Halozyme Therapeutics Inc
NASDAQ:HALO
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Halozyme Therapeutics Inc
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Good afternoon, everyone. 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 go ahead.
Good afternoon, and welcome to our Second 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 the Investor Relations section of our website.
Leading the call today 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 second 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.
Thank you, Al. I’m delighted to report our second quarter results and provide you with an update on the recent exciting developments at Halozyme that are positioning the company for sustained growth in revenues, earnings and cash flow in the coming years. These developments included three major market regulatory approvals for blockbuster oncology drugs utilizing our ENHANZE direct delivery technology and our first quarter of what we expect to be sustained profitability going forward.
And before we get to some of these exciting second quarter developments, I’d like to provide a brief update on the impact of COVID-19 on our business. As an organization, we continue to operate effectively with the majority of our employees working from home. We expect this will continue for the foreseeable future. Importantly, our suppliers also continue to operate without interruptions related to COVID-19. On our first quarter call, we indicated that based on partners feedback, we anticipated that some partner development program starts would be delayed by one to two quarters, and that some trial enrollment had been impacted. Any potential for impact on FDA and EMA review times was unknown at that time.
I’m very pleased to update today that progress has been made on multiple programs during the second quarter. And based on latest partner feedback provided just in the last few weeks, we predict a total of nine new clinical trial starts in 2020 with one additional new trial start date still uncertain. From a regulatory standpoint, we were obviously pleased by the speed with which the FDA was able to approve Janssen’s DARZALEX FASPRO and also Roche’s Phesgo. The Phesgo approval was four months ahead of the October PDUFA date and the FDA cited that this was due to a desire to expedite oncology product development.
In Europe, the EMA timeline for DARZALEX SC approval also tracked ahead of expectations. Now these current expectations for 2020 reflect the latest feedback we’ve received from our partners about their plans for their ENHANZE based products in 2020. Given the inherent uncertainty of the COVID-19 pandemic, our partners may update or change their plans or outlook in the future. We’re monitoring this closely and would provide updates if there were to be any changes impacting the business.
Now, let me turn to the great news on the quarter, beginning with Slide 3. Our partners received two FDA approvals and one EMA approval during the second quarter, bringing the total number of FDA approved drugs utilizing our ENHANZE technology to five. Most recently, Roche announced they received FDA approval for Phesgo a fixed-dose combination of two Roche drugs that are the backbone of treatment for HER2 positive breast cancer patients Perjeta and Herceptin. In terms of demonstrating the power of our ENHANZE technology and its ability to provide competitive differentiation, Phesgo is the first combination of two monoclonal antibodies in a single subcutaneous injection utilizing the ENHANZE technology. This fixed-dose combination can now be administered in approximately eight minutes for the initial loading dose and approximately five minutes for each subsequent dose.
This compares to approximately 2.5 hours for the initial and fusion loading dose because of the sequential injection of Perjeta, then Herceptin IV and between 1 to 2.5 hours for the subsequent infusions all of these two medicines. The FDA granted approval of Phesgo in new adjuvant and the metastatic treatment settings based on the FeDeriCa study, which was an open-label, multicenter randomized study conducted in 500 patients with HER2 overexpressing early breast cancer in the neoadjuvant and adjuvant setting. This once again supports FDA comments made at the Rituxan Hycela ODAC that a separate controlled clinical study may not be needed for each and every indication.
In addition to the FDA acting swiftly on this application, the agency highlighted the potential for this product to be administered in the home by healthcare professionals, which adds an important outpatient option for patients. Now, this is especially true in the current circumstances where reports suggest some patients do not wish to visit hospitals to receive their treatments, due to COVID-19. Highlighting further the potential appeal to patients, Roche also conducted a Phase 2 title Zane Francesca [ph], which evaluate the patient preferences and found that 85% of patients preferred the subcutaneous fixed-dose combination of Perjeta and Herceptin over the IV.
