Company Announcement
Nanoform Finland Plc
February 27, 2025
08:10 a.m. Finnish time / 07:10 a.m. Swedish time
Nanoform 2024 report: Deal discussions around product kernels intensify
After a strong second half, 2024 showed a record number of new projects signed. Revenue growth is back and is expected to continue in coming quarters and years. Other operating income (incl. product kernel milestones) is also expected to grow. Manufacturing of GMP material for pivotal studies and registration batches in Project Nanoenzalutamide has continued in a 3-shift pattern, pivotal studies will start early 2Q25, with first read-out in the same quarter. The dealmaking discussions around our product kernels has intensified and we expect to sign deals on our first three product kernels (Nanoenzalutamide, Nanoapalutamide and Nanoencorafenib) in the coming weeks and months. Company mid-term business targets 2030 to be announced during 2025 in conjunction with Capital Markets Day.
10-12/2024 key financials
1-12/2024 key financials
(Numbers in brackets refer to the corresponding last year reporting period, unless otherwise mentioned.)
* Defined as materials & services expenses, employee benefit expenses, and other operating expenses.
** Including Treasury bills. Part of the cash has been invested in short-term government bond.
CEO's review
Nanoform continues to progress on many fronts. After six quarters of negative revenue growth (1Q23-2Q24), we have seen strong momentum during the last two quarters and we expect this to continue in the coming quarters and years. The growth will be fuelled not only by a growing number of non-GMP projects and GMP projects - both in the small molecules and biologics - but also from development, exclusivity and milestone payments and later on from commercialization fees and royalties related to our technology offerings and product kernels.
During 2024 we signed another yearly record number of new projects, with especially the second part of the year showing strong momentum. I am pleased by the fact that our Biologics technology offering is starting to get the attention it deserves. Another area where we see a lot of attention globally is around our product kernels. The deal negotiations around nanoenzalutamide, nanoapalutamide and nanoencorafenib are progressing well, and we expect to sign deals with development partners and commercialization partners in the coming weeks and months.
Manufacturing of GMP material in project Nanoenzalutamide has been extended into a three shift pattern during 4Q. The scale-up from last year's campaign for the pilot study has been close to 100x in the ongoing manufacturing campaign for the upcoming pivotal studies and registration batches. This is a fantastic achievement by our manufacturing staff! On the R&D side we have again demonstrated a further improvement in the production rate, which lays a path for nanoforming to become a cost leader compared with other technologies in the coming years.
We expect nanoenzalutamide to be the first nanoformed medicine to reach the market - with a planned launch in 2027/28 in the US/EU - and to be an income driver for Nanoform already in the upcoming years. Nanoenzalutamide is expected to progress via the ANDA*/Hybrid generic pathway and as such will need to show bioequivalence vs the originator product, Xtandi®. In the eyes of the regulators, bioequivalence means 80% - 125% of the Cmax and AUC in a large cohort study in fed and fasted states with a 90% confidence interval. * ANDA=Abbreviated New Drug Application
The global annual sales of Xtandi® is presently USD 6bn and growing. We plan for nanoenzalutamide to take a meaningful share of this market through its highly patient centric product differentiation (1 tablet vs 4 tablets) and unique IP position (different technology, crystalline product, different excipients), while not forgetting its green attributes. We see the program to be attractive to value added medicine companies as a uniquely differentiated and high value supergeneric product that can enable a product launch before market entry by other generic products based on the ASD formulation, for which the originator currently holds patents in both Europe and the US (with expiry dates in 2033). For the originator company we believe that the nanocrystalline single tablet product offers a patient centric life cycle extension opportunity with compelling sustainability advantages that would be difficult for generic competitors to match. Avoiding the inherent stability challenges associated with amorphous materials is also a clear benefit for any company considering alternative formulation approaches.
Xtandi-tablets are formulated using a solubility-enhancement spray drying process to create an amorphous solid dispersion. The major challenge with spray drying is that the process often requires large amounts of undesirable and toxic organic solvents. Nanoform's CESS® process uses CO2 of recycled origin, and is organic solvent-free, offering a greener alternative to medicine developers that seek to be both patient- and planet-centric. Nanoform continuously improves the CESS® technology, e.g. by planning to further recycle the CO2 used by the process to become a carbon sink. This is an attractive proposition for the pharma industry to achieve its ambitious net zero goals. There are already concerns in the industry that industrial approaches with a heavy carbon footprint, e.g. spray drying, may lose their relevance in the future because of their environmental burden.
The timelines for the commercial launch of nanoenzalutamide are demanding, but achievable. First, we need to manufacture nanoformed GMP material for the registration batches and the pivotal bioequivalence studies. When positive, the submissions of the dossiers will follow, with the aimed product launch after the expiry of the enzalutamide substance patent in the respective territories (2027/28, US/EU).
During the past year we have worked on more than 40 different customer projects. These cover both small molecules and biologics, and range across multiple therapy areas and delivery methods. I remain encouraged by the diversity of our nanoparticles and nanoformulations. Not all customer projects progress - for a whole host of reasons - but the momentum I see in many of these projects makes me confident that we will also see some of these ongoing customer projects enter the clinic in the upcoming quarters and years. This also serves as testament to our strategy to work with many different companies and APIs, and not become dependent on any single project.
For Nanoform the last years have been about making large investments and building a capable organization. The coming will be about preparing to launch nanoformed products together with partners onto the global markets. We are ready for the challenge. I look forward with confidence and excitement to the coming years. None of this can be done without our amazing employees and great partners. My sincere THANK YOU to you all for your continued dedication to Nanoform and for the inspiring and innovative work for which we're known.
