UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended December 31, 1996
-----------------
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
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Commission File Number 0-20968
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Advanced Mammography Systems, Inc.
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(Exact name of registrant as specified in its charter)
Delaware 04-3166348
------------------------------ ----------------------
(State or other jurisdiction (IRS Employer Identification
of incorporation or Number)
organization)
46 Jonspin Road, Wilmington, Massachusetts 01887
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(Address or principal executive offices) (Zip Code)
(508) 657-8876
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(Registrant's telephone number, including area code)
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
----
As of January 31, 1997, there were 8,346,740 shares of Common
Stock, $.01 par value, outstanding.
AMENDMENT NO. 1
The undersigned registrant hereby amends the following items,
financial statements, exhibits or other portions of its Form 10-Q
for the quarterly period ended December 31, 1996 as set forth in the
pages attached hereto:
(List all such items, financial statements, exhibits or other
portions amended)
1. Items 1 and 2 Financial Statements and Management's
Discussion and Analysis - Amended to reflect a change in
accounting for the May 1996 issuance of the convertible
debentures. (See Note 1 in NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (UNAUDITED))
<PAGE>
ADVANCED MAMMOGRAPHY SYSTEMS, INC.
---------------------------------------
INDEX
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PART I. FINANCIAL INFORMATION Page No.
--------------------- --------
Item 1. Financial Statements
Balance Sheets - December 31, 1996 and 3
September 30, 1996
Statements of Operations - Quarters Ended 4
December 31, 1996 and December 31, 1995
and for the period from July 2, 1992
(inception) to December 31, 1996
Statements of Cash Flows - Quarters Ended 5
December 31, 1996 and December 31, 1995
and for the period from July 2, 1992
(inception) to December 31, 1996
Notes to Financial Statements 6-10
Item 2. Management's Discussion and Analysis of 11-12
Financial Condition and Results of
Operations
PART II. OTHER INFORMATION
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Signatures 13
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2
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FORM 10-Q/A
PART 1 FINANCIAL INFORMATION
Item 1 Financial Statements
ADVANCED MAMMOGRAPHY SYSTEMS, INC.
(A COMPANY IN THE DEVELOPMENT STAGE)
BALANCE SHEETS
--------------
December 31, September
1996 30,
(Unaudited) 1996
------------- -----------
ASSETS
-------
CURRENT ASSETS
--------------
Cash and cash equivalents $1,283,766 $1,997,076
Inventory 1,174,976 1,123,404
Other current assets 8,000 27,204
----------- ----------
TOTAL CURRENT ASSETS 2,466,742 3,147,684
Equipment- at cost, net of accumulated
depreciation of $367,072 and
$335,277 at December 31, 1996 and 646,926 611,432
September 30, 1996, respectively
Patent- at cost, net of amortization
of $8,526 and $7,060 at December 31,
1996 and September 30, 1996 23,194 24,661
Debt issue cost 177,430 200,574
---------- ---------
TOTAL ASSETS $3,314,292 $3,984,351
========== ==========
LIABILITIES AND STOCKHOLDERS' EQUITY
-------------------------------------
CURRENT LIABILITIES
-------------------
Accounts payable & accrued expenses $87,538 $184,785
Compensation payable 48,013 52,259
Accounts payable to parent company 1,083,035 671,551
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TOTAL CURRENT LIABILITIES 1,218,586 908,595
--------- ----------
Notes Payable 1,482,164 1,471,751
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TOTAL LIABILITIES 2,700,000 2,380,346
STOCKHOLDERS' EQUITY
--------------------
Preferred stock, $.01 par value,
5,000,000 shares authorized none
issued - -
Common stock, $.01 par value,
authorized 25,000,000 shares;
issued 8,346,740 and 8,346,740 83,467 83,467
Additional paid in capital 14,368,543 14,368,543
Deficit accumulated during the
development stage (13,838,468)(12,848,005)
----------- -----------
TOTAL STOCKHOLDERS' EQUITY 613,542 1,604,005
----------- -----------
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY
$3,314,292 $3,984,351
=========== ==========
See notes to financial statements
3
<PAGE>
FORM 10-Q/A
ADVANCED MAMMOGRAPHY SYSTEMS, INC.
