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 would like to turn the call over to Renee Gala, Senior Vice President and Chief Financial Officer. Please go ahead.

Good afternoon, everyone and thank you for joining our third quarter 2015 financial results conference call and webcast. Following our prepared remarks, we will open the call for questions. Joining me on the call today are Rick Winningham, Chief Executive Officer and Dr. Mathai Mammen, Senior Vice President of Research and Development. A copy of the press release can be downloaded from our Web site or you can call Investor Relations at 650-808-4045 and we will 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-Q and other filings with the Securities and Exchange Commission. And now, I would like to hand the call over to Rick Winningham.

Thanks, Renee. Good afternoon everyone and thank you for joining us. We continue to make important progress advancing key programs in our pipeline and executing our commercial strategy for VIBATIV. We filed two INDs for novel product candidates both of which are advancing to Phase I studies late in 2015 or early 2016. We initiated all three studies in the Phase II program for revefenacin, previously known as TD-4208, COPD. We completed the hiring and training of 30 additional VIBATIV sales representatives and medical science liaisons, all of whom were deployed in the field by the beginning of the fourth quarter. With six Phase III studies expected to read out in 2016 and 2017, multiple Phase II programs advancing, high value product candidates progressing into the clinic, a highly productive research organization and a strong financial position, the company is well positioned for both near- and long-term growth. Over the next few minutes, I will provide additional color VIBATIV and revefenacin and then ask Mathai to the same with our novel product candidates that are advancing into Phase I studies. VIBATIV leads our pipeline as the foundation of our acute care commercial strategy in the U.S. We believe that our acute care strategic focus is an important component of value of the company as it allows us to target large and addressable patient populations and indications where our products can be therapeutically differentiated and where the commercial potential is high. Looking across our pipeline, many of our products are designed to treat patients with diseases that present in the hospital setting. By establishing a commercial presence in and around acute care centers we have an opportunity to capture a significant volume of patients at pivotal times starting in the hospital and expanding into the outpatient treatments setting. We believe this…

Thank you, Rick. Today, we're in a new era of our research strategy, one in which we're focusing on designing compounds for targeted delivery to the lung and the GI tract. The idea is that such targeting to the disease tissues intended to create medicine that are high efficacious with minimal side effects in the range of serious medical conditions. More than 15 years of experience has enabled our team to design targeted medicines intended for annihilation with all the requisite biology, distributors and pharmacokinetic properties. Through this work we have created internally a number of important insights relative to tissue target. We are now leveraging these insights to a design of GI targeted compounds, which can be taken orally, enter the wall of the GI tract, have the right tissue dynamics and kinetics to be active, but not be significantly absorbed into the systemic circulation. TD-1473 our pan-JAK inhibitor to treat patients with ulcerative colitis, is the first product candidate to emerge from this new research focus. We believe that TD-1473 can represent a potential breakthrough approach to treating ulcerative colitis. In today treatment paradigm for an ulcerative colitis, injected systemic anti-TNF antibodies are used as the disease progress. These medicines are effective in about half of patients that carry liabilities of increased infection and cancer risk. In many patients they just don't work at all and for some patients for whom the anti-TNF work initially the medication lose efficacy with time, potentially because the disease evolves or because the patient antibodies against the medicine. As multiple JAK utilizing cytokines have been implicated in ulcerative colitis, we believe that pan-JAK inhibitor can be a powerful mechanism for treating the disease. Tofacitinib or xeljanz Pfizer JAK inhibitors has proved for the treatment of rheumatoid arthritis has demonstrated efficacy in the…

