Full Press Release Details
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | ||||||
| Total Revenues | $ 533.8 | $ 501.7 | 6 % | $ 1,053.2 | $ 987.7 | 7 % | |||||
| Net Product Revenues Marketed by BioMarin (1) | $ 480.4 | $ 458.6 | 5 % | $ 961.5 | $ 876.3 | 10 % | |||||
| Vimizim Net Product Revenues | $ 173.3 | $ 171.7 | 1 % | $ 356.4 | $ 329.9 | 8 % | |||||
| Naglazyme Net Product Revenues | $ 115.8 | $ 118.8 | (3) % | $ 243.8 | $ 226.1 | 8 % | |||||
| Palynziq Net Product Revenues | $ 61.6 | $ 59.0 | 4 % | $ 116.5 | $ 113.0 | 3 % | |||||
| Kuvan Net Product Revenues | $ 57.6 | $ 78.8 | (27) % | $ 116.9 | $ 149.6 | (22) % | |||||
| Brineura Net Product Revenues | $ 37.7 | $ 30.3 | 24 % | $ 73.9 | $ 57.7 | 28 % | |||||
| Voxzogo Net Product Revenues | $ 34.4 | $ — | n/a | $ 54.0 | $ — | n/a | |||||
| Aldurazyme Net Product Revenues | $ 37.3 | $ 28.1 | 33 % | $ 61.7 | $ 78.1 | (21) % | |||||
| GAAP Net Income | $ 27.7 | $ 12.9 | $ 148.5 | $ 30.3 | |||||||
| GAAP Net Income per Share – Basic | $ 0.15 | $ 0.07 | $ 0.80 | $ 0.17 | |||||||
| GAAP Net Income per Share – Diluted | $ 0.15 | $ 0.07 | $ 0.79 | $ 0.16 | |||||||
| Non-GAAP Income (2) | $ 109.4 | $ 97.8 | $ 214.6 | $ 202.1 |
| June 30, 2022 | December 31, 2021 | ||
| Total cash, cash equivalents & investments | $ 1,522.3 | $ 1,521.7 |
| (1) | Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Naglazyme, Palynziq, Kuvan, Brineura and Voxzogo for the three and six months ended June 30, 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. , Aug. 3, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the second quarter ended June 30, 2022.
BioMarin Announces Record Revenues in Second Quarter 2022; Increases Full-year 2022 Top and Bottom-line Guidance
Mr. Bienaimé added, "In addition to continued robust demand for Voxzogo throughout the United States and Europe , underscored by today's significant increase in full-year 2022 guidance for Voxzogo net product revenues to between $130 million and $160 million , we were thrilled to receive commercial approval in both Japan and Australia in the quarter. As we said previously, in 2022 we expect to return to double-digit revenue growth and profitability, and we are tracking to plan as demonstrated by record revenues in both the first and second quarters of this year."
Financial Highlights:
New Product Launches and Anticipated Approvals (Voxzogo and Roctavian)
Mid-stage Product Life Cycle Expansion Opportunities (Voxzogo and Roctavian)
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 April 27, 2022 | Revised August 3, 2022 | ||||||||||
| Total Revenues | $2,050 | to | $2,150 | $2,060 | to | $2,160 | ||||||
| Vimizim Net Product Revenues | $650 | to | $700 | $655 | to | $700 | ||||||
| Naglazyme Net Product Revenues | $400 | to | $440 | $415 | to | $450 | ||||||
| Palynziq Net Product Revenues | $280 | to | $310 | $250 | to | $275 | ||||||
| Kuvan Net Product Revenues | $225 | to | $250 | $210 | to | $235 | ||||||
| Brineura Net Product Revenues | $145 | to | $160 | Unchanged | ||||||||
| Voxzogo Net Product Revenues | $100 | to | $125 | $130 | to | $160 | ||||||
| Cost of Sales (% of Total Revenues) | 23.0 % | to | 25.0 % | 22.5 % | to | 24.5 % | ||||||
| Research and Development Expense | $665 | to | $715 | Unchanged | ||||||||
| Selling, General and Administrative Expense | $790 | to | $840 | Unchanged | ||||||||
| GAAP Net Income | $95 | to | $135 | $105 | to | $145 | ||||||
| Non-GAAP Income (1) | $350 | to | $390 | Unchanged |
BioMarin will host a conference call and webcast to discuss second quarter and year to date 2022 financial results today, Wednesday, August 3, 2022 at 4:30 p.m. ET . This event can be accessed through this link or on the investor section of the BioMarin website at www.biomarin.com.
