US
Biotechnology
Questions
for
Management
North America Equity Research 08
September
2020
With virtual broker conferences starting up again as we wave goodbye to summer
(what
summer?),
we
have
updated
our
list
of
key
questions
for each company in our coverage universe. Questions are listed by company and organized by market cap, in alphabetical order. These questions are by no means exhaustive but are meant to serve as a guide for the onslaught of upcoming management meetings. We‟ve also numbered our most pressing questions for management within each list. Covered companies: Large Cap Companies: ALXN, AMGN, BIIB, BMRN, GILD, INCY, REGN, SGEN, VRTX; SMID Cap Companies: ACAD, ACOR, ALKS,
ALLO,
BLUE,
BNTX,
CLVS,
EDIT,
GBT,
GWPH,
JNCE,
LEGN, MRNA, NVCR, PBYI, RARE, SAGE. Please note questions for management can also always be found in our monthly Catalyst Database along with a comprehensive list of company specific events (among other information), in an easy to read PDF format.
Biotechnology
–
Large
Cap Cory
Kasimov
AC
(1-212)
622-5266
cory.w.kasimov@jpmorgan.com Bloomberg
JPMA
KASIMOV
<GO> Matthew
T
Holt,
Ph.D.
(1-212)
622-9602
matthew.t.holt@jpmorgan.com
Gavin
Scott
(1-212)
622-0579
gavin.scott@jpmorgan.com
Turner
Kufe,
MD
(1-212)
622-4104
turner.kufe@jpmchase.com
J.P.
Morgan
Securities
LLC
See page 28 for analyst certification and important disclosures. J.P. Morgan does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. www.jpmorganmarkets.com
Alexion (ALXN; $108.19; OW): Bigger Picture #1. What is the company"s stance on competitive (both branded and biosimilar) risks over the foreseeable future – particularly on the PNH front? Is ALXN confident with how the pipeline stands or is there appetite (& capacity) for additional BD on the heels of the ACHN and recent PTLA deals?Complement Franchise Can you discuss the pushes/pulls of the accelerated conversion rate observed during 1H20 as a result of COVID-19 and potential impact in 2H20? #3. Is there anything different in the PNH market that would suggest a different conversion rate in the aHUS market? #2. What is your view on interchangeability with respect to biosimilar adoption and could this give a biosimilar a label that encompasses all of the approved Soliris indications despite a large phase 3 trial in say PNH alone? What is the sales/marketing rep distribution in the context of 1) call point (academic vs community) 2) geographic (US/EU/Japan) 3) specialist (Neuros vs hematologists)?
Can you provide clarity on ex-US pricing for Soliris/Ultomiris? How do you expect uptake to evolve in gMG given off-label Rituxan/Rituxan biosimilars or are most patients Rituxan experienced/failures? Are you seeing a different dynamic play out between the US/EU markets? Furthermore, it seems that ~200-300 patients per quarter are being added on to Soliris within Neurology. Can you discuss this dynamic and should we expect a linear trend here or if/when should we expect it to moderate? When should we expect data in ALS (dosed first patient in 1Q20)?Pipeline and other #4. What are the key levers that need to be pulled in order to unlock value from the recently announced PTLA acquisition? How receptive are patients to sc dosing (in the clinical trials) in the context of “fear of needles” and how might this translate to the real-world setting? What size needle is used? Will there be an auto injector option for Ultomiris? Can you provide updated thoughts on Wilson‟s disease? What are the key efficacy measures you are looking for (data now expected 1H21)? Can you broadly explain the C5 bispecific program and when do you expect clinical data for this program?Financials #5. Curious to get your general views on operating margin progression going forward? Is there an opportunity to expand beyond 2020 guidance of 55-56%? Thoughts on healthcare reform proposals and what level of exposure does ALXN have in the government channels which could potentially be affected?
If there is a large demand for sc dosing, what impact will this have on COGS?
