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Roche subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS
04/17/2024 | Briefing.com
RHHBY
Roche announced today data from the Phase Ill
OCARINA Il study (S31.006) of OCREVUS (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous (SC) injection. Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation. Treatment with OCREVUS SC led to rapid and sustained B-cell depletion in the blood. The data will be presented as an oral presentation at the 76th American Academy of Neurology (AAN) Annual Meeting taking place April 13-18 in Denver and has been recognised as an abstract of distinction by the AAN scientific committee. Updated, longer-term results showed that OCREVUS SC injection (920 mg; n=236; both treatment arms [OCR SC/SC and OCR IV/SC]) resulted in near-complete suppression of relapse activity (97.2% had no relapse during the treatment phase) and MRI up to 48 weeks with an ARR of 0.04, and most patients having no T1 gadolinium-enhancing (T1 Gd+) lesions and no new/enlarging T2 lesions. These lesion types are markers of active inflammation and burden of disease, respectively.
What clues have seen you for Selatogrel being used with rhuph20?
What clues have seen for Selatogrel being used with rhuph20 ?
Price/Earnings Ratios:
2024 Estimates
11.63
2025 Estimates
9.31
2026 Estimates
6.83
Forecast 12 Month Forward PEG Ratio 0.47
https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios
From Akos on Yahoo:
“J&J reports Q1 sales of darzalex , $2.692 billion up 18.9 percent year over year.
24q1. 2.692
23q4. 2.55
23q3. 2.49
23q2 2.43
23q1. 2.26”
The top 5 science research-related stocks in 2024, as of the latest data available, are:
Biomarin Pharmaceuticals Inc. (BMRN) - 43.0% 5-Year Average Annual EPS Forecast
Halozyme Therapeutics, Inc. (HALO) - 25.0% 5-Year Average Annual EPS Forecast
Incyte Corporation (INCY) - 22.5% 5-Year Average Annual EPS Forecast
Genmab AS (GMAB) - 19.7% 5-Year Average Annual EPS Forecast
Exelixis, Inc. (EXEL) - 19.0% 5-Year Average Annual EPS Forecast
These stocks were chosen based on their forecasted earnings growth over the next five years, with a focus on those expected to grow EPS by an average of at least 9.5% per year over the next five years.
Again, please provide the date for your post on this board when halozyme was in the low 30’s and you (as you claimed) posted about buying halozyme.
Yeah, right! We all believe you. Would you please share to the date of your post when you indicated you were buying some in “low 30’s”? BTW, a retrospective post of saying you bought in 30’s when the stock was already hire would not count.
My prediction of triple digits was incorrect. I own it. It was predicated on three new deals, one of which was supposed to be a major innovation with high-volume auto injector.
This is exactly why I am critical of Halo’s management. They did not deliver on what they projected. You don’t seem to be able to process that an investor can be simultaneously expecting more of a management and yet think that the underlying technology is of a greater value than the market gives it. This is exactly why halo was cheap in low 30’s. The permabears were predicting it was headed to 20’s. It did not.
My point in many of my posts has been that even without new deals, halo was and is cheap. It won’t go to 100’s without new deals, but it can easily reach 50’s and 60’s with existing programs based on it’s PEG , PE ratios, growing profit margin and EBITA.
Last time there was a bunch of doom and gloom posts in agreement of each other by our three perma-bears on this board, we rallied from 30’s to 40’s. Prior to 2023, we saw that same phenomenon with the 2 perma-bears. Each time the numbers of their negative posts in agreement with one another went up, we rallied from single digits to teens and teens to 20’s and so on. Let’s welcome this overtly bearish sentiment, it seems to signal a new rally in halo.
“Evil”?!!! Who said anything about management being “evil”?!!!
I’m sorry you regularly resort to hyperbole and see everything at such black and white extremes. This kind of emotional thinking is not how wealth is created.
It is perfectly reasonable to ask for more from management when they don’t deliver on certain promises (e.g. 3 deals for 2023). It is also reasonable to lean on them for selling (as opposed to buying some) shares when many including the management opine that the stock is undervalued.
Despite these shortcomings, a reasonable investor can also simultaneously appreciate the underlying successful technology that has made Halozyme highly profitable and a EBITA growth machine.
Just because they failed on a some fronts, it does not make them “evil” or “self-destructive.” It just means they can do better. Even the best C-suites make some mistakes at times. Best case scenario they learn from their mistakes and worst case scenario, investor can push (or at least express a need) for a change in leadership (I for one would be happy with changes). However, none of this makes the management “evil” or the underlying successful technology “un-investable” as you claim.
If you thought this way, you would have missed the recent 30% run from low $30’s to $40 and the previous runs from single digits to all time highs. Some of us were able to see the value of Enhanze despite the management failures in 2023 and loaded up even more in the low 30’s. I wrote on this board that Halozyme is a cash generating machine despite the management (not because of it) and still believe this.
