Watch Cyclopharm’s 2023 Annual General Meeting presentation

The 2023 Cyclopharm Annual General Meeting (AGM) held on 16 May 2023 showcased the company’s solid financial performance in FY 2022 and significant progress in executing growth initiatives. Chaired by David Heaney, the meeting brought together company directors along with a number of shareholders and stakeholders, to delve into the company’s recent successes and its strategic vision moving forward.

Chairperson’s Address

David Heaney, Chair of Cyclopharm Limited, set the tone for the AGM with an inspiring address. He provided a comprehensive overview of the company’s stellar financial performance in 2022. He emphasized the outstanding growth in the third-party distribution business and the substantial progress made with the United States Food and Drug Administration (FDA) toward gaining approval for Technegas products in the U.S. Notably, Heaney highlighted the company’s record-breaking revenue performance in 2022, driven by increased sales and diversification.

Business Update

James McBrayer, the Managing Director of Cyclopharm, took the stage to deliver an all-encompassing business update. He discussed the core Technegas products, their presence in 64 countries, and their esteemed reputation as a global leader in nuclear medicine functional lung ventilation imaging. McBrayer underscored the ongoing efforts to secure FDA approval for U.S. sales, a move that represents a significant business opportunity. He also noted the resounding success of the third-party distribution business, substantial revenue growth, and expansion into new markets.

Financial Performance

The financial performance of Cyclopharm in 2022 was another topic of discussion. Despite challenges related to COVID-19 and supply chain disruptions, the company achieved an impressive 31.1 percent increase in sales revenue. Cyclopharm boasted a robust balance sheet with no debt and a cash reserve of $20.3 million, positioning it favorably for future growth.

Legal Matters

Cyclopharm has been resolute in defending its intellectual property, successfully resolving litigation against former employees alleged to have breached confidentiality agreements. The meeting also touched upon the legal expenses related to these matters.

Operational Highlights

Operational highlights for 2022 included the utilization of Technegas by over 167,000 patients, marking an 8.7 percent increase from the previous year. Sales of core Technegas products grew by 4.1 percent, reaching $13.7 million, matching pre-pandemic levels. Additionally, the company spotlighted its recurring revenues from the sale of patient administration sets and consumables.

Future Growth

Cyclopharm’s forward-looking strategy centers on leveraging its intellectual property, technology, and technical expertise. Plans are in motion to expand into new countries, broaden product applications, and explore complementary businesses.

US FDA Approval

A major highlight was the company’s progress toward securing FDA approval for U.S. sales of Technegas. A target completion date for the review process was set for September 29, 2023, with an inspection of manufacturing facilities on the horizon.

Exceptional Third-Party Revenue Growth

Cyclopharm’s prowess in generating third-party revenue was underlined, with particularly robust performance in Europe and exceptional growth in the Asia-Pacific region. The company’s regulatory expertise and operational footprint were pivotal in scaling this third-party business. Key agreements for Europe in 2020 and the Asia Pacific in 2021 laid the foundation, and in 2022, the third-party distribution business more than doubled its revenue contribution, driven by consumables, radio pharmaceutical sales, and service support.

Corporate Governance

Corporate governance emerged as a highlight in 2022, with the strengthening of the Cyclopharm board, reflecting the company’s commitment to transparency and responsible management.

Regulatory Approvals and New Applications

In existing markets, Cyclopharm achieved regulatory milestones, including the renewal of Technegas’ CE mark under updated European medical device regulations (MDR) and licensing renewal under the Medical Device Single Audit Process (MDSAP) for participating countries like Canada, Australia, Brazil, and Japan. The meeting also explored new applications beyond pulmonary embolism (PE) for Technegas, particularly in respiratory medicine, with several clinical trials underway to investigate these new avenues.

Strategic Growth in the US Market

The company outlined a growth strategy for the U.S. market, focusing on providing Technegas generators on a lease basis, with the aim of rapid market penetration.

Potential in Diagnosing Pulmonary Embolism

The AGM delved into the potential of Technegas in diagnosing pulmonary embolism in the U.S. market, targeting an initial 50% share, followed by an ambitious 80% share in the long term.

Versatile Technology

The speaker highlighted the simplicity and uniqueness of Technegas’ technology for lung ventilation imaging, emphasizing its potential applications in various respiratory conditions, including COPD, asthma, lung cancer, and more.

Future Growth Phases

Cyclopharm’s vision for Technegas was outlined in three distinct value phases or Horizons, underlining its commitment to innovation and sustained growth.

Investor Expectations

The meeting concluded by outlining key milestones investors can anticipate in the next two years, including the company’s entry into the U.S. market and expansion into chronic indications.

In closing, the speaker expressed gratitude to the dedicated team and shareholders for their unwavering support, radiating confidence in Cyclopharm’s promising future. The 2023 Cyclopharm AGM undoubtedly showcased a company poised for continued success and groundbreaking achievements in the field of nuclear medicine.