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瑞信-美股-生物科技与制药行业-美国制药业:美国制药公司管理层的问题-5-21页.pdf
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瑞信-美股-生物科技与制药行业-美国制药业:美国制药公司管理层的问题-5-21页.pdf
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DISCLOSURE APPENDIX AT THE BACK OF THIS REPORT CONTAINS IMPORTANT DISCLOSURES, ANALYST
CERTIFICATIONS, LEGAL ENTITY DISCLOSURE AND THE STATUS OF NON-US ANALYSTS. US Disclosure: Credit
Suisse 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.
12 May 2019
Americas/United States
Equity Research
Pharmaceuticals & Biotechnology
US Pharmaceuticals
COMMENT
Research Analysts
Vamil Divan, MD
212 538 5394
Uy Ear
212 325 1729
Inanc Caner
212 325 5051
Michael V. Morabito Ph.D.
212 325 7298
Questions for US Pharma Management
Ahead of some upcoming investor conferences, we present a list of potential
questions for management for the companies under our coverage. We list our
large cap coverage universe first, including ABBV, AGN, BMY, JNJ, LLY,
MRK, PFE and TEVA, followed by our SMID cap companies: ACRX, AIMT,
ALDR, ALKS, ALNA, FOMX, GLPG, IRWD and PTLA.
Please let us know if you would like our Excel-based models for any of
these companies.
12 May 2019
US Pharmaceuticals 2
AbbVie Inc. (ABBV)
■ How do you interpret the President’s Blueprint around lowering drug prices and out of
pocket spend? How might these proposals impact AbbVie and what proposals do you
think are most likely to be implemented?
■ How would the removal of rebates from Part D impact AbbVie? What if the same
happens in commercial plans, given ~85% of Humira sales come from Commercial
plans?
■ Have you received any further pushback on Humira’s patents following the Senate
hearing?
■ What are your assumptions around Humira net pricing in the US over the next 1-2
years and through to 2022 (prior to likely biosimilar entry)?
■ What impact have you seen from the copay accumulator programs that payers have
started to implement for specialty care products?
■ Now that a few months have passed since biosimilar entry in Europe, what are you
seeing in terms of pricing discount? How does this inform your expectations for
potential pricing erosion for Humira in Europe in 2020? What pace of adoption are you
seeing for biosimilar Humira? What do you assume for the impact of direct biosimilar
Humira competition in the EU in your mid-to-long term outlook?
■ You have mentioned the strong initial formulary coverage you have obtained for
Skyrizi. Are patients able to get on Skyrizi as initial therapy or is it after methotrexate or
after other biosimilars? What has been the early feedback from doctors and patients on
the drug since the launch?
■ What is the latest on regulatory discussions around upadacitinib? Do you expect an
FDA Advisory Committee Meeting to discuss that product?
■ What are your base case assumptions around the label for upadacitinib? Do you
expect both the 15mg and 30mg dose to get approved and should we assume a Black
Box Warning similar to the other JAKs?
■ In your most recent long term strategic outlook presentation, some of the numbers that
stood out to investors were nominal U.S. sales of $11.5Bn for Imbruvica and nominal
worldwide sales of $6Bn for Venclexta by 2025. Can you walk us through some of your
assumptions for those two products getting to be that large?
■ What are your latest expectations around the cystic fibrosis franchise after restructuring
your deal with Galapagos? How do you hope to compete with Vertex in this space?
■ ABBV talks about improving R&D productivity and creating a pipeline capable of
growing through the impact of biosimilars. How do you measure the company’s R&D
productivity? Can you give us a couple specific metrics that you look at as you
compare ABBV to your peers?
■ You have guided that you expect to obtain operating margins of 50% by 2020. Can you
further discuss where that expansion is coming from and what you expect beyond
2020, especially since some of your biggest drivers outside of Humira are partnered
products (e.g. Imbruvica, Venclexta)?
■ Are you restricted in terms of size of potential BD deals or is everything on the table?
With the Rova-T disappointment and ensuing impairment charge, how are you thinking
about business development in solid tumor oncology in particular?
12 May 2019
US Pharmaceuticals 3
Allergan plc (AGN)
■ What are the next steps after the Annual Meeting to find ways to turn around the story
and stock and generate value for shareholders after a long period of
underperformance?
■ How do you interpret the President’s Blueprint around lowering drug prices and out of
pocket spend? How might these proposals impact Allergan and what proposals do you
think are most likely to be implemented?
■ How do you see the longer-term outlook for Allergan’s topline growth given all of the
changes we have seen in the business over the past couple years?
■ How much pricing growth do you assume for Botox and Juvederm when you think
about their growth outlook through 2020?
■ There are several Botox competitors in the works that seem to have a differentiated
profile than what Dysport and Xeomin offered when they entered the market. What is
your strategy in maintaining share in the face of additional branded competition,
especially after the approval of Evolus’ Jeuveau?
■ Mylan and Revance announced that they are working towards a biosimilar Botox.
