United Therapeutics Reports Second Quarter 2017 Financial Results
SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., July 27, 2017 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced its financial results for the second quarter ended June 30, 2017.
"Our second quarter total net revenues reached $445 million, our highest quarterly net revenue level ever," said Martine Rothblatt, Ph.D., United Therapeutics Chairman and Chief Executive Officer. "We continue to believe that Orenitram is well-positioned given the large and growing number of pulmonary arterial hypertension (PAH) patients in need of a true prostacyclin analogue therapy following their use of other oral therapies, and we think we are beginning to see the early signs of this transition reflected in Orenitram's 21% growth in second quarter net revenues as compared to the second quarter of 2016. We are also advancing a growing number of pipeline priorities such as our new chemical entity esuberaprost, which has fully enrolled its phase III BEAT study, our phase III studies of new indications related to pulmonary fibrosis and heart failure, and our new organ manufacturing technologies, since lung transplantation is currently the only curative treatment for PAH."
Key financial highlights include (dollars in millions, except per share data):
Three Months Ended | Percentage | ||||||||
2017 | 2016 | Changes | |||||||
Revenues | $ | 444.6 | $ | 412.6 | 8 | % | |||
Net (loss) income | $ | (56.0) | $ | 206.1 | (127) | % | |||
Non-GAAP earnings(1) | $ | 199.2 | $ | 207.2 | (4) | % | |||
Net (loss) income, per diluted share | $ | (1.25) | $ | 4.39 | (128) | % | |||
Non-GAAP earnings, per diluted share(1) | $ | 4.37 | $ | 4.42 | (1) | % | |||
(1) See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below. |
Financial Results for the Three Months Ended June 30, 2017 compared to the Three Months Ended June 30, 2016
Revenues
The following table presents the components of total revenues (dollars in millions):
Three Months Ended | Percentage | ||||||||
2017 | 2016 | Change | |||||||
Net product sales: | |||||||||
Remodulin® | $ | 157.7 | $ | 158.9 | (1) | % | |||
Tyvaso® | 104.2 | 107.0 | (3) | % | |||||
Adcirca® | 120.6 | 90.9 | 33 | % | |||||
Orenitram® | 46.0 | 38.0 | 21 | % | |||||
Unituxin® | 16.1 | 17.8 | (10) | % | |||||
Total revenues | $ | 444.6 | $ | 412.6 | 8 | % | |||
Revenues for the three months ended June 30, 2017 increased by $32.0 million compared to the same period in 2016. The growth in revenues resulted from the following: (1) a $29.7 million increase in Adcirca net product sales; and (2) an $8.0 million increase in Orenitram net product sales. These increases were partially offset by a $2.8 million decrease in Tyvaso net product sales, a $1.7 million decrease in Unituxin net product sales, and a $1.2 million decrease in Remodulin net product sales.
Expenses
Cost of product sales. The table below summarizes cost of product sales by major category (dollars in millions):
Three Months Ended | Percentage | ||||||||
2017 | 2016 | Change | |||||||
Category: | |||||||||
Cost of product sales, excluding share-based compensation | $ | 19.3 | $ | 20.0 | (4) | % | |||
Share-based compensation benefit(1) | (0.4) | n/a | |||||||
Total cost of product sales | $ | 18.9 | $ | 20.0 | (6) | % | |||
(1) Refer to Share-based compensation (benefit) expense below for discussion. |
Research and development expense. The table below summarizes research and development expense by major category (dollars in millions):
Three Months Ended | Percentage | ||||||||
2017 | 2016 | Change | |||||||
Category: | |||||||||
Research and development, excluding share-based compensation | $ | 61.6 | $ | 37.0 | 66 | % | |||
Share-based compensation benefit(1) | (1.8) | (1.8) | 0 | % | |||||
Total research and development expense | $ | 59.8 | $ | 35.2 | 70 | % | |||
(1) Refer to Share-based compensation (benefit) expense below for discussion. |
Research and development, excluding share-based compensation. The increase in research and development expense of $24.6 million for the three months ended June 30, 2017, as compared to the same period in 2016, was driven by the expansion of our pipeline programs to treat cardiopulmonary diseases and cancer and to develop technologies in organ manufacturing. Research and development expense for the treatment of cardiopulmonary diseases increased by $8.5 million for the three months ended June 30, 2017, as compared to the same period in 2016, due to increased spending on several clinical and non-clinical studies, including FREEDOM-EV, INCREASE and SOUTHPAW, and the development of new drug delivery devices. Research and development expenses for cancer-related projects increased by $6.9 million for the three months ended June 30, 2017, as compared to the same period in 2016, driven by an increase in spending on clinical studies of dinutuximab in adult patients with small cell lung cancer. Research and development expenses for our organ manufacturing projects increased by $9.3 million for the three months ended June 30, 2017, as compared to the same period in 2016, due to increases in preclinical work on technologies designed to increase the supply and distribution of transplantable organs and tissues.
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