Halozyme Therapeutics Inc (HALO) 2010 Q4 法說會逐字稿

Greetings and welcome to the Halozyme Therapeutics fourth-quarter and 2010 financial results conference call.

At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions). As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Robert Uhl, Senior Director Investor Relations for Halozyme Therapeutics. Thank you. Mr. Uhl, you may begin.

Thank you Rob. Thanks also to everyone for participating in today's call. I'm Robert Uhl, Senior Director of Investor Relations at Halozyme. Joining me on the call today from Halozyme are Gregory Frost, President and Chief Executive Officer, and Kurt Gustafson, Chief Financial Officer.

This morning, Halozyme released 2010 fourth-quarter and full-year 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 send an e-mail to me at ruhl@Halozyme.com. This call is also being broadcast live over the Internet at www.Halozyme.com, and a replay will be available on the Company's website for the next seven 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 a Safe Harbor for forward-looking statements. All statements made during this conference call that are not statements of historical fact 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 in the Company's business are described in our filings with the Securities and Exchange Commission, as well as in our news releases. The Company's actual results may differ materially from those expressed in or indicated by such forward-looking statements.

With that, I would like to turn the call over to Greg Frost, Halozyme's President and CEO.

Thank you Robert. Good morning everyone. Thank you for joining us today.

I'll be providing an update on the status of our key proprietary product development programs and our alliance programs with Roche and Baxter. Also on the call today, Kurt Gustafson, our CFO, will provide the highlights of our financial results for the quarter.

2011 is already off to a fast start, and we believe this is going to be a very important year of progress at Halozyme. We are confident that our strategic focus of resources towards our alliance partnerships and our advanced proprietary programs optimally position the Company to capture these two avenues for value creation. To accomplish this, we've reduced some of our activities in basic discovery research in order to drive our three unique advanced product opportunities through key clinical inflection points all in parallel.

Over the next 12 months, we will be conducting clinical studies for each of our three distinct proprietary programs -- Ultrafast Insulin, PEGPH20 and HTI-501. These studies will establish the key clinical attributes of these exciting product opportunities. Importantly, we secure the financial resources necessary to fund these trials through these upcoming value inflection points.

So let me bring you up to date on Halozyme's Ultrafast Insulin program. Since our last conference call, Halozyme's Ultrafast Insulin program has continued to progress very well completion of enrollment for our two Phase II treatment studies, one in Type I diabetes patients the other in patients with Type II diabetes. Each study compares Aspart PH-20 and Lispro PH-20 with a standard of care active comparator, Lispro. As a reminder, Aspart is the generic name for Novolog and Lispro is the generic name for Humalog. End points in these trials will include clinically and commercially relevant benefits such as improved glycemic control, A1c, reduced hypoglycemia and reduced weight gain. We expect these trials to be completed with results available to us internally during the third quarter of this year.

With the increasing growth of the insulin pump market and the sophisticated early adopters of new insulin therapies, we also decided to initiate clinical studies in Type I patients that receive their insulin via pumps. This double-blind crossover pump study with approximately 36 Type I patient tests subcutaneous continuous infusions of either insulin analogues alone or insulin analogues with rHuPH20 for three days each. The primary endpoint compares insulin exposure following bolus infusions of insulin delivered by a pump over three days. Additional PK and glucodynamic measures include Cmax, Tmax, glucose infusion rates, and responses to standard meal challenges, as well as an area into the curve at specified time intervals, but importantly a close evaluation of the safety and local tolerability of insulin analogues with and without rHuPH20 will also be performed.

So we are very excited to announce that results from the first stage of this clinical study have been selected for oral presentation at the late-breaking clinical trials session at the American Association of Clinical Endocrinology Annual Meeting and Congress coming up here next month in San Diego on April 14. We have always felt that the fast-in/fast-out profile of insulins with rHuPH20 would be ideal for use in insulin pumps. Previous studies have demonstrated the co-injection of rHuPH20 with an insulin analog, resulted in a more physiologic fast-in/fast-out profile that enhanced the mealtime glycemic control for each analog.

