Gentium Spa (AMEX:GNT)
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Gentium S.p.A. (AMEX:GNT) (the "Company") today reported
financial results for the three- and six-month periods ended June 30,
2005. Highlights of the second quarter of 2005 and recent weeks
include:
-- Completed an initial public offering of 2.7 million American
Depositary Shares (ADS) (including the exercise of part of the
underwriters over-allotment option), which are listed on the
American Stock Exchange (1 ADS = 1 share), and raised gross
proceeds of $24.3 million;
-- Received Fast Track designation from the U.S. Food and Drug
Administration (FDA) for the company's lead product candidate,
Defibrotide for the treatment of severe Veno-Occlusive
Disease (VOD) with multiple organ failure ("Severe VOD");
-- FDA deemed the Company's Chemistry, Manufacturing & Controls
(CMC) submission to be adequate for initiation of Phase III
studies with Defibrotide for treating Severe VOD.
Laura Ferro, M.D., chairman and chief executive officer of Gentium
said, "We continue to build upon our extensive experience to develop
pharmaceutical products derived from DNA. During the second quarter we
made important progress with clinical development of our lead product
candidate, which addresses a life-threatening disease for which there
are no current treatment options. We are participating in clinical
programs in the U.S. and in Europe, and as a result of the costs
expect to incur losses for the foreseeable future. Our costs and
expenses will be partially offset by revenues derived from the sale of
Defibrotide in Italy for vascular disease with risk of thrombosis and
from the sale of various active pharmaceutical ingredients.
"We look forward to initiating Phase III trials in the U.S. with
Defibrotide for treating Severe VOD pending FDA agreement on our trial
protocol, and to bringing this therapy for such a potentially
devastating complication to market," she added.
Financial Highlights
The Company reports its financial condition and operating results
using U.S. Generally Accepted Accounting Principles (GAAP). The
Company's financial statements are prepared using the Euro (EUR), its
native currency. On June 30, 2005, EUR 1.00 = $1.21.
For the second quarter ended June 30, 2005, compared with the
prior-year's second quarter:
-- Total revenues were EUR 1.2 million, compared to EUR 1.0
million
-- Operating costs and expenses were EUR 2.9 million, compared to
EUR 2.1 million
-- Operating loss was EUR 1.7 million, compared to EUR 1.1
million
-- Interest expense was EUR 2.11 million, compared to EUR 0.03
million
-- Pre-tax loss was EUR 4.3 million, compared to EUR 1.1 million
-- Net loss was EUR 4.3 million, compared to EUR 1.2 million
-- Basic and diluted net loss per share was EUR 0.81 and EUR
0.80, compared to EUR 0.23 and EUR 0.23
For the six months ended June 30, 2005, compared with the
comparable prior-year's six month period:
-- Total revenues were EUR 1.9 million, compared to EUR 1.8
million
-- Operating costs and expenses were EUR 4.8 million, compared to
EUR 3.5 million
-- Operating loss was EUR 2.9 million, compared to EUR 1.7
million
-- Interest expense was EUR 4.26 million, compared to EUR 0.06
million
-- Pre-tax loss was EUR 7.7 million, compared to EUR 1.7 million
-- Net loss was EUR 7.7 million, compared to EUR 1.7 million
-- Basic and diluted net loss per share was EUR 1.50 and EUR
1.48, compared to EUR 0.34 and EUR 0.34
-- Cash used in operating activities was EUR 3.5 million,
compared to EUR 1.0 million
-- Cash and cash equivalents amounted to EUR 10.5 million as of
June 30, 2005. Subsequent to the close of the quarter, the
underwriters of the Company's IPO exercised part of their
over-allotment option, purchasing 300,000 shares for
additional gross proceeds of $2.7 million (approximately EUR
2.2 million).
Dr. Ferro commented, "As we have taken the significant step of
becoming a publicly traded company and have continued to build the
infrastructure to achieve our business objectives, the resulting
increases in operating expenses and interest expense were significant
factors in the size of our losses."
Operating Results and Trends
-- The Company's manufacturing facility was closed from February
through August 2004 for a major upgrade; therefore,
comparisons of 2005 operating results with 2004 results may
not be meaningful.
-- The increase in revenue for the three- and six-month periods
compared with the prior year is primarily the result of the
closing of the Company's manufacturing facility in the
prior-year periods for upgrades.
-- Cost of goods sold increased for the three- and six-month
periods compared with the prior-year period as a result of
increased sales in the 2005 periods and manufacturing overhead
in 2005 that the Company did not have in 2004 because of the
closing of its manufacturing facility for the upgrade.
-- The Company increased its employee headcount from 35 at the
end of 2004 to 52 at June 30, 2005. Other general and
administrative expense increases were primarily the result of
building corporate infrastructure, public company expenses and
an increase in internally provided administrative services to
replace administrative services previously provided by
affiliates, which began to occur in the second quarter.
