Halozyme Therapeutics Inc (HALO) 2015 Q2 法說會逐字稿

Good afternoon and welcome to Halozyme Therapeutics' second-quarter 2015 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 of Investor Relations and Strategy at Halozyme Therapeutics.

Mr. Greenway, you may begin your conference.

Thank you, Operator.

Good afternoon everyone, and welcome to Halozyme's second-quarter 2015 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. Following Helen, Laurie Stelzer, our Chief Financial Officer, will review our financial results. Helen will then issue some closing remarks, after which we will open the call to your questions.

Also participating on today's call is Dr. Athena Countouriotis, our Chief Medical Officer, and Jim Mazzola, our Vice President of Corporate Communications and Investor Relations. We also posted slides to accompany today's webcast, which may be found on the Investors section of our website, along with our earnings materials.

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.

Thank you, Schond.

Good afternoon, everyone, and thank you for joining us today. It is a pleasure to update you on our recent progress. I'm going to begin with a review of our strategy and the progress we've made against it during the quarter. Then Laurie will cover our financial results in greater detail before we take your questions.

The second quarter was marked with strong execution on both sides of our two-pillar strategy. The first pillar is our Oncology business with our investigational drug, PEGPH20, at its core. We are currently studying PEGPH20 in pancreatic and non-small cell lung cancer. But we see broader potential applicability for its use in multiple tumor types in combination with immuno oncology agents, monoclonal antibodies, and chemotherapies. We took another step forward in this pan-tumor strategy with the recently-announced Eisai collaboration and with our plan to take PEGPH20 plus pembrolizumab study, where we have extended the study design to also include relapsed and refractory gastric cancer patients.

Our work in oncology is funded in part by the second pillar in our strategy, which is centered on our licensing agreements with marquee partners including Roche, Baxalta, Pfizer, Janssen and now AbbVie. These partners co-formulate or co-administer their therapies with our enhanced technology, to introduce subcutaneous dosage forms, as is the case with Herceptin SC and MabThera SC, or change the frequency or the number of injections required, an example of which is HYQVIA.

Our revenue is driven by the second pillar, and we're pleased to report $43.4 million in revenue for the second quarter, a year-over-year increase of approximately 136%. Revenues in the second quarter included a one-time upfront payment of $23 million from AbbVie. Royalty revenue for the quarter was $6.4 million, reflecting predominantly Herceptin SC sales in January, February, and March of 2015.

With that brief overview, let me now provide a more comprehensive update on our progress in our oncology pillar. Our vision at Halozyme is to establish PEGPH20 as a backbone therapy across multiple oncology indications, in combination with a broad range of cancer therapies. Our current and future clinical programs target a range of solid tumors where there is a high accumulation of hyaluronan, or HA, the presence of which can block access of cancer therapies to the tumor. PEGPH20 works by degrading HA with the goal of improving access of the co-administered therapy.

Let me now provide an update on our pancreatic cancer program, beginning on slide 5. Study 202 is our ongoing Phase 2 trial in metastatic pancreatic ductal adenocarcinoma patients. In an oral presentation at the American Society of Clinical Oncology annual meeting in May, we presented interim findings from the study evaluating PEGPH20 plus ABRAXANE and gemcitabine, versus ABRAXANE and gemcitabine alone. Data from Stage 1 are summarized on slides 6, 7, and 8, and show that in high-HA patients, receiving PEGPH20 in addition to ABRAXANE and gemcitabine, there was a more than doubling of progression-free survival, response rate, and duration of response compared to patients receiving ABRAXANE and gemcitabine alone.

On slide 8, the interim data also showed a trend towards improvement in median overall survival in high-HA patients, with a median overall survival of 12 months in the PEGPH20, ABRAXANE and gemcitabine arm, compared to nine months in the ABRAXANE and gemcitabine alone arm. The hazard ratio was 0.62, despite discontinuation of PEGPH20 in more than half of the treated patients in this arm of the study at the time of the clinical hold in April 2014.

