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BioMarin Announces Third Quarter 2017 Financial Results Financial Highlights (in millions of U.S. dollars, except per share data, unaudited) Three Months Ended September 30, Nine Months Ended September 30, ...

Thursday, October 26, 2017 7 min read
Key Takeaway: SAN RAFAEL, Calif. , Oct. 26, 2017 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) today announced financial results for the third quarter ended September 30, 2017 . For the quarter ended September 30, 2017 , GAAP Net Loss was $(12.5) million , or $(0.07) per basic

Full Press Release Details

SAN RAFAEL, Calif. , Oct. 26, 2017 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 % Change 2017 2016 % Change
Total Revenues $ 334.1 $ 279.9 19 % $ 955.3 $ 816.8 17 %
Aldurazyme Net Product Revenues 22.4 23.7 (5) % 61.7 58.8 5 %
Brineura Net Product Revenues 3.1 — n/a 3.4 — n/a
Kuvan Net Product Revenues 105.8 90.9 16 % 300.1 257.8 16 %
Naglazyme Net Product Revenues 72.1 77.8 (7) % 238.4 221.6 8 %
Vimizim Net Product Revenues 90.3 80.9 12 % 299.3 260.3 15 %
GAAP Net Loss $ (12.5) $ (37.4) $ (65.7) $ (539.5)
GAAP Net Loss per Share - Basic $ (0.07) $ (0.22) $ (0.38) $ (3.29)
GAAP Net Loss per Share - Diluted $ (0.07) $ (0.22) $ (0.38) $ (3.30)
Non-GAAP Income (Loss) (1) $ 7.8 $ 2.9 $ 68.7 $ (8.9)
September 30, December 31,
2017 2016
Cash, cash equivalents and investments $ 1,673.4 $ 1,362.4
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN ) today announced financial results for the third quarter ended September 30, 2017 . For the quarter ended September 30, 2017 , GAAP Net Loss was $(12.5) million , or $(0.07) per basic and diluted share, compared to GAAP Net Loss of $(37.4) million , or $(0.22) per basic and diluted share for the quarter ended September 30, 2016 . The reduction in GAAP Net Loss year over year was primarily due to the $31.5 million net upfront license payment received as a result of the License and Settlement Agreements entered into with Sarepta Therapeutics Inc. in July 2017 . The decreased GAAP Net Loss was also driven by increased net product revenues for Kuvan and Vimizim, partially offset by a decrease in the Benefit From Income Taxes, and increased Selling, General and Administrative expenses for Kuvan, Brineura and Vimizim. BioMarin also announced today that full year GAAP net loss guidance is being reduced to between ($110) million and ($130) million .
Non-GAAP Income for the third quarter ended September 30, 2017 was $7.8 million , compared to Non-GAAP Income of $2.9 million for the quarter ended September 30, 2016 . BioMarin also announced today that full year Non-GAAP Income guidance is being increased to between $60 million and $80 million .
Total Revenues were $334.1 million for the third quarter of 2017, and were $955.3 million for the nine months ended September 30, 2017 , an increase of 19% and 17% respectively compared to the same periods in 2016. For the nine months ended September 30, 2017 , Kuvan net product revenues increased 16% year over year. Growth was driven by a 9% increase in the number of commercial patients on Kuvan therapy in the U.S and the continued growth in the ex-North American territories acquired in 2016. For the nine months ended September 30, 2017 , Naglazyme net product revenues increased by 8% year over year, due primarily to an increase of 7% in the number of Naglazyme commercial patients. Vimizim net product revenues increased 15% year over year during the nine months ended September 30, 2017 . The number of Vimizim commercial patients increased 23% year over year.
On October 18, 2017 , the Company commented on its Total Revenue and Non-GAAP Income (Loss) trends for the third quarter and full-year 2017. In terms of the overall commercial business, BioMarin stated that sales of products in markets throughout most of the world are performing at or above internal expectations. However, the Company said the one exception is Brazil , where a slowdown in federal purchasing orders had extended into the third quarter of this year. As a result, third quarter revenues were negatively impacted. Since October 18 , the Brazilian Ministry of Health has initiated their purchasing process which is expected to result in net product revenue from Brazil in the fourth quarter. Based on this order Total Revenues for full-year 2017 are confirmed to be within prior guidance.
As of September 30, 2017, BioMarin had cash, cash equivalents and investments totaling approximately $1.7 billion , as compared to $1.4 billion on December 31, 2016 .
Commenting on the quarter, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "We achieved a number of important strategic milestones so far this year, including record Total Revenues in the third quarter and the go ahead from both U.S. and U.K. health authorities to begin Phase 3 studies with valoctocogene roxaparvovec (formerly referred to as BMN 270) gene therapy program for severe hemophilia A by year-end." Mr. Bienaimé continued, "We had many significant updates at our recent R&D Day, including the announcement of our next IND candidate BMN 290 for Freidriech'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. For pegvaliase, we anticipate FDA action on our Biologics License Application in the first half of 2018, as well as our planned submission of the Marketing Authorization Application in Europe in the first quarter of 2018. With these programs all advancing, supported by our strong base commercial business, we have reduced our GAAP Net Loss guidance and increased our Non-GAAP Income guidance for the full-year 2017."