Numerous key opinion leaders who treat diabetes patients and others in the insulin space have inquired about either the safety or utility of our technology in insulin pumps, so we are very excited to have these clinical studies underway. Collectively, we will have a truly comprehensive data package consisting of ten Ultrafast Insulin clinical trials once the pump studies and two Analog-PH20 treatment studies are completed this year. We feel confident that the results from these studies will answer the right questions and be sufficient for us to make the best portfolio and partnering decisions.

The overarching goal for our Ultrafast Insulin program is to develop best-in-class mealtime insulin product compared to the currently prescribed analog products that participate in the growing 4 billion prandial or mealtime insulin market. With Halozyme's more rapidly absorbed faster acting insulin, we seek to demonstrate significant improvement relative to existing treatments such as improved glycemic control, less hypoglycemia and less weight gain, to make it easier for patients to control their disease.

Now let's switch to our PEGPH20 program and its potential in the treatment of solid tumors. PEGPH20 represents an entirely new approach to the treatment of solid tumors. Many solid tumors, including breast, prostate, pancreas, gastric and lung, accumulate an extracellular matrix polysaccharide known as hyaluronan, that protects the tumor from anticancer therapy. PEGPH20 PEGylated version of Halozyme's proprietary rHuPH20 enzyme designed for systemic administration remodels the tumor stroma of HA producing solid tumors, thus making these tumors more susceptible to anticancer treatments.

Now, roughly 20% to 30% of solid tumors accumulate HA. In the case of pancreatic ductal adenocarcinoma, our research has found that the majority of these tumors accumulate HA, which is why we targeted this specific cancer for a Phase II trial. With the ubiquitously poor outcomes for this cancer, we feel that the biology has directed us to a disease with tremendous unmet medical need.

And our Phase I clinical trials with PEGPH20 are collectively designed to identify the recommended dose and frequency to favorably modify the tumor microenvironment. These data will enable trials with PEGPH20 as a single agent and in combination with other therapies. Additional data from the preclinical pharmacology with other agents will be presented at AACR this year. But based upon what we've seen so far, we're planning to conduct a randomized Phase II clinical trial in patients with pancreatic cancer that will compare gemcitabine alone and gemcitabine with PEGPH20. We also expect this trial will start in the second half of this year with the help of some of the top clinical investigators in pancreatic cancer.

But unlike our other platforms that target sugar components of the matrix, HTI-501 is our first conditionally active recombinant human capsaicin enzyme that degrades collagen. There are numerous collagen-based conditions such as keloids, hypertrophic scars, and cellulite, that are in adequately served by existing treatments where a product such as HTI-501 may prove useful. We now have the ability to produce this enzyme in high-expression cell banks and are manufacturing HTI-501 at clinical scale and have completed all of our safety assessments for first-in-human dosing. Our regulatory submission is on track, we are filing this month, and we're moving forward to conduct a proof of concept clinical trial ex-US in cellulite, which should allow first-patient dosing in the third quarter of 2011 and provide clinical readouts to us on the safety and clinical activity before the end of the year. We'll update you with additional information about the program as we get closer to the start of the study.

Now let's talk briefly about HYLENEX. In early 2011, Halozyme and Baxter reached an agreement that resulted in the return of worldwide market rights for HYLENEX to Halozyme. We're driving to complete the transition agreements with Baxter and will be providing more information on our overall strategy for HYLENEX at that time. Resolution of the manufacturing issue discovered in a small number of vials during a routine inspection is a high priority for Halozyme. Halozyme identified the root cause, proposed a corrective action to FDA and is working with the agency to gather confirmatory data. We are projecting HYLENEX manufacturing will resume later this year, resulting in a 2011 product reintroduction.

So let's move over to our partnership alliances with Baxter and Roche. HyQ, which consists of immune globulin in our rHuPH20 enzyme, completed its Phase III registration study at the end of last year. Baxter has stated that it is moving forward to file its BLA for the product in the treatment of primary immunodeficiency during the second half of this year and is preparing for an introduction in 2012. Preliminary results from the Phase III HyQ study have shown that patients could receive their intravenous dose of immunoglobulin as a subcutaneous injection facilitated by rHuPH20 at the same frequency and volume using a single injection site as their previous IV dose.

