Total nine-month revenues of €249.9 million, a ~ 3.5-fold increase compared to 2021
- Product sales of €74.4 million (vs €45.5 million in the first nine months of 2021) driven by a continued recovery of travel vaccine sales and by COVID-19 vaccine sales in
Europe . Product sales outside of COVID-19 grew by double digits (11.2%) vs. prior period - €175.5 million of other revenues (vs €24.4 million in the first nine months of 2021) mainly driven by revenue recognition related to previous COVID-19 vaccine supply agreements
Cash and cash equivalents of €261.0 million at the end of
- Excludes €102.9 million of gross proceeds received in
October 2022 from an upsized global offering1 - Includes drawing the final tranche (
$20 million ) from Deerfield & Orbimed loan agreement2
Continued progression of late-stage clinical programs as guided
Lyme Disease Vaccine Candidate VLA15
- Phase 3 study recruitment ongoing; enrollment completion expected in the second quarter of 2023
Single-Shot Chikungunya Vaccine Candidate VLA1553
- Ongoing rolling submission for Biologics License Application (BLA) with the
U.S. Food and Drug Administration (FDA); submission completion expected by end of 2022
Progression of pre-clinical assets and focus on strengthening the Company’s clinical pipeline
- VLA1554 (human metapneumovirus) and VLA2112 (Epstein-Barr virus) currently prioritized
Updated FY 2022 Financial Guidance
Valneva reiterates expected total revenues of €340 million to €360 million, noting continued recovery of travel vaccine sales, further revenue recognition linked to payments received under the Advance Purchase Agreement (APA) with each of theEuropean Commission (EC) andUnited Kingdom (UK ) and the expected sales from the revised EC APA.- Product sales of the Company’s travel vaccines are still expected to reach €70 million to €80 million despite supply challenges and COVID-19 product sales are expected to reach €30 million to €40 million.
- Other Revenues are expected to reach approximately €240 million. They will be mainly related to COVID-19 revenue recognition in relation to the
UK and EC APAs and will have no impact on cash. Other Revenues not related to COVID-19 will be negative in 2022 due to the increased refund liability resulting from the amendment of the VLA15 collaboration and license agreement with Pfizer.
- Given phasing of clinical trial expenses and accelerated wind-down of VLA2001 related activities,
Valneva now expects lower R&D expenses of €95 million to €110 million compared to the €120 million to €135 million previously communicated. The Company remains committed to advancing its late-stage vaccine candidates and to further expanding its R&D pipeline, including, but not limited to, through the advancement of some of the Company’s pre-clinical candidates towards clinical entry. - As part of the communicated reshape strategy,
Valneva is in the process of re-sizing its operations which is expected to result in a reduction of approximately 20% to 25% of its existing workforce. Post restructuring, the Company’s total workforce is expected to be approximately 25% above pre-COVID levels enabling the Company to retain key talents and additional expertise to successfully execute on its strategy. This re-sizing and re-focusing is expected to result in annualized savings of approximately €12 million.
Financial Information
(unaudited results, consolidated per IFRS)
€ in million | Nine months ending September 30 | |
2022 | 2021 | |
Total revenues | 249.9 | 69.8 |
Product sales | 74.4 | 45.5 |
Net loss | (99.1) | (245.9) |
Adjusted EBITDA loss | (38.0) | (227.6) |
Cash (at end of period) | 261.0 | 247.9 |
Saint-Herblain (
Thomas Lingelbach, Valneva’s Chief Executive Officer, commented, “
Clinical Stage Vaccine Candidates
LYME DISEASE VACCINE CANDIDATE – VLA15
Phase 3 study initiated
Recruitment of approximately 6,000 participants five years of age and older for the Phase 3 clinical study “VALOR” (Vaccine Against Lyme for Outdoor Recreationists) is currently ongoing in highly endemic regions in
Pending successful Phase 3 completion, Pfizer could potentially submit a Biologics License Application (BLA) to the
If approved, Pfizer will commercialize VLA15 and
CHIKUNGUNYA VACCINE CANDIDATE – VLA1553
BLA rolling submission with
VLA1553 is a live-attenuated, single-dose vaccine candidate against the chikungunya virus (CHIKV), a mosquito-borne virus that has spread to more than 120 countries with the potential to rapidly expand further. There are currently no preventive vaccines or effective treatments for the chikungunya virus available, and VLA1553 is currently the only chikungunya vaccine candidate that successfully completed pivotal Phase 3 studies6,7 and the first chikungunya vaccine candidate for which a regulatory filing process has been initiated with the
At the recent meeting of the
A clinical trial of VLA1553 in adolescents is also ongoing in
Pre-Clinical Vaccine Candidates
The Company continues to progress select pre-clinical assets and focus on strengthening its future clinical pipeline. The Company is currently focused on two pre-clinical assets, VLA1554 and VLA2112. The hMPV candidate, VLA1554, is a pre-fusion recombinant protein subunit vaccine targeting the human metapneumovirus (hMPV), which is a major worldwide respiratory pathogen that causes acute upper and lower respiratory tract infection in children and is a common cause of morbidity and mortality in immunocompromised patients and in older adults. VLA1554 is currently in pre-clinical proof of concept studies. VLA2112 is a vaccine candidate targeting the Epstein-Barr virus (EBV), which is one of the most common human viruses and can cause infectious mononucleosis and other illnesses. VLA2112 is currently in a late-stage evaluation phase.
