Exelixis, Inc. (EXEL) Earnings Call Transcript & Summary

June 9, 2021

NASDAQ US Health Care Biotechnology conference_presentation 42 min

Earnings Call Speaker Segments

Chris Shibutani

analyst
#1

Hello, everyone. My name is Chris Shibutani. I'm a member of the Goldman Sachs Biotech Equity research team. Welcome to this session of the 42nd Annual Healthcare Conference. Very excited to have Exelixis join us. On the team, Dr. Michael Morrissey, CEO. Michael, thank you for joining us as well with his tremendous team of Investor Relations folks, Susan Hubbard and Varant Shirvanian, and hopefully, I didn't mispronounce this. So Mike, thank you very much for joining us. Good to see you.

Michael Morrissey

executive
#2

Thanks, Chris. Great to be here.

Chris Shibutani

analyst
#3

Excellent. So we'll have a chance to discuss all sorts of things. We're coming off of an ASCO meeting, and yet another virtual situation there. Just top of mind, how was the experience for your team this year?

Michael Morrissey

executive
#4

Yes. Well, there's pros and cons of being on the couch at ASCO. Certainly, it's pretty easy to navigate all the meetings, all the presentations, lots of great data this year, obviously. We all miss not being there, as you would imagine. The other big part of ASCO was just connecting with people and talking to investigators and customers and prescribers. So we're really excited to be hopefully coming out of COVID and moving back to a live ASCO experience in 2022. We've got great booth space next year. So we're really excited to be back there a lot, for sure.

Chris Shibutani

analyst
#5

Terrific. And to what extent has sort of the shop that Exelixis has returned towards sort of a new definition of the next normal? What portion of the footprint is now occupied in labs by your team and how your sales force is navigating? Maybe just a little commentary there on where you guys are at this stage of the game?

Michael Morrissey

executive
#6

Yes, for sure. So obviously, California has done extremely well on the vaccination front. We, as a company, have done -- I would say, we've exceeded expectations in terms of our rate of vaccinations, especially at headquarters, where we're tracking that pretty closely. We've been back in some sort of manner or form, working on sites. Certainly, the executive team and other key parts of the company going back as Q4 last year. We're slowly moving back -- the full team back to pre-pandemic levels. We had a pretty flexible approach and culture around working from home, largely due to the commute in the Bay Area and the challenges of either commuting from the East State of Peninsula where the old site was or vice versa. So culturally, that's always been a big part of our story in this flexible, empathetic, practical approach to how people work. So I think that made -- it actually made it easier for us to engage in the sheltering-in-place scenario and that order took place last March. People could transition pretty easily to their homes and feel comfortable about being able to do their jobs. And we got a lot done last year. I mean, I think it's safe to say that we exited COVID stronger as a company than when we began it back in February, March of 2020. So kudos to the team there. And now as we unwind all the complications of working from home and schools, hopefully, will be back in session in the fall and camps this summer. We're looking to have basically be back the pre-pandemic approach back after Labor Day. So I'm excited about that. The team seems to be railing behind that. So it should be good.

Chris Shibutani

analyst
#7

Perfect. No, that's exciting. Apologies, if you can hear some background music. I am actually with a backdrop here, but I'm in the Goldman, New York office. Walls are basically spit and tissue paper thin. And if somebody else's theme song is playing, that's not particularly mine.

Michael Morrissey

executive
#8

It's all good.

Chris Shibutani

analyst
#9

So let's talk about all the excitement that you've had really over the last 12 months in the renal cell opportunity, especially in 9ER, obviously tremendous data. Stepping even further back, I mean, renal cell carcinoma, talk about one of the more dynamic sort of landscapes in terms of how treatments have evolved. I mean, you could go back over periods of time and the last 5 years have been absolutely just breathtaking, right? In terms of just thinking about the different modalities that have demonstrated step change improvements in data. Combinations is always clearly the way that we're going to have to approach these things. And based upon the data that you guys have had from 9ER, you demonstrated that the TKI combination with the checkpoint inhibitor that you had an offering that was extremely competitive there. So I think we saw some impact from that, really 12 months now, top line, further data, and it seems to have really resonated with the physicians. Talk to us about where things are at now, probably a year since the topline data, but there were a couple of milestone events, whether it's incorporation into NCCN, presentation of full data, where along this arc of like letting people know about 9ER, do you think we are?

