Delaware
|
86-0585310
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
Title
of each class
|
Name
of each exchange on which registered
|
Common
Stock, par value $.0005 per share
|
NASDAQ
Global Market
|
Rights
to purchase 1/100 of a share of Series A Preferred Stock
|
NASDAQ
Global Market
|
PAGE
|
|||
PART I
|
2
|
||
Business
|
2
|
||
Risk Factors
|
7
|
||
Unresolved Staff Comments
|
17
|
||
Properties
|
17
|
||
Legal Proceedings
|
17
|
||
Submission of Matters to a Vote of Security
Holders
|
17
|
||
PART II
|
17
|
||
Market for Registrant’s Common Equity, Related
Stockholder Matters and Issuer Purchase of Equity
Securities
|
17
|
||
Selected Financial Data
|
18
|
||
Management’s Discussion and Analysis of Financial
Condition and Results of Operations
|
21
|
||
Quantitative and Qualitative Disclosures about
Market Risk
|
26
|
||
Financial Statements and Supplementary
Data
|
26
|
||
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
|
26
|
||
Controls and Procedures
|
27
|
||
Other Information
|
27
|
||
PART III
|
27
|
||
Directors, Executive Officers and Corporate
Governance
|
27
|
||
Executive Compensation
|
28
|
||
Security Ownership of Certain Beneficial Owners
and Management and Related
Stockholders
Matters
|
28
|
||
Certain Relationships and Related Transactions,
and Director Independence
|
28
|
||
Principal Accountant Fees and
Services
|
28
|
||
PART
IV
|
28
|
||
Exhibits
and Financial Statement Schedules
|
28
|
||
S-1
|
|||
EXHIBIT INDEX | E-1 | ||
F-1
|
Business
|
Risk
Factors
|
|
·
|
unfavorable
results of our product candidate development
efforts;
|
|
·
|
unfavorable
results of our pre-clinical or clinical
testing;
|
|
·
|
delays
in obtaining, or failure to obtain FDA
approvals;
|
|
·
|
increased
regulation by the FDA and other
agencies;
|
|
·
|
the
introduction of competitive
products;
|
|
·
|
impairment
of license, patent or other proprietary
rights;
|
|
·
|
failure
to achieve market acceptance of our
products;
|
|
·
|
the
impact of present and future collaborative or partnering agreements or the
lack thereof;
|
|
·
|
failure
to successfully implement our drug development strategy;
and
|
|
·
|
failure
in the future to meet the requirements for continued listing on the NASDAQ
Markets.
|
·
|
Acceleration of Fracture Repair | Phase 3 / Phase 2b human clinical trials | |
·
|
Diabetic Foot Ulcer Healing | Phase 1/2 human clinical trials | |
|
·
|
Spine
Fusion
|
Phase
1/2 human clinical trials
|
|
·
|
Cartilage
Defect Repair
|
Late
stage pre-clinical trials
|
|
·
|
Tendon
Repair
|
Early
stage pre-clinical trials
|
|
·
|
Cardiovascular
Repair
|
Pre-clinical
trials
|
|
·
|
Dental
Bone Repair
|
Pre-clinical
trials
|
|
·
|
Scarring
|
IND
filed in 2007, Phases 1 and 1b safety studies completed in
2008.
|
|
·
|
the
FDA finds some or all of our product candidates ineffective or
unsafe;
|
|
·
|
we
do not receive necessary regulatory
approvals;
|
|
·
|
we
are unable to get some or all of our product candidates to market in a
timely manner;
|
|
·
|
we
are not able to produce our product candidates in commercial quantities at
reasonable costs;
|
|
·
|
our
products undergo post-market evaluations resulting in marketing
restrictions or withdrawal of our products;
or
|
|
·
|
the
patients, insurance and/or physician community does not accept our
products.
|
|
In
addition, our product development programs may be curtailed, redirected or
eliminated at any time for many reasons,
including:
|
|
·
|
adverse
or ambiguous results;
|
|
·
|
undesirable
side effects which delay or extend the
trials;
|
|
·
|
inability
to locate, recruit, qualify and retain a sufficient number of patients for
our trials;
|
|
·
|
regulatory
delays or other regulatory actions;
|
|
·
|
difficulties
in obtaining sufficient quantities of the particular product candidate or
any other components needed for our pre-clinical testing or clinical
trials;
|
|
·
|
change
in the focus of our development efforts;
and
|
|
·
|
re-evaluation
of our clinical development
strategy.
|
|
·
|
pay
substantial damages;
|
|
·
|
stop
using our technologies;
|
|
·
|
stop
certain research and development
efforts;
|
|
·
|
develop
non-infringing products or methods;
and
|
|
·
|
obtain
one or more licenses from third
parties.
|
|
·
|
negative
or ambiguous pre-clinical or clinical trial
results;
|
|
·
|
changes
in regulations or the adoption of new
regulations;
|
|
·
|
unexpected
technological developments; and
|
|
·
|
developments
by our competitors that are more effective than our product
candidates.
