Total FY'23 Revenues of $2.42 Billion (+15% Y/Y and +20% Y/Y at Constant
Currency); GAAP Diluted Earnings per Share of $0.87 (+16% Y/Y) and Non-GAAP Diluted Earnings
per Share of $2.08 (+36% Y/Y)
VOXZOGO® Net Revenues of $146 Million in Q4'23 (+118% Q/Q) and
$470 Million for FY'23 (+178%
Y/Y)
BioMarin's 2024 Financial Outlook Reflects
Anticipated Double-digit Total Revenue Growth, Significant Non-GAAP
Operating Margin Expansion, and Non-GAAP Earnings Per Share Growing
Faster than Revenues
Conference Call and Webcast Scheduled Today at
4:30 p.m. ET
SAN
RAFAEL, Calif., Feb. 22,
2024 /PRNewswire/ -- BioMarin Pharmaceutical
Inc. (NASDAQ: BMRN) today announced financial results for the
fourth quarter and full year ended December 31, 2023.
"Strong financial results in 2023 were driven by global demand
for VOXZOGO, the only approved treatment for children with
achondroplasia, and contributions from our established enzyme
products. VOXZOGO revenues grew 18% over the prior quarter and were
positively impacted by an increase in prescriptions for children in
the United States under the age of
5, following the Food and Drug Administration's (FDA) October
approval of VOXZOGO for children of all ages with open growth
plates," said Alexander Hardy,
President and Chief Executive Officer of BioMarin. "Looking ahead
in 2024, our full-year financial guidance reflects our focus on
value creation through achievement of four strategic priorities
outlined earlier this year. We intend to maximize the VOXZOGO
opportunity, continue to build-out global access channels for
ROCTAVIAN, judiciously prioritize the most potentially impactful
R&D candidates, and drive operational excellence and cost
optimization with the goal of delivering growth, efficiency and
profitability."
Financial Highlights
(in millions of U.S. dollars, except per share data,
unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2023
|
|
2022
|
|
%
Change
|
|
2023
|
|
2022
|
|
%
Change
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
Revenues
|
$
646.2
|
|
$
537.5
|
|
20 %
|
|
$ 2,419.2
|
|
$ 2,096.0
|
|
15 %
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Enzyme Product
Revenues (1)
|
$
448.0
|
|
$
405.1
|
|
11 %
|
|
$ 1,718.3
|
|
$ 1,645.3
|
|
4 %
|
|
|
|
|
|
|
|
|
|
|
|
|
VIMIZIM® Net
Product Revenues
|
$
175.6
|
|
$
152.1
|
|
15 %
|
|
$
701.0
|
|
$
663.8
|
|
6 %
|
VOXZOGO Net Product
Revenues
|
$
145.7
|
|
$
66.8
|
|
118 %
|
|
$
469.9
|
|
$
169.1
|
|
178 %
|
NAGLAZYME®
Net Product Revenues
|
$
98.3
|
|
$
100.5
|
|
(2) %
|
|
$
420.3
|
|
$
443.8
|
|
(5) %
|
PALYNZIQ®
Net Product Revenues
|
$
87.8
|
|
$
72.3
|
|
21 %
|
|
$
303.9
|
|
$
255.0
|
|
19 %
|
BRINEURA®
Net Product Revenues
|
$
43.6
|
|
$
42.6
|
|
2 %
|
|
$
161.9
|
|
$
154.3
|
|
5 %
|
ALDURAZYME®
Net Product Revenues
|
$
42.7
|
|
$
37.6
|
|
14 %
|
|
$
131.2
|
|
$
128.4
|
|
2 %
|
KUVAN® Net
Product Revenues
|
$
36.7
|
|
$
53.6
|
|
(32) %
|
|
$
180.8
|
|
$
227.6
|
|
(21) %
|
ROCTAVIAN Net Product
Revenues
|
$
2.7
|
|
$
—
|
|
nm
|
|
$
3.5
|
|
$
—
|
|
nm
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net Income (Loss)
(2)
|
$
20.4
|
|
$
(0.2)
|
|
|
|
$
167.6
|
|
$
141.6
|
|
|
Non-GAAP Income
(3)
|
$
94.9
|
|
$
63.1
|
|
|
|
$
405.4
|
|
$
290.8
|
|
|
GAAP Diluted Earnings
(Loss) per Share (EPS)
|
$
0.11
|
|
$
(0.00)
|
|
|
|
$
0.87
|
|
$
0.75
|
|
|
Non-GAAP Diluted EPS
(4)
|
$
0.49
|
|
$
0.33
|
|
|
|
$
2.08
|
|
$
1.53
|
|
|
|
December 31,
2023
|
|
December 31,
2022
|
Total cash, cash
equivalents & investments
|
$
1,684.9
|
|
$
1,625.4
|
(1)
|
Enzyme Products
include ALDURAZYME, BRINEURA, NAGLAZYME, PALYNZIQ, and
VIMIZIM.
