TIDM0RB9
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company
specializing in treatments for respiratory allergies, today
announced its full year results for the year ended 31 December
2017.
FY 2017 Financial
Highlights
(in H1 (unaudited) H2 (unaudited) Full Year (audited)
EUR million)
2017 2016 % change 2017 2016 % change 2017 2016 % change
Net sales 129.6 78.0 66% 130.6 108.2 21% 260.2 186.2 40%
Gross profit 83.4 34.7 140% 82.4 66.3 24% 165.8 101.1 64%
Gross margin 64% 45% 19 points 63% 61% 2 points 64% 54% 10 points
EBIT (3.5) (58.5) n.a. (1.9) (37.5) n.a. (5.4) (96.0) n.a.
Net (8.9) (39.0) n.a. (1.0) (21.5) n.a. (9.9) (60.5) n.a.
profit/(loss)
EBITDA 6.3 (45.1) n.a. 15.7 (22.9) n.a. 21.9 (67.9) n.a.
EBITDA 5% n.a. n.a. 12% n.a. n.a. 8% n.a. n.a.
margin
Fereydoun Firouz, Chairman and Chief Executive Officer of
Stallergenes Greer, commented:
"2017 was a pivotal year and the results we delivered are
evidence of the Group's transformation which began two years ago.
We met our financial guidance and returned to a positive EBITDA
representing a EUR90 million swing over 2016. We reached key
innovation milestones, including the completion of patient
enrolment in a Phase III trial for our house-dust mite tablet
candidate, STAGR320, and the publication of real-world data from
the BREATH studies, which notably demonstrated that Oralair®
improved control of allergic rhinitis and may have a preventive
effect on allergic asthma onset and progression compared to
symptomatic treatments.
We made significant progress commercially, delivering a 40%
increase in net sales year-over-year as a result of recapturing
market share across our product portfolio in all European
geographies and continuing to hold market leadership in the U.S.
subcutaneous treatment market.
In 2018, we will continue to focus on commercial execution,
optimizing our current product portfolio to gain further market
share, and developing new offerings to expand allergy immunotherapy
penetration in market segments where we see growth opportunities.
Our operational plan is focused on driving top line growth,
improving profitability, continuing our innovation path and
upgrading our technical operations capabilities."
Full-year net sales increased 40% as a result of market share
gains in European and International markets and sales growth of the
sublingual product category
Net sales by region: Europe and International grew
significantly; Leading position held in the U.S.
(in H1 (unaudited) H2 (unaudited) Full Year (audited)
EUR
million)
2017 2016 % change 2017 2016 % change 2017 2016 % change
Southern 53.7 17.8 202% 65.3 44.3 47% 119.0 62.1 91%
Europe
North 18.5 10.7 73% 15.2 12.4 22% 33.7 23.1 45%
&
Central
Europe
International 11.8 4.7 151% 7.8 7.4 6% 19.6 12.1 63%
United 45.6 44.8 2% 42.3 44.1 (4)% 87.9 88.9 (1)%
States
The 40% increase year-over-year in net sales reflects the
continued recapture of share in European markets and success in new
international markets following the temporary suspension of
production and distribution at our Antony site in late 2015, which
impacted sales in 2016. As of 31 December 2017, Oralair holds 38%
of the grass tablet market in France, a 13-percentage point gain
over 2016, and 34% of the grass tablet market in Germany, a
3-percentage point gain over last year.2 In addition, the Group
holds a market leadership position in Russia, Poland, the Balkans
and the Middle East, and regained share in Czech Republic and
Slovakia. Sales growth and market share gains were the result of a
refocused commercial organization and improved product supply lead
time.
In local currency (US$), revenue in the U.S. was up 1% in 2017.
In the grass tablet market, Oralair nearly doubled its share from
December 2016 while the overall market declined by 5%
year-over-year3. In the subcutaneous immunotherapy market,
Stallergenes Greer maintained its leading position with a strong
demand that exceeded supply.
