>>CHARLESTOWN, Mass., March 14 /PRNewswire-FirstCall/ -- BioTransplant Incorporated (Nasdaq: BTRN - news) today reported financial results for the quarter and year ended December 31, 2001.
Revenues for the fourth quarter of 2001 increased to $478,000, up from $106,000, reported for the same quarter last year. The increase in revenues was primarily due to $263,000 in product sales of the Eligix(TM) HDM Cell Separation Systems, which were launched in Europe during the fourth quarter of 2001 by the Company's distribution partner, Gambro BCT. During the third quarter of 2001, prior to the launch of sales by Gambro, the Company reported $93,000 of product revenues from sales of its Eligix(TM) HDM Cell Separation Systems. In addition, $215,000 in license and milestone revenues was recognized in the fourth quarter from a total of $6.0 million in upfront license fees and milestone payments received in connection with the Company's exclusive distribution agreement with Gambro. The upfront fees and milestone payments under the Gambro distribution agreement will be recognized as revenue ratably over approximately seven years.
Revenues for the year ended December 31, 2001 decreased to $0.7 million from $4.6 million for the year ended December 31, 2000. This decrease was primarily due to the fact that during 2000 all revenues were derived from sponsored research payments under the former Novartis agreement. In late 2000, the Company formed Immerge BioTherapeutics, a joint venture with Novartis in xenotransplantation, which supersedes the prior collaboration. Revenues in 2001 represent sales of the Eligix(TM) HDM Cell Separation Systems of approximately $356,000, and approximately $334,000 in Gambro milestone payments and up-front license fees, which are being recognized ratably over the remaining life of the Company's distribution agreement.
``During 2001, BioTransplant progressed from being a research and development-stage company to a company that also is engaged in the commercialization of products, with initial revenues from product sales of the Eligix(TM) HDM Cell Separation Systems,'' commented Elliot Lebowitz, Ph.D., CEO of BioTransplant. ``In 2002, we look forward to further results from MedImmune's Phase II trials of our MEDI-507 monoclonal antibody product for the treatment of psoriasis, which MedImmune is developing as a stand-alone agent under the name Siplizumab. We continue making progress with clinical trials of our AlloMune System for Cancer and, through Immerge BioTherapeutics, continue to pursue further research in the area of xenotransplantation to address the human organ shortage.''
Research and development expenses for the three months ended December 31, 2001 decreased to $3.0 million, from $4.0 million for the three months ended December 31, 2000, and research and development expenses for the year ended December 31, 2001 decreased to $10.9 million from $15.0 million for the year ended December 31, 2000. The decrease in research and development expenses was due in part to $1.0 million and $7.8 million of reimbursements the Company received from Immerge for the quarter and year ended December 31, 2001, respectively, for the use of approximately 20 full-time research personnel, in accordance with the terms of the Company's contract research agreement with Immerge. The decrease was also due in part to decreased levels of external research support in 2001. The decrease in research and development expenses for the year ended December 31, 2001 was partially offset by approximately $2.5 million of expenses related to the consolidation of Eligix operations, which are included in operating expenses beginning May 15, 2001.
General and administrative expenses for the three months ended December 31, 2001 increased to $2.2 million from $0.7 million for the three months ended December 31, 2000, and general and administrative expenses for the year ended December 31, 2001 increased to $4.9 million from $2.5 million for the year ended December 31, 2000. The increase in general and administrative expenses was primarily due to increased expenses relating to the integration of Eligix, which was acquired by BioTransplant in May 2001.
For the quarter ended December 31, 2001, the Company reported a net loss of $8.0 million, or $0.40 per share, including $3.1 million in amortization and stock-based compensation related to the acquisition of Eligix, compared to a net loss of $4.3 million, or $0.36 per share, for the same period in 2000. Excluding these non-cash charges, the Company reported a pro forma net loss for the quarter ended December 31, 2001 of $4.9 million, or $0.25 per share.
For the year ended December 31, 2001, the Company reported a net loss of $42.6 million, or $2.60 per share, including $20.0 million of in-process research and development charges, $2.6 million in amortization of intangibles and $5.1 million in stock-based compensation related to the acquisition of Eligix compared to a net loss of $11.7 million, or $1.01 per share for 2000. Excluding these non-cash charges, the Company reported a pro forma net loss for the year ended December 31, 2001 of $15.0 million, or $0.91 per share.
The Company had cash, cash equivalents and short-term investments of $14.7 million as of December 31, 2001, as compared to $14.9 million as of December 31, 2000. The Company anticipates that its existing cash, cash equivalents and short-term investments and debt will be sufficient to fund its operating and capital requirements as currently planned into the first quarter of 2003. To continue operations beyond the first quarter of 2003, the Company will need to raise additional funds, and may seek to raise these funds through additional financings, including public or private equity offerings, collaborative arrangements with corporate partners or a combination of any of the foregoing.
