UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended March 31, 1997
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _______ to _______
Commission File No. 0-20111
ARONEX PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
Delaware 76-0196535
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
3400 Research Forest Drive, The Woodlands, Texas 77381-4223
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (281) 367-1666
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 [ ]
Indicate the number of shares outstanding of each of the issuer's classes
of common stock as of the latest practicable date.
CLASS OUTSTANDING AT MARCH 31, 1997
- ----------------------------- -----------------------------
Common Stock, $.001 par value 14,644,816 shares
ARONEX PHARMACEUTICALS, INC.
QUARTERLY PERIOD MARCH 31, 1997
INDEX
PAGE
FACTORS AFFECTING FORWARD LOOKING STATEMENTS............................................................... 3
PART I. FINANCIAL INFORMATION
Item 1 Financial Statements.............................................................................. 3
Balance Sheets - December 31, 1996 and March 31, 1997 (unaudited)................................. 4
Statements of Operations:
Three Months Ended March 31, 1996 and March 31, 1997
(unaudited) and for the Period from Inception (June 13, 1986)
through March 31, 1997 (unaudited).............................................................. 5
Statements of Cash Flows:
Three Months Ended March 31, 1996 and March 31, 1997
(unaudited) and for the Period from Inception (June 13, 1986)
through March 31, 1997 (unaudited).............................................................. 6
Notes to Financial Statements - March 31, 1997.................................................... 7
Item 2 Management's Discussion and Analysis of Financial
Condition and Results of Operations............................................................. 9
PART II. OTHER INFORMATION
Item 6 Exhibits and Reports on Form 8-K.................................................................. 11
SIGNATURES................................................................................................. 12
EXHIBITS
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FACTORS AFFECTING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q includes "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. The words
"anticipate," "believe," "expect," "estimate," "project" and similar expressions
are intended to identify forward-looking statements. Such statements are
subject to certain risks, uncertainties and assumptions. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
expected, estimated or projected. For additional discussion of such risks,
uncertainties and assumptions, see "Item 1. Business -- Manufacturing," "--
Sales and Marketing," "-- Patents, Proprietary Rights and Licenses," "--
Government Regulation," "-- Competition" and "-- Additional Business Risks"
included in the Company's Annual Report on Form 10-K for the year ended December
31, 1996, and "Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations" and "-- Liquidity and Capital Resources"
included elsewhere in this report.
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
The following unaudited financial statements have been prepared
pursuant to the rules and regulations of the Securities and Exchange Commission.
Certain information and note disclosures normally included in annual financial
statements prepared in accordance with generally accepted accounting principles
have been condensed or omitted pursuant to those rules and regulations, although
the Company believes that the disclosures made herein are adequate to make the
information presented not misleading. These financial statements should be read
in conjunction with the financial statements for the year ended December 31,
1996 included in the Company's Annual Report on Form 10-K for the year ended
December 31, 1996, filed pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934.
The information presented in the accompanying financial statements is
unaudited, but in the opinion of management, reflects all adjustments (which
include only normal recurring adjustments) necessary to present fairly such
information.
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BALANCE SHEETS
(ALL AMOUNTS IN THOUSANDS, EXCEPT SHARE DATA)
ASSETS
MARCH 31,
DECEMBER 31, 1997
1996 (UNAUDITED)
------------- ------------
Current Assets:
Cash and cash equivalents........................................... $ 4,179 $ 3,047
Short-term investments.............................................. 30,414 27,068
Accounts receivable - affiliates.................................... 78 --
Prepaid expenses and other assets................................... 663 1,250
------------- ------------
Total current assets........................................... 35,334 31,365
Long-term investments................................................. 6,795 8,265
Furniture, equipment and leasehold improvements, net.................. 2,152 1,986
------------- ------------
Total assets................................................... $ 44,281 $ 41,616
============== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses............................... $ 1,191 1,440
Accrued payroll..................................................... 126 126
Advance payable to Genzyme.......................................... 2,000 2,000
Current portion of other notes payable.............................. 325 325
Current portion of obligations under capital leases................. 16 16
------------- ------------
Total current liabilities...................................... 3,658 3,907
Long-term obligations:
Other notes payable, net of current portion......................... $ 121 $ 62
Obligations under capital leases, net of current portion............ 25 21
------------- ------------
Total long-term obligations.................................... 146 83
Commitments and contingencies
Stockholders' equity:
Preferred stock $.001 par value, 10,000,000 shares authorized,
none issued and outstanding........................................ -- --
Common stock $.001 par value, 75,000,000 shares authorized,
14,597,247 and 14,664,816 shares issued and outstanding,
respectively....................................................... 15 15
Additional paid-in capital.......................................... 93,742 93,858
Common stock warrants............................................... 968 968
Treasury stock...................................................... (11) (11)
Deferred compensation............................................... (1,949) (1,792)
Unrealized loss on investments...................................... (75) (106)
Deficit accumulated during development stage........................ (52,213) (55,306)
------------- ------------
Total stockholders' equity..................................... 40,477 37,626
------------- ------------
Total liabilities and stockholders' equity..................... $ 44,281 $ 41,616
============= ============
The accompanying notes are an integral part of these financial statements.
