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spk00: Ladies and gentlemen, thank you for standing by, and welcome to the HaloZyme fourth quarter 2020 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. Thank you. I would now like to turn the conference over to Al Kildani, Vice President of Investor Relations and Corporate Communications for Halo Zion Therapeutics. Mr. Kildani, please begin.
spk09: Thank you. Good afternoon and welcome to our fourth quarter and full year 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 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 fourth quarter and full year 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.
spk04: Thank you, Al. 2020 marked a year of tremendous growth for Haleland, which has created strong momentum as we enter 2021. Let me begin with a brief review of the 2020 performance. Total revenues in 2020 were $267.6 million, up 37% from 2019, and our earnings per share were $0.91. Both revenue and earnings per share were within our most recent financial guidance range. Our strong financial results kept a transformational year for Hanazan that saw a number of significant accomplishments. These included the two SBA approvals and two European Commission approvals for enhanced-based products, including Janssen's subcutaneous form of Darzalex and Roche's Bezgo. A return to royalty revenue growth driven by the strong uptake of subcutaneous Darzalex, which is known as Darzalex Faspro in the U.S. and Darzalex SC in Europe. The expansion of our development pipeline, including two products moving into phase three development. The signing of a new enhanced partnership with Horizon Therapeutics to develop a sub-QT and its version of CAPESA. And continued execution of our capital return program, resulting in $150 million in share repurchases during 2020 for a total of $350 million share repurchases since the board authorized this three-year $550 million plan in November of 2019. This remarkable progress in 2020 was achieved against the backdrop of the global COVID pandemic, a challenge we were able to navigate thanks to the hard work and dedication of our partners, suppliers, and employees. The progress and expansion of our enhanced partner pipeline provides confidence in the potential of our long-term growth prospects as we anticipate the potential for multiple waves of product launches in the upcoming years. Moving now to 2021, We expect revenues of $375 to $395 million, which would represent growth of 40% to 48%, driven primarily by an expected doubling in royalty revenue. The expected gap earnings per share of $1.40 to $1.55 would represent growth of 54% to 70%. Recall that our guidance does not include any contribution from potential new enhanced deals. Let me now turn to slide three for a discussion of our royalty revenue growth. In 2021, we projected doubling in royalty revenues. This strong growth is driven by both subcutaneous Darzalex and Fezgo. As illustrated in the left-hand chart, in the fourth quarter, we saw revenue from royalties grow 86% year over year and 34% sequentially. This growth was propelled by the launch of Darflex FASPRO in the US and Darflex SC outside the US and resulted in full-year 2020 royalty revenue of $88.6 million. For 2021, we project Darflex FASPRO and Darflex SC growth will continue, driven by ongoing adoption and penetration in the already launched markets and by additional launches around the world. For Fesco, we project robust growth in 2021, driven by increased adoption and penetration in the US, and also by the start of the European launches, following the European Commission approval in December of 2020. For full year 2021, with the strong 2020 launch, we project that sustaining star selects will remain the key driver of royalty revenues at a level that is substantially higher than Fesco. We're now in a position where the high margin recurring portion of our revenues is also the fastest growing segment. Let me turn now to slide four, and I'll highlight our key commercialized products. We have five products now approved in both the U.S. and Europe utilizing our enhanced technology. Let me now provide some color on the most recent product launches, representing our Wave 2 launches, beginning with subcutaneous Darzalex. During the fourth quarter, Janssen's parents, Johnson & Johnson, reported worldwide sales of Darvoix, including the IV and SC forms, of $1.25 billion, up 49% year-over-year on an operational basis. While J&J does not provide a breakdown of sales between the IV form of the drug and the subcutaneous form utilizing in hand, we can share, based on data from Symphony Health, that by October of 2020, just five months after the May approval, 40% share of sales of overall darsalic in the United States was the subcutaneous version. I think you'll agree this is a remarkably fast update and really speaks to the value proposition that the subcutaneous version can bring for patients. Supporting the impressive growth expectations are also potential additional approvals and launches in new countries and indication expansion for subcutaneous Darzalex. These opportunities include the potential approval of the subcutaneous form of Darzalex in Japan for multiple myeloma patients, Potential growth from sales in the newly approved indication of newly diagnosed adults with light-chain amyloidosis following U.S. FDA accelerated approval in January of 2021 for the use of DARS-led Spaspro in this indication. In this indication, it's used with bortezomib, cyclophosphamide, and dexamethasone. Consistent with this being an accelerated approval, Janssen will conduct confirmatory trials while the therapy is made available in the U.S. to the indicated patients. And there's also the potential for approval and launch in light chain amyloidosis in Europe. And additionally, there's the potential for U.S. and European approval for subcutaneous Darzalex utilizing a hand in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who've received at least one prior line of therapy. With the launch of Substantaneous Darzalex off such a strong start, high growth in the overall Darzalex franchise, and the anticipation for expanding indications and geographies, you can see why we expect Substantaneous Darzalex to be a