- 1Q19 total revenues of $1,140.4
million, a 23 percent increase over 1Q18 and a 26 percent volume
increase
- 1Q19 GAAP diluted EPS of $2.61;
non-GAAP diluted EPS of $2.39
- Strong U.S. launch underway for
ULTOMIRIS® (ravulizumab-cwvz) in adults with paroxysmal noctural
hemoglobinuria (PNH); PNH applications under review in EU and
Japan; U.S. filing submitted for atypical hemolytic uremic syndrome
(aHUS)
- SOLIRIS® (eculizumab) for neuromyelitis
optica spectrum disorder (NMOSD) granted Priority Review by U.S.
FDA with action date of June 28, 2019; EU and Japanese applications
under review
- Announced collaborations with Caelum
Biosciences, Affibody and Zealand Pharma
- Total Revenues and EPS guidance
increased to reflect strength of the business and continued
growth
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced
financial results for the first quarter of 2019. Total revenues in
the first quarter were $1,140.4 million, a 23 percent increase
compared to the same period in 2018. The negative impact of foreign
currency on total revenues year-over-year was 1 percent, or $12.3
million, inclusive of hedging activities. On a GAAP basis, diluted
EPS in the quarter was $2.61, a 135 percent increase versus the
prior year. Non-GAAP diluted EPS for the first quarter of 2019 was
$2.39, a 42 percent increase versus the first quarter of 2018.
"We had a great start to 2019, with a strong launch in
ULTOMIRIS' first full quarter since FDA approval. We've also made
significant progress executing and expanding our pipeline. This
progress includes three business development deals, multiple
filings under regulatory review and having begun dosing patients in
two new ULTOMIRIS Phase 3 programs," said Ludwig Hantson, Ph.D.,
Chief Executive Officer of Alexion. "We look forward to continuing
to build on our momentum as the year progresses, further growing
our four durable franchises in hematology/nephrology, neurology,
metabolics and FcRn."
First Quarter 2019 Financial
Highlights
- Total net product sales were $1,140.2
million in the first quarter of 2019, compared to $930.4 million in
the first quarter of 2018.
- SOLIRIS® (eculizumab) net product sales
were $962.0 million, compared to $800.1 million in the first
quarter of 2018, representing a 20 percent increase. SOLIRIS volume
increased 23 percent year-over-year.
- ULTOMIRIS® (ravulizumab-cwvz) net
product sales were $24.6 million in its first full quarter since
FDA approval.
- STRENSIQ® (asfotase alfa) net product
sales were $130.1 million, compared to $110.7 million in the first
quarter of 2018, representing an 18 percent increase. STRENSIQ
volume increased 26 percent year-over-year.
- KANUMA® (sebelipase alfa) net product
sales were $23.5 million, compared to $19.6 million in the first
quarter of 2018, representing a 20 percent increase. KANUMA volume
increased 28 percent year-over-year.
- GAAP cost of sales was $85.8 million,
compared to $91.6 million in the first quarter of 2018. Non-GAAP
cost of sales was $82.1 million, compared to $83.0 million in the
first quarter of 2018.
- GAAP R&D expense was $195.9
million, compared to $176.6 million in the first quarter of 2018.
Non-GAAP R&D expense was $159.4 million, compared to $161.6
million in the first quarter of 2018.
- GAAP SG&A expense was $281.5
million, compared to $257.1 million in the first quarter of 2018.
Non-GAAP SG&A expense was $243.7 million, compared to $220.4
million in the first quarter of 2018.
- GAAP income tax benefit was $46.1
million, compared to income tax expense of $102.5 million in the
first quarter of 2018. GAAP income tax benefit for the first
quarter 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 $100.9
million, compared to $68.6 million in the first quarter of
2018.
- GAAP diluted EPS was $2.61, compared to
$1.11 in the first quarter of 2018. GAAP diluted EPS for the first
quarter 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 $2.39, compared
to $1.68 in the first quarter of 2018.
