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Q1 results time. So what are we reckoning? Disappointing royalty growth (yet again) suggesting that Shire isn't promoting HyQ anywhere in the world and that Roche is peaking on SC Mabthera and Herceptin in Europe despite all the spin. And the loss will be enormous due to completely out of control costs of PEGPH20 trials and for a way too expensive management structure. No new partnership deals, no news on early approval of PAG, no news on any of the other Enhanze partnership products and no news on when the next fund raising will be - although we all know it will be after SC Mabthera is approved by the FDA. All in all a typical HALO quarter.
Well it was clear why Baxter did the deal with HALO on Hylenex and it wasn't to sell it! Product suppression is the phrase that springs to mind. I have a horrible feeling that they have done the same to HALO on HyQ too. Roche haven't exactly been rushing to get SQ Mabthera and Herceptin approved in the US either have they? Sometimes corporate profits come before patients. These actions have resulted in the original plan of paying for in-house drug developments out of the royalty streams from partners look seriously flawed. HALO is burning money like confetti and there will have to be many more fundraisings before PEG ever comes to market in the 2020's - that's if it's ever approved of course.
A pretend doctor who posts a zillion times a day promoting HALO and CRBP on Twitter @Fezziwig2008. The more he posts the lower their prices go. I wouldn't fancy being Mrs Fezz!
A contested takeover approach from both Roche and JNJ may help a tad. Other than that it is going to be a long painful waiting game with no short term catalysts on the horizon this year (other than Mab) - just more huge losses.
Nothing probably as it's considered a shoe-in after the 11-0 Advisory Committee vote. If it's rejected though I would imagine there would be a total collapse as it would show that the FDA still doesn't trust HALO products.
Well even when the Phase 2 PEG/GEM/ABR trial didn't differentiate between high/low HA it was never halted for futility - it was halted twice for other reasons but never futility. So something is different on the PEG/FOL trial. Perhaps the Phase 2 headline results from the PEG/GEM/ABR trial were cherry picked and it basically doesn't work as previously touted by Adam Feuerstein. I'm amazed that he hasn't commented. But he's too busy slating Fezz's other top pick CRBP's trial results to worry about HALO. Fezz had a really bad week!
FOLFIRINOX TRIAL. If 40% of the patients had high HA you would have thought that PEG plus FOLFIRINOX would have had some effect instead of what appears to be no effect. Obviously we need to see the detailed data but the initial futility readout is not what everyone was hoping for or expecting. Certainly any lingering hopes of accelerated FDA approval of PEGPH20 in combination with ABRAXANE® and gemcitabine seem to have been dashed with this latest setback. Maybe PEG doesn't work in a statistically significant way.
Adam Feuerstein will have it in for HALO should it ever make serious progress. In his article today about Intrexon, but citing KIrk's apparently fortuitous sales of the useless New River, Clinical Data and Scios, he compares Intrexon to Theranos. HALO has suffered at his hands before and no doubt will again. He was just being kind when he accused HALO of cherry picking. Imagine what it would be like if he decided to attack with vigour,
FOTD - basically other than SQ Mabthera there are few short term catalysts that are likely to result in further approvals before 2020. So we have huge expenses for 3 years, which vastly exceed likely revenues - hence my $450m unfunded blackhole. I'm obviously nothing like as optimistic as you about the share price being pumped up by early stage trial results or new Enhanze partners/drugs, where we know it takes 5 years to develop and get approvals.
As I've been saying for a year they do have a $450m black hole to fill before any likely PEG approvals in 2020. I suppose we will just have to get used to further fund raisings every year until then. With royalties continuing to disappoint and no imminent news on the horizon other than US Mabthera approval, which everyone thinks is a gimme, it doesn't take a rocket scientist to know that the stock price will drift down in 2017 now that the funding problem is officially out in the open.
So no accelerated approval then. Not even a mention. Royalties pretty much static and out of control expenditure. Same old, same old. Guaranteed drop tomorrow. And it all looked so promising for a brief minute during the day.
Well it looked a possibility for a few crazy minutes but then the sellers who know the score came in - as usual. So no accelerated approval then!
Accelerated approval!!??
Results today. HALO never fails to disappoint.
Interesting news from Shire's Annual Report today. They say the conversion rate from Gammagard (or whatever they call it now) to HyQ is quite high. Strange as that's not really bourne out yet in HALO's royalty figures - probably because it's only been launched in minor markets. Also they will know the results of their Phase 3 SQ Cinryse trial (without Enhanze) in 2017. Be interesting to see whether it's an abject failure like we all hope and they have to come creeping back to HALO. Also Shire is being sued by the authorities for making endless pointless objections to stop others coming up with a generic of Cinryse (it's not patented). As I've been saying for years I couldn't understand why HALO didn't pursue this option once Viropharma kicked us into touch. I suppose we couldn't due to some contractual condition, which of course is something that could be a problem for HALO. For instance for all we know the Phase 1 SQ Humira trial could have been a big success but now that ABbvie have kicked us into touch we probably can't work on Humira for anyone else or even ourselves.
