BioMarin Announces Full Year and Fourth Quarter 2018 Results
SAN RAFAEL, Calif., Feb. 21, 2019 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended December 31,
Twelve Months Ended December 31,
2018 2017 % 2018 2017
%
Change Change
Total Revenues $
353.2 $
358.3 (1)% $
1,491.2 $
1,313.6 14%
Vimizim Net Product
Revenues 114.0 114.0 0% 482.0 413.3 17%
Kuvan Net Product Revenues 112.2 107.4 4% 433.6 407.5 6%
Naglazyme Net Product
Revenues 76.7 93.8 (18)% 345.9 332.2 4%
Aldurazyme Net Product
Revenues 17.4 28.3 (39)% 135.1 90.0 50%
Brineura Net Product
Revenues 12.2 5.2 135% 39.9 8.6 364%
Palynziq Net Product
Revenues 8.1 n/a 12.2
n/a
GAAP Net Loss $
(3.6) $
(51.4) $
(77.2) $
(117.0)
GAAP Net Loss per Share -
Basic $
(0.02) $
(0.29) $
(0.44) $
(0.67)
GAAP Net Loss per Share -
Diluted $
(0.03) $
(0.30) $
(0.44) $
(0.67)
Non-GAAP Income (Loss) (1) $
(10.8) $
5.2 $
90.9 $
74.0
December 31, December
31,
2018 2017
Cash, cash equivalents and
investments $
1,320.2 $
1,781.7
(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.
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
Generally Accepted Accounting
Principles in the United States
(US GAAP).
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) today announced financial results for the full year and fourth quarter of 2018. Net Loss for 2018 decreased $39.8 million or 34%, to $77.2 million, compared to $117.0 million in 2017. Net Loss for the quarter ended December 31, 2018 decreased to $3.6 million, compared to Net Loss of $51.4 million, for same period in 2017.
The change in Net Loss for the full year and fourth quarter of 2018, compared to the same periods in 2017 was primarily due to the following:
-- a year over year increase in gross profits of $104.0 million driven by
increased sales volume across all of our products, a $4.1 million
quarter over quarter decrease in gross profits driven by a decrease in
Aldurazyme sales volume; and
-- an increase in the benefit from income taxes. During 2018, the Company
recognized a $65.5 million benefit from income taxes primarily
attributed to Orphan Drug Credits earned in the year, whereas in 2017 it
recognized income tax expense of $81.2 million primarily driven by U.S.
tax reform; partially offset by
-- higher research and development (R&D) expense for the expansion of
BioMarin's clinical programs related to valoctocogene roxaparvovec,
vosoritide and tralesinidase alfa and higher selling, general and
administrative (SG&A) expense in support of the U.S. commercial launch
of Palynziq and European (EU) pre-launch activities, the continued
commercial expansion of Brineura and market preparation activities
related to the Company's valoctocogene roxaparvovec product candidate;
and
-- a decrease in the gain on the sale of intangible assets. During the
third and fourth quarters of 2018, the Company received milestone
payments of $20.0 million and $30.0 million, respectively. The milestone
payments were triggered by a third-party's attainment of development and
regulatory approval milestones related to a previously sold intangible
asset. In 2017, BioMarin sold the Priority Review Voucher it received in
connection with the FDA approval of Brineura and recognized the $125.0
million of proceeds as a gain on the sale of intangible assets.
Non-GAAP Income for 2018 increased $16.9 million, or 23%, to $90.9 million, compared to $74.0 million in 2017. Non-GAAP Loss for the quarter ended December 31, 2018 was $10.8 million, compared to Non-GAAP Income of $5.2 million in the quarter ended December 31, 2017. The change in Non-GAAP Income/Loss for the full year 2018 was attributed to increased gross profit from sales partially offset by higher expenses as described above. The change in Non-GAAP Income/Loss quarter to quarter was attributed to decreased gross profit and higher expenses as described above.
Net product revenues for 2018 increased 14% to $1.5 billion, compared to $1.3 billion in 2017. The increase in net product revenues for the full year, is attributed to increased sales across all of our products despite quarter to quarter volatility driven by central government ordering patterns. The increase by product was:
-- Vimizim: increased $68.7 million, or 17%, primarily driven by new
patients initiating therapy and government ordering patterns;
-- Aldurazyme: increased $45.1 million, or 50%, of which $20.2 million is
due to the different revenue recognition principles applied as a result
of BioMarin's adoption of Accounting Standards Codification 606, Revenue
from Contracts with Customers, (ASC 606), and $24.9 million due an
increase in sales volume;
-- Brineura: contributed $31.3 million to increased net product revenues,
primarily attributed to new patients initiating therapy as the product
was commercially launched in mid-2017;
-- Kuvan: increased $26.1 million, or 6%, primarily due to an increase in
patients initiating therapy in North America;
-- Naglazyme: increased $13.7 million, or 4%, primarily driven by new
patients initiating therapy in Turkey and North America and government
ordering patterns in the Middle East, partially offset by a decrease due
to the impact of government ordering patterns from certain Latin
American countries; and
-- Palynziq: received approval from the U.S. Food and Drug Administration
(FDA) in May 2018, with commercial sales launching in the third quarter
of 2018. Palynziq net product revenues in 2018 totaled $12.2 million
primarily driven by the conversion of clinical patients to commercial
Palynziq in the U.S.
