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Vivesto — Interim / Quarterly Report 2022
Nov 17, 2022
3124_10-q_2022-11-17_3863869f-9dbe-438e-8fab-0c59878f683a.pdf
Interim / Quarterly Report
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Vivesto AB (publ)
Interim report for the period January 1, 2022 – September 30, 2022
SIGNIFICANT EVENTS DURING THE THIRD QUARTER
- In July Christer Nordstedt was appointed acting CEO.
- In July Vivesto announced that the company has decided to wind down its activities in Russia following the Russian invasion of Ukraine, ongoing hostilities and international sanctions. The wind down of Vivesto's activities in Russia means that a write down of SEK 44.6 million is carried out during the third quarter of 2022, equal to the net book value of the capitalized development costs for Paclical® after amortization as of June 30, 2022.
- In August, Vivesto's and Elevar's partner Inceptua began the commercial launch of Apealea® in Germany.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
• In November Vivesto announced that the acting CEO Christer Nordstedt had resigned from his position in order to assume a new role outside of the company. Christer Nordstedt will remain as senior advisor to Vivesto on a consultancy basis within R&D.
THIRD QUARTER: JULY 1, 2022 – SEPTEMBER 30, 2022
- Consolidated net sales amounted to TSEK 1,015 (11,920)
- Operating profit/loss was TSEK 71,318 (-29,572)
- Write-down of development costs attributable to Russia TSEK -44,624 (0)
- Operating profit/loss adjusted for write-down of development costs attributable to Russia TSEK -26,694 (-29,572), a decrease of SEK 2,878
- Net profit/loss after tax amounted to TSEK -71,682 (-30,987)
- Earnings per share amounted to SEK -0.14 (-0.07)
THE PERIOD: JANUARY 1, 2022 – SEPTEMBER 30, 2022
- Consolidated net sales amounted to TSEK 1,015 (16,553)
- Operating profit/loss was TSEK -133,970 (-126,579)
- Write-down of development costs attributable to Russia TSEK -44,624 (0)
- Operating profit/loss adjusted for write-down of development costs attributable to Russia TSEK -89,346 (-126 579), a decrease of SEK 37,233
- Net profit/loss after tax amounted to TSEK -136,653 (-129,873)
- Earnings per share amounted to SEK -0.28 (-0.29)
- Short-term investments, cash and cash equivalents amounted to TSEK 164,241 (149,677)
- Equity/assets ratio was 95% (80%)
ACTING CEO REVIEW
Immediately after I took over as acting CEO at Vivesto in July, I began a thorough review of the entire business. All of Vivesto's assets and projects have been reviewed and evaluated from both a scientific and financial perspective. Our work is currently focused on three main areas: to further strengthen the research portfolio, to increase the value of existing projects and technology platforms, and to further trim our costs in order to be able to use a greater part of our resources to build and run our research portfolio.
After the initial review, it is clear that, just as previously assumed, our formulation technology should be able to be used with significantly more drugs than just paclitaxel. As part of the work to strengthen Vivesto's research portfolio, we have identified a number of different substances, with patent protection, or without patent protection, so-called
generic substances, which could be formulated with our technology and offer patients important treatment benefits.
Within modern pharmaceutical chemistry, a strong trend has been seen for several years towards new molecules becoming larger and more difficult to dissolve than before. These molecules often have higher specificity and effect, that is, they are more effective than previous generations of drug substances. In addition, they often address a new category of targets previously unknown to science, or previously not considered possible to develop into useful drugs. I am convinced that Vivesto's formulation technology can be valuable for numerous molecules that today cannot be used due to lack of solubility, including molecules with remaining patent protection. We will therefore systematically, with the help of artificial intelligence, neural networks and other applicable technology, search for such opportunities with the aim of establishing collaborations with other pharma companies. In this way, we could grow our portfolio with more value-generating projects and strengthen Vivesto's position as a drug developer.
Our existing development projects and products form the basis of Vivesto, and we work intensively to increase the value of existing assets. There are several ways to increase the value of a project/molecule. The clinical plan is reviewed continuously with the aim of finding out whether it is possible to make minor changes in study setup or study design to strengthen the chances of success or shorten the time to market-approved drug. Another way is to evaluate the substance within other indications in order to broaden the target group and increase the future market potential. We are currently working on both of these strategies for our clinical cancer program Cantrixil and hope to strengthen the value of the project in this way.
Another high-priority area for Vivesto is to build a larger and stronger IP portfolio around our proprietary formulation technology. It was therefore very satisfying that we in September were able to submit a patent application for the XR-18 to the Swedish Patent and Registration Office.
As previously announced, our market-approved product Apealea was launched in Germany in August this year. The launch took place through our partner Elevar and its European partner Inceptua. This is an important milestone as it is the first time that Apealea has been launched commercially in a larger market. We are in close contact with Elevar to follow how sales develop in Germany and how the launch plans progress in other markets. We cannot provide any sales figures at this time, but we hope to be able to do so during the first half of 2023.
In addition, we can also report that the investigator-initiated phase 1b study evaluating Docetaxel micellar in patients with metastatic prostate cancer, conducted in Switzerland by the Swiss Group for Clinical Cancer Research (SAKK), continues to enroll patients. More than half of the patients are included and according to SAKK's assessment the recruitment can be completed during the next year. Results are expected in 2024.
Vivesto has previously received a conditional approval in the USA for the veterinary drug Paccal Vet, our formulation of paclitaxel for the treatment of cancer in dogs. For strategic reasons, the process was not completed, and the drug was therefore withdrawn from the market. The market for companion animals is now facing rapid growth, while there are currently very few approved drugs for cancer in dogs. With a solid research foundation and significant in-house expertise in the field, we are reviewing the possibilities of continuing development in veterinary medicine and, if deemed appropriate, preparing for further studies in selected indications.
During the roughly four months I have been acting CEO at Vivesto, I have gained a very good insight into the company's operations. I am impressed by the development work that is being carried out and I see significant potential in both the company's assets and its dedicated employees. The role as acting CEO has always been intended to be of a temporary nature and at the end of November I will move on to a new position outside of the company. I now look forward to continuing to contribute to Vivesto's development as a senior advisor within R&D on a consulting basis.
Christer Nordstedt, acting CEO of Vivesto
ABOUT VIVESTO
Vivesto is an oncology-focused specialty pharmaceutical company that develops new treatment options for patients suffering from difficult-to-treat cancer. The company has a portfolio of projects targeting innovative cancer treatments and the capacity to develop drugs from early research to regulatory approval. Late clinical-phase and commercial development is carried out individually or in partnership with other pharmaceutical companies.
