Ladies and gentlemen, good afternoon. At this time, I'd like to welcome everyone to the Theravance Biopharma Conference Call. [Operator Instructions] Today's conference call is being recorded. And now, I would like to turn the call over to Alex Dobbin, Head of Investor Relations. Please go ahead.

Good afternoon, everyone. Thank you for joining our conference call and webcast to discuss our Fourth Quarter and Full Year 2017 financial results. With me on the call today are Rick Winningham, Chief Executive Officer; Renée Galá, Chief Financial Officer; and Brett Haumann, Chief Medical Officer. Following our prepared remarks, we'll open the call for questions. A copy of the press release and the slides accompanying this call can be downloaded from our website, or you can call Investor Relations at 650-808-4045, and we'll be happy to assist you. Prior to our update, we’d like to direct your attention to Slide 2, of the deck and remind you that this conference call will contain forward-looking statements, which involve certain risks and uncertainties, including statements about our product pipeline, expected benefits of our products, the anticipated timing of trial results and regulatory filings and expected financial results. Information concerning factors that could cause results to differ materially from our forward-looking statements are described further in the Company's filings made with the Securities and Exchange Commission. And, now I’d call your attention to Slide 3 and hand the call over to Rick.

Thanks, Alex. Good afternoon, everyone, and thank you for joining us. The last 12 months have been a period of significant progress at Theravance Biopharma. Having advanced several programs within our portfolio across key milestones. We reported important clinical results across a range of therapeutic areas in phases of development. Submitted an NDA and signed a strategic partnership with the Janssen Biotech. The strategic partnership with the Janssen surrounding our intestinally restricted JAK program for inflammatory intestinal disease represents a key point in the evolution of our company. The intestinally restricted JAK program is the first to emerge from our research efforts to create localized medicines for localized disease. These insights began with our work in the lung, which led to the discovery of revefenacin, to those understandings, we had a depth in immunology as well as leveraged our knowledge in other organ systems such as the GI tract. Key to our progress has been our growth in understanding of both metabolism and absorption and integrating all of that knowledge into chemical design. We are excited about the evolution of our Company's focus on leveraging insights into the properties of local tissue and suppression of specific cytokines in these tissues. 2018 will be an important year for Theravance Biopharma as we intensify our focus on strategic priorities, drive clinical execution and advance programs from our validated research platform towards clinical development. With Trelegy Ellipta launched in the United States and multiple strategic partners secured to complement our internal efforts, we are well positioned to execute on the most important opportunities in our portfolio. On our call today we will highlight our achievements in 2017 and discuss our key upcoming events and milestones. Before doing so, I'd like to provide an update regarding VIBATIV and the Phase 3 bacteremia study as…

Thanks Rick. I'll begin on Slide 4, with our JAK inhibitor program TD-1473 is a novel potent orally administered and intentionally restricted pan-JAK inhibitor with the potential to treat a range of inflammatory intestinal diseases including ulcerative colitis and Crohn's disease. TD-1473 is designed to remain localized and only act within the gut wall, thereby maximizing local anti-inflammatory efficacy and minimizing the systemic exposure that would otherwise lead to immunosuppression. As Rick, mentioned we recently executed a global collaboration agreement with the Janssen for the joint development and commercialization of 1473 and related backup compounds. As we discussed at the announcement of our agreements, this collaboration has the potential to benefit both 1473 and the company in a number of ways. First by immediately harnessing the expertise of Janssen we believe we can optimize the clinical strategy and execution of 1473, which is of particular importance in this competitive field of inflammatory bowel disease. Second, this collaboration allows us to accelerate and expand the scope of the development program with a plan to pursue multiple indications in parallel starting this year. And finally, our goal is to maximize the worldwide commercial opportunity for 1473 for Theravance Biopharma and our shareholders. And we think having Janssen as our partner now in advance of our registrational programs will enhance our overall probability of success and support achievements of this objective. We were pleased with the data from the first cohort of patients in our Phase 1b study in ulcerative colitis. As it demonstrated target engagements and biological activity and provided us and Janssen with confidence in initiating the Phase 2b/3 induction and maintenance study in ulcerative colitis and the Phase 2 induction study in Crohn's disease in second half of 2018. We don't view the remaining cohorts as gating our progression into…

