Alexion Reports First Quarter 2009 Results
Continued Steady Uptake of Soliris(R) For New PNH Patients in U.S. and
EuropeSoliris Being Evaluated in Five Severe and Rare Disorders2009 Guidance ReiteratedFirst Quarter 2009 Financial Highlights:
Soliris(R) (eculizumab) net product sales were $81.3 million in Q1 2009,
compared to net product sales of $45.5 million in Q1 2008.
Q1 GAAP net income was $14.5 million, or $0.16 per share, compared to
a GAAP net loss of $4.2 million, or $0.06 per share, in Q1 2008.
Q1 non-GAAP net income was $22.4 million, or $0.25 per share, compared
to non-GAAP net income of $1.6 million, or $0.02 per share, in Q1 2008.
CHESHIRE, Conn., Apr 23, 2009 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial
results for the quarter ended March 31, 2009.
First Quarter 2009 Financial Results:
For the three months ended March 31, 2009, Alexion Pharmaceuticals, Inc.
("Alexion" or the "Company") reported net product sales of Soliris(R) of
$81.3 million, compared to $45.5 million for the same period in 2008.
Soliris was approved in the United States and European Union in 2007 and
is the only drug specifically indicated for the treatment of patients
with paroxysmal nocturnal hemoglobinuria ("PNH"), an ultra-rare,
debilitating and life-threatening blood disease.
The Company reports both GAAP and non-GAAP results. Non-GAAP results are
equal to GAAP results excluding the impact of share-based compensation
expense. The following summary table is provided for investors'
convenience. A further reconciliation and explanation of the GAAP to
non-GAAP figures appears at the end of this announcement.
| | |
(In millions, except per-share data)
| | |
| | Quarter Ended March 31, |
| | 2009 | | 2008 |
|
Net Product Sales
| |
$
|
81.3
| |
$
|
45.5
| |
|
Contract Revenues
| |
$
|
0.0
| |
$
|
0.1
| |
|
Total Revenues
| |
$
|
81.3
| |
$
|
45.6
| |
| | | | |
|
GAAP Net Income (Loss)
| | |
14.5
| | |
(4.2
|
)
|
|
Share-Based Compensation
| | |
7.9
| | |
5.9
| |
|
Non-GAAP Net Income
| |
$
|
22.4
| |
$
|
1.6
| |
| | | | |
GAAP Net Income (Loss) Per
Share - Diluted
| |
$
|
0.16
| |
$
|
(0.06
|
)
|
Non-GAAP Net Income Per
Share - Diluted
| |
$
|
0.25
| |
$
|
0.02
| |
Shares Used in Determining
GAAP Income (Loss) Per Share
| | |
90.6
| | |
75.0
| |
Shares Used in Determining
Non-GAAP Income Per Share
| | |
91.9
| | |
78.2
| |
First Quarter 2009 Non-GAAP Financial
Results
The Company reported non-GAAP net income for Q1 2009 of $22.4 million,
or $0.25 per share, compared to non-GAAP net income of $1.6 million, or
$0.02 per share, in Q1 2008.
Alexion's non-GAAP operating expenses for Q1 2009 were $47.8 million,
compared to $39.5 million for Q1 2008. Non-GAAP research and development
("R&D") expenses for Q1 2009 were $16.9 million, compared to $14.0
million for Q1 2008. The increase in R&D expenses in Q1 2009 is
primarily the result of the expansion of the Company's research and
development programs. Non-GAAP selling, general and administrative
("SG&A") expenses for Q1 2009 were $31.0 million, compared to $25.5
million for Q1 2008. The increase in non-GAAP SG&A expenses is primarily
due to costs associated with the expansion of the Company's commercial
operations in the U.S., Europe, Asia-Pacific and Japan.
First Quarter 2009 GAAP Financial Results
On a GAAP basis, operating expenses for Q1 2009 were $55.7 million,
compared to $45.4 million for Q1 2008. R&D expenses for Q1 2009 were
$19.1 million, compared to $15.6 million for Q1 2008. The increase in
R&D expenses in Q1 2009 is primarily the result of the expansion of the
Company's research and development programs. SG&A expenses were $36.7
million for Q1 2009, compared to $29.8 million for Q1 2008. The increase
in GAAP SG&A expenses is primarily due to costs associated with the
expansion of the Company's commercial operations in the U.S., Europe,
Asia-Pacific and Japan. Operating expenses for Q1 2009 included $7.9
million of share-based compensation expense, compared to $5.9 million in
Q1 2008.
Alexion reported GAAP net income for the first quarter of 2009 of $14.5
million, or $0.16 per share, compared to a GAAP net loss of $4.2
million, or $0.06 per share, for Q1 2008.
