- 1Q20 total revenues of $1,444.8 million, a 27 percent increase
over 1Q19
- 1Q20 GAAP diluted EPS of $2.50; non-GAAP diluted EPS of
$3.22
- Received positive CHMP opinion for ULTOMIRIS® (ravulizumab) in
atypical hemolytic uremic syndrome (aHUS) in the EU
- Advanced ULTOMIRIS as standard of care in PNH with more than
67% patient conversion from SOLIRIS® (eculizumab) in U.S., Germany
and Japan
- Further diversified development-stage and commercial-stage
portfolios with close of Achillion acquisition and announced
agreement to acquire Portola
- Provided update on COVID-19 related activities and impact
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced
financial results for the first quarter of 2020. Total revenues in
the first quarter were $1,444.8 million, a 27 percent increase
compared to the same period in 2019. The negative impact of foreign
currency on total revenues year-over-year was 1 percent, or $15.7
million, inclusive of hedging activities. On a GAAP basis, diluted
EPS in the quarter was $2.50, a 4 percent decrease versus the prior
year. Non-GAAP diluted EPS for the first quarter of 2020 was $3.22,
a 35 percent increase versus the first quarter of 2019.
"We had a strong first quarter across our global commercial
business, driven by substantial growth in the number of patients
we're treating with our medicines. We also made significant
progress diversifying our portfolio through business development,
with the close of the Achillion acquisition and the announcement
that we have entered into an agreement to acquire Portola," said
Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "As
COVID-19 continues to reach across the globe, we are adapting our
ways of working to ensure we maintain our ability to continue
serving patients. This pandemic has had, and will undoubtedly
continue to have near-term and lasting impacts on our business and
ways of operating, but I am proud of the way our teams have
responded during this challenging time. Thanks to their dedication,
I am confident we will be able to continue executing on our
strategy and delivering long-term shareholder value by advancing
our mission of developing and delivering transformative
medicines."
First Quarter 2020 Financial
Highlights
- Net product sales were $1,444.6 million in the first quarter of
2020, compared to $1,140.2 million in the first quarter of
2019.
- SOLIRIS net product sales were $1,022.9 million, compared to
$962.0 million in the first quarter of 2019, representing a 6
percent increase.
- ULTOMIRIS net product sales were $222.8 million, compared to
$24.6 million in the first quarter of 2019.
- STRENSIQ net product sales were $172.2 million, compared to
$130.1 million in the first quarter of 2019, representing a 32
percent increase.
- KANUMA net product sales were $26.7 million, compared to $23.5
million in the first quarter of 2019, representing a 14 percent
increase.
- GAAP cost of sales was $111.7 million, compared to $85.8
million in the first quarter of 2019. Non-GAAP cost of sales was
$108.6 million, compared to $82.1 million in the first quarter of
2019.
- GAAP R&D expense was $200.9 million, compared to $195.9
million in the first quarter of 2019. Non-GAAP R&D expense was
$185.7 million, compared to $159.4 million in the first quarter of
2019.
- GAAP SG&A expense was $319.9 million, compared to $281.5
million in the first quarter of 2019. Non-GAAP SG&A expense was
$259.1 million, compared to $243.7 million in the first quarter of
2019.
- GAAP income tax expense was $106.0 million, compared to income
tax benefit of $46.1 million in the first quarter of 2019. GAAP
income tax benefit in the first quarter of 2019 includes deferred
tax benefits of $95.7 million and $30.3 million associated with a
tax election related to intellectual property and release of an
existing valuation allowance, respectively. Non-GAAP income tax
expense was $141.2 million, compared to $100.9 million in the first
quarter of 2019.
- GAAP diluted EPS was $2.50, compared to $2.61 in the first
quarter of 2019. GAAP diluted EPS for the first quarter of 2019
includes deferred tax benefits of $95.7 million and $30.3 million
associated with a tax election related to intellectual property and
release of an existing valuation allowance, respectively. Non-GAAP
diluted EPS was $3.22, compared to $2.39 in the first quarter of
2019.
