Home Gold & Precious Metals Immunomedics’ (IMMU) Q4 2017 Results – Earnings Call Transcript

Immunomedics’ (IMMU) Q4 2017 Results – Earnings Call Transcript

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Immunomedics, Inc. (NASDAQ:IMMU)

Q4 2017 Earnings Conference Call

August 16, 2017 17:00 ET

Executives

Behzad Aghazadeh – Chairman

Michael Garone – Principal Executive Officer and Chief Financial Officer

Analysts

Jim Birchenough – Wells Fargo

Phil Nadeau – Cowen and Company

Matthew Andrews – Jefferies

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to Immunomedics Inc. Fourth Quarter and Fiscal Year 2017 Results Conference Call. As a reminder, this call is being recorded. Today is Wednesday, August 16, 2017.

Before we begin, I would like to remind everyone that during this call the company will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties. Actual results could differ materially from those expressed or implied on this call. For factors that could cause such differences, please refer to the company’s regulatory filings with the Securities and Exchange Commission most recently its annual report for the year ended June 30, 2017. The earnings report is available on the company’s website at www.immunomedics.com.

With us on the call today are Dr. Behzad Aghazadeh, Chairman of the Board of Directors of Immunomedics and Michael Garone, Principal Executive Officer and Chief Financial Officer of the company. Following their prepared remarks today, we will open the call up for questions.

At this time, I would like to turn the conference over to Dr. Aghazadeh.

Behzad Aghazadeh

Thank you. Good afternoon, everyone and thank you for joining us. We believe we have made significant progress this quarter across the number of key initiatives that will set us to bring 132, our breakthrough therapy candidate for the treatment of late stage triple-negative breast cancer to market in 2018. Since we last spoke, we have executed number of operational changes to capitalize fully on the tremendous potential that exists within the company. We believe that we have transformed Immunomedics and we are now executing highly effectively. Notably, we remain confident in our approval pathway for IMMU-132 in metastatic triple-negative breast cancer and are on track to submit a BLA to the FDA for accelerated approval sometime between the end of December 2017 and March 2018.

Beyond the utility in triple-negative breast cancer, we have multiple indications that we are actively exploring as well. As we look at our pipeline and business development opportunities, we are very excited about what the future holds for Immunomedics, the patience and we hope to help – that we hope to help and the potential for meaningful value creation. In a few moments, I am going to walk through some of the updates on this past quarter in more detail.

But first, I will turn it over to Mike who will go through some of the financial highlights.

Michael Garone

Thank you, Behzad. I am going to start with an update on our liquidity position. Cash, cash equivalents and marketable securities were $154.9 million as of June 30, 2017. That includes $125 million in gross proceeds raised in the private placement with institutional investors that closed on May 10. Additionally, at a Special Meeting of Stockholders held in June, stockholders approved an increase in the number of authorized shares of our capital stock from 165 million shares to 260 million shares. We are pleased with the significant operational progress we are making and believe that our current financial resources are sufficient to support operations through September 2018. That cash runway doesn’t include any potential cash receipts from our warrants outstanding with Seattle Genetics or other investors as our stock price has been trading above the warrants exercised price and these warrants expire during 2017 and 2018 respectively.

Now, for the results. Total revenue for the fourth quarter ended June 30, 2017 was $600,000 that compares to $900,000 for the same quarter last year, a decrease of approximately 33%. Total revenue for the full fiscal year was $3.1 million compared to $3.2 million for the fiscal year 2016, a decrease of approximately 3%. The decreases for both the fourth quarter and the full year periods were due primarily to a decrease in grant revenue. The decrease in full revenue was offset partially by a $100,000 increase in LeukoScan sales.

Total operating expenses for the fourth quarter ended June 30, 2017 were $27.4 million compared to $15.6 million for the same quarter last year, an increase of approximately 76%. Total cost and expenses were $82.2 million for the fiscal year, an increase of approximately 32% compared to the same period in 2016. The increases for both the fourth quarter and full year periods were due primarily to non-recurring general and administrative expenses including legal and advisory fees associated with the proxy contest launched by venBio in November 2016. The reimbursement of proxy related costs incurred by venBio and incremental executive severance.

