Halozyme Therapeutics' (HALO) CEO Helen Torley on Q2 2016 Results - Earnings Call Transcript

| About: Halozyme Therapeutics, (HALO)
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Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q2 2016 Earnings Conference Call August 9, 2016 4:30 PM ET


Jim Mazzola - Vice President, Corporate Communication and Investor Relations

Helen Torley - President and Chief Executive Officer

Laurie Stelzer - Senior Vice President and Chief Financial Officer

Athena Countouriotis - Senior Vice President and Chief Medical Officer


Jim Birchenough - Wells Fargo

Charles Duncan - Piper Jaffray

Arlinda Lee - Canaccord

Jason Butler - JMP Securities


Good afternoon and welcome to Halozyme Therapeutics Second Quarter 2016 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 call is being recorded.

It is now my pleasure to introduce your host, Jim Mazzola, Vice President of Investor Relations at Halozyme. Mr. Mazzola, you may begin your conference.

Jim Mazzola

Thank you, Samantha, and good afternoon, everyone. Welcome to Halozyme’s second quarter 2016 financial results conference call. Following market close today, we issued a news release with the summary of our results and posted a short Slide presentation to accompany this call. You will find both at the Investors page at halozyme.com.

Leading our call today is Halozyme’s President and Chief Executive Office, Dr. Helen Torley, who will provide an overview and update on our business. Then Laurie Stelzer, our Chief Financial Officer will review financial results for the June quarter followed by a Q&A period. Also with us for today’s call is Dr. Athena Countouriotis, our Chief Medical Officer.

Before we begin, let me remind you that during this conference call, we will be make 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 risks, please refer to our quarterly and annual filings with the Securities and Exchange Commission.

Now, let me turn the call over to Helen.

Helen Torley

Good afternoon and thank you for joining us today. I would like to begin the call with the key takeaways for the quarter. Firstly, we continue to make strong progress across our clinical development program for PEGPH20. Highlights include, presenting key safety and efficacy data from Stage I of our HALO-202 study in metastatic pancreatic cancer patients in June at the American Society of Clinical Oncology Annual Conference.

We made progress with our Phase III pancreatic cancer study HALO-301, initiating sites in the United States, Europe and Australia during the quarter. We were also excited to announce the dosing of the first patient in our Phase Ib/II clinical collaboration with Eisai in women with metastatic breast cancer. And finally, we resumed patient enrollment and dosing in our Phase I/b trial with KEYTRUDA or pembrolizumab in relapsed advanced lung and gastric cancer patients.

Secondly, our ENHANZE platform continues to build value through expansion into new countries, indications and patient population. In recent weeks, the pediatric indication of HYQVIA was commercially launched in Europe, marking the first ENHANZE product approved in a pediatric indication. And Roche’s MabThera SC was approved by the European Medicines Agency for patients with chronic lymphocytic leukemia.

And as a third highlight, due to the strong performance, we have increased our full year revenue guidance to be in the range of $140 million to $150 million from the prior range of $130 million to $145 million. This is primarily driven by higher projected API sales and royalty revenues from our ENHANZE platform.

On royalty revenues, we have experienced strong year-on-year growth of 92% from the second quarter of 2015 due to the expansion of the Herceptin SC and MabThera SC into new countries with growing conversion from IV to subcutaneous administration using our ENHANZE technology.

For additional details of our progress, I’ll start in Slide two with an overview of our strategy. We operate the business and make investment decisions in two strategic pillars. The first pillar is our oncology business with investigational drug PEGPH20 at the core. PEGPH20 temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body that can accumulate around certain tumors and constrict the tumor vasculature. In an animal model, we demonstrated that degrading hyaluronan or HA reduces tumor pressure, increasing blood flow and thereby the access of cancer treatments into the tumor.

Our work in oncology is funded in part by the second pillar of our strategy, which is centered on our licensing agreements with marquee partners including Roche, Baxalta, Pfizer, Janssen and AbbVie and Eli Lilly. These partnerships deliver more than $100 million in annual revenues, differentiating our business model and helping to fund our aspirations in oncology. Both ENHANZE and PEGPH20 are based on our proprietary rUpH20 enzyme.