Michael Morrissey

executive
#10

Yes. So it's really been fascinating and I would just take a step back. I was -- my first ASCO, gosh, back in the early 2000s or so is when the sorafenib data, the Phase II data for sorafenib came out, right? I remember sitting in that very small conference room watching that data being presented, thinking, wow, this is awesome. And now you fast forward 15 years, and you see just the incredible progress that the pharmaceutical and the biopharma community has made in terms of moving the needle for patients. It's just been tremendous. Look, we're thrilled with the 9ER data and the collaboration we have with BMS to be able to move that forward. We made some -- I think, some really important strategic choices early on. I think starting with the optimized 40-milligram starting dose that we did with 9ER and then being able to pass that forward with all the other ICI combinations that we're doing with cabo. I think we will get the right move. When you think about keeping patients on therapy on the combination for potentially years, you want to make sure that their experience from a quality of life point of view is as good as possible. And taking a little bit off the top of an efficacy point of view, but really gaining so much on the quality of life point of view and the keeping patients on drug, a low discount rate, all those things really have played well for us in terms of how we can position the data relative to a number of competitive offerings. So we're thrilled with that. We have great data. We have a great team. The RCC commercial organization at Exelixis has really had a leading share of voice since we launched METEOR back in 2016 around RCC. So to be able to take that depth of knowledge, and just put this new data on top that's got great efficacy, safety, tolerability and quality of life depth. It really resonates well with customers, resonates well in the field and certainly, with all the market research that we've done. So it's 1 more step forward. Obviously, we have the triplet going with 313. We've got the cabo/atezo combo in second-line post IO as well with Roche and Genentech. So we are heavily investing in RCC with the goal that we have for all indications in all kinds, and that is to raise the bar for standard of care. That's what we do day in and day out is to make -- try and make better -- generate better data for patients that will benefit them and then allow us to move the needle for patients and for shareholders.

Chris Shibutani

analyst
#11

And remind us when some of the timelines that people should have just that we're level set as of today where the next incremental goal points are going to come for these additional renal cell applications?

Michael Morrissey

executive
#12

Yes. So 313 is fully enrolled and it's all event based. So we see that end of this year, early next year. It's hard to say based upon where we're at with events right now, it's still pretty early. CONTACT-03 is still enrolling. Roche is enrolling CONTACT-01. Again, cabo/atezo in non-small cell lung cancer as well as CONTACT-03. So it's great to have a global powerhouse doing some of the heavy lifting there, especially in areas where they have a lot of expertise and while we focus on prostate. So -- but great collaboration. Certainly, hope to do more with them, have a strong interaction with them in 092 as well. And I think just wide open for us in terms of how we collaborate there going forward. So very exciting.

Chris Shibutani

analyst
#13

The quality of life metric, I think physicians and clinicians are accustomed to recognizing that there's some skill factor involved with managing patients through the TKIs and combinations there. Typically, obviously, the Street looking to demonstrate efficacy and overall -- we're very used to the efficacy metrics there. Can you talk a little bit about how the physicians are responding or paying attention to those quality of life metrics? I think we're seeing more and more data, especially with the combination regimens for first-line setting.

Michael Morrissey

executive
#14

Yes. Yes. And that's -- again, it's a super critical parameter when you're trying to move heavily into the community, number one, and you're trying to keep patients on drug for 12, 18, 24-plus months. I think that's the critical component. Is the quality of life high relative to keeping their disease in check, too. Those 2 things go hand-in-hand, patient wins both ways. So yes, I think the understanding and the appreciation for the different vehicles that are used in these patient-reported outcomes is growing with time. Certainly, in the renal space, there's some standard metrics that are used, have been used historically for a variety of these trials, both combinations and single agent trials to be able to qualify that. So again, we're very pleased to be able to show that we've got what appears to be superior quality of life relative to sunitinib. That's not always the case in these combination trials. But it really plays well with the idea that we can provide an option to physicians and their patients that has stellar efficacy data with the opportunity for improved quality of life over that standard agent.

