Download - Advanced Accelerator Applications

PRESS RELEASE
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:
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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
November 28, 2016, Saint-Genis-Pouilly, France - 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-onyear 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,
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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.
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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 cardiooncology indications.
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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 overexpressing 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,
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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.
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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 September
30, 2016
30, 2015
September September
30, 2016
30, 2015
in USD
(1)
thousands
In € thousands
In € thousands
Net loss for the period from continuing operations
Adjustments
Finance income
(including changes in fair value of contingent consideration)
Finance costs
(including changes in fair value of contingent consideration)
Income taxes
Depreciation and amortization
(7,016)
(6,243)
(1,818)
(10,651)
(10,281)
(480)
(427)
(447)
(812)
(160)
1,688
1,502
1,358
4,659
5,297
28
3,834
25
3,411
293
2,748
(422)
9,838
982
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 forwardlooking 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 forwardlooking 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
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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.
Contacts:
AAA Investor Relations
Jordan Silverstein
Director of Investor Relations
[email protected]
Tel: + 1-212-235-2394
AAA Corporate Communications
Rachel Levine
Director of Communications
[email protected]
Tel: + 1-212-235-2395
Media inquiries:
Makovsky & Company
Lee Davies
[email protected]
Tel: +212-508-9651
Axess Public Relations (Italy)
Dario Francolino
[email protected]
Tel: +39 3488818029
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CONDENSED CONSOLIDATED STATEMENTS OF INCOME
THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
Three months
September September
30, 2016
30, 2015
In € thousands
Sales
Raw materials and consumables used
Personnel costs
Other operating expenses
Other operating income
Depreciation and amortization
Operating loss
Finance income
(including changes in fair value of contingent consideration)
Nine months
September September
30, 2016
30, 2015
26,723
(6,072)
(10,789)
(12,098)
504
(3,411)
23,164
(4,827)
(7,535)
(10,201)
1,533
(2,748)
81,282
(17,268)
(29,716)
(34,925)
3,239
(9,838)
66,138
(13,918)
(20,505)
(31,879)
4,210
(8,208)
(5,143)
(614)
(7,226)
(4,162)
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)
(25)
(293)
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)
(0.08)
(0.08)
(0.03)
(0.03)
(0.14)
(0.14)
(0.16)
(0.16)
Income taxes
Loss per share
Basic (€ per share)
Diluted (€ per share)
422
(982)
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CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
THREE MONTHS AND NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
Three months
September September
30, 2016
30, 2015
(6,243)
(1,818)
In € thousands
Loss for the period
Nine months
September September
30, 2016
30, 2015
(10,651)
(10,281)
Other comprehensive income / (expense):
Items that may be reclassified subsequently to profit or loss
Exchange differences on translating foreign operations
Items that will never be reclassified subsequently to profit or loss
Remeasurement of defined benefit liability
Other comprehensive income / (expense) net of tax
(1)
25
9
34
(1,714)
(374)
2,173
(34)
38
(1,713)
(408)
2,211
1
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.
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CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
AT SEPTEMBER 30, 2016
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
NINE MONTHS ENDED SEPTEMBER 30, 2016 AND 2015
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