COVID-19
The COVID-19 pandemic continues to significantly impact the
global communities in which we live and work, and healthcare
systems in particular. Alexion is continually monitoring the
evolving situation and adjusting our operations as needed to
support the safety and well-being of our employees and the patients
and communities we serve. We are also focused on minimizing
potential interactions that could contribute to the spread of the
virus and put additional strain on healthcare systems through the
use of innovative virtual means wherever possible.
- Clinical Trials: We are committed to continuing our
clinical trials with as little interruption as possible, while also
being sensitive to the local dynamics and pressures in many
countries and locations where these trials are being conducted.
While the COVID-19 impact varies by study and program, generally,
we expect there will be little timing impact on fully-enrolled
trials and a timing shift of at least three months on trials that
are enrolling patients and activating sites, or have not yet
started to do so. In addition, all healthy volunteer studies have
been temporarily paused.
- Business Impact: We have taken proactive measures
designed to mitigate the risk of potential interruptions in supply
and/or access to patients' customary site-of-care locations. There
has been emerging evidence of accelerated conversion from SOLIRIS
to ULTOMIRIS, potentially driven by its decreased burden on the
healthcare system. We have also seen initial signs of slowing new
patient initiations and delays in treatment starts and will
continue to monitor this environment as the pandemic
continues.
- COVID-19 Development Program: We are exploring the
potential role of ULTOMIRIS and SOLIRIS for the treatment of severe
COVID-19 and have recently initiated a Phase 3 randomized
controlled trial of ULTOMIRIS in a subset of adults with COVID-19.
We have also donated supply of SOLIRIS for compassionate use and
expanded access programs.
- Financial Guidance: We have updated our financial
guidance to reflect these dynamics and assume a gradual re-opening
of healthcare system access starting in July.
Research and Development
PHASE 3
- SOLIRIS - Neuromyelitis Optica Spectrum Disorder
(NMOSD): Alexion plans to initiate a Phase 2/3 study in
children and adolescents with NMOSD in mid-2020.
- SOLIRIS - Generalized Myasthenia Gravis (gMG): A Phase 3
study of SOLIRIS in children and adolescents with gMG is
underway.
- ULTOMIRIS - Severe COVID-19: In April 2020, Alexion
announced U.S. Food and Drug Administration (FDA) acceptance of an
investigational new drug application for ULTOMIRIS in severe
COVID-19 and initiated a Phase 3 randomized controlled trial in
adults with COVID-19 who are hospitalized with severe pneumonia or
acute respiratory distress syndrome.
- ULTOMIRIS - Paroxysmal Nocturnal Hemoglobinuria (PNH): A
Phase 3 study of ULTOMIRIS in children and adolescents with PNH is
underway.
- ULTOMIRIS - Atypical Hemolytic Uremic Syndrome (aHUS):
In April 2020, Alexion announced a positive opinion for ULTOMIRIS
in aHUS from the European Medicines Agency Committee for Medicinal
Products for Human Use. An application for approval of ULTOMIRIS
for aHUS is also under review in Japan. A Phase 3 study of
ULTOMIRIS in children and adolescents with aHUS is underway.
- ULTOMIRIS - 100mg/mL: Applications for approval of
ULTOMIRIS 100mg/mL formulation are under review in the EU and U.S.
The FDA has set a Prescription Drug User Fee Act target action date
of October 11, 2020. This higher concentration formulation is
designed to reduce infusion time by more than 50 percent to
approximately 45 minutes. Alexion plans to file for regulatory
approval of this formulation in Japan in mid-2020.
- ULTOMIRIS - Subcutaneous: Enrollment is complete in a
single, PK-based Phase 3 study of ULTOMIRIS delivered
subcutaneously once per week to support registration in PNH and
aHUS. Data are expected in the first half of 2020.
- ULTOMIRIS - gMG: A Phase 3 study of ULTOMIRIS in adults
with gMG is underway.
- ULTOMIRIS - NMOSD: A Phase 3 study of ULTOMIRIS in NMOSD
is underway.
- ULTOMIRIS - Amyotrophic Lateral Sclerosis (ALS):
In March 2020, Alexion began dosing patients in a Phase 3 study of
ULTOMIRIS in ALS.
