• Significant revenue growth, EUR 36.9 million compared to EUR 0.7 million in 2014
• Promising clinical results, including the achievement of keys milestones in the development of our projects
• Strengthened organization and creation of a US-based subsidiary
• Positive net result of EUR 12.6 million (compared to a net loss of EUR 20,7 million last year)
• Solid cash position of EUR 72 million as of December 31, 2015
Lyon, France, March 16, 2016 - ADOCIA (Euronext Paris: FR0011184241 – ADOC) announces today its financial results for 2015. The financial statements were approved by the board of directors on March 15th, 2016 and will be submitted to the shareholders for approval at the next general meeting on June 21st, 2016.
“2015 was marked by several clinical successes for our projects. These good results coincide with our 10th anniversary and reflect the maturity of our company. Beyond the development of our projects, Adocia has become a center of excellence in diabetes-focused innovation, thanks to its research team including more than 40 Ph.Ds. The incorporation of a subsidiary in the USA also allows us to access the best global experts as well as the US financial place.” commented Gérard Soula, President and CEO of Adocia. “Today, we have adequate financial resources to work serenely for several years and we are confident in the value of our products, based on the clinical results obtained.”
A conference call will be held on Thursday March 17, 2016 at 6 PM (CET) Dial in number: (+33) 1 70 77 09 27 An audio file and a transcript in English will be available on the website of the Company: www.adocia.com The results of the Company for 2015 are characterized by:
• A strengthened cash position of EUR 72 million , compared to EUR 49.8 million as of December 2014, as a result of the EUR 30 million increase (net of fees) in capital realized in March 2015 from a private placement and the receipt of a USD 10 million (EUR 9.2 million) milestone payment from Eli Lilly and Company (Lilly) in December.
In 2015, the net cash needed to finance operations amounted to EUR 15.3 million compared to EUR 10.6 million last year. • A positive net result of EUR 12.6 million , compared to EUR 20.7 million net loss for 2014, mainly constituted by :
• Revenue close to EUR 37 million in 2015 (compared to EUR 0.7 million in 2014) which primarily results from the research and collaborative contract signed with Eli Lilly.
o EUR 10.7 million for amortization of the initial payment (non-cash) received in December 2014 upon signing of the contract,
o EUR 9.2 million related to milestone payment for BioChaperone Lispro U200,
o EUR 17 million for the financial coverage by the partner of project-related expenses,
• Other operating income of EUR 7.8 million, of which EUR 6.8 million in research tax credit (“Crédit d’impôt recherche”) calculated on 2015 expenses,
• Operating expenses of EUR 34.7 million (compared to EUR 21.3 million in 2014) of which 82% are dedicated to research and development activities.
The increase in expenses is mainly related to an increase in external expenses by EUR 11.8 million between 2015 and 2014, in order to support the preparation and the conduct of clinical trials over the year.
The EUR 1.6 million increase in staff costs between 2014 and 2015 resulted from staff recruitment and staff costs (including payments in shares).
• A fiscal tax loss (by French standards) leading to the absence of taxes.
“In 2015, we controlled our expenses, 82% of which were dedicated to R&D, while we actively developed our projects and strengthened our organization. Besides, the strong growth in revenues as well as the private placement reinforced our cash position to reach close to 72 million euros as of end of December. This strong cash position allows us to continue this positive momentum to support the growth of the Company” commented Valerie Danaguezian, Chief Financial Officer of Adocia.
Key events in 2015:
• Intensive activity within the Lilly partnership
2014 ended with the signing of a major license agreement with Eli Lilly for the development of BioChaperone Lispro, an ultra-rapid insulin lispro formulation using the with BioChaperone® technology.
2015 was marked by an intense activity within this partnership, including the launch, on January 20th, of a clinical trial measuring the effect of ultra-fast insulin BioChaperone Lispro on glycemic control after the meal. After the publication, end of June 2015, of positive results from this trial, three additional trials were launched in the second half year:
• a phase 1b study of repeated administration of BioChaperone Lispro in type 1 diabetic patients,
• a phase 1b study of repeated administration of BioChaperone Lispro in type 2 diabetic patients,
• a phase 1b clinical trial realized in patients with type 1 diabetes using a pump.
Topline positive results from the first study were published on Monday, March 14, 2016 and the results of the two other studies are expected during the first half of 2016
In parallel with the U100 formulation, a formulation twice as concentrated, U200, was compared to the U100 formulation in a pilot bioequivalence study.The positive results from this trial, published in December, triggered a USD 10 million milestone payment from Lilly to Adocia. This is the first milestone payment received under the license agreement that provides for a total potential USD 520 million, if the product reaches certain clinical and regulatory milestones as well as certain sales targets.