(A COMPANY IN THE DEVELOPMENT STAGE)
STATEMENTS OF OPERATIONS
-------------------------
(UNAUDITED)
-----------
CUMULATIVE FROM
QUARTERS ENDED JULY 2, 1992
-------------- (INCEPTION DATE)
DECEMBER 31, DECEMBER 31, TO DECEMBER 31,
----------- ----------- 1995
1996 1995 ---------------
------ ------
COST AND EXPENSES
Acquired technology $ - $ - $1,720,000
Research & development 455,767 221,824 4,182,629
General & administrative 532,062 432,110 6,302,358
------- -------- ----------
LOSS FROM OPERATIONS ( 987,829) (653,934) (12,204,987)
Amortization of debt
issuance cost ( 23,143) -- ( 364,962)
Interest expense -- -- ( 1,599,999)
Interest & other income 20,509 12,106 331,480
---------- ---------- ------------
NET LOSS AND DEFICIT
ACCUMULATED DURING
DEVELOPMENT STAGE $( 990,463) $( 641,828) $(13,838,468)
========== ========== =============
NET LOSS PER SHARE $( .18 ) $( .07 )
========== ===========
Weighted average number
of common shares
outstanding 5,596,740 3,848,376
========= =========
See notes to financial statements.
4
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FORM 10-Q/A
ADVANCED MAMMOGRAPHY SYSTEMS, INC.
(A COMPANY IN THE DEVELOPMENT STAGE)
STATEMENTS OF CASH FLOWS
------------------------
(UNAUDITED)
-----------
QUARTERS ENDED
----------------
DECEMBER 31, DECEMBER 31
----------- -----------
1996 1995
----- -----
CASH FLOWS FROM OPERATING ACTIVITIES:
Net (Loss) $( 990,463) $( 641,828)
------------ -----------
Adjustments to reconcile net loss to
net cash flows from operating
activities:
Depreciation and amortization 43,676 28,283
Amortization of debt issuance cost 23,143 -
Amortization of discount related
to issuance of convertible
debentures (Note 7) - -
Common stock issued for technology
rights - -
Changes in assets and liabilities:
Inventories ( 51,572) ( 50,642)
Other current assets 19,204 -
Accounts payable & accrued expenses ( 97,247) ( 11,312)
Other current liabilities 407,238 246,024
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Total adjustments 344,442 212,353
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NET CASH (USED) FOR OPERATING ( 646,021) ( 429,475)
ACTIVITIES: ----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Patent costs - ( 798)
Net additions to furniture, equipment,
and leasehold improvements ( 67,289) -
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NET CASH (USED) FOR INVESTING
ACTIVITIES:
CASH FLOWS FROM FINANCING ACTIVITIES:
Payment of notes payable - -
Proceeds from notes payable & warrants - -
Public offering of stock, net - -
Sale of unit purchase option - -
Debt issuance cost - -
Costs of public offering
Exercise of stock options - -
Exercise of stock warrants - -
----------- ---------
NET CASH PROVIDED BY FINANCING
ACTIVITIES: 0 0
----------- ---------
CASH AND CASH EQUIVALENTS:
Net increase (decrease) ( 713,310) ( 430,273)
Balance, beginning of period 1,997,076 1,832,563
------------ ------------
Balance, end of period $1,283,766 $1,402,290
========== ===========
CUMULATIVE FROM
JULY 2, 1992
(Inception Date)
TO DECEMBER 31,
1996
-----------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net (Loss) $(13,838,468)
------------
Adjustments to reconcile net loss to net
cash flows from operating activities:
Depreciation and amortization 1,143,766
Amortization of debt issuance cost 105,825
Amortization of discount related to
issuance of convertible debentures
(Note C) 1,000,000
Common stock issued for technology
rights 40,000
Changes in assets and liabilities:
Inventories ( 1,174,976)
Other current assets ( 8,000)
Accounts payable & accrued expenses 87,538
Other current liabilities 1,131,048
----------
Total adjustments 1,325,201
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NET CASH (USED) FOR OPERATING (11,513,267)
ACTIVITIES: -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Patent costs ( 31,721)
Net additions to furniture, equipment,
and leasehold improvements ( 1,013,997)
------------
NET CASH (USED) FOR INVESTING
ACTIVITIES: (1,045,718)
Payment of notes payable 2,000,000
Proceeds from notes payable & warrants 5,000,000
Public offering of stock, net 8,901,000
Sale of unit purchase option 129
Debt issuance cost ( 530,962)
Costs of public offering ( 1,436,617)
Exercise of stock options 40,000
Exercise of stock warrants 3,869,201
-----------
NET CASH PROVIDED BY FINANCING
ACTIVITIES: 13,842,751
-----------
CASH AND CASH EQUIVALENTS:
Net increase (decrease) 1,283,766
Balance, beginning of period -
------------
Balance, end of period $1,283,766
==========
See notes to financial statements.
