UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended October 31, 1999
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from: ________________ to _______________
Commission file number: 0-5958
MERIDIAN MEDICAL TECHNOLOGIES, INC.
------------------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 52-0898764
- ------------------------------- -------------------
(State or other jurisdiction of (IRS Employer
incorporation or organization) Identification No.)
10240 Old Columbia Road, Columbia, Maryland 21046
- ------------------------------------------- -----
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 410-309-6830
------------
Indicate by check mark whether the Registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
YES [X] NO [ ]
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.
Class Outstanding as of December 15, 1999
- ---------------------------- -----------------------------------
Common Stock, $.10 par value 2,994,930 Shares
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
Page No.
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PART I. FINANCIAL INFORMATION
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ITEM 1. Consolidated Financial Statements
Consolidated Balance Sheets as of
October 31, 1999 and July 31, 1999............................................................... 4
Consolidated Statements of Operations for
the Three Months Ended October 31, 1999 and 1998 ................................................ 5
Consolidated Statements of Cash Flows for
the Three Months Ended October 31, 1999 and 1998................................................. 6
Notes to Consolidated Financial Statements.......................................................... 7
ITEM 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations............................................................. 8
ITEM 3 Quantitative and Qualitative Disclosures About Market Risk.......................................... 11
PART II. OTHER INFORMATION
- --------------------------
ITEM 6. Exhibits and Reports on Form 8-K................................................................... 12
SIGNATURES.......................................................................................................... 13
EXHIBIT INDEX....................................................................................................... 14
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MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
INTRODUCTION
Meridian Medical Technologies, Inc. ("MMT', "Meridian", or the "Company") is a
medical device and drug delivery system company focusing on Early Intervention
Healthcare and Emergency Medical Technologies. The Company has three areas of
business. The Injectable Drug Delivery Systems business focuses on injectable
drug delivery devices with an emphasis on commercial auto-injectors. This
business also supplies customized drug delivery system design, pharmaceutical
research and development, and sterile product manufacturing to pharmaceutical
and biotechnology companies. The Cardiopulmonary Systems business focuses on
non-invasive cardiac diagnostics and telemedicine. The Cardiopulmonary Systems
business is preparing to begin the European distribution phase for the PRIME ECG
system, an 80-lead cardiac mapping system designed for rapid and improved
diagnostic accuracy of cardiac ischemia. Multiple distributors in major western
European markets are being targeted and, subject to the completion of
negotiations and execution of distribution agreements, will become distributors
of the system over the coming months. A U.S. based FDA clinical study of the
PRIME ECG system began in November 1999. Meridian intends to complete the U.S.
clinical study by the fourth quarter of fiscal 2000. Subject to a successful
completion of the clinical, a 510(k) application will be made to the FDA for
approval to market the product in the U.S. The Government Systems business
focuses on the world-wide market for auto-injectors used for self-administration
of nerve agent antidotes, morphine and diazepam, and markets to the U.S. and
allied governments, as well as local governments for civil defense applications.
FORWARD LOOKING STATEMENTS
This report contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act with respect to financial performance
and other financial and business matters. Forward-looking statements are
typically identified by future or conditional verbs or similar expressions
regarding events that have yet to occur. These forward-looking statements are
based on the Company's current expectations and are subject to numerous
assumptions, risks and uncertainties. The following factors, among others, could
cause actual results to differ materially from forward-looking statements: (i)
economic and competitive conditions in markets and countries where the Company
offer products and services; (ii) changes in capital availability or costs;
(iii) fluctuations in demand, including changes in government procurement
policy; (iv) technological challenges associated with the development and
manufacture of current and anticipated products; (v) commercial acceptance of
auto-injectors and competitive pressure from traditional and new drug delivery
methods; (vi) delays, costs and uncertainties associated with government
approvals required to market new drugs and medical devices; (vii) availability
of raw materials in adequate quantities at reasonable prices and sufficient
quality; (viii) costs of the Company's EpiPen voluntary recall and/or EpiEZPen
voluntary product exchange associated with differences from management's
estimate of the number of returned units, total costs or adverse impact on
future sales; (ix) success and timing of cost reduction programs; (x) adequacy
of product liability insurance; (xi) factors related to PRIME ECG including
successful product completion, results of clinical testing and applications for
regulatory approvals, degree of market acceptance and ability to obtain
strategic alliances; (xii) expiration of patents and the ability of competitors
to design around the Company's patent protection; and (xiii) factors relating to
Year 2000 issues. Additional information is included in our Annual Report on
Form 10-K. Meridian assumes no duty to update forward-looking statements.
