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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE
SECURITIES EXCHANGE ACT OF 1934
For the
quarterly period ended September 30, 2010
OR
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission
File Number 000-32741
Vyteris,
Inc.
(Exact
name of issuer as specified in its charter)
|
NEVADA
|
84-1394211
|
|
(State
or other jurisdiction
|
(I.R.S.
Employer
|
|
of
incorporation or organization)
|
Identification
No.)
|
|
|
|
|
13-01
POLLITT DRIVE
|
|
|
FAIR
LAWN, NEW JERSEY
|
07410
|
|
(Address
of principal executive office)
|
(Zip
Code)
|
(201)
703-2299
(Issuer’s
telephone number)
Indicate
by check mark whether the registrant: (1) filed all reports required to be filed
by Section 13 or 15(d) of the Exchange Act during the past twelve months (or for
such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90
days.
YES x NO ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,”
“accelerated filer” and “smaller reporting company” in Rule 12b-2 of the
Exchange Act.
|
Large
accelerated filer ¨
|
Accelerated
filer ¨
|
|
Non-accelerated
filer (Do not check if a smaller reporting company) ¨
|
Smaller
reporting company x
|
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate website, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit and post such
files). Yes ¨ No
¨
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act). YES ¨ NO x
State the
number of shares outstanding of each of the issuer’s classes of common equity,
as of the latest practicable date.
|
CLASS
|
|
OUTSTANDING
AT NOVEMBER 8, 2010
|
|
Common
stock, par value $0.015 share
|
|
68,755,067
|
VYTERIS, INC.
FORM
10-Q
INDEX
|
|
|
Page
No.
|
|
PART
I
|
FINANCIAL
INFORMATION
|
3
|
|
|
|
|
|
|
|
Item
1.
|
Financial
Statements:
|
3
|
|
|
|
|
|
|
|
|
Condensed
Consolidated Balance Sheets as of September 30, 2010
(Unaudited)
and
December 31, 2009
|
3
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Operations for the Three and Nine
Months ended September 30, 2010 and 2009
|
4
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for
the
Nine
Months ended September 30, 2010
|
5
|
|
|
|
|
|
|
|
|
Unaudited
Condensed Consolidated Statements of Cash Flows for the Nine Months
ended September 30, 2010 and 2009
|
6
|
|
|
|
|
|
|
|
|
Notes
to Unaudited Condensed Consolidated Financial
Statements
|
7
|
|
|
|
|
|
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Plan of
Operations
|
19
|
|
|
|
|
|
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
31
|
|
|
|
|
|
|
|
Item
4.
|
Controls
and Procedures
|
32
|
|
|
|
|
|
|
|
PART
II
|
OTHER
INFORMATION
|
33
|
|
|
|
|
|
|
|
Item
1.
|
Legal
Proceedings
|
33
|
|
|
|
|
|
|
|
Item
1A.
|
Risk
Factors
|
33
|
|
|
|
|
|
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
36
|
|
|
|
|
|
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
36
|
|
|
|
|
|
|
|
Item
5.
|
Other
Information
|
36
|
|
|
|
|
|
|
|
Item
6.
|
Exhibits
|
36
|
|
|
|
|
|
|
Signature
|
36
|
|
Vyteris®
and LidoSite® are our trademarks. All other trademarks, servicemarks or trade
names referred to in this Quarterly Report on Form 10-Q are the property of
their respective owners.
ITEM
1. FINANCIAL STATEMENTS
VYTERIS
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
|
|
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 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
VYTERIS,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
|
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 |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
VYTERIS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(UNAUDITED)
|
|
|
|
|
|
|
|
|
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 |
) |
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
VYTERIS,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
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 |
|
|
|
— |
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
|
1.
|
Liquidity and Basis of
Presentation
|
The
accompanying condensed consolidated financial statements have been prepared
assuming that Vyteris, Inc. (the terms “Vyteris” and the “Company”
refer to each of Vyteris, Inc., its subsidiary, Vyteris, Inc.
(incorporated in the State of Delaware) and the consolidated entity) will
continue as a going concern.
In
December 2009, the Company converted $20.3 million of secured indebtedness and
preferred stock into common stock of the Company, as well as received a net cash
payment of $2.1 million from the sale of the Company’s State of New Jersey net
operating losses. In February and May 2010, the Company raised $1.8
million through the sale of senior subordinated convertible promissory notes and
in June 2010, the Company raised $1.2 million through the sale of short term
subordinated convertible promissory notes. Nonetheless, subsequent financings
will be required to fund the Company’s operations, fund research and development
for new products, repay past due payables and pay debt service
requirements.
Spencer
Trask Specialty Group and affiliates (“STSG”) owns 75.6% of the issued and
outstanding common stock of the Company as of September 30, 2010. Due to this
stock ownership, the Company is controlled by STSG and is deemed a “controlled
corporation”. STSG may influence the Company to take actions that conflict with
the interests of other shareholders.
In
December 2009, Ferring Pharmaceuticals, Inc. (“Ferring”) terminated its License
and Development Agreement, dated September 27, 2004 under Section 9.04 thereof
with the Company and thus discontinued its collaborative effort for their joint
infertility project. The Company has commenced litigation against Ferring with
regard to the termination of the License Agreement and disposition of remaining
matters.
No
assurance can be given that the Company will be successful in procuring the
further financing needed to continue the execution of its business plan, which
includes the development of new products. Failure to obtain such financing would
require management to substantially curtail, if not cease, operations, which
would result in a material adverse effect on the financial condition and results
of operations of the Company. These conditions raise substantial doubt about the
Company’s ability to continue as a going concern. The report of the independent
registered public accounting firm relating to the audit of the Company's
consolidated financial statements for the year ended December 31, 2009 contains
an explanatory paragraph expressing uncertainty regarding the Company’s ability
to continue as a going concern because of its operating losses and its
continuing need for additional capital in order to continue operations. The
condensed consolidated financial statements do not include any adjustments to
reflect the possible future effects on the recoverability and classification of
assets or the amounts and classification of liabilities that might occur if the
Company is unable to continue in business as a going concern.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been
prepared in accordance with U.S. generally accepted accounting principles for
interim financial information and with the instructions to Form 10-Q and Article
8-03 of Regulation S-X. Accordingly, they do not include all of the information
and footnotes required by U.S. generally accepted accounting principles for
complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary for a fair
presentation have been included. These condensed consolidated financial
statements should be read in conjunction with the audited consolidated financial
statements included in the Company's Annual Report on Form 10-K for the year
ended December 31, 2009. The condensed consolidated balance sheet as of December
31, 2009 has been derived from those audited consolidated financial statements.
Operating results for the three and nine month periods ended September 30, 2010
are not necessarily indicative of the results that may be expected for the year
ending December 31, 2010. All significant intercompany balances and transactions
have been eliminated in consolidation.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
Business
The
Company developed and produced the first FDA-approved electronically controlled
transdermal drug delivery system that delivers drugs through the skin
comfortably, without needles. This platform technology can potentially be used
to administer a wide variety of therapeutics either directly into the skin or
into the bloodstream. The Company holds U.S. and foreign patents relating to the
delivery of drugs across the skin using an electronically controlled “smart
patch” device with electric current. Given the termination of the September 27,
2004 Ferring agreement, the Company is not currently engagement in any material
collaborative development projects; however, the Company is currently seeking
collaborative partners for several of its projects.
Merger
Agreement
In
September 2010 our Board of Directors approved an Agreement and Plan of Merger
(the “Merger Agreement”) by and among MediSync BioServices, Inc., a Delaware
corporation (“MediSync”), Vyteris and a newly created subsidiary of the Company
(“Merger Sub“), pursuant to which the Merger Sub will be merged with and into
MediSync, with MediSync continuing as the surviving corporation and a
wholly-owned subsidiary of Vyteris (the “Merger”). As of early November 2010, we
have received requisite shareholder approval to consummate the Merger, and the
Merger will close upon completion of the information statement to shareholders
pursuant to Section 14(c) process and filing of the certificates of merger in
the State of Delaware. MediSync is in the business of consolidating
preclinical and contract research organizations (“CROs”) and related businesses,
including site management organizations (“SMOs”), which sub-contract clinical
trial-related responsibilities from a CRO or pharmaceutical/biotechnology
company, and post marketing surveillance companies, which monitor pharmaceutical
drugs and devices after release into the market. MediSync believes that its
future operations may provide added value to the pharmaceutical and
biotechnology industries as a valuable outsource service to them. The
CRO business model is expected to provide cash flow which can assist in funding
operations while we continue to develop our drug delivery technologies. It will
also provide operational synergies as two business operations are combined in
one infrastructure creating efficiencies in administrative functions as well as
other areas (see Note 12). There can be no assurance this transaction
will be completed or that we will be able to execute the business
plan.
|
2.
|
Significant
Accounting Policies
|
Accounting
policies
There
have been no significant changes in the Company’s accounting policies (as
detailed in the Company's Annual Report on Form 10-K for the year ended December
31, 2009). The following significant accounting policies are included
herein.
Risk
and uncertainties
The
Company is embarking on a new business plan consistent with the impending
MediSync merger. The Company has no experience in consolidating
businesses or in the contract research organization space. The
Company may be unable to successfully combine the businesses or obtain the
necessary experience to compete effectively in the contract research
organization industry.
Debt
instruments, offering costs and the associated features and instruments
contained therein
Deferred
financing costs are amortized over the term of their associated debt
instruments. The Company evaluates the terms of the debt instruments to
determine if any embedded derivatives or beneficial conversion features exist.
The Company allocated the aggregate proceeds of the debt instrument between the
warrants and the debt based on their relative fair values as codified in ASC
470. The fair value of the warrants issued to debt holders or placement agents
are calculated utilizing the black scholes or probability weighted binomial
method depending on the terms of the warrant agreements. The Company amortizes
the resultant discount or other features over the terms of the debt through its
earliest maturity date using the effective interest method. Under this method,
the interest expense recognized each period will increase significantly as the
instrument approaches its maturity date. If the maturity of the debt is
accelerated because of defaults or conversions, then the amortization is
accelerated.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
Fair
Value Measurements
The
Company measures fair value in accordance with Statement ASC 820, Fair Value
Measurements (“ASC 820”). ASC 820 defines fair value, establishes a framework
and gives guidance regarding the methods used for measuring fair value, and
expands disclosures about fair value measurements. ASC 820 clarifies that fair
value is an exit price, representing the amount that would be received to sell
an asset or paid to transfer a liability in an orderly transaction between
market participants. As such, fair value is a market-based measurement that
should be determined based on assumptions that market participants would use in
pricing an asset or liability. As a basis for considering such assumptions,
there exists a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value as follows:
• Level 1
- - unadjusted quoted prices in active markets for identical assets or liabilities
that the Company has the ability to access as of the measurement
date.