Research and development expenses were $51.8 million for the full year, a decrease of approximately 3% compared to fiscal 2016 due primarily to an $11.4 million reduction in clinical trial costs resulting from the closure of the Phase 3 PANCRIT-1 clinical trial in 2016, offset by a $9.7 million increase in product development expenses for IMMU-132 manufacturing. We have recognized $25.5 million and $61.1 million in non-cash expense during the fourth quarter and full year ended June 30 respectively arising from the increase in fair value of warrant liability resulting from the increase in share price of our common stock during both periods. We also recognized the $7.6 million non-cash warrant related expense for the fiscal year representing the excess of fair value of the warrant issued to Seattle Genetics on February 10, 2017 over the proceeds received for the issue of the common stock and the Seattle Genetics warrant. There was no warrant related expense in 2016.

We did not realize any income tax benefit from the fiscal year because we had reached the maximum amount permissible under the New Jersey business tax certificate transfer program. This compared to a $5.1 million income tax benefit for fiscal 2016 from the sale of a portion of the New Jersey State net operating losses and research and development tax credits. Net loss attributable to stockholders was $53.3 million or approximately $0.48 per share for the fourth quarter ended June 30 and $153.2 million or approximately $1.47 per share for the full year. This compares to net loss attributable to stockholders of $15.9 million or approximately $0.17 per share for the fourth quarter ended June 30, 2016 and $59 million or approximately $0.62 per share for the full year 2016.

As of June 30, 2017, there were approximately 110 million shares outstanding and approximately 80% of our common stock is owned by institutions. On a fully diluted basis, there are approximately 186 million shares and that summarizes our financial results for the fourth quarter and for the 2017 fiscal year.

Now I will turn the call back over to Behzad.

Behzad Aghazadeh

Thanks Mike. As we have implemented a number of changes, the company aims at successfully submitting BLA to be FDA. There are three areas that we are acutely focused on. First, we have to prepare our complete data package for the submission. Second, the Phase 3 confirmatory trial in triple negative breast cancer has to be underway at the time of our filing. And third, we have to validate the CMC processes that we will use to scale up and commercial product.

First and foremost the FDA wants to see the efficacy data from approximately 100 patients with metastatic triple negative breast cancer from our single arm Phase 2 study with IMMU-132. The patient population is defined as those with relapse or refractory metastatic triple negative breast cancer that received at least two prior therapies for metastatic disease one of which has to be a taxane. We completed enrolling the necessary number of patients in December 2016 and the last patient received the first dose in early February. In terms of efficacy, the FDA has indicated they want to confirm overall response rate as assessed by blinded independent central review and the mature duration of response from the single arm Phase 2 study.

In January we reported a confirmed ORR of 29% in 85 patients based on local assessment and we look forward to providing the final Phase 2 results later this year. To put these results in perspective, current standards of care reported single digit to teens response rate and duration in the low single-digit months. As such we are very encouraged by our results. We are now in the process of compiling the full data including adjudication of all responses by central review before database lock. The second task is to have the Phase 3 confirmative trial in metastatic triple negative breast cancer underway at the time of the BLA submission. Preparation for the opening of this trial is proceeding according to plan. We recently executed the agreement and finalized the protocols with our CRO, the team’s preparations for patient enrollment are underway with an expected first patient treated to occur in early Q4 of this calendar year. We believe this enrollment timeline will satisfy FDA’s requirement for our filing of the BLA for accelerated approval. Our goal is to enroll as many patients in the U.S. as possible before activating European sites following FDA approval and as such have initiated site selection also in that confidence. Notably, the response has been universally enthusiastic from all the clinical trial sites that we have approached a testament we believe to the high unmet medical need and promise of our clinical data.

