Company Announcement
Nanoform 1-12/2020 report and new company near-term target introduced
First GMP manufacturing campaign and first dosing in humans successfully completed, positive interim results from first clinical study announced, all near-term business targets set out in IPO achieved, ten new Small Molecule PoC projects started, four more non-GMP lines commissioned, first Biologics PoC project commenced and a new near-term business target introduced: "At least 3 new non-GMP lines in 2021 and 2 new GMP lines in 2022".
10-12/2020 key financials:
- Revenue was
- The gross profit and margin came in at
- The operating loss was
- The loss for the period was
- Basic EPS was
- The number of employees grew to 74 at the end of 2020 (43 employees at the end of 2019).
- Cash position was
1-12/2020 key financials:
- Revenue was
- The gross profit and margin came in at
- The operating loss and the loss for the period were both
- Basic EPS was
-
Significant events during 1-12/2020
- In
- In March Nanoform signed two new agreements, one with a global major pharma company and one with
- In March two new non-GMP lines were commissioned.
- On
- In April Nanoform was awarded Good Manufacturing Practice (GMP) certification by the
-In April the Company's form was changed to a public limited liability company and the share capital was increased to
- Early June,
- In June a Proof of Concept contract was signed with a
- In June Nanoform expanded its US commercial team by appointing
- During 4-6/2020 a new non-GMP line was commissioned, taking the capacity to seven non-GMP lines and one GMP line on the small molecules side.
- In June Nanoform appointed
- In July Nanoform's near-term business target to acquire more new customers in 2020 than in 2019 was achieved, when Nanoform signed a contract with a West Coast US Biotech company.
-
- In September, a new global major pharma customer was signed.
- In October, a major milestone and mid-term business target was achieved when Nanoform announced that it had initiated its first GMP manufacturing campaign for the first ever human trial of a drug candidate nanoformed using Nanoform's proprietary CESS® technology.
- In October
- In November, a new non-GMP line (nr 8) was commissioned.
- In November, Nanoform launched a new proprietary nanotechnology that can form biological nanoparticles as small as 50 nm and announced a new near-term business target for 2021: "To deliver its first biologics Proof of Concept project for this new technology with a pharmaceutical or biotech partner".
- In December, Nanoform announced that twelve healthy volunteers had - at Quotient Sciences' facilities in
- In December,
Significant events after 10-12/2020
- Early January, a new near-term business target was announced: "At least 12 new non-GMP and at least one GMP customer project in 2021".
- In January, Nanoform announced positive interim results from its clinical study. The interim results obtained from the ongoing clinical trial, suggest that a nanoformed oral piroxicam tablet achieved significantly faster absorption when compared to the reference tablet from the originator
- In February,
- In February, a PoC agreement was signed with an
- On
CEO's review
2020 - What a year!
When we late in 2019 kicked off the IPO project at the same time as we worked on building our first GMP manufacturing line, none of us foresaw the COVID-19 pandemic, that still today is strongly present in our lives. It's therefore with immense pride I look back at everything our group of Nanoformers achieved last year. The many things we accomplished in parallel work streams were astonishing.
In April we got GMP certification, followed by the first GMP manufacturing campaign in October, which was then followed by the successful first dosing of nanoformed drug material in humans in December. All three steps were achieved ahead of schedule, on the first attempt, and within budget, which shows the quality, spirit, and dedication of our R&D, Manufacturing, Business Operations, QC, and QA teams.
We more than doubled our line capacity on the small molecule side, from four non-GMP lines to eight non-GMP lines and one GMP line. On the Biologics side, we added our first two non-GMP lines, which are ready to be commissioned when the first client projects start. Here again we saw tremendous co-operation and execution from our R&D (Small molecules & Biologics teams), Manufacturing and Business Operations teams.
Our commercial team, which doubled in size, brought in five times more customer projects during the year, which kept everybody busy, including the Project Management team. This was done during a year when travel was very restricted, which made the achievement even more impressive. The team, together with our IT team, conceptualized and created a virtual tour where present and prospective clients and partners can effectively visit our facilities! This has been much appreciated as an environmentally friendly and time efficient way to visit our facilities, meet our personnel at their posts, and see our nanoforming lines in action, - of course spiced up with the ability to interactively ask questions and discuss in a live setting.
All this was achieved during a year when we became a publicly traded dual-listed company. Here the Finance team really showed their determination, flexibility and will to execute while building new operational processes.
I look with confidence and excitement forward to the coming years. We'll continue to work relentlessly towards our 2025 mid-term business targets, with our near-term business targets being "at least 12 new non-GMP customer projects and at least one new GMP customer project in 2021" and "at least 3 new non-GMP lines in 2021 and 2 new GMP lines in 2022". We already in February achieved our near-term business target "First commercial Biologics PoC project signed in 2021".
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 are known. Our journey has begun, let's make the next five years as exciting and fast paced as the first five ones have been!
Best Regards,
Prof. Edward Hæggström, CEO Nanoform
Company near-term business targets for 2021 and 2022
· First Biologics PoC project in 2021 (achieved in February)
· At least 12 new non-GMP and at least one GMP customer projects in 2021
· At least 3 new non-GMP lines in 2021 and 2 new GMP lines in 2022 (new target)
Company mid-term business targets 2025 (unchanged)
· to nanoform at least 50 new Active Pharmaceutical Ingredients (API) annually
· to have in place 25 operating production lines of which 5 to 10 are expected to be GMP production lines
· over 90 percent gross margin
· approximately 200 employees
· to be cash flow positive
Nanoform's complete 1-12/2020 report can also be found at: https://nanoform.com/en/financial-reports-and-presentations/
Nanoform 1-12/2020 report Conference Call and online presentation
Nanoform will be represented by CEO
The presentation will be broadcast live as a webcast available at: https://financialhearings.com/event/13593
Teleconference dial-in numbers:
In conjunction with the approval of the Report of the Board of Directors and Financial Statements for the Year Ended
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 specified in Nanoform's prospectus published (on
https://news.cision.com/nanoform/r/nanoform-1-12-2020-report-and-new-company-near-term-target-introduced,c3296338
https://mb.cision.com/Main/18905/3296338/1379318.pdf
https://mb.cision.com/Public/18905/3296338/8aec8b43a93f2d1f.pdf
https://mb.cision.com/Public/18905/3296338/9a91c06aabf1d6d3.pdf
https://mb.cision.com/Public/18905/3296338/818238f68ceb501e.pdf
https://mb.cision.com/Public/18905/3296338/b505c26270d7d618.pdf
https://mb.cision.com/Public/18905/3296338/8cb06732d47b83fa.pdf
(c) 2021 Cision. All rights reserved., source