BioMarin Announces Fourth Quarter and Full Year 2017 Financial Results
SAN RAFAEL, Calif., Feb. 22, 2018 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended Twelve Months Ended
December 31,
December 31,
------------
2017 2016 % Change 2017 2016 % Change
---- ---- -------- ---- ---- --------
Total Revenues $358.3 $300.1 19% $1,313.6 $1,116.9 18%
Aldurazyme Net
Product
Revenues 28.3 35.0 (19)% 90.0 93.8 (4)%
Brineura Net
Product
Revenues 5.2 - n/a 8.6 - n/a
Kuvan Net
Product
Revenues 107.4 90.2 19% 407.5 348.0 17%
Naglazyme Net
Product
Revenues 93.8 74.9 25% 332.2 296.5 12%
Vimizim Net
Product
Revenues 114.0 93.8 22% 413.3 354.1 17%
GAAP Net Loss $(51.4) $(90.7) $(117.0) $(630.2)
GAAP Net Loss
per Share -
Basic (0.29) (0.53) (0.67) (3.80)
GAAP Net Loss
per Share -
Diluted (0.30) (0.53) (0.67) (3.81)
Non-GAAP
Income (Loss)
(1) $5.2 $(27.5) $74.0 $(36.5)
December 31, December 31,
2017 2016
---- ----
Cash, cash
equivalents
and
investments $1,781.7 $1,362.4
(1) Non-GAAP Income (Loss) is defined
by the Company as reported GAAP
Net Income (Loss), excluding net
interest expense, provision for
(benefit from) income taxes,
depreciation expense, amortization
expense, stock-based compensation
expense, contingent consideration
expense and, in certain periods,
certain other specified items as
detailed below. Refer to Non-GAAP
Information beginning on page 10
of this press release for a
complete discussion of the
Company's Non-GAAP financial
information and reconciliations to
the comparable GAAP reported
information.
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced financial results for the fourth quarter and year ended December 31, 2017. For the quarter ended December 31, 2017 GAAP Net Loss was $51.4 million, or $0.29 and $0.30 per basic and diluted share, respectively, compared to GAAP Net Loss of $90.7 million, or $0.53 per basic and diluted share, respectively, for the quarter ended December 31, 2016. GAAP Net Loss for the year ended December 31, 2017 was $117.0 million, or $0.67 per basic and diluted share, respectively, compared to GAAP Net Loss of $630.2 million, or $3.80 and $3.81 per basic and diluted share, respectively, for the year ended December 31, 2016. The reduction in GAAP Net Loss year over year was primarily due to increased net product revenues for Kuvan, Naglazyme and Vimizim, the $31.5 million net upfront license payment received from Sarepta Therapeutics Inc. (Sarepta) in connection with the settlement of the Company's patent proceedings against Sarepta, the $125.0 million gain on sale of intangible assets related to the sale of the Priority Review Voucher, and the absence of the impairment of intangible assets associated with the discontinuance of the Kyndrisa and reveglucosidase alfa programs in 2016, partially offset by an increase in the provision for income taxes related to the impact of the Tax Cuts and Jobs Act on the Company's operating results.
Non-GAAP Income for the three months ended December 31, 2017 was $5.2 million, compared to Non-GAAP Loss of $27.5 million for the three months ended December 31, 2016. Non-GAAP Income for the year ended December 31, 2017 was $74.0 million, compared to Non-GAAP Loss of $36.5 million for the year ended December 31, 2016.
Total Revenues were $1.3 billion for the year ended December 31, 2017 compared to $1.1 billion for the year ended December 31, 2016, an increase of 18%. For the year ended December 31, 2017, Kuvan net product revenues increased 17% year over year. Growth was driven by a 7% increase in the number of commercial patients on Kuvan therapy in North America resulting in 21% revenue growth in that region. For the year ended December 31, 2017, Vimizim net product revenues increased by 17% year over year, due primarily to an increase of 20% in the number of Vimizim commercial patients. Naglazyme net product revenues increased 12% year over year during the year ended December 31, 2017. The number of Naglazyme commercial patients increased 6% year over year.
As of December 31, 2017, BioMarin had cash, cash equivalents and investments totaling approximately $1.8 billion, as compared to $1.4 billion on December 31, 2016.