Commercial Vaccines
JAPANESE ENCEPHALITIS VACCINE (IXIARO®/JESPECT®)
IXIARO® is the only Japanese encephalitis vaccine licensed and available in the
In the first nine months of 2022, IXIARO®/JESPECT® sales were €22.9 million compared to €33.7 million in the first nine months of 2021, as a result of the planned delivery schedule to the
CHOLERA / ETEC15-DIARRHEA VACCINE (DUKORAL®)
DUKORAL® is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and/or heat-labile toxin producing ETEC16, the leading cause of travelers’ diarrhea. DUKORAL® is authorized for use in the
In the first nine months of 2022, DUKORAL® sales increased to €9.2 million compared to €0.5 million in the first nine months of 2021, also benefitting from the significant recovery in the private travel markets.
SARS-CoV-2 INACTIVATED WHOLE-VIRUS VACCINE
Valneva’s COVID-19 vaccine, VLA2001, is the only inactivated whole-virus COVID-19 vaccine approved in
In addition to its marketing approval in
Following a revised purchase agreement with the EC in
Subject to regulatory assessments, heterologous booster results may support label extensions for VLA2001, additional product approvals and/or additional scientific recommendations.
In light of the reduced order volume from EU Member States,
THIRD-PARTY DISTRIBUTION
3-antigen Hepatitis B vaccine, PreHevbri®, in select European markets23.
In the first nine months of 2022, third party product sales increased by 64.6% to €18.4 million from €11.2 million in the first nine months of 2021.
Nine-Month 2022 Financial Review
(Unaudited, consolidated under IFRS)
Revenues
Valneva’s total revenues were €249.9 million in the first nine months of 2022 compared to €69.8 million in the first nine months of 2021, an increase of 257.8%.
Product sales, including COVID-19 vaccine sales, increased by 63.7% to €74.4 million in the first nine months of 2022 compared to €45.5 million in the first nine months of 2021. Foreign currency fluctuations contributed positively to €4.9 million of the change in product sales. Product sales from commercial products amounted to €50.6 million in the first nine months of 2022, an increase of 11.2% compared to the first nine months of 2021. Product sales related to COVID-19 amounted to €23.9 million.
IXIARO®/JESPECT® sales decreased by 32.1% to €22.9 million in the first nine months of 2022 compared to €33.7 million in the first nine months of 2021, primarily as a result of the planned delivery schedule to the
Other Revenues, including revenues from collaborations, licensing and services, amounted to €175.5 million in the first nine months of 2022 compared to €24.4 million in the first nine months of 2021. This increase is attributable to €89.4 million of released refund liability as a result of the settlement with the
Operating Result and adjusted EBITDA
Costs of goods and services sold (COGS) were €202.7 million in the first nine months of 2022. The gross margin on commercial product sales amounted to 55.4% compared to 37.8% in the first nine months of 2021. COGS of €6.4 million related to IXIARO® product sales, yielding a product gross margin of 72.0%. COGS of €3.7 million related to DUKORAL® product sales, yielding a product gross margin of 60.0%, which was positively impacted by provision releases resulting from reduced expiry risks on inventory. Of the remaining COGS in the first nine months of 2022, €12.4 million were related to the Third-Party products distribution business, €174.0 million to the COVID-19 vaccine business and €6.2 million to cost of services. COGS of the COVID-19 vaccine program included effects from the significant reduction of sales volumes to EU Member States. In the first nine months of 2021, overall COGS were €159.6 million, of which €142.4 million related to cost of goods and €17.2 million related to cost of services.
Research and development expenses amounted to €75.4 million in the first nine months of 2022, compared to €117.2 million in the first nine months of 2021. This decrease was mainly driven by lower clinical trials costs for Valneva’s chikungunya vaccine program advancing towards licensure as well as reduced spend on the COVID-19 program. Marketing and distribution expenses in the first nine months of 2022 amounted to €13.1 million compared to €15.0 million in the first nine months of 2021. Marketing and distribution expenses in the first nine months of 2022 notably included €4.3 million of expenses related to the launch preparation costs for Valneva’s chikungunya vaccine candidate, VLA1553, compared to €2.8 million in the first nine months of 2021. In the first nine months of 2022, general and administrative expenses declined to €23.3 million from €31.7 million in the first nine months of 2021. COGS, research and development, marketing and distribution as well as general and administrative expenses benefited from a non-cash accrual adjustment of €30.6 million related to the positive effect of the Company’s share price development on the employee share-based compensation programs. This income compares to a cost of €13.7 million in the first nine months of 2021.