Net sales by product category: Staloral® drove 83% growth in
sublingual; Subcutaneous grew 3%
(in H1 (unaudited) H2 (unaudited) Full Year (audited)
EUR
million)
2017 2016 % change 2017 2016 % change 2017 2016 % change
Sublingual4 76.9 27.3 182% 79.8 58.4 37% 156.7 85.7 83%
Subcutaneous5 36.9 34.2 8% 33.5 33.8 (1)% 70.4 68.0 3%
Other 10.8 11.1 (3)% 12.1 10.0 21% 22.9 21.1 9%
products6
Veterinary 5.0 5.4 (7)% 5.2 6.0 (14)% 10.2 11.4 (11)%
Full year 2017 sublingual product sales increased 83% to
EUR156.7 million from full year 2016, primarily due to the
performance of Staloral, which saw total sales increase 98%, or
EUR61.7 million, compared to 2016. The growth was mainly driven by
market share gains and, to some extent, by the industry-wide
shortage of subcutaneous immunotherapy treatments in Europe, which
resulted in switching of some patients to sublingual therapy.
Within the sublingual category, total tablet sales in 2017 reached
EUR30.5 million compared to EUR21.4 million in 2016, mainly driven
by Oralair market share growth in established markets. In the U.S.,
Oralair market share gained 15 points from 16% in 2016 to 31% in
2017. However, the market is growing more slowly than expected.
In the subcutaneous product category, the Group reported 2017
sales of EUR70.4 million, a 3% increase compared to 2016, driven by
growth in European and International markets while the U.S. market
remains flat. Sales from the other product category grew 9%
year-over-year to EUR22.9 million, and veterinary sales declined
11% to EUR10.2 million compared to 2016, due to increased
competition in this segment.
Operational efficiencies delivered margin improvement
The Group's full year 2017 gross margin of EUR165.8 million
represented 64% of net sales, compared to 54% in full year 2016.
The improvement is largely due to a global commitment to cost
management and a result of ongoing operational efficiency
initiatives. In addition, 2016 margins were impacted by costs
incurred during the temporary suspension of production and
distribution as well as the product recall in 2015.
The Group reduced its net loss from EUR60.5 million in 2016 to a
net loss of EUR9.9 million in 2017, and reported a positive 2017
EBITDA of EUR21.9 million, compared to an EBITDA loss of EUR67.9
million in 2016. EBITDA increased overall by EUR89.8 million
fuelled by a EUR74.0 million increase in sales and a decline in
Selling, General and Administrative expenses of 11%, from EUR148.2
million in 2016 to EUR131.9 million in 2017. In 2018, the Group
will continue to recalibrate operating expenditures and will
further review areas where efficiencies can be made, including the
Group's footprint and overhead costs. This commitment resulted in a
decision to reduce its administrative offices in the U.K., France
and the U.S.
As a result of the business recovery and robust measures to
contain costs, Stallergenes Greer continues to have a solid balance
sheet. At 31 December 2017, the Group's shareholders' equity
represented 83% of the balance sheet total.
As part of our annual reviews, the Group has performed an
impairment analysis of its intangible assets and goodwill in
accordance with IAS 36 (Impairment of Assets) for its
cash-generating units (CGU's). Based on our long range business
plan and related sensitivity scenarios around it, the value-in-use
of each CGU exceeds its carrying value and therefore no impairment
of goodwill has been recorded in the consolidated Group
accounts.
Group continues to invest in innovation to fuel long-term
growth
Stallergenes Greer is committed to developing innovative
therapies for major respiratory allergies and invested EUR45.6
million in R&D in 2017, primarily to fund STAGR320, the Group's
Phase III global multi-centre clinical trial for house dust mite
(HDM)-induced allergic rhinitis. In July 2017, Stallergenes Greer
announced completion of patient enrolment. With more than 1,600
patients enrolled, this study is the largest conducted study to
assess the efficacy and safety of a sublingual immunotherapy tablet
treatment.
This followed Stallergenes Greer's announcement in January 2017
of positive top-line results from its Phase III study for
paediatric HDM-induced allergic rhinitis in Japan. Results from
this study supported the March 2017 submission of a new drug
application for paediatric use of Actair (Stallergenes Greer's
commercial name for STAGR320 in registered markets) in Japan, which
was approved post-period in February 2018.
In September 2017, the Group received market approval to
commercialize STAGR320 in New Zealand under the Actair brand name
and in October 2017, Health Canada accepted for review the New Drug
Submission for STAGR320.
