ProPhase Labs, Inc. - Quarter Report: 2010 March (Form 10-Q)
FORM
10-Q
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
For the
quarterly period ended March 31,
2010
OR
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THESECURITIES EXCHANGE ACT OF
1934
|
For the
transition period from ______________ to ______________
Commission
file number 0-21617
ProPhase Labs, Inc.
(formerly
known as The Quigley Corporation)
(Exact
Name of Registrant as Specified in Its Charter)
Nevada
|
23-2577138
|
|
(State
or other jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
|
incorporation
or organization)
|
621 N. Shady Retreat Road, Doylestown,
Pennsylvania
|
18901
|
(Address
of principal executive office)
|
(Zip
Code)
|
(215) 345-0919
|
(Registrant’s
telephone number, including area
code)
|
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the 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 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 during
the preceding 12 months (or shorter period that the registration was
required to submit and post such
files). Yes o No o
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer or a smaller reporting company (See
definition of “large accelerated filer”, "accelerated filer”, “non-accelerated
filer" and “smaller reporting company” in Rule 12b-2 of the Exchange
Act. (Check one):
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
Indicate
the number of shares outstanding of each of the issuer’s classes of common
stock, as of the latest practicable date.
Class
|
Outstanding at May 13,
2010
|
|
Common
Stock, $0.0005 par value
|
14,620,637
|
ProPhase
Labs, Inc. and Subsidiaries
TABLE
OF CONTENTS
PAGE
|
||
PART
I.
|
FINANCIAL
INFORMATION
|
|
Item
1.
|
Financial
Statements
|
|
Condensed
Consolidated Balance Sheets as of March 31, 2010 (unaudited) and December
31, 2009
|
3
|
|
Condensed
Consolidated Statements of Operations for the Three Months Ended March 31,
2010 and 2009 (unaudited)
|
4
|
|
Condensed
Consolidated Statement of Stockholders’ Equity for the Three Months
Ended
|
||
March
31, 2010 (unaudited)
|
5
|
|
Condensed
Consolidated Statements of Cash Flows for the Three Months
Ended
|
||
March
31, 2010 and 2009 (unaudited)
|
6
|
|
Notes
to Condensed Consolidated Financial Statements
|
7
|
|
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations
|
19
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Item 3. |
Quantitative
and Qualitative Disclosures About Market Risk
|
28
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Item 4. |
Controls
and Procedures
|
28
|
PART II.
|
OTHER
INFORMATION
|
|
Item
1.
|
Legal
Proceedings
|
30
|
Item
1A.
|
Risk
Factors
|
30
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
31
|
Item
3.
|
Defaults
Upon Senior Securities
|
31
|
Item
5.
|
Other
Information
|
31
|
Item
6.
|
Exhibits
|
31
|
Signatures |
32
|
|
Certifications |
33
|
2
PART
I. FINANCIAL INFORMATION
Item
1. Financial
Statements.
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Balance Sheets
(in
thousands, except share and per share amounts)
March 31, 2010
|
December 31, 2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Cash
and cash equivalents (Note 2)
|
$ | 12,352 | $ | 12,801 | ||||
Restricted
cash (Note 3)
|
500 | - | ||||||
Accounts
receivable, net of doubtful accounts of $22 and $23 respectively (Note
2)
|
1,357 | 3,599 | ||||||
Inventory,
net (Note 2)
|
1,134 | 1,405 | ||||||
Prepaid
expenses and other current assets
|
574 | 803 | ||||||
Assets
held for sale (Note 2)
|
138 | 138 | ||||||
Total
current assets
|
16,055 | 18,746 | ||||||
Intangible
asset, licensed technology (Note 3)
|
3,577 | - | ||||||
Property,
plant and equipment, net of accumulated depreciation of $3,237 and $3,155,
respectively (Note 2)
|
2,535 | 2,572 | ||||||
Other
assets
|
12 | 12 | ||||||
$ | 22,179 | $ | 21,330 | |||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
LIABILITIES:
|
||||||||
Accounts
payable
|
$ | 306 | $ | 708 | ||||
Accrued
royalties and sales commissions (Note 5)
|
3,529 | 3,681 | ||||||
Accrued
advertising and other allowances
|
2,125 | 2,124 | ||||||
Other
current liabilities
|
603 | 758 | ||||||
Total
current liabilities
|
6,563 | 7,271 | ||||||
Commitments
and contigencies (Note 5)
|
- | - | ||||||
STOCKHOLDERS'
EQUITY:
|
||||||||
Common
Stock, $.0005 par value; authorized 50,000,000; issued: 19,145,440
and 17,679,436 shares, respectively (Note 6)
|
10 | 9 | ||||||
Additional
paid-in-capital
|
40,344 | 37,726 | ||||||
Retained
earnings
|
450 | 1,512 | ||||||
Treasury
stock, at cost, 4,646,053 and 4,646,053 shares,
respectively
|
(25,188 | ) | (25,188 | ) | ||||
Total
stockholders' equity
|
15,616 | 14,059 | ||||||
$ | 22,179 | $ | 21,330 |
See
accompanying notes to condensed consolidated financial
statements
3
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Statements of Operations
(in
thousands, except per share amounts)
(unaudited)
Three Months Ended
|
||||||||
March 31, 2010
|
March 31, 2009
|
|||||||
Net
sales (Note 2)
|
$ | 1,976 | $ | 3,987 | ||||
Cost
of sales (Note 2)
|
806 | 1,635 | ||||||
Gross
profit
|
1,170 | 2,352 | ||||||
Operating
costs and expenses:
|
||||||||
Sales
and marketing
|
734 | 2,024 | ||||||
Administration
|
1,412 | 2,290 | ||||||
Research
and development
|
88 | 248 | ||||||
2,234 | 4,562 | |||||||
Loss
from operations
|
(1,064 | ) | (2,210 | ) | ||||
Interest
and other income
|
2 | 11 | ||||||
Loss
before income taxes
|
(1,062 | ) | (2,199 | ) | ||||
Income
tax (Note 7)
|
- | - | ||||||
Net
loss
|
$ | (1,062 | ) | $ | (2,199 | ) | ||
Basic
earnings per share
|
||||||||
Loss
from continuing operations
|
$ | (0.08 | ) | $ | (0.17 | ) | ||
Net
loss
|
$ | (0.08 | ) | $ | (0.17 | ) | ||
Diluted
earnings per share
|
||||||||
Loss
from continuing operations
|
$ | (0.08 | ) | $ | (0.17 | ) | ||
Net
loss
|
$ | (0.08 | ) | $ | (0.17 | ) | ||
Weighted
average common shares outstanding
|
||||||||
Basic
|
13,183 | 12,908 | ||||||
Diluted
|
13,183 | 12,908 |
See
accompanying notes to condensed consolidated financial
statements
4
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Statements of
Stockholders’
Equity
(in
thousands, except share data)
(unaudited)
Additional
|
||||||||||||||||||||||||
Common Stock
|
Par
|
Paid-In
|
Retained
|
Treasury
|
||||||||||||||||||||
Shares
|
Value
|
Capital
|
Earnings
|
Stock
|
Total
|
|||||||||||||||||||
Balance
at December 31, 2009
|
13,033,383 | $ | 9 | $ | 37,726 | $ | 1,512 | $ | (25,188 | ) | $ | 14,059 | ||||||||||||
Net
loss
|
(1,062 | ) | (1,062 | ) | ||||||||||||||||||||
Proceeds
from exercise of stock options
|
15,000 | 19 | 19 | |||||||||||||||||||||
Common
stock issued to Phosphagenics
|
||||||||||||||||||||||||
Limited
pursuant to an Exclusive
|
||||||||||||||||||||||||
License
Agreement (Note 3)
|
1,440,000 | 1 | 2,576 | 2,577 | ||||||||||||||||||||
Common
stock granted pursuant to an employment agreement
|
11,004 | 23 | 23 | |||||||||||||||||||||
Tax
benefits from exercise of stock options
|
4 | 4 | ||||||||||||||||||||||
Tax
benefit allowance
|
(4 | ) | (4 | ) | ||||||||||||||||||||
Balance
at March 31, 2010
|
14,499,387 | $ | 10 | $ | 40,344 | $ | 450 | $ | (25,188 | ) | $ | 15,616 |
See
accompanying notes to condensed consolidated financial
statements
5
ProPhase
Labs, Inc. and Subsidiaries
Condensed
Consolidated Statements of Cash Flows
(in
thousands)
(unaudited)
Three Months Ended
|
||||||||
March 31, 2010
|
March 31, 2009
|
|||||||
Cash
Flows from operating activities:
|
||||||||
Net
loss
|
$ | (1,062 | ) | $ | (2,199 | ) | ||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activies:
|
||||||||
Depreciation
and amortization
|
82 | 157 | ||||||
Sales
discounts and provision for bad debts
|
(108 | ) | (49 | ) | ||||
Inventory
valuation provision
|
(638 | ) | (176 | ) | ||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
2,350 | 2,765 | ||||||
Inventory
|
909 | (69 | ) | |||||
Accounts
payable
|
(402 | ) | (403 | ) | ||||
Accrued
royalties and sales commissions
|
(152 | ) | (158 | ) | ||||
Accrued
advertising and other allowances
|
1 | (202 | ) | |||||
Other
operating assets and liabilities, net
|
97 | 692 | ||||||
Net
cash provided by operating activities
|
1,077 | 358 | ||||||
Cash
flows used in investing activities:
|
||||||||
Capital
expenditures
|
(45 | ) | (71 | ) | ||||
Cash
restricted for Phusion Laboratories, LLC.
|
(500 | ) | - | |||||
Acquisition
of product license
|
(1,000 | ) | - | |||||
Net
cash flows used in investing activities
|
(1,545 | ) | (71 | ) | ||||
Cash
flows from financing activities:
|
||||||||
Proceeds
from exercise of stock options
|
19 | - | ||||||
Net
cash provided by financing activities
|
19 | - | ||||||
Net
increase (decrease) in cash and cash equivalents
|
(449 | ) | 287 | |||||
Cash
and cash equivalents at beginning of period
|
12,801 | 11,957 | ||||||
Cash
and cash equivalents at end of period
|
$ | 12,352 | $ | 12,244 | ||||
Suplemental
disclosures of cash flow information:
|
||||||||
Interest
paid
|
$ | - | $ | - | ||||
Income
taxes paid
|
$ | 51 | $ | - | ||||
Common
stock issued to Phosphagenics Limited
|
||||||||
pursuant
to a product license agreement
|
$ | 2,577 | $ | - | ||||
Common
stock granted pursuant to an
|
||||||||
employment
agreement
|
$ | 23 | $ | - |
See
accompanying notes to condensed consolidated financial statements
6
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
1 – Organization and Business
ProPhase
Labs, Inc. (“we”, “us” or the “Company”), formerly known as The Quigley
Corporation, organized under the laws of the State of Nevada, is a manufacturer,
marketer and distributor of a diversified range of homeopathic and health
products that are offered to the general public. We are also engaged in the
research and development of potential natural base health products along with
supplements and cosmeceuticals for human and veterinary use.
