MacroPore Biosurgery Announces Second Quarter 2004 Financial Results.SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. -- MacroPore Biosurgery, Inc. (Frankfurt:XMP (X/Open Management Protocol) A high-level network management protocol governed by X/Open. Network management software written to the XMP interface is shielded from the details of the underlying SNMP or CMIP protocols. ) today announced financial results for the quarter ended June 30, 2004. Total revenues for the three months ended June 30, 2004 were $1.5 million compared to $2.9 million for the same period in 2003. In the second quarter of 2004, spine and orthopedic orthopedic /or·tho·pe·dic/ (-pe´dik) pertaining to the correction of deformities of the musculoskeletal system; pertaining to orthopedics. implants accounted for $0.9 million in revenue, compared to $2.0 million for the same period in 2003. Total revenues for the six months ended June 30, 2004 were $3.9 million compared to $4.8 million for the same period in 2003. In the first half of 2004, spine and orthopedic implants accounted for $2.5 million in revenue, compared to $3.0 million for the same period in 2003. Net loss for the three months ended June 30, 2004 was $3.8 million compared to a net loss of $2.1 million for the same period in 2003. Net loss for the six months ended June 30, 2004 was $2.3 million, after a $5.0 million gain related to the completion of the clinical research regarding Faster Resorbing Polymers, compared to $5.3 million for the same period in 2003. MacroPore Biosurgery ended the second quarter of 2004 with $18.0 million in cash and cash equivalents and short term investments, which includes the $7.0 million initial thin film product line sale payment received in May 2004 from MAST Biosurgery. Since the end of the quarter, MacroPore Biosurgery received $1.5 million from Senko Medical Trading Co. (Senko) as a fee for distribution rights for thin films products in Japan. Additionally, MacroPore Biosurgery was awarded a grant for the second phase of its National Institutes of Health (NIH "Not invented here." See digispeak. NIH - The United States National Institutes of Health. ) Small Business Innovation Research study. Phase II of the reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. was subsequently increased by the NIH to up to $850,000, subject to availability of funds and satisfactory progress. The funding from the NIH will be received during 2004 and 2005. In the second half of 2004, MacroPore Biosurgery expects to receive a $1.25 million milestone from Senko for submitting a thin film regulatory application in Japan and a $1.0 to $2.0 million milestone payment from Medtronic Medtronic Cardiology A major manufacturer of pacemakers, defibrillators, and other cardiac devices Inc. related to the transfer of know-how in connection with the 2002 sale of the craniomaxillofacial product line. "As previously disclosed, the time frame to achieve broad market adoption for our new class of spine and orthopedic products has been difficult to predict," said Christopher J. Calhoun, Chief Executive Officer of MacroPore Biosurgery. "However, our commitment to this product line is demonstrated by the recent regulatory milestones, which include a CE Mark for the first minimally invasive invasive /in·va·sive/ (-siv) 1. having the quality of invasiveness. 2. involving puncture of the skin or insertion of an instrument or foreign material into the body; said of diagnostic techniques. resorbable resorbable (rēsor´b lum·bar adj. Of, near, or situated in the part of the back and sides between the lowest ribs and the pelvis. interbody fusion device in Europe, a CE Mark for the first resorbable cervical cervical /cer·vi·cal/ (ser´vi-k'l) 1. pertaining to the neck. 2. pertaining to the neck or cervix of any organ or structure. cer·vi·cal adj. interbody device in Europe, and an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Clearance for the first resorbable spinal spinal /spi·nal/ (spi´n'l) 1. pertaining to a spine or to the vertebral column. 