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.
This unfortunately eliminates what was our best chance to beat guidance and exceed expectations for 2023. And it creates more uncertainty.
SC efgartigimod PDUFA date pushed back to June 20, 2023
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/90072505/argenx-receives-notification-of-pdufa-date-extensi
What was the news? I haven't seen it. TIA!
Move today on positive roche Tecentriq news.
Move today on positive roche Tecentriq news.
That metric means it’s time to bolt! BlackRock CEO just another globalist like Klaus Schwab. The moment Halo goes woke there will be a mass exit for the doors…it’s been a great ride but I’m sorry to see they let the Marxists in the henhouse!
I think the strong action today is probably due to JNJ failing a late stage HIV vaccine trial. According to Halo's website, 4 out of 11 Enhanze products in phase 1 trials are HIV vaccines or treatments.
https://finance.yahoo.com/news/1-j-j-discontinue-hiv-134905460.html
So it appears. That, by itself, is not enough to spur enthusiasm, but the drumbeat of sells is downright disheartening, and confusing in light of the rosy projections. Lucky thing that there is a buyback program in place.
Unfortunately, there hasn't been any insider buying since 2020 and that was @$14.
Thanks for that Roche tidbit. Of course, HALO's crack PR team has it at phase 1.
https://halozyme.com/drug-delivery-technologies/enhanze/#pipeline_group_1
"Probably wanted to buy his girlfriend a nice gift for Xmas."
Yes, and hopefully he only has one girlfriend.
At the JPM conference, Roche's CFO said Ocrevus SC could potentially open up a further 15-20% market opportunity with the potential for home administration. Ocrevus is now Roche's largest product. Phase 3 study results are expected in Q4 '23.
Yes, that was the one I was referencing that raised eyebrows, but seems like he was alone in that regard. Probably wanted to buy his girlfriend a nice gift for Xmas.
OK, tax obligations, programmed, and so on… Again, the investor pays his money and takes his pick. I really wasn’t expecting a news release stating that a sale took place because it just seemed opportune.
I do see a buy on the list.
https://www.insiderscreener.com/en/company/halozyme-therapeutics-inc
Matthew Posard's sale in December especially was pretty significant because it was not planned and I believe he sold about a quarter of his holdings.
No, you're reading it correctly, however the sales were mostly to cover tax obligations, and these are stated in a little footnote right in the Form 4. There were one or two farily significant sales by a director that were more of the type to raise eyebrows, but not enough to establish a trend, in my opinion at least.
All the best,
-Fritz
With a few exceptions, management has generally held on to their HALO stock, so I don't agree that that is an issue here.
Your point as to the wording of the HALO news release well taken. Investors will have to make up their own minds. As an aside, for example, it is not uncommon for individuals to gracefully resign following persuasive guidance or prior agreement.
As to what will be the situation 4-5 years from now, and forecasting stock prices based on that, let us just say that paper is patient, it accepts anything. The facts are that, despite cash compensation which is not miserly, and independent wealth in some cases, management shows less patience or conviction and, generally, cashes in the stock grants as soon as they are received. Further, if the Enhanze business is such a sure fire thing, I don‘t understand the cash purchase of a less than thriving and no longer patent protected auto injector business. I wrote at the time that it makes sense under less certain “Enhanze alone” guaranteed circumstances and then only just and depending on further, patentable, product development.
I would agree that the future is more nebulous than the $ 7 or 8 earnings per share forecast would lead the reader to believe.
Helen was not on her game at this presentation. The one positive I took out of it was the three new deals. I'm not her biggest fan, but when she says things like that they usually become reality. The only question is how large the deals will be or, if moderate in scale, will they represent a new and impactful class of collaboration. Stay tuned.
In any case, I don't think the drop was caused by this announcement. The market reacted immediately to the financial guidance and outlook. Also, my guess is that the meeting at the JPM conference did not help. There was no exciting news and Helen did not provide any clarity on the issue of the potential stepped down royalty rates in 2024 and 2027. In fact, one could argue that she clouded the issue even more. Towards the very end of the call, the JPM analyst asked if at some point we will be able to tell what products have a stepped down royalty rate ("Will we be able to parse it out?") and Helen seemed to hesitate, then said, "No, I don't think so."