strong driver of revenue growth for Halazine. Let me move now to Feltil. This is a fixed dose combination of two abrasive antibodies, Progetta and Herceptin, which is administered in five to eight minutes compared to several hours needed for the IV version. Fesco was launched in the United States in the third quarter of 2020 and was approved in Europe in late December, with loans expected to begin during the first quarter of 2021. For the fourth quarter, Roche reported Fesco sales of approximately 16 million Swiss francs. With the European launch beginning in Q1 and the expectation of increased adoption and use in the United States, we anticipate strong growth in Fezbo sales and contribution to Kayla Zambrosi in 2021. Let me now move to slide five and a discussion of the enhanced development portfolio. Building on our portfolio of five commercialized partner products, we predict the expansion of our development pipeline to now 16 products by the end of 2021. with an expected five new Phase I study starts. In June of 2020, Dr. Samara Squibb initiated a Phase I-II study of ipilimumab in combination with nivolumab utilizing the enhanced technology. BMS recently informed us that they've made a portfolio prioritization decision to not continue the study. BMS will retain the CTLA-4 target for potential future study. In addition, we anticipate two products that are currently in Phase 1 will progress into Phase 3. This would result in a total of four products being evaluated in seven separate indications Phase 3 studies utilizing the enhanced technology by the end of 2021. Based on Halo 5's historical development timeline, these four Phase 3 products form our potential Wave 3 launches, with potential launches occurring in the time window of 2023 to 2025. In addition, we project 12 products will begin or will have completed Phase 1 development in 2021. Based on historical development timelines, if these development programs progress, these 12 products would form the potential wave 4 launches with launch in the time window of 2025 to 2027. We believe this advancing pipeline of products utilizing chance is setting up the potential for multiple waves of future product launches that will deliver long-term growth in revenues, cash flow, and profitability. Let me now just give a brief partner-by-partner discussion of key programs. Beginning with our Janix, which is now conducting four phase three trials for four indications of F-Cortisomide. This really is a remarkable feat achieved in less than two years from deal signing. Earlier this month, Argenix announced that it reached a goal decision for its ADHER trial, evaluating subcutaneous F-cortisomide within hands in chronic inflammatory demyelinating polyneuropathy, or CIDP. Argenix plans to now continue enrollment after the planned efficacy and safety assessment and will include approximately 130 patients to support potential registration of SCF-cortisomide for the treatment of CIDP. During the fourth quarter of 2020, Argenix met with the FDA to discuss the potential for a bridging study for SCF-Cartuzumab in myasthenia gravis, or MG. Recall that earlier in 2020, Argenix announced positive results from its ADAPT trial, evaluating the IV form of F-Cartuzumab in MG. Following FDA feedback, Argenix is moving forward with a small, focused trial designed to enable a fast path to registration for SCF-Cartuzumab. Argenic also recently initiated its Phase III address trial in pemphigus vulgaris and foliaceus, which are two serious skin barrier diseases associated with painful blistering. And Argenic also continues with its fourth potential indication with a Phase III trial evaluating SCF-particomod with enhanced and immune-throated cytopenic purpura. We are delighted to be working with Ergenix on this exciting product, which is one of our potential Wave 3 launches in the 2023 to 2025 timeframe, and which analysts predict could have multi-billion dollar potential. Moving to Ergenix's second nominated target, which is ARGX117. This is being evaluated in a recently initiated Phase 1 study in healthy volunteers with data expected in mid-2021. ARGX117 targets C2 and is planned to be evaluated for the treatment of multifocal motor neuropathy. We expect to receive a milestone payment in the near term related to the subcutaneous component of this study. As we've just heard, Argenix is making rapid progress in the clinic with subcutaneous forms of its drugs utilizing enhanced, evaluating a broad range of potential indications with the goal of accommodating patient preference and to adjust to the new normal for patients who may not always have easy access to all sites of care. During the fourth quarter, we were delighted to expand our collaboration and licensing agreement with Argenix to now include a total of up to six targets. I'll move now to Roche. During the fourth quarter, Roche does the first payment in a Phase III trial, evaluating Dicentric in previously treated locally advanced or metastatic non-small cell lung cancer patients. This is also one of our Wave III potential launch products. In addition, Roche continues with its Phase I study, evaluating SC administration of Ocrimizumab or Ocrevus with Enhance. Moving to Janssen, in addition to the successful launch of subcutaneous form of Darzalex, in November 2020, Janssen initiated a phase one study of amibantanam, EGFR, and met bispecific antibody within hands in advanced solid tumors. Moving on to Bristol-Myers Squibb, Bristol is continuing with an exciting set of immuno-oncology target clinical studies, having publicly announced selection of five of the available 11 targets. BMS has four phase one studies within hands. These include nivolumab SC in two studies, one is a monotherapy and one in combination with SC-relapvinib, as well as studies of subcutaneous anti-CD73 and subcutaneous TIN3. I'll move now to our newest partner, Horizon Therapeutics. In November, we signed a collaboration and licensing agreement with Horizon, providing exclusive access of enhanced for SC formulations of medicines targeting IGF-1R. We received an upfront milestone payment of $30 million. Horizon intends to use Enhance to develop an SC formulation of Tepeza, which is indicated for the treatment of thyroid eye disease, a serious