Gentium S.p.A. (NASDAQ: GENT) (the "Company") today reported
financial results for the quarter ended March 31, 2007. Highlights of
the first quarter of 2007 and recent weeks as of June 7, 2007,
include:
-- Continued progress with the Phase III clinical trial in the
U.S. evaluating Defibrotide as a potential treatment of severe
Veno-Occlusive Disease (VOD) with Multiple Organ Failure
(Severe VOD): this study has enrolled 39 patients.
-- Progress with the Phase II/III clinical trials of Defibrotide
in Europe for the prevention of VOD in children. This study is
expected to be conducted in 35 centers and 130 patients have
been enrolled in the trial.
-- Completed Phase I of Phase I/II study of Defibrotide to treat
advanced and refractory multiple myeloma patients, presented
preliminary Phase I data at the Annual Meeting of Society of
Hematology (ASH) 2006. The Company expects to update interim
results from this trial at the upcoming International Myeloma
Workshop in Kos, Greece June 25th to 30th. The Company expects
to present final Phase I data in the second half of 2007.
-- At the American Association of Cancer Research meeting in
April, the Company presented preclinical data to support the
potential mechanism for Defibrotide anti-tumor activity in
multiple myeloma. Two posters presented data that suggest that
Defibrotide may suppress tumor-associated angiogenesis and
tumor dissemination through suppression of heparanase with a
subsequent reduction in the release of stores of growth
factors from the extra-cellular matrix. This, in part, may
explain Defibrotide's anti-MM activity both in vitro and in
vivo.
-- The Company presented updated preclinical data at the World
Congress of Nephrology in April which suggests that
Defibrotide may have activity in diabetic nephropathy. Data
demonstrated that Defibrotide not only has an effect on the
down-regulation of heparanase gene expression, but also
decreases its enzymatic activity in endothelial cells. Since
heparanase is a critical factor in maintaining glomerular
basement membrane integrity and is elevated in diabetic
nephropathy, results suggest that it should be considered for
the management of this disease.
-- The Company completed the acquisition of the Italian marketing
authorizations for Defibrotide and related trademarks, as well
as certain other related assets, from Crinos S.p.A. (Crinos)
for EUR 16 million in cash and other considerations. This
acquisition provides the company control over the distribution
of Defibrotide, as well as enabling Gentium to market directly
or seek a partner in Europe.
-- The Company strengthened its cash position raising $45.2
million net proceeds through a private placement of ordinary
shares in February.
Clinical Highlights and Outlook
Commenting on Gentium's clinical and operational progress during
the quarter, Laura Ferro, M.D., Chairman and Chief Executive Officer,
said, "Over the past quarter the Company has undertaken a series of
complementary initiatives which support progress in research,
clinical, and operations activities. The clinical potential for
Defibrotide continues to expand with additional data to support the
elucidation of the mechanism of action for Defibrotide in cancer, VOD,
as well as metabolically induced indications such as diabetic
nephropathy."
Dr. Ferro continued, "We believe that the next eighteen months
will be pivotal for the Company as we expect to complete accrual and
report results in both the Company's prevention and treatment trials
with Defibrotide. We remain on track to complete patient enrollment in
U.S. Phase III pivotal trial of Defibrotide to treat Severe VOD this
trial during the second half of 2007."
"The acquisition of Crinos assets represented a major milestone
for Gentium as it allows us to better manage this key asset in the
European markets. It also gives us control over its distribution and
the flexibility to market Defibrotide ourselves or alternatively seek
marketing partners in the European market, both of which have long
been strategic objectives. In addition, we strengthened our balance
sheet by raising $45.2 million in net proceeds, which should allow us
to support our clinical development programs and which we believe will
provide us with the capital to complete our Phase III programs."
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 as its
functional currency. On March 31, 2007, EUR 1.00 = $ 1.3318.
