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Halozyme Therapeutics (NASDAQ:HALO)

Q2 2014 Earnings Call

August 11, 2014 4:30 pm ET

Executives

Schond Greenway -

Helen I. Torley - Chief Executive Officer, President and Director

David A. Ramsay - Chief Financial Officer, Principal Accounting Officer and Vice President

Analysts

Brittany R. Terner - JP Morgan Chase & Co, Research Division

Andrew R. Peters - UBS Investment Bank, Research Division

Charles C. Duncan - Piper Jaffray Companies, Research Division

Joel Beatty

Jason N. Butler - JMP Securities LLC, Research Division

Jason Zhang - Edison Investment Research Limited

John Ryan - Jefferies LLC, Research Division

Operator

Good afternoon, and welcome to the Halozyme Therapeutics Second Quarter 2014 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded. It is now my pleasure to introduce your host, Schond Greenway, Executive Director, Strategy and Investor Relations at Halozyme Therapeutics. Thank you. Mr. Greenway, you may begin your conference.

Schond Greenway

Thank you, operator. Good afternoon, everyone, and welcome to Halozyme's Second Quarter 2014 Financial Results Conference Call. Leading our call today is Halozyme's President and Chief Executive Officer, Dr. Helen Torley. Helen will provide an overview and update on our business. Next, David Ramsay, our Chief Financial Officer, will review our financial results followed by closing remarks from Helen. Afterwards, we will then open the call to your questions.

Before we begin, let me remind you that during this conference call, we will be making forward-looking statements. All statements made during this conference call that are not statements of historical fact constitute forward-looking statements. The company's actual results may differ materially from those expressed in or indicated by such forward-looking statements. For a description of the risks that may affect the outcome, please refer to the quarterly and annual filings with the Securities and Exchange Commission.

I will now turn the call over to Helen.

Helen I. Torley

Thank you, Schond. Good afternoon, everyone, and thank you for joining us today. Since our last call, Halozyme has made tremendous progress across our key product development and partner programs. I'm particularly excited with our progress on our PEGPH20 program and by the recent positive Blood Products Advisory Committee review of Baxter's HyQvia, which is a combination of immunoglobulin 10% and Halozyme's rHuPH20.

Let me begin by providing an update on PEGPH20. Our Phase II trial, Study 202, evaluating PEGPH20 in patients with pancreatic cancer, resumed patient enrollment and dosing in July. As you may recall, in April, we temporarily halted patient enrollment and dosing of PEGPH20 following the Data Monitoring Committee observation of a possible difference in thromboembolic event rate in patients treated with PEGPH20, Abraxane and gemcitabine compared to the group receiving Abraxane and gemcitabine alone. Following data assessment and development of protocol amendment in May, the Data Monitoring Committee indicated their support of a resumption of PEGPH20 dosing. And in June, the FDA agreed to remove the clinical hold.

We immediately initiated the process of gaining independent review board approvals for the protocol amendment, and I'm pleased to report that approximately 75% of the anticipated clinical sites have already received IRB approval with additional approvals expected in the coming weeks. Patient enrollment and dosing resumed in the first sites a few weeks ago and we expect more clinical sites to begin enrolling additional patients in the near term.

The goal of Study 202 protocol amendment is to exclude patients who may be at higher risk for thromboembolic events and to seek to reduce the risk of events through the addition of treatment with low-molecular-weight heparin. A second primary endpoint had been added to assess the thromboembolic event rate in the PEGPH20 treatment arm following the amendment compared to the event rate prior to the protocol amendment. We plan to enroll approximately 100 more patients, adding to the over 100 patients already enrolled. These new patients will be randomized at a ratio of 2:1 to PEGPH20, Abraxane, gemcitabine versus Abraxane and gemcitabine alone. And this approach to randomization is to assure we'll a similar number of patients with no treatment interruption in each of the treatment arms who will then be eligible for the efficacy analysis.

