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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported) October 8, 1998
ALEXION PHARMACEUTICALS, INC.
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(Exact Name of Registrant as Specified in its Charter)
DELAWARE 0-27756 13-3648318
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(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
25 SCIENCE PARK, NEW HAVEN, CT 06511
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (203) 776-1790
NOT APPLICABLE
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(Former Name or Former Address, if Changed Since Last Report)
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ITEM 5. OTHER EVENTS
On October 8, 1998, Alexion Pharmaceuticals, Inc. issued the press release
filed herewith as Exhibit 99.
ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.
(c) EXHIBITS.
99 Press Release dated October 8, 1998.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
ALEXION PHARMACEUTICALS, INC.
Date: October 8, 1998 By: /s/ LEONARD BELL, M.D.
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Name: Leonard Bell, M.D.
Title: President, Chief Executive Officer,
Secretary and Treasurer
EXHIBIT 99
IMMEDIATE RELEASE CONTACT: Leonard Bell, M.D. Rhonda Chiger (investors)
- ----------------- President and CEO Susan Farley (media)
Alexion Pharmaceuticals Dewe Rogerson Inc.
203/776-1790 212/688-6840
ALEXION PHARMACEUTICALS REPORTS
FOURTH QUARTER AND YEAR END RESULTS
New Haven, CT, October 8, 1998 -- Alexion Pharmaceuticals, Inc. (Nasdaq:
ALXN) today announced the Company's financial results for its fourth quarter and
fiscal year ended July 31, 1998.
During the fourth quarter, Alexion received contract research revenues and
licensing fees amounting to $490,000 compared to $941,000 in revenues received
in the same period ended July 31, 1997. The Company's research and development
expenses for the three month period increased to $4.04 million from $3.17
million for the same period last year, and net loss for the fourth quarter was
$3.71 million or $0.33 per share compared to a net loss of $2.73 million or
$0.35 per share reported in the fourth quarter of last year.
For the twelve months ended July 31, 1998, revenues were $5.04 million
compared to $3.81 million for the same period last year. The increase was due
primarly to revenues received from U.S. Surgical Corporation in return for
additional licensing and other property rights associated with the companies'
collaboration in the development of xenograft products. The Company's research
and development expenses for fiscal year 1998 were $12.32 million compared to
$9.08 million for the twelve months ended July 31, 1997. Increased research and
development expenses were attributable principally to further clinical
development and manufacturing of the Company's lead C5 Complement Inhibitors,
5G1.1-SC and 5G1.1, and expanded preclincal research and process development
efforts in support of Alexion's other product candidates in the Company's C5
Complement Inhibitor, Apogen, and xenograft product development programs.
The Company's net loss for the fiscal year ended July 31, 1998 increased to
$7.87 million or $0.87 per share, from a net loss of $7.25 million or $0.97 per
share for the prior year.
At July 31, 1998, the Company's cash, cash equivalents and marketable
securities amounted to $37.49 million as compared to $22.75 million on July 31,
1997. The increase in the Company's cash position compared to last year, is due
primarily to the completion of two private placements of common stock in
September 1997 and March 1998 totaling $18.8 million and receipt of an
additional $6.5 million from U.S. Surgical Corporation in connection with the
modification of a pre-existing agreement focused on the Companies' joint
development of Alexion's xenotransplantation program.
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"The financial results of both the fourth quarter and our full 1998 fiscal
year are in line with our expectations," said David Keiser, Executive Vice
President and Chief Operating Officer of Alexion. "Progress, particularly with
the clinical development of the Company's C5 Inhibitors in cardiopulmonary
bypass patients and in rheumatoid arthritis and lupus patients, has necessitated
higher investments in development and manufacturing. We are pleased that despite
this greater commitment of the Company's resources, our net loss for the year
could be maintained at approximately last year's levels and that the Company's
cash position could be significantly enhanced to support continued progress in
clinical development, clinical manufacturing and preclinical research for our C5
Inhibitor, Apogen and xenograft product development programs."