Research and
DevelopmentPHASE 3
- SOLIRIS - Neuromyelitis Optica
Spectrum Disorder (NMOSD): In February 2019, Alexion announced
that the U.S. Food and Drug Administration (FDA) granted Priority
Review for SOLIRIS in NMOSD and set a Prescription Drug User Fee
Act (PDUFA) action date of June 28, 2019. Alexion has filed for
regulatory approval in the European Union (EU) and Japan, and
orphan drug priority review has been granted in Japan. These
filings are based on previously announced results from the Phase 3
PREVENT study, in which 97.9 percent of patients with
anti-aquaporin-4 (AQP4) auto antibody-positive NMOSD who received
SOLIRIS on top of stable standard-of-care therapy were relapse free
at 48 weeks compared to 63.2 percent of patients who received
placebo.
- ULTOMIRIS - Paroxysmal Nocturnal
Hemoglobinuria (PNH): Applications for approval in the EU and
Japan are currently under review. In addition, a Phase 3 study of
ULTOMIRIS in children and adolescents with PNH is underway.
- ULTOMIRIS - Atypical
Hemolytic Uremic Syndrome (aHUS): In April 2019, Alexion
submitted an application in the U.S. for the approval of ULTOMIRIS
in patients with aHUS. The filing was based on previously announced
positive topline results from a Phase 3 study of ULTOMIRIS in
complement inhibitor naïve patients with aHUS. Alexion plans to
file for regulatory approval in the EU and Japan in 2019. In
addition, a Phase 3 study of ULTOMIRIS in adolescents and children
with aHUS is underway.
- ULTOMIRIS - Subcutaneous:
Enrollment and dosing are underway 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 early
2020.
- ULTOMIRIS - Generalized
Myasthenia Gravis (gMG): In the first quarter of 2019, Alexion
initiated a Phase 3 study of ULTOMIRIS in gMG.
- ULTOMIRIS - Neuromyelitis
Optica Spectrum Disorder (NMOSD): Alexion plans to initiate a
Phase 3 study of ULTOMIRIS in NMOSD by the end of 2019.
- ALXN1840 (WTX101) - Wilson
Disease: Enrollment and dosing are underway in a Phase 3 study
of ALXN1840 (WTX101) in Wilson disease, a rare genetic disorder
with devastating hepatic and neurological consequences. The study
is now powered for superiority versus standard-of-care therapy.
ALXN1840 is a first-in-class oral copper-binding agent with a
unique mechanism of action to bind serum copper and promote its
removal from the liver.
PHASE 1/2
- ALXN1830 (SYNT001): Alexion
plans to initiate two Phase 2/3 trials of ALXN1830 (SYNT001) in
late 2019 or early 2020 - one in warm autoimmune hemolytic anemia
(WAIHA) and one in gMG.
- ALXN1810 - Subcutaneous: In the
first quarter of 2019, Alexion completed dosing in a Phase 1 study
of subcutaneous ALXN1210 co-administered with Halozyme's ENHANZE®
drug-delivery technology, recombinant human hyaluronidase enzyme
(rHuPH20), a next-generation subcutaneous formulation called
ALXN1810.
- ULTOMIRIS - Amyotrophic
Lateral Sclerosis (ALS): Alexion plans to initiate a
proof-of-concept study for ULTOMIRIS in ALS.
- ULTOMIRIS - Primary
Progressive Multiple Sclerosis (PPMS): Alexion plans to
initiate an exploratory clinical study of ULTOMIRIS in PPMS.
- Caelum Biosciences - CAEL-101
- Light Chain (AL) Amyloidosis: In January 2019, Alexion
entered into a collaboration with Caelum Biosciences to develop
CAEL-101 for AL amyloidosis, a rare systemic disorder that causes
misfolded immunoglobulin light chain protein to build up in and
around tissues, resulting in progressive and widespread organ
damage. CAEL-101 is a first-in-class amyloid fibril targeted
therapy designed to improve organ function by reducing or
eliminating amyloid deposits in patients with AL amyloidosis. In a
Phase 1a/1b study, CAEL-101 demonstrated improved organ function,
including cardiac and renal function, in patients with relapsed and
refractory AL amyloidosis. Pending regulatory feedback, a Phase 2/3
study investigating CAEL-101 as an add-on to current
standard-of-care therapy is planned to begin in early 2020.
