Earnings Labs

Halozyme Therapeutics, Inc. (HALO)

Q2 2008 Earnings Call· Fri, Aug 8, 2008

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Transcript

Operator

Operator

Good morning, ladies and gentlemen. My name is Ashley and I will be your conference operator today. At this time, I would like to welcome everyone to the Halozyme Second Quarter 2008 Pipeline Update Conference Call. [Operator Instructions].Thank you. Mr. Robert Uhl, you may begin your conference.

Robert Uhl - Senior Director of Investor Relations

Analyst

Thank you, Ashley and thanks also to everyone for participating in today’s call. I am Robert Uhl, Senior Director of Investor Relations at Halozyme Therapeutics. Joining me on the call today from Halozyme are Jonathan Lim, President and Chief Executive Officer; Gregory Frost, Chief Scientific Officer, David Ramsay, Chief Financial Officer and Robert Little, Chief Commercial Officer. This morning Halozyme released 2008 second quarter financial results. If you have not received this news release, or if you would like to be added to the company’s distribution list, please call Alex Schlam at 858-704-8288. This call is also being webcast live over the Internet at www.halozyme.com and a reply will be available on the company’s website for the next 30 days. Before we begin, let me remind you that during this conference call, we will be making forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides the Safe Harbor for forward-looking statements. All statements made during this conference call that are not statements of historical facts constitute forward-looking statements. The matters referred to in forward-looking statements could be affected by the risks and uncertainties of Halozyme’s business both known and unknown. Such risks inherent to Company’s business are described in our filings with the Securities and Exchange Commission, as well as in our press releases. The company’s actual results may differ materially from those expressed and/or indicated by such forward-looking statements. With that I’d like to now turn the call over to Halozyme’s President and CEO, Jonathan Lim. Jonathan Lim – President and Chief Executing Officer: Thank you, Robert. Good morning, everyone. Thank you for joining us especially on this auspicious day of 08-08-08. I’m excited to be able to give you an update on the substantial progress that Halozyme has made since our last conference call on our…

Gregory Frost - Chief Scientific Officer

Analyst

Thanks, Jonathan and good morning everyone. I’d like to start off with an update on our two oncology programs. Intravenous PEG PH20 for solid tumors and Chemophase for bladder cancer followed by brief updates on our dermatology and bisphosphonates R&D efforts. Last month we presented efficacy date at the AACR Translational Cancer Medicine meeting in Monterey. In animal tumor models with intravenous PEG PH20, alone ending combination with either docetaxel and liposomal doxorubicin. Hyaluronan or HA is a dominant component of the extracellular matrix in subsets of many solid tumors that may increase resistance to Chemotherapy. Earlier this year we demonstrated that removal of HA around the tumor with our novel PEG PH20 enzyme results in a reduction in tumor size that exceeds NCI criteria to be considered in anti-tumor agent. HA removal also leads to significant reductions in tumor interstitial fluid pressure or IFP. And tumor Diffusion-weighted MRI signals. Many experts believe that elevated tumor IFP may limit the response to cytotoxic treatment regimens in multiple solid tumors. Our most recent studies clearly demonstrate a substantial increase in anti-tumor activity for a combination of PEG PH20 with these two chemotherapy agents. For example, in the xenograph PC-3 prostate cancer model, a tumor that produces abundant pericellular HA, tumor volume growth over time was significantly reduced and survival significantly prolonged for the PEG PH20 plus docetaxel treatment group compared to the control and docetaxel alone groups. In addition significant reductions in tumor mass were observed following treatment with pegylated enzyme alone that bears further investigation of monotherapy activity in HA expressing tumors. In contrast, using a prostate tumor model that does not produce HA, the xenograph D-145 no significant changes in IFP (inaudible) intravenous PEG PH20 treatment, the results for this HA negative model also demonstrate a no meaningful difference…