• Level 2
- - inputs other than quoted prices included within Level 1 that are directly
observable for the asset or liability or indirectly observable through
corroboration with observable market data.
• Level 3
- - unobservable inputs for the asset or liability only used when there is little,
if any, market activity for the asset or liability at the measurement
date.
This
hierarchy requires the Company to use observable market data, when available,
and to minimize the use of unobservable inputs when determining fair
value
Derivative
Financial Instruments
Derivatives
are recognized at fair value as required by ASC 815 “Derivatives and Hedging”
(“ASC 815”). ASC 815 affects the accounting for warrants and many
convertible instruments with provisions that protect holders from a decline in
the stock price (or “down-round” provisions). For example, warrants with such
provisions will no longer be recorded in equity. Down-round provisions reduce
the exercise price of a warrant or convertible instrument if a company either
issues equity shares for a price that is lower than the exercise price of those
instruments or issues new warrants or convertible instruments that have a lower
exercise price. The Company evaluated whether its warrants contain provisions
that protect holders from declines in its stock price or otherwise could result
in modification of either the exercise price or the shares to be issued under
the respective warrant agreements. The Company determined that a
portion of its outstanding warrants contained such provisions thereby concluding
they were not indexed to the Company’s own stock.
At
September 30, 2010, the Company has recorded the fair value (Level 3) of the
derivative liabilities of $10.2 million, which consists of two
components:
• the
fair value of the warrant liability amounted to $5.5 million based on a binomial
pricing model of weighted average probabilities of potential down-round
scenarios for our securities using similar assumptions as noted in Note 10 of
the Company’s condensed consolidated financial statements for the period ended
September 30, 2010 for the valuation of stock options, except that the value of
the underlying common stock has been reduced by 10% to reflect a “lack of
marketability” discount arising since the underlying shares issuable upon
exercise of the warrant are restricted from resale under Section 5 of the
Securities Act of 1933 and subject to legend removal under Rule 144;
and
• the
fair value of the convertible debt conversion feature amounted to $4.7 million
utilizing a level 3 market value based on pricing methodologies used to
determine conversion features, which includes determining the fair value of the
Company’s stock as of September 30, 2010. Since the shares underlying
the convertible debt may be subject to legend removal under Rule 144 by “tacking
back” to the date of the original note issuance, it is not appropriate to apply
a “lack of marketability” discount to the quoted stock price at the end of the
measurement period.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
As a
result of the change in the fair value of derivative instruments, the Company
recognized a $0.6 million and $5.3 million loss on derivative financial
instruments for the three and nine month periods ended September 30, 2010,
respectively, on the condensed consolidated statement of
operations.
Recently
issued accounting standards
In
January 2010, the Financial Accounting Standards Board (“FASB”) issued guidance
to amend the disclosure requirements related to recurring and nonrecurring fair
value measurements. The guidance requires new disclosures on the transfers
of assets and liabilities between Level 1 (quoted prices in active market for
identical assets or liabilities) and Level 2 (significant other observable
inputs) of the fair value measurement hierarchy, including the reasons and the
timing of the transfers. Additionally, the guidance requires a roll forward
of activities on purchases, sales, issuance, and settlements of the assets and
liabilities measured using significant unobservable inputs (Level 3 fair value
measurements). The guidance became effective for us with the reporting period
beginning January 1, 2010, except for the disclosure on the roll forward
activities for Level 3 fair value measurements, which will become effective for
us with the reporting period beginning July 1, 2011. Other than requiring
additional disclosures, adoption of this new guidance did not have a material
impact on the Company’s condensed consolidated financial
statements.
|
3.
|
Property and Equipment,
Net
|
Property
and equipment, net consist of the following:
|
|
|
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 |
|
Depreciation
and amortization expense, included in cost and expenses in the accompanying
condensed consolidated statements of operations, was approximately $0.03 million
and $0.04 million for the three months ended September 30, 2010 and 2009,
respectively, and $0.08 million and $0.16
million for the nine months ended September 30, 2010 and 2009,
respectively.
4. Accrued
Expenses and Other
Accrued
expenses and other consist of the following:
|
|
|
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).
|
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
|
5.
|
Promissory
Note Due to a Related Party
|
In
December 2009, the Company issued to STSG a promissory note (“2009 Promissory
Note”) with a principal amount of $2.0 million, with interest accruing at the
rate of 6% per year and a maturity date of February 2,
2013. 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 prospective equity
or debt financing within certain parameters set forth (“Qualified
Financing”).
On
December 28, 2009, the Company paid STSG $0.3 million to reduce the principal
amount of the 2009 Promissory Note to $1.8 million as of December 31, 2009 and
September 30, 2010. A prepayment in the amount of $0.5 million is due from the
Company upon receipt of gross proceeds of each of $3.5 million and $4.0 million
from a Qualified Financing. The balance of the principal amount of the 2009
Promissory Note and all accrued and unpaid interest thereon is to be repaid upon
consummation of a Qualified Financing with gross proceeds (in the aggregate) of
more than $6.0 million. The Company closed on approximately $2.9 million of
Qualified Financings as of September 30, 2010, as described in Note 6 and Note
7.
|
6.
|
Senior
Subordinated Convertible Promissory Notes, Net of
Discount
|
In
February 2010 and May 2010, the Company sold to accredited investors
(“Investors”) in a private placement $1.1 million and $0.7 million,
respectively, principal amount of Senior Subordinated Convertible Promissory
Notes due 2013 (the “2010 Notes”). The 2010 Notes bear no interest
and are convertible into the Company’s common stock at the option of the
Investors anytime at an initial conversion price of $0.20 per
share. The conversion price automatically reduces by 1.5% of the
conversion price after each 90 day period that 2010 Notes are outstanding, and
additionally, the conversion price resets in the event of a subsequent issuance
of stock at a lower price than the then effective conversion price. In addition,
the 2010 Notes automatically convert into the Company’s common stock if the
closing bid price of the Company’s common stock equals or exceeds 300% of the
conversion price for a period of twenty consecutive trading
days.
In
connection with the sale of the 2010 Notes, the Company also issued to the
Investors five-year warrants to purchase an aggregate of 5,300,000 shares with
an exercise price of $0.20 per share and 3,625,000 shares of the Company’s
common stock with an exercise price of $0.25 per share,
respectively. The warrants contain a cashless exercise provision and
“full ratchet” anti-dilution provisions. In conjunction therewith, the
Company provided customary “piggyback” registration rights for a 24-month period
to the Investors with respect to the shares of common stock underlying the 2010
Notes and related warrants.
Upon
consummation of the sale of the 2010 Notes, the Company determined the relative
fair value of the aforementioned instruments and recorded debt discount on the
2010 Notes totaling $1.8 million (representing the derivative liabilities of
$0.5 million for the convertible debt conversion feature and $1.3 million for
the warrants limited to the amount of the proceeds), in accordance with
accounting for convertible instruments issued with detachable warrants (ASC
470). The Company recorded amortization debt discount of $14,844 and $26,858
for three and nine month periods ended September 30, 2010, respectively,
using the effective interest method as interest expense on the condensed
consolidated statement of operations. Unamortized debt discount at
September 30, 2010 totaled approximately $1.8 million.
The
Company received net proceeds of $0.8 million and $0.6 million from the 2010
Notes sold in February 2010 and May 2010, respectively, after payment of
commissions and expense allowance to Spencer Trask Ventures, Inc. (“STVI”) a
related party to STSG, a principal stockholder of the Company, to other finders
and other offering related costs. STVI and other finders also
received in the aggregate warrants to purchase 3,570,000 shares of the Company’s
common stock bearing substantially the same terms as the Investor
warrants. The Company incurred total debt issuance costs of $2.1 million,
representing the fair value of warrants issued to finders of $1.8 million and
other costs totaling $0.3 million. Such costs have been classified as other
assets in accordance with accounting for debt issue costs (ASC 835) and are
being amortized over the life of the corresponding debt using the effective
interest method. As of the three and nine month periods
ended September 30, 2010, amortization of such costs amounted to $15,734 and
$28,415, respectively, as a charge to interest expense on the condensed
consolidated statement of operations.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
At
September 30, 2010, the Company remeasured the fair value of these derivative
liabilities and determined the fair value of the warrant liability amounted to
$3.4 million and the fair value of the convertible debt conversion feature
amounted to $4.7 million. As a result of this remeasurement, the Company
recognized a $0.5 million and $6.4 million loss on these derivative financial
instruments for the three and nine month periods ended September 30, 2010,
respectively on the condensed consolidated statement of
operations. See Note 2 for description of the Company’s accounting
policies on valuing such instruments.
For the
three months ended September 30, 2010, the loss on derivatives consists of a
($0.4) million charge for the convertible debt conversion feature and a ($0.1)
million charge for the revaluation of the warrant liability on the condensed
consolidated statement of operations. The Company recorded a charge of
approximately $0.4 million for changes in the value of derivative instruments,
which included the above mentioned ($0.5) million charge, offset by favorable
changes in the valuation of other outstanding warrants of approximately $0.1
million.
For the
nine months ended September 30, 2010 the loss on derivatives consists of a
($4.2) million charge for the convertible debt conversion feature and a ($2.2)
million charge for the revaluation of the warrant liability on the condensed
consolidated statement of operations. The Company recorded a charge
of approximately $4.2 million for changes in the value of derivative
instruments, which included the above mentioned $(6.4) million charge, offset by
favorable changes in the valuation of other outstanding warrants of $2.2
million.
7. June
2010 Subordinated Convertible Promissory Notes
On June
30, 2010, the Company consummated a private placement to accredited investors
(“June Investors”) of $1.2 million principal amount of Subordinated Convertible
Promissory Notes due September 30, 2010 (the “June 2010 Notes”). The
sale of the June 2010 Notes also included issuance to June Investors of
five-year warrants to purchase an aggregate of 2,300,000 shares of the Company’s
common stock with an exercise price of $0.25 per share. The warrants
contain a cashless exercise provision and “full ratchet” anti-dilution
provisions. STVI acted as finder in connection with the private placement.
The June 2010 Notes bore interest at the rate of 6% per annum. In
connection with the final closing, the Company received net proceeds of $1.2
million as the payment of cash finder fees have been deferred until the next
offering.