Apealea® (paclitaxel micellar) is being made available to ovarian cancer patients through a partnership with Elevar Therapeutics, Inc. Development programs include Cantrixil, in clinical development for late-stage ovarian cancer, and docetaxel micellar, in development for advanced prostate cancer. Vivesto has developed proprietary drug delivery technologies designed to improve solubility of various active pharmaceutical ingredients.
Vivesto's shares are traded on Nasdaq Stockholm (VIVE). To find out more about Vivesto please visit www.vivesto.com.
TECHNOLOGY PLATFORMS
The foundation for Vivesto is the proprietary drug delivery technology XR-17TM, a technology platform that can improve aqueous solubility for intravenous active pharmaceutical ingredients to improve their efficacy and safety. The technology has been successfully applied when developing Vivesto's most advanced product, Apealea. Development is currently ongoing for developing the next-generation drug delivery platform, XR-18.
XR-17TM Technology
XR-17 is Vivesto's proprietary drug delivery technology and is based on a blend of two isomers of a synthetic derivative of vitamin-A acid (XMeNa and 13XMeNa), which can solubilize compounds with poor aqueous solubility, such as paclitaxel. XR-17 demonstrates amphiphile properties since its molecules contain both hydrophilic and hydrophobic structural regions. As a result, XR-17 molecules can spontaneously form nanosized structures, known as micelles, within aqueous environments. During the process hydrophobic substances are dissolved in the XR-17 micelles.
XR-18 Technology
When developing Apealea and other projects using the XR-17 technology platform, Vivesto has built up valuable knowledge and understanding of how solubility and drug delivery can be improved in pharmaceutical molecules with solubility and delivery challenges. Based on this experience, Vivesto is developing the next generation of drug delivery technology, XR-18, which is an expanded and improved version of the XR-17 technology.
XR-18 is currently in an early development phase and has delivered promising results so far in terms of formulations employing new APIs. In early 2022, Vivesto announced that progress had been made in the internal development of XR-18 and that the company had identified and formulated promising compounds for further development. A patent application is filed for XR-18.
Exploratory Research
Vivesto is engaged in a project to investigate the biologic effects of its product candidates and technology platform variants, XR-17 and XR-18, leading to the quantification of cellular effects on target cells, initially in cancer indications, to create a screening tool for future development. This project is currently carried out with Visikol, Inc. in the USA and Vivesto hope to report new developments in the future.
PRODUCTS & PROJECT PORTFOLIO
Vivesto has a portfolio of projects in clinical and commercial phases that are intended to treat latestage, hard-to-treat cancer. The drug Apealea was developed for patients with ovarian cancer and is scheduled to be launched in selected European markets under Inceptua's responsibility. Vivesto's development program includes Cantrixil, a clinical cancer program, and Docetaxel micellar for metastatic prostate cancer.
Apealea
Apealea (paclitaxel micellar) is a patented solvent-free formulation: it applies paclitaxel – a cornerstone within chemotherapy for many different forms of cancer – through Vivesto's XR-17 technology platform. Apealea is approved by the European regulatory authority, the EMA, for use in combination with carboplatin for the treatment of adult patients with first relapse of platinumsensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Apealea has also received orphan drug designation from the US regulatory authority FDA for the treatment of epithelial ovarian cancer, which could entail several potential benefits, including seven years of market exclusivity.
Status of partnerships
Elevar
Vivesto signed a global strategic partnership with US-based Elevar Therapeutics for the commercialization of Apealea in March 2020. Elevar has signed a license agreement with Inceptua Group for the commercialization of Apealea in Europe.
In December 2021 the transfer of the marketing authorization for Apealea from Vivesto to Inceptua was approved by from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
In August 2022 Inceptua announced that they had launched Apealea in Germany.
FarmaMondo
In September 2021, Vivesto entered into an agreement with the Swiss FarmaMondo for commercialization purposes of Paclical (Apealea) in Russia and CIS countries. Following the Russian invasion of Ukraine, ongoing hostilities and international sanctions, Vivesto has decided to wind down its activities in Russia. This means that the distribution activities for Paclical (Apealea) in Russia and CIS countries are paused until further notice.
Cantrixil
Cantrixil is a clinical-stage product that consists of the active molecule, a potent and selective third generation benzopyran SMETI inhibitor named TRXE-002-01, encapsulated in a cyclodextrin. It is believed to target a wide spectrum of cancer cells, including chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse.
Status
An upcoming clinical trial with Cantrixil is being prepared and Vivesto is currently working with clinical and regulatory experts to design the trial. The first part of this work was developing testing material for the coming clinical trials. In March, Vivesto announced that the company had signed a large-scale manufacturing agreement with Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, for the main drug intermediate in the supply of clinical material for Cantrixil.
Docetaxel micellar
Docetaxel micellar is a product candidate in early clinical development and is a novel formulation that combines XR-17 with docetaxel – a well-established cytotoxin, currently administered intravenously and containing ethanol. In June 2020, Vivesto partnered with the Swiss Group for Clinical Cancer Research (SAKK) with the aim of conducting the first clinical study on the treatment of metastasized prostate cancer with Vivesto's Docetaxel micellar formulation.
Status
Docetaxel micellar is being evaluated in an instigator-initiated Phase 1b trial in patients with metastasized prostate cancer. In February Vivesto announced that the first patient had fully completed the study. About half of the patients are now recruited to the study and recruitment is expected to be completed in H1 2023.
VETERINARY MEDICINE
Vivesto's product candidates within veterinary medicine use the XR-17 technology platform to facilitate the administration of intravenously delivered solvent-free active pharmaceutical ingredients. Vivesto is currently evaluating strategic/commercial alternatives for the company's assets within veterinary medicine operations.
Paccal Vet
Paccal Vet utilizes Vivesto's formulation of paclitaxel with its XR-17 encapsulation technology for the treatment of canine mastocytoma. Vivesto intends to carry out a study together with reputable experts in the field in order to evaluate the possibilities for further development of Paccal Vet.
Doxophos Vet
Doxophos Vet is a patented formulation of doxorubicin, one of the most efficacious and widely used chemotherapeutic substances for the treatment of cancer. Vivesto has developed Doxophos Vet for the treatment of lymphoma, one of the most frequent forms of canine cancer. Pre-clinical and earlier clinical studies have been conducted on dogs with cancer. In the first attempt, Doxophos Vet showed promising efficacy against hematological tumors. The development program is currently on hold, awaiting further strategic decisions.
FINANCIAL INFORMATION
Condensed consolidated income statement
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| TSEK | Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec |
| Net sales | 1,015 | 11,920 | 1,015 | 16,553 | 26,192 |
| Operating profit/loss | -71,318 | -29,572 | -133,970 | -126,579 | -128,647 |
| Profit/loss for the period | -71,682 | -30,987 | -136,653 | -129,873 | -132,722 |
| Earnings per share before and after dilution, SEK | -0.14 | -0.07 | -0.28 | -0.29 | -0.30 |
THIRD QUARTER
July 1 – September 30, 2022
Net sales
Net sales amounted to TSEK 1,015 (11,920) and comprised sales of goods for TSEK 1,015 (11,883) and licensing revenues of TSEK 0 (37).
