Full Press Release Details
SAN RAFAEL, Calif. , April 29, 2021 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
| Three Months Ended March 31, | |||||||||||
| 2021 | 2020 | % Change | |||||||||
| Total Revenues | $ | 486.0 | $ | 502.1 | (3) | % | |||||
| Net Product Revenues Marketed by BioMarin (1) | $ | 417.8 | $ | 433.3 | (4) | % | |||||
| Vimizim Net Product Revenues | $ | 158.4 | $ | 137.2 | 15 | % | |||||
| Naglazyme Net Product Revenues | $ | 107.3 | $ | 114.3 | (6) | % | |||||
| Kuvan Net Product Revenues | $ | 70.8 | $ | 122.0 | (42) | % | |||||
| Palynziq Net Product Revenues | $ | 54.0 | $ | 34.6 | 56 | % | |||||
| Brineura Net Product Revenues | $ | 27.3 | $ | 24.0 | 14 | % | |||||
| Aldurazyme Net Product Revenues | $ | 50.0 | $ | 55.7 | (10) | % | |||||
| GAAP Net Income | $ | 17.4 | $ | 81.4 | |||||||
| GAAP Net Income per Share – Basic | $ | 0.10 | $ | 0.45 | |||||||
| GAAP Net Income per Share – Diluted | $ | 0.09 | $ | 0.44 | |||||||
| Non-GAAP Income (2) | $ | 104.4 | $ | 116.5 |
| March 31, 2021 | December 31, 2020 | |||||||
| Cash, cash equivalents and investments | $ | 1,408.6 | $ | 1,350.9 |
| (1) | Net Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Kuvan, Naglazyme, Palynziq, Brineura and Firdapse, 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 9 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 will not recognize Net Product Revenues from Firdapse in the future. |
| (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 first quarter ended March 31, 2021.
Mr. Bienaimé continued, "We are well positioned to deliver strong results for the full-year 2021, and reaffirm our financial guidance provided early this year. This takes into consideration the uneven ordering patterns in our dynamic and global commercial business, as well as continued uncertainty outside of the United States from COVID-19, and further underscores the essential nature of our products to the people who rely on them. Taken together, our financial strength, including positive cash flows from operations of $113.5 million in the first quarter, combined with near-term opportunities from potential new products and a robust early-stage pipeline, we believe that 2021 will be pivotal to BioMarin's evolution."
Financial Highlights:
Commercial Portfolio (Naglazyme, VIMIZIM, Brineura, Palynziq, Kuvan and Aldurazyme)
Late-stage Regulatory Portfolio (Vosoritide 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 | 2021 Guidance * (reaffirmed) | |||||
| Total Revenues | $1,750 | to | $1,850 | |||
| Vimizim Net Product Revenues | $570 | to | $610 | |||
| Kuvan Net Product Revenues | $250 | to | $290 | |||
| Naglazyme Net Product Revenues | $365 | to | $395 | |||
| Palynziq Net Product Revenues | $210 | to | $250 | |||
| Brineura Net Product Revenues | $120 | to | $140 | |||
| Cost of Sales (% of Total Revenues) | 23% | to | 25% | |||
| Research and Development Expense | $645 | to | $695 | |||
| Selling, General and Administrative Expense | $725 | to | $775 | |||
| GAAP Net Loss | ($130) | to | ($80) | |||
| Non-GAAP Income (1) | $170 | to | $220 |
| *2021 Guidance takes into consideration ongoing expected impact from the COVID-19 pandemic in 2021 assuming consistent trends experienced during 2020. | |
| (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 page11 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 full-year 2021 financial results today, Thursday, April 29, 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: 2396463 | Conference ID: 2396463 |
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. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
| BIOMARIN PHARMACEUTICAL INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| March 31, 2021 and December 31, 2020 | |||||||
| (In thousands of U.S. dollars, except per share amounts) | |||||||
| March 31, 2021 | December 31, 2020 (1) | ||||||
| ASSETS | (unaudited) | ||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 667,313 | $ | 649,158 | |||
| Short-term investments | 420,178 | 416,228 | |||||
| Accounts receivable, net | 396,097 | 448,351 | |||||
| Inventory | 713,929 | 698,548 | |||||
| Other current assets | 91,249 | 129,934 | |||||
| Total current assets | 2,288,766 | 2,342,219 | |||||
| Noncurrent assets: | |||||||
| Long-term investments | 321,127 | 285,473 | |||||