In
accordance with accounting for convertible instruments issued with detachable
warrants (ASC 470), the Company determined the relative fair value of the
warrants at the time of closing at June 30, 2010 approximated $0.8 million,
resulting in the recognition of a derivative warrant liability and a
corresponding debt discount.
As of the
June 30, 2010 closing date, the Company incurred debt issuance costs with STVI,
in its capacity as a finder for the transaction, in the amount of $0.3
million. Such costs represent the fair value of the 460,000 warrants
issued to finders of $0.2 million and accrued finders fees of approximately $0.1
million, representing cash commission of up to 10% and a 3% expense allowance
and warrants.
At
September 30, 2010, the Company determined that the fair value of the derivative
liability immediately before conversion (see below) approximated $0.9 million
(see Note 2 for description of the Company’s accounting policies on valuing such
instruments). As a result, the Company recognized a loss on derivative
financial instruments for the three and nine months ended September 30, 2010 of
approximately $0.03 million and $0.4 million, respectively, on the condensed
consolidated statement of operations.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
On
September 30, 2010, the June Investors elected to convert the principal amount
of the June 2010 Notes and $17,392 of accrued interest into the Company’s common
stock. For each $0.20 of principal and interest converted, the June Investors
received both a share of the Company’s common stock and a 5 year warrant with an
expiration date in 2015 to purchase one share of common stock at an exercise
price of $0.25 per share. Therefore, the Company issued to June Investors upon
conversion of the June 2010 Notes 5,836,250 shares of its common stock and
5,836,250 warrants to purchase common stock. This private placement to
accredited investors is exempt from registration under the Securities Act of
1933, as amended, pursuant to Section 4(2) thereof and Regulation D, promulgated
thereunder. Upon conversion of the June 2010 Notes, the Company
recorded in interest expense on the condensed consolidated statement of
operations $0.3 million of deferred offering costs. The fair value of the
5,836,250 warrants issued to June Investors and the warrants issued to STVI to
purchase 1,150,000 shares of the Company’s common stock of $2.8
million (using the weighted average probabilities of potential down-round
scenarios and other assumptions utilizing a unmodified binomial
model). The Company recognized the fair value of the additional
warrants as an inducement charge.
.
|
8.
|
Termination of the Ferring
Agreement
|
On
December 21, 2009, the Company received notice from Ferring of its termination
of the License and Development Agreement, dated September 27, 2004, by and
between the Company and Ferring (“Agreement”) under Section 9.04 of the
Agreement, effective January 21, 2010. Pursuant to the
Agreement, upon a termination by Ferring under Section 9.04 after December 31,
2004, the following disposition of intellectual property associated with the
Agreement shall occur under Section 9.05 of the 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).
|
In July
2010, the Company filed a complaint against Ferring entitled “Vyteris, Inc. v.
Ferring Pharmaceuticals, Inc.” (the “Lawsuit”) in the Superior Court of New
Jersey, Chancery Division – Essex County to resolve outstanding issues with
respect to this termination. Ferring filed a motion to compel
arbitration in the case which is scheduled for hearing on November 19,
2010. As of September 30, 2010 and December 31, 2009, the Company
recorded $1.4 million in accrued expenses and other in the condensed
consolidated balance sheet for the estimated amounts due to
Ferring.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
|
9.
|
Related Party
Transaction
|
In
addition to the Promissory Note Due to a Related Party described in Note 5 and
finder’s fees described in Note 6 and Note 7, the Company paid Russell Potts,
one of its directors, approximately $3,253 for the nine months ended September
30, 2010, for consulting services and out of pocket expenses incurred in
2009.
|
10.
|
Stock-Based
Compensation
|
2005
Stock Option Plans
In April
2005, the Board of Directors and stockholders of the Company approved the 2005
Stock Option Plan (the “2005 Stock Option Plan”). Under the 2005 Stock Option
Plan, incentive stock options and non-qualified stock options to purchase shares
of the Company’s common stock may be granted to directors, officers, employees
and consultants Effective as of March 31, 2010, the Company amended its 2005
Stock Option Plan to increase the number of options available for grant under
the plan pursuant to authorization provided by the unanimous consent of its
Board of Directors. Specifically, the number of options available in
its 2005 Stock Option Plan was increased to 20,000,000 options available to
grant.
Options
granted under the 2005 Stock Option Plan vest as determined by the Compensation
Committee of the Board of Directors (the “Compensation Committee”) and terminate
after the earliest of the following events: expiration of the option as provided
in the option agreement, termination of the employee, or ten years from the date
of grant (five years from the date of grant for incentive options granted to an
employee who owns more than 10% of the total combined voting power of all
classes of the Company stock at the date of grant). In some
instances, granted stock options are immediately exercisable into restricted
shares of common stock, which vest in accordance with the original terms of the
related options. If an optionee’s status as an employee or consultant changes
due to termination, the Company has the right, but not the obligation, to
purchase from the optionee all unvested shares at the original option exercise
price. The Company recognizes compensation expense ratably over the
requisite service period.
The
option price of each share of common stock shall be determined by the
Compensation Committee, provided that with respect to incentive stock options,
the option price per share shall in all cases be equal to or greater than 100%
of the fair value of a share of common stock on the date of the grant, except an
incentive option granted under the 2005 Stock Option Plan to a shareholder that
owns more than 10% of the total combined voting power of all classes of the
Company stock, shall have an exercise price of not less than 110% of the fair
value of a share of common stock on the date of grant. No participant may be
granted incentive stock options, which would result in shares with an aggregate
fair value of more than $100,000 first becoming exercisable in one calendar
year.
2010
Directors’ Incentive Plan
In March
2010, the Company’s Board of Directors unanimously approved the Company’s 2010
Outside Director Cash Compensation and Stock Incentive Plan (the “2010
Directors’ Incentive Plan”). The 2010 Directors’ Incentive Plan,
which replaces the 2007 Directors’ Incentive Plan, increases the number of
authorized options under the Directors’ Incentive Plan from 2,583,333 options to
10,000,000 options. As of September 30, 2010, the Company issued
1,265,374 options to purchase shares of the Company’s common stock under the
2010 Directors’ Incentive Plan.
Summary
stock option activity for all plans for the nine month period ended September
30, 2010 is as follows:
|
|
|
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 |
|
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
The
following table summarizes information about stock options outstanding and
exercisable under all plans at September 30, 2010:
| |
|
|
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 |
|
The
following table summarizes the Company’s unvested stock options under all plans
as of September 30, 2010 and 2009:
|
|
|
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 |
|
Stock
options available for grant under all stock option plans covered a total of
13,400,560 shares of common stock at September 30, 2010. Stock
options available for grant under the 2005 Stock Option Plan covered 8,095,809
shares of stock, and the 2010 Outside Director Stock Incentive Plans covered
5,304,751 shares of stock at September 30, 2010.
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
granted in three and nine month periods ended September 30, 2010 and 2009 is as
follows:
|
|
|
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 |
% |
(1) The
Company did not grant stock options in the three months ended September 30,
2010.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
The
Company’s computation of expected life is based on historical exercise and
forfeiture patterns. The interest rate for periods within the contractual life
of the award is based on the U.S. Treasury yield curve in effect at the time of
grant. The key factors in the Company’s determination of expected volatility are
historical and market-based implied volatility, comparable companies with longer
stock trading periods than the Company and industry benchmarks. The following
table sets forth the total stock-based compensation expense resulting from stock
options in the Company’s condensed consolidated statements of operations for the
three and nine month periods ended September 30, 2010 and 2009:
|
|
|
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 |
|
As of
September 30, 2010, $1.5 million of total unrecognized compensation cost related
to stock options is expected to be recognized over a weighted-average period of
0.97 years.
Senior
Executive Employment Agreements
On
November 21, 2008, the Company entered into an employment agreement with Dr.
Hartounian effective as of May 1, 2008, which was renewed and is
currently set to expire on November 30, 2011. Dr. Hartounian’s
base salary is $0.3 million per year and is eligible for a bonus of up to 40% of
his salary payable in cash. In connection with the extension of the
term of the employment agreement, Dr. Hartounian is to be granted up to
7,423,970 options to purchase Company common stock, with the initial 5,196,780
options having been granted and 2,227,190 options to be granted upon raising of
$7.0 million by the Company. All options granted shall vest as
follows: 35% immediately upon issuance and 65% quarterly over three
years from date of grant.
On
November 21, 2008, the Company entered into an employment agreement with Joseph
N. Himy effective as of May 1, 2008, which was renewed and is currently set to
expire on November 30, 2011. Mr. Himy’s base salary is $0.2
million per year and he is eligible for a bonus of up to 25% of his salary
payable in cash or stock. Mr. Himy is to be granted up to 2,227,191
options, with the initial 1,559,034 options having been granted and 668,157
options to be granted upon raising of $7.0 million by the
Company. All options granted shall vest as follows: 35%
immediately upon issuance and 65% quarterly over three years from date of
grant.
Convertible
Note
On
September 30, 2009, the Company entered into a Settlement and Release Agreement
with 17-01 Pollitt Drive, L.L.C. (“Landlord”) with respect to its lease. Under
the settlement agreement the Company is to pay Landlord $0.5 million, which is
evidenced by the issuance of a five year interest only balloon note with
interest accruing at the rate of 6% per year. Upon a default by the Company
under this promissory note, the principal amount is increased to $0.6 million.
The note is convertible at the Landlord’s sole discretion into unregistered
common stock of the Company at the conversion price of $1.50 per
share. In exchange for the note, Landlord released the Company from
its obligations under the Company’s lease between Landlord and the
Company. This resulted in a gain on the settlement of this obligation
of $2.0 million.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
On September 12, 2010, the Company executed an Agreement and Plan
of Merger with MediSync MediSync, Company and the Merger Sub, pursuant to which
the Merger Sub will be merged with and into MediSync, with MediSync continuing
as the surviving corporation and a wholly-owned subsidiary of Company. MediSync is in the
business of consolidating preclinical and CRO and related businesses, including
SMOs, which sub-contract clinical trial-related responsibilities from a CRO or
pharmaceutical/biotechnology company, and post marketing surveillance companies,
which monitor pharmaceutical drugs and devices after release into the market.
MediSync believes that its future operations may provide added value to the
pharmaceutical and biotechnology industries as a valuable outsource service to
them. As a result of the Merger, the business of MediSync will be wholly
owned and operated by Company. The parties have made customary
representations, warranties, covenants and indemnification provisions in the
Merger Agreement. The parties’ obligations to consummate the closing of the
Merger are subject to certain closing conditions, including stockholder
approval, and there can be no assurance that the Merger will be
consummated. In addition, the Merger Agreement contains certain
termination rights for both parties. The Company had previously
anticipated that closing of the Merger would occur on or before November 15,
2010 if all closing conditions of both Company and MediSync were met. The
closing has been extended by the parties to December 15, 2010.
