|
Gentium
S.p.A.
|
|
(Translation
of registrant’s name into
English)
|
|
Piazza
XX Settembre 2, 22079 Villa Guardia
(Como), Italy
|
|
(Address
of principal executive
office)
|
| Exhibit | Description | |
| 1 | Press release, dated April 1, 2008. |
| Exhibit | Description | |
| 1 | Press release, dated April 1, 2008. |
| PRESS RELEASE |
| · |
Continued
progress was made in the ongoing Phase III clinical trial in the
U.S.,
which is evaluating the Company's lead product, Defibrotide, as a
potential treatment for patients with Veno-Occlusive Disease ("VOD")
with
multiple organ failure ("Severe VOD"). This trial has now enrolled
85
patients to date in its prospective arm and 86 patients in the historical
control arm. The DSMB initiated its interim analysis in January 2008
and
concluded that there are no safety concerns and that stratification
between the prospective treatment and historical control arms appears
to
be balanced. The DSMB requested that certain trial data be clarified
and
supplemented. Once the DSMB has concluded its review, the Company
plans to
make a further announcement.
|
| · |
In
December 2007, the Company filed an amendment to the protocol for
its
Phase III clinical trial of Defibrotide to treat Severe VOD. The
trial
previously had a primary endpoint of survival at 100 days after stem
cell
transplantation, and a secondary endpoint of complete response. The
amendment reversed those endpoints, making complete response the
primary
endpoint and survival a major secondary endpoint. The Company has
already
been collecting data on both endpoints, and therefore the change
will not
delay or require additional enrollment of patients. Complete response
was
the primary endpoint for the Phase II clinical trial of Defibrotide
to
treat Severe VOD that was completed in 2005. The Company made this
change
after discussions with the FDA and believes that complete response
better
demonstrates the efficacy of Defibrotide and therefore is a more
appropriate endpoint for this
trial.
|
| · |
In
Q4 2007, the Company instituted an expanded access program for Defibrotide
to treat Severe VOD. Under an expanded access program, the FDA allows
early access to investigational drugs that are being developed to
treat
serious diseases for which there is no satisfactory alternative therapy.
The Company will collect additional safety data from the expanded
access
program patients to support its planned New Drug Application for
the use
of Defibrotide to treat Severe VOD.
|
| · |
Progress
has also been made with the Company's Phase II/III clinical trial
in
Europe, which is evaluating Defibrotide for the prevention of VOD
in
children. The trial has enrolled 251 of an expected 270 patients
and the
interim analysis is anticipated to begin during
2008.
|
| · |
The
Company has recently received a scientific advice letter from the
European
Medicine’s Agency (EMEA) regarding the protocol of ongoing and future
trials for Defibrotide in the prevention of VOD in adult and pediatric
patients. The process of obtaining a scientific advice letter allows
companies to establish a dialogue with the EMEA and receive advice
regarding the trials and data necessary to demonstrate the quality,
safety
and efficacy of drugs in development. Scientific advice received
from the
EMEA is applicable across the European Union.
|
| · |
In
October 2007, in connection with its current License and Supply Agreement
with Sigma-Tau Pharmaceuticals, Inc., the Company signed a letter
agreement with Sigma-Tau whereby Sigma-Tau agreed to reimburse the
Company
for 50% of certain costs of the Company's Phase III clinical trial
of
Defibrotide to treat Severe VOD.
|
| · |
In
October 2007, the Company exercised a right to require the exercise
of
warrants issued in connection with its 2005 PIPE offering. The Company
realized gross proceeds of approximately $5.384 million from these
exercises, bringing cash and cash equivalents to €25.96 million at year
end.
|
| · |
Investigators
from the European Phase I/II clinical trial of Defibrotide to treat
advanced and refractory multiple myeloma patients presented the final
results at the American Society of Hematology Annual Meeting in December
2007.