Now let me begin by providing some additional details on PEGPH20. We have progressed along in our study of PEGPH20 in pancreatic cancer and shared data from Stage I of HALO-202 study during the American Society of Clinical Oncology Annual Conference in June. The presentation included key efficacy and safety data from the final data analysis with an additional 14 months of patient follow up from the previous interim data set.

Turning to Slide 4, we analyze the data using the companion diagnostic which we developed with Ventana to identify patients with high levels of HA. From this analysis, we have reported median progression-free survival of 9.2 months for HA high patients treated with PEGPH20, gemcitabine and ABRAXANE or nab-paclitaxel, also known as the PAG arm of the study.

This compares to six months for HA high patients treated with ABRAXANE and gemcitabine alone or the AG arm. Further, we reported a hazard ratio of 0.46 supporting our Phase III design, which is a progression-free survival as one of the two primary endpoint.

Moving on to Phase II of the HALO-202 clinic trial, we remain blinded to the overall efficacy and continue to project the mature response rate and progression free survival data will be available in the fourth quarter of this year. A total of 133 patients were randomized into Stage II and we estimate 35% to 40% of those patients will be determined retrospectively to have high levels of HA.

The key objective of Phase II is to test the effectiveness of prophylactic enoxaparin to reduce thromboembolic events in the PEGPH20 treatment arm. It is also our plan to analyze efficacy in patients with high levels of HA based on the [cross-sell] (Ph) established with Ventana companion diagnostics.

While we look forward to sharing the Stage II results in the coming months, we are making good progress with our Phase III study shown on Slide 5. HALO-301 is designed and powered to evaluate progression free survival and overall survival in HA high patients. The study is a 420 patient global double blind placebo controlled randomized trial of patients with Stage IV pancreatic ductal adenocarcinoma prospectively identified and included based on high levels of HA.

We are proceeding in this study with two primary endpoints, progression free survival and overall survival and plan to conduct an interim analysis from the target number of progression free survival events reached.

Based on the interim analysis, the Data Monitoring Committee will have the option to recommend we stop the study based on efficacy, continue it to the target enrollment of 420 patients, increase enrollment to up to 570 patients for the final overall survival assessment or stop the study for futility.

If the progression free survival data shows a significant benefits in the PEGPH20 treatment arm and both the overall survival and overall risk benefit are supportive, these data may form the basis for our marketing application in the United States and a conditional marketing authorization in Europe.

Approximately 200 sites in 20 countries have agreed to participate in the study and multiple sites initiations are taking place each week across the United States, Europe and Australia towards our goal of activating approximately 90% of our clinical sites by the end of the year.

We intend to provide periodic updates upon achievement of key milestones including when the target number of US and rest of world sites are ready to screen patients. And in addition to our study in pancreatic cancer, our preclinical model support the potential for PEGPH20 in a broad range of solid tumors and it is our goal to demonstrate this pan-tumor potential.

Turning to Slide 6, I would now like to provide an update on our clinical development programs. After careful consideration on how best to develop PEGPH20 in advanced non-small cell lung cancer given the evolving standard of care, we have made the decision to discontinue further enrollment in the PRIMAL study and to initiate closure activities for that trial.

While this was not an easy decision to make, the rapidly evolving standard of care for patients with non-small cell lung cancer has resulted in the use of docetaxel as a later line therapy.

In turn, this has made it difficult to execute the study as originally designed and to test the underlying research hypothesis. We are in the process of notifying sites and will then collect data and clean the database.

We intend to analyze and present the full dataset from the dose escalation all-comer population of the study at a scientific forum in the next 12 months. I just like to end by thanking both the investigators and the patients who participated in this trial.

And in conjunction with this decision and consistent with the evolving standard of care, we are focusing our efforts in non-small cell lung cancer in our ongoing Phase Ib study of PEGPH20 in combination with KEYTRUDA.

We believe the data we plan to generate in the combination with KEYTRUDA support an appropriate focus for patients and for our investments in the clinical development of PEGPH20.

