
Clonmel-based Shorla Oncology to increase revenues significantly
Ms Sharon Cunningham was commenting on new accounts for the Clonmel-headquartered Shorla Pharma Ltd which show that the group recorded a pre-tax loss of €8.07m in 2023 as the business continued in its development phase.
The pre-tax loss of €8.07m followed a pre-tax loss of €6.2m in 2022.
Last year, Sharon Cunningham and Orlaith Ryan, from Shorla Oncology, were named 2024 EY Entrepreneurs Of The Year.
At the time, Ms Cunningham said: 'Our business is very capital intensive in the product development phase.
It takes several years to develop and commercialise pharmaceutical drugs to start generating revenue and realise a return
Ms Cunningham said that the company is currently conducting another round of fundraising after having already raised $45m.
The accounts show that the company recorded its first revenues in 2023 at €2.49m, and Ms Cunningham said: 'There was a significant increase in revenues in 2024, and we expect another significant increase in revenues this year.'
The company's research and development spend increased from €2.12m to €3.26m in 2023.
Ms Cunningham said: 'We are very pleased with the progress of our business, and we are exactly where we planned to be and want to be from a revenue and pipeline progression perspective."
US market
Ms Cunningham said that the company has currently four FDA approved medicines for the US market and launched the fourth of those this week in the US.
The firm also has a US office at Cambridge, Massachusetts, where Ms Cunningham is based, and she said that the medicines include treatments for breast and ovarian cancer and leukaemia.
The Waterford native said that numbers employed now total 45, adding that she expects employee numbers to increase further this year.
In accounts signed off on March 13, they show that a capital injection of €28.45m in 2023 resulted in the company having shareholder funds of €17.12m at the end of 2023.
Cash funds increased from €4.73m to €14.49m. A note attached to the accounts states that the company meets its day-to-day working capital requirements through existing cash resources and from future funding.
A separate note states that 'the projections indicate that additional funding will be required in 2026, and assume that the company will successfully obtain such funding'.
Asked on the impact of winning the EY Entrepreneur of the Year for 2024, Ms Cunningham said that it has been "phenomenal".
She said: 'It's extremely beneficial to have access to such a dynamic group of successful entrepreneurs and winning the competition overall has provided validation and further credibility of our business."
Ms Cunningham said that the company will be representing Ireland in the world EY Entrepreneur of the year competition in Monaco in June.
Read More
Smurfit Westrock posts 'strong' first quarter after merger
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Irish Independent
18 hours ago
- Irish Independent
Pharma companies warned Government over competitiveness before Trump's tariff war began
Multinationals criticised the impact of EU rules on how they do business Major pharmaceutical companies raised concerns about Ireland's competitiveness, ahead of Donald Trump's opening shots in early April which began the tariff war with the EU. Correspondence released under the Freedom of Information Act to the Sunday Independent show that companies called on the Government to address supply chain issues and ensure there was a diverse and skilled workforce here. They also criticised the impact of EU regulations on how they do business. The warnings from Eli Lilly and Johnson & Johnson came before Mr Trump heightened uncertainty in the sector by announcing sweeping global trade tariffs, and underlined the need for Ireland to react if it is to retain its significant foreign direct investment from the pharma sector. Multinational pharmaceutical companies play a significant role in Ireland's economy. IDA Ireland data shows more than 90 pharmaceutical companies are based here and provide in the region of 45,000 jobs. They also pay billions in corporation tax. US-headquartered Eli Lilly, which employs 3,500 people in Limerick, Cork and on a nationwide commercial team, met with Department of Enterprise officials in February and outlined their concerns around the future of the EU-US trading relationship. Meanwhile, Johnson & Johnson told Enterprise Minister Peter Burke that policy enhancements for business, health and housing 'should be considered in a co-ordinated manner that reflects national strategic priorities'. Trump has threatened future tariffs of between 150pc and 250p on pharma Notes from the Eli Lilly meeting show it told Department of Enterprise and IDA Ireland officials that it wants to see 'greater intensity from Ireland at EU level, specifically around the EU pharmaceutical legislation.' New EU pharma rules, which may be adopted by the end of this year, are designed to address issues around the availability of medicines, how they are produced, and aim to improve competitiveness in the sector. But some businesses raised