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First Quarter 2025 Total Revenues of $745 million (+15% Y/Y and +17% at Constant Currency Y/Y)
First Quarter 2025 GAAP Diluted Earnings Per Share (EPS) of $0.95 (+107% Y/Y)
First Quarter 2025 Non-GAAP Diluted EPS of $1.13 (+59% Y/Y)
Conference Call and Webcast Scheduled Today at 4:30 p.m. ET
SAN RAFAEL, Calif., May 1, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced financial results for the first quarter ended March 31, 2025.
"During the first quarter, we saw continued high demand for our innovative medicines resulting in strong revenue growth and profitability," said Alexander Hardy, President and Chief Executive Officer of BioMarin. "Products in our pipeline also advanced according to plan. In April, we shared positive top-line results from the Phase 3 PALYNZIQ® study for the treatment of adolescents with phenylketonuria between the ages of 12 and 17. Also in April, we were pleased to conclude enrollment in the pivotal study in hypochondroplasia with VOXZOGO, keeping us on track to launch in 2027, should data be supportive."
Mr. Hardy continued, "For the remainder of 2025, we look forward to continued momentum in our global expansion of VOXZOGO® for achondroplasia. Across our Enzyme Therapies, we plan to build upon strong PALYNZIQ performance in the quarter, as well as initiatives to drive uptake of our other therapies to reach an even greater number of patients around the world. In addition to our strong financial outlook, we expect to advance multiple new indications with VOXZOGO in our CANOPY clinical program, share early clinical results from both BMN 351 for Duchenne Muscular dystrophy and BMN 333, our long-acting C-type natriuretic peptide, as well as execute on our business development strategy. We are delivering strong growth and profitability while we continue to implement BioMarin's new strategy and operating model. We look forward to seeing the benefits of this transformation flow through our results in the coming quarters and beyond."
First Quarter 2025 Financial Highlights
First Quarter 2025 Business Highlights
Innovation
Growth
Value Commitment
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) | ||||||
Three Months Ended March 31, | ||||||
2025 | 2024 | % Change | ||||
Total Revenues | $745 | $649 | 15 % | |||
Net Product Revenues by Product: | ||||||
VOXZOGO | $214 | $153 | 40 % | |||
Enzyme Therapies: | ||||||
VIMIZIM | $188 | $193 | (3) % | |||
NAGLAZYME | 114 | 106 | 8 % | |||
PALYNZIQ | 93 | 76 | 22 % | |||
ALDURAZYME | 49 | 35 | 40 % | |||
BRINEURA | 40 | 39 | 3 % | |||
Total Enzyme Therapies Revenue | $484 | $449 | 8 % | |||
KUVAN | $25 | $36 | (31) % | |||
ROCTAVIAN® | $11 | $1 | 1,000 % | |||
GAAP Net Income | $186 | $89 | 109 % | |||
Non-GAAP Income (1) | $221 | $140 | 58 % | |||
GAAP Operating Margin % (2) | 30.0 % | 13.6 % | ||||
Non-GAAP Operating Margin % (1) | 35.7 % | 23.8 % | ||||
GAAP Diluted Earnings per Share (EPS) | $0.95 | $0.46 | 107 % | |||
Non-GAAP Diluted EPS (1) | $1.13 | $0.71 | 59 % |
March 31, | December 31, | ||
Total cash, cash equivalents & investments | $ 1,779 | $ 1,659 |
(1) | Refer to Non-GAAP Information beginning on page 10 of this press release for definitions of Non-GAAP Income, Non-GAAP Operating Margin percentage and Non-GAAP Diluted EPS along with the related reconciliations to the comparable information reported under U.S. GAAP. |
(2) | GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations divided by Total Revenues. |
Forward-Looking Non-GAAP Financial Information
BioMarin does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the company is unable to predict with reasonable certainty the financial impact of changes resulting from its strategic portfolio and business operating model reviews; potential future asset impairments; gains and losses on investments; and other unusual gains and losses without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. As such, any reconciliations provided would imply a degree of precision that could be confusing or misleading to investors.
