Press Release Adcia: Activity and results fr the first half f 2013 Intensificatin f R&D activity ahead f the launch f three clinical trials fr insulin prjects, starting in the secnd half f 2013 Net result f EUR -4.6 millin as a result f step-up in R&D spending Sund financial psitin: EUR 22.8 millin in cash Lyn (France), September 5, 2013 - Adcia (NYSE Eurnext Paris: FR0011184241 - ADOC), a bitechnlgy cmpany specializing in the develpment f best-in-class medicines frm already apprved therapeutic prteins, annunces tday its financial results fr the first six mnths f 2013. IFRS half year financial results fr the perid frm January 1 st t June 30, 2013 have been submitted t a limited review by ur Financial auditrs and validated by ur Bard Meeting held n September 4, 2013 and authrized fr publicatin. The 2013 half year reprt is available n Adcia s website, in French nly, Investrs/Regulated Infrmatin/Financial reprt (http://www.adcia.cm/investrs,en,52.html). Significant events f the first half f 2013: Intensificatin f research activity in rder t gather clinical data fr the three planned clinical trials n type I diabetes patients. These trials are expected t take place during the secnd half f 2013 fr the insulin cmb, the fast-acting human insulin Hinsbet and the ultra fast-acting insulin analg prjects. A strengthened patent prtfli, with the apprval f three new patents in the USA. These include ne majr patent cvering BiChaperne prjects in clinical develpment, and the filing f tw new patents cvering innvatins in the field f insulin. A psitive scientific pinin frm the Eurpean Medicines Agency (EMA), cnfirming nly ne Eurpean phase III clinical trial fr the diabetic ft ulcer treatment wuld be required in rder t receive marketing authrizatin. In India, rerganizatin in the regulatry authrities structure has resulted in delays in the apprval f ur applicatin, meaning that authrizatin f ur phase III clinical trial is, at time f publicatin, still pending. 1
Pst June 2013 events: July 9, 2013: payment f EUR 3.1 millin granted under the French research and develpment tax credit (Crédit d Impôt Recherche) in respect t expenditure generated in 2012, bringing ur cash flw t EUR 23.5 millin at the end f August 2013. July 29, 2013: end f cllabratin with Eli Lilly fllwing a mutual decisin nt t cntinue further jint research as utlined in the December 2011 license agreement that granted Lilly access t Adcia s BiChaperne technlgy fr the frmulatin f a fast-acting insulin analg. Cnsequently, Adcia reacquired its exclusive develpment rights fr an ultra fast-acting insulin analg and intends t pursue this prject actively. This event will impact the third-quarter accunts that will benefit frm the upturn in revenue steaming frm the balance f the up-frnt payment (equal t EUR 4.6 millin in revenue with n cash impact). Befre year end, we intend t launch a phase II clinical trial fr the develpment f ur ultra fast-acting insulin analg, fllwing the terminatin f the Lilly partnership. We believe that this trial will increase the value f this prject, and cnsequently attract ptential cllabratins, said Gérard Sula, President and CEO f Adcia. Adcia is currently develping three cmplementary insulin therapy prducts and wns a wide and cherent prtfli f key prducts, likely t draw interest frm current actrs in the insulin field r frm new market players. Our strng financial psitin f EUR 23.5 millin enables us t finance ur prjects fr the next tw years. Financial highlights as f June 30, 2013: Sund financial psitin with EUR 22.8 millin in cash, with a burn rate f EUR 7.7 millin fr the first six mnths f the year. An peratinal lss f EUR 4.6 millin fr the first half cmpared with EUR 1.7 millin fr the six-mnth perid ending June 30, 2012. These results are in line with previsins made and reflect the investment in research and develpment carried ut in this first half. Operatinal expenses are therefre up EUR 1.5 millin (+26%) cmpared t the reprt fr the first six mnths fr the year 2012, while peratinal revenue has decreased cmpared t the first semester f 2012, which saw a EUR 1.4 millin payment arising frm research services. Our cash-flw is in line with ur peratinal plan, and ur pririty is t cntinue t manage it rigrusly, said Valérie Danaguezian, Chief Financial Officer f Adcia. Our slid financial situatin allws us t cntinue t develp ur prtfli f prducts, including the ultra fastacting insulin analg prject. Upcming events: - SFAF (French Sciety f Financial Analysts): Presentatin f first half financial results September 6, 2013 - Large & Midcap Event Octber 2 and 3, 2013 in Paris. 2
Financial Results as f June 30, 2013: The fllwing table summarizes the half-year financial statements established in accrdance with IRFS standards fr the six-mnth perid until June 30, 2013 and 2012. In thusands f Eurs IFRS Standards June 30, 2013 June 30, 2012 Operating Revenue 2 739 4 107 Research and develpment expenses (6 460) (5 094) General Expenses (926) (776) Operating Expenses (7 386) (5 870) Operatinal Results (lss) (4 647) (1 762) Net financial Incme 25 13 Net Result (lss) (4 622) (1 749) Average number f shares utstanding (in thusands) 6 203 5 739 Net lss per share (in ) (0.7) (0.3) 3