|
|
·
|
announcement
of the results of, or delays in, preclinical and clinical
studies;
|
|
·
|
fluctuations
in our operating results;
|
|
·
|
developments
in litigation to which we or a competitor is
subject;
|
|
·
|
announcements
and timing of potential acquisitions, divestitures, capital raising
activities or issuance of preferred
stock;
|
|
·
|
announcements
of technological innovations or new products by us or our
competitors;
|
|
·
|
FDA
and other regulatory actions;
|
|
·
|
developments
with respect to our or our competitors’ patents or proprietary
rights;
|
|
·
|
public
concern as to the safety of products developed by us or
others;
|
|
·
|
changes
in stock market analyst recommendations regarding us, other drug
development companies or the pharmaceutical industry generally;
and
|
|
·
|
failure
in the future to meet the requirements for continued listing on the NASDAQ
markets.
|
|
·
|
a
classified board of directors with three-year staggered
terms;
|
|
·
|
advance
notice procedures for stockholder proposals to be considered at
stockholders’ meetings;
|
|
·
|
the
ability of our board of directors to fill vacancies on the
board;
|
|
·
|
a
prohibition against stockholders taking action by written consent;
and
|
|
·
|
super
majority voting requirements for the stockholders to modify or amend our
bylaws and specified provisions of our amended and restated certificate of
incorporation.
|
Item
1B.
|
Unresolved
Staff Comments
|
Properties
|
Legal
Proceedings
|
Submission
of Matters to a Vote of Security
Holders
|
Market
for the Registrant’s Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities
|
2008
|
2007
|
|||||||||||||||
High
|
Low
|
High
|
Low
|
|||||||||||||
First
Quarter
|
$ | 1.34 | $ | 0.79 | $ | 1.80 | $ | 1.35 | ||||||||
Second
Quarter
|
$ | 1.09 | $ | 0.79 | $ | 1.64 | $ | 1.40 | ||||||||
Third
Quarter
|
$ | 0.99 | $ | 0.72 | $ | 1.60 | $ | 1.35 | ||||||||
Fourth
Quarter
|
$ | 0.95 | $ | 0.40 | $ | 1.59 | $ | 1.28 |
Month
|
Total
Number of shares purchased
|
Average
price paid per share
|
Total
number of shares purchased as part of publicly announced
program
|
Maximum
number of shares that may yet be purchased under the
program
|
||||||||||||
November
1 - 30
|
18,804 | $ | 0.48 | 18,804 | ||||||||||||
December
1 - 31
|
30,022 | $ | 0.50 | 30,022 | 950,000 |
Selected
Financial Data
|
Years
Ended December 31,
|
||||||||||||||||||||
2008
|
2007
|
2006(1)
|
2005(2)
|
2004(3)
|
||||||||||||||||
Operating
expenses
|
||||||||||||||||||||
General
and administrative
|
$ | 2,991 | $ | 3,738 | $ | 6,558 | $ | 4,910 | $ | 3,306 | ||||||||||
Research
and development
|
10,693 | 9,641 | 19,661 | 25,444 | 17,116 | |||||||||||||||
Purchased
in-process research and development
|
- | - | 8,471 | - | 25,840 | |||||||||||||||
Other
|
- | - | - | (250 | ) | (347 | ) | |||||||||||||
Total
operating expenses
|
13,684 | 13,379 | 34,690 | 30,104 | 45,915 | |||||||||||||||
Interest
and other income, net
|
(2,082 | ) | (3,278 | ) | (3,883 | ) | (2,640 | ) | (1,464 | ) | ||||||||||
Loss
from continuing operations before taxes
|
11,602 | 10,101 | 30,807 | 27,464 | 44,451 | |||||||||||||||
Income
taxes expense (benefit)
|
(363 | ) | 1,106 | (108 | ) | (642 | ) | |||||||||||||
Loss
from continuing operations
|
11,239 | 10,101 | 31,913 | 27,356 | 43,809 | |||||||||||||||
Discontinued
operations
|
||||||||||||||||||||
Net
gain on the sale of the bone device business net of taxes $0, $0, $0, $96,
($363) respectively
|
- | - | - | (154 | ) | (2,048 | ) | |||||||||||||
NET
LOSS
|
$ | 11,239 | $ | 10,101 | $ | 31,913 | $ | 27,202 | $ | 41,761 | ||||||||||
Per
Share Information:
|
||||||||||||||||||||
Net
loss from continuing operations basic and diluted
|
$ | 0.27 | $ | 0.24 | $ | 0.78 | $ | 0.72 | $ | 1.22 | ||||||||||
Net
(income) from discontinued operations basic and diluted
|
$ | - | $ | - | $ | - | $ | - | $ | (0.06 | ) | |||||||||
Net
loss basic and diluted
|
$ | 0.27 | $ | 0.24 | $ | 0.78 | $ | 0.72 | $ | 1.16 | ||||||||||
Basic
and diluted shares outstanding
|
41,078 | 41,644 | 40,764 | 38,032 | 35,899 |
1.
|
Research
and development expenses in 2006 include recognition of a $2,100,000
Chrysalin patent cost impairment loss. Operating expenses in
2006 included $8,471,000 of purchased in-process research and development
costs associated with the AzERx acquisition in February
2006. Income tax expenses in 2006 included the recording of a
$1,106,000 valuation allowance for a deferred tax asset related to a
Alternative Minimum Tax credit
carryover.
|
2.
|
Total
operating expenses in 2005 were reduced by $250,000 as a result of a final
settlement payment received from the buyer of the CPM
business. A net gain of $154,000 was recognized on the sale of
the Bone Device Business due to receipt of the entire escrow deposit
outstanding.
