The Board of Directors of MolMed S.p.A., chaired by Prof. Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The most important elements were: TK: expansion in the US of the pivotal Phase III trial for high-risk leukaemia patients; NGR-TNF: continuation of the clinical development program; the increase of revenues to € 3.1 million from development of new cell and gene therapy treatments for third parties.
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MolMed Approved The Interim Financial Report At 30 September 2013
1. PRESS RELEASE
MolMed Board of Directors approves the interim financial report
at 30 September 2013
Milan (Italy), 11 November 2013 – The Board of Directors of MolMed S.p.A. (MLM.MI), chaired by Prof.
Claudio Bordignon, today reviewed and approved the interim financial report at 30 September 2013. The
most important elements were:
TK: expansion in the US of the pivotal Phase III trial (TK008) for high-risk leukaemia patients;
NGR-hTNF: continuation of the clinical development program, in particular with the achievement of
new statistically significant results on the increase in overall survival of patients treated weekly with
low doses NGR-hTNF in combination with doxorubicin in the randomised Phase II study in soft
tissues sarcomas;
The increase of revenues to € 3.1 million (+11.9% compared to the first 9 months 2012) from
development of new cell and gene therapy treatments for third parties.
Claudio Bordignon, Chairman of the Board and CEO of MolMed, commented: "Consistently with the first half
of 2013, the last quarter was characterized by important confirmation on the potential of both our
investigational antitumoral therapeutics: TK and NGR-hTNF. As far as TK is concerned, the expansion of the
Phase III clinical study in the United States opens a new important frontier for the company, with an
important sign of interest by prestigious American clinical centers participating in the study.
With regard to NGR- hTNF, the analysis of the randomized Phase II trial of NGR -hTNF in soft tissue
sarcomas showed - in addition to what was already observed last year in terms of progression-free survival a statistically significant increase in overall survival for those patients included in the arm treated with the 0.8
μg/sqm dose of NGR-hTNF administered weekly in combination with doxorubicin. These results confirm the
previously observed effectiveness of NGR-hTNF in various cancer indications and validate the choice of the
low doses administered weekly utilized in the treatment of malignant pleural mesothelioma currently in
Phase III, with results expected between December 2013 and January 2014.
The activities in development and production of cell and gene therapies confirmed the leadership of the
Company is playing at an international level is confirmed by the results obtained in this field and by the
constant increase in revenues”.
Highlights of financial data
Key income statements
rd
(amounts in € thousand) 3 quarter
3
rd
quarter
1/1/2013 -
1/1/2012 -
30/9/2013(a) 30/9/2012(b)
Variation
2013
2012
(a-b)
%
OPERATING REVENUES
685
639
3,409
3,062
347
11.3
REVENUES FROM ACTIVITIES FOR THIRD PARTIES
613
567
3,101
2,770
331
11.9
OPERATING COSTS
5,119
6,600
17,894
20,076
(2,182)
(10.9)
OPERATING RESULT
(4,434)
(5,961)
(14,485)
(17,014)
2,529
14.9
FROM GENES TO THERAPY
MOLMED S.p.A.
Via Olgettina, 58 - 20132 Milan, Italy | Phone +39 02 21277.1 - Fax +39 02 21277.325
info@molmed.com - www.molmed.com
Share capital € 27,070,992.30 fully paid - Office of Milan Company Registry number 1506630 - Tax identification number 11887610159
1
2. PRESS RELEASE
NET FINANCIAL INCOME & CHARGES
(24)
(56)
(170)
280
RESULT FOR THE PERIOD
(4,457)
(6,017)
(14,654)
(16,733)
(450) (160.6)
2,079
12.4
Net financial position
(amounts in € thousand)
30 September
2013(a)
30 June
2013(b)
31 December
2012
NET FINANCIAL POSITION
9,968
13,704
17,526
Variation
(a-b)
%
(2,736)
(21.5)
Key achievements in the first nine months of 2013
Research & Clinical Development activities
In the first nine months of 2013, the Company’s activities focused mainly on clinical development of its two
investigational anticancer therapeutics: TK for the treatment of high-risk leukaemia and NGR-hTNF for the
treatment of a number of solid tumours.
