Advanced Accelerator Applications Reports 15.4% Sales Growth in the Third Quarter of 2016 and Feedback from the FDA for Lutathera®, an Investigational Treatment for Neuroendocrine Tumors


Conference Call Today at 4:30 p.m. ET

Highlights:

  • Sales for the third quarter of 2016 increased 15.4% compared to the third quarter of 2015
  • Closed $150 million follow-on public offering and subsequent underwriters option to purchase additional $22.5 million
  • The U.S. Food and Drug Administration (FDA) issued feedback via a Discipline Review Letter on the New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
  • The European Medicines Agency (EMA) issued a positive opinion on the Marketing Authorization Application for SomaKit TOC®
  • Achieved marketing authorization in Switzerland for DOPAVIEW and AAACholine
  • Initiated two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin) in cardiovascular and cardio-oncology indications

SAINT-GENIS-POUILLY, France, Nov. 28, 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 financial results for the third quarter of 2016 and that the U.S. Food and Drug Administration (FDA) issued feedback on its New Drug Application (NDA) for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.

Third Quarter 2016 Financial Results

Total sales for the third quarter of 2016 were €26.72 million (USD(1) 30.03 million), a 15.4% year-on-year increase compared to €23.16 million (USD (1) 26.03 million) in the prior year period.

Operating loss for the third quarter of 2016 was €5.14 million (USD(1) 5.78 million), compared to a loss of €0.61 million (USD (1)  0.69 million) for the prior year period.

For the third quarter of 2016, the Company reported a net loss of €6.24 million (USD(1) 7.02 million), compared to €1.82 million (USD(1) 2.04 million) for the prior year period.

For the third quarter of 2016, adjusted EBITDA (see corresponding reconciliation exhibit below) was a loss of €1.73 million (USD(1) 1.95 million) compared to a profit of €2.13 million (USD (1) 2.4 million) for the prior year period.

In October, AAA closed a $150 million follow-on public offering of American Depositary Shares (“ADSs”) representing ordinary shares of the Company at a public offering price of $38.00 per ADS, before underwriting discounts and offering expenses. After the closing of the public offering, the underwriters exercised their option to purchase up to $22.5 million of additional ADSs at the public offering price, less the underwriting discount.

(1) Translated solely for convenience into USD at the noon buying rate of €1.00=1.1238 at September 30, 2016.

Lutathera® Update

Last week, the FDA issued feedback to the NDA for Lutathera® for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults. The FDA feedback identified issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which are precluding FDA reviewers from performing the required independent analysis of these clinical studies.

AAA will work closely with the FDA and the company’s Contract Research Organizations to resolve these issues and revise the data format to permit FDA review. AAA has concluded at this time that approval of Lutathera® is unlikely to occur by the PDUFA date of December 28, 2016. The FDA comments were provided via a Discipline Review Letter, which is a letter sent to an applicant to convey early thoughts on possible deficiencies of an application. The letter refers to reviews of the Clinical, Statistical, and Clinical Pharmacology sections of the submission. The FDA noted that their feedback does not reflect a final decision, is preliminary and subject to change.

Stefano Buono, Chief Executive Officer of AAA, commented, “Our belief in Lutathera’s potential to benefit patients remains steadfast. We are disappointed by the delay that we expect this development to cause in the FDA’s consideration of Lutathera’s NDA and are focused on addressing these issues as soon as possible. We are engaging additional resources to facilitate the delivery of datasets meeting the requirements outlined by the FDA.”

Buono continued, “To help address the needs of the U.S. NET patient community until this situation is resolved, we are planning to extend our Expanded Access Program (EAP). More than 30 patients across seven centers in the U.S. have received Lutathera® since the EAP’s initiation in July 2016, and several additional centers will become active before the end of the year. In addition, our medical team will be using this time to continue their work with NET centers and providers around the country to ensure that they have the infrastructure and processes necessary to properly manage the administration of a Peptide Receptor Radionuclide Therapy (PRRT).”

In September, AAA announced that the Accelerated Assessment timeline for the EMA’s review of the Marketing Authorization Application for Lutathera®, had been modified to a standard review period due to additional clarifications requested by the EMA, as well as their request to inspect one of AAA’s contract research organizations.

Additional Operational Updates

In October, AAA announced that the EMA issued a positive opinion on the Marketing Authorization Application for SomaKit TOC® 40 µg, a kit for radiopharmaceutical preparation of gallium Ga 68 edotreotide solution for injection, for PET imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastroenteropancreatic neuroendocrine tumors (GEPNET) for localizing primary tumors and their metastases.

In November, AAA announced that marketing authorization in Switzerland for two Positron Emission Tomography (PET) products, DOPAVIEW and AAACholine.

In September, AAA announced initiation of two Phase II clinical studies evaluating 99MTc-rhAnnexin V-128 (Annexin), a single-photon emission computed tomography (SPECT) diagnostic candidate for the assessment of apoptosis and necrosis, forms of cell death in cardiovascular and cardio-oncology indications.

