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spk06: Ladies and gentlemen, good afternoon. I'd like to welcome everyone to the Vera Vanspire Farmer third quarter 2021 conference call. During the presentation, all participants will be in a listen-only mode. A question and answer session will follow the company's formal remarks. To ask a question, press the star key followed by the digit 1 on your phone. Again, that's star 1 to ask a question. If listening via webcast, please mute audio on your webcast device before asking a question over the phone. I'll repeat these instructions after management completes the prepared remarks. Also, today's conference call is being recorded. And now I would like to turn the call over to Gail Cohen, Vice President, Corporate Communications. Please go ahead.
spk07: Good afternoon, and thank you for joining the Theravance Biopharma third quarter 2021 conference call to discuss our business. As always, I remind you that this call will contain forward looking statements that involve risks and uncertainties, including statements about our development pipeline, expected benefits of our products, anticipated timing of clinical trials, regulatory filings, and expected financial results. Information concerning factors that could cause results to differ materially from our forward looking statements is described further in our filings with the SEC. Now, I would direct your attention to slide three. Joining us are Rick Winningham, Chief Executive Officer, followed by Rhonda Farnham, Senior Vice President, Commercial and Medical Affairs, Rick Graham, Senior Vice President, Research and Development, and Andrew Heinemann, Chief Financial Officer. Now, I will hand the call to Rick Winningham for opening remarks.
spk11: Thanks, Gail. In mid-September, we announced the decision to restructure the company in order to optimize our business model. This decision followed a complete scenario planning exercise led by the board management with the assistance of outside advisors. Since the announcement, we've made a rapid transition to a streamlined, respiratory-focused TheraVance Biopharma. We immediately initiated a significant cost reduction program We've taken action to reduce the company's headcount by approximately 75%, estimated 270 positions, and we're on track to complete the large majority of these reductions by the end of this month, with the remainder to be completed in February of 2022. We're focused on leveraging expertise in developing and commercializing respiratory therapeutics and streamlined our future R&D investments to focus solely on the highest value respiratory assets. We'll continue to explore strategic partnerships for both core and non-core assets to unlock value. All of these actions drive towards our goal to maximize shareholder value. Moving to slide five, there are three key pillars of value creation for the go-forward plan, the build on our track record of respiratory innovation leading to several approved medicines for COPD and asthma. This includes Trilogy, or respiratory medicine, developed by Glaxo Group in collaboration with the company's predecessor, Theravance Inc., and Upelrate, which was discovered and developed by Theravance Biopharma, launched in 2019, and is now commercialized in the U.S. in partnership with Beatrice. Trilogy is experiencing exceptional growth with its dual indication for COPD and asthma, driving higher demand in the U.S., and GSK has obtained approval from for the asthma indication in 10 additional markets. Trilogy is currently expected to generate global peak sales of approximately $3 billion annually. Upelri remains early in its product lifecycle, has demonstrated market share growth quarter over quarter despite the respiratory pandemic. We believe it's got the potential to generate U.S. peak sales exceeding $400 billion. We believe the strong and growing cash flows of Trilogy and Upelri and the expected future robust revenue performance for both will generate significant value creation opportunities for our shareholders. It's my pleasure to have Rhonda Farnham, now SVP, Commercial and Medical Affairs, join us on the call today. Rhonda's been a part of the TheraVance leadership team since joining the company in July 2018 as Vice President Sales and Marketing, where she was responsible for the commercial execution of our branded products, including sales, marketing, and managed markets. Her deep commercial expertise and success has steered the team well. In her new role, with expanded responsibility, including medical affairs, I'm confident our progress will accelerate. Rhonda will provide an update on the strong and growing cash flows from UPowery and speak to the overall COPD market dynamic. COVID-19 continues to impact COPD patient visits, diagnoses, and new starts. Despite this dynamic, both UPelry and Trilogy, thanks to GSK's efforts, continue to grow market share and provide significant value to shareholders. Rick Graham will update you on where we are with the highest value core respiratory programs in the rest of the pipeline. Moving to slide six, as we stated in the announcement regarding our strategic actions, significant operating expense reductions to drive sustainable cash flow generation beginning in the second half of 2022, are critical, and we provided preliminary 2022 financial guidance. Andrew Heinemann will follow with the highlights of GSK's trilogy performance and an overview of our third quarter financials. I'll now turn the call over to Rhonda, who will share our commercial team's progress with you, Pelry, and speak to the COPD marketplace dynamics. Rhonda?
