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Piper Sandler downgrades HALO to Neutral, moves PT from $48-$51.
Onco, given your level of expertise, I wonder what your opinion is as to the argument that Merck was forced to go to Alteogen due to an exclusivity clause in the HALO contract with Merck's competitor. TIA. -Fritz
Thanks, though I don't remember Helen addressing this directly in previous calls. I may have overlooked it at the time. Still, my main point about forging new deals in an up-tempo way remains.
I'm not convinced there is an exclusivity barrier to making a deal with Merck, but we can't know without seeing the terms of the agreement or if Helen comments on in response to a question. Others with more expertise on this matter are welcome to chime in.
I think Helen's negotiating hand has been considerably strengthened today. If, in the next couple of quarters, she can't start reeling in a good number of multiple collaboration agreements, including with Merck, then my thesis that she is out of her league will be confirmed. We'll see what she can do. For now, I'm giving her some time to get these deals done. The first few, which have been under discussion for 18 months, should be ready to go by the end of summer. Tick Tock.
So, do you think the legal dept at Merck is not aware of the patent issues?
Thanks. That would be welcome news.
What will be the basis of the raised revenue guidance
Halozyme Announces Issuance of New European Patent for ENHANZE® Drug Delivery Platform
June 05 2024 - 4:05PM
PR Newswire (US)
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Conference Call Scheduled for Thursday, June 6 at 5:30am PT/8:30am ET
SAN DIEGO, June 5, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced the grant of European Patent No. 4269578, covering the ENHANZE® rHuPH20 product obtained from Halozyme's ENHANZE® manufacturing methods that the Company provides to its current and future licensees. The new patent is licensed under all of Halozyme's ENHANZE® licenses. It will be validated in 37 European countries and expires on March 6, 2029.
"This new European patent for ENHANZE further strengthens our robust patent estate and extends the durability of our portfolio," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are pleased to be able to maintain the original royalty rate for DARZALEX SC in Europe through March 2029 based on this new patent."
Under the terms of Halozyme's ENHANZE® license with Janssen, the newly granted patent prevents the reduction in the royalty rate on sales of DARZALEX® SC in the European countries where it is validated until the patent expires. The new patent is not expected to have any impact to royalties under other ENHANZE® licenses with an issued or pending collaboration patent, as current royalty rates for these licenses are already expected to extend beyond expiration of the new patent.
Webcast and Conference Call
Halozyme will discuss the new European patent and provide an update to its 2024 financial guidance and 5-year financial outlook on a conference call tomorrow, Thursday, June 6 at 5:30am PT/8:30am ET. The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the completion of the call. To access the webcast and presentation, please visit ir.halozyme.com.
The call may also be accessed with the dial-in information below:
Participant Toll-Free Number: 888-632-3384
Participant Direct/International Number: 785-424-1794
Conference ID: HALO0624
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.
Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility.
VKTX - One thing that came to mind today was the possibility that management's reticence is based on active talks with said large pharma. Just a notion, but it's certainly possible.
I was surprised by the selloff today, on large volume too. What did you think of the readout? It seems a little implausible to me that the selloff was simply because management was holding things close to the vest.
Do you know how many years have gone by since Dear Helen struck a major partnership deal? Have any idea how many deals she has done during her whole entire tenure with Halozyme? Go ahead, look it up. I'll wait......
Viking Therapeutics Announces Positive 52-Week Histologic Data from Phase 2b VOYAGE Study of VK2809 in Patients with Biopsy-Confirmed Non-Alcoholic Steatohepatitis (NASH)
https://ih.advfn.com/stock-market/NASDAQ/viking-therapeutics-VKTX/stock-news/93979546/form-8-k-current-report
Up to 75% of Patients Treated with VK2809 Achieved NASH Resolution with No Worsening of Fibrosis as Compared to 29% for Placebo (p=0.0001)
Up to 57% of VK2809-Treated Patients Achieved ≥1-Stage Improvement in Fibrosis with No Worsening of NASH as Compared to 34% for Placebo (p<0.05)
Up to 48% of VK2809-Treated Patients Achieved Both Resolution of NASH and a ≥1-Stage Improvement in Fibrosis as Compared to 20% for Placebo (p=0.01)
Adverse Events, Including GI-Related AEs, Similar Among VK2809-Treated Patients vs. Placebo at Week 52; Consistent with Prior Data Reported at Week 12
Conference Call Scheduled for 8:00 a.m. ET Today
The slide deck promulgated by Halozyme last month projects subcu launch of amivantamab in 2024-2025 on page 7. If this was a surprise to you it, that's ok; to most investors it was not.
