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Another 490k sold like an amateur by Kirky between 14-16 August. That run on his funds continues unabated. If he just needed cash for XON surely he’d have placed HALO shares with institutions.
So Kirky’s still dumping like a complete amateur - another 500k down to $17.08. This can only mean there’s a run on his funds. Old trusted clients wanting out now. Will this become a fire sale?
Looks like Kirky thinks it’s all hot air!
Kirky at it again. I wonder how low he’ll go today.
Yep - another 300,000 dumped by Kirky in a fire sale manner - down as low as $16.80. The guy is losing it. But contrary to the general assumption that he needs the money to fund the XON anti-shorting campaign I would have thought it much more likely that investors are withdrawing monies from his funds at an alarming rate as his golden touch is deserting him. He is thus a forced seller of HALO but this could be self perpetuating if the sales keep driving down the share price.
Institutions must be delighted that Kirky is dumping HALO in favour of the basket case XON. I have to say that he’s made so many billions why would he need to dump HALO at fire sale prices. What does he know that we don’t?
Kirky dumping again in a rather ineligant way. You’d have thought if he really needed the money he’d have a private placing rather than this ‘sell at best’ approach.
So how’s HyQ doing?
Just sold a few eh! And down into the 16’s too. Not the best timing from RJK.
So it appears from Roche that US doctors and hospitals are still causing problems about switching Mabthera and Herceptin from IV to SC. To hell with patients eh - so long as the doctors and hospitals maximise their profits. I’m amazed that the FDA don’t step to demand Roche to make these SC products fully available in the US.
So whatever has happened to HyQ. We were led to believe that this would be relaunched in 2018 when the new Baxter plant manufacturing Gammagard was opened. Yet another Baxter lie. The big question is whether all the other partnered products are going to be properly launched or whether they will do a Baxter and sign up HALO primarily so that it can’t develop rival products. This is the danger of signing exclusive contracts in particular indication areas. And what if a new drug takes over in that indication area? HALO could be excluded from doing a SC version of that drug and even if they could it would take 5 years to get to market by which time another new drug may have taken over as market leader. HALO could be endlessly playing catch up.
So maybe RJK has seen the flaw in the HALO model.
PEG combination trials take 5 years from start to finish. With things moving fast in the cancer world and new combination treatments seemingly cropping up every few months HALO has a problem. If it trials with a current standard of care drug and then during the 5 year trial period that standard of care drug is either knocked off its perch by a rival drug or a combination of drugs then the trial is effectively worthless. Isn’t that’s exactly what’s happening with PEG and Keytruda in their small cell lung cancer trial? Keytruda’s new three drug combination treatment is doing better than Keytruda alone so where does that leave the PEG Keytruda combination? Probably on the shelf. And surely this is going to continue to happen. If PEG can’t get approved in its own right but has to go through 5 years of trialing with each combination drug then it could be toast. Any views?
Roche has a long patent in the EU on the SQ version of Herceptin so I guess it’s just the worry that budget conscious EU medical authorities may prefer the cheap generic IV version to the more expensive SQ version. To hell with patient convenience eh!
Of course this is exactly the way that Roche has treated US patients where they haven’t bothered to get SQ Herceptin approved yet on the grounds that they will only do it just before the patent expires. I’ve always found that decision morally incomprehensible but Roche claims it’s the US doctors and hospitals that don’t want the SQ version because it will cut their profits (that long IV treatment takes more time and therefore more money for them).
It appears that patients take a very poor second place with everyone.
Regarding RJK’s departure from the Board this does seem rather strange. As far as I know he hasn’t resigned from any of his other directorships. The market clearly doesn’t buy into the takeover theory, which I had initially pondered about. Maybe Intrexon is about to make an all share offer for Halozyme!
Does anybody know whether Roche still have their Halozyme shares that they got at the time of the initial deal?
Yes if we hadn’t of raised and blown all those hundreds of millions on PEG our share price would probably be in the hundreds by now.
We still don’t have the retrospective analysis of the PEG results vs control in the high HA patients. If those results aren’t in favour of PEG then that would take some explaining.
Of course we’re all assuming that the PEG/Gem trial is being extended due to the PEG arm patients doing so well. What if it’s the control arm doing well like in Ffox trial? Just shows nothing is certain in the life of a HALO Investor. The PEG arm side effect issues also look worrying high in the Ffox trial, which led to a high drop out rate of PEG patients. What if that’s also happening in the Gem trial, which could explain the extended numbers. Lots to worry about eh?
What do you mean by ‘some paint job’ Fritz? Is this some technical trading or chartist expression, which seems to be your speciality? I’ve always wondered what ‘filling the gap’ means, which is one that you churn out every so often.
