O-I Glass Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2023

There are 18 speakers on the call.

Operator

Day, ladies and gentlemen, and welcome to the Exeliqus First Quarter 2023 Financial Results Conference Call. My name is Towanda, and I'll 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, Executive Vice President of Public Affairs and Investor Relations, you may proceed.

Speaker 1

Thank you, Towanda, and thank you all for joining us for the Exelixis Q1 2023 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO Chris Senner, our Chief Financial Officer TJ Haley, our Executive Vice President of Commercial Dana Aftab, our Chief Scientific Officer and Vicki Goodman, our Chief Medical Officer, who will review our progress for the Q1 2023 ended March 31, 2023. During the call today, we will refer to financial measures not calculated according Generally Accepted Accounting Principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non GAAP measures, as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward looking statements regarding future events the future performance of the company.

Speaker 1

This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters. Actual events and results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC, Under the heading Risk Factors identify important features and factors that could cause actual results to differ materially from those by the company verbally and in writing today, including without limitation, risks and uncertainties related to product commercial success, Market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, Our dependence on collaboration partners and the level of costs associated with discovery, product development, business development and commercialization activities. And with that, I will turn the call over to Mike.

Speaker 2

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a strong first quarter across all components of our business. CABOMETYX maintained its status as the leading TKI for RCC in both the first line IOTKI market and the second line monotherapy segments. We're advancing our discovery and development priorities to build the Exelixis product portfolio in a disciplined and thoughtful manner.

Speaker 2

I know it's a statement of the obvious, but I want to repeat it here. We're in the R and D business. The only way we drive growth for Shareholders is to improve standard of care for patients with cancer. It's impossible to disconnect the 2. The more patients we help, the more value we create.

Speaker 2

Our singular focus in R and D is to advance the pipeline of clinically and commercially differentiated medicines For large populations of cancer patients with high unmet medical need. We estimate CABOMETYX is used by tens of thousands of patients annually and we seek to help many multiples of that number with the pipeline we're building today. Our success with combo isn't the end game, it's just the beginning. We are biology centric and modality agnostic Biologics and small molecules within a neuro therapeutic framework in oncology. We're disciplined in our integrated strategy spanning discovery, Development and commercial and focus on advancing drugs that will move the needle for cancer patients in meaningful indications to build value for shareholders.

Speaker 2

Molecules that look only modestly interesting or aren't compelling from a commercial perspective never make it out of the gate. Our R and D strategy includes targets and compounds we advance and as important those we exclude and overtly choose not to pursue For scientific, clinical, competitive and commercial reasons. The success of our integrated strategy bridging R and D with commercial Relative to our midsized biotech peers is highlighted by the historical data on biotech oncology launches since 2016. Of approximately 35 launches in this timeframe with drugs addressing many of the hottest targets in oncology, the mean and median 2022 global net product revenues were approximately $200,000,000 and approximately $150,000,000 respectively, Compared with the 2022 global net product revenue number for CABOMETYX of $1,900,000,000 We pick the winner while avoiding less productive avenues in the past and have the insights and discipline to do so repeatedly in the future. With that, please see our press release issued an hour ago for our Q1 financial results and an extensive list of key corporate milestones achieved in the quarter.

Speaker 2

And I'll now turn the call over to Chris.

Speaker 3

Thanks, Mike. For the Q1 of 2023, the company reported total revenues of approximately $409,000,000 Which included CABOZANTINAR franchise net product revenues of $363,400,000 CABOMETYX net product revenues $361,800,000 and included approximately $19,000,000 in clinical trial sales. Gross to net for The cabozantinib franchise in the Q1 of 2023 was 30.3%, which is higher than the gross to net we experienced in the Q4 of 2022, but overall in line with our expectations. This increase in gross to net deductions in the Q1 of 2023 primarily related to higher Medicare Part D and PHS expenses. Historically, we have experienced higher Medicare Part D expenses in the Q1 of the year due to many Part D patients moving to the donor hole at the start of the calendar year.

Speaker 3

Our CABOMETYX trade inventory decreased by approximately 900 units when compared to the Q4 2022 to approximately 2.1 weeks on hand. As I mentioned on our Q4 earnings conference call, we experienced a trade inventory build in the Q4 2022 approximately 750 units As well as we observed most of that Q4 trade inventory build drawn down the 1st 2 weeks of 2023. Total revenues also included approximately $45,000,000 in collaboration revenues including approximately $33,000,000 of royalties earned from Ipsen and Takeda on their sales of cabozantinib. As a reminder, clinical trial sales have historically been choppy between quarters and we expect this to continue in future quarters. Our total operating expenses for the Q1 of 2023 were approximately $380,000,000 compared to $472,000,000 in the Q4 of 2022.