It's also mentioned in HALO's slide deck posted here in the sticky section. It is a known known, to borrow a phrase.
It's stuck in the channel. CIPD PDUFA date isn't going to move the needle, IMHO.
Very good point, and we're not privy to those kinds of details.
I've never heard Helen use that as an excuse. So it is an open question in my mind.
You raise an interesting question, and that is: what exactly are the terms of these exclusivity agreements? Are they focused on the targeted disease? Are they rather defined by the MOA and chemistry of the drug itself? Is it focused on the drug as it is deployed vs the targeted disease only?
That makes sense. Thanks.
I'm not sure I understand what you are trying to say.
Thanks for posting this. This was previously known but the price paid by MSD is new to me. It seems Merck could have made the same deal with HALO for the same or similar cost, but for some reason Helen couldn't reel them in and they went to the Korean manufacturer of a competing enzyme. Troublesome.
Roundhill Investments offers weight loss ETF "OZEM"
https://www.roundhillinvestments.com/etf/ozem/
Fact sheet: https://www.roundhillinvestments.com/assets/pdfs/ozem_factsheet.pdf
(Caveat: I no nothing of their track record or reliability. Comments welcome)
Re, the new BMY Opdivo PDUFA date, see Dew Diligence's remarks here:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174464132
Halozyme Announces Bristol Myers Squibb Received Updated Action Date from the FDA for Subcutaneous Nivolumab Co-Formulated with ENHANZE®
https://ih.advfn.com/stock-market/NASDAQ/halozyme-therapeutics-HALO/stock-news/93896315/halozyme-announces-bristol-myers-squibb-received-u
(Note: The original PDUFA Date was Feb. 2025.)
Not sure what is meant by "major overhang for VKTX lifted here".
RHBBY - I wonder if the weight loss is due in part to factors related to tolerability, i.e. stomach upset and diarrhea?
Right, it only went to $33.15, so I was a whopping $3.16 off target.
My thoughts exactly. I've come to take her comments as worthless or worse, misleading.
Using leverage to make an acquisition makes sense if the acquired company is going to be a profit center, but they aren't giving those kinds of companies away. Also, the list of acquisition candidates is necessarily small because she has frittered away billions in cash on the buyback, thus the limiting potential add-ons to smallish operations.
Then, there is her judgment which is in question, as the Antares purchase is proving to be rather underwhelming.
So, is it a good strategy?
What do you think?
Also, what is your opinion about her comments on the risk of growing competition?
Does this mean that they are no longer "the leading platform for cell programming and biosecurity"?
IBD is like Zack's, in that I believe most of their content is produced by robots.
Thanks for sharing. I take issue with their term "breakout", which may indeed happen, but is used prematurely. A look at an 18 month chart will show the spring 2023 fall off the cliff (but not a patent cliff! LOL!) and then a series of 3 well defined attempts to breach $45. Each of those attempts was turned back and we fell back into the $30s each time. We're still in that deeply entrenched channel but this is the 4th attempt to rise above it. That's not a breakout in my opinion but here's hoping. What might happen is a modest one (let's say to $45.50 or similar), but even money is on another pullback. I'm assuming the latter and I believe that this will not change unless and until Helen brings forth. Stay tuned.
Was it just one of their technical analyses or did they do a deep dive into the business? I'm assuming the former; but it might drum up some retail interest even so.
Needham analyst Serge Belanger maintains BUY rating, lowers PT $18-$12
Chart wise, RSI is entering overbought territory and volume is low. This does not bode well for my hopes for a healthy breakout. My earlier opinion, that the current rangebound levels will persist absent any substantive new deals, appears to have been the more correct one.
This is a forum for the exchange of information and opinions. If one is so easily upset by a differing opinion, they are free to seek succor wherever they might find it. Mine was just one suggestion. A nearby university might also be an option in which to find a safe space.
Lighten up, Francis. It's a conversation. If all you want is laudatory comments, call your mom.
Thanks for posting. The patent was issued a year ago and there is no indication in the slide deck that GERN is moving forward with a subcu version of imetelstat in the clinic. I wouldn't get too excited about this until it becomes clear that they will, and if they do, will they turn to a competitor's enzyme instead?