Full Press Release Details
| Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) | |||||
| Three Months Ended March 31, | |||||
| 2022 | 2021 | % Change | |||
| Total Revenues | $ 519.4 | $ 486.0 | 7 % | ||
| Net Product Revenues Marketed by BioMarin (1) | $ 481.1 | $ 417.8 | 15 % | ||
| Vimizim Net Product Revenues | $ 183.0 | $ 158.4 | 16 % | ||
| Naglazyme Net Product Revenues | $ 128.0 | $ 107.3 | 19 % | ||
| Kuvan Net Product Revenues | $ 59.3 | $ 70.8 | (16) % | ||
| Palynziq Net Product Revenues | $ 54.9 | $ 54.0 | 2 % | ||
| Brineura Net Product Revenues | $ 36.2 | $ 27.3 | 33 % | ||
| Voxzogo Net Product Revenues | $ 19.7 | $ — | n/a | ||
| Aldurazyme Net Product Revenues | $ 24.4 | $ 50.0 | (51) % | ||
| GAAP Net Income | $ 120.8 | $ 17.4 | |||
| GAAP Net Income per Share – Basic | $ 0.66 | $ 0.10 | |||
| GAAP Net Income per Share – Diluted | $ 0.63 | $ 0.09 | |||
| Non-GAAP Income (2) | $ 105.3 | $ 104.4 | |||
| March 31, 2022 | December 31, 2021 | ||||
| Cash, cash equivalents and investments | $ 1,519.1 | $ 1,521.7 | |||
| (1) Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Naglazyme, Kuvan, Palynziq, Brineura and Voxzogo for the three months ended March 31, 2022 and 2021, each calculated in accordance with Generally Accepted Accounting Principles in the United States (U.S. GAAP). Sanofi is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. | |||||
| (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 9 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. |
SAN RAFAEL, Calif. , April 27, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the first quarter ended March 31, 2022.
"We begin 2022 from a position of financial strength including significant contributions from our newest product, Voxzogo, the only approved therapy for children with achondroplasia. We continue to be encouraged by the high level of interest in Voxzogo from families and physicians worldwide seeking treatment that addresses the underlying cause of achondroplasia," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "As we stated last quarter, in 2022 we expect to return to double-digit revenue growth and profitability. We begin the journey with record first quarter revenues, and foresee continued momentum based on the essential nature of our innovative medicines for our patients around the world."
BioMarin Announces Record Revenues in First Quarter 2022
Mr. Bienaimé continued, "The regulatory team has been working collaboratively with the European Medicines Agency as we near the completion of the application review procedure for potential approval of valoctocogene roxaparvovec gene therapy for the treatment of severe hemophilia A. We remain encouraged by the potential benefit of valoctocogene roxaparvovec for people with severe hemophilia A based on the clinically meaningful study results to date. These demonstrate an 85% reduction in annualized bleeding rates compared to baseline using standard of care. With potential approvals of valoctocogene roxaparvovec in Europe and United States , the continued strong launch of Voxzogo and our anticipated transition to sustainable profitability, we believe 2022 will be a transformational year for all BioMarin stakeholders."
Financial Highlights:
These factors were offset by the following:
Late-stage Regulatory Portfolio (Voxzogo and valoctocogene roxaparvovec)
Earlier-stage Development Portfolio (BMN 255, BMN 331, BMN 351, BMN 349, BMN 293 (DiNA-001))
| 2022 Full-Year Financial Guidance (in millions, except %) | ||||||||
| Item | Provided February 23, 2022 | Revised April 27, 2022 | ||||||
| Total Revenues | $2,050 | to | $2,150 | Unchanged | ||||
| Vimizim Net Product Revenues | $650 | to | $700 | Unchanged | ||||
| Naglazyme Net Product Revenues | $400 | to | $440 | Unchanged | ||||
| Palynziq Net Product Revenues | $280 | to | $310 | Unchanged | ||||
| Kuvan Net Product Revenues | $225 | to | $250 | Unchanged | ||||
| Brineura Net Product Revenues | $145 | to | $160 | Unchanged | ||||
| Voxzogo Net Product Revenues | $90 | to | $115 | $100 | to | $125 | ||
| Cost of Sales (% of Total Revenues) | 23 % | to | 25% | Unchanged | ||||
| Research and Development Expense | $665 | to | $715 | Unchanged | ||||
| Selling, General and Administrative Expense | $790 | to | $840 | Unchanged | ||||
| GAAP Net Income | $95 | to | $135 | Unchanged | ||||
| Non-GAAP Income (1) | $350 | to | $390 | Unchanged | ||||
| (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 9 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 first quarter and year to date 2022 financial results today, Wednesday, April 27, 2022 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: 9770836 | Conference ID: 9770836 |
About BioMarin 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 seven commercial products and multiple clinical and preclinical product candidates for the treatment of various diseases. For additional information, please visit www.biomarin.com.