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MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
PART I. FINANCIAL INFORMATION
- -----------------------------
ITEM 1. Financial Statements
MERIDIAN MEDICAL TECHNOLOGIES, INC.
-----------------------------------
CONSOLIDATED BALANCE SHEETS
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(In thousands, except share data)
---------------------------------
October 31, July 31,
Assets 1999 1999
------ ----------- --------
Current assets:
Cash and cash equivalents $ 432 $ 227
Restricted cash 280 278
Receivables, less allowances of $544 and $467, respectively 9,624 9,557
Inventories 8,122 6,889
Deferred income taxes 1,965 1,965
Prepaid income taxes 316 546
Other current assets 700 771
---------- ----------
Total current assets 21,439 20,233
---------- ----------
Property, plant and equipment 21,835 21,407
Less - Accumulated depreciation 5,996 5,581
---------- ----------
Net property, plant and equipment 15,839 15,826
---------- ----------
Deferred financing fees 738 749
Capitalized software costs 1,588 1,588
Excess of cost over net assets acquired, net 7,138 7,403
Other intangible assets, net 1,869 1,952
---------- ----------
Total assets $ 48,611 $ 47,751
========== ==========
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and other accrued liabilities $ 7,693 $ 7,080
Note payable to bank 7,403 7,317
Customer deposits 54 54
Current portion of long-term debt 1,370 1,409
---------- ----------
Total current liabilities 16,520 15,860
---------- ----------
Long-term debt - notes payable, net of discount 17,393 17,582
Long-term debt - other 33 57
Deferred income taxes 1,793 1,793
Other non-current liabilities 754 721
Shareholders' equity:
Common stock
Par value $.10 per share; 18,000,000 shares authorized;
2,994,930 and 2,994,930 shares issued and outstanding 299 299
Additional capital 32,187 32,187
Cumulative translation adjustment 3 (14)
Accumulated deficit (20,097) (20,451)
Unearned stock option compensation (61) (70)
Treasury stock, at cost (213) (213)
---------- ----------
Total shareholders' equity 12,118 11,738
---------- ----------
Total liabilities and shareholders' equity $ 48,611 $ 47,751
========== ==========
The accompanying notes are an integral part of these
consolidated financial statements.
4
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
MERIDIAN MEDICAL TECHNOLOGIES, INC.
-----------------------------------
CONSOLIDATED STATEMENTS OF OPERATIONS
-------------------------------------
(In thousands, except per share data)
-------------------------------------
Three Months Ended
October 31,
1999 1998
---- ----
Net sales $ 11,755 $ 10,850
Cost of sales 7,067 6,673
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Gross profit 4,688 4,177
Selling, general, and administrative expenses 1,883 1,830
Research and development expenses 517 248
Depreciation and amortization 806 902
--------- ---------
3,206 2,980
--------- ---------
Operating income 1,482 1,197
Other (expense) income:
Interest expense (843) (848)
Other (expense) income (58) 10
--------- ---------
(901) (838)
--------- ---------
Income before income taxes 581 359
Provision for income taxes 227 93
--------- ---------
Net income $ 354 $ 266
========= =========
Net income per share:
Basic $ .12 $ .09
========= =========
Diluted $ .11 $ .08
========= =========
Weighted average shares:
Basic 2,994 2,991
Diluted 3,189 3,281
The accompanying notes are an integral part of these
consolidated financial statements.
5
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
MERIDIAN MEDICAL TECHNOLOGIES, INC.
-----------------------------------
CONSOLIDATED STATEMENTS OF CASH FLOWS
-------------------------------------
(In thousands)
--------------
Three Months Ended
October 31,
1999 1998
---- ----
OPERATING ACTIVITIES:
Net income $ 354 $ 266
Adjustments to reconcile net income to net cash
provided by (used for) operating activities:
Depreciation and amortization 806 902
Amortization of notes payable discount and deferred
financing fees 92 111
Changes in assets and liabilities
Receivables (144) (922)
Inventories (1,233) (2,379)
Other current assets 301 27
Accounts payable and other accrued liabilities 646 48
Other 60 48
---------- -----------
Net cash provided by (used for) operating activities 882 (1,899)
INVESTING ACTIVITIES
Purchase of fixed assets (428) (265)
(Increase) decrease in restricted cash (2) (2)
---------- -----------
Net cash used for investing activities (430) (267)
FINANCING ACTIVITIES
Net proceeds from line of credit 86 2,303
Net (payment) on long-term debt (313) -
Net (payment) proceeds on other long-term debt - (83)
Payment of financing fees (20) -
---------- -----------
Net cash provided by (used for) financing activities (247) 2,220
---------- -----------
Net increase in cash 205 54
Cash at beginning of period 227 284
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Cash at end of period $ 432 $ 338
========== ===========
The accompanying notes are an integral part of these
consolidated financial statements.
