BioMarin Pharmaceutical Inc. today announced financial results for the fourth quarter and year ended December 31, 2017.
|
SAN RAFAEL, Calif., Feb. 22, 2018 /PRNewswire/ -- 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." 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: Replay International Dial-in
574.990.1362 Number: 404.537.3406
----------------------------- -----------------------------
Conference ID: 5289587 Conference ID: 5289587
---------------------- ----------------------
About BioMarin Forward-Looking Statement BioMarin®, Brineura®, Firdapse®, Kuvan®, Naglazyme® and Vimizim® 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
December 31, 2017 and December 31, 2016
(In thousands of U.S. dollars, except share and per share amounts)
December 31, December 31,
2017 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
========== ==========
(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 Twelve Months Ended December 31, 2017 and 2016
(In thousands of U.S. dollars, except per share amounts)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, 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. 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 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 Interest, Royalty and Non- GAAP Interest, Royalty and Non-
Taxes, Other GAAP Taxes, Other GAAP
Reported Depreciation Revenues, Reported Depreciation Revenues,
and Stock-Based and
Amortization Compensation, Amortization Stock-Based
Contingent Compensation,
Consideration Contingent
and Other Consideration
Adjustments and Other
Adjustments
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 Interest, Royalty and Non- GAAP Interest, Royalty and Non-
Taxes, Other GAAP Taxes, Other GAAP
Reported 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 (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.
Primarily represents the one-time
upfront payment related to the License
and Settlement Agreement entered into
with Sarepta Therapeutics, Inc. in July
4. 2017.
Contact:
Investors: Media:
Traci McCarty Debra Charlesworth
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 455-7558 (415) 455-7451
View original content with multimedia:http://www.prnewswire.com/news-releases/biomarin-announces-fourth-quarter-and-full-year-2017-financial-results-300603042.html SOURCE BioMarin Pharmaceutical Inc. |
Company Codes: NASDAQ-NMS:BMRN |
