Halozyme Therapeutics Incorporated (HALO) オプション

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Thank for this. I know I’m biased but Jason Butler has been following Halo a long time. He knows what he’s talking about and always has a higher target. And he’s right.

In a report released today, Jason Butler from JMP Securities reiterated a Buy rating on Halozyme (HALO – Research Report), with a price target of $73.00.Don't Miss our Black Friday Offers:Unlock your investing potential with TipRanks Premium - Now At 40% OFF!Make smarter investments with weekly expert stock picks from the Smart Investor NewsletterJason Butler’s rating is based on several considerations, primarily highlighting the robustness and continued prospects of Halozyme’s ENHANZE technology. Despite the emergence of potential competitors, such as Merck’s new subcutaneous formulation of Keytruda, Butler maintains confidence in Halozyme due to the company’s established reputation and comprehensive intellectual property portfolio. He suggests that Halozyme’s partners will likely continue to see ENHANZE as the industry standard, given its proven track record in manufacturing, development, and regulatory compliance over the years.
Furthermore, Butler suggests that the impact of new competitors on Halozyme’s royalty streams and pipeline potential is minimal, especially considering the forthcoming PDUFA date for Bristol’s subcutaneous OPDIVO. The analyst also notes the strategic importance of Halozyme’s new MDASE platform, which could serve as a superior alternative to ENHANZE. Overall, Butler’s Buy rating reflects his belief in the company’s enduring competitive advantage and its compelling value proposition for partners.

https://www.tipranks.com/news/blurbs/halozymes-competitive-edge-butlers-buy-rating-amid-emerging-competitors

X

100% spot on in all respects. Thanks for sharing that.

Agree, these comments make a lot of sense, especially this part:

introduced investor questions around why HALO would pursue something seemingly so divergent from its current business.

Thank you very much for sharing this analysis, Maumar.

But if the MDASE patent portfolio is as broad and all-encompassing as Helen says it is, then the elephant in the room is a patent infringement suit filed by Halozyme against Alteogen. Jessica Fye did not mention this possibility.

-- OJ

P.S. Breathing a sigh of relief that this EvoTech deal is not going ahead. Helen seems more and more like a loose cannon. Agree with Jessica Fye that the best thing HALO could do right now would be to announce a new partnered subQ product, demonstrate commitment to its business model and related stability of future income streams/EPS.

Thanks for sharing. JPM analyst has not been on top of her game over the past few months. She made some silly calls that were proven unwise in retrospect. 

Regarding JPM's most recent view, I don't see Helen moving too quickly to buy another company. She (Helen) learned a valuable lesson here.  I hope/think she will wait until she has an HVAI deal in the bag before shopping around again.

Roche likely working on HVAI with enhanze. See slide 64 on this Roche slide deck. Note Roche made a distinction between on-body injector and high-volume autoinjectors (halozyme) https://assets.roche.com/f/176343/x/f513f69de2/pharma_day_20240930_final_online_v02.pdf

I think her comments make sense. From JPM's Jessica Fye:

HALO announced this morning that the company is withdrawing its proposal to acquire Evotec due to the target’s unwillingness to engage. We believe HALO was initially attracted to Evotec’s potential to offer durable, de-risked revenue, potential for attractive margins, and similar business model. Still, the bid was unexpected given the significant difference between the two companies (see our initial take here) and introduced investor questions around why HALO would pursue something seemingly so divergent from its current business. Indeed, at one point HALO had lost >$2bn in mkt cap since last Wednesday’s close (the day before the Evotec headlines emerged), similar to the proposed deal size. While we expect HALO retracting its bid will come as a relief, we believe it could take time for HALO shares to fully recover, and based on our investor conversations, we think this proposal has introduced uncertainty around what other deal proposal might be next, in addition to what the pursuit of Evotec suggests about HALO’s long-term outlook. Bigger picture, while we are encouraged by the growth of HALO’s currently partnered subQ products, we would like to see more deals with new or existing partners with good economics and more visibility on Wave 4/5 products to get more constructive.

Monitoring recent developments with Alteogen. We have been watching developments with Alteogen and its berahyaluronidase alfa (aka ALT-B4, a hyaluronidase variant). Merck recently announced positive top-line results for subQ Keytruda using Alteogen’s ALT-B4. Recall that Bristol secured exclusive rights to use Enhanze with PD-1, and the PDUFA for subQ Opdivo is Dec 29th. HALO recently unveiled its portfolio of MDASE patents, which broadly cover modified human hyaluronidases for potential use in subQ delivery of drugs/biologics. These MDASE patents are distinct from the Enhanze patents and essentially cover various alternative hyaluronidases . While we have yet to hear HALO explicitly state whether it believes ALT-B4 may be covered by the MDASE IP, broadly speaking, we believe HALO aims to leverage this IP to capture royalty economics on hyaluronidase-containing products that don’t use Enhanze, and we will watch for how successful this may prove. We also noticed that Alteogen recently entered into a deal with Daiichi Sankyo to develop subQ Enhertu (HER2 ADC). Recall that Roche utilizes Enhanze for its SubQ HER2 products Herceptin SC and Phesgo (subQ Herceptin+Perjeta combo).