Other operating income
Other operating income amounted to TSEK 113 (4,354) and comprised other operating income of TSEK 60 (-322), foreign exchange gains of TSEK 53 (125) and the proceeds of last year's liquidation of the subsidiary AdvaVet of TSEK 0 (4,551).
Operating profit/loss for the quarter
The operating loss for the quarter amounted to TSEK -71,318 (-29,572). The year-on-year difference in operating profit/loss was largely attributable to the write-down of the company's operations in Russia, which amounted to TSEK -44,624. Operating profit/loss for the quarter after adjustment for this write-down was TSEK -26,694, a year-on-year improvement of TSEK 2,878. The difference pertained primarily to lower employee benefit expenses.
The change in inventories of products in progress and finished goods amounted to TSEK -886 (- 12,237).
Raw materials and consumables TSEK 0 (69).
Other external expenses amounted to TSEK -14,079 (-15,998).
Employee benefit expenses amounted to TSEK -6,624 (-10,396). The number of employees at the end of the quarter was 17 (26).
Depreciation, amortization and impairment amounted to TSEK -50,857 (-7,284), of which the increase is attributable to the write-down of operations in Russia.
Net financial items for the quarter
Net financial items for the quarter of TSEK -364 (-1,415) consisted of financial income amounting to TSEK 26 (459) and financial expenses of TSEK -390 (-1,874).
The financial income comprised capital gains on short-term investments of TSEK 26 (109) and interest income from current financial receivables of TSEK 0 (350).
Financial expenses consisted of value changes in short-term investments of TSEK -275 (0), interest expenses attributable to other borrowings and credits of TSEK 0 (-1,728), exchange losses on cash and cash equivalents of TSEK -20 (-3) and interest expenses from leases of TSEK -95 (-143).
Profit/loss before tax for the quarter
Profit/loss before tax amounted to TSEK -71,682 (-30,987). The year-on-year decrease was largely attributable to the write-down of the company's operations in Russia of TSEK -44,624, see above.
Income tax
Reported income tax for the quarter was TSEK 0 (0).
Profit/loss for the quarter
The net loss after tax was TSEK -71,682 (-30,987).
Cash flow and capital expenditure
Net cash flow for the quarter was TSEK 688 (3,264) and consisted of Cash flow from operating activities of TSEK -22,591 (-25,328), Cash flow from investing activities of TSEK 24,752 (29,990) and Cash flow from financing activities of TSEK -1,473 (-1,398).
Cash flow from operating activities
The cash flow from operating activities for the quarter was TSEK -22,591 (-25,328). The improvement in cash flow was attributable to improved earnings and a net improvement in working capital of TSEK -1,443.
Cash flow from investing activities
Cash flow from investing activities for the quarter was TSEK 24,752 (29,990).
Investments in property, plant and equipment and in intangible assets
Capital expenditure during the quarter consisted of investments in property, plant and equipment of TSEK 248 (10).
Divestment of short-term investments
During the quarter, short-term fixed-income funds amounting to TSEK 25,000 (30,000) were divested. These flows are reported in the cash flow statement as divestment of short-term investments.
Cash flow from financing activities
The cash flow from financing activities amounted to TSEK -1,473 (-1,398) and comprised amortization of lease liabilities of TSEK 1,473 (1,398). Amortization of lease liabilities primarily comprised rental payments which were recognized as amortization pursuant to IFRS 16.
THE PERIOD
January 1 – September 30, 2022
Net sales
Net sales amounted to TSEK 1,015 (16,553) and comprised sales of goods for TSEK 1,015 (16,442) and licensing revenues of TSEK 0 (111).
Other operating income
Other operating income amounted to TSEK 2,284 (6,631) and comprised insurance compensation of TSEK 1,125 (0), disposal of equipment of TSEK 384 (20), recharged costs of TSEK 0 (1,863), other operating income of TSEK 453 (0) and foreign exchange gains of TSEK 322 (197). The year-on-year difference was attributable to proceeds TSEK 0 (4,551) from the liquidation of the subsidiary AdvaVet in 2021.
Operating profit/loss for the period
The operating loss for the period amounted to TSEK -133,970 (-126,579). The year-on-year difference in operating profit/loss was largely attributable to the write-down of the company's operations in Russia, which amounted to TSEK -44,624. Operating profit/loss for the period after adjustment for this write-down was TSEK -89,346, a year-on-year improvement of TSEK 37,233. The difference largely comprised last year's write-down of goods in an amount of TSEK 17,448 as a result of expired shelf lives as well as lower other external expenses and lower employee benefit expenses.
The change in inventories of products in progress and finished goods amounted to TSEK -1,879 (- 34,970).
Other external expenses of TSEK -43,587 (-59,940) decreased TSEK 16,353, mainly due to lower consultancy fees and legal fees, the latter stemming from concluded legal proceedings.
Employee benefit expenses amounted to TSEK -26,424 (-33,008). The number of employees at the end of the quarter was 17 (26).
Depreciation, amortization and impairment amounted to TSEK -65,378 (-21,603), which included the write-down of capitalized development costs in Russia of TSEK -44,624.
Net financial items for the period
Net financial items for the period of TSEK -2,683 (-3,294) consisted of financial income amounting to TSEK 234 (2,453) and financial expenses of TSEK -2,917 (-5,747). The financial income comprised capital gains on short-term investments of TSEK 234 (1,405) and interest income from current financial receivables of TSEK 0 (1,048). Financial expenses consisted of value changes in short-term investments of TSEK -2,516 (0), interest expenses attributable to other borrowings and credits of TSEK 39 (5,086), exchange losses on cash and cash equivalents of TSEK 38 (286) and interest expenses from leases of TSEK 324 (375).
Profit/loss before tax for the period
Profit/loss before tax amounted to TSEK -136,653 (-129,873). The year-on-year decrease was largely attributable to the write-down of the company's operations in Russia of TSEK -44,624, see above.
Income tax
Reported income tax for the period amounted to TSEK 0 (0).
Profit/loss for the period
The net loss after tax was TSEK -136,653 (-129,873).
Cash flow and capital expenditure
Net cash flow for the period was TSEK -4,165 (-33,920) and consisted of Cash flow from operating activities of TSEK -59,101 (-100,429), Cash flow from investing activities of TSEK -75,277 (70,891) and Cash flow from financing activities of TSEK 130,213 (-4,382).