2025 Full-Year Financial Guidance (in millions, except % and EPS amounts)
Item | 2025 Guidance Reaffirmed | |||||
Total Revenues (1) | $3,100 | to | $3,200 | |||
Non-GAAP Operating Margin % (2) | 32 % | to | 33 % | |||
Non-GAAP Diluted EPS (2)(3) | $4.20 | to | $4.40 |
(1) | VOXZOGO contribution to full-year 2025 Total Revenues expected to be in the range of $900 million to $950 million. |
(2) | Refer to Non-GAAP Information beginning on page 10 of this press release for definitions of Non-GAAP Operating Margin and Non-GAAP Diluted EPS. |
(3) | Non-GAAP Diluted EPS guidance assumes approximately 200 million Weighted-Average Diluted Shares Outstanding. |
BioMarin will host a conference call and webcast to discuss first quarter 2025 financial results today, Thursday, May 1, 2025, 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: 888-596-4144 | Replay Dial-in Number: 800-770-2030 |
International Dial-in Number: 646-968-2525 | Replay International Dial-in Number: 609-800-9909 |
Conference ID: 4327591 | Conference ID: 4327591 |
About BioMarin
BioMarin is a global biotechnology company dedicated to translating the promise of genetic discovery into medicines that make a profound impact on the life of each patient. The San Rafael, California-based company, founded in 1997, has a proven track record of innovation with eight commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin pursues treatments that offer new possibilities for patients and families around the world navigating rare or difficult to treat genetic conditions. To learn more, please visit www.biomarin.com.
Forward-Looking Statements
This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: future financial performance, including the expectations of Total Revenues, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS and Operating Cash Flow for, in certain instances, the full-year 2025 and future periods, as well as profitability growth in 2025, and the underlying drivers of those results, such as the revenue opportunity represented by treatments for Skeletal Conditions, namely VOXZOGO, the expected demand and continued growth of BioMarin's Enzyme Therapies portfolio, including PALYNZIQ, and the expectation regarding the full realization of the benefits of BioMarin's cost transformation program; plans regarding BioMarin's revamped corporate strategy and operating model in 2025 and beyond, including expected growth in the Skeletal Conditions business unit and execution of BioMarin's business development strategy, and its anticipated benefits; the timing of orders for commercial products; BioMarin's ability to meet product demand; the timing of BioMarin's clinical development and commercial prospects, including announcements of data from clinical studies and trials; the clinical development and commercialization of BioMarin's product candidates and commercial products, including (i) expected advancements of pipeline candidates, including BMN 333, BMN 349 and BMN 351, the anticipated initial data read-out for BMN 351 in the second half of 2025, the expected data and data presentation for BMN 333 in the first half of 2026 and plans to initiate a registration-enabling study for BMN 333 in 2026, as well as plans to seek similar agreements with additional global regulators in the coming months; (ii) plans to submit applications to expand PALYNZIQ age eligibility for the treatment of adolescents with phenylketonuria between the ages of 12 and 17 in the U.S. and Europe in the second half of 2025; (iii) expected topline data from the pivotal study in hypochondroplasia in 2026 and launch in 2027; (iv) the expectations regarding global expansion of VOXZOGO for achondroplasia and expected increase in the rate of U.S. expansion in the second half of 2025; (v) plans to advance five new VOXZOGO indications with BioMarin's CANOPY clinical program; and (vi) plans to reach greater number of patients around the world across BioMarin's Enzyme Therapies; the expected benefits and availability of BioMarin's commercial products and product candidates; and potential growth opportunities and trends.
These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: BioMarin's success in the commercialization of its commercial products; impacts of macroeconomic and other external factors on BioMarin's operations, such as trade wars and potential future pharmaceutical tariffs; results and timing of current and planned preclinical studies and clinical trials and the release of data from those trials; BioMarin's ability to successfully manufacture its commercial products and product candidates; the content and timing of decisions by the U.S. Food and Drug Administration, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products; actual sales of BioMarin's commercial products; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
BioMarin®, BRINEURA®, KUVAN®, NAGLAZYME®, PALYNZIQ®, ROCTAVIAN®, 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.