Speaker 3

The decrease in total operating expenses sequentially was primarily driven by lower R and D expense in the Q1 of 2023. Provision for income taxes for the Q1 of 2023 was approximately $8,300,000 compared to a benefit for income taxes of approximately $1,300,000 for the Q4 of 2022. Company reported GAAP net income of approximately $40,000,000 or $0.12 per share on a fully diluted basis for the Q1 of 2023. The company also reported non GAAP net income of approximately $52,800,000 or $0.16 per share on a fully diluted basis. Non GAAP net income excludes the impact of approximately $13,000,000 of stock based compensation expense net of the related income tax effect.

Speaker 3

Cash and investments for the quarter ended March 31, 2023 was approximately $2,100,000,000 This level of cash and investments supported by our ongoing cash flow from operations It provides Exelixis with the flexibility to invest in internal discovery activities to pursue external business development opportunities to expand our pipeline And allows us to return capital to our shareholders through the $550,000,000 share repurchase program we announced in March of this year. Finally, we are reiterating our full year 2023 financial guidance, which is detailed on Slide 14 of our earnings presentation. I'll now turn the call over to PJ.

Speaker 4

Thank you, Chris. The Q1 of 2023 was a strong quarter for cabozantinib. Team continues to execute at a high level, Which has resulted in CABOMETYX continuing to be the number one prescribed TKI in RCC and second line HCC. Importantly, CABOMETYX in combination with nivolumab is the number one TKI plus IO combination In first line renal cell carcinoma. Furthermore, the CheckMate 9ER 44 month long term follow-up data Presented at ASCO GU is resonating with prescribers and strengthening the position of CABOMETYX plus nivolumab In first line RCC, physicians find the 49.5 month median Overall survival of CABOMETYX plus nivolumab to be compelling.

Speaker 4

In terms of the business, CABOMETYX TRx volume grew 12% Year over year in Q1 2023 relative to Q1 2022. Looking at the TKI market basket of CABOMETYX, Inlyta, Sutent, Votrient and LENVIMA, TRx volume in Q1 2023 was stable Relative to Q4 2022, TRx volume for CABOMETYX was also stable in this time period. Additionally, new patient starts and demand remained strong in the Q1. CABOMETYX continued to perform well in Q1 from both a marketplace and competitive perspective. CABOMETYX again led the TKI market basket in TRx share at 39%.

Speaker 4

As we have discussed previously, the first line RCC market is extremely competitive and we are pleased with the performance of CABOMETYX in combination With nivolumab in this setting. Q1 was the 2nd full quarter in which CABOMETYX plus nivolumab Was the number one prescribed TKI plus IO combination in first line RCC. Update in the first line RCC setting is broad across clinical risk groups and practice settings. Importantly, prescriber experience to date continues to be positive and physicians report that it is consistent With the balance of efficacy, safety and quality of life seen in the CheckMate 9ER data. Long term 44 month follow-up data from the 9ER study was presented at ASCO GU in February.

Speaker 4

The median overall survival for the CABOMETYX plus nivolumab arm is 49.5 months, representing an improvement Of 14 months over the comparator arm sunitinib. These data are compelling to prescribers and are viewed as clinically meaningful And the feedback on the data has been extremely positive. Furthermore, physicians believe that the data support their experience Using the combination in terms of efficacy, safety, tolerability and quality of life. Prescribers believe that this balance of data and low discontinuation rate of CABOMETYX plus nivolumab Enable patients to stay on therapy longer to achieve these results. We are pleased with the positive prescriber feedback On the 44 month 9ER data, these data reinforce the leadership position that CABOMETYX has in the marketplace We believe these data position CABOMETYX Our entire team works every day to ensure appropriate patients have the opportunity to benefit from cabo.

Speaker 4

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

Speaker 5

All right. Thanks, PJ. Okay. So Peter Lam has discussed the pipeline in-depth Number of times previously. So I'm not going to reiterate that today, but instead I'll touch on some of the key features that underlie the pipeline.

Speaker 5

Our overall strategy is designed to reduce target biology risk in a number of ways. First, we're not dependent on one mechanism of action Or limiting our approach to a single aspect of tumor biology for pipeline success. Instead, we're prioritizing targets based on the strength of the science And their ability to address the complexity of tumor biology. 2nd, we are not limiting our modality to small molecules. We've now fully enabled both small molecule and biotherapeutics capabilities for our internal discovery efforts.

Speaker 5

Our small molecule discovery programs are focused We are currently on synthetic lethal targets with clear patient selection strategies and our biotherapeutics programs are focused on antibody drug conjugates For bispecifics and monoclonals focused primarily on innate immunity. Our clinical and preclinical pipeline takes a best in class approach That's informed by prior clinical data or proof of concept from earlier programs. This in our view greatly reduces target risk. So here's the pipeline beyond cabozantinib. The 2 most advanced programs are zamolitinib and XB-two.

