Arcus Biosciences, Inc. (NYSE:RCUS) Q4 2023 Earnings Call Transcript
Arcus Biosciences, Inc. (NYSE:RCUS) Q4 2023 Earnings Call Transcript February 22, 2024
Arcus Biosciences, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Hello and welcome to the Arcus Biosciences Full Year/Q4 2023 Earnings Call. My name is Elliot, and I’ll be coordinating your call today. [Operator Instructions]. I’d now like to hand over to Pia Eaves, Vice President of Investor Relations. The floor is yours. Please go ahead.
Pia Eaves: Hello, everyone and thank you for joining us on today’s conference call to discuss Arcus’s fourth quarter 2023 financial results and pipeline updates. I’d like to remind you that on this call, management will make forward-looking statements, including statements about our cash runway and our expected clinical development milestones and timelines. All statements other than historical facts reflect the current beliefs and expectations of management and involve risks and uncertainties that may cause our actual results to differ from those expressed. Those risks and uncertainties are described in our annual report on Form 10-K, which has been filed with the SEC. We strongly encourage you to review our filings. Today you’ll hear from our CEO, Terry Rosen; COO, Jennifer Jarrett; CMO, Dimitry Nuyten; and CFO, Bob Goeltz.
We’ll also be joined by our President, Juan Jaen, for questions after the prepared remarks. During today’s call, we’ll refer to slides in our corporate deck, which can be found on the Investors section of our website. With that, I’ll now turn it over to Terry.
Terry Rosen: Thanks very much, Pia, and thank you all for joining us today. We’ve really come a long way since our founding nine years ago, and I think it’s fair to say we have evolved into an integrated biopharmaceutical company. We’ve got seven molecules in clinical development, a broad late-stage portfolio, multiple mid-stage clinical trials, a robust discovery engine, and now something I think new, a line of sight to commercialization. With $1.2 billion in cash and equivalents in runway into 2027, we’re well positioned to deliver on the promise of the late-stage pipeline that we’ve built. We start three new registrational trials. We’re going to continue to invest in our early-stage programs. We also have a partnership with Gilead, as well as collaborations with Taiho, Exelixis and AstraZeneca.
And I think it’s very fair to say without these partnerships and the resources that these companies provide, we would not be able to execute on everything that we’re doing. All of our programs target markets that are massive and really are the sweet spots of large pharmaceutical companies. All comer patient populations in lung cancer, gastric cancer, pancreatic cancer and renal cell carcinoma, RCC. Our funding and partnerships enable us to not only pursue these settings, but to compete and compete effectively and aggressively. We’re really doing what we’re saying we’re doing. We also continue to build for the long-term with a broad pipeline of potential best-in-class and first-in-class product candidates that will continue to replenish organically with our drug discovery engine.
Today, we have three advanced clinical stage programs, dom plus zim, our FC-silent anti-tigit, it’s very differentiated molecule in our anti-PD-1 antibody, quemli, our small-molecule CD73 inhibitor and AB521, our HIF-2alpha inhibitor, which is as of today known by its generic name, casdatifan or cas. Dom/zim is in Phase 3 and we expect to initiate Phase 3 studies for both Cas and quemli by early next year. So we have four molecules, all with distinct mechanisms in Phase 3 in 2025. We also have some exciting data sets come in the first half of this year for another molecule, and these really are exciting. Etruma, that’s our A2 receptor antagonist and it’s [technical difficulty] Gilead believe support further investment in the molecule.
We made a lot of progress across all these programs in 2023, presenting two large data sets for dom/zim and two different cancers, and another large data set just last month for quemli in pancreatic cancer. I want to start today by reviewing these programs and data sets. I’ll spend a few minutes on the recent Gilead partnership updates and finish with some new data for Cas, our HIF-2alpha inhibitor. So starting with our anti-TIGIT program, dom/zim. Our primary competitors in the space are Merck and ROTH. We have the only FC-silent anti-TIGIT antibody in late-stage clinical development. So with dom’s potentially best-in-class profile, its optimized dosing regimen, as well as a broad development program focused on lung and gastric cancers, we’re really in a very strong competitive position.