Our
primary business is currently the manufacture, distribution, marketing and sale
of over-the-counter (“OTC”) cold remedy products to consumers through national
chain, regional, specialty and local retail stores. One of our
principal products is Cold-EEZEÒ,
a zinc gluconate glycine product proven in clinical studies to reduce the
duration and severity of the common cold symptoms by nearly
half. Cold-EEZEÒ
is an established product in the health care and cold remedy
market. For the three months ended March 31, 2010 and 2009, our
revenues from continuing operations have come principally from our cold remedy
products.
On May 5,
2010, our shareholders approved, among other corporate matters, the Board of
Directors’ proposal to change our name to ProPhase Labs, Inc. from The Quigley
Corporation. As a consequence, we amended the Company’s Articles of
Incorporation to change our name to ProPhase Labs, Inc. The amendment became
effective on May 6, 2010. Concurrent with our name change, effective
May 10, 2010, our shares began trading under the new NASDAQ ticker symbol:
PRPH. We previously traded under the symbol: QGLY.
We use a
December 31 year-end for financial reporting purposes. References
herein to the fiscal year ended December 31, 2010 shall be the term “Fiscal
2010” and references to other “Fiscal” years shall mean the year which ended on
December 31 of the year indicated. The term “we”, “us: or the “Company” as used
herein also refer, where appropriate, to the Company, together with its
subsidiaries unless the context otherwise requires.
Our
financial statements for the three months ended March 31, 2009 and the balance
sheet at December 31, 2009 have been reclassified to conform to our current
period ended March 31, 2010 presentation.
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation
The unaudited condensed consolidated
financial statements have been prepared in accordance with generally accepted
accounting principles for interim financial statements and within the rules of
the Securities and Exchange Commission applicable to interim financial
statements and therefore do not include all disclosures that might normally be
required for financial statements prepared in accordance with generally accepted
accounting principles. The accompanying unaudited condensed
consolidated financial statements have been prepared by management without audit
and should be read in conjunction with the our consolidated financial
statements, including the notes thereto, appearing in our Annual Report on Form
10-K for the year ended December 31, 2009. In the opinion of
management, all adjustments necessary for a fair presentation of the
consolidated financial position, consolidated results of operations and
consolidated cash flows, for the periods indicated, have been made. The results
of operations for the three months ended March 31, 2010 are not necessarily
indicative of operating results that may be achieved over the course of the full
year.
7
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Seasonality
of the Business
Our net
sales are derived principally from our cold remedy
products. Currently, our sales are influenced by and subject to
fluctuations in the timing of purchase and the ultimate level of demand for our
products which are a function of the timing, length and severity of each cold
season. Generally, a cold season is defined as the period of
September to March when the incidence of the common cold rises as a consequence
of the change in weather and other factors. We generally experience
in the fourth quarter higher levels of net sales along with a corresponding
increase in marketing and advertising expenditures designed to promote its
products during the cold season. Revenues and related marketing costs
are generally at their lowest levels in the second quarter when consumer demand
generally declines. We track health and wellness trends and develop
retail promotional strategies to align our production scheduling, inventory
management and marketing programs to optimize consumer purchases.
Use
of Estimates
The
preparation of financial statements and the accompanying notes thereto, in
conformity with generally accepted accounting principles, requires management to
make estimates and assumptions that affect our reported amounts of assets and
liabilities and our disclosure of contingent assets and liabilities at the date
of the financial statements and our reported amounts of revenues and expenses
during the respective reporting periods. Examples include the
provision for bad debt, sales returns and allowances, inventory obsolescence,
useful lives of property and equipment and intangible assets, impairment of
property and equipment and intangible assets, income tax valuations and
assumptions related to accrued advertising. These estimates and
assumptions are based on historical experience, current trends and other factors
that management believes to be relevant at the time the financial statements are
prepared. Management reviews the accounting policies, assumptions,
estimates and judgments on a quarterly basis. Actual results could
differ from those estimates.
Our primary product, Cold-EEZEÒ,
utilizes a proprietary zinc formulation which has been clinically proven to
reduce the severity and duration of common cold
symptoms. Accordingly, factors considered in estimating the
appropriate sales returns and allowances for this product include it being (i) a
unique product with limited competitors, (ii) competitively priced, (iii)
promoted, (iv) unaffected for remaining shelf-life as there is no product
expiration date, and (v) monitored for inventory levels at major customers and
third-party consumption data. We added new products to our OTC
Personal Care product line in Fiscal 2007 and Fiscal 2008 such as ISC-10 Immune
(subsequently discontinued in Fiscal 2009), Organix Organic Cough and Sore
Throat Drops and Kids-EEZEÒ
Chest Relief. Each of these new products do carry shelf-life
expiration dates for which we aggregate such new product market experience data
and updates our sales returns and allowances estimates
accordingly. Sales returns, allowances, cash discounts and
cooperative incentive promotion costs (“Sales Allowances”) estimates
are tracked at the specific customer and product line levels and are tested on
an annual historical basis, and reviewed quarterly. Additionally, the monitoring
of current occurrences, developments by customer, market conditions and any
other occurrences that could affect the expected provisions relative to net
sales for the period presented are also performed.
Cash
Equivalents
We
consider all highly liquid investments with an initial maturity of three months
or less at the time of purchase to be cash equivalents. Cash
equivalents include cash on hand and monies invested in money market funds. The
carrying amount approximates the fair market value due to the short-term
maturity of these investments. Our cash and money market balances are
classified as Level 1 instruments based upon fair value measurement hierarchy
which are valued based upon quoted market prices in active
markets.
8
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Inventory
Valuation
Inventory
is valued at the lower of cost, determined on a first-in, first-out basis
(“FIFO”), or market. Inventory items are analyzed to determine cost
and the market value and, if appropriate, inventory valuation reserves are
established. The condensed consolidated financial statements include
a specific reserve for excess or obsolete inventory of approximately $1.2
million and $1.8 million as of March 31, 2010 and December 31, 2009,
respectively. Raw material, work in progress and packaging inventory
aggregated approximately $652,000 and $610,000 at March 31, 2010 and December
31, 2009, respectively. Finished goods inventory was $482,000 and
$795,000 at March 31, 2010 and December 31, 2009, respectively.
Property,
Plant and Equipment
Property,
plant and equipment are recorded at cost. We use a combination of
straight-line and accelerated methods in computing depreciation for financial
reporting purposes. Depreciation expense is computed in accordance
with the following ranges of estimated asset lives: building and improvements -
twenty to thirty-nine years; machinery and equipment - five to seven years;
computer software - three years; and furniture and fixtures – seven
years.
Concentration
of Risks
Future
revenues, costs, margins, and profits will continue to be influenced by our
ability to maintain our manufacturing availability and capacity together with
our marketing and distribution capabilities and the requirements associated with
the development of OTC Personal Care products in order to continue to compete on
a national and/or international level.
Our
business is subject to federal and state laws and regulations adopted for the
health and safety of users of our products. Cold-EEZE® is a
homeopathic remedy that is subject to regulations by various federal, state and
local agencies, including the Food and Drug Administration (“FDA”) and the
Homeopathic Pharmacopoeia of the United States.
Financial
instruments that potentially subject us to significant concentrations of credit
risk consist principally of cash investments and trade accounts
receivable.
We
maintain cash and cash equivalents with several major financial institutions. As
of March 31, 2010, our cash balance was $12.8 million and bank balance was $13.2
million. Of the total bank balance, $7.9 million was covered by federal
depository insurance and $5.3 million was uninsured.
Trade
accounts receivable potentially subjects us to credit risk. We extend
credit to our customers based upon an evaluation of the customer’s financial
condition and credit history and generally we do not require
collateral. Our broad range of customers includes many large
wholesalers, mass merchandisers and multi-outlet pharmacy and chain drug store.
For the three months ended March 31, 2010 and 2009, all of our net sales were
related to domestic markets.
Our
revenues are principally generated from the sale of the cold remedy products
which approximated 94% and 84% of total revenues for the three months ended
March 31, 2010 and 2009, respectively. A significant portion of our
business is highly seasonal, which causes major variations in operating results
from quarter to quarter. The third and fourth quarters generally
represent the largest sales volume for the OTC cold remedy
products.
9
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Long-lived
Assets
We review our carrying value of its
long-lived assets with definite lives whenever events or changes in
circumstances indicate that the carrying amount of the assets may not be
recoverable. When indicators of impairment exist, we determine
whether the estimated undiscounted sum of the future cash flows of such assets
is less than their carrying amounts. If less, an impairment loss is
recognized in the amount, if any, by which the carrying amount of such assets
exceeds their respective fair values. The determination of fair value
is based on quoted market prices in active markets, if available, or independent
appraisals; sales price negotiations; or projected future cash flows discounted
at a rate determined by management to be commensurate with our business
risk. The estimation of fair value utilizing discounted forecasted
cash flows includes significant judgments regarding assumptions of revenue,
operating and marketing costs; selling and administrative expenses; interest
rates; property and equipment additions and retirements; industry competition;
and general economic and business conditions, among other factors.
In June
2009, we concluded the closing of our Elizabethtown manufacturing
facility. At March 31, 2010 and December 31, 2009, our reported
assets include Assets Held For
Sale aggregating $138,000 related to the land and buildings of the
Elizabethtown manufacturing facility. These assets have been recorded
at their estimated fair value, less estimated costs to sell.
As
codified under Accounting Standards Codification (“ASC”) ASC-820, “Fair Value Measurements and
Disclosure” (formerly Statement of Financial Accounting Standard (“SFAS”)
No. 157 “Fair Value
Measurements”) fair value is based on the prices that would be received
to sell an asset or paid to transfer a liability in an orderly transaction
between market participants at the measurement date. In order to increase
consistency and comparability in fair value measurements, ASC-820 establishes a
three-tier fair value hierarchy that prioritizes the inputs used to measure fair
value. These tiers include: Level 1, defined as observable inputs such as quoted
prices in active markets; Level 2, defined as inputs other than quoted prices in
active markets that are either directly or indirectly observable; and Level 3,
defined as unobservable inputs for which little or no market data exists,
therefore requiring an entity to develop its own assumptions.
