Adocia announces financial results for 2013

Ad - Bora Pharmaceuticals

Adocia announces today its annual financial results for 2013. The financial statements were approved by the board of directors on March 21, 2014 and will be submitted to the shareholders for approval during the next general meeting on June 24, 2014.

Key events for year 2013:

Intensification of Adocia’s clinical program:

In 2013, Adocia intensified the clinical development of its products based on the proprietary BioChaperone(R) technology, with a particular focus on innovative insulin formulations.

The first accomplishment resulting from the work undertaken in 2013 relates to BioChaperone Combo, an innovative combination of long-acting insulin analog Glargine with fast-acting insulin analog Lispro. During the first quarter of 2014, Adocia achieved positive results for the first Phase I/II clinical study. The results showed how this combination has the potential to replace insulin premixes. This market is estimated to exceed USD 2 Billion. It also presents an opportunity to seize part of the Lantus market, with revenues of USD 7.8 Billion in 2013. A second clinical study is scheduled for the third quarter of 2014.

Another major event was the launch of a Phase IIa clinical study on Type I diabetic patients with BioChaperone Ultra-fast Lispro. Following the termination of the collaboration with Eli Lilly (announced in July 2013), and based on positive Phase I results obtained by Eli Lilly, Adocia accelerated clinical development of BioChaperone Ultra-fast Lispro. The next Phase IIa clinical results are expected during the second quarter of 2014. If successful, the value of the project should be significantly increased.

The company also continued the development of its third insulin project in 2013, with the formulation of a rapid-acting human recombinant insulin (HinsBet(R)), by working on an optimized formulation. The aim is to test it in a clinical trial during 2014.

Finally, Adocia is waiting for the approval of Indian authorities to start its Phase III clinical trial in India of its product for chronic wound healing, which specifically targets diabetic foot ulcer. Following a major reorganization of Indian regulatory authorities in 2013, the review of clinical trial approvals was suspended for few months. This interruption resulted in an important backlog which seems yet to be completely absorbed. However, Adocia is ready to initiate the clinical study as soon as it gets this approval. In January 2013, Adocia also solicited scientific advice from the European Medical Agency (EMA), which allowed it to validate the company’s clinical development plan for Europe. Specifically, the company should only perform one Phase III European clinical trial before the submission for marketing approval in Europe.

Project portfolio expansion through the acquisition of a new technology

In 2013, the company acquired an exclusive license from Universite de Bordeaux I, CNRS, Institut Polytechnique de Bordeaux and SATT Aquitaine on a novel nanotechnology called DriveIn(R). DriveIn is a nanotechnology to actively target solid tumors. The objective is to improve the efficacy of oncologic treatments such as doxorubicin or docetaxel. In parallel, Adocia will offer to partner this technology with major pharmaceutical companies to improve the delivery and efficacy of their proprietary molecules.

Strengthened patents portfolio

In 2013, Adocia strengthened its diabetic foot ulcer patent portfolio. The patent protecting the BioChaperone PDGF (Platelet Derived Growth Factor) composition was delivered in Japan in December 2013 (after being granted in the United States and Europe in 2012).

Key financial results for year 2013:

The key financial statements include:

Operational revenues that grew to EUR 8.8M in 2013, compared to EUR 7.2M  in 2012

Stable research and development expenses at EUR 11.5M compared to EUR 11.8M in 2012

A net loss of EUR 4.2M, compared to nearly EUR 6M during the preceding financial year

At December 31 2013, the company cash and cash equivalent amounted to EUR 19.4M.

The table below presents the 2013 income statement, with a comparison to 2012:

The consolidated annual IFRS financial statements as at December 31, 2013 as well as the management discussion on these results are presented in the appendix at the end of this document.

“2013 was a year of major accomplishments on our projects and important investments in clinical studies. The outcomes are key to the short and mid-term future of the company. The initiative we took on the ultra-fast acting Lispro project following the termination of our collaboration with Eli Lilly should see realization as soon as 2014,” said Gerard Soula, CEO of Adocia. “Through the acquisition and development of a new technology, we have strengthened our portfolio and taken the opportunity to enter oncology, with the ambition to improve the efficacy of existing treatments. We are confident that this acquisition can become a new lever of mid-term growth for the company. We step into 2014 with enthusiasm, fully supported by the clinical results we just obtained on our BioChaperone Combo.”

“Our burn rate was limited to EUR 11M in 2013. Our cash position of EUR 19.4M at the beginning of this year allows us to serenely envisage the financing of our important 2014 clinical program (three Phase II clinical studies on insulin, one Phase III clinical study in DFU), while also ensuring the active development of the DriveIn platform,” said Valerie Danaguezian, CFO.

Next events:

March 26, 2014: SFAF Meeting at the Euronext auditorium in Paris

April 7-8, 2014 : Adocia will attend the SmallCap Event in Paris

April 17, 2014 : Press release on the turnover for the 1st quarter of 2014

About Adocia:

To be a global leader for delivery of insulins and therapeutic proteins

Adocia is a biotech company specialized in the development of innovative formulations of already-approved therapeutic proteins with a strong expertise on insulins. The proprietary BioChaperone(R) technological platform is designed to enhance the effectiveness and safety of therapeutic proteins and their ease of use for patients.

Adocia successfully completed two Phases I and II studies on the formulation of a fast-acting human insulin, one Phase I of an ultra-fast acting insulin Lispro and one Phase I/II on a unique combination of Glargine, the gold-standard of basal insulin and fast-acting insulin analog, Lispro. The results of a new phase I/II clinical trial on ultra-fast acting lispro should be released by the second quarter of 2014.

Adocia has also obtained positive results on a Phase I/II on a diabetic foot ulcer healing product based on PDGF-BB.

Adocia has extended its activities to the formulation of monoclonal antibodies, which are gold standard molecules for the treatment of various chronic pathologies (oncology, inflammation, etc.). In this field, Adocia is engaged in collaborative programs with two major pharmaceutical companies.

To fight cancer by targeting oncology treatments

Adocia recently acquired the rights for the development and commercialization in healthcare of DriveIn, a nanotechnology which is remarkably efficient in carrying active molecules and delivering them into solid tumors. This new platform is an exceptional opportunity to enter the oncology market by improving the efficacy of already approved treatments and of proprietary molecules.

“Innovative medicine for everyone, everywhere”

Adocia’s therapeutic innovations aim at bringing solutions in a profoundly changing global pharmaceutical and economic context, characterized in particular by the increased prevalence and impact of the targeted pathologies, population growth and aging, the need to control public health expenditures and increasing demand from emerging countries.

Adocia is listed on the regulated market of Euronext in Paris (ISIN: FR0011184241, mnemo / Reuters / Bloomberg: ADOC, ADOC.PA, ADOC.FP) and its share included in the Next Biotech index.

For more information: http://www.adocia.com