FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
|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
Commission file number 1-12830
BioTime, Inc.
(Exact name of registrant as specified in its charter)
California 94-3127919
(State or other jurisdiction (IRS Employer
of incorporation or organization) Identification No.)
935 Pardee Street
Berkeley, California 94710
(Address of principal executive offices)
(510) 845-9535
(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 APPLICABLE ONLY TO CORPORATE
ISSUERS:
Indicate the number of shares outstanding of each of the issuer's classes
of common stock, as of the latest practicable date. 3,190,193 common shares, no
par value, as of February 13, 1997.
1
PART 1--FINANCIAL INFORMATION
Item 1. Financial Statements
BIOTIME, INC,
(A Development Stage Company)
CONDENSED BALANCE SHEETS
(Unaudited)
December 31, June 30,
ASSETS 1996 1996
-------------- ----------------
CURRENT ASSETS
Cash and cash equivalents $ 1,832,976 $ 2,443,121
Research and development supplies on hand (Note 2) 200,000 200,000
Prepaid expenses and other current assets 159,439 214,094
-------------- ----------------
Total current assets 2,192,415 2,857,215
EQUIPMENT, Net of accumulated depreciation of $118,466 and $98,219 81,313 101,559
OTHER ASSETS (Note 2) 44,044 9,700
-------------- ----------------
TOTAL ASSETS $ 2,317,772 $ 2,968,474
============== ================
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES--Accounts payable $ 321,912 $ 129,229
-------------- ----------------
COMMITMENTS
SHAREHOLDERS' EQUITY:
Preferred Shares, no par value, undesignated as to Series,
authorized 1,000,000 shares; none outstanding
Common Shares, no par value, authorized 5,000,000 shares; issued
and outstanding 2,831,084 and 2,756,521 11,464,033 10,834,575
Contributed Capital 93,972 93,972
Deficit accumulated during development stage (9,562,145) (8,089,302)
-------------- ----------------
Total shareholders' equity 1,995,860 2,839,245
-------------- ----------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 2,317,772 $ 2,968,474
============== ================
See notes to condensed financial statements.
2
BIOTIME, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Six Months Ended Period from Inception
December 31, December 31, (November 30, 1990)
1996 1995 1996 1995 to December 31, 1996
-------------- ------------ ------------- -------------- ----------------------
EXPENSES:
Research and development $ (485,659) $ (291,646) $ (917,825) $ (539,858) $ (5,690,853)
General and administrative (288,630) (206,631) (594,983) (340,004) (4,615,758)
-------------- ------------ ------------- -------------- ---------------
Total expenses (774,289) (498,277) (1,512,808) (879,862) (10,306,611)
-------------- ------------ ------------- -------------- ---------------
INCOME:
Interest 19,767 33,802 39,610 76,600 718,308
Other 35 1,080 355 2,460 50,989
-------------- ------------ ------------- -------------- ---------------
Total income 19,802 34,882 39,965 79,060 769,297
-------------- ------------ ------------- -------------- ---------------
NET LOSS $ (754,487) $ (463,395) $ (1,472,843) $ (800,802) $ (9,537,314)
============== ============ ============= ============== ===============
NET LOSS PER SHARE $ ( .27) $ ( .18) $ ( .53) $ ( .31) $ ( 4.73)
============== ============ ============= ============== ===============
NUMBER OF SHARES USED FOR
CALCULATION OF NET LOSS
PER SHARE 2,794,093 2,591,014 2,784,465 2,591,862 2,015,901
============== ============ ============= ============== ===============
See notes to condensed financial statements.
3
BIOTIME, INC.
