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Halozyme Therapeutics, Inc. (NASDAQ:HALO)

Q4 2008 Earnings Call Transcript

March 13, 2009 11:00 am ET

Executives

Robert Uhl – Senior Director, IR

Jonathan Lim – President and CEO

David Ramsay – VP and CFO

Analysts

Kevin DeGeeter

Eun Yang

Chris Geston

Matt Osborne

Andrew Vaino

Stephen Harris

Operator

Welcome to the Halozyme 2008 fourth quarter and full year financial results and pipeline update conference call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we will hold a question-and-answer session. (Operator instructions) As a reminder, this conference call is being recorded today, March 13, 2009. I would now like to turn the call over to Robert Uhl. Please go ahead.

Robert Uhl

Thank you, 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; and David Ramsay, Chief Financial Officer. Additional members of the Halozyme management team will also be available to address your questions during the Q&A portion of the call.

This morning Halozyme released 2008 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 call Alex Schlam [ph] at 858-704-8288. This call is also being web cast live over the Internet at www.halozyme.com and a replay 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 make 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 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 news 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 Jonathan Lim, President and CEO.

Jonathan Lim

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

On the call today, I will briefly review our major accomplishments in 2008, update the status of our key development programs, and provide an overview of our business plan, and how each program fits within that plan.

Also on the called today David Ramsay, our CFO, will provide the highlights of our financial results and some thoughts about the current year. I'm pleased with the tremendous progress Halozyme has made in 2008 and so far in 2009. As a result of this forward momentum; Halo’s fundamentals have been stronger than they have ever been since founding just over a decade ago.

During the fourth quarter of 2008, four of our programs made important advances in clinical development as two programs entered Phase I, one entered Phase 2, and one began a Phase 3 clinical trial. Specifically, these four programs are bisphosphonate PH20, which began a face on clinical trial in osteoporosis patients; Roche, which initiated its first Phase I clinical trial for one of its biologics with PH20, and has subsequently initiated an additional Phase I clinical trial in 2009; insulin PH20, which advanced to a Phase 2 clinical trial in type 1 diabetic patients; and GAMMAGARD LIQUID with PH20 in a development alliance with Baxter BioScience, began a Phase 3 registration study in patients with primary immunodeficiency.

PEG PH20 for the treatment of solid tumors made strong progress in preclinical studies in 2008 that are paving the way for it to begin patient dosing in a Phase I cancer study soon.

We firmly believe that the development milestones that I just described along with the development activities related to other proprietary and partnered product candidates are significantly raising the intrinsic value of Halozyme. So, one of the important value creators is our proprietary product development program. So, Halozyme continues to pursue in parallel four multibillion-dollar franchise opportunities in the areas of endocrinology, oncology, dermatology and drug delivery.

Within these four therapeutic areas, we have proprietary product development programs, where our goal is to identify innovative new drugs with highly differentiated value-added characteristics that will allow them to be either best-in-class or first-in-class products with large commercial sales potential.

All of our proprietary programs utilize our unique enzyme technology that permits a temporary alteration of the extra cellular matrix, which is the area outside of the cell, in order to permit the delivery of a pharmaceutical or biologic in a unique way. We maintain worldwide rights to our proprietary programs and may continue to pursue development of each of these on our own or choose to enter a development partnership of licensing arrangement with another company.

Within endocrinology, we have insulin PH20 and bisphosphonate PH20. In the oncology franchise, we have PEG PH20 and Chemophase, and in the derm franchise we have HTI-501.

So now I'm going to dig into the individual proprietary programs starting with insulin PH20. I am pleased to announce today that the abstract for our ongoing Phase 2 insulin study has been accepted for a Poster Presentation on Saturday, June 6 at the American Diabetes Association meeting in New Orleans. For this Phase 2 study, we enrolled type 1 diabetic patients, and we believe we will be able to demonstrate that a gold standard insulin analogue treatment, such as Humalog, administered at a therapeutic dose along with our enzyme, will show a superior profile relative to the analog alone.

