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

Key Takeaway: SAN RAFAEL, Calif. , Oct. 27, 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 third quarter ended September

Full Press Release Details

SAN RAFAEL, Calif. , Oct. 27, 2021 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2021 2020 % Change 2021 2020 % Change
Total Revenues $ 408.7 $ 476.8 (14) % $ 1,396.5 $ 1,408.3 (1) %
Net Product Revenues Marketed by BioMarin (1) $ 369.5 $ 419.8 (12) % $ 1,245.8 $ 1,239.9 %
Vimizim Net Product Revenues $ 136.9 $ 147.9 (7) % $ 466.8 $ 401.8 16 %
Naglazyme Net Product Revenues $ 71.2 $ 76.3 (7) % $ 297.3 $ 271.6 9 %
Kuvan Net Product Revenues $ 67.7 $ 124.1 (45) % $ 217.3 $ 368.7 (41) %
Palynziq Net Product Revenues $ 60.7 $ 46.1 32 % $ 173.7 $ 121.4 43 %
Brineura Net Product Revenues $ 32.9 $ 25.4 30 % $ 90.6 $ 75.2 20 %
Voxzogo Net Product Revenues $ 0.1 $ n/a $ 0.1 $ n/a
Aldurazyme Net Product Revenues $ 24.4 $ 40.9 (40) % $ 102.5 $ 128.9 (20) %
GAAP Net Income (Loss) $ (36.5) $ 784.8 $ (6.2) $ 837.0
GAAP Net Income (Loss) per Share – Basic $ (0.20) $ 4.33 $ (0.03) $ 4.63
GAAP Net Income (Loss) per Share – Diluted $ (0.20) $ 4.01 $ (0.03) $ 4.39
Non-GAAP Income (2) $ 33.5 $ 98.7 $ 235.7 $ 272.6
September 30, 2021 December 31, 2020
Cash, cash equivalents and investments $ 1,546.1 $ 1,350.9
(1) Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Naglazyme, Kuvan, Palynziq, Brineura and Voxzogo (formerly known as vosoritide) for the three and nine months ended September 30, 2021 and includes Firdapse for the nine months ended September 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 nine months ended September 30, 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 third quarter ended September 30, 2021.
"As we begin the last quarter of 2021, we are very pleased to be improving both top and bottom-line financial guidance for the full-year," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "Uneven ordering patterns are a consistent element of our dynamic global commercial business, making full-year results the key indicator of product demand. The essential nature of our medicines to the people who rely on them, gives us confidence in the growth prospects ahead. We plan to finish 2021 strong and expect meaningful growth in revenues in 2022 leading to anticipated GAAP profitability next year. We look forward to providing full guidance for 2022 early next year, especially given early demand signals for Voxzogo, for the treatment of achondroplasia, in Europe , and the potential for Voxzogo to be approved in the U.S. next month."
Mr. Bienaimé continued, "Foundational milestones are tracking to plan, starting with the European approval and launch of Voxzogo in the quarter. The level of interest in Voxzogo following approval has exceeded our expectations. If Voxzogo is approved in the U.S. next month, we expect the global Voxzogo launch to contribute meaningfully to our commercial business. Our next significant read-out, the two-year data from the 134-participant Phase 3 study with valoctocogene roxaparvovec gene therapy for the treatment of severe hemophilia A, will be shared in early 2022. We anticipate resubmitting the U.S. application in the second quarter of 2022, and we continue to anticipate the European opinion in the second quarter of 2022, should data be supportive. The cascade of these potential new product approvals, including global approvals of valoctocogene roxaparvovec and U.S. approval of Voxzogo, sets us up for significant potential growth beginning in 2022."
Financial Highlights:
Late-stage Regulatory Portfolio (Voxzogo and valoctocogene roxaparvovec)
Earlier-stage Development Portfolio (BMN 307, BMN 255, BMN 331, BMN 351, DiNA-001, Allen Institute Collaboration, Deep Genomics)
2021 Full-Year Financial Guidance (in millions, except %)
Item Provided July 28, 2021* Revised October 27, 2021*
Total Revenues $1,790 to $1,880 $1,820 to $1,880
Vimizim Net Product Revenues $580 to $620 $595 to $620
Naglazyme Net Product Revenues $375 to $405 Unchanged
Palynziq Net Product Revenues $220 to $260 $230 to $260
Kuvan Net Product Revenues $260 to $290 $265 to $290
Brineura Net Product Revenues $120 to $140 Unchanged
Cost of Sales (% of Total Revenues) 23% to 25% Unchanged
Research and Development Expense $645 to $685 $635 to $675
Selling, General and Administrative Expense $735 to $775 Unchanged
GAAP Net Loss ($110) to ($60) ($85) to ($45)
Non-GAAP Income (1) $190 to $240 $215 to $255
*2021 Guidance takes into consideration ongoing expected impact from the COVID-19 pandemic assuming consistent trends experienced during 2020 and the nine months ended September 30, 2021.
(1) All Financial Guidance items are calculated based on U.S. GAAP with the exception of Non-GAAP Income. 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 corresponding GAAP reported information.
