Quarterly Report • Nov 15, 2022
Quarterly Report
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"The recent initiation of two clinical trials and bolstering of our cash position has been transformational for the Company as we continue to execute on our strategy.
Mounting evidence substantiates that AXL plays a significant role in exacerbating many severe cancers and respiratory diseases.
We believe that AXL inhibition by our lead compound, bemcentinib, can make a lifechanging difference in patients suffering from STK11m NSCLC and hospitalized COVID -19."
Martin Olin Chief Executive Officer
Ø Randomized first patient in the Phase 2b EU-SolidAct platform for hospitalized COVID-19 patients
Ø Initiated Phase 1b/2a trial in 1st line NSCLC patients harboring STK11 mutations
Ø In a difficult financial environment BerGenBio strengthened its financial position by securing a NOK 100 million loan facility from its largest shareholder. In addition to the cash position of NOK 225 million end of September 2022 the loan facility enables the Company to continue pursuing its focused strategy.
| (NOK million) | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | FY 2021 |
|---|---|---|---|---|---|
| Operating revenues | 0,0 | 0,0 | 0,0 | 0,0 | 0,8 |
| Operating expenses | 62,4 | 71,4 | 229,2 | 247,1 | 315,2 |
| Operating profit (-loss) | -62,4 | -71,4 | -229,2 | -247,1 | -314,5 |
| Profit (-loss) after tax | -59,8 | -70,5 | -224,9 | -240,6 | -309,4 |
| Basic and diluted earnings (loss) per | |||||
| share (NOK) | -0.67 | -0.80 | -2.54 | -2.74 | -3.52 |
| Net cash flow in the period | -65,0 | -61.7 | -206,5 | -208,2 | -284,2 |
| Cash position end of period | 225,1 | 509,4 | 225,1 | 509,4 | 436,6 |
BerGenBio's lead compound, bemcentinib, is a potentially first-in-class highly selective inhibitor of the receptor tyrosine kinase AXL, which is activated in response to oxidative stress, inflammation, hypoxia and drug treatment, resulting in a number of deleterious effects in cancer and severe respiratory diseases. Bemcentinib inhibits AXL activation to prevent the progression of serious disease through the modulation of resistance mechanisms and the adaptive immune system.
BerGenBio is advancing bemcentinib in two lung indications, STK11 mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19 patients, where bemcentinib's novel mechanisms of action and primary accumulation in the lungs make it uniquely positioned to address significant unmet medical needs.
Subsequent to the quarter end, BerGenBio announced in October the initiation of a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care in 1st line NSCLC, the checkpoint inhibitor pembrolizumab and platinum doublet chemotherapy, for the treatment of 1st line NSCLC patients harboring STK11 mutations.
Approximately 20% of non-squamous NSCLC patients harbor STK11 mutations, which are a recognized resistance mechanism for anti-PD-1/L1 therapy and currently result in a poor prognosis with standard of care treatment in 1st line NSCLC. The Company believes that STK11m patients almost universally express AXL, causing a severely immunosuppressed tumor microenvironment, the development of drug resistance, immune evasion and metastasis. Preclinical and clinical data suggest that bemcentinib's inhibition of AXL on immune and cancer cells sensitizes STK11m NSCLC patients to checkpoint inhibitors and improves the effects of chemotherapy.
The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care in 1st line untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no other actionable comutations. The first patient is expected to begin treatment in the fourth quarter of 2022.
BerGenBio announced in September that the first patient was randomized in a Phase 2b trial evaluating bemcentinib in hospitalized COVID-19 patients. The trial is part of the EU-SolidAct platform, a pan-European research project designed to investigate treatment options for hospitalized patients with COVID-19 and emerging infectious diseases.
Higher levels of AXL expression and activation caused by COVID-19 infection have been linked to an increase in disease severity. The interaction of AXL and SARS-CoV-2 is believed to promote the entry and enhancement of infection in pulmonary and bronchial epithelial cells. Through the inhibition of AXL, bemcentinib blocks viral entry, stimulates the innate immune system and promotes lung tissue repair.
The Phase 2b, multi-center, randomized, placebo-controlled trial will enroll up to 500 patients, includes 68 clinical sites in 8 countries and is sponsored by Oslo University Hospital, Norway, in collaboration with the Institut National de la Santé Et de la Recherche Médicale (Inserm), France, and the not-for-profit intergovernmental organization European Clinical Research Infrastructure Network (ECRIN).
In study BGBC003 of Relapsed/Recurrent AML patients, the last patient completed their last visit in late Q2, with database lock completed in Q3. In study BGBC008 of 2L NSCLC patients, the last patient's last visit occurred in Q4 2022. The Company expects to provide results of these studies following database lock and subsequent data analysis in H1 of 2023.
Following the end of the third quarter, BerGenBio announced in October that it secured up to NOK 100 million as a shareholder loan facility from Meteva AS, a 27.23% shareholder in BerGenBio. In addition to the Company's existing cash position, the facility will enable BerGenBio to continue advancing its lead compound, bemcentinib, in 1L STK11m NSCLC and hospitalized COVID-19 patients.
The Group operates in a highly competitive industry sector with many large players and may be subject to rapid and substantial technological change.
BerGenBio is currently in a development phase involving activities that entail exposure to various risks. BerGenBio's lead product candidate bemcentinib is currently in Phase II clinical trials. This is regarded as an early stage of development and the clinical studies may not prove to be successful. Timelines for completion of clinical studies are to some extent dependent on external factors outside the control of the Group, including resource capacity at clinical trial sites, competition for patients, etc.
