BioMarin Announces First Quarter 2020 Total Revenue Growth of 25% to $502 million
SAN RAFAEL, Calif., April 29, 2020 /PRNewswire/ --
Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)
Three Months Ended March 31,
2020 2019 % Change
Total Revenues $
502.1 $
400.7 25
%
Net Product
Revenues %
Marketed by
BioMarin (1) 433.3 349.2 24
Vimizim Net
Product %
Revenues 137.2 125.8 9
Kuvan Net
Product %
Revenues 122.0 106.9 14
Naglazyme Net
Product %
Revenues 114.3 86.9 32
Palynziq Net
Product %
Revenues 34.6 12.3 181
Brineura Net
Product %
Revenues 24.0 12.2 97
Aldurazyme Net
Product %
Revenues 55.7 45.3 23
GAAP Net Income
(Loss) $
81.4 $
(56.5)
GAAP Net Income
(Loss) per
Share - Basic $
0.45 $
(0.32)
GAAP Net Income
(Loss) per
Share -
Diluted $
0.44 $
(0.32)
Non-GAAP
Income (2) $
116.5 $
24.8
March 31, December 31,
2020 2019
Cash, cash equivalents and
investments $
1,149.2 $
1,165.8
(1) Net Product Revenues Marketed by
BioMarin is the sum of revenues
from Vimizim, Kuvan, Naglazyme,
Palynziq, Brineura and Firdapse,
each calculated in accordance with
Generally Accepted Accounting
Principles in the United States
(U.S. GAAP). Sanofi Genzyme
(Genzyme) is BioMarin's sole
customer for Aldurazyme and is
responsible for marketing and
selling Aldurazyme to third
parties. Refer to page 9 for a
table showing Net Product Revenues
by product, including Firdapse. In
January 2020, BioMarin divested
the Firdapse assets to a third
party in a sale transaction. The
sale will be reflected in the
Company's consolidated financial
statements for the three months
ending March 31, 2020; as a result
of the transaction BioMarin will
not recognize Net Product Revenues
from Firdapse in the future.
(2) Non-GAAP Income is defined by the
Company as reported GAAP Net
Income, excluding net interest
expense, provision for (benefit
from) income taxes, depreciation
expense, amortization expense,
stock-based compensation expense,
contingent consideration expense
and, in certain periods, certain
other specified items. Refer to
Non-GAAP Information beginning on
page 10 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.
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) today announced financial results for the first quarter ended March 31, 2020.
Total Revenues increased 25% to $502.1 million. The increase in Total Revenues was primarily attributed to increased Net Product Revenues which were $489.0 million in the first quarter of 2020, compared to $394.5 million for the first quarter of 2019. The increase in Net Product Revenues was attributed to the following:
-- Naglazyme Net Product Revenues increased by $27.4 million, or 32%,
primarily due to orders from Russia and Brazil;
-- Palynziq Net Product Revenues increased by $22.3 million or 181%, driven
by combination of revenue from U.S. patients achieving maintenance
dosing and new patients initiating therapy;
-- Kuvan Net Product Revenues increased by $15.1 million, or 14%, primarily
driven by patient growth in North America;
-- Brineura Net Product Revenues increased by $11.8 million, or 97%, due in
large part to global patient growth;
-- Vimizim Net Product Revenues increased by $11.4 million, or 9%, driven
primarily due to orders from Brazil; and
-- Aldurazyme Net Product Revenues increased $10.4 million, or 23%, due to
higher sales volume to Sanofi Genzyme.
The increase in GAAP Net Income for the first quarter of 2020, compared to GAAP Net Loss for the same period in 2019 was primarily due to the following:
-- increased gross profits of $79.1 million primarily driven by increased
product sales;
-- a net gain on the sale of nonfinancial assets of $59.5 million due to
the divestiture and sale of the Firdapse business; and
-- decreased research and development (R&D) expenses; partially offset by
-- higher selling, general and administrative (SG&A) expense related to
pre-commercialization activities for valoctocogene roxaparvovec,
commercialization activities in support of the EU commercial launch and
continued U.S. expansion of Palynziq, and foreign currency exchange
losses.
