Atomo Diagnostics

We are a global company. From our research, development and corporate office in Sydney, Australia; with production capabilities in the U.S.A. and manufacture and distribution in South Africa - we are Atomo.

ICYMI: CEO and Managing Director John Kelly and Financial Controller Suzy Elhlou presented Atomo Diagnostics' H1 FY25 results this morning, Monday March 3. If you would like to catch up on the presentation, please click the link below. https://lnkd.in/gBHqAABE

Atomo Diagnostics is pleased to announce the release of our H1 FY2025 Results Presentation. CEO John Kelly and Financial Controller Suzy Elhlou will host a webinar this coming Monday, March 3 at 11:00AM AEDT to provide shareholders and other interested parties with a summation of the results. To register for the webinar, please click the link below. https://lnkd.in/gPmQ5JAW

Pitt Street Research initiates coverage on Atomo Diagnostics, a company with unique 'user-friendly' Rapid Diagnostic Tests (RDTs). The finger-prick blood-based tests have several advantages including fast results, improved performance and accuracy. The company has for several years commercialised RDTs for HIV/AIDs and has grown its revenues from this indication nine-fold since COVID-19. Since AT1's 2020 IPO, its shares have underperformed for a few reasons, including the reduced levels of COVID testing after 2022, the perception that blood-based diagnostic tests are being superseded by swab testing, and the perception that HIV is less of a problem now that therapies exist. Even though HIV is less deadly, there is still demand for testing, with governments actively procuring them to support national at-home testing programs. And even though Atomo's total revenue was inflated by Covid, its non-COVID revenues are several times ahead of pre-pandemic levels. Moreover, the company is at a pivotal point where it is building a more comprehensive pipeline. It has expanded registration of its HIV Self-Tests to more than 30 countries, is introducing a first in-market rapid test to detect active syphilis, developed with a partner, a new product for blood pregnancy testing that recently obtained CE Mark Approval, and expanded its OEM test cassette supply business so that its Pascal device supports US FDA 510k approval. We value Atomo at $63.4m in a base case and $90.9m in an optimistic case, equating to $0.10 per share and $0.143 per share under the current number of shares on issue but amount to $0.056 per share and $0.08 per share when accounting for future dilution. We see potential for Atomo’s shares to re-rate as the company takes a larger share of the market, commercialises its pipeline of new products and as it transitions to profitability. Please note that this is general advice only and a report Pitt Street has been commissioned to be prepared. Pitt Street directors own shares in Atomo. Please see page 23 for the key risks and the final page for the full general advice warning, disclosure and disclaimers. John Kelly Marc Kennis Stuart Roberts John Keith Paul Kasian Deborah Neff Cheri Walker #atomo #atomodiagnostics #hiv #hivaids #hivtests #hivtestkits #hivtests #selftesting #medtech #medtechstocks #healthcare #healthcarestocks #stocks #shares #equities #investing #investors #equitymarkets #sharemarket #stockmarket #asx #asxstocks #asxshares  

ICYMI: Atomo CEO John Kelly presented Atomo Diagnostics' Q2 FY25 update on Thursday, January 30. To watch the replay of the webinar, click the link below. https://lnkd.in/gjMT5rEa

This coming week from February 3-5, Atomo CEO John Kelly will be heading over to Dubai for the annual Informa Markets #Medlab Middle East Summit. Medlab Middle East is the leading laboratory and diagnostics exhibition and conference in the Middle East, bringing together global experts, industry leaders, and innovative companies in the field of medical laboratory technology. Held annually in Dubai, UAE, Medlab serves as a hub for professionals in clinical diagnostics, laboratory management, and medical research. The event features a large-scale exhibition showcasing cutting-edge diagnostic equipment, laboratory instruments, and healthcare solutions from top manufacturers and suppliers worldwide. It also hosts a multi-track conference program, offering deep insights into laboratory medicine, digital pathology, molecular diagnostics, and regulatory advancements. Medlab Middle East attracts a diverse audience, including laboratory professionals, healthcare providers, policymakers, and business executives, making it a key platform for networking, business development, and knowledge sharing. It plays a crucial role in advancing laboratory medicine and improving healthcare outcomes across the Middle East and beyond. If you are attending Medlab and would like to meet with John to discuss how Atomo's cutting edge rapid diagnostic solutions can help elevate your organisation's products, please reach out on LinkedIn or email info@atomodiagnostics.com See you in Dubai!