(A Development Stage Company)
STATEMENTS OF SHAREHOLDERS' EQUITY
(Unaudited)
Series A Convertible Deficit
Preferred Shares Common Shares Accumulated
--------------------- ---------------------- During
Number of Number of Contributed Developmemt
Shares Amount Shares Amount Capital Stage
--------- --------- --------- ---------- ----------- ---------------
BALANCE, November 30, 1990
(date of inception)
NOVEMBER 1990
Common shares issued for cash 437,587 $ 263
DECEMBER 1990:
Common shares issued for
stock of a separate entity at fair value 350,070 137,400
Contributed equipment at appraised
value $ 16,425
Contributed cash 77,547
MAY 1991:
Common shares issued for cash
less offering costs 33,725 54,463
Common shares issued for stock
of a separate entity at fair value 33,340 60,000
JULY 1991:
Common shares issued for
services performed 10,000 18,000
AUGUST-DECEMBER 1991
Preferred shares issued for
cash less offering costs
of $125,700 120,000 474,300
MARCH 1992:
Common shares issued for
cash less offering costs of $1,015,873 724,500 4,780,127
Preferred shares converted
into common shares (120,000) (474,300) 120,000 474,300
Dividends declared and paid
on preferred shares (24,831)
MARCH 1994:
Common shares issued for cash less
offering costs of $865,826 935,200 3,927,074
NET LOSS SINCE INCEPTION (3,721,389)
--------- --------- --------- ----------- --------- -----------
BALANCE AT JUNE 30, 1994 $ -- 2,644,422 $ 9,451,627 $ 93,972 $(3,746,220)
See notes to financial statements. (Continued)
4
BIOTIME, INC.
(A Development Stage Company)
STATEMENTS OF SHAREHOLDERS' EQUITY
(Unaudited)
Series A Convertible Deficit
Preferred Shares Common Shares Accumulated
-------------------- ------------------------ During
Number of Number of Contributed Development
Shares Amount Shares Amount Capital Stage
--------- --------- ------------ ---------- ---------- ---------------
AUGUST 1994 - JUNE 1995
Common shares repurchased
with cash (84,600) (190,029)
NET LOSS (2,377,747)
--------- --------- --------- ----------- -------- --------------
BALANCE AT JUNE 30, 1995 -- $ -- 2,559,822 $ 9,261,598 $ 93,972 $ (6,123,967)
JULY - SEPTEMBER 1995
Common shares repurchased
with cash (6,200) (12,693)
Common shares warrants and options
granted for services 356,000
APRIL - JUNE 1996
Common shares issued for
cash (exercise of options and warrants) 165,507 1,162,370
Common shares issued for cash
(lapse of recission) 37,392 67,300
NET LOSS (1,965,335)
--------- --------- --------- ----------- --------- -------------
BALANCE AT JUNE 30, 1996 -- $ -- 2,756,521 $10,834,575 $ 93,972 $ (8,089,302)
JULY - DECEMBER 1996
Common shares issued for cash
(exercise of options and warrants) 74,563 524,458
Common shares warrants and options
granted for service (Note 2) 105,000
NET LOSS (1,472,843)
--------- --------- --------- ------------ --------- ------------
BALANCE AT DECEMBER 31, 1996 -- $ -- 2,831,084 $ 11,464,033 $ 93,972 $ (9,562,145)
========= ========= ========= ============ ========= ==============
See notes to financial statements. (Concluded)
5
BIOTIME, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended Period from Inception
December 31, (November 30, 1990) to
1996 1995 December 31, 1996
------------- ------------ ----------------------
OPERATING ACTIVITIES:
Net loss $(1,472,843) $ (800,802) $(9,537,314)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization 20,248 17,847 134,866
Cost of Services - options and warrants 140,549 326,481
Changes in operating assets and liabilities:
Research and development supplies on hand (125,000) (200,000)
Prepaid expenses and other current
assets (15,240) 24,421 (41,266)
Deposits (9,700)
Organizational costs (4,196)
Accounts payable 192,683 (222,762) 320,182
----------- ------------ -----------
Net cash used in operating activities (1,134,603) (1,106,296) (9,010,947)
----------- ------------ -----------
INVESTING ACTIVITIES:
Sale of investments 197,400
Purchase of short-term investments (9,946,203)
Redemption of short-term investments 9,934,000
Purchase of equipment and furniture (1,392) (183,353)
----------- ------------ -----------
Net cash used in investing activities -- (1,392) 1,844
----------- ------------ -----------
FINANCING ACTIVITIES:
Issuance of preferred shares for cash 600,000
Preferred shares placement costs (125,700)
Issuance of common shares for cash 10,710,926
Net proceeds from exercise of common share options
and warrants 524,458 1,686,828
Common shares placement costs (1,881,699)
Contributed capital - cash 77,547
Dividends paid on preferred shares (24,831)
Repurchase Common Shares (14,420) (200,992)
----------- ------------ -----------
Net cash provided by (used in) financing activities 524,458 (14,420) 10,842,079
----------- ------------ -----------
INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS (610,145) (1,122,108) 1,832,976
CASH: AND CASH EQUIVALENTS:
At beginning of period 2,443,121 3,440,896 --
----------- ------------ -----------
At end of period $ 1,832,976 $ 2,318,78 $ 1,832,976
=========== ============ ===========
See notes to condensed financial statements. (Continued)
6
BIOTIME, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Six Months Ended Period from Inception
December 31, (November 30, 1990) to
1996 1995 December 31, 1996
------------- ------------ ----------------------
NONCASH FINANCING AND
INVESTING ACTIVITIES:
$ 16,425
Receipt of contributed equipment
Issuance of common shares
in exchange for shares of
common stock of Cryomedical
Sciences, Inc. in a stock-for-stock
transaction $ 197,400
Granting of options and warrants for services 105,000 461,000
Accrued public offering costs 54,458
See notes to condensed financial statements. (Concluded)
7
BIOTIME, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
1. GENERAL AND DEVELOPMENT STAGE ENTERPRISE
General - BioTime, Inc. (the Company) was organized November 30, 1990
as a California corporation. The Company is a biomedical organization,
currently in the development stage, which is engaged in research and
development of synthetic plasma expanders, blood substitute solutions,
and organ preservation solutions, for use in surgery, trauma care,
organ transplant procedures, and other areas of medicine.