Our conviction in dom/zim supported by two data sets that we presented in the last twelve months and are summarized on Slide 9 of our corporate deck. First, at ASCO last year, we presented data from our randomized Phase 2 ARC-7 study showing a PFS hazard ratio of 0.67 for dom/zim relative to zim monotherapy and first-line PD-L1 high non-small cell lung cancer. We also presented data from our Phase 2 EDGE-Gastric study where we evaluated dom/zim plus chemo in first-line upper GI cancers at the ASCO Plenary session in November. These data demonstrated impressive six-month landmark PFS rates of 93% in PD-L1 high patients and 77% overall. This really compares quite favorably to the historical benchmarks for anti-PD-1 plus chemo that are in the 50% to 60% range.
Our development program for dom/zim is focused on settings where we have the best chance to be a market leader. Today we have three Phase 3 trials enrolling, and we expect both STAR-121 and STAR-221, our chemo combo trials in PD-L1 all comers, the first-line non-small cell lung cancer and upper GI cancers, respectively to complete enrollment this year. In fact, we can share now today that we anticipate STAR-221 will be fully enrolled by the middle of this year. Due to the extremely rapid enrollment of STAR-221 and relatively short OS for the standard of care, we expect STAR-221 to be the first of our Phase 3 trials to read out. And importantly, with no other Phase 3 trials ongoing with the anti-TIGIT antibodies in this setting, we expect to have a significant first-to-market advantage.
Meanwhile, we continue to invest in the expansion of our dom/zim program. We and Gilead will initiate STAR-131, which will evaluate dom/zim plus chemo in perioperative lung cancer. This is an exciting early-stage and potentially curative setting. We also expect to initiate a four Phase 2 study in a setting outside of lung and GI cancers. Beyond our dom/zim program, today, we’ll be sharing data from the dose escalation phase of our ARC-20 Phase 1b trial of Casdatifan or AB521. The 100 milligram expansion cohort of ARC-20 enrolled quickly, and it completed enrollment ahead of schedule, November of last year. Later today, we’ll touch on what we’re seeing so far in these data. The competitor here is Merck, with their HIF-2alpha inhibitor, belzutifan, which was just improved for advanced clear cell RCC.
But we believe that Cas has a best-in-class profile, and that’s addressing a very well recognized limitation of belzutifan. What we’ve seen thus far in ARC-20 has given us confidence that our molecule has a superior profile to that of belzutifan. We’re advancing Cas rapidly and are on track to initiate a Phase 3 study early next year. And last for quemli, our CD73 inhibitor, we presented overall survival data in pancreatic cancer from our ARC-8 study at ASCO GI last month. With a large pool of data set, 122 patients, we showed 15.7 months median overall survival for quemli plus chemo, both with and without zim. This compares to the median OS from historical gem/nap-paclitaxel studies 9 to 11 months in first-line pancreatic cancer. We also conducted a matched Synthetic Control analysis that showed a statistically significant improvement in OS with a hazard ratio of 0.63.
Based on the strength of these data, we’re on track to initiate a Phase 3 pancreatic cancer trial by early next year. With Gilead’s equity investment in January, we had approximately $1.2 billion of cash on hand and we’re really well capitalized to support the breadth of programs that we are pursuing. At a high level, Gilead’s investment accomplishes two things. First, it provides us with runway into 2027, while enabling us to fund Phase 3 programs for four different molecules. Second, it enables us to fund our pre-commercial activities, and on the other end of the spectrum, to continue supporting our robust discovery engine. I’d like to turn things over to Jen right now to spend a few minutes on the details.
Jennifer Jarrett: Thanks, Terry. Gilead invested $320 million by purchasing our stock at $21 per share, which represented an effective premium of nearly 40% to our share price just before the announcement, increasing their ownership to 33%. In parallel, Gilead’s Chief Commercial Officer, Johanna Mercier, joined our Board. Her addition increases our board membership to three, provides representation commensurate with their ownership, and bring a very experienced commercial perspective to the Arcus board. The investment falls for two dynamics. One, the expansion of our late-stage clinical development plans and two, the extension of our cash runway into 2027 and through multiple data events. Concurrent with the investment, we made a few strategic portfolio changes related to dom/zim and quemli.