Balance Sheet:
At March 31, 2009, the Company had $140.8 million in cash, cash
equivalents, restricted cash and marketable securities, compared to
$139.7 million at December 31, 2008. The outstanding balance on the
Company's $25 million revolving credit facility remained at zero
throughout the first quarter.
"In the first quarter, in the U.S. and Europe, we provided the clinical
benefits of Soliris to significant numbers of new patients. We observed
increased awareness among physicians regarding PNH and its treatment
options, combined with continued efficient access to Soliris for
patients," said Leonard Bell, M.D., Chief Executive Officer of Alexion.
"Our steady growth and strong financial position enable us to make the
necessary investments to provide the innovative complement-inhibition
technology of Soliris to more patients with PNH in more countries, while
progressing our pipeline programs to help patients with other severe and
ultra-rare disorders."
Expanding Access to Soliris for Patients with PNH in Additional
Countries:
As previously announced, during Q1, Alexion reached important regulatory
milestones in the geographic expansion of patient access to Soliris:
-
In Japan, Soliris received orphan drug designation in January, and the
Company submitted a New Drug Application for Soliris to the Japanese
healthcare authorities at the end of March.
-
In Canada, Health Canada approved Soliris with the same broad label
that has helped patients to gain access to Soliris in the U.S. and
Europe.
-
In Australia, the Therapeutic Goods Administration approved Soliris in
February.
Pipeline:
Soliris as an Investigational Treatment
for Patients with Other Ultra-Rare and Severe Diseases
With the FDA approval in 2007 of Soliris as a treatment for patients
with PNH, a complement-inhibitor deficiency disease, Alexion became the
first company to discover and then develop a terminal complement
inhibitor into a commercial product. The Company is currently developing
clinical programs to investigate the use of Soliris as a treatment for
patients with other complement-inhibitor deficiency diseases, as well as
those with other severe, complement-mediated conditions.
Clinical studies are being initiated in patients with two other
ultra-rare, severe complement-inhibitor deficiency diseases: atypical
hemolytic uremic syndrome (aHUS) and dense deposit disease, two diseases
in which the lack of naturally occurring complement inhibitors can cause
life-threatening kidney damage. Patient enrollment is continuing in a
study of kidney transplant patients who are known to have a higher risk
of organ rejection. Top-line data on the first cohort of these
transplant patients is expected to be presented at the American
Transplant Congress this spring.
In neurology, patients are being enrolled in a clinical study of Soliris
as a treatment for patients with a resistant form of myasthenia gravis
(MG), an ultra-rare, disabling and sometimes life-threatening
complement-mediated neurologic disorder. In addition, patient dosing has
commenced in an investigator-sponsored clinical trial evaluating the use
of Soliris in patients with a second debilitating and ultra-rare
neurologic disease, multifocal motor neuropathy.
Oncology Program
Patient enrollment and dosing is continuing in a Phase I/II study of
Alexion's novel, first-in-class humanized anti-CD200 monoclonal
antibody, in patients with chronic lymphocytic leukemia (CLL). The
Company plans to expand the investigation of its anti-CD200 antibody for
patients with other cancers, particularly those with multiple myeloma,
in the latter part of the year.
2009 Financial Guidance:
The Company is reiterating the 2009 financial guidance announced in
February. Worldwide net product sales are expected to be within a range
of $360 to $375 million. Gross margin is expected to be in the range of
87 to 89 percent. Excluding share-based compensation, R&D expenses in
2009 are anticipated to be in the range of $80 to $85 million, and
selling, general and administrative expenses in the range of $140 to
$150 million. The Company's share-based compensation expense for the
year is expected to be in a range of approximately $28 to $30 million.
Taxes on non-GAAP income are expected to be in a range of five percent
to seven percent. Alexion is reiterating guidance of $1.00 to $1.05 for
non-GAAP diluted earnings per share for the year.
Conference Call/Web Cast Information
Alexion will host a conference call/webcast to discuss matters mentioned
in this release. The call is scheduled for today, April 23, 2009, at
10:00 a.m., Eastern Time. To participate in this call, dial
719-325-4871, confirmation code 4042547, shortly before 10:00 a.m.,
Eastern Time. A replay of the call will be available for a limited
period following the call, beginning at 1:00 p.m. Eastern Time. The
replay number is 719-457-0820, confirmation code 4042547. The audio
webcast can be accessed at www.alexionpharm.com.
About Soliris
Soliris has been approved by the U.S. Food and Drug Administration
(March 2007), the European Commission (June 2007), Health Canada
(January 2009) and Australia's Therapeutic Goods Administration
(February 2009) as the first treatment for all patients with PNH, an
ultra-rare, debilitating and life-threatening blood disorder defined by
hemolysis, or the destruction of red blood cells. All four jurisdictions
reviewed and approved their respective marketing applications for
Soliris under their priority review or accelerated assessment
procedures, and all four have designated Soliris as an orphan drug.
