-First Quarter 2016 Total BioMarin Revenue
Increases 16.7% Y/Y to $236.7 million
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) today announced
financial results for the first quarter ended March 31, 2016.
Non-GAAP net loss was $27.2 million for the quarter ended March 31,
2016, compared to non-GAAP net loss of $25.4 million for the first
quarter of 2015. GAAP net loss was $85.1 million, or $0.53 per
basic and diluted share for the first quarter of 2016, compared to
GAAP net loss of $67.5 million, or $0.43 per basic and diluted
share, for the first quarter of 2015.
Total BioMarin Revenue was $236.7 million for
the first quarter of 2016, an increase of 16.7% compared to the
same period in 2015. This strong result was driven by year
over year growth of 43.5% and 53.2% of Vimizim and Kuvan,
respectively. Kuvan revenue from ex-North America territories
since BioMarin acquired worldwide rights in January 2016
contributed $16.9 million and revenues in North America contributed
$60.0 million in the quarter. Naglazyme patient growth was
8.5% compared to a year ago, the 40th straight quarter since the
product was launched in 2005. Naglazyme revenue in the first
quarter 2016 was lower than revenue in the first quarter 2015
primarily due to the timing of central government orders from Latin
America.
As of March 31, 2016, BioMarin had cash, cash
equivalents and investments totaling $771.3 million, as compared to
$1,018.3 million on December 31, 2015.
Commenting on the quarter, Jean-Jacques
Bienaimé, Chairman and Chief Executive Officer of BioMarin said,
“Our commercial base business is robust and is expected to generate
over one billion dollars in revenues this year. Prospects for
new product launches in 2017 increased during the quarter due to
positive data readouts for cerliponase alfa and pegvaliase that we
expect will lead to two new product filings later this year.
In addition, at our recent Research and Development Day for
analysts and investors, we highlighted very encouraging preliminary
data from our gene therapy product BMN 270 for hemophilia A and
robust 12 month data with vosoritide for achondroplasia. If
the data from these programs continue to mature as we hope, we
believe that these products could each ultimately drive a billion
dollars in revenue when commercialized. Finally, we continue
to expect to manage this growing business with the goal of
achieving non-GAAP break-even or better in 2017 regardless of the
regulatory outcome of Kyndrisa in Europe.”
Net Product Revenue (in millions of U.S.
dollars, unaudited)
Total Revenue
|
|
Three Months Ended March 31, |
|
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vimizim (1) |
|
$ |
72.6 |
|
|
$ |
50.6 |
|
|
$ |
22.0 |
|
|
|
43.5 |
% |
Naglazyme (1) |
|
|
65.4 |
|
|
|
78.2 |
|
|
|
(12.8 |
) |
|
|
(16.4 |
)% |
Kuvan (2) |
|
|
76.9 |
|
|
|
50.2 |
|
|
|
26.7 |
|
|
|
53.2 |
% |
Aldurazyme |
|
|
16.4 |
|
|
|
18.2 |
|
|
|
(1.8 |
) |
|
|
(9.9 |
)% |
Firdapse |
|
|
4.1 |
|
|
|
4.1 |
|
|
|
- |
|
|
|
0.0 |
% |
Net product revenues |
|
|
235.4 |
|
|
|
201.3 |
|
|
|
34.1 |
|
|
|
16.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative agreement
revenues |
|
|
0.2 |
|
|
|
0.4 |
|
|
|
(0.2 |
) |
|
|
|
|
Royalty, license and
other revenues |
|
|
1.1 |
|
|
|
1.2 |
|
|
|
(0.1 |
) |
|
|
|
|
Total BioMarin revenues |
|
$ |
236.7 |
|
|
$ |
202.9 |
|
|
$ |
33.8 |
|
|
|
16.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Vimizim and Naglazyme revenues experience
quarterly fluctuations primarily due to the timing of government
ordering patterns in certain countries. The Company does not
believe these fluctuations reflect a change in underlying
demand.(2) Growth in North America contributed $60.0 million in the
first quarter with an additional $16.9 million coming from newly
acquired ex-North American territories.