Net product revenues for the fourth quarter of 2018 were $347.2 million, compared to $353.6 million in the fourth quarter of 2017. The decrease in net product revenues in the fourth quarter of 2018 compared to the fourth quarter of 2017 was primarily attributed to decreased Naglazyme net product revenues driven by the volatility of central government ordering patterns and lower Aldurazyme sales volume driven by timing of shipments to Genzyme, partially offset by the first full quarter of Palynziq commercial sales and increased Brineura net product revenues.
As of December 31, 2018, BioMarin had cash, cash equivalents and investments totaling approximately $1.3 billion, as compared to $1.8 billion on December 31, 2017. On October 15, 2018, our 0.75% senior subordinated convertible notes matured and were settled with a combination of $375.0 million in cash for the full principal amount and cash in lieu of fractional shares plus the issuance of 190,220 common stock for the conversion value in excess of the principal.
Commenting on 2018 results, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "BioMarin's achievements over the last 12 months have prepared us for a number of key catalysts across the product portfolio in 2019. In the second quarter of 2018, we received FDA approval of Palynziq, an important new therapy that helps address a significant unmet need in adults with phenylketonuria (PKU). As of February 15, 2019, 335 PKU patients were being treated in the U.S. with reimbursed Palynziq. Looking forward, we expect to hear the status of our European marketing authorization application in the first quarter of 2019. We are hopeful that PKU patients in the European Union will have the opportunity to benefit from Palynziq should we receive approval in that region later this year."
"In May, we provided two years of clinical data from the Phase 2 study with the 6e13 vg/kg dose of valoctocogene roxaparvovec gene therapy for severe hemophilia A that demonstrated the elimination of need for prophylaxis and no spontaneous bleeds. In addition, we amended the protocol of the global GENEr8-1 (Phase 3) pivotal study by increasing the number of participants from 40 to 130 in order to evaluate superiority compared to the current standard of care. We now anticipate completing enrollment during the third quarter of 2019. Based on draft guidance from the FDA for hemophilia gene therapy products published in 2018, we communicated our interest in exploring a potential accelerated approval pathway with valoctocogene roxaparvovec. We plan to decide in the second half of 2019 whether we will pursue an accelerated approval path."
Mr. Bienaimé continued, "In November of 2018, we showcased a number of our other pipeline and research programs at BioMarin's annual Research and Development Day. Specifically, we provided a 42-month update on vosoritide for the treatment of achondroplasia that our ongoing Phase 2 study demonstrated an average additional cumulative height gain of 5.7 centimeters. Based on these results, we are encouraged that vosoritide could potentially be the first approved treatment option for children with achondroplasia. Finally, we were pleased to share initial pre-clinical data for BMN 307, our gene therapy product for PKU, which demonstrated lifetime normalization of Phe in a validated PKU mouse model. We plan to complete preclinical studies in the first half of 2019 with an anticipated IND filing planned for the second half of 2019."
Full-Year 2019 Financial Guidance (in millions, except %)
Item 2019 Guidance
---
Total Revenues $1,680 to $1,750
Vimizim Net Product Revenues $530 to $570
Kuvan Net Product Revenues $420 to $460
Naglazyme Net Product Revenues $350 to $380
Palynziq Net Product Revenues $70 to $100
Brineura Net Product Revenues $55 to $75
Cost of Sales (% of Total
Revenues) 20% to 21%
Research and Development Expense $740 to $780
Selling, General and Admin.
Expense $650 to $690
GAAP Net Loss $(45) to $(85)
Non-GAAP Income * $130 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 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.