2. pertaining to the spinal cord's functioning independently from the brain. spi·nal adj. plate and screw screw, simple machine consisting essentially of a solid cylinder, usually of metal, around which an inclined plane winds spirally, either clockwise or counterclockwise. system with radiographic radiographic (rā´dēōgraf´ik), adj relating to the process of radiography, the finished product, or its use. visualization Using the computer to convert data into picture form. The most basic visualization is that of turning transaction data and summary information into charts and graphs. Visualization is used in computer-aided design (CAD) to render screen images into 3D models that can be viewed from all properties. These clearances provide additional rationale rationale (rash´ n the fundamental reasons used as the basis for a decision or action. for physician adoption of the HYDROSORB(TM) family of products. Simultaneously, we have continued to make progress within our regenerative re·gen·er·a·tive adj. 1. Of, relating to, or marked by regeneration. 2. Tending to regenerate. re·gen cell technology program. Since the close of the quarter, we received notice of award of the second phase of our NIH grant to study the potential role of adipose-derived regenerative cells in treating heart attack and expect to release the results of two pre-clinical trials later this year." Conference call information The management of MacroPore Biosurgery will host a conference call today at 4:30 pm Central Eastern Summer Time (CEST) or 10:30 a.m. Eastern Daylight Time (EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT ) to discuss the quarterly results. This conference call may be accessed from the investor relations Investor relations The process by which the corporation communicates with its investors. section of the Company's website, www.macropore.com. An archived version of the webcast will be available on the same website 60 minutes after the call. The audio replay will be archived for 24 hours Adv. 1. for 24 hours - without stopping; "she worked around the clock" around the clock, round the clock following the call and may be accessed by dialing +49 69 58 99 90 568 (PIN: 132681#) or 303-590-3000 (PIN: 11005031#). About MacroPore Biosurgery, Inc. MacroPore Biosurgery (Frankfurt:XMP) is focused on the discovery, development and commercialization of regenerative medicine technologies. We have two technology platforms, bioresorbable technology and regenerative cell technology. Our surgical implants, derived from our bioresorbable technology, represent one of the latest advancements in spine and orthopedic medicine. They are manufactured by us and distributed exclusively through Medtronic Sofamor Danek. Within our regenerative cell technology program, we are developing a system to isolate isolate /iso·late/ (i´sah-lat) 1. to separate from others. 2. a group of individuals prevented by geographic, genetic, ecologic, social, or artificial barriers from interbreeding with others of their kind. autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. , homologous-use, regenerative cells. Simultaneously, we are generating scientific knowledge through internal research to support the clinical use of these cells. Our most advanced research and development program is in the repair of cardiovascular cardiovascular /car·dio·vas·cu·lar/ (-vas´ku-ler) pertaining to the heart and blood vessels. car·di·o·vas·cu·lar adj. Abbr. tissues that are damaged after a heart attack. We are also researching applications in bone repair, spinal disc regeneration Regeneration (biology) The process by which an animal restores a lost part of its body. Broadly defined, the term can include wound healing, tissue repair, and many kinds of restorative activities. , and cosmetic cosmetic /cos·met·ic/ (koz-met´ik) 1. pertaining to cosmesis. 2. a beautifying substance or preparation. cos·met·ic n. and reconstructive surgery reconstructive surgery n. Plastic surgery. reconstructive surgery, n surgery to rebuild a structure for functional or esthetic reasons. . For further information please visit our web site http://www.macropore.com. Cautionary Statement Regarding Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. This press release may include forward-looking statements regarding events and trends which may affect MacroPore Biosurgery's future operating results and financial position. Such statements are subject to risks and uncertainties that could cause MacroPore Biosurgery's actual results and financial position to differ materially. Some of these risks and uncertainties are described (under the heading "Risk Factors") in our 2003 Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. annual report for the year ended December 31, 2003, which is available on our web site. MacroPore Biosurgery assumes no responsibility to update any revision of forward-looking statements to reflect events, trends or circumstances CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or after the date they are made.
