Halozyme Therapeutics Incorporated (HALO) News

.... clouds are parting and blue skies ahead. As explained in the earlier post, none of the stuff with Alteogen or MDASE have any effect whatsoever on the EPS guidance provided by Halozyme for the next 5 years.

The Petition was a great read, well worth skimming thru or a good read, for all HALO investors. It is amazing how anal those lawyers can get, the nit-picky details is too much, but whatever works, I guess. Can't wait for Halozymes rebuttal. If anyone runs across it, please post it....

Now if our fellow investor, bi1 didn't blow all that bad hot air about Dr. Torley competence, HALO would be at least 60 by now........just kidding...its SR fault..........

Goooo Dr. Torley...........post the MDASE Geron deal......show market the goods......

alt down 10% tonight. Think the market thinks that there’s no case against them?

Not worried about this at all. Halo is probably 6 times the size of Alt as a whole and way larger in this area than Alt. Good luck competing. This is nothing to Merck. Merck is way late
To the SC party and it’s going to cost them a fortune. Should have had an SC product at least 5 years ago.

"Merck had their chance a long time ago"...& decided to start Alteogen in South Korea instead.!
Won't have to pay HALO anything... (except the $ for their "test" sample .)

we're not referring to the language in the article which is translated from Korean. We're referring to the language in the legal document submitted to the US patent office by Merck (not alteogen), which is in original English with typos and amateur sentences. This legal document is filed in the US for the US patent office and not in Korea. It is an original English.

I agree with this. Looks like Merck is in panic mode. They had their chance a long time ago and missed the boat.

The narrative shifted from HALO being the plaintiff to MSD, so it makes it appear that Halozyme is on the defensive. Superficial stuff on a low volume week with most traders away from their desks. I'm glad the punches have been thrown, so we'll get some clarity down the road. Helen is probably exhausted from the EVO affair so she's doubtless recuperating at one of her vacation homes. I am extremely doubtful we'll have any new deals by years end.

I think it's a language translation issue, so I don't think it's of consequence.

It takes a bit of time for people to understand what is going on. Halozyme's projected EPS through 2030 is intact regardless of 1) whether halozyme wins its patent infringement lawsuit against Alteogen or 2) whether Merck can successfully apeal halo's MDASE patent.

Why? MDASE is/would be icing on the cake. The EPS projections by halo have not included any revenues from MDASE licensing or winning infringement penalties from Alteogen. MDASE was intriduced to the publice just a few weeks ago and halo did not update their 5 year projections after MDASE introduction.

Even if Halozyme doesn't get a dime from MDASE or legal case against Alteogen, it will still deliver a EPS CAGR of 25% for next 5 years.

Quite a reversal from Friday: Alteogen up 13% and Halo down 2%, Merck and Daiichi Sankyo both up, and, oddly enough, even EVO is up almost 9%!

It looks like Merck got proactive and beat Halo to the punch. Hopefully, this is not a huge problem and we have a strong case. Both Merck and DS have excellent lawyers and they don't mess around. I remember Seagen had a very long dispute with DS where many analysts thought Seagen was going to prevail; they sued and won some battles, but ultimately DS won the war.

Interesting development. And, while the translation is obviously not great, it looks like the news comes from a reliable source. Thanks for sharing. According to Wikipedia, Maeil Business Newspaper:
"It was selected as the "Premium Economic Newspaper of the Year" by CEOs in Korea for 19 consecutive years since 2005. In the economic newspaper category, the preference for Maeil Business Newspaper among CEOs of top 500 companies has steadily risen, with 51.52% in 2021, 56.88% in 2022, and 66.06% in 2023.[7]"

"Hot air"??? What are you referring to? Oh... you must be talking about your Evotec fantasies and blind cheerleading for Helen when she was clearly making a catastrophic mistake.

Peopel can go back and read your posts you know. There is a track record. 

... or maybe Merck knows their petition is baseless buy filed it anyway to buy time. With those typos and amateurish language, how else would you explain the carelessness? 

... Merck attorney seems rushed or is careless. Either way, it won't bode well for them.

Thanks for sharing. I have read about one third of it so far. It's full of typos and amateurish phrasings.

Here are a few example:

1) "clam" instead of "claim." Bottom of page 1
2) "estopped" instead of "stopped." Bottom of page 4.
3) "A set containing one molecule of each polypeptide in one

Thank you HC.....

What a treasure trove of information...

Posted the list of MDASE patents a few months ago. When HALO received yet another of the many related patents.

Would not have known 11952600 was the primary one noted in the petition.....when there are several older related patents before it.

https://www.freepatentsonline.com/11952600.html

The petition...filled with info...

https://s3-us-west-1.amazonaws.com/ptab-filings/PGR2025-00003/1

Thanks again HC, you are my Hero...showing there is more to the site then, hot air and stirring from bi1, .. ...SR....

