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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-Q
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(MARK ONE)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED APRIL 2, 1999
OR
[ ] 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 0-26268
MINIMED INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 95-4408171
(STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER
INCORPORATED OR ORGANIZATION) IDENTIFICATION NO.)
12744 SAN FERNANDO ROAD, SYLMAR, CA 91342
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (ZIP CODE)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (818) 362-5958
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Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15 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:
TITLE OF EACH CLASS OUTSTANDING AT MAY 12, 1999
------------------ ---------------------------
COMMON STOCK, $.01 PAR VALUE 28,351,696
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INDEX
MINIMED INC.
PAGE
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PART I. FINANCIAL INFORMATION
Item 1. Consolidated Financial Statements and Notes................. 3
Consolidated Balance Sheets -- January 1, 1999 and April 2,
1999 (Unaudited)............................................ 3
Consolidated Statements of Income (Unaudited) -- Three
months ended April 3, 1998 and April 2, 1999................ 4
Consolidated Statements of Cash Flows (Unaudited) -- Three
months ended April 3, 1998 and April 2, 1999................ 5
Notes to Consolidated Financial Statements (Unaudited)...... 6
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations................................... 9
Item 3. Quantitative and Qualitative Disclosures About Market
Risk........................................................ 16
PART II. OTHER INFORMATION
Item 1. Legal Proceedings........................................... 16
Item 2. Changes in Securities and Use of Proceeds................... 16
Item 3. Defaults Upon Senior Securities............................. 17
Item 4. Submission of Matters to a Vote of Security Holders......... 17
Item 5. Other Information........................................... 17
Item 6. Exhibits and Reports on Form 8-K............................ 17
SIGNATURE............................................................ 18
INDEX TO EXHIBITS.................................................... 19
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PART I. FINANCIAL INFORMATION
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS AND NOTES
MINIMED INC.
CONSOLIDATED BALANCE SHEETS
JANUARY 1, 1999 AND APRIL 2, 1999
ASSETS
1998 1999
------------ ------------
(UNAUDITED)
CURRENT ASSETS:
Cash and cash equivalents................................. $ 27,303,000 $ 21,418,000
Short-term investments.................................... 13,476,000 13,482,000
Accounts receivable, net of allowance for doubtful
accounts of $8,844,000 and $8,481,000 at January 1,
1999 and April 2, 1999, respectively................... 38,788,000 40,245,000
Inventories............................................... 16,860,000 17,681,000
Deferred income taxes..................................... 6,404,000 6,485,000
Prepaid expenses and other current assets................. 3,835,000 7,082,000
------------ ------------
Total current assets.............................. 106,666,000 106,393,000
NOTE RECEIVABLE FROM AFFILIATE.............................. 3,600,000 3,600,000
LONG-TERM INVESTMENTS....................................... 4,826,000 5,140,000
OTHER ASSETS................................................ 11,522,000 11,367,000
LAND, BUILDINGS, PROPERTY AND EQUIPMENT -- Net.............. 31,038,000 34,400,000
------------ ------------
TOTAL ASSETS................................................ $157,652,000 $160,900,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Current portion of notes payable and line of credit....... 1,101,000 882,000
Accounts payable.......................................... 5,447,000 5,747,000
Accrued salaries and related benefits..................... 5,231,000 3,838,000
Accrued sales commissions................................. 2,260,000 573,000
Accrued warranties........................................ 2,828,000 2,885,000
Income taxes payable...................................... 1,155,000 2,014,000
Other accrued expenses.................................... 3,873,000 2,955,000
------------ ------------
Total current liabilities......................... 21,895,000 18,894,000
------------ ------------
Deferred Tax Liabilities.................................. 865,000 984,000
Notes payable............................................. 1,059,000 1,000,000
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Common stock, par value $.005; 40,000,000 shares
authorized; 28,095,274 and 28,207,356 shares issued and
outstanding as of January 1, 1999 and April 2, 1999,
respectively........................................... 143,000 147,000
Additional capital........................................ 111,826,000 114,088,000
Accumulated other comprehensive income.................... 738,000 879,000
Retained earnings......................................... 21,126,000 24,908,000
------------ ------------
Total stockholders' equity........................ 133,833,000 140,022,000
------------ ------------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY.................. $157,652,000 $160,900,000
============ ============
See notes to consolidated financial statements.
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MINIMED INC.
CONSOLIDATED STATEMENTS OF INCOME
THREE MONTHS ENDED APRIL 3, 1998 AND THREE MONTHS ENDED APRIL 2, 1999
1998 1999
----------- -----------
(UNAUDITED)
NET SALES................................................... $26,366,000 $40,911,000
COST OF SALES............................................... 9,784,000 13,838,000
----------- -----------
GROSS PROFIT................................................ 16,582,000 27,073,000
=========== ===========
OPERATING EXPENSES:
Selling, general and administrative......................... 11,391,000 17,499,000
Research and development.................................... 3,317,000 5,296,000
Research and development contract income.................... (1,500,000) (1,500,000)
----------- -----------
Total operating expenses.......................... 13,208,000 21,295,000
=========== ===========
OPERATING INCOME............................................ 3,374,000 5,778,000
OTHER INCOME, Including interest income..................... 291,000 294,000
----------- -----------
INCOME BEFORE INCOME TAXES.................................. 3,665,000 6,072,000
PROVISION FOR INCOME TAXES.................................. 1,361,000 2,290,000
----------- -----------
NET INCOME.................................................. $ 2,304,000 $ 3,782,000
=========== ===========
BASIC EARNINGS PER SHARE.................................... $ 0.09 $ 0.13
=========== ===========
BASIC WEIGHTED AVERAGE SHARES OUTSTANDING................... 26,562,000 28,148,000
=========== ===========
DILUTED EARNINGS PER SHARE.................................. $ 0.08 $ 0.13
=========== ===========
DILUTED WEIGHTED AVERAGE SHARES OUTSTANDING................. 27,854,000 30,024,000
=========== ===========
See notes to consolidated financial statement.
