<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
(Mark One)
[x] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the quarterly period ended March 31, 1998
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT
For the transition period to
--------- ----------
Commission file number 0-20988
---------------------------
ANTEX BIOLOGICS INC.
- -------------------------------------------------------------------------------
(Exact name of small business issuer as specified in its charter)
<TABLE>
<S> <C>
Delaware 52-1563899
- ------------------------------------------------ ---------------------------------------------------
(State or other jurisdiction of incorporation (IRS Employer Identification No.)
or organization)
</TABLE>
300 Professional Drive, Gaithersburg, MD 20879
- -------------------------------------------------------------------------------
(Address of principal executive offices)
(301) 590-0129
- -------------------------------------------------------------------------------
(Issuer's telephone number)
- -------------------------------------------------------------------------------
(Former name, former address and former fiscal year,
if changed since last report)
Check whether the issuer (1) filed all reports required to be filed by Section
13 or 15(d) of the Exchange Act during the past 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 [ ]
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS DURING THE PRECEDING FIVE YEARS
Check whether the registrant filed all documents and reports required to be
filed by Section 12, 13 or 15(d) of the Exchange Act after the distribution of
securities under a plan confirmed by a court. Yes [ ] No [ ]
APPLICABLE ONLY TO CORPORATE USERS
State the number of shares outstanding of each of the issuer's classes of
common equity, as of the latest practicable date.
22,480,304 shares of Antex Biologics Inc. common stock, $.01 par value, were
outstanding as of April 30, 1998.
Transitional Small Business Disclosure Format (check one):
Yes No X
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<PAGE> 2
ANTEX BIOLOGICS INC.
FORM 10-QSB
QUARTER ENDED MARCH 31, 1998
INDEX
<TABLE>
<CAPTION>
Part I. Financial Information Page No.
--------
<S> <C> <C>
Item 1. Financial Statements
Consolidated Balance Sheets at December 31, 1997 and
March 31, 1998 (Unaudited) 3
Consolidated Statements of Operations (Unaudited) for the
three months ended March 31, 1997 and 1998 and the period
August 3, 1991 (inception) to March 31, 1998 4
Consolidated Statements of Cash Flows (Unaudited) for the
three months ended March 31, 1997 and 1998 and
the period August 3, 1991 (inception) to March 31, 1998 5-6
Notes to Consolidated Financial Statements 7-9
Item 2. Management's Discussion and Analysis of Financial Condition 9-12
and Results of Operations
Part II. Other Information
Item 6. Exhibits and Reports on Form 8-K 12
Signatures 13
Exhibit
</TABLE>
2
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Antex Biologics Inc.
(a development stage enterprise)
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
DECEMBER 31, MARCH 31,
1997 1998
---- ----
ASSETS (UNAUDITED)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 5,697,156 $ 5,439,216
Accounts and other receivables 712,906 528,855
Prepaid expenses and deposits 272,917 160,409
---------- ---------
Total current assets 6,682,979 6,128,480
Property and equipment, net 446,861 508,586
Deferred compensation trust 229,405 229,405
--------- ---------
$ 7,359,245 $ 6,866,471
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses $ 531,345 $ 400,685
Deferred research and development revenue 554,152 474,141
-------- -------
Total current liabilities 1,085,497 874,826
Deferred gain on equipment 106,983 99,342
Deferred compensation 229,405 229,405
Excess of fair value over cost of net assets acquired, net of
accumulated amortization of $181,180 and $188,239 101,173 94,114
Other 19,647 13,254
Commitments and contingencies
Stockholders' equity:
Preferred stock, $.01 par value; 5,000,000 shares
authorized; none outstanding - -
Common stock, $.01 par value; 95,000,000 shares
authorized; 22,480,304 shares issued and
outstanding 224,803 224,803
Additional paid-in capital 17,752,839 17,752,839
Deficit accumulated during the development stage (12,161,102) (12,422,112)
---------- ----------
Total stockholders' equity 5,816,540 5,555,530
---------- ---------
$ 7,359,245 $ 6,866,471
=========== ===========
</TABLE>
The accompanying notes are an integral part of these financial statements.
