Earnings Labs

Halozyme Therapeutics, Inc. (HALO)

Q3 2009 Earnings Call· Fri, Nov 6, 2009

$63.26

-0.94%

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Transcript

Operator

Operator

Welcome to the Halozyme 2009 third quarter 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, November 6, 2009. I would now like to turn the call over to Robert Uhl. Please go ahead.

Robert Uhl

Management

Thank you, Adrian, and thanks also to everyone for participating in today’s call. I’m 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 Kurt Gustafson, 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 2009 third 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 [ph] at 858-704-8288. This call is also being webcast 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 to 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 Jonathan Lim, President and CEO.

Jonathan Lim

President and CEO

Thanks Robert. Good morning everyone and thank you for joining us on the call. Halozyme continues to make exceptional progress in 2009. Today, I will review our recent accomplishments and update the status of our key proprietary product development programs and our three 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 most recently completed quarter and for the nine months. We had an opportunity to see many of you at our recent Analyst Day meeting in New York on October 15th, where we provided an extensive discussion of our technology and our scientific understanding of the extracellular matrix. We also provided an update on our key programs and revealed some of the earlier stage preclinical activities at Halozyme including enzymes that degrade collagen within certain temperature and PH ranges. A replay of the Analyst Day presentation can be found on Halozyme’s website at www.halozyme.com. Since our Analyst Day, we were able to make a very exciting disclosure with the announcement of patient dosing in a Phase III trial of subcutaneous Herceptin with our PH20 enzyme. What makes Halozyme an incredibly unique and attractive investment opportunity is the fact that our core technology is being applied to existing blockbuster products such as Herceptin, a product with almost $5 billion in worldwide sales in oncology, mealtime insulin which is in a rapidly growing $3 billion market in endocrinology, and GAMMAGARD a product with approximately $1 billion in worldwide sales. We continued to pursue large multi-billion dollar franchise opportunities in the areas of endocrinology, oncology, dermatology and drug delivery. And we have a robust pipeline of therapeutic candidates within these therapeutic areas. Within these categories, we have proprietary product development programs where our goal is to…

Kurt Gustafson

CFO

Thank you, Jonathan, and good morning, everyone. The net loss for the third quarter of 2009 was $13.9 million, or $0.16 per share, compared with a net loss for the third quarter of 2008 of $10.9 million, or $0.14 per share. For the nine months ended September 30th, the net loss was $45.7 million, or $0.54 per share, compared with a net loss of $31.8 million, or $0.40 per share for the comparable period last year. Revenue for the third quarter of 2009 was $3 million, compared to $2.5 million for the third quarter of 2008. Revenues under collaborative agreements for the third quarter of 2009 were $2.6 million, compared to $2.2 million for the third quarter last year. Revenues under collaborative agreements for the third quarter of 2009 consisted of the amortization of license fees and a milestone payment received from Baxter and Roche as well as the reimbursement of research and development work for our partners. Research and development expenses for the third quarter of 2009 were $13.2 million that compares to $10.1 million for the third quarter in 2008. This is primarily due to an increase in the clinical trial expenses as a result of higher spending on the ultrafast insulin program, and an increase in our R&D headcount. SG&A expenses for the third quarter of 2009 were $3.7 million, compared to $3.5 million for the comparable period in 2008. Our financial position remains solid with cash and cash equivalents of $77.6 million as of the end of September 2009. That compares with $63.7 million as of December 31st, 2008. Our net cash burn for the third quarter of 2009 was $11.6 million. Excluding the proceeds of the $40 million from our equity financing in June, we are still comfortable with our net cash burn guidance of between $30 million and $35 million for the year. We are in the midst of our budget planning process right now, and so, we would expect to provide financial guidance for 2010 when we report our results for the fourth quarter of 2009 and should be in the first part of next year. I will now turn the call back to you, Jonathan.

Jonathan Lim

President and CEO

Thanks Kurt. At Halozyme, I believe we are making tremendous progress in advancing both our proprietary programs and our partnerships as rapidly as we can. So with that overview, let’s open it up for questions. Operator?

Operator

Operator

(Operator Instructions). And your first question comes from the line of Eun Yang. Eun Yang – Jefferies & Company: Thanks. Regarding the Baxter collaboration for subcu GAMMAGARD, CSL also has subcutaneous immunoglobulin product that is currently under regulatory review. Could you Jonathan – could you comment on the difference between CSL product versus subcu GAMMAGARD from Baxter?

