Exelixis' CEO Discusses Q3 2012 Results - Earnings Call Transcript

Exelixis, Inc. (NASDAQ:EXEL) Q3 2012 Results Earnings Call November 7, 2012 5:00 PM ET

Executives

Charles Butler - Vice President, IR and Corporate Communications
Mike Morrissey - President and CEO
Frank Karbe - Chief Financial Officer
Gisela Schwab - Chief Medical Officer

Analysts

Eric Schmidt - Cowen & Company
Karen Jay - JPMorgan
Joel Sendek - Stifel Nicolaus
Biren Amin - Jefferies
Ryan Martins - Lazard Capital Markets
Echo He - Maxim Group

Operator

Good day, ladies and gentlemen. And welcome to the Exelixis’ Third Quarter 2012 Financial Results and Business Update Conference Call. My name is Anne, and I will be your coordinator for today’s call. As a reminder, this conference is being recorded for replay purposes. At this time, all participants are in listen-only mode. (Operator Instructions)

We will be facilitating a question-and-answer session following the presentation. I would now like to turn the presentation over to your host for today’s call, Mr. Charles Butler, Vice President of Investor Relations and Corporate Communications. Please proceed, sir.

Charles Butler

Thank you for joining us for the Exelixis’ third quarter 2012 financial results call. Joining me on today’s call are Mike Morrissey, our President and CEO; Frank Karbe, our CFO; Gisela Schwab, our CMO. Who will together review our corporate, financial and development progress for the quarter ended September 30, 2012. They also will discuss priority activities for the remainder of the year and provide an update on cabozantinib, our lead clinical development program.

As a reminder, we are reporting our financial results on a GAAP basis only and as usual the complete press release with our financial results can be accessed through our website at exelixis.com.

During the course of this presentation, we will be making forward-looking statements regarding future events or the future performance of the company. Including statements about possible future developments regarding clinical, regulatory, commercial, financial and strategic matters, actual events or results of course could differ materially.

We refer you to the documents that Exelixis files from time-to-time with the Securities and Exchange Commission. Specifically, the company’s most recent Form 10-Q filed today November 7, 2012.

These documents contain and identify under the heading Risk Factors, important factors that could cause actual event to differ materially from those contained in any forward-looking statements, including risk related to the potential failure of cabozantinib and GDC-0973 formally XL518 that demonstrate safety and efficacy in clinical testing, Exelixis’ ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion, Exelixis’ dependent on the relationship with Genentech/Roche with respect to GDC-0973, the sufficiency of Exelixis’ capital and other resources, and the uncertainty of the FDA review and approval process.

With that, I’ll turn the call over to Mike.

Mike Morrissey

Okay. Thank you, Charles, and thanks to everyone joining us on the call today. We had another busy quarter in Q3 and expect the next few months to be one of the more memorable times in our corporate history.

We’ll cover usual topics today, including an overview of our Q3 financials, our cabozantinib development activities and review of data presented recently at ESMO. We’ll also briefly touch on the MEK inhibitor XL518, which I’ll refer to today as GDC-0973, which is being developed by Roche/Genentech.

We’re obviously extremely focused on both the cabo MTC NDA review and our commercial build-out pending potential approval. To head off any questions that might arise later, I’ll remind you now that we will remain silent on both topics today as to not preempt the review process or get ahead of things by talking about potential commercial activities pre-approval. We’re obviously prepared to address these issues in detail at the appropriate time.

Cabozantinib clinical development continues to advance across multiple indications, presentations at ESMO on cabozantinib in MTC, prostate cancer and non-small cell lung cancer clarity on both dose and therapeutic opportunities in these important tumor indications.

The COMET Phase 3 trials evaluating cabo in CRPC patients continues to advance and we’re actively engaged in evaluating the potential of cabo in earlier lines of therapy including two separate ongoing combination trials with abiraterone and docetaxel, as well as a trial to investigate the combination of cabo with enzalutamide which is currently in planning.

