Positive CHMP Opinion for
Lutetium Lu 177 Dotatate* (Lutathera®) for
GEP-NETS
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 second quarter
ended June 30, 2017.
Stefano Buono, Chief Executive Officer of AAA,
commented, “We are pleased by our continued momentum as we move
through the second half of 2017. NETSPOT® remains a key driver for
revenue growth in our PET business, with almost 180 institutions in
the US actively administering the drug. The European roll out of
SomaKit TOC™ is also progressing well, with doses being sold in the
UK, Italy, Poland and Germany.”
“We have made great progress towards having our
first oncology theragnostic pairing for NETs on the market. The
positive CHMP opinion for lutetium Lu 177 dotatate* (Lutathera®) is
a historical first for Peptide Receptor Radionuclide Therapy
(PRRT), and we are hopeful that the recommended GEP-NET indication
will provide physicians with the ability to treat a broad range of
patients. We look forward to the European Commission’s final review
of the Marketing Authorization Application. Similarly, we are glad
to have completed the resubmission of our NDA to the FDA, so the
Agency’s review may continue. While this process unfolds, we will
keep working with US EAP centers to provide lutetium Lu 177
dotatate* (Lutathera®) to the now expanded eligible patient
population.”
Second Quarter 2017 Financial
Results
Total sales for the second quarter of 2017 were
€36.5 million (US$41.7 million(1)), a 32% increase compared to
€27.6 million (US$31.5 million(1)) in the second quarter of 2016.
The increase in sales was primarily driven by the PET product
category, which increased 50% to €25.2 million (US$28.8
million(1)), compared to €16.8 million (US$19.2 million(1)) in the
prior year period. This includes €7.2 million (US$8.2 million1) in
US sales of NETSPOT® in the second quarter. Therapeutic sales
for the second quarter were €5.4 million (US$6.2 million(1)),
compared to €5.6 million (US$6.4 million(1)). SPECT sales for the
second quarter were €2.5 million (US$2.9 million(1)), compared to
€2.4 million (US$2.7 million(1)) for the second quarter of 2016.
Second quarter sales of other products were €3.4 million (US$3.9
million(1)), compared to €2.9 million (US$3.3 million(1)) for the
same period in 2016.
Operating loss for the second quarter was €6.0
million (US$6.8 million(1)), compared to a loss of €1.0 million
(US$1.1 million(1)) for the prior year period. The Company
experienced higher personnel costs and operating expenses during
the second quarter of 2017, primarily related to the launch of new
products, ongoing pipeline development and increases in stock
option grants to employees and compliance requirements.
Net loss for the quarter was €9.9 million
(US$11.3 million(1)), compared to a net loss of €1.4 million
(US$1.6 million(1)) for the second quarter of 2016.
Adjusted EBITDA (see corresponding
reconciliation exhibit below) for the quarter was a loss of €2.2
million (US$2.5 million(1)) compared to a profit of €2.3 million
(US$2.6 million(1)) for the same period in 2016.
Cash, cash equivalents and short-term
investments at June 30, 2017 were €197 million (US$225
million(1)).
(1) Translated solely for convenience into US$ at the noon
buying rate of €1.00=$1.1411 at June 30, 2017.
Recent Operational Updates
On July 21, the CHMP of the EMA issued a
positive opinion recommending the marketing authorization of
lutetium Lu 177 dotatate* (Lutathera®) for the treatment of
unresectable or metastatic, progressive, well differentiated (G1
and G2), somatostatin receptor positive gastroenteropancreatic
neuroendocrine tumors (GEP-NETs) in adults.
On July 27, the Company announced that the
resubmission of the New Drug Application (NDA) for investigational
drug lutetium Lu 177 dotatate* (Lutathera®) to the FDA was
completed. On August 28, the Company announced that the FDA
acknowledged receipt and completeness of the submission and
provided a PDUFA date of January 26, 2018.
The company also announced that the FDA allowed
an amendment to the protocol for the US EAP for lutetium Lu 177
dotatate* (Lutathera®) to permit enrollment of patients with
metastasized or locally advanced, inoperable NETs arising at all
sites (including foregut, midgut and hindgut), and that have
progressive disease during or after treatment with somatostatin
analogues. In addition, the amendment includes the use of a 2.5%
lysine/arginine amino acid solution as an additional option for
renal protection.