So, we are left to guess how many products and which ones will have a stepped down royalty rate starting from 2024. Helen basically said some products will and some will not and you have to trust there will be continued growth because they have enough products in the pipeline.
What do you mean by "The conversion was done to suit the lender."? Halo's PR says "Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that it has elected to redeem....In accordance with Section 5.03(A) of the Indenture, Halozyme has elected to settle any conversions..."
This is what I care about:
“SVB Leerink Sets Halozyme Therapeutics
FY2027 Earnings Estimates at $7.51 EPS.”
It means that Halozyme’s earnings will grow 3 folds in the next 4 years. If you put a conservative PE ratio of 20 (very conservative for a fast growing company like Halo), you will have a $140 share price for 2027.
This is why all the dips are a blessing. Fundamentals dictate that over the next 4 years, we are headed to $140. I have and will load more every time the train has a stop. Been doing it since halo was in low teens (go back and see my posts)
I doubt very much that we are looking at a choice Halozyme made. The conversion was done to suit the lender. The chorus of recommendations also. The lender liquidating the stock around these prices is a double +/-. Not bad. I would take it, in light of world economic outlook. As to Halozyme buying this stock back at these prices, it makes zero sense.
I agree with those no longer dazzled by the financial engineering.
I am not sure why they chose to do it a year and half early. Could there be some tax benefits? In any case, I agree that there probably was only a small amount of this issuance left to cash in.
I'm pretty sure there was a nominal amount of that issuance left to cash in. It was refinanced with the second convertible. They have made plenty of money using these instruments. I'm not complaining. Keep in mind that they've been buying shares way cheaper than the conversion price of rounds 2 and 3.
In your estimation, why did they chose to force the debt into equity? Is there a strategic purpose? They had been paying a very favorable interest rate (1.5% if I recall correctly).
Today's drop was a combination of three things, IMHO:
a) technical factors, which I spoke about a few times in the last few weeks,
along with the precipitating events of the
b) change in guidance
as well as
c) the dilution.
In her presentation, Helen all but promised 3 new deals this year. One Enhanze deal, one enhanze plus high volume injector, and one small volume injector deal. If she can get them done, and if they're not small potatoes, it might help regain lost momentum.
Consider yourself lucky to be able to pick up more shares at a significant dicount as I hope you did when we dipped into teens, 20’s and 30’s…. Nothing goes up in a straightline. Halozyme has some of the best derisked fundamentals in the industry. Highly profitable with continued earnings growth for many years to come offered at a low PEG and 2023 PE in the teens.
The convertible bonds is really old news. It was always known that they would have to be converted or paid back at some point. Halo’s SP was already punished for this once. It does not count against you twice. Once the market recognizes this, the stock will settle higher.
Regarding the 2023 guidance vs the market concensus, listen to the first Q&A at the end of Helen’s presention at JPM last night (it’s on Halo’s website). Helen said it’s not due to lower royalties but rather due to DELAYED milestone payments. She reitrated that the payments are only DELAYED and not lost. Total milestone payments over the next 2 years remains in line with market consensus.
Issuing shares at the conversion price of $23.79 and buying at $50, more fun with spinning wheels and financial engineering.
Meanwhile, Helen contunues to fail to deliver the goods but is good at creating these distractions....
No….,! Games? Not being played, they already HAVE BEEN played. Now, buyers need to be found for a lot of shares. Promoters at work!
Conversion price is $23.79, so I'm guessing a lot of games are being played. And perhaps halo is buying some shares.
MS and JPM also reiterated their ratings.
SVP Leerink reiterated their outperform rating with a PT of $61, but that was 4 hours before the announcement of the calling in of the convertible debt.
It’s even worse this morning. They also announced redemption of the convertible notes due in 2024.
"2023 Total Revenue Guidance of $815 to $845 Million Representing >20% Growth Over Expected 2022 Revenue
2023 Recurring Revenues from Royalties Projected to Grow by >20% to $445 to $455 Million"
20% growth is disappointing, especially in royalties.