|
|
|
(2)
|
GAAP Net Income in the
twelve months ended December 31, 2022 included a $89.0 million
gain, net of taxes, related to the sale of the Rare Pediatric
Disease Priority Review Voucher (PRV) the company received from the
U.S. Food and Drug Administration (FDA) in connection with U.S.
approval of VOXZOGO.
|
|
|
(3)
|
Non-GAAP Income is
defined by the company as reported GAAP Net Income (Loss),
excluding amortization expense, stock-based compensation expense,
contingent consideration, and, in certain periods, certain other
specified items. The company also includes a Non-GAAP adjustment
for the estimated income tax impact of reconciling items. Refer to
Non-GAAP Information beginning on page 9 of this press
release for a complete discussion of the company's Non-GAAP
financial information and reconciliations to the comparable
information reported under U.S. GAAP.
|
|
|
(4)
|
Non-GAAP Diluted EPS is
defined by the company as Non-GAAP Income divided by Non-GAAP
diluted weighted-average shares outstanding. Non-GAAP
weighted-average diluted shares outstanding is defined by the
company as GAAP weighted-average diluted shares outstanding,
adjusted to include any common shares issuable under the company's
equity plans and convertible debt in periods when they are dilutive
under Non-GAAP.
|
|
|
nm
|
Not
meaningful
|
Financial Highlights:
- Total Revenues for the fourth quarter of 2023 were
$646.2 million, an increase of 20%
compared to the same period in 2022. The increase in Total Revenues
was primarily attributed to higher VOXZOGO sales volume driven by
new patients initiating therapy across all regions, which included
a significant number of new patient starts in the U.S. for children
under the age of 5 years. The increase was also due to higher
VIMIZIM product revenues primarily driven by the timing of large
government orders. This was partially offset by lower KUVAN product
revenues attributed to continued generic competition as a result of
the loss of market exclusivity.
- GAAP Net Income increased by $20.6 million to $20.4 million in the fourth quarter of 2023
compared to the same period in 2022. The increase was primarily due
to higher gross profit driven by increased revenues and reduced
severance costs associated with the company's organizational
redesign announced in the fourth quarter of 2022. This was
partially offset by higher spend in research and development
(R&D) programs to support both early-stage research and
clinical activities and higher selling, general and administrative
(SG&A) expenses related to an asset impairment charge,
corporate governance and leadership transition costs, costs to
support the commercial launch of ROCTAVIAN as well as a decrease in
income tax benefits and an investment loss.
- Non-GAAP Income increased by $31.8 million to $94.9
million in the fourth quarter of 2023 compared to the same
period in 2022. The increased Non-GAAP Income was primarily due to
higher gross profit driven by increased revenues, partially offset
by higher R&D expenses for the same reasons noted above, higher
SG&A expenses related to corporate governance and leadership
transitions and ROCTAVIAN commercial launch costs as well as an
increase in income tax expense.