Thank you, Mathai. Prior to reviewing the financial results, I would like to remind you that the financial statements of Theravance Biopharma for periods prior to our spin off in June, 2014 were derived from the historical consolidated financial statements of Theravance Inc. And therefore may not necessarily reflect that the financial profile of Theravance Biopharma would have been. Had it been an independent publicly traded company during this period. Now turning to the financials, total revenue for the third quarter of 2015 was $10.7 million with $8.4 million associated with collaborative arrangements. Revenue from collaborations is primarily associated with the license granted to Trek therapeutic for TD-6450 and internally discovered next generation investigational NS5A Inhibitor in development to treat patients with hepatitis-C virus or HCV. Trek has already initiated a Phase IIa clinical study as TD-6450 in combination with faldaprevir and RIbavirin in patients infected with HCV genotype for and this study is expected to read out in 2016. The remaining revenue from collaborative arrangements is associated with our VIBATIV collaboration outside of the U.S. net products sales are VIBATIV in the third quarter were 2.3 million which represented an increase of 9% over the prior quarter and cost of goods sold for the quarter totaled 0.6 million. As Rick noted in his introduction, we completed the expansion of our sales force, which was trained and in the field by the beginning of the fourth quarter. in addition, we continue to see growth in new accounts, year-to-date we have obtained formulary acceptance at a 106 institutions and at over 233 institutions cumulatively. As we discussed in our last call, we experienced a higher than expected percentage of sales to public health service institutions in the second quarter and this trend continued in the third quarter. The gross to net…

Thanks, Renee. We view this as a very exciting and productive time for Theravance Biopharma. We’re making progress in the execution of our commercial strategy for VIBATIV and we expect the FDA to complete its review of our sNDA for concurrent bacteremia in the second quarter of 2016. We’re advancing our first neprilysin Inhibitor in the Phase 1 which represents an excellent opportunity for us with the right partner to pursue multiple cardiovascular and renal indications targeting highly underserved patient populations. Our novel pan-JAK inhibitor TD-1473 for ulcerative colitis and potentially other GI inflammatory conditions is expected to enter the clinic in the coming m months. As noted in the press release. We issued early today we expect a series of FDA events plus numerous data read outs in 2016 and 2017 across our mid and late stage pipeline including two Phase III efficacy studies for revefenacin and COPD in 2016, which along with the Phase III long-term safety study expected to rebound in 2017 will form the basis for our registration package in the U.S. The Phase III FULFIL study of the closed triple combination COPD in 2016 along with an EU regulatory filing at the end of 2016, Phase IIa study of TD-6450 and HCV which is expected to read out in 2016, which is being conducted and paid for Trek. A PDUFA date for concurrent bacteremia application of the second quarter in 2016 in addition to the Phase III registrational study of telavancin and primary bacteremia which is expected to read out in 2017 and will serve if positive for the basis an sNDA application in primary bacteremia. Phase IIb study of Velusetrag and gastroparesis which is now expected to read out in the first half of 2017. As a reminder, the study is being conducted by us but is largely funded by our partner [indiscernible] and the Phase III IMPACT study of the closed triple combination in COPD, which is being conducted in approximately 10,000 patients and is expected to read out in 2017 with the U.S. regulatory filing planned in the first half of 2018. In closing, with six Phase III studies expected to read out in 2016 and 2017 multiple Phase II programs advancing with high value product candidates progressing into the clinic are productive research organization and the strong financial position the Company is well positioned to create value for patients, the healthcare system, and our shareholders. Now I would like to turn the call over to the operator for questions.

[Operator Instructions] Thank you. Our first question comes from the line of Tazeen Ahmad of Bank of America. Your question please.

This is [indiscernible] on for Tazeen. Lot of exciting things coming up in the future, I wanted to ask what you think are really key catalyst coming in 2016 and there is a lot of Phase III read outs but which product do you think could advance the most in the coming year?

Thanks, this is Rick Winningham. I'll take that. I think clearly for us the revefenacin Phase III efficacy studies in 2016, those are two Phase III studies both of which were readout in 2016 and I think we will provide valuable information on product and its value relative to patients. Clearly, the telavancin Phase III registration study in bacteremia we're reading out 2017 as well as the revefenacin long-term safety study in 2017. Both of those are quite important revefenacin because it completes the data necessary to file for approval in the United States and telavancin or VIBATIV the registrational program in bacteremia because it provides the third indication for VIBATIV, having VIBATIV really contain the broader set of indications with any branded gram gram-positive antibiotic. I think equally for us with the light sage programs, the progress that we've made in research over the last couple of years in our neprilysin program for heart failure and renal disease as well as the JAK program for ulcerative colitis because of the uniqueness of our approach can both be value driving for the Company. And I might have Mathai just another moment on our GI targeted pan-JAK inhibitor.

