BioMarin Announces Third Quarter 2017 Financial Results
- Company Announces Total Revenues of $334.1 million in the Third Quarter of 2017; Full-year Revenue Guidance Confirmed at between $1.29 billion and $1.32 billion
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[26-October-2017] |
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 % 2017 2016 % Change 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 (1) Non-GAAP income (loss) is defined by the Company as reported 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. 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 GAAP reported information. BioMarin Pharmaceutical Inc. 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 % 2017 2016 $ Change % 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 % 2017 2016 $ Change % 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 $2.9 ===== ===== ===== ===== ===== ==== (3) To the extent units shipped to third party customers by Genzyme exceed BioMarin inventory transfers to Genzyme, BioMarin will record a decrease in net product revenues from the amounts payable to BioMarin for the amount of previously recognized product transfer revenue. If BioMarin inventory transfers exceed units shipped to third party customers by Genzyme, BioMarin will record incremental net product transfer revenues for the period. Positive net product transfer revenues result in the period if BioMarin transferred more units to Genzyme than Genzyme sold to third-party customers.
2017 Financial Guidance ----------------------- Full-year Revenue Guidance ($ 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 Replay Dial-in Number: 855.859.2056 About BioMarin Forward-Looking Statement BioMarin®, Brineura®, Vimizim, Naglazyme®, Kuvan® and Firdapse® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. KyndrisaTM 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, December 31, 2017 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 ========== ========== (1) December 31, 2016 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, 2016, filed with the U.S. Securities and Exchange Commission on February 27, 2017.
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. 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 (Loss) 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. 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 Interest, Royalty and Non- GAAP Interest, Royalty and Non- Reported Taxes, Other GAAP Taxes, Other GAAP Depreciation Revenues, Reported Depreciation Revenues, and Stock-Based and Stock-Based Amortization Compensation, Amortization Compensation, Contingent Contingent Consideration Consideration and Other and Other Adjustments Adjustments --- 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 (12.5) 19.7 0.6 7.8 (37.4) 5.2 35.1 2.9 (Loss) Nine Months Ended September 30, ------------------------------- 2017 2016 ---- ---- Adjustments Adjustments ----------- ----------- GAAP Interest, Royalty and Non- GAAP Interest, Royalty and Non- Reported Taxes, Other GAAP Reported Taxes, Other GAAP Depreciation Revenues, Depreciation Revenues, and Stock-Based and Stock-Based Amortization Compensation, Amortization Compensation, Contingent Contingent Consideration Consideration and Other and Other Adjustments Adjustments --- 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 (65.7) 55.8 78.6 68.7 (539.5) (108.9) 639.5 (8.9) (Loss) 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
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Company Codes: NASDAQ-NMS:BMRN |