BioMarin Pharmaceutical(US:BMRN)2022-08-04 17:56Financial Performance - Total revenues for the three months ended June 30, 2022, were $533.8 million, compared to $501.7 million for the same period in 2021, representing a growth of 6.2%[115] - Net income for the six months ended June 30, 2022, was $148.5 million, significantly higher than $30.3 million for the same period in 2021, indicating a year-over-year increase of 388.5%[115] - Total net product revenues for the three months ended June 30, 2022, were $517.7 million, an increase of $31.0 million (6.4%) compared to $486.7 million for the same period in 2021[140] - The increase in net product revenues for the six months ended June 30, 2022, was primarily attributed to new patients initiating therapy for Voxzogo, Vimizim, and Naglazyme[134] Sales and Market Developments - Voxzogo's global launch is underway, with an increase in the number of children treated and active markets contributing to sales as of June 30, 2022[117] - Marketing authorization for Voxzogo was approved in Japan and Australia, with commercial sales expected to begin in Q3 2022[118] - Voxzogo contributed $34.4 million in sales for the three months ended June 30, 2022, driven by new patients initiating therapy in Europe and the U.S.[133] - Brineura sales increased by $7.4 million (24.4%) to $37.7 million for the three months ended June 30, 2022, primarily due to new patient initiations[140] - Kuvan sales decreased by $21.2 million (26.9%) to $57.6 million for the three months ended June 30, 2022, attributed to generic competition following the loss of exclusivity in the U.S.[133] Research and Development - The company plans to resubmit the Biologics License Application for valoctocogene roxaparvovec by the end of September 2022, anticipating a six-month review process[123] - The Phase 3b study for valoctocogene roxaparvovec has completed enrollment and is expected to read out in early 2023[125] - BMN 255 for primary hyperoxaluria type 1 has received FDA permission to proceed with the multiple ascending dose portion of its First-in-Human study[125] - R&D expense for the three months ended June 30, 2022 was $158.2 million, a decrease of $2.9 million compared to $161.1 million for the same period in 2021[151] - R&D expense for the six months ended June 30, 2022 increased to $319.0 million, up $9.2 million from $309.8 million in the prior year[151] - The company expects R&D expenses to increase in future periods due to heightened activities in research and early development programs[153] Operating Expenses - SG&A expenses for the three months ended June 30, 2022 totaled $196.8 million, an increase of $12.6 million from $184.2 million in the same period of 2021[155] - SG&A expenses for the six months ended June 30, 2022 were $391.5 million, reflecting a $33.0 million increase compared to $358.5 million in the prior year[155] - The company anticipates SG&A expenses to rise as it prepares to launch new products and support global business growth[159] Cash Flow and Liquidity - As of June 30, 2022, cash and cash equivalents increased to $619.8 million from $587.3 million as of December 31, 2021, a change of $32.5 million[169] - Net cash provided by operating activities decreased to $10.8 million for the six months ended June 30, 2022, down from $196.3 million in the same period of 2021, a change of $(185.5) million[171] - Net cash provided by investing activities increased to $58.1 million for the six months ended June 30, 2022, compared to $(191.0) million in the same period of 2021, a change of $249.1 million[172] - The company believes cash generated from sales and current investments will satisfy liquidity requirements for at least the next 12 months[169] - The company may need to raise additional funds for future operations, including the commercialization of products and potential acquisitions[169] Tax and Interest - Interest income for the three months ended June 30, 2022 was $2.5 million, down $2.0 million from $4.5 million in the same period of 2021[164] - Interest income for the six months ended June 30, 2022 decreased to $4.3 million, a decline of $2.6 million compared to $6.9 million in the prior year[164] - Provision for income taxes for the three months ended June 30, 2022 was $7.2 million, an increase of $1.2 million from the previous year[167] - Provision for income taxes for the six months ended June 30, 2022 was $20.6 million, up $13.5 million compared to $7.1 million in the same period of 2021[167] Market Conditions - The ongoing COVID-19 pandemic continues to impact business operations, with demand interruptions and delayed treatments affecting financial results[116] - The unfavorable impact of foreign currency exchange rates on product sales for the three months ended June 30, 2022, was $13.7 million compared to a favorable impact of $5.5 million in the same period of 2021[139] - The company anticipates continued adverse effects on market share and revenues due to the loss of exclusivity for Kuvan and the ongoing impact of the COVID-19 pandemic[133] - The company is monitoring macroeconomic conditions that could affect customer payment capabilities in economically volatile countries[170]