ALVET TheraVet SA

• 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