Theravance Biopharma(US:TBPH)2023-08-09 10:16Financial Performance - YUPELRI net sales for the three months ended June 30, 2023, were $55.0 million, a 12% increase from $49.1 million in the same period of 2022, and for the six months ended June 30, 2023, net sales were $102.0 million, a 10% increase from $92.7 million in 2022[98]. - For the three months ended June 30, 2023, YUPELRI net sales (implied 35%) were $19.3 million, a 12% increase from the prior year, while total revenue increased by 24% to $13.7 million[117][119]. - Collaboration revenue from Viatris increased by 26% for the three months ended June 30, 2023, driven by increased net sales of YUPELRI[119]. - TRELEGY's global net sales increased from $661.4 million in 2019 to $2.1 billion in 2022, with expected peak annual sales of $3.7 billion according to consensus estimates[112]. Capital Return Program - The capital return program was increased to $325.0 million, with $135.6 million spent on repurchasing 12.44 million shares at an average cost of $10.90 per share for the six months ended June 30, 2023[90]. - The capital return program was increased by $75.0 million to a total of $325.0 million, with $135.6 million spent on share repurchases during the six months ended June 30, 2023[139]. Expenses and Restructuring - The company incurred restructuring expenses of $2.7 million related to the discontinuation of research activities, with cash-related expenses of $1.2 million and non-cash expenses of $1.5 million[90]. - R&D expenses decreased by 37% to $9.4 million for the three months ended June 30, 2023, compared to the prior year, primarily due to strategic actions and corporate restructuring[121]. - Selling, general and administrative expenses increased by $3.1 million (19%) and $4.4 million (13%) for the three and six months ended June 30, 2023, respectively, primarily due to external-related expenses[124]. - Restructuring and related expenses decreased by $1.8 million (61%) and $9.6 million (78%) for the three and six months ended June 30, 2023, respectively, compared to the prior year periods[127]. Cash Flow and Financial Position - As of June 30, 2023, the company had approximately $167.5 million in cash, cash equivalents, and investments in marketable securities, with no long-term debt[138]. - Net cash used in operating activities was $23.7 million for the six months ended June 30, 2023, an improvement of $17.1 million compared to the prior year[142]. - Net cash used in financing activities was $136.9 million for the six months ended June 30, 2023, primarily due to share repurchases[147]. - The company expects its cash resources to be sufficient to fund operations and the capital return program for at least the next twelve months[141]. Clinical Development and Partnerships - Ampreloxetine is in a Phase 3 clinical study for symptomatic neurogenic orthostatic hypotension (nOH) in patients with Multiple System Atrophy (MSA), with the FDA granting Orphan Drug Designation status in May 2023[104]. - The Phase 4 study of YUPELRI is aimed at comparing lung function improvements in COPD patients, with the company agreeing to pay 35% of the study costs[97]. - The company plans to seek a partnership to continue the progression of its inhaled JAK inhibitor program after discontinuing investment in research activities[90]. - Viatris is responsible for the commercialization of YUPELRI outside the US, with a profit-sharing arrangement of 65% to Viatris and 35% to the company[92]. Licensing and Royalties - The company recognized no licensing revenue for the three months ended June 30, 2023, following the termination of the Pfizer agreement[120]. - Royalty Pharma invested up to $40.0 million in ampreloxetine, with a $25.0 million upfront payment and a $15.0 million payment upon regulatory approval, receiving future royalties of 2.5% on sales up to $500.0 million and 4.5% on sales over that amount[105]. - The first milestone payment of $50.0 million from Royalty Pharma will be triggered if GSK receives $240.0 million or more in royalty payments from TRELEGY global net sales, expected if sales reach approximately $2.863 billion[109]. - The company expects to receive 85% of the royalty payments on TRELEGY from Royalty Pharma for sales occurring after January 1, 2031, and July 1, 2029, for US and ex-US sales, respectively[110]. Share-Based Compensation - For the three months ended June 30, 2023, the company did not grant any market-based RSUs, while for the six months, it granted 165,000 RSUs with a fair value of $1.4 million[150]. - The fair value of the market-based RSUs is being recognized through February 2027, with $0.2 million and $0.3 million recognized as share-based compensation expense for the three and six months ended June 30, 2023, respectively[152]. - The company did not grant any performance-contingent RSUs for the three months ended June 30, 2023, but granted 367,000 RSUs with a fair value of $3.7 million for the six months, with performance vesting dates through February 2026[153]. - As of June 30, 2023, the company concluded that the achievement of performance vesting criteria for the performance-contingent RSUs was not probable, resulting in no expense being recognized for these awards[153]. Market Risks - The company indicated that its market risks as of June 30, 2023, have not changed materially from those discussed in its Annual Report on Form 10-K for the year ended December 31, 2022[154].