In addition to our broad CTEP and IST programs, we’re also exploring options for pivotal trials in additional indications, including an in-depth analysis of RCC and HCC pivotal trials. Gisela will provide additional data and color commentary on these activities shortly.

In addition to cabo, a second compound discovered and advanced to the clinic by Exelixis’ gained additional visibility at ESMO. Preliminary results from BRIM7 and ongoing Phase 1b trial of the BRAF inhibitor Vemurafenib in combination with the MEK inhibitor GDC-0973 in patients with locally advanced, unresectable or metastatic melanoma carrying a BRAFV600 mutation were reported by Roche and Genentech.

The Phase 1b dose escalation study was designed to evaluate the safety and tolerability of Vemurafenib in combination with GDC-0973. All 24 BRAF inhibitor naïve patients available for tumor responses had a decrease in tumor size from baseline and additional follow-up is required to determine the confirmed objective response rate. The full details can be found in our September 29th press release from ESMO at exelixis.com.

As disclosed in clinicaltrials.gov, GDC-0973 is moving forward into a Phase 3 pivotal trial in combination with Vemurafenib in treatment naïve melanoma patients carrying a BRAFV600 mutation.

We believe this is an important development for Exelixis as it places us among a small group of biotech companies that have two internally generated compounds in late stage clinical development.

It’s also important to us because we retain a significant economic interest in GDC-0973. Under the terms of our agreement with Genentech we are entitled to an initial equal share of U.S. profits and losses, which will decrease a sales increase and we’ll share equally in the U.S. marketing and commercialization costs.

The profits share has multiple tiers. We are entitled to 50% of profits from the first $200 million of U.S. actual sales, decreasing to 30% of profits from U.S. actual sales in excess of $400 million.

We are also entitled to low double-digit royalties on ex-U.S. net sales and have the option to co-promote in the United States. The co-promote option will allow us to provide up to 25% of the total sales force for GDC-0973 in the U.S.

So I’ll close here by reiterating that we’re excited to have two mechanistically distinct compounds advancing in a pivotal trial across multiple indications. Cabozantinib remains our top priority, building on the positive cabo data from EXAM, our first Phase 3 pivotal trial for MTC and the encouraging results from our broad Phase 2 program in CRPC we’re enrolling the two COMET Phase 3 trials in prostate cancer.

In addition, we’re exploring additional pivotal trials for cabo in RCC and HCC, and potentially other indications. Our partner pipeline continues to evolve, first with GDC-0973 moving into a first line metastatic melanoma Phase 3 pivotal trial by Roche and Genentech.

Additional compounds continued to advance in Phase 2, including the two PI3K inhibitors with Sanofi, foretinib with GSK, the hedgehog antagonist XL139 or BMS-833923 with Bristol-Myers, the MR antagonist, XL550 or CS-3150 with Daiichi Sankyo.

With one successful pivotal trial, [pre-pivotal] trials ongoing and two more envisioned for the near future, we believe Exelixis is in an enviable position to build sustainable value and growth with cabozantinib and other compounds we have substantial equity in.

So I’ll stop there after the short intro and turn the call over to Gisela for a cabo development update and then Frank for a review of our Q3 financial performance. Gisela?

Gisela Schwab

Thank you, Mike. In my update today, excuse me, I will focus on the following areas, the MTC filing, CRPC and a COMET-1 and 2 update, progress in our collaboration with CTEP and investigator-sponsored trials or ISTs and preparation for pivotal studies in new indications. I will also touch on a brief overview of recent publications.

So, with that, I will start with the MTC filing status. We have filed the NDA for MTC in May 2012 and are now nearing the PDUFA date of November 29, 2012 for our U.S. filing.

Regarding the ex-U.S. filing, as planned, our Marketing Authorization Application or MAA submission, has been sent to the EMA, European Medicines Agency, recently and is now undergoing validation at the EMA.

Regarding other news on MTC, we have presented data from our Phase 3 study in MTC at three key conferences, the European Thyroid Association or ETA, the American Thyroid Association or ATA and the European Society of Medical Oncology or ESMO.

