TruScreen Results Half Year Ended 30 September 2020
Template
Results announcement
(for Equity Security issuer/Equity and Debt Security issuer)
Updated as at 17 October 2019
Results for announcement to the market
Name of issuer Truscreen Group Limited
Reporting Period 6 months to 30 September 2020
Previous Reporting Period 6 months to 30 September 2019
Currency
Amount (000s) Percentage change
Revenue from continuing
operations
$597 (22%)
Total Revenue $991 (47%)
Net profit/(loss) from
continuing operations
($1,510) (48%)
Total net profit/(loss) ($1,510) (48%)
Interim/Final Dividend
Amount per Quoted Equity
Security
The Company does not propose to pay a dividend
Imputed amount per Quoted
Equity Security
N/A
Record Date N/A
Dividend Payment Date N/A
Current period Prior comparable period
Net tangible assets per
Quoted Equity Security
$0.0176 $0.0151
A brief explanation of any of
the figures above necessary
to enable the figures to be
understood
For commentary on the results please refer to the commentary
on the related NZX Release.
Authority for this announcement
Name of person
authorised
to make this announcement
Guy Robertson (Chief Financial Officer)
Contact person for this
announcement
Guy Robertson (Chief Financial Officer)
Contact phone number +61 407 983 270
Contact email address guyrobertson@truscreen.com
Date of release through MAP
4 November 2020
Unaudited financial statements accompany this announcement.
---
TRUSCREEN GROUP LIMITED
(formerly Truscreen Limited)
Interim Unaudited Financial Statements
For the Six Months Ended 30 September 2020
TRUSCREEN GROUP LIMITED
Table of contents
Page
Operations report 1
Consolidated statement of profit or loss and other comprehensive income 3
Consolidated statement of financial position 4
Consolidated statement of changes in equity 5
Consolidated statement of cash flows 6
Notes to the interim unaudited condensed financial statements 7
TRUSCREEN GROUP LIMITED
1
OPERATIONS REPORT
Cervical cancer screening technology company, TruScreen Group Limited (NZX: TRU) (Company), is pleased to
provide the unaudited financial results for the six months to 30 September 2020 (1H 2021).
The Company reported a bottom-line loss of $1.5m (2019: $1.0m). The major contributor to that loss was a reduction
of $0.7m in the Australian research and development tax offset refund. The 2019 result included the impact of share-
based payments of $0.3m attributable to that half-year (1H) period.
Product revenue at $0.6m (2019: $0.76m) is down 22% on the prior year. Note that the 2019 period benefitted from
sales to Zimbabwe of $0.28m billed and shipped in Financial Year (FY) 2018. However, the application of NZ IFRS
15 required that this be recognised as sales on receipt of cash early in FY 2019. On a shipped and billed basis, sales
are up 24%, and Single Use Sensor (SUS) revenues grew 85% on the prior period. SUS sales by volume shipped
increased by 80% year on year (YOY), largely attributable to China.
Net operating cash outflow was $1.6m (1H 2019: $1.7m). Cash operating costs were 5% lower in the six months, at
$1.8m (1H 2019: $1.9m). The loss for the six months included a non-cash amortisation and depreciation charge of
$0.35m (1H 2019: $0.30m).
At 30 September 2020, the Company had cash and cash equivalents of $4.47m. A capital raise of $4.97m (net of
costs) was completed in April/May 2020. The capital raising was undertaken via a successful Share Purchase Plan
and a private placement.
Half-Year Commentary
TruScreen continued to make significant commercial progress in the six months to 30 September 2020,
notwithstanding the challenges presented by COVID-19.
The Company continues to apply appropriate Occupational Health and Safety protocols to protect staff, our suppliers,
and consultants. The TruScreen team continue to work effectively between home and the office at the Commonwealth
Scientific and Industrial Research Organisation (CSIRO), Lindfield. NSW.
Market development
China, our largest market, after an early lockdown was the first country to lift COVID-19 restrictions and has
recovered well. Our distributor has added installed devices to new hospitals in the Municipality of Shanghai,
Provinces of Sichuan, Hunan, Guangdong, Shandong, Jiangsu, Guangxi, Shan’xi, and Guizhou, increasing the
number of in-use TruScreen cervical cancer screening devices from 49 to 69 over the course of the half-year. SUS
sales to China have increased by 80% YOY. Unfortunately, this positive improvement has been offset by the negative
impact of COVID-19 restrictions in Russia and Zimbabwe, and a hiatus in Mexico prior to the appointment of a
replacement distributor.