Key Program Highlights
-- Palynziq for PKU: With the approval in May 2018 of Palynziq in the
United States, an injection to reduce blood Phe concentrations in adult
patients with PKU, BioMarin added its seventh commercial product to its
portfolio. As of February 15, 2019, 335 patients were on reimbursed
Palynziq, with an additional 131 patients enrolled and awaiting their
first treatment with commercial Palynziq. Of the 125 PKU clinics in the
U.S., 80 had at least one complete patient enrollment in the REMS
program as of February 15, 2019. BioMarin anticipates an opinion from
the Committee for Medicinal Products for Human Use (CHMP), the
scientific committee of the European Medicines Agency (EMA), on Palynziq
in the first quarter of 2019. If the CHMP provides a positive opinion in
the first quarter of 2019, then in the second quarter of 2019, it is
possible that the European Commission (EC) could provide marketing
authorization in the European Union.
-- Valoctocogene roxaparvovec gene therapy for hemophilia A: In May 2018,
the Company updated the protocol for the Phase 3 GENEr8-1 study
evaluating the 6e13 vg/kg dose and has statistically powered the study
results to evaluate superiority to the current standard of care, Factor
VIII prophylaxis. The Phase 3 GENEr8-1 study will include 130
participants and is expected to be fully enrolled in the third quarter
of 2019.Draft guidelines published by the FDA in 2018 on the development
of gene therapy products for the treatment of hemophilia outlined a
potential accelerated approval path forward applicable to valoctocogene
roxaparvovec. The Company announced in January 2019 that it had
completed enrollment of the initial cohort of patients in its Phase 3
program that would be included in a potential accelerated submission.
The Company plans to decide in the second half of 2019 whether it will
submit a Biologics License Application through an accelerated approval
pathway.
-- Vosoritide for children with achondroplasia: On November 7, 2018, the
Company provided a 42-month update for vosoritide at R&D Day 2018. Data
from the children in the ongoing Phase 2 study demonstrated an average
of 5.7 centimeters of cumulative additional height gained at 42 months.
BioMarin expects to have over 5 years of clinical data from this study
to corroborate maintenance of effect at the time of possibly filing for
marketing authorization. The vosoritide development program includes
four distinct areas of focus to support global approval, including a
large contemporaneous natural History study which is underway. The
global Phase 3 study, which is fully enrolled, is a randomized,
placebo-controlled study of vosoritide in approximately 110 children
with achondroplasia between the ages of 5 to 14 years. BioMarin expects
top line results from the 52-week Phase 3 study by year end 2019. Also
in 2018, BioMarin began its global Phase 2 study with vosoritide in
infants and young (less than 60 months old) children with
achondroplasia, to determine the impact of treatment in this age group.
-- Tralesinidase alfa (formerly referred to as BMN 250) for MPS IIIB
(Sanfilippo Syndrome, Type B): In February 2019, the Company provided an
update at the Society for the Study of Inborn Errors of Metabolism
(SSIEM) meeting from the Phase 1/2 trial with tralesinidase alfa. Of the
seven subjects who have been treated with the 300 mg/kg weekly dose,
heparan sulfate levels were normalized in the brain fluid. All subjects
also experienced normalization of the enlargement of their liver and
spleen. Development Quotient (DQ), a measure of cognitive function
normalized to age, was also monitored. Five of the seven subjects have
experienced encouraging trends in brain function based on DQ measures.
-- BMN 307 gene therapy product candidate for phenylketonuria (PKU): The
Company expects to submit an investigational new drug application (IND)
and/or a clinical trial application (CTA) for a gene therapy product for
the treatment of PKU in the second half of 2019. At R&D Day 2018,
BioMarin shared data with BMN 307 that demonstrated a lifetime Phe
correction sustained at 80 weeks in preclinical mouse models. BMN 307 is
an AAV vector containing the DNA sequence that codes for the
phenylalanine hydroxylase enzyme that is deficient in people with PKU.
-- BMN 290 for Friedreich's Ataxia: BMN 290 is a selective chromatin
modulation therapy intended for the treatment of Friedreich's ataxia.
Currently, there are no approved disease modifying therapies for
Friedreich's ataxia. The Company is currently conducting additional
pre-clinical work on BMN 290 and will decide in the first half of 2019
whether to file an IND based on the outcome of those data.