Speaker 5

Vicki will be discussing these programs in much greater detail, so I'll only summarize the underlying strategies for them here. Both of these programs are built on prior clinical experience with molecules that have the same target profile. XANZZA obviously builds on our experience with cabozantinib. The target profile is essentially the same, but the pharmacokinetics have been optimized. The aim here is to have an easier to manage and potentially more combinable drug to allow us to explore the clinical white space where we have evidence that cabo is active But where we have not pursued registrational trial and to also explore novel combinations in areas where cabo is already approved.

Speaker 5

XB-two is our tissue factor targeting ADC that builds on the known profile of tislelizumab vedozum or TIVDAC, Which is approved for cervical cancer. XB-two combines a novel monoclonal antibody against tissue factor With the next generation linker payload technology that together result in a molecule with reduced risk of bleeding and increased stability of the intact ADC. The next programs I'd like to highlight are our 2 option agreements With our programs with Zybrexa and Zyropha. These option type arrangements are capital efficient way to access clinical stage assets With the back end loaded structure where we pay for success. The Fibrexa agreement gives us an option on a novel peptide drug conjugate Currently in Phase 1.

Speaker 5

DDX-twelve is a pH sensitive peptide conjugated to exotecan, a topoisomerase 1 inhibitor. This novel mechanism of action designed to enhance the delivery of exotique and the tumors. But unlike ADCs, this occurs in a tumor antigen independent fashion. The Xyralpha agreement gives us an option on a novel monoclonal antibody ADU-eighteen oh five, which targets SIRPalpha, the ligand for CD47. SIRPalpha CD47 is a major myeloid checkpoint And targeting SIRPalpha directly overcome some of the known issues with targeting CD47.

Speaker 5

These include the large PK SINK And potential for anemia due to expression of CD47 on red blood cell. ADU-eighteen oh five was carefully designed to target all human alleles of to give it best in class potential. Finally, in preclinical development, we have several biotherapeutics in the pipeline, Both ADCs and bispecifics. XB-three seventy one follows on from XB-two. It's also a tissue factor targeting ADC, but with the topoisomerase 1 inhibitor payload instead of the microtubule targeting payload on XB-two.

Speaker 5

Tissue factor is expressed on a broad range of solid tumors. So having 2 different tissue factor targeting ADCs with different payloads Allows us to match the tumor type with the mechanism of action of the payload to which the tumor is most likely to respond. XB-ten is also a next Generation ADC, but this one targets 5T4, another broadly expressed tumor antigen. XB-ten uses Catalent's Site specific conjugation and proprietary linker payload technology. The 2 bispecifics, XB-fourteen and XB-six combine the known pharmacology of PD L1 inhibition with inhibition of a complementary innate immune checkpoint, Either the myeloid CD47 checkpoint or the natural killer cell checkpoint MKG2A.

Speaker 5

In addition to these programs, we have multiple programs in discovery at earlier stages of maturity, both small molecules and biotherapeutics That will provide a source of development compounds and INDs going forward. Having multiple programs enables us to make decisions based on real time data To only prioritize those with the best potential for advancing successfully through clinical development. In fact, we're on track to deliver several new development compounds this Which will come from both our small molecule and biotherapeutics program. Our small molecule team reached critical mass last year We are able to complete the introduction of several key capabilities, one of which is structural biology to help guide the optimization of lead compound. Structural biology is one of the final components needed to get our small molecule discovery organization fully built out and I'm very pleased to say this group has been highly prolific.

Speaker 5

Despite being on the job for less than a year, they've already solved over 100 structures. And as you can see in this slide, They've delivered a steady stream of high resolution structures using both X-ray crystallography and cryogenic electron microscopy. These structures have been very helpful in guiding our medicinal chemistry efforts in our recent discovery program and in some cases have resulted in significant evolution of lead series For driving potency and selectivity. Using this approach, we've also been able to optimize known liabilities of lead molecules as a way toward achieving best in class status for programs with advanced competition. So if you may remember that in our original discovery platform, we also had a strong structural biology over 1,000 structures of kinase inhibitor complexes, which help drive dozens of discovery programs.

Speaker 5

That group had only x-ray So, with the introduction of cryo EM in this field, we're now able to get these structures faster than ever.

Speaker 3

So that's it for my remarks.

Speaker 5

And I'll now turn the call over to Vicki.

Speaker 6

Thanks, Dana. Today, I will provide updates On the progress of our clinical stage pipeline, focusing on our most advanced programs, zanzolatinib and XB-two As well as the cabozantinib registrational trial. XL-one hundred and two continues in dose escalation, And we are focused on reaching a gono go decision later this year. As we continue to refine the strategic approach for each of our pipeline assets, We retain a strong focus on clinical trial execution to rapidly advance our pipeline molecules With the ultimate goal of improving outcomes for cancer patients. I'll begin with zanzolitinib, our next generation tyrosine kinase inhibitor, Which entered full development last year.