Chris Shibutani

analyst
#15

So year-to-date, but I think also at ASCO, you had some incremental data or there were some studies that were being done. Correct me if I'm wrong, I might have been investigator-sponsored multicenter on tabulary renal cell, non clear cell distinct indication. I think tabulary is about 15% of RCC. We showed some data combination with nivo. It looks like the response rates were considerably stronger than certainly actually the nivo alone. And so it arguably leaves someone to question sort of what is the checkpoint inhibitor contributing to the combination there. But can you talk about sort of what the path could be for that opportunity? Is that something where we could see a multi-journey NCCN compendia listing?

Michael Morrissey

executive
#16

Sure. Well, again, we -- our current label, and this is true for single-agent cabo off media, but as well with 9ER, is a very broad kind of all-encompassing kidney cancer label. So those patients are already included. So it's really raising the awareness of the activity, whether it's the data we had, the SWOG data we had at ASCO GU or the new update data from MSKCC with the cabo/nivo combination. But it's really -- it's a relatively understudied, underserved population, but super important from the standpoint of what those patients need. So again, cabo appears to show superiority over other standard agents in that subtype of kidney cancer, and certainly, the MSKCC data with the cabo/nivo combination was, I think, very encouraging from the standpoint of response rate, PFS, OS, all the caveats of it being a single-arm study, but really highlights the activity there. That, again, isn't all that surprising relative to the 9ER data, but nonetheless, it's great to see and certainly will be useful for us to -- at the appropriate time, talk to physicians about to soon.

Chris Shibutani

analyst
#17

Right. Well into quite a generation of time where the immuno-oncology based treatments have been involved. And I would say, probably, one of the current waves is looking at the adjuvant setting, right? And I think we're starting to see some early work that's been done there, whether it was at ASCO GU or this year's ASCO. Looking at the adjuvant setting, some preliminary data, which is interesting. I think there was an Opdivo monotherapy trial, which showed some data. Talk to what you think might be the impact of the knock-on effect potentially on first-line treatment setting of adjuvant?

Michael Morrissey

executive
#18

Yes. Certainly, the pembro data that [ Tony Troy ] talked about at the preliminary on Sunday was quite impressive. It's great to see the established kind of mature DFS data looks so promising relative to not only the control arm, but also just past the adjuvant studies with sunitinib and axitinib, some of the first generation TKIs, which didn't do quite as well. The survival signal is early. It's just way -- it's encouraging and there's a lot of debate about that relative to what it means relative to the small number of events that were driving the separation between the 2 arms, but we'll see. I think it -- it's the right place to go. It's the natural evolution that you see across different oncology indications and histology. So we're certainly excited to be able to play there ourselves, asking the question, now how do you build on top of that success with potential combos as we go forward. But it's certainly, I think the expected evolution here is kind of going per plan. The impact on front line, again, we'll see -- I think the question is early adoption and how long you actually have to wait until the curve separates. So what's the impact on patient flow years out. So -- but it's great for patients, and certainly, put the stake in the ground relative to how we hope to operate and maneuver with 092, for example, if not other agents going forward. So for sure.

Chris Shibutani

analyst
#19

Right. And if we also think about further down the line, whether it's in the coming 12 months or even further out, we've already talked about how dynamic and changing the treatment paradigms have been. There's some competitive data coming, the CLEAR study that will come up with lenvatinib. And care to take a stab at sort of what the team will be addressed with in terms of -- and you faced this before in competitive dynamics, shifting dynamics, particularly when you think about the next couple of years, with similar combination regimens. How do you prepare your team to address that and to sort of interface with physicians to keep...

