Cell therapy production in a clean-room like environment
Cell therapy manufacturing

Interim Report 2 (2021-08-01 – 2021-10-31)

Phase Holographic Imaging PHI AB (publ)

Lund, December 29, 2021

august 2021 – october 2021

Net sales1 818 (826) KSEK
Operating result before depreciation (EBITDA)-2 733 (-2 946) KSEK
Net result -3 901 (-4 777) KSEK
Earnings per share-0.27 (-0.33) SEK
Gross margin93 (77) %

MAY 2021 – OCTOBER 2021

Net sales4 191 (957) KSEK
Operating result before depreciation (EBITDA)-6 172 (-7 495) KSEK
Net result -8 370 (-11 194) KSEK
Earnings per share-0.58 (-0.78) SEK
Gross margin75 (64) %

In short

CEO Commentary

A window of opportunity created by the advancement of regenerative medicine

PHI spearheads the next generation of advanced instrumentation for non-invasive imaging and ana­ly­sis of cell cultures. Today, cells are cultured in well over 100 000 labora­tories world­wide, academic and commercial.

The growth rate and advances in regenerative medicine have motivated Big Pharma to enter the field. In regene­rative medicine, the cells themselves are the treatment. Therefore, the number of cell culture laboratories and the market for non-invasive cell culture analysis is expected to grow rapidly over the coming years.

The growth is driven by the demand for large-scale cell culturing capacity to treat major diseases like diabetes, Parkinson’s, Alzheimer’s, heart disease and several cancer forms. As cell culturing transform from a craft to large-scale industry, the future number of clinical cell culture laboratories is expected to dwarf the current +100 000 pre-clinical laboratories.

In addition to its pre-clinical business, we see that PHI has a significant competitive advantage within regenerative medicine, given PHI’s proven core technology, proprietary software and cost position. Our customers have collectively published over 200 scientific papers based on results created by PHI’s non-invasive cell analysis technology. PHI’s more well-known customers include Bayer AG, National Institutes of Health, Harvard and Stanford University, and Novo Nordisk A/S.

The Future of Medicine

Regenerative medicine is the collective term for treatments that regrow, repair or replaces dam­aged or diseased cells, organs or tissues. The rapidly expanding field includes the gene­ration and use of thera­peutic stem cells, tissue engi­neering and the production of artificial organs.

Drawing of showing the principle of cell therapy
Gene and cell-therapies involve extracting cells from the patient or a donor, modifying and multi­plying the cells in a laboratory before trans­planting the treat­ment cells back to the patient.

The Future is Here

According to the latest report from Alliance for Regenerative Medi­cine, the number of ongoing regenerative medicine trials worldwide has grown to 2 600. 1 320 trials are industry-sponsored by nearly 1 200 companies. 243 of these trails are in Phase 3. As of October 2021, FDA has approved over 20 regene­rative medicine treatments.

Also, according to the alliance, nearly 20 billion USD was invested in regenerative medicine during 2020, widely eclipsing the investments in 2019. With an annual growth rate of 10 – 30 %, market surveys estimate that the global regenerative medicine market has reached a value of up to 150 billion USD by 2028.

Source: Allied Market Research, Marketsand­Markets, Verified Market Research and GrandwiewResearch.

Third Pillar of Healthcare

Pharmaceuticals and surgery have been the two pillars of medical treatment for centuries. As now recognized by Big Pharma, regene­rative medicine is set to become the third pillar of healthcare.

Two images showing cell culturing of today and tomorrow

However, to fulfill its promise of curing a range of common diseases and to make treatment safe and accessible to all, regenerative medicine must transition from a craft (left) to a regulated large-scale industry where cells are grown in clean-rooms without manual handling (right).

Images showing how beer brewing has transitioned from craft to industry
Regenerative medicine will not be the first cell-based process that has made the transition from craft to industry.