We designed this Phase 2 study to compare glycemic control of a standardized liquid meal challenge and insulin pharmacokinetics or PK after administration of each of four dosage regimens. Humulin R with and without PH20 and Humalog with and without PH20. The combination doses of insulin plus enzyme are co-mixed and administered to the patients as a single injection. This crossover design single blind, open label, liquid meal steady collects data on at least 20 patients who will complete the trial.

Each study drug is injected subcutaneously into the abdomen immediately prior to ingestion of the liquid meal. The primary endpoint in the study is area under the curve or AUC during the first 60 minutes after the injection of the test drug. We believe that the insulin analog plus PH20 enzyme combination should result in significantly greater AUC during this early time period relative to the analog alone. This faster absorption of insulin when administered with our PH20 enzyme means insulin can potentially produce its therapeutic effects more rapidly. Along with faster absorption and onset of effect, which more closely resemble mealtime insulin release in a healthy person, we should also observe a faster offset. So that faster onset and more rapid offset should translate into tangible patient benefits, such as less hypoglycemia, better glycemic control, and possibly less weight gain.

We submitted our ADA abstract early this year, so it includes only a handful of patients and limited data from the trial. Our poster at ADA will be more complete than the abstract, and will contain a significant amount of new info. But due to timing and logistical issues, the poster most likely will be partial dataset. We are planning to present the full dataset of the Phase 2 results at the EASD in Europe in September.

Two additional insulin clinical studies are also under way, a Phase 1 dose ranging PK and glucodynamic safety and tolerability study began during the fourth quarter of last year, and the enrolment of 40 subjects is proceeding according to plan.

The second study, which is an intra-patient variability study, just dosed the first of 18 subjects earlier this week. This trial will compare insulin PK measures in each subject for two doses of insulin analog alone, analog with PH20 and regular insulin with PH20. The purpose of this variability study is to evaluate and quantify whether or not the presence of PH20 produces a more consistent PK profile relative to the PK variance produced by the insulin analog alone.

In addition to the ongoing insulin clinical trials, a scientific paper describing the results of our initial Phase I study presented at the ADA in June of last year has been accepted for publication by a peer-review Journal. We anticipate publication of the article this summer. As you can tell, our insulin program is moving forward at full speed with the broad array of clinical investigations underway, and a great deal of progress being made.

Bisphosphonate PH20 is the other program within our endocrinology franchise. This is well into the Phase 1 dose ranging safety and tolerability study, which began in the fourth quarter of last year. The recruitment and dosing of additional cohorts has proceeded exactly on plan, and we are encouraged by this progress. In fact, this is an open label study, and based on what we have seen so far, we believe that this program is exceeding our expectations. We anticipate announcing the results of this trial by the end of the year.

So, now let us shift over to our oncology programs. PEG PH20, which is the pegylated version of our hyaluronidase enzyme, is getting closer to the start of its first Phase I clinical study. This trial will be a range finding, repeat dose PK and pharmacodynamic safety trial of PEG PH20 administered intravenously as a single agent in cancer patients with refractory solid tumors. The primary outcome will be to determine the recommended dose for Phase 2, and to evaluate the safety and tolerability of the agent. Results from this first Phase I study should be available by the middle of next year.

Hyaluronin or HA is a dominant component of the tumor micro environment for many subsets of solid tumors. This is why we believe that our hyaluronidase enzyme could eventually play an important role in the treatment of solid tumors. In fact, solid tumor types known to produce HA include a broad variety of tumor types, such as prostate, ovarian, breast, colon, pancreas, and gastric.

Based on our tests in mouse tumor models that produce HA, the removal of HA with our novel PEG PH20 enzyme occurs in a dose-dependent manner, which results in a meaningful reduction in tumor size, and prolonged time to progression compared to controls. HA removal also leads to significant reductions in tumor interstitial fluid pressure or IFP, and tumor diffusion-weighted MRI.

