Exelixis Inc (EXEL) 2016 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Exelixis Second Quarter 2016 Financial Results conference call. My name is Bryan, and I will be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Investor Relations. Please proceed.

Thank you, Bryan, and thank you all for joining us for the Exelixis Second Quarter 2016 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, PJ Haley, our Vice President of Commercial, and Gisela Schwab, our Chief Medical Officer, and who will together review our corporate, financial, commercial, and development progress for the quarter ended July 1, 2016, as well as our recent key development and corporate events. Peter Lamb, our Chief Scientific Officer, is also with us and will participate in the question and answer session of the call.

During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the Company. This includes statements about possible developments regarding clinical, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents Exelixis files from time to time with the Securities and Exchange Commission which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the Company verbally and in writing today, including, without limitation, risks and uncertainties related to product commercial success and market competition, regulatory review and approval processes, availability of data at the referenced times, conducting clinical trials and compliance with applicable regulatory requirement, Exelixis's dependence on its collaboration partners and ability to maintain its rights under existing collaborations, costs associated with commercialization, research, and development, and any other activities and the sufficiency of Exelixis' capital and other resources, over time.

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

All right. Thank you, Susan, and thanks to everyone for joining us on the call today.

We've had a very eventful second quarter, and I'll start today with a brief overview of our key milestones from the last few months before turning the call over to Chris, PJ, and Gisela, who will provide additional details on our Q2 financials, the CABOMETYX launch, and our development activities, respectively.

The key milestones from the second quarter of 2016 include, first, the FDA approval of CABOMETYX to treat patients with advanced renal cell carcinoma, or RCC, who have received prior anti-angiogenic therapy. Second, the well-executed initial phase of the CABOMETYX launch in the US, which resulted in the recording of the first sales of this new drug during the final nine weeks of Q2. Third, the presentation of 18 abstracts featuring Exelixis compounds at ASCO, including noteworthy updates on the METEOR overall survival data and the cobimetinib-atezolizumab combination data in a cohort of advanced colorectal cancer patients. Fourth, announcement of positive top line results from CABOSUN, the randomized phase 2 trial of cabozantinib in patients with previously untreated advanced RCC, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared with sunitinib in patients with intermediate- or poor-risk RCC. And finally, fifth, we announced just a little more than a week ago that we have continued to make progress with our partner, Ipsen, on the regulatory review for CABOMETYX in Europe with the receipt of a positive opinion from CHMP, which will be reviewed by the European Commission in the coming months.

I'll spend a few minutes providing a bit more color around the launch and initial sales numbers before passing the call over to Chris. Let me reiterate that executing a new product launch is a challenging undertaking, especially for a small biotech company, and I am very pleased by the way in which our entire team has pulled together under considerable time and competitive pressure to ensure that we initiated and will maintain a smooth and effective launch for CABOMETYX.

Importantly, we were able to get commercial drug into the distribution chain and fill the first prescriptions for patients in just three days following FDA approval of CABOMETYX. Since then, our sales team has been working hard to educate physicians about the CABOMETYX data in the prescribing information. Post-approval, CABOMETYX generated $17.6 million in net product revenue during the final nine weeks of 2Q. Net product revenues for the second quarter of 2016, including sales of COMETRIQ, were $31.6 million. We are encouraged by the strong initial uptake observed for CABOMETYX in the marketplace, which Chris and PJ will discuss shortly in greater detail.

We believe that these early CABOMETYX commercial results reflect the strength of the METEOR data and the compelling trifecta of benefit in three key efficacy endpoints, specifically overall survival, progression-free survival, and objective response rate, in addition to the intense preparation that preceded the launch. It's important to note that it's still early days, so we'll continue to be conservative in our view of the key components of the launch [as] seen to date. Due to the highly competitive dynamic in the advanced RCC indication, we'll also remain somewhat circumspect today in the review of our detailed commercial strategy, tactics, and key metrics for the CABOMETYX launch, both here in our prepared remarks and in the Q&A commentary that will follow shortly.

The entire team has been energized by the approval and launch of CABOMETYX and by the initial positive reaction it has received. As we've commented previously, our commercial and medical affairs teams are fully staffed, extensively trained, and have been actively meeting with healthcare providers since approval. This is a very mature and motivated team that we believe will enable us to compete aggressively in the RCC marketplace and build upon the initial momentum that we have achieved with CABOMETYX. As we outlined on the approval conference call, we expect to compete for every eligible advanced RCC patient, for every script, for every fill and refill, on every single day, based on the strength of the data in the CABOMETYX USPI and the experience, expertise, and energy of our commercial team.

