1
FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
(X) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES AND
EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 1996
OR
( ) TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND
EXCHANGE ACT OF 1934
For the transition period from to
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Commission file number 0-26872
GELTEX PHARMACEUTICALS, INC.
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(Exact name of registrant as specified in its charter)
Delaware 04-3136767
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(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
303 Bear Hill Road
Waltham, Massachusetts 02154
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(Address of principal executive offices) (Zip Code)
617-290-5888
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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
--- ---
The number of shares outstanding of each of the issuer's classes of common stock
as of the latest practicable date:
Class Outstanding at June 30, 1996
- ---------------------------- ----------------------------
Common Stock, $.01 par value 13,498,138
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THIS IS PAGE 1 OF 14 PAGES. THE EXHIBIT INDEX IS ON PAGE 13.
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GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
TABLE OF CONTENTS
Page No.
PART I FINANCIAL INFORMATION
ITEM 1 Financial Statements
Condensed Balance Sheets as of June 30, 1996
and December 31, 1995.................................. 3
Condensed Statements of Operations for the three
months ended June 30, 1996 and 1995.................... 4
Condensed Statements of Operations for the six
months ended June 30, 1996 and 1995, and for the
period November 15, 1991 (date
of inception) through June 30, 1996.................... 5
Condensed Statements of Cash Flows for the six
months ended June 30, 1996 and 1995, and for the
period November 15, 1991 (date
of inception) through June 30, 1996.................... 6
Notes to Condensed Financial Statements................ 7
ITEM 2 Management's Discussion and Analysis of
Financial Condition and Results of Operations.......... 8
PART II OTHER INFORMATION
ITEM 4 Submission of Matters to a Vote of Security Holders....10
ITEM 6 Exhibits and Reports on Form 8-K.......................11
SIGNATURE.................................................................. 12
EXHIBIT INDEX.............................................................. 13
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED BALANCE SHEETS
(UNAUDITED)
June 30, December 31,
1996 1995
--------------- -------------
ASSETS
Current assets:
Cash and cash equivalents........................................ $ 24,887,634 $ 12,179,988
Marketable securities............................................ 61,844,609 20,995,110
Prepaid expenses and other current assets........................ 1,365,536 572,864
--------------- -------------
Total current assets............................................... 88,097,779 33,747,962
Long-term receivables.............................................. 20,000 20,000
Property and equipment, net........................................ 1,996,651 1,948,788
Intangible assets, net............................................. 309,249 276,527
--------------- --------------
$ 90,423,679 $35,993,277
=============== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and accrued expenses.............................. $ 1,477,315 $ 1,388,416
Current portion of long-term obligations........................... 557,339 535,293
--------------- --------------
Total current liabilities............................................ 2,034,654 1,923,709
Long-term obligations, less current portion.......................... 251,888 419,569
Stockholders' equity:
Undesignated Preferred Stock, $.01 par value; 5,000,000 shares
authorized, none issued or outstanding....................... -- --
Common Stock, $.01 par value, 50,000,000, and 20,000,000
shares authorized; 13,498,138 and 10,535,065 shares issued
and outstanding at June 30, 1996 and December 31, 1995,
respectively................................................. 134,981 105,350
Additional paid-in capital......................................... 105,229,485 44,000,986
Deferred compensation.............................................. (50,976) (55,825)
Deficit accumulated during the development stage................... (17,154,184) (10,482,102)
Unrealized gain (loss) on available-for-sale securities............ (22,169) 81,590
---------------- --------------
Total stockholders' equity........................................... 88,137,137 33,649,999
--------------- --------------
$ 90,423,679 $ 35,993,277
=============== ==============
The accompanying notes are an integral part of the financial statements.