It certainly doesn’t seem to be the case with Cinryse - now with Shire. And Shire don’t seem to be doing much marketing of HyQ despite their usual comments about how wonderful it is.
I’ve been wondering about Humira. The haloised version of Humira has been dropped but does the fact that AbbVie signed up with HALO on Humira and paid HALO an upfront now stop HALO working with others in this space. I suspect it might. This has always been one of my concerns - big Pharma signs up a product with HALO but either drops it or doesn’t promote it - what is HALO’s position then if it could be working on a competive product in that space with another big Pharma. HALO deals are exclusive in a particular space but for how long if things don’t work out?
Because doctors and hospitals threatened to not use Roche cancer products if they started using SQ Herceptin because their incomes would decline. Profits before patients.
A couple of interesting questions in the CC about exclusivity. I hadn’t realised that once a big Pharma signs up with HALO on one of their drugs in a particular area then they have absolute exclusivity in that area for seemingly all time. This is potentially a problem to HALO isn’t it? Suppose a competitor comes along with a superior drug in one of those areas somewhere down the line. Then HALO can’t haloise that new drug because that area is taken. Also of course we could potentially have a Baxter type situation where a Pharma signs up in order to prevent other Pharmas in that area haloising their drugs but then decides not to market their haloised version (like HyQ or Mab/Herceptin in the US).
So will it be the usual today - disappointing royalties and no PEG news? At least there should be a profit after all the recent upfronts but the only thing we really want is PEG news. Whatever happened to those interim reports promised by Helen?
In my view Hyqvia is selling very little. HALO’s royalties certainly don’t suggest that much is coming from Shire. I suppose they are pushing their own in-house product Cuvitru rather than having to pay the 5% royalty on Hyqvia to HALO.
Does the Keytruda + chemo EMA withdrawal (rejection) in the EU have any consequences for HALO?
HALO fires COO Mark Gergen after just 12 months.
Good find biotechinvestor. Thanks.
Halo needs a few new Enhanze successes. It's been years since HyQ, SQ Mabthera and SQ Herceptin were first approved. Since then it's just been a string of failures. But it certainly doesn't look like there are likely to be any new approvals for at least a couple of years (other than SQ Herceptin in the US should Roche ever decide to put patients welfare before profits). We keep hearing about a hundred drugs that could be Haloised but in reality progress is painfully slow.
As I've been saying royalties have been lower than expected for years. I can only assume that Shire have effectively dumped HyQ at least for the time being. Why HALO have to be so secretive about the split of royalties between three products is beyond me. And how Roche can justify depriving US breast cancer sufferers of SQ Herceptin is an outrage. I can't believe that there aren't action groups out there demanding it. If ever there was an example of profits before patients that is it. Shame on you Roche and the FDA.
This is all one big never ending struggle. HALO never produces any nice surprises. Just consistently disappointing royalties and consistently higher than expected expenses. So much for the interim updates on HALO301. They can't even tell us how many patients have signed up or a likely date for the first interim update. As it's our trial we can say what we like - we just always choose to say nothing. If we ask a question about partners you have to ask the partner. Ask a question about HALO and they refuse to answer. Why do I always think that voluntary silence like this spells bad news? Did Shire ever release the long term Phase 4 study results on HyQvia? I can't seem to find them. Maybe there's something in those that would explain Shire's reluctance to effectively market HyQ or maybe they just like to market there own Cuvitru, which requires way more injections but to hell with the patients if you can save the 5% royalty. And this whole matter of Roche seemingly not seeking approval for SQ Herceptin is bizarre not to mention another example of to hell with the patients. I'm staggered that you Americans put up with it. But HALO doesn't seemingly care - so what if we should have been making another $50m a year selling SQ Herceptin - Roche is the client. I don't know why HALO don't force their hand by threatening to talk to the forthcoming biosimilar Herceptin pharmas. I suppose we can't for contractual reasons - same as we couldn't do other SQ deals on generic Cinryse and Gammagard, both of which are not patent protected. It appears you just pay HALO a few million dollars and you can stop them going to the competition. We are running into this problem too much. We should be making hundreds of millions in royalties by now on Enhanze products but we're not. OK so there's nothing on the horizon now this year except early stage trial results, which based on the recent 4 failures, aren't cast iron certainties.
Royalty revenues over the past 4 quarters have been $14.7m, $14.0m, $14.3m and $13.0m. Presumably pretty much all Roche - HyQ seems to be just about zero. Another Baxter anti-competition con - first Hylenex now HyQ.
