Halozyme Therapeutics (NASDAQ:HALO)
Q4 2012 Earnings Call
February 25, 2013 4:30 PM ET
Kurt Gustafson - Vice President and Chief Financial Officer
Gregory Frost - President and Chief Executive Officer
Matthew Harrison - UBS
Ying Huang - Barclays Capital
Nicholas Abbott - BMO Capital Markets
Gregory Wade - Wedbush Securities Inc.
Chris Geston - UBS
Greetings and welcome to the Halozyme Therapeutics Fourth Quarter and Year ended 2012 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, Kurt Gustafson, Chief Financial Officer at Halozyme Therapeutics. Thank you. Sir, you may begin your conference.
Thank you and good afternoon. Welcome to Halozyme’s quarterly update and 2012 year-end conference call. Joining me on the call today is Gregory Frost, President and Chief Executive Officer. This morning Halozyme released fourth quarter and year-end 2012 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 email Temre Johnson at firstname.lastname@example.org. 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 fourteen 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 Gregory Frost, Halozyme’s President and CEO.
Thank you, Kurt and good afternoon to everyone. We appreciate you joining us on Halozyme’s fourth quarter and year-end call for 2012. This afternoon we will be providing further detail on the items in the press release issued earlier today. I will provide an update on the status of some of our key clinical programs, including significant progress made with our wholly-owned programs as well as the clinical programs from our collaborations. Kurt will then provide additional detail on the quarter and underlying financial results and comment on our outlook for 2013.
As we enter 2013, it is important to note that this year will be an important one for us. Halozyme is well positioned with a diverse mix of partnered and proprietary products in registration and later stage trials.
To put this into perspective, we currently have three products under EMA review on the partnered front. On the proprietary front we have two products driving towards clinical milestones and are making steady progress toward commercial readiness of Hylenex for insulin pumps. We will get into more updates on many of these items on the call, but suffice it to say, we are energized at Halozyme about the many near-term catalysts.
Let’s first review the highlights from the fourth quarter of 2012. It was a quarter marked by progress on many fronts, including current collaborations and the addition of a new partnership.
For those of you that have been following us know that we ended the year with the signing of a new multi-target Enhanze Technology collaboration and licensing agreement with Pfizer. This is a very promising collaboration that has helped expand our partnered approach going into 2013.
Under the terms of this agreement, Halozyme has granted to Pfizer a worldwide license to develop and commercialize products combining rHuPH20 with Pfizer proprietary biologics directed to up to six targets. To date, Pfizer has elected three exclusive targets in Primary and Specialty Care. While this represents our newest collaboration, the teams at Pfizer and Halozyme are already working closely together to evaluate these targets, and we look forward to updating and providing more information on this collaboration in the future.
Moving on to the progress with our other partners. In Q4 we saw progress on our ViroPharma collaboration with Cinryze and hit a major milestone with the EMA filing of Roche’s MabThera/Rituximab subcutaneous in non-Hodgkin’s lymphoma.
In December, ViroPharma announced they initiated a Phase 2b study to evaluate the safety and efficacy of subcutaneous administration of Cinryze in adolescents and adults with hereditary angioedema for prevention of HAE attacks. ViroPharma has indicated that they expect this study to be completed this year, and we look forward to seeing the results from this program.
In early December, Roche announced the filing of subcutaneous MabThera for a line-extension marketing application with the EMA. This filing marked the third biologic to be filed in the EMA utilizing our rHuPH20 technology. Clinical data were also presented at The American Society of Hematology meeting from two studies which showed that a fixed dose of MabThera can be administered subcutaneously, with the objective of allowing patients to spend less time in infusion centers while receiving treatment. These studies demonstrated comparability to IV administration, enabling the submission of the line extension application.
Administering MabThera subcutaneously shortens the treatment time significantly for patients, and may enable administration over approximately 5 minutes compared with several hours during IV infusion. The ready-to-use subq formulation may also reduce the impact on pharmacy and hospital resources as medicine preparation and hospital staff time per administration are reduced. MabThera subq may be an important new option for patients with non-Hodgkin’s lymphoma, providing an easier, less invasive and more efficient route of delivery without compromising the established safety and efficacy of the intravenous product.
Given standard EMA reviews, we would expect a decision on MabThera SC within 18 months from the time of the application filing.
Looking forward to 2013, we anticipate an exciting year, with three partnered products under EMA review and two products that will hit key clinical milestones on the proprietary front.
First, for the partnered programs. As many of you are aware, both MabThera SC and Herceptin SC are under EMA review. We already discussed the MabThera progress, so let’s turn to the subq Herceptin program.