progressive and vision-threatening rare autoimmune disease. The Tepeza franchise has an anticipated peak sales potential of $3.5 billion, according to Horizon. We're pleased with our collaboration with Horizon and look forward to future clinical milestones. Our expanding immaturing pipeline is setting up multiple waves of potential future approvals and launches that can drive long-term revenue growth. Furthermore, we continue to see additional future potential growth from two sources. The first is new enhance deals, where we continue to have a broad slate of discussions with both biotech and pharma companies. As to timing, while I'm confident we will find additional deals as ever, the timing is difficult to predict. And the second source of growth is through our current partners nominating new targets and advancing them into the clinic. With more than 20 open slots available, we're excited for the growth opportunity that exists here too. Now the growth and the progress of our enhanced portfolio is projected to drive strong growth and milestone revenues in the coming years. Illustrated on slide six in the blue bars is our projected milestone outlook over the next three years from 2021 to 2023, as well as comparable three-year outlooks that we presented in each of the prior two years. As shown in the green bars, we're performing well against these projections. For 2021 through 2023, we project $400 to $450 million in milestones, showing a continued progression in the growth of our milestone revenue. Now, this near-term milestone revenue is an important and strong indicator for future royalty revenues. We project royalty revenue potential of approximately $1 billion in 2027, based on our non-risk-adjusted revenue projections for programs we currently have the line of sight to and assuming global sales in all indications. I'll turn now to slide 7 to discuss our approach to value creation and capital returns. We have three capital allocation priorities, maintaining a strong cash balance sheet, share repurchases and internal and external growth. We anticipate the strong projected free cash flow driven by and hand will support both our ongoing commitment to capital return as well as our longer term M&A strategy. As mentioned earlier, we have made strong progress with our three-year $550 million share repurchase program, with $350 million completed to date. We will target repurchasing up to $125 million worth of common shares in 2021, 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 and extending long-term revenue growth. We see opportunity to create incremental value for other platform technologies, applying Halazan's proven partnering and commercialization capability. With Enhanced still early in its growth cycle, we have the opportunity to be highly selective. And with that update, I'll now turn the call over to Elaine for a discussion of the fourth quarter and full year 2020 financial results.
spk05: Thanks very much, Helen. Let me turn to slide eight for a review of our fourth quarter revenues. As Helen indicated, we again saw strong growth in the quarter as our partners continued to execute on their commercial and development plans to establish subcutaneously delivered biologics in the U.S. and globally. Total revenue for the fourth quarter was $121.7 million, an increase of 127% compared to $53.7 million in the prior year period. Let me now take a moment to discuss some of the key drivers of growth. Revenue from royalties for the quarter was $32 million, an 86% increase over the prior year period. This was driven primarily by the continued strong uptake of subcutaneous Darzelec utilizing enhanced by our partner Janssen. Growth in royalties from newly launched partner products, subcutaneous Darvilex and Roche's Fesco, drove overall royalty revenue growth, offsetting the impact of the more mature legacy partner products. Product sales were $32.5 million in the quarter, up 43% from the prior year period product sales of $22.7 million. Growth in product sales was driven by additional manufacturing releases of API in support of our partners' products and programs in the fourth quarter. And collaboration revenue in the quarter totaled $57.3 million, up from $13.7 million in the prior year period, primarily as a result of the $30 million upfront payment for the signing of our collaboration and license agreement with our newest partner, Horizon Therapeutics, in November to develop a subcutaneous TPEZA. Let me turn to slide nine for a more detailed breakdown of our fourth quarter P&L. So I'll start with total operating expenses, which were $44.1 million in the fourth quarter, down 49% from $85.7 million in the prior year period. That overall decrease in total operating expenses resulted from our shift in strategic focus to an enhanced only business model in November of 2019 and related restructuring, which has now been completed. Cost of product sales were $26.3 million compared with $16.7 million in the prior year period, with the increase attributable to the marketly higher level of API sales versus the prior year in support of our partners' products and programs in the fourth quarter. Research and development expenses of $7.4 million decreased 84% from $45.1 million in the prior year period as a result of halting our PEG-PH20 oncology drug development activities in November of 2019. And STNA expenses were $10.4 million, down 56% from $23.9 million in the prior year, primarily due to the reduction in force and discontinuation of PEG-TH20-related launch readiness expenses following our restructuring. Total operating expenses, excluding COGS, were $17.8 million for the fourth quarter, compared with $69 million in the prior year period, With our leverageable business model, fourth quarter operating expenses excluding COGS were just below the estimated range of $18 to $19 million. And that led to operating income for the quarter of $77.6 million compared to an operating loss of $32.1 million in the prior year period. And net income for the quarter was $73.2 million, or 50 cents per share, compared to a net loss of $34.4 million, or a loss of 24 cents per share in the fourth quarter of 2019. And with that, let me turn to slide 10 for a snapshot of the full year 2020 results. Total revenues