<PAGE>
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
FORM 10-Q
[x] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934
FOR THE QUARTER ENDED JUNE 30, 1997
or
[ ] Transition report pursuant to Section 13 or 15(d) of Securities Exchange
Act of 1934
Commission file number 1-14430
MAXIM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware 87-0279983
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(State of incorporation) (I.R.S. Employer Identification No.)
3099 Science Park Road, Suite 150, San Diego, CA 92121
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(Address of principal executive offices) (Zip Code)
(619) 453-4040
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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 August 1, 1997, the registrant had 6,671,246 shares of Common Stock, $.001
par value, outstanding.
<PAGE>
MAXIM PHARMACEUTICALS, INC.
(A Development Stage Company)
INDEX
PART I - FINANCIAL INFORMATION PAGE
- ------------------------------ ----
Item 1. Financial Statements
Balance Sheets -
June 30, 1997 (unaudited) and September 30, 1996. . . . . . 1
Statements of Operations (unaudited) -
Three Months and Nine Months Ended June 30, 1997
and 1996, and from Inception (October 23, 1989)
through June 30, 1997 . . . . . . . . . . . . . . . . . . . 2
Statements of Cash Flows (unaudited) -
Nine Months Ended June 30, 1997 and 1996
and from Inception (October 23, 1989) through
June 30, 1997 . . . . . . . . . . . . . . . . . . . . . . . 3
Notes to Financial Statements . . . . . . . . . . . . . . . 4
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations . . . . . . . 5
PART II - OTHER INFORMATION
- ---------------------------
Item 1. Legal Proceedings . . . . . . . . . . . . . . . . . . . . . 7
Item 6. Exhibits and Reports on Form 8-K. . . . . . . . . . . . . . 7
SIGNATURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
<PAGE>
BALANCE SHEETS
MAXIM PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY)
<TABLE>
<CAPTION>
JUNE 30, 1997 September 30, 1996
------------- ------------------
ASSETS (UNAUDITED)
<S> <C> <C>
CURRENT ASSETS:
Cash and cash equivalents $ 170,091 $ 4,070,089
Short-term investments in marketable securities 10,887,863 12,563,622
Accrued interest and other current assets 549,247 709,285
-------------- -----------------
Total current assets 11,607,201 17,342,996
Investments in marketable securities 3,216,603 2,510,366
Patents and licenses, net 1,807,048 1,367,235
Property and equipment, net 681,898 31,037
Deposits 203,396 3,397
-------------- -----------------
Total assets $ 17,516,146 $ 21,255,031
-------------- -----------------
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable $ 480,050 $ 405,760
Accrued expenses 549,599 478,623
Current portion of long-term debt 78,317 247,000
-------------- -----------------
Total current liabilities 1,107,966 1,131,383
Long-term debt, less current portion 548,216 -
STOCKHOLDERS' EQUITY:
Preferred stock, $.001 par value, 5,000,000 shares authorized - -
Common stock, $.001 par value, 20,000,000 shares authorized;
6,671,246 and 6,671,237 shares issued and outstanding at
June 30, 1997 and September 30, 1996, respectively. 6,672 6,672
Additional paid-in capital 34,172,686 34,172,618
Deficit accumulated during the development stage (18,251,524) (13,936,903)
Deferred compensation (67,870) (118,739)
-------------- -----------------
Total stockholders' equity 15,859,964 20,123,648
-------------- -----------------
Total liabilities and stockholders' equity $ 17,516,146 $ 21,255,031
-------------- -----------------
</TABLE>
SEE NOTES TO FINANCIAL STATEMENTS
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STATEMENTS OF OPERATIONS (UNAUDITED)
MAXIM PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended October 23, 1989
June 30 June 30 (inception) to
1997 1996 1997 1996 June 30, 1997
-------------- ------------ -------------- ------------ ---------------
<S> <C> <C> <C> <C> <C>
Operating expenses:
Product development $ 1,538,480 $ 341,777 $ 3,293,528 $ 1,078,306 $ 13,294,786
Business development 121,716 23,825 284,895 79,810 346,895
