1
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON OCTOBER 1, 1998
REGISTRATION NO. 333-47725
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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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AMENDMENT NO. 5
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
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ANTHRA PHARMACEUTICALS, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
DELAWARE 5122 22-3007972
(STATE OF INCORPORATION) (PRIMARY STANDARD INDUSTRIAL (I.R.S. EMPLOYER
CLASSIFICATION CODE NUMBER) IDENTIFICATION NO.)
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103 CARNEGIE CENTER, SUITE 102
PRINCETON, NEW JERSEY 08540
(609) 514-1060
(ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE, OF
REGISTRANT'S PRINCIPAL EXECUTIVE OFFICES)
MICHAEL C. WALKER
PRESIDENT AND CHIEF EXECUTIVE OFFICER
ANTHRA PHARMACEUTICALS, INC.
103 CARNEGIE CENTER, SUITE 102
PRINCETON, NEW JERSEY 08540
(609) 514-1060
(NAME, ADDRESS, INCLUDING ZIP CODE, AND TELEPHONE NUMBER, INCLUDING AREA CODE,
OF AGENT FOR SERVICE)
------------------------
COPIES TO:
JOSEPH W. BARTLETT, ESQ. STANLEY R. GOLDSTEIN, ESQ.
MORRISON & FOERSTER LLP GOLDSTEIN & DIGIOIA LLP
1290 AVENUE OF THE AMERICAS 369 LEXINGTON AVENUE,
NEW YORK, NEW YORK 10104-0012 18TH FLOOR
(212) 468-8000 NEW YORK, NEW YORK 10017
(212) 599-3322
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APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the effective date of the Registration Statement.
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If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, as amended (the "Securities Act"), check the following box. [X]
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, check the following box and
list the Securities Act registration statement number of the earlier effective
registration statement for the same offering. [ ]
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. [ ]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
check the following box. [ ]
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THE REGISTRANT HEREBY AMENDS THE REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THE REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF
THE SECURITIES ACT OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON
SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY
DETERMINE.
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Registration No. 333-47725
ANTHRA PHARMACEUTICALS, INC.
SUPPLEMENT DATED OCTOBER 1, 1998 TO PRELIMINARY PROSPECTUS DATED SEPTEMBER 25,
1998
This Supplement is part of, and should be read in conjunction with, the
Preliminary Prospectus dated September 25, 1998 (the "Prospectus"). Defined
terms used herein (unless otherwise defined) have the meanings set forth in the
Prospectus.
VALSTAR(TM)/MEDEVA AGREEMENT
For purposes of updating the information described in the Prospectus in the
sections entitled "Prospectus Summary -- The Company," "Risk Factors,"
"Management's Discussion and Analysis of Financial Condition and Results of
Operations," "Business -- General," and "Business -- Products and Markets," on
September 28, 1998, Anthra received notice from the FDA of the FDA's approval of
the Company's NDA for Valstar(TM) for intravesical therapy of BCG-refractory
carcinoma in-situ of the bladder for patients for whom immediate cystectomy
would be associated with unacceptable morbidity or mortality (the "FDA Approved
Indication"). For purposes of updating the information described in the
Prospectus in the sections entitled "Risk Factors," "Management's Discussion and
Analysis of Financial Condition and Results of Operations,"
"Business -- Products and Markets," and "Consolidated Financial Statements," due
to Anthra's receipt of the FDA's approval of the FDA Approved Indication, (i)
Medeva no longer has the right to require the Company, under the circumstances
set forth in the Medeva Agreement, to issue such number of shares of Common
Stock equal to 20% of the issued and outstanding voting equity securities of the
Company outstanding at the time of the exercise of such right, (ii) Medeva's
initial $8 million payment to Anthra under the Medeva Agreement has been
reclassified from a contingent stock obligation; substantially all of the $8
million has been recognized as revenue with the balance recorded as deferred
revenue, and (iii) Anthra is entitled to receive from Medeva additional
milestone payments and license fees in the aggregate amount of $5.5 million.
BONEFOS AGREEMENTS
For purposes of updating the information described in the Prospectus in the
sections entitled "Prospectus Summary -- The Company," "Risk Factors,"
"Management's Discussion and Analysis of Financial Condition and Results of
Operations," "Business -- General," "Business -- Products and Markets," and
"Consolidated Financial Statements," on September 30, 1998, the Company entered
into the Bonefos Agreements by exercising its option under the Bonefos Option
Agreement by making the $800,000 non-refundable payment to Leiras Oy required
under the Bonefos Option Agreement. In connection with the exercise of such
option, the Bonefos Agreements were amended, including an amendment extending
the deadline for the Company to make a $2.5 million payment to Leiras Oy for
certain rights with respect to Bonefos(R) from December 31, 1998 to January 31,
1999.
UNDERWRITING
For purposes of updating the information described in the Prospectus in the
section entitled "Underwriting," the Underwriter has informed the Company that
sales to discretionary accounts by the Underwriter will not exceed 5% of the
securities offered in the Offering.
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INFORMATION CONTAINED HEREIN IS SUBJECT TO COMPLETION OR AMENDMENT. A
REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY
OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES
EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES
IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR
TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE.
SUBJECT TO COMPLETION DATED SEPTEMBER 25, 1998
PRELIMINARY PROSPECTUS
2,000,000 UNITS
[ANTHRA PHARMACEUTICALS, INC. LOGO]
EACH UNIT CONSISTING OF ONE SHARE OF COMMON STOCK
AND ONE CLASS A REDEEMABLE COMMON STOCK PURCHASE WARRANT
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Anthra Pharmaceuticals, Inc. (together with its wholly owned subsidiary,
"Anthra" or the "Company") is offering 2,000,000 units ("Units"), each Unit
consisting of one share of the Company's common stock, par value $.01 per share
(the "Common Stock"), and one Class A redeemable common stock purchase warrant
to purchase one share of Common Stock (the "Warrants"). The Units will separate,
and the Common Stock and Warrants that make up the Units will trade only as
separate securities, one year after the date of this Prospectus or on such
earlier date as determined by the Underwriter (the "Separation Date"). Each
Warrant entitles the holder to purchase one share of Common Stock at a price of
$6.00 per share. The Warrants are exercisable at any time beginning on the
Separation Date unless previously redeemed, until the fifth anniversary of this
Prospectus, subject to certain conditions. The Company may redeem the Warrants,
in whole or in part, on or after the date 15 months from the date of this
Prospectus upon at least thirty days' prior written notice to the registered
holders thereof, at a price of $.10 per Warrant, provided that (i) the last
sales price of the Common Stock as reported on the American Stock Exchange has
been at least $9.00 for at least 20 consecutive trading days ending within ten
days of the date of the notice of redemption and (ii) there is a current
registration statement covering the resale of the underlying shares of Common
Stock. Prior to this offering (the "Offering"), there has been no public market
for the Units, the Common Stock or the Warrants of the Company. It is currently
estimated that the initial public offering price will be $5.00 per Unit. See
"Underwriting" for a discussion of the factors to be considered in determining
the initial public offering price.
The Company intends to apply for listing of the Units, the Common Stock and
the Warrants on the American Stock Exchange under the proposed symbols of "APU,"
"APX" and "APW," respectively.
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THIS OFFERING INVOLVES A HIGH DEGREE OF RISK. SEE "RISK FACTORS" BEGINNING ON
PAGE 8.
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THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE SECURITIES AND
EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION NOR HAS THE SECURITIES
AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION PASSED UPON THE
ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
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PRICE TO UNDERWRITING DISCOUNTS PROCEEDS TO
PUBLIC AND COMMISSIONS(1) COMPANY(2)
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Per Unit...................................... $ $ $
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Total(3)...................................... $ $ $
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(1) Does not reflect additional compensation payable to Janssen/Meyers
Associates, L.P., as Underwriter (the "Underwriter"), in the form of (i) a
non-accountable expense allowance equal to 3% of the gross proceeds of the
Offering, (ii) any value attributable to the Underwriter's warrants to
purchase 200,000 Units (the "Underwriter's Warrant"), exercisable over a
period of four years, commencing one year from the date hereof, at a per
Unit exercise price equal to $7.00 (140% of the initial public offering
price); and (iii) a three year consulting agreement at an overall fee of
approximately $100,000 payable at the closing of the Offering. In addition,
see "Underwriting" for information concerning indemnification arrangements
with the Underwriter and other compensation payable to the Underwriter.
(2) Before deducting estimated expenses of $ payable by the Company,
excluding the non-accountable expense allowance payable to the Underwriter.
(3) The Company has granted to the Underwriter a 45-day option to purchase up to
300,000 additional Units on the same terms and conditions as the securities
offered hereby solely to cover over-allotments, if any. If such option is
exercised in full, the total Price to Public, Underwriting Discounts and
Commissions, and Proceeds to Company, will be $ , $ , and
$ , respectively. See "Underwriting."
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The securities are being offered by the Underwriter, subject to prior sale,
when, as and if delivered to and accepted by the Underwriter and subject to
approval of certain legal matters by its counsel and subject to certain other
conditions. The Underwriter reserves the right to withdraw, cancel or modify the
Offering and to reject any order in whole or in part. It is expected that
delivery of the securities offered hereby will be made against payment on or
about , 1998, at the offices of Janssen/Meyers Associates,
L.P., 17 State Street, New York, NY 10004.
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JANSSEN/MEYERS ASSOCIATES, L.P.
The date of this Prospectus is , 1998.
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[GRAPHIC DEPICTING DEVELOPMENT OF VALSTAR(TM) AND BONEFOS(R)]
IN CONNECTION WITH THIS OFFERING, THE UNDERWRITER MAY OVER-ALLOT OR EFFECT
TRANSACTIONS WHICH STABILIZE OR MAINTAIN THE MARKET PRICE OF THE UNITS, THE
COMMON STOCK OR THE WARRANTS OF THE COMPANY AT A LEVEL ABOVE THAT WHICH MIGHT
OTHERWISE PREVAIL IN THE OPEN MARKET. SUCH TRANSACTIONS MAY BE EFFECTED ON THE
AMERICAN STOCK EXCHANGE OR OTHERWISE. SUCH STABILIZING, IF COMMENCED, MAY BE
DISCONTINUED AT ANY TIME.
MOST OF THE COMPANY'S DRUG PRODUCT CANDIDATES ARE CURRENTLY UNDERGOING
CLINICAL TRIALS. TO DATE, THE COMPANY HAS NOT COMPLETED THE DEVELOPMENT, OR
GENERATED REVENUES FROM SALES, OF ANY PRODUCTS, AND UNITED STATES FOOD AND DRUG
ADMINISTRATION AND OTHER REGULATORY APPROVALS WILL BE REQUIRED BEFORE SUCH
PRODUCTS CAN BECOME COMMERCIALLY AVAILABLE.
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PROSPECTUS SUMMARY
The following summary is qualified in its entirety by the more detailed
information appearing elsewhere in this Prospectus, including "Risk Factors" and
the Consolidated Financial Statements and Notes thereto. Unless otherwise
indicated, all information in this Prospectus assumes (i) no exercise of the
Underwriter's over-allotment option, and (ii) that the Company is successful in
obtaining from certain stockholders agreements to convert and the resultant
conversion of an aggregate of 3,789,683 shares of the Company's Series A, B, C
and D Convertible Preferred Stock (the "Preferred Stock"), see "Description of
Securities -- Preferred Stock," to convert such shares into an aggregate of
3,789,683 shares of Common Stock to be effective upon the closing of the
Offering (the "Preferred Stock Conversion"). All references to the "Company" or
"Anthra" herein include Anthra Pharmaceuticals, Inc. and its wholly owned United
Kingdom subsidiary, Anthra Pharmaceuticals Ltd., unless the context otherwise
requires. Unless otherwise indicated, all references to years refer to calendar
years.
THE COMPANY
Anthra Pharmaceuticals, Inc. is a specialized pharmaceutical company
engaged in managing clinical development and obtaining regulatory approval of
New Drug Applications ("NDAs") and supplemental NDAs ("sNDAs") for a portfolio
of its proprietary cancer drugs. The Company's current drug candidates are for
the treatment of patients with superficial cancer of the bladder, ovarian and
prostatic cancer, and complications from metastatic cancer (hypercalcemia and
lytic bone disease). The Company's strategy is to develop only late stage drug
candidates, thereby improving the likelihood of successfully obtaining NDA/sNDA
and equivalent foreign approvals. The Company directs its search for oncology
drug candidates toward selected large pharmaceutical companies, because of the
difficulty many of these companies have experienced in managing oncology
projects, and at biotechnology and early stage discovery companies that lack
clinical and regulatory proficiency. To maximize the return on its investment in
each drug, Anthra seeks approvals for multiple disease indications for each
product and directly manages both its United States and foreign clinical
programs and regulatory submissions. At the present time, Anthra has entered
into four marketing agreements with major multinational drug companies for which
it has received certain initial payments and expects significant additional
payments in the form of milestone fees and royalty and supply payments.
In December 1997, Anthra filed an NDA for its first product, Valstar(TM)
(valrubicin, AD 32) ("Valstar(TM)"), for treatment of patients with superficial
bladder cancer whose principal current alternative is the surgical removal of
their urinary bladder. In January 1998, Anthra received priority designation
from the United States Food and Drug Administration (the "FDA") for the review
of this NDA. On June 1, 1998, the Oncologic Drugs Advisory Committee ("ODAC")
reviewed Valstar(TM), and declined to recommend approval to the FDA of
Valstar(TM) without additional analyses. On September 1, 1998, ODAC re-evaluated
Valstar(TM) and voted to recommend to the FDA approval of Valstar(TM) for
treatment of patients with BCG-refractory carcinoma in-situ with a medical
contraindication to cystectomy (the "ODAC Recommended Indication"). The Company
anticipates that the NDA for Valstar(TM) for this indication will be approved by
the FDA in 1998.
Valstar(TM) is an anthracycline with multiple cytotoxic mechanisms that was
discovered at the Dana-Farber Cancer Institute, Harvard University Medical
School ("Dana-Farber"). Valstar(TM) has been shown to have significant activity
against a variety of tumor cell lines and is not associated with significant
contact toxicity, thereby making it an ideal choice for regional chemotherapy.
The Company's pivotal clinical studies, have demonstrated a complete response
rate of 18% (which rate was supported by the FDA) in a group of 90 patients with
bladder cancer who had not responded satisfactorily to extensive pre-treatment
with Bacillus Calmette Guerin ("BCG"), the accepted first line treatment for
superficial bladder cancer. There are currently no drugs approved in the United
States or Europe for second-line treatment of bladder cancer following BCG
therapy. For these patients, surgical removal of the bladder is the only
approved definitive form of therapy. Importantly, 35% of the patients in the
Company's pivotal clinical studies retained their bladder up to 48 months
following study entry. Anthra, consistent with its multiple disease indication
strategy, is developing Valstar(TM) for three additional indications. One Phase
III program is directed at patients with papillary superficial bladder cancer,
for whom approximately 180,000 transurethral resection procedures are being
performed annually in the United States. In another Phase III program involving
patients with ovarian
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cancer, Valstar(TM) is being administered directly into the peritoneal cavity,
where the cancer is confined. In addition, Anthra plans to commence a Phase I
program to obtain approval for use of Valstar(TM) in treating prostate cancer.
The Company has researched the historical incidence of each of these diseases
based on publicly available information and reports prepared for the Company by
MedProbe, Inc. ("MedProbe"), including a report summarizing the results of a
survey of 1.5% (124) of office and hospital based urologists reported to be
members of the American Medical Association ("AMA"). Although precise patient
data is not published and can vary significantly from year to year, based on the
foregoing research and certain assumptions made by the Company, including the
estimated cost of treating each of the estimated number of patients with
Valstar(TM), the Company estimates that the potential market for Valstar(TM) in
the United States could approximate nearly $600 million per annum, see
"Business -- Products and Markets -- Valstar(TM): Market," and that foreign
markets will provide a significant additional opportunity for sales of
Valstar(TM). No assurance can be given by the Company that this estimated market
for Valstar(TM) will be achieved.
A United States subsidiary of Medeva plc (collectively with Medeva plc,
"Medeva") has committed up to $26.2 million (of which $10.1 million has been
paid to date) and the payment of future royalties for the right to market and
sell Valstar(TM) in the United States. Anthra currently has similar arrangements
for Valstar(TM) with Nycomed Pharma AS ("Nycomed"), and Almirall Prodesfarma,
S.A. ("Almirall"), with respect to marketing and sales rights in Europe. In
total, Anthra has entered into agreements for Valstar(TM) providing potential
equity investment, licensing and development fees and milestone payments of up
to $42.9 million (of which $24.4 million has been paid to date), plus additional
royalty and supply payments.
In accordance with the Company's corporate development strategy, Anthra
identified Bonefos(R), a product for the treatment of hypercalcemia and lytic
bone disease associated with breast and lung cancer and owned by Schering AG,
Germany, the Company's largest pharmaceutical shareholder. Bonefos(R) has been
on the market in Europe and the rest of the world since 1985, with worldwide
sales of approximately $150 million in 1997. In July 1998, Anthra entered into
an Option Agreement (the "Bonefos Option Agreement") with Schering AG, Germany's
affiliates, Berlex Laboratories, Inc. ("Berlex") and Leiras Oy, to acquire the
exclusive United States development and marketing rights to Bonefos(R) for the
hypercalcemia and lytic bone disease indications, for payments aggregating $3.75
million, including a nonrefundable $250,000 payment under a prior term sheet. In
consideration of the Company's nonrefundable payment of $200,000 (also included
in the $3.75 million), the Bonefos Option Agreement grants the Company the
option to enter into a development and commercialization agreement with Berlex
and Leiras Oy and a manufacturing agreement with Leiras Oy, both of which have
been fully negotiated (collectively, the "Bonefos Agreements"). The Company
intends to exercise this option prior to the expiration of the option on
September 30, 1998, by making an additional nonrefundable $800,000 payment to
Leiras Oy. Following the execution of the Bonefos Agreements in conjunction with
the Company's exercise of its option under the Bonefos Option Agreement, the
Company plans to conduct Phase III trials in the United States for Bonefos(R)
for the hypercalcemia and lytic bone disease indications. The Bonefos Agreements
provide that, upon FDA approval of an NDA for Bonefos(R), Berlex will have the
option to acquire from the Company the exclusive right to market Bonefos(R) in
the United States for the hypercalcemia and lytic bone disease indications for
payments of up to $21 million, plus future royalties. The Company has researched
the historical incidence of hypercalcemia and the types of lytic bone disease
that Bonefos(R) treats based on publicly available information. Although precise
patient data is not published and can vary significantly from year to year,
based on the foregoing research and certain assumptions made by the Company,
including the estimated costs of utilizing Bonefos(R) for the treatment of these
maladies using each of the estimated number of patients, the Company estimates
that the potential market for Bonefos(R) in the United States could approximate
nearly $900 million per annum. See "Business -- Products and
Markets -- Bonefos(R): Market." No assurance can be given by the Company that
this estimated market for Bonefos(R) will be achieved.
Anthra believes that its strategy and accomplishments have positioned it to
become a recognized platform for the clinical substantiation and regulatory
approval of cancer drugs capable of treating multiple disease indications. The
Company is currently assessing and evaluating additional cancer-related late
stage candidates for acquisition, although no definitive agreements have been
executed. Management believes that focused, cost effective development increases
the likelihood of successful clinical development and regulatory approval.
Indicative of this strategy has been the Company's success in filing an NDA for
Valstar(TM) at a total cost of less than $20 million. According to Parexel's
Pharmaceutical Statistical Sourcebook (1997) ("PPSS"), in the
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United States, the cost of developing an approved new drug has been estimated to
be between $304 million and $608 million.
The Company currently manages its clinical development program for the
United States from Princeton, New Jersey, and its program for Europe from
Princes Risborough, England through Anthra Pharmaceuticals Ltd., its wholly
owned United Kingdom subsidiary ("Anthra UK"). The Company further anticipates
that it may manage the manufacturing, supply, development and distribution of
Valstar(TM) and Bonefos(R) from Switzerland through one or more wholly owned
Swiss subsidiaries, which would hold substantially all of the Company's rights
to Valstar(TM) and Bonefos(R).
The Company was incorporated in Delaware on June 25, 1985. The Company's
principal executive offices are located at 103 Carnegie Center, Suite 102,
Princeton, New Jersey 08540 and its telephone number is (609) 514-1060.
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THE OFFERING
Securities offered.............. 2,000,000 Units, each Unit consisting of one
share of Common Stock and one Warrant to
purchase one share of Common Stock. The
Common Stock and the Warrants that make up
the Units will trade only as separate
securities one year after the date of this
Prospectus. See "Description of Securities."
Common Stock to be outstanding
after the Offering.............. 6,855,183 shares(1)
Warrants to be outstanding after
the Offering.................... 2,000,000(2)
Terms of Warrants............... Each Warrant entitles the holder to purchase
one share of Common Stock at a price of $6.00
per share. The Warrants are exercisable at
any time beginning on the Separation Date
unless previously redeemed, until the fifth
anniversary of this Prospectus, subject to
certain conditions. The Company may redeem
the Warrants, in whole or in part, on or
after the date 15 months from the date of
this Prospectus upon at least thirty days'
prior written notice to the registered
holders thereof, at a price of $.10 per
Warrant, provided that (i) the last sales
price of the Common Stock as reported on the
American Stock Exchange has been at least
$9.00 for at least 20 consecutive trading
days ending within ten days of the date of
the notice of redemption and (ii) there is a
current registration statement covering the
resale of the underlying shares of Common
Stock.
Use of proceeds................. Progress payments for the acquisition of
Bonefos(R), for development of products, and
for general corporate purposes, including
potential additional product acquisitions and
purchases of product inventory. See "Use of
Proceeds."
Proposed American Stock Exchange
symbols....................... Units -- "APU" (until the Separation Date)
Common Stock -- "APX" (on and after the
Separation Date)
Warrants -- "APW" (on and after the
Separation Date)
Risk Factors.................... This Offering involves a high degree of risk.
See "Risk Factors."
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(1) Based on shares of Common Stock outstanding at June 30, 1998 and assuming
the Company is successful in obtaining from all of the holders of Preferred
Stock agreements to convert their shares and the resultant conversion of an
aggregate of 3,789,683 shares of Preferred Stock into an aggregate of
3,789,683 shares of Common Stock effective upon the closing of the Offering.
Does not include (a) 1,535,487 shares of Common Stock issuable upon exercise
of stock options outstanding at June 30, 1998, with a weighted average
exercise price of $3.01 per share, of which options to purchase 509,757
shares of Common Stock were then exercisable (see "Capitalization" and
"Management") (options to purchase 199,532 shares of Common Stock have been
cancelled after June 30, 1998), (b) certain stock options to purchase Common
Stock or Series D Convertible Preferred Stock which may be granted to
Nycomed pursuant to the Nycomed Agreement (see "Business -- Products and
Market -- Valstar(TM): Licensing Agreements"), (c) 2,000,000 shares of
Common Stock issuable upon exercise of the Warrants, and (d) 400,000 shares
of Common Stock issuable on the exercise of the Units underlying the
Underwriter's Warrant and the Warrants underlying such Units.
(2) Does not include 200,000 Warrants issuable upon the exercise of the Units
underlying the Underwriter's Warrant.
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9
SUMMARY FINANCIAL DATA
(IN THOUSANDS, EXCEPT PER SHARE DATA)
TWELVE MONTHS ENDED JUNE 30,
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1994 1995 1996 1997 1998
----------- ------- ------- ------- -----------
(UNAUDITED)
CONSOLIDATED STATEMENT OF OPERATIONS DATA:
Revenue....................................... $ -- $ -- $ 2,171 $ 1,688 $ --
Total operating expenses...................... 2,489 2,712 4,172 7,292 11,106
Other income (expense)........................ 37 94 111 139 359
------- ------- ------- ------- --------
Net loss...................................... $(2,452) $(2,618) $(1,890) $(5,465) $(10,747)
======= ======= ======= ======= ========
Net loss allocable to common stockholders..... $(2,874) $(3,271) $(2,543) $(6,118) $(11,400)
======= ======= ======= ======= ========
Basic and diluted net loss per share allocable
to common stockholders(1)................... $ (4.02) $ (4.24) $ (3.01) $ (5.79) $ (10.70)
Shares used in computing basic and diluted net
loss per share allocable to common
stockholders(1)............................. 716 771 844 1,057 1,066
JUNE 30, 1998
------------------------------------------
PRO FORMA AS
ACTUAL PRO FORMA(2) ADJUSTED(2)(3)
-------- ------------ --------------
(UNAUDITED) (UNAUDITED)
CONSOLIDATED BALANCE SHEET DATA:
Cash and cash equivalents............................ $ 2,912 $ 2,912 $ 11,042
Working capital...................................... 635 635 9,316
Total assets......................................... 4,100 4,100 11,348
Contingent stock obligation(4)....................... 8,000 8,000 8,000
Mandatorily redeemable convertible preferred stock... 11,623 -- --
Convertible preferred stock.......................... 6 -- --
Deficit accumulated during the development stage..... (25,616) (25,616) (25,616)
Total stockholders' equity (deficit)................. (17,849) (6,226) 1,574
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(1) See Note 2 of Notes to Consolidated Financial Statements.
(2) The Company is currently attempting to obtain agreements from all of the
holders of Preferred Stock to convert all of their shares of Preferred Stock
into the same number of shares of Common Stock upon the closing of the
Offering. The amounts presented assume that the Company obtains the
conversion agreements from each holder of Preferred Stock and the resultant
conversion of all issued and outstanding shares of Preferred Stock into
3,789,683 shares of Common Stock effective upon the closing of the Offering.
If the Company does not obtain such conversion agreements, the pro forma as
adjusted stockholders' equity (deficit) would be $(10,049,000), convertible
preferred stock would be $6,000 and mandatorily redeemable convertible
preferred stock would be $11,623,000.
(3) As adjusted to give effect to the sale of the 2,000,000 Units by the Company
offered hereby at an assumed initial public offering price of $5.00 per
Unit, less underwriting discounts and commissions and estimated offering
expenses, and the anticipated application of the estimated net proceeds
therefrom. See "Use of Proceeds" and "Capitalization."
(4) See Note 5 of Notes to Consolidated Financial Statements.
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RISK FACTORS
In addition to the other information in this Prospectus, investors should
carefully consider the following risk factors when evaluating an investment in
the securities offered hereby. The Company cautions prospective investors that
the following list of risk factors may not be exhaustive.
Certain statements contained in "Prospectus Summary," "Risk Factors,"
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" and "Business," including statements regarding the anticipated
development and expansion of the Company's business, the products which the
Company expects to offer, anticipated research and development expenditures and
regulatory reform, the intent, belief or current expectations of the Company,
its Directors or its officers, primarily with respect to the future operating
performance of the Company, other statements contained herein regarding
performance of the Company, and other statements contained herein regarding
matters that are not historical facts, are forward-looking statements. Because
such statements include risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking statements.
These statements appear in a number of places in this Prospectus and include
statements regarding the intent, belief or current expectations of the Company,
its Directors or its officers with respect to, among other things: (i) whether
the Company will receive, and the timing of, regulatory approvals or clearances
to market Valstar(TM) and Bonefos(R) and any other potential products; (ii) the
results of current and future clinical trials; and (iii) the time and expenses
associated with the regulatory approval process for products. The success of the
Company's business operations is in turn dependent on factors such as the
receipt and timing of regulatory approvals or clearances for potential products,
the effectiveness of the Company's marketing strategies to market its current
and any future products, the Company's ability to enter into agreements for the
manufacture of its products on a commercial scale, the appeal of the Company's
mix of products, the Company's success at entering into and collaborating with
others to conduct effective strategic alliances and joint ventures, general
competitive conditions within the biotechnology and pharmaceutical industry, and
general economic conditions. Factors that could cause actual results to differ
materially from those expressed or implied by such forward-looking statements
include, but are not limited to, the factors set forth in "Risk Factors,"
"Management's Discussion and Analysis of Financial Condition and Results of
Operations" and "Business."
History of Losses; Accumulated Deficit and Anticipated Future Losses. To
date, the Company has been engaged primarily in clinical research and
development activities and has generated revenues only recently. At June 30,
1998, the Company had an accumulated deficit of $25.6 million since inception
and losses are expected to continue through fiscal year 1999. The Company will
be required to conduct substantial clinical research and development for all of
its current and proposed products, which activities are expected to result in
operating losses for the foreseeable future. In addition, to the extent the
Company relies upon others for commercialization activities, the Company's
ability to achieve profitability will be dependent upon the success of such
third parties. The extent and duration of future losses is highly uncertain, and
there can be no assurance that the Company will be able to achieve profitability
on a sustained basis, if at all.
Future Capital Needs and Commitments; Uncertainty of Additional
Funding. The Company anticipates that its existing resources, including the net
proceeds of the Offering and contingent funding from Medeva, Berlex (assuming
the exercise by the Company of its option under the Bonefos Option Agreement to
enter into the Bonefos Agreements), Nycomed and Almirall (collectively, the
"Collaborative Partners"), will be sufficient to fund the Company's operating
expenses and capital requirements through fiscal 1999. There can be no
assurance, however, that the results of research and development activities,
potential relationships with strategic partners, changes in the focus and
direction of the Company's research and development programs, competitive and
technological advances, the regulatory approval process, and other factors, will
not result in the exhaustion of the Company's resources before such time. The
Company will require substantial funds in addition to the proceeds of the
Offering to conduct research and development activities, clinical trials, and
apply for regulatory approvals for any potential products in addition to
Valstar(TM) and Bonefos(R). If the Company engages directly in such activities
or in the event scheduled payments are not made by Collaborative Partners or any
related agreements are terminated, such events could materially and adversely
affect the Company's business, financial condition and results of operations.
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The Independent Auditors' Report covering the June 30, 1998 consolidated
financial statements included elsewhere herein, contains an explanatory
paragraph which states that the Company's recurring losses from operations, net
capital deficiency and insufficient working capital raise substantial doubt
about the Company's ability to continue as a going concern. The consolidated
financial statements do not include any adjustments that might result from the
outcome of that uncertainty.
The Company may seek additional funding through collaborative arrangements
and public or private financings, including equity financings. There can be no
assurance that such collaborative arrangements or additional financing will be
available on acceptable terms, if at all. If additional funds are raised by
issuing equity securities, further dilution to stockholders may result. If
adequate funds are not available, the Company may be required: (i) to delay,
reduce the scope of or eliminate one or more of its development programs or
forfeit its rights to licensed products or technologies; (ii) to obtain funds
through arrangements with collaborative partners or others that may require the
Company to relinquish rights to certain of its technologies, product candidates
or products that the Company would otherwise seek to develop or commercialize
itself; or (iii) to license the rights to such products on terms that are less
favorable to the Company than might otherwise be available. Any of the foregoing
developments could have a material adverse effect upon the Company's business,
financial condition and results of operations. See "Use of Proceeds" and
"Management's Discussion and Analysis of Financial Condition and Results of
Operations."
Limited History of Product Development. The Company has no products
approved for sale. The Company has filed an NDA with the FDA for Valstar(TM) for
treatment of refractory carcinoma in-situ of the bladder, and has clinical
trials in progress or planned for three other disease indications for
Valstar(TM). Although ODAC has recommended to the FDA that it approve
Valstar(TM) for the ODAC Recommended Indication, such recommendation is not
binding on the FDA. In addition, there can be no assurance that the FDA will
follow ODAC's recommendation with respect to the ODAC Recommended Indication or
that the FDA will grant the Company approval with respect to the ODAC
Recommended Indication, or that any of the clinical trials in progress will
either have successful results or lead to approved sNDAs for other indications.
Failure to obtain such approvals would have a material adverse effect on the
Company's business, financial condition and results of operations.
The Company has entered into the Bonefos Option Agreement to obtain
development and marketing rights for the United States market for a second
product, Bonefos(R), for the hypercalcemia and lytic bone disease indications.
The Bonefos Option Agreement grants the Company the option to enter into the
Bonefos Agreements, which the Company intends to exercise by making a
non-refundable $800,000 payment to Leiras Oy prior to the expiration of the
option on September 30, 1998. Bonefos(R) is the subject of an ongoing clinical
trial with respect to one indication. The Company plans to commence clinical
trials for a second indication for Bonefos(R) upon the execution of the Bonefos
Agreements in conjunction with the exercise by the Company of its option under
the Bonefos Option Agreement. However, there can be no assurance that either of
the clinical trials will be completed with successful results or that such
results will lead to the successful filing and approval of this product for any
indication. There also can be no assurance that the Company can meet certain
financial covenants contained in the Bonefos Agreements which if not met, allow
for termination of such agreements.
Before obtaining regulatory approval for commercial sale, a product
candidate must be shown through preclinical and clinical trials that it is safe
and effective for use in each target indication. The results from preclinical
and early clinical trials may not be predictive of results that will be obtained
in large-scale clinical trials. There can be no assurance that clinical trials
of the Company's product candidates will demonstrate sufficient safety and
efficacy to obtain the requisite regulatory approvals or will result in
marketable products.
While the Company has submitted an NDA to the FDA with respect to
Valstar(TM) for the treatment of refractory carcinoma in-situ of the bladder,
results obtained with respect to the clinical trials for this indication for
Valstar(TM) may not be representative of results of clinical trials for other
indications. The pivotal Phase III studies of Valstar(TM) for other indications
seek efficacy data, as well as additional safety data, and will require
substantial time and significant funding. There can be no assurance that
clinical studies for additional indications for Valstar(TM) currently under
development will be completed successfully within any specified time
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period, if at all. Further, there can also be no assurance that such testing
will show Valstar(TM) to be safe or effective for these indications. There can
be no assurance that the Company will not encounter problems in clinical trials
that will cause the Company to delay or suspend clinical trials. If the
Company's product candidates are not shown to be safe and effective in clinical
trials, there would be a material adverse effect on the Company's business,
financial condition and results of operations. See "Business -- Products and
Markets."
Short-Term Dependence on Valstar(TM). The Company filed an NDA for
approval to market Valstar(TM) for the treatment of patients with carcinoma
in-situ of the bladder, whose principal current alternative is surgical removal
of their urinary bladder. Two additional indications are being investigated in
two Phase III trials, and the Company anticipates that it will investigate a
fourth indication in a Phase I trial. Valstar(TM) has not been approved for
marketing by the FDA or any foreign regulatory agency for any indication, and
trials to date have involved a limited number of patients. There can be no
assurance that marketing approval for Valstar(TM) for any indication will be
obtained. If Valstar(TM) is approved for marketing, there can be no assurance
that it will gain market acceptance or that the marketing efforts necessary to
gain any such acceptance will prove effective or not cost more than the benefit
gained thereby. In addition, competition to Valstar(TM) may develop from other
new and existing products. The failure of Valstar(TM) to be approved for
marketing or to gain market acceptance would have a material adverse effect on
the Company's business, financial condition and results of operations. While the
Company has executed the Bonefos Option Agreement regarding the acquisition of
development and marketing rights for the United States market for Bonefos(R) for
the hypercalcemia and lytic bone disease indications, and intends to exercise
its option thereunder to enter into the Bonefos Agreements, there can be no
assurance, that regulatory approval will be obtained for Bonefos(R) for such
indications in the United States or that Bonefos(R) can be successfully
commercialized for such indications in the United States.
The number of patients in the United States with refractory carcinoma
in-situ of the bladder is limited and may be as few as 5,000 patients per annum.
In order to increase the number of indications for which Valstar(TM) may be
used, the Company must (i) successfully complete large clinical trials
demonstrating that drug activity is sufficient in each indication, (ii) file
sNDAs for and obtain marketing clearance from the FDA for each additional
indication, following approval of the NDA, (iii) make similar filings with and
obtain similar approvals from foreign regulatory agencies, and (iv) provide
support for the successful market launch and penetration of the product. There
can be no assurance that the Company will successfully complete the required
clinical trials and receive approvals for the additional indications on a timely
basis, if at all, or successfully market the product. Such an inability would
have a material adverse effect on the Company's business, financial condition
and results of operations. See "Business -- Government Regulation."
Uncertainties Related to Clinical Trials. The Company has limited
experience in conducting multiple clinical trials. Before obtaining regulatory
approval for the commercial sale of its products and their respective
indications, the Company is required to demonstrate through preclinical studies
and clinical trials that the products are safe and effective for use in each
target indication. The results from preclinical studies and early clinical
trials may not predict the results that will be obtained in large-scale testing,
and there can be no assurance that the clinical trials conducted by the Company
or its partners will demonstrate sufficient safety and efficacy to obtain
required regulatory approvals or will result in marketable products. In
addition, clinical trials are often conducted with patients having the most
advanced stage of disease. During the course of treatment, these patients may
die or suffer other adverse medical effects for reasons that are not related to
the pharmaceutical agent being tested, but which can nevertheless affect
clinical trial results. A number of companies in the pharmaceutical and
biotechnology industries have suffered significant setbacks in advanced clinical
trials, even after achieving promising results in earlier trials.
The completion of clinical trials of the Company's product candidates could
be delayed or terminated by many factors and there can be no assurance that such
delays or terminations will not occur. One such factor is the rate of enrollment
of patients, which generally varies throughout the course of a clinical trial
and which depends upon the size of the patient population, the number of
clinical trial sites, the proximity of patients to clinical trial sites, the
eligibility criteria for the clinical trial, and the existence of competitive
clinical trials. The Company cannot control the rate at which patients present
themselves for enrollment, and there can be no
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assurance that the rate of patient enrollment will be consistent with the
Company's expectations or be sufficient to enable clinical trials of the
Company's product candidates to be completed in a timely manner. Any delays in,
or termination of, the clinical trials of any of the Company's product
candidates could have a material adverse effect on the Company's business,
financial condition and results of operations.
There is also the possibility that unacceptable side effects will be
discovered during preclinical or clinical testing of the Company's products.
Even after approval for marketing, a product may later be shown to be
ineffective or to have unacceptable side effects not discovered during testing,
requiring limitations on its use or withdrawal from the market.
Dependence on Licensees and Other Third Parties. The Company does not
intend to market any of its product candidates directly in the foreseeable
future. The Company has granted the right to commercialization and marketing
activities relating to Valstar(TM) to various licensees with respect to certain
territories. See "Business -- Products and Markets -- Valstar(TM): Licensing
Agreements." Pursuant to the Company's agreement with Medeva covering the United
States, the Company received an initial non-refundable payment of $8 million and
an additional $2.1 million payment for having manufactured certain batches of
Valstar(TM) acceptable to the FDA in a pre-approval inspection. The Company will
not receive the additional payments aggregating up to $16.0 million unless
certain other milestones are achieved. Under the Company's agreement with
Nycomed covering, among other territories, certain parts of Western and Eastern
Europe and Russia, Nycomed made a $4.5 million equity investment in the Company,
but is only obligated to make certain additional payments, aggregating up to $2
million, upon the attainment by Anthra of certain milestones. The Company will
also be obligated to issue certain options to purchase additional equity in the
Company upon the achievement of certain milestones. Pursuant to the Company's
agreement with Almirall covering Spain and Portugal, Anthra received an initial
licensing payment of $200,000 and an equity investment of approximately
$750,000, and may receive additional payments aggregating up to $400,000 if
certain milestones are achieved. The Company is also entitled to royalty and/or
supply payments under the Medeva, Nycomed and Almirall agreements and, although
each of such agreements has a minimum term of 10 years, the commencement date
for such payments under each agreement will remain undetermined until
Valstar(TM) is approved for sale in the relevant jurisdiction. Accordingly, the
Company is substantially dependent on these licensees for the funding necessary
to support, and the commercial success of, this product candidate. In the event
that any of the licensees subsequently terminates its agreement with the Company
or otherwise fails to conduct its collaborative activities successfully and in a
timely manner, the commercialization of the licensed Valstar(TM) product
candidate could be delayed. Any such delay could have a material adverse effect
on the Company's business, financial condition and results of operations.
Furthermore, if the Company exercises its option under the Bonefos Option
Agreement to enter into the Bonefos Agreements as is its intention, and Berlex
should exercise its option to acquire the United States marketing rights for
Bonefos(R) for the hypercalcemia and lytic bone disease indications, the Company
would be dependent upon the marketing efforts of Berlex with respect thereto.
The Company has no experience in sales, marketing or distribution and is
relying on its licensing arrangements pursuant to which third parties will sell,
market and distribute its products. The Company is currently dependent to a
significant extent on corporate partners, licensees and other entities for
manufacturing and marketing of its products. If the Company engages directly in
manufacturing or marketing, the Company will require substantial additional
funds and personnel and will be required to comply with extensive regulations
applicable to such activities. There can be no assurance that the Company will
be able to develop or contract for these capacities when required in connection
with the Company's business. Any revenues received by the Company will depend
upon the efforts of third parties, and there can be no assurance that such
efforts will be successful. See "Business -- Products and Markets."
The Company intends to enter into additional corporate alliances to develop
and commercialize products. The Company may grant to its collaborative partners
rights to commercialize any products developed under or covered by these
collaborative agreements. The amount and timing of resources devoted to these
activities generally will be controlled by each such individual partner. There
can be no assurance that such corporate partners will successfully commercialize
any such products or will not pursue alternative technologies or develop
competitive products for the treatment of the diseases targeted by the Company's
programs.
