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SEELOS THERAPEUTICS, INC. - Quarter Report: 2008 March (Form 10-Q)

Unassociated Document

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 March 31, 2008.

Commission file number 0-22245

NEXMED, INC.
(Exact Name of Issuer as Specified in Its Charter)

Nevada
 
87-0449967
(State or Other Jurisdiction of
 
(I.R.S. Employer
Incorporation or Organization)
 
Identification No.)

89 Twin Rivers Drive, East Windsor, NJ 08520
(Address of Principal Executive Offices)

(609) 371-8123
(Issuer’s Telephone Number, Including Area Code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Exchange Act during the preceding 12 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 o  
     
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 definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (check one): Large accelerated filer __ Accelerated filer xNon-accelerated filer ___(do not check if a smaller reporting company) Smaller reporting company ___
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o   No x
 
Indicate the number of shares outstanding of each of the issuer’s classes of common equity, as of the latest practicable date: as of May 8, 2008, 83,620,316 shares of Common Stock, par value $0.001 per share, were outstanding.


 
Table of Contents

     
Page
       
Part I. FINANCIAL INFORMATION
       
 
Item 1.
Financial Statements
1
       
   
Consolidated Balance Sheets at March 31, 2008 (unaudited) and December 31, 2007
1
       
   
Unaudited Consolidated Statements of Operations for the Three Months Ended March 31, 2008 and March 31, 2007
2
       
   
Unaudited Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2008 and March 31, 2007
3
       
   
Notes to Unaudited Consolidated Financial Statements
4
       
 
Item 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations
13
       
 
Item 3.
Quantitative and Qualitative Disclosures about Market Risk
22
       
 
Item 4.
Controls and Procedures
22
   
Part II. OTHER INFORMATION
 
       
 
Item 1.
Legal Proceedings
22
       
 
Item 1A.
Risk Factors
23
       
 
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
23
       
 
Item 6.
Exhibits
24
     
Signatures
 
25
     
Exhibit Index
 
26



PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS 

NexMed, Inc.
Consolidated Balance Sheets

   
March 31,
 
December 31,
 
   
2008
 
2007
 
   
(Unaudited)
     
           
Assets
         
Current assets:
         
Cash and cash equivalents
 
$
2,382,559
 
$
2,735,940
 
Short term investments
   
-
   
750,000
 
Debt issuance cost, net of accumulated amortization
             
of $22,694 and $7,565 - current portion
   
68,081
   
68,081
 
Prepaid expenses and other assets
   
115,849
   
127,659
 
Total current assets
   
2,566,489
   
3,681,680
 
               
Fixed assets, net
   
6,841,818
   
6,956,986
 
Debt issuance cost, net of accumulated amortization of $5,673 and $3,782
   
17,020
   
34,040
 
Total assets
 
$
9,425,327
 
$
10,672,706
 
               
Liabilities and stockholders' equity
             
Current liabilities:
             
Accounts payable and accrued expenses
 
$
604,249
 
$
621,668
 
Payroll related liabilities
   
151,430
   
693,774
 
Deferred revenue
   
1,504,542
   
953,528
 
Deferred compensation - current portion
   
61,656
   
60,929
 
Total current liabilities
   
2,321,877
   
2,329,899
 
               
Long Term liabilities:
             
Note payable, net of debt discount of $384,413 and $461,295
   
2,615,587
   
2,538,705
 
Deferred compensation
   
983,673
   
999,345
 
Total Liabilities
   
5,921,137
   
5,867,949
 
               
Commitments and contingencies (Note 7)
             
Stockholders' equity:
             
Preferred stock, $.001 par value, 10,000,000 shares authorized, none issued and outstanding
   
-
   
-
 
Common stock, $.001 par value, 120,000,000 shares authorized, 83,148,407 and 83,063,002 issued and outstanding, respectively
   
83,150
   
83,065
 
Additional paid-in capital
   
139,581,329
   
139,239,794
 
Accumulated deficit
   
(136,160,289
)
 
(134,518,102
)
Total stockholders' equity
   
3,504,190
   
4,804,757
 
               
Total liabilities and stockholders' equity
 
$
9,425,327
 
$
10,672,706
 
 
See notes to consolidated financial statements.

1

 
NexMed, Inc.
Consolidated Statements of Operations (Unaudited)

   
FOR THE THREE MONTHS ENDED
 
 
 
MARCH 31,
 
 
 
2008
 
2007
 
           
Revenues, principally license fee revenue
 
$
951,787
 
$
286,959
 
               
Operating expenses
             
Research and development
   
1,169,091
   
1,077,883
 
General and administrative
   
1,303,398
   
1,232,895
 
Total operating expenses
   
2,472,489
   
2,310,778
 
               
Loss from operations
   
(1,520,702
)
 
(2,023,819
)
               
Other expense
             
Interest expense, net
   
(121,485
)
 
(15,490
)
Total other expense
   
(121,485
)
 
(15,490
)
               
Net loss
   
(1,642,187
)
 
(2,039,309
)
               
               
               
Basic and diluted loss per share
 
$
(0.02
)
$
(0.03
)
               
Weighted average common shares outstanding used for basic and diluted loss per share
   
83,094,347
   
80,803,109
 
               
See notes to consolidated financial statements.
 
2

 
NexMed, Inc.
Consolidated Statements of Cash Flows (Unaudited)
 
   
FOR THE THREE MONTHS ENDED
MARCH 31,
 
   
2008
 
2007
 
Cash flows from operating activities
         
Net loss
 
$
(1,642,187
)
$
(2,039,309
)
Adjustments to reconcile net loss to net cash used in operating activities
             
Depreciation and amortization
   
126,595
   
171,798
 
Non-cash interest, amortization of debt discount and deferred financing costs
   
93,903
   
68,229
 
Non-cash compensation expense
   
301,870
   
358,313
 
Loss on disposal of fixed assets
   
2,605
   
-
 
Decrease in other receivable
   
-
   
183,700
 
Increase/(decrease) in prepaid expenses and other assets
   
11,810
   
(31,027
)
Increase/(decrease) in deferred revenue
   
551,014
   
(282,319
)
Decrease in payroll related liabilities
   
(542,344
)
 
(33,842
)
Decrease in deferred compensation
   
(14,945
)
 
(40,698
)
Increase/(decrease) in accounts payable and accrued expenses
   
(17,419
)
 
105,863
 
Net cash used in operating activities
   
(1,129,098
)
 
(1,539,292
)
               
Cash flow from investing activities
             
Capital expenditures
   
(14,033
)
 
-
 
Purchase of short term investments
   
-
   
(3,000,000
)
Proceeds from sale of short term investments
   
750,000
   
1,500,000
 
Net cash provided by (used in) investing activities
   
735,967
   
(1,500,000
)
               
Cash flow from financing activities
             
Issuance of common stock, net of offering costs
   
-
   
(2,110
)
Proceeds from exercise of stock options and warrants
   
39,750
   
135,689
 
Net cash provided by financing activities
   
39,750
   
133,579
 
               
Net decrease in cash and cash equivalents
   
(353,381
)
 
(2,905,713
)
               
               
Cash and cash equivalents, beginning of period
   
2,735,940
   
11,069,133
 
               
Cash and cash equivalents, end of period
 
$
2,382,559
 
$
8,163,420
 
               
See notes to consolidated financial statements.