General and administrative 493,331 482,883 1,394,716 946,727 8,920,523
-------------- ------------ -------------- ------------ ---------------
Total operating expenses 2,153,527 848,485 4,973,139 2,104,843 22,562,204
Other income (expense):
Investment income 226,982 11,531 732,142 22,843 1,019,872
Interest expense (27,964) (24,042) (60,269) (176,667) (1,964,078)
Other expense 1,066 (24,414) (13,355) (119,631) (115,143)
Research grant revenue - - - - 2,946,001
Gain on sale of subsidiary - - - - 2,288,474
-------------- ------------ -------------- ------------ ---------------
Total other income (expense) 200,084 (36,925) 658,518 (273,455) 4,175,126
-------------- ------------ -------------- ------------ ---------------
Discontinued operations:
Loss from operation of discontinued
diagnostic division - - - - (347,608)
Gain on sale of diagnostic division - - - - 483,162
-------------- ------------ -------------- ------------ ---------------
Net loss $ (1,953,443) $ (885,410) $ (4,314,621) $(2,378,298) $ (18,251,524)
-------------- ------------ -------------- ------------ ---------------
Net loss per share of common stock $ (0.29) $ (0.14) $ (0.65) $ (0.42)
-------------- ------------ -------------- ------------
Weighted average shares outstanding 6,671,246 6,154,752 6,671,240 5,655,594
-------------- ------------ -------------- ------------
SEE NOTES TO FINANCIAL STATEMENTS
</TABLE>
2
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<TABLE>
<CAPTION>
Nine Months Ended
June 30 October 23, 1989
------------------------------- (inception) to
1997 1996 June 30, 1997
--------------- -------------- -----------------
<S> <C> <C> <C>
OPERATING ACTIVITIES:
Net loss $ (4,314,621) $ (2,378,298) $(18,251,524)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 180,787 27,113 961,931
Amortization of premium on investments 123,664 - 123,664
Stock options issued as compensation 50,869 249,568 327,129
Gain on sale of subsidiary - - (2,288,474)
Loss on write-off of patents 53,339 - 242,407
Loss on disposal of property & equipment - 128,248 128,248
Loss on write-off of receivable from related party - 100,000 147,803
Other - - 27,032
Write-off of obsolete inventory - - 24,669
Gain on sale of diagnostic division - - (483,162)
Loss on write-off of purchased research
and development - - 2,646,166
Cumulative effect of reorganization - - 1,152,667
Changes in operating assets and liabilities:
Accrued interest and other current assets 160,038 12,376 (549,247)
Other assets (200,000) 16,141 (351,200)
Accounts payable 74,291 (55,220) 480,051
Accrued expenses 70,974 - 570,807
------------- -------------- ---------------
Net cash used in operating activities (3,800,659) (1,900,072) (15,091,033)
INVESTING ACTIVITIES:
Purchases of marketable securities (10,340,141) - (25,414,129)
Maturities of marketable securities 11,186,000 - 11,186,000
Additions to patents (603,377) (145,227) (2,446,164)
Purchases of property and equipment (721,422) (13,838) (1,529,663)
Cash acquired in acquisition of business - - 985,356
Proceeds from sale of diagnostic division - - 496,555
------------- -------------- ---------------
Net cash used by investing activities (478,940) (159,065) (16,722,045)
FINANCING ACTIVITIES:
Proceeds from issuance of notes payable and
long term debt 626,533 - 5,202,956
Payments on notes payable and long-term debt (247,000) (2,141,293) (3,017,505)
Proceeds from issuance of notes payable to
related parties - (106,000) 4,982,169
Payments on notes payable to related parties - - (1,329,885)
Net proceeds from issuance of common stock
and warrants 68 5,706,795 25,657,934
Net proceeds from issuance of preferred stock - - 487,500
------------- -------------- ---------------
Net cash provided by financing activities 379,601 3,459,502 31,983,169
------------- -------------- ---------------
Net increase (decrease) in cash and cash equivalents (3,899,998) 1,400,365 170,091
Cash and cash equivalents at beginning of period 4,070,089 512,928 -
------------- -------------- ---------------
Cash and cash equivalents at end of period $ 170,091 $ 1,913,293 $ 170,091
------------- -------------- ---------------
</TABLE>
SEE NOTES TO FINANCIAL STATEMENTS.