Moving on to CMC process validation, the third task. As with all approved products, the FDA requires commercial manufacturing processes to be validated before approval. We are not exempt from that requirement. However, with breakthrough determination – sorry, the breakthrough designation, we continue to work with the FDA to determine the level of validation required to be completed at the time the BLA is submitted with final validation work completed before the approval. We expect to receive clarification during a pre-BLA meeting with the FDA on the level of validation required at the time of the BLA submission, so we believe that our communicated filing window of end of 2017 through March 2018 will accommodate possible scenarios we foresee.

With our confidence in our regulatory strategy and substantially all work streams up and running for the U.S. BLA we recently started to broaden our focus to other key activities. As such, we have recently started taking the necessary steps to define our registration strategy in the EU. We are engaging with clinical sites to prioritize the next set of studies for our IMMU-132 beyond triple-negative breast cancer. And we have selectively reopened our data rooms on the heels of continued outreach from potential partners from regions of the world that we have stated we are not interested in pursuing independently. We look forward to providing updates on each of these activities in future venues.

Finally, I want to provide a quick update on the CEO search before we open the call up for Q&A. Our search is ongoing for a leader who will build out the company and position it for success beyond the BLA filing period. Ideally, the successful candidate will have the ability to oversee the evolution of Immunomedics to a fully integrated biotech company with strong partnerships and becoming a world renowned leader in the ADC space. We are being selective in this process. We believe this is a unique opportunity and we have interest in very impressive candidates. That said, we are going to be diligent and prudent and are not going to put expediency as of ensuring that we select the best possible individual for the job.

In the meantime, Mike, the team at Immunomedics augmented with our board appointed world class experts in manufacturing, clinical and regulatory strategy are doing an excellent job moving us forward. The board is also taking a very hands-on approach to ensure that no effort is untapped as we navigate through this critical phase of the company. One other leadership update, Usama Malik has recently been appointed to our management team in the role of Chief Business Officer. Usama has been supporting the organization as the board appointed consultant for the past several months overseeing all the critical work streams in preparation of our BLA filing. In his capacity as CBO, Usama will continue to focus on the execution of IMMU-132, a metastatic triple-negative breast cancer program, while also supporting the organization and evolution towards the commercial stage biotech company. Usama has worked as a senior executive with healthcare for nearly two decades with a focus on growth strategy designing, building and launching new business models and leading large scale transformational changes. He recently ran his own private consulting practice, advising boards and CEOs of healthcare companies and has previous served as a senior executive at Bridgewater Associates, Pfizer and Booz & Company. We are thrilled to have him on board. So as we can see, we have made tremendous progress taking the appropriate steps to bring IMMU-132 to market. We are confident that our success with IMMU-132 as well as our very strong pipeline of business development opportunities will generate meaningful shareholder value in the long-term.

With that operator, please open the call for questions. Thank you.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Jim Birchenough with Wells Fargo.

Jim Birchenough

Yes, hi, guys. Thanks for taking questions and congratulations on all the progress. Behzad, just on the pre-BLA meeting, have you made the request for that meeting yet and is there a prescribed timeline for FDA to get back to on that? And just on CMC validation, when you talk about different levels of validation, does the March 2018 timeline contemplates full validation and what would that involve? Thanks.

Behzad Aghazadeh

So more or less, yes, on both questions, the pre-BLA meeting actually they are going to be multiple touch points with the FDA, around CMC and fundamentally the pre-BLA package in its entirety and both have been we have reached out and there are set timelines for them to get back to us. On the second question, the backend of that window essentially contemplates full validation prior to submission.

Jim Birchenough

And just to follow-up is does validation require an inspection of each of the three contract manufacturers who are using or would that be something that would be more of a pre-approval type event?

Behzad Aghazadeh

Yes. So on the pre-approval inspection that’s separate to the actual validation. That will certainly have to occur and that will have to occur at Immunomedics and that’s a separate work stream that we are working on in preparation of that, typically within the first several months of the BLA filing unfolds. Whether the FDA chooses to do a similar inspection of the other facilities is a decision they would have to make, but both facilities are manufacturers. In one instance I think they own the lion share of all ADC manufacturing globally and so are essentially if you are willing presumably good standing or under constant review and so they may not receive or I assume most likely will not have a pre-approval inspection specific for this program. Anything else to add Mike?