Amgen (AMGN; $241.18; N): Bigger Picture Given some industry consolidation how to you expect the M&A market to evolve from here, especially given the mix of low interest rates yet relatively rich valuations? #2. How do you balance geographic mix shift (increased presence in Asia, specifically) with maintenance of your overall corporate margin profile (esp. in light of COVID-19 fears)? How is AMGN positioned to mitigate HC policy headwinds should some of the recent pricing proposals (i.e., “most favored nations”) be implemented?Immunology #3. Now that the District Court decision is behind us, what strategy is AMGN implementing to mitigate Enbrel"s tail risk (i.e., how sustainable are continued price increases)? What is the OUS commercial strategy for Otezla given limited sales in these geographies to date? Can you remind us of the OUS IP expiry? How do you expect the commercial strategy within Immunology to evolve and does this involve investment in novel molecules or a reliance on your biosimilar portfolio?Aimovig When should we expect CGRP volume trends to normalize? Do you expect an impact from oral CGRP‟s? Can you provide any visibility on persistence within the CGRP market and updated thoughts on peak sales potential for the class and/or Aimovig? What drove the decision to terminate the Neuroscience program at AMGN? Was this due to a scarcity of potential projects with acceptable risk/reward profiles or coming though the cost management lens?Pipeline and other #1. What are your expectations (in terms of duration of response/PFS) for the ph 2 potentially pivotal AMG 510 study in NSCLC? Do you ultimately expect sotorasib to compete in the 1L (in combo with PD1/L1) or as a 2L standard of care? What is the path forward for AMG 510 in CRC now that we have seen data presented at ASCO? Is there a path forward for monotherapy or is this likely a combo market? Are there updated thoughts on the BCMA programs – What should we expect from AMG 701? What are expectations for TSLP in Asthma and what differentiates this drug from others in this market?Financials #4. How has the pace of BD been impacted by the Otezla acquisition and BGNE collaboration? Given the low interest rate environment, how do you think about leveraging the balance sheet for additional bolt-ons? What size of a deal is still considered a bolt-on? #5. Given recent share repurchase commentary, how does AMGN prioritize share repo"s vs dividend growth? Non-GAAP operating margins were ~53% in 2018; how should we think about this in terms of peak margin potential for the business?
Biogen (BIIB; $268.90; N): Bigger Picture #5. How would you categorize BIIB‟s balance of risk and opportunity in the pipeline and what are some ways to mitigate that risk, especially if adu does not get approved? Given the various drug pricing reforms on the table, how is Biogen positioned in the event that some of the pricing proposals are ultimately implemented?Alzheimer’s disease #2. What has been the KOL feedback post the presentation of the Phase 3 EMERGE and ENGAGE studies at CTAD and the clinical meaningfulness of the data? #1. Walk us through the key review levers for aducanumab in Alzheimer‟s. Has FDA indicated in any way what dataset(s) they plan to focus on the most during the review? What discussions have you had with regulatory agencies ex-US, and what is their receptivity to reviewing an application for aducanumab? Do you have any open-label or long-term extension data from ENGAGE and EMERGE, and if so, what do those data show? Is there an updated data disclosure strategy for 2020 while aducanumab is under review? Given concerns around ARIA-E, what post-marketing monitoring requirements would you expect to have (i.e., REMS program)? #4. How does the adu Ph3 findings impact your thoughts on BAN2401? How are the molecules different; could „2401 actually see better results given no need for titration? Why was BAN2401 chosen for the Phase 3 pre-symptomatic Alzheimer"s study? What is Biogen‟s strategy in targeting AD between the anti-Aβ and anti-tau assets? Can you go into detail about how your recently announced collaboration with SGMO fits into this?Multiple Sclerosis (MS) #3 How should we think about the opportunity for Vumerity after the Tecfidera patent loss? How confident is the company in a successful appeal, and what would a loss in Delaware mean for the franchise?Spinraza What are the market dynamics between Spinraza and Zolgensma? Are they being used together in the real world, or are pts discontinuing Spinraza for Zolgensma? What are you doing to increase Spinraza penetration into Type II and III patients? What type of impact do you expect an oral option to have on the SMA market? How has your understanding of the SMA market evolved since launch of Spinraza and what can you do to maximize the opportunity in SMA overall?Other Pipeline How are you thinking about the ophthalmology commercial infrastructure buildout? What therapeutic adjacencies are you considering outside of immunology when it comes to expanding the pipeline?Financials When looking at BD opportunities, how can you execute on risk mitigation strategies while ensuring you aren‟t overpaying for external opportunities?