|
3.
|
On
August 5, 2004, we completed the acquisition of CBI. OrthoLogic
expensed in-process research and
development and acquisition costs of $25.8
million.
|
December
31,
|
||||||||||||||||||||
2008
|
2007
|
2006
|
2005
|
2004
|
||||||||||||||||
Working
capital
|
$ | 44,865 | $ | 37,684 | $ | 52,533 | $ | 78,423 | $ | 88,955 | ||||||||||
Total
assets
|
$ | 49,514 | $ | 61,862 | $ | 72,589 | $ | 88,343 | $ | 115,184 | ||||||||||
Long
term liabilities, less current maturities
|
$ | - | $ | - | $ | - | $ | 183 | $ | 137 | ||||||||||
Stockholders’
equity
|
$ | 47,522 | $ | 59,461 | $ | 69,148 | $ | 84,178 | $ | 110,930 |
Management’s
Discussion and Analysis of Financial Conditions and Results of
Operations
|
|
·
|
We
believe that the results of our efforts to date support that Chrysalin may
have potential therapeutic value in tissues and diseases exhibiting
endothelial dysfunction.
|
|
·
|
We
are continuing pre-clinical experiments tying Chrysalin to potential
modulation of the health of endothelial tissue in blood vessels and other
mechanism-of-action studies.
|
|
·
|
We
are focusing our efforts on vascular product candidates and are not
currently planning additional pre-clinical or clinical studies in fracture
repair, wound healing, spine fusion, cartilage defect repair, dental bone
repair or tendon repair.
|
|
·
|
Although
we do not currently plan to re-enter clinical trials with Chrysalin, we
will perform pre-clinical and clinical studies which we believe would
serve to strengthen our portfolio and partnering
possibilities.
|
Item
7A.
|
Quantitative
and Qualitative Disclosures about Market
Risk
|
Financial
Statements and Supplementary Data
|
Changes
in and Disagreements with Accountants on Accounting and Financial
Disclosure
|
Item 9A(T).
|
Controls
and Procedures
|
Other
Information
|
Item
10.
|
Directors,
Executive Officers and Corporate
Governance
|
Item
11.
|
Executive
Compensation
|
Item 12.
|
Security
Ownership of Certain Beneficial Owners and Management and
Related Stockholders
Matters
|
Item
13.
|
Certain
Relationships and Related Transactions, and Director
Independence
|
Item
14.
|
Principal
Accountant Fees and Services
|
Item 15.
|
Exhibits
and Financial Statement Schedules
|
(a)
|
The following
documents are filed as part of this
report:
|
1.
|
Financial
Statements.
|
2.
|
Financial
Statement Schedules have been omitted since they are not
applicable.
|
3.
|
All
management contracts and compensatory plans and arrangements are
specifically identified on the attached Exhibit
Index.
|
(b)
|
Exhibits
|
(c)
|
Financial Statements
and Schedules - See Item 15(a)(1) and Item 15(a)(2)
above.
|
ORTHOLOGIC
CORP.
|
|||
Date: March
13, 2009
|
By
|
/s/ John M. Holliman, III
|
|
John
M. Holliman, III
|
|||
Executive
Chairman
|
Signature
|
Title
|
Date
|
/s/ John M. Holliman, III
John
M. Holliman, III
|
Executive
Chairman
(Principal
Executive Officer)
and
Director
|
March
13, 2009
|
/s/ Fredric J. Feldman
Fredric
J. Feldman, Ph.D.
|
Director
|
March
13, 2009
|
/s/ Elwood D. Howse, Jr.
Elwood
D. Howse, Jr.
|
Director
|
March
13, 2009
|
/s/ William M. Wardell
William
M. Wardell, MD, Ph.D.
|
Director
|
March
13, 2009
|
/s/ Augustus A. White, III
Augustus
A. White III, MD.
|
Director
|
March
13, 2009
|
/s/ Randolph C. Steer
Randolph
C. Steer, MD, Ph.D.
|
President
|
March
13, 2009
|
/s/ Les M. Taeger
Les
M. Taeger
|
Senior
Vice President and Chief Financial Officer (Principal Financial
and Accounting Officer)
|
March
13, 2009
|
Exhibit
No.
