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Edited Transcript of HALO.OQ earnings conference call or presentation 2-Nov-20 9:30pm GMT

·43 min read

Q3 2020 Halozyme Therapeutics Inc Earnings Call SAN DIEGO Nov 3, 2020 (Thomson StreetEvents) -- Edited Transcript of Halozyme Therapeutics Inc earnings conference call or presentation Monday, November 2, 2020 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Albert S. Kildani Halozyme Therapeutics, Inc. - VP of IR & Corporate Communications * Elaine D. Sun Halozyme Therapeutics, Inc. - Senior VP & CFO * Helen I. Torley Halozyme Therapeutics, Inc. - President, CEO & Director ================================================================================ Conference Call Participants ================================================================================ * Anna Gennadiy Vorobyeva-Schiano Goldman Sachs Group, Inc., Research Division - Research Analyst * Charles Cliff Duncan Cantor Fitzgerald & Co., Research Division - Senior Analyst * Guyn Kim BMO Capital Markets Equity Research - Analyst * James William Birchenough Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst * Jason Nicholas Butler JMP Securities LLC, Research Division - MD, Director of Healthcare Research & Equity Research Analyst * Joel Lawrence Beatty Citigroup Inc., Research Division - VP & Analyst * Joseph Michael Catanzaro Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for standing by, and welcome to the Halozyme Third Quarter 2020 Financial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to turn the conference over to Al Kildani, Vice President of Investor Relations and Corporate Communications for Halozyme Therapeutics. Mr. Kildani, please begin. -------------------------------------------------------------------------------- Albert S. Kildani, Halozyme Therapeutics, Inc. - VP of IR & Corporate Communications [2] -------------------------------------------------------------------------------- Good afternoon, everyone, and welcome to our third quarter 2020 financial results conference call. In addition to our press release issued today after the close, you can find a supplementary slide presentation that will be referenced on today's call in Investor Relations section of our website. Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Elaine Sun, our Chief Financial Officer, who will review our financial results for the third quarter 2020. During the call, we will be making forward-looking statements. I refer you to our SEC filings for a full listing of the risks and uncertainties. I'll now turn the call over to Helen. -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Thank you, Al. I'm pleased to report strong financial results for the third quarter of 2020, evidenced by revenue of $65.3 million, which is 18% growth over Q2 and earnings per share of $0.25, which is 32% growth over Q2. As we'll describe in detail, the strong third quarter results were driven by a combination of growth in royalties, which grew 51% sequentially, primarily as a result of the DARZALEX subcutaneous uptake. And also as a result of substantial progress by our partners with their drug development pipelines. Based on these results and our outlook for the fourth quarter, we are pleased to announce we are raising our full year revenue guidance to $250 million to $260 million from $230 million to $245 million, which is a 28% to 33% increase over prior year revenue. We're also increasing our earnings per share guidance to $0.80 to $0.85 from our prior guidance of $0.60 to $0.75. As these results demonstrate, the vision we described for the future of our company approximately 1 year ago when we transitioned our business to focus on ENHANZE is now truly bearing fruit in the form of growing revenues, earnings and cash flow. This has also enabled us to deliver on our commitment to return capital to shareholders in a meaningful way. In the third quarter, we repurchased $58.9 million worth of shares or approximately 2.1 million shares, resulting in $312.4 million in capital returned to investors via our share repurchases in less than 1 year as part of the authorized 3-year $550 million share buyback program. All of this progress was made possible by our partners and the Halozyme team adapting very effectively to the many changes imposed by COVID-19 on the business and our life. As a result, we are in a strong position as we close out 2020, and we look forward into 2021. Turning now to Slide 3, I'll discuss our growth in royalties. We are delighted by the strong growth in royalties, and I wanted to provide some context for this achievement. As illustrated on the left, in the third quarter, revenue from royalties grew 44% year-over-year and 51% sequentially. We're delighted to be embarking upon a period of projected strong growth in royalties, propelled by the launch of DARZALEX FASPRO in the U.S. and DARZALEX SC outside the U.S. I'm pleased to report that we now project full year royalty revenue growth of 14% to 22% compared to the prior year, resulted in projected 2020 royalty revenues of $80 million to $85 million. Let me now provide some additional color on the subcutaneous DARZALEX launch. Janssen received regulatory approvals for U.S. and EU and -- sorry, for U.S. and the EU in May and June, respectively. Meaning that the third quarter was the first full quarter of sales. During the third quarter, Janssen's parent J&J reported worldwide sales of DARZALEX, including the IV and SC forms of $1.1 billion, up 44% year-over-year on an as-reported basis. While J&J does not provide a breakdown of sales between the IV form of the drug and the subcu form utilizing ENHANZE, we can share based on our evaluation of syndicated sales data, that the launch is off to a strong start in the U.S. and in countries outside the United States. We project continued growth in royalties of DARZALEX FASPRO and DARZALEX SC adoption and conversion increase in the already launched countries and new launches occur in additional countries following reimbursement confirmation. Turning now to the additional positive data readout and potential label expansion for DARZALEX FASPRO and DARZALEX SC. On October '21, Janssen development partner, Genmab, announced data from the second part of the Phase III CASSIOPEIA study, evaluating daratumumab as maintenance treatment in patients with newly diagnosed multiple myeloma, eligible for autologous stem cell transplant, who had achieved a response during part 1 of this trial. The study met the primary endpoint of progression-free survival at a preplanned interim analysis. Based on the data, Janssen plans to discuss the potential for a regulatory submission with health authorities and the data are expected to be presented at an upcoming medical meeting. On September 10, we announced that Janssen submitted a supplemental