Roche announced during their Q4 earnings call that Herceptin SC CHMP opinion will be delayed until Q2 2013. While we would have loved to obtain the opinion in Q1, the timing is still consistent with the European regulatory review process and in line with our previous forecast to see a decision in the first half of 2013.
This subcutaneous formulation of Herceptin could allow for time savings for both patients as well as their healthcare providers. With Herceptin subq, dosing takes approximately 5 minutes, versus anywhere from 30-90 minutes with IV administration.
On the Baxter front, we are also awaiting a decision on HyQ from CHMP, which Baxter anticipates will occur in the first half of 2013. Additionally, Baxter has stated they plan to meet with the FDA in the second quarter to review the path forward for HyQ in the U.S.
Regarding our proprietary programs, we are encouraged with the progress of our PEGPH20 with chemotherapy study in patients with stage IV previously untreated pancreatic cancer. For those of you not familiar with this program, I want to provide a little background. In most patients presenting with metastatic pancreatic adenocarcinoma, survival is still less than one year – and represents significant unmet need. These types of cancers produce a matrix shield which helps protect them from anti-cancer therapies. We believe that depleting a component of this matrix with PEGPH20 disrupts the tumor architecture and makes these tumors more vulnerable to many types of therapies.
Our Phase 2 clinical trial, with a 1b run-in period, for patients with metastatic pancreatic cancer is currently ongoing and the enrollment of the run-in phase is complete. We have confirmed the recommended Phase 2 dose of PEGPH20 in combination with gemcitabine. However, recent results from the IMPACT Phase 3 study demonstrated that ABRAXANE with gemcitabine demonstrated a clinically significant increase in overall survival compared to gemcitabine alone. Therefore, it is anticipated that ABRAXANE plus gemcitabine as a regimen will likely replace gemcitabine alone as the standard of care chemotherapy backbone for patients with metastatic pancreatic cancer. As a result, we have made the strategic decision to initiate the randomized Phase 2 trial to assess the safety, tolerability and efficacy of PEGPH20 in combination with gemcitabine and ABRAXANE as the backbone treatment. The clinical team is driving to initiate this trial in the first half of 2013 and we look forward to presenting the complete single arm stage from approximately 26 patients treated with PEGPH20 with gemcitabine alone this year.
In an effort also to advance our knowledge regarding the most impactful therapeutic approach, we are also working with physicians to support an Investigator Sponsored Trial using PEGPH20 with a folfirinox regimen.
We continue to explore whether subpopulations of patients also with other types of cancers that accumulate this hyaluronan-rich matrix can benefit from PEGPH20. To test this hypothesis, we have been developing companion diagnostic tools that allow us to identify patients with tumors that accumulate hyaluronan. We can therefore explore the development of additional trials with other appropriate tumor types in future.
Regarding the Hylenex product in insulin pump program, there are a number of elements there as well that we are currently putting in place to ensure a successful commercial introduction. These include such activities as ensuring administration solutions being available to patients; scaling-up drug product manufacturing processes to ensure adequate supply to support market demand and completing Phase 4 studies to gather additional data that will enable us to provide healthcare providers with data in the relevant patient population they need in order to prescribe. Our Phase 4 trials will initially focused on patients with Type 1 diabetes.
We are making steady progress on all fronts here and expect that Hylenex as a brand should be significantly contributing to our revenue growth by the end of 2014.
Additionally, we expect to report results from the randomized clinical study the HTI-501 program for aesthetics at a medical conference in the first half of this year.
Now that we’ve discussed major milestones from last year and highlighted some key milestones for 2013, let’s talk about the strategic direction of the Company over the coming year.
We are going to continue to manage this company for long-term growth, which means continuing this model of pursuing our innovative proprietary programs buffered by platform-based partnership revenue. There are four strategic drivers to our business strategy. First, we will continue to secure revenue from existing channels. A regular stream of milestone and royalty payments from our established partnerships, and revenue from our wholly-owned product, Hylenex, will provide a continuous source of cash stream.
Second, we will continue to pursue additional, high-value partnerships by leveraging our validated technology to reach new markets. At the same time, we will advance our proprietary pipeline, investing in and progressing innovative development programs that leverage our expertise in extracellular matrix science and position the Company for organic growth by commercializing assets where we can continue to add value.
Lastly, all of these activities, along with our strong financial discipline, could allow us to drive toward positive cash flow by 2014.
With that, I will turn the call now over to Kurt Gustafson who can provide more detail on our financial results released earlier this morning.
Thanks, Greg. Earlier today, we announced our financial results for the fourth quarter and the year ending December 31, 2012.
