SAN RAFAEL, Calif.,
Feb. 23, 2017 /PRNewswire/ --
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Financial
Highlights (in millions of U.S. dollars, except per share data,
unaudited)
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|
Three Months
Ended
December 31,
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Twelve Months
Ended
December 31,
|
|
2016
|
|
2015
|
|
%
Change
|
|
2016
|
|
2015
|
|
%
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total BioMarin
Revenue
|
$
300
|
|
$
228
|
|
32%
|
|
$ 1,117
|
|
$
890
|
|
26%
|
|
Aldurazyme Net
Product Revenue
|
35
|
|
39
|
|
(10)%
|
|
94
|
|
98
|
|
(4)%
|
|
Kuvan Net Product
Revenue
|
90
|
|
65
|
|
38%
|
|
348
|
|
239
|
|
46%
|
|
Naglazyme Net Product
Revenue
|
75
|
|
60
|
|
25%
|
|
297
|
|
303
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|
(2)%
|
|
Vimizim Net Product
Revenue
|
94
|
|
59
|
|
59%
|
|
354
|
|
228
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|
55%
|
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|
|
|
|
|
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GAAP Net Income
(Loss)
|
$
(91)
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|
$
69
|
|
|
|
$
(630)
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|
$
(172)
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GAAP Net Income
(Loss) per Share - Basic
|
$
(0.53)
|
|
$
0.43
|
|
|
|
$ (3.80)
|
|
$ (1.07)
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|
|
|
GAAP Net Income
(Loss) per Share - Diluted
|
$
(0.53)
|
|
$
0.39
|
|
|
|
$ (3.81)
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|
$ (1.07)
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Non-GAAP Loss
(1)
|
$
(27)
|
|
$
(70)
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|
|
|
$
(36)
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|
$
(143)
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|
|
|
|
|
|
|
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|
|
|
|
|
|
December
31, 2016
|
|
December
31, 2015
|
|
|
|
|
|
|
|
|
|
Cash, cash
equivalents and investments
|
$
1,398
|
|
$
1,018
|
|
|
|
|
|
|
|
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(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 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. (NASDAQ: BMRN) today announced
financial results for the fourth quarter and year ended
December 31, 2016. For the quarter
ended December 31, 2016, GAAP net
loss was $91 million, or ($0.53) per basic and diluted share, compared to
GAAP net income of $69 million, or
$0.43 and $0.39 per basic and diluted share, respectively,
for the fourth quarter of 2015. GAAP net loss for the year ended
December 31, 2016 was $630 million, or ($3.80) and ($3.81)
per basic and diluted share, respectively, compared to GAAP net
loss of $172 million, or ($1.07) per basic and diluted share for the year
ended December 31, 2015. The change
in GAAP net loss year over year was primarily due to the impairment
of intangible assets associated with the discontinuance of the
Kyndrisa and reveglucosidase alfa programs in 2016, and the
absence of the gain on the sale of rights to talazoparib in
2015.
Non-GAAP loss for the year ended December
31, 2016 was $36 million,
compared to non-GAAP loss of $143
million for the year ended December
31, 2015. 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 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.
Total BioMarin Revenues were $1.12
billion for the year ended December
31, 2016, an increase of 26% compared to the same period in
2015. For the fourth quarter of 2016, Total BioMarin Revenues were
$300 million, an increase of 32%
compared to the same period in 2015. Vimizim net product revenues
increased to $94 million in the
quarter, a 59% year over year increase, primarily driven by 40%
growth in new patients on Vimizim therapy year over year. For the
fourth quarter of 2016, Naglazyme net product revenues increased to
$75 million, an increase of 25% year
over year. Patients on Naglazyme therapy continue to show
consistent growth with an increase of 9% year over year. For
the fourth quarter of 2016, Kuvan net product revenues increased to
$90 million, a 38% year over year
increase, including $70 million
contributed from revenue in North
America. Growth was driven by a 15% increase in patients on
Kuvan therapy in North America,
and $20 million contributed from net
product revenues in ex-North American territories newly acquired in
2016.
