Inhalation Sciences AB (publ) releases Q2 Report 2022
(Stockholm, Sweden, 29 August 2022) Inhalation Sciences AB announces that its interim report for the second quarter 2022, January 1 – June 30, is now available on the company’s website. To read the whole report (in Swedish), visit: http://inhalation.se/investors/finansiella-rapporter/
Summary of the interim report
After processing our FDA application and submitting the requested additional documentation, we have now been granted approval to begin our study. It will be co-funded by the FDA by up to 250,000 USD per year for a 2-year period and will be based on in vitro studies and analysis of a relatively large number of compounds using ISAB's DissolvIt platform.
Sales in Q2 2022 increased by over 220% compared to the same period last year. This was mainly driven by the successful delivery of a number of large orders received in previous periods. Order intake in the same period has been weaker than anticipated, given the continued strong interest from existing and new customers this is considered temporary. Additionally, some planned orders that would have been closed for the period, have for various reasons now been moved forward to the next period.
We have processed the data from our completed Phase I clinical trial and will shortly be ready to present results. As a first step, we have now submitted an abstract to present the data at the upcoming DDL (Drug Delivery to The Lungs) meeting in Edinburgh in December. These results describe both the precision dosing of our technology and its ability to perform so-called "regional targeting" in the lungs.
ISAB's quality management system has been updated in accordance with ISO13485.
April – June 2022
Net sales SEK 4,241 (1,295)
Operating profit SEK -4,037 (-3,564)
Earnings per share before dilution SEK -0.36 (-0.56)
Earnings per share after dilution SEK -0.36 (-0.50)
Order intake during the period kSEK 764,000 (1,195)
Order backlog at the end of the period kSEK 434,000 (898)
January – June 2022
Net sales SEK 6,301 (4,134)
Operating profit SEK -7,413 (-9,070)
Earnings per share before dilution SEK -0.66 (-0.91)
Earnings per share after dilution SEK -0.66 (-0.81)
Order intake received during the period kSEK 3,525 (1,195)
Order backlog at the end of the period kSEK 4,334 (898)
Order intake is the value of products and services sold during the current period, i.e. sales, and not to be confused with net turnover.
Order backlog is signed customer contracts for both products and services that have not yet been invoiced to customers, where work is still in progress and delivery has not yet been made to the customer.
Selected financial data in summary
| 2022Apr-Jun | 2021Apr-Jun | 2022Jan-Jun | 2021Jan-Jun | 2021Jan-Dec | |
| Net sales kSEK | 4,241 | 1,295 | 6,301 | 4,134 | 9,422 |
| Operating profit kSEK | -4,037 | -5,506 | -7,413 | -9,070 | -16,571 |
| Proft after tax kSEK | -4,063 | -5,585 | -7,465 | -9037 | -16,609 |
| Balance sheet total kSEK | 17,350 | 32,145 | 17,350 | 32,145 | 26,112 |
| Cash flow for period, kSEK | -5,007 | 16,198 | -9,405 | 12,094 | 6,348 |
| Cash flow for period, per share (SEK) | -0.44 | 1.44 | -0.83 | 1.08 | 0.63 |
| Cash and cash equivalents kSEK | 4,990 | 20,141 | 4,990 | 20,141 | 14,395 |
| Earnings per share before dilution kSEK ) | -0.36 | -0.56 | -0.66 | -0.91 | -1.46 |
| Earnings per share after dilution kSEK | -0.36 | -0.50 | -0.66 | -0.81 | -1.46 |
| Equity kSEK | 12,213 | 25,919 | 12,213 | 25,919 | 19,678 |
| Equity per share (SEK) | 1.07 | 2.31 | 1.07 | 2.31 | 1.73 |
| Equity ratio, % | 70.39% | 80.63% | 70.39% | 80.63% | 75.36% |
| R&D costs(operating costs | 41.29% | 46.48% | 21.93% | 44.13% | 45.59% |
| Number of shares | 11,375,734 | 11,225,734 | 11,375,734 | 11,225,734 | 11,375,734 |
Significant events during the second quarter (April-June) 2022
- On 1 April, the company announced an IRS (Inhalation Research Services) order from a returning customer with a value of SEK 491,000.
