U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(X) Quarterly report under Section 13 of 15(d) of the Securities Exchange
Act of 1934.
For the quarterly period ended NOVEMBER 30, 1996, or
( ) Transition report under Section 13 or 15(d) of the Securities Exchange
Act of 1934 for the transition period from ____________ to ___________.
Commission file number 0-19866
CELOX LABORATORIES, INC.
(Exact name of small business issuer
as specified in its charter)
MINNESOTA 36-3384240
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
5959 BAKER ROAD, SUITE 320, MINNETONKA, MN 55345
(Address of principal executive offices) (Zip Code)
Issuers telephone number, including area code: (612) 933-2616
Check whether the issuer (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Act of 1934 during the past 12 months (or
for such shorter periods that the issuer was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days.
Yes __X__ No ____
State the number of shares outstanding of each the issuer's classes of common
equity, as of the latest practicable date.
THE NUMBER OF SHARES OF COMMON STOCK, PAR VALUE $.01 PER SHARE, OUTSTANDING ON
NOVEMBER 30, 1996 WAS 2,742,169.
Transitional small business format disclosure:
Yes ____ No __X__
Table of Contents
CELOX LABORATORIES, INC.
Report on Form 10-QSB
for fiscal quarter ended
November 30, 1996
PART I -- FINANCIAL INFORMATION Page
ITEM 1. Financial Statements
Balance Sheet as of August 31, 1996
and November 30, 1996 3
Statement of Operations -- Three month ended
November 30, 1995 and 1996 5
Statement of Changes in Shareholders' Equity
for the year ended August 31, 1996 and the
three months ended November 30, 1996 6
Statement of Cash Flows -- Three months ended
November 30, 1995 and 1996 7
Notes to Financial Statements 8
ITEM 2. Management's Discussion and Analysis of Financial
Conditions and Results of Operations 10
PART II -- OTHER INFORMATION 14
PART I -- FINANCIAL INFORMATION
ITEM 1 -- FINANCIAL STATEMENTS
CELOX LABORATORIES, INC.
BALANCE SHEET
November 30, August 31,
ASSETS 1996 1996
----------- -----------
CURRENT ASSETS
Cash and cash equivalents $ 899,716 $ 420,222
Certificates of Deposit 490,005 968,663
Trade receivables 101,674 91,802
Investor settlement receivable -- current 0 57,328
Accrued interest receivable 7,510 19,002
Inventories 61,233 74,372
Prepaid expenses 7,348 814
----------- -----------
Total current assets 1,567,486 1,632,203
----------- -----------
INVESTOR SETTLEMENT RECEIVABLE 22,446 22,446
EQUIPMENT AND LEASEHOLD IMPROVEMENTS
Laboratory and production equipment 204,882 204,882
Office furniture and equipment 78,764 78,764
Leasehold improvements 64,390 64,390
----------- -----------
348,036 348,036
Less accumulated depreciation (264,422) (254,432)
----------- -----------
83,614 93,604
----------- -----------
TOTAL ASSETS $ 1,673,546 $ 1,748,253
=========== ===========
CELOX LABORATORIES, INC.
BALANCE SHEET
November 30, August 31,
LIABILITIES AND SHAREHOLDERS' EQUITY 1996 1996
----------- -----------
CURRENT LIABILITIES
Accounts payable $ 20,689 $ 29,748
Accrued liabilities 33,074 33,452
----------- -----------
Total current liabilities 53,763 63,200
----------- -----------
DEFERRED RENT 0 773
SHAREHOLDERS' EQUITY
Common Stock 27,422 27,422
Additional contributed capital 5,251,756 5,251,756
----------- -----------
5,279,178 5,279,178
Accumulated deficit (3,659,395) (3,594,898)
----------- -----------
Total Shareholders' Equity 1,619,783 1,684,280
----------- -----------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 1,673,546 $ 1,748,253
=========== ===========
See Notes to Financial Statements.
CELOX LABORATORIES, INC.
STATEMENT OF OPERATIONS
- --------------------------------------- ----------- -----------
Three months ended November 30, 1996 1995
- --------------------------------------- ----------- -----------
REVENUES
Net sales $ 85,705 $ 114,358
Cost of products sold 39,667 55,523
- --------------------------------------- ----------- -----------
GROSS MARGIN 46,038 58,835
- --------------------------------------- ----------- -----------
OPERATING EXPENSES
Research and development 19,794 38,288
Marketing and sales 30,340 72,001
Administration 81,016 71,753
- --------------------------------------- ----------- -----------
Total operating expenses 131,150 182,042
OPERATING LOSS (85,112) (123,207)
OTHER INCOME
Interest and investment income 19,574 41,023
Other income 1,041 0
Investment gain 0 15,400
- --------------------------------------- ----------- -----------
Total other income 20,615 56,423
NET LOSS ($ 64,497) ($ 66,784)
======================================= =========== ===========
LOSS PER COMMON SHARE ($ 0.02) ($ 0.02)
======================================= =========== ===========
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 2,742,169 2,742,169
======================================= =========== ===========
See Notes to Financial Statements.
