I don't think he's the "Whiz." Doc was not much of a trader and this guy not only trades himself, but recommends it for everyone. Doc was also pretty upfront about his oncology background and I think he was still seeing patients while he was posting here. Just guessing and can't say for sure. Out of the office today, see you guys tomorrow.
"I expect at least one more large dip pre-ASCO, much below $4, I intend to load up the pack mule..."
There you go making predictions and naming numbers, shame on you. It actually sounds very plausible and if it occurs I will probably do the same thing.
" A trial in NSCLC either with Nivolumab or following Nivolumab..."
Problematic is that BMT already has a pivotal combination trial in frontline NSCLC underway. I don't think they will be very interested in a Nivo/Cabo doublet unless Checkmate 227 fails. Nivo is presently 2nd line SOC following platinum therapy, but if/when it moves to frontline pursuing a Cabo/Nivo combination gets more difficult.
"A Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 227)"
One time only deal just for you. I have a quick article for you to read and then look at their market cap.
"The Feuerstein-Ratain Rule Update: Still Perfect Predicting Small-Cap Cancer Drug Failure"
There was one other red flag that would stop me right away and that is the low institutional investment. I don't like seeing numbers less than 60% institutional interest. The design of the pivotal trial compares their drug to physician's choice from a menu of 5 other options. Half will be on the test drug, so there is plenty of statistical power for that arm to give a representative result, but from among the various controls, the sample size of each will be small increasing the chance of a misrepresentative result that outperforms the test drug. Not sure if the endpoint is outperforming the amalgamated result of the control arms or outperforming all of them individually at a significant level.
That's a superficial look and perhaps being intimately familiar with the ph 2 data would give me the confidence to ignore the aforementioned concerns, but it doesn't look all that promising to me.
Financial guidance for the year did not change. Even though the 1Q revenue numbers did not reflect it, uptake for RCC is solid. Encouragingly patient duration on therapy appears to be mimicking the trial result of 7 months. Cobi is a stinker for EXEL. The question finally got asked and answered that it would be a loser for the year. That's why I made the comment a few days ago that the Cobi co-promote will not be a money maker unless Roche expands into another indication. The stock already took a hit today before the CC. I did sell during the call. I don't see a dip below $4, but I don't see EXEL outperforming the sector for a while unless there is a news event of some kind.
The off label use they were primarily referring to was in RCC. Until the approval, ,RCC was an off label indication. The only other reimbursable off label use for Cabo in is RET driven NSCLC.
'"The "RESORCE" in second-line HCC has announced that it met its primary endpoint."
Regorafenib does have a black box warning for hepatotoxicity. It looks like the trial went to full completion ruling out a hit on an interim indicating exceptional efficacy. We'll just have to wait for results and see how it did.
Product revenue in the 4th 2015 was 9.9. Product revenue in the 1st Q was 9.1 plus 5 in contract revenue. Cabo sales actually decr slightly Q over Q.
"Cabo revenue up almost 50% from last quarter."
Cometriq sales in the 4th Q 2016 were $9.9M, So revenue has fattened out. The Cobi loss is in sales and admin expenses. I expect them to break it out in more detail in the call. Sorry, but pretty uninspiring with no "new" news so far.
"...but I wonder who is has been more accurate you the VP of the Cheer team or Keo?
Your M.O. is to show up after a price drop and tell everyone you were short. I've personally given you the opportunity to lay out a prospective strategy and you never bite. At least Semanresu went on record this morning with a prediction. All your profits seem to only come with the benefit of 20/20 hindsight.
"What will actually happen: Ernie/Wilder please give us your take.."
I think the Cabo off label revenue will be better than expected, but I think Cobi will be a disappointment. So it kind of depends on the magnitude of each and which the market choses to focus on. It could be interpreted positively, negatively or just be a wash. Lost in the shuffle here is the fact that the trading range has moved up by 70-80 cents in just a few weeks so the momentum is positive, but it's tough to predict what happens next.
We also have gone a long time without any updates on Celestial progress and commercial development beyond HCC has not been addressed yet. If they discuss these issues tomorrow afternoon we will at least have some stuff to talk about.
"Still waiting for those revenues projections for the Cobi products. Oh wait! Losing money as predicted."
It can be argued you were right for the wrong reasons, but you were right nonetheless. The only way the co-promote pays off is if Roche opens a 2nd indication for Cobi outside melanoma.
"An earlier than expected CHMP opinion would add some extra weeks of revenue to this year's earnings."
Negligible impact in 2016. EXEL's royalty rate on the first $50 M in sales is 2%. The sooner they get spooled up, obviously the better. It would help the CY 2017 sales tremendously if the drug is commercially available throughout Europe by year end. Royalties reset each CY and the rate jumps from 2% to 12% after the first $50 M.
"erniewerner did not. unfortunatley."
Let's correct that oversight. Last month I posted the following:
"I think 2017 will be closer to $350 total revenue. With Cobi underpriced and EXEL supporting half of the US marketing costs, I believe it will be marginal revenue producer. Cabo in MTC and off label is about $50 million and that leaves $300 million from RCC."
Now that we see label with better than anticipated mOS and no black box warning, I will revise my estimate to $375 total for 2017, $325 from RCC.
"Does this type of valuation pretty much blow the standard valuation for biotechs right out out of the water?"
Not really, but it does refocus attention on the group and shows what a disruptive technology can be worth.
"$12B for a startup without any revenues and existing debt?"
More like $6B and another $4 in contingencies if the pipeline is successful. No debt.
"Are SVB and Deerfield one and the same"
Silicon Valley Business Journal is a newspaper. Silicon Valley Bank is a bank. Deerfield is a venture capital fund specializing in biotech. Silicon Valley Business Journal reported on the acquisition. Silicon Valley Bank and Deerfield have no role in it.
"...doesn't EXEL also have a credit facility with Silicon Valley Bank which requires then to keep $80m in a deposit account?"
"Are SVB and Deerfield one and the same?"
Does this type of valuation pretty much blow the standard
From the Abbvie press release.
- Rovalpituzumab tesirine (Rova-T) is a biomarker-specific antibody drug conjugate targeting cancer stem cell protein DLL3
- Compelling data on Rova-T was presented at the European Society of Medical Oncology demonstrating overall response rates of 44 percent in DLL-expressing small cell lung cancer (SCLC) patients who have previously failed one or more standard therapies
- Rova-T represents a multi-billion dollar peak revenue opportunity with expected commercialization in 2018
- Long-term data on Rova-T, including overall survival, will be presented at the 2016 ASCO Annual Meeting; Rova-T was recently selected to be included in the Best of ASCO Program
- Expands AbbVie's oncology pipeline with four additional early-stage clinical compounds in solid tumor indications and a significant portfolio of pre-clinical assets
- Transaction valued at approximately $5.8 billion, with additional milestones payable upon successful completion of pre-determined clinical and regulatory achievements
"Will probably hold for a bit longer, just to expose my stupidity even more...I can't explain why I haven't cut the cord?"
Jerry, without giving specific advice, let me just emphasize a few of the things I posted yesterday. I do think the end game is a sale of the company for a premium. I do think Celestial will read out positively. I think the market undervalues the revenue stream Cabo will generate. I empathize with the obvious frustration felt by the majority of the shareholders. While I don't believe many of the theories behind the underperformance of the company as an investment, I certainly am not a fan of the current management. There could be some more pain in the near to middle term for investors, but my opinion is that long term holders from this point will eventually do pretty good.