© 2023 BioMarin. All rights reserved.
SAN RAFAEL, Calif., Oct. 23, 2019 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) | |||||||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||
2019 | 2018 | % Change | 2019 | 2018 | % Change | ||||||||||||||||
Total Revenues | $ | 461.1 | $ | 391.7 | 18 | % | $ | 1,249.6 | $ | 1,138.0 | 10 | % | |||||||||
Net Product Revenues Marketed by BioMarin (1) | 428.1 | 358.7 | 19 | % | 1,150.6 | 1,005.5 | 14 | % | |||||||||||||
Vimizim Net Product Revenues | 163.5 | 123.3 | 33 | % | 412.0 | 368.0 | 12 | % | |||||||||||||
Kuvan Net Product Revenues | 120.6 | 113.3 | 6 | % | 340.8 | 321.4 | 6 | % | |||||||||||||
Naglazyme Net Product Revenues | 94.4 | 103.1 | (8) | % | 279.5 | 269.2 | 4 | % | |||||||||||||
Palynziq Net Product Revenues | 24.1 | 4.1 | N/M | 55.2 | 4.1 | N/M | |||||||||||||||
Brineura Net Product Revenues | 19.8 | 9.9 | 100 | % | 46.8 | 27.7 | 69 | % | |||||||||||||
Aldurazyme Net Product Revenues | 22.8 | 27.6 | (17) | % | 73.9 | 117.7 | (37) | % | |||||||||||||
GAAP Net Income (Loss) | $ | 55.0 | $ | (12.6) | $ | (38.9) | $ | (73.6) | |||||||||||||
GAAP Net Income (Loss) per Share – Basic | $ | 0.31 | $ | (0.07) | $ | (0.22) | $ | (0.42) | |||||||||||||
GAAP Net Income (Loss) per Share – Diluted | $ | 0.30 | $ | (0.07) | $ | (0.22) | $ | (0.42) | |||||||||||||
Non-GAAP Income (2) | $ | 78.1 | $ | 60.7 | $ | 120.1 | $ | 101.8 |
September 30, | December 31, | ||
Cash, cash equivalents and investments | $1,152.6 | $1,320.2 |
(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. |
(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 third quarter ended September 30, 2019.
Total Net Product Revenues for the third of quarter 2019 increased to $450.9 million, compared to $386.3 million for the third quarter of 2018. The increase in Net Product Revenues was attributed to the following:
The increase in GAAP Net Income for the third quarter of 2019, compared to GAAP Net Loss the same period in 2018 was primarily due to the following:
GAAP Net Income (Loss) Guidance for the full-year 2019 was narrowed to the low-end of the previously reported range to a loss of between $45 million to $65 million, reflecting continued expense management and strong net product sales.
Non-GAAP Income for the third quarter of 2019 increased $17.4 million, or 29%, to $78.1 million, compared to $60.7 million for the same period in 2018. The increase in Non-GAAP Income for the quarter, compared to the same period in 2018, was attributed to higher gross profit and driven by R&D expense management, partially offset by higher SG&A expense. The increase in Non-GAAP Income for the third quarter of 2019 resulted in narrowed full-year Non-GAAP income guidance to the high-end of the previously reported the range to between $150 million and $170 million.
As of September 30, 2019, BioMarin had cash, cash equivalents and investments totaling approximately $1.2 billion, as compared to $1.3 billion on December 31, 2018.
Commenting on third quarter results, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "BioMarin is entering a stage that I believe will bring significant growth as we get closer to submitting marketing applications for valoctocogene roxaparvovec for severe hemophilia A and a pivotal data read-out for vosoritide for children with achondroplasia. These potential new products, combined with our strong base business and continued financial discipline, position us for significant growth and expansion beginning in the very near future. Later this quarter, both the U.S. and European marketing applications for valoctocogene roxaparvovec for severe hemophilia A will be submitted. If the applications are approved, we could potentially be launching the first approved gene therapy product in hemophilia A in the second half of 2020. We are also encouraged by the recent recommendation by the European Medicines Agency (EMA) to grant our request for accelerated assessment of valoctocogene roxaparvovec for severe hemophilia A. We are very pleased with the level of engagement we have had with global health authorities, as it aligns with our belief that gene therapy will be the next wave of innovation for treating people with severe hemophilia A."