Cash flow from operating activities
Cash flow from operating activities for the period was TSEK -59,101 (-100,429). The TSEK 41,328 improvement in cash flow was primarily attributable to the improved operating profit/loss after adjustment for the write-down of capitalized development costs in Russia of TSEK -44,624.
Cash flow from investing activities
Cash flow from investing activities for the period was TSEK -75,277 (70,891) and pertained to investments in short-term fixed-income funds of TSEK -120,000 (0) from the funds raised in this year's new share issue of TSEK 134,258 and to the divestment of TSEK 45,000 (105,000) in the period. The fund shares can be converted into cash within a few banking days.
Investments in property, plant and equipment and in intangible assets
Capital expenditure during the period consisted of investments in property, plant and equipment of TSEK -277 (-873) and investments in intangible assets of TSEK 0 (-33,236).
The preceding year's investments in intangible assets consisted of license rights pertaining to the global development and commercialization for Cantrixil – a clinical-stage ovarian cancer program. The agreement was the first step in Vivesto's strategy to reach critical mass in its oncology portfolio.
Short-term investments
During the period, short-term fixed-income funds amounting to TSEK 45,000 (105,000) were divested. These flows are reported in the cash flow statement as divestment of short-term investments.
Cash flow from financing activities
The cash flow from financing activities amounted to TSEK 130,213 (-4,382) and comprised new share issues of TSEK 150,652 (0) gross, issue expenses of TSEK -16,394 (0) and amortization of lease liabilities of TSEK -4,045 (-4,382). Amortization of lease liabilities primarily comprised rental payments which were recognized as amortization pursuant to IFRS 16.
Financing and financial position
Cash and cash equivalents
The Group's cash and cash equivalents at the end of the period amounted to TSEK 2,400 (7,185).
Short-term investments
The company's liquidity surplus was invested in short-term fixed-income funds. The fund shares can be converted into cash within a few banking days. As of September 30, 2022, the value of the funds was TSEK 161,841 (142,492).
Other borrowings
In accordance with IFRS 16 Leases, the Group recognizes the present value of future lease payments as interest-bearing liabilities. At the end of the period, the reported lease liabilities amounted to TSEK 5,879 (12,117), of which long-term liabilities were TSEK 3,442 (5,988).
Bank overdraft facility
The Parent Company has an unutilized bank overdraft facility amounting to TSEK 5,000 (5,000).
Equity
At the end of the period, equity amounted to TSEK 545,495 (552,069), the equity/assets ratio was 95% (80), and the debt/equity ratio was negative (negative). The reason that the debt/equity ratio is negative is that net debt is negative, meaning that the sum of cash and cash equivalents and shortterm investments is greater than borrowing.
On March 25, Vivesto announced the final result of the company's fully underwritten rights issue. 48,367,120 shares, corresponding to approximately 53.9% of the shares offered, were subscribed for by the exercise of subscription rights. 1,519,430 shares, corresponding to approximately 1.7% of the shares offered, were subscribed for without the use of subscription rights. The remaining 39,787,359 shares offered, corresponding to approximately 44.4%, have been allotted to underwriters. The rights issue raised proceeds of approximately TSEK 150,652 for the company before issue expenses of TSEK 16,394, resulting in net additional capital of TSEK 134,258. As of March 31, the additional capital strengthened Equity as follows: Share capital TSEK 8,968 and Other capital provided TSEK 125,291. The issue proceeds and the majority of the issue expenses were settled during the period.
Warrants and other instruments outstanding that can increase the number of shares in Vivesto
| No. of options |
Max. No. of shares |
Subscription price, interval | ||
|---|---|---|---|---|
| Warrants which can be converted to three shares | 1,280,250 | 3,840,750 | 4.06 | USD |
| Employee stock options which can be converted to one share | 450,000 | 450,000 | 1.45 | SEK |
| Max. No. of shares | 450,000 |
Warrants which can be converted to three shares refer to warrants issued in 2015 with a maturity date of October 28, 2025. One warrant gives one right to subscribe for three shares at the subscription price of USD 4.06.
The Extraordinary General Meeting on May 25, 2022, approved an employee stock option program directed to senior executives. The program encompasses not more than 2,700,000 options, of which 450,000 have been issued to individuals in senior positions. These options entitle, after vesting in accordance with the terms and conditions, the participant to subscribe for an equal number of shares at an exercise price of SEK 1.45 during the period from and including July 1, 2024 until and including
September 30, 2025 subject to the precondition that the holder remains in the company's employ for three years.
During the period, the individuals in senior positions who received options pursuant to the previous option program announced that their employment at the company had ceased, forfeiting their options and terminating the program. This entailed a negative impact of TSEK 1,798 on equity.
Legal information and additional information
As regards the company's legal proceedings, nothing of material import has taken place during the period.
War in Ukraine
On February 24, 2022, Russia launched a military invasion of Ukraine. The situation in Eastern Europe has led to a great deal of volatility in the global economy and the global credit markets, which can have a negative impact on Vivesto in both the short and long term. On July 5, 2022, Vivesto announced that the company had decided to wind down its activities in Russia following the Russian invasion of Ukraine, ongoing hostilities and international sanctions. This means that the distribution activities for Paclical® (Apealea®) in Russia and the Commonwealth of Independent States (CIS) will be paused until further notice (for more information, refer to Other customer contracts on page 64 of the 2021 Annual Report). It is unclear if, and if so when, commercialization for Paclical® (Apealea) can begin again in these markets. There is also a risk that the situation in Eastern Europe will affect other markets where Vivesto is active, particularly if the conflict escalates further, continues for a long period of time or spreads to other countries. However, the business impact is difficult to predict due to uncertain market conditions. The wind down of Vivesto's activities in Russia means that a write down of MSEK 44.6 has been carried out in the third quarter (July 2022), equal to the net book value of the capitalized development costs for Paclical® after amortization as of June 30, 2022.
Parent Company
The Parent Company's net sales for the period amounted to TSEK 1,015 (16,553) and profit/loss before tax was TSEK -136,602 (-134,274). As of September 30, 2022, the Parent Company's cash and cash equivalents amounted to TSEK 2,400 (7,185) and short-term investments, which within a few banking days can be converted into cash, amounted to TSEK 161,841 (142,492).
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec | |
| No. of shares at end of period, before and after dilution, thousand |
538,043 | 448,370 | 538,043 | 448,370 | 448,370 |
| Weighted average No. of shares, before and after dilution, thousand |
517,390 | 448,370 | 493,207 | 448,370 | 448,370 |
| Earnings per share before and after dilution, SEK | -0.14 | -0.07 | -0.28 | -0.29 | -0.30 |
| Equity per share, SEK | 1.01 | 1.23 | 1.01 | 1.23 | 1.23 |
| Equity/assets ratio, % | 95 | 80 | 95 | 80 | 92 |
| Net liability, TSEK | -164,241 | -69,677 | -164,241 | -69,677 | -97,268 |
| Debt/equity ratio, % | neg. | neg. | neg. | neg. | neg. |
| Return on total assets, % | neg. | neg. | neg. | neg. | neg. |
| Return on equity, % | neg. | neg. | neg. | neg. | neg. |
| Number of employees at period end | 17 | 26 | 17 | 26 | 22 |
Key metrics and other information
Definitions
Earnings per share: Income for the period attributable to the Parent Company shareholders in relation to the weighted average number of shares, before and after dilution, in the period.