After four years of market development, in April 2020 TruScreen received approval from the Ministry of Health
(MOH) of the Vietnam Government for the commercial rollout of the TruScreen cervical cancer screening device.
This followed a MOH-managed clinical trial which compared TruScreen to a Pap test and covered 989 patients. The
trial was concluded successfully, with a positive clinical outcome at the Hanoi Obstetrics & Gynaecology Hospital.
The positive trial results in Vietnam were further confirmed by preliminary trial results in Sichuan Province, China,
covering 1,243 patients in 14 hospitals. The Sichuan trial results were better than, or at least on parity with, tests for
HPV (Human Papillomavirus DNA Test) and LBC (Liquid-based Cytology). The Sichuan trial results were
presented by the lead investigator of the China Obstetrics and Gynaecology Association (COGA) project in Sichuan
Province, at COGA’s annual congress in September 2020.
TRUSCREEN GROUP LIMITED
2
Operations
The Company has strengthened its executive team with the following appointments:
- Edmond Capcelea as Chief Technology Officer. Edmond has more than 20 years’ experience in medical design
and development. Edmond holds a Master’s Degree in Engineering Physics, and his previous roles include
Divisional Director Head of Implants and Design Development at Cochlear Limited, and Senior Vice President
of Research and Development at Saluda Medical.
- Dr Beata Edling MD, Phd, MBA as Medical Affairs Lead. Beata’s previous roles include Executive Medical
Director Amgen, Eli Lily, and Sanofi.
- Jerome Villalon as Senior Software Engineer. Jerome holds a Bachelor’s Degree in Information
Communications Technology from UTS.
Further product research and development is continuing to be undertaken, with particular focus on reducing the cost
of manufacture of both the TruScreen cervical cancer screening device and SUS. These projects, should they prove
successful, should result in improved gross margins in calendar 2021 and beyond.
As announced in early 2020, the Company proposes to relocate its device manufacturing for the China market to
Shenzhen, China. Planning for the project has commenced. This will provide TruScreen greater access to the China
market where the public health system gives preference to locally manufactured product. Subject to COVID-19
restrictions, this is scheduled to be operational by 30 June 2021.
During 1H, we have improved our commercial support to our distribution network. Several key projects were initiated
in these areas to improve our capabilities to support product rollout and a higher number of installed devices active
in the field across the globe.
We have completed development of an online training platform available to end-users. The platform hosts our
recently developed training video and theory exam and will accompany on-patient training provided by our
distributors. We have also expanded our cloud-based Jira service system to enable distributors to use the portal to
provide feedback on device performance, update service records, and track location of the devices.
Highlights for HY2020:
• Operational SUS sales volume growth of +80% over 1H 2019;
• Expansion in China, with installed devices in new hospitals increased by 40% YOY;
• Expansion into Vietnam with MOH approval, and first shipment of product;
• Appointment of distributors in Eastern Europe, Aspironix s.r.o and MPG d.o.o Beograd for the Balkans;
• Appointment of replacement distributor in Mexico, Sunbird S.A. de C.V.; and
• Successful $5.243m (before costs) capital raising completed in May/June 2020.
Corporate
The Company appointed Victoria Potarina, an executive with more than 18 years’ experience at Johnson & Johnson
(J & J) and other blue-chip multinational companies in FMCG, OTC, medical devices and healthcare, as CEO on 2
March 2020.
Prof Ron Jones and Mr Con Hickey retired as Directors on 31 March 2020 and 10 September 2020, respectively. Ms
Juliet Hull was elected a Director on 10 September 2020. Ms Hull is the NZ General Manager/Country Director of
Johnson & Johnson Medical, a Director of the ANZ Johnson & Johnson Medical Executive Board, a Director of
MTANZ (Medical Technology Association of NZ) and a member of both the APAC Regional Leadership team for
J & J’s Orthopaedics and Ethicon Divisions.