The financial success of BerGenBio and / or its commercial partners requires obtaining marketing authorisation and securing an acceptable reimbursement price for its drugs. There can be no guarantee that the drugs will obtain the selling prices or reimbursement rates foreseen.
BerGenBio and / or its commercial partners will need approvals from the US Food & Drug Administration (FDA) to market its products in the US, and from the European Medicines Agency (EMA) to market its products in Europe, as well as equivalent regulatory authorities in other worldwide jurisdictions to commercialise in those regions. The future earnings are likely to be largely dependent on the timely marketing authorisation of bemcentinib for various indications.
The Group holds cash and cash equivalents and does not have any borrowings. The Group's interest rate risk is therefore in the rate of return of its cash on hand. Bank deposits are exposed to market fluctuations in interest rates, which affect the financial income and the return on cash.
The value of non-Norwegian currency denominated costs will be affected by changes in currency exchange rates or exchange control regulations. The Group undertakes various transactions in foreign currencies and is consequently exposed to fluctuations in exchange rates. The exposure arises largely from the clinical trials and research expenses. The Group is mainly exposed to fluctuations in euro (EUR), pounds sterling (GBP) and US dollar (USD). The Group are holding part of the bank deposit in EUR, GBP and USD depending on the need for such foreign exchange.
The foreign currency exposure is also mostly linked to trade payables with short payment terms. The Group might consider changing its current risk management of foreign exchange rate if it deems it appropriate.
Credit risk is the risk of counterparty's default in a financial asset, liability or customer contract, giving a financial loss. The Group's receivables are generally limited to receivables from public authorities by way of government grants. The credit risk generated from financial assets in the Group is limited since it is cash deposits. The Group places its cash in bank deposits in recognised financial institutions to limit its credit risk exposure.
The Group has not suffered any loss on receivables during 2022 and the Group considers its credit risk as low.
Liquidity is monitored on a continuing basis by Group management.
The Group works continuously to ensure financial flexibility in the short and long term to achieve its strategic and operational objectives.
Funding of ongoing operations is and will be for some time depending on external sources, mainly equity contributions. Significant changes to financial market conditions, may affect the climate for investor investments.
In October 2022 the Company secured a shareholder loan facility of up to NOK 100 million and the Groups liquidity situation is considered to be satisfactory.
The Group's lead product candidate, bemcentinib, is currently in Phase II clinical trials and the Group's clinical studies may not prove to be successful.
The Group operates in a highly competitive industry sector with many large players and is subject to rapid and substantial technological change.
The success of the company will highly depend on the company's ability to obtain and maintain patent protection for its products, methods, processes and other technologies, to prevent third parties from infringing proprietary rights of the company and to operate without infringing the proprietary rights of third parties. To date, the company holds certain exclusive patent rights in major markets. The patent rights are limited in time. The company cannot predict the range of protection any patents will afford against competitors and competing technologies, including whether third parties will find ways to invalidate the patents, obtain patents claiming aspects similar to those covered by the company's patents and patents applications, and whether the company may be subject to litigation proceedings.
The financial success of the Group requires obtaining marketing authorisation and achieving an acceptable reimbursement price for its drugs. There can be no guarantee that the Group's drugs will obtain the selling prices or reimbursement rates foreseen by the Group. The Group will need approvals from the US Food and Drug Administration (FDA) to market its products in the US, and from the European Medicines Agency (EMA) to market its products in Europe, as well as equivalent regulatory authorities in other worldwide jurisdictions to commercialise in those regions. The Group's future earnings are likely to be largely dependent on the timely marketing authorisation of bemcentinib for various indications.
The long-term impact of the COVID-19 crisis remains unclear although no greater for BerGenBio than any other business in the sector. Our ability to conduct clinical trials at the expected pace is a risk factor in the evolving pandemic.
(Figures in brackets = same period 2021 unless stated otherwise)
Revenue for the third quarter 2022 amounted to NOK 0.0 million (NOK 0.0 million) and year to date (YTD) 2022 NOK 0.0 million (NOK 0 million).
Total operating expenses for the third quarter 2022 amounted to NOK 62.4 million (NOK 71.4 million) and YTD 2022 NOK 229.2 million (NOK 247.1 million).
Payroll and other employee related cost in the third quarter were NOK 13.6 million (NOK 26.7 million) and YTD 2022 NOK 49.8 million (NOK 57.3 million). The decrease in the quarter and YTD year on year is related to severance payment to departing CEO in Q3 2021 and the effect of decreased headcount due to rightsizing of the organization in connection with the company's focused strategy announced in May 2022.
Employee share option costs in the third quarter were NOK 0.5 million (NOK -0.6 million) and YTD 2022 NOK 1.3 million (NOK 1.9 million). The decrease YTD year on year is a non-cash effect of decrease in accruals for national insurance cost driven by a decrease in the share price.
Other operating expenses amounted to NOK 48.2 million (NOK 45.0 million) for the third quarter and NOK 177.3 million (NOK 187.0 million) YTD. Operating expenses are mainly driven by activities in the development programs.
The operating loss for the third quarter amounts to NOK 62.4 million (NOK 71.4 million) and YTD 2022 NOK 229.2 million (NOK 247.1 million), reflecting the level of activity related to the development programs BerGenBio is conducting.
Net financial items amounted to a profit of NOK 2.6 million (profit of NOK 0.9 million) for the third quarter related to net gain on foreign exchanges and interest on cash deposit. YTD 2022 the net financial items amounted to a profit of NOK 4.3 million (profit of NOK 6.5 million).