|
Description
|
Incorporated by Reference
To:
|
Filed
Herewith
|
|||
|
||||||
2.1
|
Asset
Purchase Agreement and Plan of Reorganization by and between OrthoLogic
Corp. and Chrysalis Biotechnology, dated April 28, 2004
(*)
|
Exhibit 2.1
to the Company’s Registration Statement on Form S-4 filed with the
SEC on June 3, 2004 (“June 2004 S-4”)
|
||||
2.2
|
Amendment
No. 1 to Asset Purchase Agreement and Plan of Reorganization by and
between OrthoLogic Corp. and Chrysalis Biotechnology, dated June 1,
2004 (*)
|
Exhibit 2.2
to the Company’s June 2004 S-4
|
||||
2.3
|
Amendment
No. 2 to Asset Purchase Agreement and Plan of Reorganization between
OrthoLogic Corp. and Chrysalis Biotechnology, Inc., dated August 5,
2004 (*)
|
Exhibit 2.1
to the Company’s Current Report on Form 8-K filed on August 6,
2004
|
||||
2.4
|
Asset
Purchase Agreement and Plan of Reorganization by and between OrthoLogic
Corp. and AzERx, Inc., dated February 23, 2006 (*)
|
Exhibit
10.1 to the Company’s Registration Statement on Form S-3 filed with the
SEC on April 25, 2006
|
||||
3.1
|
Restated
Certificate of Incorporation, executed April 15, 2005
|
Exhibit
3.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2005, filed with the SEC on May 10, 2005 (“March 2005
10-Q”)
|
||||
3.2
|
Amended
and Restated Certificate of Designation of Series A Preferred Stock,
executed June 19, 2007
|
Exhibit
3.1 to the Company’s Current Report on Form 8-K filed with the SEC on June
25, 2007 (“June 25th
2007 8-K”)
|
||||
3.3
|
Bylaws
of the Company
|
Exhibit
3.4 to the Company’s Amendment No. 2 to Registration Statement
on Form S-1 (No. 33-47569) filed with the SEC on January 25,
1993 (“January 1993 S-1”)
|
||||
4.1
|
Class
A Warrant Agreement dated February 24, 2006, between OrthoLogic Corp. and
PharmaBio Development Inc. (d/b/a NovaQuest)
|
Exhibit
4.1 to the Company’s Current Report on Form 8-K filed with the SEC on
March 3, 2006
|
||||
4.2
|
Form
of Additional Class A Warrant Agreement related to the Common Stock and
Warrant Purchase Agreement by and between OrthoLogic Corp. and PharmaBio
Development, Inc.
|
Exhibit
4.8 to the Company’s Registration Statement on Form S-3 filed with the SEC
on April 13, 2006 (“April 2006 S-3”)
|
||||
4.3
|
Class
A Warrant Agreement dated June 30, 2006 by and between OrthoLogic Corp.
and PharmaBio Development, Inc
|
Exhibit
4.1 to the Company’s Current Report on Form 8-K filed with the SEC on July
6, 2006
|
||||
4.4
|
Amended
and Restated Class B Warrant Agreement dated February 24,
2006, and amended and restated as of June 30, 2006, related to the Common
Stock and Warrant Purchase Agreement by and between OrthoLogic Corp. and
PharmaBio Development, Inc. (2)
|
Exhibit
4.5 to the Company’s Amendment No. 1 to Registration Statement on Form S-3
filed with the SEC on September 22, 2006 (“September 2006
S-3/A”)
|
4.5
|
Amended
and Restated Class C Warrant Agreement dated February 24, 2006,
and amended and restated as of June 30, 2006, related to the Common Stock
and Warrant Purchase Agreement by and between OrthoLogic Corp. and
PharmaBio Development, Inc.
|
Exhibit
4.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2007, filed with the SEC on May 7, 2007
|
||||
4.6
|
Amended
and Restated Class D Warrant Agreement dated February 24, 2006, and
amended and restated as of June 30, 2006, related to the Common Stock and
Warrant Purchase Agreement by and between OrthoLogic Corp. and PharmaBio
Development, Inc.
|
Exhibit
4.6 to the Company’s Annual Report on Form 10-K for the year ended
December 31, 2007, filed with the SEC on March 5, 2008.
|
||||
4.7
|
Rights
Agreement, dated as of June 19, 2007, between OrthoLogic Corp. and the
Bank of New York
|
Exhibit
4.1 to the June 25th
2007 8-K
|
||||
10.1
|
Form
of Indemnification Agreement(**)
|
Exhibit 10.16
to the Company’s January 1993 S-1
|
||||
10.2
|
1997
Stock Option Plan of the Company, as amended and approved by the
stockholders (1)
|
Exhibit
4.3 to the Company’s Registration Statement on Form S-8, filed with the
SEC on March 2, 2005
|
||||
10.3
|
Single-tenant
Lease dated June 12, 1997, by and between the Company and Chamberlain
Development, L.L.C.
|
Exhibit 10.2
to the Company’s Quarterly Report on Form 10-Q for the quarter ended
September 30, 1997, filed with the SEC on November 14,
1997
|
||||
10.4
|
Patent
License Agreement between the Board of Regents of The University of Texas
System through its component institution The University of Texas Medical
Branch at Galveston and Chrysalis Biotechnology, Inc., dated
April 27, 2004 and exhibits thereto (2)
|
Exhibit 10.1
to the Company’s Amendment No. 1 to its Registration Statement on
Form S-4, filed July 14, 2004
|
||||
10.5
|
Form
of Incentive Stock Option Grant Letter for use in connection with the
Company’s 1997 Stock Option Plan (***)
|
Exhibit 10.1
to the Company’s Current Report on Form 8-K filed on January 4,
2005
|
||||
10.6
|
Form
of Non-qualified Stock Option Grant Letter for use in connection with the
Company’s 1997 Stock Option Plan (***)
|
Exhibit 10.1
to the Company’s Current Report on Form 8-K filed on January 19,
2006
|
||||
10.7
|
Patent
Assignment Agreement dated June 28, 2005, between the Company and the
University of Texas
|
Exhibit
10.3 to the Company’s Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 2005, filed with the SEC on August 9, 2005 (the
“June 2005 10-Q”)
|
||||
10.8
|
Director
Compensation Plan, effective June 10, 2005 (1)
|
Exhibit
10.2 to the June 2005 10-Q
|
||||
10.9
|
Letter
of Stock Option Grant to Dr. James M. Pusey for 200,000
shares of the Company’s common stock, dated March 3, 2005
(1)
|
Exhibit
10.3 to the March 4th,
2005 8-K
|
||||
10.10
|
Letter
of Stock Option Grant to Dr. James M. Pusey for 300,000
shares of the Company’s common stock, dated March 3, 2005
(1)
|
Exhibit
10.4 to the March 4th,
2005 8-K
|
||||
10.11
|
Employment
Agreement between the Company and Dana Shinbaum, dated October 17, 2005
(1)
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
October 27, 2005
|
||||
10.12
|
Employment
Agreement dated January 10, 2006 between the Company and Les M. Taeger
(1)
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
January 11, 2006 (the “January 11th
8-K”)
|
10.13
|
Intellectual
Property, Confidentiality and Non-Competition Agreement between the
Company and Les M. Taeger dated January 10, 2006 (1)
|
Exhibit
10.2 to the January 11th
8-K
|
||||
10.14
|
Separation
Agreement and Release dated April 5, 2006 by and between OrthoLogic Corp.