3
<PAGE>
NOTES TO FINANCIAL STATEMENTS (UNAUDITED)
MAXIM PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY)
1. PRINCIPLES OF INTERIM PERIOD REPORTING
Maxim Pharmaceuticals, Inc. (the "Company") has not earned significant revenues
from planned principal operations. Accordingly, the Company's activities have
been accounted for as those of a "Development Stage Enterprise" as set forth in
Financial Accounting Standards Board Statement No. 7 ("FAS 7").
In the opinion of the Company, the unaudited financial statements contain all of
the adjustments, consisting only of normal recurring adjustments and accruals,
necessary to present fairly the financial position of the Company as of June 30,
1997 and September 30, 1996, and the results of operations for the three months
and nine months ended June 30, 1997 and 1996 and from inception (October 23,
1989) to June 30, 1997. The results of operations for the three months and nine
months ended June 30, 1997 are not necessarily indicative of the results to be
expected in subsequent periods or for the year as a whole. For further
information, refer to the consolidated financial statements and footnotes
thereto for the year ended September 30, 1996.
2. LINE OF CREDIT AGREEMENT AND NOTE PAYABLE
LINE OF CREDIT AGREEMENT - In March 1997 the Company entered into a line of
credit agreement with a bank. Under the agreement the Company may borrow up to
$900,000 during 1997 to fund qualified equipment purchases. At January 1, 1998
any outstanding advances under the line of credit will convert to a term loan
payable in equal installments over 48 months, including interest at prime plus
0.5%. The loan is secured by all assets of the Company. At June 30, 1997,
aggregate advances under the line of credit totaled $626,533.
NOTE PAYABLE - In July 1993, the Company issued a note payable to a company for
$600,000 in partial consideration for certain worldwide exclusive rights related
to its Maxamine-TM- technology. In June 1997, the Company made the final
payment of principal of $247,000 due under the note.
3. CONTINGENCY
In March 1997 the former President and Chief Operating Officer and Chief
Financial Officer of the Company (the "Former Employees") filed a complaint
in the Superior Court in the State of California, County of San Diego (the
"Complaint") seeking claims for certain purported damages in contract and in
tort arising from their respective terminations of employment with the
Company. In addition, the Former Employees asserted possible punitive damages
and damages based on emotional distress. The Former Employees also claimed
the right to vested options of the Company's common stock. The aggregate
amount of economic damages, punitive damages and damages based on emotional
distress claimed by the Former Employees in the Complaint approximated $14
million. Although the Company's intention is to contest any such claims
vigorously, there can be no assurances as to the eventual outcome of such
claims or their effect on the Company's financial condition and results of
operations. In addition, an adverse determination in any litigation arising
from these claims or the settlement of such claims could have a material
adverse effect on the Company, its financial condition and its results of
operations.
4
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
MAXIM PHARMACEUTICALS, INC. (A DEVELOPMENT STAGE COMPANY)
THIS MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS THAT INVOLVE RISKS AND
UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE
ANTICIPATED IN THESE FORWARD-LOOKING STATEMENTS. FACTORS THAT MAY CAUSE SUCH
DIFFERENCES INCLUDE, BUT ARE NOT LIMITED TO, THOSE DISCUSSED UNDER "RISK
FACTORS" AND ELSEWHERE IN THE COMPANY'S ANNUAL REPORT ON FORM 10-K FOR THE YEAR
ENDED SEPTEMBER 30, 1996, AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION,
INCLUDING THE UNCERTAINTIES ASSOCIATED WITH PRODUCT DEVELOPMENT, THE RISK THAT
PRODUCTS THAT APPEARED PROMISING IN EARLY CLINICAL TRIALS DO NOT DEMONSTRATE
EFFICACY IN LARGER-SCALE CLINICAL TRIALS, THE RISK THAT CLINICAL TRIALS WILL NOT
COMMENCE WHEN PLANNED, RISKS RELATED TO REGULATORY APPROVAL OF THE COMPANY'S
PRODUCT, AND THE RISK THAT THE COMPANY WILL NOT BE ABLE TO COMPLETE CORPORATE
COLLABORATIONS.