It made me laugh when the CFO proudly said
"Yes, so we see this as kind of the beauty of our business model with the two pillar strategy. So the cash flow is coming in from the ENHANZE business. There is really two uses, two immediate uses. One is, we are funding our PEGPH20 program with that cash inflow and the second is, just a reminder that we are starting to pay down our royalty backed debt with 50% of the royalties that we receive in 2017 and then that will go to a 100% in 2018 and of course that’s subject to quarterly Cap"
The business model originally was that the royalty income would pay for all the in-house develop projects like PEG. Just to remind everyone the R&D expenditure in Q2 2017 was $38.3m. So the two pillar strategy is failing badly. But to bring it up as a wonderful achievement is a joke. It can barely fund a third of the R&D and therefore zero of the royalty loan debt.
Yep business as usual except they didn't get a milestone for US approval of SQ Mabthera. Wow!
Q2 Results - the usual lower than expected royalties (is Shire actually selling HyQ as there seems precious little evidence that they are) - out of control expenses due to funding numerous PEG trials all at the same time - no new partners (again) - no HALO301 news despite promised interim updates - but at least we have the Roche milestone for Mabthera US approval to reduce the massive losses slightly. Business as usual then.
It seems to me that using PEGPH20 in combination with various pancreatic cancer drugs can improve PFS by a couple of months although it appears that It may not increase OS by much if at all. Of course it only works on patients with high hyaluronan levels (less than 50% of all patients) and effectively just brings those patients to the same PFS and OS levels as non high hyaluronan patients. So it's not a cure, it just extends PFS in some patients by a couple of months but doesn't make them live any longer. Aren't we all getting somewhat carried away with this drug. I'm not convinced that insurance companies will be prepared to pay silly money for it but HALO is certainly spending silly money paying for all the trials. It is also at high risk of being replaced by any new pancreatic cancer drugs developed in the future. Any views?
So get SQ Herceptin approved and on the market and well accepted in the US well in advance of non SQ biosimilars. I just don't get the point of delaying.
Not that I know of. But this is HALO. There's always some disaster just around the corner.
So why don't Roche get SQ Herceptin approved before biosimilars are approved? It's beyond me.
And OS?? Total silence. There's no way the FDA will approve PEG unless the OS figures show a positive trend, After all this time we have to assume that they don't. How long can they hide these figures, which must be known. They must be withholding them in the hope that the Phase 3 figures will show a positive trend - in the meantime they are spending money like water on numerous PEG trials.
"There are now 268 combo trials involving Keytruda and 242 with Opdivo, of which 86 combine Opdivo with Yervoy. Keytruda’s dominance comes as the drug continues to impress in clinical trials
The number of studies combining anti-PD-1/PD-L1s with chemotherapy have surged, potentially spurred by Roche’s efforts with Tecentriq
The most popular indication for combinations is lung cancer, which makes up the biggest single market (16%), followed by melanoma and sarcoma (13%), which has so far showed the best efficacy for PD-1/PD-L1s
IO-IO combos also represent a significant part of the analysis. Keytruda, Opdivo and Tecentriq are in 56, 54 and 32 IO-IO combo studies respectively"
So HALO is involved in some of these combo trials. Let's take PEG and Keytruda as an example. What happens if a combo of Keytruda and another drug proves to be better than Keytruda alone. Where would that leave the PEG and Keytruda trial? On the shelf probably. HALO would then need to do another trial combining PEG with the other combo. This could be a never ending drain of an already huge potential black hole.
Interesting very detailed post on HALO on seeking alpha today.
https://seekingalpha.com/article/4075826-halozyme-pegph20-clinical-development-progress-yet-translate-value
I see the poster's black hole projection of $500-600m is even higher than mine - and nobody believes me!
FOTD - I'd be interested in your take on the post. There's a lot of interesting stuff in it.
They couldn't even wait until the SC Mabthera approval - too risky eh! Well at least that's $120m in the bag. Just another $330m required to see them through to profitability in the 2020s.
What about this from the CC
"So as further reported, that a high rate of death was observed in the PEGPH20 treatment arm versus the modified FOLFIRINOX lone arm"
This has never been reported before. This could be a disaster from the whole PEG program. Why would there be a high rate of death in the FOLFIRINOX/PEG arm versus the FOLFIRINOX arm? This is very hard to explain and Helen's answer yesterday was just a fob off.
Here's Fezz's spin on royalties
"fezziwig2008 @fezziwig2008
MabTheraSC is Now in 41 Countries- added 18 this Q- promising for $HALO royalties going forward. @Roche"
So why are royalties down from last quarter?
So as I said - a typical HALO quarter. Royalties were actually down Q1 2017 v Q4 2016. That was a shock even to me. The rest of my predictions were correct. Nothing to report of any note. Fund raising for sure after SC Mabthera approval.