for the quarter and fiscal year ended June 30, 2016 which is also on our website. During today’s call, we will be making forward-looking statements. 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, which also can be accessed through our website. Mark will provide an update on ImmunoGen’s strategy; our Chief Development Officer, Dr. Charlie Morris, will discuss our pipeline, and our Chief Financial Officer, Dave Johnston will discuss our financial results and guidance. We’ll then open the call to questions. Mark?

[Mark Enyedy:]

Thanks, Carol and good morning. I joined ImmunoGen in mid-May and I’m excited to be here this morning to review with you the significant progress we’ve made with the business over the last 90 days. Before covering our activities for the quarter, I thought I’d start the presentation today by highlighting what attracted me to ImmunoGen and why I see this company positioned for sustainable value creation. Moving to slide 5, smart [ph] technology is a knowledge-based sector, success in our business begins with great people. To that end I’ve inherited a strong team at ImmunoGen both home-grown and drawn from premier companies across the industry with deep experience and developing, manufacturing and commercializing oncology therapies. That team has established a leadership position in ADCs which are an increasingly important approach to cancer therapy with a number of agents and development more than doubling over the last five years. To this growing field, ImmunoGen brings a robust portfolio of four clinical candidates and continued innovation with ADC technologies. Our portfolio is led by mirvetuximab soravtansine, a first-in-class, folate receptor alpha targeting ADC entering Phase 3 testing for platinum-resistant ovarian cancer, a patient population with limited therapeutic options. Behind mirvetuximab, we feel the productive platform that continues to generate differentiated ADCs including 779 for AML which integrates our IGN payload and 529 for DLBCL which has generated striking preclinical data and is now in a Phase 2 trial in combination with Rituxan. Levering this platform, we’ve entered into a number of high-value partnerships with leading companies such as Roche, Bayer, Amgen and Takeda. Collectively our partners are developing nine clinical candidates that deploy our technology. Finally, to support these activities, we strengthened our balance sheet significantly last quarter and started the current fiscal year with almost $250 million in cash. So I am excited to be at ImmunoGen. With a combination of talented people, robust portfolio and a strong cash balance, this company is well-positioned for sustainable value creation for our patients, employees and shareholders. Moving to slide 6, realizing on the promise of this business requires clear strategic direction and priorities. Our goal is to build a fully integrated biotech company that delivers innovative ADC therapies to cancer patients around the globe. To attain this goal, we are focused on four strategic priorities. Number one

[Charlie Morris:]

Thank you, Mark and good morning everybody. Moving to slide 11, as you’ve heard the executing on the speed-to-market strategy for our lead program mirvetuximab soravtansine is a top strategic priority for ImmunoGen. Mirvetuximab soravtansine is a highly differentiated agent in-development for prevalent cancer with limited treatment options today and its Phase 3 ready as you’ll see on slide 12. FORWARD 1 reflects the fastest potential approval of mirvetuximab soravtansine is as a single-agent therapy and we’re advancing Phase 3 based on the sizeable safety database that supports its advancement, demonstrated clinically meaningful single-agent activity which supports its moving into a controlled randomized trial that can access whether its activity is better than the single-agent therapies available today and the appropriate patient populations having being defined. At ASCO, we presented findings from the perspective assessment of mirvetuximab soravtansine for the treatment of folate receptor alpha positive platinum-resistant ovarian cancer. The agent demonstrates meaningful single-agent activity in the full 46-patient cohort with a 26% confirmed response rate and medium progression free survival of 4.8 months. Standard single-agent therapy today usually has response rate below 20% and progression-free survival below 4 months. While the study investigated and at ImmunoGen we’re very happy with these findings, the patient population for Phase 3 trials should be most highly defined than what was used in the signal finding assessment. The inclusion criteria allowed enrollment of patients for platinum-resistant disease, folate receptor alpha positivity with low, medium or high folate receptor alpha expression. As significant and possible more significant, patients have received a wide range of numbers of prior regimens, anywhere between one and five. Half of the patients enrolled have to perceive three or fewer and half of them received four or five. The low leads of lead data enabled us to further define specific patient population for the Phase 3 trial. Patients who had received up to three prior regimens were more likely to respond in the group overall, and those who additionally had at least medium FR alpha positivity have been greatest likeliness of responding. Based on patient screening and published data, we estimate approximately 60% of patients with ovarian cancer have at least FR alpha, a medium FR alpha expression with 40% having high expression. This finding benefits us in terms of problems. Studying mirvetuximab soravtansine in this earlier line intercepting in the Phase 3 trial expands the relevant population to around 5,000 to 7,000 patients per year in the U.S. with a comparable number in Europe. We recently shared all of this information with the FDA, the safety data, the demonstrative activity and our planned Phase 3 trial including the selected patient population. This was a positive meeting and with the benefit of feedback from the FDA, we are moving forward to initiate the Phase 3 trial as planned before year-end. Moving to slide 13, as a reminder FORWARD 1 will be a randomized controlled Phase 3 trial and with 333 patients will be randomized 2

