Alexion Reports First Quarter 2013 Results

  Alexion Reports First Quarter 2013 Results

  Soliris^® (eculizumab) Net Product Sales Increased 38 Percent vs. Year-Ago
                          Quarter to $338.9 Million

           Continued Steady Growth in PNH; aHUS Launch Progressing

            Guidance Revised Upward for Revenues and Non-GAAP EPS

         Deceased-Donor Kidney Transplant Trial Enrollment Completed

      Hypophosphatasia Infant Natural History Study Enrollment Completed

           Single Myasthenia Gravis Registration Trial Now Planned

    Retrospective cPMP Clinical Study in MoCD Commenced; First Study With
                            Synthetic cPMP Planned

First Quarter 2013 Financial Highlights:

  *Q1 2013 net product sales increased 38 percent to $338.9 million, compared
    to $244.7 million in Q1 2012.

  *Q1 2013 GAAP net income increased 81 percent to $82.2 million, or $0.41
    per share, compared to Q1 2012 GAAP net income of $45.4 million, or $0.23
    per share.
  *Q1 2013 non-GAAP net income increased 49 percent to $131.3 million, or
    $0.65 per share, compared to Q1 2012 non-GAAP net income of $88.1 million,
    or $0.45 per share.

Business Wire

CHESHIRE, Conn. -- April 25, 2013

Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial results
and a development pipeline update for the three months ended March 31, 2013.
The Company reported net product sales of Soliris^® (eculizumab) of $338.9
million, an increase of 38 percent from the same period in 2012. Revenue
performance for the quarter reflects steady additions of new patients with
paroxysmal nocturnal hemoglobinuria (PNH) globally, and an increasing number
of new patients with atypical Hemolytic Uremic Syndrome (aHUS) commencing
Soliris treatment in the US and Western Europe.

“The first quarter was particularly noteworthy for the significant progress
across our lead development programs. This included completing enrollment in
the deceased-donor kidney transplant trial and the hypophosphatasia infant
natural history study, initiating plans for a single myasthenia gravis
registration trial, and accelerating our cPMP clinical programs,” said Leonard
Bell, M.D., Chief Executive Officer of Alexion. “During this past quarter we
continued to serve more patients with PNH around the world, as well as a
growing number of aHUS patients in the US, with initial aHUS patients
commencing treatment in countries of Western Europe. Further, in line with our
longer term growth objectives, we have also announced earlier today that we
are broadening and strengthening our executive leadership team.”

First Quarter 2013 Financial Results:

Alexion's non-GAAP operating results are GAAP operating results adjusted for
the impact of certain items described below. A full reconciliation of GAAP
results to non-GAAP results is included later in this press release.

First Quarter 2013 Non-GAAP Financial Results:

The Company reported non-GAAP net income of $131.3 million, or $0.65 per
share, in the first quarter of 2013, compared to non-GAAP net income of $88.1
million, or $0.45 per share, in the first quarter of 2012.

Alexion's non-GAAP operating expenses for Q1 2013 were $164.4 million,
compared to $119.9 million for Q1 2012. Non-GAAP research and development
(R&D) expenses for Q1 2013 were $66.4 million, compared to $42.1 million for
Q1 2012. Non-GAAP selling, general and administrative (SG&A) expenses for Q1
2013 were $97.9 million, compared to $77.9 million for Q1 2012.

First Quarter 2013 GAAP Financial Results:

Alexion reported GAAP net income of $82.2 million, or $0.41 per share, in the
first quarter of 2013, compared to GAAP net income of $45.4 million, or $0.23
per share, in the first quarter of 2012.

On a GAAP basis, operating expenses for Q1 2013 were $186.7 million, compared
to $146.4 million for Q1 2012. GAAP R&D expenses for Q1 2013 were $74.5
million, compared to $45.4 million for Q1 2012. GAAP SG&A expenses were $108.8
million for Q1 2013, compared to $87.2 million for Q1 2012.

Balance Sheet:

As of March 31, 2013, the Company had $1.02 billion in cash and cash
equivalents compared to $989.5 million at December 31, 2012.

Research and Development Progress:

Alexion currently has development programs underway with its five highly
innovative therapeutic candidates: eculizumab (Soliris) and four additional
novel therapeutic candidates beyond eculizumab that have the potential to
become first-in-class therapies for patients with other severe and ultra-rare
disorders.