| U.S./Canada Dial-in Number: 800-231-0316 | Replay Dial-in Number: 800-645-7964 |
| International Dial-in Number: 314-696-0504 | Replay International Dial-in Number: 757-849-6722 |
| Conference ID: 8072033 | Conference ID: 2361# |
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.
Forward-Looking Statements
BioMarin®, Brineura®, Kuvan®, Naglazyme®, Palynziq®, Vimizim® and Voxzogo® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Roctavian TM 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.
| BIOMARIN PHARMACEUTICAL INC. | |||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||
| June 30, 2022 and December 31, 2021 | |||
| (In thousands of U.S. dollars, except per share amounts) | |||
| June 30, 2022 | December 31, 2021 ⁽¹⁾ | ||
| ASSETS | (unaudited) | ||
| Current assets: | |||
| Cash and cash equivalents | $ 619,802 | $ 587,276 | |
| Short-term investments | 489,945 | 426,599 | |
| Accounts receivable, net | 466,507 | 373,399 | |
| Inventory | 802,315 | 776,669 | |
| Other current assets | 139,029 | 110,442 | |
| Total current assets | 2,517,598 | 2,274,385 | |
| Noncurrent assets: | |||
| Long-term investments | 412,503 | 507,793 | |
| Property, plant and equipment, net | 1,049,464 | 1,035,461 | |
| Intangible assets, net | 369,368 | 388,652 | |
| Goodwill | 196,199 | 196,199 | |
| Deferred tax assets | 1,448,912 | 1,449,075 | |
| Other assets | 151,797 | 151,760 | |
| Total assets | $ 6,145,841 | $ 6,003,325 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||
| Current liabilities: | |||
| Accounts payable and accrued liabilities | $ 434,773 | $ 491,590 | |
| Short-term contingent consideration | 29,954 | 48,232 | |
| Total current liabilities | 464,727 | 539,822 | |
| Noncurrent liabilities: | |||
| Long-term convertible debt, net | 1,081,047 | 1,079,077 | |
| Long-term contingent consideration | — | 15,167 | |
| Other long-term liabilities | 95,260 | 98,519 | |
| Total liabilities | 1,641,034 | 1,732,585 | |
| Stockholders' equity: | |||
| Common stock, $0.001 par value: 500,000,000 shares authorized; 185,452,454 and 183,912,514 shares issued and outstanding, respectively | 186 | 184 | |
| Additional paid-in capital | 5,272,666 | 5,191,502 | |
| Company common stock held by the Nonqualified Deferred Compensation Plan | (9,290) | (9,689) | |
| Accumulated other comprehensive income | 18,472 | 14,432 | |
| Accumulated deficit | (777,227) | (925,689) | |
| Total stockholders' equity | 4,504,807 | 4,270,740 | |
| Total liabilities and stockholders' equity | $ 6,145,841 | $ 6,003,325 |
| BIOMARIN PHARMACEUTICAL INC. | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| Six Months Ended June 30, 2022 and 2021 | |||||||
| (In thousands of U.S. dollars, except per share amounts) | |||||||
| (unaudited) | |||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||
| 2022 | 2021 | 2022 | 2021 | ||||
| REVENUES: | |||||||
| Net product revenues | $ 517,660 | $ 486,670 | $ 1,023,185 | $ 954,439 | |||
| Royalty and other revenues | 16,138 | 15,023 | 29,972 | 33,284 | |||
| Total revenues | 533,798 | 501,693 | 1,053,157 | 987,723 | |||
| OPERATING EXPENSES: | |||||||
| Cost of sales | 123,126 | 127,062 | 240,091 | 247,228 | |||