[Dave Johnston:]

Thanks, Charlie. Our financials are shown on slide 18, and were discussed in some detail on our press release issued this morning. So with that I’m going to review the highlights and then review our guidance through December 31. Effectively January 1, we’re going to be changing our reporting period from a fiscal year ending June 30 to the calendar year which ends obviously December 31. And we’re doing this to bring our reporting calendar into line with the vast majority of biotech companies. So with that, onto a summary of our financial results. Revenues for the fiscal year 2016 were $60 million, and of this revenues from license and milestone fees were $27 million in fiscal 2016 made up of $9 million of amortization of previously received upfront fees and $18 million of revenues from partner milestone payments. Revenues in the fiscal year also included $25 million of non-cash royalty revenue on sales of Kadcyla. As a reminder, the royalty is passed to the purchaser of the royalty stream and we report non-cash Kadcyla growth revenue that is partially offset by non-cash interest expense. Operating expenses in 2016 were $184 million and this consisted of $147 million of R&D expenses and $37 million of G&A expenses. For the fourth quarter of the fiscal year 2016, ImmunoGen reported net loss of $45 million or $0.51 a share. And for the full fiscal year, ImmunoGen reported a net loss of $144 million or $1.65 per share. In fiscal 2016, cash used on operations was $125 million and capital expenses were about $10 million. We ended the fiscal year with approximately $245 million of cash and cash equivalents and $100 million of convertible debt outstanding, reflecting our financing transaction which we completed in June that provided us with net proceeds of approximately $97 million. We’re going to be managing expenses to enable this cash balance to last for two years, covering a number of dying inflexion points as we advance our wholly-owned pipeline. We also provided guidance for the six-month period, the stub-period from July 1 to December 31 on our press release this morning. For reporting during this period, we will be filing a 10-Q quarterly report as normal for the quarter ending September 30, and the annual report 10-K(t) for the full transition period ending December 31. Then beginning the calendar year 2017, we will file 10-Ks and Qs on a calendar year basis and we will provide the guidance for calendar year 2017 shortly after the start of the year. So, turning to our guidance for July 1 to December 31, 2016 period, we project revenues to be between $40 million and $45 million, operating expenses to be between $95 million and $100 million, net loss to be between $55 million and $60 million, cash used in operations to be between $65 million and $70 million, and capital expenses to be between $2 million and $5 million. And we expect to end the six-month period with between $170 million to $175 million in cash. With our recent financing, we’re in a solid cash position which will enable us to execute on the strategy outlined by Mark. With financial discipline, we believe we’re sufficiently funded to advance our programs through several important value inflexion points. So, with that I’ll turn the call back over to Mark.