Looking ahead, Roche completed regulatory submissions for the fixed-dose combination of Perjeta and Herceptin in Europe, and a decision by the EMA is expected in 2021, assuming a standard review time. In terms of understanding the potential opportunity of Phesgo for Halozyme, one needs to consider the Perjeta sales plus associated Herceptin sales, as Phesgo can replace the individual use of both of these drugs in the breast cancer indications. Analyst consensus predicts global sales of Perjeta of $4.1 billion in 2020, growing to $5.6 billion in 2024. Breaking this down some more, in the U.S. Perjeta alone was $1.6 billion in sales in 2019. One would then add the associated Herceptin sales in breast cancer to understand the total opportunity. For Europe, for a regulatory decision is expected in 2021. European sales of Perjeta in 2019 represented about 70% of the sales of the U.S. International sales made up the remainder of the approximately $3.8 billion in total sales in 2019 with international representing about 60% of U.S. sales.
Let me move now to Slide 4 on DARZALEX SC. As discussed on our last call, Janssen received FDA approval for DARZALEX FASPRO on May 1, with a broad label covering five of the seven indications for which the IV form is currently approved. We estimate this label allows DARZALEX FASPRO utilizing ENHANZE to address the majority of multiple myeloma patients based on our assessment of analyst estimates for how DARZALEX IV is used today.
One of the indications for data was awaited was for using combination with pomalidomide and dexamethasone. Just days ago on July 31, Janssen’s development partner Genmab announced positive top line results from the Phase 3 APOLLO Study, which was evaluating subcutaneous daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The study met the primary endpoint of improving progression free survival and the safety profile daratumumab SC in combination with pomalidomide and dexamethasone was reported to be consistent with the safety profile for each therapy separately. We look forward to this data being presented at a future medical meeting.
On June 4, we announced that European Commission granted Janssen European marketing authorization for the subcutaneous form of DARZALEX. The authorization included alternately approved DARZALEX IV formulation indications in frontline and the relapsed and refractory multiple myeloma settings. Shortly after these approvals, the subcutaneous form of DARZALEX was launched in each market. And the first commercial sales resulted in milestone payments to Halozyme of $15 million for the U.S. and $10 million for Europe. Continuing with approval just last week on August 4, Janssen announced that Health Canada approved DARZALEX SC in four regimens, across five indications in patients with multiple myeloma, including in newly diagnosed, transplant-ineligible patients and also relapsed and refractory.
Now let me move to the launch progress. It’s clearly, obviously still very early days and there’s little detailed information I can share at this time. And what we can say that is that on the second quarter 2020 financial results call, JNJ commented that it was pleased with the uptake it was seeing for subcutaneous DARZALEX and the benefits it provides to patients and the healthcare providers. The value proposition offered by subcutaneous form of DARZALEX is strong. It provides the ability to reduce the administration time from what is often 4 to 6 hours for the IV form of daratumumab, because 3 to 5 minutes for the subq. This can reduce treatment burden for patients and caregivers, as well as provide value to the healthcare system where we hear time and time again, all the constraints on the infusion center pasty and the challenges we’re providing nursing oversight for long infusions.
Turning now to the market opportunity for the subcutaneous form of DARZALEX. Analysts currently project sales for DARZALEX of $3.9 billion in 2020 growing to $6.8 billion in 2024. Now this growth is projected to come from increasing penetration into the frontline setting. Janssen has stated, the subcutaneous formulation of DARZALEX utilizing ENHANZE is a core part of their future growth strategy, supporting their goals for this expansion into the frontline setting, in addition to increasing treatment in the community setting.
Now just to close DARZALEX, I also want to highlight on the positive Phase 3 data from the ANDROMEDA study, which was in light-chain amyloidosis. This data was reported in June and was presented at the European Hematology Association Meeting on June 14. There were approximately between 30,000 and 45,000 patients in the United States and the European Union who have light-chain amyloidosis and treatment options are limited today. This is the first ever study evaluating DARZALEX in this indication, and we’re delighted that only the subq version of DARZALEX with ENHANZE was selected to be studied.