3


NexMed, Inc.
Notes to Unaudited
Consolidated Financial Statements
 
1.
BASIS OF PRESENTATION
 
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information and with the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for annual financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair statement have been included. Operating results for the three months ended March 31, 2008 are not necessarily indicative of the results that may be expected for the year ending December 31, 2008. These financial statements should be read in conjunction with the financial statements and notes thereto contained in NexMed, Inc.’s (the “Company” or “NexMed”) Annual Report on Form 10-K for the year ended December 31, 2007.
 
The Company had an accumulated deficit of $136,160,289 at March 31, 2008 and the Company expects to incur additional losses during the remainder of 2008. As a result of our losses to date and accumulated deficit, there is doubt as to our ability to continue as a going concern, and, accordingly, our independent registered public accounting firm has modified its report on our December 31, 2007 consolidated financial statements included in our Annual Report on Form 10-K in the form of an explanatory paragraph describing the events that have given rise to this uncertainty. Management anticipates that the Company will require additional financing, which it is actively pursuing, to fund operations, including continued research, development and clinical trials of the Company’s product candidates. Although management continues to pursue such funding, there is no assurance that the Company will be successful in obtaining financing on terms acceptable to it. If additional financing cannot be obtained on reasonable terms, future operations will need to be scaled back or discontinued. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.
 
In June 2006, the FASB issued FASB Interpretation No. ("FIN") 48 "Accounting for Uncertainty in Income Taxes" ("FIN 48"). FIN 48 sets forth a recognition threshold and measurement attribute for financial statement recognition of positions taken or expected to be taken in income tax returns. The required adoption of FIN 48 as of January 1, 2007 had no material impact on the Company's consolidated financial statements. The tax years 2004-2007 remain open to examination by the major taxing jurisdictions to which we are subject.
 
2.
ACCOUNTING FOR STOCK BASED COMPENSATION
 
During December 1996, the Company adopted the NexMed, Inc. Stock Option and Long-Term Incentive Compensation Plan (“the Incentive Plan”) and the NexMed, Inc. Recognition and Retention Stock Incentive Plan (“the Recognition Plan”). A total of 2,000,000 shares were set aside for these two plans. In May 2000, the Stockholders approved an increase in the number of shares reserved for the Incentive Plan and Recognition Plan to a total of 7,500,000. During June 2006, the Company adopted the NexMed, Inc. 2006 Stock Incentive Plan. A total of 3,000,000 shares were set aside for the plan. Options granted under the Company’s plans generally vest over a period of one to five years, with exercise prices of currently outstanding options ranging from $0.55 to $16.25. The maximum term under these plans is 10 years.

4

 
Effective January 1, 2006, the Company adopted the provisions of Statement of Financial Accounting Standards No. 123R, “Share-Based Payment” (“SFAS 123R”), which establishes the financial accounting and reporting standards for stock-based compensation plans. SFAS 123R requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors, including employee stock options and restricted stock. Under the provisions of SFAS 123R, stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense on a straight-line basis over the requisite service period of the entire award (generally the vesting period of the award). The Company adopted the provisions of SFAS 123R as of January 1, 2006 using the modified prospective transition method. Under this transition method, stock-based compensation expense for the three months ended March 31, 2008 and March 31, 2007 includes expense for all equity awards granted during the three months ended March 31, 2008 and March 31, 2007 and prior, but not yet vested as of January 1, 2006, based on the grant date fair value estimated in accordance with the original provisions of SFAS No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123,”) as amended by SFAS 148, “Accounting for Stock-Based Compensation—Transition and Disclosure.” Also in accordance with the modified prospective transition method, prior interim and annual periods have not been restated and do not reflect the recognition of stock-based compensation cost under SFAS 123R. Since the adoption of SFAS 123R, there have been no changes to the Company’s stock compensation plans or modifications to outstanding stock-based awards which would increase the value of any awards outstanding. Compensation expense for all stock-based compensation awards granted subsequent to January 1, 2006 was based on the grant-date fair value determined in accordance with the provisions of SFAS 123R.
 
As a result of adopting SFAS 123R, the Company’s net loss and its non-cash compensation expense as shown in the Consolidated Statements of Operations for the three months ended March 31, 2008 and March 31, 2007 is more by $301,870 and $298,313, respectively, than if the Company had continued to account for stock-based compensation under Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”) and its related interpretations. Basic and diluted net loss per share for the three months ended March 31, 2008 and March 31, 2007 is more by $0.004 in both periods than if the Company had not adopted SFAS 123R.
 
5

 
The following table indicates where the total stock-based compensation expense resulting from stock options and awards appears in the Statement of Operations (unaudited):
 
   
Three Months
 
Three Months
 
   
Ended
 
Ended
 
   
March 31, 2008
 
March 31, 2007
 
           
Research and development
 
$
9,183
 
$
24,966
 
General and administrative
   
292,687
   
273,347
 
 
             
Stock-based compensation expense
 
$
301,870
 
$
298,313
 
               
 
The stock-based compensation expense has not been tax-effected due to the recording of a full valuation allowance against U.S. net deferred tax assets.
 
The Company accounts for stock and stock options granted to non-employees on a fair value basis in accordance with SFAS No. 123, "Accounting for Stock-Based Compensation," and Emerging Issues Task Force Issue No. 96-18, "Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services." Any stock or stock options issued to non-employees are recorded in the consolidated financial statements using the fair value method and then amortized to expense over the applicable service periods. As a result, the non-cash charge to operations for non-employee options with vesting or other performance criteria is valued each reporting period based upon changes in the fair value of the Company's common stock.
 
The fair value of each stock option grant is estimated on the grant date using the Black-Scholes option-pricing model with the following assumptions used for the three month periods ended March 31, 2008 and March 31, 2007:

Dividend yield
0.00%
Risk-free yields
1.35% - 5.02%
Expected volatility 
80% - 103.51%
Expected option life 
1 - 6 years
Forfeiture rate 
6.41%
 
Expected Volatility. The Company uses analysis of historical volatility to compute the expected volatility of its stock options.
 