So, with that, I'll turn the call over to Chris.

Thanks, Mike.

Before I start, I want to note that I'll be speaking to the financial data referenced in slides eight through 14 in our earnings presentation. These slides include comparisons to both the second quarter of 2015 and the first quarter of 2016 for your reference.

Net revenues for the quarter ended June 30, 2016 were $36.3 million compared to $8 million for the comparable period in 2015. Net revenues for the second quarter of 2016 includes $31.6 million of net product revenue compared to $8 million for the comparable period in 2015. Product revenues for CABOMETYX and COMETRIQ are both recognized using the sell-in method of revenue recognition. The increase in net product revenues for the three months ended June 30, 2016 as compared to the same period in 2015 reflects the impact of the commercial launch of CABOMETYX, as well as an increase in the COMETRIQ revenues.

Net product revenues for CABOMETYX and COMETRIQ were $17.6 million and $14 million respectively for the quarter ended June 30, 2016. Net product revenues during the quarter were impacted by approximately $6.5 million to $7 million related to channel inventory build during the initial launch period for CABOMETYX.

Net revenues for the quarter ended June 30, 2016 also includes $3.6 million of license revenues recognized from the upfront payment we received from Ipsen under our collaboration and license agreement, and $1 million of royalties on ex-US net sales of Cotellic. We recognize Cotellic royalty revenue on a one-quarter lag, and consequently the Cotellic royalty revenue for the quarter ended June 30, 2016 relates to Roche's first quarter 2016 ex-US Cotellic net revenue. There was no such royalty or license revenue during the comparable period in 2015.

Research and development expenses for the quarter ended June 30, 2016 were $23 million compared to $24.5 million for the comparable period in 2015. The decrease was primarily related to a decrease in clinical trial costs and the allocation of general corporate costs. Those decreases were partially offset by increases in personnel-related expenses resulting from an increase in headcount predominantly associated with the build-out of our Medical Science Liaison organization and an increase in consulting and outside services.

Selling, general and administrative expenses for the quarter ended June 30, 2016 were $35.8 million compared to $12.8 million for the comparable period in 2015. The increase was primarily related to an increase in personnel-related expenses resulting from an increase in headcount predominantly connected to the expansion of our US sales force and outside services expenses supporting the commercialization and launch of CABOMETYX.

Other income and expense net for the quarter ended June 30, 2016 was a net expense of $11.9 million compared to $12.1 million for the comparable period in 2015. The net expense is comprised primarily of interest expense, which includes $7.4 million of non-cash expense related to the accretion of the discounts on both the 4.25% Convertible Senior Subordinated Notes due in 2019 and the Company's indebtedness under our Secured Convertible Notes due in 2018 held by entities associated with Deerfield for the quarter ended June 30, 2016, as compared to $7.2 million for the comparable period in 2015.

Net loss for the quarter ended June 30, 2016 was $37 million, or $0.16 per share, compared to $43.4 million, or $0.22 per share for the comparable period in 2015. The decreased net loss for the quarter was primarily due to an increase in net revenues and a decrease in research and development expenses, which were partially offset by an increase in selling, general and administrative expenses.

Now, turning to our financial guidance for 2016, we are refining our previously provided guidance. Total operating expenses for the full year will be between $250 million and $270 million. This guidance includes approximately $30 million of non-cash costs and expenses related primarily to stock-based compensation expense. And with regards to our cash in 2016, at June 30, 2016, we had cash and cash equivalents, short- and long-term investments, and long-term restricted cash and investments totaling $384 million.

As we outlined on our previous earnings calls, we will not be providing cash guidance for this year because we are in the midst of a dynamic launch of CABOMETYX, which makes it extremely difficult to predict our final year-end cash position. With the cash we had to start the year, the upfront payment, and anticipated EU approval and launch milestones from Ipsen, growing revenue from product sales, and continued expense management, we expect that we will be in a very healthy cash position at year-end. We look forward to updating you with our revenue and overall financial performance over the course of this year.

And with that, I'll turn the call over to PJ.