- ULTOMIRIS - Hematopoietic Stem Cell Transplant-Associated
Thrombotic Microangiopathy (HSCT-TMA): Alexion plans to
initiate limited dose-ranging studies in the second half of 2020,
followed by Phase 3 trials in 2021, pending regulatory
feedback.
- ULTOMIRIS - Complement Mediated Thrombotic Microangiopathy
(CM-TMA): Alexion plans to initiate a Phase 3 study of
ULTOMIRIS in CM-TMA in the second half of 2020, pending regulatory
feedback.
- ULTOMIRIS - Renal Diseases: Alexion plans to initiate a
proof-of-concept trial of ULTOMIRIS in patients with various renal
diseases in 2020.
- ALXN1840 (WTX101) - Wilson Disease: Enrollment is
complete in a Phase 3 study of ALXN1840 in Wilson disease. Study
results are expected in the first half of 2021.
- CAEL-101 - Caelum Biosciences: Alexion is collaborating
with Caelum Biosciences to develop CAEL-101 for light chain (AL)
amyloidosis. A pivotal Phase 2/3 program will investigate CAEL-101
as an add-on to current standard-of-care therapy. In March 2020,
the companies began dosing patients in the Phase 2 dose selection
portion of the program; the Phase 3 portion of the program is
planned to begin later in 2020, pending dose selection.
- AG10 - Eidos: Alexion holds an exclusive license to
develop and commercialize AG10 in Japan. Eidos is currently
evaluating AG10 in a Phase 3 study in the U.S. and Europe for ATTR
cardiomyopathy (ATTR-CM) and plans to begin a Phase 3 study in ATTR
polyneuropathy (ATTR-PN) in 2020. Alexion plans to expand the AG10
program into Japan in 2020, pending regulatory feedback.
PHASE 1/2
- ALXN1830 (SYNT001): Due to COVID-19, Alexion has
temporarily paused the Phase 2 study of ALXN1830, administered
intravenously, in warm autoimmune hemolytic anemia (WAIHA), as well
as the Phase 1 study of a subcutaneous formulation of ALXN1830 in
healthy volunteers. These trials and the planned Phase 2 study of
subcutaneous ALXN1830 in gMG are anticipated to begin in 2021.
- ALXN2040 (Danicopan/ACH-4471) - PNH with Extravascular
Hemolysis (EVH): Alexion plans to initiate a Phase 3 study of
ALXN2040 as an add-on therapy for PNH patients with EVH by the end
of 2020.
- ALXN2040 - C3 Glomerulopathy (C3G): Phase 2 studies of
ALXN2040 in C3G is underway. Interim data are expected in the
second quarter of 2020.
- ALXN2050 (ACH-5228) - PNH: A Phase 2 to study of
ALXN2050 in PNH is underway.
- ABY-039 - Affibody AB: In February 2020, Alexion
terminated its agreement to co-develop ABY-039 with Affibody based
on data from a Phase I study.
- ALXN1720: Seven of nine cohorts are complete in a Phase
1 healthy volunteer study of ALXN1720, a novel anti-C5
albumin-binding bi-specific mini-body that binds and prevents
activation of human C5. Due to COVID-19, the study is temporarily
paused.
2020 Financial Guidance
Alexion is decreasing total revenues and EPS guidance and
increasing non-GAAP operating margin guidance. Full guidance
updates are outlined below.
Previous
Updated
Total revenues
$5,500 to $5,560 million
$5,230 to $5,330 million
SOLIRIS/ULTOMIRIS revenues
$4,755 to $4,800 million
$4,495 to $4,570 million
Metabolic revenues
$745 to $760 million
$735 to $760 million
R&D (% total revenues)
GAAP
19.0% to 22.5%
17.5% to 18.6%
Non-GAAP
17.5% to 18.5%
16.0% to 17.0%
SG&A (% total revenues)
GAAP
22.7% to 24.0%
22.2% to 23.5%
Non-GAAP
19.5% to 20.5%
18.5% to 19.5%
Operating margin
GAAP
39.3% to 43.5%
42.4% to 43.8%
Non-GAAP
53.5% to 54.5%
55.0% to 56.0%
Earnings per share
GAAP
$7.91 to $8.71
$8.14 to $8.47
Non-GAAP
$10.65 to $10.85
$10.45 to $10.75
Updated 2020 financial guidance assumes a GAAP effective tax
rate of 15.0 to 16.0 percent and a non-GAAP effective tax rate of
15.5 to 16.5 percent. The 2020 GAAP and non-GAAP tax rates do not
benefit from one-time events that benefited the tax rates in
2019.