Thanks to the strong support of shareholders, the Company raised $5.243m before costs in April/May 2020. A Share
Purchase Plan raised $3m through the issue of 74,860,021 shares at 5 cents each, and a further $2.243m was raised
through an over-subscribed placement of 30,000,000 shares at 5 cents each.
Anthony Ho
Chairman
4 November 2020
TRUSCREEN GROUP LIMITED
3
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
AND OTHER COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2020
Unaudited
for the six
months
ended 30
September
2020
Restated
Unaudited
for the six
months
ended 30
September
2019
Audited
for the year
ended 31 March
2020
Note $
$ $
Revenue from the sale of goods 596,824
762,110 1,288,242
Other income 4 394,199
1,110,993 1,266,040
Changes in inventories -
3,011
960
Purchases of inventory (351,272)
(366,424)
(772,980)
Employee benefit expenses and directors’ fees (644,236)
(715,432)
(1,308,222)
Administration (244,927)
(222,223)
(541,663)
Research and development expenses (524,718)
(524,823)
(1,137,389)
Travel (1,598)
(72,047)
(77,777)
Marketing & product approvals (284,811)
(134,119)
(430,656)
Insurance (39,840)
(48,445)
(87,410)
Shareholder relations & services (35,362)
(136,570)
(148,115)
Foreign exchange gain/(loss) 3,970
-
108,038
Amortisation & depreciation (346,192)
(304,886)
(597,830)
Impairment of non-current assets 4 -
-
(2,380,000)
Finance costs (32,202)
(60,319)
(71,959)
Share based payments -
(306,000)
(306,000)
Loss before income tax (1,510,165)
(1,015,174)
(5,196,721)
Income tax expense -
-
-
Loss for the period after income tax (1,510,165)
(1,015,174)
(5,196,721)
Other comprehensive income
Item that may be reclassified subsequently to
profit or loss
Exchange gain/(loss) on translating foreign
subsidiary operations 448,242
(145,940)
(259,903)
Other comprehensive income/(loss) for the period
448,242 (145,940) (259,903)
Total comprehensive loss for the period
(1,061,923) (1,161,114) (5,456,624)
Basic and diluted losses (cents per share) (0.48)
(0.46)
(2.32)
The accompanying notes form part of these financial statements.
TRUSCREEN GROUP LIMITED
4
CONSOLIDATED STATEMENT OF FINANCIAL POSITION
AS AT 30 SEPTEMBER 2020
Unaudited
30 September
2020
Unaudited
30 September
2019
Audited
31 March
2020
Note $ $ $
CURRENT ASSETS
Cash and cash equivalents 4,467,663 990,821 1,024,153
Trade receivables 156,924 480,947 107,018
Other receivables 923,419 1,987,743 684,250
Loan receivable 75,000 75,000 75,000
Goods and services taxes recoverable 37,249 34,224 17,510
Inventories 610,774 797,985 503,768
Other assets – prepayments 293,620 181,395 136,442
TOTAL CURRENT ASSETS 6,564,649 4,548,115 2,548,141
NON-CURRENT ASSETS
Plant and equipment 314,042 345,314 295,048
Intangible assets 5,292,643 8,102,857 5,230,821
TOTAL NON-CURRENT ASSETS 5,606,685 8,448,171 5,525,869
TOTAL ASSETS 12,171,334 12,996,286 8,074,010
CURRENT LIABILITIES
Trade and other payables 447,951 636,798 293,141
Borrowings 436,840 626,501 410,280
Employee benefits 88,531 138,895 83,149
TOTAL CURRENT LIABILITIES 973,322 1,402,194
786,570
NON-CURRENT LIABILITIES
Employee benefits 49,375 57,515
46,373
TOTAL NON-CURRENT LIABILITIES 49,375 57,515
46,373
TOTAL LIABILITIES 1,022,697 1,459,709 832,943
NET ASSETS 11,148,637 11,536,577 7,241,067
EQUITY
Issued capital 8 32,461,543 27,492,050 27,492,050
Share option reserve 306,000 306,000 306,000
Foreign currency translation reserve (266,457) (600,736) (714,699)
Accumulated losses (21,352,449) (15,660,737) (19,842,284)
Total Equity 11,148,637 11,536,577 7,241,067
The accompanying notes form part of these financial statements.