5
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FORM 10-Q/A
NOTES TO FINANCIAL STATEMENTS (UNAUDITED)
-----------------------------------------
NOTE 1 - BASIS OF PRESENTATION
------------------------------
The accompanying financial statements have been restated to
include adjustments to the September 30, 1996 balances of additional
paid in capital and deficit accumulated during the development stage
to reflect a change in accounting for the May 1996 issuance of
convertible debentures whereby the beneficial conversion feature of
the debentures was recorded as additional interest expense.
This amended Form 10-Q should be read in conjunction with all
subsequent filings with the Securities and Exchange Commission which
disclose significant developments including a proposed merger of
Advanced Mammography Systems, Inc. ("AMS" or the "Company") and
Advanced NMR Systems, Inc. ("ANMR").
The results of operations for the interim periods shown in this
report are not necessarily indicative of results to be expected for the
fiscal year. In the opinion of management, the information contained
herein reflects all adjustments necessary to make the results of
operations for the interim periods a fair statement of such operations.
All such adjustments are of a normal recurring nature.
The accompanying financial statements do not contain all of the
disclosures required by generally accepted accounting principles and
should be read in conjunction with the financial statements and related
notes included in the Company's annual report on Form 10-K for the year
ended September 30, 1996.
NOTE 2 - THE COMPANY
--------------------
The Company is a development stage company which was organized in
Delaware in July 1992 to acquire and develop proprietary technology
from ANMR in order to design, manufacture and commercialize a dedicated
(or partial body) magnetic resonance imaging ("MRI") system for
breast imaging which can be used to detect and characterize breast
tissue abnormalities.
In February 1996, the U.S. Food and Drug Administration (the "FDA")
cleared the commercial use of the Company s AuroraTM dedicated MR Breast
Imaging System. In order to fully commercialize the Aurora System and to
demonstrate diagnostic effectiveness as an accepted tool for the
diagnosis and management of breast disease and permit reimbursement for
dedicated breast MRI by third parties such as Medicare, private insurance
and managed care consortiums, the Company must develop maximum clinical
utility. The Company has launched a clinical study which includes a
scientific investigation of the improved breast imaging device in a large
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patient population to provide objective evidence of its clinical utility.
The System has been placed at the University of Texas Medical Branch at
Galveston and the Company expects to install a second System at the
Faulkner-Sagoff Centre for Breast Health Care in Boston, MA for research
testing. It is anticipated that the breast imaging technology should
gain clinical acceptance over the next two years and continue to evolve
as further information is obtained from the clinical studies concerning
additional applications.
