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 January 31, 1997
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.)
3650 Annapolis Lane, Suite 170 55447-5434
Plymouth, MN (Zip Code)
(Address of principal
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: 28,764,957 shares
outstanding as of March 10, 1997
PART I. FINANCIAL INFORMATION
ITEM DESCRIPTION Page(s)
- ---- ----------- -------
1. FINANCIAL STATEMENTS.
Consolidated Balance Sheets (unaudited) 1
- January 31, 1997 and July 31, 1996.
Consolidated Statements of Operations (unaudited) 2
- For the Three and Six Months Ended
January 31, 1997 and 1996.
Consolidated Statements of Cash Flows (unaudited) 3
- For the Six Months Ended January 31, 1997 and 1996.
Notes to Consolidated Financial Statements (unaudited). 4
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS. 5-7
PART II. OTHER INFORMATION
1. LEGAL PROCEEDINGS. 8
4. SUBMISSION OF MATTERS TO A VOTE OF
SECURITY HOLDERS. 8-9
6. EXHIBITS AND REPORTS ON FORM 8-K. 9
Signatures. 10
<TABLE>
<CAPTION>
ANGEION CORPORATION
Consolidated Balance Sheets
January 31, 1997 and July 31, 1996
(unaudited)
January 31, July 31,
1997 1996
ASSETS ------------ ------------
<S> <C> <C>
Current Assets:
Cash and Cash Equivalents $ 790,955 $ 35,183,919
Short-Term Marketable Securities 14,848,506 7,368,290
Accounts Receivable:
Trade, less allowance for doubtful accounts of
zero and $60,758 1,202,512 2,330,742
Other 180,499 164,009
Inventories 8,093,629 3,949,350
Prepaid Expenses and Other Current Assets 605,492 159,112
------------ ------------
TOTAL CURRENT ASSETS 25,721,593 49,155,422
Long-Term Marketable Securities 12,462,367 --
Property and Equipment, Net 6,428,511 4,819,820
Patents and Trademarks, Net 944,816 1,079,785
Other Assets 116,460 128,869
------------ ------------
TOTAL ASSETS $ 45,673,747 $ 55,183,896
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Accounts Payable 1,731,398 2,970,237
Accrued Payroll, Vacation and Related Costs 756,191 607,700
Other Accrued Expenses 1,330,250 642,287
Deferred Income 731,250 --
------------ ------------
TOTAL CURRENT LIABILITIES 4,549,089 4,220,224
Long-Term Debt 1,500,000 1,500,000
------------ ------------
TOTAL LIABILITIES 6,049,089 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 January 31, 1997 and July 31, 1996 8,750 8,750
Common Stock, $.01 par value. Authorized
35,000,000 shares; issued and outstanding
28,754,457 shares at January 31, 1997,
and 28,641,707 shares at July 31, 1996 287,545 286,417
Additional Paid-In Capital 92,024,916 91,536,256
Cumulative Translation Adjustment (7,541) --
Accumulated Deficit (52,689,012) (42,367,751)
------------ ------------
TOTAL SHAREHOLDERS' EQUITY 39,624,658 49,463,672
------------ ------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 45,673,747 $ 55,183,896
============ ============
See accompanying notes to consolidated financial statements.
</TABLE>
<TABLE>
<CAPTION>
ANGEION CORPORATION
Consolidated Statements of Operations
Three and Six Months Ended January 31, 1997 and 1996
(Unaudited)
Three Months Ended Six Months Ended
January 31, January 31,
1997 1996 1997 1996
------------ ------------ ------------ ------------
<S> <C> <C> <C> <C>
Net Sales $ 766,406 $ 267,029 $ 2,489,451 $ 422,359
Operating Expenses:
Manufacturing 1,758,117 599,926 3,375,815 1,224,798
Research & Development 4,019,066 1,941,290 7,582,190 4,107,946
Selling, General & Administrative 1,754,795 848,363 2,787,416 1,512,183
------------ ------------ ------------ ------------
Total Operating Expenses 7,531,978 3,389,579 13,745,421 6,844,927
------------ ------------ ------------ ------------
OPERATING LOSS (6,765,572) (3,122,550) (11,255,970) (6,422,568)
------------ ------------ ------------ ------------
Other Income (Expense):
Interest Income 444,490 278,199 993,241 598,975
Interest Expense (29,478) (29,283) (58,532) (58,606)
------------ ------------ ------------ ------------
Other Income 415,012 248,916 934,709 540,369
------------ ------------ ------------ ------------
NET LOSS $ (6,350,560) $ (2,873,634) $(10,321,261) $ (5,882,199)
============ ============ ============ ============
NET LOSS PER SHARE $ (.22) $ (.13) $ (.36) $ (.28)
============ ============ ============ ============
Weighted Average Number of Shares
Outstanding 28,715,609 21,375,280 28,683,529 21,279,421
============ ============ ============ ============
See accompanying notes to consolidated financial statements.
