|
(1)
|
Title
of each class of securities to which transaction
applies:
|
|
(2)
|
Aggregate
number of securities to which transaction
applies:
|
|
(3)
|
Per
unit price or other underlying value of transaction computed pursuant to
Exchange Act Rule 0-11 (set forth the amount on which the filing fee is
calculated and state how it was
determined):
|
|
(4)
|
Proposed
maximum aggregate value of
transaction:
|
|
(5)
|
Total
fee paid:
|
|
¨ Check
box if any part of the fee is offset as provided by Exchange Act Rule
0-11(a)(2) and identify the filing for which the offsetting fee
was paid previously. Identify the previous filing by
registration statement number, or the Form or Schedule and the date of its
filing.
|
|
By
Order of the Board of Directors
|
|
|
/s/ Eugene
A. Bauer
|
|
|
Eugene
A. Bauer
|
|
|
Chairman
of the Board
|
|
|
February
2, 2011
|
|
|
|
·
|
Purchase
Price
|
|
|
·
|
In total, (i) 25,031,253 shares
of Company Common Stock shall be issued to holders of MediSync Common
Stock, convertible notes and other indebtedness, (ii) warrants to purchase
2,090,000 shares of Company Common Stock shall be issued to holders of
MediSync warrants and (iii) options to purchase 1,010,250 shares of
Company Common Stock shall be issued to holders of MediSync
options.
|
|
|
·
|
Board Seats: two
current MediSync directors shall be appointed to the Vyteris Board of
Directors.
|
|
|
·
|
Closing date: On or
about February 22, 2011.
|
|
Title of Class
|
Name of Beneficial Owner
|
Number of
Shares
|
Percentage of
Outstanding Shares
in Class
|
Pro Forma
Effect of
Merger on
Percentage
of
Outstanding
Shares in
Class (8)
|
|||||||||
|
Common Stock:
|
|||||||||||||
|
5%
Holders
|
|||||||||||||
|
Kevin
Kimberlin (1)
|
53,038,896 | 46.6 | % | 41.8 | % | ||||||||
|
Global
Alpha Long Short Fund (2)
|
6,344,666 | 5.6 | % | 4.6 | % | ||||||||
|
Directors
and Officers:
|
Eugene
Bauer (3)
|
731,162 | - | 1.2 | % | ||||||||
|
Haro
Hartounian (5)
|
3,150,962 | 2.8 | % | 2.3 | % | ||||||||
|
John
Burrows (5)
|
297,313 | - | - | ||||||||||
|
Arthur
Courbanou (5)
|
377,145 | - | - | ||||||||||
|
David
DiGiacinto (4)
|
312,397 | - | - | ||||||||||
|
Susan
Guerin (5)
|
372,321 | - | - | ||||||||||
|
Joseph
Himy (5)
|
1,010,416 | - | - | ||||||||||
|
Joel
Kanter (9)
|
62,362 | - | 2.6 | % | |||||||||
|
Cormac
Lyons (5)
|
412,751 | - | - | ||||||||||
|
Michael
Reidy (5)
|
968,276 | - | - | ||||||||||
|
Russell
Potts (6)
|
320,893 | - | - | ||||||||||
|
Directors
and Officers as a Group
(11
persons) (7)
|
|||||||||||||
| 8,015,998 | 7.0 | % | 9.0 | % | |||||||||
|
1.
|
Represents (i) 49,024,414 shares
of Common Stock owned by STSG, of which Mr. Kimberlin is the non-managing
member; (ii) 244,633 shares of Common Stock issuable upon the exercise of
warrants acquired by STSG in connection with a line of credit extended to
the Company; (iii) 3,472 shares of Common Stock issuable upon the exercise
of warrants issued in connection with $2,00,000 aggregate principal amount
of subordinated convertible promissory notes issued to STSG in 2006; (iv)
2,328 shares of Common Stock issuable upon the exercise of warrants held
by STSG (excluding the warrants listed in clause (ii) above); (v) 18,544
shares of Common Stock owned by Scimitar Holdings, LLC, a New York limited
liability company and wholly-owned subsidiary of Spencer Trask & Co.,
a Delaware corporation of which Mr. Kimberlin is the controlling
stockholder and chairman; (vi) 286,386 shares of Common Stock issuable
upon the exercise of warrants issued to Spencer Trask Ventures, Inc., a
wholly-owned subsidiary of Spencer Trask & Co.; (vii) an aggregate
of 2,574,585 shares of Common Stock owned by Spencer
Trask Private Equity Fund I LP, Spencer Trask Private Equity Fund II LP,
Spencer Trask Private Equity Accredited Fund III LLC and Spencer Trask
Illumination Fund LLC (together, the “Funds”); (viii) 73,655 shares of
Common Stock issuable upon the exercise of warrants issued to the Funds
(Spencer Trask & Co. is the 100% owner of the manager of each of the
Funds); (ix) 13,670 shares of Common Stock issuable upon exercise of
warrants paid to Spencer Trask Ventures, Inc., as finders fees; (x)
532,209 shares of Common Stock issuable upon the exercise of warrants
issued to the Funds (Spencer Trask & Co. is the 100% owner of the
manager of each of the Funds) as result of the registration rights
settlement agreement; and (xi) 265,000 shares of Common Stock issuable
upon the exercise of warrants issued to the Spencer Trask Ventures, Inc.
on February 2, 2010 as our selling agent. The pro forma column
takes into account the foregoing plus (i) 2,750,000 shares of Common Stock
issuable to Spencer Trask Breakthrough Partners, LLC in the Merger and
(ii) 2,090,000 shares of Common Stock issuable upon the exercise of
warrants issuable to Spencer Trask Ventures, Inc. in the
Merger.
|
|
2.
|
Includes 3,144,666 shares of
Common Stock owned by Global Alpha Long Short Fund and 3,200,000 shares of
Common Stock issuable pursuant to the exercise of
warrants
|
|
3.
|
Represents (i)
250,0000 shares of Common Stock which are issuable upon the exercise
warrants (ii) 253,807 shares of Common Stock which are issuable upon the
conversion of convertible debentures and (iii) 227,355 shares
of Common Stock which are issuable upon the exercise of stock
options. For the pro forma percentage, represents the foregoing
as well as 564,572 shares of Vyteris Common Stock and 336,750 options to
purchase shares of Common Stock issuable to Eugene Bauer in the
Merger.
|
|
4.
|
Represents 310,852 shares of
Common Stock which are issuable upon the exercise of stock options and
1,545 shares of Common Stock. Mr. DiGiacinto, formally an employee of an
affiliate of STSG, disclaims beneficial ownership with respect to
securities owned by STSG and its affiliates, as he has no power to vote or
dispose of those securities.
|
|
5.
|
Represents shares of Common Stock
which are issuable upon the exercise of stock
options.
|
|
6.
|
Represents 319,348
shares of Common Stock which are issuable upon the exercise of stock
options and 1,545 shares of Common
Stock.
|
|
7.
|
Includes (i) 3,090 shares of
Common Stock; (ii) 250,0000 shares of Common Stock which are issuable upon
the exercise warrants (iii) 253,807 shares of Common Stock which are
issuable upon the conversion of convertible debentures and (iv)
7,509,101 shares of Common Stock which are issuable upon the
exercise of stock options. For the pro forma percentage,
includes the foregoing plus 564,572 shares of Common Stock to be issued to
Eugene Bauer in the Merger, 336,750 shares of Common Stock which are
issuable upon the exercise of stock options to be issued to Eugene Bauer
in the Merger, and 3,476,998 shares of Common Stock to be issued to Joel
Kanter in the Merger.
|
|
8.
|
Based upon 25,031,253 shares of
Common Stock to be issued in connection with the
Merger.
|
|
9.
|
Represents 62,362 shares of
Common Stock which are issuable upon the exercise of stock
options. With respect to the pro forma percentage,
represents the foregoing plus 3,476,998 shares of Common Stock to be
issued in connection with the
Merger.
|
|
By
Order of the Board of Directors
|
|
|
/s/ Eugene A. Bauer
|
|
|
Eugene
A. Bauer
|
|
|
Chairman
of the Board
|
|
|
February
2, 2011
|
|
Page
|
|||
|
SECTION
1. DEFINITIONS AND TERMS
|
1
|
||
|
1.1.
|
Definitions
|
1
|
|
|
1.2.
|
Usage
|
1
|
|
|
SECTION
2. THE MERGER
|
2
|
||
|
2.1.
|
Merger
|
2
|
|
|
2.2.
|
Closing
and Effective Time
|
2
|
|
|
2.3.
|
Certificate
of Incorporation; By-laws
|
3
|
|
|
2.4.
|
Officers
and Directors
|
3
|
|
|
2.5.
|
Deliveries
at Closing
|
3
|
|
|
SECTION
3. EFFECT OF MERGER
|
3
|
||
|
3.1.
|
Stock
and Debt Conversion; Cancellation
|
3
|
|
|
3.2.
|
MediSync
Warrants
|
4
|
|
|
3.3.
|
MediSync
Options
|
4
|
|
|
3.4.
|
Surrender
of Certificates and Notes
|
4
|
|
|
3.5.
|
Certain
Adjustments
|
5
|
|
|
SECTION
4. REPRESENTATIONS AND WARRANTIES OF MEDISYNC
|
5
|
||
|
4.1.
|
Organization
and Power
|
5
|
|
|
4.2.
|
Subsidiaries
|
5
|
|
|
4.3.
|
Authorization;
No Breach
|
6
|
|
|
4.4.
|
No
Violation
|
6
|
|
|
4.5.
|
Capitalization
|
6
|
|
|
4.6.
|
Financial
Statements
|
7
|
|
|
4.7.
|
Absence
of Certain Developments
|
8
|
|
|
4.8.
|
Real
Property
|
8
|
|
|
4.9.
|
Tangible
Personal Property
|
8
|
|
|
4.10.
|
Taxes
|
9
|
|
|
4.11.
|
Contracts
and Commitments
|
9
|
|
|
4.12.
|
Intellectual
Property
|
10
|
|
|
4.13.
|
Litigation
|
11
|
|
|
4.14.
|
Governmental
Consents
|
11
|
|
|
4.15.
|
Employees;
Labor Matters
|
11
|
|
|
4.16.
|
Employee
Benefits
|
12
|
|
|
4.17.
|
Compliance
with Laws
|
14
|
|
|
4.18.
|
Environmental
Compliance
|
14
|
|
|
4.19.
|
Undisclosed
Liabilities
|
14
|
|
|
4.20.
|
Insurance
|
14
|
|
|
4.21.
|
Permits
|
15
|
|
|
4.22.
|
Related
Party Transactions
|
15
|
|
|
4.23.
|
Brokerage
|
15
|
|
|
SECTION
5. REPRESENTATIONS AND WARRANTIES OF PARENT AND MERGER SUB
|
15
|
||
|
5.1.
|
Organization
and Power
|
16
|
|
|
5.2.
|
Subsidiaries
|
16
|
|
|
5.3.
|
Authorization;
No Breach
|
16
|
|
|
5.4.
|
No
Violation
|
16
|
|
|
5.5.
|
Capitalization
|
17
|
|
|
5.6.
|
Financial
Statements
|
17
|
|
|
5.7.
|
Absence
of Certain Developments
|
18
|
|
|
5.8.
|
Real
Property
|
18
|
|
|
5.9.
|
Tangible
Personal Property
|
18
|
|
|
5.10.
|
Taxes
|
19
|
|
|
5.11.
|
Contracts
and Commitments
|
19
|
|
|
5.12.
|
Intellectual
Property
|
21
|
|
|
5.13.
|
Litigation
|
21
|
|
|
5.14.
|
Governmental
Consents.
|
21
|
|
|
5.15.
|
Employees;
Labor Matters.
|
21
|
|
|
5.16.
|
Employee
Benefits.
|
22
|
|
|
5.17.
|
Compliance
with Laws
|
24
|
|
|
5.18.
|
Environmental
Compliance
|
24
|
|
|
5.19.
|
Undisclosed
Liabilities
|
24
|
|
|
5.20.
|
Insurance
|
25
|
|
|
5.21.
|
Permits
|
25
|
|
|
5.22.
|
Related
Party Transactions
|
25
|
|
|
5.23.
|
Brokerage
|
25
|
|
|
5.24.
|
Public
Filings
|
25
|
|
|
SECTION
6. PRE-CLOSING COVENANTS
|
26
|
||
|
6.1.
|
Access
and Investigation
|
26
|
|
|
6.2.
|
Operation
of the Businesses
|
26
|
|
|
6.3.
|
No
Inaccuracy or Breach of Representations, Warranties and
Covenants
|
26
|
|
|
6.4.
|
Takeover
Proposals
|
26
|
|
|
6.5.
|
MediSync
Disclosure Schedule
|
27
|
|
|
6.6.
|
Parent
Disclosure Schedules
|
27
|
|
|
SECTION
7. POST-CLOSING COVENANTS
|
27
|
||
|
7.1.
|
Cooperation;
Other Approvals, Filings and Consents
|
27
|
|
|
7.2.
|
Director
and Officer Liability and Indemnification
|
28
|
|
|
7.3.
|
Employee
Matters
|
28
|
|
|
SECTION
8. CONDITIONS TO CLOSING
|
29
|
||
|
8.1.
|
Conditions
to Obligation of Parent and Merger Sub
|
29
|
|
|
8.2.
|
Conditions
to Obligation of MediSync
|
31
|
|
|
SECTION
9. TERMINATION
|
33
|
||
|
9.1.
|
Termination
Events
|
33
|
|
|
9.2.
|
Effect
of Termination
|
33
|
|
|
SECTION
10. MISCELLANEOUS
|
33
|
||
|
10.1.
|
Press
Releases and Communication
|
33
|
|
|
10.2.
|
Expenses
|
33
|
|
|
10.3.
|
Notices
|
33
|
|
|
10.4.
|
Assignment
|
34
|
|
|
10.5.
|
Severability
|
34
|
|
|
10.6.
|
No
Strict Construction
|
35
|
|
|
10.7.
|
Amendment
and Waiver
|
35
|
|
|
10.8.
|
Complete
Agreement
|
35
|
|
|
10.9.
|
Counterparts
|
35
|
|
|
10.10.
|
No
Third-Party Beneficiaries
|
35
|
|
|
10.11.
|
Governing
Law; Jurisdiction; Waiver of Jury Trial
|
35
|
|
|
10.12.
|
Specific
Performance
|
36
|
|
|
Appendix
A
|
Definitions
|
|
|
Schedule
3.1(a)
|
Merger
Consideration Allocation – Common Stock Holders
|
|
|
Schedule
3.1(b)
|
Merger
Consideration Allocation – MediSync Notes Holders
|
|
|
Schedule
3.1(c)
|
Merger
Consideration Allocation – MediSync Indebtedness
|
|
|
Schedule
3.2
|
Merger
Consideration Allocation – MediSync Warrant Holders
|
|
|
Schedule
3.3
|
Merger
Consideration Allocation – MediSync Option Holders
|
|
|
Schedule
8.1(c)
|
MediSync
Consents
|
|
|
Schedule
8.2(c)
|
Parent/Merger
Sub Consents
|
|
|
Exhibit
A
|
Form
of Warrant
|
|
|
Exhibit
B
|
Form
of Option Agreement
|
|
|
Exhibit
C
|
Form
of Letter of Transmittal
|
|
|
Exhibit
D
|
Knowledge
Individuals – MediSync
|
|
|
Exhibit
E
|
Knowledge
Individuals – Parent/Merger
Subs
|
|
MediSync-Vyteris
Merger Agreement
|
|
MEDISYNC
|
||
|
MediSync
BioServices, Inc.
|
||
|
By:
|
/s/ Dubi Ehrlich
|
|
|
Name:
Dubi Ehrlich
|
||
|
Title:
President
|
||
|
PARENT
|
||
|
Vyteris,
Inc.
|
||
|
By:
|
/s/ Haro Hartounian
|
|
|
Name:
Haro Hartounian
|
||
|
Title:
Chief Executive Officer
|
||
|
MERGER SUB
|
||
|
VYHNSUB,
INC.
|
||
|
By:
|
/s/ Haro Hartounian
|
|
|
Name:
Haro Hartounian
|
||
|
Title:
President
|
||
|
Page
|
||
|
Agreement
|
1
|
|
|
Certificate
of Merger
|
2
|
|
|
Closing
|
2
|
|
|
Closing
Date
|
2
|
|
|
DGCL
|
2
|
|
|
Effective
Time
|
2
|
|
|
Environmental
Permits
|
14
|
|
|
Indemnified
Parties
|
28
|
|
|
Indemnified
Party
|
28
|
|
|
Information
Statement
|
32
|
|
|
Letter
of Transmittal
|
4
|
|
|
MediSync
Audited Financial Statements
|
7
|
|
|
MediSync
Certificates
|
4
|
|
|
MediSync
Competing Business
|
15
|
|
|
MediSync
Disclosure Schedules
|
5
|
|
|
MediSync
Documents
|
6
|
|
|
MediSync
Employees
|
11
|
|
|
MediSync
Financial Statements
|
7
|
|
|
MediSync
Interim Balance Sheet Date
|
7
|
|
|
MediSync
Interim Financial Statements
|
7
|
|
|
MediSync
Leased Property
|
8
|
|
|
MediSync
Material Contracts
|
9
|
|
|
MediSync
Plan
|
12
|
|
|
Merger
|
1
|
|
|
Merger
Sub
|
1
|
|
|
Parent
|
1
|
|
|
Parent
Audited Financial Statements
|
17
|
|
|
Parent
Competing Business
|
25
|
|
|
Parent
Disclosure Schedules
|
15
|
|
|
Parent
Documents
|
16
|
|
|
Parent
Employees
|
21
|
|
|
Parent
Financial Statements
|
17
|
|
|
Parent
Interim Balance Sheet Date
|
17
|
|
|
Parent
Interim Financial Statements
|
17
|
|
|
Parent
Leased Property
|
18
|
|
|
Parent
Material Contracts
|
19
|
|
|
Parent
Plan
|
22
|
|
|
Parent
Public Reports
|
25
|
|
|
Parent
Welfare Benefit Plans
|
29
|
|
|
Parties
|
1
|
|
|
Party
|
1
|
|
|
Surviving
Corporation
|
2
|
|
|
Surviving
Corporation By-laws
|
3
|
|
|
Surviving
Corporation Certificate
|
3
|
|
Holder
|
Shares of MediSync
Common Stock Held
Immediately Prior to
Closing
|
Shares of
Parent
Common Stock
Issuable at Closing
|
||||||
|
Ehrlich,
Dov (SMC Ventures Inc.)
|
481,550 | 2,407,750 | ||||||
|
Kay,
Jack
|
28,875 | 144,375 | ||||||
|
Bauer,
Eugene A. M.D.
|
71,881 | 359,405 | ||||||
|
Brukardt,
Gary
|
114,604 | 573,020 | ||||||
|
Burleson,
Gene
|
132,966 | 664,830 | ||||||
|
Abeles,
John (Northlea Partners)
|
342,515 | 1,712,575 | ||||||
|
Kanter,
Joel (Windy City)
|
245,098 | 1,225,490 | ||||||
|
Bonanno
Family Partnership, LLLP
|
150,000 | 750,000 | ||||||
|
Samuel
Del Presto
|
25,000 | 125,000 | ||||||
|
O.T.