The interim condensed financial statements presented have been prepared
by BioTime, Inc. (the Company) without audit and, in the opinion of
management, reflect all adjustments necessary (consisting only of
normal recurring adjustments) to present fairly the financial position,
results of operations and cash flows at December 31, 1996 and for all
periods presented. The results of operations for any interim period are
not necessarily indicative of results for a full year.
The Balance Sheet as of June 30, 1996, has been derived from the
financial statements that have been audited by the Company's
independent public accountants. The condensed financial statements and
notes are presented as permitted by the Securities and Exchange
Commission and do not contain certain information included in the
annual financial statements and notes of the Company. It is suggested
that the accompanying condensed financial statements be read in
conjunction with the audited financial statements and the notes thereto
contained in the Company's Annual Report on Form 10-K for the fiscal
year ended June 30, 1996, filed with the Securities and Exchange
Commission.
The preparation of the Company's condensed financial statements in
conformity with generally accepted accounting principles necessarily
requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities in the condensed balance sheet dates and the
reported amounts of income and expenses for the periods presented.
Development Stage Enterprise - Since inception, the Company has been
engaged in research and development activities in connection with the
development of synthetic plasma expanders, blood substitute solutions
and organ preservation products. The Company has not had any
significant operating revenues and has incurred operating losses of
$9,537,314 from inception to December 31, 1996. The successful
completion of the Company's product development program and,
ultimately, achieving profitable operations is dependent upon future
events including maintaining adequate capital to finance its future
development activities, obtaining
8
regulatory approvals for the products it develops and achieving a level
of sales adequate to support the Company's cost structure.
The Company successfully completed two public offerings of its common
shares and, at December 31, 1996, had remaining cash and cash
equivalents of over $1,800,000. Management believes that additional
funds may be required for the successful completion of its product
development activities.
2. SHAREHOLDERS' EQUITY
The Board of Directors of the Company adopted the 1992 Stock Option
Plan (the "Plan") in September 1992, which was approved by the
shareholders at the 1992 Annual Meeting of Shareholders, on December 1,
1992. Under the Plan, as amended, the Company has reserved 400,000
Common Shares for issuance under options granted to eligible persons.
No options may be granted under the Plan more than ten years after the
date the Plan was adopted by the Board of Directors, and no options
granted under the Plan may be exercised after the expiration of ten
years from the date of grant.
At December 31, 1996, options for the purchase of 194,000 shares under
the Plan were held by employees, officers, directors, members of the
scientific advisory board and certain consultants. Such options are
exercisable at prices ranging from $1.99 to $18.81 beginning from one
to two years after the grant date and expire after five to ten years
from the grant date. Certain options require the achievement of
performance criteria. During the quarter ended December 31, 1996,
options to purchase a total of 10,000 common shares were issued to
consultants at an average option price of $18.81 per share. The
estimated fair value of the services totaled $20,000 and was recognized
in the period. At December 31, 1996, 184,000 options were exercisable
at prices ranging from $1.99 to $18.00. Options for 90,000 common
shares have been exercised as of December 31, 1996.