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MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. In the opinion of management, the accompanying unaudited consolidated
financial statements contain all adjustments (consisting of normal
recurring accruals) necessary to present fairly the Company's financial
position as of October 31, 1999, and the results of its operations and
cash flows for the three month periods ended October 31, 1999 and 1998.
The results of operations for the three month period ended October 31,
1999 are not necessarily indicative of the results that may be expected
for the fiscal year ending July 31, 2000.
2. Inventories consisted of the following:
October 31, July 31,
1999 1999
---- ----
Components and subassemblies $ 5,320 $ 3,667
Work in process 2,587 3,325
Finished goods 553 335
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8,460 7,327
Less: inventory valuation allowance (338) (438)
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$ 8,122 $ 6,889
========== =========
3. A reconciliation of net income to comprehensive income is as follows:
Three Months Ended October 31,
1999 1998
---- ----
Net income $ 354 $ 266
Foreign exchange translation adjustment 17 60
------ ------
Comprehensive income $ 371 $ 326
====== ======
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MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations
The Quarter in Review
MMT's net income was $354,000($.12 basic and $.11 diluted earnings per share) on
sales of $11.8 million for the quarter ended October 31, 1999, the first quarter
of fiscal 2000. This compares with net income of $266,000 ($0.09 basic and $.08
diluted earnings per share) on sales of $10.9 million in the same period of
fiscal 1999.
This represents a 33% increase in net income and an 8% increase in sales.
Revenues of MMT's three areas of business and total gross profit for the
quarters ended October 31, 1999 and 1998 are as follows:
Three months ended October 31,
($thousands) 1999 1998
---- ----
Drug Delivery Systems $ 6,123 $ 6,021
Government Systems 5,491 4,676
Cardiopulmonary Systems 141 153
----------- -----------
Total Revenues 11,755 10,850
=========== ===========
Gross Profit $ 4,688 $ 4,177
=========== ===========
Gross Profit % 39.9% 38.5%
Drug Delivery Systems business revenue in the fiscal first quarter ended October
31, 1999 was $6.1 million, $0.1 million higher than in the comparable prior year
period. The 2% increase in revenue resulted from a consistent level of EpiPen
sales and higher R&D and pharmaceutical manufacturing revenues. First quarter
activities of the Drug Delivery Systems business included a continuation of the
FDA approval process for generic drugs under the alliance with Mylan
Laboratories with revenues continuing into fiscal 2000. This resulted in the
approval of the third generic drug in November 1999. The Company believes
demand for the EpiPen product line is strong and expects sales to reach a record
level in fiscal 2000.
Government Systems revenues were $5.5 million in the first quarter of fiscal
2000 compared to $4.7 million in the prior year comparable period. The 17%
higher revenues resulted primarily from increased fees under the renewed base
maintenance contract with the U.S. DoD, as well as higher sales to foreign
governments. The Company continues to develop the multi-chambered auto-injector
(MA), the next-generation military drug delivery system. The MA features a dual
chamber that allows the automatic injection of two drugs in succession using the
same device. A New Drug Application (NDA) for the MA has been submitted to the
FDA. Production is anticipated to begin in the first half fiscal 2001, subject
to the requisite approvals and government purchase orders.
Cardiopulmonary Systems revenues were $141,000 in the current year fiscal first
quarter compared to $153,000 in the prior year fiscal first quarter. The
revenues reflected fairly consistent sales of the Company's telemedicine line of
products. MMT received clearance from the FDA of its Investigative Device
Evaluation (IDE) application in September to begin clinical trials on the PRIME
ECG cardiac mapping system. The PRIME ECG is a unique, 80-lead electrocardiac
mapping system that offers the potential to significantly improve the diagnosis
and treatment of heart disease. Clinical trials began in November 1999 at the
Medical College of Virginia, and the Company intends to complete the trials and
submit results to the FDA for marketing approval by the end of fiscal 2000.
Gross profits were $4.7 million or 39.9% of revenues during the first quarter of
2000, up from the 38.5% reported for the prior year comparable period.
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MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
Operating costs were $3.2 million in the fiscal 2000 first quarter, $226,000
higher than in the first quarter of last year. Selling, general and
administrative expenses (SG&A) were at a consistent level with the same period
last year. The Company is not presently capitalizing any software development
costs related to PRIME as the product progresses through U.S. clinical trials.
R&D expenses for the first quarter increased by $269,000 reflecting the absence
of this cost capitalization, which was $373,000 in the first quarter of last
year.
