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EX-31.1 - EXHIBIT 31.1 - ALPHARX INCexhibit31-1.htm
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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: December 31, 2010

OR

[_] Transition Report Pursuant To Section 13 or 15(d) of the Securities Exchange Act of 1934.
For the transition period from: to

Commission File Number: 000-030813

AlphaRx, Inc.
(Name of Small Business Issuer in its Charter)

Delaware 98-0416123
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)  

168 Konrad Crescent, Suite 200
Markham, Ontario, Canada L3R 9T9
(Address of principal executive offices)

Registrant's telephone number, including area code: (905) 479-3245

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 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 [   ]

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, 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 [X]

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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [   ] No [X]

The number of outstanding shares of registrant's Common Stock on February 14, 2011 was 94,635,047.


ALPHARX, INC.

FORM 10-Q


DECEMBER 31, 2010

TABLE OF CONTENTS

Part I:  Financial Information 
Item 1. Financial Statements.  
Unaudited Interim Consolidated Balance Sheets as of December 31 2010 and September 30, 2010 (Audited) 3
Unaudited Interim Consolidated Statements of Operations and Comprehensive Loss for the three months ended December 31, 2010 and December 31, 2009 4
Unaudited Interim Consolidated Statements of Changes in Shareholders’ Deficit as of December 31, 2010 and September 30, 2010 5
Unaudited Interim Consolidated Statements of Cash Flow for the three months ended December 31, 2010 and December 31, 2009 6
  Condensed Notes to Unaudited Interim Consolidated Financial Statements 7 - 11
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operation 12 - 16
Item 3. Quantitative and Qualitative Disclosures About Market Risk. 16
Item 4. Controls and Procedures. 16
Part II:  Other Information  
Item 1. Legal Proceedings. 17
Item 1A. Risk Factors. 17
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. 18
Item 3. Defaults Upon Senior Securities. 18
Item 4. (Removed and Reserved). 18
Item 5. Other Information. 18
Item 6. Exhibits. 18

2


PART I: FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS.

ALPHARx, INC.
INTERIM CONSOLIDATED BALANCE SHEETS
AS AT DECEMBER 31, 2010 AND SEPTEMBER 30, 2010
(All amounts in US Dollars)

    December 31,     September 30,  
    2010     2010  
    (UNAUDITED)     (AUDITED)  
             
CURRENT ASSETS            
             
   Cash and Cash Equivalents $  16,524   $  16,264  
   Accounts Receivable   93,287     147,839  
         TOTAL CURRENT ASSETS   109,811     164,103  
             
PROPERTY, PLANT and EQUIPMENT, net   33,359     43,078  
             
TOTAL ASSETS   143,170     207,181  
             
CURRENT LIABILITIES            
   Accounts Payable and Accrued Liabilities   602,888     520,342  
   Notes Payable (Note 3)   840,517     790,671  
   Deferred Revenue   -     0  
TOTAL CURRENT LIABILITIES   1,443,405     1,311,013  
             
             
STOCKHOLDERS’ DEFICIENCY            

Common Stock: $ 0.0001 par value, Authorized: 250,000,000 shares; Issued and outstanding December 31 and September 30, 2010- 94,635,047 (Notes 5-7)

  9,464     9,464  
             
   Additional paid-in capital   17,501,702     17,500,855  
   Deficit   (18,990,468 )   (18,789,891 )
   Accumulated Other Comprehensive Loss   (4,046 )   (2,284 )
   Non-controlling Interest   183,113     178,024  
TOTAL DEFICIENCY   (1,300,235 )   (1,103,832 )
             
TOTAL LIABILITIES AND DEFICIENCY $  143,170   $  207,181  

Signed: Michael Lee Signed: Dr. Ford Moore
Director Director

See condensed notes to unaudited consolidated financial statements

3


ALPHARx, INC.
INTERIM CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2010 AND 2009
(UNAUDITED)
(All amounts in US Dollars)

    December 31,  
    2010     2009  
             
             
Consulting Revenue $  -   $  -  
License Fees and Royalties   22,830     51,570  
TOTAL REVENUES   22,830     51,570  
             
General and Administrative Expenses   169,728     98,478  
Research and Development Expenses   13,646     45,391  
Depreciation   9,654     10,081  
LOSS FROM OPERATIONS   (170,198 )   (102,380 )
             
OTHER EXPENSES            
             
Interest Expense, net   (25,054 )   (19,835 )
             
LOSS BEFORE INCOME TAXES   (195,253 )   (122,215 )
             
     Income Tax   -     -  
             
NET LOSS   (195,253 )   (122,215 )
             
     Net Income/Loss attributable to Non-controlling interests   3,902     (303 )
             
NET LOSS ATTRIBUTABLE TO ALPHARX INC. STOCKHOLDERS   (191,351 )   (122,518 )
             
COMPREHENSIVE LOSS            
 Net Loss   (195,253 )   (122,215 )
 Translation Adjustment   (2,203 )   (4,136 )
 Comprehensive Loss   (197,456 )   (126,351 )
Less: Comprehensive Loss/Income attributable to Non-controlling interests   441     317  
COMPREHENSIVE LOSS ATTRIBUTABLE TO ALPHARX            
INC. STOCKHOLDERS $  (197,015 ) $  (126,034 )
             
             
Per Share Data            
Net Loss per Share, basic and diluted attributable to AlphaRx Inc. stockholders $ (0.002 ) $ (0.001 )
Weighted Average Number of Common Shares Outstanding   94,635,047     92,371,192  