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STATEMENTS OF OPERATIONS
(ALL AMOUNTS IN THOUSANDS, EXCEPT LOSS PER SHARE DATA)
(UNAUDITED)
PERIOD FROM
INCEPTION
(JUNE 13,
THREE MONTHS ENDED 1986)
MARCH 31, THROUGH
-------------------- MARCH 31,
1996 1997 1997
----------- ----------- -----------
Revenues:
Interest income...................... $ 142 $ 592 $ 4,114
Research and development grants
and contracts...................... 543 286 4,495
----------- ----------- -----------
Total revenues.................. 685 878 8,609
----------- ----------- -----------
Expenses:
Research and development............. 2,322 3,485 42,627
Purchase of in-process research
and development.................... -- -- 8,625
General and administrative........... 395 456 11,619
Interest expense..................... 41 30 1,044
----------- ----------- -----------
Total expenses.................. 2,758 3,971 63,915
----------- ----------- -----------
Net loss............................... $ (2,073) $ (3,093) $ (55,306)
=========== =========== ===========
Net loss per share..................... $ (0.19) $ (0.21)
=========== ===========
Weighted average shares used in
computing net loss per share......... 10,647 14,620
The accompanying notes are an integral part of these financial statements.
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STATEMENTS OF CASH FLOWS
(ALL AMOUNTS IN THOUSANDS)
(UNAUDITED)
PERIOD FROM
INCEPTION
(JUNE 13,
THREE MONTHS ENDED 1986)
MARCH 31, THROUGH
-------------------------- MARCH 31,
1996 1997 1997
------------ ----------- -----------
Cash flows from operating activities:
Net loss........................................................ $ (2,073) $ (3,093) $ (55,306)
Adjustments to reconcile net loss to net cash provided by
(used in) operating activities-
Depreciation and amortization 244 259 3,146
Compensation expense related to stock and stock options 131 193 2,835
Charge for purchase of in-process research and development -- -- 8,547
Unrealized loss on investment (50) (31) (106)
Acquisition costs, net of cash received -- -- (270)
Loss in affiliate 50 -- 500
Changes in assets and liabilities:
Decrease (increase) in prepaid expenses and other assets 108 (587) (1,065)
Decrease in accounts receivable - affiliates 165 78 --
Increase (decrease) in accounts payable and accrued
expenses (773) 249 1,493
Increase in deferred revenue 50 -- (353)
Accrued interest payable converted to stock -- -- 97
------------ ----------- -----------
Net cash used in operating activities (2,148) (2,932) (40,482)
Cash flows from investing activities:
Net sales (purchases) of investments 2,530 1,876 (29,598)
Purchase of furniture, equipment and leasehold improvements (38) (93) (3,862)
Investment in affiliate -- -- (500)
------------ ----------- -----------
Net cash provided by (used in) investing activities 2,492 1,783 (33,960)
Cash flows from financing activities:
Proceeds from notes payable -- -- 4,672
Repayment of notes payable and principal payments under capital
lease obligations (77) (63) (2,249)
Purchase of treasury stock -- -- (11)
Proceeds from issuance of stock 2,122 80 75,077
------------ ----------- -----------
Net cash provided by (used in) financing activities 2,045 17 77,489
------------ ----------- -----------
Net increase (decrease) in cash and cash equivalents 2,389 (1,132) --
Cash and cash equivalents at beginning of period 7,781 4,179 --
------------ ----------- -----------
Cash and cash equivalents at end of period $ 10,170 $ 3,047 $ 3,047
============ =========== ===========
Supplemental disclosures of cash flow information:
Cash paid during the period for interest $ 41 $ 20 $ 868
Supplemental schedule of noncash financing activities:
Conversion of notes payable and accrued interest to
common stock $ -- $ -- $ 3,043
The accompanying notes are an integral part of these financial statements.
