G1 Therapeutics Inc. Q1 2023 Earnings Call
Speaker 2: all participants are in listen only mode. After the presentation, there will be a question and answer session.
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Speaker 2: Please be in line that today's conference is being recorded. I would now like to hand over the conference to your speaker today, Will Roberts and Communications. Will please go ahead. Thank you, Mark. Good morning, everyone, and welcome to the G1 conference call. It's got our first quarter, 2023 financial results and business update. The first release on these financial results was issued this morning. If it can be found in a new section of our corporate website, g1350.com.
Speaker 2: or to a fatigue and containing regimen for extensive state-small cell lung cancer. As Mark mentioned, the Q&A session will follow the prepared remarks. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the private security litigation reform at the 1995. Such statements represent management's judgment as of today, and many both risk and uncertainties that could cause actual results to differ materially from those expressed in, formed by these favorites.
Speaker 2: Any forward-looking statements are present our views as of today, May 3rd, 2023. Joining me on the call today are Jack Bailey, Achieve Executive Officer, Andrew Perry, Achieve Commercial Officer, Raj Malik, Achieve Medical Officer, and John Umstead, Achieve Financial Officer. And with that, I'll turn the call over to Jack. Jack. Thanks, well, good morning, everyone, and thank you for joining us on the call today. As you will hear from Andrew momentarily, our goal in the first quarter was to accelerate the Cosella Volume Grove we saw in the fourth quarter of 2022 by building the platform of deeply adopting customer organizations.
Speaker 2: and we've executed on Mechle. The team grew by all volume by 21% over the prior quarter.
Speaker 2: March was our highest volume month to date, and April was also one of our highest months. We have continued to learn and evolve our sales efforts. We are identifying the right combination of activities directed to the right accounts primarily in community settings. In the first quarter of 2023, successful execution of these commercial initiatives and positive experiences with the drug led to increase penetration and improve results. Re-enforcing our confidence in achieving our sales guidance.
Speaker 2: Updated data are being presented from those two phase twos later this quarter, and the interim OS analysis for the TMBC Phase III is now expected to occur in the first quarter of 2024. And as mentioned on our last call, we are conducting our business in a manner that is mindful of our cash and expenses, with the goal of extending our cash runway through all of our clinical readouts.
Speaker 2: To that end, we announce this morning that we have proactively strengthened our balance even further in a manner that is non-equity diluted to our shareholders by monetizing all future royalties and milestones from sincere.
Speaker 3: As we've previously stated, in the extensive state's small cell lung cancer market are quarterly growth as highly reliant on gaining new patients, either from new accounts or from existing accounts in order to compensate for patients who complete their chemotherapy regimen and drop off therapy. In the first quarter or third.
Speaker 3: we brought on board 95 new accounts, which was roughly similar to the fourth quarter of 2022.
Speaker 3: March was our best month on record for new accounts with over 40 adits.
Speaker 3: Many of these new accounts are affiliated with larger parent organizations, and we added three new top 100 organizations in Q1, giving a total of 72 of the top 100 which have ordered Cousela launches today.
Speaker 3: In Q1, 54.100 and 200 organizations in total have orders, which is our broadest set of ordering customers lodges today. Our reorder rate remains high, and over 80% of ordering customers reordered within the exemption from the UN law. It's abliure one, it's a
Speaker 3: Going forward, although new top 100 customers remain a focus, consistent and deep ordering from large customers is more important for sustained growth.
Speaker 3: With regards to improving that adoption, we had 17 organizations in Q4 which ordered more than 100 files per quarther and 19 in Q1.
Speaker 3: and Q1R.5 customers order 20% of total volume in the period, which is several hours of what we saw in Q4, although the wisdom change in the organizations which composed the top five has some begun to adopt more deeply.
Speaker 3: Our focus in community oncology includes working with customers to understand multipleismen focus CEO and their enmar
Speaker 3: In Q122-23, customers who elected the place Cosella in a default position as their standard of care demonstrate roughly four times the death of utilization compared with customers who simply left Cosella as an option.
Speaker 3: Also among those organizations which adopted more deeply, we're both engaged in our volume-based contract agreements.
Speaker 3: Volumes in our contracted customers increased 50% during the quarter.