Interest expense was $843,000 in the first quarter of fiscal 2000, consistent
with that of the comparable prior year period.
The provision for income taxes in the first quarter of fiscal 2000 was $227,000
reflecting an estimated effective tax rate of 39% for the year. The tax
provision incorporates estimated benefits from utilization of operating loss
carryforwards, offset by permanent book to tax differences.
Liquidity and Capital Resources
Total cash as of October 31, 1999 was $432,000, an increase of $205,000 from the
prior year ended July 31, 1999. The Company generated $882,000 of cash from
operations in the first quarter of fiscal 2000 attributable mostly to net income
plus non-cash expenses. Investing activities in the three months of fiscal 2000
used $430,000 of cash for capital additions. Financing activities used $247,000,
primarily due to a scheduled principal payment on the term loan from ING
CAPITAL. Availability under the working capital lines of credit was $1.3 million
at October 31, 1999.
Working capital at October 31, 1999 was $4.9 million, up from $4.4 million at
July 31, 1999. The increase was primarily attributable to higher inventories
($1.2 million) partially offset by higher accounts payable and other accrued
liabilities ($613,000). At October 31, 1999, accounts receivable were $9.6
million, representing 73 days-sales-outstanding, and inventories were $8.1
million representing a turn-over rate of 3.8 times per year.
Year 2000
The Company's Program - The Company has undertaken a program to address the Year
2000 issue ("Y2K") with respect to the following: (i) the Company's information
technology and operating systems (including its billing, accounting and
financial reporting systems); (ii) the Company's non-information technology
systems (such as buildings, plant, equipment and other infrastructure systems
that may contain embedded micro-controller technology); (iii) certain systems of
the Company's major suppliers and material service providers (insofar as such
systems relate to the Company's business activities with such parties); and (iv)
the Company's major distributors (insofar as the Year 2000 issue relates to the
ability of such distributors to distribute the Company's products). As described
below, the Company's Year 2000 program involves (i) an assessment of the Year
2000 problems that may affect the Company, (ii) the development of remedies to
address the problems discovered in the assessment phase, (iii) the testing of
such remedies and (iv) the preparation of contingency plans to deal with worst
case scenarios.
Assessment Phase - As part of the assessment phase of its program, the Company
has attempted to identify substantially all of the major components of the
systems described above. In order to determine the extent that such systems are
vulnerable to the Year 2000 issue, a Y2K three-tier matrix was applied to MMT
systems. Tier-one systems are mission critical and tier-two systems are critical
business operations. Mission-critical (Tier 1) can be defined as extended
downtime (1+ hr.) for 30 or more employees. Downtime for 5-30 employees lasting
from 2 to 24 hours is categorized as critical (Tier 2). The last tier, three, is
for productivity systems that are important to the ongoing improvement of the
business; MMT however, could operate without these systems for a period of time
(days).
Remediation and Testing Phase - Based upon the results of its assessment
efforts, the Company has undertaken remediation and testing activities which are
intended to address potential Year 2000 problems in computer
9
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
software used by the Company in its information technology and non-information
technology systems in an attempt to demonstrate that this software will be made
substantially Year 2000 compliant on a timely basis. In this phase, the Company
first evaluated a program application and, if a potential Year 2000 problem was
identified, it took steps to remediate the problem and individually test the
application to confirm that the remediating changes were effective and did not
adversely affect the functionality of that application.
It was determined that all MMT systems had a completed plan and are Y2K
compliant, as of the date of this filing, with the exception of minor
remediation efforts in Tier 3 that will be completed during December 1999. The
following summarizes the efforts being made:
a. Y2K readiness is complete for all Tier 1 and Tier 2 systems.
b. MMT is a medium-sized company with packaged software purchased
from reliable vendors. The vendor supplies Y2K compliant programs
and all released Y2K upgrades have been applied to the MMT
systems.
c. MMT has no Tier 1 or 2 systems that are proprietary or custom
designed that need to be fixed internally.
d. All Tier 1 and 2 systems are supported by vendor contracts or
through excellent relationships with MMT. All contracts for Tier 1
and 2 systems are through the year 2000.
e. Vendors supplying components or PLCs have submitted documentation
to MMT concerning their Y2K readiness.
f. Programmable Logic Controllers (PLC), Lab and testing equipment
used with machinery that produces MMT product could malfunction
and stop production. All PLCs, Lab and testing equipment is Y2K
ready.
g. Low risk Tier 3 systems have been addressed. Y2K readiness will
be complete prior to year-end for Tier 3.
