Alexion Reports Third Quarter 2007 Results
Soliris(R) Growth Driven by Increase in Treated Patients and Prescribing Physicians Third Quarter 2007 Highlights:
* Soliris(R) (eculizumab) net product sales totaled $21.8 million in Q3 2007, compared to net product sales of $9.8 million in Q2 2007.
* Net loss totaled $20.1 million, or $0.55 per common share, compared to a net loss of $27.2 million, or $0.75 per common share in Q2 2007.
* Non-GAAP net loss totaled $14.0 million, or $0.38 per common share, compared to a non-GAAP net loss of $21.8 million, or $0.61 per common share in Q2 2007.
CHESHIRE, Conn., Oct 25, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced financial results for the quarter ended September 30, 2007.
Third Quarter 2007 Financial Results:
For the three months ended September 30, 2007, Alexion Pharmaceuticals, Inc. (the "Company" or "Alexion") reported revenues of $22.1 million compared to revenues of $0.3 million for the same period last year. Revenues for the third quarter included Soliris(R) net product sales of $21.8 million, compared with $9.8 million in the second quarter of 2007. U.S. sales of Soliris commenced in Q2 2007.
The Company incurred a net loss for the third quarter of 2007 of $20.1 million, or $0.55 per common share, compared to a net loss of $31.9 million, or $1.02 per common share, for the same period during 2006. Excluding share- based compensation, the Company incurred a non-GAAP net loss for the third quarter of 2007 of $14.0 million, or $0.38 per common share, versus a non-GAAP net loss of $27.3 million, or $0.87 per common share, for the same period during 2006. The Q3 2007 non-GAAP net loss of $14.0 million, or $0.38 per common share, was reduced from a non-GAAP net loss of $21.8 million, or $0.61 per common share in Q2 2007.
Operating expenses for the third quarter of 2007 were $41.9 million, compared to $33.3 million for the same period last year. Research and development expenses for the third quarter were $16.9 million, compared to $21.2 million for the same period last year. The decrease in third quarter 2007 research and development expenses compared to the same period in 2006 is primarily related to costs of the Biologic License Application (BLA) incurred in the third quarter of 2006 and the termination of the Company's pexelizumab programs in late 2006, offset by increased costs of Alexion's EXPLORE clinical trial. Selling, general and administrative expenses were $24.9 million for the third quarter of 2007, compared to $12.1 million for the same period last year. The increase in selling, general and administrative expenses for the third quarter of 2007 was primarily related to the development of commercial operations and other infrastructure to support the launch of Soliris in the United States and Europe. Operating expenses for the third quarter of 2007 include $6.1 million of share-based compensation expense, compared to $4.6 million in the same period last year.
The Company posted investment income of $1.8 million for third quarter of 2007, the same amount as in the third quarter of 2006. Interest expense in the third quarter was $0.6 million, compared to $0.7 million for the same period last year.
The Company has commenced engineering runs in its Rhode Island manufacturing facility following completion of construction. During the third quarter of 2007, the Company capitalized all costs associated with bringing the facility to its intended use, including costs of engineering runs and interest, for a total of $15.2 million. Total capitalized costs to date for the Rhode Island facility, including construction, renovations, upgrades, engineering runs and interest is $79.2 million.
Soliris product sold in the third quarter was previously accounted for as an R&D expense prior to submission of the BLA and was not included in the cost of sales during the third quarter. Cost of sales for the third quarter included actual and estimated royalty costs related to the sale of Soliris, as well as other manufacturing costs.
As of September 30, 2007, the Company had $125.7 million in cash, cash equivalents, and marketable securities, compared to $250.1 million at December 31, 2006. Included in the Company's cash balance at September 30, 2007 was $13.8 million of restricted cash designated for costs associated with the manufacturing facility in Rhode Island. The decrease in cash, cash equivalents, and marketable securities is attributable to costs of the manufacturing facility, inventory purchases, as well as the continued development of commercial operations, offset by proceeds of $18.0 million related to the July 2007 amendment of the Company's existing mortgage loan.
Soliris Commercial Update
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The number of patients on Soliris therapy increased significantly during the third quarter as Alexion continued to execute its U.S. launch plan and pre-launch efforts in Europe. The number of treating physicians also increased significantly.
"We were able to bring the benefits of Soliris therapy to a substantially greater number of patients in the third quarter," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "Patients, physicians and payors are responding consistently and favorably to Soliris as a treatment that targets hemolysis, the underlying cause of PNH. We remain steadfast in our goal of making Soliris available to every PNH patient who can benefit from it."
Alexion continues pre-commercial sales of Soliris to an increasing number of patients on a named-patient basis in Europe, while engaging in the reimbursement, price approval and funding processes that are separately required by each European country. Alexion expects to achieve commercial status by the end of this year in Germany and the United Kingdom.
"Europe represents an important opportunity for Alexion," said David Keiser, President and Chief Operating Officer of Alexion. "We have established relationships with an expanding group of treating physicians in each country and have attracted to our organizations highly experienced professionals with the country-specific commercial expertise we require. Our infrastructure is in place for the planned launch of Soliris in the first two European countries by the end of the year."
Clinical
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In August, a clinical study published online in Blood, the journal of the American Society of Hematology (ASH), reported that Soliris achieved a 92 percent reduction in the number of life-threatening blood clots in clinical trials with PNH patients. This publication further points out the high risk of thrombosis in patients suffering from PNH.
Financial Guidance:
The Company's earlier guidance of GAAP-based total operating expenses for 2007 in the range of $160 to $180 million has been narrowed to $160 to $170 million. Excluding the expense of employee stock options and other share-based compensation expense, the previously projected non-GAAP total operating expenses for 2007 in the range of $140 to $160 million has been narrowed to $140 to $150 million.
Conference Call/Web Cast Information
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Alexion will host a conference call/webcast to discuss matters mentioned in this release. The call is scheduled for today, October 25, 2007, at 10:00 a.m., Eastern Time. To participate in this call, dial 719-325-4817, confirmation code 3517204, 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 3517204. The audio webcast can be accessed at www.alexionpharm.com. |
