VALNEVA Revenues and grants increased by 96% year-on-year and amounted to
€83.3 million in 2015 (vs €42.4 million in 2014); Q4 2015 revenues and grants were €22.7 million (vs €13.1 million in Q4 2014);
Revenue growth driven mainly by the inclusion of acquired DUKORAL®vaccine and activities in Sweden as well as continued strong product sales of IXIARO®/JESPECT®;
Cash position at the end of 2015 was €42.6 million.
2016 OutlookRevenues, including grants, expected to reach €90 to €100 million. This includes product sales in the expected range of €70 to €80 million, reflecting up to 30% growth compared to 2015 product sales;
Revenue growth to be driven by expected IXIARO®/JESPECT®product sales of approximately €50 million (from €30.6 million in 2015);
Expected gross margin on product sales of approximately 50%;
EBITDA loss expected to be reduced to less than €5 million.
Significant pipeline catalysts in 2016Valneva expects to release the results of its Pseudomonas aeruginosa Phase II/III trial in the second quarter of 2016;
The Company reported positive Phase II top-line data for its Clostridium difficile vaccine and aims for a Phase III partnership agreement in 2016;
Valneva's new Lyme borreliosis vaccine candidate is expected to enter Phase I clinical trials in the second half of 2016.
Key financial information
in million € | 3 months ended Dec 31, | 12 months ended Dec 31, | ||
2015 unaudited | 2014 | 2015 unaudited | 2014 | |
Product sales | 17.4 | 8.8 | 61.5 | 28.1 |
Revenues from collaborations and licensing | 3.6 | 2.7 | 16.8 | 8.8 |
Grant income | 1.7 | 1.6 | 5.0 | 5.5 |
Total revenues & grants | 22.7 | 13.1 | 83.3 | 42.4 |
Cash, short-term deposits and marketable securities, end of period | 42.6 | 29.5 | 42.6 | 29.5 |
Business highlights
In 2015, IXIARO®/JESPECT®product sales increased to €30.6 million compared to
€28.1 million in 2014, representing an 8.8% year-on-year growth which was supported by robust fourth quarter sales of €5.9 million. IXIARO®/JESPECT®recent sales performance exceeded the Company's prior expectations which had been lowered following the decision to terminate the Marketing and Distribution agreement with the Company's global distributor and to establish a new marketing and distribution network for this vaccine. The expected impact on sales as a result of the transition did not materialize owing to very collaborative and professional transition work with the Company's previous global distribution partner and to substantial in-market sales growth in 2015. Valneva expects the IXIARO®/JESPECT®product sales to grow to approximately €50 million in 2016 as a result of the new commercialization strategy and a continued increase in product adoption by travelers.
With the goal of complementing its own commercial sales infrastructure, Valneva has entered into a number of country-specific marketing and distribution agreements to ensure broad geographic availability of its products through leading local distribution partners including VaxServe, Inc., a Sanofi Pasteur company (US private market) and GlaxoSmithKline (GSK) (Germany / Austria).
More than 60% of the planned IXIARO®and DUKORAL®sales in 2016 are expected to be generated by Valneva's own commercial teams.
Valneva's 2015 DUKORAL®product sales, which were included from the acquisition date on February 10, 2015, reached €21.0 million, of which €8.7 million came from
the seasonally strong fourth quarter. The product which is highly complementary to Valneva's first marketed product was added through the acquisition of Crucell Sweden AB in February 2015. DUKORAL®pro forma 2015 product revenues, for the entire 12 month period, were €26.3 million, representing a 2.7% growth over 2014 pro forma sales of €25.6 million under the previous owner. By achieving sales growth despite the integration and transition impact, DUKORAL®confirmed Valneva's expectations in its potential and strategic value for the Company.