Many bladder tumor cell types also produce HA. Chemophase, our combination product for the treatment of superficial bladder cancer consists of PH20 and the antineoplastic agent, Mitomycin-C, administered intravesically or directly into the bladder. Chemophase continues in two ongoing clinical trials, which we expect to wrap up by the fourth quarter of this year.

We conducted a strategic assessment during the first quarter of 2009 of the resources required to advance our various programs. As a result of this process, we decided to reallocate certain resources previously budgeted for Chemophase projects to other high-priority, high-value programs, such as our insulin PH20 and PEG PH20 programs. We will finish the ongoing trials and the activities associated with Chemophase, but we will not be initiating new studies or committing new resources to the program at this time. We are currently exploring strategic alternatives that will allow the Chemophase program to advance its clinical development.

So, now I will speak briefly about our dermatology program. The key compound in our derm program is the human lysosomal enzyme, HTI 501 that degrades collagen. The protein only shows activity at a slightly acidic pH of 5 to 6, and does not remain active at normal physiologic pH of roughly 7.4. We believe HTI 501 may play a role in both medical and aesthetic dermatology applications such as cellulite, Dupuytren's contracture or scarring. We have been conducting numerous studies in various animals to learn more about the dosing, formulation, and characterization of this enzyme. Our preclinical investigations will continue through 2009.

So those are the latest updates on our proprietary product programs. Now let us turn our attention to the development partnerships.

As many of you are aware, Halozyme has three partnerships. Two of these involve our enhanced technology with Roche and Baxter BioScience, while the third partnership is with Baxter Medication Delivery for Hylenex, our FDA approved drug.

So first I'm going to give you an update on our Roche activities. So representing a small step for Roche but a giant leap for Halo, Roche entered the clinic this past December with its first biologic agent combined with PH20 directed against one of the four exclusive targets covered in our partnership.

Soon after, another clinical study began in January with another Roche biologic combined with PH20 directed against the second exclusive target. We anticipate that both of these Phase I studies should be completed this summer. Although, we are not permitted to say which biologics in the partnerships have entered the clinic, we are excited by these initial steps of clinical advancement, and believe the progress by Roche exemplifies its commitment to our technology.

As a result of these developments, we received $10.25 million from Roche. In addition, the start of a second Phase I clinical study in January triggered another milestone payment under the terms of the agreement. We cannot be precise in the timing for future milestones covered in the Roche agreement, but we expect additional milestone activity to occur in 2009.

As you may know, our other enhanced technology partnership is with Baxter BioScience. At the end of last year, Baxter began its pivotal Phase 3 clinical trial with GAMMAGARD LIQUID plus our enhanced technology as a monthly injection under the skin through a single site for the treatment of primary immunodeficiency or PID. This clinical study is a prospect of open label, non-controlled design that will be conducted in 10 to 20 centers in the US and Canada, and will enroll approximately 80 patients.

It will assess the prevention of acute serious bacterial infections and the PK parameters of subcu administration of GAMMAGARD LIQUID and PH20. Patients in this study will be treated for approximately one year, and results may be available by the end of 2010. This study represents Baxter BioScience’s commitment to innovation and to superior patient care, and Halozyme is pleased with the progress the two companies have made since the partnership began in September 2007.

Our remaining partnership is with Baxter Medication Delivery for Hylenex. In early January, we received payment of $5.5 million from Baxter, representing the final prepaid product payment due under the terms of the Hylenex agreement. The payment has been booked as deferred revenue. Hylenex has received FDA approval to increase the absorption and dispersion of other injected drugs, and for subcutaneous fluid administration.

Baxter Med Delivery plans to launch Hylenex into the pediatric hydration market during the fourth quarter of 2009, and continues to prepare its marketing capabilities to support the product. Baxter completed a pediatric hydration trial last year, and presented the results at two medical meetings in October 2008. In addition, a second pediatric hydration study is currently underway.