Speaker 3: By the end of Q1 roughly 15% of our business was with customers who have a volume agreement and we have several new agreements, no active, NQ2, where we see potential for the first option.
Speaker 3: We saw 78% of volume in the quarter come through community clinics and hospitals and 22% of volume from academic centers. 98% of our volume in the quarter was in commercial supply, but 2% provided through our patient assistance program. Our pair of next remains stable with the majority covered by Medicare and third-party pair reimbursement has remained strong. Moving into Q2 2023, April has also been one of our highest volume months, although all of these volume is conveyed in month to month due to the limited duration of chemotherapy and small cell lung cancer.
Speaker 3: Our execution continues to focus on large community oncology customers, and we're seeing the benefits of the strategic shifts we've made over the last two quarters. We will continue to evolve our commercial model as necessary to achieve our ambitions for Crocell. With that, I'll turn the call over to Raj.
Speaker 3: Thanks Andrew and good morning. I'll provide an update on the important data readouts coming over the next few quarters and the exciting data expected early next year. Updated results from our combination trial with the ADC sassatuzumab have been accepted for poster presentation during the ESMO breast cancer conference on May 12.
Speaker 3: This presentation will also include initial efficacy results, including outcome by Tumor PD-L1 status, a topic I'll discuss further in a moment. The most important data from this trial will be the overall survival endpoints, which we expect to reach in the first quarter of 2024. Similarly, updated results from our mechanism of action trial in neo-adjuvant TMBC have been accepted for presentation at the ASCO meeting on June 4.
Speaker 3: Initial data presented last year showed favorable alterations in the tumor microenvironment following a single dose of trial cycle monotherapy.
Speaker 3: with a trend towards an increased CD8 positive T cell to Treg ratio.
Speaker 3: demonstrating the immunomodulatory effects of trilocycline. The ASCO data will include tumor pathological complete response and potential correlations with molecular analyses of tumor and baseline and following the single dose of trilocycline.
Speaker 3: Ethological complete response results will also include outcome by tumor PDL-1 status. Next, we expect to provide additional safety and efficacy results, including preliminary progression fee survival results from Preserve 3 in bladder cancer in the middle of this year. We'll then look forward to the important overall survival endpoints which we expect to reach in the first quarter of 2024. Finally, following a recent evaluation of blinded events, we now estimate that the interim overall survival analysis of the Pivotal TMBC trial will occur in the first quarter of 2024.
Speaker 3: that showed a statistically significant overall survival advantage for patients enrolled in both trial cycle of arms compared to placebo with hazard ratios of 0.31 and 0.4 respectively. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the top-line results. If it does not, the trial will continue to the final analysis. As we approach these data, including the phase IIs, over the coming months, it's important to keep in mind what we have learned from prior studies, including the phase II TMHC trial, namely that trial cycle appears to have the greatest effect on longer-term patients.
Speaker 3: For example, in patients with PDL-1 positive tumors, which usually have an immune inflamed tumor microenvironment, we observed a numerical improvement in earlier efficacy metrics, including overall response and progression-free survival. Additionally, the capramycurs for overall survival separated early and continued to improve over time. This led to a median overall survival of 32.6.
Speaker 3: of 32.7 months for patients receiving trilocyclib, compared to 10.5 months for patients receiving chemotherapy alone. When disorders arise physical fading canthere in need of a Su Rye to help? It is beads
Speaker 3: of 32.7 months for patients receiving trilocyclib, compared to 10.5 months for patients receiving chemotherapy alone, with a hazard ratio of 0.34.
Speaker 3: On the other hand, in patients with PD-L1 negative tumors, which tend to have immune-excluded or immune-desert-tumor microenvironments,
Speaker 3: We did not observe a meaningful improvement in response rate or PFS.
Speaker 3: compared to 13.9 months for patients receiving chemotherapy alone. More interestingly, the Kaplan-Meier curves for overall survival did not separate until about 15 months, but this separation then continued to accelerate over time, leading to a hazard ratio of 0.48, which is a very robust result in these patients with PD-L1 negative tumors, excuse me. So while we will watch the early measures of response in PFS that we'll present in the coming months, we're most interested in following these patients for overall survival to evaluate whether Trelleciclid can meaningfully improve patient outcomes.
