SAN RAFAEL, Calif.,
April 25, 2019 /PRNewswire/ --
Financial
Highlights (in millions of U.S. dollars, except per share data,
unaudited)
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Three Months Ended
March 31,
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2019
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2018
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%
Change
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Total
Revenues
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$
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400.7
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$
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373.4
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7%
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Net Product Revenues
Marketed by BioMarin(1)
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349.2
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303.0
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15%
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Vimizim Net Product
Revenues
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125.8
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117.1
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7%
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Kuvan Net Product
Revenues
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106.9
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99.1
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8%
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Naglazyme Net Product
Revenues
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86.9
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75.0
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16%
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Palynziq Net Product
Revenues
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12.3
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—
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n/a
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Brineura Net Product
Revenues
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12.2
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6.9
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77%
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Aldurazyme Net
Product Revenues
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45.3
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66.1
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(31)%
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GAAP Net
Loss
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$
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(56.5)
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$
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(44.1)
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GAAP Net Loss per
Share – Basic
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$
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(0.32)
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$
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(0.25)
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GAAP Net Loss per
Share – Diluted
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$
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(0.32)
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$
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(0.26)
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Non-GAAP Income
(2)
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$
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24.8
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$
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21.3
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March
31,
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December 31,
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2019
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2018
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Cash, cash
equivalents and investments
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$
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1,214.9
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$
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1,320.2
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(1)
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Net Product Revenues
Marketed by BioMarin is the sum of revenues from Vimizim, Kuvan,
Naglazyme, Palynziq, Brineura and Firdapse, each calculated in
accordance with Generally Accepted Accounting Principles in the
United States (U.S. GAAP). Genzyme Corporation (Genzyme) is
BioMarin's sole customer for Aldurazyme and is responsible for
marketing and selling Aldurazyme to third-parties. Refer page 8 for
a table showing Net Product Revenues by product, including
Firdapse.
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(2)
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Non-GAAP Income is
defined by the Company as reported GAAP Net Income, 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 8 of this press release for a
complete discussion of the Company's Non-GAAP financial information
and reconciliations to the comparable information reported under
U.S. GAAP.
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BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the
Company) today announced financial results for the first quarter
ended March 31, 2019.
Total Net Product Revenues for the first quarter 2019 increased
to $394.5 million, compared to
$369.1 million for the first quarter
of 2018. Net Product Revenues Marketed by BioMarin increased to
$349.2 million, compared to
$303.0 million for the first quarter
of 2018. The increase in Net Product Revenues Marketed by BioMarin
was attributed to the following:
- Vimizim: increased $8.7 million,
or 7%, primarily driven by government ordering patterns in certain
Latin American, Middle Eastern and European countries. Patient
growth in the quarter was robust with net patients growth
increasing 12% year over year;
- Kuvan: increased $7.8 million, or
8%, primarily due to new patients initiating therapy in the U.S.
and sales volume in Europe;
- Naglazyme: increased $11.9
million, or 16%, primarily due to increased sales volume
driven by government ordering patterns from Brazil;
- 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 during the first quarter of 2019
totaled $12.3 million driven
primarily by the conversion of clinical patients to commercial
Palynziq in the U.S.; and,
- Brineura: increased $5.3 million,
or 77%, primarily attributed to new patients initiating therapy in
Germany and the U.S.
Aldurazyme Net Product Revenues decreased $20.8 million, or 31%, due to timing of shipments
to Genzyme. Under the new revenue standards adopted in 2018,
the Company records Aldurazyme Net Product Revenues when the
product is released and control is transferred to Genzyme based on
the estimated variable consideration payable it expects to earn
when the product is sold through by Genzyme. Aldurazyme net product
sales reported by Genzyme increased to $75.7
million, or up 20% in the first quarter of 2019, compared to
$62.9 million the same period in
2018.
The increase in GAAP Net Loss for the first quarter of 2019,
compared to the same period in 2018 was primarily due to the
following:
- higher selling, general and administrative (SG&A) expense
in support of continued U.S. commercial launch of Palynziq and
European Union (EU) pre-launch activities, other administrative
expenses, consulting fees and employee-related costs to support our
operations;
- increased contingent consideration expense related to the
progression of the Palynziq development program towards approval of
the European Marketing Authorization Application, as a result of
the positive opinion from the Committee for Medicinal Products for
Human Use (CHMP) in the first quarter; partially offset by,
- increased gross profits of $20.4
million driven by increased sales revenue from products
marketed by BioMarin.