Ultra-Rare Disease Programs With Eculizumab

  *Neurology: NMO - Alexion is preparing to commence what it expects to be a
    single Company-sponsored, multi-national, placebo-controlled, registration
    trial in relapsing neuromyelitis optica (NMO).
  *Neurology: MG – Alexion is also preparing to commence what it expects to
    be a single Company-sponsored, multi-national, placebo-controlled,
    registration trial in severe refractory myasthenia gravis (MG).
  *Nephrology: Kidney Transplant – Enrollment has now been completed in the
    Company-sponsored, multi-national deceased-donor kidney transplant trial
    in patients at elevated risk of antibody mediated rejection (AMR).
    Enrollment in the Company-sponsored, multi-national living-donor kidney
    transplant trial in patients at elevated risk of AMR is on-going. Alexion
    is also expanding its kidney transplant program to include a delayed-graft
    function (DGF) clinical trial.
  *Nephrology: STEC-HUS –  The Company is obtaining and analyzing additional
    longer-term control clinical outcome data from an epidemiologic study in
    approximately 400 STEC-HUS patients who received only best supportive care
    during the 2011 German epidemic.

Ultra-Rare Disease Programs with Highly Innovative Therapeutics Beyond
Eculizumab

  *Asfotase Alfa: Alexion completed enrollment in a retrospective natural
    history study in infants with hypophosphatasia (HPP), an ultra-rare,
    inherited and life-threatening metabolic disease.
  *cPMP Replacement Therapy: Alexion is developing a cPMP replacement therapy
    for the treatment of patients with Molybdenum Cofactor Deficiency Type A
    (MoCD), a severe, ultra-rare and genetic metabolic disorder that is fatal
    in newborns. Alexion has commenced a retrospective cPMP study in MoCD
    patients and a study with the Company’s synthetic cPMP is planned.
  *ALXN1102/1103: Enrollment continues in a Phase I study to characterize the
    mechanism of action and develop initial safety data for ALXN1102 and
    ALXN1103, intravenous and subcutaneous versions, respectively, of one of
    Alexion’s novel complement inhibitors.
  *ALXN1007: Alexion has completed dosing in a single-dose Phase I study of
    ALXN1007, a novel anti-inflammatory antibody, to evaluate the safety,
    tolerability, pharmacokinetics and pharmacodynamics of this therapeutic
    candidate in healthy volunteers. The Company expects to meet with
    regulators to discuss a multi-dose Phase I study.

2013 Financial Guidance:

Alexion today announced that it is raising its 2013 revenue guidance from the
previous range of $1.490 to $1.505 billion, now to the higher range of $1.505
to $1.520 billion. The upward revision reflects continued global growth of
Soliris in PNH and growth from the ongoing launch of Soliris in aHUS. Guidance
for 2013 non-GAAP earnings per share is also being raised, from the previous
range of $2.82 to $2.92, now to the higher range of $2.87 to $2.97 per share.
Alexion is reiterating all other items of the 2013 financial guidance provided
in the Company’s press release of February 14, 2013.

Conference Call/Web Cast Information:

Alexion will host a conference call/audio web cast to discuss matters
mentioned in this release. The call is scheduled for today, April 25, at 10:00
a.m., Eastern Time. To participate in this call, dial 888-312-3051 (USA) or
719-325-2168 (International), passcode 7274940, 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 PM, Eastern Time. The replay number is
888-203-1112 (USA) or 719-457-0820 (International), passcode 7274940. The
audio webcast can be accessed at www.alexionpharma.com.