Losses after tax for the third quarter were NOK 59.8 million (NOK 70.5 million) and YTD 2022 NOK 224.9 million (NOK 240.6 million).
Total assets as of 30 September 2022 decreased to NOK 235.5 million (NOK 306.0 million as of 30 June 2022) mainly due to the operational loss in the period.
Total liabilities were NOK 70.6 million as of 30 September 2022 (NOK 82.0 million as of 30 June 2022).
Total equity as of 30 September 2022 was NOK 164.9 million (NOK 224.0 million as of 30 June 2022), corresponding to an equity ratio of 70.0% (73.2% as of 30 June 2022).
Net cash flow to operating activities was NOK 65.8 million in the third quarter (NOK 67.2 million) and NOK 210.7 million YTD 2022 (NOK 223.8 million), mainly driven by the level of activity in the development programs.
Net cash flow from investing during the third quarter was NOK 0.8 million (NOK 0.4 million) and YTD 2022 NOK 1.3 million (NOK 0.6 million).
Net cash flow from financing activities in the third quarter 2022 was NOK 0 million (NOK 5.0 million) and YTD 2022 NOK 2.9 million (NOK 15.0 million).
Cash and cash equivalents decreased to NOK 225.0 million by 30 September 2022 (NOK 292.1 by 30 June 2022 and NOK 509.4 by 30 September 2021).
The Board's aim is to continue its work towards a number of upcoming milestones, to be achieved across the Company's oncology and infectious diseases pipeline.
The Company has reiterated its focus on the clinical development of bemcentinib within NSCLC STK11m and respiratory diseases (initially COVID-19). Each of the therapeutic areas represents in the opinion of the Board attractive commercial opportunities.
With the announcement of the shareholder loan facility of up to NOK 100 million in October 2022 the Company has secured liquidity to progress its activities and with a strong team in place to continue the advancement of its pipeline and working towards delivering new treatment options for patients in need and value for shareholders.
The Board today considered and approved the condensed, consolidated financial statement of the nine months ending 30 September 2022 for BerGenBio.
Anders Tullgren, Chairman Sally Bennett
Sveinung Hole François Thomas
Debra Barker Martin Olin, CEO
| (NOK 1000) Unaudited | Note | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | FY 2021 |
|---|---|---|---|---|---|---|
| Revenue | 0 | 0 | 0 | 0 | 774 | |
| Expenses | ||||||
| Payroll and other related employee cost |
3, 10 | 13,621 | 26,669 | 49,847 | 57,297 | 69,929 |
| Employee share option cost | 3 | 481 | -562 | 1,272 | 1,851 | 4,116 |
| Depreciation | 2 | 140 | 335 | 771 | 1,005 | 1,312 |
| Other operating expenses | 6 | 48,186 | 44,977 | 177,342 | 186,990 | 239,880 |
| Total operating expenses | 62,428 | 71,419 | 229,231 | 247,143 | 315,237 | |
| Operating profit (-loss) | -62,428 | -71,419 | -229,231 | -247,143 | -314,464 | |
| Finance income | 6,420 | 3,028 | 12,793 | 11,966 | 15,993 | |
| Finance expense | 3,789 | 2,107 | 8,495 | 5,420 | 10,894 | |
| Financial items, net | 2,631 | 920 | 4,298 | 6,545 | 5,100 | |
| Profit (-loss) before tax | -59,797 | -70,498 | -224,933 | -240,598 | -309,364 | |
| Income tax expense | 0 | 0 | 0 | 0 | 0 | |
| Profit (-loss) after tax | -59,797 | -70,498 | -224,933 | -240,598 | -309,364 | |
| Other comprehensive income | ||||||
| Items that may be reclassified to profit and loss in subsequent periods |
||||||
| Translation effects | 276 | 0 | 231 | 0 | -112 | |
| Total comprehensive income (-loss) for the period |
-59,520 | -70,498 | -224,702 | -240,598 | -309,476 | |
| Earnings per share: | ||||||
| - Basic and diluted per share | 7 | -0.67 | -0.80 | -2.54 | -2.74 | -3.52 |
| (NOK 1000) Unaudited | Note | 30 SEP 2022 | 30 SEP 2021 | 31 DEC 2021 |
|---|---|---|---|---|
| ASSETS | ||||
| Non-current assets | ||||
| Property, plant and equipment | 156 | 1,498 | 1,191 | |
| Total non-current assets | 156 | 1,498 | 1,191 | |
| Other current assets | 5, 8 | 10,289 | 4,086 | 12,398 |
| Cash and cash equivalents | 225,072 | 509,408 | 436,646 | |
| Total current assets | 235,361 | 513,494 | 449,045 | |
| TOTAL ASSETS | 235,517 | 514,992 | 450,236 | |
| EQUITY AND LIABILITIES | ||||
| Equity | ||||
| Paid in capital | ||||
| Share capital | 9 | 8,866 | 8,825 | 8,846 |
| Share premium | 9 | 113,684 | 400,875 | 335,195 |
| Other paid in capital | 4, 9 | 42,349 | 38,219 | 40,386 |
| Paid in, not registered capital | 9 | 0 | 2,201 | 2,201 |
| Total paid in capital | 164,899 | 450,120 | 384,426 | |
| Total equity | 164,899 | 450,120 | 384,426 | |
| Non-current liabilities | ||||
| Long term debt | 0 | 1,016 | 942 | |
| Total non-current liabilities | 0 | 1,016 | 942 | |
| Current liabilities | ||||
