Theravance Biopharma Inc (TBPH) 2016 Q2 法說會逐字稿

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  • Operator

  • Ladies and gentlemen, good afternoon. At this time I would like to welcome everyone to the Theravance Biopharma 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. (Operator instructions)

  • Today's conference call is being recorded, and now I'd like to turn the call over to Renee Gala, Chief Financial Officer. Please go ahead.

  • Renee Gala - CFO, SVP

  • Good afternoon, everyone, and thank you for joining our second quarter 2016 financial results conference call and webcast. With me on the call today are Rick Winningham, our Chief Executive Officer, and Brett Haumann, Senior Vice President Clinical Development, and Chief Medical Officer, who will provide an update on our priority programs and review anticipated upcoming key clinical and regulatory milestones. I will discuss our financial results for the quarter, and then we will open up the call for questions.

  • A copy of the press release can be downloaded from our website, or you can call investor relations at 650-808-4045 and we'll be happy to assist you.

  • We would like to remind you that this conference call contains forward-looking statements regarding future events and the future performance of Theravance Biopharma. Forward-looking statements include anticipated results and other statements regarding the company's goals, expectations, strategies and beliefs. These statements are based upon the information available to the company today, and Theravance Biopharma assumes no obligation to update these statements as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's Form 10-K and other filings with the Securities and Exchange Commission.

  • And now I'd like to hand the call over to Rick Winningham. Rick?

  • Rick Winningham - Chairman, CEO

  • Thanks, Renee. Good afternoon, everyone, and thank you for joining us. As we anticipated, 2016 is unfolding as a pivotal year in Theravance Biopharma's growth and development. We're delivering on our goals and milestones, our priority programs are advancing as planned, and our performance is on track for the year.

  • We reported positive Phase I results for TD-1473, our oral GI targeted pan-JAK inhibitor, showing favorable safety and tolerability of single and multiple ascending oral doses, and achieving our target pharmacokinetic profile. We look forward to the important milestone of initiating a Phase 1b in patients with active ulcerative colitis later this year.

  • We reported positive results, including evidence of target engagement and low renal clearance, for a single ascending dose study of our next generation NEP inhibitor, TD-714, and expect to complete the multiple ascending dose study later this year. These data advance our efforts to develop a potential best in class therapeutic with a differentiating feature of non-renal clearance for cardiovascular and renal diseases.

  • We completed enrollment in three large Phase III studies of revefenacin in COPD, enrolling a total of more than 2,300 patients in approximately eight months. The replicate efficacy studies are expected to read out in the early fourth quarter of this year to be followed by the long-term safety study readout and planned NDA filing in 2017.

  • We continue to make good progress implementing our commercial and label expansion strategies for VIBATIV as evidenced by our strong second quarter sales. We have a growing pipeline of partnered assets which, along with our economic interests in certain respiratory programs being developed by GSK and Innoviva, represent valuable near and midterm opportunities for our company. Last month, GSK and Innoviva announced positive topline results from the pivotal Phase III FULFIL study of the Closed Triple and COPD patients in addition to the acceleration of the US regulatory filing from 2018 to 2016.

  • With our strong cash position, maturing product portfolio and full slate of upcoming milestones, we're building a strong foundation to develop differentiated therapies for patients with serious illnesses and to create value for shareholders.

  • From our mid-year vantage point and looking ahead to the second half of 2016 and beyond, we believe we're delivering an impressive lineup of accomplishments, including key clinical and regulatory milestones, are continuing to build significant long-term value in our company.

  • I'd now like to turn the call over to Brett who will provide some additional color on our priority programs.

  • Brett Haumann - SVP Clinical Development, CMO

  • Thanks, Rick. I'll start with TD-1473, our oral pan-JAK inhibitor specifically designed for targeted delivery to the gastrointestinal tract for the treatment of inflammatory bowel diseases, including ulcerative colitis, a debilitating disease of the lining of the colon that affects roughly 700,000 patients in the US each year.

  • Our goal is to develop a treatment option for UC, and other GI diseases, with a highly favorable therapeutic index, and a clinically meaningful benefit that is differentiated from currently approved and investigational therapies. These include injectable biologicals, such as anti-TNF and integrin inhibitors, as well as oral medications, such as tofacitinib an oral JAK inhibitor. These systemically active therapies have shown varying degrees of efficacy in UC, but carry the risk of systemic immune suppression, which can lead to serious side effects, including infections and tumors that limit their long-term use in patients.