Michael Morrissey

executive
#20

Yes. Well, yes, it's kind of table stakes entry here relative to oncology is the most heavily invested in therapeutic area. It's the most competitive therapeutic area in terms of what biopharma is doing for the last several years. So no surprise. Statement of the obvious is that any indication that we find interesting, it's guaranteed that others usually bigger concerns, we'll do that as well. So we've been very effective at that competitive dynamic. And I think it's because we have the ability to generate differentiating data. And then we built a team, whether it be in development, regulatory and commercial that allows us to go toe to toe with anybody in size, in experience, depth and certainly, energy and passion. So it's to be expected. We expect that. We understand that going into these -- early on into these trials, and we understand what success is required to be competitive there. But it's -- I'm just super impressed. You think about renal, a small company like us, you go back 2015, 2016, after we had the topline data, we were similarly dismissed of being able to compete there. And I think it's a combination of the right data, the right team and this kind of supercharged approach to making sure that we can get the word out and we put patients first to make sure prescribers understand the value that we bring to their patients. And it's played out pretty well. So I'm expecting that, again, it have to have data and then that data drive the next steps. But I think we're very, very facile at being able to compete here day-to-day, hour-to-hour across any indication that presents itself for sure.

Chris Shibutani

analyst
#21

Yes. No, certainly, a very strong track record. Let's transition to the prostate cancer opportunity. So there was some data came in, just a hair earlier than we would have expected that update from that Cohort 6 data. Talk to us about the kinds of discussions you've been having with investors in terms of thinking about that response rate, and what you think -- how you would position the next steps for this indication?

Michael Morrissey

executive
#22

Yes. So Cohort 6 of COSMIC-021 is the metastatic CRPC population that we've been talking about for the last few years now. Again, it's a unique population. All the patients in that Cohort have measurable disease by RECIST 1.1. So -- and that's rare. You might normally see 25, plus or minus, percent in a large global trial with patients with measurable disease. We enriched for visceral disease, again, which is obviously a negative prognostic factor for disease burden, survival, all those kinds of things as well as extra pelvic lymph node metastases. And all the patients who came on that trial were actually progressing at screening. So it's a pretty late line, pretty advanced population in terms of their disease burden, the locations of their metastases and what this means for their overall prognosis. That being said, we've seen, I think, really encouraging data. The investigator response rate was 27% and the full cohort of high-risk patients, 101 patients, the BIRC determined response rate was 18%. So some erosion there, which isn't all that surprising, somewhat expected. I would say, importantly, the disease control rate, DCR, was similar for both in the 85%, plus or minus, percent range as was duration of response and PFS. So the totality of the data, I think, looks very encouraging, and we'll get that out sometime later this year along with other important metrics for the trial. In the context of looking at the control arm for PROfound, which was second NHT for ambassador 250, which is a second NHT even in the VISION trial that came out this week at ASCO, looking at standard of care with the second NHT mainly. There, you would expect to see response rates in the 4%, 5%, plus or minus, percentage range. So -- and the data that we've got out in terms of the DCR and some of the data that's not published yet in terms of other readouts, I think, looks really encouraging. So data is what it is. We're still very interested in pursuing the Subpart H filing. Obviously, we plan to talk to the FDA about that. And if there's alignment on that approach then we're taking all the steps right now to be able to file that. So -- but the first step is to actually talk to the agency, talk about the data, get their view on that and then go from there.

Chris Shibutani

analyst
#23

How have engagements and interactions with the FDA been? It's been interesting to see process, decisions, so much has changed over the last 12 months. Just curious, well-established company like yours with a molecule that obviously has tremendous track record from a safety standpoint, which we would always think as being the primacy of what the FDA is concerned with. But with these indications, just any color in terms of what the nature of the interactions have been?

Michael Morrissey

executive
#24

Yes. Look, I wouldn't want to speak directly about our conversations with the agency. We have a very strong relationship with them in multiple approvals for the cabo label. So obviously, we know how to navigate that relationship and belief value of that collaboration. They've had a very busy week this week, both, I would say, outside of oncology. So we've all seen that drama. Needless to say, we're going to pursue those discussions with -- in earnest, and do the appropriate background work and have those discussions. And obviously, we're going to have a meaningful discussion and seek alignment if that's there. So stay tuned.

