Full Press Release Details
SAN RAFAEL, Calif. , April 29, 2020 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
| Three Months Ended March 31, | ||||||||||
| 2020 | 2019 | % Change | ||||||||
| Total Revenues | $ | 502.1 | $ | 400.7 | 25 | % | ||||
| Net Product Revenues Marketed by BioMarin (1) | 433.3 | 349.2 | 24 | % | ||||||
| Vimizim Net Product Revenues | 137.2 | 125.8 | 9 | % | ||||||
| Kuvan Net Product Revenues | 122.0 | 106.9 | 14 | % | ||||||
| Naglazyme Net Product Revenues | 114.3 | 86.9 | 32 | % | ||||||
| Palynziq Net Product Revenues | 34.6 | 12.3 | 181 | % | ||||||
| Brineura Net Product Revenues | 24.0 | 12.2 | 97 | % | ||||||
| Aldurazyme Net Product Revenues | 55.7 | 45.3 | 23 | % | ||||||
| GAAP Net Income (Loss) | $ | 81.4 | $ | (56.5) | ||||||
| GAAP Net Income (Loss) per Share – Basic | $ | 0.45 | $ | (0.32) | ||||||
| GAAP Net Income (Loss) per Share – Diluted | $ | 0.44 | $ | (0.32) | ||||||
| Non-GAAP Income (2) | $ | 116.5 | $ | 24.8 |
| March 31, 2020 | December 31, 2019 | |||||||
| Cash, cash equivalents and investments | $ | 1,149.2 | $ | 1,165.8 |
| (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, including Firdapse. In January 2020, BioMarin divested the Firdapse assets to a third party in a sale transaction. The sale will be reflected in the Company's consolidated financial statements for the three months ending 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, 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 10 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, 2020.
Total Revenues increased 25% to $502.1 million . The increase in Total Revenues was primarily attributed to increased Net Product Revenues which were $489.0 million in the first quarter of 2020, compared to $394.5 million for the first quarter of 2019. The increase in Net Product Revenues was attributed to the following:
The increase in GAAP Net Income for the first quarter of 2020, compared to GAAP Net Loss for the same period in 2019 was primarily due to the following:
Non-GAAP Income for the first quarter of 2020 increased to $116.5 million , compared to Non-GAAP Income of $24.8 million for the same period in 2019. The increase in Non-GAAP Income for the quarter, compared to the same period in 2019, was attributed to higher gross profit and decreased R&D expense, partially offset by higher SG&A expense.
As of March 31, 2020, BioMarin had cash, cash equivalents and investments totaling approximately $1.1 billion , as compared to $1.2 billion on December 31, 2019.
Mr. Bienaimé continued, "Based on positive interactions with U.S. and European regulatory authorities in the quarter, we plan to submit marketing applications in both regions for vosoritide to treat children with achondroplasia in the third quarter of this year. Our multi-pronged dossier of data encompasses long-term clinical results in 5 to 18 year-olds, natural history data, the ongoing study of newborns through 5 years, and highly statistically significant placebo-controlled Phase 3 results. The positive and significant results from our vosoritide clinical programs have led us to believe that this potential drug could be the first pharmacological treatment for the underlying cause of achondroplasia. Interest in our clinical studies with vosoritide has been extremely robust, demonstrating that families are keen to seek early treatment for their children."
Mr. Bienaimé concluded, "2020 is expected to be a transformational year for BioMarin, despite impact from COVID-19 in the near-term. The agility demonstrated by BioMarin employees in the face of this global pandemic has enabled the continued supply of our essential medicines to the patients who need them. And while we expect minor financial impact in the near-term, our business is well-positioned to weather such challenges. Our first quarter revenue growth and improvement in profitability support our belief that 2020 continues to look poised to be one of our most significant value-creating years to date."
2020 Full-Year Financial Guidance
Due to the uncertainty surrounding the COVID-19 pandemic and the potential impact on its business, BioMarin is reducing its guidance for Total Revenues and Net Product Revenues for Vimizim, Naglazyme and Palynziq for 2020.
