Theravance Biopharma Inc (TBPH) 2016 Q1 法說會逐字稿

Ladies and gentlemen, good afternoon. At this time, I 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 like to turn the call over to Renee Gala, Chief Financial Officer. Please go ahead.

Good afternoon, everyone and thank you for joining our First Quarter 2016 Financial Results Conference Call and Webcast.

With me on the call today is Rick Winningham, our Chief Executive Officer; who will provide an update on our priority programs and review anticipated key clinical and regulatory milestones for 2016. I will discuss our financial results for the quarter and then we will open the call questions.

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'll be happy to assist you.

We'd 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?

Thanks, Renee. Good afternoon, everyone and thank you for joining us. We continue to make significant progress in advancing our priority programs to key milestones which represents potential value creating events for the Company.

These programs are TD-0714, our Neprilysin or NEP Inhibitor for the treatment of Cardiovascular and Renal Diseases for which we have reported compelling data in a Phase 1 Single Ascending Dose Study and are expecting to report on the Multiple Ascending Dose Study in the second-half of the year.

TD-1473, our GI targeted pan-JAK Inhibitor to treat Ulcerative Colitis for which we have Phase 1 Single Ascending and Multiple Ascending Dose Studies underway. We expect to Phase 1 data in the second quarter, which could pave the way for a Phase 1b study in patients later this year.

Phase 3 program for Revefenacin our investigational, once daily nebulized LAMA continues to enroll rapidly and is on track for reporting two efficacy studies in late third quarter or early fourth quarter of this year followed by a 12 month Safety Study in 2017 and subsequent NDA filing expected in late 2017.

Lastly, we made progress in implementing in our commercial and label expansion strategies for VIBATIV. And we are pleased with the positive PDUFA decision on our supplemental NDA for Concurrent Bacteremia which we just received from the FDA.

Looking ahead, we remain enthusiastic about our prospects in 2016 which include key clinical and regulatory milestones, we have durable and robust business model, strong balance sheet which includes proceeds from our recent public offering and significant funding from partners, a rich portfolio of assets at various stages of development and a proven track record of success which we intend to build upon this year and in years to come.

Now, I'd like to provide some additional color on our priority programs. In our NEP Inhibitor program, our goal is to develop a medicine that has the potential to be combined with complementary mechanisms to treat Chronic Heart Failure and other serious Cardiac and Renal Diseases. The Phase 1 program for TD-0714 is progressing well. Last quarter we reported favorable safety, PK and biomarker data from the Phase 1 Single Ascending Dose Study in healthy volunteers.

The study met our target product profile of sustained 24-hour target engagement based on elevated cyclic GMP, non-renal clearance and favorable safety and tolerability. Finding of the non-renal clearance is important because a number of patients with Cardiac and Renal Diseases may benefit from NEP, in addition have variable or compromised renal function. The Phase 1 Multiple Ascending Dose Study in healthy volunteers is underway and should read out in the second-half of the year.

We believe 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 Novartis's Entresto including once daily dosing be oral or IV routes sustained 24-hour target engagement and importantly non-renal clearance.

Our second Phase 1 program is TD-1473, a pan-JAK Inhibitor specifically designed for targeted delivery to the gastrointestinal tract for the treatment of a range of Inflammatory Intestinal Diseases including Ulcerative Colitis, a debilitating disease that affects roughly 700,000 patients in the U.S.

Our goal is to develop a treatment option for UC and other GI diseases with a more favorable benefit risk profile than approved and late stage therapies that are in development.

These include anti-TNFs and Tofacitinib, an oral small molecule JAK Inhibitor in development by Pfizer, which have vary degrees of efficacy, but all carry the risk of systemic immune suppression. TD-1473 is designed to be taken orally and to pass through the stomach and small intestine, penetrate the membrane of the colon and have the right tissue dynamics and kinetics to block immune response at the side of inflammation in the colon, but without being released into the broader systemic circulation to any significant degree.

In March, we presented exciting pre-clinical data on our GI-JAK program in two poster presentations at the European Crohn's and Colitis Organization Conference. One study on the colitis models showed TD-1473 potent and selective pan-JAK Inhibitor capable of achieving high drug levels in the colon without significant systemic exposure following oral dosing.

The study also showed TD-1473 had a comparable reduction in colitis-related disease activity to Tofacitinib with no measurable immune suppressive activity.

In the second study, comparing the therapeutic potential of the colon targeted JAK inhibition to systemic JAK inhibition in the same pre-clinical model.

Data show that the administration of Tofacitinib directly into the colon achieved similar reductions in colitis-related disease activity as orally dosed Tofacitinib. But the colonic administered dose resulted in significantly lower systemic exposure. These findings are particularly relevant to TD-1473 as they suggest a GI targeted JAK Inhibitor may provide clinical efficacy in the treatment of Ulcerative Colitis without the need for systemic exposure and the risk of systemic side effects.

Based on our pre-clinical findings, we believe that TD-1473 could represent a potential breakthrough approach and competitive advantage in treating Ulcerative Colitis and other Inflammatory Intestinal Diseases. We are currently conducting a Phase 1 study of TD-1473 which is expected to be completed in the second quarter. Our primary objective is to assess the safety and tolerability of Single and Multiple Ascending Doses in healthy subjects.

A key secondary objective will be the characterization of pharmacokinetics related to TD-1473. We will be assessing fecal [ph] concentrations to determine presence of TD-1473 in the colon as well as plasma concentration to determine presence of TD-1473 in the blood stream in an amount small enough to indicate passage through the colon into the membrane. Assuming positive results from the ongoing studies, we intend to initiate a Phase 1b study of TD-1473 in patients with moderate Ulcerative Colitis later this year.

