Record profits for Cosmo in 2013
Uceris® has very strong market entry
Management structure expanded
Confident outlook for 2014 - expansion into USA
Lainate, Italy - 27 March 2014 - Cosmo Pharmaceuticals S.p.A. (SIX: COPN)
today announced its results for the year ended 31 December 2013.
Part of financial investment in Santarus sold for a gain of EUR58.2
â? million, resulting in substantial increase of profit after tax to EUR68.7
â? Comprehensive income of EUR80.5 million, driven by increase in value of the
remaining Santarus' shares.
â? Slightly lower operating revenue of EUR56.4 million; 2012 revenue included
non-recurring milestones from partnership agreements.
Research and development at EUR17.6 million, up from EUR10.9 million i.e.
â? related to the phase II & III costs of the CB-17-01 Methylene Blue MMX® and
the phase II clinical trial for CB-03-01 Acne.
â? Cash, cash equivalents and current financial assets available for sale
increased to EUR168.1 million.
â? The equity ratio increased from 81.9% to 90.6%.
Lialda®/Mezavant®, Cosmo's first licensed MMX® product in the market, had
â? USD 528.9 million sales in 2013, an increase of 32.3%, reaching a market
share of 29% of all 5-ASA products in the USA.
â? Uceris® launched in mid February 2013, attained sales of USD 66.3 million
Key consolidated financial figures
In EUR million
(with the exception of the share data in EUR)
Revenues 56.4 59.5
Cost of sales (19.2) (16.2)
Research and development costs (17.6) (10.9)
Selling, general and administrative costs (7.7) (6.0)
Profit before taxes 71.7 26.9
Net profit 68.7 19.3
Profit per share 4.81 1.41
Cash and cash equivalents 46.3 27.3
Current financial assets available for sale 121.8 0
Non current financial assets available for sale 15.5 66.1
Equity attributable to owners of the company 220.1 124.4
Total assets 243.0 151.8
Key strategic events
â? Uceris® (in the USA) and Cortiment® (in the Netherlands) were approved in
Rifamycin SV MMX® rights in the USA were regained (Santarus acquiror Salix
â? returned rights because of non compete undertakings in the agreement Cosmo
had with Santarus).
New Indian clinical trial requirements forced move of second pivotal
â? infectious colitis trial from India to Latin America and delay of trial
completion to H1 2015.
â? CB-17-01 Methylene Blue MMX® on track with Phase III trial.
â? Phase II ascending dose trial of CB-03-01 for Acne on track (completed
â? Decision to establish a new US subsidiary to market all non licensed
products in the USA.
â? Decision not to license Methylene Blue MMX® in the USA.
In his last public announcement before handing over to new CEO Alessandro
Della Chà, Mauro Ajani, Executive Chairman of Cosmo Pharmaceuticals said: "I
am very pleased with our results: Both Lialda and Uceris are performing
exceedingly well and demonstrate the superiority and versatility of our MMX®
technology. We decided not to license out Methylene Blue MMX®. So we gave up
potential milestones but I am confident that this will be more than
compensated by allowing a much more profitable exploitation with our new US
operations. We however intend to license out the product in the rest of the
world as soon as we have the full set of clinical phase III data which we
expect at the end of this year."
Alessandro Della Chà, incoming CEO, continued: "Mauro has transformed this
company from a contract drug manufacturer with practically no revenues and no
future into a highly entrepreneurial and profitable company which is
recognized world-wide as an innovator in the treatment of colon diseases. I am
now looking forward to leading Cosmo in its next steps, most importantly our
expansion into the USA. The new US venture is fully funded by the cash we
gained on the extraordinary Santarus investment. I am very optimistic for the
Post closing events
â? On January 2, 2014 Cosmo sold its remaining Santarus shares which caused a
financial gain of EUR65.1 million.
On February 25, 2014 Cosmo announced the successful conclusion of its share
â? buy back in which it purchased 599'830 COPN shares at a price of CHF 93.25.
These shares are reserved for its Management Stock Based Compensation
On March 11, 2014 Cosmo purchased 15.4% of the shares of BioMAS (an Israeli
company dedicated to the development of tellurium based drugs) for USD 2
â? million, and entered into a license agreement for the world wide rights to
all tellurium based topical applications (except for alopecia) for a USD 1
million up front payment and subsequent royalties.
On March 26 Alessandro Della Chà took up his functions as CEO. Mauro Ajani
â? will continue acting as Chairman. Giuseppe Celasco is retiring as CMO (he
will remain active as a consultant). Alessandro Mazzetti succeeds him as of
April 1, 2014, he joined Cosmo in 2014 as medical director.
On the basis of the achieved results, the Board proposes the payment of an
extraordinary dividend of EUR 1.00 per share for approval to the General
Assembly of Shareholders which will take place in Lainate on April 16, 2014.
Upon approval, payment will be effected value April 30, 2014 for all
shareholders of record date April 28, 2014.
According to the projections of Salix financial analysts, Cosmo's revenues
from Uceris should increase substantially. A USD 5 million milestone is due at
USD 75 million Uceris sales per annum and USD 17.5 million are due when USD
150 million revenues are reached. Cosmo will manufacture all Uceris tablets
and look to receiving 22% on yearly revenues of up to USD 120 million and 24%
on revenues above that. In the rest of the world partner Ferring is gearing up
Cortiment for the launch in over 80 countries. Net sales of Lialda®/
Mezavant®/Mesavancol® are also projected to increase but we will reach our
royalty cap by mid year. Management expects to successfully conclude the phase
II CB-03-01 acne trial; a USD 20 million milestone is due to Cosmo by Valeant
Cosmo looks forward to progressing CB-17-01 (Methylene Blue MMX®) through
phase III and CB-03-01 through its proof of concept for alopecia and is
confident that the European phase III trial of Rifamycin SV MMX® will finally
get completed in Latin America. The Company is financing the programmes for
Methylene Blue MMX®, CB-03-01 for alopecia, AS 101 for genital warts, so R&D
costs are scheduled to increase to EUR 25 million in 2014.
A strong emphasis will remain on cost control. Neither cost of goods nor SG&A
are expected to increase materially. Overall, while there are some timing
uncertainties, Cosmo expects to post a substantial increase both in operating
revenues to approx. EUR 100 million and strong growth in operating profits as
well as net income in 2014.
The Annual Report 2013 with further information, amongst other the invitation
to the General Assembly of April 16, 2014 in Lainate was published on the
Company's web site on 27 March 2014. The Annual Report is available for
FY13 results presentation and conference call at 10am CET on 27 March 2014
Mauro Ajani, Chairman, Alessandro Della Chà, CEO, Luigi Moro, CSO, and Chris
Tanner, CFO and Head of Investor Relations, will present the full year results
and discuss the outlook for 2014 at a media and analyst conference to be held
today at 10am CET in Haus zum Rüden (Limmatquai 42, 8001 Zurich).
Participation is also possible via conference call. The dial-in numbers:
+41 (0) 58 310 50 00 Continental Europe
+44 (0) 203 0595 862 UK
+1 631 570 56 13 USA
The presentation is available for download at:
The media and analyst conference will be made available as an audio recording
this afternoon and as a transcript tomorrow afternoon at:
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company that aims to become a global
leader in the field of optimized therapies for selected Gastrointestinal and
topically treated Skin Disorders. The company's proprietary clinical
development pipeline specifically addresses innovative treatments for IBD,
such as Ulcerative Colitis and Crohn's Disease, and Colon Infections. In
addition, the Company is developing a diagnostic for the detection of colon
cancer and a new chemical entity for the topical skin treatment. Cosmo's MMX®
products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a
treatment for IBD that is licensed globally to Giuliani and Shire Limited and
Uceris®, the first glucocorticosteroid indicated for the induction of
remission in active, mild to moderate ulcerative colitis, licensed in US to
Salix and in the Rest of the World except for Japan to Ferring. Cosmo's
proprietary MMX® technology is at the core of the Company's product pipeline
and was developed from its expertise in formulating and manufacturing
gastrointestinal drugs for international clients at its GMP (Good
Manufacturing Practice) facilities in Lainate, Italy. The technology is
designed to deliver active ingredients in a targeted manner in the colon. For
further information on Cosmo, please visit the Company's website:
Annual General Meeting 16 April 2014, Lainate
Half-year results 2014 30 July 2014
Dr. Chris Tanner, CFO and Head of Investor Relations
Cosmo Pharmaceuticals S.p.A.
Tel: +39 02 9333 7614
Some of the information contained in this press release contains
forward-looking statements. Readers are cautioned that any such
forward-looking statements are not guarantees of future performance and
involve risks and uncertainties, and that actual results may differ materially
from those in the forward-looking statements as a result of various factors.
Cosmo undertakes no obligation to publicly update or revise any
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