Attached files
| file | filename |
|---|---|
| 8-K - 8-K - OSIRIS THERAPEUTICS, INC. | a15-17019_18k.htm |
Exhibit 99.1
Osiris Therapeutics Announces Second Quarter 2015 Financial Results
COLUMBIA, Md. —August 5, 2015 - Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading cellular regenerative medicine company focused on developing and marketing products to treat conditions in wound care, orthopaedics and sports medicine, announced today its financial results for the second quarter of 2015.
Second Quarter Highlights and Developments
· Increased product revenue for the quarter to $23.7 million - a 78% increase over Q2 2014 and a 13% increase over previous quarter.
· Increased coverage for Grafix® to 123 million lives, an increase of 25 million lives compared to the previous quarter.
· Published seven peer reviewed manuscripts, including data on a prospective study of Grafix in chronic venous ulcers.
· Initiated preparations for a Phase III confirmatory study in venous ulcers with the goal to prepare a supplemental BLA for that indication.
· Invested further in the expansion of the commercial infrastructure, including the addition of sales and marketing professionals and establishment of an internal hotline and insurance verification department.
· Completed the quarter with after-tax income from operations of $1.2 million or $0.03 per share and with $103 million in total assets.
“We remain laser focused on growing revenue and investing in our leading brands,” said Lode Debrabandere, Ph.D., President and Chief Executive Officer. “Despite the expiration of pass-through status for Grafix in early January, the wound care business continues to grow revenue by double-digits. The team has made tremendous progress in opening more accounts and increasing the number of patients treated with Grafix.”
Second Quarter Financial Results
Product revenues during the second quarter of 2015 were $23.7 million, compared to $13.3 million during the second quarter of 2014, an increase of 78%. Gross margin during the second quarter remained the same as the second quarter of 2014 at 78%. Gross profit was $18.5 million during the second quarter of 2015 and $10.4 million during the same period of 2014. The net income from continuing operations was $1.2 million in the second quarter of 2015 after recognizing income taxes of $0.4 million. As of June 30, 2015, Osiris had $103 million of total assets.
Research and development expenses for the second quarter of 2015 were $2.3 million, increased from the $1.1 million incurred in the second quarter of 2014. As a result of our increased commercial activity, our selling, general and administrative expenses were $14.5 million for the second quarter of 2015, compared to $9.4 million for the same period of the prior year.
Conference Call
A webcast and conference call to discuss the financial results is scheduled for today, August 5, 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).
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., based in Columbia, Maryland, is the world leader in researching, developing and marketing regenerative medicine products that improve health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, the company continues to advance its research and development in biotechnology by focusing on innovation in regenerative medicine — including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO4 ™, Cartiform® and Grafix.
Osiris, Grafix and Cartiform are registered trademarks of Osiris Therapeutics, Inc. BIO4 is a trademark of Stryker Corporation (NYSE: SYK). 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 product and product 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 marketed Biosurgery products (including Grafix, BIO4 and Cartiform) and Biosurgery products under development; our cash needs; patents, trademarks and other proprietary rights; the safety and ability of our products and potential products to address medical needs; our ability to supply a sufficient amount of our marketed products or product candidates and, if approved or otherwise commercially available, future products, to meet demand; our ability to commercialize and distribute our current and any future marketed products, including our ability and the ability of end users to obtain reimbursement from Medicare and other third party payors; our relationships with collaborating partners; our ability to maintain and benefit from our collaborative arrangements; 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. Additional risks and uncertainties related to the prior sale of our ceMSC assets to Mesoblast include typical business transactional risks, the risk of changing relationships with customers, suppliers or employees, the risk associated with the disposition of our ceMSC assets and the increased relative dependence on and importance of our other business including our Biosurgery business, the risk that we may not be able to fully benefit from the transaction through milestone payments or royalties, payment risks, including the risk associated with receipt of equity as consideration, in lieu of cash, and the risk of dependence on others to achieve results upon which milestone or royalty payments to us are conditioned. In addition to all of the risks otherwise applicable to us and our business, there are numerous risks and uncertainties related to our collaborative relationships. For example, in the case of our Exclusive Service
Agreement with Stryker for the commercialization of BIO4 these risks include, among others, typical business transactional risks, Stryker’s early termination rights, the ability of Stryker to successfully market and promote BIO4, the ability of Osiris to successfully fulfill its supply obligations, and the risk of dependence on others to generate sales of allograft services for BIO4. 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:
Amanda Badillo
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com
OSIRIS THERAPEUTICS, INC.