See condensed notes to interim consolidated financial statements

4


ALPHARx, INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ DEFICIENCY
FOR THE PERIOD ENDED DECEMBER 31, 2010
(UNAUDITED)
(All amounts in US Dollars)

    Common Stock                                      
                                                 
                      Accumulated           Total AlphaRx              
                Additional      Other           Inc.          Non-        
    Number of           Paid in     Comprehensive           Stockholders’     controlling          Total  
    Shares     Amount     Capital     Loss     Deficiency     Deficiency      Interest     Deficiency  
                                               
                                                 

Balance as of September 30, 2009

  92,371,192   $ 9,238   $ 17,052,076     (2,317 )   (18,061,820 )   (1,002,823 )   102,240     (900,583 )

Warrants issued for services

          262,090             262,090         262,090  

Debt Conversion

          73,723             73,723         73,723  

Add’l pickup of Equity by NCI

                          99,514     99,514  

Stock issued for Service

  2,263,855     226     112,966             113,192         113,192  

Foreign Currency Translation

              33         33         33  

Non- controlling interest

                          (23,730 )   (23,730 )

Net Loss 2010

                          (728,071 )   (728,071 )         (728,071 )

Balance as of September 30, 2010

  94,635,047   $ 9,464   $ 17,500,855   $ (2,284 )   (18,789,891 ) $ (1,281,856 ) $ 178,024   $ (1,103,832 )

Foreign Currency Translation

              (1,762 )       (1,762 )   (441 )   (2,203 )

Non- controlling interest

                          (3,902 )   (3,902 )

Net Loss for the Period

                  (191,351 )   (191,351 )       (191,351 )

Transaction Adjustment

          847         (9226 )   (8,379 )   9,432     1,053  

Balance as of December 31, 2010

  94,635,047   $ 9,464   $ 17,501,702   $ (4,046 ) $ (18,990,468 ) $ (1,483,348 ) $ 183,113   $ (1,300,235 )

See condensed notes to interim consolidated financial statements

5


ALPHARx, INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2010 AND 2009
(UNAUDITED)
(All amounts in US Dollars)

Three months ended December 31,   2010     2009  
             
CASH FLOWS FROM OPERATING ACTIVITIES            
   Net Loss $  (195,253 ) $  (122,215 )
Adjustments to reconcile net loss to net cash used in operating activities:        
   Depreciation and amortization   9,654     10,081  
   Prior period adjustment   1,051        
   Changes in assets and liabilities:            
           Decrease (Increase) in accounts receivable   54,551     36,517  
           (Decrease) Increase in accounts payable and accrued liabilities   82,543     43,051  
           Accrued interest on notes payable   46,333     16,936  
           Increase (Decrease) in deferred revenue   -     (35,000 )
NET CASH USED IN OPERATING ACTIVITIES   (1,121 )   (50,630 )
CASH FLOWS FROM INVESTING ACTIVITIES            
             Purchase of Machinery & Equipment, net of disposals   65     (5,691 )
NET CASH PROVIDED BY INVESTING ACTIVITIES   65     (5,691 )
CASH FLOWS FROM FINANCING ACTIVITIES            
             Issuance (repayment) of Notes Payable, net   3,519     57,816  
NET CASH PROVIDED BY FINANCING ACTIVITIES   3,519     57,816  
Effect of exchange rate changes on cash and cash equivalents   (2,203 )   3,327  
NET INCREASE (DECREASE) IN CASH   260     4,822  
CASH, and cash equivalents, beginning of period   16,264     14,006  
CASH, and cash equivalents, end of period $  16,524   $  18,828  
             
             
SUPPLEMENTARY INFORMATION            
Taxes Paid $  0   $  0  
Interest Paid $  0   $  0  

See condensed notes to interim consolidated financial statements

6


ALPHARX INC.
CONDENSED NOTES TO UNADUDTED INTERIM
CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER 31, 2010
(UNAUDITED)

NOTE 1. NOTES TO INTERIM UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

The accompanying interim unaudited consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and do not include all the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of all recurring accruals) considered necessary for fair presentation have been included. Operating results for the interim periods are not necessarily indicative of the results that may be expected for the year ended September 30, 2010. Interim unaudited consolidated financial statements should be read in conjunction with the Company’s annual audited financial statements.

NOTE 2. NATURE OF BUSINESS AND GOING CONCERN

ALPHARx, INC. (the “Company”) was incorporated under the laws of the State of Delaware on August 7, 1997. The company is an emerging pharmaceutical company specializing in the formulation of human therapeutic products using proprietary drug delivery technologies.

The interim unaudited consolidated financial statements reflect the activities of AlphaRx Inc., 100% of AlphaRx Canada Limited and 80% of AlphaRx International Holdings Limited and AlphaRx Life Sciences Ltd. (AIH’s wholly owned subsidiary) collectively the “Company”. All material inter-company accounts and transactions have been eliminated.

The accompanying interim unaudited consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Accordingly, they do not include any adjustments relating to the realization of the carrying value of assets or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. Continuance of the Company as a going concern is dependent on its future profitability and on the on-going support of its shareholders, affiliates and creditors. Factors relating to going concern issues include working capital deficiencies, operating losses, shareholders’ deficits, and continued reliance on external funding sources. In order to mitigate the going concern issues, the Company is constantly pursuing new business arrangements and striving to achieve profitability, and seeking capital funding on an ongoing basis via the issuance of promissory notes, and private placements. The Company has contracted with several parties for research and development consulting services that could also result in future license fees and royalties. The Company has one licensee that provides an ongoing royalty stream for its Indaflex product. The Company is constantly seeking out collaborative arrangements with third parties in anticipation of license fees, royalties, milestone payments and consulting services.