Expected Term. The expected term is based on several factors including historical observations of employee exercise patterns during the Company’s history and expectations of employee exercise behavior in the future giving consideration to the contractual terms of the stock-based awards.

6

 
Risk-Free Interest Rate. The interest rate used in valuing awards is based on the yield at the time of grant of a U.S. Treasury security with an equivalent remaining term.
 
           Dividend Yield. The Company has never paid cash dividends, and does not currently intend to pay cash dividends, and thus has assumed a 0% dividend yield.
 
           Pre-Vesting Forfeitures. Estimates of pre-vesting option forfeitures are based on Company experience. The Company will adjust its estimate of forfeitures over the requisite service period based on the extent to which actual forfeitures differ, or are expected to differ, from such estimates. Changes in estimated forfeitures will be recognized through a cumulative catch-up adjustment in the period of change and will also impact the amount of compensation expense to be recognized in future periods. The cumulative effect resulting from initially applying the provisions of SFAS 123R to nonvested equity awards was not significant. The Company’s current forfeiture rate is 6.41%.
 
Stock Options and Restricted Stock
 
Presented below is a summary of the status of Company stock options as of March 31, 2008, and related transactions for the three month period then ended (unaudited):

       
 
 
 
 
 
 
       
Weighted
Average
 
Weighted
Average Remaining
 
Total
Aggregate
 
   
Number of
 
Exercise
 
Contractual
 
Intrinsic
 
   
Shares
 
Price
 
Life
 
Value
 
Outstanding at December 31, 2007
   
3,469,841
                   
Granted
   
-
 
$
-
             
Exercised
   
(55,000
)
$
0.73
             
Cancelled
   
(5,850
)
$
11.78
             
Outstanding at March 31, 2008
   
3,408,991
 
$
1.40
   
6.94 years
 
$
1,410,738
 
Vested or expected to vest at March 31, 2008
   
3,190,475
 
$
1.40
   
6.94 years
 
$
1,320,310
 
Exercisable at March 31, 2008
   
3,062,590
 
$
1.43
   
6.73 years
 
$
1,347,537
 
 
7

 
 
 
Options Outstanding
 
Options Exercisable
 
       
Weighted Average
     
Aggregate
         
Aggregate
 
Range of
 
Number
 
Remaining
 
Weighted Average
 
Intrinsic
 
Number
 
Weighted Average
 
Intrinsic
 
Exercise Prices
 
Outstanding
 
Contractual Life
 
Exercise Price
 
Value
 
Exercisable
 
Exercise Price
 
Value
 
$ .55 - 1.85
   
2,878,090
   
7.52 years
 
$
0.87
 
$
1,410,738
 
$
2,531,689
 
$
0.82
 
$
1,347,537
 
2.00 - 3.99
   
139,250
   
2.84 years
   
2.83
   
-
   
139,250
   
2.83
   
-
 
4.00 - 5.50
   
373,651
   
4.26 years
   
4.65
   
-
   
373,651
   
4.65
   
-
 
7.00 - 12.00
   
18,000
   
2.18 years
   
8.67
   
-
   
18,000
   
8.67
   
-
 
     
3,408,991
       
$
1.40
 
$
1,410,738
 
$
3,062,590
 
$
1.43
 
$
1,347,537
 
 
The weighted-average grant-date fair value of options granted during the three months ended March 31, 2008 and March 31, 2007 was $0.00 and $0.85, respectively. The intrinsic value (the difference between the aggregate exercise price and the closing price of our common stock on the date of exercise) on the exercise date of options exercised during the three months ended March 31, 2008 and 2007 was $43,270 and $8,529, respectively. Cash received from option exercises for the three months ended March 31, 2008 and March 31, 2007, was $39,750 and $15,664, respectively.
 
On January 9, 2008 the Company issued awards of shares of the Company’s common stock to each independent director as compensation for their services during the year ending December 31, 2008. In lieu of cash compensation, the Independent Directors have opted to receive, and the Board of Directors has approved, a full grant of 24,324 shares of the Company's common stock to each Independent Director for his services to be rendered to the Board of Directors during the 2008 calendar year. The price per share (the "Price") is the average of the closing price of the Company's common stock over five consecutive trading days, commencing on January 2, 2008. The number of the full grant of shares was calculated based on the amount of cash the Director would have received for annual service on the Board, or $36,000 divided by the Price.
 
Of the 24,324 shares being granted to each Independent Director, 2,027 of such shares will vest each month during calendar 2008. As such, for the quarter ended March 31, 2008, 6,081 shares vested and were issued to each Independent Director. Although the Board of Directors has approved the full grant of 24,324 shares to each Independent Director for the 2008 calendar year, only 6,081 shares have been issued and the remaining 18,243 shares granted for the remainder of the 2008 calendar year are subject to issuance following shareholder approval of a proposed amendment to the Company’s 2006 Stock Incentive Plan. 
 
8

 
3. LOSS PER SHARE
 
At March 31, 2008 and 2007, respectively, options to acquire 3,408,991 and 3,372,841 shares of common stock with exercise prices ranging from $.55 to $16.25 per share and warrants to acquire 12,439,954 and 20,022,527 shares of common stock with exercise prices ranging from $0.55 to $3.00 were excluded from the calculation of diluted loss per share, as their effect would be anti-dilutive. Loss per share for the three months ended March 31, 2008 and 2007 was calculated as follows (net loss / weighted average common shares outstanding):

   
FOR THE THREE MONTHS 
ENDED MARCH 31,
 
   
2008
 
2007
 
Net loss
  $
(1,642,187
)
$
(2,039,309
)
 
             
Weighted average common shares outstanding used for basic and diluted loss per share
   
83,094,347
   
80,803,109
 
Basic and diluted loss per common share
 
$
(0.02
)
$
(0.03
)

4. NOTE PAYABLE
 
October 2007 Note
 
On October 26, 2007 the Company issued a note in a principal amount of $3 million. The note is payable on June 30, 2009 and can be prepaid by the Company at any time without penalty. Interest accretes on the note on a quarterly basis at a rate of 8.0% per annum. The note is collateralized by the Company’s facility in East Windsor, New Jersey.
 