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MINIMED INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
THREE MONTHS ENDED APRIL 3, 1998 AND THREE MONTHS ENDED APRIL 2, 1999
1998 1999
----------- -----------
(UNAUDITED)
CASH FLOWS FROM OPERATING ACTIVITIES --
Net income.................................................. $ 2,304,000 $ 3,782,000
Adjustments to reconcile net income to net cash provided by
(used in) operating activities:
Depreciation and amortization............................. 1,053,000 1,560,000
Directors fees paid in common stock....................... -- 32,000
Deferred income taxes..................................... (558,000) (81,000)
Tax benefit from exercise of non-qualified stock
options................................................ -- 1,630,000
Changes in operating assets and liabilities:
Accounts receivable, net............................... 1,477,000 (1,457,000)
Inventories............................................ (1,602,000) (821,000)
Prepaid expenses and other current assets.............. 384,000 (3,247,000)
Other assets........................................... (47,000) 35,000
Accounts payable....................................... (2,495,000) 300,000
Income taxes payable................................... 1,438,000 859,000
Accrued expenses....................................... (5,153,000) (3,941,000)
----------- -----------
Net cash used in operating activities.................. (3,199,000) (1,349,000)
----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES --
Short-term investments.................................... 14,081,000 (6,000)
Acquisition of Dartec A.B................................. (2,544,000) --
Purchase of land, buildings, property and equipment....... (3,393,000) (4,724,000)
----------- -----------
Net cash provided by (used in) investing activities....... 8,144,000 (4,730,000)
----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES --
Repayment of notes payable................................ (2,811,000) (278,000)
Proceeds from stock option exercises...................... -- 525,000
----------- -----------
Net cash provided by (used in) financing activities....... (2,811,000) 247,000
----------- -----------
Effect of foreign exchange rates on cash.................. 147,000 (53,000)
NET INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS............................................... 2,281,000 (5,885,000)
CASH AND CASH EQUIVALENTS, BEGINNING OF
PERIOD.................................................... 22,282,000 27,303,000
----------- -----------
CASH AND CASH EQUIVALENTS, END OF PERIOD.................... $24,563,000 $21,418,000
=========== ===========
SUPPLEMENTAL CASH FLOW INFORMATION --
Cash paid during the period for:
Interest.................................................. $ 35,000 $ 2,000
Income taxes.............................................. $ 461,000 $ 265,000
SUPPLEMENTAL DISCLOSURE OF NONCASH FINANCING ACTIVITY -- The Company recorded an
unrealized holding gain of $195,000 during the three months ended April 2, 1999
and an unrealized holding loss of $997,000 during the three months ended April
3, 1998, net of estimated income taxes on marketable securities classified as
long-term investments available for sale.
See notes to consolidated financial statements.
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MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
THREE MONTHS ENDED APRIL 3, 1998 AND THREE MONTHS ENDED APRIL 2, 1999
The fiscal years referenced herein are as follows:
FISCAL YEAR YEAR ENDED
----------- -----------------
1999............................................. December 31, 1999
1998............................................. January 1, 1999
NOTE 1. BASIS OF PRESENTATION
The accompanying unaudited financial statements of MiniMed Inc. (the
"Company" or "MiniMed") have been prepared in accordance with generally accepted
accounting principles for interim financial information and with the
instructions to Form 10-Q and Regulation S-X. Accordingly, they do not include
all of the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management, all
normal, recurring adjustments considered necessary for a fair presentation have
been included. The financial statements should be read in conjunction with the
audited financial statements included in the Annual Report of MiniMed filed on
Form 10-K with the Securities and Exchange Commission for the year ended January
1, 1999. The results of operations for the three months ended April 2, 1999 are
not necessarily indicative of the results that may be expected for the fiscal
year ending December 31, 1999.
On March 15, 1999, the Company announced a 2-for-1 stock split, in the form
of a stock dividend, to holders of record of MiniMed's common stock at the close
of business on April 1, 1999. In accordance with SFAS 128, "Earnings per Share,"
the Company has recorded the effects of this stock split on share and per share
amounts at April 2, 1999 and all prior periods have been restated.
NOTE 2. INCOME TAXES
Net income and earnings per share for the three months ended April 3, 1998
and April 2, 1999 reflect income taxes which have been recorded at the Company's
estimated effective tax rate for the year. This estimated income tax rate has
been determined by giving consideration to the pretax earnings and losses
applicable to foreign and domestic tax jurisdictions.