biologics license application to the FDA seeking approval for DARZALEX FASPRO utilizing Halozyme's ENHANZE technology for the treatment of patients with light chain amyloidosis, which is a rare and potentially fatal disease for which there are currently no approved therapies. The supplemental BLA was based on positive Phase III data from the ANDROMEDA study. There are an estimated 30,000 to 45,000 patients in the United States and European Union, who have light chain amyloidosis. Notably, only the subcutaneous version of DARZALEX with ENHANZE was selected to be studied for this indication. And upon positive regulatory opinion, DARZALEX SC would be specifically approved for this indication. We look forward to a future decision on acceptance of this filing by the FDA. As I just highlighted, not only is the long-term subcutaneous DARZALEX off to a strong start, Janssen also has a robust development program with the potential to further expand the patient population that can be treated with DARZALEX SC. And we look forward to providing further updates in this area. Let me move now to Slide 4 for a discussion of the additional products that are commercialized in the U.S. and rest of world utilizing our ENHANZE technology. Roche continues with its global commercialization of MabThera or Rituxan Hycela and subcutaneous Herceptin and Herceptin Hylecta. Royalties from these more mature products are projected to decline modestly this year, primarily as a result of the ongoing impact from biosimilars. We do expect to see future growth in the Roche portfolio of products driven by Phesgo, which was recently launched in the United States. Phesgo is a fixed-dose combination of 2 Roche drugs that are the backbone of treatment for early and metastatic HER2-positive breast cancer, specifically Perjeta and Herceptin. Phesgo is in the early launch stage and as a result, did not contribute meaningfully in the quarter with Roche reporting third quarter sales of CHF 7 million. This is not unexpected as Roche is working through all of the steps to support full access in the United States, including gaining formulary approvals and inclusion into electronic medical records. Based on submission timing for Phesgo in Europe and assuming standard review time, we see the potential for approval of Phesgo in Europe in the first quarter of 2021. In Europe, gaining reimbursement approval will be a key step for launch, and this can take up to 6 to 9 months in several of the key European markets. Winding out our discussion of the current products on September 15, Takeda Pharmaceutical announced that the European Medicines Agency approved a label update for HYQVIA. Broadening its use and making it the first and only facilitated subcutaneous immunoglobulin replacement therapy in adults, adolescents and children with an expanded range of secondary immunodeficiencies. Takeda will now be able to target this segment of the market, which according to Takeda, is estimated to represent about 15% of IgG use in the U.S. and EU. I'll move now to Slide 5 and a discussion of our partners' development pipeline. I'm pleased to update the progress our partners are making in the clinic with drugs utilizing our ENHANZE technology. At the beginning of the year, we projected 9 study starts in 2020. I'm pleased to say that based on latest partner communications, this remains our expectation. To date, 3 studies have started and we project an additional 6 studies will be ready to start in the fourth quarter. Let me recap the 3 trials that have already started. These are the argenx Phase II trial of efgartigimod in CIDP, which began in the second quarter. BMS' relatlimab plus nivolumab Phase I study, which also began in Q2 and what we call the CAPRISA study, which began in Q3. Let me just say a word about this CAPRISA study. This is a study that's being conducted by the Center for AIDS Program of South Africa or CAPRISA, in conjunction with the Vaccine Research Center, a division of one of the institutes within the NIH. The study is evaluating the safety, tolerability and pharmacokinetics of a subcu human monoclonal antibody administered with ENHANZE in HIV negative and HIV positive women in South Africa. Turning now to the 6 remaining studies. We project that 3 Phase III or registration trials will start in the fourth quarter. These are the recently announced argenx efgartigimod study in pemphigus vulgaris and foliaceus, the Roche Phase III study with Tecentriq. And we recognized $32 million in milestone payments in the third quarter, including $15 million for the argenx and $17 million for Tecentriq related to progress to date towards these 2 study starts. A third Phase III study is also projected to be ready to start in the fourth quarter. This is currently undisclosed at the request of the partner. And we continue to expect our partners to be ready to start 3 additional Phase I studies in the fourth quarter. Let me now provide a brief partner by partner discussion of these programs. I'll begin with argenx, which has nominated 2 targets to date, the human neonatal SC receptor, which efgartigimod is designed to block and complement component C2 with ARGX-117. Argenx is progressing 3 separate studies at this time for SC efgartigimod with ENHANZE. Argenx recently provided an update that enrollment in its Phase II ADHERE study, which is evaluating efgartigimod with ENHANZE in CIDP is progressing well. Argenx expects a go no-go decision to expand the trial up to 130 patients will occur after the first 30 patients are treated in Part A of the study and expects the decision will occur to expand in the first half of 2021. With regard to SC efgartigimod with ENHANZE in myasthenia gravis, argenx plans to meet with the FDA during the current quarter to discuss a bridging strategy for SC based on the positive results of its ADAPT trial, which evaluated the IV form of efgartigimod in myasthenia gravis. Argenx has stated it will communicate its plans as soon as it has written minutes from the FDA meeting. We look forward to learning of the next steps for this exciting program, which could result in initiation of testing of SC efgartigimod with ENHANZE in myasthenia gravis in a registration study in 2021. Argenx also recently announced that it plans to evaluate SC efgartigimod with ENHANZE in its Phase III ADDRESS trial in pemphigus vulgaris and foliaceus, which they indicated is on track to start this quarter. Pemphigus is a serious skin barrier disease, which is associated with painful blistering. The Phase III ADDRESS trial will be a randomized, double-blind, placebo-controlled study, where the objective is to assess the efficacy, safety and tolerability in up to 150 newly diagnosed or relapsing patients with moderate to severe pemphigus. The primary endpoint will assess the proportion of patients who