Halo provides financial guidance and outlook. It's lower than analysts' estimates.
https://finance.yahoo.com/news/halozyme-provides-2023-financial-guidance-221500873.html
Argenx updates on SC efgartigimod
https://ih.advfn.com/stock-market/NASDAQ/argenx-ARGX/stock-news/89930889/argenx-highlights-2023-strategic-priorities-across
I think the fda approval process is too long. If you want this stock to really fly the fda let’s the process start at phase 111. Then companies will be lining up.
I think the fda approval process is too long. If you want this stock to really fly the fda let’s the process start at phase 111. Then companies will be lining up.
I think several companies are able to develop their own SC formulations (e.g., Merck, Pfizer, Amgen, and even Roche). I am not clear if they developed their own technology or work with one of Halo's competitors.
What I find even more perplexing is that halo's deals with Abbvie, Pfizer and Lilly have generated no Enhanze products and as far as I know they don't even have anything in the clinic.
On the other hand, besides Darzalex FasPro and Phesgo, we have several other blockbuster drugs in phase 3 or (SC efga) about to be approved.
Everybody knows that there are dozens, if not hundreds, of IV drugs that could be co-formulated with enhanze, yet the pace of these deals is perplexingly glacial. Any ideas why?
Ripe for Halozyme and Enhanze: FDA Approves LEQEMBI™ (lecanemab-irmb from Biogen) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
JANUARY 6, 2023
Route of administration for LEQEMBI:
“10 mg/kg administered intravenously once every two weeks”
Source: https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembitm-lecanemab-irmb-under-accelerated-approval
I agree we need more good news for the stock to go significantly higher. It could be new deals or positive news about the patent expirations, co-formulation IP and how they will impact halo's royalties. It will be interesting to see how Helen will respond to the usual questions at the JPM conference next Tuesday.
Agree about the useless computer generated stuff put out by that "research" site. Disagree about a significant bounce, at least for now.
My feeling is that we get back to the $40s and see a period of consolidation maybe in the low $50s. Another run is not imminent unless triggered by a news event.
As I mentined about a month ago, my opinion is that HALO is fullly valued at the mid $50s and I thought that the run to near $60 was overblown. I said a pullback to $55 was a near certainty and here we are. I did have my trading shares called away and I've elected to put those profits into another more promising investment. I continue to hold my core HALO shares and will constantly reassess that position as the year moves along. A market downdraft and a long stagnant period with no percieved progress could result in this stock reaching the 200 day which today is about $46. On the other hand, a good stretch of new deal announcements and we could be on our way to the next level. Time will tell.
I am not familiar with CFRA research but imho this type of analysis is useless for a company like Halo.
Given that the XBI was up over 2% and many biotechs were very strong, stock action was somewhat concerning today, and volume was pretty high. We tend to do better on risk off days, though.
I think we are right at the 50 day moving average. Hopefully, the stock bounces from here.
Just picked up a few more shares when the price dipped below $55.
FYI, the following buy/sell ratings are held on Halo by the following agencies, as of the following dates:
Schwab: "A" rating (outperform, highest rating), as of 1/4/23
Reuters: Outperform (2nd from highest rating), 12/24/22
CFRA: Hold (middle of 5 ratings), 12/30/22
FYI, CFRA graded HALO poorly on the dimension of "growth," which is one of 6 factors that go into the overall "Hold" rating. CFRA rated the company's growth prospects as "negative." The report explains that "growth" includes factors such as EPS growth and stability and cash flow growth and stability.
A chart included in the report shows the company's 1-year compound annual growth rate (CAGR) for EPS to be -47.0%, compared to 6.4% for its peer group and 7.0% for the S&P 500. I'm guessing this may have to do with some arithmetic calculations that got thrown off by the Antares acquisition. There seems to be some wild fluctuations, since the corresponding figures for the 3-year %CAGR are 109%, 13.5%, and 12.1% for the company, its peers, and the S&P 500 index, respectively. Maybe this is what CFRA means by lack of stability?
If anyone on this board, such as MauMar or Fred Kadiddlehopper, cares to comment, I'd be quite interested in your views.
Happy New Year to all.
Happy and healthy New Year to you too.
