NUTRA PHARMA CORP - Quarter Report: 2009 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
|
For the
quarterly period ended September 30, 2009
o
|
TRANSITION
REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE
ACT
|
For the
transition period from _________ to ________
Commission
file numbers 000-32141
NUTRA
PHARMA CORP.
(Name of
registrant as specified in its charter)
California
|
91-2021600
|
(State
or Other Jurisdiction of Organization)
|
(IRS
Employer Identification
Number)
|
1537
NW 65th Avenue,
Plantation, FL 33313
(Address
of principal executive offices)
(954)
509-0911
(Issuer's
telephone number)
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 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.
Large
accelerated filer o
|
Accelerated
filer o
|
Non-accelerated
filer o
|
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 o No x
The
number of shares outstanding of the registrant's common stock, par value $0.001
per share, as of November 6, 2009 was 269,200,232.
TABLE OF
CONTENTS
PART
I. FINANCIAL INFORMATION
|
|
|
|
Item
1. Financial Statements
|
3
|
|
|
Consolidated
Balance Sheets as of September 30, 2009 (Unaudited) and December 31,
2008
|
3
|
|
|
Consolidated
Statements of Operations for the three and nine months ended September 30,
2008 and 2009 (Unaudited) and for the period from inception (February 1,
2000) to September 30, 2009 (Unaudited)
|
4
|
|
|
Consolidated
Statements of Cash Flows for the nine months ended September 30, 2008 and
2009 (Unaudited) and for the period from inception (February 1, 2000) to
September 30, 2009 (Unaudited)
|
5
|
|
|
Notes
to Unaudited Consolidated Financial Statements
|
6
|
|
|
Item
2. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
|
10
|
|
|
Item
3. Quantitative and Qualitative Disclosures about Market
Risk
|
16
|
|
|
Item
4. Controls and Procedures
|
17
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PART
II. OTHER INFORMATION
|
|
|
|
Item
1. Legal Proceedings
|
17
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Item
1A. Risk Factors
|
18
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|
|
Item
2. Unregistered Sales of Equity Securities and Use of
Proceeds
|
18
|
Item
3. Defaults Upon Senior Securities
|
18
|
Item
4. Submission of Matters to a Vote of Security Holders
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18
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|
|
Item
5. Other Information
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18
|
|
|
Item
6. Exhibits
|
19
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|
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SIGNATURES
|
19
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2
Part
I. Financial
Information
Item
1. Financial Statements
NUTRA
PHARMA CORP.
(A
Development Stage Company)
Consolidated
Balance Sheets
December
31,
|
September
30,
|
|||||||
2008
|
2009
|
|||||||
(Unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
|
$ | 50,910 | $ | 1,996,454 | ||||
Inventory
|
10,770 | 66,860 | ||||||
Prepaid
expenses
|
27,468 | 11,946 | ||||||
Total
current assets
|
89,148 | 2,075,260 | ||||||
Property
and equipment, net
|
9,941 | 7,673 | ||||||
Other
assets
|
8,133 | 8,803 | ||||||
TOTAL
ASSETS
|
$ | 107,222 | $ | 2,091,736 | ||||
LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 156,399 | $ | 124,333 | ||||
Accrued
expenses
|
849,856 | 1,025,557 | ||||||
Due
to officers
|
1,557,301 | 1,536,031 | ||||||
Other
loans payable
|
100,000 | 80,000 | ||||||
Total
current liabilities
|
2,663,556 | 2,765,921 | ||||||
Stockholders'
deficit:
|
||||||||
Common
stock, $0.001 par value, 2,000,000,000 shares authorized;
|
||||||||
211,276,482
and 269,200,232 shares issued and outstanding,
respectively
|
211,277 | 269,201 | ||||||
Additional
paid-in capital
|
21,503,591 | 24,915,942 | ||||||
(Deficit)
accumulated during the development stage
|
(24,271,202 | ) | (25,859,328 | ) | ||||
Total
stockholders' deficit
|
(2,556,334 | ) | (674,185 | ) | ||||
TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
|
$ | 107,222 | $ | 2,091,736 |
See the
accompanying notes to the financial statements.
3
NUTRA
PHARMA CORP.
(A
Development Stage Company)
Consolidated
Statements of Operations
(Unaudited)
For
the
|
||||||||||||||||||||
Period
From
|
||||||||||||||||||||
February
1,
|
||||||||||||||||||||
2000
|
||||||||||||||||||||
(Inception)
|
||||||||||||||||||||
Through
|
||||||||||||||||||||
Three Months Ended September
30,
|
Nine Months Ended September
30,
|
September
30,
|
||||||||||||||||||
2008
|
2009
|
2008
|
2009
|
2009
|
||||||||||||||||
Sales
|
$ | 3,045 | $ | 900 | $ | 3,045 | $ | 27,528 | $ | 51,773 | ||||||||||
Cost
of sales
|
655 | - | 655 | 3,260 | 7,789 | |||||||||||||||
Gross
profit
|
2,390 | 900 | 2,390 | 24,268 | 43,984 | |||||||||||||||
Costs
and expenses:
|
||||||||||||||||||||
General
and administrative
|
431,321 | 448,391 | 950,838 | 1,020,196 | 9,173,381 | |||||||||||||||
Research
and development
|
- | 91,580 | - | 126,955 | 1,867,192 | |||||||||||||||
General
and administrative - stock based compensation
|
75,000 | 195,000 | 500,000 | 410,000 | 7,839,657 | |||||||||||||||
Write-off
of advances to potential acquiree
|
- | - | - | - | 629,000 | |||||||||||||||
Finance
costs
|
- | - | - | - | 786,000 | |||||||||||||||
Interest
expense
|
12,649 | 20,957 | 42,640 | 55,243 | 508,857 | |||||||||||||||
Amortization
of license agreement
|
- | - | - | - | 155,210 | |||||||||||||||
Amortization
of intangibles
|
- | - | - | - | 656,732 | |||||||||||||||
Losses
on settlements
|
- | - | - | - | 1,261,284 | |||||||||||||||
Write-down
of investment in subsidiary
|
- | - | - | - | 620,805 | |||||||||||||||
Equity
in loss of unconsolidated subsidiary
|
- | - | - | - | 853,540 | |||||||||||||||
Write-off
of investment in Portage BioMed
|
- | - | - | - | 60,000 | |||||||||||||||
Write-off
of investment in Xenacare
|
- | - | - | - | 175,000 | |||||||||||||||
Net
gain from deconsolidation of Receptopharm
|
- | - | - | - | (1,081,095 | ) | ||||||||||||||
Write-off
of goodwill
|
- | - | - | - | 2,397,749 | |||||||||||||||
Total
costs and expenses
|
518,970 | 755,928 | 1,493,478 | 1,612,394 | 25,903,312 | |||||||||||||||
Net
loss
|
$ | (516,580 | ) | $ | (755,028 | ) | $ | (1,491,088 | ) | $ | (1,588,126 | ) | $ | (25,859,328 | ) | |||||
Per
share information - basic and diluted:
|
||||||||||||||||||||
Loss
per common share
|
$ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||||||
Weighted
average common shares outstanding
|
188,838,473 | 224,710,545 | 153,588,517 | 217,217,631 |
See the
accompanying notes to the financial statements.