For the first quarter ended March 31, 2007 compared with the
prior-year's first quarter:
-- Total revenues were EUR 1.25 million, compared with EUR 0.95
million
-- Operating costs and expenses were EUR 5.42 million, compared
with EUR 3.94 million
-- Research and development expenses, which are included in
operating costs and expenses, were EUR 3.07 million, compared
with EUR 1.67 million
-- Operating loss was EUR 4.17 million, compared with EUR 2.99
million
-- Interest income (expense), net, was EUR 0.26 million, compared
with EUR 0.05 million
-- Net loss was EUR 4.77 million, compared with EUR 3.10 million
-- Basic and diluted net loss per share was EUR 0.36 compared
with EUR 0.32 per share
Operating Results and Trends
The fluctuation in product sales revenues for the three-month
period compared with the prior-year period is primarily due to greater
demand for our products from our two main customers. Sales to
affiliates represented 78% and 99% of the total product sales in the
three months ended March 31, 2007 and 2006, respectively, and
increased 4% to EUR 951 thousand. Sales to third parties increased to
EUR 267 thousand mainly due to higher demand for our active
pharmaceutical ingredient sulglicotide in the Korean market for EUR 82
and due to sales of finished products for EUR 182 directly to
distributors instead of going though Sirton.
Cost of goods sold was EUR 754 thousand for the three month period
ended March 31, 2007 compared to EUR 711 thousand for the comparable
period in 2006. Cost of goods sold as a percentage of product sales
was 61.9% at in the 2007 period compared to 77.7% in the 2006 period.
Research and development spending increased during the three-month
periods in 2007 compared with 2006, primarily due to the costs
associated with the Company's U.S. Phase III trial for the treatment
of Severe VOD. Growth in headcount and outside services to support
increased activity in our clinical trials, primarily contract research
organization expenses and stock-based compensation expense also
contributed to increased research and development expenses.
General and administrative expenses were EUR 1.29 million and EUR
1.3 million for the three month period ended March 31, 2007 and 2006,
respectively. General and administrative expenses for the 2007 period
were thus in line with the comparable period in 2006 and include
personnel costs, facilities related expenses, general corporate
expenses of being a public Company and stock based compensation
expense of EUR 167 thousand.
Interest income (expense), net, increased to EUR 263 in the first
quarter of 2007 over comparable period in 2006. Interest income
amounted to EUR 341 and EUR 85 in the three months ended March 31,
2007 and 2006, respectively, an increase of EUR 256. The increase is a
result of a higher amount of invested funds as a result of the private
placement in 2007. Interest expense totaled EUR 78 and EUR 33 in the
three months ended March 31, 2007 and 2006, respectively.
The Company ended the first quarter of 2007 with EUR 40.41 million
in cash and cash equivalents, compared with cash and cash equivalents
of EUR 10.21 million as of December 31, 2006.
About Gentium
Gentium, S.p.A., located in Como, Italy, 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. Defibrotide, the Company's
lead product candidate, is an investigational drug that has been
granted Orphan Drug status and Fast Track Designation by the U.S. FDA
for the treatment of Severe VOD as well as the prevention of VOD and
Orphan Medicinal Product Designation by the European Commission both
to treat and to prevent VOD.
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 Form 20-F under the
caption "Risk Factors."
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GENTIUM S.p.A.