2024 Strategic Priorities
In January, BioMarin management outlined key priorities focused
on value creation through accelerating growth, optimizing
efficiencies and driving operational excellence. For 2024, the
company plans to provide material updates across the business, both
scientific and financial, according to these strategic
priorities:
Accelerate and maximize the VOXZOGO opportunity
- In the fourth quarter, the FDA approved VOXZOGO for children
under 5 years of age. Approximately 70% of new U.S. treatment
starts in the fourth quarter were from that age group following the
age label expansion approval in October
2023. With VOXZOGO now approved for younger children in key
large markets, product expansion is expected to accelerate across
younger age groups throughout 2024.
- The number of children with achondroplasia being treated with
VOXZOGO increased 128% in 2023 compared to the end of 2022.
As of December 31, 2023, 2,613
children with achondroplasia were being treated with VOXZOGO across
41 active markets, compared to 1,150 children on therapy at the end
of 2022.
- In the fourth quarter, BioMarin began the pivotal program with
VOXZOGO for the treatment of children with hypochondroplasia. The
6-month run-in study will be followed by the 52-week randomized,
double-blind, placebo-controlled phase of the 80-participant
clinical trial, with the treatment study expected to begin
mid-2024.
- BioMarin is engaging global health authorities in the first
half of this year regarding development programs in idiopathic
short stature and multiple genetic short stature pathway
conditions, with plans to begin pivotal studies later this
year.
Establish ROCTAVIAN opportunity
- As an important new treatment option for those with severe
hemophilia A, BioMarin expects continued progress increasing
ROCTAVIAN access and patients treated in 2024. This year,
BioMarin's commercial team will continue to focus on key elements
critical to supporting the uptake of ROCTAVIAN including, clinical
eligibility, site readiness and patient and physician
education.
- In January, the Italian Medicines Agency approved reimbursement
for ROCTAVIAN in severe hemophilia A.
- In 2023, three patients were treated with ROCTAVIAN, two in
Germany and one in the U.S.
Focus R&D on the most productive assets
- During the first quarter of 2024, BioMarin began a strategic
portfolio review of all R&D programs to determine which meet
the criteria for further investment and advancement. A complete
update on prioritized R&D assets, those with the highest
potential patient impact and highest potential value creation for
shareholders, will be communicated at our Investor Day later in
2024.
Accelerate EPS growth and expand margins
- BioMarin's 2024 financial outlook reflects anticipated
year-over-year double-digit Total Revenue growth, reduced operating
expenses as a percentage of revenue, acceleration of Non-GAAP
Operating Margin expansion and Non-GAAP Earnings Per Share growing
faster than revenue.
2024 Full-Year Financial Guidance
BioMarin does not provide guidance for GAAP reported financial
measures (other than revenue) or a reconciliation of
forward-looking Non-GAAP financial measures to the most directly
comparable GAAP reported financial measures because the company is
unable to predict with reasonable certainty the financial impact of
changes resulting from our strategic portfolio and business
operating model reviews; potential future asset impairments; gains
and losses on investments; and other unusual gains and losses
without unreasonable effort. These items are uncertain, depend on
various factors, and could have a material impact on GAAP reported
results for the guidance period. As such, any reconciliations
provided would imply a degree of precision that could be confusing
or misleading to investors.
Item
|
|
2024 Guidance (in
millions, except % and EPS amounts)
|
Total
Revenues
|
|
$2,700
|
|
to
|
|
$2,800
|
Non-GAAP Operating
Margin % (1)
|
|
23 %
|
|
to
|
|
24 %
|
Non-GAAP Diluted EPS
(2)
|
|
$2.60
|
|
to
|
|
$2.80
|
|
|
(1)
|
Non-GAAP Operating
Margin percentage is defined by the company as GAAP Income from
Operations, excluding amortization of intangible assets, stock
based compensation expense and certain specified items divided by
Total Revenues.
|
|
|
(2)
|
Non-GAAP Diluted EPS
guidance assumes approximately 200 million weighted-average diluted
shares outstanding.
|
BioMarin will host a conference call and webcast to discuss
fourth quarter and full year 2023 financial results and full-year
2024 financial guidance today, Thursday, February 22, 2024, at
4:30 p.m. ET. This event can be
accessed through this link or on the investor section of the
BioMarin website at www.biomarin.com.