Updated 2020 financial guidance excludes the impact of the
recently announced agreement to acquire Portola.
Alexion’s financial guidance is based on current foreign
exchange rates net of hedging activities and does not include the
effect of acquisitions, license and other strategic agreements,
intangible asset impairments, litigation charges, changes in fair
value of contingent consideration, gains or losses related to
strategic equity investments or restructuring and related activity
outside of the previously announced activities that may occur after
the issuance of this press release.
Conference Call/Webcast Information:
Alexion will host a conference call/audio webcast to discuss the
first quarter 2020 results today at 8:00 a.m. Eastern Time. To
participate in the call, dial 866-762-3111 (USA) or 210-874-7712
(International), conference ID 1645087 shortly before 8:00 a.m.
Eastern Time. A replay of the call will be available for a limited
period following the call. The audio webcast can be accessed on the
Investor page of Alexion’s website at: http://ir.alexion.com.
About Alexion
Alexion is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases through the
discovery, development and commercialization of life-changing
medicines. As the global leader in complement biology and
inhibition for more than 20 years, Alexion has developed and
commercializes two approved complement inhibitors to treat patients
with paroxysmal nocturnal hemoglobinuria (PNH) and atypical
hemolytic uremic syndrome (aHUS), as well as the first and only
approved complement inhibitor to treat anti-acetylcholine receptor
(AchR) antibody-positive generalized myasthenia gravis (gMG) and
neuromyelitis optica spectrum disorder (NMOSD). Alexion also has
two highly innovative enzyme replacement therapies for patients
with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency
(LAL-D). In addition, the company is developing several
mid-to-late-stage therapies, including a copper-binding agent for
Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for
rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D
inhibitor as well as several early-stage therapies, including one
for light chain (AL) amyloidosis, a second oral Factor D inhibitor
and a third complement inhibitor. Alexion focuses its research
efforts on novel molecules and targets in the complement cascade
and its development efforts on the core therapeutic areas of
hematology, nephrology, neurology, metabolic disorders and
cardiology. Headquartered in Boston, Massachusetts, Alexion has
offices around the globe and serves patients in more than 50
countries. This press release and further information about Alexion
can be found at: www.alexion.com.
[ALXN-E]
Forward-Looking Statement
This press release contains forward-looking statements,
including statements related to: guidance regarding anticipated
financial results for 2020 (and the assumptions related to such
guidance); our expectations regarding the affects COVID-19 will
have on our business and operations, including clinical trials and
product supply; the strength of our business and continued growth;
plans to expand the Company's pipeline; future plans for, and the
timing for, the commencement of future clinical trials and the
expected timing of the receipt of results of certain clinical
trials and studies, including clinical programs for ULTOMIRIS, a
higher concentration formulation of ULTOMIRIS, SOLIRIS, ALXN1840,
CAEL-101, AG10, ALXN2040 and ALXN1830; potential benefits of
current products and products under development and in clinical
trials; plans for development programs with third parties; and
Alexion's future clinical, regulatory, and commercial plans for
ULTOMIRIS and other products and product candidates.