Speaker 3: in these particular settings. As I mentioned, we currently anticipate that we will reach the overall survival endpoints.
Speaker 3: for the ABC and bladder phase two studies.
Speaker 3: the ADC and Bladder Phase II studies in the first quarter of 2024.
Speaker 3: This is approximately the same time we expect to see the interim OS analysis for pivotal first-line TMPC trial. So early next year, it will certainly be an exciting time for us.
Speaker 3: With that, I'll turn the call over to John for a review of the financial results.
Speaker 2: Thanks, Raj, and good morning, everyone. As we'll mention, full financial results for the first quarter 2023 are available in this morning's press release and will be in the 10Q which we expect to file today after market close. Our total revenue for the first quarter of 2023 was $12.9 million.
Speaker 2: comprised of net casella revenue of $10.5 million and license revenue of $2.5 million.
Speaker 2: The license revenue from the current quarter is related to supply and manufacturing services with sincere, royalty revenue from sincere, and clinical trial reimbursements from EQRX and sincere.
Speaker 2: For the same period in 2022, total revenue was $6.9 million, including $5.5 million of net product revenue.
Speaker 2: Call some good sold for the three months in March 31st, 2023 was $1.5 million compared to $700,000 for the same period in 2022.
Speaker 2: Our research and development expenses for the first quarter of 2023 were $15.5 million compared to $26.3 million for the first quarter of 2022.
Speaker 2: The period over period decrease in R&D expenses was primarily due to reduced clinical trial costs.
Speaker 2: Our selling general and administrative expenses for the first quarter of 2023 for $21.8 million compared to $26.7 million for the first quarter of 2022.
Speaker 2: Compared to two periods, the decrease in SGNA expenses was primarily due to decreases in commercialization activities, personnel costs, and professional fees.
Speaker 2: As we mentioned on the last call, while we expect our 2023 operating expenses to be 20-30% lower than that of 2022, we didn't see the impact in the first quarter due to severance and costs associated with winding down Preserve 1.
Speaker 2: we ended the first quarter with cash, cash equivalents, and liquid securities of $116.3 million compared to $145.1 million as of December 31, 2022. While on the topic of our cash position, as Jack mentioned at the start, we are now on the topic of cash.
Speaker 2: We announced this morning that we strengthened our balance sheet even further without issuing additional equity by monetizing the future royalties and milestones from some seer, which brings us $30 million as of the current quarter and up to $48 million in total. The additional $18 million are pending positive data from our ongoing...
Speaker 4: remain in place, including data sharing and participation cost sharing in global clinical trials of trilocycline.
Speaker 4: As a result of this transaction, we are now able to extend our cash runway even further into 2024, beyond the readouts of our clinical trials that Raj discussed earlier.
Speaker 4: And as a reminder, Greater China was the only partner in geography. As such, we retained the rights to develop and commercialize trial and cycle throughout the rest of the world.
Speaker 4: Finally, regarding revenue and cash run rate guidance for 2023. Today we reiterated our net product revenue guidance for 2023 of a range between $50 million and $60 million.
Speaker 4: We can serve itably estimate our 2023 grossed and at expense percentage to be in the low to mid-20s primarily due to the potential impact of the wastage provision of the 2021 infrastructure bill.
Speaker 4: As a result of our revenue, expense, and cash guidance, we anticipate a year-end cash, cash equivalents, and marketable securities balance of approximately $70 to $80 million before taking into account the impact of the sincere monetization I discussed earlier.
Speaker 2: With that, I'll turn the call back over to Jack for some closing comments. Jack. Thank you, John , Raj, Andrew, and Will. And it's always a thank to people living with cancer for your inspiration. They drive us toward our goals every day.
Speaker 2: Now as you heard from Andrew, we remain confident in the potential of Cocella and lung cancer and are making good progress in driving real results. During the first quarter, we grew bile volume by 21% and net product sales line by 18% over the prior quarter. We brought on board 95 new accounts.
Speaker 2: March was our best month on record for both files and new accounts. Regarding death, we had 19 organizations at more than 100 files during the quarter compared to 17 in the fourth quarter.
Speaker 2: and volumes in our contracted customers increased 50%. Given this, we have reiterated our CoSellent net sales guidance of between $50 and $69 million for 2023.