and James M. Pusey (1)
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
April 11, 2006
|
||||
10.15
|
Common
Stock and Warrant Purchase Agreement by and between OrthoLogic Corp. and
PharmaBio Development, Inc., dated February 24, 2006.
|
Exhibit
10.1 to the Company’s April 2006 S-3
|
||||
10.16
|
Registration
Rights Agreement by and between OrthoLogic Corp. and PharmaBio
Development, Inc., dated February 24, 2006
|
Exhibit
10.2 to the Company’s April 2006 S-3
|
||||
10.17
|
Registration
Rights Agreement by and between OrthoLogic Corp., AzERx, Inc., and Certain
Shareholders, dated February 27, 2006
|
Exhibit
10.3 to the Company’s April 2006 S-3
|
||||
10.18
|
Amended
and Restated License Agreement dated February 23, 2006 by and between
OrthoLogic Corp. and Arizona Science Technology Enterprises,
LLC
|
Exhibit
10.5 to the Company’s Registration Statement on Form S-3 filed with the
SEC on April 25, 2006
|
||||
10.19
|
2005
Equity Incentive Plan (2005 Plan) (1)
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May
18, 2006
|
||||
10.20
|
Form
of Incentive Stock Option Grant Letters for Grants under the 2005 Plan
(***)
|
Exhibit
10.1 to the Company’s Report on Form 10-Q for the quarterly period ended
June 30, 2006, filed on August 8, 2006 (“June 2006 10-Q”)
|
||||
10.21
|
Form
of Non-Qualified Stock Options Grant Letter for Grants under the 2005 Plan
(***)
|
Exhibit
10.2 to the Company’s June 2006 10-Q
|
||||
10.22
|
Form
of Restricted Stock Grant Letters for Grants under the 2005
Plan
|
Exhibit
10.4 to the Company’s Current Report on Form 8-K filed with the SEC on May
18, 2006
|
||||
10.23
|
Amendment
to Employment Agreement dated January 10, 2006 between OrthoLogic Corp.
and Les Taeger (1)
|
Exhibit
10.3 to the Company’s June 2006 10-Q
|
||||
10.24
|
Employment
Agreement between Randolph C. Steer, MD, Ph.D., President, and OrthoLogic
Corp., effective May 12, 2006 (1)
|
Exhibit
10.7 to the Company’s June 2006 10-Q
|
||||
10.25
|
Management
Service Agreement between Valley Venture III, Management LLC, John M.
Holliman, III, Executive Chairman and OrthoLogic Corp., effective May 12,
2006 (1)
|
Exhibit
10.8 to the Company’s June 2006 10-Q
|
||||
10.26
|
Amendment
No.1 to Registration Rights Agreement dated June 30, 2006 by and between
PharmaBio Development, Inc., and OrthoLogic Corp.
|
Exhibit
10.4 to the Company’s September 2006 S-3/A
|
||||
10.27
|
Separation
Agreement and Release dated November 17, 2006 by and between OrthoLogic
Corp., and James T. Ryaby, Ph.D. (1)
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
November 24, 2006 (“November 24th 8-K”)
|
||||
10.28
|
Consulting
Agreement dated November 17, 2006 by and between James T. Ryaby, Ph.D.,
and OrthoLogic Corp. (1)
|
Exhibit
10.2 to the Company’s November 24th 8-K
|
10.29
|
Lease
Agreement dated July 19, 2007, by and between the Company and Phoenix
Investors #13, L.L.C.
|
Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on
July 23, 2007
|
||||
10.30
|
Amendment
#1 to Employment Agreement dated May 21, 2007, between Randolph C. Steer,
MD, Ph.D., President, and OrthoLogic Corp.
|
Exhibit
10.30 to the Company’s Annual Report on Form 10-K for the year ended
December 31, 2007, filed with the SEC on March 5, 2008.
|
|
|||
10.31
|
Amendment
#2 to Employment Agreement dated February 21, 2008, between Randolph C.