Consolidated Condensed Balance Sheets
As of June 30, As of Dec. 31
2004 2003
------------ ------------
(Unaudited)
Assets
Current assets:
Cash and cash equivalents $ 2,093,000 $ 2,820,000
Short-term investments, available-for-
sale 15,940,000 11,448,000
Accounts receivable, net of allowance for
doubtful accounts of $32,000 and $62,000
in 2004 and 2003, respectively 1,457,000 1,291,000
Inventories 463,000 831,000
Other current assets 605,000 526,000
------------ ------------
Total current assets 20,558,000 16,916,000
Property and equipment, net 3,554,000 3,822,000
Other assets 209,000 332,000
Intangibles, net 2,257,000 2,392,000
Goodwill 4,387,000 4,627,000
------------ ------------
Total assets $30,965,000 $28,089,000
============ ============
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued expenses $ 2,427,000 $ 3,767,000
Current portion of long-term obligations 886,000 717,000
------------ ------------
Total current liabilities 3,313,000 4,484,000
Deferred gain on sale of assets, related
party 7,383,000 7,539,000
Deferred gain on sale of assets 6,266,000 --
Deferred income. 58,000 --
Long-term obligations, less current portion 1,328,000 1,157,000
------------ ------------
Total liabilities 18,348,000 13,180,000
Stockholders' equity:
Preferred stock, $0.001 par value;
5,000,000 shares authorized; -0- shares
issued and outstanding in 2004 and 2003 -- --
Common stock, $0.001 par value;
95,000,000 shares authorized; 16,800,018
and 16,777,644 shares issued and
13,930,834 and 14,195,062 shares
outstanding in 2004 and 2003,
respectively 17,000 17,000
Additional paid-in capital 74,734,000 74,698,000
Unearned compensation -- (109,000 )
Accumulated deficit (51,705,000 )(49,385,000 )
Treasury stock, at cost (10,405,000 ) (9,362,000 )
Treasury stock receivable -- (976,000 )
Accumulated other comprehensive income
(loss) (24,000 ) 26,000
------------ ------------
Total stockholders' equity 12,617,000 14,909,000
------------ ------------
Total liabilities and stockholders'
equity $30,965,000 $28,089,000
============ ============
Consolidated Condensed con·dense v. con·densed, con·dens·ing, con·dens·es v.tr. 1. To reduce the volume or compass of. 2. To make more concise; abridge or shorten. 3. Physics a. Statements of Operations and Comprehensive Income (Loss) (Unaudited)
For the Three Months For the Six Months
Ended June 30, Ended June 30,
------------------------- -------------------------
2004 2003 2004 2003
------------ ------------ ------------ ------------
Revenues:
Sales to related
party $ 894,000 $ 2,585,000 $ 2,815,000 $ 4,191,000
Sales to third
parties 636,000 318,000 977,000 641,000
Research grant 10,000 -- 100,000 --
------------ ------------ ------------ ------------
1,540,000 2,903,000 3,892,000 4,832,000
Cost of
revenues:
Cost of revenues
(including stockbased
compensation expense of
$1,000 and $3,000 for
the three months ended
June 30, 2004
and 2003; $3,000
and $6,000 for
the six months
ended June 30,
2004 and 2003,
respectively) 314,000 787,000 1,191,000 1,426,000
Inventory
provision -- -- 242,000 --
------------ ------------ ------------ ------------
Gross profit 1,226,000 2,116,000 2,459,000 3,406,000
------------ ------------ ------------ ------------
Operating expenses:
Research and
development,
excluding stock
based compensation
expense of $32,000
and $20,000 for
the three months
ended June 30,
2004 and 2003,
respectively;
$32,000 and
$39,000 for
the six months
ended June 30,
2004 and 2003,
respectively 2,668,000 2,107,000 5,175,000 4,258,000
Sales and marketing,
excluding stock
based compensation
expense of
$11,000 and $18,000
for the three months
ended June 30,
2004 and 2003,
respectively;
$22,000 and
$36,000 for
the six months
ended June 30,
2004 and 2003,
respectively 654,000 1,004,000 1,612,000 2,299,000
General and
administrative,
excluding stock
based compensation
expense of $36,000
and $174,000
for the three
months ended
June 30, 2004
and 2003,
respectively;
$71,000 and
$350,000 for
the six months
ended June 30,
2004 and 2003,
respectively 1,575,000 951,000 2,801,000 1,999,000
Stock based
compensation
(excluding cost of
revenues stock based
compensation) 79,000 212,000 125,000 425,000
Restructuring
charge 70,000 -- 70,000 --
------------ ------------ ------------ ------------
Total operating
expenses 5,046,000 4,274,000 9,783,000 8,981,000
------------ ------------ ------------ ------------
Other income (expense):
Gain on the
sale of assets,
related party 5,000,000
Interest income 57,000 105,000 112,000 247,000
Interest and
other (expenses),
net (47,000 ) (6,000 ) (108,000 ) (11,000 )
------------ ------------ ------------ ------------
Net loss (3,810,000 ) (2,059,000 ) (2,320,000 ) (5,339,000 )
------------ ------------ ------------ ------------
Other comprehensive
loss:
unrealized
holding loss (41,000 ) (11,000 ) (50,000 ) (52,000 )
------------ ------------ ------------ ------------
Comprehensive
loss $(3,851,000 )$(2,070,000 )$(2,370,000 )$(5,391,000 )
============ ============ ============ ============
Basic and
diluted net
loss per share $ (0.27 )$ (0.14 )$ (0.17 )$ (0.37 )
============ ============ ============ ============
Shares used in
calculating
basic and
diluted net
loss per share 13,920,186 14,540,734 13,933,111 14,532,716
============ ============ ============ ============
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