Market Overview

Advanced Accelerator Applications reports 26.8% sales growth in 2015 and continues to show significant clinical progress across both therapeutic and diagnostic platforms

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2015 Highlights

  • Reported a year-on-year increase in sales of 26.8% for the full-year and 14% for the fourth quarter of 2015.
  • Completed an IPO and listed on the Nasdaq Global Select Market under the ticker "AAAP"
  • Presented favorable results of pivotal Phase III trial, NETTER-1, for Lutathera for the treatment of neuroendocrine tumors
  • Received Fast Track designation from the FDA for Lutathera for the treatment of patients with inoperable, progressive, well-differentiated, Octreoscan-positive carcinoid tumors of the midgut
  • Submitted a New Drug Application (NDA) with the US Food and Drug Administration (FDA) for Ga-68 DOTATATE (Somakit-TATE) and was granted priority designation and submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Ga-68 DOTATOC (Somakit-TOC)
  • Enrolled the first patient in a Phase I/II clinical trial for its key diagnostic candidate Annexin V-128 in rheumatoid arthritis and ankylosing spondylitis.             

SAINT-GENIS-POUILLY, France, April 29, 2016 (GLOBE NEWSWIRE) -- Advanced Accelerator Applications S.A. (NASDAQ:AAAP) ("AAA" or "the Company"), an international specialist in Molecular Nuclear Medicine (MNM), today announced its fourth quarter and full year 2015 financial results.

Mr. Stefano Buono, AAA's CEO, commented, "2015 was a pivotal year for AAA. We continued our trend of significant sales growth, and the year was marked by the completion of two key milestones, namely: the completion of our IPO and simultaneous listing on the Nasdaq under the ticker "AAAP" and the announcement of favorable results from the pivotal Phase 3 NETTER-1 trial evaluating our lead therapeutic candidate, Lutathera. We also submitted an NDA and MAA in the U.S. and Europe, respectively, for Somakit, which could be the ideal in-vivo companion diagnostic for Lutathera."

Mr. Buono concluded, "In 2016, we have already achieved several key milestones to advance the company forward and support our future success. With our Lutathera filing now complete and submitted to the FDA and the EMA and the anticipated Somakit approval in both the US and Europe, we look forward to reporting our commercial developments gearing up towards the launch of both products."

Q4 and Full-Year 2015 Financial Results

Total sales for the Q4 2015 were €22.48 million (USD(1) 24.41 million), a 14% year-on-year increase compared to €19.7 million (USD(1) 21.4 million) in Q4 2014. For the year ended 31 December 2015 total sales were €88.6 million (USD(1) 96.2 million), a 26.8% year-on-year increase compared to €69.9 million (USD(1) 75.9 million) for the full year 2014.

Operating loss for the full year ended 31 December 2015 was €9.5 million (USD(1) 10.4 million), compared to a loss of €8.6 million (USD(1) 9.3 million) for the full year 2014.

For the year ended 31 December 2015, the Company reported a net loss of €17.0 million (USD(1) 18.5 million), compared to €10.8 million (USD(1) 11.7 million) for the full year 2014.

For the full year ended 31 December 2015, adjusted EBITDA (see corresponding reconciliation exhibit below) was €1.8 million (USD(1) 1.9 million), a 47% year-on-year decrease compared to €3.4 million (USD(1) 3.7 million) for the full year 2014.

(1) Translated solely for convenience into USD at the noon buying rate of €1.00=US$1.0859 at December 31, 2015.

Lutathera Update

The Lutathera Phase 3 study NETTER-1 trial showed a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death versus a treatment with a double dose of Octreotide LAR in patients with progressive midgut carcinoid tumors. The study demonstrated a favorable safety profile of the treatment, consistent with the experience that has been cumulated so far in academic institutions.

The NETTER-1 data was first presented in September 2015 at ESMO and further results were presented in more recent congresses such as ASCO GI, NANETS and ENETS.

Today AAA announced that the company had completed its rolling NDA submission to the FDA and that it had also recently submitted a Lutathera MAA to the EMA. In these filings AAA has asked for Priority Review from the FDA and Accelerated Assessment from the EMA. Accelerated Assessment from the EMA has recently been granted.

Conference Call

At 11:00 a.m. Eastern Time today, AAA's management will host a conference call and a simultaneous webcast to discuss results from its full year 2015 as well as provide 2016 guidance and a general business update. To access the webcast live via the internet, please connect to the company's website at www.adacap.com 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call 1-877-751-5015 (U.S.) or 1-615-247-0178 (international) and dial the audience passcode 96896214 to access the call.