U.S./Canada Dial-in
Number: 888-330-3073
|
Replay Dial-in Number:
800-770-2030
|
International Dial-in
Number: 646-960-0683
|
Replay International
Dial-in Number: 647-362-9199
|
No Conference ID:
1816377
|
Conference ID:
1816377
|
About BioMarin
Founded in 1997, BioMarin is a global biotechnology company
dedicated to transforming lives through genetic discovery. The
company develops and commercializes targeted therapies that address
the root cause of genetic conditions. BioMarin's robust research
and development capabilities have resulted in multiple innovative
commercial therapies for patients with rare genetic disorders. The
company's distinctive approach to drug discovery has produced a
diverse pipeline of commercial, clinical, and pre-clinical
candidates that address a significant unmet medical need, have
well-understood biology, and provide an opportunity to be
first-to-market or offer a substantial benefit over existing
treatment options. For additional information, please visit
www.biomarin.com.
Forward-Looking Statements
This press release and the associated conference call and
webcast contain forward-looking statements about the business
prospects of BioMarin Pharmaceutical Inc. (BioMarin), including,
without limitation, statements about: the expectations of Total
Revenues, Non-GAAP Operating Margin percentage, and Non-GAAP
Diluted EPS for the full-year 2024; cash flows from operating
activities; BioMarin's plans to reduce operating expenses and
expand margins; BioMarin's focus on its strategic priorities and
the anticipated benefits from the same; the timing of orders for
commercial products; the timing of BioMarin's clinical development
and commercial prospects, including announcements of data from
clinical studies and trials; the clinical development and
commercialization of BioMarin's product candidates and commercial
products, including (i) the potential to leverage VOXZOGO in
conditions beyond achondroplasia, such as hypochondroplasia as well
as idiopathic short stature and other genetic short stature pathway
conditions, and (ii) the product expansion opportunities for
ROCTAVIAN, including results from any related clinical studies; the
commercialization of BioMarin's products, including (i) the
anticipated start and growth of commercial sales of VOXZOGO in
additional countries, and (ii) the commercialization of ROCTAVIAN
for the treatment of severe hemophilia A in the U.S. and
Europe; the expected benefits and
availability of BioMarin's product candidates; and potential growth
opportunities and trends, including that BioMarin expects
accelerated growth of VOXZOGO revenues as the product launch
continues in future quarters and that BioMarin expects growth of
ROCTAVIAN revenues as the product's access is expanded in
Europe and the U.S.
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, impacts of macroeconomic and other
external factors on BioMarin's operations; results and timing of
current and planned preclinical studies and clinical trials and the
release of data from those trials; BioMarin's ability to
successfully manufacture its commercial products and product
candidates; the content and timing of decisions by the FDA, the
European Commission and other regulatory authorities concerning
each of the described products and product candidates; the market
for each of these products; actual sales of BioMarin's commercial
products; the introduction of generic versions of BioMarin's
commercial products, in particular generic versions of KUVAN; and
those factors detailed in BioMarin's filings with the Securities
and Exchange Commission (SEC), including, without limitation, the
factors contained under the caption "Risk Factors" in BioMarin's
Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 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®, KUVAN®,
NAGLAZYME®, PALYNZIQ®, VIMIZIM®
and VOXZOGO® are registered trademarks of BioMarin
Pharmaceutical Inc., or its affiliates. ROCTAVIAN® is a
trademark of BioMarin Pharmaceutical Inc., with registration in
Europe and pending in the U.S.