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NOTES TO FINANCIAL STATEMENTS
MARCH 31, 1997
(UNAUDITED)
1. ORGANIZATION AND BASIS OF PRESENTATION
Aronex Pharmaceuticals, Inc. ("Aronex" or the "Company") was incorporated
in Delaware on June 13, 1986 and merged with Triplex Pharmaceutical Corporation
("Triplex") and Oncologix, Inc. ("Oncologix") effective September 11, 1995.
Aronex is a development stage company which has devoted substantially all of its
efforts to research and product development and has not yet generated any
significant revenues, nor is there any assurance of significant future
revenues. In addition, the Company expects to continue to incur losses for the
foreseeable future and there can be no assurance that the Company will complete
the transition from a development stage company to successful operations. The
research and development activities engaged in by the Company involve a high
degree of risk and uncertainty. The ability of the Company to successfully
develop, manufacture and market its proprietary products is dependent upon many
factors. These factors include, but are not limited to, the need for additional
financing, attracting and retaining key personnel and consultants, and
successfully developing manufacturing, sales and marketing operations. The
Company's ability to develop these operations may be impacted by uncertainties
related to patents and proprietary technologies, technological change and
obsolescence, product development, competition, government regulations and
approvals, health care reform and product liability exposure. Additionally, the
Company is reliant upon collaborative arrangements for research, contractual
agreements with corporate partners, and its exclusive license agreements with
M.D. Anderson Cancer Center ("MD Anderson") and an affiliate of Baylor College
of Medicine ("Baylor"). Further, during the period required to develop these
products, the Company will require additional funds which may not be available
to it. The Company expects that its existing cash resources will be sufficient
to fund its cash requirements through 1998. Accordingly, there can be no
assurance of the Company's future success.
The balance sheet at March 31, 1997 and the related statements of
operations and cash flows for the three month periods ending March 31, 1997 and
1996 and the period from inception (June 13, 1986) through March 31, 1997 are
unaudited. These interim financial statements should be read in conjunction
with the December 31, 1996 financial statements and related notes. The
unaudited interim financial statements reflect all adjustments which are, in the
opinion of management, necessary for a fair statement of results for the interim
periods presented and all such adjustments are of a normal recurring nature.
Interim results are not necessarily indicative of results for a full year.
2. ACCOUNTING POLICIES
In January 1997, the Financial Accounting Standards Board issued Statement
of Financial Accounting Standards No. 128, "Earnings per share" ("SFAS 128").
Management believes that this statement will have no material effect on its
financial statements.
3. CASH, CASH EQUIVALENTS AND INVESTMENTS
Cash and cash equivalents include money market accounts and investments
with an original maturity of less than three months. At March 31, 1997, all
short-term investments are held to maturity securities consisting of high-grade
commercial paper and U. S. Government backed securities with a carrying value of
$27,068,000, which approximates fair market value and cost. Long-term
investments include (i) held to maturity securities consisting of high-grade
commercial paper that mature over one to two years with a carrying value of
$6,500,000, which approximates fair market value and cost, and (ii) available
for sale securities which are U.S. mortgage backed securities with various
maturity dates over the next several years that have an amortized cost of
$1,871,000, a fair market value of $1,765,000 and a gross unrealized loss of
$106,000 at March 31, 1997. The Company currently has no trading securities.
-7-
4. FEDERAL INCOME TAXES
At December 31, 1996, the Company had net operating loss ("NOL")
carryforwards for federal income tax purposes of approximately $66.9 million.
The Tax Reform Act of 1986 provided a limitation on the use of NOL and tax
credit carryforwards following certain ownership changes that could limit the
Company's ability to utilize these NOLs and tax credits. Accordingly, the
Company's ability to utilize its NOLs and tax credit carryforwards to reduce
future taxable income and tax liabilities may be limited. As a result of the
1995 mergers with Triplex and Oncologix a change in control as defined by
federal income tax law occurred, causing the use of these carryforwards to be
limited and possibly eliminated. Additionally because U.S. tax laws limit the
time during which NOLs and the tax credit carryforwards may be applied against
future taxable income and tax liabilities, the Company may not be able to take
full advantage of its NOLs and tax credit carryforwards for federal income tax
purposes. The carryforwards will begin to expire in 2001 if not otherwise used.