A replay of the webcast will be archived on the company's website for one year.

About Lutathera and NETTER-1

Lutathera (or 177Lu-DOTATATE) is a Lu-177-labeled somatostatin analogue peptide currently under development for the treatment of gastro entero pancreatic neuroendocrine tumors (GEP-NETs). This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Lutathera was also granted fast-track designation by the FDA in April 2015 for the treatment of inoperable progressive midgut NETs. The FDA provides fast-track designation to product candidates that treat serious conditions and fill an unmet medical need in order to facilitate their development and expedite their review. Lutathera is also currently administered on a compassionate use and named patient basis for the treatment of NETs in ten European countries and in the US under an Expanded Access Program (EAP).

Lutathera belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy ("PRRT"), which involves targeting carcinoid tumors with radiolabeled somatostatin analogue peptides. Currently at the end of its Phase III development in its pivotal NETTER-1 study, Lutathera is the most advanced candidate in development for PRRT.

Lutathera's NETTER-1 study is the first Phase 3 international, multi-center, randomized, controlled trial evaluating 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) in patients with inoperable, progressive, somatostatin receptor positive midgut NETs. 230 patients with Grade 1-2 metastatic midgut NETs (both functioning and not functioning) were randomized to receive Lutathera 7.4 GBq every 8 weeks (x4 administrations) versus Octreotide LAR 60 mg every 4-weeks. The primary endpoint was PFS per RECIST 1.1 criteria, with objective tumor assessment performed by an independent reading center every 12 weeks. Secondary objectives included objective response rate, overall survival, safety, and health-related quality of life.

The Phase 3 NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death versus a treatment with a double dose of Octreotide LAR  (hazard ratio 0.21, 95% CI: 0.13-0.33; p<0.0001). The median PFS in the Lutathera arm is not yet reached, whilst the median PFS in the Octreotide LAR 60 mg arm was 8.4 months.

Complete and partial responses (CR+PR) were reported in 18 patients (18%) in the Lutathera group versus 3 (3%) in the Octreotide LAR 60 mg group (p=0.0008). Although the overall survival (OS) data is not mature enough for a definitive analysis, the number of deaths was 14 in the Lutathera group and 26 in the Octreotide LAR 60 mg group  (p=0.0043 at interim analysis), which suggests an improvement in OS. Only 5% of the patients (6 patients) experienced Lutathera dose modifying toxicity. Adverse events grade 3 or 4 neutropenia, thrombocytopenia and lymphopenia occurred in 1%, 2% and 9% of the patients in Lutathera arm vs. none in the control group.

The Phase 3 NETTER-1 study provides evidence of a clinically meaningful and statistically significant increase in PFS and objective response rate ("ORR"), and also suggests a survival benefit in patients with advanced midgut neuroendocrine tumors treated with Lutathera.

The adverse events observed for Lutathera in the NETTER-1 study were consistent with the results of Lutathera's previous Phase I-II study, with Lutathera demonstrating a favorable safety profile.

About Advanced Accelerator Applications

Advanced Accelerator Applications (AAA) is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine (MNM) products. AAA's lead therapeutic product candidate, Lutathera, is a novel MNM compound that AAA is currently developing for the treatment of Neuro Endocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 18 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 440 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA is listed on the Nasdaq Global Select Market under the ticker "AAAP". For more information please visit: www.adacap.com

About Molecular Nuclear Medicine ("MNM")

Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions and to treat various diseases, like cancer. The technique works by injecting targeted radiopharmaceuticals into the patient's body that accumulate in the organs or lesions and reveal specific biochemical processes. Molecular Nuclear Diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages.

Reconciliation of adjusted EBITDA to net income (loss) for the year from continuing operations

      
 Year Ended December 31,
  2015
  2014    2013    2012  
 US$(1)EuroEuroEuro 
 (US Dollars and Euros in thousands)
      
Net profit/(loss) for the period  (18,461)   (17,001)   (10,803)   (12,781)   (20,504) 
Adjustments:     
Finance income  (1,255)   (1,156)   (396)   (387)   (232) 
(including changes in fair value of contingent consideration)     
Finance costs                         
(including changes in fair value of contingent consideration)   8,526     7,852    2,196    10,155     16,512  
Income taxes  837    771    404    1,157    536  
Depreciation and amortization  12,294    11,321    11,993    9,545    6,495  
Adjusted EBITDA  1,941    1,787    3,394    7,689    2,807  
Sales  96,227    88,615    69,865    53,806    40,834  
Adjusted EBITDA margin   2.0 %   2.0   4.9   14.3   6.9 
_________________
(1) Translated solely for convenience into dollars at the noon buying rate of €1.00=US$1.0859 at December 31, 2015.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for Lutathera and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of Lutathera and our other products or product candidates; our estimates regarding the market opportunity for Lutathera, our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