Speaker 6

At ESMO last September, we presented data from our dose escalation cohorts of STELLAR-one, Which demonstrated that ZANZA has a manageable safety profile with no unexpected toxicities. Additionally, we presented preliminary evidence activity in renal cell carcinoma, including activity in patients who had previously been exposed to cabozantinib. We have since completed enrollment of an expansion cohort in clear cell RCC patients with 32 patients enrolled at the starting dose of 100 milligrams And now have preliminary efficacy data for the full cohort. These patients had received multiple prior therapies, With the median follow-up of 7 months, The overall response rate in the full cohort is 34%. Responses were seen in patients previously treated with cabozantinib As well as cabo naive patients, where the overall response rate was 50%.

Speaker 6

Additionally, there is one unconfirmed PR in the cabo naive population for whom we are awaiting the results of a confirmatory scan. We also continue to be encouraged by the emerging safety profile. The complete data set including both efficacy and safety is planned for submission to an upcoming medical conference Likely later this year. These data provide evidence for the activity of zanzolitinib in a cabo sensitive tumor type And provide additional support for leveraging cabo data to inform the XANZZA development program. We are continuing to enroll additional expansion cohorts in multiple solid tumors across both STELLAR-one and 2, As well as on dose escalation cohorts for the combination of ZANZZA with Aptulilag, the nivolumabrelatumab combination.

Speaker 6

Data from these studies will inform future registrational plans for XANZZA and we look forward to sharing these data as they mature. Turning to our ZANZZA Phase 3 study, we initiated the first study STELLAR-three zero three comparing the combination of ZANZZA with atezolizumab Versus regorafenib in patients with non MSI high mismatch repair proficient late line metastatic colorectal cancer With the primary endpoint of overall survival in the RAS wild type population. The hypothesis for this trial With based on promising cabozantinib data from 2 studies in similar settings, COSMIC-twenty 1, And Exelixis sponsored signal detection trial in combination with atezolizumab and Camilla, an investigator sponsored trial with response rates in the RAS wild type metastatic CRC population in these studies We're 25% 50%, respectively, suggesting robust activity relative to the current standard of care. Additionally, we announced the opening of STELLAR-three zero four late last year, a Phase 3 trial comparing the combination of ZANZA and nivolumab Tucinitinib in patients with certain non clear cell RCC histologic subtypes who have not previously been treated for metastatic disease. Data to support this trial came from 2 cabo studies, 1 as monotherapy and the other in combination with nivolumab.

Speaker 6

In an NCI sponsored randomized Phase 2 trial, cabozantinib showed a longer PFS compared to sunitinib In patients with the papillary subtype of non clear cell RCC and response rates were 23% for cabo and 4% for sunitinib. Promising activity of cabo in combination with nivolumab was seen in an investigator sponsored Phase 2 study Where the response rate in patients with non clear cell RCC was 47.5%. With these 2 Phase 3s now underway, We are also on track for the initiation of additional Phase 3 trials this year. We have selected the indications for the next 2 Phase 3 studies and we'll share details of the trial designs later this year. Moving on to XB002, our first We believe that this ADC has important areas of potential differentiation versus competitor molecules.

Speaker 6

First, the antibody was designed to avoid interfering with the coagulation cascade with resultant potential for lower bleeding risk. 2nd, the stability of the linker leads to reduction in circulating free payloads, which may result in fewer off target orastatin related toxicities, Including neurotoxicity. We continue to be encouraged by both the PK, which demonstrates low levels of circulating free payload, As well as the emerging safety profile. We are nearing declaration of a recommended dose for monotherapy And look forward to expeditiously enrolling multiple solid tumor expansion cohorts as well as presenting additional data as they mature. These signal detection cohorts will inform the drug safety and efficacy profile and allow us to pivot quickly into registration directed trial.

Speaker 6

Additionally, we continue to enroll on the dose escalation cohorts for the nivolumab and bevacizumab combination To determine a recommended dose for each combination to carry forward into expansion and we will continue to seek out other promising For cabozantinib, we look forward to the readout of the progression free survival primary endpoint for Contact-two, our Phase 3 study in combination with Atezolizumab in metastatic castrate resistant prostate cancer in the second half of this year. We announced in March that CONTACT-three, the Phase 3 trial evaluating cabozantinib in combination with atezolizumab Versus tabozantinib alone in patients with previously treated advanced renal cell carcinoma did not meet the primary endpoint of progression free survival. And along with our partner and study sponsor Roche, we look forward to presenting the data at ASCO. Importantly, the CONTACT-three study provides The largest data set to date on the performance of single agent cabozantinib in RCC patients who have previously received checkpoint inhibitor based therapy. In summary, we continue to make progress advancing our pipeline molecules and believe that the emerging data for both zandalitinib And XB-two are encouraging.