Importantly, when DARZALEX SC with ENHANZE was given in combination with cyclophosphamide, bortezomib and dexamethazone or CyBorD at compared to CyBorD alone, the response rate was 53% compared with 18%, a very strong result. Janssen had stated that looking forward to pursuing regulatory submissions with the health authorities. We’re certainly very excited by these three approvals by global regulatory authorities and that they were granted in such a timely manner and no offer patients suffering from breast cancer and multiple myeloma new treatment options that can reduce the treatment burden. And we’ll look forward to providing further updates on the progress of these launches and also as we gain additional approvals in additional regions and indications.
Let me move now to Slide 5 into our currently commercialized products in the U.S. and Europe. Roche continues with its global commercialization of MabThera or Rituxan Hycela and subcutaneous Herceptin or Herceptin Hylecta. Relative revenues from these more mature products are anticipated to decline modestly this year, primarily as a result of the ongoing impact from biosimilars, with Roche also reporting some impact from the COVID-19 pandemic.
Now, adding to these revenues will be Phesgo DARZALEX FASPRO in the U.S. and DARZALEX SC in Europe. As we’ve noticed in the past, we expect 2020 to be a year where Janssen and Roche will focus on gaining access and reimbursement for these new products. In the U.S. it is typically a multi-month period required for full access to be established as new products gain formulary approvals and inclusion into the prescribing orders in the electronic medical records.
In Europe, gaining reimbursement approval is the key next step. And this can take between six to nine months in several of the key European markets. As a result, we expect DARZALEX and Phesgo to contribute modestly to royalties this year with an expectation that everything will be in place for robust uptake in 2021. Completing our update on royalties, I’m also pleased to report that one of our earliest approved product HYQVIA, now commercialized by Takeda received a positive opinion by the CHMP last month to expand the HYQVIA label in Europe to include the indication of secondary immunodeficiencies. Upon EMA approval, Takeda will be able to target the segment of the market, which Takeda has reported and estimated to represent about 15% of being global in use in the U.S. and Europe.
As we look at our expectations for the year, balancing the anticipated declines in the more mature products with the new product launches, we know anticipate royalties in 2020 will be roughly flat with last year.
Let me move now to our development products, which are shown in Slide 6, where you can see a summary, all of the pipeline products that are being developed, utilizing ENHANZE. As I mentioned earlier, we expect a total of nine new trial starts in 2020, and we continue to expect three new Phase 3 trial starts. These will come from the list it’s showing here on the left of the completed or ongoing Phase 1 study. For the competitive reasons, recall our partners do not announce their plans until the trials are ready to start.
And we’ve already achieved our goal of one new Phase 2 trials starts for the year with argenx initiating a study with efgartigimod in CIDP. And we continue to expect a total of five new Phase 1 trial starts with one additional Phase 1 trial start delayed, currently uncertain due to COVID-19. As you’ll hear in a moment, two of these five Phase 1 starts has already begun since our last call.
Let me now provide a bit of color by partner. As we announced last quarter, argenx has initiated a Phase 2 study with efgartigimod in CIDP. On its most recent quarterly call, argenx provided an update that it’s go, no-go decision regarding potential advancement to Phase 3, after the enrollment of 30 patients in Part A of this trial is expected to occur in 2021. In May, argenx announce that it’s Phase 3 ADAPT study evaluating the intravenous form of efgartigimod in myasthenia gravis patients met its primary endpoint. Based on these positive results, argenx has stated that it plans to discuss a bridging strategy for efgartigimod SC with ENHANZE in myasthenia gravis with the FDA in the fourth quarter of this year. And lastly, for argenx, we’re pleased to report that the first patient has been dosed in the Phase 1 study of ARGX-117 utilizing ENHANZE. ARGX-117 is an antibody that binds to C2 with the potential to reduce tissue inflammation and the adaptive immune response.
Moving to Bristol Myers Squibb now, they continue with Phase 1 development of nivolumab anti-CD-73 and relatlimab in combination with nivolumab. I’m delighted to announce that Bristol has now also initiated a Phase 1/2 of ipilimumab in combination with nivolumab using our ENHANZE technology. This takes a number of targets in development by BMS now 2024. And Roche continues with its Phase 1 development of Tecentriq and OCREVUS. Now we also look forward to providing more updates as additional programs enter or advance in the clinic.