During the past year, Alexion has substantially advanced the clinical
development of its two lead C5 Inhibitor anti-inflammatory drug candidates. For
its lead C5 Complement Inhibitor, 5G1.1-SC, Alexion has completed Phase I/II and
Phase IIa trials in its initial acute coronary syndrome indication,
cardiopulmonary bypass (CPB). In April, results from these clinical studies were
released indicating that, in patients undergoing CPB, 5G1.1-SC, compared to
placebo-treated patients, significantly reduced important clinical morbidities,
including cardiac damage by approximately 40%, new cognitive deficits by
approximately 80% and postoperative blood loss by approximately 400 ml (about 1
pint). This past summer, Alexion also commenced dosing with its second C5
Complement Inhibitor, 5G1.1, in Phase I/II trials in both rheumatoid arthritis
and lupus patients and has laid the groundwork for commencing clinical studies
for its Apogen product, MP4, in multiple sclerosis patients.
Alexion also announced today that it had been awarded a new $2 million
grant from the Advanced Technology Program to support an ongoing program
targeting the development of genetically engineered tissues to treat patients
with severe, debilitating spinal cord injuries.
Alexion has received the last scheduled $100,000 payment of the total $1.5
million in license and research payments due from Genetic Therapy, Inc. (GTI)
with respect to GTI's development of immune protected viral gene therapy
products. In view of Alexion's increased focus on the advanced clinical
development of its anti-inflammatory drug candidates and GTI's recently
announced restructuring and reorganization, the parties have agreed to
discontinue the collaborative gene therapy program.
Alexion Pharmaceuticals, Inc. was founded in 1992 and is engaged in the
development of selective immunotherapeutic drugs that generally are designed to
inhibit the disease-causing segments of the immune system while preserving the
disease-preventing aspects of the immune system. The Company is developing three
technology platforms: C5 Complement Inhibitors and Apogen T-Cell Therapeutics
which together target severe cardiovascular and autoimmune disorders; and
xenografts for organ transplants.
THIS NEWS RELEASE CONTAINS FORWARD LOOKING STATEMENTS. SUCH STATEMENTS ARE
SUBJECT TO CERTAIN FACTORS WHICH MAY CAUSE ALEXION'S PLANS TO DIFFER OR RESULTS
TO VARY FROM THOSE EXPECTED INCLUDING UNEXPECTED PRECLINICAL OR CLINICAL
RESULTS, THE NEED FOR ADDITIONAL RESEARCH AND TESTING, DELAYS IN MANUFACTURING,
ACCESS TO CAPITAL AND FUNDING, DELAYS IN DEVELOPMENT OF COMMERCIAL RELATIONSHIPS
AND A VARIETY OF 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 YEAR ENDED JULY 31,
1997. ALEXION UNDERTAKES NO OBLIGATION TO PUBLICLY RELEASE RESULTS OF ANY OF
THESE FORWARD LOOKING STATEMENTS WHICH MAY BE MADE TO REFLECT EVENTS OR
CIRCUMSTANCES AFTER THE DATE HEREOF OR TO REFLECT THE OCCURRENCE OF
UNANTICIPATED EVENTS.
-more-
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ALEXION PHARMACEUTICALS, INC.
SELECTED FINANCIAL DATA
STATEMENTS OF OPERATIONS
(dollars in thousands)
Year ended July 31, Three months ended July 31,
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1998 1997 1998 1997
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(audited) (audited) (audited) (audited)
CONTRACT RESEARCH REVENUES ................ $ 5,037 $ 3,811 $ 490 $ 941
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OPERATING EXPENSES:
Research and Development ......... 12,323 9,079 4,040 3,171
General and Administrative ....... 2,666 2,827 717 719
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Total Operating Expenses ......... 14,989 11,906 4,757 3,890
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OPERATING LOSS ............................ (9,952) (8,095) (4,267) (2,949)
OTHER INCOME, Net ......................... 2,087 843 553 217
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NET LOSS .................................. $ (7,865) $ (7,252) $ (3,715) $ (2,732)
Preferred Stock Dividends ........ (900)
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NET LOSS APPLICABLE TO
COMMON SHAREHOLDERS .................... $ (8,765) $ (7,252) $ (3,715) $ (2,732)
NET LOSS PER COMMON SHARE
(basic and diluted) ................... $ (0.87) $ (0.97) $ (0.33) $ (0.35)
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SHARES USED IN COMPUTING NET
LOSS PER COMMON SHARE .................. 10,056,339 7,450,762 11,225,104 7,762,873
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BALANCE SHEET DATA
(dollars in thousands)
July 31, 1998 July 31, 1997
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(audited) (audited)
Cash, cash equivalents
and marketable securities ................. $37,494 $22,749
Total Assets ................................. 42,085 24,260
Net Stockholders' Equity ..................... 39,190 21,846
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