The Company also issued to the noteholder a 5-year detachable warrant to purchase 450,000 shares of common stock at an exercise price of $1.52. Of the total warrants issued, 350,000 warrants vested immediately and the remaining 100,000 warrants will vest if the note remains outstanding on October 26, 2008. The Company valued the warrants using the Black-Scholes pricing model. The Company allocated a relative fair value of $512,550 to the warrants. The relative fair value of the warrants is allocated to additional paid-in capital and treated as a discount to the note that is being amortized over the 20-month period ending June 30, 2009.
 
For the three months ended March 31, 2008, the Company recorded $76,883 of amortization related to the note discount.

9


November 2006 Note
 
On November 30, 2006, the Company issued a note in the principal amount of $2 million that was paid off on October 29, 2007. The note was payable on the earlier of December 31, 2007 or the closing by the Company on the sale of the Company’s facility in East Windsor, New Jersey. Interest accreted on the note on a quarterly basis at a rate of 7.5% per annum provided, however, if the Company had not entered into a contract of sale of the East Windsor property on or prior to May 31, 2007, and the note had not been repaid by such date, the interest rate would increase to 8.5%. As such, on May 31, 2007, the interest rate increased to 8.5%.
 
On February 28, 2007, the Company issued 28,809 shares of its common stock as payment of an aggregate of $25,000 in interest on the note.
 
The Company also issued the noteholder a 4-year detachable warrant to purchase 500,000 shares of common stock at an exercise price of $0.5535. The Company valued the warrants using the Black-Scholes pricing model. The Company allocated a relative fair value of $138,000 to the warrants. The relative fair value of the warrants was allocated to additional paid-in capital and treated as a discount to the note that was being amortized through the October 2007 repayment date.
 
This note was paid on October 29, 2007 with the proceeds from the issuance of the $3 million note referred to above. The Company paid in cash the $2 million balance on the Note plus accrued interest of $42,028.
 
For the three months ended March 31, 2007, the Company recorded $31,846 of amortization related to the note discount.
 
5.
DEFERRED COMPENSATION
 
On February 27, 2002, the Company entered into an employment agreement with Y. Joseph Mo, Ph.D., that had a constant term of five years, and pursuant to which Dr. Mo would serve as the Company's Chief Executive Officer and President. Under the employment agreement, Dr. Mo was entitled to deferred compensation in an annual amount equal to one sixth of the sum of his base salary and bonus for the 36 calendar months preceding the date on which the deferred compensation payments commenced subject to certain limitations, including annual vesting through January 1, 2007, as set forth in the employment agreement. The deferred compensation is payable monthly for 180 months commencing on termination of employment. Dr. Mo’s employment was terminated as of December 15, 2005. At such date, the Company accrued deferred compensation of $1,178,197 based upon the estimated present value of the obligation. The monthly deferred compensation payment through May 15, 2021 is $9,158. As of March 31, 2008, the Company has accrued $1,045,329 in deferred compensation.
 
6. INCOME TAXES  
 
In consideration of the Company’s accumulated losses and lack of historical ability to generate taxable income, the Company has determined that it will not be able to realize any benefit from its temporary differences between book income and taxable income in the foreseeable future, and has recorded a valuation allowance of an equal amount to fully offset the deferred tax benefit amount.

10

 
7.  COMMITMENTS AND CONTINGENCIES
 
The Company is a party to clinical research agreements in connection with a one-year open-label study for its topical alprostadil-based cream treatment for erectile dysfunction (“ED Product”) with commitments by the Company that initially totaled approximately $12.8 million. These agreements were amended in October 2005 such that the total commitment was reduced to approximately $4.2 million. These agreements provide that if the Company cancels them prior to 50% completion, the Company will owe the higher of 10% of the outstanding contract amount prior to the amendment or 10% of the outstanding amount of the amended contract at the time of cancellation. At March 31, 2008, such amount is approximately $1.1 million.
 
8. LICENSING AGREEMENTS
 
On November 1, 2007, the Company signed an exclusive licensing agreement with Warner Chilcott Company, Inc. (“Warner”) for its topical alprostadil-based cream treatment for erectile dysfunction (“ED Product”). Under the agreement, Warner acquired the exclusive rights in the United States to the ED Product and will assume all further development, manufacturing, and commercialization responsibilities as well as costs. Warner agreed to pay the Company an up front payment of $500,000 and up to $12.5 million in milestone payments on the achievement of specific regulatory milestones. In addition, the Company is eligible to receive royalties in the future based upon the level of sales achieved by Warner, assuming the FDA approves the product.
 
The Company is recognizing the initial up-front payment as revenue on a straight-line basis over the estimated 9-month period ending July 31, 2008 which is the remaining anticipated review time by the FDA for the Company’s new drug application filed in September 2007 for the ED Product. Pursuant to the agreement, NexMed is responsible for the regulatory approval of the ED Product. Accordingly, for the three months ended March 31, 2008, the Company recognized licensing revenue of $166,667 related to the Warner agreement.
 
On September 15, 2005, the Company signed an exclusive global licensing agreement with Novartis International Pharmaceutical Ltd., (“Novartis”) for its topical nail solution for the treatment of onychomycosis (nail fungal infection), NM100060. Under the agreement, Novartis acquired the exclusive worldwide rights to NM100060 and assumed all further development, regulatory, manufacturing and commercialization responsibilities as well as costs. Novartis agreed to pay the Company up to $51 million in up-front and milestone payments on the achievement of specific development and regulatory milestones, including an initial cash payment of $4 million at signing. In addition, the Company is eligible to receive royalties based upon the level of sales achieved and is entitled to receive reimbursements of third party preclinical study costs of up to $3.25 million. The Company began recognizing the initial up-front and preclinical reimbursement revenue from this agreement based on the cost-to-cost method over the 32-month period estimated to complete the remaining preclinical studies for NM100060. On February 16, 2007, the Novartis agreement was amended. Pursuant to the amendment, the Company is no longer obligated to complete the remaining preclinical studies for NM100060. Novartis has taken over all responsibilities related to the remaining preclinical studies. As such, the balance of deferred revenue of $1,693,917 at December 31, 2006 is being recognized as revenue on a straight-line basis over the 18-month period ending June 30, 2008, which is the estimated performance period for Novartis to complete the remaining preclinical studies. Accordingly, for the three months ended March 31, 2008, the Company recognized licensing revenue of $282,319 related to the initial cash payment at signing.
 