NOTE 3. WEIGHTED AVERAGE NUMBER OF COMMON AND COMMON EQUIVALENT SHARES
OUTSTANDING
In accordance with Statement of Financial Accounting Standards No. 128,
"Earnings Per Share" (SFAS 128), basic earnings per share for the three months
ended April 3, 1998 and April 2, 1999, were computed by dividing net income by
weighted average common shares outstanding during the periods presented. Diluted
earnings per share for the periods presented were computed by dividing net
income by weighted average common and common equivalent shares outstanding,
computed in accordance with the treasury stock method. The computation of basic
and diluted EPS is as follows:
THREE MONTHS ENDED THREE MONTHS ENDED
APRIL 3, 1998 APRIL 2, 1999
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BASIC EPS COMPUTATION
Numerator:
Net income applicable to common stock........... $ 2,304,000 $ 3,782,000
Denominator:
Weighted average common shares outstanding...... 26,562,000 28,148,000
----------- -----------
Basic earnings per share........................ $ 0.09 $ 0.13
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MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
THREE MONTHS ENDED APRIL 3, 1998 AND THREE MONTHS ENDED APRIL 2, 1999
THREE MONTHS ENDED THREE MONTHS ENDED
APRIL 3, 1998 APRIL 2, 1999
------------------ ------------------
DILUTED EPS COMPUTATION
Numerator:
Net income applicable to common stock........... $ 2,304,000 $ 3,782,000
----------- -----------
Denominator:
Weighted average common shares outstanding...... 26,562,000 28,148,000
Effect of dilutive securities:
Stock options................................. 1,292,000 1,876,000
----------- -----------
Diluted weighted average shares outstanding..... 27,854,000 30,024,000
----------- -----------
Diluted earnings per share...................... $ 0.08 $ 0.13
=========== ===========
NOTE 4. CONSOLIDATED BALANCE SHEET COMPONENTS
Certain balance sheet components are as follows:
JANUARY 1, APRIL 2,
1999 1999
----------- ------------
(UNAUDITED)
Inventories:
Raw materials.................................. $ 7,064,000 $ 7,672,000
Work-in-progress............................... 3,040,000 2,328,000
Finished Goods................................. 6,756,000 7,681,000
----------- ------------
$16,860,000 $ 17,681,000
=========== ============
Property, plant and equipment:
Land, buildings and improvements............... $13,244,000 $ 14,500,000
Machinery and equipment........................ 17,332,000 18,845,000
Tooling and molds.............................. 2,352,000 2,359,000
Computer software.............................. 1,989,000 2,682,000
Furniture and fixtures......................... 5,301,000 6,569,000
----------- ------------
40,218,000 44,955,000
Less accumulated depreciation.................... (9,180,000) (10,555,000)
----------- ------------
Total............................................ $31,038,000 $ 34,400,000
=========== ============
Other assets:
Technology license............................. $ 145,000 $ 133,000
Goodwill....................................... 11,114,000 10,994,000
Other.......................................... 263,000 240,000
----------- ------------
Total............................................ $11,522,000 $ 11,367,000
=========== ============
Long-term investments:
Investment in Trimeris common stock -- at fair
value....................................... $ 3,686,000 $ 4,000,000
Investment in PDC common stock -- at cost...... 1,140,000 1,140,000
----------- ------------
Total............................................ $ 4,826,000 $ 5,140,000
=========== ============
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MINIMED INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (CONTINUED)
THREE MONTHS ENDED APRIL 3, 1998 AND THREE MONTHS ENDED APRIL 2, 1999
NOTE 5. COMPREHENSIVE INCOME
The Company's total comprehensive income was as follows:
THREE MONTHS ENDED
------------------------------
APRIL 3, 1998 APRIL 2, 1999
------------- -------------
Net income.................................................. $2,304,000 $3,782,000
Other comprehensive income (loss):
Foreign currency translation adjustments.................. 147,000 (54,000)
Unrealized gain (loss) on securities...................... (1,608,000) 314,000
---------- ----------
Other comprehensive income (loss), before income taxes.... (1,461,000) 260,000
Income tax expense (benefit) related to items of other
comprehensive income (loss)............................ (611,000) 119,000
---------- ----------
Other comprehensive income (loss)......................... (850,000) 141,000
---------- ----------
Total comprehensive income.................................. $1,454,000 $3,923,000
========== ==========
NOTE 6. COMMITMENTS AND CONTINGENCIES
On September 11, 1996, the Company filed an action against Fimed, Inc.
("Fimed") seeking rescission of a product distribution contract. Subsequent to
the filing of this action, Fimed filed a counterclaim seeking compensatory
damages of approximately $400 million plus punitive damages. The Company
believes that it has meritorious defenses to the counterclaims asserted by
Fimed. The Court appointed a retired Judge to act as an Independent Expert
pursuant to California law to evaluate, assuming liability, the amount of
damages, if any, sustained by Fimed. The hearing on this matter was held in
February 1999. Fact discovery pertaining to the litigation has been largely
completed. Trial in this matter is currently set to commence September 1999. The
Company has been pursuing its claims and is defending against Fimed's claims
vigorously.
During 1998, the Company integrated the operations of Home Medical Supply,
Inc. and its affiliated companies ("HMS"), which the Company acquired in fiscal
1997. In connection with these activities, the Company discovered certain
business practices relating to charges billed to the State of Florida for health
care services provided through an affiliated pharmacy. These practices were
implemented by HMS' prior owners and may potentially result in liability to the
Company. The Company has received no notice of any action which is pending or
threatened against it in connection therewith. The Company has corrected such
practices, notified the State of Florida authorities of its findings, initiated
legal action against the prior owners to seek indemnification for any such
liability and is pursuing other legal remedies. The amount of liability to the
Company, if any, cannot be determined at this time, although the Company
believes that indemnification for such liability would be available from HMS'
prior owners.