Other income, net of other expenses, reduced to €7.5 million in the first nine months of 2022 from €16.0 million in the first nine months of 2021. This decrease was mainly driven by reduced R&D tax credits directly resulting from lower R&D spending and an increase of other expenses related to the provision for the ongoing
Net Result
In the first nine months of 2022,
Finance expense and foreign currency effects in the first nine months of 2022 resulted in a net finance expense of €39.8 million, compared to a net finance expense of €6.6 million in the first nine months of 2021. This was mainly a result of a foreign exchange loss amounting to €26.5 million in the first nine months of 2022, primarily driven by non-cash revaluation results of non-Euro denominated balance sheet positions, compared to a net foreign exchange gain of €5.3 million in the first nine months of 2021. Interest expenses net of interest income were €13.3 million in the first nine months of 2022 compared to €11.9 million in the first nine months of 2021.
Cash Flow and Liquidity
Net cash used in operating activities amounted to €189.5 million in the first nine months of 2022 compared to €36.5 million of cash generated by operating activities in the first nine months of 2021. Cash outflows in the first nine months of 2022 were mainly related to the operating loss generated in the period and non-cash revenues (cash received in previous periods), while during the first nine months of 2021 cash inflows mainly resulted from pre-payments received related to the vaccine supply agreement signed with the
Cash outflows from investing activities amounted to €22.5 million in the first nine months of 2022 compared to €69.9 million in the first nine months of 2021, both mainly a result of COVID-19-related construction activities across production sites in
Net cash generated from financing activities amounted to €121.6 million in the first nine months of 2022, which was mainly a result of proceeds from the equity subscription agreement with Pfizer as well as a draw-down in September on the credit facility provided by Deerfield & Orbimed24. Cash inflows in the first nine months of 2021 amounted to €74.6 million which was mainly a result of proceeds from issuance of new shares in the
Cash and cash equivalents decreased to €261.0 million as of
Non-IFRS Financial Measures
Management uses and presents IFRS results, as well as the non-IFRS measure of Adjusted EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition.
Adjusted EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tools. Adjusted EBITDA is defined as earnings (loss) for the period before income tax, finance income/expense, foreign exchange gain/(loss), results from investments in associates, amortization, depreciation, and impairment.
A reconciliation of Adjusted EBITDA to net loss for the period, which is the most directly comparable IFRS measure, is set forth below:
€ in million | Nine months ending September 30 | |
(unaudited results, consolidated per IFRS) | 2022 | 2021 |
Loss for the period | (99.1) | (245.9) |
Add: | ||
Income tax expense | 2.2 | 1.6 |
Total Finance income | (0.1) | (0.2) |
Total Finance expense | 13.4 | 12.1 |
Foreign exchange gain/(loss) – net | 26.5 | (5.3) |
Result from investments in associates | - | 0.1 |
Amortization | 5.3 | 4.9 |
Depreciation | 10.6 | 5.1 |
Impairment | 3.3 | - |
Adjusted EBITDA | (38.0) | (227.6) |
About
Valneva Investor and Media Contacts VP, M +33 (0)6 4516 7099 investors@valneva.com | VP, Global Investor Relations M +001 917 815 4520 joshua.drumm@valneva.com | | |
Forward-Looking Statements
This press release contains certain forward-looking statements relating to the business of
1Valneva Announces Closing of Upsized €102.9 Million Global Offering -
2 Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed -
3Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15 -
4
5
6Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate –
7Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate -
8 Valneva Initiates Rolling Submission of FDA Biologics License Application for its Single-Shot Chikungunya Vaccine Candidate -
9Valneva Reports Positive End-of-Phase 2 Chikungunya Meeting with the
10Valneva Successfully Completes Pivotal Phase 3 Trial of Single-Shot Chikungunya Vaccine Candidate –
11Valneva Successfully Completes Lot-to-Lot Consistency Trial for its Single-Shot Chikungunya Vaccine Candidate -
12
13 Presentation at ASTMH: Chikungunya: Phase 3 Clinical Development of a Single-shot Live-Attenuated Vaccine
14Valneva Announces Initiation of Adolescent Phase 3 Trial for its Single-Shot Chikungunya Vaccine Candidate –
15 Indications differ by country - Please refer to Product / Prescribing Information (PI) / Medication Guide approved in your respective countries for complete information, incl. dosing, safety and age groups in which this vaccine is licensed, ETEC = Enterotoxigenic Escherichia coli (
16 Enterotoxigenic Escherichia coli (ETEC) is a type of Escherichia coli and one of the leading bacterial causes of diarrhea in the developing world, as well as the most common cause of travelers’ diarrhea.
17Valneva Receives Marketing Authorization in
18Valneva Receives Conditional Marketing Authorization from
19Valneva Receives Emergency Use Authorization from the
20Valneva Receives Emergency Use Authorization from
21Valneva Confirms Amendment of Advance Purchase Agreement with
22 Valneva Reports Further Positive Phase 3 Immunogenicity and the First Heterologous Booster Results for its Inactivated, Adjuvanted COVID-19 Vaccine VLA2001 -
23
24 Valneva Announces Upsized Financing Arrangement with Leading US Healthcare Funds Deerfield and OrbiMed -
Attachment
- 2022_11_10_VLA_Nine-Month_PR_EN_Final
Source:
2022 GlobeNewswire, Inc., source