Thank you, Chris.

We are very encouraged with the initial launch phase of CABOMETYX. Our commercial organization was fully enabled, trained, and ready to go at the time of approval in April, and our sales team immediately began calling on customers, including oncologists, nurses, physician assistants, and pharmacists. Given the fortuitous timing, Exelixis had a robust promotional presence at ASCO, and we were able to maximize the opportunity of the conference to educate a significant number of physicians on the METEOR data, for which there was a high level of interest.

Since approval, CABOMETYX is experiencing rapid and broad uptake in the marketplace. Although it is early in the launch, we are seeing encouraging trends in prescriber adoption. Approximately 75% of prescribers are new to cabozantinib in the sense that they hadn't previously written Cometriq. The rapid new prescriber adoption that we are seeing appears to confirm our conviction that CABOMETYX addresses a significant unmet medical need in advanced renal cell carcinoma.

In fact, the feedback we are hearing from our customers regarding the METEOR data and the trifecta of improvement in the efficacy endpoints of overall survival, progression-free survival, and objective response rate is positive and encouraging. This is leading to adoption trends across various segments of the market, including both the academic and community prescribers. It is important to note that we are seeing strong uptake of CABOMETYX across both the second- and third-line settings.

I will now turn to market access. Our channel was fully functioning shortly after approval, and we are encouraged that all our channel partners have begun reordering on a regular basis. On the payer front, our team has had productive conversations with our target payers representing the vast majority of covered lives.

Similar to physician feedback, payer feedback has been positive based on the clinical value of the METEOR data. As anticipated, there have not been any significant challenges securing coverage and getting appropriate patients on therapy. While it is still early days, patients have started receiving refills of CABOMETYX. Ensuring every eligible patient receives therapy is extremely important to us. The Exelixis Access Services, or EASE program, is designed to be best-in-class and is functioning well to ensure that all eligible patients receive CABOMETYX therapy.

Now I would like to turn to the dynamics of the Cometriq business. On our Q1 call, we described the increase in new patient starts and prescriber adoption for Cometriq in RCC. This trend continued in Q2 until the approval of CABOMETYX. Since then, we have observed two important trends in the utilization of Cometriq in RCC. First, very few RCC patients new to therapy are being prescribed Cometriq as they are now being prescribed CABOMETYX. Also, the majority of patients receiving Cometriq for RCC continue to receive refills of Cometriq, with a small number switching to CABOMETYX. Given this trend, we expect Cometriq revenue to gradually decline over time as RCC patients come off of Cometriq therapy while new patients initiate therapy with CABOMETYX. COMETRIQ demand in medullary thyroid cancer remains stable, as it has been for several quarters.

While the launch of CABOMETYX is off to an encouraging start, there is significant opportunity remaining in the US market, where there are approximately 17,000 previously treated patients with advanced RCC. Our deeply experienced commercial team is executing at a high level on our launch plans in this competitive market as they work to ensure appropriate patients with advanced RCC have the opportunity to benefit from CABOMETYX.

I would like to thank the entire commercial team, and particularly the sales force, for their tireless efforts and dedication. We continue to be motivated to compete in this dynamic market to bring CABOMETYX to every eligible patient as we build on the positive momentum of our launch.

And now, I will turn the call over to Gisela.

Thank you, PJ. I will focus today on a brief regulatory update for CABOMETYX in advanced RCC. I will then speak about recent top line data from a randomized phase 2 trial in the first line setting of RCC, and I will also provide an update on our other ongoing trials for cabozantinib.

Before that, I'd like to comment on the recent ASCO meeting in early June. Eighteen presentations featured results from studies of Exelixis discovered compounds at this conference. Most notable was the oral presentation by Dr. Toni Choueiri of the overall survival results from METEOR showing a highly statistically significant and clinically meaningful improvement in overall survival for cabozantinib as compared with everolimus.

These results were also concurrently published in the Lancet Oncology. Other presentations on cabozantinib focused on important subset analyses from METEOR as well as phase 2 data from studies in bladder cancer and endometrial cancer performed by our collaborators in the NCI-CTEP program.

Cobimetinib, the Exelixis-discovered MEK inhibitor that is being developed by our partner Genentech, was also featured in multiple presentations. Most notable were the results from a phase 1b study of Cobimetinib and atezolizumab, the PDL-1 antibody, in previously treated patients with advanced colorectal cancer.