concerns about the protections for clinical data before it is made available to the manufacturers of cheaper generic versions of drugs. Existing rules allow pharma companies to keep clinical data for eight years. Reforms would reduce this period to six years, although extensions may apply in some scenarios. Officials here said they recognised the need to strike a balance between access to affordable medicines and incentivising innovation. Notes from the Eli Lilly meeting show officials in the Department of Enterprise acknowledged EU-US trade concerns in the pharma sector, saying 'predictability is key for business' and that European engagement would be 'bolstered by expertise from industry'. The company 'also highlighted the importance of de-risking supply chains, ensuring there is a diverse skillset in Irish operations' and said that it 'would like to see more regulation co-operation between the US and EU, especially with the US Food and Drug Administration,' meeting notes stated. A letter sent to Mr Burke by Michaela Hagenhofer, Johnson & Johnson's general manager of commercial operations in Ireland, raised concerns about the European Commission proposing 'to weaken intellectual property incentives for pharmaceuticals… from eight years to six'. The letter stated: 'At European level, it is important that Ireland secures and strengthens its reputation as a life sciences hub by advocating for a competitive business environment. In recent decades, Europe's share of pharmaceutical investment has significantly declined.' A Department of Enterprise spokesman said it supports protecting intellectual property 'and will continue to make the case for this at EU level'. The EU and US last month agreed a 15pc tariff rate would apply on most European goods imported to America. Pharmaceutical goods are not currently the subject of this tariff, but the US is examining its drug supply chains, and levies could be imposed once that analysis concludes. European Commission president Ursula von der Leyen has said any future pharma tariffs would be capped at 15pc. Trump indicated this cap may only be maintained for 'one year, one-and-a-half years maximum' and threatened future rates of between 150pc and 250pc unless pharma companies return production to the US. 'The department welcomes an agreement that will provide much needed certainty to businesses which operate in Ireland and will continue to engage with the Department of Foreign Affairs and the European Commission,' a Department of Enterprise spokesman said. 'The Department has favoured a zero-for-zero arrangement and will continue to argue against any tariffs which may interfere with the closely integrated nature of the Irish and US pharmaceutical sectors.'

Irish Times
3 days ago
- Irish Times
Very small number of investors own vast bulk of shares in Gareth Sheridan's US firm
The wealth of Dublin businessman Gareth Sheridan (35), who is seeking a nomination to run in the forthcoming presidential election , is centred on Florida-based Nutriband, the shares of which are traded on the Nasdaq stock exchange. At a press conference on Thursday, Sheridan said his shares in Nutriband had a value of approximately $16 million , though the value changed with the share price. Other than that, he had savings of approximately €500,000, he said. Company filings show his annual salary as CEO was $150,000, with additional stock options. The company is awaiting the decision of the US Food and Drug Administration (FDA) on regulatory approval for the product it wants to develop, a new, transdermal patch for the safer delivery of the powerful opioid painkiller fentanyl. At the press conference Sheridan said: 'The company is going to be very impactful for thousands of lives a year when that FDA approval comes. I'm very proud of that.' READ MORE A less certain assessment of the situation was made in a market filing from Nutriband when it was issuing new shares in July to fund its ongoing operations. At the time, the loss-making company had an accumulated deficit of $39.8 million. Investors, Nutriband said, should be aware that the company was subject to significant risks. 'If we are not able to obtain FDA approval for our lead product, we may not have the resources to develop any other product, and we may not be able to continue in business,' it said. The company's shares have been trading on Nasdaq since October 2021. On July 2nd, 2025, it had 'approximately 117 holders of record of our common stock', according to the document. [ 'Don't underestimate this guy': Who is Gareth Sheridan, the pharma millionaire running for president? Opens in new window ] Of that small number of shareholders, a key few own the bulk of the company. According to the July document, Sheridan then held 17.65 per cent of the stock. The man who temporarily took over as CEO from Sheridan last week, chairman Serguei Melnik, had 9.39 per cent. Other key figures had smaller percentages, but director Sergei Glinka, who bought his shares last year, had 19.33 per cent. Together these figures, the document said, had 54.39 per cent. 