First, for dom/zim, we closed enrollment of our Phase 3 ARC-10 study evaluating dom/zim and PD-L1 high non-small cell lung to focus our resources and capital on areas with the highest unmet need and greatest market opportunities. A [seminal] [ph] factor that drove our decision was the evolution of the lung cancer treatment paradigm toward increased use of anti-PD-1 plus chemo for patients with PD-L1 high expressing tumors. Therefore, we believe this segment of the patient population is best addressed by our STAR-121 study, our chemo combination study, and PD-L1 all comer non-small cell lung cancer. The clinical trial landscape for PD-L1 high lung has also become increasingly crowded with several anti-TIGIT and other investigational therapies, and we were not expected to be first or second in the PD-L1 high chemo free setting.
At closing ARC-10, we are now able to focus our energy and resources on rapidly completing enrollment for STAR-121, which is addressing a much larger market opportunity. We’ll also initiate a fourth Phase 3 study for dom/zim, STAR-121, a potential first-to-market opportunity. Second, for quemli, we announced that Arcus will be operationalizing and funding a Phase 3 study evaluating quemli in pancreatic cancer. Gilead retains an option to the pancreatic cancer program with the opportunity to pay a premium to their share of the Phase 3 costs in the future. While Gilead is not co-funding this study, as you might imagine, they are aware that proceeds from the investment will be used to fund the study. I’ll now turn it back to Terry.
Terry Rosen: Thanks, Jen. Now, I’d like to switch gears to Cas, our HIF-2alpha inhibitor. This year is essentially going to be a coming out for this program as we’re planning to release a lot of new data as well as more information on our future development plans. We believe that by hitting the HIF-2alpha target harder than Merck’s belzutifan, we can improve outcomes for patients. We’ll discuss the pharmacokinetics and pharmacodynamics that support this thesis in more detail shortly, but I’d like to start with the potential areas for differentiation versus belzutifan. Belzutifan was recently granted approval of monotherapy in third-line clear cell RCC after just a three-month FDA review process. This really validated the mechanism and highlighted the high unmet need for new therapies in this market.
In Merck’s Phase 3 LITESPARK-005 trial, Belzutifan showed an improvement in PFS over everolimus, with a statistically significant hazard ratio of 0.74, which supported its approval. While these results are absolutely encouraging, the study reveals multiple opportunities for a new agent to prove upon Belzutifan’s profile and provide even more benefit to patients. First, on clinical efficacy in LITESPARK-005, Belzutifan had a high rate of primary progression, specifically a 34% PD rate, which was actually higher than that of the everolimus control arm at 22%. This means that over one-third of patients on belzutifan progressed at or before their first scan. We believe that casdatifan could stabilize tumor growth faster, resulting in a lower PD rate and therefore, longer PFS.
Second, with an overall response rate of 21.9% in LITESPARK-005, we believe there is room for improvement. Third, while LITESPARK-005 showed a statistically significant PFS hazard ratio, the median PFS was only 5.6 months. Cas may result in more durable tumor stabilization or shrinkage, and therefore longer medium PFS. Fourth, and this is an important fourth, we believe there’s an opportunity for a better tolerated combination regimen. Belzutifan’s TKI partner in earlier line ccRCC studies is lenvatinib, which is perceived, and it’s really is perceived that way, to be less well tolerated relative to other TKIs such as Cabo and Zanza. Last, we are being very thoughtful in our development strategy for Cas and we’ll focus on settings and combinations where we believe we can be first-to-market or differentiated relative to Belzutifan, and you’ll hear more about this over the course of the year.
As you may know, Merck is now projecting that Belzutifan has blockbuster potential. Given the opportunity, we’re pushing this program as hard as possible. And while our data will be more mature later this year, we want to share as much as possible today to illustrate why we’re so excited about this program. I’ll now turn things over to Dimitry to share new data from our ARC-20 trial evaluating Cas in cancer patients.
Dimitry Nuyten: Thanks, Terry. I’ll start by turning to Slide 29 of our corporate deck, which shows design of the trial, including both the dose escalation phase and expansion cohorts. The dose escalation portion enroll patients with any advanced solid tumor, while the dose expansion cohorts are only enrolling patients with second-line or later clear cell RCC. There are three expansion cohorts, each of which will enroll 30 patients. The first evaluated are go-forward dose of 100 milligrams per day and completed enrollment in November. To satisfy the FDA’s requirement for dose optimization, we are also evaluating a 50 milligram dose cohort and another cohort at a higher dose than 100 milligram in the expansion phase. Enrollment of the 50 milligram cohort is nearing completion.
