Recent Updates
Recently added Catalysts
BMRN

BioMarin Announces Third Quarter 2020 Total Revenues of $477 Million Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended September 30, Nine Months Ended September 30, ...

Key Takeaway: SAN RAFAEL, Calif. , Nov. 5, 2020 /PRNewswire/ -- Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) (BioMarin or the Company) today announced financial results for the third quarter ended September

Full Press Release Details

SAN RAFAEL, Calif. , Nov. 5, 2020 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2020 2019 % Change 2020 2019 % Change
Total Revenues $ 476.8 $ 461.1 3 % $ 1,408.3 $ 1,249.6 13 %
Net Product Revenues Marketed by BioMarin (1) 419.8 428.1 (2) % 1,239.9 1,150.6 8 %
Vimizim Net Product Revenues 147.9 163.5 (10) % 401.8 412.0 (2) %
Kuvan Net Product Revenues 124.1 120.6 3 % 368.7 340.8 8 %
Naglazyme Net Product Revenues 76.3 94.4 (19) % 271.6 279.5 (3) %
Palynziq Net Product Revenues 46.1 24.1 91 % 121.4 55.2 120 %
Brineura Net Product Revenues 25.4 19.8 28 % 75.2 46.8 61 %
Aldurazyme Net Product Revenues 40.9 22.8 79 % 128.9 73.9 74 %
GAAP Net Income (Loss) $ 784.8 $ 55.0 $ 837.0 $ (38.9)
GAAP Net Income (Loss) per Share – Basic $ 4.33 $ 0.31 $ 4.63 $ (0.22)
GAAP Net Income (Loss) per Share – Diluted $ 4.01 $ 0.30 $ 4.39 $ (0.22)
Non-GAAP Income (2) $ 98.7 $ 78.1 $ 272.6 $ 120.1
September 30, 2020 December 31, 2019
Cash, cash equivalents and investments $ 1,770.8 $ 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 8 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 is reflected in the Company's consolidated financial statements for the three and nine months ending September 30, 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 9 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, 2020.
Net Product Revenues for the third quarter of 2020 increased to $460.7 million , compared to $450.9 million in the third quarter of 2019. The increase in Net Product Revenues was primarily attributed to the following:
The increase in GAAP Net Income for the third quarter of 2020, compared to the same period in 2019 was primarily due to the following:
Non-GAAP Income for the third quarter of 2020 increased to $98.7 million , compared to Non-GAAP Income of $78.1 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 decreased R&D expense and higher gross profit, excluding the $81.2 million pre-launch inventory charge, partially offset by higher SG&A expense.
As of September 30, 2020, BioMarin had cash, cash equivalents and investments totaling approximately $1.8 billion , which includes net proceeds of $535.8 million from the Company's May 2020 convertible debt offering, as compared to $1.2 billion on December 31, 2019. On October 15, 2020 , the Company's 1.50% senior subordinate convertible notes matured and were settled in cash for approximately $375.0 million .
Commenting on third quarter 2020 results, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "While the impact of COVID-19 continued through the third quarter, BioMarin employees remained focused on our mission to serve patients and ensure the steady supply of our critically-important medicines. In these continued unpredictable times, the essential nature of our products to the people who rely on them remains constant."
Mr. Bienaimé continued, "In the third quarter we received unexpected news on the status of our application with valoctocogene roxaparvovec for hemophilia A from health authorities, which resulted in a delay in potential approval timelines. However, we remain confident in our valoctocogene roxaparvovec gene therapy and its potential to redefine the treatment paradigm for people with hemophilia A. We continue to work with the health authorities to align on next steps toward approval. Our 134-subject Phase 3 study with valoctocogene roxaparvovec will complete one-year of observation in all subjects later this month, and we anticipate sharing top-line results comprising 1 to 2 years of follow-up from that study, in the first quarter of 2021. We also plan to submit the complete one-year Phase 3 data to the EMA in the second quarter of 2021."
"Vosoritide for the treatment of achondroplasia is advancing as planned with applications under review in both the U.S. and Europe with potential regulatory approvals anticipated in 2021. The significant unmet medical need for children with achondroplasia has enabled BioMarin to build a multi-pronged dossier of clinical studies. It includes the highly statistically significant placebo-controlled Phase 3 results, long-term clinical results in 5 to 18 year-olds from our Phase 2 study, natural history data, and the ongoing study of newborns through 5 years, which is nearing enrollment completion. The positive results from our vosoritide clinical programs bolster our confidence in the potential for this drug to be the first pharmacological treatment to address the underlying cause of achondroplasia. Interest in our clinical studies with vosoritide has been extremely robust, demonstrating that many families are keen to seek early treatment for their children."