</TABLE>
<TABLE>
<CAPTION>
ANGEION CORPORATION
Consolidated Statements of Cash Flows
Six Months Ended January 31, 1997 and 1996
(Unaudited)
1997 1996
------------ ------------
<S> <C> <C>
OPERATING ACTIVITIES:
Net Loss $(10,321,261) $ (5,882,199)
Adjustments to Reconcile Net Loss
to Net Cash Used in Operating Activities:
Depreciation and Amortization 827,658 393,680
Compensation Expense on Grant of Stock and Stock Options 262,238 349,223
Changes in Operating Assets and Liabilities:
Accounts Receivable 1,111,740 (180,140)
Inventories (4,144,279) (1,294,489)
Prepaid Expenses and Other Current Assets (446,380) 8,246
Accounts Payable (1,238,839) 890,372
Accrued Expenses 1,567,704 101,128
------------ ------------
Net Cash Used in Operating Activities (12,381,419) (5,614,179)
------------ ------------
INVESTING ACTIVITIES:
Purchase of Short-Term Investments 11,400,000 --
Proceeds from Maturities of Short-Term Investments (31,342,583) (11,398,188)
Payments for Purchases of Property and Equipment (2,288,971) (1,191,649)
Increase in Other Assets -- (231,733)
------------ ------------
Net Cash Used in Investing Activities (22,231,554) (12,821,570)
------------ ------------
FINANCING ACTIVITIES:
Proceeds from Issuance of Common Stock and Warrants, Net -- 20,327,045
Proceeds from Exercise of Stock Options and Warrants 227,550 2,107,506
Repayments of Capital Lease Obligation and Note Payable -- (1,764)
------------ ------------
Net Cash Provided by Financing Activities 227,550 22,432,787
------------ ------------
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS (7,541) --
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (34,392,964) 3,997,038
Cash and Cash Equivalents:
Beginning of Period 35,183,919 2,367,764
------------ ------------
End of Period $ 790,955 $ 6,364,802
============ ============
Supplemental Disclosure of Cash Flow Information:
Cash Paid During the Period for Interest $ 5,160 $ 4,906
============ ============
See accompanying notes to financial statements.
</TABLE>
ANGEION CORPORATION
Form 10-Q
January 31, 1997
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 material adjustments, consisting only of normally recurring
adjustments, necessary for a fair presentation of the financial position,
results of operations and cash flows for the interim periods presented.
2. FOREIGN CURRENCY TRANSLATION
The functional currency and denomination of all sales transactions of Angeion
Europe Ltd. are the U.S. dollar. Accordingly, the financial statements of
Angeion Europe Ltd., which are maintained in the local currency, are remeasured
into U.S. dollars in accordance with Statement of Financial Accounting Standards
No. 52, FOREIGN CURRENCY TRANSLATION. All exchange gains or losses from
remeasurement of monetary assets and liabilities that are not denominated in
U.S. dollars are recognized currently in income.
The financial statements of Angeion GmbH, whose functional currency is the
German Mark, are translated at current rates of exchange for net accounts and at
average exchange rates for the period for items of Income and Expense. The
resulting translation adjustments are recorded directly into a separate
component of shareholders equity.
3. 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.