TK main achievements include:
expansion in the US of the pivotal Phase III trial (TK008) of its proprietary TK cell therapy for highrisk leukaemia patients. The study, already ongoing in Europe, foresees patient enrolment in 16
clinical centres in Europe, United States and Israel;
presentation at ASCO 2013 and at the BMT Tandem Meetings 2013 of positive long-term safety and
efficacy data with its cell therapy product TK for the treatment of hematologic malignancies with bone
marrow transplantation from partially matched (haplo-identical) donors. The seven year follow-up
analysis of this large patient population indicates that overall and disease-free survivals from
haploidentical family donors are fully comparable to those obtained from fully matched donors;
progress on dossier preparation in order to file for a market authorisation application for TK through
a special procedure (Conditional Marketing Authorisation) with the European Medicines Agency.
This request is based on the rarity of the indication (TK has obtained Orphan Drug designation), the
favourable risk/benefit ratio and the demonstration of safety and clinical efficacy obtained in more
than 120 patients treated so far. The Company expects to file this request with the European
authority in 2013.
NGR-hTNF main achievements include:
presentation at the European Cancer Congress 2013 (ECCO-ESMO-ESTRO) of new data showing a
statistically significant doubling of the median survival - associated with a favourable tolerability
profile - of patients treated weekly with low doses NGR-hTNF in combination with doxorubicin in the
randomised Phase II study in soft tissues sarcomas;
completion of patient enrolment in a randomised Phase II trial in platinum-resistant/refractory ovarian
cancer patients. Results of the study are expected in the first half of 2014;
presentation at ASCO of positive results from a randomized Phase II study evaluating safety and
efficacy of its investigational drug NGR-hTNF in combination with standard chemotherapy for the
FROM GENES TO THERAPY
2
3. PRESS RELEASE
first-line therapy of non-small cell lung cancer (NSCLC) patients with squamous histology. The
addition of NGR-hTNF to standard chemotherapy induced a two-fold higher tumour shrinkage and,
most importantly, a statistically significant 50% reduction in the risk of death compared to
chemotherapy alone (p=0.04). Notably, these efficacy outcomes were coupled with a favourable
tolerability profile.
Development and GMP production for third parties
Development and production of new cell and gene therapy treatments for third parties are consolidating the
company's technological leadership in this field, and are also generating a significant increase in revenues
(as described in the Comments to financials). During the first nine months of 2013, activities continued under
two major agreements signed in 2011, respectively with Telethon Foundation and GlaxoSmithKline, for the
development and production of investigational gene therapies for a total of seven rare diseases.
Furthermore, the GMP production facility has been upgraded and optimized.
Of particular relevance is the publication of results obtained by the Telethon Foundation concerning two of
the gene therapies for which MolMed develops and manufactures viral vectors and transduces patients
th
hematopoietic stem cell, on July 11 in Science, one of the most internationally renowned scientific journals.
Comments to financials
First nine months of 2013
Revenues in the first nine months of 2013, amounting to € 3.4 million, increased by 11.3% compared to the
first nine months of 2012. This increase is due to the intensification in the development and GMP production
activities for third parties. The abovementioned activities generated revenues of € 3.1 million compared to €
2.8 million in the corresponding period of 2012, with an increase of 11.9% respect to the first nine months of
last year. Other revenues related to public funding for research and development activities, for € 308
thousand, showed an increase compared to the same period of 2012.
Operating costs for the first nine months of 2013 totaled € 17.9 million and show a decrease of € 2.2 million
respect to the first nine months of 2012 (€ 20.1 million). The decrease of 10.9% in operating costs is mainly
due to a reduction of services costs.
The operating loss for the first nine months of 2013, of € 14.5 million, has been reduced by 14.9% respect to
the same figure of the previous year of € 17.0 million.
Financial results are negative for € 170 thousand, decreasing from € 450 thousand respect to the first nine
months of 2012. Financial income, for € 143 thousand (€ 682 thousand at 30 September, 2012) is primarily
derived from the management of the Company’s cash through temporary, low-risk investments. The
decrease of such income in the period is mainly due to the progressive reduction of financial resources due
to the absorption of liquidity for ordinary business and to lower rates of return of the market. Financial costs,
€ 313 thousand in the first nine months of 2013, are mainly due to the pro solute of VAT receivables
transaction finalized in the second quarter of 2013.