Non-GAAP Income for the first quarter of 2019 increased
$3.5 million, or 16%, to $24.8 million, compared to $21.3 million for the same period in 2018. The
increase in Non-GAAP Income for the quarter was attributed to
increased gross profit from sales partially offset by higher
SG&A expenses as described above.
As of March 31, 2019, BioMarin had
cash, cash equivalents and investments totaling approximately
$1.2 billion, as compared to
$1.3 billion on December 31, 2018.
Commenting on first quarter results, Jean-Jacques Bienaimé,
Chairman and Chief Executive Officer of BioMarin, said, "We begin
2019 well-positioned for potential significant achievements across
our late-stage product pipeline, as well as record Total Revenues
for the full year. Starting with valoctocogene roxaparvovec gene
therapy for severe hemophilia A, our pivotal study is on track to
complete enrollment in the third quarter. Based on draft guidance
from the FDA for hemophilia gene therapy products published in
2018, we have the opportunity to pursue a potential accelerated
approval path forward based on Factor VIII activity results from a
subset of Phase 3 subjects. Based on the results from the
subset of Phase 3 subjects, we will make and communicate our
decision on whether or not to pursue an accelerated approval before
the end of the year. We have observed a high level of interest and
enthusiasm from the hemophilia community in support of
valoctocogene roxaparvovec and are hopeful that it will be a
potential treatment option for these patients in the very near
future."
Mr. Bienaimé continued, "We have a number of other exciting
catalysts on the horizon including the potential approval and
launch of Palynziq in Europe later
this year. We have been thrilled with the pace of the U.S.
launch, as we ended the first quarter with 414 patients on
reimbursed Palynziq. Building on this success and as part of our
strategy to increase our leadership in the PKU market, we
anticipate filing an IND for BMN 307, our gene therapy product for
PKU, in the second half of 2019. BMN 307 demonstrated lifetime
normalization of Phe in a validated PKU mouse model, and as a
result we believe it has the potential to be an important new
treatment and market expander as part of our PKU franchise.
Finally, we look forward with great anticipation to the results of
our global Phase 3 program with vosoritide for the treatment of
achondroplasia. Our ongoing Phase 2 study has so far demonstrated
an average additional cumulative height gain of 5.7 centimeters
over 42 months. Based on data observed to date, we are very
encouraged that vosoritide could potentially be the first approved
treatment option for children with achondroplasia."
2019 Full-Year Financial Guidance unchanged (in millions,
except %)
Item
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2019
Guidance
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Total
Revenues
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$1,680
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to
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$1,750
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Vimizim Net Product
Revenues
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$530
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to
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$570
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Kuvan Net Product
Revenues
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$420
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to
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$460
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Naglazyme Net Product
Revenues
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$350
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to
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$380
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Palynziq Net Product
Revenues
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|
$70
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to
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$100
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Brineura Net Product
Revenues
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$55
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to
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$75
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|
|
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|
Cost of Sales (% of
Total Revenues)
|
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20%
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to
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21%
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Research and
Development Expense
|
|
$740
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to
|
$780
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|
Selling, General and
Admin. Expense
|
|
$650
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to
|
$690
|
|
|
|
|
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GAAP Net
Loss
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$(45)
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to
|
$(85)
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Non-GAAP Income
*
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$130
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to
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$170
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*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 8 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
- Valoctocogene roxaparvovec gene therapy for hemophilia
A: During the quarter, the Company announced that it had
enrolled the subset of subjects from the ongoing Phase 3 study that
could potentially be used to support submission of a marketing
application through the accelerated approval pathway. In addition,
BioMarin has completed the process qualification manufacturing
campaigns required as part of a BLA submission for accelerated
approval. The Company intends to make a decision on whether or not
to pursue a potential accelerated approval path and communicate
that decision before the end of 2019.
In 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 complete Phase 3 GENEr8-1
study will include 130 participants, and is expected to be fully
enrolled in the third quarter of 2019.
- Palynziq for PKU: Palynziq, an injection to reduce blood
Phe concentrations in adult patients with PKU, was added to
BioMarin's commercial product portfolio upon its U.S. approval last
May. As of March 31, 2019, 414
patients were on reimbursed Palynziq, with an additional 140
patients enrolled and awaiting their first treatment with
commercial Palynziq. Of the 414 patients on therapy at the end of
the first quarter, 278 were formerly naïve patients and 136
transitioned from clinical studies. Of the 125 PKU clinics in the
U.S., 89 had at least one complete patient enrollment in the REMS
program as of March 31, 2019.