What is Biogen"s current deal-making capacity and appetite for bringing assets in house? Has this changed with adu‟s revival?
BioMarin (BMRN; $74.49; OW): Bigger Picture #1. Can you provide your updated view on healthcare policy in the context of pricing and reimbursement? How might any of the proposals impact valrox pricing strategy? How would a value-based pricing agreement for Roctavian look in your eyes? Thoughts on BD/licensing deals going forward?Commercial Portfolio Can you comment on the uptake of Palynziq and are there certain patient characteristics that have led to better/worse uptake? Differences btw US & EU? Can you discuss patient conversion in the context of Kuvan and Palynziq? What % of patients are administered both drugs? Can you discuss Vimizim sales trends and is there still an ongoing effort on patient identification/diagnosis? When should we expect this to moderate (from a total $ spend point of view)?
Can you provide clarity on US/OUS pricing and how this dynamic is expected to evolve?
#2. Where are you with respect to commercial readiness for valrox and vosoritide (assuming approval)? What is your expectation for EU valrox approval?Pipeline and other #3. How might the vosoritide regulatory review be impacted given the current environment and what are key risks that could potentially surface during the review process? What are the key drivers of physician acceptance of vosoritide; and pushback? #4. Can you comment on the cadence of data disclosure for valrox given the recent regulatory setback (i.e. will the one year phase 3 data be presented or will you wait for 2-year results? Do you expect capacity constraints for valrox adoption, what are you doing to mitigate this bottleneck and does this differ between US and EU? In terms of gene therapy innovation, where do you see the greatest weakness/opportunity for optimization? What other indications do you see an opportunity to leverage your gene therapy know-how?Financials #5. Where should we expect COG margin to fall for gene therapy relative to other products in the portfolio? How do you see R&D spend evolving in the near-to-mid-term given the potential launch of two new drugs next year? Can you broadly walk us through the path to profitability / how dependent is this on expense management?
Incyte Corporation (INCY; $89.73; N): Bigger Picture What are your latest views on business development to either gain access to more disruptive products and/or technologies or to facilitate further global expansion?Jakafi #2. For your long-term guidance for Jakafi ($2.5-$3B), can you talk about what sort of assumptions went into this? How would you describe the commercial progress being made with the product and expectations in the near-to-medium term within MF, PV and acute GVHD? After positive REACH3 data in chronic GvHD, can you talk about the incremental market opportunity in the indication, relative to currently approved indications? Can you provide an overview of the LIMBER programs, and which of the four (PI3Kdelta, PIM, BET and ALK2) are you most excited about? Later this year we should be getting bioavailability and bioequivalence data for your once daily formulation of rux. What does it mean for the franchise if you"re able to show promising results here, and what would the logical next steps be?Pipeline and other Can you provide some color regarding the ongoing launch for Pemazyre and thoughts on long-term potential for that product? And how should we think about the bladder opportunity given competition (i.e., Balversa or Padcev)? #1. What pipeline candidate do you think has the best chance at driving a renewed interest, or something that could materially change the outlook for Incyte? On cGVHD, can you talk about the differences between ruxolitinib and itacitinib and the benchmark for success with itacitinib in the GRAVITAS 309 program? How should we think about the potential for pemigatinib in the tumor agnostic study in terms of the benchmarks for safety / efficacy and market opportunity? #4. Can you elaborate on the launch plans in Europe, and how much you"ll have to expand your footprint there to commercialize tafasitamab? What‟s next for tafa in terms of ongoing studies and readouts? How do you best maximize the potential of this asset? #3. Can you walk us through the opportunity for topical rux in both atopic dermatitis and vitiligo? How is topical rux differentiated in atopic dermatitis specifically? How receptive do you expect payers to be to reimbursing a product for vitiligo? #5. With regard to the future commercialization of topical rux, what are your latest thoughts with regard to your overseas strategy? On the oral PD-L1 you have in development, what are your thoughts on the market opportunity and the level of efficacy needed to show with an oral vs. an antibody in order to receive regulatory approval?Financials What are your thoughts in regards to capital allocation and the level of R&D spend / opex we should expect in the next few years? How much does the Jakafi LOE play into your current strategic planning?