Jonathan Lim

President and CEO

Yes, so the CSL product which is called Vivaglobin is essentially a product that’s given subcutaneously. The problem with IGG when you take IGG without enzyme and you try and inject it subcutaneously is the fact that it has very low bioavailability or absorption in the bloodstream relative to the IV. So the bioavailability is on the order of roughly 63% or so. And as a result of that, you have to give a super high dose, so you have to give about 135% of what you would normally give. You have to do it through multiple injection sites, often four to six injection sites because you got to fractionate the doses and then you also have to give it weekly instead of monthly. So the benefit of subcutaneous GAMMAGARD with PH20 is the fact that the bioavailability in the Phase I-II study showed that the BA goes up to 93% or 92% and therefore allowing you to give just the usual dose of GAMMAGARD subcu through just one injection site and through once-monthly frequency instead of once weekly. So from a convenience perspective, the value to the patient is significant, because they can continue to get the GAMMAGARD as an outpatient therapy through one injection site on a monthly basis. Eun Yang – Jefferies & Company: Okay. And that’s helpful. And one question around financials, OpEx for third quarter was a little bit down sequentially. Is that the third quarter raised rate that we should assume for the remainder of the year?

Kurt Gustafson

CFO

I think typically our third quarter is a light spending just over the summer time periods. And I think if you take a look at our nine-month results and used that that might be a better trending sort of number. Eun Yang – Jefferies & Company: Okay. Thank you.

Operator

Operator

And your next question comes from the line of Terence Flynn. Terence Flynn – Lazard Capital Markets: Hi, thanks for taking the question. Just I was wondering if you guys can comment on now that Roche has announced the start of the Phase III Herceptin trial which is the first one under that collaboration, if that’s generated any interest among new potential partners and maybe you can provide us some insight into any discussions there. Thanks.

Jonathan Lim

President and CEO

Sure. Yes, any – what I can say Terrence is that any validation that we display with our existing partnerships is good signals to ongoing discussions with prospective partners. So the simple answer is yes. That’s a a major milestone for the collaboration with Roche and it’s beneficial for business development activities which continue to be underway. Terence Flynn – Lazard Capital Markets: Okay. Thanks a lot.

Jonathan Lim

President and CEO

Sure.

Operator

Operator

(Operator Instructions). And your next question comes from the line of Chris Geston. Chris Geston – UBS: Good morning.

Jonathan Lim

President and CEO

Good morning, Chris. Chris Geston – UBS: This may have been answered somewhat, but along the lines of the partnership question, you have given some additional color on all that goes into those discussions, the analysis both from the potential partner and your side. Could you give any more detail as far as what you are the profile of what you all are looking for – how many serious candidates are in that process, given that it can take 12 to 18 months I think that’s what you said, and what the tone those are, and just your idea of probability and optimism?

Jonathan Lim

President and CEO

And Chris is your question with respect to insulin or Enhanze Technology or both? Chris Geston – UBS: Partnership in all phases, all areas.

Jonathan Lim

President and CEO

Okay. Chris Geston – UBS: Partnership discussions.

Jonathan Lim

President and CEO

Well, what I can say is that just laying out the process to answer your process question. Typically, you give a non-confidential presentation to the prospective biopharmaceutical partner. And then if there is further interest, then you both parties sign a CDA or a confidentiality agreement, and then a confidential presentation is given. And then after that, if there is further interest, then it can proceed to an MTA or a material transfer agreement. And from the MTA, that’s a proof-of-concept animal study typically for the partner to run a study or two with the enzyme plus their candidates. And then from there, if there is further interest, it goes to term sheet discussions and then to contract discussions. So that basically is the process. And that process can often times take a while with the prospected partners. And so what we have said is that we continue to move folks along that process and there is multiple parties that are moving along in different phases. Chris Geston – UBS: And includes term sheet base, proof-of-concept base and everything.

Jonathan Lim

President and CEO

Yes, I mean I am going to give you a detailed breakdown, but what I can say is that we are advancing discussions in with every new milestone in validation of existing partnerships, all of that is very helpful. Chris Geston – UBS: Thank you.

Operator

Operator

And your next question comes from the line of Andrew Vaino. Andrew Vaino – Roth Capital Partners: Hi, just a quick question on the pegylated hyaluronidase the Phase I study. In terms of the adverse events, you guys can be looking specifically at effects on joint movement and the like?