In patients with PNH, hemolysis can cause life-threatening thromboses,
recurrent pain, kidney disease, disabling fatigue, impaired quality of
life, severe anemia, pulmonary hypertension, shortness of breath and
intermittent episodes of dark-colored urine (hemoglobinuria). Soliris,
or eculizumab, is the only treatment that blocks this hemolysis. Prior
to these approvals, there were no therapies specifically available for
the treatment of PNH. PNH treatment was limited to symptom management
through periodic blood transfusions, non-specific immunosuppressive
therapy and, infrequently, bone marrow transplantations -- a procedure
that carries its own substantial risks of mortality and morbidity.
Alexion is committed to the objective that every patient with PNH who
can benefit from Soliris will have access to Soliris.
About Alexion
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to
develop and deliver life-changing drug therapies for patients with
serious and life-threatening medical conditions. Alexion is engaged in
the discovery, development and commercialization of therapeutic products
aimed at treating patients with a wide array of severe disease states,
including hematologic and kidney diseases, transplant, cancer, and
autoimmune disorders. Soliris is Alexion's first marketed product,
approved in the U.S. and Europe in 2007, and Canada and Australia in
2009. Alexion is evaluating other potential indications for Soliris as
well as other formulations of eculizumab for additional clinical
indications, and is pursuing development of other antibody product
candidates in early stages of development. This press release and
further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com.
This press release includes certain non-GAAP financial measures that
involve adjustments to GAAP figures. Alexion believes that these
non-GAAP financial measures, when considered together with the GAAP
figures, can enhance an overall understanding of Alexion's past
financial performance and its prospects for the future. The non-GAAP
financial measures are included with the intent of providing both
management and investors with a more complete understanding of
underlying operational results and trends. In addition, these non-GAAP
financial measures are among the primary indicators Alexion management
uses for planning and forecasting purposes and measuring the company's
performance. These non-GAAP financial measures are not intended to be
considered in isolation or as a substitute for GAAP figures. A
reconciliation of the non-GAAP to GAAP figures follows this press
release.
[ALXN-E]
This news release contains forward-looking statements, including
statements related to guidance regarding anticipated financial results
for 2009, assessment of the Company's growth, financial position and
commercialization efforts; potential benefits and commercial potential
for Soliris; expectations with respect to timing of presenting clinical
data in non-PNH indications; potential of Alexion's
complement-inhibition technology for treatment of diseases other than
PNH; plans for expansion of clinical programs for CD200 and Soliris in
non-PNH indications; progress in developing commercial infrastructure;
interest about Soliris in the patient, physician and payor communities;
awareness of PNH and its treatment options among physicians; and
assessment of patient access. Forward-looking statements are subject to
factors that may cause Alexion's results and plans to differ from those
expected, including for example, decisions of regulatory authorities
regarding marketing approval or material limitations on the marketing of
Soliris, delays in arranging satisfactory manufacturing capability and
establishing commercial infrastructure, delays in developing or adverse
changes in commercial relationships, the possibility that results of
clinical trials are not predictive of safety and efficacy results of
Soliris in broader patient populations, the possibility that initial
results of commercialization are not predictive of future rates of
adoption of Soliris, the risk that third parties won't agree to license
any necessary intellectual property to us on reasonable terms or at all,
the risk that third party payors (including governmental agencies) will
not reimburse for the use of Soliris at acceptable rates or at all, the
risk that estimates regarding the number of PNH patients are inaccurate,
the possibility that Alexion will not be able to expand the use of
Soliris into new markets and for new indications, the risk that Alexion
will not be able to successfully complete clinical and preclinical
programs for its new product candidates, including CD200 and a variety
of other risks set forth from time to time in Alexion's filings with the
Securities and Exchange Commission, including but not limited to the
risks discussed in Alexion's Annual Report on Form 10-K for the period
ended December 31, 2008 and in our other filings with the Securities and
Exchange Commission. Alexion does not intend to update any of these
forward-looking statements to reflect events or circumstances after the
date hereof, except when a duty arises under law.