Chris Shibutani

analyst
#25

Okay. Like a veteran executive that you are, that was an excellent answer. Susan and Varant are like high fiving you virtually now.

Michael Morrissey

executive
#26

Yes, I'm going to get the hook if I don't, right? So there you go.

Chris Shibutani

analyst
#27

Exactly. No, I had to ask. So prostate has always been such a difficult indication. It's kind of definitely not a hot tumor. So thinking about that opportunity, in my recollection historically almost a decade ago, that was one of the initial indications that you guys went after. So is there some view that there's some segment of the patients that you think, is patient selection somehow could be the right way to thread the needle to optimize the opportunity?

Michael Morrissey

executive
#28

Well, I think in this case, yes. Certainly, we learned a lot from the trauma and drama of the COMETs. So going from 2012 through 2014 with the COMETs where the bone scan response and all that really interesting pharmacology, in some ways, convoluted the topic of cabo's impact on prostate cancer. We learned a lot since then, right? We certainly picked a better tool to assess response, i.e., RECIST 1.1 in measurable tumors, right, which looks at a bone scan for progression, but doesn't rely upon that for efficacy, right? So we've covered our bases there with RECIST 1.1, looking at -- and it's actually a pretty large segment when you think about the number of men that have prostate cancer -- metastatic prostate cancer and you kind of back calculate how many have measurable disease. It's still a sizable portion. So it's not a micro niche population. It's a sizable portion of patients. Met in the context of all the NHTs moving up now to the castration-sensitive population to the M0 population really has left a void for agents that can benefit these patients when they invariably progress, right? So chemo is always an option, but if you're an 80-plus year old man who's been through surgery, radiation, years of ADT, one or more of these NHTs maybe chemo when you had castration-sensitive disease. I mean it's not surprising that a lot of men pass on that, right? And in our experience with Cohort 6, about half of the -- half the men in that trial actually had 2 NHTs. So they understand what's in for them when docetaxel is at disposal. So that, coupled with the fact that now cabo has been in the market for 5-plus years, the understanding of how to utilize that drug, which wasn't there back in 2012, 2013. Your average GU oncologist that's focused on prostate really has never seen a TKI before. So the whole idea of dose adjusting and working around some of the fatigue issues at what was probably a too high of a dose anyway when dosing was certainly a complication. So we learned a lot. We've narrowed the population. We have big ambitions for prostate, obviously because of these -- the impact of cabo-like molecules on the bone. And we can envision a whole separate program with 092 going forward as we build out that effort. But we're thrilled with both the data from Cohort 6 and certainly having CONTACT-02 up and running globally now. Again, you look at the metrics that we talk about in the fall relative to the control arms from those other trials we talked about, we're feeling pretty good right now about the overall approach. So it's got to keep turning the crank and getting this stuff done, right?

Chris Shibutani

analyst
#29

Yes. And we'll turn to 092 and to CONTACT as well. But before we get there, the next near-term catalyst, I believe, is in HCC, hepatocellular, looking at some data there, which I believe the time line guidance is still for 2Q, which I think still has 20-plus calendar days to it, but we're still in 2Q. Are we still on....

Michael Morrissey

executive
#30

That is -- you are correct on all 3 accounts. It's still looking like Q2. And obviously, once you hit the events, which is always the big -- kind of the big white knuckle in terms of watching these things tick in, then the process is fairly regimented in terms of how you go from your event number to topline results. So we're on that path right now and fully expect to have that this quarter, this month. And you're right about the calendar, calendar is calendar. So -- but we're excited about that. It's always the most kind of interesting time in this chair. When you go into a room and meet with people and they club the envelope, it's like the Academy Awards, right? So it's always fun. But it's certainly the success from 9ER. We don't deliver great different, obviously, but in some ways, a lot of the same issues are at play here with IMbrave reading out earlier. Survival is really necessary to have a competitive offering. The trial between -- trial designs and populations between IMbrave, which was cabo/atezo versus 312, which is -- cabo/atezo are really very similar. Their only difference is basically switching out cabo for bev. I certainly like that switch in terms of what will cabo offers in terms of its profile, both as a really potent anti-angiogenic antitumor molecule #1, but also in the liver with the celestial data with overall survival, I think really puts a stake in the ground for us. So yes, so we're -- again, we're excited about that. We have the goal. The most important goal for the company this year is to have 3 potential sNDA filings for DTC, which was filed recently, and we had that announcement on Monday when the ASCO presentation was made. Prostate, if we have alignment with the agency based upon the Cohort 6 data and then certainly 312, that's positive. So everybody is raring to go and aligning around making sure we get that done this year.

