- Second Quarter 2016 Total BioMarin
Revenue Increases 20.0% Y/Y to $300.1 million
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) today announced
financial results for the second quarter ended June 30, 2016. GAAP
net loss was $423.6 million, or $(2.61) per basic and diluted share
for the second quarter of 2016, compared to GAAP net loss of $82.0
million, or $(0.51) per basic and diluted share, for the second
quarter of 2015. The increased GAAP net loss compared to the prior
year quarter was primarily due to impairment and related charges,
net of tax, resulting from the termination of the Kyndrisa
development program in the second quarter.
Non-GAAP income was $16.1 million for the
quarter ended June 30, 2016, compared to non-GAAP loss of $5.8
million for the second quarter of 2015. The increase in non-GAAP
income compared to the prior year quarter was primarily due to
increased gross margins from strong Kuvan and Vimizim net product
revenues, partially offset by increased non-GAAP selling, general
and administrative expense for Vimizim and Kuvan, and non-GAAP
research and development expense.
Total BioMarin Revenue was $300.1 million for
the second quarter of 2016, an increase of 20.0% compared to the
same period in 2015. This strong result was driven by year over
year growth of 98.1% and 50.1% of Vimizim and Kuvan, respectively.
Vimizim net product revenue growth was driven primarily by robust
patient growth and in part by the timing of large orders from Latin
America and the Middle East. Kuvan revenue growth was driven by
patient increases in North America and strong sales in
international territories. Kuvan revenue from ex-North America
territories since BioMarin acquired worldwide rights in January
2016 contributed $22.0 million and revenues in North America
contributed $68.2 million in the quarter. Naglazyme patient growth
was 9.2% compared to a year ago. Naglazyme revenue in the second
quarter 2016 was lower than revenue in the second quarter 2015
primarily due to the timing of central government orders from Latin
America in 2015.
As of June 30, 2016, BioMarin had cash, cash
equivalents and investments totaling $704.9 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,
“In the first half of 2016 we made tremendous progress moving our
development pipeline forward while driving our established
commercial business to record levels. The increase in Total
BioMarin Revenue guidance for 2016 is testament to the innovation
BioMarin provides patients, mostly children, with rare and
ultra-rare disorders. Prospects for new product launches in 2017
increased during the first half of the year due to positive data
readouts for Brineura and pegvaliase.”
Mr. Bienaimé continued, “We are pleased that
last week the U.S. Food and Drug Administration 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. With the Prescription Drug User
Fee Act (PDUFA) goal date for an approval decision of January 27,
2017, we are one step closer to potentially providing a treatment
option for this devastating childhood disease. We have also filed
the Marketing Authorization Application in Europe for Brineura. In
addition, at the World Federation of Hemophilia Congress last week,
we announced positive proof-of-concept data with our gene therapy
product candidate BMN 270 for hemophilia A and plans to start a
Phase 2b study in mid-2017. Also in the quarter at R&D Day, we
shared robust 12-month data with vosoritide for achondroplasia. If
the data from these programs continue to mature as we hope, we
believe that these product candidates could each ultimately drive a
billion dollars in annual revenue when commercialized.”
