UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended October 31, 1996
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 0-17019
ANGEION CORPORATION
(Exact name of registrant as specified in its charter)
Minnesota 41-1579150
(State of Incorporation) (IRS Employer Identification No.)
Suite 170
3650 Annapolis Lane, Plymouth, MN 55447-5434
(Address of principal (Zip Code)
executive offices)
(612) 550-9388
(Telephone number)
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___.
Common stock, par value $.01 per share: 28,724,957 shares
outstanding as of December 3, 1996
PART I. FINANCIAL INFORMATION
ITEM DESCRIPTION Page(s)
ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS.
Consolidated Balance Sheets (unaudited) - October 31,
1996 and July 31, 1996. 1
Consolidated Statements of Operations (unaudited) 2
- For the Three Months Ended October 31, 1996 and 1995.
Consolidated Statements of Cash Flows (unaudited) 3
- For the Three Months Ended October 31, 1996 and 1995.
Notes to Consolidated Financial Statements (unaudited). 4
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL 5,6
CONDITION AND RESULTS OF OPERATIONS.
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K. 7
Signature. 8
<TABLE>
<CAPTION>
ANGEION CORPORATION
Consolidated Balance Sheets
October 31, 1996 and July 31, 1996
(unaudited)
October 31, July 31,
ASSETS 1996 1996
- ------ ------------ ------------
<S> <C> <C>
Current Assets:
Cash and Cash Equivalents $ 3,477,930 $ 35,183,919
Short-term Investments 33,250,407 7,368,290
Accounts Receivable:
Trade, less allowance for doubtful accounts of
zero and $60,758 1,047,059 2,330,742
Other 252,869 164,009
Inventories 6,011,821 3,949,350
Prepaid Expenses and Other Current Assets 185,073 159,112
------------ ------------
TOTAL CURRENT ASSETS 44,225,159 49,155,422
Property and Equipment, Net 5,075,176 4,819,820
Patents and Trademarks, Net 1,012,301 1,079,785
Other Assets 122,663 128,869
------------ ------------
TOTAL ASSETS $ 50,435,299 $ 55,183,896
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Accounts Payable 1,327,710 2,970,237
Accrued Payroll, Vacation and Related Costs 480,807 607,700
Other Accrued Expenses 702,535 642,280
Deferred Income 731,250 --
------------ ------------
TOTAL CURRENT LIABILITIES 3,242,302 4,220,224
Long-Term Debt 1,500,000 1,500,000
------------ ------------
TOTAL LIABILITIES 4,742,302 5,720,224
------------ ------------
Shareholders' Equity:
Class A Convertible Preferred Stock, $.01 par value
Authorized 1,475,000 shares; issued and outstanding
875,000 shares at October 31, 1996 and July 31, 1996 8,750 8,750
Common Stock, $.01 par value. Authorized
35,000,000 shares; issued and outstanding
28,674,957 shares at October 31, 1996,
and 28,641,707 shares at July 31, 1996 286,750 286,417
Additional Paid-In Capital 91,735,949 91,536,256
Accumulated Deficit (46,338,452) (42,367,751)
------------ ------------
TOTAL SHAREHOLDERS' EQUITY 45,692,997 49,463,672
------------ ------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 50,435,299 $ 55,183,896
============ ============
See accompanying notes to consolidated financial statements.
</TABLE>
ANGEION CORPORATION
Consolidated Statements of Operations
For the Three Months Ended October 31, 1996 and 1995
(Unaudited)
Three Months Ended
October 31
1996 1995
------------ ------------
Net Sales $ 1,723,045 $ 155,330
Operating Expenses:
Manufacturing Expenses 1,617,698 624,873
Research & Development 3,563,124 2,166,656
Selling, General & Administrative 1,032,621 663,819
------------ ------------
Total Operating Expenses 6,213,443 3,455,348
------------ ------------
OPERATING LOSS (4,490,398) (3,300,018)
------------ ------------
Other Income (Expense):
Interest Expense (29,054) (29,322)
Interest Income 548,751 320,775
------------ ------------
Other Income (Expense) 519,697 291,453
------------ ------------
NET LOSS $ (3,970,701) $ (3,008,565)
============ ============
NET LOSS PER SHARE $ (.14) $ (.14)
============ ============
Weighted Average Number of Shares
Outstanding 28,659,707 21,183,561
============ ============
See accompanying notes to consolidated financial statements.