| Accounts payable | 32,218 | 22,283 | 26,726 | |
| Other current liabilities | 38,400 | 40,572 | 37,172 | |
| Provisions | 0 | 1,002 | 969 | |
| Total current liabilities | 70,618 | 63,857 | 64,868 | |
| Total liabilities | 70,618 | 64,872 | 65,810 | |
| TOTAL EQUITY AND LIABILITIES |
235,517 | 514,992 | 450,236 |
| (NOK 1000) Unaudited | Note | Share capital |
Share premium |
Other paid in capital |
Paid in, not registered |
Total equity |
|---|---|---|---|---|---|---|
| Balance as of 1 January 2022 | 8,846 | 335,195 | 40,386 | 0 | 384,426 | |
| Loss for the period | -224,933 | -224,933 | ||||
| Other comprehensive income (loss) for the period, net of income tax |
231 | 231 | ||||
| Total comprehensive income for the period |
0 | -224,702 | 0 | 0 | -224,702 | |
| Recognition of share-based payments | 3, 4 | 1,964 | 1,964 | |||
| Issue of ordinary shares | 9 | 21 | 3,198 | 3,218 | ||
| Share issue costs | 9 | -7 | -7 | |||
| Transactions with owners | 21 | 3,191 | 1,964 | 0 | 5,175 | |
| Balance as of 30 September 2022 | 8,866 | 113,684 | 42,349 | 0 | 164,899 |
| (NOK 1000) Unaudited | NoteShare | capital | Share premium |
Other paid in capital |
Paid in, not registered |
Total equity |
|---|---|---|---|---|---|---|
| Balance as of 1 January 2021 | 8,726 | 628,231 | 33,272 | 0 | 670,229 | |
| Loss for the period | -240,598 | -240,598 | ||||
| Other comprehensive income (loss) for the period, net of income tax |
0 | 0 | ||||
| Total comprehensive income for the period |
0 | -240,598 | 0 | 0 | -240,598 | |
| Recognition of share-based payments | 3, 4 | 4,947 | 4,947 | |||
| Issue of ordinary shares | 9 | 99 | 13,279 | 13,378 | ||
| Share issue costs | 9 | -38 | -38 | |||
| Paid in, not registered capital | 2,201 | 2,201 | ||||
| Transactions with owners | 99 | 13,241 | 4,947 | 2,201 | 20,489 | |
| Balance as of 30 September 2021 | 8,825 | 400,875 | 38,219 | 2,201 | 450,120 |
| (NOK 1000) Unaudited | Note | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | FY 2021 |
|---|---|---|---|---|---|---|
| Cash flow from operating activities | ||||||
| Loss before tax | -59,520 | -70,498 | -224,702 | -240,598 | -309,476 | |
| Adjustments for: | ||||||
| Depreciation of property, plant and equipment |
140 | 335 | 771 | 1,005 | 1,312 | |
| Share-based payment expense | 3, 4 | 421 | 433 | 1,964 | 4,947 | 7,113 |
| Movement in provisions and pensions | 0 | -1,437 | -969 | -5,006 | -5,039 | |
| Currency gains not related to operating activities |
2,023 | 2,935 | 5,065 | 3,998 | 779 | |
| Net interest received | -480 | -419 | -1,009 | -558 | -3,130 | |
| Working capital adjustments: | ||||||
| Decrease in trade and other receivables and prepayments |
3,036 | 4,823 | 2,109 | 10,142 | 1,830 | |
| Increase in trade and other payables | -11,447 | -3,352 | 6,051 | 2,234 | 3,270 | |
| Net cash flow from operating activities | -65,828 | -67,179 | -210,721 | -223,835 | -303,340 | |
| Cash flows from investing activities | ||||||
| Net interest received | 480 | 419 | 1,009 | 558 | 3,130 | |
| Sale of property, plant and equipment | 299 | 0 | 299 | 0 | 0 | |
| Net cash flow from investing activities | 778 | 419 | 1,308 | 558 | 3,130 | |
| Cash flows from financing activities | ||||||
| Proceeds from issue of share capital | 9 | 0 | 5,292 | 3,218 | 15,579 | 16,629 |
| Share issue costs | 9 | 0 | 0 | -7 | -38 | -70 |
| Repayment of lease liabilities | 0 | -221 | -307 | -499 | -565 | |
| Net cash flow from financing activities | 0 | 5,071 | 2,904 | 15,043 | 15,995 | |
| Effects of exchange rate changes on cash and cash equivalents |
-2,023 | -2,935 | -5,065 | -3,998 | -779 | |
| Net increase/(decrease) in cash and cash equivalents |
-65,049 | -61,689 | -206,509 | -208,235 | -284,216 | |
| Cash and cash equivalents at beginning of period |
292,144 | 574,033 | 436,646 | 721,641 | 721,641 | |
| Cash and cash equivalents at end of period |
225,072 | 509,408 | 225,072 | 509,409 | 436,646 |
BerGenBio ASA ("the Company") and its subsidiary (together "the Group") is a clinical stage biopharmaceutical company focused on developing novel medicines for aggressive diseases, including advanced cancers and patients hospitalized with COVID-19.
BerGenBio ASA is a limited public liability company incorporated and domiciled in Norway. The address of the registered office is Jonas Lies vei 91, 5009 Bergen, Norway.
The condensed interim financial information is unaudited. These interim financial statements cover the three-months period ended 30 September 2022 and were approved for issue by the Board of Directors on 14 November 2022.
The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Group's annual financial statements for the year ended 31 December 2021.