TRUSCREEN GROUP LIMITED
5
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2020
Share
Capital
Accumulated
Losses
Foreign
Currency
Translation
Reserve
Option
Reserve Total
Note $
$
$
$
$
Balance at 31 March 2020
(Audited)
27,492,050 (19,842,284)
(714,699)
306,000 7,241,067
Comprehensive income
Loss for the period ended 30
September 2020
- (1,510,165) - - (1,510,165)
Other comprehensive loss
for the period
- - 448,242 - 448,242
Total comprehensive loss
for the period (unaudited)
- (1,510,165) 448,242 - (1,061,923)
Transactions with owners
Issue of shares 8
5,243,001 - - - 5,243,001
Share issue costs 8
(273,508) - - - (273,508)
Total transactions with
owners
4,969,493 - - - 4,969,493
Balance at 30 September
2020 (Unaudited)
32,461,543
(21,352,449)
(266,457)
306,000
11,148,637
Balance at 31 March 2019
(Audited)
26,421,168 (14,645,563)
(454,796)
- 11,320,809
Comprehensive income
Loss for the period ended 30
September 2019 - restated
- (1,015,174) - - (1,015,174)
Other comprehensive loss
for the period
- - (145,940) - (145,940)
Total comprehensive loss
for the period (unaudited) -
restated
- (1,015,174) (145,940) - (1,161,114)
Transactions with owners
Issue of shares 8
1,131,800 - - - 1,131,800
Share issue costs 8
(60,918) - - - (60,918)
Share based payments -
restated
- - - 306,000 306,000
Total transactions with
owners
1,070,882 - - 306,000 1,376,882
Balance at 30 September
2019 (Unaudited) - restated
27,492,050
(15,660,737)
(600,736)
306,000
11,536,577
The accompanying notes form part of these financial statements.
TRUSCREEN GROUP LIMITED
6
CONSOLIDATED STATEMENT OF CASH FLOWS
FOR THE SIX MONTHS ENDED 30 SEPTEMBER 2020
Unaudited
for the six
months
ended 30
September
2020
Unaudited
for the six
months
ended 30
September
2019
Audited for
the year
ended 31
March 2020
Note $
$
$
CASH FLOW FROM OPERATING
ACTIVITIES
Cash receipts from customers 561,141 506,468
1,309,080
Cash paid to suppliers and employees (2,067,640) (2,179,539)
(4,415,470)
Cash received from research and development tax
offset
-
-
1,645,985
Short-term lease payments not included in lease
liability
(34,136)
-
(111,002)
Interest paid (32,202) (60,317)
(71,959)
Interest received - 3,272
8,867
Net cash used in operating activities 9
(1,572,837) (1,730,116) (1,634,499)
CASH FLOW FROM INVESTING
ACTIVITIES
Purchase of plant and equipment (74,064) - -
Net cash used in investing activities (74,064) - -
CASH FLOW FROM FINANCING
ACTIVITIES
Proceeds from issue of shares 5,243,001 1,131,800 1,131,800
Share issue costs (273,508) (60,918) (60,918)
Proceeds from borrowings - - 410,280
Repayment of borrowings - - (626,501)
Net cash provided by financing activities
4,969,493 1,070,882 854,661
Net increase/(decrease) in cash and cash
equivalents
3,322,592 (659,234) (779,838)
Cash and cash equivalents at beginning of period 1,024,153 1,737,775
1,737,775
Effect of foreign exchange adjustment on cash
balances
120,918 (87,720)
66,216
Cash and cash equivalents at end of period 4,467,663 990,821 1,024,153
The accompanying notes form part of these financial statements.
TRUSCREEN GROUP LIMITED
7
1. REPORTING ENTITY
TruScreen Group Limited (the “Company”) is a Tier 1 for-profit listed incorporated public company and is
an issuer on the New Zealand Stock Exchange (“NZX”). The Company is a limited liability company
incorporated and domiciled in New Zealand and registered under the Companies Act 1993. The NZX
ticker code for TruScreen is TRU. TruScreen is an FMC reporting entity for the purposes of the Financial
Reporting Act 2013 and the Financial Markets Conduct Act 2013.
The Group’s principal activity relates to the research & development and manufacture of cancer detection
devices and systems.