Collectively, these expansion cohorts will generate a lot of valuable safety data and efficacy data in clear cell RCC patients. The dose escalation portion employed a three-by-three design, where three patients received 20 milligrams, followed by three patients who received 50 milligrams and then three patients who received 100 milligrams all daily dosing regimens. The safety results of our healthy volunteer trial enabled us to start in ARC-20, our patient trial at a relatively high and pharmacologically relevant dose, and we saw no dose limiting toxicities, allowing us to complete the dose escalation phase with only nine patients. We subsequently backfilled the 50 milligram dose cohort with three additional patients, resulting in 12-patient data set for this portion of the study.
Of the 12 patients, four patients had clear cell RCC. Slide 30 is important and shows data for Cas and Belz on EPO reductions, the peripheral or normal tissue biomarker for HIF-2alpha inhibition. On the left-hand side, the dotted line shows the EPO reductions reported for the 120 milligram or the approved dose of Belzutifan in clear cell RCC patients. In contrast, Cas achieves the same level of EPO suppression at just 20 milligrams, showing here with a purple line and that is one-fifth of our go-forward dose of 100 milligrams. This means, that 20 milligrams is roughly equivalent from a PD perspective to the approved dose of Belzutifan and therefore, 100 milligrams of Cas has the potential to achieve a meaningfully greater HIF-2alpha inhibition.
On the right-hand of the Slide, you can see that Cas has a linear, almost perfect dose proportional pharmacokinetic profile. In addition, CAS has a half-life of approximately 21 hours and this enables daily dosing. Slide 31 emphasizes the ideal PK of Cas relative to that of belzutifan, and it explains why belzutifan cannot simply be dosed higher to achieve greater HIF-2alpha inhibition. On the right for Cas, we show that we increased the dose from 20 to 100 milligrams at steady state and we observe roughly 5 times increase in exposure. By comparison, as you can see on the left, when Belz dose was increased from 120 to 240 milligrams, the drug exposure only increased by about 30% at steady state. A 30% increase in exposure is less than the typical patient-to-patient variability at any given dose and therefore is not a clinically meaningful increase.
This illustrates why dose is higher than 120 milligrams of belzutifan are unlikely to result in meaningfully better clinical activity, and, in fact, this was demonstrated by Merck in the Litespark-013 trial comparing the efficacies of 120 milligrams and 200 milligrams of belzutifan. In summary, these data show exactly what we have been predicting, that Cas has a best-in-class PK/PD profile which should result in hitting the target harder and potentially in greater clinical activity relative to belzutifan. Turning now to safety. On Slide 32, we showed the reductions in hemoglobin levels at various doses of Cas relative to the approved dose of belzutifan. Hemoglobin reductions appeared to plateau at doses above 50 milligrams for Cas, likely due to compensatory mechanisms.
And you can see that 100 milligrams daily of Cas resulted in similar reductions of hemoglobin as belzutifan, despite the fact that we are achieving higher doses, much higher doses of potency corrected drug exposure for Cas. For this reason, we expect Cas’s safety profile to be manageable and not meaningfully different than Belzutifan. On the next slide, Slide 33, we show the AE profile so far in the dose escalation phase of the study. Anemia and hypoxia are expected on target toxicities related to HIF-2alpha inhibition, while we are watching very closely that with a median follow-up across all dose levels of the escalation of about 8.8 months so far these rates do not appear to be higher than the rates seen with belzutifan in historical clinical trials.
These data demonstrates that while we believe that we are hitting the target harder, Cas appears to have a similar safety profile to that of belzutifan. So let me tie this together. We are effectively able to deliver an exposure to Cas that is fivefold greater than that which achieves the same level of inhibition of the peripheral biomarker for HIF2alpha blockade, associated with the approved dose of belzutifan, with no apparent differences in safety profile. While efficacy was not the objective of the dose escalation phase, particularly given the advanced stage of patients and the difference doses evaluated and the different tumor types included on Slide 34, we do summarize what we observed in RCC patients, specifically clear cell RCC patients.