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There can be no assurance that the Company will be successful in
establishing any additional collaborative arrangements, that products will be
successfully commercialized under any collaborative arrangement or that the
Company will derive any revenues from such arrangements. In addition, the
Company's strategy involves entering into multiple, concurrent strategic
alliances to pursue commercialization of its products. There can be no assurance
that the Company will be able to manage simultaneous alliances successfully.
With respect to existing and potential future strategic alliances and
collaborative arrangements, the Company will be dependent upon the expertise and
dedication of sufficient resources by these outside parties to manufacture
and/or market products. Should a strategic alliance partner or collaborative
partner fail to commercialize a product to which it has rights, the Company's
business, financial condition and results of operations could be materially and
adversely affected.
Uncertainty of Government Regulatory Requirements; Lengthy Approval
Process. The research, development, preclinical and clinical trials,
manufacturing, labeling, and marketing related to the Company's products are
subject to an extensive regulatory approval process by the FDA and other
regulatory agencies in the United States and abroad. The process of obtaining
FDA and other required regulatory approvals for drug and biologic products,
including required preclinical and clinical testing, is lengthy, expensive and
uncertain. There can be no assurance that, even after such time and
expenditures, the Company will be able to obtain necessary regulatory approvals
for clinical testing or for the manufacturing or marketing of any products or
that the approved labeling will be sufficient for favorable marketing and
promotional activities. The Company may encounter significant delays or
excessive costs in its efforts to secure necessary approvals or licenses. Even
if regulatory clearance is obtained, a marketed product is subject to continual
review, and later discovery of previously unknown defects or failure to comply
with the applicable regulatory requirements may result in restrictions on a
product's marketing or withdrawal of the product from the market as well as
possible civil or criminal sanctions.
Satisfying regulatory requirements, which includes demonstrating to the
satisfaction of appropriate regulatory authorities, such as the FDA, that the
relevant product is both safe and effective, typically takes several years or
more depending upon the type, complexity and novelty of the product and requires
the expenditure of substantial resources. There can be no assurance that the
Company will not encounter problems in clinical trials which would cause the
Company or the FDA or other regulatory body to delay or suspend clinical trials.
Any such delay or suspension could have a material adverse effect on the
Company's business, financial condition and results of operations. Even after
approval, marketed products are subject to continuing FDA review, and they can
be withdrawn from the market, or new limitations placed on their labeling,
marketing, distribution, manufacture, or use, if new side effects are discovered
or if the products are shown to be less effective than previously believed. See
"Business -- Products and Markets" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations."
As with all specialized pharmaceutical companies, biotechnology companies,
large pharmaceutical companies and drug delivery companies, there can be no
assurance that FDA or other regulatory approvals for any of Anthra's
pharmaceutical products will be granted on a timely basis, if at all. The FDA
and comparable agencies in foreign countries impose substantial requirements on
the introduction of new pharmaceutical products through lengthy and detailed
preclinical and clinical testing procedures, sample testing and other costly and
time-consuming compliance procedures. For example, clinical trials subject to
FDA review are rigorously regulated and must meet requirements for FDA review
and oversight, and requirements under Good Clinical Practice guidelines. A new
drug may not be marketed in the United States until it has been approved by the
FDA, or marketed in foreign countries until it has been approved by the
appropriate regulatory authorities for such countries. There can be no assurance
that the Company will not encounter delays or rejections or that the FDA or
other applicable regulatory agency will not make policy changes during the
period of product development and regulatory review of each submitted NDA or
sNDA, or other appropriate documentation. A delay in obtaining or failure to
obtain such approvals would have a material adverse effect on the Company's
business, financial condition and results of operations. Even if regulatory
approval is obtained, the labeling would be limited as to the indicated uses for
which the product may be promoted or marketed. A marketed product, its
manufacturer and the facilities in which it is manufactured are subject to
continual review and periodic inspections. If marketing approval is granted, the
Company would be
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required to comply with FDA or other applicable regulatory agency requirements
for manufacturing (including compliance with current Good Manufacturing Practice
("cGMP") requirements), labeling, advertising, record keeping and reporting of
adverse experiences, and other information. In addition, the Company would be
required to comply with Federal and state anti-kickback and other health care
fraud and abuse laws, and their foreign law equivalents, that pertain to the
marketing of pharmaceuticals. Failure to comply with regulatory requirements and
other factors could subject Anthra to regulatory or judicial enforcement
actions, including, but not limited to, product recalls or seizures,
injunctions, withdrawals of product from the market, civil penalties, criminal
prosecution, and withdrawals of existing approvals, as well as enhanced product
liability exposure, any of which could have a material adverse effect on the
Company's business, financial condition and results of operations. See
"Business -- Government Regulation."
The Company has obtained from the FDA a designation for Valstar(TM) as an
"orphan drug" ("Orphan Drug"), under the provisions of the Orphan Drug Act of
1983, as amended (the "Orphan Drug Act"), for the treatment of carcinoma in-situ
of the bladder. Although Orphan Drug status may provide an applicant exclusive
marketing rights in the United States for a drug for a designated indication for
seven years following marketing approval, in order to obtain such benefits, the
applicant must be the sponsor of the first NDA approved for that drug and
indication. In addition, Orphan Drug exclusivity does not prohibit the FDA from
approving the same drug manufactured by another sponsor if it is labeled for a
different indication (even if it can be used for the same indication) or if it
is clinically superior to the Orphan Drug in any respect. Moreover, amendment of
the Orphan Drug Act by the United States Congress and reinterpretation by the
FDA are frequently discussed. Therefore, there can be no assurance as to the
precise scope of protection that may be afforded by Orphan Drug status in the
future, or that the current level of exclusivity will remain. See
"Business -- Government Regulation."
Competition. The pharmaceutical and biopharmaceutical industries are
intensely competitive and competition from other pharmaceutical companies,
biotechnology companies and other research and academic institutions is expected
to increase. Many of these companies have substantially greater financial and
other resources and research and development capabilities than the Company and
have substantially greater experience in undertaking preclinical and clinical
testing of products, obtaining regulatory approvals and manufacturing and
marketing pharmaceutical products. The Company is aware of other companies
engaged in the development of anthracycline drugs as chemotherapeutic agents for
various disease indications, including Pharmacia-Upjohn, Aronex, Sequus, Nexstar
and Liposome Company, and a number of other companies and academic institutions
are pursuing anthracycline drug research and are testing other anthracycline
drugs. Valstar(TM) may compete for certain uses with numerous other
anthracycline drug products in development by others. In addition to these
companies and institutions involved in the development of anthraycycline drugs,
many other companies have developed products which may compete with Valstar(TM).
These companies include Zeneca, Bristol-Myers Squibb, American Home Products,
SmithKline Beecham, Eli Lilly, Roche, Schering Plough, Bioniche Inc., Mentor and
Takeida-Abbott, all of which develop or commercialize anti-cancer therapies.
With respect to the treatment of prostate cancer, Anthra also faces competition
from companies developing radioactive seed implantation therapies, including
Amersham/Mediphysics, North American Scientific, Theragenics, Imagyn Medical
Technologies and International Isotopes. Furthermore, companies also exist that
compete with Bonefos(R) by developing other bisphosphonates for the treatment of
hypercalcemia and lytic bone disease. These companies include Proctor & Gamble,
Sanofi, Novartis, Merck and MGI Pharmaceutical. There can be no assurance that
the Company will develop products that are as effective as or achieve greater
market acceptance than competitive products, or that the Company's competitors
will not succeed in developing products and technologies either that are as
effective as those being developed by the Company or that would render the
Company's products and technologies less competitive or obsolete.
Dependence on Patents and Other Proprietary Rights, Uncertainty of Patent
Position and Proprietary Rights. Valstar(TM) is no longer protected by the
rights afforded to the Company by patent protection as a new molecular entity
("NME"). The FDA has designated Valstar(TM) as an Orphan Drug for carcinoma
in-situ, and the Company expects to apply for Orphan Drug designation for
Valstar(TM) in other disease indications. Orphan Drug designation grants a
company market exclusivity in the indication for a period of seven years after
FDA approval if it receives the first approval of the Orphan Drug for that
indication. If another sponsor
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receives the first approval, this would prevent the Company from receiving
approval for seven years. There can be no assurance the Company will be granted
Orphan Drug status for any additional product or indication or that such status
will not be challenged, invalidated or circumvented, or that the rights granted
thereunder will provide proprietary protection to the Company or that another
sponsor will not receive Orphan Drug exclusivity first that would block the
Company's ability to obtain its own approval. See "Business -- Government
Regulation."
Bonefos(R) is the subject of several United States patents and patent
applications with expiration dates commencing in 2010 and ending in 2014. The
FDA has designated Bonefos(R) as an Orphan Drug for the treatment of osteolysis
(hypercalcemia). There can be no assurance that Bonefos(R) will be granted
Orphan Drug status for the treatment of lytic bone disease or that such status
will not be challenged, invalidated or circumvented, or that the rights granted
thereunder will provide proprietary protection to the Company.
Furthermore, the enactment of the legislation implementing the General
Agreement on Trade and Tariffs resulted in certain changes to United States
patent laws effective June 8, 1995. More notably, the term of patent protection
for patent applications filed on or after June 7, 1995 is no longer a period of
17 years from the date of grant, but will commence on the date of issuance and
terminate 20 years from the earlier effective filing date of the application.
Because the time from filing to issuance of an NME patent application is often
more than three years, a 20 year term from the effective date of filing may
result in a substantially shortened term of patent protection, which may
adversely impact the Company's patent position. If this change results in a
shorter period of patent coverage for future products, the Company's business,
financial condition and results of operations could be adversely affected to the
extent that the duration and level of the royalties it is entitled to receive
from a collaborative partner is based on the existence of a valid patent.
The Company's potential products may infringe on patents that have been or
may be granted to competitors, universities or others. The Company is aware of
third party United States patents that contain issued claims that may cover the
proposed formulation for Bonefos(R) and the sale of Bonefos(R) for the treatment
of osteolysis or the modulation of hypercalcemia due to malignancy. If any
technologies, applications, patents or proprietary rights of others conflict
with the Company's activities or patents, the Company may be required to curtail
certain of its operations or seek to license disputed rights from others,
including the right to manufacture and sell Bonefos(R). There can be no
assurance that any such license will be available to the Company on commercially
reasonable terms, if at all. Any such conflict involving the Company, Berlex,
Leiras Oy or their respective affiliates may involve proceedings with patent
regulators or litigation seeking monetary damages and seeking to enjoin the
Company's commercial activities. The Company could incur substantial costs and
diversion of management resources in defending patent infringement claims,
obtaining patent licenses, engaging in interference proceedings or other
challenges to the related patent rights or intellectual property rights made by
others, or in bringing such proceedings or enforcing any patent rights against
others. Some of the Company's competitors have, or are affiliated with companies
having, substantially greater resources than the Company, and such competitors
may be able to sustain the costs of complex patent litigation to a greater
degree and for longer periods of time than the Company. Uncertainties resulting
from the initiation and continuation of any patent or related litigation could
have a material adverse effect on the Company's ability to compete in the
marketplace pending resolution of the disputed matters. The Company's inability
to obtain necessary licenses or its involvement in disputes or proceedings
concerning patent rights could have a material adverse effect on the business,
financial condition and results of operations of the Company.
As the biotechnology industry expands and more patents are issued, the risk
increases that the Company's potential products may give rise to claims that
they infringe the patents of others. Such other persons or entities could bring
legal actions against the Company claiming damages and seeking to enjoin
clinical testing, manufacturing and marketing of the affected products. Any such
litigation could result in substantial cost to the Company and a diversion of
effort by the Company's management and technical personnel. If any such actions
are successful, in addition to any potential liability for damages, the Company
could be required to obtain a license in order to continue to manufacture or
market the affected products. There can be no assurance that the Company would
prevail in any such action or that any license required under any such patent
would be made available on acceptable terms, if at all. Failure to obtain needed
patents, licenses or
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proprietary information held by others may have a material adverse effect on the
Company's business, financial condition and results of operations. In addition,
if the Company becomes involved in litigation, it could consume a substantial
portion of the Company's time and resources.
The Company also relies on trade secret protection for its confidential and
proprietary information. However, trade secrets are difficult to protect and
there can be no assurance that others will not independently develop
substantially equivalent proprietary information and techniques or otherwise
gain access to the Company's trade secrets or disclose such technology or that
the Company can meaningfully protect its rights to unpatented trade secrets. The
Company requires its consultants and advisors to execute a confidentiality
agreement upon the commencement of a consulting relationship with the Company,
and requires each of its key employees to enter into a similar confidentiality
agreement. Such agreements generally provide that all trade secrets and
inventions conceived by the individual and all confidential information
developed or made known to the individual during the term of the relationship
shall be the exclusive property of the Company and shall be kept confidential
and not disclosed to third parties except in specified circumstances. There can
be no assurance, however, that these agreements will provide meaningful
protection for the Company's proprietary information in the event of
unauthorized use or disclosure of such information.
To the extent that consultants, key employees or other third parties apply
technological information independently developed by them or by others to the
Company's proposed projects, disputes may arise as to the proprietary rights to
such information which may not be resolved in favor of the Company. Certain of
the Company's consultants are employed by or have consulting agreements with
third parties and any inventions discovered by any such individual generally
will not become property of the Company. The occurrence of one or more of the
foregoing events may have a material adverse effect on the Company's business,
financial condition and results of operations.
Dependence on Key Personnel and Consultants. The Company is dependent on
certain of its executive officers. Mr. Michael C. Walker, the Company's
co-founder, President and Chief Executive Officer, and Mr. Richard Onyett, the
Company's Senior Vice President -- Corporate Development, share management
responsibility for corporate operations, business and market development,
direction of clinical programs and contract negotiation. In addition, the
Company is highly dependent on the principal members of its scientific and
management staff, and the loss of any of their services might significantly
delay or prevent the achievement of research, development, or business
objectives. The Company does not maintain key-man life insurance with respect to
any of its employees; however, the Company will be required to use its best
efforts to obtain key man life insurance in the amount of $2 million for one or
more of the Company's principal executive officers, in accordance with the terms
of the Underwriting Agreement. There can be no assurance that the Company will
be able to obtain such insurance on commercially reasonable terms, if at all.
The Company does not have an employment agreement with any member of management
other than Michael C. Walker. See "Management -- Employment Agreements." The
loss of the services of any of these key personnel or other key employees of the
Company could have a material adverse effect on the Company. Competition for
qualified employees among pharmaceutical and biotechnology companies is intense,
and the loss of certain of such persons, or an inability to attract, retain and
motivate additional highly skilled employees, could materially and adversely
affect the Company's business, financial condition and results of operations.
There can be no assurance that the Company will be able to retain its existing
personnel or attract and retain additional qualified employees. In addition, the
Company may experience increased compensation costs in order to compete for
skilled employees. See "Management."
The Company is also dependent, in part, upon the continued contributions of
the lead investigators of the Company's sponsored research programs. The Company
also relies on consultants and advisors, including the members of its Scientific
Advisory Board, to assist the Company in formulating its research and
development strategy. Retaining and attracting qualified personnel, consultants
and advisors is critical to the Company's success. In addition, the Company's
scientific consultants and collaborators may have commitments to or consulting
or advisory agreements with other entities that may affect their ability to
contribute to the Company or may be competitive with the Company. See
"Management."
In order to pursue its product development and marketing and sales plans,
the Company will be required to hire additional qualified scientific personnel
to perform research and development, as well as personnel with
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expertise in clinical testing, government regulation, manufacturing, and
marketing and sales. The Company faces competition for qualified individuals
from numerous pharmaceutical and biotechnology companies, universities and other
research institutions. There can be no assurance that the Company will be able
to attract and retain such individuals on acceptable terms, if at all, and the
failure to do so could have a material adverse effect on the Company's business,
financial condition and results of operations.
Risk of Product Liability; Availability of Insurance. The use of the
Company's potential products in clinical trials and the marketing of any
pharmaceutical products may expose the Company to product liability claims. The
Company has obtained a level of liability insurance coverage that it deems
appropriate for its current stage of development. However, there can be no
assurance that the Company's present insurance coverage is adequate. Such
existing coverage will not be adequate as the Company further develops products,
and no assurance can be given that in the future adequate insurance coverage
will be available in sufficient amounts or at a reasonable cost. A successful
product liability claim could have a material adverse effect on the business and
financial condition of the Company.
Uncertainty Related to Health Care Reimbursement and Reform Measures. In
both United States and foreign markets, sales of the Company's proposed products
and the Company's success will depend in part on the availability of
reimbursement from third-party payors such as government health administration
authorities, private health insurers and other organizations. The levels of
revenues and profitability of pharmaceutical companies may be affected by the
continuing efforts of governmental and third-party payors to contain or reduce
the costs of health care. Over the past decade, the cost of health care has
risen significantly, and there have been numerous proposals by legislators,
regulators and third-party health care payors to curb these costs. Some of these
proposals have involved limitations on the amount of reimbursement for certain
products. There can be no assurance that similar Federal or state, or foreign,
health care legislation will not be adopted in the future, that any products
sought to be commercialized by the Company or its collaborators will be
considered cost-effective, or that adequate third-party insurance coverage will
be available for the Company to establish and maintain price levels sufficient
for realization of an appropriate return on its investment in product
development. Moreover, the existence or threat of cost control measures could
have an adverse effect on the willingness or ability of licensees to pursue
research and development programs related to the Company's product candidates.
The Company cannot predict the effect that private sector or governmental health
care reforms may have on its business, and there can be no assurance that any
such reforms will not have a material adverse effect on the Company's business,
financial condition and results of operations. In addition, in both the United
States and elsewhere, sales of prescription drugs are dependent in part on the
availability of reimbursement to the consumer from third-party payors, such as
government and private insurance plans. Third-party payors are increasingly
challenging the price and cost-effectiveness of medical products and services.
Significant uncertainty exists as to the reimbursement status of newly approved
health care products. There can be no assurance that the Company's proposed
products will be considered cost-effective or that adequate third-party
reimbursement will be available to enable the Company to maintain price levels
sufficient to realize an appropriate return on its investment in product
development. Legislation and regulations affecting the pricing of
pharmaceuticals may change before any of the Company's proposed products are
approved for marketing. Adoption of such legislation could further limit
reimbursement for medical products and services. As a result, the Company may
elect not to market future products in certain markets.
Lack of Manufacturing Experience; Reliance on Contract Manufacturers and
Suppliers. The Company does not have facilities to manufacture and produce its
compounds for preclinical, clinical or commercial purposes. Valstar(TM) has
never been manufactured for commercial purposes, and there can be no assurance
that Valstar(TM) can be manufactured at a cost or in quantities necessary to
make it commercially viable. The Company has put in place arrangements with
contract manufacturers to produce Valstar(TM). If the contract manufacturers are
unable to manufacture Valstar(TM) on acceptable terms, or encounter delays or
difficulties, the Company's preclinical and human clinical testing schedule
would be delayed, resulting in delay of the market introduction and subsequent
sales of Valstar(TM). This delay could have a material adverse effect on the
Company's business, financial condition and results of operations. Furthermore,
Anthra's contract manufacturers must supply all necessary documentation in
support of the Company's NDA, and any sNDAs, on a
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timely basis and must adhere to, among other requirements, cGMP enforced by the
FDA through its facilities inspection program, and such other requirements
imposed by other regulatory authorities. If these facilities cannot pass a
pre-approval plant inspection, the FDA approval of Valstar(TM) will not be
granted, and such failure to obtain approval would have a material adverse
effect on the Company's business, financial condition and results of operations.
Valstar(TM) is or has been manufactured in bulk powder form ("Valstar(TM)
Drug Substance") for the Company by Sicor S.p.A., a subsidiary of Gensia Sicor
Inc., in Rho (Milan), Italy and by Omnichem S.A. ("Omnichem"), which is also
owned by a larger parent company, in Louvain-la-Neuve, Belgium. Both of these
companies are independent of one another. The Company has in place a long-term
supply agreement with Genchem Pharma Ltd., a subsidiary of Gensia Sicor Inc.,
which agreement is guaranteed by Gensia Sicor Inc. (together with Sicor S.p.A.
and Genchem Pharma Ltd., "Gensia Sicor"). Valstar(TM) is manufactured in
finished dosage form in vials ("Valstar(TM) Drug Product") by Ben Venue
Laboratories, Inc. ("Ben Venue"). Ben Venue is owned by Boeheringer Ingelheim of
Germany. The Company has no written supply agreement with Ben Venue, although
the terms and conditions of such an agreement are being negotiated. There can be
no assurance that any of these suppliers can be compelled to make Valstar(TM) as
a Valstar(TM) Drug Substance or a Valstar(TM) Drug Product available to the
Company in the required quantities. There can be no assurance that the Company
will be able to identify and contract with alternative contract manufacturers
for its Valstar(TM) Drug Substance or Valstar(TM) Drug Product requirements in
the event that these suppliers are unable or unwilling to manufacture sufficient
quantities of Valstar(TM). The Company would incur significant costs and delays
to qualify an alternative manufacturer, which could have a material adverse
effect on the Company's business, financial condition and results of operations.
In addition, the Company's failure to meet its supply requirements pursuant to
certain of its licensing agreements could result in significant monetary
penalties being imposed on the Company. The availability and price of
Valstar(TM) may be subject to curtailment or change due to limitations that may
be imposed under governmental regulations, suppliers' allocations to meet demand
of other purchasers, interruptions in production by suppliers and market and
other events and conditions, which could have a material adverse effect on the
Company's business, financial condition and results of operations. See
"Business -- Products and Markets."
Bonefos(R) is manufactured by Leiras Oy of Helsinki, Finland, an affiliate
of Schering AG, Germany, for distribution in 56 countries outside of the United
States. Bonefos(R) has never been manufactured for commercial purposes for the
United States market, and there can be no assurance that Bonefos(R) can be
manufactured for sale and use in the United States at a cost or in quantities
necessary to make it commercially viable. If Anthra enters into the Bonefos
Agreements by exercising its option to do so under the Bonefos Option Agreement,
as it intends, Leiras Oy, pursuant to the Bonefos Agreements, undertakes to
supply the Company with Bonefos(R) for sale in the United States, subject to
certain conditions including the failure of Berlex to exercise its option to
acquire such rights. If Leiras Oy is then unable to manufacture Bonefos(R) on
acceptable terms or encounters delays or difficulties, the Company's human
clinical testing schedule would be delayed, resulting in delay of the market
introduction and subsequent loss of sales revenue (or, in the event Berlex
exercises its acquisition option, royalty revenue) for Anthra. This could have a
material adverse effect on the Company's business, financial condition and
results of operations. Furthermore, Leiras Oy would also have the obligation to
supply all necessary documentation in support of the Company's Bonefos(R) NDA
and sNDAs on a timely basis and adhere to cGMP regulations enforced by the FDA
through its facilities inspection program. If these facilities cannot pass a
pre-approval inspection, the FDA approval of Bonefos(R) would not be granted.
Such failure could have a material adverse effect on the Company's business,
financial condition and results of operations.
Hazardous Materials. The Company's research and development involves the
controlled use of hazardous, controlled and radioactive materials by certain of
its contractors. In addition, the Company's product Valstar(TM) in its final
form is a hazardous and a controlled substance with risks of contamination and
injury unless utilized in the prescribed method. The Company and its contractors
are subject to Federal, state, local and foreign laws and regulations governing
the use, manufacture, storage, handling and disposal of such materials and
certain waste products therefrom. Although the Company believes that the safety
procedures of the Company and its contractors for handling and disposing of such
materials comply with the standards
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prescribed by such laws and regulations, the risk of accidental contamination or
injury from these materials cannot be completely eliminated. In the event of
such an accident, the Company could be held liable for any damages that result
and any such liability could have a material adverse effect on the Company.
Risks Associated with International Operations and Foreign Currency
Fluctuations. The Company's international operations are anticipated to
comprise a substantial percentage of the Company's net revenue in the future
and, accordingly, the Company is subject to risks associated with international
operations. Such risks include managing a multinational organization,
fluctuations in currency exchange rates, the burden of complying with
international laws and other regulatory and product certification requirements
and changes in such laws and requirements, tariffs and other trade barriers,
import and export controls, restrictions on the repatriation of funds,
inflationary conditions, staffing, employment and severance issues, political
and economic instability and longer payment cycles in certain countries. The
inability to effectively manage these and other risks could adversely affect the
Company's business, financial condition and results of operations.
The Company has a clinical development facility in the United Kingdom
operated by Anthra UK, the operating expenses of which are also subject to the
effects of fluctuations in currency exchange rates. The Company generally does
not engage in hedging transactions which could partially offset the effects of
fluctuations in currency exchange rates. Additional financial exposure may
result due to the timing of transactions and movement of exchange rates. See
"Business -- Products and Markets."
Management of Growth. The Company has recently experienced, and expects to
continue to experience, significant growth in the number of its employees and
the scope of its operations. This growth has placed, and may continue to place,
a significant strain on the Company's management and operations. Should the
Company acquire any additional products by the end of 1999, the Company may
experience a large and immediate growth in its employees and operations. The
Company's ability to manage effectively such growth will depend upon its ability
to broaden its management team and its ability to attract, hire and retain
skilled employees. The Company's success will also depend on the ability of its
officers and key employees to continue to implement and improve its operational,
management information and financial control systems and to expand, train and
manage its employee base. These demands are expected to require the addition of
new management personnel and development of additional expertise to existing
management personnel. In addition, if Anthra reaches the point where its
activities require additional expertise in clinical testing, in obtaining
regulatory approvals, and in production and marketing, there will be increased
demands on Anthra's resources and infrastructure. There can be no assurance that
the Company will be able to effectively manage the expansion of its operations
or that its systems, procedures or controls will be adequate to support the
Company's products or proprietary technology. There can be no assurance that the
Company will be successful in adding technical personnel as needed to meet the
staffing requirements of the Company's current strategic collaborations or any
additional collaborative relationships into which the Company may enter. Any
such inability to manage growth could have a material adverse effect on the
Company's business, financial condition and results of operations.
Risks Associated With Potential Acquisitions. The Company may acquire or
make substantial investments in complementary businesses, technologies or
products in the future. Any such acquisition or investment would entail various
risks, including the difficulty of integrating the technologies, operations and
personnel of the acquired business, technology or product, the potential
disruption of the Company's ongoing business and, generally, the potential
inability of the Company to obtain the desired financial and strategic benefits
from the acquisition or investment. These factors could have a material adverse
effect on the Company's business, financial condition and results of operations.
Future acquisitions and investments by the Company could also result in
substantial cash expenditures, potentially dilutive issuances of equity
securities, the incurrence of additional debt and contingent liabilities, and
amortization expenses related to goodwill and other intangible assets, which
could adversely affect the Company's business, financial condition and results
of operations.
Potential Adverse Market Impact of Shares Eligible for Future Sale;
Registration Rights. Sales of a substantial number of shares of the Company's
securities in the public market following the Offering could have an adverse
effect on the price of the Company's securities. Upon completion of the
Offering, the
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Company will have 6,855,183 shares of Common Stock outstanding (7,155,183 if the
Underwriter's over-allotment option is exercised in full). Of these shares, the
2,000,000 shares included in the Units sold in the Offering will be freely
tradable without restriction or further registration under the Securities Act of
1933, as amended (the "Securities Act"). However, the shares of Common Stock
included in the Units will not be traded on the American Stock Exchange until
the Separation Date. The remaining 4,855,183 shares of Common Stock are
"restricted securities" as that term is defined under Rule 144 under the
Securities Act, and were issued and sold by the Company in reliance on
exemptions from registration under the Securities Act. These restricted shares
may not be sold in the public market unless they are registered under the
Securities Act or are sold pursuant to an exemption from registration, such as
Rule 144, 144(k) or 701. Beginning 90 days after the date of this Prospectus,
approximately 4,855,183 restricted securities will become eligible for sale in
the public market pursuant to Rule 144 and Rule 701 under the Securities Act.
Additional shares of Common Stock will become eligible for resale in the public
market at subsequent dates, including after the Separation Date, including the
shares of Common Stock issuable upon the exercise of the Warrants, the
Underwriter's Warrant and the Warrants issuable thereunder.
The Company has represented to the Underwriter that it will obtain from
substantially all of the Company's stockholders certain lock-up agreements,
pursuant to which such stockholder will agree not, directly or indirectly, sell,
offer for sale, grant any option for the sale of or otherwise dispose of their
shares for a period commencing on the date of this Prospectus and ending on the
last day of the 13th month after the closing date of the Offering without the
prior written consent of the Underwriter. There can be no assurance that the
Company will be able to obtain such agreements from the stockholders. The
Company has agreed with the Underwriter that it will not file any registration
statement to register any of the securities granted or issued under the
Company's 1990 Stock Plan, as amended, during the 13 months following the
closing date of the Offering without the Underwriter's prior written consent.
See "Management -- 1990 Stock Plan" and "Shares Eligible for Future Sale."
It is a condition to the Offering that the Company obtain the agreement of
all holders of Preferred Stock to convert their shares of Preferred Stock to
Common Stock upon the consummation of the Offering.
Upon completion of the Offering, holders of 4,554,683 shares of the
Company's Common Stock will be entitled to certain rights with respect to
registration of such shares for offer or sale to the public. In addition, the
Company intends to register 1,700,000 shares of Common Stock reserved for
issuance under its 1990 Stock Plan as amended, following the date of this
Prospectus. See "Management -- Summary of Executive Compensation," "Principal
Stockholders" and "Shares Eligible for Future Sale."
The Warrants are exercisable on the Separation Date. The Underwriter's
Warrant is exercisable after the one-year period following the date hereof. The
exercise of the Warrants and the Underwriter's Warrant (and the Warrants
included as part thereof) will dilute the percentage ownership of the Company's
stockholders, and any sales in the public market of securities underlying the
Underwriter's Warrant and Warrants may adversely affect prevailing market
prices. Moreover, the terms upon which the Company will be able to obtain
additional equity capital may be adversely affected since the holders of the
Underwriter's Warrant and Warrants can be expected to exercise them at a time
when the Company would, in all likelihood, be able to obtain any needed capital
on terms more favorable to the Company than those provided in the Underwriter's
Warrant and Warrants.
Lack of Current Specific Plans for Unallocated Offering Proceeds. The
principal purposes of the Offering are to increase the Company's capitalization
and financial flexibility and to expand the Company's current corporate
facilities and infrastructure. The Company currently does not have specific
plans for all of the net proceeds from the Offering. The Company expects to use
such proceeds for general corporate purposes, including working capital, product
development, capital expenditures and possible acquisitions. The amounts
expended for each purpose and the timing of such expenditures may vary depending
upon numerous factors. Consequently, the Company will have broad discretion in
determining the amount and timing of expenditures and in using the unallocated
proceeds of the Offering, and there can be no assurance that the Company will
use such discretion effectively or in a manner that will not result in a
material adverse effect on the Company's business, financial condition and
results of operation. See "Use of Proceeds."
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Absence of Prior Trading Market; Possible Volatility of Stock Price. Prior
to the Offering, there has been no public market for the Units, the Common Stock
or the Warrants and there is no assurance that an active market will develop or
be sustained after the Offering or the Separation Date, as the case may be.
Until the Separation Date, the Common Stock and the Warrants will not be
included for quotation on the American Stock Exchange. The initial public
offering price of the Units, and the exercise price and other terms of the
Warrants, will be determined through negotiations among the Company and the
Underwriter and may bear no relationship to the price at which the Units, the
Common Stock or the Warrants will trade upon completion of the Offering or the
Separation Date, as the case may be. See "Underwriting." It is likely that the
market price of the securities offered hereby, like that of the capital stock of
many other pharmaceutical companies at a similar stage of development, will be
highly volatile. Factors such as the results of preclinical studies and clinical
trials by the Company or its competitors, announcements of technological
innovations or new commercial therapeutic products by the Company or its
competitors, governmental regulation, changes in reimbursement policies,
healthcare legislation, developments in patent or other proprietary rights,
developments in the Company's relationships with future collaborative partners,
if any, public concern as to the safety and efficacy of drugs developed by the
Company, fluctuations in the Company's operating results, and general market
conditions may have a significant impact on the market price of the securities
offered hereby.
No assurance can be given that the market price of the Company's Common
Stock will exceed the exercise price of the Warrants at any time during their
exercise period.
Pursuant to the terms of the Company's Development Agreement with Medeva
(the "Medeva Agreement"), in the event that neither of two NDA approvals for
Valstar(TM) has been obtained by the Company by December 31, 2002, Medeva has
the right to require the Company to issue such number of shares of Common Stock
equal to 20% of the issued and outstanding voting equity securities of the
Company outstanding at the time of the exercise of such right. See
"Business -- Products and Markets."
Dilution. The initial public offering price is substantially higher than
the tangible book value per share of the Common Stock. Investors purchasing
shares of Common Stock included in the Units will therefore suffer immediate and
substantial dilution. Assuming the Company is successful in obtaining from all
of the holders of Preferred Stock agreements to convert all of their shares of
Preferred Stock into the same number of shares of Common Stock upon the closing
of the Offering and after giving effect to the resultant Preferred Stock
Conversion and the sale by the Company of the 2,000,000 Units offered hereby at
an assumed initial public offering price of $5.00 per Unit (and, for purposes of
this calculation, ascribing no value to the Warrants) and the receipt by the
Company of the estimated net proceeds therefrom, investors in this Offering will
experience immediate dilution of $4.77 per share. If the Company does not obtain
such conversion agreements, after the sale by the Company of the 2,000,000 Units
offered hereby at an assumed initial public offering price of $5.00 per Unit
(and, for purposes of this calculation, ascribing no value to the Warrants) and
the receipt by the Company of the estimated net proceeds therefrom, investors in
this Offering will experience immediate dilution of $8.28 per share. See
"Dilution."
Redemption of Warrants. The Warrants offered hereby are redeemable, in
whole or in part, at a price of $0.10 per Warrant, commencing 15 months from the
date of this Prospectus upon at least 30 days' prior written notice of such
redemption to the holders of the Warrants, provided that (i) the last sales
price of the Common Stock as reported on the American Stock Exchange (or, if not
then so listed, as otherwise provided in the Unit and Warrant Agreement between
the Company and American Stock Transfer & Trust Company (the "Warrant
Agreement")) has been at least $9.00 per share for 20 consecutive trading days
ending within 10 days of the date on which the notice of redemption is given and
(iii) there is a current registration statement covering the resale of the
underlying shares of Common Stock. The Company has agreed to use all
commercially reasonable efforts to either (i) keep this Registration Statement
effective through the Effective Deadline (as defined in the Warrant Agreement)
or until such time as no Warrants are outstanding or (ii) cause a registration
statement with respect to the shares of Common Stock underlying the Warrants to
be effective from the Separation Date through the Effective Deadline or until
such time as no Warrants remain outstanding. Holders of the Warrants may
exercise their Warrants after the Separation Date until the earlier to occur of
(i) the fifth anniversary of the effective date of the Registration Statement of
which this Prospectus forms a part and (ii) the close of the business day
immediately preceding the date fixed for redemption. Notice of redemption of the
Warrants could force holders to exercise the Warrants and pay the
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exercise price therefor at time when it may be disadvantageous for them to do
so, sell the Warrants at the current market price when they might otherwise wish
to hold the Warrants or accept the redemption price which is likely to be
substantially less than the market value of the Warrants at the time of
redemption. See "Description of Securities -- Warrants."
Current Prospectus and State Blue Sky Registration Required to Exercise
Warrants. Holders of the Warrants will be able to sell the shares of Common
Stock issuable upon exercise of the Warrants only if a current registration
statement relating to such shares is then in effect and only if the shares are
qualified for sale under the securities laws of the applicable state or states.
The Company has undertaken and intends to file and keep current a registration
statement covering the shares of Common Stock issuable upon exercise of the
Warrants, but there can be no assurance that the Company will be able to do so.
Although the Company intends to seek to qualify such shares of Common Stock for
sale in those states where the Units are to be offered, there is no assurance
that such qualification will occur. The Warrants may be deprived of any value if
the current registration statement covering the shares underlying the Warrants
is not effective and available or such underlying shares are not or cannot be
registered in the applicable states. See "Description of
Securities -- Warrants."
Control by Existing Stockholders; Anti-Takeover Provisions. Upon the
closing of the Offering, the Company's Directors and executive officers will, in
the aggregate, beneficially own approximately 15.3% of Anthra's outstanding
shares of Common Stock (approximately 14.7% if the Underwriter's over-allotment
option is exercised in full). See "Principal Stockholders." Accordingly, these
stockholders, acting together, will be able to control many matters requiring
approval by the stockholders of the Company, including the election of
Directors. Moreover, the Company anticipates that its Amended and Restated
Certificate of Incorporation, as amended, and as in effect on the consummation
of the Offering (the "Amended Certificate of Incorporation"), will not provide
for cumulative voting with respect to the election of Directors. Consequently,
the present Directors and executive officers would be able to exercise
substantial influence over the election of the members of the Board of
Directors. Such concentration of ownership could have an adverse effect on the
price of the securities offered hereby or have the effect of delaying or
preventing a change in control of the Company. In addition, certain provisions
of Delaware law and the Amended Certificate of Incorporation could have the
effect of making it more difficult for a third party to acquire, or of
discouraging a third party from attempting to acquire, control of Anthra. Such
provisions could limit the price that certain investors might be willing to pay
in the future for the securities offered hereby. These provisions of Delaware
law and the Amended Certificate of Incorporation may also have the effect of
discouraging or preventing certain types of transactions involving an actual or
threatened change of control of the Company (including unsolicited takeover
attempts), even though such transactions may offer the Company's stockholders
the opportunity to sell their stock at a price above the prevailing market
price. One of the provisions in the Amended Certificate of Incorporation allows
the Company to issue preferred stock without any vote or further action by the
stockholders. These provisions may make it more difficult for stockholders to
take certain corporate actions and could have the effect of delaying or
preventing a change in control of the Company. See "Business," "Management,"
"Principal Stockholders," and "Description of Capital Stock -- Preferred Stock"
and "-- Anti-Takeover Law."
Year 2000 Issues. In the Year 2000, many existing computer programs that
use only two digits (rather than four) to identify a year in the date field
could fail or create erroneous results if not corrected. This computer program
flaw is expected to affect virtually all companies and organizations. The
Company believes that its internal systems are Year 2000 compliant. However, the
failure of third parties with which the Company does business to remediate their
Year 2000 problems could have a material adverse impact on the operations of the
Company.
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USE OF PROCEEDS
The 2,000,000 Units offered hereby are comprised of 2,000,000 shares of
Common Stock and 2,000,000 Warrants. The net proceeds to the Company from the
sale of the 2,000,000 Units offered hereby, after deducting underwriting
discounts and commissions and estimated offering expenses, are estimated to be
approximately $7.8 million ($9.1 million if the Underwriter's over-allotment
option is exercised in full) based upon an assumed initial public offering price
of $5.00 per Unit. The Company anticipates that such net proceeds, together with
its other available cash and cash equivalents, will be used as follows: (i)
approximately $3.3 million for payments for rights to Bonefos(R); (ii)
approximately $100,000 to the Underwriter as a prepayment for a three year
consulting agreement (the "Consulting Agreement"); and (iii) the balance for
development of its products (including obtaining regulatory approvals for
Valstar(TM) and Bonefos(R)), potential additional product acquisitions and
general corporate purposes. See "Underwriting." While the Company engages from
time to time in discussions with respect to potential acquisitions, the Company
has no current plans, commitments or agreements with respect to any such
acquisitions as of the date of this Prospectus. Pending such uses, the Company
intends to invest the net proceeds from the Offering in United States government
securities and investment-grade, interest-bearing instruments.
The foregoing represents the Company's present intentions with respect to
the allocation of proceeds of the Offering based upon its present plans and
business conditions. The occurrence of certain unforeseen events or changed
business conditions, however, could result in the application of the proceeds of
the Offering in a manner other than as described in this Prospectus. See "Risk
Factors -- Lack of Current Specific Plans for Unallocated Offering Proceeds."
DIVIDEND POLICY
The Company has never paid any cash dividends on its Common Stock. The
Company currently intends to retain all future earnings, if any, to finance the
operations and expansion of the Company's business and therefore does not
anticipate paying cash dividends in the foreseeable future. In addition, the
Company's ability to pay dividends may be affected by financing arrangements
which the Company may enter into in the future.
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CAPITALIZATION
The following table sets forth the capitalization of the Company as of June
30, 1998, (i) on an actual basis, (ii) on a pro forma basis to reflect an
assumed Preferred Stock Conversion and (iii) on a pro forma as adjusted basis to
give effect to the Preferred Stock Conversion and the sale by the Company of the
2,000,000 Units offered hereby, at an assumed initial public offering price of
$5.00 per Unit, less underwriting discounts and commissions and estimated
offering expenses payable by the Company, and the application of the estimated
net proceeds therefrom as set forth under "Use of Proceeds." This table should
be read in conjunction with "Management's Discussion and Analysis of Financial
Condition and Results of Operations" and the Consolidated Financial Statements
and Notes thereto appearing elsewhere in this Prospectus.