Reconciliation of Aldurazyme
Revenues
|
|
Three Months Ended March 31, |
|
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
|
% Change |
|
Aldurazyme revenue
reported by Genzyme |
|
$ |
52.8 |
|
|
$ |
53.4 |
|
|
$ |
(0.6 |
) |
|
|
(1.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
Royalties earned from
Genzyme |
|
$ |
21.5 |
|
|
$ |
22.3 |
|
|
$ |
(0.8 |
) |
Net product transfer
revenues (3) |
|
|
(5.1 |
) |
|
|
(4.1 |
) |
|
|
(1.0 |
) |
Total Aldurazyme net product
revenues |
|
$ |
16.4 |
|
|
$ |
18.2 |
|
|
$ |
(1.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) To the extent units shipped to third party
customers by Genzyme exceed BioMarin inventory transfers to
Genzyme, BioMarin will record a decrease in net product revenue
from the royalty 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 revenue 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.
2016 Financial Guidance
Revenue Guidance ($ in millions)
Item |
|
|
|
|
|
|
ProvidedFebruary 25, 2016 |
|
Updated April
28, 2016 |
Total BioMarin Revenues |
|
$1,050 to $1,100 |
|
Unchanged |
Vimizim Net Product Revenue |
|
$300 to $330 |
|
$315 to $340 |
Naglazyme Net Product Revenue |
|
$290 to $320 |
|
Unchanged |
Kuvan Net Product Revenue |
|
$320 to $350 |
|
Unchanged |
|
|
|
|
|
Select Income Statement Guidance ($ in millions,
except percentages)
Item |
|
|
|
|
|
|
ProvidedFebruary 25, 2016 |
|
Updated April
28, 2016 |
Cost of Sales (% of Total Revenue) |
|
18.0% to 19.0% |
|
Unchanged |
Selling, General and Admin. Expense |
|
$470 to $490 |
|
Unchanged |
Research and Development Expense |
|
$680 to $720 |
|
Unchanged |
Non - GAAP Net Loss |
|
$(75) to $(100) |
|
Unchanged |
GAAP Net Loss |
|
$(400) to $(430) |
|
$(355) to $(385)* |
|
|
|
|
|
*GAAP Net Loss guidance updated April 28, 2016
based on impact of final purchase accounting treatment for the PKU
franchise acquisition from Merck that closed in the first quarter
2016.
Key Program Updates at R&D Day April
20, 2016
- BMN 270 gene therapy product for hemophilia
A: The Company provided encouraging preliminary data
from an ongoing Phase 1/2 clinical trial with BMN 270, an
investigational gene therapy treatment for hemophilia A. A
total of eight patients with severe hemophilia A received a single
dose of BMN 270, six of whom have been treated at the highest dose
of 6 x 1013 vector genomes (VG)/kilogram (kg), and to date,
post-treatment follow-up ranges from five to 16 weeks. As
stated at R&D Day, patients at the highest dose experienced
increasing Factor VIII activity levels ranging between 4% and 60%
(as a percentage of normal calculated based on the numbers of
International Units (IU) per milliliter of whole blood), with five
of six patients treated at the high dose now over 5% and two of six
at over 50%. All high dose patients improved from severe to
either moderate, mild or normal range in terms of factor levels
based on World Federation of Hemophilia criteria. (See BioMarin
press release from April 20, 2016 for further details.)
- Vosoritide for achondroplasia: The
Company provided an update on its Phase 2 study of vosoritide, an
analog of C-type Natriuretic Peptide (CNP), in children with
achondroplasia, the most common form of dwarfism. After 12
months of daily dosing at 15 µg/kg/day, the cohort 3 patients
(n=10) experienced a 46% or 1.9 cm/year increase in mean annualized
growth velocity from baseline (p-value = 0.02). These
findings provide evidence of durability of effect consistent with
previously presented 6-month data for these patients, which
demonstrated an annualized increase of 50% or 2.0 cm/year in mean
annualized growth velocity. In addition, 6-month data for 12
patients who were initiated on a lower dose and switched to 15
µg/kg/day showed an increase of 65% or 2.3 cm/year in mean
annualized growth velocity from baseline (p-value = 0.002).