Michael Garone

That’s right. It’s most likely that they will not require an inspection for those reasons.

Jim Birchenough

And just a final question just on the Phase 3 that’s proposed, could you maybe give us some broad strokes of size of the study, how many sites that sort of thing?

Behzad Aghazadeh

Yes. I don’t think we have publicly…

Michael Garone

We have guided to more than the 328 patients.

Behzad Aghazadeh

In terms of number of sites, I don’t have the number readily available to me. I was pretty involved in actually meeting a number of the sites both in the U.S. and Europe and we can certainly get back to you. But it’s a meaningful number and one that we actually increased versus the very original proposal.

Jim Birchenough

Well, thanks for taking all the questions guys.

Behzad Aghazadeh

Thank you.

Michael Garone

Thank you.

Operator

Our next question comes from Phil Nadeau with Cowen and Company.

Phil Nadeau

Good afternoon. Thanks for taking my questions. Also let me add my congratulations on all the progress. Just a couple of follow-ons to Tim’s questions, first on the pre-BLA meeting with the FDA, which you will get clarity on what’s required in the CMC package for filing, I think in the past you have suggested that that meeting would happen either late Q3 or early Q4, is that still the proximate timing of that meeting?

Behzad Aghazadeh

It is, what I would add though is that some of the questions may even be answered separate to the specific venue and earlier, but stay tuned and we will if there is anything materially we will certainly update. But some of the key questions might – because of the breakthrough designation Phil well, I think I have indicated in conversations in the past well, we are trying to go about it as formal as the FDA usually handles it. There has been a level of flexibility to get some key questions out of the way and so we are always in parallel process in trying to source that as quick as possible. But we certainly expect if not sooner than to have asset definitive meeting to give you all the answers that we require to really zero in on when we think we can file.

Phil Nadeau

Got it, okay. And on the difference between the timing – were you to file on December and were you to file on March, what is the difference between the process validation necessary in December versus March, I guess what I am kind of wondering is what type of work would you have to do between December and March, what exactly validation would be worked out over that timeframe?

Behzad Aghazadeh

Yes. So the work would be identical, but just one point what we feel and what the FDA feel comfortable that we pull the trigger and submit whatever has been completed up until that point versus ultimately the FDA would like to see the entire body from an approval standpoint. And maybe I should clarify back to Jim’s point. I would think we had our manufacturing experts on the call they would say that validation is an ongoing process because anytime you continue to scale up and we certainly anticipate over the life of the products continue to ramp up production with which would it brings additional validation including when we transfer to a second and third-party CMO they would continue to have to validate. But as far as the BLA approval validation steps are required the total body of work is the same, it’s just a question of how much do we need to have at the time of filing and how much can we stop and submit subsequent to that very initial, if you will, hit the send button. But certainly, everything has to be in and the work that we are working towards is to complete everything that’s required ultimately for the approval, it’s just a question of when are we ready to submit whatever is available at that time and would the FDA be willing to essentially receive on their side whatever is available at a certain point in time with the rest coming subsequent to that. And if the FDA says, we are willing to take whatever you have day one, just get us whatever you have end of this year that’s what we will send them and if they say no, hold off and get us these other pieces and then it will be sometime between Q1 all the way through the end of the Q1 if FDA says get us sort of everything we need before you submit.

Phil Nadeau

And could you give us some idea maybe just in terms of what those pieces are there would be some hope between December and March, would it be just additional stability data or I guess being in the manufacturing obviously, I am not exactly sure what else would be validated over those subsequent 3 to 4 months?