On February 9, 1999, the Company was served with a complaint, filed in
Louisiana, by Diabetes Resources, Inc. (d/b/a Insulin Infusion Specialties)
("IIS"), a former authorized distributor for MiniMed products, alleging various
causes of action against the Company. IIS entered into an Educational Dealer
Agreement (the "Agreement") with MiniMed in July 1997. MiniMed elected to not
renew the Agreement and the Agreement expired pursuant to its terms as of
December 31, 1998. IIS is alleging that MiniMed engaged in unfair competition,
breached the Agreement, violated applicable trade secret laws and defamed IIS.
IIS did not specify the amount of damages it is seeking in its complaint. On
April 6, 1999, the Company filed a counterclaim alleging IIS breached the
Agreement and carried on various unfair trade practices. The Company believes
that its counterclaims and its defenses to the claims asserted by IIS are
meritorious. Discovery in this litigation is in its preliminary stages.
During the normal course of business, the Company may be subject to
litigation involving various business matters. Management believes that an
adverse outcome of any such known matters would not have a material adverse
impact on the Company.
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion of the financial condition and results of
operations of MiniMed Inc. ("MiniMed" or the "Company") should be read in
conjunction with the consolidated financial statements and the related notes
thereto incorporated by reference herein. Any statements contained herein
regarding MiniMed that are forward looking, including statements relating to
anticipated operating results, growth, financial resources, capital
requirements, adequacy of the Company's capital resources, trends in spending on
research and development, the development of new markets, the development,
regulatory approval, manufacture, distribution, and commercial acceptance of new
products and new applications for MiniMed's existing product lines are made
pursuant to the Safe Harbor provisions of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned that forward-looking statements
involve risks and uncertainties which may affect the Company's business and
prospects, including changes in economic and market conditions, acceptance of
MiniMed's products by the health care and reimbursement communities, health care
legislation and regulation, new developments in diabetes therapy, administrative
and regulatory approval and related considerations, competitive developments,
maintenance of strategic alliances and other factors discussed in the Company's
filings with the Securities and Exchange Commission.
GENERAL
The Company's sales and profits have been generated primarily through the
sale of external pumps and related disposable products used to deliver insulin
in the intensive management of diabetes. Additionally, through its acquisitions
of HMS and Dartec in fiscal 1997 and Diabetes Support Systems, Inc. ("DSS") in
fiscal 1998, the Company has broadened its product offerings to its customers to
include other diabetes supplies and pharmacy products generally used in the
treatment of this disease. The Company distributes these products nationally.
Product development and manufacturing operations have focused on three
product lines: external insulin pumps and related disposables, implantable
insulin pumps and continuous glucose monitoring systems. Future development of
the external pump and disposable product line will focus upon improving the
existing technology for its current use in diabetes treatment and the
utilization of this technology for the treatment of other medical conditions.
There have been no sales of glucose monitoring systems to date; however, on
February 26, 1999, the Company received a unanimous recommendation for approval
of the first generation of that product from an Advisory Panel to the Food and
Drug Administration ("FDA") subject to certain conditions. The Company intends
to initiate sales activity for this product line after final FDA approval is
received. The Company's continuous glucose monitoring system's technology has
been characterized as a first of its kind, and commercialization will be subject
to successful implementation of manufacturing, sales, marketing and
reimbursement plans. Management anticipates that this will occur by mid-1999. On
September 1, 1998, the Company sold assets and transferred technology related to
its implantable pump program to Medical Research Group, LLC ("MRG"). The Company
has retained exclusive distribution rights to the implantable pump product line
for specific medical conditions, including diabetes. Sales of the implantable
pump have been and will continue to be irregular until full regulatory approval
is obtained.
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RESULTS OF OPERATIONS
The following table sets forth, for the three months ended April 2, 1999
and the three months ended April 3, 1998, the percentage relationship to net
sales of certain items in the Company's consolidated statements of operations
and the percentage changes in the dollar amounts of such items on a comparative
basis.
PERCENTAGE OF NET SALES
------------------------------
THREE MONTHS THREE MONTHS PERCENTAGE
ENDED ENDED INCREASE
APRIL 2, 1999 APRIL 3, 1998 (DECREASE)
------------- ------------- ----------
Net sales.............................................. 100.0% 100.0% 55.2%
Cost of sales.......................................... 33.8 37.1 41.4
----- ----- ----
Gross profit........................................... 66.2 62.9 63.3
Operating expenses
Selling, general and administrative.................. 42.8 43.2 53.6
Research and development............................. 12.9 12.6 59.7
Research and development contract revenue............ (3.7) (5.7) 0
----- ----- ----
Total operating expenses..................... 52.0 50.1 61.2
----- ----- ----
Operating income....................................... 14.2% 12.8% 71.3%
===== ===== ====
The following table sets forth domestic and international net sales and
gross profits related to the Company's primary product lines for the three
months ended April 2, 1999 and for the three months ended April 3, 1998.