Steer, MD, Ph.D., President, and OrthoLogic Corp.
|
Exhibit
10.31 to the Company’s Annual Report on Form 10-K for the year ended
December 31, 2007, filed with the SEC on March 5, 2008.
|
|
|||
10.32
|
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)
|
Exhibit
10.1 to the Company’s Quarterly Report on Form 10-Q for the quarterly
period ended September 30, 2008, filed with the SEC on November 6, 2008
(the “November 6, 2008 10-Q”)
|
||||
10.33
|
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)
|
Exhibit
10.2 to the Company’s November 6, 2008 10-Q
|
||||
16.1
|
Letter
from Deloitte and Touche, LLP, to the SEC dated June 19,
2006
|
Exhibit
16.1 to the Company’s Current Report on Form 8-K filed with the SEC on
June 20, 2006
|
||||
Consent
of independent registered public accounting firm.
|
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****
|
(1)
|
Management
contract or compensatory plan or
arrangement.
|
(2)
|
Portions
of this agreement have been redacted and filed under confidential
treatment request with the Securities and Exchange
Commission.
|
/s/ Ernst & Young LLP |
|
Ernst & Young LLP |
December
31,
|
December
31,
|
|||||||
2008
|
2007
|
|||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$ | 23,088 | $ | 20,943 | ||||
Short-term
investments
|
22,675 | 18,236 | ||||||
Prepaids
and other current assets
|
1,094 | 906 | ||||||
Total
current assets
|
46,857 | 40,085 | ||||||
Furniture
and equipment, net
|
436 | 318 | ||||||
Long-term
investments
|
2,221 | 21,459 | ||||||
Total
assets
|
$ | 49,514 | $ | 61,862 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$ | 1,063 | $ | 702 | ||||
Accrued
compensation
|
648 | 824 | ||||||
Other
accrued liabilities
|
281 | 875 | ||||||
Total
current liabilities
|
1,992 | 2,401 | ||||||
Stockholders'
Equity
|
||||||||
Common
Stock $.0005 par value; 100,000,000 shares authorized;
40,775,411 shares in 2008 and 41,758,065 shares in 2007 issued
and outstanding
|
20 | 21 | ||||||
Additional
paid-in capital
|
188,314 | 189,013 | ||||||
Accumulated
deficit
|
(140,812 | ) | (129,573 | ) | ||||
Total
stockholders' equity
|
47,522 | 59,461 | ||||||
Total
liabilities and stockholders' equity
|
$ | 49,514 | $ | 61,862 |
Years
ended December 31,
|
As
a Development Stage Company August 5, 2004-
|
|||||||||||
2008
|
2007
|
December
31, 2008
|
||||||||||
OPERATING
EXPENSES
|
||||||||||||
General
and administrative
|
$ | 2,991 | $ | 3,738 | $ | 20,075 | ||||||
Research
and development
|
10,693 | 9,641 | 73,519 | |||||||||
Purchased
in-process research and development
|
- | - | 34,311 | |||||||||
Other
|
- | - | (375 | ) | ||||||||
Total
operating expenses
|
13,684 | 13,379 | 127,530 | |||||||||
Interest
and other income, net
|
(2,082 | ) | (3,278 | ) | (12,634 | ) | ||||||
Loss
from continuing operations before taxes
|
11,602 | 10,101 | 114,896 | |||||||||
Income
tax benefit
|
(363 | ) | - | (7 | ) | |||||||
Loss
from continuing operations
|
11,239 | 10,101 | 114,889 | |||||||||
Discontinued
Operations
|
||||||||||||
Net
gain on the sale of the bone device business, net of taxes of
$267
|
- | - | (2,202 | ) | ||||||||
NET
LOSS
|
$ | 11,239 | $ | 10,101 | $ | 112,687 | ||||||
Per
Share Information:
|
||||||||||||
Net
loss, basic and diluted
|
$ | 0.27 | $ | 0.24 | ||||||||
Basic
and diluted shares outstanding
|
41,078 | 41,644 |
Common
Stock
|
Additional
|
Accumulated
|
||||||||||||||||||
Shares
|
Amount
|
Paid in Capital
|
Deficit
|
Total
|
||||||||||||||||
Balance
December 31, 2006
|
41,564 | $ | 21 | $ | 188,236 | $ | (119,109 | ) | $ | 69,148 | ||||||||||
Adoption
of FIN 48
|
- | - | - | (363 | ) | (363 | ) | |||||||||||||
Stock
option compensation cost
|
- | - | 534 | - | 534 | |||||||||||||||
Compensation
earned on stock awards
|
194 | - | 243 | - | 243 | |||||||||||||||
Net
loss
|
- | - | - | (10,101 | ) | (10,101 | ) | |||||||||||||
Balance
December 31, 2007
|
41,758 | 21 | 189,013 | (129,573 | ) | 59,461 | ||||||||||||||
Stock
option compensation cost
|
- | - | 177 | - | 177 | |||||||||||||||
Compensation
earned on stock awards
|
149 | - | 164 | - | 164 | |||||||||||||||
Common
stock purchased and retired
|