3
<PAGE> 4
Antex Biologics Inc.
(a development stage enterprise)
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS AUGUST 3, 1991
ENDED MARCH 31 (INCEPTION)
-------------- TO
1997 1998 MARCH 31, 1998
---- ---- --------------
<S> <C> <C> <C>
Revenues $ 1,296,848 $ 1,079,495 $ 10,534,393
----------- ----------- ------------
Expenses:
Research and development 975,613 1,043,918 14,302,669
General and administrative 583,700 364,626 8,962,684
---------- --------- ---------
Total expenses 1,559,313 1,408,544 23,265,353
---------- --------- ----------
Loss from operations (262,465) (329,049) (12,730,960)
Other income (expense):
Interest income 86,331 68,039 1,017,205
Interest expense (10,123) - (708,357)
------------ --------- -----------
Net loss $ (186,257) $ (261,010) $(12,422,112)
============ ============ ============
Net loss per share, basic and
diluted $(.01) $(.01)
====== ======
Weighted average shares
outstanding, basic and diluted 22,188,016 22,188,641
========== ==========
</TABLE>
The accompanying notes are an integral part of these financial statements.
4
<PAGE> 5
Antex Biologics Inc.
(a development stage enterprise)
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS AUGUST 3, 1991
ENDED MARCH 31 (INCEPTION)
---------------------- TO
1997 1998 MARCH 31, 1998
---- ---- ---------------
<S> <C> <C> <C>
OPERATING ACTIVITIES
Net loss $ (186,257) $ (261,010) $(12,422,112)
Adjustments to reconcile net
loss to net cash used in
operating activities:
Depreciation and amortization of
property and equipment, net of
amortization of deferred gain on
sale/leaseback and equipment 23,615 23,035 219,900
Amortization of deferred credits (13,452) (13,452) (355,412)
Expense recorded on issuance of
common stock and vesting of options - - 531,134
Changes in operating assets
and liabilities:
Accounts and other receivables (455,607) 184,051 (528,855)
Prepaid expenses and deposits (48,076) 112,508 (44,167)
Accounts payable and accrued
expenses 108,072 (130,660) (31,895)
Deferred research and development 43,316 (80,011) 443,575
Due from affiliate - - 420,448
----------- ----------- -----------
Net cash used in operating activities (528,389) (165,539) (11,767,384)
--------- --------- ------------
INVESTING ACTIVITIES
Purchase of property and equipment (2,477) (92,401) (598,579)
Decrease in restricted cash 300,000 - -
--------- ----------- ----------
Net cash provided by (used in) investing
activities 297,523 (92,401) (598,579)
-------- --------- ---------
</TABLE>
The accompanying notes are an integral part of these financial statements.
(Continued)
5
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Antex Biologics Inc.