spk08: Thanks, Rick. I appreciate the opportunity to participate and provide this quarter's update. Turning to slide eight, upelry is the first and only once daily nebulized long-acting muscarinic antagonist that provides a full 24 hours of control for patients and is indicated for the maintenance treatment of patients with COPD. Despite the continued headwinds created as a result of the global pandemic, we are encouraged by the growth of upelry total prescriptions from Q2 to Q3. as well as the addition of new hospital accounts that are ordering each week. As a reminder, TheraVance Biopharma and Viatris co-promote in the United States with our combined sales infrastructure targeting healthcare professionals who treat COPD patients suitable for upelry. TheraVance Biopharma commercial and medical field teams cover the hospital segment of healthcare providers and Viatris covers community healthcare professionals. Also remember the Viatris TheraVans Biopharma commercial partnership is a 65-35 profit share split. Slide nine shows TheraVans Biopharma's implied 35% share of net sales for upelry during the third quarter 2021 of 13.8 million. Upelry year-over-year net sales are up by 7%. for Q3 2021 versus Q3 2020. The brand also continues to show quarter over quarter market share growth. Demand doses increased 1% in the third quarter over second quarter 2021 and 21% year over year. While institutions in some parts of the country are allowing more in-person access in-person engagements remain below pre-pandemic levels. Total prescription volumes continue to grow across most specialties with volumes heading towards parity with 2020. However, prescription volumes within the pulmonology specialty remain below pre-pandemic levels. Turning to slide 10, you can see that upel reshare continues to grow both in the hospital and the community retail settings. As we have noted previously, many patients with COPD experience an acute respiratory episode serious enough to require a trip to the hospital. The hospital becomes a key point to assess a person with COPD and convert or switch them from their current medication to upel reshare. Data shows that many patients who receive upelry in the hospital are discharged with a prescription to continue treatment, allowing for continuity of upelry therapy post-discharge. The Beatrice and Theravance Biopharma teams continue to work effectively and collaboratively using multiple tools and tactics and coordination to convert appropriate patients from competitive products to upelry during the hospital-to-outpatient transition experience. Over the course of Q3 2021, approximately 33% of all COPD targeted hospitals were physically accessible to our field colleagues, which was an actual decline from 62% the previous quarter. Despite the evolving institutional and outpatient clinic access, we have been encouraged with the growth in total prescriptions from Q2 to Q3. The new-to-brand prescriptions have remained stable over the same time period. In addition, new hospital purchasing accounts are being added weekly. Looking specifically at the TheraVans field sales deployment efforts in Q3 of 2021, doses sold exclusively in the hospital setting represented an 11.7% increase from the previous quarter. September upelry hospital volume hit a new launch-to-date high, and we saw a 43.5% year-over-year growth from September in 2020. Looking ahead, it is important to understand that according to the gold guidelines, a LAMA, or long-acting muscarinic antagonist, is foundational to COPD maintenance care. The execution of our tactical plan will continue to leverage these guidelines and appropriate patient types while we continue to optimize the marketing mix through rigorous and continued measurement of tactics. We will be initiating a phase four PIPFAR clinical study, which is aimed at helping to better inform decisions when physicians are designing a personalized COPD treatment plan with patients. This study will compare improvements in lung function in adults with two very severe COPD and suboptimal inspiratory flow rates following once-daily treatment with either epelri delivered via a standard jet nebulizer or teatropium delivered via a dry powder inhaler. Findings from this study are intended to provide data to support a possible label update and help to better inform physicians as they are working with their patients to design