Nov 1, 2017 SOURCE: PR NewsWire
Allergan Reports Solid Top-Line Execution in Third Quarter 2017 with 11% Increase in GAAP Net Revenues to $4.03 Billion
DUBLIN, Nov. 1, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today reported its third quarter 2017 continuing operations performance.
Third Quarter 2017 Continuing Operations
(unaudited; $ in millions, except Q3 '17 Q3 '16 Q2 '17 Q3 '17 v Q3 Q3 '17 v Q2 Nine Nine 2017
per share amounts) '16 '17 Months Months v
Ended Ended 2016
September September
30, 2017 30, 2016
--- -------- --------
Total net revenues** $4,034.3 $3,622.2 $4,007.4 11.4% 0.7% $11,614.6 $10,706.3 8.5%
------------------- -------- -------- -------- ---- --- --------- --------- ---
Operating (Loss) $(4,022.3) $(266.4) $(902.4) 1409.9% 345.7% $(5,830.7) $(925.5) 530.0%
--------------- --------- ------- ------- ------ ----- --------- ------- -----
Diluted EPS - Continuing Operations $(12.05) $(1.15) $(2.35) 947.8% 412.8% $(22.23) $(2.81) 691.1%
----------------------------------- ------- ------ ------ ----- ----- ------- ------ -----
SG&A Expense $1,169.7 $1,157.2 $1,395.0 1.1% (16.2)% $3,749.9 $3,463.5 8.3%
------------ -------- -------- -------- --- ------ -------- -------- ---
R&D Expense $442.6 $622.8 $489.4 (28.9)% (9.6)% $1,691.9 $1,662.4 1.8%
----------- ------ ------ ------ ------ ----- -------- -------- ---
Continuing Operations Tax Rate 29.3% 29.5% 44.8% (0.2)% (15.5)% 27.6% 48.0% (20.4)%
------------------------------ ---- ---- ---- ----- ------ ---- ---- ------
Non-GAAP Adjusted Operating Income $1,968.2 $1,784.4 $1,887.2 10.3% 4.3% $5,473.2 $5,376.6 1.8%
---------------------------------- -------- -------- -------- ---- --- -------- -------- ---
Non-GAAP Performance Net Income $4.15 $3.32 $4.02 25.0% 3.2% $11.51 $9.66 19.2%
Per Share
---------
Non-GAAP Adjusted EBITDA $2,051.7 $1,902.2 $2,027.2 7.9% 1.2% $5,813.1 $5,653.0 2.8%
------------------------ -------- -------- -------- --- --- -------- -------- ---
Non-GAAP SG&A Expense $1,099.6 $1,006.9 $1,216.5 9.2% (9.6)% $3,422.0 $3,014.7 13.5%
--------------------- -------- -------- -------- --- ----- -------- -------- ----
Non-GAAP R&D Expense $405.3 $386.4 $393.9 4.9% 2.9% $1,193.1 $1,007.9 18.4%
-------------------- ------ ------ ------ --- --- -------- -------- ----
Non-GAAP Continuing Operations 13.1% 8.2% 13.1% 4.9% 0.0% 13.1% 8.3% 4.8%
Tax Rate
--------
** Excludes the reclassification of revenues of ($23.7) million and ($80.0) million in the three and nine months ended September 30, 2016,
respectively, related to the portion of Allergan product revenues sold by our former Anda Distribution Business into discontinued operations.
Total net revenues were $4.03 billion, an 11.4 percent increase from the prior year quarter, driven by BOTOX(®), JUVÉDERM(®) Collection, LINZESS(®), ALLODERM(®), CoolSculpting(®) and new products, including VRAYLAR(TM), NAMZARIC(®) and VIBERZI(®). The increase was partially offset by lower revenues from MINASTRIN(®) and ASACOL(®) HD due to the loss of patent exclusivity, and the continuing decline in NAMENDA XR(®).
"Allergan's results and outlook demonstrate the foundational strength of our Company. Our 11 percent revenue growth in the third quarter was powered by significant year-over-year gains from many of our top products, including BOTOX(®), JUVÉDERM(®) Collection, LINZESS(®), ALLODERM(®) and CoolSculpting(®). We tightly managed our SG&A expenses, and our R&D team is making important progress across key programs, especially in advancing our six 'stars', including the NDA acceptance of Esmya for uterine fibroids," said Brent Saunders, Chairman and CEO of Allergan. "I continue to be very proud of our team and the work they are doing to advance patient care. Their focus and dedication, despite headwinds, is a hallmark of the bold team we have built at Allergan."
Regarding the RESTASIS(®) Federal District Court decision, Saunders added, "We have strong arguments for an appeal and we filed a notice of appeal with the Court. If a generic product enters the market, Allergan is ready to mitigate that impact by growing our base business, reducing costs and deploying our balance sheet. We will also deliver on our capital commitments, including increasing our dividend and paying down debt."
Third-Quarter 2017 Performance
GAAP operating loss from continuing operations in the third quarter 2017 was $4.02 billion, which includes the impact of amortization, asset sales and impairments, net, in-process research and development (R&D) impairments and foreign exchange transactional losses. Non-GAAP adjusted operating income from continuing operations in the third quarter of 2017 was $1.97 billion, an increase of 10.3 percent versus prior year quarter.
Operating Expenses
Total GAAP Selling, General and Administrative (SG&A) Expense was $1.17 billion for the third quarter 2017, compared to $1.16 billion in the prior year quarter. Total non-GAAP SG&A expense increased to $1.10 billion for the third quarter 2017, compared to $1.01 billion in the prior year period, primarily due to a period-over-period foreign exchange transactional loss of $67 million, as well as costs associated with the additions of the ALLODERM(®) and CoolSculpting(®) businesses. GAAP R&D investment for the third quarter of 2017 was $442.6 million, compared to $622.8 million in the third quarter of 2016. Non-GAAP R&D investment for the third quarter 2017 was $405.3 million, an increase of 4.9 percent over the prior year quarter, due to increased costs associated with clinical programs.
Asset Sales & Impairments, Net and In-Process R&D Impairments
The Company evaluated all of its dry eye related assets for impairment as a result of the U.S. District Court for the Eastern District of Texas issuing an adverse trial decision finding that the four asserted patents covering RESTASIS(®) (Cyclosporine Ophthalmic Emulsion) 0.05% are invalid. As a result of our review of all potential scenarios relating to these assets, the Company recognized an impairment of $3.2 billion related to RESTASIS(®), as well as an impairment of $164.0 million related to other Dry Eye IPR&D assets obtained in the Allergan acquisition in the three months ended September 30, 2017. The Company also impaired the intangible asset related to ACZONE(®) by $646.0 million as a result of branded acne market erosion. Additionally, the Company impaired an IPR&D asset acquired as part of the Warner Chilcott acquisition by $21.0 million in the three months ended September 30, 2017 ($278.0 million in the nine months ended September 30, 2017), due to a delay in anticipated launch of a women's healthcare project and an anticipated decrease in product demand. The Company excludes asset sales and impairments, net and in-process research and development impairments from its Non-GAAP performance net income attributable to shareholders as well as Adjusted EBITDA and Adjusted Operating Income.
Amortization, Other Income (Expense) Net, Tax and Capitalization
Amortization expense from continuing operations for the third quarter 2017 was $1.78 billion, compared to $1.61 billion in the third quarter of 2016. Included within other income (expense), net in the three months ended September 30, 2017 is the other-than-temporary impairment of Teva securities of $1.3 billion. The Company's GAAP continuing operations tax rate was 29.3 percent in the third quarter 2017. The Company's non-GAAP adjusted continuing operations tax rate was 13.1 percent in the third quarter 2017. As of September 30, 2017, Allergan had cash and marketable securities of $5.4 billion and outstanding indebtedness of $30.3 billion.
Discontinued Operations and Continuing Operations
As a result of the divestiture of the Company's generics business and the divestiture of the Company's Anda Distribution business in 2016, the financial results of those businesses have been reclassified to discontinued operations for all periods presented in our consolidated financial statements up through the date of the divestitures. Included in segment revenues in the three months ended September 30, 2016 are product sales that were sold by the Anda Distribution business once the Anda Distribution business had sold the product to a third-party customer. These sales are included in segment results and are excluded from total continuing operations revenues through a reduction to Corporate revenues. Cost of sales for these products in discontinued operations is equal to our average third-party cost of sales for third-party branded products distributed by Anda Distribution.
Third Quarter 2017 Business Segment Results
U.S. Specialized Therapeutics
Segment Information
(Unaudited; $ in millions) Three Months Ended September 30,
--------------------------------
2017 2016 (1)
---- -------
Eye Care $635.3 $608.5
Total Medical Aesthetics 602.3 388.9
Facial Aesthetics 314.9 293.7
Plastic Surgery 58.0 52.2
Regenerative Medicine 113.7 -
Body Contouring 83.4 -
Skin Care 32.3 43.0
Medical Dermatology 86.9 116.1
Neuroscience & Urology 380.4 330.7
Other Revenues 19.9 9.0
---- ---
Net revenues $1,724.8 $1,453.2
-------- --------
Operating expenses:
Cost of sales(2) 131.4 69.2
Selling and marketing 353.5 292.4
General and administrative 54.8 41.2
---- ----
Segment contribution $1,185.1 $1,050.4
======== ========
Segment margin 68.7% 72.3%
Segment gross margin(3) 92.4% 95.2%
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers.
(2) Excludes amortization and impairment of acquired intangibles including product rights as well as indirect cost of sales not attributable to segment results.
(3) Defined as net revenues less segment related cost of sales as a percentage of net revenues.
U.S. Specialized Therapeutics net revenues in the third quarter of 2017 were $1.7 billion, an increase of 18.7 percent versus prior year quarter, driven primarily by the addition of ALLODERM(®) and CoolSculpting(®), as well as growth in BOTOX(®), JUVÉDERM(®) Collection and Eye Care, offset by decreased revenues in Dermatology.
Eye Care
-- Allergan's Eye Care franchise delivered solid results versus prior year.
-- RESTASIS(®) net revenues of $366.8 million in the third quarter of
2017 increased 2.9 percent versus the prior year quarter.
-- The Glaucoma franchise remained stable with
ALPHAGAN(®)/COMBIGAN(®) net revenues in the third quarter of 2017
experiencing a modest decline to $92.7 million, while
LUMIGAN(®)/GANFORT(® )net revenues increased 6.4 percent versus
the prior year quarter to $83.3 million.
