Nanoform Finland Plc
May 25, 2023
08:10 a.m. Finnish time / 07:10 a.m. Swedish time
Nanoform Q1 2023 interim report – A strong start to the new year
A strong start to the new year. “Multi-API” license received, the clinical manufacture for “Project Blockbuster” commenced, 13 new non-GMP deals signed & three new major pharma relationships initiated, while the operating free cash flow has started to improve – a trend expected to continue in the coming quarters as our shift from investing & building to improving productivity & cash flow intensifies. The continued positive trend in customer interactions and proposals sent combined with a strong start to the year gives us confidence that our near-term business targets of “increased number of non-GMP and GMP projects signed in 2023 vs 2022” and “improved operating free cashflow in 2023 vs 2022” are achievable. Our balance sheet remains solid with EUR 63m in cash and no debt.
1-3/2023 key financials:
- Revenue came in at EUR 0.74 million, stemming from 24 customer projects (EUR 0.76m, 23 customer projects in 1-3/2022).
- The gross profit was EUR 0.58 million, with a gross margin of 78% (EUR 0.70m, 92%).
- Total operating costs* fell by 2% to EUR 5.2 million (EUR 5.3m).
- The number of employees grew by 17% to 152 (130) compared with one year ago.
- EBITDA improved slightly to EUR -4.5 million (EUR -4.6m).
- The operating loss was flat at EUR –5.1 million (EUR –5.1m).
- The loss for the period improved to EUR –4.5 million (EUR –5.3m).
- The operating free cashflow improved to EUR -6.2 million (EUR -6.9m).
- Basic EPS was EUR -0.06 (EUR -0.07).
- Cash position** was EUR 63.0 million on March 31, 2023 (EUR 91.7m).
(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
A strong start to 2023.
The increased customer momentum we saw in 4Q22 has continued during the first five months of this year. We have already signed 13 new non-GMP deals in 2023 – some including language around stage-gated GMP manufacture – making me confident that we can reach our 2023 business target of “increased number of non-GMP and GMP projects signed in 2023 vs 2022” when we signed 17+1 deals. Progress has also been made on the operating free cash flow, which improved by 10% without help from the topline yet. We expect the rate of improvement in operating free cash flow to increase in Q2 and later in the year. This is a clear testimony to the determination and teamwork of the Nanoformers. The swiftness with which we have been able to change focus from investing & building to improving productivity & cash flow while at the same time going live with SAP and serving a growing number of customers has been impressive.
I’m pleased to announce that Nanoform’s Manufacturer’s Authorization and GMP Certificate were updated in May to include nanoforming of multiple APIs in our GMP facility and that we after that immediately started the clinical manufacture for “Project Blockbuster”. This is a key milestone for the company on our journey to make nanoparticle medicines for patients! My special thanks go to the GMP Value Stream team from Manufacturing, Technical, Engineering, QA & QC, plus the PMO and R&D teams for all their contributions and team work to make this happen. Later this year, submissions will be made to the Finnish Medicines Agency to include new production areas and equipment and Quality Control laboratory areas in Nanoform’s GMP facility. This will help our gross margin return to the 90+ levels we target.
For Nanoform 2020-22 were years of building a capable organization and making large investments. 2023-25 will be about productivity increases and improved operating cashflow, working towards our 2025 midterm business target of becoming cash flow positive. The way to execute that is nontrivial but clear; to grow the topline and keep the operating costs and capital expenditure under control. In 2023 we see potential to progress on all three fronts. We’ve now reached a critical mass where we can serve dozens of clients in parallel on non-GMP projects, manufacture GMP material for several clinical trials annually, while helping our clients overcome their pharmaceutical development challenges. At the same time, we see significant potential to improve productivity and to increase the output of our quite impressive fleet of nanoforming lines and related capabilities. One concrete example is the number of projects we can do per line per year. Here we already ran five different client APIs on one of our non-GMP CESS® lines during 2022. If we can do that on all our ~20 lines, the productivity improvement will be significant. Another interesting insight during 2022 was that our Biologics lines should be able to do at least as many projects per line per year as the CESS® lines.
On the topic of our recent large investments, we are excited about our two new GMP lines which substantially increase our GMP capacity. Both pharma partners and investors who have visited us have been impressed by these high potency lines which provide containment to 30 ng/m³, multi-API capability (wash in place & clean in place) and automation (process control). This cleanliness level equals ~1 grain of sand in a 50m Olympic swimming pool. Another large investment during 2022 was our ERP project, evident in the IT costs during the year; after hard work by many Nanoformers, we successfully went live with SAP S/4HANA on Jan 2, 2023. The new software platform enables and supports implementation of best practices from the pharma industry and accelerates the continued industrialization and scale-up of our nanoforming services in the coming years.
All in all, I look forward with confidence and excitement to the coming quarters and years. The problem with bioavailability is enormous in the pharma industry, the R&D budgets of large pharma companies are huge, our brand recognition and service offering have continued to become stronger, the client response to that has been growing, and our strong balance sheet is a positive aspect when partners evaluate us. The strengthening trend of nearshoring and significant price increases in the global CDMO industry during the last years help us as our focus from the start has been on Europe, UK, and USA. 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.