COPD maintenance treatment plans. And we expect the study to initiate later this year or early January 2022. Moving to slide 11, let's take a more macro look at the overall COPD retail market. If you take a rolling view over the past 12 months of both nebulizers and handhelds, Again, in the face of a respiratory pandemic, upelry and GSK's Trilogy demonstrate resilience to many of the external factors. As a reminder, Trilogy owned and marketed by GSK is the first and only once daily, single inhaler, triple combination therapy approved for the treatment of COPD and asthma. I'm not specifically highlighting Bradstreet's growth because of its recent launch timing, but let's take a closer look and move to slide 12. As a result of Bradstreet's entrance to the market and the addition of the asthma indication for Trilogy in September of 2020, the overall closed triple market has grown as expected and is also demonstrated on slide 13. GSK mentioned during their Q3 earnings last week that the dual indication is driving higher demand in the US. The slide also reconfirms the challenges pulmonologists experienced in the third quarter and throughout the pandemic when treating COPD patients, which include a decrease in in-person patient visit volume and a limited ability for healthcare professionals to diagnose and reassess their patients without pulmonary function test or spirometry. which cannot be performed via telemedicine visits. Both factors contributing to a reduction in prescriber confidence and fewer prescriptions. The pandemic also has led to increased insurance changes, which include Medicare patients migrating from fee-for-service Medicare to Medicare Advantage plans, which could result in higher patient co-pays and create and greater concerns of affordability associated with prescription fulfillment. We expect, as more people are vaccinated, boosters are given, and pulmonologists' ability to return to seeing more patients face-to-face in their offices grows, there will be a rise in sales for Trilogy and UPelry in the coming quarter in 2022. I'll now turn the call over to Rick Graham.
spk12: Thanks, Rhonda. The Go Forward organization is focused on the highest value core respiratory opportunities as outlined on slide 14. These include upelry life cycle management, including a clinical study in partnership with Beatrice. As Rhonda mentioned, success in the PIPR study would capture more of upelry's addressable market and further strengthen its competitive advantage. We'll be responsible for 35% of the cost of this study, which is planned to initiate in December 21 or January of 2022. Nezalcitinib is our most advanced clinical candidate, and we're finalizing the development program in acute lung injury, building on the efficacy and safety data, including the mortality benefit seen in the phase two study, which was reported in June. We're also looking to participate in externally funded platform studies, evaluating its potential role in treating hospitalized patients with severe lung inflammation. These studies could initiate in early 2022. We continue to see Nezalcitinib having potential application in chronic lung inflammation, including the prevention of lung transplant rejection and fibrotic diseases of the lung. Finally, our concentrated research effort aimed at developing a dry powder inhaled form of our inhaled PanJack inhibitor continues internally and we expect to proceed into the clinic with the next generation compound after securing a strategic partnership. Moving to slide 15. Our pipeline slide has been updated to reflect our respiratory focus and recent study results and decisions. Regarding the late stage non-core assets, the key operational activities for all isensitinib and amproloxacin studies will be completed by the end of the first quarter of 2022. The phase two study in Crohn's disease with isensitinib has completed enrollment with top-line results expected in the first quarter of 22. Top-line results from the ampryloxetine phase three study, Redwood, are also expected in the first quarter of 2022. And as a reminder, all patients in the Redwood study receive ampryloxetine treatment for 16 weeks, followed by a six-week randomized withdrawal period. We plan to share top-line results and present the data from these programs at future scientific forums. I'll now turn the call over to Andrew to review the financials.
