Full Press Release Details
SAN RAFAEL, Calif. , Feb. 22, 2018 /PRNewswire/ --
| Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) | ||||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||
| 2017 | 2016 | % Change | 2017 | 2016 | % Change | |||||||||||||
| Total Revenues | $ | 358.3 | $ | 300.1 | 19% | $ | 1,313.6 | $ | 1,116.9 | 18% | ||||||||
| Aldurazyme Net Product Revenues | 28.3 | 35.0 | (19)% | 90.0 | 93.8 | (4)% | ||||||||||||
| Brineura Net Product Revenues | 5.2 | — | n/a | 8.6 | — | n/a | ||||||||||||
| Kuvan Net Product Revenues | 107.4 | 90.2 | 19% | 407.5 | 348.0 | 17% | ||||||||||||
| Naglazyme Net Product Revenues | 93.8 | 74.9 | 25% | 332.2 | 296.5 | 12% | ||||||||||||
| Vimizim Net Product Revenues | 114.0 | 93.8 | 22% | 413.3 | 354.1 | 17% | ||||||||||||
| GAAP Net Loss | $ | (51.4) | $ | (90.7) | $ | (117.0) | $ | (630.2) | ||||||||||
| GAAP Net Loss per Share - Basic | (0.29) | (0.53) | (0.67) | (3.80) | ||||||||||||||
| GAAP Net Loss per Share - Diluted | (0.30) | (0.53) | (0.67) | (3.81) | ||||||||||||||
| Non-GAAP Income (Loss) (1) | $ | 5.2 | $ | (27.5) | $ | 74.0 | $ | (36.5) | ||||||||||
| December 31, | December 31, | |||||||||||||||||
| 2017 | 2016 | |||||||||||||||||
| Cash, cash equivalents and investments | $ | 1,781.7 | $ | 1,362.4 |
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) today announced financial results for the fourth quarter and year ended December 31, 2017 . For the quarter ended December 31, 2017 GAAP Net Loss was $51.4 million , or $0.29 and $0.30 per basic and diluted share, respectively, compared to GAAP Net Loss of $90.7 million , or $0.53 per basic and diluted share, respectively, for the quarter ended December 31, 2016 . GAAP Net Loss for the year ended December 31, 2017 was $117.0 million , or $0.67 per basic and diluted share, respectively, compared to GAAP Net Loss of $630.2 million , or $3.80 and $3.81 per basic and diluted share, respectively, for the year ended December 31, 2016 . The reduction in GAAP Net Loss year over year was primarily due to increased net product revenues for Kuvan, Naglazyme and Vimizim, the $31.5 million net upfront license payment received from Sarepta Therapeutics Inc. (Sarepta) in connection with the settlement of the Company's patent proceedings against Sarepta, the $125.0 million gain on sale of intangible assets related to the sale of the Priority Review Voucher, and the absence of the impairment of intangible assets associated with the discontinuance of the Kyndrisa and reveglucosidase alfa programs in 2016, partially offset by an increase in the provision for income taxes related to the impact of the Tax Cuts and Jobs Act on the Company's operating results.
Non-GAAP Income for the three months ended December 31, 2017 was $5.2 million , compared to Non-GAAP Loss of $27.5 million for the three months ended December 31, 2016 . Non-GAAP Income for the year ended December 31, 2017 was $74.0 million , compared to Non-GAAP Loss of $36.5 million for the year ended December 31, 2016 .
Total Revenues were $1.3 billion for the year ended December 31, 2017 compared to $1.1 billion for the year ended December 31, 2016 , an increase of 18%. For the year ended December 31, 2017 , Kuvan net product revenues increased 17% year over year. Growth was driven by a 7% increase in the number of commercial patients on Kuvan therapy in North America resulting in 21% revenue growth in that region. For the year ended December 31, 2017 , Vimizim net product revenues increased by 17% year over year, due primarily to an increase of 20% in the number of Vimizim commercial patients. Naglazyme net product revenues increased 12% year over year during the year ended December 31, 2017 . The number of Naglazyme commercial patients increased 6% year over year.