Mr. Bienaimé continued, "After valoctocogene roxaparvovec, vosoritide for the treatment of children with achondroplasia is our next significant commercial opportunity. Phase 3 results with vosoritide are expected by year-end. Our most recently initiated study with vosoritide, a global Phase 2 in infants and young children (less than 60 months old), is rounding the corner to complete enrollment. All subjects from ages 2 through 5 years have been enrolled. The second cohort, which includes children ages 6 months through 2 years old will complete by year-end, and the youngest cohort, infants up to 6 months old, has recently started enrolling. Interest in this study with very young children has been extremely robust, demonstrating that families are interested in treatment for their children as early as possible. Our most recently approved product, Palynziq for the treatment of phenylketonuria, is on a very strong launch trajectory since approval last year in the U.S. We have been very pleased with the pace of the U.S. launch, as we ended the third quarter with 670 patients on reimbursed Palynziq, and an additional 153 naïve patients having completed enrollment and awaiting their first injection. Building on this success, and as part of our strategy to further build our presence in the PKU market, we submitted the clinical trial application (CTA) for BMN 307, our gene therapy product for PKU, in September. BMN 307 demonstrated lifetime normalization of Phe in a validated PKU mouse model, and as a result, we believe it has the potential to be an important new treatment and market expander as part of our PKU franchise."
2019 Full-Year Financial Guidance (in millions, except %) | |||||||||||||||||||
Item | 2019 Guidance, | 2019 Updated Guidance, | |||||||||||||||||
Total Revenues | $ | 1,680 | to | $ | 1,750 | $ | 1,690 | to | $ | 1,720 | |||||||||
Vimizim Net Product Revenues | $ | 530 | to | $ | 570 | $ | 540 | to | $ | 570 | |||||||||
Kuvan Net Product Revenues | $ | 420 | to | $ | 460 | $ | 455 | to | $ | 475 | |||||||||
Naglazyme Net Product Revenues | $ | 350 | to | $ | 380 | $ | 360 | to | $ | 380 | |||||||||
Palynziq Net Product Revenues | $ | 70 | to | $ | 100 | $ | 80 | to | $ | 100 | |||||||||
Brineura Net Product Revenues | $ | 55 | to | $ | 75 | Unchanged | |||||||||||||
Cost of Sales (% of Total Revenues) | 20 | % | to | 21 | % | Unchanged | |||||||||||||
Research and Development Expense | $ | 740 | to | $ | 780 | $ | 710 | to | $ | 740 | |||||||||
Selling, General and Administrative Expense | $ | 650 | to | $ | 690 | $ | 670 | to | $ | 690 | |||||||||
GAAP Net Loss | $ | (45) | to | $ | (85) | $ | (45) | to | $ | (65) | |||||||||
Non-GAAP Income * | $ | 130 | to | $ | 170 | $ | 150 | to | $ | 170 |
* 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
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: 6989536 | Conference ID: 6989536 |
About BioMarin
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
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: the expectations of Total Revenues, Net Product Revenues and expenses for BioMarin's commercial products, Cost of Sales, GAAP Net Loss, Non-GAAP Income and other specified income statement guidance for the full-year 2019; the financial performance of BioMarin as a whole; BioMarin's potential for significant growth and expansion: BioMarin anticipating significant milestones over the coming months; BioMarin's entitlement to receive of milestone payments and royalties from Allievex that licensed rights from BioMarin for tralesinidase alfa and Allievex's assumption of financial obligations related to the development and commercialization of tralesinidase alfa; the timing of BioMarin's clinical development and commercial prospects, including (i) BioMarin's planned submissions to regulatory authorities, including marketing authorization applications for valoctocogene roxaparvovec in both the U.S. and Europe, (ii) BioMarin's clinical studies and trials, (iii) completion of enrollment of those studies and trials, including enrollment in BioMarin's Phase 3 program with valoctocogene roxaparvovec and global Phase 2 study with vosoritide, and (iv) announcements of data from those studies and trials, including BioMarin's Phase 3 program with valoctocogene roxaparvovec and the global Phase 3 study of vosoritide; the clinical development and commercialization of BioMarin's product candidates and commercial products, including (i) BioMarin's planned submission of marketing authorization applications for valoctocogene roxaparvovec, which if approved could potentially be the first approved gene therapy product for hemophilia A, (ii) product to support clinical evaluation of BMN 307 being produced using a commercial scale manufacturing process to facilitate rapid clinical development, (iii) the possible approval and commercialization of BioMarin's product candidates, including vosoritide for the treatment of achondroplasia, and (iv) the Company's securing of reimbursement for Palyzniq on a country-by-country basis in the EU and Palynziq's revenue from the EU in 2020.
