Earnings Labs

Exelixis, Inc. (EXEL)

Q2 2008 Earnings Call· Tue, Aug 5, 2008

$44.74

-0.42%

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Transcript

Operator

Operator

Good day, ladies and gentleman, and welcome to the Q2 2008 financial results business update conference call. (Operator Instructions). I will now like to turn the call over to Mr. Charles Butler, Head of Investor Relations. Please proceed sir.

Charles Butler

Head of Investor Relations

Thank you. Thank you for everyone joining us on our Q2 2008 financial results conference call. Joining me today are George, Frank, and Mike, our CEO and CFO and President of R&D respectively. George will give some highlights of the quarter and then Frank will walk through the financials and Mike will provide an R&D update. But before I turn the call over to George, just like to say that we posted our earnings press release, as well as the slide presentation that accompanies our prepared remarks on our website, and lastly, before I turn the call over, let me just read our forward-looking statements. I would like to note that during our presentation today, we will be making certain statements that are forward-looking, including without limitation, statements related to the timing and impact of potential compound selections of our GFK, the timing and success of business development activities, our year end financial guidance, the future development and potential efficacy of our compounds and the timing of initiation of clinical trials. These statements are only predictions and are based upon our current assumption and expectations and are subject to risks and uncertainties. Our actual results and timing of events could differ materially from those anticipated in such forward-looking statements because of risks discussed in, our presentation materials, the comments made during this presentation and the risk factor sections of our 10-Q for the quarter ended June 27 2008, and our other reports filed with the Securities & Exchange Commission. We expressly disclaim any duty, obligation or undertaking to make any updates, revisions to any forward-looking statements. And with that, I will turn the call over to George.

George Scangos

Management

Okay. Thanks, Charles, and thanks to all of you for tuning in today. I think we had an very active quarter with significant data presented on five of our key compounds at ASCO and at the European Hematology Association Meeting signing of a $150 million finance facility to improve our financial position, and the announcement that our successful six year collaboration with GFK, will conclude in October. Also, we recently announced the beginning of a Phase III pivotal trial for XL184 and the submission of the proof-of-concept package for XL184 to GSK. Finally, after the quarter, we announced that we had hired Frances Heller, our formerly Head of Strategic Alliances for the Novartis Institute for Biomedical Research, as our Head of Business Development. So before turning the call over to Frank and Mike, who will provide financial and R&D updates, I want to take a few minutes to discuss these important events and also to provide a snapshot of important upcoming events for the rest of 2008. But first at ASCO, we had seven presentations which is the largest presence at ASCO in the company's history. And our clinical investigators reported substantial new data on four of our lead compounds, that's XL184, 765, 647 and 880. The highlights included the following. There was clear anti-tumor activity for XL184 in patients with medullary thyroid cancer, with a 100% disease control rate, hard to get better than that and a 53% response rate. The data supported initiation of the Phase III trial of XL184 in medullary thyroid cancer patients and that trial started in July. We have proof of mechanism data for the PI3 kinase pathway inhibition by XL765, in both tumor and surrogate tissues from patients or data presented showing an impressive 96% disease control rate for XL880, inpapillary renal cell…

Frank Karbe

Management

Thanks, George. We have made significant progress in advancing our business and the Q2 financial results reflect this progress, and we are in-line with our expectations. As George mentioned, we are currently engaged in multiple business development discussions that has the potential to bring new cash into the company and offload future development expenses. While the exact timing of these deals is difficult to predict, we are confident that we will bring some of our discussions to a successful close. The Deerfield facility, even without drawing on it, puts us in a stronger position and gives us the flexibility to see our way through those discussions. It also buys us time to see some important business and pipeline milestones fall into place, such as GSK's decision on XL184 for example and then determine the proper path forward for us. So in all, we are excited about the level of clarity, we will be able to provide later this year, as it relates to our strategy going forward. We are confident that we can substantially strengthen the financial position of the company through new business development activities. Now let me turn to the second quarter financial results in detail, and as a reminder, we are reporting our financial results on a GAAP basis only. And as usual, the complete press release with our results can be accessed through our website at Exelixis.com. I will start with revenues. Revenues for the second quarter '08 were $30.4 million compared to $29.3 million for the comparable year in '07. The increase from '07 to '08 was primarily due to the conclusion of our collaboration with GSK on October 27th 2008, which shortens the term over which we had historically recognized revenue and therefore it results in an accelerated recognition of revenue until October of…

Mike Morrissey

Management

Thank you, Frank. As George noted, we have recently initiated our Phase III trial of XL184, in medullary thyroid cancer or MTC. XL184 is a small molecule tyrosine kinase inhibitor targeting MET, RET and VEGFR2. We reached agreement with the FDA on this Phase III registrational trial, via the special protocol assessment process, and have also discussed the trial design with European regulatory agencies. The study is now open. The initiation of this trial was based on encouraging data that were presented at this year's ASCO meeting. Safety and clinical activity data were presented from an ongoing Phase I 1 trial of XL184 in 69 patients with various solid tumors including patients with metastatic MTC. These data showed a disease control rate of 100% in the valuable MTC patients, meaning that all these patients had partial responses or prolonged stable disease for more than three months. In addition of the 17 MTC patients with measurable disease, nine of them or at 53% experienced partial responses. Most of the MTC patients in the trial had previously failed other treatments including TKIs with anti-RET activity such as vandetanib, sorafenib or motesanib. The Phase III trial was designed in collaboration with internationally renowned experts in the field of thyroid cancer that's a randomized placebo control double-blind study of XL184 as a single agent in 315 patients with unresectable locally advanced or metastatic MTC. Patients are randomized in a 2:1 ratio to receive XL184 or placebo administered as a daily oral dose. The primary endpoint is duration of progression-free survival or PFS. In a planned event driven analysis, the study size provides 90% power to detect a 75% increase in PFS in patients with documented progressive disease, prior to study entry. Secondary endpoints will include overall survival, objective tumor response rate, and changes in…

Operator

Operator

(Operator Instructions). Your first question comes from the line of Joel Sendek. Please proceed.