As of December 31, 2016, BioMarin
had cash, cash equivalents and investments totaling $1.4 billion, which includes $713 million of net proceeds from the
August 12, 2016 public offering, as
compared to $1.0 billion on
December 31, 2015.
Commenting on the year, Jean-Jacques Bienaimé, Chairman and
Chief Executive Officer of BioMarin said, "2016 was a
transformational year for BioMarin. Our commercial business topped
$1 billion for the first time while
we concurrently achieved significant clinical and regulatory
milestones across the product pipeline. In the third quarter, we
shared proof-of-concept data with BMN 270 gene therapy, the only
factor VIII product in clinical development for the treatment of
severe Hemophilia A. In addition, our regulatory filings for
approval of Brineura, for the treatment of Batten disease, were
accepted and validated in both the U.S. and EU. With the
Prescription Drug User Fee Act (PDUFA) goal date for an FDA
approval decision of April 27, 2017,
we hope to have an approved treatment option for this devastating
childhood disease in the near future."
Mr. Bienaimé continued, "In addition, in 2016 we moved our
vosoritide program forward based on Phase 2 results in children
ages 5-14 with achondroplasia. At the end of 2016, we initiated a
one-year, randomized, placebo-controlled Phase 3 study in children
with achondroplasia ages 5-14 using a daily 15µg/kg dose. We
recently provided encouraging preliminary results with our earliest
clinical-stage program BMN 250 for the treatment of MPS IIIB, or
Sanfilippo Syndrome, Type B. We are now moving to the expansion
phase of the development program that will assess the impact of
treatment with BMN 250 on the neurocognitive function in this
rapidly progressive pediatric brain disease. Finally, in addition
to the filing of the BLA for pegvaliase for the treatment of
phenylketonuria expected in the second quarter of 2017, we expect
to start to turn the corner to profitability with the achievement
of positive non-GAAP results for the full year 2017."
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Revenues (in
millions of U.S. dollars, unaudited)
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Total BioMarin Revenues
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|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
|
2016
|
|
2015
|
|
$
Change
|
|
%
Change
|
|
2016
|
|
2015
|
|
$
Change
|
|
%
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Aldurazyme
|
|
$
35
|
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$
39
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$
(4)
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-10%
|
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$
94
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$
98
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$
(4)
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-4%
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Kuvan
(1)
|
|
90
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65
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|
25
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38%
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|
348
|
|
239
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|
109
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46%
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Naglazyme
(2)
|
|
75
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|
60
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15
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25%
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|
297
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303
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(6)
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-2%
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Vimizim
(2)
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|
94
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|
59
|
|
35
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59%
|
|
354
|
|
228
|
|
126
|
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55%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Royalty and other revenues
|
|
2
|
|
2
|
|
—
|
|
0%
|
|
6
|
|
5
|
|
1
|
|
20%
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|
|
|
|
|
|
|
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|
|
|
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|
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|
|
|
|
Total BioMarin
revenues
|
|
$
300
|
|
$
228
|
|
$
72
|
|
32%
|
|
$1,117
|
|
$
890
|
|
$
227
|
|
26%
|
|
|
|
|
|
|
|
|
|
|
|
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(1)
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For the twelve months
ended December 31, 2016, Kuvan net product revenues from North
America contributed $272 million with an additional $76 million
coming from the newly acquired ex-North American
territories.
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(2)
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Naglazyme and Vimizim
net product revenues experience quarterly fluctuations primarily
due to the timing of government ordering patterns in certain
countries.