Let me now comment on our progress on new ENHANZE deals. As I stated last quarter, we continue to have one of the broadest slates of ongoing discussions with both biotech and pharma companies that we’ve ever had. We did see some impact from the COVID-19 pandemic in our pace of our discussions in Q1 and early Q2. I’m really pleased to see that the pace of these discussions has returned to normal. And based on the slate of opportunities, I remain confident that we will sign additional deals, as ever it’s the timing, it’s hard to predict.
Now let me return to our anticipated growth in milestone revenues, as shown on Slide 7. The progress of ENHANZE portfolio is predicted to drive the strong growth in milestone revenues between now and the end of 2022. Based on the latest information from partners, we continue to project cumulative milestone revenues in the next three years of between $350 million and $450 million. This growth and projected milestone revenues was being driven by the larger milestone payments associated with new target approvals and the increase in the number of products advancing to later-stage development. Many of which are also associated with larger milestones.
Now this near term milestone revenue precedes the royalty revenues, and is also an important and strong indicator for our future royalty revenue potential, which we predict to be approximately $1 billion in 2027, based on the non-risk-adjusted revenue projections for the programs that are currently in or planning for development.
Let me turn now to Slide 8 and review our approach for value creation and capital return. Our first priority remains to drive the growth in our ENHANZE business by maximizing the value of our current collaboration and working design in new collaboration partners. With this strong projected free cash flow, our next goal is returning capital to investors via share repurchases with our three-year $550 million repurchase plan. In addition, we continue to evaluate the potential for new technology platform, expansions through acquisition, but the goal of accelerating our long-term revenue growth. In evaluating this, we’re seeking an approach that has a high growth and high margin light our ENHANZE business.
And with that overview on update, I’ll now please to turn the call over to Elaine for a discussion of our second quarter financial results.
Thank you, Helen. I’ll turn to Slide 9 for a review of our second quarter revenues. Total revenue for the second quarter was $55.2 million, an increase of 41% compared to $39.1 million in the prior year period, driven by the significant achievements of ENHANZE based product approvals and launches by our partners.
Royalty revenue for the quarter was $15.8 million, a decrease of 12% driven primarily by the ongoing impact of competition from biosimilars and the impact of COVID-19 on Roche’s sales. As royalties from new partner product approvals begin to ramp. This should offset the impact from biosimilar competition affecting the more mature partner products over the balance of the year.
Product sales were $6.3 million in the quarter, representing an increase of 10% from the prior year period. We continue to expect the product sales of API will fluctuate on a quarter-to-quarter basis, depending on the needs of our collaboration partners. Collaboration revenue in the quarter totaled $33 million, more than double the prior year period driven by the two Janssen milestones related to the launches of subcutaneous DARZALEX in the U.S. and the EU, which totaled $25 million in the quarter. In addition, we received $5 million related to conversion of an option from a co-exclusive license to an exclusive license by our partner BMS.
On Slide 10, you’ll find a more detailed breakdown of our second quarter P&L. Let me begin with total operating expenses, which were $25.7 million in the second quarter, down 52% from $53.1 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 delivering technology in November of last year and related restructuring, which has now been completed.
Cost of product sales were $5.7 million, up from $1.9 million in the year ago period. This increase was principally driven by sales of both rHuPH20 to certain of our partners and an increase in cost to support our product platform and serve our partners’ supply need. Research and development expenses of $9 million decreased by 74% from $33.9 million in the prior year period, as a result of halting our PEGPH20 oncology drug development activities in November of last year. We’ve been working to finalize the close out of remaining costs associated with our prior clinical trial activities and completed our restructuring of the company’s operations in the second quarter to focus solely on ENHANZE.
SG&A expenses were $11 million down from $17.3 million in the prior year, primarily due to the reduction in force and discontinuation of PEGPH20 related launch expenses that were part of the company’s restructuring. And I’m pleased to say that our net income for the quarter was $25.8 million or $0.19 per share compared to a net loss of $14.6 million or $0.10 per share in the second quarter of 2019. And we expect this will be the beginning of sustainable profitability and cash flow generation for Halozyme.