At the ETA Annual Conference in early September and at the Annual ATA Conference in late September, investigators represented further data focused on the evaluation of biomarkers and provided further insight in pre-specified patient sub-analyses, showing activity of cabozantinib across a variety of pre-specified subsets including REC mutational status and prior treatment with TKI.

We’ve also seen activity in a post-hoc analysis of patients with mutations of the BRAF gene which is generally thought to be a genetic alteration associated with food prognosis. An additional presentation at the recent ESMO Conference focused on exposure response analysis and indicated that patients with variant exposure to cabozantinib derived similar benefits with respect to the primary end point at PR.

Regarding the CRPC program, I would like to start the update by giving you a brief overview on recently presented interim data from the non-randomized expansion cohort of our randomized discontinuation trials, patients receiving 40-milligram daily dose of cabozantinib.

Dr. Johann de Bono presented at ESMO a few weeks ago for the first time data on this cohort of patients with CRPC who were all previously treated and had failed prior docetaxel and who could have received additional prior treatments. In fact, 67% had received prior abiraterone or enzalutamide and 25% had received prior cabazitaxel, 71% of patients had received at least two prior lines of therapy for CRPC.

Clinically significant pain that’s defined as a baseline pain’s score by Brief Pain Inventory or BPI of greater than or equal to 4 was present in 53% of patients and 45% of patients received chronic narcotic administration.

Interim data from this study with 40-milligram of cabozantinib, was consistent with respect to anti-tumor activity, compared with the 100-milligram data published earlier this year at ASCO by Dr. Matthew Smith. However, tolerability was improved compared to the 100-milligram cohort.

Specifically, we saw a bone scan response evaluated by an independent radiology committee in 49% of patients with another 29% of patients achieving stable disease and 14% of patients having a best response of progressive disease.

Importantly, Dr. de Bono showed initial data from ongoing efforts, focused on documenting the direct impact of cabozantinib onto malignancy in the bone of prostate cancer patients.

The initial data suggest that cabozantinib’s effect on bone scan, are linked to induction of tumor necrosis in bone metastasis. In a patient with complete resolution of pelvic metastatic lesions and bone scan, diffusion-weighted magnetic resonance imaging or MRI findings were consistent with tumor necrosis occurring within the bone metastases.

Progression free survival was 4.2 months in this cohort and that was regardless of prior therapy status. 79% of the valuable patients had tumor regression and measurable lesions, and pain response was seen in 69% of the valuable patients with reduction in narcotic medication seen in 54%.

Decrease in the bone biomarkers of cross-linked, C-terminal telopeptides of type 1 collagen or CTX. And bone-specific alkaline phosphatase were also observed and we mare consistent with the data previously shown for the 100-milligram cohort.

Adverse events were generally less frequent than with the 100-milligram dose cohort and no great five adverse events were reported. Only 25% of patients experienced a dose reduction due to an adverse event.

These data show that a lower embedded tolerated dose of cabozantinib is active in previously treated patients with CRPC. And this data is important when thinking about the ongoing COMET-1 and 2 Phase 3 studies, both of which use a 60-milligram QD dose of cabozantinib.

Now, let me turn to a brief update on the ongoing development program in CRPC. COMET-1, our Phase 3 study was a primary end-point of overall survival, is actively enrolling patients now on three continents.

COMET-2 Phase 3 study with the primary end point of pain response is also actively enrolling patients. Side activations are ongoing and are in the steep phase of the activation curve, particularly for COMET-1 where we expect to open approximately 280 sites globally. All the activities that precede site activation are actively being worked on.

Regulatory submissions and approvals have proceeded as expected, while administrative aspects such as IRB approvals and contracting are taking a little more time than initially planned. The current number of activated sites is, therefore, slightly behind than initially projected. And as a result, patient enrollment has shifted compared to initial projections.