Forward-looking statements are subject to factors that may cause
Alexion's results and plans to differ materially from those
forward-looking statements, including for example: our dependence
on sales from our principal product (SOLIRIS); our ability to
facilitate the timely conversion of from SOLIRIS to ULTOMIRIS;
payer, physician and patient acceptance of ULTOMIRIS as an
alternative to SOLIRIS; the impact of the COVID-19 pandemic on
Alexion’s business, including its sales, clinical trials,
operations and supply chain; the proposed acquisition of Portola by
Alexion may not be completed; appropriate pricing for ULTOMIRIS;
future competition from biosimilars and novel products; decisions
of regulatory authorities regarding the adequacy of our research,
marketing approval or material limitations on the marketing of our
products; delays or failure of product candidates to obtain
regulatory approval; delays or the inability to launch product
candidates due to regulatory restrictions, anticipated expense or
other matters; interruptions or failures in the manufacture and
supply of our products and our product candidates; failure to
satisfactorily address matters raised by the FDA and other
regulatory agencies; results in early stage clinical trials may not
be indicative of full results or results from later stage or larger
clinical trials (or broader patient populations) and do not ensure
regulatory approval; the possibility that results of clinical
trials are not predictive of safety and efficacy and potency of our
products (or we fail to adequately operate or manage our clinical
trials) which could cause us to halt trials, delay or prevent us
from making regulatory approval filings or result in denial of
approval of our product candidates; unexpected delays in clinical
trials; unexpected concerns that may arise from additional data or
analysis obtained during clinical trials; future product
improvements may not be realized due to expense or feasibility or
other factors; uncertainty of long-term success in developing,
licensing or acquiring other product candidates or additional
indications for existing products; inability to complete planned
acquisitions due to failure of regulatory approval or material
changes in target or otherwise; inability to complete acquisitions
and investments due to increased competition for technology; the
possibility that current rates of adoption of our products are not
sustained; the adequacy of our pharmacovigilance and drug safety
reporting processes; failure to protect and enforce our data,
intellectual property and proprietary rights and the risks and
uncertainties relating to intellectual property claims, lawsuits
and challenges against us (including intellectual property lawsuits
relating to ULTOMIRIS brought by third parties against Alexion and
inter partes review petitions submitted by third parties); the risk
that third party payors (including governmental agencies) will not
reimburse or continue to reimburse for the use of our products at
acceptable rates or at all; failure to realize the benefits and
potential of investments, collaborations, licenses and
acquisitions; the possibility that expected tax benefits will not
be realized; assessment of impact of recent accounting
pronouncements; potential declines in sovereign credit ratings or
sovereign defaults in countries where we sell our products; delay
of collection or reduction in reimbursement due to adverse economic
conditions or changes in government and private insurer regulations
and approaches to reimbursement; uncertainties surrounding legal
proceedings, company investigations and government investigations,
including investigations of Alexion by the U.S. Securities and
Exchange Commission (SEC) and U.S. Department of Justice; the risk
that estimates regarding the number of patients with PNH, aHUS,
gMG, NMOSD, HPP and LAL-D and other indications we are pursuing are
inaccurate; the risks of changing foreign exchange rates; risks
relating to the potential effects of the Company's restructuring;
risks related to the acquisition of companies and co-development
and collaboration efforts; and a variety of other risks set forth
from time to time in Alexion's filings with the SEC, including but
not limited to the risks discussed in Alexion's Annual Report on
Form 10-K for the period ended December 31, 2019 and in our other
filings with the SEC. Alexion disclaims any obligation to update
any of these forward-looking statements to reflect events or
circumstances after the date hereof, except when a duty arises
under law.
In addition to financial information prepared in accordance with
GAAP, this press release also contains non-GAAP financial measures
that Alexion believes, when considered together with the GAAP
information, provide investors and management with supplemental
information relating to performance, trends and prospects that
promote a more complete understanding of our operating results and
financial position during different periods. Alexion also uses
these non-GAAP financial measures to establish budgets, set
operational goals and to evaluate the performance of the business.
The non-GAAP results, determined in accordance with our internal
policies, exclude the impact of the following GAAP items (see
reconciliation tables below for additional information):
share-based compensation expense, fair value adjustment of
inventory acquired, amortization of purchased intangible assets,
changes in fair value of contingent consideration, restructuring
and related expenses, upfront payments related to licenses and
other strategic agreements, acquired in-process research and
development, impairment of purchased intangible assets, gains and
losses related to strategic equity investments, litigation charges,
gain or loss on sale of a business or asset, gain or loss related
to purchase options, contingent milestone payments associated with
acquisitions of legal entities accounted for as asset acquisitions,
acquisition-related costs and certain adjustments to income tax
expense. These non-GAAP financial measures are not intended to be
considered in isolation or as a substitute for, or superior to, the
financial measures prepared and presented in accordance with GAAP,
and should be reviewed in conjunction with the relevant GAAP
financial measures. Please refer to the attached Reconciliations of
GAAP to non-GAAP Financial Results and GAAP to non-GAAP 2020
Financial Guidance for explanations of the amounts adjusted to
arrive at non-GAAP net income and non-GAAP earnings per share
amounts for the three month periods ended March 31, 2020 and 2019
and projected twelve months ending December 31, 2020.