In addition to STAGR320, in June 2017, Stallergenes Greer
published results from BREATH (Bringing Real-World Evidence to
Allergy Treatment for Health), the first global, real-world
evidence studies demonstrating the long-term benefits of sublingual
immunotherapy to control allergic rhinitis and may reduce the risk
of the onset and progression of allergic asthma.
Investments in Quality and Technical Operations to continue
The AIT industry's manufacturing model is based on that of a
compounding pharmacy, with processes that must be continuously
updated to meet evolving regulatory requirements and comply with
the latest Good Manufacturing Process (GMP) biological
manufacturing standards. To address this and to ensure product
quality and patient safety for all released and distributed
products, Stallergenes Greer has made significant investments in
its Technical Operations and Quality capabilities over the past two
years, including modernizing manufacturing processes and
facilities.
As a result of these efforts and the Group's ongoing commitment
to quality, Stallergenes Greer successfully completed three U.S.
Food and Drug Administration (FDA) inspections in 2017 at its U.S.
facilities. Investments in Lenoir and San Diego will continue in
2018.
In France, the Group made significant progress on operational
systems upgrades at its Antony facility, resulting in the reduction
of the average product lead time to less than seven days7 compared
to the industry standard of two to three weeks. In addition, work
has continued to enhance quality control methods used for product
manufacturing and release. Meanwhile, an inspection conducted in
the fourth quarter of 2017 by the National Agency for Medicines and
Health Products Safety (ANSM) in France resulted in the issuance of
an injunction received on 4 January 2018. The injunction was
primarily related to the quality management system and processes at
the Antony facility, mostly for the production of subcutaneous
products. The remediation plan is well underway and the Group is
committed to working with the French authorities. Shipment delays
and temporary shortages of subcutaneous products are expected in
European and International markets through 2018.
2018 Business outlook
Stallergenes Greer made substantial progress in 2017 and will
continue to make strategic decisions in order to improve its
competitiveness and solidify its business fundamentals. This
includes investing in growth opportunities and delivering cost
efficiencies across the organization. The Group expects continued
progress in 2018, both through sales growth and strengthened
profitability. Stallergenes Greer expects:
-- net sales to grow mid-single digit percent in constant currency, and
-- EBITDA to be higher than 2017
---------------------------------------------------------
Stallergenes Greer plc recognized non-cash impairment with no
impact on Group consolidated accounts
As part of our annual reviews, Stallergenes Greer plc has
performed an impairment analysis of its "investments in subsidiary
undertakings" on its statutory accounts based on the latest long
range business plan and related sensitivity scenarios around it and
an impairment of EUR234 million was recorded. The impairment in the
statutory accounts for Stallergenes Greer plc has no impact on the
Group consolidated accounts, its 2017 operating result, EBITDA or
Equity8.
Webcast and Conference Call Information
Stallergenes Greer will host an Investors and Analysts meeting
today, 22 March 2018. The event will be available via live webcast
at 10:30 am GMT / 11:30 am CET / 6:30 am EDT. The webcast will be
available via the following link:
https://edge.media-server.com/m6/p/ptqhwgnv and on the company's
website,
http://stallergenesgreer.com/financial-calendar-events.
Please connect at least 15 minutes prior to the conference to
register, download and install any necessary audio software.
Financial Calendar
-- 16 April 2018: 2017 Annual Report Publication
-- 7 June 2018: Annual General Meeting
-- 30 August 2018: H1 2018 Results
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global
healthcare company specializing in the diagnosis and treatment of
allergies through the development and commercialization of allergy
immunotherapy products and services. Stallergenes Greer plc is the
parent company of GREER Laboratories, Inc. (whose registered office
is in the US) and Stallergenes SAS (whose registered office is in
France).
TRADING INFORMATION
Name: Stallergenes GreerISIN: GB00BZ21RF93 1 - Ticker: STAGRICB
Classification: 4577LEI: 213800CYVZA7GJQEME86Market: Euronext Paris
regulated market
Additional information is available at
http://www.stallergenesgreer.com.