(See BioMarin press release from April 20, 2016 for further
details.)
- Cerliponase alfa for CLN2, late-infantile form of
Batten disease: Complete results from the Phase 1/2
study of cerliponase alfa, a recombinant human tripeptidyl
peptidase 1 (rhTPP1), for the treatment of patients with
late-infantile neuronal ceroid lipofuscinosis type 2 (NCL-2), a
form of Batten disease were announced at the WORLD LSD Symposium on
March 2, 2016. Based on the robust data results announced at
that meeting, the Company shared plans to submit in the U.S. and
E.U. for regulatory approval mid-year 2016. (See BioMarin
press release from March 2, 2016 for further details.)
- Pegvaliase for phenylketonuria (PKU):
Pivotal results for the Phase 3 PRISM-2 study (formerly referred to
as 165-302) that pegvaliase met the primary endpoint of change in
blood Phe compared with placebo (p<0.0001) were announced March
21, 2016. The pegvaliase treated group maintained mean blood
Phe levels at 527.2 umol/L compared to their 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 Biologics License Application (BLA) to U.S. FDA
in the second half of 2016. (See BioMarin press release from March
21, 2016 for further details.)
Conference Call Details
BioMarin will host a conference call and webcast
to discuss first quarter 2016 financial results today, Thursday,
April 28, at 4:30 p.m. ET. This event can be accessed on the
investor section of the BioMarin website at www.BMRN.com.
U.S. / Canada Dial-in Number:
877.303.6313International Dial-in Number: 631.813.4734Conference
ID: 86095021
Replay Dial-in Number: 855.859.2056Replay
International Dial-in Number: 404.537.3406Conference ID:
86095021
About BioMarinBioMarin 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.BMRN.com.
Forward-Looking StatementThis
press release contains forward-looking statements about the
business prospects of BioMarin Pharmaceutical Inc., including,
without limitation, statements about: the expectations of revenue
and sales related to Vimizim, Naglazyme, Kuvan, Firdapse, and
Aldurazyme; the financial performance of the BioMarin as a whole;
the timing of BioMarin's clinical trials; the continued clinical
development and commercialization of Vimizim, Naglazyme, Kuvan,
Firdapse, Aldurazyme and its 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: our success in the
commercialization of Vimizim, Naglazyme, Kuvan, and Firdapse;
Genzyme Corporation's success in continuing the commercialization
of Aldurazyme; results and timing of current and planned
preclinical studies and clinical trials, our ability to
successfully manufacture our products and product candidates; the
content and timing of decisions by the U.S. Food and Drug
Administration, 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
Vimizim, Naglazyme, Kuvan, Firdapse and Aldurazyme; and those
factors detailed in BioMarin's filings with the Securities and
Exchange Commission, including, without limitation, the factors
contained under the caption "Risk Factors" in BioMarin's 2015
Annual Report on Form 10-K, and the factors contained in BioMarin's
reports on Form 10-Q. 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®, Naglazyme®, Kuvan®, Firdapse® and
Vimizim® are registered trademarks of BioMarin Pharmaceutical Inc.,
or its affiliates. KyndrisaTM is a trademark of BioMarin
Pharmaceutical Inc. Aldurazyme® is a registered trademark of
BioMarin/Genzyme LLC.