BioMarin will host a conference call and webcast to discuss fourth quarter 2018 financial results today, Thursday, February 21, 2019 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: 8265006
Conference ID: 8265006
---
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 several approved products and multiple clinical and pre-clinical 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, GAAP Net Loss, Non-GAAP Income (Loss) and other specified income statement guidance; the financial performance of BioMarin as a whole; BioMarin's potential for growth, BioMarin's commercial prospects, including the timing of (i) decisions by regulators, including the European Commission's decision regarding BioMarin's Marketing Authorization Application for Palynziq, (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 (iv) announcements of data from those studies and trials, including BioMarin's Phase 3 program and Phase 1/2 study with valoctocogene roxaparvovec; the ongoing Phase 2 and Phase 3 studies of vosoritide and the Phase 1/2 study of tralesinidase alfa (formerly referred to as BMN 250); the continued clinical development and commercialization of BioMarin's commercial products and product candidates, including (i) BioMarin's plans to potentially decide in the first half of 2019 whether to file an IND for BMN 290 and potentially file an IND and/or a CTA for its new gene therapy candidate for the treatment of PKU in the second half of 2019; (ii) statements regarding the timing of BioMarin's decision on whether or not to pursue an accelerated approval pathway for valoctocogene roxaparvovec and (iii) statements regarding BioMarin's encouragement that vosoritide could potentially be the first approved treatment option for children with achondroplasia; the possible approval and commercialization of BioMarin's product candidates. 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; Genzyme Corporation's success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical 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 September 30, 2018 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.
Contacts:
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
December 31, 2018 and 2017
(In thousands of U.S. dollars, except share and per share amounts)
December 31, 2018 December 31, 2017
(1) (2)
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $
493,982 $
598,028
Short-term investments 590,326 797,940
Accounts receivable, net 342,633 261,365
Inventory 530,871 475,775
Other current assets 98,403 74,036
Total current assets 2,056,215 2,207,144
Noncurrent assets:
Long-term investments 235,864 385,785
Property, plant and equipment, net 948,682 896,700
Intangible assets, net 491,808 517,510
Goodwill 197,039 197,039
Deferred tax assets 460,952 399,095
Other assets 36,568 29,852
Total assets $
4,427,128 $
4,633,125
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $
437,290 $
401,921
Short-term convertible debt, net 360,949
Short-term contingent consideration 85,951 53,648
Total current liabilities 523,241 816,518
Noncurrent liabilities:
Long-term convertible debt, net 830,417 813,521
Long-term contingent consideration 46,883 135,318
Other long-term liabilities 58,647 59,105
Total liabilities 1,459,188 1,824,462
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 shares
authorized;
178,252,954 and
175,843,749 shares issued and outstanding,
respectively. 178 176
Additional paid-in capital 4,669,926 4,483,220
Company common stock held by Nonqualified Deferred
Compensation Plan (13,301) (14,224)
Accumulated other comprehensive income (loss) 5,271 (22,961)
Accumulated deficit (1,694,134) (1,637,548)
Total stockholders' equity 2,967,940 2,808,663
Total liabilities and stockholders' equity $
4,427,128 $
4,633,125
(1) As of January 1, 2018, the
Company adopted the requirements
of Accounting Standards
Codification 606, Revenue from
Contracts with Customers (ASC
606), using the modified
retrospective method, and as a
result, Accounts Receivable and
Deferred Tax Assets are not
comparable to the prior periods
presented.
(2) December 31, 2017 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, 2017, filed with the U.S.
Securities and Exchange
Commission (SEC) on February 26,
2018.
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three and Twelve Months Ended December 31, 2018 and 2017
(In thousands of U.S. dollars, except per share amounts)
Three Months Ended December 31, Twelve Months Ended December 31,
2018 (1) 2017 2018 (1) 2017 (2)
(unaudited) (unaudited) (unaudited)
REVENUES:
Net product revenues $
347,151 $
353,577 $
1,470,356 $
1,270,445
Royalty and other revenues 6,063 4,728 20,856 43,201
Total revenues 353,214 358,305 1,491,212 1,313,646
OPERATING EXPENSES:
Cost of sales 75,019 75,995 315,264 241,786
Research and development 175,390 168,608 696,328 610,753
Selling, general and administrative 164,171 160,280 604,353 554,336
Intangible asset amortization and
contingent
consideration 6,782 20,375 48,791 46,471
Gain on sale of intangible assets (30,000) (125,000) (50,000) (125,000)
Total operating expenses 391,362 300,258 1,614,736 1,328,346
INCOME (LOSS) FROM OPERATIONS (38,148) 58,047 (123,524) (14,700)
Equity in the loss of BioMarin/Genzyme
LLC (46) (295) (553) (1,291)
Interest income 5,690 4,822 22,831 14,853
Interest expense (7,746) (11,664) (43,664) (42,707)
Other income, net (3,061) 3,688 2,205 7,970
LOSS BEFORE INCOME TAXES (43,311) 54,598 (142,705) (35,875)
Provision for (benefit from) income
taxes (39,661) 105,990 (65,494) 81,167
NET LOSS $
(3,650) $
(51,392) $
(77,211) $
(117,042)
NET LOSS PER SHARE, BASIC $
(0.02) $
(0.29) $
(0.44) $
(0.67)
NET LOSS PER SHARE, DILUTED $
(0.03) $
(0.30) $
(0.44) $
(0.67)
Weighted average common shares
outstanding, basic 177,936 175,485 177,061 174,427
Weighted average common shares
outstanding, dilutive 178,143 175,705 177,268 174,427
(1) As of January 1, 2018, the
Company adopted the requirements
of ASC 606 using the modified
retrospective method, and as a
result, Net Product Revenues are
not comparable to the prior
periods presented.