So based on my brief comments here, I'm sure that you could see that each of our partnered programs is moving forward and continuing to make steady progress.

Now I will turn the call over to David Ramsay for his financial commentary.

David Ramsay

Thank you, Jonathan, and good morning everyone. The net loss for the fourth quarter of 2008 was $16.8 million or $0.21 per share compared with a net loss for the fourth quarter of 2007 of $8.7 million or $0.11 per share.

For the year ended December 31, 2008, our net loss totaled $48.7 million or $0.61 per share compared to a net loss of $23.9 million or $0.32 per share for the full-year 2007. Revenue for the fourth quarter of 2008 was $3.1 million compared to $1.3 million for the fourth quarter of 2007. Revenues under collaborative agreements for the fourth quarter of 2008 were $2.8 million compared to $1.2 million for the fourth quarter of 2007. Revenues under collaborative agreements for the fourth quarter of 2008 primarily consisted of the amortization of upfront fees received from Baxter and Roche of $1.6 million and research and development reimbursements from Baxter and Roche of $1.2 million.

Total revenues for the year 2008 were $8.8 million compared to $3.8 million reported for 2007. Revenues under collaborative agreements for the year 2008, totaled $8.1 million compared to $3.2 million for 2007. Revenues under collaborative agreements in 2008 consisted primarily of the amortization of upfront fees received from Baxter and Roche of $3.4 million versus $1.9 million for 2007. Revenues under collaborative agreements also include R&D reimbursement revenue, primarily from Baxter and Roche, which jumped substantially to $4.7 million in 2008 compared to $1.3 million during the prior year, 2007.

R&D expenses for the fourth quarter of 2008 were $16.8 million compared with $7.3 million for the fourth quarter of 2007 primarily due to an increase in research and development headcount, spending on the PEG PH20, insulin PH20, and bisphosphonate PH20 pre-clinical and clinical program, and production costs associated with the manufacturing scale up of our (inaudible) PH20 and PEG PH20 enzymes.

During the fourth quarter, we incurred significant manufacturing expenses as we scaled up our capacity to provide materials to our partners Baxter and Roche. Approximately $2 million of this expense was originally planned for the first quarter of 2009, but was incurred ahead of plan in the fourth quarter.

Selling, general, and administrative expenses for the fourth quarter of 2008 were $3.2 million compared with $3.9 million for the comparable period in 2007 reflecting decreases in legal and professional fees, marketing research and employee recruiting expenses.

Our financial position remains very strong with cash and cash equivalents of $63.7 million as of December 31, 2008, compared with $97.7 million as of December 31, 2007, and $72.5 million as of September 30, 2008. Thus our cash burn for the fourth quarter was roughly $8.8 million, and for the full-year 2008 was about $34 million.

For the full-year 2009, we anticipate net cash burn of approximately $30 million to $35 million and that depends on the progress of various preclinical and clinical programs, the timing of our manufacturing scale up, and the achievement of various milestones under our existing collaborative agreements.

That concludes my remarks, and now I will turn call back over to John.

Jonathan Lim

Thank you, David. At this point, I would like to provide you with a summary listing of some of the important Halozyme milestones that we expect to occur during the remainder of 2009.

So, we plan to begin dosing of Phase I clinical trial for PEG PH20 as a single agent in cancer patients with refractory solid tumors in the second quarter of this year. For the insulin program, we will have multiple events this year, including presentation of interim Phase 2 data for insulin PH20 at the ADA meeting in June, followed by presentation of full dataset for Phase 2 insulin PH20 at the EASD meeting in September of 2009, initiation of the insulin PH20 with three times per day dosing in the fourth quarter of 2009, presenting top line data from the bisphosphonate PH20 Phase 1 clinical trial in the fourth quarter of this year, Hylenex launch by Baxter in pediatric hydration, also in the fourth quarter, and completion of enrolment by Baxter in the Phase 3 GAMMAGARD PH20 in the treatment of primary immunodeficiency during the fourth quarter of this year.