Recently, extended data from the Phase I/II
study of lutetium Lu 177 dotatate* (Lutathera) at Erasmus Medical
Center in the Netherlands were published in Clinical Cancer
Research. Data from this study are included in the Company’s
Marketing Authorization Application to the EMA and in the NDA
submitted to the FDA. Of the 1,214 patients treated with lutetium
Lu 177 dotatate* from January 2000, to January 2015 at Erasmus, the
publication used data from 610 patients for safety analysis and 443
for efficacy and survival analysis. The paper concluded that PRRT
with lutetium Lu 177 dotatate* (Lutathera) produces good tumor
response rates for patients with grade 1–2 GEP-NETs and bronchial
NETs. It also noted that the side-effects are generally limited and
reversible in the short term in the majority of patients. Severe
long-term toxicities include acute leukemia or myelodysplastic
syndromes, occurring in 2% of patients. No therapy-related
long-term renal or hepatic failure was observed.
* USAN: lutetium Lu 177 dotatate/INN: lutetium (177Lu)
oxodotreotide
About USAN: lutetium
Lu 177 dotatate / INN: lutetium (177Lu)
oxodotreotide (Lutathera®)
USAN: lutetium Lu 177 dotatate/INN: lutetium
(177Lu) oxodotreotide (Lutathera®) is an investigational
177Lu-labeled somatostatin analog peptide. USAN: lutetium Lu 177
dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) belongs
to an emerging form of treatments called Peptide Receptor
Radionuclide Therapy (PRRT), which involves targeting tumors with
radiolabeled molecules that bind to specific receptors expressed by
the tumor. This novel compound has received orphan drug designation
from the European Medicines Agency (EMA) and the US Food and Drug
Administration (FDA). Currently, USAN: lutetium Lu 177
dotatate/INN: lutetium (177Lu) oxodotreotide (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). The Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has issued
a positive opinion for the treatment of gastroenteropancreatic
neuroendocrine tumors (GEP-NETs) in adults and a New Drug
Application submission to the FDA is currently under review.
About Advanced Accelerator Applications
S.A.
Advanced Accelerator Applications is an
innovative radiopharmaceutical company that develops, produces and
commercializes Molecular Nuclear Medicine products. AAA’s lead
investigational therapeutic candidate, USAN: lutetium Lu 177
dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®), is a
novel MNM compound in development for the treatment of
neuroendocrine tumors, a significant unmet medical need. Founded in
2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA
currently has 21 production and R&D facilities able to
manufacture both diagnostics and therapeutic MNM products, and more
than 500 employees in 13 countries (France, Italy, the UK, Germany,
Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium,
Israel, the US and Canada). AAA reported sales of €109.3 million in
2016 (+23% vs. 2015). 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 Computed 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 period from continuing operations for the three and
six months ended June 30, 2017 and 2016
|
Six months |
Three months |
|
Six months |
|
June 30, 2017 |
|
June 30, 2017 |
June 30, 2016 |
|
June 30, 2017 |
June 30, 2016 |
|
in USD thousands(1) |
|
In € thousands |