The result for the first nine months of 2013 show a loss of € 14.7 million, compared to a loss of € 16.7 million
in the corresponding period of 2012.
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3
4. PRESS RELEASE
Third quarter of 2013
In the third quarter of 2013, operating revenues totalled € 685 thousand, compared to € 639 thousand in the
third quarter of 2012. Operating revenues include € 613 thousand in revenues from development and
production for third parties, higher, in this quarter, respect to the same period last year, due above all to
development and GMP production activities for third parties.
Operating revenues also consist of € 72 thousand in other income, related to public funding for research and
development activities in line with the same period of 2012.
In the third quarter of 2013, operating costs amounted to € 5.1 million, respect to € 6.6 million in the third
quarter of 2012. This downward trend is mainly due to a decrease in services costs compared to the
concentration of costs sustained in the last three quarters of 2012 for the development of NGR015 and to
costs related to pivotal Phase III trial, for which patient enrolment was completed at the end of 2012.
The operating result for the third quarter of 2012 was negative for € 4.4 million, compared to a loss of € 6.0
million in the same period of 2012.
In the third quarter of 2013 result of financial management is negative for € 24 thousand. The negative result
is mainly due to financial costs related to the VAT receivables pro solute transaction finalized in the first half
of 2013.
The result for the third quarter of 2013 shows a loss of € 4.5 million, respect to a loss of € 6.0 million in the
corresponding period of 2012.
Net financial position
The net financial position at 30 September 2013 amounts to € 10.0 million, and includes cash and cash
equivalents for € 12.0 million, financial debt related to the accounting of financial leasing for laboratory
equipment for € 33 thousand and long term financial debts for € 2.0 million related to the recording of the
pro solute transaction of VAT receivables.
It is relevant to note that the Shareholders, members of the shareholders’ agreement, who previously
communicated their availability to support the Company in carrying out its industrial and development plans
until 31 August 2014, for a total amount of €4.3 million, on 11 November 2013 have communicated their
availability to extend their commitment up to, but not beyond, 30 November 2014 and limited to a total
amount of €7.1 million.
The official Corporate Financial Reporting Manager of MolMed S.p.A., Andrea Quaglino, herewith attests,
pursuant to Article 154-bis, paragraph 2 of the Italian Consolidated Law on Finance (Legislative Decree
58/1998), that the accounting disclosure contained in this press release matches documentary evidence,
corporate books, and accounting records.
In this press release, use is made of “alternative performance indicators” which are not provided for under
European IFRS, and whose significance and content - in line with Recommendation CESR/05-178b
published on 3 November 2005 - are illustrated below:
Operating Result: defined as the difference between sales revenues and other income and costs for
materials, costs of services received, costs for use of third-party assets, personnel costs and
amortisation, depreciation & write downs. It represents the profit before financial flows and taxes;
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5. PRESS RELEASE
Net Financial Position: is the algebraic sum of cash, cash equivalents, financial receivables and
other financial assets, and current and non-current financial debt.
This press release is written in compliance with public disclosure obligations established by CONSOB (Italian
securities & exchange commission) resolution no. 11971 of 14 May 1999, as subsequently amended.
About MolMed
MolMed S.p.A. is a biotechnology company focused on research, development and clinical validation of
novel anticancer therapies. MolMed’s pipeline includes two antitumour therapeutics in clinical development:
TK, a cell-based therapy enabling bone marrow transplants from partially compatible donors, in absence of
post-transplant immune-suppression, in Phase III in high-risk acute leukaemia; NGR-hTNF, a novel vascular
targeting agent, in Phase III in malignant pleural mesothelioma and in Phase II in six more indications:
colorectal, lung (small-cell and non-small-cell), liver and ovarian cancer, and soft tissue sarcomas. MolMed
also offers top-level expertise in cell and gene therapy to third parties to develop, conduct and validate
projects from preclinical to Phase III trials, including scale-up and cGMP production of clinical-grade viral
vectors, and manufacturing of patient-specific genetically engineered cells. MolMed is headquartered at the
San Raffaele Biomedical Science Park in Milan, Italy. The Company’s shares are listed on the main market
(MTA) of the Milan Stock Exchange. (Ticker Reuters: MLMD.MI)
FROM GENES TO THERAPY
5
6. PRESS RELEASE
Financial statements at 30 September 2013
Income statement
(amounts in Euro thousands )
3rd quarter
2013
3rd quarter
2012
1.1.201330.09.2013
1.1.201230.09.2012
Variation
(*)
(a)
(b)(*)
(a-b)
Variation
%
Revenues
613
567
3,101
2,770
331
11.9%
Other revenue
Total operating revenues
72
685
72
639
308
3,409
292
3,062
16
347
5.5%
11.3%
444
2,220
289
2,021
46
98
417
3,828
255
1,859
102
140
1,620
8,364
820
6,532
122
435
1,416
11,311
770
5,942
195
442
204
(2,947)
50
590
(73)
(7)
14.4%
(26.1%)
6.5%
9.9%
(37.4%)
(1.6%)
5,119
(4,434)
6,600
(5,961)
17,894
(14,485)
20,076
(17,014)
(2,182)
2,529
(10.9%)
14.9%
39
62
(24)
179
235
(56)
143
312
(170)
(4,457)
(6,017)
(14,654)
Purchases of raw materials and consumables
Costs for services
Costs for use of third-party assets
Personnel costs
Other operating costs
Amortization, depreciation and write-downs
Total operating costs
Operating result
Financial income
Financial charges
Net financial income (charges)
Pre-tax result
Income taxes
Profit (loss) for the year
(4,457)
682
402
280
(16,733)
(6,017)
(539) (79.1%)
(90) (22.3%)
(450) (160.6%)
2,079
-
(14,654)
12.4%
-
(16,733)
-
2,079
12.4%
Statement of comprehensive income
(amounts in Euro thousands )
Other comprehensive income, net of taxes (not subsequently
reclassified to the income statement)
Other comprehensive income (subsequently reclassified to the
income statement)
Profit (loss) actuarial
Other comprehensive income, net of taxes (subsequently
reclassified to the income statement)
Total comprehensive income (loss) for the year
3rd quarter
2012
1.1.201330.09.2013
1.1.201230.09.2012
Variation
Variation
(*)
Profit (loss) for the year
Other comprehensive income (not subsequently reclassified to the
income statement)
Profit (loss) actuarial
Tax effect on other components of comprehensive income
3rd quarter
2013
(a)
(b)(*)
(a-b)
%
(4,457)
(6,017)
(14,654)
(16,733)
2,079
(2)
(2)
(2)
(2)
-
-
(2)
(2)
(2)
(2)
-
-
-
285
-15
320
-335
(104.7%)
-
285
(15)
320
(335)
(104.7%)
(5,734)
(14,671)
(16,415)
(4,459)
12%
1,744
(10.6%)
(*) Following the adoption, from 1st January 2013, retrospectively of amendment of IAS 19 - Liabilities for pensions and employee severance indemnity (TFR), P&L values related to 1st nine months
of 2012 and financial assets at December 31, 2012 have been consistently restated.
FROM GENES TO THERAPY
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7. PRESS RELEASE
Net financial position
(amounts in € thousand)
Cash on hand
Other cash
Cash equivalents
A. Total cash and cash equivalents
B. Current financial receivables and other financial assets
Finance lease payables
C.Current financial debt
D. Net current financial position (A+B+C)
Finance lease payables
Non current financial debts
E. Non-current financial debt
F. Net financial position (D+E)
September, 30 December, 31
2013
2012
14
12,001
12,015
(33)
(33)
11,982
(2,014)
(2,014)
9,968
11
2,410
8,000
10,421
7,229
(119)
(119)
17,532
(5)
(5)
17,527
For further information:
Marina Del Bue
General Manager Business & Administration
MolMed S.p.A.
phone: +39 02 21277.371
fax: +39 02 21277.325
e-mail: investor.relations@molmed.com
Andrea Quaglino
Director Administration, Finance & Control
MolMed S.p.A.
phone: +39 02 21277.302
fax: +39 02 21277.404
e-mail: afc@molmed.com
DISCLAIMER
This press release may contain certain forward-looking statements. Although the Company believes its expectations are
based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties,
including scientific, business, economic and financial factors, which could cause actual results to differ materially from
those anticipated in the forward-looking statements. The company assumes no responsibility to update forward-looking
statements or adapt them to future events or developments. This document does not constitute an offer or invitation to
subscribe or purchase any securities of MolMed S.p.A.
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