The
following is a summary of certain terms and conditions set forth in the Merger
Agreement.
Purchase
Price
The
Company has agreed to pay the following consideration to the holders of debt and
equity securities of MediSync in connection with the Merger:
|
|
·
|
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.
|
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
Subject
to the terms and conditions set forth in the Merger Agreement, the parties
agreed that upon consummation of the Merger, two current MediSync directors
shall be appointed to the Company’s Board of Directors.
As of the
date of this filing, we have received the requisite vote necessary to consummate
the merger, and the merger will close upon completion of the necessary steps
under Regulation 14C and filing of the certificates of merger in the State of
Delaware.
VYTERIS,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS-CONTINUED
(UNAUDITED)
|
13.
|
Loss Per Share and Warrant
Information
|
The
following table sets forth the computation of basic and diluted net loss
attributable to common stockholders per share for the three and nine month
periods ended September 30, 2010 and 2009.
|
|
|
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 |
) |
The
following table shows dilutive common share equivalents outstanding, which are
not included in the above historical calculations, as the effect of their
inclusion is anti-dilutive during each period.
|
|
|
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
The
following table summarizes information about warrants outstanding of which
27,615,469 are classified as derivative liabilities and exercisable at September
30, 2010:
| |
|
|
|
|
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 |
|
The
following table summarizes the major 2010 warrant issuances as
follows:
|
|
|
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 |
|
ITEM 2.
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
The following discussion and
analysis should be read in conjunction with the other financial information and
condensed consolidated financial statements and related notes appearing elsewhere in
this Quarterly Report on Form 10-Q. This discussion contains
forward-looking statements that involve risks and
uncertainties. Our actual results could differ materially from those
anticipated in the forward-looking statements as a result of a variety of factors,
including those discussed in “Risk Factors” and elsewhere in this Quarterly Report
on Form 10-Q.
Overview
Introduction
Vyteris,
Inc. (the terms “Vyteris”, “we”, “our”, “us” and the “Company” refer to each of
Vyteris, Inc. incorporated in the State of Nevada, its subsidiary, Vyteris, Inc.
(incorporated in the State of Delaware) and the consolidated company) has
developed and produced the first FDA-approved electronically controlled
transdermal drug delivery system that transports drugs through the skin
comfortably, without needles. This platform technology can be used to administer
a wide variety of therapeutics either directly into the skin or into the
bloodstream. We hold approximately 50 U.S. and 70 foreign patents relating to
the delivery of drugs across the skin using an electronically controlled “smart
patch” device with electric current.
Market
Opportunity
We
believe there are a significant number of pharmaceutical drugs with substantial
annual sales for which the patents are due to expire by 2012. Based on our
analysis, there are currently a significant number of these and other
FDA-approved drugs that may be relatively easily formulated for transdermal
delivery and thus made eligible for new patent protection. We believe that the
application of our novel drug delivery technologies to such existing
therapeutics is an attractive means of prolonging the commercial viability of
many currently marketed drugs.
Merger
Agreement
In
September 2010 our Board of Directors has approved an Agreement and Plan of
Merger (the “Merger Agreement”) by and among MediSync BioServices, Inc., a
Delaware corporation (“MediSync”), Vyteris and a newly created subsidiary of the
Company (“Merger Sub“), pursuant to which the Merger Sub will be merged with and
into MediSync, with MediSync continuing as the surviving corporation and a
wholly-owned subsidiary of Vyteris (the “Merger”). As of early November 2010, we
have received requisite shareholder approval to consummate the Merger, and the
Merger will close upon completion of the 14C process and filing of the
certificates of merger in the State of Delaware. The proposed Merger
would substantially change the way we do business. MediSync is in the
business of consolidating preclinical and contract research organizations
(“CROs”) and related businesses, including site management organizations
(“SMOs”), which sub-contract clinical trial-related responsibilities from a CRO
or pharmaceutical/biotechnology company, and post marketing surveillance
companies, which monitor pharmaceutical drugs and devices after release into the
market. MediSync believes that its future operations may provide added value to
the pharmaceutical and biotechnology industries as a valuable outsource service
to them. The CRO business model is expected to provide cash flow
which can assist in funding operations while we continue to develop our drug
delivery technologies. It will also provide operational synergies as two
business operations are combined in one infrastructure creating efficiencies in
administrative functions as well as other areas.
Liquidity
On
September 30, 2010, our cash position was $1.2 million, and we had a working
capital deficit of $14.8 million. There is substantial doubt about our ability
to continue as a going concern. We implemented several cost reduction measures
in 2009 and 2010, including headcount and salary reductions, reducing the level
of effort spent on research and development programs, general decrease in
overhead costs and renegotiation of our cost structures with our vendors. In
December 2009, Ferring discontinued its collaborative effort with us for our
joint infertility project, which had been our principal source of cash flow,
other than proceeds from our December 2009 sale of State of New Jersey tax
credits. Thus, unless we are able to raise additional funding, we may
be unable to continue operations. Especially in the current economic
climate and given that 75.6% of our common stock is controlled by a single
entity, additional funding may not be available on favorable terms or at all.
Failure to obtain such financing would require management to substantially
curtail operations, which would result in a material adverse effect on our
financial position and results of operations. In the event that we do raise
additional capital through a borrowing, the covenants associated with existing
debt instruments may impose substantial impediments on us.
Technology
Overview
of Electrotransport, or Active Transdermal Drug Delivery
Our
active transdermal drug delivery technology (also referred to as our smart patch
technology) is based on a process known as electrotransport, or more
specifically, iontophoresis, a process that transports drugs through the skin by
applying a low-level electrical current. Our patented technology works by
applying a charge to the drug-holding reservoir of the patch. A positive charge
is applied to a reservoir where a positively charged drug molecule is
held. Because like-charges repel, the drug molecules are forced out
of the reservoir and into the skin (the same process can occur when a negative
charge is applied to a reservoir containing a negatively charged drug
molecule).
Our
Approach to Iontophoresis
We have
developed a proprietary technology encompassing a series of significant
improvements to drug formulation and commercial manufacturing. We
used this technology with our FDA-approved product, LidoSite, and are currently
in various stages of testing this technology to deliver peptides and small
molecules. Many of our innovations center on the way we approach designing and
formulating electronically controlled drug delivery patches. Our
patches are pre-filled with the proper dosage of drug during the manufacturing
process. They are designed to be disposable after a single
application and are discreet in appearance. Further, we designed our
patches so that they can be quickly and cost-effectively mass-produced using
automated manufacturing processes.
To
complement our patch design, we approached the design of electronic controllers
with the goal of being small, wearable, simple to operate and programmable to
handle simple, as well as complex, drug delivery profiles. The dose
controller contains a miniature battery and circuitry controlling delivery rate,
and is capable of recording information on the amount and time of drug
delivered. We believe the controllability and programmability offered by our
technology are distinct competitive advantages that will enable our products to
deliver more consistent and predictable results for a broad range of existing
and new drugs.
Business
Model
Our long
term viability with respect to our drug delivery business is linked to our
ability to successfully pursue new opportunities with products that can be
delivered by means of our smart patch technology, such as those facing patent
expiration. In addition to extended patent and clinical usage, our platform may
also be a useful tool for pharmaceutical and biotechnology companies to reduce
their research and development investment and protect their brands against
generics. Based upon these tenets, our business model for achieving
corporate growth focuses on three areas: commercialization and
revenue-development strategies, technology initiatives and acquisition
opportunities. We intend to carry on with our active transdermal drug delivery
technology in its current form of operation after the Merger is
consummated.
Our
commercialization strategy is to develop near-term and future market
opportunities utilizing FDA-approved and marketed drugs (primarily peptides and
small molecule drugs) with our proprietary delivery technology. By targeting
compounds that may qualify for accelerated development and regulatory pathways
such as those implemented under Section 505(b)(2) of the Federal Food, Drug and
Cosmetic Act, we strive to develop and commercialize products that can reach the
market faster and at a reduced cost as compared to the traditional development
and regulatory approval processes for new drugs. We are in the process of
undertaking two feasibility studies, with the goal of converting at least one of
those studies into a full development program in 2010. Additionally,
we are exploring various strategies to derive revenue from our FDA approved
LidoSite product, and our phase II infertility (upon completion of a settlement
with Ferring Pharmaceuticals, Inc. (“Ferring”) arising out of the December 2009
termination of the joint infertility project by Ferring) and phase I migraine
projects. These strategies include sale or licensing of these products to third
parties and pursuit of partnership opportunities with other companies in the
pharmaceutical and biotechnology industries.
Technology
initiatives are also under way to expand our drug delivery capabilities so that
we are able to utilize our technology for a wider variety of pharmaceutical
applications. We are looking to improve our existing patch and
controller technology, as well as to implement innovative product
manufacturing methods to reduce materials costs. We also seek to combine our
technology with complementary technologies such as ultrasound and chemical
enhancers, in order to further increase transdermal drug penetration that may
lead to successful delivery of higher molecular weight drugs. As we move
toward commercially viable products, we continue to develop a comprehensive
strategy for efficient clinical and large scale manufacturing at lower cost of
goods, which may include outsourcing, to be presented to prospective development
partners.
We are
also looking for growth opportunities through the acquisition of late
development-stage or revenue-generating complementary businesses. We believe
that there may be small private drug development and related companies that
would have an interest in the benefits of becoming part of a public company,
including access to the capital markets as a public company and stockholder
liquidity.
We have
identified key areas of market opportunity in the areas of therapeutic peptides
and small molecules which we intend to pursue:
|
|
·
|
Women’s
health, such as infertility,
|
|
|
·
|
Metabolic
diseases, such as diabetes and
osteoporosis.
|
Our focus
on these core market areas represents our belief in their relatively near-term
commercialization and revenue-generating potential.
Female
Infertility Treatment
One of
our development opportunities is in the peptide delivery market. Pursuant to the
termination provisions of our former Development Agreement with Ferring, we
believe we now own the rights for the development of an innovative product to
treat female infertility using our smart patch technology and are negotiating
with Ferring with regard to our ability to utilize the technology, as part of a
settlement with Ferring. The product under development is designed to mimic the
female body’s natural rhythms of hormonal secretions, a characteristic important
in the delivery of therapeutics for the treatment of infertility. To be
effective, many patients currently need to undergo multiple injection-based
protocols for ovulation inducement, sometimes as many as eight daily injections
for up to three weeks. Our product would make it possible to administer the
peptide without needles in a painless, convenient and cost-effective manner.
