EX-99.1 2 a07-21552_1ex99d1.htm EX-99.1

Exhibit 99.1

Osiris Therapeutics Reports Second Quarter 2007 Financial Results

COLUMBIA,  Maryland — August 9, 2007 - Osiris Therapeutics, Inc. (NASDAQ:OSIR), a leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas, announced today its results for the second quarter ended June 30, 2007.

Highlights for the Second Quarter and to Date

-  Successfully raised $20 million in a private placement of common stock

-  Completed facility expansion for Osteocel®

-  Q2 Osteocel® sales increased 93% as compared to the prior year’s second quarter

-  Partnered with Genzyme Corp. to develop medical countermeasures for Nuclear and Radiological Threats

-  Awarded “Biotechnology Firm of the Year” by the Technology Council of Maryland

“Following our agreement with Genzyme, we are actively pursuing additional market opportunities for Prochymal,” said C. Randal Mills, Ph.D., President and Chief Executive Officer.  “We believe that these new efforts, coupled with our continued progress with the existing clinical programs for Prochymal, strategically position the company for better growth.”

Financial Highlights for Second Quarter

Sales of Osteocel were $3.3 million in the second quarter of 2007 compared to $1.7 million in the prior year’s second quarter. Other revenues were $0.3 million for both the second quarter of 2007 and 2006. Osiris reported a net loss of $10.5 million for the second quarter of 2007 compared to a net loss of $11.6 million for the second quarter of 2006. Research and development expenses were $10.6 million for the second quarter of 2007 compared to $10.9 million for the second quarter of 2006. The 2007 second quarter loss was largely the result of the continued advancement of the company’s clinical trials.  At the end of the second quarter Osiris had cash and short-term investments of $33.1 million.

General and administrative (G&A) expenses were $1.5 million for the second quarter of 2007 compared to $1.2 million for the second quarter of 2006. The increase in G&A expenses in the second quarter of 2007 was in part driven by costs to support business growth, and costs associated with becoming a public company.

Webcast and Conference Call

The Company has scheduled a webcast and conference call to discuss its financial results tomorrow, August 10th, at 9:00 AM EDT. To access the webcast, visit the Investor Relations section of the company’s website at http://investor.osiris.com/events.cfm. Alternatively, callers may participate in the conference call by dialing (800)289-0546 (U.S. participants) or (913) 981-5534 (international participants).

A replay of the conference call will be available approximately two hours after the completion of the call through August 24, 2007. Callers can access the replay by dialing (888) 203-1112 (U.S. participants) or (719) 457-0820 (international participants). The audio replay passcode is 4555023. To access a replay of the webcast, visit the Investor Relations section of the company’s website at http://investor.osiris.com/events.cfm.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is a leading stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. Osiris currently markets and sells Osteocel(R) for regenerating bone in orthopedic indications. Prochymal(TM) is in Phase III clinical trials and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product. The Company’s pipeline of internally developed biologic drug candidates under evaluation also includes Chondrogen(TM) for regenerating cartilage in the knee, and Provacel(TM), for repairing heart tissue following a heart attack. Osiris is a fully integrated company, having developed stem cell capabilities in research and development, manufacturing, marketing and distribution. Osiris has developed an extensive intellectual property portfolio to protect the company’s technology in the United States and a number of foreign countries including 47 U.S. and 167 foreign patents owned or licensed. More information can be found on the company’s website, www.Osiris.com. (OSIR-G)



Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements include statements about our expectations, beliefs, plans, objectives, intentions, assumptions and other statements that are not historical facts. Words or phrases such as “anticipate,” “believe,” “continue,” “ongoing,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project” or similar words or phrases, or the negatives of those words or phrases, may identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements regarding the following: our product development efforts; our clinical trials and anticipated regulatory requirements; the success of our product candidates in development; status of the regulatory process for our biologic drug candidates; implementation of our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for MSCs and biologic drug candidates; our cash needs; patents and proprietary rights; ability of our potential products to treat disease; our plans for sales and marketing; our plans regarding our facilities; types of regulatory frameworks we expect will be applicable to our potential products; and results of our scientific research. Forward-looking statements are subject to known and unknown risks and uncertainties and are based on potentially inaccurate assumptions that could cause actual results to differ materially from those expected or implied by the forward-looking statements. Our actual results could differ materially from those anticipated in forward-looking statements for many reasons, including the factors described in the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the United States Securities and Exchange Commission. Accordingly, you should not unduly rely on these forward-looking statements. We undertake no obligation to publicly revise any forward-looking statement to reflect circumstances or events after the date of this press release or to reflect the occurrence of unanticipated events.

For additional information, please contact Erica Elchin at 443.545.1834.



