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BioMarin Announces First Quarter 2016 Financial Results

-First Quarter 2016 Total BioMarin Revenue Increases 16.7% Y/Y to $236.7 million

-Vimizim Net Product Revenue Increases 43.5% Y/Y and Contributes $72.6 million in the First Quarter 2016; Vimizim Full-year Revenue Guidance Increased to $315 to $340 million

- Kuvan Net Product Revenue Contributes $76.9 million in the First Quarter 2016; $60.0 million from North America and $16.9 million from Newly Acquired ex-North American Territories

Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)

Three Months Ended March 31,
2016 2015 % Change
Total BioMarin Revenue $ 236.7 $ 202.9 16.7 %
Vimizim Net Product Revenue 72.6 50.6 43.5 %
Naglazyme Net Product Revenue 65.4 78.2 (16.4 )%
Kuvan Net Product Revenue 76.9 50.2 53.2 %
Aldurazyme Net Product Revenue 16.4 18.2 (9.9 )%
Non-GAAP Net Loss $ (27.2 ) $ (25.4 )
GAAP Net Loss $ (85.1 ) $ (67.5 )
GAAP Net Loss per Share - Basic and Diluted $ (0.53 ) $ (0.43 )
Cash, cash equivalents and investments $ 771.3 $ 1,018.3

SAN RAFAEL, Calif., April 28, 2016 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. BMRN, -0.49% today announced financial results for the first quarter ended March 31, 2016. Non-GAAP net loss was $27.2 million for the quarter ended March 31, 2016, compared to non-GAAP net loss of $25.4 million for the first quarter of 2015. GAAP net loss was $85.1 million, or $0.53 per basic and diluted share for the first quarter of 2016, compared to GAAP net loss of $67.5 million, or $0.43 per basic and diluted share, for the first quarter of 2015.

Total BioMarin Revenue was $236.7 million for the first quarter of 2016, an increase of 16.7% compared to the same period in 2015. This strong result was driven by year over year growth of 43.5% and 53.2% of Vimizim and Kuvan, respectively. Kuvan revenue from ex-North America territories since BioMarin acquired worldwide rights in January 2016 contributed $16.9 million and revenues in North America contributed $60.0 million in the quarter. Naglazyme patient growth was 8.5% compared to a year ago, the 40 [th] straight quarter since the product was launched in 2005. Naglazyme revenue in the first quarter 2016 was lower than revenue in the first quarter 2015 primarily due to the timing of central government orders from Latin America.

As of March 31, 2016, BioMarin had cash, cash equivalents and investments totaling $771.3 million, as compared to $1,018.3 million on December 31, 2015.

Commenting on the quarter, Jean-Jacques Bienaim�, Chairman and Chief Executive Officer of BioMarin said, "Our commercial base business is robust and is expected to generate over one billion dollars in revenues this year. Prospects for new product launches in 2017 increased during the quarter due to positive data readouts for cerliponase alfa and pegvaliase that we expect will lead to two new product filings later this year. In addition, at our recent Research and Development Day for analysts and investors, we highlighted very encouraging preliminary data from our gene therapy product BMN 270 for hemophilia A and robust 12 month data with vosoritide for achondroplasia. If the data from these programs continue to mature as we hope, we believe that these products could each ultimately drive a billion dollars in revenue when commercialized. Finally, we continue to expect to manage this growing business with the goal of achieving non-GAAP break-even or better in 2017 regardless of the regulatory outcome of Kyndrisa in Europe."

Net Product Revenue (in millions of U.S. dollars, unaudited)

Total Revenue

Three Months Ended March 31,
2016 2015 $ Change % Change
Vimizim [ (1)] $ 72.6 $ 50.6 $ 22.0 43.5 %
Naglazyme [ (1)] 65.4 78.2 (12.8 ) (16.4 )%
Kuvan [(2)] 76.9 50.2 26.7 53.2 %
Aldurazyme 16.4 18.2 (1.8 ) (9.9 )%
Firdapse 4.1 4.1 - 0.0 %
Net product revenues 235.4 201.3 34.1 16.9 %
Collaborative agreement revenues 0.2 0.4 (0.2 )
Royalty, license and other revenues 1.1 1.2 (0.1 )
Total BioMarin revenues $ 236.7 $ 202.9 $ 33.8 16.7 %

[(1) ] Vimizim and Naglazyme revenues experience quarterly fluctuations primarily due to the timing of government ordering patterns in certain countries. The Company does not believe these fluctuations reflect a change in underlying demand.
[(2) ] Growth in North America contributed $60.0 million in the first quarter with an additional $16.9 million coming from newly acquired ex-North American territories.

Reconciliation of Aldurazyme Revenues

2016 2015 $ Change % Change
Aldurazyme revenue reported by Genzyme $ 52.8 $ 53.4 $ (0.6 ) (1.1 )%
Three Months Ended March 31,
2016 2015 $ Change
Royalties earned from Genzyme $ 21.5 $ 22.3 $ (0.8 )
Net product transfer revenues [ (3)] (5.1 ) (4.1 ) (1.0 )
Total Aldurazyme net product revenues $ 16.4 $ 18.2 $ (1.8 )

[(3) ] To the extent units shipped to third party customers by Genzyme exceed BioMarin inventory transfers to Genzyme, BioMarin will record a decrease in net product revenue from the royalty payable to BioMarin for the amount of previously recognized product transfer revenue. If BioMarin inventory transfers exceed units shipped to third party customers by Genzyme, BioMarin will record incremental net product transfer revenue for the period. Positive net product transfer revenues result in the period if BioMarin transferred more units to Genzyme than Genzyme sold to third-party customers.

2016 Financial Guidance

Revenue Guidance ($ in millions)

Item
ProvidedFebruary 25, 2016 Updated April 28, 2016
Total BioMarin Revenues $1,050 to $1,100 Unchanged
Vimizim Net Product Revenue $300 to $330 $315 to $340
Naglazyme Net Product Revenue $290 to $320 Unchanged
Kuvan Net Product Revenue $320 to $350 Unchanged

Select Income Statement Guidance ($ in millions, except percentages)

Item
Provided
February 25, 2016
Updated April 28, 2016
Cost of Sales (% of Total Revenue) 18.0% to 19.0% Unchanged
Selling, General and Admin. Expense $470 to $490 Unchanged
Research and Development Expense $680 to $720 Unchanged
Non - GAAP Net Loss $(75) to $(100) Unchanged
GAAP Net Loss $(400) to $(430) $(355) to $(385)*

*GAAP Net Loss guidance updated April 28, 2016 based on impact of final purchase accounting treatment for the PKU franchise acquisition from Merck that closed in the first quarter 2016.

Key Program Updates at R&D Day April 20, 2016

  • BMN 270 gene therapy product for hemophilia A: The Company provided encouraging preliminary data from an ongoing Phase 1/2 clinical trial with BMN 270, an investigational gene therapy treatment for hemophilia A. A total of eight patients with severe hemophilia A received a single dose of BMN 270, six of whom have been treated at the highest dose of 6 x 10 [13] vector genomes (VG)/kilogram (kg), and to date, post-treatment follow-up ranges from five to 16 weeks. As stated at R&D...

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