Company completes enrollment in Lutathera Phase III trial with pivotal data expected in 2015
09 April 2015, Saint-Genis-Pouilly, France - Advanced Accelerator Applications S.A. (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced its Q4 and full year 2014 financial results.
2014 Highlights
• Reported an increase in year-on-year sales of 29.8% for the full-year and 32% for Q4 2014 compared to Q4 2013
• Completed enrollment of pivotal Phase III trial, NETTER-1, for Lutathera for the treatment of neuroendocrine tumors
• Received orphan drug designation from FDA and EMA for Ga-68 DOTATATE (Somakit) for use in patients with gastroenteropancreatic neuroendocrine tumors
• Continued to grow the business through the successful completion of several acquisitions and further enhanced the Company’s R&D and operational capabilities
• Expanded into the U.S. for the planned development of both U.S. sales headquarters and Lutathera manufacturing facility for servicing all of North America
Mr. Stefano Buono, AAA’s CEO, commented, “2014 was a very successful year for AAA. We continued our trend of significant revenue growth, while also completing enrollment of our Phase III clinical trial for therapeutic candidate Lutathera. We anticipate presenting topline data in the second half of 2015 and expect to file both a New Drug Application (NDA) with the U.S. FDA and a Marketing Authorization Application (MAA) with the EMA within 2016. Another achievement was gaining orphan drug designation in the U.S. and Europe for Somakit, which will be used as a companion diagnostic for Lutathera. We plan to file an NDA and MAA for this product by the end of 2015.”
Mr. Buono concluded, “Looking ahead, with a significantly strengthened balance sheet following a successful capital raise in February 2014, and having both consolidated and diversified our revenue stream through strategic acquisitions, we are well positioned to further develop and expand our pipeline of radiopharmaceuticals.”
Q4 and Full Year 2014 Financial Results
Total sales for Q4 2014 were €19.7 million (USD(1) 24.6 million), a 32.2% year-on-year increase compared to €14.9 million (USD(1) 18.6 million) in Q4 2013. For the year ended 31 December 2014 total sales were €69.9 million (USD(1) 92.9 million), a 29.8% year-on-year increase compared to €53.8 million (USD(1) 71.5 million) for the year 2013.
For the quarter ending 31 December 2014, operating loss was €7.3 million (USD(1) 9.1 million), compared to €2.7 million (USD(1) 3.4 million) for Q4 2013. Operating loss for the full year ended 31 December 2014 was €8.6 million (USD(1) 11.4 million), an increase of 352% year-on-year compared to €1.9 million (USD(1) 2.5 million) for the full year 2013.
Net loss for Q4 2014 was €8.4 million (USD(1) 10.4 million), a 16.8% year-on-year decrease compared to €10.1 million (USD(1) 12.6 million) for the comparable period of 2013. For the year ended 31 December 2014, the Company reported a net loss of €10.8 million (USD(1) 14.4 million), a 15.5% year-on-year decrease compared to €12.8 million (USD(1) 17 million) for the full year 2013. The losses in 2014 are essentially explained by a combination of R&D expenses, the hiring of personnel in the U.S., Germany and Poland and the costs related to a postponed IPO. The losses in 2013 are due to R&D expenses and the variation of contingent liabilities related to acquisitions.
Adjusted EBITDA for the quarter ended 31 December 2014 was €-2.6 million (USD(1) -3.2 million) compared to €1.4 million (USD(1) 1.7 million) for Q4 2013. For the full year 2014 adjusted EBITDA* was €3.4million (USD(1) 4.5 million), a 56% year-on-year decrease compared to €7.7 million (USD(1) 10.2 million) for the full year 2013. This decrease is mainly due to the IPO related charges accounted for in Q4 2014, this includes legal costs.
(1) Translated solely for convenience into USD. Applied for income statement of full years 2014 and 2013 is an exchange rate of €1 = USD 1.329 (average for the year 2014), for Q4/2014 and Q4/2013 the applied exchange rate is 1€=1.249 (average for Q4/2014).
2014 Acquisitions
On 14 February 2014, AAA entered into an agreement to acquire 100% of the shares of Imaging Equipment Ltd (IEL), a privately-owned distributor of nuclear medicine products, based in England, which enabled entry into UK and Irish nuclear medicine markets.
On 15 September 2014, AAA acquired the FDG-PET business of GE Healthcare S.r.L. This acquisition includes the SteriPET® (FDG) Marketing License and consists of certain assets, liabilities and legal relationships, primarily customer relationships, which strengthen the Company’s commercial operations in Italy.
On 10 November 2014, the Company acquired the remaining 49.9% non-controlling interest in AAA Germany GmbH (the former Umbra AG). As a result of this acquisition, AAA now owns 100% of AAA Germany GmbH.