|
| · |
Investigators
are presenting abstracts and publications featuring Defibrotide at
the
European Group Bone and Marrow Transplantation (EBMT) Annual Congress,
taking place in Florence, Italy from March 30 through April 2, 2008.
|
| · |
Total
revenues were €2.23 million, compared with €1.32
million
|
| · |
Operating
costs and expenses were €7.84 million, compared with €5.14
million
|
| · |
Research
and development expenses, which are included in operating costs and
expenses, were €4.36 million, compared with €2.56
million
|
| · |
Operating
loss was €5.61 million, compared with €3.82
million
|
| · |
Interest
income, net, was €0.4 million, compared with €0.2
million
|
| · |
Pre-tax
loss was €6.25 million, compared with €4.15
million
|
| · |
Net
loss was €6.25 million, compared with €4.15
million
|
| · |
Basic
and diluted net loss per share was €0.42 compared with €0.35 per
share
|
| · |
Total
revenues were €7.61 million, compared with €4.32
million
|
| · |
Operating
costs and expenses were €40.58 million, compared with €18.55 million.
Operating costs and expenses include a €13.74 million write-down of the
assets the Company acquired from Crinos in 2007. Excluding such
write-down, operating costs and expenses would have been €26.84
million.
|
| · |
Research
and development expenses, which are included in operating costs and
expenses, were €15.09 million, compared with €8.93
million
|
| · |
Operating
loss was €32.96 million, compared with €14.23 million. Excluding the
write-down of the assets acquired from Crinos, operating loss would
have
been €19.22 million.
|
| · |
Interest
income, net, was €1.36 million, compared with €0.49
million
|
| · |
Pre-tax
loss was €35.60 million, compared with €14.37 million
|
| · |
Net
loss was €35.60 million, compared with €14.37 million. Excluding the
write-down of the assets acquired from Crinos, net loss would have
been
€21.86 million.
|
| · |
Basic
and diluted net loss per share was €2.52 compared with €1.33 per
share. Excluding
the write-down of the assets acquired from Crinos, basic and diluted
net
loss per share would have been €1.55 per
share.
|
| · |
Cash
used in operating activities was €10.17 million, compared with €12.15
million
|
| · |
Cash
and cash equivalents amounted to €25.96 million as of December 31,
2007
|
|
As
of December 31,
|
|||||||
|
2006
|
2007
|
||||||
|
ASSETS
|
|||||||
|
Cash
and cash equivalents
|
€ |
10,205
|
€
|
25,964
|
|||
|
Restricted
cash
|
4,000
|
-
|
|||||
|
Accounts
receivables
|
227
|
805
|
|||||
|
Accounts
receivables from related parties
|
3,478
|
4,149
|
|||||
|
Inventories,
net
|
1,499
|
1,510
|
|||||
|
Prepaid
expenses and other current assets
|
1,427
|
4,844
|
|||||
|
Total
Current Assets
|
20,836
|
37,272
|
|||||
|
Property,
manufacturing facility and equipment, at cost
|
18,974
|
20,590
|
|||||
|
Less:
Accumulated depreciation
|
9,550
|
9,046
|
|||||
|
Property,
manufacturing facility and equipment, net
|
9,424
|
11,544
