Attached files
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| 8-K - 8-K - OSIRIS THERAPEUTICS, INC. | a11-23820_18k.htm |
Exhibit 99.1
Osiris Therapeutics Reports Second Quarter 2011 Financial Results
COLUMBIA, Md. – August 5, 2011 - Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat medical conditions in inflammatory and cardiovascular disease areas and wound healing, announced today its results for the second quarter ended June 30, 2011.
Highlights and Recent Developments
· Received a request from Health Canada for additional information surrounding the New Drug Submission (NDS) for Prochymal as well as questions regarding post marketing commitments.
· Initiated the expansion of the company’s commercial infrastructure for our lead products Grafix® and Ovation®.
· Inspected by the U.S. Food and Drug Administration with no deficiencies noted.
· Reported net income of $1.8 million for the quarter; $0.05 per diluted common share.
· Reported cash, receivables and short-term investments of $57.8 million as of June 30, 2011.
“Osiris continues to make steady progress in both Therapeutics and Biosurgery,” stated C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris Therapeutics. “We are starting to build the necessary foundation for the commercial success of our Biosurgery division and continue to work towards our goal of making Prochymal the world’s first approved stem cell therapy.”
Second Quarter Financial Results
Net income for the second quarter of 2011 was $1.8 million compared to $1.7 million in the second quarter of 2010. Revenues were $10.4 million in the second quarter of 2011, consisting primarily of the amortization of license fees from our collaboration agreements. Revenues in the second quarter of 2010 were $10.3 million. As of June 30, 2011, Osiris had $57.8 million of cash, receivables and short-term investments.
Research and development expenses for the second quarter of 2011 were $5.2 million, compared to $6.5 million incurred in the second quarter of 2010. General and administrative expenses were $3.3 million for the second quarter of 2011 compared to $1.6 million for the same period of the prior year, including a one-time $1.7 million non-cash charge related to the warrant extension approved by our stockholders in May 2011. Net cash used in operations for the three months ended June 30, 2011 was $5.5 million.
Webcast and Conference Call
A webcast and conference call to discuss the financial results is scheduled for today, August 5, 2011 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).
A replay of the conference call will be available approximately two hours after the completion of the call through August 11, 2011. Callers can access the replay by dialing (855) 859-2056 (U.S. participants) or (404) 537-3406 (international participants). The audio replay confirmation code is 86745154. 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 the leading stem cell company focused on developing products to treat serious medical conditions in the inflammatory, autoimmune, orthopedic, wound care and cardiovascular areas. The company’s pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. 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 47 U.S. and 143 foreign patents.
Osiris and Genzyme formed a strategic alliance for the development and commercialization of Prochymal and Chondrogen. Under the terms of the agreement, Osiris retains commercialization rights to Prochymal and Chondrogen in the United States and Canada. Genzyme holds these rights in all other countries except Japan, where JCR Pharmaceuticals holds rights to Prochymal for the treatment of patients with hematological malignancies.
Osiris and Prochymal 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 include, but are not limited to, statements regarding the following: our product development efforts; our clinical trials and anticipated regulatory requirements and the 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
7015 Albert Einstein Drive · Columbia, Maryland 21046 · Ph 443.545.1800 · Fax 443.545.1701 · www.Osiris.com
our corporate strategy; our financial performance; our product research and development activities and projected expenditures, including our anticipated timeline and clinical strategy for Prochymal, Chondrogen and our other MSC and biologic drug candidates; our cash needs; patents and proprietary rights; the safety and ability of our potential products to treat disease and the results of our scientific research; 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. Risks and uncertainties related to our Collaboration Agreement with Genzyme for the development and commercialization of Prochymal and Chondrogen include, among others: typical business transactional risks; risks related to product development and clinical trial design, performance and completion; uncertainty of the success of Prochymal and Chondrogen in clinical trials and their ability to treat disease; Genzyme’s early termination and opt-out rights; the ability of Osiris and Genzyme to successfully navigate regulatory requirements and to manufacture and commercialize products; and the uncertainty as to our ability to successfully perform under the collaborative arrangement and earn milestone and royalty payments thereunder. 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:
Erica Elchin
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com
OSIRIS THERAPEUTICS, INC.