(Tables Follow)
ALEXION PHARMACEUTICALS,
INC.
TABLE 1: CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in millions, except per share
amounts)
(unaudited)
Three months ended
March 31,
2020
2019
Net product sales
$
1,444.6
$
1,140.2
Other revenue
0.2
0.2
Total revenues
1,444.8
1,140.4
Costs and expenses:
Cost of sales (exclusive of amortization
of purchased intangible assets)
111.7
85.8
Research and development
200.9
195.9
Selling, general and administrative
319.9
281.5
Amortization of purchased intangible
assets
73.7
80.0
Change in fair value of contingent
consideration
5.8
(28.7
)
Acquisition-related costs
38.1
—
Restructuring expenses
(0.8
)
9.1
Total costs and expenses
749.3
623.6
Operating income
695.5
516.8
Other income and expense:
Investment (expense) income
(5.2
)
42.5
Interest expense
(25.8
)
(19.9
)
Other income and (expense)
(0.9
)
2.4
Income before income taxes
663.6
541.8
Income tax expense (benefit)
106.0
(46.1
)
Net income
$
557.6
$
587.9
Earnings per common share
Basic
$
2.52
$
2.63
Diluted
$
2.50
$
2.61
Shares used in computing earnings per
common share
Basic
221.6
223.8
Diluted
222.6
225.5
ALEXION PHARMACEUTICALS,
INC.
TABLE 2: RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL RESULTS
(in millions, except per share
amounts)
(unaudited)
Three months ended
March 31,
2020
2019
GAAP net income
$
557.6
$
587.9
Before tax adjustments:
Cost of sales:
Share-based compensation
3.1
3.7
Research and development expense:
Share-based compensation
15.2
15.3
Upfront payments related to licenses and
other strategic agreements (1)
—
21.2
Selling, general and administrative
expense:
Share-based compensation
39.3
37.7
Litigation charges (2)
21.5
0.1
Amortization of purchased intangible
assets
73.7
80.0
Change in fair value of contingent
consideration (3)
5.8
(28.7
)
Acquisition-related costs (4)
38.1
—
Restructuring expenses
(0.8
)
9.1
Investment income (expense):
(Gains) and losses related to strategic
equity investments (5)
9.2
(33.8
)
Adjustments to income tax expense (6)
(35.2
)
(147.0
)
Non-GAAP net income
$
727.5
$
545.5
GAAP earnings per common share -
diluted
$
2.50
$
2.61
Non-GAAP earnings per common share -
diluted
$
3.22
$
2.39
Shares used in computing diluted earnings
per common share (GAAP)
222.6
225.5
Shares used in computing diluted earnings
per common share (non-GAAP)
226.0
228.1
(1)
During the three months ended March 31,
2019, we recorded expense of $21.2 million in connection with an
upfront payment on a strategic agreement that we entered into with
Zealand Pharma A/S.
(2)
During the three months ended March 31,
2020, we recorded $21.5 million in litigation charges in connection
with ongoing investigations.
(3)
Changes in the fair value of contingent
consideration expense for the three months ended March 31, 2020 and
2019 include the impact of the interest component of contingent
consideration related to the passage of time. Changes in fair value
of contingent consideration expense for the three months ended
March 31, 2019 also include the impact of changes in the expected
timing of payments of contingent consideration.
(4)
For the three months ended March 31, 2020,
we recorded $38.1 million of acquisition-related costs in
connection with the Achillion acquisition. Acquisition-related
costs primarily consist of transaction costs, costs associated with
the accelerated vesting of stock options previously granted to
Achillion employees and restructuring-related costs.
(5)
During the three months ended March 31,
2020 and March 31, 2019, we recognized unrealized losses (gains) of
9.2 million and $(33.8) million, respectively, in investment income
to adjust our strategic equity investments to fair value.