The new and amended standards and interpretations from IFRS that were adopted by the EU with effect from 2021 did not have any significant impact on the reporting for Q3 2022.
The Group has not early adopted any standard, interpretation or amendment that has been issued but is not yet effective.
Amounts are in Norwegian kroner (NOK) unless stated otherwise. The functional currency of the group is NOK. BerGenBio Limited has changed functional currency to GBP from 1 November 2021.
The consolidated financial statements comprise the financial statements of the Company and its subsidiary as of 30 September 2022. The subsidiary is BerGenBio Limited, located in Oxford in the United Kingdom and is 100% owned and controlled by the parent company BerGenBio ASA.
Preparation of the accounts in accordance with IFRS requires the use of judgment, estimates and assumptions that have consequences for recognition in the balance sheet of assets and liabilities and recorded revenues and expenses. The use of estimates and assumptions are based on the best discretionary judgment of the Group's management. The Group works continuously to ensure financial flexibility in the short and long term to achieve its strategic and operational objectives.
Capital markets are used as a source of liquidity when this is appropriate and when conditions in these markets are acceptable. The company secured in total NOK 740 million in new equity funding during 2020. Cash position at end of Q3 2022 was NOK 225 million, and with the addition of the up to NOK 100 million shareholder loan facility announced in October 2022 the Board of Directors has reasonable expectation that the Group will maintain adequate resources to continue in operational existence for the foreseeable future. The interim financial statements are prepared under the going concern assumption.
| (NOK 1000) | ||||
|---|---|---|---|---|
| Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | |
| Salaries | 10,885 | 22,827 | 41,586 | 48,540 |
| Social security tax | 2,087 | 3,263 | 5,494 | 6,429 |
| Pension expenses | 899 | 1,210 | 3,206 | 3,272 |
| Short term incentive | 0 | 0 | 0 | 0 |
| Other remuneration and employee expenses | 93 | 239 | 588 | 684 |
| Government grants 1) | -342 | -870 | -1,027 | -1,628 |
| Total payroll and other employee related cost | 13,621 | 26,669 | 49,847 | 57,297 |
| Share option expense employees | 421 | 433 | 1,964 | 4,947 |
| Change in accrued social security tax on share options |
59 | -996 | -692 | -3,096 |
| Total employee share option cost | 481 | -562 | 1,272 | 1,851 |
| Total employee benefit cost | 14,102 | 26,107 | 51,119 | 59,148 |
| Average number of full time equivalent employees | 34 | 45 |
1) See also note 5 for government grants
The Group has a Long-Term Incentive Program for employees, a share option program. Each option gives the right to acquire one share in BerGenBio at exercise.
The program ensures focus and aligns the Group's long-term performance with shareholder values and interest. Most of the employees in the Group take part in the option program. The program also serves to attract and retain senior management.
The exercise price for options granted is set at the market price of the shares at the time of grant of the options. In general, for options granted after 2012 the options expire eight years after the date of grant.
Primarily the options vest annually in equal tranches over a three-year period following the date of grant.
0 options were granted in the nine months period ended 30 September 2022 and 1.379.871 options were granted in the nine months period ended 30 September 2021.
Balance as of 30 September 2,396,473 22.21 3,703,766 22.76
| Vested options | First nine months | |
|---|---|---|
| 2022 | 2021 | |
| Options vested as of 1 January | 1,541,168 | 1,887,201 |
| Exercised and forfeited in the period | -713,088 | -1,153,195 |
| Vested in the period | 832,844 | 847,160 |
| Options vested as of 30 September | 1,660,924 | 1,581,166 |
| Total outstanding number of options | 2,396,473 | 3,703,766 |
The options are valued using the Black-Scholes model.
The risk free interest rates are based on rates from Norges Bank and Oslo Børs on the Grant Date (bonds and certificates) equal to the expected term of the option being valued. Where there is no exact match between the term of the interest rates and the term of the options, interpolation is used to estimate a comparable term.
The vesting period is the period during which the conditions to obtain the right to exercise must be satisfied. The Group has estimated an expected vesting date and this date is used as basis for the expected lifetime. The Group expects the options to be exercised earlier than the expiry date.
For valuation purposes 66,54 % expected future volatility has been applied.
For the nine months period ending 30 September the value of the share options expensed through the profit or loss amounts to NOK 2.0 million (for the same period in 2021: NOK 4.9 million). In addition, a change in provision for social security contributions on share options of NOK -0.7 million (for the same period in 2021: NOK - 3.1 million). The provision for social security contribution is calculated on the difference between the share price and exercise price on exercisable option as at the end of the period.
| Option holder | Position | Number of options outstanding 30 Sep 2022 |
Weighted Average Strike Price 2022 |
Number of options outstanding 30 Sep 2021 |
Weighted Average Strike Price 2021 |
|---|---|---|---|---|---|
| Rune Skeie | Chief Financial Officer | 297,097 | 22,71 | 297,097 | 22,71 |
| James Barnes | Chief Operating Officer | 301,522 | 19,85 | 301,522 | 19,85 |
| 598,619 | 598,619 |
Government grants have been recognised in the profit and loss as a reduction of related expense with the following amounts:
| (NOK 1000) | ||||
|---|---|---|---|---|
| Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | |
| Employee benefit expenses | 342 | 870 | 1,027 | 1,628 |
| Other operating expenses | 1,242 | 578 | 4,069 | 1,730 |
| Total | 1,584 | 1,447 | 5,096 | 3,358 |
Grants receivable as of 30 September are detailed as follows:
| 30 Sep 2022 |
30 Sep 2021 |
|
|---|---|---|
| Grants from Research Council, BIA | 172 | 189 |
| Grants from Research Council, PhD | 132 | 130 |
| Grants from SkatteFunn | 3,562 | 0 |
| Grants R&D UK | 4,323 | 2,640 |
| Total grants receivable | 8,189 | 2,959 |
Company currently has one grant from the Research Council, program for user-managed innovation arena (BIA) in 2022.