Followers
|
101
|
Posters
|
|
Posts (Today)
|
1
|
Posts (Total)
|
8606
|
Created
|
07/24/06
|
Type
|
Free
|
Moderators Fred Kadiddlehopper |
http://www.halozyme.com
Halozyme is a biopharmaceutical company developing and commercializing products based on the extracellular matrix for the drug delivery, oncology, and dermatology markets. The company's portfolio of products is based on intellectual property covering the family of human enzymes known as hyaluronidases.
The company's Enhanze Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. Its first partnership is with Roche to apply Enhanze Technology to Roche's biological therapeutic compounds for up to 13 targets. In addition, the company has received FDA approval for two products: Cumulase® and HYLENEX, for use as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids. HYLENEX is partnered with Baxter Healthcare Corporation. The Company also has a number of different enzymes in its portfolio that are targeting significant areas of unmet need.
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
Products/Pipeline
Halozyme is a therapeutically driven biopharmaceutical company developing and commercializing recombinant human enzymes to provide enhanced and innovative alternatives that improve the practice of medicine. Halozyme is focused on providing life-saving and life-enhancing solutions to the drug delivery, oncology, and dermatology markets.
The foundation of our capabilities is our recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a structural protein in the interstitial space. This temporary alteration provides an opportunistic window that allows the delivery of injectable biologics such as monoclonal antibodies, as well as small molecules and fluids. With our enzyme, many pharmaceuticals that would normally be injected intravenously (IV) can be administered subcutaneously (SC). This change in route of delivery may improve patient convenience, enhance pharmacokinetics, boost efficacy, extend the product lifecycle, and reduce cost, in addition to other attributes.
Four key internal programs comprise our current proprietary product development portfolio. The endocrinology franchise consists of Insulin-PH20, which applies our PH20 enzyme to currently approved and marketed insulin products. The oncology franchise consists of PEGPH20, a new molecular entity administered intravenously that targets the external environment of tumor cells, and Chemophase, which utilizes the PH20 enzyme for local administration in bladder cancer. Our lead enzyme in the dermatology franchise, HTI-501, is a new molecular entity which digests collagen and may have applications in both medical and aesthetic dermatology such as cellulite.
Our product development pipeline also includes three distinct partnered programs with two companies; Roche and Baxter BioScience for Enhanze technology, and a partnership with Baxter Medication Delivery for Hylenex, our FDA-approved drug. These partnered programs validate our technology and may generate clinical and commercial milestone revenue based on the achievement of pre-specified events along with sales royalties when products reach the commercial stage. We utilize the cash milestone payments generated from the partnered programs as a source of development funding for our proprietary pipeline projects.
Endocrinology
Our endocrinology development activity focuses on insulin, a mainstay of treatment for people with diabetes. This program combines our PH20 hyaluronidase enzyme with insulin, a frequently prescribed, commercially successful pharmaceutical already approved and on the market.
We believe that the combination of our PH20 enzyme with existing, meal time insulin products such as regular insulin or a fast acting analog could lead to a best-in-class product that more closely mimics the release of natural insulin in the body. The results of a Phase 1 study, where we combined PH20 with Humulin® R (regular human insulin) and with Humalog® (insulin lispro), demonstrated significantly faster and higher insulin plasma concentrations compared to either insulin alone. Faster acting insulin could provide patient benefits such as reduced hypoglycemia, lower intra-subject variability, and less weight gain. These potential benefits would be significant but must first be demonstrated and proven in clinical development.
Our first Phase 2 clinical trial with insulin began in October 2008 and enrolled Type 1 diabetic patients. Data presented from our Phase 1 trial showed that the administration of regular insulin and an insulin analog with our PH20 enzyme led to faster insulin absorption and more rapid effects than either insulin alone. Our Phase 2 trial is designed to demonstrate similar results in Type 1 diabetic patients. We hope to present preliminary Phase 2 results at the American Diabetes Association meeting in June. Additional clinical trials are planned in 2009.