BioMarin will host a conference call and webcast to discuss third quarter and year to date 2021 financial results today, Wednesday, October 27, 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: 2382767 Conference ID: 2382767
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 a trademark of BioMarin Pharmaceutical Inc. 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.
Contact:
Investors: Media:
Traci McCarty Debra Charlesworth
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 455-7558 (415) 455-7451
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, 2021 and December 31, 2020
(In thousands of U.S. dollars, except per share amounts)
September 30, 2021 December 31, 2020(1)
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 617,143 $ 649,158
Short-term investments 462,333 416,228
Accounts receivable, net 374,937 448,351
Inventory 749,406 698,548
Other current assets 107,751 129,934
Total current assets 2,311,570 2,342,219
Noncurrent assets:
Long-term investments 466,618 285,473
Property, plant and equipment, net 1,024,787 1,032,471
Intangible assets, net 388,487 417,271
Goodwill 196,199 196,199
Deferred tax assets 1,445,109 1,432,150
Other assets 144,705 142,237
Total assets $ 5,977,475 $ 5,848,020
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 466,711 $ 492,548
Short-term contingent consideration 48,187
Total current liabilities 514,898 492,548
Noncurrent liabilities:
Long-term convertible debt, net 1,078,093 1,075,145
Long-term contingent consideration 15,204 60,130
Other long-term liabilities 103,131 114,195
Total liabilities $ 1,711,326 $ 1,742,018
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 shares authorized; 183,567,424 and 181,740,999 shares issued and outstanding, respectively. 184 182
Additional paid-in capital 5,133,742 4,993,407
Company common stock held by Nonqualified Deferred Compensation Plan (10,225) (9,839)
Accumulated other comprehensive income (loss) 10,239 (16,139)
Accumulated deficit (867,791) (861,609)
Total stockholders' equity 4,266,149 4,106,002
Total liabilities and stockholders' equity $ 5,977,475 $ 5,848,020
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three and Nine Months Ended September 30, 2021 and 2020
(In thousands of U.S. dollars, except per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
2021 2020 2021 2020
(unaudited) (unaudited) (unaudited) (unaudited)
REVENUES:
Net product revenues $ 393,840 $ 460,741 $ 1,348,279 $ 1,368,816
Royalty and other revenues 14,902 16,043 48,186 39,522
Total revenues 408,742 476,784 1,396,465 1,408,338
OPERATING EXPENSES:
Cost of sales 103,537 188,793 350,765 398,134
Research and development 157,869 147,053 467,701 471,449
Selling, general and administrative 183,333 179,450 541,812 542,157
Intangible asset amortization and contingent consideration 17,222 17,429 52,648 48,018
Gain on sale of nonfinancial assets (59,495)
Total operating expenses 461,961 532,725 1,412,926 1,400,263
INCOME (LOSS) FROM OPERATIONS (53,219) (55,941) (16,461) 8,075
Equity in the income (loss) of BioMarin/Genzyme LLC 177 (921) (1,349) (1,077)
Interest income 1,827 4,004 8,737 13,539
Interest expense (3,870) (9,597) (11,491) (24,560)
Other income, net 8,925 1,239 11,788 1,886
INCOME (LOSS) BEFORE INCOME TAXES (46,160) (61,216) (8,776) (2,137)
Benefit from income taxes (9,666) (846,019) (2,594) (839,138)
NET INCOME (LOSS) (36,494) 784,803 $ (6,182) $ 837,001
NET INCOME (LOSS) PER SHARE, BASIC $ (0.20) $ 4.33 $ (0.03) $ 4.63
NET INCOME (LOSS) PER SHARE, DILUTED $ (0.20) $ 4.01 $ (0.03) $ 4.39
Weighted average common shares outstanding, basic 183,214 181,142 182,616 180,592
Weighted average common shares outstanding, diluted 183,214 197,674 182,616 194,959
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Nine Months Ended September 30, 2021 and 2020
(In thousands of U.S. dollars)
Nine Months Ended September 30,
2021 2020
(unaudited) (unaudited)
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) $ (6,182) $ 837,001
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization 82,053 77,814
Non-cash interest expense 3,114 14,766
Amortization of premium on investments 3,279 175
Stock-based compensation 153,372 142,125
Gain on sale of nonfinancial assets (59,495)
Inventory reserves, net of stock-based compensation 75,609
Deferred income taxes (12,020) (854,199)
Unrealized foreign exchange (gain) loss (1,347) 9,082
Non-cash changes in the fair value of contingent consideration 6,254 1,352
Other (1,317) 388
Changes in operating assets and liabilities:
Accounts receivable, net 65,513 (32,915)