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GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
Three Months
Ended June 30,
---------------------------------
1996 1995
-------------- --------------
Revenue:
License fee and research revenue................... $ 47,544 $ --
Research grant..................................... 63,767 57,372
-------------- --------------
Total revenue......................................... 111,311 57,372
Costs and expenses:
Research and development........................... 4,229,261 1,595,428
General and administrative......................... 714,696 394,952
-------------- --------------
Total costs and expenses.............................. 4,943,957 1,990,380
-------------- --------------
Loss from operations.................................. (4,832,646) (1,933,008)
Interest income....................................... 813,237 156,675
Interest expense...................................... (20,238) (23,198)
--------------- ---------------
Net loss.............................................. $ (4,039,647) $ (1,799,531)
=============== ===============
Net loss per share ................................... $ (.32) $ (.22)
=============== ===============
Shares used in computing
net loss per share ................................ 12,457,000 8,018,000
The accompanying notes are an integral part of the financial statements.
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GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Period
November 15,
Six Months 1991 (date
Ended June 30, of inception)
--------------------------------- through
1996 1995 June 30 , 1996
-------------- -------------- -------------
Revenue:
License fee and research revenue................... $ 47,544 $ -- $ 3,797,544
Research grant..................................... 213,589 57,372 370,999
-------------- -------------- -------------
Total revenue......................................... 261,133 57,372 4,168,543
Costs and expenses:
Research and development........................... 6,792,471 2,557,904 18,042,913
General and administrative......................... 1,283,229 786,868 5,336,284
-------------- -------------- --------------
Total costs and expenses.............................. 8,075,700 3,344,772 23,379,197
-------------- -------------- --------------
Loss from operations.................................. (7,814,567) (3,287,400) (19,210,654)
Interest income....................................... 1,184,874 337,000 2,249,774
Interest expense...................................... (42,389) (50,795) (193,304)
-------------- -------------- --------------
Net loss.............................................. $ (6,672,082) $ (3,001,195) $ (17,154,184)
============== ============== ==============
Net loss per share ................................... $ (.58) $ (.38)
================= =================
Shares used in computing
net loss per share ................................ 11,516,000 8,003,000
The accompanying notes are an integral part of the financial statements.
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GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Period
November 15,
Six Months 1991 (date
Ended June 30, of inception)
--------------------------------- through
1996 1995 June 30 , 1996
-------------- -------------- --------------
OPERATING ACTIVITIES
Net loss.................................................. $ (6,672,082) $ (3,001,195) $ (17,154,184)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization ......................... 325,037 173,421 1,245,506
Issuance of Common Stock as compensation .............. -- -- 5,000
Changes in operating assets and liabilities:
Prepaid expenses and other current assets ........... (792,672) (59,008) (1,365,536)
Long-term receivables -- -- (20,000)
Accounts payable and accrued expenses ............... 88,899 (250,367) 1,477,315
-------------- -------------- --------------
Net cash used in operating activities..................... (7,050,818) (3,137,149) (15,811,899)
INVESTING ACTIVITIES
Purchase of marketable securities......................... (56,850,213) (5,780,882) (89,063,373)
Proceeds from sale and maturities of
marketable securities 15,896,955 3,910,306 27,196,595
Purchase of intangible assets............................. (111,119) (76,076) (520,877)
Purchase of property and equipment, net................... (289,655) (131,364) (2,009,918)
-------------- -------------- --------------
Net cash used in investing activities..................... (41,354,032) (2,078,016) (64,397,573)
FINANCING ACTIVITIES
Sale of Common Stock and warrants, net of
issuance costs......................................... 61,200,999 2,902 87,556,769
Proceeds from employee stock purchase plan................ 57,132 -- 57,132
Sale of Preferred Stock, net of issuance costs............ -- -- 17,480,688
Proceeds from notes payable............................... -- 112,659 735,000
Payments on notes payable and capital lease obligations... (145,635) (201,809) (732,483)
-------------- -------------- --------------
Net cash provided by (used in) financing activities....... 61,112,496 (86,248) 105,097,106
-------------- -------------- --------------
Increase (decrease) in cash and cash equivalents.......... 12,707,646 (5,301,413) 24,887,634
Cash and cash equivalents at beginning of period.......... 12,179,988 6,560,110 --
-------------- -------------- --------------
Cash and cash equivalents at end of period................ $ 24,887,634 $ 1,258,697 $ 24,887,634
============== ============== ==============
Schedule of noncash investing and financing activities:
Purchase of intangible assets for Common Stock....... $ 2,700
Issuance of Preferred Stock to cancel notes
payable............................................ $ 185,000
Property and equipment acquired under capital
leases............................................. $ 992,000
The accompanying notes are an integral part of the financial statements.