DOLLARS IN THOUSANDS % OF NET SALES
------------------------------ ------------------------------
THREE MONTHS THREE MONTHS THREE MONTHS THREE MONTHS
ENDED ENDED ENDED ENDED
APRIL 2, 1999 APRIL 3, 1998 APRIL 2, 1999 APRIL 3, 1998
------------- ------------- ------------- -------------
DIABETES PRODUCTS:
External pumps and related
disposables
Domestic......................... $34,275 $19,336 83.8% 73.3%
International.................... 3,436 2,756 8.4 10.5
------- ------- ----- -----
Subtotal.................... 37,711 22,092 92.2 83.8
Implantable insulin pumps........... 147 221 0.4 0.8
Other diabetes supplies............. 1,882 1,020 4.6 3.9
------- ------- ----- -----
Total diabetes products..... 39,740 23,333 97.2 88.5
Pharmacy products................... 1,171 3,033 2.8 11.5
------- ------- ----- -----
Total net Sales............. $40,911 $26,366 100.0% 100.0%
======= ======= ===== =====
GROSS PROFITS
Diabetes products:
External pumps and related
disposables...................... $26,378 $15,966 64.5% 60.6%
Implantable pumps................... (199) (596) (0.5) (2.3)
Other diabetes supplies............. 502 491 1.2 1.9
------- ------- ----- -----
Total diabetes products..... 26,681 15,861 65.2 60.2
Pharmacy products................... 392 721 1.0 2.7
------- ------- ----- -----
Total gross profits......... $27,073 $16,582 66.2% 62.9%
======= ======= ===== =====
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THREE MONTHS ENDED APRIL 2, 1999 AND APRIL 3, 1998
NET SALES
Net sales increased 55.2% during the three months ended April 2, 1999 over
the three months ended April 3, 1998 to $40,911,000 from $26,366,000. This
increase is primarily the result of an increase of 70.7%, or $15,619,000 in the
sales volume of external pumps and related disposables. Domestic sales of these
products grew 77.3% or $14,939,000 in the first quarter of 1999 as compared to
the first quarter of 1998, while international sales increased 24.7% or $680,000
during the same period. The domestic net sales growth was derived primarily from
increased volume of external pumps and related disposables combined with an
increase in average prices realized on external pump sales. The higher domestic
external pump price resulted from an increase in the list price for the latest
generation external pump during the second quarter of 1998, combined with the
continued shift of sales by the Company through its direct sales organization
rather than through its independent dealers, which receive discounts on these
products. International sales of external pumps and related disposable products
grew primarily due to greater sales volumes of external pumps, while pricing of
external pumps in the international market remained consistent with the
comparable quarter of 1998. Domestic and international pricing for disposable
products did not change materially from the first quarter of 1998 to the first
quarter of 1999.
Sales of implantable pumps decreased 33.5% or $74,000 from the first
quarter of 1998 to the first quarter of 1999, as regulatory approval for the
implantable pump and special insulin utilized in the implantable system is still
pending. Although the Company received certification under the applicable
directives issued by the European Union (the "EU") and received the CE Mark in
March 1995 for the implantable pump (permitting commercial sale throughout the
EU), separate approval from the EU is required for commercial sale of the
insulin. No assurance can be given as to when such approval will be received, if
at all. Sales of implantable pumps to date have been generated mainly in
connection with clinical trials and compassionate use of the pumps. The
implantable pump and the special insulin remain subject to regulatory review and
approval in the United States. No assurance can be given as to when such
approvals will be received, if at all.
Sales of other diabetes supplies increased by 84.5% or $862,000 during the
1999 first quarter compared to the 1998 first quarter. This increase resulted
from overall market growth combined with the addition of sales of these products
by DSS, which was acquired by the Company during the fourth quarter of 1998.
Average sales prices have decreased for these products due to reimbursement
trends. Pharmaceutical product sales decreased 61.4% or $1,862,000 during the
1999 first quarter compared to the 1998 first quarter. The pharmacy operation
historically distributed products to treat a number of medical conditions,
including diabetes, HIV/ AIDS and renal failure. The 1999 sales decrease
resulted primarily from the Company's continued narrowing and restructuring of
the pharmacy operations to better support MiniMed's current activities and to
better position the Company for future opportunities.
OPERATING RESULTS
Cost of Sales and Gross Profits -- Cost of sales increased 41.4% during the
three months ended April 2, 1999 over the three months ended April 3, 1998 to
$13,838,000 from $9,784,000. As a percentage of net sales, cost of sales in the
1999 first quarter decreased to 33.8% from 37.1% in the comparable period of
1998. Gross margins on external pumps and disposables decreased to 69.9% of such
sales during the 1999 first quarter, compared to 72.3% for this product line
during the 1998 first quarter. The decline in gross margins on these products is
primarily the result of increased spending to identify alternate supply channels
of raw material components used in the Company's external pumps and to certify
vendors for MiniMed's quality criteria. The effects of this increased spending
on vendor identification and certification on external pump gross margins was
partially offset by an increase in average selling prices for external pumps.
Disposable gross margins were consistent between the first quarter of 1998 and
the first quarter of 1999. The Company has continued to purchase certain
disposable products from a contract manufacturer rather than manufacturing these
products through its internal manufacturing operations.
