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Financial Highlights ($ in millions, except per share data, unaudited)
Item | Q2 2012 | Q2 2011 | Percent Change |
Total BioMarin Revenue | $ 124.0 | $ 110.6 | 12.1% |
Total Net Product Revenue | 123.0 | 109.6 | 12.2% |
Naglayzme Net Product Revenue* | 62.9 | 60.3 | 4.3% |
Aldurazyme BioMarin Net Product Revenue | 21.8 | 17.3 | 26.0% |
Kuvan Net Product Revenue | 34.7 | 28.8 | 20.5% |
Firdapse Net Product Revenue | 3.6 | 3.2 | 12.5% |
GAAP Net Loss | (32.0) | (5.1) | |
GAAP Net Loss per Share (basic and diluted) | $ (0.27) | $ (0.05) | |
Non-GAAP Adjusted EBITDA Income (Loss) | (7.3) | 13.9 | |
* Naglazyme net product revenue for the second quarter of 2012 compared to the second quarter of 2011 was negatively impacted by $1.0 million (or 2.5% of sales) due to changes in foreign currency exchange rates, net of hedges, and was also affected by the timing of government ordering patterns. Naglazyme net product revenue for the first half of 2012 has increased by approximately 9% compared to the first half of 2011, which is proportionate to the number of new patients that initiated commercial therapy over the last year. |
GAAP net loss for the six months ended
As of
"Our commercial portfolio continued to perform well in the second quarter, and revenue generated from our products is helping to fund a large portion of our pipeline programs," said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "The successful and timely execution of our R&D pipeline remains our top priority as we look forward to several key clinical program readouts in the coming months. In addition to the results of the Phase 3 GALNS trial, we also expect to have results from three Phase 2 programs - PEG-PAL for PKU, BMN-701 for Pompe disease, and BMN-673 for solid tumors."
Net Product Revenue (in millions)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2012 | 2011 | $ Change | % Change | 2012 | 2011 | $ Change | % Change | |
Naglazyme (1) | $ 62.9 | $ 60.3 | $ 2.6 | 4.3% | $ 131.5 | $ 120.9 | $ 10.6 | 8.8% |
Kuvan (2) | 34.7 | 28.8 | 5.9 | 20.5% | 66.7 | 55.5 | 11.2 | 20.2% |
Firdapse (3) | 3.6 | 3.2 | 0.4 | 12.5% | 7.2 | 6.3 | 0.9 | 14.3% |
(1) Changes in foreign currency rates, net of hedges, had a negative
(2) The quantity of commercial tablets dispensed to patients in the U.S. increased 16.9 percent in the second quarter of 2012 compared to the second quarter of 2011.
(3) A product for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS) which was launched in the EU in
Three Months Ended June 30, | Six Months Ended June 30, | |||||||
2012 | 2011 | $ Change | % Change | 2012 | 2011 | $ Change | % Change | |
Aldurazyme revenue reported by Genzyme (4) | $ 45.8 | $ 44.5 | $ 1.3 | 2.9% | $ 91.7 | $ 87.2 | $ 4.5 | 5.2% |
Royalties due from Genzyme | 18.4 | 17.3 | 1.1 | 36.8 | 34.0 | 2.8 | ||
Incremental product transfer revenues (5) | 3.4 | -- | 3.4 | (3.0) | 2.0 | (5.0) | ||
Total Aldurazyme net product revenues | $ 21.8 | $ 17.3 | $ 4.5 | $ 33.8 | $ 36.0 | $ (2.2) |
(4) The total number of Aldurazyme patients increased 8.0 percent in the second quarter of 2012 as compared to the second quarter of 2011.
(5) 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.