The consolidated unaudited interim condensed financial statements presented for the six months ended 30
September 2020 are those of TruScreen Group Limited and its subsidiaries (the “Group”). References to
“TruScreen” are used to refer both to the Group and TruScreen Group Limited (the “Company”).
The Company changed its name to TruScreen Group Limited (formerly TruScreen Limited) on 21 August
2020.
These consolidated unaudited interim financial statements were authorised for issue by the Board of
Directors on 4 November 2020.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PREPARATION
These financial statements are unaudited and have been prepared in accordance with New Zealand
Generally Accepted Accounting Practice (“NZ GAAP”) and part 7 of the Financial Markets Conduct Act
2013. The financial statements comply with NZ IAS 34: Interim Financial Reporting and International
Accounting Standards IAS 34: Interim Financial Reporting.
The consolidated unaudited interim financial statements have been prepared in New Zealand dollars, which
is the presentation currency, with the New Zealand dollar and the Australian dollar being the functional
currency of the New Zealand parent company and the Australian subsidiary respectively. These financial
statements do not include all the information required for full financial statements and consequently should
be read in conjunction with the Group’s financial statements for the year ended 31 March 2020.
The same accounting policies have been followed in these financial statements as were applied in the
preparation of the Group’s audited financial statements for the year ended 31 March 2020.
The consolidated unaudited interim financial statements are prepared on the basis of historical cost, except
where otherwise identified.
3. CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS
When preparing the interim financial statements, management is required to make judgements, estimates
and assumptions about carrying values of assets and liabilities that are not readily apparent from other
sources. The estimates and associated assumptions are based on experience and other factors that are
believed to be reasonable under the circumstances. Actual results may differ from the estimates, judgements
and assumptions made by management. Estimates and underlying assumptions are reviewed on an on-going
basis. Revisions to accounting estimates are recognised in the period in which the estimate is revised and
in any future periods affected. Information about significant areas of estimation uncertainty and critical
judgements in applying accounting policies that have the most significant effect on the amounts recognised
in the financial statements can be found in the previous annual report.
SEASONALITY
Operations are not subject to seasonal influences.
TRUSCREEN GROUP LIMITED
8
4. SIGNIFICANT TRANSACTIONS AFFECTING NET LOSS
Significant transactions affecting net loss
The following significant items affecting the unaudited loss for the period are highlighted below because
of their size:
Unaudited
for the six
months
ended 30
September
2020
Unaudited for
the six months
ended 30
September
2019
Audited for
the year
ended 31
March 2020
$ $ $
Other income
Research and development tax offset¹
- Current year
185,506 365,085 684,250
- Prior year adjustment
53,663 572,923 572,923
239,169 938,008 1,257,173
Interest
919 3,204 8,867
Government subsidies
154,111 - -
Foreign exchange gains - unrealised
- 169,781 -
Total other income
394,199 1,110,993 1,266,040
Expense
Impairment²
- - 2,380,000
¹Ongoing Research & development is being conducted in the following areas:
• Clinical trials;
• Software & firmware improvements incorporated from feedback on prototypes to improve usability;
• Manufacturing processes of the electrical and optical assembly;
• Changes and improvements to the electrical and optical assembly; and
• Further work on developing and testing the algorithm.
²The Directors undertook a comprehensive Impairment Review (“Review”) of the intangible assets of the
Company as at the 31 March 2020 year end. This Review was undertaken in compliance with NZ IAS 36
Impairment (‘IAS 36’) and its detailed specifications with the assistance of an independent consultant.
In particular, the Directors assessed the risk of not meeting the projected device sales and rollout in China
and other countries as a result of COVID-19 pandemic. These risks were taken into account in determining
the budget for 2021 and the impact on sales revenue in subsequent years.
A further limited review was undertaken at the 30 September 2020 half year. The current 2021 forecast is
under the budget projected in March 2020 due to COVID-19 impact. However, this may not have a material
impact on the carrying value of intangible assets at 31 March 2021, and a full determination will be made
as at this date. The Company’s business in the key market of China, impacted early in calendar 2020 by
COVID-19 and the first country to lift COVID-19 restrictions, has made a strong recovery.