Chris Shibutani

analyst
#31

Got it. And you really run right away the comparison that people will inevitably be making and to understand how to refer to think about that data with competitive stuff with IMbrave. The contact studies include data, I believe, Phase III data that we could see in other indications, including readout. And correct me if I'm wrong, but I believe timeframes for that are kind of the 2022, '23. Give us an update on where we are with that, and how we should be thinking about those readouts?

Michael Morrissey

executive
#32

Yes. So it's a bit early. It wouldn't surprise me if those come in '22, again, without giving any kind of precise guidance there. I mean, they're all 3 contacts, lung for CONTACT-01, prostate for CONTACT-02 and second-line renal for CONTACT-03, all with cabo/atezo combination. They're all enrolling. Obviously, they're all event based. So it's the complication of the enrollment rates, which are going pretty well along with the generation of events, whether it be PFS or OS, depending on the trial. So but again, thrilled to be working with Roche, Genentech on this. It's right across the bay here from Alameda. It has been a great collaboration with them, and we're very, very excited about the opportunity across the board. We're investing heavily, obviously, in renal, which makes sense. Prostate, we have a long-term interest in. And in lung, we've had a lot of cabo data, whether by itself or in combination wild-type population, different activating mutations like RET population. So long historical interest in cabo in non-small cell lung cancer, which we think -- again, this is a great first step for the franchise, and certainly, a lot more interest and potential activities with 092 as we go forward there as well.

Chris Shibutani

analyst
#33

Got it. I wanted to touch base with you on the exclusivity. There's obviously a generic company challenge currently. Can you remind us what events are upcoming in terms of when there'll be sort of progress, any of these legal processes typically drag on? But if so, can you remind it?

Michael Morrissey

executive
#34

Yes. So we're past the markman, which is a non-event since there wasn't a need for claims adjustment. So next big milestone is the trial that is on the books for mid-2022.

Chris Shibutani

analyst
#35

Staying mid-'22? Okay. So since then, there's -- in between now and then, there's really nothing to add?

Michael Morrissey

executive
#36

Yes. Yes.

Chris Shibutani

analyst
#37

Were you a little bit surprised by the Teva ANDA filings in terms of the patents that they went with Round 1?

Michael Morrissey

executive
#38

Nothing surprises me anymore. Yes, I don't want to say too much about that, per se, just -- again, I don't want to litigate this or point upon this publicly too much. It's just a dangerous move to make, but pretty clear what they're challenging. And I think it's interesting for sure. So I'll let you point upon that yourself for sure.

Chris Shibutani

analyst
#39

Okay. I would pass. So cabo has been such a successful, and it's such a competitive and difficult realm, and you guys have been so robust with the efforts that you've moved into it. And mostly typically, myself included is always like, but what have you done for me lately? And what's coming up next, et cetera. So if we could talk about the pipeline and sort of before we even go to like 092, how are you feeling about sort of the breadth and the depth and what you have in the pipeline? I feel that 092 is very much core competency driven and very much involve with what your labs have been very amongst the leaders at. Some of the business development news that you've progressed towards recently has included more ADC activity. How are you feeling about the current complement that sitting on the bookshelf and where that's at? Is it where you want it to be?