Non-GAAP Income for the first quarter of 2020 increased to $116.5 million, compared to Non-GAAP Income of $24.8 million for the same period in 2019. The increase in Non-GAAP Income for the quarter, compared to the same period in 2019, was attributed to higher gross profit and decreased R&D expense, partially offset by higher SG&A expense.
As of March 31, 2020, BioMarin had cash, cash equivalents and investments totaling approximately $1.1 billion, as compared to $1.2 billion on December 31, 2019.
Commenting on first quarter 2020 results, Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, said, "With the arrival of COVID-19 to the many regions where we do business, BioMarin employees performed in unprecedented ways to ensure the continued supply of our critically-important medicines to the people we serve. I am proud of the commitment and dedication demonstrated by our colleagues in these challenging times. Our strong financial results in the first quarter underscore both the essential-nature of our products to patients and the extraordinary efforts made to maintain supply around the world. In the face of the many challenges of COVID-19, our regulatory team further progressed our next two potential commercial products. The Biologics License Application (BLA) for valoctocogene roxaparvovec for severe hemophilia A was accepted for Priority Review from the FDA with an action date of August 21, 2020. This milestone represents a tremendous achievement for BioMarin, but the potential approval of the first gene therapy in any type of hemophilia is an even greater triumph for the hemophilia community. They have been waiting decades for this groundbreaking advancement and we are honored to be on this journey together. With an approval decision for valoctocogene roxaparvovec expected later this year, our commercial team prepares eagerly to launch what we believe is the most innovative product yet for people with bleeding disorders."
Mr. Bienaimé continued, "Based on positive interactions with U.S. and European regulatory authorities in the quarter, we plan to submit marketing applications in both regions for vosoritide to treat children with achondroplasia in the third quarter of this year. Our multi-pronged dossier of data encompasses long-term clinical results in 5 to 18 year-olds, natural history data, the ongoing study of newborns through 5 years, and highly statistically significant placebo-controlled Phase 3 results. The positive and significant results from our vosoritide clinical programs have led us to believe that this potential drug could be the first pharmacological treatment for the underlying cause of achondroplasia. Interest in our clinical studies with vosoritide has been extremely robust, demonstrating that families are keen to seek early treatment for their children."
Mr. Bienaimé concluded, "2020 is expected to be a transformational year for BioMarin, despite impact from COVID-19 in the near-term. The agility demonstrated by BioMarin employees in the face of this global pandemic has enabled the continued supply of our essential medicines to the patients who need them. And while we expect minor financial impact in the near-term, our business is well-positioned to weather such challenges. Our first quarter revenue growth and improvement in profitability support our belief that 2020 continues to look poised to be one of our most significant value-creating years to date."
2020 Full-Year Financial Guidance
Due to the uncertainty surrounding the COVID-19 pandemic and the potential impact on its business, BioMarin is reducing its guidance for Total Revenues and Net Product Revenues for Vimizim, Naglazyme and Palynziq for 2020.
Item Provided February 26, 2020 Updated April 29, 2020
Total Revenues (1) $1,950 to $2,050 $1,850 to $1,950
Vimizim Net Product
Revenues $560 to $610 $530 to $570
Kuvan Net Product
Revenues $430 to $480
Unchanged
Naglazyme Net
Product Revenues $380 to $420 $360 to $400
Palynziq Net Product
Revenues $180 to $210 $160 to $190
Brineura Net Product
Revenues $85 to $115
Unchanged
Cost of Sales (% of 20 to 21
Total Revenues) % %
Unchanged
Research and
Development Expense $675 to $725
Unchanged
Selling, General and
Administrative
Expense $780 to $830
Unchanged
GAAP Net Income (2) $20 to $80
Unchanged
Non-GAAP Income (3) $260 to $310
Unchanged
(1) Updated Revenue guidance reflects
BioMarin's projected impact of the
COVID-19 pandemic on its global
revenue sources, mostly in the
form of demand interruptions such
as missed patient infusions and
delayed treatment starts for new
patients. The updated revenue
guidance assumes stabilization of
such interruptions in the second
half of 2020.