Now, turning to our late stage pipeline, the Phase 3 program for Revefenacin our investigational nebulized once daily Long-Acting Muscarinic Antagonist or LAMA for the treatment of COPD is progressing well.

We recently completed screening in the Phase 3 program which include two replicate three month efficacy studies and a single 12 month safety study the combined will enroll approximately 2,300 patients. We believe that the rapid pace of enrollment in our studies indicates strong interest among patients and physicians in a once daily nebulized COPD treatment.

As you know, LAMAs are the gold standard of handheld device market, but there are no nebulized LAMA treatments currently available for patients with COPD Those that require nebulized therapy. Roughly 9 percent of COPD patients use nebulizers for ongoing maintenance therapy and about 41 percent of COPD patients use nebulizers intermittently for bronchodilator therapy. We believe there is a large commercial opportunity for Revefenacin as the first once daily nebulized bronchodilator for COPD with an opportunity to become a standard of care in this market segment. We are very excited to see this important therapy advancing towards the market.

We believe that Revefenacin aligns well with our commercial focus on the acute care segment. There are about 800,000 patients admitted every year to U.S. Hospitals for worsening of COPD. About half of those 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 where we currently market VIBATIV gives us the opportunity to capture a meaningful number of patients at pivotal times. Starting in the hospital and expanding into the outpatient treatment setting.

We believe that our acute care strategic focus is an important value driver for 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.

Turning to VIBATIV, we continue to make good progress in implementing our commercial strategy. Our national sales force is driving growth in both the hospital and the outpatient setting including 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 products commercial potential. Our 250 patient Phase 3 registrational study in Bacternia is continuing to evolve and we expect the study to complete in 2017 or 2015. If successful, we will have the only branded antibiotic with an indication for Complicated Skin and Skin Structure Infections HABP/VABP and Bacteremia.

Our TOUR registry program also has strategic importance as it is designed to collect real world data which couldn't form potential indications for the product.

Earlier today, we announced approval of our sNDA allowing for the addition of new clinical data in the VIBATIV label, describing the treatment of patients with Concurrent Bacteremia in cases of Complicated Skin and Skin Structure Infections as well as HABP/VABP. Bacteremia continues to represent a significant unmet medical need. Concurrent Bacteremia which in its most serious form is fatal occurs when Bacteremia spreads from the initial site of infection and enters the blood stream.

As a secondary infection, it introduces significant challenges to the treatment of the primary infection as well as the Concurrent Bacteremia itself. This serious health threat is compounded by a relative lack of affective treatments for these infections. This broad and growing collection of data supports our position with VIBATIV as a key therapeutic option in the indications for which it is approved, in particular when Vancomycin or other therapies are not suitable. VIBATIV is a valuable asset for our company and we look forward to continuing to expand its utilization in the market place.

And now I'd like to turn the call over to Renee to provide the financial update.

Thank you, Rick. Revenue for the first quarter of 2016 was $18.4 million including revenues from collaborative arrangements of $15.1 million and net product sales of VIBATIV of $3.3million. Revenue from collaborative arrangements was primarily driven by a $15 million milestone received from Mylan related to our Revefenacin program. Revenue from VIBATIV in the first quarter was entirely related to product sales in the U.S. and represented a 9 percent increase in U.S. net product sales compared to the prior quarter.

R&D expenses for the first quarter of 2016 were $35.7 million representing a decrease of $0.3 million compared to the same period in 2015.

SG&A expenses for the first quarter of 2016 were $23.6 million representing an increase of $1.8 million compared to the same period in 2015. The increase was primarily due to cost associated with VIBATIV commercialization.

Cash, cash equivalents and marketable securities as of March 31st totaled $214.5 million. The quarter end cash balance excludes $37.5 million in receivables from collaborative arrangements and a $107.7 million in net proceeds from the Company's recent public offering.

Our financial guidance for 2016 remains unchanged from the guidance communicated in the last quarterly call. In 2016, we expect to incur full year operating loss excluding share based compensation in the range of the $120 million to a $130 million.

In addition to the internal program that Rick discussed earlier, I'd like to remind you of our economic interest in certain respiratory products in development by GSK and Innoviva.

We are entitled to receive 85 percent of the future potential royalty or milestone payments that may be made by GSK pursuant to its agreement with Innoviva. These products include the Closed Triple currently in development for both COPD and Asthma and MABA, currently, in development for COPD.

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

Thanks, Renee. To recap we're excited about the lineup of potentially value creating events expected in 2016.

These include completion of Phase 1 study for our NEP Inhibitor TD-0714 in the second-half of the year.

Completion of the Phase 1 study of pan-JAK Inhibitor TD-1473 in the second quarter which could enable us to initiate a Phase 1b study in patients later this year.

Completion of the Phase 3 efficacy studies for Revefenacin in the late third quarter or early fourth quarter.

Andcompletion of the Phase 3 FULFIL study of the Closed Triple in COPD being conducted by GSK with an expected regulatory filling in late 2016.

In closing, we're pleased with the progress we've made thus far in 2016. We have productive research engine and a pipeline of high value assets, a robust business model, a strong financial position and a team with the track record of success in getting drugs across the finish line and into the market. We look forward to making additional progress across our pipeline and providing meaningful business updates throughout the course of the 2016.

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

Thank you.

(Operator Instructions)

OK, thank you, operator. It appears that we don't have any questions today. So I'd like to thank everyone on the phone for participating. We look forward to finishing the remainder of 2016 in a very strong manner. And have a great day.

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