BUSINESS: Nanoform Interim Report January – September 2021

dWeb.News Article from Daniel Webster dWeb.News

by Daniel Webster, dWeb.News Publisher

HELSINKI, Nov. 25, 2021 /PRNewswire/ — The strong momentum continues: all near-term business targets for 2021 achieved, rapid customer project intake accelerating, commercial team in Europe expanded, more line capacity added, ISMS certificate received, and a new near-term business target introduced: “Biologics pilot line for GMP in 2022″.

7-9/2021 key financials:

– Revenue came in at EUR 0. 48 million, up 198 % compared with EUR 0. 16 million in 7-9/2020.

The gross margin more than quadrupled to EUR 0. 42 million as the gross margin jumped to 88% (EUR 0. 10 million, 63% in 7-9/2020).

– EBITDA was at EUR 4. 62 million (EUR -3. 49 million).

The operating profit was EUR 5. 11 million (EUR -3. 81 million).

The period’s loss was EUR 4. 51 million (EUR -4. 16 million).

– Basic HTML EPS was EUR 0. 06 (EUR -0.06).

– The number of employees grew to 116 at the end of the review period (68).

– Cash position was EUR 82.4 million on September 30, 2021 (EUR 66.6 million).

1-9/2021 key financials:

– Revenue EUR 1. 30 million, growth + 159%, stemming from 18 different customer projects (EUR 0. 50 million, 9 customer projects in 1-9/2020).

The gross margin more than tripled to EUR 1 18 million as the gross margin jumped to 91% (EUR 0. 36 million, 72% in 1-9/2020).

– EBITDA came in at EUR -12. 90 million (EUR -13. 97 million).

– The operating loss improved to EUR -14. 31 million (EUR -14. 79 million).

– The loss for the period improved to EUR -14. 12 million (EUR -15. 50 million).

– Basic HTML EPS was EUR 0. 21 (EUR -0.29).

EUR 40 million (gross) was raised in a new share issue in March.

( Numbers in brackets refers to the last year reporting period. )

Significant events during 1-9/2021

– 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”.

– Nanoform released positive interim results from its clinical trial in January. Nanoform’s interim results showed that the oral piroxicam tablet was significantly more absorbable than the reference tablet from Pfizer.

– A Biologics Proof-of-Concept Agreement was signed by Nanoform and Herantis Pharma Plc in February. It aims to improve nasal drug delivery to Herantis’ CDNF treatments for Parkinson’s disease with Nanoform’s biological nanoparticle technology. As a result, Nanoform achieved its near-term business target of “First Biologics PoC project signed in 2021”.

– A PoC agreement was concluded with an East Coast US Biotech Company.

– Nanoform released positive interim results from its clinical trial in February. Nanoforming may offer viable alternatives to more complex formulations such as cyclodextrin-based technologies, based on the fast absorption data.

– Nanoform named Dr Jamie Unwin to be its Commercial Insights Officer. He will be based in Oxford UK , and will begin in April.

– On February 26, a new near-term business target was announced: “At least three new non-GMP lines in 2021 and two new GMP lines in 2022”.

– In March, Nanoform and Nacuity Pharmaceuticals, a Texas-based clinical stage pharmaceutical company, signed a technology Proof of Concept agreement to enhance ophthalmic drug delivery of Nacuity’s NPI-001 and NPI-002 drug candidates.

– A PoC agreement was also signed with an European Biotech Company.

– In March, Nanoform launched the next generation of its STARMAP(r) artificial intelligence platform, v2.0. The technology utilizes sparse-data AI to augment experimental results from its CESS(r) nanoparticle engineering process with detailed expert knowledge, allowing reliable predictions to be made regarding partners’ potential success of nanoforming their drug molecules. STARMAP(r) is a digital version of the CESS(r) technology that enables in silico experiments in large quantities, creating fast predictions of which molecules should be nanoformed.

– In March, EUR 40 million (gross) was raised in a successful new share issue through an accelerated bookbuilding process. Strong interest was shown by international and Nordic investors. This capital raise, which was significantly oversubscribed, attracted a significant number of institutional investors from Tier 1 countries.

– Nanoform named Dr Christopher Worral VP Business Development US in March. He was based in San Diego , and began his tenure in May.

– During 1-3/2021 three new non-GMP lines were commissioned. As a result, the near-term business target “at least three new non-GMP lines in 2021”, was achieved.

– At the AGM Miguel Calado , presided over the Board of Directors.

In April Nanoform and Aprecia (a US-based 3D printing pharmaceutical company) announced they were exploring synergies in the field 3DP dosage forms. This collaboration will combine Nanoform’s nanoformed particles for fast dissolution with Aprecia’s ZipDose platform for rapid disintegration. It will enable high-performance buccal and oral delivery to patients who require rapid absorption.