Gilead (GILD; $64.14; N): Bigger Picture #1. What is GILD‟s relative appetite for BD around single assets vs. acquiring platforms? What is the latest in regard to specific disease areas / indications? How does Gilead think about potential deals across the small-to-mid-cap spectrum as well as commercial vs. clinical stage companies? Can you discuss your recent M&A/BD transactions in immuno-oncology and how this fits into the company‟s strategic vision?COVID-19 Can you outline the current clinical data for remdesivir and what data updates we might expect in the near term, if any? #1. What"s the long-term strategy with remdesivir? How much of a commercial focus is there initially and, if COVID-19 does develop into a seasonal or prolonged pandemic, what might the opportunity be here for GILD?HIV / PrEP Portfolio #2. How does Gilead think about the HIV and PrEP markets evolving over the next 5 years given: (1) the introduction of generics; and (2) additional branded competition? #3. How does mgmt think about Biktarvy concentration risk, especially ahead of patent litigation expected in September? Any preliminary comments/thoughts you can share on that pending litigation? Out of the estimated ~1.1M candidates for PrEP, can you break down what the split is between MSM and cisgender women and other potential treatment populations? What does GILD see as the overall market potential for Descovy in PrEP? Also, can you remind what the latest is in terms of the possible patent term extensions that would move the US expiry from 2022 to 2025? How should we be thinking about Descovy growth in 2020/2021 given the strong momentum seen early in the PrEP launch (i.e., is there a bolus effect or can this early switching dynamic continue)? Is GILD doing anything to incentivize this switching? Any updated thoughts around the role that you believe doublets (including injectables) may have in the HIV treatment landscape?Pipeline and other #4. Regarding filgotinib, and on the heels of the CRL, what‟s the latest on the MANTA and MANTA-RAY studies? Can you expand on your commentary contained within the CRL that the FDA expressed concerns on the risk/benefit of the 200mg dose? More broadly, what is your strategy/how do you most effectively compete in the I&I markets against more entrenched players? On the heels of negative Phase 2 ATLAS data, what are the next steps in NASH? How does GILD view the market opportunity for Yescarta in earlier lines of treatment and how might the commercial dynamics be different to the r/r DLBCL indication? Two-plus years post the acquisition of KITE, how would you grade that transaction and how much remains up in the air given the relatively nascent nature of the cell therapy field? Does this deal inform future BD at Gilead in any way? What else in the pipeline should we be focused on?