Moving to our KEYTRUDA study, we recently announced that we resumed patients enrollment and dosing under revised clinical protocol. The revised protocol has been submitted to all institutional review boards and is pending feedback from the FDA.

We intend to share the full amendment once it’s approved by the FDA, but examples of changes include administering a lower dose of low-molecular-weight heparin and modifying some of the inclusion and exclusion criteria.

As a brief reminder, the prior leading events that prompted the changes to the protocol were not classified as dose limiting toxicities nor determined by investigators to be related to PEGPH20. We project that the study will move into the dose expansion by the end of this year pending FDA feedback.

And finally, we have our Phase Ib/II clinical trial with our collaboration partner Eisai. As previously announced, Eisai dosed their first metastatic breast cancer patient in this study in July. The primary objective of this trial are to determine the safety, tolerability and recommended dose of PEGPH20 in combination with eribulin mesylate in the Phase Ib portion and to determine the objective response rate of the combination compared to eribulin alone in the Phase II portion of the trial.

We look forward to updating you on progress in the coming months. And in addition to ongoing development of PEGPH20, I like to provide brief highlights on our two pre-clinical programs, which were presented for the first time in April.

A summary of the first program is shown on Slide 8. An immune checkpoint inhibitor targeting adenosine which we call PEG-ADA2. We are encouraged by investments being made in the industry towards this target and believe our program is on the forefront as the only checkpoint inhibitor to enzymatically deplete adenosine.

Our research supports this as a differentiated mechanism of action, as compared to other early stage therapies targeting the adenosine check point. This program remains in lead optimization, with the goal of identifying a candidate module for development by the end of 2016, allowing key CMC development activities and IND enabling toxicology studies to support first in human testing to begin in 2017.

The second pipeline program is shown in Slide 9 and it’s called HTI-1511, a novel antibody drug conjugate or ADC targeting Epidermal Growth Factor Receptor or EGFR that may bypass downstream activating mutations. In preclinical studies, HDI-1511 has demonstrated tumor growth inhibition or regression in colon, lung and cholangiocarcinoma animal models.

CMC development activities are ongoing and initial toxicology studies are planned for 2017 to support an IND filing in the first half of 2018. We look forward to updating you at future scientific fora as we make progress in these programs.

Let me now move to the second pillar of our strategy, producing ENHANZE platform. The value proposition of ENHANZE is shown on Slide 11 and includes life cycle management with the opportunity to prolong the exclusivity period for the combined product and the ability to reduce dosing frequency and duration by taking drugs from an IV to subcutaneous formulation or allowing higher volumes to be infused at one time.

Turning to Slide 12, we currently have six marquee partners generating milestone revenue, three approved products generating royalty revenue with two new indication approvals just in the last quarter, For access on one recently completed Phase I study and one Phase III study in the clinic. All of these have the potential to generate future milestone and royalty revenue for the Company.

The Phase I trials currently in the clinic include Janssen’s anti-CD38 daratumumab for multiple myeloma patients, AbbVie HUMIRA to help reduce the number of induction injections at higher doses, Pfizer’s Phase I trial evaluating the safety, tolerability and pharmacokinetic of bococizumab, an investigational PCSK9 inhibitor and Roche’s study of Perjeta in HER2-positive breast cancer patients.

During the second quarter, Pfizer completed the in-life portion of a single and multiple dose Phase I assessment of rivipansel with our enhanced technology. Initial analysis of the data has demonstrated feasibility of large volume subcutaneous administration with our EPH-20 and Pfizer will determine the next steps for this program.

On Slide 13 are the summary of the key deal terms for our six enhanced collaboration agreements, where you see a mid-single digit royalty and net sales for all commercialized products as well as milestone payments based on development and commercial progress. As you can note, the potential for milestones has increased substantially for recent deals as we have seen regulatory approvals from both the FDA and European Medicines Agency and commercial validation through the strong launch uptake in sales of subcutaneous products using our enhanced technology.

Now turning to an update on Roche, which is on Slide 14. As Roche indicated during the most recent quarterly call, Herceptin SC now accounts for approximately 47% of total Herceptin sales and approximately 15 countries with a number of those countries enjoying above 70% market share.