As of December 31, 2017, BioMarin had cash, cash equivalents and investments totaling approximately $1.8 billion , as compared to $1.4 billion on December 31, 2016 .
Commenting on the year and the quarter, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "2017 was a momentous year for BioMarin driven by numerous financial, regulatory and clinical achievements. We reduced our GAAP Net Loss and achieved our goal of Non-GAAP profitability for the full year supported by continued strong demand for our commercial products. On the regulatory front, during the first half of 2017, we received U.S. and EU approval of our sixth commercial product, Brineura, the first treatment approved for CLN2 disease. Our late-stage clinical programs all advanced as expected, including vosoritide, pegvaliase and valoctocogene roxaparvovec (formerly referred to as BMN 270). In addition to receiving PRIME and Breakthrough Therapy designations for valoctocogene roxaparvovec gene therapy for severe hemophilia A, we shared new 1.5 year results demonstrating sustained FVIII levels within the normal range. This achievement led to the start of our global GENEr8–1 and GENEr8-2 Phase 3 studies for the treatment of patients with severe hemophilia A."
Mr. Bienaimé continued, "With pegvaliase, we were pleased to have submitted our Biologics License Application in June, which was filed for review by the FDA and received a Priority Review designation. We anticipate FDA action on our Biologics License Application for pegvaliase at the end of May 2018 , In addition, we plan to submit our Marketing Authorization Application for pegvaliase in Europe in the first quarter of 2018. Finally, we shared many significant updates at our R&D Day in the fourth quarter, including the announcement of our next IND candidate BMN 290 for Friedriech's ataxia, a rare neurologic disorder that affects nearly 15,000 people worldwide. We were also pleased to share that vosoritide for achondroplasia demonstrated a sustained increase in annualized growth rate at 30 months of treatment. We begin 2018 poised to move our 5 potential new product candidates to their next stage of clinical or regulatory development while driving top line revenues from our six commercialized products."
| Revenues (in millions of U.S. dollars, unaudited) | ||||||||||||||||||||||||
| Total Revenues | ||||||||||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||||||||
| 2017 | 2016 | $ Change | % Change | 2017 | 2016 | $ Change | % Change | |||||||||||||||||
| Aldurazyme | $ | 28.3 | $ | 35.0 | $ | (6.7) | (19)% | $ | 90.0 | $ | 93.8 | $ | (3.8) | (4)% | ||||||||||
| Brineura | 5.2 | — | 5.2 | n/a | 8.6 | — | 8.6 | n/a | ||||||||||||||||
| Firdapse | 4.8 | 4.3 | 0.5 | 12% | 18.8 | 18.0 | 0.8 | 4% | ||||||||||||||||
| Kuvan (1) | 107.4 | 90.2 | 17.2 | 19% | 407.5 | 348.0 | 59.5 | 17% | ||||||||||||||||
| Naglazyme (2) | 93.8 | 74.9 | 18.9 | 25% | 332.2 | 296.5 | 35.7 | 12% | ||||||||||||||||
| Vimizim (2) | 114.0 | 93.8 | 20.2 | 22% | 413.3 | 354.1 | 59.2 | 17% | ||||||||||||||||
