- Positive safety and efficacy results for BIOCERA-VET®
(arthrodesis and canine osteosarcoma) and VISCO-VET® (canine
osteoarthritis)
- Initiation of the pivotal European multicentric clinical study
evaluating VISCO-VET® in canine osteoarthritis
- Commercialization of BIOCERA-VET® Bone Surgery and BIOCERA-VET®
Osteosarcoma in several European countries
- Strong cash position of €5.63m at December 31, 2021 giving two
years of financial visibility
Regulatory News:
TheraVet (ISIN:
BE0974387194 - ticker: ALVET) (Paris:ALVET) (Brussels:ALVET), a
pioneering company in the management of osteoarticular diseases in
pets, today announces its annual results for the year to
December 31, 2021, provides a business update and confirms its
development and commercial prospects for 2022.
Enrico Bastianelli, Chief Executive Officer of TheraVet,
said: “2021 was a very exciting and fruitful year for the
Company. First the successful Initial Public Offering allowed and
will allow Theravet to pursue its ambitious development program and
notably the development of its 2 product lines, BIOCERA-VET® and
VISCO-VET®. Also, 2021 was a major turning point for the Company
which reached the commercial stage with its bone substitute product
line, BIOCERA-VET®. ”
Full year 2021 financial results
€ (Belgian GAAP)
December - 21
December - 20
Revenue
12,348
0
Other operating income
2,181,390
1,220,017
Stock of finished goods and work
in progress
54,843
0
Produced fixed assets
1,930,219
987,810
Operating grants
54,199
87,815
Other operating income
142,129
144,392
Total operating income
2,193,738
1,220,017
Purchases and expenses
-3,364,356
-1,574,818
COGS
-63,972
0
R&D expenses
-1,152,580
-639,134
IPO exceptional expenses
-174,932
0
Marketing & Sales
expenses
-199,622
-525
G&A expenses
-1.009.862
-465,452
Staff expenses
-762,085
-468,689
Other operating charges
-1,303
-6,115
EBITDA
-1,170,618
-354,801
Depreciation and amortization
-558,294
-46,399
EBIT
-1,728,912
-401,200
Financial income
261,088
12,247
Profit/loss for the period before
taxes
-1,467,824
-388,953
Taxes, Adjustment of income taxes and
write-back of provisions
126,974
490
Net Profit/loss
-1,340,850
-388,463
Net Cash
5,631,418
2,167,462
During 2021, TheraVet generated its first revenues following the
launch of BIOCERA-VET® Bone Surgery in Belgium in April, in France
and the Netherlands in October and of BIOCERA-VET® Osteosarcoma in
December in the same countries.
The Company also generated €1.93 million of “Produced fixed
asset” as a result of the activation of development expenses
related to the BIOCERA-VET® and VISCO-VET® programs.
In accordance with the roadmap presented at the time of the IPO,
the increase in “Purchases and expenses" reflects the development
of preclinical and clinical programs, the commercialization of
BIOCERA-VET® products and the structuring of the Company:
- COGS are counted for the first year:
Increased by €0.06 million as compared to 2020 resulting from the
commercialisation of BIOCERA-VET® products.
- R&D expenses contributed to the
main part of expenses with €1.15 million and increased by €0.51
million as compared to 2020. The increase is mainly the result of
(i) BIOCERA-VET® development with €0.29 million in December 2021
for the validation of the manufacturing process of BIOCERA-VET®
Bone Surgery and for the clinical studies in order to support the
products with safety and efficacy data as compared to €0.26 million
in December 2020 and (ii) VISCO-VET® development with €0.84
millions in December 2021 contributing to preclinical and clinical
developments with the launch of the European pivotal study and the
initiation of the validation of the GMP manufacturing process as
compared to €0.47 million in December 2020.
- IPO exceptional expenses increased
by €0.17 million as compared to 2020 and related to the preparation
of the Initial Public Offering.
- Marketing & Sales expenses
increased by €0.20 million as compared to marginal expenses of 2020
resulting from the effort of the Company to prepare the commercial
launch of the BIOCERA-VET® products.
- G&A expenses increased by €0.54
million as compared to 2020 mainly as a result of
- the effort to increase visibility of the Company to the
investors by participating in financial events or promoting the
Company,
- the lawyers support in the preparation of the different
partnership agreements negotiated and signed over 2021 and early
2022,
- the increase of the operational consultants to structure and
strengthen the Company.
