<PAGE> 1
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(MARK ONE)
XX Quarterly Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934.
For the period ended March 31, 1998.
___ 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: 0-16128
TUTOGEN MEDICAL, INC.
(FORMERLY BIODYNAMICS INTERNATIONAL, INC.)
(Exact name of registrant as specified in its charter)
FLORIDA 59-3100165
(State or other Jurisdiction of (I.R.S. Employer
Incorporation or Organization) Identification No.)
1719 ROUTE 10, SUITE 314, PARSIPPANY, NEW JERSEY 07054
(Address of Principal Executive Offices) (Zip Code)
REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE: (973) 359-8444
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK, PAR VALUE $.01
(Title of Class) (Name of Each Exchange on Which Registered)
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 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_.
As of May 4, 1998 there were outstanding 5,313,822 shares of Biodynamics
International, Inc. Common Stock, par value $0.01.
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TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
INDEX
<TABLE>
<CAPTION>
Page
<S> <C> <C> <C>
PART I. Financial Information.
ITEM 1. Financial Statements.
Consolidated Balance Sheets - March 31, 1998 and 1
December 31, 1997.
Consolidated Statements of Operations for the 2
three and six months ended March 31, 1998 and
1997.
Consolidated Statements of Cash Flows for the 3
three and six months ended March 31, 1998 and
1997.
Notes to Consolidated Financial Statements. 4
ITEM 2. Management's Discussion and Analysis of Financial 7
Condition and Results of Operations.
PART II. Other Information.
ITEM 4. Submission of Matters to a Vote of 9
Security-Holders.
ITEM 6. Exhibits and Reports on Form 8-K 9
SIGNATURES 10
</TABLE>
<PAGE> 3
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS.
TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
<TABLE>
<CAPTION>
(unaudited) (audited)
March 31 September 30
1998 1997
------- -------
<S> <C> <C>
ASSETS
Current Assets
Cash and cash equivalents $ 756 $ 777
Accounts receivable 1,711 1,738
Inventories 3,202 2,391
Other current assets 190 94
------- -------
5,859 5,000
Property, plant and equipment, net 2,796 2,996
Intangible and other assets, net 762 1,106
------- -------
TOTAL ASSETS $ 9,417 $ 9,102
======= =======
LIABILITIES AND SHAREHOLDERS' EQUITY (Deficiency)
Current Liabilities
Accounts payable $ 1,247 $ 980
Accrued interest 72 267
Other accrued expenses 1,003 1,115
Note payable and debt, current portion 862 6,820
------- -------
3,184 9,182
Other Liabilities
Long-term debt 3,643 1,175
Other long-term obligations 10 10
Shareholders' Equity (Deficiency) 2,580 (1,265)
------- -------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 9,417 $ 9,102
======= =======
</TABLE>
See accompanying Notes to Consolidated Financial Statements.
1
<PAGE> 4
<TABLE>
<CAPTION>
TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands except per share data)
THREE MONTHS ENDED MARCH 31, SIX MONTHS ENDED MARCH 31,
1998 1997 1998 1997
----------- ----------- ----------- -----------
<S> <C> <C> <C> <C>
OPERATING REVENUES
Revenue $ 2,047 $ 2,138 $ 3,997 $ 4,624
Cost of revenue 1,105 1,291 2,272 2,729
----------- ----------- ----------- -----------
Gross margin 942 847 1,725 1,895
OPERATING EXPENSES
General and administrative 474 512 863 1,056
Distribution and marketing 371 540 665 1,112
Research and development 58 110 124 137
Depreciation and amortization 173 332 356 695
----------- ----------- ----------- -----------
1,076 1,494 2,008 3,000
OPERATING LOSS (134) (647) (283) (1,105)
License fee (200) -- (200) --
Other income (44) 258 (67) 250
Interest expense 83 162 180 352
----------- ----------- ----------- -----------
(161) 420 (87) 602
NET INCOME (LOSS) BEFORE INCOME TAXES 27 (1,067) (196) (1,707)
Income taxes 3 -- 12 --
----------- ----------- ----------- -----------
NET INCOME (LOSS) $ 24 $ (1,067) $ (208) $ (1,707)
=========== =========== =========== ===========
Average common shares outstanding 5,313,832 8,551,000 4,867,482 8,451,000
=========== =========== =========== ===========
Net income (loss) per share $ 0.01 $ (0.12) $ (0.04) $ (0.20)
=========== =========== =========== ===========
See accompanying Notes to Consolidated Financial Statements
2
</TABLE>
<PAGE> 5
TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF CASH FLOWS
(IN THOUSANDS)
<TABLE>
<CAPTION>
SIX MONTHS ENDED MARCH 31,
1998 1997
------- -------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (208) $(1,707)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 637 883
