Halozyme Therapeutics Incorporated (HALO) 시세

Thanks for posting that. Hope all is well with you as the catastrophe continues.

Jan 8 note from JPM:

"We came away from HALO’s guidance call impressed by the momentum and profitability of the company’s Enhanze royalty portfolio with ‘24 guidance maintained and top- and bottom-line guidance raised for 2025-2028. We see better than expected growth for Vyvgart as a key driver of the 2025 guidance increase along with better than expected performance from Darzalex Faspro and Phesgo. While HALO also expects to see royalties from three new launches, Ocrevus, Tecentriq, and Opdivo, the more meaningful royalty contribution from these products will come in 2026. HALO also announced a new $250mm accelerated share repurchase under the existing $750mm program given management’s confidence in the company’s cash flow and speaking to the lack of an identified near-term M&A opportunity post-Evotec. While many expected a bump to 2025+ guidance after management raised 2024 guidance with 3Q results, we still welcome the lift in guidance driven by better than expected growth in key partnered products. Still, we would like to see more deals with new or existing partners with good economics and broadly more long-term visibility to get more constructive.

Other tidbits. Management is still waiting to hear from the USPTO on the extension of the US LOE for Enhanze, which should extend the Enhanze LOE into 2029 (without it, US LOE is in Sept 2027). This has not been incorporated into management’s forecast and would provide incremental upside when it does (our model assumes this already).

It was at CheckMate-6GE. (2.25ml)
The AI option is with the partner. This means that the next partner may choose Halozyme's AI. If this happens, YPSOMED will fail to invest in production facilities. We can guess that MSD will approach YPSOMED.
???? ???? ?????. ??? ??????

As far as I remember, BMS also clinicalized Opdivo with YPSOMED products. all syringe companies have their own patents, and injection devices are difficult technologies. However, injection equipment companies are overflowing, and it's important that there are only two hyaluronidase suppliers, Alteogen and Halozyme. The difference between Halozyme is that it injects 10ml in up to 30 seconds.

There is no need to be disappointed that Vyvgart does not use Halozyme's AI. Before Halozyme developed the AI, the clinical trials of Vyvgart AI were already starting

I looked at all the figures you mentioned in your post. Not sure what you are trying to say. Can anyone decipher his cryptic post? The genius can only communicate via clues and hints.

If your point is that Argx is not using halo's AI, yes, I agree. I already posted that I stand corrected thanks to Pioneer's post.

What I don't understand is how is Argx would not be infringing on halo's HVAI patent if they are putting halo's enhanze in someone else's injector. Companies are free to use any autoinjector they want but the combination of Enhanze and an Autoinjector for high volume  is unique and protected by halo's patent. Perhaps Argx will pay halo for licensing the HVAI patent.

PD96, thanks for pointing that out. It was instantly obvious seeing the picture it was an YpsoMate AI. FWIW, posted an article of the current large volume AIs some months ago for fellow investors, and the YpsoMate was listed, as is typical the info was belittled. Been following the trial for a while and was wondering what AI was being used, figured it wasn’t HALO’s AI, since it was never mentioned in a PR. Selecting the YsopMate over HALO’s, is very disappointing, since HALO clearly had a suitable AI, as shown in Fig 150 of the HVAI patent, bi1 is always mentioning. At least there are several other small volume AI in the development stage, with high potential as being a HALO AI.

Speaking of bi1…..Really….. “.still not sure how Argenx could do HVAI which clearly involves rhuph20 with another autoinjector without licensing it from halozyme. Here is the relevant patent for using rhuph20 with an autoinjector for volumes higher than 3ml:”

BI1, just what do you think the HVAI is for, not the one in Fig 150 which could have been used by Argenx, but the one in Fig 154, which is truly a large volume AI, as is the injector in the new patent filing posted on the AU site. Here are some hints: comments directly from the patent, to be used along with the reference in the FTR posting the other day.

Patent 12178860….Hyaluronidase enzyme formulations for high volume administration

“In one embodiment, the flange 20 may be couplable to a tubing set 21 (as shown in FIG. 166) in fluid communication with the medicament in the container portion 16.”

“FIG. 166 is a perspective view of the button actuated auto-injector coupled to a tubing set in accordance with a fifth exemplary embodiment of the present invention.”

“Referring to FIG. 166, there is a fifth embodiment of the injector 10 shown. The injector 10 may be similar to the embodiment of the injector 10 shown in FIGS. 154-161 except that the flange 20 may couple to a tubing set 21 for applications where a needle 19 may be insufficient or inappropriate for delivery of the medicament. The plug 54 may be removed prior to the tubing set 21 being coupled to the luer lock. The tubing set 21 may be threadedly coupled to the flange 20 to establish fluid communication therethrough.”