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Details of Net
Product Revenues Attributable to Aldurazyme
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Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
|
2016
|
|
2015
|
|
$
Change
|
|
%
Change
|
|
2016
|
|
2015
|
|
$
Change
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|
%
Change
|
|
Aldurazyme revenue
reported by Genzyme
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|
$
54
|
|
$
54
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|
$
—
|
|
0%
|
|
$
223
|
|
$ 218
|
|
$
5
|
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
December 31,
|
|
|
|
Twelve Months
Ended
December 31,
|
|
|
|
|
2016
|
|
2015
|
|
$
Change
|
|
|
|
2016
|
|
2015
|
|
$
Change
|
|
|
|
Revenues earned based
on Genzyme net sales
|
|
$
27
|
|
$
27
|
|
$
—
|
|
|
|
$
98
|
|
$
96
|
|
$
2
|
|
|
|
Net product transfer
revenues(3)
|
|
$
8
|
|
$
12
|
|
$
(4)
|
|
|
|
$
(4)
|
|
$
2
|
|
$
(6)
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|
|
|
Total
Aldurazyme net product revenues
|
|
$
35
|
|
$
39
|
|
$
(4)
|
|
|
|
$
94
|
|
$
98
|
|
$
(4)
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|
|
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(3)
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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.
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2017 Financial
Guidance
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Revenue Guidance ($
in millions)
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Item
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2017
Guidance
|
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Total BioMarin
Revenues
|
$1,250 to
$1,300
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Kuvan Net Product
Revenues
|
$380 to
$410
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Naglazyme Net Product
Revenues
|
$300 to
$330
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Vimizim Net Product
Revenues
|
$400 to
$430
|
|
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Select Income
Statement Guidance ($ in millions, except
percentages)
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Item
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2017
Guidance
|
|
Cost of Sales (% of
Total BioMarin Revenues)
|
17.5% to
18.5%
|
|
Research and
Development Expense
|
$620 to
$650
|
|
Selling, General and
Admin. Expense
|
$520 to
$550
|
|
GAAP Net
Loss
|
$(140) to
$(180)
|
|
non-GAAP
Income
|
$30 to $70
|
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Key Program
Updates
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•
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BMN 270 gene
therapy product for hemophilia A: Today the Company
announced that in the ongoing Phase 1/2 study, the three additional
patients to be enrolled in the study will be dosed at the same 4 x
1013 vg/kg dose as the 3 most recently enrolled
patients. Consistent with the dosing regimen of the 3 most recently
enrolled patients, the 3 additional patients will be dosed without
prophylactic corticosteroids. In October 2016, the Medicines and
Healthcare Products Regulatory Agency (MHRA) in the United Kingdom
approved continued enrollment into the open-label Phase 1/2 study
of BMN 270 for severe hemophilia A. The agency also approved
the Company's proposed amendments to the study, which included
eliminating the requirement for prophylactic corticosteroids and
increasing potential additional enrollment from up to three
additional patients to up to six additional patients. In the
fourth quarter of 2016, three patients were dosed at 4 x
1013 vg/kg with BMN 270.
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On February 1, 2017,
BioMarin Pharmaceutical Inc. announced that the European Medicines
Agency (EMA) had granted access to its Priority Medicines (PRIME)
regulatory initiative for the company's investigational gene
therapy treatment for severe hemophilia A, BMN 270.
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To be accepted for
PRIME, an investigational therapy has to show its potential to
benefit patients with unmet medical needs based on early clinical
data. BMN 270 gene therapy is the first and only product candidate
for hemophilia A to have received this designation.
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|
On January 9, 2017,
the Company announced an update to its positive interim results of
an open-label Phase 1/2 study with BMN 270. These data were an
update from previously reported results in July 2016. A total of
nine patients with severe hemophilia A received a single dose of
BMN 270, seven of whom have been treated at the highest dose of 6 x
1013 vg/kg.