2012 Guidance
Revenue Guidance ($ in millions) | ||
Item | 2012 Guidance | Previous 2012 Guidance |
Total BioMarin Revenues | Unchanged | $475 to $510 |
Total Net Product Revenues | Unchanged | $470 to $505 |
Naglazyme Net Product Revenue | Unchanged | $250 to $265 |
Kuvan Net Product Revenue | $130 to $140 | $126 to $136 |
Aldurazyme Net Product Revenue to BioMarin | Unchanged | $81 to $87 |
Firdapse Net Product Revenue | Unchanged | $13 to $17 |
Selected Income Statement Guidance ($ in millions) | ||
Item | 2012 Guidance | Previous 2012 Guidance |
Cost of Sales (% of Total Revenue) | Unchanged | 17% to 18% |
Selling, General and Admin. Expense | Unchanged | $195 to $205 |
Research and Development Expense | $285 to $295 | $265 to $275 |
Amortization and Contingent Consideration | Unchanged | $19 |
Income Tax Expense | Unchanged | $ -- |
GAAP Net (Loss) | $(115) to (105) | $(92) to $(82) |
Stock Compensation Expense | $50 | $46 |
Non-GAAP Adjusted EBITDA | $(5) to $5 | $15 to $25 |
Non GAAP Net Cash Flow (Usage) | $(40) to $(50) | $(30) to $(40) |
Cash Balance* | $475 to $485 | $250 to $260 |
* Cash balance includes cash, cash equivalents and short and long term investments |
Anticipated Upcoming Milestones
3Q 2012: | Results for Phase II trial for PEG-PAL for PKU |
3Q 2012: | Results for Phase I trial for BMN-111 for achondroplasia in healthy volunteers |
4Q 2012: | Results for Phase III trial for GALNS for MPS IVA |
4Q 2012: | Results for Phase I/II trial for BMN-673 for solid tumors |
1Q 2013: | Market authorization application filing for GALNS for MPS IVA |
1Q 2013: | Results for Phase I/II trial for BMN-701 for Pompe disease |
1H 2013: | IND filing for BMN-190 for LINCL (Batten disease) |
2Q 2013: | Potential initiation of Phase III trial for PEG-PAL for PKU |
2Q 2013: | Results for PKU-016 Kuvan neurocognitive study |
2H 2013: | Potential initiation of Phase III trial for BMN-673 for solid tumors |
4Q 2013: | Potential FDA approval of GALNS for MPS IVA |
Research and Development Programs
BioMarin continues to make significant investments in research and development to ensure a strong and profitable pipeline for the company. The current pipeline includes programs in various stages of development that focus on treating a range of rare and serious unmet medical needs.
Advanced Clinical Programs
Mid-Stage Clinical Programs
Early-Stage Clinical Programs
Preclinical Programs
Non-GAAP Financial Information and Reconciliation
The above results for the three and six months ended
The following table presents the reconciliation of non-GAAP to GAAP financial metrics:
Reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA Income (Loss) | |||||
(in millions) | |||||
(unaudited) | |||||
Three Months Ended June 30, |
Six Months Ended June 30, |
||||
NOTES | 2012 | 2011 | 2012 | 2011 | |
GAAP Net Loss | $ (32.0) | $ (5.1) | $ (56.0) | $ (9.4) | |
Interest expense, net | 1.4 | 1.3 | 2.8 | 2.6 | |
Income tax expense (benefit) | (0.4) | 3.9 | (0.4) | 8.7 | |
Depreciation | 7.2 | 6.3 | 14.5 | 12.7 | |
Amortization | 2.7 | 1.0 | 12.0 | 1.9 | |
EBITDA Income (Loss) | (21.1) | 7.4 | (27.1) | 16.5 | |
Stock-based compensation | 12.6 | 10.6 | 23.8 | 21.0 | |
Contingent consideration | (1) | 1.2 | (4.1) | (3.9) | (4.6) |
Non-GAAP Adjusted EBITDA Income (Loss) | $ (7.3) | $ 13.9 | $ (7.2) | $ 32.9 | |
(1) Represents the changes in the fair value of contingent acquisition consideration payable for the period. The change in the current quarter reflects changes in estimated probabilities and timing of achieving certain developmental milestones. |
BioMarin believes that this non-GAAP information is useful to investors, taken in conjunction with BioMarin's GAAP information because it provides additional information regarding the performance of BioMarin's core ongoing business, Naglazyme, Kuvan, Aldurazyme and Firdapse and development of its pipeline. By providing information about both the overall GAAP financial performance and the non-GAAP measures that focus on continuing operations, the company believes that the additional information enhances investors' overall understanding of the company's business and prospects for the future. Further, the company uses both the GAAP and the non-GAAP results and expectations internally for its operating, budgeting and financial planning purposes and uses the Non-GAAP Adjusted EBITDA methodology in establishing corporate goals for internal compensation programs.