| | | | |
ALEXION PHARMACEUTICALS, INC. Selected Financial Data
(Unaudited)
(Amounts in thousands, except per share amounts)
|
| | | | |
| Consolidated Statements of Operations Data: | | Three Months Ended |
| | March 31 |
| | | 2009 | | | | 2008 | |
|
Revenues:
| | | | |
|
Net product sales
| |
$
|
81,267
| | |
$
|
45,546
| |
|
Contract research revenues
| | |
-
| | | |
95
| |
|
Total revenues
| | |
81,267
| | | |
45,641
| |
| | | | |
|
Cost of sales
| | |
9,959
| | | |
5,464
| |
| | | | |
|
Operating expenses:
| | | | |
|
Research and development
| | |
19,089
| | | |
15,609
| |
|
Selling, general and administrative
| | |
36,652
| | | |
29,781
| |
|
Total operating expenses
| | |
55,741
| | | |
45,390
| |
| | | | |
|
Operating income (loss)
| | |
15,567
| | | |
(5,213
|
)
|
| | | | |
|
Other income (expense):
| | | | |
|
Investment income
| | |
303
| | | |
767
| |
|
Interest expense
| | |
(333
|
)
| | |
(596
|
)
|
|
Foreign currency gain(loss)
| | |
(393
|
)
| | |
703
| |
| | |
(423
|
)
| | |
874
| |
| | | | |
|
Income tax provision (benefit)
| | |
638
| | | |
(90
|
)
|
| | | | |
|
Net income (loss)
| |
$
|
14,506
| | |
$
|
(4,249
|
)
|
| | | | |
|
Net income (loss) per share
| | | | |
|
basic
| |
$
|
0.18
| | |
$
|
(0.06
|
)
|
|
diluted
| |
$
|
0.16
| | |
$
|
(0.06
|
)
|
| | | | |
|
Shares used in computing net income (loss) per common share
| | | | |
|
basic
| | |
81,698
| | | |
75,028
| |
|
diluted
| | |
90,645
| | | |
75,028
| |
| | | | |
| Consolidated Balance Sheet Data: | | As of |
| | March 31, 2009 | | December
31, 2008 |
|
Cash, cash equivalents and marketable securities (a)
| |
$
|
140,809
| | |
$
|
139,711
| |
|
Total assets
| | |
488,794
| | | |
477,551
| |
|
Total stockholders' equity
| | |
274,711
| | | |
247,001
| |
| | | | |
(a) Amount includes restricted cash of $1,770 and $1,699 at March
31, 2009 and December 31, 2008, respectively.
|
| | | | | | |
ALEXION PHARMACEUTICALS, INC. Selected Financial Data
(Unaudited)
(Amounts in thousands, except per share amounts)
|
| | | | | | |
Non-GAAP financial information is adjusted to exclude the impact
of share-based compensation expense.
The following table represents a reconciliation of GAAP to
non-GAAP financial information for the three
months ended March 31, 2009 and 2008:
|
| | | | | | |
| | Reported GAAP Amounts | | Share-Based Compensation Adjustment | | Non-GAAP Excluding Share-Based Compensation |
| | | | | | |
| Three Months Ended March 31, 2009 | | | | | | |
|
Research and development
| |
$
|
19,089
| | |
$
|
(2,238
|
)
| |
$
|
16,851
|
|
Selling, general and administrative
| | |
36,652
| | | |
(5,688
|
)
| | |
30,964
|
|
Operating expense
| | |
55,741
| | | |
(7,926
|
)
| | |
47,815
|
|
Net income
| | |
14,506
| | | |
7,926
| | | |
22,432
|
| | | | | | |
|
Net income per share
| | | | | | |
|
basic
| |
$
|
0.18
| | |
$
|
0.10
| | |
$
|
0.27
|
|
diluted
| |
$
|
0.16
| | |
$
|
0.09
| | |
$
|
0.25
|
| | | | | | |
|
Shares used in computing earnings per share
| | | | | | |
|
basic
| | |
81,698
| | | | | |
81,698
|
|
diluted
| | |
90,645
| | | | | |
91,910
|
| | | | | | |
| Three Months Ended March 31, 2008 | | | | | | |
|
Research and development
| |
$
|
15,609
| | |
$
|
(1,625
|
)
| |
$
|
13,984
|
|
Selling, general and administrative
| | |
29,781
| | | |
(4,260
|
)
| | |
25,521
|
|
Operating expenses
| | |
45,390
| | | |
(5,885
|
)
| | |
39,505
|
|
Net income (loss)
| | |
(4,249
|
)
| | |
5,885
| | | |
1,636
|
| | | | | | |
Basic and diluted net income (loss) per
share
| |
$
|
(0.06
|
)
| |
$
|
0.08
| | |
$
|
0.02
|
| | | | | | |
Shares used in computing basic and diluted
earnings per share
| | |
75,028
| | | | | |
78,162
|
SOURCE: Alexion Pharmaceuticals, Inc.
Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Sr. Director, Corporate Communications
or
Makovsky & Company (Media)
Kristie Kuhl, 212-508-9642
or
Rx Communications (Investors)
Rhonda Chiger, 917-322-2569
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