ALDURAZYME® is a registered trademark of
BioMarin/Genzyme LLC. All other brand names and service marks,
trademarks and other trade names appearing in this release are the
property of their respective owners.
Contact:
|
|
|
Investors:
|
|
Media:
|
Traci McCarty
|
|
Marni Kottle
|
BioMarin Pharmaceutical Inc.
|
|
BioMarin Pharmaceutical Inc.
|
(415) 455-7558
|
|
(650) 374-2803
|
BIOMARIN
PHARMACEUTICAL INC.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
December 31,
2023 and December 31, 2022
|
(In thousands of
U.S. dollars, except per share amounts)
|
|
|
December 31,
2023
|
|
December 31, 2022
⁽¹⁾
|
ASSETS
|
(unaudited)
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
755,127
|
|
$
724,531
|
Short-term
investments
|
318,683
|
|
567,006
|
Accounts receivable,
net
|
633,704
|
|
461,316
|
Inventory
|
1,107,183
|
|
894,083
|
Other current
assets
|
141,391
|
|
104,521
|
Total current
assets
|
2,956,088
|
|
2,751,457
|
Noncurrent
assets:
|
|
|
|
Long-term
investments
|
611,135
|
|
333,835
|
Property, plant and
equipment, net
|
1,066,133
|
|
1,073,366
|
Intangible assets,
net
|
294,701
|
|
338,569
|
Goodwill
|
196,199
|
|
196,199
|
Deferred tax
assets
|
1,545,809
|
|
1,505,412
|
Other
assets
|
171,538
|
|
176,236
|
Total
assets
|
$
6,841,603
|
|
$
6,375,074
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts payable and
accrued liabilities
|
$
683,147
|
|
$
572,959
|
Short-term convertible
debt, net
|
493,877
|
|
—
|
Short-term contingent
consideration
|
—
|
|
15,925
|
Total current
liabilities
|
1,177,024
|
|
588,884
|
Noncurrent
liabilities:
|
|
|
|
Long-term convertible
debt, net
|
593,095
|
|
1,083,019
|
Other long-term
liabilities
|
119,935
|
|
100,015
|
Total
liabilities
|
1,890,054
|
|
1,771,918
|
Stockholders'
equity:
|
|
|
|
Common stock, $0.001
par value: 500,000,000 shares authorized; 188,598,154 and
186,250,719 shares issued and outstanding, respectively
|
189
|
|
186
|
Additional paid-in
capital
|
5,611,562
|
|
5,404,895
|
Company common stock
held by the Nonqualified Deferred Compensation Plan
|
(9,860)
|
|
(8,859)
|
Accumulated other
comprehensive loss
|
(28,788)
|
|
(3,867)
|
Accumulated
deficit
|
(621,554)
|
|
(789,199)
|
Total stockholders'
equity
|
4,951,549
|
|
4,603,156
|
Total liabilities and
stockholders' equity
|
$
6,841,603
|
|
$
6,375,074
|
|
|
|
|
(1)
|
December 31, 2022
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, 2022, filed with the U.S. Securities
and Exchange Commission (SEC) on February 27, 2023.