- Affibody AB - ABY-039: In March
2019, Alexion announced a partnership with Affibody AB to
co-develop ABY-039 for rare Immunoglobulin G (IgG)-mediated
autoimmune diseases. Pending relevant regulatory approvals, the
transaction is expected to close in the second quarter of 2019.
Currently in Phase 1 development, ABY-039 is a bivalent
antibody-mimetic that targets the neonatal Fc receptor (FcRn).
ABY-039 has been specifically designed to combine Affibody's
protein therapeutics platform (Affibody® molecules) and Albumod™
technology to achieve a long half-life, which, along with its small
size provides the potential for less frequent, convenient, at-home
subcutaneous administration.
PRE-CLINICAL
- ALXN1720: In March 2019, Alexion
announced the development of ALXN1720, a novel anti-C5
albumin-binding bi-specific mini-body that binds and prevents
activation of human C5. Alexion plans to initiate a first-in-human
study of ALXN1720 in late 2019.
- Zealand Pharma A/S: In March
2019, Alexion began a collaboration with Zealand Pharma A/S to
discover and develop novel peptide therapies for up to four targets
in the complement pathway. Peptides offer a number of advantages,
including being highly selective and potent, allowing low dosage
volumes for ease of administration, and having the potential to
treat a broad range of complement-mediated diseases.
- Dicerna - GalXC™: Alexion is
collaborating with Dicerna Pharmaceuticals to jointly discover and
develop up to four subcutaneously delivered GalXC™ RNA interference
(RNAi) candidates, currently in pre-clinical development, for the
treatment of complement-mediated diseases.
- Complement Pharma - CP010:
Alexion is collaborating with Complement Pharma to co-develop
CP010, a pre-clinical C6 inhibitor that has the potential to treat
multiple neurological disorders.
2019 Financial Guidance
Alexion is increasing total revenues and EPS guidance. Full
guidance updates are outlined below.
Previous Updated Total revenues $4,625 to $4,700
million $4,675 to $4,750 million SOLIRIS/ULTOMIRIS revenues $3,970
to $4,020 million $4,020 to $4,070 million Metabolic revenues $655
to $680 million $655 to $680 million R&D (% total revenues)
GAAP 17% to 18% 19% to 20% Non-GAAP 16% to 17% 16% to 17% SG&A
(% total revenues) GAAP 23% to 24% 23% to 24% Non-GAAP 20% to 21%
20% to 21% Operating margin GAAP 36% to 43% 35% to 42% Non-GAAP 54%
to 55% 54% to 55% Earnings per share GAAP $6.14 to $7.26 $6.76 to
$7.96 Non-GAAP $9.10 to $9.30 $9.25 to $9.45
Updated 2019 financial guidance assumes the following:
- GAAP guidance reflects the financial
impact of the announced collaboration with Affibody.
- GAAP effective tax rate of 7 to 9
percent; non-GAAP effective tax rate of 14 to 16 percent.
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 collaboration agreements,
intangible asset impairments, litigation charges, changes in fair
value of contingent consideration 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 2019 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 1692605 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
therapies. 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), as well as the
first and only approved complement inhibitor to treat atypical
hemolytic uremic syndrome (aHUS) and anti-acetylcholine receptor
(AchR) antibody-positive generalized myasthenia gravis (gMG), and
is also developing it for patients with 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
second complement inhibitor, a copper-binding agent for Wilson
disease and an anti-neonatal Fc receptor (FcRn) antibody for rare
Immunoglobulin G (IgG)-mediated diseases as well as several
early-stage therapies, including one for light chain (AL)
amyloidosis and a second anti-FcRn therapy. 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 and metabolic disorders.