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; 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 FDA, 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; the introduction of generic versions of BioMarin's commercial products, in particular generic versions of Kuvan; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 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®, Firdapse®, Kuvan®, Naglazyme®, Palynziq® and Vimizim® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
Contact: | |
Investors: | Media: |
Traci McCarty | Debra Charlesworth |
BioMarin Pharmaceutical Inc. | BioMarin Pharmaceutical Inc. |
(415) 455-7558 | (415) 455-7451 |
BIOMARIN PHARMACEUTICAL INC. | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
September 30, 2019 and December 31, 2018 | |||||||
(In thousands of U.S. dollars, except share and per share amounts) | |||||||
September 30, | December 31, | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 423,220 | $ | 493,982 | |||
Short-term investments | 297,572 | 590,326 | |||||
Accounts receivable, net | 402,970 | 342,633 | |||||
Inventory | 609,049 | 530,871 | |||||
Other current assets | 126,548 | 98,403 | |||||
Total current assets | 1,859,359 | 2,056,215 | |||||
Noncurrent assets: | |||||||
Long-term investments | 431,804 | 235,864 | |||||
Property, plant and equipment, net | 969,300 | 948,682 | |||||
Intangible assets, net | 462,849 | 491,808 | |||||
Goodwill | 197,039 | 197,039 | |||||
Deferred tax assets | 525,131 | 460,952 | |||||
Other assets | 112,646 | 36,568 | |||||
Total assets | $ | 4,558,128 | $ | 4,427,128 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable and accrued liabilities | $ | 483,745 | $ | 437,290 | |||
Short-term contingent consideration | 10,000 | 85,951 | |||||
Total current liabilities | 493,745 | 523,241 | |||||
Noncurrent liabilities: | |||||||
Long-term convertible debt, net | 843,616 | 830,417 | |||||
Long-term contingent consideration | 48,930 | 46,883 | |||||
Other long-term liabilities | 97,432 | 58,647 | |||||
Total liabilities | 1,483,723 | 1,459,188 | |||||
Stockholders' equity: | |||||||
Common stock, $0.001 par value: 500,000,000 shares authorized; 179,604,381 and 178,252,954 shares issued and outstanding, respectively. | 180 | 178 | |||||
Additional paid-in capital | 4,782,916 | 4,669,926 | |||||
Company common stock held by Nonqualified Deferred Compensation Plan | (9,961) | (13,301) | |||||
Accumulated other comprehensive income | 37,003 | 5,271 | |||||
Accumulated deficit | (1,735,733) | (1,694,134) | |||||
Total stockholders' equity | 3,074,405 | 2,967,940 | |||||
Total liabilities and stockholders' equity | $ | 4,558,128 | $ | 4,427,128 |
(1) | As of January 1, 2019, the Company adopted the requirements of Accounting Standards Codification 842, Leases, using the modified retrospective method as of the effective date, and as a result, Other Assets and Liabilities are not comparable to the prior periods presented. |
(2) | December 31, 2018 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, 2018, filed with the U.S. Securities and Exchange Commission (SEC) on February 28, 2018. |
BIOMARIN PHARMACEUTICAL INC. | |||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
Three and Nine Months Ended September 30, 2019 and 2018 | |||||||||||||||
(In thousands of U.S. dollars, except per share amounts) | |||||||||||||||