4
NUTRA
PHARMA CORP.
(A
Development Stage Company)
Consolidated
Statements of Cash Flows
(Unaudited)
For
the
|
||||||||||||
Period
From
|
||||||||||||
February
1,
|
||||||||||||
2000
|
||||||||||||
(Inception)
|
||||||||||||
Through
|
||||||||||||
Nine months ended September
30,
|
September
30,
|
|||||||||||
2008
|
2009
|
2009
|
||||||||||
Net
cash (used in) operating activities
|
$ | (854,461 | ) | $ | (1,115,011 | ) | $ | (7,779,217 | ) | |||
Cash
flows from investing activities:
|
||||||||||||
Cash
reduction due to deconsolidation of Infectech
|
- | - | (2,997 | ) | ||||||||
Cash
reduction due to deconsolidation of Receptopharm
|
- | - | (1,754 | ) | ||||||||
Cash
acquired in acquisition of Infectech
|
- | - | 3,004 | |||||||||
Cash
acquired in acquisition of Receptopharm
|
40,444 | - | 40,444 | |||||||||
Acquisition
of property and equipment
|
- | - | (96,029 | ) | ||||||||
Loan
to Receptopharm
|
(300,000 | ) | - | (300,000 | ) | |||||||
Investments
carried at cost
|
- | - | (235,000 | ) | ||||||||
Net
cash (used in) investing activities
|
(259,556 | ) | - | (592,332 | ) | |||||||
Cash
flows from financing activities:
|
||||||||||||
Common
stock issued for cash
|
808,500 | 3,060,275 | 6,668,275 | |||||||||
Proceeds
from convertible loans
|
- | - | 304,750 | |||||||||
Proceeds
from notes payable
|
- | 40,000 | 140,000 | |||||||||
Repayment
of notes payable
|
(80,000 | ) | (80,000 | ) | ||||||||
Repayment
of stockholder loans
|
- | (506,250 | ) | (615,000 | ) | |||||||
Loans
from stockholders
|
231,000 | 546,530 | 3,949,978 | |||||||||
Net
cash provided by financing activities
|
1,039,500 | 3,060,555 | 10,368,003 | |||||||||
Net
increase (decrease) in cash
|
(74,517 | ) | 1,945,544 | 1,996,454 | ||||||||
Cash
- beginning of period
|
122,810 | 50,910 | - | |||||||||
Cash
- end of period
|
$ | 48,293 | $ | 1,996,454 | $ | 1,996,454 | ||||||
Supplemental
Cash Flow Information:
|
||||||||||||
Cash
paid for interest
|
$ | - | $ | - | $ | - | ||||||
Cash
paid for income taxes
|
$ | - | $ | - | $ | - | ||||||
Non-cash
investing and financing activities:
|
||||||||||||
Assumption
of obligation under license agreement
|
$ | - | $ | - | $ | 1,750,000 | ||||||
Value
of shares issued as consideration in acquisition of Nutra Pharma,
Inc.
|
$ | - | $ | - | $ | 112,500 | ||||||
Payments
of license fee obligation by stockholder
|
$ | - | $ | - | $ | 208,550 | ||||||
Conversion
of stockholder loan to common stock
|
$ | - | $ | - | $ | 862,012 | ||||||
Loan
advances to Bio Therapeutics, Inc. by stockholder
|
$ | - | $ | - | $ | 629,000 | ||||||
Value
of common stock issued as consideration in acquisition of Infectech,
Inc.
|
$ | - | $ | - | $ | 4,486,375 | ||||||
Liabilities
assumed in acquisition of Infectech, Inc.
|
$ | 115,586 | ||||||||||
Cancellation
of common stock
|
$ | - | $ | - | $ | 14,806 | ||||||
Value
of common stock issued by stockholder to third party in connection with
settlement
|
$ | - | $ | - | $ | 229,500 | ||||||
Value
of common stock issued by stockholder to employee for services
rendered
|
$ | - | $ | - | $ | 75,000 | ||||||
Net
deferred taxes recorded in connection with acquisition
|
$ | - | $ | - | $ | 967,586 | ||||||
Notes
payable settled with common stock
|
$ | - | $ | - | $ | 98,000 | ||||||
Settlement
of stockholder loan in exchange for common stock of
subsidiary
|
$ | - | $ | - | $ | 1,384,931 | ||||||
Settment
of debt with common stock
|
$ | 1,200,000 | $ | - | $ | 1,406,750 | ||||||
Expenses
paid by stockhoder
|
$ | - | $ | - | $ | 119,140 | ||||||
Value
of common stock issued for the acquisition of Receptopharm
|
$ | - | $ | - | $ | 1,050,000 |
See the
accompanying notes to the financial statements.
5
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
September
30, 2009
1. BASIS
OF PRESENTATION
The
accompanying unaudited financial statements have been prepared in accordance
with generally accepted accounting principles (GAAP) for interim financial
information and Rule 8.03 of Regulation SX. They do not include all of the
information and footnotes required by GAAP for complete financial statements. In
the opinion of management, all adjustments (consisting only of normal recurring
adjustments) considered necessary for a fair presentation have been included.
The results of operations for the periods presented are not necessarily
indicative of the results to be expected for the full year. For further
information, refer to the financial statements of the Company as of
December 31, 2008 and 2007, and for the years then ended, including notes
thereto included in the Company’s Form 10-K.
The
accompanying financial statements are prepared in accordance with accounting
principles generally accepted in the United States of America, which require
management to make estimates and assumptions. These estimates and assumptions
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenue and expense. Actual results may differ from
these estimates.
In
preparing the accompanying financial statements, we have evaluated subsequent
events through November 18, 2009, the issuance date of this Quarterly Report on
Form 10-Q.
Principles
of Consolidation
The
consolidated financial statements presented herein include the accounts of Nutra
Pharma and its subsidiaries, Designer Diagnostics Inc. and ReceptoPharm Inc.
(collectively, the “Company”). All intercompany balances and transactions have
been eliminated in consolidation.
Income
(Loss) per Share
The
Company calculates net income (loss) per share as required by Statement of
Financial Accounting Standards (SFAS) 128, “Earnings per Share.” Basic
earnings (loss) per share, is calculated by dividing net income
(loss) by the weighted average number of common shares outstanding for the
period. Diluted earnings (loss) per share, is calculated by dividing net income
(loss) by the weighted average number of common shares and dilutive common
stock equivalents outstanding. During periods in which the Company incurs
losses, common stock equivalents, if any, are not considered, as their effect
would be anti dilutive.
Use of
Estimates
The
accompanying financial statements are prepared in accordance with accounting
principles generally accepted in the United States of America which require
management to make estimates and assumptions. These estimates and assumptions
affect the reported amounts of assets and liabilities and disclosure of
contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenue and expense. Actual results may differ from
these estimates.
2. BASIS
OF REPORTING
The
Company’s financial statements are presented on a going concern basis, which
contemplates the realization of assets and satisfaction of liabilities in the
normal course of business. At September 30, 2009, the Company had negative
working capital of $690,661 and an accumulated deficit of $25,859,328. In
addition, the Company has no significant revenue generating
operations.