<TABLE>
<CAPTION>
ANGEION CORPORATION
Consolidated Statements of Cash Flows
For the Three Months Ended October 31, 1996 and 1995
(Unaudited)
1996 1995
------------ ------------
<S> <C> <C>
OPERATING ACTIVITIES:
Net Loss $ (3,970,701) $ (3,008,565)
Adjustments to Reconcile Net Loss
to Net Cash Used in Operating Activities:
Depreciation and Amortization 416,582 191,620
Compensation Expense on Grant of Stock and Stock Options 132,403 275,878
Changes in Operating Assets and Liabilities:
Accounts Receivable 1,194,823 (155,282)
Inventories (2,062,471) (437,264)
Prepaid Expenses and Other Current Assets (25,961) 52,340
Accounts Payable (1,642,527) 440,522
Accrued Expenses 664,605 126,607
------------ ------------
Net Cash Used In Operating Activities (5,293,247) (2,514,144)
------------ ------------
INVESTING ACTIVITIES:
Purchase of Short Term Investments (31,032,117) (15,126,632)
Proceeds from Maturities of Short Term Investments 5,150,000 --
Payments for Purchases of Property and Equipment (598,250) (234,715)
Increase in Other Assets -- (92,771)
------------ ------------
Net Cash Used in Investing Activities (26,480,367) (15,454,118)
------------ ------------
FINANCING ACTIVITIES:
Proceeds from Issuance of Common Stock and Warrants, Net -- 20,327,045
Proceeds from Exercise of Stock Options and Warrants 67,625 1,372,256
Repayments of Notes Payable -- (863)
------------ ------------
Net Cash Provided by Financing Activities 67,625 21,698,438
------------ ------------
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (31,705,989) 3,730,176
Cash and Cash Equivalents:
Beginning of Period 35,183,919 2,367,764
------------ ------------
End of Period $ 3,477,930 $ 6,097,940
============ ============
Supplemental disclosure of cash flow information:
Cash paid during the period for interest $ 2,580 $ 2,472
See accompanying notes to consolidated financial statements.
</TABLE>
ANGEION CORPORATION
Form 10-Q
October 31, 1996
Notes to Consolidated Financial Statements
1. BASIS OF PRESENTATION
The unaudited interim consolidated financial statements have been prepared by
the Company in accordance with generally accepted accounting principles,
pursuant to the rules and regulations of the Securities and Exchange
Commission. Accordingly, certain information and footnote disclosures normally
included in financial statements have been omitted or condensed pursuant to
such rules and regulations. The accompanying unaudited interim consolidated
financial statements should be read in conjunction with the consolidated
financial statements and related notes included in the Company's July 31, 1996
Annual Report to Shareholders.
The information furnished reflects, in the opinion of the management of Angeion
Corporation, all adjustments, (of only a normally recurring nature), necessary
to present a fair statement of the results for the interim periods presented.
2. NET LOSS PER SHARE
Net loss per share is computed by dividing the net loss for the period by the
weighted average number of shares of common stock outstanding during the
period. Common equivalent shares representing convertible preferred stock and
common stock warrants and options were excluded in the fiscal 1995 and 1996
periods presented due to their anti-dilutive effect.
3. PUBLIC OFFERINGS
In July 1996, the Company completed a public offering of 4.2 million shares of
newly issued common stock for proceeds of $27,401,887. In March 1996, an
additional $11,630,337 in net proceeds was received from the net exercise of
warrants. On August 2, 1995, the Company completed a public offering of 3.4
million shares of newly issued common stock for proceeds of $20,327,045, net of
expenses. The Company has used and will continue to apply the net proceeds of
the sale of the securities for research and development and leasehold
improvements, and general corporate purposes, including working capital.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS.
The Company's operations consist of the research and development efforts of its
two divisions, the implantable cardioverter defibrillator group and the catheter
ablation group. These divisions are developing medical devices to treat various
types of arrhythmias (irregular heartbeats). Effective November 1, 1995, the
Company established a European subsidiary, Angeion Europe Ltd. ("Angeion
Europe"), to facilitate clinical studies of its implantable cardioverter
defibrillators ("ICDs") and expand its European business activities. For the
same reasons, a German subsidiary, Angeion GmbH, has been established during the
quarter ended October 31, 1996. The results of the subsidiaries' operations are
included in the consolidated financial statements of the Company.