RESULTS OF OPERATIONS FOR THE THREE MONTHS AND NINE MONTHS ENDED JUNE 30, 1997
AND 1996
PRODUCT DEVELOPMENT EXPENSES - For the quarter ended June 30, 1997, product
development expenses were $1,538,480, an increase of $1,196,703, or 350%, over
the same period in the prior year. This increase was primarily attributable to
increased activity related to cancer clinical trials of the Company's
MAXAMINE-TM- therapy, including hiring additional clinical and development
personnel, contract research organization costs, and consulting and other costs
associated with commencement in June 1997 of Phase III clinical trials in the
United States. The current quarter increase also resulted from increased
efforts relating to preclinical development of the Company's MAXVAX-TM- mucosal
vaccine technology, including the addition of laboratory personnel and
establishment of internal research capabilities.
For the nine months ended June 30, 1997, product development costs were
$3,293,528, an increase of $2,215,222, or 205%, over the same period of the
prior year. The increase resulted from the Phase III clinical trial efforts and
the expansion of other product development activities described above.
BUSINESS DEVELOPMENT AND GENERAL AND ADMINISTRATIVE EXPENSES - For the quarter
ended June 30, 1997, business development expenses totaled $121,716, an increase
of $97,891 over the $23,825 in expense recorded in the same quarter in the prior
year. This increase was due to additional personnel and other resources devoted
to corporate partnering efforts and market evaluations. General and
administrative expenses for the quarter ended June 30, 1997 approximated that of
the prior year quarter and totaled $493,331.
Business development costs for the nine month period ended June 30, 1997 totaled
$284,895, an increase of $205,085, or 257%, over the same period of the prior
year as a result of the expanded activities described above. General and
administrative expenses for the nine month period ended June 30, 1997 increased
$447,989, or 47%, over the same period of the prior year to $1,394,716. This
increase is in a large part due to the increased personnel, insurance, reporting
and compliance costs associated with operation as a public company.
OTHER INCOME (EXPENSE) - Investment income was $226,982 for the quarter ended
June 30, 1997, compared to $11,531 for the same period in the prior year, due to
income on the proceeds of the Company's initial public offering completed in
July 1996. Similarly, investment income was $732,142 for the nine month period
ended June 30, 1997, compared to $22,843 for the same period in the prior year.
Interest expense was $60,269 compared to $176,667 for the nine month period in
the prior year. The current year decrease is due to the repayment of
approximately $2.85 million of notes payable and long-term debt subsequent to
December, 1995.
5
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NET LOSS - Net loss for the quarter ended June 30, 1997 totaled $1,953,443, a
121% increase over the prior year's third quarter loss of $885,410. This
increase is a result of the expanded product development and business
development discussed above. Net loss per share of common stock for the quarter
ended June 30, 1997 was $.29, a 107% increase from the prior years third quarter
loss of $.14 per share.
Net loss for the nine months ended June 30, 1997 totaled $4,314,621, an increase
of $1,936,323, or 81% over the same period of the prior year. Net loss per
share of common stock for the nine month period was $.65, a 55% increase over
the loss of $.42 per share for the same period of the prior year.
LIQUIDITY AND CAPITAL RESOURCES
The Company has financed its operations primarily through the sale of its equity
securities, including an initial public offering of common stock and redeemable
common stock purchase warrants in July 1996 which provided approximately $18.2
million, net of financing costs, to the Company.
As of June 30, 1997, the Company had cash, cash equivalents and investments
totaling approximately $14.3 million. For the nine months ended June 30,
1997, net cash used in the Company's operating activities was approximately
$3,801,000. The Company expects its cash requirements to increase
significantly in future periods as it conducts additional product development
activities including internal product research, development and testing,
preclinical studies and clinical testing of its potential products and
marketing of any products that are developed. Among the specific planned
activities which are expected to result in an increase in cash requirements
are the Phase III clinical trials commenced in June 1997 in the U.S. for the
MAXAMINE therapy and other planned clinical trials.