Revenues (in millions of U.S. dollars, unaudited)
Total Revenues
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 $ Change % Change 2017 2016 $ Change % Change
Aldurazyme $ 22.4 $ 23.7 $ (1.3) (5) % $ 61.7 $ 58.8 $ 2.9 5 %
Brineura 3.1 — 3.1 n/a 3.4 — 3.4 n/a
Firdapse 5.1 5.0 0.1 2 % 14.0 13.7 0.3 2 %
Kuvan (1) 105.8 90.9 14.9 16 % 300.1 257.8 42.3 16 %
Naglazyme (2) 72.1 77.8 (5.7) (7) % 238.4 221.6 16.8 8 %
Vimizim (2) 90.3 80.9 9.4 12 % 299.3 260.3 39.0 15 %
Net Product Revenues 298.8 278.3 20.5 7 % 916.9 812.2 104.7 13 %
Royalty and Other Revenues 35.3 1.6 33.7 38.4 4.6 33.8
Total Revenues $ 334.1 $ 279.9 $ 54.2 19 % $ 955.3 $ 816.8 $ 138.5 17 %
(1) Kuvan revenue growth was driven by a 9% increase in the number of commercial patients on Kuvan therapy in the U.S. and continued growth in the ex-North American territories acquired in 2016.
(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 September 30, Nine Months Ended September 30,
2017 2016 $ Change % Change 2017 2016 $ Change % Change
Aldurazyme revenue reported by Genzyme $ 58.4 $ 58.9 $ (0.5) (1) % $ 176.3 $ 168.5 $ 7.8 5 %
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 $ Change 2017 2016 $ Change
Royalties earned from Genzyme $ 24.5 $ 26.9 $ (2.4) $ 74.2 $ 71.2 $ 3.0
Net product transfer revenues (3) (2.1) (3.2) 1.1 (12.5) (12.4) (0.1)
Total Aldurazyme net product revenues $ 22.4 $ 23.7 $ (1.3) $ 61.7 $ 58.8 $ 2.9
2017 Financial Guidance
Full-year Revenue Guidance ($ in millions)
Item
Provided August 2, 2017 Updated October 26, 2017
Total Revenues $1,285 to $1,335 $1,290 to $1,320
Kuvan Net Product Revenues $380 to $410 $400 to $420
Naglazyme Net Product Revenues $300 to $330 $310 to $330
Vimizim Net Product Revenues $400 to $430 $400 to $420
Select Full-year Income Statement Guidance ($ in millions, except percentages)
Item
Provided August 2, 2017 Updated October 26, 2017
Cost of Sales (% of Total Revenues) 17.5% to 18.5% 17.5% to 18.5%
Research and Development Expense $610 to $640 $600 to $620
Selling, General and Admin. Expense $530 to $560 $530 to $550
GAAP Net Loss $(115) to $(155) $(110) to $(130)
Non-GAAP Income $30 to $70 $60 to $80
Key Program Updates at R&D Day October 18, 2017
Conference Call Details
BioMarin will host a conference call and webcast to discuss third quarter 2017 financial results today, Thursday, October 26, 2017 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 International Dial-in Number: 574.990.1362 Conference ID: 96054850
Replay Dial-in Number: 855.859.2056 Replay International Dial-in Number: 404.537.3406 Conference ID: 96054850
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 ® , Vimizim, Naglazyme ® , Kuvan ® and Firdapse ® 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
September 30, 2017 and December 31, 2016
(In thousands of U.S. dollars, except share and per share amounts)
September 30, 2017 December 31, 2016(1)
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 431,399 $ 408,330
Short-term investments 825,700 381,347
Accounts receivable, net 251,891 215,280
Inventory 457,393 355,126
Other current assets 83,646 61,708
Total current assets 2,050,029 1,421,791
Noncurrent assets:
Long-term investments 416,304 572,711
Property, plant and equipment, net 878,624 798,768
Intangible assets, net 530,957 553,780
Goodwill 197,039 197,039
Deferred tax assets 484,759 446,786
Other assets 22,985 32,815
Total assets $ 4,580,697 $ 4,023,690
LIABILITIES AND STOCKHOLDERS ' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $ 364,920 $ 370,505
Short-term convertible debt, net — 22,478
Short-term contingent acquisition consideration payable 52,609 46,327
Total current liabilities 417,529 439,310
Noncurrent liabilities:
Long-term convertible debt, net 1,166,036 660,761
Long-term contingent acquisition consideration payable 126,790 115,310
Other long-term liabilities 56,780 42,034
Total liabilities 1,767,135 1,257,415
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 shares authorized; 175,495,350 and 172,647,588 shares issued and outstanding as of September 30, 2017 and December 31, 2016, respectively. 176 173
Additional paid-in capital 4,435,449 4,288,113
Company common stock held by Nonqualified Deferred Compensation Plan (14,473) (14,321)
Accumulated other comprehensive income (loss) (21,434) 12,816
Accumulated deficit (1,586,156) (1,520,506)