In September 1996, the Company entered into an agreement with an
individual to act as an advisor to the Company. In exchange for
services, as defined, to be rendered by the advisor through September
1999, the Company issued warrants, with five year terms, to purchase
40,000 common shares at a price of $18.75 per share. Warrants for
25,000 common shares vested and became exercisable and transferable
when issued; warrants for the remaining 15,000 common shares vest
ratably through September 1997 and become exercisable and transferable
as vesting occurs. The estimated value of the services to be performed
is $60,000 and that amount has been capitalized and is being amortized
over the term of the agreement.
During September 1995, the Company entered into an agreement with a
firm to act as its financial advisor. In exchange for financial
consulting services associated in part with a plan to secure additional
capital, the Company issued to the financial advisor warrants to
purchase 100,000 common shares at a price of $6 per share, and the
Company agreed to
9
issue additional warrants to purchase up to an additional 200,000
common shares at a price equal to the greater of (a) 150% of the
average market price of the common shares during the three months prior
to grant or (b) $6 per share. The additional warrants were to be issued
in equal quarterly installments over a two year period, beginning
October 15, 1995. The Company may terminate the financial advisory
agreement on 30 days notice, in which case the next warrant issuance
would be accelerated to the date on which notice of termination is
given, but no additional warrants would be issued. As of December 31,
1996, the total number of warrants to purchase Common Shares issued was
225,000; 150,000 of which aree exercisable at a price of $6 per share,
25,000 of which are exercisable at a price of $7.32 per share, 25,000
of which are exercisable at a price of $30.04 per share, and 25,000 of
which are exercisable at $29.33 per share. As of January 15, 1997,
warrants to purchase an additional 25,000 shares were issued, which are
exercisable at a price of $32.55 per share.
During the quarter ended December 31, 1996, the Company recognized
$50,136 in amortization expense for capitalized service costs related
to consulting agreements.
3. SUBSEQUENT EVENTS
On February 4, 1997, the Company completed a subscription rights
offering, raising $5,662,180 through the sale of 283,109 common shares.
In addition, from December 26, 1996 through February 10, 1997, the
Company received $772,271 through the exercise of certain underwriters'
warrants.
Item 2. Management's Discussion and Analysis of Financial Condition and Results
of Operations.
MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Overview
Since its inception in November 1990, the Company has been engaged
primarily in research and development activities. The Company has not yet
generated significant operating revenues, and as of December 31, 1996 the
Company had incurred a cumulative net loss of $9,537,314.
Most of the Company's research and development efforts have been
devoted to the development of the Company's first two blood volume replacement
products: Hextend(R) and PentaLyte.TM The Company is presently conducting a
Phase III clinical trial of Hextend(R) in human patients. The clinical trial
will involve approximately 150 patients and is designed to test whether the use
of Hextend(R) can improve patient outcomes by maintaining organ perfusion and
preventing the adverse effects of hypovolemia (loss of blood volume) during
surgery. The clinical trial began in October 1996 and
10
is being conducted at the Duke University Medical Center in Durham, North
Carolina and at Mt. Sinai School of Medicine in New York, New York. The trial is
proceeding in accordance with the Company's expectations. Additional studies are
being designed to assess the value of Hextend(R) in other surgical applications.
In order to commence clinical trials of new products and certain new
therapeutic uses of Hextend(R), it will be necessary for the Company to prepare
and file with the Food and Drug Administration ("FDA") an Investigational New
Drug Application ("IND") or an amendment to the present IND for Hextend(R). The
cost of preparing those IND filings and conducting those clinical trials is not
presently determinable. It may be necessary for the Company to obtain additional
financing in order to complete any clinical trials that may begin for its new
products or for additional uses of Hextend(R).
The Company plans to continue to provide funding for its laboratory
testing programs at selected medical schools and hospitals for the purpose of
developing additional uses of Hextend,(R) PentaLyteTM and other new products,
but the amount of research that will be conducted at those institutions will
depend upon the extent to which the Company can raise sufficient capital for
research in addition to the funding required for the clinical testing of new
products. If funding for collaborative research at medical schools and hospitals
is curtailed, the Company will have to rely on in-house research, using small
laboratory animals.
If the clinical trials of Hextend(R) are successful, the Company will
have to prepare a New Drug Application for FDA approval to manufacture and
market the new product. In order to complete a New Drug Application, the Company
will have to obtain the means of producing Hextend(R) in compliance with FDA
"good manufacturing practices."