The
Company’s ability to continue as a going concern is contingent upon its ability
to secure additional financing, increase ownership equity, and attain profitable
operations. In addition, the Company’s ability to continue as a going concern
must be considered in light of the problems, expenses and complications
frequently encountered in established markets and the competitive environment in
which the Company operates.
The
Company is pursuing financing for its operations and seeking additional
investments. In addition, the Company is seeking to establish a revenue base.
Failure to secure such financing or to raise additional equity capital and to
establish a revenue base may result in the Company depleting its available funds
and not being able to pay its obligations.
6
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
September
30, 2009
The
financial statements do not include any adjustments to reflect the possible
future effects on the recoverability and classification of assets or the amounts
and classification of liabilities that may result from the possible inability of
the Company to continue as a going concern.
3. DUE TO
OFFICERS AND STOCKHOLDERS
During
the nine months ended September 30, 2009, the Company borrowed an additional
$546,530 from its President, Rik Deitsch and repaid $450,000, bringing the total
amount owed to Mr. Deitsch to $1,398,777. This demand loan is
unsecured and bears interest at a rate of 4.0%. Included in the
amount owed to Mr. Deitsch is $198,872 of accrued interest.
In
addition, during the nine months ended September 30, 2009, the Company’s
subsidiary ReceptoPharm repaid $56,250 in loans that it had previously received
from a stockholder. As of September 30, 2009, the balance owed to
this stockholder was $166,974.
4.
STOCKHOLDERS’ DEFICIT
From
January 1 through September 30, 2009, the Company completed private placements
of restricted shares of its common stock, whereby it sold an aggregate of
10,575,000 shares at a price per share of $0.025. The Company received
proceeds of $264,375 in connection with the sale of these shares. The Company
also granted one (1) warrant for each share sold which gives the investor the
right to purchase one (1) additional share until December 31, 2012 at an
exercise price of $0.10 per share.
From July
1 to September 30, 2009, the Company completed private placements of restricted
shares of its common stock, whereby it sold an aggregate of 34,948,750 shares at
a price per share of $0.08. The Company received proceeds of $2,795,900 in
connection with the sale of these shares.
5. STOCK
BASED COMPENSATION
On March
20, 2009, the Company issued 500,000 shares of restricted common stock to each
of two (2) consultants for services rendered. These shares were valued at $0.02
per share which was the fair market value of the Company’s common stock on the
date of grant and accordingly the Company recorded stock based compensation of
$20,000.
On June
4, 2009, the Company’s Board of Directors authorized the issuance of 1,500,000
shares of its restricted common stock to a consultant in exchange for services
rendered. These shares were valued at $0.03 per share which was
the fair market value of the Company’s common stock on the date of
grant. The Company recorded stock based compensation of $45,000 in
connection with the issuance of these shares.
On June
4, 2009, the Company issued 5,000,000 shares of its common stock to a consultant
for services rendered. These shares were issued pursuant to an
effective registration statement on Form S-8 and were not subject to a vesting
period. The fair market value of the shares on the date of grant was
$0.03 and the Company recorded stock based compensation of
$150,000.
On July
29, 2009, the Company’s Board of Directors authorized the issuance of 2,500,000
shares of its restricted common stock to a Director in connection with his
appointment to the Board on such date. These shares were valued at
$0.03 per share which was the fair market value of the Company’s common
stock on the date of grant. The Company recorded stock based
compensation of $75,000 in connection with the issuance of these
shares.
On August
17, 2009, the Company’s Board of Directors authorized the issuance of an
aggregate of 1,400,000 shares of its restricted common stock to a four (4)
consultant in exchange for services rendered. These shares were
valued at $0.05 per share which was the fair market value of the Company’s
common stock on the date of grant. The Company recorded stock based
compensation of $70,000 in connection with the issuance of these
shares.
7
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
September
30, 2009
On August
17, 2009, the Company issued 1,000,000 shares of its common stock to a
consultant for services rendered. These shares were issued pursuant
to an effective registration statement on Form S-8 and were not subject to a
vesting period. The fair market value of the shares on the date of
grant was $0.05 and the Company recorded stock based compensation of
$50,000.
6. STOCK
OPTIONS
A summary
of stock options and warrants is as follows:
|
Number
of
shares
|
Weighted
average
exercise
price
|
Weighted
average
fair
value
|
|||||||||
Balance
December 31, 2008
|
40,140,000
|
$
|
0.11
|
$
|
0.02
|
|||||||
Exercised
|
-
|
-
|
-
|
|||||||||
Issued
|
10,575,000
|
$
|
0.10
|
$
|
0.02
|
|||||||
Forfeited
|
-
|
-
|
-
|
|||||||||
Balance
September 30, 2009
|
50,715,000
|
$
|
0.11
|
$
|
0.02
|
The
following table summarizes information about fixed-price stock options and
warrants:
Exercise
Price
|
Weighted
Average
Number
Outstanding
|
Weighted
Average
Contractual
Life
|
Weighted
Average
Exercise
Price
|
||||||
$0.10
|
47,715,000
|
3.25
years
|
$
|
.10
|
|||||
$0.20
|
1,000,000
|
1.33
years
|
.20
|
||||||
$0.27
|
2,000,000
|
1.50
years
|
$
|
.27
|
|||||
50,715,000
|
All
options are vested and exercisable.
As of
September 30, 2009, the aggregate intrinsic value of all stock options
outstanding and expected to vest was approximately $38,543,000 and the aggregate
intrinsic value of currently exercisable stock options was approximately
$38,543,000. The Intrinsic value of each option share is the
difference between the fair market value of the Company’s common stock and the
exercise price of such option share to the extent it is
“in-the-money”. Aggregate Intrinsic value represents the value that
would have been received by the holders of in-the-money options had they
exercised their options on the last trading day of the year and sold the
underlying shares at the closing stock price on such day. The
intrinsic value calculation is based on the $0.87 closing stock price of the
Company’s common stock on September 30, 2009.
7.
CONTINGENCIES
Patricia Meding,
et. al. v. ReceptoPharm, Inc. f/k/a
Receptogen, Inc.
On August
18, 2006, ReceptoPharm, prior to becoming our wholly owned subsidiary as of
April 2008, was named as a defendant in Patricia Meding, et. al. v. ReceptoPharm,
Inc. f/k/a Receptogen, Inc., Index No.: 18247/06 (New York Supreme Court, Queens
County). The original proceeding, which was filed via a motion for summary
judgment in lieu of a complaint, claimed that ReceptoPharm owed the Plaintiffs,
including Patricia Meding, a former ReceptoPharm officer and director and
several corporations that she claims to own, the sum of $118,928 plus interest
and counsel fees on a series of promissory notes that allegedly were executed in
2001 and 2002. On August 23, 2007, the New York Supreme Court, Queens County
issued a decision denying Plaintiff's motion for summary judgment in lieu of a
complaint, concluding that there were issues of fact concerning the
enforceability of the promissory notes, which precluded summary
judgment.
8
Nutra
Pharma Corp.
