EX-99.1 2 a13-11630_1ex99d1.htm EX-99.1

Exhibit 99.1

 

GRAPHIC

 

Osiris Therapeutics Announces First Quarter 2013 Financial Results

 

COLUMBIA, Md. — May 7, 2013 - Osiris Therapeutics, Inc. (NASDAQ: 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 first quarter of 2013.

 

Highlights and Recent Developments

 

·      Launched CartiformTM, viable cartilage mesh for the treatment of articular cartilage injury.

 

·      Established and deployed a direct sales force for Grafix®, a premium cellular repair matrix for serious wounds including diabetic foot ulcers.

 

·      Received title of Orphan Drug designation from European Medicines Agency (EMA) for Prochymal®.

 

·      Defended a key patent, against an Australian opponent, covering the administration of mesenchymal stem cells for the treatment of inflammatory conditions involving the gastrointestinal tract.

 

·      Quarterly product revenue rose to $4.1 million— representing a 38% increase over the prior quarter.

 

·      Improved gross margin to 72% of revenue, with gross profit of $2.9M for the quarter.

 

·      Ended the quarter with a strong cash, receivables and short-term investment position of $34.9 million.

 

“Our team’s execution during the first quarter has given us a very strong start to 2013,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris.  “While we are pleased with our accomplishments, we are focused solely on the future.”

 

First Quarter Financial Results

 

Product revenues during the first quarter of 2013 were $4.1 million, compared to $1.1 million during the first quarter of 2012, an increase of 257%.  Gross margin during the first quarter was 72% compared to 66% during the first quarter of 2012.  Gross profit was $2.9 million during the first quarter of 2013 and $0.75 million during the same period of 2012. We reported a loss of $2.7 million in the first quarter of 2013.  As of March 31, 2013, Osiris had $34.9 million in cash, receivables and short-term investments.

 

Research and development expenses for the first quarter of 2013 were $3.0 million, compared to $4.0 million incurred in the first quarter of 2012. Selling, general and administrative expenses were $2.9 million for the first quarter of 2013, compared to $1.5 million for the same period of the prior year, reflecting our increased commercial activity.

 

Webcast and Conference Call

 

A webcast and conference call to discuss the financial results is scheduled for today, May 7, 2013 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). Note that a presentation will accompany the webcast.

 

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

 

7015 Albert Einstein Drive  ·  Columbia, Maryland  21046  · Ph 443.545.1800  ·  Fax 443.545.1701  ·  www.Osiris.com

 


 

About Osiris Therapeutics

 

Osiris Therapeutics, Inc., is the leading stem cell company, having developed the world’s first approved stem cell drug, Prochymal.  Osiris currently markets Grafix and Ovation® for wound and tissue repair, and Cartiform for cartilage repair. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of cell therapy products.  Osiris has developed an extensive intellectual property portfolio to protect the company’s technology, including 50 U.S. and 156 foreign patents.

 

Osiris, Prochymal, Chondrogen, 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, Ovation and Cartiform); 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.

 

For additional information, please contact:

 

 Aziz Ahmad

Osiris Therapeutics, Inc.

(443) 545-1834

OsirisPR@Osiris.com

 


 

OSIRIS THERAPEUTICS, INC.

Condensed Balance Sheets

Amounts in thousands

 

 

 

March 31, 2013

 

December 31, 2012

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash

 

$

1,287

 

$

1,854

 

Investments available for sale

 

28,292

 

32,238

 

Accounts receivable, net

 

5,346

 

3,063

 

Inventory

 

1,611

 

1,278

 

Prepaid expenses and other current assets

 

462

 

603

 

Total current assets

 

36,998

 

39,036

 

 

 

 

 

 

 

Property and equipment, net

 

2,037

 

2,111

 

Restricted cash

 

317

 

317

 

Total assets

 

$

39,352

 

$

41,464

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued expenses

 

$

4,985

 

$

4,999

 

Capital lease obligations, current portion

 

44

 

44

 

Total current liabilities

 

5,029

 

5,043

 

 

 

 

 

 

 

Long-term portion of capital lease obligations

 

151

 

162

 

Other long-term liabilities

 

350

 

369

 

Total liabilities

 

5,530

 

5,574

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

Common stock, $.001 par value, 90,000 shares authorized, 32,930 shares outstanding - 2013, 32,881 shares outstanding - 2012

 

33

 

33

 

Additional paid-in-capital

 

279,911

 

279,269

 

Accumulated other comprehensive income (loss)

 

5

 

(20

)

Accumulated deficit

 

(246,127

)

(243,392

)

Total stockholders’ equity

 

33,822

 

35,890

 

Total liabilities and stockholders’ equity

 

$

39,352

 

$

41,464

 

 


 

OSIRIS THERAPEUTICS, INC.

Condensed Statements of Operations

Unaudited

Amounts in thousands, except per share data

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2013

 

2012

 

 

 

 

 

 

 

Product revenues

 

$

4,055

 

$

1,137

 

Cost of product revenues

 

1,135

 

387

 

Gross profit

 

2,920

 

750

 

 

 

 

 

 

 

Revenue from collaborative research agreements and royalties

 

186

 

3,446

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

Research and development

 

2,981

 

3,963

 

Selling, general and administrative

 

2,889

 

1,523

 

 

 

5,870

 

5,486

 

 

 

 

 

 

 

Loss from operations

 

(2,764

)

(1,290

)

 

 

 

 

 

 

Other income, net

 

29

 

18

 

 

 

 

 

 

 

Loss before income taxes

 

(2,735

)

(1,272

)

 

 

 

 

 

 

Income tax benefit

 

—

 

—

 

 

 

 

 

 

 

Net loss

 

$

(2,735

)

$

(1,272

)

 

 

 

 

 

 

Basic and diluted loss per share

 

$

(0.08

)

$

(0.04

)

 

 

 

 

 

 

Weighted average common shares (basic and diluted)

 

32,912

 

32,830

 

 


 

OSIRIS THERAPEUTICS, INC.

Condensed Statements of Cash Flows

Unaudited

Amounts in thousands

 

 

 

Three months ended March31,

 

 

 

March 31,

 

 

 

2013

 

2012

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(2,735

)

$

(1,272

)

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

 

 

 

 

 

Depreciation and amortization

 

185

 

177

 

Non cash share-based payments

 

473

 

385

 

Provision for bad debts

 

22

 

—

 

Changes in operating assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(2,305

)

(269

)

Inventory

 

(333

)

352

 

Prepaid expenses, and other current assets

 

141

 

(166

)

Accounts payable and accrued expenses

 

(33

)

101

 

Deferred revenue

 

—

 

(3,333

)

Net cash used in operating activities

 

(4,585

)

(4,025

)

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Purchases of property and equipment

 

(111

)

(20

)

Proceeds from sale of investments available for sale

 

4,000

 

3,985

 

Purchases of investments available for sale

 

(29

)

(15

)

Net cash provided by investing activities

 

3,860

 

3,950

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Principal payments on capital lease obligations

 

(11

)

—

 

Proceeds from the issuance of common stock, net

 

169

 

—

 

Net cash provided by financing activities

 

158

 

—

 

 

 

 

 

 

 

Net decrease in cash

 

(567

)

(75

)

Cash at beginning of period

 

1,854

 

1,661

 

 

 

 

 

 

 

Cash at end of period

 

$

1,287

 

$

1,586