Upcoming catalysts:

US patent extension for Enhanze

BMS Opdivo SC approval PDUFA date in December

Milestone payment(s) for new Argenx trials in Sjogran's trial

HVAI deal with Roche (Roche hinted at it in their investors slide deck)

MODERATE Fred.

Centerview Partners is serving as Halozyme's financial advisor and Weil, Gotshal & Manges LLP, as legal advisor.

I wonder how many millions of dollars we paid these experts for this train wreck?

You are wrong again. It's clear that it is you who does "not know how things work." If evo was truly a good fit, and the investors had supported Helen's idea to buy it, Helen would not have withdrawn so quickly. She would've raised the bid to see if Evo board would engage or use other means for a hostile takeover clearly no one thought this was a good buy for Helen and she withdrew.

I like how you were proven wrong on the way down and now on the way up and you still insist.

I hope I’m right but I see what you’re saying to an extent. Read my post that I made to Bio and you’ll see what I think. When I invest I always bet on the CEO. Buying companies as a strategy sometimes works and sometimes doesn’t. By waiting for the right deal she is doing the right thing. That being said I would like to see more partnerships.

I don’t think you really get how things work sometimes. As an experienced business operator who has merged companies in the past Helen’s decision to walk was the right one to make because she knows as well as I do that there has to be chemistry between upper mgmt and clearly there was not. You or I should have never even known that Helen was exploring this combination until it was agreed on. Someone on Evo side purposely leaked this to crater any hope that this will happen. In the meantime there has been damage done to Halo and their stock price at least for a while. She is approaching deal making in the appropriate manner and you have consistently bashed her for how she runs the company in spite of the great success thus far. I still think the buybacks and the Antares deal were good for the company and accretive. In reality Halo paid a net price of about 7-8 hundred million for an injector platform and commercial products that generate cash flow. At some point she’s going to sell off the commercial business and get most of the cash back that she paid and get the injector business for pretty much nothing. Let’s she what she can make of it. I also think she had the right idea on Evo but we’ll never know.

This is where we part, Howee, she's had the benefit of the doubt for far too long. The leak has nothing to do with the failure to execute new deals, with EVO or otherwise. She's been riding on the coat tails of the success of her processors and has shown us that she just can't grow the company with new partnerships. Time to move on.

Don't forget that she could have let her ego get in the way, double down and raise her bid for Evotec. Instead she showed discipline and listen to her investors. This will bode very well for future of halozyme. It shows her management is pragmatic and not driven by ego. I'm glad I bought more on the dip (see my multiple posts over the past week) that I was buying.)

This whole episode was a great test of Helen and the posters here. Congratulations to the longs who saw Evotec for what it was and still had the fortitude to buy at the dips.

I have been critical of Helen, but she just gained much respect from me. Thank you for showing discipline, Helen and listening to your true investors.

Nearly everything you said in this post was wrong. Your posts over the years have shown us that you are a permabear on halo. There is little doubt on this for anyone who has been here.

Howee's posts like the one in favor of the deal because it would be good for Evotec's employees or because Evotec on its has doone little, or his post about Halozyme paying Deutsche Bank to downgrade Evotec and many others makes little sense. Not sure if one should take his posts seriously or if he is a closet bear.

Too bad IH won't let you delete this and other posts you wrote un favor of the deal and predicting that it would take place. Same goes for Stock Rafter.

I’ll give her the benefit of the doubt. We would have never known about this except for the leak. That was clearly done as part of Evo strategy to avoid this deal and Helen was forced to come out with the news. Pretty shady on Evos part but it worked.

Goes back to what I've been saying for two years. Helen is not a deal maker. She needs to go.

Deal fell apart, so we were wrong. LOL!

The minute I talk they walk. Congrats to bio on this

Thank God it's over. See PR

https://x.com/NuntioBot/status/1859953967171555731

Thank you for clarifying!!!! You are much better than I am at communicating. That’s exactly what I’m thinking.

Decades before you arrived here with your omniscient wisdom, Howee was long HALO. I know because I've been here. Also what he said makes perfect sense, as usual. EVO is trading like the deal goes through. I said at the beginning of this messy saga that EVO BOD and management are going to want to share power in the new entity and weren't going to just walk away into the moonlight. I think a power sharing agreement is in the works and if HALO's board and front office are expanded as a result it will be a good thing in the long run. Anything to put more eyes on Helen and weaken her grip on the current ineffective sleepwalking BOD will get my vote.