Behzad Aghazadeh

Yes, it’s not necessarily stability, it’s actual validation sort of a series of steps in protocol actions that need to occur and just to be clear there are validation of the antibody, the drug linker, the toxin and the finished – fill/finish product, glycolyze etcetera. We believe we will be in a position to have completed substantially all the work required on the antibody front. On the contents of that window we gave you. So, we will be done with the antibody validation hopefully by the end of this year. That’s the current plan and we are well on track. Equally, the fill/finish end products, the conjugation and the fill/finish glycolization steps equally are not rate limiting and should be completed before the end of this year. It’s that toxin linker, that middle piece, where depending on the level of validation and again that’s a series of if you will documentations and again it’s good that you are asking manufacturing question from a non-manufacturing guy. It’s a series of protocol, documentation etcetera, that need to occur and it’s principally around that middle component that is rate-limiting and that’s what we are working towards completing as rapidly as possible, but that work will not be completed before the end of this year, it will take us before until the end of the first quarter or thereabouts. And so the FDA – the question of the FDA is are you willing to accept our work – the end product validation work and leave that one out or would you like to see some of that or all of that and that’s going to determine the timeout.

Phil Nadeau

Got it, okay. That’s very helpful. And then just last question you mentioned in the prepared remarks if there were some non-recurring items in the SG&A expense line this quarter, can you give us some sense of the magnitude of those expenses and therefore what is the SG&A expense run-rate as you enter fiscal 2018?

Michael Garone

About $20 million is non-recurring SG&A and it will be off to get back people on the run-rate besides that. I think it’s about $20 million as well, but I will get back to you into details and that’s in the K naturally and that was all in connection with executive severance reimbursement of venBio proxy costs and all the legal and other administrative fees in connection with the proxy applied.

Phil Nadeau

Okay, that’s very helpful. Thanks for taking my questions and congratulations again on the progress.

Behzad Aghazadeh

Thank you. And I did get an answer we are about 80 to 100 sites for the Phase 3, but Jim, if you are still on, you can follow-up. Operator?

Operator

[Operator Instructions] Our next question comes from the line of Matthew Andrews with Jefferies.

Matthew Andrews

Hey, good afternoon, Behzad and Michael. What are the plans relative to meeting with the EMA to was that the protocol has it been vetted and approved by the CHMP and I am referring to the Phase 3 study you are going to kickoff in Q4?

Behzad Aghazadeh

So as I indicated in my prepared remarks, we are actually taking the steps to explore with the FDA potential path to approval, obviously a randomized study as we proposed in Phase 3 is setup on a certain timeline, but we are exploring whether there is an alternate path to approval perhaps akin to the U.S. accelerator path and we will update you once those series of meetings that we have taken steps to have those conversations when they occur and when there is an update to provide, we will certainly communicate that. But based on our current understanding and Mike I don’t know if you have anything to add, but I believe the Phase 3 as it designs would be considered registration for the EMA, but I think that would also have to be confirmed.

Michael Garone

Yes. We need to confirm that, okay.

Matthew Andrews

Okay. Thank you. You have a potential best in class profile on urothelial cancer, so what are your general thoughts relative to initiating some sort of pivotal study in that indication?

Behzad Aghazadeh

Yes. So that’s exactly sort of the second bullet that we refer to sort of the next steps. We are – we have been squarely focused on getting the BLA and all the works up and running. And as of quite recently have we – are we in a position to really divert our focus at least at the leadership level to those next steps. So EMA strategy is one of the areas we have started to break ground. And then the second one is the next set of the trails, so stay tuned urothelial certainly we look forward to providing an update here at ESMO. And on the heels of that we are exploring whether that’s the next indication and if it is, what’s the best strategy last line versus potential combo. And then finally whether it’s just urothelial or other indications that we have recently had some publications and others that we haven’t broadly discussed yet, so stay tuned. But there is a near-term set of activities on our end that’s focused on what the next indications are and we will certainly provide the update as soon as feasible.

Matthew Andrews

And then you talked about some other activities relative to the agency outside of CMC, presumably that would include discussion around preclinical and the clinical package as part of the pre-BLA meeting, is that right?