spk10: Thanks, Rick. Let's first look at Trilogy. As Rhonda mentioned, Trilogy, owned and marketed by GSK, is the first and only once-daily, single inhaler, triple combination therapy approved for the treatment of COPD and asthma. Theravance Biopharma is entitled to receive upward-tiering royalties on global net sales of Trilogy. At present, 75% of the income from our economic interest is pledged to service principal and interest payments on our outstanding 2035 non-recourse notes. And the remaining 25% of income is retained by us. On slide 17, we capture the most recent information GSK shared during their earnings call on October 27th. They noted that Trilogy continued to lead the market as a single inhaler triple therapy with Q3 2021 sales growth of 77% over Q3 2020, generating global net sales of $449 million. And year-to-date in 2021, Theravance Biopharma has received $59.4 million from TRC LLC for our economic interest in Trilogy. Moving to Theravance Biopharma's consolidated financials, on slide 18, we provide our third quarter 2021 financial highlights. compared to the third quarter 2020. R&D expenses for the third quarter of 2021 were $43.7 million compared to $67.4 million in the third quarter of 2020. SG&A expenses for the third quarter were $21.3 million compared to $27.5 million in the third quarter of 2020. As a reminder, all of these figures exclude share-based compensation. and we ended the quarter with $216.2 million of cash and cash equivalents. Regarding financial guidance for the full year 2021, we are reiterating our previously issued guidance. For R&D, we expect to invest between $180 to $190 million relative to actual R&D investment of $230 million in 2020. For SG&A, We provided a range of $70 to $80 million relative to actual SG&A expense of $77 million in 2020. Again, all of these figures exclude share-based compensation. And during our announcement in September, we provided preliminary 2022 financial guidance. For R&D, we guided to investing between $55 to $65 million. And for SG&A, we provided a range of $30 to $40 million. We plan to update the 2022 financial guidance in January 2022. And with that, I'll turn the call back to Rick Winningham for closing remarks.
spk11: Thanks, Andrew. On slide 19, we summarize how we're creating a new respiratory-focused TheraVance Biopharma. First, it's about significant cost reduction to become sustainably cash flow positive beginning in the second half of 2022. We've already taken steps to significantly cut costs with a large majority of the approximately 75% reduction in force exiting by the end of this month and the remainder by the end of February 2022. Second, it's about value creation. As we reviewed, we have three significant levers. Growing upelry commercial performance. The TheraVance BioPharma and Vietris teams have done a great job serving the COPD community and gaining market share during the pandemic. We recognize the U.S. and global opportunity to increase profit on a brand basis once the pandemic further eases and pulmonologists return to seeing COPD patients in the office. Realizing the potential of nezalcetinib, the first inhaled JAK inhibitor targeted directly to the lung, this investigational compound has the potential and multiple indications for hyperinflammation of the lung over time and strategically designed clinical program to maximize return on investment. We'll build on our respiratory expertise when designing go-forward plan. And the third level of value creation we control is leveraging partnerships to unlock the value of core and non-core assets. Another key pillar of value creation is our economic interest in trilogy. GSK reported year-over-year sales growth of 77% this quarter for the same period in 2020. An estimated peak sales are approximately $3 billion. The new respiratory-focused TheraVance Biopharma is striving towards our goal to become sustainably cash flow positive beginning in the second half of 2022 and to maximize shareholder value. In closing, I'd like to thank our internal team for their perseverance through their tenure at the company, especially the last few months that have tested each of them personally and professionally. I'm grateful for their commitment to our mission of continuing to develop medicines that make a difference the progress of our clinical pipeline, UPELRI, as well as the communities we serve. I also want to thank once again the investigators, sites, patients, and the families across the globe who have been a part of our clinical trial programs. November is National COPD Awareness Month, and with early diagnosis and treatment, people with COPD can improve their quality of life and breathe better. I thank all the advocacy groups for their educational efforts. I'm hopeful that we can contain the pandemic and pulmonologists can start seeing patients with greater frequency face-to-face once again. I'll now hand the call back to the operator for questions.
spk06: Thank you, sir. Once again, if you would like to ask a question, you may do so by pressing the star key followed by the digit 1 on your touchstone telephone. If listening via webcast, please mute audio on your webcast device before asking a question over the phone. If you're using a speakerphone for today's call, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that's star one if you'd like to ask a question. And we'll pause for a moment to assemble our roster. We'll have our first question from Jeffrey Porges with SCV Lyric. Your line is open.