(unaudited) | |||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
REVENUES: | |||||||||||||||
Net product revenues | $ | 450,900 | $ | 386,320 | $ | 1,224,458 | $ | 1,123,205 | |||||||
Royalty and other revenues | 10,197 | 5,386 | 25,147 | 14,793 | |||||||||||
Total net revenues | 461,097 | 391,706 | 1,249,605 | 1,137,998 | |||||||||||
OPERATING EXPENSES: | |||||||||||||||
Cost of sales | $ | 96,949 | $ | 78,893 | $ | 263,567 | $ | 240,245 | |||||||
Research and development | 172,963 | 161,408 | 542,195 | 520,938 | |||||||||||
Selling, general and administrative | 170,112 | 148,566 | 493,024 | 440,182 | |||||||||||
Intangible asset amortization and contingent consideration | 17,063 | 18,580 | 57,114 | 42,009 | |||||||||||
Gain on sale of intangible assets | — | — | (15,000) | (20,000) | |||||||||||
Total operating expenses | $ | 457,087 | $ | 407,447 | $ | 1,340,900 | $ | 1,223,374 | |||||||
INCOME (LOSS) FROM OPERATIONS | $ | 4,010 | $ | (15,741) | $ | (91,295) | $ | (85,376) | |||||||
Equity in the loss of BioMarin/Genzyme LLC | (551) | (468) | (780) | (507) | |||||||||||
Interest income | 5,340 | 6,338 | 17,537 | 17,141 | |||||||||||
Interest expense | (2,937) | (12,131) | (16,530) | (35,918) | |||||||||||
Other income, net | 3,960 | 2,589 | 6,038 | 5,266 | |||||||||||
INCOME (LOSS) BEFORE INCOME TAXES | 9,822 | (19,413) | (85,030) | (99,394) | |||||||||||
Benefit from income taxes | (45,214) | (6,793) | (46,158) | (25,833) | |||||||||||
NET INCOME (LOSS) | $ | 55,036 | $ | (12,620) | $ | (38,872) | $ | (73,561) | |||||||
NET INCOME (LOSS) PER SHARE, BASIC | $ | 0.31 | $ | (0.07) | $ | (0.22) | $ | (0.42) | |||||||
NET LOSS PER SHARE, DILUTED | $ | 0.30 | $ | (0.07) | $ | (0.22) | $ | (0.42) | |||||||
Weighted average common shares outstanding, basic | 179,289 | 177,481 | 178,873 | 176,767 | |||||||||||
Weighted average common shares outstanding, diluted | 185,924 | 177,481 | 178,873 | 176,767 |
The following table presents Net Product Revenues by Product:
Net Product Revenues by Product | |||||||||||||||||||||
(In millions of U.S. dollars) | |||||||||||||||||||||
(unaudited) | |||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||
2019 | 2018 | % Change | 2019 | 2018 | % Change | ||||||||||||||||
Brineura | $ | 19.8 | $ | 9.9 | 100 | % | $ | 46.8 | $ | 27.7 | 69 | % | |||||||||
Firdapse | 5.7 | 5.0 | 14 | % | 16.3 | 15.1 | 8 | % | |||||||||||||
Naglazyme | 94.4 | 103.1 | (8) | % | 279.5 | 269.2 | 4 | % | |||||||||||||
PKU franchise | 144.7 | 117.4 | 23 | % | 396.0 | 325.5 | 22 | % | |||||||||||||
Vimizim | 163.5 | 123.3 | 33 | % | 412.0 | 368.0 | 12 | % | |||||||||||||
Net Product Revenues Marketed by BioMarin | 428.1 | 358.7 | 1,150.6 | 1,005.5 | |||||||||||||||||
Aldurazyme Net Product Revenues Marketed by Genzyme | 22.8 | 27.6 | (17) | % | 73.9 | 117.7 | (37) | % | |||||||||||||
Total Net Product Revenues | $ | 450.9 | $ | 386.3 | $ | 1,224.5 | $ | 1,123.2 |
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 | Nine Months Ended | ||||||||||||||||||||
2019 | 2018 | % Change | 2019 | 2018 | % Change | ||||||||||||||||
Kuvan | $ | 120.6 | $ | 113.3 | 6 | % | $ | 340.8 | $ | 321.4 | 6 | % | |||||||||
Palynziq | 24.1 | 4.1 | N/M | 55.2 | 4.1 | N/M | |||||||||||||||
Total PKU franchise | $ | 144.7 | $ | 117.4 | 23 | % | $ | 396.0 | $ | 325.5 | 22 | % |
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.