Finance, SA
|
25,000 | 125,000 | ||||||
|
Kanter
Family Foundation
|
55,226 | 276,130 | ||||||
|
Carl
J. Domino
|
25,000 | 125,000 | ||||||
|
Richard
Nuestader
|
75,000 | 375,000 | ||||||
|
Ron
Eller
|
25,000 | 125,000 | ||||||
|
Mark
Abrams
|
25,000 | 125,000 | ||||||
|
Steven
H. Deutsch
|
125,000 | 625,000 | ||||||
|
Michael
J. Pierce
|
25,000 | 125,000 | ||||||
|
Reed
Oslan
|
20,000 | 100,000 | ||||||
|
Richard
M. Spitalny
|
15,000 | 75,000 | ||||||
|
Stanley
& Miriam Greenberg
|
25,000 | 125,000 | ||||||
|
CIBC
Trust Company (Bahamas) Limited
|
135,809 | 679,045 | ||||||
|
Spencer
Trask Breakthrough Partners, LLC
|
550,000 | 2,750,000 | ||||||
|
Chicago
Investments, Inc.
|
36,281 | 181,405 | ||||||
|
Elliot
Braun
|
25,000 | 125,000 | ||||||
|
Craig
Whited
|
50,000 | 250,000 | ||||||
|
R&R
Ventures, LLC
|
25,000 | 125,000 | ||||||
|
Kevin
Carnahan
|
100,000 | 500,000 | ||||||
|
Joe
N. and Jamie W. Behrendt Revocable Trust dated October 30,
1996
|
25,000 | 125,000 | ||||||
|
Robert
Burkhardt
|
10,000 | 50,000 | ||||||
|
Total
|
2,989,805 | 14,949,025 | ||||||
|
Holder
|
Principal and Interest
Outstanding on
MediSync Promissory
Notes Immediately Prior
to Closing*
|
Shares of
Parent
Common Stock
Issuable at Closing
|
||||||
|
Ehrlich,
Dov (SMC Ventures Inc.)
|
$ | 25,517 | 127,586 | |||||
|
Bauer,
Eugene A. M.D.
|
41,033 | 205,167 | ||||||
|
Brukardt,
Gary
|
28,205 | 141,027 | ||||||
|
Burleson,
Gene
|
47,288 | 236,442 | ||||||
|
Abeles,
John (Northlea Partners)
|
179,322 | 896,612 | ||||||
|
Kanter,
Joel (Windy City)
|
88,523 | 442,613 | ||||||
|
Bonanno
Family Partnership, LLLP
|
180,756 | 903,778 | ||||||
|
Samuel
Del Presto
|
28,267 | 141,336 | ||||||
|
O.T.
Finance, SA
|
28,267 | 141,336 | ||||||
|
Kanter
Family Foundation
|
59,603 | 298,016 | ||||||
|
Carl
J. Domino
|
28,205 | 141,027 | ||||||
|
Richard
Nuestader
|
90,316 | 451,581 | ||||||
|
Ron
Eller
|
28,205 | 141,027 | ||||||
|
Mark
Abrams
|
28,205 | 141,027 | ||||||
|
Steven
H. Deutsch
|
151,026 | 755,132 | ||||||
|
Michael
J. Pierce
|
28,205 | 141,027 | ||||||
|
Reed
Oslan
|
22,564 | 112,822 | ||||||
|
Richard
M. Spitalny
|
17,923 | 89,616 | ||||||
|
Stanley
& Miriam Greenberg
|
28,205 | 141,027 | ||||||
|
CIBC
Trust Company (Bahamas) Limited
|
147,732 | 738,660 | ||||||
|
Chicago
Investments, Inc.
|
37,615 | 188,077 | ||||||
|
Elliot
Braun
|
31,055 | 155,277 | ||||||
|
Craig
Whited
|
62,111 | 310,553 | ||||||
|
R&R
Ventures, LLC
|
30,705 | 153,526 | ||||||
|
Kevin
Carnahan
|
122,821 | 614,104 | ||||||
|
Joe
N. and Jamie W. Behrendt Revocable Trust dated October 30,
1996
|
30,705 | 153,526 | ||||||
|
Robert
Burkhardt
|
12,282 | 61,410 | ||||||
|
Total
|
$ | 1,604,667 | 8,023,333 | |||||
|
Holder
|
Indebtedness
Outstanding
Immediately Prior to
Closing
|
Shares of
Parent
Common Stock
Issuable at Closing
|
||||||
|
Kanter,
Joel (Windy City)
|
$ | 361,779 | 1,808,895 | |||||
|
Chicago
Investments, Inc.
|
50,000 | 250,000 | ||||||
|
Total
|
$ | 411,779 | 2,058,895 | |||||
|
Holder
|
Warrants to Purchase
Shares of MediSync
Common Stock Held
Immediately Prior to
Closing
|
Warrants to Purchase
Shares of Parent
Common Stock
Issuable at Closing
|
||||||
|
Spencer
Trask Ventures
|
418,000 |
2,090,000
($0.20 exercise price)
|
||||||
|
Total
|
418,000 | 2,090,000 | ||||||
|
Holder
|
Options to Purchase
Shares of MediSync
Common Stock Held
Immediately Prior to
Closing
|
Options to Purchase
Shares of Parent
Common Stock
Issuable at Closing
|
||||||
|
Ehrlich,
Dov
|
134,700 | 673,500 | ||||||
|
Bauer,
Eugene A. M.D.
|
67,350 | 336,750 | ||||||
|
Total
|
202,050 | 1,010,250 | ||||||
|
1.
|
Consent of the holders of
MediSync Common Stock set forth in Schedule
3.1(a) to the
Merger.
|
|
2.
|
Consent of the holders of the
MediSync Notes set forth in Schedule
3.13.1(b) to the
conversion of the applicable MediSync Notes as set forth
herein.
|
|
3.
|
Consent of the holders of the
MediSync outstanding indebtedness set forth in Schedule
3.13.1(c) to the
conversion of the applicable indebtedness as set forth
herein.
|
|
4.
|
Consent of the holders of the
MediSync Warrants set forth in Schedule
3.2 to the
cancellation of the applicable MediSync Warrants as set forth
herein.
|
|
5.
|
Consent of the holders of the
MediSync Options set forth in Schedule
3.3 to the
cancellation of the applicable MediSync Options as set forth
herein.
|
|
1.
|
Consent of the holders of Parent
Common Stock holding a majority of the Common Stock of Parent not held by
interested parties in the transaction and consent of Parent as the sole
stockholder of Merger Sub.
|
|
·
|
Women’s health, such as
infertility,
|
|
·
|
Migraine
treatment,
|
|
·
|
Pain management,
and
|
|
·
|
Metabolic diseases, such as
diabetes and
osteoporosis.
|
|
|
·
|
finalizing the design of the
system;
|
|
|
·
|
seeing how deep the numbness
goes;
|
|
|
·
|
looking at the amount of drug
that gets into the blood
stream;
|
|
|
·
|
determining if it matters where
you place the patch on the
body;
|
|
|
·
|
making sure the lidocaine that is
administered does not contaminate the blood samples that are drawn from
the site where the patch was on the skin;
and
|
|
|
·
|
comparing the performance of the
patch to EMLA lidocaine
cream.
|
|
|
·
|
Conventional
Oral Method.
Conventional, oral drug dosage forms, such as pills and capsules, are the
most common types of drug delivery. Oral drug delivery methods are
easy to administer, but their efficacy can be limited because drugs must
first pass through the digestive system and liver before being absorbed
into the bloodstream. Therefore, orally delivered drug dosages must
be large to overcome the degradation that occurs in the gastrointestinal
tract and liver. As a result, conventional oral dosage forms often
produce higher initial drug levels than are required to achieve the
desired therapeutic effects, thereby increasing the risk of side effects,
some of which can be serious. Also, it is difficult to maintain
therapeutically optimal drug levels using oral drug delivery
methods. Further, oral drug delivery methods can require patients to
follow inconvenient dosing routines, which may diminish patient compliance
with self-medication
schedules.
|
|
|
·
|
Injection
Methods.
Injectable drug dosage forms generally provide rapid onset of therapeutic
action and offer many of the same advantages as conventional oral drug
dosage methods. Injectable drug delivery methods use needles,
raising the possibility of needle-stick injuries, as well as the risk of
infection to the caregiver and the patient. The use of needles also
increases patient anxiety due to the pain of
injection.
|
|
|
·
|
Sustained
release oral dosage forms are designed to release the
active ingredients of the drug into the body at either a predetermined
point in time or at a predetermined rate over an extended period of time,
generally do not work fast and may be partially destroyed by the liver and
stomach before they get into the blood
stream.
|
|
|
·
|
Passive
transdermal patches allow absorption of drugs through
the skin and generally provide a convenient method of administering drugs
at a steady rate over an extended period of time, but onset of action may
take hours after application, and absorption of the drug may continue for
hours after the patch is removed, which can increase side effects.
Additionally, because human skin is an effective barrier, most drug
formulations will not passively permeate the skin in therapeutic
quantities.
|
|
|
·
|
Sustained
release injectable preparations allow conventional
injectable drugs to be incorporated into a biodegradable material that is
then injected and absorbed slowly into the surrounding tissue. These
preparations reduce the frequency of injections by creating a small
“depot” of the drug beneath the skin that is slowly absorbed by the body,
thus increasing the interval between injections. They can turn a
conventional once-a-day injection into a once weekly or even longer
regimen.
|
|
|
·
|
Continuous
infusion pumps are
small implantable or externally-worn battery-powered pumps that introduce
drugs directly into the body, using a needle or catheter inserted into
tissue just below the skin or directly into the blood stream or spinal
space. They use conventional drugs, and provide rapid onset of
action as well as sustained or programmed delivery of medication.
These are costly, complex electromechanical devices reserved mostly for
treatment of chronic conditions such as the delivery of insulin for
certain diabetes patients and for chronic intractable pain management for
the treatment of certain forms of
spasticity.
|
|
|
·
|
Pulmonary,
nasal and transmucosal methods are designed to provide fast
action or to deliver drugs that are destroyed by the gastro-intestinal
tract. Variations in a user's respiratory tract, often brought on by
everyday occurrences such as a cold, infection or even changes in climate,
can markedly affect the amount of drug inhaled from each
spray.
|
|
|
·
|
Jet injection
drug delivery technology uses stored mechanical energy
from either a spring or compressed gas cylinder to ballistically deliver a
liquid or powder through the skin without a needle. Liquid jet
injection has been used for many years with minimal success. A new
technology allows the administration of small amounts of drugs in dry
powder form through the skin using a specially engineered device, which
propels the drug using a high-powered jet of helium gas. The gas
accelerates the dry drug particles, enabling penetration of the
skin.
|
|
|
·
|
enabling more efficient electrode
designs;
|
|
|
·
|
drug formulations that enhance
iontophoresis;
|
|
|
·
|
specific transdermal patch
features allowing convenient use and low manufacturing
cost;
|
|
|
·
|
electronic circuitry and program
algorithms improving the safety and control of medication delivery;
and
|
|
|
·
|
ability to deliver specific
classes of molecules not previously
possible.
|
|
|
·
|
preclinical development, during
which initial laboratory development and in vitro and in vivo testing
takes place;
|
|
|
·
|
submission to the FDA of an
investigational new drug application (IND) for the commencement of
clinical studies;
|
|
|
·
|
adequate and well-controlled
human clinical trials — Phase I, II and III studies —to establish the
safety and efficacy of the
product;
|
|
|
·
|
submission of an NDA to the FDA
requesting clearance to market the product and comparable filings to
regulatory agencies outside the United States if the product is to be
marketed outside of the United States;
and
|
|
|
·
|
clearance from the FDA — and
foreign regulatory authorities, if applicable — must be obtained before
the product can be marketed.
|
|
High
|
Low
|
|||||||
|
Year
Ending December 31, 2010
|
||||||||
|
First
Quarter
|
$ | 0.79 | $ | 0.25 | ||||
|
Second
Quarter
|
0.75 | 0.25 | ||||||
|
Third
Quarter
|
0.75 | 0.25 | ||||||
|
Year
Ended December 31, 2009:
|
||||||||
|
First
Quarter
|
$ | 0.28 | $ | 0.10 | ||||
|
Second
Quarter
|
0.28 | 0.10 | ||||||
|
Third
Quarter
|
0.75 | 0.11 | ||||||
|
Fourth
Quarter
|
1.40 | 0.26 | ||||||
|
Year
Ended December 31, 2008:
|
||||||||
|
First
Quarter
|
$ | 10.05 | $ | 2.25 | ||||
|
Second
Quarter
|
4.80 | 1.65 | ||||||
|
Third
Quarter
|
2.00 | 0.35 | ||||||
|
Fourth
Quarter
|
0.87 | 0.20 | ||||||
|
Plan Category
|
(a)
Number of Securities to
be Issued Upon Exercise
of Outstanding Options,
Warrants and Rights
|
(b)
Weighted-Average
Exercise Price of
Outstanding Options,
Warrants
and Rights
|
(c)
Number of Securities Remaining
Available for Future Issuance
Under Equity Compensation Plans
(Excluding Securities
Reflected in Column (a))
|
|||||||||
|
Equity
Compensation Plans Approved
by Stockholders:
|
||||||||||||
|
Vyteris
Holdings 2005 Stock Option Plan
|
193,460 | $ | 2.11 | - | ||||||||
|
Equity
Compensation Plans Not Approved by Stockholders:
|
||||||||||||
|
Vyteris
Holdings 2005 Stock Option Plan (1)
|
2,834,608 | $ | 2.11 | 2,423,424 | ||||||||
|
Outside
Director Stock Incentive Plan (1)
|
1,265,374 | $ | 0.92 | 1,317,959 | ||||||||
|
Total
|
4,293,442 | $ | 1.76 | 3,741,383 | ||||||||
|
(1)
|
For further information regarding
the Vyteris Stock Option Plan and the Outside Director Stock Incentive
Plan, see Note 14 to the consolidated financial statements in Item 8 of
this Annual Report on Form
10-K.