|
|||||
|
Intangible
assets, net of amortization
|
556
|
2,592
|
|||||
|
Marketable
securities
|
560
|
525
|
|||||
|
Other
non-current assets
|
4,017
|
26
|
|||||
|
Total
Assets
|
€ |
35,393
|
€ |
51,959
|
|||
|
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
|
Accounts
payable
|
€ |
4,734
|
€ |
9,583
|
|||
|
Accounts
payable to Crinos
|
-
|
4,000
|
|||||
|
Accounts
payable to related parties
|
454
|
2,095
|
|||||
|
Accrued
expenses and other current liabilities
|
1,198
|
1,223
|
|||||
|
Deferred
revenue
|
140
|
-
|
|||||
|
Current
portion of capital lease obligation
|
43
|
107
|
|||||
|
Current
maturities of long-term debt
|
724
|
1,262
|
|||||
|
Total
Current Liabilities
|
7,293
|
18,270
|
|||||
|
Long-term
debt, net of current maturities
|
5,683
|
4,421
|
|||||
|
Capital
lease obligation
|
48
|
223
|
|||||
|
Termination
indemnities
|
682
|
686
|
|||||
|
Total
Liabilities
|
13,706
|
23,600
|
|||||
|
Share
capital (par value: €1.00; 15,111,292 and 18,454,292 shares authorized at
December 31, 2006 and 2007, respectively; 11,773,613 and 14,946,317
shares
issued at December 31, 2006 and 2007, respectively)
|
11,774
|
14,946
|
|||||
|
Additional
paid in capital
|
49,476
|
88,618
|
|||||
|
Accumulated
other comprehensive income (loss)
|
32
|
(2
|
)
|
||||
|
Accumulated
deficit
|
(39,595
|
)
|
(75,203
|
)
|
|||
|
Total
Shareholders’ Equity
|
21,687
|
28,359
|
|||||
|
Total
Liabilities and Shareholders’ Equity
|
€ |
35,393
|
€ |
51,959
|
|||
|
For
the Three Months Ended
December
31,
|
For
the Year Ended
December
31,
|
||||||||||||
|
2006
|
2007
|
2006
|
2007
|
||||||||||
|
Revenues:
|
|
|
|
||||||||||
|
Product
sales to related party
|
€ |
1,102
|
€ |
557
|
€ |
3,754
|
€ |
2,704
|
|||||
|
Product
sales to third party
|
166
|
1,062
|
321
|
2,390
|
|||||||||
|
Total
product sales
|
1,268
|
1,619
|
4,075
|
5,094
|
|||||||||
|
Other
revenues
|
52
|
611
|
249
|
2,515
|
|||||||||
|
Total
Revenues
|
1,320
|
2,230
|
4,324
|
7,609
|
|||||||||
|
|
|||||||||||||
|
Operating
costs and expenses:
|
|||||||||||||
|
Cost
of goods sold
|
648
|
1,300
|
3,092
|
3,983
|
|||||||||
|
Research
and development
|
2,565
|
4,364
|
8,927
|
15,098
|
|||||||||
|
General
and administrative
|
1,634
|
1,696
|
5,421
|
6,279
|
|||||||||
|
Depreciation
and amortization
|
71
|
222
|
261
|
725
|
|||||||||
|
Charges
from related parties
|
222
|
258
|
854
|
748
|
|||||||||
|
Write-down
of acquired assets
|
-
|
-
|
-
|
13,740
|
|||||||||
|
|
5,140
|
7,840
|
18,555
|
40,573
|
|||||||||
|
Operating
loss
|
(3,820
|
)
|
(5,610
|
)
|
(14,231
|
)
|
(32,964
|
)
|
|||||
|
|
|||||||||||||
|
Foreign
currency exchange gain
(loss), net
|
(483
|
)
|
(991
|
)
|
(627
|
)
|
(4,001
|
)
|
|||||
|
Interest
income
(expense), net
|
152
|
348
|
490
|
1,357
|
|||||||||
|
|
|||||||||||||
|
Loss
before income tax expenses
|
(4,151
|
)
|
(6,253
|
)
|
(14,368
|
)
|
(35,608
|
)
|
|||||
|
Income
tax
expense
|
-
|
-
|
-
|
-
|
|||||||||
|
Net
loss
|
€ |
(4,151
|
)
|
€ |
