Press Release. Adocia Reports Operational and Financial Results for the First Half of 2014

Transcription

1 Press Release Adcia Reprts Operatinal and Financial Results fr the First Half f 2014 Majr clinical results reprted n tw frmulatins based n insulin Sund financial psitin with apprximately EUR 16 millin in cash at June 30,2014 Lyn (France), July 24, Adcia (Eurnext Paris : FR ADOC), a bitechnlgy cmpany specialized in the develpment f best-in-class medicines frm already apprved therapeutic prteins, annunces tday its financial results fr the six mnths ended June 30, IFRS half year financial results fr the perid frm January 1 st t June 30 th 2014 have been submitted t a limited review by financial auditrs and validated by ur Bard Meeting held n July 23, The 2014 half year financial reprt is available n Adcia s website, Financials/Dcumentatin/Financial Reprt. Significant events f the first half f 2014: Annuncement f remarkable clinical results, first with the prduct BiChaperne Cmb, cmbinatin f basal insulin glargine and fast insulin Lispr and, secndly, with ultra-fast acting insulin BiChaperne Lispr. Cntinuatin f clinical develpment fr bth frmulatins: April 2014 marked the initiatin f a Phase II dse-effect study with the frmulatin BiChaperne Lispr. In additin, the Cmpany expects during the secnd semester t cmmence a Phase II dse-effect study with the BiChaperne Cmb, a cmbinatin f lng-acting insulin glargine and fast-acting insulin lispr. In July the Cmpany cmmenced a third insulin based prduct: BiChaperne human insulin (HinsBet ) as an alternative t insulin analgs fr prandial glycemic cntrl. Strengthening the prtfli f insulin frmulatins: Adcia is develping a furth prduct: a cncentrated frmulatin f insulin Lispr (Lispr BiChaperne U300) t treat patients using insulin pumps and fr patients with severe insulin resistance, which requires substantial dses f insulin. Increase f the visibility f the cmpany in the USA, thrugh the implementatin f an ADR prgram (American Depsit Receipt) and the presentatin f the successful clinical results at the American Diabete Assciatin Scientific sessins. 1

2 We are particularly pleased with the perfrmance f ur tw innvative frmulatins f insulin. The interest shwn by several large pharmaceutical cmpanies fr these tw prducts cnfirms ur strategic chices. Our next gal is t license these tw prjects, while actively pursuing their develpment stated Gérard Sula, President and CEO f Adcia. Financial highlights as f June 30, 2014: The fllwing table summarizes the half-year financial statements reprted in accrdance with IRFS standards fr the six-mnth perid ended June 30, 2014 cmpared with the sixmnth perid ended June 30, 2013: In thusand - IFRS Rules 30/06/ /06/2013 Operating revenue Research and develpment expenses (6 607) (6 460) General and administrative expenses (826) (926) Operating expenses (7 433) (7 386) Operating incme (lss) (5 559) (4 647) Financial net incme Net incme (lss) (5 545) (4 622) Average number f shares (in thusands) Net lss per share (in ) (0,9) (0,7) A sund financial psitin: With the receipt in June f EUR 3.2 millin granted under the French research and develpment tax credit (Crédit d Impôt Recherche) the Cmpany reprted cash and cash equivalents at June 30, 2014 f EUR 15.9 millin. The Cmpany s burnt rate was EUR 3.5 millin fr the first six mnths f An peratinal lss f EUR 5.5 millin fr the first half f 2014 cmpared with EUR 4.6 millin fr 2013 semester: - Operatinal expenses are relatively flat at EUR 7.4 millin cmpared with the same perid last year: The increase in the clinical expenses fr the first half f the year have been ffset by decreases in preclinical and subcntracting expenses; - Operatinal incme f EUR 1.9 millin represents a decrease f 32% cmpared with the same perid in 2013, reflecting the decrease f the revenue. On June 30, 2013, the licensing revenues recrded in the Prfit and Lss accunt resulted frm the agreement signed in 2011 with Eli Lilly and terminated in July We cntinue t develp ur prtfli f prducts while maintaining ur strict plicy f managing expenses stated Valérie Danaguezian, Chief Financial Officer. Our cash burnrate is in line with ur frecast and ur cash psitin at apprximately EUR16 millin allws us t cnfidently ensure the financing f ur peratinal plan. 2