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GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited condensed financial statements for the three
and six months ended June 30, 1996 and 1995 and for the period November 15, 1991
(date of inception) through June 30, 1996 have been prepared in accordance with
generally accepted accounting principles for interim financial information and
with the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all the information and footnotes required by
generally accepted accounting principles for complete financial statements. In
the opinion of management, the accompanying condensed financial statements
include all adjustments, consisting of normal recurring accruals, necessary for
a fair presentation of the financial condition, results of operations and cash
flows for the periods presented. The results of operations for the interim
period ended June 30, 1996 are not necessarily indicative of the results to be
expected for the year ended December 31, 1996.
These financial statements should be read in conjunction with the
audited financial statements and notes thereto for the fiscal year ended
December 31, 1995 included in the Company's Annual Report on Form 10-K (File
Number 0-26872) as filed with the Securities and Exchange Commission.
2. NET LOSS PER SHARE
Net loss per share is computed using the weighted average number of
outstanding shares of Common Stock and Common Stock equivalents, assuming
conversion of Series A, B and C Convertible Preferred Stock into common shares
as of their original date of issuance, which occurred upon the completion of the
Company's initial public offering in November 1995, and the exercise of stock
options and warrants (using the treasury stock method). Common Stock equivalent
shares are excluded from the computation if their effect is anti-dilutive;
however, pursuant to the requirements of the Securities and Exchange Commission,
common equivalent shares relating to stock options (using the treasury stock
method and the initial public offering price) issued during the twelve months
prior to the initial public offering are included for all periods presented
prior to June 30, 1995 whether or not they are anti-dilutive.
3. ADOPTION OF NEW ACCOUNTING PRONOUNCEMENTS
ACCOUNTING FOR IMPAIRMENT OF LONG-LIVED ASSETS
On January 1, 1996, the Company adopted Financial Accounting Standards
Board Standard No. 121, "Accounting for the Impairment of Long-Lived Assets and
for Long-Lived Assets to be Disposed Of," which established criteria for the
recognition and measurement of impairment loss associated with long-lived
assets. Adoption of this standard had no impact on the Company's financial
position or results of operations.
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GELTEX PHARMACEUTICALS, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
4. ADOPTION OF NEW ACCOUNTING PRONOUNCEMENTS -- (CONTINUED)
STOCK BASED COMPENSATION
The Company has elected to follow Accounting Principles Board Opinion
No. 25, "Accounting for Stock Issued to Employees" (APB 25) and related
Interpretations in accounting for its stock-based compensation plans, rather
than the alternative fair value accounting provided for under Financial
Accounting Standards Board Statement No.123, "Accounting for Stock-Based
Compensation." Under APB 25, for those options granted in which the exercise
price equals or exceeds the market price of the underlying stock on the date of
grant, no compensation expense is recognized.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 1996 AND 1995
The Company earned revenues of $111,000 during the three months ended
June 30, 1996 compared with $57,000 earned during the three months ended June
30, 1995. These revenues were earned under the Company's $2.0 million grant from
the United States Department of Commerce's Advanced Technology Program and under
one of the Company's collaborative agreements.
The Company's total operating expenses for the three months ended June
30, 1996 were $4.9 million, as compared to $2.0 million during the three months
ended June 30, 1995. Research and development expenses increased to $4.2 million
for the three months ended June 30, 1996 from $1.6 million for the three months
ended June 30, 1995 due primarily to increased third party expenses associated
with the development of CholestaGel(R) and RenaGel(R) (including production of
clinical trial material, toxicology studies, clinical trial expenses and process
development expense) and increases in research and development personnel costs.
General and administrative expenses increased to $715,000 for the three months
ended June 30, 1996 from $395,000 for the three months ended June 30, 1995 due
primarily to increased business development expenses and increased
administrative personnel.
Interest income increased to $813,000 for the three months ended June
30, 1996 from $157,000 for the three months ended June 30, 1995 due primarily to
increases in cash balances attributable to the Company's sale of equity
securities through its initial public offering in November 1995 and a secondary
public offering in May 1996.
