Analyst Conference Summary |
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biotechnology
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Gilead Sciences
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Gilead Revenues by product ($ millions): | ||||
Q3 2018 |
Q2 2018 |
Q3 2017 | y/y increase | |
Atripla | 258 |
349 |
439 |
-41% |
Truvada | 757 |
765 |
811 |
-7% |
Viread | 70 |
82 |
274 |
-74% |
Stribild | 146 |
187 |
229 |
-36% |
Genvoya | 1,176 |
1,160 |
988 |
19% |
Biktarvy | 386 |
185 |
0 |
na |
Complera | 139 |
199 |
237 |
-41% |
Descovy | 406 |
403 |
316 |
28% |
Odefsey | 423 |
385 |
296 |
43% |
AmBisome | 102 |
103 |
92 |
11% |
Ranexa | 178 |
208 |
164 |
9% |
Letairis | 241 |
244 |
213 |
13% |
Vosevi |
103 |
109 |
123 |
-16% |
Harvoni | 311 |
331 |
973 |
-66% |
Epclusa | 477 |
500 |
882 |
-46% |
Zydelig | 20 |
39 |
40 |
-50% |
Yescarta | 75 |
68 |
0 |
na |
Vemlidy | 87 |
76 |
37 |
135% |
Other | 64 |
115 |
273 |
-77% |
Royalty, contract and other revenue was $141 million, up sequentially from $108 million, and up from $110 million year-earlier.
Cash and equivalents ended at $30.8 billion, down sequentially from $31.7 billion. $2.2 billion cash flow from operations. $449 million was used for repurchase shares. $742 million paid in dividends. Long term liabilities were $31.2 billion. $1.8 billion was used to repay notes due in September 2018.
Selonsertib for NASH is in 2 slightly different Phase 3 studies, with data available in first half of 2019. GS-9674, and GS-0976 for NASH are in Phase 2 studies in combination with selonsertib. GS-0976 has reported positive Phase 2 results as a monotherapy. Gilead is developing non-invasive tests to find patients needing treatment, to replace liver biopsies. But discontinued selonsertib for severe alcholic hepatitis.
Filgotinib is now in Phase 3 trials for rheumatoid arthritis, Crohn's, and ulcerative colitis, all of which are fully enrolled. Reported positive data in rheumatoid arthritis. More Phase 3 data expected in first quarter of 2019. An NDA filing, however, is dependent on the separate Manta trial. Six additional Phase 2 study across a range of diseases are planned with partner Galapagos, with more data available later this year. Phase 2 study of psoriatic arthritis achieved is primary endpoint.
More Yescarta data is expected in 2020. KITE 319 results were presented at ASH. 17 of 24 patients had complete remissions. Received regulatory approval of Yescarta in Europe, so building a new facility in Netherlands. An ongoing Phase 3 study, if successful, could expand the label to earlier lines of therapy.
Licensed the Trianni transgenic human monoclonal antibody discovery platform. Also announced a collaboration with Gadeta for gamma delta T cell receptor therapies for cancer.
Discontinued Andecaliximab for gastric cancer, which had been in Phase 3.
Liver disease data including for NASH will be presented at a medical meeting next month.
Numerous other studies are underway or planned; see Gilead pipeline.
Cost of goods sold was $1.09 billion. Research and development expense was $0.94 billion. Selling, general and administrative expense was $0.95 billion. Income from operations was $2.62 billion. Interest expense $264 million. Other income was $305 million. Income tax provision was $565 million.
Q&A:
Bictavy switches? Most prescriptions coming from switches, including from other Gilead therapies.
Descovy v. Truvada for prep? People prefer Descovy as the better drug.
Filgotinib v. competitors? Efficacy is as good or better than any other drug in the class, including biologics, including non-responders. In safety we are good, need to see if it holds up in Phase 3.
Hep C market stabilization? Pricing has become stable this year, but number of patients has continued to decline. We think the authorized generic will boost us, including with access to Medicaid population. So we see the market as stable into 2019 and beyond.
Leadership change? We have a lot of interested CEO candidates, we hope to have an announcement before the end of the year.
We don't have a timeline for completing the Manta trial. We continue to talk to regulators.
Atlas Phase 2b NASH study will provide a look at week 24. If there is clear separation without biopsy we could move on to Phase 3.
Hep B combinations? We are never satisfied, we are looking internally and externally as well. We are watching the srRNA field carefully.
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Copyright 2018 William P. Meyers