Cash, cash equivalents, and marketable securities are $385.4 million at June 30, 2020 compared to $421.3 million at December 31, 2019, this decrease reflect the impacts from our operating loss and share repurchase activities during the first half of 2020.
Now we’ll turn to Slide 11 for our discussion of our 2020 financial guidance. We continually monitor the impact of the COVID-19 pandemic on our business and communicate with our partners and suppliers after their plans and timeline. And based on that latest information and our planned expenditures for the year, our guidance for 2020 remains unchanged. We continue to expect total revenues to be in the range of $230 million to $245 million. And earnings per share, is expected to be in the range of $0.60 to $0.75.
Excluding non-recurring expenses related to the wind down of our former oncology operations in the first half of 2020, we expect annualized operating expenses, excluding costs 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. Including those non-recurring expenses, full year 2020 operating expenses excluding COGS will be above $75 million.
With regard to interest expense related to our convertible senior notes offering in November 2019, we expect to book quarterly interest expense of $5 million or $20 million total for the fiscal year. We understand that certain elements of our business impose a challenge for modeling Halozyme earning on a quarter-to-quarter basis and to assist with this, let me now provide some color on the anticipated quarterly progression of our top line.
Collaborative revenues related to milestone payments are inherently variable. However, based on current partner plans, we expect a higher level of collaborative revenues in the fourth quarter than in the third quarter of 2020. Product sales related to API are expected to be flat from Q2 to Q3 and then increased in the fourth quarter. Growth from royalties from new partner product launches are expected to offset pressure on royalties for more mature partner products. And that is expected to result in higher earnings per share in the fourth quarter than in the third quarter of 2020.
With strong cash flow generation anticipated to be provided by a broad portfolio of ENHANZE partner products over time, we expect to be able to continue our $550 million three-year share repurchase program that was authorized by our Board of Directors in November of 2019. To date, we’ve completed approximately $254 million in share repurchases, of which we repurchased approximately $54 million in 2020, including $2 million worth of our common stock in the second quarter. Our average repurchase price year-to-date is $16.33.
Even our confidence in our long-term prospects and commitment to providing long-term value for our shareholders, we anticipate repurchasing up to another $296 million available under the program between now and the end of 2022. In addition to utilizing our free cash flow to support both internal and external growth initiatives. Of this amount remaining under the program, we continue to plan to repurchase up to $96 million worth of shares during 2020 depending market conditions and other factors.
With that, I’ll now turn the call back to Helen.
Thanks, Elaine. This has been one of the most important quarters in Halozyme history. Not only did our partners receive three critical regulatory approvals for high growth products that are expected to be important growth drivers of our royalty revenues in the coming years, we also achieved our first quarter of what we expect to be sustainable profitability. Despite the challenging times facing all companies, we are delighted to be in a position to maintain our financial outlook for the year.
With two new commercial products utilizing ENHANZE now available, we are more dedicated than ever to serving patients and the healthcare system aligned with our disruptive solutions, with the goal of improving patient experiences and outcomes. And we’re also in the strongest financial position ever as a company, will it forward to strong in our revenues, profitability and cash flow in the coming quarters and years placing us in a strong position to deliver on our commitment, to return capital to shareholders, maintain our long-term sustainable growth and maximize shareholder value.
And even though, we’ve already achieved a number of very important milestone events thus far in 2020, as you can see outlined on Slide 12, there are many more anticipated for the remainder of the year. These include continued momentum in the clinic, which is so critical for our partner products that utilize ENHANZE, which is leading to nine new clinical trial starts in total in 2020 of which three are expected to be Phase 3 trials starts. And none of this would be possible without our talented and dedicated team here at Halozyme. I’d like to end by thanking everyone for your tremendous efforts and these strong results.
I would now be delighted to take your question. So operator, please, would you open up the call?
[Operator Instructions] Your first question comes from the line of Jim Birchenough from Wells Fargo.
Hi guys. Congratulations on your first profitable quarter and all the other progress over the course of the year so far. A couple of questions, I guess, first Helen, you’ve had the $1 billion royalty target for 2027 for some time, I don’t expect you’re going to update that and go beyond that today. But could you give us a sense that, there seems to be some concern that post 2027 things could be challenged? But maybe as you consider DARZALEX, subcu IP and Perjeta, Herceptin IP and other products in the pipeline, what sort of growth do you see beyond 2027?