Fluorescence Launch

For decades, medical scientists have used fluorescence micro­scopy to study the genetic activity of cells. However, the research community has become increasingly aware that the toxic side-effects created by fluorescence microscopy could lead to misleading results and incorrect con­clu­sions. Academic and commercial scientists are therefore looking for non-invasive alternatives.

To date, there are no good solutions available to this toxicity problem. However, the integration of holo­graphic and fluo­re­scence microscopy in a single instru­ment solves this long-standing issue. By combining the two tech­niques, the number of fluoro­chromes and their use is minimized, reducing the amount of toxin released by the fluorochromes to a minimum.

Brightly colored fluorescent cells
Fluorescent cells can be incredibly beautiful. However, brilliant and beautiful cells often mean dead cells due to the released toxins. Fluorescence images of living healthy cells are mundane and far less cinematic, for a layman.

Presently HoloMonitor addresses a market of well over 100 000 medical research labora­tories. The vast majority of these laboratories use fluorescence today. HoloMonitor’s coming fluorescence capability will significantly strengthen the HoloMonitor product range. The add-on fluorescence unit will allow commercial and academic researchers to use fluorescence more efficiently while reducing the undesired toxic effects of fluorescence imaging.

The yet-to-be-named HoloMonitor fluorescence unit is planned to be launched in the first half of 2022, expanding PHI’s current product line.

HoloMonitor in Regenerative Medicine

The non-invasive qualities of HoloMonitor make it especially well-suited for regenerative medicine appli­cations. As a result, the number of Holo­Moni­tor units that have been purchased for use within regene­rative medicine has increased notably over the past year. The most notable customers within the field are both Bayer AG and its subsidiary BlueRock Thera­peutics. In July this year, BlueRock was granted an FDA Fast Track designation for their cell therapy for advanced Parkinson’s disease.

AI, Fluorescence and Holography

Modern AI software learns by example. Before training begins, a large training dataset is collected where each example is paired with the correct answer. For instance, a training dataset could be images of individual cells paired with the cell type.

The dataset is then presented to a network of digital “brain cells”. Each time the network gives the wrong answer, the network connections are adjusted to provide a more correct answer next time the example is shown to the network. Eventually, the network will learn to give the right answer for all the examples in the dataset.

Minimally invasive fluorescence is essen­tial not only in pre-clinical research but also for identifying cellular transformations when developing biomanufacturing quality and process control standards.

During therapy pro­duction, the patient cells transform from the extrac­ted to the desired cell type in several stages. As the cells will be transplanted back to the patient, it is by no means acceptable to stain or biochemically label the cells to assess the transformation progress.

By combining fluorescence imaging with holo­graphic imaging, an AI-based system may be taught to recognize the intermediate cell types without fluorescence imaging. Each example in the training dataset is created by determining the cell type using fluorescence, while holo­graphic imaging provides the example cell image. Provided there is sufficient discriminating information in the example images, the AI software will learn to recognize cell types without fluorescent labeling to remove the need for fluorescence imaging completely, as desired.

Biomanufacturing Consortium

As previously communicated, we entered a partnership with the Wake Forest Institute for Regenerative Medicine (WFIRM) and its biomanu­facturing scale-up initiative RegenMed Development Organization (ReMDO) in August 2021. At both the federal and state levels in the United States, WFIRM is considered to be the leader of regenerative medicine.

To achieve the goal of industrializing regenerative medicine, WFIRM has identified several tech­nologies that need to be developed, outlined in An Industry-Driven Roadmap for Manufacturing in Regenerative Medicine. WFIRM has further recognized that it cannot develop and promote these technologies on its own. WFIRM has therefore initiated the creation of a stakeholder consortium that brings industry, academia and government agencies together to facilitate regenerative medicine’s transition from craft to industry. PHI’s natural role in the established consortium would be to provide the critical non-invasive cell imaging and analysis technology outlined above.

