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That might be true and ultimately a good strategy. However, she should have never guided 3 deals for 2023 (including a HVAI) and still not delivered 9 months into 2024.
Despite of this shortcoming, halozyme is still a bargain.
FWIW, here's my theory on why new deals are being delayed.
As I mentioned in a previous post, a letter to the editor in Barron's a few weeks ago said that CMS is going to come out with more detailed regulations this fall regarding the ground rules for the next round of drug price negotiations. These new regs will spell out, among other things, whether developing a new, subcutaneous version of a blockbuster drug previously administered IV is a big enough change to justify resetting the clock and effectively postponing the day of reckoning when a Big Pharma will have to negotiate prices with Medicare for one of its best-selling products. As I recall, Merck is betting on this scenario by investing many millions in a subQ version of its blockbuster pembrolizumab (Keytruda).
If the letter writer is correct, and Helen believes the regulations coming out this fall will strengthen her hand in negotiating royalties, then it may be in her interest to wait until after the updated regs are issued to finalize a deal. If she is right, they will strengthen her hand in negotiating higher/richer royalties of maybe in the low double digits. If she is wrong, then her fallback position would be the mid-single digit percentage royalty deals she's been negotiating with partners all along.
These are multi-year royalty deals we're talking about, with big implications for revenue over an extended period, so it may be in Halo's best interest to wait, especially if Helen thinks the new regs will strengthen her negotiating position.
-- OJ
I concur with this post from another board regarding JPM’s rating earlier today:
“Not only this analyst is a joke, but the investors following him are unable to read by themselves: EPS grows by 40% this year, 20% next year, 25% in 2026 and 2027.
PE is 16, ROE is 150%! EV/S seems high at 10. But the revenue has high gross margin (70%) as half is made out of royalties (higher percentage next years). This is a typical Warren Buffett stock, although the visibility is limited until 2028 now.
The development risk with this pharma is very low as it uses a better modality to deliver pre-existing blockbusters. It is difficult to find something as boring as this with high growth and low risk. This is shooting fish in a barrel, per Charlie Munger.”
Here is why while you are right about Helen’s inability to deliver new deals (2023-2024 so far), you are wrong about the direction of the share-price.
Page 14 on
https://s28.q4cdn.com/284259014/files/doc_financials/2024/q2/HALO-2Q24-Earnings-Deck-FINAL-FINAL-004.pdf
EVEN WITHOUT A SINGLE NEW DEAL, the top and bottom lines are projected to grow over 20% per year until at least 2028. Also, despite the recent run up, halo is still trading at a forward (2024) PE of around 16 and PEG of 0.6
https://www.nasdaq.com/market-activity/stocks/halo/price-earnings-peg-ratios
Halozyme is a great bargain and will be trading much higher over time even without new deals and despite the current management shortcoming.
If we get new deals or a new CEO, it would be icing on the cake.
There are some crazy posts...glad biotechinvestor1 isn't one of them...
Thank you!
It’s hard to fathom what is going on with Helen. If I remember correctly, she started promising 3 new deals in early’23!!! It’s kind of risky for a CEO to lie. Is she delusional? What serious potential partners would spend 10-12 months “discussing” a simple licensing deal? I find it absurd. And what about the board? Can’t they see the horrible stock performance? We are barely 20% up from Feb ‘21 in spite of Darzalex Faspro’s tremendous growth. Are they all happy to rest on their laurels, bury their heads in the sand, and cash in their stock options? How long has it been since we had a Chief Medical Officer? Do they really believe that they have no competition, “they are the only game in town”, “everyone else is really early”?
Someone should let them know that stocks are about the future. I am not sure what else Alteogen has in the pipeline but SC Keytruda has not been approved, and yet their market cap is almost 14 billion dollars. The stock is up over 350% from a year ago, 3,390% from 5 years ago.
No. If history can be a guide (your posts over the past several years are here on this board for anyone to see), you will post a series of bearish posts that will defy the fundamentals and realities of halozyme. Halozyme will continue to appreciate in price. Later in the share-price run up, you will claim that you had been long that whole time but that there are better investments out there than halo. Then you will disappear.
Nonetheless, your posts are entertaining and always appreciated.
The company is fine. After the last call I felt the stock would “drift”. While its drifted nicely up (over 10 percent after this sell off) there’s still a chance we could go lower especially since this quarter is going to be flat. They will deliver in new deals at some point but drifting until then.
A predictable yawner… I encourage you to buy, “hand-over-fist” this “juicy bargain”. Enjoy yourself now, Bubba, at least as far as my account goes, the days of joy are numbered. Just as I said, I am outa here come late October. I will be very pleased to flash such a bullish sign for you, and lick my wounds in misery.
Yes! Easycomeandgo is back posting on this board. Welcome back. Order is restored. Our full set of permabears are all well and posting again.
Very bullish sign! Dips are to be bought hand-over-fist.
Come on Mr. Market give us more juicy bargains.
