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BioMarin Announces Second Quarter 2021 Financial Results and Corporate Updates Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended June 30, Six Months Ended June 30, 2021 2020...

Key Takeaway: SAN RAFAEL, Calif. , July 28, 2021 /PRNewswire/ -- Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the second quarter ended June 30,

Full Press Release Details

SAN RAFAEL, Calif. , July 28, 2021 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 % Change 2021 2020 % Change
Total Revenues $ 501.7 $ 429.5 17 % $ 987.7 $ 931.6 6 %
Net Product Revenues Marketed by BioMarin (1) $ 458.6 $ 386.8 19 % $ 876.3 $ 820.1 7 %
Vimizim Net Product Revenues $ 171.7 $ 116.7 47 % $ 329.9 $ 253.9 30 %
Naglazyme Net Product Revenues $ 118.8 $ 81.0 47 % $ 226.1 $ 195.3 16 %
Kuvan Net Product Revenues $ 78.8 $ 122.6 (36) % $ 149.6 $ 244.6 (39) %
Palynziq Net Product Revenues $ 59.0 $ 40.7 45 % $ 113.0 $ 75.3 50 %
Brineura Net Product Revenues $ 30.3 $ 25.8 17 % $ 57.7 $ 49.8 16 %
Aldurazyme Net Product Revenues $ 28.1 $ 32.3 (13) % $ 78.1 $ 88.0 (11) %
GAAP Net Income (Loss) $ 12.9 $ (29.2) $ 30.3 $ 52.2
GAAP Net Income (Loss) per Share – Basic $ 0.07 $ (0.16) $ 0.17 $ 0.29
GAAP Net Income (Loss) per Share – Diluted $ 0.07 $ (0.16) $ 0.16 $ 0.28
Non-GAAP Income (2) $ 97.8 $ 57.4 $ 202.1 $ 173.9
June 30, 2021 December 31, 2020
Cash, cash equivalents and investments $ 1,473.6 $ 1,350.9
(1) Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Kuvan, Naglazyme, Palynziq, Brineura for the three and six months ended June 30, 2021 and includes Firdapse for the six months ended June 30, 2020, each calculated in accordance with Generally Accepted Accounting Principles in the United States (U.S. GAAP). Sanofi Genzyme (Genzyme) is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Refer to page 10 for a table showing Net Product Revenues by product. In January 2020, BioMarin divested the Firdapse assets to a third party in a sale transaction. The sale is reflected in the Company's consolidated financial statements for the first quarter ended March 31, 2020; as a result of the transaction BioMarin no longer recognizes Net Product Revenues from Firdapse.
(2) Non-GAAP Income is defined by the Company as reported GAAP Net Income/Loss, excluding net interest expense, provision for (benefit from) income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and, in certain periods, certain other specified items. Refer to Non-GAAP Information beginning on page 11 of this press release for a complete discussion of the Company's Non-GAAP financial information and reconciliations to the comparable information reported under U.S. GAAP.
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the second quarter ended June 30, 2021.
"We enjoyed a strong first half of 2021, including financial results and the achievement of our key regulatory goals," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "With the positive CHMP opinion for VOXZOGO for children, 2 years of age and older, our commercial team is eagerly preparing for potential European approval and launch later this summer. If approved, VOXZOGO would be the first pharmacological treatment option for children with achondroplasia. Following potential approval in Europe later this summer, we hope to have a positive outcome in the United States pending our November 20 PDUFA target action date. Upon potential global approvals of VOXZOGO for achondroplasia, we have a tremendous opportunity to address the interest from families seeking treatment for their children."
Mr. Bienaimé continued, "We were pleased to receive validation of our MAA in Europe for valoctocogene roxaparvovec for the treatment of severe hemophilia A, paving the way for a CHMP opinion in the first half of 2022. Our data presentations at the International Society on Thrombosis and Haemostasis in July provided further evidence of hemostatic efficacy following treatment with valoctocogene roxaparvovec, including significant reductions in bleeding events and Factor VIII infusions. We look forward to two year data results from our complete Phase 3 study with 134 participants in early 2022, and anticipate submitting a BLA in the second quarter of 2022, should data be supportive. More than ever, we believe that valoctocogene roxaparvovec gene therapy will be an important treatment option for people with severe hemophilia A. Given the superior bleed control seen at one year with valoctocogene roxaparvovec, and the burden of frequent, regular infusions with standard of care prophylaxis, we believe one infusion of valoctocogene roxaparvovec gene therapy has the potential to address the unmet need for bleed control, supported by our clinical results to date."