NOTE 3. NOTES PAYABLE

The Company issued $3,519 in promissory notes (Net of Amount Repaid) during the three months ended December 31, 2010. These notes bear interest at 12% per annum and are repayable on the first anniversary date of issuance. Previously issued promissory notes bear interest at rates of 8% - 12% per annum. Prepayment of these notes prior to the first anniversary date is permitted.

See also note 8 – Related Party Transactions.

NOTE 4. NON-CONTROLLING INTEREST

Effective June 22, 2006, AlphaRx International Holdings Ltd. (“AIH”) issued 1,500 shares of its common stock to New Super Limited (“NSL”) at a price of approximately $HK 6,667 per share or $HK 10 million in cash (USD $1,288,826). There were 10,000 common shares outstanding of which 8,500 or 85% belong to the Company. With the consolidation of only 85% of AIH, a non-controlling interest was established, representing net amounts owing to the non-controlling shareholder. The capital infusion into AIH is accounted for as additional paid in capital on the interim consolidated financial statements of the Company.

7


On May 18, 2010, AlphaRx International Holdings Ltd. (“AIH”) issued 625 shares of its common stock to New Super Limited (“NSL”) at a price of approximately $HK 2,166 per share, or $HK1,353,750 in cash (USD$173,292), representing a further 5% non-controlling interest and increasing the total of the non-controlling interest to 20% after the infusion.

NOTE 5. COMMON STOCK

The Company is authorized to issue 250,000,000 shares of common stock. As of December 31, 2010 there were 94,635,047 shares of Common Stock issued and outstanding with a stated par value of $0.0001 per share.

NOTE 6. STOCK OPTION PLANS

The Company has one Stock Option Plan (the “2008 Stock Option Plan”) under which officers, key employees, certain independent contractors, and independent directors may be granted options to purchase shares of the Company’s authorized but unissued Common Stock. All outstanding options currently expire no later than June 30, 2012. Proceeds received by the Company from exercises of stock options are credited to Common Stock and additional paid-in capital.

At the Company’s Annual General Meeting held November 26, 2008 a majority of stockholders approved amendments to the existing Stock Option Plans including, among others: (i) combining the 2004 and 2006 Plans into the 2008 Stock Option Plan for ease of administration; (ii) providing a cap for the number of options to be issued at 22,000,000; (iii) providing guidelines for exercise prices such that the exercise price of any newly granted option is never less than the market value or in the case of a 10%+ holder, never less than 110% of the market value on the date of grant; (iv) providing for a maximum term of 5 years for any option granted; (v) provide for a vesting schedule whereby vesting must occur over at least 18 months with no more than 1/6th of the options granted vesting in any 3 month period; (vi) providing for the maximum number of options to be granted to any one individual in any 12 month period to be no more than 5% of the issued and outstanding common stock, and (vii) providing for a maximum number of options to be granted to any Investor Relations party to be no more than 2% of the issued and outstanding common stock.

As a result of the new terms governing the Company’s 2008 Stock Option Plan, the maximum number of options that can still be issued totals 4,310,000, regardless of whether existing options are exercised or cancelled.

During the three months ended December 31, 2010, no options were granted and no options were exercised. Additional details of the 2008 Plan, as at December 31, 2010 are as follows:

                                     
    Number Granted,                 Share              
    Exercised,                 Price on           Remaining  
2008 Stock   Expired or           Exercise     Grant     Expiry     Contractual  
Option Plan   Cancelled     Issue Date     Price $     Date $     Date     Life (Years)  
                                     

Inception

  0                                

Granted

  12,720,000     15/11/2004     0.15     0.11     6/30/2012     1.5  

Cancelled

  (6,000,000 )   12/28/2007     -     -     -     -  

Granted

  500,000     15/11/2004     0.40 – 0.50     0.11     -     -  

Cancelled

  (40,000 )   12/28/2007     -     -     -     -  

Expired

  (460,000 )   2/10/2008     -     -     -     -  

Granted

  7,000,000     10/1/2005     0.16     0.14     6/30/2012     1.5  

Granted

  390,000     8/2/2005     0.15     0.14     6/30/2012     1.5  

Cancelled

  (40,000 )   12/28/2007     -     -     -     -  

Granted

  100,000     5/25/2005     0.13     0.13     6/30/2012     1.5  

Granted

  3,290,000     10/17/2005     0.075     0.08     -     -  

Cancelled

  (560,000 )   12/28/2007     -     -     -     -  

Granted

  90,000     1/3/2007     0.10     0.10     1/3/2012     1  

Exercised

  (2,730,000 )   12/27/2007     0.075     -     -     -  

Remaining

  14,260,000     As at December 31, 2010

Weighted Average Exercise Price and Contractual Life of Options Remaining in Years

$

0.15                 1.4  

8


The Company has adopted the fair value accounting for employee stock options. The Company did not record any stock based compensation expense during the three months ended December 31, 2010. The Black-Scholes option-pricing model is used to calculate this expense. There are no further stock based compensation expenses to be recorded based on options granted to date and their existing terms and conditions. Multiplying the options by their exercise price and dividing the total obtained by the total outstanding options calculated the weighted average exercise price.

