x
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QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF
1934
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For
the quarterly period ended
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September
30, 2008
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¨
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TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
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ORTHOLOGIC
CORP.
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(Exact
name of registrant as specified in its
charter)
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Delaware
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86-0585310
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(State
or other jurisdiction of incorporation or organization)
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(IRS
Employer Identification No.)
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1275
W. Washington Street, Tempe, Arizona
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85281
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(Address
of principal executive offices)
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(Zip
Code)
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(602)
286-5520
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(Registrant's
telephone number, including area
code)
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(Former
name, former address and former fiscal year, if changed since last
report)
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Large accelerated
filer ¨
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Accelerated
filer x
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Non-accelerated
filer ¨
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Smaller
reporting company ¨
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Page
No.
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|||||
Part
I
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Financial
Information
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||||
Item 1. | Financial Statements (Unaudited) | ||||
3
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|||||
4
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|||||
5
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|||||
6
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Item
2.
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10
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||||
Item
4.
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13
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||||
Part
II
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Other
Information
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||||
Item
1A.
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13
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||||
Item
2.
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15
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||||
Item 5. | Other Information |
15
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Item
6.
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15
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||||
EXHIBIT
10.1
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|||||
EXHIBIT
10.2
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|||||
EXHIBIT
31.1
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|||||
EXHIBIT
31.2
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|||||
EXHIBIT
32
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Item
1.
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Financial
Statements
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September 30,
2008
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December 31,
2007
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|||||||
(Unaudited)
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||||||||
ASSETS
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||||||||
Current
assets
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||||||||
Cash
and cash equivalents
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$ | 7,162 | $ | 20,943 | ||||
Short-term
investments
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39,322 | 18,236 | ||||||
Prepaids
and other current assets
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1,142 | 906 | ||||||
Total
current assets
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47,626 | 40,085 | ||||||
Furniture
and equipment, net
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366 | 318 | ||||||
Long-term
investments
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4,508 | 21,459 | ||||||
Total
assets
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$ | 52,500 | $ | 61,862 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
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||||||||
Current
liabilities
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||||||||
Accounts
payable
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$ | 905 | $ | 702 | ||||
Accrued
compensation
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839 | 824 | ||||||
Other
accrued liabilities
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629 | 875 | ||||||
Total
current liabilities
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2,373 | 2,401 | ||||||
Stockholders'
Equity
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||||||||
Common
Stock $.0005 par value; 100,000,000 shares authorized;
40,731,642 in 2008 and 41,758,065 in 2007 shares issued and
outstanding
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20 | 21 | ||||||
Additional
paid-in capital
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188,244 | 189,013 | ||||||
Accumulated
deficit
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(138,137 | ) | (129,573 | ) | ||||
Total
stockholders' equity
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50,127 | 59,461 | ||||||
Total
liabilities and stockholders' equity
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$ | 52,500 | $ | 61,862 |
Three
months ended September 30,
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Nine
months ended September 30,
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As a Development
Stage Company
August 5, 2004 -
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||||||||||||||||||
2008
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2007
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2008
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2007
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September 30, 2008
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||||||||||||||||
OPERATING
EXPENSES
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||||||||||||||||||||
General
and administrative
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$ | 815 | $ | 889 | $ | 2,378 | $ | 2,797 | $ | 19,462 | ||||||||||
Research
and development
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2,817 | 2,369 | 7,845 | 7,439 | 70,671 | |||||||||||||||