This study showed antitumor activity with a 17% objective response rate and tolerability of the combination, and these data provided the basis for the now ongoing phase 3 study, COTEZO, of cobimetinib combined with atezolizumab, or atezolizumab alone versus regorafenib in the third-line treatment setting of colorectal cancer patients.

Now, I'd like to turn to a brief regulatory update for CABOMETYX. We had filed the NDA for CABOMETYX in December of 2015 with the FDA, and in January 2016 we filed the MAA with the European Medicines Agency, or EMA.

EMA granted CABOMETYX accelerated review status, and we have recently announced that our partner, Ipsen, was notified of a positive opinion from CHMP recommending approval of CABOMETYX to the European Commission, who will make the ultimate decision. We are very pleased that this milestone was achieved within the time foreseen for an accelerated review. With that, we expect regulatory approval for CABOMETYX in the EU in the September timeframe, and our partner, Ipsen, is actively preparing for launch of CABOMETYX in Europe.

Let me now turn to the development of cabozantinib in other indications. Our ongoing phase 3 study in second line treatment of hepatocellular cancer, or HCC, continues to accrue patients globally. The trial, called CELESTIAL, is a randomized placebo-controlled study evaluating cabozantinib versus placebo in patients with advanced HCC who have received prior sorafenib. The primary endpoint of the trial is overall survival. We continue to expect results for this study in the 2017 timeframe.

Additionally, to our in-house development efforts, our ongoing Investigator-Sponsored Trial, or IST program, and the CTEP program span a total of 45 planned or ongoing trials. These include randomized phase 2 trials, as well as single-agent studies and combination studies, with targeted agents as well as immune checkpoint inhibitors in a variety of indications.

Importantly, we have recently announced positive top line results for a randomized phase 2 study in the first line setting advanced RCC that is ongoing in the cooperative group The ALLIANCE under the CTEP IND. The CABOSUN trial compares cabozantinib versus sunitinib in first-line therapy of intermediate or poor-risk patients per the standard risk classification.

The primary endpoint of the trial is progression-free survival. The study recently met its primary endpoint of significantly improving progression-free survival with cabozantinib as compared to the current standard of care in this setting, sunitinib. This is the first time any agent has outperformed sunitinib in its key indication of first line RCC, and we are very pleased with these results.

We have initiated a dialogue with regulatory agencies about these results to determine the potential for regulatory filings and next steps in the development of cabozantinib in the treatment of first line RCC. We'll share more definitive information on the regulatory and development path when available. We are actively working with the ALLIANCE to access all data from the trial, and expect the CABOSUN results to be presented at a medical conference later this year.

In addition, our CTEP collaborators are conducting a phase 1b study evaluating the combination of cabozantinib plus nivolumab, with or without ipilimumab, in patients with genitourinary cancers, including RCC. This study was opened for enrollment in July 2015 and continues to actively accrue patients. Data on the tolerability and anti-tumor activity of the combinations studied in this early-phase trial could set the stage for later-phase evaluation not only in the genitourinary setting, including RCC and bladder cancer, but in other areas as well, like non-small cell lung cancer and histologies that appear sensitive to both agents.

And lastly, at the upcoming ESMO conference in early October 2016 in Copenhagen, we anticipate presentation of various data sets. To date, we have been informed about six accepted presentations for cabozantinib, including further METEOR subset analyses, the Quality of Life analysis from METEOR, and a trial design presentation. Additionally, there are presentations of a single agent cabozantinib bladder cancer study and the just-mentioned combination phase 1b study of cabozantinib and nivolumab in genitourinary tumors. Also there will be seven presentations for Cobimetinib, including a phase 1b trial of cobimetinib in combination with vemurafenib and atezolizumab in melanoma.

And with that, I will hand the call back over to Mike.

All right. Thank you, Gisela.

In closing, we could not be more pleased with our progress thus far in 2016, and remain focused on the opportunities and significant milestones that are ahead of us.

The Exelixis team consistently demonstrates our passion, work ethic, and commitment to help patients with cancer, whether that is through further development of our compounds in areas of unmet medical need or by ensuring there are no barriers for patients who could potentially benefit from access to our medicines.

