reports
- Sean Conroy
AFT Pharmaceuticals - Expanded R&D pipeline to fuel LT growth
While AFT continues to gain commercial traction from Maxigesic/ Combogesic IV sales in the US (launched by partner Hikma in Q1 CY24) and anticipates the launch of Crystaderm in China, a strong R&D pipeline is central to AFT’s long-term growth ambitions. AFT recently announced the seventh addition to its R&D portfolio, a non-invasive topical alternative treatment for keloid and hypertrophic scarring, addressing the limited treatment algorithm for keloid scars (raised, thickened scars). This devel...
- Sean Conroy
AFT Pharmaceuticals - Poised for international market expansion
AFT continues to focus on expanding its product portfolio and broadening its geographical footprint (including increased investments in its affiliates), which we expect to translate into stronger market traction and an increased top-line for AFT over the medium term. The company has updated the market on its international growth efforts, announcing new manufacturing agreements for Maxigesic Rapid and Crystaderm (ahead of their expected launches in the US and Chinese markets, respectively) and pa...
- Sean Conroy
AFT Pharmaceuticals - US milestone triggers upside and guidance bump
AFT Pharmaceuticals has announced the first sale of its intravenous pain relief medicine, Maxigesic IV, through its US licensing partner, Hikma Pharmaceuticals, a material milestone for AFT’s portfolio expansion and geographic diversification. The NZ$6m milestone payment triggered a bump in FY24 operating profit guidance to NZ$23–25m (from NZ$22–24m previously). The upside was partially offset by slower than anticipated sales traction in Australasia. We adjust our FY24 and FY25 estimates to refl...
- Sean Conroy
AFT Pharmaceuticals - US maiden voyage with Maxigesic IV launch
AFT Pharmaceuticals has announced the launch of Maxigesic IV, an intravenous form of its flagship pain relief prescription medicine, in the US market by licensing partner Hikma, under the brand name Combogesic IV. This is a major milestone given the market size (largest analgesic market, estimated at c US$7bn) and strategic importance in supporting management’s international growth plans. Commercial sales following the launch will trigger a milestone payment of US$6m from Hikma (65:35% split bet...
- Sean Conroy
AFT Pharmaceuticals - Another R&D asset in the bag
AFT Pharmaceuticals has announced the addition of another candidate, HY-091, to its R&D pipeline, for the management of vulvar lichen sclerosus (VLS), a skin condition with no curative treatments available. We note that HY-091 is one of the three R&D assets under diligence by AFT, with evaluation ongoing in another two. An active R&D pipeline is a key focus area for AFT, which will support management’s objective to expand its global footprint and achieve its long-term goal to have international ...
- Sean Conroy
AFT Pharmaceuticals - R&D pipeline strengthens with new candidate
AFT Pharmaceuticals has bolstered its R&D pipeline with the addition of a new product candidate, HY-090, a locally acting novel molecule, targeting Burning Mouth Syndrome (BMS), a condition with no curative treatments. AFT will be developing the asset in collaboration with Hyloris Pharmaceuticals (existing development partner for Maxigesic IV). While Hyloris will be responsible for product formulation, manufacturing and commercialisation in Europe, AFT will take care of clinical trials and relat...
- Sean Conroy
AFT Pharmaceuticals - Global growth despite tough macro environment
AFT Pharmaceuticals reported solid H124 top-line growth, driven by strong momentum in the Asian and international markets. H124 revenues of NZ$83.6m grew 27.2% from H123, bolstered by 171.4% and 47.8% y o y growth in international and Asian markets. Although margins came in softer than expected (operating margin of 3.9% vs 5.3% in H123) with increased upfront launch, marketing and R&D spending, particularly in the domestic ANZ markets, management expects margins to recover in H2 as the business ...
- Sean Conroy
AFT Pharmaceuticals - FDA nod for opioid alternative, upside anticipat...
AFT Pharmaceuticals announced FDA approval for Maxigesic IV, an intravenous form of its flagship pain relief prescription medicine. The FDA approval of the post-operative pain alternative to opioids marks a material win for AFT, given the US is the largest analgesic market (estimated at nearly $7bn) and the current US regulatory hurdles in addressing pain in light of the opioid abuse epidemic. The launch at end FY24 or early FY25 is anticipated to trigger a US$6m milestone payment from Hikma Pha...
- Sean Conroy
AFT Pharmaceuticals - AFTO judgment clears AFT of breach claim
AFT Pharmaceuticals has reported that the Auckland High Court has cleared it of the contractual breach claim filed by PBL Solutions in April 2020, which maintained that the opportunity for Pascomer (a topical formulation of rapamycin) was not under the scope of AFT Orphan Pharmaceuticals’ (AFTO’s) business in its legal case. While the ruling dismissed PBL’s claim for a lump sum payment for the assessed present value of Pascomer’s potential, the legal authority has directed AFT to share 35% of th...
- Sean Conroy
AFT Pharmaceuticals - Near-term goals in sight with FY23 momentum
AFT Pharmaceuticals reported another strong fiscal year, capping off three consecutive years of double-digit top-line growth. FY23 revenues of NZ$156.6m grew 20.2% year-on-year. As expected, top-line growth was H2 weighted, with a c 38% sequential improvement in H223 over H123 attributed primarily to new launches in Australia (revenue up c 61% over H123 in the region). Margins, however, were affected by lower licensing income and higher product launch marketing spend (operating margin of 12.6% v...
