Inhalation Sciences Sweden AB (publ) releases Year-end Report January 1 – 31 December 2021
(Stockholm, Sverige, 28 February 2022) Inhalation Sciences AB announces that its Year-end Report 1 January – 31 December 2021 is now available on the company’s website.
To read the whole Report (in Swedish), visit: http://inhalation.se/investors/finansiella-rapporter/
Summary of report
• Net sales in Q4 increased by 97% compared with the same period last year. Order intake increased by 12%, while the order backlog increased by as much as 106% compared with Q4 2020.
• The number and total value of our quotation requests increased by 50% compared with the same period in the previous year.
• The clinical study of PreciseInhale was successfully completed on schedule and within budget. We are now preparing to chart the optimal way forward for the company in a clinical environment.
• The company has initiated an upgrade of our quality management system with the goal of becoming fully compatible with ISO 13485, a quality system that can be used by industry in both pre-clinic and clinic.
Fourth quarter (Oct-Dec) 2021
Net sales kSEK 4,160 (2,114)
Operating profit kSEK -3,055 (-4,257)
Earnings per share before dilution SEK -0.27 (-0.50)
Earnings per share after dilution SEK -0.27 (-0.50)
Order intake * during the period kSEK 7,305 (6,540)
Order backlog ** at the end of the period kSEK 5,040 (2,445)
Reporting period (Jan-Dec) 2021
Net sales kSEK 9,422 (10,137)
Operating profit kSEK -16,571 (-8,741)
Earnings per share before dilution SEK -1.46 (1.14)
Earnings per share after dilution SEK -1.46 (1.14)
Order intake during the period kSEK 9,930 (9,890)
Order backlog at the end of the period kSEK 5,040 (2,445)
Selected financial data in summary
| 2021Oct-Dec | 2020Oct-Dec | 2021Jan-Dec | 2020Jan-Dec | |
| Net sales kSEK | 4 160 | 2 114 | 9 422 | 10 137 |
| Operating profit kSEK | -3 055 | -4 257 | -16 571 | -8 741 |
| Profit after tax kSEK | -3 084 | -4 288 | -16 609 | 9 875 |
| Balance sheet, total kSEK | 26 112 | 18 488 | 26 112 | 18 488 |
| Cash flow for period, kSEK | -4 074 | -3 417 | 6 348 | 3 249 |
| Cash flow for period, per share (SEK) | -0,36 | -0,4 | 0,63 | 0,38 |
| Cash and cash equivalents kSEK | 14 395 | 8 047 | 14 395 | 8 047 |
| Earnings per share before dilution kSEK | -0,27 | -0,5 | -1,46 | 1,14 |
| Earnings per share after dilution kSEK | -0,27 | -0,5 | -1,46 | 1,14 |
| Equity, kSEK | 19 678 | 10 475 | 19 678 | 10 475 |
| Equity per share (SEK) | 1,73 | 1,21 | 1,73 | 1,21 |
| Equity ratio, % | 75,36% | 56,66% | 75,36% | 56,66% |
| R&D costs / operating costs, % | 45,45% | 41,89% | 45,59% | 43,91% |
| Number of shares | 11 375 734 | 8 635 180 | 11 375 734 | 8 635 180 |
The company
Inhalation Sciences Sweden AB (publ), Org. Nr. 556665-6038, is a public limited company registered in Sweden with its registered office in Huddinge. The company's head office is located at Hälsovägen 7, 141 57 Huddinge.
The company conducts sales and development of technically advanced laboratory systems in inhalation, with the main product PreciseInhale® and associated modules as well as advanced contract assignment services through the IRS. Both business areas include lung research, where accurate measurements of drug substances and particles in inhaled air provide answers to how these behave in the lungs and thus affect individuals' health.
Significant events during the fourth quarter (Oct-Dec) 2021
• On October 19, the company signed a new order with a large Chinese pharmaceutical company to the value of SEK 2,025,000. The order includes a PreciseInhale® system and DissolvIt®.
• On October 25, the company announced that it had received the important patent for the cell culture module XposeALI® extended in the USA until 2034.
• On October 29, the company signed a new order with a large global pharmaceutical company worth SEK 2,900,000. This order is one of the largest in the company's history and includes a PreciseInhale® system. The pharmaceutical company is already a customer of ISAB.
• On November 9, ISAB signed a new order for its new In Vivo module for mice with the Italian pharmaceutical company Chiesi. The value of the order is SEK 355,000 and Chiesi is already a customer of ISAB.
• On November 17, the company announced that it had signed a new contract research assignment (IRS) with Akari Therapeutics. The value of the contract is SEK 900,000 and includes the company's IPL method (Isolated Perfused Lung) for Akari's latest pharmacokinetic study.
• On November 19, the company announced that it has extended its leasing agreement with Karolinska Institutet (KI). The agreement applies to the company's new module for guinea pigs and is worth SEK 100,000. On December 8, the company announced that it had signed an important research project together with Chiesi and Karolinska Institutet (KI) for a value of SEK 550,000.