MabThera SC is now available in 16 countries and excluding Spain where it was most recently launched, accounts for 34% of total MabThera sales in those countries. We are also pleased with Roche’s recent announcement that they received approval for MabThera SC from the European Medicines Agency for patients with previously untreated chronic lymphocytic leukemia or CLL. With a strong commercial performance and ongoing growth potential through new country approval and the approval of the new indication, we are very pleased indeed with the ongoing success of the Roche programs.

Moving now to HyQvia, our third marketed product, as SHAR announced last month, a pediatric indication of HyQvia was approved by the European Medicines Agency in May and subsequently launched in eight European countries. SHAR estimates that as many as $6 million children and adults may be affected by primary immune deficiencies worldwide.

Additionally, after receiving orphan drug designation for HyQvia for the treatment of Chronic Inflammatory demyelinating polyneuropathy or CIDP in the first quarter of 2016, a Phase III trial was initiated to explore patient for treatment in patients with this disease.

In closing, I’m very pleased with the continued progress of all of our enhanced platform both commercially and in the clinic. We see clear opportunities for continued growth through new collaborations, and as we support our current partners in advancing their programs.

With that, I’ll now turn the call over to Laurie to discuss the financial results for the second quarter in greater detail. Laurie.

Laurie Stelzer

Thank you, Helen. I will begin on Slide 16 where you will see that revenues for the second quarter was $33.3 million compared to $43.4 million in the prior year period. Recall in the second quarter of 2015. We signed our collaboration agreement with AbbVie and received $23 million upfront payment. Excluding that payment, revenue growth was strong at 64% year-on-year.

During the second quarter, royalty revenue totaled $12.3 million, an increase of 8% sequentially from last quarter and nearly double the royalty revenue from the second quarter of 2015. This increase came largely from higher sales of Roche’s Herceptin SC during the first quarter of 2016. Bulk sales of rHUPH20 totaled $9.5 million. Hylenex product sales totaled $4.2 million, and other collaboration revenue totaled $7.4 million, which included reimbursement for R&D services from our partners.

Turning to Slide 17 for a more detailed breakdown of our P&L, cost of product sales was $8.3 million in the quarter compared to $8.1 million in the prior year period. Research and development expenses for the second quarter was $35.5 million compared to $21.2 million for the second quarter of 2015.

This planned increase was primarily due to a ramp in spend associated with that HALO-301 study, investments and other studies to explore the pan-tumor potential of PEGPH20 and manufacturing and clinical supply expenses that are reimbursed by our enhanced partners.

Selling, general and administrative expenses were $11.2 million compared to $9.8 million for the second quarter of 2015. The increase was primarily due to personnel expenses, including stock-based compensation for the period. In total, our operating expenses increased by $15.9 million from the second quarter of 2015.

Net loss for the quarter was $26.9 million or $0.21 per share compared to operating income of $3 million or $0.02 per share in the second quarter of 2015 driven by the upfront payment of $23 million from AbbVie in 2015 as well as lower R&D spend in the prior year period.

Cash, cash equivalents and marketable securities were $230 million at June 30, 2016, compared to $238.6 million at March 31, 2016 and $140.7 million in the second quarter of last year. Through the previously announced debt refinancing with Oxford Finance in Silicon Valley Bank completed in June, adding $22 million to our expected cash balances in 2016 and 2017. We continue to remain well capitalized for our 2016 plans and into 2017.

Finally, I would like to provide an update on our financial guidance for 2016 as shown on Slide 18. For the full year, we have increased our revenue guidance to a range of $140 million to $150 million to reflect higher projected ATI sales and royalty revenues from our ENHANZE platform.

We continue to expect operating expenses to be in the range of $245 million to $260 million. As announced on June 8 when we completed the debt refinancing, we expect our year-end cash balance to be in the range of $170 million to $190 million and as a result, our cash flow to be in the range of $65 million to $85 million, an increase from the range announced on our Q1 earnings call of $45 million to $65 million.

With that, let me turn the call back to Helen, who will provide closing comments.