|
In € thousands |
|
|
|
|
|
|
|
|
Net loss for
the period from continuing
operations |
(24,181 |
) |
|
(9,913 |
) |
(1,432 |
) |
|
(21,191 |
) |
(4,408 |
) |
|
|
|
|
|
|
|
|
Adjustments |
|
|
|
|
|
|
|
Finance
income (including changes in fair value of contingent
consideration) |
(8,483 |
) |
|
(7,915 |
) |
(1,035 |
) |
|
(7,434 |
) |
(445 |
) |
Finance
costs (including changes in fair value of contingent
consideration) |
17,310 |
|
|
11,420 |
|
1,629 |
|
|
15,170 |
|
3,217 |
|
Income taxes |
1,124 |
|
|
433 |
|
(125 |
) |
|
985 |
|
(447 |
) |
Depreciation and
amortization |
8,466 |
|
|
3,809 |
|
3,228 |
|
|
7,419 |
|
6,427 |
|
|
|
|
|
|
|
|
|
Adjusted EBITDA |
(5,764 |
) |
|
(2,166 |
) |
2,265 |
|
|
(5,051 |
) |
4,344 |
|
Sales |
78,924 |
|
|
36,531 |
|
27,640 |
|
|
69,165 |
|
54,559 |
|
Adjusted EBITDA margin |
-7.30 |
% |
|
-5.93 |
% |
8.20 |
% |
|
-7.30 |
% |
7.96 |
% |
|
|
|
|
|
|
|
|
(1)
Translated solely for convenience into dollars at the noon buying
rate of EUR 1.00=USD 1.1411 at June 30, 2017. |
|
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains 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 that appear in a number of places in
this press release include the Company's current expectation
regarding future events and various matters, including expected
timing of filings with the FDA and EMA, approval dates and
expansion of NETSPOT®. 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 USAN: lutetium Lu 177
dotatate/INN: lutetium (177Lu) oxodotreotide (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 USAN: lutetium Lu 177
dotatate/INN: lutetium (177Lu) oxodotreotide (Lutathera®) and our
other products or product candidates; our estimates regarding the
market opportunity for USAN: lutetium Lu 177 dotatate/INN: lutetium
(177Lu) oxodotreotide (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 US; 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; regulatory actions or litigation; and
general economic, political, demographic and business conditions in
Europe, the US 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 AND SIX MONTHS ENDED JUNE 30, 2017 AND 2016
|
|
Three months |
|
Six months |
In €
thousands |
|
June 30, 2017 |
June 30, 2016 |
|
June 30, 2017 |
June 30, 2016 |
|
|
|
|
|
|
|
Sales |
|
36,531 |
|
27,640 |
|
|
69,165 |
|
54,559 |
|
Raw materials and
consumables used |
|
(8,531 |
) |
(5,572 |
) |
|
(16,832 |
) |
(11,196 |
) |
Personnel costs |
|
(14,200 |
) |
(9,248 |
) |
|
(26,534 |
) |
(18,927 |
) |
Other operating
expenses |
|
(17,032 |
) |
(11,992 |
) |
|
(33,099 |
) |
(22,913 |
) |
Other operating
income |
|
1,066 |
|
1,437 |
|
|
2,249 |
|
2,821 |
|
Depreciation and
amortization |
|
(3,809 |
) |
(3,228 |
) |
|
(7,419 |
) |
(6,427 |
) |
|
|
|
|
|
|
|
Operating loss |
|
(5,975 |
) |
(963 |
) |
|
(12,470 |
) |
(2,083 |
) |
|
|
|
|
|
|
|
Finance income
(including changes in fair value of contingent consideration) |
|
7,915 |
|
1,035 |
|
|
7,434 |
|
445 |
|
Finance costs
(including changes in fair value of contingent consideration) |
|
(11,420 |
) |
(1,629 |
) |
|
(15,170 |
) |
(3,217 |
) |
|
|
|
|
|
|
|
Net finance loss |
|
(3,505 |
) |
(594 |
) |
|
(7,736 |
) |
(2,772 |
) |
|
|
|
|
|
|
|
Loss before income taxes |
|
(9,480 |
) |
(1,557 |
) |
|
(20,206 |
) |
(4,855 |
) |
|
|
|
|
|
|
|
Income taxes |
|
(433 |
) |
125 |
|
|
(985 |