Contact: | ||
Investors: | Media: | |
Traci McCarty | Marni Kottle | |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
(415) 455-7558 | (650) 374-2803 |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||
Three Months Ended March 31, 2025 and 2024 | |||
(In thousands of U.S. dollars, except per share amounts) | |||
(Unaudited) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
REVENUES: | |||
Net product revenues | $ 734,644 | $ 637,815 | |
Royalty and other revenues | 10,501 | 11,018 | |
Total revenues | 745,145 | 648,833 | |
OPERATING EXPENSES: | |||
Cost of sales | 151,558 | 125,180 | |
Research and development | 158,731 | 204,987 | |
Selling, general and administrative | 206,116 | 225,906 | |
Intangible asset amortization | 4,847 | 14,298 | |
Gain on sale of nonfinancial assets | — | (10,000) | |
Total operating expenses | 521,252 | 560,371 | |
INCOME FROM OPERATIONS | 223,893 | 88,462 | |
Interest income | 19,013 | 19,365 | |
Interest expense | (2,863) | (3,547) | |
Other income (expense), net | (1,954) | 1,267 | |
INCOME BEFORE INCOME TAXES | 238,089 | 105,547 | |
Provision for income taxes | 52,403 | 16,885 | |
NET INCOME | $ 185,686 | $ 88,662 | |
EARNINGS PER SHARE, BASIC | $ 0.97 | $ 0.47 | |
EARNINGS PER SHARE, DILUTED | $ 0.95 | $ 0.46 | |
Weighted average common shares outstanding, basic | 190,967 | 188,866 | |
Weighted average common shares outstanding, diluted | 196,474 | 199,262 |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
March 31, 2025 and 2024 | |||
(In thousands of U.S. dollars, except per share amounts) | |||
(Unaudited) | |||
March 31, 2025 | December 31, 2024 ⁽¹⁾ | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 1,048,803 | $ 942,842 | |
Short-term investments | 223,532 | 194,864 | |
Accounts receivable, net | 739,177 | 660,535 | |
Inventory | 1,274,848 | 1,232,653 | |
Other current assets | 181,545 | 201,533 | |
Total current assets | 3,467,905 | 3,232,427 | |
Noncurrent assets: | |||
Long-term investments | 506,724 | 521,238 | |
Property, plant and equipment, net | 1,032,613 | 1,043,041 | |
Intangible assets, net | 247,346 | 255,278 | |
Goodwill | 196,199 | 196,199 | |
Deferred tax assets | 1,460,566 | 1,489,366 | |
Other assets | 235,654 | 251,391 | |
Total assets | $ 7,147,007 | $ 6,988,940 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable and accrued liabilities | $ 628,213 | $ 606,988 | |
Total current liabilities | 628,213 | 606,988 | |
Noncurrent liabilities: | |||
Long-term convertible debt, net | 595,650 | 595,138 | |
Other long-term liabilities | 129,685 | 128,824 | |
Total liabilities | 1,353,548 | 1,330,950 | |
Stockholders' equity: | |||
Common stock, $0.001 par value: 500,000,000 shares authorized; 191,755,802 and 190,761,349 shares issued and outstanding, respectively | 192 | 191 | |
Additional paid-in capital | 5,794,302 | 5,802,068 | |
Company common stock held by the Nonqualified Deferred Compensation Plan | (11,177) | (11,227) | |
Accumulated other comprehensive income (loss) | 19,151 | 61,653 | |
Accumulated deficit | (9,009) | (194,695) | |
Total stockholders' equity | 5,793,459 | 5,657,990 | |
Total liabilities and stockholders' equity | $ 7,147,007 | $ 6,988,940 | |
(1) | December 31, 2024 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, 2024, filed with the SEC on February 24, 2025. |
BIOMARIN PHARMACEUTICAL INC. | |||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | |||
Three Months Ended March 31, 2025 and 2024 | |||
(In thousands of U.S. dollars) | |||
(Unaudited) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | |||
Net income | $ 185,686 | $ 88,662 | |
Adjustments to reconcile net income to net cash provided by operating activities: | |||
Depreciation and amortization | 22,069 | 27,350 | |
Non-cash interest expense | 660 | 990 | |
Accretion of discount on investments | (1,362) | (2,502) | |
Stock-based compensation | 37,700 | 58,249 | |
Gain on sale of nonfinancial assets | — | (10,000) | |
Impairment of assets | 2,967 | — | |