Total stockholders' equity 2,813,562 2,766,275
Total liabilities and stockholders' equity $ 4,580,697 $ 4,023,690
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three and Nine Months Ended September 30, 2017 and 2016
(In thousands of U.S. dollars, except per share amounts)
(Unaudited)
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
REVENUES:
Net product revenues $ 298,752 $ 278,262 $ 916,868 $ 812,195
Royalty and other revenues 35,396 1,634 38,473 4,568
Total revenues 334,148 279,896 955,341 816,763
OPERATING EXPENSES:
Cost of sales 59,480 50,738 165,791 145,473
Research and development 154,103 160,831 442,145 486,663
Selling, general and administrative 130,532 118,758 394,056 333,635
Intangible asset amortization and contingent consideration 3,760 9,654 26,096 (34,318)
Impairment of intangible assets — — — 599,118
Total operating expenses 347,875 339,981 1,028,088 1,530,571
LOSS FROM OPERATIONS (13,727) (60,085) (72,747) (713,808)
Equity in the loss of BioMarin/Genzyme LLC (253) (104) (996) (374)
Interest income 3,976 1,633 10,031 4,561
Interest expense (10,884) (9,980) (31,043) (29,767)
Other income, net 267 1,723 4,282 504
LOSS BEFORE INCOME TAXES (20,621) (66,813) (90,473) (738,884)
Benefit from income taxes (8,094) (29,388) (24,823) (199,394)
NET LOSS $ (12,527) $ (37,425) $ (65,650) $ (539,490)
NET LOSS PER SHARE, BASIC $ (0.07) $ (0.22) $ (0.38) $ (3.29)
NET LOSS PER SHARE, DILUTED $ (0.07) $ (0.22) $ (0.38) $ (3.30)
Weighted average common shares outstanding, basic 175,103 167,714 174,071 163,963
Weighted average common shares outstanding, diluted 175,103 167,714 174,071 164,216
Non-GAAP Information
The results presented in this press release for the three and nine months ended September 30, 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 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 Nine Months Ended Year Ending
September 30, September 30, December 31, 2017
2017 2016 2017 2016 Guidance
GAAP Net Loss $ (12.5) $ (37.4) $ (65.7) $ (539.5) $(130) - $(110)
Interest expense, net 6.9 8.3 21.0 25.2 30
Benefit from income taxes (8.1) (29.4) (24.8) (199.4) (20) - (50)
Depreciation expense 13.3 18.8 36.9 42.7 45 - 55
Amortization expense 7.6 7.5 22.7 22.6 30
Stock-based compensation expense 35.9 32.9 106.7 97.3 130 - 150
Contingent consideration expense (1) (3.8) 2.2 3.4 (56.9) 10
Impairment charges (2) — — — 599.1 -
Royalty and other revenues (3) (31.5) — (31.5) — (35)
Non-GAAP Income (Loss) $ 7.8 $ 2.9 $ 68.7 $ (8.9) $60 - $80
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 September 30,
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 (3) $ 35.4 $ — $ (31.5) $ 3.9 $ 1.6 $ — $ — $ 1.6
Cost of sales 59.5 — (3.0) 56.5 50.7 — (2.1) 48.6
Research and development 154.1 (7.6) (13.8) 132.7 160.8 (11.1) (14.2) 135.5
Selling, general and administrative 130.5 (5.7) (19.1) 105.7 118.8 (7.7) (16.6) 94.5
Intangible asset amortization and contingent consideration (1) 3.8 (7.6) 3.8 — 9.7 (7.5) (2.2) —
Impairment of intangible assets (2) — — — — — — — —
Interest expense, net (6.9) 6.9 — — (8.3) 8.3 — —
Benefit from income taxes (8.1) 8.1 — — (29.4) 29.4 — —
GAAP Net Loss/Non-GAAP Income (Loss) (12.5) 19.7 0.6 7.8 (37.4) 5.2 35.1 2.9
Nine Months Ended September 30,
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 (3) $ 38.5 $ — $ (31.5) $ 7.0 $ 4.6 $ — $ — $ 4.6
Cost of sales 165.8 — (7.8) 158.0 145.5 — (6.0) 139.5
Research and development 442.1 (20.2) (40.0) 381.9 486.7 (23.4) (43.0) 420.3
Selling, general and administrative 394.1 (16.7) (58.9) 318.5 333.6 (19.3) (48.3) 266.0
Intangible asset amortization and contingent consideration (1) 26.1 (22.7) (3.4) — (34.3) (22.6) 56.9 —
Impairment of intangible assets (2) — — — — 599.1 — (599.1) —
Interest expense, net (21.0) 21.0 — — (25.2) 25.2 — —
Benefit from income taxes (24.8) 24.8 — — (199.4) 199.4 — —
GAAP Net Loss/Non-GAAP Income (Loss) (65.7) 55.8 78.6 68.7 (539.5) (108.9) 639.5 (8.9)
1. Amounts for the three and nine months ended September 30, 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.
2. Amounts or the three and nine months ended September 30, 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. 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.

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Last updated: Oct 26, 2017