spk05: Thank you very much for taking a few questions, really mainly financial in nature. Rick, first, on the goal of sustainably break-even, Is that an aspiration, or is it your guidance that, given the trajectories that you see and the plan that you've laid out, that you will be sustainably breakeven in the second half? And then, secondly, could you give us some sense of the expenses that are associated with your current revenue from upelry? So, to TheraVans today, is upelry operationally breakeven, or what is the threshold for it becoming break-even. And then lastly, as you've considered all these strategic alternatives, do you see the company as having any assets that you could sell to generate value that you could reinvest in terms of pipeline or other complementary R&D opportunities? Thanks.
spk11: Thanks, Jeff. Our plan that we outlined, in fact, you know, is a plan that today we're planned to be sustainably cash flow positive after the in the second half of next year and beyond. So, you know, that's the that's the financial plan that that we put together for 2022 and beyond. And that's the plan that we're executing against you. Pelry as a as a brand is is, in fact, cash flow positive today. The financial dynamics of UPelry are quite attractive. That's one of the reasons that future sales growth is critical to continuing to grow those cash flow streams to both Theravance and Mylan. So UPelry is cash flow positive today, and we look forward to UPelry with sales growth becoming more cash flow positive in the future. Now, relative to the third question, which is asset sales, and I commented in my remarks that our approach is to partner both core and non-core assets as a way to manage the financial dynamics of the company. Obviously, we've got what we think are a terrific set of core assets in respiratory care. and then also exciting non-core assets that we've taken to a certain point in development and hold more promise, and we'll be working to optimize each of those financially as we move forward. So it may take the place of sale. It may take the place, in some instances, of partnership to generate cash flow coming back into the company. Andrew, do you want to come? Okay, Jeff, sorry. Go ahead.
spk05: Can I just follow up on that, though? In the case of Trilogy, it's really a fairly passive royalty. You don't have any direct role in the development or commercialization of that product. For example, over time, as Trilogy's revenue grows, then the amount that is paid to the bondholders as a proportion of the total will presumably come down, and the amount that comes back to to TheraBounce will go up. So have you thought about different strategic alternatives for that royalty, for example, since it's really your role in this is negative other than just being a dropbox?
spk11: Yeah, that's quite well described, our passive role. And the answer to the question is, yeah, we think about a host of different outcomes with Trilogy. We're Obviously, as Rhonda highlighted and Andrew highlighted, we're thrilled with the performance of Trilogy in the market, in particular the launch of the 200-microgram dose that's associated, the steroid that's associated with the treatment of asthma. And we'll look to maximize Trilogy's impact on the market value of Theravance Biopharma. Andrew, any other comments?
spk10: Yeah, nothing further to add, but then the concept that the business development, corporate development activities that are at the heart of your question, Jeff, take time to complete. So obviously, it's not prudent to give more specificity, but other than to tell you and the street that we are actively working across that spectrum, both from a, you know, partnering process perspective for the non-core and core assets, such as the JAK program, the pulmonary JAK program for asthma and COPD and pulmonary fibrosis, as well as looking at the financial assets, which Trilogy is effectively a financial asset, and you properly characterize the way that the royalties are paying off the debt for the 2035 non-recourse notes. And there's substantial cash flow that we believe that will come off of the future royalties that will accrue to Theravance Biopharma equity holders in due course.
spk05: Thank you.
spk06: Our next question comes from Mark Fram with Cohen and Company. Your line is open.
spk13: Thanks for taking my questions. Maybe just to follow up on some of the UPelry market dynamics that you went through, and thanks for all that level of detail. You pointed out the prescription volumes actually grew slightly in the quarter, despite the headwinds the whole market's facing. But but revenues actually declined a little bit. Is there some sort of stocking impact that we should be thinking about that was driving that, or did you have to take some sort of discounting actions to kind of maintain place as some of your competitors face generic entrants?
spk11: No, I think, well, you know, relative to, you know, relative to the financial dynamics of the net sales recognition, Mylan or Beatrice, you know, books the net sales. We've seen you know, we've seen fairly strong pricing and, you know, in certain markets, strong, you know, strong prescriptions. Others that were more affected by COVID, obviously, when I think this is the difference between the asthma and COPD markets, you know, you've seen pulmonology visits drop and the COPD rates prescribing, particularly when it involves changing a device or changing therapy. Pulmonologists like to see the patient in the office, and the lack of patient visits has had an impact on those COPD prescriptions. So we still see a reason for optimism just based on individual territory success in patients regions where COVID has receded already. But I'll let Rhonda sort of compliment and add to anything, any of my comments. Rhonda?