| Net Product Revenues | 353.5 | 298.2 | 55.3 | 19% | 1,270.4 | 1,110.4 | 160.0 | 14% | ||||||||||||||||
| Royalty and other revenues | 4.8 | 1.9 | 2.9 | 43.2 | 6.5 | 36.7 | ||||||||||||||||||
| Total revenues | $ | 358.3 | $ | 300.1 | $ | 58.2 | 19% | $ | 1,313.6 | $ | 1,116.9 | $ | 196.7 | 18% |
| (1) | Kuvan revenue growth was driven by a 7% increase in the number of commercial patients on Kuvan therapy in the U.S. |
| (2) | Naglazyme and Vimizim net product revenues experience quarterly fluctuations primarily due to the timing of government ordering patterns in certain countries. |
| Details of Net Product Revenues Attributable to Aldurazyme | ||||||||||||||||||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||||||||||||||||
| 2017 | 2016 | $ Change | % Change | 2017 | 2016 | $ Change | % Change | |||||||||||||||||||||||||
| Aldurazyme revenue reported by Genzyme | $ | 57.5 | $ | 54.8 | $ | 2.7 | 5 | % | $ | 233.8 | $ | 223.3 | $ | 10.5 | 5 | % |
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||||||||||||
| 2017 | 2016 | $ Change | 2017 | 2016 | $ Change | |||||||||||||||||||||
| Revenues earned based on Genzyme net sales | $ | 27.9 | $ | 26.9 | $ | 1.0 | $ | 102.1 | $ | 98.1 | $ | 4.0 | ||||||||||||||
| Net product transfer revenues (3) | 0.4 | 8.1 | (7.7) | (12.1) | (4.3) | (7.8) | ||||||||||||||||||||
| Total Aldurazyme net product revenues | $ | 28.3 | $ | 35.0 | $ | (6.7) | $ | 90.0 | $ | 93.8 | $ | (3.8) |
| 2018 Financial Guidance | ||
| Full-year Revenue Guidance ($ in millions) | ||
| Item | ||
| 2018 Guidance | ||
| Total Revenues | $1,470 to $1,530 | |
| Kuvan Net Product Revenues | $440 to $480 | |
| Naglazyme Net Product Revenues | $325 to $355 | |
| Vimizim Net Product Revenues | $460 to $500 | |
| Brineura Net Product Revenues | $35 to $55 |
| Select Full-year Income Statement Guidance ($ in millions, except percentages) | ||
| Item | ||
| 2018 Guidance | ||
| Cost of Sales (% of Total Revenues) | 20.0% to 21.0% | |
| Research and Development Expense | $645 to $685 | |
| Selling, General and Admin. Expense | $575 to $615 | |
| GAAP Net Loss | $(115) to $(165) | |
| Non-GAAP Income | $100 to $140 |
* All Financial Guidance items are calculated based on Generally Accepted Accounting Principles (GAAP) with the exception of Non-GAAP Income. 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 GAAP reported information.
Key Program Highlights
Conference Call Details
BioMarin will host a conference call and webcast to discuss third quarter 2017 financial results today, Thursday, February 22, 2018 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: 5289587 | Conference ID: 5289587 |
About BioMarin BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The Company's portfolio consists of six approved products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.biomarin.com .
BioMarin ® , Brineura ® , Firdapse ® , Kuvan ® , Naglazyme ® and Vimizim ® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Kyndrisa TM is a trademark of BioMarin Pharmaceutical Inc. Aldurazyme ® is a registered trademark of BioMarin/Genzyme LLC.