- Staff expenses increased to €0.76
million in December 2021 as compared to €0.47 million as a result
of the structuring of the Company including the recruitment of 7
employees in 2021.
Finally, the amortization of development expenses related to the
BIOCERA-VET® Bone Surgery and VISCO-VET® programs resulted in an
operating loss of €1.7 million and a net loss of €1.34 million.
The Company’s cash and cash equivalents at December 31, 2021
amounted to €5.63 million allowing to fund operation at least until
first quarter of 2024.
Operational highlights (including events after closure of the
financial year)
BIOCERA-VET®, the most comprehensive line of bone
substitutes
2021 was the year of the development of BIOCERA-VET®, TheraVet’s
line of bone substitutes.
Highlights on the R&D
program
The Company announced positive results in the target clinical
indications:
- In July 2021, BIOCERA-VET®
Osteosarcoma was used successfully in a multidisciplinary approach
to the treatment of osteosarcoma in dogs.
- In November 2021, positive safety
and efficacy results of BIOCERA-VET® Osteosarcoma cementoplasty as
a palliative option for canine osteosarcoma were reported with:
- Improvement of quality of life
- Reduction of pain for up to 6 months after the treatment
- Low complication rate
- In February 2022, the positive
safety and efficacy results of BIOCERA-VET® Bone surgery in canine
arthrodesis (fusion of carpal or tarsal joint) were confirmed on an
enlarged cohort of patients (27 dogs). In this study, BIOCERA-VET®
was shown to be at least as effective as autologous bone graft but
with a lower complication rate (0% vs 25%) and a reduced surgery
time (30 to 45 min), positioning BIOCERA-VET® as a valuable
alternative to the reference procedure. Results were presented and
awarded by the “Best Poster Presentation” in February 2022 at an
American world-class orthopedic conference, Veterinary Orthopedic
Conference (VOS).
Highlights on commercialization
The commercialization of BIOCERA-VET® Bone Surgery was initiated
in April 2021 in Belgium, and extended to France and the
Netherlands in October 2021. BIOCERA -VET® Osteosarcoma was
launched in December 2021 in the same countries.
Commercial expansion was pursued in March 2022 with the launch
in the United Kingdom and Ireland, representing the 3rd biggest
companion animal market in Europe with more than 16 millions
dogs.
In January 2022, in order to support the Company in sales and
according to the Company’s strategy, TheraVet signed a distribution
agreement with Centravet, one of France’s leading
wholesaler/distributor of animal health products.
Highlights on the partnership
agreements
To build the most comprehensive line of vet bone substitutes ,
the Company signed two additional major partnerships :
- In November 2021, signing of an
exclusive distribution and research partnership with INNOTERE Gmbh
(Germany) significantly expanding TheraVet’s synthetic bone
substitutes portfolio with (i) 2 complementary bone graft lines,
(ii) 3D-bioprinted bone endoprostheses for patient-tailored bone
grafting surgeries & (iii) the development of novel generation
proprietary products.
- In February 2022, signing of an
exclusive partnership with Industrie Biomediche Insubri SA (IBI,
Switzerland) on a new biological bone graft product line,
“BIOCERA-VET® SmartGraft”; in order to provide the veterinary
market with a unique and standardized biological bone graft
solution combining quality and availability.
With these new partnerships, the Company has built one of the
most comprehensive lines of bone substitutes available in the
veterinary market.
VISCO-VET®, a new solution in canine osteoarthritis
and prevention of ligament rupture
VISCO-VET® is a line of injectable intra-articular gels
addressing dog articular diseases such as osteoarthritis and
cranial cruciate ligament deficiencies, representing more than 40
millions patients in Europe and the United States.
In September 2021, laboratory proof-of-concept results
were confirmed in a pilot clinical study evaluating VISCO-VET® in
canine osteoarthritis in client-owned dogs. A single
intra-articular injection of VISCO-VET® provided:
- A statistically significant improvement in dog’s mobility
- A statistically significant reduction in dog’s
osteoarthritis-related pain
- Long-lasting effects, and increasing over time, for up to 3
months after the injection
- Well tolerated with no adverse event reported
The Company announced in September 2021 the launch of the
pivotal European multicentric clinical study evaluating VISCO-VET®
in canine osteoarthritis in France and the Netherlands. Patient
enrolment started in October 2021.