- Sean Conroy
AFT Pharmaceuticals - Maxigesic IV closer to FDA approval
AFT Pharmaceuticals has announced that the US FDA has allocated a Prescription Drug User Fee Act (PDUFA) date for Maxigesic IV, an intravenous form of its flagship pain relief medicine. The PDUFA date is expected to be the last step in the FDA review process and has been set for 17 October 2023. It follows submission of additional requested data in April 2023 in response to the complete response letter (CRL) received from the FDA in July 2022 (related to queries about certain extractable and lea...
- Sean Conroy
AFT Pharmaceuticals - Maxigesic international momentum continues
AFT Pharmaceuticals (AFT) has announced that it has signed three additional licensing agreements for Maxigesic IV – with Labatec in Switzerland and Pharma Bavaria in Argentina and Paraguay. The product franchise continues its international expansion, with the deals following the recent launches of Maxigesic IV in five European countries. To date (FY23, ending 31 March) AFT’s flagship product, Maxigesic, is available in 61 countries (across all dose forms), up 15 from the prior year. This is marg...
- Sean Conroy
AFT Pharmaceuticals - Big win with Maxigesic Rapid’s FDA nod
AFT Pharmaceuticals (AFT) has announced it has received FDA approval for Maxigesic Rapid tablets, a quick-release version of its flagship Maxigesic product line. Notably, this marks the first regulatory win for AFT in the US (the world’s largest analgesic market), valued at c US$7bn. While AFT awaits Maxigesic IV’s clearance in the US, we expect this approval to help it build initial commercial traction in this high-margin market. The Rapid tablets, a patented combination of paracetamol (325mg) ...
- Sean Conroy
AFT Pharmaceuticals - Portfolio expansion with new in-licensing deal
AFT Pharmaceuticals continues to strengthen its R&D pipeline with the announced in-licensing agreement with Latitude Pharmaceuticals (a US-based contract research organisation) to develop antibiotic eye drops to treat serious eye infections. The formulation is already approved to treat bacterial infections, including those caused by the antibiotic-resistant MRSA bacteria. The IP relates to an aqueous stable formulation of this treatment. Eye care is a key focus for AFT (contributing over 20% of ...
- Sean Conroy
AFT Pharmaceuticals - Maxigesic IV expands into East European markets
AFT Pharmaceuticals has announced an exclusive licensing and distribution agreement for the Maxigesic intravenous (IV) formulation with Salus Pharmaceuticals (a Slovenia-based wholesaler of pharmaceutical products) for nine Eastern European countries across the Balkan and Baltic regions. Maxigesic IV is already registered in five of the nine countries, with launches planned in CY23. AFT will also file registration applications for the remaining countries during the year. Maxigesic IV is register...
- Sean Conroy
AFT Pharmaceuticals - Progressive outlook for CY23
AFT Pharmaceuticals has presented its key CY22 highlights and strategic priorities for CY23 in a letter to investors. In addition to new product launches in its domestic markets, we expect further international market expansion following focused investments across the UK, Europe and China. Maxigesic remains the main commercial driver with plans to launch new variants internationally, including Maxigesic IV in the US, which was unexpectedly delayed due to FDA observations on product packaging. Th...
- Sean Conroy
AFT Pharmaceuticals - H123 focused on portfolio expansion
AFT reported strong post COVID-19 revenue momentum in H123 (NZ$65.8m, 18.4% y-o-y growth), driven by robust organic growth across all regions, supported by new product launches. Sales uptake was boosted by robust demand from both domestic (23.5% growth in Australia, 34.7% in New Zealand) and Asian markets (26.1% growth). However, profits were weighed down (operating margin of 5.3% vs 9.9% in H122) by the delay in the anticipated licensing income from Hikma (c US$6m) and materially higher SG&A ex...
- Sean Conroy
AFT Pharmaceuticals - Further studies for Maxigesic IV’s US nod
AFT Pharmaceuticals announced that, along with partner Hyloris Pharmaceuticals, the company will initiate additional studies to address the FDA queries (raised in July 2022) related to Maxigesic IV’s packaging. The new studies, which aim to generate incremental data on extractable and leachable compounds from the packaging, are expected to commence before end-CY22 with targeted completion by CY23. The company will file for FDA registration after submitting its response. Maxigesic IV has already ...
- Sean Conroy
AFT Pharmaceuticals - Collaboration for developing birthmark medicine
AFT Pharmaceuticals has announced a collaboration and in-licensing agreement with Massey Ventures (the commercialisation arm of Massey University, New Zealand) and Gillies McIndoe Research Institute, New Zealand, to develop a topical treatment for strawberry birthmarks (infantile haemangiomas) in children. The licensing agreement involves the intellectual property (IP) related to initial research on the treatment and is in line with AFT’s strategy to grow its R&D pipeline by investing in new gro...
- Sean Conroy
AFT Pharmaceuticals - Pascomer falls short of FDA mandated threshold
AFT Pharmaceuticals announced that its Pascomer Phase II clinical trial has failed to meet its primary endpoint of a two-point improvement on the Investigator’s Global Assessment (IGA) scale. Pascomer is AFT’s topical rapamycin formulation being evaluated as a treatment of facial angiofibromas (FA) associated with tuberous sclerosis complex (TSC). As a result, AFT’s US development partner and licensee, Timber Pharmaceuticals, has terminated its agreement with the company. Despite this setback, A...
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