Osiris Therapeutics Reports Second Quarter 2008 Financial Results Thursday, August 07, 2008 8:05 AM
Symbols: OSIR
Osiris Therapeutics, Inc. (NASDAQ:OSIR), the leader in stem cell
therapeutics, announced today its results for the second quarter of 2008.
Second Quarter Highlights and Recent Developments
-
Completed the technology assets closing under the asset purchase
agreement with NuVasive, Inc. for the sale of the Osteocel business in
a transaction worth up to $137 million.
-
Received $2 million in milestone payments from the Juvenile Diabetes
Research Foundation (JDRF) for progress made on a Phase II clinical
trial evaluating Prochymal for patients recently diagnosed with type 1
diabetes.
-
Initiated a Phase II clinical trial evaluating Prochymal for chronic
obstructive pulmonary disease (COPD).
-
Received U.S. Food and Drug Administration (FDA) clearance to initiate
an expanded access treatment program for Prochymal, making the
investigational stem cell product available to children with
life-threatening graft vs. host disease (GvHD).
-
Strengthened management team with the appointment of Richard W. Hunt
as Chief Financial Officer.
“We continue to make rapid progress on the
development of our lead product Prochymal and are now preparing for
commercial launch of what we believe will be the world’s
first stem cell drug,” said C. Randal Mills,
Ph.D., President and Chief Executive Officer of Osiris Therapeutics. “In
addition, we continue to strengthen the financial underpinnings of the
company by closing and performing under our Osteocel transaction. We
look forward to continued progress in what should be an exciting
remainder of the year.”
Second Quarter Financial Results
On July 24, 2008, following shareholder approval, the technology assets
closing occurred under the asset purchase agreement entered into with
NuVasive, Inc. for the sale of the Osteocel business and the initial
payment of $35 million was received. The transaction is comprised of two
significant components. The first is the sale of the Osteocel business
and related assets pursuant to the asset purchase agreement in
consideration for up to $85 million, including the $35 million initial
payment and up to $50 million in milestone payments. The second is a
manufacturing agreement for the manufacture and sale by Osiris to
NuVasive of Osteocel for a period of approximately 18 months, under
which Osiris will have the opportunity to earn approximately $52 million
in revenue from discontinued operations.
For the second quarter of 2008, Osteocel sales were $9.0 million,
compared to $3.3 million for the same period of the prior year. Osiris
intends to use the proceeds from the sale of its Osteocel business to
fund its core business, focused on the development and commercialization
of stem cell therapeutics.
During the second quarter of 2008, Osiris achieved the first two
milestones of its collaborative agreement with JDRF and recognized
revenue of $2.0 million. Osiris also recognized $0.5 million in revenue
on its preclinical development work evaluating Prochymal to treat acute
radiation syndrome under its contract with the U.S. Department of
Defense and $0.1 million in royalties.
Osiris reported a net loss of $15.4 million for the second quarter of
2008 compared to a net loss of $10.5 million in the second quarter of
the prior year. The increase in the 2008 first quarter loss was largely
the result of the continued advancement of clinical trials, costs
associated with the production of increased amounts of Prochymal for use
in clinical trials, and work on the Company’s
biologic license application with the FDA as the Company approaches the
commercialization of Prochymal. Osiris reported a loss from continuing
operations of $18.5 million for the second quarter of 2008 compared to a
loss from continuing operations of $12.1 million for the same period of
the prior year. During the quarter, net cash used in continuing
operations was $11.6 million compared to $12.9 million in the prior year.
Research and development expenses were $19.0 million for the second
quarter of 2008 compared to $10.4 million for the same period of the
prior year. General and administrative (G&A) expenses were $1.8 million
for the second quarter of 2008 compared to $1.5 million for the same
period of the prior year. During the second quarter of 2008, research
and development expenses represented 91% of total operating expenses.