|
|
Report
of Independent Registered Public Accounting Firm
|
B-16
|
|
|
Consolidated
Balance Sheets as of December 31, 2009 and 2008
|
B-17
|
|
|
Consolidated
Statements of Operations for the years ended December 31, 2009, 2008 and
2007
|
B-18
|
|
|
Consolidated
Statements of Stockholders’ Equity (Deficit) for the years ended
December 31, 2009, 2008 and 2007
|
B-19
|
|
|
Consolidated
Statements of Cash Flows for the years ended December 31, 2009, 2008 and
2007
|
B-20
|
|
|
Notes
to Consolidated Financial Statements
|
B-22
|
|
/s/ Amper, Politziner & Mattia,
LLP
|
|
December 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
ASSETS
|
||||||||
|
Current
assets:
|
||||||||
|
Cash
and cash equivalents
|
$ | 2,173,039 | $ | 222,821 | ||||
|
Other
current assets
|
120,527 | 131,737 | ||||||
|
Restricted
cash
|
— | 16,245 | ||||||
|
Total
current assets
|
2,293,566 | 370,803 | ||||||
|
Restricted
cash, less current portion
|
— | 108,000 | ||||||
|
Property
and equipment, net
|
114,024 | 298,983 | ||||||
|
Other
assets
|
225,356 | 276,026 | ||||||
|
TOTAL
ASSETS
|
$ | 2,632,946 | $ | 1,053,812 | ||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$ | 2,432,976 | $ | 2,798,923 | ||||
|
Senior
secured convertible debentures due to Ferring
|
— | 2,750,000 | ||||||
|
Accrued
registration rights penalty
|
— | 2,402,029 | ||||||
|
Interest
payable and accrued expenses due to a related party
|
111,560 | 2,578,282 | ||||||
|
Revaluation
of warrant liability
|
2,634,487 | — | ||||||
|
Accrued
expenses, deferred revenue and other
|
3,135,013 | 1,379,724 | ||||||
|
Total
current liabilities
|
8,314,036 | 11,908,958 | ||||||
|
Promissory
note due to a related party
|
1,750,000 | — | ||||||
|
Working
capital facility due to a related party
|
— | 2,850,000 | ||||||
|
Subordinated
convertible notes due to a related party, net of discount
|
— | 5,366,550 | ||||||
|
Deferred
revenue and other
|
821,237 | 28,605 | ||||||
|
Accrued
facilities realignment costs, less current portion
|
— | 2,099,758 | ||||||
|
Convertible
note
|
500,000 | — | ||||||
|
Preferred
stock, 3,333,333 shares authorized:
|
||||||||
|
Series
B convertible, mandatorily redeemable preferred stock; 500,000 shares
issued and outstanding on December 31, 2008; liquidation preference
$10,050,000 at December 31, 2008
|
— | 10,050,000 | ||||||
|
Total
liabilities
|
11,385,273 | 32,303,871 | ||||||
|
Commitments
and contingencies
|
||||||||
|
Stockholders’
equity (deficit):
|
||||||||
|
Common
stock, par value $.015 per share; 400,000,000 and 33,333,333 shares
authorized, at December 31, 2009 and December 31, 2008, respectively,
62,398,817 and 7,282,802 shares issued and outstanding at
December 31, 2009 and December 31, 2008, respectively
|
935,982 | 109,242 | ||||||
|
Additional
paid-in capital
|
204,642,912 | 149,031,557 | ||||||
|
Accumulated
deficit
|
(214,331,221 | ) | (180,390,858 | ) | ||||
|
Total
stockholders’ equity (deficit)
|
(8,752,327 | ) | (31,250,059 | ) | ||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$ | 2,632,946 | $ | 1,053,812 | ||||
|
Years Ended December 31,
|
||||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Revenues:
|
||||||||||||
|
Product
development revenue
|
$ | 1,913,080 | $ | 2,821,098 | $ | 2,634,540 | ||||||
|
Licensing
and other revenue
|
2,647,629 | 329,298 | 149,547 | |||||||||
|
Total
revenues
|
4,560,709 | 3,150,396 | 2,784,087 | |||||||||
|
Costs
and expenses:
|
||||||||||||
|
Cost
of sales
|
— | 103,490 | 1,490,847 | |||||||||
|
Research
and development
|
2,895,691 | 6,269,636 | 8,956,962 | |||||||||
|
General
and administrative including (credit) for reversal of performance –
based stock option grants of ($6.1) million in 2008
|
2,796,763 | (125,155 | ) | 15,369,243 | ||||||||
|
Sales
and marketing
|
— | 175,507 | 6,251,362 | |||||||||
|
Facility
realignment and impairment of fixed assets
|
177,831 | 2,565,434 | 82,637 | |||||||||
|
Non-cash
warrant expense – financial consultants
|
— | 81,592 | 17,115,000 | |||||||||
|
Registration
rights penalty
|
215,988 | 260,897 | 260,184 | |||||||||
|
Total
costs and expenses
|
6,086,273 | 9,331,401 | 49,526,235 | |||||||||
|
Loss
from operations
|
(1,525,564 | ) | (6,181,005 | ) | (46,742,148 | ) | ||||||
|
Interest
(income) expense:
|
||||||||||||
|
Interest
income
|
(552 | ) | (42,984 | ) | (210,359 | ) | ||||||
|
Interest
expense to related parties
|
1,451,728 | 1,570,054 | 2,208,557 | |||||||||
|
Interest
expense
|
169,610 | 377,942 | 1,790,197 | |||||||||
|
Interest
expense, net
|
1,620,786 | 1,905,012 | 3,788,395 | |||||||||
|
Other
(income) expenses:
|
||||||||||||
|
Gain
on settlement of lease obligations
|
(1,953,977 | ) | — | — | ||||||||
|
Gain
on settlement of registration rights penalty
|
(1,385,017 | ) | — | — | ||||||||
|
Non-cash
debt extinguishment
|
35,909,507 | — | 6,724,523 | |||||||||
|
Non-cash
modification of redeemable preferred stock terms
|
— | — | 3,680,000 | |||||||||
|
Revaluation
of warrant liability
|
294,668 | — | 10,341,408 | |||||||||
|
Total
other expenses
|
32,865,181 | — | 20,745,931 | |||||||||
|
Loss
before benefit from state income taxes
|
(36,011,531 | ) | (8,086,017 | ) | (71,276,474 | ) | ||||||
|
Sale
of State of New Jersey net operating losses
|
2,071,168 | 61,777 | 463,786 | |||||||||
|
Net
loss
|
$ | (33,940,363 | ) | $ | (8,024,240 | ) | $ | (70,812,688 | ) | |||
|
Net
loss per common share:
|
||||||||||||
|
Basic
and diluted
|
$ | (3.77 | ) | $ | (1.14 | ) | $ | (13.28 | ) | |||
|
Weighted
average number of common shares:
|
||||||||||||
|
Basic
and diluted
|
9,002,816 | 7,032,288 | 5,333,834 | |||||||||
|
Additional
|
Total
|
|||||||||||||||||||
|
Common Stock
|
Paid-in
|
Accumulated
|
Stockholders’
|
|||||||||||||||||
|
Shares
|
Amount
|
Capital
|
Deficit
|
Equity (Deficit)
|
||||||||||||||||
|
Balance
at January 1, 2007
|
4,218,997 | $ | 63,285 | $ | 70,922,366 | $ | (101,553,930 | ) | $ | (30,568,279 | ) | |||||||||
|
Non-cash
stock-based compensation expense
|
– | – | 8,166,739 | – | 8,166,739 | |||||||||||||||
|
Exercise
of stock options
|
20,044 | 301 | 501,227 | – | 501,528 | |||||||||||||||
|
Issuance
of restricted shares under outside director compensation
plan
|
5,179 | 78 | 57,522 | – | 57,600 | |||||||||||||||
|
Issuance
of common stock for capital raised
|
1,420,488 | 21,307 | 22,856,692 | – | 22,877,999 | |||||||||||||||
|
Disbursements
related to issuance costs of common stock raise and
warrants
|
– | – | (2,417,512 | ) | – | (2,417,512 | ) | |||||||||||||
|
Issuance
of warrants associated with working capital facility
|
– | – | 736,287 | – | 736,287 | |||||||||||||||
|
Issuance
of common stock pursuant to conversion of senior secured convertible
debentures
|
256,989 | 3,855 | 959,852 | – | 963,707 | |||||||||||||||
|
Transfer
of warrant liability to equity upon shareholder approval of
sufficient authorized shares
|
– | – | 19,334,776 | – | 19,334,776 | |||||||||||||||
|
Cashless
exercise of warrants
|
3,696 | 55 | (55 | ) | – | – | ||||||||||||||
|
Issuance
of warrants to advisors
|
– | – | 543,750 | – | 543,750 | |||||||||||||||
|
Issuance
of warrants to financial consultants
|
– | – | 17,115,000 | – | 17,115,000 | |||||||||||||||
|
Charge
resulting from non-cash debt extinguishment, net of unamortized
discount
|
– | – | 6,696,058 | – | 6,696,058 | |||||||||||||||
|
Charge
resulting from non-cash modification of redeemable preferred stock
terms
|
– | – | 3,680,000 | – | 3,680,000 | |||||||||||||||
|
Net
loss
|
– | – | – | (70,812,688 | ) | (70,812,688 | ) | |||||||||||||
|
Balance
at December 31, 2007
|
5,925,393 | 88,881 | 149,152,702 | (172,366,618 | ) | (23,125,035 | ) | |||||||||||||
|
Non-cash
stock based compensation expense (credits)
|
– | – | (4,051,359 | ) | – | (4,051,359 | ) | |||||||||||||
|
Issuance
of common stock for capital raised, net
|
660,000 | 9,900 | 1,790,100 | – | 1,800,000 | |||||||||||||||
|
Exercise
of warrants
|
611,895 | 9,178 | 1,826,505 | – | 1,835,683 | |||||||||||||||
|
Non-cash
warrant expense – financial consultants
|
– | – | 81,592 | – | 81,592 | |||||||||||||||
|
Issuance
of warrants for services rendered
|
– | – | 184,000 | – | 184,000 | |||||||||||||||
|
Issuance
of common stock for services rendered
|
85,000 | 1,275 | 48,025 | – | 49,300 | |||||||||||||||
|
Adjustment
to common stock related to reverse stock split
|
514 | 8 | (8 | ) | – | – | ||||||||||||||
|
Net
loss
|
– | – | – | (8,024,240 | ) | (8,024,240 | ) | |||||||||||||
|
Balance
at December 31, 2008
|
7,282,802 | 109,242 | 149,031,557 | (180,390,858 | ) | (31,250,059 | ) | |||||||||||||
|
Non-cash
stock based compensation expense, net
|
– | – | 639,007 | – | 639,007 | |||||||||||||||
|
Issuance
of common stock for services rendered
|
9,000 | 135 | 1,260 | – | 1,395 | |||||||||||||||
|
Issuance
of common stock upon exercise of warrants issued For settlement with
landlord
|
80,000 | 1,200 | 6,800 | – | 8,000 | |||||||||||||||
|
Issuance
of warrants
|
– | – | 154,200 | – | 154,200 | |||||||||||||||
|
Issuance
of common stock for capital raised, net
|
3,000,000 | 45,000 | 477,000 | – | 522,000 | |||||||||||||||
|
Issuance
of common stock and warrants upon settlement of registration rights
penalty
|
1,250,000 | 18,750 | 1,214,250 | – | 1,233,000 | |||||||||||||||
|
Issuance
of common stock pursuant to conversion of senior secured convertible
debentures and preferred stock due to a related party
|
50,777,015 | 761,655 | 19,549,151 | – | 20,310,806 | |||||||||||||||
|
Reclassification
of the fair value of warrants from an equity instrument to a liability
instrument
|
– | – | (2,339,820 | ) | – | (2,339,820 | ) | |||||||||||||
|
Charge
resulting from non-cash debt extinguishment
|
– | – | 35,909,507 | – | 35,909,507 | |||||||||||||||
|
Net
loss
|
– | – | – | (33,940,363 | ) | (33,940,363 | ) | |||||||||||||
|
Balance
at December 31, 2009
|
62,398,817 | $ | 935,982 | $ | 204,642,912 | $ | (214,331,221 | ) | $ | (8,752,327 | ) | |||||||||
|
Years Ended December 31,
|
||||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
|
Net
loss
|
$ | (33,940,363 | ) | $ | (8,024,240 | ) | $ | (70,812,688 | ) | |||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
|
Depreciation
and amortization
|
175,421 | 286,300 | 386,865 | |||||||||
|
Stock
based compensation charges
|
639,007 | (4,051,359 | ) | 8,166,739 | ||||||||
|
Amortization
of senior secured convertible debentures discount
|
— | — | 753,659 | |||||||||
|
Gain
on settlement of lease obligations
|
(1,953,977 | ) | — | — | ||||||||
|
Amortization
of discount on senior secured promissory note
|
— | 231,403 | 231,547 | |||||||||
|
Gain
on settlement of registration rights penalty
|
(1,385,017 | ) | — | — | ||||||||
|
Accrued
registration rights penalty
|
215,988 | 260,897 | 260,184 | |||||||||
|
Non-cash
warrant expense – financial consultants
|
— | 81,592 | 17,115,000 | |||||||||
|
Non-cash
debt extinguishment
|
35,909,507 | — | 6,724,523 | |||||||||
|
Non-cash
modification of redeemable preferred stock
|
— | — | 3,680,000 | |||||||||
|
Inventory
reserves
|
— | 94,890 | 1,431,411 | |||||||||
|
Impairment
of fixed assets and accrued facilities realignment costs
|
— | 2,565,434 | 82,638 | |||||||||
|
Revaluation
of warrant liability
|
294,668 | — | 10,341,408 | |||||||||
|
Warrants
issued for working capital facility
|
— | — | 736,287 | |||||||||
|
Issuance
of warrants to advisor and other service providers
|
— | 184,000 | 543,750 | |||||||||
|
Other
|
227,689 | (209,851 | ) | (60,745 | ) | |||||||
|
Change
in operating assets and liabilities:
|
||||||||||||
|
Accounts
receivable
|
2,559 | 4,698 | 81,474 | |||||||||
|
Inventory
|
— | (94,890 | ) | (1,428,037 | ) | |||||||
|
Prepaid
expenses and other assets
|
59,320 | 117,341 | 65,165 | |||||||||
|
Accounts
payable
|
(225,964 | ) | 901,564 | (941,600 | ) | |||||||
|
Accrued
expenses and other liabilities
|
2,008,587 | (1,257,940 | ) | (425,464 | ) | |||||||
|
Recognition
of deferred revenue
|
(2,625,783 | ) | — | — | ||||||||
|
Interest
payable and accrued expenses to related parties
|
1,577,534 | 1,356,763 | 1,488,242 | |||||||||
|
Net
cash provided by (used in) operating activities
|
979,176 | (7,553,398 | ) | (21,579,642 | ) | |||||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
|
Changes
in restricted cash, net
|
— | 166,182 | 100,566 | |||||||||
|
Proceeds
from the sale of property and equipment
|
124,245 | 9,800 | — | |||||||||
|
Purchase
of equipment
|
(1,926 | ) | (4,695 | ) | (222,200 | ) | ||||||
|
Net
cash provided by (used in) investing activities
|
122,319 | 171,287 | (121,634 | ) | ||||||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
|
Net
proceeds from placement of common stock and warrants
|
522,000 | 1,800,000 | 20,530,759 | |||||||||
|
Proceeds
from exercise of options and warrants
|
8,000 | 1,835,683 | 501,528 | |||||||||
|
Net
proceeds from issuance of secured promissory notes to a related
party
|
— | — | 350,000 | |||||||||
|
Net
proceeds from senior secured convertible debentures-
Ferring
|
— | 2,750,000 | — | |||||||||
|
Repayment
of senior secured convertible promissory note
|
(250,000 | ) | (475,000 | ) | — | |||||||
|
Net
proceeds from sale of manufacturing equipment
|
568,723 | — | — | |||||||||
|
Other
|
— | (22,422 | ) | (136,046 | ) | |||||||
|
Net
cash provided by financing activities
|
848,723 | 5,888,261 | 21,246,241 | |||||||||
|
Net
increase (decrease) increase in cash and cash equivalents
|
1,950,218 | (1,493,850 | ) | (455,035 | ) | |||||||
|
Cash
and cash equivalents at beginning of the year
|
222,821 | 1,716,671 | 2,171,706 | |||||||||
|
Cash
and cash equivalents at end of the year
|
$ | 2,173,039 | $ | 222,821 | $ | 1,716,671 | ||||||
|
|
Years Ended December 31,
|
|||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||||||||
|
Interest
paid
|
$ | 181,559 | $ | 51,859 | $ | 38,346 | ||||||
|
Issuance
of warrants in connection with private placements of common
stock
|
— | 4,761,000 | 15,154,645 | |||||||||
|
Conversion
of senior secured convertible debentures into common stock
|
— | — | 963,707 | |||||||||
|
Reclassification
of the fair value of warrants from an equity instrument to a liability
instrument
|
2,339,820 | — | 19,334,776 | |||||||||
|
Issuance
of warrants
|
154,200 | — | — | |||||||||
|
Settlement
of registration rights penalty upon issuance of common stock and warrants
to shareholders
|
1,233,000 | — | — | |||||||||
|
Conversion
of senior secured convertible debentures and preferred stock due to a
related party
|
20,310,806 | — | — | |||||||||
|
Cashless
exercise of warrants for common stock
|
$ | — | $ | — | $ | 55 | ||||||
|
Manufacturing
and laboratory equipment
|
5
years
|
|
Furniture
and fixtures
|
5
years
|
|
Office
equipment
|
3
years
|
|
Leasehold
improvements
|
4 – 10
years
|
|
Software
|
3
years
|
|
3.
|
Restructuring
|
|
4.
|
Inventories,
net
|
|
December 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
Raw
materials
|
$ | 837,803 | $ | 1,358,388 | ||||
|
Work
in process
|
106,419 | 106,456 | ||||||
|
Finished
goods
|
188,674 | 294,169 | ||||||
|
Inventory
|
1,132,896 | 1,759,013 | ||||||
|
Excess
and obsolete inventory
|
(1,132,896 | ) | (1,759,013 | ) | ||||
|
Inventories,
net
|
$ | - | $ | - | ||||
|
5.
|
Property and Equipment,
net
|
|
December 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
Manufacturing
and laboratory equipment
|
$ | 1,875,930 | $ | 1,883,753 | ||||
|
Furniture
and fixtures
|
156,543 | 156,543 | ||||||
|
Office
equipment
|
345,423 | 363,142 | ||||||
|
Leasehold
improvements
|
367,818 | 367,818 | ||||||
|
Software
|
205,210 | 205,210 | ||||||
|
Property
and equipment
|
2,950,924 | 2,976,466 | ||||||
|
Less: Accumulated
depreciation and amortization
|
(2,836,901 | ) | (2,677,483 | ) | ||||
|
Property
and equipment, net
|
$ | 114,024 | $ | 298,983 | ||||
|
6.
|
Related Party indebtedness owed
to STSG and Series B Convertible, Mandatorily Redeemable Preferred
Stock
|
|
December 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
Principal
Amounts Outstanding
|
||||||||
|
January
2006 Promissory Note (1)(5)
|
$ | - | $ | 250,000 | ||||
|
2006
Promissory Notes (2)(5)
|
- | 5,116,550 | ||||||
|
Working
Capital Facility (3)(6)
|
- | 2,850,000 | ||||||
|
Series
B Preferred Stock (4)(5)
|
- | 10,050,000 | ||||||
|
2009
Promissory Note
(7)
|
1,750,000 | - | ||||||
|
Interest
Payable
|
||||||||
|
January
2006 Promissory Note (1)(5)
|
$ | - | $ | 93,090 | ||||
|
2006
Promissory Notes (2)(5)
|
- | 1,878,267 | ||||||
|
Working
Capital Facility (3)(6)
|
- | 535,339 | ||||||
|
Series
B Preferred Stock (4)(5)
|
- | - | ||||||
|
2009
Promissory Note (7)
|
2,014 | - | ||||||
|
December 31,
|
||||||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Interest Expense
|
||||||||||||
|
January
2006 Promissory Note
(1)(5)
|
$ | 32,319 | $ | 3,042 | $ | 250,000 | ||||||
|
2006
Promissory Notes (2)(5)
|
661,456 | 676,237 | 674,390 | |||||||||
|
Working
Capital Facility (3)(6)
|
255,075 | 260,775 | 888,762 | |||||||||
|
Series
B Preferred Stock
(4)(5)
|
588,710 | 600,000 | 600,000 | |||||||||
|
2009
Promissory Note (7)
|
2,014 | - | - | |||||||||
|
|
(1)
|
On January 31, 2006, STSG, a
related party, provided the Company with a loan in the form of 13.0%
subordinated convertible unsecured promissory note (the “January 2006
Promissory Note”).
|
|
|
(2)
|
In 2006, STSG provided the
Company with a loan in the form of 13.0% subordinated convertible
unsecured promissory notes (the “2006 Promissory
Notes”).
|
|
|
(3)
|
In September 2004, STSG agreed to
provide the Company with a working capital loan bearing interest at 9%, in
the form of secured demand promissory notes (the “Working Capital
Facility”).
|
|
|
(4)
|
Series B, Convertible,
Mandatorily Redeemable Preferred Stock (“Series B Preferred Stock”) was
issued to STSG and one other holder. The holders of the Series B Preferred
Stock were entitled to receive, ratably and payable quarterly, an annual
cash dividend of 8%. The stated value of the Series B Preferred Stock on
December 24, 2009 was $10.6
million.
|
|
|
(5)
|
The January 2006 Promissory Note,
the 2006 Promissory Notes and the Series B Preferred Stock were satisfied
in full on December 24, 2009. See footnote 7 below for a
discussion of the satisfaction of these
obligations.
|
|
|
(6)
|
On December 24, 2009, $0.9
million of the Working Capital Facility was satisfied in
full. The remaining $2.0 million was satisfied through the
issuance of the 2009 Promissory Note. See footnote 7 below for a
discussion of the satisfaction of this debt and the conversion into the
2009 Promissory Notes.
|
|
|
(7)
|
On December 24, 2009, the Company
entered into an Amendment to the Restructuring Agreement with
STSG.
|
|
|
1.
|
The principal amount of all
indebtedness and accrued and unpaid interest thereon and stated value of
the Series B Preferred Stock owed by the Company to STSG in excess of $2.0
million ($2.0 million amount is defined as the “Remaining Debt”) which
includes the January 2006 Promissory Note, the 2006 Promissory Notes, and
$0.9 million of Working Capital Facility were satisfied in full on
December 24, 2009. STSG converted $20.3 million of indebtedness and
accrued and unpaid interest and all issued and outstanding shares of
Series B Preferred Stock into 50,777,015 shares of the Company’s common
stock at a conversion price of $0.40 per
share.
|
|
|
2.
|
The Remaining Debt shall be
evidenced by a promissory note (“2009 Promissory Note”) with interest
accruing at the rate of 6% per year and with the same duration as the
first debt security to expire pursuant to a Qualified Financing, or if it
does not involve the sale of debt securities, December 24, 2012.