(a development stage enterprise)
CONSOLIDATED STATEMENTS OF CASH FLOWS (CONTINUED)
(UNAUDITED)
<TABLE>
<CAPTION>
THREE MONTHS AUGUST 3, 1991
ENDED MARCH 31 (INCEPTION)
---------------------- TO
1997 1998 MARCH 31, 1998
---- ---- ----------------
<S> <C> <C> <C>
FINANCING ACTIVITIES
Net proceeds from sales of common stock
and warrants and the exchange option
$ - $ - $11,606,170
Net proceeds from exercise of
warrants and stock options - - 4,862,148
Proceeds from sale and leaseback
agreement - - 2,164,792
Principal repayments on sale and
leaseback agreement (451,412) - (2,164,792)
Proceeds from issuance of notes payable - - 500,000
Proceeds from sale of preferred stock - - 400,189
-------------- -------------- ---------
Net cash provided by (used in)
financing activities (451,412) - 17,368,507
--------------- -------------- ----------
Net increase (decrease) in cash and
cash equivalents (682,278) (257,940) 5,002,544
Cash and cash equivalents at
beginning of period 6,918,836 5,697,156 436,672
-------------- -------------- ----------
Cash and cash equivalents at
end of period $ 6,236,558 $ 5,439,216 $ 5,439,216
============== ============== ===========
SUPPLEMENTAL CASH FLOWS DISCLOSURES:
Notes payable and accrued interest
converted to preferred stock $ - $ - $ 509,109
============== ============== ===========
Sale and leaseback of property and
equipment $ - $ - $ 2,099,175
============== ============== ===========
Capitalized equipment $ - $ - $ 152,832
============== ============== ===========
Deferred compensation $ - $ - $ 229,405
============== ============== ===========
Interest paid $ 10,123 $ - $ 699,248
============== ============== ===========
</TABLE>
The accompanying notes are an integral part of these financial statements.
6
<PAGE> 7
Antex Biologics Inc.
(a development stage enterprise)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE THREE-MONTH PERIODS ENDED MARCH 31, 1997 AND 1998
(UNAUDITED)
1. GENERAL
Antex Biologics Inc. (the "Company") is a biopharmaceutical company
committed to improving health by developing new products to prevent and treat
infectious diseases and related disorders. With respect to its human bacterial
vaccine research and development, the Company currently has a strategic
alliance with SmithKline Beecham and technology license agreements with Pasteur
Merieux Connaught and the United States Navy.
The Consolidated Balance Sheet as of March 31, 1998, and the Consolidated
Statements of Operations for the three-month periods ended March 31, 1997 and
1998 and for the period August 3, 1991 (inception) to March 31, 1998, and the
Consolidated Statements of Cash Flows for the three-month periods ended March
31, 1997 and 1998 and for the period August 3, 1991 (inception) to March 31,
1998 have been prepared without audit. However, such financial statements
reflect all adjustments (consisting solely of normal recurring adjustments)
that are, in the opinion of management, necessary for a fair presentation of
the consolidated financial position of Antex Biologics Inc. and its subsidiary
at March 31, 1998, and the consolidated results of their operations and their
cash flows for the periods referred to above.
Certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted accounting
principles have been condensed or omitted. These financial statements should
be read in conjunction with the financial statements and notes thereto for the
fiscal year ended December 31, 1997 included in the Company's Annual Report on
Form 10-KSB.
Certain reclassifications were made to the 1997 financial statements to
conform to the 1998 presentation.
The results of operations for the period ended March 31, 1998 are not
necessarily indicative of the operating results anticipated for the fiscal year
ending December 31, 1998.
Since inception, the Company's revenues have been generated solely in
support of its research and development activities and as of March 31, 1998,
the Company's research and products are not sufficiently developed to enable
the Company to generate sufficient revenues on an ongoing basis. As a result,
the Company is considered to be in the development stage.
7
<PAGE> 8
2. STRATEGIC ALLIANCE
Effective March 1996, the Company executed definitive agreements with
SmithKline Beecham Corporation and SmithKline Beecham Biologicals
Manufacturing s.a. ("SmithKline") which established a corporate joint venture,
MicroCarb Human Vaccines Inc.("MCHV"), to develop and commercialize human
bacterial vaccines utilizing the Company's proprietary technologies. The
agreements provide for the following: a payment of $3,000,000 to the Company
in connection with SmithKline's acquisition of a 26.25% equity interest in
MCHV; payments totalling $2,400,000 and $2,600,000 to the Company to fund
research and development for the first and second years, respectively, with
SmithKline having the option to fund future years; an option granted to
SmithKline, expiring October 1, 1998, to acquire from the Company an additional
equity interest in MCHV; an exchange option granted by the Company to
SmithKline enabling SmithKline to convert its equity interest in MCHV for up to
4,793,685 shares of the Company's common stock, under specified conditions; and
a warrant granted by the Company to SmithKline currently enabling SmithKline to
acquire up to 5,761,978 shares of the Company's common stock, under specified
conditions, and only to the extent that stipulated options and warrants
previously granted and outstanding as of the date of the establishment of the
strategic alliance are exercised. The agreements also provide for SmithKline
to make milestone payments and pay royalties to MCHV; and for SmithKline to
reimburse the Company for expenses the Company incurs for agreed upon
production of vaccine material for clinical trials, the conduct of agreed upon
clinical trials, and the agreed upon prosecution and maintenance of the
Company's patents and patent applications. As further stipulated in the
agreements, SmithKline will be responsible for conducting additional clinical
trials, manufacturing, and sales and distribution.