achieved complete remission on a minimal steroid dose at 30 weeks. As noted earlier, the advancement of this program to this stage triggered recognition of $15 million of revenue during the third quarter. Now turning to the second argenx nominated target, ARGX-117. Argenx announced, they recently initiated a Phase I study, evaluating ARGX-117 in healthy volunteers, with data expected in mid-2021. ARGX-117 is targeting C2 for the treatment of multifocal motor neuropathy, or MMN, a severe autoimmune disease. We expect to receive a milestone payment in the near-term related to the subcu advanced component of this study. As you have heard, argenx is making rapid progress in the clinic with subcutaneous forms of its drugs utilizing ENHANZE and are evaluating a broad range of potential indications with the goal of accommodating patient preference and to adjust to the new norm, where patients may not always have easy access to all sites of care. And building on this progress and vision, we were delighted to expand our collaboration on licensing agreement with argenx last month. As a result, argenx will now have the ability to exclusively access our ENHANZE technology for 3 additional targets upon nomination for a total of up to 6 targets under the existing and newly expanded collaboration. Let me move now to Roche. In September, we announced that Roche presented a poster with data from Part 1 of its Phase Ib study evaluating atezolizumab or Tecentriq for subcutaneous administration using ENHANZE in patients with locally advanced or metastatic non-small cell lung cancer. This data was presented at the European Society for Medical Oncology Virtual Congress. The poster concluded that atezolizumab utilizing ENHANZE provided similar exposure as atezolizumab IV and that the results supported further development of subcutaneous atezolizumab in a confirmatory Phase III study. In October, Roche provided details of the planned Phase III trial design on clinicaltrials.gov. Significant progress towards the start of the Tecentriq Phase III trial triggered recognition of $17 million in revenue during the third quarter. And in addition, Roche continues with its Phase I study, which is evaluating subcu administration of atezolizumab or Ocrevus with ENHANZE. I'll move now to Bristol-Myers Squibb. BMS is progressing 3 separate targets utilizing ENHANZE across 4 distinct programs. Specifically, BMS continues with 4 Phase I programs. These are with nivolumab, BMS' anti-CD73 and relatlimab in combination with nivolumab. Additionally, BMS initiated in the second quarter of 2020, a Phase I/II study of ipilimumab in combination with nivolumab, utilizing our ENHANZE technology. We are excited that our current partners continue to provide new growth opportunities for ENHANZE. And I can say we already have line of sight to several additional -- potential additional new target selections by current partners and plans to progress from Phase I to Phase III development in 2021. We look forward to providing more updates as additional programs are nominated and enter or advance in the clinic. And let me now just comment on new enhanced deals. It remains the case that we have a broad slate of ongoing discussions with both biotech and pharma companies. I continue to be pleased with the pace of these discussions and remain confident that we will sign additional deals. As ever, the timing is hard to predict. Turning now to Slide 6. I will discuss our outlook for anticipated growth in milestone revenues. The growth in and the progress of our enhanced portfolio is projected to drive strong growth in milestone revenues in the coming years. Based on the latest information from partners, we continue to project cumulative milestone revenue in the 2020 to 2022 3-year period of between $350 million to $450 million. This near-term milestone revenue precedes the royalty revenues and is an important and strong indicator for future royalty revenues, which we project to have the potential to be approximately $1 billion in 2027, based on our non-risk-adjusted revenue projections for programs that are currently in or in planning for development. Turning now to Slide 7. We'll discuss our approach to value creation and capital return. Our first priority is always to drive the growth in our ENHANZE business by maximizing the value of our current collaborations and working to sign and advance new collaboration partners. With strong projected free cash flow, our next goal is returning capital to investors via share repurchases through our 3 year $550 million share repurchase program. We've demonstrated our commitment to this goal by already repurchasing more than $312 million worth of shares or approximately 57% of the amount authorized in less than 1 year. We will continue pursuing share repurchases under this program for the remaining period of the authorization, pending market conditions and other factors. In addition, we continue to evaluate the potential for new technology platform expansion through acquisition with the goal of accelerating our long-term revenue growth. In evaluating this, we are seeking an approach that has high-growth potential and high margins like our ENHANZE business. As we look longer term, we are confident that Halozyme's strong financial position will enable us to continue delivering value to shareholders via capital return. And with that update, I'll now turn the call over to Elaine for a discussion of our third quarter financial results. -------------------------------------------------------------------------------- Elaine D. Sun, Halozyme Therapeutics, Inc. - Senior VP & CFO [4] -------------------------------------------------------------------------------- Thank you, Helen. Let me start by turning to Slide 8 for a review of our third quarter revenues. So as Helen indicated, we saw strong growth in the quarter as our partners continued to execute on their commercial and development plans. Total revenue for the third quarter was $65.3 million, an increase of 41% compared to $46.2 million in the prior year period. I'll now discuss the 3 components of our revenue. Revenue from royalties for the quarter was $23.9 million, a year-over-year increase of 44%. And as Helen discussed, our royalties returned to growth sooner than expected, primarily due to the successful launch of subcutaneous DARZALEX utilizing enhanced technology by partner, Janssen. Product sales were $9 million in the quarter compared with $29.2 million in the year ago period, during which there was a large sale of bulk rHuPH20 to Janssen in preparation for their launch of subcu DARZALEX. Collaboration revenue in the quarter totaled $32.3 million, up from $0.4 million in the year ago period as a result of recognizing revenue for expected milestone payments from our partners, argenx and Roche, related