Jonathan Lim - President and Chief Executive Officer

Analyst

Thanks, David. At this point I’d like to summarize for you, some of the goals and events that we expect will occurred within the next several quarters. And that further demonstrate the breadth and depth of our technology platform and our product franchisees. Commencement by the end of this year of the Phase II clinical program for PH20 insulin, a potentially best in class prandial insulin for the treatment of diabetes, initiation of a Phase I clinical trial for PH20 bisphosphonates, the only subcutaneous bisphosphonates for the treatment of osteoporosis in the fourth quarter of this year. Third is meeting with regulators to discuss the next clinical development steps for two programs, the Chemophase pivotal trails and superficial bladder cancer and the Phase I clinical trial for PEG PH20 in solid tumors. Finally, we’re anticipating initiation of the Phase III clinical trial in early 2009 by Baxter Bioscience for GAMMAGARD and Enhanze Technology. We look forward to future discussions with you regarding exciting progress we’re making with our preclinical and clinical efforts in our various programs. But, especially for our proprietary pipeline and to help the investment community achieve a deeper understanding of our scientific expertise and our business strategy, we’ll be hosting a Research Day for analysts on October 8, in New York City. So, please mark your calendars and hold the date. With that overview let’s open it up for questions. Operator? Ashley could we go forward with questions and answers now, please.

Operator

Operator

[Operator Instructions]. The first question is from Eun Yang with Jefferies.

Eun Yang

Analyst · Jefferies

Hi, thanks. I have a couple of questions on the diabetes program. First, Biodel has a similar product, the new drug delivery over insulin and clinical development and they are coming out with a Phase I data towards the end of this year. And, could you help us understand the advantages that you may have, your program may have over Biodel?

Jonathan Lim

Analyst · Jefferies

Sure. So, we both have Sub-Q formulations of different insulins, the power of PEG PH20 technology is the fact it can interface with either of the proprietary insulins better on the marketplace in terms of any one of the three analog insulins that are used for meal-time administration, the other thing is that we are able to co-formulated it with the regular insulin products, and as you can see we have a differentiated profile on both the PK and the PD dimensions for actually all of those products. We have ready to use formulation. So, we’re targeting basically a very simple to use administration via a pen type of system and also will be seeking to directly compare the performance characteristics of our product versus the best in class products that are on the market today.

Eun Yang

Analyst · Jefferies

They all show that the, not just the Humulin but they also show insulin analogs are using there drug delivery system, they were able to achieve a better insulin of absorption. So, far based on the Phase I data you have seen with PH20 and Biodel’s data, is there any, is it hard to differentiate how those two products are working differently or similarly?

Jonathan Lim

Analyst · Jefferies

Well, I’ll speak to the performance characteristics of our product and basically if you look at both the impact on the T-max or the time to maximal concentration and if you also look at the C-max or the maximal concentration itself the combination of PH20 with regular insulin and the combination of PH20 with basically the analog product you will see that there is a profound increase in the C-max for both products, both Halo products and there is also a profound decrease in T-max for both products. And, the overall area under the curve is increase where you wanted to increase which is the early time points. But, it also has significantly decreased where you wanted to decrease which is later on in the insulin absorption Phase to avoid the hypoglycemic events. So, for the same dose of insulin given with PH20, we believe that the T-max and the C-max from a pharmacokinetic profile are really compelling. And so, if you really want to do a true apples-to-apples types of comparison with similar doses I’d encourage looking at the T-max the C-max that area under the curve and just seeing what you can see there.

Eun Yang

Analyst · Jefferies

Okay, thanks. And then, a second question is on Phase II for insulin program planned for later this year, if I heard you correctly you said that it’s going to be in Type 1 diabetic patients?

Jonathan Lim

Analyst · Jefferies

That’s correct.

Eun Yang

Analyst · Jefferies

So, is there any particular reason or are there any reasons why you are limit to Type 1 versus Type 2?

Jonathan Lim

Analyst · Jefferies

Type 1 patients tend to have a more predictable profile in terms of the overall metabolic response. So, it tends to be a better patient population to do these early feasibility studies in terms of preferred concept.

Eun Yang

Analyst · Jefferies

Okay. And then the last question is in terms of like a potential outcome that you are predicting to see or like to see and one of them has kind of lesser weight gain and in Biodel’s study there actually saw some less weight gain with their product at six week timeframe. So, how long your study -- the question is how long your study is going to be and secondly how early, how soon can you see impact on the weight gain?

Jonathan Lim

Analyst · Jefferies

Yeah, it’s a good question. So, we are going to be exploring a number of Phase II studies in parallel, that look at such metrics as meal time glucose control, we are also going to be looking at patient variability amongst other basically endpoints that we can study very quickly. Weight gain is more of a long term type of metric that you would look at and so, in the context of our pivotal studies we would be looking at weight gain.