Net Product Revenue (in
millions of U.S. dollars, unaudited) |
|
|
|
|
|
|
|
Total Revenue |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
|
% Change |
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vimizim (1) |
|
$ |
106.8 |
|
|
$ |
53.9 |
|
|
$ |
52.9 |
|
|
|
98.1 |
% |
|
$ |
179.4 |
|
|
$ |
104.5 |
|
|
$ |
74.9 |
|
|
|
71.7 |
% |
Naglazyme (1) |
|
|
78.4 |
|
|
|
111.1 |
|
|
|
(32.7 |
) |
|
|
(29.4 |
)% |
|
|
143.8 |
|
|
|
189.3 |
|
|
|
(45.5 |
) |
|
|
(24.0 |
)% |
Kuvan (2) |
|
|
90.2 |
|
|
|
60.1 |
|
|
|
30.1 |
|
|
|
50.1 |
% |
|
|
166.9 |
|
|
|
110.3 |
|
|
|
56.6 |
|
|
|
51.3 |
% |
Aldurazyme |
|
|
18.7 |
|
|
|
20.2 |
|
|
|
(1.5 |
) |
|
|
(7.4 |
)% |
|
|
35.1 |
|
|
|
38.4 |
|
|
|
(3.3 |
) |
|
|
(8.6 |
)% |
Firdapse |
|
|
4.5 |
|
|
|
3.7 |
|
|
|
0.8 |
|
|
|
21.6 |
% |
|
|
8.7 |
|
|
|
7.8 |
|
|
|
0.9 |
|
|
|
11.5 |
% |
Net
product revenues |
|
|
298.6 |
|
|
|
249.0 |
|
|
|
49.6 |
|
|
|
19.9 |
% |
|
|
533.9 |
|
|
|
450.3 |
|
|
|
83.6 |
|
|
|
18.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaborative agreement
revenues |
|
|
- |
|
|
|
0.3 |
|
|
|
(0.3 |
) |
|
|
|
|
|
|
0.2 |
|
|
|
0.7 |
|
|
|
(0.5 |
) |
|
|
|
|
Royalty, license and
other revenues |
|
|
1.5 |
|
|
|
0.8 |
|
|
|
0.7 |
|
|
|
|
|
|
|
2.8 |
|
|
|
2.1 |
|
|
|
0.7 |
|
|
|
|
|
Total
BioMarin revenues |
|
$ |
300.1 |
|
|
$ |
250.1 |
|
|
$ |
50.0 |
|
|
|
20.0 |
% |
|
$ |
536.9 |
|
|
$ |
453.1 |
|
|
$ |
83.8 |
|
|
|
18.5 |
% |
|
(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 $68.2 million in the second quarter with an additional
$22.0 million coming from newly acquired ex-North American
territories. |
|
Details of Net Product Revenue Attributable to
Aldurazyme |
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
|
% Change |
|
|
2016 |
|
|
2015 |
|
|
$ Change |
|
|
% Change |
|
Aldurazyme revenue
reported by Genzyme |
|
$ |
56.8 |
|
|
$ |
56.5 |
|
|
$ |
0.3 |
|
|
|
0.5 |
% |
|
$ |
109.6 |
|
|
$ |
109.9 |
|
|
$ |
(0.3 |
) |
|
|
(0.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
|
Three
Months Ended June 30, |
|
|
|
|
|
|
|
|
|
Six Months
Ended June 30, |
|
|
|
2016 |
|
2015 |
|
$
Change |
|
|
|
|
|
|
|
|
|
2016 |
|
2015 |
|
$
Change |
Royalties earned from Genzyme |
|
$ |
22.8 |
|
|
$ |
23.5 |
|
|
$ |
(0.7 |
) |
|
|
|
|
|
|
|
|
|
$ |
44.3 |
|
|
$ |
45.8 |
|
|
$ |
(1.5 |
) |
Net product transfer revenues (3) |
|
|
(4.1 |
) |
|
|
(3.3 |
) |
|
|
(0.8 |
) |
|
|
|
|
|
|
|
|
|
|
(9.2 |
) |
|
|
(7.4 |
) |
|
|
(1.8 |
) |
Total Aldurazyme net product revenues |
|
$ |
18.7 |
|
|
$ |
20.2 |
|
|
$ |
(1.5 |
) |
|
|
|
|
|
|
|
|
|
$ |
35.1 |
|
|
$ |
38.4 |
|
|
$ |
(3.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
(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. |
|
Impairment of Intangible Assets and Related Charges and
Adjustments
During the three months ended June 30, 2016, the
Company incurred impairment charges and made other adjustments
related to the Kyndrisa and related exons and the reveglucosidase
alfa programs. In May 2016, the Company withdrew its Marketing
Authorization Application for the approval of Kyndrisa from the
European Medicines Agency. Additionally, in June 2016, the Company
discontinued the clinical and regulatory development program for
reveglucosidase alfa. Following these events, the Company
determined the IPR&D intangible assets related to these
programs were fully impaired, resulting in a total impairment
charge of $599.1 million. Additionally, the Company reversed the
contingent acquisition consideration liabilities as it was
determined that achievement of certain future regulatory and
commercial milestones associated with these programs was no longer
probable, resulting in a $64.9 million credit to Contingent
consideration expense for the period. Also related to the
impairment of the IPR&D assets, the Company reversed certain
deferred tax liabilities associated with the future amortization of
the IPR&D intangible assets, resulting in a $153.5 million
credit to the Benefit from income taxes for the period.
