Data from APOCIII Rx program in November at the American Heart Association Meeting
FXI Phase II results and partnering
STAT3 Phase II results
1-3 Biogen-like deals
ISIS option deal structure - SMN, TTR, STAT3 - options exercise after phase II prove of concept studies triggers big milestone payments
Sentiment: Strong Buy
Regarding press releases they should do much better. It´s not definite expressed that the potential 220 Mio milestones are for every selected target.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) reported Q2 EPS of ($0.09), $0.12 better than the analyst estimate of ($0.21). Revenue for the quarter came in at $38.1 million versus the consensus estimate of $26.76 million.
I have a very big position in Isis and have to be careful. Overall I´m maybe too enthusiastic about ISIS potential so I try to evaluate some risks. The FGFR4Rx Phase I Study is completed at least since Dec´12 (Metabolic pipeline presentation) and no results thus far. Potentially CRP is a really huge drug but why ISIS try to hide this drug, no mentioning in recent presentations or very very conservative remarks. (Sorry for my poor spelling.)
At annual meeting they will get new options. The lower the stock price the lower the options pricing. I think we will see poor results on ISIS-CRP and ISIS-FGFR4Rx soon. All management signs point to such results but CRP was always a wild card. The rest of the year we ´ll see a lot of big news with much better results. ISIS-APOCIII, SMA, Factor XI, STAT3 are only a few of them.
ISIS is one of the best biotechs without daubt but short-term I expect (and ISIS Management seems too) some disappointing ISIS-CRP data. The obesity drug program ISIS-FGFR4Rx will probable be terminated soon. I hope the annual Meeting next tuesday will change the trend.
In the event we or one of our strategic alliance partners continues with the development of a program, each of Alnylam and Isis are entitled to
royalties as a percentage of net sales. For products that we independently commercialize, these royalties will be in the low single digits. For
products commercialized by a third-party collaborator, the royalties will be either the same percentage of net sales as described above or, if the
sublicense does not provide a specified level of royalties to us or upon our election, a percentage of the sublicense income received by us from
the strategic alliance partner and a modified royalty. The modified royalty would be based upon the lower of the single digit percentage
discussed above or one third of the royalty received by us after payments made by us to third parties for development, manufacture and
commercialization activities under other agreements. In addition, if we sublicense rights to a collaborator, we will be required to pay to each of
Alnylam and Isis a percentage of our sublicense income in the mid-single digits. We are also responsible for payments due to third parties under
other agreements as a result of our development activities, including payments owed by Alnylam and/or Isis under their agreements.
Under the October 2011 amendment, Alnylam and Isis granted us the right to research micro RNA mimics under the licensed intellectual
property of Alnylam and Isis. In the event we develop a miR-mimic, we must first obtain approval from Alnylam and/or Isis, as applicable, and
such approval is subject to the consent of applicable third parties, if any. No additional consideration will be owed by us to Alnylam or Isis for
granting approval. We have the right to sublicense our research rights. We granted to both Alnylam and Isis a fully paid up, worldwide and exclusive license to any intellectual property developed by us and useful to their research programs and which are
not micro RNA antagonists or approved miR-mimics.
The agreement expires on the earlier of the cessation of development of the potential royalty-bearing products prior to the commercial sale of
any such products anywhere in the world or following the first commercial sale of such products, the expiration of royalty obligations
determined on a country-by-country and product-by-product basis.
And so our hit rate, or our failure rate of drugs that we identify – the targets that we identify and drugs we make is exceedingly well, and I think that’s impressive and that’s why we have 28 drugs in clinical development, really almost as largest some pharmaceutical companies have.
UPDATE: BMO Capital Markets Raises PT on Isis Pharmaceuticals Following Development Head Meeting
11:00a ET April 19, 2013 (Benzinga)
In a report published Friday, BMO Capital Markets analyst Jim Birchenough reiterated an Outperform rating on Isis Pharmaceuticals (NASDAQ: ISIS), and raised the price target from $22.00 to $31.00.
In the report, Birchenough noted, “The BMO Capital Markets US biotechnology team hosted a meeting this week with Isis Pharmaceuticals SVP of Clinical Development Dr. Richard Geary. Focus of the meeting was on a burgeoning pipeline of antisense oligonucleotide (ASO) therapeutics following recent approval of its first ASO therapeutic KYNAMRO. With 28 different ASO therapeutics in development, primary focus was on key late stage programs including wholly owned ISISApoC3-Rx for severe triglyceride elevation as well as partnered programs for ISIS-SMN-Rx for spinal muscular atrophy (SMA) and TTR associated familial amyloid polyneuropathy (FAP).”
Isis Pharmaceuticals closed on Thursday at $19.41.
I hope they won´t sell! The point is which effect the change in accounting will have.
Balance Sheets: Investment in Regulus: 5,563 M
Isis owns 7 M shares. Will they account a gain of now 38-39 M $ in Q4 ?
What´s the fair value?
"The Phase 1 study of ISIS-CRPRx was a blinded, randomized, placebo-controlled, dose-escalation study designed to #$%$ the safety and pharmacokinetic profile of ISIS-CRPRx as well as to #$%$ the initial effects of the drug on baseline CRP levels. ISIS-CRPRx was evaluated in single and multiple doses ranging from 50 mg per week to 600 mg per week in 80 healthy volunteers. In all but one cohort, Isis enrolled subjects who had normal (generally undetectable to less than 2 mg/L) CRP levels. In the 600 mg per week multi-dose cohort, Isis enrolled eight subjects with elevated levels of CRP. The subjects enrolled in this cohort had an average CRP level at baseline of approximately 3.0 mg/L. After only three weeks of dosing, the six subjects who received ISIS-CRPRx had an average CRP level of 0.76 mg/L, which is within the normal range of CRP and represents an average reduction of greater than 70 percent compared to placebo. Subjects receiving placebo remained elevated above 3.0 mg/L. In all subjects receiving the drug, it was well tolerated with no serious adverse events. "
" After only three weeks of dosing, the six subjects who received ISIS-CRPRx had an average CRP level of 0.76 mg/L, which is within the normal range of CRP and represents an average reduction of greater than 70 percent compared to placebo"
I expect they´ll confirm the reduction of CRP levels. The wild card is which impact the reduction of CRP levels will have or not