NOTE 7. WARRANTS

On April 12, 2010, the Company issued 3,740,150 warrants to purchase 3,740,150 shares of Common Stock at $0.085 per share, expiring on April 11, 2015. The warrants were issued in exchange for financial advisory services to be provided from the period from April 11, 2010 until September 30, 2010. The total fair value of the warrants has been estimated to be $262,090 using the Black-Scholes option pricing model based on the following assumptions: dividend yield of 0%, expected volatility of 103.86%, risk-free interest rate of 3%, and an expected life of 5 years. The company recorded $262,090 in stock based compensation for the year ended September 30, 2010. There were no warrants exercised nor issued during the three months ended December 31, 2010. The Company has the following warrants outstanding to purchase shares of Common Stock as of December 31, 2010:

Outstanding
as at
June
30, 2010
Issue
Date
Exercise
Price
$
Share
Price on
Grant Date
$
Expiry
Date
Remaining
Contractual
Life (Years)
Reason for
Issuance
3,000,000 4/1/2009 0.03 0.03 3/31/2014 3.25

Issued in exchange for financial advisory services.

3,740,150 4/12/2010 0.085 0.085 4/11/2015 4.28

Issued in exchange for financial advisory services.

Total Weighted
Average
Exercise
Price
Weighted
Average
Contractual
Life (Years)

6,740,150   0.06     3.765  

NOTE 8: RELATED PARTY TRANSACTIONS

The Company sources some of its funding in the form of promissory notes from Michael Lee – President and CEO. The Company is indebted to Mr. Lee in the amount of $62,236 including accrued interest of $13,975 as of December 31, 2010. The directors did not loan any funds to the Company during the three months ended December 31, 2010. These promissory notes bear interest at 12% per annum and are unsecured.

NOTE 9: RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS

In December 2007, the FASB updated FASB ASC Subtopic 810-10, Consolidation (formerly SFAS No. 160). This guidance establishes accounting and reporting standards for non-controlling interests in subsidiaries. The guidance clarifies that a non-controlling interest in a subsidiary be accounted for as a component of equity, but separate from the parent’s equity. Furthermore, the amount of consolidated net income attributable to the parent and the non-controlling interest must be clearly identified and presented on the face of the Consolidated Statements of Operations. The Company adopted the provisions of the guidance effective October 1, 2009 and the provisions are being applied prospectively, except for the presentation and disclosure requirements, which have been applied retrospectively. The adoption did not have a material impact on our consolidated financial statements.

9


Recent Issued Standards

FASB ASC Update No. 2009-05 - In August 2009, the FASB issued ASC Update No. 2009-05, Fair Value Measurements and Disclosures (Topic 820): Measuring Liabilities at Fair Value (“ASC Update No. 2009-05”). This update amends ASC 820, Fair Value Measurements and Disclosures and provides further guidance on measuring the fair value of a liability. The guidance establishes the types of valuation techniques to be used to value a liability when a quoted market price in an active market for the identical liability is not available, such as the use of an identical or similar liability when traded as an asset. The guidance also further clarifies that a quoted price in an active market for the identical liability at the measurement date and the quoted price for the identical liability when traded as an asset in an active market when no adjustments to the quoted price of the asset are required are both Level 1 fair value measurements. If adjustments are required to be applied to the quoted price, it results in a level 2 or 3 fair value measurement. The guidance provided in the update is effective for the first reporting period (including interim periods) beginning after issuance. The Company does not expect that the implementation of ASC Update No. 2009-05 will have a material effect on its financial position or results of operations.

FASB ASC Update No. 2009-12 - In September 2009, the FASB issued ASC Update No. 2009-12, Fair Value Measurements and Disclosures (Topic 820): Investments in Certain Entities that Calculate Net Asset Value per Share (or Its Equivalent) (“ASC Update No. 2009-12”). This update sets forth guidance on using the net asset value per share provided by an investee to estimate the fair value of an alternative investment. Specifically, the update permits a reporting entity to measure the fair value of this type of investment on the basis of the net asset value per share of the investment (or its equivalent) if all or substantially all of the underlying investments used in the calculation of the net asset value is consistent with ASC 820. The update also requires additional disclosures by each major category of investment, including, but not limited to, fair value of underlying investments in the major category, significant investment strategies, redemption restrictions, and unfunded commitments related to investments in the major category. The amendments in this update are effective for interim and annual periods ending after December 15, 2009 with early application permitted. The Company does not expect that the implementation of ASC Update No. 2009-12 will have a material effect on its financial position or results of operations.

In March 2010, the FASB issued new accounting guidance on embedded credit derivatives. This new accounting guidance clarifies the scope exception for embedded credit derivatives and defines which embedded credit derivatives should be evaluated for bifurcation and separate accounting. The Company does not expect that the implementation of this new accounting guidance will have a material effect on its financial position or results of operations.

FASB ASC Update No. 2010-22 - The FASB has issued FASB Accounting Standards Update (ASU) No. 2010-22, Accounting for Various Topics. ASU 2010-22 amends various SEC paragraphs in the FASB Accounting Standards CodificationTM (Codification) based on external comments received and the issuance of Staff Accounting Bulletin (SAB) No. 112 , which amends or rescinds portions of certain SAB topics. Specifically, SAB 112 was issued to bring existing SEC guidance into conformity with: Codification Topic 805, Business Combinations (originally issued as FASB Statement No. 141 (Revised December 2007), Business Combinations); and Codification Topic 810, Consolidation (originally issued as FASB Statement No. 160, Noncontrolling Interests in Consolidated Financial Statements).