The Company's gross profits continue to be adversely impacted by the
implantable pump product line due to continued limited sales prior to full
commercial release. However, implantable pump gross margins
11
12
improved during the 1999 first quarter compared to the comparable period in 1998
due to the transfer of implantable pump manufacturing operations to Medical
Research Group, Inc. ("MRG") on September 1, 1998. The Company expects this
improvement in margins to continue in the short-term as a result of the MRG
transaction; however, long-term margins may be reduced due to the transfer of
the manufacturing operation to MRG, as MiniMed's role has been converted to an
exclusive distributor of this product. MiniMed is required to purchase
implantable pump units from MRG at negotiated prices, is obligated to purchase
minimum quantities in 1999, 2000 and 2001 and must purchase minimum quantities
in future periods in order to preserve its exclusivity. Future minimum purchase
commitments for implantable pump units based upon current prices are:
1999............................................ $ 3,980,000
2000............................................ 7,604,000
2001............................................ 8,935,000
-----------
Total........................................... $20,519,000
===========
Gross margins for other diabetes supplies decreased to 26.7% of such sales
during the first quarter of 1999 compared to 48.1% of such sales during the
comparable period in 1998. This decrease was due to the continued effects of
lower average sales prices due to reimbursement trends. Gross profits on
pharmaceutical products decreased 45.6% to $392,000 during the first quarter of
1999, compared to $721,000 during the first quarter of 1998. This decrease was
primarily due to the continued restructuring of the pharmacy operations as
described above. Gross margins on pharmaceutical products, however, as a
percentage of such sales, increased to 33.5% during the first quarter of 1999
compared to 23.8% during the first quarter of 1998.
Operating Expenses -- Selling, general and administrative expenses
increased 53.6% during the three months ended April 2, 1999 over the three
months ended April 3, 1998 to $17,499,000 from $11,391,000. As a percentage of
net sales, these expenses decreased to 42.8% during the 1999 first quarter from
43.2% during the 1998 first quarter. Selling and marketing expenses increased
primarily due to increased sales volumes, which led to increased sales
commissions and other variable field sales costs. Also, the Company continued to
increase expenditures to expand its overall international presence, particularly
in Germany. General and administrative expenses also rose during the three
months ended April 2, 1999 over the three months ended April 3, 1998 due to
costs associated with staff increases necessary to support the Company's
increased business activities.
Research and development expenses grew 59.7% during the three months ended
April 2, 1999 over the three months ended April 3, 1998 to $5,296,000 from
$3,317,000. As a percentage of sales, research and development expenses
increased to 12.9% during the three months ended April 2, 1999 from 12.6% during
the comparable period in 1998. The 1999 first quarter increase in research and
development costs resulted from greater resources directed to the development of
continuous glucose monitoring systems, start-up manufacturing operations of the
continuous glucose monitoring systems, development of future generation external
insulin pumps and related disposable products and data communication
capabilities for external pumps and continuous glucose monitoring systems. The
Company anticipates that research and development expenditures for future
periods will continue to increase as more of its new technological innovations
approach commercialization.
During the 1998 first quarter, the Company signed a research and
development contract with American Medical Instruments, Inc. ("AMI"), a member
of The Marmon Group of Companies. Under terms of the agreement, and subject to
the achievement of quarterly performance milestones, the Company can receive up
to $12.0 million in funding, payable in quarterly installments of $1.5 million,
for two research and development projects. Subject to payment of royalties to
AMI, the Company will have the right to sell products utilizing the technology
developed pursuant to the agreement on a world-wide basis, with the exception of
Japan. The Company also has the right to purchase the technologies developed at
prices ranging from an aggregate of $13.5 million to $19.0 million during
certain periods through April 30, 2002. During each of the first quarter 1998
and 1999, the Company recorded $1.5 million from this research and development
contract as a reduction of operating expenses, as costs related to completion of
the contractual obligations will be included in research and development
expense.
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Other -- During the three months ended April 2, 1999 and the three months
ended April 3, 1998, other income consisted primarily of interest income
generated from the Company's cash, cash equivalents, and short-term investment
balances.
The Company's effective tax rate during the three months ended April 2,
1999 and April 3, 1998 has been computed giving consideration to the pretax
earnings and losses applicable to the Company's foreign and domestic tax
jurisdictions. Inflation has not significantly impacted the Company's results of
operations for the past two years.
LIQUIDITY AND CAPITAL RESOURCES
The Company used cash in operations of $1,349,000 and $3,199,000 during the
three months ended April 2, 1999 and the three months ended April 3, 1998,
respectively. Cash flow from operations improved during the first quarter of
1999 compared to the first quarter of 1998 primarily due to a reduction in cash
expenditures on various accounts payable and accrued expenses. During the first
quarter of 1998, the Company used cash to retire approximately $3,356,000 in
current liabilities related to the HMS acquisition. The improvement in operating
cash flow in the first quarter of 1999 was partially offset by increases in
inventory and accounts receivable balances during such period. The Company has
begun to increase finished goods inventory levels to support the historically
higher sales volumes experienced in the third and fourth quarters. Additionally,
the Company experienced a significant increase in accounts receivable caused
primarily by the Company's continuing shift to selling direct to patients
through its in-house sales organization rather than through independent dealers.
This sales shift has led to a significant increase in accounts receivable
balances due from third party payors, which are generally realized over a longer
payment cycle.
The increase in capital expenditures in the first quarter of 1999 to
$4,724,000 compared to $3,393,000 spent during the comparable period in 1998,
resulted primarily from building glucose sensor manufacturing capacity, as well
as other building improvements to service growth, manufacturing expansion,
research and development engineering equipment, information systems requirements
and some initial outlays for the new corporate headquarters. The Company
anticipates that future capital expenditures will continue to increase to
support the Company's new product activities and to build the infrastructure
necessary to accommodate the Company's anticipated growth. During the first
quarter of 1998, the Company used approximately $2.5 million of cash to complete
its acquisition of Dartec A.B., a Scandinavian distributor. The Company also
used cash of approximately $2.8 million and $278,000 to retire some existing
debt related to the HMS operations during the first quarter of 1998 and the
first quarter of 1999, respectively.