- On 11 April, the company announced new distribution agreements in strategic markets such as the UK, China and Hong Kong.
- On May 5, ISAB announced positive feedback from the FDA regarding its submitted application for DissolvIt and a request for additional documentation to be submitted within 30 days.
- On 6 May, ISAB's Annual General Meeting was held by postal vote, where all proposals were approved.
- On 24 May, the company announced that it has obtained a credit line of up to SEK 10 million, which will create room to finance the company's operations over the next 12-14 months.
- On 23 June, ISAB announced a new IRS order from a returning customer with a value of SEK 581,000.
- On June 29, the company reported the publication of positive data using its platform technology in "the Journal of Environmental Science and Pollution Research”
Significant events during the reporting period (January-June) 2022
- On January 18, the company announced that it submitted a study application (whitepaper) to the FDA (US Food and Drug Administration) concerning DissolvIt, to obtain FDA approval of DissolvIt as a recommended dissolution method in inhalation studies.
- On February 14, the company announced that it is upgrading its quality management system (QMS) and expects to have the job completed by the end of June 2022.
Significant events after the reporting period
- On 18 July, the company announced an IRS (Inhalation research Services) order from a new pharmaceutical company client in the US with a value of SEK 1,450,000.
- On 19 July, ISAB announced that it has submitted an abstract to present results from the clinical trial to the upcoming DDL (Drug Delivery to the Lungs) conference in December 2022 to be held in Edinburgh, Scotland.
- On 4 August, the company announced that the FDA has approved the submitted application for the planned DissolveIt study and that it is scheduled to start in the autumn of 2022.
- On January 18, the company announced that it had sent an application for a study (white paper) to the FDA (US Food and Drug Administration) seeking to get FDA approval of DissolvIt as a recommended dissolution method for inhalation studies.
- On February 14, the company announced that it is upgrading its quality management system (QMS) and expects to have the job completed by the end of June 2022.
- On February 18, ISAB announced a new IRS order from a leading customer in nanotechnology, with a total value of SEK 584,000.
- On March 14, the company announced a new order from RISE (The Research Institute of Sweden) for a new Nebulizer, with a total value of EUR 23,500.
- On March 18, ISAB announced a new IRS order from a Swiss generic company, with a total value of EUR 74,000.
Company events
At the Annual General Meeting on May 6, 2022, 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.
| Multi-year overview | |||||||
| Tkr | 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. o0f employees | 9 | 8 | 7 | 6 | 5 | 5 | 5 |
CEO statement
The first six months of 2022 have been intensive with a range of exciting activities taking place across many fronts:
- Regulatory: after processing our FDA application and submitting requested documentation, we have now been granted approval to begin our study. It will be co-funded by the FDA by up to USD 250,000 per year for a 2-year period and will be based on in vitro studies and analysis of a relatively large number of compounds with ISAB's DissolvIt. This is one of the biggest milestones in the company's history. We are very much looking forward to conducting this study with the goal of making DissolvIt an FDA-recommended dissolution technology for In vitro studies.
- Commercial: Sales in Q2 2022 increased by over 220% compared to the same period last year. This is primarily driven by the successful delivery of a number of large orders received in prior periods. Order intake in the same period has been weaker than anticipated, which is considered to be temporary given the continued strong interest we are receiving from existing and new customers. We continue to work our pipeline and see a strong increase of around 50% compared to the same period last year.
- Clinical: We have processed data from the completed Phase I clinical trial and will present the results shortly. As a first step, we have now submitted an abstract to present at the upcoming DDL meeting in Edinburgh in December. The clinical market represents a huge potential for our technology platform, constituting a market size quadrupled to approximately 8 billion SEK.
- Quality management system: last but not least, we have now updated our quality management system in accordance with ISO13485 and are prepared to take on new regulatory requirements placed on us as a company, both in the preclinical market where we are today, and for a clinical application further down the road.
We look forward to an eventful second half of the year for ISAB. I, along with our great team are ready to take on the opportunities we have in front of us to further develop ISAB and deliver on the strategic goals we have set for the company.
Huddinge, 29 August 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 August 29, 2022.