Exhibit 99.1
Osiris Therapeutics Announces Second Quarter 2013 Financial Results
COLUMBIA, Md. — August 5, 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 second quarter of 2013.
Highlights and Recent Developments
· Product revenue for the quarter rose to $5.3 million - up 231% from the second quarter of 2012.
· Gross profit increased to $3.8M for the quarter, on 245% from the second quarter of 2012.
· Significantly advanced our multicenter, randomized, controlled trial evaluating the efficacy and safety of Grafix® in diabetic foot ulcers — now nearing completion of patient enrollment.
· Expanded our overall commercial infrastructure, including the addition of direct sales representatives in sports medicine for Cartiform®.
· Completed a 67 patient clinical evaluation of Grafix across multiple wound types, demonstrating an overall closure rate of 81% with a 71% closure rate in difficult to treat venous leg ulcers.
· Ended the quarter with a strong cash, receivables and short-term investment position of $33.6 million.
“We are very pleased with the return our new sales team is delivering on our investments in commercial infrastructure as demonstrated by our continued revenue growth,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “We are also excited about the progress of Protocol 302, our randomized, controlled clinical trial evaluating Grafix for chronic diabetic foot ulcers. By balancing our commercial and developmental activities, we continue to advance towards our goal of creating a profitable business in cell therapy by providing best-in-class products and service.”
Second Quarter Financial Results
Product revenues during the second quarter of 2013 were $5.3 million, compared to $1.6 million during the second quarter of 2012, an increase of 231%. Gross margin during the second quarter was 72% compared to 66% during the second quarter of 2012. Gross profit was $3.8 million during the second quarter of 2013 and $1.1 million during the same period of 2012. The net loss was $3.8 million in the second quarter of 2013 compared to $4.3 M during the second quarter of 2012. As of June 30, 2013, Osiris had $33.6 million in cash, receivables and short-term investments.
Research and development expenses for the second quarter of 2013 were $3.3 million, decreased from the $4.1 million incurred in the second quarter of 2012. As a result of our increased commercial activity, our selling, general and administrative expenses were $4.4 million for the second quarter of 2013, compared to $1.4 million for the same period of the prior year.
Webcast and Conference Call
A webcast and conference call to discuss the financial results is scheduled for today, August 5, 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.
7015 Albert Einstein Drive · Columbia, Maryland 21046 · Ph 443.545.1800 · Fax 443.545.1701 · www.Osiris.com
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.
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 51 U.S. and 162 foreign patents.
Osiris, Prochymal, Chondrogen, Grafix, Ovation and Cartiform 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
|
|
|
June 30, 2013 |
|
December 31, 2012 |
| ||
|
|
|
(unaudited) |
|
|
| ||
|
Assets |
|
|
|
|
| ||
|
Current assets: |
|
|
|
|
| ||
|
Cash |
|
$ |
1,579 |
|
$ |
1,854 |
|
|
Investments available for sale |
|
25,626 |
|
32,238 |
| ||
|
Accounts receivable, net |
|
6,406 |
|
3,063 |
| ||
|
Inventory |
|
1,696 |
|
1,278 |
| ||
|
Prepaid expenses and other current assets |
|
356 |
|
603 |
| ||
|
Total current assets |
|
35,663 |
|
39,036 |
| ||
|
|
|
|
|
|
| ||
|
Property and equipment, net |
|
2,040 |
|
2,111 |
| ||
|
Restricted cash |
|
317 |
|
317 |
| ||
|
Total assets |
|
$ |
38,020 |
|
$ |
41,464 |
|
|
|
|
|
|
|
| ||
|
Liabilities and Stockholders’ Equity |
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Current liabilities: |
|
|
|
|
| ||
|
Accounts payable, accrued expenses, and other current liabilities |
|
$ |
6,826 |
|
$ |
4,999 |
|
|
Capital lease obligations, current portion |
|
45 |
|
44 |
| ||
|
Total current liabilities |
|
6,871 |
|
5,043 |
| ||
|
|
|
|
|
|
| ||
|
Long-term portion of capital lease obligations |
|
140 |
|
162 |
| ||
|
Other long-term liabilities |
|
329 |
|
369 |
| ||
|
Total liabilities |
|
7,340 |
|
5,574 |
| ||
|
|
|
|
|
|
| ||
|
Stockholders’ equity |
|
|
|
|
| ||
|
Common stock, $.001 par value, 90,000 shares authorized, 32,989 shares outstanding - 2013, 32,881 shares outstanding - 2012 |
|
33 |
|
33 |
| ||
|
Additional paid-in-capital |
|
280,616 |
|
279,269 |
| ||
|
Accumulated other comprehensive loss |
|
(86 |
) |
(20 |
) | ||
|
Accumulated deficit |
|
(249,883 |
) |
(243,392 |
) | ||
|
Total stockholders’ equity |
|
30,680 |
|
35,890 |
| ||
|
Total liabilities and stockholders’ equity |
|
$ |
38,020 |
|
$ |
41,464 |
|
OSIRIS THERAPEUTICS, INC.