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 and its components 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 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 | Nine Months Ended | Guidance Year Ending | ||||||||||||||||||||||
2019 | 2018 | 2019 | 2018 | December 31, 2019 | ||||||||||||||||||||
GAAP Net Income (Loss) | $ | 55.0 | $ | (12.6) | $ | (38.9) | $ | (73.6) | $ | (45.0) | — | $ | (65.0) | |||||||||||
Interest expense, net | (2.4) | 5.8 | (1.0) | 18.8 | — | — | 10.0 | |||||||||||||||||
Benefit from income taxes | (45.2) | (6.8) | (46.2) | (25.8) | (30.0) | — | (50.0) | |||||||||||||||||
Depreciation expense | 14.4 | 18.6 | 42.3 | 48.1 | 45.0 | — | 60.0 | |||||||||||||||||
Amortization expense | 16.3 | 7.6 | 37.2 | 22.7 | 40.0 | — | 55.0 | |||||||||||||||||
Stock-based compensation expense | 39.2 | 37.1 | 121.8 | 112.3 | 150.0 | — | 175.0 | |||||||||||||||||
Contingent consideration expense | 0.8 | 11.0 | 19.9 | 19.3 | 20.0 | — | 30.0 | |||||||||||||||||
Gain on sale of intangible assets | — | — | (15.0) | (20.0) | (30.0) | — | (45.0) | |||||||||||||||||
Non-GAAP Income | $ | 78.1 | $ | 60.7 | $ | 120.1 | $ | 101.8 | $ | 150.0 | — | $ | 170.0 |
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 September 30, | |||||||||||||||||||||||||||||||
2019 | 2018 | ||||||||||||||||||||||||||||||
Adjustments | Adjustments | ||||||||||||||||||||||||||||||
GAAP | Interest, | Stock-Based | Non-GAAP | GAAP | Interest, | Stock-Based | Non-GAAP | ||||||||||||||||||||||||
Cost of sales | $ | 96.9 | $ | — | $ | (4.1) | $ | 92.8 | $ | 78.9 | $ | — | $ | (4.0) | $ | 74.9 | |||||||||||||||
Research and development | 173.0 | (6.4) | (14.3) | 152.3 | 161.4 | (7.0) | (14.3) | 140.1 | |||||||||||||||||||||||
Selling, general and administrative | 170.1 | (8.0) | (20.8) | 141.3 | 148.6 | (11.6) | (18.8) | 118.2 | |||||||||||||||||||||||
Intangible asset amortization and contingent consideration | 17.1 | (16.3) | (0.8) | — | 18.6 | (7.6) | (11.0) | — | |||||||||||||||||||||||
Gain on sale of intangible assets | — | — | — | — | — | — | — | — | |||||||||||||||||||||||
Interest expense, net | 2.4 | (2.4) | — | — | (5.8) | 5.8 | — | — | |||||||||||||||||||||||
Benefit from income taxes | (45.2) | 45.2 | — | — | (6.8) | 6.8 | — | — | |||||||||||||||||||||||
GAAP Net Income (Loss)/Non-GAAP Income | 55.0 | (16.9) | 40.0 | 78.1 | (12.6) | 25.2 | 48.1 | 60.7 | |||||||||||||||||||||||
Nine months ended September 30, | |||||||||||||||||||||||||||||||
2019 | 2018 | ||||||||||||||||||||||||||||||
Adjustments | Adjustments | ||||||||||||||||||||||||||||||
GAAP | Interest, | Stock-Based | Non-GAAP | GAAP | Interest, | Stock-Based | Non-GAAP | ||||||||||||||||||||||||
Cost of sales | $ | 263.6 | $ | — | $ | (12.6) | $ | 251.0 | $ | 240.2 | $ | — | $ | (10.4) | $ | 229.8 | |||||||||||||||
Research and development | 542.2 | (23.1) | (43.1) | 476.0 | 520.9 | (25.4) | (43.1) | 452.4 | |||||||||||||||||||||||
Selling, general and administrative | 493.0 | (19.2) | (66.1) | 407.7 | 440.2 | (22.7) | (58.8) | 358.7 | |||||||||||||||||||||||
Intangible asset amortization and contingent consideration | 57.1 | (37.2) | (19.9) | — | 42.0 | (22.7) | (19.3) | — | |||||||||||||||||||||||
Gain on sale of intangible assets | (15.0) | — | 15.0 | — | (20.0) | — | 20.0 | — | |||||||||||||||||||||||
Interest expense, net | 1.0 | (1.0) | — | — | (18.8) | 18.8 | — | — | |||||||||||||||||||||||
Benefit from income taxes | (46.2) | 46.2 | — | — | (25.8) | 25.8 | — | — | |||||||||||||||||||||||
GAAP Net Loss/Non-GAAP Income | (38.9) | 32.3 | 126.7 | 120.1 | (73.6) | 63.8 | 111.6 | 101.8 |
SOURCE BioMarin Pharmaceutical Inc.