|
BIOMARIN PHARMACEUTICAL INC. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
March 31, 2016 and December 31,
2015 |
(In thousands of U.S. dollars, except share and
per share amounts) |
|
|
|
|
|
|
|
|
|
March 31, 2016 |
|
|
December 31, 2015(1) |
|
ASSETS |
|
(unaudited) |
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
270,453 |
|
|
$ |
397,040 |
|
Short-term investments |
|
|
186,400 |
|
|
|
195,579 |
|
Accounts receivable, net (allowance
for doubtful accounts: $167 and $93, at March 31, 2016 and
December 31, 2015, respectively) |
|
|
180,751 |
|
|
|
164,959 |
|
Inventory |
|
|
296,979 |
|
|
|
271,683 |
|
Other current assets |
|
|
58,207 |
|
|
|
60,378 |
|
Total current assets |
|
|
992,790 |
|
|
|
1,089,639 |
|
Noncurrent assets: |
|
|
|
|
|
|
|
|
Long-term investments |
|
|
314,404 |
|
|
|
425,652 |
|
Property, plant and equipment,
net |
|
|
716,916 |
|
|
|
704,207 |
|
Intangible assets, net |
|
|
1,177,232 |
|
|
|
683,996 |
|
Goodwill |
|
|
197,039 |
|
|
|
197,039 |
|
Long-term deferred tax assets |
|
|
243,212 |
|
|
|
220,191 |
|
Other assets |
|
|
25,400 |
|
|
|
408,644 |
|
Total assets |
|
$ |
3,666,993 |
|
|
$ |
3,729,368 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and
accrued liabilities |
|
|
290,562 |
|
|
|
392,511 |
|
Short-term contingent acquisition
consideration payable |
|
|
97,449 |
|
|
|
52,946 |
|
Total current liabilities |
|
|
388,011 |
|
|
|
445,457 |
|
Noncurrent liabilities: |
|
|
|
|
|
|
|
|
Long-term convertible
debt |
|
|
668,009 |
|
|
|
662,286 |
|
Long-term contingent acquisition
consideration payable |
|
|
135,275 |
|
|
|
32,663 |
|
Long-term deferred tax
liabilities |
|
|
143,527 |
|
|
|
143,527 |
|
Other long-term liabilities |
|
|
41,935 |
|
|
|
44,588 |
|
Total liabilities |
|
|
1,376,757 |
|
|
|
1,328,521 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value:
250,000,000 shares authorized at March 31, 2016 and December
31, 2015: 162,243,016 and 161,526,044 shares issued and
outstanding at March 31, 2016 and December 31, 2015,
respectively |
|
|
163 |
|
|
|
162 |
|
Additional paid-in capital |
|
|
3,410,297 |
|
|
|
3,414,837 |
|
Company common stock held by
Nonqualified Deferred Compensation Plan |
|
|
(13,560 |
) |
|
|
(13,616 |
) |
Accumulated other comprehensive
income |
|
|
47 |
|
|
|
21,033 |
|
Accumulated deficit |
|
|
(1,106,711 |
) |
|
|
(1,021,569 |
) |
Total stockholders’ equity |
|
|
2,290,236 |
|
|
|
2,400,847 |
|
Total liabilities and stockholders’
equity |
|
$ |
3,666,993 |
|
|
$ |
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 Months Ended March 31, 2016 and
2015 |
(In thousands of U.S. dollars, except per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2016 |
|
|
2015 |
|
REVENUES: |
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
235,357 |
|
|
$ |
201,312 |
|
Collaborative agreement
revenues |
|
|
233 |
|
|
|
376 |
|
Royalty, license and other
revenues |
|
|
1,146 |
|
|
|
1,232 |
|
Total revenues |
|
|
236,736 |
|
|
|
202,920 |
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
Cost of sales |
|
|
43,118 |
|
|
|
30,998 |
|
Research and development |
|
|
158,793 |
|
|
|
142,074 |
|
Selling, general and
administrative |
|
|
105,300 |
|
|
|
92,806 |
|
Intangible asset amortization and
contingent consideration |
|
|