• On December 8, the company announced that it had signed an important research project together with Chiesi and Karolinska Institutet (KI) for a value of SEK 550,000.
• On December 20, the company announced that it has completed the ongoing clinical study of PreciseInhale® systems where it has achieved set goals with precise dosing and control. This is probably one of the company's biggest milestones and opens up the possibility of a clinical market for ISAB valued at at least SEK 5 billion.
Significant events during the reporting period (Jan-Dec) 2021
• On February 10, ISAB announced that it has acquired an expanded internationally registered trademark for PreciseInhale® in strategic markets such as the United States, India and China
• On August 16, the company announced that it had received the important patent for aerosol generation via PreciseInhale® extended in the US until August 2034.
• On October 12, ISAB announced the renewed collaboration with Karolinska Institutet regarding the validation of the new module XposeAli® MP (Micro Perfusion) and the Moondust study.
• On September 29, ISAB announced its collaboration with Redeye for company analysis and expanded collaboration regarding IR activities.
• On November 25, ISAB announced that it has registered a trademark for PreciseInhale®, DissolvIt® and XposeALI® in the United States.
Significant events after the reporting period
• On January 18, the company announced that it had sent an application for a study (white paper) to the FDA. This applies to DissolvIt® and to be able to get it approved as the recommended dissolution method for inhalation studies.
Company events
At the Annual General Meeting on June 8, 2021, the Board members Per Gerde, Sonja Gerde and Klaus Gottwald, Mårten Winge and Daniel Spasic were re-elected. Daniel Spasic was elected Chairman of the Board. Order intake is the value of products and services sold during the current period, ie sales and not to be confused with net sales.
| kSEK | 2021 | 2020 | 2019 | 2018 | 2017 | 2016 | 2015 |
| Net sales | 9 422 | 10 137 | 8 949 | 5 441 | 8 022 | 7 216 | 8 086 |
| Profit after net financial items | -16 609 | 9 875 | -4 345 | -11 883 | -6 358 | -5 365 | -2 854 |
| Balance sheet total | 26 112 | 18 488 | 23 198 | 19 653 | 23 313 | 10 427 | 9 191 |
| Equity ratio, %, | 75 | 57 | 22 | 55 | 68 | 40 | 26 |
| Average no. of employees | 9 | 8 | 7 | 6 | 5 | 5 | 5 |
CEO STATEMENT
The financial year 2021 continued to be another year with the challenges of COVID-19 effecting our operations. However, despite the challenges and restrictions we have managed to navigate the year successfully and are proud to be able to sum up the year as a positive and successful one for Inhalation Sciences AB.
Quarter 4, 2021 can be summarized as follows:
• Sales reached a peak of just over SEK 7,300,000 in sales orders received. We have shipped and invoiced some of these during the same period and continue to work our order backlog in the coming months.
• The clinical study of PreciseInhale was successfully completed with demonstrated efficacy regarding 1) precise and accurate dosing (regional targeting) and 2) greater efficacy compared to a standard inhaler in a clinical setting. The study was completed on time and budget and we are now preparing to chart the optimal way forward for the company in a clinical environment.
• An application to the US Food and Drug Administration (FDA) was submitted in January 2022 with the goal of obtaining an FDA recommendation for our dissolution module DissolvIt in inhalation research and development. The application is the result of several months of dialogue with the FDA, and the market potential for DissolvIt following a possible FDA recommendation is enormous given that we are establishing the method as a "Golden Standard Dissolution method". This may guide customers and research institutes in inhalation research and development to the company.
In addition to achieving these important strategic goals, we have also continued to process existing and new customers. The value of our quotation requests has increased by 50% compared with the same period the year before. We also plan to further strengthen our commercial organization in early 2022.
Finally, the company has initiated an upgrade of our quality management system with the goal of becoming fully compatible with ISO 13485, a quality system that can be used by industry in both pre-clinic and clinic. The demands on the company and our products and services will increase over time, driven by both regulatory standards and the expectations of our customers.
I look forward confidently to an exciting 2022 where we can continue to work based on our strategic plan, develop Inhalation Sciences AB together with our customers and increase added value for our partners and owners.
Huddinge on 28 February 2022
Manoush Masarrat
VD
To read full report (in Swedish) go HERE.
For more information about Inhalation Sciences, please contact:
Manoush Masarrat, CEO
E-mail: Manoush.masarrat@inhalation.se
Mobile: +46 (0)73 628 9153
About Inhalation Sciences Sweden AB (publ)
Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments and services for research into inhalation. The company’s patented lab instruments PreciseInhale® and DissolvIt® enable researchers in the pharma industry to make drug pipeline decisions at an early stage, saving time and resources for R&D departments, and enables researchers in academic institutions to define how aerosols and small particles impact our lungs, and so our health, when being inhaled.
The information above was provided by Inhalation Sciences Sweden AB (publ) through the above contact person, for publication on February 28, 08.00 (CET), 2022.
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