On May 15, 2001, the Company completed its acquisition of Eligix, Inc. The Company accounted for the acquisition as a purchase. In accordance with the requirements of GAAP, the Company allocated the purchase price for the acquisition to the assets acquired, including intangible assets consisting of in-process research and development, acquired technology and goodwill. The allocations among the intangible assets were based upon an independent third-party valuation of the intangible assets acquired. Synergies, such as the value expected to be derived from the planned use of the Eligix(TM) HDM Cell Separation Systems technology as part of the Company's AlloMune Systems, were excluded from the valuation pursuant to applicable accounting standards and SEC guidelines. As a result of a preliminary valuation, performed in December 2000, the Company allocated $20.0 million to in-process research and development, or IPR&D, and $25.0 million to acquired technology. The excess of the purchase price over the fair value of identified intangible and tangible assets of $5.7 million was allocated to goodwill. During 2001, the intangible assets, including acquired technology and goodwill, were amortized over their estimated useful lives of seven years. The fair value of the IPR&D was recorded as an expense as of the acquisition date. In connection with the Company's year-end audit, the third-party valuation firm finalized its valuation as of May 15, 2001 based upon revised estimates of expected cash flows from the developed portion of the technology acquired from Eligix and other variables. As a result of the final valuation report, the Company reallocated $14.0 million from acquired technology to goodwill. As a result, the Company continued to allocate $20.0 million to IPR&D, and allocated $11.0 million to acquired technology and $19.7 million to goodwill. Finally, the Company performed a review of its intangible assets as of December 31, 2001 and determined that no impairment exists. The reallocation had no impact on the Company's statement of operations for the year ended December 31, 2001.
2001 Highlights
*MEDI-507
MEDI-507 is BioTransplant's humanized monoclonal antibody, which has been exclusively licensed to MedImmune, which is developing it as a stand-alone agent under the name Siplizumab. BioTransplant is entitled to receive royalties on any product sales for Siplizumab and future generations of stand-alone agents. MedImmune is currently conducting clinical trials of Siplizumab for the treatment of psoriasis.
During 2001, as reported by MedImmune, Siplizumab has demonstrated significant progress in the Clinic, including:
-- Phase II psoriasis program for Siplizumab has expanded to include
patients in Europe.
-- Clinical results for Siplizumab as psoriasis treatment were presented
at the International Psoriasis Symposium, showing it to be generally
safe and well-tolerated.
-- Phase II study with Siplizumab in psoriasis patients began.
-- Data from three initial clinical studies for Siplizumab were
presented at the European Society of Dermatological Research showing
Siplizumab to be generally well-tolerated and resulting in improved
PASI (Psoriasis Area and Severity Index) scores. Results were also
durable after completion of treatment.
-- Enrollment was completed for Phase II clinical trials for Siplizumab
in psoriasis patients.
*Eligix(TM) HDM Cell Separation System
The Company's Eligix(TM) HDM Cell Separation System technologies use monoclonal antibodies to remove unwanted cells from bone marrow, peripheral blood stem cell and donor leukocyte transplant procedures. These systems are being developed to have broad applications for treating certain blood cancers and solid tumor cancers, as well as autoimmune diseases and other conditions.
During 2001, BioTransplant made significant advances in developing and commercializing the Eligix(TM) HDM Cell Separation System, including:
-- Received CE Mark authorization for the BCell-SC and the CD8-DLI Cell
Separation Systems.
-- BioTransplant and Gambro signed an exclusive distribution agreement
for the Eligix product line and received a $4.0 million licensing
fee, which will be recognized as revenue over the seven-year term of
the distribution agreement.
-- BioTransplant's BCell-SC and CD8-DLI Cell Separation Systems were
launched by Gambro BCT in Europe in late 2001. Under the terms of
the Company's distribution agreement with Gambro, BioTransplant
received milestone payments from Gambro totaling $2 million, which
will be recognized as revenue over the seven-year term of the
distribution agreement.
*Corporate Highlights
Important corporate highlights for 2001 include:
-- Launched the operations of Immerge BioTherapeutics, the Company's
joint venture company with Novartis.
-- The Company's collaborative partner, Massachusetts General Hospital,
was awarded a key patent in xenotransplantation, US patent 6190861
entitled "Molecular Sequence of Swine Retrovirus and Methods of Use."
-- Completed the acquisition of Eligix. This stock-for-stock merger
added late-stage pipeline products, added near-term European revenue
and is also expected to add additional product candidates in earlier
phases of development, expanding BioTransplant's current product
pipeline.
-- Completed a private placement of approximately 3 million shares of
newly issued common stock, at a purchase price of $6.30 per share,
netting $17.9 million, to selected institutional and accredited
investors.