To address its anticipated need for manufacturing and marketing
resources, the Company is negotiating with major pharmaceutical companies that,
based upon their current product lines and resources, will be able to
manufacture and market the Company's products if and when the necessary
regulatory approvals are obtained. The Company and the representatives of a
major pharmaceutical company are finalizing a manufacturing and marketing
agreement for certain Company products.
The acquisition of the Company's own production facilities and the
development of the Company's own marketing organization is also being considered
in the event that production and marketing arrangements cannot be made with
established pharmaceutical companies on terms that the Company deems
advantageous. Additional capital would be required in order for the Company to
acquire its own production facilities and marketing organization.
Because the Company's research and development expenses, clinical trial
expenses, and production and marketing expenses will be charged against earnings
for financial reporting purposes, management expects that losses from operations
will continue to be incurred for the foreseeable future.
11
Results of Operations
Revenues
From inception (November 30, 1990) through December 31, 1996, the
Company generated $769,297 of revenues, comprised of $50,989 from the sale of
products and services, and $718,308 in interest. For the three months ended
December 31, 1996, the Company generated total revenues of $19,802. During the
three months ended December 31, 1995, the Company had generated $34,882 of
revenues. For the six months ended December 31, 1996, the Company generated
$39,965 of revenues. For the six months ended December 31, 1995, the Company
generated $79,060 of revenues. Substantially all of the Company's revenues
during those periods was from interest income. The decrease in interest income
is attributable to the decrease in cash and cash equivalents from 1995 to 1996.
Limited test marketing of the Company's laboratory research equipment, through
advertisements in trade publications, has resulted in sales of a small number of
microcannulas. Although the Company may continue to test market its laboratory
research equipment, and to promote its ability to perform research services, the
Company's ability to generate substantial operating revenue depends upon its
success in developing and marketing its blood substitute and organ preservation
solutions and technology for medical use.
Operating Expenses
From inception (November 30, 1990) through December 31, 1996, the
Company incurred $5,690,853 of research and development expenses, including
salaries, supplies and other expense items. Research and development expenses
increased to $485,659 for the three months ended December 31, 1996, from
$291,646 for the three months ended December 31, 1995. Research and development
expenses also increased, to $917,825 for the six months ended December 31, 1996,
from $539,858 for the six months ended December 31, 1995. The increase in
research and development expenses is primarily attributable to preparation and
initiation of Phase III human clinical trials. It is expected that research and
development expenses will increase as the Company continues clinical testing of
Hextend(R) and commences clinical studies of other products.
From inception (November 30, 1990) through December 31, 1996, the
Company incurred $4,615,758 of general and administrative expenses. General and
administrative expenses increased to $288,630 for the three months ended
December 31, 1996 from $206,631 for the three months ended December 31, 1995.
General and administrative expenses also increased to $594,983 for the six
months ended December 31, 1996, from $340,004 for the six months ended December
31, 1995. The increase is primarily attributable to increased personnel costs
and to an amortization expense of $50,136 associated with agreements the Company
entered into with certain financial advisors and consultants in exchange for
warrants to purchase the Company's common shares (See Note 2 to the accompanying
financial statements).
12
Liquidity and Capital Resources
Because of the developmental nature of the Company's business, it is
highly unlikely that in the foreseeable future the Company will be able to
generate internally the funds necessary to carry on its planned operations.
Since inception, the Company has financed its operations through the sale of
equity securities. On February 4, 1997, the Company completed a subscription
rights offering, raising $5,662,180 through the sale of 283,109 common shares.
In addition, from December 26, 1996 through February 10, 1997, the Company
received $772,271 through the exercise of certain underwriters' warrants.
The future availability and terms of equity and debt financings and
collaborative arrangements with industry partners cannot be predicted. The
unavailability or inadequacy of financing to meet future capital needs could
force the Company to modify, curtail, delay or suspend some or all aspects of
its planned operations.
13
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.
BIOTIME, INC.
Date: February 12, 1997 --------------------------------------------
Paul E. Segall, Ph.D.
Chief Executive Officer
Date: February 12, 1997 --------------------------------------------
Victoria Bellport
Chief Financial Officer
14
5
3-MOS
JUN-30-1997
OCT-01-1996
DEC-31-1996
1,832,976
0
0
0
0
2,192,415
81,313
118,466
2,317,772
321,912
0
0
0
11,464,033
0
2,317,772
0
0
0
0
(774,289)
0
0
(754,487)
0
0
0
0
0
(754,487)
(0.27)
0