Eun Yang

Analyst · Jefferies

Okay, thanks.

Jonathan Lim

Analyst · Jefferies

You are welcome.

Operator

Operator

The next question is from Andrew Vaino with Roth Capital.

Andrew Vaino

Analyst · Roth Capital

It’s quick question on the 505B2 filing. I assume would you guys be using (inaudible) data as comparative data?

Jonathan Lim

Analyst · Roth Capital

We would be looking at basically referencing the data that’s already out there for regular insulin product.

Andrew Vaino

Analyst · Roth Capital

Okay. And secondly, as far as the location of your clinical sites, where will they be, is it going to be mostly North America?

Jonathan Lim

Analyst · Roth Capital

For the Phase II studies that’s correct.

Andrew Vaino

Analyst · Roth Capital

Okay, thank you.

Operator

Operator

The next question is from Kevin Degeeter with Oppenheimer.

Kevin Degeeter

Analyst · Oppenheimer

Hi, thanks guys. Couple of quick question if I may, one more on insulin here, for the analogs, what are you going to use in the Phase II, which product?

Jonathan Lim

Analyst · Oppenheimer

We were probably use Humalog because they are in broke wide fixed rate, so, Humalog and Humulin worked very well in the Phase I and so we use the same products.

Kevin Degeeter

Analyst · Oppenheimer

Alright. And maybe changing gears here a little bit on GAMMAGARD, I guess, Baxter is taking a little bit longer than they had previously thought to finalize their Phase III design for the Alzheimer’s study, does that have any impact on the timing and kick off for the Phase III combination on page 5?

Jonathan Lim

Analyst · Oppenheimer

No, none whatsoever, we were right on track, Kevin.

Kevin Degeeter

Analyst · Oppenheimer

Okay, perfect. And, do you hope to be above, I mean, with regard to Roche I recognized we received pre-limited news well here, I mean, is there any expectations in 2008 you will provide some levels specificity on that program at all?

Jonathan Lim

Analyst · Oppenheimer

Yeah, Kevin, as per Bob’s remarks we do hope to provide an update before the end of the year.

Kevin Degeeter

Analyst · Oppenheimer

And, that we would at the Analysts Day or perhaps some other venue?

Jonathan Lim

Analyst · Oppenheimer

Some other venue.

Kevin Degeeter

Analyst · Oppenheimer

Okay. Terrific, and I guess in terms of duration of treatment going back to diabetics for a moment, I’m assuming this initial Phase II is going to be relatively short perhaps I missed this?

Jonathan Lim

Analyst · Oppenheimer

That’s correct. The Phase II program that we were looking at is really for rapid proof of concept in diabetic patients as opposed to healthy volunteers.

Kevin Degeeter

Analyst · Oppenheimer

So, how single I mean injection, I mean, multiple over how many days can you?

Jonathan Lim

Analyst · Oppenheimer

Yeah there could be multiple injections but they will all be less than 28 days in duration in terms of the actual trial itself or the follow up during the trial.

Kevin Degeeter

Analyst · Oppenheimer

Okay, terrific. And I am assuming the next step would be type 2 patients?

Jonathan Lim

Analyst · Oppenheimer

That’s correct but we don’t necessarily have to do a Phase II study in a type 2 population but we are still mapping that out.

Kevin Degeeter

Analyst · Oppenheimer

Okay. I guess I’ll get back in queue and let some others to ask questions.

Jonathan Lim

Analyst · Oppenheimer

Okay.

Operator

Operator

The next question is from Chris Geston with UBS Financial Services.

Chris Geston

Analyst · UBS Financial Services

Actually, thank you. My questions have been answered. I appreciate it.

Operator

Operator

The next question is from John Borzilleri with GRT Capital.

John Borzilleri

Analyst · GRT Capital

Good morning, thanks. Couple of questions. I saw the press release on Chemophase and I see it hopefully you have identified a dose of 804 pivotal, is there any efficacy data from that trial you could give us? And the second is, my concern with the technology has been chronic safety, is it essentially dissolving tissue (inaudible) someone subcu for years or (inaudible) with the cancer. Can you talk about how you gain comfort or chronic use of the technology with drugs and data that will be generated on that front?