| Research and development | 158,190 | 161,107 | 319,026 | 309,832 | |||
| Selling, general and administrative | 196,835 | 184,161 | 391,454 | 358,479 | |||
| Intangible asset amortization and contingent consideration | 16,495 | 17,691 | 34,107 | 35,426 | |||
| Gain on sale of nonfinancial assets, net | — | — | (108,000) | — | |||
| Total operating expenses | 494,646 | 490,021 | 876,678 | 950,965 | |||
| INCOME FROM OPERATIONS | 39,152 | 11,672 | 176,479 | 36,758 | |||
| Interest income | 2,505 | 4,471 | 4,325 | 6,910 | |||
| Interest expense | (3,859) | (3,817) | (7,665) | (7,621) | |||
| Other income (expense), net | (2,947) | 1,830 | (4,101) | 1,337 | |||
| INCOME BEFORE INCOME TAXES | 34,851 | 14,156 | 169,038 | 37,384 | |||
| Provision for income taxes | 7,187 | 1,215 | 20,576 | 7,072 | |||
| NET INCOME | $ 27,664 | $ 12,941 | $ 148,462 | $ 30,312 | |||
| NET INCOME PER SHARE, BASIC | $ 0.15 | $ 0.07 | $ 0.80 | $ 0.17 | |||
| NET INCOME PER SHARE, DILUTED | $ 0.15 | $ 0.07 | $ 0.79 | $ 0.16 | |||
| Weighted average common shares outstanding, basic | 185,254 | 182,844 | 184,710 | 182,311 | |||
| Weighted average common shares outstanding, diluted | 187,448 | 185,427 | 191,096 | 185,089 |
| BIOMARIN PHARMACEUTICAL INC. | |||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
| Six Months Ended June 30, 2022 and 2021 | |||
| (In thousands of U.S. dollars) | |||
| (unaudited) | |||
| Six Months Ended June 30, | |||
| 2022 | 2021 | ||
| CASH FLOWS FROM OPERATING ACTIVITIES: | |||
| Net income | $ 148,462 | $ 30,312 | |
| Adjustments to reconcile net income to net cash provided by operating activities: | |||
| Depreciation and amortization | 52,614 | 55,214 | |
| Non-cash interest expense | 2,062 | 2,082 | |
| Amortization of premium on investments | 3,070 | 1,878 | |
| Stock-based compensation | 94,911 | 104,346 | |
| Gain on sale of nonfinancial assets, net | (108,000) | — | |
| Deferred income taxes | 3,455 | 1,204 | |
| Unrealized foreign exchange gain | (12,333) | (1,004) | |
| Non-cash changes in the fair value of contingent consideration | 1,338 | 4,488 | |
| Other | (18) | (376) | |
| Changes in operating assets and liabilities: | |||
| Accounts receivable, net | (92,562) | 17,420 | |
| Inventory | (1,431) | 6,379 | |
| Other current assets | (12,001) | 34,331 | |
| Other assets | 9,149 | 321 | |
| Accounts payable and other short-term liabilities | (76,345) | (60,884) | |
| Other long-term liabilities | (1,576) | 585 | |
| Net cash provided by operating activities | 10,795 | 196,296 | |
| CASH FLOWS FROM INVESTING ACTIVITIES: | |||
| Purchases of property, plant and equipment | (55,971) | (48,106) | |
| Maturities and sales of investments | 311,598 | 348,941 | |
| Purchases of investments | (304,805) | (484,572) | |
| Proceeds from sale of nonfinancial assets | 110,000 | — | |
| Purchase of intangible assets | (2,739) | (6,400) | |
| Other | — | (908) | |
| Net cash provided by (used in) investing activities | 58,083 | (191,045) | |
| CASH FLOWS FROM FINANCING ACTIVITIES: | |||
| Proceeds from exercises of awards under equity incentive plans | 29,493 | 27,640 | |
| Taxes paid related to net share settlement of equity awards | (44,377) | (38,731) | |
| Payment of contingent consideration | (21,054) | — | |