The following table summarizes the impact of
these impairments and related adjustments on the Company’s
Condensed Consolidated Statements of Operations for the three and
six months ended June 30, 2016 (in millions of U.S. dollars):
|
Kyndrisa |
|
|
Reveglucosidase alfa |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment of intangible assets |
$ |
574.1 |
|
|
$ |
25.0 |
|
|
$ |
599.1 |
|
Contingent consideration expense |
|
(43.8 |
) |
|
|
(21.1 |
) |
|
|
(64.9 |
) |
Benefit
from income taxes |
|
(143.5 |
) |
|
|
(10.0 |
) |
|
|
(153.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net
impact |
$ |
386.8 |
|
|
$ |
(6.1 |
) |
|
$ |
380.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Updated 2016 Financial
Guidance |
|
|
|
|
|
Revenue Guidance ($ in
millions) |
|
|
|
|
|
Item |
|
|
|
|
|
|
Provided April
28, 2016 |
|
Updated August
4, 2016 |
Total BioMarin Revenues |
|
$1,050 to $1,100 |
|
$1,100 to $1,150 |
Vimizim Net Product Revenue |
|
$315 to $340 |
|
$340 to $360 |
Naglazyme Net Product Revenue |
|
$290 to $320 |
|
Unchanged |
Kuvan Net Product Revenue |
|
$320 to $350 |
|
$340 to $360 |
|
|
|
|
|
Select Income Statement Guidance ($
in millions, except percentages) |
|
|
|
|
|
Item |
|
|
|
|
|
|
Provided April
28, 2016 |
|
Updated August
4, 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 |
|
$670 to $690 |
GAAP Net Loss |
|
$(355) to $(385) |
|
$(620) to $(650) |
non-GAAP Loss |
|
$(75) to $(100) |
|
$(30) to $(50) |
|
|
|
|
|
Recent Key Program Updates
- BMN 270 gene therapy product for hemophilia A:
The Company is currently conducting a Phase 1/2
first-in-human, dose escalation study in severe hemophilia A
patients. A total of nine patients with severe hemophilia A have
received a single dose of BMN 270, seven 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 12 to 28
weeks. To date, the study has demonstrated significant factor VIII
expression with a good safety profile. Last week at the World
Federation of Hemophilia Congress, the Company announced that as of
July 6th, 6 of 7 patients receiving the high dose of BMN 270 had
factor VIII levels above 50%, and the 7th was above 10%.
While the one patient who was above 10% and below 50% now appears
to have Factor VIII levels above 5%, all high dose patients
continue to be in the mild or better hemophilia A range.
With these interim results having established proof of concept for
BMN 270, BioMarin’s next step is to go into a Phase 2b study that
could potentially be registration enabling.
- Vosoritide for achondroplasia: The Company
provided an update at R&D Day April 20, 2016 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). The
Company expects to provide an update on 6-month data from the 4th
cohort of patients who received 30 µg/kg/day dose of vosoritide in
the second half of 2016 at a medical meeting. BioMarin plans to
initiate a Phase 3 study with Vosoritide by
year-end.
- Brineura (formerly known as Cerliponase alfa) for CLN2,
late-infantile form of Batten disease: On July 28th, 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
Prescription Drug User Fee Act (PDUFA) goal date for a decision is
January 27, 2017. BioMarin also has submitted a Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for Brineura, and it is undergoing validation at the Agency.
The FDA granted Brineura Priority Review status, which is
designated to 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. (See BioMarin press release from July 27,
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 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 fourth quarter of 2016 or the first quarter of
2017.