AS OF JUNE 30, 1998
--------------------------------------------
PRO FORMA
ACTUAL PRO FORMA(3) AS ADJUSTED(3)
-------- -------------- --------------
(UNAUDITED) (UNAUDITED)
(IN THOUSANDS)
Contingent stock obligation(1)....................... $ 8,000 $ 8,000 $ 8,000
-------- -------- --------
Mandatorily redeemable convertible preferred stock
(Series A, B and C Convertible Preferred Stock) at
redemption value (which includes accreted dividends
of $3,423,057); $0.01 par value: 3,150,588 shares
authorized, issued and outstanding, actual (none
issued and outstanding on a pro forma and pro forma
as adjusted basis)................................. 11,623 -- --
-------- -------- --------
Stockholders' equity (deficit):
Convertible preferred stock (Series D Convertible
Preferred Stock); $0.01 par value: 639,095
shares authorized, issued and outstanding,
actual (none issued and outstanding on a pro
forma and pro forma as adjusted basis).......... 6 -- --
Common stock, $0.01 par value: 15,000,000 shares
authorized 1,065,500, 4,855,183 and 6,855,183
shares issued and outstanding on an actual, pro
forma and pro forma as adjusted basis,
respectively)(2)................................ 11 49 69
Additional paid-in capital......................... 8,675 20,266 28,046
Deferred compensation.............................. (925) (925) (925)
Deficit accumulated during the development stage... (25,616) (25,616) (25,616)
-------- -------- --------
Total stockholders' equity (deficit)................. (17,849) (6,226) 1,574
-------- -------- --------
Total capitalization................................. $ 1,774 $ 1,774 $ 9,574
======== ======== ========
- ---------------
(1) See Note 5 of Notes to Consolidated Financial Statements.
(2) Does not include (a) 1,535,487 shares of Common Stock issuable upon exercise
of stock options outstanding at June 30, 1998, with a weighted average
exercise price of $3.01 per share, of which options to purchase 509,787
shares of Common Stock were then exercisable (see "Management"), (options to
purchase 199,532 shares of Common Stock have been cancelled after June 30,
1998), (b) certain stock options to purchase Common Stock or Series D
Convertible Preferred Stock which may be granted to Nycomed pursuant to the
Nycomed Agreement (see "Business -- Products and Market -- Valstar(TM):
Licensing Agreements"), (c) 2,000,000 shares of Common Stock issuable upon
exercise of the Warrants, and (d) 400,000 shares of Common Stock issuable on
the exercise of the Units underlying the Underwriter's Warrant and the
Warrants underlying such Units.
(3) The Company is currently attempting to obtain agreements from all of the
holders of Preferred Stock to convert all of their shares of Preferred Stock
into the same number of shares of Common Stock upon the closing of the
Offering. The amounts presented assume that the Company obtains the
conversion agreements from each holder of Preferred Stock and the resultant
conversion of all issued and outstanding shares of Preferred Stock into
3,789,683 shares of Common Stock effective upon the closing of the Offering.
If the Company does not obtain such conversion agreements, the pro forma as
adjusted stockholders' equity (deficit) would be $(10,049,000), convertible
preferred stock would be $6,000, common stock would be $31,000, additional
paid-in capital would be $16,455,000 and mandatorily redeemable convertible
preferred stock would be $11,623,000.
23
26
DILUTION
The pro forma net deficit in tangible book value of the Company as of June
30, 1998, was $(7,108,000), or $(1.46) per share of Common Stock. Pro forma net
deficit in tangible book value per share represents the Company's total tangible
assets less total liabilities, divided by 4,855,183 shares of Common Stock
outstanding (assuming the Company is successful in obtaining from all of the
holders of Preferred Stock agreements to convert all of their shares of
Preferred Stock into the same number of shares of Common Stock upon the closing
of the Offering and after reflecting the resultant Preferred Stock Conversion).
After reflecting the resultant Preferred Stock Conversion and the sale by the
Company of 2,000,000 Units in this Offering at the initial offering price
(attributing no value to the Warrants) and after deducting the underwriting
discounts and commissions and estimated offering expenses, the pro forma net
tangible book value of the Company as of June 30, 1998 would have been
$1,574,000, or $0.23 per share. This amount represents an immediate increase in
pro forma net tangible book value of $1.69 per share to existing stockholders
and the immediate dilution in net tangible book value of $4.77 per share to new
investors purchasing shares of Common Stock included in the Units in the
Offering. Dilution per share to new investors represents the difference between
the pro forma net tangible book value per share of Common Stock immediately
after completion of the Offering and the amount per share paid by purchasers of
shares of Common Stock included in the Units in the Offering. The following
table illustrates the per share dilution:
Initial public offering price per share..................... $ 5.00
Pro forma net deficit in tangible book value per share at
June 30, 1998.......................................... $(1.46)
Increase per share attributable to new investors.......... 1.69
------
Pro forma net tangible book value per share after the
Offering.................................................. 0.23
------
Dilution per share to new investors......................... $ 4.77
======
The following table summarizes, on a pro forma basis as of June 30, 1998,
the differences between the existing stockholders (assuming the Company is
successful in obtaining from all of the holders of Preferred Stock agreements to
convert all of their shares of Preferred Stock into the same number of shares of
Common Stock upon the closing of the Offering and after reflecting the resultant
Preferred Stock Conversion) and new investors with respect to the number of
shares of Common Stock purchased from the Company, the total consideration paid
to the Company and the average price per share paid, at the assumed initial
public offering price of $5.00 per Unit (attributing no value to the Warrants)
before deducting the underwriting discounts and commissions and estimated
offering expenses payable by the Company.
TOTAL
SHARES PURCHASED CONSIDERATION PAID
-------------------- ---------------------- AVERAGE
NUMBER PERCENT AMOUNT PERCENT PRICE PER SHARE
--------- ------- ----------- ------- ---------------
Existing stockholders..... 4,855,183 71% $18,852,750 65% $ 3.88
New investors............. 2,000,000 29% $10,000,000 35% $ 5.00
--------- --- ----------- ---
Total..................... 6,855,183 100% $28,852,750 100%
========= === =========== ===
The Company is currently attempting to obtain agreements from all of the
holders of Preferred Stock to convert all of their shares of Preferred Stock to
the same number of shares of Common Stock upon the closing of the Offering. If
the Company does not receive such conversion agreements, the Preferred Stock
Conversion will not occur and the actual net deficit in tangible book value of
the Company as of June 30, 1998 is $(18,731,273), the pro forma net deficit in
tangible book value of the Company as of June 30, 1998 after reflecting the sale
by the Company of 2,000,000 Units in this Offering at the initial offering price
(attributing
24
27
no value to the Warrants) and after deducting the underwriting discounts and
commissions and estimated offering costs would be $(10,049,493) and the per
share dilution would be as follows:
Initial public offering price per share..................... $ 5.00
Net deficit in tangible book value per share at June 30,
1998................................................... $(17.58)
Increase per share attributable to new investors.......... 14.30
------- ------
Net deficit in tangible book value per share after the
Offering.................................................. (3.28)
------
Dilution per share to new investors......................... $ 8.28
======
If the Company does not receive the conversion agreements, the following
table summarizes, on a pro forma basis as of June 30, 1998, the differences
between the existing stockholders and new investors with respect to the number
of shares of Common Stock purchased from the Company, the total consideration
paid to the Company and the average price per share paid, at the assumed initial
public offering price of $5.00 per Unit (attributing no value to the Warrants)
before deducting the underwriting discounts and commissions and estimated
offering expenses payable by the Company.
TOTAL
SHARES PURCHASED CONSIDERATION PAID
-------------------- ---------------------- AVERAGE
NUMBER PERCENT AMOUNT PERCENT PRICE PER SHARE
--------- ------- ----------- ------- ---------------
Existing stockholders..... 1,065,500 35% $ 2,403,100 19% $2.26
New investors............. 2,000,000 65% $10,000,000 81% $5.00
--------- --- ----------- ---
Total..................... 3,065,500 100% $12,403,100 100%
========= === =========== ===
The foregoing computations do not include (a) 1,535,487 shares of Common
Stock issuable upon exercise of stock options outstanding at June 30, 1998, with
a weighted average exercise price of $3.01 per share, of which options to
purchase 509,757 shares of Common Stock were then exercisable (see
"Capitalization" and "Management") (options to purchase 199,532 shares of Common
Stock have been cancelled after June 30, 1998), (b) certain stock options to
purchase Common Stock or Series D Convertible Preferred Stock which may be
granted to Nycomed pursuant to the Nycomed Agreement (see "Business -- Products
and Market -- Valstar(TM): Licensing Agreements"), (c) 2,000,000 shares of
Common Stock issuable upon exercise of the Warrants, (d) 400,000 shares of
Common Stock issuable on the exercise of the Units underlying the Underwriter's
Warrant and the Warrants underlying such Units, and (e) Common Stock which may
be issuable to Medeva for 20% of the then issued and outstanding voting equity
securities if neither of two certain regulatory approvals is received by
December 31, 2002, pursuant to the Medeva Agreement (see "Business Products and
Market -- Valstar(TM): Licensing Agreements").
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28
SELECTED CONSOLIDATED FINANCIAL DATA
(IN THOUSANDS, EXCEPT PER SHARE DATA)
The selected consolidated financial data for each of the years in the three
year period ended June 30, 1998 and as of June 30, 1997 and 1998 have been
derived from consolidated financial statements of the Company which have been
audited by KPMG Peat Marwick LLP, independent certified public accountants,
included elsewhere in this Prospectus. The selected financial data for the years
ended June 30, 1994 and 1995, for the period from June 25, 1985 (inception) to
June 30, 1998 and as of June 30, 1994, 1995 and 1996 have been derived from
unaudited (except for the year ended June 30, 1995 and as of June 30, 1995 and
1996, which have been audited) financial statements of the Company which are not
included in this Prospectus. The selected consolidated financial data set forth
below are qualified in their entirety by, and should be read in conjunction
with, "Management's Discussion and Analysis of Financial Condition and Results
of Operations," the Consolidated Financial Statements and Notes thereto and the
other financial information included elsewhere in this Prospectus. The
Independent Auditors' Report covering the June 30, 1998 consolidated financial
statements included elsewhere herein, contains an explanatory paragraph which
states that the Company's recurring losses from operations, net capital
deficiency and insufficient working capital raise substantial doubt about the
Company's ability to continue as a going concern. The consolidated financial
statements do not include any adjustments that might result from the outcome of
that uncertainty.
FOR THE PERIOD FROM
YEARS ENDED JUNE 30, JUNE 25, 1985
----------------------------------------------------------- (INCEPTION) TO
1994 1995 1996 1997 1998 JUNE 30, 1998
----------- ----------- ------- --------- --------- -------------------
(UNAUDITED) (UNAUDITED)
CONSOLIDATED STATEMENT OF
OPERATIONS DATA:
Revenue....................................... $ -- $ -- $ 2,171 $ 1,688 -- $ 3,859
Operating Expenses:
Research and development.................... 2,418 2,591 3,649 6,610 9,212 26,824
General and administrative.................. 71 121 523 682 1,894 3,505
------- ----------- ------- --------- --------- --------
Total operating expenses...................... 2,489 2,712 4,172 7,292 11,106 30,329
Other income (expense)........................ 37 94 111 139 359 854
------- ----------- ------- --------- --------- --------
Net loss...................................... $(2,452) $ (2,618) $(1,890) $ (5,465) $ (10,747) $(25,616)
======= =========== ======= ========= ========= ========
Net loss allocable to common stockholders..... $(2,874) $ (3,271) $(2,543) $ (6,118) $ (11,400) $(29,039)
======= =========== ======= ========= ========= ========
Basic and diluted net loss per share allocable
to common stockholders(1)................... $ (4.02) $ (4.24) $ (3.01) $ (5.79) $ (10.70)
Shares used in computing basic and diluted net
loss per share allocable to common
stockholders(1)............................. 716 771 844 1,057 1,066
AS OF JUNE 30,
---------------------------------------------------------
1994 1995 1996 1997 1998
----------- ------- ------- -------- --------
(UNAUDITED)
CONSOLIDATED BALANCE SHEET DATA:
Cash and cash equivalents .................................. $ 3,391 $ 1,273 $ 1,713 $ 795 $ 2,912
Working capital (deficit)................................... 3,420 827 1,908 (598) 635
Total assets................................................ 3,580 1,322 2,732 915 4,100
Contingent stock obligation................................. -- -- -- -- 8,000
Mandatorily redeemable convertible preferred stock.......... 9,011 9,664 10,317 10,970 11,623
Convertible preferred stock................................. -- -- 3 3 6
Deficit accumulated during the developmental stage.......... (4,897) (7,515) (9,404) (14,869) (25,616)
Total stockholders' deficit................................. (5,558) (8,795) (8,330) (11,486) (17,849)
- ---------------
(1) See Note 2 of Notes to Consolidated Financial Statements.
26
29
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of financial condition and results of
operations of the Company should be read in conjunction with the Consolidated
Financial Statements and the Notes thereto appearing elsewhere in this
Prospectus. This Prospectus, including the following discussion, contains
forward-looking statements that involve risks and uncertainties. The Company's
actual results may differ significantly from the results discussed in such
forward-looking statements. Factors that could cause or contribute to such
differences include, but are not limited to, those discussed in "Risk Factors"
and elsewhere in this Prospectus. Unless otherwise indicated, all references to
years in the "Management's Discussion and Analysis of Financial Condition and
Results of Operations" refer to the fiscal years of the Company ended June 30.
OVERVIEW
Anthra is a specialized pharmaceutical company engaged in managing clinical
development and obtaining approval of NDAs and sNDAs for a portfolio of its
proprietary cancer drugs. The Company's current drug candidates are for the
treatment of patients with superficial cancer of the bladder, ovarian and
prostatic cancer, and complications from metastatic cancer (hypercalcemia and
lytic bone disease). The Company's strategy is to develop only late stage drug
candidates, thereby improving the likelihood of successfully obtaining NDA/sNDA
and equivalent foreign approvals. The Company directs its search for oncology
drug candidates toward selected large pharmaceutical companies, because of the
difficulty many of these companies have experienced in managing oncology
projects, and at biotechnology and early stage discovery companies that lack
clinical and regulatory proficiency. To maximize the return on its investment in
each drug, Anthra seeks approvals for multiple disease indications for each
product and directly manages both its United States and foreign clinical
programs and regulatory submissions. At the present time, Anthra has entered
into four marketing agreements with major multinational drug companies for which
it has received certain initial payments and expects significant additional
payments in the form of milestone fees and royalty and supply payments.
To date, the Company has not received any revenue from the sale of
products, and no product candidate of the Company has been approved. The Company
has received a non-refundable $8 million payment pursuant to the Medeva
Agreement, which has been recorded as a contingent stock obligation at June 30,
1998, an additional $2.1 million payment received in September 1998 for having
achieved a certain milestone under the Medeva Agreement, and a $200,000 license
fee from Almirall pursuant to the Exclusive License Agreement, dated as of April
17, 1997, between Anthra and Almirall (f/k/a Prodesfarma, S.A.) (the "Almirall
Agreement"). To date the Company's primary source of capital has been the sale
of Preferred Stock, the payment from Medeva, license fees, and research and
development funding from its Collaborative Partners in connection with joint
development and licensing agreements with the Company, including the
aforementioned payments. As of June 30, 1998, the Company's accumulated deficit
was $25.6 million and its cash and cash equivalents was $2.9 million. While the
Company believes that Valstar(TM) will be approved for marketing for the ODAC
Recommended Indication by the end of calendar 1998, there can be no assurance
that the Company's products will be approved for marketing, that the Company
will attain profitability or, if profitability is achieved, that the Company
will remain profitable on a quarterly or annual basis in the future.
TWELVE MONTHS ENDED JUNE 30, 1998 AND 1997
The Company recognized $1.7 million in revenue for the year ended June 30,
1997, $200,000 of which was in connection with the Almirall Agreement in 1997,
$1.3 million in connection with the conversion of the Development and License
Agreement with Schering AG, Germany (f/k/a Schering AG) (the "Development
Agreement") into the Termination, Settlement and Investment Agreement with
Schering AG, Germany in July 1996 (the "Support Agreement") and $200,000 related
to research and development performed under the Development Agreement. No such
revenue was recognized for the year ended June 30, 1998. The Development
Agreement was converted into the Support Agreement based on the mutual agreement
between the companies as to how best to proceed with the development of
Valstar(TM). The impact of this conversion was that Schering AG, Germany was no
longer obligated to (i) reimburse the Company for future research and
27
30
development, (ii) make potential license payments of up to $3 million and (iii)
pay potential future royalties. The Company is also obligated to make potential
royalty payments to Schering AG, Germany on Valstar(TM) sales.
Research and development expenses increased 39% from $6.6 million in 1997
to $9.2 million in 1998. This increase was largely due to increased levels of
activity with respect to the continued development of Valstar(TM). These
activities included a staff increase of nine employees, increased patient
enrollment in clinical studies, filing of the NDA for the Valstar(TM)
superficial bladder cancer indication and preparation for the June 1, 1998 ODAC
meeting.
General and administrative expenses increased from $682,000 in 1997 to $1.9
million in 1998, primarily as a result of increased business development and
expenses related to worldwide development and licensing agreements.
Other income (expense) increased from $139,000 in 1997 to $359,000 in 1998.
This increase reflects a significantly higher cash and cash equivalents balance
resulting from the following three transactions: the purchase by Nycomed, in
October 1997, of 300,000 shares of Series D Convertible Preferred Stock for $4.5
million; the purchase by Almirall, in April 1997, of 67,819 shares of Series D
Convertible Preferred Stock for $750,000 and the $8.0 million payment from
Medeva in July 1997 pursuant to the terms of the Medeva Agreement.
Net loss increased from $5.5 million in 1997 to $10.7 million in 1998. This
increase is primarily due to the increase in research and development spending,
business development and the discontinuation of development revenue following
the conversion of the Development Agreement to the Support Agreement in July
1996.
TWELVE MONTHS ENDED JUNE 30, 1997 AND 1996
The Company recognized $2.2 million and $1.7 million in revenue for the
years ended June 30, 1996 and 1997, respectively, of which $2.2 million and
$200,000 related to research and development performed under the Development
Agreement, which was converted to the Support Agreement in July 1996.
Additionally, the Company recognized $1.3 million in connection with the Support
Agreement and a $200,000 fee in connection with the Almirall Agreement in 1997.
Research and development expenses increased 83% from $3.6 million in 1996
to $6.6 million in 1997. This increase was due primarily to increased activity
and costs associated with the pharmaceutical and clinical development of
Valstar(TM), including manufacturing, validation and preparation for filing the
NDA in the United States and a similar application in Europe.
General and administrative expenses increased from $523,000 in 1996 to
$682,000 in 1997, primarily due to increased business development activities.
Other income (expense) increased from $111,000 in 1996 to $139,000 in 1997
due to higher cash and cash equivalent balances resulting from the conversion of
the Development Agreement to the Support Agreement.
Net loss increased from $1.9 million in 1996 to $5.5 million in 1997 due to
the increase in research and development spending and due to the discontinuation
of development revenue following the conversion of the Development Agreement to
the Support Agreement in July 1996.
LIQUIDITY AND CAPITAL RESOURCES
From inception through June 30, 1998, the Company has not generated
positive cash from operations and, accordingly, has financed its operations
primarily with the net proceeds received from private placements of Preferred
Stock, and research, development and licensing agreements. Such proceeds have
totaled approximately $30.6 million, and are comprised of the following: equity
investments of approximately $18.7 million; revenue from research arrangements
with Schering AG, Germany of approximately $3.7 million; and payments received
under licensing and development agreements of approximately $8.2 million
(approximately $8.0 million pursuant to the Medeva Agreement and $200,000 from
Almirall).
28
31
Net cash used in operating activities was $2.5 million, $3.9 million and
$9.3 million in 1996, 1997 and 1998, respectively.
Cash and cash equivalents at June 30, 1998, totaled $2.9 million, compared
with $795,000 as of June 30, 1997, primarily as the result of funds received
pursuant to the Medeva Agreement, and from an equity investment by Nycomed in
Anthra, net of cash used in operations.
The Company anticipates that annual expenditures for clinical trials,
product development, preclinical studies, and general and administrative expense
will increase significantly in future years. In anticipation of the possible FDA
approval for marketing of Valstar(TM), the Company expects to begin preparing
for the commercialization of the Company's first product during 1999 and to
accelerate such preparation in 2000, adding substantial additional expense.
However, there can be no assurance that the Company will be able to successfully
complete the clinical development of Valstar(TM) for bladder cancer or any other
indication, that the FDA will grant approval within the time frame expected, if
at all, that the other developments or expansions in the Company's programs of
research, development and commercialization will not require additional funding
or encounter delays, or that, in light of these or other circumstances, the
Company will be able to achieve its planned levels of revenue, expense and cash
flow.
In July 1997, the Company executed a sublease for approximately 5,560
square feet located in the Carnegie Center in Princeton, New Jersey. The monthly
rent is $9,359, and the lease expires on November 30, 1999. The Company also
leases approximately 1,635 square feet of office space at The Malt House,
Princes Risborough, England for its Anthra UK offices. The quarterly rent is
L5,535 ($9,299 using a conversion factor of 1.68 dollars for 1 British pound),
and the lease expires in December 2000.
The Company expects to finance its continued growth and development
principally through this Offering and arrangements with strategic partners. The
Company believes the net proceeds from this Offering, together with current cash
and cash equivalent balances, the interest on combined cash balances, and
contingent funding (including royalties) from its Collaborative Partners, will
provide the Company with sufficient working capital to sustain operations
through approximately 1999, although there can be no assurance that the Company
will not require additional funding prior to that time. The Company anticipates
that if there are delays in its current programs, if its current programs of
research and development yield expansion opportunities, or if there are changes
in competitive and technological advances, the regulatory approval process or
other factors, the Company would seek additional financing, whether through
public or private equity or debt financings, corporate alliances, or
combinations thereof. In addition, the Company may require additional financing
in connection with its potential future product acquisition activities.
There can be no assurance that additional equity or debt capital will, if
needed, be available on terms acceptable to the Company, if at all. Any
additional equity financing could be dilutive to stockholders. Debt financing,
if available, may include restrictive covenants. If additional funds should be
needed but are not available, the Company may be required to curtail its
operations significantly or to obtain funds by entering into collaborative
arrangements or other arrangements on unfavorable terms. The failure by the
Company to raise capital on acceptable terms if and when needed would have a
material adverse effect on the Company's business, financial condition and
results of operations.
The Company anticipates that the annual expenditures for research support
for Bonefos(R) to increase significantly during 1999, and to continue until at
least 2002. In addition, the Bonefos Option Agreement contemplates future
payments from the Company of $800,000 upon the execution of the Bonefos
Agreements, and $2.5 million upon the earlier of completion of a satisfactory
pre-NDA meeting with the FDA with respect to Bonefos(R) or December 31, 1998.
There can be no assurance that the Company will be able to successfully complete
the clinical development of Bonefos(R) for the treatment of hypercalcemia and
lytic bone disease, or that the FDA will grant the required approvals within the
time frame anticipated by the Company, if at all.
INFLATION
The Company does not believe that inflation has had any significant impact
on the Company's business to date.
29
32
YEAR 2000 COMPLIANCE
The Year 2000 issue is the result of computer programs being written using
two digits rather than four to define the applicable year. Any programs that
have time-sensitive software may recognize a date using "00" as the year 1900
rather than the year 2000. This could result in a major system failure or
miscalculations. The Company is currently engaged in a two-phase process to
evaluate its readiness with respect to the Year 2000 issue.
In the first phase, which the Company completed in the fourth quarter of
1998, the Company conducted an evaluation of its internal systems, including
both information technology ("IT") systems and non-IT systems such as hardware
containing embedded technology, for Year 2000 compliance. Based on this
evaluation, the Company does not believe that the impact of the Year 2000 issue
will be material on its internal systems.
In the second phase, the Company is taking steps to ensure that third
parties with which the Company has material relationships are Year 2000
compliant. To date, a confirmation has been received from the Company's primary
marketing partner that it is Year 2000 compliant. The Company also plans to
communicate with other third parties that it does business with to coordinate
Year 2000 readiness, which process is expected to be completed by the second
quarter of 1999.
Based upon the steps being taken to address this issue and the progress to
date, the Company believes that the Company's internal systems are Year 2000
compliant. In addition, the costs incurred and expected to be incurred by the
Company with respect to this process are not expected to be material. As a
contingency plan, the Company intends to mitigate the impact of noncompliance of
third parties with which the Company does business, by establishing contractual
relationship with alternative suppliers. The failure of third parties with which
the Company does business to remediate Year 2000 problems in their IT and non-IT
systems could have a material adverse impact on the operations of the Company.
THE ESTIMATES AND CONCLUSIONS HEREIN CONTAIN FORWARD-LOOKING STATEMENTS AND
ARE BASED ON MANAGEMENT'S BEST ESTIMATES OF FUTURE EVENTS. RISKS TO COMPLETING
THE TWO-PHASE PROCESS INCLUDE THE AVAILABILITY OF RESOURCES AND THE ABILITY OF
THE COMPANY'S THIRD-PARTY VENDORS TO BRING THEIR SYSTEMS INTO YEAR 2000
COMPLIANCE.
IMPACT OF RECENTLY ISSUED ACCOUNTING STANDARDS
Statement of Financial Accounting Standards No. 130, "Comprehensive Income"
(SFAS 130), was issued in June 1997. SFAS 130 becomes effective for the
Company's fiscal year 1999 and requires reclassification of earlier financial
statements for comparative purposes. SFAS 130 requires that all items defined as
comprehensive income, including changes in the amounts of certain items, foreign
currency translation adjustments and gains and losses on certain securities, be
shown in a financial statement. SFAS 130 does not require a specific format for
the financial statement in which comprehensive income is reported, but does
require that an amount representing total comprehensive income be reported in
that statement. The Company believes that the adoption of SFAS 130 will not have
a material effect on the consolidated financial statements.
Statement of Financial Accounting Standards No. 131, "Disclosures about
Segments of an Enterprise and Related Information" ("SFAS 131"), was issued in
June 1997. SFAS 131 becomes effective for the Company's fiscal year 1999 and
requires restatement of disclosures for earlier periods presented for
comparative purposes. This new standard requires companies to disclose segment
data based on how management makes decisions about allocating resources to
segments and how it measures segment performance. SFAS 131 requires companies to
disclose a measure of segment profit or loss, segment assets, and
reconciliations to consolidated totals. It also requires entity-wide disclosures
about a company's products and services, its major customers and the material
countries in which it holds assets and reports revenues. The Company believes
that the adoption of SFAS 131 will not have a material effect on the
consolidated financial statements.
30
33
Statement of Financial Accounting Standards No. 132, "Employers'
Disclosures about Pensions and Other Postretirement Benefits" ("SFAS 132"), was
issued in February 1998. SFAS 132 becomes effective for 1999 and requires
restatement of disclosures for earlier periods presented for comparative
purposes. SFAS 132 revises employers' disclosure about pension and other
postretirement benefit plans. It does not change the measurement or recognition
of those plans but rather standardizes the disclosure requirements for pensions
and other postretirement benefits to the extent practicable, requires additional
information on changes in the benefit obligations and fair values of plan assets
that will facilitate analysis, and eliminates certain disclosures that are no
longer useful. The Company believes that the adoption of SFAS 132 will not have
a material effect on the consolidated financial statements.
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34
BUSINESS
GENERAL
Anthra is a specialized pharmaceutical company engaged in managing clinical
development and obtaining regulatory approval of NDAs and sNDAs for a portfolio
of its proprietary cancer drugs. The Company's current drug candidates are for
the treatment of patients with superficial cancer of the bladder, ovarian and
prostatic cancer, and complications from metastatic cancer (hypercalcemia and
lytic bone disease). The Company's strategy is to develop only late stage drug
candidates, thereby improving the likelihood of successfully obtaining NDA/sNDA
and equivalent foreign approvals. The Company directs its search for oncology
drug candidates toward selected large pharmaceutical companies, because of the
difficulty many of these companies have experienced in managing oncology
projects, and at biotechnology and early stage discovery companies that lack
clinical and regulatory proficiency. To maximize the return on its investment in
each drug, Anthra seeks approvals for multiple disease indications for each
product and directly manages both its United States and foreign clinical
programs and regulatory submissions. At the present time, Anthra has entered
into four marketing agreements with major multinational drug companies for which
it has received certain initial payments and expects significant additional
payments in the form of milestone fees and royalty and supply payments.
In December 1997, Anthra filed an NDA for its first product, Valstar(TM),
for treatment of patients with superficial bladder cancer whose principal
current alternative is the surgical removal of their urinary bladder. In January
1998, Anthra received priority designation from the FDA for the review of this
NDA. On June 1, 1998, ODAC reviewed Valstar(TM) and declined to recommend
approval to the FDA of Valstar(TM) without additional analyses. On September 1,
1998, ODAC re-evaluated Valstar(TM) and voted to recommend to the FDA approval
of Valstar(TM) for treatment of patients with the ODAC Recommended Indication.
The Company anticipates that the NDA for Valstar(TM) for this indication will be
approved by the FDA in 1998. See "-- Government Regulation."
Valstar(TM) is an anthracycline with multiple cytotoxic mechanisms that was
discovered at Dana-Farber. Valstar(TM) has been shown to have significant
activity against a variety of tumor cell lines and is not associated with
significant contact toxicity, thereby making it an ideal choice for regional
chemotherapy. The Company's pivotal clinical studies, have demonstrated a
complete response rate of 18% (which rate was supported by the FDA) in a group
of 90 patients with bladder cancer who had not responded satisfactorily to
extensive pre-treatment with BCG, the accepted first line treatment for
superficial bladder cancer. There are currently no drugs approved in the United
States or Europe for second-line treatment of bladder cancer following BCG
therapy. For these patients, surgical removal of the bladder is the only
approved definitive form of therapy. Importantly, 35% of the patients in the
Company's pivotal clinical studies retained their bladder up to 48 months
following study entry. Anthra, consistent with its multiple disease indication
strategy, is developing Valstar(TM) for three additional indications. One Phase
III program is directed at patients with papillary superficial bladder cancer,
for whom approximately 180,000 transurethral resection procedures are being
performed annually in the United States. In another Phase III program involving
patients with ovarian cancer, Valstar(TM) is being administered directly into
the peritoneal cavity, where the cancer is confined. In addition, Anthra plans
to commence a Phase I program to obtain approval for use of Valstar(TM) in
treating prostate cancer. The Company has researched the historical incidence of
each of these diseases based on publicly available information and reports
prepared for the Company by MedProbe, including a report summarizing the results
of a survey of 1.5% (124) of office and hospital based urologists reported to be
members of the AMA. Although precise patient data is not published and can vary
significantly from year to year, based on the foregoing research and certain
assumptions made by the Company, including the estimated cost of treating each
of the estimated number of patients with Valstar(TM), the Company estimates that
the potential market for Valstar(TM) in the United States could approximate
nearly $600 million per annum, and that foreign markets will provide a
significant additional opportunity for sales of Valstar(TM). See "-- Products
and Markets." No assurance can be given by the Company that this estimated
market for Valstar(TM) will be achieved.
Medeva has committed up to $26.2 million (of which $10.1 million has been
paid to date) and the payment of future royalties for the right to market and
sell Valstar(TM) in the United States. Anthra currently
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has similar arrangements for Valstar(TM) with Nycomed, and Almirall, with
respect to marketing and sales rights in Europe. In total, Anthra has entered
into agreements for Valstar(TM) providing potential equity investment, licensing
and development fees and milestone payments of up to $42.9 million (of which
$24.4 million has been paid to date), plus additional royalty and supply
payments. See "-- Products and Markets."
In accordance with the Company's corporate development strategy, Anthra
identified Bonefos(R), a product for the treatment of hypercalcemia and lytic
bone disease associated with breast and lung cancer and owned by Schering AG,
Germany, the Company's largest pharmaceutical shareholder. Bonefos(R) has been
on the market in Europe and the rest of the world since 1985, with worldwide
sales of approximately $150 million in 1997. In July 1998, Anthra entered into
the Bonefos Option Agreement to acquire the exclusive United States development
and marketing rights to Bonefos(R) for the hypercalcemia and lytic bone disease
indications, for payments aggregating $3.75 million, including a nonrefundable
$250,000 payment under a prior term sheet. In consideration of the Company's
nonrefundable payment of $200,000 (also included in the $3.75 million), the
Bonefos Option Agreement grants the Company the option to enter into the Bonefos
Agreements, both of which have been fully negotiated. See "-- Products and
Markets -- Bonefos(R): Bonefos Option Agreement." The Company intends to
exercise this option prior to the expiration of the option on September 30,
1998, by making an additional nonrefundable $800,000 payment to Leiras Oy.
Following the execution of the Bonefos Agreements in conjunction with the
Company's exercise of its option under the Bonefos Option Agreement, the Company
plans to conduct Phase III trials in the United States for Bonefos(R) for the
hypercalcemia and lytic bone disease indications. The Bonefos Agreements provide
that, upon FDA approval of an NDA for Bonefos(R), Berlex will have the option to
acquire from the Company the exclusive right to market Bonefos(R) in the United
States for the hypercalcemia and lytic bone disease indications for payments of
up to $21 million, plus future royalties. The Company has researched the
historical incidence of hypercalcemia and the types of lytic bone disease that
Bonefos(R) treats based on publicly available information. Although precise
patient data is not published and can vary significantly from year to year,
based on the foregoing research and certain assumptions made by the Company,
including the estimated costs of utilizing Bonefos(R) for the treatment of these
maladies using each of the estimated number of patients, the Company estimates
that the potential market for Bonefos(R) in the United States could approximate
nearly $900 million per annum. See "-- Products and Markets." No assurance can
be given by the Company that this estimated market for Bonefos(R) will be
achieved.
Anthra believes that its strategy and accomplishments have positioned it to
become a recognized platform for the clinical substantiation and regulatory
approval of cancer drugs capable of treating multiple disease indications. The
Company is currently assessing and evaluating additional cancer-related late
stage candidates for acquisition, although no definitive agreements have been
executed. Management believes that focused, cost effective development increases
the likelihood of successful clinical development and regulatory approval.
Indicative of this strategy has been the Company's success in filing an NDA for
Valstar(TM) at a total research and development cost of less than $20 million.
According to PPSS, in the United States, the cost of developing an approved new
drug has been estimated to be between $304 million and $608 million.
The Company currently has one wholly-owned subsidiary, Anthra UK, through
which it manages its program for Europe. In addition, in order to centralize the
testing, manufacturing and storage of Valstar(TM) and Bonefos(R) in close
proximity to the intended suppliers of starting materials, manufacturers and
warehousers of Valstar(TM) and Bonefos(R), which are located either in
Switzerland or elsewhere in Europe, the Company may form one or more wholly
owned Swiss subsidiaries, which would hold substantially all the Company's
rights to Valstar(TM) and Bonefos(R). In this manner, the Company believes it
would be better able to control and oversee the manufacturing supply,
development and distribution of Valstar(TM) and Bonefos(R) in the amounts
required.
INDUSTRY OVERVIEW
As pharmaceutical product development has become progressively more costly
and complex, maintaining the pace of innovation in the pharmaceutical industry
has been difficult. According to PPSS, in the United States, the cost of
developing a new drug has been estimated to be between $304 million and $608
million. According to the Tufts Center for the Study of Drug Development, it
takes 15 years, on average, for an experimental drug to travel from the clinical
laboratory to use in treatment of United States patients. The
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average clinical development time for drugs approved in 1994 and 1995 by the FDA
was seven years, compared to six years for drugs approved from 1990 to 1993.
Only five in 5,000 compounds that enter pre-clinical testing make it to human
trials; and only one of those five is approved by the FDA. According to the
Pharmaceutical Research and Manufacturers Association, investment in research
and development by research-based pharmaceutical companies has increased
dramatically since 1980. In fact, over the past ten years, research and
development investment has more than tripled from $6.5 billion in 1988 to a
projected $20.6 billion in 1998. Over the next decade, most large and
medium-sized pharmaceutical companies will grapple with the fact that many of
their most profitable products are nearing the end of patent protection and
their research and development efforts are not producing replacements to
continue to justify the significant investments which such companies have made
in their sales and marketing infrastructure. Thus, there is significant and
growing demand for drugs that have a high probability of reaching the market in
the near term.
The shortage of effective drugs is particularly acute in the oncology
market. Cancer already is responsible for nearly 25% of the deaths in the United
States and, if mortality rates for other leading causes of death, such as heart
disease and stroke, continue their declining trends, cancer will become the
leading cause of death among Americans in the early 21()st century. According to
Healthcare Forecasting Incorporated Reports, the oncology drug market in 1996
was estimated to be $3.1 billion. Oncology is currently one of the five largest
therapeutic markets in the United States and Europe, but few major
pharmaceutical companies participate in this market on a worldwide level.
Moreover, most of the most active and widely used chemotherapeutic drugs have
been on the market for a decade or more, and are thus at or nearing the end of
their patent protection period.
Due to this shortage of new drugs entering the market, as a direct result
of the Prescription Drug User Fee Act of 1992, as amended, the FDA has devoted
more resources to the review of NDAs, including NDAs for new molecular entities
("NMEs"), and to the review of supplemental applications for expanded claims.
The process has taken less time than it did previously, and an increased number
of products are receiving approval. In 1996, 53 NME's (up from 26 in 1995) and
nine biological products (up from two in 1995) were approved. Of those approved
in 1996, five were oncology drugs: docetaxol, gemcitabine, irinotecan,
nilutamide, and topotecan. The 17 drugs designated for "priority review" in 1996
were approved in an average time of 13.7 months. In 1997, 39 NMEs and 10
biological products were approved. A significant trend towards shorter approval
times has been observed for NMEs (9% decrease to 16.2 months from the previous
year). In 1997, nine NMEs and three biological products received priority
review -- four of the nine priority NMEs and all of the priority biological
products were approved within six months of filing acceptance. Of the 1997
approvals, six were oncology products: intrapleural talc, samarium sm 153 EDTMP,
letrozole, toremifene, oprelvekin and rituximab. Interferon alfa-2b, previously
approved for use in hairy cell leukemia and hepatitis, received approval of a
supplemental application for an additional oncology claim. The mean approval
time of the last six priority oncology drug products (NMEs) granted priority
review was 12 months. With the Food and Drug Administration Modernization Act of
1997, as amended (the "FDAMA"), user fees have been extended for five years and
a variety of measures designed to expedite review of drugs and biological
products have been enacted. Whether they will have any effect in general or with
respect to any drugs that the Company is or will be developing, and the
magnitude of any such effect, cannot be known.
The foregoing trends have created an opportunity that is being exploited by
the numerous smaller specialized pharmaceutical companies that have emerged over
the past decade. For example, hundreds of drug discovery and research based
companies have been formed around scientific advances in the understanding of
cancer. Despite the promise of these advances, however, few products have
emerged, in part because these companies lack the expertise in clinical
development needed to ensure the development and commercialization process is
completed in a timely and cost effective manner. Many larger companies also lack
experience in clinical development of oncology products because they focus on
large single disease markets, whereas cancer is a heterogeneous set of diseases.
Anthra had positioned itself as a specialized pharmaceutical company, dedicated
to the clinical and commercial development of cancer drugs. Anthra's record of
performance with the development of and filing of an NDA for Valstar(TM)
supports this positioning in that the clinical development time for such NDA was
5.5 years and the total cost to file the NDA was under $20 million.
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BUSINESS STRATEGY
The availability of a large number of novel compounds with therapeutic
potential, combined with the pressing demand by major pharmaceutical companies
for approved products, has created a significant opportunity for organizations
with expertise in the transformation of promising lead compounds into safe and
effective drugs. Furthermore, Anthra believes that the clinical development of
cancer drugs can be less costly and presents a lower risk than drug development
for other major diseases because of the FDA's policy with respect to drugs for
life-threatening diseases, such as cancer. Anthra intends to exploit these
opportunities by implementing a strategy based on the following key elements:
- CONCENTRATE ON THE CLINICAL AND COMMERCIAL DEVELOPMENT OF DRUGS WITH
DEMONSTRATED ACTIVITY IN THE TREATMENT OF SPECIFIC TYPES OF CANCER. The
Company draws upon the expertise of its management team and its Scientific
Advisory Board, as well as established relationships with pharmaceutical
companies and research organizations, to identify and procure rights to
oncology compounds which have exhibited a potential for late-stage
development. The Company believes that this focus will enable it to build
a strong product portfolio without extensive investment in the
infrastructure required to support drug discovery efforts and pre-clinical
research.
- MINIMIZE THE TIME AND COST OF DRUG DEVELOPMENT BY THE PRUDENT SELECTION
OF PRODUCT CANDIDATES AND DISEASE INDICATIONS AND THROUGH THE RIGOROUS
DESIGN AND IMPLEMENTATION OF CLINICAL TESTING PROGRAMS. The Company has a
detailed checklist of requirements that any potential drug candidate must
satisfy. The drug candidate must be a novel, proprietary compound for use
in treatment and/or management of cancer or complications from cancer. The
drug candidate must have a pre-clinical and manufacturing dossier that
will support an investigational new drug application (an "IND") with the
FDA. Except in exceptional circumstances, the drug candidate should have
undergone early clinical testing that demonstrated safety and activity in
humans. The drug candidate should have broad enough activity to support
claims for multiple disease indications. Recognizing that the scrupulous
direction and management of the clinical trials process is absolutely
crucial to rapid and cost effective drug development, Anthra fully
supports the studies it sponsors, maintaining direct contact with all
participating clinical investigators and sites. For its Valstar(TM)
program, for example, clinical studies were conducted at more than 100
sites in the United States and Europe.