Greg Frost

Analyst · Andrew Vaino

Hi Andrew, it’s Greg Frost here. Yes, obviously the program has all of the standard criteria to look for at any AE profile going through in addition to the pharmacokinetics and as well as pharmacodynamic markers if looked at. Obviously as you can imagine from the standpoint patient population is going through, always going to be comorbidities and other elements going through. But the groups that are running this are very experienced as far as teasing through all those sorts of things. Andrew Vaino – Roth Capital Partners: Okay, thanks. And on the program for the dermal scalping, can I assume since you guys are going to start the GMP manufacturing next year that a Phase I clinical or an IND filing won’t be until the last half of next year or first half of 2011?

Greg Frost

Analyst · Andrew Vaino

Yes in essence what we would like to do from the stamp and I think it’s a good ideas to check in mid next year when we go through. From a development standpoint, I think you are aware the sets that go through as far as GMP manufacturing and then IND enabling toxicology. But because in each process there is different gates where there can be elements from timing that we think it’s best to go through and check in mid next year, we can give you probably some more granularity about specific timing at least (inaudible) is going to be what quarter sort of thing you might be looking at.

Jonathan Lim

President and CEO

But it’s an element that’s just better to give more granularity next year. Andrew Vaino – Roth Capital Partners: Great, thanks.

Operator

Operator

And your next question comes from the line of Jonathan Aschoff. Jonathan Aschoff – Brean Murray, Carret & Co.: Hi guys, good morning.

Jonathan Lim

President and CEO

Hi Jonathan.

Greg Frost

Analyst · Jonathan Aschoff

Jonathan. Jonathan Aschoff – Brean Murray, Carret & Co.: I was wondering if you could help me understand the GAMMAGARD population or is there any – are there any sub populations that would be extremely rapid adopters of a subcu version, are there any reason that any population would be particularly slow geographically whatever reason there is? And afterwards if this were to work, is there any reason Baxter or whoever want to continue offering an IV version?

Greg Frost

Analyst · Jonathan Aschoff

Yes I can go through and speak a little bit to the prevalent element going through. There are certain indications – so if you look today, for example, about 40% of all IGIV is administered from home infusion services going through, so those are obviously the first key targets we think that make sense. As far as sub populations, there are things for example Kawasaki’s disease which are rare indications for IGIV products. But these aren’t given in either acute settings or other areas where they are predominantly administer in a hospital setting while they comprise a very small part of the overall market. Those would be specific areas where we wouldn’t see rapid adoption. So obviously you can go through and say that people that are on subcu today, those are going to be your early adopters and then probably the folks that are using the product at home. Jonathan Aschoff – Brean Murray, Carret & Co.: Okay. You were saying 40% at home.

Greg Frost

Analyst · Jonathan Aschoff

If you go back, there is a meter deficiency surveys that goes through an absolute breakdowns of these products, little bated, but still quite relevant. Jonathan Aschoff – Brean Murray, Carret & Co.: Okay thank you very much.

Operator

Operator

And there are no further questions at this time.

Jonathan Lim

President and CEO

All right. Well, thank you everyone for joining us on this call. As I mentioned in our opening remarks, Halozyme has accomplished an impressive list of milestones in 2009. Our ultrafast insulin program has advanced into Phase II and additional studies continue to build value for the program. Roche has started its first Phase III registration trial for a subcutaneous formulation of Herceptin with PH20 resulting in a $5 million milestone payment to Halozyme. Baxter’s Phase III registration study for subcutaneous GAMMAGARD with PH20 is fully enrolled and is expected to be completed by the end of 2010. The launch of Hylenex is underway for pediatric rehydration with the substantial marketing resource commitment by Baxter. In June, Halozyme successfully completed a $40 million equity financing when the window for biotech first opened. We expect the momentum for many of our activities will continue into 2010 when we look forward to updating you on our future progress. Halozyme’s business strategy strikes a balance between proprietary product development programs and partnerships with other companies that aim to leverage a core technology and knowledge base. We continue to operate in a capital efficient manner as demonstrated by our use of $34 million of net cash for the year 2008, followed by our net cash burn of approximately $25 million during the first nine months of 2009, excluding the effect of the June financing. We believe our 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 we will be participating in the Lazard Capital Markets Healthcare Conference in New York on November 18th, and we will also be at the JPMorgan Conference in San Francisco during the second week of January. Again, thank you for your interest in Halozyme and for your participation in today’s call. Take care, everyone.

Operator

Operator

And this concludes today’s conference. You may now disconnect.