-- Announced with Massachusetts General Hospital clinical success with a
double transplant procedure in two patients with end-stage renal
disease and multiple myeloma. The procedure is expected to free the
patient from the need for whole body irradiation to treat cancer and
eliminate the need for life-long immunosuppressive drugs to prevent
donor graft rejection.
About BioTransplant
BioTransplant Incorporated, headquartered in Charlestown, Massachusetts, is developing a portfolio of products for application in a range of medical conditions, including treatment of cancer and autoimmune diseases, organ and tissue transplantation, for which current therapies are inadequate. Siplizumab (MEDI-507), a lead product we exclusively licensed to MedImmune, is in Phase II clinical trials for the treatment of psoriasis. In addition, the Company is developing the AlloMune System which is designed to treat a variety of hematologic malignancies, and its distribution partner Gambro BCT markets the Eligix family of cell separation products in Europe for use in bone marrow, stem cell and donor leukocyte transplants.
Conference Call
BioTransplant management will be holding a conference call at 10:00 a.m. Eastern time today to discuss these results. Investors may access the call at the company's website at biotransplant.com. This call will not be archived or available for replay.
This news release contains forward-looking statements about BioTransplant that involve risks and uncertainties, including statements about BioTransplant's expectations with respect to its ability to fund operations through the first quarter of 2003. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors. Important factors that could cause future results to differ materially from such forward-looking statements include, but are not limited to: BioTransplant's ability to secure the additional funding required for its operations and research and development programs; BioTransplant's and its third party collaborators' ability to successfully discover, develop and commercialize its products, obtain and maintain required regulatory approvals in a timely fashion, and overcome other difficulties inherent in developing and commercializing therapeutics, therapeutic devices and therapeutic regimens; market acceptance and penetration of BioTransplant's Eligix(TM) HDM Cell Separation Systems in the European Union; BioTransplant's ability to obtain and enforce the patent protection required for its products; and BioTransplant's ability to maintain collaborations and distribution arrangements with third parties. For a detailed discussion of these and other factors, see the section entitled ``Business - Factors Which May Affect Results'' in BioTransplant's current annual report on Form 10-K, as filed with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this news release. BioTransplant does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
(Tables Follow)
BIOTRANSPLANT INCORPORATED AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Amounts)
(Unaudited)
Quarter ended December 31, Quarter ended December 31,
2001 2000 2001 2000
Pro Forma
(a)
Revenues $478 $106 $478 $106
Expenses:
Cost of revenues 166 -- 166 --
Research and
development 3,070 4,003 3,070 4,003
General and
administrative 2,207 651 2,207 651
Amortization of
intangibles -- -- 1,101 --
Stock-based compensation -- -- 1,983 --
In-process research and
development (IPRD)
-- -- -- --
Total operating
expenses 5,443(a) 4,654 8,527 4,654
Interest income 89 290 89 290
Interest expense (51) (13) (51) (13)
Net loss $(4,927)(a) $(4,271) $(8,011) $(4,271)
Basic net loss
per common share $(0.25)(a) $(0.36) $(0.40) $(0.36)
Shares used in
computing basic
net loss per
common share 20,106 11,741 20,106 11,741
(a) Excludes non-cash stock-based compensation and amortization of intangibles. This presentation is illustrative only, and is not in accordance with generally accepted accounting principles.
BIOTRANSPLANT INCORPORATED AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Per Share Amounts)
(Unaudited)
Year ended December 31, Year ended December 31,
2001 2000 2001 2000
Pro Forma
(a)
Revenues $690 $4,563 $690 $4,563
Expenses:
Cost of revenues 225 -- 225 --
Research and
development 10,948 14,973 10,948 14,973
General and
administrative 4,854 2,544 4,854 2,544
Amortization of
intangibles -- -- 2,615 --
Stock-based compensation -- -- 5,081 --
In-process research and
development (IPRD)
-- -- 20,000 --
Total operating
expenses 16,027(a) 17,517 43,723 17,517
Interest income 530 1,334 530 1,334
Interest expense (143) (59) (143) (59)
Net loss $(14,950)(a) $(11,679) $(42,646) $(11,679)
Basic net loss
per common share $(0.91)(a) $(1.01) $(2.60) $(1.01)
Shares used in
computing basic
net loss per
common share 16,413 11,547 16,413 11,547
(a) Excludes non-cash IPRD, stock-based compensation and amortization of intangibles. This presentation is illustrative only, and is not in accordance with generally accepted accounting principles.
SELECTED BALANCE SHEET INFORMATION
(In Thousands)
December 31, December 31,
2001 2000
Cash, cash equivalents and investments $14,657 $14,873
Total assets 49,739 17,158
Stockholders' equity 38,879 14,422<<
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Cheers, Tuck |