The potential risk profile was also evaluated and is highlighted on slides 9 and 10. We presented data on the rate of thrombo-embolic, or TE, events in patients treated in Stage 2 of the trial, which began after the protocol amendment in July 2014. This amendment excluded patients at high risk of TE events, and added prophylaxis with a low-molecular-weight heparin, enoxaparin, to all patients in both treatment arms.

Reported results, shown on slide 10, included a TE event rate of 13% in patients treated in the PEGPH20 arm versus 18% in patients receiving ABRAXANE and gemcitabine alone. The changes made to the protocol appear to have decreased the risk of TE events for all patients, an encouraging trend that we will continue to monitor. Our goal is now to complete the enrollment in Study 202 by the end of 2015. And we expect to submit the data from Stage 2 to an appropriate medical conference in 2016.

Turning now to slide 11, I would like to highlight the progress we are making toward the start of our Phase 3 study in pancreatic cancer. During our first-quarter call, I provided an update on our Type B meeting with the FDA, where we discussed the benefit/risk profile of PEGPH20 and our proposed Phase 3 study. It was after that meeting that we announced plans to move forward with the study in previously-untreated metastatic pancreatic cancer patients with high HA, and with progression-free survival and overall survival as two separate primary end points.

During the second quarter, we received scientific advice from the European Medicines Agency, or EMA, on the planned study. The EMA was supportive of the patient population and overall trial design, including evaluating only high-HA patients. While the EMA stated that overall survival is the preferred primary endpoint, they indicated that a conditional marketing authorization, or CMA, could be granted with the current design using PFS as an additional primary endpoint, provided it is supported by at least a trend in overall survival. A CMA will ultimately be based on the evidence to support a positive risk/benefit profile.

Based on the EMA feedback, we plan to proceed with the trial design previously discussed with FDA and continue to target the end of the first quarter of 2016 to initiate the study. We are making good progress toward our target, with the final protocol nearing completion, CRO selection complete, and outreach to potential trial investigators ongoing.

Let me now say a few words on our companion diagnostic. During the quarter, we entered into a partnership with Ventana for the final stages of our companion diagnostic development and commercialization. Ventana is providing the expertise needed to develop this proprietary diagnostic, which will be used to prospectively identify and select patients with high levels of HA, with the goal of identifying the patients we believe are most likely to benefit from PEGPH20 treatment. We are making good progress with Ventana, including transferring our process to Ventana's platform, and refining and validating the staining and scoring methodology.

Summarizing upcoming milestones for our pancreatic cancer program, it is our goal to complete the patient enrollment in Stage 2 of Study 202 by the end of the year. Recall this is an event-driven study with PFS as the primary end point. And it will be our goal to submit this data, when available, to an appropriate scientific meeting in 2016.

Secondly, we plan to finalize the specifications and submit an investigational device exemption for the companion diagnostic. The companion diagnostic will support initiation of patient enrollment in the planned Phase 3 study.

And thirdly, and in parallel, we continue to plan for our global Phase 3 study in metastatic pancreatic cancer, and remain on track to initiate this study at the end of the first quarter of 2016.

Regarding other developments focused on pancreatic cancer, there are a number of initiatives underway with cooperative groups and investigator-sponsored studies seeking to evaluate the use of PEGPH20. The small collaborative research group is conducting a Phase 1b/2 study of PEGPH20 in combination with modified FOLFIRINOX chemotherapy, in patients with metastatic pancreatic adenocarcinoma. The Phase 1b dosing portion has been completed, and enrollment is underway for the Phase 2 portion of the study. Approximately 150 patients will be enrolled at up to 30 sites.

Turning now to an update on our Non-Small Cell Lung Cancer program. Our pre-clinical model supports the potential of PEGPH20 in a broad range of solid tumors. And we selected non-small cell lung cancer as the second tumor setting to explore. The PRIMAL study is designed to evaluate PEGPH20 in combination with docetaxel in locally advanced and metastatic patients who did not respond adequately or lost their response to a platinum-based regimen. The initial Phase 1b portion is designed to evaluate and identify the dose, schedule, and safety of PEGPH20 plus docetaxel.