Condensed Statements of Operations
Unaudited
Amounts in thousands, except per share data
|
|
|
Three Months Ended |
|
Six Months Ended |
| ||||||||
|
|
|
June 30, |
|
June 30, |
| ||||||||
|
|
|
2013 |
|
2012 |
|
2013 |
|
2012 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Product revenues |
|
$ |
5,291 |
|
$ |
1,626 |
|
$ |
9,346 |
|
$ |
2,763 |
|
|
Cost of product revenues |
|
1,482 |
|
552 |
|
2,617 |
|
939 |
| ||||
|
Gross profit |
|
3,809 |
|
1,074 |
|
6,729 |
|
1,824 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Revenue from collaborative research agreements and royalties |
|
136 |
|
98 |
|
322 |
|
3,544 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
| ||||
|
Research and development |
|
3,328 |
|
4,072 |
|
6,309 |
|
8,035 |
| ||||
|
Selling, general and administrative |
|
4,398 |
|
1,418 |
|
7,287 |
|
2,941 |
| ||||
|
|
|
7,726 |
|
5,490 |
|
13,596 |
|
10,976 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Loss from operations |
|
(3,781 |
) |
(4,318 |
) |
(6,545 |
) |
(5,608 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Other income, net |
|
25 |
|
21 |
|
54 |
|
39 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Loss before income taxes |
|
(3,756 |
) |
(4,297 |
) |
(6,491 |
) |
(5,569 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income tax benefit |
|
— |
|
32 |
|
— |
|
32 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Net loss |
|
$ |
(3,756 |
) |
$ |
(4,265 |
) |
$ |
(6,491 |
) |
$ |
(5,537 |
) |
|
|
|
|
|
|
|
|
|
|
| ||||
|
Basic and diluted net loss per share |
|
$ |
(0.11 |
) |
$ |
(0.13 |
) |
$ |
(0.20 |
) |
$ |
(0.17 |
) |
|
|
|
|
|
|
|
|
|
|
| ||||
|
Weighted average common shares (basic and diluted) |
|
32,958 |
|
32,860 |
|
32,935 |
|
32,845 |
| ||||
OSIRIS THERAPEUTICS, INC.
Condensed Statements of Cash Flows
Unaudited
Amounts in thousands
|
|
|
Six months ended |
| ||||
|
|
|
June 30, |
| ||||
|
|
|
2013 |
|
2012 |
| ||
|
Cash flows from operating activities: |
|
|
|
|
| ||
|
Net loss |
|
$ |
(6,491 |
) |
$ |
(5,537 |
) |
|
Adjustments to reconcile net loss to net cash used in operations: |
|
|
|
|
| ||
|
Depreciation and amortization |
|
369 |
|
348 |
| ||
|
Non cash share-based payments |
|
766 |
|
687 |
| ||
|
Provision for bad debts |
|
(25 |
) |
11 |
| ||
|
Changes in operating assets and liabilities: |
|
|
|
|
| ||
|
Accounts receivable |
|
(3,318 |
) |
(676 |
) | ||
|
Inventory |
|
(418 |
) |
292 |
| ||
|
Prepaid expenses, and other current assets |
|
247 |
|
(713 |
) | ||
|
Accounts payable, accrued expenses, and other current liabilities |
|
1,788 |
|
449 |
| ||
|
Deferred revenue |
|
— |
|
(3,333 |
) | ||
|
Net cash used in operating activities |
|
(7,082 |
) |
(8,472 |
) | ||
|
|
|
|
|
|
| ||
|
Cash flows from investing activities: |
|
|
|
|
| ||
|
Purchases of property and equipment |
|
(298 |
) |
(38 |
) | ||
|
Proceeds from sale of investments available for sale |
|
6,600 |
|
7,985 |
| ||
|
Purchases of investments available for sale |
|
(54 |
) |
(33 |
) | ||
|
Net cash provided by investing activities |
|
6,248 |
|
7,914 |
| ||
|
|
|
|
|
|
| ||
|
Cash flows from financing activities: |
|
|
|
|
| ||
|
Principal payments on capital lease obligations |
|
(22 |
) |
— |
| ||
|
Proceeds from the issuance of common stock, net |
|
581 |
|
6 |
| ||
|
Net cash provided by financing activities |
|
559 |
|
6 |
| ||
|
|
|
|
|
|
| ||
|
Net decrease in cash |
|
(275 |
) |
(552 |
) | ||
|
Cash at beginning of period |
|
1,854 |
|
1,661 |
| ||
|
|
|
|
|
|
| ||
|
Cash at end of period |
|
$ |
1,579 |
|
$ |
1,109 |
|