Webcast and Conference Call
The Company has scheduled a webcast and conference call to discuss its
financial results today, August 7, 2008, at 9:00 AM EDT. 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) 681-3373 (U.S. participants) or (719) 325-4877 (international
participants).
A replay of the conference call will be available approximately two
hours after the completion of the call through August 21, 2008. Callers
can access the replay by dialing (888) 203-1112 (U.S. participants) or
(719) 457-0820 (international participants). The audio replay passcode
is 1544354. 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 a leading stem cell therapeutic company
focused on developing products to treat medical conditions in the
inflammatory, orthopedic and cardiovascular areas. Prochymal is being
evaluated in Phase III clinical trials for three indications, including
acute and steroid refractory Graft versus Host Disease and also Crohn's
disease, and is the only stem cell therapeutic currently designated by
FDA as both an Orphan Drug and Fast Track product. Osiris also has
partnered with Genzyme Corporation to develop Prochymal as a medical
countermeasure to nuclear terrorism and other radiological emergencies.
Furthermore, Prochymal is being developed for the repair of heart tissue
following a heart attack, the protection of pancreatic islet cells in
patients with type 1 diabetes, and the repair of lung tissue in patients
with chronic obstructive pulmonary disease. The Company’s
pipeline of internally developed biologic drug candidates under
evaluation also includes Chondrogen for arthritis in the knee. Osiris is
a fully integrated company, having developed 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. patents each having
one or more foreign counterparts. Osiris, Prochymal and Chondrogen 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; 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 MSCs and biologic drug candidates; our cash needs;
patents and proprietary rights; ability of our potential products to
treat disease; 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. 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 Quarterly 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
|
|
(Unaudited)
|
|
Amounts in thousands
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008
|
|
|
December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
2,353
|
|
|
$
|
704
|
|
|
Investments available for sale
|
|
4,662
|
|
|
17,460
|
|
|
Accounts receivable
|
|
1,544
|
|
|
549
|
|
|
Prepaid expenses and other current assets
|
|
2,097
|
|
|
1,583
|
|
|
Current assets of discontinued operations
|
|
10,675
|
|
|
8,445
|
|
|
Total current assets
|
|
21,331
|
|
|
28,741
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
1,032
|
|
|
2,020
|
|
|
Restricted cash
|
|
280
|
|
|
280
|
|
|
Other assets
|
|
825
|
|
|
1,404
|
|
|
Long-term assets of discontinued operations
|
|
8,172
|
|
|
4,596
|
|
|
Total assets
|
|
$
|
31,640
|
|
|
$
|
37,041
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT)
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
21,271
|
|
|
$
|
11,535
|
|
|
Notes payable, current portion
|
|
18,391
|
|
|
6,521
|
|
|
Capital lease obligations, current portion
|
|
283
|
|
|
886
|
|
|
Current liabilities of discontinued operations
|
|
3,974
|
|
|
2,552
|
|
|
Total current liabilities
|
|
43,919
|
|
|
21,494
|
|
|
|
|
|
|
|
|
|
|
Note payable, net of current portion
|
|
2,500
|
|
|
1,200
|
|
|
Other long-term liabilities
|
|
16
|
|
|
11
|
|
|
Total liabilities
|
|
46,435
|
|
|
22,705
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity (deficit):
|
|
|
|
|
|
|
|
Common stock, $.001 par value, 90,000 shares authorized 31,771 and
31,648 shares outstanding in 2008 and 2007
|
|
32
|
|
|
32
|
|
|
Additional paid-in-capital
|
|
258,197
|
|
|
255,728
|
|
|
Accumulated other comprehensive loss
|
|
(632
|
)
|
|
―
|
|
|
Accumulated deficit
|
|
(272,392
|
)
|
|
(241,424
|
)
|
|
Total stockholders’ equity (deficit)
|
|
(14,795
|
)
|
|
14,336
|
|
|
Total liabilities and stockholders’
equity (deficit)
|
|
$
|
31,640
|
|
|
$
|
37,041
|
|
|
OSIRIS THERAPEUTICS, INC.