Our target has been to complete the Phase 1b portion of this study in the third quarter of 2015, pending the number of dose-escalation cohorts required to determine the maximum tolerated dose of PEGPH20. To date, progress through the initial dose-escalation cohort is taking longer than anticipated. Due, we believe, to the initial trial design, which constrained the number of patients we could screen and potentially enroll at the same time. We have also noted an increase in the number of PD-1 and PD-L1 trials in this space, which may also be a contributing factor.

We have recently modified the design of the trial and initiated 5 new sites, bringing the total number of sites to 12. We believe these actions will help us make stronger progress towards completion of this initial portion of the study. We and our key opinion leaders/advisors continue to believe chemotherapy will have a valuable role to play in the treatment of patients who do not respond or do not have a sustained response to immunotherapy. I look forward to providing a further update on our progress after these changes on the November call.

As we refine the PRIMAL study, we are in very good position to adapt to the changing landscape in the treatment of non-small cell lung cancer, with our planned Phase 1b study of PEGPH20 with KEYTRUDA or pembrolizumab. The standard of care in non-small cell lung cancer is changing to now include immunotherapies. And we believe PEGPH20 also has a role to play with the range of emerging treatment options. The PEGPH20 plus pembrolizumab study will enroll relapsed refractory, Stage IIIB/IV non-small cell lung cancer patients, who have been treated with at least one platinum-based regimen. And also enroll relapsed refractory locally advanced or metastatic gastric adenocarcinoma patients, who have failed at least one chemotherapy regimen.

This trial is Halozyme-sponsored and is being conducted at a number of leading oncology centers with KEYTRUDA experience. We have finalized our protocol; selected our CRO; and we are working on clinical site initiation activities. We plan to enroll up to 80 patients in the study at up to 20 clinical sites. And we remain on track to start the study in the second half of 2015.

Now on slide 12, let's discuss our recently-announced clinical collaboration with Eisai. We signed the clinical collaboration agreement that will evaluate HALAVEN, or eribulin, in combination with PEGPH20 in first-line HER2-negative high-HA metastatic breast cancer patients. We estimate that there are between 30,000 and 35,000 patients in the US with this difficult-to-treat cancer. Halozyme and Eisai will co-fund a Phase 1b/2 clinical trial to explore whether HALAVEN in combination with PEGPH20 can improve overall response rate, as compared with HALAVEN alone as a therapy for advanced breast cancer patients.

This is our first clinical collaboration for PEGPH20, and we are excited to work with an experienced leader in the treatment of breast cancer. In our pre-clinical models, we found the addition of PEGPH20 to eribulin showed significantly higher tumor growth inhibition and overall tumor regression when compared to eribulin alone. Eisai's depth of experience in conducting clinical trials in this patient population will enable us to focus on our ongoing Halozyme-sponsored trials, while continuing to expand our research of PEGPH20. I look forward to updating you as we initiate the trial in early 2016.

Let me now switch gears and, in slide 13, provide you with an update on the ENHANZE pillar. Our ENHANZE technology can be used in combination with a variety of other drugs and is applicable across many therapeutic categories. The value proposition we may offer partners and patients includes life cycle management, with the opportunity to prolong the exclusivity period for the combined product, and the ability to reduce dose frequency and duration by taking drugs from an IV to a subcutaneous formulation or allowing higher volumes to be infused at one time.

In their April 2015 update, Roche confirmed that Herceptin SC, which is a subcutaneous co-formulation of Herceptin with our ENHANZE technology, had been launched in 44 markets, with a patient share exceeding 30% in those markets. Herceptin SC helps reduce treatment time for patients, caregivers, and healthcare practitioners, therefore becoming a valuable line extension to the Herceptin franchise.