As I mentioned earlier, there are four patients spread across the three different dose levels we evaluated 20 milligrams, 50 milligrams and 100 milligrams. These are all late-line patients with a variety of prior treatment regimens, including at least one anti-VEGF treatment and one anti-PD-1 treatment. Three out of four patients are actually fourth-line or later, and for these four RCC patients, two had meaningful tumor reductions just short of 30% and the third patient did not experience any tumor growth for over 14 months and still remains on treatment. The time on treatment is impressive for these patients in very late-line setting, ranging from 8.5 to 14.5 months, and two of the four patients still remain on treatment. This indicates the potential of very durable effects of Cas, even with monotherapy in a very advanced patient population.
We are also seeing signs of Cas’s ability to bring even aggressive tumor growth under control. For example, one of the four patients I mentioned, was very heavily pre-treated, had received three prior VEGF-TKIs and an anti-PD-1 treatment, and this patient had stable disease early on with slight increase in tumor volume, not meeting formal progression for RECIST, and after about 18 months, the tumor volume started to come down and now, after about 10 months and still ongoing on treatment, the patient is nearing a response. I would like to emphasize that while the primary goal of an all comer dose escalation study is to establish the safety profile and assess the pharmacokinetics and pharmacodynamics, we have already seen clear signs of antitumor activity in patients with advanced clear cell RCC, and we believe that tumor shrinkage and the duration beyond one year for patients who have exhausted all available treatment options are very clinically meaningful.
The ongoing expansion portion of the phase is designed to give us a better read on efficacy, and this is already providing clear support for the initial observations in the dose escalation phase. And I would like to make a few comments on the early data of the expansion portion of the study. The 100 milligram cohort has completed enrollment in November, so we have a mature and rich data set in hand for 30 clear cell patients treated at 100 milligrams of Cas. While these data are still early, we are already seeing glimpses of Cas’s potential for differentiation over belzutifan. We’ll share the full data set at a medical conference later this year, but we did feel it was important to share some highlights of the data today. First, the majority of patients in the expansion cohort have only had one or two scans, and we scan patients approximately every six weeks, so it’s about one and a half to three months of follow-up.
Nonetheless, even with this very short duration of follow-up, the response rate we are seeing, which includes unconfirmed responses, given how limited the follow-up time is, it’s already in line with the response rate seen for Belzutifan in LITESPARK-005. We also have a substantial number of patients early on their treatment who have experienced tumor shrinkage but have not yet crossed the formal threshold of 30% to meet a response. But this obviously can happen with longer duration of treatment on future scans. Secondly, we are seeing a relatively low primary progression rate, and this is the percentage of patients whose best overall response is progressive disease. So these patients have tumor progression on the first scan. This may indicate that Cas’s ability – sorry, Cas can stabilize tumor growth early on during treatment, and this will be an important parameter to monitor in the future as it represents an opportunity to prove upon something that was reported for Belzutifan.
In summary, we are very encouraged by these early dose escalation and expansion cohort data, which, while early, have provided an encouraging signal that Cas’s PK/PD profile could translate into greater efficacy in the clinic. By midyear, we will have a minimum of seven months of follow-up for all 30 patients in the 100 milligram expansion cohort, which should provide a mature look at the overall response rate and we expect to present these data at a medical conference in the second half of the year. As I mentioned earlier, ARC-20 includes two additional expansion cohorts and we – expect this to also be presented over the next 12 to 18 months. We also expect data from STELLAR-009, our study evaluating Cas together with Zanzalintinib, sorry, also referred to as Zanza, sometime in 2025.
We are full speed ahead to our Phase 3 study and we expect to disclose more on our development plan in the coming months. Terry will outline our other catalysts for 2024, but first, I will turn things over to Bob to discuss our fourth quarter and full year financials.
Bob Goeltz: Thanks, Dimitry. As Terry outlined earlier, Arcus continues to be in a very strong financial position. Our cash as of December 31st, 2023 was $866 million and increased to $1.2 billion after Gilead’s January equity investment. Importantly, our partnership with Gilead is very capital efficient, because we share the majority of costs for optioned programs 50:50, including multiple Phase 3 studies for dom/zim. Gilead has also committed to pay the $100 million option continuation payment due in July under the collaboration agreement. So we expect our cash balance at the end of 2024 to be between $870 million and $920 million, and now expect our cash to fund operations into 2027. This guidance excludes other potential opt-in payments and approval milestones from our partners.