About Soliris:

Soliris is a first-in-class terminal complement inhibitor developed from the
laboratory through regulatory approval and commercialization by Alexion.
Soliris is approved in the US, European Union, Japan and other countries as
the first and only treatment for patients with paroxysmal nocturnal
hemoglobinuria (PNH), a debilitating, ultra-rare and life-threatening blood
disorder, characterized by complement-mediated hemolysis (destruction of red
blood cells). Soliris is indicated to reduce hemolysis. Soliris is also
approved in the US and the European Union as the first and only treatment for
patients with atypical hemolytic uremic syndrome (aHUS), a debilitating,
ultra-rare and life-threatening genetic disorder characterized by
complement-mediated thrombotic microangiopathy, or TMA (blood clots in small
vessels). Soliris is indicated to inhibit complement-mediated TMA. The
effectiveness of Soliris in aHUS is based on the effects on TMA and renal
function. Prospective clinical trials in additional patients are ongoing to
confirm the benefit of Soliris in patients with aHUS. Soliris is not indicated
for the treatment of patients with Shiga toxin E. coli related hemolytic
uremic syndrome (STEC-HUS). For the breakthrough innovation in complement
inhibition, Alexion and Soliris have received the pharmaceutical industry's
highest honors: the 2008 Prix Galien USA Award for Best Biotechnology Product
with broad implications for future biomedical research and the 2009 Prix
Galien France Award in the category of Drugs for Rare Diseases. More
information including the full prescribing information on Soliris is available
at www.soliris.net.

About Alexion:

Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on
serving patients with severe and ultra-rare disorders through the innovation,
development and commercialization of life-transforming therapeutic products.
Alexion is the global leader in complement inhibition and has developed and
markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS,
two debilitating, ultra-rare and life-threatening disorders caused by chronic
uncontrolled complement activation. Soliris is currently approved in more than
40 countries for the treatment of PNH, and in the United States and European
Union for the treatment of aHUS. Alexion is evaluating other potential
indications for Soliris and is developing four other highly innovative
biotechnology product candidates, which are being investigated across nine
severe and ultra-rare disorders beyond PNH and aHUS. This press release and
further information about Alexion Pharmaceuticals, Inc. can be found at:
www.alexionpharma.com.

[ALXN-E]

This news release contains forward-looking statements, including statements
related to guidance regarding anticipated financial results for 2013,
assessment of the Company's financial position and commercialization efforts,
medical benefits and commercial potential for Soliris for PNH and aHUS and
other potential indications, expansion of clinical and commercial operations
to additional countries, medical and commercial potential of Alexion's
complement-inhibition technology and other technologies, plans for clinical
programs for each of our product candidates and progress in developing
commercial infrastructure. 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 for PNH and aHUS
and other potential indications, delays in arranging satisfactory
manufacturing capabilities and establishing commercial infrastructure, failure
to satisfactorily address the issues raised by the FDA in the Warning Letter
recently disclosed by Alexion, the possibility that results of clinical trials
are not predictive of safety and efficacy results of Soliris in broader
patient populations in the disease studied or other diseases, the risk that
acquisitions will not result in short-term or long-term benefits, the
possibility that current results of commercialization are not predictive of
future rates of adoption of Soliris in PNH, aHUS or other diseases, the risk
that third parties will not agree to license any necessary intellectual
property to Alexion on reasonable terms or at all, the risk that third party
payors (including governmental agencies) will not reimburse or continue to
reimburse for the use of Soliris at acceptable rates or at all, the risk that
estimates regarding the number of patients with PNH, aHUS or other disorders
are inaccurate, and a variety of other risks set forth from time to time in
Alexion's filings with the US 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, 2012 and in our other filings with the US
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.

In addition to financial information prepared in accordance with GAAP, this
news 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: the impact of share-based compensation
expense, acquisition-related costs, taxes related to acquisition structuring,
intangible asset impairments, upfront and milestone payments related to
licensing and collaboration agreements, and non-cash taxes. 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 Reconciliation
of GAAP to Non-GAAP Net Income 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, 2013 and 2012.


ALEXION PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
                                                         
                                                     Three months ended
                                                     March 31
                                                      2013        2012    
                                                                   
  Net product sales                                  $ 338,941     $ 244,733
                                                                   
  Cost of sales                                        35,269        28,268
                                                                   
  Research and development                             74,536        45,408
  Selling, general and administrative                  108,826       87,242
  Acquisition-related costs                            3,234         13,673
  Amortization of purchased intangible                 104           104
  assets
                                                                  
  Total operating expenses                            186,700     146,427 
                                                                   
  Operating income                                     116,972       70,038
                                                                   
  Interest and other expense                          (231    )    (2,229  )
                                                                   