[Mark Enyedy:]

Thanks Dave. And as we execute on our strategy, we expect to achieve a number of important milestones over the next 12 to 18 months which are set out on slide 20. First and foremost, we’ll be enrolling our first patient in the FORWARD 1 Phase 3 trial with mirvetuximab before the end of the year. In our FORWARD 2 trial, we will be opening the cohort, assessing mirvetuximab with Keytruda this quarter and continuing to dose patients in the three other cohorts already open. We’re on track to begin reporting for on FORWARD 2 in the second quarter of 2017 with a steady flow of updates anticipated thereafter. We’re also submitting several abstracts to ASH with intriguing preclinical data on 779, 632 and 529 and we’ll be reporting the first 779 clinical data in 2017. Our partners are also making progress and we expect another partner program to enter registration studies this year. Turning to slide 21, and coming back to my comments at the start of the call, I’m excited to have joined ImmunoGen as we transition to a fully integrated oncology company. We are a leader in a growing field with cutting-edge technology, a rich pipeline of differentiated product candidates, a talented and experienced management team, strong partnerships and a number of upcoming milestones. With a clear set of priorities and the recent strengthening of our balance sheet, ImmunoGen is well positioned for sustainable value creation for our patients, employees and shareholders. And with that, I’ll turn the call over to Carol to open up for Q&A.

[Carol Hausner:]

Thanks Mark. We are about to open the call for questions. We ask that these be limited to one to two questions per person until everybody has had a chance to ask questions, at which point you can come back into the queue. Operator, we are now ready to open the line for questions.

[Operator:]

[Operator Instructions]. And we’ll take our first question from John Newman with Canaccord Genuity.

[Mark Enyedy:]

John?

[Carol Hausner:]

You’re on John. So, we’ll go to the next question.

[Operator:]

And we’ll take our next question from Simos Simeonidis with RBC Capital Markets.

[Simos Simeonidis:]

Good morning, thank you for taking the questions. Kind of a mechanism related question. The 6.7 months of PFS that you saw with the population you’re going to do the Phase 3, and is the same as the population with the low expressers and the response rate is also fairly similar. Can you help us understand that or tell us what do you think about that?

[Mark Enyedy:]

Charlie.

[Charlie Morris:]

I think when we think about the population scene, the number of patients in this data set with low expression is relatively small. And what we wanted to do was to really give ourselves the best shot at positivity for the overall study. So, clearly there is some activity in the low group. But whether it is truly the same as the medium and high expression, I think remains to be seen. So, what our view is that the medium and high expressers, you would certainly expect to bake some mechanism of action to have them, to be susceptible to the patient growth. And therefore let’s go ahead in those, because we can always do more work in the low population at a later time. But the highest probability of success has to be in the expressers based on mechanism of action, based on preclinical data. And we thought rather than increasing the risk in the trial by having all comers, we would really maintain the medium and high, and give ourselves the extra shot with the analysis of both the high and the medium populations.

[Simos Simeonidis:]

Okay, great. Then in terms of your meeting with FDA, you describe it as a positive meeting. Can you give us any highlights or talk about what they liked about the data, any concerns. I know the endpoint was described in your slides as significant improvement in PFS. And then you also say in high expressers only or in all patients. Can you talk about that point?

[Charlie Morris:]

Rather than speaking on behalf of the FDA and especially they have 30 days from the meeting to give their final minutes. Let me, I’ll talk about what the main points of the discussion were. We talked about the acceptability of progression-free survival as a primary endpoint for approval. They accepted that [indiscernible] that was an appropriate endpoint. We asked about the size of the safety database that we presented the time of submission of the BLA would be appropriate and they said that certainly the size of database if they’re unable to approve that as FDA would always say, they said it’s a review matter. And therefore they’ll consider that as a time. We asked about the statistical plan, they were accepting of our statistical proposal. And so, all of those key elements, the key design elements, the key things that we were focused on, the population that were defining were really the things that we wanted to discuss with them and get their feedback on. And they were accepting, with describing some detail of the design of the FORWARD 1 trial previously. And it’s going to proceed exactly as we had previously described. So, obviously we were very pleased with that outcome.