In our overall projections for the timeline to topline results for both COMET studies, we had built in time for site activation, enrollment and maturation of data. We believe that both studies can deliver topline results in 2014. While we continue to work towards a top line result readout, in the first half of 2014, we think it is prudent to widen the window of time a little bit for achieving this outcome.

Now, on to other indications, our CTEP and IST programs are proceeding well, and we are happy to report that the first two studies are now active under the CTEP IND. These consist of a Phase 1b study evaluating the combination of docetaxel and cabozantinib in CRPC patients and a Phase 2 study in patients with advanced bladder cancer.

CTEP has been very busy. And together with CTEP, we have completed review of 10 protocols, including the two I just mentioned. The eight studies that are not yet active are now going through the review processes, including IRB and scientific reviews at their respective sites, and we are expecting these studies to initiate in the coming months.

The CTEP program includes randomized Phase 2 studies in non-small lung cancer, first line renal cell cancer, melanoma and ovarian cancer. And additionally Phase 2 signal search studies in other tumor types, including endometrial cancer and sarcoma are also being planned, as our Phase 1b study is evaluating cabozantinib in combination with other agents.

Now regarding the IST program, 11 studies are now active and good progress has been made across the board. Indications and evaluation include CRPC, breast cancer, non-small cell lung cancer, multiple myeloma, pancreatic cancer and a study in patients with solid tumor and bone metastasis.

In addition to all these activities, we are now actively evaluating pivotal studies in other indications. These indications include, among other tumor types, renal cell cancer and hepatocellular cancer. At a high level both studies are planned for the second line setting in these indications.

An RCC study would compare cabozantinib versus an active comparative versus an HCC when we would compare against placebo given the absence of standard of care in this setting. We’re working with investigators in the final study designs, and expect to move towards regulatory discussions for some of the indications in the early part of 2013.

Now, let me close by mentioning another recent presentation at the ESMO Conference. Data from our Phase 1 study in Japanese patients showed a good tolerability at a 60-milligram dose in this population, along with signs of anti-tumor activity, particularly in non-small cell lung cancer patients, we’re seeing long lasting responses in four patients and stable disease in one patient.

This study will be expanded to further evaluate individual subsets of non-small cell lung cancer patients with different genetic makeup, including separate cohorts of patients with activating EGFR mutations with KRAS mutations and a cohort of patients with RET fusion gene or the RAS gene mutation.

The results from this Phase 1 study are of interest for two reasons. They show anti-tumor activity at a dose of 60-milligram or below, and they also indicate good tolerability at this dose level in the Japanese population, which will be important for future global studies that could include patients from Japan.

In summary, our plans going into the last months of the year are very focused. We are supporting our MTC filling towards the PDUFA date, and the preparations for a potential positive outcome are in full swing.

Our EMA filing has been submitted, and the highest priority is to execute on the COMET. Additionally, we are evaluating pivotal studies and other indications where good activity has been seen in Phase 2 RCC and HCC among them.

With that, I will hand the call over to Frank.

Frank Karbe

Thanks Gisela. I will cover several topics on today’s call including a summary of our Q3 financial results, the recap of our financing activities during the quarter and finally our financial outlook for the full year 2012.

Let me begin with our third quarter financial results. As usual, I will focus my comments on the highlights of our financial performance and refer you to our press release and today’s 10-Q filing for additional details.

Revenue for the quarter was 13.3 million which included a $5.5 million milestone from Daiichi Sankyo. This milestone was triggered by the enrollment of the first patient in a Phase 2 trial for MR compound XL550, which we out licensed in 2006.

Revenue in Q3, 2012 was lower than in Q3 a year ago mainly because Q3 last year included 110 million in accelerated deferred revenue associated with the termination of the BMS collaboration from cabozantinib and XL281, as well as approximately $9 million in revenue pertaining to our license in collaboration agreements with Sanofi.

R&D expenses decreased by approximately $6.8 million or 18% to $30.7 million compared to the third quarter last year. Mainly due to lower clinical trial expenses, lower allocations of general corporate costs and lower headcount expenses.