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|
As of the December 9,
2016 data cutoff, post-treatment follow-up ranges from 34 to 50
weeks. Median Factor VIII levels for the high dose cohort
have been consistently within the normal range from 20 weeks
through 44 weeks of treatment. According to the World Federation of
Hemophilia rankings of severity of hemophilia A, the normal range
of Factor VIII activity levels is between 50%-150%, expressed as a
percentage of normal factor activity in blood. For those
seven patients, as of each patient's most recent reading, six of
seven patients continue to have Factor VIII activity levels above
50% and the seventh continues to be above 15%, which is the mild
range (5%-40%) of hemophilia A.
|
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|
For the six patients
at the high dose and previously on a Factor VIII prophylactic
regimen, the mean annualized bleeding rate dropped 91% from 16.3
before the BMN 270 infusion to 1.5 two weeks after being dosed
(median annualized bleeding rate dropped from 16.5 to 0). For those
same six patients, the mean annualized Factor VIII infusions fell
98% from 136.7 to 2.9 (median annualized Factor VIII infusions fell
from 138.5 to 0).
|
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|
In addition, six of
the seven patients at the high dose as of January 9, 2017 were
within the normal alanine aminotransferase (ALT) range, and one
patient was less than 5% above the upper limit of normal, which is
43 U/L for the central laboratory in this study. At that time all
patients had successfully tapered off of steroids with no lasting
significant impact on Factor VIII expression or ALT
levels.
|
|
|
|
The Company intends
to provide the next program update by the start of the potentially
registration enabling Phase 2b study in 3Q 2017. In addition,
the company is expected to commission its commercial gene therapy
manufacturing facility by mid-2017.
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•
|
Vosoritide for
achondroplasia: On December 12, 2016, the Company announced
that it had initiated a global Phase 3 study for vosoritide, an
analog of C-type Natriuretic Peptide (CNP), in children with
achondroplasia, the most common form of dwarfism. The first child
enrolled in the study was at a site in Australia.
|
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|
The Phase 3 study is
a randomized, placebo-controlled study of vosoritide in
approximately 110 children with achondroplasia ages 5-14 for 52
weeks. The study will be followed by a subsequent open-label
extension. Children in this study will have completed a minimum
six-month baseline study to determine their respective baseline
growth velocity prior to entering the Phase 3 study. Vosoritide is
being tested in children whose growth plates are still open. This
is approximately 25 percent of people with
achondroplasia.
|
|
|
|
The primary endpoint
of the study is the change in growth velocity from baseline over
one year in children treated compared to placebo. The company
also plans to augment the growth velocity data in the Phase 3 study
with assessments of proportionality, functionality and cumulative
growth observed in that study and the ongoing Phase 2
study.
|
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•
|
Brineura for CLN2,
late-infantile form of Batten disease: During the third quarter
of 2016, the Company announced that the U.S. Food and Drug
Administration (FDA) had accepted for review the submission of a
Biologics License Application (BLA) for Brineura, an
investigational therapy to treat children with CLN2 disease, a form
of Batten disease. The PDUFA goal date for a decision is April 27,
2017.
|
|
|
|
The FDA granted
Brineura Priority Review status, which is designated for drugs that
offer major advances in treatment or provide a treatment where no
adequate therapy exists. Brineura was previously granted Orphan
Drug Designation and Breakthrough Therapy Designation by the FDA.
BioMarin also received validation of the Marketing Authorization
Application (MAA) to the EMA for Brineura. Assuming a positive
opinion from the Committee for Medicinal Products for Human Use
(CHMP) and standard assessment timing, a decision from the European
Commission is anticipated by the third quarter of 2017. The EMA
previously granted Brineura Orphan Drug Designation.
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•
|
Pegvaliase for
phenylketonuria (PKU): In March 2016, the
Company announced pivotal results for the Phase 3 PRISM-2
study (formerly referred to as 165-302) with pegvaliase
demonstrating that the primary endpoint of change in blood phe
compared with placebo (p<0.0001) had been met. The pegvaliase
treated group maintained mean blood phe levels at 527.2 umol/L
compared to their Randomized Discontinuation Trial (RDT) baseline
of 503.9 umol/L, whereas the placebo treated group mean blood phe
levels increased to 1385.7 umol/L compared to their RDT baseline of
536.0 umol/L. The treatment effect demonstrated in this study
represents an approximately 62% improvement in blood phe compared
to placebo. Based on the supportive data results, the Company plans
to submit a BLA to the FDA in the second quarter of
2017.