Increase (decrease) in cash resulting from changes in:
Accounts receivable 27 (36)
Inventories (811) (892)
Prepaid expenses and other current assets (96) (129)
Accounts payable and accrued liabilities (40) 1,129
------- -------
Net cash used in operating activities (491) (752)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of property, plant and equipment (93) (43)
Increases in intangible and other assets -- 26
------- -------
Net cash provided by (used in) investing activities (93) (17)
CASH FLOWS FROM FINANCING ACTIVITIES
Issuance of stock 4,185 22
Proceeds from long-term borrowings 500 782
Repayment of short-term borrowings (3,886) (205)
Repayment of long-term debt (119) (248)
------- -------
Net cash provided by financing activities 680 351
EFFECT OF EXCHANGE RATE CHANGES ON CASH (117) (78)
NET DECREASE IN CASH AND CASH EQUIVALENTS (21) (496)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 777 531
------- -------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 756 $ 35
======= =======
SUPPLEMENTAL CASH FLOW DISCLOSURES
Interest paid $ 180 $ 342
======= =======
</TABLE>
See accompanying Notes to Consolidated Financial Statements
3
<PAGE> 6
TUTOGEN MEDICAL, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1998
(IN THOUSANDS, EXCEPT SHARE DATA)
(1) OPERATIONS AND ORGANIZATION
Tutogen Medical, Inc. (formerly Biodynamics International, Inc.) with its
consolidated subsidiaries ("the Company") processes, manufactures and
distributes worldwide specialty surgical products and tissue processing
services for neuro, orthopedic, cardiovascular, reconstructive and general
surgical applications. The Company's core business is processing human
donor tissue ("allografts") utilizing its patented Tutoplast(R) process for
distribution to hospitals and surgeons. At the Annual Meeting of
shareholders of the Company held on March 30, 1998, the Company's
shareholders approved the proposal to change the name of the Company from
"Biodynamics International, Inc." to "Tutogen Medical, Inc."
During the year ended September 30, 1997, the ban on the use of human dura
mater in two of the Company's important markets had a material adverse
effect on the Company's results of operations and financial position. As a
result, the Company initiated a significant restructuring of their
capitalization for both short-term and long-term capital requirements. The
recapitalization consisted of five major segments, which were ratified by
the Company's lenders and shareholders in 1997. The recapitalization
enabled the Company to obtain additional working capital financing while
reducing the Company's debt/interest burden and preferred stock
capitalization. As a result, holders of selected debt and Series C
preferred stock converted their holdings to the Company's common stock.
While additional working capital financing in the way of bridge loans and
the Series C preferred stock conversion were completed in 1997, the
remainder of the recapitalization program was completed in the quarter
ended December 31, 1997. This included the replacement of the bridge loans
with a convertible debenture loan on November 11, 1997 (see Note 4) and the
conversion in December 1997 of certain loans by the mezzanine lenders to
the Company's German subsidiary to common stock (see Note 4). Additionally,
a one-for-ten reverse stock split on November 11, 1997 was implemented to
accommodate the various recapitalization transactions (see Note 3).
(2) SIGNIFICANT ACCOUNTING POLICIES
In the opinion of management, the accompanying unaudited consolidated
financial statements of the Company and the unaudited results of
operations and cash flows for the three months ended March 31, 1998 and
1997 have been prepared in conformity with generally accepted accounting
principles applied on a consistent basis and include all adjustments
necessary in order to make the financial statements not misleading. The
interim financial statements should be read in conjunction with the
audited consolidated financial statements of the Company for the year
ended September 30, 1997. Significant accounting policies of the Company
are presented below.
FOREIGN CURRENCY TRANSLATION. The functional currency of the Company's
German subsidiary is the Deutsche Mark. This subsidiary also represents the
Company's largest operating segment and, accordingly, the translation of
financial statements is affected by significant changes in the exchange
rate. The translation of the subsidiary's operations reflect a
strengthening of the U.S. dollar against the Deutsche Mark to an average
exchange rate of DM 1.79 and DM 1.59 for the six months ended March 31,
1998 and 1997, respectively.