BioMarin received a positive opinion from the Committee for
Medicinal Products for Human Use (CHMP), the scientific committee
of the European Medicines Agency (EMA), on Palynziq on March 1, 2019. Based on this positive opinion,
the Company anticipates marketing authorization in the European
Union by the end of the second quarter of this year.
- Vosoritide for children with achondroplasia: The Company
expects top line results from the ongoing global, Phase 3 study by
year-end 2019. 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. The
Company most recently updated its ongoing global Phase 2 study in
children ages 5 to 14, which 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
anticipated marketing authorization submissions.
In 2018, BioMarin began a global Phase 2 study with vosoritide in
infants and young children (less than 60 months old) with
achondroplasia, to determine the impact of treatment in this age
group. Three cohorts, segmented by age, are being enrolled in this
study. Cohort 1 includes children ages 24 to 60 months old and will
complete enrollment this year. Cohort 2 includes children ages 6 to
24 months old and is currently enrolling. Following evaluation of
safety and pharmacokinetics in sentinel subjects in cohort 2,
cohort 3 will begin enrolling infants up to 6 months
old.
- Tralesinidase alfa (formerly referred to as BMN 250) for MPS
IIIB (Sanfilippo Syndrome, Type B): Tralesinidase alfa is
currently being evaluated in ongoing natural history and clinical
trials. Previously, encouraging signs of biochemical and clinical
efficacy have been suggested. Trials are ongoing to collect further
data in regard to the untreated natural history of the condition,
as well as biochemical and clinical outcomes of therapy.
- BMN 307 gene therapy product candidate for phenylketonuria
(PKU): As previously announced, 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. Product to support clinical evaluation will be produced at
BioMarin's Leveroni facility using a commercial scale manufacturing
process to facilitate rapid clinical development.
- 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
first quarter 2019 financial results today, Thursday, April 25, 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
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Conference ID:
9996637
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Conference ID:
9996637
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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 commercial products
and multiple clinical and pre-clinical product candidates for the
treatment of various diseases. 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 and other
specified income statement guidance; the financial performance of
BioMarin as a whole; BioMarin's potential for growth: BioMarin
being well-position for significant achievements across its
late-stage product pipeline, as well as record Total Revenues for
the full year; 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; 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 the communication of
that decision; (iii) statements regarding BioMarin's encouragement
that vosoritide could potentially be the first approved treatment
option for children with achondroplasia; and (iv) 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 Annual Report on Form 10-K for the year
ended December 31, 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.
Contact:
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|
|
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
|
March 31, 2019 and
December 31, 2018
|
(In thousands of
U.S. dollars, except share and per share amounts)
|
|
|
|
March 31, 2019
(1)
|
|
|
December 31,
2018 (2)
|
|
ASSETS
|
|
(unaudited)
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
364,369
|
|
|
$
|
493,982
|
|
Short-term
investments
|
|
|
530,485
|
|
|
|
590,326
|
|
Accounts receivable,
net
|
|
|
393,429
|
|
|
|
342,633
|
|
Inventory
|
|
|
534,696
|
|
|
|
530,871
|
|
Other current
assets
|
|
|
93,876
|
|
|
|
98,403
|
|
Total current
assets
|
|
|
1,916,855
|
|
|
|
2,056,215
|
|
Noncurrent
assets:
|
|
|
|
|
|
|
|
|
Long-term
investments
|
|
|
320,000
|
|
|
|
235,864
|
|
Property, plant and
equipment, net
|
|
|
951,890
|
|
|
|
948,682
|
|
Intangible assets,
net
|
|
|
485,981
|
|
|
|
491,808
|
|
Goodwill
|
|
|
197,039
|
|
|
|
197,039
|
|
Deferred tax
assets
|
|
|
467,333
|
|
|
|
460,952
|
|
Other
assets
|
|
|
96,300
|
|
|
|
36,568
|
|
Total
assets
|
|
$
|
4,435,398
|
|
|
$
|
4,427,128
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities
|
|
$
|
412,830
|
|
|
$
|
437,290
|
|
Short-term contingent
consideration
|
|
|
88,156
|
|
|
|
85,951
|
|
Total current
liabilities
|
|
|
500,986
|
|
|
|
523,241
|
|
Noncurrent
liabilities:
|
|
|
|
|
|
|
|
|
Long-term convertible
debt, net
|
|
|
834,766
|
|
|
|
830,417
|
|
Long-term contingent
consideration
|
|
|
48,461
|
|
|
|
46,883
|
|
Other long-term
liabilities
|
|
|
114,558
|
|
|
|
58,647
|
|
Total
liabilities
|
|
|
1,498,771
|
|
|
|
1,459,188
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
|
Common stock, $0.001
par value: 500,000,000 shares authorized; 179,033,104 and 178,252,954 shares issued and
outstanding, respectively.