<TABLE>
<CAPTION>
CELOX LABORATORIES, INC.
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
- -----------------------------------------------------------------------------------------------------------------------------------
Additional Unrealized
Common Stock Paid-in Accumulated Gain on Inv.
Shares Amount Capital Deficit Avail. for Sale Total
- ----------------------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C> <C>
BALANCE AT AUGUST 31, 1994 2,764,669 $27,647 $5,268,681 ($2,864,260) 0 $2,432,068
Common stock repurchased (22,500) (225) (16,925) (17,150)
Unrealized gains for the period 38,798 38,798
Net loss for the period (346,614) (346,614)
- -----------------------------------------------------------------------------------------------------------------------------------
BALANCE AT AUGUST 31, 1995 2,742,169 $27,422 $5,251,756 ($3,210,874) $38,798 $2,107,102
Net changes in unrealized gains for
the year (38,798) (38,798)
Net loss for the period (384,024) (384,024)
- -----------------------------------------------------------------------------------------------------------------------------------
BALANCE AT AUGUST 31, 1996 2,742,169 $27,422 $5,251,756 ($3,594,898) $0 $1,684,280
Net loss for the period (64,497) (64,497)
- -----------------------------------------------------------------------------------------------------------------------------------
BALANCE AT NOVEMBER 30, 1996 2,742,169 $27,422 $5,251,756 ($3,659,395) $0 $1,619,783
See Notes to Financial Statements.
</TABLE>
<TABLE>
<CAPTION>
CELOX LABORATORIES, INC.
STATEMENT OF CASH FLOWS
- -------------------------------------------------------------- ---------- ----------
Three months ended November 30, 1996 1995
- -------------------------------------------------------------- ---------- ----------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss for the period ($ 64,497) ($ 66,784)
Adjustments to reconcile net loss to
net cash used in operating activities:
Depreciation and amortization 9,989 11,786
Deferred rent expense (773) (1,157)
Changes in assets and liabilities:
(Increase) decrease in:
Accounts receivable (9,872) (37,923)
Accrued interest receivable 11,491 (12,827)
Inventories 13,139 (3,791)
Prepaid expenses (6,534) 131
Increase (decrease) in:
Accounts payable (9,059) 12,681
Accrued liabilities (377) 16,147
- -------------------------------------------------------------- --------- ---------
Net cash used in operating activities (56,492) (81,737)
- -------------------------------------------------------------- --------- ---------
CASH FLOWS FROM INVESTING ACTIVITIES:
Maturity (Purchase) of bank certificates of deposit 478,658 (767,784)
Proceeds from sale of short-term investments held for sale 0 230,100
Proceeds from investor settlement receivables 57,328 0
Purchase of equipment 0 (8,449)
- -------------------------------------------------------------- --------- ---------
Net cash from (used for) investing activities 535,986 (546,133)
- -------------------------------------------------------------- --------- ---------
Net increase (decrease) in cash
and cash equivalents 479,494 (627,870)
CASH AND CASH EQUIVALENTS:
Beginning of period 420,222 919,404
- -------------------------------------------------------------- --------- ---------
End of period $ 899,716 $ 291,534
============================================================== ========= =========
See Notes to Financial Statements.
</TABLE>
CELOX LABORATORIES, INC,
NOTES TO FINANCIAL STATEMENTS -- NOVEMBER 30, 1996
NOTE A -- BASIS OF PRESENTATION
The accompanying financial statements have been prepared in accordance with
generally accepted accounting principles for interim financial information and
with the instructions to Form 10-QSB and Item 310 of Regulation S-B.
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 adjustments (consisting only of normal
recurring adjustments) considered necessary for a fair presentation have been
included.
The organization and business of the Company, accounting policies followed
by the Company and other information are contained in the notes to the Company's
financial statements filed as part of the Company's August 31, 1996 Form 10-KSB.
This quarterly report should be read in connection with such annual report.