Equity per share: Equity attributable to Parent Company shareholders as a ratio of the number of shares at the end of the period.
Equity/assets ratio: Equity as a ratio of total assets.
Net liability: Total borrowings (including the balance-sheet items: liabilities to credit institutions, convertible debt instruments and other borrowings) with deduction of cash and cash equivalents and short-term investments. Lease liabilities calculated in accordance with IFRS 16 are not included in net liability.
Debt/equity ratio: Net liability as a ratio of equity.
Return on total assets: Income before deduction of interest expenses as a ratio of average total assets.
Return on equity: Earnings before taxes as a ratio of average equity.
The key definitions found above are generic definitions often used in analyses and comparisons between different companies. They are therefore given to enable the reader to rapidly and summarily evaluate Vivesto's financial situation and possibly compare with other companies. These have been calculated as follows:
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec | |
| Equity per share | |||||
| Equity attributable to Parent Company shareholders | 545,494 | 552,069 | 545,494 | 552,069 | 549,713 |
| at the end of the period, TSEK | |||||
| No. of shares at end of period, thousand | 538,043 | 448,370 | 538,043 | 448,370 | 448,370 |
| Equity per share, SEK | 1.01 | 1.23 | 1.01 | 1.23 | 1.23 |
| Equity/assets ratio | |||||
| Equity at end of period, TSEK | 545,494 | 552,069 | 545,494 | 552,069 | 549,713 |
| Total assets at end of period, TSEK | 573,236 | 693,303 | 573,236 | 693,303 | 594,308 |
| Equity/assets ratio | 95% | 80% | 95% | 80% | 92% |
| Net liability, TSEK | |||||
| Other borrowings | – | 80,000 | – | 80,000 | – |
| Total borrowings | – | 80,000 | – | 80,000 | – |
| Short-term investments | 161,841 | 142,492 | 161,841 | 142,492 | 89,357 |
| Cash and cash equivalents | 2,400 | 7,185 | 2,400 | 7,185 | 7,912 |
| Total short-term investments, and cash and cash equivalents |
164,241 | 149,677 | 164,241 | 149,677 | 97,269 |
| Net liability | -164,241 | -69,677 | -164,241 | -69,677 | -97,269 |
| Debt/equity ratio | |||||
| Net liability, TSEK | -164,241 | -69,677 | -164,241 | -69,677 | -97,269 |
| Equity, TSEK | 545,494 | 552,069 | 545,494 | 552,069 | 549,713 |
| Debt/equity ratio | -30% | -13% | -30% | -13% | -18% |
| Return on total assets | |||||
| Income before deduction of interest expenses | -71,292 | -29,113 | -133,736 | -124,126 | -126,188 |
| Average total assets | 633,270 | 792,525 | 583,772 | 778,422 | 728,925 |
| Return on total assets | -11% | -4% | -23% | -16% | -17% |
| Return on equity | |||||
| Profit/loss before tax | -71,682 | -30,987 | -136,653 | -129,873 | -132,722 |
| Average equity | 548,782 | 567,371 | 547,603 | 616,133 | 614,955 |
| Return on equity | -13% | -5% | -25% | -21% | -22% |
Consolidated income statement
| 2022 | 2021 | 2022 | 2021 | 2021 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec |
| Net sales | 1,015 | 11,920 | 1,015 | 16,553 | 26,192 | |
| Other operating income | 113 | 4,354 | 2,284 | 6,631 | 42,481 | |
| Change in inventories of products in progress and finished goods |
-886 | -12,237 | -1,879 | -34,970 | -42,258 | |
| Raw materials and consumables | – | 69 | -1 | -242 | -1,864 | |
| Other external expenses | -14,079 | -15,998 | -43,587 | -59,940 | -79,438 | |
| Employee benefit expenses | -6,624 | -10,396 | -26,424 | -33,008 | -44,883 | |
| Depreciation, amortization and impairment | -50,857 | -7,284 | -65,378 | -21,603 | -28,877 | |
| Operating profit/loss | -71,318 | -29,572 | -133,970 | -126,579 | -128,647 | |
| Financial income | 26 | 459 | 234 | 2,453 | 2,460 | |
| Financial expenses | -390 | -1,874 | -2,917 | -5,747 | -6,534 | |
| Financial income and expenses – net | -364 | -1,415 | -2,683 | -3,294 | -4,075 | |
| Profit/loss before tax | -71,682 | -30,987 | -136,653 | -129,873 | -132,722 | |
| Income tax | – | – | – | – | – | |
| Profit/loss for the period | -71,682 | -30,987 | -136,653 | -129,873 | -132,722 | |
| Profit/loss for the period attributable to: | ||||||
| Parent Company shareholders | -71,682 | -30,987 | -136,653 | -129,873 | -132,722 | |
| Earnings per share before and after dilution, SEK |
-0.14 | -0.07 | -0.28 | -0.29 | -0.30 |
Consolidated statement of comprehensive income
| 2022 | 2021 | 2022 | 2021 | 2021 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec |
| Profit/loss for the period | -71,682 | -30,987 | -136,653 | -129,873 | -132,722 | |
| Other comprehensive income | ||||||
| Items that may subsequently be transferred to the income statement: |
||||||
| Translation differences | 71 | 9 | 360 | 743 | – | |
| Total other comprehensive income | 71 | 9 | 360 | 743 | – | |
| Comprehensive income for the period | -71,611 | -30,978 | -136,293 | -129,130 | -132,722 | |
| Comprehensive income attributable to: | ||||||
| Parent Company shareholders | -71,611 | -30,978 | -136,293 | -129,130 | -132,722 |
Consolidated statement of financial position
| TSEK | Note | Sep 30, 2022 | Sep 30, 2021 | Dec 31, 2021 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 12,998 | 18,593 | 17,108 | |
| Capitalized development costs | 2 | 342,550 | 405,683 | 400,799 |
| Other intangible assets | 37,210 | 40,404 | 39,605 | |
| Financial assets | 301 | 301 | 301 | |
| Total non-current assets | 393,059 | 464,981 | 457,813 | |
| Current assets | ||||
| Inventories | 3 | 8,027 | 16,196 | 9,897 |
| Accounts receivable | 1,322 | 5,037 | 10,101 | |