- STAGE DEVELOPMENT OF DRUG CANDIDATES TO REDUCE RISKS INHERENT IN CLINICAL
STUDIES. Anthra's initial stage of clinical development focuses on a
specific disease indication where safety and efficacy can be easily and
reliably demonstrated to support filing for regulatory approval and rapid
market penetration. Because regulatory authorities recognize the need for
new drugs to treat the many cancer indications for which there are neither
definitive treatments nor approved products, the clinical trials and
regulatory approvals process is more expeditious than for other disease
states. The later phases of clinical development target broader
indications and support supplemental regulatory filings that lead to
expanded markets for the product.
- ADDRESS THE SIGNIFICANT AND GROWING DEMAND OF LARGE AND MEDIUM-SIZED
PHARMACEUTICAL COMPANIES FOR NEW ONCOLOGIC PRODUCTS. A recent Arthur
Andersen LLP survey reported that the development pipelines of large drug
companies are producing only 10% of the new products needed to sustain
their current economic returns. With many of their profitable drugs slated
to lose patent protection over the next five to seven years, these
companies are actively seeking marketing and development rights for new
products at or near the stage of filing for regulatory approvals.
- FORM STRATEGIC COLLABORATIONS WITH SELECTED CORPORATE PARTNERS. Anthra
has established and will continue to pursue arrangements with
pharmaceutical companies to provide the Company with access to promising
compounds, and marketing and distribution capability for approved
products. These arrangements should allow Anthra to concentrate on its
strength in clinical development, while providing Anthra with financing
for growth and the acquisition of additional compounds.
- CAPITALIZE ON THE SIGNIFICANT INVESTMENT IN CANCER DRUG DISCOVERY AT
ACADEMIC INSTITUTIONS AND SPECIALIST R&D COMPANIES. Because many of these
institutions and companies lack the experience
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and resources to transform promising new compounds into marketable
products, Anthra is advantageously positioned to negotiate licensing
agreements for clinical and commercial development of these drugs.
Anthra has demonstrated with Valstar(TM) that it can implement the
foregoing strategy successfully. Anthra has completed the initial phase of its
Valstar(TM) program and filed an NDA in December 1997 based on clinical trials
of Valstar(TM) for treatment of refractory bladder cancer, less than five years
after the Company established the drug's activity and launched pivotal clinical
studies for this indication. With the arrangements it has established, including
those with Medeva, Nycomed and Almirall, the Company may receive up to a total
of $42.9 million (of which $24.4 million has been paid to date) in licensing and
development fees, milestone payments and equity investments, plus additional
royalty and supply payments.
PRODUCTS AND MARKETS
Many specialized pharmaceutical companies are built on a technology
platform that generates many lead compounds, only a small fraction of which can
be developed into products. In contrast, Anthra specializes in developing late
stage drug candidates into marketable products. Anthra has invested and intends
to continue to invest its resources only in drug candidates that have both
evidence of safety and activity in humans, and the potential to treat both
narrow and broad disease indications.
VALSTAR(TM): A NOVEL ANTHRACYCLINE FOR REGIONAL CHEMOTHERAPY
Valstar(TM) is an anthracycline with multiple cytotoxic mechanisms that was
discovered at Dana-Farber. Anthracyclines such as doxorubicin and daunorubicin
are among the most active and widely used anti-tumor agents in the current
pharmacopoeia. Pre-clinical studies and early institutional clinical trials at
Dana-Farber indicated that the pharmacologic profile of Valstar(TM) makes it
particularly attractive as an agent for regional chemotherapy, i.e., the direct
administration of a concentrated drug solution to a body cavity or organ.
Regional chemotherapy is designed to maximize treatment of locally confined
tumors by delivering very high doses of the therapeutic agent to the afflicted
organ or region while reducing systemic exposure to such agent and the
consequent side effects. As a lipophilic molecule, Valstar(TM) penetrates cell
membranes rapidly. Valstar(TM) has been shown to have significant activity
against a variety of tumor cell lines and is not associated with significant
contact toxicity, thereby making it an ideal choice for regional chemotherapy.
Finally, no cumulative cardiotoxicity has been observed with Valstar(TM) as
opposed to other anthracyclines.
Anthra's clinical development program for Valstar(TM) has focused on two
primary routes of administration: intravesical ("IVe") (instillation of the drug
solution in the bladder) and intraperitoneal ("IP") (introduction of the drug
solution into the peritoneal cavity). The Company is sponsoring clinical studies
of Valstar(TM) to support applications to market the drug in these and other
regions. In addition, Anthra has sponsored pre-clinical studies to test the
feasibility of administering Valstar(TM) directly into the prostate gland via
direct injection. Table I is an overview of Anthra's Valstar(TM) clinical
development program. There can be no assurance, however, that Anthra will
receive approval to market Valstar(TM) for the claims listed in Table I. See
"Risk Factors -- Uncertainties Related to Clinical Trials; Uncertainty of
Government Regulatory Requirements; Lengthy Approval Process."
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TABLE I. SUMMARY OF VALSTAR CLINICAL DEVELOPMENT PROGRAM
INDICATION/
TREATMENT TYPE RATIONALE STATUS OF DEVELOPMENT
- ------------------------------ ------------------------------ ------------------------------
Refractory Superficial Bladder - No agents approved for - United States NDA filed;
Cancer/Intravesical (IVe) refractory indication Orphan Drug designation
- High dose intensity; - ODAC recommended the ODAC
prevent/delay cystectomy Recommended Indication
- European EMEA application
filed
- ----------------------------------------------------------------------------------------------
Papillary Bladder Cancer/ - No agents approved for claim - United States Phase III
IVe Immediately Following in United States study ongoing
TURB - High dose intensity; - European Phase III study to
prevent/delay disease be launched in fiscal year
recurrence and/or 1999
progression
- Low incremental cost to
healthcare system
- ----------------------------------------------------------------------------------------------
Advanced Refractory Ovarian - IP administration of - United States and Canada
Cancer/Intraperitoneal (IP) cytotoxic agents has been Phase III study ongoing
shown to be of clinical - European Phase III protocol
value compared to proposed
intravenous administration
- No agents approved for IP
administration
- High dose intensity;
maximize pharmacologic
advantage of IP therapy
- ----------------------------------------------------------------------------------------------
Locally Confined Prostate - No effective chemotherapy - United States Phase I
Cancer/Intraprostatic (local or systemic) protocol accepted by FDA;
Injection - Excellent pre-clinical activation planned for
safety profile fiscal year 1999
- Regional treatment to
prevent/delay prostatectomy
- ----------------------------------------------------------------------------------------------
BLADDER CANCER -- OVERVIEW AND MANAGEMENT
In the United States, bladder cancer affects 54,000 new patients annually
and there are over 500,000 patients living in the United States who have been
diagnosed with the disease. It is approximately three to four times more common
in men than women and the disease most frequently occurs in the sixth and
seventh decades of life. Figure 1 depicts the management of patients with
bladder cancer. The two principal forms of the disease are invasive (occurring
in approximately 10% to 15% of patients) and superficial (occurring in the
remainder). The majority of patients diagnosed with bladder cancer have
superficial transitional cell carcinoma. Patients diagnosed with invasive
disease typically undergo surgical removal of the bladder (cystectomy) and often
require systemic chemotherapy, while patients with superficial disease are
managed much more conservatively.
There are two principal types of superficial bladder cancer: carcinoma
in-situ and papillary tumors. Most commonly, papillary tumors are characterized
as having a low to intermediate potential for invasion and are managed by
transurethral resection of the bladder ("TURB") and surveillance cystoscopy with
repeat TURB upon documented recurrence. However, some patients are considered to
have aggressive disease with a high risk of developing invasion, thereby
requiring IVe (in the bladder) administration of BCG therapy. Patients with
carcinoma in-situ are considered to be at high risk of developing invasive
disease and require IVe administration of BCG therapy.
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FIGURE 1. BLADDER CANCER MANAGEMENT
[BLADDER CANCER MANAGEMENT CHART]
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VALSTAR(TM) IN PATIENTS WITH BCG-REFRACTORY SUPERFICIAL BLADDER CANCER
Prior to the introduction of BCG, patients with carcinoma in-situ and high
risk papillary tumors underwent cystectomy due to the aggressive nature of the
disease. With BCG, the need to use cystectomy in patients with superficial
bladder cancer has been markedly reduced. Complete response rates with BCG
treatment are in the 70% range. When patients are shown to have had an
inadequate response to BCG, that is, are not rendered disease-free or recur
following recommended BCG treatment regimens, they are considered refractory,
and surgical removal of the bladder is the principal treatment. Due to the
significant alteration in life style, near term and long-term complications, and
compromise of quality of life, patients and physicians desire greatly to salvage
bladders. However, there are currently no drugs approved in the United States or
Europe for second-line treatment of bladder cancer following BCG therapy.
Anthra has targeted the first use of Valstar(TM) for patients with
refractory superficial bladder cancer. In 1993, the Company began pivotal
clinical studies after discussing the requirements for approval of Valstar(TM)
for this claim with the FDA. Anthra applied for and received Orphan Drug
designation for Valstar(TM), which would confer seven years of market
exclusivity upon NDA approval, for the treatment of patients with this
condition. Accrual and follow-up in the pivotal studies for the NDA for this
claim concluded in April 1997 and such NDA was submitted to the FDA in December
1997. The studies included 90 patients with BCG-refractory disease; 58% of whom
received at least three prior courses of IVe therapy. Life table analyses
revealed that the probability of obtaining a complete response (no evidence of
disease documented by cystoscopic inspection with biopsy and cytology) to
Valstar(TM) treatment was 18%, which conclusion was supported by the FDA.
Importantly, 35% of the patients (based on Kaplan Meier life-table estimates
with up to 48 months follow up) enrolled in the studies did not undergo
cystectomy. Thus, Valstar(TM) provided many patients with the opportunity for
meaningful bladder salvage.
The FDA has begun its evaluation of the aforementioned NDA and gave the
application "priority review" status. Such status is no assurance that the NDA
will be approved or that, if approved, the approval will be granted within any
particular period of time. In the course of reviewing NDAs, the FDA often finds
it necessary to call upon the knowledge of experts in clinical research and the
treatment of patients. The FDA has instituted an advisory committee system to
assist in the establishment of guidelines with respect to the clinical
development of new drugs for a variety of diseases and to help the FDA in the
evaluation of specific NDAs. On June 1, 1998, ODAC reviewed Valstar(TM) and
declined to recommend that the FDA approve Valstar(TM) without additional
analyses. On September 1, 1998, ODAC re-evaluated Valstar(TM) and voted to
recommend to the FDA approval of Valstar(TM) for treatment of patients with the
ODAC Recommended Indication. However, such recommendation is not binding on the
FDA. While the Company anticipates that the NDA for Valstar(TM) for the ODAC
Recommended Indication will be approved by the FDA in 1998, there can be no
assurance that the FDA will follow ODAC's recommendation. If this NDA is
approved, Valstar(TM) will be marketed for IVe administration to the
approximately 6,000 urologists in the United States by Medeva. See
"-- Valstar(TM) -- Licensing Agreements." The Company has also agreed to provide
Valstar(TM) to the Eastern Cooperative Oncology Group ("ECOG") for a study that
the Company commenced in July 1998 involving patients with all forms of
superficial bladder cancer who have proven refractory to BCG treatment.
In May 1998 the Company filed with the European Agency for the Evaluation
of Medicinal Products ("EMEA") an application for approval of a similar claim in
Europe based upon the results of a pivotal study that it performed at five study
centers in three European countries and the results of the pivotal studies
conducted in the United States. The European study evaluated Valstar(TM) in the
treatment of 45 patients with high risk superficial bladder cancer who were
refractory to multiple TURB procedures and IVe courses of treatment with BCG and
mitomycin. Complete responses confirmed by cystoscopic evaluation with biopsy
and cytology were documented in approximately 50% of patients with residual
papillary tumors at the time of treatment with Valstar(TM). No drugs are
approved in Europe for the treatment of patients with refractory high-risk
superficial bladder cancer. The EMEA has accepted Valstar(TM) for the
centralized review procedure. Drugs accepted for review under the centralized
procedure are given ten year marketing exclusivity from the date of approval in
all European Union ("EU") countries. The Company plans to seek approval for
Valstar(TM) in other European countries, as well. If approved, Nycomed and
Almirall will market Valstar(TM) to urologists throughout Europe.
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VALSTAR(TM) IN PATIENTS WITH LOW TO INTERMEDIATE RISK PAPILLARY SUPERFICIAL
BLADDER CANCER
Papillary tumors are the most common form of superficial bladder cancer and
patients with a low to intermediate risk of developing invasive disease far out
number those with aggressive forms of the disease. The principal form of
treatment of patients with papillary tumors is TURB. Patients with papillary
tumors typically have recurrence necessitating repeat TURB procedures.
Recurrence rates depend upon the number, stage and grade of the tumors. Most of
the 180,000 TURBs performed annually in the United States are undertaken
involving patients with recurrent superficial bladder cancer. As illustrated in
Figure 2, during the TURB procedure, a rigid cystoscope is inserted into the
bladder via the urethra and overt tumors are resected and biopsies are taken
from areas suspicious for tumor involvement. Normal appearing areas of the
bladder mucosa are frequently sampled in an effort to diagnose carcinoma
in-situ, which is not often visible. There are several theories regarding the
biology of recurrence, including regrowth of excised tumors, development of new
tumors due to genetic and environmental factors, and implantation of tumor cells
at the time of TURBs in areas denuded during the procedures. Implantation of
stray "floating" tumor cells in areas in which the urothelium has been disrupted
may be followed by the growth of the implanted cells to form a new tumor. This
is especially so after the affected area has healed (re-epithelialization). The
best opportunity to interfere with the pathophysiology of implantation-mediated
recurrence is prior to the re-epithelialization of the sites denuded during the
TURB, that is, as soon as possible following the procedure. The administration
of an IVe agent shortly after the TURB has been shown to reduce recurrence
rates, presumably by destroying residual floating tumor cells before they can
implant or prior to re-epithelialization of areas in which tumor cells have
landed.
FIGURE 2. ADJUNCTIVE TREATMENT WITH VALSTAR(TM)
[TURB PROCEDURES GRAPHIC]
There are no drugs in the United States approved for IVe administration
shortly after TURB. In fact, BCG, the most widely used IVe agent, is
contraindicated for patients with any signs of compromised bladder integrity
because sytemetization of the tubercle bacillus has led to severe adverse
reactions. Anthra has conducted a Phase I/II study of Valstar(TM) administered
immediately following TURB in 22 patients. This study documented the safety of
adjunctive administration of Valstar(TM) and served as the basis for discussions
with the FDA regarding the development of Valstar(TM) for approval in this
setting. Anthra has commenced a Phase III randomized pivotal study of adjunctive
Valstar(TM). The results of this study, if positive, will serve as the basis for
FDA approval of Valstar(TM) for single-dose adjunctive therapy in conjunction
with TURB procedures. If approved, Valstar(TM) will be marketed for IVe
administration to the 6,000 urologists in the United States by Medeva. See
"-- Valstar(TM) -- Licensing Agreements." The Company will also seek European
approval of adjunctive therapy for low to intermediate risk papillary tumors. If
approved, Nycomed and Almirall will market Valstar(TM) to urologists throughout
Europe.
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VALSTAR(TM) IN PATIENTS WITH OVARIAN CANCER
Ovarian cancer affects 25,400 new patients annually in the United States,
and there are approximately 60,000 patients in the United States that have been
diagnosed with the disease. With an estimated 14,500 deaths in 1996, ovarian
cancer caused more deaths in the United States than any other cancer of the
female reproductive system. Ovarian cancer is often "silent", showing no signs
or symptoms until late in its development, and only 23% of all cases are
detected at a localized stage. Figure 3 illustrates the management of ovarian
cancer. Aggressive surgery, that is, removal of all sites of tumor involvement
as well as the ovaries, fallopian tubes, and uterus, is typically performed.
Front-line systemic chemotherapy is then typically administered. Although the
regimens employed in up-front treatment continue to be optimized, in the United
States the use of intravenously administered platinum and paclitaxel is the
standard. In a large study performed by the Southwest Oncology Group ("SWOG"),
the Gynecologic Oncology Group ("GOG"), and ECOG (each of which is a government
sponsored cancer research network associated with the National Cancer Institute
of the National Institute of Health), involving patients with small volume
disease following surgery, IP administration of cisplatin has been shown to be
superior to intravenously administered cisplatin. However, cisplatin is not
approved for IP use. The high dose intensity achieved via IP administration and
the direct contact of drug with tumor cells and small volume tumor nodules is
believed to account for the effectiveness of this route. Following front-line
therapy, patients are monitored closely using physical examination, examination
of serum levels of CA-125, CT scans of the abdomen and pelvis, and often with
repeat surgical or laparoscopic exploration. Unfortunately, most patients with
advanced ovarian cancer are not cured with front-line treatment and the
development of platinum resistant recurrent disease within the peritoneal cavity
is common.
FIGURE 3. OVARIAN CANCER MANAGEMENT
[OVARIAN CANCER MANAGEMENT CHART]
When patients are shown to have recurrent disease, second-line therapies
are typically administered. Although IP administration of several agents has
been evaluated, there are no drugs approved in the United States for use in this
manner. As mentioned above, IP cisplatin has been shown to be quite effective as
front-line therapy involving patients with small volume disease. Doxorubicin, an
anthracycline known to be effective in the treatment of patients with ovarian
cancer when administered intravenously, was evaluated for IP administration;
however, due to this contact toxicity of this compound and the complications
that were observed, the drug is considered to be inappropriate for IP use.
Valstar(TM) is also an anthracycline which, in comparison to doxorubicin,
is associated with considerably less contact toxicity. Anthra's Phase I/II study
of IP Valstar(TM) use demonstrated that the drug is safe and well tolerated at
high dose levels, and produced preliminary evidence of drug activity in a
heavily pre-treated group
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of patients. Anthra is sponsoring a Phase III clinical trial in the United
States and Canada involving patients with small volume disease following
treatment with platinum and paclitaxel. The Company plans to launch a European
Phase III study of IP Valstar(TM) in fiscal year 1999. Data from these studies
is expected to support supplementary regulatory filings for this claim by fiscal
year 2001. If IP Valstar(TM) is approved by the FDA, Valstar(TM) can then be
marketed to the approximately 300 gynecological oncologists in the United States
and to a similar target audience in Europe. See "-- Valstar(TM): Licensing
Agreements."
VALSTAR(TM) IN PATIENTS WITH PROSTATE CANCER
In the United States, over 184,500 new cases of prostate cancer are
diagnosed each year and an estimated 39,200 deaths occurred from the disease in
1996. The risk of being diagnosed with prostate cancer increases with age and
the disease accounts for over 80% of the cancers diagnosed in men over the age
of 65. As a result of early detection screening procedures, including the use of
serum PSA (Prostate Specific Antigen) levels, approximately 60% of patients are
diagnosed when the disease is localized, that is, confined within the prostate
gland. Surgical prostatectomy (complete surgical removal of the prostate) was
traditionally considered by many experts to be the definitive treatment for
localized disease. However, due to the variable natural history of localized
prostate cancer and questions regarding the long-term efficacy of surgical
therapy, over the past five years, a strategy of "watchful waiting" has been
advocated by some experts. This approach entails careful observation of patients
with pathologically proven prostate cancer followed by definitive therapy when
the patient is considered to be at high risk of having progressive disease. As
depicted in Figure 4, a significant controversy regarding the optimal therapy
for localized prostate cancer has emerged, and the contrast of the foregoing
approaches has led a number of physicians and patients to seek alternative
therapies including external beam radiation therapy, brachytherapy (implantation
of radioactive seeds within the prostate gland), and cryotherapy (freezing of
the gland). Patients and physicians have found themselves at a crossroads having
to choose between either no treatment or a variety of forms of therapy
associated with significant side effects and compromised quality of life.
FIGURE 4. PROSTATE CANCER TREATMENT DILEMMA
[PROSTATE CANCER TREATMENT CHART]
Anthra and others have viewed this treatment dilemma as a possible
opportunity for treatment by way of a direct injection of therapeutic agents
within the prostate gland. In-vitro sensitivity studies have demonstrated
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the activity of Valstar(TM) against prostate cancer and studies of direct
intraprostatic injection of Valstar(TM) in dogs has established the feasibility
of this approach. Anthra is working with its investigators to finalize the
protocol and begin patient enrollment in a Phase I study of intraprostatic
Valstar(TM) in fiscal year 1999. Subsequent studies may be initiated pending the
results of this Phase I study.
VALSTAR(TM): MARKET
The Company has researched the historical incidence of the diseases for
which the Company is currently conducting trials for Valstar(TM) based on
publicly available information and reports prepared for the Company by MedProbe,
including a report summarizing the results of a survey of 1.5% (124) of office
and hospital based urologists reported to be members of the AMA. Although
precise patient data is not published and can vary significantly from year to
year, based on the foregoing research and certain assumptions made by the
Company, including the estimated cost of treating each of the estimated number
of patients with Valstar(TM), the Company estimates that the potential market
for Valstar(TM) in the United States could approximate nearly $600 million per
annum. This estimate is based on the following historical data, assumptions and
estimates: an average of approximately 5,000 to 9,000 patients per year are
estimated as having been diagnosed with carcinoma in-situ that is refractory to
BCG therapy, and the Company's estimate of the cost of treatment of this type of
cancer utilizing Valstar(TM) is $7,200 per patient; an average of approximately
180,000 patients per year are estimated as having had a TURB procedure
performed, and the Company estimates that an adjunctive treatment utilizing
Valstar(TM) would cost $1,200 per patient; an average of approximately 10,000
patients per year are estimated as having been diagnosed with small volume
ovarian carcinoma refractory to front-line treatment, and the Company's estimate
of the cost of treatment of this type of cancer utilizing Valstar(TM) is $9,000
per patient; an average of approximately 184,500 patients per year historically
have been diagnosed with organ-confined prostatic carcinoma, and the Company's
estimate of the cost of treatment of this type of cancer utilizing Valstar(TM)
is $1,200 per patient; and the estimated potential market for Valstar(TM) of
approximately nearly $600 million per annum assumes 100% of these patients
utilizes Valstar(TM) with the foregoing costs of treatment. No assurance can be
given by the Company that this estimated market for Valstar(TM) will be
achieved.
VALSTAR(TM): DRUG MANUFACTURING AND FINISHING
Valstar(TM) is or has been manufactured in bulk powder form for the Company
by Gensia Sicor in Rho (Milan), Italy, and by Omnichem in Louvain-la-Neuve,
Belgium.
In June 1991, the Company entered into an Exclusive Supply Agreement with
Omnichem for the manufacture of Valstar(TM) Drug Substance, part of which
terminated according to its terms in 1994. Following such termination, Anthra
had the right to contract for the manufacture of Valstar(TM) Drug Substance with
any party of its choice. However, for a period of 10 years from the date of such
termination, Omnichem has a right of last refusal to supply Valstar(TM) Drug
Substance on the same terms, including price, as those offered by a third party
supplier.
In September 1997, the Company entered into a Supply Agreement with Gensia
Sicor for the manufacture of Valstar(TM) Drug Substance (the "Gensia Sicor
Agreement"). In accordance with the terms of the Gensia Sicor Agreement, Gensia
Sicor supplied to Anthra in 1997 certain validation batches of Valstar(TM) Drug
Substance in return for payments aggregating $570,000, for purposes of
facilitating Anthra's United States and European regulatory approval processes
for Valstar(TM). Following the attainment of regulatory approval for Valstar(TM)
for commercial sale, Gensia Sicor is obligated to manufacture and supply
Valstar(TM) Drug Substance for Anthra in accordance with the terms and
conditions of the Gensia Sicor Agreement. Anthra's price for Valstar(TM) Drug
Substance shall be as set forth in the Gensia Sicor Agreement. In addition,
Anthra has the obligation to make certain payments to Gensia Sicor upon the
attainment of certain milestones in connection with the regulatory approval
process for Valstar(TM). Subject to certain limitations, the term of the Gensia
Sicor Agreement expires 10 years from the date of the first regulatory approval
for Valstar(TM).
Gensia Sicor has submitted to the FDA, and will submit to the appropriate
regulatory authorities in Europe, its Drug Master File with respect to
Valstar(TM), which includes, among other information, the Drug
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Establishment Registration Number, address of manufacturer, information
regarding the characterization of the drug substance, analytical specifications,
manufacturing flow sheet, production and process controls, evidence of chemical
structure, and characterization of reference standards and stability data.
Omnichem has submitted to the Company, which has in turn submitted to the FDA,
information similar to that which Gensia Sicor submitted to the FDA.
Release testing and stability testing of Valstar(TM) Drug Substance
produced by Omnichem has been performed under contract to Anthra by Ben Venue,
while release testing and stability testing of Valstar(TM) Drug Substance
produced by Gensia Sicor is performed by the manufacturer.
Valstar(TM) Drug Product is purchased from Ben Venue, and the Company is
currently negotiating the terms and conditions of a written supply agreement
with Ben Venue. Under the terms of its agreements with Medeva, Nycomed, and
Almirall, Anthra will be the exclusive provider of Valstar(TM) Drug Product for
post-approval marketing. See "-- Valstar(TM): Licensing Agreements."
VALSTAR(TM): COMPETITION
Anthra has designed its clinical and commercial development programs to
maximize the market competitiveness of Valstar(TM). At present, two therapeutic
agents are registered for IVe administration in the United States: the
chemotherapeutic drug thiotepa and the immunotherapeutic biological BCG.
Thiotepa is an older drug that is considered to have limited efficacy in
treatment of refractory bladder cancer. BCG is the definitive agent for
treatment of carcinoma in-situ, and is used for prophylactic IVe therapy to
supplement surgical resection of papillary tumors involving patients with
aggressive forms of the disease. Two other chemotherapeutic drugs marketed in
the United States, doxorubicin and mitomycin, are considered to be active when
administered by the IVe route, but neither is approved for IVe use by the FDA.
Clinical studies of immunotherapy with interferon administered intravesically,
Photofrin for use with photodynamic therapy, and the experimental oral agent
bropirimine, have demonstrated only limited utility for these agents in the
treatment of bladder cancer. Keyhole limpet hemocyanin is a developmental agent
that is being tested for activity against superficial bladder cancer as a
replacement for BCG.
Anthra's pivotal clinical studies in the United States were conducted using
patients who had failed to respond to or recurred following treatment with BCG.
At present, the majority of refractory patients are treated with surgical
cystectomy, although many patients refuse to undergo the procedure. For lack of
an appropriate alternate therapy, some urologists recommend bladder salvage IVe
therapy with non-approved agents. The FDA has designated Valstar(TM) an Orphan
Drug for treatment of refractory carcinoma in-situ. Thus, if approved,
Valstar(TM) will have protection from competition in this market for seven years
from the date of approval. See "Business -- Government Regulation."
If the results of Anthra's ongoing Phase III study of IVe Valstar(TM)
administered immediately following transurethral resection of the bladder are
positive, the data could provide the basis for a supplemental claim covering a
novel therapeutic approach. Although European studies have shown that mitomycin
is active in this clinical setting, this drug is not approved for IVe
administration in the United States. BCG is not a potential competitor for
peri-surgical therapy because administration of a live bacterial culture
immediately following surgery poses unacceptable risks.
The competitive environment for IVe Valstar(TM) in Europe is more
complicated because, in addition to BCG and thiotepa, mitomycin, epirubicin, and
doxorubicin are approved for IVe administration. None of these drugs, however,
has been rigorously evaluated in clinical studies for treatment of refractory
superficial bladder cancer and no agent has been registered based on a claim of
activity in a refractory patient population. Because the data from Anthra's
pivotal clinical trials involving patients with refractory disease in the United
States and Europe (which formed the basis for the Company's filing with the EMEA
for approval to market Valstar(TM) in Europe), comprise one of the largest
studies of a well-characterized refractory population, Anthra believes
Valstar(TM) will be competitive in the European market if approved.
Although several studies have shown that chemotherapeutic agents such as
cisplatin are active when administered intraperitoneally, no agent is approved
in either Europe or the United States for IP administra-
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tion. Anthra views this as an opportunity for Valstar(TM). Several agents have
been approved for treatment of refractory ovarian cancer via systemic
administration, including paclitaxel (Taxol(R)), which was originally registered
for second line therapy but is used increasingly in first line combination
therapy with platinum agents, topotecan and tamoxifen. Taxol(R) is being
evaluated in GOG trials for IP administration. Altretamine, which is taken
orally, is marketed in the United States for treatment involving patients with
refractory ovarian carcinoma. Anthra's Phase III study is comparing the activity
of IP Valstar(TM) and oral altretamine involving patients who have failed to
respond following therapy with platinum compounds and paclitaxel.
VALSTAR(TM): PROPRIETARY POSITION
Patent protection for Valstar(TM) as a NME expired in 1994. Anthra's
management believes it can maintain a strong proprietary position for the drug
based on three platforms. First, it will seek Orphan Drug status for Valstar(TM)
in specific disease indications; FDA designated Valstar(TM) an Orphan Drug for
treatment of refractory carcinoma in-situ in 1994 and Anthra will apply for
designation in other appropriate indications. Second, Anthra has proprietary
know-how in the manufacture and formulation of the drug. Finally, Valstar(TM)
will receive protection from generic competition for five years following
approval under provisions of The Drug Price Competition and Patent Term
Restoration Act of 1984 as amended (the "Waxman-Hatch Act"). This protection
does not, however, apply to full NDAs. Moreover, Congress may consider
amendments to the Waxman-Hatch Act that could affect the requirements for and
timing of generic drug approvals. In Europe, drugs approved via the centralized
procedure, that is, through the EMEA, are granted protection from generic
competition for a ten year period from the date of approval.
Pursuant to an Agreement with Dana-Farber, dated November 6, 1990 (the
"Dana-Farber Agreement"), Anthra acquired exclusive licensing rights to
Valstar(TM) for both in and outside of the United States. Upon the termination
of such exclusive licensing rights in the United States under the Dana-Farber
Agreement, Dana-Farber would grant the Company non-exclusive licensing rights
for the remaining term of the agreement. Under the Dana-Farber Agreement, Anthra
was given the right to file an NDA or IND for Valstar(TM) and has the obligation
to use best efforts to commercially develop Valstar(TM). The Company is liable
to Dana-Farber for annual royalty fees based on net sales, if any, as defined in
the Dana-Farber Agreement. The Company agreed to pay Dana-Farber a minimum
royalty of $15,000 for each 12-month period commencing on the anniversary of an
NDA approval in the United States of Valstar(TM). The obligation to pay minimum
royalties shall cease upon the termination of the Dana-Farber Agreement. Absent
any default, the Dana-Farber Agreement terminates in July 1999 or upon 90 days
notice by Anthra.
VALSTAR(TM): LICENSING AGREEMENTS
Nycomed
In October 1997, the Company entered into an Exclusive License, Sale and
Distribution Agreement with Nycomed for the sale and distribution of Valstar(TM)
for three indications in Europe generally, excluding Spain and Portugal, but
including the Commonwealth of Independent States, Russia, parts of Eastern
Europe and, subject to certain conditions, an option with respect to China (the
"Nycomed Agreement"). At that time, Nycomed also purchased 300,000 shares of the
Company's Series D Convertible Preferred Stock for $4.5 million. The Nycomed
Agreement provides, subject to certain restrictions and limitations, for future
payments by Nycomed to Anthra aggregating up to $2 million based on the
achievement of certain milestones. In connection with these payments, Nycomed
will receive an option to purchase up to an aggregate of 66,666 shares, subject
to certain conditions, of either the Company's Series D Convertible Preferred
Stock or Common Stock at a price of $15 per share, which options will expire in
accordance with the Nycomed Agreement. Upon making a certain payment under the
Nycomed Agreement, subject to certain conditions, Nycomed will receive an
additional option to purchase that number of shares of either Anthra's Common
Stock or Series D Convertible Preferred Stock that can be purchased for $1
million at the price per share as determined by a formula based on the market
price of the shares at the time of exercise, which options will expire in
accordance with the Nycomed Agreement. Subject to certain conditions, the
Nycomed Agreement requires that Anthra prepare and file applications for
regulatory approval for Valstar(TM) for the three indications in the countries
within the Nycomed territory. Subject to certain conditions, the Nycomed
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Agreement also provides for Anthra to supply Valstar(TM) Drug Product to Nycomed
at a price specified in the Nycomed Agreement. Unless earlier terminated
pursuant to its provisions, the Nycomed Agreement has an initial term of 10
years from the date in which the first major European Union member (other than
Spain and Portugal) grants the technical approvals for any indication for
Valstar(TM).
Medeva
In July 1997, the Company entered into the Medeva Agreement for the sale
and distribution of Valstar(TM) in the United States territory for two
indications. The Medeva Agreement provides for an initial non-refundable payment
of $8 million to Anthra which was paid on signing, and, subject to certain
restrictions and limitations, potential future milestone payments aggregating up
to approximately $15.1 million, of which the Company received $2.1 million in
September 1998, and potential future license fee payments aggregating up to
approximately $3 million (subject to certain offsets by Medeva for funds Medeva
may advance to Anthra for the continued development of Valstar(TM), costs
incurred by Medeva to bring certain actions for infringement, and certain losses
suffered by Medeva in third-party actions in connection with the sale of
Valstar(TM)), each based upon the achievement of certain milestones. In
consideration of, among other things, the aforementioned payments, Anthra has
granted to Medeva a nominal ownership interest in the proprietary rights to
Valstar(TM) as exploited in the United States and certain of the proceeds to the
Company resulting therefrom. Upon Anthra's achievement of a certain future
milestone under the Medeva Agreement and its receipt from Medeva of the payment
related thereto, Anthra will be obligated to make a $300,000 payment to the
financial intermediary that introduced Anthra to Medeva.
The Medeva Agreement also provides for the payment of royalties to the
Company based on the net sales of Valstar(TM) sold by Medeva. In addition, the
Company will supply Valstar(TM) Drug Product to Medeva at a price specified in
the Medeva Agreement.
The Medeva Agreement specifies that in the event the Company is unable to
complete the development of Valstar(TM) for certain indications due to lack of
funds, Medeva has the right to advance the necessary funds to the Company, which
advances may be set off by Medeva at a specified rate against its payments under
the Medeva Agreement, which would reduce payments to the Company thereunder. If
Anthra is unable to supply Valstar(TM) to Medeva on a timely basis as provided
in the Medeva Agreement, Anthra shall be obligated, subject to certain
restrictions and limitations, to pay liquidated damages to Medeva based on the
number of days that such supply is delayed up to a maximum amount of $450,000
per order. In the event that Anthra becomes obligated to pay Medeva liquidated
damages in a certain amount as specified in the Medeva Agreement, or is the
subject of a bankruptcy or similar proceeding, then Medeva shall have the right
to manufacture Valstar(TM) for the term of the Medeva Agreement. Subject to
certain exceptions as set forth in the Medeva Agreement, Medeva shall be limited
to the foregoing rights in the event Anthra is unable to supply Valstar(TM) on a
timely basis.
The Company may be entitled to receive additional payments for the ovarian
cancer indication, dependent upon the outcome of negotiations, which are
scheduled to be undertaken in 1998.
In the event that the Company has not obtained approval to market
Valstar(TM) in the United States for either the refractory carcinoma in-situ
indication or the papillary tumor indication by December 31, 2002, Medeva has
the right to require the Company to issue to it such number of shares of Common
Stock equal to 20% of the outstanding voting equity securities of the Company at
the time of its exercise of such right.
Subject to certain conditions, the Medeva Agreement requires Anthra to
prepare and file an NDA and sNDA for Valstar(TM) for two indications, and
subject to agreement with Medeva, a third indication.
Unless earlier terminated pursuant to its provisions, the Medeva Agreement
has a term of not less than 12 years from the date of the first commercial sale
of Valstar(TM) in the United States territory.
Almirall
In April 1997, the Company entered into the Almirall Agreement for the sale
and distribution of Valstar(TM) for all indications in Spain and Portugal. At
that time, Almirall also purchased 67,819 shares of
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Anthra's Series D Convertible Preferred Stock for $750,000. The Almirall
Agreement provides for an initial licensing payment by Almirall of $200,000
which was paid on signing, and future payments aggregating up to $400,000 upon
the achievement of certain milestones. The Almirall Agreement also provides for
Anthra to supply Valstar(TM) Drug Product to Almirall at a price specified in
the Almirall Agreement. The Almirall Agreement requires Anthra to conduct all
clinical trials required for the submission of applications for regulatory
approval for Valstar(TM) for at least two indications, and to file the
registrations in Spain and Portugal. Unless earlier terminated pursuant to its
provisions, the Almirall Agreement has an initial term of 10 years from the date
of the first commercial sale of Valstar(TM) in Spain.
Schering AG, Germany
In July 1996, the Company converted the Development Agreement into the
Support Agreement. The Support Agreement provides for a payment by Schering AG,
Germany to Anthra of $3.5 million in consideration of such conversion of the
Development Agreement and the issuance by Anthra to Schering AG, Germany of
200,000 shares of Anthra's Series D Convertible Preferred Stock, which was
subsequently converted by Schering AG, Germany into Common Stock. Such payment
was received by the Company and recorded as $2.2 million toward the purchase of
the 200,000 shares of Series D Convertible Preferred Stock and the remaining
$1.3 million of the payment as other revenue upon conversion to the Support
Agreement. The Support Agreement provides for royalties to be paid by Anthra to
Schering AG, Germany based on the net sales of Valstar(TM). Unless earlier
terminated pursuant to its provisions, the Support Agreement will expire seven
years after the date of the commercial launch of Valstar(TM) in the United
States, Germany or the United Kingdom.
BONEFOS(R): AN ORAL AGENT FOR OSTEOLYTIC COMPLICATIONS OF METASTATIC CANCER
Lytic bone disease is a medical condition that results from the
establishment and growth of metastases emanating from a variety of cancers,
including breast, lung, and multiple myeloma. The pathophysiologic basis of the
condition is the stimulation of a population of normal bone cells (osteoclasts)
relative to another population of bone cells (osteoblasts). Normal functioning
of bone depends on osteoclasts and osteoblasts acting in concert. Osteoclasts
mediate destruction of bone and osteoblasts are responsible for bone growth and
mineral production. The interplay between destruction and formation is integral
to bone re-modeling and various metabolic functions including calcium
regulation. When cancer metastasizes to bone, preferential stimulation of
osteoclasts leads to bone resorption and breakdown. As depicted in Figure 5,
lytic bone metastases are responsible for a clinical spectrum of diseases,
including establishment and progression of metastases leading to complications
including pain, pathological fracture and, in the terminal stages, hypercalcemia
(elevated blood calcium levels).
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FIGURE 5. BONEFOS(R) IN THE MANAGEMENT OF LYTIC BONE DISEASE
[OSTEOLYTIC BONE METASTASES GRAPH]
Bonefos(R) (clodronate) is an orally active bisphosphonate compound that
blocks bone resorption through osteoclast inhibition. High doses of
bisphosphonates are required to control lytic bone metastases resulting from
cancer. Due to significant gastrointestinal toxicity, most bisphosphonates
cannot be administered orally at high doses, so the products currently marketed
in the United States for the management of lytic bone metastases must be
administered intravenously. In contrast, clinical studies and more than 12 years
of marketed use in Europe have shown that Bonefos(R) is effective and well
tolerated when administered orally. Bonefos(R) is currently approved in 56
countries for the treatment of hypercalcemia and complications from lytic bone
disease.
Anthra has entered into the Bonefos Option Agreement and intends to
exercise its option thereunder to enter into the Bonefos Agreements, which
provide for the acquisition of development and marketing rights for Bonefos(R)
for the hypercalcemia and lytic bone disease indications in the United States.
See "-- Bonefos(R): Proprietary Position; -- Bonefos Option Agreement."
Bonefos(R) has been on the market in Europe and the rest of the world since
1985, with worldwide sales of approximately $150 million in 1997. Upon the
execution of the Bonefos Agreements pursuant to the Company's exercise of the
aforementioned option, Anthra's development program for Bonefos(R) will target
two potential claims for the drug: maintenance of normal blood calcium in
hypercalcemic patients; and treatment of lytic bone disease. Table II summarizes
this proposed program.
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TABLE II. SUMMARY OF PROPOSED BONEFOS(R) CLINICAL DEVELOPMENT PROGRAM
INDICATION/TREATMENT TYPE RATIONALE STATUS
------------------------- ----------------------------------- -----------------------
Hypercalcemia/Oral - Approved in 56 countries for - United States Phase
treatment of hypercalcemia III study ongoing;
- Large safety and efficacy dossier Orphan Drug
designation
---------------------------------------------------------------------------------------
Lytic bone disease/Oral - Approved in 56 countries for - United States Phase
treatment of lytic bone disease III study proposed
- Large safety and efficacy dossier
---------------------------------------------------------------------------------------
Once the Company exercises its option to enter into the Bonefos Agreements,
it will implement a Phase III randomized clinical trial to evaluate the efficacy
of Bonefos(R) taken daily orally for maintenance of normal blood calcium levels
in patients who have received acute treatment with intravenous drugs for
hypercalcemic complications of metastatic disease. The Company believes that
about 50% of patients who respond to acute treatment relapse with hypercalcemia
and require acute treatment again. A subsequent Phase III randomized study will
compare the activity of monthly treatment with pamidronate (Aredia(R))
administered as an intravenous infusion and daily treatment with Bonefos(R)
taken orally for controlling lytic bone disease in patients with metastatic lung
or breast cancer. Intravenous treatment with Aredia(R) has been shown to reduce
the incidence of skeletal complications (fractures, surgery, radiotherapy and
pain), and the Company's management views the availability of an effective oral
agent as a significant opportunity. As the Company intends to exercise its
option to enter into the Bonefos Agreements on or prior to September 30, 1998,
Anthra expects to launch these studies in fiscal year 1999.