The Company is finalizing a financing transaction pursuant to which it will
construct a corporate headquarters, research and development and manufacturing
facility on the campus of California State University, Northridge, the first
phase of which will be financed with a $65.0 million credit transaction. The
Company expects the transaction to be structured as a synthetic lease financing
for this facility and, in a related transaction, is obtaining a revolving line
of credit to borrow up to $15 million. In connection with these financing
transactions, the Company will pledge substantially all of its assets as
collateral security, and to be subject to various affirmative and negative
covenants regarding the conduct of its business. These arrangements could
adversely affect the Company's ability to obtain additional capital or acquire
additional capital resources. The synthetic lease will have a term of five
years, with two one-year renewal options. The underlying ground lease has a term
of 40 years with renewal options for up to an additional 40 years. Under these
arrangements, the Company will be committed to annual payments ranging from $4.5
million to $5.0 million commencing sometime during the second half of 2000.
Additionally, the Company is committed to payments of $400,000 during 1999 and
to average annual payments in future periods of approximately $450,000, plus
periodic cost of living adjustments, per the terms of the ground lease for the
Northridge property. These lease payments will be recorded as rent expense in
future periods.
Management expects that the current level of cash and cash equivalents will
be sufficient to meet its needs for working capital and capital expenditures for
at least one year. However, the requirements for additional capital and working
capital are subject to change and will depend upon numerous factors, including
the level of capital expenditures, research and development activities and
results, competitive and technologi-
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cal developments, health care reimbursement trends, and the availability for
acquisition by the Company of complementary additional distribution channels,
products, and technologies, and the development of the next phase of the
Company's facilities.
YEAR 2000 COMPLIANCE
The Year 2000 problem ("Y2K") refers to the potential of all electronic
devices containing microprocessors to improperly calculate dates in and beyond
the year 2000. In the second quarter of 1998, the Company formed a Year 2000
Oversight Committee (the "Committee") to evaluate the Company's position
regarding Y2K. The Committee consists of members representing all of the major
operating and administrative departments within the Company including
information technology, facilities, manufacturing, research and development,
regulatory, quality assurance, materials, finance and accounting and legal.
The Committee established an Action Plan Program (the "Plan") to facilitate
the Company's Y2K compliance and minimize the potential effects of Y2K on the
Company's operations. The components of the plan include the following steps:
(1) assess Y2K compliance of the Company's products; (2) inventory Company
equipment and software (including non-information systems equipment and
software) and prioritize according to critical business functions; (3) implement
Y2K compliance testing and remediation according to priorities developed; (4)
assess vendor and health care payor compliance; (5) develop and implement
policies to maintain Y2K compliance going forward; and (6) establish contingency
plans. A timetable for the completion of each of these action steps contained in
the Plan has been developed by the Committee. The Committee meets regularly to
assess the Company's efforts to comply with the Plan and to address any
outstanding Y2K issues. The Committee is also responsible for coordinating all
communications and responding to all inquiries relating to Y2K.
The Company has completed its evaluation of all of its current product
offerings. Such evaluation has shown that Y2K will not pose operating problems
for such products. In the first quarter of 1999 the Company completed the
process of creating a master inventory of all equipment and software vulnerable
to Y2K and is identifying the equipment and software attendant to critical
business processes. Once this process is complete, the Company will be in a
position to implement remediation programs to address potential problems that
are identified. The Company has also begun to remediate certain non-compliant
systems including certain manufacturing systems, information technology systems,
communication systems, security systems and personal computers. The Company
currently believes that it will be able to modify, replace, or mitigate its
affected systems in time to avoid any material impact on its operations.
The Company has initiated formal communication with its vendors to assess
their compliance with Y2K. Questionnaires have been developed and distributed to
vendors. Such questionnaires, when returned by a vendor, have been evaluated to
assess the Y2K risk presented by such vendor. On site evaluations at the most
critical vendors' sites of operations are currently being conducted. The Company
suspects that its greatest Y2K risk will be vendor compliance. The Company
relies on its vendors to supply it with critical components necessary for the
manufacture of its products. A program to assess the Y2K compliance of insurance
companies, management service organizations, and other third party payors is
also being implemented. Once both the internal and external reviews described
above are completed, the Company will be able to design a contingency plan to
address its areas of greatest exposure.
The Company's most reasonably likely worst case scenario in the event of a
failure to correct a material Y2K problem could be an interruption in, or
failure of certain normal business activities. Such failures or interruptions
could materially impact the Company's results of operations, liquidity and
financial position. Due to the general uncertainty inherent in the Y2K problem,
resulting primarily from the uncertainty of the Y2K readiness of the Company's
vendors, suppliers and third party payors, the Company is unable to determine at
this time whether the consequences of Y2K failures will have a material adverse
impact on the Company. The Plan, implemented by the Committee, is expected to
significantly reduce both the Company's level of uncertainty about the Y2K
problem and the possibility of significant interruptions to normal operations.
Management currently believes that the cost of Y2K assessment and
remediation will not be material. The Company estimates that the implementation
of the Plan and remediation activities related to the
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15
Company's internal systems and equipment will cost approximately $1,000,000.
Management currently believes that the Company has adequate working capital to
fund these activities.
