Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Going to close that gap this week.
-Fritz
LOL. I found your ZBIO discovery very interesting.
-F
Xena, you are way ahead of me in technical knowledge. I have simply learned that, with HALO, after a big run-up there is always a substantial pull back on lower volume which, as Rod has pointed out, is often aimed at taking out stops and flushing out panicky sellers. As for a "need", well, that isn't necessarily true, but if the stock run-up on high volume pauses and if there is a bit of disconcerting news or even just a lull in news, then you can be pretty sure that it will happen. Just part of the landscape here. The fundamentals are the main thing and the sentiment, on this board at least, is pretty confident.
Good luck!
-Fritz
Thanks, Gary. I was hoping to hear your point of view here. Nice to check in with the facts once in a while.
Good luck!
-Fritz
It is ambiguous but I'm assuming $100 million cash on hand at end of 2017.
I haven't had time to listen to Helen yet.
-Fritz
HALOZYME PROVIDES PROGRAM UPDATES, 2017 FINANCIAL GUIDANCE AT 35 TH ANNUAL
JP MORGAN HEALTHCARE CONFERENCE
SAN DIEGO, Jan. 9, 2017 — Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel
oncology and drug-delivery therapies, today provided program updates and its annual financial guidance at the 35 th annual JP
Morgan Healthcare Conference.
“We enter the year with strongly supportive data from our HALO 202 study in metastatic pancreatic cancer patients and
momentum in our HALO 301 global registration trial for our investigational new drug PEGPH20 in a similar, targeted HA-High
patient population,” said Dr. Helen Torley, president and chief executive officer. “In 2017 we expect to make continued progress
demonstrating the pan-tumor potential of PEGPH20, as we also focus on near-term catalysts in our revenue-generating
ENHANZE™ platform, including the potential approval of rituximab SC in the U.S. and progressing other partnered programs in
the clinic.”
In addition to HALO 301, the company has ongoing studies of PEGPH20 in combination with Merck’s KEYTRUDA ®
(pembrolizumab) in gastric and non-small-cell lung cancer patients and in collaboration with Eisai in combination with HALAVEN
® (eribulin) in breast cancer patients. Two new studies exploring four tumor types are planned to start in 2017 as part of a
recently announced clinical collaboration with Genentech. Under the collaboration, Genentech will evaluate PEGPH20 in
combination with its anti-PDL1 TECENTRIQ ® (atezolizumab) in pancreas and gastric cancer and Halozyme will evaluate the
same combination in gallbladder cancer and cholangiocarcinoma. Halozyme has also been included in an innovative, patientcentered
clinical trial planned for initiation in 2017 called Precision Promise, led by the Pancreatic Cancer Action Network.
In the Halozyme ENHANZE™ platform business, the company announced in November 2016 that the U.S. Food and Drug
Administration (FDA) has accepted Genentech’s Biologics License Application for a subcutaneous formulation of rituximab in
multiple blood cancer indications with an action date in June. This is a co-formulation with Halozyme's proprietary recombinant
human
Page 1
hyaluronidase enzyme (ENHANZE platform), approved and marketed under the MabThera ® SC brand in countries outside the
U.S.
In addition, Halozyme plans in 2017 to support ongoing development of subcutaneous formulations for Roche’s PERJETA ® and
Janssen’s DARZALEX ® , work with existing ENHANZE platform partners to advance development of additional licensed targets,
and seek to sign new global licensing and collaboration agreements.
The company also provided financial guidance for 2017 of: • Revenue of $115 million to $130 million , excluding revenue from any new ENHANZE global collaboration and
licensing agreements that may be signed during the year. The company expects to report $20 million in 2016 revenue for
reimbursed partner R&D expenses that will not recur in 2017; • Operating Expenses of $240 million to $250 million , supporting the ongoing Phase 3 study in metastatic pancreatic
cancer patients and the continued execution of clinical programs to study the pan-tumor potential of PEGPH20;
• Year-end cash balance of $100 million to $110 million .
Dr. Torley will present at 3 p.m. PST, Jan. 9 at the conference. Her presentation will be webcast through the “Investors” section
of www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast,
please log on approximately fifteen minutes prior to the presentation to register and download any necessary audio software.
Rod, do you have a back of the envelope calculation on when we might expect the Phase III interim look?
-Fritz
Helen goes on at 6PM eastern tomorrow (Monday). Should be interesting if they include a Q & A.
-Fritz
Testing the gap on low volume would not be worrisome IMHO. However, of course, a high volume pullback would be cause for concern.
What are your thoughts on my query about the definition of "trending"?