Condensed Balance Sheets
Amounts in thousands
|
|
|
June 30, 2011 |
|
December 31, 2010 |
| ||
|
|
|
(unaudited) |
|
|
| ||
|
Assets |
|
|
|
|
| ||
|
Current assets: |
|
|
|
|
| ||
|
Cash |
|
$ |
1,510 |
|
$ |
1,442 |
|
|
Investments available for sale |
|
54,650 |
|
66,166 |
| ||
|
Accounts and other receivables |
|
1,643 |
|
1,928 |
| ||
|
Inventory |
|
623 |
|
510 |
| ||
|
Deferred tax asset |
|
2,192 |
|
3,170 |
| ||
|
Prepaid expenses and other current assets |
|
743 |
|
736 |
| ||
|
Total current assets |
|
61,361 |
|
73,952 |
| ||
|
|
|
|
|
|
| ||
|
Property and equipment, net |
|
2,792 |
|
3,127 |
| ||
|
Restricted cash |
|
521 |
|
521 |
| ||
|
Other assets |
|
35 |
|
184 |
| ||
|
Total assets |
|
$ |
64,709 |
|
$ |
77,784 |
|
|
|
|
|
|
|
| ||
|
Liabilities and Stockholders’ Equity |
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Current liabilities: |
|
|
|
|
| ||
|
Accounts payable and accrued expenses |
|
$ |
4,386 |
|
$ |
5,569 |
|
|
Deferred revenue, current portion |
|
23,813 |
|
40,960 |
| ||
|
Total current liabilities |
|
28,199 |
|
46,529 |
| ||
|
|
|
|
|
|
| ||
|
Deferred revenue, net of current portion |
|
— |
|
3,333 |
| ||
|
Other long-term liabilities |
|
453 |
|
465 |
| ||
|
Total liabilities |
|
28,652 |
|
50,327 |
| ||
|
|
|
|
|
|
| ||
|
Stockholders’ equity |
|
|
|
|
| ||
|
Common stock, $.001 par value, 90,000 shares authorized, 32,822 shares outstanding - 2011, 32,794 shares outstanding - 2010 |
|
33 |
|
33 |
| ||
|
Additional paid-in-capital |
|
277,381 |
|
274,646 |
| ||
|
Accumulated other comprehensive income (loss) |
|
31 |
|
(3 |
) | ||
|
Accumulated deficit |
|
(241,388 |
) |
(247,219 |
) | ||
|
Total stockholders’ equity |
|
36,057 |
|
27,457 |
| ||
|
Total liabilities and stockholders’ equity |
|
$ |
64,709 |
|
$ |
77,784 |
|
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, |
| ||||||||
|
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Product sales |
|
$ |
130 |
|
$ |
— |
|
$ |
167 |
|
$ |
— |
|
|
Cost of goods sold |
|
55 |
|
— |
|
70 |
|
— |
| ||||
|
Gross profit |
|
75 |
|
— |
|
97 |
|
— |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Revenue from collaborative research agreements, government contract and royalties |
|
10,224 |
|
10,304 |
|
20,619 |
|
21,681 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
| ||||
|
Research and development |
|
5,209 |
|
6,456 |
|
9,920 |
|
3,016 |
| ||||
|
General and administrative |
|
3,280 |
|
1,602 |
|
4,976 |
|
3,409 |
| ||||
|
|
|
8,489 |
|
8,058 |
|
14,896 |
|
16,425 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income from operations |
|
1,810 |
|
2,246 |
|
5,820 |
|
5,256 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Other income, net |
|
25 |
|
36 |
|
54 |
|
124 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income before income taxes |
|
1,835 |
|
2,282 |
|
5,874 |
|
5,380 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income tax expense |
|
(43 |
) |
(535 |
) |
(43 |
) |
(1,217 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Net income |
|
$ |
1,792 |
|
$ |
1,747 |
|
$ |
5,831 |
|
$ |
4,163 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Basic earnings per share |
|
$ |
0.05 |
|
$ |
0.05 |
|
$ |
0.18 |
|
$ |
0.13 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Diluted earnings per share |
|
$ |
0.05 |
|
$ |
0.05 |
|
$ |
0.18 |
|
$ |
0.13 |
|
|
|
|
|
|
|
|
|
|
|
| ||||
|
Weighted average common shares (basic) |
|
32,821 |
|
32,780 |
|
32,814 |
|
32,777 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Weighted average common shares (diluted) |
|
33,134 |
|
33,084 |
|
33,124 |
|
33,086 |
| ||||
OSIRIS THERAPEUTICS, INC.