grew 37% to $267.6 million in 2020 off of an already substantial revenue base. The biggest contributor to this increase was higher collaborative revenues driven by our partners Pipeline Progress and the collaboration with Horizon, which drove a 105% increase in collaboration revenues for the year. And as Helen described, our royalties grew significantly to $88.6 million for the year, 27% over and above 2019. Product sales of $56 million declined slightly given significant API sales in 2019 in support of upcoming partner product launches. And with our highly leverageable business model, we generated $144.3 million in operating income for the year compared with an operating loss of $67.6 million in 2019. Furthermore, net income for the year was a record for Halozyme at $129.1 million compared with a net loss of $72.2 million in 2019. EPS for the year was $0.91 within our most recent guidance range and compared with a loss of $0.50 per share in 2019. With respect to our cash position, cash, cash equivalents, and marketable securities were $368 million at the end of the year compared to $421.3 million at December 31, 2019. This decrease reflects the substantial share repurchases that we have completed to date. Now I'll turn to slide 11 for a discussion of our 2021 financial guidance, which is based on GAAP financials. We plan in future quarters to report both GAAP and non-GAAP financial results. Our guidance is based on the latest information from our partners and our planned expenditures for the year. We expect total revenues of $375 to $395 million, which would represent year-over-year growth of 40% to 48%. Let me speak to the components of revenues. We expect revenues from royalties to double from 2020 levels. We expect product sales to increase between 50% and 60% from 2020 levels, driven primarily by bulk API sales to our partners. We further expect revenue under collaborations to be in a similar range as the 2020 total, driven by new clinical trial starts and commercial milestones. And with regard to operating expenses, I would just know for modeling purposes that the substantially higher product sales we expect will result in a commensurately higher cost of goods, which will be an important factor in your ETF calculation. Total OPEX excluding COGS is expected in the range of $80 to $83 million. And this modest increase from 2020 levels illustrates that strong leverage of our business model. We expect operating income for 2021 to be in the range of $215 million to $235 million, which would represent 49% to 63% growth over 2020. And moving to earnings per share, we are projecting gap EPS of between $1.40 and $1.55, which would represent 54% to 70% growth over 2020. As Helen reviewed, we remain committed to returning capital to shareholders. We continue to expect that we will repurchase up to $125 million in our common stock this year, pending market conditions and other factors, which would leave $75 million worth of shares available for share repurchases remaining under our current authorization. Before closing, I would like to note that we also announced today that we have launched, subject to market conditions, an offering of $500 million of aggregate principal amount of convertible senior notes due 2027. Our intended use of proceeds is to repurchase a portion of our outstanding 1.25% convertible notes due 2024 and the remainder of the proceeds for share buybacks and general corporate purposes. and I would encourage everyone to review the press release that we put out this afternoon. Please note that the current guidance from this earnings call does not contemplate the offering or exchange in the press release I just referenced. And with that, let me now turn the call back to Helen.
spk04: Thank you, Elaine. As you just heard, our developing pipeline coupled with the financial outlook plays a role as I'm in the strongest position ever as a company. We look forward to strong growth in 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 12. While 2020 was clearly a transformative year for Halazan, 2021 is expected to be similarly impactful with several important and value-creating events that are listed on slide 12. We expect the Wave 2 launch momentum to continue with Darzalex FastPro and Darzalex SC continue to grow in US and Europe and potentially also in Japan based on the potential for the approval there in 2021. And we also expect FESGO momentum to accelerate following the European Commission approval in December of 2020. We expect two new products to enter Phase 3, resulting in four ongoing Phase 3 programs across seven separate indications. And recall, these will form the next potential launches in Wave 3. We project five new phase one starts, resulting in 12 phase one products. And we will continue to work to sign new collaboration agreements and advance new targets into development. And as a result of all of this strong progress, we're in a position to return capital to our shareholders through the $125 million share repurchase program, and we will continue to seek to acquire a platform that can add to our long-term revenue growth. None of this progress to date and the future would be possible without the amazing team at HaloLine. And I'd just like to send my sincere thanks to everyone for these terrific results. I thank you everybody for your attention today and we'd now be delighted to take your questions. Operator, please would you open the call?
spk00: As a reminder to ask a question, you will need to press star 1 on your telephone keypad. To withdraw your question, press the back key. Once again, that's star 1 to ask a question. Your first question comes from the line of Charles Duncan from Panther Fitzgerald. Sir, your line is open.
spk03: Hi, Helen and Elaine and team. Congratulations on a very good quarter, and thank you for taking our questions. Thank you. So first question is not on Darzalex. It's on Argenix and F-Cartizumab. And I'm just kind of wondering, it seems like this can become an increasingly – A large part of the story, you know, at least for wave three. Helen, and I'm wondering if you could remind us of quality IP strategy on sub-Q F-Cartismat and how long that may last. And I also wanted to ask about the new targets that were selected by our general.