Speaker 6

We look forward to sharing the emerging data at upcoming medical conferences as they mature And continuing to expedite the development of these promising assets for the benefit of patients with cancer. And with that, I'll turn the call back over to Mike.

Speaker 2

All right. Thanks, Vicki. As you heard on the call today, The Exelixis team is off to a great start in 2023. We're excited to have the momentum from our cabozantinib franchise Translate to the critical growth drivers across all components of the business as we at Exelixis work to help many more cancer patients in the future. We expect continued progress across our pipeline in 2023 and look forward to sharing our latest results and plans And an R and D day later in the year.

Speaker 2

So I'll close by thanking the entire Exelixis team for their individual and collective efforts To support our range of discovery, development and commercial activities. The team is highly motivated to achieve our mission to Help cancer patients recover stronger and live longer. We drive for results every single day as we remain nimble and innovative We look forward to updating you on our progress in the future.

Speaker 7

Thank

Operator

you. To allow for everyone to get their questions answered, we will take a maximum of 1 question per person. Once you've asked your questions, Our first question comes from the line of At Stika Gomwodney with Truist, your line is open.

Speaker 8

Hello, yes. Just wondering about Zanzlanib, lastly you presented the first clinical data for it at ASMO. This year it seems like the submission deadline for abstracts for asthma 2023 is tomorrow. So can you tell us if you submitted an Abstract for an update to the ZANZZA combo Phase 1 dose expansion to ESMO or do you plan to do so before the deadline tomorrow? Thanks.

Speaker 8

And this has been Inanc on for Oscar.

Speaker 2

All right. Thank you. Vicki, you want to take that one?

Speaker 6

Sure. So, as I mentioned, we've now enrolled the full cohort. We have adequate follow-up In that clear cell RCC cohort, in order to report out response rates. And we do look forward to Presenting these data at an upcoming medical conference, hopefully later this year. I'm not going to comment further at this point on which conference that is.

Speaker 6

We, again, I think have now a robust data set to be able to present And look forward to sharing these results in more detail in the future.

Operator

Thank you. Please standby for our next question. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line

Speaker 2

is open.

Speaker 9

Hey, this is Paul on for Michael. Thanks for taking our question. Our question is on the Phase 1 study for The 2, so especially on the specifically on the cohort expansions, are you planning to prioritize any tumor types We've seen early clinical activity from that initial readout. And does moving that program into full development sort of suggest potentially 1 or more Phase 2 initiations in the near term? And then just on that as well, you've also added a tumor agnostic cohort to the trial.

Speaker 9

So I'm wondering just If you could talk about the enrollment criteria for that and sort of plans for a tumor agnostic path. Thank you.

Speaker 2

Vicki, go ahead.

Speaker 6

Yes. So in terms of XB-two, as I mentioned, we are nearing a dose to carry forward into expansion cohorts. We're looking forward to very quickly pivoting into those expansion cohorts, rapidly enrolling them, looking for signals, right? I think when we determine a signal that we're able to move forward with, that will be the pivot into full development. In terms of tumor types, obviously, we enrolled a very broad variety of tumor types and dose Escalation and so expansion is really going to be focused on determining signals in discrete populations.

Speaker 6

Of course, it will be informed by a competitor molecule and the profile that they've seen, But we are very encouraged by the data and the competitive profile. And so we think that We have a great opportunity here to be a best in class molecule. I would say with respect to the tumor agnostic, this is really an for us to look for evidence of activity perhaps in less common tumor types that do express tissue factor And get a better understanding of the potential impact of tissue factor expression on response rate.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Andy Hsieh with William Blair. Your line is open.

Speaker 10

Great. Thanks for taking my question. So you highlighted in the prepared remarks and PR about contact 03 at ASCO. And I'm just wondering about the kind of potential read through, especially the non clear cell Populations to STELLAR-three zero four. And maybe if you don't mind, I can squeeze a Quick one.

Speaker 10

About cryo EM and X-ray crystallography, these capabilities from a Philosophical perspective, R and D philosophical perspective, does that allow you to expand beyond trying to find A binding package like TKI into something that is more unique like an allosteric inhibitor? Thanks for taking my questions.

Speaker 2

Hey, Andy, it's Majdi. Thanks for your questions. Why don't we start with that last one with Dana and then we'll go back to Vicki for Contact 03. Dana, go ahead.

Speaker 5

Sure. Yes, that was a great question. And in fact, Yes, indeed. Getting those structures, especially getting them so quickly, gives us an opportunity to go for non orthosteric Finding approaches, so we are actually doing that with some programs right now. So The data coming in from those structural studies and coming in so quickly with such high resolution has really enabled some fantastic Progress in drug discovery, honestly, that we haven't been able to see in a long time.

Speaker 5

So we're really excited about it. Vicky?