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•
|
BMN 250 for MPS
IIIB (Sanfilippo Syndrome, Type B): On January 9, 2017, the
Company shared preliminary data from the Phase 1/2 program
demonstrating that BMN 250 reduced heparan sulfate, a biomarker in
the cerebrospinal fluid (CSF), in the brain of affected children.
Since sharing these results with 30mg/weekly dose, patients have
been safely escalated to the highest dose of 300mg weekly. The
study will now move to the expansion phase with the highest dose
looking at improvement in neurocognitive function in children with
this rapid and progressive neurodegenerative disease.
|
Conference Call Details
BioMarin will host a conference call and webcast to discuss
fourth quarter and full year 2016 financial results today,
Thursday, February 23, 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: 547.990.1362
Conference ID: 60631310
Replay Dial-in Number: 855.859.2056
Replay International Dial-in Number: 404.537.3406
Conference ID: 60631310
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 five
commercialized products and multiple clinical and pre-clinical
product candidates. For additional information, please
visit www.BioMarin.com.
Forward-Looking Statement
This press release contains
forward-looking statements about the business prospects of BioMarin
Pharmaceutical Inc. (BioMarin), including, without
limitation, statements about: the expectations of total BioMarin
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 potential revenues
and expenses related to BioMarin's product candidates, including
BMN 270, Brineura, pegvaliase, vosoritide and BMN 250; the
financial performance of BioMarin as a whole; the timing of
BioMarin's clinical studies and trials and announcements of data
from those studies and trials; the continued clinical development
and commercialization of BioMarin's commercial products and product
candidates; the possible approval and commercialization of
BioMarin's product candidates; and actions by regulatory
authorities. 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; 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, 2016 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®,
Vimizim®, Naglazyme®, Kuvan®
and Firdapse® are registered trademarks of
BioMarin Pharmaceutical Inc., or its affiliates.
BrineuraTM and KyndrisaTM are trademarks of
BioMarin Pharmaceutical Inc. Aldurazyme® is a registered
trademark of BioMarin/Genzyme LLC.
|
BIOMARIN
PHARMACEUTICAL INC.
|
|
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
December 31, 2016
and December 31, 2015
|
|
(In thousands of
U.S. dollars, except share and per share amounts)
|
|
|
|
December 31,
2016
|
|
December
31,
2015(1)
|
|
ASSETS
|
|
(unaudited)
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
408,330
|
|
$
397,040
|
|
Short-term
investments
|
|
381,347
|
|
195,579
|
|
Accounts receivable,
net (allowance for doubtful accounts: $73 and $93, at December 31,
2016 and 2015, respectively)
|
|
215,280
|
|
164,959
|
|
Inventory
|
|
355,126
|
|
271,683
|
|
Other current
assets
|
|
61,708
|
|
60,378
|
|
Total current
assets
|
|
1,421,791
|
|
1,089,639
|
|
Noncurrent
assets:
|
|
|
|
|
|
Long-term
investments
|
|
572,711
|
|
425,652
|
|
Property, plant and
equipment, net
|
|
798,768
|
|
704,207
|
|
Intangible assets,
net
|
|
553,780
|
|
683,996
|
|
Goodwill
|
|
197,039
|
|
197,039
|
|
Deferred tax
assets
|
|
446,786
|
|
220,191
|
|
Other
assets
|
|
32,815
|
|
408,644
|
|
Total
assets
|
|
$
4,023,690
|
|
$
3,729,368
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
370,505
|
|
392,511
|
|
Short-term
convertible debt, net
|
|
22,478
|
|
—
|
|
Short-term contingent
acquisition consideration payable
|
|
46,327
|
|
52,946
|
|
Total current
liabilities
|
|
439,310
|
|
445,457
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
Long-term convertible
debt, net
|
|
660,761
|
|
662,286
|
|
Long-term contingent
acquisition consideration payable
|
|
115,310
|
|
32,663
|
|
Long-term deferred
tax liabilities
|
|
—
|
|
143,527
|
|
Other long-term
liabilities
|
|
42,034
|
|
44,588
|
|
Total
liabilities
|
|
1,257,415
|
|
1,328,521
|
|
Stockholders'
equity:
|
|
|
|
|
|
Common stock, $0.001
par value: 250,000,000 shares authorized at December 31, 2016 and
2015: 172,647,588 and 161,526,044 shares issued and
outstanding at December 31, 2016 and 2015, respectively.