4
<PAGE> 7
PRINCIPLES OF CONSOLIDATION. The consolidated financial statements include
the accounts of the Company and its wholly-owned subsidiaries.
RECLASSIFICATIONS. Certain prior period financial statement balances have
been reclassified to conform with the current period presentation.
(3) SHAREHOLDERS' EQUITY (DEFICIENCY)
Shareholders' equity (deficiency) at March 31, 1998 and September 30, 1997
consisted of the following:
<TABLE>
<CAPTION>
(unaudited) (audited)
March 31, September 30,
1998 1997
-------- --------
<S> <C> <C>
Shareholders' Equity (deficiency):
Common Stock, par value $.01 per share, with
5,313,832 and 26,875,090 issued and outstanding
at March 31, 1998 and September 30, 1997,
respectively $ 53 $ 84
Paid in capital 27,126 22,910
Cumulative Foreign Currency Translation Adjustment (391) (259)
Accumulated deficit (24,208) (24,000)
-------- --------
$ 2,580 $ (1,265)
======== ========
</TABLE>
On November 10, 1997, the Board of Directors approved a 1-for-10 reverse stock
split (the "Reverse Split"). The Reverse Split reduced the number of common
shares outstanding at October 10, 1997 (herein "effective date") from
approximately 26,875,000 shares to 2,687,500 shares. As of the effective date,
there were outstanding options to purchase an aggregate 2,492,000 shares of
common stock. The Reverse Split agreement provides for an automatic adjustment
of the number of shares and the price per share of common stock shares that may
be purchased under the 1996 Stock Option Plan and 1992 Stock Option Plan (herein
the"Plans"). The Company subsequently canceled all of the outstanding stock
options previously issued under its stock option plans (the "Old Options"), (to
current employees and directors) and replaced them with new options (the "New
Options"), to remedy the negative effect of the Reverse Split on the exercise
prices of Old Options which had ranged from $0.4375 per share to $1.10 per share
before the Reverse Split, and $4.375 per share to $11.00 per share after the
Reverse Split. Generally, New Options were issued for a new number of shares of
Common Stock which new number of shares is 40% of the former number of shares
into which the Old Options were exercisable before the Reverse Split. The
exercise price of the New Options is equivalent to the market price of the
Common Stock on the date of the grant of the New Options, $1.57.
On December 24, 1997, all of the mezzanine debt and related accrued interest
(approximately $4.1 million), that was carried by the Company's German
subsidiary, was exchanged for 2,626,301 shares of the Company's Common Stock.
5
<PAGE> 8
(4) LONG-TERM DEBT
Long-term debt at March 31, 1998 and September 30, 1997 consisted of the
following:
<TABLE>
<CAPTION>
(unaudited) (audited)
March 31, September 30,
1998 1997
------ ------
<S> <C> <C>
Revolving credit facilities interest ranging
from 7.75% to 8.5% $ 773 $ 719
Bridge loans, 12% interest due; December 31, 1997 -- 2,036
Senior debt, 7.75% interest until March 30, 1998
when terms are renegotiable
1,127 1,215
Mezzanine debt, LIBOR plus 4%, interest
(7.3125% at September 30, 1997); due 1999 -- 3,978
Capital lease obligations, 8.5% interest due; 2000 31 47
Convertible debenture, 9% interest due; 2002 2,574 --
------ ------
4,505 7,995
Less current portion 1,362 6,820
------ ------
$3,143 $1,175
====== ======
</TABLE>
On December 24, 1997, all of the Mezzanine debt and related accrued interest
(approximately $4.1 million) was exchanged for 2,626,301 of the Company's common
stock.
On November 11, 1997, one of the institutional investors agreed to exchange the
bridge loans for a five-year convertible debenture convertible into 4,413,231
shares of common stock and warrants exercisable at $2,015,991 for 806,396 shares
of common stock.
On March 23, 1998, the Company received $500,000 from one of its institutional
investors and issued a 9% convertible debenture, due in November 2002.
(5) DISTRIBUTION AGREEMENT
On January 14, 1998, the Company entered into an agreement with Mentor
Corporation "Mentor" for the purpose of granting a license to Mentor to
exclusively distribute selected products which the Company processes utilizing
the Tutoplast(R) process. This license grants Mentor the right to distribute
these selected products on an exclusive basis in their field of use which is
defined as all urological and gynecological applications and procedures in the
United States and all foreign markets. AFTER SUCCESSFUL COMPLETION AND APPROVAL
OF AN APPROPRIATE CLINICAL TRIALS PROTOCOL, THE COMPANY WAS PAID A FEE BY MENTOR
OF $200. The term of the agreement is for seven years with options to extend on
the same terms and conditions for an additional five (5) year period.