BONEFOS(R): MARKET
The oncology market for bone resorption inhibitors is young and growing
rapidly. For example, United States sales of Aredia(R) nearly doubled to $200
million in 1997 following its approval for the wider claim of management of
lytic bone disease. Bonefos(R) is both less costly and more convenient to
administer than Aredia(R), which must be given as a three-hour or 24-hour
infusion in a supervised setting and costs, according to Company estimates,
approximately $1,500 per monthly treatment. In comparison, Bonefos(R), an orally
administered drug, is currently priced at $300 per month in Europe. If
Bonefos(R) is approved, it will be marketed to the 9,000 clinical oncologists in
the United States.
The Company has researched the historical incidence of hypercalcemia and
the types of lytic bone disease in which Bonefos(R) is active based on publicly
available information. Although precise patient data is not published and can
vary significantly from year to year, based on the foregoing research and
certain assumptions made by the Company, including the estimated costs of
utilizing Bonefos(R) for the treatment of these maladies using each of the
estimated number of patients, the Company estimates that the potential market
for Bonefos(R) in the United States could approximate nearly $900 million per
annum. This estimate is based on the following historical data, assumptions and
estimates. Between 500,000 to 700,000 people each year are reported to have died
from cancer, and of these people, between two-thirds to three-quarters are
reported to have developed bone metastases during the later stages of this
disease; based on the foregoing, the Company has assumed approximately 450,000
patients per year will develop bone metastases. The Company's estimate of the
cost of treatment of this malady utilizing Bonefos(R) is $1,825 per patient.
Hypercalcemia frequently occurs in the setting of widespread osteolytic bone
lesions, and the Company has thus assumed that an additional 50,000 patients per
year with bone metastases not receiving treatment will develop hypercalcemia.
The Company's estimate of the cost of treatment of this malady utilizing
Bonefos(R) is $900 per patient. The potential market for Bonefos(R) of
approximately nearly $900 million per annum assumes 100% of these patients
utilize Bonefos(R) with the foregoing costs of treatment. No assurance can be
given by the Company that this estimated market for Bonefos(R) will be achieved.
BONEFOS(R): COMPETITION
Two bisphosphonate compounds are marketed in the United States for
treatment of osteolytic complications due to malignancies: Aredia(R) is
considered the most active and has captured a significant and increasing
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share of this market; and Didronel(R) (etridronate) is used less because it has
been shown to inhibit bone regrowth as well as resorption. Both drugs require
intravenous administration for treatment of conditions associated with
malignancies. Two other bisphosphonates, tiludronate (Skelid(R)) and alendronate
(Fosamax(R)), are marketed in oral formulations for treatment of osteoporosis
and/or Paget's Disease, and several other compounds are in clinical development
for these non-malignant disease indications. If the companies developing and
marketing these drugs pursue additional claims for the hypercalcemia and/or
lytic bone disease indications, these products could be potential competitors to
Bonefos(R).
BONEFOS(R): PROPRIETARY POSITION
Several patents for use and formulation of Bonefos(R) have been granted,
and are due to expire commencing in 2010 and ending in 2014. Bonefos(R) has
received Orphan Drug designation for the treatment of osteolysis (hypercalcemia)
and, therefore, may have market exclusivity for seven years from the date of
approval of the NDA for this indication.
BONEFOS(R): BONEFOS OPTION AGREEMENT
In December 1997, the Company entered into a term sheet (the "Bonefos
Agreement in Principle") with Berlex and Leiras Oy, affiliates of Schering AG,
Germany to acquire the rights to develop and exclusively market Bonefos(R) for
the hypercalcemia and lytic bone disease indications in the United States, and
for the related rights to purchase its requirements of Bonefos(R). Upon
execution of the Bonefos Agreement in Principle, the Company made a
nonrefundable payment to Berlex of $250,000 which was recorded as a research and
development expense. The Bonefos Agreement in Principle expired pursuant to its
terms.
On July 6, 1998, the Company entered into the Bonefos Option Agreement and,
in connection therewith, made a nonrefundable payment of $200,000. The Bonefos
Option Agreement grants the Company the option to enter into the Bonefos
Agreements, both of which have been fully negotiated, and such option may be
exercised by the Company on or prior to September 30, 1998, accompanied by an
additional nonrefundable payment of $800,000. The Company intends to exercise
this option prior to or on September 30, 1998, and enter into the Bonefos
Agreements. The Bonefos Agreements provide for payment from the Company to
Leiras Oy of $2.5 million on or before December 31, 1998, in consideration of
the rights to develop and exclusively market Bonefos(R), on a royalty-free
basis, for the hypercalcemia and lytic bone disease indications in the United
States and for the related rights to purchase its requirements of Bonefos(R).
The Bonefos Agreements have a term of 15 years from the date of their execution.
The Bonefos Agreements further provide that, for a period after the
acceptance for filing of the NDA for the first indication for Bonefos(R), Berlex
will have the option to acquire from the Company the exclusive right to market
Bonefos(R) in the United States for the hypercalcemia and lytic bone disease
indications for (i) a $6 million payment to the Company upon FDA approval of the
NDA for the hypercalcemia indication, (ii) an obligation to make a $15 million
payment to the Company upon FDA approval of the NDA (or sNDA) for the lytic bone
disease indication, and (iii) an obligation to make royalty payments to the
Company. In addition, if Berlex exercises the option, it may elect to develop
Bonefos(R) in the United States for prevention of lytic bone disease. Upon the
approval of an sNDA for such indication, Berlex will make certain royalty
payments to the Company.
In the event Berlex does not exercise the aforementioned option, the
Bonefos Agreements provide that the Company would maintain the aforementioned
exclusive right to market Bonefos(R) in the United States. In such event, the
Bonefos Agreements provide for a supply obligation for a minimum of fifteen
years from the date of execution, by Leiras Oy, the Schering AG, Germany
affiliate that developed Bonefos(R) and currently manufactures Bonefos(R) for
sale in Europe, in which Leiras Oy would have the exclusive right and obligation
to supply the Company with Bonefos(R) for sale in the United States at a price
specified in the Bonefos Agreements.
Under the Bonefos Agreements, Anthra is required to seek FDA approval of
Bonefos(R) for the hypercalcemia and lytic bone disease indications, and will
lose its license rights if it fails to file an NDA for Bonefos(R) for at least
one indication by February 15, 2002, subject to certain conditions. The Company
must also meet certain financial conditions on an on-going basis or the Bonefos
Agreements may be terminated.
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GOVERNMENT REGULATION
The research, testing, manufacturing, labeling, marketing, distribution and
advertising of pharmaceutical products, such as the Company's proposed products
are subject to extensive regulation by governmental regulatory authorities in
the United States and other countries. The drug development and approval process
is generally lengthy, expensive and subject to unanticipated delays. The FDA and
comparable agencies in foreign countries impose substantial requirements on the
introduction of new pharmaceutical products through lengthy and detailed
preclinical and clinical testing requirements, sampling activities and other
costly and time-consuming compliance procedures. A new drug may not be marketed
in the United States until it has undergone rigorous testing and has been
approved by the FDA. The drug may then be marketed only for the specific
indications, uses, formulations, dosage forms and strengths approved by the FDA.
Similar requirements are imposed by foreign regulators upon the marketing of a
new drug in their respective countries. Satisfaction of such regulatory
requirements, which includes demonstrating to the satisfaction of the FDA that
the relevant product is both safe and effective, typically takes several years
or more depending upon the type, complexity and novelty of the product, and
requires the expenditure of substantial resources. Preclinical studies must be
conducted in conformance with the FDA's current Good Laboratory Practice
("cGLP") regulations. The Company's compounds require extensive clinical trials
and FDA review as new drugs. Clinical trials are rigorously regulated and must
meet requirements for FDA review and oversight, and requirements under current
Good Clinical Practice ("cGCP") guidelines. There can be no assurance that the
Company will not encounter problems in clinical trials which would cause the
Company, the FDA or another relevant regulatory body to delay or suspend
clinical trials. Any such delay or suspension could have a material adverse
effect on the Company's business, financial condition and results of operations.
The steps required before a drug may be marketed in the United States
include: (i) preclinical laboratory and animal tests; (ii) submission to the FDA
of an application for an IND exemption, which must become effective before human
clinical trials may commence; (iii) human clinical trials to establish the
safety and efficacy of the drug; (iv) submission of a detailed NDA to the FDA;
and (v) FDA approval of the NDA. In addition to obtaining FDA approval for each
product, each establishment where the drug is to be manufactured must be
registered with the FDA. Manufacturing establishments must comply with current
Good Manufacturing Practice ("cGMP") regulations and are subject to periodic
inspections by the FDA. Foreign manufacturing establishments manufacturing drugs
intended for sale in the United States must comply with the same cGMP
regulations and registration requirements as domestic establishments and are
subject to periodic inspection by the FDA or by local authorities under
agreement with the FDA.
Preclinical tests include laboratory evaluation of product chemistry and
animal studies to assess the metabolic and pharmacologic activity and potential
safety and efficacy of the product, including acute and chronic toxicity studies
and others. Preclinical tests must be conducted by laboratories that comply with
FDA regulations regarding cGLP. The results of preclinical tests are submitted
to the FDA as part of an IND, which must become effective before the sponsor may
conduct clinical trials in human subjects. Unless the FDA objects to an IND, the
IND becomes effective 30 days following its receipt by the FDA. There is no
certainty that submission of an IND will result in FDA authorization of the
commencement of clinical trials. In addition, either before or after approval of
an IND, the FDA can issue a clinical hold requiring that clinical trials be
stopped, either temporarily or permanently.
Clinical trials involve the administration of the investigational drug to
patients. Every clinical trial must be conducted under the review and oversight
of an institutional review board ("IRB") at each institution participating in
the trial. The IRB evaluates, among other things, ethical factors, the safety of
human subjects and the possible liability of the institution. The IRB has
continuing oversight of the protocols. There is no assurance that the IRB will
approve a study or not require protocol changes. Clinical trials are conducted
by qualified investigators (usually physicians within medical institutions)
selected by the sponsor of the trial to supervise the administration of the drug
and ensure that the investigations are conducted in accordance with FDA
regulations, including the general investigational plan and protocols contained
in the IND. The sponsor also has an independent obligation to monitor the trials
and ensure that all applicable legal requirements are satisfied, including
requirements to comply with FDA recordkeeping and safety reporting regulations.
Each protocol must be submitted to the FDA as part of the IND. The FDA's review
of a protocol, however, does not mean that the study will be regarded as showing
safety or effectiveness. Clinical trials typically are
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conducted in three phases, which generally are conducted sequentially, but which
may overlap. Clinical trials test for efficacy and safety, side effects, dosage,
tolerance, metabolism and clinical pharmacology. Phase I tests involve the
initial introduction of the drug to a small group of subjects, often healthy
volunteers, to test for safety, dosage tolerance, pharmacology and metabolism.
Phase I/II studies are early studies designed to evaluate safety and preliminary
activity of drugs in patients. Phase II trials involve a larger but still
limited patient population to determine the efficacy of the drug for specific
indications, to determine optimal dosage and to identify possible side effects
and safety risks. If a drug appears to be safe and efficacious in Phase II
evaluations, larger-scale Phase III trials are undertaken to evaluate the safety
and effectiveness of the drug, usually, though not necessarily, in comparison
with a placebo or an existing treatment. Certain provisions of the FDAMA have
clarified provisions of prior law governing clinical testing. For example, data
from one well-controlled Phase III clinical trial, together with confirmatory
evidence, may, at the discretion of the FDA, be deemed to establish
effectiveness, but the FDA is not required to depart from its usual requirement
of two Phase III trials in any particular case. Another provision of the FDAMA
establishes requirements regarding when the FDA must begin action in clinical
trial applications. There can be no assurance, however, that Phase I, Phase II
or Phase III testing will be completed successfully within any specified time
period, if at all. Furthermore, the FDA may suspend clinical trials at any time
if it decides that patients are being exposed to a significant health risk.
The results of the preclinical studies and clinical trials are submitted to
the FDA as part of an NDA for approval of the marketing of a drug for a specific
indication. The NDA also includes information pertaining to the chemistry,
formulation and manufacture of the drug and each component of the final product.
The NDA review process takes from one to two years on average to complete,
although reviews of treatments for cancer and other life-threatening diseases
may be accelerated. However, the process may take substantially longer if the
FDA has questions or concerns about a product. In general, the FDA requires at
least two adequate and well-controlled clinical studies demonstrating efficacy
in order to approve an NDA. The FDA may, however, request additional
information, such as long-term toxicity studies or other studies relating to
product safety or effectiveness. Notwithstanding the submission of such data,
the FDA ultimately may decide that the NDA does not satisfy its regulatory
criteria for approval. Finally, the FDA may require additional clinical tests
following NDA approval. There can be no assurance that the drugs the Company is
seeking to develop will prove to be safe and effective in treating or preventing
cancer. The development of such drugs will require the commitment of substantial
resources to conduct the preclinical studies and clinical trials necessary to
bring such compounds to market. Drug research and development by its nature is
uncertain. There is a risk of delay or failure at any stage, and the time
required and cost involved in successfully accomplishing the Company's
objectives cannot be predicted. Actual drug research and development costs could
exceed budgeted amounts, which could have a material adverse effect on the
Company's business, financial condition and results of operations.
The FDA has issued regulations intended to expedite the development,
evaluation, approval and marketing of new therapeutic products to treat
life-threatening and severely debilitating illnesses for which no satisfactory
alternative therapies exist. These regulations provide for early consultation
between the sponsor and the FDA in the design of both preclinical studies and
clinical trials. There can be no assurance that any products the Company may
develop will be eligible for evaluation by the FDA under these regulations. In
addition, there can be no assurance that any products, if eligible, will be
approved for marketing at all or, if approved for marketing, will be approved
for marketing sooner than would be traditionally expected. Regulatory approval
granted under these regulations may be restricted by the FDA as necessary to
ensure the safe use of the drug. In addition, post-marketing clinical studies
are required, and, if such drugs do not perform satisfactorily in such
post-marketing clinical studies, such drugs would likely be required to be
withdrawn from the market. The FDA also requires prior review of promotional
materials for drugs approved under these provisions. The FDAMA has also provided
a mechanism for identifying breakthrough drugs and for streamlining the
regulatory process. No assurance can be given that any of the Company's products
will qualify for the relevant provisions under the FDAMA with respect to such
mechanism.
The Prescription Drug User Fee Act of 1992, as amended, was enacted to
expedite FDA review and approval of new drugs by providing the FDA additional
funds through the imposition of user fees on sponsor companies of prescription
drugs. Such Act imposes three kinds of user fees: (i) a one-time fee for each
single-source prescription drug application submitted on or after September 1,
1992; (ii) an annual fee for each
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establishment that produces single-source prescription drugs; and (iii) an
annual fee for each single-source prescription drug product marketed. This
program was renewed by the FDAMA.
Anthra cannot predict when, if ever, it might submit for regulatory review
additional compounds currently under development or additional claims for
existing compounds. Once the Company submits its potential products for review,
there can be no assurance that FDA or other regulatory approvals for any
pharmaceutical products developed by Anthra will be granted on a timely basis,
if at all. The FDA and comparable agencies in foreign countries impose
substantial requirements on the introduction of new pharmaceutical products
through lengthy and detailed preclinical and clinical testing procedures, sample
testing and other costly and time-consuming compliance procedures. Clinical
trials are rigorously regulated. A new drug may not be marketed in the United
States until it has been approved by the FDA or marketed in foreign countries
until it has been approved by the appropriate regulatory agencies for such
countries. There can be no assurance that the Company will not encounter delays
or rejections during any approval process, or that the FDA or any other
applicable regulatory agency will not make policy changes during the period of
product development and FDA or other applicable regulatory agency regulatory
review of any submitted NDA or other appropriate documentation. A delay in
obtaining or failure to obtain such approvals would have a material adverse
effect on the Company's business, financial condition and results of operations.
Even if regulatory approval is obtained, the labeling would be limited as to the
indicated uses for which the product may be promoted or marketed. A marketed
product, its manufacturer and the facilities in which it is manufactured are
subject to continual review and periodic inspections. If marketing approval is
granted, the Company would be required to comply with FDA or other applicable
regulatory agency requirements for manufacturing, labeling, advertising, record
keeping and reporting of adverse experiences and other information. Even after
approval, marketed products are subject to continuing FDA review, and they can
be withdrawn from the market, or new limitations placed on their labeling,
marketing, distribution, manufacture, or use, if new side effects are discovered
or if the products are shown to be less effective than previously believed. In
addition, the Company would be required to comply with Federal and state
anti-kickback and other health care fraud and abuse laws, and similar foreign
laws, that pertain to the marketing of pharmaceuticals. Failure to comply with
regulatory requirements and other factors could subject Anthra to regulatory or
judicial enforcement actions, including, but not limited to, product recalls or
seizures, injunctions, withdrawals of product from the market, civil penalties,
criminal prosecution, refusals to approve new products and withdrawals of
existing approvals, as well as enhanced product liability exposure, any of which
could have a material adverse effect on the Company's business, financial
condition and results of operations.
Among the requirements for FDA product approval is that manufacturers
conform to the FDA's cGMP standards, which also must be observed at all times
following approval. An NDA will not be approved until the manufacturing
facilities have been inspected and found to be in compliance with cGMP
standards, and approvals can be withdrawn and other actions taken to prevent
continued manufacturing and distribution if a facility is found to be out of
compliance with cGMP standards or with the manufacturing provisions of the NDA
after approval. Accordingly, manufacturers must continue to expend time, money
and effort in production, record keeping and quality control to ensure
compliance with cGMP standards. Failure to so comply subjects the manufacturer
to possible FDA action, such as the suspension of manufacturing or seizure of
the product. The FDA may also request a voluntary recall of a product. Foreign
regulators also impose restrictions on drug manufacturers.
Pursuant to the Orphan Drug Act, the FDA may designate a drug intended to
treat a "rare disease or condition" as an Orphan Drug. A "rare disease or
condition" is one which affects less than 200,000 people in the United States,
or which affects more than 200,000 people but for which the cost of development
and distribution of a drug for treatment of such disease or condition will not
be recovered from sales of the drug in the United States. Upon approval of an
NDA for an Orphan Drug, such drug may be eligible for exclusive marketing rights
in the United States for designated and approved indications for seven years
from the date of approval by the FDA for such indication. Orphan Drugs may also
be eligible for Federal income tax credits for certain clinical trial expenses.
Orphan Drug status for Valstar(TM) for the treatment of carcinoma in-situ
of the bladder and for Bonefos(R) for the treatment of osteolytic bone
metastases has been granted. The Company may receive marketing
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exclusivity for an Orphan Drug only if it is the sponsor of the first NDA
approved for the drug for an indication for which the drug was designated as an
Orphan Drug prior to the approval of such NDA. Therefore, unlike patent
protection, Orphan Drug status does not prevent other manufacturers from
attempting to develop the drug for the designated indication or from obtaining
NDA approval prior to approval of the Company's NDA. If another sponsor's NDA
for the same drug and the same indication is approved first, that sponsor is
entitled to exclusive marketing rights if that sponsor has received Orphan Drug
designation for the drug. In that case, the FDA would be prohibited from
approving the Company's application to market the product for the relevant
indication for a period of seven years. If another sponsor's NDA for the same
drug and the same indication is approved first, but that drug has not been
designated as an Orphan Drug, the FDA would still be permitted to approve the
Company's NDA without the exclusivity provided by Orphan Drug status. Even if
the Company did receive Orphan Drug exclusivity, that does not prohibit the FDA
from approving the same drug manufactured by another sponsor if it is labeled
for a different indication (even if it can be used for the same indication) or
if it is clinically superior to the Orphan Drug in any respect. Moreover,
amendment of the Orphan Drug Act by the United States Congress and
reinterpretation by the FDA are frequently discussed. Therefore, there can be no
assurance as to the precise scope of protection that may be afforded by Orphan
Drug status in the future, or that the current level of exclusivity will remain
in effect. Failure to receive such exclusivity could have an adverse effect on
the Company's business, financial condition and results of operations.
In most cases, pharmaceutical companies rely on patents to provide market
exclusivity for the periods covered by the patents. See "Business-Products and
Markets." In the United States, the Waxman-Hatch Act permits an extension of
patents in certain cases to compensate for patent time expended during clinical
development and FDA review of a drug. In addition, the Waxman-Hatch Act
establishes a period of market exclusivity, independent of any patents, during
which the FDA may not accept or approve abbreviated applications for generic
versions of the drug from other sponsors, although the FDA may accept and
approve subsequent full NDAs for the drug. This applicable period of market
exclusivity for a drug containing an active ingredient not previously approved
is five years. There is no assurance that all or any of the Company's products,
if approved, will receive market exclusivity under the Waxman-Hatch Act. Failure
to receive such exclusivity could have an adverse effect on the Company's
business, financial condition and results of operations.
Health care reform legislation, if enacted, could result in significant
changes in the financing and regulation of the health care business. In
addition, legislation affecting coverage and reimbursement under Medicare,
Medicaid and other government medical assistance programs has been enacted from
time to time. The Company is unable to predict whether such legislation will be
enacted in the future or, if enacted, the effect of such legislation on the
future operation of the Company's business. Changes adversely affecting drug
pricing, drug costs reimbursement, and prescription benefits, among other
changes, could have a materially adverse effect on the Company's business,
financial condition and results of operations.
In 1993, legislation was adopted which established a very new and amended
system for the registration of medicinal products in the EU. One purpose of this
system is to provide an alternative to the essentially separate national
approval systems among EU members, a major obstacle to harmonization. One of the
most significant features of this new system is the establishment of EMEA. Under
this new system, an application for marketing authorization, broadly speaking,
may be submitted at either a centralized, a decentralized or a national level.
The centralized procedure is administered by the EMEA; this procedure is
mandatory for the approval of biotechnology products and available at the
applicant's option for other products. The centralized procedure provides for
the first time in the EU the ability to obtain marketing authorization that is
valid in all EU member states ("Member States"). The Company has chosen and has
been accepted for the centralized review procedure for its European regulatory
filings. However, there can be no assurance that this strategy will secure
regulatory approvals or the applications submitted by the Company. As of January
1995, a mutual recognition procedure is available at the request of the
applicant for all medicinal products that are not subject to the centralized
procedure, under the so-called "decentralized procedure." The decentralized
procedure became mandatory on January 1, 1998. The decentralized procedure
creates a new system for mutual recognition of national approvals and
establishes procedures for coordinated EU action on product suspensions and
withdrawals. Under this procedure, the holder of a national marketing
authorization for which mutual
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recognition is sought may submit an application to one or more Member States,
certifying that identical dossiers are being submitted to all Member States for
which recognition is sought. Within 90 days of receiving the application, each
Member State must decide whether to recognize the approval. The procedure
encourages Member States to work with applicants and other regulatory
authorities to resolve disputes concerning mutual recognition. If such disputes
cannot be resolved within the 90-day period, the application will be subject to
a binding arbitration procedure.
PRODUCT LIABILITY AND INSURANCE
The Company's business involves the risk of product liability claims. The
Company has not experienced any product liability claims to date. Although the
Company maintains general liability insurance, including clinical trials
coverage with coverage limits of $1 million per occurrence, an annual general
aggregate maximum of $1 million, and an annual products aggregate maximum of $3
million, with advertising and personal injury coverage of $1 million, there can
be no assurance that liability claims will not exceed such insurance coverage
limits, which could have a material adverse effect on the Company's business,
financial condition and results of operations, or that such insurance will
continue to be available to the Company on commercially reasonable terms, if at
all. The Company is in the process of increasing the annual products aggregate
maximum to $5 million; however, there can be no assurance given that the Company
will be able to obtain such increase on commercially reasonable terms, if at
all.
EMPLOYEES
At September 1, 1998, the Company employed 33 persons, with the majority
involved in clinical research activities. There are 26 employees located at the
Company's Princeton, New Jersey offices, and 7 in the United Kingdom office.
None of the Company's employees is represented by a labor union, and the
Company considers its relations with its employees to be positive. The Company
has experienced no work stoppages.
Many consultants are used in support of the Company's research and
development efforts.
Competition for technical personnel in the Company's industry is intense.
To date, the Company has been successful in recruiting and retaining qualified
personnel, but there can be no assurance that it will continue to be as
successful in the future. The Company's future success depends in part on its
continued ability to hire, assimilate and retain qualified personnel, including
through the issuance of its equity which would be dilutive to the Company's
shareholders.
PROPERTIES
In July 1997, the Company executed a sublease for the Company's principal
administrative and clinical offices of approximately 5,560 square feet located
in the Carnegie Center in Princeton, New Jersey. The monthly rent at the
Carnegie Center is $9,359, and the sublease expires on November 30, 1999. The
Company is currently preparing to relocate its clinical offices in Princeton,
New Jersey and in the interim may lease some space in addition to its Carnegie
Center location on a temporary basis.
The Company also leases approximately 1,635 square feet of office space for
its Anthra UK clinical offices at The Malt House in Princes Risborough, England.
The quarterly rent at The Malt House is L5,535 ($9,299 using a conversion factor
of 1.68 dollars for 1 British pound), and the lease expires in December 2000.
The Company believes that its facilities are adequate for its operations as
currently conducted and should be sufficient for the foreseeable future.
LEGAL PROCEEDINGS
As of the date of this Prospectus, there are no material legal proceedings
to which the Company is a party.
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MANAGEMENT
DIRECTORS AND EXECUTIVE OFFICERS
The following table sets forth certain information concerning the Company's
current Directors and executive officers.
NAME AGE POSITION WITH THE COMPANY
- ---- --- -------------------------
Mervyn Israel 65 Chairman of the Board and Secretary
Michael C. Walker 50 President, Chief Executive Officer and Director
Paul G. Gooding 63 Director
William Engbers(1) 55 Director
Karen Krumeich 44 Chief Financial Officer, Vice President - Finance
Robert Lippert 41 Senior Vice President - Marketing
Richard Onyett 51 Senior Vice President - Corporate Development
Allen L. Thunberg 51 Vice President - Pre-Clinical Development
Denise Webber 38 Vice President - Clinical and Regulatory Operations
- ---------------
(1) Member of the Audit Committee of the Board of Directors.
The business experience of each of the Directors and executive officers of
the Company is set forth below.
Mervyn Israel, Ph.D., Chairman of the Board and Secretary of Anthra since
1985, co-founded Anthra with Mr. Walker and is the inventor of Valstar(TM) and
numerous other anticancer drugs. Dr. Israel has spent over 40 years in the area
of cancer pharmacology, experimental therapeutics, and drug development.
Following the award of a Ph.D. degree in 1959 from the University of
Pennsylvania and postdoctoral appointments at the University of Michigan and
Harvard University, he was affiliated for many years with Dana-Farber, rising to
become Associate Chief for Drug Development in the Division of Pharmacology.
Since 1983, Dr. Israel has been associated with the University of Tennessee,
Memphis Health Science Center, where he holds joint appointments as Professor of
Pharmacology in the College of Medicine and Professor of Pharmaceutical Sciences
in the College of Pharmacy. Among other areas, Dr. Israel is an internationally
recognized expert on the chemistry and pharmacology of anthracycline anticancer
drugs.
Michael C. Walker has worked in the pharmaceutical industry for more than
25 years, starting in sales with Eli Lilly & Co. In the mid-1970's, Mr. Walker
joined Merck & Co., first managing two of Merck's primary products, then moving
into Corporate Development and Licensing. In the latter capacity, Mr. Walker was
instrumental in creating Merck's joint venture with Astra Pharmaceuticals. Mr.
Walker left Merck in 1983 to become Chief Executive Officer of Polydex
Pharmaceuticals in Toronto, Ontario, where he had the opportunity to apply his
own market expansion strategies to an existing small business. He also has
worked as a consultant to young pharmaceutical companies, specializing in
developing strategic solutions for the commercialization of both traditional and
biopharmaceutical products. Mr. Walker co-founded Anthra in 1985 and has been
President, Chief Executive Officer and a Director of Anthra since 1985. Mr.
Walker received a M.B.A. from Harvard University in 1973.
Paul G. Gooding, M.B., B.S., a Director of the Company since 1993, works
closely with Anthra's Clinical Development and Regulatory Affairs group, as well
as with the Company's Commercial Development team. Dr. Gooding has more than 30
years experience working in four multinational pharmaceutical companies,
primarily as Director of Clinical Research. From 1988 to 1993, Dr. Gooding was
employed by Sankyo U.S.A. Corporation, a subsidiary of Sankyo Company, Ltd.
(Japan), where he was responsible for the establishment and staffing of the
Medical Department and the supervision of the Medical Affairs, Clinical Research
and Regulatory Affairs Departments. At Sankyo U.S.A. Corporation, Dr. Gooding
held the position of Vice President and Medical Director. Dr. Gooding retired
from Sankyo U.S.A. Corporation in 1993, and since then has served as a
consultant to various companies in the pharmaceutical and scientific arena. In
addition to his considerable experience in developing clinical leads into
approved drugs, he has directed product acquisitions programs and managed in-
and out-licensing arrangements.
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William Engbers was elected a Director of Anthra in December 1997. Mr.
Engbers joined Allstate Insurance Company in 1989, where he is currently
Director of Venture Capital in Allstate's private equity group. Before that, he
was Chairman of the Board of Plant Genetics Inc. Mr. Engbers has been a venture
capitalist since 1981 and has served as a Director or Chairman of over two dozen
venture capital sponsored companies. He is currently a Director of LaJolla
Pharmaceuticals Company and DM Management, Inc. (both public companies), and
seven privately-held corporations.
Karen Krumeich, Chief Financial Officer and Vice President -- Finance,
joined Anthra in 1998, and is responsible for all accounting, finance and
treasury functions. Ms. Krumeich has worked in the healthcare industry for over
20 years specializing in finance and administration. Prior to joining Anthra,
she worked for Bristol-Myers Squibb from 1995 to 1998 as Director of Health
Systems Management in the Worldwide Franchise Management division, responsible
for international strategic business planning and managed care marketing. Ms.
Krumeich has an extensive background in the start-up and the development of
financial and cost control systems from her experience as Chief Financial
Officer of a pharmacy benefits management company, Pharmacy Direct Network, from
1994 to 1995, and as Vice President of Finance for the pharmacy division of
GranCare, a national long-term care and home healthcare company, from 1991 to
1994. Ms. Krumeich has a B.S. in Pharmacy from the University of Toledo, with
post graduate studies in accounting and finance.
Robert Lippert joined Anthra as Senior Vice President -- Marketing in 1998,
after 23 years of diversified pharmaceutical/healthcare experience. Mr. Lippert
will be responsible for all commercial operations at Anthra including the launch
of Valstar(TM). He was previously employed by Medeva Pharmaceuticals from 1997
to 1998 as Vice President Institutional Business, and from 1993 to 1997 as
Senior Vice President Marketing and Business Development at International
Medication Systems, Limited, a division of Medeva PLC. Prior to Medeva, Mr.
Lippert was employed by Ethex/KV Pharmaceuticals from 1991 to 1993, and by
Ohmeda Pharmaceuticals (Baxter) from 1984 to 1991, where he held numerous senior
positions in Business Development, Marketing, and Finance. Mr. Lippert received
his B.A. in Animal Biology and History from the University of Wisconsin. He also
holds a B.B.A. in Business Administration/Finance from the University of
Wisconsin, Milwaukee, and an M.B.A. in Marketing from Marquette University.
Richard Onyett has worked in the pharmaceutical industry for over 25 years
as a marketing and business development specialist. From 1970 to 1981, he worked
in overseas country management and strategic marketing at ICI Pharmaceuticals,
where he managed several major product ranges. He then worked for SmithKline and
French Laboratories from 1981 to 1990, initially as head of new products and
subsequently in charge of business development. In 1990, he was a founder of The
Kite Organization, a healthcare consultancy. Since 1992, his consultancy firm,
Camas Partners, has provided commercial development services to a number of
medical research institutions and biopharmaceutical companies in the United
States and Europe. All existing contractual obligations of Camas Partners have
now been completed. In 1995, Mr. Onyett founded and became a director of Cambrio
Group plc, and he is a director of Rio Pharmaceuticals Limited. In September
1997, Mr. Onyett joined Anthra as Senior Vice President -- Corporate Development
with primary responsibility for the Company's corporate development. In addition
to his corporate development responsibilities, he manages Anthra's U.K.
operations, including clinical development. Mr. Onyett has a B.Sc. from the
University of Nottingham and an M.Sc. in Virology from the University of
Birmingham.
Allen L. Thunberg, Ph.D., Vice President -- Pre-Clinical Development, is
responsible for all aspects of pre-clinical research and development and
manufacturing at Anthra. He joined the Life Sciences Group at Eastman Kodak in
1977, where he worked initially in clinical diagnostics and later in
pharmaceuticals. In 1987 he transferred to Eastman Pharmaceuticals, a newly
formed Division of Eastman Kodak, where he established discovery programs in
immunology and targeted therapy, and negotiated and managed collaborative
research and development programs with several biotechnology companies. In 1988,
following Kodak's acquisition of Sterling Drug, he established and managed a
research and development department with broad-based discovery and development
responsibilities, and continued to serve as technical/business liaison for six
collaborative biotechnology programs. Following the sale of Sterling Drug to
Sanofi in 1994, Dr. Thunberg worked as biopharmaceutical consultant, then joined
Anthra in 1996. Dr. Thunberg received his B.S. from North Dakota State
University and his Ph.D. from The Rockefeller University, and completed
post-doctoral studies at The Johns Hopkins University.
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Denise Webber, Vice President -- Clinical and Regulatory Operations, is
responsible for the oversight of the clinical trials and regulatory approval
processes and for the clinical and technical support of Marketing and Sales for
the commercialization of Anthra's therapeutic products. Ms. Webber was appointed
to her current position in September 1998. She was Vice President -- Medical
Affairs of the Company from April 1998 until September 1998 and the Director of
Clinical and Data Operations of Anthra, responsible for Anthra's clinical
studies, from 1994 to 1998. Ms. Webber has seven years experience in the design
and management of clinical trials of oncology products. Prior to joining Anthra
in 1994, she was Manager for Medical Affairs at Cytogen Corp. from 1992 to 1994.
Ms. Webber, a Certified Nuclear Medicine Technologist, has a B.S. from Loras
College.
RECENT CHANGES IN THE CONSTITUTION OF THE BOARD OF DIRECTORS
Membership on the Board of Directors has been reduced to four, down from
seven when Amendment No. 3 to the Registration Statement of which this
Prospectus forms a part was filed in May 1998. In the case of Messrs. Dow and
Schiller, neither person assigned in his letter of resignation a specific reason
for his resignation. The Company understands that in each case the reason was
not Company-specific, nor the result of a dispute relating to the Company's
business directions. The Company knows of no plans by either Messrs. Dow or
Schiller or their affiliates to dispose in the near term his or their stock in
the Company or otherwise to diminish their support for the Company and its
prospects. In the case of Dr. Gulfo, who elected to pursue opportunities with an
early stage firm, he has agreed to continue as a consultant during a transition
period, including rendering services to assist the Company in attempting to
secure final NDA approval/labeling and obtain approval of the marketing
materials for a launch of Valstar(TM), and identifying a suitable replacement
and providing transition training.
KEY EMPLOYEE
The Company has identified the following additional individual as a key
employee.
Philip Wood, FFPM, Medical Director -- Europe, is responsible for the drug
development program of the Company in Europe. Dr. Wood obtained his medical
degree in Britain and worked in several British hospitals, gaining broad
experience in general medicine and developing his interests in pediatrics and
obstetrics, before entering general medical practice in the south of England. In
1975, he entered the pharmaceutical industry and since then has undertaken posts
of increasing responsibility, including Medical Director for Bristol-Myers
Squibb UK and Medical Director for Wellcome UK. Dr. Wood is a Member of the
Royal College of General Practitioners and a Fellow of the Faculty of
Pharmaceutical Medicine. He has experience in all phases of drug development in
many different therapeutic fields. He joined Anthra in 1996. Dr. Wood has an
M.B., B. Ch. from the University of Wales, and has received several medical and
pharmaceutical graduate degrees.
CONSULTANT
Joseph V. Gulfo, M.D. has spent the past nine years in clinical drug
development. As Assistant Medical Director at Oxford Research International from
January 1989 to November 1990, he had responsibility for clinical development
programs for both prescription and over-the-counter drugs. He directed the
successful NDA filing for Actinex (a topical antineoplastic), a successful
Orphan Drug filing, and two prescription to over-the-counter switches. He joined
Cytogen Corp. in 1990 as Director of Clinical Investigations, where his primary
responsibility was management and coordination of all phases of clinical
development of novel in vivo diagnostic and immunotherapeutic products for
cancer detection and treatment. Dr. Gulfo was responsible for the development of
ProstaScint(R), an approved in vivo immunodiagnostic agent for patients with
prostate cancer. In mid-1994, Dr. Gulfo was appointed Vice President -- Clinical
Trials at Anthra. From April 1997 until September 1998, he was Executive Vice
President and Chief Operating Officer of Anthra, and from December 1997 until
September 1998, he served as a Director of the Company. Dr. Gulfo has agreed to
provide certain consulting services to the Company during a transition period,
including assisting the Company in attempting to secure final NDA
approval/labeling and approved marketing materials for a launch of
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Valstar(TM) and identifying a suitable replacement and providing transition
training. Dr. Gulfo received his B.S. and M.B.A. from Seton Hall University and
M.D. from the University of Medicine & Dentistry -- New Jersey.
RESEARCH SUPPORT
Because Anthra focuses on clinical and commercial development of drug
candidates discovered and tested by third parties, the Company does not have to
invest heavily in the infrastructure required to support pre-clinical research
and development and manufacturing. Thus, the Company's non-clinical research and
development activities concentrate on supporting regulatory submissions with
data on toxicology, manufacturing, formulation, and stability testing. These
studies are contracted to well established specialist research organizations and
managed by Dr. Thunberg.
Anthra has a long-term relationship with the University of Tennessee
whereby Anthra provides a monthly contribution of $10,100 to support research in
the laboratory of Dr. Mervyn Israel. This support is in the form of an
unrestricted gift from the Company. See "Certain Relationships and Related
Transactions."
SCIENTIFIC ADVISORY BOARD
Anthra's Scientific Advisory Board is comprised of internationally
recognized clinical researchers in urology and oncology. This Board advises
Anthra's management on strategic issues related to the Company's clinical
development programs.
Robert R. Bahnson, M.D. is Louis Levy Professor of Cancer and Director,
Division of Urology at Ohio State University. Prior to moving to Ohio State in
1996, he spent more than 15 years in clinical research in urology and urologic
oncology at the University of Pittsburgh, Washington University (St. Louis,
Missouri) and Northwestern University. He is a member of the Urologic Advisory
Council of the American College of Surgeons and has previously served as a
member of the Genitourinary Steering Committee of ECOG, the Editorial Committee
of the Journal of Urology, and the Research Committee of the American Urological
Association. He was honored with a listing in the 1996-1997 edition of Best
Doctors in America: Northeast Region. Dr. Bahnson has a B.A. from Carleton
College, a B.S. from the University of South Dakota, and an M.D. from Tufts
University.
H. Barton Grossman, M.D. holds the W.A. "Tex" and Deborah Moncrief Chair of
Urology at the University of Texas M.D. Anderson Cancer Center. He previously
had academic and clinical appointments at the University of Michigan Medical
Center, Ann Arbor, and affiliated institutions. He is Chairman of the NIH
Bladder Center Marker Network, the Organ Site Chairman for Local Bladder Cancer
of SWOG, and a member of the American Joint Committee on Cancer's Task Force on
Genitourinary Cancers, and has devoted more than 20 years to research and
treatment of genitourinary cancers. Dr. Grossman has a B.A. from LaSalle College
and an M.D. from Temple University.
Brian Leyland-Jones, M.D. is Professor of Oncology & Medicine and occupies
the Minda de Gunzburg Chair of Oncology at McGill University. Prior to moving to
McGill University in 1990, he was, among other things, Chief of the
Developmental Chemotherapy Section in the Investigational Drug Branch at the
National Cancer Institute and held staff appointments at Cornell University
Medical College, Memorial Sloan-Kettering Cancer Center and the New York
Hospital in Pharmacology, Clinical Pharmacology, Internal Medicine and Oncology.
Dr. Leyland-Jones holds degrees from the University of London and St. Mary's
Hospital Medical School of the University of London.
Mark J. Ratain, M.D. is a hematologist/oncologist and Professor of Medicine
at the University of Chicago. He is also Chairman of the University's Committee
on Clinical Pharmacology, as well as Co-Director of its Clinical and
Experimental Therapeutics Program in the Cancer Research Center. He is the
immediate past Secretary-Treasurer of the American Society of Clinical Oncology
and also holds several leadership positions in the American Society for Clinical
Pharmacology and Therapeutics. Dr. Ratain has an A.B. from Harvard and an M.D.
from Yale University.