Readers are cautioned that forward looking statements contained in this
Year 2000 Compliance section should be read in conjunction with the Company's
cautionary language relating to forward-looking statements at the beginning of
Item 2 "Management's Discussion and Analysis of Financial Condition and Results
of Operations," of this quarterly report on Form 10-Q.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not Applicable
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Not Applicable
ITEM 2. CHANGES IN SECURITIES AND USE OF PROCEEDS
The Company has a Stockholder Rights Plan (the "Rights Plan") which is
intended to have the effect of discouraging attempts to obtain control of the
Company. Under the Rights Plan, the Company's stockholders have the right to
purchase a substantial number of additional shares of Common Stock at a price
equal to one-half of the then market price after a person or entity acquires
beneficial ownership of 15% or more of the voting stock of the Company (subject
to certain exceptions) and the acquisition has been publicly announced. The
person or entity acquiring 15% or more of the voting of the stock of the Company
is not entitled to exercise any such rights. As a result, the exercise of the
Rights (as defined in the Rights Plan) would have a substantial dilutive effect
on the voting power and equity investment of that person or entity.
If, after a person or entity acquires 15% or more of the voting stock of
the Company, the acquisition has been publicly announced and thereafter:
(a) the Company merges or consolidates with another entity and the Company
is not the surviving corporation or
(b) the Company merges or consolidates with another entity and is the
surviving corporation but the Common Stock of the Company is converted
into or exchanged for stock or assets of another person or entity or
(c) 50% or more of the Company's assets or earning power is sold or
transferred,
then the Rights become exercisable to purchase shares of the common stock of the
surviving corporation or acquirer at half of its then market price. Until they
become exercisable the Rights are not evidenced by any separate security and
trade with the Common Stock. Until the rights become exercisable to purchase
Common Stock, the Rights are redeemable at the option of the Board of Directors
for nominal consideration and the Board has the right to amend, supplement or
terminate the Rights Plan.
On May 1, 1999, the Company amended its Rights Plan to (a) eliminate those
provisions that require that certain actions may only be taken by 'Independent
Directors' (as defined in the Rights Plan) and (b) to change the exercise price
of a Right (as defined in the Rights Plan) from $65.00 to $250.00. Under the
Rights Plan prior to this amendment, a majority (but not less than three)
'Independent Directors' had the power to take certain actions after the Rights
have become exercisable, including the power to redeem the Rights and to amend
and supplement the Rights Plan in certain respects. 'Independent Directors' were
directors who became directors prior to the time a person or entity acquired
beneficial ownership of 15% or more of the outstanding shares of voting stock of
the Company (subject to certain exceptions) or were recommended to become a
director by such directors and who were not such a 15% stockholder or affiliated
with such a 15% stockholder. In 1998 the Delaware Court of Chancery decided a
case holding that such provisions, which can have the effect of excluding some
or all duly elected directors from voting on the action to be taken, are
invalid. The amendment to the Rights Plan is intended to bring the Rights Plan
into conformance with the court decision. The effect of the amendment is to make
it possible for directors who are elected after a person or entity acquires
beneficial ownership of 15% or more of the outstanding shares of Common Stock
(and who are not recommended by the directors in office before that acquisition
of shares) to redeem the Rights and to amend or supplement the Rights Plan. This
makes it easier for such a 15% stockholder to reduce or eliminate the protection
that the Rights Plan was intended to provide.
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At the 1999 Annual Meeting of Stockholders to be held on May 20, 1999 the
stockholders of the Company will consider amendments to the Company's
Certificate of Incorporation and ByLaws to establish three classes of directors
with each class being elected every three years (after a phase-in period) to
staggered three year terms. With such a classified board, replacement of a
majority of the directors would normally take at least two annual meetings. This
provides some measure of protection against the possibility that the Rights Plan
could be circumvented by newly elected directors redeeming the Rights or
amending or supplementing the Rights Plan that was lost by the elimination of
the Independent Director concept.
The amendment of the Rights Plan to increase the exercise price of the
Rights is intended to take into account changes in the prices at which the
Company's Common Stock have been trading since the Rights Plan was adopted in
1995. Under the Rights Plan each stockholder receives one Right for each share
of Common Stock held by him or her. The number of shares that can be purchased
upon exercise of each Right when it becomes exercisable to purchase Common Stock
is equal to the exercise price divided by one-half of the then current market
price of the Common Stock. Thus the relationship between the exercise price and
the market price of the Common Stock determines the number of shares which can
be purchased upon exercise of the Rights.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not Applicable
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Not applicable
ITEM 5. OTHER INFORMATION
Not applicable.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) EXHIBITS
EXHIBIT
NUMBER EXHIBIT
------- -------
10.1 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Alfred E. Mann.
10.2 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Terrance H. Gregg.
10.3 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Eric S. Kentor.
10.4 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and David Morley.
10.5 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Kevin R. Sayer.
27.1 Financial data schedule
(b) REPORTS ON FORM 8-K
None.
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SIGNATURE
Pursuant to 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.
MiniMed Inc.
Date: May 17, 1999 /s/ KEVIN R. SAYER
--------------------------------------
Kevin R. Sayer
Senior Vice President, Finance &
Chief Financial Officer
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INDEX TO EXHIBITS
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
10.1 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Alfred E. Mann.
10.2 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Terrance H. Gregg.
10.3 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Eric S. Kentor.
10.4 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and David Morley.
10.5 Change of Control Agreement dated March 1, 1999 between
MiniMed Inc. and Kevin R. Sayer.
27.1 Financial data schedule
19