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On March 4, 2008, the Company received a $1.5 million milestone payment from Novartis pursuant to the terms of the licensing agreement whereby the payment was due seven months after the completion of patient enrollment for the Phase 3 clinical trials for NM100060, which occurred in July 2007. Although the completion of patient enrollment in the ongoing Phase 3 clinical trials for NM100060 triggers a $3 million milestone payment from Novartis, the agreement also provides that clinical milestones paid to us by Novartis shall be reduced by 50% until we receive an approved patent claim on the NM100060 patent application filed with the U.S. patent office in November 2004. The $1.5 million milestone is being recognized on a straight-line basis over the estimated remaining six months to complete the Phase 3 clinical trial. Accordingly, for the three months ended March 31, 2008, the Company recognized licensing revenue of $500,000 related to the $1.5 million milestone payment.
 
9. SUBSEQUENT EVENTS
 
On April 25, 2008, the Company adjusted the warrant price for holders of warrants dated January 23, 2006 who wished to exercise their warrants and purchase shares of the Company’s common stock for cash only. The warrant price was adjusted from $1.11 to $0.89 for the three day period ended April 29, 2008. The Company received proceeds of approximately $420,000 upon the issuance of 471,909 shares of the Company’s common stock upon the exercise of such warrants.
 
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ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
Disclosures Regarding Forward-Looking Statements.

The following should be read in conjunction with the unaudited consolidated financial statements and the related notes that appear elsewhere in this document as well as in conjunction with the Risk Factors section of our Form 10-K filed with the Securities and Exchange Commission on March 12, 2008. This report includes forward-looking statements made based on current management expectations pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are not guarantees of future performance and actual outcomes may differ materially from what is expressed or forecast. There are many factors that affect our business, consolidated financial position, results of operations and cash flows, including but not limited to, our ability to enter into partnering agreements or raise financing on acceptable terms, successful completion of clinical development programs, regulatory review and approval, product development and acceptance, manufacturing, competition, and/or other factors, many of which are outside our control.

General.

We are a Nevada corporation and have been in existence since 1987. Since 1994, we have positioned ourselves as a pharmaceutical and medical technology company with a focus on developing and commercializing therapeutic products based on proprietary delivery systems. We are currently focusing our efforts on new and patented topical pharmaceutical products based on a penetration enhancement drug delivery technology known as NexACT®, which may enable an active drug to be better absorbed through the skin.
 
The NexACT® transdermal drug delivery technology is designed to enhance the absorption of an active drug through the skin, overcoming the skin's natural barrier properties and enabling high concentrations of the active drug to rapidly penetrate the desired site of the skin or extremity. Successful application of the NexACT® technology would improve therapeutic outcomes and reduce systemic side effects that often accompany oral and injectable medications. We have applied the NexACT® technology to a variety of compatible drug compounds and delivery systems, and, on our own or through development partnerships, are in various stages of developing new topical treatments for male and female sexual dysfunction, nail fungus, psoriasis, and other dermatological conditions. We intend to continue our efforts developing topical treatments based on the application of NexACT® technology to drugs: (1) previously approved by the FDA, (2) with proven efficacy and safety profiles, (3) with patents expiring or expired and (4) with proven market track records and potential.

On June 18, 2007, Vivian H. Liu was appointed as our Chief Executive Officer. Ms. Liu succeeded Richard J. Berman, who was elected by the Board to serve as its non-executive Chairman. Mr. Berman was our interim Chief Executive Officer from January 2006 through June 2007 and has served as a Director of NexMed since 2002. At the Annual Meeting of Stockholders on June 18, 2007, Ms. Liu was also elected to serve on the Board of Directors for a three-year term. On November 2, 2007, we announced the appointment of Mr. Hemanshu Pandya to the position of Vice President and Chief Operating Officer. In addition, we have formed a Scientific Advisory Board headed by Dr. David Tierney, who also serves as a Director on the Board of Directors. The focus of the Scientific Advisory Board is to assist us in evaluating our current pipeline consisting of early stage NexACT® based products under development, and also assist us in identifying and evaluating new product development opportunities going forward.  

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We have an exclusive global licensing agreement with Novartis International Pharmaceutical Ltd. (“Novartis”) for NM100060, our proprietary topical nail solution for the treatment of onychomycosis (nail fungal infection). Under the agreement, Novartis acquired the exclusive worldwide rights to NM100060 and has assumed all further development, regulatory, manufacturing and commercialization responsibilities as well as costs. Novartis agreed to pay us up to $51 million in upfront and milestone payments on the achievement of specific development and regulatory milestones, including an initial cash payment of $4 million at signing. In addition, we are eligible to receive royalties based upon the level of sales achieved.

On July 9, 2007, we announced that Novartis had completed patient enrollment for the Phase 3 clinical trials for NM100060. The Phase 3 program for NM100060 consists of two pivotal, randomized, double-blind, placebo-controlled studies. The parallel group studies are designed to assess the efficacy, safety and tolerability of NM100060 in patients with mild to moderate toenail onychomycosis. Approximately 1,000 patients are enrolled in the two studies, which are taking place in the U.S., Europe, Canada and Iceland.

The Phase 3 program is expected to be completed in mid-2008, and top line results should be available to us in early Fall 2008, with Novartis planning to file the New Drug Application (“NDA”) in the U.S. before the end of 2008 if the Phase 3 trial data is successful. If the trial is successful, we will receive significant cash infusions from Novartis before year-end. Per the agreement, we will receive a $6 million milestone payment for positive Phase 3 results and a $7 million and $3 million milestone payment for the filing of the NDA in the U.S. and the Marketing Authorization Application (“MAA”) in Europe, respectively. However, there is no certainty that the Phase 3 trial will be successful. Should the Phase 3 trial be unsuccessful then we will not receive any of the $16 million stated above and the licensing agreement with Novartis will most likely be terminated.

The completion of patient enrollment in the ongoing Phase 3 clinical trials for NM100060 has triggered a $3 million milestone payment from Novartis. Pursuant to the terms of the licensing agreement with Novartis, this payment was due on February 4, 2008, or 7 months after last patient enrolled in the Phase 3 studies. However, the agreement also provides that clinical milestones paid to us by Novartis shall be reduced by 50% until we receive an approved patent claim on the NM100060 patent application which we filed with the U.S. patent office in November 2004. As such, we received $1.5 million from Novartis on March 4, 2008. Based on the Office Actions received to-date, we expect to receive an approved patent claim before the end of the third quarter of 2008. When we file the patent issuance fee, it would trigger an additional $2 million patent milestone due from Novartis, and cause Novartis to release the balance of $1.5 million remaining from the $3 million patient enrollment milestone. However, there is no certainty that we will receive an approved patent claim for NM100060 this year or at all.

