UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November, 2011.

Commission File Number 000-51341
 
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)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x  Form 40-F ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o

Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant’s “home country”), or under the rules of the home country exchange on which the registrant’s securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant’s security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934. Yes ¨  No x

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):
82-_______________.

 
 

 

The Registrant's press release regarding its financial results for the period ended September 30, 2011 is attached hereto as Exhibit 1 and incorporated by reference herein in its entirety.  This report and the exhibit attached thereto are incorporated by reference into the registration statements of Gentium S.p.A. on Forms F-3:  File No. 333-135622, File No. 333-137551, File No. 333-138202, File No. 333-139422, File No. 333-141198, and File No. 333-174575, and on Forms S-8: File No. 333-137534 and File No. 333-146534.
 
Exhibit
 
Description
     
1
  
Press release dated November 15, 2011.

 
 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 
GENTIUM S.P.A.
       
 
By:
/s/ Salvatore Calabrese
   
Name: 
Salvatore Calabrese
   
Title:
Chief Financial Officer and Senior VP, Finance

Date: November 15, 2011.

 
 

 

INDEX TO EXHIBITS

Exhibit
 
Description
     
1
  
Press release dated November 15, 2011.

 
 

 
 


Exhibit 1

PRESS RELEASE


Gentium Reports Third Quarter 2011 Financial Results
 
 
·
Defibrotide product sales increased by 24%
 
 
·
Product sales of EUR 16.02 million for the nine-months ended September 30, 2011
 
 
·
Cash flow positive
 
 
·
On target with revised projected product sales guidance of EUR 21-23 million for 2011
 
VILLA GUARDIA (COMO), Italy, November 15, 2011 (GlobeNewswire) — Gentium S.p.A. (NASDAQ: GENT) (the “Company”) today reported financial results for the nine-month period and quarter ended September 30, 2011.  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 September 30, 2011, EUR 1.00 = $1.3503.
 
“We are pleased to report that Defibrotide product sales increased 24% to EUR 12.33 million when compared to EUR 9.97 million for the prior-year nine-month period and that we continue to be cash flow positive,” stated Salvatore Calabrese, Senior Vice President and Chief Financial Officer of Gentium S.p.A. “The comparative quarterly results have been affected mainly by non-cash items such as the termination in revenue recognition for an up-front payment made by Sigma-Tau in 2010, as well as restructuring charges and sales and marketing expenses which were not present in the prior year’s quarter.  We expect to meet our revised product sales guidance of EUR 21-23 million for 2011.”
 
“We continue to see an increase in the number of clinics using Defibrotide to treat and prevent veno-occlusive disease (VOD),” stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A.  “We credit this in part to the contribution of our specialized regional partners who distribute Defibrotide on a named-patient basis in local regions, simplifying access for clinics.  We are exploring opportunities to expand into new territories, as well as increase our visibility in those geographic areas in which we are already present.  On the regulatory front, we have engaged an independent clinical research organization who is reviewing and identifying issues related to the datasets previously submitted to the US Food and Drug Administration. In the meantime, we have received and reviewed the Day 120 List of Questions from the European Medicines Agency and anticipate that we will submit our responses by year end.”
 
Financial Highlights
 
For the nine-month period ended September 30, 2011 compared to the same period in 2010:
 
 
·
Defibrotide net-sales increased 24% to EUR 12.33 million, or 77% of total product sales, compared to EUR 9.97 million, or 67% of total product sales.  Sales of the company’s active pharmaceutical ingredients (API) amounted to EUR 3.69 million, or 23% of total product sales, compared to EUR 4.91 million or a 25% decrease. Total product sales increased 8% to EUR 16.02 million compared to EUR 14.87 million.
 
 
·
Total revenues were EUR 18.04 million compared to EUR 18.44 million.

 
1

 
 
 
·
Operating costs and expenses were EUR 14.99 million compared to EUR 14.83 million. 2011 and 2010 operating costs and expenses include restructuring charges of EUR 0.34 million and EUR 0.95 million, respectively.
 
 
·
Research and development expenses, which are included in operating costs and expenses, were EUR 4.00 million compared to EUR 4.63 million.
 
 
·
Sales and marketing expenses, which are included in operating costs and expenses, were EUR 1.34 million compared to none.
 
 
·
Operating income was EUR 3.06 million compared to EUR 3.62 million.
 
 
·
Income tax expenses were EUR 0.37 million compared to EUR 0.22.
 
 
·
Net income was EUR 2.63 million compared to EUR 3.44 million.
 
 
·
Basic and diluted net income per share was EUR 0.176 and EUR 0.167, respectively, compared to EUR 0.230 per share.
 
