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1、Global BioPharma 2020 HIF Survey Takeaways See the end pages of this presentation for analyst certification and important disclosures including non US analyst disclosures J P Morgan does and seeks to do business with companies covered in its research reports As a result investors should be aware tha
2、t 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 Global Equity Research February 2020 Conference Call Details Thursday February 20 11 00am ET 16 00 UK Contact
3、us or your J P Morgan sales representative for details Eric Joseph AC 212 622 0659 eric w joseph Turner Kufe MD 212 622 4104 turner kufe US SMid Biotechnology EU Pharma 6 were clinical trial investigators for HIF therapies 24 of respondents were affiliated with DaVita 33 were associated with Freseni
4、us Medical Care On average Physicians surveyed treated 116 patients with Anaemia secondary to End Stage Renal Disease ESRD and receiving dialysis moderate satisfaction among docs with current Tx options Source J P Morgan Research Breakdown of current treatment adoption Please rate your satisfaction
5、with currently available treatments of patients with ESRD related anemia 1 6 scale 1 very unsatisfied A majority 77 of physicians described themselves as moderately satisfied with existing treatment options Select quotes on satisfaction with current treatment options Uncertain risk profile of ESAs a
6、lthough other AE and discontinuations rate somewhat higher in Roxa group Seems to be equal to or superior to ESAs in preventing MACE but the side effect profile seems to be a little worse Worries me increased incidence of av fistula thrombosis with roxadustat Need more data I think longer term safet
7、y data will be needed Limited info available presented In the era that ESAs have gone through many years of use clinical studies Hands down ESAs are safer Less favorable 1 3 3 In line 4 30 More favorable 5 7 67 9 Please rank order each of the following potential advantages for roxadustat and the cla
8、ss of HIF inhibitors in the management of patients with ESRD related anemia Please rank where 1 most important advantage 2 2nd most important advantage etc Overall roughly half of physicians ranked Oral dosing ease of administration as the primary advantage of HIF treatment followed by the reduced r
9、equirement for IV iron Cost reimbursement benefits were regarded as the least important consideration HIFs Relative Advantage Oral administration seen as a primary differentiator Source J P Morgan Research Weighted Average of Advantages rank of HIF treatment 4 9 4 6 4 2 3 5 2 6 0 2 0 1 2 3 4 5 6 Ora
10、l dosing ease of administration Reduced need for IV iron Control over Hb rise ease of titration Adverse event safety profile Potential cost reimbursement benefits Other 53 3 20 0 16 7 6 7 3 3 0 0 ranked most important Most Important Least Important Note where Other was selected Physicians referred t
11、o the advantage of stronger efficacy in ESA hyporesponders 10 Incident prospectively designed to substantiate eGFR claims Roxadustat Impact on eGFR A majority view reduction ptl as very important Source J P Morgan Research Select quotes on eGFR reduction benefit preservation of eGFR is important Any
12、 impact on decline in EGFR is critical Preserving GFR in the non dialysis population is huge and a surprising result Curves parallel except for first 8 weeks Unconvincing benefit If this finding holds in larger sample sizes it would definitely encourage me to use the drug more Post Hoc Analysis wort
13、hless almost Companies do this when the results are not stellar Very Unimportant 1 2 13 Somewhat Important 3 4 13 Very Important 5 6 73 21 Roxadustat was also found to have statistically significant benefit on LDL levels In your view how IMPORTANT is this finding in determining whether or not to tre
14、at a patient with a HIF inhibitor in the non dialysis CKD setting The overall majority 80 of respondents view the potential for LDL reduction as an important finding but not as strongly as eGFR progression only 40 very important vs 70 eGFR 17 n 5 believe the finding is unimportant JPM View Given the
15、 moderate support for LDL reduction as meaningful clinical benefit in NDD CKD we believe the endpoint is unlikely to be a key adoption driver or differentiator within the HIF class Roxadustat Impact on LDL More mixed views on the importance of LDL reduction potential Source J P Morgan Research Selec
16、t physician quotes of LDL reduction potential If this is sustainable this is also a great effect as it may allow a lesser use of statins of course this would need to be studied or a potential life expectancy benefit less cardiovascular events useful characteristic but would not influence my decision to use Added benefit of improving LDL Again if this finding persists in larger sample sizes then it would be significant for our patient population Very Unimportant 1 2 17 Somewhat Important 3 4 43 V