– Nanoform announced in May that it had completed and published the final results of its clinical trial. All of the primary, secondary, and optional exploratory goals of the study were met. Nanoform’s CESS (r) technology was able to develop a fast-acting piroxicam instant release tablet formulation that is more absorbable and delivers the drug faster than a standard reference IR tablet. The study results confirmed the previously published interim results. They also support the clinical utility and potential application of Nanoform’s technology for fast-acting dosage forms for low-soluble drugs.

In May Nanoform and a US-listed metabolic pharmaceuticals company entered into a collaboration agreement.

In May Nanoform and Celanese Corporation announced plans to examine the synergies among their respective technologies in nanoparticle-enabled drugs delivery. The goal is to assess the utility of combining Nanoform’s nanoparticle platform technologies with Celanese’s VitalDose(r) EVA copolymer delivery technology for drug-eluting implants. These are the goals of next-generation drug delivery systems that can support higher drug loads and have enhanced sustained release properties. Nanoform and Celanese will collaborate on formulation development to take advantage of each other’s specific formulation expertise.

In May, a PoC agreement was signed with a US Biotech firm.

– On June 2, Nanoform raised its mid-term business targets for 2025. The new targets are:

To nanoform annually at least 70 new active pharmaceutical ingredients, or `APIs’ (40% increase from the previous target of at least 50 new APIs annually)
To have in place 35 operating production lines, of which 7 to 14 are expected to be GMP compliant (40% increase from the previous target of 25 operating lines of which 5-10 are GMP compliant)
To have 200-250 employees (0-25% increase from the previous target of ~200)
To have a gross margin over 90 percent (unchanged; re-iterated)
To be cash flow positive (unchanged; re-iterated)

The raised midterm business targets were a consequence of several factors: the additional market opportunity foreseen for Nanoform’s new biologics technology, the significant interest in Nanoform’s service offering shown by the global pharma market, and the fact that both the number of companies developing novel drugs and the total number of APIs in the global pipeline continue to grow rapidly. In June, an international European company signed a letter of intent to develop, manufacture, and commercialize a nanoforming enhanced version of a blockbuster drug. Patients will benefit from the expected improvements. Nanoform has begun a PoC study of the asset, which was paid for by the partner. They are also in discussions to execute the definitive agreement for further co-development, GMP manufacturing, and other matters. The final agreement will only be executed if the PoC study is completed and the agreement on standard contractual terms with the partner.

– A PoC contract was signed in July with a global major pharma client.

– In August, Boehringer Ingelheim signed a Master Services Agreement. Proof of Concept studies may now be performed to assess the added value Nanoform’s CESS(r) technology can deliver to Boehringer Ingelheim’s drug development projects.

In August, a fourth PoC was initiated with a major global pharma customer.

– Herantis Pharma Plc reported successful results from its collaboration with Nanoform. The project aims to improve nasal drug delivery to Herantis’ CDNF treatments for Parkinson’s disease using Nanoform’s biological nanoparticle technology. The PoC project demonstrated that nanoforming was successful in rhCDNF. rhCDNF protein remained stable during the nanoparticle-forming process. It retained its structure, function and neuroprotective effects, in accordance with CDNF controls.

– Nanoform named Dr Nathalie Huffer VP Business Development Europe in September. She was based in the UK and began her tenure in November.

– Nanoform signed a contract in September for the implementation a new enterprise resource management system. The ERP system will be based on SAP’s S/4HANA solution and Nanoform’s partners in the implementation will be NTT Data Business Solutions, a leading global business and IT services provider with significant experience from the pharmaceutical industry as well as Enfo, a highly experienced Nordic SAP partner headquartered in Finland.

– In September, Nanoform announced that PoC studies will be funded by the Bill & Melinda Gates Foundation to assess the added value Nanoform’s CESS(r) nanoparticle engineering technology can deliver to several of the foundation’s drug development projects.

Significant events after 1-9/2021

– On November 12, Nanoform announced that it had received ISO/IEC 27001: 2013 certification for its Information Security Management System (ISMS). All information, systems and processes that store, process, or handle trusted data for Nanoform and its clients are covered by the ISMS.

– On November 15, Nanoform announced that it had signed a GMP agreement with a European headquartered international company and that as six new non-GMP projects were signed in the third quarter, the near-term business target “At least 12 new non-GMP and at least one GMP customer project in 2021” was achieved.

– On November 17, Jeanne Thoma was appointed ordinary member of the Board of Directors at the EGM.

– On November 25, a new near-term business target was announced: “Biologics pilot line for GMP in 2022”.

CEO’s review

More than two dozen customer PoC projects started during the last two years – next on the growth journey I expect multiple customer GMP projects on multiple GMP lines!