(2) December 31, 2017 totals 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, 2017, filed with the SEC on
February 26, 2018.
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 (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, 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 Loss for each of the periods presented. In this regard, Non-GAAP Income (Loss) 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 (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. BioMarin also uses Non-GAAP Income (Loss) 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 (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
Guidance
December 31, December 31, Year Ending
---
2018 2017 2018 2017 December 31, 2019
---
GAAP Net Loss $
(3.6) $
(51.4) $
(77.2) $
(117.0) $
(45.0) - $
(85.0)
Interest expense, net 2.1 6.8 20.8 27.9 - 10.0
Provision for (Benefit from)
income taxes (39.7) 106.0 (65.5) 81.2 (50.0) - (30.0)
Depreciation expense 17.1 14.8 65.2 51.7 45.0 - 60.0
Amortization expense 7.6 13.4 30.3 36.2 40.0 - 55.0
Stock-based compensation
expense 36.5 33.6 148.8 140.2 150.0 - 175.0
Contingent consideration
expense (0.8) 7.0 18.5 10.3 20.0 - 30.0
Gain on sale of intangible
assets (30.0) (125.0) (50.0) (125.0) (30.0) - (45.00)
Royalty and other revenues (31.5) -
Non-GAAP Income
(Loss) $
(10.8) $
5.2 $
90.9 $
74.0 $
130.0 - $
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 December 31,
2018 2017
---
Adjustments
Adjustments
GAAP Interest, Stock-Based Non- GAAP Interest, Stock-Based Non-
Taxes, Compensation, GAAP Reported Taxes, Compensation, GAAP
Reported Depreciation Contingent Depreciation Contingent
and Consideration and Consideration
Amortization and Other Amortization and Other
Adjustments Adjustments
---
Cost of sales $
75.0
$ $
(3.1) $
71.9 $
76.0
$ $
(2.8) $
73.2
Research and development 175.4 (11.2) (14.5) 149.7 168.6 (8.0) (13.2) 147.4
Selling, general and
administrative 164.2 (5.9) (18.9) 139.4 160.3 (6.8) (17.6) 135.9
Intangible asset amortization
and contingent
consideration 6.8 (7.6) 0.8 20.4 (13.4) (7.0)
Gain on sale of intangible
assets (30.0) 30.0 (125.0) 125.0
Interest expense, net (2.1) 2.1 (6.8) 6.8
Provision for (Benefit from)
income taxes (39.7) 39.7 106.0 (106.0)
GAAP Net Loss/
Non-GAAP Income (Loss) (3.6) (12.9) 5.7 (10.8) (51.4) 141.0 (84.4) 5.2
Twelve Months Ended December 31,
2018 2017
---
Adjustments
Adjustments
GAAP Interest, Stock-Based Non- GAAP Interest, Stock-Based Non-
Reported Taxes, Compensation, GAAP Reported Taxes, Compensation, GAAP
Depreciation Contingent Depreciation Contingent
and Consideration and Consideration
Amortization and Other Amortization and Other
Adjustments Adjustments
---
Royalty and other
revenues $
20.9
$
$ $
20.9 $
43.2
$ $
(31.5) $
11.7
Cost of sales 315.3 (13.5) 301.8 241.8 (10.6) 231.2
Research and development 696.3 (36.6) (57.6) 602.1 610.8 (28.2) (53.1) 529.5
Selling, general and
administrative 604.4 (28.6) (77.7) 498.1 554.3 (23.5) (76.5) 454.3
Intangible asset amortization
and contingent
consideration 48.8 (30.3) (18.5) 46.5 (36.2) (10.3)
Gain on sale of intangible
assets (50.0) 50.0 (125.0) 125.0
Interest expense, net (20.8) 20.8 (27.9) 27.9
Provision for (Benefit from)
income taxes (65.5) 65.5 81.2 (81.2)
GAAP Net Loss/Non-GAAP
Income (77.2) 50.8 117.3 90.9 (117.0) 197.0 (6.0) 74.0
View original content to download multimedia:http://www.prnewswire.com/news-releases/biomarin-announces-full-year-and-fourth-quarter-2018-results-300799976.html
SOURCE BioMarin Pharmaceutical Inc.
