Cosmo Reports Excellent Final Full Year 2023 Financial Results – Increases Operating Profit Guidance for 2024 – Dividend of 2.00 per Share Will Be Proposed at EGM on 5 July 2024

Ad hoc announcement pursuant to Art. 53 LR

Dublin, Ireland–(Newsfile Corp. – May 31, 2024) – Cosmo Pharmaceuticals N.V. (SIX: COPN) (FSE: C43) (“Cosmo”) today announced its final audited results for the financial year 2023.

Financial highlights

As previously announced when publishing preliminary unaudited 2023 figures on 20 March 2024, Cosmo delivered strong growth across its core business in 2023. The core business performed follows in 2023:

• Revenues € 92.8 million
• EBITDA of € 20.4 million
• Operating profit € 6.1 million
• Profit before taxes € 1.5 million
• Net cash inflow from operating activities € 33.6 million
• Equity attributable to owners of the Company of € 422.2 million
• Treasury shares, at market value at 31 December 2023, of € 81.9 million
• € 175m convertible bond fully reimbursed in cash at maturity in December 2023
• No. 221,373 treasury shares purchased in 2023, total of 1,490,681 treasury shares held at year end and 1,496,085 at 30 April 2024
• The Group is debt-free
• Net cash position as of 30th of April 2024 € 136.1 million
• A dividend distribution of € 2.00 per share (an increase of 90.5% versus last year) will be proposed to investors at an EGM scheduled for 5 July 2024

In December 2023, Cosmo IMD (Intelligent Medical Devices), a division of Cosmo, expanded its partnership with Medtronic. The 1st USD 100 million payable under the new agreement was received in Q1 2024, a further USD 100 million is expected to be received by the end of 2024. This agreement has further strengthened the company’s financial position and enables an acceleration of investment in exciting opportunities in both pharma and AI, as well as an increase in our dividend. The new agreement became effective in 2024 however Cosmo has recognised € 5.9 million of related costs in its 2023 financial statements, revenue will be recognised from 2024.

Giovanni Di Napoli, CEO of Cosmo, commented: “Today we have published our final results for 2023 and increased our 2024 operating profit guidance by € 4.4 million to a range of € 159.4 million – € 169.4 million. Our core business is growing, we are generating healthy operating cashflows and the expansion of our AI partnership with Medtronic represents a major opportunity for Cosmo. This is a very exciting time for the company, we are in a solid financial position and we are poised for further growth. We invite shareholders to an Extraordinary General Meeting on 5 July 2024 to approve the proposed dividend of € 2.00 per share for the business year 2023.” 

Cosmo’s two key growth drivers, GI Genius and Winlevi, continue to perform in line with expectations 

GI Genius: new agreement with Medtronic, FDA clearance of new operating system and meaningful expansion of customer base

• Installed customer base grew at an impressive pace
• New agreement announced December 2023 with Medtronic including $ 100 million upfront cash payment, received in February 2024, additional $ 100 million payment expected to be received in 2024
• Obtained FDA clearance for enhanced new GI Genius operating system
• Substantial advance in development of new features

Winlevi continues to be the #1 prescribed branded topical acne product in the U.S.

• More than 1,000,000 TRx (prescriptions) since launch
• Over 17,900 unique prescribers, representing >90% of total healthcare practitioners in dermatology
• New commercial partnerships executed to make Winlevi available in EU, UK, South Africa, Middle East, North Africa, South Korea
• Winlevi launched in Canada and was approved in Australia by our partner Sun Pharmaceuticals
• Marketing authorization application (MAA) filed for approval with European Medicines Agency (EMA)
• Working on Winlevi life extension and expansion in other dermatology indications

Development pipeline highlights

• Breezula (clascoterone solution), phase III trial in males for the treatment of androgenetic alopecia started in H1 2023. Study recruitment is progressing on schedule, with 348 out of a planned 726 patients recruited in study CB-03-01/37 and 507 of 726 in study CB-03-01/38.
• CB-03-10 (cortexolone 17α-valerate-21-propionate tablets), phase I study ongoing in patients with advanced refractory solid tumors. To date, 13 patients were treated and completed the safety observation period, with an excellent safety profile.
• CB-01-33 (colesevelam tablets) to treat bile acid diarrhea. Phase II scheduled to start in Q4 2024.
• CB-01-35 (rifamycin enema), an innovative enema solution which transforms into a bioadhesive gel once administered, using rifamycin as active substance, for the treatment of distal Ulcerative Colitis and Proctitis. Phase II study started at the end of April, enrollment of about 120 patients anticipated in 25 European sites. Phase II readout (top-line results) expected in Q1 2026.