|
|
173
|
|
162
|
|
Additional paid-in
capital
|
|
4,288,113
|
|
3,414,837
|
|
Company common stock
held by Nonqualified Deferred Compensation Plan
|
|
(14,321)
|
|
(13,616)
|
|
Accumulated other
comprehensive income
|
|
12,816
|
|
21,033
|
|
Accumulated
deficit
|
|
(1,520,506)
|
|
(1,021,569)
|
|
Total stockholders'
equity
|
|
2,766,275
|
|
2,400,847
|
|
Total liabilities and
stockholders' equity
|
|
$
4,023,690
|
|
$
3,729,368
|
|
|
|
(1)
|
December 31, 2015
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, 2015, filed with the U.S. Securities
and Exchange Commission on February 29, 2016.
|
|
BIOMARIN
PHARMACEUTICAL INC.
|
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
Three and Twelve
Months Ended December 31, 2016 and 2015
|
|
(In thousands of
U.S. dollars, except per share amounts)
|
|
(Unaudited)
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
Net product
revenues
|
$298,186
|
|
$226,420
|
|
$1,110,381
|
|
$
884,522
|
|
Royalty, license and
other revenues
|
1,905
|
|
1,516
|
|
6,473
|
|
5,373
|
|
Total
revenues
|
300,091
|
|
227,936
|
|
1,116,854
|
|
889,895
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
Cost of
sales
|
64,147
|
|
48,044
|
|
209,620
|
|
152,008
|
|
Research and
development
|
175,242
|
|
176,118
|
|
661,905
|
|
634,806
|
|
Selling, general and
administrative
|
142,958
|
|
113,907
|
|
476,593
|
|
402,271
|
|
Intangible asset
amortization and contingent consideration
|
7,365
|
|
(40,654)
|
|
(26,953)
|
|
(17,690)
|
|
Impairment of
intangible assets
|
—
|
|
198,700
|
|
599,118
|
|
198,700
|
|
Gain on sale of
intangible asset
|
—
|
|
(369,498)
|
|
—
|
|
(369,498)
|
|
Total operating
expenses
|
389,712
|
|
126,617
|
|
1,920,283
|
|
1,000,597
|
|
NET INCOME (LOSS)
FROM OPERATIONS
|
(89,621)
|
|
101,319
|
|
(803,429)
|
|
(110,702)
|
|
Equity in the loss of
BioMarin/Genzyme LLC
|
(164)
|
|
(278)
|
|
(538)
|
|
(817)
|
|
Interest
income
|
2,926
|
|
1,451
|
|
7,487
|
|
4,501
|
|
Interest
expense
|
(9,732)
|
|
(9,333)
|
|
(39,499)
|
|
(38,244)
|
|
Other income
(expense)
|
4,425
|
|
(194)
|
|
4,929
|
|
(9,462)
|
|
NET INCOME (LOSS)
BEFORE INCOME TAXES
|
(92,166)
|
|
92,965
|
|
(831,050)
|
|
(154,724)
|
|
Provision for
(benefit from) income taxes
|
(1,446)
|
|
24,348
|
|
(200,840)
|
|
17,075
|
|
NET INCOME
(LOSS)
|
$ (90,720)
|
|
$
68,617
|
|
$
(630,210)
|
|
$(171,799)
|
|
NET INCOME (LOSS)
PER SHARE, BASIC
|
$
(0.53)
|
|
$
0.43
|
|
$
(3.80)
|
|
$
(1.07)
|
|
NET INCOME (LOSS)
PER SHARE, DILUTIVE
|
$
(0.53)
|
|
$
0.39
|
|
$
(3.81)
|
|
$
(1.07)
|
|
Weighted average
common shares outstanding, basic
|
172,006
|
|
161,149
|
|
165,985
|
|
160,025
|
|
Weighted average
common shares outstanding, diluted
|