Alexion has been named to the Forbes list of the World’s Most
Innovative Companies seven years in a row and is headquartered in
Boston, Massachusetts’ Innovation District. The company also 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 2019 (and the assumptions related to such
guidance); the strength of our business and continued growth; plans
to expand the Company's pipeline; Company's goal of continuing to
build on momentum as the year progresses; further future growth in
the Company's four durable franchises (hematology/nephrology,
metabolics, neurology and FcRn); plans to make future regulatory
submissions/filings for approval of certain of our products and
product candidates, including SOLIRIS (eculizumab) and ULTOMIRIS
(ALXN1210/ravulizumab-cwvz), and the expected timing related
thereto, (as well as the expected timing of the receipt of certain
regulatory approvals to market a product); 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; potential benefits of current products and
products under development and in clinical trials (including
further extended dosing intervals); Company’s plans to initiate
proof-of-concept studies for ULTOMIRIS in ALS and exploratory
clinical study for ULTOMIRIS in PPMS; the expected timing of the
closing of the Affibody AB transaction; the potential to treat a
broad range of complement mediated diseases with the product to be
developed with Zealand Pharma A/S; and Alexion's future clinical,
regulatory, and commercial plans for ULTOMIRIS and other 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 PNH patients (and
any future indications) from SOLIRIS to ULTOMIRIS; payer, physician
and patient acceptance of ULTOMIRIS as an alternative to SOLIRIS;
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, HPP and LAL-D and other future 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 Syntimmune and other 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, 2018 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. The non-GAAP results
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 collaborations, acquired in-process
research and development assets, impairment of intangible assets,
change in value of strategic equity investments, litigation
charges, gain or loss on sale of a business or asset 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 2019 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, 2019 and 2018 and projected twelve months
ending December 31, 2019.
(Tables Follow)
ALEXION PHARMACEUTICALS, INC. TABLE 1: CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS (in millions, except
per share amounts) (unaudited)
Three months ended March
31 2019 2018 Net product sales $
1,140.2 $ 930.4 Other revenue 0.2 0.5 Total revenues
1,140.4 930.9 Cost of sales 85.8 91.6 Operating expenses:
Research and development 195.9 176.6 Selling, general and
administrative 281.5 257.1 Amortization of purchased intangible
assets 80.0 80.0 Change in fair value of contingent consideration
(28.7 ) 52.7 Restructuring expenses 9.1 5.5 Total
operating expenses 537.8 571.9 Operating
income 516.8 267.4 Other income and expense: Investment
income 42.5 105.8 Interest expense (19.9 ) (24.1 ) Other income and
(expense) 2.4 2.5 Income before income taxes
541.8 351.6 Income tax (benefit) expense (46.1 ) 102.5
Net income $ 587.9 $ 249.1 Earnings per
common share Basic $ 2.63 $ 1.12 Diluted $ 2.61 $ 1.11
Shares used in computing earnings per common share Basic 223.8
222.1 Diluted 225.5 223.7
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
2019 2018 GAAP net income $ 587.9 $
249.1 Before tax adjustments: Cost of sales: Share-based
compensation 3.7 3.3 Restructuring related expenses (1) — 5.3
Research and development expense: Share-based compensation 15.3
14.9 Upfront payments related to licenses and collaborations (2)
21.2 — Restructuring related expenses (1) — 0.1 Selling, general
