Dublin, Ireland – 26 March 2018 – Cosmo Pharmaceuticals N.V. (SIX: COPN) reports Full-Year results for the period ended 31 December 2017.
Financial Highlights Full-Year 2017
- Revenue € 67.2 million vs € 67.7 million in 2016
- Operating costs € 76.8 million, up € 33.8 million vs 2016, the increase mainly related to building up our marketing and sales organization in the US and Eleview launch costs
- Resulting in a loss after tax of € 32.5 million, including FX loss of € 18.7 million on our US$ liquidity position
- Cash and bonds € 247.2 million, up € 28 million vs 2016, also reflecting the private placement of Company shares, less the dividend paid in May 2017
- Equity position increased by € 55 million to € 470.1 million
Key Events 2017 – Products and Business
Eleview, Methylene Blue MMX and Qolotag
- Started to build up a sales and marketing organization to commercialize our products in the US. At year end, 91 people hired, of which 67 in marketing and sales and 12 in Medical & Scientific Liaisons
- Launched Eleview in the US, after the successful clinical trial vs standard of care in endoscopic mucosal resection of large sessile polyps. To boost sales, established a co-promotion agreement with Olympus America Inc
- Entered into distribution agreement with Fujifilm for Eleview in Europe and South Africa
- Methylene Blue MMX New Drug Application (NDA) accepted by the US Food and Drug Administration (FDA) with a target completion date for review of 21 May 2018
- New Methylene Blue MMX manufacturing plant in Lainate, Italy, completed and subsequently approved by the FDA
- CE mark granted and approval for marketing in the EU obtained for Qolotag, our medical device designed to enhance the detection of small lesions or dysplasia’s during sigmoidoscopy
Rifamycin SV MMX and Remimazolam
- Rifamycin SV MMX granted both QIPD and Fast Track by the FDA. If approved, an 8-year exclusivity will be granted, NDA filed on 19 March 2018
- Dr. Falk Pharma, our licensee for Europe and selected countries excluding the US, filed for marketing authorization of Rifafalk 200mg (Rifamycin SV MMX tablets)
- Rifamycin SV MMX phase II clinical trial for a second indication for diarrhea-predominant irritable bowel syndrome (IBS-D) commenced, first patient randomized in December
- Remimazolam, a fast-acting intravenous benzodiazepine agent in-licensed by Cosmo from PAION AG, successfully concluded its US phase III clinical trials in procedural sedation in patients undergoing bronchoscopy and II/IV ASA patients, meeting the primary endpoint and paving the way for NDA filings
Key figures
| EUR /000 | 2017 | 2016 |
| Income statement | ||
| Revenues | 67,242 | 67,664 |
| Other income | 470 | 730 |
| Cost of sales | (21,988) | (19,851) |
| R&D costs | (9,049) | (8,257) |
| SG&A costs | (46,279) | (15,659) |
| Share of result of associates | (5,892) | (3,622) |
| Operating (loss) / profit | (15,496) | 21,005 |
| Net financial (expense) / income | (16,936) | 6,486 |
| (Loss) / profit before taxes | (32,432) | 27,491 |
| (Loss) / profit after taxes for the period | (32,447) | 19,340 |
| Statement of financial position | ||
| Non-current assets | 300,668 | 256,400 |
| Cash and cash equivalents | 144,944 | 117,649 |
| Other current assets | 52,362 | 69,425 |
| Liabilities | 27,857 | 27,916 |
| Equity attributable to owners of the Company | 470,117 | 415,546 |
| Equity ratio (%) | 94.4% | 93.7 % |
| Shares | ||
| Weighted average number of shares | 14,809,753 | 14,103,536 |
| Earnings per share (in EUR) | (2.191) | 1.371 |
The Full-Year Report 2017 with further information was published on 26 March 2018, 07:00 am CET, and is available for download at:
http://www.cosmopharmaceuticals.com/investor-relations/financial-reports
Confident Outlook
Alessandro Della Chà, Chief Executive Officer, said: “During 2017 we have set up our own US commercial organization, launched Eleview in the US and further progressed our pipeline. We believe that the ongoing build-up of our own specialty sales organization in the US will be the key driver to create substantial shareholder value in the mid-term. Our primary focus for 2018 will be, subject to regulatory approval, to launch Methylene Blue MMX in the US, to further expand our US sales and marketing capability, to continue pre-commercial activities for Rifamycin SV MMX, to file the Remimazolam NDA and to progress our Rifamycin SV MMX IBS-D phase II trial. All of these activities will result in an operating loss of approximately € 40 million in 2018 before we expect to return to profit in 2019.”
Full-Year 2017 results conference call at 10:00 am CET on 26 March 2018
Alessandro Della Chà, CEO and Niall Donnelly, CFO, will present the 2017 results and discuss the outlook for 2018. The conference will be held in English.
Date: Monday, 26 March 2018
Time: 10:00 am – 11:30 am CET
Venue: Haus zum Rüden, Constaffelsaal, Limmatquai 42, 8001 Zurich
Participation is also possible via conference call.
The dial-in numbers are:
Continental Europe: +41 (0) 58 310 50 00
UK: +44 (0) 207 107 06 13
USA: +1 (1) 613 570 56 13
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 has developed and launched in the US Eleview, a medical device for polyp and adenoma excision and it has filed the NDA for Methylene Blue MMX, a diagnostic drug for the detection of colon cancer, as well as 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 drugs 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 Santarus/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
Contact:
John Manieri, Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
jmanieri@cosmopharma.com
Disclaimer
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.
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