4. PUBLIC OFFERINGS
In July 1996, the Company completed a public offering of 4.2 million shares of
newly issued Common Stock for net proceeds of $27,401,887. In March 1996, an
additional $11,630,337 in net proceeds were 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 securities for research and development, 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 (abnormal 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 ("ICD's") and expand its European business activities. For the
same reasons, a German subsidiary, Angeion GmbH, was 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 JANUARY 31, 1997, COMPARED TO THE THREE MONTHS ENDED JANUARY
31, 1996
Net sales increased 187 percent to $766,406 in the three months ended January
31, 1997 from $267,029 in the same period of fiscal 1996. This increase was due
to increased sales in Europe as well as increased U.S. clinical activity and was
partially offset by cessation of OEM sales to Pacesetter, Inc., a subsidiary of
St. Jude Medical. In October 1996, St. Jude Medical, the Company's distribution
partner, announced its intention to acquire Ventritex, Inc., a company that
manufactures and markets defibrillator products similar to the Company's
products. Although the full impact of the acquisition, which is currently
pending, is not known at this time, the Company anticipates that the
acquisition, if consummated, will eventually result in the dissolution of the
OEM distribution relationship with St. Jude. See "Legal Proceedings" below. The
Company has accelerated the development of its own sales force and is in the
process of evaluating and 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 193 percent to $1,758,117 in the three months
ended January 31, 1997 from $599,926 in the same period of fiscal 1996. Included
in manufacturing expense is the standard cost of products sold and the start-up
costs associated with the establishment of the manufacturing operation, which
include unfavorable manufacturing variances and excess capacity.
Research and development expense increased 107 percent to $4,019,066 in the
three months ended January 31, 1997 from $1,941,290 in the same period of fiscal
1996. The Company continues to focus its research and development activities on
its series of ICDs, which represent $3,544,620 of the recorded expense, and its
catheter ablation development activities, which represent $474,446 of expense.
The Company anticipates that research and development expense will continue to
increase, reflecting the Company's intent to simultaneously move current
products through development and human clinical studies as rapidly as possible;
introduce enhancements to current products; and accelerate the development of a
fifth generation ICD.
Selling, general and administrative expense increased 107 percent to $1,754,795
in the three months ended January 31, 1997 from $848,363 in the same period of
fiscal 1996. This increase relates primarily to the addition of the two
wholly-owned subsidiaries in Germany and in the U.K. as well as payroll expense
related to the addition of staff in the United States. Selling expense is
expected to continue to increase as the Company accelerates development of a
U.S. direct sales force during the next six months.
Interest income increased 60 percent to $444,490 in the three months ended
January 31, 1997 from $278,199 in the same period in fiscal 1996. This increase
was due to an increase in the average balance of cash, cash equivalents and
marketable securities in the quarter ended January 31, 1997 compared to the same
period in fiscal 1996.
SIX MONTHS ENDED JANUARY 31, 1997, COMPARED TO THE SIX MONTHS ENDED JANUARY 31,
1996
Net sales increased 489 percent to $2,489,451 in the six months ended January
31, 1997 from $422,359 in the same period in fiscal 1996. This increase was due
to increased sales in Europe as well as increased U.S. clinical activity. This
increase was also due to increased OEM sales to Pacesetter, Inc. in the three
months ended October 31, 1996, although these OEM sales were cessation in the
three months ended January 31, 1997, following St. Jude Medical's announced
intention to acquire Ventritex, Inc. as described above.
Manufacturing expense increased 176 percent to $3,375,815 in the six months
ended January 31, 1997 from $1,224,798 in the same period in fiscal 1996.
Included in manufacturing expense is standard cost of products sold and expense
associated with the manufacturing start-up and expansion of manufacturing
capacity.
Research and development expense increased 85 percent to $7,582,190 in the six
months ended January 31, 1997 from $4,107,946 in the same period in fiscal 1996.
That increase resulted from increased expense in U.S. clinical studies as well
as ongoing development of ICD and catheter ablation technologies.
Selling, general and administrative expense increased 84 percent to $2,787,416
in the six months ended January 31, 1997 from $1,512,183 in the same period in
fiscal 1996. The increase in selling expense was a result of international
expansion and development of the U.S. marketing organization. General and
administrative expenditures increased primarily due to higher legal costs and
expenses to support a growing employee base.
Interest income increased 66 percent to $993,241 in the six months ended January
31, 1997 from $598,975 in the same period in fiscal 1996, due to higher average
invested cash, cash equivalents and marketable securities balances.
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 during 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 $12,381,419 and $5,614,179 in the
six-month periods ended January 31, 1997 and 1996, respectively. The cash used
during these periods was primarily related to the research and development
activities of the Company's ICD and catheter ablation divisions (including
clinical studies) and, during the six-month period ended January 31, 1997, was
also related to the build-up of inventory and increased sales and marketing
expenses.
The Company's expenditures for fixed assets were $2,288,971 for the six-month
period ended January 31, 1997 and $1,191,649 for the same period in 1996. 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
development capabilities, fixed asset expenditures are expected to continue to
increase.