3 Upcming events: Belw is a list f events Adcia plans t participate in thrugh the end f the year: - SFAF (French Sciety f Financial Analyst): Presentatin f first half financial results September 9 - Large & Midcap Event: Octber, 2 and 3; Paris. - EASD (Eurpean Assciatin fr the Study f Diabetes): September 15-19; Vienna, - PODD (Partnership Opprtunities in Drug Delivery): Octber 14-15; Bstn - BIO Eurpe: Nvember 3-5; Frankfurt, - BBC (Bstn Bitech Cnferences): Nvember 12-13; New Yrk. Abut Adcia T be a glbal leader in the innvative delivery f insulins and therapeutic prteins. Adcia is clinical-stage bitechnlgy cmpany that specializes in the develpment f innvative frmulatins f already-apprved therapeutic prteins. It has a particularly strng expertise in the field f insulins. Adcia s prprietary BiChaperne technlgical platfrm is designed t enhance the effectiveness and safety f therapeutic prteins and their ease f use fr patients. Adcia has successfully cmpleted tw Phase I and IIa studies f a fast-acting human insulin frmulatin (HinsBet), tw Phase I and IIa studies f an ultra-fast-acting insulin lispr (BiChaperne Lispr U100), a Phase I/II f a unique cmbinatin f insulin glargine, the gld-standard f basal insulin and insulin lispr, a fast-acting insulin analg (BiChaperne Cmb) and ne Phase II clinical study f its prduct based n PDGF-BB fr treating diabetic ft ulcer (BC PDGF-BB). A dse-escalatin Phase IIa study f BiChaperne Lispr U100 is nging. The German regulatry agency apprved In July 2014 the start f a Phase IIa clinical study fr HinsBet and a dse-escalatin Phase IIa study f BiChaperne Cmb is scheduled fr the furth quarter Finally, the cmpany is preparing a first clinical study f a new ultra-fast cncentrated insulin frmulatin based n insulin lispr (BiChaperne Lispr U300) fr Adcia has extended its activities t the frmulatin f mnclnal antibdies, which are gld-standard bilgics fr the treatment f varius chrnic pathlgies (cancer, inflammatin, etc.). Adcia is engaged in cllabrative prgrams with tw majr pharmaceutical cmpanies in this field. Fighting cancer with targeted treatments DriveIn is a nantechnlgy which is remarkably efficient in delivering active cmpunds int cancer cells. This new platfrm cnstitutes an exceptinal pprtunity t enter the nclgy market by imprving the efficacy f bth already apprved treatments and nvel prprietary mlecules. Innvative medicine fr everyne, everywhere Adcia s therapeutic innvatins aim at prviding slutins in a prfundly changing glbal pharmaceutical and ecnmic cntext, characterized by (i) an increased prevalence and impact f the targeted pathlgies, (ii) a grwing and ageing ppulatin, (iii) a need t cntrl public health expenditures and (iv) an increasing demand frm emerging cuntries. Adcia is listed n the regulated market f Eurnext Paris (ISIN: FR ; Reuters/Blmberg ticker: ADOC, ADOC.PA, ADOC.FP) and its share price is included in the Next Bitech index. American Depsitary Receipts representing Adcia cmmn stck are traded n the US OTC market under the ticker symbl ADOCY. Fr mre infrmatin: 3

4 Cntact Gerard Sula - Chairman and CEO Tel.: Relatins média ALIZE RP Carline Carmagnl - Sphie Clin Tel.: Disclaimer This press release cntains certain frward-lking statements cncerning Adcia and its business. Such frward-lking statements are based n assumptins that Adcia cnsiders t be reasnable. Hwever, there can be n assurance that the estimates cntained in such frward-lking statements will be verified, which estimates are subject t numerus risks including the risks set frth in the Risk Factrs sectin f the Reference Dcument registered by the Autrite des marches financiers n April 24, 2014 under number R (a cpy f which is available n hhtp:// and t the develpment f ecnmic cnditins, financial markets and the markets in which Adcia perates. The frward-lking statements cntained in this press release are als subject t risks nt yet knwn t Adcia r nt currently cnsidered material by Adcia. The ccurrence f all r part f such risks culd cause actual results, financial cnditins, perfrmance r achievements f Adcia t be materially different frm such frward-lking statements. This press release and the infrmatin cntained herein d nt cnstitute an ffer t sell r the slicitatin f an ffer t buy Adcia shares in any jurisdictin. 4

5 APPENDIX: Financial Results as f June 30, 2014: Operating revenues The fllwing table shws details f peratinal prducts fr each perid: In thusands IFRS rules 30/06/ /06/2013 Research and cllabrative agreements 186 (47) Incme frm licenses Revenue (a) Grants, public financing and research tax credits (b) Operating revenues (a)+(b) Operating revenues fr the first half f 2014 ended June 30 decreased by 32% cmpared with thse reprted during the same perid in Revenue ttaling EUR 0.2 millin as f June 30, 2014 is essentially resulting frm nging research and cllabrative cntracts related t the frmulatin f mnclnal antibdies. Fr the same perid, last year, revenue was EUR 0.9 millin due t the amrtizatin f the initial up-frnt payment received under the cntract signed with Eli Lilly in December 2011 and terminated in July The ther perating revenues prducts are mainly cnstituted by the tax credit research fr a ttal amunt f apprximately EUR 1.8 millin cmpared with apprximately EUR 1.9 millin as f June 30, They are n line with the level f the research and develpment expenses eligible ver the perid cncerned. Operating expenses 30/06/ /06/2013 In thusands IFRS rules Research and develpment expenses (6 607) (6 460) General and administrative expenses (826) (926) Operating Expenses (7 433) (7 386) 5

6 Operating expenses at EUR 7.4 millin recrded in the first half were flat cmpared with thse reprted last year. Nearly 89% f peratinal expenses are related t research and develpment expenses, and reflected the cntinuatin f strng R&D activities and tight cntrl f general and administrative and ther verhead activity. External expenses, which represent nearly 52% f the ttal perating expenses were flat cmpared with last year s same perid: the decrease in preclinical and subcntracting expenses was ffset by the increase in the clinical expenses (+ EUR 1.2 millin) and reflected the develpment and the maturity f Adcia s pipeline. Wages and salaries represent the secnd significant area f expenses and represented 40% f ttal perating expenses, cmpared with 39% f ttal perating expenses fr the first half f Balance sheet incme In thusands IFRS rules 30/06/ /12/2013 Cash and cash equivalents Ttal Assets Equity Financial debts As f June 30, 2014, cash and cash equivalents ttaled EUR 15.9 millin, cmpared with EUR 19.4 millin as f December 31, Sharehlder s equity decreased frm EUR 19 millin at the end f December 2013 t EUR 13.9 millin at the end f June 2014, mainly reflecting the lss reprted fr the first six mnths f Outstanding debt, amunting t EUR 2.4 millin at the end f June 2014, mainly advances received frm the French Agency fr innvatin (Osé) abut steprsis and insulin prjects. 6