The ease of subcutaneous administration of HyQ may allow patients to benefit from convenience of self administration of their immunoglobulin treatment in the home setting. HyQ may have advantages compared to currently available subcutaneous immunoglobulin products that must be dosed once a week through multiple needles and at a higher dose to compensate for their lower bioavailability. The annual global immunoglobulin market is approaching nearly 6 billion.

The Halozyme-Roche alliance is also moving forward. The Phase III registration trial for a subcutaneous formulation of Herceptin with rHuPH20 and the treatment of HER-2 positive breast cancer which began in October 2009 completed enrollment of 595 patients in December of last year. Roche has stated during a recent presentation to financial analysts that it plans to provide some results from the Phase III trial by the end of 2011 and said that its BLA is on track for filing in the EU in 2012.

Subcutaneous MabThera, also known as rituximab, began its Phase III registration trial in February 2011. MabThera is approved for the treatment of non-Hodgkin's lymphoma and chronic capsaicin leukemia. As in the case of subcutaneous Herceptin, the formulation of MabThera for subcutaneous administration contains our rHuPH20 enzyme which acts to facilitate absorption of the monoclonal antibody.

So far, clinical studies have demonstrated that more rapid administration times can be achieved with a subcutaneous version of these products. For example, in the case of Herceptin, the currently approved IV regimens take 30 to 90 minutes, but subcutaneous delivery with our rHuPH20 enzyme takes less than five minutes. IV administration of MabThera may require three to five hours for many patients, but data from the Phase I trial results presented this past December at ASH demonstrated an average administration time for subcutaneous formulation of less than ten minutes. So Roche has announced also its development of a ready-to-use device that would be capable of administering Herceptin subcutaneously in less than five minutes.

Subcutaneous administration of Herceptin and rHuPH20 with a proprietary device holds the promise of a five-minute administration, which could be a significant timesaver for patients. Instead of that long IV infusion and the medical resources that it involves, patients will be able to choose the convenience of a prefilled device to deliver their Herceptin treatment sub-Q. Use of the device would not require any mixing or reconstitution of the drug by a pharmacist, which represents a potential savings of healthcare resources. So these are the latest updates on our proprietary product programs in our development partnerships.

So now I'll turn the call over to Kurt Gustafson for his financial commentary.

Thank you Greg. Good morning everyone.

The net loss for the fourth quarter of 2010 was $16.9 million, or $0.17 per share, compared with a net loss for the fourth quarter of 2009 of $12.7 million, or $0.14 per share. For the year ended December 31, we reported a net loss of $53.2 million, or $0.56 per share, compared to a net loss of $58.4 million, or $0.67 per share, for 2009.

Revenue for the fourth quarter of 2010 was $3.6 million compared to $6.4 million for the fourth quarter of 2009. This reduction is a result of the fact that we received a milestone payment from Roche in the fourth quarter of 2009, and we didn't have that same situation in Q4 2010. The revenue in 2010 is mostly related to work that we do for Roche and Baxter that's reimbursed under our agreement.

Research and development expenses for the fourth quarter of 2010 were $15.9 million compared with $14.9 million for the fourth quarter of 2009. This increase is primarily driven by manufacturing.

SG&A costs for the fourth quarter of 2010 were $4.6 million, compared to $4.1 million last year. We ended the fourth quarter with a cash balance of approximately $83 million. Our net cash burn for the fourth quarter of 2010 was $6.6 million and for the total year was $44 million. This excludes the proceeds from the September financing.

For 2011, we are forecasting a net cash burn of $47 million to $52 million, a small increase from 2010. Total operating expenses should rise slightly year-over-year due to increased costs associated with the additional clinical trial activity.

With that, I'll turn the call back over to Greg.

Thank you, Kurt. I am pleased with the progress Halozyme continues to make in advancing both our proprietary programs and our partnerships. Now let's open it up for questions. Operator?

(Operator Instructions). Jonathan Aschoff, Brean Murray.

Thank you. Good morning guys. I had a few questions, just the first couple and the last two are a bit nitpicky on financials. I was wondering if you could help us understand the rate of progress with Actemra or is Roche essentially going to take a long pause with that? The second one was what can you tell us about this patent opposition in Europe?