The fair
value of the reported Assets
Held For Sale was arrived at through bids generated from interested third
party purchasers and guidance from a third party real estate advisor thereby
relating to Level 3 fair value hierarchy.
Fair
Value of Financial Instruments
Cash and
cash equivalents, accounts receivable and accounts payable are reflected in the
Condensed Consolidated Financial Statements at carrying value which approximates
fair value because of the short-term maturity of these
instruments. Determination of fair value of related party payables,
if any, is not practicable due to their related party nature.
Revenue
Recognition
Sales are
recognized at the time ownership is transferred to the
customer. Revenue is reduced for trade promotions, estimated sales
returns, cash discounts and other allowances in the same period as the related
sales are recorded. We make estimates of potential future product returns and
other allowances related to current period revenue. We analyze historical
returns, current trends, and changes in customer and consumer demand when
evaluating the adequacy of the sales returns and other
allowances.
10
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
We do not
impose a period of time within which product may be returned. All
requests for product returns must be submitted to us for
pre-approval. The main components of our returns policy are: (i) we
will accept returns that are due to damaged product that is un-saleable and such
return request activity fall within an acceptable range, (ii) we will accept
returns for products that have reached or exceeded designated expiration dates
and (iii) we will accept returns in the event that we discontinue a product
provided that the customer will have the right to return only such items that it
purchased directly from us. We will not accept return requests
pertaining to customer inventory “Overstocking” or “Resets”. We will
only accept return requests for product in its intended package
configuration. We reserve the right to terminate shipment of product
to customers who have made unauthorized deductions contrary to our return policy
or pursue other methods of reimbursement. We compensate the customer for
authorized returns by means of a credit applied to amounts owed or to be owed
and in the case of discontinued product only, also by way of an
exchange. We do not have any significant product exchange
history.
As of
March 31, 2010 and December 31, 2009, we included a provision for Sales
Allowances of $22,000 and $127,000 respectively for other allowances which is
reported as a reduction to account receivables. We also included an
estimate of the uncollectability of our accounts receivable as an allowance for
doubtful accounts of $22,000 and $23,000 as of March 31, 2010 and December 31,
2009, respectively. Additionally, accrued advertising and other
allowances as of March 31, 2010 include $1.5 million for future sales returns
and $609,000 for cooperative incentive promotion costs. As of December 31, 2009
accrued advertising and other allowances $1.5 million for future sales returns
and $586,000 for cooperative incentive promotion costs.
Shipping
and Handling
Product
sales carry shipping and handling charges to the purchaser, included as part of
the invoiced price, which is classified as revenue. In all cases
costs related to this revenue are recorded in cost of sales.
Stock
Compensation
We
recognize all share-based payments to employees, including grants of employee
stock options, as compensation expense in the financial statements based on
their fair values. Fair values of stock options are determined
through the use of the Black-Scholes option pricing model. The
compensation cost is recognized as an expense over the requisite service period
of the award, which usually coincides with the vesting period.
Stock
options and warrants for purchase of our common stock, $0.0005 par value
(“Common Stock”) have been granted to both employees and
non-employees. Options and warrants are exercisable during a period
determined by us, but in no event later than ten years from the date
granted. No stock options or warrants to purchase our Common Stock
have been granted for the three months ended March 31, 2010 and 2009,
respectively.
Variable
Interest Entity
ASC-810
establishes criterion and implementation guidance for the consolidation of
variable interest entities (“VIE”). As a consequence of the formation
of Phusion Laboratories LLC (“Phusion”), of which we own a 50%
membership interest effective March 22, 2010, Phusion qualifies as a variable
interest entity and we have consolidated Phusion beginning with the quarter
ended March 31, 2010 (see Note 3).
11
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
Advertising
and Incentive Promotions
Advertising
and incentive promotion costs are expensed within the period in which they are
utilized. Advertising and incentive promotion expense is comprised of media
advertising, presented as part of sales and marketing expense, cooperative
incentive promotions and coupon program expenses, which are accounted for as
part of net sales, and free product, which is accounted for as part of cost of
sales. Advertising and incentive promotion costs incurred for the
three months ended March 31, 2010 and 2009 were $863,000 and $2.2 million
respectively. Included in prepaid expenses and other current assets
was zero and $170,000 at March 31, 2010 and December 31, 2009, respectively,
relating to prepaid advertising and promotion expense.
Research
and Development
Research and development costs are
charged to operations in the period incurred. Research and development costs for
the three months ended March 31, 2010 and 2009 were $88,000 and $248,000,
respectively. Research and development costs are principally related to certain
study activities, costs associated with the development of potential new product
development initiatives and costs associated with Cold-EEZE®.
Income
Taxes
We
utilize the asset and liability approach which requires the recognition of
deferred tax assets and liabilities for the future tax consequences of events
that have been recognized in our financial statements or tax returns. In
estimating future tax consequences, we generally consider all expected future
events other than enactments of changes in the tax law or
rates. Until sufficient taxable income to offset the temporary timing
differences attributable to operations and the tax deductions attributable to
option, warrant and stock activities are assured, a valuation allowance equaling
the total net deferred tax assets is being provided (see Note 7).
We
utilize a two-step approach to recognizing and measuring uncertain tax
positions. The first step is to evaluate the tax position for
recognition by determining if the weight of available evidence indicates that it
is more likely than not that the position will be sustained on audit, including
resolution of related appeals or litigation processes, if any. The second step
is to measure the tax benefit as the largest amount which is more than fifty
percent likely of being realized upon ultimate settlement.
As a
result of our continuing tax losses, we have recorded a full valuation allowance
against the net deferred tax assets. Additionally, we have not
recorded a liability for unrecognized tax benefits. The tax years
2006-2009 remain open to examination by the major taxing jurisdictions to which
we are subject.
Recently
Issued Accounting Standards
In
November 2008, the SEC issued for comment a proposed roadmap regarding the
potential use by U.S. issuers of financial statements prepared in accordance
with International Financial Reporting Standards (“IFRS”). IFRS is a
comprehensive series of accounting standards published by the International
Accounting Standards Board (“IASB”). Under the proposed roadmap, we could be
required in fiscal 2014 to prepare financial statements in accordance with IFRS.
The SEC will make a determination in 2011 regarding the mandatory adoption of
IFRS. We are currently assessing the impact that this potential change would
have on our consolidated financial statements and we will continue to monitor
the development of the potential implementation of IFRS.
12
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
2 – Summary of Significant Accounting Policies - continued
In June
2009, the Financial Accounting Standards Board (“FASB”) modified the accounting
standard related to consolidation. This standard, as modified,
intends to improve financial reporting by enterprises involved with variable
interest entities. This standard, as modified, addresses the effects
on certain provisions relating to the Consolidation of Variable
Interest Entities, as a result of the elimination of the qualifying
special-purpose entity concept in the accounting standard related
to transfers and servicing, and constituent concerns about the
application of certain key provisions of this standard, including those in which
the accounting and disclosures under the standard do not always provide timely
and useful information about an enterprise’s involvement in a variable interest
entity. This standard, as modified, is effective as of the beginning
of each reporting entity’s first annual reporting period that begins after
November 15, 2009, for interim periods within that first annual reporting
period, and for interim and annual reporting periods thereafter. Earlier
application is prohibited. The adoption of the consolidation
standard, as modified, did not have a material effect on our consolidated
financial statements.
In
October 2009, the FASB issued Accounting Standards Update No. 2009-13,
"Multiple-Deliverable Revenue Arrangements" ("ASU No. 2009-13").
ASU No. 2009-13 amends guidance included within Accounting Standards
Codification ("ASC") Topic 605-25 to require an entity to
use an estimated selling price when vendor specific objective evidence or
acceptable third party evidence does not exist for any products or services
included in a multiple element arrangement. The arrangement consideration should
be allocated among the products and services based upon their relative selling
prices, thus eliminating the use of the residual method of allocation. ASU No.
2009-13 also requires expanded qualitative and quantitative disclosures
regarding significant judgments made and changes in applying this guidance. ASU
No. 2009-13 is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15,
2010. Early adoption and retrospective application are also
permitted. We are currently evaluating the impact of adopting the
provisions of ASU No. 2009-13.
Note
3 – Investment in Phusion Laboratories, LLC.
On March
22, 2010, the Company, Phosphagenics Ltd. (“PSI Parent”), an Australian
corporation, Phosphagenics Inc. (“PSI”), a Delaware corporation and subsidiary
of PSI Parent, and Phusion Laboratories, LLC (the “Joint Venture”), a Delaware
limited liability company, entered into a Limited Liability Company Agreement
(the “LLC Agreement”) of the Joint Venture and additional related agreements for
the purpose of developing and commercializing, for worldwide distribution and
sale, a wide range of non-prescription remedies using PSI Parent’s proprietary
patented TPM™ technology (“TPM”). TPM facilitates the delivery and
depth of penetration of active molecules in pharmaceutical, nutraceutical, and
other products.
In
connection with the LLC Agreement, PSI Parent granted to us, pursuant to the
terms of a License Agreement, dated March 22, 2010 (the “Original License
Agreement”), (i) an exclusive, royalty-free, world-wide (subject to certain
limitations), paid-up license to exploit OTC drugs (and certain other products)
that embody certain of PSI Parent’s TPM-related patents and related know-how
(collectively, the “PSI Technology”) and (ii) a non-exclusive, royalty-free,
world-wide (subject to certain limitations), paid-up license to exploit certain
compounds that embody the PSI Technology for use in a product combining one or
more of such compounds with an OTC drug or in a product that is part of a
regimen that includes the application of an OTC drug.
13
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
3 – Investment in Phusion Laboratories, LLC. – continued
Pursuant
to the Original License Agreement, we issued 1,440,000 shares of our Common
Stock having an aggregate value of approximately $2.6 million to PSI Parent
(such shares, the “PSI Shares”), and made a one-time payment to PSI Parent of
$1.0 million. PSI Parent has agreed, pursuant to a Share Transfer
Restriction Agreement, dated March 22, 2010 (the “Share Transfer Restriction
Agreement”), between us and PSI Parent, that, with certain exceptions, it will
not sell or otherwise dispose of any of the PSI Shares prior to June 1,
2012. The PSI Shares were issued pursuant to an exemption from
registration under the Securities Act, by virtue of Section 4(2) of the
Securities Act and by virtue of Rule 506 of Regulation D under the Securities
Act. Such sale and issuance did not involve any public offering and
was made without general solicitation or advertising. Additionally,
PSI Parent represented to us, among other things, that PSI Parent is not a US
Person (as defined in Regulation S under the Securities Act), that PSI Parent is
an accredited investor with access to all relevant information necessary to
evaluate its investment and that the PSI Shares were being acquired for
investment purposes only.