Conference Call Details
BioMarin will host a conference call and webcast
to discuss second quarter 2016 financial results today, Thursday,
August 4, 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: 40166552
Replay Dial-in Number: 855.859.2056Replay
International Dial-in Number: 404.537.3406Conference ID:
40166552
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 expenses related to Vimizim, Naglazyme, Kuvan, Firdapse, and
Aldurazyme; the financial performance of BioMarin as a whole; the
timing of BioMarin's clinical trials; the continued clinical
development and commercialization of Vimizim, Naglazyme, Kuvan,
Firdapse, Aldurazyme and BioMarin’s 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: 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. 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 |
June 30,
2016 and December 31, 2015 |
(In
thousands of U.S. dollars, except share and per share
amounts) |
|
|
|
June 30, 2016 |
|
|
December 31, 2015(1) |
|
ASSETS |
|
(unaudited) |
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
305,969 |
|
|
$ |
397,040 |
|
Short-term
investments |
|
|
197,318 |
|
|
|
195,579 |
|
Accounts
receivable, net (allowance for doubtful accounts: $132 and
$93, at June 30, 2016 and December 31, 2015,
respectively) |
|
|
214,158 |
|
|
|
164,959 |
|
Inventory |
|
|
326,556 |
|
|
|
271,683 |
|
Other
current assets |
|
|
61,945 |
|
|
|
60,378 |
|
Total
current assets |
|
|
1,105,946 |
|
|
|
1,089,639 |
|
Noncurrent assets: |
|
|
|
|
|
|
|
|
Long-term
investments |
|
|
201,620 |
|
|
|
425,652 |
|
Property,
plant and equipment, net |
|
|
724,494 |
|
|
|
704,207 |
|
Intangible
assets, net |
|
|
568,966 |
|
|
|
683,996 |
|
Goodwill |
|
|
197,039 |
|
|
|
197,039 |
|
Long-term
deferred tax assets |
|
|
266,182 |
|
|
|
220,191 |
|
Other
assets |
|
|
23,057 |
|
|
|
408,644 |
|
Total
assets |
|
$ |
3,087,304 |
|
|
$ |
3,729,368 |
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
|
292,342 |
|
|
|
392,511 |
|
Short-term
convertible debt, net |
|
|
24,420 |
|
|
|
— |
|
Short-term
contingent acquisition consideration payable |
|
|
47,818 |
|
|
|
52,946 |
|
Total
current liabilities |
|
|
364,580 |
|
|
|
445,457 |
|
Noncurrent
liabilities: |
|
|
|
|
|
|
|
|
Long-term convertible
debt |
|
|
645,685 |
|
|
|
662,286 |
|
Long-term
contingent acquisition consideration payable |
|
|
120,151 |
|
|
|
32,663 |
|
Long-term
deferred tax liabilities |
|
|
— |
|
|
|
143,527 |
|
Other
long-term liabilities |
|
|
39,312 |
|
|
|
44,588 |
|
Total
liabilities |
|
|
1,169,728 |
|
|
|
1,328,521 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common
stock, $0.001 par value: 250,000,000 shares authorized at
June 30, 2016 and December 31, 2015: 163,282,081 and 161,526,044
shares issued and outstanding at June 30, 2016 and
December 31, 2015, respectively |
|
|
164 |
|
|
|
162 |
|
Additional
paid-in capital |
|
|
3,458,124 |
|
|
|
3,414,837 |
|
Company
common stock held by Nonqualified Deferred Compensation Plan |
|
|
(14,969 |
) |
|
|
(13,616 |
) |
Accumulated
other comprehensive income |
|
|
4,528 |
|
|
|
21,033 |
|
Accumulated
deficit |
|
|
(1,530,271 |
) |
|
|
(1,021,569 |
) |
Total
stockholders’ equity |
|
|
1,917,576 |
|
|
|
2,400,847 |
|
Total
liabilities and stockholders’ equity |
|
$ |
3,087,304 |
|
|
$ |
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
Six Months Ended June 30, 2016 and 2015 |
(In
thousands of U.S. dollars, except per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product
revenues |
|
$ |
298,576 |
|
|
$ |
249,023 |
|
|
$ |
533,933 |
|
|
$ |
450,335 |
|
Collaborative agreement revenues |
|
|
— |
|
|
|
342 |
|
|
|
233 |
|
|
|
718 |
|
Royalty,
license and other revenues |
|
|
1,555 |
|
|
|
770 |
|
|
|
2,701 |
|
|
|
2,002 |
|
Total
revenues |
|
|
300,131 |
|
|
|
250,135 |
|
|
|
536,867 |
|
|
|
453,055 |
|
OPERATING
EXPENSES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
sales |
|
|
51,617 |