Revenue related to the human bacterial vaccine research and development
provided in connection with the strategic alliance has been recognized to the
extent of actual expenses incurred. Amounts received but unearned have been
deferred. Additional expenses that qualify as reimbursables due from
SmithKline pursuant to the provisions of the agreements, have been recognized
as revenue.
For the three months ended March 31, 1998, the Company recognized revenue
related to human bacterial vaccine research and development and qualifying
reimbursable expenses of $970,527. For the three months ended March 31, 1997,
revenue of $1,213,362 was recognized.
3. EARNINGS PER SHARE
In 1997, the Company adopted Statement of Financial Accounting Standards
No. 128 ("SFAS 128"), Earnings per Share. Basic earnings per share is computed
by dividing net income (loss) available to common shareholders by the weighted
average number of common shares outstanding during the period. Diluted
earnings per share is computed by dividing net income (loss) available to
common shareholders by the weighted average number of common shares outstanding
after giving effect to all dilutive potential common shares that were
outstanding during the period. The Company did not have any dilutive
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<PAGE> 9
potential common shares during the periods ended March 31, 1997 and 1998.
Earnings per share for the period ended March 31, 1997 did not require
restatement to conform to SFAS 128.
4. REVERSE STOCK SPLIT
On March 26, 1998, the Board of Directors approved resolutions to amend
the Certificate of Incorporation to effect a reverse stock split, subject to
shareholder approval. If effected, the reverse stock split would be in the
range of one-for-four to one-for-ten. The following table presents the
pro-forma effect of the reverse stock split on loss per share for the
quarters ended March 31, 1997 and 1998:
<TABLE>
<CAPTION>
Prior to After
Reverse Stock Split Reverse Stock Split
------------------- -------------------
1 for 10 1 for 4
-------- -------
<S> <C> <C>
Net loss for the quarter ended
March 31, 1997 $186,257 $186,257
Net loss per share for the quarter ended
March 31, 1997 $.01 $.08 $.03
Net loss for the quarter ended
March 31, 1998 $261,010 $261,010
Net loss per share for the quarter ended
March 31, 1998 $.01 $.12 $.05
</TABLE>
5. COMPREHENSIVE INCOME
Effective January 1, 1998, the Company adopted Statement of Financial
Accounting Standards No. 130, "Reporting Comprehensive Income" ("SFAS 130").
SFAS 130 requires additional reporting requirements with respect to certain
changes in assets and liabilities that previously were not to be reported as
results of operations for the period. For the three month periods ended March
31, 1997 and 1998, the Company did not have any components of comprehensive
income.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The Company commenced operations in August 1991.
Effective March 1996, the Company executed definitive agreements with
SmithKline which established MCHV to develop and commercialize human bacterial
vaccines utilizing the Company's proprietary technologies (see Note 2 to the
unaudited financial statements).
The strategic alliance with SmithKline is consistent with one aspect of
the Company's overall strategy which, since its inception, has been to
establish strategic partnerships and
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<PAGE> 10
to focus on researching technologies with the goal of developing new products
to prevent and treat infectious diseases and related disorders. The Company is
operating as a development stage enterprise.