spk08: Yeah, thanks, Rick. And thanks for the question. And certainly building off of those external factors, you know, where we did see certainly some challenges in access, we still were able to obtain new formulary wins and grow the business, particularly in the hospital setting. So what is absolutely key to not only where we did see success in the past quarter, but certainly going forward, is to ensure we are maximizing in-person HCP access and the teams doing a great job already capitalizing on those opportunities and being mindful of the dynamics of where access is improving and where it's not, ensuring that we are executing on hybrid communication resources and tools and ensuring that that reach and frequency is also complemented by increased investments in our digital and media assets.
spk13: Okay, thanks. That's very helpful. And then maybe on the Phase 4 trial, comparing to Spiriva, I don't know if you can provide some details on just kind of the sizing of that trial, timelines, you know, in terms of when we might be able to see data and label updates.
spk11: Rick, you want to take that?
spk12: Yeah, sure, Mark. Like Rhonda said, we're getting close to being able to kick that study off. Probably the best thing to do is to think back to what we've reported previously on the first paper study. We actually took the learnings from that and designed the second study here. We can say at this point it's several hundred patients. It will include revifenicin and teatropium, as Rhonda mentioned. Timing, will start either December or January. And then, you know, we do expect that that will probably take around a year to enroll.
spk13: Okay, thanks. Very helpful.
spk06: Our next question comes from Lisa Baco with Evercore ISI. Your line is open.
spk01: I think you just answered my question with your last response. But I guess maybe can you also characterize like how much you know, bigger you think the market could be with a PIP or study under your belt? Thanks.
spk11: Yeah, I think, you know, we've traditionally looked at patients with low peak inspiratory flow and estimates of patients with low peak inspiratory flow representing 15 to 20% of COPD patients. Today, Patients who use nebulized therapy for maintenance represent about 9% to 10% of all COPD patients. So I think we'd see a pretty significant increase in market opportunity. Obviously, teatropium is the market leader in single-agent long-acting muscarinic antagonists, and I think this is one of the things that excites us is that patients Revifetacin provides very solid FEV1. You just have to look at our label to see those FEV1 improvements over placebo and the opportunity to really refine, as Rick said, the low PIPR population that responds the best to nebulized Revifetacin is a terrific opportunity to get to market growth. Rhonda, anything to add there? might've lost Rhonda temporarily. So Lisa, anything else? Oh, there we go.
spk06: That's it for me. Oh.
spk08: I'm back. I'm back.
spk11: Okay. So anything to add on market opportunity?
spk08: Sure. I lost you a bit, but I think I can pick up on some additional commentary there. If you think about this phase four study and how it can aid the COPD clinician to understand which patients could best benefit, so thinking about those one in five patients who have low PIFR, so which could benefit most from nebulized therapy, and then assuming a positive outcome of this study that provides us a new data opportunity, a new data communication, an educational opportunity for which our team could thereby offer to exhibit an increasing competitive advantage and add value to our overall promotional efforts. Okay, thanks.
spk06: Our next question comes from Douglas South with HC Wainwright. Your line is open.
spk00: Hi, good afternoon. Thanks for taking the questions. Just, Rick, maybe it'd be helpful to understand as you sort of restructure your company how you're thinking about resources between the existing portfolio molecules versus, you know, some of the work in terms of identifying new molecules. which is obviously, if you think about the company's success over the years, has been identifying sort of lung-specific and organ-specific targeted therapies.
spk11: Yeah, that's a great question. I think what most of our dollars, as we look forward, are in development. I think we're going to capitalize on the research work that's done historically and a small commitment of ongoing research, but I think one of the strengths of the company is that we do have a portfolio of compounds that are near the clinic that can be leveraged in development. I'll kick it over to Rick Graham.