Final audited figures:

Increased 2024 Guidance

The Company has increased its 2024 operating profit guidance by € 4.4m to a range of € 159.4 million to € 169.4 million. 

• Total revenues in the range of € 260 million – € 270 million (including a € 100 million upfront payment from expansion of the agreement with Medtronic announced in December 2023) versus € 92.8 million in 2023
• Operating profit in the range of € 159.4 million – € 169.4 million versus € 6.1 million in 2023

Outlook 2025

• Total revenues expected in the range of € 240m – € 260m

Comparison of preliminary vs. final results

The Company published the preliminary unaudited figures on March 20, 2024. A reconciliation between the unaudited figures and the final audited figures is as follows:

1. Costs related to new Medtronic agreement

The Company has recognised € 5.9m of costs in its 2023 financial statements related to its new agreement with Medtronic which became effective in 2024. This generated an increase in 2024 operating profit guidance of € 4.4m.

On 8 December 2023, Cosmo executed a supply and distribution agreement with Medtronic (the “New Medtronic Agreement”), this agreement was subject to certain closing conditions which were fulfilled on 20 February 2024 and the New Medtronic Agreement became effective on 21 February 2024.

Under the terms of the New Medtronic Agreement, Medtronic paid Cosmo $ 100 million upfront in February 2024 and agreed to pay up to an additional $ 100 million, which is expected to be reached by the end of 2024, as well as a double-digit royalty on net sales. Notwithstanding that the New Medtronic Agreement was executed on 8 December 2023, revenue can only be recognised after the agreement became effective and when (or as) performance obligations are satisfied under IFRS 15.

On 6 December 2023, linked to the New Medtronic Agreement, Cosmo executed an agreement with the certain former NCI shareholders of Linkverse S.r.l. (the “New Linkverse Agreement”) which modified the terms of contingent consideration and the share-based payments originally agreed in 2019. The effectiveness of the New Linkverse Agreement was contingent upon the effectiveness of the New Medtronic Agreement and therefore the New Linkverse Agreement is linked to the New Medtronic Agreement. However, under the relevant IFRS standards the Company is required to recognise costs related to the New Linkverse Agreement in 2023.  Consequently, the consolidated net result for year 2023 is impacted by the New Linkverse Agreement, while the revenue related to the New Medtronic Agreement is not yet recognised in 2023. The Company presents a separate line item for the impact of the aforementioned cost recognition related to the New Medtronic Agreement as this is not a recurring cost item.

The costs related to the New Medtronic Agreement are as follows (EUR’000):

2. Reclass reversal of contract asset

The Company has reclassified the reversal of a contract asset as a deduction from revenue rather than a deduction from SG&A costs, there is no adjustment to operating profit as a result of this item.

Downloads

This media release (https://www.cosmopharma.com/investors/news-and-media) and Annual Report 2023 (https://www.cosmopharma.com/investors/financial-reports) is available on Cosmo’s website.

About Cosmo

Cosmo is a pharmaceutical company focused on developing and commercializing products to treat selected gastrointestinal disorders, to improve endoscopy quality measures through aiding the detection of colonic lesions, and to treat selected dermatological conditions. Cosmo develops and manufactures products which are distributed globally by selected partners including Lialda®/Mezavant®/Mesavancol®, Uceris®/Cortiment®, Aemcolo®/ Relafalk®, Lumeblue® and Winlevi®. Cosmo has also developed medical devices for endoscopy and has a partnership with Medtronic for the global distribution of GI Genius™ which uses artificial intelligence to help detect potential signs of colon cancer. The company also has a rich development pipeline. For additional information on Cosmo and its products please visit the Company’s website: www.cosmopharma.com

Upcoming Calendar of Events

ODDO BHF Nextcap Forum 2024                                June 6, 2024

Extraordinary General Meeting                                    July 5, 2024

Half Year Results 2024                                                July 24, 2024

Contact

Hazel Winchester

Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70

hwinchester@cosmopharma.com

Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

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