| BIOMARIN PHARMACEUTICAL INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| December 31, 2017 and December 31, 2016 | ||||||||
| (In thousands of U.S. dollars, except share and per share amounts) | ||||||||
| December 31, 2017 | December 31, 2016(1) | |||||||
| ASSETS | (unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 598,028 | $ | 408,330 | ||||
| Short-term investments | 797,940 | 381,347 | ||||||
| Accounts receivable, net | 261,365 | 215,280 | ||||||
| Inventory | 475,775 | 355,126 | ||||||
| Other current assets | 74,036 | 61,708 | ||||||
| Total current assets | 2,207,144 | 1,421,791 | ||||||
| Noncurrent assets: | ||||||||
| Long-term investments | 385,785 | 572,711 | ||||||
| Property, plant and equipment, net | 896,700 | 798,768 | ||||||
| Intangible assets, net | 517,510 | 553,780 | ||||||
| Goodwill | 197,039 | 197,039 | ||||||
| Deferred tax assets | 399,095 | 446,786 | ||||||
| Other assets | 29,852 | 32,815 | ||||||
| Total assets | $ | 4,633,125 | $ | 4,023,690 | ||||
| LIABILITIES AND STOCKHOLDERS ' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued liabilities | $ | 401,921 | $ | 370,505 | ||||
| Short-term convertible debt, net | 360,949 | 22,478 | ||||||
| Short-term contingent acquisition consideration payable | 53,648 | 46,327 | ||||||
| Total current liabilities | 816,518 | 439,310 | ||||||
| Noncurrent liabilities: | ||||||||
| Long-term convertible debt, net | 813,521 | 660,761 | ||||||
| Long-term contingent acquisition consideration payable | 135,318 | 115,310 | ||||||
| Other long-term liabilities | 59,105 | 42,034 | ||||||
| Total liabilities | 1,824,462 | 1,257,415 | ||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.001 par value: 500,000,000 and 250,000,000 shares authorized, respectively; 175,843,749 and 172,647,588 shares issued and outstanding, respectively. | 176 | 173 | ||||||
| Additional paid-in capital | 4,483,220 | 4,288,113 | ||||||
| Company common stock held by Nonqualified Deferred Compensation Plan (the NQDC) | (14,224) | (14,321) | ||||||
| Accumulated other comprehensive income (loss) | (22,961) | 12,816 | ||||||
| Accumulated deficit | (1,637,548) | (1,520,506) | ||||||
| Total stockholders' equity | 2,808,663 | 2,766,275 | ||||||
| Total liabilities and stockholders' equity | $ | 4,633,125 | $ | 4,023,690 |
| BIOMARIN PHARMACEUTICAL INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| Three and Twelve Months Ended December 31, 2017 and 2016 | ||||||||||||||||
| (In thousands of U.S. dollars, except per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| REVENUES: | ||||||||||||||||
| Net product revenues | $ | 353,577 | $ | 298,186 | $ | 1,270,445 | $ | 1,110,381 | ||||||||
| Royalty and other revenues | 4,728 | 1,905 | 43,201 | 6,473 | ||||||||||||
| Total revenues | 358,305 | 300,091 | 1,313,646 | 1,116,854 | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Cost of sales | 75,995 | 64,147 | 241,786 | 209,620 | ||||||||||||
| Research and development | 168,608 | 175,242 | 610,753 | 661,905 | ||||||||||||
| Selling, general and administrative | 160,280 | 142,958 | 554,336 | 476,593 | ||||||||||||
| Intangible asset amortization and contingent consideration | 20,375 | 7,365 | 46,471 | (26,953) | ||||||||||||
| Impairment of intangible assets | — | — | — | 599,118 | ||||||||||||
| Gain on sale of intangible asset | (125,000) | — | (125,000) | — | ||||||||||||
| Total operating expenses | 300,258 | 389,712 | 1,328,346 | 1,920,283 | ||||||||||||
| INCOME (LOSS) FROM OPERATIONS | 58,047 | (89,621) | (14,700) | (803,429) | ||||||||||||
| Equity in the loss of BioMarin/Genzyme LLC | (295) | (164) | (1,291) | (538) | ||||||||||||
| Interest income | 4,822 | 2,926 | 14,853 | 7,487 | ||||||||||||