Speaker 2: Beyond the sales line, we expect to present additional results from both of our ongoing phase two TMBC trials, including by tumor PDL1 status later this quarter.
Speaker 2: mid-year. And as you heard from Raj, we now expect the interim OS analysis for the pivotal Phase 3 TMBC trial will occur in the first quarter of 2024.
Speaker 2: Finally, we have added additional near-term capital to extend our cash runway even further beyond the important clinical trial readouts expected in early 2024.
Speaker 2: We are one of the very few companies in our sector that not only have a late-stage pipeline with pivotal data expected in less than 12 months, but also have an approved product that is novel, important, and growing, which, assuming we hit our internal forecast, should drive us to cash flow positivity in the next few years.
Thank you for your time this morning. We will speak again in this format on the second quarter, 2023 call in August , and we'll have a variety of opportunities to communicate the upcoming results from our Phase 2 trials throughout the year. With that, I'll close the call, turn it over to Q&A, operator, would you please remind our listeners how to ask a question.
Thank you. At this time we will conduct the question and answer session. As a reminder to ask a question, please press star 11 on your telephone.
and wait for your name to be announced. To withdraw your question, please press star one one again. Now please stand by while we go ahead and compile our Q&A roster.
And thank you for waiting. Our first question will be from Neil Bloom of Needham and Company. Go ahead, Neil.
Good morning everyone and congratulations on the continued execution here. So maybe maybe one because I don't know if I heard this very well. How many centers went on you know?
So at this point roughly around a dozen of our organization customers have COSELA as the standard care default selection in their EMR and one of the executional strategies we have is to continue to work with organizations to educate them about how they can do that for themselves.
So we're excited about the potential that that offers and we see that as a great growth strategy moving forward.
Thank you for the clarification. Raj, maybe a couple for you here.
We're looking for the Trudelebi data on my fault at a poster and it's interesting. I mean, you've been carefully guiding that the more important readout it's going to be at OS, but...
What can we learn at this interim, and what could be further steps? Yeah, thank you. So the data that we'll present—
will be the updated safety data. Sorry, I've got a bad cold or something today. But as well as response rate and early PFS data.
But the important point is really the OS data.
And the reason for that is, as I mentioned, just the effect on long-term immune surveillance, which we believe is
through generation of more memory T cells. So, but we will present the response rate and PFS data that we have. That should be considered immature at this stage as well. And kind of a very similar topic.
You will be presenting the assess data from the bladder cancer study. Assuming, you know, on the positive end here that you see a season separation of curves there, I mean, that's the possibility and it should reflect on future OAS, shouldn't it?
That is correct.
Okay, I look forward to hearing more at the end of – at the beginning of next year. It sounds like you're going to have a pretty busy first quarter. Thank you.
Okay, I look forward to hearing more at the beginning of next year. Sounds like you're going to have a pretty busy first quarter. Thank you. Yep. Okay.
And thank you. Please wait while we bring our next question to the...
And our next question will come from Ed White, HC Winrate.
Yes.
Good morning. Thanks for taking my time.
So, last quarter, you mentioned that patients were on drug for roughly 3.3 to 3.5 cycles.
I'm just wondering if that number is holding and if there's anything that can be done to increase that duration.
And then also how should we think about the only the time tations will be on drug
and triple negative breast cancer once that indication is approved. Hi, thanks for the question. Yes, so the standard for first-line patients undergoing chemotherapy is four cycles and the 21-day cycles, so it's an 84-day duration of therapy. So on average, we see and it always covers me.
account has is actually a patient in the second or third cycle who already has reached a point where they've discovered that existing standards of care no longer apply or help that patient. So I would expect as we continue to bring onboard new accounts that that number will hover between the three and three point five. In terms of extending duration, so obviously TopTecan patients do extend further because they're...
potential and triple negative bref house. So that's a very exciting proposition to be able to build a larger market presence of more duration of therapy. Great, thanks Andrew. And just a housekeeping question you mentioned that. Rose didn't ask for the years expected to be in the mid-20s. What was it in the first
So that's a very exciting proposition to be able to build a larger market presence of more duration of therapy. Great, thanks, Andrew. And just a housekeeping question, you mentioned that. Rose didn't ask for the years expected to be in the mid-20s. What was it in the first quarter?