|
|
|
38,063 |
|
|
|
94,735 |
|
|
|
69,061 |
|
Research and
development |
|
|
167,039 |
|
|
|
157,901 |
|
|
|
325,832 |
|
|
|
299,975 |
|
Selling,
general and administrative |
|
|
109,577 |
|
|
|
101,514 |
|
|
|
214,877 |
|
|
|
194,320 |
|
Intangible
asset amortization and contingent consideration |
|
|
(54,414 |
) |
|
|
16,945 |
|
|
|
(43,972 |
) |
|
|
19,847 |
|
Impairment
of intangible assets |
|
|
599,118 |
|
|
|
— |
|
|
|
599,118 |
|
|
|
— |
|
Total
operating expenses |
|
|
872,937 |
|
|
|
314,423 |
|
|
|
1,190,590 |
|
|
|
583,203 |
|
LOSS FROM
OPERATIONS |
|
|
(572,806 |
) |
|
|
(64,288 |
) |
|
|
(653,723 |
) |
|
|
(130,148 |
) |
Equity in the loss of
BioMarin/Genzyme LLC |
|
|
(135 |
) |
|
|
(203 |
) |
|
|
(270 |
) |
|
|
(353 |
) |
Interest income |
|
|
1,357 |
|
|
|
1,023 |
|
|
|
2,928 |
|
|
|
1,706 |
|
Interest expense |
|
|
(9,944 |
) |
|
|
(10,002 |
) |
|
|
(19,787 |
) |
|
|
(19,464 |
) |
Debt conversion
expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(163 |
) |
Other expense |
|
|
(1,417 |
) |
|
|
(9,073 |
) |
|
|
(1,219 |
) |
|
|
(8,824 |
) |
LOSS BEFORE INCOME
TAXES |
|
|
(582,945 |
) |
|
|
(82,543 |
) |
|
|
(672,071 |
) |
|
|
(157,246 |
) |
Benefit from income
taxes |
|
|
(159,385 |
) |
|
|
(554 |
) |
|
|
(163,369 |
) |
|
|
(7,756 |
) |
NET
LOSS |
|
$ |
(423,560 |
) |
|
$ |
(81,989 |
) |
|
$ |
(508,702 |
) |
|
$ |
(149,490 |
) |
NET LOSS PER
SHARE, BASIC AND DILUTED |
|
$ |
(2.61 |
) |
|
$ |
(0.51 |
) |
|
$ |
(3.14 |
) |
|
$ |
(0.94 |
) |
Weighted average common
shares outstanding, basic and diluted |
|
|
162,587 |
|
|
|
160,406 |
|
|
|
162,067 |
|
|
|
159,017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP Information
The results presented in this press release for
the three and six months ended June 30, 2016 and 2015 include both
GAAP information and non-GAAP information. As used in this release,
non-GAAP information is based on reported GAAP net loss and the
guidance for full-year GAAP net loss before interest, income 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. In addition, BioMarin includes in this press
release the effects of these non-GAAP adjustments on certain
components of GAAP net loss for each of the periods presented. In
this regard, non-GAAP information 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 the Company’s core
operating performance, as support for budgeting and financial
planning purposes and to evaluate key business decisions. Because
the non-GAAP information 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’ understanding because it provides additional
information regarding the performance of BioMarin’s core operating
results and business and development of its pipeline.
The non-GAAP information and its components are
not meant to be considered in isolation or as a substitute for
comparable GAAP measures and should be read in conjunction with the
consolidated financial information prepared in accordance with
GAAP. Investors should note that the non-GAAP information is not
prepared under any comprehensive set of accounting rules or
principles and does not reflect all of the amounts associated with
the Company’s results of operations as determined in accordance
with GAAP. Investors should also note that these non-GAAP measures
have no standardized meaning prescribed by GAAP and, therefore,
have limits in their usefulness to investors. In addition, from
time to time in the future there may be other items that the
Company may exclude for purposes of its non-GAAP measures;
likewise, the Company may in the future cease to exclude items that
it has historically excluded for purposes of its non-GAAP measures.
Because of the non-standardized definitions, the non-GAAP measure
as used by BioMarin in this press release and the accompanying
tables may be calculated differently from, and therefore may not be
directly comparable to, similarly titled measures used by other
companies.