In the fourth quarter of 2004 and the first quarter of 2005, the
Company issued approximately $8.0 million of convertible notes. As a
result, interest expense increased dramatically in 2005. In
conjunction with the Company's initial public offering, $2.9 million
of these notes were converted into common equity and the balance was
repaid in June and July of 2005. The Company incurred interest expense
of EUR 4.2 million, which included non-cash interest expense of EUR
3.9 million from amortization of the issue discount and issue costs,
on these notes during the six-month period ended June 30, 2005.
Clinical Highlights and Outlook
Commenting on Gentium's clinical progress, Dr. Ferro reported,
"During the second quarter we achieved a number of important clinical
milestones. We were granted Fast Track designation by the FDA for our
initial product candidate, Defibrotide for the treatment of Severe
VOD, which has previously been granted Orphan Drug status. We have a
meeting scheduled with FDA officials later in the third quarter with
the goal of finalizing the protocol for our U.S. Phase III clinical
trial. The upgrades made to our manufacturing facility in 2004
positioned the Company for its CMC submission to the FDA. The
acceptance by the FDA of this submission was a major milestone
necessary for the initiation of this Phase III trial. Upon securing
approval of our Phase III protocol, we expect to begin treating
patients immediately, as we will be using the same centers and
clinical investigators from the Phase II trial."
Dr. Ferro continued, "We have expanded the terms of our licensing
agreement for Defibrotide for the treatment of Severe VOD with our
marketing partner, Sigma Tau, to include Canada, South America and
Central America, in addition to the previously negotiated marketing
rights to the U.S. Sigma Tau also has a right of first refusal to
market Defibrotide for the prevention of VOD in the Americas.
"The Consorzio Mario Negri Sud, a private, non-profit institute in
Italy that carries out basic research in cell biology related to
pharmacology and biomedicine, is conducting a multi-center Phase
II/III clinical trial in Europe and Israel for the treatment of VOD
after stem cell transplant. We expect this trial to include
approximately 340 patients. We also have studies and plans for studies
with Defibrotide for the prevention of VOD underway. We are
co-sponsoring with the European Group for Blood and Marrow
Transplantation a Phase II/III clinical trial in Europe for the use of
Defibrotide to prevent VOD in children. We expect this study to
include 270 patients enrolled by several centers in Europe beginning
later this year. We also expect to start a second Phase II clinical
trial in Europe later this year for use of Defibrotide to prevent VOD
in adults. We expect this trial to include approximately 300 patients
enrolled by several centers in Europe. Finally, we are planning to
begin an exploratory clinical trial of Defibrotide for the treatment
of refractory multiple myeloma by the first quarter of 2006."
About Gentium
Gentium, located in Como, is a biopharmaceutical company focused
on the research, discovery and development of drugs to treat and
prevent a variety of vascular diseases and conditions related to
cancer and cancer treatments.
Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements." In some
cases, you can identify these statements by forward-looking words such
as "may," "might," "will," "should," "expect," "plan," "anticipate,"
"believe," "estimate," "predict," "potential" or "continue," the
negative of these terms and other comparable terminology. These
statements are not historical facts but instead represent the
Company's belief regarding future results, many of which, by their
nature, are inherently uncertain and outside the Company's control. It
is possible that actual results may differ, possibly materially, from
those anticipated in these forward-looking statements. For a
discussion of some of the risks and important factors that could
affect future results, see the discussion in our Prospectus filed with
the Securities and Exchange Commission under Rule 424(b)(4) under the
caption "Risk Factors."
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Gentium S.p.A.
Balance Sheets
(Amounts in EUR) December 31, June 30,
(000's omitted) 2004 2005
---------------- --------------
(unaudited)
ASSETS
Cash and cash equivalents 2,461 10,476
Receivables 9 7
Receivables from related parties 1,490 1,977
Inventories 886 1,384
Prepaid expenses and other current
assets 1,617 832
---------------- --------------
Total Current Assets 6,463 14,676
Property, manufacturing facility and
equipment, at cost 16,152 16,631
Less: Accumulated depreciation 7,609 8,300
---------------- --------------
Property, manufacturing facility and
equipment, net 8,543 8,331
Intangible assets, net 243 252
Other non-current assets 660 623
---------------- --------------
15,909 23,882
================ ==============
LIABILITIES AND SHAREHOLDERS' EQUITY (DEFICIT)
Bank overdraft 100 -
Accounts payable 3,927 3,635
Payables to related parties 1,498 1,131
Short-term bank borrowings 2,690 0
Accrued expenses and other current
liabilities 432 558
Current maturities of long-term debt 2,781 1,814
Convertible notes payable, net of
discount 2,082 827
Deferred income 564 421
---------------- --------------
Total Current Liabilities 14,074 8,386
Long-term debt, net of current
maturities 3,361 2,821
Termination indemnities 548 627
---------------- --------------
Total Liabilities 17,983 11,834
Ordinary Shares (Par value: 1.00.