This document (including information incorporated by reference
in this document), oral statements made and other information
published by the Company contain statements that are or may be
forward-looking with respect to the financial condition and/or
results of operations and businesses of the Company. These
statements can be identified by the use of forward-looking
terminology such as "believe," "expects," "project," "estimated,"
"forecast," "should," "plan," "may" or the negative of any of
these, or other variations thereof, or comparable terminology
indicating expectations or beliefs concerning future events. These
forward-looking statements include risk and uncertainty because
they relate to events and depend on circumstances that will occur
in the future. Without being exhaustive, such factors include
economic situations and business conditions, including legal and
product evaluation issues, fluctuations in currencies and demand,
and changes in competitive factors. These and other factors are
more fully described in the Company's 2016 annual report published
on 28 April 2017 on the Company's website
www.stallergenesgreer.com. Actual results may differ from those set
forth in the forward-looking statements, due to various factors.
Save as required by applicable law, neither the Company nor any
other person assumes any obligation to update these forward-looking
statements or to notify any person of any such update.
TABLE OF CONTENTS
Consolidated income statement as of 31 December 2017
Consolidated balance sheet as of 31 December 2017
Consolidated cash flow statement as of 31 December 2017
The financial information set out above does not constitute the
Group's financial statements for the period-ended 31 December 2017
but are derived from those statements. The annual report for 2017
will be made public on or before 30 April 2018 and delivered to the
UK Companies House on or before 30 June 2018. The auditor has
reported on those statements. Their report was unqualified, did not
draw attention to any matters by way of emphasis and did not
contain statements under Section 498 (2) or (3) Companies Act 2006
or equivalent preceding legislation. While the financial
information included in this preliminary announcement has been
computed in accordance with International Financial Reporting
Standards (IFRS), this announcement itself does not contain
sufficient information to comply with IFRS.
The Group published full financial statements that comply with
IFRS that are available on its website at
http://stallergenesgreer.com/annual-report.
The financial statements were approved by the Board of Directors
on 21 March 2018.
Consolidated income statement as of 31 December 2017
EUR thousands 31 December2017 31 December2016
Net sales1 260,195 186,247
Other revenues 36 141
Total revenues 260,231 186,388
Cost of goods sold (94,458) (85,331)
Gross margin 165,773 101,057
Distribution costs (11,413) (11,783)
Selling and marketing expenses (60,624) (63,943)
Administrative expenses (57,588) (67,316)
Other general expenses (2,281) (5,154)
Selling, general and administrative (131,906) (148,196)
expenses
Research and Development expenses (R&D) (45,630) (52,783)
R&D related income 6,412 7,379
Net R&D expenses (39,218) (45,404)
Operating loss (EBIT) before (5,351) (92,543)
transformation costs
Transformation costs - (3,506)
Operating loss (EBIT) (5,351) (96,049)
Financial income 20 609
Financial expenses (1,817) (699)
Net financial expense (1,797) (90)
Loss before tax and associates (7,148) (96,139)
Income tax (2,145) 35,773
Share of loss from associated companies (578) (156)
Loss for the period attributable to:
Owners of the parent (9,871) (60,522)
Non-controlling interest - -
Group share of net loss (9,871) (60,522)
1. The 2017 net sales figure includes a EUR5,112k unused
reversal of the recall provision against sales.
Consolidated balance sheet as of 31 December 2017
EUR thousands 31 December 31 December
2017 2016
Goodwill 195,187 216,550
Other intangible assets 70,913 90,428
Property, plant and equipment 69,138 80,304
Non-current financial assets* 3,957 6,011
Deferred tax assets 26,754 35,377
Other non-current assets 237 -
Non-current assets 366,186 428,670
Inventories 56,793 63,786
Trade receivables 33,199 41,826
Current financial assets* 684 13
Other current assets 9,231 8,810
Current income tax receivable 611 529
Research tax credit and subsidies receivable 22,708 15,468
Cash and cash equivalents 50,849 71,262
Current assets 174,075 201,694
Total assets 540,261 630,364
Share capital 19,788 19,788
Share premium 539 539
Merger and contribution premium 342,149 342,149
Revaluation reserve (236) -
Retained earnings 85,086 126,733
Group shareholders' equity 447,326 489,209
Non-controlling interests - -
Total shareholders' equity 447,326 489,209
Provision for employee retirement 3,442 4,488
obligations and related benefits
Non-current provisions 514 1,651
Non-current financial liabilities 6,318 6,753
Deferred tax liabilities 6,283 17,750
Non-current liabilities 16,557 30,642
Trade payables 19,793 26,658
Current provisions 2,115 3,180
Current financial liabilities 12,204 16,366
Income tax payable 1,313 1,217
Other current liabilities 40,953 63,092
Current liabilities 76,378 110,513
Total equity and liabilities 540,261 630,364
*The liquidity contract of the Group for EUR670k at 31 December
2017 (31 December 2016: EUR742k) has been reclassified from
non-current financial assets to current financial assets.