In
accordance with a Contribution Agreement, dated March 22, 2010 (the
“Contribution Agreement”), by and among us, PSI Parent, PSI, and the Joint
Venture, we transferred, conveyed and assigned to the Joint Venture all of our
rights, title and interest in, to and under the Original License Agreement, and
the Joint Venture assumed, and undertook to pay, discharge and perform when due,
all of our liabilities and obligations under and arising pursuant to the
Original License Agreement (such actions, collectively, the “Assignment and
Assumption”). Additionally, we agreed to contribute $500,000 to the
Joint Venture as part of our initial capital contribution.
Pursuant
to the Contribution Agreement and in order to reflect the Assignment and
Assumption, we, PSI Parent and the Joint Venture entered into an Amended and
Restated License Agreement, dated March 22, 2010 (the “Amended License
Agreement”), which amends and restates the Original License Agreement to reflect
that the Joint Venture is the licensee thereunder and which otherwise contains
substantially the same terms as the Original License Agreement. The
Joint Venture has the right to grant one or more sub-licenses of the rights
granted under the Amended License Agreement to one or more third parties for
reasonable consideration in any part of the applicable territory. The
Amended License Agreement provides that PSI Parent shall not, directly or
through third parties, exploit the covered intellectual property during the term
thereof, subject to certain limitations. The Amended License
Agreement will remain in effect until the expiration of the last to expire of
the patents included within the PSI Technology or any extensions
thereof. Either party may terminate the Amended License Agreement
upon written notice to the other party in the event of certain events involving
bankruptcy or insolvency. The Amended License Agreement also
contains, among other things, provisions concerning the treatment of
confidential information, the ownership of intellectual property and
indemnification obligations.
Pursuant
to the LLC Agreement, we and PSI each own a 50% membership interest in the Joint
Venture. PSI Parent will conduct and oversee much of the product
development, formulation, testing and other research and development needed by
the Joint Venture, and we will oversee much of the production, distribution,
sales and marketing. The LLC Agreement provides that each member may
be required, from time to time and subject to certain limitations, to make
capital contributions to the Joint Venture to fund its operations, in accordance
with agreed upon budgets for products to be developed. Specifically
we agreed to contribute $500,000 of initial capital and are committed to fund up
to $2.0 million, subject to agreed upon budgets (which have not yet been
established), toward the initial development and marketing costs of new products
for the Joint Venture. At March 31, 2010, we have segregated $500,000
of our available cash balances as restricted cash as a consequence of our
minimum contribution obligation to the Joint Venture.
14
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
3 – Investment in Phusion Laboratories, LLC. – continued
The Joint
Venture is managed by a four-person Board of Managers, with two managers
appointed by each member. The initial Board of Managers is comprised
of four representatives, two representatives from each of the Company and PSI
Parent. The initial Company representatives on the Board of Managers
are Mr. Karkus and Mr. Cuddihy. Mr. Karkus, on our behalf, and Mr.
Harry Rosen, on behalf of PSI, are the Co-Chief Executive Officers of the Joint
Venture. The LLC Agreement contains other normally found terms in
such arrangements, including provisions relating to governance of the Joint
Venture, indemnification obligations of the Joint Venture, allocation of profits
and losses, the distribution of funds to the members and restrictions on
transfer of a member’s interest.
Our
initial determination is that the Joint Venture qualifies as a variable interest
entity during the pre-commercialization, product development period based upon
(i) our expected level of capital at risk, (ii) the level of our significant
control of the product development initiatives and (iii) our early stage
allocation to realize gains and losses of the Joint Venture. As a consequence,
we have consolidated the Joint Venture financial statements beginning with the
quarter ended March 31, 2010. For the three months ended March 31,
2010, the newly formed Joint Venture has not engaged in any financial
transactions as formal operations are not expected to commence until the second
or third quarter of Fiscal 2010. At March 31, 2010, PSI Parent has no
capital contribution in the Joint Venture therefore no amount is allocated to
“non-controlling interest” in our financial statements. Additionally,
at March 31, 2010 we have recorded the $3.6 million payment representing the
preliminary, estimated fair value to acquire the product license as an
intangible asset. We currently estimate the expected useful
life of the product license to be approximately 12 years. We
will begin amortizing the cost of intangible asset once product
commercialization is completed with PSI Parent and the OTC drug products begin
to ship to our retail customers. As of March 31, 2010, we have not
established a formal commercialization program timeline for any specific OTC
drug covered under the product license but we do not project that any OTC drug
products will be available for shipment within the next twelve
months.
Note
4 – Other Current Liabilities
At March
31, 2010 and December 31, 2009, included in other current liabilities are
accrued compensation of $407,000 and $386,000, respectively.
Note
5 – Commitments and Contingencies
We have
maintained a separate representation and distribution agreement relating to the
development of the zinc gluconate glycine product formulation. In
return for exclusive distribution rights, we agreed to pay the developer a 3%
royalty and a 2% consulting fee based on sales collected, less certain
deductions, throughout the term of this agreement, which expired in May
2007. However, we and the developer are in litigation and as such no
potential offset from such litigation for these fees have been
recorded.
In July
2008, we entered into an agreement with a vendor to purchase a minimum order of
product, initially over a three year period, incorporating a patented,
proprietary delivery system. This agreement was amended, first in
July 2009 and further amended in February 2010 resulting in, but not limited to,
(i) a reduction in the (a) term of agreement and (b) purchase commitment, and
(ii) reformulation of the flavor of the product. In addition, a new
agreement was entered into in February of 2010 for the development of two new
products. The aggregate purchase commitment under the term of these
agreements, as amended, was $660,000 at March 31, 2010.
15
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
5 – Commitments and Contingencies – continued
Certain
operating leases for office and warehouse space maintained by us resulted in
rent expense for the three month periods ended March 31, 2010 and 2009 of zero
and $18,000, respectively. We have estimated future obligations over the next
five years, including the remainder of Fiscal 2010, as follows (in
thousands):
Fiscal
Year
|
Employment
Contracts
|
Advertising
|
Product
Purchases
|
Phusion Product
Development
|
Total
|
|||||||||||||||
2010
|
$ | 806 | $ | 235 | $ | 660 | $ | 500 | $ | 2,201 | ||||||||||
2011
|
1,075 | - | - | - | 1,075 | |||||||||||||||
2012
|
582 | - | - | - | 582 | |||||||||||||||
2013
|
- | - | - | - | - | |||||||||||||||
2014
|
- | - | - | - | - | |||||||||||||||
Total
|
$ | 2,463 | $ | 235 | $ | 660 | $ | 500 | $ | 3,858 |
Additional
research and development and advertising costs are expected to be incurred
during the remainder of Fiscal 2010.
Note
6 – Transactions Affecting Stockholders’ Equity
Stockholder
Rights Plan
On
September 8, 1998, our Board of Directors declared a dividend distribution of
Common Stock Purchase Rights (each individually, a “Right” and collectively, the
“Rights”) payable to the stockholders of record on September 25, 1998, thereby
creating a Stockholder Rights Plan (the “Rights Agreement”). The Plan
was amended effective May 23, 2008 (“First Amendment”) and further amended
effective August 18, 2009 (“Second Amendment”). The Rights Agreement,
as amended, provides that each Right entitles the stockholder of record to
purchase from the Company that number of common shares having a combined market
value equal to two times the Rights exercise price of $45. The Rights
are not exercisable until the distribution date, which will be the earlier of a
public announcement that a person or group of affiliated or associated persons
has acquired 15% or more of the outstanding common shares, or the announcement
of an intention by a similarly constituted party to make a tender or exchange
offer resulting in the ownership of 15% or more of the outstanding common
shares. The dividend has the effect of giving the stockholder a 50%
discount on the share’s current market value for exercising such
right. In the event of a cashless exercise of the Right, and the
acquirer has acquired less than 50% beneficial ownership of the Company, a
stockholder may exchange one Right for one common share of the
Company. The Rights Agreement, as amended, includes a provision
pursuant to which our Board of Directors may exempt from the provisions of the
Rights Agreement an offer for all outstanding shares of our Common Stock that
the directors determine to be fair and not inadequate and to otherwise be in the
best interests of the Company and its stockholders, after receiving advice from
one or more investment banking firms. The expiration date of the Rights
Agreement, as amended, is September 25, 2018.
Stock
Option Exercise
For the
three months ended March 31, 2010, we derived net proceeds of $19,000 as a
consequence of the exercise of options to acquire 15,000 shares of our Common
Stock. During the three months ended March 31, 2009, no options were
exercised.
16
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
7 – Income Taxes
We
utilize the asset and liability approach which requires the recognition of
deferred tax assets and liabilities for the future tax consequences of events
that have been recognized in our financial statements or tax returns. In
estimating future tax consequences, we generally consider all expected future
events other than enactments of changes in the tax law or
rates. Until sufficient taxable income to offset the temporary timing
differences attributable to operations and the tax deductions attributable to
option, warrant and stock activities are assured, a valuation allowance equaling
the total deferred tax asset is being provided.
We
utilize a two-step approach to recognizing and measuring uncertain tax
positions. The first step is to evaluate the tax position for
recognition by determining if the weight of available evidence indicates that it
is more likely than not that the position will be sustained on audit, including
resolution of related appeals or litigation processes, if any. The second step
is to measure the tax benefit as the largest amount which is more than fifty
percent likely of being realized upon ultimate settlement.
Certain
exercises of options and warrants, and restricted stock issued for services that
became unrestricted resulted in reductions to taxes currently payable and a
corresponding increase to additional-paid-in-capital for prior
years. In addition, certain tax benefits for option and warrant
exercises totaling $6.9 million are deferred and will be credited to
additional-paid-in-capital when our net operating loss carryforwards
attributable to these exercises are utilized. Consequently, these net
operating loss carryforwards will not be available to offset our current income
tax expense. As of December 31, 2009, we had net operating loss
carry-forwards of approximately $25.7 million for federal purposes that will
expire through 2029. Additionally, there are net operating loss
carry-forwards of $20.3 million for state purposes that will expire through
2029. Until sufficient taxable income to offset the temporary timing
differences attributable to operations, the tax deductions attributable to
option, warrant and stock activities and alternative minimum tax credits of
$26,000 are assured, we have recorded a full valuation allowance equaling the
total deferred tax asset at March 31, 2010 and December 31, 2009. As
of March 31, 2010 and December 31, 2009, we have no unrecognized tax
benefits.
The
major jurisdiction for which we file income tax returns is the United
States. The Internal Revenue Service (“IRS”) has examined our tax
year ended September 30, 2005 and has made no changes to the filed tax
returns. The tax years 2006 and forward remain open to examination by
the IRS. The tax years 2004 and forward remain open to examination by
the various state taxing authorities to which we are subject.