The decrease in clinical trial expenses primarily reflects the completion of various clinical pharmacology studies in 2011 in preparation for our filing for MTC as well as the wind down of the EXAM trial and our randomized discontinuation trial.

These decreases were partially offset by an increase in expenses associated with the COMET trials, increases in CMC expenses associated with our launch preparations as well as increases for various ISD trials.

G&A expenses decreased compared to the third quarter of last year by approximately 10% to $7.3 million, despite low allocations of general corporate costs through R&D and increases in marketing spend from preparation for potential launch of cabozantinib in MTC.

Expenses decreased across most other cost categories, with the biggest contribution coming from the lower rent expenses as a result of having successfully subleased significant portions of our campus.

Operating expense overall decreased by approximately $9.8 million or 20% to $38.8 million compared to the third quarter of last year, which in addition to the aforementioned reductions in costs, also incorporated decrease in restructuring charges year-over-year by approximately $2.2 million.

For other income expense, we incurred a net expense of $7.4 million compared to $1.8 million in the third quarter of last year. The increase in expense was primarily due to interest expense in connection with our convertible notes issued in August. Please note that our interest expense for the third quarter of 2012 includes $4.1 million of non-cash charges related to our convertible notes as well as the Deerfield Financing.

We ended the quarter with approximately $675 million in cash. We had cash inflows of approximately $425 million, mainly as a result of our dual tranche offering in August as well as the milestone from Daiichi Sankyo mentioned earlier.

Our dual tranche offering provided net proceeds of $138.4 million from the issuance of common stock as well as $277.7 million from the issuance of senior subordinated notes. The notes via interest at a rate of 4.25% per annum and have a seven-year maturity, maturing in August 2019, unless earlier converted, redeemed or repurchased.

Let me now turn to our outlook for the financial results for full year 2012. Our guidance for revenues remains unchanged in the range of $40 million to $60 million. We are lowering our operating expense guidance to a range of $160 million to $180 million.

There are several elements contributing to this change, namely the delay in COMET site activation, expenses for EXAM and the RDT study coming in lower than initially anticipated, as these studies ramped down and significant true savings across a number of other expense items, such as personnel, rent and utilities, legal fees and others, above and beyond our projections at the beginning of the year.

Finally, we’re increasing our year-end cash guidance, taking into account our recent financing activity and now expect to end the year with at least $600 million in cash.

With that, I will turn the call back over to Mike.

Mike Morrissey

All right. Thanks, Frank. I will close here by reiterating that the Exelixis’ team has been working hard on several important fronts, including the NDA review, enrolling the COMET trials and planning for additional pivotal trials. We think we made a lot of progress here and of course, none of this would be possible without the -- with the significant commitments from patients, caregivers and clinicians.

As always, I want to thank all the employees at Exelixis for their hard work, commitment and passion to move our company forward.

So, with that, we’ll stop here and open the call for questions. Thank you.

Question-and-Answer Session

Operator

(Operator Instructions) And our first question comes from the line of Eric Schmidt with Cowen and Company. Please proceed.

Eric Schmidt - Cowen & Company

Thanks for all your comments. I guess, the first question just for Gisela on the COMET trial startup issues, what specifically is taking a little bit longer in terms of the IRBs and the contracting, what maybe didn’t you anticipate? And maybe second part to the question, in terms of the sites that are open. Are they enrolling according to plan or is there likely to be some slowness even after you get through these barriers?

Gisela Schwab

Yeah. Thanks for the question. In terms of what is taking a little bit longer is really administrative aspects of contracting and that’s particularly in the summer months in Europe, taking sometimes a little bit longer, likewise IRB processes. And so that has resulted in a slight shift of the activations of sites.

We’re now in the very steep part of activating sites. And so when a little shift occurs, then it delays things by a couple of weeks or a month or so.

