EX-99.1 2 a04-9641_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

Contact:

 

 

 

Tom Baker

Stefanie Bacher

Media/U.S. Investors

European Investors

Tel. +1-858-458-0900

Tel. +1-858-362-0365

tbaker@macropore.com

sbacher@macropore.com

 

MacroPore Biosurgery Announces Second Quarter 2004 Financial Results

 

San Diego, CA, August 16, 2004 - MacroPore Biosurgery, Inc. (Frankfurt: XMP) 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 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) Small Business Innovation Research study, which was announced to be worth up to $750,000. Phase II of the reimbursement was subsequently increased by the NIH 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 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 resorbable lumbar interbody fusion device in Europe, a CE Mark for the first resorbable cervical interbody device in Europe, and an FDA Clearance for the first resorbable spinal plate and screw system with radiographic visualization properties. These clearances provide additional rationale for physician adoption of the HYDROSORB™ family of products. Simultaneously, we have continued to make progress within our regenerative 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 am Eastern Daylight Time (EDT) to discuss the quarterly results. This conference call may be accessed from the investor relations 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 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 autologous, 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 tissues that are damaged after a heart attack. We are also researching applications in bone repair, spinal disc regeneration, and cosmetic and reconstructive surgery. For further information please visit our web site http://www.macropore.com.

 

Cautionary Statement Regarding Forward-Looking Statements

 

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 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 after the date they are made.

 

###

 



 

MACROPORE BIOSURGERY, INC.

CONSOLIDATED CONDENSED BALANCE SHEETS

 

 

 

As of June 30,
2004

 

As of December 31,
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

 

 



 

MACROPORE BIOSURGERY, INC.

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS)

(UNAUDITED)

 

 

 

For the Three Months
Ended June 30,

 

For the Six Months
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 stock based 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