| Property, plant and equipment, net | 1,022,474 | 1,032,471 | |||||
| Intangible assets, net | 405,903 | 417,271 | |||||
| Goodwill | 196,199 | 196,199 | |||||
| Deferred tax assets | 1,429,386 | 1,432,150 | |||||
| Other assets | 141,198 | 142,237 | |||||
| Total assets | $ | 5,805,053 | $ | 5,848,020 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 399,225 | $ | 492,548 | |||
| Short-term contingent consideration | 30,810 | — | |||||
| Total current liabilities | 430,035 | 492,548 | |||||
| Noncurrent liabilities: | |||||||
| Long-term convertible debt, net | 1,076,127 | 1,075,145 | |||||
| Long-term contingent consideration | 29,153 | 60,130 | |||||
| Other long-term liabilities | 107,728 | 114,195 | |||||
| Total liabilities | $ | 1,643,043 | $ | 1,742,018 | |||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value: 500,000,000 shares authorized; 182,670,614 and 181,740,999 shares issued and outstanding, respectively. | 183 | 182 | |||||
| Additional paid-in capital | 5,010,619 | 4,993,407 | |||||
| Company common stock held by Nonqualified Deferred Compensation Plan | (9,558) | (9,839) | |||||
| Accumulated other comprehensive income (loss) | 5,004 | (16,139) | |||||
| Accumulated deficit | (844,238) | (861,609) | |||||
| Total stockholders' equity | 4,162,010 | 4,106,002 | |||||
| Total liabilities and stockholders' equity | $ | 5,805,053 | $ | 5,848,020 |
| BIOMARIN PHARMACEUTICAL INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| Three Months Ended March 31, 2021 and 2020 | ||||||||
| (In thousands of U.S. dollars, except per share amounts) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| (unaudited) | (unaudited) | |||||||
| REVENUES: | ||||||||
| Net product revenues | $ | 467,769 | $ | 489,043 | ||||
| Royalty and other revenues | 18,261 | 13,026 | ||||||
| Total net revenues | 486,030 | 502,069 | ||||||
| OPERATING EXPENSES: | ||||||||
| Cost of sales | 120,166 | 111,374 | ||||||
| Research and development | 148,725 | 142,257 | ||||||
| Selling, general and administrative | 174,318 | 187,295 | ||||||
| Intangible asset amortization and contingent consideration | 17,735 | 15,677 | ||||||
| Gain on sale of nonfinancial assets | — | (59,495) | ||||||
| Total operating expenses | 460,944 | 397,108 | ||||||
| INCOME FROM OPERATIONS | 25,086 | 104,961 | ||||||
| Equity in the loss of BioMarin/Genzyme LLC | (1,351) | (77) | ||||||
| Interest income | 2,439 | 5,244 | ||||||
| Interest expense | (3,804) | (6,915) | ||||||
| Other income, net | 858 | (1,861) | ||||||
| INCOME BEFORE INCOME TAXES | 23,228 | 101,352 | ||||||
| Provision for income taxes | 5,857 | 19,971 | ||||||
| NET INCOME | $ | 17,371 | $ | 81,381 | ||||
| NET INCOME PER SHARE, BASIC | $ | 0.10 | $ | 0.45 | ||||
| NET INCOME PER SHARE, DILUTED | $ | 0.09 | $ | 0.44 | ||||
| Weighted average common shares outstanding, basic | 181,772 | 179,898 | ||||||
| Weighted average common shares outstanding, diluted | 184,365 | 187,163 |
| BIOMARIN PHARMACEUTICAL INC. | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||
| Three Months Ended March 31, 2021 and 2020 | |||||||
| (In thousands of U.S. dollars, except per share amounts) | |||||||
| Three Months Ended March 31, | |||||||
| 2021 | 2020 | ||||||
| (unaudited) | (unaudited) | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | |||||||
| Net income | $ | 17,371 | $ | 81,381 | |||
| Adjustments to reconcile net income to net cash used in operating activities: | |||||||
| Depreciation and amortization | 27,983 | 25,964 | |||||
| Non-cash interest expense | 1,043 | 4,618 | |||||
| Amortization of premium (accretion of discount) on investments | 673 | 60 | |||||
| Stock-based compensation | 49,503 | 46,994 | |||||
| Gain on sale of nonfinancial assets | — | (59,495) | |||||
| Deferred income taxes | 3,335 | 10,603 | |||||
| Unrealized foreign exchange loss | 3,950 | 9,400 | |||||
| Non-cash changes in the fair value of contingent consideration | 2,255 | (4) | |||||
| Other | (871) | (383) | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable, net | 40,294 | (31,898) | |||||
| Inventory | (6,425) | (20,706) | |||||
| Other current assets | 42,784 | 8,302 | |||||
| Other assets | 1,617 | (441) | |||||
| Accounts payable and accrued liabilities | (72,304) | (94,733) | |||||
| Other long-term liabilities | 2,304 | 5,144 | |||||