There are also other potential benefits, including possible reduction of the
likelihood of multiple births.
Migraine
Treatment
Another
key area where we are seeking to apply our smart patch technology is the
treatment of migraines. Our active patch technology can be
pre-programmed for rapid delivery — as little as 15 minutes to achieve
therapeutic levels — followed by a sustained maintenance dose that may prevent
headache recurrence. If our smart patch is applied in this area, this
customizable drug delivery could offer advantages in the treatment of migraine,
and could improve patient satisfaction and patient compliance. We believe that
this could be a unique and significantly improved therapy and that it could be a
potentially effective way to significantly improve treating and preventing
recurring migraine headaches.
Pain
Management
Another
key area of potential partnership with pharmaceutical companies is in pain
management, specifically, the non-steroidal anti-inflammatory drug (“NSAID”)
sector, which falls in line with our strategy of pursuing high probability, low
risk opportunities leading to better patient care. Our active delivery system
bypasses the gastrointestinal tract, minimizing the GI side effects associated
with oral NSAIDs, and circumvents a major disadvantage of these commonly used
medications. We believe that if our smart patch technology is applied to NSAIDs,
the controlled drug delivery profile from our active patch could also curtail
overdosing of the drugs. This may represent a significant market opportunity if
we are successful in entering into a strategic partnership to penetrate the
NSAID market.
Metabolic
Diseases
We are
also exploring possible opportunities to use our technology to combat certain
metabolic diseases, including diabetes and osteoporosis.
Diabetes
Diabetes
mellitus is a common metabolic disease. It is characterized by a lack of insulin
secretion and/or increased cellular resistance to insulin, resulting in
hyperglycemia and other metabolic disturbances. People with diabetes suffer from
increased morbidity and premature mortality related to cardiovascular,
microvascular and neuropathic complications. The Diabetes Control and
Complication Trial has convincingly demonstrated the relationship of
hyperglycemia to the development and progression of complications and showed
that improved glycemic control reduced these complications. The delivery of
peptides (insulin or GLP-1) through the skin may be accomplished by
iontophoresis alone or by a combination of physical or chemical enhancement
technologies with iontophoresis for delivery of these therapies.
Osteoporosis
Osteoporosis
is a metabolic skeletal disorder wherein bone strength decreases and risk of
bone fracture increases. Bone strength is maintained by a continual process of
bone resorption and bone regeneration. Osteoporosis results when bone resorption
occurs at a faster rate than bone regeneration. We believe iontophoresis can be
used to transdermally deliver calcium-regulating hormones such as salmon
calcitonin and parathyroid hormone (1-34). Such delivery could be useful for
chronic treatment of post-menopausal osteoporosis and other clinical indications
as a superior alternative to injection.
Topical
Anesthesia
The first
area targeted with our smart patch technology, and our “proof of concept” case,
was primarily needle stick pain with a secondary focus on the areas of
dermatology, rheumatology and oncology procedures. On May 6, 2004, we received
approval from the FDA to commercially launch our first product,
LidoSite. LidoSite is a topical delivery system indicated for use on
normal intact skin to provide local anesthesia prior to needle stick procedures
such as venipunctures (blood draws), injections and intravenous therapies for
arthritis and oncology patients as well as superficial dermatological
procedures. Our LidoSite product, discontinued in 2008, used our
technology to achieve rapid, deep local anesthesia prior to these procedures. We
are currently seeking a sale, licensing or strategic partnering opportunity for
our LidoSite product line.
Significant
Accounting Policies
Our
discussion and analysis of our financial position and results of operations are
based upon our condensed consolidated financial statements, which have been
prepared in accordance with U.S. generally accepted accounting principles. Our
significant accounting policies are more fully described in our Annual Report on
Form 10-K for the year ended December 31, 2009. The preparation of
these condensed consolidated financial statements requires us to make estimates
and assumptions that affect the reported amounts of assets and liabilities, the
disclosure of contingent assets and liabilities at the date of the condensed
consolidated financial statements and the reported revenues and expenses during
the period.
We
consider certain accounting policies related to revenue recognition, accrued
expenses, stock-based compensation and deferred financing and other debt-related
costs to be significant to our business operations and the understanding of our
results of operations.
Revenue
Revenues
for the reimbursement of development costs when it bears all the risk for
selection of and payment to vendors and employees.
We use
revenue recognition criteria outlined in ASC 605. Accordingly,
revenues from licensing agreements are recognized based on the performance
requirements of the agreement. Non-refundable up-front fees, where we have an
ongoing involvement or performance obligation, are generally recorded as
deferred revenue in the balance sheet and amortized into license fees in the
statement of operations over the term of the performance obligation. Subsequent
milestone payments received are either recognized immediately or ratably, over a
development period, depending on the nature of the milestone collaborative
agreement terms and accounting guidance for collaborative
transactions.
Accrued
Expenses
As part
of the process of preparing our condensed consolidated financial statements, we
are required to estimate certain expenses. This process involves identifying
services that have been performed on our behalf and estimating the level of
service performed and the associated cost incurred for such service as of each
balance sheet date in our financial statements. Examples of estimated expenses
for which we accrue include professional service fees, contract service fees and
fees paid to contract research organizations in connection with the conducting
of clinical trials. Our estimates are most affected by our understanding of the
status and timing of services provided relative to the actual levels of services
incurred by such service providers. In the event that we do not identify certain
costs which have begun to be incurred or we under-estimate or over-estimate the
level of services performed or the costs of such services for a period, our
reported expenses for such period would be too low or too high. The date on
which certain services commence, the level of services performed on or before a
given date and the cost of such services are often estimated. We make these
estimates based upon the facts and circumstances known to us in accordance with
accounting principles generally accepted in the United States of
America.
Stock-based
Compensation
We
account for our stock based employee compensation plans under ASC 718 and ASC
505. ASC 718 and ASC 505 address the accounting for share based payment
transactions in which an enterprise receives employee services for equity
instruments of the enterprise or liabilities that are based on the fair value of
the enterprise's equity instruments or that may be settled by the issuance of
such equity instruments. ASC 718 and ASC 505 require that such
transactions be accounted for using a fair value based method.
In
considering the fair value of the underlying stock when we grant options or
restricted stock, we consider several factors, including third party valuations
and the fair values established by market transactions. Stock-based compensation
includes estimates of when stock options might be exercised, forfeiture rates
and stock price volatility. The timing for exercise of options is out of our
control and will depend, among other things, upon a variety of factors,
including our market value and the financial objectives of the holders of the
options. We have limited historical data to determine volatility in accordance
with Black-Scholes-Merton modeling or other acceptable valuation models under
ASC 718 and ASC 505. In addition, future volatility is inherently uncertain and
the valuation models have its limitations. These estimates can have a material
impact on stock-based compensation expense in our consolidated statements of
operations but will have no impact on our cash flows. Therefore determining the
fair value of our common stock involves significant estimates and
judgments.
Deferred
Financing and Other Debt-Related Costs
Deferred
financing costs are amortized over the term of its associated debt
instrument. We evaluate the terms of the debt instruments to
determine if any embedded derivatives or beneficial conversion features
exist. We allocate the aggregate proceeds of the notes payable
between the warrants and the notes based on their relative fair values in
accordance with ASC 470. The fair value of the warrants issued to
note holders or placement agents are calculated utilizing
the weighted average probability option-pricing model or probability
weighted outcomes using a binomial model, depending on the terms of the
instruments. We amortize the resultant discount or other features
over the terms of the notes through its earliest maturity date using the
effective interest method. Under this method, interest expense recognized each
period will increase significantly as the instrument approaches its maturity
date. If the maturity of the debt is accelerated because of defaults
or conversions, then the amortization is accelerated.
Fair
Value of Liabilities for Warrant and Embedded Conversion Option Derivative
Instruments
Under
applicable accounting guidance, an evaluation of outstanding warrants is made to
determine whether warrants issued are required to be classified as either equity
or a liability. Because certain warrants we have issued in connection with past
financings contain certain provisions that may result in an adjustment to their
exercise price, we classify them as derivative liabilities, and accordingly, we
are then required to estimate the fair value of such warrants, at the end of
each quarter. We use the weighted average probabilities of potential down-round
scenarios and other assumptions utilizing a unmodified binomial model to
estimate such fair value, which requires the use of numerous assumptions,
including, among others, expected life, volatility of the underlying equity
security, fair value of the underlying common stock, expectations of pricing of
the future financing rounds, a risk-free interest rate and expected dividends.
The use of different values by management in connection with these assumptions
in the weighted average probabilities of potential down-round scenarios and
other assumptions utilizing a unmodified binomial model could produce
substantially different results. Because we record changes in the fair value of
warrants classified as derivative liabilities as either a charge or credit in
our condensed consolidated statement of operations, materially different results
could have a material effect on our results of operations.
Recently
Issued Accounting Standards
In
January 2010, the FASB issued guidance to amend the disclosure requirements
related to recurring and nonrecurring fair value measurements. The guidance
requires new disclosures on the transfers of assets and liabilities between
Level 1 (quoted prices in active market for identical assets or liabilities) and
Level 2 (significant other observable inputs) of the fair value measurement
hierarchy, including the reasons and the timing of the
transfers. Additionally, the guidance requires a roll forward of activities
on purchases, sales, issuance, and settlements of the assets and liabilities
measured using significant unobservable inputs (Level 3 fair value
measurements). The guidance became effective for us with the reporting period
beginning January 1, 2010, except for the disclosure on the roll forward
activities for Level 3 fair value measurements, which will become effective for
us with the reporting period beginning July 1, 2011. Other than requiring
additional disclosures, adoption of this new guidance did not have a material
impact our condensed consolidated financial statements.
Consolidated
Results of Operations
The
following table sets forth the percentage increases or (decreases) in certain
line items on our condensed consolidated statements of operations for the three
and nine months ended September 30, 2010 as compared to the three and nine
months ended September 30, 2009:
|
|
|
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 |
% |
Comparison
of the Three Month Periods Ended September 30, 2010 and 2009
Revenues
Revenues
were $3,956 for the three months ended September 30, 2010, compared to $0.7
million for the comparable period in 2009, a decrease of 99.4% or $0.7 million.
Our revenue for the three-month period ended September 30, 2009 was primarily
derived from reimbursement of product development costs from Ferring. This
decrease is primarily attributable to the termination by Ferring of its License
Agreement with us in December 2009.