Commenting on the year and the quarter, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "2017 was a momentous year for BioMarin driven by numerous financial, regulatory and clinical achievements. We reduced our GAAP Net Loss and achieved our goal of Non-GAAP profitability for the full year supported by continued strong demand for our commercial products. On the regulatory front, during the first half of 2017, we received U.S. and EU approval of our sixth commercial product, Brineura, the first treatment approved for CLN2 disease. Our late-stage clinical programs all advanced as expected, including vosoritide, pegvaliase and valoctocogene roxaparvovec (formerly referred to as BMN 270). In addition to receiving PRIME and Breakthrough Therapy designations for valoctocogene roxaparvovec gene therapy for severe hemophilia A, we shared new 1.5 year results demonstrating sustained FVIII levels within the normal range. This achievement led to the start of our global GENEr8-1 and GENEr8-2 Phase 3 studies for the treatment of patients with severe hemophilia A."
Mr. Bienaimé continued, "With pegvaliase, we were pleased to have submitted our Biologics License Application in June, which was filed for review by the FDA and received a Priority Review designation. We anticipate FDA action on our Biologics License Application for pegvaliase at the end of May 2018, In addition, we plan to submit our Marketing Authorization Application for pegvaliase in Europe in the first quarter of 2018. Finally, we shared many significant updates at our R&D Day in the fourth quarter, including the announcement of our next IND candidate BMN 290 for Friedriech's ataxia, a rare neurologic disorder that affects nearly 15,000 people worldwide. We were also pleased to share that vosoritide for achondroplasia demonstrated a sustained increase in annualized growth rate at 30 months of treatment. We begin 2018 poised to move our 5 potential new product candidates to their next stage of clinical or regulatory development while driving top line revenues from our six commercialized products."
Revenues (in millions of U.S. dollars, unaudited)
------------------------------------------------
Total Revenues
Three Months Ended Twelve Months Ended
December 31,
December 31,
------------
2017 2016 $ Change % Change 2017 2016 $ Change % Change
---- ---- -------- -------- ---- ---- -------- --------
Aldurazyme $28.3 $35.0 $(6.7) (19)% $90.0 $93.8 $(3.8) (4)%
Brineura 5.2 - 5.2 n/a 8.6 - 8.6 n/a
Firdapse 4.8 4.3 0.5 12% 18.8 18.0 0.8 4%
Kuvan (1) 107.4 90.2 17.2 19% 407.5 348.0 59.5 17%
Naglazyme (2) 93.8 74.9 18.9 25% 332.2 296.5 35.7 12%
Vimizim (2) 114.0 93.8 20.2 22% 413.3 354.1 59.2 17%
----- ---- ---- ----- ----- ----
Net Product Revenues 353.5 298.2 55.3 19% 1,270.4 1,110.4 160.0 14%
Royalty and other revenues 4.8 1.9 2.9 43.2 6.5 36.7
Total revenues $358.3 $300.1 $58.2 19% $1,313.6 $1,116.9 $196.7 18%
====== ====== ===== ======== ======== ======
Kuvan revenue growth was
driven by a 7% increase in
the number of commercial
patients on Kuvan therapy in
(1) the U.S.
Naglazyme and Vimizim net
product revenues experience
quarterly fluctuations
primarily due to the timing
of government ordering
patterns in certain
(2) countries.
Details of Net Product Revenues Attributable to Aldurazyme
Three Months Ended Twelve Months Ended
December 31, December 31,
------------ ------------
2017 2016 $ Change % Change 2017 2016 $ Change % Change
---- ---- -------- -------- ---- ---- -------- --------
Aldurazyme
revenue
reported by
Genzyme $57.5 $54.8 $2.7 5% $233.8 $223.3 $10.5 5%
Three Months Ended Twelve Months Ended
December 31, December 31,
------------ ------------
2017 2016 $ Change 2017 2016 $ Change
---- ---- -------- ---- ---- --------
Revenues earned
based on Genzyme
net sales $27.9 $26.9 $1.0 $102.1 $98.1 $4.0
Net product
transfer revenues
(3) 0.4 8.1 (7.7) (12.1) (4.3) (7.8)
--- --- ---- ----- ---- ----
Total Aldurazyme
net product
revenues $28.3 $35.0 $(6.7) $90.0 $93.8 $(3.8)
===== ===== ===== ===== ===== =====
(3) To the extent units shipped to
third party customers by
Genzyme exceed BioMarin
inventory transfers to
Genzyme, BioMarin will record
a decrease in net product
revenues from the amounts
payable to BioMarin for the
amount of previously
recognized product transfer
revenue. If BioMarin
inventory transfers exceed
units shipped to third party
customers by Genzyme,
BioMarin will record
incremental net product
transfer revenues for the
period. Positive net product
transfer revenues result in
the period if BioMarin
transferred more units to
Genzyme than Genzyme sold to
third-party customers.