|
|
Condensed Statements of Operations
|
|
(Unaudited)
|
|
Amounts in thousands, except per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
|
Six Months Ended June 30,
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from government contracts, collaborative research agreements
and royalties
|
|
$
|
2,530
|
|
|
$
|
295
|
|
|
$
|
2,892
|
|
|
$
|
574
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
19,048
|
|
|
10,440
|
|
|
35,742
|
|
|
18,934
|
|
|
General and administrative
|
|
1,782
|
|
|
1,501
|
|
|
4,390
|
|
|
3,007
|
|
|
Total operating expenses
|
|
20,830
|
|
|
11,941
|
|
|
40,132
|
|
|
21,941
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
(18,300
|
)
|
|
(11,646
|
)
|
|
(37,240
|
)
|
|
(21,367
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
(172
|
)
|
|
(418
|
)
|
|
(381
|
)
|
|
(761
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
(18,472
|
)
|
|
(12,064
|
)
|
|
(37,621
|
)
|
|
(22,128
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income from operations of discontinued operations
|
|
3,104
|
|
|
1,606
|
|
|
6,653
|
|
|
169
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(15,368
|
)
|
|
$
|
(10,458
|
)
|
|
$
|
(30,968
|
)
|
|
$
|
(21,959
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(0.58
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(1.19
|
)
|
|
$
|
(0.80
|
)
|
|
Income from discontinued operations
|
|
0.10
|
|
|
0.06
|
|
|
0.21
|
|
|
0.01
|
|
|
Net loss
|
|
$
|
(0.48
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(0.98
|
)
|
|
$
|
(0.79
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares (basic and diluted)
|
|
31,769
|
|
|
27,914
|
|
|
31,754
|
|
|
27,649
|
|
|
OSIRIS THERAPEUTICS, INC.
|
|
Condensed Statements of Cash Flows
|
|
(Unaudited)
|
|
Amounts in thousands
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
Continuing Operations:
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$
|
(37,621
|
)
|
|
$
|
(22,128
|
)
|
|
Adjustments to reconcile loss from continuing operations
to net cash used in continuing operations:
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
940
|
|
|
821
|
|
|
Non cash share-based payments
|
|
887
|
|
|
827
|
|
|
Non cash interest expense
|
|
130
|
|
|
120
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable
|
|
(995
|
)
|
|
75
|
|
|
Prepaid expenses and other current assets
|
|
(513
|
)
|
|
(107
|
)
|
|
Other assets
|
|
560
|
|
|
328
|
|
|
Accounts payable and accrued expenses
|
|
9,736
|
|
|
(2,334
|
)
|
|
Deferred revenue
|
|
—
|
|
|
(476
|
)
|
|
Long-term interest payable and other liabilities
|
|
9
|
|
|
200
|
|
|
Net cash used in continuing operations
|
|
(26,867
|
)
|
|
(22,674
|
)
|
|
Discontinued Operations:
|
|
|
|
|
|
|
|
|
|
Income from discontinued operations
|
|
|
6,653
|
|
|
|
169
|
|
|
Adjustments to reconcile income to net cash provided by (used in)
discontinued operations:
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
149
|
|
|
52
|
|
|
Non cash share-based payments
|
|
78
|
|
|
22
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
Accounts receivable
|
|
(1,684
|
)
|
|
(561
|
)
|
|
Inventory and other current assets
|
|
(546
|
)
|
|
(95
|
)
|
|
Accounts payable and accrued expenses
|
|
1,422
|
|
|
204
|
|
|
Net cash provided by (used in) discontinued operations
|
|
6,072
|
|
|
(209
|
)
|
|
Net cash used by operating activities
|
|
(20,795
|
)
|
|
(22,883
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
(3,676
|
)
|
|
| |