Effective
December 31, 2009, we elected to conform our tax reporting year, historically a
fiscal period ending September 30, to our financial reporting period ending
December 31. As a consequence, we filed a full period tax return for
the fiscal year ended September 30, 2009 with the IRS and will also file with
the IRS a “short period return” for the three months ended December 31, 2009 in
compliance with the election. In future fiscal periods, our tax and
financial reporting periods will be the same, the period ending December
31.
Note
8 – Earnings (Loss) Per Share
Basic
earnings per share is computed by dividing net income or loss to common
stockholders by the weighted-average number of shares of our common stock
outstanding for the period. Diluted earnings per share reflects the
potential dilution that could occur if securities or other contracts to issue
Common Stock were exercised or converted into Common Stock or resulted in the
issuance of Common Stock that shared in the earnings of the
entity. Diluted earnings per share also utilizes the treasury stock
method which prescribes a theoretical buy-back of shares from the theoretical
proceeds of all options and warrants outstanding during the
period. Options and warrants outstanding at March 31, 2010 and 2009
were 1,449,750 and 2,113,750, respectively.
17
ProPhase
Labs, Inc. and Subsidiaries
Notes to
Condensed Consolidated Financial Statements
(unaudited)
Note
8 – Earnings (Loss) Per Share – continued
For the
three months ended March 31, 2010 and 2009, dilutive earnings per share is the
same as basic earnings per share due to (i) the inclusion of Common Stock, in
the form of stock options and warrants (“Common Stock Equivalents”), would have
an anti-dilutive effect on the loss per share or (ii) there were no Common
Stock Equivalents for the respective period. For the three months
ended March 31, 2010 and 2009, there were 86,000 and 239,767 Common Stock
Equivalents, respectively, which were in the money, that were excluded in the
earnings per share computation.
A
reconciliation of the applicable numerators and denominators of the income
statement periods presented, as reflected in the results of continuing
operations, is as follows (in thousands, except per share amounts):
Three
Months Ended
|
||||||||||||||||||||||||
March
31, 2010
|
March
31, 2009
|
|||||||||||||||||||||||
Income
|
Shares
|
EPS
|
Income
|
Shares
|
EPS
|
|||||||||||||||||||
Basic
loss per share
|
$ | (1.1 | ) | 13.2 | $ | (0.08 | ) | $ | (2.2 | ) | 12.9 | $ | (0.17 | ) | ||||||||||
Dilutives:
|
||||||||||||||||||||||||
Options/Warrants
|
- | - | - | - | - | - | ||||||||||||||||||
Diluted
loss per share
|
$ | (1.1 | ) | 13.2 | $ | (0.08 | ) | $ | (2.2 | ) | 12.9 | $ | (0.17 | ) |
18
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Item
2.
General
ProPhase
Labs, Inc. (“we”, “us” or the “Company”), formerly known as The Quigley
Corporation, organized under the laws of the State of Nevada, is a manufacturer,
marketer and distributor of a diversified range of homeopathic and health
products that are offered to the general public. We are also engaged in the
research and development of potential natural base health products along with
supplements and cosmeceuticals for human and veterinary use.
Our
primary business is currently the manufacture, distribution, marketing and sale
of over-the-counter (“OTC”) cold remedy products to consumers through national
chain, regional, specialty and local retail stores. One of our
principal products is Cold-EEZEÒ,
a zinc gluconate glycine product proven in clinical studies to reduce the
duration and severity of the common cold symptoms by nearly
half. Cold-EEZEÒ
is an established product in the health care and cold remedy
market. For the three months ended March 31, 2010 and 2009, our
revenues from continuing operations have come principally from our cold remedy
products.
On May 5,
2010, our shareholders approved, among other corporate matters, the Board of
Directors’ proposal to change our name to ProPhase Labs, Inc. from The Quigley
Corporation. As a consequence, we amended the Company’s Articles of
Incorporation to change our name to ProPhase Labs, Inc. The amendment became
effective on May 6, 2010. Concurrent with our name change, effective
May 10, 2010, our shares began trading under the new NASDAQ ticker symbol: PRPH.
The Company previously traded under the symbol: QGLY.
Recent
Developments
Joint Venture – Phusion
Laboratories, LLC
On March
22, 2010, the Company, Phosphagenics Limited (“PSI Parent”), an Australian
corporation, Phosphagenics Inc. (“PSI”), a Delaware corporation and subsidiary
of PSI Parent, and Phusion Laboratories, LLC (the “Joint Venture”), a Delaware
limited liability company, entered into a Limited Liability Company Agreement
(the “LLC Agreement”) of the Joint Venture and additional related agreements for
the purpose of developing and commercializing, for worldwide distribution and
sale, a wide range of non-prescription remedies using PSI Parent’s proprietary
patented TPM™ technology (“TPM”). TPM facilitates the delivery and
depth of penetration of active molecules in pharmaceutical, nutraceutical, and
other products. Pursuant to the LLC Agreement, we and PSI each own a 50%
membership interest in the Joint Venture.
In
connection with the LLC Agreement, PSI Parent granted to us, pursuant to the
terms of a License Agreement, dated March 22, 2010 (the “Original License
Agreement”), (i) an exclusive, royalty-free, world-wide (subject to certain
limitations), paid-up license to exploit OTC drugs (and certain other products)
that embody certain of PSI Parent’s TPM-related patents and related know-how
(collectively, the “PSI Technology”) and (ii) a non-exclusive, royalty-free,
world-wide (subject to certain limitations) paid-up license to exploit certain
compounds that embody the PSI Technology for use in a product combining one or
more of such compounds with an OTC drug or in a product that is part of a
regimen that includes the application of an OTC drug.
Pursuant
to the Original License Agreement, we issued 1,440,000 shares of our Common
Stock having an aggregate value of approximately $2.6 million to PSI Parent
(such shares, the “PSI Shares”), and made a one-time payment to PSI Parent of
$1.0 million. In accordance with a Contribution Agreement, dated
March 22, 2010 (the “Contribution Agreement”), by and among us, PSI Parent, PSI,
and the Joint Venture, we transferred, conveyed and assigned to the Joint
Venture all of our rights, title and interest in, to and under the Original
License Agreement, and the Joint Venture assumed, and undertook to pay,
discharge and perform when due, all of our liabilities and obligations under and
arising pursuant to the Original License Agreement (such actions, collectively,
the “Assignment and Assumption”). Additionally, we agreed to
contribute $500,000 to the Joint Venture as part of our initial capital
contribution.
19
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
PSI
Parent will conduct and oversee much of the product development, formulation,
testing and other research and development needed by the Joint Venture, and we
will oversee much of the production, distribution, sales and
marketing. The LLC Agreement provides that each member may be
required, from time to time and subject to certain limitations, to make capital
contributions to the Joint Venture to fund its operations, in accordance with
agreed upon budgets for products to be developed. Specifically we
agreed to contribute $500,000 of initial capital and are committed to fund up to
$2.0 million, subject to agreed upon budgets (which have not yet been
established), toward the initial development and marketing costs of new products
for the Joint Venture. As of March 31, 2010, we have not established
a formal commercialization program timeline for any specific OTC drug covered
under the product license and we do not project that any OTC drug products will
be available for shipment within the next twelve months. At March 31,
2010, we have segregated $500,000 of our available cash balances as restricted
cash as a consequence of our minimum contribution obligation to the Joint
Venture.
Certain
Risk Factors
Our
business is regulated by various agencies of the states and localities where our
products are sold. Governmental regulations in foreign countries
where we plan to commence or expand sales may prevent or delay entry into a
market or prevent or delay the introduction, or require the reformulation of
certain of our products. In addition, no prediction can be made as to
whether new domestic or foreign legislation regulating our activities will be
enacted. Any new legislation could have a material adverse effect on
our business, financial condition and operations. Non-compliance with
any applicable requirements may subject us or the manufacturers of our products
to agency action, including warning letters, fines, product recalls, seizures
and injunctions.
The
manufacturing, processing, formulation, packaging, labeling and advertising of
our cold remedy products are subject to regulation by several federal agencies,
including (i) the FDA, (ii) the Federal Trade Commission (“FTC”), (iii) the
Consumer Product Safety Commission, (iv) the United States Department of
Agriculture, (v) the United States Postal Service, (vi) the United States
Environmental Protection Agency and (vii) the United States Occupational Safety
and Health Administration.
In
addition to OTC and prescription drug products, the FDA regulates the safety,
manufacturing, labeling and distribution of dietary supplements, including
vitamins, minerals and herbs, food additives, food supplements, over-the-counter
and prescription drugs and cosmetics. The FTC also has overlapping
jurisdiction with the FDA to regulate the promotion and advertising of vitamins,
over-the-counter drugs, cosmetics and foods. In addition, our cold
remedy products are homeopathic remedies which are subject to standards
established by the Homeopathic Pharmacopoeia of the United States
(“HPUS”). HPUS sets the standards for source, composition and
preparation of homeopathic remedies which are officially recognized under the
Federal Food, Drug and Cosmetics Act, as amended.
Preclinical
development, clinical trials, product manufacturing, labeling, distribution and
marketing of potential new products are also subject to federal and state
regulation in the United States and other countries. Clinical trials
and product marketing and manufacturing are subject to the rigorous review and
approval processes of the FDA and foreign regulatory authorities. To obtain
approval of a new drug product, a company must demonstrate through adequate and
well-controlled clinical trials that the drug product is safe and effective for
its intended use. Obtaining FDA and other required regulatory
approvals is lengthy and expensive. Typically, obtaining regulatory
approval for pharmaceutical products requires substantial resources and takes
several years. The length of this process depends on the type,
complexity and novelty of the product and the nature of the disease or other
indication to be treated. Preclinical studies must comply with FDA
regulations. Clinical trials must also comply with FDA regulations to
ensure safety of the human subjects in the trial and may require large numbers
of test subjects, complex protocols and possibly lengthy follow-up
periods. Consequently, satisfaction of government regulations may
take several years, may cause delays in introducing potential new products for
considerable periods of time and may require imposing costly procedures upon our
activities. If regulatory approval of new products is not obtained in
a timely manner or not at all, we could be materially adversely
affected. Even if regulatory approval of new products is obtained,
such approval may impose limitations on the indicated uses for which the
products may be marketed which could also materially adversely affect our
business, financial condition and future operations.