Helen Torley

Thank you Laurie. In summary, we continue to make progress across both pillars of our strategy during the second quarter, in the PEGPH20 we are well underway now with global cite initiations for our Phase III study. We received our KEYTRUDA trial and relapsed lung and gastric cancer patients and we initiated our collaborative study with Eisai in patients with metastatic breast cancer.

And on the EHANZE pillar, we continue to drive value through growing royalty revenues, the expansion of our marketed products into new countries, patient populations and indications and through the progress of our five partnered products in the clinic. We are confident in the investments we are making in both pillars, we are generating near and longer-term value for our shareholders and partners.

And as ever, I just want to close by expressing my gratitude and appreciation to our talented Halozyme team and their continued hard work in advancing our programs and in support of our partners.

We are now ready to take your questions? Operator, please would you open the call.

Question-and-Answer Session


Thank you. We will now be conducting a question-and-answer session. [Operator Instructions]. Our first question will come from Jim Birchenough with Wells Fargo.

Jim Birchenough

Hi guys. Thanks for the update. I guess a couple of questions, just starting with PRIMAL, beyond stringent standard of care, was there any data that you saw either on the efficacy side or the safety side that conflict the decision here?

Helen Torley

Jim, its Helen here. Really it was the evolving standard of care. I think it’s very clear that, that was resulting in docetaxel moving later and later in the lines of therapy, and we were just simply unable to execute the study as we originally planned and tell the hypothesis. So that was the reason we elected to stop the PRIMAL study.

Jim Birchenough

And then just a bit of high [technical difficulty] it sounds that the cash you have at year-end, how far along does that take you? Does it just take you at through 2017 or will that get you to 2018 and substantially through the pancreatic cancer.

Laurie Stelze

The cash will take us well into 2017 and as you know, with our business model, our cash flow really depends on the revenue that we earn from our enhanced partners and any new enhanced partnership contains that picture but the cash does take us into 2017.


Thank you. Our next question will come from Charles Duncan with Piper Jaffray.

Charles Duncan

Hi, guys thanks for taking the question and congrats on some good momentum in the ENHANZE side of the business.

Helen Torley

Thanks Charles.

Charles Duncan

So quick question, regarding the upcoming data from 202, the PFS data anticipated in the fourth quarter, I guess, I’m wondering, how would you suggest investors think about that in terms of reading on having any predictive value for 301 or do you see there being significant differences in trial design or whatever that should be kept in mind.

Helen Torley

Let me ask Athena to address that Charles.

Athena Countouriotis

Hi Charles thanks for the question. I think that we are very excited to see the stage today and obviously share both the response rate and progression-free survival in Q4. We do believe at that time that survival will not be mature, so it is our anticipation that we’ll be sharing that next year but really the read through to Phase III, there is really is no difference in regards to the designs with the exception that the Phase III is a much bigger trial and is adequately sized and powered to show a statistical difference in terms of survival as well as a stronger signal for progression free survival.

So again we were very inherently - when we designed the trial to keep Phase II similar to Phase III, but clearly made it a more appropriately sized trial because we do believe that Stage II will still be limited in terms of its size.

Charles Duncan

Okay. That’s helpful. And then with regard to the read out, would you consider making any changes to this 301 protocol, are you pretty well set on that and if the sites are up and running by year-end at about 90% as you hope, what would your projected timelines for 301 to be?

Athena Countouriotis

When we again start with in terms of the timeline projection what we have said is we are going to give more adequate projections once we have hit our ramp in terms of site initiations and it remains our goal to achieve approximately 90% before the end of the year.

To your first point in terms of changes to the Phase III, we are very confident in the design right now based on conversations that we have had with both the FDA and EMA. We are also aware you probably are as well with ASCO guidelines and we do feel that we have adequately designed our trial within those guidelines, and so at this point, we are not anticipating making any changes to the Phase III based on the Phase II data again because it likely is limited in terms of the size.

Charles Duncan

Okay. Very good. Thank you for the added color. Congrats on a good quarter.

Athena Countouriotis

Thank you.


Thank you. Our next question will come from Jessica Fye with JPMorgan.