The 2009 Promissory Note is secured by a lien on the Company’s
assets, subordinate to the lien of any existing creditors that have a lien
senior to that of STSG and to any liens resulting from a Qualified
Financing.
|
|
|
3.
|
On December 28, 2009, the Company
paid to STSG $0.3 million to reduce the principal amount of the 2009
Promissory Note to $1.8 million as of December 31, 2009. Upon consummation
of a Qualified Financing with gross proceeds in excess of $3.0 million,
the Company is required to make another prepayment of $0.5 million. Upon a
Qualified Financing with gross proceeds in excess of $5.0 million, the
Company is required to make another prepayment of 50% of the net proceeds
from any Qualified Financing in excess of such
amounts.
|
|
7.
|
Accrued Registration Rights
Penalty
|
|
8.
|
Accrued Expenses, Deferred
Revenue and Other
|
|
December 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
Compensation,
accrued bonuses and benefits payable
|
$
|
413,743
|
$
|
330,715
|
||||
|
Continuous
motion patch machine costs and delivery
|
183,452
|
180,447
|
||||||
|
Reimbursement
of development costs to Ferring
|
1,386,919
|
97,178
|
||||||
|
Accrued
insurance costs
|
101,224
|
86,229
|
||||||
|
Accounting,
legal and consulting fees
|
334,095
|
96,690
|
||||||
|
Outside
services
|
371,243
|
6,504
|
||||||
|
Food
and drug administration fees
|
193,521
|
125,942
|
||||||
|
Facilities
realignment costs – current portion
|
-
|
251,411
|
||||||
|
Other
|
150,816
|
204,608
|
||||||
|
Accrued
expenses, deferred revenue and other
|
$
|
3,135,013
|
$
|
1,379,724
|
||||
|
9.
|
Agreements with
Ferring
|
|
|
a)
|
all licenses and other rights
granted to the Company shall, subject to the continued payment to Ferring
of certain royalty payments under of the Agreement, be converted to and
continue as exclusive, worldwide irrevocable, perpetual, sub-licensable
licenses to develop, make, have made, use, sell, offer to sell, lease,
distribute, import and export the
Product;
|
|
|
b)
|
all licenses and other rights
granted to Ferring under the Agreement shall be terminated as of the
effective date of the
termination;
|
|
|
c)
|
Ferring shall grant to the
Company an irrevocable, perpetual, exclusive, royalty-free, sub-licensable
license to practice certain intellectual property jointly developed under
the Agreement with respect to the iontophoretic administration of
infertility hormone;
|
|
|
d)
|
Ferring shall cease to use and
shall assign to the Company all of its rights, title and interest in and
to all clinical, technical and other relevant reports, records, data,
information and materials relating exclusively to the Product and all
regulatory filings (including any NDA, 510(k) or similar regulatory
filing) relating exclusively to the Product and provide the Company one
copy of each physical embodiment of the aforementioned items within thirty
(30) days after such termination;
and
|
|
|
e)
|
Ferring shall cease to use any
Know-How, Information or Materials arising under this Agreement to the
extent such Know-How, Information or Materials is owned by Ferring shall
promptly return to the Company all such
materials.
|
|
10.
|
Private Placements of Common
Stock and Warrants
|
|
11.
|
Related Party
Transactions
|
|
|
·
|
At December 31, 2009,
approximately $0.2 million is included in interest payable and accrued
expenses due to related party in the accompanying consolidated balance
sheets for amounts owed to
STSG.
|
|
|
·
|
On April 26, 2005, the Company
announced the appointment of Russell O. Potts, Ph.D. to its Board of
Directors. Dr. Potts has served the Company as a consultant in
drug delivery, glucose monitoring and medical devices since April
2003. The Company paid Dr. Potts
approximately $5,000, $21,000 and $87,000 for consulting
services and out of pocket expenses for the years ended December 31, 2009,
2008 and 2007, respectively.
|
|
|
·
|
On March 12, 2007, the Company
borrowed from Donald F. Farley, Chairman of the Board of Directors of the
Company at that time, $0.2 million at an interest rate of 10% per annum,
plus reimbursement to Mr. Farley for his closing costs. The Company repaid
this loan plus accrued interest in full on March 28, 2007. Additionally,
Mr. Farley was paid $40,000 for the year ended December 31, 2008 for the
performance of interim CEO
services.
|
|
|
·
|
At December 31, 2008,
approximately $0.05 million was paid for amounts owed to Arthur Courbanou
for additional services performed as Chairman of the Special Assessment
Committee.
|
|
12.
|
Income
Taxes
|
|
December 31,
|
||||||||
|
2009
|
2008
|
|||||||
|
Deferred tax assets:
|
||||||||
|
Net
operating tax loss carryforwards
|
$
|
38,781,000
|
$
|
40,737,000
|
||||
|
Research
and development tax credits
|
2,113,000
|
1,804,000
|
||||||
|
Amortization
of loan discount and accrued interest, related party
|
-
|
5,180,000
|
||||||
|
Stock
Warrants - Beneficial warrant conversion and revaluation
|
-
|
530,000
|
||||||
|
Fixed
asset depreciation
|
758,000
|
743,000
|
||||||
|
Inventory
reserves
|
453,000
|
703,000
|
||||||
|
Allowance
for asset impairments
|
-
|
1,987,000
|
||||||
|
Stock
based compensation
|
2,474,000
|
2,218,000
|
||||||
|
Registration
rights penalties
|
86,000
|
959,000
|
||||||
|
Non-cash
warrants – consultants
|
6,762,000
|
6,868,000
|
||||||
|
Revenue
Deferral
|
554,000
|
-
|
||||||
|
Issuance
of warrants to advisors
|
217,000
|
-
|
||||||
|
Issuance
of warrants on settlement of registration rights penalty
|
168,000
|
-
|
||||||
|
Other
|
255,000
|
528,000
|
||||||
|
Total
deferred tax asset
|
$
|
52,621,000
|
$
|
62,257,000
|
||||
|
Less
valuation allowance
|
(52,621,000
|
)
|
(62,257,000
|
)
|
||||
|
Net
deferred tax asset
|
$
|
—
|
$
|
—
|
||||
|
|
|
December 31,
|
|
|||||||||
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|||
|
Statutory
rate
|
(34
|
)%
|
(34
|
)%
|
(34
|
)%
|
||||||
|
State
income tax – sale of net operating losses
|
(6
|
)%
|
(1
|
)%
|
(1
|
)%
|
||||||
|
Research
and development credits
|
(0
|
)%
|
(2
|
)%
|
(1
|
)%
|
||||||
|
Change
in valuation allowance and other items
|
35
|
%
|
36
|
%
|
35
|
%
|
||||||
|
Benefit
for income tax
|
(5
|
)%
|
(1
|
)%
|
(1
|
)%
|
||||||
|
13.
|
Commitments and
Contingencies
|
|
|
|
Operating
Leases
|
|
|
|
Years
ended December 31,
|
||||
|
2010
|
$
|
407,088
|
||
|
2011
|
402,580
|
|||
|
2012
|
-
|
|||
|
2013
|
-
|
|||
|
2014
|
-
|
|||
|
Thereafter
|
-
|
|||
|
Total
minimum lease payments
|
$
|
809,668
|
||
|
Totals
|
||||
|
Balance
as of December 31, 2007
|
$
|
-
|
||
|
Facilities
realignment charge
|
2,350,600
|
|||
|
Deferred
rent adjustment
|
179,067
|
|||
|
Accretion
|
132,606
|
|||
|
Payments
|
(311,104
|
)
|
||
|
Balance
as of December 31, 2008
|
2,351,169
|
|||
|
Less
current portion included in accrued expenses, deferred revenue and
other
|
(251,411
|
)
|
||
|
Present
value of abandoned operating lease payments
|
$
|
2,099,758
|
||
|
14.
|
Stock Based Compensation Plans
and Employment Agreements
|
|
|
1.
|
Cash payments consist of a
$25,000 annual retainer, $5,000 annually for serving on a Board Committee,
$5,000 annually for acting as the Chairman of a Committee, and $15,000
annually for acting as Chairman of the
Board.
|
|
|
2.
|
Options with a fair market value
strike price and 10 year term consisting of a 3,334 initial option grant,
vesting quarterly over two years, at 417 per quarter and a 2,000 annual
option grant, vesting quarterly over one year, at 500 options per
quarter.
|
|
|
Number of
Shares
|
Exercise Price
Per Share
|
Weighted
Average
Exercise
Price
|
Intrinsic
Value
|
|||||||||||
|
Outstanding
at December 31, 2006
|
281,391 | $4.20 - $45.60 | $ | 29.55 | |||||||||||
|
Granted
|
526,000 | 8.10 - 41.40 | 33.15 | ||||||||||||
|
Exercised
|
(20,044 | ) | 4.20 - 28.65 | 25.05 | |||||||||||
|
Forfeited
|
(85,681 | ) | 4.20 - 45.60 | 38.25 | |||||||||||
|
Outstanding
at December 31, 2007
|
701,666 | 4.20 - 45.60 | 31.35 | $ | 44,600 | ||||||||||
|
Granted
|
2,103,238 | 0.25 - 5.25 | 0.44 | ||||||||||||
|
Exercised
|
- | - | - | ||||||||||||
|
Forfeited
|
(451,780 | ) | 0.50 - 45.60 | 34.88 | |||||||||||
|
Outstanding
at December 31, 2008
|
2,353,124 | 0.25 - 45.60 | 3.02 | - | |||||||||||
|
Granted
|
2,022,005 | 0.25 - 0.72 | 0.33 | ||||||||||||
|
Exercised
|
- | - | - | ||||||||||||
|
Forfeited
|
(81,687 | ) | 0.29 - 45.60 | 2.66 | |||||||||||
|
Outstanding
at December 31, 2009
|
4,293,442 | 0.25 - 45.60 | 1.76 | $ | 1,531,693 | ||||||||||
|
Exercisable
at December 31, 2009
|
2,536,134 | $0.25 - $45.60 | $ | 2.73 | $ | 843,250 | |||||||||
|
Options Outstanding at
December 31, 2009
|
|
|
Options Exercisable at
December 31, 2009
|
|
||||||||||||||
|
Exercise Price
|
Number of
Shares
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Life (years)
|
|
|
Number of
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
|||||
| $0.25-18.60 |
4,107,611
|
$
|
0.55
|
8.82
|
2,351,936
|
$
|
0.71
|
|||||||||||
| $18.61-21.75 |
86,536
|
19.73
|
2.39
|
86,542
|
19.73
|
|||||||||||||
| $21.76-24.00 |
20,267
|
23.26
|
7.66
|
18,604
|
23.26
|
|||||||||||||
| $24.01-31.50 |
17,016
|
29.65
|
4.30
|
17,036
|
29.65
|
|||||||||||||
| $31.51-45.60 |
62,012
|
42.20
|
5.85
|
62,016
|
42.20
|
|||||||||||||
|
4,293,442
|
$
|
1.76
|
8.90
|
2,536,134
|
$
|
2.73
|
||||||||||||
|
|
|
As of December 31, 2009
|
|
|
As of December 31, 2008
|
|
||||||||||
|
Unvested Stock Option
Awards
|
|
Shares
|
|
|
Weighted Average
Grant Date Fair Value
|
|
|
Shares
|
|
|
Weighted Average
Grant Date Fair Value
|
|
||||
|
Unvested
at January 1,
|
1,240,036
|
$
|
0.69
|
480,989
|
$
|
32.70
|
||||||||||
|
Awards
|
1,847,000
|
$
|
0.29
|
2,103,238
|
$
|
0.44
|
||||||||||
|
Forfeitures
|
(57,437
|
)
|
$
|
1.03
|
(394,914
|
)
|
$
|
35.51
|
||||||||
|
Vestings
|
(1,272,291
|
)
|
$
|
0.56
|
(949,277
|
)
|
$
|
1.84
|
||||||||
|
Unvested
at December 31,
|
1,757,308
|
$
|
0.57
|
1,240,036
|
$
|
0.69
|
||||||||||
|
|
|
Years Ended December 31,
|
|
|||||||||
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|||
|
Expected
holding period (years)
|
5.0
|
5.0
|
8.4
|
|||||||||
|
Risk-free
interest rate
|
2.72
|
%
|
2.28
|
%
|
4.61
|
%
|
||||||
|
Dividend
yield
|
0
|
%
|
0
|
%
|
0
|
%
|
||||||
|
Fair
value of options granted
|
$
|
0.23
|
$
|
0.19
|
$
|
1.91
|
||||||
|
Expected
volatility
|
91.86
|
%
|
91.86
|
%
|
97.4
|
%
|
||||||
|
Forfeiture
rate
|
15.38
|
%
|
15.21
|
%
|
15.21
|
%
|
||||||
|
|
|
Years Ended December 31,
|
|
|||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Research
and development
|
$
|
107,046
|
$
|
528,419
|
$
|
372,186
|
||||||
|
General
and administrative
|
502,236
|
(4,548,759
|
)
|
7,603,215
|
||||||||
|
Sales
and marketing
|
29,725
|
(31,019
|
)
|
191,338
|
||||||||
|
Stock-based
compensation expense before income taxes
|
639,007
|
(4,051,359
|
)
|
8,166,739
|
||||||||
|
Income
tax benefit
|
-
|
-
|
-
|
|||||||||
|
Total
stock-based compensation expense after income taxes
|
$
|
639,007
|
$
|
(4,051,359
|
)
|
$
|
8,166,739
|
|||||
|
15.
|
Material
Agreements
|
|
16.
|
Earnings Per Share and Warrant
Information
|
|
|
|
Years Ended December 31,
|
|
|||||||||
|
2009
|
2008
|
2007
|
||||||||||
|
Numerator:
|
||||||||||||
|
Net
loss
|
$
|
(33,940,363
|
)
|
$
|
(8,024,240
|
)
|
$
|
(70,812,688
|
)
|
|||
|
Denominator:
|
||||||||||||
|
Weighted
average shares
|
9,002,816
|
7,032,288
|
5,333,834
|
|||||||||
|
Basic
and diluted net loss per share
|
$
|
(3.77
|
)
|
$
|
(1.14
|
)
|
$
|
(13.28
|
)
|
|||
|
|
|
December 31,
|
|
|||||||||
|
|
|
2009
|
|
|
2008
|
|
|
2007
|
|
|||
|
Convertible
preferred stock
|
-
|
500,000
|
333,333
|
|||||||||
|
Convertible
debt
|
333,333
|
491,847
|
491,847
|
|||||||||
|
Warrants
|
8,954,203
|
4,008,377
|
3,864,920
|
|||||||||
|
Options
|
4,293,442
|
2,353,124
|
701,669
|
|||||||||
|
Total
|
|
13,580,978
|
|
7,353,348
|
|
5,391,769
|
||||||
|
|
|
Number of
Shares
|
|
Exercise
Price
Per Share
|
|
Weighted
Average
Exercise Price
|
|
||
|
Outstanding
at December 31, 2006
|
2,311,066
|
$3.75–$143.25
|
$
|
25.80
|
|||||
|
Granted
|
1,605,628
|
11.25 – 28.50
|
22.20
|
||||||
|
Exercised
|
(6,111
|
)
|
7.35 – 7.35
|
7.35
|
|||||
|
Forfeited
|
(45,662
|
)
|
3.75 – 67.05
|
49.50
|
|||||
|
Outstanding
at December 31, 2007
|
3,864,921
|
3.75 – 143.25
|
7.50
|
||||||
|
Granted
|
1,433,355
|
3.00 – 24.75
|
2.97
|
||||||
|
Exercised
|
(611,895
|
)
|
3.75 – 67.05
|
3.00
|
|||||
|
Forfeited
|
(678,006
|
)
|
6.75 – 6.75
|
6.75
|
|||||
|
Outstanding
at December 31, 2008
|
4,008,377
|
1.65 –143.25
|
11.00
|
||||||
|
Granted
|
5,904,487
|
0.10 – 15.41
|
6.44
|
||||||
|
Exercised
|
(80,000
|
)
|
0.10 - 0.10
|
0.10
|
|||||
|
Forfeited
|
(878,661
|
)
|
3.00 – 67.05
|
38.58
|
|||||
|
Outstanding
at December 31, 2009
|
8,954,203
|
$0.10–$143.25
|
$
|
2.98
|
|||||
|
Warrants Outstanding and Exercisable
At December 31, 2009
|
|
||||||||||
|
Exercise Price
|
Number of
Shares
|
|
Weighted
Average
Exercise Price
|
|
|
Expiration Dates
|
|
||||
| $ |
0.10-6.75
|
7,623,800
|
$
|
2.73
|
2011-2014
|
||||||
| $ |
11.25-11.55
|
755,818
|
8.33
|
2011-2014
|
|||||||
| $ |
15.90-18.75
|
7,500
|
18.75
|
2010-2010
|
|||||||
| $ |
22.50-22.50
|
539,683
|
20.58
|
2011-2012
|
|||||||
| $ |
28.50-43.20
|
26,005
|
38,07
|
2012-2013
|
|||||||
| $ |
67.05-143.25
|
1,397
|
143.25
|
2010-2010
|
|||||||
| $ |
0.10-143.25
|
8,954,203
|
$
|
2.98
|
2010-2014
|
||||||
|
17.