The net loss for the fourth quarter of 2012 was $4.4 million, or $0.04 per share, compared with a net loss for the fourth quarter of 2011 of $18.4 million, or $0.18 per share. The net loss for the year ended December 31, 2012 was $53.6 million, or $0.48 per share, compared to a net loss of $19.8 million, or $0.19 per share for the comparable period in 2011.
Revenues for the fourth quarter of 2012 were $21.8 million, compared to $2.4 million for the fourth quarter of 2011. Revenues in the fourth quarter of 2012 included license fee revenue from Pfizer of $9.5 million and a milestone payment from Roche of $4 million.
Research and development expenses for the fourth quarter of 2012 were $18.6 million, compared with $14.9 million for the fourth quarter of 2011. The increase was due primarily to an increase in manufacturing activities to support potential launches from our collaborators.
Selling, general and administrative expenses for the fourth quarter of 2012 were $7 million, compared to $5.9 million for the fourth quarter of 2011.
Cash and cash equivalents were $100 million as of December 31, 2012, which includes net proceeds of $29.7 million from a term loan with Oxford Finance and Silicon Valley Bank. Excluding the proceeds from the term loan, net cash used in the fourth quarter of 2012 was approximately $17.4 million. The loan was funded on December 28 and has an effective interest rate of 10.5%. The loan is secured by substantially all the assets of the company excluding IP and carries a customary set of reps and warranties and covenants.
Financial guidance for 2013 was announced on January 7and remains unchanged, with an expected net cash burn to be between $45 million and $50 million.
I will now turn the call back to Greg who will provide some additional thoughts.
Thanks, Kurt. Before the close of this part of today’s call, I want to take a moment to acknowledge and thank the employees at Halozyme whose hard work and dedication enabled numerous accomplishments in 2012. We delivered on some significant milestones that position us for achievements this year that will help us build long-term shareholder value, and enable us to advance patient care through truly innovative therapies.
I will now ask the operator to open the lines for questions.
Thank you. We will now be conducting the question and answer session. (Operator Instructions). Our first question comes from line of Matthew Harrison with UBS.
Matthew Harrison - UBS
I have 2 for you. So first is, can you give us any more detail on when we should see the HTI-501 data and perhaps when we should be thinking and what kind of data we'll get? And then secondly, I think a lot of investors were perhaps surprised or concerned around the comments Roche made around Herceptin subcu. Maybe if you could provide a little bit more of your thoughts around the potential impact to you guys if that product is maybe -- given that Roche has 2 branded alternatives now and perhaps how subcu Herceptin might not be as big a part of their strategy for Herceptin going forward, obviously, Herceptin will still be used though given that it's dosed in combination with Perjeta and some other agents. So maybe if you'd just give a little more detail around how you think about that as a contributor to your revenue.
Sure, Matt. So first, regarding the HTI-501 program, as we noted, I think with folks will be presenting the data on the first half of the year and there are a few factors that influence the time line on this, but principally, refinement of the dosing algorithm that we brought in and being a bit more selective with enrollment criteria. But that trial has progressed together nicely, and we expect to present the data in the first half of the year. So when we look at what data we'll see, there's really 3 components of this. This is a multi-field injection that's being done. It's placebo-controlled and from a double dummy blinded situation. So effectively, there's an analytical component, which relates to volumetric assessments of lesions and then there's a physician, as well as a patient score that comes into that. So we think that this, while it's not going to obviously from this particular point, the information we'll get from this will help for us to know if the agent is active in a very well-controlled setting in a representative field. There's still obviously development work that needs to be done from manufacturing and other components that would take some time. But we think as far as understanding the clinical pharmacology of the agent that we'll be in a very good position there.
So maybe if we just spend a minute regarding -- with the Herceptin franchise, I think, in general, Roche obviously has reiterated that Herceptin as a brand it's certainly an important product for them. And I think based on the way that they continue to work with us, the outlook for the near-term potential of Herceptin SC really remains unchanged and certainly, in countries such as Europe. But as we've noted previously, about 1/3 of our R&D expenses in 2012 were to prepare launch inventory for partners and this trend's continuing into 2013. And I think if we were to step back and look, Roche has certainly invested, I think, in clinical trials with this program, things such as SafeHer in 2,500 patients in 60 countries to look at the ability of patients to safely administer Herceptin subcu. So while I don't think we have a perspective as far as the long-term horizons on these sorts of things as far as the near term, the position, for us, kind of remains the same.
Our next question comes from the line of Ying Huang with Barclays.