Halozyme will continue to grow EBITA and is undervalued based on the already-approved Enhanze products. The stock will be perform quite well even without new deals. However, some of us (including me) would like to see even more with new deals, insider buys and better communication.
Fantastic tweet from today:
“I ran a screener of
ROIC 3yr Average >20%
FCF margin 3yr Average >15%
Revenue Growth >25%
The top 4 Results were
1) Nvidia $NVDA
(46% / 28% / 125%)
2) Booking Holdings $BKNG
(28% / 28% / 25%)
3)Arista Networks $ANET
(51% / 25% / 33%)
4)Halozyme $HALO
(42% / 47% / 25%)”
I could not agree more.
Apparently, halozyme has hired a new PR firm to help them. But we have an IR problem as well. She does not respond to any form of communication.
am I dreaming? Are my eyes deceiving me? Did LaBarre just convert some options and held onto the shares without selling a single one? This is welcomed news. https://d18rn0p25nwr6d.cloudfront.net/CIK-0001159036/465f2965-ed25-4e96-9042-6b62a53e45e3.pdf
what’s going on with Halozyme’s IR? emails unanswered, voice messages unreturned, requests to speak with executives ignored, multiple new trials, and no PR. The investors deserve better.
Pace of new trials with Enhanze seems to be picking back up. 3 new ones just in the past week. Things were quiet for a while.
Another brand new study with Enhanze (first posted on 3/15/24).
Phase 1 GSK/Viiv trial + Enhanze on a brand new antiviral:
https://classic.clinicaltrials.gov/ct2/show/NCT06310551?term=Rhuph20&draw=4&rank=122
According to Table 2, the 10ml HVAI’s are in “development.”
Helen said that Halo’s 10ml HVAI is the first ever and no one else has done successfully in humans.
It seems that halo is ahead of
Much is happening in the AI (autoinjector) world and halozyme is far ahead of everyone else with it’s exquisite HVAI. Once we have a HVAI deal, there will be a buzz that will take share price to all time new highs.
Also you can do a word search in their most recent 8k and 10k filings. There is no mention of TED with Efgartigimod (Argenx)
I think you are incorrect. I don’t ever remember, Halozyme having 2 deals with 2 different partners (Horizon and Argenx) for the same indication (Thyroid Eye Disease).
Also there never a phase 1 or phase 2 study of Rhuph20 (or ph20, or hyaulonidase) combined with Efgartigimod (from argenx) in clinicaltrials.gov
There are 151 trials with rhuph20 (including all the old trials whether completed or not)
Go check it out yourself.
… we now are far more advanced in this indication than we ever were with Horizon.
…They went straight to phase 3 for a new indication with Enhaze. This is what Helen was talking about when she said regulator no longer need non-inferiority data and all they need is PK study.
Expect big PR about this.
2 Brand new studies of Efgartigimod PH20 SC in Adults With Thyroid Eye Disease posted on clinical trials gov for the first time today. One is with a pre-filled syringe.
This is a new indication for Enhanze and Argenx that was not previously disclosed by Halozyme.
https://classic.clinicaltrials.gov/ct2/show/NCT06307613?term=Rhuph20&draw=3&rank=107
https://classic.clinicaltrials.gov/ct2/show/NCT06307626?term=Rhuph20&draw=3&rank=106
From Helen’s talk yesterday:
1) The 20-30% ANNUAL growth in EBITA is based on already approved products (wave 1-3).
Wave 4 and anything beyond will be icing on the cake.
2) EBITA profit margin is expected to GROW to over 70% by 2028. profit margin is already impressive but for it to grow is absolutely terrific.
Is intramuscular route of admin the next large market ready for disruption by Enhanze? It would be great if Helen comments on this article and its potential for Halozyme tomorrow. This is an IM injectable for a psych indication with huge TAM. https://www.biorxiv.org/content/biorxiv/early/2024/03/06/2024.03.03.583160.full.pdf
From Artisan (the largest, non-index investor in Halozyme) December 2023 letter:
“Halozyme provides a unique technology platform that allows for the conversion of biologics and small molecule drugs administered intravenously into a subcutaneous formulation. The company generates predictable and durable royalties from licensing its technology to pharmaceutical companies looking to optimize their therapies. Underperformance was partially related to Argenx, along with headwinds due to Inflation Reduction Act-related US drug price regulation and a lack of new partnership announcements. Regarding Argenx, Halozyme scored an important long-term growth opportunity in Q3 when the FDA approved Argenx's subcutaneous version of Vyvgart, called Vyvgart Hytrulo. However, its shares declined following Vyvgart's two failed indications in Q4 (discussed earlier). Despite this setback, we continue to expect expanding commercial opportunities for Vyvgart and Vyvgart Hytrulo, along with a solid pipeline of other new products in the coming years. Halozyme recently released updated guidance and forecasted 2023 royalty revenue of $445 million-$450 million and $1 billion in royalty revenue by 2027.
