Nanoform Interim Report January - June 2021

HELSINKI, Aug. 26, 2021 /PRNewswire/ -- The strong momentum continues: Additional line capacity, more projects, new clients, the number of employees crosses 100, while the gross margin forcefully breaks through 90 per cent. Letter of intent signed for the development, manufacturing, and commercialization of a by nanoforming improved version of a current blockbuster drug.

Q2/2021 key financials:

• Revenue came in at EUR 0.55 million, up 185% compared with EUR 0.19 million in 4-6/2020.
• The gross profit more than tripled to EUR 0.52 million as the gross margin jumped to 95% (EUR 0.16 million, 83% in 4-6/2020).
• EBITDA improved to EUR -4.36 million (EUR -6.35 million).
• The operating loss improved to EUR –4.84 million (EUR –6.62 million).
• The loss for the period improved to EUR –5.34 million (EUR –6.76 million).
• Basic EPS was EUR -0.07 (EUR -0.14).
• The number of employees grew to 106 at the end of the review period (55).
• Cash position was EUR 88.1 million on June 30, 2021 (EUR 75.2 million).

H1/2021 key financials:

• Revenue EUR 0.82 million, growth + 141%, stemming from 16 different customer projects (EUR 0.34 million, 7 customer projects in 1-6/2020).
• The gross profit and gross margin jumped to EUR 0.76 million and 92%, respectively (EUR 0.26 million, 77% in 1-6/2020).
• EBITDA improved to EUR -8.28 million (EUR -10.49 million).
• The operating loss improved to EUR –9.20 million (EUR –10.99 million).
• The loss for the period improved to EUR –9.61 million (EUR –11.35 million).
• Basic EPS was EUR -0.14 (EUR -0.23).
• EUR 40 million (gross) was raised in a new share issue in March.

Significant events during H1/2021

• 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".
• In January, Nanoform announced positive interim results from its clinical study. The interim results suggested that a nanoformed oral piroxicam tablet achieved significantly faster absorption when compared to the reference tablet from the originator Pfizer.
• In February, Nanoform and Herantis Pharma Plc signed a Biologics Proof of Concept Agreement aiming to enhance nasal drug delivery to the brain of Herantis' CDNF therapies for Parkinson's disease using Nanoform's proprietary biological nanoparticle technology. As a result, Nanoform achieved its near-term business target of "First Biologics PoC project signed in 2021".
• In February, a PoC agreement was signed with an East Coast US Biotech Company.
• In February, Nanoform announced further positive interim results from its clinical study. The fast absorption data from the second part of the study implied that nanoforming might offer viable alternatives to complex formulation approaches such as cyclodextrin based technologies.
• In February, Nanoform appointed Dr Jamie Unwin as Commercial Insights Officer, based in Oxford UK, starting 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.
• In March, a PoC agreement was signed with a European Biotech Company.
• In March, Nanoform launched the next generation of its STARMAP^® artificial intelligence platform, v2.0. The technology utilizes sparse-data AI to augment experimental results from its CESS^® nanoparticle engineering process with detailed expert knowledge, allowing reliable predictions to be made regarding partners' potential success of nanoforming their drug molecules. STARMAP^® is a digital version of the CESS^® 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. The considerably oversubscribed capital raise attracted strong interest from Nordic and international investors, including a considerable number of large global Tier 1 institutional investors.
• In March, Nanoform appointed Dr Chris Worral as VP Business Development US, based in San Diego, starting 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.
• On April 6, at the AGM, the Board of Directors, chaired by Miguel Calado, was re-elected.
• In April, Nanoform and Aprecia, a US-based three-dimensional printing pharmaceutical company, announced that they are exploring the synergies between their respective technologies in the field of nanoparticle-enabled 3DP dosage forms. The collaboration targets to combine Nanoform's fast dissolution nanoformed particles with Aprecia's ZipDose-technology platform for rapid disintegration to enable high performance buccal and oral delivery of medicines to patients where rapid absorption is essential.
• In May, Nanoform announced the completion and final results of its clinical study. The primary, secondary and optional exploratory objectives of the study were all met. The results showed that Nanoform's CESS® technology enabled development of a fast-acting piroxicam immediate release tablet formulation with more rapid absorption and improved drug delivery performance in comparison to a standard reference IR tablet. The study outcome confirmed earlier published interim results and supports the clinical utility of Nanoform's technology and its potential applicability for producing fast-acting dosage forms for poorly soluble drugs.
• In May, Nanoform and a US listed metabolic pharmaceuticals company signed a collaboration agreement.
• In May, Nanoform and Celanese Corporation, a global specialty materials company, announced plans to explore the synergies between their respective technologies in the field of nanoparticle-enabled drug delivery. The goal is to assess the utility of combining Nanoform's nanoparticle platform technologies with Celanese's VitalDose^® EVA copolymer delivery technology for drug-eluting implants. The aims are to enable the development of next-generation drug delivery devices that support increased drug load and possess enhanced sustained release properties. Nanoform and Celanese intend to work on formulation development, leveraging each organization's unique formulation expertise.
• In May, a Proof of Concept contract was signed with a new client, a US Biotech company.
• 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, a letter of intent was signed with a European headquartered international company for the development, manufacturing, and commercialization of a by nanoforming improved version of a current blockbuster drug. The expected improvements will be focused on patient convenience. Nanoform has already started a Proof of Concept study on the asset, paid for by the partner, and are simultaneously in discussions for the execution of the definitive agreement for the further co-development and GMP manufacturing. The execution of the definitive agreement is dependent on the outcome of the PoC study and agreement on customary contractual terms with the partner.