Research
and development
Research
and development expenses was $0.6 million for the three months ended September
30, 2010 and 2009. In 2009 our primary research and development project was our
infertility project with Ferring. However, in 2010, due to the termination of
the Ferring project, we have instead allocated our research and development
resources to internal development projects in the areas of therapeutic peptides
and small molecules which we intend to pursue, such as diabetes and
osteoporosis.
General
and administrative
General and administrative expenses totaled $1.0 million for the three months
ended September 30, 2010, as compared to $0.5 million for the comparable period
in 2009, an increase of 76.4%, or $0.4 million. General and administrative
expense for the three months ended September 30, 2010 included a non-cash charge
of $0.3 million for the fair value of employee and director share-based payments
as compared to approximately $0.2 million for the comparative period in the
prior year. The increase in general and administrative expenses is primarily
attributable to an increase in investor relations costs, legal fees, and
consulting arrangements.
Registration
rights penalty
The
registration rights penalty for failure to register common stock issued totaled
$0.1 million for the three months ended September 30, 2009. On October 30,
2009, we entered into an Amendment and Waiver (“Amendment”) to the Registration
Rights Agreement dated September 29, 2004 among the Company, Spencer Trask
Ventures, Inc., a related party, Rodman & Renshaw, LLC, and various
shareholders. The Amendment required us to compensate investors for registration
rights penalties incurred of approximately $2.6 million. We issued 1,250,000
restricted shares of our common stock with a fair value of $0.8 million and
warrants to purchase up to 1,250,000 restricted shares of our common stock at an
exercise price of $0.75 per share with an expiration date of October 30, 2012 in
order to settle the accrued liquidated damages. Accordingly we did not incur
registration right penalty expense in the three month period ended September 30,
2010.
Interest
(income) expense, net
Interest
(income) expense, net totaled $3.7 million for the three months ended September
30, 2010, as compared to $0.4 million for the comparable period in 2009, an
increase of $3.3 million or 806.1%. The increase in interest (income)
expense, net, for the three months ended September 30, 2010 is primarily
attributable to the non-cash warrant expense issued to investors of $0.5 million
and the non-cash interest expense charge of $2.8 million for the fair value of
5,836,250 warrants issued to noteholders to purchase our common stock at an
exercise price of $0.25 per share to induce conversion of the June 30, 2010
convertible notes into common stock.
Increase
in fair value of derivative financial instruments
We
performed an evaluation to determine whether our equity-linked financial
instruments (or embedded features) are indexed to our stock, including
evaluating the instruments contingent exercise and settlement provisions in
accordance with ASC Topic 815. This requirement affects the accounting for
our warrants that protect holders from a decline in the stock price (or
“down-round” provisions). This also affects the beneficial conversion feature of
the 2010 Notes, which have an initial conversion price of $0.20 per share (but
such price decreases by 1.5% each 90 period that the instrument is outstanding,
and contains a reset provision in the event subsequent equity raises are at a
lower value). For the three month period ended September 30, 2010, we recorded
an expense of $0.6 million in the condensed consolidated statement of operations
due to the changes in the fair value of our issued warrants that contain such
anti-dilution provisions and the variable beneficial conversion feature, using
the weighted average probabilities of potential down-round scenarios and other
assumptions utilizing a unmodified binomial model.
Comparison
of the Nine Month Periods Ended September 30, 2010 and 2009
Revenues
Revenues
were $0.1 million for the nine months ended September 30, 2010, compared to $2.1
million for the comparable period in 2009, a decrease of 93.4% or $2.0 million.
Our revenue for the nine-month period ended September 30, 2009 was primarily
derived from reimbursement of product development costs from Ferring. This
decrease is primarily attributable to the termination by Ferring of its License
Agreement with us in December 2009. Our revenue for the nine-month period ended
September 30, 2010 was primarily derived from research and development work
performed on behalf of our other customers.
Research and
development
Research
and development expenses were $2.1 million for the nine months ended September
30, 2010, compared to $2.2 million for the comparable period in 2009, a decrease
of 7.0% or $0.2 million. Research and development expenses for the nine months
ended September 30, 2010; include a non-cash charge of $0.4 million for the fair
value of employee share-based payments as compared to approximately $0.1 million
for the comparative period in the prior year. This decrease in research and
development expenses is primarily attributable to the termination by Ferring of
its License Agreement with us and the completion of the related phase II
clinical trial in December 2009. In 2010, we allocated our research and
development resources to internal development projects in the areas of
therapeutic peptides and small molecules which we intend to pursue, such as
diabetes and osteoporosis.
General
and administrative
General
and administrative expenses totaled $4.3 million for the nine months ended
September 30, 2010, as compared to $2.3 million for the comparable period in
2009, an increase of 86.1%, or $2.0 million. General and administrative expense
for the nine months ended September 30, 2010, included a non-cash charge of $1.6
million for the fair value of employee and director share-based payments as
compared to approximately $0.4 million for the comparative period in the prior
year. The increase in general and administrative expenses of $0.7 million, net
of the increase in non-cash charges, is primarily attributable to an increase in
investor relations costs, legal fees, and consulting arrangements.
Facilities
realignment and impairment of fixed assets
Expenses
for facilities realignment and impairment of fixed assets totaled $0.2 million
for the nine months ended September 30, 2009. On September 30, 2009, we entered
into a Settlement and Release Agreement with the landlord of this facility and
accordingly we did not incur facility realignment expense in the nine month
period ended September 30, 2010.
Registration
rights penalty
The
registration rights penalty for failure to register common stock issued totaled
$0.2 million for the nine months ended September 30, 2009. On October 30,
2009, we entered into an Amendment and Waiver (“Amendment”) to the Registration
Rights Agreement dated September 29, 2004 among the Company, Spencer Trask
Ventures, Inc., a related party, Rodman & Renshaw, LLC, and various
shareholders. The Amendment required us to compensate investors for registration
rights penalties incurred of approximately $2.6 million. We issued 1,250,000
restricted shares of our common stock with a fair value of $0.8 million and
warrants to purchase up to 1,250,000 restricted shares of our common stock at an
exercise price of $0.75 per share with an expiration date of October 30, 2012 in
order to settle the accrued liquidated damages. Accordingly we did not incur
registration right penalty expense in the nine month period ended September 30,
2010.
Interest
(income) expense, net
Interest
(income) expense, net totaled $3.8 million for the nine months ended September
30, 2010, as compared to $1.3 million for the comparable period in 2009, an
increase of $2.5 million or 202.0%. The increase in interest (income)
expense, net, for the nine months ended September 30, 2010 is primarily
attributable to the non-cash warrant expense issued to investors of $0.5 million
and non-cash interest expense charge of $2.8 million for the fair value of
5,836,250 warrants issued to noteholders to purchase our common stock at an
exercise price of $.0.25 per share to induce conversion of the June 30, 2010
convertible notes into common stock.
Increase
in fair value of derivative financial instruments
We
performed an evaluation to determine whether our equity-linked financial
instruments (or embedded features) are indexed to our stock, including
evaluating the instruments contingent exercise and settlement provisions in
accordance with ASC Topic 815. This requirement affects the
accounting for our warrants that protect holders from a decline in the stock
price (or “down-round” provisions). This also affects the beneficial conversion
feature of the 2010 Notes, which have an initial conversion price of $0.20 per
share (but such price decreases by 1.5% each 90 period that the instrument is
outstanding, and contains a reset provision in the event subsequent equity
raises are at a lower value). For the nine month period ended September 30,
2010, we recorded an expense of $5.3 million in the condensed consolidated
statement of operations due to the changes in the fair value of our issued
warrants that contain such anti-dilution provisions and the variable beneficial
conversion feature, using the weighted average probabilities of potential
down-round scenarios and other assumptions utilizing a unmodified binomial
model.
Gain
on settlement of lease obligations
On
September 30, 2009, we entered into a Settlement and Release Agreement with
17-01 Pollitt Drive, L.L.C. with respect to our former leasehold at
17-01 Pollitt Drive. The settlement called for us to pay the Landlord
$0.5 million, which is evidenced by the issuance of a five year
interest only balloon note with interest accruing at the rate of 6% per
year. In exchange the landlord released us from our obligations under
the lease resulting in a credit of $(2.0) million for the nine month period
ended September 30, 2009 in the condensed consolidated statement of
operations.
Liquidity
and Capital Resources
The
condensed consolidated financial statements have been prepared assuming that we
will continue as a going concern; however, we had cash and cash equivalents of
$1.2 million and a working capital deficit of $14.8 million, as of September 30,
2010, which are not sufficient to allow us to continue operations without
additional funding, especially given the fact that the Company has approximately
$2.0 million in accounts payable which are more than 60 days past due, with
increasing numbers of creditors either making claims and/or commencing
litigation against us. No assurance can be given that we will be successful in
arranging additional financing needed to continue the execution of our business
plan, which includes the development of new products. Failure to obtain such
financing may require management to substantially curtail operations, cease
operating our business or file for bankruptcy, which would result in a material
adverse effect on our financial position and results of operations. Since
February 2008, our primary source of financing has been loans, development fees
and milestone payments from our collaborative partner, Ferring. In December
2009, Ferring terminated its License Agreement with us and thus we are no longer
receiving any payments from Ferring. These factors raise substantial doubt about
our ability to continue as a going concern. The condensed consolidated financial
statements do not include any adjustments to reflect the possible future effects
on the recoverability and classification of assets or the amounts and
classification of liabilities that might occur if we are unable to continue in
business as a going concern.
In
November 2010, we were awarded two equal grants totaling $0.5 million under the
IRS Qualifying Therapeutic Discovery Project (QTDP) program. The grants will be
used to advance our smart patch technology for the delivery of therapeutic
medicines planned for use to treat female infertility and
diabetes. The QTDP program was created by the U.S. Congress as part
of the Patient Protection and Affordable Care Act passed on March 23,
2010. Eligibility for the grant requires that a project have the
potential to develop new treatments that address "unmet medical needs" or
chronic and acute diseases; reduce long-term health care costs; or represent a
significant advance in finding a cure for cancer.
Cash
flows from operating activities
For the
nine-month period ended September 30, 2010, net cash used in operating
activities was $3.5 million, as compared to $0.6 million of net cash used in
operating activities in the comparable period in the prior year. The increase in
net cash used in operating activities for the nine month period
ended September 30, 2010 as compared to same period in the prior year
is primarily due to Ferring’s termination of its License Agreement with us in
December 2009 and discontinuance of reimbursement of our product development
expenditures under the Agreement. We received $3.1 million of such
reimbursement of product development expenses in the nine month period ended
September 30, 2009. We redeployed the resources working in this project to other
projects, and therefore, our fixed costs have remained relatively constant.