Atomo Diagnostics is pleased to present its results for Q2, FY25.   Chief Executive Officer John Kelly will discuss key highlights from the quarter and provide an overview of the Company's focus for 2025.   The presentation will run for approximately 20 minutes with a 10-minute Q&A session to follow.   Please submit all questions in advance to investorqueries@atomodiagnostics.com    Date: Thursday, 30 January Time: 1:30pm AEDT Duration: Approximately 30 minutes To register for the webinar, click the link below. https://lnkd.in/gEms9CVu

Atomo Diagnostics is pleased to announce the signing of a new long-term supply agreement with existing distributor Newfoundland Diagnostics, valued at approximately AUD 5.44 million over five years. Effective immediately and running through June 30, 2030, this agreement grants Newfoundland exclusive distribution rights for Atomo’s HIV Self-Test in the UK and non-exclusive rights for the EU and Colombia. It also includes an initial order for 50,000 tests, scheduled for production this quarter. Newfoundland has distributed Atomo’s HIV Self-Test under its own branding across the UK and various European countries for over a year. More recently, Newfoundland expanded its reach into Eastern Europe and Colombia under a previous agreement (see ASX Release: June 14, 2023 here: https://lnkd.in/gSRtteNm). The Newfoundland-branded HIV Self-Test has achieved market penetration in the UK, being launched in leading retail chains such as Boots Pharmacies and Tesco Supermarkets. The latest purchase order will support product launches in several Eastern European markets, where rising HIV infection rates continue to drive demand for accessible testing solutions. Atomo CEO John Kelly expressed enthusiasm about the strengthened partnership: "We are excited about building a long-term relationship with Newfoundland. They have done an excellent job getting our HIV tests on the shelves of the leading retailers in UK & Europe and this partnership gives us the perfect channel to launch other Atomo tests, including a novel test for the detection of syphilis infection." Newfoundland CEO Frederick Manduca echoed this sentiment, stating: "Newfoundland are delighted to be continuing our partnership with Atomo Diagnostics. We have had great success distributing the test and working with partners such as the Terrence Higgins Trust and major retailers in the UK. We are excited to continue this success in the coming years by furthering our distribution into new channels and international territories." Read the ASX Announcement here: https://lnkd.in/gsmRHruX

As we approach the end of the year, we’re reflecting on our achievements at Atomo Diagnostics in 2024, starting with our work in domestic HIV self-testing here in Australia. We are proud to have: ✅ Supplied 7,500+ HIV Self Tests to pharmacies across the country ✅ Delivered 26,000+ free HIV Self Tests through NAPWHA's national giveaway program ✅ Provided 3,000+ free HIV Self Tests via vending machine programs facilitated by community organisations It’s been fantastic to see the increasing focus on self-testing, including its emphasis in the Federal Government's 9th National HIV Strategy released in late November. Thank you to our partners, advocates, and communities for helping improve access to HIV testing. Together, we’re making huge strides towards the virtual elimination of HIV in Australia.

Atomo is pleased to note that the Lumos Diagnostics FebriDx® test has received approval from the Centers for Medicare and Medicaid Services (CMS) Panel: PLA code (0442U), with reimbursement set at US$41.38 per test. A PLA code is instrumental in enabling reimbursement from both government and private insurers, and approval marks a pivotal step in improving the accessibility and adoption of FebriDx in the US. Atomo anticipates that reimbursement in the US will drive increased demand for its Pascal cassette, which Lumos utilises to deliver the FebriDx assay to end users.