  • Our vision for 1473 was to create a drug candidate that could represent a radical change in approach to the treatment of inflammatory bowel disease, such as UC, not just an incremental improvement over current approaches. 1473 was purposefully designed for targeted delivery to the colonic mucosa where it can act to reduce disease activity at the relevant site of inflammation without being released into the systemic circulation to any significant degree. This targeted approach is one we've employed for many years in the development of inhaled medications for the treatment of diseases of the lung.

  • We designed 1473 to be an orally available small molecule that has an optimized solubility and permeability profile to ensure slow and limited absorption throughout the full length of the intestine. In addition, it has the right dynamics and kinetics to block the immune response at the site of inflammation in the colon with very little systemic exposure so that the risk of systemic side effects is minimized.

  • In June, we hosted a key opinion leader event for the investment community based on the current standard of care for UC and GI diseases, JAK inhibitors as a class, and 1473's differentiated product profile and potential utility as a targeted local therapeutic option. Preclinical in vitro and ex vivo data showed that 1473 is present in the colon, including in the inflamed colonic wall, and is having anti-inflammatory effects in the cells of interest. Our in vivo preclinical models have demonstrated that 1473 reduces disease activity to a level that is at least as good as tofacitinib, but without the associated immunosuppression.

  • At this event, we reported results from our recently completed Phase I program showing that 1473 met our target PK profile with favorable safety and tolerability to support progression of 1473 to a Phase Ib trial in patients with UC. The totality of the data generated in the program to date validate our strategy of targeting JAK inhibition in the affected tissues within the intestinal tract in order to achieve desired therapeutic results, while at the same time minimizing the risk of systemic effects, such as immunosuppression. We believe that 1473 represents a potential breakthrough approach to treating ulcerative colitis, including the potential to be used in patients earlier in the course of their disease, ahead of injectable biological agents.

  • Later this year, we plan to initiate our Phase Ib dose ranging trial, which will be the first time 1473 will be administered to ulcerative colitis patients. This study should yield important additional safety and disease activity data, and we're excited to embark upon this important milestone in our efforts to develop a treatment for ulcerative colitis and other inflammatory bowel diseases.

  • I'd now like to turn to discuss our NEP inhibitor program where our goal is to develop a medicine that has broad potential to be combined with complementary mechanisms to treat chronic heart failure and other serious cardiac and renal diseases. TD-0714 is the most advanced compound in our NEP inhibitor program. Last quarter, we reported favorable safety, PK and biomarker data from the Phase I single ascending dose study of 714 in healthy volunteers. This study met our target product profile of sustained 24-hour target engagement, based on elevated cyclic GMP, favorable safety and tolerability, and non-renal clearance.

  • The finding of non-renal clearance is especially important because a significant number of patients with cardiac and renal disease who may benefit from NEP inhibition, also have compromised renal function. And drugs that are renally cleared, such as the NEP inhibitor in Entresto, have the potential to accumulate, increasing the risk of unwanted side effects and/or requiring dose adjustment.

  • Our Phase I multiple ascending dose study of 714 in healthy volunteers is ongoing, and is scheduled to read out in the second half of this year. We believe that our NEP inhibitor program has the potential for broad applicability beyond chronic heart failure. It has the potential to be combined with a range of other mechanisms and may offer advantages over Entresto, including once daily dosing via oral or intravenous routes, sustained 24-hour target engagement, and importantly, non-renal clearance. Achieving non-renal clearance may enable our NEP inhibitor to treat chronic heart failure in a broad range of renally compromised patients without dose adjustment, as well as in patients with acute heart failure and chronic kidney disease, including diabetic nephropathy. A product with this target profile could represent a major advance in treating these diseases.

  • Now, turning to our late-stage pipeline. The Phase III program for revefenacin, our investigational, nebulized, once-daily, long-acting muscarinic antagonist, or LAMA, for the treatment of COPD, has progressed rapidly. We completed enrollment across all three pivotal Phase III studies, successfully enrolling more than 2,300 patients in just over 200 US clinical sites over an eight month period. The next key milestone will be the readout from our replicate Phase III efficacy study anticipated early in the fourth quarter of 2016. This will be followed by readout of the 12 month safety study slated for completion in 2017. Assuming positive outcome from all three studies, we plan to file an NDA for revefenacin next year.

  • We and our partner Mylan are also working together in earnest on the detailed commercial planning for revefenacin. We believe that there's a large commercial opportunity for revefenacin as the first once daily nebulized bronchodilator for COPD. There's an opportunity to become a standard of care in this market segment.