Sure. So let's start with the Actemra set. So first, as you mentioned, Roche conducted a Phase I clinical trial with a combination of Actemra and our PH-20 enzyme. So they presented those results last Friday at the ASCPT meeting in Dallas, which obviously identified that Actemra is the third target. So the results from that identified that the combination of Actemra and PH-20 increase the AUC, have the higher Cmax and overall PK results that you'd expect. A range of doses were looked at which would approach up to a monthly dose. However, for the moment right now, Roche has decided to advance their smaller-volume, higher-frequency product to go through forward.

So I think from the standpoint of the timing on that, we don't have I think good clarity as far as how Roche is looking at the lifecycle management of the higher frequency versus going towards a monthly in this area. But it's something that I think we would expect to see in the not-too-distant future some more information.

So the second question that you had regarding Europe, this is something which is not unusual from that standpoint. If you take a look at the patent opposition that we had, essentially we have claims which were a little bit broader than what we had, for example, in the US, but all of the issues that we've looked at from the standpoint of prosecution that were raised in the opposition itself were all raised actually in the US through that evaluation. So, we anticipate from that it's a relatively long period of time that goes through for these oppositions just from the overall process itself but we are very confident that we will end up with claims very similar to what we have in the US.

Okay. Then is the two little nitpicky ones. All of the revenue now until things change -- I'm sorry, all of the sales is 100% Cumulase, correct?

Going forward, I would say the three things that would be hitting specifically the sales line are obviously, as you mentioned, sales Cumulase, HYLENEX was booked there, so if you go back and take a look at for example 2010, there were -- so HYLENEX would be included in that as well as sales of API to partners also show up in that line.

Okay. Then would -- if you could help us a little bit. Would the R&D for 2011 be somewhere between 2010 and four times the fourth Q of 2010? Can you say something like that?

I didn't bring a calculator with me here to (multiple speakers)

Somewhere between $52 million and $64 million.

Here's how I would characterize it. We're telling folks obviously for our guidance that total operating expenses is increasing slightly. I would apply that same guidance to the R&D line.

Fair enough. Thank you very much.

Andrew Vaino, ROTH Capital.

Thanks for taking the question. I notice that Roche now has rights to eight biologics instead of the previous 12 or 13. When did this change occur?

Do you want to cover that Kurt?

Sure. So if you go back to the original Roche contract, they had originally 13 different targets that they had access to. Five of those were these option targets where they just, they were paying maintenance fees to keep these slots open. There was no targets that were -- there was no name targets, if you will, behind those. Last year in December, they did not make the maintenance payments for those slots, and then therefore they lost those slots. We speculate, based on what Roche is going through, a rationalization of their pipeline, cost cutting, they just decided that this wasn't part of the budget money they wanted to spend. But they still have eight out of the 13 original targets are still available to them.

Of those eight, they've declared five so far, if I'm correct?

Five are currently exclusive, that's correct.

So they can still choose three more, is that correct?

That's correct.

Any possible insight -- I know it's not entirely your decision, but insight on when we could get data on the -- final data on the HyQ Phase III study?

Andrew, I'd love to be able to tell you but I just can't give you that answer until Baxter declares what it's going to be. We speculate that it will be at some meeting this year, but we just don't know until Baxter makes that statement.

Great, thank you.

(Operator Instructions). Chris Holterhoff, Oppenheimer.

Thanks for taking the question. My first question is on expectations for revenue under collaborative agreements. I know you don't really give guidance here. Just looking at your guidance for operating expenses and cash burn in 2011, it seems to imply that your expectations are for 2011 revenue to be in line with what we saw in 2010 or maybe even a bit higher. I'm just wondering if that's the correct way to think about things.

