Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced financial results for the three months ended March 31, 2011. Alexion Pharmaceuticals, Inc. ("Alexion" or, the "Company") reported net product sales of Soliris® (eculizumab) of $166.1 million, reflecting steady additions of new patients, compared to $117.6 million for the same period in 2010.
“As we look ahead in 2011, we expect continued growth in our PNH operations and notable progress toward serving patients with other severe and ultra-rare disorders through the accelerated development of our expanded pipeline portfolio.”
Soliris, approved in the US (2007), European Union (2007) and Japan (2010), is the only drug specifically indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disease.
Historically, Alexion's non-GAAP operating results have been equal to GAAP operating results less both the impact of share-based compensation and taxes that are not payable in cash (non-cash taxes). With the completion of two acquisitions in the quarter, Alexion's non-GAAP operating results will now also exclude amortization of acquired intangible assets and costs associated with acquisitions. The following summary table is provided for investors' convenience:
First Quarter Non-GAAP Financial Results:
The Company reported non-GAAP net income of $56.3 million, or $0.59 per share, for the first quarter of 2011, compared to non-GAAP net income of $34.6 million, or $0.37 per share, in the first quarter of 2010.
Alexion's non-GAAP operating expenses for Q1 2011 were $85.9 million, compared to $65.2 million for Q1 2010. Non-GAAP research and development (R&D) expenses for Q1 2011 were $28.1 million, compared to $20.3 million for Q1 2010. The increase in R&D expenses primarily reflected the expansion of the Company's clinical trial programs. Non-GAAP selling, general and administrative (SG&A) expenses for Q1 2011 were $57.8 million, compared to $44.9 million for Q1 2010. The increase in non-GAAP SG&A expenses primarily reflected costs associated with the expansion of the Company's commercial operations in new geographies.
First Quarter GAAP Financial Results:
Alexion reported GAAP net income of $26.8 million, or $0.28 per share, for Q1 2011, including a negative after-tax impact of $6.9 million, or $0.07 per share, from costs related to the Taligen Therapeutics and Orphatec Pharmaceuticals acquisitions during the quarter, compared to Q1 2010 GAAP net income of $20.9 million, or $0.23 per share.
On a GAAP basis, operating expenses for Q1 2011 were $106.7 million, including $10.0 million of acquisition-related costs, compared to $73.0 million for Q1 2010. GAAP R&D expenses for Q1 2011 were $30.8 million, compared to $22.4 million for Q1 2010. GAAP SG&A expenses were $65.9 million for Q1 2011, compared to $50.6 million for Q1 2010.
As of March 31, 2011, the Company had $348.8 million in cash, cash equivalents and marketable securities, compared to $361.6 million at the end of 2010. The amount outstanding at the end of the quarter reflected outflows of approximately $114 million associated with the Taligen Therapeutics and Orphatec Pharmaceuticals acquisitions and inflows of $60 million in short-term borrowing during the first quarter.
"In the early months of 2011, we achieved steady growth in serving patients with PNH in our core territories, and started laying the initial groundwork for expanding into new major countries. At the same time, we have reached a key milestone in our aHUS program with our US and EU regulatory submissions," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "As we look ahead in 2011, we expect continued growth in our PNH operations and notable progress toward serving patients with other severe and ultra-rare disorders through the accelerated development of our expanded pipeline portfolio."
Research and Development Programs:
In early April, the Company announced that it has submitted marketing applications to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for Soliris as a treatment for patients with atypical Hemolytic Uremic Syndrome (aHUS). Both the US and EU submissions include the positive data from the two 26-week Phase 2 studies of Soliris as a treatment for adult and adolescent patients with aHUS.
Transplant: Acute Humoral Kidney Rejection (AHR)
Eculizumab is being investigated as a treatment for patients undergoing kidney transplant who are at elevated risk of antibody mediated rejection, also known as acute humoral rejection (AHR). Alexion today announced that it has recently concluded successful discussions with regulators regarding the clinical protocols for two global, company-sponsored controlled clinical trials evaluating eculizumab to prevent AHR in patients undergoing kidney transplant in living- or deceased-donor settings. The Company is preparing to initiate these studies later this year. Alexion continues to support investigator-initiated studies in elevated-risk kidney transplantation in the US and Australia.
New Product Development
Alexion has established a Translational Medicine Center of Excellence in Cambridge, Massachusetts, to more rapidly move early-stage drug candidates into clinical trials. Beyond eculizumab, the Company is initially focused on four unique and innovative drug candidates. Alexion has accelerated the clinical development of TT30, a specific inhibitor of the alternative complement pathway with a mechanism of action distinct from Soliris, and expects to initiate clinical development of TT30 in 2011. The Company is also focused on accelerating the development of its cPMP replacement therapy for patients with molybdenum cofactor deficiency (MoCD) Type A. In addition, a novel anti-inflammatory antibody is expected to enter clinical trials in a rare and life-threatening disorder in the second half of this year. Finally, the Company expects to initiate a clinical trial of samalizumab in patients with a rare, solid tumor later this year.
2011 Financial Guidance:
Earlier this month, Alexion updated its 2011 revenue guidance, from the previously announced range of $715 to $735 million, now to the higher range of $720 to $740 million. The upward revision in revenue guidance takes into account continued global growth of Soliris for PNH, and the potential for an earlier than previously expected launch of Soliris for aHUS in the US. The earlier US launch could occur if the regulatory submission is granted priority review by the FDA, and if a positive decision is then received, making a launch in the US possible late in the fourth quarter of 2011.
Other items of previously announced 2011 guidance are being reiterated at this time.
Alexion Pharmaceuticals, Inc.