Additional milestones that we expect to occur this year, but where I can't give you precise timing are the initiation of additional Roche clinical trials plus milestone payments. At Halozyme, I believe we are making tremendous progress in advancing both our proprietary and partnership programs as rapidly as we can.

With that overview let us open it up for questions. Operator?

Question-and-Answer Session

Operator

And the first question comes from Kevin DeGeeter.

Kevin DeGeeter

Hi, good morning, guys.

Jonathan Lim

Hi, good morning.

Kevin DeGeeter

A couple of quick questions here. For the glucodynamic study and inter-patient variability study for insulin, should we eventually look for those being presented? Is that also EASD or is that some other form?

Jonathan Lim

Yes. We're not sure yet Kevin because we just started that but we will give more guidance later this year.

Kevin DeGeeter

Okay.

Jonathan Lim

It should be a fairly quick study though.

Kevin DeGeeter

Likely in the third quarter in terms of when we might see that data in some context?

Jonathan Lim

It could be, still it is a little early for us to know precisely when but, yes, Q3 or Q4 would be reasonable.

Kevin DeGeeter

Okay, and maybe here just one or two quick timing questions for David here. Help me just – I guess make sure I'm thinking about the cash payments here from Roche in the right manner here. The $10.25 million you received in December that was all received in the fourth quarter, correct?

David Ramsay

No, it wasn't, Kevin. Actually the majority of that was received on January 2nd.

Kevin DeGeeter

Okay and that's the $6 million?

David Ramsay

Yes, correct.

Kevin DeGeeter

So where is the other $4.25 million? Was that in December or is that still –

David Ramsay

That was received in December and booked to deferred revenue.

Kevin DeGeeter

Okay. And the $6 million will be booked to deferred revenue as well?

David Ramsay

Most of it not all of it, but a good chunk of it.

Kevin DeGeeter

Okay, and amortized over what period or reversed under what circumstance?

David Ramsay

Amortized until 2024.

Kevin DeGeeter

Okay, perfect and just help me I guess and understand I don't want to dwell on it, but understand why you received the $4.25 million than the $6 million. I am assuming that pertains to different elements of –

Jonathan Lim

It does, Kevin. The $4.25 million is maintenance payment that had a slightly different payment schedule, and so we received that prior to year-end. So that's something that we'll receive on any annual basis provided Roche keeps their remaining targets, option period open.

Kevin DeGeeter

Okay, and maybe one more from me then I will get back in queue. With regard to exploring strategic alternatives for Chemophase, are you going to wait until later this year and you have a full data package to go out with perspective partners. I'm assuming that's how we should read that announcement or is that something you hope to move aggressively with the data you have in hand.

David Ramsay

Yes, Kevin we're going to be packaging Chemophase with studies that we have and complete those and then put those as part of the package for potential discussions.

Kevin DeGeeter

Okay, so we should think of that as more of a longer-term process at this point?

David Ramsay

That's right.

Kevin DeGeeter

Okay, thanks so much.

Operator

The next question is from Eun Yang.

Eun Yang

Thanks very much. A quick question to David, in terms of the R&D spending, you know, you mentioned that in the fourth quarter there are increased expenses associated with manufacturing ramp up. Could you actually give us some guidance on what the quarterly run rate would be in 2009?

David Ramsay

Sure, Eun. I think, as I mentioned if you take a look at how 2 million of that number was shifted from Q1 ‘09 to Q4. If you just sort of back that out from Q4 that should give you a pretty good sort of estimate of the subsequent quarterly run rate in total.

Eun Yang

Okay, and then your cash guidance – cash usage guidance of $30 million to $35 million based on the increased R&D expense, anticipated R&D expense in ’09. What's the kind of revenue assumptions that you have there.