The following table presents the reconciliation
of GAAP Net Loss to non-GAAP Income (Loss):
Reconciliation of GAAP Net Loss to non-GAAP
Income (Loss) |
(In millions of U.S. dollars) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
Year Ending |
|
June 30, |
|
|
June 30, |
|
|
December 31, 2016 |
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
Guidance |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net
Loss |
$ |
(423.6 |
) |
|
$ |
(82.0 |
) |
|
$ |
(508.7 |
) |
|
$ |
(149.5 |
) |
|
$(620.0) to $(650.0) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense, net |
|
8.6 |
|
|
|
9.0 |
|
|
|
16.9 |
|
|
|
17.8 |
|
|
35.0 |
Benefit
from income taxes |
|
(159.4 |
) |
|
|
(0.6 |
) |
|
|
(163.4 |
) |
|
|
(7.8 |
) |
|
(195.0) - (215.0) |
Depreciation expense |
|
11.9 |
|
|
|
8.5 |
|
|
|
25.0 |
|
|
|
16.4 |
|
|
45.0 -
55.0 |
Amortization expense |
|
7.6 |
|
|
|
2.6 |
|
|
|
15.1 |
|
|
|
5.2 |
|
|
30.0 |
Stock-based compensation expense |
|
33.9 |
|
|
|
29.6 |
|
|
|
64.1 |
|
|
|
52.2 |
|
|
121.0
- 146.0 |
Contingent consideration expense (1) |
|
(62.0 |
) |
|
|
14.3 |
|
|
|
(59.1 |
) |
|
|
14.6 |
|
|
(50.0)
- (60.0) |
Acquisition expenses (2) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7.0 |
|
|
- |
Impairment charges (3) |
|
599.1 |
|
|
|
12.8 |
|
|
|
599.1 |
|
|
|
12.8 |
|
|
599.0 |
Restructuring charges (4) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
5.0 -
10.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
non-GAAP Income
(Loss) |
$ |
16.1 |
|
|
$ |
(5.8 |
) |
|
$ |
(11.0 |
) |
|
$ |
(31.3 |
) |
|
$(30.0) to $(50.0) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 Six Months Ended June 30, 2016 and
2015 |
(In millions of U.S. dollars) |
(Unaudited) |
|
|
|
|
Three Months Ended June 30, |
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
GAAPReported |
|
|
Interest, Taxes, Depreciation and Amortization |
|
|
Stock-Based Compensation, Contingent Consideration and
Other Adjustments |
|
|
non-GAAP |
|
|
GAAPReported |
|
|
Interest, Taxes, Depreciation and Amortization |
|
|
Stock-Based Compensation, Contingent Consideration and
OtherAdjustments |
|
|
non-GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
$ |
51.6 |
|
|
$ |
- |
|
|
$ |
(2.3 |
) |
|
$ |
49.3 |
|
|
$ |
38.1 |
|
|
$ |
- |
|
|
$ |
(1.8 |
) |
|
$ |
36.3 |
|
Research and
development |
|
167.0 |
|
|
|
(6.0 |
) |
|
|
(14.8 |
) |
|
|
146.2 |
|
|
|
157.9 |
|
|
|
(3.9 |
) |
|
|
(12.5 |
) |
|
|
141.5 |
|
Selling, general and
administrative (2) |
|
109.6 |
|
|
|
(5.9 |
) |
|
|
(16.8 |
) |
|
|
86.9 |
|
|
|
101.5 |
|
|
|
(4.6 |
) |
|
|
(15.3 |
) |
|
|
81.6 |
|
Intangible asset
amortization and contingent consideration (1) |
|
(54.4 |
) |
|
|
(7.6 |
) |
|
|
62.0 |
|
|
|
— |
|
|
|
16.9 |
|
|
|
(2.6 |
) |
|
|
(14.3 |
) |
|
|
— |
|
Impairment of intangible
assets (3) |
|
599.1 |
|
|
|
— |
|
|
|
(599.1 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Interest expense, net |
|
(8.6 |
) |
|
|
8.6 |
|
|
|
— |
|
|
|
— |
|
|
|
(9.0 |
) |
|
|
9.0 |
|
|
|
— |
|
|
|
— |
|
Other income
(expense) |
|
(1.5 |
) |
|
|
— |
|
|
|
— |
|
|
|
(1.5 |
) |
|
|
(9.3 |
) |
|
|
— |
|
|
|
12.8 |
|
|
|