Financial Highlights:
Commercial Portfolio (Naglazyme, Vimizim, Brineura, Palynziq, Kuvan and Aldurazyme)
Late-stage Regulatory Portfolio (VOXZOGO and valoctocogene roxaparvovec)
Earlier-stage Development Portfolio (BMN 307, BMN 255, BMN 331, DiNA-001, Allen Institute Collaboration)
2021 Full-Year Financial Guidance (in millions, except %)
Item Provided April 29, 2021* Revised July 28, 2021*
Total Revenues $1,750 to $1,850 $1,790 to $1,880
Vimizim Net Product Revenues $570 to $610 $580 to $620
Kuvan Net Product Revenues $250 to $290 $260 to $290
Naglazyme Net Product Revenues $365 to $395 $375 to $405
Palynziq Net Product Revenues $210 to $250 $220 to $260
Brineura Net Product Revenues $120 to $140 Unchanged
Cost of Sales (% of Total Revenues) 23% to 25% Unchanged
Research and Development Expense $645 to $695 $645 to $685
Selling, General and Administrative Expense $725 to $775 $735 to $775
GAAP Net Loss ($130) to ($80) ($110) to ($60)
Non-GAAP Income (1) $170 to $220 $190 to $240
BioMarin will host a conference call and webcast to discuss second quarter and full-year 2021 financial results today, Wednesday, July 28, 2021 at 4:30 p.m. ET . This event can be accessed on the investor section of the BioMarin website at www.biomarin.com.
U.S./Canada Dial-in Number: 866.502.9859 Replay Dial-in Number: 855.859.2056
International Dial-in Number: 574.990.1362 Replay International Dial-in Number: 404.537.3406
Conference ID: 8363378 Conference ID: 8363378
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of several commercial therapies and multiple clinical and preclinical product candidates.
For additional information, please visit www.biomarin.com.
Forward-Looking Statements
BioMarin®, Brineura®, Kuvan®, Naglazyme®, Palynziq® and Vimizim® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. VOXZOGO™ is our trademark. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC. All other brand names and service marks, trademarks and other trade names appearing in this release are the property of their respective owners.
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2021 and December 31, 2020
(In thousands of U.S. dollars, except per share amounts)
June 30, 2021 December 31, 2020(1)
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 641,533 $ 649,158
Short-term investments 481,864 416,228
Accounts receivable, net 424,419 448,351
Inventory 710,975 698,548
Other current assets 99,046 129,934
Total current assets 2,357,837 2,342,219
Noncurrent assets:
Long-term investments 350,237 285,473
Property, plant and equipment, net 1,026,579 1,032,471
Intangible assets, net 394,298 417,271
Goodwill 196,199 196,199
Deferred tax assets 1,431,683 1,432,150
Other assets 141,663 142,237
Total assets $ 5,898,496 $ 5,848,020
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 411,132 $ 492,548
Short-term contingent consideration 32,212
Total current liabilities 443,344 492,548
Noncurrent liabilities:
Long-term convertible debt, net 1,077,110 1,075,145
Long-term contingent consideration 30,760 60,130
Other long-term liabilities 105,711 114,195
Total liabilities $ 1,656,925 $ 1,742,018
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 shares authorized; 183,321,820 and 181,740,999 shares issued and outstanding, respectively. 183 182
Additional paid-in capital 5,083,831 4,993,407
Company common stock held by Nonqualified Deferred Compensation Plan (10,207) (9,839)
Accumulated other comprehensive loss (939) (16,139)
Accumulated deficit (831,297) (861,609)
Total stockholders' equity 4,241,571 4,106,002
Total liabilities and stockholders' equity $ 5,898,496 $ 5,848,020
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three and Six Months Ended June 30, 2021 and 2020
(In thousands of U.S. dollars, except per share amounts)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 2021 2020
(unaudited) (unaudited) (unaudited) (unaudited)
REVENUES:
Net product revenues $ 486,670 $ 419,032 $ 954,439 $ 908,075
Royalty and other revenues 15,023 10,453 33,284 23,479
Total net revenues 501,693 429,485 987,723 931,554
OPERATING EXPENSES:
Cost of sales 127,062 97,967 247,228 209,341
Research and development 161,107 182,139 309,832 324,396
Selling, general and administrative 184,161 175,412 358,479 362,707
Intangible asset amortization and contingent consideration 17,691 14,912 35,426 30,589
Gain on sale of nonfinancial assets (59,495)
Total operating expenses 490,021 470,430 950,965 867,538
INCOME (LOSS) FROM OPERATIONS 11,672 (40,945) 36,758 64,016
Equity in the loss of BioMarin/Genzyme LLC (175) (79) (1,526) (156)
Interest income 4,471 4,291 6,910 9,535
Interest expense (3,817) (8,048) (7,621) (14,963)
Other income, net 2,005 2,508 2,863 647
INCOME (LOSS) BEFORE INCOME TAXES 14,156 (42,273) 37,384 59,079