Well... I stand corrected. Merck is getting involved. But don't be surprised if Bristol gets involved to support Balozyme. Bristol and Merck are the biggest competitors in the industry. Bristol will do what it can to maintain the SC advantage.

https://www.mk.co.kr/en/it/11175155

One of you historians look up when Merck visited an infant Halozyme, gave Halo some $ & got a "sample" (early in 2000's) to test.

Top Story
Alteogen hoping for bumper windfall from Merck & Co.’s sub-Q Keytruda
Matthew Dennis
PUBLISHED : FEBRUARY 26, 2024
Ref: Pulse, Alteogen

Alteogen revealed Merck & Co. as the mysterious pharma partner using its hyaluronidase-derived technology and announced updated deal terms that grant the US drugmaker exclusive access to develop a subcutaneous version of its anti-PD-1 therapy Keytruda (pembrolizumab). The change in the licensing deal comes with a $20-million upfront payment to Alteogen and potential milestones of up to $432 million.

Alteogen first announced in 2020 that it had partnered with an unnamed drugmaker to use its recombinant human hyaluronidase enzyme ALT-B4 non-exclusively across a number of products. The technology allows large-volume subcutaneous administration of biologics that would otherwise be administered as an intravenous injection.

At the time, Alteogen said it received an initial payment of $16 million and was eligible for milestones totalling up to nearly $3.9 billion for the products covered under the agreement. Park Soon-jae, chief executive of Alteogen, said in an interview with Maeil Business Newspaper that at least half of the Keytruda intravenous injection market is expected to transition to subcutaneous formulations, hinting at successful progress in Phase III trials.

The updated deal also allows for the partners to collaborate on additional products from Merck; Soon-jae alluded to the possibility of creating a subcutaneous version of an antibody-drug conjugate from the US drugmaker.


Convenience and biosimilar protection

Merck, along with other makers of PD-(L)1 inhibitors, including AstraZeneca, Bristol Myers Squibb and Roche, have been hastily working on subcutaneous formulations of their products, not only to improve patient convenience, but also to protect against patent expiry on the intravenous versions.

Roche’s subcutaneous version of Tecentriq (atezolizumab) is already approved in the EU and UK, while Bristol Myers Squibb has reported positive Phase III data for its subcutaneous formulation of Opdivo (nivolumab). Both products use Halozyme's Enhanze drug delivery technology.

However, Merck has fallen behind in its development efforts, with a first-generation version of subcutaneous Keytruda looking to have been deprioritised. The company has previously indicated that Phase III data for the subcutaneous version of Keytruda using ALT-B4 are due to read-out later in 2024, with the price of the product likely taking into account the availability of cheaper biosimilar intravenous versions. For related analysis, read Spotlight On: Analyst sceptical on Big Pharma’s subcutaneous PD-(L)1 strategy.

I think MERCK STARTED Alteogen.

Continuing with your line of thinking, (as you say pipe dreaming), it would be a bidding war between Merck and Bristol Myeres.

If that were the case, Halo would not have introduced the MDASE portfolio. MDASE allows competition to come to market as long as they pay license fee. It makes good Business sense.

If it was at you say and he, I wanted to stop competition in their tracks, they would not have introduced the MDASE licensing portfolio.

I disagree. Stopping a potential competitor like Alteogen in its tracks would benefit Halozyme immensely, IMHO.

Decease and desist that you referred to in your message, would not benefit Halozyme. Halo  would much rather have either a license fee or some penalty for infringement. The only real entity that would benefit from a C and desist would be brystol Myers, in which case they would be back in Halozyme with their size power and influence. Either way it won't be a giant Pharma like Merck  versus Halo.

Thank you for posting this.

-- OJ

To your point, though, it is possible that BMY might be willing to chip in to the HALO legal fund in order to slow or otherwise hamper SC Keytruda's entry into the marketplace, thus strengthening HALO's hand.

You are assuming that HALO's only recourse is to ask for a cut of the royalties. One might assume HALO could, in the alternative, gain a cease-and-desist order before SC Keytruda ever makes it to market. Thus, Merck has skin in the game, and they are not going to be passively watching from the sidelines.

Those are all valid observations. Do you think there would be anti-trust issues related to BMY?
In any event, I've been waiting for someone to purchase HALO for 16 years and so far, it's not happened for one reason or another.

I wonder if Merck would be interested in purchasing Halozyme thus locking up the portfolio of patents for the next so many years and be able to go ahead with the Keytruda sub q with the Korean company. They are looking at losing market share over the next 3 to 5 years if they can't get to market with their sub Q. I think (don't know) that Keytruda is approaching a 30 Billion dollar market. If they lost 30% of that to BMS and Optivo that is 10 billion over say 5 years. Why not get to market and protect your advantage and get paid 1 billion a year for the next 10 years for all of Halozyme's business. It really does put you in the driver's seat going forward with Keytruda and who knows what else they could put Sub Q in their portfolio. A 10 to 12 billion dollar spend now could easily pay for itself in a very short term. They just need to realize not all of the savings comes from an increase in market share but a extension of current market share for the next so many years. I also think in a pipe dream type thought process (again just dreaming not trying to sell anything) that Halozyme buying the German company could have been part of a 3 party deal where we Locked them up and Merck bought the whole enchilada and got all the great points Helen was making in her attempt to purchase. A 2 for 1 easy to sell to their board. Again just a pipe dream on my part.