Regeneron (REGN; $561.89; N): Bigger Picture What"s your latest thoughts on healthcare reform and the potential impact it may have on Eylea in the near-to-medium term for Medicare Part B? Also what do you see as the likelihood of potential reform impacting other parts of the business?COVID-19 What"s the latest in terms of a COVID-19 antibody cocktail? If successful, where do you see REGN-CoV2 slotting into the treatment algorithm? #1. What‟s the long-term strategy with REGN‟s antibody cocktail? How much of a commercial focus is there initially and, if COVID-19 does develop into a seasonal or prolonged pandemic, what might the opportunity be here for REGN?Eylea #2. With the noted safety risk for Beovu / brolucizumab in wet AMD, can you discuss what you‟re seeing in the field at a high level? What is mgmt‟s view on additional competition (e.g., faricimab, Lucentis port delivery, biosimilars) with data readouts expected over the next few years? Tell us more about the developmental pathway for high dose Eylea formulation following your recent announcement of plans to initiate two Phase 3 trials. What might timelines look like here?Dupixent #4. Are you able to better characterize what segments Dupixent growth is coming from across AD, asthma, and CSwNP indications? How big of a threat are JAK inhibitors to dupi in AD, and how do you think about the relative efficacy and safety profiles in this indication? What about topical vs oral? What‟s your view on the competitive landscape for dupi across its current and future indications more broadly?Pipeline (including IO) and other #3. Can you review your approach to immuno-oncology and the opportunity here? From a financial perspective, how do you think about clinical development in the IO space given all of the players, approaches, and (fast) moving parts? What is mgmt‟s plan for competing in the IO markets against entrenched players in this space? Is having comparable data vs chemotherapy enough in the PD-1 space? What is differentiated about REGN‟s bispecific platform? How does REGN1979 and REGN5458 stack up against CAR T and other bispecific therapies in the clinic so far? Specifically on your bispecific REGN1979 program, how does REGN think about the trade-offs between efficacy and safety relative to other CD20xCD3 competition? Could you help us to understand your thoughts on fasinumab data in OA, especially after the 2Q20 update, and what you ultimately want to see to be confident in the commercial potential of this product? What else in the pipeline should we be focused on?Financials Given that the pipeline is expanding rapidly and moving into areas new to Regeneron, how should we think about R&D and SG&A spend over the next few years?
Seattle Genetics (SGEN; $146.48; OW): Bigger Picture #4. What is your appetite/capacity for BD or bringing other assets in-house given all that you have going on?Padcev (EV) #2. How would you characterize the launch of Padcev relative to your initial expectations in 3rd line bladder cancer patients? How big of a sales force do you expect to have and what commercial synergies will there be with Adcetris from an infrastructure point of view? What underlies your assumptions of 2,000-4,000 3rd line patients in the US? #3. What was the KOL feedback on the EV-103 data presented for EV in combo with pembro at ASCO-GU? With the collab with Merck, what are the timelines for (1) the completion of enrollment of Cohort K in the „103 study; and (2) the Phase 3 trials? When might we get an update from your basket study evaluating Padcev in other Nectin-4 expressing tumors? Given there are a number of other assets under development for bladder cancer, how do you think EV will ultimately be positioned if all these agents are available?Tukysa (tucatinib) #1. Can you help frame the launch strategy in HER2+ breast cancer given both the competitive market as well as launching the product during the COVID-19 pandemic? What are the timelines for earlier breast cancer studies with tucatinib? What about in other HER2+ cancers? Essentially, what is the most effective way to meaningfully expand this market over time?Adcetris Can you provide any qualitative / quantitative commentary on the potential impact that the international pricing index proposal would have on Adcetris pricing? Specifically for frontline HL and the E-1 trial, how should we be thinking about the timelines to OS maturity or the impact of other surrogates (such as 5-yr PFS)? What are you seeing in the real world as far as the average number of cycles in both the E-1 and E-2 patient populations? How do you think this translates into the ultimate commercial opportunity for the drug? For a bigger picture outlook on Adcetris, what do you see as the market opportunity for this drug across indications 3-5 years down the road? Has it changed at all from how you previously thought about this?Pipeline and other Can you talk a bit more about the opportunity for TV in cervical cancer and where you see TV ultimately positioned within the indication? What are you looking for in the upcoming pivotal data readout? Any other earlier stage programs that you‟d like to flag or highlight?Financials How important are bottom-line results at this point in SGEN‟s evolution? How do
you think about balancing the growing top-line with investing in the business / R&D?