TRUSCREEN GROUP LIMITED
9
5. ADMINSTRATION AND OTHER OPERATING EXPENSES
The following commentary explains the improvement in cash administration and operating expenses over
the previous half year:
Clinical trials – lower level of support activity in 1H 2020 partly attributable to COVID-19;
Research and development – 1H 2019 includes support expenditure relating to a pilot plant;
Travel – no travel in 1H 2020 attributable to COVID-19. This inability to meet with distributors is a limiting
factor in the short term; and
Share-based payments – the prior period contains a share-based payment charge of $306,000 relating to
Director and Officer options issued on 24 September 2019. As the options had vested, they were fully
expensed in that period.
6. OPERATING SEGMENTS
The Group operates in one operating segment. It owns the rights to the TruScreen Cervical Cancer
Screening System. The system comprises a medical device and process designed to detect the presence in
real time of precancerous and cancerous tissue on the cervix.
The Group earns revenue largely from China, with developing markets in South East Asia, Russia, Mexico,
India, and Eastern Europe. Revenues are from sales to the Company’s distributors (indirect channel of
distribution).
Two major customers each contributed more than 10% of the Group’s revenue in the six months to 30
September 2020 (2019: two customers):
• One customer provided revenue of $508,712 (85%); and
• One customer provided revenue of $88,154 (15%).
No additional disclosure is required in the interim financial statements as the Group has one reportable
segment.
7. RESTATEMENT OF PRIOR PERIOD
The results for the half year ended 30 September 2019 have been restated to include a one-off charge of
$306,000 being 9,000,000 unlisted options issued to Directors and Officers on 24 September 2019. The
options which were fully vested have an exercise price of 15 cents per share with an expiry date of 27
August 2022.
8. SHARE CAPITAL
No. $
Balance at 30 September 2019 227,535,804 27,492,050
Balance at 31 March 2020 227,534,804 27,492,050
Share Purchase Plan, 21 May 2020 74,860,021 3,743,001
Share placement, 29 May and 5 June 2020 30,000,000 1,500,000
Share issue costs - (273,508)
Balance at 30 September 2020 332,394,825 32,461,543
TRUSCREEN GROUP LIMITED
10
9. RECONCILIATION OF CASH FLOW FROM OPERATING ACTIVITIES
Unaudited
for the six
months
ended 30
September
2020
Restated
Unaudited
for the six
months
ended 30
September
2019
Audited for
the year
ended 31
March 2020
$ $ $
Reconciliation of cash flow from operations with
loss after income tax
Loss for the period (1,510,165)
(1,015,174)
(5,196,721)
Adjusted for:
Amortisation and depreciation 346,192 304,886 597,830
Impairment of non-current assets - - 2,380,000
Share based payment expense - 306,000 306,000
Exchange difference arising from translating loss
items at the date of transaction and translating cash
balances at period end rates 943 (170,220)
(188,764)
Operating cash flows before working capital changes (1,163,030) (574,508) (2,101,655)
(Increase)/decrease in trade receivables (49,906) (293,443) 80,486
(Increase)/decrease in goods and services taxes
recoverable (19,739)
(3,889)
12,826
Increase in prepayments (157,178) (159,843) (114,890)
(Increase)/decrease in inventory (107,006) (15,959) 278,258
Increase/(decrease) in research and development
refundable tax offset (239,169)
(917,226)
386,267
Increase/(decrease) in trade and other payables 154,806 199,766 (143,889)
Increase in employee liabilities 8,385 34,986 (31,902)
Net cash outflow from operating activities
(1,572,837)
(1,730,116)
(1,634,499)
TRUSCREEN GROUP LIMITED
11
10. NET TANGIBLE ASSETS PER SHARE
Unaudited
as at
30 September
2020
Unaudited
as at
30 September
2019
Audited
as at
31 March
2020
Net tangible assets ($) 5,855,994 3,433,720 2,010,246
Shares on issue at the end of period 332,394,825 227,534,804 227,534,804
Net tangible assets per share (cents per
share)
1.76
1.51
1.13
11. CONTINGENT LIABILITIES
There are no contingent liabilities in this or the previous reporting period.
12. EVENTS SUBSEQUENT TO END OF THE INTERIM PERIOD
The Company repaid a loan of $436,840 in October 2020.