20
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Future
revenues, costs, margins, and profits will continue to be influenced by our
ability to maintain our manufacturing availability and capacity together with
our marketing and distribution capability and the requirements associated with
the development of potential OTC drug and other medicinal products in order to
continue to compete on a national and international level. Our
business development is dependent on continued conformity with government
regulations, a reliable information technology system capable of supporting
continued growth and continued reliable sources for product and materials to
satisfy consumer demand.
Readers
should carefully review the risk factors described in other sections of this
Report as well as in other documents we file from time to time with the
Securities and Exchange Commission.
Critical Accounting
Policies
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States (“GAAP”) requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent liabilities at the dates of the
financial statements and the reported amounts of revenues and expenses during
the reporting periods. Actual results could differ from those
estimates. Our significant accounting policies are described in Note
2 of Notes to Condensed Consolidated Financial Statements included under Item 1
of this Part I. However, certain accounting policies are deemed
“critical”, as they require management’s highest degree of judgment, estimates
and assumptions. These accounting estimates and disclosures have been
discussed with Audit Committee of our Board of Directors. A
discussion of our critical accounting policies, the judgments and uncertainties
affecting their application and the likelihood that materially different amounts
would be reported under different conditions or using different assumptions are
as follows:
Revenue Recognition – Sales
Allowances
When
providing for the appropriate sales returns, allowances, cash discounts and
cooperative incentive promotion costs (“Sales Allowances”), we apply a uniform
and consistent method for making certain assumptions for estimating these
provisions. These estimates and assumptions are based on historical
experience, current trends and other factors that management believes to be
relevant at the time the financial statements are
prepared. Management reviews the accounting policies, assumptions,
estimates and judgments on a quarterly basis. Actual results could
differ from those estimates.
Our
primary product, Cold-EEZEÒ,
has been clinically proven to reduce the severity and duration of common cold
symptoms. Accordingly, factors considered in estimating the
appropriate sales returns and allowances for this product include it being (i) a
unique product with limited competitors, (ii) competitively priced, (iii)
promoted, (iv) unaffected for remaining shelf-life as there is no product
expiration date, and (v) monitored for inventory levels at major customers and
third-party consumption data. We added new products to our OTC
Personal Care product line in Fiscal 2007 and Fiscal 2008 such as ISC-10 Immune
(discontinued in Fiscal 2009), Organix Organic Cough and Sore Throat Drops and
Kids-EEZEÒ
Chest Relief. Each of these new products do carry shelf-life
expiration dates for which we aggregate such new product market experience data
and update our sales returns and allowances estimates
accordingly. Sales Allowances estimates are tracked at the specific
customer and product line levels and are tested on an annual historical basis,
and reviewed quarterly. Additionally, the monitoring of current occurrences,
developments by customer, market conditions and any other occurrences that could
affect the expected provisions relative to net sales for the period presented
are also performed.
21
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
We do not
impose a period of time within which product may be returned. All
requests for product returns must be submitted to us for
pre-approval. The main components of our returns policy are: (i) we
will accept returns that are due to damaged product that is un-saleable and such
return request activity fall within an acceptable range, (ii) we will accept
returns for products that have reached or exceeded designated expiration dates
and (iii) we will accept returns in the event that we discontinue a product
provided that the customer will have the right to return only such item that it
purchased directly from us. We will not accept return requests
pertaining to customer inventory “Overstocking” or “Resets”. We
will only accept return requests for product in its intended package
configuration. We reserve the right to terminate shipment of product
to customers who have made unauthorized deductions contrary to our return policy
or pursue other methods of reimbursement. We compensate the customer for
authorized returns by means of a credit applied to amounts owed or to be owed
and in the case of discontinued product only, also by way of an
exchange. We do not have any significant product exchange
history.
We
classify product returns into principally three categories, (i) non-routine
returns, (ii) obsolete product and (iii) product mix realignment by certain of
our customers. “Non-routine” returns are defined as product returned
to us as a consequence of unanticipated circumstances principally due to (i)
retail store closings or (ii) unexpected poor retail sell through to consumers
causing us to discontinue the product. “Obsolete” returns are defined
as product returned to us as a consequence of product shelf-life “use by”
expiration date. “Product mix realignment”
returns are defined as product returned to us due to initiatives by the trade to
discontinue purchasing certain of our products. Product mix
realignment returns are generally nominal and are frequently related to
discontinued or soon to be discontinued products.
Our
return policy accommodates returns for (i) discontinued products, (ii) store
closings and (iii) products that have reached or exceeded designated expiration
date. As of March 31, 2010 and December 31, 2009, we included a provision for
Sales Allowances of $22,000 and $127,000 respectively for other allowances which
is reported as a reduction to account receivables. Additionally,
accrued advertising and other allowances as of March 31, 2010 include $1.5
million for future sales returns and $609,000 for cooperative incentive
promotion costs. As of December 31, 2009 accrued advertising and other
allowances included $1.5 million for future sales returns and $586,000 for
cooperative incentive promotion costs. We also included an estimate of the
uncollectability of our accounts receivable as an allowance for doubtful
accounts of $22,000 and $23,000 as of March 31, 2010 and December 31, 2009,
respectively.
A one
percent deviation for these Sales Allowance provisions for the three months
ended March 31, 2010, and 2009 would affect net sales by approximately $25,000
and $53,000, respectively.
Income
Taxes
As of
December 31, 2009, we have net operating loss carry-forwards of approximately
$25.7 million for federal purposes that will expire beginning in fiscal 2020
through 2029. Additionally, there are net operating loss
carry-forwards of $20.3 million for state purposes that will expire beginning in
fiscal 2018 through 2029. Until sufficient taxable income to offset
the temporary timing differences attributable to operations, the tax deductions
attributable to option, warrant and stock activities and alternative minimum tax
credits of $26,000 are assured, a valuation allowance equaling the total net
deferred tax assets is being provided. Management believes that this
allowance is required due to the uncertainty of realizing these tax benefits in
the future. The uncertainty arises largely due to substantial
historical losses.
22
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Seasonality
of the Business
Our net
sales are derived principally from our cold remedy
products. Currently, our sales are influenced by and subject to
fluctuations in the timing of purchase and the ultimate level of demand for its
products which are a function of the timing, length and severity of each cold
season. Generally, a cold season is defined as the period of
September to March when the incidence of the common cold rises as a consequence
of the change in weather and other factors. We generally experiences
in the fourth quarter higher levels of net sales along with a corresponding
increase in marketing and advertising expenditures designed to promote its
products during the cold season. Revenues and related marketing costs are
generally at its lowest levels in the second quarter when consumer demand
generally declines. We track health and wellness trends and develop
retail promotional strategies to align its production scheduling, inventory
management and marketing programs to optimize consumer purchases.
Financial
Condition and Results of Operations
Results
from Operations for the Three months Ended March 31, 2010
as
Compared to the Three Months Ended March 31, 2009
For the
three months ended March 31, 2010, net sales were $2.0 million as compared to
$4.0 million for the three months ended March 31, 2009. For the
three months ended March 31, 2010, net sales of cold remedy products were $1.9
million as compared to net sales of $3.3 million for three months ended March
31, 2009. For the three months ended March 31, 2010 and 2009, the
contract manufacturing generated net sales to third party customers of $116,000
and $654,000, respectively.
Net sales
of cold remedy products decline of $1.4 million for the three months ended March
31, 2010 as compared to the three months ended March 31, 2009 due principally to
an acceleration of our retail customer purchases and stocking for the 2009-2010
cold season into the fourth quarter of Fiscal 2009 skewing net sales for the
cold season. Net sales increased $314,000 to $11.1 million for the
six month period ended March 31, 2010 (the “2009-2010 Cold Season”) as compared
to $10.8 million the six month period ended March 31, 2009 (the “2008-2009 Cold
Season”). Data suggests that the highest incidence of upper
respiratory disorders for 2009-2010 Cold Season occurred in the fourth quarter
of Fiscal 2009 while the 2008-2009 Cold Season realized its concentration of
incidences in the first quarter of Fiscal 2009. Our flagship product,
Cold-EEZE®
continues to compete for market share with new products entering the category
and many retailer initiatives to reduce the number of products it carries on
shelf within the cold and flu remedy category. We are continuing to
support Cold-EEZE® as a
clinically proven cold remedy product through in-store promotion, media
advertising and coupon programs.
The
contract manufacturing product net sales decline of $538,000 for the three
months ended March 31, 2010 as compared to March 31, 2009 is due principally to
(i) the decline in candy product sales as a consequence of the closure of the
Elizabethtown manufacturing facility and (ii) fluctuations in contract
manufacturing orders from non-related third party entities to produce
lozenge-based products.
Cost of
sales for the three months ended March 31, 2010 were $806,000 as compared to
$1.6 million for the three months ended March 31, 2009. Although our
production volumes declined during the three months ended March 31, 2010 as
compared to the three months ended March 31, 2009, we realized a gross margin of
59.2% and 59.0%, respectively. Our gross margin reflects the
net effect of (i) the elimination of the production and facility overhead
expenses attributable to the closing of the Elizabethtown manufacturing
facility, (ii) improved production margins of the cold remedy products, offset
by (iii) an adverse impact of a reduction to net sales to absorb fixed
production overhead expenses at our manufacturing
facility. Gross margins are influenced by fluctuations in
quarter-to-quarter production volume, fixed production costs and related
overhead absorption, and the timing of shipments to customers which are factors
of the seasonality of our sales activities and products.
23
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Sales and
marketing expense for the three months ended March 31, 2010 decreased $1.3
million to $734,000, as compared to $2.0 million for the three months ended
March 31, 2009. The decrease in sales and marketing expense for the three months
ended March 31, 2010 as compared to the three months ended March 31, 2009 was
principally due to the net effects of (i) the implementation of more
cost effective and targeted marketing programs, (ii) improved timing of
marketing campaigns to better match the timing and product demand of the
2009-2010 Cold Season, (iii) improved in-store marketing and communications
programs and (iv) the discontinuation of certain ineffective marketing
programs.
General
and administration expense for the three months ended March 31, 2010 decreased
$878,000 to $1.4 million as compared to $2.3 million for the three months ended
March 31, 2009. The decrease in general and administration expense
for the three months ended March 31, 2010 as compared to the three months ended
March 31, 2009 was principally due to a decrease in personnel costs as a
consequence of a decrease in executive salaries, bonuses and head
count.
Research
and development costs during the three months ended March 31, 2010 decreased
$160,000 to $88,000 as compared to $248,000 for the three months ended March 31,
2009. The decrease of $160,000 in research and development costs for
the three months ended March 31, 2010 period as compared to the three months
ended March 31, 2009 was due to a decline in the scope, timing and amount of
research and development activity from period to period. In Fiscal
2009 and as a result of a strategic review, we determined to curtail further
investment in certain of our wholly owned subsidiary’s, Quigley
Pharma, Inc. (“Pharma”), existing products under development in light of our
view concerning market opportunities, regulatory pathways, the need for further
robust and consistent preclinical and clinical testing and continued
requirements in the areas of commercial formulation and development. However, we
continue to engage in research and development activities that we determine are
appropriate and will increase our research and development activities in future
periods as a consequence of the Joint Venture.