FASB ASC Update No. 2010-29 - The FASB has issued ASU 2010-29, Business Combinations (Topic 805): Disclosure of Supplementary Pro Forma Information for Business Combinations. This amendment affects any public entity as defined by Topic 805, Business Combinations, that enters into business combinations that are material on an individual or aggregate basis. The comparative financial statements should present and disclose revenue and earnings of the combined entity as though the business combination(s) that occurred during the current year had occurred as of the beginning of the comparable prior annual reporting period only. The amendments also expand the supplemental pro forma disclosures to include a description of the nature and amount of material, nonrecurring pro forma adjustments directly attributable to the business combination included in the reported pro forma revenue and earnings. The amendments are effective prospectively for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2010. The adoption of the ASU 2010-29 will not have material impact to the financial statements of the Company.

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NOTE 10: PROPOSED RESTRUCTURING

On April 9, 2010 AlphaRx Canada Limited (“ACL”), a wholly-owned subsidiary of the Company signed a non-binding letter of intent with Pacific Orient Capital Inc. (“POC”), a Capital Pool Company listed on the Toronto Venture Exchange, whereby POC will effect a Qualifying Transaction (the “Transaction”), as such term is defined under the policies of the Toronto Venture Exchange (the “Exchange”), by acquiring all of the shares of ACL that are issued and outstanding at the time of closing of the transaction. The letter of intent was subsequently amended on June 9, 2010. The transaction is to be completed by a) the acquisition of ACL by way of a share exchange through the issuance of one common share of POC for every common share of ACL at a deemed price of CAD$0.40 per share; and b) the acquisition by AlphaRx International Holdings Ltd. (“AIH”), the Company’s 80% owned subsidiary, of an exclusive, royalty free licence from the Company, to commercialize the prescription drug Indaflex in Mexico and Asia for a period of 15 years; and c) the acquisition of a sub-licence by POC from AIH to commercialize the prescription drug Indaflex in Mexico and Asia for 8,250,000 Common shares of POC at a deemed price of CAD$0.40 per share. The transaction, among other conditions, shall be conditional upon the completion of a concurrent public offering or private placement of CAD $1.5 million of shares of common stock at a value of no less than CAD $0.60 per share. In relation thereto the Company has received a non-refundable deposit during April, 2010 of CAD $25,000 to assist in the restructuring. Completion of the proposed Transaction is conditional on the execution of a definitive agreement to be negotiated by the parties, acceptance and approval by the Exchange and the satisfaction of the minimum listing requirements of the Exchange. As of August 19, 2010 (review completion date), the Company has not yet received approval and acceptance by the Exchange and as a result, the interim consolidated financial statements do not purport to give effect to any adjustments that will be required should the Transaction be accepted and completed.

NOTE 11. TRANSACTION ADJUSTMENTS

Additional accumulated differences derived from the beginning balances of Non-controlling Interest and Additional-paid-in capital carryover from previous periods is adjusted to reflect the correct balancing figures. This adjustment is a change of accounting estimation on applicable foreign exchange rate on various transactions and its carryover effects. This change of estimation is not material and has no impact on current period statement of income or operation results.

NOTE 12. RECLASSIFICATIONS

Certain amounts from prior year have been reclassified to conform to current year’s presentation.

NOTE 13. SUBSEQUENT EVENTS

Management has reviewed subsequent events through the date of filing the Quarter Report on Form 10-Q that includes these interim consolidated financial statements with the US Securities and Exchange Commission. There were no material subsequent events as at February 14, 2011 that would require recognition or note disclosure in these financial statements.

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ITEM 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

The following discussion should be read in conjunction with the information contained in the consolidated financial statements of the Company and the notes thereto appearing elsewhere herein and in conjunction with the Management's Discussion and Analysis of Financial Condition and Results of Operations set forth in the Company's Annual Report on Form 10-K for the year ended September 30, 2010. Readers should carefully review the risk factors disclosed in this Form 10-K and other documents filed by the Company with the SEC.

As used in this report, the terms "Company", "we", "our" and "us" refer to AlphaRx, Inc., a Delaware corporation.

PRELIMINARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Report contains forward-looking statements within the meaning of the federal securities laws. These include statements about our expectations, beliefs, intentions or strategies for the future, which we indicate by words or phrases such as "anticipate," "expect," "intend," "plan," "will," "we believe," "management believes" and similar language. The forward-looking statements are based on the current expectations of the Company and are subject to certain risks, uncertainties and assumptions, including those set forth in the discussion under "Management's Discussion and Analysis of Financial Condition and Results of Operations" in this report. Actual results may differ materially from results anticipated in these forward-looking statements. We base the forward-looking statements on information currently available to us, and we assume no obligation to update them.

Investors are also advised to refer to the information in our previous filings with the Securities and Exchange Commission (SEC), especially on Forms 10-K, 10-Q and 8-K, in which we discuss in more detail various important factors that could cause actual results to differ from expected or historic results. It is not possible to foresee or identify all such factors. As such, investors should not consider any list of such factors to be an exhaustive statement of all risks and uncertainties or potentially inaccurate assumptions.