BioMarin®, Brineura®, Kuvan®, Naglazyme®, Palynziq®, Vimizim® and Voxzogo® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. 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 March 31, 2022 and December 31, 2021 (In thousands of U.S. dollars, except per share amounts) | |||
| March 31, 2022 | December 31, 2021 (1) | ||
| ASSETS | (unaudited) | ||
| Current assets: | |||
| Cash and cash equivalents | $ 605,440 | $ 587,276 | |
| Short-term investments | 450,798 | 426,599 | |
| Accounts receivable, net | 430,147 | 373,399 | |
| Inventory | 786,356 | 776,669 | |
| Other current assets | 121,283 | 110,442 | |
| Total current assets | 2,394,024 | 2,274,385 | |
| Noncurrent assets: | |||
| Long-term investments | 462,827 | 507,793 | |
| Property, plant and equipment, net | 1,039,544 | 1,035,461 | |
| Intangible assets, net | 374,251 | 388,652 | |
| Goodwill | 196,199 | 196,199 | |
| Deferred tax assets | 1,446,676 | 1,449,075 | |
| Other assets | 149,186 | 151,760 | |
| Total assets | $ 6,062,707 | $ 6,003,325 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||
| Current liabilities: | |||
| Accounts payable and accrued liabilities | $ 426,418 | $ 491,590 | |
| Short-term contingent consideration | 64,000 | 48,232 | |
| Total current liabilities | 490,418 | 539,822 | |
| Noncurrent liabilities: | |||
| Long-term convertible debt, net | 1,080,061 | 1,079,077 | |
| Long-term contingent consideration | — | 15,167 | |
| Other long-term liabilities | 100,913 | 98,519 | |
| Total liabilities | 1,671,392 | 1,732,585 | |
| Stockholders' equity: | |||
| Common stock, $0.001 par value: 500,000,000 shares authorized; 184,901,764 and 183,912,514 shares issued and outstanding, respectively | 185 | 184 | |
| Additional paid-in capital | 5,206,287 | 5,191,502 | |
| Company common stock held by Nonqualified Deferred Compensation Plan | (9,389) | (9,689) | |
| Accumulated other comprehensive income (loss) | (877) | 14,432 | |
| Accumulated deficit | (804,891) | (925,689) | |
| Total stockholders' equity | 4,391,315 | 4,270,740 | |
| Total liabilities and stockholders' equity | $ 6,062,707 | $ 6,003,325 | |
| (1) December 31, 2021 balances were derived from the audited Consolidated Financial Statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2022. |
| BIOMARIN PHARMACEUTICAL INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS Three Months Ended March 31, 2022 and 2021 (In thousands of U.S. dollars, except per share amounts) | |||
| Three Months Ended March 31, | |||
| 2022 | 2021 | ||
| (unaudited) | (unaudited) | ||
| REVENUES: | |||
| Net product revenues | $ 505,525 | $ 467,769 | |
| Royalty and other revenues | 13,834 | 18,261 | |
| Total revenues | 519,359 | 486,030 | |
| OPERATING EXPENSES: | |||
| Cost of sales | 116,965 | 120,166 | |
| Research and development | 160,836 | 148,725 | |
| Selling, general and administrative | 194,619 | 174,318 | |
| Intangible asset amortization and contingent consideration | 17,612 | 17,735 | |
| Gain on sale of nonfinancial assets, net | (108,000) | — | |
| Total operating expenses | 382,032 | 460,944 | |
| INCOME FROM OPERATIONS | 137,327 | 25,086 | |
| Interest income | 1,820 | 2,439 | |
| Interest expense | (3,806) | (3,804) | |
| Other expense, net | (1,154) | (493) | |
| INCOME BEFORE INCOME TAXES | 134,187 | 23,228 | |
| Provision for income taxes | 13,389 | 5,857 | |
| NET INCOME | $ 120,798 | $ 17,371 | |
| NET INCOME PER SHARE, BASIC | $ 0.66 | $ 0.10 | |
| NET INCOME PER SHARE, DILUTED | $ 0.63 | $ 0.09 | |
| Weighted average common shares outstanding, basic | 183,990 | 181,772 | |
| Weighted average common shares outstanding, diluted | 194,886 | 184,365 |
| BIOMARIN PHARMACEUTICAL INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS Three Months Ended March 31, 2022 and 2021 (In thousands of U.S. dollars) | |||
| Three Months Ended March 31, | |||
| 2022 | 2021 | ||
| (unaudited) | (unaudited) | ||
| CASH FLOWS FROM OPERATING ACTIVITIES: | |||
| Net income | $ 120,798 | $ 17,371 | |
| Adjustments to reconcile net income to net cash (used in) provided by operating activities: | |||
| Depreciation and amortization | 27,343 | 27,983 | |
| Non-cash interest expense | 1,033 | 1,043 | |
| Amortization of premium on investments | 1,652 | 673 | |
| Stock-based compensation | 47,833 | 49,503 | |
