- Solid cash position of EUR 58 million on December 31st, 2016
- Diabetes-focused portfolio featuring six promising programs, one phase 3-ready and two in advanced clinical development
- Continued development of BioChaperone® Lispro and search for a new partner following the termination of the partnership with Eli Lilly announced in January 2017
Lyon, France, March 07, 2017 - 6pm CET - ADOCIA (Euronext Paris: FR0011184241 – ADOC – the “Company”) announced today its financial results for 2016. The financial statements were approved by the board of directors on March 07, 2017 and will be submitted to the shareholders for approval at the next general shareholder’s meeting on June 27th, 2017.
“Following a number of positive clinical in 2016, Adocia faced the unexpected termination of the licensing deal with Eli Lilly on our key program BioChaperone Lispro in January 2017.” commented Gérard Soula, President and CEO of Adocia. “We are now actively looking for a new partner to execute Phase 3 clinical studies and commercialize our ultra-rapid insulin. We also have high hopes in the clinical advancement of BC Combo as well as in the potential of the products that are expected to enter clinical testing in 2017.”
A conference call will be held on Thursday, March 09, 2017 at 6 PM (CET)
Dial in number: (+33) 1 70 77 09 32
A replay of the conference will be available at the following number:
(+33) 1 72 00 15 01
REF: 307433#
A transcript in French and in English will be available on the website of the Company www.adocia.com
Financial Highlights
The consolidated financial statements on 31 December 2016 as well as detailed explanations on the evolution of accounts are presented in the attachment.
The results of the Company for 2016 are characterized by:
- A solid cash position of EUR 58 million, compared to EUR 72.1 million on December 31, 2015.
Over the full year 2016, the net amount of cash needed to finance operations amounted to EUR 14 million, compared to EUR 15.3 million over the same period in 2015.
Financial debts at the end of December 2016 totaled EUR 7 million. They consisted essentially of the loan contracted to finance the acquisition of the building in which the headquarters and the research center of the Company are located.
This acquisition is cash neutral for the Company, the reimbursement of the debts being equivalent to the payment of the previous rent.
- A net loss of EUR 7.9 million, compared to a positive net result of EUR 12.6 million in 2015, mainly constituted by:
- Revenue of EUR 22.5 million in 2016 (compared to EUR 37 million in 2015), which primarily results from the research and collaborative contract signed in December 2014 with Eli Lilly. In January 2017, Adocia announced Eli Lilly’s decision to terminate the collaboration. This decision will impact Adocia’s financial statements in 2017.
- Other operating income close to EUR 8 million, of which EUR 7.8 million in research and tax credit (“Crédit d’Impôt Recherche »), calculated on 2016 expenses.
- Operating expenses of EUR 38.5 million (compared to EUR 34.7 million in 2015) of which more than 80% are dedicated to research and development activities. The increase in expenses is mainly driven by an increase in staff expenditure reflecting the increase in the number of employees (from 93.9 Full Time Equivalent –FTEs- to 115.9 FTEs in 2016) and the impact of share-based compensation (non-cash item).
- A fiscal tax loss (by French standards) leading to the absence of tax.
“Our cash position of EUR 58 million on December 31st, 2016 allows us to continue the development of our projects as planned. We remain extremely watchful and strict to control our expenditures and we have set up the necessary actions to maintain a cash horizon over 2 years.” commented Valérie Danaguezian, Chief Financial Officer of Adocia. Key events in 2016:
- The advancement of the BioChaperone Lispro project under the partnership with Eli Lilly.
In 2016, Adocia and Eli Lilly announced positive results for four clinical studies:
- Repeated administration in people with type 1 diabetes: this study showed that BioChaperone Lispro U100 improves postprandial glycemic control compared to Humalog® U100 (insulin lispro, Eli Lilly) at the beginning and the end of a 14-day outpatient treatment period, during which each treatment was administered thrice a day in people with type 1 diabetes.
- Repeated administration in people with type 2 diabetes: a similar study confirmed these results for BioChaperone Lispro U100 vs. Humalog U100 after a 14- day outpatient treatment period in people with type 2 diabetes.
- Pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro in healthy Japanese subjects: this study confirmed the profile of BioChaperone Lispro in healthy Japanese subjects, which may allow to include Japanese people with diabetes in the global phase 3 program.
- Administration using insulin pumps in people with type 1 diabetes: this study confirmed the ultra-rapid profile of BioChaperone Lispro U100 compared to Humalog U100 in people with type 1 diabetes using insulin pumps.
To summarize, since the signing of the licensing and collaboration agreement in December 2014, Eli Lilly and Adocia have successfully completed 5 clinical studies with BioChaperone Lispro U100 and one pilot bioequivalence study of BioChaperone Lispro U100 / BioChaperone Lispro U200.
