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    NANOFH   FI4000330972

NANOFORM FINLAND OYJ

(NANOFH)
  Report
Delayed Quote. Delayed Nasdaq Helsinki - 01/26 11:29:37 am
5.51 EUR   -1.96%
01/03Nanoform sets two new near-term business targets for 2022
AQ
2021Nanoform financial calendar for 2022
AQ
2021NANOFORM FINLAND OYJ : Interim Report January – September 2021
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Nanoform Finland Oyj : Interim Report for January-September 2021 – Report

11/18/2021 EST

®

®

Interim Report

January-September 2021

®

Nanoform's January-September 2021 review:

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 % com- pared with EUR 0.16 million in 7-9/2020.
  • The gross profit more than quadrupled to EUR 0.42 mil- lion as the gross margin jumped to 88% (EUR 0.10 mil- lion, 63% in 7-9/2020).
  • EBITDA came in at EUR -4.62 million (EUR -3.49 million).
  • The operating loss was EUR -5.11 million (EUR -3.81 mil- lion).
  • The loss for the period was EUR -4.51 million (EUR -4.16 million).
  • Basic 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 profit 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 mil- lion).
  • 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 EPS was EUR -0.21 (EUR -0.29).
  • EUR 40 million (gross) was raised in a new share issue in March.

(Numbers in brackets refer to the corresponding last year reporting period, unless otherwise mentioned.)

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".
  • In January, Nanoform announced positive interim results from its clinical study. The interim results suggested that a nanoformed oral piroxicam tablet achieved sig-

nificantly 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 Nano- form'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 absorp- tion data from the second part of the study implied that nanoforming might offer viable alternatives to com- plex formulation approaches such as cyclodextrin based technologies.
  • In February, Nanoform appointed Dr Jamie Unwin as Commercial Insights Officer, based in Oxford UK, start- ing 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 tech- nology utilizes sparse-data AI to augment experimental results from its CESS® nanoparticle engineering process with detailed expert knowledge, allowing reliable pre- dictions to be made regarding partners' potential suc- cess of nanoforming their drug molecules. STARMAP® is a digital version of the CESS® technology that enables in silico experiments in large quantities, creating fast pre- dictions of which molecules should be nanoformed.
  • In March, EUR 40 million (gross) was raised in a success- ful new share issue through an accelerated bookbuild- ing process. The considerably oversubscribed capital raise attracted strong interest from Nordic and inter- national investors, including a considerable number of large global Tier 1 institutional investors.
  • In March, Nanoform appointed Dr Christopher Worral as VP Business Development US, based in San Diego, starting in May.
  • During 1-3/2021 three new non-GMP lines were com- missioned. 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.

Interim Report | January-September 2021

2

®

  • In April, Nanoform and Aprecia, a US-basedthree-dimen- sional printing pharmaceutical company, announced that they are exploring the synergies between their respective technologies in the field of nanoparticle-en- abled 3DP dosage forms. The collaboration targets to combine Nanoform's fast dissolution nanoformed par- ticles 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® tech- nology 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 pharma- ceuticals 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 tech- nologies 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 technol- ogy 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 PoC contract was signed with a new client, a US Biotech company.
  • On June 2, Nanoform raised its mid-term business tar- gets for 2025. The new targets are:
    • To nanoform annually at least 70 new active phar- maceutical 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 operat- ing 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 tech- nology, 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 develop- ment, 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 PoC 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 defin- itive agreement is dependent on the outcome of the PoC study and agreement on customary contractual terms with the partner.
  • In July, a PoC 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 Nano- form's CESS® technology can deliver to Boehringer Ingelheim's drug development projects.
  • In August, a fourth PoC project was started with a global major pharma customer.
  • In September, Herantis Pharma Plc announced successful results from its project with Nanoform, where the aim is to enhance nasal drug delivery to the brain of Herantis' CDNF therapies for Parkinson's disease by using Nano- form's proprietary biological nanoparticle technology. The PoC project showed that the nanoforming process was successfully applied to rhCDNF. During the nanopar- ticle formation process, rhCDNF protein remained stable, retaining its structure, function, efficacy, and neuropro- tective effects in line with CDNF controls.
  • In September, Nanoform appointed Dr Nathalie Huther as VP Business Development Europe, based in the UK, starting in November.
  • In September, Nanoform signed a contract for the implementation of a new enterprise resource planning system. The ERP system will be based on SAP's S/4HANA solution and Nanoform's partners in the implemen- tation 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 head- quartered 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® nanoparti- cle engineering technology can deliver to several of the foundation's drug development projects.