| Gain on sale of nonfinancial assets, net | (108,000) | — | |
| Deferred income taxes | 4,800 | 3,335 | |
| Unrealized foreign exchange (gain) loss | (6,887) | 3,950 | |
| Non-cash changes in the fair value of contingent consideration | 1,989 | 2,255 | |
| Other | 700 | (871) | |
| Changes in operating assets and liabilities: | |||
| Accounts receivable, net | (54,813) | 40,294 | |
| Inventory | 1,125 | (6,425) | |
| Other current assets | (8,011) | 42,784 | |
| Other assets | 1,440 | 1,617 | |
| Accounts payable and accrued liabilities | (78,143) | (72,304) | |
| Other long-term liabilities | 1,710 | 2,304 | |
| Net cash (used in) provided by operating activities | (45,431) | 113,512 | |
| CASH FLOWS FROM INVESTING ACTIVITIES: | |||
| Purchases of property, plant and equipment | (28,817) | (25,507) | |
| Maturities and sales of investments | 155,818 | 194,637 | |
| Purchases of available-for-sale securities | (147,361) | (237,171) | |
| Proceeds from sale of nonfinancial assets | 110,000 | — | |
| Purchase of intangible assets | (1,858) | (2,747) | |
| Net cash provided by (used in) investing activities | 87,782 | (70,788) | |
| CASH FLOWS FROM FINANCING ACTIVITIES: | |||
| Proceeds from exercises of awards under equity incentive plans | 8,235 | 5,817 | |
| Taxes paid related to net share settlement of equity awards | (32,949) | (29,097) | |
| Principal repayments of financing leases | (566) | (1,084) | |
| Net cash used in financing activities | (25,280) | (24,364) | |
| Effect of exchange rate changes on cash | 1,093 | (205) | |
| NET INCREASE IN CASH AND CASH EQUIVALENTS | $ 18,164 | $ 18,155 | |
| Cash and cash equivalents: | |||
| Beginning of period | $ 587,276 | $ 649,158 | |
| End of period | $ 605,440 | $ 667,313 |
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 to Non-GAAP Income:
| Reconciliation of GAAP Net Income to Non-GAAP Income (In millions of U.S. dollars) (unaudited) | |||||||
| Three Months Ended March 31, | Guidance (1) Year Ending | ||||||
| 2022 | 2021 | December 31, 2022 | |||||
| GAAP Net Income | $ 120.8 | $ 17.4 | $ 95.0 | — | $ 135.0 | ||
| Interest expense, net | 2.0 | 1.4 | 9.0 | ||||
| Provision for income taxes | 13.4 | 5.9 | 47.0 | ||||
| Depreciation expense | 11.7 | 12.5 | 44.0 | ||||
| Amortization expense | 15.6 | 15.4 | 63.0 | ||||
| Stock-based compensation expense | 47.8 | 49.5 | 195.0 | ||||
| Contingent consideration expense | 2.0 | 2.3 | 5.0 | ||||
| Gain on sale of nonfinancial assets, net | (108.0) | — | (108.0) | ||||
| Non-GAAP Income | $ 105.3 | $ 104.4 | $ 350.0 | — | $ 390.0 | ||
| (1) The adjustments/reconciling items included in the Guidance Year Ending December 31, 2022 column are presented to facilitate the reconciliation of Non-GAAP Income to its closest GAAP financial metric, GAAP Net Income. The Company notes that the specific amounts included in each reconciling line item above represent approximations of the underlying adjustments from GAAP Net Income to Non-GAAP Income, and that actual 2022 results for each reconciling line item may be different, in some cases materially, than the amounts listed above as a result of uncertainty regarding, and the potential variability of, those items. |
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 March 31, | |||||||||||||||
| 2022 | 2021 | ||||||||||||||
| 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 | $ 117.0 | $ — | $ (4.3) | $ 112.7 | $ 120.2 | $ — | $ (6.5) | $ 113.7 | |||||||
| Research and development | 160.8 | (7.4) | (17.2) | 136.2 | 148.7 | (7.5) | (17.5) | 123.7 | |||||||
| Selling, general and administrative | 194.6 | (4.3) | (26.3) | 164.0 | 174.3 | (5.0) | (25.5) | 143.8 | |||||||
| Intangible asset amortization and contingent consideration | 17.6 | (15.6) | (2.0) | — | 17.7 | (15.4) | (2.3) | — | |||||||
| Gain on sale of nonfinancial assets, net | (108.0) | — | 108.0 | — | — | — | — | — | |||||||
| Interest expense, net | (2.0) | 2.0 | — | — | (1.4) | 1.4 | — | — | |||||||
| Provision for income taxes | 13.4 | (13.4) | — | — | 5.9 | (5.9) | — | — | |||||||
| GAAP Net Income / Non-GAAP Income | $ 120.8 | $ 42.7 | $ (58.2) | $ 105.3 | $ 17.4 | $ 35.2 | $ 51.8 | $ 104.4 |
| Contact: | ||
| Investors: | Media: | |
| Traci McCarty | Debra Charlesworth | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 455-7558 | (415) 455-7451 |
SOURCE BioMarin Pharmaceutical Inc.