(6,253
|
)
|
€ |
(14,368
|
)
|
€ |
(35,608
|
)
|
|
|
|
|||||||||||||
|
Shares
used in computing net loss per share, basic
and
diluted
|
11,704,661
|
€ |
14,793,129
|
€ |
10,808,890
|
€ |
14,105,128
|
||||||
|
Net
loss per share:
|
|||||||||||||
|
Basic
and
diluted net loss per
share
|
€ |
(0.35
|
)
|
(0.42
|
)
|
(1.33
|
)
|
(2.52
|
)
|
||||
|
For
the Year Ended December 31,
|
|||||||
|
2006
|
2007
|
||||||
|
Cash
Flows From Operating Activities:
|
|||||||
|
Net
loss
|
€ |
(14,368
|
)
|
€ |
(35,608
|
)
|
|
|
Adjustments
to reconcile net income to net cash provided by (used in) operating
activities:
|
|||||||
|
Write-down
of acquired assets
|
-
|
13,740
|
|||||
|
Unrealized
foreign exchange loss
|
509
|
2,951
|
|||||
|
Depreciation
and amortization
|
1,008
|
1,538
|
|||||
|
Stock
based compensation
|
908
|
1,804
|
|||||
|
Deferred
revenue
|
(143
|
)
|
(140
|
)
|
|||
|
Gain
on fixed assets disposal
|
(23
|
)
|
(15
|
)
|
|||
|
Adjustment
of inventory to net realizable value
|
-
|
206
|
|||||
|
Non
cash interest expense
|
4
|
-
|
|||||
|
Changes
in operating assets and liabilities:
|
|||||||
|
Accounts
receivable
|
(1,830
|
)
|
(1,249
|
)
|
|||
|
Inventories
|
129
|
(217
|
)
|
||||
|
Prepaid
expenses, other current and non current assets
|
(482
|
)
|
(3,426
|
)
|
|||
|
Accounts
payable and accrued expenses
|
2,165
|
10,243
|
|||||
|
Termination
indemnities
|
(24
|
)
|
4
|
||||
|
Net
cash used in operating activities
|
(12,147
|
)
|
(10,169
|
)
|
|||
|
Cash
Flows From Investing Activities
|
|||||||
|
Capital
expenditures
|
(1,445
|
)
|
(2,890
|
)
|
|||
|
Intangible
expenditures
|
(503
|
)
|
(215
|
)
|
|||
|
Proceeds
from sale of asset
|
23
|
15
|
|||||
|
Restricted
Cash
|
(4,000
|
)
|
4,000
|
||||
|
Acquisition
of Crinos Assets
|
(4,000
|
)
|
(12,000
|
)
|
|||
|
Investment
in marketable securities
|
(530
|
)
|
-
|
||||
|
Net
cash used in investing activities
|
(10,455
|
)
|
(11,090
|
)
|
|||
|
Cash
Flows From Financing Activities:
|
|||||||
|
Proceeds
from equity offering, net
|
15,896
|
34,483
|
|||||
|
Proceeds
from warrant and stock option exercise exercises
|
1,736
|
6,027
|
|||||
|
Repayments
of long-term debt
|
(681
|
)
|
(724
|
)
|
|||
|
Proceeds
from short term borrowings
|
-
|
279
|
|||||
|
Principal
payment of capital lease obligations
|
(42
|
)
|
(89
|
)
|
|||
|
Proceeds
from long term debt, net
|
5,518
|
-
|
|||||
|
Early
extinguishment of long term debt
|
(1,868
|
)
|
-
|
||||
|
Net
cash provided by financing activities
|
20,559
|
39,976
|
|||||
|
Effect
of foreign exchange rate
|
(537
|
)
|
(2,958
|
)
|
|||
|
Increase/(decrease)
in cash and cash equivalents
|
(2,043
|
)
|
18,717
|
||||
|
Cash
and cash equivalents, beginning of period
|
12,785
|
10,205
|
|||||
|
Cash
and cash equivalents, end of period
|
€ |
10,205
|
€ |
25,964
|
|||
| GENTIUM S.P.A. | ||
| |
|
|
| By: | /s/ Gary G. Gemignani | |
|
Name: Gary G. Gemignani |
||
| Title: Executive Vice President and Chief Financial Officer | ||