Provision for (benefit from) income taxes 1,215 (13,090) 7,072 6,881
NET INCOME (LOSS) 12,941 (29,183) $ 30,312 $ 52,198
NET INCOME (LOSS) PER SHARE, BASIC $ 0.07 $ (0.16) $ 0.17 $ 0.29
NET INCOME (LOSS) PER SHARE, DILUTED $ 0.07 $ (0.16) $ 0.16 $ 0.28
Weighted average common shares outstanding, basic 182,844 180,729 182,311 180,314
Weighted average common shares outstanding, diluted 185,427 180,729 185,089 184,344
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Six Months Ended June 30, 2021 and 2020
(In thousands of U.S. dollars, except per share amounts)
Six Months Ended June 30,
2021 2020
(unaudited) (unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income $ 30,312 $ 52,198
Adjustments to reconcile net income to net cash used in operating activities:
Depreciation and amortization 55,214 51,180
Non-cash interest expense 2,082 9,534
Amortization of premium on investments 1,878 38
Stock-based compensation 104,346 91,956
Gain on sale of nonfinancial assets (59,495)
Deferred income taxes 1,204 (5,864)
Unrealized foreign exchange loss (gain) (1,004) 2,201
Non-cash changes in the fair value of contingent consideration 4,488 (584)
Other (376) (650)
Changes in operating assets and liabilities:
Accounts receivable, net 17,420 (8,028)
Inventory 6,379 (46,298)
Other current assets 34,331 20,441
Other assets 321 (5,599)
Accounts payable and accrued liabilities (60,884) (94,425)
Other long-term liabilities 585 5,938
Net cash provided by operating activities 196,296 12,543
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant and equipment (48,106) (66,716)
Maturities and sales of investments 348,941 170,111
Purchases of available-for-sale securities (484,572) (321,684)
Proceeds from sale of nonfinancial assets 67,159
Purchase of intangible assets (6,400) (10,786)
Investment in convertible note (8,709)
Other (908) (722)
Net cash used in investing activities (191,045) (171,347)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercises of awards under equity incentive plans 27,640 46,927
Taxes paid related to net share settlement of equity awards (38,731) (36,645)
Proceeds from convertible senior subordinated note offering, net 585,782
Repurchase of common stock (50,000)
Principal repayments of financing leases (1,941) (2,047)
Other (381)
Net cash provided by (used in) financing activities (13,413) 544,017
Effect of exchange rate changes on cash 537 (3,759)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS $ (7,625) $ 381,454
Cash and cash equivalents:
Beginning of period $ 649,158 $ 437,446
End of period $ 641,533 $ 818,900
The following table presents Net Product Revenues by Product:
Net Product Revenues by Product
(In millions of U.S. dollars)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 % Change 2021 2020 % Change
(unaudited) (unaudited) (unaudited) (unaudited)
Vimizim $ 171.7 $ 116.7 47 % $ 329.9 $ 253.9 30 %
PKU franchise 137.8 163.3 (16) % 262.6 319.9 (18) %
Naglazyme 118.8 81.0 47 % 226.1 195.3 16 %
Brineura 30.3 25.8 17 % 57.7 49.8 16 %
Firdapse (1) % 1.2 (100) %
Net Product Revenues Marketed by BioMarin $ 458.6 $ 386.8 $ 876.3 $ 820.1
Aldurazyme Net Product Revenues Marketed by Genzyme 28.1 32.3 (13) % 78.1 88.0 (11) %
Total Net Product Revenues $ 486.7 $ 419.1 $ 954.4 $ 908.1
The following table presents Net Product Revenues for the PKU Franchise by Product:
Net Product Revenues by Product for the PKU Franchise
(In millions of U.S. dollars)
Three Months Ended June 30, Six Months Ended June 30,
2021 2020 % Change 2021 2020 % Change
(unaudited) (unaudited) (unaudited) (unaudited)
Kuvan $ 78.8 $ 122.6 (36) % $ 149.6 $ 244.6 (39) %
Palynziq 59.0 40.7 45 % 113.0 75.3 50 %
Total PKU franchise $ 137.8 $ 163.3 (16) % $ 262.6 $ 319.9 (18) %
Non-GAAP Information
The results presented in this press release include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income is defined by the Company as GAAP Net Income/Loss excluding net interest expense, provision for income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and, in certain periods, certain other specified items, as detailed below when applicable. In addition, BioMarin includes in this press release the effects of these adjustments on certain components of GAAP Net Income/Loss for each of the periods presented. In this regard, Non-GAAP Income and its components, including Non-GAAP Cost of Sales, Non-GAAP Research and Development expenses, Non-GAAP Selling, General and Administrative expense, Non-GAAP Intangible Asset Amortization and Contingent Consideration, Non-GAAP Gain on the Sale of Intangible Asset and Non-GAAP Benefit From Income Taxes are statement of operations line items prepared on the same basis as, and therefore components of, the overall Non-GAAP measures.
