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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 8, 1997
Meridian Medical Technologies, Inc.
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(Exact name of registrant as specified in its charter)
Delaware 0-5958 52-0898764
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(State or other jurisdiction (Commission (I.R.S. employer
of incorporation) file number) identification no.)
10240 Old Columbia Road, Columbia, MD 21046
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code: (410) 309-6830
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
The press release dated October 8, 1997 filed herewith as Exhibit
(1), is incorporated by reference herein.
Item 7. Financial Statements and Exhibits.
(c) Exhibits
(1) Press release dated October 8, 1997.
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.
MERIDIAN MEDICAL TECHNOLOGIES, INC.
Date: October 17, 1997 By: /s/ G. Troy Braswell, Jr.
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G. Troy Braswell, Jr.
Vice President and Chief
Financial Officer
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Exhibit (1)
Meridian Announces A Nationwide Voluntary Product
Exchange of EpiEZPen(R) Auto-Injectors
COLUMBIA, Md., Oct. 8 /PRNewswire/ -- Meridian Medical
Technologies, Inc. (Nasdaq: MTEC) today announced that it is conducting
a nationwide precautionary product exchange program in which consumers
should return any EpiEZPen(R) or EpiEZPen Jr. (R) auto-injector for a
free replacement with the EpiPen(R) or EpiPen Jr.(R) auto-injector, all
of which are used for emergency treatment of severe allergic reactions.
While more than 99.99 percent of EpiEZPen model auto-injectors continue
to function correctly, a small number may spontaneously activate,
rendering them ineffective in the event of a medical emergency.
Consumers with EpiEZPen or EpiEZPen Jr. should return them to the place
of purchase to receive a free EpiPen or EpiPen Jr. For further
information consumers may call 1-800-527-4278 or 1-800-755-5560.
Meridian will include the financial impact of this voluntary
product exchange in its financial results for the fourth quarter and
fiscal year ended July 31, 1997 to be issued in its 10-K filing. The
exchange program is expected to have no significant impact on the
company's long-term performance.
"Although spontaneous activation in the EpiEZPen model auto-
injector appears to be at an extremely low level, we have voluntarily
initiated this exchange program for the ultimate protection of our
patients," said James H. Miller, chairman, president and chief
executive officer of Meridian. "Unexpired units are safe and effective
for use if they have not spontaneously activated. Patients should not
hesitate to use their EpiEZPen or EpiEZPen Jr. if they are needed in a
medical emergency prior to being replaced."
Spontaneous activation in the EpiEZPen or EpiEZPen Jr. model
auto-injector does not involve the more widely distributed EpiPen or
EpiPen Jr. model, which is mechanically different but contains an
equivalent dose of epinephrine. EpiEZPen units that experience
spontaneous activation will have an exposed needle at the black tip of
the auto-injector, which is easy for the consumer to detect in advance
of use. Periodic examination of the EpiEZPen and EpiEZPen Jr. should be
conducted until there is an opportunity to exchange the unit.
This preventive measure follows a recent voluntary recall of one
lot of EpiEZPen due to a small number of auto-injectors that were
returned for premature activation. EpiEZPen and EpiEZPen Jr. are
distributed by Dey Laboratories, and are identified on the
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packaging under the names of Survival Technology, Inc. and Center
Laboratories.
"The investigation into the cause of spontaneous activation in the
EpiEZPen is rapidly progressing at this time," Mr. Miller said.
"Preliminary information collected by experts in the field has focused
the investigation on manufacturing and process controls at component
suppliers. The exchange program is a proactive step on the part of our
company to ensure that every consumer is protected, which is our number
one priority."
Meridian has manufactured approximately 150 million auto-
injectors in the history of the company and has produced EpiPen for
more than 17 years. The company expects that following the completion
of the root cause analysis for the spontaneous activation in the
EpiEZPen model auto-injector, corrective action will be implemented and
the improved product will be reintroduced in the market place.
The after-tax financial impact of this voluntary product exchange
is estimated not to exceed $950,000. In accordance to GAAP, this event
is treated as a "post balance sheet subsequent event" and the financial
impact of this event will be reflected in fourth quarter and fiscal
year ended July 31, 1997 financial results to be reported in the
company's 10-K filing. The event was not known at the time the company
announced fourth quarter and fiscal year ended results on September 4,
1997. The company estimates its fourth quarter financial results to be
a net income of $31,000 or $0.01/share from a previously announced net
income of $978,000 or $0.31/share. Fiscal year financial results,
excluding one-time, merger related costs, will be an estimated net loss
of $456,000 ($0.16)/share from previously announced net income of
$491,000 or $0.17/share.
"This event was unknown when the company announced its financial
results on September 4th," Miller emphasized. "Including this item in
fiscal 1997 results is unfortunate but appropriate given its recent
discovery. However, we should not lose sight of the fact that the
EpiEZPen is a new product, having been introduced in March 1996.
Revenues from the EpiEZPen since its introduction amount to less than
10 percent of total company sales. Moreover, growth continues strong
for the established EpiPen product and we are enjoying strong new
orders in our STI Military business unit. We believe the company is
well positioned for long-term growth."
Meridian Medical Technologies is a worldwide leader in the
development of auto-injector drug delivery systems. The company
also develops and manufactures emerging products for the
cardiopulmonary care market. Meridian Medical Technologies
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provides technology solutions for medicine in early intervention
home healthcare and emergency medical technologies. Additional
company information is available on the World Wide Web at
www.meridianmeds.com
SOURCE Meridian Medical Technologies
-0- 10/08/97
/CONTACT: James H. Miller, President and CEO, or G. Troy
Braswell, V.P. Finance and CFO, 800-638-8093, both of Meridian
Medical Technologies/
/Web site: www.meridianmeds.com/
(MTEC)
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