OSIRIS THERAPEUTICS, INC.
CONDENSED BALANCE SHEETS
(Amounts in thousands except per share amounts)

 

 

June 30,

 

December 31,

 

 

 

2007

 

2006

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash

 

$

662

 

$

714

 

Short-term investments

 

32,400

 

38,467

 

Accounts receivable

 

2,082

 

1,596

 

Inventory and other current assets

 

3,060

 

2,858

 

Total current assets

 

38,204

 

43,635

 

 

 

 

 

 

 

Property and equipment, net

 

5,391

 

3,942

 

Restricted cash

 

286

 

297

 

Deferred financing costs, net

 

447

 

567

 

Other assets

 

399

 

727

 

Total assets

 

$

44,727

 

$

49,168

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

5,809

 

$

8,339

 

Note payable, current portion

 

16

 

49

 

Capital lease obligations, current portion

 

1,183

 

1,129

 

Deferred revenue, current portion

 

873

 

952

 

Total current liabilities

 

7,881

 

10,469

 

 

 

 

 

 

 

Note payable, net of current portion

 

25,000

 

25,000

 

Capital lease obligations, net of current portion

 

290

 

895

 

Deferred revenue, net of current portion

 

—

 

397

 

Long-term interest payable and other liabilities

 

1,320

 

1,120

 

Total liabilities

 

34,491

 

37, 881

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock, $.001 par value, 90,000 shares authorized 29,230 and 27,321 shares outstanding in 2007 and 2006

 

29

 

27

 

Additional paid-in-capital

 

219,669

 

198,763

 

Accumulated deficit

 

(209,462

)

(187,503

)

Total stockholders’ equity

 

10,236

 

11,287

 

Total liabilities and stockholders’ equity

 

$

44,727

 

$

49,168

 

 



OSIRIS THERAPEUTICS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited) Amounts in thousands, except per share amounts

 

 

Three Months Ended

 

Six Months Ended

 

 

 

June 30,

 

June 30,

 

 

 

2007

 

2006

 

2007

 

2006

 

Product sales

 

$

3,252

 

$

1,689

 

$

5,252

 

$

2,794

 

Cost of goods sold

 

1,503

 

762

 

2,404

 

1,251

 

Gross profit

 

1,749

 

927

 

2,848

 

1,543

 

 

 

 

 

 

 

 

 

 

 

Revenue from collaborative research licenses and royalties

 

295

 

298

 

574

 

593

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

10,583

 

10,922

 

21,613

 

15,290

 

General and administrative

 

1,501

 

1,209

 

3,007

 

2,347

 

Total operating expenses

 

12,084

 

12,131

 

24,620

 

17,637

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(10,040

)

(10,906

)

(21,198

)

(15,501

)

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

(418

)

(699

)

(761

)

(1,225

)

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(10,458

)

$

(11,605

)

$

(21,959

)

$

(16,726

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.37

)

$

(1.27

)

$

(0.79

)

$

(1.83

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares (basic and diluted)

 

27,914

 

9,158

 

27,649

 

9,146

 

 



OSIRIS THERAPEUTICS, INC.
STATEMENTS OF CASH FLOWS
(Unaudited) Amounts in thousands

 

 

Six Months Ended June 30,

 

 

 

2007

 

2006

 

 

 

 

 

 

 

Cash flows from operations:

 

 

 

 

 

Net loss

 

$

(21,959

)

$

(16,726

)

Adjustments to reconcile net loss to net cash used in operations:

 

 

 

 

 

Depreciation and amortization

 

873

 

743

 

Non cash share-based payments

 

849

 

412

 

Non cash interest expense

 

120

 

381

 

Increase (decrease) in cash resulting from changes in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(486

)

170

 

Inventory and other current assets

 

(202

)

(1,473

)

Other assets

 

328

 

2

 

Accounts payable and accrued expenses

 

(2,130

)

2,610

 

Deferred revenue

 

(476

)

(476

)

Long-term interest payable and other liabilities

 

200

 

895

 

Net cash used in operations:

 

(22,883

)

(13,462

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of property and equipment

 

(2,322

)

(697

)

Redemption of short-term investments

 

24,797

 

15,009

 

Purchase of short-term investments

 

(18,730

)

—

 

Net cash provided by investing activities

 

3,745

 

14,312

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Principal payments on capital lease obligations and notes payable

 

(584

)

(534

)

Restricted cash

 

11

 

(119

)

Proceeds from the issuance of preferred and common stock, net of offering costs

 

20,059

 

20

 

Payment of debt financing costs

 

(400

)

—

 

Net cash provided by (used in) financing activities

 

19,086

 

(633

)

 

 

 

 

 

 

Net (decrease) increase in cash

 

(52

)

217

 

Cash at beginning of period

 

714

 

597

 

Cash at end of period

 

$

662

 

$

814