Eric Schmidt - Cowen & Company

And those…

Gisela Schwab

So administrative issues in terms of the study enrollment, there’s a lot of enthusiasm on the part of investigators and sites are being activated quite actively at this point. We are expecting for COMET-1 to have more than 50% of the sites active before year-end and recall, we only just started at the late May time frame of this year.

Eric Schmidt - Cowen & Company

So you are seeing enrollment in those trials that have gotten through sort of those site?

Gisela Schwab

Absolutely.

Eric Schmidt - Cowen & Company

Okay.

Gisela Schwab

Yeah.

Eric Schmidt - Cowen & Company

And then, maybe, I don’t know, perhaps for Mike, given the increasing importance that GDC-0973 is potentially having on your stock, looks like clinicaltrials.gov is forecasting this Phase 3 study potentially wrapping up in 2017 with a PFS end point. I know this is an unfair question because it’s not your trial, but do those time lines make sense to you and do you think that there will be a requirement for two Phase 3s in this indication?

Mike Morrissey

Okay. Those are all good questions. I’m really not in a position to comment on the conduct of those trials. I would recommend you listen to the Roche call post ESMO. They had a briefing on that information and they actually spoke to some of the timelines that were outlined on clinicaltrials.gov. So but beyond that we’re really not able to comment further on the development plan for melanoma in regard to GDC-0973.

Eric Schmidt - Cowen & Company

Okay. And then I just want to clarify the comments Gisela made about potential Phase 3 studies in renal cell and hepatocellular carcinoma for cabozantinib. Is it now the case that you’ve made a definitive go decision on those two Phase 3 studies and that seemingly each could start next year?

Gisela Schwab

So we are very actively working on the designs of such potential studies and preparations for potential regulatory meetings. I think with respect to ultimate decision to initiate, I would hold off a little bit at this point in time. We’ll have to step through the appropriate process, but we’re working full stream on those.

Eric Schmidt - Cowen & Company

Okay. Thank you.

Operator

And our next question comes from the line of Cory Kasimov with JPMorgan. Please proceed.

Karen Jay - JPMorgan

Hi. This is KJ in for Cory Kasimov. Thanks for taking the questions. I’ve got a few and the first one is to follow-up on the site activation. I know you’re careful is what you tell us, but can you give us a sense of where you are, you mentioned you’re on the steep stage of outside activation. But can you give us anything further on how far long you are in activating your target number sites especially for COMET-2 with the start in sort of late 2011 and 50 sites. I’m just wondering if that’s pretty close to being?

Gisela Schwab

Sure. So for COMET-2 by the end of the year we expect to have nearly all sites up and going. And for COMET-1, as I said earlier, we expect to have more than 50% of the sites up and going. And recall there are 280 sites planned for COMET-1.

Karen Jay - JPMorgan

All right. Okay. And then second question on the COMET trials. Do you have other independent monitoring committees that are doing safety and utility checks. And I’m just wondering if you’ve maybe had any for maybe at least COMET-2?

Gisela Schwab

There are indeed independent safety monitoring boards, absolutely. And they take place as described in the study plans. So, usually, they take place after the first number of patients have been enrolled and followed up for a certain amount of time and then they go quarterly. So that’s all going on plan.

Karen Jay - JPMorgan

Okay. Perfect. And my last question is for Frank. You have a really, really healthy cash balance that’s quite a bit higher than your peers. So I’m kind of wondering about your runway. So I don’t think there will be a problem with you finishing the COMET trials but could you use that cash for the co-promotion activities of 0973?

Frank Karbe

We, obviously, could. But with regards to the runway itself, I don’t think anything has changed from what we’ve said during the offering itself in August. And what we said then was that we expect those proceeds to be sufficient to certainly complete the COMET trials and also start up one or several Phase 3 studies in additional indications. And all of that is still true.

How long the runway really extends then, to some degree depends what the revenue ramp looks like on cabo because we’re obviously -- if you talk about the end of the COMETs, we’re looking out into 2014. And we really have to see what our revenues look like at that point. So for the time being we are well funded to pursue all of the plans we currently have on deck.