| Interest expense | (11,664) | (9,732) | (42,707) | (39,499) | ||||||||||||
| Other income (expense) | 3,688 | 4,425 | 7,970 | 4,929 | ||||||||||||
| INCOME (LOSS) BEFORE INCOME TAXES | 54,598 | (92,166) | (35,875) | (831,050) | ||||||||||||
| Provision for (benefit from) income taxes | 105,990 | (1,446) | 81,167 | (200,840) | ||||||||||||
| NET LOSS | $ | (51,392) | $ | (90,720) | $ | (117,042) | $ | (630,210) | ||||||||
| NET LOSS PER SHARE, BASIC | $ | (0.29) | $ | (0.53) | $ | (0.67) | $ | (3.80) | ||||||||
| NET LOSS PER SHARE, DILUTED | $ | (0.30) | $ | (0.53) | $ | (0.67) | $ | (3.81) | ||||||||
| Weighted average common shares outstanding, basic | 175,485 | 172,006 | 174,427 | 165,985 | ||||||||||||
| Weighted average common shares outstanding, diluted | 175,705 | 172,240 | 174,427 | 166,219 |
Non-GAAP Information
The results presented in this press release for the three and twelve months ended December 31, 2017 and 2016 include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income (Loss) is defined by the Company as GAAP Net Loss excluding net interest expense, provision for (benefit from) income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and certain other specified items, as detailed below. In addition, BioMarin includes in this press release the effects of these adjustments on certain components of GAAP Net Loss for each of the periods presented. In this regard, Non-GAAP income (loss) and its components, including Non-GAAP Royalty and Other Revenues, 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 Sale of Intangible Assets, and Non-GAAP Provision for (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 (Loss) 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 Loss to Non-GAAP Income (Loss):
| Reconciliation of GAAP Net Loss to Non-GAAP Income (Loss) | |||||||||||||||||
| (In millions of U.S. dollars) | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| Three Months Ended | Twelve Months Ended | Year Ending | |||||||||||||||
| December 31, | December 31, | December 31, 2018 | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | Guidance | |||||||||||||
| GAAP Net Loss | $ | (51.4) | $ | (90.7) | $ | (117.0) | $ | (630.2) | $(115.0) - $(165.0) | ||||||||
| Interest expense, net | 6.8 | 6.8 | 27.9 | 32.0 | 25.0 - 35.0 | ||||||||||||
| Provision for (benefit from) income taxes | 106.0 | (1.4) | 81.2 | (200.8) | (40.0) - 0.0 | ||||||||||||
| Depreciation expense | 14.8 | 13.1 | 51.7 | 55.8 | 50.0 - 60.0 | ||||||||||||
| Amortization expense | 13.4 | 7.6 | 36.2 | 30.2 | 30.0 | ||||||||||||
| Stock-based compensation expense | 33.6 | 37.3 | 140.2 | 134.6 | 150.0 - 170.0 | ||||||||||||
| Contingent consideration expense (1) | 7.0 | (0.2) | 10.3 | (57.2) | 20.0 - 30.0 | ||||||||||||
| Impairment charges (2) | — | — | — | 599.1 | - | ||||||||||||
| Gain on sale of intangible asset (3) | (125.0) | — | (125.0) | — | (20.0) | ||||||||||||
| Royalty and other revenues (4) | — | — | (31.5) | — | - | ||||||||||||
| Non-GAAP Income (Loss) | $ | 5.2 | $ | (27.5) | $ | 74.0 | $ | (36.5) | $100 - $140 |
The following reconciliation of the GAAP reported to 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 December 31, | |||||||||||||||||||||||||||||||
| 2017 | 2016 | ||||||||||||||||||||||||||||||
| Adjustments | Adjustments | ||||||||||||||||||||||||||||||
| GAAP Reported | Interest, Taxes, Depreciation and Amortization | Royalty and Other Revenues, Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non- GAAP | GAAP Reported | Interest, Taxes, Depreciation and Amortization | Royalty and Other Revenues, Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non- GAAP | ||||||||||||||||||||||||
| Cost of sales | $ | 76.0 | $ | — | $ | (2.8) | $ | 73.2 | $ | 64.1 | $ | — | $ | (3.1) | $ | 61.0 | |||||||||||||||