Notes to
Consolidated Unaudited Financial Statements
September
30, 2009
On May
23, 2008, the Plaintiffs filed an amended complaint in which they reasserted
their original claims and asserted new claims. The Plaintiffs' amended complaint
seeks damages of no less than $768,506, and alleges that, in or about June 2004,
ReceptoPharm breached its fiduciary duty to the Plaintiffs as ReceptoPharm
shareholders by wrongfully canceling certain of their purported ReceptoPharm
share certificates. ReceptoPharm filed an answer denying the material
allegations of the amended complaint and asserted a series of counterclaims
against the Plaintiffs alleging claims for declaratory judgment, fraud, breach
of fiduciary duty, conversion and unjust enrichment from the promissory notes.
On June 23, 2009, ReceptoPharm submitted a motion to dismiss Plaintiffs' new
claim for breach of fiduciary duty, contending that Plaintiffs had failed to
state a cause of action either for breach of fiduciary duty or for breach of
contract.
On July
22, 2009, during the pendency of ReceptoPharm's motion to dismiss, Plaintiffs
moved to further amend their amended complaint, seeking leave to assert claims
for breach of contract related to an additional 1,214,800 shares of ReceptoPharm
stock. Plaintiffs' proposed new claim contends that Receptopharm
prevented Plaintiffs from exercising their dissenting shareholders' rights
regarding the 1,214,800 shares. ReceptoPharm opposed Plaintiffs' motion for
leave to further amend their amended complaint on multiple independent grounds.
By decision and order dated August 12, 2009, the New York Supreme Court, Queens
County, denied ReceptoPharm's June 23, 2009 motion to dismiss. The Court
determined that even though Plaintiffs had not stated a claim for breach of
contract or breach of fiduciary duty, they had stated an equitable claim for
"wrongful cancellation of stock certificates". On September 22, 2009,
Receptopharm simultaneously moved to renew and reargue the Queens County Supreme
Court's denial of its motion to dismiss, and filed a notice of appeal regarding
that denial, contending that the Court either misapprehended or overlooked
certain factual and legal issues in arriving at its decision. In separate
October 13, 2009 decisions, the Queens County Supreme Court denied Plaintiffs'
motion to further amend their amended complaint to assert claims regarding the
additional 1,214,800 shares of Receptopharm stock, and granted ReceptoPharm's
motion to renew and reargue the Court’s decision on its motion to dismiss.
However, the Court’s denial of Plaintiffs' motion to further amend was without
prejudice to renewal and Plaintiffs may once again move to amend their amended
complaint, provided they adhere to certain technical prerequisites. Furthermore,
while the Court granted ReceptoPharm's motion to renew and reargue the motion to
dismiss, it then once again denied the motion to dismiss upon renewal and
reargument. Accordingly, Receptopharm filed a notice of appeal with respect to
the Court's decision on renewal and reargument, and will move to consolidate the
renewal/reargument appeal with the pending appeal of the underlying decision on
the motion to dismiss. Discovery in this matter has commenced, but
the parties have only exchanged initial documents and no depositions have yet
taken place. We intend to vigorously contest this matter.
8.
SUBSEQUENT EVENTS
Subsequent
to September 30, 2009, the Company repaid $150,000 of a loan due to an
officer.
9
Forward
Looking Statements
This
Quarterly Report on Form 10-Q for the period ending September 30, 2009 contains
forward-looking statements that involve risks and uncertainties, as well as
assumptions that, if they never materialize or prove incorrect, could cause the
results of Nutra Pharma Corp. and its subsidiaries (hereafter referred to as
"we", "our" or "us") to differ materially from those expressed or implied by
such forward-looking statements. The words or phrases "would be," "will allow,
"intends to," "will likely result," "are expected to," "will continue," "is
anticipated," "estimate," "project," or similar expressions are intended to
identify "forward-looking statements." We are subject to the following risks,
among others, in connection with our business: (a) we have
experienced recurring net losses and have a working capital deficiency, which
raises substantial doubt about our ability to continue as a going concern; (b)
our history of losses makes it difficult to evaluate our current and future
business and our future financial results; (c) our operational plans
are dependent upon generating revenues from product sales and clinical research
services and/or obtaining equity or other financing; (d) we are
subject to substantial U.S. Food and Drug Administration ("FDA") and other
regulations which may increase our costs or otherwise adversely affect our
operations; (e) a market for our products may never develop; (f) if we fail to
adequately protect our patents, we may be unable to proceed with development of
potential drug products; (g) we are dependent upon patents, licenses and other
proprietary rights from third parties; should we lose such rights our operations
will be negatively affected; (h) to date, we have not generated any significant
revenues; (i) to date, none of our proposed products have received FDA approval;
(j) should we continue to have insufficient funds to conduct our operations,
development of our possible future products will be negatively impacted; (k) we
may be unable to compete against our competitors in the medical device and
biopharmaceutical markets since our competitors have superior financial and
technical resources than we do; (l) we completed our acquisition of ReceptoPharm
as our wholly owned subsidiary in April 2008; our operations and financial
condition will be negatively affected if we fail to efficiently manage their
operations and their expansion plans pending adequate financing; and (m) if we
fail to generate adequate revenues from our first product, Cobroxin, or we are
subject to legal judgments against us for claimed negative effects of Cobroxin,
our financial condition will be negatively affected.
All
statements other than statements of historical fact are statements that could be
deemed forward-looking statements, including: (a) any projections of revenue,
gross margin, expenses, earnings or losses from operations, synergies or other
financial items; (b) any statements of the plans, strategies and objectives of
management for future operations; and (c) any statement concerning developments,
plans, or performance. Unless otherwise required by applicable law, we do not
undertake and we specifically disclaim any obligation to update any
forward-looking statements to reflect occurrences, developments, unanticipated
events or circumstances after the date of such statement.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of
Operations
This
section must be read in conjunction with our unaudited Financial Statements and
accompanying notes included in Item 1 above.
Overview
We are a
biopharmaceutical company specializing in the acquisition, licensing and
commercialization of pharmaceutical products and technologies for the management
of neurological disorders, cancer, autoimmune and infectious diseases.
Through our subsidiaries, ReceptoPharm Inc. and Designer Diagnostics, Inc., we
carry out basic drug discovery research and clinical development and seek
strategic licensing partnerships to reduce the risks associated with the drug
development process. ReceptoPharm is developing technologies for the production
of drugs which treat Multiple Sclerosis ("MS"), Adrenomyeloneuropathy (“AMN”),
Rheumatoid Arthritis (“RA”), HIV and pain. Designer Diagnostics is engaged
in the research and development of diagnostic test kits designed to be used for
the rapid identification of infectious diseases such as Paratuberculosis
(para-TB) and Mycobacterium avium-intracellulare (MAI).
Cobroxin
In
October 2009, we launched our first consumer product, Cobroxin, an
over-the-counter pain reliever designed to treat moderate to severe (Stage 2)
chronic pain. Cobroxin is a homeopathic drug that was developed over a
period of approximately 6 years as a result of ReceptoPharm’s on-going research
into treatments for neurological and autoimmune disorders.
Cobroxin
is currently available as a two (2) ounce topical gel for treating joint pain
and pain associated with arthritis and repetitive stress, and as a one (1) ounce
oral spray for treating lower back pain, migraines, neck aches, shoulder pain,
cramps, and neuropathic pain. Both the topical gel and oral spray are packaged
and sold as a 1-month supply.