RESULTS OF OPERATIONS
Revenues for the first quarter of 1998 include the recognition of human
bacterial vaccine research and development support of $780,010 and reimbursable
expenses incurred of $190,517 pursuant to the strategic alliance with
SmithKline. The Company also earned $108,968 from a Small Business Innovation
Research ("SBIR") grant. Revenue for the comparable period in 1997 consisted
of $606,684 of human bacterial vaccine research and development support and
reimbursable expenses incurred of $606,678 in connection with the strategic
alliance, and $83,486 from SBIR grants.
Research and development expenses in the first quarter of 1998 increased
to $1,043,918 in comparison to $975,613 in the first quarter of 1997. After
giving effect to the nonrecurrence of clinical trial expenses incurred in the
first quarter of 1997 of $165,000, research and development expenses in the
first quarter of 1998 increased 28.8% over the comparable period in 1997. The
increase is attributable to increased efforts and expenditures for additional
personnel resulting directly from the increase in activities related to the
strategic alliance with SmithKline and to the field of therapeutics.
General and administrative expenses in the first quarter of 1998
decreased 37.5% to $364,626 in comparison to $583,700 in the comparable period
in 1997. The decrease is attributable primarily to the nonrecurrence of the
fees incurred in the first quarter of 1997 in connection with overseas patent
application filings, such fees having been reimbursed to the Company pursuant
to the provisions of the strategic alliance with SmithKline.
The decrease in interest income in the first quarter of 1998 of $18,292
reflects the decrease in cash available for investing.
LIQUIDITY AND CAPITAL RESOURCES
In connection with the Company's strategic alliance with SmithKline, the
Company received $2,600,000 of annual funding for research and development of
human bacterial vaccines in 1997. In addition, the Company is reimbursed by
SmithKline for expenses that it incurs in connection with the agreed upon
production of vaccine material for clinical trials, the conduct of agreed upon
clinical trials, and the agreed upon prosecution and maintenance of the
Company's patents and patent applications.
During 1998, MCHV will continue to assess to which human bacterial
vaccine research projects resources will be allocated. The Company anticipates
that its research and development expenses related to human bacterial vaccines
will continue to be substantial for the foreseeable future and anticipates that
sufficient funding will be provided through the strategic alliance with
SmithKline. The Company is utilizing a portion of its available resources to
pursue other research and development activities in the field of therapeutics.
10
<PAGE> 11
To fund these research and development activities and general and
administrative expenses, the Company will be required to rely on its current
assets and future financings.
For 1998, the Company currently anticipates that it will increase its
total employees and contract personnel by approximately three from a 1997 year
end total of 30.
As a development stage company, the Company's operating activities have
been limited primarily to research and development involving its proprietary
technologies, and accordingly, have generated limited revenues. The Company is
scheduled to receive approximately $3,200,000 in 1998 in research and
development payments from SmithKline covering the period March 1, 1998 to
February 28, 1999, of which $700,000 was received in March 1998. Additionally,
the costs incurred by the Company associated with the conduct of an ongoing
Phase I clinical trial for Helicobacter pylori and agreed upon clinical trials
for Campylobacter jejuni, the agreed upon production of vaccine material, and
the prosecution of the Company's patents and patent applications are
reimbursable by SmithKline. SmithKline's second option to increase its
ownership in MCHV, at a cost of $1,000,000, expires on October 1, 1998.
Research currently being performed by the Company under a Phase II SBIR grant
from The National Institutes of Health pertaining to the Company's vaccine for
Chlamydia trachomatis, which expires in 1998, is anticipated to generate
approximately $160,000 in payments. The Company is also scheduled to receive a
milestone payment from Pasteur Merieux Connaught of $500,000 in December 1998.
With respect to the Company's negotiations to extend its facility lease
and expand its existing space, financing for the expansion and any related
renovations would be provided by the landlord. It is anticipated that any
funds required in excess of the amount provided by the landlord will be
obtained through equipment financing and/or by utilizing the current assets of
the Company.