RESULTS OF OPERATIONS
THREE MONTHS ENDED OCTOBER 31, 1996 COMPARED TO THE THREE MONTHS ENDED OCTOBER
31, 1995
Net sales increased from $155,330 in the quarter ended October 31, 1995 to
$1,723,045 in the quarter ended October 31, 1996. The increase was due to the
initiation of sales of defibrillator products, primarily to Pacesetter, Inc., a
subsidiary of St. Jude Medical, and sales in connection with European sales and
U.S. clinical studies. St. Jude Medical, the Company's distribution partner,
recently announced that it intends to acquire Ventritex, Inc., a company that
makes defibrillator products competitive with the Company's products. Although
the full impact of the acquisition, if consummated, is not known at this time,
the Company anticipates that it will eventually result in the dissolution of the
OEM distribution relationship with St. Jude. See "Legal Proceedings" below. The
Company therefore intends to accelerate the development of its own sales force
and begin the process of establishing other distribution relationships.
Nevertheless, until such time as the Company is able to develop fully its own
sales force and establish other distribution relationships, net sales are
expected to grow at a slower rate than originally planned.
Manufacturing expense increased from $624,873 in the quarter ended October 31,
1995 to $1,617,698 in the quarter ended October 31, 1996. The increase was due
to the cost of products sold during the period, as well as start-up costs
associated with the establishment of the Company's manufacturing operations.
Research and development expenses increased from $2,166,656 in the quarter ended
October 31, 1995 to $3,563,124 in the quarter ended October 31, 1996. This
increase was due to an acceleration of research and development activity on the
Sentinel series of implantable cardioverter defibrillators. Research and
development activity related to the development of the Sentinel series accounted
for $3,179,229 of the expense for the quarter ended October 31, 1996, while the
catheter ablation development activities accounted for $383,895 of the expense.
Research and development expenses will continue to increase, reflecting the
Company's intent to move these and other new products through their development
and human clinical studies as rapidly as possible during fiscal 1997.
Selling, general and administrative expense increased from $663,819 in the
quarter ended October 31, 1995 to $1,032,621 in the quarter ended October 31,
1996. This increase was primarily due to an increase in payroll expenses and
initiation of marketing activities related to the Company's transition from a
development stage company to an operating company.
Interest income increased from $320,775 in the quarter ended October 31, 1995 to
$548,751 in the quarter ended October 31, 1996. The increase of $245,976 was due
to higher average invested cash balances in the quarter ended October 31, 1996,
compared to the quarter ended October 31, 1995.
The net loss for the quarter ended October 31, 1996 was $3,970,701, or $.14 per
share, compared to a net loss of $3,008,565, or $.14 per share for the quarter
ended October 31, 1995.
LIQUIDITY AND CAPITAL RESOURCES
The Company's liquidity needs have related to, and are expected to continue to
relate to, expansion of clinical studies, research and development activities of
its ICD and catheter ablation divisions, scale-up and expansion of the Company's
manufacturing and marketing activities, general corporate purposes including
working capital, and the potential acquisition of businesses, products and
technologies. The Company has financed its liquidity needs over the last three
fiscal years through the sale of common stock and other equity securities, and
notes payable.
Net cash used in operating activities was $5,293,247 and $2,514,144 in the
quarters ended October 31, 1996 and 1995, respectively. The cash used during
these periods was primarily related to research and development activities of
the Company's ICD and catheter ablation divisions (including clinical studies)
and, during the quarter ended October 31, 1996, was also related to the build-up
of inventory and increased selling and marketing expenses. These increases were
partially offset by increases in accounts payable and accrued expenses, as the
Company expanded its manufacturing and marketing activities.
The Company's expenditures for fixed assets were $598,250 for the quarter ended
October 31, 1996, and $234,715 for the same period in 1995. Fixed asset
expenditures related primarily to computer equipment, office furniture,
production equipment for the ICD division and research and development
equipment. As the Company expands its ICD production and catheter ablation
research capabilities, fixed asset expenditures are expected to continue to
increase.
At October 31, 1996, the Company had cash and cash equivalents of $3,477,930,
and marketable securities of $33,250,407. In July 1996, the Company completed a
public offering of 4.2 million shares of newly issued common stock for proceeds
of $27,401,887. In March 1996, an additional $11,630,337 in net proceeds was
received from the net exercise of warrants. In August 1995, the Company
completed a public offering of 3.4 million shares of common stock that resulted
in net proceeds of $20,327,045.