) |
447 |
|
|
|
|
|
|
|
|
Loss for the period |
|
(9,913 |
) |
(1,432 |
) |
|
(21,191 |
) |
(4,408 |
) |
|
|
|
|
|
|
|
Attributable
to: |
|
|
|
|
|
|
Owners of
the Company |
|
(9,913 |
) |
(1,432 |
) |
|
(21,191 |
) |
(4,408 |
) |
|
|
|
|
|
|
|
Loss per
share |
|
|
|
|
|
|
Basic (€ per
share) |
|
(0.11 |
) |
(0.02 |
) |
|
(0.24 |
) |
(0.06 |
) |
Diluted
(€ per share) |
|
(0.11 |
) |
(0.02 |
) |
|
(0.24 |
) |
(0.06 |
) |
Some non-significant figures in the six-month period ended June
30, 2016 were reclassified for comparison purposes, without impact
to net results.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
INCOME
THREE AND SIX MONTHS ENDED JUNE 30, 2017 AND 2016
|
|
Three months |
|
Six months |
In € thousands |
|
June 30, 2017 |
June 30, 2016 |
|
June 30, 2017 |
June 30, 2016 |
Loss for the period |
|
(9,913 |
) |
(1,432 |
) |
|
(21,191 |
) |
(4,408 |
) |
|
|
|
|
|
|
|
Other
comprehensive income /
(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Items that may
be reclassified subsequent to profit or loss |
|
|
|
|
|
|
Exchange
differences on translating foreign operations |
|
(324 |
) |
362 |
|
|
634 |
|
(399 |
) |
|
|
|
|
|
|
|
Items that will
never be reclassified subsequent to profit or loss |
|
|
|
|
|
|
Remeasurement of
defined benefit liability |
|
5 |
|
(6 |
) |
|
15 |
|
(43 |
) |
|
|
|
|
|
|
|
Other comprehensive income / (expense) net of tax
(1) |
|
(319 |
) |
356 |
|
|
649 |
|
(442 |
) |
Total comprehensive loss for the year |
|
(10,232 |
) |
(1,076 |
) |
|
(20,542 |
) |
(4,850 |
) |
|
|
|
|
|
|
|
Total
comprehensive loss attributable
to: |
|
|
|
|
|
|
Owners of the
Company |
|
(10,232 |
) |
(1,076 |
) |
|
(20,542 |
) |
(4,850 |
) |
|
|
|
|
|
|
|
(1) Negative tax effect of €8,000 at Q2 2017 and positive tax
effect of €3,000 at Q2 2016. |
Negative tax effect of €11,000 for the six months ended
June 30, 2017 and positive tax effect of €22,000 for the six months
ended |
June 30,
2016 |
|
|
|
|
|
|
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
AT JUNE 30, 2017 AND DECEMBER 31, 2016
|
|
|
ASSETS (in € thousands) |
June 30, 2017 |
December 31, 2016 |
Non-current assets |
143,656 |
|
149,695 |
|
Goodwill |
33,846 |
|
34,070 |
|
Other
intangible assets |
41,943 |
|
45,027 |
|
Property,
plant and equipment |
60,016 |
|
63,915 |
|
Financial
assets |
2,124 |
|
2,187 |
|
Other
non-current assets |
5,172 |
|
3,941 |
|
Deferred
Tax assets |
555 |
|
555 |
|
Current assets |
251,797 |
|
269,048 |
|
Inventories |
9,576 |
|
8,100 |
|
Trade and
other receivables |
36,376 |
|
31,079 |
|
Other
current assets |
8,892 |
|
7,789 |
|
Short-term investment |
22,000 |
|
- |
|
Cash and cash equivalents |
174,953 |
|
222,080 |
|
TOTAL ASSETS |
395,453 |
|
418,743 |
|
|
|
|
EQUITY AND LIABILITIES (in € thousands) |
June 30, 2017 |
December 31, 2016 |
Equity attributable to owners of the Company |
286,427 |
|
299,461 |
|
Share
capital |
8,833 |
|
8,795 |
|
Share
premium |
361,708 |
|
360,085 |
|
Reserves
and retained earnings |
(62,923 |
) |
(44,125 |
) |
Net loss for the period/year |
(21,191 |
) |
(25,294 |
) |
Total equity |
286,427 |
|
299,461 |
|
Non-current liabilities |
69,348 |
|
79,540 |
|
Non-current provisions |
14,060 |
|
12,725 |
|
Non-current financial liabilities |
10,987 |
|
12,302 |
|
Deferred
tax liabilities |
4,003 |
|
4,649 |
|
Other
non-current liabilities |