Thanks, Renée. We're pleased with the progress across our pipeline in the last 12 months and we're very proud of the entire Theravance Biopharma team for their achievement this past year. 2018 as I said will be an important year for the company as we intensify our focus on strategic priorities, drive clinical execution and advanced programs from our validated research platform towards clinical development. We're well positioned to execute on the most important opportunities for value creation as shown on Slide 8. These priorities include optimizing the development of TD-1473 with Janssen, where we plan to initiate a large Phase 2b/3 study in ulcerative colitis and a Phase 2 study in Crohn's in the second half of 2018. As both Renée and Brett mentioned, advancing TD-9855 towards registrational program in patients with symptomatic nOH, following the results from our exploratory Phase 2a study expected late in the first half of this year. In partnership with Mylan, the potential approval and launch of revefenacin with an assigned PDUFA date of November 13 this year; and finally progressing our inhaled JAK inhibitor for serious respiratory disease into the clinic in the late 2018 or early 2019. This is the next program from our research platform aimed at discovering localized medicines. Before I close our remarks, I'd like to spend a few moments expanding on our research, which underpins our progress and development since our entire pipeline is internally discovered. Currently the research efforts at Theravance Biopharma are focused in the areas of inflammation and immunology. Our goal and research is to create localized medicines to target diseased tissues without systemic exposure in order to enhance the therapeutic index beyond systemically available treatment options. Through our revefenacin and TD-1473 programs we developed a deep expertise in medicinal chemistry tissue absorption in drug metabolism and we’ve leveraged those learnings in building a research platform targeting localized therapy for localized disease. This platform and our growing foundation of expertise in immunology have given rise to a portfolio of JAK inhibitors and research including our inhaled program for serious respiratory disease as that we intend to bring in the clinical development in late 2018 or early 2019. In 2018 we’ll spend more time talking about the programs we’re advancing towards development and how we see those programs contributing to our purpose of creating medicines that help improve the lives of patients suffering from serious illness. Now I'd like to turn the call over to the operator for questions.

Thank you, sir. [Operator Instructions] And our first question comes from Geoffrey Porges of Leerink Capital. Your line is now open. Again, Geoffrey, your line is now open. Please check your mute button. And our next question comes from Josh Schimmer of Evercore ISI. Your line is now open.

Thanks for taking the questions. Two of them if I may. First on TD-9855. If you could help frame expectations or the hurdle rate that you're looking for from this dataset to support advancing in the Phase 3? What kind of response rates? Sort of specific endpoint metrics you’re looking for? And then second question, on VIBATIV given the revenue trajectory relative to the commercial spend, is that an asset that you continue – would continue to invest in commercially or consider out-licensing just to conserve capital to invest in other development programs? Thanks very much.

Okay, Josh. It was a little difficult to hear you, but I'll try and repeat the questions. One of them was TD-9855, the hurdle rate that we expect to see that would – that we believe would merit progression in the Phase 3. And the second question was on VIBATIV and sort of how we look at that asset going forward. I will touch on VIBATIV and then make a couple of comments on TD-9855 and then turn it over to Brett. VIBATIV, we’ve cut back on our spending clearly. If you look at the acute care organization that we have – that sells VIBATIV, we would expect that that the acute care organization would begin to transition towards the promotion of revefenacin in the hospital setting. It's important to understand that the patients targeted with revefenacin are largely GOLD stage 3 and 4. These are patients many of whom that unfortunately go through the hospital in their journey through the healthcare system. And while in the hospital many are placed on nebulized therapy and given that we have a once a day nebulized therapy, there are certain efficiencies in the healthcare system specifically in both acute care and long-term care to a once a day long-acting muscarinic antagonist. The other obvious importance is following those patients as they go through the system, and of course while we will focus on the acute care setting with our organization Mylan will focus on primary care pulmonology et cetera in the outpatient setting. So we have been and continue to monitor our investments in VIBATIV quite carefully and the acute care organization will be leveraged for the launch of revefenacin given the patient population that we're targeting. Now in expectations for TD-9855, clearly what we're looking for is very, very strong signal here from the patients that we have in the 2a study. And specifically durability of the fact of those patients that the drug has it at four weeks and that developing a greater understanding of what patients in fact respond to TD-9855. So I'll turn it over to Brett.

Thanks, Rick. Josh, I think a great question. Really what I'd add to what Rick has already described is that we recognized during the course of last year that as valuable a single dose data would be and indeed that was the way the study was originally designed, generating this durability data, the opportunity to assess how patients are doing over time when they take this therapy is now really central importance. That's become in our minds the most important part of this study and that's why we extended the duration of that piece of work. So just as a reminder, we are enrolling patients with active disease with nOH who are symptomatic. And importantly in the space it's not just blood pressure that we're looking to modulators, we are looking to improve symptoms and function in these patients. As a reminder, the only available therapy, the alternate available to patients at the moment are a very short duration, midodrine is a drug which is approved only for blood pressure and droxidopa which is the only other currently available therapy in the registration study. So it was not able to demonstrate durability beyond one week and in fact that's reflected in the current label. Our purpose in this current study is to look at durability at least two to four weeks and the opportunity to evaluate patients for longer if they continue to benefit. Of course, this is all in the context of pursuing an efficient progress through development including a rapid transition into Phase 3. We alluded to the fact in our script that we have encouraging interactions with regulatory agencies in this regard, this is an orphan designation and I think there is a recognition of the importance of bringing new durable therapies to the market. So all of those I think are certainly going to inform our physician. And as we mentioned, we look forward to reporting on data the middle of this year from that durability assessment in the current study.