Now why would it be good for halozyme investors if halo buys a company that as you say "on its own has basically done nothing"? Are you sure you are long Halozyme?

You say "may be the deal is better for the employees." I assume you are referring to Evo's employees. Then again, as a Halozyme investor, I want what's best for halozyme and not what's charitable to Evo's employees. I am not sure if you are truly bullish or long on halozyme. Can't take your comments seriously. 

Right about now the evo execs are trying to make themselves a sweetheart deal. The stock is trading as if a deal is going to happen. It would be 4 if the market thought it was dead. Maybe this deal is better for the employees. Did you ever think that might be the case? Evo on its own has basically done nothing. Well know soon enough.

From another poster: “Evotec has already said no thanks. Wall Street said no thanks. When Halozyme management says ok forget about it, we go up $10. We are waiting Ms Helen.”

from another board: “Why stick with buying a company who is hostile about the takeover? What's to gain?
Disgruntled employees and managers in a foreign country? Somebody do something. Wall Street has spoken. Down $20 from highs.”

MDASE IS not just one patent. It's a whole portfolio of patents for hyaluronidase modifications. For you to say that you know Alteogen's patent came before MDASE, you must know all the patents included in MDASE. Do you? Please share the patent numbers.

Helen Torley

?

All right, and maybe I'll take a step back and just say, you know we talked about all of the experiments that we did, and the experiments that we did on the human hyaluronidase area, and we came up with ENHANZE that we patented and that's a truncated human hyaluronidase. But we also did lots of experiments, thousands and thousands of experiments on different structures of hyaluronidases, and we called those our modified hyaluronidase.

?

So ENHANZE has got one structure, the modified hyaluronidases have different structure from ENHANZE. And when we have licensed ENHANZE, we are only licensing the IP to the structure and the activities that are related to that specific ENHANZE structure Mohit. So that's why our partners are not upset or surprised or anything, because they are totally different products and patent portfolios firstly

This right?

By timeline, I know that Halozyme's variant hyal- patents have been registered since Alteogen's patent application.

According to HALO's CLO, halo has done over a thousand experiments with hundreds of variants many years ago. Halo's introduction of MDASE means they will likely challenge alteogen'a patent if Alteo doesn't pay licensing fees.

They cited Halozyme's original patents in the patent document, stated that there was no information about the variant anywhere, and received a registration license code(NOA)
And also Merck & Daiichi has have legal teams.

Found it here:

https://ppubs.uspto.gov/pubwebapp/


Not sure id that'a going to protect Alteogen

https://globaldossier.uspto.gov/details/US/16628258/A/117911

So you have the correct number? Nothing came up on USPTO.gov with that number

Alteogen's patents do not violate MDASE.
Search USTPO 16628258.

Brand new Bristol study with Enhanze:

https://clinicaltrials.gov/study/NCT06697197?intr=rHuPH20&sort=StudyFirstPostDate&rank=1

Merck could not go with Enhanze because BMS has an exclusive contract for Opdivo SC with Halozyme.

It's been known for years that Keytruda SC can never be with Enhanze due to the exclusivity mentioned above. So this is not news at all.

What is recent news is that through newly announced halo's MDASE licensing, Alteogen will likely pay Halozyme for something that was not projected previously to contribute to revenue/EPS (i.e. Keytruda SC)

If it ends up going to court and halozyme wins, Alteogen will pay for halo's legal fees and then some.

Either way it's a win for halozyme.

Helen has already fixed the competition problem. Just re-define "mid-single digits" to include 3%! Voila!

How do you figure, good for EPS? In my world, this is telling the entire Big Pharma world that Halozyme has a viable competitor in Alteogen making a viable competing form of hyaluronidase. It's encouraging would-be new partners (Novartis, AbbVie, Astellas, GSK, Astra-Zeneca, etc.) to drag their feet and resist Helen's attempts to persuade them to sign the dotted line and commit to long-term collaborations. It may also exert downward pressure on the "mid-single digit" royalties Halozyme has become accustomed to receiving under terms of those deals.

For Helen to neutralize this threat, she will have to file a patent infringement lawsuit against Merck & Co., Inc., one of the largest multinational pharmaceutical corporations on the planet, and she may have to file it in more than one jurisdiction internationally. This seems like it could be a costly and time-consuming distraction.

Sorry to sound so negative. Clearly the market doesn't agree with my analysis, as the share price for HALO is climbing today.

Personally, I had been hoping that Merck/Alteogen's trial of SC pembrolizumab would crash and burn, driving Merck and many other BP's into Helen's arms.



-- OJ

Did they assume no deal?

HC Wainwright & Co. Reiterates Buy on Halozyme Therapeutics, Maintains $68 Price Target

Very nice. Thanks for sharing.