NOTE B -- CASH AND CASH EQUIVALENTS
For purposes of reporting the statements of cash flows, the Company
considers all highly liquid debt instruments purchased with a maturity of three
months or less to be cash equivalents.
NOTE C -- SHORT-TERM INVESTMENTS
The Company had invested excess cash in the Piper Jaffray Institutional
Government Income Portfolio Fund (Piper Fund). During the quarter ended February
29, 1996, the Company sold all remaining shares in this Fund.
As an alternative to the Piper Fund, the Company has utilized Bank
Certificates of Deposit. As of November 30, 1996 the Company had investments of
$490,005 in Certificates of Deposit. Certificates of deposit are made only with
the highest rated banks and less than $100,000 is deposited at any one bank. The
Company also utilizes a money market fund, which is restricted by its charter to
Tier 1 instruments, for a portion of its investments.
NOTE D -- REPURCHASE OF COMMON STOCK
Effective July 30, 1993, the Board of Directors authorized the repurchase
of up to 300,000 shares of the Company's common stock in open market
transactions at prices not to exceed $1.75 per share. At November 30, 1996 the
Company had repurchased 136,700 shares at prices ranging from $0.85 to $1.58 per
share.
NOTE E -- LOSS PER COMMON SHARE
Loss per share is computed based upon the weighted average number of common
shares outstanding during the period. The Company has determined that under the
modified treasury stock method, there would be no change in earnings per share
due to outstanding common stock equivalents. Fully diluted and primary loss per
share are the same amounts for each of the periods presented.
NOTE F -- RECLASSIFICATION
Certain 1996 amounts have been reclassified to conform with the 1997
presentation. These reclassifications had no effect on net income (loss) as
previously reported.
ITEM 2 -- MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
INTRODUCTION
Celox Laboratories, Inc. ("Celox" or the "Company") is a biotechnology
company formed in 1985 that researches, develops, manufactures and markets cell
biology products used in the propagation of cells derived from mammals,
including humans, and other species. These specialized cell growth products are
used primarily in academic, pharmaceutical, diagnostic and other commercial
laboratories to improve the growth condition, productivity and quality of
cell-derived medical and other biological products such as vaccines, monoclonal
antibodies, interferons and human growth factor. The Company focuses primarily
on solving the fundamental problems associated in culturing cells with the use
of serum, which is derived from the whole blood of animals and humans. The
Company's research activities have resulted in proprietary technology which has
been used to commercialize its non-serum growth media, cell freezing solutions
and other cell biology products.
Celox currently manufactures and markets over 30 products. Celox's
proprietary products consist of four serum replacement products, TCM,
TM-235(TM), TCH(TM), and VaxMax(TM) and a cell freezing medium, Cellvation(TM).
VaxMax(TM) was developed specifically for use in the production of veterinary
vaccines.
Celox also manufactures ten basal media formulations, a series of buffered
salt solutions, other cell biology reagents and a variety of custom
formulations.
An additional proposed product, ViaStem(TM), continues to undergo further
analysis in pre-clinical testing. This product was developed to improve the
preservation of critical cells (e.g. stem cells) which are required for bone
marrow transplantation. Other potential applications for ViaStem(TM) include the
preservation of umbilical cord blood and platelets. Currently, Memorial Blood
Centers of Minnesota and the University of Cincinnati's Hoxworth Blood Center
will be providing additional pre-clinical data on ViaStem(TM).
During the quarter ended November 30, 1996, the Company received notice
from the United States Patent and Trademark Office (USPTO) that a patent for
ViaStem(TM) would be issued in early December, 1996. The actual patent was
received by the Company in the first week of December. The Company has also
filed the documents needed for an International Patent Application as required
by the Patent Cooperation Treaty.
During February, 1996 the Company entered into an agreement with the
Department of the Army, Walter Reed Army Institute of Research (WRAIR) that
provides for a Cooperative Research and Development Agreement for Material
Transfer which encompasses the Company's ViaStem(TM) product.
The Company has received its first Drug Master File classification from the
Food and Drug Administration (FDA) for TCM. This classification will expedite
the FDA approval process for customers who want to use the Company's TCM product
in the manufacture of drugs or drug substances for human use. The Company is in
the process of gaining similar status for its other proprietary products.
In April, 1994 the Company entered into an agreement with American Type
Culture Collection (ATCC), Rockville, MD, the world's largest public archive of
living biological cultures and genetic materials. ATCC serves the international
scientific community by acquiring, preserving and distributing strains of the
most diverse collection of organisms and derivative biological materials in the
world. Under the agreement, ATCC will distribute cell lines adapted to the
Company's non-serum products as well as other associated products worldwide.