Yes. Thanks, Jim. 2027, seven years ago, while we were showing this, that tremendous projection of growth, which is really driven by the number of product launches that we’re anticipating will happen. As we’ve said in the past the shape of the curve post 2027 is very much going to be influenced by how many new products we launched between now and 2027 and how many new co-formulation patents we get. The current projection of $1 billion is just based on the products we currently have line of sight to, and we already have line of sight to additional products in 2021 that are going to move into the clinic and a lowest to continue to grow past 2027, in terms of them contributing revenue, because if you recall, in terms of our royalty term, it is a minimal over 10 years.
And so it’s too early to be absolutely sure what’s going to happen after 2027. But what we can say with certainty is we don’t have the traditional royalty cliff because of the co-formulation patents allowing for more than 10 years of royalties, because we will have additional launches in the next year that will extend past 2027. There is a very strong possibility we can achieve continued revenue growth past that time or a flattening of revenue. But certainly, I can be very confident does not going to be a traditional royalty cliff.
And then Helen, just on the potential for additional deals and maybe with the current COVID environment, it seems like infusion capabilities are challenged, particularly as states are surging with the virus. Are you seeing any of that drive increase in partner trust? Or are you seeing the COVID environment and the impact on IV infusions impacting potential for deals?
Yes. We started the year with a good deal of interest in new deals. Jim, I would say, it’s only increased as COVID hazards, you see impacted hospitals and patient willingness to go to hospitals. So we have a very broad, broad slate of interesting opportunities ahead of us, both with biotech and with pharma. So I’m very confident we will sign additional deals. It is always just hard to pay exactly when those new deals would happen. But to add to your point about COVID-19 driving interests, I would say that the launches and the value propositions demonstrated with DARZALEX FASPRO and with Phesgo have also generated a lot interesting questions. When you think about the ability to take a four to six hour IV infusion than to just three to five minutes, that has many companies intrigued and the ability to combine two antibodies in a single injection given in five minutes, it’s also a new demonstration of an incredible value proposition. So all of those factors are leading to a great series of discussions and I’m very confident we will have a deal.
Terrific. Thanks, Helen.
Next question comes from the line of Graig Suvannavejh of Goldman Sachs. Please go ahead.
Great. Thank you. Thanks for taking the questions and congrats on the progress. I just wanted to maybe touch base on the share repurchase program and given where the stock is today, where we’ve seen a nice run up to current levels versus your average purchase price in the first quarter. How were you thinking about how to pull that trigger at what prices? So just color on how you think about like, I guess, portfolio manager, so to speak. And then I’ll have a follow-up after that. Thanks.
All right. Elaine, would you like to address the share repurchase?
Sure. So Greg, with respect to the specific size and timing of repurchases, we obviously take into account a host of factors including impending partner events, market conditions, our stock price, and other factors. What I would emphasize for you is that we remain committed to our three-year $550 million capital return program. And we’re continuing to drive toward the goal of repurchasing up to $150 million of our common stock this year. Recall we’ve already purchased $54 million of our common stock year-to-date, and obviously focused on [Audio Dip] value to shareholders consistent with what we’ve previously communicated to investors.
Thank you very much for that. Maybe another question I have just has to do on your search for additive technologies and wondering if there’s been any considerable or new developments since the last time we checked in?
Yes, Graig. No new developments we are actively searching and evaluating different platforms. As we’ve mentioned in the past week, we don’t feel any urgency to do that. We’ve got a great ENHANZE growth story ahead of us. But what we want to do is seek to see and can we accelerate that revenue growth. So what we’re doing is evaluating a whole range of technologies and platforms. And there’s some interesting things out there, but we’re pretty early on in our investigation of those. And we will let we’ll provide the appropriate updates. So when we do find that the right thing, if we find it.