|
BIOMARIN PHARMACEUTICAL
INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
Three and Twelve
Months Ended December 31, 2023 and 2022
|
(In thousands of
U.S. dollars, except per share amounts)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
|
REVENUES:
|
|
|
|
|
|
|
|
Net product
revenues
|
$
633,148
|
|
$
525,492
|
|
$
2,372,538
|
|
$
2,042,025
|
Royalty and other
revenues
|
13,059
|
|
12,046
|
|
46,688
|
|
54,014
|
Total
revenues
|
646,207
|
|
537,538
|
|
2,419,226
|
|
2,096,039
|
OPERATING
EXPENSES:
|
|
|
|
|
|
|
|
Cost of
sales
|
135,478
|
|
127,290
|
|
514,854
|
|
483,669
|
Research and
development
|
206,250
|
|
172,751
|
|
746,773
|
|
649,606
|
Selling, general and
administrative
|
275,024
|
|
245,739
|
|
937,291
|
|
854,009
|
Intangible asset
amortization and contingent consideration
|
15,236
|
|
16,258
|
|
62,211
|
|
67,193
|
Gain on sale of
nonfinancial assets, net
|
—
|
|
—
|
|
—
|
|
(108,000)
|
Total operating
expenses
|
631,988
|
|
562,038
|
|
2,261,129
|
|
1,946,477
|
INCOME (LOSS) FROM
OPERATIONS
|
14,219
|
|
(24,500)
|
|
158,097
|
|
149,562
|
|
|
|
|
|
|
|
|
Interest
income
|
18,044
|
|
8,710
|
|
58,339
|
|
18,034
|
Interest
expense
|
(6,098)
|
|
(3,626)
|
|
(17,335)
|
|
(15,970)
|
Other income (expense),
net
|
(6,838)
|
|
1,858
|
|
(10,538)
|
|
(2,050)
|
INCOME (LOSS) BEFORE
INCOME TAXES
|
19,327
|
|
(17,558)
|
|
188,563
|
|
149,576
|
Provision for (benefit
from) income taxes
|
(1,048)
|
|
(17,309)
|
|
20,918
|
|
8,015
|
NET INCOME
(LOSS)
|
$
20,375
|
|
$
(249)
|
|
$
167,645
|
|
$
141,561
|
EARNINGS (LOSS) PER
SHARE, BASIC
|
$
0.11
|
|
$
(0.00)
|
|
$
0.89
|
|
$
0.76
|
EARNINGS (LOSS) PER
SHARE, DILUTED
|
$
0.11
|
|
$
(0.00)
|
|
$
0.87
|
|
$
0.75
|
Weighted average common
shares outstanding, basic
|
188,479
|
|
186,028
|
|
187,834
|
|
185,266
|
Weighted average common
shares outstanding, diluted
|
191,838
|
|
186,028
|
|
191,595
|
|
188,963
|
BIOMARIN
PHARMACEUTICAL INC.
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
Twelve Months Ended
December 31, 2023 and 2022
|
(In thousands of
U.S. dollars)
|
|
|
Twelve Months Ended
December 31,
|
|
2023
|
|
2022
|
|
(unaudited)
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
|
Net income
|
$
167,645
|
|
$
141,561
|
Adjustments to
reconcile net income to net cash used in operating
activities:
|
|
|
|
Depreciation and
amortization
|
104,386
|
|
101,969
|
Non-cash interest
expense
|
4,188
|
|
4,117
|
Amortization of
premium (accretion of discount) on investments
|
(9,228)
|
|
3,043
|
Stock-based
compensation
|
207,099
|
|
196,308
|
Gain on sale of
nonfinancial assets, net
|
—
|
|
(108,000)
|
Impairment of
assets
|
38,608
|
|
—
|
Deferred income
taxes
|
(44,981)
|
|
(52,087)
|
Unrealized foreign
exchange loss (gain)
|
28,446
|
|
(14,287)
|
Non-cash changes in
the fair value of contingent consideration
|
—
|
|
1,704
|
Other
|
(365)
|
|
(2,043)
|
Changes in operating
assets and liabilities:
|
|
|
|
Accounts receivable,
net
|
(190,435)
|
|
(82,033)
|
Inventory
|
(157,058)
|
|
(68,264)
|
Other current
assets
|
(50,335)
|
|
7,822
|
Other
assets
|
(31,149)
|
|
(19,859)
|
Accounts payable and
other short-term liabilities
|
68,853
|
|
59,018
|
Other long-term
liabilities
|
23,585
|
|
6,933
|
Net cash provided by
operating activities
|
159,259
|
|
175,902
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
|
Purchases of property,
plant and equipment
|
(96,691)
|
|
(120,959)
|
Maturities and sales of
investments
|
864,863
|
|
619,995
|
Purchases of
investments
|
(868,496)
|
|
(611,809)
|
Proceeds from sale of