Ying Huang - Barclays Capital
I have a couple. Number 1 is, to the extent you can, Greg, can you comment on exactly what is the nature of the questions from CHMP that, I guess, result in the delay for the subcu Herceptin filing? And then, secondly, I know you want to strategically add Abraxane to the mix for the Phase II trial for PEGPH20 here, but have you done -- guys done any preclinical work to show that when you have put the 3 drugs together, you won't have any funny interactions here?
Sure. Okay, let me cover the first one with regards to questions from CHMP on this. Obviously, given this file's currently under review, we can't speculate about either CHMP feedback or the distinct questions. But with regards to timing, this is certainly within the time frame typical for a review of this nature, and Roche has announced they expect a CHMP opinion in the second quarter of 2013. So I think from that perspective, we support them on the PH20-related questions, but effectively, this is their file and, certainly, appreciate the approach they have and are working with European regulators.
With regards to PEGPH20 on the preclinical side, we've actually presented some of this data, I think, perhaps last year in some of the preclinical models of pancreatic cancer. And essentially, when we looked at nab-paclitaxel with gemcitabine and PEGPH20 in the types of models that we've previously looked at, the doublet as opposed to the triplet, the first is that the activity of the 3 together has certainly, I think, raised our level of encouragement that the triplet is certainly going to be the best opportunity for patients.
With regards to the interaction studies in that context, we haven't seen any sort of drug-drug interactions on that perspective, but these are typical that you do just on some basic pharmacokinetics up front.
[Operator Instructions] Our next question comes from the line of Nicholas Abbott with BMO Capital Markets.
Nicholas Abbott - BMO Capital Markets
I believe, during Baxter's call, when they were discussing HyQ, they indicated that they were actually conducting preclinical studies with Halozyme in a couple of animal models, a rat model and a rabbit model; data by the end of the year but with interim data being discussed during the first half of the year. Can you provide more detail on what exactly it is that's being looked at in those models, the time cost and what the interim data would be as opposed to the final data?
Yes, certainly. I mean, as far as the actual studies, as we've kind of mentioned over the past, there's a general analysis done of all the safety assessments that were quite extensive for the molecule itself. And some additional studies were done to characterize the relevance of those models with regard to safety of non-neutralizing anti-drug antibodies. So we've gone through and have done a thorough analysis of the prior studies, a lot of scientists gone into that in far more detail than I could probably go into a call today.
As far as the additional studies that have been looked at, there's been essentially some ancillary studies put in place that we think are supportive specifically to address this product. So I think that it's still, I think, early to go through and call where this kind of all comes together on it. But I think that the folks scientifically have been incredibly rigorous and have taken this very seriously to go through and really not leave any stone unturned. So I can't kind of speculate from a time frame on those. I think that you'll probably want to wait for, I think, Baxter to have a meeting with FDA to go through and kind of talk about the -- how those fit in the entire picture.
Nicholas Abbott - BMO Capital Markets
So just a quick follow-up. So you can -- in these animal models then you can develop non-neutralizing antibodies and avoid neutralizing antibodies? How do you avoid neutralizing antibody development?
We've done -- boy, I mean, we have everything from human transgenic mice to lots of analysis of doing epitope mapping and a whole host of these. So you look at them from a relevance as far as in the endogenous species, as far as what their activity is. And usually, in most of these cases, you use those that are neutralizing just from the benefit of where you're trying to, in essence, break tolerance and do this for a worst-case scenario. So most of these, as well as looking at animals that have been genetically knocked out and things of that nature. So from that perspective, there's a lot of detail from that perspective down to where things bind and characterization of that nature and transfer during pregnancy, all sorts of things.
Our next question comes from the line of Greg Wade with Wedbush Securities.
Gregory Wade - Wedbush Securities Inc.
Kurt, with respect to the driving to cash flow positive in 2014, what goes into the equation to get there? Can you get there with just Hylenex and MabThera royalties? Or do you need either HyQvia or subcu Herceptin to achieve that?
Well, I would say that our base model is -- assumes that we get revenue associated with Hylenex, as well as Herceptin and MabThera. But I think, as you know, Greg, we've got multiple partnership programs that are out there. And many of these are on significant products. So it's really then just a function of timing as far as when you hit it. So do you need one versus the other? If one of those were to fall away, the others can still drive you to that cash flow positive and then maybe just adjust the timing slightly.
Gregory Wade - Wedbush Securities Inc.
Okay, great. If I just may have a quick follow-up with respect to PEGPH20. Greg, what type of companion tests are you considering in the development plan? Are these biopsy, imaging, blood? Just give us some little insight there. Then secondly, with respect to expression of hyaluronan, is that seen typically in primaries and then the metastatic disease is concordant, also displaying that characteristic? Or is it spotty in terms of whether the primary has it and then the mets may or may not express that?