2018 Financial Guidance
-----------------------
Full-year Revenue Guidance ($ in millions)
Item
----
2018 Guidance
-------------
Total Revenues $1,470 to $1,530
Kuvan Net Product Revenues $440 to $480
Naglazyme Net Product Revenues $325 to $355
Vimizim Net Product Revenues $460 to $500
Brineura Net Product Revenues $35 to $55
Select Full-year Income Statement Guidance ($ in millions, except
percentages)
Item
----
2018 Guidance
-------------
Cost of Sales (% of Total
Revenues) 20.0% to 21.0%
Research and Development Expense $645 to $685
Selling, General and Admin.
Expense $575 to $615
GAAP Net Loss $(115) to $(165)
Non-GAAP Income $100 to $140
*All Financial Guidance items are calculated based on Generally Accepted Accounting Principles (GAAP) with the exception of Non-GAAP Income. Refer to Non-GAAP Information beginning on page 10 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 (formerly referred to as BMN 270) gene
therapy for hemophilia A: In December at the 2017 American Society of
Hemophilia (ASH) meeting, the Company provided new 1.5 year results
demonstrating the 6e13 vg/kg dose of valoctocogene roxaparvovec achieved
sustained factor VIII levels within the normal range in severe
hemophilia A for most patients. The data presented at ASH had a cut off
of November 16, 2017 and included a number of updates. For the 6e13
vg/kg dose, at 78 weeks post infusion, the median and mean factor VIII
levels for patients were 90 and 89%, respectively. Median annualized
bleed and factor VIII use rates for the 6e13 vg/kg cohort were zero
after week 4. Mean annualized bleed and factor VIII use rates for the
6e13 vg/kg cohort were 0.5 and 6.1, respectively. For the 4e13 vg/kg
dose, the three patients with the longest follow-up (at week 48) had
factor VIII activity levels that were in or near the normal range with
both median and mean values of 49%. Median annualized bleed and factor
VIII use rates for the 4e13 vg/kg cohort were zero after week 4 and when
their factor VIII activity rose above 5%. Mean annualized bleed and
factor VIII use rates for the 4e13vg/kg cohort were 0.6 and 2.0,
respectively. Also at ASH, the Company announced that the New England
Journal of Medicine (NEJM) published an independent, peer-reviewed
article on the ongoing Phase 1/2 study of valoctocogene roxaparvovec in
men with severe hemophilia A. The article assessed the safety and
efficacy of valoctocogene roxaparvovec at the 6e13 dose, after 52 weeks.
The NEJM article, "AAV Gene Transfer in Patients with Severe Hemophilia
A," reported sustained normalization of factor VIII activity over the
52-week period for six of seven study participants who received the 6e13
vg/kg dose of valoctocogene roxaparvovec. In addition, the article
stated that all seven participants demonstrated stabilization of
hemostasis and a profound reduction in factor VIII use. In December, the
Company announced that it had dosed the first patient in the global
GENEr8-1 Phase 3 study with the 6e13 vg/kg dose of valoctocogene
roxaparvovec for the treatment of patients with severe hemophilia A. The
global Phase 3 program includes two studies with valoctocogene
roxaparvovec, one with the 6e13 vg/kg dose (GENEr8-1) and one with the
4e13 vg/kg dose (GENEr8-2). Both Phase 3 GENEr8 studies will be
open-label single-arm studies to evaluate the efficacy and safety of
valoctocogene roxaparvovec. The Company expects to enroll the first
patient in the GENEr8-2 study in early 2018. The primary endpoint in
both studies will be based on the factor VIII activity level achieved
following valoctocogene roxaparvovec, and the secondary endpoints will
measure annualized factor VIII replacement therapy use rate and
annualized bleed rate. BioMarin also plans to begin a Phase 1/2 Study
with the 6e13kg/vg dose and with approximately 10 patients who are AAV5
positive. The first patient is expected to enroll in the first half of
2018.