[Operator:]

And we’ll take our next question from Matthew Harrison with Morgan Stanley.

[Cyrus Amoozegar:]

Hi, yes, this is Cyrus on for Matt. So, for this FORWARD 1 study, when you met with the FDA, do you guys explore any response based end-points and was the FDA open to any of them? And then, also for FORWARD 1, can you give any guidance on basically how long it will take to enroll or any expectations you guys have?

[Charlie Morris:]

In terms of different endpoints, we feel that the perfect endpoint for full approval was going to be progression-free survival. And so we didn’t sort of lay alternatives out to the FDA, we explored with them whether this would indeed be an appropriate design for full approval. And they were accepting of that design. So we didn’t put that question onto the - of an alternative endpoint onto the table. And I’m sorry Cyrus…

[Cyrus Amoozegar:]

Timing of the data.

[Charlie Morris:]

I mean, what we have said is that we believe that it will take around three years to get, to have data from the study, we expect to have data in ‘19. So, obviously it takes a while to get up to full opening of the sites. But I think we’d be hopeful that we would have the patients recruited in, it’s sort of a hopefully 18 months or less timeframe.

[Cyrus Amoozegar:]

Great. Thank you.

[Operator:]

And we’ll take our next question from Jessica Fye with JPMorgan.

[Unidentified Analyst:]

Hi guys, this is Ryan on for Jess, I appreciate you taking her questions.

[Mark Enyedy:]

Sure.

[Unidentified Analyst:]

As we think about FORWARD 1, what are your thoughts on maybe the preferred physicians’ choice? And second how do you think about the variability for PFS in that control arm? Thanks.

[Charlie Morris:]

In terms of the physicians’ choice, my, and this is speculation obviously. But I think that will be a fairly even split of patients receiving Doxil or paclitaxel and just a small number of patients getting [indiscernible]. In terms of the variability, obviously patients who have had different numbers of lines of prior therapy, then maybe some differences between those two though that’s never been clearly established in randomized studies. It would infer from the [indiscernible] study there is some better outcome with things like paclitaxel. But we’re comfortable with the design and based on historic data that we will be competitive with all three of these, that’s how we set the trial, that’s how the FDA was comfortable with setting up the trial. So, the variability really comes out through the randomization within the study. And I think our objective here is to show that current standard single-agent choices hopefully are not as good as mirvetuximab. And therefore that’s the design of the study to show that.

[Unidentified Analyst:]

And is it reasonable to assume that the majority of them will be 2 plus lines of therapy i.e. that not, should it be probably will not be too many first line or patients with only one line of prior therapy?

[Mark Enyedy:]

I suspect that’s a reasonable assumption about two thirds of patients if not more are platinum-sensitive at their first platinum treatment. So the majority of patients will get a second round of platinum before they become platinum resistant. So, I think one prior line would be a minority but I think there will some in there.

[Unidentified Analyst:]

Great. Thank you.

[Operator:]

And our next question comes from Boris Peaker with Cowen & Company.

[Boris Peaker:]

Good morning.

[Mark Enyedy:]

Hi Boris.

[Boris Peaker:]

I’m just looking at the catalyst and I don’t see the endometrial study in the presentation. Is that still planned or is that no longer in the plan?

[Mark Enyedy:]

Obviously we’ve been completing the initial cohort in the Phase 1 in 20% those data next year. At this stage, based on results, we haven’t based on the strength of the signal that we have enough variance. And so that’s how we’ve really taken that as our key focus at this point. Endometrial is something that we’ll come back to but our operational priority right now is to get Forward 1 started.