Chris, I'm not sure -- I really don't want to give any specific guidance on that revenue line. For the most part, that revenue line relates to reimbursements that we get under -- from these partnership agreements. So, if you think about our P&L, it's really just a gross-up. We see operating expenses that are reimbursed by our partners. The second thing that you see there is the amortization of the upfront payments that we got from these partnerships. So I guess I describe it that way because, as you look at that line item, the delta of it moving around really doesn't have (technical difficulty) impact on our cash position because either it's cash that we are spending that is reimbursed or it represents revenue that's coming in that was cash that was given to us a couple of years ago. So, I'm not going to give you any specific guidance there, but just kind of try to give you some color of how to think about that.

Fair enough, that's helpful. Then just maybe one more question for Kurt. Under the agreement with Baxter for HyQ, I think Halozyme is eligible for about $37 million more in additional milestone payments. And just wondering if you expect to receive a payment upon approval of HyQ in addition to a milestone payment on the filing of the BLA.

Yes, there is a milestone upon filing. Then what was your other question? Was there a --

In addition to a milestone payment if and when HyQ is approved in 2012.

I believe the milestone is on first commercial sale. Yes, that's right. So not approval, but first sale. Then there's various milestones associated with certain sales tier levels.

Thanks. Just last thing, maybe a more general question. The Company certainly has a lot of partnering -- potential partnering opportunities on the table here. I'm just wondering, with the new management team in place, how you think about prioritizing the different programs?

I think the first point I can make is that with the flying formation I think historically going through that we have a very strong lead in Bill Daley from the business developer standpoint. He has I think picked up both prior leads and new ones I think very efficiently. So we are not really going through and certainly not micromanaging that process, but what I can say is if you just take a look at the need from the standpoint in all of these areas where you have to have the data to support what you're looking for, you have to have someone that wants it, and you have to have someone that can close a deal, I feel very good that we have all of the ingredients there. So if we take a look between elements of enhanced technology partnerships, proprietary product partnerships, and then even other assets that we have de-prioritized, I think you'll find that we have active mobility in all of those going through. But this is something which, as you know on these sorts of things, you don't go through and talk about when the deal is going to be done until the 8-K is filed.

Right. Great, thanks a lot. Thanks for the added color.

John Sonnier, William Blair.

Good morning. Thanks for taking the question. I apologize if I missed this, but can you tell us I guess more specifically what we're going to see at this upcoming endo meeting?

Sure. So this was a nice piece going through that, as you know, this is a multistage study that we are doing with insulin pumps. I personally -- this is one of the aspects of the insulin program I am most excited about. And so this effectively is an analysis going through of the first cut of series of patients going through. The important things in insulin pumps, obviously we've had questions of both. Do you get the same pharmacokinetic profile with continuous subcutaneous infusion, with boluses going in? Then secondly is this safe and tolerable? So we've actually had some work to do, some very close analysis on that as well. So this will be an oral presentation at [ASTEM] in San Diego next month.

Is there going to be an abstract ahead? If so, when does that come out? I guess if not, is there anything you can tell us about how big, how many patients the analysis will include?

I believe the abstracts that went through was just on the first eight patients going through. And I think it's an 18 stage on one and 18 on the other.

Okay. Then just one quick question on HYLENEX. What is the current thinking on how you handle that product once it kind of gets back on track? Is it your intention to hire distributor reps and keep it on your own, or do you go to a hospital salesforce and just try to relicense it?

Yes, all of these elements are things that we are looking at. But what I'd prefer to do I think -- we're still in the process of just finalizing the transition agreements with Baxter, and so we're going to go through and get those squared off before we talk about overall strategy at this point.

Thanks a lot.

Eun Yang, Jefferies & Co.

Thanks very much. The Herceptin sub-Q data coming out by end of this year, are we expecting a secondary outcome measurement as well for more clinically meaningful measurement?

Yes, I think what you'd expect from the standpoint of what Roche has articulated is that they're going to have the clinical data set on the primary endpoints going through on this, and so you might expect to see topline data coming out. (inaudible) give you a lot more color about how they plan to go through and present that, so all I know is just on the topline data is what we should anticipate at this point.

So maybe not on like the response rate and PFS and overall survivor data (inaudible)?

Yes, great question. So the primary endpoint, the co-primaries which you have, one which is pathologic complete response rate, this is a -- has a new adjuvant run-in design on it. So that particular component you'll know and that's really the key, the front line from an efficacy component to see how you're doing, and then you have the pharmacokinetic and tolerability elements there.