Cobroxin
offers several benefits as an analgesic. With increasing concern about consumers
using opioid and acetaminophen-based pain relievers, Cobroxin provides an
alternative that does not rely on opiates or non-steroidal anti-inflammatory
drugs, otherwise known as NSAIDs, for its pain relieving effects.
One of
the benefits to Cobroxin is its well defined safety profile. Since the early
1930s, the active pharmaceutical ingredient (API) of Cobroxin, Asian cobra
venom, has been studied in more than 46 human clinical studies. The data from
these studies provide clinical evidence that cobra venom provides an effective
treatment for pain with few side effects.
Additional
benefits to Cobroxin include:
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·
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Safe
and Effective
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·
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All
Natural
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·
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Long-Acting
|
|
·
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Easy
to Use
|
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·
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Non-Narcotic
|
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·
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Non-Addictive
|
|
·
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Analgesic
and Anti-Inflammatory
|
Potential
side effects from use of Cobroxin include headache, nausea, vomiting, sore
throat, allergic rhinitis and coughing.
Pain
Market
Pain is
one of the most common reasons that patients seek medical care and accounts for
half of all physician office visits in the United States. According
to the American Pain Foundation, a non-profit organization, as of 2007 at least
25 million people in the United States experience acute pain as a result of
injury or surgery. Additionally, more than 50 million people in the
United States are affected by ongoing chronic pain.
10
The
market for pain management products in the United States, including prescription
and nonprescription analgesics, reached $20.4 billion in 2005 according to an
April 2006 published report by Medtech Insight, a market research
firm. According to a more recent report conducted by IMS Health, a
market research firm, the sales of opioid-based prescription pain drugs,
including OxyContin, exceeded $6 billion in 2008. The current market for pain
drugs is expected to continue to grow according to Global Industry Analysts
Inc., a market research firm which believes that the aging baby boomer
population will continue to trigger growth in this market resulting in a market
size of $35.5 billion by 2015.
Regulation
The
active pharmaceutical ingredient (API) in Cobroxin, Asian cobra venom, has an
approved United States monograph under the Homeopathic Pharmacopoeia of the
United States (HPUS), which allowed us to register Cobroxin with the FDA as a
homeopathic drug. A United States monograph is a prescribed
formulation for the production of any drug or product that is recognized by law
for a specific application and that may be introduced into commerce. This
registration process is required by the FDA to maintain full compliance of
companies marketing and selling medicines classified as
homeopathic. On August 24, 2009, we announced that we successfully
completed submission of final packaging and labeling to the FDA to begin selling
our over-the-counter pain reliever, Cobroxin.
In
addition, the FDA requires those companies manufacturing homeopathic medicines
to have their facilities certified as Good Manufacturing Practice
(“GMP”). As of October 2005, ReceptoPharm’s manufacturing and
laboratory facility is fully compliant with its GMP certification. In
March 2009, ReceptoPharm received an ISO Class 5 certification for its clean
room facility. An ISO Class 5 certification is a type of classification granted
for a clean room facility according to the number and size of particles
permitted per volume of air. An ISO Class 5 clean room has at most, 3,500
particles per square meter.
Manufacturing
Manufacturing
Cobroxin entails a two-step process, the first of which consists of ReceptoPharm
manufacturing the bulk raw materials and completing the dilution levels of
Cobroxin’s active pharmaceutical ingredient (API) as provided for in the
Homeopathic Pharmacopoeia of the United States, which is a compilation of
continuously updated statements of Homeopathic Pharmacopoeia standards and
monographs as recognized by that organization. Once this process is completed,
the second step entails transport of raw materials to a third-party manufacturer
that completes the final mixing, bottling and shipping processes.
Marketing
and Distribution
In August
2009, we completed an agreement with XenaCare Holdings, Inc. (“XenaCare”)
granting XenaCare the exclusive license to market and distribute Cobroxin within
the United States. To maintain this market exclusivity, XenaCare is required to
meet certain minimum performance requirements.
In
mid-October 2009, XenaCare began selling Cobroxin online through its product
website Cobroxin.com. XenaCare is continuing to distribute Cobroxin to both
online and brick-and-mortar retailers. We expect Cobroxin to be available
nationwide during the first quarter of 2010.
To
support ongoing sales, XenaCare intends to conduct an extensive marketing
campaign, consisting of print, online and broadcast advertising. To
date, XenaCare has accomplished the following:
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·
|
Launched
its initial print advertising campaign with ads appearing in Prevention,
Health, Star, Woman's World, Soap Opera, and Self
magazines.
|
|
·
|
Announced
that the Chain Drug Marketing Association (“CDMA”) will begin making
Cobroxin available for purchase through its 6,000 member
pharmacies.
|
|
·
|
Announced
an agreement to advertise Cobroxin in the official publication for NASCAR,
Racing One, for the 2010 racing
season.
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11
|
·
|
Announced
completion of an agreement to advertise Cobroxin in the 2009 National
Football Alumni Guide and Yearbook, a publication that is distributed to
football fans, current and past NFL players, team owners, coaches and
league executives.
|
Additionally,
XenaCare plans to begin its broadcast advertising campaigns during the first
quarter of 2010.
On
September 21, 2009, we announced our plan to begin the drug registration process
in Canada and Europe for Cobroxin. On November 12, 2009, we announced
plans to begin the drug registration process in South America for
Cobroxin.
Moving
into 2010, we plan to expand the presence of our pain reliever internationally
through a series of out-licensing arrangements. While many countries
adopt a similar regulation to that of the United States for registering
homeopathic drugs, the international application process is more complex and may
take longer than in the United States.
Intellectual
Property
On August
31, 2009, we filed a trademark application for the word mark “Cobroxin for
Chronic Pain” with the United States Patent and Trademark
Office. Additionally, on August 13, 2009, ReceptoPharm filed a
provisional patent application with the United States Patent and Trademark
Office for the oral formulation and delivery of cobra venom for the treatment of
pain. There is no assurance that ReceptoPharm’s patent will be approved by the
United States Patent and Trademark Office.
Nyloxin
Rx
In
October 2009, we announced our plans to launch Nyloxin Rx, a prescription pain
reliever for severe (Stage 3) chronic pain. Similar to Cobroxin, the active
pharmaceutical ingredient in Nyloxin Rx is Asian cobra venom. The primary
difference between Nyloxin Rx and Cobroxin is the dilution level of the venom,
with Nyloxin Rx being more concentrated. We intend to begin selling Nyloxin Rx
during the fourth quarter of 2009 subject to our registration of Nyloxin Rx with
the FDA. Additionally, we plan to complete two additional human clinical studies
aimed at comparing the efficacy of Nyloxin Rx to currently available
prescription pain relievers, one of which we plan to begin during the fourth
quarter of 2009 and the second clinical study we plan to begin during the second
quarter of 2010.
ReceptoPharm
Over the
next twelve months, ReceptoPharm will continue to oversee the manufacturing of
Cobroxin, both at its Good Manufacturing Practice (GMP) certified facility and
at the third-party manufacturing and bottling facility. Additionally,
ReceptoPharm will also be responsible for acquiring appropriate amounts of Asian
cobra venom required to manufacture Cobroxin.