-- Pegvaliase for phenylketonuria (PKU): In the second quarter of 2017,
BioMarin announced that the pegvaliase Biologics License Application
(BLA) had been filed and it remains on track for U.S. Food and Drug
Administration (FDA) action in May of 2018. In the third quarter of
2017, the Company received Priority Review designation for pegvaliase.
BioMarin plans to submit a Marketing Authorization Application (MAA) to
the European Medicines Agency in the first quarter of 2018. Pegvaliase
is a PEGylated recombinant phenylalanine ammonialyase enzyme product to
reduce blood phenylalanine (Phe) levels in adult patients with PKU who
have uncontrolled blood Phe levels on existing management.
-- Vosoritide for achondroplasia: In the fourth quarter of 2017, BioMarin
provided an update of its open-label Phase 2 study of vosoritide, an
analog of C-type Natriuretic Peptide (CNP), in children with
achondroplasia, the most common form of disproportionate short stature
in humans. Vosoritide has demonstrated sustained increase in average
growth velocity over 30 months of treatment in 10 children, who
completed 30 months of daily dosing at 15 µg/kg/day. Over this period
of time, patients experienced mean absolute growth increase of
approximately 4 cm over what their baseline growth velocity would have
predicted. The Company's multi-pronged program was developed to
demonstrate the ability to improve clinical outcomes in children with
achondroplasia. The program includes four distinct areas of focus to
support global approval. Currently enrolling, the global Phase 3 study
is a randomized, placebo-controlled study of vosoritide in approximately
110 children with achondroplasia ages 5-14 for 52 weeks. The study will
be followed by a subsequent open-label extension. Children in this study
will have completed a minimum six-month baseline study to determine
their respective baseline growth velocity prior to entering the Phase 3
study. The feeder study in the U.S. is fully enrolled and the Company
expects to complete enrollment of the Phase 3 study in mid-2018.
BioMarin expects to provide top-line data in the second half of 2019.
The long-term, open-label Phase 2 program to corroborate maintenance of
effect is anticipated to provide over 5 years of clinical data at the
time of the planned New Drug Application submission. Given the
importance of early intervention in this indication, the Company intends
to begin an infant/toddler study in 2018 in children 0-5 years old
Finally, the Company has undertaken a Natural History program to augment
clinical understanding of outcomes of untreated patients for comparison
to treated patients.
-- BMN 250 for MPS IIIB (Sanfilippo Syndrome, Type B): On February 7, 2018
at the WORLD Symposium 2018, the Company updated preliminary results
from the Phase 1/2 trial with BMN 250, an investigational enzyme
replacement therapy using a novel fusion of recombinant human
alpha-N-acetylglucosaminidase (NAGLU) with a peptide derived from
insulin-like growth factor 2 (IGF2) for the treatment of Sanfilippo B
syndrome or mucopolysaccharidosis IIIB (MPS IIIB). In 6 of 6 BMN 250
treated subjects, normalization of heparan sulfate (HS) levels, a
biomarker in the cerebrospinal fluid (CSF), was observed. Normalization
of liver size in 3 of 3 BMN 250 treated subjects was also observed.
These data suggest that BMN 250, which is administered via
intracerebroventricular (ICV) infusion, reaches peripheral circulation
and has activity in somatic organs. Development Quotient (DQ), a measure
of cognitive function normalized to age, was also observed. In 3 of 3
treated patients from the dose escalation arm of the study, preliminary
data suggest stabilization of cognitive DQ at the high dose of BMN 250
in all subjects. Patients with untreated Sanfilippo B syndrome usually
show progressive decline in DQ.Invented by BioMarin, BMN 250 is being
studied in a multicenter, international clinical trial evaluating safety
and tolerability, as well as cognitive function of patients with
Sanfilippo B receiving BMN 250. Designed to restore functional NAGLU
activity in the brain, BMN 250 is administered via
intracerebroventricular (ICV) infusion, the same delivery modality used
to treat children with Brineura.