| Item | Provided February 26, 2020 | Updated April 29, 2020 | ||||||||||||
| Total Revenues (1) | $1,950 | to | $2,050 | $1,850 | to | $1,950 | ||||||||
| Vimizim Net Product Revenues | $560 | to | $610 | $530 | to | $570 | ||||||||
| Kuvan Net Product Revenues | $430 | to | $480 | Unchanged | ||||||||||
| Naglazyme Net Product Revenues | $380 | to | $420 | $360 | to | $400 | ||||||||
| Palynziq Net Product Revenues | $180 | to | $210 | $160 | to | $190 | ||||||||
| Brineura Net Product Revenues | $85 | to | $115 | Unchanged | ||||||||||
| Cost of Sales (% of Total Revenues) | 20 | % | to | 21 | % | Unchanged | ||||||||
| Research and Development Expense | $675 | to | $725 | Unchanged | ||||||||||
| Selling, General and Administrative Expense | $780 | to | $830 | Unchanged | ||||||||||
| GAAP Net Income (2) | $20 | to | $80 | Unchanged | ||||||||||
| Non-GAAP Income (3) | $260 | to | $310 | Unchanged |
| (1) | Updated Revenue guidance reflects BioMarin's projected impact of the COVID-19 pandemic on its global revenue sources, mostly in the form of demand interruptions such as missed patient infusions and delayed treatment starts for new patients. The updated revenue guidance assumes stabilization of such interruptions in the second half of 2020. |
| (2) | 2020 GAAP Net Income guidance does not reflect the potential impact on non-cash GAAP income tax associated with the tax effects of potential intra-entity intangible asset transfers between BioMarin entities as a result of changing international tax laws. Any such changes, if implemented, are not expected to have an impact on operations or cash flows in 2020 but may have an impact on GAAP Net Income in the form of an income tax benefit of potentially greater than $500 million. |
| (3) | All Financial Guidance items are calculated based on U.S. GAAP with the exception of Non-GAAP Income/Loss. Refer to Non-GAAP Information beginning on page 10 of this press release for a complete discussion of the Company's Non-GAAP financial information and reconciliations to the corresponding GAAP reported information. |
Key Program Highlights
BioMarin will host a conference call and webcast to discuss first quarter 2020 financial results today, Wednesday, April 29, 2020 at 4:15 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: 833.360.0852 | Replay Dial-in Number: 855.859.2056 |
| International Dial-in Number: 630.652.5841 | Replay International Dial-in Number: 404.537.3406 |
| Conference ID: 6194595 | Conference ID: 6194595 |
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, 2020 and December 31, 2019 | |||||||
| (In thousands of U.S. dollars, except per share amounts) | |||||||
| March 31, 2020 | December 31, 2019 (1) | ||||||
| ASSETS | (unaudited) | ||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 476,632 | $ | 437,446 | |||
| Short-term investments | 381,764 | 316,361 | |||||
| Accounts receivable, net | 396,384 | 377,404 | |||||
| Inventory | 705,652 | 680,275 | |||||
| Other current assets | 155,817 | 130,657 | |||||
| Total current assets | 2,116,249 | 1,942,143 | |||||
| Noncurrent assets: | |||||||
| Long-term investments | 290,796 | 411,978 | |||||
| Property, plant and equipment, net | 1,009,972 | 1,010,868 | |||||
| Intangible assets, net | 443,717 | 456,580 | |||||
| Goodwill | 196,199 | 197,039 | |||||
| Deferred tax assets | 539,990 | 549,422 | |||||
| Other assets | 125,918 | 122,009 | |||||
| Total assets | $ | 4,722,841 | $ | 4,690,039 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued liabilities | $ | 454,506 | $ | 570,621 | |||
| Short-term convertible debt, net | 365,964 | 361,882 | |||||
| Total current liabilities | 820,470 | 932,503 | |||||
| Noncurrent liabilities: | |||||||
| Long-term convertible debt, net | 486,713 | 486,238 | |||||
| Long-term contingent consideration | 50,524 | 50,793 | |||||
| Other long-term liabilities | 125,172 | 98,124 | |||||
| Total liabilities | $ | 1,482,879 | $ | 1,567,658 | |||
| Stockholders' equity: | |||||||
| Common stock, $0.001 par value: 500,000,000 shares authorized; 180,761,969 and 179,838,114 shares issued and outstanding, respectively. | 181 | 180 | |||||
| Additional paid-in capital | 4,854,814 | 4,832,707 | |||||
| Company common stock held by Nonqualified Deferred Compensation Plan | (9,832) | (9,961) | |||||
| Accumulated other comprehensive income | 34,127 | 20,164 | |||||
| Accumulated deficit | (1,639,328) | (1,720,709) | |||||
| Total stockholders' equity | 3,239,962 | 3,122,381 | |||||
| Total liabilities and stockholders' equity | $ | 4,722,841 | $ | 4,690,039 |
| BIOMARIN PHARMACEUTICAL INC. | |||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