-- OZURDEX(®) net revenues in the third quarter of 2017 increased 17.7
percent from the prior year quarter to $24.6 million, driven by
continued strong demand.
Medical Aesthetics
-- The Facial Aesthetics franchise continues to deliver strong growth with
revenues increasing 7.2 percent versus prior year quarter.
-- BOTOX(®) Cosmetic net revenues in the third quarter of 2017 were
$189.7 million, up 8.7 percent versus prior year quarter, reflecting
continued strong volume growth.
-- JUVÉDERM(®) Collection (defined as JUVÉDERM(®), VOLUMA(®) and
other fillers) net revenues in the third quarter of 2017 were $115.6
million, up 10.1 percent versus prior year quarter, driven by
continued strong demand and market share gains.
-- KYBELLA(®) net revenues in the third quarter of 2017 were $9.6
million, a decrease of 32.4 percent from the prior year quarter,
primarily due to the impact of lower promotional effort in the third
quarter of 2017 versus prior year.
-- Regenerative Medicine
-- ALLODERM(®) net revenues in the third quarter of 2017 were $84.6
million.
-- STRATTICE(TM) net revenues, a component of "Other Regenerative
Medicine," were $26.6 million in the third quarter of 2017.
-- Body Contouring
-- CoolSculpting(®) net revenues (including both CoolSculpting(®)
Systems/Applicators and Consumables) in the third quarter of 2017
were $83.4 million.
-- Plastic Surgery
-- Breast implant net revenues in the third quarter of 2017 were $58.0
million, an increase of 13.5 percent versus prior year quarter,
driven by higher demand following the launch of INSPIRA(TM) breast
implants.
-- Skin Care
-- SkinMedica(®) net revenues in the third quarter of 2017 were $18.7
million, a decrease of 27.5 percent compared with the third quarter
of 2016, due to timing of promotional programs.
Medical Dermatology
-- ACZONE(®) net revenues in the third quarter of 2017 were $46.7 million,
a decrease of 32.3 percent, primarily impacted by generic pressure on
the branded acne category and higher discounts for formulary coverage.
-- TAZORAC(®) net revenues in the third quarter of 2017 were $15.1
million, a decrease of 45.1 percent, primarily due to continued generic
competition.
Neurosciences & Urology
-- BOTOX(®) Therapeutic net revenues in the third quarter of 2017 were
$352.1 million, an increase of 15.3 percent versus the prior year
quarter, primarily driven by continued strong demand in the chronic
migraine and adult spasticity indications.
-- RAPAFLO(®) net revenues in the third quarter of 2017 were $28.3
million, an increase of 12.3 percent versus prior year quarter.
U.S. Specialized Therapeutics gross margin for the third quarter of 2017 was 92.4 percent, impacted by the contribution of the ALLODERM(®) and CoolSculpting(®) businesses. SG&A expenses in the segment for the third quarter 2017 were $408.3 million. Selling and marketing expenses in the segment for the third quarter 2017 were $353.5 million, an increase of 21 percent versus prior year quarter mainly attributed to the contribution of the ALLODERM(®) and CoolSculpting(®) businesses. General and administrative expenses at the segment level for the third quarter 2017 were $54.8 million, an increase of 33 percent versus prior year quarter, attributed in part to the addition of the ALLODERM(®) and CoolSculpting(®) businesses. Segment contribution for the third quarter 2017 remained strong at $1.19 billion, an increase of 13 percent versus the prior year quarter, driven by increased revenues following recent acquisitions.
U.S. General Medicine
Segment Information
(Unaudited; $ in millions) Three Months Ended September 30,
--------------------------------
2017 2016 (1)
---- -------
Central Nervous System $355.2 $325.5
Gastrointestinal 443.5 431.4
Women's Health 265.7 305.3
Anti-Infectives 67.2 52.5
Diversified Brands 318.7 319.3
Other Revenues 47.1 54.1
---- ----
Net revenues $1,497.4 $1,488.1
-------- --------
Operating expenses:
Cost of sales(2) 225.5 215.1
Selling and marketing 247.7 292.8
General and administrative 47.7 42.3
---- ----
Segment contribution $976.5 $937.9
====== ======
Segment margin 65.2% 63.0%
Segment gross margin(3) 84.9% 85.5%
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers.
(2) Excludes amortization and impairment of acquired intangibles including product rights as well as indirect cost of sales not attributable to segment results.
(3) Defined as net revenues less segment related cost of sales as a percentage of net revenues.
U.S. General Medicine net revenues in the third quarter 2017 were $1.5 billion, remaining stable versus the prior year quarter, driven by strong growth from LINZESS(®), VRAYLAR(TM), NAMZARIC(®) and Lo LOESTRIN(®), offset by lower revenues from MINASTRIN(®), ASACOL(®) and NAMENDA XR( ®) due to generic competition and product conversion.
Central Nervous System
-- NAMENDA XR(®) net revenues in the third quarter of 2017 were $114.3
million, a decrease of 22.2 percent versus the prior year quarter,
driven primarily by lower demand as a result of a reduction in
promotional support and continued conversion to NAMZARIC(®).
-- NAMZARIC(®) net revenues in the third quarter of 2017 increased to
$37.0 million from $14.9 million in the prior year quarter driven by
increased demand.
-- VRAYLAR(TM) net revenues in the third quarter of 2017 were strong at
$80.2 million, driven by demand growth.
-- VIIBRYD(®)/FETZIMA(®) net revenues in the third quarter of 2017 were
$86.5 million, a decrease of 1.3 percent versus the prior year quarter.
-- SAPHRIS(®) net revenues in the third quarter of 2017 were $37.2
million, a decrease of 8.8 percent versus the prior year quarter,
primarily impacted by lower demand.
Gastrointestinal
-- LINZESS(®) net revenues in the third quarter of 2017 were $190.9
million, an increase of 16.1 percent versus prior year quarter, driven
by strong demand growth and favorable year-over-year trade buying
patterns.
-- VIBERZI(®) net revenues in the third quarter of 2017 were $40.9
million, driven by continued demand growth.
-- ASACOL(®)/DELZICOL(®) net revenues in the third quarter of 2017 were
$49.5 million, a decrease of 31.4 percent versus the prior year quarter,
impacted by generic entry for ASACOL(® )HD and a decline in demand for
DELZICOL(®).
-- ZENPEP(®) net revenues in the third quarter of 2017 were $56.8, an
increase of 8.2 percent versus the prior year quarter.
-- CARAFATE(®)/SULCRATE(® )net revenues in the third quarter of 2017 were
$58.7 million, an increase of 4.1 percent versus the prior year quarter.
Women's Health
-- Lo LOESTRIN(®) net revenues in the third quarter of 2017 were $120.0
million, up 13.5 percent versus prior year quarter, driven by strong
prescription growth and higher average selling prices. Lo LOESTRIN(®)
remains the number one prescribed branded oral contraceptive.
-- ESTRACE(®) Cream net revenues in the third quarter were $101.6 million,
an increase of 3.0 percent versus prior year quarter.
-- MINASTRIN(®) 24 net revenues in the third quarter of 2017 were $3.6
million, a decrease of 95.8 percent versus prior year quarter, impacted
by loss of patent exclusivity for MINASTRIN(®) 24 on March 15, 2017.
-- TAYTULLA(TM) net revenues, a component of "Other Women's Health," were
$21.0 million in the third quarter of 2017 following launch of this new
oral contraceptive soft gel product in November 2016.
Anti-Infectives
-- TEFLARO(®) net revenues in the third quarter of 2017 were $29.1
million, a decrease of 12.6 percent versus prior year quarter, primarily
impacted by generic competition in the category.
-- DALVANCE(®) net revenues in the third quarter of 2017 were $16.1
million compared to $10.3 million in the prior year quarter, driven by
increasing demand.
-- AVYCAZ(®) net revenues in the third quarter of 2017 were $16.9 million
versus $4.8 million in the third quarter of 2016, a period of supply
disruption.
Diversified Brands and Other Products
-- Diversified Brands net revenues in the third quarter of 2017 were stable
at $318.7 million, compared to $319.3 million in the prior year quarter.
-- Within Diversified Brands, BYSTOLIC(®)/BYVALSON(®) net revenues in the
third quarter of 2017 were stable at $164.2 million. BYSTOLIC(®)
remains the flagship product of Allergan's primary care sales force.
U.S. General Medicine gross margin for the third quarter of 2017 decreased to 84.9 percent as unfavorable product mix offset the impact of the Company reacquiring rights to select licensed products in the segment, which had the impact of lowering royalty expense on these products. SG&A expenses in the segment were $295.4 million in the third quarter of 2017. Selling and marketing expenses in the segment were $247.7 million, a decrease of 15 percent versus prior year quarter, due to a decrease in sales force and other promotional expenses. General and administrative expenses increased to $47.7 million at the segment level. Segment contribution for the third quarter 2017 was $976.5 million.
International
Segment Information
(Unaudited; $ in millions) Three Months Ended September 30,
--------------------------------
2017 2016
---- ----
Eye Care $317.9 $294.2
Total Medical Aesthetics 331.1 251.0
Facial Aesthetics 259.6 212.6
Plastic Surgery 38.5 35.8
Regenerative Medicine 5.1 -
Body Contouring 24.0 -
Skin Care 3.9 2.6
Botox Therapeutics and Other 141.8 134.6
Other Revenues 17.0 18.0
---- ----
Net revenues $807.8 $697.8
------ ------
Operating expenses:
Cost of sales(1) 116.3 95.1
Selling and marketing 224.8 188.2
General and administrative 28.3 28.0
---- ----
Segment contribution $438.4 $386.5
====== ======
Segment margin 54.3% 55.4%
Segment gross margin (2) 85.6% 86.4%
(1) Excludes amortization and impairment of acquired intangibles including product rights as well as indirect cost of sales not attributable to segment results.
(2) Defined as net revenues less segment related cost of sales as a percentage of net revenues.
International net revenues were $807.8 million, an increase of 13.7 percent versus prior year quarter excluding foreign exchange impact, driven by growth in Facial Aesthetics, Eye Care and the addition of CoolSculpting(®).
Medical Aesthetics
-- Facial Aesthetics
-- BOTOX(®) Cosmetic net revenues in the third quarter of 2017 were
$131.5 million, an increase of 15.3 percent versus prior year
quarter excluding foreign exchange impact, driven by continued
strong growth in Latin America/Canada and Asia Pacific/Middle
East/Africa.