(2) 2020 GAAP Net Income guidance does
not reflect the potential impact
on non-cash GAAP income tax
associated with the tax effects of
potential intra-entity intangible
asset transfers between BioMarin
entities as a result of changing
international tax laws. Any such
changes, if implemented, are not
expected to have an impact on
operations or cash flows in 2020
but may have an impact on GAAP Net
Income in the form of an income
tax benefit of potentially greater
than $500 million.
(3) All Financial Guidance items are
calculated based on U.S. GAAP with
the exception of Non-GAAP Income/
Loss. Refer to Non-GAAP
Information beginning on page 10
of this press release for a
complete discussion of the
Company's Non-GAAP financial
information and reconciliations to
the corresponding GAAP reported
information.
Key Program Highlights
-- Valoctocogene roxaparvovec gene therapy for severe hemophilia A: The FDA
review of the BLA, under Priority Review, for valoctocogene roxaparvovec
is on-track with a PDUFA action date of August 21, 2020. On December 23,
2019, the Company announced that the European Medicines Agency (EMA)
validated the Company's Marketing Authorization Application (MAA) for
valoctocogene roxaparvovec which has been in review under accelerated
assessment since January. Although the MAA remains under accelerated
assessment at this time, the Company expects the review procedure to be
extended by at least 3 months due to COVID-19 delays. Further, the
Company believes there is a high possibility that the MAA will revert to
the standard review procedure, as is the case with most filings that
initially receive accelerated assessment. Because of the combination of
these events, the Company expects an opinion from the CHMP in late
2020/early 2021.The Company recently received EMA licensure of its gene
therapy manufacturing facility for the production of valoctocogene
roxaparvovec, an important step in obtaining regulatory approval of the
product in the EU. The Health Products Regulatory Authority (HPRA) of
Ireland conducted, on behalf of EMA, a pre-approval inspection in the
first quarter and issued a cGMP certification in the second quarter. The
inspection of the facility by FDA is expected to be complete during the
second quarter, which would allow for potential licensure of the
facility in the U.S. consistent with the August 21st PDUFA date.The
marketing applications are based on the Phase 3 interim analysis and the
updated three-year Phase 1/2 data from patients treated with
valoctocogene roxaparvovec. The Company believes that both submissions
represent the first time a gene therapy product for any type of
hemophilia indication is under review for marketing authorization by
health authorities. BioMarin has dosed 134 study participants in the
full GENEr8-1 Phase 3 study with 52-week results expected in the first
quarter of 2021. Although the trial is open label, BioMarin has
implemented a data access plan designed to substantially mirror a
blinded trial. This plan restricts the release of any ongoing data to a
small group of medical personnel monitoring and managing the trial, and
then, only to the extent necessary to perform their monitoring
responsibilities.BioMarin intends to provide a four-year update with the
6e13 vg/kg dose subjects and a three-year update with the 4e13 vg/kg
dose subjects from the ongoing Phase 2 study in mid-2020.