172,240
|
|
174,288
|
|
166,219
|
|
160,025
|
Non-GAAP Information
The results presented in this press release for the three and
twelve months ended December 31, 2016
and 2015 as well as 2017 full-year guidance 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 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 Other income (expense) 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
Income (Loss) to non-GAAP Income (Loss):
|
Reconciliation of
GAAP Net Income (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,
2017
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Guidance
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net
Loss
|
$
(91.0)
|
|
$
69.0
|
|
$
(630.0)
|
|
$
(172.0)
|
|
$(180) -
$(140)
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
7.0
|
|
8.0
|
|
32.0
|
|
34.0
|
|
35
|
|
Provision for (benefit from) income taxes
|
(1.0)
|
|
24.0
|
|
(201.0)
|
|
17.0
|
|
(60) -
(100)
|
|
Depreciation expense
|
14.0
|
|
10.0
|
|
56.0
|
|
35.0
|
|
45 -
55
|
|
Amortization expense
|
7.0
|
|
3.0
|
|
30.0
|
|
11.0
|
|
30
|
|
Stock-based compensation expense
|
37.0
|
|
30.0
|
|
135.0
|
|
111.0
|
|
135 -
155
|
|
Contingent consideration expense (1)
|
—
|
|
(44.0)
|
|
(57.0)
|
|
(29.0)
|
|
25 -
35
|
|
Acquisition expenses(2)
|
—
|
|
—
|
|
—
|
|
7.0
|
|
-
|
|
Impairment charges(3)
|
—
|
|
199.0
|
|
599.0
|
|
212.0
|
|
-
|
|
Gain on
sale of intangible asset(4)
|
—
|
|
(369.0)
|
|
—
|
|
(369.0)
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
non-GAAP Income
(Loss)
|
$ (27.0)
|
|
$ (70.0)
|
|
$
(36.0)
|
|
$ (143.0)
|
|
$30 -
$70
|
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
|
|
Three and Twelve
Months Ended December 31, 2016 and 2015
|
|
(In millions of
U.S. dollars)
|
|
(Unaudited)
|
|
|
Three Months Ended
December 31,
|
|
2016
|
|
2015
|
|
|
|
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
|
$
64.0
|
|
$
—
|
|
$
(3.0)
|
|
$
61.0
|
|
$
48.0
|
|
$
—
|
|
$
(2.0)
|
|
$
46.0
|
|
Research and
development
|
175.0
|
|
(8.0)
|
|
(15.0)
|
|
152.0
|
|
176.0
|
|
(4.0)
|
|
(14.0)
|
|
158.0
|
|
Selling, general
and administrative
|
143.0
|
|
(6.0)
|
|
(19.0)
|
|
118.0
|
|
114.0
|
|
(6.0)
|
|
(14.0)
|
|
94.0
|
|
Intangible asset
amortization and contingent consideration (1)
|
7.0
|
|
(7.0)
|
|
—
|
|
—
|
|
(41.0)
|
|
(3.0)
|
|
44.0
|
|
—
|
|
Impairment of
intangible assets(3)
|
—
|
|
—
|
|
—
|
|
—
|
|
199.0
|
|
—
|
|
(199.0)
|
|
—
|
|
Gain on sale of
intangible asset (4)
|
—
|
|
—
|
|
—
|
|
—
|
|
(369.0)
|
|
—
|
|
369.0
|
|
—
|
|
Interest expense,
net
|
(7.0)
|
|
7.0
|
|
—
|
|
—
|
|
(8.0)
|
|
8.0
|
|
—
|
|
—
|
|
Other income
(expense)
|
4.0
|
|
—
|
|
—
|
|
4.0
|
|
—
|
|
—
|
|
—
|
|
—
|
|
Provision for