MMT will still be dependent on some suppliers, such as utility and
telecommunication companies. To address this risk, MMT's current forecast and
orders have been adjusted with our customers' input. MMT believes that all
customer orders will be unaffected during the transition to the Year 2000.
Contingency Plans - The Company developed a contingency plan to handle its most
likely worst case Year 2000 non-compliant scenarios. The sales forecast was then
adjusted to reflect these scenarios.
Costs Related to the Year 2000 Issue - To date, the Company's costs, which have
been expensed as incurred, have amounted to $178,000. The costs and timetable in
which the Company completes the Year 2000 readiness activities are based on
management's best estimates, which are derived using numerous assumptions,
including the continued availability of certain resources, third-party readiness
plans and other factors. The Company can make no guarantees and actual results
could differ from such plans.
Risks Related to the Year 2000 Issue - Although the Company's Year 2000 efforts
have been intended to minimize the adverse effects of the Year 2000 issue on the
Company's business and operations, the actual effects of the issue and the
success or failure of the Company's efforts described above cannot be known
until the year 2000 occurs. Failure by the Company and its major suppliers,
other material service providers and major distributors to address adequately
their respective Year 2000 issues in a timely manner (insofar as such issues
relate to the Company's business) could have a material adverse effect on the
Company's business, results of operations and financial condition.
10
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
ITEM 3. Quantitative and Qualitative Disclosure About Market Risk
The Company's earnings are affected by fluctuations in the value of the U.S.
dollar, as compared to foreign currencies, as a result of transactions in
foreign markets. At October 31, 1999, the result of a uniform 10% strengthening
or weakening in the value of the dollar relative to the currencies in which the
Company's transactions are denominated would have resulted in an immaterial
increase or decrease in operating income for the three months ended October 31,
1999. This calculation assumes that each exchange rate would change in the same
direction relative to the U.S. dollar. In addition to the direct effects of
changes in exchange rates, which are a changed dollar value of the resulting
sales, changes in exchange rates also affect the volume of sales or the foreign
currency sales price as competitors' services become more or less attractive.
The Company's sensitivity analysis of the effects of changes in foreign currency
exchange rates does not factor in a potential change in sales levels or local
currency prices.
While the Company is exposed to changes in interest rates as a result of its
outstanding debt, the Company does not currently utilize any derivative
financial instruments related to its interest rate exposure. Total short-term
and long-term debt outstanding at October 31, 1999 was $26.5 million, consisting
of $12.2 million in variable rate borrowing and $14.3 million in fixed rate
borrowing. At this level of variable rate borrowing, a hypothetical 10% increase
in interest rates would have decreased pre-tax earnings by approximately $29,000
for the three months ended October 31, 1999. At October 31, 1999, the fair value
of the Company's fixed rate debt outstanding was estimated at $15.0 million. A
hypothetical 10% change in interest rates would not result in a material change
in the fair value of the Company's fixed rate debt.
11
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
PART II - OTHER INFORMATION
ITEM 6. Exhibits and Reports on Form 8-K:
(a) Exhibits:
Exhibit 10.1 Agreement by and between Survival Technology, Inc. and EM
Industries, Inc., dated as of October 21, 1996
Exhibit 10.2 Waiver and Amendment Agreement dated October 29, 1999
between the Company and Nomura Holding America Inc.
Exhibit 10.3 Seventh Amendment to the Credit Agreement dated October
29, 1999 between the Company and ING (U.S.) Capital Corporation.
Exhibit 27 Financial Data Schedule
(b) Reports on Form 8-K:
No reports on Form 8-K were filed during the three months ended October
31, 1999.
12
MERIDIAN MEDICAL TECHNOLOGIES, INC.
FORM 10-Q
SIGNATURES
Pursuant to the requirement 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.
-----------------------------------
Registrant
December 15, 1999 By: /S/ James H. Miller
----------------- ----------------------------------
Date James H. Miller
President and
Chief Executive Officer
(Principal Executive Officer)
December 15, 1999 By: /S/ Dennis P. O'Brien
----------------- ----------------------------------
Date Dennis P. O'Brien
Vice President-Finance
and Chief Financial Officer
(Principal Financial and
Accounting Officer)
13
EXIBIT INDEX
Exhibit No. Description of Exhibit
- ----------- ----------------------
(10.1) Agreement by and between Survival Technology, Inc. and EM
Industries, Inc., dated as of October 21, 1996
(10.2) Waiver and Amendment Agreement dated October 29, 1999 between
the Company and Nomura Holding America Inc.
(10.3) Seventh Amendment to the Credit Agreement dated October 29,
1999 between the Company and ING (U.S.) Capital Corporation.
(27.0) Financial Data Schedule
14