Turning to our P&L, we recognized GAAP revenue for the fourth quarter of $31 million, which compares to $32 million for the third quarter of 2023. Our revenue is primarily driven by our collaboration with Gilead, and we are evaluating the impact of the recent amendment on our revenue for 2024 and beyond. In addition to our partnership with Gilead, we have a partnership with Taiho for dom in Japan. In the fourth quarter, we received a milestone payment of $14 million from Taiho related to their participation in our STAR-221 pivotal study and will receive another $30 million in the first quarter of 2024 related to their participation in our STAR-221 and STAR-121 pivotal studies. We are also eligible for additional milestone payments of $10 million in the first quarter of 2025 from Taiho related to STAR-121.
Our R&D expenses for the fourth quarter are stated net of reimbursements from Gilead and we’re $93 million as compared to $82 million in the third quarter of 2023. In the fourth quarter, non-cash stock compensation represented $9 million of our R&D expenses. The increase in the fourth quarter was related to standard of care purchases for our clinical trials. We continue to expect modest increases in R&D expenses as our Phase 3 studies mature, and spend will fluctuate primarily based on the timing of clinical manufacturing activities and the purchase of standard of care therapeutics for our clinical trials. G&A expenses were $29 million for the fourth quarter of 2023, compared to $30 million in the third quarter of 2023. Non-cash stock compensation represented $9 million of our G&A expenses for the fourth quarter, and we expect G&A to remain stable for 2024.
For more details regarding our financial results, please refer to our earnings press release from earlier today and our 10-K. I’ll now turn it back to Terry for concluding remarks.
Terry Rosen: Thanks very much, Bob. Before we open the floor to questions, I’d like to briefly touch on upcoming catalysts for 2024 beyond the ARC-20 data sets that Dimitry highlighted. There’s a lot. This will be another data rich year for Arcus. For the anti-TIGIT program, we’ll be presenting updated data from EDGE-Gastric, our Phase 2 study evaluating dom/zim plus chemo in Upper GI cancers at ASCO this year. We expect this data set to include updated ORR and PFS data. We also look forward to announcing the completion of enrollment for STAR-121 one and STAR-221, which will obviously start the clock for potential regulatory filings. We also may share data and insights from ARC-10 at a future medical conference. As I mentioned earlier, we presented impressive overall survival data from our Phase 1b ARC-8 trial that was evaluating quemli in first-line pancreatic cancer.
Also related to the adenosine pathway, we have two randomized data sets that we expect to share in the first half of the year for Etruma, our A2 receptor antagonist, and we believe these confirm our findings in ARC-8 that adenosine modulation confer profound improvement on overall survival. So first off, Roche will be presenting data from MORPHEUS-PDAC. This is a randomized study, operationalized by Roche that evaluated Etruma in combination with chemotherapy and atezo, their anti-PD-L1 antibody versus chemo and pancreatic cancer. So, a randomized study that involves Etruma. Second, we submitted data from the third-line cohort of ARC-9 for presentation at a medical conference. This cohort enrolled 105 patients and evaluated Etruma plus zim plus bev and FOLFOX versus rego, the current standard of care in third-line colorectal cancer.
The presentation will include mature PFS and, importantly, OS data, which we believe are also very supportive of the potential for adenosine modulation when combined with immunogenic chemotherapy to robustly, we mean, robustly, prolong PFS and OS. So, in conclusion, we’ve covered a lot today, a lot of material, but there’s one thing to take away from today’s call, it’s that Arcus is now fully enabled to execute on its diverse, late-stage portfolio with funding into 2027 and that excludes potential future opt-in payments. Our portfolio includes six ongoing and planned Phase 3 trials, multiple Phase 1 and 2 studies, and a discovery engine that’s just capable of generating at least one IND per year. Our trials are focused on huge markets by any standard, lung and GI cancer, pancreatic cancer and RCC, where we’re extremely well positioned to compete with potential first-to-market or best-in-class therapies.
We have a lot going on, I think a lot more to come this year. Thanks for your interest and support for Arcus as we continue to broaden our portfolio of innovative combination cancer therapies, and we’re working to bring these treatments to patients as soon as possible. We’ll now open the floor to questions.
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