6
<PAGE> 9
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
AND RESULTS OF OPERATIONS
(Amounts in thousands)
RESULTS OF OPERATIONS
Comparisons between the 1998 and 1997 periods should recognize the approximate
12% increase in the U.S. dollar against the German Deutsche Mark. The effect of
such increase will result in lower revenues, expenses and net loss.
NET INCOME (LOSS)
Net income for the three months ended March 31, 1998 totaled $24 or $0.01 per
share as compared to a net loss of $1,067 or $0.12 per share for the same period
a year ago. Net loss for the six months ended March 31, 1998 was $208 or $0.04
per share as compared to a net loss of $1,707 or $0.02 per share. The decrease
in the net loss is directly attributed to reductions made in depreciation,
selling, general and administrative expenses as a result of the 1997 downsizing
in operations. This downsizing was necessitated by the ban on the use of human
dura mater tissue in the Japanese market during the quarter ending June 30,
1997. In addition, the Company completed the restructuring of its capitalization
during the quarter ending December 31, 1997. As such, interest expense for the
period was reduced by $79 or 49% from the comparable period a year ago. This
quarter also reflects an up-front license and distribution fee of $200, received
for the exclusive rights to market the Company's Tutoplast(R) facia lata in
urological indications.
REVENUE AND COST OF REVENUE
Revenue for the three months ended March 31, 1998 decreased 4% to $2,047 from
$2,138 for the comparable period. The revenue for the six months ended March 31,
1998 decreased 14% to $3,997 from $4,624 for the comparable period. The decrease
is largely attributed to the ban on the use of human dura mater tissue in the
Japanese market and the discontinuation of the Company's unprofitable sutures
business. However, it should be noted that, exclusive of the Japanese market,
the revenue for the first half of the year represents a 24% increase over the
comparable period last year.
Gross margins for the three months ended March 31, 1998 increased to 46% from
40% for the comparable period last year. The gross margins for the six months
ended March 31, 1998 increased to 43% from 41% for the comparable period last
year. The increase is primarily attributable to price increases and a favorable
mix resulting from the discontinuation of the unprofitable suture business.
GENERAL AND ADMINISTRATIVE
General and administrative expenses decreased 7% and 18% for the three and six
month periods ending March 31, 1998, respectively, from the comparable periods
last year. The decreases are due primarily to a reduction in headcount and legal
and consulting expenses.
DISTRIBUTION AND MARKETING
Distribution and marketing expenses decreased 31% and 40% for the three and six
month periods ending March 31, 1998, respectively, from the comparable periods
last year. The decrease is primarily associated with the cost saving measures
instituted as a result of the discontinuation of revenue from the Japanese
market.
7
<PAGE> 10
RESEARCH AND DEVELOPMENT
Research and development expenses decreased 47% and 9% for the three and six
month periods ending March 31, 1998, respectively, from the comparable periods
last year. The decrease from prior periods is due to a reduction in the use of
outside research consultants.
DEPRECIATION AND AMORTIZATION
Depreciation and amortization decreased 48% for the three and six month periods
ending March 31, 1998 from the comparable periods last year. The reduction in
depreciation and amortization is attributed to substantial write downs of
intangible and fixed assets taken, primarily due to the discontinued
international suture business, during the quarter ending September 30, 1997.
OTHER INCOME AND LICENSE FEE
The Company received an up-front license fee during the second quarter, in the
amount of $200, for the rights to market its Tutoplast(R) facia lata in
urological indications. Other income increased 117% and 127% for the three and
six month periods ending March 31, 1998, respectively, from the comparable
periods last year, reflecting an exchange gain on the conversion of the
mezzanine debt.
INTEREST EXPENSE
Interest expense declined 49% for the three and six month periods ending March
31, 1998 from the comparable periods last year. The reduction is directly
attributed to the capital restructuring which was completed during the quarter
ending December 31, 1997. The restructuring included the conversion of long-term
debt to common stock.
LIQUIDITY AND CAPITAL RESOURCES
At March 31, 1998 and September 30, 1997 the Company had working capital of
$2,675 and negative working capital of $4,182 respectively. The Company
maintains current working capital lines totaling DM 1,850 (approximately $1,000)
with several German banks. At March 31, 1998 the Company had borrowed $773
against these lines.