Speaker 6

Yes. So with respect to CONTACT-three, I think it's important to keep in mind this Study looked at patients with previously treated RCC across both clear cell and non clear cell. These patients had already all received prior IO in addition potentially to TKIs. So that's been proven to thus far to be a very difficult area for drug development. I will point out That again, I think the cabo control arm will be interesting to look at in terms of the performance there Versus what we've seen historically and if we go back and think about cabo development in a later line of therapy, Going back to METEOR where we saw a response rate of about 20% and PFS of about 7.5 months To then, Cantata, where again, cabo was a control arm in a Phase 3.

Speaker 6

In that case, that second case, Some but not all patients had received prior checkpoint inhibitors and the median PFS was about 9.3 months. So compared to A checkpoint naive population, it does seem that there has been some improvement in cabo performance in that second line. So I would recommend taking a look at the CANTT-three data closely in terms of cabo performance. In terms of the STELLAR, 304, this is a first line Population, I outlined in my prepared remarks, the basis, the reason to believe here in terms of the prior CABO data, Which has shown activity in non clear cell RCC. So, we do have confidence that The activity we're seeing with ZANZZA in terms of RCC in a sensitive tumor type similar to cabo It gives us confidence in the design of STELLAR-three zero four.

Operator

Thank you. Please standby for our next question. Our next question comes from the line of Chai Fong with Bank of America. Your line is

Speaker 11

Hey, this is Chi Fung on for Jason Gerberry from Bank of Okay. Thanks for taking our questions. Maybe just one for me on early pipeline. Interesting you have highlighted small molecule focused on synthetic So let's see. I think in the past when we have spoke about pipeline companies more focused on antibody biologic therapies And less so on small molecule and also less so on targeted oncology.

Speaker 11

So I'm curious If I misunderstand synthetic lethality inappropriately that you're not looking at anything in terms of target oncology and Well, if there's a change in messaging or how the company think about early pipeline development compared to the past? Thank you.

Speaker 2

That's a great question.

Speaker 5

So synthetic lethal approaches are really a way to understand more How tractable a target is in a specific population of patients. We like the approach as do many others because It essentially comes along with an automatic patient selection strategy. So you can liken this To cabozantinib in BHL defective tumors, BHL defects Create a form of synthetic lethality to these types of kinase inhibitors that we're developing with cabozantin and mesolitinib. There's really no change In our strategy, we just have tools that enable us to get a better handle on patient population. So and as Mike mentioned earlier, we really are pursuing a biology centric modality agnostic approach.

Speaker 5

So we choose our small molecules versus biotherapeutics based on the target and the biology To allow us to really explore targets that we think will bring the most benefit to patients.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Jay Olson with Oppenheimer. Your line is open.

Speaker 12

Hey, congrats on the progress and thanks for taking the questions. For Zanza, can you just talk about the timeline and tumor types that you're Prioritizing for the next wave of Phase 3 programs and how do you intend to trade off The balance between indications where you've already seen activity for cabo versus going after new combinations. Thank you.

Speaker 2

Thanks, Jay. Vicky, you want to take that?

Speaker 6

Yes. So as I mentioned, we're on track For initiating additional Phase III trials this year, we have picked out After a process of thinking about areas of unmet need, where we have data, where we believe we can differentiate, And also considering bringing in novel combinations and really the size of the market opportunity, we've Excited on 2 indications. We will make some give you some updates as far as those indications later this year at the appropriate But we're working through protocol developments in advance of initiating those trials this year.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Gregory Renza with RBC Capital Markets. Your line is open.

Speaker 1

Hi. This is Ying Huang for Greg. Thanks for taking our questions. Maybe just one on the share repurchase program. Just wondering if that's currently active and Or was used in the Q1 or April?

Speaker 1

Or do you plan to start utilizing it now after Q1 earnings? Thank you.

Speaker 3

Yes. So thanks for the question. Yes, I mean, when we announced the program, we were in a closed trading window. So we haven't been able to purchase shares. But we are we continue to be committed to the $550,000,000 share repurchase program we announced in March.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Silvan Turkan with JMP Securities. Your line is open.

Speaker 12

Thank you very much for taking my question and congrats on the quarter. Just one question that One after you have talked about is the CK7 inhibitor XL-one hundred and two. Do we still expect data by the end of the year? And could you kind of outline What would lead to a go or no go decision here? What's the bar that you're looking for?

Speaker 12

Thank you.

Speaker 2

Yes. Thanks for the question. Vicki, you want to take that?

Speaker 6

Sure. Yes. So as I mentioned, we are focused on Dose escalation and making a go, no go decision later this year, that will be based on the data at the end of the day. So both the safety profile, Evidence of activity as well as PK and PD data. And in terms of data presentation, again, when we have a robust data set to Present, we'll certainly do so as those data are mature.

Speaker 1

Thank you. Please

Operator

stand by for our next question. Our next question comes from the line of Akash Towari with Jefferies, your line is open.