spk04: Yes, thanks for that question, Sal. And we agree, F-Cortisimod is definitely one of the most exciting products in our portfolio, certainly based on the range of indications they're working in today. With regard to the IP related to the royalty revenues for Halazine, we will continue to receive royalties for 10 years after the first commercial sale. or if there's a co-formulation patent that ever issued for it, that could have the effect of pushing out the royalty duration even longer than that. So two things to talk about co-formulation patents for us, but just as a reminder, based on our contract, it's 10 years after the first commercial sale, and if there are no remaining contracts, patents in place, we would get a step down in the royalty to half of the original rate for the time frame from the last remaining patent to the end of that 10-year term, but certainly a very exciting story ahead for F. curtisimus.
spk03: That's helpful, and I guess it's too early to talk about core formulation patents, and so we'll come back to you. The second question I had regarding our GenX collaboration is the six new targets or up to six targets, and I guess I'm wondering if those have been disclosed or if you could provide us any color to point us to where that might be.
spk04: Yes. So far, they've just selected two of the targets, Chas, so the XDRM target and the C2 target. So, you know, we look forward to continuing to work with our genics and identify additional targets. And obviously, we are very gratified that they already, you know, it's signaled strong interest in expanding the collaboration to up to six targets, but no additional nominations as yet to announce beyond the first two, XDRM and C2.
spk03: Okay, last question, then I'll hop back in the queue, and that is on new collaborations. You've been very productive there with the November Horizon deal. Would you imagine increased visibility on that Tebeza project? SC version progress this year? And then do you have the capacity to bring on new collaborations with the current team and perhaps that being one or two per year?
spk04: Yeah, so with regard to Horizon and Tepesa, if we think back to what the CEO commented on at JP Morgan, they certainly did indicate they're working hard to get into the clinic with that collaboration. We've certainly done our kickoff meeting, and we can expect, I believe, a steady start for that in 2021. With regard to our ability to add new collaboration partners, I think Elaine mentioned this in her prepared remarks. We do have a lean and leverageable business model where individuals at Halogram can support multiple partners at different stages of development. And so we said that we only need a modest expansion in people if we were to see a significant expansion of the number of products in the clinic or a significant expansion in the number of partners. So the current operating expense is a good estimate for the next several years unless we see a big expansion in the number of partners and targets.
spk03: Very good. Thanks for the color. Great quarter. Congrats.
spk04: Thanks, Deb. Appreciate that.
spk00: Your next question comes from the line of Do Kim from BMO. Your line is open.
spk08: Hi, thank you. Good afternoon, and congrats on the quarter. I first wanted to ask about the metrics you provided for Darzalex FastPro, the 40% U.S. share according to Symphony Health. Just want to understand how reliable that data is in your mind, and I assume it aligns with what you're receiving in royalties for FastPro's?
spk04: Yeah, I can talk in general terms about that, though, and say, yes, it does triangulate for us well with the overall numbers that we are seeing. You know, I do think there's always an adjustment from any of these reported syndicate numbers. But the good news is, and this is why we reported it, we see a correlation with the performance we're seeing and the royalty revenues we're receiving.
spk08: And can you comment on launch dynamics for Sezgo and how that compares to Darzalex or FastPro in the US? Are you seeing similar uptake and conversion, or are there differences that we should think about between those two therapies?
spk04: Yeah, I think, you know, based on what Roche has reported as to their overall revenues for Fesgo, they are not getting out the gate as fast as Darzalex Faspro. And I will say that Darzalex Faspro has exceeded our expectations with the speed of adoption in the United States. So, you know, we always expected for Fesgo focusing there that 2020 would be the initial couple of quarters while they get all of the key logistics in place. So things like working on reimbursement, getting on formularies, getting uploaded to the electronic medical records. And it was always our expectation that 2021 would be where we see Fesgo really starting that robust uptake. And so we're standing, I think, very nicely poised for that, to see greater penetration in the U.S., as well as more revenues coming from Europe, which is now only beginning to launch. So, Fezgo, this will be a good year, we believe, for strong growth there. Darth Alex Fast Pro got out of the gate faster than I think any launch I've personally seen. So, they are going to continue that momentum as well and will be the dominant driver of our royalty revenues. But we're going to see a very nice contribution from Fezgo from the two dynamics I just mentioned, though.
spk08: Okay, thank you. That makes sense. Last question on the financials. Just based on your guidance, when you back into the operating expenses for 2021, it seems that we should see an increase in spending for the year. When you look at fourth quarter of 2020, maybe a bottom of the reductions in operating expenses. Where should we expect to see the growth in spending in R&D or SG&A?
spk04: Yeah, let me turn that one over to Elaine to answer.
spk05: So, Joe, we don't provide sort of the breakdown between OPEX, you know, in terms of the breakdown within OPEX. But what I can say is, you know, total OPEX, excluding COGS, we've talked about for 2021 being in the $80 to $83 million range. That's generally consistent with sort of the OPEX for 2020 and, again, reflects our ability to support multiple products and programs of our partners and is obviously down significantly following the restructuring and focus on enhanced-only business. So we'll continue to see good leverage out of our enhanced-only business model, and that should be able to support, again, multiple products and programs, Of course, as Helen indicated, should there be significant expansion in the number of new partners or programs, you know, that could be some expansion over time and some growth with inflation over time. But that's a good number for 21.