-- BMN 290 for Friedreich's Ataxia: In the fourth quarter of 2017, BioMarin
announced that it had selected as its next drug development candidate,
BMN 290, a selective chromatin modulation therapy intended for treatment
of Friedreich's ataxia. Friedreich's ataxia is a rare autosomal
recessive disorder that results in disabling neurologic and cardiac
progressive decline. Prior to the compound being acquired by BioMarin
from Repligen Corporation (Repligen), it demonstrated increases in
frataxin in Friedreich's ataxia patients. In preclinical models, BMN 290
increases frataxin expression in brain tissues more than two-fold. The
Company selected BMN 290 for its favorable penetration into the central
nervous system and cardiac target tissues, and its preservation of the
selectivity of the original Repligen compound. Currently, there are no
approved disease modifying therapies for Friedreich's ataxia. The
Company expects to submit the IND application for BMN 290 in the second
half of 2018.
-- BioMarin sells second priority review voucher for $125.0 million: In
December 2017, the Company sold the Rare Pediatric Disease Priority
Review Voucher (PRV) it obtained in April of 2017 for a lump sum payment
of $125.0 million. The Company received the voucher under a FDA program
intended to encourage the development of treatments for rare pediatric
diseases. BioMarin was awarded the voucher when it received approval of
Brineura®, a new biological product for patients with late infantile
neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl
peptidase 1 (TPP1) deficiency, a form of Batten disease.
-- The impact of the 2017 Tax Act on the Company's 2017 provision for
income taxes: On December 22, 2017, the bill known as the Tax Cuts and
Jobs Act (the 2017 Tax Act) was signed into law, resulting in
significant changes to the U.S. corporate income tax system. These
changes include a federal statutory rate reduction from 35% to 21% and
the elimination or reduction of certain domestic deductions and credits,
including a 50% reduction in the orphan drug credit benefit. The 2017
Tax Act changed U.S. international taxation from a worldwide basis to a
modified territorial system that includes base erosion prevention
measures on foreign earnings, which will result in the Company's foreign
subsidiaries being subject to U.S. taxation in the future. These changes
are effective in 2018.The provision for income taxes was $81.2 million
for the year ended December 31, 2017 compared to a benefit from income
taxes of $200.8 million for the year ended December 31, 2016. Changes to
tax laws and tax rates are required to be accounted for in the period of
the enactment, therefore the income tax provision for the year ended
December 31, 2017 included the impact of the 2017 Tax Act. The provision
for (benefit from) income taxes for the year ended December 31, 2017
included a provisional expense of $42.3 million related to the 2017 Tax
Act, primarily consisting of $33.1 million for the re-measurement of the
net deferred tax assets at the lower enacted corporate tax rate and $9.2
million related to the new limitations on tax deductible compensation.
The Company's deferred tax assets and liabilities have been measured at
the enacted tax rate expected to apply when these temporary differences
are expected to be realized or settled. Additionally, the Company also
assessed the impact of the 2017 Tax Act on the Company's financial
projections and concluded that it is more likely than not that these
state tax credits will not be utilized in the foreseeable future, and
recognized $41.1 million of income tax expense during the fourth quarter
of 2017 to establish a valuation allowance against those state tax
credits because these credits do not expire and the Company projects
that it will be generating more credits than it will utilize on an
annual basis. The 2017 Tax Act also includes a one-time mandatory deemed
repatriation toll tax on accumulated earnings of the Company's foreign
subsidiaries that did not impact the Company, due to a net deficit in
these foreign subsidiaries.
Conference Call Details
BioMarin will host a conference call and webcast to discuss third quarter 2017 financial results today, Thursday, February 22, 2018 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: Replay International Dial-in
574.990.1362 Number: 404.537.3406
----------------------------- -----------------------------
Conference ID: 5289587 Conference ID: 5289587
---------------------- ----------------------
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 six approved products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.biomarin.com.