| Other current receivables | 1,762 | 44,752 | 8,680 | |
| Prepaid expenses and accrued income | 4,825 | 12,660 | 10,549 | |
| Short-term investments | 161,841 | 142,492 | 89,357 | |
| Cash and cash equivalents | 2,400 | 7,185 | 7,912 | |
| Total current assets | 180,177 | 228,322 | 136,495 | |
| TOTAL ASSETS | 573,236 | 693,303 | 594,308 | |
| EQUITY | ||||
| Equity and reserves attributable to Parent Company shareholders | ||||
| Share capital | 53,804 | 44,837 | 44,837 | |
| Other capital provided | 2,029,327 | 1,905,762 | 1,905,828 | |
| Reserves | 395 | – | 427 | |
| Retained earnings, including income for the period | -1,538,032 | -1,398,530 | -1,401,379 | |
| Equity attributable to Parent Company shareholders | 545,495 | 552,069 | 549,713 | |
| Total equity | 545,495 | 552,069 | 549,713 | |
| LIABILITIES | ||||
| Long-term liabilities | ||||
| Lease liabilities, long-term | 3,442 | 5,988 | 5,141 | |
| Total long-term liabilities | 3,442 | 5,988 | 5,141 | |
| Current liabilities | ||||
| Other borrowings | – | 80,000 | – | |
| Accounts payable | 6,547 | 6,186 | 13,590 | |
| Lease liabilities, short-term | 2,802 | 6,129 | 5,287 | |
| Other current liabilities | 2,517 | 4,942 | 3,307 | |
| Accrued expenses and deferred income | 12,434 | 37,989 | 17,270 | |
| Total current liabilities | 24,299 | 135,246 | 39,454 | |
| Total liabilities | 27,741 | 141,234 | 44,595 | |
| TOTAL EQUITY AND LIABILITIES | 573,236 | 693,303 | 594,308 |
Consolidated statement of changes in equity
| Attributable to Parent Company shareholders | ||||||||
|---|---|---|---|---|---|---|---|---|
| TSEK | Share capital |
Other capital provided |
Reserves | Retained earnings, including profit/loss for the period |
Total equity attributable to Parent Company shareholders |
Total equity |
||
| Opening balance, January 1, 2021 | 44,837 | 1,904,760 | -743 | -1,268,657 | 680,197 | 680,197 | ||
| Profit/loss for the period | – | – | – | -129,873 | -129,873 | -129,873 | ||
| Other comprehensive income | – | – | 743 | – | 743 | 743 | ||
| Comprehensive income for the period | – | – | 743 | -129,873 | -129,130 | -129,130 | ||
| Employee stock options | 1,002 | 1,002 | 1,002 | |||||
| Closing balance, September 30, 2021 | 44,837 | 1,905,761 | – | -1,398,530 | 552,069 | 552,069 | ||
| Opening balance, January 1, 2021 | 44,837 | 1,904,760 | -743 | -1,268,657 | 680,197 | 680,197 | ||
| Profit/loss for the period | – | – | – | -132,722 | -132,722 | -132,722 | ||
| Other comprehensive income | – | – | 1,170 | – | 1,170 | 1,170 | ||
| Comprehensive income for the period | – | – | 1,170 | -132,722 | -131,552 | -131,552 | ||
| Employee stock options | 1,068 | 1,068 | 1,068 | |||||
| Closing balance, December 31, 2021 | 44,837 | 1,905,828 | 427 | -1,401,379 | 549,713 | 549,713 | ||
| Opening balance, January 1, 2022 | 44,837 | 1,905,828 | 427 | -1,401,379 | 549,713 | 549,713 | ||
| Profit/loss for the period | – | – | – | -136,653 | -136,653 | -136,653 | ||
| Other comprehensive income | – | -32 | - | -32 | -32 | |||
| Comprehensive income for the period | - | - | -32 | -136,653 | -136,685 | -136,685 | ||
| Employee stock options | – | -1,792 | – | – | -1,792 | -1,792 | ||
| Share issues | 8,968 | 141,685 | 150,652 | 150,652 | ||||
| Issue expenses | – | -16,394 | – | – | -16,394 | -16,394 | ||
| Closing balance, September 30, 2022 | 53,804 | 2,029,327 | 395 | -1,538,032 | 545,494 | 545,494 |
Consolidated statement of cash flows
| 2022 | 2021 | 2022 | 2021 | 2021 | |
|---|---|---|---|---|---|
| TSEK | Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec |
| Operating activities | |||||
| Operating profit/loss | -71,318 | -29,572 | -133,970 | -126,579 | -128,647 |
| Adjustments for non-cash items | 50,857 | 3,836 | 65,378 | 17,057 | 28,877 |
| Interest paid | 863 | 232 | -1,130 | -38 | -552 |
| Cash flow from operating activities before changes in working capital |
-21,324 | -25,504 | -69,722 | -109,560 | -100,322 |
| Changes in working capital | |||||
| Change in inventories | 887 | 11,752 | 1,870 | 35,300 | 41,599 |
| Change in accounts receivable | -340 | -3,095 | 8,779 | -3,548 | -8,612 |
| Change in other current receivables | 2,548 | 25,469 | 12,642 | 18,279 | 57,462 |
| Change in accounts payable | -1,518 | -3,340 | -7,043 | -4,530 | 2,874 |
| Change in other current liabilities | -2,844 | -30,610 | -5,627 | -36,370 | -138,566 |
| Cash flow from operating activities | -22,591 | -25,328 | -59,101 | -100,429 | -145,565 |
| Investing activities | |||||
| Investments in intangible assets | – | – | – | -33,236 | -33,236 |
| Investments in property, plant and equipment | -248 | -10 | -277 | -873 | -1,113 |
| Short-term investments | – | – | -120,000 | – | – |
| Divestment of short-term investments | 25,000 | 30,000 | 45,000 | 105,000 | 153,000 |
| Cash flow from investing activities | 24,752 | 29,990 | -75,277 | 70,891 | 118,651 |
| Financing activities | |||||
| Amortization of lease liability | -1,473 | -1,398 | -4,045 | -4,382 | -5,809 |
| New share issues | – | – | 150,652 | – | – |
| Issue expenses | – | – | -16,394 | – | – |
| Cash flow from financing activities | -1,473 | -1,398 | 130,213 | -4,382 | -5,809 |
| Cash flow for the period | 688 | 3,264 | -4,165 | -33,920 | -32,723 |
| Effects of exchange rate changes on cash and | 1 | 28 | -1,347 | 977 | 507 |
| cash equivalents Cash and cash equivalents at the beginning of the period |
1,711 | 3,893 | 7,912 | 40,128 | 40,128 |
| Cash and cash equivalents at the end of the period |
2,400 | 7,185 | 2,400 | 7,185 | 7,912 |
