Message #22 From:
NewsBot Date: November 15, 2006 09:38:00 AM
EMFP News Emergency Filtration Reports Third Quarter Results
HENDERSON, Nev.--(BUSINESS WIRE)--Emergency Filtration Products, Inc. (EFP) (OTCBB: EMFP) today reported
net loss of $ (629,970) on net sales of $ 78,562 for the third quarter
ended September 30, 2006 ($0.01 per share). For the comparable year-ago
period, the company reported a loss of $ (206,622) ($0.01 per share) on
net sales of $ 54,149.
For the nine months ended September 30, 2006, the company reported net
income of $ 1,634,666 on net sales of $ 4,131,475 as compared to a net
loss of $ (605,085) ($0.02 per share) on net sales of $ 119,960 for the
comparable year-ago period.
The Company filed a 510k application with the FDA during September 2006
in an effort to have the environmental mask and filter registered as a
surgical mask. The Company has met with the FDA, has received comments
back from the FDA regarding the 510k application, and is working
diligently to address the FDA’s comments.
Although no assurance can be given as to when or even if it will be able
to obtain regulatory approval of the products with the FDA as a surgical
mask, the Company believes that obtaining the FDA approval will increase
the demand for the products nationally and internationally. Because the
510k application of the environmental mask and filters with the FDA is
currently under review and comments, the Company has suspended all sales
to its domestic distributors, pending the outcome of the approval
process. Because of this suspension, the Company experienced a
significant decrease in revenues for the three-month period ended
September 30, 2006.
In addition, because of the pending approval of the products with the
FDA, the Company’s distributors who have
purchased product during 2006 have also suspended their sale of the
products, and thus the Company has not collected on the outstanding
receivables from these distributors. The Company is aggressively
pursuing collection of these receivables, however, and expects to
receive payment in the near future. The Company has recorded an
estimated allowance for bad debts against these receivables totaling
$310,000 to cover any potential losses to be incurred for
non-collections.
To date, the Company has sold approximately 300,000 masks and
approximately 4,500,000 filters to various domestic and international
distributors. Due to numerous delays that the international distributors
are experiencing with customs and international product markings, the
Company has extended payment terms for these international distributors
(totaling approximately $750,000).
At the election of a domestic distributor, the large sale of masks and
filters to this distributor during June 2006 has not been re-sold by the
distributor at the present time, pending the outcome of the 510k
approval with the FDA. The Company has also extended payment terms for
this distributor as well (approximately $2,125,000). This domestic
distributor is currently working on possible international customers to
buy the products. The distributor had originally planned to sell the
product to a government agency, which agency was to distribute the
product internationally in a region that recognizes the FDA approval as
valid for a medical device. As a result of the delay in the FDA approval
as previously discussed, the distributor has been unable to effectuate
the sale of the purchased environmental masks and filters and has asked
the Company for an extension of payment terms until such time that the
FDA approval process has been resolved satisfactorily, or such time that
the distributor is able to distribute the product to an international
customer not requiring FDA approval.
As a result of the described delays, the Company has reported a
substantial increase in accounts receivable at September 30, 2006. The
Company has recorded an allowance for bad debts totaling $310,000 at
September 30, 2006, to cover any potential losses to be incurred for
non-collection of these accounts receivable in the future. Beyond this
allowance for bad debts, the Company believes that all such remaining
accounts are fully collectible and will be paid in full.
During August 2006, the Company announced that its environmental mask
and filters had been registered with the Therapeutics Goods
Administration (TGA) (the Australian counterpart to the United States
FDA) as a Class I medical device. As a result of this registration, the
Company’s exclusive Australian distributor
planned to launch an extensive marketing campaign in Australia. However,
during October 2006, the TGA commenced an audit of the registration,
which led to the suspension of all planned marketing activities in
Australia by the Australian distributor, pending the outcome of the
audit. The Australian distributor, however, continues to market the
product in the Pacific Rim. The Company is working diligently with its
Australian distributor to answer all questions that have been posed by
the TGA, has submitted the documentation and the answers requested by
the TGA, and is currently waiting for the TGA’s
response. The Company cannot currently predict when the TGA audit will
be finalized.
“The decision to seek FDA approval led us to
suspend sales to domestic distributors, a factor which had a significant
negative impact on revenues,” said Douglas K.
Beplate, the Company’s President. “The
suspension of our Australian distributor’s
marketing campaign, which resulted from an audit after our NanoMask had
been registered with the TGA, was another contributing factor to the
decline in revenues.”
Mr. Beplate went on to add: “While these
factors have contributed to unsatisfactory third quarter results, we
believe that obtaining all of the necessary regulatory approvals is the
only way that we will be able to freely market the NanoMask and NanoMask
filters. As painful as the short-term consequences of these decisions
are, management believes that they are necessary for the long term, and
will enable the company to generate significant revenues and strong
profitability.”
About Emergency Filtration Products, Inc.
EFP is an air filtration products manufacturer whose patented 2H
Technology™ filter system has produced
filtration efficiencies of "greater than 99.99%" at a particulate size
of 0.027 microns. EFP's initial products were developed for the medical
market: the Vapor
Isolation Valve™ and
RespAide®CPR Isolation Mask used for
resuscitation of respiratory/cardiac arrest cases; and 2H Breathing
Circuit Filter for ventilators, respirators and anesthesia circuitry.
Each has received FDA approval. The Company also markets an Automated
External Defibrillator Prep Kit featuring RespAide; and the
NanoMask®, a nanotechnology enhanced
environmental mask. In addition to filtration products, the company
supplies Superstat®,
a modified hemostatic collagen, to the U.S. Military for surgery and
extreme wound care.
Safe Harbor Statement
This release may contain statements that are forward looking. Such
statements are made based upon current expectations that are subject to
risk and uncertainty. EFP does not undertake to update forward-looking
statements in this news release to reflect actual results of and changes
in assumptions or changes in other factors affecting such
forward-looking information. The actual future results of the company
could differ significantly from such forward-looking statements.
Specifically, the timing for obtaining regulatory approval cannot be
predicted, and such approval of the NanoMask products, if obtained, may
not translate into significant sales. Future sales may also be dependent
on the success of marketing campaigns, the signing of definitive
agreements with additional distributors, and both the perceived need for
EFP's products and the competitive performance of such products in the
marketplace.