Roche is in an earlier stage of launching MabThera SC, for the treatment of patients with common forms of non-Hodgkin's lymphoma, including follicular and diffuse large B-cell lymphoma. In Europe, Roche has also announced that it filed MabThera SC for previously-untreated chronic lymphocytic leukemia in the fourth quarter of 2014.

Baxalta's HYQVIA, which was launched in the US in October of 2014, combines Immune Globulin Infusion 10% with our recombinant human hyaluronidase, and is indicated for adults with primary immune deficiency or PID. PID is a chronic condition, and HYQVIA reduces the frequency of infusions, meaning fewer needle sticks for patients, and the possibility of self-administration at home. HYQVIA offers the only once-a-month subcutaneous product for the treatment of adults with PID.

As reported by Baxalta, the US launch of HYQVIA has strong momentum, with approximately 2,300 patients on HYQVIA, representing about 15% of the sub-Q market, the fastest growing segment of PID therapy. Baxalta has reported that about 70% of HYQVIA adoption is coming from competitive therapies and from patients naive to immunoglobulin treatments. This is expected to be a $3 billion market by 2020, with subcutaneous therapies representing more than 50% of the sales. And with the launch now well underway, Baxalta is evaluating additional indications, including plans for a Phase 3 trial later this year in the neurological disorder, chronic inflammatory demyelinating polyradiculoneuropathy.

Turning now to our more recent collaborations for the ENHANZE technology, in June we announced a new global collaboration with AbbVie, where we received a $23 million upfront payment and the potential to earn approximately $130 million in milestones for each of up to nine targets. And in December of 2014, we announced a global ENHANZE collaboration with Janssen. The anti-CD38 antibody, daratumumab, which is being developed under a collaboration between Janssen and Genmab, is the first product candidate under this collaboration. Janssen is planning a Phase 1B study of the subcutaneous formulation of daratumumab in multiple myeloma.

Roche's new product launches and the recent deals with Janssen and AbbVie have continued to stimulate interest in ENHANZE. And we're looking forward to working with our current and future potential partners to create transformative therapies for patients, partners, and for payers.

And with that, I'll now turn the call over to Laurie to discuss our financial results for the quarter in greater detail.

Laurie?

Thank you, Helen.

I'm very pleased to join Halozyme and look forward to meeting many of you at upcoming conferences this fall. Let me jump right into our financial performance in the quarter.

If you turn to slide 15, you will see that revenues for the second quarter of 2015 were $43.4 million, compared to $18.4 million for the second quarter of 2014, driven by the $23 million payment for initiation of our agreement with AbbVie. Revenues in the second quarter included $6.4 million in royalty revenue from sales of products under collaboration agreements; $7.7 million in product sales of bulk rHuPH20 for use in manufacturing collaboration products; $4.2 million in Hylenex product sales; and $24.7 million in collaboration revenues, including the AbbVie payment.

Royalty revenue grew year-over-year approximately 278% to $6.4 million in the second quarter, reflecting partnered product sales in the January to March 2015 period. The key driver of this increase has been the increasing sales of Herceptin SC.

On a sequential basis, we saw a decline of $400,000 in royalty revenue, due to some initial stocking for HYQVIA. Over the next several quarters, royalty revenue will be driven by new country launches and increased conversion in current countries for Herceptin SC and MabThera SC and the uptake in the US of HYQVIA.

Turning to slide 16 for a more detailed breakdown of our P&L, research and development expenses for the second quarter of 2015 were $21.2 million, compared to $18.6 million for the second quarter of 2014. The increase was primarily due to an increase in expenses related to pre-clinical and clinical activities for PEGPH20, offset by a planned decrease in expenses associated with discontinued development programs.

Selling, general and administrative expenses for the second quarter of 2015 were $9.8 million, compared to $8.8 million for the second quarter of 2014. The increase was primarily due to an increase in personnel expenses, including stock compensation for the period.