-- JUVÉDERM(®) Collection net revenues in the third quarter of 2017
were $126.5 million, an increase of 27.8 percent versus prior year
quarter excluding foreign exchange impact, reflecting continued
strong performance across all regions.
-- Plastic Surgery
-- Breast implant net revenues in the third quarter of 2017 were $38.1
million, an increase of 7.0 percent versus prior year quarter,
excluding foreign exchange impact.
-- Body Contouring
-- CoolSculpting(®) net revenues (including both CoolSculpting(®)
Systems/Applicators and Consumables) in the third quarter of 2017
were $24.0 million.
Eye Care
-- LUMIGAN(®)/GANFORT(®) and ALPHAGAN(®)/COMBIGAN(®) net revenues in
the third quarter of 2017 were $91.5 million and $43.4 million,
respectively, reflecting continued stable performance across Allergan's
glaucoma product franchise.
-- OZURDEX(®) net revenues in the third quarter of 2017 were $50.2
million, up 12.0 percent versus prior year quarter excluding foreign
exchange impact, reflecting strong demand across all regions.
-- OPTIVE(®) net revenues in the third quarter of 2017 were $28.4 million,
up 7.0 percent versus prior year quarter excluding foreign exchange
impact, reflecting strong demand in Latin America/Canada and Asia
Pacific/Middle East/Africa.
Botox Therapeutic & Other Products
-- BOTOX(®) Therapeutic net revenues in the third quarter of 2017 were
$84.4 million, up 4.9 percent versus prior year quarter excluding
foreign exchange impact.
-- ASACOL(®)/DELZICOL(®) revenues in the third quarter of 2017 were $11.9
million, a decrease of 17.6 percent versus prior year quarter excluding
foreign exchange impact.
International gross margin for the third quarter of 2017 was 85.6 percent. SG&A expenses in the segment were $253.1 million in the third quarter of 2017. Selling and marketing expenses in the segment were $224.8 million, an increase of 17 percent versus prior year excluding foreign exchange impact, in line with higher sales and the addition of CoolSculpting(®). Segment contribution was $438.4 million.
Corporate Function
Included within our corporate function are shared costs, including above site and unallocated costs associated with running our global manufacturing facilities, corporate general and administrative expenses and corporate initiatives.
Pipeline Update
Allergan R&D continues to deliver on its pipeline. Key development highlights included:
U.S. and International Branded Product Approvals and Launches
-- Allergan received approval from the U.S. Food and Drug Administration
(FDA) for BOTOX(®) Cosmetic for the temporary improvement in the
appearance of moderate to severe forehead lines associated with
frontalis muscle activity in adults. This marks the third approved
indication for BOTOX(®) Cosmetic, in addition to crow's feet and
glabellar lines.
Regulatory Milestones & Clinical Updates
-- Allergan announced the FDA has accepted the New Drug Application (NDA)
for ulipristal acetate, an investigational drug for the treatment of
abnormal uterine bleeding in women with uterine fibroids.
-- Allergan announced the FDA has accepted a supplemental New Drug
Application (sNDA) for AVYCAZ(®) (ceftazidime and avibactam) for
priority review. The sNDA filing seeks to expand the current indications
for AVYCAZ(®) to include hospital-acquired bacterial
pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) in adult
patients based on positive results from a Phase 3 clinical trial
evaluating AVYCAZ(®) for the treatment of patients with HABP/VABP. The
FDA granted priority review status to the application based on the
previous Qualified Infectious Disease Product (QIDP) designation for
AVYCAZ(®), and is expected to take action on the filing in the first
quarter of 2018.
-- Allergan announced top-line results from new data for the CENTAUR Phase
2b study which supports the anti-fibrotic efficacy and safety of
Cenicriviroc (CVC) for the treatment of liver fibrosis in adults with
NASH. The Company plans to conduct additional subanalyses of the CENTAUR
study and will discuss the data with regulatory authorities to determine
whether study modifications may be required. Allergan is currently
enrolling patients in a 2,000-patient phase 3 clinical trial of CVC. The
primary composite endpoint in the AURORA trial is reduction in fibrosis
by at least one stage with no worsening of NASH at one year.
-- Allergan received a Refusal to File (RTF) letter from the FDA regarding
its Supplemental New Drug Application (sNDA) for VRAYLAR(TM)
(cariprazine) for treatment of negative symptoms associated with
schizophrenia in adult patients. Under its preliminary review, FDA
determined that the sNDA for treatment of negative symptoms was not
sufficiently complete to permit a substantive review. Allergan has
scheduled a meeting with the FDA in December to address the issues in
the RTF letter.
-- Allergan initiated patient screening in a Phase 3 study of Relamorelin,
the Company's ghrelin agonist being studied as a treatment for diabetic
gastroparesis. Allergan expects to begin dosing patients in the Phase 3
study in the coming weeks.
Allergan Narrows Full Year 2017 Non-GAAP Continuing Operations Guidance
Previous Guidance Current Guidance
----------------- ----------------
Full Year 2017 GAAP NON-GAAP GAAP NON-GAAP
-------------- ---- -------- ---- --------
Total Net Revenues $15,850 - $16,050 $15,850 - $16,050 $15,875 - $16,025 $15,875 - $16,025
million million million million
--- ------- ------- ------- -------
Gross Margin (as a % of revenues) ~86.0% - 86.5% ~86.5% - 87.0% ~86.0% - 86.5% ~86.5-87.0%
-------------------------------- ------------- ------------- ------------- ----------
SG&A Expense ~$4.950 - $5.050 ~$4.500 - $4.600 ~$4.950 - $5.050 ~$4.500 - $4.600
billion billion billion billion
--- ------- ------- ------- -------
R&D Expense ~$2.15 billion ~$1.60 billion ~$2.15 billion ~$1.60 billion
----------- -------------- -------------- -------------- --------------
Net Interest Expense/Other Income (Expense) ~$3.05 billion ~$1.00 billion ~$4.35 billion ~$1.00 billion
------------------------------------------- -------------- -------------- -------------- --------------
Tax Rate(1) ~25.5% ~13.0% ~36% ~13.0%
---------- ----- ----- --- -----
Net Income / (Loss) Per Share(2) $(10.80) - $(11.20) $16.05 - $16.45 $(20.05) - $(20.35) $16.15 - $16.45
-------------------------------- ------------------ --------------- ------------------ ---------------
Average 2017 Share Count(3) ~334 million shares ~356 million shares ~334 million shares ~356 million shares
-------------------------- ------------------- ------------------- ------------------- -------------------
1 Includes the net tax benefit of approximately $795.0 million resulting from changes to the internal structure of the Company
that occurred in October 2017. This is due to certain temporary differences expected to reverse at tax rates different than what was
originally recorded.
2 GAAP represents EPS for ordinary shareholders. GAAP (loss) per share includes the impact of amortization of approximately
$7.2 billion, IPR&D impairments and asset sales and impairments, net of $5.15 billion and dividends on preferred shares of
approximately $278 million. Non-GAAP represents performance net income per share.
3 GAAP EPS shares do not include dilution of shares as earnings are a net loss. As such, the dilution impact of preferred share
conversion and outstanding equity awards is not included in the forecasted shares.
Third Quarter 2017 Conference Call and Webcast Details
Allergan will host a conference call and webcast today, Wednesday, November 1, at 8:30 a.m. Eastern Time to discuss its third quarter 2017 results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 65879759. A taped replay of the conference call will also be available beginning approximately two hours after the call's conclusion, and will remain available through 11:30 p.m. Eastern Time on December 1, 2017. The replay may be accessed by dialing (855) 859-2056 and entering the conference ID 65879759. From international locations, the replay may be accessed by dialing (404) 537-3406 and entering the same conference ID.
To access the live webcast, please visit Allergan's Investor Relations Web site at https://www.allergan.com/investors. A replay of the webcast will also be available.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 60+ mid-to-late stage pipeline programs currently in development.
Allergan's success is powered by our more than 18,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com.
Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; the impact of uncertainty around timing of generic entry related to key products, including RESTASIS(®), on our financial results; uncertainty associated with financial projections, projected cost reductions, projected synergies, restructurings, increased costs, and adverse tax consequences; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
The following presents Allergan plc's statement of operations for the three and nine months ended September 30,
2017 and 2016:
Table 1
ALLERGAN PLC
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited; in millions, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2017 2016 2017 2016
---- ---- ---- ----
Net revenues $4,034.3 $3,622.2 $11,614.6 $10,706.3
-------- -------- --------- ---------
Operating expenses:
Cost of sales (excludes amortization and impairment of 586.5 462.2 1,587.1 1,381.1
acquired intangibles including product rights)
Research and development 442.6 622.8 1,691.9 1,662.4
Selling, general and administrative 1,169.7 1,157.2 3,749.9 3,463.5
Amortization 1,781.0 1,609.1 5,274.9 4,831.9
In-process research and development impairments 202.0 42.0 1,245.3 316.9
Asset sales and impairments, net 3,874.8 (4.7) 3,896.2 (24.0)
------- ---- ------- -----
Total operating expenses 8,056.6 3,888.6 17,445.3 11,631.8
------- ------- -------- --------
Operating (loss) (4,022.3) (266.4) (5,830.7) (925.5)
-------- ------ -------- ------
Non-operating income (expense):
Interest income 11.1 18.1 53.0 23.5
Interest (expense) (265.2) (324.3) (832.3) (1,002.9)
Other income (expense), net (1,310.3) 33.6 (3,366.6) 184.2
-------- ---- -------- -----
Total other income (expense), net (1,564.4) (272.6) (4,145.9) (795.2)
-------- ------ -------- ------
(Loss) before income taxes and noncontrolling interest (5,586.7) (539.0) (9,976.6) (1,720.7)
(Benefit) for income taxes (1,638.8) (158.9) (2,752.1) (825.8)
-------- ------ -------- ------
Net (loss) from continuing operations, net of tax (3,947.9) (380.1) (7,224.5) (894.9)
(Loss) / income from discontinued operations, net of tax (6.1) 15,601.9 (17.6) 15,873.2
---- -------- ----- --------
Net (loss) / income (3,954.0) 15,221.8 (7,242.1) 14,978.3
-------- -------- -------- --------
(Income) attributable to noncontrolling interest (1.7) (1.8) (4.7) (4.3)
---- ---- ---- ----
Net (loss) / income attributable to shareholders (3,955.7) 15,220.0 (7,246.8) 14,974.0
-------- -------- -------- --------
Dividends on preferred shares 69.6 69.6 208.8 208.8
---- ---- ----- -----
Net (loss) / income attributable to ordinary shareholders $(4,025.3) $15,150.4 $(7,455.6) $14,765.2
========= ========= ========= =========
(Loss) / income per share attributable to ordinary shareholders -
basic:
Continuing operations $(12.05) $(1.15) $(22.23) $(2.81)
Discontinued operations (0.02) 39.73 (0.05) 40.25
----- ----- ----- -----
Net (loss) /income per share - basic $(12.07) $38.58 $(22.28) $37.44
======= ====== ======= ======
(Loss) / income per share attributable to ordinary shareholders -
diluted:
Continuing operations $(12.05) $(1.15) $(22.23) $(2.81)
Discontinued operations (0.02) 39.73 (0.05) 40.25
----- ----- ----- -----
Net (loss) /income per share - diluted $(12.07) $38.58 $(22.28) $37.44
======= ====== ======= ======
Dividends per ordinary share $0.70 $ - $2.10 $ -
Weighted average shares outstanding:
Basic 333.5 392.7 334.6 394.4
===== ===== ===== =====
Diluted 333.5 392.7 334.6 394.4
===== ===== ===== =====
The following table details Allergan plc's product revenue for significant promoted products globally, within the U.S., and international for the three and nine months ended September 30, 2017 and 2016.