Forward-Looking Statement
This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: the expectations of Total Revenues, Net Product Revenues and expenses for BioMarin's commercial products, GAAP Net Loss, Non-GAAP Income (Loss) and other specified income statement guidance; the financial performance of BioMarin as a whole; the timing of BioMarin's clinical studies and trials and announcements of data from those studies and trials, including BioMarin's Phase 3 program and Phase 1/2 study with valoctocogene roxaparvovec; the ongoing Phase 2 and Phase 3 studies of vosoritide and the Phase 1/2 study of BMN 250; the continued clinical development and commercialization of BioMarin's commercial products and product candidates; including the filing of an IND for BMN 290 in the second half of 2018; the possible approval and commercialization of BioMarin's product candidates, including the filing of a Marketing Authorization Application for pegvaliase in Europe in the first quarter of 2018; the adequacy of production of valoctocogene roxaparvovec in the Company's commercial gene therapy manufacturing facility; actions by regulatory authorities, including the expected FDA action on the pegvaliase BLA at the end of May 2018 and the effect of the Tax Cuts and Jobs Act. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: BioMarin's success in the commercialization of its commercial products; Genzyme Corporation's success in continuing the commercialization of Aldurazyme; results and timing of current and planned preclinical studies and clinical trials, BioMarin's ability to successfully manufacture its commercial products and product candidates; the content and timing of decisions by the FDA, the European Commission and other regulatory authorities concerning each of the described products and product candidates; the market for each of these products; actual sales of BioMarin's commercial products; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 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(® )and Vimizim(®) are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Kyndrisa(TM) is a trademark of BioMarin Pharmaceutical Inc. Aldurazyme(®) is a registered trademark of BioMarin/Genzyme LLC.
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, 2017 and December 31, 2016
(In thousands of U.S. dollars, except share and per share amounts)
December 31, December 31,
2017 2016(1)
---- ------
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $598,028 $408,330
Short-term investments 797,940 381,347
Accounts receivable, net 261,365 215,280
Inventory 475,775 355,126
Other current assets 74,036 61,708
------ ------
Total current assets 2,207,144 1,421,791
--------- ---------
Noncurrent assets:
Long-term investments 385,785 572,711
Property, plant and equipment, net 896,700 798,768
Intangible assets, net 517,510 553,780
Goodwill 197,039 197,039
Deferred tax assets 399,095 446,786
Other assets 29,852 32,815
------ ------
Total assets $4,633,125 $4,023,690
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $401,921 $370,505
Short-term convertible debt, net 360,949 22,478
Short-term contingent acquisition consideration
payable 53,648 46,327
------ ------
Total current liabilities 816,518 439,310
Noncurrent liabilities:
Long-term convertible debt, net 813,521 660,761
Long-term contingent acquisition consideration
payable 135,318 115,310
Other long-term liabilities 59,105 42,034
------ ------
Total liabilities 1,824,462 1,257,415
--------- ---------
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 and
250,000,000 shares authorized, respectively;
175,843,749 and 172,647,588 shares issued and
outstanding, respectively. 176 173
Additional paid-in capital 4,483,220 4,288,113
Company common stock held by Nonqualified
Deferred Compensation Plan (the NQDC) (14,224) (14,321)
Accumulated other comprehensive income (loss) (22,961) 12,816
Accumulated deficit (1,637,548) (1,520,506)
---------- ----------
Total stockholders' equity 2,808,663 2,766,275
--------- ---------
Total liabilities and stockholders' equity $4,633,125 $4,023,690
========== ==========
(1) December 31, 2016 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, 2016, filed with the U.S.
Securities and Exchange
Commission on February 27, 2017.