-- Vosoritide for children with achondroplasia: On April 6, 2020, the
Company announced that based on recent meetings with health authorities
in the U.S. and Europe, it plans to submit marketing applications to the
FDA and EMA in the third quarter of 2020. The marketing applications are
based on positive final results from its randomized, double-blind,
placebo-controlled Phase 3 study evaluating the efficacy and safety of
vosoritide. The placebo-adjusted increased change from baseline in
growth velocity after one year of treatment with vosoritide, the primary
endpoint, was 1.6 cm/yr (p<0.0001). Vosoritide is an investigational,
once daily injection analog of C-type Natriuretic Peptide (CNP). The
study enrolled 121 children aged 5 to 14 with achondroplasia, the most
common form of disproportionate short stature. The results were
consistent across the broad patient population studied. Vosoritide was
generally well tolerated with no clinically significant blood pressure
decreases. On November 14, 2019, the Company provided an update on the
ongoing Phase 2 study of vosoritide which demonstrated over 54 months
that children in cohort 3 (N=10) of the study, at a dose of 15
µg/kg/day, achieved a statistically significant (p< 0.005) cumulative
mean additional height gain of 9.0 cm compared to children, matched for
age and gender, in a new comprehensive natural history achondroplasia
dataset (N=619). 2.2 cm of this additional increase occurred in the last
12 months of treatment further informing our understanding of
vosoritide's ongoing treatment impact. These data are expected to
corroborate maintenance of effect at the time of anticipated marketing
application submissions later this year.The vosoritide development
program includes four distinct areas of focus to support global
approval. In addition to the completed Phase 3 study and ongoing Phase 2
study in children ages 5-14 years, the global program includes a large
contemporaneous natural history study which is underway.The fourth
component of the Company's global development program with vosoritide,
includes a large Phase 2 study in infants and young children (newborn to
60 months old) with achondroplasia, to determine the impact of treatment
in this age group. Cohorts 1 and 2 include children from ages 6 months
through 5 years of age, and has completed enrollment. Completion of
enrollment of cohort 3, which includes children ages 0 to 6 months old,
is expected to be somewhat delayed due to impact from COVID-19.
-- BMN 307 gene therapy product candidate for phenylketonuria (PKU): On
January 13, 2020 the Company announced that both the FDA and the
Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K.
have granted the Company Investigational New Drug (IND) status and
approved its Clinical Trial Application (CTA), respectively, for BMN
307.The impact of COVID-19 has created uncertainty about when it will be
safe for patients to be dosed in PHEARLESS, our Phase 1/2 study of BMN
307. The Company currently estimates that dosing will begin in the
second half of 2020. In the meantime, new sites are currently being
prepared to open and enroll patients. All subjects participating in the
PHEARLESS study will receive product made at commercial scale from
BioMarin's award-winning gene therapy manufacturing facility. Both the
FDA and EMA have granted BMN 307 Orphan Drug Status.Preclinical data
with BMN 307 demonstrated a lifetime Phe correction sustained at 80
weeks in mouse models. BMN 307 is an AAV vector containing the DNA
sequence that codes for the phenylalanine hydroxylase enzyme that is
deficient in people with PKU.
-- BMN 331 gene therapy product candidate for Hereditary Angioedema (HAE):
On November 14, 2019, the Company announced its third gene therapy
candidate, BMN 331, for the treatment of Hereditary Angioedema (HAE).
BioMarin plans to build on its ever wider and deeper expertise in
developing gene therapies for severe hemophilia A and PKU to improve
efficiencies in the development process, and to optimize capsid and
transgene design. The Company is monitoring developments surrounding
COVID-19 but expects to begin IND-enabling studies in mid-2020.
-- Vosoritide for the treatment of Dominantly Inherited Short Stature
(DISS): On November 14, 2019, the Company announced that vosoritide will
be studied in broader genetic statural abnormalities starting with
dominantly inherited short stature (DISS), as part of a research
collaboration with Children's National Hospital. The Company plans to
build on its learnings with vosoritide in achondroplasia and look for
efficiencies in the development process, particularly around
pre-clinical research and manufacturing. The Company is monitoring
developments surrounding COVID-19 but currently expects the trial with
vosoritide for DISS to begin in the second half of 2020.
-- Gene Therapy manufacturing productivity increases capacity: On January
13, 2020, the Company announced that significant improvements in
productivity in the gene therapy facility had increased capacity for up
to 10,000 patients per year, depending on dose and product mix.
BioMarin will host a conference call and webcast to discuss first quarter 2020 financial results today, Wednesday, April 29, 2020 at 4:15 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: Replay Dial-in Number:
833.360.0852 855.859.2056
International Dial-in Number: Replay International Dial-in
630.652.5841 Number: 404.537.3406
Conference ID: 6194595
Conference ID: 6194595
---
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for people with serious and life-threatening rare diseases and medical conditions. The Company selects product candidates for diseases and conditions that represent a significant unmet medical need, have well-understood biology and provide an opportunity to be first-to-market or offer a significant benefit over existing products. The Company's portfolio consists of several commercial therapies and multiple clinical and preclinical product candidates.