Except for the above and as outlined in the Corporate section of the Half-Yearly Operations Report, there
have been no other events since 30 September 2020 which would have a material effect on the Group’s
unaudited interim financial statements for the six months ended 30 September 2020.
---
NZX Announcement
4 November 2020
TruScreen Unaudited Preliminary Results for the Half-Year ended 30 September 2020
Highlights for HY2020:
✓ Operational SUS sales volume growth of +80% over 1H 2019;
✓ Expansion in China, with installed devices in new hospitals up 40% YOY;
✓ Expansion into Vietnam with MOH approval, and first shipment of product;
✓ Appointment of distributors in Eastern Europe, Aspironix s.r.o and MPG d.o.o Beograd for
the Balkans;
✓ Appointment of replacement distributor in Mexico, Sunbird S.A. de C.V.; and
✓ Successful $5.243m (before costs) capital raising completed in May/June 2020.
Cervical cancer technology company TruScreen Group Limited (NZX: TRU) (the Company,
TruScreen) announces its preliminary unaudited half-yearly results for the period ended 30
September 2020. TruScreen continued to make commercial progress throughout the period.
Unaudited Preliminary Half-Yearly Financial Results for the period ended 30 September 2020
(1H 2021)
The Company reported a bottom-line loss of $1.5m (2019: $1.0m). The major contributor to that
loss was a reduction of $0.7m in the Australian research and development tax offset refund. The
2019 result included the impact of share-based payments of $0.3m attributable to that half-year
(1H) period.
Product revenue at $0.6m (2019: $0.76m) was down 22% on the prior year. Note that the 2019
period benefitted from sales to Zimbabwe of $0.28m billed and shipped in Financial Year (FY)
2018. However, the application of NZ IFRS 15 required that this be recognised as sales on receipt
of cash early in FY 2019. On a shipped and billed basis, sales were up 24%, and Single Use Sensor
(SUS) revenues grew 85% on the prior period. SUS sales by volume shipped increased by 80%
year on year (YOY), largely attributable to China.
Net operating cash outflow was $1.6m (1H 2019: $1.7m). Cash operating costs were 5% lower
in the six months, at $1.8m (1H 2019: $1.9m). The loss for the six months included a non-cash
amortisation and depreciation charge of $0.35m (1H 2019: $0.30m).
At 30 September 2020, the Company had cash and cash equivalents of $4.47m. A capital raise of
$4.97m (net of costs) was completed in April/May 2020. The capital raising was undertaken via a
successful over-subscribed Share Purchase Plan and a private placement.
Operational update
TruScreen continued to make significant commercial progress in the six months to 30 September
2020, notwithstanding the challenges presented by COVID-19.
• China screening continues to produce outstanding results
The China Obstetrics and Gynaecology Association’s (COGA) ongoing national clinical trial that
originally planned to screen over 20,000 women has been reduced to 10,000 patients due to
interruptions from COVID-19 lockdowns. The COGA trial is being conducted in 100 top-tier public
hospitals across 10 provinces in China. The trial is comparing the TruScreen’s technology to Liquid
Based Cytology (LBC), and HPV DNA testing (HPV). This large-scale trial is targeting as the main
outcome a nationwide consensus on the application of TruScreen’s technology in China.
Preliminary trial results from Sichuan Province were presented by the lead investigator of the
COGA project in Sichuan Province, at COGA’s annual congress in September 2020. The Sichuan
trial covered 14 hospitals and 1,243 patients in the data analysis.
The preliminary results from the Sichuan Province trial were better than, or at least on parity
with, tests for HPV (Human Papillomavirus DNA Test) and LBC (Liquid-based Cytology). These
results confirm trial results from Hunan Province that were announced in 2019.
TruScreen’s China distributor has increased the number of in-use TruScreen cervical cancer
screening devices from 49 to 69 over the course of the half-year, adding new hospitals in the
Municipality of Shanghai and the Provinces of Sichuan, Hunan, Guangdong, Shandong, Jiangsu,
Guangxi, Shan’xi, and Guizhou.
• Vietnam – Approval from Vietnam Government’s Ministry of Health (MOH)
After a successful clinical trial covering 989 patients, the Company received approval from the Ministry
of Health (MOH) of the Vietnam Government for the commercial rollout of the TruScreen cervical cancer
screening device.