Table 2
ALLERGAN PLC
NET REVENUES TOP GLOBAL PRODUCTS
(Unaudited; in millions)
Three Months Ended September 30, 2017 Three Months Ended September 30, 2016 Movement
------------------------------------- ------------------------------------- --------
US Specialized US General International Corporate Total US Specialized US General International Corporate Total Total Total Change
Therapeutics Medicine Therapeutics Medicine Percentage
Change
------
Botox(R) $558.6 $ - $215.9 $ - $774.5 $496.3 $ - $193.4 $ - $689.7 $84.8 12.3%
Restasis(R) 366.8 - 15.5 - 382.3 356.4 - 15.4 - 371.8 10.5 2.8%
Juvederm Collection** 115.6 - 126.5 - 242.1 105.0 - 96.8 - 201.8 40.3 20.0%
Linzess(R)/Constella(R) - 190.9 5.7 - 196.6 - 164.4 4.3 - 168.7 27.9 16.5%
Lumigan(R)/Ganfort(R) 83.3 - 91.5 - 174.8 78.3 - 86.6 - 164.9 9.9 6.0%
Bystolic(R) /Byvalson(R) - 164.2 0.5 - 164.7 - 165.1 0.5 - 165.6 (0.9) (0.5)%
Alphagan(R)/Combigan(R) 92.7 - 43.4 - 136.1 93.4 - 41.3 - 134.7 1.4 1.0%
Eye Drops 53.7 - 71.2 - 124.9 50.2 - 67.7 - 117.9 7.0 5.9%
Lo Loestrin(R) - 120.0 - - 120.0 - 105.7 - - 105.7 14.3 13.5%
Namenda XR(R) - 114.3 - - 114.3 - 146.9 - - 146.9 (32.6) (22.2)%
Estrace(R) Cream - 101.6 - - 101.6 - 98.6 - - 98.6 3.0 3.0%
Breast Implants 58.0 - 38.1 - 96.1 51.1 - 35.6 - 86.7 9.4 10.8%
Viibryd(R)/Fetzima(R) - 86.5 1.0 - 87.5 - 87.6 - - 87.6 (0.1) (0.1)%
Alloderm 84.6 - 1.5 - 86.1 - - - - - 86.1 n.a.
Vraylar(TM) - 80.2 - - 80.2 - 32.4 - - 32.4 47.8 147.5%
Ozurdex (R) 24.6 - 50.2 - 74.8 20.9 - 43.4 - 64.3 10.5 16.3%
Coolsculpting Consumables 50.3 - 13.8 - 64.1 - - - - - 64.1 n.a.
Asacol(R)/Delzicol(R) - 49.5 11.9 - 61.4 - 72.2 14.2 - 86.4 (25.0) (28.9)%
Carafate (R) /Sulcrate (R) - 58.7 0.7 - 59.4 - 56.4 0.6 - 57.0 2.4 4.2%
Zenpep(R) - 56.8 - - 56.8 - 52.5 - - 52.5 4.3 8.2%
Aczone(R) 46.7 - 0.2 - 46.9 69.0 - - - 69.0 (22.1) (32.0)%
Canasa(R)/Salofalk(R) - 39.0 4.6 - 43.6 - 47.2 4.4 - 51.6 (8.0) (15.5)%
Coolsculpting Systems & Add On Applicators 33.1 - 10.2 - 43.3 - - - - - 43.3 n.a.
Viberzi(R) - 40.9 0.2 - 41.1 - 30.9 - - 30.9 10.2 33.0%
Armour Thyroid - 38.5 - - 38.5 - 39.1 - - 39.1 (0.6) (1.5)%
Saphris(R) - 37.2 - - 37.2 - 40.8 - - 40.8 (3.6) (8.8)%
Namzaric(R) - 37.0 - - 37.0 - 14.9 - - 14.9 22.1 148.3%
Rapaflo(R) 28.3 - 1.8 - 30.1 25.2 - 1.5 - 26.7 3.4 12.7%
Teflaro(R) - 29.1 - - 29.1 - 33.3 - - 33.3 (4.2) (12.6)%
Savella(R) - 24.0 - - 24.0 - 28.1 - - 28.1 (4.1) (14.6)%
SkinMedica(R) 18.7 - 1.4 - 20.1 25.8 - - - 25.8 (5.7) (22.1)%
Avycaz(R) - 16.9 - - 16.9 - 4.8 - - 4.8 12.1 n.m.
Dalvance(R) - 16.1 - - 16.1 - 10.3 - - 10.3 5.8 56.3%
Latisse(R) 13.6 - 1.9 - 15.5 17.2 - 1.9 - 19.1 (3.6) (18.8)%
Tazorac(R) 15.1 - 0.1 - 15.2 27.5 - 0.2 - 27.7 (12.5) (45.1)%
Lexapro(R) - 12.9 - - 12.9 - 15.6 - - 15.6 (2.7) (17.3)%
Kybella(R) /Belkyra(R) 9.6 - 1.6 - 11.2 14.2 - 0.5 - 14.7 (3.5) (23.8)%
Liletta(R) - 9.3 - - 9.3 - 4.4 - - 4.4 4.9 111.4%
Minastrin(R) 24 - 3.6 - - 3.6 - 84.9 - - 84.9 (81.3) (95.8)%
Enablex(R) - 0.9 - - 0.9 - 1.9 - - 1.9 (1.0) (52.6)%
Namenda(R) IR - - - - - - 2.9 - - 2.9 (2.9) (100.0)%
Other Products Revenues 71.5 169.3 98.4 4.3 343.5 22.7 147.2 89.5 6.8 266.2 77.3 29.0%
Less product sold through our former Anda Distribution business n.a. n.a. n.a. - - n.a. n.a. n.a. (23.7) (23.7) 23.7 n.a.
---- ---- ---- --- --- ---- ---- ---- ----- ----- ---- ----
Total Net Revenues $1,724.8 $1,497.4 $807.8 $4.3 4,034.3 $1,453.2 $1,488.1 $697.8 $(16.9) 3,622.2 $412.1 11.4%
======== ======== ====== ==== ======= ======== ======== ====== ====== ======= ====== ====
** Represents sales of all fillers including Juvederm and Voluma product lines.
Nine Months Ended September 30, 2017 Nine Months Ended September 30, 2016 Movement
------------------------------------ ------------------------------------ --------
US Specialized US General International Corporate Total US Specialized US General International Corporate Total Total Total Change
Therapeutics Medicine Therapeutics Medicine Percentage
Change
------
Botox(R) $1,642.0 $ - $662.6 $ - $2,304.6 $1,454.0 $ - $592.9 $ - $2,046.9 $257.7 12.6%
Restasis(R) 1,012.0 - 46.7 - 1,058.7 1,026.4 - 49.7 - 1,076.1 (17.4) (1.6)%
Juvederm Collection** 361.6 - 386.0 - 747.6 325.3 - 304.2 - 629.5 118.1 18.8%
Linzess(R)/Constella(R) - 506.3 16.1 - 522.4 - 452.0 12.7 - 464.7 57.7 12.4%
Lumigan(R)/Ganfort(R) 236.6 - 271.8 - 508.4 240.4 - 269.2 - 509.6 (1.2) (0.2)%
Bystolic(R) /Byvalson(R) - 454.7 1.6 - 456.3 - 479.0 1.3 - 480.3 (24.0) (5.0)%
Alphagan(R)/Combigan(R) 275.5 - 128.4 - 403.9 274.3 - 127.3 - 401.6 2.3 0.6%
Eye Drops 152.2 - 207.2 - 359.4 140.1 - 206.9 - 347.0 12.4 3.6%
Namenda XR(R) - 355.0 - - 355.0 - 486.5 - - 486.5 (131.5) (27.0)%
Lo Loestrin(R) - 332.8 - - 332.8 - 296.0 - - 296.0 36.8 12.4%
Breast Implants 173.6 - 116.8 - 290.4 149.2 - 112.5 - 261.7 28.7 11.0%
Estrace(R) Cream - 265.1 - - 265.1 - 276.4 - - 276.4 (11.3) (4.1)%
Viibryd(R)/Fetzima(R) - 244.2 2.1 - 246.3 - 252.6 0.1 - 252.7 (6.4) (2.5)%
Alloderm 223.3 - 5.0 - 228.3 - - - - - 228.3 n.a.
Ozurdex (R) 72.0 - 152.5 - 224.5 61.8 - 130.2 - 192.0 32.5 16.9%
Vraylar(TM) - 200.1 - - 200.1 - 51.1 - - 51.1 149.0 n.m.
Asacol(R)/Delzicol(R) - 152.7 36.8 - 189.5 - 297.9 40.5 - 338.4 (148.9) (44.0)%
Carafate (R) /Sulcrate (R) - 176.6 2.1 - 178.7 - 167.7 1.7 - 169.4 9.3 5.5%
Zenpep(R) - 153.8 - - 153.8 - 145.1 - - 145.1 8.7 6.0%
Canasa(R)/Salofalk(R) - 115.7 13.3 - 129.0 - 135.0 13.0 - 148.0 (19.0) (12.8)%
Aczone(R) 128.3 - 0.3 - 128.6 156.1 - - - 156.1 (27.5) (17.6)%
Coolsculpting Consumables 98.2 - 26.3 - 124.5 - - - - - 124.5 n.a.