Nanoform has continued to execute strongly. While we have signed our first GMP customer contract, we also won many non-GMP projects with repeat and new customers. We have continued to implement our GMP capacity expansion plan as planned and continue to attract top-notch new employees from around the globe. Special effort has gone into expanding the GMP manufacturing staff, where we’ve introduced a shift work structure to be ready to serve significant customer interest and the two new GMP lines that will become operational during 2022. This will triple our GMP capacity to manufacture small molecules. In the Biologics domain we expect the pilot line for GMP to be ready in 2022.

During 2019-2021 we’ve diligently crafted GMP capability – hardware, software, and best practices by skilled operators – all part of the big, thoroughly regulated puzzle that takes time and significant investments to achieve. We currently have twenty nanoformers in our GMP manufacturing organisation. This number is expected to increase rapidly over the next few years. As the number of customer-APIs we’ve initiated PoC work on already exceeds two dozen – and should increase at least by 10x to more than 200 by 2025 – it is imperative that we build and polish our skills, processes, and most importantly quality as early as possible. We have done a fantastic job and we are now ready to take a logarithmic leap in GMP manufacturing.

We are ready for a similar logarithmic leap in our IT systems. After thoroughly reviewing five global ERP vendors and their IT partners, we selected SAP’s private cloud solution S/4HANA with highly experienced SAP partners NTT Data Business Solutions & Enfo as system integrations. SAP is the preferred solution for much of the pharmaceutical sector. This will enable Nanoform to implement many best practices in the industry while also aligning with the systems and working methods of many of Nanoform’s large pharma clients. A great early achievement was the ISO 27001 project, where we received the ISMS certificate a few weeks ago.

All in all, during the last months we’ve continued to expand and polish the different parts of Nanoform (R&D, non-GMP, GMP, pharma development, QC, QA, legal, finance, procurement, HR, IT, business development), continued to win more projects, sign new clients, add exceptional new Nanoformers and set a new near-term business target for 2022, after already having achieved all goals set for 2021. Based on all this action in combination with client interaction, sales pipeline, and our recently strengthened commercial teams in the US and Europe, I’m confident that the coming quarters and years will continue to show strong commercial momentum.

Without our incredible employees and partners, none of these things could have been possible. Thank you to all of our partners and employees for their dedication to Nanoform.

Best Regards,

Prof. Edward Haeggstrom, CEO Nanoform

Company near-term business targets for 2021 and 2022

First Biologics PoC project in 2021 (achieved in February)
At least three new non-GMP lines in 2021 (achieved in March)
At least 12 new non-GMP and at least one GMP customer projects in 2021 (achieved in November)
Two new GMP lines in 2022
Biologics pilot line for GMP in 2022 (new)

Company mid-term business targets 2025 (raised on June 2)

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

Nanoform’s complete 1-9/2021 Interim Report can also be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform 1-9/2021 Interim Report conference call and online presentation November 25, 2021, at 3: 00 p.m. Helsinki time / 2: 00 p.m. Stockholm time

Nanoform Finland Plc (“Nanoform”), will publish its Q3/2021 report on November 25, 2021, at 8. 10 a.m. Finnish time / 7. 10 a.m. Swedish time.

The company will host a conference call as well as an online presentation at the same time on Wednesday, March 3. 00 p.m. Finnish time / 2. 00 p.m. Swedish time. Nanoform’s CEO Edward Haeggstrom, Albert Haeggstrom (CFO), and Christian Jones (CCO) will represent the company. 10 17 26Hen, Director of Investor Relations29.

The presentation will be broadcast live as a webcast available at:

https://financialhearings.com/event/13596

Teleconference dial-in numbers:

Finland: +358931583775

Sweden: +46856642704

Norway: +4723963938

Denmark: +4578150108

United Kingdom: +443333009034

United States: +16467224956

For further information, please contact:

Albert Haeggstrom, CFO
[email protected] / +358 29 370 0150

For investor relations queries, please contact:
Henri von Haartman, Director of Investor Relations
[email protected] / +46 7686 650 11

About Nanoform

Nanoform is an innovative nanoparticle medicine enabling company. 744 81 968 3854908 331 Nanoform’s formulation services and nanoforming technologies are used to reduce clinical attrition. Nanoform’s capabilities include GMP Manufacturing. Its services cover the small to large molecule space. The company’s focus is on key issues in drug solubility, bioavailability, and enabling new drug delivery applications. 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: Danske Bank A/S, Finland Branch, +358 40 744 1900. 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. These words are intended to identify forward looking statements. 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 May 22, 2020) in connection with Nanoform’s initial public offering (the “Prospectus”) under “Risk Factors” and in our other filings or documents furnished to the Finnish Financial Supervisory Authority in connection with the Prospectus. You should not place undue trust in any forward-looking statements. These statements are only accurate as of the date made. Nanoform does not have any obligation to update or revise forward-looking statements in order to reflect any changes in expectations, events, conditions, or circumstances. Actual results may differ from those stated in these statements. Forward-looking statements in this press release are only accurate as of the date they were made and should not be regarded as an indication of future results.

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SOURCE Nanoform

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