I had a half position on the potential of being CV positive. Today's 50% interim data release put an end to that thought. Sold it at $6.33 as soon as I was aware of the news. My MO is to sell immediately when the investment thesis is broken and don't look back. Did the same with NKTR when the 181 Phase 2 failed. I'm pretty sure OREX is going lower from here.
HR didn't say that an FDA meeting wouldn't be held until the end of the year. What he said is that a decision about how to proceed would occur by then. I suspect that discussion with the FDA has already started. The onus is on NKTR to provide data that conclusively demonstrates the efficacy and safety of NKTR-102, to whatever level the FDA demands. Since the overall Phase 3 study failed, the discussions need to identify an NDA for what application (all MBC, liver mets, brain mets), what data is required for the selected application, and whether NKTR has all of the data from the Phase 3 to support submission or more is required.
Here's a quote from his analysis... "we assume a WACC of 10%, consistent with our standard WACC for development-stage companies, a terminal value post 2028 and no terminal growth rate." I think it's a Merrill standard in their analyses.
I forgot to include the probabilities, an important part of the analysis.
None - $0, 15%
CCALD - $9, 22%
BT - $186, 12%
SCD - $198, 7%
CCALD+BT - $195, 18%
CCALD+SCD - $207, 11%
BT+SCD - $385, 6%
CCALD+BT+SCD - $393, 9%
Ying Huang of BAC has a $154 price target on BLUE based on probability of products coming to market and a 10% weighted average cost of capital (WACC). Broken down by target as follows.
CCALD - $5, 60%
BT - $76, 45%
SCD - $60, 33%
But of course, coming to market is a discrete action. So the valuations of each of the targets is as follows if they do reach market.
CCALD - $8
BT - $169
SCD - $180
So we can look at the combinations for discrete price targets for BLUE. This assumes zero value for anything else the company does. 10% WACC is added to each.
None - $0
CCALD - $9
BT - $186
SCD - $198
CCALD+BT - $195
CCALD+SCD - $207
BT+SCD - $385
CCALD+BT+SCD - $393
He also believes that if BLUE continues to bat 1.000 on BT through ASH, that accelerated approval from the FDA is a possibility. Wonder where he got that notion? That would be a game changer, since BLUE would start get paid for treated BT patients.
It looks like the company already has the ability to treat 1-2 patients per week. It appears to be scaling up without major problems. The report couldn't be better. I can't wait to see the data. I'm anxious to hear about FDA discussions too.
Last week they did a secondary of over half their market cap. This morning they announce a clinical hold on their lead candidate due to nasty side effects. Blecch!
M&A strategy is paying off. VBS sales soon to exceed EGHT.
Change in most recent quarter sales YoY.
VBS - $42M, +120% (49% organic)
RNG - $65M, +35%
EGHT - Coming May 20
Only a 20% increase in sales expected rather than the 40% consensus next quarter. That seekingalpha guy must be shocked. Imagine what an old fashioned cyclical slowdown might do.
Rolling NDA means that SNSS doesn't have all the data in hand to submit a complete NDA. I interpret this as meaning that further studies may be required. Starting the NDA submission doesn't mean much. What's more important is when the last data is submitted.
Check the user ID of the post. It's Kennedy's phony Klaus ID, note the two n's in the user name. Yahoo (jerks) is supposed to ban spoofing ID's, but they never do anything.
You are exactly right. The end of the year is when NKTR will decide how to proceed with NKTR-102. The decisions could be submit NDA's in the US and EU, drop the drug entirely, or anything in between.
TSLA announced 10kWh total battery backup for $3500 (plus installation I assume). It might work for a solar house in which the battery could be recharged during the day even if the power is out. It's way too small to power air conditioning for very long during an outage. I don't think it makes much sense at all without solar on your house.
Anything that increases lithium usage is good in my book.
Maintains underperform, $9 PT. He now models 40% chance of NKTR-102 approval based on BEACON, but says "we could still be aggressive". He models 2015 Movantik sales of $40M US and $8M EU. He makes an interesting point that if Movantik sales take off better than expected, then expect competitive drugs like oral Relistor and bevenopran to be advanced quickly. He believes that DTC advertising is key to increasing Movantik sales. NKTR apparently agrees, as the company stated in the CC they are providing money to support an advertising campaign.
I think you're being hard on HR for the wrong reasons. Absolutely nothing about the NKTR-102 path forward has changed since BEACON results were presented. The end of 2015 has always been a reasonable date for NKTR-102 review completion with the FDA and EMA. The NSCLC study was investigator (not NKTR) initiated and it's not really relevant to BEACON. It's up to the investigator to present results as he sees fit. I believe the odds are against accelerated approval for NKTR-102, meaning another Phase 3 would be required. If approved, it would likely be only for brain mets. But I wouldn't be surprised if NKTR-102 were given breakthrough designation (without AA) for that. HR is wise not to start another NKTR-102 study until this is clarified given the company's cash position.
Did you catch the very first analyst question about AZN getting Movantik onto insurance formularies? Not many patients will take Movantik daily at $250/month out of pocket for intermittent constipation. Especially when you can buy a box of 24 bisacodyl at Dollar Tree to try first. Especially when Movantik appears to be effective when taken as needed rather than daily. Getting it on the formulary means patients pay $20-$40 copay per month rather than $250. The difference in price represents a car payment to the average Joe.