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three and Twelve Months Ended December 31, 2017 and 2016
(In thousands of U.S. dollars, except per share amounts)
(Unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
------------ ------------
2017 2016 2017 2016
---- ---- ---- ----
REVENUES:
Net product revenues $353,577 $298,186 $1,270,445 $1,110,381
Royalty and other revenues 4,728 1,905 43,201 6,473
----- ----- ------ -----
Total revenues 358,305 300,091 1,313,646 1,116,854
------- ------- --------- ---------
OPERATING EXPENSES:
Cost of sales 75,995 64,147 241,786 209,620
Research and development 168,608 175,242 610,753 661,905
Selling, general and administrative 160,280 142,958 554,336 476,593
Intangible asset amortization and
contingent consideration 20,375 7,365 46,471 (26,953)
Impairment of intangible assets - - - 599,118
Gain on sale of intangible asset (125,000) - (125,000) -
-------- --- -------- ---
Total operating expenses 300,258 389,712 1,328,346 1,920,283
------- ------- --------- ---------
INCOME (LOSS) FROM OPERATIONS 58,047 (89,621) (14,700) (803,429)
Equity in the loss of BioMarin/
Genzyme LLC (295) (164) (1,291) (538)
Interest income 4,822 2,926 14,853 7,487
Interest expense (11,664) (9,732) (42,707) (39,499)
Other income (expense) 3,688 4,425 7,970 4,929
----- ----- ----- -----
INCOME (LOSS) BEFORE INCOME TAXES 54,598 (92,166) (35,875) (831,050)
Provision for (benefit from) income
taxes 105,990 (1,446) 81,167 (200,840)
------- ------ ------ --------
NET LOSS $(51,392) $(90,720) $(117,042) $(630,210)
======== ======== ========= =========
NET LOSS PER SHARE, BASIC $(0.29) $(0.53) $(0.67) $(3.80)
====== ====== ====== ======
NET LOSS PER SHARE, DILUTED $(0.30) $(0.53) $(0.67) $(3.81)
====== ====== ====== ======
Weighted average common shares
outstanding, basic 175,485 172,006 174,427 165,985
======= ======= ======= =======
Weighted average common shares
outstanding, diluted 175,705 172,240 174,427 166,219
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Non-GAAP Information
The results presented in this press release for the three and twelve months ended December 31, 2017 and 2016 include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income (Loss) is defined by the Company as GAAP Net Loss excluding net interest expense, provision for (benefit from) income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and certain other specified items, as detailed below. In addition, BioMarin includes in this press release the effects of these adjustments on certain components of GAAP Net Loss for each of the periods presented. In this regard, Non-GAAP income (loss) and its components, including Non-GAAP Royalty and Other Revenues, 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 Sale of Intangible Assets, and Non-GAAP Provision for (Benefit From) Income Taxes are statement of operations line items prepared on the same basis as, and therefore components of, the overall Non-GAAP measures.
BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities - the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income (Loss) and its components are important internal measurements for BioMarin, the Company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the Company's results from period to period and to its forward looking guidance, and to identify operating trends in the Company's principal business.
Non-GAAP Income (Loss) and its components are not meant to be considered in isolation, as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP measures; likewise, the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP measures. Because of the non-standardized definitions, the Non-GAAP measure as used by BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following table presents the reconciliation of GAAP Net Loss to Non-GAAP Income (Loss):
Reconciliation of GAAP Net Loss to Non-GAAP Income (Loss)
(In millions of U.S. dollars)
(unaudited)
Three Months Ended Twelve Months Ended Year Ending
December 31, December 31, December 31, 2018
------------ ------------
2017 2016 2017 2016 Guidance
---- ---- ---- ---- --------
GAAP Net Loss $(51.4) $(90.7) $(117.0) $(630.2) $(115.0) - $(165.0)
Interest expense, net 6.8 6.8 27.9 32.0 25.0 - 35.0