Hi, Peter. Mathai here. So our pan-JAK inhibitor, I think the right way to think about this is to look at some of the Phase II to Phase III data coming out of alternate mechanisms and look at how we might position a compound that has efficacy that might approach that of Tofacitinib Phase II program. We don't know all the details there Phase III success recently, but if it's truly GI restricted could have the tolerability of some of the safer programs out there like S1P1 modulator. We see this is as potentially really important program that will mature over the next 1 or two years so it's not in the next quarter or two, we will be plan on doing next year if take us program forward into healthy volunteer to look at the extent of GI restriction. Our preclinical model suggest that it's a nicely GI restricted and should lead to minimal systemic exposure and I am hoping to confirm those results in human being next year. And then we onto Phase II potentially not only in ulcerative colitis but maybe another indications as we indicated in the call just now. So I think it's potentially big winner of a program, little bit more time needed to mature completely but very excited about that.

Great. Thanks a lot guys.

Thank you. Our next question comes from Brian Skorney of Robert W. Baird. Your line is open.

Hi, this is [Nina] (Ph) in for Brian. I have two questions the first one is TD-714 and TD-1473, could you layout for us the Phase I timelines as well as if in the most welcoming dose there will be any biomarkers that you're going to evaluate in order to give an indication of drug activity?

Yes, I'll take that so let's start with TD-1473, so we see most of this coming year 2016 being in different segments of the Phase I program first the single ascending of study and then multiple ascending dose study. It's a good question you're asking with respect to biomarkers we're actually still thinking that through. If we incorporate such a program which would give us a feel for target engagement, productive target engagements in gut, we would initiate that towards very end of next year, but we remain undecided on whether we would conduct such a small study as part of the mass for go on to perhaps development Phase II study. So we have not yet decided which way we'll go with that. With TD-0174, this is our first NEP inhibitor candidate. As we indicated in the call this is the first of three NEP inhibitor candidates. This particular one should go into Phase I evidently in December before the end of the year and again we'll spend a larger chunk of next year in both [indiscernible] studies. The key there is to look at biomarkers. We will be able to get read out of productivity systemic NEP inhibition in that program in a combination of both [indiscernible] studies. We should be able to assess importantly pharmacokinetic, it's important to us to be at least [indiscernible] product, consistent exposure be safe. And importantly, our clearance should be low and largely non-renal, because there is a level of uncertainty always when such taking a compound forward into Phase I based on preclinical data, we have two additional compounds, two additional shots on goal to give us confidence that we will come out at the end of year or next year with a NEP inhibitor that we think can be best-in-class and can compete effectively in the marketplace is a really important medicine. So the short answer is maybe biomarkers with the JAK program and yes definitely biomarkers with the NEP program.

Excellent. Thank you and my other question is and you can talk about the Axelopran product at all but the last time we heard about it you are looking at potentially during Axelopran coated opioids, is that something that you are still looking at and do you have any plans on running pivotal studies with the agent and potentially partnering the agent?

Sure. So, this is Rick Winningham. And I appreciate you bringing up that program, but we proceed a data and pain week about a month ago on our fixed dose combination of Axelopran with oxycodone. So a proprietary coat technology that we've developed utilizing Axelopran where we can spray coat oxycodone, we believe we can spray coat any available either normal opioid or abuse resistant opioid. The findings in the study presented at pain week demonstrated that Axelopran doesn’t alter of the systemic exposure to oxycodone when delivered as a fixed dose combination relative to co administration of the individual tablets. We believe this is a very large and underserved market because then with a coated Axelopran opioid you won't might be able to actually have a product for severe pain relief without the opioid induced constipation. I think relative to where were going, we’re in partnering conversations around this program and will provide and update to investors at a future point in time but clearly the ability - the flexibility that the coding technology provides has the stimulated significant partnering interest around this program.

Great. Thank you.

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

Well thank you very much. I would like to thank all of you for joining us for our third quarter update call. We've got very exciting fourth quarter and we are looking forward to an event filled 2016. Again thanks for participating and have a great day.

This concludes today’s conference call. We thank you for your participation. You may now disconnect.