Interim Report | January-September 2021

3

®

Significant events after 1-9/2021

  • On November 12, Nanoform announced that it had received ISO/IEC 27001:2013 certification for its Infor- mation Security Management System (ISMS). The ISMS applies to all information, systems, processes, and peo- ple that operate, store, handle, and process Nanoform's and its client's trusted data.
  • On November 15, Nanoform announced that it had signed a GMP agreement with a European headquar- tered 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 ordi- nary 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".

Nanoform 1-9/2021 Conference call

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 hold a conference call and an online presentation on 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: https://financialhearings.com/event/13596

Teleconference dial-in numbers:

Finland: +358931583775

Sweden: +46856642704

Norway: +4723963938

Denmark: +4578150108

United Kingdom: +443333009034

United States: +16467224956

Interim Report | January-September 2021

4

®

Nanoform Group's key figures

Financial KPI's

EUR thousand

7-9/2021

7-9/2020

1-9/2021

1-9/2020

1-12/2020

1-12/2019

Revenue

475

159

1,300

501

687

49

Revenue growth %

198%

n.m.

159%

n.m.

n.m.

n.m.

Gross profit

419

101

1,180

363

497

-323

Gross margin

88%

63%

91%

72%

72%

neg.

EBITDA

-4,615

-3,488

-12,898

-13,973

-18,196

-6,900

Operating loss

-5,108

-3,806

-14,312

-14,793

-19,423

-7,344

Loss for the period

-4,513

-4,155

-14,123

-15,500

-19,441

-7,554

Basic EPS (EUR)

-0.06

-0.06

-0.21

-0.29

-0.35

-0.19

Net debt

-74,788

-59,773

-74,788

-59,773

-54,156

-3,640

Net debt excluding lease liabilities

-82,372

-65,602

-82,372

-65,602

-59,977

-6,626

Investments in property, plant and equipment

-1,804

-545

-4,462

-1,383

-2,336

-1,804

Operative free cash flow

-6,420

-4,034

-17,361

-15,356

-20,532

-8,704

Cash and cash equivalents (end of period)

82,372

66,600

82,372

66,600

61,025

7,303

Operational KPI's

EUR thousand

7-9/2021

7-9/2020

1-9/2021

1-9/2020

1-12/2020

1-12/2019

Number of new customer projects started

during the period

Non-GMP

6

2

14

7

10

2

GMP

0

0

0

0

0

0

Number of lines (end of the period)

Non-GMP

13

7

13

7

8

4

GMP

1

1

1

1

1

0

Number of employees (end of the period)

116

68

116

68

74

43

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

Interim Report | January-September 2021

5

Disclaimer

Nanoform Finland Oyj published this content on 18 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 November 2021 08:09:01 UTC.


© Publicnow 2021
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Financials
Sales 2021 2,05 M 2,30 M 2,30 M
Net income 2021 -20,2 M -22,7 M -22,7 M
Net cash 2021 70,2 M 78,8 M 78,8 M
P/E ratio 2021 -19,0x
Yield 2021 -
Capitalization 400 M 451 M 449 M
EV / Sales 2021 161x
EV / Sales 2022 42,0x
Nbr of Employees 116
Free-Float -
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Edward Hæggström Chief Executive Officer
Albert Häggström Chief Financial Officer & Director
Miguel Maria de Oliveira Barreiros Calado Chairman
Niklas Sandler Chief Technology Officer
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