Resumption of patient enrollment has been accomplished in a short period of time and I'd like to thank and congratulate the team here at Halozyme and also the investigators and study coordinators who've worked so diligently to achieve this important outcome.

The second PEGPH20 trial in pancreatic cancer, which is being conducted by SWOG, under an investigator IND, was also halted as a result of the observed thromboembolic events in Study 202. We understand that a proposed protocol amendment is currently under review by the FDA and we look forward to reinitiation of this trial also.

Halozyme remains strongly committed to the full development of PEGPH20, our lead oncology product. Our nonclinical data support that PEGPH20 has potential for development in additional solid tumors that have high hyaluronan content. In selecting the next tumor for clinical testing, we evaluated a number of factors, including expected tumor rate take [ph] content, evolution of the future standard of care and commercial potential. Informed by encouraging nonclinical data, planning is now underway to initiate a trial evaluating PEGPH20 in non-small cell lung cancer patients and we expect this trial to initiate by the end of 2014. Details of the protocol are still being finalized and I look forward to sharing more information with you on this trial at a later date.

Turning now to HyQvia. HyQvia is a combination of immunoglobulin 10% and Halozyme's rHuPH20 that facilitates the absorption and dispersion of the immunoglobulin subcutaneously. HyQvia was approved by EMA in May of 2013 and was launched in the first European market in July of 2013. According to statements by Baxter, HyQvia has now been launched in 7 European countries.

In the United States, on July 31, the Blood Products Advisory Committee of the U.S. Food and Drug Administration convened to review the biologic license application for HyQvia for the treatment of patients with primary immune deficiency disorders. Data presented at the Advisory Committee included a review of the preclinical and clinical data supporting the HyQvia application, specifically addressing the benefit-risk profile as it relates to subcutaneous delivery of immunoglobulin and the development of rHuPH20 antibodies in patients receiving HyQvia.

We are pleased that the Advisory Committee voted 15 to 1 that HyQvia has a favorable risk-benefit profile. The PDUFA date for the amended BLA is in the late third quarter of this year and we look forward to the FDA's response.

Although the FDA is not required to follow the recommendations of its Advisory Committees, if approved, HyQvia may offer patients with primary immunodeficiencies the ability to administer their treatment in a single subcutaneous site every 3 or 4 weeks.

Let me now discuss Hylenex. Our goal is to seek a label expansion for Hylenex, which is currently approved for the increased dispersion and absorption of other injected drugs. We have identified Hylenex pretreatment in patients with type 1 diabetes using insulin pumps as an area where we may create and capture additional value. It's recognized that these patients can face challenges maintaining good glycemic control as a result of the timing of onset and the duration of action of their insulin.

In June, we presented data at the 74th Annual Scientific Sessions of the American Diabetes Association meeting from our CONSISTENT 1 clinical trial. The trial is evaluating Hylenex recombinant and a new formation of Hylenex that is currently under FDA review when these are used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to patients receiving no pretreatment. The total duration of this trial is 24 months and 455 patients have been enrolled. Data reported on the late breaker poster session showed that the study's primary endpoint of noninferiority of A1C at 6 months between the use of Hylenex and the new formulation of Hylenex in comparison to no pretreatment was achieved. The poster also highlighted data indicating that there was a potential reduction in the rate of hypoglycemic events associated with the use of the Hylenex formulation in comparison to no pretreatment. Glycemic excursions after meals and glucose variability were not different between the treatment groups versus the control group. The most commonly occurring treatment-related adverse event in the Hylenex groups was mild infusion site discomfort, and with this exception, adverse events were similar across the treatment and the control groups.

Our dialogue with the FDA regarding a label update for Hylenex, which we initiated earlier this year is ongoing. We do not yet have a clear path for achieving this goal. While our dialogue with the agency continues, we are evaluating the commercial profile of Hylenex for use in type 1 diabetes patients using pumps based on the emerging clinical profile, including the recent results from CONSISTENT 1.