Armour Thyroid - 117.8 - - 117.8 - 121.8 - - 121.8 (4.0) (3.3)%
Saphris(R) - 117.5 - - 117.5 - 123.6 - - 123.6 (6.1) (4.9)%
Viberzi(R) - 113.7 0.3 - 114.0 - 55.3 - - 55.3 58.7 106.1%
Namzaric(R) - 94.0 - - 94.0 - 38.0 - - 38.0 56.0 147.4%
Teflaro(R) - 92.7 - - 92.7 - 101.9 - - 101.9 (9.2) (9.0)%
Rapaflo(R) 79.9 - 5.5 - 85.4 87.6 - 4.2 - 91.8 (6.4) (7.0)%
Coolsculpting Systems & Add On Applicators 64.1 - 20.4 - 84.5 - - - - - 84.5 n.a.
Savella(R) - 74.3 - - 74.3 - 74.1 - - 74.1 0.2 0.3%
SkinMedica(R) 72.1 - 1.4 - 73.5 81.5 - - - 81.5 (8.0) (9.8)%
Minastrin(R) 24 - 56.1 - - 56.1 - 247.5 1.4 - 248.9 (192.8) (77.5)%
Tazorac(R) 51.3 - 0.5 - 51.8 68.0 - 0.6 - 68.6 (16.8) (24.5)%
Latisse(R) 40.5 - 6.2 - 46.7 54.7 - 6.2 - 60.9 (14.2) (23.3)%
Avycaz(R) - 42.7 - - 42.7 - 26.9 - - 26.9 15.8 58.7%
Kybella(R) /Belkyra(R) 37.4 - 5.1 - 42.5 38.2 - 1.6 - 39.8 2.7 6.8%
Dalvance(R) - 40.9 1.2 - 42.1 - 26.7 - - 26.7 15.4 57.7%
Lexapro(R) - 39.4 - - 39.4 - 50.8 - - 50.8 (11.4) (22.4)%
Liletta(R) - 23.1 - - 23.1 - 15.0 - - 15.0 8.1 54.0%
Enablex(R) - 2.8 - - 2.8 - 14.7 - - 14.7 (11.9) (81.0)%
Namenda(R) IR - 0.1 - - 0.1 - 12.8 - - 12.8 (12.7) (99.2)%
Other Products Revenues 201.2 498.8 287.4 18.3 1,005.7 83.2 442.5 251.9 26.5 804.1 201.6 25.1%
Less product sold through our former Anda Distribution business n.a. n.a. n.a. - - n.a. n.a. n.a. (80.0) (80.0) 80.0 (100.0)%
---- ---- ---- --- --- ---- ---- ---- ----- ----- ---- -------
Total Net Revenues $4,921.8 $4,270.9 $2,403.6 $18.3 11,614.6 $4,240.8 $4,390.9 $2,128.1 $(53.5) 10,706.3 $908.3 8.5%
======== ======== ======== ===== ======== ======== ======== ======== ====== ======== ====== ===
The following table presents Allergan plc's Condensed Consolidated Balance Sheets as of September
30, 2017 and December 31, 2016.
Table 3
ALLERGAN PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited; in millions)
September 30, December 31,
2017 2016
---- ----
Assets
Cash and cash equivalents $1,612.7 $1,724.0
Marketable securities 3,829.1 11,501.5
Accounts receivable, net 2,808.6 2,531.0
Inventories 899.8 718.0
Prepaid expenses and other current assets 962.6 1,383.4
Assets held for sale 11.1 27.0
Property, plant and equipment, net 1,802.2 1,611.3
Investments and other assets 596.9 515.4
Product rights and other intangibles 56,698.9 62,618.6
Goodwill 49,770.9 46,356.1
-------- --------
Total assets $118,992.8 $128,986.3
========== ==========
Liabilities & Equity
Current liabilities $4,762.8 $5,076.8
Current and long-term debt and capital leases 30,336.1 32,768.7
Deferred income taxes and other liabilities 12,720.4 14,940.3
Total equity 71,173.5 76,200.5
-------- --------
Total liabilities and equity $118,992.8 $128,986.3
========== ==========
The following table presents Allergan plc's Condensed Consolidated Statements of Cash Flows for the three and
nine months ended September 30, 2017 and 2016.
Table 4
ALLERGAN PLC
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited; in millions)
Three Months Ended September 30, Nine Months Ended September 30,
-------------------------------- -------------------------------
2017 2016 2017 2016
---- ---- ---- ----
Cash Flows From Operating Activities:
Net (loss) / income $(3,954.0) $15,221.8 $(7,242.1) $14,978.3
--------- --------- --------- ---------
Reconciliation to net cash provided by operating activities:
Depreciation 42.0 40.7 123.2 117.6
Amortization 1,781.0 1,609.1 5,274.9 4,836.7
Provision for inventory reserve 28.6 45.8 77.3 162.7
Share-based compensation 72.3 81.1 220.8 269.9
Deferred income tax benefit (1,726.5) (190.0) (3,205.3) (517.1)
Pre-tax gain on sale of generics business' - (24,203.1) - (24,203.1)
Non-cash tax effect of gain on sale of generics business - 5,749.9 - 5,749.9
In-process research and development impairments 202.0 42.0 1,245.3 316.9
Loss on asset sales and impairments, net 3,874.8 (4.7) 3,896.2 (24.0)
Net income impact of other-than-temporary loss 1,295.5 - 3,273.5 -
on investment in Teva securities
Amortization of inventory step up 38.4 - 126.2 42.4
Non-cash extinguishment of debt - - (8.2) -
Amortization of deferred financing costs 6.4 23.6 19.6 44.6
Contingent consideration adjustments, (66.8) 15.9 (51.6) 76.7
including accretion
Other, net 4.4 10.4 (18.2) (16.0)
Changes in assets and liabilities (net of effects
of acquisitions):
Decrease / (increase) in accounts receivable, net 0.5 460.8 (138.5) (40.4)
Decrease / (increase) in inventories (12.6) (38.4) (107.7) (221.6)
Decrease / (increase) in prepaid expenses 35.3 (86.5) 45.8 158.9
and other current assets
Increase / (decrease) in accounts payable (148.8) (92.1) (356.3) 331.9
and accrued expenses
Increase / (decrease) in income and other (27.6) 346.0 646.1 (131.6)
taxes payable
Increase / (decrease) in other assets and liabilities 27.5 (130.0) 4.0 (397.5)
---- ------ --- ------
Net cash provided by / (used in) operating activities 1,472.4 (1,097.7) 3,825.0 1,535.2
------- -------- ------- -------
Cash Flows From Investing Activities:
Additions to property, plant and equipment (96.8) (67.7) (234.0) (250.5)
Additions to product rights and other intangibles (18.0) - (604.3) -
Sale of generics business - 33,304.5 - 33,304.5
Additions to investments (1,645.9) (15,445.5) (8,433.8) (15,445.5)
Proceeds from sale of investments and other assets 1,276.9 14.5 14,474.4 40.0
Proceeds from sales of property, plant and equipment 1.5 18.8 5.8 33.3
Acquisitions of businesses, net of cash acquired - (74.5) (5,290.4) (74.5)
--- ----- -------- -----
Net cash (used in) / provided by (482.3) 17,750.1 (82.3) 17,607.3
investing activities
Cash Flows From Financing Activities:
Proceeds from borrowings on long-term indebtedness, including credit facility 2.0 150.0 3,025.0 1,050.0
Debt issuance and other financing costs - - (17.5) -
Payments on debt, including capital lease obligations - (6,995.4) (5,579.2) (10,831.0)
Proceeds from stock plans 42.5 30.7 167.2 138.0
Payments of contingent consideration and other financing (10.1) (13.9) (515.2) (77.7)
Repurchase of ordinary shares (1.2) (2,691.3) (36.4) (2,758.6)
Dividends (305.1) (69.6) (917.0) (208.8)
------ ----- ------ ------
Net cash (used in) financing activities (271.9) (9,589.5) (3,873.1) (12,688.1)
------ -------- -------- ---------
Effect of currency exchange rate changes on cash 7.6 2.3 19.1 4.3
and cash equivalents
Net increase / (decrease) in cash and cash equivalents 725.8 7,065.2 (111.3) 6,458.7
Cash and cash equivalents at beginning of period 886.9 489.5 1,724.0 1,096.0
----- ----- ------- -------
Cash and cash equivalents at end of period $1,612.7 $7,554.7 $1,612.7 $7,554.7
======== ======== ======== ========
Non-GAAP performance net income per share is used by management as one of the primary metrics in evaluating the Company's performance. We believe that Non-GAAP performance net income per share enhances the comparability of our results between periods and provides additional information and transparency to investors on adjustments and other items that are not indicative of the Company's current and future operating performance. These are the financial measures used by our management team to evaluate our operating performance and make day to day operating decisions. We define non-GAAP
adjustments to the reported GAAP measures as GAAP results adjusted for the following net of tax: (i) amortization expenses, (ii) global supply chain and operational excellence initiatives, (iii) acquisition, integration and licensing charges, (iv) accretion and fair market value adjustments on contingent liabilities, (v) impairment/asset sales and related costs, including the exclusion of discontinued operations, (vi) legal settlements and (vii) other unusual charges or expenses. Non-GAAP performance net income per share is not, and should not be viewed as, a substitute for reported GAAP
continuing operations loss per share. The Company has consistently excluded amortization of all intangible assets, including the product rights that generate a significant portion of our ongoing revenue. The Company's total accumulated amortization, including impairments of currently marketed products, related to our intangible assets as of September 30, 2017 and December 31, 2016 was $23.9 billion and $14.6 billion, respectively, and is expected to continue to be a material non-GAAP adjustment. The following table presents Allergan plc's GAAP to Non-GAAP adjustments for the three and nine
months ended September 30, 2017 and 2016:
Table 5
ALLERGAN PLC
GAAP TO NON-GAAP ADJUSTMENTS
(Unaudited; in millions)
Three Months Ended September 30, 2017
Net COGS Research & Selling & General & Amortization Asset sales Interest Other Income
Revenue Development Marketing Administrative and expense, income taxes
Impairments, net (expense)
net
GAAP $4,034.3 $586.5 $442.6 $832.8 $336.9 $1,781.0 $4,076.8 $(254.1) $(1,310.3) $(1,638.8)
Impact of selling through purchase accounting mark-up on acquired inventory - (38.4) - - - - - - - -
Purchase accounting impact on stock-based compensation for acquired awards - (1.2) (4.3) (8.1) (3.4) - - - - -
Severance due to integration of acquired entities - - (0.5) (3.2) (2.0) - - - - -
Non-acquisition related severance and restructuring - (39.7) 11.7 5.2 (6.4) - - - - -
Costs associated with disposed businesses - (1.6) - (0.2) (0.3) - - - - -
Integration charges of acquired businesses - - (1.4) 1.3 (21.1) - - - - -