Speaker 7

Hi, this is Ivy Ma with Barkush. Thanks for taking our question. So our question is on the R and D spend. I guess, do you have a

Operator

sense of what level of R

Speaker 7

and D spend as percentage of revenues the activist shareholders want you to commit to Versus what the management team wants? And additionally, what in general the split is for your R and D spend this year, That's for trials for Cabo and trials for next gen Cabo and tissue factor ADC and everything else. Thanks.

Speaker 2

Thanks for the questions. There's a lot there. Really don't want to get into the details about the R and D spend. We gave guidance on that at the beginning of the year. We reaffirm that guidance this year.

Speaker 2

As you heard In our prepared remarks, we have a very deep and robust R and D pipeline that's focused on Improving standard of care for patients, that budget and all aspects The efforts here at Exelixis are obviously reviewed by the Board and a very robust discussion that will continue as we go forward. And we're excited to be moving forward with the plans and the data that we've talked about today and will in the future. Thank you.

Operator

Our next question comes from the line of Yaron Werber with Cowen. Your line is open.

Speaker 13

Great. Thanks for taking my question. I have A couple sort of interrelated questions. Maybe the first one, just give us a little bit of a sense, I mean, you have a fairly extensive pipeline now Looking from Phase 3 all the way to preclinical, are you still do you have room to bring in more compounds or is it going to be mostly Sort of advancing what you have now and pushing the preclinical programs into the clinic. And then secondly, just any comments you can make relating Your decision 2 days ago not to nominate an additional board member that ended some of the proxy battle for the time being.

Speaker 13

Thank you.

Speaker 2

Yes, everyone, it's Mike. Thanks for the question. In regard to the first question, we are focused on prioritizing The best assets with the best data and the conviction that we have behind that in terms of how we invest in moving molecules forward. Internally versus externally small molecules versus biologics, obviously, we've got a traffic and a success there, Which led to us focusing on cabo back in the day and the success that led to that in terms of the broad label and Again, the approximate $1,900,000,000 in global revenue that we had last year. So we know how to be disciplined.

Speaker 2

We know how to prioritize. That requires data and a sense of the commercial opportunity and the competition and all the different factors that drive into that. And that obviously will continue going forward. We're always looking for good assets on the outside that will continue. We have a very high bar for partnering and or acquiring assets.

Speaker 2

As you know, our scientific conviction is much more Precian is much more critical to us in the short term in terms of the value equation, in terms of Where things are trading a year ago versus now, we have to have conviction in assets externally or internally To get behind them with the financial muscle that we've got and certainly the expertise in development As well as commercial. So it's all about conviction and probability of success in our view and how that looks. So that will continue. We're on the lookout for good drugs and certainly as Dana mentioned, we like deals like SYBREXXA and XEROLA because those are back end loaded. We pay for And if we see more of those in the near term, then our plan is to be able to transact there to Again, build value for patients and shareholders.

Speaker 2

In terms of your other question, I'll refer you back to the press release we had on Sunday. I don't want to go beyond that. We have an open spot on the Board. We've agreed to not amongst ourselves as The company and the Board did not contest the election and we're moving forward. So that's that.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Michael King with EF Hutton. Your line is open.

Speaker 14

Thanks for taking the questions guys. I'm not sure you want to get into this level of detail, but I had some questions on the spend. In the Q1, you guys exceeded the Street Consensus by about $20,000,000 and if you use the level in the Q1 as the base and grow it modestly So the end of the year, you're above the high end of your spend guidance, which suggests that you're going to have to dial down the growth and spending on SG and A. And then on R and D spend, in the past you've had a pretty big bolus in the Q4. I'm just wondering from a maybe an order of magnitude basis That kind of increase over the previous quarters is going to moderate a bit because again you'll come in over the high end of your Ben, so just wanted to see if I can get some color on that.

Speaker 3

Yes, Chris, go ahead. Yes, Mike. So I guess a couple of things there from an R and D spend Perspective, last quarter we had about $100,000,000 or more of licensing expenses that came into play during the Q4. We had significantly less than that in the Q1 here. I mean, if you look at the annualization Our Q1 spend, it's slightly below our current R and D guidance from an R and D perspective, but we still feel confident where we are there.

Speaker 3

From an SG and A perspective, we did have some one time things, which I won't go into. But even at 131, annualized that, that's at The $5.49 range. So we're still kind of at the lower end of the guidance. So or within the guidance. And we did have Onetime things during the quarter, which as one time things, they don't repeat themselves.

Speaker 3

So we still feel confident in the guidance that we have.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Chris Shibutani with Goldman Sachs. Your line is open.