On 18 December 2014, the Company acquired the remaining 49.9% non-controlling interest in Atreus Pharmaceuticals Corporation (Atreus). As a result of this acquisition, AAA now has 100% ownership of Atreus, which facilitates R&D work and, if the Company is successful in obtaining marketing authorization for Annexin, would support a more effective exploitation of the commercial potential of the product.
-----
About NETTER-1
NETTER-1 is an international, multi-center, randomized, Phase III study comparing treatment with Lutathera to a double dose of Octreotide LAR in patients with inoperable, progressive under Octreotide LAR treatment, midgut carcinoids (neuroendocrine tumors of the midgut) overexpressing somatostatin receptors. The primary endpoint of the trial is the assessment of progression-free survival (PFS). Secondary endpoints include safety, objective response rate, time to tumor progression, overall survival and quality of life. The study is being conducted in 51 clinical centers in the United States and Europe and has completed enrollment in February 2015. At the end of March 2015 the study reported 63 primary events of progression out of the 74 expected to meet the primary endpoint and close the study. Lutathera is aiming at covering an unmet medical need, as after progression from “cold” analogues of somatostatin such as Octreotide LAR, there are no alternative therapies approved in this indication.
About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA’s main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions (“Personalized Medicine”). AAA currently has 17 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 340 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2014 AAA reported sales of €69.9 million (+29.8% vs. 2013). 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.
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
info@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 (UK)
Julia Phillips
Julia.Phillips@fticonsulting.com
Tel: +44 (0)203 727 1000
Natalie Garland-Collins
Natalie.Garland-Collins@fticonsulting.com
Tel: +44 (0)203 727 1000
iCorporate (Italy)
Elisa Piacentino
elisa.piacentino@icorporate.it
Tel: +39 02 4678754 - +39 366 9134595
Federica Casilli
federica.casilli@icorporate.com
Tel: +39 02 4678756
JV Public Relations NY (US)
Janet Vasquez
jvasquez@jvprny.com
Tel: + 1-212- 645-5498 - +1-917- 569-7470'
For full access, please click here.
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09 April 2015, Saint-Genis-Pouilly, France - Advanced Accelerator Applications S.A. (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), today announced its Q4 and full year 2014 financial results.
2014 Highlights
• Reported an increase in year-on-year sales of 29.8% for the full-year and 32% for Q4 2014 compared to Q4 2013
• Completed enrollment of pivotal Phase III trial, NETTER-1, for Lutathera for the treatment of neuroendocrine tumors
• Received orphan drug designation from FDA and EMA for Ga-68 DOTATATE (Somakit) for use in patients with gastroenteropancreatic neuroendocrine tumors
• Continued to grow the business through the successful completion of several acquisitions and further enhanced the Company’s R&D and operational capabilities
• Expanded into the U.S. for the planned development of both U.S. sales headquarters and Lutathera manufacturing facility for servicing all of North America
Mr. Stefano Buono, AAA’s CEO, commented, “2014 was a very successful year for AAA. We continued our trend of significant revenue growth, while also completing enrollment of our Phase III clinical trial for therapeutic candidate Lutathera. We anticipate presenting topline data in the second half of 2015 and expect to file both a New Drug Application (NDA) with the U.S. FDA and a Marketing Authorization Application (MAA) with the EMA within 2016. Another achievement was gaining orphan drug designation in the U.S. and Europe for Somakit, which will be used as a companion diagnostic for Lutathera. We plan to file an NDA and MAA for this product by the end of 2015.”
Mr. Buono concluded, “Looking ahead, with a significantly strengthened balance sheet following a successful capital raise in February 2014, and having both consolidated and diversified our revenue stream through strategic acquisitions, we are well positioned to further develop and expand our pipeline of radiopharmaceuticals.”
Q4 and Full Year 2014 Financial Results
Total sales for Q4 2014 were €19.7 million (USD(1) 24.6 million), a 32.2% year-on-year increase compared to €14.9 million (USD(1) 18.6 million) in Q4 2013. For the year ended 31 December 2014 total sales were €69.9 million (USD(1) 92.9 million), a 29.8% year-on-year increase compared to €53.8 million (USD(1) 71.5 million) for the year 2013.
For the quarter ending 31 December 2014, operating loss was €7.3 million (USD(1) 9.1 million), compared to €2.7 million (USD(1) 3.4 million) for Q4 2013. Operating loss for the full year ended 31 December 2014 was €8.6 million (USD(1) 11.4 million), an increase of 352% year-on-year compared to €1.9 million (USD(1) 2.5 million) for the full year 2013.