The Company's cash requirements may vary materially from those now planned
because of the results of research, development and clinical trials, the time
and costs involved in obtaining regulatory approvals, the cost of filing,
prosecuting, defending and enforcing patent claims and other intellectual
property rights, competing technological and market developments, changes in the
Company's existing research relationships, the ability of the Company to
establish collaborative arrangements and the development of the Company's
product commercialization activities. As a result of these factors, it is
difficult to predict accurately the timing and amount of the Company's cash
requirements.
In order to successfully commercialize any of its products, the Company expects
that it will ultimately be required to seek additional funds through public or
private financings or collaborative arrangements with corporate partners. The
issuance of additional equity securities could result in substantial dilution to
the Company's stockholders. There can be no assurance that additional funding
will be available on terms acceptable to the Company, if at all. The failure to
fund its capital requirements would have a material adverse effect on the
Company's business.
The Company has never paid a cash dividend and does not contemplate the payment
of cash dividends in the foreseeable future.
6
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PART II-OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
In March 1997 the former President and Chief Operating Officer and Chief
Financial Officer of the Company (the "Former Employees") filed a complaint
in the Superior Court in the State of California, County of San Diego (the
"Complaint") seeking claims for certain purported damages in contract and in
tort arising from their respective terminations of employment with the
Company. In addition, the Former Employees asserted possible punitive damages
and damages based on emotional distress. The Former Employees also claimed
the right to vested options of the Company's common stock. The aggregate
amount of economic damages, punitive damages and damages based on emotional
distress claimed by the Former Employees in the Complaint approximated $14
million. In May 1997 the Company was formally served with a summons
regarding the Complaint, and in June 1997 the Company answered the Complaint.
Although the Company's intention is to contest any such claims vigorously,
there can be no assurances as to the eventual outcome of such claims or their
effect on the Company's financial condition and results of operations. In
addition, an adverse determination in any litigation arising from these
claims or the settlement of such claims could have a material adverse effect
on the Company, its financial condition and its results of operations.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
a) EXHIBITS
EXHIBIT NUMBER DESCRIPTION OF EXHIBIT
- -------------- ----------------------
None None
b.) REPORTS ON FORM 8-K
DATE OF REPORT ITEM REPORTED FINANCIAL STATEMENTS FILED
- -------------- ------------- --------------------------
None None No
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.
Maxim Pharmaceuticals, Inc.
Date: August 1, 1997 /s/ Dale A. Sander
-----------------------------
Dale A. Sander
Chief Financial Officer
(Principal Accounting Officer and Officer
duly authorized to sign this report on
behalf of the registrant)
7
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE INTERIM
FINANCIAL STATEMENTS FOR THE PERIOD ENDED JUNE 30, 1997 AND IS QUALIFIED IN ITS
ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> SEP-30-1997
<PERIOD-START> OCT-01-1996
<PERIOD-END> JUN-30-1997
<CASH> 170,091
<SECURITIES> 10,887,863
<RECEIVABLES> 45,876
<ALLOWANCES> 45,876
<INVENTORY> 0
<CURRENT-ASSETS> 11,607,201
<PP&E> 777,609
<DEPRECIATION> 95,711
<TOTAL-ASSETS> (17,516,146)
<CURRENT-LIABILITIES> 1,107,966
<BONDS> 548,216
0
0
<COMMON> 6,672
<OTHER-SE> 15,853,292
<TOTAL-LIABILITY-AND-EQUITY> 17,570,667
<SALES> 0
<TOTAL-REVENUES> 0
<CGS> 0
<TOTAL-COSTS> 0
<OTHER-EXPENSES> 3,293,528
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 60,269
<INCOME-PRETAX> (4,314,621)
<INCOME-TAX> 0
<INCOME-CONTINUING> (4,314,621)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (4,314,621)
<EPS-PRIMARY> (.65)
<EPS-DILUTED> (.65)
</TABLE>