For the third quarter ended September 30, 2011 compared to the third quarter of 2010:
 
 
·
Defibrotide net sales increased 22% to EUR 4.10 million, or 78% of total product sales, compared to EUR 3.36 million, or 69% of the total product sales. Sales of the company’s API amounted to EUR 1.13 million, or 22% of total product sales, compared to EUR 1.49 million or a 24% decrease. Total product sales increased 8% to EUR 5.23 million compared to EUR 4.85 million.
 
 
·
Total revenues were EUR 5.27 million compared to EUR 5.91 million.
 
 
·
Operating costs and expenses were EUR 5.30 million compared to EUR 4.36 million.  2011 operating costs and expenses include restructuring charges of EUR 0.34 million.
 
 
·
Research and development expenses, which are included in operating costs and expenses, were EUR 1.34 million compared to EUR 1.17 million.
 
 
·
Sales and marketing expenses, which are included in operating costs and expenses, were EUR 0.57 million compared to none.
 
 
·
Operating income/(loss) was EUR (0.03) million compared to EUR 1.55 million.
 
 
·
Net income/(loss) was EUR (0.04) million compared to EUR 1.12 million.
 
 
·
Basic and diluted net income/(loss) per share was EUR (0.003) compared to EUR 0.075 per share.
 
Cash and cash equivalents were EUR 9.91 million as of September 30, 2011 compared to EUR 8.74 million as of December 31, 2010.
 
Operating Results
 
Product sales for the nine-month period ended September 30, 2011 were EUR 16.02 million compared to EUR 14.87 million for the same period in 2010, an increase of EUR 1.15 million or 8%.  The increase was primarily due to the increased distribution of Defibrotide through the named-patient and cost recovery programs.

For the nine-month periods ended September 30, 2011 and 2010, sales from the named-patient and cost recovery programs amounted to EUR 12.33 million and EUR 9.97 million, respectively, representing an increase of EUR 2.36 million or 24%. Sales from the named-patient and cost recovery programs are net of EUR 2.29 million and EUR 1.59 million, respectively, in service fees.

 
2

 

API revenues were EUR 3.69 million for the nine-month period ended September 30, 2011, compared to EUR 4.91 million for the same period in 2010, reflecting a decrease of EUR 1.22 million or 25%. The decrease was primarily due to lower sales and a reduction in the price and volume of sulglicotide to accommodate a commercial partner in South Korea that has experienced a 20% cut in reimbursement from its local government for its finished drug product that uses sulglicotide as the API.
 
Other revenues were EUR 2.02 million for the nine-month period ended September 30, 2011 compared to EUR 3.57 million for the same period in 2010. This fluctuation is primarily attributable to a decrease in pre-clinical and clinical trial activities that were eligible for reimbursement from Sigma-Tau under a cost sharing arrangement with the Company, which amounted to EUR 0.29 million and EUR 0.86 million for the nine months ended September 30, 2011 and 2010, respectively.  In addition, the fluctuation is attributable to the ratable recognition of EUR 1.70 million ($2.23 million) and EUR 2.56 million ($3.50 million) for the nine months ended September 30, 2011 and 2010 of the EUR 5.11 million ($7.0 million) up-front payment made by Sigma-Tau in connection with the amendment of the existing license and supply agreement with the Company to include the prevention indication of Defibrotide in the Americas. The up-front payment was recognized ratably, commencing in January 2010 through the second quarter of 2011.
 
Cost of goods sold was EUR 4.15 million for the nine-month period ended September 30, 2011 compared to EUR 4.29 million for the same period in 2010.  Cost of goods sold as a percentage of product sales was 26% for the nine-month period ended September 30, 2011 compared to 29% for the same period in 2010. The percentage decrease is primarily due to a different product mix with proportionately increased sales of Defibrotide, which has a higher margin compared to sales of the Company’s other active pharmaceutical ingredients.

The Company incurred research and development expenses of EUR 4.00 million for the nine-month period ended September 30, 2011 compared to EUR 4.63 million for the same period in 2010. Research and development expenses were primarily for the development of Defibrotide to treat and prevent VOD. The decrease from the comparable period in 2010 is attributed to the completion of certain pre-clinical and clinical trials, such as reproductive toxicity, hERG channel, QT/QTc and completion of a technology transfer to a third party, offset by an increase in scientific consultancy and regulatory activities.

General and administrative expenses were EUR 4.34 million for the nine-month period ended September 30, 2011 compared to EUR 4.07 million for the same period in 2010.  2010 general and administrative expenses include a release of a reserve for doubtful accounts for EUR 0.27 million due to the deemed payment of accounts receivable through the elimination of the same amount of accounts payable due to the same counterparty.  The slight increase in general and administrative expenses was primarily due to administrative expenses incurred with the incorporation of a subsidiary in Switzerland along with higher stock-based compensation expenses which amounted to EUR 1.07 million and EUR 0.85 million for the nine months ended September 30, 2011 and 2010, respectively, offset by a decrease in administrative and payroll expenses previously incurred by the Company’s New York office, which closed in 2010.

Sales and marketing expenses were EUR 1.34 million for the nine-month period ended September 30, 2011 compared to none for the same period in 2010. Sales and marketing expenses mainly refer to expenses relating to recruiting, payroll, marketing and health economics analysis, and stock-based compensation expenses.

 
3

 

Corporate restructuring charges were EUR 0.34 million and EUR 0.95 million for the nine-month periods ended September 30, 2011 and 2010 respectively.

Income tax expenses were EUR 0.37 million and EUR 0.22 million for the nine-month periods ended September 30, 2011 and 2010, respectively. Income tax expenses  include a provision for the Italian Regional Tax on Productive Activities, or “IRAP,” which has a statutory rate of 3.9%. The IRAP tax is not deductible for corporate purposes. The IRAP tax base is similar to the corporate tax base, but does not permit a deduction for labor and interest.

Net income was EUR 2.63 million for the nine-month period ended September 30, 2011 compared to EUR 3.44 million for the same period in 2010. The difference is mainly due to an increase in the volume of Defibrotide sold through the named-patient and cost recovery programs.  The increase in Defibrotide sales has offset the decrease in the Company’s active pharmaceutical ingredient sales, the decrease in activities that were eligible for reimbursement from Sigma-Tau under a cost sharing arrangement with the Company, costs associated with the establishment of our European sales infrastructure, which was not present in 2010. 2011 and 2010 financial results were also affected by restructuring charges of EUR 0.34 million and EUR 0.95 million, respectively.
 
About VOD
 
Veno-occlusive disease (VOD) is a potentially life-threatening condition, which typically occurs as a result of a significant complication of stem cell transplantation. Certain high-dose conditioning regimens used as part of stem cell transplants (SCT) can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins of the liver that leads to liver failure and can result in significant dysfunction of other organs such as the kidneys and lungs (so-called severe VOD). SCT is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children. There is currently no approved agent for the treatment or prevention of VOD in the United States or the European Union.
 
About Gentium
 
Gentium S.p.A., located in Como, Italy, is a biopharmaceutical company focused on the development and manufacture of drugs to treat and prevent a variety of diseases and conditions, including vascular diseases related to cancer and cancer treatments. Defibrotide, the Company's lead product candidate, is an investigational drug that has been granted Orphan Drug status by the U.S. FDA and Orphan Medicinal Product Designation by the European Commission both to treat and to prevent VOD and Fast Track Designation by the U.S. FDA to treat 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, including with respect to any financial forecast or the possibility of any future regulatory approval, may differ 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 the Company’s Form 20-F filed with the Securities and Exchange Commission under the caption "Risk Factors."

 
4

 

GENTIUM S.p.A.
Consolidated Balance Sheets
(Amounts in thousands, except share and per share data)

   
As of 
December 31,
   
As of 
September 30,
 
   
2010
   
2011
 
         
(unaudited)
 
ASSETS
           
Cash and cash equivalents
  8,742     9,907  
Available for sale securities
    263       -  
Accounts receivable net of allowance of €27 as of December 31, 2010 and September 30, 2011
    3,442       4,771  
Accounts receivable from related parties, net of allowance of €850 as of December 31, 2010 and September 30, 2011
    657       204  
Inventories, net of allowance of €451 and €366 as of December 31, 2010 and September 30, 2011, respectively
    2,364       3,173  
Prepaid expenses and other current assets
    541       572  
Total Current Assets
    16,009       18,627  
                 
Property, manufacturing facility and equipment, at cost
    21,437       22,662  
Less:  Accumulated depreciation
    12,839       13,806  
Property, manufacturing facility and equipment, net
    8,598       8,856  
                 
Intangible assets, net of amortization
    54       47  
Other non-current assets
    13       24  
Total Assets
  24,674     27,554  
                 
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
Accounts payable
  4,308     5,095  
Accounts payable to related parties
    372       188  
Accrued expenses and other current liabilities
    1,902       2,189  
Deferred Revenues
    1,704       401  
Current portion of capital lease obligations
    70       39  
Current maturities of long-term debt
    1,098       524  
Total Current Liabilities
    9,454       8,436  
                 
Long-term debt, net of current maturities
    1,759       1,722  
Capital lease obligations
    21       -  
Termination indemnities
    510       424  
Total Liabilities
    11,744       10,582  
                 