|
Unaudited Quarterly Results of
Operations
|
|
|
|
Quarters Ended
|
|
|||||||||||||
|
|
|
Dec. 31,
2009
|
|
|
Sept. 30,
2009
|
|
|
June 30,
2009
|
|
|
March. 31
2009
|
|
||||
|
Total
revenue
|
$
|
2,430,365
|
$
|
674,394
|
$
|
641,463
|
$
|
814,487
|
||||||||
|
Research
and development
|
656,177
|
605,821
|
872,189
|
761,504
|
||||||||||||
|
General
and administrative
|
495,402
|
548,202
|
675,941
|
1,077,218
|
||||||||||||
|
Facilities
realignment and impairment of fixed assets
|
-
|
-
|
51,221
|
126,609
|
||||||||||||
|
Registration
rights penalty
|
21,384
|
65,581
|
64,868
|
64,155
|
||||||||||||
|
Total
costs and expenses
|
1,172,963
|
1,219,604
|
1,664,219
|
2,029,486
|
||||||||||||
|
Income
(loss) from operations
|
1,257,402
|
(545,210
|
)
|
(1,022,756
|
)
|
(1,214,999
|
)
|
|||||||||
|
Interest
expense, net
|
364,356
|
408,817
|
400,211
|
447,402
|
||||||||||||
|
Non-cash
debt extinguishment
|
35,909,507
|
-
|
-
|
-
|
||||||||||||
|
Gain
on settlement of lease obligations
|
-
|
(1,953,977
|
)
|
-
|
-
|
|||||||||||
|
Revaluation
of warrant liability
|
294,668
|
-
|
-
|
-
|
||||||||||||
|
Gain
on settlement of registration rights penalty
|
(1,385,017
|
)
|
-
|
-
|
-
|
|||||||||||
|
Total
other expense (credit), net
|
34,819,158
|
(1,953,977
|
)
|
-
|
-
|
|||||||||||
|
(Loss) income
before benefit from state taxes
|
(33,926,112
|
)
|
999,950
|
(1,422,967
|
)
|
(1,662,401
|
)
|
|||||||||
|
Sale
of State of New Jersey net operating losses
|
2,071,168
|
-
|
-
|
-
|
||||||||||||
|
Net
(loss) income
|
$
|
(31,854,944
|
)
|
$
|
999,950
|
$
|
(1,422,967
|
)
|
$
|
(1,662,401
|
)
|
|||||
|
Net
(loss) income per common share:
|
||||||||||||||||
|
Basic
|
$
|
(2.26
|
)
|
$
|
0.14
|
$
|
(0.20
|
)
|
$
|
(0.23
|
)
|
|||||
|
Diluted
|
$
|
(2.26
|
)
|
$
|
0.14
|
$
|
(0.20
|
)
|
$
|
(0.23
|
)
|
|||||
|
Weighted
average number of shares:
|
||||||||||||||||
|
Basic
|
14,088,966
|
7,291,703
|
7,291,703
|
7,282,802
|
||||||||||||
|
Diluted
|
14,088,966
|
7,398,739
|
7,291,703
|
7,282,802
|
||||||||||||
|
|
|
Quarters Ended
|
|
|||||||||||||
|
|
|
Dec. 31,
2008
|
|
|
Sept. 30,
2008
|
|
|
June 30,
2008
|
|
|
March. 31,
2008
|
|
||||
|
Total
revenue
|
$
|
407,038
|
$
|
877,075
|
$
|
1,146,532
|
$
|
719,751
|
||||||||
|
Cost
of sales
|
320
|
396
|
-
|
102,774
|
||||||||||||
|
Research
and development
|
1,374,066
|
1,488,214
|
1,613,798
|
1,793,558
|
||||||||||||
|
General
and administrative
|
989,124
|
996,744
|
417,585
|
(2,528,608
|
)
|
|||||||||||
|
Sales
and marketing
|
(203,402
|
)
|
8,760
|
192,413
|
177,736
|
|||||||||||
|
Facilities
realignment and impairment of fixed assets
|
54,786
|
40,438
|
37,382
|
2,432,828
|
||||||||||||
|
Other
|
65,580
|
147,173
|
64,868
|
64,868
|
||||||||||||
|
Total
costs and expenses
|
2,280,474
|
2,681,725
|
2,326,046
|
2,043,156
|
||||||||||||
|
Loss
from operations
|
(1,873,436
|
)
|
(1,804,650
|
)
|
(1,179,514
|
)
|
(1,323,405
|
)
|
||||||||
|
Interest
expense, net
|
458,515
|
553,771
|
451,834
|
440,892
|
||||||||||||
|
Loss
before benefit from state taxes
|
(2,331,951
|
)
|
(2,358,421
|
)
|
(1,631,348
|
)
|
(1,764,297
|
)
|
||||||||
|
Sale
of State of New Jersey net operating losses
|
61,777
|
-
|
-
|
-
|
||||||||||||
|
Net
loss
|
$
|
(2,270,174
|
)
|
$
|
(2,358,421
|
)
|
$
|
(1,631,348
|
)
|
$
|
(1,764,297
|
)
|
||||
|
Net
loss per common share:
|
||||||||||||||||
|
Basic
and diluted
|
$
|
(0.32
|
)
|
$
|
(0.33
|
)
|
$
|
(0.23
|
)
|
$
|
(0.27
|
)
|
||||
|
Weighted
average number of shares:
|
||||||||||||||||
|
Basic
and diluted
|
7,206,117
|
7,197,821
|
7,197,684
|
6,519,782
|
||||||||||||
|
18.
|
Subsequent
Events
|
|
|
|
September 30,
2010
|
|
|
December 31,
2009
|
|
||
|
(Unaudited)
|
||||||||
|
ASSETS
|
||||||||
|
Current assets:
|
||||||||
|
Cash
and cash equivalents
|
$
|
1,153,819
|
$
|
2,173,039
|
||||
|
Other
current assets
|
110,765
|
120,527
|
||||||
|
Total
current assets
|
1,264,584
|
2,293,566
|
||||||
|
Debt
issuance costs, net
|
2,044,421
|
—
|
||||||
|
Property
and equipment, net
|
27,799
|
114,024
|
||||||
|
Other
assets
|
290,352
|
225,356
|
||||||
|
TOTAL
ASSETS
|
$
|
3,627,156
|
$
|
2,632,946
|
||||
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable
|
$
|
2,219,249
|
$
|
2,432,976
|
||||
|
Fair
value of derivative financial instruments
|
10,180,233
|
2,634,487
|
||||||
|
Accrued
expenses and other
|
3,508,350
|
3,135,013
|
||||||
|
Interest
payable and accrued expenses due to a related party
|
190,093
|
111,560
|
||||||
|
Total
current liabilities
|
16,097,925
|
8,314,036
|
||||||
|
Promissory
note due to a related party
|
1,750,000
|
1,750,000
|
||||||
|
Senior
subordinated convertible promissory notes, net of discount (face amount
$1.8 million)
|
26,859
|
—
|
||||||
|
Deferred
revenue and other
|
746,237
|
821,237
|
||||||
|
Convertible
note payable
|
500,000
|
500,000
|
||||||
|
Total
liabilities
|
19,121,021
|
11,385,273
|
||||||
|
Commitments
and contingencies
|
||||||||
|
Stockholders’
equity (deficit):
|
||||||||
|
Common
stock, par value $0.015 per share; 400,000,000 shares authorized, at
September 30, 2010 and December 31, 2009; 68,755,067 and 62,398,817
shares issued and outstanding at September 30, 2010 and December 31, 2009,
respectively
|
1,031,326
|
935,982
|
||||||
|
Additional
paid-in capital
|
213,139,437
|
204,642,912
|
||||||
|
Accumulated
deficit
|
(229,664,628
|
)
|
(214,331,221
|
)
|
||||
|
Total
stockholders’ equity (deficit)
|
(15,493,865
|
)
|
(8,752,327
|
)
|
||||
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
|
$
|
3,627,156
|
$
|
2,632,946
|
||||
|
|
|
Three months ended
September 30,
|
|
|
Nine months ended
September 30,
|
|
||||||||||
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
||||
|
Revenues:
|
||||||||||||||||
|
Product
development
|
$
|
3,956
|
$
|
476,928
|
$
|
15,466
|
$
|
1,557,569
|
||||||||
|
Other
revenue
|
—
|
197,466
|
126,067
|
572,774
|
||||||||||||
|
Total
revenues
|
3,956
|
674,394
|
141,533
|
2,130,343
|
||||||||||||
|
Cost
and expenses:
|
||||||||||||||||
|
Research
and development
|
604,651
|
605,821
|
2,083,087
|
2,239,514
|
||||||||||||
|
General
and administrative
|
966,907
|
548,202
|
4,283,243
|
2,301,361
|
||||||||||||
|
Facilities
realignment and impairment of fixed assets
|
—
|
—
|
—
|
177,831
|
||||||||||||
|
Registration
rights penalty
|
—
|
65,581
|
—
|
194,603
|
||||||||||||
|
Total
cost and expenses
|
1,571,558
|
1,219,604
|
6,366,330
|
4,913,309
|
||||||||||||
|
Loss
from operations
|
(1,567,602
|
)
|
(545,210
|
)
|
(6,224,797
|
)
|
(2,782,966
|
)
|
||||||||
|
Interest
(income) expense:
|
||||||||||||||||
|
Interest
(income)
|
(750
|
)
|
(24
|
)
|
(1,182
|
)
|
(427
|
)
|
||||||||
|
Interest
expense to related parties
|
390,774
|
393,839
|
449,029
|
1,173,565
|
||||||||||||
|
Interest
(credit) expense
|
(3,548
|
)
|
15,002
|
29,367
|
83,292
|
|||||||||||
|
Non-cash
interest expense for warrants issued on induced conversion of
debt
|
2,832,706
|
—
|
2,832,706
|
—
|
||||||||||||
|
Non-cash
interest expense for warrants issued to investors
|
485,029
|
—
|
485,029
|
—
|
||||||||||||
|
Interest
expense, net
|
3,704,211
|
408,817
|
3,794,949
|
1,256,430
|
||||||||||||
|
Increase
in fair value of derivative financial instruments
|
569,301
|
—
|
5,313,661
|
—
|
||||||||||||
|
Gain
on settlement of lease obligations
|
—
|
(1,953,977
|
)
|
—
|
(1,953,977
|
)
|
||||||||||
|
Net
(loss) income
|
$
|
(5,841,114
|
)
|
$
|
999,950
|
$
|
(15,333,407
|
)
|
$
|
(2,085,419
|
)
|
|||||
|
Net
(loss) income per common share:
|
||||||||||||||||
|
Basic
|
$
|
(0.09
|
)
|
$
|
0.14
|
$
|
(0.24
|
)
|
$
|
(0.29
|
)
|
|||||
|
Diluted
|
$
|
(0.09
|
)
|
$
|
0.14
|
$
|
(0.24
|
)
|
$
|
(0.29
|
)
|
|||||
|
Weighted
average number of common shares:
|
||||||||||||||||
|
Basic
|
62,685,276
|
7,291,703
|
62,716,803
|
7,288,802
|
||||||||||||
|
Diluted
|
62,685,276
|
7,398,739
|
62,716,803
|
7,288,802
|
||||||||||||
|
|
|
|
|
|
|
Additional
|
|
|
|
|
Total
|
|
||||||||
|
|
|
Common Stock
|
|
|
Paid-in
|
|
|
Accumulated
|
|
|
Stockholders’
|
|
||||||||
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Deficit
|
|
|
Equity (Deficit)
|
|
|||||
|
Balance
at December 31, 2009
|
62,398,817
|
$
|
935,982
|
$
|
204,642,912
|
$
|
(214,331,221
|
)
|
$
|
(8,752,327
|
)
|
|||||||||
|
Non-cash
stock based compensation expense, net
|
—
|
—
|
1,989,631
|
—
|
1,989,631
|
|||||||||||||||
|
Issuance
of common stock for services rendered
|
520,000
|
7,800
|
278,600
|
—
|
286,400
|
|||||||||||||||
|
Issuance
of common stock upon conversion of convertible debt
|
5,836,250
|
87,544
|
1,079,848
|
—
|
1,167,392
|
|||||||||||||||
|
Issuance
of warrants to investment finders included in debt issuance
costs
|
—
|
—
|
1,954,831
|
—
|
1,954,831
|
|||||||||||||||
|
Issuance
of warrants for services rendered
|
—
|
—
|
342,400
|
—
|
342,400
|
|||||||||||||||
|
Non-cash
interest expense for warrants issued on induced conversion of
convertible debt
|
—
|
—
|
2,832,706
|
—
|
2,832,706
|
|||||||||||||||
|
Other
issuance of warrants
|
—
|
—
|
18,509
|
—
|
18,509
|
|||||||||||||||
|
Net
loss for the nine months ended September 30, 2010
|
—
|
—
|
—
|
(15,333,407
|
)
|
(15,333,407
|
)
|
|||||||||||||
|
Balance
at September 30, 2010
|
68,755,067
|
$
|
1,031,326
|
$
|
213,139,437
|
$
|
(229,664,628
|
)
|
$
|
(15,493,865
|
)
|
|||||||||
|
|
|
Nine Months Ended
September 30,
|
|
|||||
|
|
|
2010
|
|
|
2009
|
|
||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net
loss
|
$
|
(15,333,407
|
)
|
$
|
(2,085,419
|
)
|
||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
|
Depreciation
expense
|
81,945
|
160,026
|
||||||
|
Stock
based compensation charges
|
1,989,631
|
460,272
|
||||||
|
Non-cash
increase in fair value of derivative financial instruments
|
5,313,661
|
—
|
||||||
|
Interest
expense for warrants issued on induced conversion of convertible
debt
|
2,832,706
|
—
|
||||||
|
Warrants
issued to investors on conversion
|
485,029
|
—
|
||||||
|
Gain
on settlement of lease obligations
|
—
|
(1,953,977
|
)
|
|||||
|
Warrants
issued for services rendered
|
342,400
|
133,483
|
||||||
|
Common
stock issued for services rendered
|
286,400
|
—
|
||||||
|
Accrued
registration rights penalty
|
—
|
194,603
|
||||||
|
Facilities
realignment and impairment costs
|
—
|
177,831
|
||||||
|
Deferred
revenue
|
(75,000
|
)
|
(562,667
|
)
|
||||
|
Other
|
350,317
|
311,034
|
||||||
|
Change
in operating assets and liabilities:
|
||||||||
|
Accounts
receivable
|
—
|
(308,921
|
)
|
|||||
|
Other
assets
|
(55,234
|
)
|
108,194
|
|||||
|
Accounts
payable
|
(213,727
|
)
|
(38,728
|
)
|
||||
|
Accrued
expenses and other liabilities
|
380,401
|
1,564,995
|
||||||
|
Interest
payable and accrued expenses to related parties
|
95,925
|
1,283,111
|
||||||
|
Net
cash used in operating activities
|
(3,518,953
|
)
|
(556,163
|
)
|
||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Increase
due to changes in restricted cash
|
—
|
124,245
|
||||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Proceeds
from senior secured subordinated convertible debentures
|
2,935,000
|
—
|
||||||
|
Convertible
debentures issuance costs
|
(435,267
|
)
|
—
|
|||||
|
Net
proceeds from sale of manufacturing asset
|
—
|
568,723
|
||||||
|
Net
cash provided by financing activities
|
2,499,733
|
568,723
|
||||||
|
Net
(decrease) increase in cash and cash equivalents
|
(1,019,220
|
)
|
136,805
|
|||||
|
Cash
and cash equivalents at beginning of the period
|
2,173,039
|
222,821
|
||||||
|
Cash
and cash equivalents at end of the period
|
$
|
1,153,819
|
$
|
359,626
|
||||
|
SUPPLEMENTAL
DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||||
|
Interest
paid
|
$
|
2,291
|
$
|
2,197
|
||||
|
Repayment
of secured convertible debenture in exchange for milestone
payment
|
—
|
2,500,000
|
||||||
|
Issuance
of common stock upon conversion of interest on convertible
debt
|
17,392
|
—
|
||||||
|
Issuance
of common stock upon conversion of convertible debt
|
1,167,392
|
—
|
||||||
|
Warrants
issued to investment finders included in debt issuance
costs
|
1,954,831
|
—
|
||||||
|
1.
|
Liquidity and Basis of
Presentation
|
|
2.
|
Significant Accounting
Policies
|
|
3.
|
Property and Equipment,
Net
|
|
|
|
September 30,
2010
|
|
|
December 31,
2009
|
|
||
|
|
|
(Unaudited)
|
|
|
|
|||
|
Manufacturing
and laboratory equipment
|
$
|
1,872,180
|
$
|
1,875,930
|
||||
|
Furniture
and fixtures
|
156,543
|
156,543
|
||||||
|
Office
equipment
|
334,065
|
345,424
|
||||||
|
Leasehold
improvements
|
367,818
|
367,818
|
||||||
|
Software
|
205,210
|
205,210
|
||||||
|
2,935,816
|
2,950,925
|
|||||||
|
Less:
Accumulated depreciation and amortization
|
(2,908,017
|
)
|
(2,836,901
|
)
|
||||
|
Property
and equipment, net
|
$
|
27,799
|
$
|
114,024
|
||||
|
4.
|
Accrued Expenses and
Other
|
|
|
|
September 30,
|
|
|
December 31,
|
|
||
|
|
|
2010
|
|
|
2009
|
|
||
|
(Unaudited)
|
||||||||
|
Compensation,
accrued bonuses and benefits payable
|
$
|
482,718
|
$
|
413,743
|
||||
|
Continuous
motion patch machine costs and delivery
|
174,202
|
183,452
|
||||||
|
Reimbursement
of development costs to Ferring (1)
|
1,354,567
|
1,386,919
|
||||||
|
Accrued
insurance costs
|
-
|
101,224
|
||||||
|
Accounting,
legal and consulting fees
|
676,652
|
371,243
|
||||||
|
Outside
services
|
330,027
|
334,095
|
||||||
|
Food
and Drug Administration fees
|
257,465
|
193,521
|
||||||
|
Other
|
232,719
|
150,816
|
||||||
|
Accrued
expenses and other
|
$
|
3,508,350
|
$
|
3,135,013
|
||||
|
(1)
|
Represents estimated liability
for advances in 2009 of research and development costs under the License
and Development Agreement with Ferring (see Note
8).
|
|
5.
|
Promissory Note Due to a Related
Party
|
|
6.
|
Senior Subordinated Convertible
Promissory Notes, Net of
Discount
|
|
7.
|
June 2010 Subordinated
Convertible Promissory Notes
|
|
8.
|
Termination of the Ferring
Agreement
|
|
a)
|
all licenses and other rights
granted to the Company shall, subject to the continued payment to Ferring
of certain royalty payments under the Agreement, be converted to and
continue as exclusive, worldwide irrevocable, perpetual, sub-licensable
licenses to develop, make, have made, use, sell, offer to sell, lease,
distribute, import and export the
Product;
|
|
b)
|
all licenses and other rights
granted to Ferring under the Agreement shall be terminated as of the
effective date of the
termination;
|
|
c)
|
Ferring shall grant to the
Company an irrevocable, perpetual, exclusive, royalty-free, sub-licensable
license to practice certain intellectual property jointly developed under
the Agreement with respect to the iontophoretic administration of
infertility hormone;
|
|
d)
|
Ferring shall cease to use and
shall assign to the Company all of its rights, title and interest in and
to all clinical, technical and other relevant reports, records, data,
information and materials relating exclusively to the Product and all
regulatory filings (including any NDA, 510(k) or similar regulatory
filing) relating exclusively to the Product and provide the Company one
copy of each physical embodiment of the aforementioned items within thirty
(30) days after such
termination;
|
|
e)
|
Ferring shall cease to use any
Know-How, Information or Materials arising under this Agreement to the
extent such Know-How, Information or Materials is owned by Ferring and
shall promptly return to the Company all such materials;
and
|
|
f)
|
Ferring is required to return to
the Company all information knowhow and other materials and records
in their possession or control relating exclusively to the Product (as
such term is defined in the
Agreement).