The significant improvement in the working capital position from September 30,
1997 to March 31, 1998 was due to the recapitalization of the Company that was
completed during the three months ending December 31, 1997. In the past the
Company has relied upon its available working capital lines and institutional
investors to fund operational cash flow, when needed. The Company is actively
negotiating with its institutional investors for loans/investments to bridge its
working capital needs. As a result, the Company received an additional loan, in
the amount of $500 this quarter. In addition, the Company is continuing to seek
other investors to infuse additional capital into the Company. While management
believes that it will be successful in securing new funding, there can be no
assurances that it will be able to do so. Lack of new funding along with the
inability to increase processing revenues could result in a curtailment of
operations in the future.
The Company's ability to generate positive operational cash flow is dependent
upon increasing processing revenue through increased recoveries by tissue banks
in the U.S. and Europe, and the development of additional markets and surgical
applications worldwide. While the Company believes that it continues to make
progress in both these areas, there can be no assurances that changing
governmental regulations will not have a material adverse effect on results of
operations and cash flow.
8
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PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY-HOLDERS
An annual Meeting of Stockholders was held on March 30,
1998. All management's nominees for director, as listed in
the Proxy Statement for the Annual Meeting, were elected.
Listed below are the matters voted on by stockholders and
the number of votes cast at the Annual Meeting:
(a) Election of five members of the Board of Directors.
<TABLE>
<CAPTION>
Broker
Voted Votes Non-Votes
Name Voted For Against Withheld and Abstentions
---- --------- ------- -------- ---------------
<S> <C> <C> <C> <C>
G. Russell Cleveland 4,590,493 0 8,310 0
Charles C. Dragone 4,590,493 0 8,310 0
J. Harold Helderman 4,590,493 0 8,310 0
Karl H. Meister 4,590,493 0 8,310 0
Elroy G. Roelke 4,588,143 0 10,660 0
</TABLE>
(b) Approval of the amendment to the Company's Articles of
Incorporation to change the name of the Company from
"Biodynamics International, Inc." to "Tutogen Medical, Inc."
Voted For: 4,552,181
Voted Against: 42,212
Voted Abstained: 4,410
Broker Non-Votes 0
(c) Ratification of the appointment of Deloitte and Touche L.L.P.
as independent auditors of the Company for the fiscal year
ending September 30, 1998.
Voted For: 4,592,833
Voted Against: 2,455
Voted Abstained: 3,515
Broker Non-Votes 0
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K.
EXHIBITS
No. 27 Financial Data Schedule
No reports on Form 8-K were filed by the Company during the
quarter ended March 31, 1998.
9
<PAGE> 12
SIGNATURES
Registrant has duly caused this report to be signed on its behalf by the
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
undersigned, thereunto duly authorized.
TUTOGEN MEDICAL, INC.
Date: May 5, 1998 /s/ Karl H. Meister
-------------------
President and Chief Executive Officer
Date: May 5, 1998 /s/ George Lombardi
-------------------
Chief Financial Officer
(Principal Financial and Accounting Officer)
10
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONDENSED FINANCIAL STATEMENTS FOR THE QUARTER ENDED MARCH 31, 1998 AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> SEP-30-1998
<PERIOD-END> MAR-31-1998
<CASH> 755,685
<SECURITIES> 0
<RECEIVABLES> 1,882,173
<ALLOWANCES> 171,566
<INVENTORY> 3,201,608
<CURRENT-ASSETS> 5,858,602
<PP&E> 4,240,039
<DEPRECIATION> (1,443,989)
<TOTAL-ASSETS> 9,416,930
<CURRENT-LIABILITIES> 3,183,033
<BONDS> 0
0
0
<COMMON> 53,570
<OTHER-SE> 2,526,461
<TOTAL-LIABILITY-AND-EQUITY> 9,416,930
<SALES> 2,047,344
<TOTAL-REVENUES> 2,047,344
<CGS> 1,104,642
<TOTAL-COSTS> 1,104,642
<OTHER-EXPENSES> 832,694
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 82,741
<INCOME-PRETAX> 27,267
<INCOME-TAX> 3,264
<INCOME-CONTINUING> 24,003
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 24,003
<EPS-PRIMARY> 0.01
<EPS-DILUTED> 0.01
</TABLE>