The Company may need additional capital depending on a number of factors,
including: progress with clinical studies; time and costs involved in obtaining
regulatory approvals; costs involved in filing, prosecuting and enforcing
patents or defending against patent infringement claims; competing technological
and market developments; costs of manufacturing and marketing scale-up;
potential acquisitions of businesses, products, and technologies and the impact
of the acquisition by St. Jude Medical, the Company's distribution partner, of
Ventritex, Inc. (See discussion below.) There can be no assurance however, that
any required additional capital would be available on acceptable terms, if at
all, and the failure to obtain any additional capital would have a material
adverse effect on the Company.
CERTAIN IMPORTANT FACTORS
This Form 10-Q contains certain forward-looking statements. For this purpose,
any statements contained in this Form 10-Q that are not statements of historical
fact may be deemed to be forward-looking statements. Without limiting the
foregoing, words such as "may," "will," "expect," "believe," "anticipate,"
"estimate," or "continue" or comparable terminology are intended forward-looking
statements. These statements by their nature involve substantial risks and
uncertainties, and actual results may differ materially depending on the variety
of factors, including the following: the expectation that the Company will
continue to incur additional operating losses and net losses over the next few
years and the fluctuation in the Company's operating results; the impact of
competition in the ICD market; new product development cycles and the market
acceptance of the Company's products; the Company's ability to protect its
intellectual property rights and to resolve an intellectual property disputes on
reasonable terms; the Company's ability to meet any obligations that might be
asserted as applicable under, and the impact of the Pacesetter-Ventritex
acquisition on, the previous agreements with Pacesetter, and the ability of the
Company to continue to build its own clinical and distribution networks.
PART II
ITEM 1. LEGAL PROCEEDINGS.
On November 20, 1996, the Company delivered to St. Jude Medical a
formal notice of recission and termination of the OEM Marketing
Agreement and the License Agreement, each dated February 4, 1993
(collectively, the "Agreements"), between the Company and Pacesetter,
Inc., a wholly owned subsidiary of St. Jude Medical ("Pacesetter").
This notice of recission and termination was based, among other
things, on the fact that Pacesetter had fraudulently induced the
Company to enter into the Agreements by failing to disclose that
Pacesetter might have pre-existing obligations to sublicense certain
of the Company's patents to Medtronic, Inc. and that Pacesetter had
materially breached the License Agreement in connection with its
attempt to grant sublicenses in such patents to third parties.
Pacesetter responded to this notice by filing an action in Minnesota
District Court to have the court declare the Agreements to be valid,
enforceable and of full effect and find that Pacesetter is entitled
to reimbursement of approximately $775,000 for overpayments of
product purchases.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibit 27.1 Financial Data Schedule
(b) No Form 8-K was filed during the quarter ended October 31, 1996.
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.
ANGEION CORPORATION
Dated: December 6, 1996 By /s/ David L. Christofferson
------------------------------------
David L. Christofferson
Vice President of Finance (principal
financial and accounting officer)
ANGEION CORPORATION
Exhibit Index to Form 10-Q for the
Quarterly Period Ended October 31, 1996
Item No. Title Method of Filing
- -------- ----- ----------------
27.1 Financial Data Schedule Filed herewith electronically
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<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> JUL-31-1996
<PERIOD-END> OCT-31-1996
<CASH> 3,477,930
<SECURITIES> 33,250,407
<RECEIVABLES> 1,299,928
<ALLOWANCES> 0
<INVENTORY> 6,011,821
<CURRENT-ASSETS> 44,225,159
<PP&E> 7,287,659
<DEPRECIATION> 2,212,483
<TOTAL-ASSETS> 50,435,299
<CURRENT-LIABILITIES> 3,247,302
<BONDS> 0
0
8,750
<COMMON> 286,750
<OTHER-SE> 45,397,497
<TOTAL-LIABILITY-AND-EQUITY> 50,435,299
<SALES> 1,723,045
<TOTAL-REVENUES> 1,723,045
<CGS> 1,617,698
<TOTAL-COSTS> 1,617,698
<OTHER-EXPENSES> 4,595,745
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 29,054
<INCOME-PRETAX> (3,970,701)
<INCOME-TAX> 0
<INCOME-CONTINUING> (3,970,701)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (3,970,701)
<EPS-PRIMARY> (.14)
<EPS-DILUTED> 0
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