Total BioMarin Revenue Increased 37% to $751 million in 2014
Rolling Submission of NDA for Drisapersen Underway; Acquisition of Prosensa Complete
Financial Highlights ($ in millions, except per share data, unaudited)
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||
| 2014 | 2013 | % Change | 2014 | 2013 | % Change | |
| Total BioMarin Revenue | $ 230.9 | $ 146.9 | 57% | $ 751.0 | $ 548.5 | 37% |
| Vimizim Net Product Revenue | 36.9 | 0.1 | -- | 77.3 | 0.1 | -- |
| Naglazyme Net Product Revenue | 88.5 | 68.7 | 29% | 334.4 | 271.2 | 23% |
| Kuvan Net Product Revenue | 57.4 | 45.3 | 27% | 203.0 | 167.4 | 21% |
| Aldurazyme Net Product Revenue | 40.9 | 25.9 | 58% | 105.6 | 83.6 | 26% |
| Non-GAAP Net Loss | $ (11.4) | $ (15.8) | $ (25.9) | $ (40.4) | ||
| Non-GAAP Net Loss per Share - Basic | $ (0.08) | $ (0.11) | $ (0.18) | $ (0.29) | ||
| Non-GAAP Net Loss per Share - Diluted | $ (0.08) | $ (0.11) | $ (0.18) | $ (0.30) | ||
| GAAP Net Loss | $ (69.8) | $ (62.0) | $ (134.0) | $ (176.4) | ||
| GAAP Net Loss per Share - Basic | $ (0.47) | $ (0.43) | $ (0.92) | $ (1.28) | ||
| GAAP Net Loss per Share - Diluted | $ (0.47) | $ (0.44) | $ (0.92) | $ (1.28) | ||
| Cash, cash equivalents and investments | $ 1,043.1 | $ 1,052.4 | ||||
SAN RAFAEL, Calif., Feb. 25, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) today announced financial results for the fourth quarter and full year 2014, including full year revenues of $751.0 million, a 37% increase over 2013. For the quarter ended December 31, 2014, Non-GAAP net loss declined to $11.4 million ($0.08 per share, basic and diluted) for the fourth quarter of 2014, compared to non-GAAP net loss of $15.8 million ($0.11 per share, basic and diluted) for the fourth quarter of 2013. For the year ended December 31, 2014, non-GAAP net loss was reduced to $25.9 million ($0.18 per share, basic and diluted), compared to non-GAAP net loss of $40.4 million ($0.29 per share, basic and $0.30 per share diluted) for the year ended December 31, 2013.
GAAP net loss was $69.8 million ($0.47 per share, basic and diluted) for the fourth quarter of 2014, compared to GAAP net loss of $62.0 million ($0.43 per share basic and $0.44 per share diluted) for the fourth quarter of 2013. GAAP net loss for the year ended December 31, 2014 was $134.0 million ($0.92 per share, basic and diluted), compared to GAAP net loss of $176.4 million ($1.28 per share, basic and diluted) for the year ended December 31, 2013. As of December 31, 2014, BioMarin had cash, cash equivalents and investments totaling $1,043.1 million, as compared to $1,114.7 million on September 30, 2014.
"BioMarin delivered another year of strong results from our five commercialized products. Our accomplishments in 2014 have set the stage for a very productive 2015 both in terms of commercial success and clinical and regulatory milestones," said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "The acquisition of Prosensa in January 2015 adds exciting potential products to our rare disease portfolio. Importantly for shareholders, we believe the near-term approval of drisapersen in either the U.S. or Europe will drive us to profitability on a non-GAAP basis in 2017. Of even greater significance, we can now leverage our capabilities getting orphan-drugs approved for the benefit of boys with Duchenne Muscular Dystrophy, who currently have no approved treatment options."