The BIA grant ("AXL as a therapeutic target in fibrosis; biology and biomarkers") has been awarded from 2019 and amount up to NOK 10.7 million. The Group has recognized NOK 0.3 million in Q3 2022 (Q3 2021: NOK 1.7 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses
BerGenBio was awarded two grants supporting industrial PhD's in 2020. The fellowship covers 50 % of the established current rates for doctoral research fellowships and an operating grant to cover up to 50 % of additional costs related to costly laboratory testing connected with the research fellow's doctoral work.
The Group has recognized NOK 1.2 million in Q3 2022 (Q3 2021 : NOK 1.2 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
BerGenBio has been awarded a NOK 24 million (USD 2.85 million) grant from Innovation Norway to support the clinical development of BGB324 in combination with Merck & Co.'s KEYTRUDA® (pembrolizumab) in patients with advanced lung cancer. The grant from Innovation Norway is an Industrial Development Award (IFU). The IFU program is directed to Norwegian companies developing new products or services in collaboration with foreign companies.
BerGenBio has by end of 2020 recognized and received the total grant of NOK 24 million. The grant may be withdrawn under certain circumstances.
R&D projects have been approved for SkatteFunn (a Norwegian government R&D tax incentive program designed to stimulate R&D in Norwegian trade and industry) for the period from 2021 until the end of 2023. The Group has recognized NOK 3.6 million in Q3 2022 (Q3 2021: NOK 0.0 million) classified partly as reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
BerGenBio Limited, a 100% subsidiary of BerGenBio ASA, has been granted R&D tax grants in UK from 2017. R&D grants are approved retrospect by application. The Group has in first nine months 2022 recognized NOK 0.0 (first nine months year 2021: NOK 0.0 mill).
| (NOK 1000) | Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 |
|---|---|---|---|---|
| Program expenses, clinical trials and research | 40,955 | 29,413 | 146,010 | 148,196 |
| Office rent and expenses | 977 | 623 | 2,699 | 1,618 |
| Consultants R&D projects | 1,467 | 2,507 | 5,686 | 10,330 |
| Patent and licence expenses | 1,288 | 1,496 | 4,626 | 5,570 |
| Other operating expenses | 4,741 | 11,516 | 22,389 | 23,006 |
| Government grants | -1,242 | -578 | -4,069 | -1,730 |
| Total | 48,186 | 44,977 | 177,342 | 186,990 |
| Q3 2022 | Q3 2021 | YTD 2022 | YTD 2021 | |
|---|---|---|---|---|
| Loss for the period (NOK 1,000) | -59,520 | -70,498 | -224,702 | -240,598 |
| Average number of outstanding shares during the period |
88,660,532 | 88,081,614 | 88,628,391 | 87,801,061 |
| Earnings (loss) per share - basic and diluted (NOK) |
-0.67 | -0.80 | -2.54 | -2.74 |
Share options issued have a potential dilutive effect on earnings per share. No dilutive effect has been recognized as potential ordinary shares only shall be treated as dilutive if their conversion to ordinary shares would decrease earnings per share or increase loss per share from continuing operations. As the Group is currently loss-making an increase in the average number of shares would have anti-dilutive effects.
| (NOK 1000) | 30 Sep 2022 | 30 Sep 2021 |
|---|---|---|
| Government grants | 8,189 | 2,959 |
| Refundable VAT | 134 | 0 |
| Prepaid expenses | 1,680 | 1,067 |
| Other receivables | 286 | 60 |
| Total | 10,289 | 4,086 |
| As of 30 September | Number of shares |
Nominal value (NOK) |
Book value (NOK) |
|---|---|---|---|
| Ordinary shares 2022 | 88,660,532 | 0.10 | 8,866,053.20 |
| Ordinary shares 2021 | 88,247,755 | 0.10 | 8,824,775.50 |
| Changes in the outstanding number of shares | YTD 2022 | YTD 2021 |
|---|---|---|
| Ordinary shares as of 1 January | 88,455,255 | 87,259,983 |
| Issue of ordinary shares | 205,277 | 977,772 |
| Ordinary shares as of 30 September | 88,660,532 | 88,247,755 |
| Shareholder | Number of shares |
% share of total shares |
|
|---|---|---|---|
| METEVA AS | 24,139,650 | 27.2 % | |
| INVESTINOR DIREKTE AS | 7,270,780 | 8.2 % | |
| FJARDE AP-FONDEN | 4,487,493 | 5.1 % | |
| SARSIA SEED AS | 2,117,900 | 2.4 % | |
| J.P. Morgan SE | NOMINEE I | 1,726,731 | 1.9 % |
| BERA AS | 1,712,426 | 1.9 % | |
| VERDIPAPIRFONDET NORDEA AVKASTNING | 1,510,174 | 1.7 % | |
| SARSIA DEVELOPMENT AS | 1,175,000 | 1.3 % | |
| VERDIPAPIRFONDET NORDEA NORGE PLUS | 909,260 | 1.0 % | |
| VERDIPAPIRFONDET NORDEA KAPITAL | 889,920 | 1.0 % | |
| VERDIPAPIRFONDET NORDEA NORGE VERD | 864,688 | 1.0 % | |
| MARIT MOHN | 850,000 | 1.0 % | |
| MARSTIA INVEST AS | 850,000 | 1.0 % | |
| VERDIPAPIRFONDET KLP AKSJENORGE IN | 568,766 | 0.6 % | |
| LOUISE MOHN | 509,676 | 0.6 % | |
| J.P. Morgan SE | NOMINEE II | 430,541 | 0.5 % |
| NORDNET LIVSFORSIKRING AS | 390,764 | 0.4 % | |
| HØSE AS | 383,111 | 0.4 % | |
| MP PENSJON PK | 372,783 | 0.4 % | |
| RO INVEST AS | 350,000 | 0.4 % | |
| Top 20 shareholders | 51,509,663 | 58.1 % | |
| Total other shareholders | 37,150,869 | 41.9 % | |
| Total number of shares | 88,660,532 | 100.0 % |
The Board of Directors has been granted a mandate from the general meeting held on 28 April 2022 to increase the share capital with up to NOK 883,605 by subscription of new shares. The power of attorney was granted for the purpose of issuance of new shares in accordance with the Company's share incentive program and is valid until the earlier of the annual general meeting in 2023 and 30 June 2023. See note 4 for more information about the share incentive program and number of option granted.