Share capital (no par value; 18,302,617 and 19,656,317 shares authorized as of December 31, 2010 and September 30, 2011; 14,956,317 and 14,969,150 shares issued and outstanding at December 31, 2010 and September 30, 2011, respectively)
    108,485       109,895  
Accumulated deficit
    (95,555 )     (92,923 )
Total Shareholders’ Equity
    12,930       16,972  
Total Liabilities and Shareholders’ Equity
  24,674     27,554  

 
5

 

GENTIUM S.p.A.
Consolidated Statements of Income
(Unaudited, amounts in thousands of Euro except share and per share data)

   
Three months ended
September 30
   
Nine months ended
September 30,
 
   
2010
   
2011
   
2010
   
2011
 
Revenues:
                       
API product sales
  1,489     1,128     4,909     3,692  
NPP product sales
    3,361       4,098       9,961       12,330  
Total product sales
    4,850       5,226       14,870       16,022  
Other revenues
    112       6       150       24  
Other revenues from related party
    946       41       3,422       1,997  
Total revenues
    5,908       5,273       18,442       18,043  
                                 
Operating costs and expenses:
                               
Cost of goods sold
    1,420       1,395       4,285       4,147  
Research and development
    1,174       1,337       4,625       3,996  
General and administrative
    1,468       1,369       4,074       4,341  
Sales and Marketing
    -       566       -       1,344  
Charges from related parties
    69       51       218       177  
Restructuring charges
    -       344       953       344  
Depreciation and amortization
    224       239       671       639  
      4,355       5,301       14,826       14,988  
Operating income/(loss)
    1,553       (28 )     3,616       3,055  
                                 
Foreign currency exchange gain/(loss), net
    (191 )     53       104       (10 )
Interest income/(expense), net
    (23 )     10       (64 )     (48 )
Income before income tax expense
    1,339       35       3,656       2,997  
                                 
Provision for income taxes:
                               
Income tax expense
    (216 )     (77 )     (216 )     (365 )
Net income/(loss)
  1,123     (42 )   3,440     2,632  
                                 
Shares used in calculation of earnings per share
                               
Basic
    14,956,317       14,968,333       14,956,317       14,962,286  
Diluted
    14,956,317       14,968,333       14,956,317       15,793,186  
                                 
Earnings per share:
                               
Basic
    0.075       (0.003 )     0.230       0.176  
Diluted
    0.075       (0.003 )     0.230       0.167  

 
6

 

GENTIUM S.p.A.
Consolidated Statements of Cash Flows
(Unaudited, amounts in thousands of Euro)

   
For the Nine Months
Ended September 30,
 
   
2010
   
2011
 
Cash Flows From Operating Activities:
           
Net income
  3,440     2,632  
Adjustments to reconcile net income to net cash provided by operating activities:
    -          
Inventory allowance/(release of allowance)
    143       (85 )
Unrealized foreign exchange gain
    (32 )     (16 )
Depreciation and amortization
    983       978  
Stock based compensation
    1,179       1,334  
Loss on fixed asset disposal
    20       -  
Release of allowance for doubtful accounts
    (250 )     -  
Deferred revenues
    2,556       (1,303 )
Provision for income tax
    216       509  
Changes in operating assets and liabilities:
               
Accounts receivable
    (482 )     (823 )
Inventories
    (358 )     (724 )
Prepaid expenses and other current and noncurrent assets
    769       (42 )
Accounts payable and accrued expenses
    102       (344 )
Termination indemnities
    (94 )     (86 )
Net cash provided by operating activities
    8,192       2,030  
                 
Cash Flows From Investing Activities
               
Purchase of equipments and furniture
    (84 )     (512 )
Proceeds from sales of marketable securities
    -       263  
Net cash used in investing activities
    (84 )     (249 )
                 
Cash Flows From Financing Activities:
               
Repayment of long-term debt
    (188 )     (611 )
Principal payment of capital lease obligations
    (50 )     (51 )
Proceeds from stock option exercise
    -       77  
Net cash used in financing activities
    (238 )     (585 )
                 
Increase in cash and cash equivalents
    7,870       1,196  
Effect of exchange rate on cash and cash equivalents
    28       (29 )
Cash and cash equivalents, beginning of period
    1,392       8,742  
Cash and cash equivalents, end of period
  9,290     9,909  

 
7

 
 
SOURCE: Gentium S.p.A.

Gentium S.p.A.
Salvatore Calabrese, +39 031-385-287
SVP & CFO
scalabrese@gentium.it

or

The Trout Group
Christine Labaree, +1 646-378-2951
clabaree@troutgroup.com

 
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