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\SUMMARY OF EXECUTIVE COMPENSATION
The table below sets forth information concerning the annual and long-term
compensation for services rendered in all capacities to the Company during the
twelve months ended June 30, 1998 for: (i) the Chief Executive Officer of the
Company and (ii) the three other most highly paid executive officers of the
Company (collectively, the "Named Executive Officers"):
SUMMARY COMPENSATION TABLE
LONG-TERM
COMPENSATION
AWARDS
------------
ANNUAL COMPENSATION SECURITIES
-------------------- UNDERLYING
NAME AND PRINCIPAL POSITION SALARY(1) BONUSES OPTIONS
--------------------------- --------- ------- ------------
Michael C. Walker
Chief Executive Officer and President..................... $258,332 $0 50,000
Joseph V. Gulfo(2)
Former Executive Vice President and Chief Operating
Officer................................................... $210,192 $0 150,000
Allen L. Thunberg
Vice President -- Pre-Clinical Development................ $135,528 $0 11,500
Denise Webber
Vice President -- Clinical and Regulatory Operations...... $113,075 $0 31,500
- ---------------
(1) The cost of certain perquisites and other personal benefits are not included
because they did not exceed the lesser of either $50,000 or 10% of the total
of the annual salary and bonus reported for the Named Executive Officer.
(2) In September 1998 Dr. Gulfo resigned as a Director and executive officer of
the Company.
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OPTION GRANTS IN THE TWELVE MONTHS ENDED JUNE 30, 1998
The following table sets forth information regarding stock options granted
pursuant to Anthra's 1990 Stock Plan, as amended (the "1990 Plan"), during the
twelve months ended June 30, 1998 to each of the Named Executive Officers. The
Company has never granted any stock appreciation rights.
OPTION GRANTS IN LAST FISCAL YEAR
INDIVIDUAL GRANTS
----------------------------------------------------------------------
PERCENT OF POTENTIAL REALIZABLE
TOTAL OPTIONS VALUE AT ASSUMED
NUMBER OF GRANTED TO ANNUAL RATES OF STOCK
SECURITIES EMPLOYEES IN EXERCISE OR MARKET PRICE PRICE APPRECIATION FOR
UNDERLYING FISCAL YEAR BASE PER SHARE ON OPTION TERM(3)
OPTIONS ENDED JUNE 30, PRICE PER THE DATE OF EXPIRATION -----------------------
NAME GRANTED(1) 1998(%)(2) SHARE GRANT DATE 5% 10%
---- ---------- -------------- ----------- ------------- ---------- ---------- ----------
Michael C. Walker.... 50,000 7.05% $1.00 $3.00 10/16/07 $194,334 $339,061
Joseph V. Gulfo(4)... 75,000 $1.00 $3.00 10/16/07 $291,501 $508,592
75,000 (5) $8.00 5/15/08 -- --
------- -------- --------
150,000 21.14% $291,501 $508,592
Allen L. Thunberg.... 7,500 $3.00 $5.00 12/11/07 $ 38,584 $ 74,765
4,000 $8.00 $8.00 4/23/08 $ 20,125 $ 51,000
------- -------- --------
11,500 1.62% $ 58,709 $125,765
Denise Webber........ 10,000 $3.00 $5.00 12/11/07 $ 51,445 $ 99,687
21,500 $8.00 $8.00 4/23/08 $108,170 $274,124
------- -------- --------
31,500 4.44% $159,615 $373,811
- ---------------
(1) Such options were granted pursuant to and in accordance with the 1990 Plan.
See "1990 Stock Plan."
(2) Based on an aggregate of 709,500 options granted to employees in the twelve
months ended June 30, 1998, including options granted to Named Executive
Officers.
(3) Based on the grant date fair market value per share as stated, gains are
reported net of the option exercise price, but before taxes associated with
exercise. These amounts represent certain assumed rates of appreciation.
Actual gains, if any, on stock option exercises are dependent on the future
performance of the Common Stock and overall stock market conditions, as well
as the option holder's continued employment with the Company throughout the
vesting period. The amounts reflected in this table will not necessarily be
achieved.
(4) In September 1998 Dr. Gulfo resigned as a Director and executive officer of
the Company.
(5) Exercise price will be equal to the fair market value on the date of
occurrence of certain future events.
JUNE 30, 1998 -- FISCAL YEAR END OPTION VALUES
The following table sets forth information concerning the value of
unexercised in-the-money options held by the Named Executive Officers as of June
30, 1998. No Named Executive Officer exercised any options in the twelve months
ended June 30, 1998.
AGGREGATE OPTION EXERCISES IN LAST FISCAL YEAR
AND FISCAL YEAR-END OPTION VALUES
-----------------------------------------------------------
NUMBER OF SECURITIES VALUE OF UNEXERCISED
UNDERLYING UNEXERCISED IN-THE-MONEY
OPTIONS AT OPTIONS AT
FISCAL YEAR END FISCAL YEAR END(1)
---------------------------- ----------------------------
NAME EXERCISABLE UNEXERCISABLE EXERCISABLE UNEXERCISABLE
---- ----------- ------------- ----------- -------------
Michael C. Walker............................ 163,000 100,000 $790,550 $415,000
Joseph V. Gulfo(2)........................... 38,000 162,000 $175,280 $678,420
Allen L. Thunberg............................ 14,000 28,500 $ 60,200 $105,300
Denise Webber................................ 5,000 16,000 $ 23,120 $ 47,240
- ---------------
(1) Assumes a market price for the Common Stock at June 30, 1998 of $5.00 per
share.
(2) In September 1998 Dr. Gulfo resigned as a Director and executive officer of
the Company.
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EMPLOYMENT AGREEMENTS
In December 1990, the Company entered into an employment agreement with
Michael C. Walker pursuant to which Mr. Walker serves as the Company's President
and Chief Executive Officer. Such employment agreement, as currently amended,
provides Mr. Walker with a base salary of $20,833 per month, provided for
certain grants of options to purchase shares of the Company's Common Stock to
Mr. Walker in fiscal year 1990, and required that Mr. Walker execute and deliver
a separate confidentiality and noncompetition agreement. Mr. Walker's employment
agreement may be terminated by either party with 60 days prior written notice.
The Company does not have written employment agreements with any of its
employees other than Mr. Walker.
The Company has an agreement with each of Mr. Walker and Allen L. Thunberg,
its Vice President -- Pre-Clinical Development, pursuant to which, in the event
of a sale of 80% or more of the outstanding capital stock of the Company in a
single or integrated transaction or the sale of the Company through a merger or
consolidation where the Company is not the surviving corporation, in each case
where the Company's stockholders prior to the transaction own less than 50% of
the outstanding capital stock of the Company after the transaction, Messrs.
Walker and Thunberg will each receive a payment equal to 12 months of his base
salary as of the date of the transaction so long as such individual agrees to
continue working for the new successor entity in a specified capacity for three
months following the consummation of the transaction, provided, however, that
such transaction must occur within two years of the date of such agreement and
such individual must be employed by the Company.
The Company has a consulting agreement with Dr. Mervyn Israel, the
Company's Chairman of the Board and Secretary, dated as of December 5, 1990,
pursuant to which Dr. Israel provides scientific consulting services to the
Company in consideration of $3,750 per month. Dr. Israel's consulting agreement
does not contain a specified term and may be terminated by either party with 60
days prior written notice.
Anthra does routinely enter into written agreements with consultants
providing clinical, medical writing, regulatory consulting or business
development services, none of which is material to the Company's business. The
Company has executed non-disclosure agreements with each of its current
employees.
1990 STOCK PLAN
By action of the Board of Directors of the Company on December 3, 1990, the
Company adopted the 1990 Plan, which was approved by vote of the stockholders at
the annual meeting of stockholders held on December 3, 1990. The 1990 Plan
authorizes the Company to grant to eligible employees, Directors and consultants
of the Company, as determined by the Board of Directors, options to purchase
shares of the Company's Common Stock. The 1990 Plan also permits the Company to
grant to such individuals certain awards of Common Stock, and certain rights to
make direct purchases of Common Stock.
As of June 30, 1998, the 1990 Plan authorized the Company to issue options
to purchase up to 1,700,000 shares of the Company's Common Stock, and the
Company had outstanding options for a total of 1,535,487 shares of Common Stock,
of which none have been exercised and 30,200 were cancelled since June 30, 1998.
The 1990 Plan provides for options that qualify as incentive stock options
("ISOs") under Section 422 of the Internal Revenue Code of 1986, as amended, as
well as non-statutory (or non-qualified) stock options. The exercise price for
any non-qualified options granted pursuant to the 1990 Plan may not be less than
the lesser of the book value per share of the Common Stock as of the end of the
fiscal year immediately preceding the date of the grant, or 50% of the fair
market value of the Common Stock on the date of the grant. The exercise price
for any ISOs granted pursuant to the 1990 Plan may not be less than 100% of the
fair market value of the Common Stock on the date of grant, and, in the case of
an ISO stock option to be granted to an employee owning more than 10% of all
voting power of the Company or any affiliated company, the exercise price may
not be less than 110% of the fair market value on the date of grant. The 1990
Plan provides that, in the event of a change in control of the Company pursuant
to which either all or substantially all of the Company's assets are sold, 80%
or more of the Company's outstanding capital stock is sold by tender offer,
exchange offer or otherwise, the Company is sold through a consolidation or
merger where the Company is not the surviving
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corporation, or the acquisition is a result of a reverse triangular merger and
the previous stockholders own an aggregate of less than 50% of the surviving
corporation after such transaction, then optionees are entitled after any such
event to exercise all outstanding but unvested options, as well as all
outstanding vested options issued to them. In the event of a recapitalization or
reorganization of the Company (other than as described above), pursuant to which
securities of the Company or of another corporation are issued with respect to
the Company's outstanding Common Stock, an optionee, upon exercising an option,
shall be entitled to receive for the purchase price paid, upon such exercise,
the securities he would have received if he had exercised his option prior to
such recapitalization or reorganization.
Subject to certain restrictions and limitations, options granted under the
1990 Plan typically have a term of ten years from the date of grant. ISOs
exercisable upon the date of death or disability of any ISO optionee remain
exercisable until the earlier of the specified expiration date or the date one
year from the date of the optionee's death or disability. If an ISO optionee
ceases to be employed by the Company for any reason other than for death or
disability, no further installments of ISOs shall vest, and ISOs which are
exercisable shall terminate, subject to certain restrictions and limitations,
one year from the date of termination, but in no event later than on their
specified expiration dates. Options granted under the 1990 Plan may not be
transferred or assigned, other than by will or by the laws of descent and
distribution.
The 1990 Plan shall expire on December 2, 2000, except as to options
outstanding as of such date. The Board of Directors of the Company may terminate
or amend the 1990 Plan at any time; provided, however, that certain amendments
shall require stockholder approval, and in no event may the Board of Directors
impair the rights of a grantee under the 1990 Plan with respect to any of rights
previously granted under the 1990 Plan.
The Company has agreed with the Underwriter that it will not file any
registration statement to register any of the securities granted or issued under
the Company's 1990 Plan during the 13 months following the closing date of the
Offering without the Underwriter's prior written consent.
401(k) RETIREMENT SAVINGS PLAN
During June 1998, the Company established a duly adopted 401(k) retirement
savings plan, pursuant to which eligible employees may direct a percentage of
their compensation, as restricted by statutory limitations, to be withheld by
the Company and contributed to their account. All 401(k) plan contributions are
placed in a trust fund which is invested by the 401(k) plan's trustee, and the
401(k) plan permits participants to direct the investment of their account
balances among mutual or investment funds which are available under the plan. It
is anticipated that the Company may at future dates, at management's discretion,
make matching contributions under the 401(k) plan. Amounts contributed to
participant accounts under the 401(k) plan and any earnings or interest accrued
on the participant accounts are generally not subject to Federal income tax
until distributed to the participant and may not be withdrawn until death,
retirement, or termination of employment.
COMMITTEES OF THE BOARD OF DIRECTORS
In December 1990, the Board of Directors designated a Compensation
Committee, to consist of three members. Paul G. Gooding, a nonemployee Director,
has indicated his willingness to serve on the Compensation Committee if
appointed. The Board of Directors intends to reduce the size of the Compensation
Committee to two members and appoint Dr. Gooding as a member along with another
nonemployee Director, at its next regularly scheduled meeting. The Compensation
Committee reviews executive salaries, administers any bonuses and incentive
compensation, and makes recommendations to the Board of Directors with respect
to stock options of the Company issuable to management employees and Directors
of the Company. In addition, the Compensation Committee consults with management
of the Company regarding compensation policies and practices of the Company. In
April 1998, the Board of Directors designated an Audit Committee to consist of
three members. The Board of Directors has appointed William Engbers, a
nonemployee Director, as a member of the Audit Committee, and intends to appoint
two additional nonemployee Directors to the Audit Committee at its next
regularly scheduled meeting. The Audit
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66
Committee reviews the professional services provided by the Company's
independent auditors, the annual financial statements of the Company and the
Company's internal financial controls. There have been no meetings of the Audit
Committee.
DIRECTOR COMPENSATION
Fees. None of the Company's Directors receive cash compensation for
attendance at meetings of the Board of Directors or at meetings of committees of
the Board of Directors of which they are members. All Directors receive
reimbursement for reasonable travel expenses incurred in connection with
attendance at each Board of Directors and committee meeting.
Stock Options. To attract and retain independent Directors for the Company
and to compensate Directors who are included as management of the Company, the
Company has issued, and intends to continue to issue, to its Directors, options
to purchase the Company's Common Stock pursuant to the 1990 Plan, in amounts
determined at the discretion of the Board of Directors and exercisable at a
price equal to the fair market value of the Common Stock on the date of grant.
These options typically vest over a three year period. Independent Directors are
typically granted stock options upon their initial appointment, and independent
Directors and stockholder representative Directors may be granted stock options
during their term of service as an incentive for continued service. Employee
Directors are not granted stock options for their services as Directors.
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PRINCIPAL STOCKHOLDERS
The following table sets forth certain information regarding beneficial
ownership of the Company's Common Stock as of September 24, 1998, and as
adjusted to reflect the sale by the Company of the securities offered hereby
(assuming no exercise of the Underwriter's over-allotment option and no exercise
of the Warrants, the Underwriter's Warrant or the Warrants underlying the Units
underlying the Underwriter's Warrant), by: (i) each Director of the Company;
(ii) each Named Executive Officer of the Company; (iii) all Directors and
executive officers of the Company as a group; and (iv) each beneficial owner of
more than 5% of the outstanding Common Stock. To the knowledge of the Company,
all persons listed below have sole voting and investment power with respect to
their shares of Common Stock, except to the extent set forth in the footnotes to
the table below or that authority is shared by their respective spouses under
applicable law.
PERCENTAGE OWNED(2)
-------------------------
SHARES OF COMMON STOCK AS OF
NAME, TITLE AND ADDRESS OF BENEFICIALLY OWNED AS OF SEPTEMBER 24, AFTER
BENEFICIAL OWNER(1) SEPTEMBER 24, 1998(2) 1998 OFFERING
-------------------------- ------------------------ ------------- --------
Mervyn Israel(3).................................... 493,834 9.83% 7.03%
Chairman of the Board and Secretary
c/o University of Tennessee
Department of Pharmacology
College of Medicine
874 Union Avenue,
Memphis, TN 38163
Michael C. Walker(4)................................ 560,500 11.15% 7.98%
President, Chief Executive Officer and Director
Paul G. Gooding(5).................................. 30,834 0.63% 0.45%
Director
c/o Habitat
Hope Town, Abaco, Bahamas
William Engbers(6).................................. 3,334 0.07% 0.05%
Director
c/o Allstate Insurance Company
3075 Sanders Road, Suite G5D
Northbrook, IL 60062-7127
Allen L. Thunberg(7)................................ 14,000 0.29% 0.20%
Vice President -- Pre-Clinical Development
Allstate Insurance Company(8)....................... 1,140,392 23.49% 16.64%
3075 Sanders Road
Suite G5D
Northbrook, IL 60062-7127
Aperture Associates, L.P............................ 420,588 8.66% 6.14%
c/o Horsley Bridge Partners, Inc.
505 Montgomery Street, 21st Floor
San Francisco, CA 94111
Sevin Rosen Fund III, L.P........................... 919,803 18.94% 13.42%
Two Galleria Tower
13455 Noel Road, Suite 1670
Dallas, TX 75240
Advanced Technology Ventures III, L.P............... 744,805 15.34% 10.86%
281 Winter Street, Suite 350
Waltham, MA 02154
Schering AG, Germany(9)............................. 471,276 9.71% 6.87%
13342 Berlin
Germany
Nycomed............................................. 300,000 6.18% 4.38%
Nycomed Pharma AS
P.O. Box 4220
Torshov, 0401 Oslo
Norway
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PERCENTAGE OWNED(2)
-------------------------
SHARES OF COMMON STOCK AS OF
NAME, TITLE AND ADDRESS OF BENEFICIALLY OWNED AS OF SEPTEMBER 24, AFTER
BENEFICIAL OWNER(1) SEPTEMBER 24, 1998(2) 1998 OFFERING
-------------------------- ------------------------ ------------- --------
Denise Webber(10)................................... 6,000 0.12% 0.09%
Vice President -- Clinical and Regulatory
Operations
All Directors and executive officers................ 1,112,502 21.18% 15.34%
as a group (9 persons)(11)
- ---------------
(1) Unless otherwise noted, the address of each of the persons listed is 103
Carnegie Center, Suite 102, Princeton, New Jersey 08540.
(2) A person is deemed to be the beneficial owner of securities that can be
acquired within 60 days from the date of this Prospectus through the
exercise of any option, warrant or right. Shares of Common Stock subject to
options, warrants or rights which are currently exercisable or exercisable
within 60 days are deemed outstanding for computing the ownership
percentage of the person holding such options, warrants or rights, but are
not deemed outstanding for computing the ownership percentage of any other
person. The amounts and percentages are based upon 4,855,183 shares of
Common Stock outstanding as of September 1, 1998, and 6,855,183 shares of
Common Stock outstanding as of the close of the Offering, respectively. The
Company is currently attempting to obtain agreements from all of the
holders of the Preferred Stock to convert all of their shares of Preferred
Stock into the same number of shares of Common Stock upon the closing of
the Offering. The calculation of the number of shares of Common Stock
assumes that the Company is successful in its attempt to obtain agreements
from all of the holders of the Preferred Stock to convert their shares and
reflecting the resultant conversion of the outstanding Preferred Stock upon
consummation of the Offering and the shares of Common Stock receivable upon
such conversion are included in such number.
(3) Includes 166,334 shares of Common Stock subject to options exercisable
within 60 days of the date of the Offering.
(4) Includes 173,000 shares of Common Stock subject to options exercisable
within 60 days of the date of the Offering, and excludes (i) 50,000 shares
of Common Stock subject to options, which vest on the achievement of a
certain milestone, issued on June 11, 1996, and (ii) 40,000 shares of
Common Stock subject to options, which vest over a five year period, issued
on October 16, 1997.
(5) Includes 30,834 shares of Common Stock subject to options exercisable
within 60 days of the date of the Offering.
(6) Includes 3,334 shares of Common Stock subject to options exercisable within
60 days of the date of the Offering. Excludes 1,140,392 shares of Common
Stock owned by Allstate Insurance Company and Allstate Life Insurance
Company, companies for which Mr. Engbers serves as a venture capital
manager. Mr. Engbers disclaims beneficial ownership of any shares owned by
Allstate Insurance Company and Allstate Life Insurance Company.
(7) Includes 14,000 shares of Common Stock subject to options exercisable
within 60 days of the date of the Offering. Excludes (i) 12,000 shares of
Common Stock subject to options, which vest over the next three years, a
total of 20,000 were issued on April 11, 1996 and, (ii) 5,000 shares of
Common Stock subject to options, which vest over the next two years, a
total of 10,000 were issued on June 10, 1996 and, (iii) 4,000 shares of
Common Stock subject to options, which vest over the next four years, a
total of 5,000 were issued February 12, 1997 and, (iv) 7,500 shares of
Common Stock subject to options, which vest over the next five years,
issued December 11, 1997 and, 4,000 shares of Common Stock subject to
options, which vest on the achievement of certain milestones issued April
23, 1997.
(8) Includes 456,157 shares of Common Stock owned by Allstate Life Insurance
Company, a wholly-owned subsidiary of Allstate Insurance Company.
(9) Includes 271,276 shares of Common Stock owned by Schering Berlin Venture
Corporation, an affiliate of Schering AG, Germany.
(10) Includes 6,000 shares of Common Stock subject to options exercisable within
60 days of the date of the Offering, Excludes (i) 1,000 shares of Common
Stock subject to options, which vest over the next year, a total of 5,000
were issued on February 28, 1995 (ii) 1,000 shares of Common Stock subject
to options, which vest over the next three years, a total of 2,500 shares
were issued on March 27, 1995, (iii) 2,000 shares of Common Stock subject
to options, which vest over the next four years, a total of 2,500 shares
were issued on February 28, 1997 and, (iv) 10,000 shares of Common Stock
subject to options, which vest over the next five years, issued on December
11, 1997 and, (v) 6,500 shares of Common Stock subject to options, which
vest on the achievement of certain milestones issued on April 23, 1998 and,
(vi) 15,000 shares of Common Stock subject to options, which vest over the
next five years issued on April 23, 1998.
(11) Includes 397,502 shares of Common Stock subject to options exercisable
within 60 days of the date of the Offering.
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CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
The Company had an agreement with M.C. Walker & Associates, Inc., a New
Jersey corporation ("MCW") that is owned by Michael C. Walker, the Company's
President, Chief Executive Officer and Director, to provide certain
administrative services and maintain an office for the benefit of the Company
for a monthly fee of $4,166. The Company paid to MCW pursuant to this
arrangement a total of $81,667 (including amounts related to prior years) during
the 12 months ended June 30, 1997, and a total of $65,062 for the twelve months
ended June 30, 1998, in each case in consideration for amounts owed for such
services prior to December 31, 1996. At June 30, 1998, no amounts remained
payable by the Company to MCW. There was no written agreement between MCW and
the Company in effect during 1997 or 1998 and the arrangement between MCW and
the Company no longer exists. It is anticipated that there will be no such
future arrangement between the Company and MCW.
The Company has a consulting agreement with Dr. Mervyn Israel, the
Company's Chairman of the Board and Secretary, pursuant to which the Company
pays Dr. Israel $3,750 per month for scientific consulting services. See
"Management -- Employment Agreements." During the 12 months ended June 30, 1998,
the Company paid a total of $45,000 to Dr. Israel pursuant to this agreement,
which is expected to continue to be effective in the immediate future.
The Company provides an unrestricted gift of $10,100 for research support
on a monthly basis to the University of Tennessee, the entity at which Dr.
Israel, the Company's Chairman of the Board, Secretary and Director, is
employed. During the 12 months ended June 30, 1998, the Company paid a total of
$121,200 to the University of Tennessee, and thereafter has continued, and
anticipates continuing in the future, making such unrestricted monthly gifts for
research support.
In September 1997, the Company hired Mr. Richard Onyett as its Senior Vice
President -- Corporate Development. In addition to his corporate development
responsibilities, Mr. Onyett manages the Company's U.K. operations, including
clinical development. Mr. Onyett's annual salary is L95,000 ($159,600 using a
conversion factor of 1.68 dollars for 1 British pound) and the Company has
granted Mr. Onyett certain options, none of which have vested. The Company does
not have an employment agreement with Mr. Onyett.
The Company paid in the twelve months ended June 30, 1997, the sum of
$25,000 to Starlight, a consulting firm, in respect of organizational and
administrative services regarding exhibits of the Company's products. Starlight
is owned by Ms. Canice Lindsay, the wife of Michael C. Walker, the President,
Chief Executive Officer and Director of the Company. The arrangement between
Starlight and the Company no longer exists, and it is anticipated that there
will be no such future arrangement between the Company and Starlight.
Any transactions between the Company and its affiliated entities, executive
officers, Directors, or significant stockholders require the approval of a
majority of the independent Directors of the Company and must be on terms that
must be no less favorable to the Company than the Company could obtain from non-
affiliated parties.
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DESCRIPTION OF SECURITIES
The following description of the Company's securities does not purport to
be complete and is subject in all respects to applicable Delaware law, and to
the provisions of the Company's Amended Certificate of Incorporation and Bylaws,
the Unit and Warrant Agreement between Anthra and American Stock Transfer &
Trust Company (the "Warrant Agreement"), the Underwriter's Option Agreement for
Units (with respect to the Underwriter's Warrant) between the Company and the
Underwriter (the "Underwriter's Warrant Agreement"), the Underwriting Agreement
between the Company and the Underwriter, and the Fifth Amended and Restated
Registration Rights Agreement between the Company and certain of the Company's
shareholders, copies or forms of which have been filed as exhibits to the
Registration Statement, as amended, of which this Prospectus is a part.
The authorized capital stock of the Company consists of (i) 15,000,000
shares of Common Stock; (ii) 3,789,683 shares of Preferred Stock; and (iii)
1,000,000 shares of preferred stock, $.01 par value, all of which are without
designation. Immediately prior to the completion of the Offering, 4,855,183
shares of Common Stock will be issued and outstanding (assuming no exercise of
outstanding options and including 3,789,683 shares issuable upon the conversion
of 3,789,683 outstanding shares of Preferred Stock), and no shares of Preferred
Stock will be issued and outstanding. Immediately following the completion of
the Offering, the Company plans to amend and restate the Amended Certificate of
Incorporation to (i) cancel and retire all currently authorized shares of
Preferred Stock, and (ii) integrate the Company's Certificate of Incorporation
and the amendments thereto into one document. The Company plans to solicit
shareholder approval for such action prior to the completion of the Offering.
UNITS
Each Unit offered hereby consists of one share of Common Stock and one
Warrant. The shares of Common Stock and Warrants included in the Units will not
be separately transferable, and the Warrants will not be exercisable, until the
Separation Date. It is the Company's intention that the Units and, effective as
of the Separation Date, the Common Stock and the Warrants, will be listed for
quotation on the American Stock Exchange. After the Separation Date, the shares
of Common Stock and the Warrants may only be transferred separately, and the
Units will no longer be quoted on the American Stock Exchange.
COMMON STOCK
Holders of Common Stock are entitled to one vote for each share held of
record on all matters on which stockholders are entitled to vote. Holders of
Common Stock do not have cumulative voting rights and, therefore, holders of a
majority of the shares of Common Stock voting for the election of Directors can
elect all of the Directors. In such event, the holders of the remaining shares
of Common Stock will not be able to elect any Directors.
Holders of Common Stock are entitled to receive such dividends as may be
declared from time to time by the Board of Directors out of funds legally
available therefor. The Company has not paid any cash dividends since inception
and does not anticipate paying cash dividends in the foreseeable future. In the
event of liquidation, dissolution, or winding up of the Company, the holders of
Common Stock are entitled to share ratably in any corporate assets remaining
after payment of all debts, subject to any preferential rights of any
outstanding preferred stock. See "Dividend Policy."
Holders of Common Stock have no preemptive, conversion, or redemption
rights and are not subject to further calls or assessments by the Company. All
of the outstanding shares of Common Stock are validly issued, fully paid, and
nonassessable. When issued, all of the shares of Common Stock included in the
Units and underlying the Warrants included in this Offering will be validly
issued, fully paid and nonassessable.
PREFERRED STOCK
The Amended Certificate of Incorporation authorizes 1,000,000 shares of an
undesignated preferred stock which the Board of Directors of the Company has the
authority, without further action by the Company's
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stockholders, to issue from time to time in one or more series and to fix the
number of shares, designations, voting powers, preferences, optional and other
special rights, and the restrictions or qualifications thereof. The rights,
preferences, privileges, and restrictions or qualifications, of different series
of preferred stock may differ with respect to dividend rates, amounts payable on
liquidation, voting rights, conversion rights, redemption provisions, sinking
fund provisions, and other matters. The issuance of preferred stock could: (i)
decrease the amount of earnings and assets available for distribution to holders
of Common Stock; (ii) adversely affect the rights and powers, including voting
rights, of holders of Common Stock and (iii) have the effect of delaying,
deferring, or preventing a change in control of the Company. The Company has no
present plans to issue any additional shares of preferred stock. The information
set forth in this Prospectus assumes that upon the completion of the Offering,
1,000,000 shares of the Company's Series A Convertible Preferred Stock, 680,000
shares of Series B Convertible Preferred Stock, 1,470,588 shares of Series C
Convertible Preferred Stock and 639,095 shares of Series D Convertible Preferred
Stock will be converted into 3,789,683 shares of Common Stock, and all such
outstanding shares of Preferred Stock will be cancelled and retired. The Series
A, B and C Convertible Preferred Stock automatically convert to Common Stock
upon the consummation of a firm commitment underwritten offering of Common Stock
in which the aggregate price paid for such shares by the public is at least
$10,000,000 and the price per share is at least $7.50; for the Series D
Convertible Preferred Stock, a per share price of at least $11.06 in a public
offering of at least $10,000,000 is required for automatic conversion to Common
Stock. It is a condition to the Offering that the Company obtain the agreement
of all holders of Preferred Stock to convert their shares of Preferred Stock to
Common Stock upon the consummation of the Offering.
WARRANTS
Underwriter's Warrant
In connection with the Offering, the Company has authorized the issuance of
the Underwriter's Warrant and has reserved 400,000 shares of Common Stock for
issuance upon exercise of such warrant (including the Warrants issuable upon
exercise of the Underwriter's Warrant). The Underwriter's Warrant will entitle
the holder to acquire up to 200,000 Units at an exercise price of $7.00 per Unit
(140% of the initial public offering price per Unit). The Underwriter's Warrant
will be exercisable at any time from the first anniversary of the date of this
Prospectus until the fifth anniversary of the date of this Prospectus.
The Warrants contained in the Units underlying the Underwriter's Warrant
shall have substantially the same terms as the Warrants sold to the public in
the Offering. The Company has agreed that it will, on one occasion during the
four-year period commencing one year from the date of this Prospectus, file a
registration statement with the Commission upon the request of the holders of
the Underwriter's Warrant (and the securities thereunder) representing a
majority of the shares of Common Stock issuable upon the exercise of such
Warrant at the Company's expense which registration statement shall include the
shares of the Company's Common Stock and Warrants underlying the Units
underlying the Underwriter's Warrant, and the shares of Common Stock underlying
the Warrants underlying the Units underlying the Underwriter's Warrant. The
registration statement is to remain effective during the entire exercise term of
the Underwriter's Warrant. The holder of the Underwriter's Warrant may demand
registration without exercising the Underwriter's Warrant. In addition, the
Company has also agreed, to provide to the Underwriter "piggyback" registration
rights covering the shares of Common Stock, Warrants and the shares of Common
Stock underlying such Warrants, subject to customary cut-back provisions. The
Underwriter's Warrant will be nontransferable for a period of one year, subject
to certain exceptions, and may be exercised as to all or a lesser number of
Units. The Underwriter's Warrant provides for cashless exercise and adjustment
in the number and price of Units to prevent dilution. The Warrants contained in
the Units underlying the Underwriter's Warrant shall be non-redeemable.
Class A Redeemable Common Stock Purchase Warrants
Each Warrant will entitle the holder to purchase one share of Common Stock
at a price of $6.00 per share. The Warrants will, subject to certain conditions,
be exercisable at any time after the Separation Date
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and until the fifth anniversary of the date of this Prospectus, unless earlier
redeemed. The Warrants are redeemable by the Company, in whole or in part, on or
after the date 15 months from the date of this Prospectus at $.10 per Warrant,
upon at least thirty days' prior written notice to the registered holders
thereof, provided that (i) the last sales price of the Common Stock as reported
on the American Stock Exchange has been at least $9.00 for twenty consecutive
trading days ending within ten days of the date of the notice of redemption and
(ii) there is a current registration statement covering the resale of the
underlying shares of Common Stock. If the Company gives notice of its intention
to redeem, a holder must exercise his or her Warrant before the date specified
in the redemption notice or accept the redemption price for the number of
Warrants to be redeemed.
The Warrants will be issued in registered form under the Warrant Agreement.
The shares of Common Stock underlying the Warrants, when issued upon exercise of
a Warrant and following full payment of the exercise price by the holder, will
be fully paid and nonassessable, and the Company will pay any transfer tax
incurred as a result of the issuance of Common Stock to the holder upon its
exercise.
The Warrants and the Underwriter's Warrant contain provisions that protect
the holders against dilution by adjustment of the exercise price. Such
adjustments will occur in the event, among others, that the Company makes
certain distributions to holders of its Common Stock. The Company is not
required to issue fractional shares upon the exercise of a Warrant or the Units
underlying the Underwriter's Warrant. The holder of a Warrant or the
Underwriter's Warrant will not possess any rights as a shareholder of the
Company until such holder exercises the Warrant or the Warrants underlying the
Units underlying the Underwriter's Warrant.
A Warrant may be exercised upon surrender of the Warrant certificate (the
"Warrant Certificate") on or before the Exercise Deadline (as defined in the
Warrant Agreement) of the Warrant at the offices of the Warrant Agent, with the
form of "Election To Purchase" on the reverse side of the Warrant Certificate
completed and executed as indicated, accompanied by payment of the exercise
price (by certified or bank check payable to the order of the Company) for the
number of shares with respect to which the Warrant is being exercised.
For a holder to exercise the Warrants, there must be a current registration
statement in effect with the Commission and qualification in effect under
applicable state securities laws (or applicable exemptions from state
qualifications requirements) with respect to the issuance of shares or other
securities underlying the Warrants. The Company is registering such securities
with the Commission pursuant to this Registration Statement. The Company has
agreed to use all commercially reasonable efforts to either (i) keep this
Registration Statement effective through the Effective Deadline (as defined in
the Warrant Agreement) or until such time as no Warrants are outstanding or (ii)
cause a registration statement with respect to the shares of Common Stock
underlying the Warrants to be effective from the Separation Date through the
Effective Deadline or until such time as no Warrants remain outstanding. In
addition, the Company has agreed to register or qualify the shares of Common
Stock issuable upon the exercise of the Warrants under the laws of various
states that may be required to cause the sale of such securities to be lawful.
The foregoing discussion of certain terms and provisions of the Warrants
and the Underwriter's Warrant is qualified in its entirety by reference to the
detailed provisions of the Warrant Agreement and the Underwriter's Warrant, the
form of each of which has been filed as an exhibit to the Registration Statement
of which this Prospectus is a part.
For the life of the Warrants and the Underwriter's Warrant, the holders
thereof have the opportunity to profit from a rise in the market price of the
Common Stock without assuming the risk of ownership of the shares of Common
Stock issuable upon the exercise of the Warrants, the Underwriter's Warrant and
the Warrants underlying the Units underlying the Underwriter's Warrant. The
holders of the Warrants and the Underwriter's Warrant may be expected to
exercise such securities at a time when the Company would, in all likelihood, be
able to obtain any needed capital by an offering of Common Stock on terms more
favorable than those provided for by such securities. Further, the terms on
which the Company could obtain additional capital during the life of such
securities may be adversely affected.
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REGISTRATION RIGHTS
Beginning six months from the date of this Prospectus, certain stockholders
are entitled to demand registration rights with respect to 3,839,683 shares of
Common Stock (the "Registrable Securities"). Pursuant to these rights such
stockholders may require that the Company file (i) up to two registration
statements under the Securities Act upon request of holders of at least 40% of
the Registrable Securities, subject to certain minimum size conditions and (ii)
an unlimited number of registration statements on Form S-3 at such time as the
Company is eligible to use Form S-3. In addition, if the Company proposes to
register any of its securities under the Securities Act, holders of the
Registrable Securities plus holders of an additional 715,000 shares of the
Company's Common Stock are entitled, subject to certain restrictions and
limitations, to include such securities in such registration. The Company is
required to bear substantially all registration and selling expenses (except for
underwriting discounts and selling commissions) in connection with the above
described registrations. The foregoing registration rights are transferable in
certain circumstances and may be amended or waived only with the written consent
of the Company and holders of at least two-thirds of the Registrable Securities
then outstanding. It is a condition of the Offering that the holders of the
foregoing registration rights waive their rights to include such securities in
the Offering and for a period of 13 months from the closing date of the
Offering.
The Company has also granted the holder of the Underwriter's Warrant
certain registration rights with respect to such warrant. See "Description of
Securities -- Warrants -- Underwriter's Warrant."
ANTI-TAKEOVER LAW
The Company is subject to Section 203 ("Section 203") of the Delaware
General Corporation Law ("DGCL"), which restricts certain transactions and
business combinations between a corporation and an "Interested Stockholder" (as
defined in Section 203) owning 15% or more of the corporation's outstanding
voting stock, for a period of three years from the date the stockholder becomes
an Interested Stockholder. Subject to certain exceptions, unless the transaction
is approved by the board of directors and the holders of at least two-thirds of
the outstanding voting stock of the corporation (excluding shares held by the
Interested Stockholder), Section 203 prohibits significant business transactions
such as a merger with, disposition of assets to, or receipt of disproportionate
financial benefits by the Interested Stockholder, or any other transaction that
would increase the Interested Stockholder's proportionate ownership of any class
or series of the corporation's stock. The statutory ban does not apply if, upon
consummation of the transaction in which any person becomes an Interested
Stockholder, the Interested Stockholder owns at least 85% of the outstanding
voting stock of the corporation (excluding shares held by persons who are both
directors and officers or by certain employee stock plans).
LIMITATION OF LIABILITY AND INDEMNIFICATION OF DIRECTORS AND OFFICERS
The Amended Certificate of Incorporation provides that to the fullest
extent permitted by Delaware law, a Director of the Company shall not be
personally liable to the Company or its stockholders for monetary damages for
breach of such Director's fiduciary duty, except for liability: (i) for any
breach of the Director's duty of loyalty to the Company or its stockholders;
(ii) for acts or omissions not in good faith or that involve intentional
misconduct or a knowing violation of law; (iii) in respect of certain unlawful
dividend payments or stock redemptions or repurchases; and (iv) for any
transaction from which the Director derives an improper benefit. The effect of
the provisions of the Amended Certificate of Incorporation is to eliminate the
rights of the Company and its stockholders (through stockholders' derivative
suits on behalf of the Company) to recover monetary damages against a Director
for breach of the fiduciary duty of care as a director (including breaches
resulting from negligent or grossly negligent behavior), except in the
situations described in clauses (i) through (iv) above. These provisions do not
limit or eliminate the rights of the Company or any stockholder to seek
nonmonetary relief such as an injunction or recession in the event of a breach
of a Director's duty of care. The Amended Certificate of Incorporation further
provides that the Company shall indemnify any person who is or was a Director,
officer, employee, or agent of the Company, or who is or was serving at the
request of the Company as a Director, officer, employee, or agent of another
corporation or entity, against expenses, liabilities, and losses incurred by any
such person by reason of the fact that such
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person is or was acting in such capacity. The Company has agreed to use its best
efforts to secure insurance prior to the date of this Prospectus on behalf of
the Company's officers and Directors for certain liabilities arising out of such
person's actions in such capacity. There can be no assurances given that the
Company will be able to obtain such insurance on commercially reasonable terms,
if at all.
TRANSFER AGENT AND REGISTRAR
The unit agent, warrant agent and transfer agent and registrar for the
Units, the Common Stock and the Warrants of the Company is American Stock
Transfer & Trust Company.
SHARES ELIGIBLE FOR FUTURE SALE
Prior to the Offering, there has been no public market for the Company's
securities. Sales of substantial amounts of shares of the Company's securities
in the public market following the Offering could adversely affect the market
price of the Units, the Common Stock and the Warrants, making it more difficult
for the Company to sell equity securities in the future at a time and price
which it deems appropriate.
Upon the completion of the Offering, the Company will have 6,855,183 shares
of Common Stock outstanding (7,155,183 if the Underwriter's over-allotment
option is exercised in full). Of these shares, the 2,000,000 shares included in
the Units sold in the Offering will be freely tradable without restriction or
further registration under the Securities Act. However, the shares of Common
Stock included in the Units will not be traded on the American Stock Exchange
until the Separation Date. The remaining 4,855,183 shares of Common Stock
outstanding as of the date of this Prospectus are "restricted securities" as
that term is defined by Rule 144 of the Securities Act, and were issued and sold
by the Company in reliance on exemptions from registration under the Securities
Act. These restricted shares may not be sold in the public market unless they
are registered under the Securities Act or are sold pursuant to an exemption
from registration, such as Rule 144, 144(k) or 701. Beginning 90 days after the
date of this Prospectus, approximately 4,855,183 restricted securities will
become eligible for sale in the public market pursuant to Rule 144 and Rule 701
under the Securities Act. Additional shares of Common Stock will become eligible
for resale in the public market at subsequent dates, including after the
Separation Date, including the shares of Common Stock issuable upon the exercise
of the Warrants, the Underwriter's Warrant and the Warrants issuable thereunder.
In general, under Rule 144, a person who has beneficially owned shares for
at least one year, including an "affiliate," as that term is defined in the
Securities Act, is entitled to sell within any three-month period a number of
shares that does not exceed the greater of 1% of the then outstanding shares of
Common Stock (approximately 68,552 shares after the completion of the Offering)
or the average weekly trading volume during the four calendar weeks preceding
filing of notice of such sale, subject to certain requirements concerning
availability of public information, and the manner and notice of sale.