3.5 |
|
Benefit from income
taxes |
|
(159.4 |
) |
|
|
159.4 |
|
|
|
— |
|
|
|
— |
|
|
|
(0.6 |
) |
|
|
0.6 |
|
|
|
— |
|
|
|
— |
|
Net Income (Loss)/non-GAAP
Income (Loss) |
|
(423.6 |
) |
|
|
(131.3 |
) |
|
|
571.0 |
|
|
|
16.1 |
|
|
|
(82.0 |
) |
|
|
19.5 |
|
|
|
56.7 |
|
|
|
(5.8 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
GAAPReported |
|
|
Interest, Taxes, Depreciation and Amortization |
|
|
Stock-Based Compensation, Contingent Consideration and
Other Adjustments |
|
|
non-GAAP |
|
|
GAAPReported |
|
|
Interest, Taxes, Depreciationand Amortization |
|
|
Stock-Based Compensation, Contingent Consideration and
Other Adjustments |
|
|
non-GAAP |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of sales |
$ |
94.7 |
|
|
$ |
- |
|
|
$ |
(3.9 |
) |
|
$ |
90.8 |
|
|
$ |
69.1 |
|
|
$ |
- |
|
|
$ |
(3.1 |
) |
|
$ |
66.0 |
|
Research and
development |
|
325.8 |
|
|
|
(13.4 |
) |
|
|
(28.5 |
) |
|
|
283.9 |
|
|
|
300.0 |
|
|
|
(7.5 |
) |
|
|
(22.4 |
) |
|
|
270.1 |
|
Selling, general and
administrative (2) |
|
214.9 |
|
|
|
(11.6 |
) |
|
|
(31.7 |
) |
|
|
171.6 |
|
|
|
194.3 |
|
|
|
(8.9 |
) |
|
|
(33.7 |
) |
|
|
151.7 |
|
Intangible asset
amortization and contingent consideration (1) |
|
(44.0 |
) |
|
|
(15.1 |
) |
|
|
59.1 |
|
|
|
— |
|
|
|
19.8 |
|
|
|
(5.2 |
) |
|
|
(14.6 |
) |
|
|
— |
|
Impairment of intangible
assets (3) |
|
599.1 |
|
|
|
— |
|
|
|
(599.1 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Interest expense, net |
|
(16.9 |
) |
|
|
16.9 |
|
|
|
— |
|
|
|
— |
|
|
|
(17.8 |
) |
|
|
17.8 |
|
|
|
— |
|
|
|
— |
|
Other income
(expense) |
|
(1.6 |
) |
|
|
— |
|
|
|
— |
|
|
|
(1.6 |
) |
|
|
(9.4 |
) |
|
|
— |
|
|
|
12.8 |
|
|
|
3.4 |
|
Benefit from income
taxes |
|
(163.4 |
) |
|
|
163.4 |
|
|
|
— |
|
|
|
— |
|
|
|
(7.8 |
) |
|
|
7.8 |
|
|
|
— |
|
|
|
— |
|
Net Income (Loss)/non-GAAP
Income (Loss) |
|
(508.7 |
) |
|
|
(106.4 |
) |
|
|
604.1 |
|
|
|
(11.0 |
) |
|
|
(149.5 |
) |
|
|
31.6 |
|
|
|
86.6 |
|
|
|
(31.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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 developmental milestones. Amounts for the three
months ended June 30, 2016 include $43.8 million and $21.1 million
related to the change in probability of achieving the Kyndrisa and
Reveglucosidase alfa development milestones, respectively. |
(2)
Includes $7.0 million of acquisition costs for the six months ended
June 30, 2015 related to the acquisition of Prosensa Holdings
N.V. |
(3)
Includes $574.1 million and $25.0 million for the impairment of
intangible assets associated with the discontinuance of the
Kyndrisa and Reveglucosidase alfa development programs,
respectively, during the three months ended June 30, 2016. |
(4)
Represents estimated restructuring charges for expected headcount
reductions to be incurred in the second half of 2016, following an
approved plan of restructuring resulting from the Kyndrisa program
termination. |
|
Contact:
Investors:
Traci McCarty
BioMarin Pharmaceutical Inc.
(415) 455-7558
Media:
Debra Charlesworth
BioMarin Pharmaceutical Inc.
(415) 455-7451
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