Unidentified Analyst

Hi This is [indiscernible] on the call for Jessica. Thank you for taking our questions. Regarding the combo trials with KEYTRUDA when could we potentially see the initial data from the trial and what data could we see in the initial look.

Helen Torley

Yes this is Hele. Just to say, with regard to the KEYTRUDA study, our intention is, as I mentioned during the prepared remarks and I hope pending FDA feedback to move into the dose expansion portion in the second half of this year and that’s important because the dose expansion portion is going to be the section where we are selecting patients for high HA and testing at the Phase II dose.

So in terms of timing for data, that certainly would put us beyond 2016 for data and exactly when we’ll depend on the rate of enrollment and when exactly we enter the expansion phase, but we certainly are pleased with the interest we are seeing in this study and look forward to providing further updates once we have moved into the dose expansion efficacy portion of the study.

Unidentified Analyst

Great. Thank you.


Thank you. Our next question will come from Arlinda Lee with Canaccord.

Arlinda Lee

Hi guys. Thanks for taking my question. I just wanted to follow-up on the question earlier on the panel discontinuation. Can you clarify whether you have seen any efficacy or safety data from that? And then secondly, we noticed on the Roche Slide that there is a reference to subcutaneous Mabthera, it says that filing in the US is spending. Can you please clarify what that means.

Athena Countouriotis

Yes. Let me take the one on PRIMAL first. We have - we are doing it at this point in time as I mentioned in the prepared remarks is informing the investigators that we are closing the study. That will initiate a process of data collection and cleaning and that’s really when we are going to get a look at the efficacy and safety data in a closed data base. So we are going to wait until that point in time obviously to know what the data shows.

With regard to the Roche Slide, we certainly did see that Slide as well and that all we can say is, indeed, they did include a Slide that said that Mabthera SC was pending in the US for CLL, but we have no additional information or comments. And if you do have additional questions, you’d have to refer them to Roche.

Arlinda Lee

So have they filed in the U.S.?

Athena Countouriotis

Again, as you know, Arlinda, with terms of our agreements, we are really only in a position to repeat comments that our partners have made and that’s the only information that is public at this point in time. So we can’t say anything more than that.

Arlinda Lee

Okay. Great, thanks.


Thank you. Our next question will come from Jason Butler with JMP Securities.

Jason Butler

Hi. Thanks for taking my questions. Just a quick follow-up on the Phase II data related this year and the Phase III trial. Is there any opportunity for a samp size adjustment based on your read of the Phase II results?

Helen Torley

Yes. Jason, let me ask Athena just to address that.

Athena Countouriotis

Hello, Jason, as I said, earlier to Charles’ question, it is not our anticipation that we will be making modifications to the Phase III. We do have confidence in the current design and we do appreciate that the Stage II data will likely be a small sample size. Having said that, we can always make modifications. We have active dialogue with the FDA on an ongoing basis. So that is always an option but were not something that we are anticipating now based on our confidence in the Phase III current design.

Jason Butler

Okay, great. And then on the PRIMAL study, are you able to give us, even a rough ballpark estimate of how many patients will be ultimately enrolled in the trial or have been enrolled in the trial? And what maturity of data we might ultimately see? Are we really talking about response rate data? And is there any estimate of what the duration might be?

Helen Torley

Yes. Let me ask Athena to give a little color on how many patients for enroll?

Athena Countouriotis

Sure. So we enrolled, remember, this is the all-comer population in dose escalation so we were not testing for HA high biopsy information. Having said that, we dosed across three dosing cohorts, a total of 16 patients. I’m sorry, go ahead.

Jason Butler

Okay. Great. That’s helpful.

Athena Countouriotis

Sorry. Go ahead.

Jason Butler

No, that’s helpful. Just in terms of the data we might see, is it really just response rate data? Is that fair to assume?

Athena Countouriotis

Yes. I mean, again, I think what we will focus on obviously since there was dose escalation is safety and tolerability. And I think as Helen mentioned, this trial was stopped because of the rapidly change in standard of care and we were starting to see a trend of third, fourth and fifth line patients where that were being enrolled in this trial. So from an efficacy perspective, as we continue to clean the data, I would anticipate that, that is what likely you are going to see as response rate data.