Deferred income taxes | 28,429 | 285 | |
Unrealized foreign exchange gain | (10,026) | (10,804) | |
Other | (1,267) | 127 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (57,590) | (3,386) | |
Inventory | (24,335) | (16,820) | |
Other current assets | (6,327) | (17,353) | |
Other assets | (1,624) | (12,130) | |
Accounts payable and accrued liabilities | (2,655) | (59,006) | |
Other long-term liabilities | 2,069 | 3,309 | |
Net cash provided by operating activities | 174,394 | 46,971 | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |||
Purchases of property, plant and equipment | (16,768) | (26,104) | |
Maturities and sales of investments | 77,804 | 131,533 | |
Purchases of investments | (89,274) | (121,665) | |
Proceeds from sale of nonfinancial assets | — | 10,000 | |
Purchase of intangible assets | — | (8,000) | |
Net cash used in investing activities | (28,238) | (14,236) | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |||
Proceeds from exercises of awards under equity incentive plans | — | 7,197 | |
Taxes paid related to net share settlement of equity awards | (38,779) | (49,948) | |
Other | — | (42) | |
Net cash used in financing activities | (38,779) | (42,793) | |
Effect of exchange rate changes on cash | (1,416) | 1,927 | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 105,961 | (8,131) | |
Cash and cash equivalents: | |||
Beginning of period | $ 942,842 | $ 755,127 | |
End of period | $ 1,048,803 | $ 746,996 |
Non-GAAP Information
The results presented in this press release include both GAAP information and Non-GAAP information. Non-GAAP Income is defined by the company as GAAP Net Income excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items, as detailed below when applicable. The company also includes a Non-GAAP adjustment for the estimated tax impact of the reconciling items. Non-GAAP R&D expenses and Non-GAAP SG&A expenses are defined by the company as GAAP R&D expenses and GAAP SG&A expenses, respectively, excluding stock-based compensation expense and, in certain periods, certain other specified items, as detailed below when applicable. Non-GAAP Operating Margin percentage is defined by the company as GAAP Income from Operations, excluding amortization of intangible assets, stock-based compensation expense and, in certain periods, certain other specified items, divided by GAAP Total Revenues. Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income divided by Non-GAAP Weighted-Average Diluted Shares Outstanding. Non-GAAP Weighted-Average Diluted Shares Outstanding is defined by the company as GAAP Weighted-Average Diluted Shares Outstanding, adjusted to include any common shares issuable under the company's equity plans and convertible debt in periods when they are dilutive under Non-GAAP. The company's presentation of percentage changes in total revenues at Constant Currency rates, which is computed using current period local currency sales at the prior period's foreign exchange rates, is also a Non-GAAP financial measure. This measure provides information about growth (or declines) in the company's total revenue as if foreign currency exchange rates had not changed between the prior period and the current period.
BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities: the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income, Non-GAAP R&D expenses, Non-GAAP SG&A expenses, Non-GAAP Operating Margin percentage, Non-GAAP Diluted EPS, Non-GAAP Weighted-Average Diluted Shares Outstanding and Constant Currency are important internal measurements for BioMarin, the company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the company's results from period to period and to its forward-looking guidance, and to identify operating trends in the company's principal business. BioMarin also uses Non-GAAP Income internally to understand, manage and evaluate its business and to make operating decisions, and compensation of executives is based in part on this measure.
