Halozyme Therapeutics Incorporated (HALO) Options

Thanks, good insight....

Will see how it plays out...Geron has their Evercore presentation early tomorrow....will listen in....maybe learn something....

... correction due to obviousness. Geron did not show new unexpected findings (eg lower side effects, better efficacy, etc.) in trials.

All of halozyme's parterns who have received co-formulation patents with Enhanze, showed a new (non-obvious) finding in their trials when then combined their theraoutic with enhanze. Examples: lower side effect profile, improved efficacy, etc. 

It seems that Geron applied for the patent without ahowing a non-obvious advantage. It also seems that they haven't done much clinical trials with rhuph20. 

It also seems like they were trying to get this coformulation patent with generic hyaluronidase independent of halozyme. Well, let this be a lesson to them and others.

As far as we know Geron does not have an ENHANZE or MDASE agreement with halozyme. Reading the rejection rulling from patent office, it seems like Geron tried to get a patent for its product + generic hyaluronidase independent of halozyme and was blocked. 

When you read the document, anywhere it mentions "Frost," it's a reference to halozyme's patent. Patent office rejected Geron, because it was in violation of halozyme's patent.

This is certainly good news for halo because, Geron will now have to work use ENHANZE or MDASE if they want to convert this IV theraputic to subcutaneous.

Not sure why you consider it good news.....

It certainly delays any potential deal and product with Geron....IMO......

Hopefully it isn't a indication of the difficulties of acquiring a MDASE patent....cause it clearly was MDASE related......

Let's hope HALO has something encouraging to say tomorrow. Could use something positive instead of the same old rehash blah blah blah.......

It's possible that this negative ruling might also be applied to Halozyme partnerships.

Thanks for sharing. Good news for halo :)

Anyone follow the Geron patent posted in an earlier bread crumb post.......

Looks like after all of the work rewriting the claims, it got another "Final rejection," on 11/25......wonder what the next move will be.....The rejection will certainly be discussed at the two up coming HALO presentations.....NOT........Anyhow the 88 page rejection letter is worth a read....as was the MSD petition, which i assume everyone read.............

Goooo HALO.....back to 60 and beyond.......SR......

https://patentcenter.uspto.gov/applications/17376517/ifw/docs?application=

... correctio 8-year EPS

forward guidance for Earnings Per Share (from Oct earnings call):

2024 Guidance: $4.00 - $4.20
2025 Guidance: $4.45 - $4.85
2026 Guidance: $5.70 - $6.20
2027 Guidance: $7.15 - $7.75
2028 Guidance: $7.50 - $8.10

If you assume zero growth (absurd, I know) in EPS for 2029, 2030 and 2031 and add all these EPS's up, you will get to a 6-year EPS range of $51.36-$55.4

Cash is $5/share and debt is $8/share. If you add the cash/share and subtract the debt, you get to a range of $48.36-$52.4.

This calculation assumes no new Enhanze deals, no HVAI, no MDASE licensing income and losing the litigation against Alteogen. This will also assume that all future hyaluronidase deals will go to Alteogen and zero deals to Halo (also absurd).

At its current share price, halo is trading under the value of its next 6 years of earnings plus cash minus debt.  It is an excellent buy here, regardless of the noise around patent fight with Alteogen/Merck.

Don't be surprised if private equity buys halo.

Sources:

https://s28.q4cdn.com/284259014/files/doc_financials/2024/q3/HALO-3Q24-Earnings-Deck-FINAL.pdf


https://finviz.com/quote.ashx?t=HALO&p=d

Well if competition is her thing, Dr Torley has a lot to be thankful for.

Funny how not to long along the discussion was. "There is no competition," to finally realizing there is competition and there needs to be some legal action....

Time has pretty much ran out....

Alteogen and Merck....

https://medcitynews.com/2024/11/merck-keytruda-subcutaneous-injection-cancer-pembrolizumab-biosimilar-alteogen-mrk/

Celltrion.....

https://www.biospectator.com/news/view/23714

Hounslab......

https://koreajoongangdaily.joins.com/2023/02/21/business/industry/korea-huons-huons-lab/20230221175541928.html

All biting at the bait..........

And they wonder why Dr. Torley wanted Evotec......

Gooo HALOooo, give it your best........

Happy Thanksgiving to all!

Well said, Howee, best wishes for a happy thanksgiving filled with warm family gatherings and reunions with good friends, the only things that really matter.

Happy Thanksgiving Helen, too!

Same from me. I know there’s a lot of arguing back and forth but to me it’s all for fun. We all want success for Halo.

Happy Thanksgiving ! All you posters!

.... 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.