Interest
and other income for the three months ended March 31, 2010 was $2,000 as
compared to $11,000 for the three months ended March 31, 2009. The
decrease of $9,000 for the three months ended March 31, 2010 as compared to the
three months ended March 31, 2009 was due to the decrease in deposit
interest rates and a reduction in invested cash balances.
As a
consequence of the effects of the above, the net loss for the three months ended
March 31, 2010, was $1.1 million, or $0.08 per share, as compared to a net loss
of $2.2 million, or $0.17 per share, for the three months ended March 31,
2009.
Liquidity
and Capital Resources
The
aggregate unrestricted cash and cash equivalents as of March 31, 2010 were $12.4
million compared to $12.8 million at December 31, 2009. Our working
capital was $9.5 million and $11.5 million as of March 31, 2010 and December 31,
2009, respectively. Changes in
working capital for the three months ended March 31, 2010
were primarily due to (i) cash
provided by operations of $1.1 million, (ii) net proceeds of $19,000 realized
from the exercise of stock options, offset by (iii) capital expenditures of
$45,000, (iv) the cash payment to acquire the product license of $1.0 million
and (v) the financial commitment to the Joint Venture of $500,000 recorded as
restricted cash. Significant factors impacting working capital for
the three months ended March 31, 2010 included (i) a decrease in accounts
receivable balances and (ii) a decrease in other operating assets and
liabilities, each reflective of seasonal factors.
24
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Management
believes that its strategy to maintain Cold-EEZEÒ
as a recognized brand name, its broader range of products, its adequate
manufacturing capacity, together with its current working capital, should
provide an internal source of capital to fund normal business
operations. Our operations support the current research and
development expenditures related to new products. In addition to the
funding from operations, we may in the short and long term raise capital through
the issuance of securities or secure other financing sources to support such
product development research, new product acquisitions or a venture investment
or acquisition. Such funding through the issuance of equity
securities would result in the dilution of current stockholders’ ownership in
the Company. Should our product development initiatives progress on
certain formulations, additional development expenditures may require
substantial financial support and may necessitate the consideration of
alternative approaches such as licensing, joint venture, or partnership
arrangements that we determine will meet our long term goals and
objectives. Ultimately, should internal working capital be
insufficient and external funding methods or other business arrangements become
unattainable, it would likely result in the deferral or abandonment of future
development relative to current and prospective product development initiatives
and formulations.
Management
is not aware of any trends, events or uncertainties that have or are reasonably
likely to have a material negative impact upon our (i) short-term or long-term
liquidity, or (ii) net sales or income from continuing
operations. Any challenge to our patent rights could have a material
adverse effect on our future; however, we are not aware of any condition that
would make such an event probable. Our business is subject to
seasonal variations thereby impacting liquidity and working capital during the
course of our fiscal year.
Management
believes that cash generated from operations, along with its current cash
balances, will be sufficient to finance working capital and capital expenditure
requirements for at least the next twelve months. However, in the
longer term, we may require additional capital to support, among other items,
(i) new product introductions, (ii) expansion of our product marketing and
promotion activities, (iii) additional research development activities, (iv)
further investment in our Joint Venture and (v) venture investments or
acquisitions and/or (vi) support current operations. Recently, there
has been substantial volatility in the capital and financial markets due at
least in part to the constricted global economic environment resulting in
substantial uncertainty and access to financing is uncertain. Moreover, consumer
and as a consequence, customer spending habits may be adversely affected by the
current economic crisis. These conditions could have an adverse
effect on our industry and business, including our financial condition, results
of operations and cash flows.
To the
extent that we do not generate sufficient cash from operations, we may need to
incur indebtedness to finance plans for growth. Recent turmoil in the
credit markets and the potential impact on the liquidity of major financial
institutions may have an adverse effect on our ability to fund our business
strategy through borrowings, under either existing or newly created instruments
in the public or private markets on terms that we believe to be reasonable, if
at all.
Capital
Expenditures
Capital
expenditures during the remainder of fiscal 2010 are not expected to be
material.
Recently
Issued Accounting Standards
In
November 2008, the SEC issued for comment a proposed roadmap regarding the
potential use by U.S. issuers of financial statements prepared in accordance
with International Financial Reporting Standards (“IFRS”). IFRS is a
comprehensive series of accounting standards published by the International
Accounting Standards Board (“IASB”). Under the proposed roadmap, we could be
required in fiscal 2014 to prepare financial statements in accordance with IFRS.
The SEC will make a determination in 2011 regarding the mandatory adoption of
IFRS. We are currently assessing the impact that this potential change would
have on our consolidated financial statements and we will continue to monitor
the development of the potential implementation of IFRS.
25
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
In June
2009, the Financial Accounting Standards Board (“FASB”) modified the accounting
standard related to consolidation. This standard, as modified,
intends to improve financial reporting by enterprises involved with variable
interest entities. This standard, as modified, addresses the effects
on certain provisions relating to the Consolidation of Variable
Interest Entities, as a result of the elimination of the qualifying
special-purpose entity concept in the accounting standard related
to transfers and servicing, and constituent concerns about the
application of certain key provisions of this standard, including those in which
the accounting and disclosures under the standard do not always provide timely
and useful information about an enterprise’s involvement in a variable interest
entity. This standard, as modified, is effective as of the beginning
of each reporting entity’s first annual reporting period that begins after
November 15, 2009, for interim periods within that first annual reporting
period, and for interim and annual reporting periods thereafter. Earlier
application is prohibited. The adoption of the consolidation
standard, as modified, did not have a material effect on our consolidated
financial statements.
In
October 2009, the FASB issued Accounting Standards Update No. 2009-13,
"Multiple-Deliverable Revenue Arrangements" ("ASU No. 2009-13").
ASU No. 2009-13 amends guidance included within Accounting Standards
Codification ("ASC") Topic 605-25 to require an entity to
use an estimated selling price when vendor specific objective evidence or
acceptable third party evidence does not exist for any products or services
included in a multiple element arrangement. The arrangement consideration should
be allocated among the products and services based upon their relative selling
prices, thus eliminating the use of the residual method of allocation. ASU No.
2009-13 also requires expanded qualitative and quantitative disclosures
regarding significant judgments made and changes in applying this guidance. ASU
No. 2009-13 is effective prospectively for revenue arrangements entered into or
materially modified in fiscal years beginning on or after June 15,
2010. Early adoption and retrospective application are also
permitted. We are currently evaluating the impact of adopting the
provisions of ASU No. 2009-13.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains “forward looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). These forward looking statements relate
to future events or our future financial performance and involve known and
unknown risks, uncertainties and other factors that may cause our or our
industry’s actual results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity, performance or
achievements expressed or implied by the forward-looking
statements. Many of these factors are beyond our ability to
predict. Given the risks and uncertainties surrounding
forward-looking statements, you should not place undue reliance on these
statements. Forward-looking statements typically are identified by
use of terms such as “anticipate”, “believe”, “plan”, “expect”, “intend”, “may”,
“will”, “should”, “estimate”, “predict”, “potential”, “continue” and similar
words although some forward-looking statements are expressed
differently. This Report may contain forward-looking statements
attributed to third parties relating to their estimates regarding the growth of
our markets. You are cautioned that such forward looking statements
are not guarantees of future performance and that all forward-looking statements
address matters that involve risk and uncertainties, and there are many
important risks, uncertainties and other factors that could cause our actual
results, levels of activity, performance, achievements and prospects, as well as
those of the markets we serve, to differ materially from the forward-looking
statements contained in this Report.
26
ProPhase
Labs, Inc. and Subsidiaries
Management’s
Discussion and Analysis of
Financial
Condition and Results of Operations
Such
risks and uncertainties include, but are not limited to:
|
·
|
The
ability of our new management to successfully implement our business plan
and strategy;
|
|
·
|
Our
ability to fund our operations including the cost and availability of
capital and credit;
|
|
·
|
Our
ability to compete effectively including our ability to maintain and
increase our market share in the markets in which we do
business;
|
|
·
|
Our
dependence on sales from our main product, Cold-EEZEÒ,
and our ability to successfully develop and commercialize new
products;
|
|
·
|
The
uncertain length and severity of the current general financial and
economic downturn, the timing and strength of an economic recovery, if
any, and their impacts on our business including demand for our
products;
|
|
·
|
Our
ability to protect our proprietary
rights;
|
|
·
|
Our
continued ability to comply with regulations relating to our current
products and any new products we develop including our ability to
effectively respond to changes in laws and regulations or the
interpretation thereof including changing market rules and evolving
federal, state and regional laws and
regulations;
|
|
·
|
Potential
disruptions in our ability to manufacture our products or our access to
raw materials;
|
|
·
|
Seasonal
fluctuations in demand for our
products;
|
|
·
|
Our
ability to attract, retain and motivate key
employees;
|
|
·
|
Other
risks identified in this Report.
|
You
should also consider carefully the statements under other sections of this
Report and our Annual Report on Form 10-K for the year ended December 31, 2009,
which address additional risks that could cause our actual results to differ
from those set forth in any forward-looking statements. Our
forward-looking statements speak only as the date of this Report. We
undertake no obligation to publicly update or review any forward-looking
statements, whether as a result of new information, future developments or
otherwise.
27
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Our
operations are not subject to risks of material foreign currency fluctuations,
nor does it use derivative financial instruments in its investment practices. We
place our marketable investments in instruments that meet high credit quality
standards. We do not expect material losses with respect to its investment
portfolio or exposure to market risks associated with interest rates. The impact
on our results of one percentage point change in short-term interest rates would
not have a material impact on our future earnings, fair value, or cash flows
related to investments in cash equivalents or interest-earning marketable
securities.
Current
economic conditions may cause a decline in business and consumer spending which
could adversely affect our business and financial performance including the
collection of accounts receivables, realization of inventory and recoverability
of assets. In addition, our business and financial performance may be
adversely affected by current and future economic conditions, including due to a
reduction in the availability of credit, financial market volatility and
recession.