General

AlphaRx is a specialty pharmaceutical company dedicated to developing proven therapies by reformulating FDA approved and marketed drugs which through the application of its proprietary site-specific nano drug delivery technology, offers improved medical benefits and a potential for significant commercial product development. Our core competence is in the development of novel drug formulations for therapeutic molecules or compounds that have exhibited poor gastro intestinal absorption due to poor solubility or have yet be administrable to the human body with an acceptable delivery method. Our nano drug delivery system is versatile and offers significant flexibility in the development of suitable dosage formulations (i.e. oral, topical or parenteral) to meet the requirements of specific drug molecules.

Since 2000, substantial efforts and resources have been devoted to understanding our nano drug delivery technology and establishing a product development pipeline that incorporated this technology with selected molecules. Since 2008, AlphaRx has undergone many positive changes. New corporate initiatives for China and a corresponding strategic growth plan were implemented; our corporate strategy was refocused on commercializing our nano drug delivery technology as quickly as possible, building high-value partnerships and reprioritizing the product pipeline. Spending was redirected and aggressive cost control initiatives were implemented. We continue to investing in the further development of our nano drug delivery technology and to actively seek collaborators and licensees to accelerate the development and commercialization of products incorporating our nano drug delivery system in exchange for milestone payments and royalties. Further development, exploration and commercialization of the technology entail risk and operational expenses. However, we have made significant progress on refocusing our efforts on strategic development initiatives and cost control and continue to aggressively seek to reduce non-strategic spending.

Although our product development program address various pharmaceutical markets, including inflammation, stroke and pneumonia, we constantly evaluate and reassess our development program, resulting in new product candidates and discontinuing or delaying lower priority development program. This development optimization process is essential for assembling a portfolio of short and long-term drug candidates, in order to build a stable and sustainable revenue and profits for our Company.

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Recent Developments

On April 9, 2010, we entered into a non-binding letter of intent with Pacific Orient Capital Inc. (“Pacific”), a Capital Pool Company listed on the TSX Venture Exchange, concerning the proposed acquisition of AlphaRx Canada Limited ("ACL"), a wholly owned subsidiary of the Company. The letter of intent was subsequently amended on June 9, 2010. The proposed acquisition, if completed, will constitute Pacific's qualifying transaction pursuant to the policies of the TSX Venture Exchange Inc. (the "Exchange").

The qualifying transaction is to be completed by (a) the acquisition of ACL by way of share exchange through the issuance of one common share of Pacific for every one common share of ACL at a deemed price of C$0.40 per share; and (b) the acquisition by Pacific of a licence from AIH to commercialize the prescription drug Indaflex in Mexico and Asia for 8,250,000 common shares of Pacific at a deemed price of C$0.40 per share (the "Transaction"). Pacific has advanced $25,000 to the Company on a non-refundable basis. Completion of the proposed Transaction is conditional on the execution of a definitive agreement to be negotiated among the parties, the satisfactory completion of due diligence, Exchange acceptance and the satisfaction of the minimum listing requirements of the Exchange.

On June 28, 2010, we terminated our licensing agreement with Cypress Biosciences (“Cypress”), our world-wide (except Mexico and Asia) development partner for Indaflex. Despite the termination of Indaflex development program with Cypress, we continue to develop Indaflex for the Chinese market. We are currently working with our regulatory consultants, pending availability of stability data, in preparation for submission of a clinical trial application with the China State Food and Drug Association (“SFDA”) in order to begin human trials in China. These preparations are proceeding on schedule.

Our other product candidates in development are in earlier or preclinical research phases, and we continue to assess them for their compatibility with our technology and market need. Our intent is to seek partnerships with pharmaceutical and biotechnology companies for certain of these products. We plan to expand our pipeline with product candidates that demonstrate significant opportunities for growth.

Overview of Results of Operations

                                                 

Three

  Dec 31     Sep 30     June 30     Mar 31     Dec 31     Sep 30     June 30     Mar 31  

Months

  2010     2010     2010     2010     2009     2009     2009     2009  

Ended

  $      $      $      $      $      $      $      $   
                                                 

Net Sales

  22,830     180,432     45,623     48,720     51,570     88,815     20,982     164,109  

Net Income
(Loss)

  (191,351 )   (242,109 )   (157,366 )   (206,078 )   (122,518 )   (208,562 )   (235,695 )   23,420  

Net Income
(Loss) per
Share (1)

  (0.01 )   (0.01 )   (0.01 )   (0.01 )   (0.01 )   (0.01 )   (0.01 )   0.00  

NOTE (1) Net Loss per share on a quarterly basis does not equal net Loss per share for the annual periods due to rounding.

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RESULTS OF OPERATIONS FOR THE THREE MONTHS ENDED DECEMBER 31, 2010, AS COMPARED TO THE THREE MONTHS ENDED DECEMBER 31, 2009

The Company incurred a net loss of $191,351 for the three month period ended December 31, 2010 as compared to a net loss of $122,518 incurred for the same period a year ago, an increase of $68,833. Revenues during the three months ended December 31, 2010 were about $28,740 less than in the previous period and general and administrative expenses were about $71,250 more than in previous period. These two items were the primary cause for the increase in net loss between periods.

Revenues

Total revenues for the three-month period ended December 31, 2010 were $22,830 as compared to $51,570 generated for the same period a year ago, a decrease of $28,740 or about 56%. Royalty revenues were comparable year over year at $22,830 for the three months ended December 31, 2010 as compared to $51,570 for the same period a year ago, a decrease of $28,740 or about 56%. We continue to pursue revenue opportunities in all forms (consulting, royalties and license fees).