  • Patients who require or prefer nebulized therapy, because they may not be able to receive adequate bronchodilation with a handheld device, do not currently have any once daily therapeutic options. We believe this COPD patient population is large and underserved, encompassing the 9% of COPD patients who use nebulizers for ongoing maintenance therapy, and the approximately 41% of COPD patients who use nebulizers intermittently for bronchodilator therapy.

  • We're especially interested and excited by the prospect of co-promoting revefenacin with Mylan as it aligns well with our commercial focus, capabilities and expertise in the acute care market segment where our sales reps are experienced in calling on pulmonologists and respiratory care physicians for VIBATIV.

  • There are about 800,000 patients admitted each year to US hospitals for worsening of their COPD. About half of these patients leave the hospital with a prescription for nebulized therapy. This is important because having an established commercial presence in and around acute care centers gives us the opportunity to target large and addressable patient populations at pivotal times, starting in the hospital and expanding into the outpatient treatment setting.

  • Now, I'd like to turn the call back to Rick.

  • Rick Winningham - Chairman, CEO

  • Thanks, Brett. Turning to VIBATIV, we continue to make good progress in implementing our commercial strategy. Net sales were strong in the second quarter, approximately 62% higher than the prior quarter. We're pleased to see that we're gaining traction in all target acute care settings, including the hospital and outpatient settings, and infusion centers, which can serve as an important site of care post-discharge.

  • Label expansion remains a key strategy for VIBATIV with a goal of optimizing the product's commercial potential. Our 250 patient Phase III registrational study in primary bacteremia is ongoing, and expected to complete in 2018. If successful, we would have the only branded antibiotic with approval for complicated skin and skin structure infections, hospital acquired ventilator associated pneumonia and bacteremia, three difficult to treat infections. This broad label could represent a key competitive advantage for VIBATIV as these infections can present at the same time.

  • Furthermore, as we noted last quarter, the VIBATIV label now includes data describing the treatment of patients with concurrent bacteremia in both complicated skin and skin structure infections, as well as HABP/VABP. Finally, our TOUR registry program, which has enrolled approximately 350 patients to date, is progressing well and generating useful data on additional potential indications for VIBATIV. We look forward to sharing those data at scientific and medical conferences later this year.

  • This broad and growing collection of data supports our position that VIBATIV is a key therapeutic option for patients in the indications for which it is approved, in particular when vancomycin and other therapies are not suitable. VIBATIV is a valuable asset for our company and is the cornerstone of our acute care business strategy. We look forward to continuing to expand its utilization in the marketplace.

  • Now I'd like to turn the call over to Renee to provide a financial update.

  • Renee Gala - CFO, SVP

  • Thank you, Rick. Revenue for the second quarter of 2016 was $5.5 million, primarily due to US net product sales of VIBATIV of $5.4 million. This amount represents a $3.3 million increase in US net product sales compared to the same period in 2015. The increase in sales is principally due to the expansion of our VIBATIV sales infrastructure, which was complete by the beginning of the fourth quarter of 2015.

  • As a reminder, our second quarter revenue excludes the $15 million upfront payment from Takeda Pharmaceuticals associated with the TD-8954 license agreement announced in the second quarter. This transaction received HSR clearance in the third quarter, thus we expect to recognize and receive a $15 million payment from Takeda in Q3.

  • Research and development expenses for the second quarter of 2016 were $32.1 million, representing an increase of $1.7 million compared to the same period in 2015. The increase was primarily attributed to costs associated with the progression of our priority programs. Total R&D expenses for the quarter included $5 million in non-cash, share-based compensation expense.

  • Selling, general and administrative expenses for the second quarter of 2016 were $20.3 million, representing a decrease of $1.3 million compared to the same period in 2015. The decrease is largely driven by lower costs associated with share-based compensation expense. SG&A expense for the quarter included $4.9 million in non-cash share-based compensation expense.

  • Cash, cash equivalence and marketable securities as of June 30th, 2016 totaled $302 million. The quarter end cash balance excludes both $35.1 million in receivables from collaborative arrangements, largely related to our Mylan collaboration, and the $15 million licensing payment from Takeda.

  • Our financial guidance for 2016 remains unchanged from the guidance communicated in the last quarterly call. In 2016 we expect to incur a full year operating loss, excluding share-based compensation, in the range of $120 million to $130 million. With a cash balance of just over $300 million, including proceeds from our recent public offering, we are well capitalized going into the second half of 2016.

  • Now I'd like to turn the call back over to Rick.