nonfinancial assets
|
—
|
|
103,325
|
Purchase of intangible
assets
|
(10,920)
|
|
(10,581)
|
Net cash used in
investing activities
|
(111,244)
|
|
(20,029)
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
|
Proceeds from exercises
of awards under equity incentive plans
|
69,353
|
|
69,333
|
Taxes paid related to
net share settlement of equity awards
|
(76,319)
|
|
(54,283)
|
Payments of contingent
consideration
|
(9,475)
|
|
(31,095)
|
Principal repayments of
financing leases
|
(2,286)
|
|
(2,605)
|
Net cash used in
financing activities
|
(18,727)
|
|
(18,650)
|
Effect of exchange
rate changes on cash
|
1,308
|
|
32
|
NET INCREASE IN CASH
AND CASH EQUIVALENTS
|
30,596
|
|
137,255
|
Cash and cash
equivalents:
|
|
|
|
Beginning of
period
|
$
724,531
|
|
$
587,276
|
End of
period
|
$
755,127
|
|
$
724,531
|
Non-GAAP Information
The results presented in this press release include both GAAP
information and Non-GAAP information. Non-GAAP Income is defined by
the company as GAAP Net Income (Loss) excluding amortization of
intangible assets, stock-based compensation expense, contingent
consideration expense, and, in certain periods, certain other
specified items, as detailed below when applicable. Non-GAAP
Operating Margin percentage is defined by the company as GAAP
Income from Operations, excluding amortization of intangible
assets, stock based compensation expense, contingent consideration
expense, and, in certain periods, certain other specified items,
divided by Total Revenues. The company also includes a Non-GAAP
adjustment for the estimated tax impact of the reconciling items.
Non-GAAP Diluted EPS is defined by the company as Non-GAAP Income
divided by Non-GAAP diluted shares outstanding. The company's
presentation of percentage changes in total revenues at constant
currency rates, which is computed using current period local
currency sales at the prior period's foreign exchange rates, is
also a Non-GAAP financial measure. This measure provides
information about growth (or declines) in the company's total
revenue as if foreign currency exchange rates had not changed
between the prior period and the current period.
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, Non-GAAP Operating Margin percentage,
Non-GAAP Diluted EPS, Non-GAAP Diluted Shares and constant currency
are important internal measurements for BioMarin, the company
believes that providing this information in conjunction with
BioMarin's GAAP information enhances investors' and analysts'
ability to meaningfully compare the company's results from period
to period and to its forward-looking guidance, and to identify
operating trends in the company's principal business. BioMarin also
uses Non-GAAP Income internally to understand, manage and evaluate
its business and to make operating decisions, and compensation of
executives is based in part on this measure.
Non-GAAP Income and its components are not meant to be
considered in isolation or 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 financial
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 financial
measures; likewise, the company may in the future cease to exclude
items that it has historically excluded for purposes of its
Non-GAAP financial measures. Because of the non-standardized
definitions, the Non-GAAP financial 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 tables present the reconciliation of GAAP reported
to Non-GAAP adjusted financial information:
Reconciliation of
GAAP Reported Net Income (Loss) to Non-GAAP
Income(1)
|
(In millions of U.S.