spk08: Great. Thanks for taking my question. Absolutely.
spk00: Your next question comes from the line of Gene Birchnell from Wells Fargo. Your line is open.
spk07: Hi, guys. Let me add my congratulations on the quarter and the year. I guess a few questions to me. First, on the convertible note offering, just maybe you could comment on the timing. And there's the suggestion that you'll exchange some portion of the one and a quarter percent notes. And do you expect that to be completely and also just in terms of the mix of shares and cash in that exchange. And then I've got some follow-up questions.
spk04: Let me ask Elaine to address what she can and not answer, Jim.
spk05: Sure. So, unfortunately, Jim, I can't speak too much specifically about the offering. I would refer you to our press release, but you're right. We did discuss an offering of $500 million in new convertible nodes. We've talked about use of proceeds being to repurchase a portion of the of the outstanding convertible notes, as well as for share buybacks under our existing board authorization and tracing our balance sheet for general corporate purposes. So, unfortunately, I can't speak to more specifics than that. I'm just referring to our press release.
spk07: Okay, thanks. And then just in terms of the guidance for royalties doubling in 2021, if you could maybe speak Helen or Elaine, to just the assumptions underlying that and what guides that guidance. Is it feedback you've got from your partners and do you look at a range and take the lower end of that range or the midpoint? Is it based on consensus estimates? Is it based on prior experience with launches in Europe? Just trying to understand what guides that doubling of royalties and how conservative or not that may be.
spk04: Elaine, do you want to address that?
spk05: Sure. So we take, you know, all those factors into account, Jim, as you mentioned. We have a very close relationship with our partners, our alliance management team, and frankly, you know, sort of, you know, across the organization, meet regularly and discuss regularly with our partners to get alignment around the potential outlook for and potential timing of programs and products. So we take both the royalty outlook from our partners. We look at market research as well. We look at, you know, sales statistics from groups like Symphony, et cetera, and we'll look at also analysts. So taking all those factors into consideration, but notably, obviously, our close interactions with our partners gives us confidence that there will be, that we would anticipate, you know, very substantial growth in 2021. And I think we've mentioned, obviously, some of the recently launched partner products, including Janssen, Darzalex, and Roche's Fesco are clearly drivers of that growth.
spk07: Sure. Again, maybe just one final question. I'll jump back in the queue. Just in terms of thinking about the different waves of launch coming up, how do we think about wave three versus wave two? If you could say anything about, you know, as you look at that wave of four products across seven indications, do you think it's comparable to wave two or bigger? Maybe just qualitatively, if you can comment on that.
spk04: Now, you know, the first two potential launches, obviously, are ones we know about, and we're very excited about. That includes F-Cartigimod, we mentioned earlier, as well as Cicendric. Each of those, clearly, as their analyst projections, are multibillion dollars, so very attractive large market. And I can just say, qualitatively, the additional two products that we, I believe, will enter phase three this year as well, are also exciting, established markets, blockbuster products, Jim. So, you know, it's a very exciting group that's in wave three, and obviously strong focus on wave two and the execution there, but wave three is a very exciting wave of portfolio potential launches as well.
spk07: Okay, terrific. Thanks for taking the questions.
spk04: Thank you.
spk00: Your next question comes from the line of Jessica Fai from J.P. Morgan. Your line is open.
spk11: Hey, guys. This is Luke on for Jeff. Thanks for taking my call and your questions today. So just to start, you noted that you expect 2021 royalty revs for FASBRO to be substantially higher than FESGO. Is that driven more as the EU launch for FESGO is just getting underway? Or would you say that's sort of the same dynamic when you look at just the U.S.? ? And then looking long term, do you expect that dynamic to sort of persist, or would you expect them to be at more of an equal level over the long term, just given your comments on controlling how fast FastPro has gotten out of the gate?
spk04: Yeah. Eileen, would you like to address that question?
spk05: I would say, sure. So we see very meaningful growth in Darzalex, Faspro, as we've talked about, and SubQ Darzalex, as we've seen in 2020, and we expect continued growth in 2021. I think Fesco, as we've talked about, 2020 was sort of a year of staging. with getting reimbursement, formulary access, and EMR. And so with those now in place, we do anticipate meaningful growth in 2021. In addition to, as you rightly point out, they received the approval at the end of 2020 in Europe. And so we see Europe also being a driver of increasing sales and royalty growth from FESCO.
spk11: Okay. Um, and then just another one, can you give, uh, you know, any more granularity on timing for the, for the ongoing phase three trials, um, for candidates like eccentric and depends up beyond just them, uh, potentially launching between 2023 and 2025. Um, like, you know, maybe there are ways that they could file for these SCU formulations. And then is there any potential for Effigy Mod to come earlier than that, given the pursuit of rapid path to registration in MG that you guys noted to that?