Lundbeck's sales of Northera in 2016 were $155m so no payout on the CVR in the second year either. In 2017 sales have to reach $300m.
Do we know whatever happened to Roche's then 5% stake in HALO, which it acquired at the time of the original deal in 2006?
"The Roche Venture Fund will make an $11 million equity investment, representing approximately 5% of Halozyme’s outstanding common stock."
Fezz is ranting on that it's only a matter of time before Roche bids for HALO. If this is true you would have thought that Roche would have been adding to their stake.
I didn't think that any shareholders had to opt for the CVRs - that was part of the deal if you accepted the offer from Cubist. I assume you probably sold your shares in the market prior to the offer closing for a small premium to the cash offer.
Anyway for the mighty Merck to sell just $14m of Sivextro in 2016 is pretty amazing. It just shows how much Cubist overpaid for Trius. So we were extremely lucky to get what we got! I have owned 4 biotech shares that sold out for cash plus CVRs. It looks like I'm going to get nothing from any of the CVRs. My view is that I'm a very lucky guy - the shares of all 4 were worth considerably less than the cash that I got.
As far as I can see it doesn't actually specify that RHUPH20 is included within what they call SC Perjeta. You are assuming it is by the exception mentioned in Cohort 8 right? Considering that this trial started 11 months ago and there has been no mention of a tie up on Perjeta until recently I am just wondering whether we are right in making this assumption.
Are you sure that the current Roche SQ version of Perjeta includes Enhanze? I thought that they were trialling their own SQ version currently. I know that HALO have said that they will commence working with Roche on a SQ version of Perjeta in 2017 but there's no guarantee of that if the non Enhanze version works fine.
Net sales for Sivextro in 2016 were $14 million. Please see the link below for an FAQ on the details.
http://s21.q4cdn.com/488056881/files/doc_downloads/other/Trius-CVR-FAQ-2.2.17-(1).pdf
Net sales for Sivextro in 2016 were $14 million. Please see the link below for an FAQ on the details.
http://s21.q4cdn.com/488056881/files/doc_downloads/other/Trius-CVR-FAQ-2.2.17-(1).pdf
Merck's 2016 results are out but no mention of Sivextro sales. I've written to Merck's investor relations and asked them to let Trius CVR holders know what the sales were. I've not had a reply. Is anyone optimistic that they've achieved over $125m. At the time of the takeover I though the $135m level would easily be achieved but Sivextro barely ever gets mentioned by Merck so now I'm not so sure.
Sivextro sales 2016. As a Trius CVR holder we need to know what Merck's worldwide Sivextro sales were in 2016 as we get a pay-out if they exceeded $125m. I can see no mention of Sivextro sales in the Accounts. Anyone know anything different? I've sent an email to investor relations at Merck but not received a reply yet.
We have had a number of big named Enhanze partners over the past 5 years but other than the initial up-fronts we have earned nothing from them. We have no new Enhanze drugs anywhere near approval and indeed had 3 Enhanze drugs dropped in 2016. The still much touted story of 150 potential drugs that could benefit from Enhanze is looking increasingly unlikely. And to rub salt in the wound Shire doesn't seem to be putting any serious marketing effort into HyQ where sales still seem to be minimal. I am also concerned about the US doctor and hospital reaction to SQ Mabthera and hopefully SQ Herceptin. Remember when SQ Herceptin was first discussed with doctors and hospitals in the US 5 years ago there was an outcry about lost revenues and profits from the switch from IV to SQ and threats to switch away from Roche products if it was introduced. Hardly a word about patients benefits! I'm sure this reaction has been the main reason for the delays in obtaining FDA approvals rather than the usual one about expiring patents, which always struck me as complete nonsense.
No word from the sages on this Board about the submission of the Phase 2 PEG data to the FDA and what the next move on that is likely to be. Presumably some discussions must be taking place on the likelihood of accelerated approval based on the Phase 2 data especially with the possibility of using an initial early analysis from the Phase 3 trial as further confirmation of the Phase 2 data prior to any approval being granted.
I was looking at the historical likelihood of approval figures in oncology on this site
https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf
It's quite interesting that in oncology there is only an 8.1% chance of going from a Phase 2 trial to FDA approval and only a 33% chance of going from Phase 3 to FDA approval. In solid tumours these rates decrease to 6.3% and 27.3% respectively. And in pancreatic cancer it looks from one of the charts that the figure from Phase 3 to FDA approval is only about 16%. I expect these figures would be even lower for companies of HALO's market cap.
So when analysts are now suggesting that PEG has a 60% chance of being approved for Pancreatic Cancer that is statistically significant!
Has anybody seen the Yang report on HALO? I see that Fezz has been tweeting about it so I guess it's even worse than usual. Please post a link if you know where to find it. Thanks.
I note that the Company has offered absolutely no opinion on how good the PEG data was relative to the possibility of submitting an NDA based on that data. If we are talking PFS then I'd say the data was excellent albeit on a small sample size. Obviously on OS, which is not a primary endpoint to the Phase 3 trial, the data doesn't really show a clear good trend. So if that's the case tell us that you won't be submitting the NDA for another 2 years or more. I can't believe that not a single analyst even asked the question.