Until our business development activities are successful, we shall continue to
utilize more cash in operating activities than is generated, and this trend may
increase in the future as we engage in increased business development
activities. Therefore, we will be dependent upon cash flows from financing
activities to fund our operations for the foreseeable future.
Cash
flows from investing activities
For the
nine-month period ended September 30, 2010, we did not incur any cash
expenditures in investing activities as we significantly reduced variable
spending as part of our cost reduction initiatives. For the
nine-month period ended September 30, 2009, net cash provided by investing
activities was $0.1 million.
Cash
flows from financing activities
For the
nine-month period ended September 30, 2010, net cash provided by financing
activities was $2.5 million, as compared to $0.6 million of net cash provided by
financing activities in the comparable period in the prior year. During the
nine-month period ended September 30, 2010, we sold to accredited investors
$1.8 million principal amount of senior subordinated convertible promissory
notes due 2013 and $1.1 million of subordinated convertible promissory
notes which was partially offset by $0.4 million in related debt issuance costs.
During the nine-month period ended September 30, 2009, we received gross
proceeds of $1.0 million from the sale of our PMK 150 Patch manufacturing
machine which was partially offset by the repayment of $0.4 million of senior
secured convertible debentures due to Ferring.
Financing
History 2009 and 2010
In March
2009, we entered into a transaction with Ferring whereby they agreed to fund the
first half of the 2009 development budget up to $3.3 million, in exchange for
which we granted Ferring a senior security interest in our assets (which Ferring
has agreed to subordinate to the security interest of new third party lenders
for a value of over $3.3 million).
Ferring
also agreed to buy our PMK 150 machine for $1.0 million, of which
$0.5 million was paid at closing (half to satisfy outstanding senior
secured convertible debentures due to Ferring) and $0.3 million was paid on May
14, 2009 (part to satisfy accrued and unpaid interest on loans from Ferring) and
which has been leased back to us at a rental amount of $1,000 per month. We
account for the lease of the PMK 150 machine as an operating lease and are
recognizing the deferred gain on the sale of the machine over the 10 year
lease.
Termination
of Ferring Agreement
On
December 21, 2009, we received notice from Ferring of its termination of the
License and Development Agreement, dated September 27, 2004, by and between
us and Ferring (“Agreement”) under Section 9.04 of the Agreement, effective
January 21, 2010. Pursuant to the Agreement, upon a termination
by Ferring after December 31, 2004, the following disposition of intellectual
property associated with the Agreement shall occur under Section 9.05 of the
Agreement:
|
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).
|
In July
2010, we filed a complaint against Ferring entitled “Vyteris, Inc. v. Ferring
Pharmaceuticals, Inc.” in the Superior Court of New Jersey, Chancery
Division – Essex County to resolve outstanding issues with respect to this
termination. There is no further disposition other than a hearing
scheduled for late November 2010.
Other
Financings
October
30, 2009 Private Placement
On
October 30, 2009, we issued 3,000,000 shares of our common stock and 3,000,000
warrants to purchase our common stock to an investor for a purchase price of
$0.6 million in a transaction exempt from registration under Section 4(2) of the
Securities Act of 1933. The warrants are exercisable into shares of our common
stock at an exercise price of $0.20 per share, and bear a term of five years
from the date of closing. The warrants contain a cashless exercise
provision and “full ratchet” anti-dilution provisions. We paid finders fees in
the amount of $0.1 million and issued a total of 1,200,000 warrants allocated as
follows: (i) 600,000 warrants representing 20% of the common stock issued to
investors and (ii) 600,000 warrants representing 20% of the warrants issued to
investors in connection with this private placement recorded as a reduction of
equity as a cost of the transaction. All warrants issued contain terms identical
to the terms of the warrants issued to the investors.
Proceeds
from previously approved sale of State of New Jersey net operating tax
losses
On
December 23, 2009, we consummated a non-dilutive capital raise in the net amount
of $2.1 million. The State of New Jersey approved the sale of our prior year’s
state net operating tax losses and research tax credits through the New Jersey
Economic Development Authority (NJEDA). The funding has been used for operations
and capital expenditures in accordance with rules, regulations and stipulations
set forth by the New Jersey program.
Senior
subordinated convertible promissory notes, net of discount
In
February 2010 and May 2010, we sold to accredited investors (“Investors”)
in a private placement $1.1 million and $0.7 million, respectively, principal
amount of Senior Subordinated Convertible Promissory Notes due 2013 (the “2010
Notes”). The 2010 Notes bear no interest and are convertible into our
common stock at the option of the Investors anytime at an initial conversion
price of $0.20 per share. The conversion price automatically reduces
by 1.5% of the conversion price after each 90 day period that 2010 Notes are
outstanding, and additionally, the conversion price resets in the event of a
subsequent issuance of stock at a lower price than the then effective conversion
price. In addition, the 2010 Notes automatically convert into our common stock
if the closing bid price of our common stock equals or exceeds 300% of the
conversion price for a period of twenty consecutive trading
days.
In
connection with the sale of the 2010 Notes, we also issued five-year warrants to
purchase an aggregate of 5,300,000 shares with an exercise price of $0.20 per
share and 3,625,000 shares of our common stock with an exercise price of $0.25
per share, respectively. In conjunction therewith, we provided
customary “piggyback” registration rights for a 24-month period to the Investors
with respect to the shares of common stock underlying the notes and
warrants.
Subordinated
convertible promissory notes, net of discount
On June
30, 2010, we consummated a private placement to accredited investors (“June
Investors”) of $1.2 million principal amount of Subordinated Convertible
Promissory Notes due September 30, 2010 (the “June 2010 Notes”). The sale
of the June 2010 Notes also included issuance to Investors of five-year warrants
to purchase an aggregate of 2,300,000 shares of our common stock with an
exercise price of $0.25 per share. As of September 30, 2010, the
Investors converted the June 2010 Notes into 5,836,250 shares of our common
stock and 5,836,250 warrants to purchase our common stock.
Cash
Position
See
“Liquidity and Capital Resources” under “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” for information on our cash
position.
Contractual
Obligations and Other Commitments
Our
contractual obligations and commitments include obligations associated with
capital and operating leases, manufacturing equipment, and employee agreements
as set forth in the table below:
|
|
|
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 |
|
(1) Debt
obligations are summarized as follows:
|
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 |
|
|
|
|
|
|
|
|
Forward-Looking
Information
This
Quarterly Report on Form 10-Q contains
forward-looking statements (within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended). When used in this Quarterly Report on Form 10-Q, the words
“anticipate,” “believe,” “estimate,” “will,” “plan,” “seeks,” “intend,” and
“expect” and similar expressions identify forward-looking statements. Although
we believe that our plans, intentions, and expectations reflected in any
forward-looking statements are reasonable, these plans, intentions, or
expectations may not be achieved. Our actual results, performance, or
achievements could differ materially from those contemplated, expressed, or
implied, by the forward-looking statements contained in this Quarterly Report
on Form 10-Q.
Important factors that could cause actual results to differ materially from our
forward-looking statements are set forth in this Quarterly Report on Form 10-Q, including
under the heading “Risk Factors.” All forward-looking statements attributable to
us or persons acting on our behalf are expressly qualified in their entirety by
the cautionary statements set forth in this Quarterly Report on Form 10-Q. Except as
required by federal securities laws, we are under no obligation to update any
forward-looking statement, whether as a result of new information, future
events, or otherwise.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our
exposure to market risk for changes in interest rates relates primarily to the
market-driven increase or decrease in interest rates, and the impact of those
changes on our ability to realize a return on invested or available funds. We
ensure the safety and preservation of our invested principal funds by limiting
default risk, market risk and reinvestment risk. We mitigate default risk by
investing in commercial checking and savings accounts.
ITEM
4. CONTROLS AND PROCEDURES
As of the
end of the period covered by this Quarterly Report on Form 10-Q, management
performed, with the participation of our Principal Executive Officer and
Principal Accounting Officer, an evaluation of the effectiveness of our
disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e)
of the Exchange Act. Our disclosure controls and procedures are designed to
ensure that information required to be disclosed in the report we file or submit
under the Exchange Act is recorded, processed, summarized, and reported within
the time periods specified in the SEC’s forms, and that such information is
accumulated and communicated to our management including our Principal Executive
Officer and our Principal Accounting Officer, to allow timely decisions
regarding required disclosures. Based on the evaluation above, our Principal
Executive Officer and our Principal Accounting Officer concluded that, as of
September 30, 2010, our disclosure controls and procedures were not
effective.
B. Changes
in Internal Control Over Financial Reporting
During
the quarter ended September 30, 2010, there have been no changes in our internal
controls or in other factors that could affect any corrective actions with
regard to deficiencies and material weaknesses with respect to internal controls
over financial reporting. As there has been no change in our internal
controls since disclosure in our Form 10-K for the year ending December 31,
2009, filed with the Securities and Exchange Commission, on March 25, 2010 with
regard to segregation of accounting duties, we reiterate the following material
weakness which also existed as of December 31, 2009.
Segregation of
Duties
We
currently have accounting staff limited to our chief financial officer and two
support staff members. Limited resources in this area may not provide
sufficient staffing for internal control purposes. This resulted in a
couple of proposed journal entries resulting from the audit process to correct
the recorded balances in our general ledger. In order to correct this
deficiency, we are in the process of augmenting our finance staff through the
prospective hire of additional accounting personnel as needed to ensure adequate
resources.
PART
II. OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
From time
to time, we are involved in lawsuits, claims, investigations and proceedings,
including pending opposition proceedings involving patents that arise in the
ordinary course of business. Except as set forth below, there are no matters
pending that we expect to have a material adverse impact on our business,
results of operations, financial condition or cash flows except for
approximately $0.7 million in accounts payable collection claims and
litigation. Unless we are able to obtain sufficient funds to commence
settlement of outstanding accounts payable, these numbers of claims and
litigation are likely to increase.
In July 2010, the Company
filed a complaint against Ferring entitled “Vyteris, Inc. v. Ferring
Pharmaceuticals, Inc.” (the “Lawsuit”) in the Superior Court of New Jersey,
Chancery Division – Essex County to resolve outstanding issues with respect to
this termination. Ferring filed a motion to compel arbitration in the
case which is scheduled for hearing on November 19, 2010. The Lawsuit is in its
initial stages, and we cannot predict the outcome of the Lawsuit, or what relief
we may receive, if we do prevail on the merits.