Merck had no problems mivung forward because they are not at risk. It is Alteogen who has infringed Halozyme's patents. Merck has nothing to lose. They will pay alteogen and not care who alteogen has to pay for licensing or penalties.

It won't be halozyme vs. Merck. It's halozyme vs. Alteogen.

Merck will be paying Alteogen a royalty for Keytruda SC. MERCK will not care if Alteogen will have to pay Halozyme a licensing fee or penalties.

If you think Merck would get invovled then by the same rational so would BMS. BMS would back Halozyme for the same reasons you opine Merck would get involved. 

That's a thoughtful post and it will be interesting to see it play out. Merck has unlimited budget to spend on litigation compared to HALO, so that is always a consideration when going up against big pharma and Merck knows this, so they can make decisions like going ahead on SC Keytruda with a feeling of impunity. On the other side of the coin, Merck really didn't have another option if they wanted to bring SC Keytruday to market, so what choice did they have but to forge ahead knowing the patent risks. My guess is that all parties will be seeking a comfortable monetary settlement, which will ultimately cut HALO in on the royalties. If this happens it will boost HALO's stock considerably as well as drive partners back into HALO's camp. but it will take time to sort out.

I think you are probably right. We certainly need great lawyers to handle this.

It's impossible to measure the extent of it, but I think Merck's validation of Alteogen's technology has damaged Halo's reputation and may have affected their ability to sign new deals.

I am a little skeptical that Merck did not have their lawyers take a very deep and extensive look into this issue before spending a ton of money testing SC Keytruda, but if they and DS's lawyers screwed up, I would be thrilled. If Halo thinks they have a strong case and the market agrees with them, that would be fantastic.

I would think BMY's exclusivity adds another level of complexity. Do they become part of the lawsuit? Do we sue for damages? Do we try and get an injunction, which is what I imagine BMY would want, or do we try and settle for a portion of Alteogen's royalties?

Your point number 1 makes perfect sense to me.

As much as I think HALO management is truly subpar, I have a high regard for their patent attorney, who seems to be a real asset to the company. I'm watching his strategic moves with a great deal of interest.

Thanks for posting that.

The reason to wait until now is likely 2 fold;

1) see if there is it there there (i.e. see if alteogen's phase 3 was successful). No need to sue them if their phase 3 had failed

2) take time to prepare for a strong case. This is why Halo hired the chief legal officer of QUALCOMM. He is highly experienced from the litigations between QUALCOMM and Apple.

I'm grateful for your posts. They are not only informative but often also somehow about important nuggets that are missed by others on this bored and other media.

I remember you were the first one to bring to our attention that Roche is working on a high volume auto injector (likely with halo) from their slide deck.

A lawsuit against Alteogen and presumably Merck and DS would be a big deal. I had noticed that Alteogen’s stock was down 33% in the last 5 days and 15% on Friday and assumed it was a “sell the news” move after the end of the phase 3 trial of SC Keytruda, but this makes more sense. If it is true, I hope Halo has a very strong case that will lead to a quick settlement with a portion of Alteogen’s royalties to Halo, and not years of litigation. I wonder what the rationale was for waiting until now. Merck’s stock has been weak lately too but it could be unrelated.

... In fact, Alteogen is down 30% in the past 5 days

https://www.google.com/search?q=alteogen+stock+chart&ie=UTF-8&oe=UTF-8&hl=en-us&client=safari

https://cdn.abcotvs.com/dip/images/2584949_103017wlsmcdowells4.jpg

Thanks for sharing. This is big news. Alteogen's stock being down 20% on rumors of a patent law suit tells me market participants think halozyme has a high chance of prevailing. Remeber, Alteogen has other products generating earnings (unrelated to hyaluronidase) and for it to be down 20% on this news is very telling. If hyaluronidase was its only product it would have been down even more.

I expect that will happen. Kinda reminds
Me of McDowells in the moving coming to America.

https://www.msn.com/en-xl/news/other/alteogen-s-trading-volume-surges-exceeding-samsung-for-the-day/ar-AA1uy48T?ocid=socialshare

This link talks about pending law suit from Halozyme

For sure a bargain. I would also point out that alteogen stock has been down 35% in the last couple weeks. Got hammered Friday on big volume.

These graphs/comps put things in perspective for anyone investing based on fundamentals. Halozyme is trading at outsatnding bargain values. Don't take my words for it. Have a look!

Fred, why not pin these on top of this board?