The Company completed its initial public offering ("IPO") in January
1993, selling 1,483,500 shares of Common Stock at a price of $6.00 per
share including 193,500 shares underlying an over-allotment option
exercised by the underwriter in March 1993. The public offering
generated cash proceeds of approximately $7,500,000 net of commissions
and other costs. The IPO proceeds were used for the repayment of debt,
for research and development and for working capital. In January 1995,
the Company called for redemption of all of its remaining outstanding
redeemable stock purchase warrants (the "Warrants") to purchase shares of
its Common Stock and received $2.3 million in proceeds. In May 1996,
the Company completed a private placement of $3 million of Convertible
Debentures. (See Note 7)
NOTE 3 - THE ANMR ESCROW SHARES
-------------------------------
In connection with the Company's January 1993 public offering, ANMR,
which was the sole stockholder of the Company, placed in escrow an
aggregate of 2,750,000 (the "Escrow Shares") of the 4,000,000 shares of
the Common Stock it owned. ANMR may vote the Escrow Shares, but cannot
assign or transfer them while they remain subject to the escrow.
All Escrow Shares not released from escrow will be forfeited and
contributed to the capital of the Company as a result of the Company's
failure to achieve certain financial milestones, which if achieved would
have resulted in the release of the Escrow Shares. The conditions for
the release of the Escrow Shares have not been met and it is expected
that the Escrow Shares will be returned to the Company as of May 1997.
Upon forfeiture of the Escrow Shares the Company will incur an expense
based on the fair market value of the Company's Common Stock and ANMR s
interest in the Company will be reduced to approximately 20%.
The Company believes that its transaction with ANMR described above
was on terms not less favorable to the Company than the terms that would
have been available from unaffiliated parties under similar
circumstances. Actual comparisons with other transactions are not
possible, however.
7
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NOTE 4 - THE SHARED SERVICES AGREEMENT
--------------------------------------
To optimize the Company's and ANMR's operating efficiency, the
Company and ANMR entered into a Shared Services Agreement as of January
25, 1993, whereby the companies share common expenses and functions, for
example, executive officers, marketing, field service, administration,
regulatory approvals and outside services. On August 29, 1996, the
original Agreement dated January 25, 1993, was terminated and the Company
and ANMR entered into a new agreement which outlines a more accurate
method of allocating the services that are shared by the companies. The
new agreement has developed as a result of two significant factors: (a)
the changes in the company profile of ANMR which is modifying its
technology operations related to the manufacture of its InstaScan
retrofit system and is attending to its service divisions, and (b) the
growing independence of both companies as each company pursues divergent
objectives. Vendors for parts and services have been instructed to
provide separate invoices directly to the Company or ANMR, as the case
may be. The Company s expenses related to the use of the facilities,
such as rent, utilities and insurance, will be apportioned based on the
number of square feet occupied by the Company or ANMR, respectively. The
remaining expenses, including senior management, administration and
miscellaneous supplies and resources, will be allocated equitably between
the companies, but will be modified as circumstances dictate.
NOTE 5 - THE ANMR LICENSE AGREEMENT
-----------------------------------
In June 1992, the Company entered into the ANMR License Agreement
with ANMR pursuant to which the Company was granted a perpetual,
worldwide exclusive, royalty-free license to all proprietary technology
and related know-how, including patents owned and/or licensed by ANMR and
patent applications filed or to be filed by ANMR (the "Licensed
Technology"), to the extent, if any, useful in connection with developing
a dedicated MRI system for mammography (the "Field of Use").
The Company believes other dedicated use (or partial body) MRI
scanners might be developed for fields of use in addition to breast
imaging. The Company has not been granted the right to use any
technology now or hereafter obtained by the Company from ANMR in
connection with any other dedicated use MRI scanners. However, the
Company has been granted a 50% interest in any entity which may be
organized by ANMR to develop dedicated use MRI scanners outside the Field
of Use ("ANMR Entity") and a 50% interest in any net profits, as defined
in the ANMR License Agreement (after allocation of development expense),
derived by ANMR from the sale or license of dedicated use MRI scanners
utilizing or based upon the Licensed Technology outside the Field of Use.