Conference Call Information

Advanced Accelerator Applications management will host a conference call today at 4:30 p.m. ET. Interested parties may participate by dialing 877-407-8133 (US) or +1-201-689-8040 (International), approximately five minutes before the call start time. A live webcast of the conference call will be available at: http://www.investorcalendar.com/IC/CEPage.asp?ID=175484. A replay of the call will be available through December 28, 2016, at 11:59 p.m. ET. Interested parties may access the replay by dialing 877-481-4010 (US) or +1-919-882-2331 (International) and entering ID number 10163. An archived webcast of the conference call will be available for 90 days on the Investor Relations page of the Advanced Accelerator Applications website: www.adacap.com.

About Lutathera®

Lutathera® (or lutetium Lu 177 dotatate) is a Lu-177-labeled somatostatin analogue peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutathera® belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting neuroendocrine tumors with radiolabeled somatostatin analogue peptides. This novel compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Currently, Lutathera® is administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the US under an Expanded Access Program (EAP) for midgut NETs. In the analysis of the Lutathera® Phase III NETTER-1 trial’s primary endpoint of Progression Free Survival (PFS), the number of patients having disease progression or death was 23 in the Lutathera® arm and 68 in the Octreotide LAR 60 mg arm. The 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% of disease progression or death versus Octreotide LAR 60 mg (hazard ratio 0.21, 95% CI: 0.13-0.33; p<0.0001).  New Drug Application and Marketing Authorization Application submissions to the FDA and EMA are currently under review.
  
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 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 480 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, U.S. and Canada). AAA reported sales of €88.6 million in 2015 (+26.8% vs. 2014). 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. MNM can be divided in two branches: Molecular Nuclear Diagnostics and Molecular Nuclear Therapy. 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. Molecular nuclear therapy uses radioactive sources (radionuclides) to treat a range of tumor types. Using short-range particles, this therapy can target tumors with little effect on normal tissues.

Reconciliation of adjusted EBITDA to net loss for the year from continuing operations for the three and nine months ended September 30, 2016 and 2015

   Three months Three months Nine months
   September 30, 2016 September 30, 2016September 30, 2015 September 30, 2016September 30, 2015
   in USD thousands(1) In € thousands In € thousands
          
 Net loss for the period from continuing operations     (7,016)    (6,243)   (1,818)    (10,651)   (10,281)
          
 Adjustments        
 Finance income
(including changes in fair value of contingent consideration)
    (480)    (427)   (447)    (812)   (160)
 Finance costs
(including changes in fair value of contingent consideration)
    1,688     1,502    1,358     4,659    5,297 
 Income taxes    28     25    293     (422)   982 
 Depreciation and amortization    3,834     3,411    2,748     9,838    8,208 
          
 Adjusted EBITDA    (1,946)    (1,732)   2,134      2,612     4,046  
 Sales    30,031     26,723    23,164     81,282    66,138 
 Adjusted EBITDA margin  -6.48%  -6.48% 9.21%  3.21% 6.12%
          
 (1)Translated solely for convenience into dollars at the noon buying rate of EUR 1.00=USD 1.1238 at September 30, 2016. 

 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, including statements relating to PDUFA target action date, 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.


CONDENSED CONSOLIDATED STATEMENTS OF INCOME

THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015

         
         
  Three months Nine months  
 In € thousandsSeptember
30, 2016
September
30, 2015
 September
30, 2016
September
30, 2015
  
         
 Sales   26,723    23,164     81,282    66,138   
 Raw materials and consumables used   (6,072)   (4,827)    (17,268)   (13,918)  
 Personnel costs   (10,789)   (7,535)    (29,716)   (20,505)  
 Other operating expenses   (12,098)   (10,201)    (34,925)   (31,879)  
 Other operating income   504    1,533     3,239    4,210   
 Depreciation and amortization   (3,411)   (2,748)    (9,838)   (8,208)  
         
 Operating loss   (5,143)   (614)    (7,226)   (4,162)  
         
 Finance income
(including changes in fair value of contingent consideration)
   427    447     812    160   
 Finance costs
(including changes in fair value of contingent consideration)
   (1,502)   (1,358)    (4,659)   (5,297)  
         
 Net finance loss   (1,075)   (911)    (3,847)   (5,137)  
         
 Loss before income taxes   (6,218)   (1,525)    (11,073)   (9,299)  
         
 Income taxes   (25)   (293)    422    (982)  
         
 Loss for the period   (6,243)   (1,818)    (10,651)   (10,281)  
         
 Attributable to:        
 Owners of the company   (6,243)   (1,818)    (10,651)   (10,281)  
         
 Loss per share       
 Basic (€ per share)   (0.08)   (0.03)    (0.14)   (0.16)  
 Diluted (€ per share)   (0.08)   (0.03)    (0.14)   (0.16)  
         

 

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015

         
   Three months Nine months  
  In € thousandsSeptember
30, 2016
September
30, 2015
 September
30, 2016
September
30, 2015
  