|
|
|
179
|
|
|
|
178
|
|
Additional paid-in
capital
|
|
|
4,682,900
|
|
|
|
4,669,926
|
|
Company common stock
held by Nonqualified Deferred Compensation Plan
|
|
|
(12,912)
|
|
|
|
(13,301)
|
|
Accumulated other
comprehensive income
|
|
|
19,794
|
|
|
|
5,271
|
|
Accumulated
deficit
|
|
|
(1,753,334)
|
|
|
|
(1,694,134)
|
|
Total
stockholders' equity
|
|
|
2,936,627
|
|
|
|
2,967,940
|
|
Total liabilities and
stockholders' equity
|
|
$
|
4,435,398
|
|
|
$
|
4,427,128
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
As of January 1,
2019, the Company adopted the requirements of Accounting Standards
Codification 842, Leases, using the modified retrospective
method as of the effective date, and as a result, Other Assets and
Liabilities are not comparable to the prior periods
presented.
|
|
|
(2)
|
December 31, 2018
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, 2018, filed with the U.S. Securities
and Exchange Commission (SEC) on February 28, 2018.
|
BIOMARIN
PHARMACEUTICAL INC.
|
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
Three Months Ended
March 31, 2019 and 2018
|
(In thousands of
U.S. dollars, except per share amounts)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
2019
|
|
|
2018
|
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
Net product
revenues
|
|
$
|
394,483
|
|
|
$
|
369,099
|
|
|
Royalty and other
revenues
|
|
|
6,262
|
|
|
|
4,348
|
|
|
Total net
revenues
|
|
|
400,745
|
|
|
|
373,447
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
|
|
Cost of
sales
|
|
|
89,182
|
|
|
|
82,333
|
|
|
Research and
development
|
|
|
183,591
|
|
|
|
183,948
|
|
|
Selling, general and
administrative
|
|
|
162,158
|
|
|
|
138,336
|
|
|
Intangible asset
amortization and contingent consideration
|
|
|
19,765
|
|
|
|
13,202
|
|
|
Total operating
expenses
|
|
|
454,696
|
|
|
|
417,819
|
|
|
LOSS FROM
OPERATIONS
|
|
|
(53,951)
|
|
|
|
(44,372)
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in the income
(loss) of BioMarin/Genzyme LLC
|
|
|
(185)
|
|
|
|
68
|
|
|
Interest
income
|
|
|
6,298
|
|
|
|
5,234
|
|
|
Interest
expense
|
|
|
(6,727)
|
|
|
|
(11,562)
|
|
|
Other income
(expense), net
|
|
|
1,608
|
|
|
|
(172)
|
|
|
LOSS BEFORE INCOME
TAXES
|
|
|
(52,957)
|
|
|
|
(50,804)
|
|
|
Provision for
(benefit from) income taxes
|
|
|
3,516
|
|
|
|
(6,655)
|
|
|
NET
LOSS
|
|
$
|
(56,473)
|
|
|
$
|
(44,149)
|
|
|
NET LOSS PER
SHARE, BASIC
|
|
$
|
(0.32)
|
|
|
$
|
(0.25)
|
|
|
NET LOSS PER
SHARE, DILUTED
|
|
$
|
(0.32)
|
|
|
$
|
(0.26)
|
|
|
Weighted average
common shares outstanding, basic
|
|
|
178,271
|
|
|
|
175,932
|
|
|
Weighted average
common shares outstanding, diluted
|
|
|
178,271
|
|
|
|
176,150
|
|
|
The following table presents the Net Product Revenues by
Product:
Net Product
Revenues By Product
|
(In millions of
U.S. dollars)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
March
31,
|
|
|
2019
|
|
|
2018
|
|
Brineura
|
$
|
12.2
|
|
|
$
|
6.9
|
|
Firdapse
|
5.1
|
|
|
|
4.9
|
|