And then how should we be thinking about the accounting for revefenacin in the P&L. Renée Galá: Good question. Josh so as we are in a position, where the profit shares, 65% Mylan, 35% Theravance Biopharma and Mylan will be booking the sales on their income statement and they are essentially the distributor of revefenacin. So, what that means for us as the 35% share of the profits, is if we're in a loss position, we'd expect to book that net 35% loss through operating expense, whereas if we're in a profit position once we get to a certain point and the launch, then we would expect to book that as collaboration revenue, our 35% share. But it would not be booked as product sales since Mylan is the primary distributor here.

Got it. Thanks very much.

Thank you and our next questions comes from Brian Skorney with Robert W. Baird. Your line is now open.

Good afternoon guys, thanks for taking my question. Just a kind of follow-up little more on the nOH data, and who we should really be looking at and thinking about later this year. I think but Northera data in terms of some of the symptom data points, there is a focus on the OHSA which is a measure of dizziness. Maybe just comment on thoughts around that and evaluating that is one of endpoints there. And also I know the primary is seated systolic blood pressure, are you guys measuring standing systolic and isn’t that the primary measure of our orthostasis and just as a final question I there are a lot of controversy a number of years ago around ProAmatine and lack of post marketing studies, to get a basis for full approval. Just wondered if you guys have any insight into the regulatory path for ProAmatine and whether or not I know they did do some subsequent Phase 4 studies and just whether there is the potential for that drug to get full approval and how you would kind of think about development. If that were the case. Thanks.

Thanks, Brian. I will take the questions in order and I am sure my colleagues will comment as well. But just to pick up on the point you raised around end-points, you clearly know this space well and absolutely OHSA the instrument which is now being really confirmed by the agency as being validated in this space is an important end-point. And so that's included in our assessments and we believe we’ll play a central role certainly in Phase 3 program, as well. But it isn’t the only assessment that we're looking at, so in addition we've been looking at blood pressure measurements, we're also looking at additional assessments of function. I alluded in script that we're looking at standing time as well. Really all of this is at this stage focused on getting an overall impression of how patients are benefiting or not from therapy and how they're able to improve on the functionality bearing in mind that these are really patients who are completely bed-ridden and unable to either work or indeed even to get around the house. You mentioned the seated and standing systolic blood pressure both are incorporated in the current study but I will restate that actually our appreciation for symptoms and the function is as important in this current piece of work. So although, we're measuring blood pressure and indeed it was used as the primary endpoint for the single ascending dose portion of the study, the durability assessments, the repeat dose assessments will include an evaluation of all of their function including their symptoms. So it's a much more holistic assessment.

Bret would you just like to comment on sort of very broad brush, your regulatory approach.

So I think you asked earlier about pre versus post marketing requirements and without divulging the full extent of our regulatory interactions, I think we’ve recognized that the way in which previous therapies have been developed whilst it may be efficient haven't necessarily lead to full approval. Our ambition, our goal with this program is not only to seek an efficient development program focusing on patients with the highest unmet need but also to do it do so in a comprehensive fashion, meeting the requirements of the agency, ultimately ideally to seek full approval not conditional approval. And of course that, you'll see more of that incorporated in our Phase 3 strategy, which we'll plan to disclose as time goes on.

Okay, thanks guys.

Our next question comes from Louise Chen of Cantor. Your line is now open.

Hi, thanks for taking my questions, so first question I had here is we often get the question that now that you’ve partnered your JAK, what’s your strategic vision for the company here, you’ve partnered most of your major projects and they are in different therapeutic areas, so how do you see your business plan unfolding. Second question I had was on your inhale JAK and you talked about maybe if you could give more color on that opportunity and who you might compete with in this space. And then last question I had was just on some housekeeping items the less than 25 million that you expect to block in 2018 for J&J is that spread evenly throughout each quarter. And then could you talk a little bit about your R&D progression spending in 2018 and then for revefenacin is it that we should expect the revenues to start coming in the fourth quarter of 2018. Thanks.