Prof. Edward Hæggström, CEO Nanoform
Nanoform’s Q1 2023 interim report can be found at: https://nanoform.com/en/financial-reports-and-presentations/
Nanoform online presentation and conference call May 25, 2023, at 3:00 p.m. Helsinki time / 2:00 p.m. Stockholm time
Nanoform will publish its Q1 2023 interim report on May 25th, 2023, at 8.10 a.m. Finnish time / 7.10 a.m. Swedish 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 and CCO Christian Jones. The presentation will be delivered in English.
The presentation will be broadcast live as a webcast available at:
Teleconference dial-in numbers:
Dial-in number to the teleconference will be received by registering on the link below. After the registration you will be provided phone numbers and a conference ID to access the conference.
Significant events during 1-3/2023
- As of January 1, 2023, Antonio da Silva was appointed CBO and a member of the management team.
- Nanoform has established a new subsidiary in the UK, Nanoform U.K. Ltd on January 3, 2023.
- A total of 29,000 Nanoform Finland Plc’s new shares has been subscribed for with the Company’s stock options 3/2019, 5/2019 and 1/2020 on January 10, 2023. The entire subscription price for subscriptions made with the stock options of EUR 34 thousand was entered in the Company’s reserve for invested unrestricted equity.
- On February 28, Nanoform announced two new near-term business targets for 2023: “Increased number of non-GMP and GMP projects signed in 2023 vs 2022” and “Improved operating free cashflow in 2023 vs 2022”.
- During 1-3/2023 six new non-GMP projects were signed, both with new and repeat customers, both US and Europe based. We also signed our first major pharma customer from Japan.
- During 1-3/2023 one new non-GMP line was commissioned, taking the total number of lines to 19 non-GMP lines (14 CESS lines and 5 Bio lines) and one GMP line. GMP lines 2&3 will be commissioned after they are inspected and approved by Fimea.
Significant events after 1-3/2023
- Nanoform’s Annual General Meeting (the “AGM”) was held on April 12, 2023. The AGM approved the financial statements and discharged the Board of Directors and the CEO of the Company from liability for the financial year 2022. The Meeting decided that no dividend will be paid for the financial year that ended on December 31, 2022. The AGM further resolved the number of members of the Board of Directors to be four and the AGM re-elected Miguel Calado (Chairperson), Mads Laustsen, Albert Hæggström and Jeanne Thoma as ordinary members of the Board of Directors for the next term of office.
- On April 12, 2023, the Board of Directors approved share subscriptions based on stock option programs 2-3/2019 and 1/2020. A total of 37,000 Nanoform Finland Plc’s new shares has been subscribed and the entire subscription price for subscriptions made with the stock options of EUR 41 thousand was entered in the Company’s reserve for invested unrestricted equity.
- In April, Nanoform won a new grant from the Bill & Melinda Gates Foundation to work on several of the foundation’s drug development projects.
- In May Nanoform’s Manufacturer’s Authorization and GMP Certificate were updated to include nanoforming of multiple APIs in the GMP facility. Later this year, submissions will be made to the Finnish Medicines Agency to include new production areas and equipment and Quality Control laboratory areas in Nanoform’s GMP facility.
- Nanoform previously disclosed on November 15, 2021, that it has signed an agreement to manufacture nanoformed GMP material for a European headquartered international company. Following 12 months of preclinical development work, two privately held European pharmaceutical development and manufacturing organizations decided to join Nanoform and the European headquartered international company in funding the development and commercialization of this more patient centric version of a current blockbuster drug. For this purpose, the parties entered into a collaboration agreement on November 17, 2022. Under the terms of the agreement, Nanoform and the three other parties will fund in equal shares the completion of this development program. As Nanoform will continue to be remunerated for its work, the development stage of the collaboration is not expected to have a negative cash flow effect on Nanoform. In the event that the commercialization is successful, Nanoform expects to retain a 25 % share of the net-income received by the parties. In May 2023, after the Finnish Medicines Agency renewed Nanoform’s GMP license, Nanoform commenced the clinical manufacture related to this project. The campaign is expected to take a couple of months and the produced nanomaterial is expected to be shipped for manufacture of final drug product during 3Q23. The human pilot PK study is expected to commence in 4Q23 and the read-out is expected in 1Q24.
- During April and May seven new non-GMP projects were signed, taking the total of new non-GMP projects signed since the beginning of the year to 13.
Company near-term business targets for 2023 (re-iterated)
- Increased number of non-GMP and GMP projects signed in 2023 vs 2022
- Improved operating free cashflow in 2023 vs 2022
Company mid-term business targets 2025 (reiterated)
- 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
email@example.com / +358 29 370 0150
For investor relations queries, please contact:
Henri von Haartman, Director of Investor Relations
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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.
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, 2022 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.