And moving now to our product development programs with Roche. Roche's MabThera SC received European approval during the first quarter of 2014 for the treatment of common forms of non-Hodgkin's lymphoma, which includes follicular lymphoma and for diffuse large B-cell lymphoma. During the second quarter, Roche introduced the product in its first country market in the EU, which triggered a $5 million milestone payment to Halozyme. Following Herceptin SC, this is the second European launch for a novel subcutaneous formulation of one of Roche's oncology products that uses Halozyme's patented recombinant human hyaluronidase technology. With an administration time of approximately 5 minutes compared to the approximately 2.5-hour infusion time for intravenous MabThera, this innovative subcutaneous formulation offers another treatment option that could potentially save time for patients, physicians and other health care providers in Europe. We're pleased with the initial launch with Roche and recent comments highlighting that they are seeing encouraging uptake in some of the early launched European countries.

Turning to Herceptin SC. We continue to be pleased with the uptake of this product. Recent comments from Roche confirmed that Herceptin SC has already achieved 40% to 50% share in a number of key markets in Europe and Latin America. Roche has additionally indicated that, in some markets, they have observed entire systems or hospitals switching their Herceptin use to SC. This speaks volumes to the perceived benefit for patients, hospitals and health care systems in the countries where these products are being commercialized. Based on the recent comments from Roche, we expect continued growth in SC market share versus the IV products through 2014 driven by the recent-launch countries.

Now with that overview, I'll turn the call over to David Ramsay who will discuss our financial results. David?

David A. Ramsay

Thanks, Helen, and welcome to the call, everyone. Earlier today, we announced our financial results for the second quarter of 2014. Revenues for the second quarter of 2014 were $18.4 million compared to $14.5 million for the second quarter of 2013. Revenues in the second quarter of 2014 included $6 million in product sales of bulk rHuPH20 for use and manufacturing products under the Roche collaboration; $7.2 million dollars in collaboration revenues; $3 million in Hylenex product sales; and $1.7 million in royalties, up from $0.8 million in the first quarter. The key driver of this increase in royalties has been increasing sales of Herceptin SC in the early launch markets.

Collaboration revenues benefited from the recognition of $5 million in deferred revenue related to Roche manufacturing scale-up activities.

Our Q2 2014 revenues included royalties from Roche and Baxter of $1.7 million, reflecting Q1 sales as a result of the 1-quarter lag in royalty reports. Roche represented the majority of these royalties.

As we continue to see new countries launching, we expect over the next several quarters to gain a fuller picture of the EU uptake and sales trajectory of these partnered products.

Research and development expenses for the second quarter of 2014 were $18.6 million compared with $28 million for the second quarter of 2013. The decrease was largely driven by the shift in manufacturing costs into cost of goods sold. As you may recall, prior to Herceptin SC approval, manufacturing costs associated with bulk rHuPH20 supplied to Roche was included in research and development expense. Subsequent to Herceptin SC approval, these costs are now included in cost of goods sold. The timing of various manufacturing scale-up activities also contributed to the reduction in research and development expenses.

Selling, general and administrative expenses for the second quarter of 2014 were $8.8 million compared to a $7.3 million for the second quarter of 2013. The increase was primarily due to an increase in compensation costs and patent expenses.

The net loss for the second quarter of 2014 was $16.3 million or $0.13 per share compared with a net loss for the second quarter of 2013 of $22.9 million or $0.20 per share.

Cash, cash equivalents and marketable securities were $147.6 million at June 30, 2014, compared with $164.5 million at March 31, 2014.

Finally, I want to mention that a couple of our directors are approaching the 10-year expiration date of some stock options in the next 2 months. Thus, we expect there will transactions that will be reported in connection with these exercises, such as sales to cover the exercise prices and taxes. You will be seeing Form 4s related to these exercises.

I will now turn the call back to Helen who will provide some closing comments.

Helen I. Torley

Thank you, David. As you've heard, this has really been an important and a strong quarter for Halozyme with key highlights, including the restart of Study 202; significant progress in our planning for the end of-year initiation of our next PEGPH20 trial, which will be in non-small cell lung cancer; the launch of MabThera SC in Europe; and the acceleration of royalties driven by the strong performance of Herceptin SC.