(6)
Alexion's non-GAAP income tax expense for
the three months ended March 31, 2020 and 2019 excludes the tax
effect of pre-tax adjustments to GAAP profit. Non-GAAP income tax
expense for the three months ended March 31, 2019 also excludes
certain one-time tax benefits of $95.7 million and $30.3 million
associated with a tax election made with respect to intellectual
property of Wilson and a release of an existing valuation
allowance, respectively.
ALEXION PHARMACEUTICALS,
INC.
TABLE 3: RECONCILIATION OF
GAAP TO NON-GAAP FINANCIAL GUIDANCE
(in millions, except per share
amounts and percentages)
(unaudited)
Twelve months ending
December 31, 2020
Low
High
GAAP net income
$
1,803
$
1,875
Before tax adjustments:
Share-based compensation
285
272
Amortization of purchased intangible
assets
295
295
Acquisition-related costs
39
39
Change in fair value of contingent
consideration
21
21
Restructuring expenses
(1
)
(1
)
Gains and losses related to strategic
equity investments
9
9
Litigation charges
22
22
Adjustments to income tax expense
(122
)
(113
)
Non-GAAP net income
$
2,351
$
2,419
Diluted GAAP earnings per common share
$
8.14
$
8.47
Diluted non-GAAP earnings per common
share
$
10.45
$
10.75
Costs and expenses and margin (% total
revenues)
GAAP research and development expense
18.6
%
17.5
%
Share-based compensation
1.6
%
1.5
%
Non-GAAP research and development
expense
17.0
%
16.0
%
GAAP selling, general and administrative
expense
23.5
%
22.2
%
Share-based compensation
3.5
%
3.3
%
Litigation charges
0.4
%
0.4
%
Non-GAAP selling, general and
administrative expense
19.5
%
18.5
%
GAAP operating margin
42.4
%
43.8
%
Share-based compensation
5.4
%
5.1
%
Litigation charges
0.4
%
0.4
%
Amortization of purchased intangible
assets
5.6
%
5.5
%
Acquisition-related costs
0.7
%
0.7
%
Change in fair value of contingent
consideration
0.4
%
0.4
%
Restructuring expenses
0.0
%
0.0
%
Non-GAAP operating margin
55.0
%
56.0
%
Income tax expense (% of income before
income taxes)
GAAP income tax expense
16.0
%
15.0
%
Tax effect of pre-tax adjustments to GAAP
net income
0.5
%
0.5
%
Non-GAAP income tax expense
16.5
%
15.5
%
Amounts may not foot due to rounding.
ALEXION PHARMACEUTICALS,
INC.
TABLE 4: NET PRODUCT SALES BY
GEOGRAPHY
(in millions)
(unaudited)
Three months ended
March 31,
2020
2019
SOLIRIS
United States
$
556.2
$
463.7
Europe
263.5
264.5
Asia Pacific
87.1
100.9
Rest of World
116.1
132.9
Total SOLIRIS
$
1,022.9
$
962.0
ULTOMIRIS
United States
$
131.5
$
24.6
Europe
33.8
—
Asia Pacific
57.1
—
Rest of World
0.4
—
Total ULTOMIRIS
$
222.8
$
24.6
STRENSIQ
United States
$
128.1
$
99.5
Europe
24.0
17.5
Asia Pacific
13.6
9.9
Rest of World
6.5
3.2
Total STRENSIQ
$
172.2
$
130.1
KANUMA
United States
$
16.4
$
13.8
Europe
7.5
6.3
Asia Pacific
0.9
0.8
Rest of World
1.9
2.6
Total KANUMA
$
26.7
$
23.5
Net Product Sales
United States
$
832.2
$
601.6
Europe
328.8
288.3
Asia Pacific
158.7
111.6
Rest of World
124.9
138.7
Total Net Product Sales
$
1,444.6
$
1,140.2
ALEXION PHARMACEUTICALS,
INC.