5,000,000 and 7,759,505 shares issued
and outstanding at December 31, 2004,
and June 30, 2005, respectively) 5,000 7,760
Additional paid-in capital 4,737 23,811
Parent company investment 1,097 1,097
Accumulated deficit (12,908) (20,620)
---------------- --------------
Total Shareholders' Equity (Deficit) (2,074) 12,048
---------------- --------------
15,909 23,882
================ ==============
As of June 30, 2005, EUR 1.00 = $1.21
Gentium S.p.A.
Statements of Operations
Six months ended Three months ended
(Amounts in EUR) June 30, June 30,
(000's omitted except 2004 2005 2004 2005
share data) ----------- ----------- ----------- -----------
(unaudited) (unaudited) (unaudited) (unaudited)
Revenues:
Sales to affiliates 1,072 1,717 657 1,098
Third-party product
sales 253 - 221 -
----------- ----------- ----------- -----------
Total product sales 1,325 1,717 878 1,098
Other income and
revenues 428 217 78 147
----------- ----------- ----------- -----------
Total Revenues 1,753 1,934 956 1,245
Operating costs and
expenses:
Cost of goods sold 871 1,320 578 892
Research and
development 1,529 1,994 894 1,245
Charges from
affiliates 570 581 323 310
General and
administrative 450 911 275 504
Depreciation and
amortization 30 43 19 20
----------- ----------- ----------- -----------
Operating income
(loss) (1,697) (2,915) (1,133) (1,726)
Interest expense (61) (4,255) (30) (2,105)
Other income, net 1 10 - 8
Foreign currency
exchange gain (loss),
net 53 (520) 17 (465)
----------- ----------- ----------- -----------
Pre-tax income (loss) (1,704) (7,680) (1,146) (4,288)
Income tax expense
(benefit):
Current 32 32 16 16
Deferred (37) - - -
----------- ----------- ----------- -----------
(5) 32 16 16
----------- ----------- ----------- -----------
----------- ----------- ----------- -----------
Net loss (1,699) (7,712) (1,162) (4,304)
=========== =========== =========== ===========
Net loss per share:
Basic (0.34) (1.50) (0.23) (0.81)
=========== =========== =========== ===========
Diluted (0.34) (1.48) (0.23) (0.80)
=========== =========== =========== ===========
Weighted average shares used to compute net loss per share:
Basic 5,000,000 5,152,459 5,000,000 5,303,242
=========== =========== =========== ===========
Diluted 5,000,000 5,212,459 5,000,000 5,363,242
=========== =========== =========== ===========
As of June 30, 2005, EUR 1.00 = $1.21
Gentium S.p.A.
Statements of Cash Flows
For the Six Months Ended
(Amounts in EUR) June 30,
(000's omitted) 2004 2005
---------------- --------------
(unaudited) (unaudited)
Cash Flows From Operating Activities:
Net loss (1,699) (7,712)
Adjustments to reconcile net loss to
net cash provided by (used in)
operating activities:
Depreciation and amortization 125 733
Non-cash interest expense - 3,873
Unrealized foreign currency
exchange loss - 569
Stock-based compensation - 106
Services received from parent 0 0
Deferred income tax benefit (37) 32
Changes in operating assets and
liabilities:
Accounts receivable 2,140 (485)
Inventories 273 (498)
Prepaid expenses and other
current assets (729) 229
Other assets 43 37
Accounts payable and accrued
expenses 1,402 (343)
Deferred income (155) (143)
Termination indemnities (23) 79
Income taxes payable (304) 0
---------------- --------------
Net cash provided by
(used in) operating
activities 1,036 (3,523)
Cash Flows From Investing Activities:
Capital expenditures (3,506) (478)
Proceeds from disposal of
intangibles (98) (52)
---------------- --------------
Net cash used in
investing activities (3,604) (530)
Cash Flows From Financing Activities:
Proceeds from long-term debt - 1,465
Debt Issue Costs - (190)
Repayments of long-term debt (200) (307)
Repayment of Series A Senior
Convertible Notes - (3,394)
Proceeds (Repayments) of
short-term borrowings 416 (2,790)
Proceeds from issuance of
common stock, net - 14,584
Proceeds of loan from
affiliate 2,400 -
Repayments of loan from
affiliate - (1,200)
Capital contribution by
shareholder - 3,900
---------------- --------------
Net cash provided by
financing activities 2,616 12,068
Increase in cash and cash equivalents 48 8,015
Cash and cash equivalents, beginning
of period 23 2,461
---------------- --------------
Cash and cash equivalents, end of
period 71 10,476
================ ==============
Supplemental disclosure of cash flow
information:
Cash paid for interest, net of
capitalized amount 28 401
Cash paid for income taxes - -
Supplemental disclosure of non-cash
investing and financing activities:
Equipment acquired under capital lease 127 127
Conversion of notes payable to
stockholders into common stock - 2,408
Valuation of warrants issued in
connection with convertible notes - 597
Value of beneficial conversion feature
in connection with convertible notes
and warrants - 5,192
As of June 30, 2005, EUR 1.00 = $1.21
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