Net income for the second quarter of 2015 was $3 million, or $0.02 per share, compared to a net loss for the second quarter of 2014 of $16.3 million, or $0.13 per share. Cash, cash equivalents and marketable securities were $140.7 million at June 30, 2015, compared to $128.5 million at March 31, 2015. Net cash increase in the second quarter of 2015 was approximately $12.2 million.

On slide 17, you will find an update to our guidance for 2015. With half the year now reported and the addition of the AbbVie agreement, we now expect net revenues to be in the range of $110 million to $115 million. Operating expenses are now expected to be in the range of $160 million to $170 million. Operating expenses are expected to increase primarily due to the acceleration of a bulk PH20 manufacturing campaign to fulfill current and future orders. And an increase in expenses related to the expansion of the PEGPH20 clinical program from two ongoing trials to five trials. This includes expenses to help assure our readiness for the end of Q1 2016 initiation of the global Phase 3 pancreatic cancer study.

Cash burn is expected to decrease, due to the inflow of new revenue, partially offset by the increased planned expenses. And we expect net cash burn to be between $20 million and $30 million lower than we had previously guided, due to the new revenue inflow and some benefit we are receiving from the proceeds of stock option exercises, which are offset by the increase in spending. Our year-end cash balance is expected to be $105 million to $115 million.

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

Thank you, Laurie.

In closing, as you have just heard, we really did make that strong strategic and operational progress during the quarter. We are moving forward with our plans for our Phase 3 study in previously-untreated metastatic pancreatic cancer patients, following the key end of Phase 2 meeting with the FDA, and now following scientific advice from EMA. We're making additional investments in our oncology franchise, based on our strategy to evaluate how PEGPH20 could benefit patients with a range of different tumor types. And we continue to see the value of our enhanced technology demonstrated through the positive results of our partners.

Some of the key upcoming goals are detailed in slide 18, and include completing enrollment in Study 202 by the end of 2015; advancing enrollment in the dose-finding portion of our Phase 1b/2 PRIMAL study in non-small cell lung cancer. Continue to work with our partner Ventana to develop a companion diagnostic, initiating our Phase 1b immuno oncology study evaluating PEGPH20 with KEYTRUDA in both post-platinum non-small cell lung cancer and relapsed and refractory gastric cancer patients. Working with our partner, Eisai to initiate our clinical trial evaluating PEGPH20 with Halaven in metastatic breast cancer. And finally supporting our current ENHANZE partners in their actions to advance products into the clinic, while continuing to identify potential new partners.

I would like to close by thanking the Halozyme team for their continued hard work and progress in advancing the Halozyme programs; supporting our partners; and through this, driving value for our shareholders.

We're now ready to take your calls.

Operator, would you please open the call for questions?

(Operator Instructions)

Andrew Peters, UBS Investment Research.

Thanks for taking my question. Wanted to understand a bit more on the update in non-small cell lung cancer. Was the enrollment going a bit slower than you thought, was that recent? I guess as of June, you had reiterated the 3Q guidance.

And then, just to understand comments on the Phase 3 design, both with FDA and EMA. Is it your view, or is it your understanding that when you talk about trends in overall survival, if you show a similar data set to the Stage 1 part of 202, would that be consistent with a favorable trend? I just want to understand the magnitude of benefit, when you're talking about that trend.

Thanks, Andrew. Let me answer the question on PRIMAL first. It really has just been in the last couple of months that we have not been happy with the progress we've been making on our PRIMAL enrollment. As I mentioned on the call, we have identified that it was an element of trial design, where we would have a patient in screening and not allow other patients to be screened, and we find out we have lost a number of patients, not really a surprise, given some of these patients can be quite ill and progress while they are in the screening period.

We have made an amendment to the protocol to allow for parallel screening, that we believe will help enrollment. And we've added additional centers. So I think our goal is to provide an update on our next call as to the impact these changes we've made. I will say we continue to find investigator enthusiasm very positive for this study, looking at PEGPH20 with docetaxel.