In December 2015, Valneva announced that Health Canada had requested changes to the DUKORAL®product monograph. The updated product monograph and subsequent labeling refer to the "Prevention of diarrhea caused by cholera and/or LT-ETEC". LT-ETEC is the heat-labile toxin producing Enterotoxigenic Escherichia coli. Enterotoxigenic Escherichia coli (ETEC) is a type of Escherichia coli and the leading bacterial cause of diarrhea in the developing world, as well as the most common cause of travelers' diarrhea. The updated product indication may negatively impact DUKORAL®sales in Canada going forward. Canada is the single most important market for the product, accounting for more than 50% of 2015 global DUKORAL®sales.
In order to reflect the business changes resulting from the adjustments to the DUKORAL®label in Canada, the seller Crucell Holland BV and Valneva agreed on certain amendments to the purchase agreement including an adjustment to the purchase price. Crucell Holland BV waived a €10 million milestone payment that Valneva would otherwise have been obligated to pay and repaid €15 million from the acquisition price. Together, the €10 million milestone waiver and the €15 million cash repayment resulted in a €25 million reduction of the purchase consideration, bringing it from originally €45 million down to €20 million. Valneva used the €15 million repayment amount to fully repay a loan which had been granted by Athyrium Capital Management LLC ("Athyrium") for purposes of this acquisition. Crucell Holland BV also paid for prepayment fees owed to Athyrium (€3 million). Following this repayment, Athyrium resigned its position as observer to the Company's supervisory board.
Valneva will continue to invest in growing the DUKORAL®vaccine by way of promotional efforts and geographic expansion and to leverage its strategic value for the Group.
Through the acquisition of Crucell Sweden AB in February 2015, Valneva also acquired a vaccine distribution business in Sweden. Valneva´s commercial team in the Nordics marketed and distributed DUKORAL®and a range of third party products in 2015 which generated sales of €9.9 million, including €2.8 million in the fourth quarter of 2015. Since a number of vaccines, representing more than 60% of the third party business, will no longer be marketed and distributed by Valneva following the transfer of the Novartis vaccines business to GSK, third party product sales are expected to fall significantly behind the previous year's level. Valneva expects that new third party distribution agreements will be entered into in the course of the year.
Vaccine Candidates
Currently, there are no approved prophylactic vaccines for Pseudomonas aeruginosa, and Valneva's VLA43 is the only vaccine in development. Valneva has completed enrolment of its phase II/III efficacy trial with a total of 800 ventilated intensive care unit patients recruited across approximately 40 different study sites. Valneva will release data, including day 180 follow-up time-points, in the second quarter of 2016. The development of Valneva's vaccine candidate against Pseudomonas aeruginosa is part of the strategic alliance agreement signed between Valneva and Novartis in 2007, which transitioned to GSK in 2015. The current trial is co-financed by GSK.
Final study results expected in Q2 leading to potential partnership agreement In December 2015, Valneva reported positive topline data from its Phase II trial evaluating VLA84 as a prophylactic vaccine for Clostridium difficile (C. difficile) infections. Valneva expects to report final study results in the second quarter of 2016. Following that step, GSK will have an opportunity to exercise their opt-in rights for the VLA84 development program. Valneva is in discussions with other potential partners in case GSK chooses not to pursue the program.
Technologies and services
EB66®CELL LINEAt the beginning of February, Valneva announced the signing of a new R&D collaboration agreement with GSK for the development of EB66®-based influenza vaccines. Under the new agreement, Valneva secured additional research fees in addition to the potential milestone payments and royalties that were included in the 2007 agreement signed with GSK. GSK is developing its EB66®-based influenza vaccines in the US in partnership with the Texas A&M University System.
In 2015, Valneva signed 10 new agreements on its EB66®platform (5 research agreements and 5 commercial agreements), including an exclusive agreement with Jianshun Biosciences Ltd (JSB) granting this Chinese company rights to commercialize the EB66®cell line in People's Republic of China. Under the JSB agreement, Valneva received a €2.5 million upfront payment and is entitled to further annual license fees and royalties.
Valneva SE issued this content on 24 February 2016 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 24 February 2016 08:22:28 UTC