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In March 2007, Novartis commenced a comparator study in ten European countries. Over 900 patients with mild to moderate onychomycosis are participating in this open-label study, which is designed to assess the safety and tolerability of NM100060 (terbinafine 10% topical formulation) versus Loceryl® (amorolfine) 5% nail lacquer, a topical treatment for onychomycosis that is approved in Europe. The comparator study is expected to be completed by early 2009 and the data will be included in the MAA, which is currently scheduled to be filed after the U.S. filing for approval.    

The most advanced of our products under development is our topical alprostadil-based cream treatment intended for patients with erectile dysfunction (the “ED Product”), which was previously known as Alprox-TD®. Our NDA was filed and accepted for review by the FDA in September and November 2007, respectively. As such, according to the Prescription Drug User Fees Act (“PDUFA”), the FDA’s expected target action date regarding approval of our NDA is July 19, 2008, assuming the FDA does not require any significant additional studies or information during the review process.

On November 1, 2007, we licensed the U.S. rights of our ED Product to Warner Chilcott Company, Inc. (“Warner”). Warner paid us $500,000 upon signing and agreed to pay us up to $12.5 million on the achievement of specific regulatory milestones and will undertake the manufacturing investment and any other investment for further product development that may be required for product approval, including an estimated $2 million for improvements to our East Windsor manufacturing facility in order for the facility to be ready for commercial manufacturing. Additionally, Warner is responsible for the commercialization of our ED Product. However, should Warner determine that it does not wish to continue the regulatory approval process for our ED Product, the licensing agreement would terminate, and the U.S. rights to the ED Product would revert back to us.
 
The NDA for our ED Product is based on a formulation that requires refrigeration for stability. We have developed the prototype for a non-refrigerated ED Product. We estimate that $5 million will have to be invested in the scale-up (developing the prototype to production level) of the room temperature version of the ED Product. Pursuant to the Warner contract, Warner would fund the development expenses for the room temperature ED Product if Warner and NexMed jointly decide to switch to the room temperature ED Product for commercialization.

In terms of the NDA filing in the U.S., we have taken the regulatory position that the long term safety data for the ED Product should be based on our clinical database of over 3,000 patients, instead of a 12-month open-label study as indicated by ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidance. We did not obtain the FDA’s opinion of our regulatory position prior to our filing the NDA for the ED Product. As such, we will learn whether the FDA agrees with our position as they are reviewing our NDA. We currently estimate the cost to complete a 12 month open-label study to be approximately $8 million. Warner will undertake the investment necessary to complete the 12 month open-label study should it be required by the FDA. However, should Warner determine that it does not wish to seek further regulatory approval of our ED Product then the licensing agreement would terminate and all rights would revert back to us. There is always the risk that we will not be successful in convincing the FDA to approve the product for marketing.

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In January 2008, the FDA began and completed the pre-approval inspection (“PAI”) of our facility, which is a requirement upon the filing of the NDA for our ED Product. The PAI is conducted by the FDA to ensure that our facility is in compliance with Good Manufacturing Practices (“GMP”) as defined by FDA regulations and to determine if we have the ability to begin commercial manufacturing upon approval of the NDA. The PAI was completed with certain observations made by the FDA and a withhold status was placed on the facility, which means that the facility is currently not approved by the FDA for commercial manufacturing. However, the withhold status does not prevent the FDA from reviewing other components of the NDA for approval of our ED product. We are responding to their observations in a timely manner in order to ensure that our facility is compliant with GMP well in advance of commercial manufacturing. While Warner intends to manufacture our ED Product in the future, our facility is listed as the manufacturing and quality control laboratory in the NDA and will likely be the initial site for commercial manufacturing of our ED Product upon its approval for commercialization.

On February 21, 2007, the Canadian regulatory authority, Health Canada, informed us that the lack of a completed 12-month open label safety study would not preclude them from accepting and reviewing our New Drug Submission (“NDS”) in Canada which was accepted for review on February 15, 2008. On May 2, 2008, we announced that our manufacturing facility received a GMP compliance certification from Health Canada, which is essential for the ultimate approval and marketing of our ED Product in Canada. The review and approval process in Canada typically takes about 12 months. Even though we are encouraged by the initial positive feedback from Health Canada, the risk remains that we may not be successful in convincing them to approve our product for marketing.

On April 20, 2007, the United Kingdom regulatory authority, Medicines and Healthcare Products Regulatory Agency (the “MHRA”) also informed us that the safety data that we have compiled to date was sufficient for the MAA to be filed and accepted for review in the United Kingdom. We had another guidance meeting with the MHRA in January 2008 and received additional input for the preparation of our MAA. However, the MHRA informed us at that time that due to the backlog of MAA filings, they would not be able to receive and start reviewing our MAA until February 2009. As a result of the MHRA’s backlog, we are evaluating the possibility of using another reference state for our filing under the mutual recognition system to accelerate the filing in Europe. Even though we are encouraged by the initial positive feedback from the MHRA, the risk remains that we may not be successful in convincing the MHRA and other European regulatory authorities to approve our product for marketing.

We are also developing Femprox®, which is an alprostadil-based cream product intended for the treatment of female sexual arousal disorder. We have completed nine clinical studies to date, including one 98-patient Phase 2 study in the U.S. for Femprox®, and also a 400-patient study for Femprox® in China, where the cost for conducting clinical studies is significantly lower than in the U.S. We do not intend to conduct additional studies for this product until we have secured a co-development partner, which we are actively seeking.

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We have also continued early stage development work for our product pipeline with the goal of focusing our attention on product opportunities that would replicate the model of our licensed anti-fungal nail treatment. Our current efforts are focused on the development of viable topical treatments for psoriasis, a common dermatological condition.
 
Patents.

We have thirteen U.S. patents either acquired or received out of a series of patent applications that we have filed in connection with our NexACT® technology and our NexACT® -based products under development. To further strengthen our global patent position on our proprietary products under development, and to expand the patent protection to other markets, we have filed under the Patent Cooperation Treaty corresponding international applications for our issued U.S. patents and pending U.S. patent applications.

The following table identifies our thirteen U.S. patents issued for NexACT® technology and/or our NexACT®-based products under development, and the year of expiration for each patent. In addition, we have over 200 international patents and U.S. and international patent applications pending.
 