General and Administrative Expenses

General and Administrative expenses consist primarily of personnel costs related to general management functions, finance, office overheads, as well as insurance costs and professional fees related to legal, audit and tax matters.

General and Administrative expenses were $169,728 for the three month period ended December 31, 2010 as compared to $98,478 incurred for the same period a year ago, an increase of $71,250 or about 72%. The increase is primarily due to transaction costs associated with the proposed merger between AlphaRx Canada Limited and Pacific Orient Capital Inc.

Research and Development Expenses

Research and development expenses include costs for scientific personnel, supplies, equipment, and outsourced clinical and other research activities.

Research and development expenses for the three months ended December 31, 2010 were $13,646 as compared to $45,391 incurred for the same period a year ago, a decrease of $31,745 or about 70%. The continuing strength of the Canadian dollar continues keep out US Dollar costs high when translated. Research efforts will again increase in the future depending on the timing and availability of additional funds. We also seek collaborative partners in order to obtain third party funding for certain drug candidates that show commercial promise in exchange for commercialization rights.

Depreciation

Depreciation totalled $9,654 for the three months ended December 31, 2010 as compared to $10,081 incurred during the same period a year ago, a decrease of $427 or about 4.2%. Our capital asset purchases were minimized during the last fiscal year. Certain assets are now fully depreciated resulting in decreasing depreciation expense. Should any assets become permanently impaired they are written off to income as determined.

Loss from Operations

Loss from operations were $170,198 for the three months ended December 31, 2010 as compared to a net loss of $102,380 incurred for the same period a year ago, an increase of $67,818 or about 66%.

Interest Expense

Interest expense for the three months ended December 31, 2010 was $25,054 as compared to interest expense of $19,835 generated during the same period a year ago owing to the principle amount of loan is increasing.

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Non-Controlling interest in gain/(loss) of Consolidated Subsidiaries

We reflected a non-controlling interest income of $3,902 for the three months ended December 31, 2010 as compared to a non-controlling interest loss of $303 for the same period a year ago. Non-Controlling interest represents our minority shareholder’s proportionate interest (which is 20%) in our 80% owned subsidiary – AIH. The non-controlling interest resulted in the investment in our subsidiary AlphaRx International Holdings Ltd. by an independent third party – New Super Ltd. during June 2006. On 5/18/2010, New Super Ltd. had infused an additional $173,237 in exchange of an additional 5% ownership of our subsidiary AlphaRx International Holdings Ltd.

Net Loss

As a result of the above mentioned revenue and expense items, we incurred a net loss of $191,351 for the three months ended December 31, 2010 as compared to a net loss of $122,518 generated in the same period a year ago.

LIQUIDITY AND CAPITAL RESOURCES

As at December 31, 2010 the Company had a working capital deficiency of $1,333,594 as compared to a working capital deficiency of $1,146,910 as at September 30, 2010. The Company has also increased its stockholders’ deficiency to $1,300,235 as at December 31, 2010 compared to a stockholders’ deficiency of $1,103,832 as at September 30, 2010. We did not issue any stock during the three months ended December 31, 2010.

We have a licensing arrangement with Andromaco, which provides us with a small royalty stream. We also have licensing arrangements with Gaia BioPharma Limited which may provide us with milestone payments and/or royalty streams in the future. There is no assurance that such payments or royalty streams will materialize.

Since inception, we have financed operations principally from the sale of Common Stock and issuance of promissory notes and expect to continue this practice to fund our ongoing activities.

We currently do not have sufficient resources to complete the commercialization of any of our proposed products or to carry out our entire business strategy. Therefore, we will likely need to raise substantial additional capital to fund our operations in the future. We cannot be certain that any financing will be available when needed on acceptable terms or at all. Any additional equity financings will be dilutive to our existing stockholders, and debt financing, if available, may require additional stock to be issued and/or involve restrictive covenants on our business.

We expect to continue to spend capital on:

1. research and development programs;
2. preclinical studies and clinical trials;
3. regulatory processes; and
4. third party licensees and distribution partners to manufacture and market our products for us.

The amount of capital we may need will depend on many factors, including:

1. the progress, timing and scope of our research and development programs;
2. the progress, timing and scope of our preclinical studies and clinical trials;
3. the time and cost necessary to obtain regulatory approvals;
4. the time and cost necessary to establish or to retain sales and marketing partners to market our products;
5. the time and cost necessary to respond to technological and market developments; and
6. new collaborative, licensing and other commercial relationships that we may establish.

The inability to raise capital would have a material adverse effect on the Company. We currently have no capital commitments other than one leased auto and for certain research equipment.

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CERTAIN FACTORS THAT MAY AFFECT FUTURE RESULTS

Certain of the information contained in this document constitutes “forward-looking statements”, including but not limited to those with respect to the future revenues, our development strategy, involve known and unknown risks, uncertainties, and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the risks and uncertainties associated with a drug delivery company which has not successfully commercialized our first product, including a history of net losses, unproven technology, lack of manufacturing experience, current and potential competitors with significant technical and marketing resources, need for future capital and dependence on collaborative partners and on key personnel. Additionally, we are subject to the risks and uncertainties associated with all drug delivery companies, including compliance with government regulations and the possibility of patent infringement litigation, as well as those factors disclosed in our documents filed from time to time with the United States Securities and Exchange Commission.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Not required for smaller reporting companies.

