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报告标题和描述提到了"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"，这是瑞士信贷(Credit Suisse)发布的一份关于美国制药行业的研究报告，重点关注了公司管理层面临的挑战和可能影响公司业绩的问题。报告涵盖了大型制药企业（如ABBV, AGN, BMY, JNJ, LLY, MRK, PFE 和 TEVA）以及中小型制药公司（如ACRX, AIMT, ALDR, ALKS, ALNA, FOMX, GLPG, IRWD 和 PTLA）。以下是报告中可能涉及的一些关键知识点： 1. **药品价格和自付支出政策**：美国总统的药品价格降低蓝图是一个重要的讨论点。管理层可能需要解释这些政策提案如何影响其业务，特别是对于AbbVie这样的公司，因为这些政策可能直接影响药品的定价和消费者的负担。 2. **去除回扣的影响**：报告提出了如果从Part D计划中移除药品回扣将如何影响AbbVie的问题。同样，如果在商业保险计划中也执行类似政策，考虑到Humira（AbbVie的主要产品）约85%的销售额来自商业计划，这可能会有重大影响。 3. **Humira专利的法律挑战**：Humira的专利问题在参议院听证会后引起了关注。管理层可能需要讨论是否面临更多关于专利有效性的质疑，以及这如何影响其市场地位和收入。 4. **Humira的净定价假设**：报告询问了管理层对未来1-2年及直至2022年（生物类似药可能进入市场之前）Humira在美国的净定价预期。这是一个关键的财务预测，关系到公司的盈利能力。 5. **共付累积器的影响**：共付累积器是一种保险策略，可以增加患者对高价药物的自付费用。报告询问了这些变化对Humira销售的影响，这可能揭示了公司在应对医保政策变化时的策略。 6. **投资者会议**：报告背景中提到的即将召开的投资者会议，意味着制药公司的管理层需要准备好回答这些问题，以透明化公司策略，维护投资者信心。 7. **分析师角色**：瑞士信贷的分析师团队（如Vamil Divan, Uy Ear, Inanc Caner, Michael V. Morabito Ph.D.等）在此过程中发挥了重要作用，他们提供研究分析并可能与涉及的公司进行交流，以获取最新的市场和公司动态。这份报告关注了美国制药行业面临的政策压力、市场竞争以及专利挑战等问题，同时也强调了投资者在做投资决策时需要考虑的潜在冲突利益。通过深入理解这些知识点，投资者和管理层都能更好地评估制药公司的前景和应对策略。

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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

vamil.divan@credit-suisse.com

Uy Ear

212 325 1729

uy.ear@credit-suisse.com

Inanc Caner

212 325 5051

inanc.caner@credit-suisse.com

Michael V. Morabito Ph.D.

212 325 7298

michael.morabito@credit-suisse.com

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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