| Research and development | 168.6 | (8.0) | (13.2) | 147.4 | 175.2 | (7.6) | (15.3) | 152.3 | |||||||||||||||||||||||
| Selling, general and administrative | 160.3 | (6.8) | (17.6) | 135.9 | 143.0 | (5.5) | (18.9) | 118.6 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration (1) | 20.4 | (13.4) | (7.0) | — | 7.4 | (7.6) | 0.2 | — | |||||||||||||||||||||||
| Gain on sale of intangible asset (3) | (125.0) | — | 125.0 | — | — | — | — | ||||||||||||||||||||||||
| Interest expense, net | (6.8) | 6.8 | — | — | (6.8) | 6.8 | — | — | |||||||||||||||||||||||
| Provision for (benefit from) income taxes | 106.0 | (106.0) | — | — | (1.4) | 1.4 | — | — | |||||||||||||||||||||||
| GAAP Net Loss/Non-GAAP Income (Loss) | (51.4) | 141.0 | (84.4) | 5.2 | (90.7) | 26.1 | 37.1 | (27.5) |
| Twelve Months Ended December 31, | |||||||||||||||||||||||||||||||
| 2017 | 2016 | ||||||||||||||||||||||||||||||
| Adjustments | Adjustments | ||||||||||||||||||||||||||||||
| GAAP Reported | Interest, Taxes, Depreciation and Amortization | Royalty and Other Revenues, Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non- GAAP | GAAP Reported | Interest, Taxes, Depreciation and Amortization | Royalty and Other Revenues, Stock-Based Compensation, Contingent Consideration and Other Adjustments | Non- GAAP | ||||||||||||||||||||||||
| Royalty and other revenues (4) | $ | 43.2 | $ | — | $ | (31.5) | $ | 11.7 | $ | 6.5 | $ | — | $ | — | $ | 6.5 | |||||||||||||||
| Cost of sales | 241.8 | — | (10.6) | 231.2 | 209.6 | — | (9.1) | 200.5 | |||||||||||||||||||||||
| Research and development | 610.8 | (28.2) | (53.1) | 529.5 | 661.9 | (31.0) | (58.3) | 572.6 | |||||||||||||||||||||||
| Selling, general and administrative | 554.3 | (23.5) | (76.5) | 454.3 | 476.6 | (24.8) | (67.2) | 384.6 | |||||||||||||||||||||||
| Intangible asset amortization and contingent consideration (1) | 46.5 | (36.2) | (10.3) | — | (27.0) | (30.2) | 57.2 | — | |||||||||||||||||||||||
| Impairment of intangible assets (2) | — | — | — | — | 599.1 | — | (599.1) | — | |||||||||||||||||||||||
| Gain on sale of intangible asset (3) | (125.0) | — | 125.0 | — | — | — | — | — | |||||||||||||||||||||||
| Interest expense, net | (27.9) | 27.9 | — | — | (32.0) | 32.0 | — | — | |||||||||||||||||||||||
| Provision for (benefit from) income taxes | 81.2 | (81.2) | — | — | (200.8) | 200.8 | — | — | |||||||||||||||||||||||
| GAAP Net Loss/Non-GAAP Income (Loss) | (117.0) | 197.0 | (6.0) | 74.0 | (630.2) | (82.8) | 676.5 | (36.5) |
| 1. | Amounts include the expense associated with the change in the fair value of contingent acquisition consideration payable for the period, resulting from changes in estimated probabilities and timing of achieving certain regulatory and commercial milestones. Amounts for the year ended December 31, 2016 include $43.8 million and $21.1 million related to the change in probability of achieving the Kyndrisa and reveglucosidase alfa development milestones, respectively, as a result of discontinuance of these programs in June 2016. |
| 2. | Amounts for the twelve months ended December 31, 2016 include $574.1 million and $25.0 million for the impairment of intangible assets associated with the discontinuance of the Kyndrisa and Reveglucosidase alpha development programs, respectively. |
| 3. | Amount represents gain on the sale of the Priority Review Voucher in December 2017. |
| 4. | Primarily represents the one-time upfront payment related to the License and Settlement Agreement entered into with Sarepta Therapeutics, Inc. in July 2017. |
| Contact: | ||
| Investors: | Media: | |
| Traci McCarty | Debra Charlesworth | |
| BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. | |
| (415) 455-7558 | (415) 455-7451 |
SOURCE BioMarin Pharmaceutical Inc.