To answer the question, with regard to the trend in overall survival. Neither FDA nor EMA provided specifics as to what an expectation would be in terms of the degree of magnitude of benefit. That is something that Athena and the team are planning around and thinking about, but it will be Halozyme's judgment, with regard to that, what we planned for.

Great, thank you.

Jessica Fye, JPMorgan.

Thanks for taking the question. Can you confirm whether the timing for starting your PD1 combo study in lung, is it all tied to that taxotere combo trial? And then second related to the PD1 study, I believe that is enrolling only high HA patients. Will you use the same cut point as in pancreatic, and is timing for that again, at all, linked to the timing of finalizing the Ventana diagnostic? Thank you.

Thanks, Jessica. Let me answer the question. The two studies in non-small cell lung cancer we articulated as part of our strategy a number of quarters ago, recognizing that both chemotherapy and immuno therapy was going to play an important role in non-small cell lung cancer, and we planned and developed separate teams to be driving these programs. So they are not in any way related. Let me ask Athena to address the question on the cut point.

Thanks, Jessica for the question. There is two points to relate. First, in relation to only allowing patients that are high HA, remembering that this is a Phase 1b trial that will initially have dose escalation portion, and then a dose expansion portion. In the dose escalation portion, we would be allowing patients, irrespective of HA status, and as Helen mentioned today, we are expanding the development in that study to not only lung cancer but also gastric cancer. So when we have expanded the portion into the dose expansion portion, the patients both gastric and non-small cell lung cancer will be HA only, and that will be based on the test that we are developing with Ventana.

Okay, got it. So just given the probably natural timing there, finalizing that Ventana diagnostic, it should not hold up the starting of the PD1 combo studies?

That is correct. Especially as when we start the study in the second half, it will be all comers for the initial dose finding portion of it.

Got it. Maybe sticking with the diagnostic. I know you said you were refining and validating the scanning and scoring methodology. Can you tell us when that is going to be complete? It would be helpful to give us a little comfort in terms of when you can start the Phase 3 study.

So everything is on track for what we stated, which is the start of the Phase 3 study, late in the first quarter of 2016. To give you a little bit more comfort, I can say we've had a series of very productive meetings with Ventana. As recently as two weeks ago, we had the Ventana team in, and we're tracking perfectly to our timelines, and making just the progress that we hoped we would make. At this time, things, the companion diagnostic, is not expected to be a rate limiter for the start of the Phase 3 program.

Got it, thank you. Maybe just one more, if it's okay. That SWOG study you referenced in combination with FOLFIRINOX, is there any timing you can give on when we can see some additional data from that?

As you always know, with a cooperative group, those are funded and run independently, and not in our control. This is an event-driven study, with overall survival as the primary endpoint, and I think we're going to have to let the SWOG group get a little bit further into the Phase 2 portion of that, before they or we would be in a position to give any idea or line of sight as when data might be available.

Got it, thank you.

Charles Duncan, Piper Jaffray.

This is Roy in for Charles, thanks for taking my question. I had a quick one on PRIMAL, which has been mostly answered. I guess just a general question. Is the parallel screening, or I guess, a staggered screening standard set up for these kind of trials? What's more typical?

Often the studies are done the way we did the initial part, Roy, with the patients being in series O screening. But given the population, as I mentioned, in our findings, we've moved forward with the parallel screening, and we think that is going to be that, and the additional centers, are going to get our enrollment accelerated, and we look forward to giving you an update in November.

Okay, very good, thanks.

(Operator Instructions)

Arlinda Lee, MLV & Co.

Thanks for taking my questions. I just wanted some clarification on the cut points. Are you using the same cut point across indications, and maybe in what Ventana -- you are doing in collaboration with Ventana right now, are you going through cancer by cancer to look at the different cut points, or are you just working on pancreatic right now, and what would the process be for going, looking at the cut points for lung and gastric? Thanks.

Our primary focus at the moment is definitely pancreas. That's obviously where we want to assure everything is very nicely in place, and keeps -- as it is at the moment, not being a rate limiter for Phase 3. But we have expanded our work with Ventana to now start looking also at breast cancer and lung cancer, and we are working separately on that.