Patent Name
 
Expiration Date
 
       
Biodegradable Absorption Enhancers
   
2008
 
Biodegradable Absorption Enhancers
   
2009
 
Compositions and Methods for Amelioration of Human Female Sexual Dysfunction
   
2017
 
Topical Compositions for PGE1 Delivery
   
2017
 
Topical Compositions for Non-Steroidal Anti-Inflammatory Drug Delivery
   
2017
 
Prostaglandin Compositions & Methods of Treatment for Male Erectile Dysfunction
   
2017
 
Medicament Dispenser
   
2019
 
Crystalline Salts of dodecyl 2-(N, N-Dimethylamino) *
   
2019
 
Topical Compositions Containing Prostaglandin E1
   
2019
 
CIP: Topical Compositions Containing Prostaglandin E1
   
2019
 
Prostaglandin Composition and Methods of Treatment of Male Erectile Dysfunction
   
2020
 
CIP: Prostaglandin Composition and Methods of Treatment of Male Erectile Dysfunction
   
2020
 
Topical Stabilized Prostaglandin E Compound Dosage Forms
   
2023
 
 
* Composition of matter patent on our NexACT® technology which is included in all of our current products under development
 
The two patents covering the first generation of the NexACT® technology enhancer will expire in 2008 and 2009. However, our current products under development contain the second generation of the NexACT® technology which is protected by a patent that will expire in 2019.

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While we have obtained patents and have several patent applications pending, the extent of effective patent protection in the U.S. and other countries is highly uncertain and involves complex legal and factual questions. No consistent policy addresses the breadth of claims allowed in or the degree of protection afforded under patents of medical and pharmaceutical companies. Patents we currently own or may obtain might not be sufficiently broad to protect us against competitors with similar technology. Any of our patents could be invalidated or circumvented.

While we believe that our patents would prevail in any potential litigation, the holders of competing patents could determine to commence a lawsuit against us and even prevail in any such lawsuit. Litigation could result in substantial cost to and diversion of effort by us, which may harm our business. In addition, our efforts to protect or defend our proprietary rights may not be successful or, even if successful, may result in substantial cost to us.

Research and Development.

Governmental authorities in the U.S. and other countries heavily regulate the testing, manufacture, labeling, advertising, marketing and distribution of our proposed products. None of our proprietary products under development have been approved for marketing in the U.S. Before we market any products we develop, we must obtain FDA and comparable foreign agency approval through an extensive clinical study and approval process.

The studies involved in the approval process are conducted in three phases. In Phase 1 studies, researchers assess safety or the most common acute adverse effects of a drug and examine the size of doses that patients can take safely without a high incidence of side effects. Generally, 20 to 100 healthy volunteers or patients are studied in the Phase 1 study for a period of several months. In Phase 2 studies, researchers determine the drug's efficacy and short-term safety by administering the drug to subjects who have the condition the drug is intended to treat. At the conclusion of the study, an assessment of the correct dosage level and whether the drug favorably affects the condition is made. Up to several hundred subjects may be studied in the Phase 2 study for approximately 6 to 12 months, depending on the type of product tested. In Phase 3 studies, researchers further assess efficacy and safety of the drug. Several hundred to thousands of patients may be studied during the Phase 3 studies for a period lasting from 12 months to several years. Upon completion of Phase 3 studies, an NDA may be submitted to the FDA or foreign governmental regulatory authority for review and approval.

Our failure to obtain requisite governmental approvals in a timely manner, or at all, will delay or preclude us from licensing or marketing our products or limit the commercial use of our products, which could adversely affect our business, financial condition and results of operations.

Because we intend to sell and market our products outside the U.S., we will be subject to foreign regulatory requirements governing the conduct of clinical trials, product licensing, pricing and reimbursements. These requirements vary widely from country to country. Our failure to meet a foreign country's requirements could delay the introduction of our proposed products in such foreign country and limit our revenues from sales of our proposed products in foreign markets.

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Successful commercialization of our products may depend on the availability of reimbursement to consumers from third-party healthcare payers, such as government and private insurance plans. Even if we succeed in bringing one or more products to market, reimbursement to consumers may not be available or sufficient to allow us to realize an appropriate return on our investment in product development or to sell our products on a competitive basis. In addition, in certain foreign markets, pricing or profitability of prescription pharmaceuticals is subject to governmental controls. In the U.S., federal and state agencies have proposed similar governmental control and the U.S. Congress has recently considered legislative and regulatory reforms that may affect companies engaged in the healthcare industry. Pricing constraints on our products in foreign markets and possibly in the U.S. could adversely affect our business and limit our revenue.
 
Liquidity, Capital Resources and Financial Condition.
 
We have experienced net losses and negative cash flows from operations each year since our inception. Through March 31, 2008, we had an accumulated deficit of $136,160,289. Our operations have principally been financed through private placements of equity securities and debt financing. Funds raised in past periods should not be considered an indication of our ability to raise additional funds in any future periods.

As a result of our losses to date and accumulated deficit, there is doubt as to our ability to continue as a going concern, and, accordingly, our independent registered public accounting firm has modified its report on our December 31, 2007 consolidated financial statements included in our Annual Report on Form 10-K in the form of an explanatory paragraph describing the events that have given rise to this uncertainty. These factors may make it more difficult for us to obtain additional funding to meet our obligations. Our ability to continue as a going concern is based on our ability to generate or obtain sufficient cash to meet our obligations on a timely basis and ultimately become profitable.
 
At March 31, 2008 we had cash and cash equivalents and short term investments of approximately $2.4 million as compared to $3.5 million at December 31, 2007. The reduction in our cash balance in 2008 was partially offset by the receipt of a $1.5 million milestone payment from Novartis on March 4, 2008 for the completion of patient enrollment in the Phase 3 trials of NM100060, as discussed in Note 8 of the Consolidated Financial Statements. Our net decrease in cash in the first three months of 2008 is due to our average fixed monthly overhead costs of approximately $525,000 per month, in addition to approximately $600,000 for 2007 bonuses which were paid to employees in March 2008. Additionally, we spent approximately $300,000 to support our NDA and NDS filings for our topical ED Product.

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Our cash reserves of $1.8 million as of the date of this report provide us with sufficient cash to fund our operations through August 2008 based on our projected 2008 monthly overhead costs of approximately $525,000. We will receive a total of $3.5 million from Novartis when we receive the approved claim on the NM100060 patent application. The $3.5 million anticipated payment is comprised of the balance of $1.5 million due from the patient enrollment milestone as well as a $2 million patent milestone. Based on our most recent discussions with the U.S. Patent Office, we expect our patent to be allowed before the end of August 2008, thereby providing sufficient cash reserves to fund our operations into the first quarter of 2009. However, there is no certainty that we will receive an approved patent claim for NM100060 this year or at all. Should we not receive an approved patent claim, it may be necessary to obtain additional funding to continue our operations in 2008. We do not intend to trigger the approximately $1.2 million in direct expenditures budgeted for our early stage products under development until we have significantly improved our cash position. 

