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BioMarin Pharmaceutical: Biomarin Announces Third Quarter 2015 Financial Results And Company Update

The following excerpt is from the company's SEC filing.

- Vimizim Net Product Revenue $65 million in the Quarter; Vimizim Full-year Revenue Guidance Increased to $220 to $235 million

- Full-year Total BioMarin Revenue Guidance Increased to $880 million to $900 million

FDA Advisory Committee to Review Kyndrisa™ (drisapersen) November 24

for Treatment of Patients with Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping

Financial Highlights ($ in millions, except per share data, unaudited)

Three Months

Ended September 30,

Nine Months

% Change

Naglazyme Net Product Revenue

Kuvan Net Product Revenue

Aldurazyme Net Product Revenue

Non-GAAP Net Income (Loss)

(240.4

GAAP Net Income (Loss) per Share - Basic

GAAP Net Income (Loss) per Share - Diluted

Cash, cash equivalents and investments

1,132.7

1,043.1

SAN RAFAEL, Calif., October 29, 2015 – BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced financial results for the third quarter ended September 30, 2015. Non-GAAP net loss was $41.3 million for the third quarter of 2015, compared to non-GAAP net loss of $23.1 million for the third quarter of 2014. GAAP net loss was $90.9 million, or

($0.57) and ($0.60) per basic and diluted share, respectively, for the third quarter of 2015, compared to GAAP net income of $7.4 million, or $0.05 per basic and diluted share for the third quarter of 2014. The increased non-GAAP net loss was primarily due to increased operating expenses, partially offset by increased revenues due to the strong commercial launch of Vimizim. The increased GAAP net loss in the third quarter of 2015 compared to the same period last year was due primarily to the $67.5 million gain on the sale of the Priority Review Voucher BioMarin was awarded when Vimizim was approved.

Total BioMarin Revenue was $208.9 million for the third quarter of 2015 and $662.0 million for the first nine months of 2015, an increase of 18% and 28% respectively, compared to the same periods in 2014. These increases were driven by solid growth of Kuvan and the continued strong commercial launch of Vimizim. Kuvan Net Product Revenue in the third quarter increased 20% to $64.2 million driven primarily by patient count increases and high rates of compliance. Sales of Vimizim were recorded in 32 countries through the third quarter and totaled $65.1 million for the quarter. As anticipated, Naglazyme Net Product Revenue in the third quarter decreased quarter over quarter and was impacted by a large order in Latin America in the second quarter, consistent with historically uneven sales of the product in that region. Nevertheless, the number of new patients on commercial Naglazyme continued to increase globally, and the number of patients on Naglazyme commercial therapy at the end of the third quarter 2015 was approximately 9% greater than it was a year earlier at the end of the third quarter 2014. The strong dollar had a negative impact on current period and year to date total revenues. If exchange rates in 2015 had been unchanged from 2014, total revenues, net of the impact of our hedging programs, would have been approximately $10 million higher for the quarter and $38 million year to date.

Products impacted by foreign exchange rates include Vimizim and Naglazyme, as Kuvan is currently marketed solely in North America by BioMarin.

As of September 30, 2015, BioMarin had cash, cash equivalents and investments totaling $1,132.7 million, as compared to $1,043.1 million on December 31, 2014.

“BioMarin has been extremely productive over the last three months, with the start of our gene therapy clinical study in hemophilia A patients, the acquisition of the PKU franchise from Merck Serono and the sale of our talazoparib program to Medivation, Inc., just to name a few accomplishments,” said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. “On the regulatory front, we look forward to our meeting on November 24

with the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) to review the New Drug Application (NDA) for Kyndrisa. We continue to prepare for the potential near-term approval of Kyndrisa for the treatment of children with Duchenne muscular dystrophy, a devastating muscle wasting disease for which there is no approved therapy in the U.S.”

Mr. Bienaimé continued, “In September we launched our ‘

kNOWyourDuchenne’

program to help families and physicians obtain and interpret genetic testing for patients with Duchenne muscular dystrophy. BioMarin has over a decade of experience in tailoring support services based on individual need and we are grateful to have the opportunity to leverage our expertise for these families.”

Net Product Revenue (in millions, unaudited)

Total Revenue Growth

Three Months Ended September 30,

Nine Months Ended September 30,

$ Change

Firdapse

Net product revenues

Collaborative agreement revenues

Royalty, license and other revenues

Total BioMarin revenues

Vimizim and Naglazyme revenues experience quarterly fluctuations due to the timing of government ordering patterns in certain countries. The Company does not believe these fluctuations reflect a change in underlying demand.

Reconciliation of Aldurazyme Revenues

Aldurazyme revenue reported by Genzyme

Royalties earned from Genzyme

Net product transfer revenues

Total Aldurazyme net product revenues

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 Updated

Revenue Guidance ($ in millions)

Provided

Total BioMarin Revenues

$850 to $880

$880 to $900*

$200 to $220

$315 to $340

$300 to $310

$210 to $230

$235 to $245

If exchange rates in 2015 remained unchanged from 2014, Total BioMarin Revenue Guidance for 2015 would be between $40 to $50 million higher.

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

Provided

Cost of Sales (% of Total Revenue)

17.0% to 18.0%

Unchanged

Selling, General and Admin. Expense

$360 to $395

$400 to $410

Research and Development Expense

$610 to $640

Non - GAAP Net Loss

$(130) to $(170)

$(115) to $(135)

GAAP Net Loss**

$(360) to $(400)

$(85) to $(105)

** The change in GAAP Net Loss guidance is primarily due to the estimated net gain from the sale of intangible assets of the talazoparib program to Medivation in Q4 2015. The estimated net gain will be included in Operating Expenses under the caption “Gain on sale of intangible assets.”

Anticipated

Milestones over the Next 6-months

Kyndrisa (drisapersen) for Duchenne muscular dystrophy:

The Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the New Drug Application (NDA) for Kyndrisa on November 24, 2015. The PDUFA date for Kyndrisa is December 27, 2015.

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