| Three Months Ended March 31, 2020 and 2019 | |||||||
| (In thousands of U.S. dollars, except per share amounts) | |||||||
| Three Months Ended March 31, | |||||||
| 2020 | 2019 | ||||||
| (unaudited) | (unaudited) | ||||||
| REVENUES: | |||||||
| Net product revenues | $ | 489,043 | $ | 394,483 | |||
| Royalty and other revenues | 13,026 | 6,262 | |||||
| Total net revenues | 502,069 | 400,745 | |||||
| OPERATING EXPENSES: | |||||||
| Cost of sales | 111,374 | 89,182 | |||||
| Research and development | 142,257 | 183,591 | |||||
| Selling, general and administrative | 187,295 | 162,158 | |||||
| Intangible asset amortization and contingent consideration | 15,677 | 19,765 | |||||
| Gain on sale of nonfinancial assets | (59,495) | — | |||||
| Total operating expenses | 397,108 | 454,696 | |||||
| INCOME (LOSS) FROM OPERATIONS | 104,961 | (53,951) | |||||
| Equity in the loss of BioMarin/Genzyme LLC | (77) | (185) | |||||
| Interest income | 5,244 | 6,298 | |||||
| Interest expense | (6,915) | (6,727) | |||||
| Other income, net | (1,861) | 1,608 | |||||
| INCOME (LOSS) BEFORE INCOME TAXES | 101,352 | (52,957) | |||||
| Provision for income taxes | 19,971 | 3,516 | |||||
| NET INCOME (LOSS) | 81,381 | (56,473) | |||||
| NET INCOME (LOSS) PER SHARE, BASIC | $ | 0.45 | $ | (0.32) | |||
| NET INCOME (LOSS) PER SHARE, DILUTED | $ | 0.44 | $ | (0.32) | |||
| Weighted average common shares outstanding, basic | 179,898 | 178,271 | |||||
| Weighted average common shares outstanding, diluted | 187,163 | 178,271 |
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, | ||||||||||
| 2020 | 2019 | % Change | ||||||||
| (unaudited) | (unaudited) | |||||||||
| Brineura | $ | 24.0 | $ | 12.2 | 97 | % | ||||
| Firdapse (1) | 1.2 | 5.1 | (76) | % | ||||||
| Naglazyme | 114.3 | 86.9 | 32 | % | ||||||
| PKU franchise | 156.6 | 119.2 | 31 | % | ||||||
| Vimizim | 137.2 | 125.8 | 9 | % | ||||||
| Net Product Revenues Marketed by BioMarin | 433.3 | 349.2 | ||||||||
| Aldurazyme Net Product Revenues Marketed by Genzyme | 55.7 | 45.3 | 23 | % | ||||||
| Total Net Product Revenues | $ | 489.0 | $ | 394.5 |
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) | ||||||||||
| (unaudited) | ||||||||||
| Three Months Ended March 31, | ||||||||||
| 2020 | 2019 | % Change | ||||||||
| (unaudited) | (unaudited) | |||||||||
| Kuvan | $ | 122.0 | 106.9 | 14 | % | |||||
| Palynziq | 34.6 | 12.3 | 181 | % | ||||||
| Total PKU franchise | $ | 156.6 | $ | 119.2 | 31 | % |
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 (benefit from) 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 | ||||||||||||||||
| 2020 | 2019 | December 31, 2020 | |||||||||||||||
| GAAP Net Income (Loss) | $ | 81.4 | $ | (56.5) | $ | 20.0 | — | $ | 80.0 | ||||||||
| Interest expense, net | 1.7 | 0.4 | 3.0 | — | 2.0 | ||||||||||||
| Provision for income taxes | 20.0 | 3.5 | 4.5 | — | 10.5 | ||||||||||||
| Depreciation expense | 10.3 | 14.9 | 50.0 | — | 47.0 | ||||||||||||
| Amortization expense | 15.7 | 7.5 | 63.0 | — | 61.0 | ||||||||||||
| Stock-based compensation expense | 46.9 | 42.7 | 177.0 | — | 167.0 | ||||||||||||
| Contingent consideration expense | — | 12.3 | 2.0 | — | 2.0 | ||||||||||||
| Gain on sale of nonfinancial assets | (59.5) | — | (59.5) | — | (59.5) | ||||||||||||
| Non-GAAP Income | $ | 116.5 | $ | 24.8 | $ | 260.0 | — | $ | 310.0 |
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, | |||||||||||||||||||||||||||||||
| 2020 | 2019 | ||||||||||||||||||||||||||||||
| 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 | $ | 111.4 | $ | — | $ | (5.1) | $ | 106.3 | $ | 89.2 | $ | — | $ | (4.8) | $ | 84.4 | |||||||||||||||
| Research and development | 142.3 | (4.8) | (13.7) | 123.8 | 183.6 | (9.3) | (13.8) | 160.5 | |||||||||||||||||||||||
| Selling, general and administrative | 187.3 | (5.5) | (28.1) | 153.7 | 162.2 | (5.6) | (24.1) | 132.5 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration | 15.7 | (15.7) | — | — | 19.8 | (7.5) | (12.3) | — | |||||||||||||||||||||||
| Gain on sale of nonfinancial assets | (59.5) | — | 59.5 | — | — | — | — | — | |||||||||||||||||||||||
| Interest expense, net | (1.7) | 1.7 | — | — | (0.4) | 0.4 | — | — | |||||||||||||||||||||||
| Provision for income taxes | 20.0 | (20.0) | — | — | 3.5 | (3.5) | — | — | |||||||||||||||||||||||
| GAAP Net Income (Loss)/Non-GAAP Income | $ | 81.4 | $ | 47.7 | $ | (12.6) | $ | 116.5 | $ | (56.5) | $ | 26.3 | $ | 55.0 | $ | 24.8 |
| Contact: | ||
| Investors: | Media: | |
| Traci McCarty | Debra Charlesworth | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 455-7558 | (415) 455-7451 |
SOURCE BioMarin Pharmaceutical Inc.