美股-生物制药行业-2019年三季度美国生物制药业业绩预览

U.S. Biotechnology Q3 Earnings Preview Biotechnology | Comment We generally expect earnings to be in line with consensus across our coverage universe, but we could see some volatility for our commercial names, including:  Insmed (INSM). This is likely to be the name in our coverage universe that is most likely to have 5-10%+ price volatility on the quarter, as shares have had fairly large swings on prior commercial updates, and this name by far has yielded the greatest inbound interest so far with respect to Q3 results. We estimate Q3 Arikayce sales at $37m vs. consensus $35. However, we believe actual revenue numbers vs. consensus will be overshadowed by any disclosure on number of new starts and metrics on durability of treatment. We would be constructive with stable patient adds (>550-600 new starts in Q3) and further evidence of solid duration of treatment (possible commentary to look for could touch on topics like percentage of Arikayce-treated patients continuing on treatment beyond month 6, the degree of payer restrictions related to reauthorization beyond month 6 for non-culture converters, and the percentage of patients that culture convert—we think commercial practice conversion rates may exceed the ~30% rate observed in the Ph3 trial). We had management on the road last month and felt they seemed confident re Q3 results.  United Therapeutics (UTHR). Three manufacturers have received approval for generic Remodulin, and we expect investor focus to remain focused on trajectory of loss of share for UTHR’s parenteral treprostinil franchise. We think upside to Street numbers in Q3 is possible, as the ongoing litigation with Sandoz/RareGen (which we see impacting other generic players as well) may provide upside to SC Remodulin brand persistence. Meanwhile, we have found no signs of clear payer pressure on brand Remodulin in the early days of the 2nd and 3rd generic treprostinil launch.  Non-Commercial Companies. Earnings is generally uneventful for our non-commercial companies, and the companies commonly use the call as an opportunity to refresh investors on the story and to provide an update on pipeline developments. While not guided for, we believe the following could have a more eventful earnings if they disclose new clinical results from their pipeline programs. o MYOK Mavacamten Non-Obstructive HCM Ph2 Data. See our noHCM Ph2 Preview. o SLDB SGT-001 (DMD Gene Therapy) High Dose Ph1/2 Data. See our SGT-001 Ph1/2 Preview. o OBSV Nolasiban (IVF) Ph3 Results. See our Nolasiban Ph3 Preview. o ALNA Reloxaliase Ph3 uriROX-1 Results. See our uriROX-1 Preview.  Model Changes. As part of this note, we are introducing new model/valuation methodology for IRWD. As part of this, we lower our target price from $14 to $11. Separately, we lower our ICPT TP from $167 to $87. 18 October 2019 Equity Research Americas | United States DISCLOSURE APPENDIX AT THE BACK OF THIS REPORT CONTAINS IMPORTANT DISCLOSURES, ANALYST CERTIFICATIONS, LEGAL EN