Strategy & key milestones in 2022
In 2022, the Company intends to continue the development of its
various assets and accelerate the ramping up of the
commercialization of BIOCERA-VET®. The resources will be allocated
to achieving the following strategic objectives:
- Launch of BIOCERA-VET® line in the United States of America and
in Germany (the biggest companion animal market in Europe),
respectively during the first and second half of 2022
- Initiation of the pivotal European multicentric clinical
evaluating VISCO-VET® in canine osteoarthritis in Poland and
Portugal anticipated in first semester 2022
- Continuation of the discussion with Regulatory Agencies in
Europe and the United States in the preparation of the regulatory
filing of VISCO-VET®
Annual Report 2021
The 2021 annual report ending December 31, 2021 will be
published April 07, 2022 and will be available on the Company’s
website, www.theravet-finances.com. The accounting data reported in
this press release are consistent in all material respects with the
financial statements audited by The Company’s statutory auditor,
PricewaterhouseCoopers (PWC) Réviseurs d’Entreprise SRL and derived
from the annual accounts.
Financial calendar 2022
Ordinary General Assembly : June 02, 2022
Half-year business update : June 30, 2022
About TheraVet SA TheraVet is a veterinary biotechnology
company specialising in osteoarticular treatments for companion
animals. The Company develops targeted, safe and effective
treatments to improve the quality of life of pets suffering from
joint and bone diseases. For pet owners, the health of their pets
is a major concern and TheraVet’s mission is to address the need
for innovative and curative treatments. TheraVet works closely with
international opinion leaders in order to provide a more effective
response to ever-growing needs in the field of veterinary medicine.
TheraVet is listed on Euronext Growth® Paris and Brussels, has its
head office in Belgium (Gosselies) with a US subsidiary in Texas.
For more information, visit the TheraVet website Or follow us on
LinkedIn / Facebook / Twitter
Forward-looking statements
This release may contain forward-looking statements.
Forward-looking statements may include statements regarding the
Company's plans, objectives, goals, strategies, future events, the
safety and clinical activity of TheraVet’s pipelines and financial
condition, results of operation and business outlook. By their
nature, forward-looking statements involve inherent risks and
uncertainties, both general and specific, and there are risks that
predictions, forecasts, projections and other forward-looking
statements will not be achieved. These risks, uncertainties and
other factors include, among others, those listed and fully
described in the “Risk Factors” section in the Annual Report.
TheraVet expressly disclaims any obligation to update any such
forward-looking statements in this document to reflect any change
in its expectations with regard thereto or any change in events,
conditions or circumstances on which any such statement is based,
unless required by law or regulation.
Statements of operations and comprehensive loss
31.12.2021
31.12.2020
Operating
2.193.738
1.220.017
Turnover
12.348
Stocks of finished goods and work and
contracts in progress: increase (decrease)
54.843
Produced fixed assets
1.930.219
987.810
Other operating income
196.327
232.207
Non-recurring operating charges
Operating charges
3.922.649
1.621.217
Goods for resale, raw materials and
consumables
63.972
Purchases
206.459
Stock: increase/decrease
-142.487
Services and other goods
2.536.995
1.100.015
Remuneration, social security costs and
pensions (+)/(-)
762.085
468.689
Amortisations of and other amounts written
down on formation expenses, intangible and tangible fixed
assets
558.294
46.399
Increase, decrease in amounts written off
stocks contracts in progress and trade debtors : appropriations
(write-backs) … (+)/(-)
Provisions for risks and charges -
appropriations (uses and write-backs) … (+)/(-)
Other operating charges
1.303
6.115
Operation charges carried to assets as
restructuring costs
Non-recurring operating charges
Operating profit (loss) (+)/(-)
-1.728.912
-401.200
31.12.2021
31.12.2020
Financial income
310.197
37.146