Peter Egelberg, CEO

Sales

As of last spring, sales have steadily increased. We anticipate that this positive sales trend will continue. However, we expect sales to be temporarily slower when international restrictions are imposed during pandemic surges. But, as we have seen, sales quickly rebound as soon as restrictions once again are lifted.

Rolling 12-month sales with trendline

Net sales and result

Net sales for the second quarter amounted to 1 818 (826) KSEK and operating results before depreciation (EBITDA) to -2 733 (-2 946) KSEK. The net result amounted to -3 901 (-4 777) KSEK.

Investments

With an emphasis on application development and the development of fluorescence capability, the company invested 1 246 (1 048) KSEK in the product, patent, and application development during the period.

Financing

Cash, cash equivalents, and unutilized granted credits amounted to 21 261 (21 595) KSEK by the end of the period. The equity ratio was -13 (62) %.

PHI has secured working capital until 2023. One of the loans from Formue Nord A/S of 20 000 KSEK, of the total approved loan amount of 35 000 KSEK, can be repaid in cash or by debt/equity swap, under certain specific conditions.

Based on that working capital is secured, calculation of the net sales value of inventories and valuation of intellectual property rights, the Board makes the assessment that the share capital is intact and that the company has sufficient working capital.

Risks

The company may be affected by various factors, described in the 2020/21 Annual Report. These factors may individually or jointly increase risks for the operation and result of the company.

Accounting principles

The accounts are prepared in accordance with the Annual Accounts Act and general advice from the Swedish Accounting Standards Board BFNAR 2012:1 Annual accounts and consolidated accounts (K3).

Review

This interim report has not been subject to review by the company’s auditor.

Statements about the future

Statements concerning the company’s business environment and the future in this report reflect the board of director’s current view of future events and financial developments. Forward-looking statements only express the judgments and assumptions made by the board of directors on the day of the report. These statements have been carefully assessed. However, it is brought to the reader’s attention that these statements are associated with uncertainty, like all statements about the future.

Calendar

About PHI

Phase Holographic Imaging (PHI) develops instrumentation and software for time-lapse cytometry. The products are used for long-term quantitative analysis of the dynamics of live cells, particularly significant in the research of cancer, as well as in the treatment of inflammatory and autoimmune diseases. The products are sold globally through the company’s distributors. The company is based in Lund, Sweden, and in Boston, Massachusetts.

On behalf of the Board of Directors
Peter Egelberg, CEO

For additional information please contact:
Peter Egelberg
Tel: +46 703 19 42 74
E-mail: ir@phiab.se
Web: www.phiab.com

Consolidated – PHI Group

Income statement (KSEK)

 Q2Q2YTDYTDFY
2021/222020/212021/222020/212020/21
Net sales1 8188264 1919573 637
Cost of products sold-124-190-1 067-347-1 346
Gross profit1 6946363 1246102 291
Gross margin93%77% 75%64%63%
   
Selling expenses-1 891-1 874-3 961-3 482-8 773
Administrative expenses-1 658-1 025-3 715-3 859-7 084
R&D expenses-1 947-3 041-3 617-6 161-11 720
Operating income052301 7231 972
   
Operating result (EBIT)-3 802-4 781-8 169-11 169-23 314
   
Financial net-994-201-25-195
   
Result before tax (EBT)-3 901-4 777-8 370-11 194-23 509
   
Net Result (EAT)-3 901-4 777-8 370-11 194-23 509

Balance sheet (KSEK)

 Q2Q2FY
2021/222020/212020/21
ASSETS  
Non-current assets  
Intangible assets15 67414 95414 823
Tangible assets235518337
Total non-current assets15 90915 47215 160
  
Current Assets  
Inventory2 4991 6041 334
Short-term receivables3 2112 9812 938
Cash and equivalents1 2618 3452 256
Total current assets6 97112 9306 528
  
Total assets22 88028 40221 688
  
EQUITY AND LIABILITIES  
Equity-3 00417 6755 384
Financial liabilities18 6504 6257 400
Operating liabilities7 2346 1028 904
  