Karen Jay - JPMorgan

Great. Thank you.

Operator

And our next question comes from the line of Joel Sendek with Stifel Nicolaus. Please proceed.

Joel Sendek - Stifel Nicolaus

Thanks. A couple questions for me too. So, Gisela, just to make crystal clear here as far as the COMET data, are you guiding to the second half of ‘14 with a possibility that it might come earlier or pretty much we’re looking at second half of ‘14?

Gisela Schwab

So we’re working towards delivering in the first half of ‘14, but we’re recognizing that with the slight delay that we’ve been talking about. It is prudent to widen that window a little bit. So we’re guiding towards 2014 delivery.

Joel Sendek - Stifel Nicolaus

Okay. All right. So you’re still hoping, if you get everyone up and running, that you can still make the first half of ‘14.

Gisela Schwab

Yeah. That’s correct.

Joel Sendek - Stifel Nicolaus

Okay. And then when you describe the 25%, only 25% of the patients requiring dose reduction at the lower dose. It seems to me that you’re comfortable with that but might that still be a little bit high? Could you -- what was your expectation going into the study, and is there any way you can make it even more tolerable?

Gisela Schwab

I think the tolerability profile was actually quite good and 24% or 25% of patients’ dose reducing is not a very high number. We had observed in the 100 milligram of dose level of about 80% of patient’s dose reducing at least once. And so, we see a good tolerability and we see good maintenance of activity as I described. So, I think we’re quite pleased with the results.

Joel Sendek - Stifel Nicolaus

Okay. And then my last question is on the 0973. I just want to make clear, certainly prior to any kind of co-promotion or anything that your financial commitment to that is pretty much zero, is that correct?

Mike Morrissey

That is correct. We are involved in obviously the commercial and marketing end, which might take place earlier than the actual, any potential approval per se. But there is no development costs involved from our side.

Joel Sendek - Stifel Nicolaus

Thank you.

Operator

And our next question comes from the line of Biren Amin with Jefferies. Please proceed.

Biren Amin - Jefferies

Yeah. Thanks guys for taking my question. As I read the Q on the MEK inhibitor collaboration with Roche, it seems the company has a right to co-promote within 12 months of the first patient dose. So if I use that assumptions about a year’s time, we -- I guess anticipate your potential opt in for the co-promo.

What metrics would you use to exercise the opt in and I guess, how do you view the competitive dynamics of this market given GSK has a similar combo, MEK, BRAF that’s about six months ahead of the Roche program? Thanks.

Mike Morrissey

Yeah. You’re correct. Well, there’s a one-year window when we can opt in the co-promote, based upon the company being notified of FPI, that hasn’t happened yet, so that clock currently is not ticking. Okay, number one. I missed the second question there.

The third question is around the competitive dynamics. Obviously, there is other people in this space. Again, we’re not actively engaged in the planning or execution of the development phase of this project.

So, I can’t really comment on that per se besides just acknowledging the fact that this is certainly a very interesting space to be in right now. We think the data with 0973 looks encouraging based upon what we saw at ESMO and we’re certainly excited to be having, an opportunity to have a second compound in pivotal trials now with 0973.

Biren Amin - Jefferies

Okay. And question maybe on cabo, Dr. de Bono on the NRE trial at ESMO presented I guess radiographic PFS of about 4.1 or 4.2 months if you consider the definition from the prostate cancer working group to what would -- and using PFS from that definition, what would the PFS have been from that trial?

Gisela Schwab

It would be the same, I think.

Biren Amin - Jefferies

Okay. Great. Thank you.

Operator

And our next question comes from the line of Ryan Martins with Lazard Capital Markets. Please proceed.

Ryan Martins - Lazard Capital Markets

Hi. Just to a follow-up on the co-promote question from Biren earlier. It seems like there’s also language that talks about you necessarily having to have a certain interest structure commercially in order to exercise the co-promote option. Is that -- I mean do you believe if you do get the approval for MTC that the promotion infrastructure there would satisfy that option?