ONCOLOGY
Hyaluronan (HA) is a component of the extracellular matrix that frequently accumulates in human cancers. The quantity of HA produced by the tumor cells directly correlates with increased tumor growth and metastasis and it has been linked with tumor progression and poor prognosis. Previous clinical trials of bovine hyaluronidase showed promise in enhancing chemotherapy regimens using adjunctive systemic hyaluronidase in chemo-refractory patients. In animal studies the removal of HA from tumors with hyaluronidase has demonstrated improved survival, suppression of tumor growth, and enhanced efficacy of certain anti-cancer drugs. Chemotherapeutic agents may be able to better penetrate the tumor once the HA has been removed.
We have also observed significant reduction of tumor interstitial fluid pressure (IFP) following the administration of rHuPH20 in solid tumors grown in mice. Tumor interstitial pressure is widely believed to be an important factor limiting the access of cytostatic regimens to solid tumors. By digesting the HA gel, rHuPH20 may reduce IFP in the tumor and promote more effective delivery of chemotherapy throughout the tumor. This could potentially lead to better patient outcomes and increased survival.
Our PEGPH20 program utilizes pegylated hyaluronidase that allows for intravenous administration to degrade the HA that surrounds tumor cells. The Chemophase program applies the hyaluronidase enzyme along with mitomycin C directly into the bladder where the enzyme can hydrolyze the HA produced by the cancerous bladder cells. Unlike tumor cells, normal cells do not produce HA in this manner and appear not to be adversely affected by the enzyme.
We are investigating pegylated-rHuPH20, or PEGPH20, a new molecular entity, as a candidate for the systemic treatment of tumors rich in hyaluronan, or HA. Pegylation refers to the attachment of polyethylene glycol to our rHuPH20 enzyme, which extends its half life from less than 30 seconds to more than 24 hours. Numerous solid tumors, including prostate, breast, pancreas, colon and non-small cell lung, accumulate HA that forms a halo like coating over the surface of the tumor cell.
In preclinical studies, PEGPH20 has been shown to remove the HA coating surrounding several tumor cell lines. Treatment of PC3 (a prostate cancer cell line that produces HA) tumor bearing mice with PEGPH20 as a single agent demonstrated approximately 70% tumor growth inhibition relative to controls. Repeat dosing with PEGPH20 produced a sustained depletion of HA in the tumor microenvironment. For tumor models that do not produce HA, the presence of PEGPH20 has no effect. An estimated 20% to 40% of certain solid tumors may produce HA.
Administration of the combination of PEGPH20 with docetaxel or with liposomal doxorubicin in HA producing animal tumor models produced a significant survival advantage for the combination relative to either chemotherapeutic agent alone. Therefore, based on these animal studies and other tests conducted by Halozyme, PEGPH20 may represent a potentially innovative treatment approach against tumors that produce HA.
PEGPH20 recently started its first Phase 1 clinical trial which will evaluate the agent over a range of doses. The study will enroll up to 46 advanced cancer patients who will receive treatment cycles of intravenous PEGPH20 as a single agent twice weekly for three weeks followed by one week without dosing. Patients may continue subsequent cycles at their assigned dose as long as there is no tumor progression and no unacceptable toxicity. Groups of four to eight patients will be in each dosage cohort. The primary outcome measures of the study will be to evaluate safety and tolerability of PEGPH20 and to determine the recommended single agent Phase 2 dose. Secondary objectives will be to determine pharmacokinetics, obtain dose limiting toxicities, and observe patients for any evidence of anti-tumor activity.
Chemophase is a chemoadjuvant we have investigated for possible use in the treatment of patients with superficial bladder cancer, which represents a smaller potential market than our other proprietary pipeline opportunities. The Chemophase program combines our PH20 enzyme with mitomycin C, a cytotoxic drug, for direct administration into the bladder immediately after transurethral resection of bladder tumors (TURBT), a standard surgical treatment for the disease. Many bladder tumor cells produce high quantities of HA and thus treatment to remove the HA coating could increase their exposure to mitomycin C. This may lead to a lower recurrence of the cancer and a better prognosis for patients.
In June 2008, we announced the interim results of a Phase I/IIa clinical trial in which the Chemophase combination treatment of mitomycin C plus rHuPH20 enzyme was well tolerated and appears safe. The study reported no dose-limiting toxicities and no observed side effects attributable to the enzyme. An ongoing safety trial involves the immediate post operative (IPOP) administration of PH20 and mitomycin directly into the bladder of patients after a TURBT procedure.