| Principal repayments of financing leases | (1,122) | (1,941) | |
| Other | — | (381) | |
| Net cash used in financing activities | (37,060) | (13,413) | |
| Effect of exchange rate changes on cash | 708 | 537 | |
| NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 32,526 | (7,625) | |
| Cash and cash equivalents: | |||
| Beginning of period | $ 587,276 | $ 649,158 | |
| End of period | $ 619,802 | $ 641,533 |
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 June 30, | Six Months Ended June 30, | Guidance (1) Year Ending | |||||||||
| 2022 | 2021 | 2022 | 2021 | December 31, 2022 | |||||||
| GAAP Net Income | $ 27.7 | $ 12.9 | $ 148.5 | $ 30.3 | $ 105.0 | to | $ 145.0 | ||||
| Interest income (expense), net | 1.4 | (0.7) | 3.3 | 0.7 | 7.0 | ||||||
| Provision for income taxes | 7.2 | 1.2 | 20.6 | 7.1 | 44.0 | ||||||
| Depreciation expense | 9.5 | 11.8 | 21.2 | 24.3 | 42.0 | ||||||
| Amortization expense | 15.6 | 15.5 | 31.2 | 30.9 | 63.0 | ||||||
| Stock-based compensation expense | 47.1 | 54.9 | 94.9 | 104.3 | 192.0 | ||||||
| Contingent consideration expense | 0.9 | 2.2 | 2.9 | 4.5 | 5.0 | ||||||
| Gain on sale of nonfinancial assets, net | — | — | (108.0) | — | (108.0) | ||||||
| Non-GAAP Income | $ 109.4 | $ 97.8 | $ 214.6 | $ 202.1 | $ 350.0 | to | $ 390.0 |
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, | |||||||||||||||
| 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 | $ 123.1 | $ — | $ (4.8) | $ 118.3 | $ 127.1 | $ — | $ (6.1) | $ 121.0 | |||||||
| Research and development | 158.2 | (5.3) | (13.6) | 139.3 | 161.1 | (7.1) | (20.8) | 133.2 | |||||||
| Selling, general and administrative | 196.8 | (4.2) | (28.7) | 163.9 | 184.2 | (4.7) | (28.0) | 151.5 | |||||||
| Intangible asset amortization and contingent consideration | 16.5 | (15.6) | (0.9) | — | 17.7 | (15.5) | (2.2) | — | |||||||
| Interest income (expense), net | (1.4) | 1.4 | — | — | 0.7 | (0.7) | — | — | |||||||
| Provision for income taxes | 7.2 | (7.2) | — | — | 1.2 | (1.2) | — | — | |||||||
| GAAP Net Income /Non-GAAP Income | $ 27.7 | $ 33.7 | $ 48.0 | $ 109.4 | $ 12.9 | $ 27.8 | $ 57.1 | $ 97.8 |
| Six Months Ended June 30, | |||||||||||||||
| 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 | $ 240.1 | $ — | $ (9.1) | $ 231.0 | $ 247.2 | $ — | $ (12.6) | $ 234.6 | |||||||
| Research and development | 319.0 | (12.7) | (30.8) | 275.5 | 309.8 | (14.6) | (38.3) | 256.9 | |||||||
| Selling, general and administrative | 391.5 | (8.5) | (55.0) | 328.0 | 358.5 | (9.7) | (53.4) | 295.4 | |||||||
| Intangible asset amortization and contingent consideration | 34.1 | (31.2) | (2.9) | — | 35.4 | (30.9) | (4.5) | — | |||||||
| Gain on sale of nonfinancial assets, net | (108.0) | — | 108.0 | — | — | — | — | — | |||||||
| Interest expense, net | (3.3) | 3.3 | — | — | (0.7) | 0.7 | — | — | |||||||
| Provision for income taxes | 20.6 | (20.6) | — | — | 7.1 | (7.1) | — | — | |||||||
| GAAP Net Income / Non-GAAP Income | $ 148.5 | $ 76.3 | $ (10.2) | $ 214.6 | $ 30.3 | $ 63.0 | $ 108.8 | $ 202.1 |
| Contact: | ||
| Investors: | Media: | |
| Traci McCarty | Debra Charlesworth | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 455-7558 | (415) 455-7451 |
SOURCE BioMarin Pharmaceutical Inc.