While the commercial impact may be far away, how do you think about the risk to the
aesthetics and therapeutics franchise should a biosimilar Botox make it to the market?
■ At your 2018 Medical Aesthetics Day there was a considerable amount of time spent
on your ex-US opportunity. Why was this not pursued more aggressively before and
when do you think the added ex-US sales will be meaningful enough to drive the
needle for a company of Allergan's size?
■ At your Medical Aesthetics Day you also highlighted Coolsculpting as an important
growth driver. Can you explain the challenges you have had with that product since
then and when do you expect sales growth to reaccelerate? What will drive the growth
other than the CoolTone launch?
■ What gives you confidence that the liver safety profile of ubrogepant (acute migraine) is
acceptable enough to allow for regulatory approval? How do you expect the product to
compete against generic triptans as well as BHVN's rimegepant and LLY’s lasmiditan?
■ Given that CGRP antibodies allow for very infrequent dosing (monthly or quarterly) for
migraine prevention, what percent of the market do you think would be willing to take a
medication every day, even if it is an oral product as opposed to an injectable?
■ Can you expand on what you see as the commercial outlook for cenicriviroc (CVC)
following the data to date for that product? How does the NASH market get developed
and how is AGN helping to build that market?
■ Given the FDA did not approve Esmya, what are the next steps for that product?
Would it make sense to stop development of the product completely at this point given
the continued investment needed and likely limited commercial potential?
■ How does the negative rapastinel data impact your views on the oral AGN-241751?
■ What are reasonable expectations for abicipar now as we await data for the next-
generation formulation? What information from the new formulation would make it into
the product label? How much inflammation is acceptable in the real world? Are you
planning on holding back on launching the product until the next generation formulation
is available to avoid physicians having a negative initial experience with the product?
■ Have you seen any impact in the US on the European decision around breast
implants? Have the EU concerns impacted commercial use in the US so far?
12 May 2019
US Pharmaceuticals 4
Bristol-Myers Squibb (BMY)
■ Historically, large M&A deals in biopharma have had a mixed track record. What gives
you confidence you can successfully integrate Celgene without disruptions on the
commercial or development side?
■ How do you respond to investors that believe the Celgene deal signals a lack of
confidence in your current base business?
■ Will R&D expense continue to rise significantly despite the anticipated synergies from
the Celgene deal? How do you prioritize R&D spend over the next 2-3 years given the
numerous opportunities you have? How should we think about your operating margin
progression following the close of the Celgene acquisition?
■ How do you anticipate allocating capital both prior to the deal close, and then in the
ensuing 12-18 months while you are focused on deleveraging?
■ Out of the "Big Five" Celgene pipeline assets you highlighted, is there one in particular
you are most excited about? What are your peak sale assumptions for each one?
■ Ozanimod is one of the "Big 5" that investors may be most cautious on given the prior
Refusal to File letter the product received. What made you comfortable with the
potential of this product? If this product does fail, how does it change the valuation of
the deal?
■ What are your latest expectations for timing of data for CheckMate-227 Part 1a and
Part 2, as well as CheckMate-9LA?
■ How do you see Keytruda’s approvals in 1L NSCLC impacting the market potential for
Opdivo/Yervoy in 1L NSCLC? How difficult will it be for you to gain traction even after
CheckMate-227 and CheckMate-9LA given the head start Merck has in this market?
How much added efficacy does the Opdivo + Yervoy combo need to show over PD-1
monotherapy or PD-1 + chemotherapy to gain broad adoption?
■ What percentage of the 1L and 2L melanoma market do you have relative to Keytruda?
What are the key factors to think about as to how the market share breakdown in
melanoma will compare to what we might see in 1L NSCLC for Opdivo+Yervoy should
CheckMate-227 Part 1a read out positively?
■ In renal cell, how do you envision the Opdivo+Yervoy combo holding up in the face of
positive data from other PD-(L)1 based combinations, especially Keytruda+Inlyta?
■ What are the main I-O indications that you are excited about over the next 3-5 year
period, outside of lung, renal and melanoma where most people have been focused?
■ What are your current expectations on timing for data from your key adjuvant trials for
Opdivo +/- Yervoy? What do you think are reasonable assumptions for duration of
therapy in some of the larger adjuvant indications such as breast and lung cancer?
■ What other areas, besides I-O, do you think investors are underappreciating as you
think about Bristol’s outlook for the next 2-3 years?
■ How does the Celgene deal impact your ability to initiate new trials by this year’s
deadline in the Nektar agreement? What are your expectations for your collaboration
with Nektar? Why did you go through with collaboration vs. an outright acquisition?
■ How do you interpret the President’s Blueprint around lowering drug prices and out of
pocket spend? How might these proposals impact Bristol and what proposals do you
think are most likely to be implemented? How would the proposed rule removing
rebates in Part D impact you given Eliquis is a large Part D product and we believe
rebates have helped both Eliquis and Xarelto dominate the NOAC market?
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