The ANMR License Agreement provides that (i) any inventions outside the
Field of Use developed solely by ANMR or an ANMR entity shall be owned by
ANMR or such ANMR entity and automatically licensed to the Company on an
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exclusive, worldwide basis, within the Field of Use, and (ii) any
inventions developed solely by the Company shall be automatically
licensed to ANMR on an exclusive worldwide basis for use solely outside
the Field of Use, and (iii) any inventions outside the Field of Use
jointly developed by the Company and ANMR or an ANMR entity shall be
jointly owned in equal shares by the Company, on the one hand, and ANMR
or an ANMR Entity, on the other hand, and AMS or an ANMR entity shall
automatically license its interest to ANMR on an exclusive, worldwide
basis. Accordingly, ANMR shall obtain the right to future technology
developed by AMS for use in connection with breast imaging, and the
Company shall obtain the right to further technology developed by the
Company for use outside the Field of Use.
Neither party may assign its rights under the ANMR License Agreement
without the prior written consent of the other party, except that either
party may transfer, assign or sublicense its rights under the ANMR
License Agreement in connection with disposing of any entire product
line, subcontracting to a third party the development, manufacture or
sale of a particular product, granting to a third party the right to
manufacture, develop or sell a particular product in any territory within
or without the United States, or, in the case of the Company, a transfer
of all of its rights to the Licensed Technology to a single entity.
On August 6, 1996, ANMR announced that it has eliminated research,
development and production of its InstaScan technology. Restructuring of
ANMR could have an impact on the future availability of ANMR scientific
personnel under the Shared Services Agreement and its related technology
before the period under the ANMR License Agreement.
NOTE 6 - THE AURORA BREAST IMAGING SYSTEM
------------------------------------------
The Company intends to market its MRI breast imaging products or
components thereof, either directly to hospitals and clinics or through a
marketing or joint venture arrangement with one or more distributors.
In February 1996, the Company was granted a 510(k) clearance by the
FDA for the purpose of commercial distribution of the Aurora System. To
accelerate the establishment of MR's clinical efficacy and cost
effectiveness in the diagnosis of breast diseases, in addition to its
arrangements with its two current institutions, the Company is partnering
under terms currently in negotiations with other leading institutions to
conduct rigorous and scientifically sound clinical and economic outcome
comparisons between MR breast imaging and mammography. This marketing
effort will fuel a comprehensive sales campaign, including advertising,
trade shows, application training and other activities as appropriate.
The Company installed the first Aurora System at the Breast Imaging
Center at the University of Texas Medical Branch at Galveston, Texas in
February 1996. The second installation of the Aurora System will be at
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the world renowned Sagoff Centre at Faulkner Hospital, Boston, MA in
April 1997.
NOTE 7 - PRIVATE PLACEMENT OF CONVERTIBLE DEBENTURES
----------------------------------------------------
In May 1996, the Company closed a Regulation S private placement
(the "Placement") of $3 million principal amount 4% Convertible
Debentures of the Company (the "Debentures") due December 1, 1998 (the
"Maturity Date"). The Debentures accrue interest at the rate of 4% per
annum from the date of issuance to the Maturity Date, or earlier either
upon conversion or prepayment. Upon conversion, the Company has the
option to pay the accrued interest on the Debentures being converted in
shares of its Common Stock at the then conversion rate. At December 31,
1996, approximately $1,482,000 of Debentures was still outstanding after
certain conversions. The net proceeds of the Placement of approximately
$2,750,000, after payment of fees and related expenses, is being used for
completion of product development of the Company s Aurora System, the
commercialization and marketing of the Aurora System and working capital.
In connection with the Placement, the Company issued to the
placement agents for the Debentures, warrants for the purchase of 197,500
shares of the Company's Common Stock at an exercise price of $2.20 per
share for a period or eighteen months and warrants for an additional
197,500 shares of Common Stock at an exercise price of $2.50 per share
for a period of five years.
NOTE 8 - PRIVATE PLACEMENT OF STOCK AND WARRANTS
------------------------------------------------
On February 6, 1997, the Company sold an aggregate of 1,219,514
shares of Common Stock and three year warrants to purchase 1,219,514
shares of Common Stock at an exercise price of $1.93 per share for
$1,500,000. These placements were in accordance with Regulation S and
Regulation D under the Securities Act of 1933. In connection with the
placements, the Company issued to the placement agent three year warrants
for the purchase of 121,951 shares of Common Stock at an exercise price
of $1.68 per share and paid 11-1/4% in fees and expenses.