Consolidated cash flow statement as of 31 December 2017
EUR thousands 31 December 31 December
2017 2016
Cash flow from operating activities
Group share of net loss (9,871) (60,522)
Share of undistributed earnings 578 156
from investments
accounted for using the equity method
Tax 2,145 (35,773)
Net financial result 1,798 90
Amortisation and depreciation charges 23,404 27,682
Change in provision (1,904) (1,096)
Share-based compensation 2,429 1,117
Capital losses from disposal of assets 4,466 578
Financial losses excluding interests (35) 56
Operating cash flow before 23,010 (67,712)
changes in working capital
Current income tax paid (3,768) 4,612
Change in subsidies and R&D (7,240) (7,066)
tax credit receivables
Change in working capital (16,231) (7,244)
of operating activities
Change in deferred income 11 (675)
Net cash flow from operating activities (4,218) (78,085)
Cash flow from investing activities
Purchase of non-current assets (12,643) (22,015)
Acquisition of investments in consolidated (1,403) -
undertakings, net of cash acquired
Proceeds from sale of non-current assets1 5,269 19,509
Change in working capital (1,400) (2,547)
of investment activities
Net cash flow from investing activities (10,177) (5,053)
Free cash flow after investing activities (14,395) (83,138)
Cash flow from financing activities
Proceeds from issuance of ordinary shares - -
Treasury shares transactions (72) 20
Net financial interest paid (1,407) (583)
Use / (repayment) of bank overdrafts (227) (133)
Repayment of borrowings (15,054) (17,018)
Proceeds from borrowings 12,095 22,115
Net cash flow from financing activities (4,665) 4,401
Change in cash and cash equivalents (19,060) (78,737)
+ cash and cash equivalents 71,262 150,183
- opening balance
+/- effect of translation adjustment on (1,353) (184)
foreign currency denominated cash
= cash and cash equivalents 50,849 71,262
- closing balance
1. Included within proceeds from sale of non-current
assets are the proceeds
from sale of the DBV Technologies shares of EUR16,834k in 2016.
1 Guidance for 2017 was stated as "total revenue"; there is no
material difference between "net sales" and "total revenue".
Net sales stated in "constant currency" were determined using
the same exchange rates as the half-year 2017 results.
2 Source: IMS MIDAS
3 Source: Symphony Health Solutions and US Specialty
Pharmacy aggregated data internal data audit
4 Product category includes oral drops (Staloral)
and tablets (Oralair and Actair®)
5 Product category includes Named Patient Prescription
products and bulk allergens
6 Product category includes diagnostic and ancillary products
7 Not including backorders
8 For more information, please refer to note 4.5 in the Stallergenes
Greer plc, Company financial statements - www.stallergenesgreer.com.
Stallergenes Greer plcCommunications and Investor
RelationsNatacha Gassenbach, +1 617-225
8013natacha.gassenbach@stallergenesgreer.comorCaitlin Stefanik, +1
857-331 4117caitlin.stefanik@stallergenesgreer.comorMedia Relations
AgencyHavas Worldwide Paris (Europe)Lucas Heral, +33 6 77 01 47
49lucas.heral@havas.comorInvestor Relations AgencyFTI
ConsultingArnaud de Cheffontaines, +33 1 47 03 68
10stalleregenesgreer@fticonsulting.com
View source version on businesswire.com:
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(END) Dow Jones Newswires
March 22, 2018 03:00 ET (07:00 GMT)
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