Company Announcement
Nanoform Q3 and 9M 2022 report: Continued solid progress
Highly promising in-vivo data for the treatment of glioblastoma multiforme presented with TargTex, new collaboration agreement signed with European consortium, first runs completed on both GMP line 2 and Biologics pilot line for GMP, work to find a manufacturing site in the US progressed well, while macroeconomic turbulence now present in talks with some smaller biotech companies. Q3 revenue growth of 79% combined with operating costs down 1% compared with a year ago led to smallest EBITDA loss since 1Q21. Productivity gains and economies of scale will enable continued slow growth in costs while expanding our manufacturing capacity and customer base.
7-9/2022 key financials:
- Revenue grew by 79% to
- The gross profit nearly doubled to
- EBITDA improved to
- The operating loss improved to
- The loss for the period was
- Basic EPS was
- Cash position was
1-9/2022 key financials:
-Revenue grew by 92% to
-The gross profit almost doubled, from
- The number of employees grew by 23 % to 143 (116) compared with one year ago.
- The total operating costs* grew by 18 % to
- EBITDA came in at
- The operating loss was
- The loss for the period was
- Basic EPS was
-
(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
Significant events during 1-9/2022
- On
- In March,
- On
Security and safety - the interface has been developed in alignment with ISO27001:2017 standards.
Client submissions are seen only by clients (not by Nanoform), allowing molecules to be screened without sharing structures. Outputs are presented directly to the client via the system.
Scalability and agility: The ability to manage thousands of molecules in a single submission to support the selection of candidates from molecule libraries is possible.
Novel insights: STARMAP® Online holds a database of over 17,000 pre-analyzed, public-domain disclosed drugs and candidates. Clients can request thematic evaluations and understand the power of CESS® in different therapeutic areas, target classes, and disease areas.
- During Q2
- In July, Nanoform announced that it has partnered with Pharmanovia, a fast-growing specialty pharma business with a portfolio of over 20 branded drugs in 140 markets. The new strategic partnership aims to add value to branded prescription medicines. Pharmanovia will look to apply Nanoform's proprietary nanoparticle technologies and formulation know-how to leading established pharmaceutical brands. The partnership starts with an iconic branded medicine where both parties see value in enhancing bioavailability for patient benefit. The value of the stage-gated agreement is according to Nanoform's business model for non-GMP and cGMP work.
- During 1-9/2022 fifteen (15) new non-GMP projects were signed, with more than a dozen customers, both new and repeat customers, both US and
Significant events after 1-9/2022
- On
The data was generated for a planned Phase 1/2a clinical trial, due to commence in early 2024. Nanoform will deliver GMP grade nanoformed material to TargTex for the clinical trial. The drug is a selective Ca2+ channel blocker delivered by implantation at the site of the resected tumor in the brain. Nanoform and TargTex have collaborated in the optimization of a hydrogel formulation enabled by nanoformulation of the drug.
The study was conducted in a rat model for GBM in which tumor cells are injected into the brain. After 2-3 weeks, the nanoformulated hydrogel was delivered locally in the brain of the animal, on top of the tumor. The study results showed long term survival of 40 per cent of the treated animals and no microscopic tumor cells were detected in these animals at sacrifice.
The nanoformed drug product provided a controlled release and deep drug diffusion across the brain parenchyma. The data showed no systemic exposure, and the drug was not toxic at maximum loading concentration. The study was performed at a sub-therapeutic dose that can be increased by at least 2-fold. Future studies are planned to be performed at increased drug concentrations with the goal to further improve long term survival.
- Nanoform previously disclosed on
- In November, Nanoform filed to FIMEA a notification of an update to our manufacturer's authorization. This relates to additional API and manufacturing lines.
CEO's review
Another quarter of solid progress at Nanoform, despite the ongoing macroeconomic turbulence. We've continued to invest in and execute on our main tasks; client relationships & brand recognition, line capacity, IT & automation, processes, facilities, preparing for the US and the ability to help our clients generate positive data in biology, with the ultimate goal to help patients. Not forgetting our main 2025 target of becoming cashflow positive.
Speaking of biological data and the potential of helping patients in the future, I'm very pleased with the progress we've made with TargTex, where we jointly in
I'm also pleased to announce that after a year of extensive preclinical work with a European headquartered international company, two privately held European pharmaceutical development and manufacturing organizations have decided to join the drug development program. Together with Nanoform, the four parties will in equal shares fund the development and commercialization of a more patient centric version of a current blockbuster drug.
Related to our substantial ongoing investments, I am happy to inform you that we have completed the first runs on both our GMP2 line and on our Biologics pilot line for GMP. The clean room for GMP3 line is finished and the line equipment and main isolator have arrived. Our ERP project, evident in the IT costs during 2022, has progressed well and we will go live with SAP after closing the books for this financial year.
Our preparation for GMP manufacturing in the US has progressed well during the last months. After dozens of meetings with state representatives - including one governor, municipalities, real estate companies, developers, advisors, and life science companies that have set up manufacturing in different parts of the US, we have now chosen a leading diversified professional services and investment management company, to help us find and establish the manufacturing site in the US.
About the macroeconomic situation. There are many headwinds impacting the global economy; the war in
All in all, I look with confidence and excitement forward to the coming quarters and years. We'll continue to work relentlessly towards our 2025 mid-term business targets, while executing as fast as possible on our near-term targets. 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
Nanoform's complete Q3 and 9M 2022 report can also be found at: https://nanoform.com/en/financial-reports-and-presentations/
Nanoform online presentation and conference call
The presentation will be broadcast live as a webcast available at:
https://financialhearings.com/event/44325
Teleconference dial-in numbers:
FI: +358923195172
SE: +46856642693
NO: +4723500236
DK: +4578723252
DE: +496913803452
FR: +33170750737
US: +16467224903
Company near-term business targets for 2022
- 2 new GMP lines (announced Feb-21)
- Biologics pilot line for GMP (announced Nov-21)
- At least 20 new customer non-GMP projects (announced Jan-22)
- At least 3 new customer GMP projects (announced Jan-22)
Company mid-term business targets 2025
- To nanoform at least 70 new Active Pharmaceutical Ingredients (API) annually
- To have in place 35 operating production lines of which 7 to 14 are expected to be GMP production lines
- Over 90 percent gross margin
- To have 200-250 employees
- To be cash flow positive
For further information, please contact:
Albert Hæggström, CFO
albert.haeggstrom@nanoform.com / +358 29 370 0150
For investor relations queries, please contact:
hvh@nanoform.com / +46 7686 650 11
About Nanoform
Nanoform is an innovative nanoparticle medicine enabling company. Nanoform works together with pharma and biotech partners globally to provide hope for patients in developing new and improved medicines utilizing Nanoform's platform technologies. The company focuses on reducing clinical attrition and on enhancing drug molecules' performance through its Nanoforming technologies and formulation services. Nanoform's capabilities include GMP manufacturing, and its services span the small to large molecule development space with a focus on solving key issues in drug solubility and bioavailability and on enabling novel drug delivery applications. Nanoform's shares are listed on the Premier-segment of Nasdaq First North Growth Market in
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
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