ReceptoPharm
also plans to begin additional clinical studies for its prescription pain
reliever, Nyloxin. These studies will be designed to compare the efficacy of
Nyloxin to other prescription strength pain relievers. The first clinical study
is planned to begin within the fourth quarter of 2009 and the subsequent study
is planned to begin by the second quarter of 2010. A ReceptoPharm study
published in Toxicon, which is the journal of the International Society of
Toxinology, showed that ReceptoPharm’s leading drug treatment for the treatment
of pain, RPI-78 had pain reducing effects that lasted four times as long as
morphine without the negative side effects associated with opiod-based pain
relievers.
In
February 2009, ReceptoPharm filed a patent application with the United States
Patent and Trademark Office for the use of RPI-78 as a novel method for treating
arthritis in humans. Also in February 2009, ReceptoPharm, in collaboration with
Soochow University in China published positive data from its recent animal
studies on the use of RPI-78 (Cobratoxin) as a method for treating
arthritis.
12
ReceptoPharm
is also engaged in providing contract research services to third-party
biotechnology and pharmaceutical companies. ReceptoPharm announced in December
2008 that it had received a clinical drug supply contract for Celtic Biotech, an
Ireland-based biotechnology company developing a treatment to
cancer. ReceptoPharm fulfilled this contract during the fourth
quarter of 2009 and will continue to seek additional clients for its contract
research services over the next twelve months.
In the
areas of HIV and MS, ReceptoPharm plans to conduct clinical studies of its HIV
and MS drugs under development. These "Phase II" studies will either prove or
disprove the preliminary efficacy of ReceptoPharm's HIV and MS drugs under
development. ReceptoPharm is in the process of attempting to secure agreements
with third parties to conduct such clinical studies.
In
January of 2007, ReceptoPharm began their clinical study in
Adrenomyeloneuropathy (“AMN”). AMN is a genetic disorder that affects
the central nervous system. The disease causes neurological disability that is
slowly progressive over several decades. Throughout our twelve month Plan of
Operations, ReceptoPharm plans to complete analysis of this clinical study. The
clinical study, which was completed at the Charles Dent Metabolic Unity located
in London, England, is classified as a Phase IIb/IIIa study. Once the results
are analyzed and presented to the regulatory agencies, it could be determined to
be the final step required for regulatory approval of the drug.
Designer
Diagnostics
Designer
Diagnostics’ Nontuberculous Mycobacteria (“NTM”) test kits are now being
marketed and will continue to be marketed to a global audience,
including:
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·
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Hospitals;
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Pharmaceutical
companies;
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·
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Biotechnology
companies;
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·
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Medical
device distributors;
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·
|
Governmental
organizations;
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·
|
Environmental
testing facilities; and
|
|
·
|
Government
water and soil testing facilities at the local, state and federal
levels.
|
Over the
next twelve months, Designer Diagnostics will attempt to distribute the test
kits to the above companies and organizations. Our first sales
occurred during our second quarter of 2006 with limited sales throughout
2007 and 2008. Our sales efforts during 2007, 2008 and thus far in 2009 have
been inhibited by the necessity for FDA validation prior to active marketing in
United States based markets. These markets include the CDC (Centers for Disease
Control and Prevention) and the WHO (World Health Organization). Researchers at
National Jewish Hospital in Denver, Colorado are currently validating Designer
Diagnostics’ TB and NTM Test Kits. This research has been protracted due to
budget restrictions at the hospital as well as our own limited funding. We
currently anticipate the completion of this research and regulatory filing by
the second quarter of 2010.
Additionally,
the test kits are now utilized for environmental analysis for the presence of
NTM in the water and/or soil. This allows investigators to easily find the
source of contamination and may greatly reduce NTM infections and
outbreaks. When, and if, sales of the test kits exceed our
operating budget, we will use the test kit proceeds to fund drug research and
clinical studies.
Designer
Diagnostics’ management will attempt to develop a distribution network and
actively market the test kits to supply administrators of companies and/or
governmental organizations in the following markets: hospitals; pharmaceutical;
biotechnology; medical device distributors. Designer Diagnostics will also
attempt to acquire other medical diagnostic products to develop that same
distribution market. Designer Diagnostic’s management will also seek license
agreements to develop revenue streams consisting of drug discovery, drug
development, and new medical device technologies.
Liquidity
and Capital Resources
Our
independent registered public accounting firm issued a going concern opinion on
our audited financial statements for the fiscal year ended December 31,
2008. Our financial statements for the period ending September 30,
2009 are presented on a going concern basis, which contemplates the realization
of assets and satisfaction of liabilities in the normal course of our
business. Since our inception, we have experienced recurring net
losses and at September 30, 2009, we had an accumulated deficit of $25,859,328
and negative working capital of $690,661.
13
To fund
costs associated with our operations, we have been relied upon loans from our
Chief Executive Officer, Rik Deitsch. During the nine months ended
September 30, 2009, we borrowed an additional $546,530 from Mr.
Deitsch. During September 2009, we repaid $450,000 of such loans; as
of September 30, 2009, this repayment reduced the balance owed to Mr. Deitsch to
$1,398,777. In October 2009, we repaid an additional $150,000 to Mr.
Deitsch.
During
the quarterly period ending September 30, 2009, we raised $3,025,275 through
private placements of shares of our common stock. We expect to
utilize the proceeds from these private placements to manufacture our Cobroxin
line of products, conduct additional research and clinical trials for
ReceptoPharm’s leading drug candidate RPI-78, and reduce our level of
debt. We estimate that we will require approximately $1,200,000 to
fund our existing operations and the operations of our subsidiaries ReceptoPharm
and Designer Diagnostics over the next twelve months. These costs
include: (i) compensation for six (6) full-time employees; (ii) compensation for
two (2) consultants who we deem critical to our business; (iii) general office
expenses including rent and utilities; (iv) product liability insurance; and (v)
outside legal and accounting services. These costs reflected in
(i) – (v) do not include research and development costs or other costs
associated with clinical studies.
We began
generating revenues from the sale of Cobroxin in the fourth quarter of
2009. Our ability to meet our future operating expenses is highly
dependent on the amount of such future revenues. To the extent that
future revenues from the sale of Cobroxin are insufficient to cover our
operating expenses we may need to raise additional equity capital, which could
result in substantial dilution to existing shareholders. There can be
no assurance that we will be able to raise sufficient equity capital to fund our
working capital requirements on terms acceptable to us, or at all. We
may also seek additional loans from our officers and directors; however, there
can be no assurance that we will be successful in securing such additional
loans.