David Ramsay

Sure. So, as you can see as we incurred in even Q4, we had significant expense but offset by a fair amount of milestones coming in. So a lot of the ‘09 incoming cash, for example, we anticipate from continued receipts of cash from Baxter and Roche. For example, we mentioned that in January we received $5.5 million from Baxter and $6 million from Roche. So that all is offsetting the burn to get you to that $30 million to $35 million number. So we anticipate that continuing as we move our programs forward into the clinic resulting in a net burn of $30 million to $35 million.

Eun Yang

Okay.

David Ramsay

Some of the subtleties in that are, you know, a lot of the cash we get we booked to deferred revenues. So it's not revenue per se.

Eun Yang

Okay, thanks. And then, I'll ask a question to Jonathan. In the new administration’s proposed budget, there is some element there where they are actually kind of proposing to prohibit brand biology manufacturers from reformulating existing product into new product until we start the kind of exclusivity process. They call it like evergreening [ph]. So I just want to get your thoughts on how you think PH20 or Enhanze Technology that Halozyme is developing fitting into that newly proposed budget.

Jonathan Lim

Yes, Eun, based on our current partnership activities if it is a new BLA type of filing, then we don't believe that this new legislation would impact that.

Eun Yang

So initially – our understanding is that this enhanced program would be like (inaudible) to pathway.

Jonathan Lim

Not for biologics, Eun, so the option is either a supplemental BLA or a new BLA, but that's not to mean that there is any significant clinical pathway. So it's not a full-blown clinical development pathway for the enhanced technology type of program. It's really just a matter of whether you file a new BLA for regulatory purposes versus file a supplement to an existing BLA.

Eun Yang

So – this is to make sure I understand. So enhanced products that Roche is developing, you do not think that's kind of a reformulation of existing products. Is that correct?

Jonathan Lim

Correct, absolutely correct. Yes, so that the timing is unchanged.

Eun Yang

Okay, thank you.

Jonathan Lim

Sure.

Operator

The next question is from Chris Geston.

Chris Geston

Good morning.

Jonathan Lim

Good morning, Chris.

Chris Geston

Could you speak to the number of folks that are working directly on additional, let’s call them partnership opportunities and is that different, has it increased over the last 6 to 12 months, and maybe it would be helpful to have the same kind of number of professionals working directly on and with Roche?

Jonathan Lim

Yes, Chris, I will just say that you know, in terms of business development it is always a team effort, and so we have enough then with working on the various options that we are pursuing in parallel. So I will say that the amount of focus and attention on that pathway is significant. And then in terms of the Roche Alliance management, we have also a dedicated team of people working on the support activities and we also pull various degrees of bandwidth and support from existing departments, for instance, product development, manufacturing, R&D, and other areas as needed.

Chris Geston

Terrific. Just going back to the first one, there was a conference call and I don't remember the exact time in which, I think there was some disappointment over the number of team people that were working directly on additional partnership opportunities. My understanding or guess would be that that has been enhanced. Is there any way you could give us a general number or an increase percentage wise.

Jonathan Lim

Yes, I wouldn't focus too much on the number of people within business development, it is more. Are we fully and adequately supporting the outreach efforts that are needed and the question is, or the answer is a definitive, yes.

Chris Geston

Perfect, thanks very much.

Jonathan Lim

You're welcome.

Operator

Your next question comes from Matt Osborne.

Matt Osborne

Hi and thanks for taking the question. Just you can clarify the manufacturing with Cook now, where it stands and is Roche now treating patients with supply from that facility, and what the capacity is there for that in terms of leaders of manufacturing, and does it need to go to another round of increased capacity before Roche move into Phase 2. Thank you.

Jonathan Lim

Yes, so the capacity is 2500 liters, and we will be using material both from Abbott as well as Cook at various stages of development of the Roche products.

Matt Osborne

And is any further progress from Roche dependent upon additional scale that is required or is there sufficient scale now for them to move forward into Phase 2 or Phase 3.

Jonathan Lim

Yes, manufacturing will not be rate limiting in Roche’s development.