Look at the permabears get all excited for a neutral rating by JPM. These are the same permabears who were forecasting doom and gloom when we were in low $30’s (as well as $20’s and teens). We have doubled in share-price since. Now with a neutral analyst rating and a 5% share-price drop, they claim they have been right all along.
The amusing part is that despite the neutral rating, JPM raised its target price! Notice they don’t think we are heading back to the $30’s where these permabears were bearish.
There are plenty other (majority of) analysts with buy ratings and much higher price targets (some in the $70’s). Morgan Stanley has provided some of the best research/coverage on halo over the years. They raised their target price from $59 to $64 just last month and maintained a buy rating.
Overall, I’m happy to see permabears back posting with excitement. Historically, this has been a bullish sign.
I did not have any idea about how any outfit was going to rate HALO stock, but this is about what I feared in terms of outlook when I lamented that the majority of my remaining position would not go long term until October. Since then, I have sold what I could, 25% of my position had gone long term. No regrets about selling. I know that the issuer of permabear shareholder ratings (such delightful wit) is going to now savor the moment and declare even more dire insights into the minds of fellow shareholders. I continue to believe, without knocking HALO, that better investment avenues exist at this moment. Not bearish, just not bullish. There does exist a neutral avenue.
Exactly. Happy talk from Helen is not going to cut it anymore. The more time that goes by without a deal, the more one suspects she is not capable of running this company and has been not telling the truth about HALO's future prospects. Time is running out, and quickly.
JPM: “ Despite raising our price target to reflect more value for future product royalties, we struggle to find a strong upside case from current levels that does not rely on giving even more credit. With the stock now at $62/sh, we are moving to the sidelines and lowering our rating to reflect HALO trading at a level we see as fully valued. What could get us more constructive from here? 1) the announcement of partnership(s) with attractive economics, ideally from large biopharma companies that reinforce the long-term value of the Enhanze platform and 2) more visibility into the performance of Wave 4 and Wave 5 products. Our recent conversations with the company suggest that there are up to 20 open slots across existing partners that have yet to be nominated for development, and that HALO is in “broad-based” discussions with pharma and biotech companies for new deals. We believe the bigger the partner, the more it will reinforce the value of HALO’s platform as we edge closer to the Enhanze LOE. Bigger picture, with HALO stock blowing past even our updated, higher valuation, we struggle with the case for further upside relative to other stocks in our coverage and would revisit this based on changes in the story and/or stock price.”
As I feared, JPM downgraded to neutral even though they raised their Dec. ‘25 PT from $52 to $57. They are moving to the sidelines because they feel it is more than fully valued. Basically, they want to see the “broad-based” discussions turn into new partnerships. The bigger the partner, the more it will validate the Enhanze platform, a hint that another partnership with a tiny company like ABOS will not cause them to upgrade. It’s not exactly encouraging that their Dec. ‘25 is lower than the Nov ‘22 high.
I get emails from refinitive which gives me updates. Don’t have a link.
I get emails from refinitive which gives me updates. Don’t have a link.
Where did you see that? Link?
Benchmark upped to 75 price target from 60.
From Artisan:
"Halozyme Therapeutics surged higher after it reported better-than-expected Q2 results and reconfirmed its current-year guidance. Cash flow growth during the quarter was driven by a 12% increase in royalty revenues, although we note that some of these revenues were pulled forward from Q3 to Q2. Based on talks management is having with other biotech companies, we think the company will secure more new deals this year to license its ENHANZE® drug delivery platform. We value Halozyme’s high cash flows, which it has used to support share buybacks."
I see a proper return and a short squeeze next week. Hold onto those shares
"The company recently reported that it has 10.04 million shares sold short, which is 10.74% of all regular shares that are available for trading. Based on its trading volume, it would take traders 7.75 days to cover their short positions on average"
I see the market doesn't agree that it's a 'gimmee'.
Not to the dedicated few. Neither milestone payments could be included in year end financials nor near term income.
Neither of these approvals is much of a surprise.
The cadence with halo at least for 2024 has been to run up ahead (weeks to months) of anticipated catalysts, then take a haircut (5-10%) a week (or two) before the news release and then resume a sustained run up.
FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection
On September 12, 2024, the Food and Drug Administration approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Genentech, Inc.) for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab (Tecentriq, Genentech, Inc.), including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), melanoma, and alveolar soft part sarcoma (ASPS). See the prescribing information for the specific indications.
Source: usfda@public.govdelivery.com
-- OJ
I've been in since $1.88 and I'll be half out at $80. Then let it ride
I think Helen has a better understanding of the new partnerships in the pipeline.
I feel ya though, I'm tired of hearing "In final talks", regarding partnerships. Time to sign, my dear
Another nibble @ 58.98.
I'm thinking a 10% jump (if it's an up market day), Followed by a pullback to 5-8% gain, the following day.
Based on drug valuation, historical reactions, 52 week high and mostly the markets emotional response.
I hope the longs had a chance to load up more :)
Atezolizumab SC approval on slide 5.