Recurring financial income
310.197
37.146
Income from financial fixed assets
9.481
9.019
Other financial income
300.716
28.126
Non-recurring financial income
Financial charges
49.109
24.899
Recurring financial charges
49.109
24.899
Interest and other debt charges
26.452
21.591
Other financial charges
22.657
3.308
Non-recurring financial charges
Profit (loss) for the period before
taxes (+)/(-)
-1.467.824
-388.953
Transfer from postponed taxes
Transfer to postponed taxes
Income taxes (+)/(-)
-126.974
-490
Taxes
2.596
Adjustment of income taxes and write-back
of provisions
129.570
490
Profit (loss) for the period
(+)/(-)
-1.340.850
-388.463
Transfer from untaxed reserves
Transfer to untaxed reserves
Profit (loss) for the period available
for appropriation (+)/(-)
-1.340.850
-388.463
Statement of Financial Position
ASSETS
31.12.2021
31.12.2020
FIXED ASSETS
4.476.838
2.759.657
Formation expenses
818.975
0
Intangible fixed assets
4.263.509
2.572.374
Tangible fixed assets
29.841
24.600
Land and buildings
Plant, machinery and equipment
20.401
23.076
Furniture and vehicles
9.440
1.524
Leasing and other rights
Other tangible fixed assets
Tangible assets under construction and
advance payments made
Financial fixed assets
183.489
162.683
Affiliated companies
171.564
Participating interests
8.749
Amounts receivable
162.815
Other financial fixed assets
11.925
Amounts receivable and cash guarantees
11.925
CURRENT ASSETS
6.155.650
2.350.911
Amounts receivable after more than one
year
Trade debtors
Other amounts receivable
Stocks and contracts in
progress
197.330
Stocks
197.330
Raw materials and consumables
25.607
Work in progress
45.576
Finished goods
9.268
Goods purchased for resale
116.880
Contract in progress
Amounts receivable within one
year
279.243
90.863
Trade debtors
6.916
12.032
Other amounts receivable
272.327
78.831
Current investments
Cash at bank and in hand
5.631.418
2.167.461
Deferred charges and accrued
income
47.659
92.587
TOTAL ASSETS
11.451.463
5.110.567
LIABILITIES
31.12.2021
31.12.2020
EQUITY
9.647.627
3.391.683
Contributions
10.172.459
3.119.953
Issued capital
322.394
248.930
Uncalled capital
Share premium account
9.850.065
2.871.023
Revaluation surplus
Reserves
Legal reserve
Reserve not available
In respect of own shares held
Others
Untaxed reserves
Available reserves
Accumulated profits (+)/ losses
(-)
-1.956.667
-615.817
Investment grants
1.431.835
887.547
PROVISIONS AND DEFERRED TAXES
Provisions for liabilities and
charges
Deferred taxes
AMOUNT PAYABLE
1.803.836
1.718.884
Amounts payable after more than one
year
909.568
699.100
Financial debts
909.568
699.100
Subordinated loans
62.500
Other loans
847.068
699.100
Trade debts
Advances received on contracts in
progress
Other amounts payable
Amounts payable within one year
884.468
1.011.465
Current portion of amounts payable after
more than one year
92.055
Financial debts
Credit institutions
Other loans
Trade debts
540.165
285.097
Suppliers
540.165
285.097
Bills of exchange payable
Advances received on contracts in
progress
Taxes, remuneration and social
security
173.004
120.218
Taxes
16.674
2.341
Remuneration and social security
156.330
117.877
Other amounts payable
79.245
606.150
Accruals and deferred income
9.800
8.319
TOTAL LIABALITIES
11.451.463
5.110.567
Cash Flow Statement
Cash flow Statement
31.12.2021
31.12.2020
Free cashflow
-869.908
-326.797
Net cash used in operations
-339.325
970.612
Net cash (used in)/from investing
activities
-3.094.450
-1.111.090
Net cash (used in)/from financing
activities
7.767.640
2.553.307
Net cash (decrease)/increase
3.463.956
2.086.032
cash & cash equivalents at
opening
2.167.461
81.429
cash & cash equivalents at
closing
5.631.418
2.167.461
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220405006042/en/
TheraVet Chief Operating Officer Sabrina Ena
investors@thera.vet Tel: +32 (0) 71 96 00 43
Chief Corporate Officer Julie Winand investors@thera.vet
NewCap Investor Relations and Financial Communications
Théo Martin / Olivier Bricaud theravet@newcap.eu Tel: +33 (0)1 44
71 94 94
Press Relations Arthur Rouillé / Ambre Delval theravet@newcap.eu
Tel: +33 (0)1 44 71 00 15
NewCap Belgique Press Relations Laure-Eve Monfort
lemonfort@newcap.fr Tél. : + 32 (0) 489 57 76 52
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