This landmark approval is granted initially for the Hanoi Obstetrics and Gynaecology Hospital
(HOGH). It is anticipated that further rollouts across other public and private hospitals in Vietnam
will occur this financial year.
• Distributor development
Prominent medical device distributor Aspironix s.r.o (Aspironix) was appointed exclusive
distributor for the Czech Republic, Slovakia, and Poland. These countries have a combined
cervical cancer addressable screening population of over 17.91 million women, presenting a
significant market opportunity for the Company.
A further distributor, MPG d.o.o Beograd, was appointed with responsibility for Serbia,
Montenegro, Bosnia, and Macedonia.
• Corporate
Capital Raise
With the strong support of shareholders, the Company raised $5.243m before costs in April/May
2020, with a Share Purchase Plan raising $3m through the issue of 74,860,021 shares at 5 cents
each and a further $2.243m through an over-subscribed placement of 30,000,000 shares at 5
cents each.
Enhanced Team Capability
The Company appointed Victoria Potarina, an executive with more than 18 years’ experience at
Johnson & Johnson (J & J) and other blue-chip multinational companies in FMCG, OTC, medical
devices and healthcare, as CEO on 2 March 2020.
The team was further strengthened during 1H 2021 with the appointment of;
Edmond Capcelea as Chief Technology Officer. Edmond holds a Master’s Degree in Engineering
Physics, and his previous roles include Divisional Director Head of Implants and Design
Development at Cochlear Limited, and Senior Vice President of Research and Development at
Saluda Medical. TruScreen also appointed
Dr Beata Edling MD, PhD, MBA as Medical Affairs Lead. Beata’s previous roles include Executive
Medical Director Amgen, Eli Lily, Sanofi.
Jerome Villalon as Senior Software Engineer. Jerome holds a Bachelor’s Degree in Information
Communications Technology from UTS.
Outlook
TruScreen’s goals for FY 2021 and beyond:
• Achieve >160 commercially installed devices across key markets by March 2021 (+100%
on 2020)
• Target COGA consensus in China on TruScreen as a primary cervical cancer screening tool
• Increase commercial coverage in Russia, following COVID-19 recovery
• Achieve China manufacture for China TruScreen device requirements
• Through research and development and process optimisation reduce cost of production
of both the TruScreen device and SUS
• Expand market presence in Eastern Europe
Commenting on the outlook, TruScreen CEO Victoria Potarina said,
“In the last 6 months Truscreen has advanced substantially in it’s transformational phase. The
reinforced team has identified a number of key projects which will give us greater access to the
China market, improve the Company’s gross margin and optimise our go to market capabilities.
Our results this half year have been impacted by COVID-19, nonetheless Truscreen has a solid
growth plan which is expected to build sustainable SUS revenue streams from diverse markets
over the medium term once the COVID-19 effect subsides”.
- ENDS -
For more information, visit www.TruScreen.com or contact:
TruScreen
Victoria Potarina
CEO
victorinapotarina@truscreen.com
TruScreen
Guy Robertson
CFO
guyrobertson@truscreen.com
Investors
Investor Relations
Phone: +61 2 9237 2801
TruScreen@we-buchan.com
About TruScreen:
TruScreen’s cervical cancer screening device offers the latest technology in cervical screening,
providing real-time, accurate detection of pre-cancerous and cancerous cervical cells to help
improve the health and well-being of women around the world.
TruScreen’s real-time cervical cancer technology utilises a digital wand which is placed on the
surface of the cervix to measure electrical and optical signals from the surrounding tissues. A
sophisticated proprietary algorithm framework is utilised to detect pre-cancerous change, or
cervical intra-epithelial neoplasia (CIN), by optical and electrical measurement of cervical tissue.
TruScreen offers an alternative approach to cervical screening, resolving many of the ongoing
issues with conventional Pap tests, including failed samples, poor patient follow-up, patient
discomfort and the need for supporting laboratory infrastructure. As such, TruScreen’s target
market is low- and middle-income countries where no large-scale cervical cancer screening
programs and infrastructure are in place, such as China, Mexico, Africa, Russia, and India.
TruScreen’s cervical cancer screening device is CE-marked and certified for use throughout
Europe and NMPA (previously CFDA) approved for sale in China. The global market potential for
TruScreen is significant.
Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.