Speaker 15

Great. Thank you very much. Mike, you've had such a significant tenure in the industry and certainly have been generating much by shepherding, particularly cabo Through challenges of becoming a leading product in the oncology space, as you bring to bear your And think about the future, I think a lot of investors in therapeutics think about now into the back end of the decade, Where there will be certain pressure points like the IRA and whatnot and the differences with small molecules and thinking about how to design the strategy to sort of Sustain that kind of leadership, I think one of the things that I'd be curious to understand is how you think about, In particular, the voices that could be important to you with the Board, there is that one opening seat and there were public salvos That went back and forth in terms of the right constituencies and what kind of activity invoices, etcetera. What is your vision for What kind of sort of complementary skill sets and experiences would make sense for your Board To help best guide the company to continue to go forth as challenges just continue to be very competitive external dynamics To the back end of the decade.

Speaker 15

And again, just speaking to the wealth of the experience that you've had, would be very eager to sort of get a sense for what your vision is there. Thank you.

Speaker 2

Thanks for that. I'm not exactly sure what the question was. But let me speak to What I think you're asking, again, as I just mentioned or talked about in the context of, I think the question from Yaron, The proxy issues are from our point of view as we talked about On the press release on Sunday, we're not going to contest the election as it's currently envisioned. So what will happen will happen. We have a very Strong Board.

Speaker 2

I expect we're going to have a strong Board going forward. We have a very good Process, I mean, within the company and the dialogue that we have with the Board, the dialogue, the discussions, the debates, the arguments that I think our healthy from the standpoint of really refining and optimizing our chance of success as a company as we again Seek to build shareholder value by helping more patients with cancer. Again, as I mentioned in my prepared remarks, those two goals, those two Topics have to travel together. That's a business that we're in. Again, we're really excited about our future.

Speaker 2

We have, As you heard from Vicki, today with Zanza, strong momentum with that program, XP002 Is one step behind that in terms of entering expansion cohorts very quickly. The wealth of opportunities we have From internal sources, from external sources is strong and by the fact that going back to as early as 2015, We built the company to actually run like a business from the standpoint of generating free cash flow and using that to fund our ability to drive Top line growth through pipeline advancement. So we're really excited about where we're at. We're looking forward. We've got a lot of opportunities.

Speaker 2

The team is very strong and Has very good morale right now and we're looking forward to doing well by shareholders, while we help patients with cancer on a much broader basis than we have in the past.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Peter Lawson with Barclays. Your line is open.

Speaker 16

Great. Thanks for taking my question. Chris, just As we think about the underlying script growth, kind of any guidance there and kind of expectations for the kind of the level of Discounts, allowances, and how that trends through the rest of the year?

Speaker 3

Yes, Peter. Thanks for the question. So, we did see around 30% gross to net in the Q1. Like I said in the prepared remarks, we did see higher Medicare Part D, patients are going through the donut hole and also PHS expenses. When I talked At the Q4 call back in February, I was thinking that the year is going to be in the 31% range for gross to net and we still feel like that's the appropriate range for right now, but it's still early in the year.

Speaker 3

So that's where we are from a gross to net perspective.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Stephen Willey with Stifel, your line is open.

Speaker 17

Yes. Thanks for taking the questions. So just on STELLAR-three zero 3 in colorectal.

Speaker 3

I don't

Speaker 17

think there's been much in the way of clinical benefit demonstrated in patients with liver mets With any IL regimen and I think both the Phase 2s you referenced had a pretty high incidence rate of liver mets, I think somewhere around 80%. So I guess I'm just curious what you think the inclusion of atezo is adding in this Liberumab patient population? Thanks.

Speaker 2

Vicky?

Speaker 6

Yes, sure. So, I think coming back to STELLAR-three zero three, this is A Phase 3 study looking at the combination of ZANZA with atezolizumab versus regorafenib In late line colorectal cancer patients, right? I think these patients have very limited treatment options. The rationale, as I said, is supported by 2 essentially Phase 2 kind of single arm trials. One was a cohort on COSMIC-twenty one and the other was an IST, right?

Speaker 6

And they were very similar patient populations In terms of this sort of late line previously heavy treated, as you mentioned, liver mets are very common in colorectal cancer, so They were certainly represented in both of these trials. Given that they're single arm trials, I would say that, what we're seeing, however, is that there's a clear signal of response rates Outside of what we would expect from traditional standard of care, on the order of 50% From the Camilla IST and 25%. Now that's in the overall population, of course. We do believe it is the combination based on other data looking at contribution of components. Obviously, that will be something that we have to address With the regulatory agencies at the time we file, should the trial be successful, but we do feel like we are well positioned Potentially to improve upon the standard of care in this particular high unmet need patient population.

Operator

Thank you. Due to the interest of time, I would now like to turn the call back over to today's host, Susan Hubbard. Ms. Hubbard?

Speaker 1

Yes. Thank you, Towanda. Thank you all for joining us today. We certainly welcome any follow-up questions you have either by phone or over email and we'll be happy to get back to you. Thanks, Ken.

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.

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Earnings Conference Call
O-I Glass Q1 2023
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