Conference Call Details
BioMarin will host a conference call and webcast to discuss second quarter 2012 financial results today,
Date: August 1, 2012 |
Time: 5:00 p.m. ET |
U.S. / Canada Dial-in Number: 800.299.7089 |
International Dial-in Number: 617.801.9714 |
Participant Code: 93633766 |
Replay Dial-in Number: 888.286.8010 |
Replay International Dial-in Number: 617.801.6888 |
Replay Code: 76241046 |
About BioMarin
BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions. The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates. Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with
The
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of
BioMarin®, Naglazyme®, Kuvan® and Firdapse™ are registered trademarks of
Aldurazyme® is a registered trademark of
BIOMARIN PHARMACEUTICAL INC. | ||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
June 30, 2012 and December 31, 2011 | ||
(In thousands of U.S. dollars, except share and per share amounts) | ||
June 30, | December 31, | |
2012 | 2011(1) | |
ASSETS | (unaudited) | |
Current assets: | ||
Cash and cash equivalents | $ 177,757 | $ 46,272 |
Short-term investments | 224,829 | 148,820 |
Accounts receivable, net (allowance for doubtful accounts: $471 and $513, respectively) | 100,750 | 104,839 |
Inventory | 120,125 | 130,118 |
Other current assets | 58,073 | 39,753 |
Total current assets | 681,534 | 469,802 |
Investment in BioMarin/Genzyme LLC | 1,185 | 559 |
Long-term investments | 121,970 | 94,385 |
Property, plant and equipment, net | 267,374 | 268,971 |
Intangible assets, net | 168,267 | 180,277 |
Goodwill | 51,543 | 51,543 |
Long-term deferred tax assets | 220,593 | 222,649 |
Other assets | 20,061 | 15,495 |
Total assets | $ 1,532,527 | $ 1,303,681 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||
Current liabilities: | ||
Accounts payable and accrued liabilities | $ 96,557 | $ 94,125 |
Convertible debt | 23,440 | -- |
Total current liabilities | 119,997 | 94,125 |
Long-term convertible debt | 324,865 | 348,329 |
Other long-term liabilities | 87,239 | 88,179 |
Total liabilities | 532,101 | 530,633 |
Stockholders' equity: | ||
Common stock, $0.001 par value: 250,000,000 shares authorized at June 30, 2012 and December 31, 2011: 123,235,882 and 114,789,732 shares issued and outstanding at June 30, 2012 and December 31, 2011, respectively. | 123 | 115 |
Additional paid-in capital | 1,483,336 | 1,197,082 |
Company common stock held by Nonqualified Deferred Compensation Plan | (6,604) | (3,935) |
Accumulated other comprehensive income | 4,650 | 4,887 |
Accumulated deficit | (481,079) | (425,101) |
Total stockholders' equity | 1,000,426 | 773,048 |
Total liabilities and stockholders' equity | $ 1,532,527 | $ 1,303,681 |
(1) December 31, 2011 balances were derived from the audited consolidated financial statements. | ||
BIOMARIN PHARMACEUTICAL INC. | ||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Three and Six Months Ended June 30, 2012 and 2011 | ||||
(In thousands of U.S. dollars, except per share amounts) | ||||
(Unaudited) | ||||
Three Months Ended June 30, | Six Months Ended June 30, | |||
2012 | 2011 | 2012 | 2011 | |
REVENUES: | ||||
Net product revenues | $ 122,991 | $ 109,616 | $ 239,230 | $ 218,692 |
Collaborative agreement revenues | 423 | 153 | 519 | 278 |
Royalty and license revenues | 605 | 862 | 919 | 1,117 |
Total revenues | 124,019 | 110,631 | 240,668 | 220,087 |
OPERATING EXPENSES: | ||||
Cost of sales (excludes amortization of certain acquired intangible assets) | 23,574 | 19,263 | 40,679 | 40,059 |
Research and development | 77,812 | 52,909 | 151,646 | 97,889 |
Selling, general and administrative | 51,539 | 41,015 | 96,787 | 82,089 |
Intangible asset amortization and contingent consideration | 2,048 | (3,324) | 4,376 | (3,012) |
Total operating expenses | 154,973 | 109,863 | 293,488 | 217,025 |
INCOME (LOSS) FROM OPERATIONS | (30,954) | 768 | (52,820) | 3,062 |
Equity in the income (loss) of BioMarin/Genzyme LLC | 102 | (667) | (632) | (1,209) |
Interest income | 536 | 798 | 1,041 | 1,580 |
Interest expense | (1,925) | (2,201) | (3,872) | (4,364) |
Other income and (expense) | (176) | 129 | (140) | 151 |
INCOME (LOSS) BEFORE INCOME TAXES | (32,417) | (1,173) | (56,423) | (780) |
Provision for (benefit from) income taxes | (411) | 3,904 | (445) | 8,668 |
NET LOSS | $ (32,006) | $ (5,077) | $ (55,978) | $ (9,448) |
NET LOSS PER SHARE, BASIC AND DILUTED | $ (0.27) | $ (0.05) | $ (0.48) | $ (0.09) |
Weighted average common shares outstanding, basic and diluted | 117,912 | 111,114 | 116,496 | 110,884 |
COMPREHENSIVE LOSS | $ (29,868) | $ (5,213) | $ (56,215) | $ (15,559) |
STOCK-BASED COMPENSATION EXPENSE | ||||
Total stock-based compensation expense included in the Condensed Consolidated Statements of Comprehensive Loss is as follows: | ||||
Three Months Ended | Six Months Ended | |||
June 30, | June 30, | |||
2012 | 2011 | 2012 | 2011 | |
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |
Cost of sales | $ 1,335 | $ 1,127 | $ 2,207 | $ 2,529 |
Research and development | 5,468 | 4,024 | 10,290 | 7,698 |
Selling, general and administrative | 5,834 | 5,456 | 11,268 | 10,760 |
$ 12,637 | $ 10,607 | $ 23,765 | $ 20,987 |
CONTACT: InvestorsEugenia Shen BioMarin Pharmaceutical Inc. (415) 506-6570 MediaBob Purcell BioMarin Pharmaceutical Inc. (415) 506-3267
BioMarin Pharmaceutical Inc.