'We have very loyal shareholders who have been with us for a very long time,' Sheridan told the press conference. The July document showed another shareholder, Vitalie Botgros, owned 39 per cent of the company. Botgros is a former chairman of Nutriband and a long-time investor. Cumulatively, therefore, more than 90 per cent of the shares are held by a very small number of investors. Data for the past year shows the daily closing share price has fallen to less than $4 and reached above $10. These price fluctuations directly affect the nominal wealth of each of the major shareholders. The volume of trade has also varied enormously, with a few thousand shares trading on some days, and more than three million on other days, including Friday of last week, when the share price closed at $7.7. [ Co-founder of Gareth Sheridan's US business involved in 2019 Moldova airline privatisation controversy Opens in new window ] Melnik, Glinka and Botgros are all from Moldova (Melnik now lives in the US). Both Glinka and Botgros previously worked (prior to the war in Ukraine) for a now-sanctioned Russian railway rolling stock conglomerate called Transmashholding, associated with a sanctioned Russian billionaire called Iskander Makhmudov. In 2018, there was major controversy in Moldova after the takeover of Air Moldova by a Romanian company in which Melnik was reported to be a 25 per cent shareholder, with a report from a parliamentary inquiry being severely critical of the deal. At his press conference, Sheridan said this had nothing to do with Nutriband or his bid to become President of the Irish Republic.


Irish Examiner
4 days ago
- Irish Examiner
Gareth Sheridan's Nutriband was fined by US government
A cease and desist agreement between presidential hopeful Gareth Sheridan's Nutriband company and the US government in 2018 included a $25,000 fine for the businessman. According to the 2018 document, Nutriband never obtained authorisation from the Food and Drug Administration (FDA) before marketing its products — transdermal patches for the delivery of vitamins and drugs — in the US. Mr Sheridan told Hot Press in an interview last week that the company had received advice that the products would be treated as medical supplements rather than devices and that this had led the Securities and Exchange Commission (SEC) to investigate Nutriband. In late 2018, a cease and desist order was agreed between the two sides, which Mr Sheridan called 'a wake-up call'. The terms of the agreement saw a $25,000 fine each levied against both Mr Sheridan, then the company's CEO, and his business partner Serguei Melnik. The SEC investigation said that according to the company's annual reports for the fiscal years ending 2017 and 2018, Nutriband had no revenue and had incurred a net loss of approximately $2.7m as it developed. In that time, Mr Sheridan and Mr Melnik were its two employees. The SEC's investigation found that Nutriband's transdermal patches consist of a drug and a delivery device, and such drug-device combination products would require FDA approval. It said that six Nutriband public filings with the SEC "contained misleading statements about the FDA's jurisdiction over its products or failed to state that the company's products could not be marketed in the US without FDA approval" and that various filings had "mischaracterised the company's products as 'dietary supplements' not subject to FDA regulation and approval". In July 2018, the company retained an FDA-specific lawyer who "provided an opinion stating that Nutriband's products are regulated as drugs by the FDA" and 'must receive market approval before being sold in the US, which may significantly limit Nutriband's projected sales targets". The document said that both men must cease their previous descriptions of the products and each pay $25,000 to the US government. Former presidential candidate Sean Gallagher is a former chairman of the company, but resigned in January 2022, with his resignation letter citing in part a €154,000 spend on a corporate box for Orlando Magic basketball games. Housing developments Mr Sheridan has also said today that his mother opposed a housing development over concerns it would 'become social housing' at the 'behest of her employer'. This is despite the fact that the project in question was being developed by her employer. Ann Sheridan, who was a director of Mr Sheridan's company Nutriband when it was established in 2012, is listed as a director of several companies involved in property development. However, Mr Sheridan has told the Irish Examiner that this mother works in accounts and administration for a property developer and is not a developer herself. Mr Sheridan has said that his platform for the presidency will partly be based on housing. He said that the questions raised by the Irish Examiner would spur that desire. "Rather than deter me from making housing one of the key elements of my campaign, this merely underscores the dire need to address this kind of practice and conduct within the areas of planning and property development, which serves to slow down the provision of housing and escalate costs."