Best Regards,
Prof. Edward Hæggström, CEO Nanoform
Attached to this press release are Nanoform's Financial Statement Review 2024, Report of the Board of Directors and Financial Statements 2024, Corporate Governance Statement 2024, Renumeration Report for Governing Bodies 2024 and Hallituksen Toimintakertomus ja Tilinpäätös tilikaudelta 2024. All these can also be found at: https://nanoform.com/en/media-center/press-releases/
Nanoform online presentation and conference call February 27, 2025, at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time:
The company will hold an online presentation and conference call the same day at 3.00 p.m. Finnish time / 2.00 p.m. Swedish time. Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, CCO Christian Jones and General Counsel/CDO Peter Hänninen. The presentation will be delivered in English.
The presentation will be broadcast live as a webcast available at:
https://nanoform.events.inderes.com/q4-report-2024
Teleconference dial-in numbers:
Dial-in number to the teleconference will be received by registering via the link below. After the registration you will be provided phone numbers and a conference ID to access the conference. Questions can be presented by this dial-in function.
https://conference.inderes.com/teleconference/?id=5003370
Company near-term business targets for 2025
Company mid-term business targets 2030
Our nanocrystalline alternatives to ASDs (amorphous solid dispersions)
Nanoenzalutamide, Nanoapalutamide, and as the latest addition Nanoencorafenib, are opportunities for us to show that small is a powerful ingredient in formulation. Due to the inherent poor solubility of the API, the current formulation of these medicines has been an amorphous solid dispersion ("ASD"). Amorphous API materials are unstable, and therefore require high amounts of polymers to stabilize the API - leading to a low drug load in the product and therefore, in the case of oral solid products, often to a high number of large tablets that need to be taken by the patient. This is a known problem, in particular for patient populations with challenges to swallow. The nanocrystalline formulations developed by Nanoform offer an attractive alternative with a substantially higher drug load in the final drug product and consequently a reduced tablet burden for the patient.
In Project Nanoenzalutamide, the manufacturing of the nanoformed drug substance for the pivotal study has progressed well and we have delivered already in excess of 50kg of material to our partner. We expect the clinical study to start in early 2Q 2025, with first read-out in late 2Q 2025. Project Nanoapalutamide is also progressing to plan. Following the positive results from the in vivo study comparing Nanoform's tablet prototypes with the currently marketed product, we have continued with the tablet development activities and are actively preparing GMP manufacturing activities and the pilot PK study in humans, which we expect to take place still in 2025.
We remain encouraged by the broad interest shown for these patient centric reformulations in key markets (among them US, Europe, and Japan) and are in ongoing discussions for all three products with potential development and commercialization partners. We expect to sign deals around these product opportunities during the coming weeks and months.
In addition to the patient benefit, we can with our proprietary technology offer opportunities to extend IP protection for the reformulated and improved product, expecting that in many cases our innovative formulations will be patentable. Importantly, current ASD based medicines are often protected by secondary patents that claim aspects of the ASD formulation. These secondary patents, such as in the case of the product in Project Nanoenzalutamide, often extend by several years the expiration of the primary patent claiming the API. In the case of Project Nanoenzalutamide, we believe that our nanocrystalline formulation is not in the scope of the patents claiming the ASD formulation. This should potentially enable entry earlier into the market, in the jurisdictions where the ASD formulation patents remain active, compared to ASD based generic formulations.
ASDs remain a leading formulation strategy for poorly soluble APIs, particularly for oral solid dosage forms. There are currently some 50 marketed medicines that are ASDs and these sell in aggregate for some USD 50bn annually in the world. We continue to actively look at several other opportunities in this field from products both in the market and in the global drug development pipeline. According to STARMAP®, almost 80 per cent of the 46 ASDs we so far have starmapped may be well suited to be nanoformed by CESS®.
Significant events during 1-12/2024
[3] Erleada is a registered trademark for Apalutamide owned by Johnson & Johnson / Janssen Biotech Inc.
For further information, please contact:
Albert Hæggström, CFO
albert.haeggstrom@nanoform.com / +358 40 161 4191
For investor relations queries, please contact:
Henri von Haartman, Director of Investor Relations
hvh@nanoform.com / +46 7686 650 11
About Nanoform
Nanoform is the medicine performance-enhancing company that leverages best-in-class innovative nanoparticle engineering technologies, expert formulation, and scalable GMP API manufacturing to enable superior medicines for patients. The company focuses on reducing clinical attrition and on enhancing drug molecules' performance through its nanoforming technologies and formulation services, from pre-formulation to commercial scale. Nanoform will help improve bioavailability and drug delivery profiles, drive differentiation, patient adherence and extend the lifecycle potential of products. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki (ticker: NANOFH) and Stockholm (ticker: NANOFS). Certified Adviser: Carnegie Investment Bank AB (publ), +46 8-588 68 570. For more information, please visit www.nanoform.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements regarding Nanoform's strategy, business plans and focus. The words "may", "will", "could", "would", "should", "expect", "plan", "anticipate", "intend", believe", "estimate", "predict", "project", "potential", "continue", "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Nanoform's business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other companies, and other risks described in the Report of the Board of Directors and Financial Statements for the year ended December 31, 2024 as well as our other past disclosures. Nanoform cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Nanoform disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent Nanoform's views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.