and administrative expense: Share-based compensation 37.7 33.1
Restructuring related expenses (1) — 3.6 Litigation charges 0.1 —
Amortization of purchased intangible assets 80.0 80.0 Change in
fair value of contingent consideration (3) (28.7 ) 52.7
Restructuring expenses (1) 9.1 5.5 Investment income: Change in
value of strategic equity investments (4) (33.8 ) (100.8 ) Other
income: Restructuring related expenses (1) — (0.1 ) Adjustments to
income tax expense (5) (147.0 ) 33.9 Non-GAAP net income $
545.5 $ 380.6 GAAP earnings per common share -
diluted $ 2.61 $ 1.11 Non-GAAP earnings per common share - diluted
$ 2.39 $ 1.68
Shares used in computing diluted earnings
per common share (GAAP)
225.5 223.7
Shares used in computing diluted earnings
per common share (non-GAAP)
228.1 226.4
(1) The following table summarizes the total restructuring and
related expenses recorded by type of activity and the
classification within the Reconciliation of GAAP to non-GAAP
Financial Results:
Three months ended
March 31, Three months ended March 31, 2019
2018
Employee Separation
Costs
Asset-Related
Charges
Other Total
Employee Separation
Costs
Asset-Related
Charges
Other Total Cost of sales $ — $ — $ —
$ — $ — $ 5.3 $ — $ 5.3
Research anddevelopment
— —
— — — 0.1 — 0.1
Selling, general andadministrative
— — — —
—
3.6 — 3.6 Restructuring expense 9.1 — — 9.1
1.0 — 4.5 5.5 Other (income) expense — —
—
— — — (0.1 ) (0.1 ) $ 9.1
$ — $ — $ 9.1 $
1.0 $ 9.0 $ 4.4 $ 14.4
(2) We recorded an upfront license payment of
$21.2 million in connection with an agreement that we entered into
with Zealand Pharma A/S in March 2019. (3) For the three
months ended March 31, 2019 and 2018, changes in the fair value of
contingent consideration reflect the impact of changes in the
expected timing of payments of contingent consideration. Changes in
the fair value of contingent consideration for the three months
ended March 31, 2018 also included the impact of changes in the
probability of achieving the contingent milestones. (4) Our
investments include strategic equity investments in Moderna
Therapeutics, Inc., Dicerna Pharmaceuticals, Inc. and Zealand
Pharma A/S which are recorded at fair value. During the three
months ended March 31, 2019, we recognized an unrealized gain of
$33.8 million in investment income to adjust our strategic equity
investments to fair value. During the three months ended March 31,
2018, we recognized an unrealized gain of $100.8 million to adjust
our investment in Moderna Therapeutics, Inc. to fair value.
(5) Alexion's non-GAAP income tax expense for the three months
ended March 31, 2019 and 2018 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
Therapeutics AB and a release of an existing valuation allowance,
respectively. Non-GAAP income tax expense for the three months
ended March 31, 2018 also excludes adjustments to provisional
estimates of the impact of Tax Cuts and Jobs Act we recorded in
fourth quarter 2017.
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, 2019 Low
High GAAP net income $ 1,532 $ 1,804 Before
tax adjustments: Share-based compensation 256 239 Upfront payments
related to licenses and collaborations 46 46 Acquired in-process
research and development 240 — Amortization of purchased intangible
assets 320 320 Change in fair value of contingent consideration (15
) (15 ) Restructuring expenses 25 20 Change in value of strategic
equity investments (34 ) (34 ) Adjustments to income tax expense
(252 ) (216 ) Non-GAAP net income $ 2,118 $ 2,164
Diluted GAAP earnings per common share $ 6.76 $ 7.96 Diluted
non-GAAP earnings per common share $ 9.25 $ 9.45 Operating
expense and margin (% total revenues) GAAP research and
development expense 20 % 19 % Share-based compensation 2 % 2 %
Upfront payments related to licenses and collaborations 1 % 1 %
Non-GAAP research and development expense 17 % 16 % GAAP
selling, general and administrative expense 24 % 23 % Share-based