10,442 |
|
|
|
2,902 |
|
Total operating expenses |
|
|
317,653 |
|
|
|
268,780 |
|
NET LOSS FROM
OPERATIONS |
|
|
(80,917 |
) |
|
|
(65,860 |
) |
Equity in the loss of
BioMarin/Genzyme LLC |
|
|
(135 |
) |
|
|
(150 |
) |
Interest income |
|
|
1,571 |
|
|
|
683 |
|
Interest expense |
|
|
(9,843 |
) |
|
|
(9,462 |
) |
Debt conversion
expense |
|
|
— |
|
|
|
(163 |
) |
Other income |
|
|
198 |
|
|
|
249 |
|
NET LOSS BEFORE
INCOME TAXES |
|
|
(89,126 |
) |
|
|
(74,703 |
) |
Benefit from income
taxes |
|
|
(3,984 |
) |
|
|
(7,202 |
) |
NET
LOSS |
|
$ |
(85,142 |
) |
|
$ |
(67,501 |
) |
NET LOSS PER
SHARE, BASIC AND DILUTED |
|
$ |
(0.53 |
) |
|
$ |
(0.43 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
161,548 |
|
|
|
157,612 |
|
|
|
|
|
|
|
|
|
|
Non-GAAP Loss
The results for the three months ended March 31,
2016 and 2015 include both GAAP net loss and non-GAAP loss. As used
in this release, non-GAAP loss is based on GAAP net loss and the
guidance for full-year net loss before interest, taxes,
depreciation and amortization and further adjusted to exclude
certain non-cash stock-based compensation expense, non-cash
contingent consideration expense and certain other specified items,
as detailed below (non-GAAP loss).
BioMarin believes that the non-GAAP information
in this press release is useful to investors, taken in conjunction
with BioMarin’s GAAP information because it provides additional
information regarding the performance of BioMarin’s core ongoing
business, Naglazyme, Vimizim, Kuvan, Aldurazyme and Firdapse and
development of its pipeline. By providing information about both
the overall GAAP financial performance and the non-GAAP measures
that focus on continuing operations, the Company believes that the
additional information enhances investors’ overall understanding of
the Company’s business and prospects for the future. Further,
the Company uses both the GAAP and the non-GAAP results and
expectations internally for its operating, budgeting and financial
planning purposes.
The following table presents the reconciliation
of GAAP to non-GAAP financial metrics:
|
Reconciliation of GAAP Net Loss to Non-GAAP
Loss |
(In millions of U.S. dollars) |
(Unaudited) |
|
|
|
|
|
|
Three Months Ended |
|
|
Year Ending |
|
March 31, |
|
|
December 31, 2016 |
|
2016 |
|
|
2015 |
|
|
Guidance |
|
|
|
|
|
|
|
|
|
|
GAAP Net
Loss |
$ |
(85.1 |
) |
|
$ |
(67.5 |
) |
|
$(355) to $(385) |
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
8.2 |
|
|
|
8.8 |
|
|
35.0 |
Benefit from income taxes |
|
(4.0 |
) |
|
|
(7.2 |
) |
|
(20.0)
- (57.0) |
Depreciation expense |
|
13.1 |
|
|
|
7.9 |
|
|
35.0 -
45.0 |
Amortization expense |
|
7.5 |
|
|
|
2.6 |
|
|
45.0 |
Stock-based compensation
expense |
|
30.2 |
|
|
|
22.7 |
|
|
140.0
- 167.0 |
Contingent consideration expense
(1) |
|
2.9 |
|
|
|
0.3 |
|
|
45.0 -
50.0 |
Acquisition expenses (2) |
|
— |
|
|
|
7.0 |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Non-GAAP
Loss |
$ |
(27.2 |
) |
|
$ |
(25.4 |
) |
|
$(75) to $(100) |
|
|
|
|
|
|
|
|
|
|
(1) Represents 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 developmental milestones.(2) The $7.0
million in the three months ended March 31, 2015, represents
transaction expenses for the acquisition of Prosensa Holding
N.V.