(1,132 | ) | (1 | ) | (1,040 | ) | - | (1,041 | ) | |||||||||||
Net
loss
|
- | - | - | (11,239 | ) | (11,239 | ) | |||||||||||||
Balance
December 31, 2008
|
40,775 | $ | 20 | $ | 188,314 | $ | (140,812 | ) | $ | 47,522 |
Years
Ended December 31,
|
As
a Development Stage Company August 5th 2004 -
|
|||||||||||
2008
|
2007
|
December
31, 2008
|
||||||||||
OPERATING
ACTIVITIES
|
||||||||||||
Net
loss
|
$ | (11,239 | ) | $ | (10,101 | ) | $ | (112,687 | ) | |||
Non
cash items:
|
||||||||||||
Deferred
tax expense
|
- | - | 770 | |||||||||
Depreciation
and amortization
|
131 | 169 | 3,565 | |||||||||
Non-cash
stock compensation
|
341 | 777 | 4,061 | |||||||||
Gain
on sale of bone device business
|
- | - | (2,298 | ) | ||||||||
In-process
research and development
|
- | - | 34,311 | |||||||||
Change
in other operating items:
|
||||||||||||
Prepaids
and other current assets
|
(189 | ) | 1,044 | 614 | ||||||||
Accounts
payable
|
361 | (919 | ) | 92 | ||||||||
Accrued
liabilities
|
(768 | ) | (384 | ) | (2,085 | ) | ||||||
Cash
flows used in operating activities
|
(11,363 | ) | (9,414 | ) | (73,657 | ) | ||||||
INVESTING
ACTIVITIES
|
||||||||||||
Expenditures
for furniture and equipment, net
|
(250 | ) | (178 | ) | (943 | ) | ||||||
Proceeds
from sale of assets
|
- | - | 7,000 | |||||||||
Cash
paid for assets of AzERx/CBI
|
- | - | (4,058 | ) | ||||||||
Cash
paid for patent assignment rights
|
- | - | (650 | ) | ||||||||
Purchases
of investments
|
(29,757 | ) | (51,395 | ) | (227,046 | ) | ||||||
Maturities
of investments
|
44,556 | 63,883 | 260,088 | |||||||||
Cash
flows provided by investing activities
|
14,549 | 12,310 | 34,391 | |||||||||
FINANCING
ACTIVITIES
|
||||||||||||
Net
proceeds from stock option exercises
|
- | - | 4,612 | |||||||||
Net
proceeds from sale of stock
|
- | - | 3,376 | |||||||||
Common
stock purchases
|
(1,041 | ) | (1,041 | ) | ||||||||
Cash
flows (used in) provided by financing activities
|
(1,041 | ) | - | 6,947 | ||||||||
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
|
2,145 | 2,896 | (32,319 | ) | ||||||||
CASH
AND CASH EQUIVALENTS, BEGINNING OF YEAR
|
20,943 | 18,047 | 55,407 | |||||||||
CASH
AND CASH EQUIVALENTS, END OF YEAR
|
$ | 23,088 | $ | 20,943 | $ | 23,088 | ||||||
Supplemental
Disclosure of Non-Cash Investing Activities AzERx / CBI
Acquisitions
|
||||||||||||
Current
assets acquired
|
$ | - | $ | - | $ | 29 | ||||||
Patents
acquired
|
- | - | 2,142 | |||||||||
Liabilities
acquired, and accrued acquisition costs
|
- | - | (457 | ) | ||||||||
Original
investment reversal
|
- | - | (750 | ) | ||||||||
In-process
research and development acquired
|
- | - | 34,311 | |||||||||
Common
stock issued for acquisitions
|
- | - | (31,217 | ) | ||||||||
Cash
paid for acquisitions
|
$ | - | $ | - | $ | 4,058 |
1.
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
2008
|
2007
|
|||||||
Balance
at January 1
|
$ | 1,001,000 | $ | 1,001,000 | ||||
Additions
based on tax positions related to the current year
|
- | - | ||||||
Additions
for tax positions of prior years
|
- | - | ||||||
Reductions
for tax positions of prior years
|
- | - | ||||||
Settlements
|
- | - | ||||||
Reductions
due to lapse in statute of limitations
|
$ | (363,000 | ) | - | ||||
Balance
at December 31
|
$ | 638,000 | $ | 1,001,000 |
2.
|
ASSET
ACQUISITION OF CHRYSALIS BIOTECHNOLOGY,
INC
|
3.
|
INVESTMENTS
AND FAIR VALUE DISCLOSURES
|
Investments
with maturities – Short-term
|
December
31,
|
|||||||
2008
|
2007
|
|||||||
Amortized
cost
|
$ | 22,675 | $ | 18,236 | ||||
Unrealized
gain
|
528 | 117 | ||||||
Fair
value
|
$ | 23,203 | $ | 18,353 |
Investments
with maturities – Long term
|
December
31,
|
|||||||
2008
|
2007
|
|||||||
Amortized
cost
|
$ | 2,221 | $ | 21,459 | ||||
Unrealized
gain
|
104 | 610 | ||||||
Fair
value
|
$ | 2,325 | $ | 22,069 |
4.
|
FURNITURE
AND EQUIPMENT
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Machinery
and equipment
|
$ | 1,116 | $ | 1,258 | ||||
Furniture
and fixtures
|
69 | 144 | ||||||
Leasehold
improvements
|
36 | - | ||||||
1,221 | 1,402 | |||||||
Less
accumulated depreciation and amortization
|
(785 | ) | (1,084 | ) | ||||
Total
|
$ | 436 | $ | 318 |
5.