While Halozyme was the top detractor in 2023, it was the top contributor in 2022, has been one of our most successful campaigns since its early 2017 purchase and remains the second-largest position in our portfolio.
Any time we experience noticeable underperformance in an economic sector, we work hard to retest our assumptions and challenge ourselves to be open-minded to the possibility that our investment thesis is off target. In some cases, this has led us to reduce positions where new evidence suggested the profit cycle dynamics had deteriorated. But, in most cases, we remain very optimistic about the mid- and long-term profit growth potential of our key health care holdings. For example, we opportunistically added to Exact Sciences after an earnings-related selloff in Q4, maintained our position in Ascendis following the FDA's request for additional manufacturing data in Q2 and added to our position in Repligen in Q3 on the belief that the COVID-19 vaccine overhang would fade. These actions began to bear fruit as the year went on, and we believe our patience with these stocks, along with Halozyme, Shockwave, Argenx and iRhythm, leave our portfolio's health care exposure well positioned entering 2024.
String work. Thanks for sharing
… and she did mention a psych indication a few times early in 2023. Your find is certainly plausible.
Great find. It’s a treatment for schizophrenia and schizoaffective disorder.
Here is the current approved dosing regimen:
234 mg IM x1 on day 1, then 156 mg IM x1 on day 8, then 117 mg IM qmo;
IM is painful and patient will much rather switch to SC. This is monthly IM injection which is likely required for years and decades with a very large TAM.
… and one more thing. Halozyme doesn’t have only one product. It has a platform with many proven partnered product combos.
Saying halo only has one product is akin to saying NVIDIA only sells chips. True but irrelevant.
Yes you ate correct. That is my assertion.
I rather be invested in something that is undervalued without any new catalysts rather than invest is something that is overvalued based on the hope of future catalysts.
The new catalysts will be icing on the cake but I won’t need them to have an ROI. I said this when halozyme was in 30’s, 20’s, teens and even in single digits and took the other side. We all know how it’s panned out. According to you this strategy has been unwise since Halozyme was trading at $8.
Halozyme is still severely undervalued at a PEG of 0.5 and 2014 PE OF 12.
You are incorrect in stating: “royalties get cut in half on about 45% of total sales.”
This step down/cut you mentioned only applies to Darzelex SC (i.e. Faspro) royalties. It is not the case for any of the other Enhanze products (Fesgo, Vyvgart, etc.)
It also does not apply to product sales. Remember that in addition to royalties, Halozyme sells Enhanze itself.
And, it also does not apply to milestone payments.
The step down in royalty rate in a single product outside US is more than offset by continued growth in all of the other royalties, sales, milestones, etc. combined.
This is why Halozyme gave a 5 year projection in Jan and reiterated in Feb of 20-30% EBITA CAGR growth. 20-30% ANNUAL growth in EBITA between now and 2028 is pretty well understood by now.
This kind of misinformation has gotten old and has lost its effectiveness. It’s probably why share price has gone up about 30% without any new deals or positive news since January when Halozyme dispelled the patent cliff misinformation. Time to find something else.
That’s incredible. How soon do you think we will see a new partnership?
From Helen today: for IV to SC conversion (when IV is already approved), the regulators are longer asking for non-inferiority studies. All regulators want are PK studies. This, she says will significantly shorten approval times.
You are correct
Don’t confuse PFS with AI
Agreed. We need better IR.
Halozyme (HALO) has received a new Buy rating, initiated by TD Cowen analyst, Brendan Smith.
Brendan Smith has given his Buy rating due to a combination of factors surrounding Halozyme’s impressive ENHANZE technology and its extensive partnership portfolio. The technology is considered a gold standard in the subcutaneous drug development space. Its success is evident in the firm growth of commercial drugs, with expectations of doubling revenues by the fiscal year 2028. Smith highlights the underappreciated pipeline that should compensate for any potential decline in the legacy franchise, supporting an Outperform rating with a $54 price target.
Furthermore, Smith’s outlook is buoyed by Halozyme’s substantial royalty growth, driven by the current ENHANZE drugs, and he anticipates continued double-digit growth in revenue and profits for the next few years. The company’s strategic partnerships with industry giants and the potential for over thirty drugs through these collaborations reinforce the positive trajectory. Key upcoming catalysts for Halozyme seem largely derisked, with the expectation of three new launches by the end of 2025, further solidifying the company’s growth and justifying the Buy recommendation.
https://www.tipranks.com/news/blurbs/buy-rating-affirmed-for-halozyme-on-strong-enhanze-technology-prospects-and-robust-partnership-pipeline#google_vignette