spk04: Yeah, I will say when we come up with the estimate of them being in the 23 to 2025 timeframe for the wave three launches, it really is based on our standard timelines, which has been four and a half to five years from first in humans. And so the point you made with regard to F-partiginon, if they were for some reason able to have a much faster, smaller, as an example, phase three, that could potentially mean a shorter timeline. And it could potentially mean a launch earlier. I still think those are unknowns. And so we plan conservatively and just link it to our benchmark. But obviously, there is a potential dynamic there. We can't provide any more granularity on the phase three data readouts. Our partners haven't provided that. So we're not in a position to share it. If you take a look at clinicaltrials.gov, you get some estimates there of primary completion dates. But as you know, those aren't always as specific as we would like. But unfortunately, can't provide any granularity until the partners talk about their estimated completion dates.
spk11: All right. Thanks for taking my questions.
spk04: Thank you.
spk00: Your next question comes from the line of Jason Butler from JMP Securities. Your line is open.
spk10: Hi, it's Roy for Jason. Thanks for taking our questions. I guess a couple that tie in maybe with the convertible offering and the buybacks. Do you guys have any thoughts on a potential dividend? And then how are you kind of seeing the M&A environment right now? Are you seeing a lot of assets out there? What do you think about valuations maybe the last five days or so notwithstanding? But what do you think in there? And I had a follow-up on Alexion. Have you guys had any conversations with AstraZeneca? Or do you expect that maybe post-closing in 3Q? Thanks.
spk04: Yeah, let me take two of those, and I'll ask Elaine to talk about the dividend. Alexion and AZ, absolutely. I think that's post the close, so we are just waiting the close before we can have a conversation there, Roy. For M&A, we're still in the assessment phase, looking to see what's out there. There are some interesting things out there, but... I think we're still evaluating the right type of platform, where we want to play and where we can see Helizine's unique talents being able to deliver over and above what the company is able to do today. So definitely an area of active interest for us, but we don't feel in any hurry to do that given the strong growth we see ahead for Enhance, but we're actively analyzing and assessing and looking. Emelian, would you address the dividend question? Sure.
spk05: Happy to. So, Roy, I would just say with our diversified portfolio, strong growth and profitability and cash flow generation, we remain committed to capital return. I think with respect to form of capital return, we have focused on share buybacks. And as you know, we're Very much in the midst of a three-year buyback plan. We're about a little under two-thirds of the way through that $550 million buyback plan. And we've talked about buying up to $125 million of our common stock this year, which would leave $75 million for 2022. While we have made no decisions with respect to going forward beyond that, again, I would say we remain committed to capital return. With respect to dividend versus share buyback, I would say the company is a company with strong growth potential. You know, I would say with Enhance, frankly, still being early in its growth cycle, you know, I would say, you know, share buyback tends to be the sort of mode or method of capital return of companies with that kind of strong growth. And so we, while we've made, again, no decisions about, you know, kind of beyond sort of the current authorization, I think we continue to believe that share buyback is the appropriate method of capital return for a company with not only strong cash flow generation, but also strong growth prospects.
spk10: Okay. Thank you.
spk00: Your next question comes from the line of Anita Dushyant from Barenberg Capital. Your line is open.
spk01: Hi, good afternoon, Helen and team. Thank you for taking my questions. Just a couple more here. Considering the better than expected uptake of fast growth despite the COVID environment, could you talk about the potential of these reformulated therapies eventually moving to an in-home setting? And also regarding the conversion rate of going from IV to STDs, Is there a rate-limiting step in this process, if there is any? All right.
spk04: With regard to the in-home setting, we actually have two products that are approved today for in-home setting, and that would be Hycuvia, which is Takeda's product, and also the Tesco was approved for at-home. I think the way you think about that is if there is a product that is has got a good safety profile, perhaps no risk of infusion-related reactions or no hypersensitivity reactions, there is a possibility those products could be given at home. Now, Hycuba is given at home by the patient themselves without supervision. Fesco actually needs to be given with a healthcare professional. So I think moving forward, you're onto something. I think we're definitely going to see more products being developed to be given at home. Argenix has actually talked about that with F-Cartigimod. And it will really depend on the safety profile, whether the patient is able to administer it themselves or perhaps with the aid of a healthcare professional, but in the home. And I think it's a trend we're seeing around the world where people want to move care to the least expensive setting. So we're very excited to be a part of that wave. And I think Enhanza is going to be a key enabler of that wave. For the conversion rate from IV to sub-Q, there's a number of factors that we've seen over the years with that. There's always a small proportion of patients who prefer and like the community of going into an infusion suite. And there's been data shown in that to show that's perhaps 5% to 10% of patients. Other than that, it can sometimes just be physician inertia. frankly, that sometimes can slow down the conversion from IV to sub-Q. But hopefully those are helpful, Anita, just as a couple of dynamics we've seen that can impact the rate at which and the ultimate amount of which IV goes to sub-Q.