Brand related milestones and upfront expenses for asset acquisitions
Heptares Therapeutics Ltd. - - (15.0) - - - - - - -
Lyndra, Inc. - - (15.0) - - - - - - -
Other - - (12.6) - - - - - - -
Accretion and fair-value adjustments to contingent consideration - 67.0 (0.2) - - - - - - -
Net income impact of determining that the loss on investment of Teva securities is other-than-
temporary - - - - - - - - 1,295.5 -
Non-cash amortization of debt premium recognized in purchase accounting - - - - - - - (6.8) - -
Impairment of Restasis(R) intangible assets and dry eye IPR&D projects acquired in the Allergan
acquisition - - - - - - (3,394.0) - - -
Impairment of Aczone(R) intangible assets - - - - - - (646.0) - - -
Decrease in realization of certain R&D projects acquired in the Warner Chilcott acquisition - - - - - - (21.0) - - -
Impairment of IPR&D products acquired in the Allergan Acquisition - - - - - - (17.0) - - -
Asset sales and impairments, other - - - - - - 1.2 - - -
Litigation settlement related charges - - - - (32.9) - - - - -
Other adjustments - (13.8) - (1.3) 2.3 (1,781.0) - - 0.3 -
Income taxes on pre-tax adjustments - - - - - - - - - 1,856.3
Discrete income tax events - - - - - - - - - 4.3
Non-GAAP Adjusted $4,034.3 $558.8 $405.3 $826.5 $273.1 $ - $ - $(260.9) $(14.5) $221.8
======== ====== ====== ====== ====== === === === === ======= ====== ======
ALLERGAN PLC
GAAP TO NON-GAAP ADJUSTMENTS
(Unaudited; in millions)
Three Months Ended September 30, 2016
Net COGS Research & Selling & General & Amortization Asset sales Interest Other Income
Development Marketing Administrative
Revenue and expense, income taxes
Impairments, net (expense)
net
GAAP $3,622.2 $462.2 $622.8 $796.0 $361.2 $1,609.1 $37.3 $(306.2) $33.6 $(158.9)
Expenditures incurred with the Pfizer transaction - (1.3) (2.2) (5.2) (9.3) - - - - -
Purchase accounting impact on stock-based compensation for acquired awards - (1.7) (8.0) (16.3) (12.0) - - - - -
Severance due to integration of acquired entities and other restructuring programs - (0.3) (4.1) (2.6) (12.4) - - - - -
Integration charges of acquired businesses - (6.4) (2.9) 3.7 (38.5) - - - - -
Brand related milestones and upfront expenses for asset acquisitions
Retrosense Therapeutics, LLC - - (59.7) - - - - - - -
Akarna Therapeutics, Ltd. - - (48.2) - - - - - - -
Merck license agreement - - (100.0) - - - - - - -
Accretion and fair-value adjustments to contingent consideration - (10.4) (5.5) - - - - - - -
Mark-to-market adjustments for foreign currency option contracts - - - - (18.2) - - - - -
Non-cash amortization of debt premium recognized in purchase accounting - - - - - - - (10.3) - -
Abandonment of certain R&D projects acquired in the Forest acquisition - - - - - - (42.0) - - -
Asset sales and impairments, other - - - - - - 4.7 - - -
Litigation settlement related charges - - - - (40.8) - - - - -
Other adjustments - 0.1 (5.8) - 1.3 (1,609.1) - - - -
Income taxes on pre-tax adjustments - - - - - - - - - 147.7
Discrete income tax events - - - - - - - - - 134.5
Non-GAAP Adjusted $3,622.2 $442.2 $386.4 $775.6 $231.3 $ - $ - $(316.5) $33.6 $123.3
======== ====== ====== ====== ====== === === === === ======= ===== ======
The non-GAAP income tax expense is determined based on our pre-tax income adjusted for non-GAAP items on a jurisdiction by jurisdiction basis. The non-GAAP effective tax rate for the three months ended September 30, 2017 was impacted by U.S. income taxed at rates higher than the Irish statutory rate, partially offset by income earned in jurisdictions with tax rates lower than the Irish statutory rate.
The non-GAAP effective tax rate for the three months ended September 30, 2017 excludes a net discrete tax benefit of approximately $4.3 million related to individually insignificant items.
ALLERGAN PLC
GAAP TO NON-GAAP ADJUSTMENTS
(Unaudited; in millions)
Nine Months Ended September 30, 2017
Net COGS Research & Selling & General & Amortization Asset sales Interest Other Income
Revenue Development Marketing Administrative and expense, income taxes
Impairments, net (expense)
net
GAAP $11,614.6 $1,587.1 $1,691.9 $2,637.1 $1,112.8 $5,274.9 $5,141.5 $(779.3) $(3,366.6) $(2,752.1)
Impact of selling through purchase accounting mark-up on acquired inventory - (126.2) - - - - - - - -
Expenditures incurred with the Pfizer transaction - (2.0) (2.4) (5.6) (10.5) - - - - -
Purchase accounting impact on stock-based compensation for acquired awards - (3.3) (14.5) (26.4) (45.8) - - - - -
Severance due to integration of acquired entities - (0.5) (3.0) (18.7) (16.7) - - - - -
Non-acquisition related severance and restructuring - (45.1) (15.1) (24.7) (9.9) - - - - -
Costs associated with disposed businesses - (2.6) - (0.2) (13.7) - - - - -
Integration charges of acquired businesses - (0.6) (2.3) (4.3) (76.1) - - - - -
Brand related milestones and upfront expenses for asset acquisitions
Assembly Biosciences, Inc. - - (50.0) - - - - - - -
Lysosomal Therapeutics, Inc. - - (145.0) - - - - - - -
Editas Medicine Inc. - - (90.0) - - - - - - -
Akarna Therapeutics, Ltd. - - (39.6) - - - - - - -
Heptares Therapeutics Ltd. - - (15.0) - - - - - - -
Lyndra, Inc. - - (15.0) - - - - - - -
Other - - (31.9) - - - - - - -
Accretion and fair-value adjustments to contingent consideration - 127.3 (75.7) - - - - - - -
Net income impact of determining that the loss on investment of Teva securities is other-than-
temporary - - - - - - - - 3,273.5 -
Non-cash amortization of debt premium recognized in purchase accounting - - - - - - - (26.8) - -
Termination of agreement for SER-120 - - - - - - (147.4) - - -
Impairment of Restasis(R) intangible assets and dry eye IPR&D projects acquired in the Allergan
acquisition - - - - - - (3,394.0) - - -
Impairment of Aczone(R) intangible assets - - - - - - (646.0) - - -
Impairment of IPR&D products acquired in the Allergan Acquisition - - - - - - (567.0) - - -
Decrease in realization of certain R&D projects acquired in the Uteron acquisition - - - - - - (91.3) - - -
Decrease in realization of certain R&D projects acquired in the Warner Chilcott acquisition - - - - - - (278.0) - - -
Asset sales and impairments, other - - - - - - (17.8) - - -
Settlement of Naurex, Inc. agreement - - - - - - - - (20.0) -
Impact of debt refinancing - - - - (12.6) - - - 161.5 -
Litigation settlement related charges - - - - (74.3) - - - - -
Other adjustments - (12.5) 0.7 (1.5) 13.1 (5,274.9) - - 6.0 -
Income taxes on pre-tax adjustments - - - - - - - - - 3,150.3
Discrete income tax events - - - - - - - - - 220.7
Non-GAAP Adjusted $11,614.6 $1,521.6 $1,193.1 $2,555.7 $866.3 $ - $ - $(806.1) $54.4 $618.9
========= ======== ======== ======== ====== === === === === ======= ===== ======
ALLERGAN PLC
GAAP TO NON-GAAP ADJUSTMENTS
(Unaudited; in millions)
Nine Months Ended September 30, 2016
Net COGS Research & Selling & General & Amortization Asset sales Interest Other Income
Revenue Development Marketing Administrative and expense, income taxes
Impairments, net (expense)
net
GAAP $10,706.3 $1,381.1 $1,662.4 $2,429.6 $1,033.9 $4,831.9 $292.9 $(979.4) $184.2 $(825.8)
Impact of selling through purchase accounting mark-up on acquired inventory - (42.4) - - - - - - - -
Expenditures incurred with the Pfizer transaction - (3.5) (5.7) (26.2) (57.5) - - - (150.0) -
Purchase accounting impact on stock-based compensation for acquired awards - (6.4) (31.8) (55.3) (35.7) - - - - -
Severance due to integration of acquired entities and other restructuring programs - (3.6) (6.7) (8.0) (17.8) - - - - -
Integration charges of acquired businesses - (8.9) 3.4 (3.7) (121.5) - - - - -
Brand related milestones and upfront expenses for asset acquisitions
Topokine Therapeutics, Inc. - - (85.8) - - - - - - -
Anterios, Inc. - - (89.2) - - - - - - -
Retrosense Therapeutics, LLC - - (59.7) - - - - - - -
Akarna Therapeutics, Ltd. - - (48.2) - - - - - - -
Merck license agreement - - (100.0) - - - - - - -
Heptares Therapeutics Ltd. - - (125.0) - - - - - - -
Other - - (34.2) - - - - - - -
Accretion and fair-value adjustments to contingent consideration - (13.4) (65.8) - (0.1) - - - - -
Mark-to-market adjustments for foreign currency option contracts - - - - (18.4) - - - - -
Non-cash amortization of debt premium recognized in purchase accounting - - - - - - - (40.6) - -
Women's healthcare portfolio product impairment - - - - - - (24.0) - - -
Abandonment of certain R&D projects acquired in the Allergan acquisition - - - - - - (189.9) - - -
Abandonment of certain R&D projects acquired in the Forest acquisition - - - - - - (42.0) - - -
Asset sales and impairments, other - - - - - - (37.0) - - -
Litigation settlement related charges - - - - (100.0) - - - - -
Other adjustments - - (5.8) (0.1) (4.5) (4,831.9) - - - -
Income taxes on pre-tax adjustments - - - - - - - - - 1,127.8
Discrete income tax events - - - - - - - - - 62.2
Non-GAAP Adjusted $10,706.3 $1,302.9 $1,007.9 $2,336.3 $678.4 $ - $ - $(1,020.0) $34.2 $364.2
========= ======== ======== ======== ====== === === === === ========= ===== ======
The non-GAAP income tax expense is determined based on our pre-tax income adjusted for non-GAAP items on a jurisdiction by jurisdiction basis. The non-GAAP effective tax rate for the nine months ended September 30, 2017 was impacted by U.S. income taxed at rates higher than the Irish statutory rate, partially offset by income earned in jurisdictions with tax rates lower than the Irish statutory rate.