|
|
9.
|
Related Party
Transaction
|
|
10.
|
Stock-Based
Compensation
|
|
|
|
Number of
Shares
|
|
|
Exercise Price
Per Share
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Intrinsic
Value
|
|
||||
|
Outstanding
at January 1, 2010
|
4,293,442
|
$
|
0.35
- $0.65
|
$
|
0.50
|
-
|
||||||||||
|
Granted
|
12,444,724
|
0.35
– 0.65
|
0.50
|
-
|
||||||||||||
|
Exercised
|
-
|
-
|
-
|
-
|
||||||||||||
|
Forfeited
|
(160,645
|
)
|
0.29
- 45.60
|
1.25
|
-
|
|||||||||||
|
Outstanding
at September 30, 2010
|
16,577,521
|
0.25
- 45.60
|
0.82
|
$
|
1,549,654
|
|||||||||||
|
Exercisable
at September 30, 2010
|
8,129,735
|
$
|
0.25
- $45.60
|
$
|
1.17
|
$
|
849,681
|
|||||||||
|
Options Outstanding at
September 30, 2010
|
|
|
Options Exercisable at
September 30, 2010
|
|
|||||||||||||||
|
Exercise Price
|
Number of
Shares
|
|
Weighted
Average
Exercise Price
|
|
|
Weighted
Average
Remaining
Contractual
Life (years)
|
|
|
Number of
Shares
|
|
|
Weighted
Average
Exercise Price
|
|
||||||
| $ |
0.25-0.30
|
3,019,466
|
$
|
0.27
|
8.59
|
2,226,341
|
$
|
0.27
|
|||||||||||
| $ |
0.31-0.35
|
5,747,639
|
0.35
|
9.33
|
2,303,030
|
0.35
|
|||||||||||||
| $ |
0.36-0.55
|
1,608,851
|
0.51
|
8.39
|
843,791
|
0.52
|
|||||||||||||
| $ |
0.56-0.65
|
5,747,639
|
0.65
|
9.34
|
2,303,030
|
0.65
|
|||||||||||||
| $ |
0.66-45.60
|
453,926
|
13.62
|
4.97
|
453,543
|
13.61
|
|||||||||||||
|
16,577,521
|
$
|
0.82
|
9.05
|
8,129,735
|
$
|
1.17
|
|||||||||||||
|
|
|
As of September 30, 2010
|
|
|
As of September 30, 2009
|
|
||||||||||
|
Unvested Stock Option
Awards
|
|
Stock
Options
|
|
|
Weighted Average
Grant Date Fair Value
|
|
|
Stock
Options
|
|
|
Weighted Average
Grant Date Fair
Value
|
|
||||
|
Unvested at January 1,
|
1,757,308
|
$
|
0.69
|
1,240,078
|
$
|
0.69
|
||||||||||
|
Awards
|
12,444,724
|
$
|
1.00
|
1,847,000
|
$
|
0.29
|
||||||||||
|
Forfeitures
|
-
|
-
|
(40,475
|
)
|
$
|
1.14
|
||||||||||
|
Vestings
|
(5,754,246
|
)
|
$
|
0.49
|
(1,015,948
|
)
|
$
|
0.59
|
||||||||
|
Unvested
at September 30,
|
8,447,786
|
$
|
0.57
|
2,030,655
|
$
|
0.57
|
||||||||||
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
||||||||||
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
||||
|
(1)
|
||||||||||||||||
|
Expected
holding period (years)
|
-
|
5.0
|
5.0
|
5.0
|
||||||||||||
|
Risk-free
interest rate
|
-
|
2.72
|
%
|
2.36
|
%
|
2.72
|
%
|
|||||||||
|
Dividend
yield
|
-
|
0
|
%
|
0
|
%
|
0
|
%
|
|||||||||
|
Fair
value of options granted
|
-
|
$
|
0.21
|
$
|
0.36
|
$
|
0.21
|
|||||||||
|
Expected
volatility
|
-
|
91.9
|
%
|
91.9
|
%
|
91.9
|
%
|
|||||||||
|
Forfeiture
rate
|
-
|
15.38
|
%
|
14.46
|
%
|
15.38
|
%
|
|||||||||
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
||||||||||
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
||||
|
Research
and development
|
$
|
55,921
|
$
|
42,911
|
$
|
383,562
|
$
|
78,649
|
||||||||
|
General
and administrative
|
297,952
|
189,055
|
1,606,069
|
381,623
|
||||||||||||
|
Stock-based
compensation expense before income taxes
|
353,873
|
231,966
|
1,989,631
|
460,272
|
||||||||||||
|
Income
tax benefit
|
-
|
-
|
-
|
-
|
||||||||||||
|
Total
stock-based compensation expense after income taxes
|
$
|
353,873
|
$
|
231,966
|
$
|
1,989,631
|
$
|
460,272
|
||||||||
|
11.
|
Material
Agreements
|
|
12.
|
Merger
Agreement
|
|
|
·
|
To the holders of MediSync common
stock, five shares of the Company’s common stock for each share of
MediSync’s common stock.
|
|
|
·
|
To the holders of convertible
notes and other indebtedness of MediSync, five shares of the Company’s
common stock for each $1.00 of MediSync
debt.
|
|
|
·
|
To the holders of MediSync
warrants, warrants to purchase five shares of the Company’s common stock,
at a $0.20 exercise price, for each warrant to purchase (i) a
share of MediSync common stock and (ii) $1 of convertible note to be
issued by MediSync.
|
|
|
·
|
To the holders of MediSync
options, options to purchase five shares of the Company’s common stock for
each option to purchase a share of MediSync common
stock.
|
|
13.
|
Loss Per Share and Warrant
Information
|
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
||||||||||
|
|
|
2010
|
|
|
2009
|
|
|
2010
|
|
|
2009
|
|
||||
|
Numerator:
|
||||||||||||||||
|
Net
(loss) income
|
$
|
(5,841,114
|
)
|
$
|
999,950
|
$
|
(15,333,407
|
)
|
$
|
(2,085,419
|
)
|
|||||
|
Denominator:
|
||||||||||||||||
|
Weighted
average shares:
|
||||||||||||||||
|
Basic
|
62,685,276
|
7,291,703
|
62,716,803
|
7,288,802
|
||||||||||||
|
Diluted
|
62,685,276
|
7,398,739
|
62,716,803
|
7,288,802
|
||||||||||||
|
Net
(loss) income per share:
|
||||||||||||||||
|
Basic
|
$
|
(0.09
|
)
|
$
|
0.14
|
$
|
(0.24
|
)
|
$
|
(0.29
|
)
|
|||||
|
Diluted
|
$
|
(0.09
|
)
|
$
|
0.14
|
$
|
(0.24
|
)
|
$
|
(0.29
|
)
|
|||||
|
|
|
As of September 30,
|
|
|||||
|
|
|
2010
|
|
|
2009
|
|
||
|
Convertible
preferred stock
|
-
|
500,000
|
||||||
|
Convertible
debt
|
9,477,454
|
365,180
|
||||||
|
Warrants
|
32,489,513
|
3,530,990
|
||||||
|
Options
|
16,557,521
|
4,135,402
|
||||||
|
Total
|
58,524,488
|
8,531,572
|
||||||
|
|
|
Warrants Outstanding and Exercisable
At September 30, 2010
|
|
|
|
||||||||||
|
Exercise Price
|
Number of
Shares
|
|
Weighted
Average
Exercise Price
|
|
|
Expiration Dates
|
|
|
Fair Value of
Warrants Classified
As Derivative
Liabilities
|
|
|||||
|
$
|
0.10-0.20
|
12,345,000
|
$
|
0.20
|
2012
-2015
|
$
|
3,084,484
|
||||||||
|
$
|
0.21-0.25
|
14,177,390
|
0.25
|
2014-
2015
|
2,318,166
|
||||||||||
|
$
|
0.26-3.75
|
4,265,992
|
2.57
|
2011-
2015
|
-
|
||||||||||
|
$
|
3.76-143.25
|
1,701,131
|
17.14
|
2010-
2014
|
51,852
|
||||||||||
|
$
|
0.10-143.25
|
32,489,513
|
1.00
|
2010-2015
|
$
|
5,454,502
|
|||||||||
|
|
|
2010
Transactions
|
|
|
|
Issued
in connection the 2010 Notes (see Note 6)
|
12,495,000
|
|||
|
Issued
in connection the June 2010 Notes (see Note 7)
|
2,760,000
|
|||
|
Issued
in connection with September 30, 2010 conversion of the June 2010 Notes
(see Note 7)
|
6,986,250
|
|||
|
Issued
to vendors and others
|
1,294,060
|
|||
|
Total
|
23,535,310
|
|||
|
|
|
Years Ended December 31,
|
||||||||||
|
|
|
2009 vs. 2008
|
|
|
2008 vs. 2007
|
|
|
2007 vs. 2006
|
|
|||
|
Revenues
|
$
|
1,410,313
|
$
|
366,309
|
$
|
319,977
|
||||||
|
Cost
of sales
|
(103,490
|
)
|
(1,387,357
|
)
|
1,250,133
|
|||||||
|
Research
and development
|
(3,373,945
|
)
|
(2,687,326
|
)
|
876,734
|
|||||||
|
General
and administrative
|
2,921,918
|
(15,494,398
|
)
|
8,720,430
|
||||||||
|
Sales
and marketing
|
(175,507
|
)
|
(6,075,855
|
)
|
5,130,101
|
|||||||
|
Impairment
of fixed assets
|
(2,387,603
|
)
|
2,482,797
|
(110,213
|
)
|
|||||||
|
Non-cash
warrant expense consultants
|
(81,592
|
)
|
(17,033,408
|
)
|
17,115,000
|
|||||||
|
Registration
rights penalty
|
(44,909
|
)
|
713
|
-
|
||||||||
|
Loss
from operations
|
(4,655,441
|
)
|
(40,561,143
|
)
|
32,662,208
|
|||||||
|
Interest
expense, net
|
$
|
(284,226
|
)
|
$
|
(1,883,383
|
)
|
$
|
(1,628,667
|
)
|
|||
|
Year Ended December 31,
|
||||||||
|
2008
|
2007
|
|||||||
|
Non-cash
interest expense:
|
||||||||
|
Value
of warrant amortization
|
$ | — | $ | 766,112 | ||||
|
Offering
costs amortization
|
— | 11,404 | ||||||
|
Value
of warrants issued for Working Capital Facility extension
|
— | 888,762 | ||||||
|
Value
of beneficial conversion feature
|
231,403 | 231,547 | ||||||
|
Value
of warrants issued for financial consultants
|
— | 543,751 | ||||||
|
Total
non-cash interest expense
|
231,403 | 2,441,576 | ||||||
|
Coupon
and other interest
|
1,116,593 | 957,178 | ||||||
|
Interest
on Series B mandatorily convertible redeemable preferred
stock
|
600,000 | 600,000 | ||||||
|
Total
interest expense
|
$ | 1,947,996 | $ | 3,998,754 | ||||
|
a)
|
all licenses and other rights
granted to the Company shall, subject to the continued payment to Ferring
of certain royalty payments under the Agreement, be converted to and
continue as exclusive, worldwide irrevocable, perpetual, sub-licensable
licenses to develop, make, have made, use, sell, offer to sell, lease,
distribute, import and export the
Product;
|
|
b)
|
all licenses and other rights
granted to Ferring under the Agreement shall be terminated as of the
effective date of the
termination,
|
|
c)
|
Ferring shall grant to the
Company an irrevocable, perpetual, exclusive, royalty-free, sub-licensable
license to practice certain intellectual property jointly developed under
the Agreement with respect to the iontophoretic administration of
infertility hormone;
|
|
d)
|
Ferring shall cease to use and
shall assign to us all of its right, title and interest in and to all
clinical, technical and other relevant reports, records, data, information
and materials relating exclusively to the Product and all regulatory
filings (including any NDA, 510(k) or similar regulatory filing) relating
exclusively to the Product and provide to us one copy of each physical
embodiment of the aforementioned items within thirty (30) days after such
termination; and
|
|
e)
|
Ferring shall cease to use any
Know-How, Information or Materials arising under this Agreement to the
extent such Know-How, Information or Materials is owned by Ferring shall
promptly return to us all such
materials.
|
|
|
1.
|
The principal amount of all
indebtedness and accrued and unpaid interest thereon and stated value of
the Series B Preferred Stock owed by us to STSG in excess of $2.0 million
($2.0 million amount is defined as the “Remaining Debt”) which includes
the January 2006 Promissory Note, the 2006 Promissory Notes, $0.9 million
of Working Capital Facility were satisfied in full on December 24, 2009.
STSG converted $20.3 million of indebtedness and accrued and unpaid
interest and all issued and outstanding shares of Series B Preferred Stock
into 50,777,015 shares our common stock at a conversion price of $0.40 per
share
|
|
|
2.
|
The Remaining Debt shall be
evidenced by a promissory note (“2009 Promissory Note”) with interest
accruing at the rate of 6% per year and with the same due date as the
first debt security to expire pursuant to a Qualified Financing which is
February 2, 2013. The 2009 Promissory Note is secured by
a lien our assets, subordinate to the lien of any existing creditors that
have a lien senior to that of STSG and to any liens resulting from a
Qualified Financing.
|
|
|
3.
|
On December 28, 2009, we paid to
STSG $0.3 million to reduce the principal amount of the 2009 Promissory
Note to $1.8 million as of December 31, 2009. Upon a Qualified Financing
with gross proceeds in excess of $3.0 million, we shall make another
prepayment of $0.5 million. Upon a Qualified Financing with gross proceeds
in excess of $5.0 million, we shall make another prepayment of 50% of the
net proceeds from any Qualified Financing in excess of such
amounts.
|
|
|
At December 31, 2009
|
|||||||||||||||||||
|
|
Total
|
<1 Year
|
1-3 Years
|
3-5 Years
|
>5 Years
|
|||||||||||||||
|
Operating
lease obligations
|
$ | 809,668 | $ | 407,088 | $ | 402,580 | $ | - | $ | - | ||||||||||
|
Manufacturing
equipment
|
183,452 | 183,452 | - | - | - | |||||||||||||||
|
Insurance
financing obligation
|
101,224 | 101,224 | - | - | - | |||||||||||||||
|
Distribution
agreement
|
91,775 | 91,775 | - | - | - | |||||||||||||||
|
Debt
obligations
|
2,250,000 | - | 1,750,000 | - | 500,000 | |||||||||||||||
|
Advisory
agreement
|
90,000 | 90,000 | - | - | - | |||||||||||||||
|
Total
|
$ | 3,526,119 | $ | 873,539 | $ | 2,152,580 | $ | - | $ | 500,000 | ||||||||||
|
|
·
|
Women’s health, such as
infertility,
|
|
|
·
|
Migraine
treatment,
|
|
|
·
|
Pain management,
and
|
|
|
·
|
Metabolic diseases, such as
diabetes and osteoporosis.
|
|
|
Three Months
Ended
|
Nine Months
Ended
|
||||||
|
|
September 30, 2010
Versus
September 30, 2009
|
|||||||
|
Revenues
|
(99.4 | )% | (93.4 | )% | ||||
|
Research
and development
|
(0.2 | )% | (7.0 | )% | ||||
|
General
and administrative
|
76.4 | % | 86.1 | % | ||||
|
Facilities
realignment and impairment of fixed assets
|
- | (100.0 | )% | |||||
|
Registration
rights penalty
|
(100.0 | )% | (100.0 | )% | ||||
|
Interest
(income) expense, net
|
806.1 | % | 202.0 | % | ||||
|
Increase
in fair value of derivative financial instruments
|
100.0 | % | 100.0 | % | ||||
|
Gain
on settlement of lease obligations
|
(100.0 | )% | (100.0 | )% | ||||
|
Net
loss
|
(684.1 | )% | 635.3 | % | ||||
|
a)
|
all licenses and other rights
granted to us shall, subject to the continued payment to Ferring of
certain royalty payments under the Agreement, be converted to and continue
as exclusive, worldwide irrevocable, perpetual, sub-licensable licenses to
develop, make, have made, use, sell, offer to sell, lease, distribute,
import and export the
Product;
|
|
b)
|
all licenses and other rights
granted to Ferring under the Agreement shall be terminated as of the
effective date of the
termination;
|
|
c)
|
Ferring shall grant to us an
irrevocable, perpetual, exclusive, royalty-free, sub-licensable license to
practice certain intellectual property jointly developed under the
Agreement with respect to the iontophoretic administration of infertility
hormone;
|
|
d)
|
Ferring shall cease to use and
shall assign to us all of its rights, title and interest in and
to all clinical, technical and other relevant reports, records, data,
information and materials relating exclusively to the Product and all
regulatory filings (including any NDA, 510(k) or similar regulatory
filing) relating exclusively to the Product and provide us one copy of
each physical embodiment of the aforementioned items within thirty (30)
days after such termination;
|
|
e)
|
Ferring shall cease to use any
Know-How, Information or Materials arising under this Agreement to the
extent such Know-How, Information or Materials is owned by Ferring and
shall promptly return to us all such materials;
and
|
|
f)
|
Ferring is required to return to
us all information and our know-how and other materials and records in
their possession or control relating exclusively to the Product (as such
term is defined in the
Agreement).