TABLE 5: CONDENSED
CONSOLIDATED BALANCE SHEETS
(in millions)
(unaudited)
March 31,
December 31,
2020
2019
Cash and cash equivalents
$
2,315.0
$
2,685.5
Marketable securities
47.8
64.0
Trade accounts receivable, net
1,345.2
1,243.2
Inventories
586.8
627.6
Prepaid expenses and other current
assets
575.4
456.1
Property, plant and equipment, net
1,159.9
1,163.3
Intangible assets, net
4,187.6
3,344.3
Goodwill
5,072.1
5,037.4
Right of use operating assets
203.2
204.0
Deferred tax assets
2,223.5
2,290.2
Other assets
432.0
429.0
Total assets
$
18,148.5
$
17,544.6
Accounts payable and accrued expenses
$
862.8
$
966.7
Current portion of long-term debt
126.7
126.7
Other current liabilities
130.4
100.9
Long-term debt, less current portion
2,343.3
2,375.0
Contingent consideration
358.9
192.4
Deferred tax liabilities
2,113.3
2,081.4
Noncurrent operating lease liabilities
162.8
164.1
Other liabilities
302.5
265.6
Total liabilities
6,400.7
6,272.8
Total stockholders' equity
11,747.8
11,271.8
Total liabilities and stockholders'
equity
$
18,148.5
$
17,544.6
ALEXION PHARMACEUTICALS,
INC.
TABLE 6: CONDENSED
CONSOLIDATED STATEMENT OF CASH FLOWS
(in millions)
(unaudited)
Three months ended March
31,
2020
2019
Cash flows from operating
activities:
Net income
$
557.6
$
587.9
Adjustments to reconcile net income to net
cash flows from operating activities:
Depreciation and amortization
89.3
97.2
Change in fair value of contingent
consideration
5.8
(28.7
)
Share-based compensation expense
57.6
56.7
Deferred taxes (benefit)
49.0
(81.1
)
Unrealized foreign currency loss
7.1
1.9
Unrealized (gain) loss on forward
contracts
(15.0
)
5.5
Unrealized loss (gain) on strategic equity
investments
9.2
(33.8
)
Other
13.7
(2.4
)
Changes in operating assets and
liabilities, excluding the effect of acquisitions:
Accounts receivable
(120.9
)
(95.3
)
Inventories
37.3
(11.2
)
Prepaid expenses, right of use operating
assets and other assets
(72.9
)
(58.6
)
Accounts payable, accrued expenses, lease
liabilities and other liabilities
(68.2
)
(8.2
)
Net cash provided by operating
activities
549.6
429.9
Cash flows from investing
activities:
Purchases of available-for-sale debt
securities
(19.4
)
—
Proceeds from maturity or sale of
available-for-sale debt securities
141.4
92.6
Purchases of mutual funds related to
nonqualified deferred compensation plan
(6.9
)
(5.8
)
Proceeds from sale of mutual funds related
to nonqualified deferred compensation plan
3.3
3.7
Purchases of property, plant and
equipment
(12.2
)
(36.0
)
Payment for acquisition of business, net
of cash acquired
(837.7
)
—
Purchases of strategic equity investments
and options
(34.5
)
(43.8
)
Purchase of intangible assets
—
(8.0
)
Other
—
0.2
Net cash (used in) provided by investing
activities
(766.0
)
2.9
Cash flows from financing
activities:
Payments on term loan
(32.6
)
—
Payments on revolving credit facility
—
(250.0
)
Repurchases of common stock
(107.1
)
(11.3
)
Net proceeds from issuance of common stock
under share-based compensation arrangements
2.8
10.2
Other
(1.3
)
(1.3
)
Net cash used in financing
activities
(138.2
)
(252.4
)
Effect of exchange rate changes on cash
and cash equivalents and restricted cash
(13.2
)
(1.4
)
Net change in cash and cash equivalents
and restricted cash
(367.8
)
179.0
Cash and cash equivalents and
restricted cash at beginning of period
2,723.6
1,367.3
Cash and cash equivalents and
restricted cash at end of period
$
2,355.8
$
1,546.3
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200506005293/en/
Alexion: Media Megan
Goulart, 857-338-8634 Senior Director, Corporate Communications
Investors Chris Stevo, 857-338-9309 Head of Investor
Relations
Alexion Pharmaceuticals (NASDAQ:ALXN)
Historical Stock Chart
From Apr 2024 to May 2024
Alexion Pharmaceuticals (NASDAQ:ALXN)
Historical Stock Chart
From May 2023 to May 2024