September 15, 2024.
This is a Sunday. Does the FDA announce things on a Sunday?
I would hope that CDMO is picking up the difference since their large expansion. Still don't know why they don't buy CDMO and have everything in house.
Something interesting :https://finance.yahoo.com/news/q1-2025-avid-bioservices-inc-105934221.html. link from yahoo.
Avid Bioservices and Catalent are Halozymes fill and finish resources for the enzyme. Quote below is from Avid latest call ins the Q and A. Couple this question with the article below where the plants at Catalent are being sold to someone Halozyme is not that thrilled with and you wonder where is the excess product we are going to need in the future is going to come from.
"I wanted to ask about Halozyme, which obviously a key customer was over half your revenue in fiscal '23, but that was down to about a third and fiscal 2024.
Can you just give us an update around what exactly happened in fiscal 2023, how Halozyme revenues trended so far are trended so far in the first quarter and kind of what you're baking in for Halozyme revenue here in fiscal 2025 and just your overall level of visibility into revenue this year from this key customer?"
Couple this question with the article: https://finance.yahoo.com/news/novo-catalent-deal-affects-halozyme-081711085.html? When you read this you have to wonder what is Halozyme doing for production as the need for more product is going up every year.
Page 5 of Halo’s most recent Halozyme slide deck (see link below)
Upcoming Potential
Approvals
• Ocrelizumab SC (U.S.),
September 13, 2024
• Atezolizumab SC (U.S.),
September 15, 2024
• Nivolumab SC (U.S.)
December 29, 2024
But I’m not seeing Atezolizumab SC (U.S.) on FDA’s PDUFA date calendar!?
Does anyone else see it?
https://s28.q4cdn.com/284259014/files/doc_financials/2024/q2/HALO-2Q24-Earnings-Deck-FINAL-FINAL-004.pdf
Thank you, Mr. Market for giving us a chance to load up with a 10% discount (from recent all time high) ahead of the two blockbuster ENHANZE/halozyme PDUFA dates next week
Good that they have money to count. And yes Merck is late to the party. They should have SC keytruda on the market by now.
Ok great, I am convinced, a company with a billion dollar product has no competition, no other company has any interest now and never will, cool. And Merck are fools for wasting time and money on a worthless product, idiots.
Go HALOoooooooo up please.......with no competition in the future, it is clear sailing up.
P.S. Nice Housnlab pipeline chart Howeeme, wish that the no competition company HALO would have a helpful informative pipeline an investor could quickly look to determine what is it they are working on. Guess they are to busy counting their money and not looking behind for the non-existing competition.
https://huonslab.com/layout/eng/home.php?go=pipeline. They are a long way away from anything.
Merck is late to the game. Years away from any approval. If anything they will lose share to opdivo.
Sorry, some of the comments are a bit confusing, not sure what some are trying state.
In any case, I see them as competition and will continue following the progress being made.
Patent filings by both Alteogen and Merck, along with clinical trials, shows Merck is making progress on Hybrozyme (ALT-B4, MK-5180). Merck is actually carrying the heavy load, while Alteogen reaps benefits.
IMO, Merck is pushing thru with the MK-5180 because in the long run it will be significantly cheaper then dealing with HALO. They will also have control of the product and will be cheaply expanding it into other products, making their products more competitive.
https://www.oncologypipeline.com/apexonco/mercks-subq-keytruda-headscratcher
Coded MK-3475A, co-formulation with Alteogen's MK-5180 (rh hyaluronidase)
https://www.freepatentsonline.com/y2024/0150467.html
COMPOSITIONS AND METHODS FOR TREATING CANCER WITH SUBCUTANEOUS ADMINISTRATION OF ANTI-PD1 ANTIBODIES
https://www.freepatentsonline.com/WO2024091417A1.html
HUMAN HYALURONIDASE 1 MUTANTS
https://clinicaltrials.gov/study/NCT06504394
A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Hyaluronidase (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)
Huonslab's Hydiffuze is same sequence with halo's
after few years, Huonslab is not competitor
Okay, thanks. I forgot about that and I guess Tecentriq is PD- L1 so they were allowed to use it.
It's very easy to buy both stocks!
nowadays, many Koreans buy a US stocks instead of Korean stocks.
well, i think it just 'TIME' view
Until just a few years ago, SC injection did not get noticed in the market.
Merck needed a means to defend the patent expiration, They realized that the IV to SC change was the answer.
But, Halo was already under contract with BMS(PD-1 exclusive), so they found alteogen
In Korea, there lots of reports of this.
Alteogen has found a way to evade ENHAZE's patents, which it has been granted registration permission by the PCT and U.S. Patent and Trademark Office, and they are bolstering the patent chain to prevent the entry of competitors other than Halo and Alteogen.
I think that they were trying to sell Merck on the idea by testing on their own many years ago. Merck never bit on this. Big mistake!!!
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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 |
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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
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Float: 73.21M
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(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.
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