The non-GAAP effective tax rate for the nine months ended September 30, 2017 excludes a net discrete tax benefit of approximately $220.7 million related to the tax effects of an investment in a U.S. subsidiary, integration activities and other individually insignificant items.
The following table presents a reconciliation of Allergan plc's reported net (loss) from continuing operations attributable to shareholders and diluted earnings per share to non-GAAP performance net income and non-GAAP performance net income per share for the three and nine months ended September 30, 2017 and 2016:
Table 6
ALLERGAN PLC
RECONCILIATION TABLE
(Unaudited; in millions except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2017 2016 2017 2016
---- ---- ---- ----
GAAP to Non-GAAP Performance net income calculation
GAAP (loss) from continuing operations attributable to $(3,949.6) $(381.9) $(7,229.2) $(899.2)
shareholders
Adjusted for:
Amortization 1,781.0 1,609.1 5,274.9 4,831.9
Acquisition and licensing charges (1) 1,404.5 321.5 4,036.1 793.2
Accretion and fair-value adjustments to contingent (66.8) 15.9 (51.6) 79.3
consideration
Impairment/asset sales and related costs 4,076.8 37.3 5,141.5 292.9
Non-recurring (gain) / losses 13.8 18.2 187.9 18.4
Global supply chain initiatives 39.7 - 39.7 -
Legal settlements 32.9 40.8 74.3 100.0
Income taxes on items above and other income (1,860.6) (282.2) (3,371.0) (1,190.0)
tax adjustments
Non-GAAP performance net income attributable to $1,471.7 $1,378.7 $4,102.6 $4,026.5
shareholders
Diluted earnings per share
Diluted (loss) per share from continuing operations $(11.84) $(0.97) $(21.61) $(2.28)
attributable to
shareholders- GAAP
Non-GAAP performance net income per share $4.15 $3.32 $11.51 $9.66
attributable to shareholders
Basic weighted average ordinary shares outstanding 333.5 392.7 334.6 394.4
Effect of dilutive securities:
Dilutive shares 21.4 22.0 21.9 22.3
---- ---- ---- ----
Diluted weighted average ordinary shares outstanding 354.9 414.7 356.5 416.7
===== ===== ===== =====
(1) Includes stock-based compensation primarily due to the Zeltiq, Allergan and Forest acquisitions as well as the valuation accounting impact in interest expense, net.
We define adjusted EBITDA as an amount equal to consolidated net income /(loss) from continuing operations attributable to shareholders for such period adjusted for the following: (i) interest expense, (ii) interest income, (iii) (benefit) for income taxes, (iv) depreciation and amortization expenses, (v)
stock-based compensation expense, (vi) asset impairment charges and losses /(gains) and expenses associated with the sale of assets, including the exclusion of discontinued operations, (vii) business restructuring charges associated with Allergan's global supply chain and operational excellence initiatives
or other restructurings of a similar nature, (viii) costs and charges associated with the acquisition of businesses and assets including, but not limited to, milestone payments, integration charges, other charges associated with the revaluation of assets or liabilities and charges associated with the
revaluation of acquisition related contingent liabilities that are based in whole or in part on future estimated cash flows, (ix) litigation charges and settlements and (x) other unusual charges or expenses. We define non-GAAP adjusted operating income as adjusted EBITDA including depreciation and certain
stock-based compensation charges and excluding dividend income and other-than-temporary investment impairments included within other income (expense), net.
The following table presents a reconciliation of Allergan plc's reported net (loss) from continuing operations attributable to shareholders for the three and nine months ended September 30, 2017 and 2016 to adjusted EBITDA and adjusted operating income:
Table 7
ALLERGAN PLC
ADJUSTED EBITDA and ADJUSTED OPERATING INCOME, RECONCILIATION TABLE
(Unaudited; in millions)
Three Months Ended Nine Months Ended
September 30, September 30,
------------- -------------
2017 2016 2017 2016
---- ---- ---- ----
GAAP (loss) from continuing operations attributable to $(3,949.6) $(381.9) $(7,229.2) $(899.2)
shareholders
Plus:
Interest expense 265.2 324.3 832.3 1,002.9
Interest income (11.1) (18.1) (53.0) (23.5)
(Benefit) for income taxes (1,638.8) (158.9) (2,752.1) (825.8)
Depreciation 42.0 40.7 123.2 114.5
Amortization 1,781.0 1,609.1 5,274.9 4,831.9
------- ------- ------- -------
EBITDA $(3,511.3) $1,415.2 $(3,803.9) $4,200.8
--------- -------- --------- --------
Adjusted for:
Acquisition and licensing and other charges 1,394.3 293.8 3,972.9 704.6
Impairment/asset sales and related costs 4,076.8 37.3 5,141.5 292.9
Non-recurring (gain) / losses 13.8 18.2 187.9 18.4
Global supply chain initiatives 39.7 - 39.7 -
Legal settlements 32.9 40.8 74.3 100.0
Accretion and fair-value adjustments to contingent (66.8) 15.9 (51.6) 79.3
consideration
Share-based compensation including cash settlements 72.3 81.0 252.3 257.0
---- ---- ----- -----
Adjusted EBITDA $2,051.7 $1,902.2 $5,813.1 $5,653.0
-------- -------- -------- --------
Adjusted for:
Depreciation (42.0) (40.7) (123.2) (114.5)
Dividend income (8.5) (34.1) (76.7) (34.1)
Other-than-temporary security impairments 22.3 - 22.3 -
Share-based compensation not related to (55.3) (43.0) (162.3) (127.8)
restructuring charges and purchase accounting
impact on stock-based compensation for acquired
awards
Adjusted Operating Income $1,968.2 $1,784.4 $5,473.2 $5,376.6
======== ======== ======== ========
The following table details Allergan plc's segment contribution reconciled to the non-GAAP contribution for the same financial statement line items for the three and nine months ended September 30, 2017 and 2016.
Table 8
ALLERGAN PLC
Segment Contribution to Non-GAAP Allergan plc Contribution
(Unaudited; $ in millions)
Three Months Ended September 30, 2017 Three Months Ended September 30, 2016
------------------------------------- -------------------------------------
US Specialized US General International Corporate Total Company US US General International Corporate Total
Specialized Company
Therapeutics Medicine Segment Medicine Segment
Segment Therapeutics Segment
Segment
Segment
Net revenues (1) $1,724.8 $1,497.4 $807.8 $4.3 $4,034.3 $1,453.2 $1,488.1 $697.8 $(16.9) $3,622.2
-------- -------- ------ ---- -------- -------- -------- ------ ------ --------
Operating expenses:
Cost of sales(1)(2) 131.4 225.5 116.3 85.6 558.8 69.2 215.1 95.1 62.8 442.2
Selling and marketing 353.5 247.7 224.8 0.5 826.5 292.4 292.8 188.2 2.2 775.6
General and administrative 54.8 47.7 28.3 142.3 273.1 41.2 42.3 28.0 119.8 231.3
---- ---- ---- ----- ----- ---- ---- ---- ----- -----
Segment contribution $1,185.1 $976.5 $438.4 $(224.1) $2,375.9 $1,050.4 $937.9 $386.5 $(201.7) $2,173.1
======== ====== ====== ======= ======== ======== ====== ====== ======= ========
Segment margin 68.7% 65.2% 54.3% n.m. 58.9% 72.3% 63.0% 55.4% n.m. 60.0%
Segment gross margin(3) 92.4% 84.9% 85.6% n.m. 86.1% 95.2% 85.5% 86.4% n.m. 87.8%
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers for the US Specialized Therapeutics Segment and the US General Medicine Segment in the three months ended September 30, 2016 of $23.7 million, which are reclassified to discontinued operations through Corporate. The corresponding reclassification recorded in cost of goods sold was $23.0 million in the three months ended September 30, 2016.
(2) Excludes amortization and impairment of acquired intangibles including product rights.
(3) Defined as net revenues less segment related cost of sales as a percentage of net revenues.
Nine Months Ended September 30, 2017 Nine Months Ended September 30, 2016
------------------------------------ ------------------------------------
US Specialized US General International Corporate Total Company US US General International Corporate Total
Therapeutics Medicine Segment Specialized Medicine Segment Company
Segment Segment Therapeutics Segment
Segment
-------
Net revenues (1) $4,921.8 $4,270.9 $2,403.6 $18.3 $11,614.6 $4,240.8 $4,390.9 $2,128.1 $(53.5) $10,706.3
-------- -------- -------- ----- --------- -------- -------- -------- ------ ---------
Operating expenses:
Cost of sales(1)(2) 349.4 623.2 341.6 207.4 1,521.6 215.0 649.6 309.3 129.0 1,302.9
Selling and marketing 1,040.7 838.3 673.2 3.5 2,555.7 844.8 902.8 582.7 6.0 2,336.3
General and administrative 149.4 129.7 86.5 500.7 866.3 126.4 128.2 86.5 337.3 678.4
----- ----- ---- ----- ----- ----- ----- ---- ----- -----
Segment contribution $3,382.3 $2,679.7 $1,302.3 $(693.3) $6,671.0 $3,054.6 $2,710.3 $1,149.6 $(525.8) $6,388.7
======== ======== ======== ======= ======== ======== ======== ======== ======= ========
Segment margin 68.7% 62.7% 54.2% n.m. 57.4% 72.0% 61.7% 54.0% n.m. 59.7%
Segment gross margin(3) 92.9% 85.4% 85.8% n.m. 86.9% 94.9% 85.2% 85.5% n.m. 87.8%
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers for the US Specialized Therapeutics Segment and the US General Medicine Segment in the nine months ended September 30, 2016 of $80.0 million, which are reclassified to discontinued operations through Corporate. The corresponding reclassification recorded in cost of goods sold was $78.2 million in the nine months ended September 30, 2016.