  Loss for the period   (6,243)   (1,818)    (10,651)   (10,281)  
          
  Other comprehensive income / (expense):        
          
  Items that may be reclassified subsequently to profit or loss       
    Exchange differences on translating foreign operations   25    (1,714)    (374)   2,173   
          
  Items that will never be reclassified subsequently to profit or loss       
    Remeasurement of defined benefit liability   9    1     (34)   38   
          
  Other comprehensive income / (expense) net of tax (1)   34     (1,713)    (408)   2,211    
  Total comprehensive loss for the year   (6,209)   (3,531)    (11,059)   (8,070)  
          
  Total comprehensive loss attributable to:        
    Owner of the company   (6,209)   (3,531)    (11,059)   (8,070)  
          
  (1) Negative tax effect of €5 thousand at Q3 2016 and nil tax effect at Q3 2015.
Positive tax effect of €17 thousand for the nine months ended September 30, 2016 and negative tax effect of €19 thousand for the nine months ended September 30, 2015.
  
          

     

CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

AT SEPTEMBER 30, 2016

 ASSETS (in € thousands)September 30,
2016
December 31,
2015
  Non-current assets 149,524   116,872  
   Goodwill 33,487  22,662 
   Other intangible assets 45,010  31,884 
   Property, plant and equipment 62,463  56,332 
   Financial assets 1,404  1,512 
   Other non-current assets 6,523  4,185 
   Defered Tax assets 637  297 
  Current assets 119,640   157,231  
   Inventories 6,886  4,105 
   Trade and other receivables 29,366  23,625 
   Other current assets 10,511  10,615 
   Cash and cash equivalents 72,877  118,886 
 TOTAL ASSETS   269,164     274,103  
      
 EQUITY AND LIABILITIES (in € thousands)September 30,
2016
December 31,
2015
  Equity attributable to owners of the Company 162,915   169,754  
   Share capital 7,856  7,856 
   Share premium 213,982  213,982 
   Reserves and retained earnings (48,272) (35,083)
   Net loss for the period/year (10,651) (17,001)
  Total equity 162,915   169,754  
  Non-current liabilities 67,417   68,341  
   Non-current provisions 10,719  9,968 
   Non-current financial liabilities 13,403  16,205 
   Deferred tax liabilities 4,816  2,804 
   Other non-current liabilities 38,479  39,364 
  Current liabilities 38,832   36,008  
   Current provisions 1,018    -  
   Current financial liabilities 3,909  5,560 
   Trade and other payables 15,422  14,710 
   Other current liabilities 18,483  15,738 
  Total liabilities 106,249   104,349  
 TOTAL EQUITY AND LIABILITIES   269,164     274,103  
                      



CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015

     
  Nine months 
 In € thousandsSeptember 30,
2016
September 30,
2015
 
 Cash flows from operating activities   
 Net loss for the period (10,651) (10,281) 
     
 Adjustments:    
 Depreciation, amortization and impairment of non-current assets 9,838  8,208  
 Share based payment expense 4,220  1,145  
 Loss / (Gain) on disposal of property, plant and equipment 265  (3) 
 Financial result 3,847  5,137  
 Income tax expense (422) 982  
 Negative goodwill (127)   -   
  Subtotal 6,970   5,188   
     
 (Increase)/decrease in inventories (2,140) (994) 
 (Increase)/decrease in trade receivables (4,836) (7,236) 
 Increase/(decrease) in trade payables 1,900  247  
 Change in other receivables and payables (5,326) (937) 
 Increase / (decrease) in provisions 864  224  
 Change in working capital  (9,538 ) (8,697 ) 
     
 Income tax paid  (1,754) (1,138) 
 Net cash used in operating activities (4,322 ) (4,647 ) 
     
 Cash flows from investing activities   
 Acquisition of property, plant and equipment (10,234) (7,451) 
 Acquisition of intangible assets (1,241) (723) 
 Acquisition of financial assets (62) (70) 
 Reimbursement of financial assets 383  278  
 Interests received 389  230  
 Proceeds from disposal of property, plant and equipment 86  115  
 Proceeds from government grants 37    -   
 Acquisition of subsidiaries, net of cash acquired (22,453)   -   
 Net cash used in investing activities (33,095 ) (7,621 ) 
     
 Net cash from financing activities   
 Payment of deferred and contingent liabilities to former owners of acquired subsidiaries (2,878) (200) 
 Issuance of share capital   -   23,297  
 Repayment of borrowings  (4,397) (3,719) 
 Interests paid (405) (427) 
 Net cash (used) / generated in  financing activities (7,680 ) 18,951   
     
 Net (decrease) / increase in cash and cash equivalents (45,097 ) 6,683   
     
 Cash and cash equivalents at the beginning of the period 118,886  45,096  
 Effect of exchange rate changes on cash and cash equivalents (912) 506  
 Cash and cash equivalents at the end of the period 72,877   52,285   
     

            

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