This quarter's achievements and financial results represent an important milestone for the Company, and our goal to drive the business to positive cash flow is more tangible than ever. Future financial success would give us the opportunity to invest in our business, reinvigorate our organic research efforts, as well as to potentially in-license and-or acquire compounds where appropriate. We are fully committed to this vision while maintaining a strong sense of disciplined expense management, where new R&D initiatives are aligned with robust growth in product revenues.

We look forward to updating you on our progress as we go forward. Thank you for your continued support and interest in Exelixis, and we're happy to now open the call for questions.

(Operator instructions.) Eric Schmidt, Cowen & Company.

Good afternoon, and congrats on a great start with CABOMETYX. Maybe just on a launch, PJ, it looks like if I do the math, subtracting out the inventory fill but adding back some of the sales that you got on the COMETRIQ side, the total RCC sales number's maybe somewhere in the $15 million to $20 million for the quarter. Just maybe you could confirm that. And then, too, is there any evidence that that's a bolus of any sort, or that we shouldn't expect continued growth off that figure?

Yes, Eric, thanks for the question. It's Chris. So, I guess, yes, I mean, I think you're in the right ballpark. $15 million to $20 million is about that number. And referring to the bolus, I mean, you could expect a bolus, but in our instance, since we had COMETRIQ out there previously, we don't think there's any bolus of patients waiting for product. They had the ability to be treated on COMETRIQ prior to the launch of CABOMETYX.

Okay. And then maybe for Gisela, just a couple clinical trial questions. First, has the interim analysis of the CELESTIAL HCC study occurred yet? And if not, will you let us know when you're planning, or when that might happen?

Well, Eric, what we've communicated is that the study is accruing globally, and continues to do so. We're expecting results from the study in 2017. There are two interim analyses built into the trial at 50% and 75% rate of the event. And we will inform when we have achieved such milestones. We haven't guided on the timing around [that].

So, you haven't achieved 50% of the events yet, is that correct?

We haven't guided on the timing of the interim analysis.

But, you would have told us had you achieved 50% of the events and taken the interim?

Hey, Eric, it's Mike. When we do the interim, we will be transparent about the results in some format. So, stay tuned.

Okay, thanks. And just a couple quick ones, then. Is there a timeline for when we might hear back from the FDA on the potential filing strategy around CABOSUN, and also a timeline for data from the -- I know it's not your trial, but [a CTEP] trial, the Nivo plus Cabo trial in genitourinary cancers?

Yes, this is Gisela. We have initiated a dialogue with regulatory agencies regarding the CABOSUN results, and potential paths forward towards a filing strategy and further development in the first-line setting of RCC. As soon as we have more definitive information, we will certainly make that available. At the current time, these are ongoing conversations. We are also working with the ALLIANCE to access the data, and we're expecting the full results to be presented later in the year.

And regarding the combination study, as I mentioned, the combination of cabozantinib plus nivolumab plus-minus ipilimumab is expected to be presented at the upcoming ESMO conference. So, that will be the next public occasion, if you will, for this study.

Thanks, and congrats again.

Thanks, Eric.

Stephen Willey, Stifel.

Yes, thanks for taking the questions, and congratulations on a great start. I guess one question maybe to follow up on the prior with respect to CABOSUN and regarding your characterization of what's occurring now in terms of just being in dialogue with FDA, I think you're also talking about a potential development path forward. So, just wondering if you can confirm whether or not that may or may not include a confirmatory study, or if you would perhaps think about expanding the development program to perhaps look at something like CABOMETYX against maybe Torisel within poor-risk patients specifically.

Yes. As I said earlier, we have initiated the dialogue that is around obviously the CABOSUN results. And as we achieve more results later in the year that are then also going to be public, this will be further discussed. I think in terms of the development strategy, I think it's a little bit premature to comment at this current time. We're certainly working through a number of scenarios, and I think as soon as we have arrived at a conclusion and a firm path forward, we will communicate that.

Understood. And then, just maybe with respect to some of the traction that you're seeing thus far in the market, I think Pfizer just recently reported what looked to be about a near 20% decline of INLYTA sales within the US. So, just curious if you're seeing any strength specifically in either maybe second or third-line, or does uptake between the two lines of therapy appear to be pretty equivalent at this point?