And in the new AU patent filing… AU2023430176 - BUTTON ACTUATED AUTOINJECTOR

“[0056]   In one embodiment, the flange 130 may be couplable to a tubing set (not shown) in fluid communication with the medicament in the container portion 126.”

...still not sure how Argx could do HVAI which clearly involves rhuph20 with another autoinjector without licensing it from halozyme. Here is the relevant patent for using rhuph20 with an autoinjector for volumes higher than 3ml:

method comprising administering to the subject via subcutaneous administration about 3 mL to about 50 mL of a formulation comprising a therapeutically effective amount of an active ingredient selected from a small molecule, a peptide fragment, a biologic, a nanoparticle, an antibody, an antibody fragment, and a small molecule antiviral, wherein the subcutaneous administration occurs via a high volume autoinjector with a starting delivery force of about 3 lbf to about 50 lbf, an ending delivery force of about 5 lbf to about 20 lbf, a starting pressure of about 50 psi to about 200 psi, and/or an ending pressure of about 20 psi to about 75 psi. In one embodiment, the formulation further comprises a hyaluronidase enzyme.



https://patents.justia.com/patent/12178860

Pioneer, welcome to the board. Thanks for your informative post. Who do think hlao is likely to sign the first HVAI with?

You are right. I stand corrected. The syringe does look like YPSOMED 5.5 too. 

That's disappointing. I think Helen said above 5ml is HV and cannot be done (delivered rapidly) without ENHANZE. It looks like Argx is using Enhanze but putting (Vyvgard Hytrulo which includes Enhanze) in YPSOMED autoinjector. But halizyme now has a patent (as of late last year) for HVAI !!!!

They will always have something to complain about.
It's a disorder.

?????. ? ???? YPSOMED? YpsoMate 5.5 ???.

Agreed. I think we know what's cooking now. HVAI deal is what we have all been waiting for. Not delivering on it is what's held valuations at bargain PE ratios deapite the magnificently growthing earnings. 

With this ARGX leak, don't be surprised if we have a sustained run back to 60's and likley hit new all time highs once the official announcement is made.

Also, remeber that the HVAI has its own brand new patent that was issues late last year. So the permabears who always remind us of patent expiration after 2029 and plateauing of earnings, will have nothing left to complain about.

No back pressure. Sounds very familiar. I’m going out on a limb and say it looks like Halo has an HVAI deal with argenx in the works. Nice find!!!!!

Zoom in on the AI syringe, page 11 on their (ARGX) presentation (see link below). It shows the same concentration (2000 units/ml) as the vial. This means to get the normal dosing of 11,200 units, the AI has to deliver 5.6 ml. This is considered high volume and is impossible to deliver rapidly without Enhanze and halo's patented HVAI. 

I thought Roche might be the first company to sign a HVAI deal with halo. But it seems Argx beat them to it.

https://argenx.com/content/dam/argenx-corp/events-presentations/argenx_Corporate_Presentation_Sept_2024.pdf

Today was all because of Argx. Very impressive results. Curious about AI program in 2027 and if Halo involved.

Agreed. But Argenx reported Vyvgart Q4 sales of $737m, way above expectations. I imagine this is helping halo’s stock action.

... something's cookin

Not sure what world you live in, but halo went from $48 to now $53 since they announced the investor conference. And this while XBI and the overall markets have absolutely been horrible


Take your permabear glasses off.

It's clear Helen's PR stunt last week failed to impress. The excuse that deals are not happening because of tight money is preposterous. Significant deals are popping off every day in biotech. By now, most investors are truly tired of Dr. Torley's failure to deliver.

...and yet, the stock is in the green. Something is brewing.

Wells Fargo lowers PT from $62-$57, maintains equal weight.

Nasdaq, S&P and XBI are all down significantly. No one would have been surprised if Halozyme $halo was down too. Yet, it's green. Something brewing with HVAI? Hunkered down to put the finishing touches on an HVAI deal instead of attending JPM conference?  

Nasdaq, S&P and XBI are all down significantly. No one would have been surprised if Halo was down too. Yet, it's green. 

Something brewing with HVAI? Hunkered down to put the finishing touches on an HVAI deal instead of JPM conference?

Thank you.

Thank you.

The facts are there for all to see and Helen's leadership is not on the positive side of the ledger. It seems her continued position as CEO is increasingly being seen as a problem by the analyst community.

Best of luck to you. Stay safe.

My prayers are with you. 

It’s really hard to understand these analysts. Do they not pay attention to facts?

JPM maintains neutral rating also. I am dealing with one of the LA fires but I will try to post in the next few days.

Piper Sandler maintains neutral rating, raises PT $52-$53. Clearly, Joe Catanzaro, who's followed HALO for a very long time, is not impressed by Helen's empty promises. I'd love to read his notes if anyone could post them.