• Major clinical progress throughout the product portfolio
The year 2015 was also marked by significant progress in the projects developed by Adocia on its own:
• BioChaperone Combo, the unique combination of long-acting insulin glargine and fast-acting insulin lispro. Two clinical trials were launched in 2015: the first one in 28 patients with type 1 diabetes comparing BioChaperone Combo with Humalog Mix 75/25, the second one in 24 patients with type 2 diabetes, comparing BioChaperon Combo with Humalog Mix 75/25 and separate injection of Lantus® and Humalog®.
Positive results obtained on these studies confirmed the value of BioChaperone Combo compared to both the premix and basal bolus regimens. Adocia actively pursues the clinical development of the product with new clinical trials expected to launch in 2016.
• BioChaperone human insulin (HinsBet): the results of the phase 2a clinical study published in February 2015 showed that HinsBet acted significantly faster than Humulin® and as fast as Humalog in the first hour, which is critical for glycemic control. Based on these results, the Company pursued the development and prepared the launch of a new study planned in the beginning of 2016.
• BioChaperone PDGF-BB: the phase 3 clinical trial was ongoing throughout 2015 with the enrollment and the treatment of 252 patients. Results are expected during the first half of 2016.
Besides, the Company continued to collaborate with major pharmaceutical companies by performing feasibility studies on innovative formulation of monoclonal antibodies and pursued its research activities on the Drive In platform.
• A strengthening of the organization and the sustainability of its facility
From an organizational perspective, Adocia entered a new phase in its development with the recruitment of 25 people in France and the creation of a subsidiary in the United States. Hiring mainly focused on R&D positions to support the development of projects. The US subsidiary is composed of a General Manager, Steve Daly, and a Chief Medical Officer, Dr. Simon Bruce.
In 2015, the Company expanded its premises and fitted nearly 700 m² of additional laboratory and office space, resulting to a 2 709 m² facility altogether.
With the aim to sustain its presence on this site, in the center of Lyon, the Company signed a preliminary sales agreement in January 2016 for the acquisition of this property of 7,120 m². The purchase price was fixed at 5 million euros, excluding VAT and registration fees. The Company plans to finance this acquisition by bank loan. The signing of the bill sale is expected in the coming weeks.
Perspectives for 2016:
Regarding the project in partnership with Lilly, BioChaperone Lispro, we expect during 2016 the results of the studies initiated in 2015 (phase 1b clinical study in patients with type 1 diabetes using an insulin pump and phase 1b clinical study of repeated administration in patients with type 2 diabetes) and January 2016 (phase 1 study evaluating BioChaperone Lispro in healthy Japanese subjects). Further development remains confidential.
Regarding BioChaperone Combo, Adocia intends to intensify the development and to push the product up to the entry in phase 3. In 2016, two clinical studies are planned on the first semester:
• a phase 1b/2a on type 2 diabetic patients treated with basal insulin in order to evaluate the performance of BioChaperone Combo injected once daily at steady-state,
• a phase 1b/2a on type 2 diabetic patients in order to compare the control of post-meal blood glucose of BioChaperone Combo compared to a premix.
Regarding HinsBet, a first clinical phase 1b/2a study in patients with type 1 diabetes is planned, aiming to measure the glycemic control at mealtime. This study is expected to start in the coming weeks.
Regarding the diabetic foot ulcer wound healing project, Adocia is pursuing a dual strategy. In India, the results of the ongoing phase 3 clinical study are expected mid-2016. In Europe and the United States, the aim is to prepare during the second half of 2016 two clinical phase 3 studies with a PDGF compliant to European and American quality standards, cGMP.
Lastly, Adocia is actively exploring new opportunities to use its BioChaperone platform in various therapeutic areas.
About ADOCIA
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins. Adocia’s insulin formulation portfolio, featuring four clinical-stage programs and one preclinical program, is among the largest and most differentiated in the industry.
The proprietary BioChaperone® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone to each protein for a given application in order to address specific patient needs.
Adocia’s clinical pipeline includes a unique formulation of PDGF-BB for the treatment of diabetic foot ulcer and four novel insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analogs (BioChaperone Lispro U100 and U200), a rapid-acting formulation of human insulin (HinsBet U100) and a combination of insulin glargine and a rapid-acting insulin analog (BioChaperone Combo). Adocia is also developing a concentrated, rapid-acting formulation of human insulin (HinsBet U500).
In December 2014, Adocia signed a partnership with Eli Lilly for the development and commercialization of the BioChaperone Lispro programs.
Adocia’s extended, early-stage programs include innovative monoclonal antibody formulations, featuring two ongoing collaborations programs with major pharmaceutical companies in the field, and the delivery of anticancer drugs using the proprietary Drive In ® nanotechnology platform.
Adocia aims to deliver “Innovative medicine for everyone, everywhere.”
To learn more about Adocia, please visit us at www.adocia.com