Balance Sheets
(Amounts in thousands, except share and per share data)
---------------------------
December 31, March 31,
2006 2007
(unaudited)
------------ -----------
ASSETS
Cash and cash equivalents EUR 10,205 EUR 40,407
Restricted Cash 4,000 4,000
Receivables from third parties 227 162
Receivables from related parties 3,478 4,439
Inventories, net 1,499 1,846
Prepaid expenses and other current
assets 1,427 1,316
------------ -----------
Total Current Assets 20,836 52,170
Property, manufacturing facility and
equipment, at cost 18,944 19,171
Less: Accumulated depreciation 9,550 9,783
------------ -----------
Property, manufacturing facility and
equipment, net 9,394 9,388
Intangible assets, net of amortization 586 665
Marketable securities 560 527
Other non-current assets 4,017 4,017
------------ -----------
Total Assets EUR 35,393 EUR 66,767
============ ===========
LIABILITIES AND SHAREHOLDERS' EQUITY
Accounts payable EUR 4,734 EUR 5,263
Payables to related parties 454 875
Accrued expenses and other current
liabilities 1,198 1,258
Current maturities of long-term debt 140 105
Current portion of capital lease
obligation 43 43
Deferred income 724 765
------------ -----------
Total Current Liabilities 7,293 8,309
Long-term debt, net of current
maturities 5,683 5,560
Capital lease obligation 48 48
Termination indemnities 682 696
------------ -----------
Total Liabilities 13,706 14,613
------------ -----------
Share capital (par value: EUR 1.00;
15,100,292 and 17,454,292 shares
authorized; 11,773,613 and 14,191,294
shares issued at December 31, 2006 and
March 31 2007, respectively) 11,774 14,191
Additional paid in capital 49,476 82,332
Other comprehensive income 32 (1)
Accumulated deficit (39,595) (44,368)
------------ -----------
Total Shareholders' Equity 21,687 52,154
------------ -----------
Total Liabilities and Shareholders'
Equity EUR 35,393 EUR 66,767
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GENTIUM S.p.A.
Statements of Operations
(Unaudited, amounts in thousands except share and per share data)
Three Months Ended
March 31,
----------------------------
2006 2007
---------- -----------
Revenues:
Sales to affiliates EUR 912 EUR 951
Third party product sales 3 267
---------- -----------
Total product sales 915 1,218
Other income and revenues 35 35
---------- -----------
Total Revenues 950 1,253
Operating costs and expenses:
Cost of goods sold 711 754
Charges from affiliates 215 226
Research and development 1,675 3,075
General and administrative 1,296 1,291
Depreciation and amortization 42 75
---------- -----------
(3,939) (5,421)
---------- -----------
Operating loss (2,989) (4,168)
Foreign currency exchange gain (loss),
net (168) (868)
Interest income, net 52 263
---------- -----------
Net loss EUR (3,105) EUR (4,773)
---------- -----------
Net loss per share:
Basic and diluted net loss per share EUR (0.32) EUR (0.36)
========== ===========
Weighted average shares used to compute
basic and diluted net loss per share 9,610,630 13,117,049
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GENTIUM S.p.A.
Statements of Cash Flows
(Unaudited, amounts in thousands)
Three Months Ended
March 31,
-----------------------
2006 2007
------- -------
Cash Flows From Operating Activities:
Net loss EUR (3,105) EUR (4,773)
------- -------
Adjustments to reconcile net income to net
cash used in operating activities:
Unrealized foreign exchange loss 140 815
Depreciation and amortization 219 278
Non cash share based compensation 213 241
Deferred income (35) (35)
Changes in operating assets and liabilities:
Accounts receivable (131) (897)
Inventories (152) (347)
Prepaid expenses and other current and non
current assets 188 109
Accounts payable, accrued expenses and
other long term liabilities 639 1,033
------- -------
Net cash used in operating activities (2,024) (3,575)
------- -------
Cash Flows From Investing Activities
Capital expenditures (198) (228)
Intangible expenditures (274) (120)
------- -------
Net cash used in investing activities (472) (348)
------- -------
Cash Flows From Financing Activities:
Repayments of long-term debt (401) (82)
Proceeds from warrant and stock option
exercise exercises - 549
Proceeds from private placement, net - 34,485
------- -------
Net cash provided by/(used in) financing
activities (401) 34,952
------- -------
Increase/(decrease) in cash and cash
equivalents (2,897) 31,029
Effect of exchange rate on cash and cash
equivalents (142) (827)
Cash and cash equivalents, beginning of period 12,785 10,205
------- -------
Cash and cash equivalents, end of period EUR 9,746 40,407
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