dollars)
|
(unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
GAAP Reported Net
Income (Loss)
|
$
20.4
|
|
$
(0.2)
|
|
$
167.6
|
|
$
141.6
|
Adjustments
|
|
|
|
|
|
|
|
Stock-based
compensation expense - COS
|
4.5
|
|
4.3
|
|
17.6
|
|
17.7
|
Stock-based
compensation expense - R&D
|
16.3
|
|
13.8
|
|
65.7
|
|
61.7
|
Stock-based
compensation expense - SG&A
|
34.0
|
|
28.7
|
|
123.8
|
|
116.9
|
Amortization of
intangible assets
|
15.2
|
|
15.7
|
|
62.2
|
|
62.8
|
Contingent
consideration
|
—
|
|
0.6
|
|
—
|
|
4.4
|
Gain on sale of
non-financial assets (2)
|
—
|
|
—
|
|
—
|
|
(108.0)
|
Severance and employee
termination benefits (3)
|
—
|
|
18.2
|
|
(0.5)
|
|
23.0
|
Asset impairments
(4)
|
14.0
|
|
—
|
|
14.0
|
|
—
|
Loss on investments
(5)
|
11.9
|
|
—
|
|
24.5
|
|
—
|
Income tax effect of
adjustments
|
(21.4)
|
|
(18.0)
|
|
(69.5)
|
|
(29.3)
|
Non-GAAP
Income
|
$
94.9
|
|
$
63.1
|
|
$
405.4
|
|
$
290.8
|
Reconciliation of
Certain GAAP Reported Information to Non-GAAP
Information(1)
|
(in millions, except
per share data)
|
(unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
GAAP Diluted
EPS
|
$
0.11
|
|
$
(0.00)
|
|
$
0.87
|
|
$
0.75
|
Adjustments
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
0.27
|
|
0.24
|
|
1.04
|
|
1.02
|
Amortization of
intangible assets
|
0.08
|
|
0.08
|
|
0.31
|
|
0.33
|
Contingent
consideration
|
—
|
|
—
|
|
—
|
|
0.02
|
Gain on sale of
non-financial assets (2)
|
—
|
|
—
|
|
—
|
|
(0.56)
|
Severance and employee
termination benefits (3)
|
—
|
|
0.09
|
|
—
|
|
0.12
|
Asset impairments
(4)
|
0.07
|
|
—
|
|
0.07
|
|
—
|
Loss on investments
(5)
|
0.06
|
|
—
|
|
0.12
|
|
—
|
Income tax effect of
adjustments
|
(0.10)
|
|
(0.09)
|
|
(0.33)
|
|
(0.15)
|
Non-GAAP Diluted
EPS
|
$
0.49
|
|
$
0.33
|
|
$
2.08
|
|
$
1.53
|
|
|
(1)
|
Certain amounts may not
sum or recalculate due to rounding.
|
|
|
(2)
|
Represents the net gain
in the first quarter of 2022 on the sale to a third party of
the PRV the company received from the FDA in connection with
the U.S. approval of VOXZOGO.
|
|
|
(3)
|
Represents severance
and employee termination benefit charges and subsequent adjustments
included in SG&A related to the company's organizational
redesign announced in the fourth quarter of 2022.
|
|
|
(4)
|
Represents the
write-off of capitalized tooling and fixed assets in SG&A
associated with the company's decision to cease development of the
first generation VOXZOGO pen device in the fourth quarter of
2023.
|
|
|
(5)
|
Represents the
impairment losses on an investment in non-marketable equity
securities and a convertible note recorded in Other income
(expense), net in the first and fourth quarter of 2023,
respectively.
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
|
|
|
|
|
GAAP
Weighted-Average Dilutive Shares Outstanding
|
191.8
|
|
186.0
|
|
191.6
|
|
189.0
|
Adjustments
|
|
|
|
|
|
|
|
Common stock issuable
under the company's equity plans
|
—
|
|
4.1
|
|
—
|
|
—
|
Common stock issuable
under company's convertible debt (1)
|
8.4
|
|
4.0
|
|
8.4
|
|
4.0
|
Non-GAAP
Weighted-Average Dilutive Shares Outstanding
|
200.2
|
|
194.1
|
|
200.0
|
|
193.0
|
|
|
(1)
|
Common
stock issuable under the company's convertible debt was
excluded from the computation of GAAP Weighted-Average Dilutive
Shares Outstanding when they were anti-dilutive. If converted, the
company would issue 4.0 million shares under the convertible notes
due in 2024 and 4.4 million shares under the convertible notes due
in 2027.
|
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SOURCE BioMarin Pharmaceutical Inc.