For additional information, please visit www.biomarin.com.
Forward-Looking Statements
This press release and the associated conference call and webcast contain forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc. (BioMarin), including, without limitation, statements about: the expectations of Total Revenues, Net Product Revenues, Research and Development Expense, Selling, General and Administrative Expense, Cost of Sales, GAAP Net Income, Non-GAAP Income, other specified income statement guidance for the full-year 2020, and 2020 being poised to be one of the Company's most significant value-creating years to date; the financial performance of BioMarin as a whole, including (i) BioMarin's expectation of a minor financial impact in the near term, (ii) BioMarin's business being well positioned to weather such challenges (iii) that BioMarin will become profitable on a GAAP basis for the first time in 2020 and (iv) that the COVID-19-related demand interruptions such as missed patient infusions and delayed treatment starts for new patients will stabilize in the second half of 2020; the timing of BioMarin's clinical development and commercial prospects, including (i) the Company's expectation that it will start dosing patients in the PHEARLESS study in the second half of 2020, the Company's expectation that it will begin IND-enabling studies for BMN 331 for HAE in mid-2020, and the Company's expectation that vosoritide will be studied in broader genetic statural deficiencies with DISS as part of a research collaboration with Children's National Hospital, with a clinical trial expected to begin the second half of 2020, (ii) BioMarin's clinical studies and trials, (iii) completion of enrollment of those studies and trials, and (iv) announcements of data from those studies and trials, including BioMarin's Phase 2 program with valoctocogene roxaparvovec; the clinical development and commercialization of BioMarin's product candidates and commercial products, including (i) BioMarin's plans to submit marketing applications for vosoritide for children with achondroplasia in the third quarter of 2020, (ii) the productivity, capacity and licensure of its gene therapy manufacturing facility, including the timing of such licensure, and (iii) the potential approval and commercialization of BioMarin's product candidates, including valoctocogene roxaparvovec for the treatment of severe hemophilia A, including timing of such approval decisions.
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; results and timing of current and planned preclinical studies and clinical trials, as well as the potential impact of the COVID-19 pandemic on (i) BioMarin's ability to continue such preclinical studies and clinical trials and (ii) the timing of such 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, including the potential impact of the COVID-19 pandemic on the regulatory authorities' abilities to issue such decisions and the timing of such decisions; the market for each of these products; actual sales of BioMarin's commercial products and the impact that the COVID-19 pandemic may have on such sales; the introduction of generic versions of BioMarin's commercial products, in particular generic versions of Kuvan; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission (SEC), including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's Annual Report on Form 10-K for the year ended December 31, 2019 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® and Vimizim® are registered trademarks of BioMarin Pharmaceutical Inc., or its affiliates. Aldurazyme® is a registered trademark of BioMarin/Genzyme LLC.
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2020 and December 31, 2019
(In thousands of U.S. dollars, except per share amounts)
March 31, 2020 December 31,
2019 (1)
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $
476,632 $
437,446
Short-term investments 381,764 316,361
Accounts receivable, net 396,384 377,404
Inventory 705,652 680,275
Other current assets 155,817 130,657
Total current assets 2,116,249 1,942,143
Noncurrent assets:
Long-term investments 290,796 411,978
Property, plant and equipment, net 1,009,972 1,010,868
Intangible assets, net 443,717 456,580
Goodwill 196,199 197,039
Deferred tax assets 539,990 549,422
Other assets 125,918 122,009
Total assets $
4,722,841 $
4,690,039
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued liabilities $
454,506 $
570,621
Short-term convertible debt, net 365,964 361,882
Total current liabilities 820,470 932,503
Noncurrent liabilities:
Long-term convertible debt, net 486,713 486,238
Long-term contingent consideration 50,524 50,793
Other long-term liabilities 125,172 98,124
Total liabilities $
1,482,879 $
1,567,658
Stockholders' equity:
Common stock, $0.001 par value: 500,000,000 shares authorized; 180,761,969
and 179,838,114 shares issued and outstanding, respectively. 181 180
Additional paid-in capital 4,854,814 4,832,707
Company common stock held by Nonqualified Deferred Compensation Plan (9,832) (9,961)
Accumulated other comprehensive income 34,127 20,164
Accumulated deficit (1,639,328) (1,720,709)
Total stockholders' equity 3,239,962 3,122,381
Total liabilities and stockholders' equity $
4,722,841 $
4,690,039
(1) December 31, 2019 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, 2019, filed with the U.S.