In addition, affiliates must comply with the restrictions and requirements
of Rule 144, other than the one year holding period requirements, in order to
sell shares of Common Stock which are not restricted securities. Under Rule
144(k), a person who is not an affiliate and has not been an affiliate for at
least three months prior to the sale and who has beneficially owned restricted
shares for at least a two year holding period may resell such shares without
compliance with the foregoing requirements.
The Company has represented to the Underwriter that it will obtain from
substantially all of the Company's stockholders certain lock-up agreements,
pursuant to which such stockholders will agree that for a period commencing on
the date of this Prospectus and ending on the last day of the 13th month after
the closing date of the Offering (the "Lock-Up Period"), they will not, directly
or indirectly, without the prior written consent of the Underwriter, sell, offer
for sale, grant any option for the sale of or otherwise dispose (collectively,
"Dispose") of any shares of Common Stock or any securities exercisable for or
convertible into Common Stock or any rights to acquire Common Stock. The Company
has agreed with the Underwriter that it will not file any registration statement
to register any of the securities granted or issued under the Company's 1990
Plan during the 13 months following the closing date of the Offering without the
Underwriter's prior written consent.
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Certain holders of Common Stock and the holder of the Underwriter's Warrant
have certain demand and "piggyback" registration rights. See "Description of
Securities -- Registration Rights."
As of June 30, 1998, there were 1,535,487 shares of Common Stock issuable
upon exercise of options granted under the 1990 Plan. Under the 1990 Plan,
options may be granted with respect to up to 1,700,000 shares of Common Stock.
The Company intends to file Form S-8 registration statements covering these
shares within 90 days from the date of this Prospectus. The shares registered
under such registration statements will be available for resale in the open
market upon the exercise of vested options, subject to Rule 144 volume
limitations applicable to affiliates.
Prior to this Offering, there has been no public market for the Company's
securities and no prediction can be made as to the effect, if any, that market
sales of securities of the Company or the availability of securities of the
Company for sale will have on the market price of the Company's securities
prevailing from time to time. Nevertheless, sales of substantial numbers of
securities of the Company in the public market could adversely affect the market
price of the Units, the Common Stock and the Warrants and could impair the
Company's ability to raise capital through a sale of its equity securities.
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UNDERWRITING
Subject to the terms and conditions of the Underwriting Agreement, the form
of which is included as an exhibit to the Registration Statement (the
"Underwriting Agreement"), Janssen/Meyers Associates, L.P., as Underwriter, has
agreed to purchase from the Company, and the Company has agreed to sell to the
Underwriter on a firm commitment basis, the 2,000,000 Units offered hereby.
The Underwriting Agreement contains customary representations, warranties
and covenants of the Company, including the Company's entering into the
Underwriter's Warrant Agreement and the Consulting Agreement more fully
described below. In addition, the Underwriting Agreement provides that the
obligations of the Underwriter is subject to certain conditions precedent
specified therein. The nature of the Underwriter's obligation is such that the
Underwriter is committed to purchase and pay for all the Units offered hereby,
if any are purchased.
The Company has been advised by the Underwriter that the Underwriter
proposes to offer the Units directly to the public at the initial public
offering price set forth on the cover page of this Prospectus and to certain
securities dealers at such price less a concession not in excess of $ per
Unit. The Underwriter may allow, and such selected dealers may reallow, a
concession not in excess of $ per Unit to certain other dealers. After the
Offering, the price to the public, concession allowance and reallowance may be
changed by the Underwriter.
The Company has granted the Underwriter an overallotment option,
exercisable during the 45-day period after the date of this Prospectus, to
purchase up to an additional 300,000 Units at the initial public offering price
set forth on the cover page of this Prospectus, less the underwriting discounts
and commissions. The Underwriter may exercise this option only to cover
over-allotments, if any. To the extent that the Underwriter exercises this
option, in whole or in part, the Underwriter will have a firm commitment,
subject to certain conditions, to purchase such additional Units.
The Company has paid the Underwriter $25,000 on account of the
Underwriter's expenses in connection with this Offering to be applied to a
non-accountable expense allowance equal to 3% of the gross proceeds of the
Offering (including the proceeds from the sale of the Units subject to the
Underwriter's over-allotment option, if exercised).
The Company has agreed, pursuant to the terms of the Underwriter's Warrant
Agreement, to issue to the Underwriter, for nominal consideration, Underwriter's
Warrant to purchase up to 200,000 Units, at an exercise price per Unit equal to
$7.00 (140% of the initial public offering price per Unit). The Underwriter's
Warrant is exercisable for a period of four years commencing one year from the
date of this Prospectus and is not transferrable for a period of one year prior
to the exercise date except to the officers of the Underwriter or successors to
the Underwriter. The Warrants underlying the Units underlying the Underwriter's
Warrant shall have substantially the same terms as the Warrants underlying the
Units offered hereby, except that the Warrants underlying the Units underlying
the Underwriter's Warrant shall be non-redeemable. The Underwriter's Warrant
include net exercise provisions permitting the holder to pay the exercise price
by cancellation of a number of Units with a fair market value equal to the
exercise price of the remaining Units. The holder of the Underwriter's Warrant
will have no voting, dividend or other stockholders rights until the
Underwriter's Warrant is exercised. In addition, the Company has granted certain
rights to the holder of the Underwriter's Warrant to register the Common Stock
and Warrants (and the Common Stock thereunder) underlying the Units underlying
the Underwriter's Warrant. See "Description of Securities -- Registration
Rights."
In connection with this Offering the Company also will enter into the
Consulting Agreement pursuant to which the Company will (i) employ the
Underwriter as its investment banker and financial consultant for three years
for an aggregate fee of approximately $100,000 payable at closing; and (ii) for
a period of five years, pay the Underwriter a fee equal to five percent of the
amount up to $5 million and 2 1/2% of the excess, if any, over $5 million of the
consideration in any transaction consummated by the Company with a party
introduced to the Company by the Underwriter. The Consulting Agreement may be
terminated only by the Underwriter upon 30 days' notice, and the Company's
obligations to pay any finder's fee as set forth in the preceding sentence shall
survive such termination.
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The Underwriting Agreement provides that the Company will indemnify the
Underwriter and its controlling persons against certain liabilities under the
Securities Act, or to contribute to payments the Underwriter and its controlling
persons may be required to make in respect thereof.
The Company has represented to the Underwriter that it will obtain from
substantially all of the Company's stockholders certain lock-up agreements,
pursuant to which such stockholders will agree not to dispose of their shares
for the Lock-Up Period without the prior written consent of the Underwriter. The
Company has agreed with the Underwriter that it will not file any registration
statement to register any of the securities granted or issued under the
Company's 1990 Plan during the 13 months following the closing date of the
Offering without the Underwriter's prior written consent.
It is a condition to the Offering that the Company obtain the agreement of
all holders of Preferred Stock to convert these shares of Preferred Stock to
Common Stock upon the consummation of the Offering.
The Underwriter has advised the Company that, pursuant to Regulation M
under the Securities Act, certain persons participating in the Offering may
engage in transactions, including stabilizing bids, syndicate covering
transactions or the imposition of penalty bids, which may have the effect of
stabilizing or maintaining the market price of the securities offered hereunder
at a level above that which might otherwise prevail in the open market. A
"stabilizing bid" is a bid for or the purchase of the securities offered
hereunder on behalf of the Underwriter for the purpose of fixing or maintaining
the price of the securities offered hereunder. A "syndicate covering
transaction" is the bid for or the purchase of securities offered hereunder on
behalf of the Underwriter to reduce a short position incurred by the Underwriter
in connection with the Offering. A "penalty bid" is an arrangement permitting
the Underwriter to reclaim the selling concession otherwise accruing to the
Underwriter or syndicate member in connection with the offering if the
securities offered hereunder originally sold by the Underwriter or syndicate
member is purchased by the Underwriter in a syndicate covering transaction and
has therefore not been effectively placed by the Underwriter or syndicate
member. The Underwriter has advised the Company that such transactions may be
effected on the American Stock Exchange or otherwise and, if commenced, may be
discontinued at any time.
Prior to the Offering, there has been no public market for the Company's
securities. The initial public offering price for the Units has been determined
through negotiations between the Company and the Underwriter and was based on,
among other things, the Company's financial condition, the prospects of the
Company and its industry in general, the management of the Company and the
market prices of securities of companies engaged in business similar to those of
the Company.
Certain of the securities offered hereby may be initially offered outside
of the United States by the Underwriter. No action has been or will be taken in
any jurisdiction (except in the United States) that would permit a public
offering of such securities or the possession, circulation or distribution of
this Prospectus or any amendment or supplement hereto or any other material
relating to the Company or such securities in any jurisdiction where action for
that purpose is required. Accordingly, the securities offered hereby may not be
offered or sold, directly or indirectly, and neither this Prospectus or any
amendment or supplement hereto nor any other offering material or advertisements
in connection with such securities may be distributed or published, in or from
any country or jurisdiction except in compliance with any applicable rules and
regulations of any such country or jurisdiction.
The Underwriter has agreed that (i) it has not offered or sold and, for a
period of six months following consummation of the Offering, will not offer or
sell any of the securities offered hereby to persons in the United Kingdom,
except to a person whose ordinary activities involve them in acquiring, holding,
managing or disposing of investments (as principal or agent) for the purposes of
their businesses or otherwise in circumstances which have not resulted and will
not result in an offer to the public in the United Kingdom within the meaning of
the Public Offers of Securities Regulations 1995; (ii) it has complied and will
comply with all applicable provisions of the Financial Services Act 1986 with
respect to anything done by it in relation to the securities offered hereby in,
from or otherwise involving the United Kingdom; and (iii) it has only issued or
passed on and will only issue or pass on to any person in the United Kingdom any
document received by it in connection with the issuance of such securities if
that person is of a kind described in Article 11(3) of the Financial Services
Act 1986 (Investment Advertisements)(Exemptions) Order 1996, as amended, or is a
person to whom such document may otherwise lawfully be issued or passed on.
75
78
The foregoing contains a summary of the principal terms of the agreements
described above and does not purport to be complete. Reference is made to a copy
of each such agreement which are filed as exhibits to the Registration
Statement. See "Additional Information."
The Company intends to apply for listing of the Units, the Common Stock and
the Warrants on the American Stock Exchange under the proposed symbols of "APU,"
"APX" and "APW."
LEGAL MATTERS
The validity of the securities offered hereby is being passed upon for the
Company by Morrison & Foerster LLP, New York, New York. Certain legal matters
will be passed upon for the Underwriter by Goldstein & DiGioia LLP, New York,
New York.
EXPERTS
The consolidated financial statements of the Company as of June 30, 1997
and 1998, and for each of the years in the three-year period ended June 30, 1998
have been included herein and in the Registration Statement in reliance upon the
report of KPMG Peat Marwick LLP, independent certified public accountants,
appearing elsewhere herein, and upon the authority of said firm as experts in
accounting and auditing. The report of KPMG Peat Marwick LLP covering the June
30, 1998 consolidated financial statements contains an explanatory paragraph
that states that the Company's recurring losses from operations, net capital
deficiency and insufficient working capital raise substantial doubt about the
entity's ability to continue as a going concern. The consolidated financial
statements do not include any adjustments that might result from the outcome of
that uncertainty.
ADDITIONAL INFORMATION
The Company has filed with the Commission a Registration Statement on Form
S-1 under the Securities Act with respect to the Common Stock, the Warrants and
the Units offered hereby. This Prospectus constitutes a part of the Registration
Statement and does not contain all of the information set forth therein and in
the exhibits thereto, certain portions of which have been omitted as permitted
by the rules and regulations of the Commission. For further information with
respect to the Company and the Common Stock, the Warrants and the Units offered
hereby, reference is hereby made to such Registration Statement and exhibits.
Statements contained in this Prospectus as to the contents of any document are
not necessarily complete and in each instance are qualified in their entirety by
reference to the copy of the appropriate document filed with the Commission. For
further information with respect to the Company and the Common Stock, the
Warrants and the Units, reference is hereby made to such exhibits and schedules
thereto, which may be inspected and copied at the principal office of the
Commission, 450 Fifth Street, N.W., Washington, D.C. 20549, and at the regional
offices of the Commission located at Seven World Trade Center, Suite 1300, New
York, New York 10048 and Citicorp Center, 500 West Madison Street, Suite 1400,
Chicago, Illinois 60661, and copies of all or any part thereof may be obtained
at prescribed rates from the Commission's Public Reference Section at such
addresses. Also, the Commission maintains a World Wide site on the Internet at
http://www.sec.gov that contains reports, proxy and information statements and
other information regarding registrants that file electronically with the
Commission. Upon approval of the Units, the Common Stock and the Warrants for
listing on the American Stock Exchange, such reports, proxy and information
statements and other information also can be inspected at the principal office
of the American Stock Exchange, 86 Trinity Place, New York, New York 10006.
76
79
ANTHRA PHARMACEUTICALS, INC.
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
PAGE
----
Independent Auditors' Report................................ F-2
Consolidated Balance Sheets as of June 30, 1997 and 1998.... F-3
Consolidated Statements of Operations for the years ended
June 30, 1996, 1997 and 1998 and for the period from June
25, 1985 (inception) to June 30, 1998 (unaudited)......... F-4
Consolidated Statements of Stockholders' Equity (Deficit)
for the period from June 25, 1985 (inception) to June 30,
1998 (the period from June 25, 1985 (inception) to June
30, 1994 is unaudited).................................... F-5
Consolidated Statements of Cash Flows for the years ended
June 30, 1996, 1997 and 1998 and for the period from June
25, 1985 (inception) to June 30, 1998 (unaudited)......... F-6
Notes to Consolidated Financial Statements.................. F-7
F-1
80
INDEPENDENT AUDITORS' REPORT
The Board of Directors and Stockholders
Anthra Pharmaceuticals, Inc.:
We have audited the accompanying consolidated balance sheets of Anthra
Pharmaceuticals, Inc. and subsidiary (A Development Stage Enterprise) as of June
30, 1997 and 1998, and the related consolidated statements of operations,
stockholders' equity (deficit) and cash flows for each of the years in the
three-year period ended June 30, 1998. These consolidated financial statements
are the responsibility of the Company's management. Our responsibility is to
express an opinion on these consolidated financial statements based on our
audits.
We conducted our audits in accordance with generally accepted auditing
standards. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting
the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by
management, as well as evaluating the overall financial statement presentation.
We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above
present fairly, in all material respects, the financial position of Anthra
Pharmaceuticals, Inc. and subsidiary (A Development Stage Enterprise) as of June
30, 1997 and 1998, and the results of their operations and their cash flows for
each of the years in the three-year period ended June 30, 1998, in conformity
with generally accepted accounting principles.
The accompanying consolidated financial statements have been prepared
assuming that the Company will continue as a going concern. As discussed in note
1 to the consolidated financial statements, the Company has suffered recurring
losses from operations, has a net capital deficiency and has insufficient
working capital to fund its current operating requirements. These factors raise
substantial doubt about its ability to continue as a going concern. Management's
plans in regard to these matters are also described in note 1. The consolidated
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
KPMG Peat Marwick LLP
Princeton, New Jersey
August 12, 1998
F-2
81
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Balance Sheets
June 30, 1997 and 1998
PRO FORMA
JUNE 30, JUNE 30,
-------------------------- 1998
1997 1998 (NOTE 2)
------------ ----------- -----------
(UNAUDITED)
ASSETS
Current assets:
Cash and cash equivalents................................. $ 795,428 2,911,953 2,911,953
Prepaid expenses.......................................... 38,105 48,640 48,640
------------ ----------- -----------
Total current assets............................... 833,533 2,960,593 2,960,593
Equipment, net (note 3)..................................... 75,957 91,930 91,930
Deferred offering costs..................................... -- 881,780 881,780
Restricted investment (note 8).............................. -- 150,000 150,000
Other assets................................................ 5,548 15,278 15,278
------------ ----------- -----------
Total assets....................................... $ 915,038 4,099,581 4,099,581
============ =========== ===========
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable.......................................... $ 995,773 1,111,205 1,111,205
Accrued expenses (note 4)................................. 370,534 1,214,813 1,214,813
Due to related parties, net (note 6)...................... 65,062 -- --
------------ ----------- -----------
Total current liabilities and total liabilities.... 1,431,369 2,326,018 2,326,018
Contingent stock obligation (note 5)........................ -- 8,000,000 8,000,000
------------ ----------- -----------
Mandatorily redeemable convertible preferred stock (at
redemption and liquidation value which includes accreted
dividends of $2,769,998 and $3,423,057 at June 30, 1997
and 1998, respectively) (note 9); (converts into 3,150,588
pro forma common shares at June 30, 1998 upon consummation
of the offering contemplated herein):
Series A, $0.01 par value; 1,000,000 shares authorized,
issued and outstanding................................ 2,289,960 2,409,961 --
Series B, $0.01 par value; 680,000 shares authorized,
issued and outstanding................................ 2,323,288 2,459,281 --
Series C, $0.01 par value; 1,470,588 shares authorized,
issued and outstanding................................ 6,356,749 6,753,814 --
------------ ----------- -----------
10,969,997 11,623,056 --
------------ ----------- -----------
Stockholders' deficit (note 10):
Preferred stock (no designation), $0.01 par value; 1,000,000
shares authorized, none issued and outstanding............ -- -- --
Series D convertible preferred stock, $0.01 par value;
471,276 shares authorized, 339,095 shares issued and
outstanding at June 30, 1997; and 639,095 shares
authorized, issued and outstanding at June 30, 1998
(aggregate liquidation value of $7,067,624 at June 30,
1998) (converts into 639,095 pro forma common shares at
June 30, 1998 upon consummation of the offering
contemplated herein).................................... 3,391 6,391 --
Common stock, $0.01 par value; 6,000,000 shares and
15,000,000 shares authorized at June 30, 1997 and 1998,
respectively; 1,065,500 shares issued and outstanding at
June 30, 1997 and 1998, respectively; (4,855,183 pro
forma shares at June 30, 1998 upon conversion).......... 10,655 10,655 48,552
Additional paid-in capital................................ 3,368,707 8,674,378 20,265,928
Deferred compensation..................................... -- (924,821) (924,821)
Deficit accumulated during the development stage.......... (14,869,081) (25,616,096) (25,616,096)
------------ ----------- -----------
Total stockholders' deficit........................ (11,486,328) (17,849,493) (6,226,437)
Commitments and contingencies (notes 6 and 8)
------------ ----------- -----------
Total liabilities and stockholders' deficit........ $ 915,038 4,099,581 4,099,581
============ =========== ===========
See accompanying notes to consolidated financial statements.
F-3
82
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Operations
For the years ended June 30, 1996, 1997 and 1998 and for
the period from June 25, 1985 (inception) to June 30, 1998 (unaudited)
FOR THE
PERIOD FROM
JUNE 25, 1985
YEARS ENDED JUNE 30, (INCEPTION) TO
-------------------------------------- JUNE 30,
1996 1997 1998 1998
----------- ---------- ----------- --------------
(UNAUDITED)
Revenue:
Research and license revenues (note 5).................... $ 2,170,518 399,875 -- 2,570,393
Other revenue (note 5).................................... -- 1,288,240 -- 1,288,240
----------- ---------- ----------- -----------
2,170,518 1,688,115 -- 3,858,633
----------- ---------- ----------- -----------
Operating expenses:
Research and development (note 5)......................... 3,648,529 6,610,188 9,212,363 26,823,389
General and administrative (note 6)....................... 523,209 681,543 1,893,915 3,505,276
----------- ---------- ----------- -----------
Total operating expenses............................ 4,171,738 7,291,731 11,106,278 30,328,665
Other income (expense):
Interest income........................................... 111,519 138,905 359,263 888,944
Interest expense.......................................... -- -- -- (35,008)
----------- ---------- ----------- -----------
111,519 138,905 359,263 853,936
----------- ---------- ----------- -----------
Net loss............................................ (1,889,701) (5,464,711) (10,747,015) (25,616,096)
Accretion of undeclared dividends attributable to
mandatorily redeemable convertible preferred stock........ 653,059 653,059 653,059 3,423,057
----------- ---------- ----------- -----------
Net loss allocable to common stockholders........... $(2,542,760) (6,117,770) (11,400,074) (29,039,153)
=========== ========== =========== ===========
Basic and diluted net loss per share allocable to common
stockholders (note 2)..................................... $ (3.01) (5.79) (10.70)
=========== ========== ===========
Shares used in computing basic and diluted net loss per
share allocable to common stockholders (note 2)........... 843,993 1,056,733 1,065,500
=========== ========== ===========
See accompanying notes to consolidated financial statements.
F-4
83
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Stockholders' Equity (Deficit)
For the period from June 25, 1985 (inception) to June 30, 1998
(the period from June 25, 1985 (inception) to June 30, 1994 is unaudited)
SERIES D CONVERTIBLE DEFICIT
PREFERRED STOCK COMMON STOCK ACCUMULATED TOTAL
--------------------- ------------------- ADDITIONAL DURING THE STOCKHOLDERS'
NUMBER OF NUMBER OF PAID-IN DEFERRED DEVELOPMENT EQUITY
SHARES AMOUNT SHARES AMOUNT CAPITAL COMPENSATION STAGE (DEFICIT)
---------- -------- --------- ------- ---------- ------------ ----------- -------------
Balance at June 25, 1985
(inception).............. -- $ -- -- $ -- -- -- -- --
Issuance of common stock
(note 9)............... -- -- 153,000 1,530 3,060 -- -- 4,590
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1985.... -- -- 153,000 1,530 3,060 -- -- 4,590
Net loss................. -- -- -- -- -- -- (30) (30)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1986.... -- -- 153,000 1,530 3,060 -- (30) 4,560
Net loss................. -- -- -- -- -- -- (4,629) (4,629)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1987.... -- -- 153,000 1,530 3,060 -- (4,659) (69)
Net loss................. -- -- -- -- -- -- (98) (98)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1988.... -- -- 153,000 1,530 3,060 -- (4,757) (167)
Net loss................. -- -- -- -- -- -- (352) (352)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1989.... -- -- 153,000 1,530 3,060 -- (5,109) (519)
Net loss................. -- -- -- -- -- -- (57,428) (57,428)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1990.... -- -- 153,000 1,530 3,060 -- (62,537) (57,947)
Issuance of common stock
(note 10).............. -- -- 562,500 5,625 139,625 -- -- 145,250
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (69,960) -- -- (69,960)
Net loss................. -- -- -- -- -- -- (490,526) (490,526)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1991.... -- -- 715,500 7,155 72,725 -- (553,063) (473,183)
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (120,000) -- -- (120,000)
Net loss................. -- -- -- -- -- -- (554,447) (554,447)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1992.... -- -- 715,500 7,155 (47,275) -- (1,107,510) (1,147,630)
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (199,288) -- -- (199,288)
Net loss................. -- -- -- -- -- -- (1,337,017) (1,337,017)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1993.... -- -- 715,500 7,155 (246,563) -- (2,444,527) (2,683,935)
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (421,573) -- -- (421,573)
Net loss................. -- -- -- -- -- -- (2,452,640) (2,452,640)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1994.... -- -- 715,500 7,155 (668,136) -- (4,897,167) (5,558,148)
Issuance of common stock
(notes 5 and 10)....... -- -- 100,000 1,000 33,000 -- -- 34,000
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (653,059) -- -- (653,059)
Net loss................. -- -- -- -- -- -- (2,617,502) (2,617,502)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1995.... -- -- 815,500 8,155 (1,288,195) -- (7,514,669) (8,794,709)
Exercise of warrants
(note 10).............. -- -- 50,000 500 7,000 -- -- 7,500
Issuance of Series D
convertible preferred
stock (notes 5 and
9)..................... 271,276 2,713 -- -- 2,996,941 -- -- 2,999,654
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (653,059) -- -- (653,059)
Net loss................. -- -- -- -- -- -- (1,889,701) (1,889,701)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1996.... 271,276 2,713 865,500 8,655 1,062,687 -- (9,404,370) (8,330,315)
Issuance of Series D
convertible preferred
stock (note 5)......... 267,819 2,678 -- -- 2,959,079 -- -- 2,961,757
Conversion of Series D
preferred stock to
common stock........... (200,000) (2,000) 200,000 2,000 -- -- -- --
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (653,059) -- -- (653,059)
Net loss................. -- -- -- -- -- -- (5,464,711) (5,464,711)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1997.... 339,095 3,391 1,065,500 10,655 3,368,707 -- (14,869,081) (11,486,328)
Issuance of Series D
convertible preferred
stock (note 5)......... 300,000 3,000 -- -- 4,497,000 -- -- 4,500,000
Deferred compensation
resulting from grant of
options (note 10)...... -- -- -- -- 1,461,730 (1,461,730) -- --
Amortization of deferred
compensation (note
10).................... -- -- -- -- -- 536,909 -- 536,909
Accretion of undeclared
dividends on
mandatorily redeemable
convertible preferred
stock (note 9)......... -- -- -- -- (653,059) -- -- (653,059)
Net loss................. -- -- -- -- -- -- (10,747,015) (10,747,015)
-------- ------- --------- ------- ---------- ---------- ----------- -----------
Balance, June 30, 1998.... 639,095 $ 6,391 1,065,500 $10,655 8,674,378 (924,821) (25,616,096) (17,849,493)
======== ======= ========= ======= ========== ========== =========== ===========
See accompanying notes to consolidated financial statements.
F-5
84
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Consolidated Statements of Cash Flows
For the years ended June 30, 1996, 1997 and 1998 and the period
from June 25, 1985 (inception) to June 30, 1998 (unaudited)
FOR THE
PERIOD FROM
JUNE 25, 1985
YEARS ENDED JUNE 30, (INCEPTION) TO
-------------------------------------- JUNE 30,
1996 1997 1998 1998
----------- ---------- ----------- --------------
(UNAUDITED)
Cash flows from operating activities:
Net loss.................................................. $(1,889,701) (5,464,711) (10,747,015) (25,616,096)
Adjustments to reconcile net loss to net cash used in
operating activities:
Noncash compensation expense.......................... -- -- 536,909 536,909
Accrued interest converted to preferred stock......... -- -- -- 35,008
Depreciation expense.................................. 16,514 24,317 29,100 88,091
Change in assets and liabilities:
(Increase) decrease in other receivable............. (916,119) 916,119 -- --
Increase in prepaid expenses........................ (18,781) (13,130) (10,535) (48,640)
Increase in other assets............................ (2,698) -- (9,730) (15,278)
Increase in accounts payable........................ 142,635 780,371 115,432 1,111,205
Increase (decrease) in accrued expenses............. 260,585 (12,859) 844,279 1,214,813
Decrease in due to related parties, net............. (110,088) (81,667) (65,062) --
----------- ---------- ----------- -----------
Net cash used in operating activities............... (2,517,653) (3,851,560) (9,306,622) (22,693,988)
----------- ---------- ----------- -----------
Cash flows from investing activities:
Capital expenditures...................................... (50,072) (27,341) (45,073) (180,021)
Restricted investment..................................... -- -- (150,000) (150,000)
----------- ---------- ----------- -----------
Net cash used in investing activities............... (50,072) (27,341) (195,073) (330,021)
----------- ---------- ----------- -----------
Cash flows from financing activities:
Proceeds from issuance of promissory notes................ -- -- -- 1,000,000
Proceeds from issuance of common stock and exercise of
warrants................................................ 7,500 -- -- 191,340
Proceeds from issuance of preferred stock................. 2,999,654 2,961,757 4,500,000 17,626,402
Proceeds from short-term borrowings....................... -- -- -- 321,280
Repayment of short-term debt.............................. -- -- -- (321,280)
Proceeds from contingent stock obligation................. -- -- 8,000,000 8,000,000
Deferred offering costs................................... -- -- (881,780) (881,780)
----------- ---------- ----------- -----------
Net cash provided by financing activities........... 3,007,154 2,961,757 11,618,220 25,935,962
----------- ---------- ----------- -----------
Net increase (decrease) in cash and cash equivalents........ 439,429 (917,144) 2,116,525 2,911,953
Cash and cash equivalents at beginning of period............ 1,273,143 1,712,572 795,428 --
----------- ---------- ----------- -----------
Cash and cash equivalents at end of period.................. $ 1,712,572 795,428 2,911,953 2,911,953
=========== ========== =========== ===========
Supplemental schedule of noncash financing activities:
Conversion of promissory notes to preferred stock......... $ -- -- -- 1,000,000
=========== ========== =========== ===========
Deferred compensation..................................... $ -- -- 1,461,730 1,461,730
=========== ========== =========== ===========
Accretion of undeclared dividends attributable to
mandatorily redeemable convertible preferred stock...... $ 653,059 653,059 653,059 3,423,057
=========== ========== =========== ===========
Conversion of preferred stock to common stock............. $ -- 2,000 -- 2,000
=========== ========== =========== ===========
See accompanying notes to consolidated financial statements.
F-6
85
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements
June 30, 1997 and 1998
(1) ORGANIZATION AND BUSINESS ACTIVITIES
Anthra Pharmaceuticals, Inc. (Anthra or the Company) was incorporated in
Delaware on June 25, 1985. The Company is a development stage pharmaceutical
company engaged in clinical development and obtaining regulatory approval for a
portfolio of proprietary cancer drugs. The Company is currently devoting
substantially all of its efforts towards conducting pharmaceutical development,
raising capital, obtaining regulatory approval for products under development
and recruiting personnel.
The accompanying consolidated financial statements include the results of
operations of the Company and its wholly-owned subsidiary, Anthra
Pharmaceuticals Limited (since December 18, 1997). All intercompany accounts and
transactions have been eliminated in consolidation.
The Company has not yet achieved profitable operations or positive cash
flow from operations. There is no assurance that profitable operations, if ever
achieved, could be sustained on a continuing basis. In addition, development
activities and the commercialization of proprietary medical therapies for the
treatment of cancer will require significant additional financing and regulatory
approval. The Company's deficit accumulated during the development stage
aggregated $25,616,096 through June 30, 1998 and the Company expects to incur
substantial losses in future periods. Further, the Company's future operations
are dependent on the success of the Company's research and commercialization
efforts and, ultimately, upon regulatory approval and market acceptance of the
Company's products.
The accompanying consolidated financial statements have been prepared on a
going-concern basis which contemplates the continuation of operations,
realization of assets and liquidation of liabilities in the ordinary course of
business. The Company incurred net losses of $1,889,701, $5,464,711 and
$10,747,015 for the years ended June 30, 1996, 1997 and 1998, respectively, has
an accumulated deficit of $25,616,096 at June 30, 1998, has a net capital
deficiency of $17,849,493 on June 30, 1998 and has insufficient working capital
to fund its current operations. The Company plans to obtain additional financing
through an initial public offering (Offering) (see note 12), private placements
and follow-on public offerings, license payments and payments from strategic
research and development arrangements and revenue from product sales. The
Company's ability to continue as a going concern is dependent upon the financing
efforts being successful. There can be no assurance, however, that the Company
will be successful in obtaining financing at the level needed for the long-term
development and commercialization of its planned products or on terms acceptable
to the Company. The consolidated financial statements do not include any
adjustments relating to the recoverability and classifications of reported asset
amounts or the amounts or classifications of liabilities which might result from
the outcome of that uncertainty.
(2) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original
maturity of three months or less when purchased to be cash equivalents. All cash
and cash equivalents are held in United States financial institutions and money
market funds. To date, the Company has not experienced any losses on its cash
and cash equivalents. The carrying amount of cash and cash equivalents
approximates its fair value due to its short-term and liquid nature.
F-7
86
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
Equipment
Equipment, consisting primarily of computer and office equipment, is
recorded at cost. Depreciation is provided using the straight-line method over
the estimated useful lives of the assets, generally three to five years.
Expenditures for repairs and maintenance are expensed as incurred.
Research and Development
Research and product development costs are expensed as incurred.
Revenue Recognition -- Research and Development and Licensing Agreements
The Company has entered into various research and development and licensing
agreements (see note 5). Research and development revenue from
cost-reimbursement agreements is recorded as the related expenses are incurred,
up to contractual limits, and when the Company meets its performance obligations
under the respective agreements. Other contract revenue is recognized when
milestones are met and the Company's significant performance obligations have
been satisfied in accordance with the terms of the respective agreements.
Payments received that are related to future performance under such contracts
are deferred and recognized as revenue when earned. Revenue recognized is not
subject to repayment. Future losses, if any, on research and development
agreements are recognized in the period when identified by the Company.
Income Taxes
Deferred tax assets and liabilities are determined based on differences
between the financial reporting and tax bases of assets and liabilities and are
measured using the enacted tax rates and laws that will be in effect when such
differences are expected to reverse. The measurement of deferred tax assets is
reduced, if necessary, by a valuation allowance for any tax benefits which are
not expected to be realized. The effect on deferred tax assets and liabilities
of a change in tax rates is recognized in the period that such tax rate changes
are enacted.
Use of Estimates
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and
assumptions that affect the amount reported in the consolidated financial
statements and accompanying notes. Actual results could differ from those
estimates.
Stock-based Compensation
The Company accounts for its stock option issuances in accordance with the
provisions of Accounting Principles Board ("APB") Opinion No. 25, "Accounting
for Stock Issued to Employees", and related interpretations. As such, deferred
compensation is recorded to the extent that the current market value of the
underlying stock exceeds the exercise price on the date both the number of
shares and the price per share are known (measurement date). Such deferred
compensation is amortized over the respective vesting periods of such option
grants. On June 30, 1996, the Company adopted the disclosure requirements of
SFAS No. 123, "Accounting for Stock-Based Compensation", which permits entities
to continue to apply the provisions of APB Opinion No. 25 for financial
reporting purposes and provide pro forma net loss and pro forma net loss per
share disclosures for employee stock option grants made in fiscal year 1996 and
future years as if the fair-value-based method defined in SFAS No. 123 had been
applied. Transactions with non-employees, in which goods or services are the
consideration received for the issuance of equity instruments, are accounted for
under the fair-value based method defined in SFAS No. 123.
F-8
87
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
Equity Security Transactions
Since inception, the Board of Directors has established the deemed fair
value of common stock, Series A, B and C mandatorily redeemable convertible
preferred stock (Series A, B and C), Series D convertible preferred stock
(Series D) (together, Convertible Preferred Stock), stock options and warrants
based upon facts and circumstances existing at the dates such equity
transactions occurred, including the price at which equity instruments were sold
to independent third parties.
Net Loss per Share
Net loss per share is computed in accordance with SFAS No. 128, "Earnings
Per Share," by dividing the net loss allocable to common stockholders (including
accretion of undeclared dividends) by the weighted average number of shares of
common stock outstanding. As of June 30, 1998, the Company has certain options,
warrants and Convertible Preferred Stock (see notes 9 and 10), which have not
been used in the calculation of diluted net loss per share because to do so
would be anti-dilutive. As such, the numerator and the denominator used in
computing both basic and diluted net loss per share allocable to common
stockholders are equal.
Pursuant to Securities and Exchange Commission (SEC) Staff Accounting
Bulletin No. 98 and SEC staff policy, all common stock issued for nominal
consideration during the periods presented herein and through the filing of the
registration statement for the Offering are to be reflected in a manner similar
to a stock split or stock dividend for which retroactive treatment is required
in the calculation of pro-forma basic net loss per share; the Company did not
have any such issuances. Similarly, common stock and potential common stock
issued for nominal consideration during the periods presented herein and through
the filing of the registration statement for the Offering are to be reflected in
a manner similar to a stock split or stock dividend for which retroactive
treatment is required in the calculation of pro forma diluted net loss per
share, even if anti-dilutive; the Company did not have any such issuances.
Pro Forma Net Loss per Share and Pro Forma Balance Sheet (Unaudited)
The Company is currently attempting to obtain agreements from all of the
holders of Convertible Preferred Stock to convert their shares of Convertible
Preferred Stock into a like number of shares of Common Stock upon the closing of
the Offering. If the Company does not obtain such conversion agreements, the
Convertible Preferred Stock outstanding at June 30, 1998 would remain
outstanding under their current terms. The following pro forma basic and diluted
net loss per share allocable to common stockholders (excluding accretion of
undeclared dividends) and shares used in computing pro forma basic and diluted
net loss per share allocable to common stockholders have been presented assuming
the Company is successful in its attempt to obtain agreements from all of the
holders of Convertible Preferred Stock to convert their shares and reflecting
the resultant conversion into shares of common stock of the Convertible
Preferred Stock upon completion of the Offering using the if converted method
from their respective dates of issuance:
YEAR ENDED
JUNE 30,
1998
----------
Pro forma basic and diluted net loss per share allocable to
common stockholders....................................... $ (2.25)
==========
Shares used in computing pro forma basic and diluted net
loss per share allocable to common stockholders........... 4,768,060
==========
F-9
88
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
The unaudited pro forma presentation of the June 30, 1998 consolidated
balance sheet has been prepared assuming the Company is successful in its
attempt to obtain agreements from all of the holders of Convertible Preferred
Stock to convert their shares and reflecting the resultant conversion of the
3,789,683 shares of Convertible Preferred Stock into 3,789,683 shares of common
stock as of June 30, 1998.
(3) EQUIPMENT
Equipment is comprised of the following at June 30, 1997 and 1998:
JUNE 30,
--------------------
1997 1998
-------- --------
Furniture and fixtures................................. $ 19,163 28,500
Computer and equipment................................. 109,762 147,881
Laboratory equipment................................... 3,640 3,640
Leasehold improvements................................. 2,383 --
-------- --------
134,948 180,021
Less accumulated depreciation.......................... 58,991 88,091
-------- --------
$ 75,957 91,930
======== ========
(4) ACCRUED EXPENSES
Accrued expenses is comprised of the following at June 30, 1997 and 1998:
JUNE 30,
---------------------
1997 1998
-------- ---------
Contract research and development..................... $292,966 501,436
Professional and consulting fees...................... -- 22,850
Payroll and related costs............................. 62,568 104,963
Offering costs........................................ -- 552,000
Other................................................. 15,000 33,564
-------- ---------
$370,534 1,214,813
======== =========
(5) RESEARCH AND DEVELOPMENT AND LICENSE AGREEMENTS
University of Tennessee Research Corporation
In December 1990, the Company entered into a license agreement with the
University of Tennessee Research Corporation (UTRC) (which is not owned by the
University of Tennessee) covering the commercial development of its technology.
The Company is also liable to UTRC for annual royalty fees based on net sales,
if any, as defined in the agreement. Annual minimum royalties of $25,000 and
$50,000 are required for 1997 and for each year thereafter, respectively, which
is recorded as research and development expense. The Company's obligation to pay
royalties expires upon the expiration of the related patent. The license
agreement is in effect until the later to occur of the expiration of all patent
rights or seventeen years from Anthra's last acceptance of a license to an
unpatented improvement to the technology (see note 6).
F-10
89
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
Dana Farber Licensing Agreement
In November 1990, the Company entered into a licensing agreement with the
Dana Farber Cancer Institute (Dana-Farber) to acquire the unrestricted exclusive
worldwide patent and know-how license on certain technology, subject to certain
restrictions and limitations in an agreement between Dana-Farber and the U.S.
Department of Health and Human Services dated April 22, 1985. As a condition of
the agreement, the Company will grant back to Dana-Farber the right to conduct
research on a royalty-free basis on the technology. The Company is liable to
Dana-Farber for annual royalty fees based on net sales, if any, as defined in
the agreement. The Company agreed to pay Dana-Farber a minimum royalty of
$15,000 for each twelve-month period commencing on the anniversary of a New Drug
Application (NDA) approval in the United States of the technology. The
obligation to pay minimum royalties shall cease upon the termination of this
agreement. Absent any default, the agreement terminates in July 1999 or upon 90
days notice by Anthra.
Schering Development and License Agreement
In September 1995, the Company and Schering AG (Schering) entered into a
development and license agreement. Under this agreement the Company agreed to
conduct the research and development activities to prepare a certain product for
commercialization. Schering agreed to reimburse the Company for certain research
and development cost associated with the commercial development of the products
in certain territories. Under the agreement the Company granted to Schering the
exclusive, royalty bearing license in the North America and European Territories
to market, sell, and distribute the product. The Company retained co-promotion
rights in each territory, subject to certain limitations. In return, Schering
agreed to make certain lump and royalty payments to the Company based on certain
occurrences. During fiscal 1996 and 1997, the Company was entitled to
reimbursement of $2,170,518 and $199,875, respectively, which is recorded as
revenue in the accompanying statements of operations. In connection with this
agreement, Schering Berlin Venture Corporation, an affiliate of Schering,
purchased 271,276 shares of Series D for $2,999,654 (see note 9).
On July 16, 1996, the Company entered into a termination, settlement and
investment agreement under which Schering paid the Company a total of $3,500,000
for 200,000 shares of Series D and for Anthra's release of Schering from the
September 1995 agreement. The Company allocated $2,211,760 of this amount to the
sale of the Series D utilizing a value of approximately $11 per share (the per
share price being ascribed to other Series D financings). The remaining
$1,288,240 of the payment is recorded as other revenue in fiscal 1997 as a fee
for release from the September 1995 agreement. The $3,500,000 was used in fiscal
1997 for research relating to the originally licensed technology, as required by
the agreement. The Company owns all rights, title and interest in and to any
such research, data, know how, intellectual property or any other property
resulting from the research and is required to pay Schering royalties on future
product sales, if any. Schering subsequently converted the 200,000 shares of
Series D into 200,000 shares of common stock in accordance with the terms of the
preferred stock.