Michael Morrissey

executive
#40

Yes. So again, from a standing start back in 20 -- late 2016, early 2017, I think we've certainly exceeded expectations in rebuilding our discovery efforts, which were arguably extremely strong back in the day in the 2002 through 2010 realm where we heavily, heavily invested. But we didn't have a really sustainable business in terms of free cash flow and revenues to keep that going, right? So yes, it's been -- again, focusing on cabo was never a strategy, it was simply a tactic to get the business to a point where we could have generate -- have the ability to generate cash, if we were successful with cabo as we have been. But then reinvest back in the business and build this diversified pipeline of assets and clinical candidates and now clinical molecules going forward. So yes, I'm thrilled with what we've done. We're adding in a network of discovery in terms of internal efforts, external efforts, we're adding people. We're adding buildings. We're adding a network. We're adding to our network of collaborators virtually every quarter and feeling really good about that. I like the idea of further diversifying across modalities. With the same theme that when we go into an area, we go in heavy. We're not -- we're going to muscle up. We're not going to dabble and do a little bit here and a little bit there. I mean, I think that's a recipe for failure and just disappointment. So we're going into ADC strong for a variety of reasons. And I feel good about that from the standpoint of building novel binders, having an a la carte approach to next-gen, if not best-in-class, linker warheads. And having the ability to put those together and then play into our strength of doing early development quickly in a very focused fashion with the idea that every molecule we advance into the clinic has a fast path to market. So there's a built-in approach to be -- if we see a sensitive tumor type, and we like that activity to be able to play the COSMIC-021 game over and over again to be able to expand, enhance, understand and then be able to file off that, if appropriate. So the team is super excited. We've had tremendous growth in discovery and development and the whole company during COVID, which is somewhat, I would say, a counterintuitive, but we've added about 300 new employees over the last 12, 13 months. So that's been tremendous. We're building. You can see our new headquarters right there, which will give us more space to grow in terms of lab space. So we're all in, and we're all in because we've got a growing revenue base and cash flows to be able to fund it all, right? So it's the idea of making money and then investing in the business that can drive future growth. So we don't get a lot of credit for that right now, but that will come with data and clinical progress. So we're certainly patient in -- I would say, realistic in that regard, for sure.

Chris Shibutani

analyst
#41

So the R&D guidance for spending was a range of $600 million to $650 million. This implies roughly a 10% to almost 20% year-on-year growth rate. Should we anticipate that this is kind of the level of spending growth cadence over the next few years? Is there that level of urgency? Or can you comment on that?

Michael Morrissey

executive
#42

Yes, I wouldn't want to give explicit guidance on what to expect beyond '21. But as far back as 2015, when we did our last financing post the METEOR data, what we said was, our goal was to build the company in a way that we could generate revenue on a growth trajectory and then spend more based upon that growing revenue base. And I think we've behaved exactly in that line for the last 6 years and that will continue going forward. We're not going to be able to bring up new molecules, new combinations, raise the bar on standard of care, if we don't spend that money, right? So it's just -- it's a high investment, high-reward situation. And obviously, cabo is a pretty good example of that, where it took us a while to figure it out and our bad for not making it go faster, but we did that. And it's helping literally tens of thousands of patients every day, and we think we can do that again and again and again. So that's the goal.

Chris Shibutani

analyst
#43

And with 092, perhaps, that being advanced clinically from a development standpoint, what's the timeline that we'll learn in the next sort of layer of approach? And learn some data there because I think you've talked previously about figuring out how to navigate, how to position 092, so it capitalizes on its benefits, but then also potentially reduces some of the potential for cannibalization where cabo already has a footprint. Can you....

Michael Morrissey

executive
#44

Yes. Yes. Yes. So I would say, at a high level, you'll see new ICI combination collaborations. You'll see us start the first wave of pivotal trials, and then you'll see more data in the coming timeframe. I don't want to commit to anything hard and fast in terms of timelines for that, but we're investing a lot here. We're looking to expand the reach of 092. There's so much that we know about cabo that we haven't followed up on in terms of tumor types outside of RCC, HCC, prostate, thyroid, for example. And even in those areas, again, we're not looking to compete head-to-head with cabo, but there's so many different ways to play that in terms of lines of therapy, combination partners, et cetera that it's a wide open playing field. But we've got bonafide single agent activity with cabo in 20 different tumor types, and we call it up on a fraction of those. So we've got time. We've got arguably a better molecule, and we have significant cash flows to fund that operation. So this is kind of hitting in our sweet spot. We know what we're doing here. We've done that before. This is just part of the cabo franchise expansion. And then we're certainly going to invest heavily in new molecules, new modalities, single agent combinations as we go forward. So the aspiration is to be a multi-product company with outsized revenues and helping patients on a scale that's logarithmic, not linear, okay.