Inventory (19,125) (73,310)
Other current assets 27,029 32,848
Other assets (407) (5,543)
Accounts payable and accrued liabilities (7,129) (76,174)
Other long-term liabilities 269 9,225
Net cash provided by operating activities 293,356 98,749
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property, plant and equipment (66,840) (83,286)
Maturities and sales of investments 502,112 345,224
Purchases of available-for-sale securities (737,144) (369,942)
Proceeds from sale of nonfinancial assets 67,159
Purchase of intangible assets (8,026) (14,369)
Investment in convertible note (8,709)
Other (994) (725)
Net cash used in investing activities (310,892) (64,648)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercises of awards under equity incentive plans 32,877 60,268
Taxes paid related to net share settlement of equity awards (44,428) (42,667)
Repurchase of common stock (50,000)
Proceeds from convertible senior subordinated note offering, net 585,752
Principal repayments of financing leases (2,492) (6,080)
Other (401)
Net cash provided by (used in) financing activities (14,444) 547,273
Effect of exchange rate changes on cash (35) (3,145)
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS $ (32,015) $ 578,229
Cash and cash equivalents:
Beginning of period $ 649,158 $ 437,446
End of period $ 617,143 $ 1,015,675
The following table presents Net Product Revenues by Product:
Net Product Revenues by Product
(In millions of U.S. dollars)
Three Months Ended September 30, Nine Months Ended September 30,
2021 2020 % Change 2021 2020 % Change
(unaudited) (unaudited) (unaudited) (unaudited)
Vimizim $ 136.9 $ 147.9 (7) % $ 466.8 $ 401.8 16 %
Naglazyme 71.2 76.3 (7) % 297.3 271.6 9 %
Kuvan 67.7 124.1 (45) % 217.3 368.7 (41) %
Palynziq 60.7 46.1 32 % 173.7 121.4 43 %
Brineura 32.9 25.4 30 % 90.6 75.2 20 %
Voxzogo 0.1 n/a 0.1 n/a
Firdapse (1) % 1.2 (100) %
Net Product Revenues Marketed by BioMarin $ 369.5 $ 419.8 $ 1,245.8 $ 1,239.9
Aldurazyme Net Product Revenues Marketed by Genzyme 24.4 40.9 (40) % 102.5 128.9 (20) %
Total Net Product Revenues $ 393.9 $ 460.7 $ 1,348.3 $ 1,368.8
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 September 30, Nine Months Ended September 30, Guidance Year Ending
2021 2020 2021 2020 December 31, 2021
GAAP Net Income (Loss) $ (36.5) $ 784.8 $ (6.2) $ 837.0 $ (85.0) $ (45.0)
Interest expense, net 2.0 5.6 2.8 11.0 11.0 11.0
Benefit from income taxes (9.7) (846.0) (2.6) (839.1) (16.0) (16.0)
Depreciation expense 11.4 11.1 35.7 31.1 48.0 48.0
Amortization expense 15.4 15.5 46.3 46.7 62.0 62.0
Stock-based compensation expense 49.1 50.2 153.4 142.2 186.0 186.0
Contingent consideration expense 1.8 1.9 6.3 1.3 9.0 9.0
Provision for inventory reserve, net (1) 75.6 75.6
Gain on sale of nonfinancial assets (59.5)
Licensed In-Process R&D (2) 26.3
Non-GAAP Income $ 33.5 $ 98.7 $ 235.7 $ 272.6 $ 215.0 $ 255.0
(1) Represents a $81.2 million charge related to pre-launch valoctocogene roxaparvovec inventory, net of stock-based compensation, as a result of the unexpected delays in anticipated regulatory approvals.
(2) Represents the upfront license fee paid to a third party and recognized as R&D expense in the second quarter of 2020.
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 September 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 $ 103.5 $ $ (4.3) $ 99.2 $ 188.8 $ $ (86.0) $ 102.8
Research and development 157.9 (6.3) (17.9) 133.7 147.1 (5.8) (15.7) 125.6
Selling, general and administrative 183.3 (5.1) (26.9) 151.3 179.5 (5.3) (24.1) 150.1
Intangible asset amortization and contingent consideration 17.2 (15.4) (1.8) 17.4 (15.5) (1.9)
Interest expense, net (2.0) 2.0 (5.6) 5.6
Benefit from income taxes (9.7) 9.7 (846.0) 846.0
GAAP Net Income (Loss) / Non-GAAP Income $ (36.5) $ 19.1 $ 50.9 $ 33.5 $ 784.8 $ (813.8) $ 127.7 $ 98.7
Nine months ended September 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 $ 350.8 $ $ (16.9) $ 333.9 $ 398.1 $ $ (96.0) $ 302.1
Research and development 467.7 (20.9) (56.2) 390.6 471.4 (15.2) (71.7) 384.5
Selling, general and administrative 541.8 (14.8) (80.3) 446.7 542.2 (15.9) (76.4) 449.9
Intangible asset amortization and contingent consideration 52.6 (46.3) (6.3) 48.0 (46.7) (1.3)
Gain on sale of nonfinancial assets (59.5) 59.5
Interest expense, net (2.8) 2.8 (11.0) 11.0
Benefit from income taxes (2.6) 2.6 (839.1) 839.1
GAAP Net Income (Loss) / Non-GAAP Income $ (6.2) $ 82.2 $ 159.7 $ 235.7 $ 837.0 $ (750.3) $ 185.9 $ 272.6
SOURCE BioMarin Pharmaceutical Inc.

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Last updated: Oct 27, 2021