Yes, thanks for the question. With regards to second and third line, we're very pleased to be seeing strong uptake in both settings. So, we're happy with that. Additionally, I'd say we're very pleased to see uptake in adoption across physician segments, really including community oncologists, KOLs and academic oncologists, and we're also seeing significant uptake in new prescribers. 75% of those who wrote CABOMETYX last quarter were actually new to the brand in the sense that they hadn't written COMETRIQ previously. So, we're seeing a significant number of positive trends that we're really excited about.

Understood. And maybe just one final question for Gisela. Do you have any insight as to whether or not the NivoCabo data that's going to be presented later this year may also include biopsy data?

In the trial protocol, there are a number of translational endpoints built in. And we'll see at the ESMO conference whether that can be also addressed, or will also be addressed, in the presentation. At this current time, we don't have that information.

Okay. Thanks for taking the questions.

Thank you, Steve.

(Operator instructions.) Michael Schmidt, Leerink Partners.

Hey, guys, thanks for taking my questions, and also congrats to a great Cabo launch in RCC. And thanks for the details provided around some of the metrics. I had a couple of follow-ups. So, the COMETRIQ tick-up in sales, is it fair to assume that most or all of this is due to RCC demand as opposed to inventory buildup for COMETRIQ?

Yes. Hey, Michael, it's Chris. So, as PJ stated, I mean, we see the [MTC] demand being stable, so you can infer from that that the RCC demand continues to be there and support the product. We didn't see an increase in inventory that was any material amount.

Okay. And for CABOMETYX, would you expect additional inventory build in the third quarter?

We're not providing guidance on that, but, I mean, I think there's enough inventory in there that we wouldn't expect it.

Sounds good. And in terms of gross-to-net for CABOMETYX here in the launch, do you have any color on that?

So, not specifically on CABOMETYX, but overall our gross-to-net is in the 10% range, and we've actually detailed that in our 10-Q. So, that's what we estimated, and that's what we experienced in the second quarter.

Great. Thanks. And then, I noticed you have a fairly large balance of NOL carry-forwards in terms of just -- of tax, tax forecast. I'm just wondering how much of that you could potentially realize, and then when those expire.

Off the top of my head, I think they start to expire in the 2018, 2019 range, and then go out to I think the 2030 range. And the NOLs are just north of $1.3 billion. So, we can start utilizing them when we become profitable, and we'll continue to utilize them as we are profitable.

Thanks. And then, one last question. In your agreements, partnership agreements with Roche and Ipsen, are there any major change in control provisions that could be important?

Michael, this is Chris, yes. So, there's nothing that's -- there's no major change in control provisions that are important.

Great. Thanks so much, and congrats on a great launch.

Thanks, Michael.

Thanks, Michael.

Stephen Willey, Stifel.

Yes, thanks for taking the follow-up. Was just curious if you could tell us what percentage of SG&A this quarter reflects the net loss coming out of the Cotellic co-promote. And then, another question, I guess as you think about atezo and Cotellic moving through phase three and potentially securing a label in colorectal, just wondering I guess how the additional staffing in terms of co-promoting the colorectal opportunity would occur in terms of the commitment of resources on the Exelixis side. Thanks.

Yes, Steve, it's Mike. Why don't we have Chris take the first part, and I'll take the second part, okay?

So, Steve, yes, this is Chris. The Cotellic loss for the quarter was just around $3 million, and that's what's running through SG&A.

Good. In terms of future possibilities about commercializing Cotellic in other indications, certainly you've highlighted one of the key indications that was noteworthy at ASCO and generated a lot of interest, both when it was presented and afterwards in terms of the atezo-cobi combination in late-line CRC.

But, there's others, too, as well, that are moving along, so it's a very important asset to us, and one that we would like to be able to participate in, going forward, obviously. From the standpoint of how the commercial expenses and headcount would scale in the future, it's really hard to speculate on that right now, and I certainly wouldn't want to speak ahead of data and ahead of any kind of clinical and regulatory success. But, we're watching it very closely, and we're very excited about the activity that we've seen to date, and looking forward to seeing more as we go forward.

All right. I appreciate the follow-up. Thanks.

Thank you. At this time, there are no further questions, and so I will turn the call over to today's host, Susan Hubbard. Ms. Hubbard?

Thanks. Thanks, Bryan, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address on today's call.

Thank you. Ladies and gentlemen, this does conclude today's program, and you may all disconnect. Everybody have a good day.