Prodesfarma Exclusive License Agreement
On April 17, 1997, the Company entered into an exclusive license agreement
with Prodesfarma, S.A. (Prodesfarma). Under the agreement, Prodesfarma obtained
the exclusive distribution rights to a certain product in Spain and Portugal for
an initial term of ten years from the first commercial sale. Prodesfarma made a
nonrefundable payment of $200,000, which has been recorded as revenue, to the
Company upon the signing of this agreement and is required to make further
payments aggregating up to $400,000 upon the achievement of certain milestones.
The Company is responsible for the remaining development costs and to supply the
product to Prodesfarma at prices described in the agreement. The agreement may
be terminated by
F-11
90
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
either party in certain circumstances. Concurrent with the license agreement,
Prodesfarma purchased 67,819 shares of Series D for $749,997.
Medeva Agreement
On July 15, 1997, the Company entered into a development agreement with
Medeva California Inc. (Medeva). Under this agreement, Medeva was granted an
exclusive royalty bearing license to sell, distribute and market a certain
product for certain indications, in the United States, upon regulatory approval.
In exchange, Medeva made a non-refundable payment of $8.0 million on signing the
agreement, and subject to certain restrictions and limitations, is required to
make future payments aggregating up to $18.2 million upon the achievement of
certain milestones. In September 1998, an additional $2.1 million payment
(unaudited) was made by Medeva for the Company having achieved a certain
milestone. The Company is responsible for most remaining development costs,
although Medeva will fund certain costs related to the specific indications
covered under this agreement. The Company will also supply the product to Medeva
at certain stated prices. If regulatory approval is not received for any of the
indications covered by this agreement by December 31, 2002, Medeva will have the
right to obtain, for no additional consideration, the number of common shares
equal to 20% of the then issued and outstanding voting equity securities of the
Company. Accordingly, the $8.0 million payment has been recorded as a contingent
stock obligation in the consolidated balance sheet at June 30, 1998. Upon
receipt of regulatory approval for one of the indications covered by the
agreement on or before December 31, 2002, the Company would account for that
portion of the $8 million incurred on development costs under the agreement
since July 15, 1997 as research and development revenue. Any portion of the $8
million not spent on development expenditures by the time of the regulatory
approval would be accounted for as deferred revenue and recognized as revenue as
development expenditures are made. Should the necessary regulatory approval not
be received by December 31, 2002, the $8 million would be accounted for as a
contribution to capital for the shares issued to Medeva. Any excess of the fair
value of the common stock issued to Medeva over the $8 million would represent a
benefit to Medeva and any excess of the $8 million over the fair value of the
common stock would represent a benefit to the Company. This agreement expires on
the later of loss of any orphan drug exclusivity, expiration of related patents
or twelve years. Upon Anthra's achievement of a certain future milestone under
the agreement and its receipt from Medeva of the payment related thereto, Anthra
will be obligated to make a $300,000 payment to the financial intermediary that
introduced Anthra to Medeva.
Nycomed Agreement
In October 1997, the Company entered into an exclusive license, sales and
distribution agreement with Nycomed Pharma AS (Nycomed). Under the agreement,
Nycomed obtained the exclusive distribution rights to a certain product in
certain countries for an initial term of ten years from the first European
regulatory approval, as defined. The agreement provides for future payments by
Nycomed, which are subject to certain restrictions and limitations, aggregating
up to $2 million upon achieving certain milestones. The Company will grant to
Nycomed upon receipt of certain of these milestone payments, options to purchase
up to an aggregate of 66,666 shares of either common or Series D, as determined
in accordance with the agreement, for $15 per share. The Company will also grant
to Nycomed upon the payment of a certain milestone payment, options to purchase
shares of common or Series D, as determined in accordance with the agreement,
with a fair market value, as defined, of $1 million. The Company is responsible
for the remaining development costs and to supply the product to Nycomed at
prices described in the agreement. The agreement may be terminated by either
party in certain circumstances. Concurrent with the license, sales and
distribution agreement, Nycomed purchased 300,000 shares of Series D for
$4,500,000. These shares have the same rights as the previously issued Series D.
F-12
91
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
Bonefos Term Sheet
In December 1997, the Company signed a term sheet with affiliates of
Schering to acquire the exclusive United States development and marketing rights
to a certain product for certain indications. Upon signing of the letter of
intent, the Company paid a nonrefundable amount of $250,000 to Schering in
consideration for a period of exclusivity in which to negotiate final
agreements. The amount was charged to operations in fiscal 1998. If final
development and manufacturing agreements are consummated as contemplated in the
term sheet, the Company would make additional non-refundable payments totaling
$3,500,000 by December 31, 1998. Schering would have the option to acquire from
the Company the exclusive right to market the product in the United States for
certain indications for payments aggregating up to $21,000,000, plus royalties.
In July 1998, the Company signed an Option Agreement with the affiliates of
Schering which extended the period of exclusivity, as per the term sheet signed
in December 1997 through September 30, 1998. The Company paid a nonrefundable
amount of $200,000 to Schering in consideration of this extension. This would be
credited towards the first payment which is due upon executing the definitive
development and manufacturing agreements. If executed, the Company must also
meet certain financial conditions on an on-going basis under the definitive
development agreement or the agreement may be terminated.
(6) RELATED PARTY TRANSACTIONS
The Company previously had an agreement with an executive officer of the
Company to provide certain administrative services and maintain an office for a
monthly fee of $4,166 per month. Expenses charged to the Company under this
agreement aggregated $25,000, $0 and $0 in fiscal 1996, 1997 and 1998,
respectively. This officer also had not received payment for salary and various
expenses on the Company's behalf in the early years of the Company's existence.
Payables to this executive, net of receivables from this executive of $67,925 at
June 30, 1997, were $65,062 at June 30, 1997 and $0 at June 30, 1998.
The Company, on a monthly basis, has provided an unrestricted gift for
research support to the University of Tennessee at which a founder and director
of the Company is employed. Expenses charged to the Company for such
unrestricted gift aggregated $121,200 in both fiscal 1997 and 1998.
The Company has employed a consulting firm, whose owner is a relative of an
executive officer of the Company. Fees to the firm totaled $64,000 from
inception through June 30, 1998.
The Company has agreements with three executive officers to provide for
certain payments to these executives upon a change in control of the Company, as
defined, provided they continue to provide certain services to the Company.
(7) INCOME TAXES
At June 30, 1998, the Company had available net operating loss
carryforwards ("NOL") of approximately $22,500,000 and $22,200,000 for Federal
and state income tax reporting purposes, respectively, which are available to
offset future Federal and state taxable income, if any, through fiscal 2013 and
2005, respectively. The Company also has research and development tax credit
carryforwards of approximately $721,000 and $127,000 for Federal and state
income tax reporting purposes, respectively, which are available to reduce
Federal and state income taxes, if any, through fiscal 2013 and 2005,
respectively.
The Tax Reform Act of 1986 (the Act) provides for a limitation on the
annual use of NOL and research and development tax credit carryforwards
(following certain ownership changes, as defined by the Act) which could
significantly limit the Company's ability to utilize these carryforwards. The
Company has experienced various ownership changes, as defined by the Act, as a
result of past financings. Accordingly, the Company's
F-13
92
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
ability to utilize the aforementioned carryforwards may be limited.
Additionally, because U.S. tax laws limit the time during which these
carryforwards may be applied against future taxes, the Company may not be able
to take full advantage of these attributes for Federal income tax purposes.
The tax effects of temporary differences that give rise to significant
portions of the deferred tax assets and deferred tax liability at June 30, 1997
and 1998 are presented below:
JUNE 30,
---------------------------
1997 1998
----------- ------------
Deferred tax assets:
Net operating loss carryforwards............... $ 5,382,992 8,992,994
Tax credit carryforward........................ 334,365 847,462
Accrual to cash adjustment..................... 572,548 970,407
Deferred compensation.......................... -- 214,764
----------- ------------
Total gross deferred tax assets........ 6,289,905 11,025,627
Less valuation allowance....................... (6,284,988) (11,018,100)
----------- ------------
Total deferred tax assets.............. 4,917 7,527
----------- ------------
Deferred tax liability:
Equipment, due to differences in
depreciation................................ 4,917 7,527
----------- ------------
Total deferred tax liability........... 4,917 7,527
----------- ------------
Net deferred taxes..................... $ -- --
=========== ============
The net change in the valuation allowance for the years ended June 30,
1996, 1997 and 1998 were increases of $740,319, $2,422,015 and $4,733,112,
respectively, related primarily to additional net operating losses incurred by
the Company which are not currently deductible.
(8) COMMITMENTS AND CONTINGENCIES
The Company has leases for office space in New Jersey and the United
Kingdom, under which the Company incurred rental expense for fiscal 1996, 1997
and 1998 of $92,874, $107,314 and $124,019, respectively.
Minimum lease payments under noncancellable leases are as follows:
YEAR ENDED
JUNE 30,
----------
1999.................................................... $149,064
2000.................................................... 83,547
2001.................................................... 15,315
========
$247,926
========
The Company had an outstanding $150,000 irrevocable commercial letter of
credit as of June 30, 1998. The contract amount of this letter of credit
approximates its fair value. The letter of credit is secured by a $150,000
certificate of deposit which is required to be held at the financial institution
which issued the letter of credit.
F-14
93
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
(9) MANDATORILY REDEEMABLE CONVERTIBLE PREFERRED STOCK AND CONVERTIBLE PREFERRED
STOCK
The Company completed the sale of Series A, Series B, Series C and Series D
in fiscal 1991, 1993, 1994, 1996, 1997 and 1998 (see note 5). Aggregate net cash
proceeds from such equity transactions totaled $17,626,402 ($18,661,410
including cash received for promissory notes and accrued interest, all converted
to preferred stock).
The holders of Series A, Series B, Series C and Series D vote together with
all other classes and series of stock of the Company as a single class on all
actions to be taken by the stockholders of the Company. Each share of preferred
stock entitles the holder to an equal number of votes as the number of common
shares into which each share of preferred stock is convertible.
The holders of Series A, Series B and Series C shall be entitled to
receive, out of funds legally available, when and if declared by the Board of
Directors, quarterly dividends at the rate per annum of $0.12 per share of
Series A, $0.20 per share of Series B and $0.27 per share of Series C. The
dividends accrue daily, whether or not earned or declared, and are cumulative.
Cumulative dividends in arrears at June 30, 1998 were $3,423,057 in the
aggregate for Series A, B and C. Such amounts have been accreted in the
accompanying consolidated financial statements for the respective periods in
which they accumulated. As of June 30, 1998, no such dividends have been
declared. Due to the mandatory redemption feature, these securities are
classified at their accreted value outside of stockholders' deficit in the
accompanying consolidated balance sheets.
The holders of Series A, Series B, Series C and Series D are entitled to
liquidation preferences over all other types of capital stock in accordance with
the following amounts (same per share amounts as paid by such preferred
stockholders): $1.50 per share for the Series A, $2.50 per share for the Series
B, $3.40 per share for the Series C and $11.06 per share for the Series D plus
in the case of each share of Series A, Series B and Series C, an amount equal to
all cumulative dividends unpaid (whether or not declared) and any other
dividends declared but not paid. The computation of the dividends will be
computed to the date payment is made available.
The holders of Series A, Series B, Series C and Series D have the right at
any time to convert any share of preferred stock into fully-paid nonassessable
shares of common stock at a conversion price of $1.50, $2.50, $3.40 and $11.06
per share, respectively. If at any time the Company effects a firm commitment
underwritten public offering of shares of common stock in which the aggregate
price paid for such shares by the public is at least $10,000,000 and the price
paid per share is at least $7.50 per share then effective on the closing of the
sale of such shares, all outstanding shares of Series A, Series B, and Series C
automatically convert to shares of common stock. In the case of Series D, if the
Company effects a firm commitment underwritten public offering of shares of
common stock in which the aggregate price paid for such shares by the public is
at least $10,000,000 and the price paid per share is at least $11.06 or the
Company's common stock is publicly traded on a national securities exchange and
the average of the closing sale prices for the common stock within any 10
consecutive trading day period is $11.06 or more, then all outstanding shares of
Series D automatically convert to shares of common stock.
F-15
94
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
Commencing January 27, 2000, the Company is required to redeem the
outstanding shares of Series A, Series B and Series C at liquidation prices,
including cumulative dividends, in the percentages per year shown in the
following schedule:
2000........................................................ 10%
2001........................................................ 15%
2002........................................................ 25%
2003........................................................ 25%
2004........................................................ 25%
These mandatory redemptions are subject to waiver by holders of 60% of the
shares of Series A, B and C in the aggregate.
(10) COMMON STOCK AND COMMON STOCK OPTIONS
The following transactions were consummated using prices determined by the
Board of Directors to be the deemed fair value at the date of the respective
transaction:
- In June 1985, the Company issued 153,000 shares of common stock to
executive officers for the price of $0.03 per share.
- In October 1990, the Company issued 562,500 shares of common stock to an
executive officer and consultant for the price of approximately $.26 per
share.
- In July 1994, the Company issued 20,000 shares of common stock to an
executive officer for the price of $.34 per share as part of a stock
subscription and shareholder agreement.
- In January 1995, the Company issued 80,000 shares of common stock to an
executive officer for the price of $.34 per share as part of the
aforementioned subscription and shareholder agreement.
- In December 1995, the Company issued 50,000 shares of common stock to
Advanced Technology Ventures III, LP for the price of $.15 per share upon
exercise of stock warrants granted in December 1990.
In December 1990, the Company adopted the 1990 Stock Plan (the 1990 Plan)
whereby incentive and nonqualified stock options may be granted to directors,
employees, and consultants to purchase an aggregate of 374,187 (increased to
1,700,000 in 1997) shares of the Company's common stock. The incentive stock
options are to be granted at no less than fair market value at the measurement
date (usually the grant date), as determined by the Board of Directors. The
nonqualified option prices are to be determined by the Board of Directors and
may be less than the fair market value. The options are exercisable generally
for a period of ten years after the date of grant and generally vest over a
five-year period which in some cases may be accelerated on the occurrence of
certain future events.
The Company applies APB Opinion No. 25 in accounting for the 1990 Plan.
Certain employees of the Company were granted options to acquire 333,000 shares
of common stock at exercise prices ranging from $1.00 to $3.00 per share during
fiscal 1998. Certain employees of the Company were granted performance-based
options to acquire 192,000 shares of common stock at exercise prices ranging
from $.34 to $1.00 per share during fiscal 1995, 1996, 1997 and 1998 for which
the measurement date occurred during fiscal 1998 when the Company amended these
option terms to include a fixed vesting schedule (at the end of five years from
the original date of grant) without regard for the performance criteria. The
exercise price of all of these options was equal to the deemed fair value of the
common stock on the date of grant, as determined by the Board of Directors.
However, for financial reporting purposes, the difference between the deemed
fair value
F-16
95
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
and the respective exercise prices at the measurement dates has been recorded as
deferred compensation in the amount of $1,461,730 and is being amortized over
the five-year vesting period. Compensation expense for the aforementioned
options aggregated $536,909 for fiscal 1998.
Had the Company determined compensation cost for its stock options under
SFAS 123 using the minimum value method at the measurement date, the Company's
net loss allocable to common stockholders and net loss per share allocable to
common stockholders would have been increased to the pro forma amounts indicated
below:
YEAR ENDED JUNE 30,
-----------------------------------------
1996 1997 1998
----------- ----------- -----------
Net loss allocable to common
stockholders:
As reported....................... $(2,542,760) (6,117,770) (11,400,074)
Pro forma......................... (2,544,606) (6,133,798) (11,529,952)
Basic and diluted net loss per share
allocable to common stockholders:
As reported....................... $ (3.01) (5.79) (10.70)
Pro forma......................... (3.01) (5.80) (10.82)
Pro forma net loss allocable to common stockholders and net loss per share
allocable to common stockholders reflects only options granted in fiscal 1996,
1997 and 1998. Therefore, the full impact of calculating compensation cost for
stock options under SFAS No. 123 is not reflected in the pro forma net loss
allocable to common stockholders and net loss per share allocable to common
stockholders amounts presented above because compensation cost is reflected over
the options' vesting period and compensation expense for options granted prior
to June 30, 1995 is not considered.
A summary of activity under the 1990 Plan is as follows:
PRICE
SHARES PER SHARE
--------- ------------
Balance, June 30, 1995..................................... 522,187 $0.15 -- 0.34
Granted.................................................. 198,000 0.70
Cancelled................................................ (7,500) 0.25
---------
Balance, June 30, 1996..................................... 712,687 0.15 -- 0.70
Granted.................................................. 75,500 0.70
Cancelled................................................ (54,200) 0.15 -- 0.34
---------
Balance, June 30, 1997..................................... 733,987 0.15 -- 0.70
Granted.................................................. 824,500 0.70 -- 8.00
Cancelled................................................ (23,000) 0.70 -- 3.00
---------
Balance, June 30, 1998..................................... 1,535,487 0.15 -- 8.00
=========
Shares exercisable at June 30, 1998........................ 509,757 $0.15 -- 3.00
=========
Options granted in fiscal 1998 include 175,000 options which have a per
share exercise price equal to the fair market value on the date of the
occurrence of certain future events.
F-17
96
ANTHRA PHARMACEUTICALS, INC.
AND SUBSIDIARY
(A Development Stage Enterprise)
Notes to Consolidated Financial Statements -- (Continued)
At June 30, 1998, the 1990 Plan had the following options outstanding and
exercisable by price range as follows:
OUTSTANDING EXERCISABLE
----------------------------------- -------------------
WEIGHTED WEIGHTED WEIGHTED
AVERAGE AVERAGE AVERAGE
RANGE OF NUMBER REMAINING EXERCISE NUMBER EXERCISE
EXERCISE OF CONTRACTUAL PRICE PER OF PRICE PER
PRICES SHARES LIFE SHARE SHARES SHARE
- ---------- --------- ----------- --------- ------- ---------
$0.15-0.70 724,987 5 years $0.37 483,087 $0.23
1.00-3.00 357,500 9 years 2.04 26,670 3.00
8.00 278,000 10 years 8.00 -- --
FMV(1) 175,000 10 years FMV(1) -- --
--------- -------
1,535,487 509,757
========= =======
- ---------------
(1) Exercise price is equal to the fair market value on the date of the
occurrence of certain future events.
The per share weighted-average fair value of stock options granted during
fiscal 1996, 1997 and 1998 was $.28, $.28 and $5.29, respectively, on the
measurement date using the minimum value method, with the following
weighted-average assumptions:
1996 1997 1998
---- ---- ----
Expected life in years................................ 8 8 8
Risk-free interest rate............................... 6.5% 6.5% 6.0%
Volatility............................................ 0% 0% 0%
Expected dividend yield............................... 0% 0% 0%
(11) 401(K) SALARY REDUCTION PLAN
In June 1998, the Company adopted a 401(k) Salary Reduction Plan (the
401(k) Plan) available to all employees meeting certain eligibility
requirements. The 401(k) Plan permits participants to contribute up to 15% of
their annual salary not to exceed the limits established by the Internal Revenue
Code. All contributions made by participants vest immediately in the
participant's account. The Company did not make any matching contributions in
fiscal 1998 in accordance with the terms of the 401(k) Plan.
(12) SUBSEQUENT EVENT (UNAUDITED)
Initial Public Offering
On September 24, 1998, the Board of Directors authorized the filing of a
registration statement with the SEC for the sale of up to 2,300,000 units, each
unit consisting of one share of common stock and one warrant to purchase one
share of common stock.
F-18
97
- ------------------------------------------------------
- ------------------------------------------------------
NO DEALER, SALESPERSON OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO GIVE ANY
INFORMATION OR TO MAKE ANY REPRESENTATIONS NOT CONTAINED IN THIS PROSPECTUS,
AND, IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS MUST NOT BE RELIED
UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY OR THE UNDERWRITER. THIS
PROSPECTUS DOES NOT CONSTITUTE AN OFFER OF ANY SECURITIES OTHER THAN THOSE TO
WHICH IT RELATES OR AN OFFER TO SELL, OR A SOLICITATION OF AN OFFER TO BUY, TO
ANY PERSON IN ANY JURISDICTION WHERE SUCH OFFER OR SOLICITATION WOULD BE
UNLAWFUL. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER
SHALL, UNDER ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THE INFORMATION
CONTAINED HEREIN IS CORRECT AS OF ANY TIME SUBSEQUENT TO THE DATE HEREOF.
------------------
TABLE OF CONTENTS
PAGE
----
Prospectus Summary.................... 3
Risk Factors.......................... 8
Use of Proceeds....................... 22
Dividend Policy....................... 22
Capitalization........................ 23
Dilution.............................. 24
Selected Consolidated Financial
Data................................ 26
Management's Discussion and Analysis
of Financial Condition and Results
of Operations....................... 27
Business.............................. 32
Management............................ 56
Principal Stockholders................ 65
Certain Relationships and Related
Transactions........................ 67
Description of Securities............. 68
Shares Eligible for Future Sale....... 72
Underwriting.......................... 74
Legal Matters......................... 76
Experts............................... 76
Additional Information................ 76
Index to Consolidated Financial
Statements.......................... F-1
UNTIL , 1998 (25 CALENDAR DAYS AFTER THE DATE OF THIS
PROSPECTUS), ALL DEALERS EFFECTING TRANSACTIONS IN THE REGISTERED SECURITIES,
WHETHER OR NOT PARTICIPATING IN THIS DISTRIBUTION, MAY BE REQUIRED TO DELIVER A
PROSPECTUS. THIS DELIVERY REQUIREMENT IS IN ADDITION TO THE OBLIGATIONS OF THE
DEALERS TO DELIVER A PROSPECTUS WHEN ACTING AS UNDERWRITERS AND WITH RESPECT TO
THEIR ALLOTMENTS OR SUBSCRIPTIONS.
- ------------------------------------------------------
- ------------------------------------------------------
- ------------------------------------------------------
- ------------------------------------------------------
2,000,000 UNITS
EACH UNIT CONSISTING OF
ONE SHARE OF COMMON STOCK AND
ONE CLASS A REDEEMABLE
COMMON STOCK
PURCHASE WARRANT
[ANTHRA PHARMACEUTICALS, INC. LOGO]
--------------------
PROSPECTUS
--------------------
JANSSEN/MEYERS
ASSOCIATES, L.P.
, 1998
- ------------------------------------------------------
- ------------------------------------------------------
98
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
Other expenses in connection with the issuance and distribution of the
securities to be registered hereunder, all of which will be paid by the
Registrant, will be substantially as follows:
ITEM AMOUNT
- ---- ----------
Commission Registration Fee................................. $ 8,230.50
American Stock Exchange Listing Fee......................... $25,000.00
NASD Filing Fee............................................. $ +
*Blue Sky Fees and Expenses (including legal fees).......... $ +
*Accounting Fees and Expenses............................... $ +
*Legal Fees and Expenses.................................... $ +
*Consulting Fees............................................ $ +
*Printing and Engraving..................................... $ +
*Registrar and Transfer Agent's Fees........................ $ +
*Underwriter's Non-Accountable Expense Allowance............ $ +
*Underwriter's Consulting Agreement......................... $ +
*Underwriter's Expenses..................................... $ +
*Miscellaneous Expenses..................................... $ +
----------
Total............................................. $ +
==========
- ---------------
* Estimated
+ To be filed by amendment.
ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS.
The Amended Certificate of Incorporation provides that a Director of the
Company shall not be personally liable to the Company or its stockholders for
monetary damages for breach of the fiduciary duty as a director, except for
liability, to the extent imposed by applicable law, for: (i) any breach of the
Director's duty of loyalty to the Company or its stockholders; (ii) acts or
omissions not in good faith or which involve intentional misconduct or a knowing
violation of law; (iii) liability for payments of dividends or stock purchases
or redemptions in violation of Section 174 of the DGCL; or (iv) any transaction
from which the Director derived an improper personal benefit. In addition, the
Amended Certificate of Incorporation provides that the Company shall, to the
fullest extent permitted by Section 145 of the DGCL, as the same exists or may
hereafter be amended and supplemented, indemnify any and all persons who it
shall have the power to indemnify under such law from and against any and all of
the expenses, liabilities, or other matters referred to in or covered by said
section, and the indemnification provided for therein is not exclusive of any
other rights to which those indemnified may be entitled under any Bylaw,
agreement, vote of stockholders or disinterested Directors, or otherwise, both
as to action in his official capacity and as to action in another capacity while
holding such office, and continues as to a person who has ceased to be a
Director, officer, employee, or agent and shall inure to the benefit of the
heirs, executors and administrators of such a person.
The right to indemnification set forth above includes the right to be paid
by the Company the expenses (including attorneys' fees) incurred in defending
any such proceeding in advance of its final disposition; provided, however,
that, to the extent required by the DGCL, an advancement of expenses incurred by
an indemnitee shall be made only upon delivery to the Company of an undertaking,
by or on behalf of such indemnitee, to repay all amounts so advanced if it shall
ultimately be determined by final judicial decision from which there is not
further right to appeal that such indemnitee is not entitled to be indemnified
for such expenses under the relevant provisions of the DGCL or otherwise. The
rights to indemnification and to the advancement of expenses conferred are
contract rights and continue as to an indemnitee who has ceased to be
II-1
99
a Director, officer, employee or agent and inures to the benefit of the
indemnitee's heirs, executors and administrators.
Section 145 of the DGCL provides that indemnification is permissible only
when the Director, officer, employee, or agent acted in good faith and in a
manner such person reasonably believed to be in or not opposed to the best
interests of the Company, and, with respect to any criminal action or
proceeding, had no reasonable cause to believe the conduct was unlawful. Section
145 of the DGCL also precludes indemnification in respect of any claim, issue,
or matter as to which an officer, Director, employee, or agent shall have been
adjudged to be liable to the Company unless and only to the extent that the
Delaware Court of Chancery or the court in which such action or suit was brought
shall determine upon application that, despite such adjudication of liability
but in view of all the circumstances of the case, such person is fairly and
reasonably entitled to indemnity for such expenses which the Delaware Court of
Chancery or such other court shall deem proper.
The Company has agreed to indemnify the Underwriter and its controlling
persons, and the Underwriter has agreed to indemnify the Company and its
controlling persons, against certain liabilities, including liabilities under
the Securities Act. Reference is made to the Underwriting Agreement filed as
part of the Exhibits hereto.
For information regarding the Company's undertaking to submit to
adjudication the issue of indemnification for violation of the securities laws,
see Item 17 hereof.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES.
On September 20, 1995, the Company issued 271,276 shares of its Series D
Convertible Preferred Stock to Schering Berlin Venture Corporation at an
aggregate price of approximately $3.0 million pursuant to a Series D Convertible
Preferred Stock Purchase Agreement between such parties. The sale of stock to
Schering Berlin Venture Corporation was an integral part of, and condition
precedent to, the Development Agreement. In July 1996, the Company and Schering
AG, Germany converted the Development Agreement to the Support Agreement for
which Schering AG, Germany paid $3.5 million in consideration for its release
from the Development Agreement and 200,000 shares of the Company's Series D
Convertible Preferred Stock, which shares Schering AG, Germany subsequently
converted to Common Stock.
On April 17, 1997, the Company issued 67,819 shares of its Series D
Convertible Preferred Stock to Almirall at an aggregate price of approximately
$750,000 in connection with the Almirall Agreement.
On October 14, 1997, the Company issued 300,000 shares of its Series D
Convertible Preferred Stock to Nycomed at an aggregate price of $4.5 million in
connection with the Nycomed Agreement.
Exemption from registration for each transaction described above was
claimed pursuant to Section 4(2) of the Securities Act regarding transactions by
an issuer not involving any public offering.
II-2
100
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULE.
EXHIBITS:
EXHIBIT
NUMBER DESCRIPTION OF EXHIBIT
- ------- ----------------------
1 Form of Underwriting Agreement by and between the
Underwriter and the Company.#
3.1 Amended and Restated Certificate of Incorporation of the
Company, as amended.#
3.2 Bylaws of the Company.#
4.1 Reference is made to Exhibits 3.1 and 3.2.
4.2 Specimen Common Stock Certificate.#
4.3 Fifth Amended and Restated Registration Rights Agreement,
dated October 14, 1997, by and among the Company, Advanced
Technology Ventures III, L.P., Sevin Rosen Fund III, L.P.,
Allstate Insurance Company, Allstate Life Insurance Company,
Aperture Associates, L.P., Schering Berlin Venture
Corporation, Prodesfarma, S.A. and Nycomed Pharma AS.#
4.4 Form of Unit and Warrant Agreement between the Company and
American Stock Transfer & Trust Company.#
4.5 Form of Underwriter's Option Agreement for Units by and
between the Company and the Underwriter.#
4.6 Form of Warrant Certificate (incorporated by reference into
Exhibit 4.4).#
4.7 Form of Unit Certificate (incorporated by reference into
Exhibit 4.4).#
5 Form of Opinion of Morrison & Foerster LLP.#
10.1 Agreement, dated November 6, 1990, by and between the
Company and Dana-Farber Cancer Institute.*#
10.2 Letter agreement, dated December 5, 1990, by and between the
Company and Michael C. Walker.#
10.3 Letter agreement, dated December 5, 1990, by and between the
Company and Mervyn Israel.#
10.4 Exclusive Supply Agreement, dated June 1, 1991, by and
between the Company and Omnichem S.A.*#
10.5 Termination, Settlement and Investment Agreement, dated July
16, 1996, by and between the Company and Schering AG,
Germany (f/k/a Schering AG).*#
10.6 Agreement, dated September 1996, between the Company and
Allen L. Thunberg.#
10.7 Agreement, dated September 1996, between the Company and
Michael C. Walker.#
10.8 [Intentionally omitted].
10.9 Exclusive License Agreement, dated April 17, 1997, by and
between the Company and Prodesfarma, S.A. (a/k/a Almirall
Prodesfarma, S.A.).*#
10.10 Sublease, dated July 2, 1997, by and between the Company and
the Presbyterian Homes of New Jersey Foundation, Inc.#
10.11 Development Agreement, dated July 15, 1997, by and between
the Company and Medeva California Inc.*#
10.12 Supply Agreement, dated September 11, 1997, by and between
the Company and Genchem Pharma Ltd.*#
10.13 1990 Stock Plan, as amended.#
10.14 Exclusive License, Sale and Distribution Agreement, dated
October 14, 1997, by and between the Company and Nycomed
Pharma AS.*#
10.15 Term Sheet, dated December 12, 1997, by and among Berlex
Laboratories, Inc., the Company and Leiras Oy.*#
II-3
101
EXHIBIT
NUMBER DESCRIPTION OF EXHIBIT
- ------- ----------------------
10.16 Underlease of Suite B Second Floor Premises known as The
Malt House, Malt House Square, Princes Risborough,
Buckinghamshire, dated December 27, 1997, by and between the
Company and Allen-Martin Conservation Limited.#
10.17 ABR Benefits Services, Inc. Regional Prototype Defined
Contribution Plan and Trust, adopted by the Company and
effective as of June 1, 1998.#
10.18 Adoption Agreement for the ABR Benefits Services, Inc.
Regional Prototype Standardized Cash or Deferred Profit
Sharing Plan and Trust (with Pairing Provisions), dated June
1, 1998.#
10.19 Option Agreement, dated July 6, 1998, by and between the
Company, Berlex Laboratories, Inc., and Leiras Oy.#
10.20 Form of Financial Consultant Agreement between the
Underwriter and the Company.#
10.21 Development and Commercialization Agreement, dated September
30, 1998, among Leiras Oy, Berlex Laboratories, Inc. and the
Company (reference is made to Exhibit A to Exhibit 10.19),
as amended by the letter agreement, dated September 30,
1998, among Leiras Oy, Berlex Laboratories, Inc. and the
Company.[ ]
10.22 Manufacturing Agreement, dated September 30, 1998, between
Leiras Oy and the Company (reference is made to Exhibit B to
Exhibit 10.19), as amended by the letter agreement, dated
September 30, 1998, among Leiras Oy, Berlex Laboratories,
Inc. and the Company (reference is made to Exhibit 10.21).[
]
21 Subsidiary.#
23.1 Consent of KPMG Peat Marwick LLP. [ ]
23.2 Consent of MedProbe, Inc.#
23.3 Consent of Morrison & Foerster LLP (incorporated by
reference into Exhibit 5).#
24 Powers of Attorney (set forth on signature page to the
Registration Statement or included in Exhibit 24 to
Amendment No. 1 to the Registration Statement).#
27.1 Summary Financial Data Schedule.#
- ---------------
+ To be filed by amendment.
* Confidential treatment has been requested with respect to certain portions of
this Exhibit. Omitted portions will be filed separately with the Commission.
# Previously filed.
[ ] Filed herewith.
ITEM 17. UNDERTAKINGS.
The undersigned Registrant hereby undertakes to provide to the Underwriter
at the closing specified in the Underwriting Agreement certificates in such
denomination and registered in such names as required by the Underwriter to
permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities arising under the Securities Act
may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the foregoing provisions, or otherwise, the Registrant
has been advised that in the opinion of the Commission such indemnification is
against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such
liabilities (other than the payment by the Registrant of expenses incurred or
paid by a director, officer or controlling person of the Registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered in the Offering, the Registrant will, unless in the opinion of its
counsel the matter has been settled by controlling precedent, submit to a court
of appropriate jurisdiction the question whether such indemnification by it is
against public policy as expressed in the Securities Act and will be governed by
the final adjudication of such issue.
II-4
102
The undersigned Registrant hereby undertakes that:
(1) For the purposes of determining any liability under the Securities
Act, the information omitted from the form of prospectus filed as part of
the Registration Statement in reliance upon Rule 430A and contained in a
form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or
(4), or 497(h) under the Securities Act, shall be deemed to be part of the
Registration Statement as of the time it was declared effective.
(2) For the purposes of determining any liability under the Securities
Act, each post-effective amendment that contains a form of prospectus shall
be deemed to be a new registration statement relating to the securities
offered therein and the offering of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being
made, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the
Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after
the effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set forth
in the registration statement. Notwithstanding the foregoing, any
increase or decrease in volume of securities offered (if the total
dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated
maximum offering range may be reflected in the form of prospectus filed
with the Commission pursuant to Rule 424(b) if, in the aggregate, the
changes in volume and price represent no more than 20 percent change in
the maximum aggregate offering price set forth in the "Calculation of
Registration Fee" table in the effective registration statement.
(iii) To include any material information with respect to the plan
of distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement.
(2) That, for the purpose of determining any liability under the
Securities Act of 1933, each such post-effective amendment shall be deemed
to be a new registration statement relating to the securities offered
therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment
any of the securities being registered which remain unsold at the
termination of the offering.
II-5
103
SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant has duly
caused this Amendment to Registration Statement on Form S-1 to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of New York,
State of New York, on October 1, 1998.
ANTHRA PHARMACEUTICALS, INC.
By: /s/ MICHAEL C. WALKER
------------------------------------
Michael C. Walker
President and Chief Executive
Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Act, this Amendment to
Registration Statement on Form S-1 has been signed by the following persons in
the capacities and on the dates indicated.
NAME AND SIGNATURE TITLE DATE
------------------ ----- ----
/s/ MERVYN ISRAEL* Director, Chairman of the Board and October 1, 1998
- ------------------------------------------ Secretary
Mervyn Israel
/s/ MICHAEL C. WALKER Director, Chief Executive Officer and October 1, 1998
- ------------------------------------------ President (Principal Executive
Michael C. Walker Officer)
/s/ KAREN KRUMEICH* Chief Financial Officer and Vice October 1, 1998
- ------------------------------------------ President -- Finance (Principal
Karen Krumeich Financial and Accounting Officer)
/s/ PAUL G. GOODING* Director October 1, 1998
- ------------------------------------------
Paul G. Gooding
/s/ WILLIAM ENGBERS* Director October 1, 1998
- ------------------------------------------
William Engbers
*By: /s/ MICHAEL C. WALKER
- ------------------------------------------
Michael C. Walker
Attorney-in-Fact
II-6
104
INDEX OF EXHIBITS
SEQUENTIALLY
EXHIBIT NUMBERED
NUMBER DESCRIPTION OF EXHIBIT PAGE
- ------- ---------------------- ------------
1 Form of Underwriting Agreement by and between the
Underwriter and the Company.#
3.1 Amended and Restated Certificate of Incorporation of the
Company, as amended.#
3.2 Bylaws of the Company.#
4.1 Reference is made to Exhibits 3.1 and 3.2.
4.2 Specimen Common Stock Certificate.#
4.3 Fifth Amended and Restated Registration Rights Agreement,
dated October 14, 1997, by and among the Company, Advanced
Technology Ventures III, L.P., Sevin Rosen Fund III, L.P.,
Allstate Insurance Company, Allstate Life Insurance Company,
Aperture Associates, L.P., Schering Berlin Venture
Corporation, Prodesfarma, S.A. and Nycomed Pharma AS.#
4.4 Form of Unit and Warrant Agreement between the Company and
American Stock Transfer & Trust Company.#
4.5 Form of Underwriter's Option Agreement for Units by and
between the Company and the Underwriter.#
4.6 Form of Warrant Certificate (incorporated by reference into
Exhibit 4.4).#
4.7 Form of Unit Certificate (incorporated by reference into
Exhibit 4.4).#
5 Form of Opinion of Morrison & Foerster LLP.#
10.1 Agreement, dated November 6, 1990, by and between the
Company and Dana-Farber Cancer Institute.*#
10.2 Letter agreement, dated December 5, 1990, by and between the
Company and Michael C. Walker.#
10.3 Letter agreement, dated December 5, 1990, by and between the
Company and Mervyn Israel.#
10.4 Exclusive Supply Agreement, dated June 1, 1991, by and
between the Company and Omnichem S.A.*#
10.5 Termination, Settlement and Investment Agreement, dated July
16, 1996, by and between the Company and Schering AG,
Germany (f/k/a Schering AG).*#
10.6 Agreement, dated September 1996, between the Company and
Allen L. Thunberg.#
10.7 Agreement, dated September 1996, between the Company and
Michael C. Walker.#
10.8 [Intentionally omitted].
10.9 Exclusive License Agreement, dated April 17, 1997, by and
between the Company and Prodesfarma, S.A. (a/k/a Almirall
Prodesfarma, S.A.).*#
10.10 Sublease, dated July 2, 1997, by and between the Company and
the Presbyterian Homes of New Jersey Foundation, Inc.#
10.11 Development Agreement, dated July 15, 1997, by and between
the Company and Medeva California Inc.*#
10.12 Supply Agreement, dated September 11, 1997, by and between
the Company and Genchem Pharma Ltd.*#
10.13 1990 Stock Plan, as amended.#
10.14 Exclusive License, Sale and Distribution Agreement, dated
October 14, 1997, by and between the Company and Nycomed
Pharma AS.*#
105
SEQUENTIALLY
EXHIBIT NUMBERED
NUMBER DESCRIPTION OF EXHIBIT PAGE
- ------- ---------------------- ------------
10.15 Term Sheet, dated December 12, 1997, by and among Berlex
Laboratories, Inc., the Company and Leiras Oy.*#
10.16 Underlease of Suite B Second Floor Premises known as The
Malt House, Malt House Square, Princes Risborough,
Buckinghamshire, dated December 27, 1997, by and between the
Company and Allen-Martin Conservation Limited.#
10.17 ABR Benefits Services, Inc. Regional Prototype Defined
Contribution Plan and Trust, adopted by the Company and
effective as of June 1, 1998.#
10.18 Adoption Agreement for the ABR Benefits Services, Inc.
Regional Prototype Standardized Cash or Deferred Profit
Sharing Plan and Trust (with Pairing Provisions), dated June
1, 1998.#
10.19 Option Agreement, dated July 6, 1998, by and between the
Company, Berlex Laboratories, Inc., and Leiras Oy.#
10.20 Form of Financial Consultant Agreement between the
Underwriter and the Company.#
10.21 Development and Commercialization Agreement, dated September
30, 1998, among Leiras Oy, Berlex Laboratories, Inc. and the
Company (reference is made to Exhibit A to Exhibit 10.19),
as amended by the letter agreement, dated September 30,
1998, among Leiras Oy, Berlex Laboratories, Inc. and the
Company.[ ]
10.22 Manufacturing Agreement, dated September 30, 1998, between
Leiras Oy and the Company (reference is made to Exhibit B to
Exhibit 10.19), as amended by the letter agreement, dated
September 30, 1998, among Leiras Oy, Berlex Laboratories,
Inc. and the Company (reference is made to Exhibit 10.21).[
]
21 Subsidiary.#
23.1 Consent of KPMG Peat Marwick LLP.[ ]
23.2 Consent of MedProbe, Inc.#
23.3 Consent of Morrison & Foerster LLP (incorporated by
reference into Exhibit 5).#
24 Powers of Attorney (set forth on signature page to the
Registration Statement or included in Exhibit 24 to
Amendment No. 1 to the Registration Statement).#
27.1 Summary Financial Data Schedule.#
- ---------------
+ To be filed by amendment.
* Confidential treatment has been requested with respect to certain portions of
this Exhibit. Omitted portions will be filed separately with the Commission.
# Previously filed.
[ ] Filed herewith.