The Board of Directors has been granted a mandate from the general meeting held on 28 April 2022 to increase the share capital with up to NOK 1,773,210 by subscription of new shares. The proxy is valid until the earlier of the annual general meeting in 2023 and 30 June 2023.
| Position | Employed since | 30 Sep 2022 | 30 Sep 2021 | |
|---|---|---|---|---|
| Martin Olin | Chief Executive Officer |
September 2022 | 37,100 | 0 |
| Total shares held by management | 37,100 | 0 |
| Position | Served since | 30 Sep 2022 | 30 Sep 2021 | |
|---|---|---|---|---|
| Anders Tullgren | Chairman | January 2022 | 50,000 | 0 |
| Sveinung Hole 1) | Board member | September 2010 | 107,394 | 107,394 |
| Total shares held by members of the Board of Directors | 157,394 | 107,394 |
1) Sveinung Hole holds 104,444 shares in the Company through Svev AS, a wholly owned company of Sveinung Hole, and 2,950 shares directly.
Pension
BerGenBio ASA is required to have an occupational pension scheme in accordance with the Norwegian law on required occupational pension ("lov om obligatorisk tjenestepensjon").
The Company has a pension scheme which complies with the Act on Mandatory company pensions.
| ACCORD | Accelerating COVID-19 Research & Development |
|---|---|
| AML | Acute Myeloid Leukaemia. |
| Anti-AXL MAb | Anti-AXL Monoclonal antibody. A monoclonal antibody that recognises AXL and binds to the AXL receptor blocking its function. |
| Antibody | Proteins produced by the B Lymphocytes of the immune system in response to foreign proteins called antigens. Antibodies function as markers, biding to the antigen so that the antigen molecule can be recognized and destroyed. |
| ASCO | American Society of Clinical Oncology |
| ASH | American Society of Hematology |
| AXL | Cell surface expressed receptor tyrosine kinase, being an essential mediator of the EMT programme. AXL is up-regulated in a variety of malignancies and associated with immune evasion, acquired drug resistance and correlates with poor clinical prognosis. |
| Anti-AXL MAb | AXL Monoclonal antibody. A monoclonal antibody that recognises AXL and binds to the AXL receptor. |
| Anti-PD-1 | Agent that is used to inhibit the PD-1 receptor |
| Bemcentinib | BerGenBio's lead drug candidate; a highly selective inhibitor of AXL currently undergoing Phase Ib/II clinical trials in a range of aggressive cancers. |
| Biomarkers | A measurable indicator of some biological state or condition. More specifically, a biomarker indicates a change in expression or state of a protein that correlates with the risk or progression of a disease, or with the susceptibility of the disease to a given treatment. |
| cAXL | Composite AXL |
| CDx | Companion diagnostics |
| Checkpoint inhibitors | The immune system depends on multiple checkpoints to avoid overactivation of the immune system on healthy cells. Tumour cells often take advantage of these checkpoints to escape detection by the immune system. Checkpoint inhibitors, inhibit these checkpoints by "releasing the brakes" on the immune system to enhance an anti-tumour T-cell response. |
| Clinical Research | The research phases involving human subjects. |
| Clinical Trials | Clinical Trials are conducted with human subjects to allow safety and efficiency data to be collected for health inventions (e.g., drugs, devices, therapy protocols). There trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety, and Health Authority/Ethics Committee approval is granted in the country where the trial is taking place. |
| CPI | Immune checkpoint inhibitor |
| CR | Complete response |
| CRi | Complete response with incomplete recovery of peripheral counts |
| CRO | Contract research organisation. |
| DCR | Disease control rate |
| Docetaxel | A clinically well-established anti-mitotic chemotherapy medication that works by interfering with cell division. |
| EHA | European Hematology Association |
| Epithelial state | A state of the cell where the cells are stationary, typically forming layers and tightly connected and well ordered. They lack mobility tending to serve their specific bodily function by being anchored in place. |
| EGFR inhibitors | Epidermal growth factor receptor inhibitors. EGFRs play an important role in controlling normal cell growth, apoptosis and other cellular functions, but mutations of EGFRs can lead to continual or abnormal activation of the receptors causing unregulated EGFR inhibitors are either tyrosine kinase inhibitors or monoclonal antibodies that slow down or stop cell growth. |
| EMT | Epithelial-mesenchymal transition, a cellular process that makes cancer cells evade the immune system, escape the tumour and acquire drug resistant properties. |
| EMT inhibitors | Compounds that inhibit AXL and other targets that in turn prevent the formation of aggressive cancer cells with stem-cell like properties. 23 |
| ESMO | European Society for Medical Oncology |
|---|---|
| The EU-SolidAct trial is part of EU-RESPONSE, a pan-European research project involved with rapid | |
| EU-SolidAct | and coordinated investigation of new and repurposed medication to treat Covid-19 during the ongoing pandemic. EU-SolidAct is an Adaptive Platform Trial. |
| FDA | Food and Drug Administration |