spk12: Yeah, not much to add other than right now with this reorganization that we just announced six weeks ago, where we have a team of people that we've retained that are laser-focused on continuing development of nezalcitinib in a streamlined way, as well as continuing to work through the dry powder inhaled jack inhibitor. And remember, we're still in the process of closing down these late-stage studies. We had, you know, hundreds of sites for isancitinib and ampryloxetine around the world. So that's going to be our focus for the short-term, Doug. Okay.
spk00: Thank you.
spk06: Our next one question comes from with Morgan Stanley. Your line is open.
spk04: Great. Thanks for taking the question. Going back to you, Pelri, I was wondering if duration of therapy is a metric that you track and have commented on. And if so, I was wondering if you could give us any color on how that's trended since the product's launched and through the past couple of months through the pandemic.
spk11: Yeah, I think probably the only comments that we've made on duration of therapy overall is that we, another aspect of the importance of the hospital as a point of treatment initiation is that we do see longer levels of persistence with patients who are switched to medicine in the hospital. I would underscore something I think both Rhonda and I mentioned, which is we still consider ourselves you know, relatively early in the launch of UPelri because of the impact of the pandemic, you know, hitting in really February, March period, February 2020. But Rhonda, anything else?
spk08: It's certainly a metric we attempt to closely track. However, I'll just comment, it's quite difficult to assemble and recognize that those data lag from patient claims to be able to piece that together. But to answer your question specifically, have we seen a decline during the pandemic? We have not. The duration has been reasonably stable to what we were seeing in early 2020. Got it.
spk04: That's helpful. Thank you. And then a follow-up question on a separate topic. On your agreement with Innoviva and TRC on the trilogy royalties, Could you just update us on where any dispute with Innoviva currently stands and if there's been any updates on your discussions with Innoviva over the past couple of months?
spk11: Yeah, there's, I mean, we received another $13-plus million out of TRC in early October. I think we have a total of around $59 million we've received out of TRC in October. In 2021, that's the partnership that's managed by InnoViva. We're not in a dispute currently with InnoViva. We continue to work with InnoViva on TRC and work to protect our rights under the agreement and the arbitration rulings that have been held. As I've said before, the The nature of the rulings create a degree of lumpiness in the cash flow coming out of TRC, but at the end of the day, we receive 85% of the economics out of TRC, and Aviva receives 15%, and that's unchanged. Andrew, anything else to comment on that?
spk10: Well, nothing really further to add, although investors will notice that there are changes on our balance sheet for September 30, 2021, that do reflect the totality of the receivables that we are due. And we keep track of every penny of the 85% that Rick just mentioned.
spk04: Okay. Understood. Thank you.
spk06: Our next question comes from Brian Scorny with R.W. Baird. Your line is open.
spk09: Hey, this is Luke Herman on for Brian. We were just wondering, for nezalcinib, could you talk about the market's clinical plan and timelines in acute lung injury and fibrotic disease? And then secondly, was there any more color you could provide on the dry powder jacks and any preclinical color that makes you optimistic?
spk11: But yeah, I'll get started on it. I think it's not only the preclinical work that makes us optimistic, but it's the clinical work that makes us optimistic. I mean, you know, this is a JAK inhibitor. If you're talking about the nebulized JAK, it penetrates into the lung. You know, it is a pan JAK inhibitor. It does reduce inflammation in the lung and the The affecting the JAK-STAT pathway obviously has been reducing, inhibiting that's been implicated in reduction in fibrosis in a number of different models, animal models. So, you know, that's where we're encouraged. I think we see two different segments. One of them is a nebulized, clearly nebulized JAK inhibitor, which is Nezuncetinib. And the second is the dry powder inhaled JAK program, which does require a different chemical design to facilitate delivery through a dry powder inhaler. We've seen anti-inflammatory effect with the lead there. We thought the lead, which was 8236, it could be improved on. And so I think we're just really at the – not so much at the very beginning, but in the early stages of leveraging the JAK-STAT pathway to address hyperinflammation of the lung. Rick, maybe you want to touch a little bit more on the chronic indications?