Purchased
in-process research and development
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- | - | - | - | 34,311 | |||||||||||||||
Other
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- | - | - | - | (375 | ) | ||||||||||||||
Total
operating expenses
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3,632 | 3,258 | 10,223 | 10,236 | 124,069 | |||||||||||||||
Interest
and other income, net
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(488 | ) | (833 | ) | (1,659 | ) | (2,558 | ) | (12,211 | ) | ||||||||||
Loss
from continuing operations
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3,144 | 2,425 | 8,564 | 7,678 | 111,858 | |||||||||||||||
Income
tax expense
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- | - | - | - | 356 | |||||||||||||||
Loss
from continuing operations
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3,144 | 2,425 | 8,564 | 7,678 | 112,214 | |||||||||||||||
Discontinued
operations - net gain on sale of the bone device business, net of taxes
($267)
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- | - | - | - | (2,202 | ) | ||||||||||||||
NET
LOSS
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$ | 3,144 | $ | 2,425 | $ | 8,564 | $ | 7,678 | $ | 110,012 | ||||||||||
Per
Share Information:
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||||||||||||||||||||
Net
loss, basic and diluted
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$ | 0.08 | $ | 0.06 | $ | 0.21 | $ | 0.18 | ||||||||||||
Basic
and diluted shares outstanding
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40,775 | 41,671 | 41,200 | 41,634 |
Nine
months ended September 30,
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As a Development
Stage Company
August 5th 2004
-
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|||||||||||
2008
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2007
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September 30, 2008
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||||||||||
OPERATING
ACTIVITIES
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||||||||||||
Net
loss
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$ | (8,564 | ) | $ | (7,678 | ) | $ | (110,012 | ) | |||
Non
cash items:
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||||||||||||
Deferred
tax expense
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- | - | 770 | |||||||||
Depreciation
and amortization
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99 | 107 | 3,533 | |||||||||
Non-cash
stock compensation
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246 | 591 | 3,966 | |||||||||
Gain
on sale of bone device business
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- | - | (2,298 | ) | ||||||||
In-process
research and development
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- | - | 34,311 | |||||||||
Change
in other operating items:
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||||||||||||
Prepaids
and other current assets
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(237 | ) | 1,048 | 566 | ||||||||
Accounts
payable
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203 | (1,013 | ) | (66 | ) | |||||||
Accrued
liabilities
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(229 | ) | (486 | ) | (1,546 | ) | ||||||
Cash
flows used in operating activities
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(8,482 | ) | (7,431 | ) | (70,776 | ) | ||||||
INVESTING
ACTIVITIES
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||||||||||||
Expenditures
for furniture and equipment, net
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(148 | ) | (158 | ) | (841 | ) | ||||||
Proceeds
from sale of assets
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- | - | 7,000 | |||||||||
Cash
paid for assets of AzERx/CBI
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- | - | (4,058 | ) | ||||||||
Cash
paid for patent assignment rights
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- | - | (650 | ) | ||||||||
Purchases
of investments
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(28,845 | ) | (33,077 | ) | (226,134 | ) | ||||||
Maturities
of investments
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24,711 | 40,802 | 240,243 | |||||||||
Cash
flows (used in) provided by investing activities
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(4,282 | ) | 7,567 | 15,560 | ||||||||
FINANCING
ACTIVITIES
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||||||||||||
Net
proceeds from stock option exercises
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- | - | 4,612 | |||||||||
Net
proceeds from sale of stock
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- | - | 3,376 | |||||||||
Common
stock purchases
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(1,017 | ) | - | (1,017 | ) | |||||||
Cash
flows (used in) provided by financing activities
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(1,017 | ) | - | 6,971 | ||||||||
NET
(DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS
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(13,781 | ) | 136 | (48,245 | ) | |||||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
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20,943 | $ | 18,047 | 55,407 | ||||||||
CASH
AND CASH EQUIVALENTS, END OF PERIOD
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$ | 7,162 | $ | 18,183 | $ | 7,162 |
Supplemental
Disclosure of Non-Cash Investing Activities
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AzERx
and CBI
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|||
AzERx/CBI
Acquisitions
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||||
Current
assets acquired
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$ | 29 | ||
Patents
acquired
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2,142 | |||
Liabilities
acquired, and accrued acquisition costs
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(457 | ) | ||
Original
investment reversal
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(750 | ) | ||
In-process
research and development acquired
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34,311 | |||
Common
stock issued for acquisition
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(31,217 | ) | ||
Cash
paid for acquisition
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$ | 4,058 |
Three
months ended
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March
31, 2008
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Risk
free interest rate
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2.4% - 3.4%
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Volatility
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57% - 58%
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Expected
term from vesting
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3.7
Years
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Dividend
yield
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0%
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Management’s
Discussion and Analysis of Financial Condition and Results of
Operations.