|
INCOME
TAXES
|
December
31,
|
||||||||
2008
|
2007
|
|||||||
Accruals
and reserves
|
$ | 82 | $ | 328 | ||||
Valuation
allowance
|
(82 | ) | (328 | ) | ||||
Total
current
|
- | - | ||||||
NOL,
AMT and general business credit carryforwards
|
44,354 | 38,357 | ||||||
Difference
in basis of fixed assets
|
79 | 93 | ||||||
Accruals
and reserves
|
808 | 756 | ||||||
Difference
in basis of intangibles
|
(37 | ) | 35 | |||||
Valuation
allowance
|
(45,204 | ) | (39,241 | ) | ||||
Total
non current
|
- | - | ||||||
Total
deferred income taxes
|
$ | - | $ | - |
Years
Ended December 31
|
As
a Development Stage
Company
August 5, 2004 -
|
|||||||||||
2008
|
2007
|
December
31, 2008
|
||||||||||
Provision
(benefit) for income taxes
|
||||||||||||
Current
|
$ | (363 | ) | $ | - | $ | (1,113 | ) | ||||
Deferred
|
- | - | 1,106 | |||||||||
Income
tax provision (benefit)
|
$ | (363 | ) | $ | - | $ | (7 | ) |
As
a Development Stage Company
|
||||||||||||
Years
Ended December 31,
|
August
5, 2004 -
|
|||||||||||
2008
|
2007
|
December
31, 2008
|
||||||||||
Income
tax provision (benefit) at statutory rate
|
$ | (3,945 | ) | $ | (3,434 | ) | $ | (39,062 | ) | |||
State
income taxes
|
(534 | ) | (465 | ) | (4,181 | ) | ||||||
Purchased
in-process research and development
|
- | - | 12,533 | |||||||||
Research
credits
|
(1,477 | ) | (1,516 | ) | (4,778 | ) | ||||||
Change
in FIN 48 reserve
|
(363 | ) | - | (363 | ) | |||||||
Other
|
156 | (291 | ) | 1,180 | ||||||||
Change
in valuation allowance
|
5,800 | 5,706 | 34,664 | |||||||||
Net
provision (benefit)
|
$ | (363 | ) | $ | - | $ | (7 | ) |
6.
|
STOCKHOLDERS’
EQUITY
|
Three
months ended
|
Three
months ended
|
Three
months ended
|
||||||||||
March
31, 2007
|
June
30, 2007
|
September
30, 2007
|
||||||||||
Risk
free interest rate
|
4.60 | % | 4.87 | % | 4.24 | % | ||||||
Volatility
|
66 | % | 61 | % | 59 | % | ||||||
Expected
term from vesting
|
2.8
Years
|
2.8
Years
|
2.9
Years
|
|||||||||
Dividend
yield
|
0 | % | 0 | % | 0 | % |
Three
months ended
|
||||
March
31, 2008
|
||||
Risk
free interest rate
|
2.4% - 3.4 | % | ||
Volatility
|
57% - 58 | % | ||
Expected
term from vesting
|
3.7
Years
|
|||
Dividend
yield
|
0 | % |
2008
|
2007
|
|||||||||||||||||||
Number
of Options
|
Weighted
average exercise price
|
Weighted
average remaining contractual term (years)
|
Number
of Options
|
Weighted
average exercise price
|
||||||||||||||||
Options
outstanding at the beginning of the year:
|
3,200,125 | $ | 3.43 | 3,438,126 | $ | 3.69 | ||||||||||||||
Granted
|
267,173 | $ | 1.08 | 214,889 | $ | 1.45 | ||||||||||||||
Exercised
|
- | - | ||||||||||||||||||
Forfeited
|
(476,994 | ) | $ | 4.96 | (452,890 | ) | $ | 4.47 | ||||||||||||
Outstanding
at end of year
|
2,990,304 | $ | 2.98 | 6.13 | 3,200,125 | $ | 3.43 | |||||||||||||
Options
exercisable at year-end
|
2,681,292 | $ | 3.04 | 5.89 | 2,581,336 | $ | 3.54 | |||||||||||||
Options
vested and expected to vest at December 31, 2008
|
2,807,719 | $ | 2.99 | 6.01 | 2,942,863 | $ | 3.44 |
Number
of
|
Weighted
average Grant date
|
|||||||
Unvested
Shares
|
Options
|
Fair
Value
|
||||||
Unvested
shares at December 31, 2006
|
||||||||
Granted
|
181,057 | $ | 1.46 | |||||
Vested
|
(163,574 | ) | $ | 1.47 | ||||
Canceled/forfeited
|
(17,483 | ) | $ | 1.43 | ||||
Unvested
shares at December 31, 2007
|
- | |||||||
Granted
|
148,968 | $ | 1.23 | |||||
Vested
|
(148,968 | ) | $ | 1.23 | ||||
Canceled/forfeited
|
- | |||||||
Unvested
shares at December 31, 2008
|
- |
7.
|
COMMITMENTS
|
8.
|
401(K)
PLAN
|
9.
|
AUTHORIZED
PREFERRED STOCK
|
10.
|
AUTHORIZATION
OF COMPANY BUY-BACK OF COMMON STOCK
|