Vertex Pharmaceuticals (VRTX; $258.61; OW): Bigger Picture What are your thoughts on the evolving political landscape around drug pricing and how is Vertex positioned if some of the recent proposals ultimately go through? In terms of BD/M&A, what other areas you are looking to get involved in and what are your thoughts on larger M&A opportunities?Cystic Fibrosis (CF) #1. Trikafta has obviously gotten off to a tremendous start. Can you help us understand just how much pull-through there was in 1Q and 2Q, and what that might mean for 3Q and beyond? Can you talk about how you view further growth in CF? Specifically, any gating factors to the sNDA submission for 6-11 year olds; impact from COVID-19 to label expansions, etc.? Can you discuss your expectations for Kaftrio reimbursement OUS and whether prior discussions for Orkambi and Symdeko may expedite Kaftrio reimbursement and/or lead to a tighter pricing band for Kaftrio? How are you thinking about the rapidity of the Kaftrio uptake in the EU relative to the very fast start in the US? Can you remind us of the current clinical program underway for a once-daily triple combination and when we should see the first data from one of those programs? What is the status of the CF collaboration with Moderna and what types of programs are you working on?Pipeline What are the key differences between the two clinical AATD assets, VX-814 and VX-864? #3. What clinical endpoints do you anticipate using in registrational study for AAT, especially related to monitoring of liver and lung function in AAT? Also, do you have a sense of sizing or length of follow-up? #2. Why was the Phase 2 VX-864 study downsized from the Phase 2 VX-814 study? Was this due to enrollment headwinds or a potentially positive signal emerging from „814? #5. Can you provide an overview of the T1D/Semma program, and provide context around what an initial clinical study would look like? And for VX-147 / APOL1 FSGS, you have a small ongoing Phase 2a study; when might we see data and what are you hoping to show? What gives you confidence in the approach you"re taking with CTX001 in SCD and beta-thal with CRISPR and how is this approach differentiated from other therapies?Financials #4. Given that the pipeline is expanding rapidly and into areas new to Vertex (i.e., ex- CF), how should we think about OpEx and margins over the next few years?
Acadia Pharmaceuticals (ACAD; $38.20; OW): Bigger Picture #1. In your view, what is the biggest potential risk to the sector and what is ACAD doing to mitigate this headwind? Can you comment on current pricing trends and any visibility on gross-to-net going forward (i.e., what"s the trend relative to 2019)? In terms of BD/M&A, what other areas come into focus?Nuplazid (commercial) What revenue/expense trends should we expect headed into 2H20, and what is the impact in the context of the potential DRP launch? What"s the key driver for: 1) rate of Nuplazid refills; 2) increased persistence? Any specific patient characteristics that you have observed that negatively and/or positively impact this dynamic? Do you expect a long-term sustainable refill rate? How should we view persistence over time? When should we expect this to normalize? #2. What channel are you experiencing the greatest uptake and how do you see this evolving as additional indications come on line (pending approvals) and pre-COVID- 19 normalization? In your view, what are the greatest competitive threats to Nuplazid commercialization?Nuplazid (pipeline) #3. Can you frame expectations for a potential label for Nuplazid in DRP (i.e., broad vs limited to ADP given prior data in the later)? How dependent are long-term sales and the path to profitability on Nuplazid label expansion? #4. What are the gating factors for filing the sBLA off the phase 3 HARMONY readout? And do you expect an AdCom? How does age/severity/prior relapse impact the rate of relapse in DRP patients? How might the real-world setting differ from the clinical trial experience with respect to Nuplazid in DRP? Do you expect physician prescribing patterns to differ between EU and US with respect to Nuplazid for the treatment of DRP (pending approval)? Why / why not? On the heels of the positive ph 2 ADVANCE study for schizophrenia, what drives your confidence in producing consistent results in the ph 3 study?Financials Can you comment on R&D spend going forward? #5. On BD, what additional types of deals would you pursue and would this involve a clinical stage asset or potential partner for EU commercialization of Nuplazid?