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·
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Evaluating
AZX100 for medically and commercially significant applications, such as
prevention of dermal scarring, pulmonary fibrosis, the treatment of
asthma, and vascular intimal hyperplasia. We performed
pre-clinical work leading to the filing of an IND for a dermal indication
in 2007 and commenced a Phase 1a safety study in dermal scarring in the
first quarter of 2008. Our Phase 1a study included 30 subjects
and was completed in May 2008. The study’s Safety Committee
reviewing all safety-related aspects of the clinical trial was satisfied
with the profile of AZX100. On this basis, we have initiated a
second safety study for dermal scarring (Phase 1b), which included 40
subjects and is planned to be completed in the fourth quarter of
2008. Subject to the findings of the Phase 1b study’s Safety
Committee, the Company is preparing to initiate Phase 2 human clinical
efficacy studies of AZX100 in dermal scarring in the first quarter of
2009. We continue to perform further pre-clinical studies
supporting multiple indications for
AZX100.
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·
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Pre-clinical
experiments examining the potential for Chrysalin in modulating of the
health of endothelial tissue in blood vessels. These and other
mechanism-of-action studies will support our strategy to partner Chrysalin
in vascular applications. We did not perform additional pre-clinical or
clinical studies in fracture repair, wound healing, spine fusion,
cartilage defect repair, dental bone repair or tendon
repair. In 2008, we are continuing studies to support our
vascular partnering efforts.
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Controls
and Procedures
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·
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unfavorable
results of our product candidate development
efforts;
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·
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unfavorable
results of our pre-clinical or clinical
testing;
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·
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delays
in obtaining, or failure to obtain FDA
approvals;
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·
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increased
regulation by the FDA and other
agencies;
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·
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the
introduction of competitive
products;
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·
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impairment
of license, patent or other proprietary
rights;
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·
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failure
to achieve market acceptance of our
products;
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|
·
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the
impact of present and future collaborative
agreements;
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·
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failure
to successfully implement our drug development strategy,
and
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·
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failure
in the future to meet the requirements for continued listing on the NASDAQ
Markets.
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·
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announcement
of the results of, or delays in, preclinical and clinical
studies;
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·
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fluctuations
in our operating results;
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·
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developments
in litigation to which we or a competitor is
subject;
|
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·
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announcements
and timing of potential acquisitions, divestitures, capital raising
activities or issuance of preferred
stock;
|
|
·
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announcements
of technological innovations or new products by us or our
competitors;
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·
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FDA
and other regulatory actions;
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·
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developments
with respect to our or our competitors’ patents or proprietary
rights;
|
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·
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public
concern as to the safety of products developed by us or
others;
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·
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changes
in stock market analyst recommendations regarding us, other drug
development companies or the pharmaceutical industry generally;
and
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·
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if
we are unable in the future to meet the requirements for continued listing
on the NASDAQ Markets.
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Item 2.
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Unregistered
Sales of Equity Securities and Use of
Proceeds
|
Month
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Total
Number of shares purchased
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Average
price paid per share
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Total
number of shares purchased as part of publicly announced
program
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Maximum
number of shares that may yet be purchased under the
program
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||||||||||||
July
1 - 31, 2008
|
173,775 | $ | 0.85 | 173,775 | ||||||||||||
August
1 - 31, 2008
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18,000 | $ | 0.77 | 18,000 | 1,005,000 |
Item
6.
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Exhibits
|
Signature
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Title
|
Date
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/s/ John M. Holliman,
III
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Executive
Chairman
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November
6, 2008
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John
M. Holliman, III
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(Principal
Executive Officer)
|
|
/s/ Les M. Taeger
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Senior
Vice-President and Chief
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November
6, 2008
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Les
M. Taeger
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Financial
Officer
|
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(Principal
Financial and Accounting Officer)
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Exhibit
No.
|
Description
|
Incorporated by Reference
to:
|
Filed
Herewith
|
Amendment
No. 3, dated November 4, 2008, to the Management Services Agreement
effective May 12, 2006 by and between AGP Management, LP, John M.
Holliman, III, Executive Chairman, and OrthoLogic Corp.
(1)
|
X
|
||
Amendment
No. 3, dated November 4, 2008, to the Employment Agreement effective May
12, 2006, between Randolph C. Steer, MD, Ph.D., President, and OrthoLogic
Corp. (1)
|
X
|
||
Certification
of Principal Executive Officer Pursuant to Rule 13a -14(a) of
the Securities Exchange Act of 1934, as amended
|
X
|
||
Certification
of Principal Financial and Accounting Officer Pursuant to Rule
13a -14(a) of the Securities Exchange Act of 1934, as
amended
|
X
|
||
Certification
of Principal Executive Officer and Principal Financial and Accounting
Officer Pursuant to 18 U.S.C. Section 1350*
|