-Fritz
Excellent post, FOTD. Your summary is crystal clear. AF is trying hard to take the wind out of the sails but about 25 million shares have changed hands in the last two days and the price has risen substantially as well. The whales and other movers and shakers are not the ones AF is affecting. His reach is limited to the retail buyers and they are really of no consequence here. The big boys are buying and that shows their confidence in the data. The SP might, as you say, start to drop again, but that will happen only when the volume recedes back to low levels and can the SP can then be toyed with, as we have seen over and over again. At that point the latest gap might be a buying target to watch for.
My only reservation to your comments is in the topic of trending OS.
Is "trending" in this context a legal term of art with a specific definition which can be found in federal statutes or in the Code of Federal Regulations? Or is this, as I suspect, a term with no real definition which can therefore be shrunken or broadened according to the convenience and intent of the user?
If it is the latter, then IMHO the odds of a positive and early move by the FDA are greatly enhanced.
Thanks again for your considered input.
Good luck!
-Fritz
These numbers are going to change everything. The implications are not just limited to a filing with the FDA for this one indication. Big Pharma has been waiting for this info for a long time. They know what it means and won't be swayed by the noise and FUD out there on social media, etc. If HALO wants to be absorbed by a bigger outfit their price just went up and they will get it. If, instead, they want more partnership deals, they will henceforth start rolling in, and at more favorable terms. We have officially turned a corner and now the payoff has just begun.
Stay tuned.
-Fritz
IMHO, the OS is "trending positive" while the PFS goal was clearly and unambiguously met. Helen has said more than once that these are the conditions under which they might seek early approval.
They also said in today's call that they have already shared these data with the Feds. Lastly, Helen sounded positively giddy this morning, though that might have been due to the fact that it was 5am in San Francisco. LOL.
Good luck!
-Frita
Now that the shorts have covered (>16million shares traded today) they'll let it run tomorrow and the next few days.
Good luck!
-Fritz
OS data is going to get us over the line with the FDA. Expect more news soon.
Congrats to all longs.
-Fritz
He's got to sell them first.
-Fritz
They will be drawing from a broader but, perhaps, sicker population.
-F
What a rag. I can't believe it remains in print after all these years.
-Fritz
Rod, couldn't put my finger on the protocol changes. Were they significant?
Thanks,
-Fritz
Wow. We can beat that.
Thanks for posting that.
Good luck!
-Fritz
I haven't researched it but have my suspicions. LOL
Good stuff. Along the same lines, I did notice that Helen rather abruptly ended the CC when the next questioner didn't come to the phone right away. She sounded very anxious to terminate the event and did so without her usual grace and style.
Thanks!
-Fritz
What is the cource of your information regarding a "quiet period"?
Thanks!
-Fritz
So that's the SWOG study. I knew it wasn't referring to HALO-202 which is, of course using Nab-Paclitaxel Plus Gemcitabine.
Good hints abound.
Good luck!
-Fritz
Rodman and Renshaw initiate with buy rating
PT: $15 bucks a share. Geez.
Good luck!
-Fritz
Helen has stated on every occasion, however, that "HALO remains blinded as to the results".
-Fritz
Correct.
Rest assured that if DPDW starts making money from an uptick in the sector, none of it will reach investors before it is skimmed by the rapacious management. Beware. There is a VERY long track record here.
Good luck!
-Fritz
Gap closed.
Good luck!
-Fritz
According to my chart it has to touch 11.50, so not quite yet.
-Fritz
Looks like that gap will fill as anticipated.
-Fritz
Thanks! I was only aware of it's history as a potentila cancer therapy from the book "A Commotion in the Blood" and in GNVC's failed Teneferade trials.
-Fritz
Forgive my ignorance, what does TNF have to do with auto immune diseases like rheumatoid arthritis and Crohn's Disease?
-Fritz
Then, of course, we have Fibonacci to think about as well. LOL
-Fritz
I can't say if we need to fill that gap but it usually happens in my experience with HALO. The shorts pile on like wood ticks after a big move has settled down to routine days. All that being said, I am no expert as my track record here so amply demonstrates. Onward and upward would be fine with me!
Good luck!
-Fritz
Maybe we can still save a few bucks by moving right into Genentech's offices. LOL
I guess it would be logical to assume that Halozyme is a part of the "imCORE Network" (TM)(LOL).
-Fritz
It gapped up from ~$11.50 a couple of days ago.
-Fritz
Volume is tailing off and there is a gap to fill so I'd expect it to cool off soon, at least for a little bit.
-Fritz
HALO does have a outsourcing agreement with another company (who's name I have forgotten) to manufacture some or all of their original enzyme rHuPH20, so I'm assuming that is the product you are inquiring about.
-Fritz