HELSINKI, Nov. 27, 2020 /PRNewswire/ -- Strong momentum continues: first GMP campaign initiated, first dosing in humans to start before year-end, all near-term business targets set out in IPO to be achieved ahead of schedule, new global major pharma client signed, two new PoC projects started, one more non-GMP line commissioned and a new near-term business target introduced: "First Biologics PoC project in 2021".
7-9/2020 key financials:
- Revenue was EUR 159 thousand, during 7-9/2019 there were no revenues.
- The gross profit and margin came in at EUR 101 thousand and 63%, during 7-9/2019 the gross profit was negative.
- The operating loss was EUR -3.8 million (operating loss was EUR -2.1 million in 7-9/2019).
- The loss for the period was EUR -4.2 million (EUR -2.2 million in 7-9/2019).
- Basic EPS was EUR -0.06 (EUR -0.05).
- The number of employees grew to 68 at the end of 7-9/2020 (34 employees at the end of 7-9/2019).
- Cash position was EUR 66.6 million on September 30, 2020 (EUR 10.3m on September 30, 2019).
1-9/2020 key financials:
- Revenue was EUR 501 thousand and stemmed from nine different customer projects. In 1-9/2019 there were no revenues.
- The gross profit and margin came in at EUR 363 thousand and 72%, respectively. In 1-9/2019 the gross profit was EUR -182 thousand.
- The operating loss and the loss for the period were EUR -14.8 million and EUR -15.5 million, respectively. In 1-9/2019 the operating loss and the loss for the period were EUR -4.7 million and EUR -5.0 million, respectively.
- Basic EPS was EUR -0.29 (EUR -0.12).
- EUR 79.9 million (gross) was raised in the IPO.
Significant events during 1-9/2020
- In January Nanoform USA Inc. (100% owned subsidiary in the US) was established.
- In March Nanoform signed two new agreements, one with a global major pharma company and one with Orion Corporation, a repeat customer.
- In March two new non-GMP lines were commissioned.
- On April 7, at the AGM, Miguel Calado was appointed chairman of the Board of Directors, after being vice chairman for a year.
- In April Nanoform was awarded Good Manufacturing Practices (GMP) status by the Finnish Medicines Agency, FIMEA.
-In April the Company's form was changed to a public limited liability company and the share capital was increased to EUR 80 thousand.
- Early June, EUR 79.9 million (gross) was raised in a successful IPO on Nasdaq First North Premier Growth Markets in Finland and Sweden. The considerably oversubscribed offering attracted strong interest from Global, European, and Nordic investors. Trading started on June 4, 2020.
- In June a proof-of-concept contract was signed with a UK Respiratory Biotech company.
- In June Nanoform expanded its US commercial team by appointing Eric Peter and Sergie Letser to drive the business development in the US, starting September 1, 2020.
- During 4-6/2020 one new non-GMP line was commissioned, taking our capacity to seven non-GMP lines and one GMP line on the small molecules side.
- In June Nanoform appointed Peter Hänninen as General Counsel, starting September 1, 2020.
- 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.
- Cynthia Schwalm was appointed ordinary member of the Board of Directors at the EGM, September 1, 2020.
- In September, a new global major pharma customer was signed.
Significant events after 7-9/2020
- On October 20, a major milestone and mid-term business target was achieved when Nanoform announced that it had initiated its first GMP campaign for the first ever human trial of a drug candidate nanoformed using Nanoform's proprietary CESS® technology. Dosing was announced to begin before year-end 2020 (previously: in 2021) and results are expected before the end of Q2/2021.
- In October Johanna Tuomisto was appointed HR Director, starting January 1, 2021. Johanna joins Nanoform from a position as HR Director for Thermo Fisher Scientific Oy in Finland. She holds a Master of Law degree from the University of Helsinki.
- In November, a new non-GMP line was commissioned, taking our capacity to eight non-GMP lines and one GMP line on the small molecules side.
- On November 27, a new near-term business target was announced: "First Biologics PoC in 2021".
In a fast-moving company where the focus is intensely on future goals and daily demands, the quarterly reports give me the opportunity to reflect on and measure what has been achieved since last reporting to you. These reports help me deliver on the annual goals.
During the last month Nanoform has reached two major milestones on its long-term trajectory:
(1) the first GMP campaign was initiated and before year-end dosing will start in the first-ever human trial of a drug candidate nanoformed using Nanoform's proprietary CESS® technology. This is something the founders of Nanoform and I have diligently worked towards for more than a decade. Results are expected before the end of Q2/2021 and we are waiting for them with excitement.
(2) our technology for Biologics is now ready to be introduced to pharma customers, hence our new near-term business target "First Biologics PoC in 2021".Compared to the journey with our CESS® technology for small molecules, I see a faster and clearer early path with lots of synergies and structures already in place (organization, GMP, QC, QA, PM, commercial etc.) and market position (brand awareness, client relationships etc.). Hence, we are all very excited, as the opportunities within Biologics are vast.
During Q3 Nanoform has continued to show strong momentum; in addition to the above mentioned, we have won additional clients, added line capacity, started new customer projects, doubled our sales force, strengthened our board, and continued to attract exceptional individuals from all over the world. For 2020, the list of achievements is even longer: establishing a US subsidiary, getting a GMP certificate, dual-listing, raising EUR 80m, more than doubling the number of clients, more than tripling the number of projects running in parallel, almost doubling the number of employees and most importantly initiating our first GMP campaign and soon dosing in humans. And all this during the corona crisis tells something about our will to win.
Having met our near-term business targets set out ahead of the IPO, my focus is now on ensuring that Nanoform enters the next stage on its growth trajectory. By that I mean the world of GMP projects supplying material to clinical trials with the long-term vision to help a billion patients. We have added a new near-term business target and will in the coming months add a few more targets for 2021 and 2022. Our 2025 mid-term targets are unchanged.
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 only begun, let's make the next five years as exciting and fast paced as the first five have been!
Prof. Edward Hæggström, CEO Nanoform
Company near-term business targets for 2020 and 2021
- to acquire more new customers in 2020 than in 2019 (achieved in July)
- to start its first GMP project before year-end 2020 (achieved on October 20th)
- first dosing in humans before year-end 2020 (changed from in 2021 on October 20th)
- First Biologics PoC project in 2021 (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 Interim Report January - September 2020 can also be found at: https://nanoform.com/en/financial-reports-and-presentations/
Nanoform 1-9/2020 Conference Call Friday November 27th 15:00 p.m. Helsinki time (14:00 p.m. Stockholm time)
Nanoform will be represented by CEO Edward Hæggström, CFO Albert Hæggström, CTO Niklas Sandler, CCO Christian Jones and CBO Gonçalo Andrade. The presentation will be delivered in English.
The presentation will be broadcast live as a webcast available at: https://financialhearings.com/event/13383
Teleconference dial-in numbers:
United Kingdom: +443333009263
United States: +18332498407
For further information, please contact:
Albert Hæggström, 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
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 attrition in clinical trials and on enhancing drug molecules' formulation performance through its nanoforming services. Nanoform's capabilities span the small to large molecule development space and the company focuses 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 40 562 1806. For more information please visit http://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 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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