|
|
|
Payments due by Period as of September 30, 2010
|
|||||||||||||||||||
|
|
Total
|
Less than
1 Year
|
1-3 Years
|
3-5 Years
|
More than
5 Years
|
|||||||||||||||
|
Operating
lease obligations
|
$ | 502,940 | $ | 401,439 | $ | 101,501 | $ | — | $ | — | ||||||||||
|
PMK
150 lease agreement
|
101,000 | 12,000 | 24,000 | 24,000 | 41,000 | |||||||||||||||
|
Debt
obligations (1)
|
4,035,000 | 1,750,000 | 1,785,000 | 500,000 | — | |||||||||||||||
|
Advisory
agreement
|
22,500 | 22,500 | — | — | — | |||||||||||||||
|
Total
|
$ | 4,661,440 | $ | 2,185,939 | $ | 1,910,501 | $ | 524,000 | $ | 41,000 | ||||||||||
|
Lender
|
Face Amount
|
Due Date
|
Interest
Rate
|
Description
On Balance Sheet
|
||||||||
|
Senior
subordinated convertible promissory notes
|
$ | 1,060,000 |
February
2013
|
— |
Senior
subordinated convertible promissory notes, net of discount (see Note
6)
|
|||||||
|
Promissory
note due to a related party
|
1,750,000 |
December
2012
|
6 | % |
Promissory
note due to a related party (see Note 5)
|
|||||||
|
Senior
subordinated convertible promissory notes
|
725,000 |
May
2013
|
— |
Senior
subordinated convertible promissory notes, net of discount (see Note
6)
|
||||||||
|
Convertible
notes payable
|
500,000 |
August
2014
|
6 | % |
Convertible
note payable(see Note 11)
|
|||||||
|
Total
|
$ | 4,035,000 | ||||||||||
|
·
|
Contribute expansion capital as
appropriate and available;
|
|
·
|
Increase operational
efficiency;
|
|
·
|
Leverage unique specialties and
areas of expertise of each Acquired
Business;
|
|
·
|
Create new revenue streams
through new service
offerings;
|
|
·
|
Leverage cost savings through
economies of scale;
|
|
·
|
Operate throughout the US and
subsequently embark upon a global expansion;
and
|
|
·
|
Carefully monitor the synergies
between the Acquired Businesses and nurture organic growth of their
businesses.
|
|
·
|
Purchase
Price
|
|
·
|
In total, (i) 25,031,253 shares
of Company Common Stock shall be issued to holders of MediSync Common
Stock, convertible notes and other indebtedness, (ii) warrants to purchase
2,090,000 shares of Company Common Stock shall be issued to holders of
MediSync warrants and (iii) options to purchase 1,010,250 shares of
Company Common Stock
shall be issued to holders of MediSync
options.
|
|
·
|
Board Seats: two
current MediSync directors shall be appointed to the Vyteris Board of
Directors.
|
|
·
|
Closing date: On or
about January 15, 2011.
|
|
Plan Category
|
(a)
Number of Securities to
be Issued Upon Exercise
of Outstanding Options,
Warrants and Rights
|
(b)
Weighted-Average
Exercise Price of
Outstanding Options,
Warrants
and Rights
|
(c)
Number of Securities Remaining
Available for Future Issuance
Under Equity Compensation Plans
(Excluding Securities
Reflected in Column (a))
|
|||||||||
|
Equity
Compensation Plans Approved by Stockholders:
|
||||||||||||
|
MediSync
Long Term Incentive Plan
|
- | $ | - | - | ||||||||
| MEDISYNC BIOSERVICES, INC. |
| (A Development Stage Company) |
|
CONTENTS
|
|
Report
of Independent Registered Public Accounting Firm
|
1
|
|
|
Financial
Statements
|
||
|
Balance
Sheets
|
2
|
|
|
Statements
of Operations
|
3
|
|
|
Statement
of Stockholders’ Deficiency
|
4
|
|
|
Statements
of Cash Flows
|
5-6
|
|
|
Notes
to Financial Statements
|
7-16
|


![]() |
1
|
| MEDISYNC BIOSERVICES, INC. |
| (A Development Stage Company) |
|
BALANCE
SHEETS
|
|
December 31,
|
2009
|
2008
|
||||||
|
ASSETS
|
||||||||
|
Current
assets
|
||||||||
|
Cash
|
$ | 14,454 | $ | 303,079 | ||||
|
Accounting
receivable
|
7,100 | |||||||
|
Total
current assets
|
21,554 | 303,079 | ||||||
|
Furniture
and equipment
|
25,057 | |||||||
|
Deposit
|
7,650 | |||||||
|
Total
assets
|
$ | 54,261 | $ | 303,079 | ||||
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIENCY
|
||||||||
|
Current
liabilities
|
||||||||
|
Accrued
liabilities
|
$ | 555,917 | $ | 327,555 | ||||
|
Notes
payable to directors (net of $90 and $0 original interest
discount)
|
74,910 | |||||||
|
Note
payable from acquisition of assets
|
43,000 | |||||||
|
Senior
subordinated convertible promissory notes (net of $2,193 original interest
discount and $75,428 debt issuance costs)
|
572,579 | |||||||
|
Total
current liabilities
|
1,246,406 | 327,555 | ||||||
|
Long-term
liabilities
|
||||||||
|
Notes
payable to directors (net of $60 and $0 original interest discount in 2009
and 2008, respectively)
|
52,940 | 53,000 | ||||||
|
Senior
subordinated convertible promissory notes (net of $5,168 original interest
discount and $177,775 debt issuance costs)
|
467,257 | |||||||
|
Total
long-term liabilities
|
52,940 | 520,257 | ||||||
|
STOCKHOLDERS’
DEFICIENCY
|
||||||||
|
Preferred
stock, par value $.0001, 10,000,000 shares authorized and 0 shares
outstanding
|
- | - | ||||||
|
Common
stock, par value $.0001, 50,000,000 shares authorized, 2,260,000 and
2,245,000 shares issued and outstanding at December 31, 2009 and 2008,
respectively
|
226 | 225 | ||||||
|
Additional
paid in capital
|
22,374 | 22,225 | ||||||
|
Deficit
accumulated during the development stage
|
(1,267,685 | ) | (567,183 | ) | ||||
|
Total
stockholders’ deficiency
|
(1,245,085 | ) | (544,733 | ) | ||||
|
Total
liabilities and stockholders’ deficiency
|
$ | 54,261 | $ | 303,079 | ||||
| See accompanying notes to financial statements. |
2
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
STATEMENTS
OF OPERATIONS
|
|
|
For the
Year Ended
December 31,
2009
|
For the
Year Ended
December 31,
2008
|
Period from
November 30,
2006
(date of inception)
to December 31,
2009
|
|||||||||
|
Revenues
|
$ | - | $ | - | $ | - | ||||||
|
Operating
expenses
|
||||||||||||
|
General
and administrative expenses
|
444,075 | 423,542 | 956,639 | |||||||||
|
Impairment
charge
|
110,843 | 110,843 | ||||||||||
|
Total
operating expenses
|
554,918 | 423,542 | 1,067,482 | |||||||||
|
Loss
from operations
|
(554,918 | ) | (423,542 | ) | (1,067,482 | ) | ||||||
|
Interest
expense
|
(145,584 | ) | (45,969 | ) | (200,203 | ) | ||||||
|
Net
loss
|
$ | (700,502 | ) | $ | (469,511 | ) | $ | (1,267,685 | ) | |||
|
Net loss per common share,
basic and diluted
|
$ | (0.31 | ) | $ | (0.65 | ) | $ | (1.32 | ) | |||
|
Weighted average number of
common shares outstanding, basic and diluted
|
2,245,697 | 717,064 | 958,883 | |||||||||
| See accompanying notes to financial statements. |
3
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
STATEMENT
OF STOCKHOLDERS DEFICIENCY
|
|
For
the period from November 30, 2006 (date of inception) to December 31,
2009
|
|
Common Stock
|
Additional
paid-in
|
Deficit
accumulated
during the
development
|
||||||||||||||||||
|
Shares
|
Amount
|
Capital
|
stage
|
Total
|
||||||||||||||||
|
Balance,
inception
|
-
|
$ | - | $ | - | $ | - | $ | - | |||||||||||
|
Net
loss, for the period November 30, 2006 to December 31,
2006
|
(48,000 | ) | (48,000 | ) | ||||||||||||||||
|
Balance,
December 31, 2006
|
(48,000 | ) | (48,000 | ) | ||||||||||||||||
|
Net
loss for 2007
|
(49,672 | ) | (49,672 | ) | ||||||||||||||||
|
Balance,
December 31, 2007
|
(97,672 | ) | (97,672 | ) | ||||||||||||||||
|
Issuance
of common stock in exchange for services
|
1,100,000 | 110 | 10,890 | 11,000 | ||||||||||||||||
|
Issuance
of common stock with Convertible Notes
|
595,000 | 60 | 5,890 | 5,950 | ||||||||||||||||
|
Issuance
of common stock to placement agent
|
550,000 | 55 | 5,445 | 5,500 | ||||||||||||||||
|
Net
loss for 2008
|
(469,511 | ) | (469,511 | ) | ||||||||||||||||
|
Balance,
December 31, 2008
|
2,245,000 | 225 | 22,225 | (567,183 | ) | (544,733 | ) | |||||||||||||
|
Issuance
of common stock with Bridge Notes
|
15,000 | 1 | 149 | 150 | ||||||||||||||||
|
Net
loss for 2009
|
(700,502 | ) | (700,502 | ) | ||||||||||||||||
|
Balance,
December 31, 2009
|
2,260,000 | $ | 226 | $ | 22,374 | $ | (1,267,685 | ) | $ | (1,245,085 | ) | |||||||||
| See accompanying notes to financial statements. |
4
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
STATEMENT
OF CASH FLOWS
|
|
|
For the
Year Ended
December 31,
2009
|
For the
Year Ended
December 31,
2008
|
Period from
November 30,
2006
(date of inception)
to December 31,
2009
|
|||||||||
|
Cash
flows from operating activities
|
||||||||||||
|
Net
loss
|
$ | (700,502 | ) | $ | (469,511 | ) | $ | (1,267,685 | ) | |||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
|
Impairment
charge
|
110,843 | 110,843 | ||||||||||
|
Amortization
of discount on convertible debt
|
2,975 | 782 | 3,757 | |||||||||
|
Amortization
of deferred debt issuance cost
|
102,347 | 26,919 | 129,266 | |||||||||
|
Issuance
of common stock in exchange for services
|
11,000 | 11,000 | ||||||||||
|
Increase
in cash attributable to changes in operating assets and
liabilities:
|
||||||||||||
|
Accrued
liabilities
|
228,362 | 298,411 | 535,423 | |||||||||
|
Net
cash used in operating activities
|
(255,975 | ) | (132,399 | ) | (477,396 | ) | ||||||
|
Cash
flows from investing activities
|
||||||||||||
|
Purchase
of Mountain West assets
|
(100,000 | ) | (100,000 | ) | ||||||||
|
Payment
of deposit
|
(7,650 | ) | (7,650 | ) | ||||||||
|
Net
cash used in investing activities
|
(107,650 | ) | (107,650 | ) | ||||||||
|
Cash
flows from financing activities
|
||||||||||||
|
Proceeds
from notes payable
|
75,000 | 40,000 | 213,000 | |||||||||
|
Proceeds
from issuance of Senior subordinated convertible promissory
notes
|
550,000 | 550,000 | ||||||||||
|
Payment
of debt issuance costs
|
(163,500 | ) | (163,500 | ) | ||||||||
|
Net
cash provided by financing activities
|
75,000 | 426,500 | 599,500 | |||||||||
|
Net
increase (decrease) in cash
|
(288,625 | ) | 294,101 | 14,454 | ||||||||
|
Cash, beginning of
period
|
303,079 | 8,978 | ||||||||||
|
Cash, end of
period
|
$ | 14,454 | $ | 303,079 | $ | 14,454 | ||||||
| See accompanying notes to financial statements. |
5
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
STATEMENT
OF CASH FLOWS (continued)
|
|
For the
Year
Ended
December 31,
2009
|
For the
Year
Ended
December 31,
2008
|
Period from
November 30,
2006
(date of inception)
to December 31,
2009
|
||||||||||
|
Supplemental
disclosures of non-cash financing and investing
activities:
|
||||||||||||
|
Note
payable issued in connection with the acquisition of
assets
|
$ | 43,000 | $ | - | $ | 43,000 | ||||||
|
Accrued
debt issuance costs
|
$ | - | $ | 35,694 | $ | 35,694 | ||||||
|
Issuance
of common stock to placement agent
|
$ | - | $ | 5,500 | $ | 5,500 | ||||||
|
Conversion
of notes payable to senior subordinated convertible promissory
notes
|
$ | - | $ | 90,000 | $ | 90,000 | ||||||
|
Accrued
interest converted to notes payable
|
$ | - | $ | 5,000 | $ | 5,000 | ||||||
|
Accrued
interest converted to senior subordinated convertible promissory
notes
|
$ | - | $ | 10,200 | $ | 10,200 | ||||||
| See accompanying notes to financial statements. |
6
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
Balance,
December 31, 2008
|
$ | - | |||
|
Goodwill
from Acquisition of Mountain West
|
110,843 | ||||
|
Impairment
charge
|
(110,843 | ) | |||
|
Balance,
December 31, 2009
|
$ | - |
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
2009
|
2008
|
|||||||
|
Accrued
legal and consulting fees
|
$ | 443,672 | $ | 302,172 | ||||
|
Accrued
interest
|
53,580 | 11,718 | ||||||
|
Other
|
58,665 | 13,665 | ||||||
| $ | 555,917 | $ | 327,555 | |||||
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
2009
|
2008
|
|||||||
|
Statutory
U.S. rate
|
34 | % | 34 | % | ||||
|
State
income taxes, net of federal benefit
|
6 | 6 | ||||||
|
Effect
of allowance
|
(40 | ) | (40 | ) | ||||
|
Total
income tax expense (benefit)
|
0 | % | 0 | % | ||||
|
MEDISYNC BIOSERVICES,
INC.
|
|
(A
Development Stage Company)
|
|
NOTES
TO FINANCIAL STATEMENTS
|
|
Accounts
receivable
|
$ | 7,100 | ||
|
Furniture
and equipment
|
25,057 | |||
|
Goodwill
|
110,843 | |||
| $ | 143,000 |
|
September 30,
|
December 31,
|
|||||||
|
2010
|
2009
|
|||||||
|
ASSETS
|
(Unaudited)
|
|||||||
|
Current
assets:
|
||||||||
|
Cash
|
$ | 91,112 | $ | 14,454 | ||||
|
Accounts
receivable
|
8,000 | 7,100 | ||||||
|
Total
current assets
|
99,112 | 21,554 | ||||||
|
Furniture
and equipment, net
|
24,705 | 25,057 | ||||||
|
Deposits
|
33,130 | 7,650 | ||||||
|
Total
assets
|
$ | 156,947 | $ | 54,261 | ||||
|
LIABILITIES
AND STOCKHOLDERS’ DEFICIENCY
|
||||||||
|
Current
liabilities:
|
||||||||
|
Accounts
payable and accrued expenses
|
$ | 1,211,199 | $ | 555,917 | ||||
|
Notes
payable to directors
|
53,000 | 74,910 | ||||||
|
Note
payable from acquisition of assets
|
43,000 | 43,000 | ||||||
|
Senior
subordinated convertible promissory notes (net of $0 and $2,193 original
interest discount and $0 and $75,428 debt issuance costs at September 30,
2010 and December 31, 2009, respectively)
|
1,354,005 | 572,579 | ||||||
|
Total
current liabilities
|
2,661,204 | 1,246,406 | ||||||
|
Long-term
liabilities:
|
||||||||
|
Notes
payable to directors
|
— | 52,940 | ||||||
|
Total
long-term liabilities
|
— | 52,940 | ||||||
|
STOCKHOLDERS’
DEFICIENCY
|
||||||||
|
Preferred
stock, par value $.0001, 10,000,000 shares authorized and 0 shares
outstanding
|
— | — | ||||||
|
Common
stock, par value $.0001, 50,000,000 shares
authorized, 2,989,805
and 2,260,000 shares issued and outstanding at September 30, 2010 and
December 31, 2009, respectively
|
299 | 226 | ||||||
|
Additional
paid in capital
|
29,339 | 22,374 | ||||||
|
Deficit
accumulated during the development stage
|
(2,533,895 | ) | (1,267,685 | ) | ||||
|
Total
stockholders’ deficiency
|
(2,504,257 | ) | (1,245,085 | ) | ||||
|
Total
liabilities and stockholders’ deficiency
|
$ | 156,947 | $ | 54,261 | ||||
|
For
the Nine Months Ended
September
30,
|
Period
from
November
30, 2006
(date
of inception)
to
September 30,
|
|||||||||||
|
2010
|
2009
|
2010
|
||||||||||
|
Revenues
|
$ | 53,855 | $ | - | $ | 53,855 | ||||||
|
Cost
of Revenue
|
27,310 | - | 27,310 | |||||||||
|
Gross
Margin
|
26,545 | - | 26,545 | |||||||||
|
Operating
expenses
|
||||||||||||
|
General
and administrative expenses
|
1,089,731 | 299,491 | 2,046,370 | |||||||||
|
Impairment
charge
|
- | - | 110,843 | |||||||||
|
Total
operating expenses
|
1,089,731 | 299,491 | 2,157,213 | |||||||||
|
Loss
from operations
|
(1,063,186 | ) | (299,491 | ) | (2,130,668 | ) | ||||||
|
Interest
expense
|
(203,024 | ) | (109,163 | ) | (403,227 | ) | ||||||
|
Net
loss
|
$ | (1,266,210 | ) | $ | (408,654 | ) | $ | (2,533,895 | ) | |||
|
Net loss per common share,
basic and diluted
|
$ | (0.48 | ) | $ | (0.18 | ) | $ | (1.96 | ) | |||
|
Weighted average number of
common shares outstanding, basic and diluted
|
2,638,598 | 2,246,313 | 1,295,972 | |||||||||
|
For
the Nine Months Ended
September
30,
|
Period
from
November
30, 2006
(date
of inception)
to
September 30,
|
|||||||||||
|
2010
|
2009
|
2010
|
||||||||||
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||
|
Net
loss
|
$ | (1,266,210 | ) | $ | (408,654 | ) | $ | (2,533,895 | ) | |||
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
|
Impairment
charge
|
-— | -— | 110,843 | |||||||||
|
Amortization
of original discount on convertible debt
|
2,193 | 2,225 | 5,950 | |||||||||
|
Amortization
of debt issuance cost
|
75,428 | 76,550 | 204,694 | |||||||||
|
Depreciation
expense
|
352 | -— | 352 | |||||||||
|
Issuance
of common stock in exchange for services
|
-— | -— | 11,000 | |||||||||
|
Increase
(decrease) in cash attributable to changes in operating assets and
liabilities, net of assets and liabilities acquired:
|
||||||||||||
|
Accounts
receivable
|
(900 | ) | -— | (900 | ) | |||||||
|
Accounts
payable and accrued liabilities
|
666,275 | 139,364 | 1,201,698 | |||||||||
|
NET
CASH USED IN OPERATING ACTIVITIES
|
(522,862 | ) | (190,515 | ) | (1,000,258 | ) | ||||||
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||
|
Purchase
of Mountain West assets
|
-— | -— | (100,000 | ) | ||||||||
|
Payment
deposit
|
(25,480 | ) | — | ( 33,130 | ) | |||||||
|
NET
CASH USED IN INVESTING ACTIVITIES
|
(25,480 | ) | -— | (133,130 | ) | |||||||
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||
|
Proceeds
from notes payable
|
-— | -— | 213,000 | |||||||||
|
Proceeds
from issuance of senior subordinate convertible promissory
notes
|
625,000 | -— | 1,175,000 | |||||||||
|
Payment
of the debt issuance costs
|
-— | -— | (163,500 | ) | ||||||||
|
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
625,000 | -— | 1,224,500 | |||||||||
|
INCREASE
(DECREASE ) IN CASH
|
76,658 | (190,515 | ) | 91,112 | ||||||||
|
CASH
- BEGINNING OF PERIOD
|
14,454 | 303,079 | -— | |||||||||
|
CASH
- END OF PERIOD
|
$ | 91,112 | $ | 112,564 | $ | 91,112 | ||||||
|
Supplemental
disclosures of non cash financing activities:
|
||||||||||||
|
Accrued
debt issuance costs
|
$ | 62,750 | — | $ | 62,750 | |||||||
|
Conversion
of notes payable to senior subordinated convertible promissory
notes
|
$ | (75,000 | ) | — | $ | (75,000 | ) | |||||
|
Accrued
interest converted to senior subordinated convertible promissory
notes
|
$ | 3,805 | — | $ | 3,805 | |||||||
|
Accounts
receivable................................