Non-GAAP Income and its components are not meant to be considered in isolation, as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP measures; likewise, the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP measures. Because of the non-standardized definitions, the Non-GAAP measure as used by BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following table presents the reconciliation of GAAP Net Income (Loss) to Non-GAAP Income:
Reconciliation of GAAP Net Income (Loss) to Non-GAAP Income
(In millions of U.S. dollars)
(unaudited)
Three Months Ended June 30, Six Months Ended June 30, Guidance Year Ending
2021 2020 2021 2020 December 31, 2021
GAAP Net Income (Loss) $ 12.9 $ (29.2) $ 30.3 $ 52.2 $ (110.0) $ (60.0)
Interest expense (income), net (0.7) 3.7 0.7 5.4 11.0 11.0
Provision for (benefit from) income taxes 1.2 (13.1) 7.1 6.9 (16.0) (16.0)
Depreciation expense 11.8 9.7 24.3 20.0 48.0 48.0
Amortization expense 15.5 15.5 30.9 31.2 62.0 62.0
Stock-based compensation expense 54.9 45.1 104.3 92.0 186.0 186.0
Contingent consideration expense (benefit) 2.2 (0.6) 4.5 (0.6) 9.0 9.0
Gain on sale of nonfinancial assets (59.5)
Licensed In-Process R&D (1) 26.3 26.3
Non-GAAP Income $ 97.8 $ 57.4 $ 202.1 $ 173.9 $ 190.0 $ 240.0
The following reconciliation of the GAAP reported to the Non-GAAP information provides the details of the effects of the Non-GAAP adjustments on certain components of the Company's operating results for each of the periods presented.
Reconciliation of Certain GAAP Reported Information to Non-GAAP Information
(In millions of U.S. dollars)
(unaudited)
Three months ended June 30,
2021 2020
Adjustments Adjustments
GAAP Reported Interest, Taxes, Depreciation and Amortization Stock-Based Compensation, Contingent Consideration and Other Adjustments Non-GAAP GAAP Reported Interest, Taxes, Depreciation and Amortization Stock-Based Compensation, Contingent Consideration and Other Adjustments Non-GAAP
Cost of sales $ 127.1 $ $ (6.1) $ 121.0 $ 97.9 $ $ (4.9) $ 93.0
Research and development 161.1 (7.1) (20.8) 133.2 182.1 (4.6) (42.3) 135.2
Selling, general and administrative 184.2 (4.7) (28.0) 151.5 175.4 (5.1) (24.2) 146.1
Intangible asset amortization and contingent consideration 17.7 (15.5) (2.2) 14.9 (15.5) 0.6
Interest income (expense), net 0.7 (0.7) (3.7) 3.7
Provision for (benefit from) income taxes 1.2 (1.2) (13.1) 13.1
GAAP Net Income (Loss) / Non-GAAP Income $ 12.9 $ 27.8 $ 57.1 $ 97.8 $ (29.2) $ 15.8 $ 70.8 $ 57.4
Six months ended June 30,
2021 2020
Adjustments Adjustments
GAAP Reported Interest, Taxes, Depreciation and Amortization Stock-Based Compensation, Contingent Consideration and Other Adjustments Non-GAAP GAAP Reported Interest, Taxes, Depreciation and Amortization Stock-Based Compensation, Contingent Consideration and Other Adjustments Non-GAAP
Cost of sales $ 247.2 $ $ (12.6) $ 234.6 $ 209.3 $ $ (10.0) $ 199.3
Research and development 309.8 (14.6) (38.3) 256.9 324.4 (9.4) (56.0) 259.0
Selling, general and administrative 358.5 (9.7) (53.4) 295.4 362.7 (10.6) (52.3) 299.8
Intangible asset amortization and contingent consideration 35.4 (30.9) (4.5) 30.6 (31.2) 0.6
Gain on sale of nonfinancial assets 0.0 (59.5) 59.5
Interest expense, net (0.7) 0.7 (5.4) 5.4
Provision for income taxes 7.1 (7.1) 6.9 (6.9)
GAAP Net Income / Non-GAAP Income $ 30.3 $ 63.0 $ 108.8 $ 202.1 $ 52.2 $ 63.5 $ 58.2 $ 173.9
Contact:
Investors: Media:
Traci McCarty Debra Charlesworth
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 455-7558 (415) 455-7451
SOURCE BioMarin Pharmaceutical Inc.

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Last updated: Jul 28, 2021