I think it's a little early for us to say if the cut point will be the same between these three tumors. What we are doing with Ventana is evaluating samples to look and see. You'll have to stay tuned for that update, Arlinda, but I can say we're very pleased working with Ventana. Obviously, we picked them because they're a leader in the field, and we're finding this to be an extremely productive and collaborative relationship, as we expand beyond pancreas cancer into leukemia, breast, and lung as well.

Great, and then can you remind us what portion of gastric cancer patients have high HA? Thanks.

Arlinda, off the top of my head, I am not recollecting exactly. What we'll do is we'll look it up and if we have another question, and I have a chance, I'll mention it in a second.

Okay, great.

Kennen Mackay, Citigroup.

Thanks for taking my question. Two questions. First on the update in non-small cell lung cancer, so when you've an update in November, what will that entail? Will that entail a number of patients that have been through your doors, or an update on timeline? And then secondarily in the US, I was wondering if you would be enrolling all HER2-negative patients irrespective of hormone receptor status and also what percent of patients in that indication are potentially high HA? Thanks so much.

I'll address the question on the enrollment, the update we'll give in November, and then I will ask Athena to comment a little on the patients who are going to be coming into the study with Halaven. In November, what I'm hoping to update on Kennen is to talk about the enrollment. Obviously, we're wanting to be able to update with regard to have the additional centers and the changed protocol made a difference. So at a minimum, you can expect to hear the enrollment update. It would probably be premature to give an update on the overall timeline at that stage, but I will give an update on enrollment. Athena?

Yes, just to expand on what Helen said, for the collaboration with Eisai, we will be looking at HER2-negative irrespective of ER/PR positivity, I think was your question. What we've seen in literature, and this gets back to Arlinda's question as well, is approximately 50% HA in both breast and gastric cancer.

Terrific. Thanks so much for taking my questions.

Thank you. Operator, are there any more questions?

(Operator Instructions)

Eun Yang, Jefferies & Company.

If I missed it, I apologize. I just want to clarify. So Phase 2/3 study in pancreatic cancer that you plan to start at the end of the first quarter of next year, the primary endpoint will be PFS?

It will have two primary endpoints, the first one will be PFS, and the second one will be overall survival.

Okay. The second question is, in the PRIMAL study, I think in the past, you got to mention that about 40% of non-small cell lung cancer patients have a high HA expression. Is that what you are finding as you are enrolling patients?

So we are enrolling all comers at this point of time in the PRIMAL study, and we are at this stage looking, planning to look at the samples retrospectively. So we don't have any data from the PRIMAL study that gives us an estimate for HA percentage yet.

Okay. Another question is the study 202, so full data, normally, you expect it to be completed by the end of this year, and full data is expected sometime next year. Would you see the full data before you start your Phase 2/3 study?

At this point in time, we are focused on the enrollment and starting our Phase 3. Evaluating the data, if there was a reason, is always an option, but at this point in time, we are focused on our start for the Phase 3.

And the last question is on HTI-501. I think the last update you gave us last year was that you were looking for strategic partnership. Any update on that?

We have no update on that. We have continued to identify if another party would be interested in our HTI-501 asset, which we were developing in cellulite. Recall, this is a pre-IND asset for the US, where there was additional chemistry and toxicology and manufacturing work needed, and to date we have not identified a partner with the interest and the right capabilities to advance that. But that is something we are continuing to explore.

Thank you.

(Operator Instructions)

Speakers, I'm showing no further questions at this time, I'll turn it back to you.

Thank you, everybody. I think, as you heard, our two-pillar strategy is again differentiating Halozyme, and allowing us to demonstrate progress across two key value drivers for the Company. Strong progress, and we look forward to providing an update on the next quarterly call. Thank you. Bye-bye, now.

Thank you, ladies and gentlemen. This concludes today's conference. You may now disconnect your lines. Have a great afternoon.