Operatinal Prducts: The fllwing table shws details f peratinal prducts fr each perid: In thusands f Eurs IFRS Standards 30/06/2013 30/06/2012 Research Cntracts and cllabrative develpment cntracts -47 1 398 Licenses Revenue 953 1 151 Turnver (a) 905 2 549 Grants, public funding and tax credit research (b) 1 834 1 558 Operating revenues (a)+(b) 2 739 4 107 Operating revenues n June 30, 2013 have decreased by 33% cmpared with thse registered ver the same perid in 2012. Licenses revenue amunts t nearly EUR 1 millin, in line with the six mnths f 2012. These revenues relate essentially t the amrtizatin f the up-frnt payment f EUR 7.6 millin received under the cntract signed with Eli Lilly fr the develpment f a new frmulatin f a fast acting insulin analg. Fr the first six mnths f 2013 n research cntract and cllabrative cntracts revenue has been registered due t the stage f current prjects and activities by Adcia. Fr the same perid in 2012, an amunt f EUR 1.4 millin has been recgnized. The ther perating revenues prducts are mainly cnstituted by the tax credit research fr a ttal amunt f EUR 1.8 millin cmpared with EUR 1.6 millin as f June 30, 2012. This increase is mainly explained by the increase f research and develpment expenses eligible ver the perid cncerned. 4
Operating expenses: In thusands f Eurs - IFRS June 30, 2013 June 30, 2012 Research and Develpment expenses (6 460) (5 094) General and administrative expenses (926) (776) Operating Expenses (7 386) (5 870) Operating expenses increased by 26%, r EUR +1.5 millin rising frm EUR 5.9 millin fr the first six mnths f 2012 t EUR 7.4 millin fr the first six mnths f 2013. Clse t 87% f peratinal expenses are accunted fr by research and develpment expenses. They reflect the increasing effrts made n the varius prjects in the prtfli. The main types f perating expenses are: External expenses represent mre than 53% in ttal peratinal expenses and are up +28% cmpared t the first six mnths f 2012. These expenses cnsist mainly f subcntracting csts relating t pre-clinical and clinical studies. Wage and salaries represent the secnd main area f expenses with mre than 38% f the ttal. The increase f 29% cmpared t the same perid f 2012 reflects new hires in 2012 t supprt the grwth f the cmpany and supprt its prjects. Balance sheet items In thusands f Eur IFRS Standards June 30, 2013 June 30, 2012 Cash and Cash equivalent 22 814 33 705 Ttal asset 30 378 40 308 Owner s equity Financial debts 18 852 2 086 27 325 2 442 5
As f June 30, 2013, the amunt f cash and cash equivalents held by the cmpany amunts t EUR 22.8 millin, cmpared with EUR 30.5 millin as f December 31, 2012. Sharehlder s equity has decreased frm EUR 23 millin at the end f December 2012 t EUR 18.8 millin at the end f June 2013, mainly reflecting capital increases due t the lss during the six first mnths f 2013. Financial debts, amunting t EUR 2.1 millin at the end f June 2013, mainly cncern the repayment f advances received frm the French Agency Osé innvatin. On the first half year, the cmpany reimbursed an amunt f EUR 0.4 millin fr the advance received fr the steprsis prject; this reimbursement was planned in the cntract signed in 2007. Abut Adcia Innvative medicine fr everyne, everywhere Adcia is a bitech cmpany specialized in the develpment f best-in-class drugs frm the innvative frmulatin f certain already-apprved therapeutic prteins. Adcia is specialized in insulin therapy and the treatment f the diabetic ft, ne f the main cmplicatins f diabetes. Wrldwide, mre than 366 millin individuals are currently suffering frm diabetes (with a frecast f 552 millin individuals by 2030, i.e. a 51% increase, reaching 70% in emerging cuntries). 15% f these patients will develp a ft ulcer during their lifetime. The markets targeted by Adcia represent mre than USD20 billin (USD17 billin fr insulin therapy and USD3 billin fr diabetic ft ulcer healing). Thrugh its BiChaperne state-f-the-art technlgical platfrm, Adcia intends t enhance the effectiveness and safety f therapeutic prteins and their ease f use fr patients, with the aim f making these medicines accessible t the bradest public. Adcia successfully cmpleted tw phases I and II studies n the frmulatin f a fast-acting human insulin and btained prmising phase I/II results n a diabetic ft ulcer-healing prduct. Furthermre, Adcia is develping a unique cmbinatin f fast-acting insulin and slw-acting insulin, fr an ptimal insulin therapy with ne single prduct. T be a glbal leader fr the frmulatin f therapeutic prteins Based n its experience and recgnized knw-hw, Adcia has extended its activities t the frmulatin f mnclnal antibdies, which are gld standard mlecules fr the treatment f numerus chrnic pathlgies (nclgy, inflammatin, etc.). In this field, Adcia is engaged in cllabrative prgrams with tw majr pharmaceutical cmpanies. Adcia s therapeutic innvatins aim at bringing slutins t a prfundly changing glbal pharmaceutical and ecnmic cntext, characterized in particular by the increased prevalence and impact f the targeted pathlgies, ppulatin grwth and ageing, the need t cntrl public health expenditures and increasing demand frm emerging cuntries. Adcia is listed n the regulated market f NYSE Eurnext in Paris (ISIN: FR0011184241, mnem / Reuters / Blmberg: ADOC, ADOC.PA, ADOC.FP) and its share included in the Next Bitech index. Fr mre infrmatin: www.adcia.cm Cntact Gérard Sula - cntactinvestisseurs@adcia.cm Chairman and CEO f Adcia Tél. : +33 4 72 610 610 Press Relatins Andrew Llyd & Assciates Sandra Régnavaque - Juliette ds Sants sandra@ala.cm - juliette@ala.cm Tel.: +33 1 56 54 07 00 Financial cmmunicatin & Investr Relatins NewCap Pierre Laurent Julien Perez plaurent@newcap.fr jperez@newcap.fr Tel.: +33 1 44 71 94 94 6
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 Autrité des marchés financiers n April 25, 2013 under number R13-017 (a cpy f which is available n www.adcia.cm) 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. 7