Now, in terms of the US filing strategy, has Roche indicated which route they may take?

With regards to Herceptin sub-Q?

Yes.

Yes, so I think what I would take a look at is that it's not yet finalized discussions with FDA regarding the potential US regulatory submission, so they're going to be following that up at a later point. That's effectively from the standpoint is that they've got a very aggressive filing strategy for OUS going through. So they are still working with the US on the standpoint of integration there.

But then the last question is in the event that the FDA requires a BLA submission instead of a SBLA, then do you think the current study, the Phase III study, would that be sufficient for filing for BLA?

You know, there's a lot of complexities that I could go into on it, Eun, to get into that from a regulatory standpoint, and trial designs and other elements going through. But I think the answer is until you've got good clarity from the agency on it, it's kind of speculation.

That's fair. Thank you.

[Chris Gessen], UBS.

To follow-up on Eun, the Herceptin especially [SE] market, there were some comments or concerns about I guess the embedded IV infrastructure and incentives for docs here in the US. Could you kind of discuss even from MabThera and Herceptin what the market size, revenue size is globally? How much of that is in the US? Could you clarify what maybe Roche has said, not said, and how you guys look at the obstacles if they are greater here in the US?

I think what I would do is just let Kurt spent some time in here to talk about it. I think the global market (inaudible) on Herceptin maybe just a break in there is probably a good way to start.

So let's call Herceptin worldwide sales somewhere between $5 billion and $6 million. The breakdown that I have seen is close to 70% of those sales are outside the United States, so ex-US market is the bigger market. So those issues that you're talking about in the US don't exist for 70% of that sales volume.

But do they exist here in the US? If so, is there a strategy to overcome?

I think -- well, I would say two things. One is that there are some incentives for doctors who want to see their patients and they make money delivering chemotherapy agents in the office. This still is a chemotherapy agent that could be administered in the doctor's office, so from that standpoint, doctors could still make their money on this product.

What I want to be careful about saying is are there strategies to deal with that? The collaboration that we have with Roche is not one where we discuss marketing, the marketing aspects of what they're going to do. So I just don't have insight into Roche's specific marketing plans in the US, and sp it's probably not wise for me to go speculate on what they specifically plan to do.

But the 70% suggests to me that there are a number of reasons why they would more actively pursue approval in marketing first outside of the US. That's helpful. Okay. On the PEG program, you may have said this in the past, but do you expect to kind of run it the way you are on the insulin program? In other words, you take it along on your own, absorbing the costs, getting it to a point where you can realize the most value? If so, the other thing that is unique here, I believe, is that you've run some of these studies with just the PEG-PH, and then you've run it with another drug. Is there any thought that you may do this on your own and without the assistance of another drug?

Well, I think the data-driven decisions for the first -- for the most part. So right now, we are going through and we're running this program with really a key objective in mind. That is to optimize the dose and the frequency for getting into a randomized Phase II. So, we will be doing -- we've looked at a number of ISTs, investigator sponsored trials, with some other exploratory indications, but the one that we are really focused on is pancreatic ductal adenocarcinoma. This is looking at really clean science, randomized Phase II, gemcitabine, gemcitabine with PEGPH20. You can't go front-line with a new agent from that standpoint.

What we've seen to date with combinations with gemcitabine in pharmacology models makes us very confident that that's the right answer. So if you then go from there and say, well, okay, we are going to get the randomized Phase II off and running this year and we're going to clear that out in 2012, what are you going to do from there?

Well, one of the nice things about pancreatic cancer is that everyone else has failed, so there isn't a lot of competition. But the second piece is there is so much room for improvement because the median survival is still sitting between six and eight months with the approved therapy. So, if we go through and we are successful with pancreatic cancer, it would be foolish for us not to go through and partner up with a very strong organization, ex-US from the standpoint of capitalizing upon that, to be able to drive more indications, because frankly we have the diagnostics that can let us essentially, we believe, identify patients likely to respond in a lot of other types of malignancies. In pancreatic cancer, it's nearly 90% of them, so you don't really need it. So in that case, certainly we're going to run this through the value inflection point, which is a very well-controlled study. Once we get from there, it really will be -- it's going to be data-driven. You sit down you look at the MPV and how to go through and capture it.