Helen did say that they'd passed the data on to the FDA. What exactly does that mean? The FDA aren't going to do anything with it without a request. So is HALO going to ask the FDA's opinion? I'm not sure that the FDA is into offering opinions on whether to file or not. File and we'll let you know in 12 months. And of course HALO and the FDA have history.
In view of the market's general misunderstanding of the so-called 'cherry-picked' data and the disappointing royalty figures and the continued out of control unfunded PEG trial costs a little clarity might be a good thing and doesn't cost a penny.
Well that was one of the shortest rallies ever. Disappointing royalties yet again (is Shire selling any HyQ), out of control spending on PEG trials through to 2020 ($450m of which is still unfunded), three major Enhanze partnership failures including the world's biggest selling drug, and unconvincing messy data from the PEG Phase 2 trial culminating with most brokers only giving it a 60% chance of approval in 2020, have more than offset the so called Helen cherry picked headline news. The problem now is that 2017 will be a year of no major news other than SQ Mabthera approval in the US, which everyone says is a gimme. More patience required then - another 4 years worth.
So either they've badly missed their 2016 revenue projections or 2017 is a no growth year. That means that HyQ must be a complete bust - Baxter eh or now Shire! And maybe I've understated the unfunded $450m black hole by 2020. Either way they're spending money that they haven't got.
FOTD - pleasure - I only said it because it's true!
Anyway thanks for your views. There's been such a divergence of views concerning this data is it any wonder that the market is totally confused. It now appears that there is going to be a divergence of opinion on the prospects of Phase 3 success right up until the results are published - and Helen wouldn't say when that was likely to be. Our best hope for clarity would be if big Pharma started knocking on Halo's door.
Did you watch Helen Torley on Cramer's Mad Money last night? She came over pretty well considering she was being interviewed by Cramer, who understands little about what's been going on.
FOTD - what do you make of the arguments that have been raging today about the minimally statistically significant p-value of PFS and the non statistically significant OS data? The general feeling is that this level of OS relative to control in the Phase 3 would be unacceptable to the FDA - it's not exactly clear what the FDA mean by trending positive OS data is it? I'm not a statistician but why is the p value in the Phase1/2 only 0.048? It looked pretty impressive data to me so why the questionable p value?
Not sure what you are saying Fritz!
Bio - actually the results showed that PEG also worked better than control even on low HA patients, although of course it worked much better on high HA ones. This was one point that I was wondering about. In the Phase 3 trial all patients will be high HA and therefore nobody will be sure whether PEG works better than control on low HA patients.
One thing the trial did show was that the high HA percentage of patients was less than the previously quoted 40%. At today's conference call they said that they had always said 35-40% (I'm not sure that is actually true) but from memory the actual figures were between 30-35%. So with 65-70% of patients potentially excluded that's a lot of people that might still get some benefit from PEG. I wonder how this will be addressed. After approval will doctors use PEG 'off label' for low HA patients too?
Can the diagnostic tell exactly the HA level so anyone with a score of say 40 might still be a good candidate for PEG?
Anyway this all looks pretty good to me.
Well we all knew that the data would be muddled. The Phase 1 & 2 trials with the halt and introduction of the Ventana diagnostic were bound to lead to muddled data. But I do think that HALO's presentation of all the data was thorough and fair albeit confusing for those who can't be bothered to understand all the implications of the trial problems. So now the big bad news data that AF and AB are focusing on is the overall OS data being worse than control, which HALO claims is skewed by one control patient living much longer than expected. I guess the claim about how one patient in a very small trial can skew the data of course could also work the other way round. I would therefore imagine that there is no chance of HALO submitting an NDA based on this data and therefore we are in for a long wait - hence the market disappoint.
Adam Feuerstein calls the data cherry picked, muddled and shameful! That hasn't helped. Personally I thought they couldn't have given any more data - the full set was available for everyone to see. The only problem is that with the halt it is difficult to comprehend unless you put your mind to it. So why didn't anyone asked whether they were going to submit an NDA based on this data? I guess everyone thinks not.
Minninv - HALO certainly needs some good news on the Enhanze program after a hugely disappointing 2016. With Bococizumab, Rivipansel and Humira all having been dropped by Pfizer and Abbvie and the Keytruda trial having been held up by a halt for bleeding, the pipeline is looking decidedly weaker than it was 12 months ago. The much touted 150 potential target drugs for HALOisation just don't seem to be progressing at all. And Shire doesn't seem to be actively promoting HyQ yet for reasons only known to themselves. The only good news is that Roche have applied for SQ Mabthera approval in the US (at last) although surprisingly not for SQ Herceptin.
So what is the good news that you are expecting?
Minninv - it won't be the world's biggest selling drug Humira tragically. Abbvie halted that partnership due to futility. A potential $1b pa of royalties lost forever.
Oh boy - back into the 9s - and with all that great PEG news about to be released too. Maybe Roche is selling a few of its shares to lower the price just before making its offer to make it look better. That can be the only explanation, right?
Would you say HALO's stock price is behaving like a company about to deliver good or bad news? Everybody knows it's going to be not just good but great news right? Or am I missing something?