spk01: Yes, that's helpful. Thank you. And just two more for me. Regarding the FASDO program, launch in the european region uh should we think about like the time for the logistics to set up to be about a month or possibly most of q1 and then we see the uptake of tesco
spk04: So we don't have any specifics on Fezgo, but I can say based on experience with European launches over the years in different companies, it actually can take between nine to 12 months for all of the major European markets to launch. And that's because each of them has a different process for the drug to get reimbursed. As an example, UK and Germany can happen quickly within the first quarter of following approval. But countries like France can sometimes take nine to 12 months because of their reimbursement process. So it is a bit more of a staggered launch pattern we expect to see in Europe, with a couple of the countries going early, but France, Spain being much more towards closer to the end of the year. But just a gradual rollout of countries all through the course of the year, with some of the large countries like France being in that 9- to 12-month period.
spk01: Okay, and thank you. And there's one more. Regarding, you know, acquisition of a complementary technology, would it likely be in the oncology, autoimmune neurology space to leverage existing relationships with current partners?
spk04: We're looking for a platform that we're going to be able to license to different companies. And because we're looking for a platform, it's a little early to say. Ideally, that platform would actually have utility across multiple different disease states and indications because it would be some form of technology that leading companies can add and integrate into their portfolios. And so we're certainly not setting out with any goal to restrict ourselves to work in oncology or autoimmune disease and neurology. Think of it more like enhanced, a technology that can be applied to all sorts of different drugs and disease areas because it brings a special enabling capability, but it hasn't got anything specific to do with a disease or a disease area.
spk01: Okay, that's helpful. Thank you. That'll be all for me. Thank you.
spk00: Your next question comes from the line of Joel Beauty from Citi. Your line is open.
spk06: Hello. My name is Ben from Palooch on for Joel. Quick question for us. It looks like greater than 20 targets of the 60 are still to be selected. I'm curious, is there a clock or a point at which a partner must select a target? And then how does this impact the deal terms if a target is not eventually selected?
spk04: Actually, in general terms, all of our contracts are a little different. But overall, there is a pretty long period of time for partners to select all of their targets within the agreement. And so we're actively working, as we mentioned in the prepared remarks, with each of our current partners to look at their portfolios and identify new targets to move forward into the clinics.
spk06: Great. Thank you. And then one last question. So this pertains to our genetics. So with our genetics moving forward with the bridging study, how important is that for a precedent for other enhanced programs? Thank you.
spk04: I would say all of our partners to date who have got commercialized products on the market, so we can look at it with Roche and with Janssen, have used a form of bridging. I think what is... different a little bit about the Argenix approach is they're using the pharmacodynamic endpoint whereas our previous partners have used a pharmacokinetic and an efficacy endpoint. And so it is setting up a precedent insofar as it is the reduction in IgG level which is a surrogate for the efficacy. So it is precedent setting from that standpoint. the bridging approach in and of itself is what all of our partners have done and frankly that's what allows this very rapid development time of four and a half to five years to approval is because they're using bridging but it's the first one to to be using a pharmacodynamic parameter
spk00: The last question comes from the line of Ben Shim from Canaccord Genuity. Your line is open.
spk02: Hi, everybody. Thanks for taking my question, and congratulations on the very strong results. Apologies if I've missed this. Can you give us a little more color on guidance for collaborative revenue in 2021? What are your assumptions for milestones, and what has been earned so far?
spk04: All right. I'll turn that one over to Elaine.
spk05: Sure. So we haven't provided further breakdown of the milestone payments, but what we have indicated is that we're anticipating a comparable level of milestones from collaborations as we had in 2020. And I would just note that our guidance excludes the potential for any new enhanced So it would exclude any potential upfront payments from a new enhanced partnership.
spk02: Okay. A couple more for you, Elaine. I think you previously communicated your intentions for the outstanding convertible note issue. Do you have any similar guidance for the 27 notes? And maybe can you remind us what the accounting treatment will be for EPS going forward?
spk04: Yes, Elaine, would you like to address that?
spk05: Sure. So I cannot speak to the proposed offering. I just refer you back to our press release. As you may have noted in our 10-K, we are expecting to early adopt ASU 2020-06 for convertible accounting. and which is associated with an ad back of non-cash interest expense. And you may recall that of the roughly $20 million of annual interest expense that we have on our P&L, about $12 million of that is non-cash. And I think that's what I can say there. And I think with respect to diluted shares, I think the diluted shares underlying our existing converts, I would say the analyst estimates on that I think have varied. That has probably resulted in a little bit of variance also in terms of consensus estimates on EPS. And I think what you can assume is that the dilutive nature of our existing converts is one of the things we're addressing with the proposed transactions. With that, I'd just say I'd have to refer any other specifics to the outstanding press release.
spk02: Thank you very much. That's very helpful, and congrats on the quarter. Thank you.
spk04: All right. Well, I see that we're at time. I just want to really thank everybody for your attention today. You've heard a story of Halazine, which was tremendous progress and performance in 2020, which has set us up for a similarly impactful 2021. So thanks very much for your attention, and we look forward to speaking next quarter. Thank you. Bye-bye.
spk00: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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