I'm sorry because I just don't know this space as far as the embedded players so far. Are you limiting yourself in the testing you're doing to one partner, one drug combination? (multiple speakers)

No. Remember, gemcitabine -- we have the opportunity here which is this agent, frankly, we are looking at it -- the BLA that you'd be looking at, this is going to be the agent itself, just like it would be for avastin or anything else, but they are typically approved for use in combination with another agent. But we are not going to be formulating them together or doing things of that nature. So that's where I think you'd say territorial or geographic partnerships make a lot of sense here.

If I may, just one last one on the diabetes front. You did say rather specifically that result would be available to the Company --

Yes.

-- Sometime in third quarter. I assume that would mean to anybody on the NDA or someone who's working with you who is a potential partner to them as well?

That's correct.

As far as not making that distinction, is that because you don't have a forum to release that in, or --?

Yes, it's just from an embargo standpoint, our team is, from the presentation standpoint, you need to be careful from the standpoint of whether or not we go through and you have topline data going through versus presenting it in a good scientific congress. It's usually our preference to deliver that data out in an appropriate forum.

So given all you said about the ten studies being completed at some point in the near future, the headway you've made, the consistency, the pump, etc., all these options, what could we expect to kind of see as landmark announcements in progress on a general timing basis?

So I think, if you think about where the team is moving right now, this particular year, the first half of the year, these types of studies that are being done in insulin pumps are very important. So what you'll see is obviously there's going to be the first set of data unveiled at ACE. Then obviously we have the ADAs in San Diego this year as well in June. So we're going to be working along with all of those. Obviously, our big study is the 110 Type I and 110 Type II patients. That doesn't wrap up until the third quarter. So obviously that data set isn't going to be talked about at ADA. But effectively with those studies complete, you are really looking at a complete package at that point. Ten studies all squared away essentially gives us everything we need to do. Our portfolio decisions and partnering strategy decision sets from there.

So a Christmas Eve deadline on the auction? Just kidding.

Well, if we go through it again on those, I -- you make data-driven decisions on the portfolio. We are in no rush to go through from the standpoint of timing on any of these. We'll get the right things working out from it.

Thank you for all the color.

Dr. Frost, there are no further questions at this time. I would like to turn the floor back over to you for closing comments.

Thank you.

So 2011 looks like it's going to be an important year of clinical advancement for Halozyme. Our Ultrafast Insulin program will complete three clinical studies, including three times daily treatment studies in Type I and Type II diabetes patients, and an insulin pump study in Type I patients.

Halozyme expanded the PEGPH20 cancer program with two ongoing Phase I clinical trials and is continuing plans underway to initiate the randomized Phase II trial in pancreatic cancer during the second half of this year. Our HTI-501 program is also expected to enter a proof of concept human study during the third quarter as well. So we are moving forward with what we believe will be also a resolution for the HYLENEX manufacturing problem and if additional data we're gathering provides the answers that will be satisfactory to the agency, we plan to have the product back on the market by the end of this year.

So Baxter's Phase III registration study for subcutaneous HyQ with rHuPH20 has also been completed, and they plan to file their BLA during the second half of this year. Patient enrollment for Roche's Phase III registration trial for Herceptin subcutaneous has been completed, and the Phase III for MabThera subcutaneous is underway. Based on Roche's statements, we expect to see data from the Phase III Herceptin sub-Q trial by the end of this year, and both products are expected to file in the EU during 2012. So, I believe late-stage clinical and regulatory activity is paving the way for three product introductions by our partners -- HyQ, Herceptin SC, and MabThera -- during 2012 and 2013. We are fortunate to have numerous product opportunities in various stages of development, and it looks like we have another busy year ahead of us. So we look forward to updating you again on our progress. Next week, we'll be presenting at Barclays Global Healthcare Conference in Miami on Wednesday, March 16, and I hope to see some of you there. Again, thank you for your interest in Halozyme, for your participation in today's call. Take care everyone.

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.