We're now ready to take your calls. Operator, would you please open up the call for questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Cory Kasimov with JPMorgan.

Brittany R. Terner - JP Morgan Chase & Co, Research Division

This is Brittany on for Cory. Can you comment on your commercial strategy for Hylenex for insulin pump users and how do you plan to position this product? And then secondly, what's the approximate percentage of pancreatic cancer patients that are at higher risk of thromboembolic events?

Helen I. Torley

Thanks, Brittany. So with our Hylenex in pump, I think you've heard that, at this point in time, we're engaged in an active dialogue with the FDA to understand what the path is going to be for approval of that product. Our focus will be on type 1 patients and particularly those patients who are wanting to get that tighter glycemic control. And so our strategy is really going to be getting to agreement with the FDA of what it's going to take to give us a label update. We're in process, as I mentioned, of assessing our commercial profile, in market research with physicians, payors and with patients and now we're going to be continuing to review that data and decide on our final commercial strategy at that point in time. Just turning now to your PEGPH20 question, the literature is very wide as to what the background rate of thromboembolic event rate is on pancreatic cancer patients. If you look at the literature, it goes anything from the teens up to 60%. But there's probably an emphasis of data that is in the 20% to 30% range, I would say, in terms of the background rate of all thromboembolic events. But there is a wide range.

Operator

Our next question comes from Andrew Peters with UBS.

Andrew R. Peters - UBS Investment Bank, Research Division

I was wondering if you could get into some of the rationale from a kind of mechanism perspective for why you chose non-small cell lung cancer as kind of the next solid tumor indication. And then you mentioned kind of looking at the treatment landscape going forward in lung cancer. If you could also get into any data, if you have it, or potential combinations with some of the newer types of agents, including the immuno-oncology PD-1 type drugs?

Helen I. Torley

Thanks, Andrew. As we were deciding what our next tumor will be, certainly the percentage of patients we estimate will have high HA expression was an important part of that. If we look at non-small cell lung cancer, probably about 40% of those patients will have high HA. If we look at squamous patients within that, there's probably an even higher percentage of patients, about 50%. That was one of the factors that was very important for us in considering where we'd study. A second factor is looking at our preclinical data. We have done experiments looking in models of non-small cell lung cancer and being able to demonstrate that the addition of PEGPH20 on different therapy had an impact of doubling overall survival in that particular animal model. So those were important factors for us in determining would we study it. Now we are in process. We've done some work in our animal experiments with the immune therapies, in particular. That is a program that we're very focused on and we're planning to expand in our preclinical models. And so I can say, at this point in time, we don't have any clinical data with immune therapies or any animal model in immune therapies in lung cancer, specifically, but that is an area of focus moving forward.

Andrew R. Peters - UBS Investment Bank, Research Division

Great. And then just a quick follow-up for David. The $5 million related to the MabThera, is that going to show up in 3Q?

David A. Ramsay

Yes, it will, Andrew. Absolutely.

Operator

Our next question comes from Charles Duncan with Piper Jaffray.

Charles C. Duncan - Piper Jaffray Companies, Research Division

My question was related to PEGPH20 enrollment. On ClinicalTrials.gov, it looks like there were -- I'm not sure of this data, I didn't generate it, it actually came from my associate. 237-or-so patients enrolled and we estimate 132 before the hold. Is that approximately correct? Or is that data that is -- needs to be updated?

Helen I. Torley

So our target for enrollment will be 237 patients, Charles. That number is correct. What we've said is that we exceeded 100 patients before we went on temporary hold with the trial. So the 132 number is directionally correct.

Charles C. Duncan - Piper Jaffray Companies, Research Division

Okay, that's helpful. And I think you mentioned approximately 75% of sites had received IRB approvals. Does that imply they've actually enrolled patients? Or is that jumping the gun a little bit?