On March 5, 2008 we executed a non-binding term sheet with a potential buyer to close a sale-leaseback transaction on our East Windsor, New Jersey facility in the second quarter of 2008 at a purchase price of $7 million. The closing of this transaction in the second quarter, along with our current cash reserves would provide sufficient funding for our operations to the end of 2008, and with the $3.5 million payment for the patent allowance, through the second quarter of 2009. However, there is no assurance that we can agree on terms and close this transaction in the second quarter of 2008 or at all.

Before the end of 2008, we expect significant cash infusions from Novartis assuming the Phase 3 trial for NM100060 is successful. We will receive a $6 million milestone payment from Novartis if the results from the Phase 3 trials are positive and a $7 million and $3 million milestone payment upon the filings of the NDA in the U.S. and MAA in Europe, respectively. However, there is no certainty that the Phase 3 trial will be successful. Should the Phase 3 trial be unsuccessful then we will not receive any of the $16 million stated above and the licensing agreement with Novartis will most likely be terminated.
 
At March 31, 2008, we had $151,430 in payroll related liabilities as compared to $693,774 at December 31, 2007. The decrease is attributable to the payment of 2007 bonuses in March 2008. Our bonuses were accrued and expensed in 2007 but were not paid until the first quarter of 2008.
 
To date, we have spent approximately $71 million on our ED Product development program. Pursuant to our license agreement signed on November 1, 2007, Warner will undertake the manufacturing investment and any other investment for further product development that may be required for product approval in the United States. We anticipate that the remaining cost to prepare all of the relevant dossiers and assemble the regulatory approval applications in Europe will be approximately $500,000. We do not intend to trigger those expenses until we significantly improve our cash reserves or engage a partner in Europe to undertake these expenses.
 
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Critical Accounting Estimates.

Our discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires our management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. Our accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements. Actual results could differ from these estimates. There have been no material changes to our Critical Accounting Policies described in our Form 10-K filed with the Securities and Exchange Commission on March 12, 2008.

Comparison of Results of Operations Between the Three Months Ended March 31, 2008 and 2007.
 
Revenue, principally license fee revenue. We recorded $951,787 in revenue during the first quarter of 2008, as compared to $286,959 in revenue during the first quarter of 2007. The increase in revenue is primarily due to the $500,000 in revenue recognized related to the $1.5 million milestone payment received from Novartis on March 4, 2008 as discussed in Note 8 of the Consolidated Financial Statements. Additionally, the increase in revenue in 2008 is the result of the $166,667 in revenue recognized in 2008 attributable to the up-front payment received in November 2007 from Warner as discussed in Note 8 of the Consolidated Financial Statements.

Research and Development Expenses. Our research and development expenses for the first quarter of 2008 and 2007 were $1,169,091 and $1,077,883, respectively. Research and development expenses in the first quarter of 2008 included approximately $429,000 attributable to our ED Product and the balance attributable to other NexACT® technology based products and indirect overhead related to research and development, as compared to approximately $335,000 for our ED Product during the same period in 2007.

General and Administrative Expenses. Our general and administrative expenses were $1,303,398 during the first quarter of 2008 as compared to $1,232,895 during the same period in 2007. The slight increase is primarily due to an increase of approximately $100,000 in legal fees related to the national filings of patent applications for our ED Product as well as legal fees in connection with a patent lawsuit in which we are the plaintiff suing for patent infringement of our herpes treatment medical device. There was also an increase in salaries of approximately $50,000 due to the addition of our Chief Operating Officer in late 2007 and the appointment of our Chief Executive Officer in June 2007. The increases were partially offset by a reduction in consulting fees of approximately $78,000 as our Chief Operating Officer and Chief Executive Officer have taken over most of the responsibilities handled by consultants in 2007.
 
Interest Expense, Net. We had interest expense net of interest income of $121,485 during the first quarter of 2008, as compared to $15,490 during the same period in 2007. The increase is primarily due to the $3 million mortgage note executed in October 2007 as discussed in Note 4 of the Consolidated Financial Statements whereby we amortized $76,883 of the note discount in 2008. Additionally, we recorded more interest income in 2007 because our cash balance at March 31, 2007 was higher than at March 31, 2008.

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 Net Loss. The net loss was $1,642,187 or $0.02 per share and $2,039,309 or $0.03 per share in the first quarter of 2008 and 2007, respectively. The decrease is primarily attributable to the increase in revenue as a result of the $500,000 in revenue recognized as a result of the milestone payment received from Novartis during the quarter and the recognition of $166,667 in revenue related to the up-front payment received in November 2007 from Warner, both as discussed in Note 8 of the Consolidated Financial Statements.
 
ITEM 3. 
QUALITATIVE AND QUANTITATIVE DISCLOSURES ABOUT MARKET RISK

 There have been no material changes to our exposures to market risk since December 31, 2007.  
 
ITEM 4.
CONTROLS AND PROCEDURES

 In accordance with Exchange Act Rules 13a-15 and 15d-15, the Company's management carried out an evaluation with participation of the Company's Chief Executive Officer and Chief Financial Officer, its principal executive officer and principal financial officer, respectively, of the effectiveness of the Company's disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation, the Chief Executive Officer and Chief Financial Officer concluded as of the end of the period covered by this Form 10-Q that the Company's disclosure controls and procedures are effective. There were no changes in the Company's internal controls over financial reporting that occurred during the quarter covered by this report that have materially affected or are reasonably likely to materially affect the Company's internal controls over financial reporting.
 
PART II. OTHER INFORMATION
 
ITEM 1.
LEGAL PROCEEDINGS 

 There have been no material changes to the legal proceedings described in the Company’s Form 10-K filed with the Securities and Exchange Commission on March 12, 2008.
 
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ITEM 1A.
RISK FACTORS
 
 There have been no material changes to the risk factors described in the Company’s Form 10-K filed with the Securities and Exchange Commission on March 12, 2008.
 
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
 None.
 
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ITEM 6.  EXHIBITS
 
31.1
 
Chief Executive Officer’s Certificate, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2
 
Chief Financial Officer’s Certificate, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1
 
Chief Executive Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 – furnished only.
     
32.2
 
Chief Financial Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 – furnished only.
 
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SIGNATURES

In accordance with the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
NEXMED, INC.
   
Date: May 8, 2008
 
 
Vice President and Chief Financial
Officer
 
25


EXHIBIT INDEX
 
31.1
 
Chief Executive Officer’s Certificate, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2
 
Chief Financial Officer’s Certificate, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1
 
Chief Executive Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 – furnished only.
     
32.2
 
Chief Financial Officer’s Certificate, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 – furnished only.
 
26