DERMATOLOGY
The foundation of our dermatology program is HTI-501, a human lysosomal proteinase that degrades collagen. It may be useful in the treatment of both medical and aesthetic dermatologic conditions such as cellulite, Dupuytren’s contracture and Peyronie’s disease. This pH sensitive enzyme demonstrates activity under mildly acidic conditions but shows no activity at normal physiologic pH. This attribute may be harnessed to exert control over the duration and location of the enzyme’s therapeutic activity.
Tests with HTI-501 in several animal models have produced encouraging results and our pre-clinical investigations of the enzyme will continue throughout 2009.
ENHANZE
Enhanze™ Technology, a proprietary drug delivery platform using Halozyme’s first approved enzyme, rHuPH20, is our broader technology opportunity that can potentially lead to partnerships with other pharmaceutical companies. When co-formulated with other injectable drugs, Enhanze Technology may facilitate the penetration and dispersion of these drugs by temporarily opening flow channels under the skin.
Molecules as large as 200 nanometers may pass freely through the extracellular matrix, which recovers its normal density within approximately 24 hours, leading to a drug delivery platform which does not permanently alter the architecture of the skin. The principal focus of our Enhanze Technology platform is the use of rHuPH20 to facilitate subcutaneous or intramuscular routes of administration for large molecule biological therapeutics. We are seeking partnerships with pharmaceutical companies that market drugs requiring or benefiting from injection via the subcutaneous or intramuscular routes that could benefit from this technology. In December 2006, we signed our first Enhanze Technology partnership with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche, Inc. In September 2007, we signed our second Enhanze Technology partnership with Baxter Healthcare Corporation and Baxter Healthcare S.A.
HYLENEX
Full prescribing information is available below or at www.hylenex.com
Hylenex is a human recombinant formulation of rHuPH20 to facilitate the absorption and dispersion of other injected drugs or fluids. When injected under the skin or in the muscle, hyaluronidase can digest the hyaluronic acid gel, allowing for temporarily enhanced penetration and dispersion of other injected drugs or fluids. We filed a New Drug Application (NDA) in March 2005 and we received approval of our Hylenex NDA in December 2005.
Hylenex may facilitate subcutaneous delivery of fluids up to one liter without the need for intravenous access, a procedure known as EASI. Importantly, EASI for fluid replacement in terminal patients may be achieved with limited or no need for nursing assistance. Over 1.1 million subcutaneous fluid infusions are performed per year with hospice patients alone (Source: Company estimates based on National Hospice and Palliative Care Organization data, 2001). In addition, over 500 million infusion bags are utilized annually in the United States, some of which could potentially convert to EASI using Hylenex, giving rise to additional market potential (Source: B. Braun, 2003).
During January 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Lactated Ringer’s clinical trial, or INFUSE-LR study, which was designed to determine the subcutaneous (Sub-Q) infusion flow rate of Lactated Ringer’s solution with and without Hylenex, determine the Sub-Q infusion flow rate dose response to Hylenex over one order of magnitude of dose, and assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 54 volunteer subjects who received Sub-Q infusions simultaneously in both upper arms through 24 gauge catheters.
During October 2006, we completed the INcreased Flow Utilizing Subcutaneously-Enabled Morphine clinical trial, or INFUSE-Morphine study, which was designed to determine the time to maximal blood levels of morphine after subcutaneous administration with and without Hylenex, to determine the time to maximal blood levels after intravenous administration of morphine, and to assess safety and tolerability. This prospective, double-blind, randomized, placebo-controlled, within-subject, dose-comparison study enrolled 12 evaluable patients who received Sub-Q infusions.
For full prescribing information, visit www.hylenex.com or www.baxter.com.
CUMULASE
Cumulase is an ex vivo (used outside of the body) formulation of rHuPH20 to replace the bovine enzyme currently used for the preparation of oocytes (eggs) prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The enzyme strips away the hyaluronic acid that surrounds the oocyte. This allows the clinician to then perform the ICSI procedure, injecting the sperm into the oocyte. The FDA considers hyaluronidase IVF products to be medical devices subject to 510(k) approval and we filed our 510(k) application during September 2004.