Non-GAAP financial measures are not meant to be considered in isolation or 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 financial 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 financial measures; likewise, the company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP financial measures. Because of the non-standardized definitions, the Non-GAAP financial 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 tables present the reconciliation of GAAP reported to Non-GAAP adjusted financial information:
Reconciliation of GAAP Reported Information to Non-GAAP Information (1) | |||
(In millions of U.S. dollars, except per share data) | |||
(unaudited) | |||
Three Months Ended March 31, | |||
2025 | 2024 | ||
GAAP Reported Net Income | $ 186 | $ 89 | |
Adjustments | |||
Stock-based compensation expense - COS | 2 | 3 | |
Stock-based compensation expense - R&D | 12 | 21 | |
Stock-based compensation expense - SG&A | 23 | 34 | |
Amortization of intangible assets | 5 | 14 | |
Gain on sale of nonfinancial assets (2) | — | (10) | |
Severance and restructuring costs (3) | — | 3 | |
Loss on investments (4) | 3 | — | |
Income tax effect of adjustments | (10) | (15) | |
Non-GAAP Income | $ 221 | $ 140 |
Three Months Ended March 31, | |||||||
2025 | 2024 | ||||||
Dollar | Percentage | Dollar | Percentage | ||||
GAAP Change in Total Revenues | $ 96 | 15 % | $ 52 | 9 % | |||
Adjustment for unfavorable impact of foreign currency exchange rates on product sales denominated in currencies other than U.S. dollars | 14 | 23 | |||||
Non-GAAP change in Total Revenues at Constant Currency | $ 110 | 17 % | $ 75 | 13 % |
Three Months Ended March 31, | |||||||
2025 | 2024 | ||||||
R&D | SG&A | R&D | SG&A | ||||
GAAP expenses | $ 159 | $ 206 | $ 205 | $ 226 | |||
Adjustments | |||||||
Stock-based compensation expense | (12) | (23) | (21) | (34) | |||
Severance and restructuring costs (3) | — | — | — | (3) | |||
Non-GAAP expenses | $ 147 | $ 183 | $ 184 | $ 188 |
Three Months Ended March 31, | ||||
2025 | Percent | 2024 | Percent | |
GAAP Income from Operations | $ 224 | 30.0 % | $ 88 | 13.6 % |
Adjustments | ||||
Stock-based compensation expense | 37 | 5.0 | 58 | 9.0 |
Amortization of intangible assets | 5 | 0.7 | 14 | 2.2 |
Gain on sale of nonfinancial assets (2) | — | — | (10) | (1.5) |
Severance and restructuring costs (3) | — | — | 3 | 0.5 |
Non-GAAP Income from Operations | $ 266 | 35.7 % | $ 154 | 23.8 % |
Three Months Ended March 31, | |||
2025 | 2024 | ||
GAAP Diluted EPS | $ 0.95 | $ 0.46 | |
Adjustments | |||
Stock-based compensation expense | 0.19 | 0.29 | |
Amortization of intangible assets | 0.03 | 0.07 | |
Gain on sale of nonfinancial assets (2) | — | (0.05) | |
Severance and restructuring costs (3) | — | 0.02 | |
Loss on investments (4) | 0.02 | — | |
Income tax effect of adjustments | (0.05) | (0.08) | |
Non-GAAP Diluted EPS (5) | $ 1.13 | $ 0.71 |
(1) | Certain amounts may not sum or recalculate due to rounding. |
(2) | Represents a payment triggered by a third party's attainment of a regulatory approval milestone related to previously sold intangible assets. |
(3) | These amounts were included in SG&A and represent severance and restructuring costs related to the Company's 2024 corporate initiatives and the associated organizational redesign efforts. |
(4) | Represents an impairment loss on non-marketable equity securities recorded in Other income (expense), net. |
(5) | Non-GAAP Weighted-Average Diluted Shares Outstanding were 196.5 million and 199.3 million shares for the three months ended March 31, 2025 and 2024, respectively, which were equal to the respective GAAP Weighted-Average Diluted Shares Outstanding in the periods presented. |
SOURCE BioMarin Pharmaceutical Inc.
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