| Net cash provided by (used in) operating activities | 113,512 | (15,194) | |||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | |||||||
| Purchases of property, plant and equipment | (25,507) | (40,554) | |||||
| Maturities and sales of investments | 194,637 | 94,701 | |||||
| Purchases of available-for-sale securities | (237,171) | (40,104) | |||||
| Proceeds from sale of nonfinancial assets | — | 67,159 | |||||
| Purchase of intangible assets | (2,747) | (3,463) | |||||
| Other | — | (335) | |||||
| Net cash provided by (used in) investing activities | (70,788) | 77,404 | |||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | |||||||
| Proceeds from exercises of awards under equity incentive plans | 5,817 | 10,116 | |||||
| Taxes paid related to net share settlement of equity awards | (29,097) | (28,844) | |||||
| Principal repayments of financing leases | (1,084) | (943) | |||||
| Net cash used in financing activities | (24,364) | (19,671) | |||||
| Effect of exchange rate changes on cash | (205) | (3,353) | |||||
| NET INCREASE IN CASH AND CASH EQUIVALENTS | $ | 18,155 | $ | 39,186 | |||
| Cash and cash equivalents: | |||||||
| Beginning of period | $ | 649,158 | $ | 437,446 | |||
| End of period | $ | 667,313 | $ | 476,632 |
The following table presents Net Product Revenues by Product:
| Net Product Revenues by Product | ||||||||||
| (In millions of U.S. dollars) | ||||||||||
| Three Months Ended March 31, | ||||||||||
| 2021 | 2020 | % Change | ||||||||
| (unaudited) | (unaudited) | |||||||||
| PKU franchise | $ | 124.8 | $ | 156.6 | (20) | % | ||||
| Vimizim | 158.4 | 137.2 | 15 | % | ||||||
| Naglazyme | 107.3 | 114.3 | (6) | % | ||||||
| Brineura | 27.3 | 24.0 | 14 | % | ||||||
| Firdapse (1) | — | 1.2 | (100) | % | ||||||
| Net Product Revenues Marketed by BioMarin | $ | 417.8 | $ | 433.3 | ||||||
| Aldurazyme Net Product Revenues Marketed by Genzyme | 50.0 | 55.7 | (10) | % | ||||||
| Total Net Product Revenues | $ | 467.8 | $ | 489.0 |
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 March 31, | |||||||||||
| 2021 | 2020 | % Change | |||||||||
| (unaudited) | (unaudited) | ||||||||||
| Kuvan | $ | 70.8 | $ | 122.0 | (42) | % | |||||
| Palynziq | 54.0 | 34.6 | 56 | % | |||||||
| Total PKU franchise | $ | 124.8 | $ | 156.6 | (20) | % |
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 March 31, | Guidance Year Ending | |||||||||||||||
| 2021 | 2020 | December 31, 2021 | ||||||||||||||
| GAAP Net Income (Loss) | $ | 17.4 | $ | 81.4 | $ | (130.0) | — | $ | (80.0) | |||||||
| Interest expense, net | 1.4 | 1.7 | 11.0 | — | 11.0 | |||||||||||
| Provision for income taxes | 5.9 | 20.0 | (16.0) | — | (16.0) | |||||||||||
| Depreciation expense | 12.5 | 10.3 | 48.0 | — | 48.0 | |||||||||||
| Amortization expense | 15.4 | 15.7 | 62.0 | — | 62.0 | |||||||||||
| Stock-based compensation expense | 49.5 | 46.9 | 186.0 | — | 186.0 | |||||||||||
| Contingent consideration expense | 2.3 | — | 9.0 | — | 9.0 | |||||||||||
| Gain on sale of nonfinancial assets | — | (59.5) | — | — | — | |||||||||||
| Non-GAAP Income | $ | 104.4 | $ | 116.5 | $ | 170.0 | — | $ | 220.0 |
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 March 31, | |||||||||||||||||||||||||||||||
| 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 | $ | 120.2 | $ | — | $ | (6.5) | $ | 113.7 | $ | 111.4 | $ | — | $ | (5.1) | $ | 106.3 | |||||||||||||||
| Research and development | 148.7 | (7.5) | (17.5) | 123.7 | 142.3 | (4.8) | (13.7) | 123.8 | |||||||||||||||||||||||
| Selling, general and administrative | 174.3 | (5.0) | (25.5) | 143.8 | 187.3 | (5.5) | (28.1) | 153.7 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration | 17.7 | (15.4) | (2.3) | — | 15.7 | (15.7) | 0.0 | — | |||||||||||||||||||||||
| Gain on sale of nonfinancial assets | 0.0 | — | — | — | (59.5) | — | 59.5 | — | |||||||||||||||||||||||
| Interest expense, net | (1.4) | 1.4 | — | — | (1.7) | 1.7 | — | — | |||||||||||||||||||||||
| Provision for income taxes | 5.9 | (5.9) | — | — | 20.0 | (20.0) | — | — | |||||||||||||||||||||||
| GAAP Net Income / Non-GAAP Income | $ | 17.4 | $ | 35.2 | $ | 51.8 | $ | 104.4 | $ | 81.4 | $ | 47.7 | $ | (12.6) | $ | 116.5 |
| Contact: | ||
| Investors: | Media: | |
| Traci McCarty | Debra Charlesworth | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 455-7558 | (415) 455-7451 |
SOURCE BioMarin Pharmaceutical Inc.