ITEM
1A. RISK FACTORS
You
should carefully consider the risks described below together with all of the
other information included in this report, as well as all other information
included in all other filings, incorporated herein by reference, when evaluating
the Company and its business. We only state those risk factors which may have
changed from our Form 10-K, filed for the year ended December 31,
2009. If any of the following risks actually occurs, our business,
financial condition, and results of operations could suffer. In that case, the
price of our common stock could decline and our stockholders may lose all or
part of their investment.
We
continue to experience a severe, continuing cash shortage and without sufficient
additional financing we may be required to cease operations, and this
demonstrates uncertainty as to our ability to continue as a going
concern.
As of
September 30, 2010, our cash and cash equivalents amounted to $1.2 million. In
2010, we have had minimal revenue, and we have been dependent upon proceeds from
financing activities to fund our operations. As of September 30,
2010, our current liabilities exceeded our current assets by approximately $14.8
million, and we have approximately $2.0 million in outstanding accounts payable
which are over 60 days past due. If we do not
continue to raise capital until we generate sufficient cash flow from operations
to cover this working capital deficit, we may be required to discontinue or
further substantially modify our business, in addition to the substantial cost
cutting measures that have been implemented in the last two years. We
cannot be certain that additional financing will be available to us on favorable
terms when required, if at all. The failure to raise needed funds could
have a material adverse effect on our business, financial condition, operating
results and prospects. Additionally, we face mounting claims and
litigation from our vendors and other parties to which we owe money, and we do
not have sufficient funds to pay such payables and/or to defend litigation which
may arise from nonpayment. These factors raise substantial doubt about our
ability to continue as a going concern. The report of the independent registered
public accounting firm relating to the audit of our consolidated financial
statements for the year ended December 31, 2009 contains an explanatory
paragraph expressing uncertainty regarding our ability to continue as a going
concern because of our operating losses and our need for additional capital.
Such explanatory paragraph could make it more difficult for us to raise
additional capital and may materially and adversely affect the terms of any
future financing that we may obtain.
Our
proposed merger with MediSync and entry into the Clinical Research Organization
(CRO) business may not be successful and may pose further risks to our
organization.
With the
impending merger with MediSync, we are embarking on an augmentation to our
business plan which involves shifting our focus solely from developing
transdermal drug delivery systems to complementing our business with the
business of running a CRO consolidation organization. The MediSync merger poses
the following material risks to us:
|
|
·
|
The
Company has no experience in consolidating businesses. The
consolidation will require both expertise and significant financial and
managerial resources. We will need to rely heavily on newly
retained personnel and outside resources to effectively
consolidate. There is no assurance that we will have the
financial resources to support use of the expertise or that we will
successfully combine the businesses with the assistance of our newly
marshaled resources.
|
|
|
·
|
We
have no expertise in the CRO space and will rely heavily on the limited
number of MediSync personnel to run the CRO business. There are
no assurances that the MediSync personnel have sufficient experience to
effectively run this business without expert guidance from our management
team.
|
|
|
·
|
We
have limited capital with which to run the MediSync
business. There is no assurance that we will be able to garner
the resources to compete effectively in the contract research organization
industry.
|
|
|
·
|
The
ability to effectively expand the CRO business is based largely upon our
“roll up” strategy. There is no assurance that we will be able
to obtain the capital necessary to consummate further CRO acquisitions or
to consolidate any of MediSync’s proposed acquisitions into the MediSync
subsidiary.
|
We
have never been profitable, we may never be profitable, and, if we become
profitable, we may be unable to sustain profitability.
From
November 2000 through September 30, 2010, we incurred net losses in excess of
$229.7 million, as we have been engaged primarily in clinical testing and
development activities. We have never been profitable, we may never be
profitable, and, if we become profitable, we may be unable to sustain
profitability. We expect to continue to incur significant losses for the
foreseeable future and will endeavor to finance our operations through sales of
securities and incurrence of indebtedness, of which there can be no
assurance.
Ferring’s
December 2009 termination of its License and Development Agreement with us and
the lawsuit we filed with respect to such termination could have a material
adverse effect on us.
Ferring’s
termination of its License and Development Agreement with us and the ensuing
lawsuit present several risks.
(i) Advances
and fundings made to us by Ferring pursuant to various Ferring agreements were
our principal source of revenues since 2006. Unless we are able to
secure another source of revenues, we will be dependent upon proceeds from
financings to fund our operations until alternative sources of revenue
develop.
(ii) Unless
we are able to secure an alternative development partner for our drug delivery
product for female infertility or are otherwise able to continue development of
this product on our own, we will in all likelihood have to abandon this product
line, which would likely have a material adverse effect on us both with respect
to our ability to derive a stream of revenues and our ability to bring a product
to market within the time frames previously anticipated by us.
(iii) In December 2009, Ferring terminated our September 27, 2004 agreement with
them pursuant to Section 9.04 thereof. As a result of the subsequent
inability to reach a reasonable resolution with Ferring, we filed a lawsuit
against Ferring on July 1, 2010 in the Superior Court of New Jersey, Chancery
Division – Essex County.
(iv)
Because of this lawsuit, we will be required to expend significant funds as well
as utilize significant amounts of time of our management and other
personnel. We cannot assure you that we will receive a favorable
outcome in the litigation, and in using our efforts and legal counsel to obtain
a favorable outcome, we cannot accurately predict the potential costs that will
be involved.
(v) In
connection with the March 2009 financing with Ferring, we granted Ferring a
first lien on all of our assets. If we are not able to reach a
favorable disposition in litigation, Ferring could exercise legal remedies
against us, including, but not limited to, foreclosing on our
assets.
Our
sale of a significant number of shares of our common stock, convertible
securities or warrants or the issuance or exercise of stock options or warrants
could depress the market price of our stock.
The
market price of our common stock could decline as a result of sales of
substantial amounts of our common stock in the public market or the perception
that substantial sales could occur because of our sale of common stock,
convertible securities or warrants, or the issuance or exercise of stock options
or warrants. These sales also might make it difficult for us to sell equity
securities in the future at a time when, and at a price which, we deem
appropriate.
As of
September 30, 2010, we had stock options to purchase 16,577,521 shares of our
common stock outstanding, of which options to purchase 8,129,735 shares were
exercisable. Also outstanding as of the same date were warrants exercisable
for 32,489,513 shares of our common stock and senior secured debentures
that can convert into 9,477,454 shares of our common stock. Exercise of any
current or future outstanding stock options or warrants could harm the market
price of our common stock.
We
are a controlled company and our majority shareholder may take actions adverse
to the interests of other shareholders.
As of
September 30, 2010, Spencer Trask Specialty Group, LLC or STSG, beneficially
owned approximately 75.6% of our issued and outstanding common stock. Due to
this stock ownership, we are controlled by STSG and deemed a “controlled
corporation”. This control occurred as a result of the December 22, 2009
restructuring and conversion into common stock of over $20.3 million of
preferred stock and senior secured debt that we owed to STSG. STSG
may take actions that conflict with the interests of other
shareholders. Due to STSG’s voting control of our common stock, STSG
has substantial control over us and has substantial power to elect directors and
to generally approve all actions requiring the approval of the holders of our
voting stock.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Conversion
of Notes Issued in June 2010 Financing
On June
30, 2010, we consummated a private placement to accredited investors (“ June
Investors”) of $1.2 million principal amount of 6% Subordinated Convertible
Promissory Notes due September 30, 2010 (the “June 2010 Notes”). The
sale of the June 2010 Notes also included issuance to the June Investors of
five-year warrants to purchase an aggregate of 2,300,000 shares of our common
stock with an exercise price of $0.25 per share. The warrants contain a
cashless exercise provision and “full ratchet” anti-dilution
provisions Spencer Trask Ventures, Inc. acted as finder in connection
with the private placement.
On
September 30, 2010, the June Investors elected to convert the principal amount
of the June 2010 Notes and $17,392 of accrued interest into our stock. For each
$0.20 of principal and interest converted, the June Investors received both a
share of our common stock and a 5 year warrant with an expiration date in 2015
to purchase one share of common stock at an exercise price of $0.25 per share.
Therefore, the Company issued to the June Investors upon conversion of the June
2010 Notes 5,836,250 shares of its common stock and 5,836,250 warrants to
purchase common stock. This private placement to accredited investors is
exempt from registration under the Securities Act of 1933, as amended, pursuant
to Section 4(2) thereof and Regulation D, promulgated thereunder.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
5. OTHER INFORMATION
None.
ITEM
6. EXHIBITS
|
Item 6(a)
|
Exhibits
|
|
|
|
|
31.1
|
Certification
by the Principal Executive Officer pursuant to Rule 13a-14(a) under the
Securities Exchange Act of 1934.
|
|
|
|
|
31.2
|
Certification
by the Principal Accounting Officer pursuant to Rule 13a-14(a) under the
Securities Exchange Act of 1934.
|
|
|
|
|
32.1
|
Certification
by the Principal Executive Officer pursuant to 18 U.S.C. Section
1350.
|
|
|
|
|
32.2
|
Certification
by the Principal Accounting Officer pursuant to 18 U.S.C. Section
1350.
|
SIGNATURE
In
accordance with the requirements of the Exchange Act, the registrant caused this
report to be signed on its behalf by the undersigned thereunto duly
authorized.
|
|
|
Vyteris,
Inc.
|
|
|
|
|
|
|
|
Date: November
15,
2010
|
|
/s/ Haro
Hartounian
|
|
|
|
|
Haro
Hartounian
|
|
|
|
|
Principal
Executive Officer
|
|
|
|
|
|
|
|
Date: November
15, 2010
|
|
/s/ Joseph Himy
|
|
|
|
|
Joseph
Himy
|
|
|
|
|
Principal
Financial Officer and Principal Accounting Officer
|
|
EXHIBIT
INDEX
|
Item No.
|
Description
|
|
|
|
|
31.1
|
Certification
by the Principal Executive Officer pursuant to Rule 13a-14(a) under the
Securities Exchange Act of 1934
|
|
|
|
|
31.2
|
Certification
by the Principal Accounting Officer pursuant to Rule 13a-14(a) under the
Securities Exchange Act of 1934
|
|
|
|
|
32.1
|
Certification
by the Principal Executive Officer pursuant to 18 U.S.C. Section
1350
|
|
|
|
|
32.2
|
Certification
by the Principal Accounting Officer pursuant to 18 U.S.C. Section
1350
|