Onyx Pharma 4Q / Year End Conference Call
General impressions: Solid company that is executing pretty well right now. I expect that Kyprolis sales will increase nicely this year and they can easily push 200 million. Some important results expected this year for Kyprolis as they're trying to put together a package for European approval. Stivarga royalties are trickling in, and Nexavar continues to make money.
The two biggest issues I see for the company are its continued lack of profitability, and its total lack of an internal research & development arm. The former will presumably be corrected with time, but the latter is a different situation. They're focused on early stage licensing opportunities and they've had decent success to date. But given drug success rates in general, there is a chance that luck may run dry for the next little while. To be honest, I can't really decide if it's more cost effective to have an internal R&D department or try your luck with external opportunities. But given that they've let their internal efforts atrophy, it's safe to say that they don't have much of a choice. I think they'll be ok as long as they go for licensing deals with early stage compounds and/or buyouts of small, focused biotechs. I hope they avoid buyouts that intend to capitalize on revenue streams... Coles should have a picture of Colin Goddard in his office as a reminder of what not to do with your money.
2012 Performance by Drug
Kyprolis
- 64 M sales since July 2012
- 75% of their initial 2000 high volume targets have prescribed the drug at least once; >80% of these have ordered more than once
- >30% of third line MM patient share entering 2013
- they still expect new patient growth for Kyprolis in US
- modest footprint in Europe is based in Switzerland
- waiting for positive results from Aspire and/or Focus for EU submission
- in Japan, Ono pharma is developing Kyprolis
- no guidance for 2013
Stivarga
- 20% royalty from Bayer
- 8 M royalty since very late September 2012 (basically 4Q)
- no guidance for 2013
Nexavar
- global net sales of 861 million (excluding Japan); 3% increase over 2011
- US sales of 257 M for 2012 (8% increase from 2011)
- Rest of World sales of 605 M; double digit growth in Asia Pacific and Latin America (I think they mumbled something about a global demographic tailwind or something or other but I'm not sure)
- there was some pricing pressure in Europe
- for 2013 they project 890-920 M in global sales (excluding Japan); 62-64% commercial margin; assume dollar - euro exchange in mid 1.30s
Looking Ahead
Kyprolis / Proteasome Inhibition
- FOCUS trial planned interim analysis in 2H13; support approvals in relapsed / refractory MM; kyprolis monotherapy versus steroids and optional cyclophosphamide; primary endpoint is overall survival
- ASPIRE trial interim results in 4Q13 or later; support approvals in relapsed MM; PFS primary endpoint; revlimid / low dose dexamethasone +/- kyprolis
- ENDEAVOUR trial, head to head against Velcade, is underway (Started enrolling July 2012); relapsed setting
- planning second head to head front line setting versus Velcade
- Oprozomib, extended release oral proteasome inhibitor: data expected at international myeloma workshop in April
Stivarga
- US: GIST submission filed in August 2012 and has priority review
- EU: mCRC submission filed in May 2012 and action expected 1H!3; plan to submit for GIST after mCRC
- Japan: mCRC application submitted in July 2012 and has priority review; GIST submitted in December 2012
Nexavar
Decision trial in differentiated thyroid had met primary endpoint and they plan to submit sNDA this year (odd that there is no 1H or 2H timing... just said later this year; why so slow?)
Resilience trial in breast cancer; expect enrollment completion in 1H13
Palbociclib (PD-991)
- Pfizer CDK inhibitor
- Pfizer plans phase 3 in advanced breast cancer in 2013
- ER+ / HER2 - advanced breast cancer
- 1.5 million milestone in 2012
- 11.5 million more in milestone payments can be accrued
- 8% royalty on global net sales
tidbit: they expect to incur 60 M in expenses for the other drugs in the phase 3 kyprolis trials
- They had 493 M in cash and investments at YE2012 and raised 352 M in January 2013
Question and Answer
- pomalidomide impact: they don't expect much since they believe new agents just draws more people into treatment and that eventually (unfortunately) these people move through various lines of treatment
- some efforts to test kyprolis at once weekly dosing instead of twice
- they confirmed they don't have internal discovery and that they will simply look to find M&A and licensing opportunities
- oprozomib new formulation: it was meant to address GI toxicity; extended release tablet; they're dose escalating at this time; looking at proteasome inhibition... carfilzomib was 95% and oprozomib is around 88% so they expect / hope for similar efficacy
- 30% improvement for OS is the planning assumption for Focus at the final analysis