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SIX MONTHS ENDED JUNE 30, 1996 AND 1995
The Company earned revenues of $261,000 during the six months ended
June 30, 1996, as compared to $57,000 during the six months ended June 30, 1995.
These revenues were earned under the Company's $2.0 million grant from the
United States Department of Commerce's Advanced Technology Program and under one
of the Company's collaborative agreements.
The Company's total operating expenses for the six months ended June
30, 1996 were $8.1 million as compared to $3.3 million during the six months
ended June 30, 1995. Research and development expenses increased to $6.8 million
for the six months ended June 30, 1996 from $2.6 million for the six months
ended June 30, 1995 due primarily to increased third party expenses associated
with the development of CholestaGel(R) and RenaGel(R) (including production of
clinical trial material, toxicology studies, clinical trial expenses and process
development expenses) and increases in research and development personnel costs.
General and Administrative expenses increased to $1.3 million for the six months
ended June 30, 1996 from $787,000 for the six months ended June 30, 1995 due
primarily to increased business development expenses and increased
administrative personnel costs.
Interest income increased to $1.2 million for the six months ended June
30, 1996 from $337,000 for the six months ended June 30, 1995 due primarily to
the Company's sale of equity securities through its initial public offering in
November 1995 and a secondary public offering in May 1996.
LIQUIDITY AND CAPITAL RESOURCES
As of June 30, 1996, the Company had $86.7 million in cash, cash
equivalents and marketable securities.
The Company leases its administrative and research and development
facilities under a long-term operating lease expiring in 2004 and certain
leasehold improvements and equipment under capital leases expiring in 1997. In
October 1995, the Company obtained a line of credit with a bank for $250,000 for
the purchase of new equipment, which bears interest at the prime rate and is
available through June 30, 1996. As of June 30, 1996, $118,000 was outstanding
on this line. This line, which is secured by equipment, requires the Company to
maintain minimum cash balances and a minimum net worth and to repay any
outstanding amounts in 33 equal monthly installments. The Company has no
material commitments for capital expenditures as of June 30, 1996.
The Company successfully completed a public offering of 2,875,000
shares of its Common Stock in May 1996. The Company believes that the cash and
marketable securities balance at June 30, 1996, which includes the net proceeds
from the aforementioned offering, and the interest income thereon, should be
sufficient to fund its operating expenses and capital requirements as currently
planned through 1998. However, the Company's cash requirements may vary
materially from those now planned because of results of research and
development, results of clinical trials, new relationships with strategic
partners, changes in the focus and direction of the Company's research and
development programs, competitive and technological advances, the FDA regulatory
process and other factors. Adequate funds for these purposes, whether through
additional sales of securities or collaborative or other arrangements with
corporate partners or from other sources, may not be available when needed or on
terms acceptable to the Company. Insufficient funds may require the Company to
delay, scale back or eliminate certain of its research and product development
programs or to license third parties to commercialize products or technologies
under terms that the Company might otherwise find unacceptable.
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The discussion contained in this Item as well as elsewhere in this
Quarterly Report on Form 10-Q may contain forward looking statements based on
the current expectations of the Company's management. There are certain factors
that could cause results to differ from those anticipated by the statements made
herein, including, but not limited to: technical risks associated with the
development of new products; continued progress of clinical trials of the
Company's pharmaceuticals; the continued availability of raw material for the
Company's pharmaceuticals; the Company's ability to continue to establish
collaborative arrangements with third parties; and the competitive environment
of the biotechnology and pharmaceutical industries. Readers are cautioned not to
place undue reliance on these forward looking statements which speak only as of
the date hereof.
PART II. OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Company's 1996 Annual Meeting of Stockholders was held on May 20,
1996. The following is a description of the ten matters submitted to a vote of
stockholders at such meeting and the results of voting.
(i) At the meeting eight directors were elected to the Company's Board of
Directors as follows:
Number of Shares Number of Votes
Voted For Withheld
---------------- ---------------
Robert Carpenter 7,705,528 23,850
Barbara A. Piette 7,705,528 23,850
Ernest Parizeau 7,705,528 23,850
Mark Skaletsky 7,705,528 23,850
James Tananbaum 7,676,528 52,850
Henri Termeer 7,631,728 97,650
Jesse Treu 7,705,528 23,850
George Whitesides 7,705,528 23,850
There were no broker non-votes with respect to this matter.