We received FDA clearance in April 2005. We launched Cumulase in the European Union and in the United States in June 2005. We believe the total ICSI market consisted of an estimated 500,000 intracytoplasmic sperm injection cycles worldwide in 2005 (Source: CDC, 2001; ESHRE, 2002).
Visit www.cumulase.com for more information.
Informative Links
http://www.nasdaq.com/asp/Holdings.asp?FormType=Institutional&page=holdingssymbol=HALO&selected=HALO
(Institutional Holdings)
http://www.cnbc.com/id/15837275?q=HALO
(Big Block Holders from CNBC)
http://www.sec.gov/edgar/searchedgar/companysearch.html
(SEC filings search from SEC.gov Edgar)
http://www.nasdaqtrader.com/Trader.aspx?id=shortinterest (Short Interest)
http://www.newratings.com/main/search_result.m?section=search
(Analyst Ratings)
http://www.insidercow.com/history/company.jsp?company=HALO&B1=Search%21
(Insider Transactions)
http://clinicaltrials.gov/ct2/results?term=rhuph20
http://clinicaltrials.gov/ct2/results?term=hyaluronidase+%28human+recombinant%29
(Clinical Trials)
Clinicals & Partners
http://media.corporate-ir.net/media_files/irol/17/175436/120506RocheHalozymePR.pdf
Halozyme and Roche enter agreement for the application of Enhanze, a novel technology to improve drug delivery
http://media.corporate-ir.net/media_files/irol/17/175436/RocheHalozymeSCRIPPresentation.pdf
(Halozyme and Roche presents “Developing and Managing Strategic Alliances” at the SCRIP conference
May 15-16, 2007 Berlin, Germany)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1049931&highlight=
Baxter and Halozyme Announce Collaboration for Development of Subcutaneous GAMMAGARD LIQUID(TM) Administration Using Enhanze(TM) Technology
http://www.genengnews.com/news/bnitem.aspx?name=32185399
Baxter Presents Latest Clinical Trial Results of GAMMAGARD LIQUID Administered Subcutaneously (Enhanze 3-16-08)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=962993&highlight=
Halozyme and Baxter Expand Global HYLENEX Collaboration
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=IROL-secToc&TOC=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvY29udGVudHMueG1sP2lwYWdlPTU0NDgxMjkmcmVwbz10ZW5r (Feb. 12, 2008 Slide Show Presentation)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1093211&highlight=
Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1117082&highlight=
Halozyme Therapeutics Presents Favorable New Safety and Pharmacokinetic Data on rHuPH20 Enzyme Produced Via New Manufacturing Process at European Federation for Pharmaceutical Sciences
Halozyme Therapeutics Presents Findings on Combinations of rHuPH20 Enzyme With Bisphosphonates at the American Association for Cancer Research Conference
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1130327&highlight=
Halozyme Therapeutics Presents Pre-Clinical Studies on Dermal Remodeling With HTI-501, a Lysosomal Proteinase
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1147853&highlight=
http://www.baxter.com/about_baxter/news_room/news_releases/2008/03-16-08-gammagard_liquid.html
Phase I/II data showed that Enhanze Technology™ enabled subcutaneous administration of a monthly dose of GAMMAGARD LIQUID in patients with Primary Immunodeficiency
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1163612&highlight=Halozyme Therapeutics Announces Phase I Clinical Trial Results Demonstrating that the Combination of Recombinant Human Hyaluronidase (rHuPH20) With Humulin R(R) and with Humalog(R) Yields Faster, More Physiologic Insulin Kinetics and Better Predictability
Cheetah full ADA presentation
http://www.halozyme.com/images/ADA%202008%20Poster%20legal.pdf
Halozyme Therapeutics Announces Positive Findings With Pegylated Enzyme in Prostate Cancer Models
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1177539&highlight=
Halozyme Therapeutics Announces That Chemophase Meets Primary Endpoint in Phase I/IIa Clinical Trial
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1170737&highlight=
Halozyme Therapeutics Begins Phase 2 Clinical Trial of Insulin With rHuPH20 in Type 1 Diabetic Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1220870&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial and Selects Fourth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1233454&highlight=