compensation 3 % 3 % Non-GAAP selling, general and administrative
expense 21 % 20 % GAAP operating margin 35 % 42 %
Share-based compensation 5 % 5 % Upfront payments related to
licenses and collaborations 1 % 1 % Acquired in-process research
and development 5 % — % Amortization of purchased intangible assets
7 % 7 % Change in fair value of contingent consideration 0 % 0 %
Restructuring expenses 1 % 0 % Non-GAAP operating margin 54 % 55 %
Income tax expense (% of income before income taxes)
GAAP income tax expense 9 % 7 %
Tax effect of pre-tax adjustments to GAAP
net income and other one-time itemsassociated with intellectual
property
7 % 7 % Non-GAAP income tax expense 16 % 14 %
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 2019
2018
SOLIRIS
United States $ 463.7 $ 336.0 Europe 264.5 250.8 Asia Pacific 100.9
85.5 Rest of World 132.9 127.8 Total Soliris $ 962.0
$ 800.1
ULTOMIRIS
United States $ 24.6 $ — Europe — — Asia Pacific — — Rest of World
— — Total Ultomiris $ 24.6 $ —
STRENSIQ
United States $ 99.5 $ 89.2 Europe 17.5 14.0 Asia Pacific 9.9 5.7
Rest of World 3.2 1.8 Total Strensiq $ 130.1 $ 110.7
KANUMA
United States $ 13.8 $ 11.9 Europe 6.3 5.9 Asia Pacific 0.8 1.0
Rest of World 2.6 0.8 Total Kanuma $ 23.5 $ 19.6
Net Product
Sales
United States $ 601.6 $ 437.1 Europe 288.3 270.7 Asia Pacific 111.6
92.2 Rest of World 138.7 130.4 Total Net Product Sales $
1,140.2 $ 930.4
ALEXION PHARMACEUTICALS,
INC. TABLE 5: CONDENSED CONSOLIDATED BALANCE SHEETS
(in millions) (unaudited)
March
31
December 31 2019 2018 Cash and cash
equivalents $ 1,544.8 $ 1,365.5 Marketable securities 110.3 198.3
Trade accounts receivable, net 1,016.3 922.3 Inventories 482.2
472.5 Prepaid expenses and other current assets (1) 497.0 426.4
Property, plant and equipment, net (1) 1,095.7 1,471.5 Intangible
assets, net 3,560.8 3,641.3 Goodwill 5,037.4 5,037.4 Right of use
operating assets (1) 192.8 — Other assets 462.3 396.7 Total
assets $ 13,999.6 $ 13,931.9 Accounts payable and
accrued expenses $ 669.8 $ 698.2 Revolving credit facility — 250.0
Current portion of long-term debt 126.5 93.8 Current portion of
contingent consideration 97.6 97.6 Other current liabilities (1)
49.9 34.4 Long-term debt, less current portion 2,470.0 2,501.7
Contingent consideration 154.5 183.2 Facility lease obligations (1)
— 361.0 Deferred tax liabilities 306.1 391.1 Noncurrent operating
lease liabilities (1) 150.8 — Other liabilities (1) 267.8 155.6
Total liabilities 4,293.0 4,766.6 Total stockholders' equity
(1) 9,706.6 9,165.3 Total liabilities and stockholders'
equity $ 13,999.6 $ 13,931.9 (1) In February
2016, the Financial Accounting Standards Board issued a new
standard that requires lessees to recognize leases on-balance
sheet. We adopted the new standard on January 1, 2019 using the
modified retrospective approach. The March 31, 2019 condensed
consolidated balance sheet is presented under the new standard,
while the December 31, 2018 condensed consolidated balance sheet is
not adjusted and continues to be reported under the accounting
standards in effect for that period. Upon adoption of the new lease
standard, we derecognized $472.8 million of property, plant and
equipment and other assets and $372.2 million of facility lease
obligations associated with previously existing build-to-suit
arrangements which resulted in a decrease of $90.3 million to
retained earnings, net of tax. In addition, we capitalized $326.1
million and $255.3 million of right of use assets and lease
liabilities, respectively, within our condensed consolidated
balance sheet upon adoption.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190425005264/en/
Alexion:MediaMegan
Goulart, 857-338-8634Senior Director, Corporate Communications
InvestorsSusan Altschuller, Ph.D., 857-338-8788Vice
President, Investor Relations
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