[Boris Peaker:]

Got you. And speaking in terms of resources and operating expenses. So, your cash operating guidance for the second half of ‘16 is about $65 million to $70 million. And Mark noted in his opening remarks that you plan to invest more in your earlier stage pipeline. I’m just wondering can we extrapolate for the full fiscal 2017, which is going to be on a calendar basis and can we talk about maybe close to $150 million in cash operating expenses?

[Mark Enyedy:]

Certainly.

[Dave Johnston:]

Hi, Dave here. I wouldn’t necessarily do that because as Mark also said, we’re taking a real close look at the operations in general. And as he said, we’re going to be reporting on that the next couple of months. But the idea here is that, with the resources that we had in hand, the $245 million and sort of normal expected milestones and revenues from our partners, with all the things that we’re planning on doing, including investing in the earlier stage pipeline, we expect that that should last us for a solid two years, so that would put us at least until the middle of 2018.

[Operator:]

And our next question will come from Biren Amin with Jefferies.

[Biren Amin:]

Yes. Thank s for taking my questions. Just on the ongoing biopsy trial, when can we expect data from that side?

[Mark Enyedy:]

We didn’t really mention that. Some point next year. But we’ll be looking at whether the data is mature enough to put something in for ASCO sometime, we didn’t think there was quite enough in the data set at this time to get something in by the end of this year. So I think you’re probably looking at ASCO next year.

[Biren Amin:]

So, I mean, you’re clearly looking at that data set. Are you incorporating any of the key learnings from that data set into the FORWARD 1 Phase 3 trial?

[Mark Enyedy:]

I would say, I don’t think there is enough in there its 27 patients. So I think to start trying to infer so strongly that it would directly impact where we are with the study would probably be a bit of a gamble. But obviously we look at the efficacy information is probably is important, anything in there to ensure that we’re continuing to see the levels of activity consistent with where we are. And there is nothing that’s making us nervous about the design of the trial.

[Biren Amin:]

And then, with regards to FORWARD 1 how are you thinking about your start plan? Are you going to evaluate PFS and high expressers initially and then go to all patients, is this the step-wise plan?

[Mark Enyedy:]

No, it’s not a hieratical approach, so you’re able to test both populations without paying penalty.

[Biren Amin:]

Great. Thank you.

[Operator:]

And we’ll take our next question from Michael Schmidt with Leerink Partners.

[Michael Schmidt:]

Hi, thanks for taking my questions. You laid out some figures in terms of market size of patient numbers for folate receptor alpha, patients with medium or high expression. I was wondering if there is data looking at overlap with the BrCA population in ovarian cancer?

[Mark Enyedy:]

We don’t have detailed information at this point Michael. But it’s something that we are continuing to explore. And we will continue to look at these specimens that we obtain. When we think about patients with BrCA mutations they are often relatively platinum sensitive. So, they may get two or three rounds of platinum before becoming platinum resistant. So in our particular populations, I think you could speculate that there might not be a substantial overlap because having had a relatively small number of prior therapies I’m being platinum resistant is probably not the typical phenotype if you like for a BrCA mutated patient.

[Michael Schmidt:]

Okay, thanks. And then you mentioned the Bayer mesothelioma program. And I was just wondering if you can remind us of the economics there number one. And number two, if there is any information out there in terms of timing for that trial to complete?

[Carol Hausner:]

There isn’t, this is Carol. There isn’t any information out there in terms of timing. What has been disclosed is we get milestones potentially totaling $170 million and royalties are between 4% and 7%.

[Michael Schmidt:]

Okay, great. Thanks so much.

[Operator:]

And that concludes today’s question-and-answer session. I would like to turn it back over to Mark Enyedy for any additional or closing remarks.

[Mark Enyedy:]

Yes. Thank you all for joining us on the call today. And we’re quite pleased to report the progress that we’ve made in recent months and to layout our strategy to build a fully integrated oncology company delivering innovative ADCs. I look forward to continuing to update you on our progress. And thanks again for your time today.

[Operator:]

And that does conclude today’s conference. Thank you for your participation. You may now disconnect.