Acorda Therapeutics Inc. (ACOR; $0.48; UW): Bigger Picture What is the overall long-term vision for the company given the recent restructuring announcement? What are the potential applications of the ARCUS platform? How do you plan to leverage the technology and GMP manufacturing facility given the restructuring announcement?Inbrija #1. What is the primary hurdle to uptake of Inbrija and what efforts are ongoing to eventually overcome that hurdle? How many scripts have been dispensed via the free trial program and how long will it take for those pts to turn into paid scripts? How frequently do patients cease treatment pre-transitioning to commercial pay? How long do you think it will take for physicians to start prescribing Inbrija more broadly to their Parkinson"s disease pts after initially testing the product in a few pts? What are the dynamics driving use in the low, moderate, and high OFF burden segments? Why has uptake been so much quicker in low burden pts (60% of pts on Inbrija) than in the higher burden segments in terms of pt numbers? #3. How can you drive more utilization in moderate and high OFF burden segments? For the plans where you have received a formulary agreement, what does that coverage look like and are there any major barriers to access Inbrija? Can you update us on your progress on EU partnerships, characteristics of the ideal partner, thoughts around potential in that market, and potential size of an upfront? #4. What types of assumptions underpin your peak sales projection of $800M+ for Inbrija and how do we get there from here? #5. How is Inbrija differentiated from other recent launches in the Parkinson"s disease space such as Gocovri, Osmolex, and Xadago? What about other rescue therapies such as sublingual apomorphine?Pipeline and other What is driving continued strength in Ampyra sales and how should we think about modeling Ampyra beyond 2019? Do you plan to make additional inventory purchases on Ampyra given the strength? Part of your restructuring announcement included a major cut to R&D to refocus efforts on Inbrija. Should we expect to see other pipeline assets like CVT-427 advance at this point or are all other programs on hold indefinitely?Financials On the balance sheet…what is your current cash runway and what are the key components underlying these assumptions? #2. Walk us through your recently announced debt restructuring and how this factors into your cash runway?
Alkermes PLC (ALKS; $16.21; N): Bigger Picture / COVID-19 #1. Can you more broadly speak to ongoing market shifts you‟re seeing for Vivitrol and Aristada in light of COVID-19? How would you characterize the level of disruption across your ongoing clinical trials and even your earlier stage research…anything that really stands out at this point?Vivitrol What are the bottlenecks to accessing funding at the State level and do you see this process gradually picking up pace? Do you have visibility on the number of grant applications/proposed state programs involving Vivitrol? Are you seeing any early benefits from the Albertson‟s partnership, and do you anticipate broadening out these types of relationships? What‟s the current split between opioid dependence and alcohol dependence? How are you sizing the alcohol opportunity and do you view it as a key growth driver?Aristada Are you seeing any increased adoption of the two-month Initio regimen, particularly in light of COVID-19? What type of impact are you seeing from the ALPINE data this spring comparing Aristada with Invega Sustenna? How is that resonating in the market? What are the key markets/patient subgroups Alkermes is focusing on for continued Aristada growth?Pipeline and other Can you talk about the market opportunity for ALKS 3831? Is it just for those who gain weight with olanzapine or could it be broader? Have you started talking to payers on „3831? How important do you believe metabolic parameters will be for them? How do you think about pricing „3831? Does the inclusion of the bipolar indication in the submission for „3831 change your commercialization plans for the product in terms of building out the sales force? Can you remind us of the synergies you expect to have with the current Aristada team? #2. You recently had the AdCom scheduled with the FDA for „3831, and the discussion will also include the potential clinical risks related to the interaction of samidorphan and opioids. Why was this suddenly included? What are your thoughts on the market opportunity for Vumerity in MS and what‟s the latest in terms of how BIIB is planning to market this? #3. Can you set the stage for „4230 ARTISTRY-1 data at ESMO? What would you view as encouraging and justify moving into Phase 2? When might we see ARTISTRY-2 data, and how are expectations different?Financials #4. Given that you only have „4230 in the clinic now, can you help us understand what goes into your R&D spend and why it is so high (even with the restructuring) compared to similar companies? Are there other opportunities to cut spend further?
Allogene (ALLO; $33.02; N): Bigger Picture #1. Ho...