Sure. All right, let me -- just to start with the first as far as the methodologies. We actually had a number of methods in place even before we went into first in human testing. And we take a general approach, which is obviously for oncology development, companion diagnostics or something that you can't kind of do after the facts. So we actually took an initial approach, which was honing in on everything from imaging, plasma, as well as tissue biopsy-based analyses. And we've honed ourselves in on something that has been working very well in paraffin-based core biopsies. So with regards to your second question about relevance of the primary versus the met because this is, I think, to your point, there's been a lot of questions to this regard, which is when a cancer picks up and goes to a new home, does it still carry along that same microenvironment? And so we’ve done certain studies in malignancies where we've actually looked at that very carefully between even things -- collaboration that we have looking, for example, in breast with the primary versus brain metastases that are obtained. And in that case, you find that it is a very nice correlation. But in the case of pancreatic cancer, we focus most of our efforts on liver biopsies. In some cases, you have primary tissue. But most of the work has actually been on liver metastatic biopsies because they're most readily taken by patients in a non-invasive away relative to getting into the primary that can be tough for patients to do. And what we've seen so far is that, that has been correlating very well and the response you see in the, for example, liver lesions very representative to what we've seen in the primaries. So that was a -- is an important question asked up front for us, but we have, I think, enough primary and metastatic lesions on that to feel good that the correlation is high.
Gregory Wade - Wedbush Securities Inc.
Okay. If I just might ask one last question then, with respect to the apparent imbalance in deaths with the publication of the Herceptin data in the Lancet article, can you just maybe comment on what you think is going on there? And if the results of SafeHer are necessary to get across the finish line, when would that study be sufficiently mature as to counter what appears to be a sort of spurious observation with respect to this acute mortality?
Yes, I mean, I've been getting down to a particular element like that, Greg, number 1, this is obviously Roche's file and they've not discussed the nature of any of the elements going on right now from the standpoint of any discussions. So I don't think I can provide you much more detail than what's already published there or relevant, for example, to ongoing studies. So as I mentioned, I think the results, obviously, the HannaH trial, are published but this would be the type of question to be better posed I think, to Roche.
Our next question comes from the line of Chris Geston with UBS.
Chris Geston - UBS
On the insulin pump, and I apologize if I'm missing this, was there any additional guidance or detail that you were giving in terms of the process, the cost of and timing to launch?
Chris, as far as the details on the pump opportunity right now, the nearest thing that folks will see it coming up, obviously, are some of the Phase IV studies that we're putting in place. And so those are things that you should see coming up beyond clinicaltrials.gov shortly. As far as the other elements, there's really just 3 things that we're getting into right now and that is as far as some ancillary infusion set solutions to make sure those are available. We do have some things that we're doing of getting to a newer high-speed fill line, which is really necessary as far as on supply to ensure you can support the market. And then, of course, these Phase IV studies. So as we put all those together, I can tell you all of those are tracking for us well and the way that we're thinking about this is simply that we think revenue for the Hylenex brand should be significantly contributing to revenue growth for us by the end of 2014.
Chris Geston - UBS
Okay. But again, on the Phase IV, there's been no discussion of trial length, correct?
No, I mean, you'll see that coming up on clinicaltrials.gov and I think I don't -- we haven't mentioned as far as primary endpoint on that, but we'll certainly go through and we'll get some additional commentary on that when it's populated.
Chris Geston - UBS
Fair enough. And if I may with one follow-up. On the PEGPH20, with the shift, I guess I'm not clear on what the road looks like versus what it was prior to this. What is this that you back in terms of time and effort and possibly money? Is that fair at this point or is it too early?
Well, I think actually there's actually a positive element. We were essentially, with the doublet study, we had studies going on both in Europe and in the U.S. And effectively, as you look at the IMPACT data, which it certainly, I think, leaves a lot of room for improvement in an efficacy perspective. But as we look at it, in the U.S., certainly, it would be unethical to run a trial, I think, at this point with gemcitabine alone as a comparator. So when you want to get into that comparator arm, you really need to have a standard of care that allows the investigators to have equipoise and randomization. So timeline-wise, when we look at this, the positive is, while obviously from the time frame, you're going to -- you lose about 4 to 6 months from the shift over at the protocol. The advantage is that we think it will actually enroll much faster. And now we're looking at a study that we're going to do exclusively in the United States rather than doing -- blended between Europe and the U.S. So from that perspective, you may end up winning I think, on the back end, but most importantly, you'll be comparing it to something that's most clinically relevant.
Mr. 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, operator. This concludes today's conference call. Thank you very much for joining us, and you may disconnect your lines at this time.
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