Kuvan
|
106.9
|
|
|
|
99.1
|
|
Naglazyme
|
86.9
|
|
|
|
75.0
|
|
Palynziq
|
12.3
|
|
|
|
—
|
|
Vimizim
|
125.8
|
|
|
|
117.1
|
|
Net Product Revenues
Marketed by BioMarin
|
349.2
|
|
|
|
303.0
|
|
Aldurazyme Net
Product Revenues Marketed by Genzyme
|
|
45.3
|
|
|
|
66.1
|
|
Total Net Product
Revenues
|
$
|
394.5
|
|
|
$
|
369.1
|
|
|
|
|
|
|
|
|
|
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 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 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 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 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 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:
Reconciliation of
GAAP Net Loss to Non-GAAP Income
|
(In millions of
U.S. dollars)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
Guidance
|
|
|
March
31,
|
|
|
|
Year
Ending
|
|
|
2019
|
|
|
2018
|
|
|
|
December 31,
2019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net
Loss
|
$
|
(56.5)
|
|
|
$
|
(44.1)
|
|
|
|
$
|
(45.0)
|
|
−
|
$
|
(85.0)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
0.4
|
|
|
|
6.3
|
|
|
|
|
—
|
|
−
|
|
10.0
|
|
Provision for (Benefit from) income taxes
|
|
3.5
|
|
|
|
(6.7)
|
|
|
|
|
(50.0)
|
|
−
|
|
(30.0)
|
|
Depreciation expense
|
|
14.9
|
|
|
|
16.0
|
|
|
|
|
45.0
|
|
−
|
|
60.0
|
|
Amortization expense
|
|
7.5
|
|
|
|
7.6
|
|
|
|
|
40.0
|
|
−
|
|
55.0
|
|
Stock-based compensation expense
|
|
42.7
|
|
|
|
36.6
|
|
|
|
|
150.0
|
|
−
|
|
175.0
|
|
Contingent consideration expense
|
|
12.3
|
|
|
|
5.6
|
|
|
|
|
20.0
|
|
−
|
|
30.0
|
|
Gain on
sale of intangible assets
|
|
—
|
|
|
|
—
|
|
|
|
|
(30.0)
|
|
−
|
|
(45.0)
|
|
Non-GAAP
Income
|
$
|
24.8
|
|
|
$
|
21.3
|
|
|
|
$
|
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
March 31,
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
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
|
$
|
89.2
|
|
|
$
|
—
|
|
|
$
|
(4.8)
|
|
|
$
|
84.4
|
|
|
$
|
82.3
|
|
|
$
|
—
|
|
|
$
|
(3.1)
|
|
|
$
|
79.2
|
|
Research and
development
|
|
183.6
|
|
|
|
(9.3)
|
|
|
|
(13.8)
|
|
|
|
160.5
|
|
|
|
183.9
|
|
|
|
(10.5)
|
|
|
|
(13.3)
|
|
|
|
160.1
|
|
Selling, general and
administrative
|
|
162.2
|
|
|
|
(5.6)
|
|
|
|
(24.1)
|
|
|
|
132.5
|
|
|
|
138.3
|
|
|
|
(5.5)
|
|
|
|
(20.2)
|
|
|
|
112.6
|
|
Intangible asset
amortization and contingent
consideration
|
|
19.8
|
|
|
|
(7.5)
|
|
|
|
(12.3)
|
|
|
|
—
|
|
|
|
13.2
|
|
|
|
(7.6)
|
|
|
|
(5.6)
|
|
|
|
—
|
|
Interest expense,
net
|
|
(0.4)
|
|
|
|
0.4
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(6.3)
|
|
|
|
6.3
|
|
|
|
—
|
|
|
|
—
|
|
Provision for
(Benefit from) income taxes
|
|
3.5
|
|
|
|
(3.5)
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(6.7)
|
|
|
|
6.7
|
|
|
|
—
|
|
|
|
—
|
|
GAAP Net
Loss/Non-GAAP Income
|
|
(56.5)
|
|
|
|
26.3
|
|
|
$
|
55.0
|
|
|
|
24.8
|
|
|
|
(44.1)
|
|
|
|
23.2
|
|
|
|
42.2
|
|
|
|
21.3
|
|
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SOURCE BioMarin Pharmaceutical Inc.