Earnings Labs

Theravance Biopharma, Inc. (TBPH)

Q1 2016 Earnings Call· Mon, May 9, 2016

$16.69

-0.42%

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Transcript

Operator

Operator

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.

Renee Gala

Analyst

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 question. 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’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 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

Analyst

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 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 are investigational, our once daily nebulized LAMA continuous 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 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 adorable 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 addition color on…

Renee Gala

Analyst

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% 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 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 repertory products in development GSK and Innoviva. We are entitled to receive 85% 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.

Rick Winningham

Analyst

Thanks, Renee. To recap we’re excited about the lineup of potential essentially 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. In completion 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 and getting drugs across the finish line and end of 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.

Operator

Operator

Rick Winningham

Analyst

Okay, 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.

Operator

Operator

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