Gregory Frost

Analyst · GRT Capital

Sure, this is Greg Frost here. Let me try and answer those two questions specifically about Chemophase and secondly regarding chronic administration. So, the first one regarding Chemophase, that study is designed specifically it’s a single arm dosage relating study. So, what you are looking at in this population is the safety of intravascular exposure of the enzymes with the cytotoxic therapy and to be primary endpoint is establishing the safety, if you don’t have any serum exposure of the mitomycin that would actually cause neutropenia that’s above about 400 nanograms/ml likely cause neutropenia, a 100 nanograms/ml would be the base that we setup. And then in the context of giving that material with repeat administration of the duration of the therapy that’s effectively what we put in place to ensure that we can go through and get safe exposure over pivotal studies. So, because of these in the context that this is a relatively broad population from exposure, it’s not really in the efficacy data that we conclude from that but in the context of meeting of our endpoints is something that we consider to be a positive study. In the second perspective, regarding safe exposure of high levels of PH20 we had previous safety exposure in toxicology model demonstrating that have multiples of PH20 several logs above therapeutic doses that were effectively be no effect level. We also as Walter Bee had presented previously in the early part of the year completed recently toxicology studies with a nine month repeat exposure study by subcutaneous administration in non-human primates.

John Borzilleri

Analyst · GRT Capital

Okay. Can I just a follow up on the Chemophase I mean I guess I am having trouble understanding how you could have the dose to find for pivotal trial that have any efficacy data?

Gregory Frost

Analyst · GRT Capital

Well, that’s actually quite common with biologicals. So, in a biological you often don’t actually get a maximum tolerated dose and that effectively would be consistent with this compound as well.

John Borzilleri

Analyst · GRT Capital

Okay, all right. Thank you.

Operator

Operator

[Operator Instructions]. The next question is from Eun Yang with Jefferies.

Eun Yang

Analyst · Jefferies

Hi, thanks. I want to ask you, if I heard it correctly again, Jonathan, when you talked about a plan to Phase II for the insulin program. You mentioned that you are actually -- you guys are talking to potential partners as well in terms of the design of the trial? Does that mean that you would get an input from a potential partner and partner would be involved in the running the clinical trials as well?

Jonathan Lim

Analyst · Jefferies

Eun, Halozyme will be running the Phase II program, but we have mentioned previously that we are open to partnerships. And so, we are exploring both pads in parallel. But we are fully committed to taking one of the insulin programs forward all the way through to approval and commercialization.

Eun Yang

Analyst · Jefferies

Okay. And then the second question is kind of more general. Now that, to inhale the insulin potentially the pretty much here wiped out from the marketplace. Are you seeing more interests in your program or is that kind of not so much of changed in terms of partnership opportunities?

Jonathan Lim

Analyst · Jefferies

I will say Halozyme seems to be in the right place at the right time especially with this particular program. So, the interest level has been very high and I would say that the inhaled insulin situation has been one contributor to that but more importantly the power of the PH20 combination with both insulins has been very compelling and the Phase I data have really opened eyes amongst the care well community as well as amongst potential partnership.

Eun Yang

Analyst · Jefferies

Okay thanks.

Operator

Operator

There are no further questions at this time. I will now like to turn the call over to Jonathan Lim for closing remarks.

Jonathan Lim

Analyst · Jefferies

Okay. Well, with five proprietary programs and three partnered programs all of which are part of our blockbuster franchises in metabolism, oncology, dermatology, and drug delivery. Halozyme truly has a unique and exciting business strategy that aims to leverage the core technology and a knowledge base at the company. We are not just developing one or two products as is the case with many biotech companies. Instead Halozyme intends to leverage its core technology and matrix expertise across the number of therapeutic categories that represent large established markets and substantial commercial opportunity. We believe this strategy will provide multiple shots on goal that can drive significant value for our shareholders. We look forward to updating you again soon on our progress and remember to mark you calendars for Investor Research Day on October 8, which will be in New York. Again, thank you for your support, your interest in Halozyme and for your participation in today’s call.

Operator

Operator

Thank you. This concludes today’s Halozyme's second quarter 2008 pipeline update. You may now disconnect.