(ii) The stockholders also approved a proposal to amend the Company's
Restated Certificate of Incorporation to increase the number of authorized
shares of the Company's Common Stock, $.01 par value per share ("Common Stock"),
from 20,000,000 to 50,000,000, as follows:
Number of Shares Voted For: 7,677,028; Against: 46,650; Abstaining:
5,700; Broker Non-Votes: 0.
(iii) The stockholders also approved a proposal to amend the Company's
Restated Certificate of Incorporation to divide the Company's Board of
Directors into three classes, as follows:
Number of Shares Voted For: 6,487,433; Against: 106,425; Abstaining:
5,700; Broker Non-Votes: 1,129,820.
(iv) The stockholders also approved a proposal to amend the Company's
Restated Certificate of Incorporation to require the affirmative vote of at
least 66 2/3% of the Company's outstanding capital stock entitled to vote
thereon to authorize certain corporate transactions, as follows:
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Number of Shares Voted For: 6,335,533; Against: 258,525; Abstaining:
5,500; Broker Non-Votes: 1,129,820.
(v) The stockholders also approved a proposal to amend the Company's
Restated Certificate of Incorporation to prohibit stockholder action by written
consent, as follows:
Number of Shares Voted For: 8,434,533; Against: 112,575; Abstaining:
52,450; Broker Non-Votes: 1,129,820.
(vi) The stockholders also approved amendments to the Company's 1992 Equity
Incentive Plan (the "Equity Plan") to increase the aggregate number of shares
of Common Stock for which awards may be granted under such plan from 1,325,000
shares to 1,725,000 shares and to limit the number of shares of Common Stock
subject to awards that may be granted under the Equity Plan to any individual
in any fiscal year to 250,000 shares, as follows:
Number of Shares Voted For: 6,529,247; Against: 82,500; Abstaining:
5,450; Broker Non-Votes: 1,112,181.
(vii) The stockholders also approved the Company's 1995 Director Stock Option
Plan, as follows:
Number of Shares Voted For: 6,602,652; Against: 12,725; Abstaining:
1,820; Broker Non-Votes: 1,112,181.
(viii) The stockholders also approved the Company's 1995 Employee Stock
Purchase Plan, as follows:
Number of Shares Voted For: 6,610,977; Against: 5,200; Abstaining:
1,020; Broker Non-Votes: 1,112,181.
(ix) The stockholders also approved the form of indemnification agreement
for execution between the Company and its directors and officers, as follows:
Number of Shares Voted For: 7,720,878; Against: 7,150; Abstaining:
1,350; Broker Non-Votes; 0.
(x) The stockholders also approved the appointment of Ernst & Young LLP as
independent accountants for the fiscal year ending December 31, 1996, as
follows:
Number of Shares Voted For: 7,728,028; Against: 250; Abstaining: 1,100;
Broker Non-Votes; 0.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
See the Exhibit Index on page 13 hereto.
(b) Reports on Form 8-K.
During the three months ended June 30, 1996 the Company filed a Current
Report on Form 8-K dated June 26, 1996 reporting that the Company had (i)
received notice from Ono Pharmaceuticals Co., Ltd., that it had terminated its
agreement to develop CholestaGel(R) non-absorbed cholesterol reducer for sale in
Japan, China, Korea and Taiwan and (ii) initiated a multi-center dose
refinement, Phase IIb clinical trial with CholestaGel in the United States.
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GELTEX PHARMACEUTICALS, INC.
FORM 10-Q
JUNE 30, 1996
SIGNATURE
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.
GELTEX PHARMACEUTICALS, INC.
DATE: August 12, 1996 BY: /s/ Mark Skaletsky
-------------------------------
Mark Skaletsky
Duly Authorized Officer and
Principal Financial Officer
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EXHIBIT INDEX
Exhibit Number Description Page
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11.1 Statement re: computation of per share earnings 14
27 Financial Data Schedule
(filed with electronic submission only)
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