In order to fully fund its operations over the longer term, the Company
will continue to seek additional financing. The Company has no lines of
credit. In seeking additional funding, the Company continues to examine a
range of possible transactions, including: additional strategic alliances; the
exercise of the unit purchase option issued to the Placement Agent in
connection with the 1995 private placement; possible increases in research and
development funding by SmithKline; and the exercise by SmithKline of its
warrant to the extent that it becomes exercisable. Additional public offerings
and private placements, and the filing of additional applications for SBIR
grants are also possible sources of funds. However, there is no assurance that
additional funds will be available from these or any other sources or, if
available, that the terms on which such funds can be obtained will be
acceptable to the Company.
NEW ACCOUNTING STANDARD
The Financial Accounting Standards Board has issued a new standard which
became effective for years beginning after December 15, 1997. Statement of
Financial Accounting Standards No. 131 ("SFAS 131"), Disclosures about Segments
of an Enterprise and Related Information, requires financial and descriptive
information with respect to "operating
11
<PAGE> 12
segments" of an entity based on the way management disaggregates the entity for
making internal operating decisions. The Company will begin making the
disclosures required by SFAS 131 with financial statements for the year ending
December 31, 1998.
YEAR 2000 DISCLOSURE
The Company has analyzed its computer systems and related applications to
assess the expected impact of the Year 2000 date recognition issue on these
systems and applications. Management does not anticipate that the costs
associated with the Year 2000 issue will have a material adverse affect on the
financial condition or results of operations of the Company.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF
1995
Statements contained herein that are not historical facts may be
forward-looking statements that are subject to a variety of risks and
uncertainties. There are a number of important factors that could cause actual
results to differ materially from those expressed in any forward-looking
statements made by the Company. These factors include, but are not limited to:
(i) Company's ability to successfully complete product research and
development, including preclinical and clinical studies and commercialization;
(ii) the Company's ability to obtain required governmental approvals; (iii) the
Company's ability to attract and/or maintain manufacturing, sales, distribution
and marketing partners; and (iv) the Company's ability to develop and
commercialize its products before its competitors.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
EXHIBITS
<TABLE>
<CAPTION>
Exhibit
No. Description
------- -----------
<S> <C>
27.1 Financial Data Schedule
</TABLE>
REPORTS ON FORM 8-K
None
12
<PAGE> 13
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.
<TABLE>
<S> <C>
ANTEX BIOLOGICS INC.
---------------------------------------------
(Registrant)
Date: May 11, 1998 /s/V. M. Esposito
---------------------------------------------
V. M. Esposito, President and
Chief Executive Officer
(Principal Executive Officer)
Date: May 11, 1998 /s/Gregory C. Zakarian
---------------------------------------------
Gregory C. Zakarian, Vice President,
and Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer)
</TABLE>
13
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> MAR-31-1998
<CASH> 5,439,216
<SECURITIES> 0
<RECEIVABLES> 528,855
<ALLOWANCES> 0
<INVENTORY> 0
<CURRENT-ASSETS> 6,128,480
<PP&E> 2,850,586
<DEPRECIATION> (2,342,000)
<TOTAL-ASSETS> 6,866,471
<CURRENT-LIABILITIES> 874,826
<BONDS> 0
0
0
<COMMON> 224,803
<OTHER-SE> 5,330,727
<TOTAL-LIABILITY-AND-EQUITY> 6,866,471
<SALES> 0
<TOTAL-REVENUES> 1,079,495
<CGS> 0
<TOTAL-COSTS> 1,408,544
<OTHER-EXPENSES> (68,039)
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (261,010)
<INCOME-TAX> 0
<INCOME-CONTINUING> 0
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (261,010)
<EPS-PRIMARY> (.01)
<EPS-DILUTED> (.01)
</TABLE>