Behzad Aghazadeh

You are right. The pre-BLA meetings will be all encompassing. And that’s the work that we have done. We did that work sort of very early on in terms of establishing whether we are in good shape with what we have and we always felt we had a pretty solid package already. They are not compiled but readily compliable in timeframe, but certainly all of those will be part of the BLA conversation, pre-BLA meeting.

Matthew Andrews

And then ahead of that presumably you would have to share the put together a dossier or share those data with the agency and allow them sufficient time to look at the Phase 2 data, is that correct?

Behzad Aghazadeh

That is correct.

Matthew Andrews

And then – I was just going to ask, generally how long do they need to review those data before you have them, is it a month or two months?

Behzad Aghazadeh

To be honest I am not sure if I know the answer, what those general rules are. But what I would tell you is that there is an ongoing dialogue and elements of what is going to be discussed has been discussed in past, but certainly there is going to be a comprehensive discussion at the pre-BLA meeting. And there is a doc here that includes all the information. But what I would say is that not everything that we send to the FDA is going to be the first time they would see it.

Matthew Andrews

Got it.

Behzad Aghazadeh

And perhaps maybe if I could a little more color to that. As we are moving on a bit of expedited timeline with the agency and they have been very accommodating. Part of their objective is always to ensure that this is worthwhile to them, if you will. And as a result they might come to us along the way and say please submit this kind of information. We don’t necessarily always know the basis for their request. But I think it’s just part of their requirements or if you will their internal check list to ensure that their speed at which they are moving is worthy if you will of the data and so far it was very, very rapid turnaround with any questions that we have asked or anything that they required. So we feel pretty good about that dialogue.

Matthew Andrews

Okay, great. Thanks for the added color. Good luck the rest of the year.

Behzad Aghazadeh

Thanks very much.

Operator

We have a follow-up question from the line of Jim Birchenough with Wells Fargo.

Jim Birchenough

Hi guys. Just thinking about the timing of initiating the pivotal study, if it turns out that FDA gives you feedback that says they would like to see full validation data including the middle part and it’s taking you to March, is there some risk to starting the pivotal in early fourth quarter or is that something you would just consider dotting i’s and crossing t’s and it’s the low risk endeavor to start the pivotal at that time or would you consider pushing out the initiation of the pivotal until you have got greater clarity on that middle part that FDA is asking for?

Behzad Aghazadeh

They are very entirely independent and the validation is not at all – there is nothing rate-limiting process for us to start the Phase 3. Our material has been sanctioned, if you will, by the FDA, is ready to go and what’s between us and first patient treated is opening the sites and that just takes quite some time it turns out with the CRO, but nothing keeping and rate-limiting, we would start our Phase 3 as soon as possible. And frankly it just allows us to enroll more patients in the U.S. because the window would go that much further before an approval, which we believe is probably unlikely for us to substantially enroll numbers beyond the approval window. And that’s why the time might give us more patients in the U.S. Yes, the only thing I would say is it’s kind of why we have also gone with it in larger number of sites in order to make sure we get a good number of patients in the U.S.

Jim Birchenough

And just a follow-up on potential business development activities in partnering in non-critical territories for Immunomedics, is that something you anticipate finalizing this year or is that more 2018 initiative?

Behzad Aghazadeh

Really hard to predict timing. Again as part of our focus on the BLA, we only very recently started opening it up selectively to parties that have expressed interest. We met a number of parties at ASCO and venues subsequently, but only just to keep them abreast of the developments, but not really opening up access our team for interacting and that’s happening now. So, how that plays out and what timeline is just impossible to predict.

Jim Birchenough

Okay, great. Thanks for taking the follow-ups.

Behzad Aghazadeh

Certainly. Thank you.

Operator

I am not showing any further questions. At this time, I would like to hand the conference back over to Michael Garone for his closing remarks.

Michael Garone

Thank you, Lisa. And we would like to thank all of you very much for joining us this afternoon. On behalf of the entire management team, I would also like to thank you for your continued support and interest in Immunomedics. Thanks, again.

Operator

That does conclude today’s conference call. You may now disconnect. Thank you and have a great day.

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