- Isis Pharma held its 2q2011 earnings conference call on August 4, 2011 - click here for press release.
- For complete detailed information on Isis' many pipeline programs and alliances, visit the ISIS research page.
- For upcoming ISIS events, check the full calendar here (a couple presentations schedule and I expect a few more for the fall)
- My complete notes from the webcast are after the jump:
- We remain on track for mipomersen (Kynamro) NDA filing later this year
- 2011 financial guidance includes $25m NDA acceptance milestone [see discussion below. there is a reasonably high chance that the NDA is filed too late in 2011 to be accepted and have ISIS receive this milestone before 2012 - therefore negatively affecting the ability of ISIS to meet their yearend 2011 cash balance guidance]
- About to begin dosing in p2 CRP trial [I just added the Clinicaltrials.gov link and info to the ISIS research page]
- 1h2011 expenses were flat vs 1h2010, and will increase modestly in 2h2011
- This year expect to begin next mipomersen studies for additional regulatory filing [including 12 month exposure trial for expanded US indication for severe heterozygous familial hypercholesterolemia]
- Later this year we will complete obligation to spend $125m on mipomersen. Then split expenses 50/50 until product is profitable. Genzyme (now Sanofi SNY) pays all sales/marketing expenses in preparation for US and EU launch until product is profitable.
- 3 R&D building leases expire end of 2011. Chose to lease newly-built facility instead of renovation. Early entry to building required accounting recording of value of building as liability (slightly different than just accounting for capital lease, but doesn't look too different)
- (longwinded review of mipomersen by CEO Stan Crooke, nothing new)
- We know what studies we need to do and are about to start them [They knew what studies were need back in January too...].
- Pipeline: large number of trials coming to completion in next 6-12 monhts
- Expect to initiate trials of 3 or more drugs in 2h2011 and add 3 or more duegs to pipeline.
Question and answer session:
1) Kynamro/mipomersen pricing in EU. Will filing for broader population compared to US NDA cause pricing differences between geographies? GENZ is responsible for pricing and they have not yet set pricing. We don't believe there will be a dramatic difference in pricing between EU vs US. Most analysts are using cost of apheresis as surrograte (much more common in EU vs US, around $100k per year)
Update on 12 month exposure study? We are very excited about it. Extension study continues to perform well (141 pts?). New 12 month study will get underway in next little bit.
What are Sanofi's plans for EU beyond first filing? broader heFH population? Yes, absolutely. Plan we've advertised all these years has not changed. When will additional trials start? Very shortly.
2) Acceptance of NDA 4q11 vs 1q12? Crooke wouldn't bite, Only will say filing will occur this year.
3) Update on prelaunch marketing activities? Genzyme has a great plan, have had a very important presence at major CV meetings. Focus on physican (lipidologists) that treat these patients. Also on educating referral physicans (internal medicine, cardiologists). The level of interest in cardiovascular community is amazing.
What are you most excited about beyond Kynamro/mipomersen? APOC-III, Factor XI, in addition to EXC011 and CRP. We believe we can show POC and proof of value in early studies. Will complete SGLT2 trial soon, that target is obviously in a complicated environment [odd remark stuck in, setting up to kill this drug?]. EIF4E getting underway, data from LLY survivin soon.
4) How are alternative dosing trials with mipomersen going? We looked at daily vs 3x weekly vs weekly. Very positve results. Looked and did not see increase in systemic markers of inflammation. Working on final presenation for daily doisng data before starting additional daily dosing trial. We are setting out to provde options to patients (not trying to fix any injection site reaction problem).
Update on publication of pivotal trials in peer reviewed journals? Severe hypercholesterolemia has been submitted, and heterozygous FH also. Both are in the review process in top tier journals. Higher risk trial paper is not as far along. Also continuing long term open label safety study and look forward to presenting that important data also.
5) Do you think there is any read thru from Provenge (Dendreon $DNDN prostate cancer vaccine that badly missed sales targets) launch trajectory problem to Kynamro/mipomersen? No. We don't think DNDN adoption was that slow, the problem was the expecations were too high. In contrast, we think expectations for mipomersen are far too low. We have not provided any projections. We have guided that initial patient population numbers 3000 in US, 18000 in EU and general pricing range. And there is an urgent need for this drug.
6) Genzyme bought 5m shares at $30. Have these been registered? Are they still retained for investment? GENZ still owns those shares.
1) Kynamro/mipomersen pricing in EU. Will filing for broader population compared to US NDA cause pricing differences between geographies? GENZ is responsible for pricing and they have not yet set pricing. We don't believe there will be a dramatic difference in pricing between EU vs US. Most analysts are using cost of apheresis as surrograte (much more common in EU vs US, around $100k per year)
Update on 12 month exposure study? We are very excited about it. Extension study continues to perform well (141 pts?). New 12 month study will get underway in next little bit.
What are Sanofi's plans for EU beyond first filing? broader heFH population? Yes, absolutely. Plan we've advertised all these years has not changed. When will additional trials start? Very shortly.
2) Acceptance of NDA 4q11 vs 1q12? Crooke wouldn't bite, Only will say filing will occur this year.
3) Update on prelaunch marketing activities? Genzyme has a great plan, have had a very important presence at major CV meetings. Focus on physican (lipidologists) that treat these patients. Also on educating referral physicans (internal medicine, cardiologists). The level of interest in cardiovascular community is amazing.
What are you most excited about beyond Kynamro/mipomersen? APOC-III, Factor XI, in addition to EXC011 and CRP. We believe we can show POC and proof of value in early studies. Will complete SGLT2 trial soon, that target is obviously in a complicated environment [odd remark stuck in, setting up to kill this drug?]. EIF4E getting underway, data from LLY survivin soon.
4) How are alternative dosing trials with mipomersen going? We looked at daily vs 3x weekly vs weekly. Very positve results. Looked and did not see increase in systemic markers of inflammation. Working on final presenation for daily doisng data before starting additional daily dosing trial. We are setting out to provde options to patients (not trying to fix any injection site reaction problem).
Update on publication of pivotal trials in peer reviewed journals? Severe hypercholesterolemia has been submitted, and heterozygous FH also. Both are in the review process in top tier journals. Higher risk trial paper is not as far along. Also continuing long term open label safety study and look forward to presenting that important data also.
5) Do you think there is any read thru from Provenge (Dendreon $DNDN prostate cancer vaccine that badly missed sales targets) launch trajectory problem to Kynamro/mipomersen? No. We don't think DNDN adoption was that slow, the problem was the expecations were too high. In contrast, we think expectations for mipomersen are far too low. We have not provided any projections. We have guided that initial patient population numbers 3000 in US, 18000 in EU and general pricing range. And there is an urgent need for this drug.
6) Genzyme bought 5m shares at $30. Have these been registered? Are they still retained for investment? GENZ still owns those shares.
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