Securities and Exchange
Commission (SEC) on February 27,
2020.
BIOMARIN PHARMACEUTICAL INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended March 31, 2020 and 2019
(In thousands of U.S. dollars, except per share amounts)
Three Months Ended March 31,
2020 2019
(unaudited) (unaudited)
REVENUES:
Net product revenues $
489,043 $
394,483
Royalty and other revenues 13,026 6,262
Total net revenues 502,069 400,745
OPERATING EXPENSES:
Cost of sales 111,374 89,182
Research and development 142,257 183,591
Selling, general and administrative 187,295 162,158
Intangible asset amortization and
contingent consideration 15,677 19,765
Gain on sale of nonfinancial assets (59,495)
Total operating expenses 397,108 454,696
INCOME (LOSS) FROM OPERATIONS 104,961 (53,951)
Equity in the loss of BioMarin/
Genzyme LLC (77) (185)
Interest income 5,244 6,298
Interest expense (6,915) (6,727)
Other income, net (1,861) 1,608
INCOME (LOSS) BEFORE INCOME TAXES 101,352 (52,957)
Provision for income taxes 19,971 3,516
NET INCOME (LOSS) 81,381 (56,473)
NET INCOME (LOSS) PER SHARE, BASIC $
0.45 $
(0.32)
NET INCOME (LOSS) PER SHARE, DILUTED $
0.44 $
(0.32)
Weighted average common shares
outstanding, basic 179,898 178,271
Weighted average common shares
outstanding, diluted 187,163 178,271
The following table presents Net Product Revenues by Product:
Net Product Revenues by Product
(In millions of U.S. dollars)
Three Months Ended
March 31,
2020 2019 % Change
(unaudited) (unaudited)
Brineura $
24.0 $
12.2 97
%
Firdapse (1) 1.2 5.1 (76)
%
Naglazyme 114.3 86.9 32
%
PKU franchise 156.6 119.2 31
%
Vimizim 137.2 125.8 9
%
Net Product
Revenues
Marketed by
BioMarin 433.3 349.2
Aldurazyme Net
Product %
Revenues
Marketed by
Genzyme 55.7 45.3 23
Total Net
Product
Revenues $
489.0 $
394.5
(1) In January 2020, BioMarin
divested the Firdapse assets to
a third party in a sale
transaction. The sale is
reflected in the Company's
consolidated financial
statements for the three months
ending March 31, 2020; and as a
result of the transaction
BioMarin will not recognize Net
Product Revenues from Firdapse
in the future.
The following table presents Net Product Revenues for the PKU Franchise by Product:
Net Product Revenues by Product for the PKU Franchise
(In millions of U.S. dollars)
(unaudited)
Three Months Ended
March 31,
2020 2019 % Change
(unaudited) (unaudited)
Kuvan $
122.0 106.9 14
%
Palynziq 34.6 12.3 181
%
Total PKU $
156.6 $
119.2 31
franchise %
Non-GAAP Information
The results presented in this press release include both GAAP information and Non-GAAP information. As used in this release, Non-GAAP Income is defined by the Company as GAAP Net 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 when applicable. In addition, BioMarin includes in this press release the effects of these adjustments on certain components of GAAP Net Income/Loss for each of the periods presented. In this regard, Non-GAAP Income and its components, including Non-GAAP Cost of Sales, Non-GAAP Research and Development expenses, Non-GAAP Selling, General and Administrative expense, Non-GAAP Intangible Asset Amortization and Contingent Consideration, Non-GAAP Gain on the Sale of Intangible Asset and Non-GAAP Benefit From Income Taxes are statement of operations line items prepared on the same basis as, and therefore components of, the overall Non-GAAP measures.