  • Rick Winningham - Chairman, CEO

  • Thanks, Renee. I began my comments by saying that 2016 is unfolding as a pivotal year for Theravance Biopharma. We believe that our priority programs represent valuable and differentiated product opportunities with the potential to have a meaningful impact on patients' lives and change how serious diseases are treated. These programs are expected to generate potentially transformative milestones over the next 6 to 18 months, strengthening our ability to generate value for patients and shareholders.

  • Our pipeline of priority programs is augmented by a portfolio of partnered or partnerable assets with meaningful financial importance to our company, including: TD-8954, which was recently licensed by Takeda and is advancing in enteral feeding intolerance, or EFI; TD-9855, which has shown promise in fibromyalgia, for which we are exploring utility in neurogenic orthostatic hypotension, or NOH; Velusetrag in a Phase IIb study for gastroparesis, which is largely funded by our partner Alfa Wassermann, and for which we retain full rights in the United States; and our economic interest in certain respiratory assets being developed by GSK and Innoviva, including the Closed Triple.

  • Should the Closed Triple be successfully developed and commercialized, we are entitled to receive 85% of the royalties ranging from 6.5% to 10% on GSK's worldwide net sales. Additionally, GSK is responsible for all development costs related to the Closed Triple, with no costs being borne by Theravance Biopharma. If approved, the Closed Triple could provide a meaningful revenue stream for our company. In discussing the market opportunity for the Closed Triple, GSK noted in their second quarter call that roughly one-third of COPD patients are already utilizing Open Triple therapy. Given the progressive nature of COPD, patients will need access over time to more effective therapies.

  • In May, GSK reported the results from the Salford lung study, a groundbreaking Phase III real world effectiveness trial in COPD exacerbations, which were strongly supportive of the benefits of once daily therapy. Taken together, these indicators point to a significant market potential for a first in class, once daily Closed Triple, especially if GSK is successful in establishing a Closed Triple, as they intend, as the triple of choice.

  • The richness of our overall pipeline, including programs that we are advancing internally and those that we have licensed externally, is a testament to the value of having a robust R&D engine. This engine enables us to prioritize programs and how we invest in them versus how we leverage partners to ensure the optimal level of resource allocation and to identify the right indication, the right development commercial strategies, and the right way to create the most value for patients and shareholders.

  • Looking ahead, the key clinical and regulatory milestones that we expect to drive value in the company are as follows. Completion of our Phase I MAD study for 714 in 2016. Completion of the two Phase III efficacy studies for revefenacin in 2016. Completion of a long-term safety study for revefenacin in 2017 with a planned NDA filing before the end of 2017. Completion of our Phase 1B trial for 1473 in UC patients in 2017. Expected EU and US regulatory filings for the Closed Triple by GSK in 2016. Completion of the Phase IIb study of Velusetrag in gastroparesis in 2017. And completion of the Phase III registrational study of VIBATIV in bacteremia in 2018.

  • In summary we believe we have a great company with products that can improve outcomes for patients and that represents a unique and compelling opportunity for shareholders.

  • Now I'd like to turn the call over to the operator for questions.

  • Operator

  • Thank you, sir. (Operator instructions) We'll have our first question from Geoffrey Porges.

  • Geoffrey Porges - Analyst

  • Hi, this is Geoff Porges. Hi, Rick. How are you? Congratulations on the quarter.

  • Rick Winningham - Chairman, CEO

  • Thank you, Geoff.

  • Geoffrey Porges - Analyst

  • A couple of questions, if I may. First on VIBATIV, a nice trend there. Could you give us a little color about whether there are any one-time items that contributed, and whether this trend looks to be sustainable? Do you think that there's additional mileage you can get out of the sales force? And then on the JAK inhibitor, could you talk a little bit more about what you take away from the recent XELJANZ disclosure on UC? How does that impact your thoughts about the prospects of 1473? Thanks.

  • Rick Winningham - Chairman, CEO

  • Great. So I'll address the VIBATIV question and then both Brett and I will address the XELJANZ question. So, you know, I think we're seeing a nice trend with VIBATIV sales in the market. We're clearly expanding the number of accounts that are ordering VIBATIV. What we have seen since we began the introduction of VIBATIV is once a physician uses VIBATIV in a difficult to treat patient, they use it again. And this is played out in territory after territory, physician after physician.

  • So I think that we actually are just beginning to get the mileage out of the sales force. We had 50 represents onboard at the beginning of the fourth quarter last year. And now we're sort of nine months -- we're nine months into that with people in the appropriate territories, appropriate calls being made, et cetera. And of course this is an institutionally based product, so it's not as if one call results in one sale, but multiple calls need to be made and formularies have to be -- we have to have formulary successes, and the outpatient market is very successful.