spk12: Sure, sure, just a little bit. I think, you know, there are a lot of opportunities here, as Rick pointed out, parnevilsitinib. And just stepping back for a minute, it's worth reminding everybody that we released results from 200 patients phase two study in COVID-19 with nezalcitinib back in June. Our team subsequently engaged with global health authorities, and then we've been in discussions around various externally funded platform studies. So there's been a lot of work going on with nezalcitinib. We do think that that work in COVID is going to be applicable to future indications, both acute and potentially chronic indications. So as Rick talked about, you know, we're now focused on a streamlined R&D organization, and with nezalcitinib as our most advanced asset, we're looking forward to providing updates in the near future. With regard to chronic indications, you know, we did talk about fibrotic disease, and just keep in mind that fibrosis is a feature of most chronic inflammatory diseases, can affect pretty much every tissue in the body, including the lung. And when it's progressive, Fibrosis can lead to organ malfunction and ultimately death. And importantly, the JAK-STAT pathway is known to be involved in the development of fibrotic disorders. So like Rick said, lots of opportunities here, and we're taking a measured approach to figure this out. Great.
spk09: Thanks so much.
spk06: Our next question comes from Joseph Stringer with Needham & Company. Your line is open.
spk03: Hi, everyone. Thanks for taking our questions. Two from us on upelry. Just curious, given that you're co-promoting the drug in various settings, wondering if your guidance, your 2022 guidance sort of reflects or gives you flexibility to sort of potentially increase investment there or increase capital in that direction to potentially you know, continue to drive sales, whether it be expansion of sales force or something like that. And then secondly, more on, and sorry if I missed this earlier, but in the past you've given some metrics around HTTP interactions and in-person interactions. Just curious if those were up, you know, 3Q relative to 2Q. Thank you.
spk11: Rhonda, you want to take the in-person interactions because you covered part of that.
spk08: Yeah. Looking at Q3 versus Q2, they were down slightly for in-person engagement, but overall engagement, considering the team does still promote virtually on par there, but the in-person are what we see as the most important and greater impact.
spk11: Yeah, relative to UPEL reinvestment in our current plan, we have, you know, and I would say that our, you know, as Andrew highlighted, we'll provide more guidance in January with regard to the spending in 2022, but under the current plan, We've got – between Mylan and – or Beatrice and Theravance Biopharma, we've got increased investments in our plan for UPelry because we do think it's a significant opportunity for the partnership.
spk08: Great. Thanks for taking our questions.
spk06: Our next question comes from Anupam Rama with J.P. Morgan. Your line is open.
spk02: Hey, guys, just a really quick one for me. Can you remind us of the sales cutoff for the tiering of the royalties on the global sales of Trilogy for that 5.5% to 8.5%? Thanks so much.
spk11: I'll tell you, I don't have that. We're in another tier right now. I don't have that handy. That is publicly available on the SEC website. I don't know, Andrew, do you have
spk10: The first tier is 750 million global net sales, and then it goes upwards from there to the second tier. Off the top of my head, I believe it's 1.25 billion, and then 1.75 billion, and then above. But we can double-check that. I'm sure I'm correct off the top of my head and loop back with the schedule that's pulled from the actual document.
spk11: Yeah, so here you go, Anupam. Up to $750 million in global sales. The royalty rate is 6.5%. From $750 to $1.25 billion, it's 8%. Up from $1.25 to $2.25, it's 9%. And above $2.25, it's 10%. Now, that is the gross royalty rate. And then 85%. uh, as the implied royalty of that number. Those numbers are implied royalty rate back to Theravance Biopharma.
spk12: Thanks so much. Yep.
spk06: Thank you. It appears we have no further questions on the phone. And now if you turn the conference call back over to Mr. Winningham, please go ahead, sir.
spk11: Yeah. Thank you for joining us today for today's quarterly call. We look forward to, uh, sharing the progress with you in the future of the new streamlined TheraVance Biopharma. Have a great day.
spk06: This concludes today's conference call. We thank you for your participation. You may now disconnect.
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