Net loss for Q4 2014 was €8.4 million (USD(1) 10.4 million), a 16.8% year-on-year decrease compared to €10.1 million (USD(1) 12.6 million) for the comparable period of 2013. For the year ended 31 December 2014, the Company reported a net loss of €10.8 million (USD(1) 14.4 million), a 15.5% year-on-year decrease compared to €12.8 million (USD(1) 17 million) for the full year 2013. The losses in 2014 are essentially explained by a combination of R&D expenses, the hiring of personnel in the U.S., Germany and Poland and the costs related to a postponed IPO. The losses in 2013 are due to R&D expenses and the variation of contingent liabilities related to acquisitions.
Adjusted EBITDA for the quarter ended 31 December 2014 was €-2.6 million (USD(1) -3.2 million) compared to €1.4 million (USD(1) 1.7 million) for Q4 2013. For the full year 2014 adjusted EBITDA* was €3.4million (USD(1) 4.5 million), a 56% year-on-year decrease compared to €7.7 million (USD(1) 10.2 million) for the full year 2013. This decrease is mainly due to the IPO related charges accounted for in Q4 2014, this includes legal costs.
(1) Translated solely for convenience into USD. Applied for income statement of full years 2014 and 2013 is an exchange rate of €1 = USD 1.329 (average for the year 2014), for Q4/2014 and Q4/2013 the applied exchange rate is 1€=1.249 (average for Q4/2014).
2014 Acquisitions
On 14 February 2014, AAA entered into an agreement to acquire 100% of the shares of Imaging Equipment Ltd (IEL), a privately-owned distributor of nuclear medicine products, based in England, which enabled entry into UK and Irish nuclear medicine markets.
On 15 September 2014, AAA acquired the FDG-PET business of GE Healthcare S.r.L. This acquisition includes the SteriPET® (FDG) Marketing License and consists of certain assets, liabilities and legal relationships, primarily customer relationships, which strengthen the Company’s commercial operations in Italy.
On 10 November 2014, the Company acquired the remaining 49.9% non-controlling interest in AAA Germany GmbH (the former Umbra AG). As a result of this acquisition, AAA now owns 100% of AAA Germany GmbH.
On 18 December 2014, the Company acquired the remaining 49.9% non-controlling interest in Atreus Pharmaceuticals Corporation (Atreus). As a result of this acquisition, AAA now has 100% ownership of Atreus, which facilitates R&D work and, if the Company is successful in obtaining marketing authorization for Annexin, would support a more effective exploitation of the commercial potential of the product.
-----
About NETTER-1
NETTER-1 is an international, multi-center, randomized, Phase III study comparing treatment with Lutathera to a double dose of Octreotide LAR in patients with inoperable, progressive under Octreotide LAR treatment, midgut carcinoids (neuroendocrine tumors of the midgut) overexpressing somatostatin receptors. The primary endpoint of the trial is the assessment of progression-free survival (PFS). Secondary endpoints include safety, objective response rate, time to tumor progression, overall survival and quality of life. The study is being conducted in 51 clinical centers in the United States and Europe and has completed enrollment in February 2015. At the end of March 2015 the study reported 63 primary events of progression out of the 74 expected to meet the primary endpoint and close the study. Lutathera is aiming at covering an unmet medical need, as after progression from “cold” analogues of somatostatin such as Octreotide LAR, there are no alternative therapies approved in this indication.
About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA’s main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions (“Personalized Medicine”). AAA currently has 17 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 340 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2014 AAA reported sales of €69.9 million (+29.8% vs. 2013). 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 EBITDA to net income (loss) for the year from continuing operations
|
In thousands of Euros |
12.31.2014 |
12.31.2013 |
|
|
(10,803) |
(12,781) |
|
Adjustments: |
|
|
|
Income taxes………........................................................................... |
404 |
1,157 |
|
Finance costs (incl. changes in fair value of contingent consideration)…... |
2,196 |
10,155 |
|
Finance income (incl. changes in fair value of contingent consideration)…. |
(396) |
(387) |
|
Depreciation and amortization……………......................................... |
11,993 |
9,545 |
|
Adjusted EBITDA…………............................................................... |
3,394 |
7,690 |
|
Sales………....................................................................................... |
69,865 |
53,806 |
|
Adjusted EBITDA margin……………………………………………… |
4,9% |
14,3% |
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
info@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 (UK)
Julia Phillips
Julia.Phillips@fticonsulting.com
Tel: +44 (0)203 727 1000
Natalie Garland-Collins
Natalie.Garland-Collins@fticonsulting.com
Tel: +44 (0)203 727 1000
iCorporate (Italy)
Elisa Piacentino
elisa.piacentino@icorporate.it
Tel: +39 02 4678754 - +39 366 9134595
Federica Casilli
federica.casilli@icorporate.com
Tel: +39 02 4678756
JV Public Relations NY (US)
Janet Vasquez
jvasquez@jvprny.com
Tel: + 1-212- 645-5498 - +1-917- 569-7470'
For full access, please click here.
Help employers find you! Check out all the jobs and post your resume.