  • So, I would say we're very encouraged by the VIBATIV growth to date. We believe that there's significant additional mileage that we can get out of the sales force, and a bright future for the product.

  • And I would just close out on the VIBATIV sales force in the acute care organization. We do believe that the acute care organization that we have will be very important to the success of revefenacin when we get to the point of launching that product.

  • Now on XELJANZ, and XELJANZ is a JAK inhibitor being developed by Pfizer for ulcerative colitis, already approved for RA. And XELJANZ is a more typical I would say approach to the treatment, which is an orally absorbed product that is delivered into disease tissue through the circulatory system. Clearly it looks as if the Phase III program has been a success, but we do believe that we're developing 1473 in a manner that can be substantially differentiated from XELJANZ, as well as any other oral or injectable medicine. And I'd like Brett to expand on that.

  • Brett Haumann - SVP Clinical Development, CMO

  • Thanks, Rick. Certainly to add to that, I think on the one hand we like the fact that XELJANZ, or tofacitinib as it's known, discharges a proof of principle or a proof of mechanism in establishing that JAK inhibition does work in ulcerative colitis. Unfortunately though, tofacitinib wasn't designed to treat ulcerative colitis by first intent. Its primary focus was initially on organ transplantation and then more latterly in rheumatoid arthritis. And so their design principles were to get as much of the drug into the systemic circulation as possible. And in doing so, treat rheumatoid arthritis.

  • Unfortunately that brings some systemic liabilities, particularly immunosuppression, which leads to an increased risk of both opportunistic infections and reduces tumor surveillance, increasing the risk of opportunistic tumors as well. So if you were going to design a product that exploited the benefits of JAK inhibition but targeted just the colonic mucosa, you would take the approach we have rather than a systemic one.

  • We've been able to limit the exposure and the penetration of our JAK inhibitor, exploiting all of the therapeutic benefits but not getting the systemic effects that may limit the opportunity with tofa. In fact if you look at the Phase II data of tofacitinib, there was greater efficacy seen even with the 15 milligram dose than with 10, but 10 was carried forward into their Phase III program. And we think that's probably at least in part due to the fact that the 15 milligram dose, although more efficacious, carried a greater degree of risk.

  • Now if we're able to limit our exposure, we may well be able to exploit this opportunity and see even greater efficacy with tofa -- sorry, with 1473 than we've historically seen with tofa and with a much more benign safety profile as well.

  • Geoffrey Porges - Analyst

  • Sorry, Brett, can I just follow up and ask you. Could you remind us of the spectrum of JAK kinase inhibition for tofa compared to 1473?

  • Brett Haumann - SVP Clinical Development, CMO

  • Sure, great question, Geoff. Although the XELJANZ product, or tofacitinib, described as a pan-JAK inhibitor, its potency is predominately against JAK 1 and 3. In contrast, our product, 1473, has true pan-JAK inhibition, and demonstrates a much higher degree of potency, particularly for [TIC2] than tofacitinib does. That may have relevance in considering the potential utility of 1473 beyond ulcerative colitis. In Crohn's disease, TIC2 may have a more important function. And if we look at products like Stelara, which inhibits both IL-12 and 23, they play on TIC2 and have demonstrated utility in Crohn's. So we may actually be able to see benefits with 1473 that exploit that potential benefits, whereas tofacitinib has not been able to demonstrate as great an efficacy in Crohn's disease as they have in UC.

  • Geoffrey Porges - Analyst

  • Great. Thanks very much.

  • Operator

  • Thank you. Our next question comes from Louise Chen of Guggenheim. Your question, please?

  • Rick Winningham - Chairman, CEO

  • Louise, are you there?

  • Unidentified Participant

  • Hi. Sorry, we were on mute. Hi, this is [Vena] on for Louise. Thanks for taking the questions, and congratulations on the quarter. Could you give us some more color on your partnership with Mylan for revefenacin, specifically the commercial planning that you mentioned earlier on the call? And then also just generally your thoughts on the market opportunity and your economics for that product. And then secondly, how should we think about the $200 million or $400 million peak sales potential for VIBATIV? And what do you think differentiates VIBATIV from its competitors? Thank you.