Great. Maybe just one last one for me, please. The Phase 1/2 study of ipilimumab in combination with nivo, I’m just wondering as we think about that particular clinical trial start, and then some of the other clinical trials starts that are more Phase 1 in nature that are expected throughout the balance of the year. I’m just wondering, what if there are certain milestones that we should think that would be associated with such early clinical trials? Are the milestones that you’re expecting really more associated in way towards the later the Phase 3 types of trials? Thanks.
Yes. It is a range. With regard to those, I ask Elaine, just to give – just brief overview as to the milestones for the year.
Sure. So as you can imagine, we have regular conversations with our partners and based on that latest feedback, we continue to expect six milestone during study starts including three Phase 3 starts this year. So we continue to have good visibility and competence on our guidance for the year. And the other thing, I noticed that, we benefit from a diversified business bottle with multiple blockbuster products and programs from some of the leading pharma and biotech partners that will be driving our potential milestones and royalties.
Okay. Thank you very much for taking my questions, and congrats again.
And your next question comes from the line of Ike Oji from BMO. Please go ahead.
Good afternoon, everyone. Thanks for taking my question. Congratulations on the successful quarter. We’re just curious about the type of deals that you’re looking at in terms of – it’s been being in partnerships, you kind of developed a pattern of enology, oncology, those types of indications. Are there any types of metrics that you can kind of provide give us a better sense of how many deals that you’re currently in discussions with different biopharma companies?
No specific metrics we can give you and what we do look to assess. And we also have companies coming to us tends to be companies who’ve got an IV product either approved or in development that has got a longer infusion time, whether we’re looking to transform it into subcu or the other area, we ended up in a lot of discussions over current subcu therapies where companies are looking to extend the dosing interval. And so there’s a broad range between currently marketed products, as well as products in development, where people are seeking to optimize a product before they even get to the marketplace.
So if you imagine, and while we have ended up, I think having a lot of oncology drugs with the signing of the deal with argenx, you obviously are seeing us moving more into the immunology, neurology space with working in myasthenia gravis. And there are no therapeutic limitations for ENHANZE we can work in any therapeutic area where somebody has that need for, they have a high volume infusion where we can transform it from IV to subcu, or we can allow them to deliver a higher dose of the subcu that can perhaps extend the dosing interval. So it’s very broad applicability, not limited by therapeutic area.
Okay. That’s helpful. Just a quick follow-up to that. Is there a target in mind that you guys have in terms of how many deals you do want to executed over the course of a specific timeline, maybe the next three or four years? We want to execute maybe three to four deals that might lead to $1 billion in total revenues 2029 or so on and so forth. Is there any type of guidance that you provide on that?
No specific guidance or goals. We do believe there are multiple additional deals that we can have. We can never give you specific timing for the goals, because that really is under the control of the company. But if you’re thinking over the next several years, I definitely expect to see several additional deals consummated over the next several years, but exactly what the timeframe is. It’s just hard for us to predict and control.
Okay. That’s fair. I appreciate, Helen. Thanks for taking my questions.
Okay. Thank you.
Next question comes from the line of Sean Meakim from Citi.
Hi. This Sean Meakim calling in for Joel. Thanks for the update today and for taking my questions. Two for me today. Maybe can you characterize what gating steps remain for – as you think about patients converting from IV to subq DARZALEX? What are kind of the main inflection points and what should investors be looking at in regards to that? And I have a follow-up question as well.
As I mentioned in my prepared remarks that we’re obviously delighted with the approval of DARZALEX FASPRO in the U.S. and DARZALEX SC in Europe. In each of these cases, there are always some steps, just as sure full access and reimbursement. In the U.S., it is things like getting onto formularies and getting loaded into the writing orders on the electronic medical records. That I’m sure is well underway. It just takes a while for that to all be completed. And when that is completed, then obviously there could be free writing by all physicians, so always a process. We expect DARZALEX FASPRO to mirror all of the recent injectable launches.
For Europe, the key gate is gaining reimbursement in each of the key markets. It’s a very well defined and well understood process. And obviously Janssen has got deep experience doing it. So in some of those markets, it can take between six and nine months to complete that process, but that is a process Janssen will already have started. And we’ll just follow again, what is a standard approach for injectable drug approvals in Europe as well.