Chris Shibutani

analyst
#45

On that multiproduct front, you have such a well-established, well-trained smart sales force, who knows the oncology target points there. SG&A spending, the range, the midpoint is about $400 million for this year on the SG&A spend. You talk about being a multiproduct company. Is part of that potentially to contemplate possibly acquiring any commercial assets to kind of leverage that experienced sales force? I think we closed last quarter with just north of $1.5 billion. Any shopping interest?

Michael Morrissey

executive
#46

Yes. So we're always shopping. We're always talking. We're always looking. The key feature on commercial assets is growth potential, us buying a static revenue stream. It doesn't make a lot of sense, especially if they're older MOAs that are going to be attack with newer approaches in the short term. So we're very interested. As you know, Chris, we've done a lot of these early-stage, back-end loaded deals for preclinical assets. Some of them have now moved or we have 2 in the clinic now from that. So that's been a very effective way to spend our money within a very disciplined fashion. We are looking, and we continue to look for later-stage assets clinical, early clinical, late clinical, potentially commercial. But all that has to make sense relative to the value that we see, the commercial opportunity, the competitive situation and the overall risk profile. So we're very accommodating the risk, but most important thing for me is to have the conviction that if you can generate competitive data, can we actually then monetize that and make the ROI makes sense for us in terms of how we go forward. And that -- with the assets out there right now and with I think some of the challenges working in these micro or nano niche populations where compounds are printing $5 million a quarter, $10 million a quarter, I just don't see the value of doing -- going down in that direction. And we put a stake in the ground there not to do that 5, 6 years ago because of that whole issue of how do you commercialize that in a way that makes sense from an ROI point of view. So stay tuned. Obviously, we'll do what makes sense. And I think we've got a very strong team that can analyze the situation across really every component, R&D, commercial, financial, et cetera. So it's -- for us, it's a very clear regimented data-driven process that I'm really happy with because it's not just a BD guy in some office thinking about ideas, but it's the whole team across disciplines, making this stuff happen. So...

Chris Shibutani

analyst
#47

Okay. Glad to hear it's not some BD guys sitting in an office. Speaking of some guys sitting in an office of the Board, just can you comment about how you feel about -- you've been in your position for quite a while. The company is quite established. And with the Board, I noticed that the tenure -- the average tenure has been quite a few years. Do you take a look at that? Or do you feel as if that there's any opportunity for fresh voices or reshaping at all?

Michael Morrissey

executive
#48

So we have a great Board. They've been with us together between the management team and the Board for years and years and years and completely aligned in the good times and the bad times, both strategically and tactically. So I have to say, it's -- as a resource for me and the management team, our Board with their perspective, their backgrounds, and it was really built -- the Board was built by Stelios Papadopoulos and his vision for what it takes to have a team that can function as a Board, but then interact with management in a way that is just extremely enabling. So it's a great group, and I hope they continue to be as impactful as they have been. We have a lot of challenges ahead of us, but I am very, very pleased and excited about that relationship between me and them, and the management team and them and their support over the years. So we wouldn't be here today if they hadn't been so supportive. And so really encouraging in terms of pivoting and navigating some of the challenges that we've had previously.

Chris Shibutani

analyst
#49

Okay. Terrific. Mike, thank you so much for joining us. I appreciate this opportunity to chat with you and get an overview, especially as your team is coming off of an exhausting ASCO. Thank you also as well to Susan and Varant, your outstanding Investor Relations group. So thank you, everyone.

Michael Morrissey

executive
#50

Thanks, Chris. Cheers.

Chris Shibutani

analyst
#51

Thanks, Mike. Take care.

Michael Morrissey

executive
#52

Bye.

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