Helen I. Torley

That's jumping the gun a little bit. A number of centers have started enrolling. A number of centers -- I would say every week we have additional centers who have been trained and are ready to start enrolling. So we're going to see these centers ready to start screening and enrolling their patients, just coming on everyday and every week moving forward. But a handful at the moment are actively enrolling.

Charles C. Duncan - Piper Jaffray Companies, Research Division

Okay. And I can -- I guess, I can assume -- we've talked about this before, but is it still the case that those patients who were prior to the re-enrollment maybe going to be exposed to or there's going to be some kind of subgroup analysis to break them out and you'll be looking at different populations in the analysis of their response from the study?

Helen I. Torley

Yes, the primary analysis will be based on patients who have had no treatment interruptions. So the patients who had their events before the temporary hold and the patients who were enrolled after the amendment had gone into place. But as you mentioned, there'll be a cohort of patients who had a treatment interruption. We still think there will be things to learn from those patients. So they're part of a secondary efficacy analysis, but the primary efficacy analysis will be based on patients who have not had any treatment interruption.

Charles C. Duncan - Piper Jaffray Companies, Research Division

Okay. And then, Helen, last question, if we could go back to the questions on Hylenex. The previous person was asking regarding your commercial strategy and maybe regulatory strategy. Do you have a goal in mind as to when you may be ready to update that plan?

Helen I. Torley

Well, Charles, we continue in an active dialogue with the FDA. And I think just to bring a little color as to why it's not as straightforward as we might or you might be hoping for, really when you think about Hylenex, it is a pretreatment of patients who are receiving insulin. The metabolism division has got guidances for insulin, mixes of insulin, oral hypoglycemic agents. We're a little bit different and unique. There's not been anything quite like this. And so that's why we're having such an active and productive dialogue with the FDA, it's just what are the expectations for this type of approval. So just given that there is no clear precedent for it, it's hard to pin down an exact time wall [ph] of clarity. But what I can say is we're working very hard and are actively engaged with the FDA to get that clarity just as soon as possible.

Operator

Our next question comes from Joel Beatty with Citigroup.

Joel Beatty

This is Joel Beatty on for Jon Eckard. The first question is would it be reasonable to expect the launch of MabThera subcu and to progress similarly to the Herceptin subcu launch? Or are there differences between those 2 products to keep in mind? And then I have a follow-up.

Helen I. Torley

I think in their prepared remarks, Roche hasn't shared any reasons for any differences nor have they exactly said they expect it to be the same as Herceptin. So I really -- I don't think I can comment with knowledge on that. I can say that, Roche, in a similar way for Herceptin, generated data that showed strong patient preference for MabThera SC, as well as similar time and motion studies that showed cost savings for the health care system and time savings for patients. So a lot of the aspects of the Herceptin SC update, which are the savings for the health care system are also going to be present for MabThera. Additionally, Roche similarly priced it at parity. So I can observe that Roche is taking a very similar strategy. They just haven't commented on their expectations for uptake.

Joel Beatty

That's helpful. And then as a last question, just with the collaboration with Roche appearing to go well, could we expect to see more of subcu drugs from them such as a subcu version of Gazyva?

Helen I. Torley

Roche -- the contract we have with Roche is for 8 products. Roche is really in the lead with when they make it public. Are they working on a program or are they advancing a program, I'm not really in a position to say anything at this time.

Operator

Our next question comes from Jason Butler with JMP Securities.

Jason N. Butler - JMP Securities LLC, Research Division

Just another follow-up on the Hylenex diabetes opportunity. Could you maybe give us a little more color on what your target indication would be or what your label claims that you would view as necessary to make this commercial opportunity attractive? And conversely, is there a scenario here where you think that there is not an attractive label opportunity to make you move forward?