to their progress to date towards Phase III study starts. Let me move to Slide 9, and you'll find a more detailed breakdown of our third quarter P&L. So beginning with total operating expenses, which were $25 million in the third quarter, down 65% from $70.8 million in the prior year period. The overall decrease in total operating expenses resulted from our shift in strategic focus to the company's ENHANZE drug delivery technology in November of 2019 and the related restructuring, which has now been completed. Cost of product sales were $5.6 million compared with $22.3 million in the year ago period, with the decrease attributable to the same large sale of bulk rHuPH20 to Janssen that I mentioned a moment ago, related to their preparation for the launch of subcu DARZALEX. Research and development expenses of $7.7 million decreased 75% from $30.5 million in the prior year period as a result of halting our PEGPH20 oncology drug development activities in November of last year. And SG&A expenses were $11.7 million, down 35% from $18 million in the prior year, primarily due to the reduction in force and discontinuation of PEGPH20 related launch readiness expenses following the company's restructuring. And I'm pleased to report that net income for the quarter was $36.2 million or $0.25 per share compared to a net loss of $25 million or $0.17 per share in the third quarter of 2019. And this marks our second consecutive quarter of what we expect will be sustainable profitability and cash flow generation going forward for Halozyme. With respect to our cash position, cash, cash equivalents and marketable securities were $346.7 million at September 30, 2020 compared to $421.3 million at December 31, 2019. This decrease reflects the impact from our operating loss in the first quarter and share repurchase activities through the first 3 quarters of 2020. Now let me turn to Slide 10 for a discussion of our 2020 financial guidance. Based on the latest information from our partners and our planned expenditures for the year, I'm pleased to share our increased guidance for 2020. We now expect total revenues of $250 million to $260 million, up from our prior guidance of $230 million to $245 million, which would represent year-over-year growth of 28% to 33%. Of that total, we expect revenue from royalties to comprise $80 million to $85 million. We have previously anticipated flat royalties year-over-year in 2020. However, we are now in a position to increase our expectations based on the early sales trends for subcu DARZALEX utilizing ENHANZE. Looking at the other components of our projected 2020 revenue guidance range, we further expect revenue under collaboration of $115 million to $120 million driven by new clinical trial starts and commercial milestones. In addition, we expect a substantial increase in API revenue in the fourth quarter resulting in projected full year product sales between $52 million and $57 million. Excluding nonrecurring expenses related to the wind-down of our former oncology operations in the first half of 2020, we continue to expect annualized operating expenses, excluding COGS, to be at the top end of our guidance of $65 million to $75 million in the fourth quarter of 2020 or between $18 million and $19 million for the quarter. Moving to earnings per share. We are increasing our guidance range to $0.80 to $0.85, up from our prior guidance range of $0.60 to $0.75. During the quarter, we continued our share repurchase activities under our 3-year $550 million share repurchase program that was authorized by our Board a year ago. And in the third quarter, we repurchased $59 million worth of our common shares or 2.1 million shares at a weighted average price of $27.57. Our commitment to capital return driven by a diversified portfolio of partnered products and programs, sustainable profitability and a strong growth and cash flow outlook has resulted in share repurchases through end of the third quarter of $312.4 million at a weighted average price of $18.92. And all of this has been accomplished less than 1 year into our $550 million 3-year buyback program. We continue to expect we'll repurchase up to $150 million in our shares this year, which would mean up to an additional $37.6 million that could be repurchased in the fourth quarter, pending market conditions and other factors. So with that, I'll now turn the call back to Helen. -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [5] -------------------------------------------------------------------------------- Thank you, Elaine. We believe we are still only at the beginning stages of delivering on both the clinical and financial promise of our ENHANZE enhanced drug delivery technology. Our technology delivers value for our partners, our patients and our Halozyme shareholders. Halozyme is in the strongest financial position ever as a company, and we look forward to strong growth in our revenues, profitability and cash flow in the coming quarters and years, which will allow us to deliver on our commitment to return capital to shareholders, maintain long-term sustainable growth and maximize shareholder value. I'll close on Slide 11. Entering 2020, we established this ambitious set of goals to measure our performance as we completed the company restructuring. I could not be more pleased with the tremendous progress to date. And as you've just heard, we project we will finish the fourth quarter as strongly as this one. I'd like to end as ever by thanking the amazing Halozyme team for your tremendous efforts and these strong results. With that, we'd now be delighted to take your questions. Operator, please would you open up the call for the questions. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Your first question comes from Charles Duncan from Cantor Fitzgerald. -------------------------------------------------------------------------------- Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [2] -------------------------------------------------------------------------------- Helen and Elaine, congratulations on some really awesome results in this quarter. I had 2. One is kind of a financial one and one is a pipeline one, Helen, with regard to the launch of FASPRO, I'm sure you won't be able to say too much on this, but maybe provide a little bit of color. When you think about the conversion rate thus far, how much of it was driven perhaps by, say, the COVID environment? And how much of it is driven by substantial difference in the clinical profile of the compound or of the drug? And where would you expect the conversion rate to end up over time? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [3] -------------------------------------------------------------------------------- Yes. Thanks, Chaz. I don't have any data to support the impact of COVID on the uptake of DARZALEX FASPRO in the U.S., and we also know that there has been successful launch outside the U.S. as well. What I can see is the performance has certainly exceeded our expectations. And whether COVID has played a role in that, it would seem possible it had, but I don't have any data to support that, but we are certainly absolutely delighted with the strong initial uptake. We don't provide and we haven't provided any specific guidance as to what we think the conversion will be. But I would just say that when you think about a patient today facing what is often 4, 6 hours IV infusion, who could have the option of receiving the treatment in just the 3 to 5 minutes in a subcu injection, we certainly think this is a very strong value proposition. And we think patients are definitely going to welcome at both the new to start patients, but also the patients currently receiving the IV. -------------------------------------------------------------------------------- Charles Cliff Duncan, Cantor Fitzgerald & Co., Research Division - Senior Analyst [4] -------------------------------------------------------------------------------- Makes sense. Appreciate that. And then a quick question on the pipeline. If I look at -- but for, I guess, HYQVIA, all of the drugs are primarily used in the oncology setting or hematology setting, yet you're moving into -- with this diversification with argenx and efgartigimod into neurology. And I guess I'm wondering if you think neurological disorders or neurology is really a growth opportunity, number one. And could you see more movement in that diversification direction? And number two, what do you think the agency is going to think about in terms of reviewing the product profile say, the neurology division versus oncology, do you think there'll be a different risk benefit? Or do you think that's pretty well-established across the agency? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [5] -------------------------------------------------------------------------------- Yes. I think, as it turns out many of our initial approvals, as you point out, Chaz, were in oncology. That just happens to be that many of the -- most successful brands in the world are in oncology, and we're delighted to be seeing as not just moving into neurology, as you mentioned, but also into autoimmune diseases. And so we see continued strong potential to expand outside of oncology into multiple additional indications where patients are receiving their therapies via long IV infusions. In neurology, we also have Ocrevus, if you recall that I mentioned that Roche is developing. So lots of potential, any injectable drug with a long infusion, we certainly welcome talking to companies to see whether a subcu would bring benefits like competitive differentiation. We now have 5 approvals given by the FDA and 4 so far outside the U.S. And I do feel that with the comments we've been getting back with each subsequent review, there are less and less, and I do believe that the safety profile of rHuPH20 is now very well characterized in more than 400,000 patients treated commercially with the drug. And so I would not expect a big difference between a neurology division from an oncology divisions because of that long track record of safety data we'll be able to bring forward. -------------------------------------------------------------------------------- Operator [6] -------------------------------------------------------------------------------- Your next question comes from Jim Birchenough from Wells Fargo. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [7] -------------------------------------------------------------------------------- Let me add my congratulations on the quarter. A couple of questions. I guess first, Helen, just on DARZALEX FASPRO and subcu. Can you remind us, is there anything in terms of the agreement where the royalties might true-up with increasing sales? Or is it fixed, independent of the level of sales? And then I guess second question is just as you look at the ramp of DARZALEX FASPRO and early launch of Phesgo, are there payer dynamics or market dynamics that are different between those 2 products, if you can comment at all? And then I have a follow-up. -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [8] -------------------------------------------------------------------------------- Yes. Yes, we don't provide specific details on a contract by contract basis. We certainly in some of our contracts do have tiering, but I can't speak specifically to the Janssen one. With regard to the launch uptake of Phesgo versus FASPRO, it certainly does appear that FASPRO is out of the gate very fast. Now recall, it has been approved in the U.S. and Europe and was approved in May and June, respectively, whereas Phesgo was only approved in the U.S. so far and at the very end of June, so really launching in July. So I do think timing is a factor. And we would expect and we had signals, but our expectation was that the first few quarters would be very much focused on laying down the ground work for physicians to be able to freely write these drugs, getting EMRs, formularies, et cetera. So we would expect the first quarter to be slow. And obviously, exception to that is how FASPRO is performing as well as DARZALEX SC. But for Phesgo, as we get all of that in place, we expect 2021 to be a year of robust uptake of Phesgo as well. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [9] -------------------------------------------------------------------------------- And Helen, just a second line of inquiry, just around IP. And we get the question often about how to think about the 2027 and 2024 patent cliffs for PH20. So just giving you an opportunity, how do you think about it, both in terms of new deals post those fine points, products and development and products on the market? What do you see in terms of the risk to each of those layers of the business? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [10] -------------------------------------------------------------------------------- Yes. I think what's unique about ENHANZE and the fact that, yes, our U.S. patent does expire in 2027. Recall the construct of our contract is that we will continue to receive royalties for a minimum of 10 years after the first commercial sale. So that's a very important factor as you're thinking about the products that are entering in the clinic today that could get approved in 2004, '05, '06. In 2027, they will be in a very robust of their growth cycle. Now at the time of the patent expiry, if there is no co-formulation patent in place, there is a step down to approximately 50%. But recall, these could be products that are in a very attractive growth period. So you've got to layer that on and think about that dynamic as well. And our current projections only include those products that we have line of sight for today. And so I've already mentioned that in 2021, we expect additional partners will bring targets into the clinic. Those are additional launches that are going to continue that overall revenue growth so that even if there is a step down, there is still the potential that we can continue to grow beyond that. And then finally, we have this wonderful option of applying for co-formulation patents, which are not all guaranteed to be granted, but if there is novel, they can be granted. And the general effect of those is that they prolong the time that we can get the duration of the royalties and can push out the times of the step down. And so I will say that post 2027, Jim, the key takeaway is we can see a very clear path to continued royalty growth after 2027. We know exactly what we need to do that. We need to launch more products and we need to get more co-formulation patents. And so that is unique about ENHANZE. And we're excited about that and what it can mean for the ongoing substantial royalty revenues from our pipeline. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [11] -------------------------------------------------------------------------------- Helen, just quickly on that last point, can you say if there's any -- been any new co-formulation patents filed this year or expected to be filed this year without naming any specific products? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [12] -------------------------------------------------------------------------------- Yes, we do have one partner who is intending to file a co-formulation patent this year. -------------------------------------------------------------------------------- Operator [13] -------------------------------------------------------------------------------- Your next question comes from Do Kim from BMO Capital Markets. -------------------------------------------------------------------------------- Guyn Kim, BMO Capital Markets Equity Research - Analyst [14] -------------------------------------------------------------------------------- Congrats on the quarter from myself also. First, on the performance of DARZALEX SC. Do you have a sense of what the distribution of sales was between the U.S. and EU? And also, do you think the timing is a potential factor between the -- for the difference between FASPRO and Phesgo? Is it possible that we could see a similar kind of strong quarter for Phesgo in 4Q? And does your raised guidance include that possibility? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [15] -------------------------------------------------------------------------------- Yes. Let me start for the second question. We expect that the European approval, the earliest that will occur is the first quarter of 2021. And so as we think about the total potential for Phesgo, the approval in Europe in 2021, the duration of time it takes to get things in place in the U.S. really does signal towards us thinking the robust growth of Phesgo is in 2021 with the fourth quarter really being a setup year. We don't have and J&J did not provide though any specific breakdown between the U.S. and Europe. Based on our triangulation of syndicated sales data and reported sales, we estimate that the majority of sales are occurring in the U.S., but there has been good uptake in European markets as well. So we look forward to perhaps Janssen providing some more color on that at a later date. -------------------------------------------------------------------------------- Guyn Kim, BMO Capital Markets Equity Research - Analyst [16] -------------------------------------------------------------------------------- Great. Understood. And a question on the pipeline. For Roche, when they start the Phase III for atezolizumab in lung cancer, do you know what their potential registration path for expanding that therapy beyond its current approval in lung cancer and all the other cancers that it's already approved for? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [17] -------------------------------------------------------------------------------- I will say that in conversations that each individual partner has with the FDA, they talk with them about what the potential scope of indications that might be from their proposed clinical development programs. That obviously is proprietary information that is the property all of -- each of those companies. So while we are aware of it, we unfortunately aren't able to talk. But what we do know is that the FDA at the Rituxan Hycela ODAC did see that a separate study may not be needed for each and every indication as we go forward. And we know that all of our partners are aware of that, engage in discussions with the FDA to try and identify what is the right-sized clinical program for all of the indications that they want. -------------------------------------------------------------------------------- Operator [18] -------------------------------------------------------------------------------- Your next question comes from Jessica Fye from JPMorgan. -------------------------------------------------------------------------------- Unidentified Analyst, [19] -------------------------------------------------------------------------------- This is [Brendan] on for Jess. So with how lumpy share repo has been, can we get some color on how your team has approached those decisions? And if that's sort of going to be your strategy moving forward? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [20] -------------------------------------------------------------------------------- All right. Let me ask Elaine to address that. -------------------------------------------------------------------------------- Elaine D. Sun, Halozyme Therapeutics, Inc. - Senior VP & CFO [21] -------------------------------------------------------------------------------- Sure. Thanks for the question. So I think we've indicated that we have a total 3-year share buyback program that was approved by the Board in November of 2019. We're about 56%, 50 or so percent of the way there with only 1 year into the program. To date, we've repurchased about just over $312 million of our common shares, about 16.5 million shares at an average price of $18.92. This year, we've purchased of that $112.4 million at an average price of $20.76. Obviously, our stock has traded up, I think, reflecting the strong growth potential of our partners' products and programs and the strong growth trajectory for Halozyme. We continue to have, I think, a lot of confidence in terms of the diversified portfolio that Halozyme represents of the multiple blockbuster products and programs of our partners. And our share buyback program, I think, will continue to reflect that. -------------------------------------------------------------------------------- Unidentified Analyst, [22] -------------------------------------------------------------------------------- Okay. And then just looking at Phesgo, you've mentioned a couple of times. You expect a really robust year heading into 2021 here. Do you have any color or expectations you can give us for time line on getting EU reimbursement contract set up there? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [23] -------------------------------------------------------------------------------- Yes. We know if the EMA do a standard review. Based on when Roche indicated, they have submitted the application. We would expect a positive -- if there's a positive opinion, approval in the first quarter of 2021. -------------------------------------------------------------------------------- Operator [24] -------------------------------------------------------------------------------- Your next question comes from Jason Butler from JMP Securities. -------------------------------------------------------------------------------- Jason Nicholas Butler, JMP Securities LLC, Research Division - MD, Director of Healthcare Research & Equity Research Analyst [25] -------------------------------------------------------------------------------- Let me add my congrats on the quarter. Helen, just wanted to follow-up on a couple of comments you made about FDA. And you said Rituxan Hycela, the FDA add comments that not all indications may need separate trials. Is there anything that your -- in your dialogue with partners and FDA that suggest this perspective is shared broadly across the agency versus being specific to that view of a division or specific to oncology or hematology? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [26] -------------------------------------------------------------------------------- Yes. As I think Chaz pointed out, the majority of our products have been in the oncology division, and I'd say that's where many of the conversations are happening. But there are also conversations happening with some of the other divisions based on the stage of the programs, but there are less of those. But I do think, I mean if we triangulate as to what the FDA might have in their mind and we see that through DARZALEX with them not receiving the pomalidomide with daratumumab indication initially for the subcu because there wasn't any data supporting it and there might have been a safety question. And so what I think is logical for the FDA no matter the division to support is to look at this from the perspective of, is there any theoretical reason why the addition of rHuPH20 would add a new safety question. In the majority of cases, that is not going to be the case. And therefore, we don't think that's going to be an issue. But there will be instances where the FDA does say, please generate data, there isn't any data, and this is a theoretical concern. So I think that is the logic that FDA will apply. And I think it could happen in any of the divisions. And I'll just say again, we have a robust safety database with now over 400,000 patients treated commercially, which I do think really does help with the FDA in understanding that's very well established and clear strong safety profile of rHuPH20. -------------------------------------------------------------------------------- Jason Nicholas Butler, JMP Securities LLC, Research Division - MD, Director of Healthcare Research & Equity Research Analyst [27] -------------------------------------------------------------------------------- Okay. Great. And then in terms of the additional trial Phase III study from the undisclosed program to start in 4Q, is there a milestone payable on the start of that study? And also either of the other 2 undisclosed Phase I studies that could start this quarter? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [28] -------------------------------------------------------------------------------- Yes, there are milestones associated with the Phase III and the Phase Is. -------------------------------------------------------------------------------- Operator [29] -------------------------------------------------------------------------------- Your next question comes from the line of Joe Catanzaro from Piper Sandler. -------------------------------------------------------------------------------- Joseph Michael Catanzaro, Piper Sandler & Co., Research Division - VP & Senior Biotech Analyst [30] -------------------------------------------------------------------------------- Congrats on the nice quarter here. Helen, you may have touched on this a bit in your prepared remarks. But wondering if you could comment a little bit more qualitatively maybe on how the legacy products performed sequentially in the quarter, just to maybe get a better sense of DARZALEX SC's full contribution in the quarter. And then I know you mentioned you didn't have visibility into revenues with regards to U.S. and ex U.S. and DARZALEX FASPRO. But wondering if you can speak to just the general conversion rate you're seeing in different territories? And whether the U.S. is, in fact, seeing the highest early conversion rate? Or are there other ex U.S. territories that are seeing that? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [31] -------------------------------------------------------------------------------- Yes. I'll take the DARZALEX One, and then I'll turn the legacy products over to Elaine. Based on the uptake of DARZALEX, we're aware from triangulating on the syndicated sales data and the overall sales that are published by J&J, that there are sales in the U.S. and ex U.S. for subcu, with the U.S. being the larger 1 of the 2. We do not have any insights into the actual specific conversion rate outside the U.S. There is some directional information, as you're probably aware, in the syndicated data. However, this has not been confirmed or verified by J&J. And so we're not in a position to talk about the uptake. But I think it's very clear to see that with the substantial increase that we saw quarter-on-quarter, which we've said is primarily driven by DARZALEX, there has been very strong uptake, predominantly in the U.S., but also in markets outside the U.S. coming from new and continuing patients. And with that, I'll turn it over to Elaine just to talk about the trends with the legacy products. -------------------------------------------------------------------------------- Elaine D. Sun, Halozyme Therapeutics, Inc. - Senior VP & CFO [32] -------------------------------------------------------------------------------- Sure. So as you know, Joe, we don't break out our individual royalties. But for quarter-on-quarter, the overall royalties were relatively flat for all the subcu products, excluding DARZALEX, so Herceptin, MabThera and HYQVIA. And for 2020, we project a decline in Herceptin subcu and MabThera subcu as a result of ongoing biosimilar competition based on the information that Roche has provided as well. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- Your next question comes from Anna Vorobyeva from Goldman Sachs. -------------------------------------------------------------------------------- Anna Gennadiy Vorobyeva-Schiano, Goldman Sachs Group, Inc., Research Division - Research Analyst [34] -------------------------------------------------------------------------------- This is Anna on for Graig Suvannavejh. Congratulations on the quarter. Just a few questions from us. When can we expect to see some contribution, some meaningful contributions from the SC DARZALEX to hit the top line from EU? And also similar for Phesgo? And just also any comments for any additional updates on any potential BD in the future? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [35] -------------------------------------------------------------------------------- All right. So we do have commented, Anna, that all of the royalties that we're seeing in the third quarter, there are already contributions from outside the U.S. We don't have any details as to exactly where those are coming from as yet. But they already -- there is uptake in markets outside the U.S. For Phesgo, we anticipate European approval if it follows standard time lines would occur in the first quarter of 2021. And so at the moment, as I mentioned earlier, really the focus is on getting everything set up in the United States and continuing to get the formularies and the EMR and all of the other logistics with Phesgo. For additional BD, we are very engaged in a number of discussions with regard to ENHANZE. And I remain very confident we'll sign additional deals for ENHANZE. And then as we're looking at other technologies, yes, we continue to be evaluating a number of technologies looking for a match to what we think is going to be important, an opportunity to increase our revenue growth in a manner that has a profile like ENHANZE with a high margin and high growth. So nothing to update specifically there, but actively at work looking at opportunities. -------------------------------------------------------------------------------- Operator [36] -------------------------------------------------------------------------------- (Operator Instructions) Your next question comes from Joel Beatty from Citi. -------------------------------------------------------------------------------- Joel Lawrence Beatty, Citigroup Inc., Research Division - VP & Analyst [37] -------------------------------------------------------------------------------- Congratulations on the quarter. My question is on FASPRO. Are you able to provide any context on the trajectory of growth in royalties that you're seeing and trajectory of the conversion from IV to subcu? And any reason to think that the next few months could be any different than the trajectory you saw over the last few months? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [38] -------------------------------------------------------------------------------- Yes. Thanks, Joel. As we look at it, we mentioned that this is the first full quarter of sales for FASPRO. And so we are going to be evaluating the continued trend and the additional data points over the next months. When we think about where additional growth will come from in the already launched markets, which is U.S. and some of the markets outside the U.S. Obviously, there's an opportunity, given we're only 1 quarter in, the growth is going to come from our physicians adopting and getting deeper penetration and uptake in the individual clinic. And so that, I think, will continue to drive strong growth. And then as we think about markets that have not yet launched them, we know that as reimbursement has got in place, we're going to see a cascade of additional launches occurring over the next months and quarters. And so, Joe, based on everything we know, there are so many growth drivers with only 1/4 of sales under our belt, I do expect to see a very good trend, but we're trending off 3 data points at the moment. And so we certainly are going to be watching very carefully in the next months to see exactly what that rate of growth is going to be. But there are, as I mentioned, many drivers for strong continued growth. -------------------------------------------------------------------------------- Joel Lawrence Beatty, Citigroup Inc., Research Division - VP & Analyst [39] -------------------------------------------------------------------------------- That makes sense. And then maybe another question, and it's on -- just at a higher level on partnering. When you have new targets that are not selected by any partners to date, how does that discussion go in terms of who gets first preference? Can a new company come in and grab it? Or do existing partners get any type of look at the new target before a new company could grab it? -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [40] -------------------------------------------------------------------------------- I think firstly is a simplification. It's first come first serve. If someone is in bona fide negotiations with us for a target, and they are a new partner, then they will get the target. If it is an existing partner and they nominate the target, they will get the target. So it really is a first come first serve situation. -------------------------------------------------------------------------------- Operator [41] -------------------------------------------------------------------------------- That was our last question. At this time, I will turn the call back over to the presenters. -------------------------------------------------------------------------------- Helen I. Torley, Halozyme Therapeutics, Inc. - President, CEO & Director [42] -------------------------------------------------------------------------------- Thank you very much, and thank you, everyone, for joining this call. As you can hear, we are absolutely delighted with the very strong progress in the third quarter. And what it means and signals for the importance of the enhanced portfolio. Obviously, we're seeing a very robust uptake in the United States on the subcu product. And I think that's a milestone we certainly should be marking and recognizing. I'll say again, the team has navigated through a lot of challenges in 2020, and we are very excited about all of the progress to date, and importantly, what that means for the company for 2021. Thank you so much for your attention. -------------------------------------------------------------------------------- Operator [43] -------------------------------------------------------------------------------- Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.