It was just under 21% for the first quarter. Okay, and then my last question is just regarding the sincere
payments with the 18 million left, the five, and then the 13 on approval.
You know, not being as familiar with the Chinese regulatory agency as I am with the U.S., can you give us any guidance on the timing of when you expect to receive those two payments?
Yeah, and this is Jack. I would, you know, you somewhere around one quarter delayed from the US, so usually take some two to three months to be able to, you know, get all the requisite data and submit it, but you're only talking about a quarter delayed from us. So, when you see our filing date, adding a quarter would be safe and you can expect that in the Chinese market.
Our next question will come from Dane Lyon of Raymond James.
Thank you for taking the questions and I'll talk to you about the commercial trajectory. Two questions for me. Maybe first one for Jack. You know, I think you got the commercial trajectory and the current op-x burn. What, you know, if we...
obviously assume you know the bulk of R&D or from the ongoing studies that you have discussed today, take that into account. How much SG&A could be rationalized to theoretically hit a positive EBIT margin on the current Coppella commercial trajectory or where that breakeven point would theoretically be?
And then secondly, maybe for, I guess maybe for you Jack again, strategically with preserve three and bladder cancer.
The primary endpoint of this study is PFS. I think Raj was talking about OS or something like that. But the reality seems to be if you have an equivalent outcome in the second quarter here on PFS to the standard of care arm, but you have an advantage in terms of mild protective effects, could you actually file on that for a label expansion with this study?
The reason I ask that is kind of twofold. One, because that's kind of the label on myeloprotection versus primary outcomes. But secondly, with the EV302 study you're reading out before the end of the year and likely going to be positive. So, that's kind of the label on myeloprotection versus primary outcomes.
Even if you had some hint of a PFS advantage that then becomes debatable within the question of what happens with a different frontline regimen. So what this smart move just did, see if you could file on the frontline, team of standard of care under a mile of protective effect.
now versus, you know, wait and then, you know, have to manage the complexity of maybe a shift in frontline care. Thank you.
Yeah, thanks, Dan. I'll tackle the first one and then flip it over to Raj for the second one. I think when you look at the actions we've taken in terms of reducing our burn and the trajectory of sales, we're, as we mentioned, sort of, I would say two years from being cash flow positive and having profitability in our site.
important point just to mention on TFS.
A rationale for doing the study was looking at how trial are combined to evaluate the I.O. enhancing effect of trial.
Regarding Myelo, a couple of points there. I think to recall that this is a gemocidabine-containing regimen, and we have not seen any Myelo effects with TMBC. So we think it's unlikely that we'll see that with the bladder regimen. However, it depends on what the data are, and then depending on the strength of the data.
Okay, thank you.
we'll bring up our next question.
Our next question will come from Troy Langford with TD Cowan.
Hi, everyone. Thanks for taking our questions and congrats on all the progress this quarter. We just have two quick ones, one commercial one and then I have a follow-up for Raj after that.
So just quickly on Cicela given the Cicela members for the quarter just how do you all think or how do you all expect the sales trajectory to Incelect over the course of the year and what else you all think you need to do in order to hit your internal expectations for the full year 2023 Cicela sales? We've got it.
Yeah, as we said before, month to month can be a little bit choppy, so we may see some ups and downs on a month to month basis. We do predict ongoing growth through the year to have that guidance though, based on what we've seen. And I think the new accounts we added in March is a good testament to the level of demand that there is still out there for the product. And it's obviously a good way to enter a new quarter with a number of years.
small cell is still a relatively rare tumor type, so the more reminders we have in the system and ideally leaving to that EMR optimal placement helps make sure the cell is told the mind at the right time to be able to help patients. And then of course these following-based contacts really do a very similar thing which is to systemise the uptake of the product at an organisational level.
If we get those things right, we'll see more and more deeply-adulting organizations, which ultimately allows us to generate that overall in the market and will certainly give us the opportunity to hit those targets that we set.
Okay, great. And then just a clinical one for Raj. I guess in terms of the phase two combination data with TRD-LV, can you just remind us what you would need to see from that study in order to feel more confident in the decision to move forward in a pivotal study? Yeah, so as I mentioned, Troy, it's really the…
population compared to ASCEND. For example, we had many more patients who had prior checkpoints compared to that study.