In the
event that we do not obtain adequate financing or if we do not adequately
implement an alternative plan of operations that enables us to conduct
operations without having received adequate financing, we may have to liquidate
our business and undertake any or all of the following actions:
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·
|
Sell
or dispose of our assets, if any;
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·
|
Pay
our liabilities in order of priority, if we have available cash to pay
such liabilities;
|
·
|
If
any cash remains after we satisfy amounts due to our creditors, distribute
any remaining cash to our shareholders in an amount equal to the net
market value of our net assets;
|
·
|
File
a Certificate of Dissolution with the State of California to dissolve our
corporation and close our business;
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·
|
Make
the appropriate filings with the Securities and Exchange Commission so
that we will no longer be required to file periodic and other required
reports with the Securities and Exchange Commission, if, in fact, we are a
reporting company at that time; and
|
·
|
Make
the appropriate filings with the Financial Industry Regulatory Authority
(FINRA) to effect a delisting of our common stock, if, in fact, our common
stock is trading on the Over-the-Counter Bulletin Board at that
time.
|
Based
upon our current assets, however, we will not have the ability to distribute any
cash to our shareholders. If we have any liabilities that we are unable to
satisfy and we qualify for protection under the U.S. Bankruptcy Code, we may
voluntarily file for reorganization under Chapter 11 or liquidation under
Chapter 7. Our creditors may also file a Chapter 7 or Chapter 11
bankruptcy action against us. If our creditors or we file for Chapter
7 or Chapter 11 bankruptcy, our creditors will take priority over our
shareholders. If we fail to file for bankruptcy under Chapter 7 or
Chapter 11 and we have creditors, such creditors may institute proceedings
against us seeking forfeiture of our assets, if any.
14
We
do not know and cannot determine which, if any, of these actions we will be
forced to take. If any of these foregoing events occur, you could
lose your entire investment in our common stock.
Results
of Operations – Comparison of Three Month Periods Ending September 30, 2008 and
September 30, 2009
Revenue
for the three months ended September 30, 2009 was $900 compared to $3,045 for
the comparable period in 2008. Revenue for the current quarterly
period was generated from the provision of clinical research services to
independent third parties. These clinical research services are
performed by our wholly owned subsidiary, ReceptoPharm. Revenue for
the comparable period in 2008 was attributable to the sale of test kits by our
subsidiary, Designer Diagnostics. We did not sell any test kits in
the quarter ended September 30, 2009.
General
and administrative expenses increased $17,070 or 4% from $431,321 for the
quarter ended September 30, 2008 to $448,391 for the quarter ended September 30,
2009. This increase is due primarily to an increase in consulting
expenses incurred by ReceptoPharm. Research and development expenses
incurred by ReceptoPharm were $91,580 for the quarter ended September 30,
2009. These expenses were related to ongoing research activities
pertaining to ReceptoPharm’s leading drug compound RPI-78. Also
included in research and development expenses are certain costs related to the
commercialization of our Cobroxin products.
Stock
based compensation increased $120,000 from $75,000 for the quarter ended
September 30, 2008 to $195,000 for the comparable quarter in 2009. We
issued 2,500,000 shares in exchange for compensation at value of $0.03 per share
in 2008 compared to 4,900,000 shares at a weighted average value of $0.0398 in
2009.
Interest
expense increased from $12,649 for the quarter ended September 30, 2008 to
$20,957 for the comparable quarter in 2009. This increase was
attributable to an increased level of indebtedness related to loans made to us
by our Chief Executive Officer.
We
incurred a net loss of $755,028 for the three month period ending September 30,
2009 compared to a net loss of $516,580 for the comparable period in
2008. The increase in net loss is primarily attributable to the
increase in stock based compensation and research and development expenses as
discussed above.
Results
of Operations – Comparison of Nine Month Periods Ending September 30, 2008 and
September 30, 2009
Revenue
for the nine months ended September 30, 2009 was $27,528 compared to $3,045 for
the comparable period in 2008. Revenue for the current nine-month
period was generated from the provision of clinical research services to
independent third parties. These clinical research services are
performed by our wholly owned subsidiary, ReceptoPharm. Revenue for
the comparable period in 2008 was attributable to the sale of test kits by our
subsidiary, Designer Diagnostics. We did not sell any test kits in
the nine-month period ended September 30, 2009.
General
and administrative expenses increased $69,358 or 7.3% from $950,838 for the nine
months ended September 30, 2008 to $1,020,196 for the nine months ended
September 30, 2009. This increase is due primarily to an increase in
consulting expenses incurred by ReceptoPharm. Research and
development expenses incurred by ReceptoPharm were $126,955 for the nine months
ended September 30, 2009. These expenses were related to ongoing
research activities pertaining to ReceptoPharm’s leading drug compound
RPI-78. Also included in research and development expenses are
certain costs related to the commercialization of our Cobroxin
products.
Stock
based compensation decreased $90,000 from $500,000 for the nine months ended
September 30, 2008 to $410,000 for the comparable quarter in 2009. We
issued 19,500,000 shares in exchange for compensation at a weighted average
value of $0.026 per share in 2008 compared to 12,400,000 shares at a weighted
average value of $0.033 in 2009.
Interest
expense increased from $42,640 for the nine months ended September 30, 2008 to
$55,243 for the comparable period in 2009. This increase was
attributable to an increased level of indebtedness related to loans made to us
by our Chief Executive Officer.
15
We
incurred a net loss of $1,588,126 for the nine month period ending September 30,
2009 compared to a net loss of $1,491,088 for the comparable period in
2008. The increase in net loss is primarily attributable to an
overall increase in general and administrative expenses and research and
development expenses as discussed above.
Uncertainties
and Trends
Our
operations and possible revenues are dependent now and in the future upon the
following factors:
·
|
Whether
we successfully develop and commercialize products from our research and
development activities.
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·
|
If
we fail to compete effectively in the intensely competitive biotechnology
area, our operations and market position will be negatively
impacted.
|
·
|
If
we fail to successfully execute our planned partnering and out-licensing
of products or technologies, our future performance will be adversely
affected.
|
·
|
The
recent economic downturn and related credit and financial market crisis
may adversely affect our ability to obtain financing, conduct our
operations and realize opportunities to successfully bring our
technologies to market.
|
·
|
Biotechnology
industry related litigation is substantial and may continue to rise,
leading to greater costs and unpredictable
litigation.
|
·
|
If
we fail to comply with extensive legal/regulatory requirements affecting
the healthcare industry, we will face increased costs, and possibly
penalties and business losses.
|
Off-Balance
Sheet Arrangements
We have
not entered into any transaction, agreement or other contractual arrangement
with an entity unconsolidated with us under whom we have:
·
|
an
obligation under a guarantee contract;
|
·
|
a
retained or contingent interest in assets transferred to the
unconsolidated entity or similar arrangement that serves as credit,
liquidity or market risk support to such entity for such
assets;
|
·
|
any
obligation, including a contingent obligation, under a contract that would
be accounted for as a derivative instrument,
or;
|
·
|
any
obligation, including a contingent obligation, arising out of a variable
interest in an unconsolidated entity that is held by us and material to us
where such entity provides financing, liquidity, market risk or credit
risk support to, or engages in leasing, hedging or research and
development services with us.
|
We do not
have any off-balance sheet arrangements or commitments that have a current or
future effect on its financial condition, changes in financial condition,
revenues or expenses, results of operations, liquidity, capital expenditures, or
capital resources that is material, other than those which may be disclosed in
this Management’s Discussion and Analysis of Financial Condition and the audited
Consolidated Financial Statements and related notes.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Not
applicable
16
Item
4. Controls and Procedures
As
required by Rule 13a-15 under the Securities Exchange Act of 1934, as amended
(“Exchange Act) we carried out an evaluation of the effectiveness of the design
and operation of our disclosure controls and procedures. This evaluation was
carried out under the supervision of our Chief Executive Officer who is also our
Principal Financial and Accounting Officer. Following this inspection, this
officer concluded that our disclosure controls and procedures were effective as
of September 30, 2009, the end of the period covered by this
report. There have been no changes in our internal controls or in
other factors, which have materially affected, or are reasonably likely to
materially affect, internal controls subsequent to the date of the
evaluation.
