BioMarin Pharmaceutical Inc.’s (BMRN - Free Report) adjusted earnings of 25 cents per share beat the Zacks Consensus Estimate of 21 cents. In the year-ago quarter, the company had incurred loss of 6 cents per share.
Total revenues were $454.4 million in the reported quarter, up 29% from the year-ago period, driven by higher product revenues. Sales however missed the Zacks Consensus Estimate of $462 million.
BioMarin’s shares have declined 2.2% in the past year compared with the industry’s decrease of 8.8%.
Product revenues (including Aldurazyme) were $436.6 million in the fourth quarter, reflecting a 25.7% increase year over year. Product revenues from BioMarin's marketed brands (excluding Aldurazyme) grew 25% year over year to $412.7 million. Royalty and other revenues were $17.9 million in the quarter, higher than $6.0 million a year ago.
Its PKU franchise sales rose 28% year over year in the quarter to $154.3 million. Kuvan revenues rose 9% to $122.6 million driven by patient growth in North America.
Palynziq injection sales grossed $31.7 million in the quarter compared with $24.1 million in the previous quarter, driven by new patients initiating therapy as well as the growing number of patients who have now achieved once-daily dosing. The majority of Palynziq sales came from the United States.
Naglazyme sales rose 24% to $94.8 million mainly due to orders from Brazil.
Vimizim contributed $132.3 million to total revenues, up 16% year over year owing to patient growth in the United States and orders from Brazil.
Naglazyme and Vimzim revenues vary on a quarterly basis, primarily due to the timing of central government orders from some countries, mainly Brazil.
Brineura generated sales of $25.2 million in the fourth quarter, higher than $19.8 million reported in the previous quarter due to patient growth.
BioMarin received Aldurazyme royalties — totaling $25.2 million — from Genzyme, a subsidiary of Sanofi (SNY - Free Report) in the quarter, up 107% year over year.
R&D expenses rose 3.9% year over year to $155.5 million due to costs for pipeline development. Marketing expenses associated with Palynziq commercial efforts and launch preparations for valoctocogeneroxaparvovec or valrox resulted in 15.6% increase in SG&A expenses to $161.2 million.
Full-year 2019 sales rose 14% to $1.70 billion, slightly missing the Zacks Consensus Estimate of $1.71 billion. However, sales were within the guided range of $1.69-$1.72 billion.
Adjusted earnings of 93 cents per share beat the Zacks Consensus Estimate of $89 cents. Earnings rose 82% year over year.
BioMarin expects total revenues in 2020 to come in the range of $1.95-$2.05 billion which represents a growth of 17% at the middle of the range. Vimizim sales are expected in the range of $560-$610 million for the full year. Kuvan sales are projected within $430-$480 million. Naglazyme sales are predicted in the band of $380-$420 million. Brineura sales are expected within $85-$115 million. Palynziq sales are forecast in the $180-$210 million band.
R&D costs are expected to be within $675-$725 million. SG&A expenses are anticipated in the range of $780-$830 million.
The company expects adjusted net income in the range of $260-$310 million, the midpoint of which indicates growth of more than 70%.
BioMarin filed regulatory applications for valrox in U.S/EU in the fourth quarter, which were accepted and granted priority review by the FDA this month. The FDA is expected to give its decision on the same on Aug 21.
An important pipeline candidate is vosoritide, which is being developed to treat achondroplasia, the most common form of dwarfism. In December 2019, BioMarin announced positive top-line data from the phase III study evaluating vosoritide in children aged 5 to 14 with achondroplasia. Data showed that patients treated with the candidate achieved placebo-adjusted change from baseline in growth velocity of 1.6 cm/yr after treatment duration of one year. The company is planning to meet regulatory authorities in the first half of 2020 to discuss plans for submission of marketing applications for the candidate.