Condensed Balance Sheets
(amounts in thousands, except per share data)
|
|
|
June 30, 2015 |
|
December 31, 2014 |
| ||
|
|
|
(Unaudited) |
|
|
| ||
|
Assets |
|
|
|
|
| ||
|
Current assets: |
|
|
|
|
| ||
|
Cash |
|
$ |
1,563 |
|
$ |
2,208 |
|
|
Investments available for sale |
|
37,083 |
|
37,305 |
| ||
|
Trading securities |
|
8,300 |
|
10,591 |
| ||
|
Trade accounts receivable, net of reserves |
|
38,598 |
|
24,307 |
| ||
|
Other receivables |
|
720 |
|
9,951 |
| ||
|
Inventory |
|
13,348 |
|
10,924 |
| ||
|
Prepaids and other current assets |
|
1,223 |
|
650 |
| ||
|
Total current assets |
|
100,835 |
|
95,936 |
| ||
|
|
|
|
|
|
| ||
|
Property and equipment, net |
|
2,077 |
|
2,087 |
| ||
|
Other assets |
|
95 |
|
95 |
| ||
|
|
|
|
|
|
| ||
|
Total assets |
|
$ |
103,007 |
|
$ |
98,118 |
|
|
|
|
|
|
|
| ||
|
Liabilities and Stockholders’ Equity |
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Current liabilities: |
|
|
|
|
| ||
|
Accounts payable and accrued expenses |
|
$ |
9,217 |
|
$ |
8,854 |
|
|
Capital lease obligations, current portion |
|
45 |
|
45 |
| ||
|
Deferred commissions payable, current portion |
|
1,667 |
|
1,667 |
| ||
|
Total current liabilities |
|
10,929 |
|
10,566 |
| ||
|
|
|
|
|
|
| ||
|
Other long-term liabilities |
|
3,256 |
|
3,589 |
| ||
|
Total liabilities |
|
14,185 |
|
14,155 |
| ||
|
|
|
|
|
|
| ||
|
Commitments and contingencies |
|
|
|
|
| ||
|
|
|
|
|
|
| ||
|
Stockholders’ equity |
|
|
|
|
| ||
|
Common stock, $.001 par value, 90,000 shares authorized, 34,439 shares outstanding - 2015, 34,346 shares outstanding - 2014 |
|
35 |
|
35 |
| ||
|
Additional paid-in-capital |
|
289,991 |
|
287,525 |
| ||
|
Accumulated other comprehensive loss |
|
(202 |
) |
(54 |
) | ||
|
Accumulated deficit |
|
(201,002 |
) |
(203,543 |
) | ||
|
Total stockholders’ equity |
|
88,822 |
|
83,963 |
| ||
|
|
|
|
|
|
| ||
|
Total liabilities and stockholders’ equity |
|
$ |
103,007 |
|
$ |
98,118 |
|
OSIRIS THERAPEUTICS, INC.