Helen I. Torley

So Jason, thanks for that question. And in terms of the indication, we're wanting an indication that says Hylenex can be used in pretreatment of type 1 diabetics using CSII, so it can be used with any of the commonly used prandial insulin. And what we'd really like to get is data into the package insert, the Hylenex package insert, that allows our representative to have a dialogue with the physicians about the efficacy data seen and also the safety data seen because, clearly, it's important we're able to articulate the risk-benefit of our drug to physicians. And it's important that data is in the label to allow that type of dialogue that would need to happen. It's our goal to pursue the dialogue with the FDA to understand what is going to take to get the indication we want and that data in the label. And at this point in time, we're continuing in a productive dialogue. So that really is where we're focused at this time.

Jason N. Butler - JMP Securities LLC, Research Division

Okay, great. Just to follow up on that. When you talk about the efficacy data, is that in your mind relative to standard of care? Or is that a placebo comparator?

Helen I. Torley

So the clinical study, the one clinical study we've done, CONSISTENT 1, which is in a 455 patients, we compared Hylenex on top of continuous infusion versus continuous infusion alone. So the data would be relative to no treatment. So just the standard of care, I guess, to answer your question.

Operator

Our next question comes from Jason Zhang with Edison Investment Research.

Jason Zhang - Edison Investment Research Limited

Helen, this is Jason. Now that dosing has resumed, when do you think you will be ready to give us an update about when the enrollment will be complete for the PH20 program?

Helen I. Torley

Thanks, Jason. Enrollment has just started and what we are wanting to do is obviously see, with the restart of the study, what the new rate of enrollment is going to be. We obviously had strong enrollment before we had the clinical hold. I'm pleased to report investigator enthusiasm for the trial remains high, but I want to see some data points in terms of what the new enrollment rate is before we project out when we think enrollment will be complete. As I'm sure you understand, there's been some changes to the enrollment criteria. So let's just wait for some data before we forecast that one out for you.

Jason Zhang - Edison Investment Research Limited

Okay. And then are you still on track to initiate a clinical trial for the second indication of PH20?

Helen I. Torley

Yes, our goal is working hard to initiate a study in non-small cell lung cancer by the end of this year. We haven't provided any more details as we're still finalizing the protocol on the line of therapy or the combination we'll be studying. But as we finalize that at the appropriate time, we will obviously make that public to you.

Operator

Our next question comes from Eun Yang with Jefferies.

John Ryan - Jefferies LLC, Research Division

This is John in for Eun. So assuming you guys get the label update that you want for Hylenex in an [ph] insulin pump, how should we think about the number of reps needed for commercial launch? And then i have a quick follow-up.

Helen I. Torley

John, the part of the work we're doing at the moment is really seeking to understand the patient segment, who we will be going after with the clinical profile that we have and identify how many endocrinologists are going to be looking after this type of patient. As you realize, not every endocrinologist is looking after pump patients. We do think this is a small segment of endocrinologists, but that's work that we're still doing to refine that information, so it would be premature to comment. But I think in terms of rep field force size, it'll be a relatively modest one because it's a small specialist group of endocrinologists who would be looking after this indication.

John Ryan - Jefferies LLC, Research Division

Okay. And then if you could provide any color on the in HTI-501 program and Intrexon's A1AT in preclinic, that would be great.

Helen I. Torley

Okay. So with regard to HTI-501, we reported at the end of March our positive proof of concept data that showed in a clinical setting we were able to improve the appearance of cellulite by a number of measures. As we took a step back and looked at that program, we recognize that within Halozyme, we don't have expertise in the development of aesthetic products. And we initiated a process to identify a strategic partner with whom we could advance the program. That assessment and dialogue is still ongoing and I've nothing I can update you on that at this point in time. With regard to the Intrexon program, Intrexon determined for business reasons to not proceed with that and actually terminated their agreement with Halozyme. I think that was reported last quarter and so we don't have any ongoing activities with Intrexon at this time.

Operator

[Operator Instructions] There are no further questions at this time.

Helen I. Torley

All right. Thank you, everyone for joining us today. Obviously, strong progress, and we look forward to speaking with you on our next call. Have a good evening.

Operator

Thank you, ladies and gentlemen, this concludes today's conference. You may now disconnect.

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