40,298 |
|
49,864 |
|
Current liabilities |
39,678 |
|
39,742 |
|
Current
provisions |
1,343 |
|
1,135 |
|
Current
financial liabilities |
3,423 |
|
4,017 |
|
Trade and
other payables |
20,159 |
|
20,119 |
|
Other
current liabilities |
14,753 |
|
14,471 |
|
Total liabilities |
109,026 |
|
119,282 |
|
TOTAL EQUITY AND LIABILITIES |
395,453 |
|
418,743 |
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
SIX MONTHS ENDED JUNE 30, 2017 AND 2016
|
Six months |
In € thousands |
June 30, 2017 |
June 30, 2016 |
Cash flows from operating activities |
|
|
Net loss
for the period |
(21,191 |
) |
(4,408 |
) |
|
|
|
Adjustments: |
|
|
Depreciation, amortization and impairment of non-current
assets |
7,419 |
|
6,427 |
|
Share
based payment expense |
5,847 |
|
2,545 |
|
Loss /
(Gain) on disposal of property, plant and equipment |
(8 |
) |
85 |
|
Financial result |
7,736 |
|
2,772 |
|
Income
tax expense |
985 |
|
(447 |
) |
Negative
goodwill |
- |
|
(127 |
) |
Subsidies income |
(183 |
) |
- |
|
Subtotal |
605 |
|
6,847 |
|
|
|
|
Increase
in inventories |
(1,575 |
) |
(1,242 |
) |
Increase
in trade receivables |
(5,747 |
) |
(5,026 |
) |
Increase
in trade payables |
375 |
|
1,307 |
|
Change
in other receivables and payables |
(2,737 |
) |
(7,469 |
) |
Increase
in provisions |
1,441 |
|
415 |
|
Change in working
capital |
(8,243 |
) |
(12,015 |
) |
|
|
|
Income
tax paid |
(1,103 |
) |
(1,266 |
) |
Net cash used in operating activities |
(8,741 |
) |
(6,434 |
) |
|
|
|
Cash flows from investing activities |
|
|
Acquisition of property, plant and equipment |
(2,248 |
) |
(7,950 |
) |
Acquisition of intangible assets |
(303 |
) |
(984 |
) |
Acquisition of financial assets |
(23 |
) |
(18 |
) |
Repayment of financial assets |
41 |
|
821 |
|
Acquisition of short-term investment |
(22,000 |
) |
- |
|
Interest
received |
860 |
|
287 |
|
Proceeds
from disposal of property, plant and equipment |
34 |
|
7 |
|
Net
proceeds from government grants |
362 |
|
- |
|
Acquisition of subsidiaries, net of cash acquired |
- |
|
(22,453 |
) |
Net cash used in investing activities |
(23,276 |
) |
(30,290 |
) |
|
|
|
Cash flows from financing activities |
|
|
Payment
of deferred and contingent liabilities to former owners of acquired
subsidiaries |
(3,553 |
) |
(2,870 |
) |
Exercice
of warrants |
1,661 |
|
- |
|
Proceeds
from borrowings |
332 |
|
- |
|
Repayment of borrowings |
(2,258 |
) |
(3,156 |
) |
Interests paid |
(216 |
) |
(177 |
) |
Other
finance costs payments |
(96 |
) |
- |
|
Net cash used in financing activities |
(4,130 |
) |
(6,203 |
) |
|
|
|
Net decrease in cash and cash equivalents |
(36,147 |
) |
(42,927 |
) |
|
|
|
Cash and
cash equivalents at the beginning of the year |
222,080 |
|
118,886 |
|
Effect
of exchange rate changes on cash and cash equivalents |
(10,980 |
) |
(220 |
) |
Cash and cash equivalents at the end of the
period |
174,953 |
|
75,739 |
|
Contacts:
AAA Corporate Communications
Rachel Levine
Director of Communications
rachel.levine@adacap.com
Tel: + 1-212-235-2395
AAA Investor Relations
Jordan Silverstein
Head of Investor Relations
jordan.silverstein@adacap.com
Tel: + 1-212-235-2394
Media inquiries:
Makovsky & Company
Lee Davies
ldavies@makovsky.com
Tel: +212-508-9651
ADVANCED ACCELERATOR APPLICATION (NASDAQ:AAAP)
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De Jun 2023 a Jun 2024