  Income before income taxes                           116,741       67,809
                                                                   
  Income tax provision                                 34,524        22,396
                                                                  
  Net income                                         $ 82,217     $ 45,413  
                                                                   
  Earnings per common share
  Basic                                              $ 0.42       $ 0.24    
  Diluted                                            $ 0.41       $ 0.23    
                                                                   
  Shares used in computing earnings
  per common share
  Basic                                               194,771     185,682 
  Diluted                                             199,057     194,560 
                                                                             

                                                                 
ALEXION PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME
(in thousands, except per share amounts)
(unaudited)
                                                         Three months ended
                                                         March 31
                                                         2013        2012
                                                                     
    GAAP net income                                      $ 82,217    $ 45,413
                                                                     
    Share-based compensation expense (1)                   16,855      13,318
    Acquisition-related costs (2)                          3,234       13,673
    Amortization of purchased intangible assets            104         104
    Upfront and milestone payments related to license
    and
    collaboration agreements (3)                           3,000       -
    Non-cash taxes (4)                                     25,904      15,553
                                                                    
    Non-GAAP net income                                  $ 131,314   $ 88,061
                                                                     
    Shares used in computing diluted earnings per share    199,057     194,560
    (GAAP)
    Shares used in computing diluted earnings per share    202,225     195,895
    (non-GAAP)
                                                                     
    GAAP earnings per share - diluted                    $ 0.41      $ 0.23
    Non-GAAP earnings per share - diluted                $ 0.65      $ 0.45
                                                                       

    
      The following table summarizes the share-based compensation expense for
(1)   each expense category in our condensed consolidated statements of
      operations:

                                                             
                                                           Three months ended
                                                           March 31
                                                           2013       2012
      Share-based compensation expense:
      Cost of sales                                        $ 875      $ 603
      Research and development                               5,090      3,349
      Selling, general and administrative                   10,890    9,366
                                                           $ 16,855   $ 13,318
                                                                      
(2)   The following table summarizes
      acquisition-related costs:
                                                                      
                                                           Three months ended
                                                           March 31
                                                           2013       2012
      Acquisition-related costs:
      Separately-identifiable employee costs               $ 248      $ 2,296
      Professional fees                                      775        8,469
      Changes in fair value of contingent                   2,211     2,908
      consideration
                                                           $ 3,234    $ 13,673
                                                                        

      In January 2013, the Company entered into a license agreement providing
      Alexion with an exclusive research license and an option for an
(3)  exclusive commercial license for specific targets and products to be
      developed from a platform technology. Under the terms of the agreement,
      the Company recorded research and development expense for an upfront
      payment of $3,000.
      
      Non-cash taxes represents the adjustment from GAAP tax expense to the
(4)   amount of taxes that are payable in cash. The adjustment includes tax
      amounts that are not currently payable in cash due to the continued
      utilization of our US net operating losses and credits.

                                                        
ALEXION PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited)
                                                                  
                                                   March 31   December 31,
                                                   2013         2012
  Cash and cash equivalents                        $  1,022,960   $  989,501
  Trade accounts receivable, net                      323,907        295,598
  Inventories, net                                    101,856        94,521
  Deferred tax assets, current                        19,995         26,086
  Other current assets                                81,323         89,894
  Property, plant and equipment, net                  164,966        165,629
  Deferred tax assets, noncurrent                     11,980         13,954
  Intangible assets, net                              644,965        646,678
  Goodwill                                            254,073        253,645
  Other noncurrent assets                            59,856        38,054
  Total assets                                     $  2,685,881   $  2,613,560
                                                                  
  Accounts payable and accrued                     $  212,545     $  271,275
  expenses
  Current portion of long-term debt                   48,000         48,000
  Other current liabilities                           35,202         40,814
  Long-term debt                                      101,000        101,000
  Contingent consideration                            141,181        139,002
  Other noncurrent liabilities                       57,900        42,619
  Total liabilities                                  595,828       642,710
                                                                  
  Total stockholders' equity                         2,090,053     1,970,850
  Total liabilities and                            $  2,685,881   $  2,613,560
  stockholders' equity

Contact:

Alexion Pharmaceuticals, Inc.
Irving Adler, 203-271-8210
Executive Director, Corporate Communications
or
Rx Communications (Investors)
Rhonda Chiger, 917-322-2569
 
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