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Theravance Biopharma, Inc. (TBPH)

Q2 2015 Earnings Call· Mon, Aug 10, 2015

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Transcript

Operator

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

Renee Gala

Analyst

Good afternoon, everyone and thank you for joining our second 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 if 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.

Rick Winningham

Analyst

Thanks, Renee. Good afternoon everyone and thank you for joining us. In the second quarter of 2015 and year-to-date we have focused on executing our strategies to advance 4208 to registrational Phase 3 program to position VIBATIV as an important treatment for patients with life threatening infections and advance for two lead research stage programs towards the clinic. We’re pleased with the progress we have achieved with our programs to-date, and believe we have multiple opportunities to generate value across the entire portfolio. While we remain encouraged by the quarter-over-quarter gain in VIBATIV U.S. net sales between the first quarter and the second quarter, we’re facing some issues that are slowing down our projected U.S. sales ramp on the second half for the year. These issues are driving our decision to reduce our full year VIBATIV net sales guidance for the product in the U.S. as we announced in our press release today. I’ll start with what we believe is working well in VIBATIV commercial strategy both in the U.S. and globally and then discuss the U.S. issues specifically. Total revenue related to VIBATIV in the second quarter, revenues were 7.1 million. Our revenues comprised of net sales of VIBATIV with 2.1 million which was an increase of 66% over the prior quarter and revenue from VIBATIV collaborations are 5 million. Our strategy to leverage regional partners outside the US to expand our commercial reach and build VIBATIV into a globally looked brand is progressing well. In May, we established the development and commercialization agreement with SciClone Pharmaceuticals for China and adjacent territories. China is the strategic market for VIBATIV. In China we and our partner SciClone intend to first pursue development and commercialization of VIBATIV in hospital acquired bacterial pneumonia and ventilator associated pneumonia. Additional indications may include complicated…

Mathai Mammen

Analyst

Thanks, Rick. Good afternoon. I will begin with our many developments outside of VIBATIV; first, TD-4208 where phase 3 initiation; second, Velusetrag enrolling in a phase 2b study; and third TD-8954 in phase 2 development and a subject of discussion with regulators. First 4208, 4208 is an investigational one theory long-acting muscarinic antagonist or LAMA for patients with COPD. But most valuable and exciting of our 4208 is its potential to fill in important therapeutic needs for patients with COPD who want or need nebulizer therapy. 4208 has the potential to become the first once daily nebulized bronchodilator for the treatment of COPD and it become the standard of care in the nebulized bronchodilator therapy category we and our partner Mylan uses as a compelling market opportunity. We are on track to initiate the registrational phase 3 program in the second half of this year. Our plan is to conduct two replicate three month efficacy studies which we anticipate will read out in 2016 and a single 12 months safety 3 study which we anticipate will readout in 2017. In total, we expect to randomize approximately 2,300 patients in the phase 3 program. As a reminder we are conducing and our partner Mylan is fully funding the phase 3 program. We are eligible to receive potential developments and commercialization milestone payments totaling $220 million. Next, let me comment briefly on our two 5HT4 receptor agonist development programs for gastrointestinal disorders. First we have Velusetrag an hourly does 5HT4 receptor agonist partnered with Alfa Wassermann in certain markets outside the U.S. The phase 2b study of Velusetrag in patients with gastroparesis is progressing and we look forward to the results of that study in 2016, Alfa Wassermann is funding the majority of this 2b study. Second we have TD-8954 a parentally…

Renee Gala

Analyst

Thank you, Mathai. Prior to reviewing the financial results, I'd like to remind you that the financial statements of Theravance Biopharma for periods prior to our sendoff in June, 2014 was derived from the historical consolidated financial statements of Theravance Inc. And therefore may not necessarily reflect what 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, revenue for the second quarter of 2015 totaled 7.1 million consisting of $5 million in VIBATIV related collaboration revenues and 2.1 million in net product sales of VIBATIV in the US. The collaboration revenue included a $3 million upfront payment from Cyclone Pharmaceuticals, resulting from a development and commercialization agreement for VIBATIV in China and a $2 million milestone payment from Rpharm related to marketing approval of VIBATIV in Russia. Our net product sales of VIBATIV is of 2.1 million reflect an increase of 66% over the first of 2015 and our cost to goods sold was $0.5 million in the second quarter. Research and development expenses for the second quarter was $30.4 million compared with $46.3 million for the same period in 2014. This equates to a year over year decrease of $15.9 million primarily due to lower costs associated with long term retention and incentive awards granted in 2011, and due to the reimbursement of costs and our TD 4208 program as a result of the Mylan collaboration. Share based compensation accounted for 6.8 million of the 30.4 million in R&D expense for the quarter. Selling, general and administrative expenses for the second quarter was 21.5 million compared with 13.1 million for the same period in 2014. The increase was primarily due to costs associated with VIBATIV commercialization and share based compensation. Of the 21.5…

Rick Winningham

Analyst

Thanks Renee. In summary we have a pipeline of high-value assets at various stages and commercialization and development. We remain confident in our strategy to establish VIBATIV is an important antibiotic in the treatment of serious infections globally and we are committed to see it realize its commercial potential. TD-4208 is progressing towards our registrational Phase 3 program in COPD. We have promising new differentiated therapeutics on major disease areas emerging from our research platform as Mathai delineated. We also have a number of programs in mid stage development that we consider to be partnerable assets. These include Velusetrag in the U.S., TD-8954, TD-6450 our HCV program in Axelopran and as well as the fix dose combination of Axelopran/Opioid, and TD-9855. We are having productive discussions with potential partners with many of these programs and look forward to making additional progress to beset position these assets for clinical and potentially commercial success. We have an exciting lineup of value generating near and mid-term milestones towards which we’re working including major data readouts. We expect four data readouts in 2016 including the Velusetrag Phase 2b study, two TD 4208 efficacy studies and the closed triple lung function study. Plus three additional data readouts in 2017 including the telavancin Phase 3 bacteremia study, the closed triple exacerbation study, and the TD-4208 long term safety study. In total six phase 3 studies, five of which were funded by partners and one Phase 2b study which is also funded largely by a partner. And we are excited to advance our early stage product candidates in targeting cardio vascular and renal disease, as well as ulcerative colitis with the goal of advancing both programs to phase-1 study in late 2015 or early 2016. As Mathai mentioned we’re in active discussions with a number potential partners for neprilysin inhibitor program. And finally our strong financial position and efficient corporate structure, we believe that we are well positioned for future value creation. And now I’d like to turn the call over to the operator for questions.

Operator

Operator

Okay thank you sir. [Operator Instructions].

Unidentified Analyst

Analyst

Unidentified Company Representative

Analyst

Operator

Operator

[Operator Instructions] It appears we have no questions in the queue. I’d like to turn it over to Mr. Winningham.

Rick Winningham

Analyst

Thank you very much operator and I’d like to thank everyone for participating in our call today and have a great day.

Operator

Operator

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