Parent Company income statement
| 2022 | 2021 | 2022 | 2021 | 2021 | ||
|---|---|---|---|---|---|---|
| TSEK | Note | Jul–Sep | Jul–Sep | Jan–Sep | Jan–Sep | Jan–Dec |
| Net sales | 1,015 | 11,920 | 1,015 | 16,553 | 26,192 | |
| Change in inventories of products in progress and finished goods |
-886 | -12,237 | -1,879 | -34,970 | -42,258 | |
| Other operating income | 113 | -197 | 2,284 | 2,080 | 37,930 | |
| Raw materials and consumables | – | 69 | -1 | -242 | -1,864 | |
| Other external expenses | -15,116 | -17,336 | -46,700 | -63,287 | -83,770 | |
| Employee benefit expenses | -6,627 | -10,396 | -26,424 | -33,008 | -44,826 | |
| Depreciation, amortization and impairment of PPE and intangible assets |
-49,911 | -6,322 | -62,538 | -18,481 | -24,800 | |
| Operating profit/loss | -71,413 | -34,499 | -134,243 | -131,355 | -133,396 | |
| Profit/loss from participations in Group companies |
– | 330 | – | – | – | |
| Other interest income and similar income | 25 | 459 | 234 | 2,453 | 2,460 | |
| Interest expenses and similar expenses | -295 | -1,729 | -2,592 | -5,372 | -6,027 | |
| Financial income and expenses – net | -270 | -940 | -2,359 | -2,919 | -3,567 | |
| Profit/loss before tax | -71,683 | -35,439 | -136,602 | -134,274 | -136,963 | |
| Income tax on profit/loss for the period | – | – | – | – | – | |
| Profit/loss for the period | -71,683 | -35,439 | -136,602 | -134,274 | -136,963 |
Parent Company balance sheet
| TSEK | Note | Sep 30, 2022 | Sep 30, 2021 | Dec 31, 2021 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Intangible non-current assets | ||||
| Capitalized development costs Concessions, patents, licenses, trademarks and similar rights |
2 | 342,550 37,210 |
405,682 40,404 |
400,799 39,605 |
| Property, plant and equipment | ||||
| Equipment, tools and fixtures and fittings | 6,283 | 8,419 | 7,890 | |
| Construction in progress and advance payments for property, plant and equipment |
648 | 648 | 648 | |
| Financial assets | ||||
| Other securities held as non-current assets | 301 | 301 | 301 | |
| Total non-current assets | 386,991 | 455,454 | 449,243 | |
| Current assets | ||||
| Inventories, etc. | 3 | |||
| Raw materials and consumables | 5,944 | 6,971 | 7,848 | |
| Products in progress | 2,083 | 8,678 | 2,049 | |
| Finished goods | – | 547 | – | |
| 8,027 | 16,196 | 9,897 | ||
| Current receivables | ||||
| Accounts receivable | 1,322 | 5,037 | 10,101 | |
| Other current receivables | 1,762 | 44,751 | 8,680 | |
| Prepaid expenses and accrued income | 5,677 | 13,027 | 10,920 | |
| 8,761 | 62,815 | 29,701 | ||
| Short-term investments | 161,841 | 142,492 | 89,357 | |
| Cash and bank balances | 2,400 | 7,185 | 7,898 | |
| Total current assets | 181,029 | 228,688 | 136,853 | |
| TOTAL ASSETS | 568,021 | 684,142 | 586,096 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Restricted equity | ||||
| Share capital | 53,804 | 44,837 | 44,837 | |
| Statutory reserve | 4,620 | 4,620 | 4,620 | |
| Reserve for development costs | 20,927 | 25,819 | 25,394 | |
| 79,351 | 75,276 | 74,851 | ||
| Non-restricted equity | ||||
| Share premium reserve | 2,029,640 | 1,905,762 | 1,906,141 | |
| Retained earnings | -1,426,231 | -1,294,160 | -1,293,735 | |
| Profit/loss for the period | -136,602 | -134,274 | -136,964 | |
| 466,807 | 477,328 | 475,442 | ||
| Total equity1 | 546,159 | 552,604 | 550,293 | |
| Current liabilities | ||||
| Other borrowings Accounts payable |
– 6,547 |
80,000 6,185 |
– 13,590 |
|
| Liabilities to Group companies | – | – | – | |
| Other current liabilities | 2,517 | 4,941 | 3,307 | |
| Accrued expenses and deferred income | ||||
| 12,799 | 40,412 | 18,906 | ||
| Total current liabilities | 21,862 | 131,538 | 35,803 | |
| TOTAL EQUITY AND LIABILITIES | 568,021 | 684,142 | 586,096 |
Parent Company statement of changes in equity
| Restricted equity | Non-restricted equity | |||||
|---|---|---|---|---|---|---|
| TSEK | Share capital |
Statutory reserve |
Reserve for development costs |
Share premium reserve |
Retained earnings, including profit/loss for the year |
Total equity |
| Opening balance, January 1, 2021 | 44,837 | 4,620 | 27,096 | 1,905,073 | -1,296,837 | 684,789 |
| Profit/loss for the period | – | – | – | – | -134,274 | -134,274 |
| Reversal of Reserve for development costs |
– | – | -1,277 | – | 1,277 | – |
| Results from fusion | – | 1,400 | 1,400 | |||
| Employee stock options | – | – | – | 689 | – | 689 |
| Closing balance, September 30, 2021 | 44,837 | 4,620 | 25,819 | 1,905,762 | -1,428,434 | 552,604 |
| Opening balance, January 1, 2021 | 44,837 | 4,620 | 27,096 | 1,905,073 | -1,296,837 | 684,789 |
| Profit/loss for the year | – | – | – | – | -136,963 | -136,963 |
| Reversal of Reserve for development costs |
– | – | -1,702 | – | 1,702 | – |
| Results from fusion | – | – | – | – | 1,400 | 1,400 |
| Employee stock options | – | – | – | 1,068 | – | 1,068 |
| Closing balance, December 31, 2021 | 44,837 | 4,620 | 25,394 | 1,906,141 | -1,430,699 | 550,293 |
| Opening balance, January 1, 2022 | 44,837 | 4,620 | 25,394 | 1,906,141 | -1,430,699 | 550,293 |
| Profit/loss for the period | – | – | – | – | -136,602 | -136,602 |
| Reversal of Reserve for development costs |
– | – | -4,467 | – | 4,467 | – |
| Employee stock options | – | – | – | -1,792 | -1,792 | |
| Share issues | 8,968 | 141,685 | 150,652 | |||
| Issue expenses | – | – | – | -16,394 | – | -16,394 |
| Closing balance, September 30, 2022 | 53,804 | 4,620 | 20,927 | 2,029,640 | -1,562,833 | 546,159 |
Note 1 Accounting policies, etc.