ITEM 4. CONTROLS AND PROCEDURES

Management assessed our internal control over financial reporting as of December 31, 2010. Management based its assessment on criteria established in Internal Control – Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Management’s assessment included an evaluation of the design of our internal control over financial reporting and testing of the operational effectiveness of those controls.

Based on this assessment, management has concluded that as of December 31, 2010, our internal control over financial reporting was ineffective to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles. We noted that there is a lack of segregation of certain duties at the Company due to the small number of employees with responsibility for general administrative and financial matters. This constitutes a deficiency in financial reporting. We therefore conclude that our disclosure controls over financial reporting were ineffective as of and for the three months ended December 31, 2010. At this time, management has decided that considering the employees involved and the control procedures in place, the risks associated with such lack of segregation of duties are insignificant and the potential benefits of adding additional employees to clearly segregate duties do not justify the additional expenses associated with such increases. Management will periodically re-evaluate this situation. If the volume of business increases and sufficient capital is secured, it is the Company’s intention to further increase staffing to mitigate the current lack of segregation of duties within the general, administrative and financial functions.

Changes in Internal Controls

Management has evaluated the effectiveness of the disclosure controls and procedures as of December 31, 2010. Based on such evaluation, management has concluded that the disclosure controls and procedures were ineffective for their intended purpose described above. There were no changes to the internal controls during the quarter ended December 31, 2010 that have materially affected or that are reasonably likely to affect the internal controls.

Limitation on the Effectiveness of Controls

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Such limitations include the fact that human judgment in decision-making can be faulty and that breakdowns in internal control can occur because of human failures, such as simple errors or mistakes or intentional circumvention of the established process.

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PART II: OTHER INFORMATION

ITEM 1 - LEGAL PROCEEDINGS

There are currently no legal proceedings against the Company or any of its subsidiaries.

ITEM 1A – RISK FACTORS

The following risk factors should be read carefully in connection with evaluating our business and the forward-looking statements that we make in this Report and elsewhere (including oral statements) from time to time. Any of the following risks could materially and adversely affect our business, our operating results, our financial condition and the actual outcome of matters as to which forward-looking statements are made in this Report.

Financial Risks

  • We have a history of operating losses and we may never achieve profitability. If we continue to incur losses or we fail to raise additional capital or receive substantial cash inflows from our major shareholders, we may be forced to cease operations.

  • We may not be able to make the payments we owe to our creditor.

  • The audit opinion issued by our independent registered public accounting firm relating to our financial statements for the year ended September 30, 2010 contained a going concern explanatory paragraph.

Risks Related to our Business

  • We are highly dependent on the clinical success of our product candidates.

  • We are highly dependent upon collaborative partners to develop and commercialize compounds using our delivery agents.

  • Our collaborative partners control the clinical development of certain of our drug candidates and may terminate their efforts at will.

  • Our product candidates are in various stages of development, and we cannot be certain that any will be suitable for commercial purposes.

  • Our collaborative partners are free to develop competing products.

  • Our business will suffer if we cannot adequately protect our patent and proprietary rights.

  • We may be at risk of having to obtain a license from third parties making proprietary improvements to our technology.

  • We are dependent on third parties to manufacture and, in some cases, test our products.

  • We are dependent on our key personnel and if we cannot recruit and retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed.

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Risks Related to our Industry

  • Our future business success depends heavily upon regulatory approvals, which can be difficult to obtain for a variety of reasons, including cost.

  • We may face product liability claims related to participation in clinical trials for future products.

  • We are subject to environmental, health and safety laws and regulations for which we incur costs to comply.

  • We face rapid technological change and intense competition.

Other Risks

  • Our disclosure controls & procedures and internal control over financial reporting were ineffective. In connection with management’s assessment of the Company’s disclosure controls & procedures and internal control over financial reporting, we identified the following material weakness in our disclosure controls & procedures and internal control over financial reporting as of December 31, 2010:

Segregation of Duties: We did not maintain adequate segregation of duties related to job responsibilities for initiating, authorizing, and recording of certain transactions. Due to this material weakness, there is a risk that a material misstatement in the financial statements would not be prevented or detected on a timely basis. A deficiency in disclosure and internal controls may result in a loss of public confidence in the Company, which could have an adverse effect on our stock price.

ITEM 2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS.

We did not issue nor sell any equity securities during the three months ended December 31, 2010.

ITEM 3 - DEFAULTS UPON SENIOR SECURITIES

Not Applicable

ITEM 4 - (REMOVED AND RESERVED)

ITEM 5 - OTHER INFORMATION

Not Applicable

ITEM 6 - EXHIBITS

(i)   EXHIBITS.
     
31.1   Certification of Chief Executive and Interim Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a) under the Securities Exchange Act of 1934, as amended.
     
32.1   Certification of Chief Executive Officer and Interim Chief Financial Officer required by Rule 13a- 14(b) or Rule 15d-14(b) under the Securities Exchange Act of 1934, as amended, and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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SIGNATURES:

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

DATED: February14, 2011

  ALPHARx INC.
   
  By: /S/ Michael M. Lee
  Michael M. Lee, Chief Executive Officer
   
  Directors:
   
  By: /S/ Michael M. Lee
  Michael M. Lee, Director
   
  By: /S/ David Milroy
  Dr. David Milroy, Director
   
  By: /S/ Ford Moore
  Dr. Ford Moore, Director
 

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