BioMarin regularly uses both GAAP and Non-GAAP results and expectations internally to assess its financial operating performance and evaluate key business decisions related to its principal business activities: the discovery, development, manufacture, marketing and sale of innovative biologic therapies. Because Non-GAAP Income and its components are important internal measurements for BioMarin, the Company believes that providing this information in conjunction with BioMarin's GAAP information enhances investors' and analysts' ability to meaningfully compare the Company's results from period to period and to its forward-looking guidance, and to identify operating trends in the Company's principal business. BioMarin also uses Non-GAAP Income internally to understand, manage and evaluate its business and to make operating decisions, and compensation of executives is based in part on this measure.
Non-GAAP Income and its components are not meant to be considered in isolation, as a substitute for, or superior to comparable GAAP measures and should be read in conjunction with the consolidated financial information prepared in accordance with GAAP. Investors should note that the Non-GAAP information is not prepared under any comprehensive set of accounting rules or principles and does not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these Non-GAAP measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its Non-GAAP measures; likewise, the Company may in the future cease to exclude items that it has historically excluded for purposes of its Non-GAAP measures. Because of the non-standardized definitions, the Non-GAAP measure as used by BioMarin in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
The following table presents the reconciliation of GAAP Net Income (Loss) to Non-GAAP Income:
Reconciliation of GAAP Net Income (Loss) to Non-GAAP Income
(In millions of U.S. dollars)
(unaudited)
Three Months Ended
Guidance
March 31,
Year Ending
2020 2019
December 31, 2020
GAAP Net Income
(Loss) $
81.4 $
(56.5) $
20.0 $
80.0
Interest expense,
net 1.7 0.4 3.0 2.0
Provision for income
taxes 20.0 3.5 4.5 10.5
Depreciation expense 10.3 14.9 50.0 47.0
Amortization expense 15.7 7.5 63.0 61.0
Stock-based
compensation
expense 46.9 42.7 177.0 167.0
Contingent
consideration
expense - 12.3 2.0 2.0
Gain on sale of
nonfinancial assets (59.5) (59.5) (59.5)
Non-GAAP Income $
116.5 $
24.8 $
260.0 $
310.0
The following reconciliation of the GAAP reported to the Non-GAAP information provides the details of the effects of the Non-GAAP adjustments on certain components of the Company's operating results for each of the periods presented.
Reconciliation of Certain GAAP Reported Information to Non-GAAP Information
(In millions of U.S. dollars)
(unaudited)
Three months ended March 31,
2020 2019
Adjustments Adjustments
GAAP Interest, Stock-Based Non-GAAP GAAP Interest, Stock-Based Non-GAAP
Compensation,
Reported Taxes, Compensation, Reported Taxes, Contingent
Consideration
Depreciation Contingent Depreciation and Other
Adjustments
and Consideration and
Amortization and Other Amortization
Adjustments
Cost of sales $
111.4
$ $
(5.1) $
106.3 $
89.2
$ $
(4.8) $
84.4
Research and
development 142.3 (4.8) (13.7) 123.8 183.6 (9.3) (13.8) 160.5
Selling, general
and administrative 187.3 (5.5) (28.1) 153.7 162.2 (5.6) (24.1) 132.5
Intangible asset
amortization and
contingent
consideration 15.7 (15.7) 19.8 (7.5) (12.3)
Gain on sale of
nonfinancial
assets (59.5) 59.5
Interest expense,
net (1.7) 1.7 (0.4) 0.4
Provision for
income taxes 20.0 (20.0) 3.5 (3.5)
GAAP Net Income
(Loss)/Non-GAAP
Income $
81.4 $
47.7 $
(12.6) $
116.5 $
(56.5) $
26.3 $
55.0 $
24.8
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.