Mr. Bienaimé concluded, "Despite the impact from COVID-19 and the timing set-back on the potential approval of valoctocogene roxaparvovec, we remain confident in our business. BioMarin fundamentals are strong, driven by our global base business of essential medicines and cash position, but our people and pursuit and development of innovative therapies will always be our most important assets."
2020 Full-Year Financial Guidance (in millions, except %)
Item Provided August 4, 2020 Revised November 5, 2020
Total Revenues (1) $1,850 to $1,950 $1,810 to $1,870
Vimizim Net Product Revenues $530 to $570 $515 to $545
Kuvan Net Product Revenues $430 to $480 Unchanged
Naglazyme Net Product Revenues $360 to $400 $370 to $400
Palynziq Net Product Revenues $160 to $190 Unchanged
Brineura Net Product Revenues $85 to $115 $90 to $110
Cost of Sales (% of Total Revenues) (2) 20% to 21% 26% to 28%
Research and Development Expense $675 to $725 $630 to $670
Selling, General and Administrative Expense $780 to $830 $725 to $765
GAAP Net Income $720 to $980 $760 to $820
Non-GAAP Income (3) $260 to $310 $280 to $330
(1) 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. Total Revenue guidance also reflects the impact of the valoctocogene roxaparvovec FDA Complete Response Letter whereby the Company no longer expects any revenue from valoctocogene roxaparvovec in 2020 and the previously anticipated October 2020 loss of market exclusivity for Kuvan in the U.S. Management also notes that the impact of COVID-19 on revenues is expected to persist into 2021 due primarily to the effect of delays in new patients initiating therapy.
(2) Revised Cost of Sales guidance for 2020 reflects the incremental charge of $81.2 million during the third quarter of 2020 related to valoctocogene roxaparvovec pre-launch inventory reserves.
(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 9 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 third quarter 2020 financial results today, Thursday, November 5, 2020 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: 3291898 Conference ID: 3291898
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.
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, 2020 and December 31, 2019
(In thousands of U.S. dollars, except per share amounts)
September 30, 2020 December 31, 2019(1)
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 1,015,675 $ 437,446
Short-term investments 489,998 316,361
Accounts receivable, net 411,712 377,404
Inventory 700,847 680,275
Other current assets 120,747 130,657
Total current assets 2,738,979 1,942,143
Noncurrent assets:
Long-term investments 265,122 411,978
Property, plant and equipment, net 1,015,062 1,010,868
Intangible assets, net 427,172 456,580
Goodwill 196,199 197,039
Deferred tax assets 1,396,547 549,422
Other assets 119,009 122,009
Total assets $ 6,158,090 $ 4,690,039
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 480,403 $ 570,621
Short-term convertible debt, net 374,290 361,882
Total current liabilities 854,693 932,503
Noncurrent liabilities:
Long-term convertible debt, net 1,074,164 486,238
Long-term contingent consideration 54,103 50,793
Other long-term liabilities 121,237 98,124
Total liabilities $ 2,104,197 $ 1,567,658
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 shares authorized; 181,492,344 and 179,838,114 shares issued and outstanding, respectively. 181 180
Additional paid-in capital 4,937,791 4,832,707
Company common stock held by Nonqualified Deferred Compensation Plan (10,756) (9,961)
Accumulated other comprehensive income 10,385 20,164
Accumulated deficit (883,708) (1,720,709)
Total stockholders' equity 4,053,893 3,122,381
Total liabilities and stockholders' equity $ 6,158,090 $ 4,690,039
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Nine Months Ended September 30, 2020 and 2019
(In thousands of U.S. dollars, except per share amounts)
Three Months Ended September 30, Nine Months Ended September 30,
2020 2019 2020 2019
(unaudited) (unaudited) (unaudited) (unaudited)
REVENUES:
Net product revenues $ 460,741 $ 450,900 $ 1,368,816 $ 1,224,458
Royalty and other revenues 16,043 10,197 39,522 25,147
Total net revenues 476,784 461,097 1,408,338 1,249,605
OPERATING EXPENSES:
Cost of sales 188,793 96,949 398,134 263,567
Research and development 147,053 172,963 471,449 542,195
Selling, general and administrative 179,450 170,112 542,157 493,024
Intangible asset amortization and contingent consideration 17,429 17,063 48,018 57,114
Gain on sale of nonfinancial assets (59,495) (15,000)
Total operating expenses 532,725 457,087 1,400,263 1,340,900
INCOME (LOSS) FROM OPERATIONS (55,941) 4,010 8,075 (91,295)
Equity in the loss of BioMarin/Genzyme LLC (921) (551) (1,077) (780)
Interest income 4,004 5,340 13,539 17,537
Interest expense (9,597) (2,937) (24,560) (16,530)
Other income, net 1,239 3,960 1,886 6,038
INCOME (LOSS) BEFORE INCOME TAXES (61,216) 9,822 (2,137) (85,030)
Benefit from income taxes (846,019) (45,214) (839,138) (46,158)
NET INCOME (LOSS) 784,803 55,036 837,001 (38,872)
NET INCOME (LOSS) PER SHARE, BASIC $ 4.33 $ 0.31 $ 4.63 $ (0.22)
NET INCOME (LOSS) PER SHARE, DILUTED $ 4.01 $ 0.30 $ 4.39 $ (0.22)
Weighted average common shares outstanding, basic 181,142 179,289 180,592 178,873
Weighted average common shares outstanding, diluted 197,674 185,924 194,959 178,873
The following table presents Net Product Revenues by Product:
Net Product Revenues by Product
(In millions of U.S. dollars)
Three Months Ended September 30, Nine Months Ended September 30,
2020 2019 % Change 2020 2019 % Change
(unaudited) (unaudited) (unaudited) (unaudited)
PKU franchise $ 170.2 $ 144.7 18 % $ 490.1 $ 396.0 24 %
Vimizim 147.9 163.5 (10) % 401.8 412.0 (2) %
Naglazyme 76.3 94.4 (19) % 271.6 279.5 (3) %
Brineura 25.4 19.8 28 % 75.2 46.8 61 %
Firdapse (1) 5.7 (100) % 1.2 16.3 (93) %
Net Product Revenues Marketed by BioMarin 419.8 428.1 1,239.9 1,150.6
Aldurazyme Net Product Revenues Marketed by Genzyme 40.9 22.8 79 % 128.9 73.9 74 %
Total Net Product Revenues $ 460.7 $ 450.9 $ 1,368.8 $ 1,224.5
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 September 30, Nine Months Ended September 30,
2020 2019 % Change 2020 2019 % Change
(unaudited) (unaudited) (unaudited) (unaudited)
Kuvan $ 124.1 120.6 3 % $ 368.7 340.8 8 %
Palynziq 46.1 24.1 91 % 121.4 55.2 120 %
Total PKU franchise $ 170.2 $ 144.7 18 % $ 490.1 $ 396.0 24 %
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 September 30, Nine Months Ended September 30, Guidance Year Ending
2020 2019 2020 2019 December 31, 2020
GAAP Net Income (Loss) $ 784.8 $ 55.0 $ 837.0 $ (38.9) $ 760.0 $ 820.0
Interest expense, net 5.6 (2.4) 11.0 (1.0) 13.0 11.0
Benefit from income taxes (846.0) (45.2) (839.1) (46.2) (845.8) (838.8)
Depreciation expense 11.1 14.4 31.1 42.3 50.0 47.0
Amortization expense 15.5 16.3 46.7 37.2 63.0 61.0
Stock-based compensation expense 50.2 39.2 142.2 121.8 195.4 185.4
Contingent consideration expense 1.9 0.8 1.3 19.9 2.0 2.0
Provision for inventory reserve, net (1) 75.6 75.6 75.6 75.6
Gain on sale of nonfinancial assets (59.5) (15.0) (59.5) (59.5)
Licensed In-Process R&D (2) 26.3 26.3 26.3
Non-GAAP Income $ 98.7 $ 78.1 $ 272.6 $ 120.1 $ 280.0 $ 330.0
(1) Represents a $81.2 million charge related to pre-launch valoctocogene roxaparvovec inventory, net of stock-based compensation, as a result of the unexpected delays in anticipated regulatory approvals.
(2) Represents the upfront license fee paid to a third party and recognized as R&D expense in the second quarter of 2020.
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,
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 $ 188.8 $ $ (86.0) $ 102.8 $ 96.9 $ $ (4.1) $ 92.8
Research and development 147.1 (5.8) (15.7) 125.6 173.0 (6.4) (14.3) 152.3
Selling, general and administrative 179.5 (5.3) (24.1) 150.1 170.1 (8.0) (20.8) 141.3
Intangible asset amortization and contingent consideration 17.4 (15.5) (1.9) 17.1 (16.3) (0.8)
Gain on sale of nonfinancial assets
Interest expense, net (5.6) 5.6 2.4 (2.4)
Benefit from income taxes (846.0) 846.0 (45.2) 45.2
GAAP Net Income /Non-GAAP Income $ 784.8 $ (813.8) $ 127.7 $ 98.7 $ 55.0 $ (16.9) $ 40.0 $ 78.1
Nine months ended September 30,
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 $ 398.1 $ 0.0 $ (96.0) $ 302.1 $ 263.6 $ 0.0 (12.6) $ 251.0
Research and development 471.4 (15.2) (71.7) 384.5 542.2 (23.1) (43.1) 476.0
Selling, general and administrative 542.2 (15.9) (76.4) 449.9 493.0 (19.2) (66.1) 407.7
Intangible asset amortization and contingent consideration 48.0 (46.7) (1.3) 57.1 (37.2) (19.9)
Gain on sale of nonfinancial assets (59.5) 59.5 (15.0) 15.0
Interest expense, net (11.0) 11.0 1.0 (1.0)
Benefit from income taxes (839.1) 839.1 (46.2) 46.2
GAAP Net Income (Loss)/Non-GAAP Income 837.0 (750.3) 185.9 272.6 (38.9) 32.3 126.7 120.1
SOURCE BioMarin Pharmaceutical Inc.

Related Links

21 %

Last updated: Nov 5, 2020