Osiris Therapeutics Reports Third Quarter 2012 Financial Results

Osiris Therapeutics Reports Third Quarter 2012 Financial Results

Biosurgery sales up 6-fold over previous year - Osiris regains worldwide rights to Prochymal

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics, Inc. (NAS: OSIR) , the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets, announced today its results for the third quarter ended September 30, 2012.


Highlights and Recent Developments

  • Regained worldwide rights to Prochymal® and Chondrogen®

  • Reported $2.2 million of revenue from our Biosurgery products, Grafix and Ovation, during the third quarter - a 32% increase over the prior quarter and a greater than 6-fold increase over 3Q 2011.

  • Reported cash, receivables and short-term investments of $39.4 million as of September 30, 2012.

  • Promoted Lode Debrabandere, Ph.D. to the role of Chief Operating Officer.

  • Elected Hans Klingemann, M.D., Ph.D. to the position of Director to serve as a member of the company's Audit, Compensation and Nominating Committees.

  • Received notification from Swissmedic that Prochymal will be evaluated under its Rapid Authorization Procedures, a designation that cuts the evaluation period for promising new drugs in half.

  • Submitted a full proposal to the Biomedical Advanced Research and Development Authority (BARDA) after being selected for a Broad Agency Announcement (BAA) to fund advanced research and development of countermeasures, specifically for the use of Grafix in mass casualty thermal burn injuries.

  • Increased our U.S. intellectual property estate to 51 issued patents (154 worldwide). Recent additions cover the use of MSCs for graft-versus-host disease and inflammatory conditions, as well as methods of manufacturing and MSC quality.

"We are very pleased with how all aspects of our business performed this quarter," said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. "We have a very unique and exciting opportunity ahead of us. As we transition into a fully commercial entity, we will not relinquish the scientific leadership position we have created in cell therapy. Instead, we are leveraging our highly sophisticated understanding of this powerful technology to favorably differentiate our best-in-class products within the market place."

Third Quarter Financial Results

Biosurgery product revenue rose 32% from the previous quarter to $2.2 million and over 6-fold from the third quarter of 2011. Gross profit from product sales rose to $1.4 million for the quarter or 66% of revenue. As of September 30, 2012, Osiris had $39.4 million of cash, receivables and short-term investments.

Research and development expenses for the third quarter of 2012 were $3.0 million, compared to $5.0 million incurred in the third quarter of 2011. General and administrative (G&A) expenses were $1.6 million for the third quarter of 2012 compared to $1.4 million for the same period of the prior year. Net cash used in operations for the three months ended September 30, 2012 was $1.6 million.

Webcast and Conference Call

A webcast and conference call to discuss the financial results is scheduled for today, November 5, 2012 at 9:00 a.m. ET. 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 (877) 303-6133 (U.S. participants) or (970) 315-0493 (international participants).

An archive of the webcast will be available approximately two hours after the completion of the call through November 12, 2012. To access the archived webcast, visit the Investor Relations section of the company's website at http://investor.osiris.com/events.cfm.

About Osiris Therapeutics

Osiris Therapeutics, Inc., having developed the world's first approved stem cell drug, Prochymal®, is the leading stem cell company. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. In Biosurgery, Osiris currently markets Grafix® for burns and chronic wounds, and Ovation® for orthopedic applications. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 51 U.S. and 154 foreign patents.

Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. 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 may include, without limitation, statements regarding any of the following: our product development efforts; our clinical trials and anticipated regulatory requirements, and our ability to successfully navigate these 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 mesenchymal stem cells and biologic drug candidates and marketed Biosurgery products (including Prochymal®, Chondrogen®, Grafix® and Ovation®); our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to treat disease; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, products to meet demand; our costs to comply with governmental regulations; our plans for sales and marketing; our plans regarding facilities; types of regulatory frameworks we expect will be applicable to our products and 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 and other Periodic Reports filed on Form 10-Q, 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.

OSIRIS THERAPEUTICS, INC.

Condensed Balance Sheets

Amounts in thousands, except per share data

September 30, 2012

December 31, 2011

(unaudited)

Assets

Current assets:

Cash

$

1,056

$

1,661

Investments available for sale

36,159

45,604

Accounts receivable, net

2,231

728

Inventory

922

767

Deferred tax asset

-

2,188

Prepaid expenses and other current assets

1,062

470

Total current assets

41,430

51,418

Property and equipment, net

2,220

2,463

Restricted cash

318

392

Total assets

$

43,968

$

54,273

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable and accrued expenses

$

5,002

$

4,692

Capital lease obligations, current portion

44

-

Deferred revenue, current portion

-

3,333

Total current liabilities

5,046

8,025

Long-term portion of capital lease obligations

173

-

Other long-term liabilities

387

430

Total liabilities

5,606

8,455

Stockholders' equity

Common stock, $.001 par value, 90,000 shares

authorized, 32,874 shares outstanding - 2012,

32,828 shares outstanding - 2011

33

33

Additional paid-in-capital

279,092

278,092

Accumulated other comprehensive income

15

20

Accumulated deficit

(240,778

)

(232,327

)

Total stockholders' equity

38,362

45,818

Total liabilities and stockholders' equity

$

43,968

$

54,273

OSIRIS THERAPEUTICS, INC.

Condensed Statements of Operations

(Unaudited)

Amounts in thousands, except per share data

Three Months Ended

Nine Months Ended

September 30,

September 30,

2012

2011

2012

2011

Product revenues

$

2,151

$

331

$

4,914

$

498

Cost of product revenues

732

139

1,671

209

Gross profit

1,419

192

3,243

289

Revenue from collaborative research agreements and royalties

232

10,242

3,776

30,861

Operating expenses:

Research and development

2,983

5,018

11,018

14,938

General and administrative

1,600

1,429

4,541

6,405

4,583

6,447

15,559

21,343

(Loss) income from operations

(2,932

)

3,987

(8,540

)

9,807

Other income, net

13

26

52

80

(Loss) income before income taxes

(2,919

)

4,013

(8,488

)

9,887

Income tax benefit (expense)

5

-

37

(43

)

Net (loss) income

$

(2,914

)

$

4,013

$

(8,451

)

$

9,844

Basic (loss) earnings per share

$

(0.09

)

$

0.12

$

(0.26

)

$

0.30

Diluted (loss) earnings per share

$

(0.09

)

$

0.12

$

(0.26

)

$

0.30

Weighted average common shares (basic)

32,871

32,826

32,854

32,818

Weighted average common shares (diluted)

32,871

33,121

32,854

33,121

OSIRIS THERAPEUTICS, INC.

Statements of Cash Flows

(Unaudited)

Amounts in thousands

Nine months ended,

Sept 30,

2012

2011

Cash flows from operating activities:

Net (loss) income

$

(8,451

)

$

9,844

Adjustments to reconcile net (loss) income

to net cash used in operating activities:

Depreciation and amortization

528

560

Non cash share-based payments

952

1,341

Provision for bad debts

11

-

Non cash expense- extension of expiration date of warrant to related party

-

1,740

Changes in operating assets and liabilities:

Accounts receivable

(1,514

)

468

Inventory, prepaid expenses, and other current assets

(747

)

733

Deferred tax assets

2,188

-

Other assets

-

165

Accounts payable and accrued expenses

267

21

Deferred revenue

(3,333

)

(30,720

)

Net cash used in operating activities

(10,099

)

(15,848