Inflection points, I think what we’re going to see as we usually see with injectable launches is as more patients and physicians get full access to the drug, you tend to see over time, just a gradual increase in the new orders that are written every week. And then when the free access comes, you see an acceleration in that growth rate. So I’d point you to recent successful injectable launches, and that’s exact – clearly what I would expect to see with DARZALEX.
Thank you for all of that, Helen. And then just one brief follow-up. Now that you have multiple partner products showing data and kind of additional indications, can you remind us how the royalties are set up for HALO? If label expansion is granted and additional IP is granted for agents, how do that work?
Yes. So we received on average mid single digit royalty on net sales. That will last till the last expiring specified rHuPH20 patent or for 10 years after the first commercial sale. Now if the patents expire during that 10 year period, that would be a step down in the royalty rate to about 50% of that. And so that’s the base plan. Now we do have this wonderful benefit that if co-formulation patents are granted they generally have a favorable effect on the lens of the royalty term and they can, depending on which partner is also delayed time to the step d own. So each case in our portfolio is going to be a little bit different. But the great news is that for all of our products there is always a minimum of at least 10 years of the royalty term. And it’s often longer than that due to the co-formulation patents that can be granted.
Perfect. Thank you so much.
Thank you.
And we have a follow-up question from Jim Birchenough from Wells Fargo.
Yes. Thanks for the follow-up. So just on the co-formulation work that supported the approval of Herceptin, Perjeta or Phesgo. How much as that a driver potentially have additional deals? It just seems like one of the trends in oncology is immuno-oncology combinations with PD-1 as a backbone and PD-1 plus other things like CD47 antibodies. And so, could you maybe talk A, about a co-formulation work you’re doing for things like if we nivo other co-formulated products with Bristol and more broadly, whether co-formulation with that recent approval could be one of the themes of your further deals.
Yes. And so Jim, you are really talking about times where we’re taking in hands with two wonderful antibodies and you’re absolutely right, Perjeta, Herceptin is the first approved one. Bristol is in the clinic with ipilimumab plus nivolumab, that’s the new one that started, but they already last year – a few months ago had started the study with belantamab with nivolumab as well, which is their like three with the PD-1. And certainly if you recall back when Bristol signed that deal with us, this was their vision. Their vision was that in the future oncology therapy with the immune checkpoint inhibitors would be combination, it could be delivered more simply in the community setting or even potentially in the future at home. And so it is wonderful that the ENHANZE technology is allowing this to begin happening.
Those are the only programs we can talk about, but if you want to expand this a little bit, there’s also the possibility there being two separate drugs, but bispecific is another area where not quite the same, but I want you to think about that as well as another opportunity where ENHANZE has the potential to be allowing these drugs to be given in a subq as well. So we do see this as definitely a trend that is increasing. And we certainly get a lot of interest from people in understanding how it is done, how hard it is and what are any of the considerations with that.
And Helen, just to confirm that the combinations with Bristol those are co-formulated or are they separate injections?
The intent will be co-formulated? Yes. They’re co-formulated. The only product we have the receptor injection is HYQVIA.
And then just a final question relating to this topic for Herceptin, Perjeta the stability of the two antibodies in a co-formulated product, I think is the basis of extended IP. Is that a possibility with some of these other programs, these other combos?
The way the co-formulation patents works as if there is some novelty that is unique to that formulation. So if there was a stability that was not identical to what was the result of the patent for the Perjeta, Herceptin, yes, it could. It just has to be novel Jim. And so with each of our partners, we sit down and we look at the data, we look at what is unexpected, what is novel and that is the focus of the conversation for submitting the applications for co-formulation grants.
Very well, thanks for taking the follow-up.
Okay. Thank you.
[Operator Instructions]
All right. Operator, it sounds like there may be no additional questions. So with that it’s my pleasure to close the call. And just recite again on what an important quarter this has been for Halozyme to see such a breadth of products in the clinic to see three important regulatory approvals and to achieve what is our first quarter of expected sustainable profitability is I think a terrific set of accomplishments. We appreciate you for your ongoing support. And look forward to providing further updates in the next quarter. Thank you so much.
This concludes today’s conference call. Thank you for your participation. You may now disconnect.