(benefit from) income taxes
|
(1.0)
|
|
1.0
|
|
—
|
|
—
|
|
24.0
|
|
(24.0)
|
|
—
|
|
—
|
|
Net Income
(Loss)/non-GAAP Loss
|
(91.0)
|
|
27.0
|
|
37.0
|
|
(27.0)
|
|
69.0
|
|
45.0
|
|
(184.0)
|
|
(70.0)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months
Ended December 31,
|
|
2016
|
|
2015
|
|
|
|
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
|
$
210.0
|
|
$
—
|
|
$
(9.0)
|
|
$
201.0
|
|
$
152.0
|
|
$
—
|
|
$
(7.0)
|
|
$
145.0
|
|
Research and
development
|
662.0
|
|
(31.0)
|
|
(58.0)
|
|
573.0
|
|
635.0
|
|
(16.0)
|
|
(49.0)
|
|
570.0
|
|
Selling, general and
administrative(2)
|
477.0
|
|
(25.0)
|
|
(68.0)
|
|
384.0
|
|
402.0
|
|
(19.0)
|
|
(62.0)
|
|
321.0
|
|
Intangible asset
amortization and contingent consideration (1)
|
(27.0)
|
|
(30.0)
|
|
57.0
|
|
—
|
|
(18.0)
|
|
(11.0)
|
|
29.0
|
|
—
|
|
Impairment of
intangible assets(3)
|
599.0
|
|
—
|
|
(599.0)
|
|
—
|
|
199.0
|
|
—
|
|
(199.0)
|
|
—
|
|
Gain on sale of
intangible asset (4)
|
—
|
|
—
|
|
—
|
|
—
|
|
(369.0)
|
|
—
|
|
369.0
|
|
—
|
|
Interest expense,
net
|
(32.0)
|
|
32.0
|
|
—
|
|
—
|
|
(34.0)
|
|
34.0
|
|
—
|
|
—
|
|
Other income
(expense)
|
(4.0)
|
|
—
|
|
—
|
|
(4.0)
|
|
(10.0)
|
|
—
|
|
13.0
|
|
3.0
|
|
Provision for
(benefit from) income taxes
|
(201.0)
|
|
201.0
|
|
—
|
|
—
|
|
17.0
|
|
(17.0)
|
|
—
|
|
—
|
|
Net Loss/non-GAAP
Loss
|
(630.0)
|
|
(83.0)
|
|
677.0
|
|
(36.0)
|
|
(172.0)
|
|
97.0
|
|
(68.0)
|
|
(143.0)
|
|
|
|
(1)
|
Includes 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 $44 million and $21 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)
|
Includes $7 million
of acquisition costs for the year ended December 31, 2015 related
to the acquisition of Prosensa Holdings N.V.
|
|
|
|
(3)
|
Includes $574 million
and $25 million for the impairment of intangible assets associated
with the discontinuance of the Kyndrisa and reveglucosidase alfa
development programs, respectively, in June 2016. The $199 million
in the three and twelve months ended December 31, 2015, primarily
represents the impairment of a portion of the Kyndrisa in-process
research and development (IPR&D) intangible assets.
|
|
|
|
(4)
|
The $369 million gain
in the three and twelve months ended December 31, 2015, represents
the net gain on the sale of the Company's world-wide rights to
talazoparib to Medivation Inc.
|
|
Contact:
|
|
|
|
Investors:
|
|
Media:
|
|
Traci
McCarty
|
|
Debra
Charlesworth
|
|
BioMarin
Pharmaceutical Inc.
|
|
BioMarin
Pharmaceutical Inc.
|
|
(415)
455-7558
|
|
(415)
455-7451
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/biomarin-announces-fourth-quarter-and-full-year-2016-financial-results-300412319.html
SOURCE BioMarin Pharmaceutical Inc.