Statements of Cash Flows
Amounts in thousands
|
|
|
Six Months Ended |
| ||||
|
|
|
June 30, |
| ||||
|
|
|
2011 |
|
2010 |
| ||
|
Cash flows from operating activities: |
|
|
|
|
| ||
|
Continuing operations |
|
|
|
|
| ||
|
Net income |
|
$ |
5,831 |
|
$ |
4,163 |
|
|
Adjustments to reconcile net income to net cash used in continuing operations: |
|
|
|
|
| ||
|
Depreciation and amortization |
|
375 |
|
378 |
| ||
|
Non cash share-based payments |
|
994 |
|
856 |
| ||
|
Non cash expense- extension of expiration date warrant to related party |
|
1,740 |
|
— |
| ||
|
Changes in operating assets and liabilities: |
|
|
|
|
| ||
|
Accounts and other receivables |
|
1,263 |
|
815 |
| ||
|
Prepaid and other expenses, inventory, and other current assets |
|
(120 |
) |
36 |
| ||
|
Other assets |
|
149 |
|
111 |
| ||
|
Accounts payable and accrued expenses |
|
(1,195 |
) |
(2,034 |
) | ||
|
Deferred revenue |
|
(20,480 |
) |
(20,533 |
) | ||
|
Net cash used in continuing operations |
|
(11,443 |
) |
(16,208 |
) | ||
|
Discontinued operations |
|
|
|
|
| ||
|
Changes in operating assets and liabilities: |
|
|
|
|
| ||
|
Accounts payable and accrued expenses |
|
— |
|
(412 |
) | ||
|
Net cash used in discontinued operations |
|
— |
|
(412 |
) | ||
|
|
|
|
|
|
| ||
|
Net cash used in operating activities |
|
(11,443 |
) |
(16,620 |
) | ||
|
|
|
|
|
|
| ||
|
Cash flows from investing activities: |
|
|
|
|
| ||
|
Purchases of property and equipment |
|
(40 |
) |
(89 |
) | ||
|
Proceeds from sale of investments available for sale |
|
11,555 |
|
17,098 |
| ||
|
Purchases of investments available for sale |
|
(5 |
) |
(209 |
) | ||
|
|
|
|
|
|
| ||
|
Net cash provided by investing activities |
|
11,510 |
|
16,800 |
| ||
|
|
|
|
|
|
| ||
|
Cash flows from financing activities: |
|
|
|
|
| ||
|
Principal payments on capital lease obligations |
|
— |
|
(3 |
) | ||
|
Proceeds from the exercise of stock options |
|
1 |
|
1 |
| ||
|
|
|
|
|
|
| ||
|
Net cash provided by (used in) financing activities |
|
1 |
|
(2 |
) | ||
|
|
|
|
|
|
| ||
|
Net increase in cash |
|
68 |
|
178 |
| ||
|
Cash at beginning of period |
|
1,442 |
|
1,306 |
| ||
|
|
|
|
|
|
| ||
|
Cash at end of period |
|
$ |
1,510 |
|
$ |
1,484 |
|