Total equity and liabilities22 88028 40221 688

Changes in equity (KSEK)

 Q2Q2FY
2021/222020/212020/21
Opening Balance89322 47628 896
Equity issues, net  
Net profit-3 901-4 777-23 509
Translation difference4-24-3
Closing balance-3 00417 6755 384
Equity ratio-13%62%25%

Cash flow analysis (KSEK)

 Q2Q2YTDYTDFY
2021/222020/212021/222020/212020/21
Operating activities   
Net result-3 901-4 777-8 370-11 194-23 509
Depreciation9961 8351 9973 6746 541
Translation difference4-24 -27-4
Operating cash flow-2 901-2 966-6 373-7 547-16 972
   
Increase (-)/decrease (+) in inventories-890-211-1 165-74196
Increase (-)/decrease (+) in operating receivables347-824-273-470-348
Increase (+)/decrease (-) in operating liabilities-209-244-1 6701592 882
Change in working capital-752-1 279-3 108-3852 730
   
Cash flow from operating activities-3 653-4 245-9 481-7 932-14 242
   
Investing activities   
Development expenses-1 246-1 048-2 747-1 707-4 091
Patents1010-170
Tangible assets00000
   
Cash flow after investments-4 898-5 293-2 746-9 639-18 503
   
Financing activities   
Net proceeds from equity issues00-1800
Increase (+)/decrease (-) in borrowings-8-25011 2503 500-6 275
   
Cash flow from financing activities-8-25011 2323 5006 275
   
Cash flow for the period-4 906-5 543-995-6 139-12 228
Cash and cash equivalents at the beginning of the period6 16713 8882 25614 48414 484
   
Cash and cash equivalents at the end of the period1 2618 3451 2618 3452 256
Incl. unutilized credits21 26121 59521 26121 56535 506

Data per share

 Q2Q2YTDYTDFY
2021/222020/212021/222020/212020/21
Earnings per Share, SEK-0,27-0,33-0.58-0,78-1,63
Equity per share, SEK-0,211,23-0.211,230,37
Number of Shares, end of period14 394 97114 394 97114 394 97114 394 97114 394 971
Average number of shares14 394 97114 394 97114 394 97114 394 97114 394 971
Share price end of period, SEK23.7527.6023.7527.6025.00

Parent company

Income statement (KSEK)

 Q2Q2YTDYTDFY
 2021/222020/212021/222020/212020/21
Net sales6561 0152 4781 1372 991
Cost of products sold-142-424-1 067-581-1 358
Gross profit5145911 4115561 633
Gross margin78%58%57%49%55%
   
Selling expenses-1 103-1 495-2 522-2 403-6 617
Administrative expenses-1 658-1 025-3 715-3 859-7 084
R&D expenses-1 947-3 041-3 617-6 161-11 720
Other Income052301 7231 972
   
Operating result (EBIT)-4 194-4 447-8 443-10 144-21 816
   
Financial net-994-201-25-1 137
   
Result before tax (EBT)-4 293-4 443-8 644-10 169-22 953
   
Net Result (EAT)-4 293-4 443-8 644-10 169-22 953

Balance sheet (KSEK)

 Q2Q2FY
 2021/222020/212020/21
ASSETS 
Non-current assets 
Intangible assets15 67414 95414 823
Tangible assets235518337
Financial assets09420
Total non-current assets15 90916 41415 160
 
Current Assets 
Inventory2 4991 3371 334
Short-term receivables5 2304 0674 578
Cash and equivalents07 9981 711
Total current assets7 72913 4027 623
 
Total assets23 63829 81622 783
 
EQUITY AND LIABILITIES 
Equity-2 24619 1836 399
Financial liabilities18 6504 6257 400
Operating liabilities7 2346 0088 984
 
Total equity and liabilities23 63829 81622 783