Provision for (benefit from)
income taxes 106.0 (1.4) 81.2 (200.8) (40.0) - 0.0
Depreciation expense 14.8 13.1 51.7 55.8 50.0 - 60.0
Amortization expense 13.4 7.6 36.2 30.2 30.0
Stock-based compensation
expense 33.6 37.3 140.2 134.6 150.0 - 170.0
Contingent consideration
expense (1) 7.0 (0.2) 10.3 (57.2) 20.0 - 30.0
Impairment charges (2) - - - 599.1 -
Gain on sale of intangible
asset (3) (125.0) - (125.0) - (20.0)
Royalty and other revenues (4) - - (31.5) - -
Non-GAAP Income
(Loss) $5.2 $(27.5) $74.0 $(36.5) $100 - $140
==== ====== ===== ====== ===========
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
(In millions of U.S. dollars)
(Unaudited)
Three Months Ended December 31,
-------------------------------
2017 2016
---- ----
Adjustments Adjustments
----------- -----------
GAAP Interest, Royalty and Non- GAAP Interest, Royalty and Non-
Taxes, Other GAAP Taxes, Other GAAP
Reported Depreciation Revenues, Reported Depreciation Revenues,
and Stock-Based and
Amortization Compensation, Amortization Stock-Based
Contingent Compensation,
Consideration Contingent
and Other Consideration
Adjustments and Other
Adjustments
Cost of sales $76.0 $ - $(2.8) $73.2 $64.1 $ - $(3.1) $61.0
Research and development 168.6 (8.0) (13.2) 147.4 175.2 (7.6) (15.3) 152.3
Selling, general and
administrative 160.3 (6.8) (17.6) 135.9 143.0 (5.5) (18.9) 118.6
Intangible asset amortization
and contingent consideration
(1) 20.4 (13.4) (7.0) - 7.4 (7.6) 0.2 -
Gain on sale of intangible
asset (3) (125.0) - 125.0 - - - -
Interest expense, net (6.8) 6.8 - - (6.8) 6.8 - -
Provision for (benefit from)
income taxes 106.0 (106.0) - - (1.4) 1.4 - -
GAAP Net Loss/Non-GAAP
Income (Loss) (51.4) 141.0 (84.4) 5.2 (90.7) 26.1 37.1 (27.5)
Twelve Months Ended December 31,
--------------------------------
2017 2016
---- ----
Adjustments Adjustments
----------- -----------
GAAP Interest, Royalty and Non- GAAP Interest, Royalty and Non-
Taxes, Other GAAP Taxes, Other GAAP
Reported Depreciation Revenues, Reported Depreciation Revenues,
and Stock-Based and Stock-Based
Amortization Compensation, Amortization Compensation,
Contingent Contingent
Consideration Consideration
and Other and Other
Adjustments Adjustments
----------- -----------
Royalty and other
revenues (4) $43.2 $ - $(31.5) $11.7 $6.5 $ - $ - $6.5
Cost of sales 241.8 - (10.6) 231.2 209.6 - (9.1) 200.5
Research and
development 610.8 (28.2) (53.1) 529.5 661.9 (31.0) (58.3) 572.6
Selling, general
and administrative 554.3 (23.5) (76.5) 454.3 476.6 (24.8) (67.2) 384.6
Intangible asset
amortization and
contingent
consideration (1) 46.5 (36.2) (10.3) - (27.0) (30.2) 57.2 -
Impairment of
intangible assets
(2) - - - - 599.1 - (599.1) -
Gain on sale of
intangible asset
(3) (125.0) - 125.0 - - - - -
Interest expense,
net (27.9) 27.9 - - (32.0) 32.0 - -
Provision for
(benefit from)
income taxes 81.2 (81.2) - - (200.8) 200.8 - -
GAAP Net Loss/Non-
GAAP Income (Loss) (117.0) 197.0 (6.0) 74.0 (630.2) (82.8) 676.5 (36.5)
1. Amounts include the expense associated
with the change in the fair value of
contingent acquisition consideration
payable for the period, resulting from
changes in estimated probabilities and
timing of achieving certain regulatory
and commercial milestones. Amounts for
the year ended December 31, 2016 include
$43.8 million and $21.1 million related
to the change in probability of
achieving the Kyndrisa and
reveglucosidase alfa development
milestones, respectively, as a result of
discontinuance of these programs in June
2016.
2. Amounts for the twelve months ended
December 31, 2016 include $574.1 million
and $25.0 million for the impairment of
intangible assets associated with the
discontinuance of the Kyndrisa and
Reveglucosidase alpha development
programs, respectively.
3. Amount represents gain on the sale of the
Priority Review Voucher in December
2017.
Primarily represents the one-time
upfront payment related to the License
and Settlement Agreement entered into
with Sarepta Therapeutics, Inc. in July
4. 2017.
Contact:
Investors: Media:
Traci McCarty Debra Charlesworth
BioMarin Pharmaceutical Inc. BioMarin Pharmaceutical Inc.
(415) 455-7558 (415) 455-7451
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SOURCE BioMarin Pharmaceutical Inc.