Condensed Statements of Comprehensive Income (Loss)
Unaudited
(amounts in thousands, except per share data)
|
|
|
Three Months Ended |
|
Six Months Ended |
| ||||||||
|
|
|
June 30, |
|
June 30, |
| ||||||||
|
|
|
2015 |
|
2014 |
|
2015 |
|
2014 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Product revenues |
|
$ |
23,688 |
|
$ |
13,290 |
|
$ |
44,691 |
|
$ |
23,344 |
|
|
Cost of product revenues |
|
5,142 |
|
2,924 |
|
9,751 |
|
5,136 |
| ||||
|
Gross profit |
|
18,546 |
|
10,366 |
|
34,940 |
|
18,208 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Operating expenses: |
|
|
|
|
|
|
|
|
| ||||
|
Research and development |
|
2,287 |
|
1,055 |
|
3,927 |
|
1,725 |
| ||||
|
Selling, general and administrative |
|
14,526 |
|
9,377 |
|
27,437 |
|
17,164 |
| ||||
|
|
|
16,813 |
|
10,432 |
|
31,364 |
|
18,889 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income (loss) from operations of continuing operations |
|
1,733 |
|
(66 |
) |
3,576 |
|
(681 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Other income (expense), net |
|
(202 |
) |
(1,232 |
) |
(56 |
) |
(1,358 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income (loss) from continuing operations, before income taxes |
|
1,531 |
|
(1,298 |
) |
3,520 |
|
(2,039 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income tax expense |
|
(367 |
) |
(130 |
) |
(979 |
) |
— |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Income (loss) from continuing operations |
|
1,164 |
|
(1,428 |
) |
2,541 |
|
(2,039 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Discontinued operations: |
|
|
|
|
|
|
|
|
| ||||
|
Loss from operations of discontinued operations, net of income taxes of $431 and $597, for the three months and six months ended June 30, 2014, respectively |
|
— |
|
(457 |
) |
— |
|
(1,211 |
) | ||||
|
Loss from discontinued operations |
|
— |
|
(457 |
) |
— |
|
(1,211 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Net income (loss) |
|
1,164 |
|
(1,885 |
) |
2,541 |
|
(3,250 |
) | ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Other comprehensive income (loss) |
|
|
|
|
|
|
|
|
| ||||
|
Unrealized (loss) gain on investments available for sale |
|
(58 |
) |
17 |
|
(148 |
) |
105 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Comprehensive income (loss) |
|
$ |
1,106 |
|
$ |
(1,868 |
) |
$ |
2,393 |
|
$ |
(3,145 |
) |
|
|
|
|
|
|
|
|
|
|
| ||||
|
Basic income (loss) per share |
|
|
|
|
|
|
|
|
| ||||
|
Income (loss) from continuing operations |
|
$ |
0.03 |
|
$ |
(0.04 |
) |
$ |
0.07 |
|
$ |
(0.06 |
) |
|
Loss from discontinued operations |
|
— |
|
(0.01 |
) |
— |
|
(0.04 |
) | ||||
|
Basic income (loss) per share |
|
$ |
0.03 |
|
$ |
(0.05 |
) |
$ |
0.07 |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
| ||||
|
Diluted income (loss) per share |
|
|
|
|
|
|
|
|
| ||||
|
Income (loss) from continuing operations |
|
$ |
0.03 |
|
$ |
(0.04 |
) |
$ |
0.07 |
|
$ |
(0.06 |
) |
|
Loss from discontinued operations |
|
— |
|
(0.01 |
) |
— |
|
(0.04 |
) | ||||
|
Diluted income (loss) per share |
|
$ |
0.03 |
|
$ |
(0.05 |
) |
$ |
0.07 |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
|
| ||||
|
Weighted average common shares (basic) |
|
34,411 |
|
34,264 |
|
34,384 |
|
34,207 |
| ||||
|
|
|
|
|
|
|
|
|
|
| ||||
|
Weighted average common shares (diluted) |
|
34,890 |
|
34,264 |
|
34,858 |
|
34,207 |
| ||||
OSIRIS THERAPEUTICS, INC.