  • Rick Winningham - Chairman, CEO

  • Sure, so I'll take the VIBATIV question first, and then turn it over to Renee and Brett for Mylan. Well VIBATIV, the differentiating features for VIBATIV biologically are its dual mechanism of action against cell wall and cell membrane of staph aureus, and in particular MRSA, leading to a very potent product that's bactericidal, and has terrific tissue penetration, so it works in difficult to treat infections.

  • The label is certainly, in terms of the indication, is a benefit, having complicated skin as well, as well as HABP/VABP, and now having added to that the cases of concurrent bacteremia that were found in both the skin and the HABP/VABP clinical studies. So I think while those provide a nice opportunity, clearly the bacteremia Phase III, registrational Phase III study would round this out quite nicely in having a product that could be used in a series of infections that clinicians in the United States, and in fact all around the world face, that are in many instances lethal to the patient, or in fact cause risk of loss of an extremity. So I think, you know the core biological characteristics of VIBATIV are what provide its advantage and deliver on its efficacy.

  • So relative to Mylan, this is a very important partnership with us. It's a 65/35 profit share. And to expand on the characteristics of the partnership, I'll turn it over to Renee and then we'll give it over to Brett to further elucidate.

  • Renee Gala - CFO, SVP

  • Thanks, Rick. So, the way that the partnership works, as Rick had mentioned, it's a 65/35% profit share, with Mylan receiving 65% and our company receiving 35%. In addition to the profit share, we are running the development of the program. Mylan pays for 100% of the internal and 100% of the external costs that we incur as part of Phase III development. We also have the ability to earn up to $220 million in milestones on the program. We've earned $15 million of that earlier this year based on enrolling 50% of the long-term safety study.

  • For the outside the US sales, excluding China, which we still have the rights to, we receive double digit royalties on those sales that they would be leading the commercialization of outside the US. And then going back to commercialization in the US, the 65/35% split is something that we came to because we felt, as Rick had mentioned previously, that our acute care focused sales force would be ideally positioned to be able to market revefenacin in the US. We have about 800,000 patients that enter the hospital each year for exacerbations of COPD. And about half of those patients leave the hospital on nebulized therapy. So the fact that we're calling on pulmonologists and respiratory therapists already for the pneumonia indication with VIBATIV, makes this an ideal sell for us in the US. And then I'll just let Brett further comment in terms of the work that we're doing with Mylan on commercialization.

  • Brett Haumann - SVP Clinical Development, CMO

  • And I'll combine that with the question you had about market opportunity. It may help just to very briefly describe the difference between this segment of the market and the handheld space. In the handheld space for COPD, patients are able to use a wide selection of different bronchodilators. And one of the dominant cornerstones of treatment in that segment has been tiotropium, a long-acting muscarinic antagonist that for many years has defined the cornerstone or primary therapy for these patients. Surprisingly though, in the nebulized space this is really poorly served. And in fact patients have not been able to access LAMAs at all in the nebulized segment.

  • The closest they get to are twice daily bronchodilators from the LABA class, or long-acting beta agonist class, of which there are two, BROVANA, which is commercialized by Sunovion, and PERFORMIST, which is commercialized by our partner, Mylan. So they know this space. They have been operating in the space with PERFORMIST for some years. And the market does exist. So you were asking about market opportunity, the beta agonists have been able to establish that this market does exist, in is enduring. There's an enduring population of patients who require long-term maintenance bronchodilation. In fact the combined sales across those two beta agonists approaches about $600 million per year, and that's in the face of generic short-acting agents being available. So this is a sustainable market.

  • And I guess one last point to add is just the introduction of a once daily LAMA, like our product revefenacin, would not necessarily displace the use of those beta agonists because there is the precedent of having a complementary bronchodilator [to apply] and that's seen in the handheld space. So we do believe that this market opportunity exists and we think that Mylan's existing activities in this segment certainly assist us. And has Renee has spoken to, we believe that being able to target the acute care setting, which is an expertise we will bring to the table, will further enhance the opportunity.

  • Unidentified Participant

  • Thank you. That's very helpful.

  • Operator

  • Thank you. (Operator instructions) Thank you. It appears we have no further questions on the phone. I'd now like to turn the conference back to Mr. Winningham. Please go ahead, sir.

  • Rick Winningham - Chairman, CEO

  • Thank you very much, operator. And I'd like to thank everyone for participating in our call today. As I said, we're very excited about the remainder of 2016 as well as 2017. And we look forward to providing future updates for you on the progress of our company. Again, thanks for participating and have a great day.

  • Operator

  • Thank you very much. Thank you everyone for attending today's conference. This concludes the program. You may all disconnect. Good day.