So evaluating the response rate and the early PFS data in that context as well as the safety. But really it's the overall survival that we're most interested in looking at early next year, the first quarter.
response rate and the early PFS data in that context, as well as the safety. But really it's the overall survival that we're most interested in looking at early next year, the first quarter. OK, great. Thanks guys.
Thank you. Please stand by. Next question. Our next question will be from Anuban Rama with JP Morgan.
Hi guys, this is Priyanka An for Anupam. Can you provide more granularity on the cash for cash on me in regards to the sincere agreement?
through the trial readouts that Raj mentioned in the first half of 2024 and continuing on in the year.
readouts that Raj mentioned in the first half of 2024 and continuing on in the year. Gotcha. Thanks.
Thank you. Please wait a moment while we bring up our next question.
Our next question will be from David Neergarten with Webbush in Securities. Go ahead David.
Thanks for taking the question. I had a follow-up just thinking about the different toxins involved with the ADC versus the chemo and triple negative breast cancer.
Yeah, just going back to the read through, Kent, is that important to think about it? You know if there's any read through from.
the combo with Petridelvi versus, you know, the chemo backbone and next year in Q1 or the other.
the combo with Tridelvi versus the chemo backbone in next year in Q1 or is there any other data points we can, you know, we can, you know, we can, you know,
or read through to the TMBC study just so I'm understanding your question. Yeah, yeah, it's like, is there, I mean...
Well, it's maybe a more basic question. Can we read anything through from a study with a different drug partner with a different mechanism of action to another study that has two different chemo partners that have a different mechanism of action? Sorry to say it, but are we wasting brain cells here trying to think about that? Should we just look at the trial?
will be an additional important piece of information, obviously, but in terms of the phase three TMBC trial, it's really the phase two TMBC trial with Jim Carbo.
that provides the strongest evidence for what we may expect in that phase three. Okay, I just wanted to triple check on that. Thanks, guys.
Yep. Thanks, David.
Thank you. Please stand by for our next question. And our next question will come from Kaveri Polman with BTIG. Go ahead. Hey, good morning, everyone. This is Christian and I'm a associate here at BTIG. I'll be asking the question for Kaveri today.
So the first question is, I assume you have some theories on your drug interacting with chemo in a negative way.
If you go back to your preclinical data, are there any models where, in retrospect, kind of predict this that might be useful in finding combinations for the future?
Hi, this is Raj. So are you referring specifically to the colorectal study here in terms of...
When you refer to a negative way because we certainly have not seen that in small cell and TNBC where we showed an improvement in survival just to understand your question. Yeah, yeah, colo, that's the cancer. Yeah, so there we're actually doing a number of investigations correctly.
And so, you know, when we have those data, we'll obviously release them.
But you know, that's certainly one of our hypotheses, is was there an unexpected interaction with five of you?
that potentially resulted in the effect we saw. Oh, okay. That actually kind of brings me to my next question, which is.
that there have been some studies suggesting an antagonistic effect of giving CDK4 slash 6 inhibitors with chemo. And I was wondering if you saw anything like that with your preclinical models and for CRC where 5-FU is used, how clear is the regimen that suggests that using tril DownsFC before chemo?
is the best way to see the benefit versus with chemo or a little later after chemo? Yeah, so specifically for preclinical work, I mean, we have done work with 5-FU in combination actually with a checkpoint inhibitor plus Trival, which showed an improvement in efficacy.
And we, of course, had lots of data with five of you showing the mile of protection benefits. So again, there was no...
There was certainly no data pre-clinically to suggest that we would see what we saw in colorectal. And we also did that work with other chemotherapies as well.
We're definitely expanding our work with looking at different chemotherapies now, given this data, to better understand it. Okay. Thank you so much for providing that clarity.
But we're definitely expanding our work with looking at different chemotherapies now, given this data, to better understand it. Okay. Thank you so much for providing that clarity. Sure. Okay. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.
So thank you everyone for your questions. I will now turn it back to Jack Bailey, CEO , for closing remarks. Thank you, operator. As always, we look forward to keeping everyone updated as we progress. Thank you for joining us on the call today. We'll speak again soon. Thank you, everybody, for your participation. This now concludes today's session.
I'll see you next time.