Halozyme Therapeutics Begins Phase 1 Clinical Trial of Bisphosphonate Administered With rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1234643&highlight=
Halozyme Deprioritizes Bisphosphonate Program to Reallocate Resources to More Commercially Attractive Internal Programs
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1295922&highlight=
Phase III Trial Begins for GAMMAGARD LIQUID Plus rHuPH20 in Primary Immunodeficiency Patients
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1240232&highlight=
Halozyme Therapeutics Announces Roche Begins Phase 1 Clinical Trial With Second Biologic
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1244971&highlight=
Halozyme Therapeutics Presents Positive Pre-Clinical Single Agent Data for PEGPH20
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1248119&highlight=
AACR presentations show that PEGPH20 produces anti-cancer activity in models of breast, prostate, and brain metastases that produce hyaluronan
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1277960&highlight=
Phase 1 Study for Halozyme's Insulin-PH20 Published, Highlights Findings for Faster Acting Insulin Formulations |
|
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1293715&highlight=
Accelerated Insulin Pharmacokinetics and Improved Glycemic Control in T1DM Patients by
Coadministration of Prandial Insulin with Recombinant Human Hyaluronidase
http://www.halozyme.com/ADA%202009%20Poster%20v3%202.pdf
Halozyme Announces Roche Selects Fifth Exclusive Biologic Target
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1297519&highlight
Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID(TM) with rHuPH20 Enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1307856&highlight=
First patient dosed in trial with third Roche biologic formulated with Halozyme’s recombinant human hyaluronidase enzyme
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1330295&highlight=
Baxter Announces the Commercial Launch of HYLENEX at ACEP for Use in Pediatric Rehydration |
Data from the First Pediatric Rehydration Study, INFUSE-PEDS 1, Published Today in Pediatrics |
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1338559&highlight=
Halozyme Announces Roche Doses First Patient in Phase 3 Clinical Trial with Subcutaneous Herceptin(R)
http://phx.corporate-ir.net/phoenix.zhtml?c=175436&p=irol-newsArticle&ID=1344910&highlight=
Earnings Transcripts
http://seekingalpha.com/article/68609-halozyme-therapeutics-q4-2007-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Q4 2007 Earnings Call Transcript
http://seekingalpha.com/article/76655-halozyme-therapeutics-inc-q1-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics Inc. Q1 2008 Earnings Call Transcript
http://seekingalpha.com/article/90080-halozyme-therapeutics-inc-q2-2008-earnings-call-transcript?source=yahoo&page=1
Halozyme Therapeutics Inc. Q2 2008 Earnings Call Transcript
http://seekingalpha.com/article/106797-halozyme-therapeutics-inc-q3-2008-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2008 Earnings Call Transcript
http://seekingalpha.com/article/125929-halozyme-therapeutics-inc-q4-2008-earnings-call-transcript?source=trans_sb_previous
Halozyme Therapeutics, Inc. Q4 2008 Earnings Call Transcript
http://seekingalpha.com/article/171883-halozyme-therapeutics-inc-q3-2009-earnings-call-transcript?source=yahoo
Halozyme Therapeutics, Inc. Q3 2009 Earnings Call Transcript
Links to understanding Clinical results
http://www.boomer.org/c/p3/c02/c0210.html
http://health.yahoo.com/other-other/picomoles-per-liter-pmol-l/healthwise--stp1694.html
http://www.unc.edu/~rowlett/units/scales/clinical_data.html
http://www.bio.net/bionet/mm/immuno/2000-July/015983.html
http://www.boomer.org/c/p1/
http://www.merck.com/mmpe/sec20/ch303/ch303a.html
Shares Outstanding: 91,095,288
Float: 73.21M
http://www.deepcapture.com/
(O-T How the market is manipulated and companies destroyed)
Halozyme Therapeutics Inc.
11588 Sorrento Valley Road
Suite 17
San Diego, CA 92121
United States
Phone: 858-794-8889
Halozyme Contact
Robert H. Uhl
Senior Director Investor Relations
858.704.8264
ruhl@halozyme.com
(Disclaimer) Do your own DD and confirm anything said on this board.
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |