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Product › Details

LuMeBlue® (Methylene Blu MMX®)

Period Status 2016-07-29 development p3 existent
Organisation Organisation Cosmo Pharmaceuticals N.V. (SIX: COPN)
  Group Cosmo Pharmaceuticals (Group)
     

Cosmo Pharmaceuticals N.V.. (7/29/16). "Press Release: Cosmo Reports Growth in Product Revenues and Progress in Late Stage Product and Corporate Development". Dublin.

Cosmo Pharmaceuticals N.V. (SIX: COPN) announced today its half-year results for the period ended 30 June 2016.


Highlights

> Revenues increased by 58.3% to EUR 31.6 million.

>Profits after tax declined to EUR 5.6 million or by 97.6% because last year’s results were due to the profits on the placing of Cassiopea shares.

> The second phase III pivotal trial of Rifamycin SV MMX® for infectious diarrhoea run by Dr. Falk Pharma was successfully completed with all clinical end points being reached.
> Eleview™, an injectable composition which allows a faster and less risky excision of adenomas or polyps during endoscopy, was approved for marketing in the EU.  

> Methylene Blue MMX® phase III trial in the USA and Europe is almost complete.

> Lialda®/Mezavant®/Mesavancol® continued their growth path.

>Uceris®/Cortiment®:
>> Unsatisfactory revenues attained by Valeant for Uceris®.
>> Ferring continues expanding its footprint with Cortiment® in the rest of world.

> License in of sedation agent Remimazolam from PAION AG and purchase of 9.1% stake in PAION AG.

> Re-incorporation in the Netherlands and move of the headquarters and tax seat to Ireland completed.

> The dividend of EUR 1.40 per share shall be paid out in September 15, 2016, to holders of record on September 1, 2016.


Alessandro Della Chà, CEO of Cosmo Pharmaceuticals, commented: “Excluding the financial gain attained last year, which was primarily due to the successful IPO of Cassiopea, we attained a satisfactory operating result, even-though we are unhappy about the performance of Uceris® under our licensee Valeant. More importantly, we are on track in vastly broadening the product offering and positioning ourselves as a premier player in the endoscopy and gastrointestinal field. I am very glad that the second Rifamycin SV MMX® trial, which was run by our licensee Dr. Falk Pharma and their CRO ICON plc, was finally successful nearly three years after the Santarus trial that was started concurrently. We are taking extra care in the phase III Methylene Blue MMX® trial, which is why we expect data now by Mid-September and we are convinced that this care will provide additional benefits. We expect top-line results to be published soon and will be able to present the data to our investors at the upcoming R&D day which will take place in Zurich in September/October. Together with Eleview™, for which we are conducting marketing trials against standard of care in endoscopic mucosal resection (EMR) and the newly licensed in Remimazolam™ which will be used for faster and safer procedural sedation in endoscopies, we believe that we are in the process of creating an offering for endoscopists and gastroenterologists world-wide that will make their work easier, safer and faster and substantially contribute towards a lowering of the overall colon cancer cost. Furthermore I am glad to announce that we will pay out the dividend of EUR 1.40 per share on September 15, 2016.”

While Lialda® again improved its market penetration and is expected to grow by 8.7% to US$ 340 million in H1 2016, Valeant’s performance continues affecting the development of Uceris® as H1 2016 net sales of US$ 70.6 million are far less than expected. The revenues increase by 58.3% is primarily due to the practically inexistent Uceris® revenues in H1 2015 as Valeant was sorting out the issues with wholesalers.   

Net operating expenses declined by EUR 24.1 million or 55.4% to EUR 19.4 million. This was primarily due to two factors: since no profit over EUR 20 million is forecasted, no accruals have been made on a profit sharing bonus and since the majority of clinical trials are in late phase III, these costs were capitalized. Total personnel employed increased by 5.5% to 192 persons.