Matt Osborne

Okay, great. Thank you.

Jonathan Lim

You're welcome.

Operator

Your next question comes from Andrew Vaino.

Andrew Vaino

Hi, thanks for taking my call and kudos to you guys for having your earnings call on Friday the 13th, that's just fantastic. I was wondering if you could comment, you mentioned that your R&D headcount increased. Can you comment by how much?

Jonathan Lim

Yes, you know, we ended the year Andrew with about 130 employees and about 100 or 97 of those are involved in R&D and that's a significant increase, for example, from year-end 2007 when I believe we ended the year with about 87 employees and about 60 or so were R&D. So, it's probably year-over-year, probably about 50% or almost 50% increase in R&D headcount. And that really is divided or allocated throughout the whole R&D chain.

So, for example, we hired people in research from oncology preclinical, regulatory clinical, just the whole gamut there and particularly now as we have scaled up our clinical program, for example, having three insulin trials running simultaneously right now. You know, extra headcount there was required to move those programs along expeditiously. So just kind of gives you a sense. Most of the increase was in the R&D side, and we don't expect to see that kind of increase in ’09. You know, the increase in ‘09 will be much more modest in terms of headcount, anywhere between 10 to 12 people or so. You know, the bulk of the infrastructure we've needed to build out now, we've done and is able to handle all of our proprietary as well as partnered programs.

Andrew Vaino

Okay, that's great. You mentioned that you had had paper accepted in a peer-review Journal. Is it possible to know which one?

Jonathan Lim

We'll comment on that in the future.

Andrew Vaino

Okay, and secondly, I am just trying to challenge in evaluating your company. Do you guys have any idea of what you expect in terms of revenue for say you know, 2011-2012, or it is still very much premature?

Jonathan Lim

We do Andrew, but we don't disclose it. A lot of that revenue comes from milestones and such from partners and so, you know, they've asked us and particularly Roche has asked us not to give guidance as to those milestones, but we have a very detailed forecast and as you can imagine, do scenario planning and have all sorts of scenarios built into that forecast, and that's – it is that type of planning that gives us the granularity to be able to say that we anticipate ‘09 cash burn to be about $30 million or $35 million.

Andrew Vaino

Excellent, thank you very much.

Jonathan Lim

Okay, thanks, Andrew.

Operator

(Operator instructions) And the next question is from Stephen Harris.

Stephen Harris

Good morning, gentlemen. A very basic question about Roche and Genentech. Do you have a team internally that is going through some of the Genentech products to see if your relationship with Roche can get any deeper after this acquisition?

Jonathan Lim

Yes, what I can say about the Roche and Genentech acquisition is that two targets covered in our partnership with Roche are in Phase I clinical trials, and both of these began during the midst of the Genentech bidding process. So we don't believe that the acquisition process affected the progress of our partnership. The gating factors are all of the usual things you would expect in drug development such as formulation talks, discussions with regulators, etc. So that's a comment on that and then in terms of the possibility of adding other targets to the mix based on the acquisition, well that's always a possibility.

Operator

And then, no further questions at this time.

Jonathan Lim

Okay. Well Halozyme’s unique and exciting business model strikes a balance between proprietary product development programs and partnerships with other companies that aim to leverage our core technology and knowledge base. We are applying our core technology and expertise across several therapeutic categories that represent large established markets and substantial multi-billion dollar commercial opportunities.

Despite the breadth of our programs and the depth of our activities, we continue to operate in a capital efficient manner as demonstrated by our use of $34 million of net cash during the full-year 2008. We believe this strategy will provide multiple opportunities for success that can drive significant value for our shareholders.

We look forward to updating you again soon on our progress and will be presenting at the Cowen Health Care Conference next week on Wednesday, March 18th. We'll also be presenting three abstracts on preclinical results for PEG PH20 at the AACR meeting in Denver on April 19th. Again, thank you for your support and for your interest in Halozyme, and for your participation in today's call. Take care everyone.

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