- A strengthened commitment to diabetes
2016 was the year of Adocia’s strategic decision to reinforce the commitment of the Company to the treatment of diabetes. This market is characterized by continuous growth and a very large population of patients, for whom there remains a significant medical need, both in terms of treatment efficacy and simplification of treatment regimen. Adocia addresses these patients’ needs by developing innovative and simple therapies, alone or in combination. These therapies aim to more closely mimic the healthy physiologic response while managing treatment costs.
In line with this strategy, in 2016, Adocia has pursued the development of its clinical programs as follows:
- BioChaperone Lispro, under the Eli Lilly-Adocia partnership, as described above.
- BioChaperone Combo, the unique combination of basal insulin glargine and prandial insulin lispro, with the initiation of a Phase 1/2 clinical study monitoring postprandial glycemic control (meal-test study) obtained in people with type 2 diabetes.
Results from this study are expected in the second quarter of 2017.
- BioChaperone human insulin (HinsBet): results from the Phase 1/2 meal-test clinical study published in April 2016 showed that HinsBet U100 profile translated into an improved postprandial glycemic control compared to human insulin (Humulin U100, Eli Lilly), and similar to that obtained with insulin lispro (Humalog U100, Eli Lilly) during the first hour after the meal.
The Company initiated two new preclinical programs in the diabetes field in 2016:
- BioChaperone Human Glucagon: this project aims to develop an aqueous formulation of human glucagon that could be used to rescue people experiencing severe hypoglycemia or in an artificial pancreas (i.e. an automated pump delivering both insulin and glucagon without any intervention from the patient). Based on promising formulation and preclinical results, Adocia expects to initiate a first-in-man study in 2017.
- BioChaperone Glargine GLP-1, 2-in-1 combinations of basal insulin glargine and GLP-1 receptor agonists: BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide. These projects aim to develop simple, 2-in-1 intensification options over basal insulin treatment, that could be both efficient and financially accessible. Based on promising formulation and preclinical results, Adocia expects to initiate a first-in-man study in 2017.
In line with the strategic focus on diabetes, Adocia terminated the mAbs (using Adocia technologies to improve formulation of third-parties proprietary monoclonal antibodies) and DriveIn® (nanoparticle-based drug delivery technology in oncology) programs, both at a preclinical stage.
Finally, 2016 was marked by the termination of the clinical development of BioChaperone PDGF-BB. In August 2016, Adocia announced that BioChaperone PDGF-BB did not meet the primary endpoint of the Phase 3 clinical study that had been performed in India to evaluate this product for the treatment of diabetic foot ulcer. Although these results were in contradiction with positive results previously obtained during a Phase 2 trial, and after initiating a thorough review of the data to explain this unexpected outcome, Adocia decided to terminate all development of BioChaperone PDGF-BB. Furthermore, following the agreement to sell signed in 2015, the Company became the owner of the building in which it has been established since its inception. This acquisition was financed by a bank loan.
Perspectives for 2017:
The beginning of 2017 was marked by Eli Lilly’s decision to terminate the license and collaboration agreement signed in December 2014 for the development of ultra-rapid formulations, BioChaperone Lispro. The contract will effectively come to an end after a 4 months period during which data and manufactured material will be transferred to Adocia. Adocia’s priority is now to find a new partner for the Phase 3 clinical development and the commercialization of this product.
Regarding BioChaperone Combo, Adocia is currently preparing a first dose-response study in people with type 1 diabetes. The Company also expects to launch a second outpatient repeated administration study in people with type 2 diabetes during the last quarter 2017.
Regarding HinsBet, Adocia’s strategy is to license the product to one or more regional partner(s) to allow its development and commercialization in emerging countries.
Regarding the new programs, the objective is to initiate first-in-man studies for BioChaperone Glucagon and one BioChaperone Glargine GLP-1 product before the end of the year.
Early in 2017, Adocia also announced the initiation of two new multi-hormonal combination projects for the treatment of type 1 diabetes:
- the combination of insulin lispro with pramlintide (amylin analog, Symlin®, AstraZeneca)
- the combination of insulin lispro with exenatide (GLP-1 receptor agonist, Byetta®, AstraZeneca).
These projects aim to offer people with type 1 diabetes alternative treatment options that more closely mimic the healthy physiologic response, without increasing the number of daily injections. These projects are currently in preclinical development. Adocia aims to initiate a first clinical study during the fourth quarter of 2017.
About Adocia
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins. Adocia’s portfolio of therapeutic proteins for the treatment of diabetes, featuring four clinical-stage products and six preclinical-stage products, 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 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 basal insulin glargine and rapid-acting insulin lispro (BioChaperone Combo). Adocia is also developing an aqueous formulation of human glucagon (BioChaperone Human Glucagon), two combinations of insulin glargine with GLP-1s (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide), two combinations of insulin lispro with synergistic prandial hormones (BioChaperone Lispro Pramlintide and BioChaperone Lispro Exenatide), and a concentrated, rapid-acting formulation of human insulin (HinsBet U500), all of which are in preclinical development.
Adocia aims to deliver “Innovative medicine for everyone, everywhere.”
To learn more about Adocia, please visit us at www.adocia.com