Orders for growth media under this agreement have continued during the current
fiscal year.
During July of 1995, the Company completed a non-exclusive world-wide
distribution agreement with ICN Pharmaceuticals, Inc., Costa Mesa, CA. Under the
agreement, ICN is marketing Celox's TCM, TCH(TM), TM-235(TM) serum replacement
products as well as Cellvation(TM). Initial orders under this agreement were
shipped in the last quarter of Fiscal 1995. Additional orders have been received
during the first three months of this fiscal year.
ICN manufactures and markets a broad range of prescription and
over-the-counter pharmaceuticals, medical diagnostic products and biotechnology
research products in North and Latin America, Eastern and Western Europe and the
Pacific Rim countries.
Beginning in fiscal 1997, the Company is providing its proprietary products
to Sigma Chemical Company under a private label distribution agreement. The
first shipment under this agreement occurred during the quarter ended November
30, 1996.
RESULTS OF OPERATIONS
The Company had recorded an Investor Settlement Receivable in the amount of
$133,000 on the Balance Sheet in order to reflect the expected settlement
proceeds from a class action lawsuit which was brought on behalf of investors in
the Piper Fund. In December, 1995, the District Court Judge approved the Class
action Settlement. Payments from the Piper Fund have been received in accordance
with the schedule agreed upon in the settlement. As of November 30, 1996 the
Investor Settlement Receivable is $22,446.
A separate Class Action lawsuit against the Fund's auditors, KPMG Peat
Marwick, has been certified by the Court.
During the quarter ended November 30, 1996, the Company had net sales of
$85,705 which was an decrease of $28,653 or 25% from $114,358 reported in the
same quarter for the prior year. The decrease between years results from the
timing of orders received from a large manufacturer as well as the timing of
orders from distributors relative to the previous year.
The Company had a net loss of $64,497 for the quarter ended November 30,
1996 compared to a net loss of $66,784 for the same period in the previous year.
On a per share basis, the loss for the current quarter equalled 2 cents which is
the same as the 2 cent loss in the previous year.
The cost of products sold was 46% of net sales for the three months ended
November 30, 1996, as compared to 49% of net sales for the three months ended
November 30, 1995. The improvement between years is a combination of a greater
level of sales of proprietary products, which have higher margins than standard
formulations, and manufacturing labor, raw materials and other production costs
have been consistently controlled.
An operating loss of $85,112 was generated for the quarter ended November
30, 1996 compared to an operating loss of $123,207 for the same period in the
previous year. The significant improvement between years is due in general to a
decrease in research and development expenditures, lower marketing and sales
expenses offset by higher administrative expenditures. The decrease in research
and development expenses reflects the timing of expenses incurred in connection
with the Company's ViaStemTM product.
Future research and development expenses could be higher as clinical testing
begins.
The Company received interest and investment income of $19,574 during the
quarter ended November 30, 1996 as compared to $41,023 in the prior year.
Investment income is derived primarily from the investment of the proceeds of
the Company's March 1992 initial public offering. The decrease in investment
income during the quarter as compared to the previous year results from reduced
investment balances as the Company uses capital in its operations as well as
lower effective interest rates resulting from a transfer of amounts from the
Piper Fund into bank certificates of deposit. Additionally, in the quarter ended
November 30, 1995, the Company received special one-time dividends paid out from
the Piper Fund.
For the quarter ended November 30, 1996 the Company had no investment gains
compared to an investment gain of $15,400 during the comparable period a year
ago. In the prior year, a gain was realized when shares of the Piper Jaffray
fund were sold.
As was disclosed in previous sections of this Form 10-QSB, Piper Jaffray
and the Class Action Plaintiffs have agreed to settle a lawsuit which was
brought against the Piper Fund by investors. A lawsuit filed against the Fund's
auditors, KPMG Peat Marwick, is still being pursued by investors other than the
Company. The Company has not filed a lawsuit nor has it decided if it will join
in any future class actions, but has not eliminated these options as a
possibility in the future.
Operating expenses decreased $50,892 (28%) to $131,150 from $182,042 for
the quarters ended November 30, 1996 and November 30, 1995 respectively. The
decrease as compared to the prior year is due to the timing and amount of
research and development expenditures as well as reduced marketing and sales
expenses offset by higher administrative expenditures.