Jason Butler

Okay, great. Thanks for taking the questions.

Helen Torley

Thanks Jason.


Thank you. Our next question will come from Jim Birchenough with Wells Fargo.

Jim Birchenough

Just a couple of follow-ups just to clarify. So in terms of the Stage II data we are going to go, are we going to get positive ratios for progression-free survival? And is there any hazard ratio that might prompt the change in the 301 setting?

Helen Torley

Yes, let me ask Athena to address that.

Athena Countouriotis

Hey Jim. We will plan on sharing in the Q4 time frame, that’s our projection. Mature, response rate data and progression free survival data in the HA high population, at least, and that would include median and hazard ratios. It’s too early to predict if we would have anything else besides that. Again, it is our anticipation that we won’t have mature survival data prior to the end of the year. And as I said, we are not planning for it but we believe it is in the best interest of the study and in patients’ best interest. We will discuss with the FDA the results and potentially modify the trial.

Jim Birchenough

And then just maybe on the financial side, are you able to break down the spend if you look at your OpEx and allocated between PEGPH20 and other programs. What is the distribution spend right now?

Helen Torley

Jim, I’ll ask Laurie to address that.

Laurie Stelze

It’s a great question. We haven’t given that level of break out but I would say the majority of our spend is PEGPH20 related and as you might expect.

Jim Birchenough

And then just the final one, I know in the past Helen you talked about prospects for additional collaborations. Do you have any goals internally in terms of productivity of ENHANZE in terms of attracting additional partnerships? Anything we should think about as we look out over the next 12 months?

Athena Countouriotis

Yes, thanks. We certainly have a team who are dedicated and active in seeking new ENHANZE collaborations. The challenge is always knowing exactly when those are going to come to fruition. So we do have internal goals for it and we continue to work to seek new partners. We believe there are still a large number of molecules out there that would potentially benefit from PEGPH20. But we will obviously let you know when we have closed those deals, but it’s a strong focus of the team.

And as you saw from the Slide I added in the deck, we also, with the collaborations that we have signed, see significant potential by moving the current partners and supporting them in moving their products through the clinic because they are associated with milestones for progress in development also commercial. And so you see us working in both of those avenues for continued growth of ENHANZE.

Jim Birchenough

Okay. Well, thanks for taking the follow-up.


Thank you. [Operator Instructions] Our next question will come from Charles Duncan with Piper Jaffray.

Charles Duncan

Hi guys thanks for taking the follow-up. Quick question on the ENHANZE side of the business. I’m wondering if you can project any potential milestone related revenues over the course of, say, the next 12 to 18 months or you are really just counting on royalty-based revenues over the course of that time?

Helen Torley

Let me ask Laurie to address that.

Laurie Stelze

Hi. We do look at the partners that we have currently contracted with and the programs that they have in the pipeline, and we do forecast milestones based on the programs that we have line of sight to. But we do not forecast for new partnerships or any new programs that have not yet been announced.

Charles Duncan

It’s helpful. Thanks Laurie. The other question I had on the ENHANZE side of the business, is the core IP, if you could just remind me I spent several years since I did that diligence. But how long, what is the life, I guess, the lifespan of the core IP that underlies these ENHANZE partnerships.

Helen Torley

So the rHuPH20 for a composition of the matter is 2024 in Europe and 2027 in the US. Activities are underway and it is our strong belief that we are going to see opportunities to extend the exclusivity significantly beyond those dates. So we do continue to have a strong intellectual property around rHuPH20 platform.

Q - Charles Duncan1

Thanks Laurie for the color.

A - Laurie Stelzer

Thanks Carl.


[Operator Instructions]

Jim Mazzola

And operator, if there are no further questions, we can probably wrap up the call.


Okay, sir. Dr. Torley, there are no further questions in the queue at this time. I would like to turn the floor back over to you for closing remarks.

Helen Torley

That’s great. Thank you, everyone. We appreciate you joining us today. As you can see continued strong momentum on both arms of our pillars here at Halozyme. So thank you for your ongoing interest and support in the Company. Thank you. Good-bye.

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