Joel Sendek - Lazard Capital Markets

Analyst

Hi, thanks. I have two questions. Can you just go over what the plan is for XL647? Did you say you are going to wait to get a partner until you move it because I guess the previous plan was to move that into front line lung cancer? Then I have a question on 184 after that.

George Scangos

Management

Yes, I think for 647, we have been in a number of partnership discussions. As we look at our pipeline now, and let's say the return of compounds or lets say freeing up of the compounds in the GSK collaboration becomes imminent, so that we are looking down the road a few months from now, in couple of months from now of having eight or nine compounds in our proprietary pipeline, it is very clear we can't develop all of them on our own. And we've begun a prioritization process of these compounds, so that we can be focused and allocate our resources toward those compounds that will provide us the biggest return in a reasonable period of time. So compounds that address, or let's say whose clinical development path is low risk, short time, relatively low cost to get to the market are attractive ones for us to take forward on our own. Other compounds, certainly not only XL647 but including XL647 have substantial potential but have much more complicated clinical development paths, and we think those are best suited for development in collaboration with a partner. So, as we look at XL647, certainly the compound has activity in non-small cell lung cancer. I think it can take its place as a compound that treats lung cancer. I do not think given where we are today, and given the compounds in our pipeline it makes, that XL647 reaches or let's say meet those criteria development paths little more complicated. Accordingly, we don't want to begin a development project where we don't want to complete it unless we have a partner. So, in the absence of a partner, we do not intend to further develop XL647. We are still having partnership discussions. We think the compound does have merit. So if we get a partner, we will take that compound forward.

Joel Sendek - Lazard Capital Markets

Analyst

Okay, I understand. And just quickly on 184, can you give us some feeling for how long enrollment will take for Phase III?

George Scangos

Management

We are projecting right now between 14 to 18 months.

Joel Sendek - Lazard Capital Markets

Analyst

Okay. Thank you.

Operator

Operator

Your next question comes from the line of John Sonnier. Please proceed.

John Sonnier -

Analyst · John Sonnier. Please proceed

Thanks a lot, it is John Sonnier, William Blair, I appreciate the update, just another question on 647, I think the original partnering strategy was to try to hang on to US rights, if possible. I am just wondering if you are now asking a third-party to take on a greater proportion of the development burden, are you more flexible with that thinking? And I guess parallel to that, I believe it's also a Symphony compounds., if you can help us think about what happens if it's partnered and what happens if it's not with that relationship? Thanks.

George Scangos

Management

Yes, I think implicit in saying that and in the absence of a partner we do not intend to further develop the compound is in the absence of a partner we will not repurchase the compounds from Symphony. We are partnership discussions; our goal is to establish a partnership in which the upfront milestone payments from the partner can cover the repurchase cost from Symphony, and the majority of the clinical development expenses. So, if we're successful, we will go down that road, if we are not, then we don't intend to take that compound further.

John Sonnier - William Blair

Analyst · John Sonnier. Please proceed

Thank you.

Operator

Operator

(Operator Instructions) Your next question comes from the line of Cory Kasimov. Please proceed.

Mona Ashiya - JPMorgan

Analyst · Cory Kasimov. Please proceed

Hi, this is Mona Ashiya for Cory, actually. Just a question on 184, so, you know RET, obviously plays a key role in MTC, but as far as other settings such as lung cancer and GBM, I wondered if you could speak a bit more about the rationale? And moving into these settings, is it largely the inhibition of VEGF that's driving the decision to go there? And also related to that, is there anything that you've seen in your pharmacodynamic results with 184 that's shaping your expectations in these other settings?

George Scangos

Management

I think in both non-small cell lung cancer, GBM and really a wide variety of histologies. I think the target profile of XL184 which focuses on both VEGFR2 and MET, really addresses the genetics of those different histologies in a very powerful way. So again, due to the MET-inhibition and the potent VEGFR2-inhibition, we see a very strong potential for the compound in a wide range of histologies. We had a lot of pharmacodynamic data at the ASCO meeting and I think that obviously from my point of view helped us really set the stage for how that compound is behaving in the clinical study.

Mona Ashiya - JPMorgan

Analyst · Cory Kasimov. Please proceed

And that's very helpful. And then, just another question actually on the PI3 kinase program. So you have represented some very interesting and exciting data at ASCO. I was just wondering if from a strategic standpoint, what you are seeing in terms of the enthusiasm from potential partners, and at what stage would you consider partnering these programs?

George Scangos

Management

Yes, I think your statement that we presented exciting data at ASCO was shared by a number of pharmaceutical companies as we have had a number of inbound calls subsequent to ASCO. We are having discussions with a number of companies around those PI3 compounds. Those are compounds where again, the development path is complicated, its market potential is huge. The number of trials we would like to do simultaneously is very large in order to maximize the market potential for those compounds. So we think those compounds also are very good ones to develop in collaboration with a partner and we are having those discussions.

Mona Ashiya - JPMorgan

Analyst · Cory Kasimov. Please proceed

Thanks very much.

Operator

Operator

(Operator Instructions). At this time, I would like to turn the call back over to George Scangos.

George Scangos

Management

Okay. Thanks. I guess when we talk for half hour, we wear everybody out. So let me thank everybody for your attention today. I would like to reiterate Mike's comments about thanking all of our employees, for their individual and collective work. Thank you for your interest. With that, we'll sign off.

Operator

Operator

Thank you for your participation in today's conference. This concludes the presentation, you may now disconnect. Good day.