A valuation allowance has been established to offset the Company's deferred tax
assets as the Company has had losses since inception. The Company has not made
any income tax payments since inception.
5. REVERSE STOCK SPLIT
At a special Meeting of Stockholders held on May 24, 1996, the stockholders
of the Company approved a one-for-two reverse split of the Common Stock (the
"Reverse Split"). The Reverse Split became effective with the filing of an
amendment to the Company's Certificate of Incorporation on July 1, 1996. The
accompanying financial statements have been restated to give effect to the
Reverse Split.
6. SUBSEQUENT EVENT
In April 1997, the Company signed a building lease from its current
landlord. Under this lease, the Company has committed to lease 30,000 square
feet for ten years at approximately $2.00 per square foot per month and pay
certain construction costs. The Company will occupy this lease space late in
1997 or early in 1998.
-8-
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
OVERVIEW
Since its inception in 1986, Aronex Pharmaceuticals, Inc. ("Aronex" or the
"Company") has primarily devoted its resources to fund research, drug discovery
and development. The Company has been unprofitable to date and expects to incur
substantial operating losses for the next several years as it expends its
resources for product research and development, preclinical and clinical testing
and regulatory compliance. The Company has sustained losses of approximately
$55.3 million through March 31, 1997. The Company has financed its research and
development activities and operations primarily through public and private
offerings of securities. The Company's operating results have fluctuated
significantly during each quarter, and the Company anticipates that such
fluctuations, largely attributable to varying commitments and expenditures for
clinical trials and research and development, will continue for the next several
years.
THREE MONTH PERIODS ENDED MARCH 31, 1996 AND 1997
Revenues from research and development grants and contracts were $286,000
and $543,000 for the three months ended March 31, 1997 and 1996, respectively.
The main reasons for the $257,000 decrease are as follows: a decrease of
$300,000 in revenues from Hoechst Marion Roussel, Inc. ("Hoechst") and a
decrease of $73,000 from Small Business Innovative Research ("SBIR") grants, as
the Hoechst agreement terminated at the end of 1996 and no SBIR grants have been
received for 1997. These decreases were partially offset by $150,000 in revenue
from the Company's license agreement with Boehringer Mannheim GmbH.
Interest income on cash, cash equivalents and investments was $592,000 and
$142,000 for the three months ended March 31, 1997 and 1996, respectively. The
increase of $450,000 was primarily due to an increase of funds available for
investment in 1997 resulting from cash received from the completion of a stock
offering in May 1996.
Research and development expenses were $3,485,000 in the first quarter of
1997 compared to $2,322,000 in the first quarter of 1996. The increase of
$1,163,000 was primarily due to an increase of $204,000 in pharmaceutical
development salaries and payroll costs, including cost relating to the hiring of
a Vice President of Pharmaceutical Development and Operations, an increase of
$522,000 in drug manufacturing costs relating mainly to Nyotran/(TM)/ and
Zintevir/(TM)/ and an increase of $249,000 in outside pharmacology studies
relating to Nyotran/(TM)/ and Atrogen/(TM)/.
General and administrative expenses were $456,000 in the first quarter of
1997 and $395,000 in the first quarter of 1996 due primarily to increased
salaries, including three new positions, and payroll costs.
Interest expense was $30,000 and $41,000 for the three months ended
March 31, 1997 and 1996, respectively. The $11,000 decrease in interest expense
resulted primarily from a decrease in the amount of laboratory equipment
obtained through leases and promissory notes payable.
Net loss for the first quarter of 1997 increased by $1,020,000 to
$2,073,000 compared to $3,093,000 for the first quarter of 1996, due mainly to
the increase in research and development expenses.
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, the Company's primary source of cash has been from
financing activities, which have consisted primarily of sales of equity
securities. The Company has raised an aggregate of approximately $75 million
from the sale of equity securities from its inception through March 31, 1997.