| Glioblastoma | Is the most aggressive of the gliomas, a collection of tumours arising from glia or their precursors within the central nervous system. Gliomas are divided into four grades, grade 4 or glioblastoma multiforme (GBM) is the most aggressive of these and is the most common in humans. |
| HR-MDS | High Risk Myelodysplastic Syndromes |
| IHC | Immunohistochemistry |
| In vivo | Studies within living organisms. |
| In vitro | Studies in cells in a laboratory environment using test tubes, petri dishes etc. |
| MAb | Monoclonal antibodies. Monospecific antibodies that are made by identical immune cells that are all clones of a unique parent cell, in contrast to polyclonal antibodies which are antibodies obtained from the blood of an immunized animal and thus made by several different immune cells. |
| MDS | Myelodysplastic Syndrome |
| Mesenchymal state | A state of the cell where the cells have loose or no interactions, do not form layers and are less well ordered. They are mobile, can have invasive properties and have the potential to differentiate into more specialised cells with a specific function. |
| Mesenchymal cancer cells | Cancer cells in a mesenchymal state, meaning that they are aggressive with stem-cell like properties. |
| Metastatic cancers | A cancer that has spread from the part of the body where it started (the primary site) to other parts of the body. |
| Myeloid leukaemia | A type of leukaemia affecting myeloid tissue. Includes acute myeloid leukaemia (AML) and chronic myelogenous leukaemia. |
| NSCLC | Non-small cell lung cancer. |
| ORR | Overall response rate |
| PDAC | Pancreatic ductal adenocarcinoma is the most common type of pancreatic cancer and a notoriously lethal disease |
| PD-1 | Programmed death 1 |
| PD-L1 | Programmed death-ligand 1 |
| PFS | Progression-free survival |
| Phase I | The phase I clinical trials where the aim is to show that a new drug or treatment, which has proven to be safe for use in animals, may also be given safely to people. |
| Phase Ib | Phase Ib is a multiple ascending dose study to investigate the pharmacokinetics and pharmacodynamics of multiple doses of the drug candidate, looking at safety and tolerability. |
| Phase II | The phase II clinical trials where the goal is to provide more detailed information about the safety of the treatment and its effect. Phase II trials are performed on larger groups than in Phase I. |
| Phase III | In the phase III clinical trials data are gathered from large numbers of patients to find out whether the drug candidate is better and possibly has fewer side effects than the current standard treatment. |
| PR | Partial Response |
| Receptor tyrosine kinase | High-affinity cell surface receptors for many polypeptide growth factors, cytokines and hormones. Receptor tyrosine kinases have been shown not only to be key regulators of normal cellular processes but also to have a critical role in the development and progression of many types of cancer. |
| RECIST | Response Evaluation Criteria In Solid Tumors, a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. |
| R/R | Relapsed/Refractory |
| SARS-CoV-2 | Severe acute respiratory syndrome coronavirus 2 |
| sAXL | Soluble AXL |
| SITC | Society for Immunotherapy of Cancer |
| SoC | Standard of care |
| Small molecule | A small molecule is a low molecular weight (<900 Daltons) organic compound that may help regulate a biological process, with a size on the order of 10-9m. |
| Tilvestamab | Former BGB149, BerGenBio's AXL inhibitor antibody. |
| UKRI | UK Research and Innovation |
| WCLC | World Conference on Lung Cancer |
Jonas Lies vei 91, 5009 Bergen, Norway Telephone: + 47 53 50 15 64 E-mail: [email protected] Investor Relations [email protected]m
Graham Morrell Head of IR
Martin Olin CEO
Rune Skeie CFO
Joseph Pantginis Telephone: +1 646 975 6968 E-mail:[email protected]m
Telephone: +47 977 66 583 E-mail: geir.hiller.holom@dnb.no
Patrik Ling
Telephone: +46 8 473 48 43 E-mail: patrik.ling@dnb.se
Arvid Necander Telephone: +46 8 5886 8846 E-mail: arvid.necander@carnegie.se
Ulrik Trattner Telephone: +46 8 5886 8589 E-mail: ulrik.trattner@carnegie.se
This Report contains certain forward-looking statements relating to the business, financial performance and/or results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words "believes", expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. The forward-looking statements contained in this Report, including assumptions, opinions and views of the Company or cited from other sources are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. None of the Company or any of their parent or subsidiary undertakings or any such person's officers or employees provides any assurance that the assumptions underlying such forward-looking statements are free from errors nor do any of them accept any responsibility for the future accuracy of the opinions expressed in this Presentation or the actual occurrence of the forecasted developments. The Company assumes no obligation, except as required by law, to update any forward-looking statements or to conform these forward-looking statements to our actual results.
Telephone: + 47 535 01 564 E-mail: [email protected]
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