This condensed interim report for the Group has been prepared in accordance with IAS 34 Interim Financial Reporting and applicable regulations in the Annual Accounts Act.
The interim report for the Parent Company has been prepared in accordance with Chapter 9 of the Annual Accounts Act, Interim Report.
The Group's and the Parent Company's accounting policies and calculation methods are consistent with those used in the Annual Report for the fiscal year from January 1, 2021 to December 31, 2021.
No new or amended IFRS standards or IFRIC interpretations have entered force since January 1, 2022 that have had any impact on Vivesto's financial statements.
The carrying amounts for loan receivables, other receivables, cash and cash equivalents, accounts payable and other liabilities comprise reasonable approximations of fair value.
The Group currently has only one operating segment and does not therefore report any information by segment.
Note 2 Capitalized development costs
Vivesto has capitalized development costs consisting of the company's work on clinical trials in Phase III for the product candidates Paclical/Apealea® and Paccal Vet. The accumulated assets by product candidate are shown below.
| TSEK | Sep 30, 2022 | Sep 30, 2021 | Dec 31, 2021 |
|---|---|---|---|
| Paclical | 233,142 | 296,275 | 291,392 |
| Paclical Vet | 109,408 | 109,408 | 109,408 |
| Total | 342,550 | 405,683 | 400,800 |
Amortization in the period amounted to TSEK 20,754 (21,603). In July, Vivesto decided to wind down its activities in Russia following the Russian invasion of Ukraine, ongoing hostilities and international sanctions. Accordingly, capitalized costs of TSEK 44,624 for Paclical in Russia were written down after amortization in June.
Note 3 Inventories
| TSEK | Sep 30, 2022 | Sep 30, 2021 | Dec 31, 2021 |
|---|---|---|---|
| Measured at cost | |||
| Raw materials and consumables | 5,944 | 6,971 | 7,848 |
| Products in progress | 2,083 | 8,678 | 2,049 |
| Finished goods | 0 | 547 | 0 |
| Total | 8,027 | 16,196 | 9,897 |
Goods have been expensed and written down as follows:
| 2022 | 2021 | 2021 | |
|---|---|---|---|
| TSEK | Jan–Sep | Jan–Sep | Jan–Dec |
| Expensed goods | 886 | 17,330 | 24,263 |
| Written down goods | 993 | 17,448 | 17,995 |
Note 4 Transactions with related parties
During the period, expenses in the form of consultancy fees to members of the Board or management were recognized in an amount of TSEK 1,976 (1,680). Otherwise, no material transactions with related parties were conducted during the period other than the remuneration disbursed to Board members and employees.
Note 5 Contingent liabilities, pledged assets and contingent assets
The Parent Company has taken out a chattel mortgage of TSEK 8,000 with a bank as collateral for an overdraft facility of TSEK 5,000 (and as the limit for a foreign currency derivative of TSEK 3,000.
Note 6 Risk factors
The Group is exposed to various types of risk through its operations. Through creating awareness of the risks inherent to operations, these risks can be limited, controlled and managed at the same time as business opportunities can be leveraged to increase earnings. The risks pertaining to the Company's operations are detailed in the Annual Report for the fiscal year from January 1, 2021 to December 31, 2021.
The Board of Directors and the acting CEO of Vivesto AB certify that this Interim report gives a fair view of the Parent Company's and the Group's activities, position and results, and describes essential risks and uncertainty factors that the Parent Company and the companies that are part of the Group face.
Uppsala, November 17, 2022
Peter Zonabend, Chairman of the Board Hege Hellström, Member of the Board
Pål Ryfors, Member of the Board Roger Tell, Member of the Board
Christer Nordstedt, acting CEO
This report contains forward-looking statements including valuations of intangible assets which are based on assessments of future economic conditions, the impact from competing products and pricing, currency effects and other risks. These forward-looking statements reflect Vivesto management's view of future events at the time these statements are made but are events. When words such as "foresees," "believes," "estimates," "expects," "intends," "plans" and "projects" occur in this report, they represent forward-looking statements. These statements may include risks and uncertainties concerning, for example, product demand, market acceptance, effects of made subject to different risks and uncertainties. All these forward-looking statements are based on Vivesto management's estimates and assumptions and are assessed to be reasonable but are by their very nature uncertain and difficult to foresee. Actual outcomes and experiences may deviate considerably from the forward-looking statements. Vivesto does not intend, and does not undertake, to update these forward-looking statements.
This information is information that Vivesto AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out below, at 08:00 CET on November 17, 2022.
This report has been prepared in both Swedish and English. In the event of any discrepancy in the content of the two versions, the Swedish version shall take precedence.
This report has been subject to review by the company's auditors.
Translation from the Swedish original
Review report
Vivesto AB (publ) Corp. id. 556332-6676
Introduction
We have reviewed the condensed interim financial information (interim report) of Vivesto AB (publ) as of 30 September 2022 and the nine-month period then ended. The Board of Directors and the Managing Director are responsible for the preparation and presentation of this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.
Scope of review
We conducted our review in accordance with International Standard on Review Engagements ISRE 2410 Review of Interim Financial Information Performed by the Independent Auditor of the Entity. A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on Auditing and other generally accepted auditing practices and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the interim report is not prepared, in all material respects, for the Group in accordance with IAS 34 and the Annual Accounts Act, and for the Parent Company in accordance with the Annual Accounts Act.
Stockholm 17 November 2022
KPMG AB
Duane Swanson Henrik Lind Auditor in charge
Authorized Public Accountant Authorized Public Accountant
COMPANY INFORMATION
Vivesto Pharmaceutical AB (publ) Corp. reg. no. 556332-6676 Domicile: Stockholm
Contact
Vivesto Pharmaceutical AB Vallongatan 1 752 28 Uppsala, Sweden
Head Office: Vivesto Pharmaceutical AB Gustav III:s Boulevard 46, 5th floor 169 73 Solna, Sweden
Phone: +46 18-50 54 40 Website: www.vivesto.com E-mail: [email protected]
For more information
Christer Nordstedt, acting Chief Executive Officer Phone: +46 18-50 54 40 E-mail: [email protected]
Robert Maiorana, acting Chief Financial Officer Phone: +46 18-50 54 40 E-mail: [email protected]
Financial calendar
Year-end report (Jan-Dec 2022) February 23, 2023 Annual Report publication Week 17, 2023 Interim report Q1 (Jan-Mar 2023) May 25, 2023 Annual General Meeting 2023 May 25, 2023 Interim report Q2 (Jan-Jun 2023) August 24, 2023 Interim report Q3 (Jan-Sep 2023) November 16, 2023 Year-end report (Jan-Dec 2023) February 23, 2024