North America Equity Research03 September 2019 US BiotechnologyQuestions for ManagementBiotechnology – Large CapCory Kasimov AC(1-212) 622-5266cory.w.kasimov@jpmorgan.comBloomberg JPMA KASIMOV Matthew T Holt, Ph.D.(1-212) 622-9602matthew.t.holt@jpmorgan.comNeena M Bitritto-Garg, CFA(1-212) 622-8967neena.m.bitritto-garg@jpmchase.comGavin Scott(1-212) 622-0579gavin.scott@jpmorgan.comJ.P. Morgan Securities LLCSee page 26 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.comAs summer comes to a close and broker conferences resume, we have compiled a 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. Covered companies: Large-Cap Companies: AMGN, BIIB, GILD; Emerging Large-Cap Companies: ALXN, BMRN, INCY, REGN, VRTX; SMID-Cap Companies: ACAD, ACOR, ALKS, ALLO, BLUE, CLVS, EDIT, GBT, GWPH, JNCE, MRNA, NVCR, PBYI, RARE, SAGE, SGEN.2North America Equity Research03 September 2019Cory Kasimov(1-212) 622-5266cory.w.kasimov@jpmorgan.com Amgen (AMGN; N)Bigger Picture#1. Given industry consolidation, how do you expect the M&A market to evolve from here, especially given the mix of low interest rates yet relatively rich valuations?How is AMGN positioned to mitigate HC policy headwinds should some of the recent pricing proposals be implemented?Enbrel#2. Now that the District Court decision is behind us, what strategy is AMGN implementing to mitigate Enbrel’s tail risk?What is the OUS commercial strategy for Otezla given limited sales in these geographies to date?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?AimovigWhen should we expect CGRP volume trends to normalize?Can you provide any visibility on persistence within the CGRP market and updated thoughts on peak sales potential for the class and/or Aimovig?#3. In the context of the broader Neuroscience pipeline, what are the most attractive markets that AMGN can extract value? Pipeline and otherCan you provide updated thoughts on AMG 510, including what an accelerated path to approval would look like? What are the gating factors (even from an historical perspective) that need to be met in order to pursue an accelerated pathway?Can you discuss the biologic rationale of a KRAS/PD1 combo strategy, and is this something that you would ultimately develop with your own PD1 or collaborate with a partner?To your knowledge, how prevalent is the KRAS G12C mutation in NSCLC, and can you provide estimates on the addressable market?Are there updated thoughts on the BCMA programs given positive late stage data in ADCs? How does the BiTE platform shake out in terms of potential commercialization? What are the gating factors in moving forward AMG420 vs.AMG 701?What are expectations for TSLP in Asthma? What have you learned from the prior atopic dermatitis trial that has informed the design of the current trial?Beyond those mentioned, what is the most exciting pipeline asset in your view?Financials#4. How has the pace of BD been impacted by the recent decision to acquire Otezla?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 repos 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?3North America Equity Research03 September 2019Cory Kasimov(1-212) 622-5266cory.w.kasimov@jpmorgan.com Biogen (BIIB; N)Bigger Picture#1. How would you categorize the current risk in the pipeline, and what are some ways to mitigate that risk?Given recent drug pricing pressures, how is Biogen positioned should some of the recent pricing proposals be implemented?Multiple Sclerosis (MS)#2. What are some opportunities to maximize potential of the MS franchise? How does the Tecfidera IPR filed by Mylan differ from prior IPR challenges, and when should we expect a formal decision from PTAB?What should we expect the initial Vumerity label to look like, and how might that impact positioning, physician willingness to prescribe, and switches from Tecfidera?SpinrazaHow are market dynamics between Spinraza and Zolgensma shaping up? Are they being used together, or are pts foregoing / discontinuing Spinraza for Zolgensma?What are y...
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