Disclosure
controls and procedures are controls and other procedures that are designed to
ensure that information required to be disclosed in our reports filed or
submitted under the Exchange Act is recorded, processed, summarized and
reported, within the time periods specified in the Securities and Exchange
Commission’s rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information
required to be disclosed in our reports filed under the Exchange Act is
accumulated and communicated to management, including our Chief Executive
Officer, who also acted as our Principal Financial Officer as appropriate, to
allow timely decisions regarding required disclosure.
PART
II. OTHER
INFORMATION
Item 1. Legal Proceedings
Patricia Meding,
et. al. v. ReceptoPharm, Inc. f/k/a
Receptogen, Inc.
On August
18, 2006, ReceptoPharm, prior to becoming our wholly owned subsidiary as of
April 2008, was named as a defendant in Patricia Meding, et. al. v. ReceptoPharm,
Inc. f/k/a Receptogen, Inc., Index No.: 18247/06 (New York Supreme Court, Queens
County). The original proceeding, which was filed via a motion for summary
judgment in lieu of a complaint, claimed that ReceptoPharm owed the Plaintiffs,
including Patricia Meding, a former ReceptoPharm officer and director and
several corporations that she claims to own, the sum of $118,928.15 plus
interest and counsel fees on a series of promissory notes that allegedly were
executed in 2001 and 2002. On August 23, 2007, the New York Supreme Court,
Queens County issued a decision denying Plaintiff's motion for summary judgment
in lieu of a complaint, concluding that there were issues of fact concerning the
enforceability of the promissory notes, which precluded summary
judgment.
On May
23, 2008, the Plaintiffs filed an amended complaint in which they reasserted
their original claims and asserted new claims. The Plaintiffs' amended complaint
seeks damages of no less than $768,506, and alleges that, in or about June 2004,
ReceptoPharm breached its fiduciary duty to the Plaintiffs as ReceptoPharm
shareholders by wrongfully canceling certain of their purported ReceptoPharm
share certificates. ReceptoPharm filed an answer denying the material
allegations of the amended complaint and asserted a series of counterclaims
against the Plaintiffs alleging claims for declaratory judgment, fraud, breach
of fiduciary duty, conversion and unjust enrichment from the promissory notes.
On June 23, 2009, ReceptoPharm submitted a motion to dismiss Plaintiffs' new
claim for breach of fiduciary duty, contending that Plaintiffs had failed to
state a cause of action either for breach of fiduciary duty or for breach of
contract.
On July
22, 2009, during the pendency of ReceptoPharm's motion to dismiss, Plaintiffs
moved to further amend their amended complaint, seeking leave to assert claims
for breach of contract related to an additional 1,214,800 shares of ReceptoPharm
stock. Plaintiffs' proposed new claim contends that Receptopharm
prevented Plaintiffs from exercising their dissenting shareholders' rights
regarding the 1,214,800 shares. ReceptoPharm opposed Plaintiffs' motion for
leave to further amend their amended complaint on multiple independent grounds.
By decision and order dated August 12, 2009, the New York Supreme Court, Queens
County, denied ReceptoPharm's June 23, 2009 motion to dismiss. The Court
determined that even though Plaintiffs had not stated a claim for breach of
contract or breach of fiduciary duty, they had stated an equitable claim for
"wrongful cancellation of stock certificates". On September 22, 2009,
Receptopharm simultaneously moved to renew and reargue the Queens County Supreme
Court's denial of its motion to dismiss, and filed a notice of appeal regarding
that denial, contending that the Court either misapprehended or overlooked
certain factual and legal issues in arriving at its decision. In separate
October 13, 2009 decisions, the Queens County Supreme Court denied Plaintiffs'
motion to further amend their amended complaint to assert claims regarding the
additional 1,214,800 shares of Receptopharm stock, and granted ReceptoPharm's
motion to renew and reargue the Court’s decision on its motion to dismiss.
However, the Court’s denial of Plaintiffs' motion to further amend was without
prejudice to renewal and Plaintiffs may once again move to amend their amended
complaint, provided they adhere to certain technical prerequisites. Furthermore,
while the Court granted ReceptoPharm's motion to renew and reargue the motion to
dismiss, it then once again denied the motion to dismiss upon renewal and
reargument. Accordingly, Receptopharm filed a notice of appeal with respect to
the Court's decision on renewal and reargument, and will move to consolidate the
renewal/reargument appeal with the pending appeal of the underlying decision on
the motion to dismiss. Discovery in this matter has commenced, but
the parties have only exchanged initial documents and no depositions have yet
taken place. We intend to vigorously contest this matter.
17
There are
no other legal proceedings that occurred during our Fiscal Quarter ending
September 30, 2009 that are reportable.
Item
1A. Risk Factors
As a
Smaller Reporting Company, we are not required to provide the information
required by this item; however, our disclosure under Forward Looking Statements
above on page 10 of this report contains various risks that we are subject
to.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
From July
1, 2009 through September 30, 2009, we sold 9,175,000 shares of our common stock
to five (5) accredited investors at a price of $0.025 for aggregate
proceeds of $229,375. We also granted one (1) warrant for each share
sold, which gives each accredited investor the right to purchase one (1)
additional share until December 31, 2010 at an exercise price of
$0.10.
From
September 1, 2009 to September 30, 2009, we sold 34,948,750 shares of our
common stock to sixty-five (65) accredited investors at $0.08 per share for
aggregate proceeds of $2,795,900.
On August
31, 2009, we issued an aggregate of 1,400,000 shares of our restricted common
stock to four (4) consultants in share denominations
of 250,000, 750,000, 100,000, and 300,000. These
shares were issued in exchange for services rendered and were valued
at $0.05 per share, which was the fair market value of our common stock on the
date of grant.
On
September 17, 2009, we issued 2,500,000 shares of our restricted common stock to
a Director in connection with his appointment to our Board of
Directors. These shares were valued at $0.03 per share
which was the fair market value of our common stock on the date of
grant.
We relied
upon Sections 4(2) and 4(6) of the Securities Act of 1933, as amended ("the
Act") in connection with the above issuances of the securities to the above
accredited investors.
Item
3. Defaults Upon Senior Securities
None
Item
4. Submission of Matters to a Vote of Security Holders
None
Item 5. Other Information
None
18
Item 6. Exhibits
Exhibit No.
|
Title
|
|
31.1
|
Certification of
Chief Executive Officer and Chief Financial Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification
of Chief Executive Officer and Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of
2002.
|
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.
Dated:
November 18, 2009
|
NUTRA
PHARMA CORP.
|
Registrant
|
/s/
Rik J. Deitsch
|
Rik
J. Deitsch
|
Chief
Executive Officer/Chief Financial
Officer
|
19