Significant events after H1/2021

• In July, a Proof of Concept contract was signed with a new global major pharma customer.
• In July, a Master Services Agreement was signed with Boehringer Ingelheim. Proof of Concept studies may now be performed to assess the added value Nanoform's CESS^® technology can deliver to Boehringer Ingelheim's drug development projects.

CEO's review

To build, serve, and polish simultaneously - execution is key.

Nanoform has continued to execute strongly on all these three fronts during the last months. Our GMP expansion progresses according to timetable and budget, and we have now ordered the main equipment for GMP lines 2 and 3, which we target to have operational in 2022. In addition, we have engaged with an industrial gas company to take our (super critical CO₂) flow rates to the next level by installing a 40m³ tank that will allow us to take another logarithmic step in our manufacturing capabilities. This fits well with the recently signed letter of intent with a new client to develop, manufacture, and commercialize a by nanoforming improved version of a current blockbuster drug. If the ongoing POC project is successful, the following step in the plan is to move rapidly into GMP manufacturing of tens of kilograms of API for clinical studies. We're prepared for that.

We have thoroughly evaluated five global ERP vendors and their IT services partners during the last six months, and we are about to sign with the winning consortium. Implementing a new enterprise resource planning system is a large project that we will do in steps, starting with Finance and HR, before moving to Manufacturing, QC, QA etc. As a young company we have few legacy systems, and we use this opportunity to early on implement the best global pharma practices into all parts of Nanoform. In parallel, our ISO 27001 project has progressed nicely, and I expect it to be ready during 2021.

In June we held our first CMD, which included a live virtual tour of our facilities and a live demonstration of our CESS technology in action. Our Biologics team showed results on e.g. nanoformed insulin, on the extended size range of the molecules they work on (6 kDa - 140 kDa) and we are now ready to take on antibodies. The logarithmic productivity and capacity growth of our next generation STARMAP^® artificial intelligence platform was described by our R&D team. The very positive feedback we got from analysts and investors echoed that provided by pharma companies for which we have held similar live tours during the last year. Whereas we all look forward to some travelling and meetings in-person, it is clear that virtual tours are efficient economically and timewise, not forgetting that they are environmentally friendly. 

During the last months we've added additional line capacity, won more projects, signed new clients – of which two are global major pharma companies, entered into new collaborations, experienced the number of employees cross 100 and seen the gross margin jump above 90 per cent. Based on all this action in combination with client interaction, sales pipeline, and our recently strengthened commercial team, I'm confident that the coming quarters and years will continue to show strong commercial momentum.

Again, none of this could have been achieved 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

Company near-term business targets for 2021 and 2022 (re-iterarated)

• 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
• Two new GMP lines in 2022

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

• 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 Q2/2021 Interim Report can also be found at: https://nanoform.com/en/financial-reports-and-presentations/

Nanoform Q2/2021 Interim Report conference call and online presentation Aug 26, 2021 at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time

Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström and CCO Christian Jones. The presentation will be delivered in English.

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

https://financialhearings.com/event/13595

Teleconference dial-in numbers:

FI: +358981710522
SE: +46850558355
UK: +443333009263
US: +16467224902

For further information, please contact:

Albert Hæggström, CFO
albert.haeggstrom@nanoform.com / +358 29 370 0150

For investor relations queries, please contact:

Henri von Haartman, Director of Investor Relations
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 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. 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 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. 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.

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