10
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FORM 10-Q/A
ITEM 2
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
---------------------------------------------------------------
RESULTS OF OPERATIONS
---------------------
The following discussion should be read in conjunction with the
attached notes hereto, and with the audited financial statements and
notes thereto for the year ended September 30, 1996.
RESULTS OF OPERATIONS
---------------------
The Company was formed in July 1992 and is in the development stage.
Through December 31, 1996, the Company had not derived any revenues from
operations, although it has placed the first breast imaging system at a
customer Beta site in Galveston, Texas and expects to receive payment for
this system in fiscal 1997. As a result of charging operations with the
cost of its technology license acquired from ANMR, as well as salaries
and consulting fees of persons engaged in research and development
activities, the Company had an accumulated deficit of $13,838,000 at
December 31, 1996. Of such deficit, $1,720,000 represented the purchase
price of rights to certain technology transferred to the Company by ANMR
in 1992.
Total operating expenses for the three months of fiscal 1997 were
$988,000, an increase of 51% compared to $654,000 in the same period in
fiscal 1996.
Research and development expense was $456,000 in the first three
months of fiscal 1997, an increase of 105% compared with $222,000 in the
same period in fiscal 1996. The increase is due to the addition of
technical personnel assigned to complete the R&D effort. The Company
expects research and development expense to stabilize at this level
through fiscal 1997.
General & administrative expense for the first three months of
fiscal 1997 was $532,000 versus $432,000 for the same period in fiscal
1996. The increase is due primarily to additional personnel responsible
for clinical applications, customer support and regulatory and compliance
management.
LIQUIDITY AND CAPITAL RESOURCES
-------------------------------
At December 31, 1996 the Company had working capital of $1,248,000
including available cash of $1,284,000. The Company expects to continue
to incur substantial expenditures for development, marketing, and
clinical studies of the breast imaging system.
The Company believes its existing cash reserves, including the
proceeds of from the May 1996 Debentures and the February 1997 placements
(see Item 1 Notes 7 and 8) are adequate to fund its operating activities
11
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for the next nine months. The Company is seeking to obtain additional
funds through debt or additional equity placements. The February 1997
placements were made pursuant to a funding agreement among the Company,
placement agent and a potential lender. The funding agreement provides
for short term convertible debt financing not to exceed $10 million on
mutually agreed terms. The parties are conducting negotiations, however,
there is no assurance that these negotiations will result in any
financing or that the terms would be not dilutive to present
stockholders.
The Company is including the following cautionary statement in its
Report on Form 10-Q to make applicable and take advantage of the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995
for any forward-looking statements made by, or on behalf of the Company.
Forward-looking statements include statements concerning plans,
objectives, goals, strategies, future events or performance and
underlying assumptions and other statements which are other than
statements of historical facts. Certain statements contained herein are
forward looking statements and accordingly involve risks and
uncertainties which could cause actual results or outcomes to differ
materially from those expressed in the forward-looking statements. The
Company's expectations, beliefs and projects are expressed in good faith
and are believed by the Company to have a reasonable basis, including
without limitations, management's examination of historical operating
trends, data contained in the Company's records and other data available
from third parties, but there can be no assurance that management's
expectations, beliefs or projections will result or be achieved or
accomplished. In addition to other factors and matters discussed
elsewhere herein, the following are important factors that, in the view
of the Company, could cause actual results to differ materially from
those discussed in the forward-looking statements: technological
advances by the Company's competitors, changes in health care reform,
including reimbursement programs, capital needs to fund any delays or
extensions of research programs, delays in product development, lack of
market acceptance of technology and the availability of capital on terms
satisfactory to the Company. The Company disclaims any obligation to
update any forward-looking statements to reflect events or circumstances
after the date hereof.
12
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FORM 10-Q/A
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.
Advanced Mammography Systems, Inc.
----------------------------------
(Registrant)
Date: August 4, 1997 /s/ Steven J. James
--------------------------------
Steven J. James
Chief Financial Officer
13