Net Product Revenue
| Total Revenue Growth (in millions) | ||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2014 | 2013 | $ Change | % Change | 2014 | 2013 | $ Change | % Change | |
| Vimizim | $ 36.9 | $ 0.1 | $ 36.8 | -- | $ 77.3 | $ 0.1 | $ 77.2 | -- |
| Naglazyme | 88.5 | 68.7 | 19.8 | 29% | 334.4 | 271.2 | 63.2 | 23% |
| Kuvan | 57.4 | 45.3 | 12.1 | 27% | 203.0 | 167.4 | 35.6 | 21% |
| Aldurazyme | 40.9 | 25.9 | 15.0 | 58% | 105.6 | 83.6 | 22.0 | 26% |
| Firdapse | 4.1 | 4.3 | (0.2) | -5% | 18.1 | 16.1 | 2.0 | 12% |
| Net product revenue | 227.8 | 144.3 | 83.5 | 58% | 738.4 | 538.4 | 200.0 | 37% |
| Collaborative agreement revenue | 0.3 | 1.1 | (0.8) | 1.6 | 3.9 | (2.3) | ||
| Royalty and license revenue | 2.8 | 1.5 | 1.3 | 11.0 | 6.2 | 4.8 | ||
| Total BioMarin revenue | $ 230.9 | $ 146.9 | $ 84.0 | 57% | $ 751.0 | $ 548.5 | $ 202.5 | 37% |
| Reconciliation of Aldurazyme Revenues (in millions) | ||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2014 | 2013 | $ Change | % Change | 2014 | 2013 | $ Change | % Change | |
| Aldurazyme revenue reported by Genzyme | $ 56.3 | $ 59.5 | $ (3.2) | -5% | $ 228.8 | $ 212.4 | $ 16.4 | 8% |
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||
| 2014 | 2013 | $ Change | 2014 | 2013 | $ Change | |||
| Aldurazyme Royalties due from Genzyme - Non-GAAP (1) | $ 27.9 | $ 27.5 | $ 0.4 | $ 97.0 | $ 88.5 | $ 8.5 | ||
| Net product transfer revenue (2) | 13.0 | (1.6) | 14.6 | 8.6 | (4.9) | 13.5 | ||
| Total Aldurazyme net product revenue - GAAP | $ 40.9 | $ 25.9 | $ 15.0 | $ 105.6 | $ 83.6 | $ 22.0 | ||
| (1) See the "Non-GAAP Financial Information and Reconciliation" included in this press release, for a discussion of the GAAP to Non-GAAP adjustments and Management's use of Non-GAAP measures. | ||||||||
| (2) 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. | ||||||||
2015 Guidance
| Revenue Guidance ($ in millions) | |
| Item | 2015 Guidance |
| Total BioMarin Revenues | $840 to $870* |
| Vimizim Net Product Revenue | $170 to $200 |
| Naglazyme Net Product Revenue | $315 to $340 |
| Kuvan Net Product Revenue | $210 to $230 |
| * On a constant currency basis, Total BioMarin Revenues in 2015 would have been between $885 and $915 | |
| Selected Income Statement Guidance ($ in millions, except percentages) | |
| Item | 2015 Guidance |
| Cost of Sales (% of Total Revenue) | 17.0% to 18.0% |
| Selling, General and Admin. Expense | $360 to $395 |
| Research and Development Expense | $610 to $640 |
| Non - GAAP Net Loss | $(130) to $(170) |
| GAAP Net Loss | $(360) to $(400) |
Acquisition of Prosensa
With the acquisition of Prosensa completed this quarter, BioMarin added to its portfolio multiple orphan-drug candidates, including Prosensa's exon-skipping product candidate drisapersen for the treatment of Duchenne Muscular Dystrophy (DMD). Drisapersen has Orphan, Fast Track and Breakthrough Therapy designation and is currently under rolling review as part of a New Drug Application (NDA) with the Food and Drug Administration. Drisapersen, a potential first-to-market and best-in-class product for treating a large population of patients with a rare, fatal genetic disease represents up to 10,000 DMD patients. Follow-on products leverage the same technology platform and target an additional 35,000 DMD patients in BioMarin's commercial territories. All of the pipeline products added to BioMarin's portfolio through the acquisition leverage a proprietary RNA-modulating technology platform for the treatment of various genotypes of DMD and other genetic disorders. BioMarin expects to complete the NDA submission for drisapersen in April 2015.
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