Profit before taxes declined to EUR 9.0 million from last year’s EUR 240.2 million which were all due to the profits generated by the placing of Cassiopea shares. In spite of this the taxes due in H1 2016 increased from EUR 2.7 million to EUR 3.4 million because all of the gains attained last year in the placing of the shares were tax free. The basic profit per share, dividing the net profit attributable to shareholders by the weighted average number of ordinary shares during the period reached EUR 0.40.    
Total interest bearing debt declined by 8.8% to EUR 7.4 million. The equity ratio declined slightly from 92.2% to 91.6%. 

In the first half of 2016 the Company re-incorporated in the Netherlands and transferred its headquarters and tax seat to Dublin in Ireland.


Key consolidated financial figures
In EUR million (with the exception of the share data in EUR)

1H 2016
1H 2015

Revenue
31.6
20.0

Cost of sales
(9.6)
(11.1)

Research and development expenses
(3.5)
(13.3)

Selling, general and administrative expenses
(6.3)
(19.2)

Net operating expenses
(19.4)
(43.5)

Net result from disposal of controlling interests
– 
258.5

Share of result of associates
(3.5)

 
Operating result
8.8
235.0

Financial income
2.9
9.5

Financial expenses
(2.7)
(4.3)

Profit before taxes
9.0
240.2

Profit after taxes for the period
5.6
237.5

Profit per share
0.40
16.84
 

30.6.2016
31.12.2015

Cash and cash equivalents
74.2
71.3

Other current assets & receivables
84.4
66.6

Financial assets
112.4
127.1

Investments in associates
141.6
145.1

Other non-current assets
40.0
27.8

Total assets
452.6
437.9

Liabilities
38.2
34.3

Equity attrib. to owners of the company
414.4
403.6


The Half-Year Report 2016 with further information was published on 29 July 2016, 7am CET, and is available for download at:
http://www.cosmopharmaceuticals.com/investor-relations/financial-reports


Post closing event

Establishment of a new Subsidiary Aries Pharmaceuticals Ltd to drive the market penetration in USA.


Outlook

Cosmo’s management expects both Lialda® and Uceris® to continue increasing their market penetration and thus expect revenues to continue growing. Classical operating costs should move within the ranges of H1 2016 but Cosmo will be building up its own distribution organisation in the USA which will cause additional costs. Cosmo expects to enter the market with Eleview™ and file NDAs for Rifamycin MMX® and Methylene Blue MMX® in Q1 2017.

Half-year 2016 results conference call at 10:30 am CEST on 29 July 2016

Alessandro Della Chà, CEO, Luigi Moro, CSO, Niall Donnelly, CFO and Chris Tanner, Head of IR, will present the half-year results and discuss the outlook for 2016 at a conference call to be held today at 10:30 am CEST.

The dial-in numbers:
+41 (0) 58 310 50 00          Continental Europe
+44 (0) 203 0595 862         UK
+1 (1) 631 570 5613           USA

The presentation is available for download at:
http://www.cosmopharma.com/ir/presentations.aspx


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 Disorders and Endoscopic Procedures. 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 medical device for polyp excision as well as a new chemical entities that are being developed by the associate company Cassiopea S.p.A. for the topical treatment of skin diseases. 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/Valeant and in the Rest of the World to Ferring as Cortiment®. 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: www.cosmopharma.com


Next events

Bank am Bellevue Healthcare Day August 28, 2016 in Zurich
Investora Conference September 21, 2016 in Zurich
R&D day September/October 2016 in Zurich
Jefferies Global Healthcare Conference November 16/17, 2016 in London
Credit Suisse Mid Cap Conference November 17/18, 2016 in Zurich
Full-year results 2016 reporting March 2017
Annual General Meeting April 2017


Contact:
Dr. Chris Tanner, Head of Investor Relations
Cosmo Pharmaceuticals N.V.                             
Tel: +352 2784 87 49
ctanner@cosmopharma.com


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 forward-looking statements.

   
Record changed: 2017-08-02

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