Mike Morrissey

Yeah. Ryan, it’s Mike. Yeah, I think that’s certainly a good place to start. Again, we don’t want to get into details around our commercial plans for cabo, but we certainly have interest in going in that direction and have plans to be able to build that out. So, as we move forward with that dialogue, we’ll be sharing that information with investors and be able to articulate kind of how that will roll out.

Ryan Martins - Lazard Capital Markets

Okay. And just on -- it’s probably for Gisela. On the HCC trial, I’m assuming that second line and I just curious as there is another drug out there c-Met inhibitor that’s going into a biomarker selected population. So, just curious as to how you think about that?

Gisela Schwab

Sure. Yeah. And it’s a second line study that is being contemplated. I think different from the other drug that you just mentioned that is moving forward in this space. We would not anticipate selecting patients and that’s due to the target profile of cabozantinib, which is much broader than MET, importantly includes EGFR.

And in the prior evaluation, which was presented at ASCO, we had a subsequent analysis for some of the patients, not all patients, about 50% of the patients, where we looked at MET expression and did not see a correlation of activity. In that case, tumor shrinkage was a MET over-expression versus not. So, we don’t feel we need to select the patient population.

Ryan Martins - Lazard Capital Markets

Okay. And then one final one is -- if you do have the MTC approval, would you anticipate seeking any Compendia listing in prostate?

Gisela Schwab

In terms of Compendia listing, I think that’s a little bit premature to comment on. I think we are certainly committed to publishing our data that has been presented at conferences and peer reviewed journals and that certainly an effort that is ongoing with high priority.

Ryan Martins - Lazard Capital Markets

Okay. Thank you.

Operator

(Operator Instructions) And our next question comes from the line of Echo He with Maxim Group. Please proceed.

Echo He - Maxim Group

Hi. Thank you for taking my questions. Just a couple from -- the first one and I remember I saw somewhere you said that the COMET-1 or COMET-2 trials expenses are less than expected, why was that?

And the second one is, you have this long-term investment and this is significantly higher in this quarter than the last quarter and what is that one? And you put that in your lump together with your cash and what is that basis? Is that very liquid or something?

Frank Karbe

Well, let me try to rest both of these. The first one, why expenses a little bit lower, well that’s linked to the site activation that Gisela alluded to. And then secondly, I think your question with regards to our balance sheet, that’s simply a reflection of a dual trench offering that we did in August, which brought in net proceeds of $416 million and some of these proceeds, of course are now categorized as long-term investments.

Echo He - Maxim Group

Okay. I understand the second one. The first one you said related to your site selection. I mean, some certain site are costing less than others, right and were costing less than you previously planned?

Frank Karbe

We said site activation.

Echo He - Maxim Group

So, do you mean that’s a less number of site activated during the quarter or as scheduled than you or less than as scheduled?

Gisela Schwab

That’s right.

Mike Morrissey

That’s correct.

Gisela Schwab

So, that’s a little bit -- I’m sorry to jump in. Its a little bit right shifted so they’re being activated a month or so later or a couple of months later.

Echo He - Maxim Group

Okay. I got you. Was that because -- was there any technical reason for that, any patient enrollment difficulties were anything could…

Gisela Schwab

No. No. The site activation precedes obviously the patient enrollment. And the issue really is -- has been over the summer months, more the administrative execution on contracts in particular in the European sites and that is picking up now very nicely.

Echo He - Maxim Group

Okay. I understand. Thank you so much.

Gisela Schwab

Sure.

Operator

Ladies and gentlemen, with no further questions this concludes today’s question-and-answer session. I would now like to turn the call back over to Mr. Mike Morrissey for closing remarks.

Mike Morrissey

Okay. Again, thanks for your time and interest today. Looking forward to keeping you updated on progress as we move forward. Have a great day. Thank you.

Operator

Ladies and gentlemen, we thank you for your participation in today’s conference. This concludes the presentation. And you may now disconnect. Have a good day.