Condensed Statements of Cash Flows
Unaudited
(amounts in thousands)
|
|
|
Six Months ended June 30, |
| ||||
|
|
|
2015 |
|
2014 |
| ||
|
Cash flows from operating activities: |
|
|
|
|
| ||
|
Continuing operations |
|
|
|
|
| ||
|
Income (loss) from continuing operations |
|
$ |
2,541 |
|
$ |
(2,039 |
) |
|
Adjustments to reconcile income (loss) from continuing operations to net cash used in operations of continuing operations: |
|
|
|
|
| ||
|
Net realized and unrealized loss on trading securities |
|
259 |
|
1,502 |
| ||
|
Realized loss (gain) on investments available for sale |
|
91 |
|
(168 |
) | ||
|
Depreciation and amortization |
|
547 |
|
441 |
| ||
|
Non cash share-based payments |
|
1,631 |
|
1,537 |
| ||
|
Provision for bad debts |
|
— |
|
50 |
| ||
|
Guaranteed payment related to trading securities |
|
6,198 |
|
— |
| ||
|
Changes in operating assets and liabilities: |
|
|
|
|
| ||
|
Accounts receivable |
|
(14,291 |
) |
(9,481 |
) | ||
|
Inventory |
|
(2,424 |
) |
(3,611 |
) | ||
|
Other receivables |
|
5,065 |
|
(208 |
) | ||
|
Prepaid expenses and other current assets |
|
(573 |
) |
— |
| ||
|
Lease reserves |
|
— |
|
(53 |
) | ||
|
Accounts payable, accrued expenses, and other liabilities |
|
52 |
|
3,195 |
| ||
|
Net cash used in operating activities of continuing operations |
|
(904 |
) |
(8,835 |
) | ||
|
Discontinued operations |
|
|
|
|
| ||
|
Loss from discontinued operations |
|
— |
|
(1,211 |
) | ||
|
Adjustments to reconcile loss from discontinued operations to net cash used in operations of discontinued operations: |
|
|
|
|
| ||
|
Changes in operating assets and liabilities: |
|
|
|
|
| ||
|
Accounts receivable and other current assets |
|
— |
|
91 |
| ||
|
Accounts payable and accrued expenses |
|
— |
|
(57 |
) | ||
|
Net cash used in operations of discontinued operations |
|
— |
|
(1,177 |
) | ||
|
|
|
|
|
|
| ||
|
Net cash used in operating activities |
|
(904 |
) |
(10,012 |
) | ||
|
|
|
|
|
|
| ||
|
Cash flows from investing activities: |
|
|
|
|
| ||
|
Purchases of property and equipment |
|
(537 |
) |
(440 |
) | ||
|
Proceeds from sale of discontinued operations, net |
|
— |
|
15,000 |
| ||
|
Proceeds from sale of investments available for sale |
|
52,902 |
|
8,307 |
| ||
|
Purchases of investments available for sale |
|
(52,919 |
) |
(14,117 |
) | ||
|
Net cash (used in) provided by investing activities |
|
(554 |
) |
8,750 |
| ||
|
|
|
|
|
|
| ||
|
Cash flows from financing activities: |
|
|
|
|
| ||
|
Principal payments on capital lease obligations |
|
(22 |
) |
(22 |
) | ||
|
Restricted cash |
|
— |
|
20 |
| ||
|
Proceeds from the exercise of options to purchase common stock |
|
716 |
|
1,417 |
| ||
|
Windfall tax benefit from stock-based compensation |
|
119 |
|
89 |
| ||
|
Net cash provided by financing activities |
|
813 |
|
1,504 |
| ||
|
|
|
|
|
|
| ||
|
Net (decrease) increase in cash |
|
(645 |
) |
242 |
| ||
|
Cash at beginning of period |
|
2,208 |
|
2,416 |
| ||
|
|
|
|
|
|
| ||
|
Cash at end of period |
|
$ |
1,563 |
|
$ |
2,658 |
|
|
|
|
|
|
|
| ||
|
Supplemental disclosure of cash flows information: |
|
|
|
|
| ||
|
Cash paid for income taxes |
|
$ |
1,994 |
|
$ |
— |
|
|
Supplemental disclosure of non cash activities: |
|
|
|
|
| ||
|
Receivable due from sale of trading securities |
|
243 |
|
— |
| ||