U.S. Biotechnology
Q3 Earnings Preview
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 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.
Research Analysts
Martin Auster, M.D.
212 325 6573
martin.auster@credit-suisse.com
Mark Connolly
212 325 7576
mark.connolly@credit-suisse.com
Tiago Fauth
212 325 7569
tiago.fauth@credit-suisse.com