The following reconciliation of the Company’s GAAP Condensed
Consolidated Statements of Operations to non-GAAP Net Loss provides
the details of the effects of the non-GAAP adjustments on the
components of the Company’s operating results for each of the
periods presented. Management believes that providing the effects
of the non-GAAP adjustments on the components of operating results
is useful to investors and, when reviewed in conjunction with the
Company’s GAAP results, provides additional information regarding
key drivers of the Company’s core operations. The Company uses
operating results on both a GAAP and a non-GAAP basis internally
for operating, budgeting and financial planning purposes.
|
BIOMARIN PHARMACEUTICAL INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND RECONCILIATION OF non-GAAP ADJUSTMENTS |
Three Months Ended March 31, 2016 and
2015 |
(In millions of U.S. dollars) |
(Unaudited) |
|
|
|
|
Three Months Ended March 31, |
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
Non-GAAP Adjustments |
|
|
|
|
|
|
|
|
|
|
Non-GAAP Adjustments |
|
|
|
|
|
|
GAAP |
|
|
Interest, Taxes, Depreciation and
Amortization |
|
|
Stock-Based Compensation, Contingent
Consideration and Other Adjustments |
|
|
Non-GAAP |
|
|
GAAP |
|
|
Interest, Taxes, Depreciation and
Amortization |
|
|
Stock-Based Compensation, Contingent
Consideration and Other Adjustments |
|
|
Non-GAAP |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
$ |
235.4 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
235.4 |
|
|
$ |
201.3 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
201.3 |
|
Collaborative agreement
revenues |
|
0.2 |
|
|
|
— |
|
|
|
— |
|
|
|
0.2 |
|
|
|
0.4 |
|
|
|
— |
|
|
|
— |
|
|
|
0.4 |
|
Royalty, license and other
revenues |
|
1.1 |
|
|
|
— |
|
|
|
— |
|
|
|
1.1 |
|
|
|
1.2 |
|
|
|
— |
|
|
|
— |
|
|
|
1.2 |
|
Total revenues |
|
236.7 |
|
|
|
— |
|
|
|
— |
|
|
|
236.7 |
|
|
|
202.9 |
|
|
|
— |
|
|
|
— |
|
|
|
202.9 |
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
|
43.1 |
|
|
|
— |
|
|
|
(1.6 |
) |
|
|
41.5 |
|
|
|
31.0 |
|
|
|
— |
|
|
|
(1.3 |
) |
|
|
29.7 |
|
Research and development |
|
158.8 |
|
|
|
(7.4 |
) |
|
|
(13.7 |
) |
|
|
137.7 |
|
|
|
142.1 |
|
|
|
(3.6 |
) |
|
|
(10.0 |
) |
|
|
128.5 |
|
Selling, general and
administrative |
|
105.3 |
|
|
|
(5.7 |
) |
|
|
(14.9 |
) |
|
|
84.7 |
|
|
|
92.8 |
|
|
|
(4.3 |
) |
|
|
(18.4 |
) |
|
|
70.1 |
|
Intangible asset amortization
and contingent consideration |
|
10.4 |
|
|
|
(7.5 |
) |
|
|
(2.9 |
) |
|
|
— |
|
|
|
2.9 |
|
|
|
(2.6 |
) |
|
|
(0.3 |
) |
|
|
— |
|
Total operating expenses |
|
317.6 |
|
|
|
(20.6 |
) |
|
|
(33.1 |
) |
|
|
263.9 |
|
|
|
268.8 |
|
|
|
(10.5 |
) |
|
|
(30.0 |
) |
|
|
228.3 |
|
LOSS FROM
OPERATIONS |
|
(80.9 |
) |
|
|
20.6 |
|
|
|
33.1 |
|
|
|
(27.2 |
) |
|
|
(65.9 |
) |
|
|
10.5 |
|
|
|
30.0 |
|
|
|
(25.4 |
) |
Equity in the loss
of BioMarin/Genzyme LLC |