CONSOLIDATED STATEMENTS OF INCOME

FOR THE YEARS ENDED DECEMBER 31, 2015, 2014 AND 2013

In € thousands  12.31.2015  12.31.2014  12.31.2013  
     
Sales    88,615    69,865    53,806 
Raw materials and consumables used    (18,335)   (14,597)   (9,185)
Personnel costs    (29,520)   (21,089)   (16,265)
Other operating expenses    (44,447)   (35,015)   (24,644)
Other operating income    5,474    4,230    3,977 
Depreciation and amortization    (11,321)   (11,993)   (9,545)
     
Operating loss    (9,534)   (8,599)   (1,856)
     
Finance income (including changes in fair value of contingent consideration)    1,156    396    387 
Finance costs (including changes in fair value of contingent consideration)    (7,852)   (2,196)   (10,155)
     
Net finance loss    (6,696)   (1,800)   (9,768)
     
Loss before income taxes    (16,230)   (10,399)   (11,624)
     
Income taxes    (771)   (404)   (1,157)
     
Loss for the year    (17,001)   (10,803)   (12,781)
     
Attributable to:     
Owners of the Company    (17,001)   (9,499)   (12,152)
Non-controlling interests    -      (1,304)   (629)
     
Loss per share    
     
Basic (€ per share)    (0.25)   (0.15)   (0.22)
Diluted (€ per share)    (0.25)   (0.15)   (0.22)
     


CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

YEAR ENDED DECEMBER 31, 2015, 2014 AND 2013

In € thousands  12.31.2015  12.31.2014   12.31.2013  
Loss for the year    (17,001)   (10,803)   (12,781)
     
Other comprehensive income / (expense):     
     
Items that may be reclassified subsequently to profit or loss    
  Exchange differences on translating foreign operations  3,239    2,053    (125)
     
Items that will never be reclassified subsequently to profit or loss    
  Remeasurement of defined benefit liability    (559)   (61)   17 
     
Other comprehensive income / (expense) net of tax (1)  2,680    1,992    (108)
Total comprehensive loss for the year  (14,321

)
 (8,811) (12,889)
     
Total comprehensive loss attributable to:     
  Owners of the Company    (14,321)   (7,776)   (12,061)
  Non-controlling interests    -    (1,035)   (828)

(1) Tax effect of € 176 thousand at December 31, 2015, € 31 thousand at December 31, 2014 and € (5) thousand at December 31, 2013.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

AT DECEMBER 31, 2015, 2014 AND 2013

ASSETS (In € thousands)  12.31.2015  12.31.2014   12.31.2013  
Non-current assets    112,687     107,842     103,449  
Goodwill    22,662    21,377    21,252 
Other intangible assets    31,884    32,410    30,581 
Property, plant and equipment    56,332    51,779    49,280 
Financial assets    1,512    1,959    2,336 
Deferred tax assets    297    317    - 
Current assets    161,416     78,672     40,028  
Inventories    4,105    3,363    2,278 
Trade and other receivables    23,625    20,053    16,143 
Other current assets    14,800    10,160    7,997 
Cash and cash equivalents    118,886    45,096    13,610 
TOTAL ASSETS    274,103     186,514     143,477  
     
EQUITY AND LIABILITIES (In € thousands)  12.31.2015  12.31.2014   12.31.2013  
Equity attributable to owners of the Company    169,754     85,187     55,723  
Share capital    7,856    6,323    5,415 
Share premium    213,982    118,421    76,594 
Reserves and retained earnings    (35,083)   (30,058)   (14,134)
Net loss for the year    (17,001)   (9,499)   (12,152)
Non-controlling interests    -      -      1,360  
Total equity    169,754     85,187     57,083  
Non-current liabilities    68,341     70,709     62,052  
Non-current provisions    9,968    8,011    6,029 
Non-current financial liabilities    16,205    20,971    20,359 
Deferred tax liabilities    2,804    4,460    4,187 
Other non-current liabilities    39,364    37,267    31,477 
Current liabilities    36,008     30,618     24,342  
Current provisions    -     128    115 
Current financial liabilities    5,560    5,915    5,458 
Trade and other payables    14,710    12,156    9,218 
Other current liabilities    15,738    12,419    9,551 
Total liabilities    104,349     101,327     86,394  
TOTAL EQUITY AND LIABILITIES    274,103     186,514     143,477  


CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

YEAR ENDED DECEMBER 31, 2015

 Attributable to the Company 
In € thousandsShare capitalShare premiumTranslation reserveNet Income / (loss)  for the yearGroup reservesTotal
       
At January 1, 2015  6,323   118,421   1,620   (9,499)  (31,678)  85,187
       
Comprehensive income for the year      
Loss for the year  -   -   -   (17,001)  -   (17,001)
Other comprehensive income / (loss) for the year  -   -   3,239  -   (559)  2,680
Total comprehensive income  -    -    3,239   (17,001)  (559)  (14,321)
       
Transactions with owners of the Company      
Issue of ordinary shares  1,533  102,209  -   -   -   103,742
Share issue costs  -   (6,648)  -   -   -   (6,648)
Appropriation of 2014 net loss  -   -   -   9,499  (9,499)  - 
Equity-settled share-based payments  -   -   -   -   1,794  1,794
Total transactions with owners of the Company  1,533   95,561   -    9,499   (7,705)  98,888
At December 31, 2015  7,856   213,982   4,859   (17,001)  (39,942)  169,754



CONSOLIDATED STATEMENTS OF CASH FLOWS

YEARS ENDED DECEMBER 31, 2015, 2014 AND 2013

In € thousands 12.31.2015  12.31.2014   12.31.2013  
    
Cash flows from operating activities   
Net loss for the year   (17,001)   (10,803)   (12,781)
Adjustments:    
Depreciation, amortization and impairment of non-current assets   11,321    11,993    9,545 
Share based payment expense   1,794    2,278    2,281 
Loss / (Gain) on disposal of property, plant and equipment   367    10    (62)
Financial result   6,696    1,800    9,768 
Income tax expense   771    404    1,158 
Negative Goodwill recognized in other operating income   -    94    -  
Subtotal   3,948     5,776     9,909  
    
Increase in inventories   (742)   (1,085)   (445)
Increase in trade receivables   (3,572)   (3,910)   (606)
Increase / (decrease) in trade payables   156    2,938    (639)
Change in other receivables and payables   (1,436)   (58)   (442)
Increase in provisions   752    153    253 
Change in working capital    (4,842)   (1,962)   (1,879)
    
Income tax paid   (2,902)   (1,451)   (663)
Net cash used in operating activities   (3,796)   2,363     7,367  
Cash flows from investing activities   
Acquisition of property, plant and equipment   (11,286)   (8,860)   (9,289)
Acquisition of intangible assets   (910)   (394)   (634)
Acquisition of financial assets   (99)   (745)   (116)
Interest received   200  265  379 
Repayment on financial assets   278     1,122    -  
Proceeds from disposal of property, plant and equipment   118    113    130 
Proceeds from government grants   -     623    -  
Acquisition of subsidiaries, net of cash acquired   -     (561)   (1,395)
Net cash used in investing activities   (11,699)   (8,437)   (10,925)
Net cash from financing activities   
Payment of deferred and contingent liabilities to former owners of acquired subsidiaries   (1,494)   (1,884)   -  
Issuance of share capital   97,094    40,666    4,820 
Transactions with shareholders   -     (1,464)   -  
Proceeds from borrowings   210    8,041    3,496 
Repayment of borrowings   (4,852)   (7,016)   (4,058)
Interests paid   (827)   (906)   (1,029)
Net cash from financing activities   90,131     37,437     3,229  
    
Net increase / (decrease) in cash and cash equivalents   74,636    31,363     (329)
    
Cash and cash equivalents at the beginning of the year   45,096    13,611    13,947 
Effect of exchange rate changes on cash and cash equivalents   (846)   122    (7)
Cash and cash equivalents at the end of the year    118,886     45,096     13,611  
Contacts AAA Media Relations Laetitia Defaye Head of Corporate Communications laetitia.defaye@adacap.com Tel: +33 (0)6 86 65 73 52 Véronique Mermet Communications Officer veronique.mermet@adacap.com Tel: +33 (0)4 50 99 30 70 AAA Investor Relations Jordan Silverstein Director of Investor Relations jordan.silverstein@adacap.com Tel: + 1-212-235-2394 Media enquiries FTI Consulting Shauna Elkin shauna.elkin@fticonsulting.com Tel: +1-212-850-5613 Axess Public Relations (Italy) Dario Francolino dario.francolino@axesspr.com Tel: +39 3488818029

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