In July 1992, the Company raised net proceeds of approximately $10.7 million in
the initial public offering of its Common Stock. In September 1993, the Company
entered into a collaborative agreement with Genzyme relating to the development
and commercialization of Atrogen/(TM)/, in connection with which the Company
received net proceeds of approximately $4.5 million from the sale of Common
Stock to Genzyme. In November 1993 and May 1996, the Company raised net
proceeds of approximately $11.5 and $32.1 million, respectively, in public
offerings of Common Stock. From October 1995 through March 31, 1997, the
Company received aggregate net proceeds of approximately $6.5 million from the
exercise of certain warrants
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issued in its 1995 merger with Oncologix, Inc. From its inception until March
31, 1997, the Company also received an aggregate of $4.5 million cash from
collaborative arrangements and SBIR grants. In September 1995, the Company's
cash and securities held to maturity increased by approximately $6.7 million as
a result of its 1995 merger with Triplex Pharmaceutical Corporation.
The Company's primary use of cash to date has been in operating activities
to fund research and development, including preclinical studies and clinical
trials, and general and administrative expenses. Cash of $2.1 million and $2.9
million was used in operating activities during the first quarter of 1996 and
1997, respectively. The Company had cash, cash-equivalents and short-term and
long-term investments of $38.4 million as of March 31, 1997, consisting
primarily of cash and money market accounts, and United States government
securities and investment grade corporate bonds.
The Company has experienced negative cash flows from operations since its
inception and has funded its activities to date primarily from equity
financings. The Company has expended, and will continue to require, substantial
funds to continue research and development, including preclinical studies and
clinical trials of its products, and to commence sales and marketing efforts if
FDA and other regulatory approvals are obtained. The Company expects that its
existing capital resources will be sufficient to fund its capital requirements
through 1998. Thereafter, the Company will need to raise substantial additional
capital to fund its operations. The Company's capital requirements will depend
on many factors, including the problems, delays, expenses and complications
frequently encountered by development stage companies; the progress of the
Company's research, development and clinical trial programs; the extent and
terms of any future collaborative research, manufacturing, marketing or other
funding arrangements; the costs and timing of seeking regulatory approvals of
the Company's products; the Company's ability to obtain regulatory approvals;
the success of the Company's sales and marketing programs; costs of filing,
prosecuting and defending and enforcing any patent claims and other intellectual
property rights; and changes in economic, regulatory or competitive conditions
or the Company's planned business. Estimates about the adequacy of funding for
the Company's activities are based on certain assumptions, including the
assumption that testing and regulatory procedures relating to the Company's
products can be conducted at projected costs. There can be no assurance that
changes in the Company's research and development plans, acquisitions, or other
events will not result in accelerated or unexpected expenditures. To satisfy
its capital requirements, the Company may seek to raise additional funds in the
public or private capital markets. The Company's ability to raise additional
funds in the public or private markets will be adversely affected if the results
of its current or future clinical trials are not favorable. The Company may
seek additional funding through corporate collaborations and other financing
vehicles. There can be no assurance that any such funding will be available to
the Company on favorable terms or at all. If adequate funds are not available,
the Company may be required to curtail significantly one or more of its research
or development programs, or it may be required to obtain funds through
arrangements with future collaborative partners or others that may require the
Company to relinquish rights to some or all of its technologies or products. If
the Company is successful in obtaining additional financing, the terms of such
financing may have the effect of diluting or adversely affecting the holdings or
the rights of the holders of the Company's Common Stock.
-10-
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
+10.1 Amendment No. 3 to License and Development Agreement
between the Company and Genzyme Corporation.
10.2 Amendment No. 3 to Stock Purchase Agreement between the
Company and Genzyme Corporation.
10.3 Employment agreement dated December 5, 1996 between the
Company and Praveen Tyle, Ph.D.
10.4 Employment agreement dated February 25, 1997 between the
Company and David S. Gordon, M.D.
11.1 Statement regarding computation of per share earnings.
27.1 Financial data schedule.
(b) Reports on Form 8-K
None
+ Confidential treatment has been requested. The copy filed as an exhibit
omits the information subject to the confidentiality request.
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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.
ARONEX PHARMACEUTICALS, INC.
Dated: May 7, 1997 By: /s/ JAMES M. CHUBB
------------------------------
James M. Chubb, Ph.D.
President and Chief
Executive Officer
Dated: May 7, 1997 By: /s/ TERANCE A. MURNANE
------------------------------
Terance A. Murnane
Controller
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