Be grateful for this market giving you an opportunity to load up more of halozyme at these prices. This whole week has been pretty rough for the indexes. Otherwise halo would already be in high 50's to low 60's. Take advantage. We are lucky!

$HALO 2025-01-10 13:12:00 GMT DJ Halozyme
Therapeutics Price Target Raised to $70.00/Share From $68.00 by HC Wainwright & Co.

"Several internal products in development"? Say more please. That sounds great.

FTR:.......Things just takes time…..just look at Selatogrel, first PR in Nov-2019, and per Viatris, estimated to hit the market in mid-2027, as a “blockbuster drug.” .....Selatogrel will be a MAJOR addition of income to HALO for years, (which was a major reason for buying ATRS).……The following are obvious at this time:…… HVAI is for TAK-881 kit…… a few of the small AI deals mentioned,….some of the additional Enhanze deals…...as well as several internal products in development…..…things just take time.........next step M&A….....Dr Torley knows how to grow a business....…the future is up……way up.....!!!!!!

1/8/25 TD Cowen raises target price for halo from $70 to $77

Agreed that we could conceivably hit the triple digits if only HALO was capable of stringing together a couple of significant deals. Helen's Happy talk, and now the recent lame excuses, will not cut the mustard any more with impatient investors, nor should it.

I listened to the call. What you say is accurate. All that Me and Fred are saying is the market has been hearing lots of talk and no results yet on topics 1&3 and that is holding the price back. Once that clears we could easily get into the hundreds. Hopefully Helen is capable of talking us to that next
Level. I’m not giving up but a lot of time has passed.

If you had actually listened to the cc today, you would have heard (and still can if you listen to the archive) that the current projections (the graph you speak of) does not include the addative revenue/EPS from A) US patent is extended or B) later wave products from existing partners/programs are approved. 

Yes, reason number 3 from my previous post  (HVAI or new parterships) is not in the bag yet and you can call it speculation. I would call it future highly likely catalysts. Reason 1 is not in the bag yet either but EU granted the same patent extension and it is highly unlikely that US won't.

Reason 2 is in the bag and is not a speculative whatsoever.

Helen's own graphs from today's presentation support my position. Anything that deviates from that is speculation only.

When all of that happens no problem. But the market is not convinced. The reason I say that is because talk is cheap and there’s a lot of talk.

That is incorrect for the following 3 reasons:

1) US and EU Enhanze patent extensions to 2029

2) Waves 2, 3, 4 and 5 Enhanze products with co-formulation patents effective well into 2030's will ramp up and more than offset decline (step down) in royalty from Darzelex. You are forgetting or intentionally ignoring the coformulation patents which will protect mid-single digit royalties (i.e. avoid royalty step downs). Pretty much all Enhanze contracts with the exception of Darzelex have terms that protect royalties if there is a coformulation patent even when the stand-alone Enhanze patent expires in 2029.

3) We will have HVAI as well as more Enhanze deals.

The impressive year over year revenue increases hit a wall in 2028. That is what is holding the pps back.

... even without a new deal, halo's de-risked/proven earnings growth (conservative CAGR of 20-30% through 2029 with the expected US patent extension) with the existing partners and profit margin of 60-70% support a PE of at least 20. We are currently (with the recent run up) at a 2024 PE of 13 (see link below). 

So unlike you and the permabear duo on this board, I'm of the opinion that even without a new deal, we will be back to the $60's in short order (barring a market or biotech crash). Feel free to call that a "drift" again if you want!

With HVAI deals, halo will be securing earnings growth CAGR through 2030's. HVAI is brand new technology and the patent was issued just last December. With HVAI deal in the bad, $halo will be "drifting" to triple digits.

https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios

Your "drift" prediction was right after one of the earnings calls last year. It was not "very accurate" at all simply because the stock went up more than 20% and hit a new all-time-high shortly after your post. You later claimed that the run up was due to momentum traders and had nothing to do with the impressive earnings beat and raised guidance.

The stock dropped from the mid $60's mainly due to the Evotec buy-out fiasco which by the way you were a big cheerleader for. Unlike you, majority of market participants disliked the idea and punished the stock for it.

I agree that the pace of deal making has been slower than we all expected and what Helen had promised in 2023. I have been critical of her about it. I do agree that we will be much higher once we get new deals, especially HVAI.

I would expect that. This stock has drifted since my very accurate comments months ago that you disputed. Until the strategy of spending 1b on Antares is confirmed by new deals the stock won’t fly like we all think it should. That’s why we trade at a low multiple.

Expect analyst upgrades

Her explanation of the lack of execution of new deals was not believable. She blamed lack of financial resources on the part of Big Pharma, which is causing them to go slow, an absurd excuse, IMHO.