Item
4. Controls and Procedures.
Disclosure Controls and
Procedures
We
maintain disclosure controls and procedures designed to provide reasonable
assurance that material information required to be disclosed by us in the
reports filed or submitted under the Securities Exchange Act of 1934 is
recorded, processed, summarized and reported within the time periods specified
in the Securities and Exchange Commission (“SEC”) rules and forms, and that the
information is accumulated and communicated to our management, including our
Chief Executive Officer and Interim Chief Financial Officer, as appropriate to
allow timely decisions regarding required disclosure. We performed an
evaluation, under the supervision and with the participation of our management,
including the Chief Executive Officer and Interim Chief Financial Officer, of
the effectiveness of the design and operation of the disclosure controls and
procedures as of the end of the period covered by this Report. Based on the
existence of the material weaknesses discussed below under the heading “Material
Weaknesses” our management, including our Chief Executive Officer and Interim
Chief Financial Officer, concluded that our disclosure controls and procedures
were not effective at the reasonable assurance level as of the end of the period
covered by this Report.
Material
Weaknesses
As a
consequence of management’s review of its effectiveness of the design and
operation of the disclosure controls and procedures, and management’s
determination of the existence of material weaknesses, our management, including
our Chief Executive Officer and Interim Chief Financial Officer, concluded that
our disclosure controls and procedures were not effective at the reasonable
assurance level as of the end of the period covered by this
Report. A material weakness is a significant deficiency, or a
combination of significant deficiencies, that results in more than a remote
likelihood that a material misstatement of the annual or interim financial
statements will not be prevented or detected.
Material Weakness – Control
environment
Lack of management continuity due to
changes in executive management of the Company. As a
consequence of the results from the 2009 meeting of our shareholders whereby a
new slate of directors were confirmed by a major vote of the shareholders, our
former Chief Executive Officer and our former Chief Operating Officer resigned
without the benefit of a transition period between the effective date of their
respective resignations and the recruitment of new management. We
have filled both these positions with personnel who are new to the
Company. Additionally, in October 2009, the employment of our Chief
Financial Officer ended and the role was consolidated, on an interim basis, with
that of the new Chief Operating Officer. As a consequence of a lack
of continuity of management with limited or no transition or consultation period
with prior management, current management has concluded that this control
deficiency constitutes a material weakness.
28
Lack of documentation and/or the
availability of documentation or records in the Company’s files of business
transactions, contracts and/or evaluations engaged by the
Company. As new management was installed by the Board of
Directors, it was discovered during the second quarter of Fiscal 2009 that the
Company was either missing or lacked pertinent information regarding its
operations, including but not limited to certain business commitments to product
supply agreements, advertising programs, product placement initiatives and other
promotional initiatives, and asset sales. As a consequence of this
lack of documentation or availability of documentation or records, management
has concluded that this control deficiency constitutes a material
weakness.
Our
management, as part of their review of our internal control over financial
reporting, identified the above material weaknesses.
Remediation Plan for
Material Weaknesses
The
material weaknesses described above comprise control deficiencies that we
discovered during the financial close process for the June 30, 2009 fiscal
period.
Management
is making progress on its remediation plan which includes (i) obtaining and
reviewing the underlying documentation for significant agreements, contracts,
transactions and other material commitments entered into by the Company and (ii)
meeting with retail customers and vendors.
We
believe that these measures, if effectively implemented and maintained, will
remediate the material weaknesses discussed above.
Remediated Material
Weaknesses:
As of
December 31, 2009, management determined that it lacked certain subject matter
expertise in at least two of the following significant areas: (i) accounting for
and the disclosure of complex transactions and (ii) the selection, monitoring
and evaluation of certain vendors that provided services to
Pharma. At that time, our financial staff lacked sufficient training
or experience in accounting for complex transactions and the required disclosure
therein.
As part
of our remediation program implemented in Fiscal 2009, we (i) recruited a
financial and operations professional, Robert V. Cuddihy, Jr., to our executive
management, (ii) reorganized the financial staff, including personnel changes
and recruitment, (iii) implemented a continuous education and
training program for our financial staff, (iv) retained of outside financial
consultants to augment our financial staff with certain subject matter
expertise, (v) reorganized Pharma staff and retained of outside consultants to
augment such Pharma staff with certain subject matter expertise and conducted a
thorough review of the entire research and development portfolio of potential
products. As a consequence of these actions taken by management, management
believes that it has sufficiently remediated these material weaknesses in the
quarter ended March 31, 2010.
Changes in Internal Control
Over Financial Reporting
We are
currently undertaking a number of measures to remediate the material weaknesses
discussed above. Those measures, described under “Remediation Plan
for Material Weaknesses,” implemented during the third and fourth quarter of
Fiscal 2009, will materially affect, or are reasonably likely to materially
affect, our internal control over financial reporting. Other than as described
above, there have been no changes in our internal control over financial
reporting during the three months ended March 31, 2010 that have materially
affected, or are reasonably likely to materially affect, our internal control
over financial reporting.
Because
of its inherent limitations, a system of internal control over financial
reporting can provide only reasonable assurance and may not prevent or detect
misstatements. Further, because of changes in conditions,
effectiveness of internal controls over financial reporting may vary over
time. Our system contains self-monitoring mechanisms, and actions are
taken to correct deficiencies as they are identified.
29
Part II. Other
Information
Item
1. Legal Proceedings.
THOMAS A. SIMONIAN VS. THE
QUIGLEY CORPORATION
On
February 24, 2010, an action was commenced in the United States District Court
for the Northern District of Illinois Eastern Division by Mr. Thomas Simonian
against us for false patent marketing under 35 U.S.C. § 292. Mr.
Simonian claims that our Cold-EEZE®
packaging references certain patents which have been expired since June 10, 2005
and August 3, 2007. On such information and belief, Mr. Simonian
claims that the Company marks certain of its Cold-EEZE® branded
products with the expired patents with the intent to deceive the public and to
gain a competitive advantage in the market. Mr. Simonian is seeking
an award of monetary damages.
We are
investigating this claim. At this time no prediction can be made as
to the outcome of this case.
PUBLIC PATENT FOUNDATION,
INC. VS. THE QUIGLEY CORPORATION
On
February 24, 2010, an action was commenced in the United States District Court
for the Southern District of New York by Public Patent Foundation, Inc. (“PPF”)
against us for false patent marketing under 35 U.S.C. § 292. PPF
claims that our Cold-EEZE®
packaging references certain patents which have been expired since June 10, 2005
and August 3, 2007. On such information and belief, PPF claims that
the Company marks certain of its Cold-EEZE® branded
products with the expired patents with the intent to deceive the public and to
gain a competitive advantage in the market. PPF is seeking an award
of monetary damages.
We are
investigating this claim. At this time no prediction can be made as
to the outcome of this case.
Item
1A. Risk Factors.
The
Company has identified material weaknesses in its internal control environment
for the period from April 1, 2009 through March 31, 2010.
These
material weaknesses, if not properly remediated, could result in material
misstatements in our financial statements in future periods and impair its
ability to comply with the accounting and reporting requirements applicable to
public companies. A material weakness is a control deficiency, or combination of
control deficiencies, that results in more than a remote likelihood that a
material misstatement of financial statements will not be prevented or detected
by our internal controls.
In
relation to the condensed consolidated financial statements for the period from
April 1, 2009 through March 31, 2010, we identified material weaknesses in its
internal control environment as follows: (i) lack of management
continuity due to changes in executive management of the Company and (ii) lack
of documentation and/or the availability of documentation or records in the
Company’s files of business transactions, contracts and/or evaluations engaged
by the Company.
Following
the identification of these material weaknesses in our internal control
environment, management took measures and plans to continue to take measures to
remediate these weaknesses and deficiencies. However, the implementation of
these measures may not fully address these weaknesses. A failure to correct
these weaknesses or other control deficiencies or a failure to discover and
address any other control deficiencies could result in inaccuracies in our
condensed consolidated financial statements and could impair our ability to
comply with applicable financial reporting requirements and related regulatory
filings on a timely basis and could cause investors to lose confidence in our
reported financial information, which could have a negative impact on our
financial condition and stock price. Our management identified the above
material weaknesses as part of their review of the Company’s internal control
over financial reporting.
30
Item
2. Unregistered Sales of Equity Securities
and Use of Proceeds.
Pursuant
to the Original License Agreement, we issued 1,440,000 shares of our Common
Stock having an aggregate value of approximately $2.6 million to PSI Parent
(such shares, the “PSI Shares”), and made a one-time payment to PSI Parent of
$1.0 million. PSI Parent has agreed, pursuant to a Share Transfer
Restriction Agreement, dated March 22, 2010, between us and PSI Parent, that,
with certain exceptions, it will not sell or otherwise dispose of any of the PSI
Shares prior to June 1, 2012. The PSI Shares were issued pursuant to
an exemption from registration under the Securities Act, by virtue of Section
4(2) of the Securities Act and by virtue of Rule 506 of Regulation D under the
Securities Act. Such sale and issuance did not involve any public
offering and was made without general solicitation or
advertising. Additionally, PSI Parent represented to us, among other
things, that PSI Parent is not a US Person (as defined in Regulation S under the
Securities Act), that PSI Parent is an accredited investor with access to all
relevant information necessary to evaluate its investment and that the PSI
Shares were being acquired for investment purposes only.
Pursuant
to the term of his employment agreement with the Company, Mr. Cuddihy, our Chief
Operating Officer and Interim Chief Financial Officer, is entitled to an annual
grant of restricted shares of Common Stock payable quarterly, promptly following
the close of each quarter. Mr. Cuddihy was issued 11,004 shares of Common Stock
as compensation for services in Fiscal 2009 pursuant to his employment agreement
with the Company. These shares were issued to Mr. Cuddihy by the
Company on February 24, 2010.
Item
3. Defaults Upon Senior Securities.
Not
applicable
Item
5. Other Information.
Not
applicable
Item
6. Exhibits
(1)
|
Exhibit
31.1
|
Certification
by the Chief Executive Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
(2)
|
Exhibit
31.2
|
Certification
by the Chief Financial Officer pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002
|
(3)
|
Exhibit
32.1
|
Certification
by the Chief Executive Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
(4)
|
Exhibit
32.2
|
Certification
by the Chief Financial Officer pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
31
SIGNATURES
Pursuant
to the requirements 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.
ProPhase
Labs, Inc.
|
|||
By:
|
/s/ Ted
Karkus
|
||
Ted
Karkus
|
|||
Chairman
of the Board and Chief Executive Officer
|
|||
(Principal
Executive Officer)
|
|||
Date:
May 13, 2010
|
|||
By:
|
/s/ Robert
V. Cuddihy, Jr.
|
||
Robert
V. Cuddihy, Jr.
|
|||
Chief
Operating Officer and Interim Chief Financial Officer
|
|||
(Principal
Accounting and Financial Officer)
|
|||
Date:
May 13, 2010
|
32