This is positive for Halo if/when Alteogen pays for MDASE license or Halozyme compells Alteogen to do so in patent litigation.

Either way, it is postive for EPS growth.

ARGX Advances Clinical Development of Efgartigimod SC in Idiopathic Inflammatory Myopathies

https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/94954309/form-6-k-report-of-foreign-issuer-rules-13a-16


- Phase 2 data establish proof-of-concept of efgartigimod SC in myositis



- Enrollment to continue in Phase 3 across all three subtypes (IMNM, ASyS, DM) under evaluation in ALKIVIA



- Potential for efgartigimod SC to be first targeted approach for myositis patients who have limited treatment options



November 20, 2024, 7:00 AM CET



Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the decision to continue development of efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in the ongoing Phase 2/3 ALKIVIA study in adults with idiopathic inflammatory myopathies (IIM or myositis), following analysis of topline data from the Phase 2 portion of the study. ALKIVIA will continue to enroll patients across each of the three myositis subtypes in the study, including immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM).



“Efgartigimod SC continues to show its promise for patients suffering from chronic autoimmune diseases,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer of argenx. “Idiopathic inflammatory myopathies are debilitating diseases that can cause muscle weakness, affect multiple organs, and have a severe impact on patients’ quality of life, including increased morbidity and early mortality. We are excited to continue the development of efgartigimod SC across all three subtypes, allowing us to explore the broad potential of this precision therapy for those whose needs remain unmet by current treatments like steroids, plasma-derived therapies, and broad immunosuppressants. We are grateful for the patients and investigators participating in the ALKIVIA study, and hope to bring efgartigimod to patients living with myositis as soon as possible.”



The decision to continue clinical development of efgartigimod SC in each of the three myositis subtypes is supported by the efficacy and safety results from the Phase 2 portion of the seamless Phase 2/3 ALKIVIA study. Overall, the study met its primary endpoint, demonstrating a statistically significant treatment effect in mean total improvement score (TIS) at Week 24, and showed improvement across all six core set measures of the TIS in favor of efgartigimod SC compared to placebo. The observed safety and tolerability profile was consistent to that demonstrated with other clinical trials.



ALKIVIA Study Design



The ALKIVIA study is a randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of idiopathic inflammatory myopathies (IIM or myositis) across three subtypes, including immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and dermatomyositis (DM). The ALKIVIA study will enroll 240 patients in total and is being conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 90 patients completed the study, followed by a Phase 3 portion if a signal is observed in the Phase 2 portion. The primary endpoint is the mean total improvement score (TIS) at the end of the treatment period (24 weeks in Phase 2 and 52 weeks in Phase 3) of all treated patients (IMNM, ASyS, DM) compared to placebo. Key secondary endpoints include response rates at the end of treatment, time to response, and duration of response in TIS, as well as change from baseline in individual TIS components. Other secondary endpoints include quality of life and other functional scores.









About Idiopathic Inflammatory Myopathies



Idiopathic inflammatory myopathies (myositis) are a rare group of autoimmune diseases that can be muscle specific or affect multiple organs including the skin, joints, lungs, gastrointestinal tract and heart. Myositis can be very severe and disabling and have a material impact on quality of life. Initially, myositis was classified as either DM or polymyositis, but as the underlying pathophysiology of myositis has become better understood, including through the identification of characteristic autoantibodies, new polymyositis subtypes have emerged. Two of these subtypes are IMNM and ASyS. Proximal muscle weakness is a unifying feature of each subtype. IMNM is characterized by skeletal muscle weakness due to muscle cell necrosis. ASyS is characterized by muscle inflammation, inflammatory arthritis, interstitial lung disease, thickening and cracking of the hands (“mechanic’s hands”) and Raynaud’s phenomenon. DM is characterized by muscle inflammation and degeneration and skin abnormalities, including heliotrope rash, Gottron’s papules, erythematous, calcinosis and edema.



About Efgartigimod SC



Efgartigimod SC (efgartigimod alfa and hyaluronidase-qvfc) is a human IgG1 antibody fragment designed to reduce pathogenic immunoglobulin G (IgG) antibodies by binding to the neonatal Fc receptor (FcRn) and blocking the IgG recycling process. Efgartigimod SC is the first-approved FcRn blocker globally and is marketed as VYVGART® Hytrulo in the United States and China for the treatment of generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP), and as VYVGART SC or VYVDURA (Japan) for gMG in other regions globally. Efgartigimod SC is currently being evaluated in more than 15 severe autoimmune diseases where pathogenic IgGs are believed to be mediators of disease.



About argenx



argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker, globally in the U.S., Japan, Israel, the EU, the UK, China and Canada. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube.



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Ben Petok

bpetok@argenx.com