|
(0.1 |
) |
|
|
— |
|
|
|
— |
|
|
|
(0.1 |
) |
|
|
(0.2 |
) |
|
|
— |
|
|
|
— |
|
|
|
(0.2 |
) |
Interest income |
|
1.6 |
|
|
|
(1.6 |
) |
|
|
— |
|
|
|
— |
|
|
|
0.7 |
|
|
|
(0.7 |
) |
|
|
— |
|
|
|
— |
|
Interest expense |
|
(9.8 |
) |
|
|
9.8 |
|
|
|
— |
|
|
|
— |
|
|
|
(9.5 |
) |
|
|
9.5 |
|
|
|
— |
|
|
|
— |
|
Debt conversion
expense |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(0.2 |
) |
|
|
— |
|
|
|
— |
|
|
|
(0.2 |
) |
Other income |
|
0.1 |
|
|
|
— |
|
|
|
— |
|
|
|
0.1 |
|
|
|
0.4 |
|
|
|
— |
|
|
|
— |
|
|
|
0.4 |
|
LOSS BEFORE
INCOME TAXES |
|
(89.1 |
) |
|
|
28.8 |
|
|
|
33.1 |
|
|
|
(27.2 |
) |
|
|
(74.7 |
) |
|
|
19.3 |
|
|
|
30.0 |
|
|
|
(25.4 |
) |
Benefit from income
taxes |
|
(4.0 |
) |
|
|
4.0 |
|
|
|
— |
|
|
|
— |
|
|
|
(7.2 |
) |
|
|
7.2 |
|
|
|
— |
|
|
|
— |
|
NET
LOSS |
$ |
(85.1 |
) |
|
$ |
24.8 |
|
|
$ |
33.1 |
|
|
$ |
(27.2 |
) |
|
$ |
(67.5 |
) |
|
$ |
12.1 |
|
|
$ |
30.0 |
|
|
$ |
(25.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following summarizes the reconciliation of the components of
the non-GAAP adjustments to Cost of sales, Research and development
and Selling, general and administrative expenses from the GAAP to
the non-GAAP presentation (in millions of U.S. dollars,
unaudited):
|
|
|
Three Months Ended December 31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
Cost of sales -
GAAP |
$ |
43.1 |
|
|
$ |
31.0 |
|
Less: non-GAAP
adjustments: |
|
|
|
Stock-based compensation |
|
(1.6 |
) |
|
|
(1.3 |
) |
Cost of sales -
non-GAAP |
$ |
41.5 |
|
|
$ |
29.7 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
Research and
development - GAAP |
$ |
158.8 |
|
|
$ |
142.1 |
|
Less: non-GAAP
adjustments: |
|
|
|
Stock-based compensation |
|
(13.7 |
) |
|
|
(10.0 |
) |
Depreciation |
|
(7.4 |
) |
|
|
(3.6 |
) |
Research and
development - non-GAAP |
$ |
137.7 |
|
|
$ |
128.5 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
Selling, general and
administrative - GAAP |
$ |
105.3 |
|
|
$ |
92.8 |
|
Less: non-GAAP
adjustments: |
|
|
|
Stock-based compensation |
|
(14.9 |
) |
|
|
(11.4 |
) |
Depreciation |
|
(5.7 |
) |
|
|
(4.3 |
) |
Acquisition expenses |
|
— |
|
|
|
(7.0 |
) |
Selling,
general and administrative -
non-GAAP |
$ |
84.7 |
|
|
$ |
70.1 |
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
|
2015 |
|
|
|
2014 |
|
|
|
|
|
Intangible asset
amortization and contingent consideration - GAAP |
$ |
10.4 |
|
|
$ |
2.9 |
|
Less: non-GAAP
adjustments |
|
|
|
Intangible asset amortization |
|
(7.5 |
) |
|
|
(2.6 |
) |
Contingent consideration |
|
(2.9 |
) |
|
|
(0.3 |
) |
Intangible
asset amortization and contingent
consideration - non-GAAP |
$ |
— |
|
|
$ |
— |
|
|
|
|
|
Contact:
Investors:
Traci McCarty
BioMarin Pharmaceutical Inc.
(415) 455-7558
Media:
Debra Charlesworth
BioMarin Pharmaceutical Inc.
(415) 455-7451
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