|
$ | 7,100 | ||
|
Furniture
and equipment........................
|
25,057 | |||
|
Goodwill………………….....................
|
110,843 | |||
| $ | 143,000 |
|
|
||||
|
Balance,
December 31, 2008.........................................
|
$ | - | ||
|
Goodwill
from Acquisition of Mountain West.............
|
110,843 | |||
|
Impairment
charge.........................................................
|
(110,843 | ) | ||
|
Balance,
December 31, 2009.........................................
|
$ | - | ||
|
September
30,
|
December
31,
|
|||||||
|
2010
|
2009
|
|||||||
|
Accrued
legal and consulting fees
|
$ | 1,027,774 | $ | 443,672 | ||||
|
Accrued
interest
|
105,314 | 53,580 | ||||||
|
Other
|
78,111 | 58,665 | ||||||
|
Accounts
payable and accrued liabilities
|
$ | 1,211,199 | $ | 555,917 | ||||
|
·
|
To
the holders of Company common stock, five shares of Vyteris’ common stock
for each share of Company’s common
stock.
|
|
·
|
To
the holders of convertible notes and other indebtedness of Company, five
shares of the Vyteris’ common stock for each $1.00 of Company
debt.
|
|
·
|
To
the holders of Company warrants, warrants to purchase five shares of
Vyteris’ common stock, at a $0.20 exercise price, for each
warrant to purchase (i) a share of Company common stock and (ii) $1 of
convertible note to be issued by
Company.
|
|
·
|
To
the holders of Company options, options to purchase five shares of
Vyteris’ common stock for each option to purchase a share of Company
common stock.
|
|
·
|
$4,250,000
in cash,
|
|
·
|
$950,000
in promissory notes, and
|
|
·
|
Vyteris
common stock valued at $750,000.
|
|
·
|
year
1 - $1,250,000,
|
|
·
|
year
2 - $1,437,000; and
|
|
·
|
year
3 - 1,625,000.
|
|
·
|
Contribute
expansion capital as appropriate and
available;
|
|
·
|
Increase
operational efficiency;
|
|
·
|
Leverage
unique specialties and areas of expertise of each Acquired
Business;
|
|
·
|
Create
new revenue streams through new service
offerings;
|
|
·
|
Leverage
cost savings through economies of scale;
|
|
|
·
|
Operate
throughout the US and subsequently embark upon a global expansion;
and
|
|
·
|
Carefully
monitor the synergies between the Acquired Businesses and nurture organic
growth of their businesses.
|
|
·
|
Purchase
Price
|
|
·
|
In
total, (i) 25,031,253 shares of Company Common Stock shall be issued to
holders of MediSync Common Stock, convertible notes and other
indebtedness, (ii) warrants to purchase 2,090,000 shares of Company Common
Stock shall be issued to holders of MediSync warrants and (iii) options to
purchase 1,010,250 shares of Company Common Stock shall be issued to
holders of MediSync options.
|
|
·
|
Board
Seats: two current MediSync directors shall be appointed to the
Vyteris Board of Directors.
|
|
|
·
|
Closing
date: On or about February 15,
2011.
|
|
·
|
$4,250,000
in cash,
|
|
·
|
$950,000
in promissory notes, and
|
|
·
|
Vyteris
common stock valued at $750,000.
|
|
·
|
year
1 - $1,250,000,
|
|
·
|
year
2 - $1,437,000; and
|
|
·
|
year
3 - 1,625,000.
|
|
Vyteris, Inc.
|
MediSync
BioServices Inc.
|
Pro
forma
Adjustments
|
Pro forma
|
|||||||||||||||||
|
ASSETS
|
||||||||||||||||||||
|
Current
Assets
|
||||||||||||||||||||
|
Cash
|
$ | 1,153,819 | $ | 91,112 | $ | - | $ | 1,244,931 | ||||||||||||
|
Accounts
receivable
|
- | 8,000 | - | 8,000 | ||||||||||||||||
|
Other
current assets
|
110,765 | - | - | 110,765 | ||||||||||||||||
|
Total
current assets
|
1,264,584 | 99,112 | - | 1,363,696 | ||||||||||||||||
|
Property
and Equipment & Other Assets
|
||||||||||||||||||||
|
Debt
issuance costs, net
|
2,044,421 | - | - | 2,044,421 | ||||||||||||||||
|
Property
and equipment , net
|
27,799 | 24,705 | - | 52,504 | ||||||||||||||||
|
Other
assets
|
290,352 | 33,130 | - | 323,482 | ||||||||||||||||
|
Intangibles,
contractual rights
|
- | - | 7,891,799 | d | 7,891,799 | |||||||||||||||
|
Total
Assets
|
$ | 3,627,156 | $ | 156,947 | $ | 7,891,799 | $ | 11,675,902 | ||||||||||||
|
LIABILITIES
AND EQUITY
|
||||||||||||||||||||
|
Current
Liabilities
|
||||||||||||||||||||
|
Accounts
payable & accrued liabilities
|
$ | 2,219,249 | $ | 1,211,199 | $ | (105,314 | )- | a | $ | 3,325,134 | ||||||||||
|
Fair
value of derivative financial statements
|
10,180,233 | - | - | 10,180,233 | ||||||||||||||||
|
Notes
payable
|
- | 53,000 | - | 53,000 | ||||||||||||||||
|
Note
payable from acquisition of assets
|
- | 43,000 | - | 43,000 | ||||||||||||||||
|
Accrued
expenses & other
|
3,508,350 | - | - | 3,508,350 | ||||||||||||||||
|
Senior
secured convertible promissory notes
|
- | 1,354,005 | (1,354,005 | ) | a | - | ||||||||||||||
|
Interest
payable and accrued expenses due to
related
party
|
190,093 | - | - | 190,093 | ||||||||||||||||
|
Total
current liabilities
|
16,097,925 | 2,661,204 | (1,459,319 | ) | 17,299,810 | |||||||||||||||
|
Other
Liabilities
|
||||||||||||||||||||
|
Promissory
note due related party
|
1,750,000 | - | - | 1,750,000 | ||||||||||||||||
|
Senior
subordinated convertible promissory notes,
net
of discount
|
26,859 | - | - | 26,859 | ||||||||||||||||
|
Deferred
revenue and other
|
746,237 | - | - | 746,237 | ||||||||||||||||
|
Convertible
note
|
500,000 | - | - | 500,000 | ||||||||||||||||
|
Total
other liabilities
|
3,023,096 | - | - | 3,023,096 | ||||||||||||||||
|
Total
Liabilities
|
$ | 19,121,021 | $ | 2,661,204 | $ | (1,459,319 | ) | $ | 20,322,906 | |||||||||||
|
Vyteris, Inc.
|
MediSync
BioServices Inc.
|
Pro
forma
Adjustments
|
Pro forma
|
|||||||||||||||||
|
EQUITY
|
||||||||||||||||||||
|
Stockholders'
equity
|
||||||||||||||||||||
|
Stockholders'
equity (deficit):
|
$ | 1,031,326 | $ | 299 | $ | (299 | ) |
b
|
$ | 1,406,795 | ||||||||||
| 375,469 |
c
|
|||||||||||||||||||
|
Additional
paid in capital
|
213,139,437 | 29,339 | (29,339 | ) | b | 219,610,829 | ||||||||||||||
| 5,882,344 | c | |||||||||||||||||||
| 589,048 | e | |||||||||||||||||||
|
Accumulated
deficit
|
(229,664,628 | ) | (2,533,895 | ) | 2,533,895 | b | (229,664,628 | ) | ||||||||||||
|
Total
stockholders' equity
|
(15,493,865 | ) | (2,504,257 | ) | 9,351,118 | (8,647,004 | ) | |||||||||||||
|
Total
Liabilities and Stockholders’ Equity
|
$ | 3,627,156 | $ | 156,947 | $ | 7,891,799 | $ | 11,675,902 | ||||||||||||
|
Vyteris, Inc.
|
MediSync
BioServices Inc.
|
Pro
forma
Adjustments
|
Pro forma
|
|||||||||||||||||
|
Revenues
|
$ | 141,533 | $ | 53,855 | $ | - | $ | 195,388 | ||||||||||||
|
Cost
of sales
|
- | 27,310 | - | 27,310 | ||||||||||||||||
|
Gross
margin
|
141,533 | 26,545 | - | 168,078 | ||||||||||||||||
|
Operating
Expenses
|
||||||||||||||||||||
|
Research
and development
|
2,083,087 | - | - | 2,083,087 | ||||||||||||||||
|
General
and administrative
|
4,283,243 | 1,089,731 | - | 5,372,974 | ||||||||||||||||
|
Total
general and administrative
|
6,366,330 | 1,089,731 | - | 7,456,061 | ||||||||||||||||
| , | ||||||||||||||||||||
|
Loss
from Operations Before Other Expenses and Taxes
|
(6,224,797 | ) | (1,063,186 | ) | - | (7,287,983 | ) | |||||||||||||
|
Interest
(Income) Expenses
|
||||||||||||||||||||
|
Interest
(income) expense – net
|
(1,182 | ) | - | - | (1,182 | ) | ||||||||||||||
|
Interest
expense to related parties
|
449,029 | 203,024 | (200,639 | ) | a | 451,414 | ||||||||||||||
|
Interest
expense
|
29,367 | - | - | 29,367 | ||||||||||||||||
|
Non-cash
interest expense for warrants
issued
on induced conversion of debt
|
2,832,706 | - | - | 2,832,706 | ||||||||||||||||
|
Non
cash interest expense for warrants
issued
to investors
|
485,029 | - | - | 485,029 | ||||||||||||||||
|
Total
interest expense (income), net
|
3,794,949 | 203,024 | (200,639 | ) | 3,797,334 | |||||||||||||||
|
Other
(Income) Expenses
|
||||||||||||||||||||
|
Increase
in fair value of derivative financial
Instruments
|
5,313,661 | - | - | 5,313,661 | ||||||||||||||||
|
Total
other expenses
|
5,313,661 | - | - | 5,313,661 | ||||||||||||||||
|
Net
Loss
|
$ | (15,333,407 | ) | $ | (1,266,210 | ) | $ | (200,639 | ) | $ | (16,398,978 | ) | ||||||||
|
Net
Loss per Common Share
|
||||||||||||||||||||
|
Basic
and diluted loss per share
|
$ | (0.24 | ) | $ | (0.19 | ) | ||||||||||||||
|
Common
shares outstanding
|
- | 2,989,805 | (2,989,805 | ) | b | - | ||||||||||||||
|
Weighted
average common shares
outstanding
|
62,716,803 | - | 25,031,253 | c | 87,748,056 | |||||||||||||||
|
Vyteris, Inc.
|
MediSync
BioServices Inc.
|
Pro
forma
Adjustments
|
Pro forma
|
|||||||||||||||||
|
Revenues
|
$ | 4,560,709 | $ | - | $ | - | $ | 4,560,709 | ||||||||||||
|
General
and Administrative
|
||||||||||||||||||||
|
Research
and development
|
2,895,691 | - | - | 2,895,691 | ||||||||||||||||
|
General
and administrative including
(credit)
for reversal of performance-
based
stock option grants of ($6.1)
million
in 2008
|
2,796,763 | 444,075 | 100,000 | f | 3,340,838 | |||||||||||||||
|
Facility
realignment and impairment
Charges
|
177,831 | 110,843 | - | 288,674 | ||||||||||||||||
|
Amortization
of intangible assets
|
- | - | 7,891,799 | d | 7,891,799 | |||||||||||||||
|
Registration
rights penalty
|
215,988 | - | - | 215,988 | ||||||||||||||||
|
Total
general and administrative
|
6,086,273 | 554,918 | 7,991,799 | 14,632,990 | ||||||||||||||||
|
Earnings
(Loss) Before Other Expenses
and
Taxes
|
(1,525,564 | ) | (554,918 | ) | (7,991,799 | ) | (10,072,281 | ) | ||||||||||||
|
Interest
(Income) Expenses
|
||||||||||||||||||||
|
Interest
(income) expense – net
|
(552 | ) | - | - | (552 | ) | ||||||||||||||
|
Interest
expense to related parties
|
1,451,728 | 145,584 | (142,404 | ) | a | 1,454,908 | ||||||||||||||
|
Interest
expense
|
169,610 | - | - | 169,610 | ||||||||||||||||
|
Total
interest expense, net
|
1,620,786 | 145,584 | (142,404 | ) | 1,623,966 | |||||||||||||||
|
Other
(Income) Expenses
|
||||||||||||||||||||
|
Gain
on settlement of lease obligations
|
(1,953,977 | ) | - | - | (1,953,977 | ) | ||||||||||||||
|
Gain
on settlement of registration
rights
penalty
|
(1,385,017 | ) | - | - | (1,385,017 | ) | ||||||||||||||
|
Net
non cash debt extinguishment
|
35,909,507 | - | - | 35,909,507 | ||||||||||||||||
|
Revaluation
of warrant liability
|
294,668 | - | - | 294,668 | ||||||||||||||||
|
Total
other expenses
|
32,865,181 | - | - | 32,865,181 | ||||||||||||||||
|
Loss
Before Benefit from State
Income
Taxes
|
(36,011,531 | ) | (700,502 | ) | (7,849,395 | ) | (44,561,428 | ) | ||||||||||||
|
Sale
of State of New Jersey Net
Operating
Losses
|
2,071,168 | - | - | 2,071,168 | ||||||||||||||||
|
Net
Loss
|
$ | (33,940,363 | ) | $ | (700,502 | ) | $ | (7,849,395 | ) | $ | (42,490,260 | ) | ||||||||
|
Net
Loss per Common Share
|
||||||||||||||||||||
|
Basic
and diluted loss per share
|
$ | (3.77 | ) | $ | (1.25 | ) | ||||||||||||||
|
Common
shares outstanding
|
- | 2,260,000 | (2,260,000 | ) | b | - | ||||||||||||||
|
Weighted
average common shares
Outstanding
|
9,002,816 | - | 25,031,253 | c | 34,034,069 | |||||||||||||||
|
·
|
A
closing price of Vyteris' common stock of $0.25 on January 19, 2011, the
preliminary aggregate purchase price was approximately
$6,846,861. Based on the stability of the nature of Vyteris’
operations in the current marketplace, the fair value of the January 19,
2011 consideration was deemed to be representative of the current market
value.
|
|
·
|
The
fair value of stock-based awards was estimated using the
Black-Scholes-Merton model, or in the case of awards with market or
performance based conditions, the binomial model, with the following
weighted-average assumptions for stock options as of January 19, 2011: (i)
per share closing stock price of $0.25; (ii) expected holding period (in
years) – 5; (iii) risk free interest rate – 1.95%; (iv) dividend yield –
0%; (v) calculation of per share fair value of options and warrants
granted - $0.19; (vi) expected volatility – 91.86%; and (vii) option
forfeiture rate – 14.4%.
|
|
Fair
value of Vyteris common stock issued
|
$ | 6,257,813 | ||
|
Fair
value of MediSync warrants and options replaced
|
589,048 | |||
|
Total
preliminary estimated purchase price
|
$ | 6,846,861 |
|
·
|
To
the holders of MediSync Common Stock, five (5) shares of Vyteris Common
Stock for each share of MediSync Common
Stock.
|
|
·
|
To
the holders of convertible notes and other indebtedness of MediSync, five
(5) shares of Vyteris Common Stock for each $1.00 of MediSync
debt.
|
|
·
|
To
the holders of MediSync warrants, warrants to purchase five (5) shares of
Vyteris Common Stock, at a $0.20 exercise price, for each warrant to
purchase (i) a share of MediSync Common Stock and (ii) $1.00 of
convertible note issued by
MediSync.
|
|
·
|
To
the holders of MediSync options, options to purchase five (5) shares of
Vyteris Common Stock for each option to purchase a share of MediSync
Common Stock.
|
|
Assets:
|
||||
|
Current
Assets
|
$ | 99,112 | ||
|
Property
and Equipment & Other
|
57,835 | |||
|
Intangible
Asset, Contractual Rights
|
7,891,799 | |||
|
Total
Assets Acquired
|
$ | 8,048,746 | ||
|
Liabilities:
|
||||
|
Current
Liabilities
|
$ | 1,201,885 | ||
|
Total
Liabilities Assumed
|
$ | 1,201,885 | ||
|
Net
Assets Acquired
|
$ | 6,846,861 | ||
|
Total
Preliminary Estimated Purchase Price
|
$ | 6,846,861 | ||
|
a.
|
To
eliminate the convertible notes converted into 10,082,228 shares of
Vyteris’ common stock and the related interest expense on the convertible
notes. The 10,082,228 shares of Vyteris’ common stock are
included in total amount of shares exchanged to consummate the
acquisition.
|
|
b.
|
To
eliminate MediSync's historical shareholders' equity
accounts.
|
|
c.
|
To
record the fair value of 25,031,253 shares of Vyteris’ common stock
exchanged in the acquisition.
|
|
d.
|
To
record the acquired intangible asset which represents the contractual
rights to acquire the future cash flows of a target acquisition with a
definitive agreement in place. Additional contractual and non
contractual relationships were considered of value, but are not recorded
in this intangible asset. Due to the nature of the contracts, we believe
this asset to have a life of twelve months, which is considered in the
amortization life in the 2009 pro forma adjustments on the statements of
operations.
|
|
e.
|
To
record the fair value of the MediSync’s warrants and options replaced that
related to pre-acquisition service.
|
|
f.
|
To
record the estimated transaction costs in
2009.
|