Research and development costs decreased by $18,494 to $19,794 from $38,288
in the current quarter as compared to the previous fiscal year. The decrease
results from the timing of expenditures in the areas of salaries and wages and
patent expenses incurred in connection with the ViaStemTM product. The Company
expects the costs of research and development to fluctuate based on the status
of pre-clinical and clinical trials for ViaStemTM.
Marketing expenses decreased by $41,661 (58%) to $30,340 from $72,001 for
the quarter ended November 30, 1996 compared to the quarter ended November 30,
1995. The decreases are attributable to the amount and timing of advertising,
promotional materials and trade show expenses between years. The Company expects
that marketing and sales expenses will increase during subsequent quarters as
programs and advertising materials are developed.
Administrative expenses increased by $9,263 (13%) for the quarter ended
November 30, 1996 compared to the previous fiscal year to $81,016 from $71,753.
The increase between years is primarily due to moving expenses incurred as part
of the Company's move to a new facility.
LIQUIDITY AND CAPITAL RESOURCES
Capital resources on hand at November 30, 1996 include cash and short-term
investments of $1,389,721 and net working capital of $1,513,723. This represents
an increase of $836 (less than 1%) in cash and short-term investments and a
decrease of $55,280 (3.5%) in net working capital as compared to August 31,
1996.
The lease for the Company's facilities terminated in October, 1996. A new
facility is currently being constructed in Oakdale, Minnesota, a suburb of St.
Paul. The Company will lease approximately 9,500 square feet of office
laboratory and warehouse space in this facility. The Company expects to move
into the Oakdale facility during February, 1997. In the interim, the Company has
leased office and warehouse space on a month-to-month basis.
The Company anticipates spending approximately $175,000 in fiscal 1997 on
capital expenditures. Through November 30, 1996 the Company has not made any
capital expenditures. The majority of the planned expenditures will be used to
fund additional sales, research and development, manufacturing growth and
specialized tenant improvements. It is anticipated that the tenant improvements
will be financed through a local financial institution.
The Company believes that its capital resources on hand at November 30,
1996, together with revenues from product sales, will be sufficient to meet its
cash requirements for the near future.
PART II -- OTHER INFORMATION
ITEM I -- LEGAL PROCEDINGS
The Company is a member of the class in the KPMG Peat Marwick action as it
relates to their audit of the Piper Jaffray Institutional Government Income
Portfolio Fund, on whose behalf litigation has been commenced in federal
district court in Minneapolis. the Company has not directly participated in the
litigation and the Company does not believe any material developments in the
status of the litigation occurred during the quarter which is the subject of
this report.
The Company is a defendant in a wrongful termination lawsuit brought by a
former employee who was in the probationary period at the time of the
termination. The Company believes that the lawsuit is without merit. However, it
has participated in an arbitration hearing in order to bring closure to this
lawsuit. As of December 31, 1996, a final settlement document still has not been
executed.
ITEM 2 -- CHANGES IN SECURITIES
None
ITEM 3 -- DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4 -- SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5 -- OTHER INFORMATION
None
ITEM 6 -- (A) EXHIBITS
Exhibit 27 - Financial Data Schedule
(B) REPORTS ON FORM 8-K
On September 26, 1996, the Company filed a Form 8-K that reported that the
NASDAQ Stock Market delisted Celox Laboratories, Inc. for failing to meet an
exchange requirement of maintaining net tangible assets of at least $2,000,000.
SIGNATURES
In accordance with the requirements of the Exchange Act, the Registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
CELOX LABORATORIES, INC.
Dated: January 13, 1997 By: /S/ Milo R. Polovina
-----------------------------------
Milo R. Polovina, President &
Principal Financial Officer
<TABLE> <S> <C>
<ARTICLE> 5
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<NAME> CELOX LABORATORIES, INC.
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> AUG-31-1997
<PERIOD-END> NOV-30-1996
<CASH> 899,716
<SECURITIES> 490,005
<RECEIVABLES> 101,674
<ALLOWANCES> 0
<INVENTORY> 61,233
<CURRENT-ASSETS> 1,567,486
<PP&E> 348,036
<DEPRECIATION> 264,422
<TOTAL-ASSETS> 1,673,546
<CURRENT-LIABILITIES> 53,763
<BONDS> 0
0
0
<COMMON> 27,422
<OTHER-SE> 1,592,361
<TOTAL-LIABILITY-AND-EQUITY> 1,673,546
<SALES> 85,705
<TOTAL-REVENUES> 85,705
<CGS> 39,667
<TOTAL-COSTS> 120,683
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<LOSS-PROVISION> 0
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<INCOME-PRETAX> (64,497)
<INCOME-TAX> 0
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