Okay, Louise I'm going to just start quickly on the strategy and then touch for a moment on the inhaled JAK program. Over the course of time and the evolution of the company you will have seen us move from your royalty stage royalty like deals to profit share deals and then will likely evolution would be at some point in time at least from a geography perspective retain a 100% of the economics on assets clearly 9855 being a very, very focused product in terms of the prescriber base and a very efficient at least as it looks today a very efficient Phase 3 pathway to market. Clearly that would be a product that that we would retain rights to and in fact look to sell ourselves with a very small commercial organization that would be effectively built on the back of the infrastructure, we've already established to support, acute care would be a different sales organization but it would share the infrastructure. So I think we're clearly moving in the direction of capturing more and more of the downstream economics, partnerships will continue to be important to us as we proceed down the path, the strategic path for the company. But with moving to both profit shares and then 100% profit in specific geographies as we evolve. Now the JAK program for inhalation delivery, I think this builds both on all the work that went into the JAK program in the gut, as well as the knowledge that we've built up over time on inhalation. I mean clearly, what we're looking for here is for long retention but minimal plasma exposure, again long duration of activity. But the broad anti-inflammatory activity affecting a number of cytokines that other products being targeted specifically the biologics simply can affect because of their specificity. But in fact affecting those targets in the lung, achieving lung concentrations and then being cleared through first pass metabolism such that we don't – our goal is to not see systemic immune suppression much as what the observation is have been to-date in the TD-1473 program. So I think we're progressing heading into the clinic but we're quite excited about this next program, what it might be able to deliver to patients and you'll hear more from that as we go forward in 2018.

Okay. Renée Galá: Louise, I'll address your questions on the financials. With respect to the $25 million that we expect to recognize in 2018, I would anticipate that being in the second half of 2018, primarily the way the guidance works is you essentially have to allocate the $100 million over what's referred to deliverables related to the collaboration. And for us we have a couple of clinical studies that we've referred to that will be conducting, will spread some portion of the $100 million over the life of those studies and there will be some amount that is related to the delivery of the actual data for both the Phase 2 induction portion of UC and then the Phase 2 Crohn's study. So that's how I would think about the $25 million in 2018 and then the remaining $75 million broadly speaking. With respect to our R&D progress, I would expect our research expenses to be fairly flat over the course of the year, we don't generally break out research versus development. But broadly speaking if you translate that to activity researches is generally flat throughout the year. And that of course we would expect to have higher expenses in the second half of the year related to the programs that we're conducting related to 1473. And then we'll have to see what happens with respect to 9855 as we noted on the call, our guidance range is a bit wider this year given a number of moving pieces. But we're excited to have that number of opportunities to invest in over the course of 2018. And then the last piece, was your question on revenue related to revefenacin. So we would expect to receive, we hope obviously to receive approval in November in line with the PDUFA date. And then we're working closely with our partner Mylan with respect to the exact timing of launch. Obviously, we're working diligently to prepare for commercialization as Rick had mentioned, our acute care sales force will be focused on that. I wouldn't – I certainly wouldn't expect to be in a profit position, initially I would expect to be on a loss as we first start launching the product. And as I'd mentioned 35% of the loss when we're in that position will be recognized an OpEx, 35% of the profit we’re in that position will be recognized as collaboration revenue. Does that answer your question?

Yes, thank you.

Yes, Louise, I’ll just add one other comment just to frame it for people for the inhale JAK program in terms that you may have heard from other companies in biologics. But the important aspect of the pan-JAK inhibitor and being able to deliver it into the lung safely as in fact, the ability to affect both pH2 and non-pH2 driven asthma. And I think this is particularly exciting for us as we learn and understand more about the specific cytokines and the progression of those cytokines in asthma exacerbations. And I just ask Brett since he's got quite a bit of experience in this to comment.

Thanks Rick. I think just a few things to add of course, Rick has touched on the fact that this would still be a broad based anti-inflammatory. It's quite regrettable that actually in the markets, despite the fact that patients are on maximal inhaled therapy. We're still as many as half a million U.S. citizens with severe asthma, who do not have proper control of their asthma. Despite being on maximal doses of available therapies, the only alternative they have at the moment is to move towards systemically available biologicals. And those have their own side effects, in fact analogous to what we've been talking about in the GI space. So our vision here is to take the same building blocks as we've had before with the GI, look at the targeted approach in the lung, which would focus that broad based anti-inflammatory effect only in the lung and avoid the systemic liabilities. That some of these other biologicals may carry, for example, in the IL5 or anti-IL5 space, anti-IL4 and IL13. So we think they have a broad based approach but it certainly will be building on a strong research platform that has invested now heavily and looking at localized disease and targeting our medicines, our localized medicines to treat those diseases.

Thank you. And it appears we have no further questions on the phone. I would now like to turn the conference back over to Mr. Winningham. Please go ahead, sir.

Great, thank you operator. I'd like to thank everyone for participating and today we look forward to bringing new updates throughout the course of the year. And as I mentioned earlier in my remarks, we look forward to having an R&D Day where we can delve more deeply into the programs that we covered on our update today. So have a great day and we look forward here at Theravance Biopharma to a great 2018.

Ladies and gentlemen, this concludes today's conference call. We thank you for your participation and you may now disconnect. Everyone have a great day.