At January 31, 1997, the Company had cash and cash equivalents of $790,955 and
marketable securities of $27,310,873. In July 1996, the Company completed a
public offering of Common Stock that resulted in net proceeds of $27,401,887. In
March 1996, an additional $11,630,337 in net proceeds were received from the
exercise of warrants. In August 1995, the Company completed a public offering of
Common Stock that resulted in net proceeds of $20,327,045.
Assuming the Company's operations progress as anticipated (of which there can be
no assurance), the Company believes that its existing balances of cash, cash
equivalents and marketable securities, along with cash generated from
operations, should provide sufficient capital for approximately the next 12 to
14 months. To the extent that the Company's operations do not progress as
anticipated, however, additional capital may be needed sooner. The timing of the
Company's capital needs and the amount of capital needed will depend 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; the
impact of the acquisition by St. Jude Medical of Ventritex, Inc.; the ability of
the Company to build its own clinical and distribution networks; and the
Company's ability to secure alternative OEM distribution channels. The Company
has activities underway to obtain its required capital, however there can be no
assurance 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 a 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; 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 any 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 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. OTHER INFORMATION
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"). 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. The parties are currently in the process of
attempting to resolve this dispute and effect a dissolution of their
distribution relationship.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS.
The Annual Meeting of the Shareholders of the Company was held on December 11,
1996. The following matters were voted on and approved by the Company's
shareholders at the Annual Meeting. The tabulation of votes with respect to each
of the following matters voted on at the Annual Meeting is set forth as follows:
<TABLE>
<CAPTION>
For Against Abstain Broker Non-Vote
------- ------- ------- ---------------
1. ELECTION OF DIRECTORS
<S> <C> <C> <C> <C>
Whitney A. McFarlin 26,043,319 180,164
Arnold A. Angeloni 26,041,194 182,289
Dennis E. Evans 26,031,271 192,212
Lyle D. Joyce, M.D., Ph.D 26,045,894 177,589
Joseph C. Kiser, M.D 26,035,944 187,539
Donald D. Maurer 26,041,644 181,839
Dennis L. Sellke 26,040,544 182,939
Glen Taylor 26,037,194 186,289
2. AMEND THE COMPANY'S ARTICLES OF INCORPORATION TO INCREASE THE NUMBER OF
AUTHORIZED SHARES OF COMMON STOCK FROM 35,000,000 TO 50,000,000.
23,789,706 1,622,338 110,706 700,733
3. AMEND THE COMPANY'S 1993 STOCK INCENTIVE PLAN TO INCREASE THE NUMBER OF
SHARES RESERVED FOR ISSUANCE BY 1,500,000.
10,581,007 2,771,280 265,503 12,335,693
4. AMEND THE 1994 NON-EMPLOYEE DIRECTOR PLAN TO INCREASE THE NUMBER OF SHARES
RESERVED FOR ISSUANCE BY 100,000.
11,867,824 2,066,163 273,680 12,015,816
5. RATIFICATION OF KPMG PEAT MARWICK LLP AS AUDITORS FOR THE YEAR ENDING JULY
31, 1997.
26,010,565 113,690 99,228 0
</TABLE>
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
(a) Exhibit 27.1 Financial Data Schedule.
(b) No reports were filed on Form 8-K during the quarter for
which this report was filed.
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: March 14, 1997 By /s/ David L. Christofferson
David L. Christofferson
Chief Financial Officer
Vice President of Finance
(principal financial and accounting officer)
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> JUL-31-1996
<PERIOD-END> JAN-31-1997
<CASH> 790,955
<SECURITIES> 27,310,873
<RECEIVABLES> 1,383,011
<ALLOWANCES> 0
<INVENTORY> 8,093,629
<CURRENT-ASSETS> 25,721,593
<PP&E> 8,968,649
<DEPRECIATION> 2,540,138
<TOTAL-ASSETS> 45,673,747
<CURRENT-LIABILITIES> 4,549,089
<BONDS> 0
0
8,750
<COMMON> 287,545
<OTHER-SE> 39,328,363
<TOTAL-LIABILITY-AND-EQUITY> 45,673,747
<SALES> 2,489,451
<TOTAL-REVENUES> 2,489,451
<CGS> 3,375,815
<TOTAL-COSTS> 3,375,815
<OTHER-EXPENSES> 10,369,606
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 58,532
<INCOME-PRETAX> (10,321,261)
<INCOME-TAX> 0
<INCOME-CONTINUING> (10,321,261)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (10,321,261)
<EPS-PRIMARY> (.36)
<EPS-DILUTED> 0
</TABLE>