(2) Excludes amortization and impairment of acquired intangibles including product rights.
(3) Defined as net revenues less segment related cost of sales as a percentage of net revenues.
The following table details Allergan plc's product revenue for significant promoted products within the US Specialized Therapeutics segment for the three and nine months ended September 30, 2017 and 2016.
Table 9
ALLERGAN PLC
US Specialized Therapeutics Product Revenue
(Unaudited; in millions)
Three Months Change
Ended September 30,
-------------------
2017 2016 (1) Dollars %
---- ------- ------- ---
Total Eye Care $635.3 $608.5 $26.8 4.4%
Restasis(R) 366.8 356.4 10.4 2.9%
Alphagan(R)/Combigan(R) 92.7 93.4 (0.7) (0.7)%
Lumigan(R)/Ganfort(R) 83.3 78.3 5.0 6.4%
Ozurdex(R) 24.6 20.9 3.7 17.7%
Eye Drops 53.7 50.2 3.5 7.0%
Other Eye Care 14.2 9.3 4.9 52.7%
Total Medical Aesthetics 602.3 388.9 213.4 54.9%
Facial Aesthetics 314.9 293.7 21.2 7.2%
Botox(R) Cosmetics 189.7 174.5 15.2 8.7%
Juvederm Collection 115.6 105.0 10.6 10.1%
Kybella(R) 9.6 14.2 (4.6) (32.4)%
Plastic Surgery 58.0 52.2 5.8 11.1%
Breast Implants 58.0 51.1 6.9 13.5%
Other Plastic Surgery - 1.1 (1.1) (100.0)%
Regenerative Medicine 113.7 - 113.7 n.a.
Alloderm(R) 84.6 - 84.6 n.a.
Other Regenerative Medicine 29.1 - 29.1 n.a.
Body Contouring 83.4 - 83.4 n.a.
Coolsculpting(R) Systems & Add On Applicators 33.1 - 33.1 n.a.
Coolsculpting(R) Consumables 50.3 - 50.3 n.a.
Skin Care 32.3 43.0 (10.7) (24.9)%
SkinMedica(R) 18.7 25.8 (7.1) (27.5)%
Latisse(R) 13.6 17.2 (3.6) (20.9)%
Total Medical Dermatology 86.9 116.1 (29.2) (25.2)%
Aczone(R) 46.7 69.0 (22.3) (32.3)%
Tazorac(R) 15.1 27.5 (12.4) (45.1)%
Botox(R) Hyperhidrosis 16.8 16.3 0.5 3.1%
Other Medical Dermatology 8.3 3.3 5.0 151.5%
Total Neuroscience & Urology 380.4 330.7 49.7 15.0%
Botox(R) Therapeutics 352.1 305.5 46.6 15.3%
Rapaflo(R) 28.3 25.2 3.1 12.3%
Other Neuroscience & Urology - - - n.a.
Other Revenues 19.9 9.0 10.9 121.1%
---- --- ---- -----
Net revenues $1,724.8 $1,453.2 $271.6 18.7%
======== ======== ====== ====
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers.
Nine Months Change
Ended September 30,
-------------------
2017 2016 (1) Dollars %
---- ------- ------- ---
Total Eye Care $1,788.5 $1,777.6 $10.9 0.6%
Restasis(R) 1,012.0 1,026.4 (14.4) (1.4)%
Alphagan(R)/Combigan(R) 275.5 274.3 1.2 0.4%
Lumigan(R)/Ganfort(R) 236.6 240.4 (3.8) (1.6)%
Ozurdex(R) 72.0 61.8 10.2 16.5%
Eye Drops 152.2 140.1 12.1 8.6%
Other Eye Care 40.2 34.6 5.6 16.2%
Total Medical Aesthetics 1,736.3 1,182.6 553.7 46.8%
Facial Aesthetics 982.8 893.3 89.5 10.0%
Botox(R) Cosmetics 583.8 529.8 54.0 10.2%
Fillers 361.6 325.3 36.3 11.2%
Kybella(R) 37.4 38.2 (0.8) (2.1)%
Plastic Surgery 173.6 153.1 20.5 13.4%
Breast Implants 173.6 149.2 24.4 16.4%
Other Plastic Surgery - 3.9 (3.9) (100.0)%
Regenerative Medicine 305.0 - 305.0 n.a.
Alloderm(R) 223.3 - 223.3 n.a.
Other Regenerative Medicine 81.7 - 81.7 n.a.
Body Contouring 162.3 - 162.3 n.a.
Coolsculpting(R) Systems & Add On Applicators 64.1 - 64.1 n.a.
Coolsculpting(R) Consumables 98.2 - 98.2 n.a.
Skin Care 112.6 136.2 (23.6) (17.3)%
SkinMedica(R) 72.1 81.5 (9.4) (11.5)%
Latisse(R) 40.5 54.7 (14.2) (26.0)%
Total Medical Dermatology 255.3 282.2 (26.9) (9.5)%
Aczone(R) 128.3 156.1 (27.8) (17.8)%
Tazorac(R) 51.3 68.0 (16.7) (24.6)%
Botox(R) Hyperhidrosis 50.4 48.9 1.5 3.1%
Other Medical Dermatology 25.3 9.2 16.1 175.0%
Total Neuroscience & Urology 1,087.7 963.8 123.9 12.9%
Botox(R) Therapeutics 1,007.8 875.3 132.5 15.1%
Rapaflo(R) 79.9 87.6 (7.7) (8.8)%
Other Neuroscience & Urology - 0.9 (0.9) (100.0)%
Other Revenues 54.0 34.6 19.4 56.1%
---- ---- ---- ----
Net revenues $4,921.8 $4,240.8 $681.0 16.1%
======== ======== ====== ====
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers.
The following table details Allergan plc's product revenue for significant promoted products within the US General Medicine segment for the three and nine months ended September 30, 2017 and 2016.
Table 10
ALLERGAN PLC
US General Medicine Product Revenue
(Unaudited; in millions)
Three Months Change
Ended September 30,
-------------------
2017 2016 (1) Dollars %
---- ------- ------- ---
Total Central Nervous System (CNS) $355.2 $325.5 29.7 9.1%
Namenda XR(R) 114.3 146.9 (32.6) (22.2)%
Namzaric(R) 37.0 14.9 22.1 148.3%
Viibryd(R)/Fetzima(R) 86.5 87.6 (1.1) (1.3)%
Vraylar(TM) 80.2 32.4 47.8 147.5%
Saphris(R) 37.2 40.8 (3.6) (8.8)%
Namenda(R) IR - 2.9 (2.9) (100.0)%
Total Gastrointestinal (GI) 443.5 431.4 12.1 2.8%
Linzess(R) 190.9 164.4 26.5 16.1%
Asacol(R)/Delzicol(R) 49.5 72.2 (22.7) (31.4)%
Carafate(R)/Sulcrate(R) 58.7 56.4 2.3 4.1%
Zenpep(R) 56.8 52.5 4.3 8.2%
Canasa(R)/Salofalk(R) 39.0 47.2 (8.2) (17.4)%
Viberzi(R) 40.9 30.9 10.0 32.4%
Other GI 7.7 7.8 (0.1) (1.3)%
Total Women's Health 265.7 305.3 (39.6) (13.0)%
Lo Loestrin(R) 120.0 105.7 14.3 13.5%
Estrace(R) Cream 101.6 98.6 3.0 3.0%
Minastrin(R) 24 3.6 84.9 (81.3) (95.8)%
Liletta(R) 9.3 4.4 4.9 111.4%
Other Women's Health 31.2 11.7 19.5 166.7%
Total Anti-Infectives 67.2 52.5 14.7 28.0%
Teflaro(R) 29.1 33.3 (4.2) (12.6)%
Dalvance(R) 16.1 10.3 5.8 56.3%
Avycaz(R) 16.9 4.8 12.1 n.m.
Other Anti-Infectives 5.1 4.1 1.0 24.4%
Diversified Brands 318.7 319.3 (0.6) (0.2)%
Bystolic(R) /Byvalson(R) 164.2 165.1 (0.9) (0.5)%
Armour Thyroid 38.5 39.1 (0.6) (1.5)%
Savella(R) 24.0 28.1 (4.1) (14.6)%
Lexapro(R) 12.9 15.6 (2.7) (17.3)%
Enablex(R) 0.9 1.9 (1.0) (52.6)%
PacPharma 3.0 6.2 (3.2) (51.6)%
Other Diversified Brands 75.2 63.3 11.9 18.8%
Other Revenues 47.1 54.1 (7.0) (12.9)%
---- ---- ---- ------
Net revenues $1,497.4 $1,488.1 $9.3 0.6%
======== ======== ==== ===
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers.
Nine Months Change
Ended September 30,
-------------------
2017 2016 (1) Dollars %
---- ------- ------- ---
Total Central Nervous System (CNS) $1,010.9 $964.6 46.3 4.8%
Namenda XR(R) 355.0 486.5 (131.5) (27.0)%
Namzaric(R) 94.0 38.0 56.0 147.4%
Viibryd(R)/Fetzima(R) 244.2 252.6 (8.4) (3.3)%
Saphris(R) 117.5 123.6 (6.1) (4.9)%
Vraylar(TM) 200.1 51.1 149.0 n.m.
Namenda(R) IR 0.1 12.8 (12.7) (99.2)%
Total Gastrointestinal (GI) 1,241.8 1,277.0 (35.2) (2.8)%
Linzess(R) 506.3 452.0 54.3 12.0%
Asacol(R)/Delzicol(R) 152.7 297.9 (145.2) (48.7)%
Carafate(R)/Sulcrate(R) 176.6 167.7 8.9 5.3%
Zenpep(R) 153.8 145.1 8.7 6.0%
Canasa(R)/Salofalk(R) 115.7 135.0 (19.3) (14.3)%
Viberzi(R) 113.7 55.3 58.4 105.6%
Other GI 23.0 24.0 (1.0) (4.2)%
Total Women's Health 758.4 865.1 (106.7) (12.3)%
Lo Loestrin(R) 332.8 296.0 36.8 12.4%
Estrace(R) Cream 265.1 276.4 (11.3) (4.1)%
Minastrin(R) 24 56.1 247.5 (191.4) (77.3)%
Liletta(R) 23.1 15.0 8.1 54.0%
Other Women's Health 81.3 30.2 51.1 169.2%
Total Anti-Infectives 190.7 167.1 23.6 14.1%
Teflaro(R) 92.7 101.9 (9.2) (9.0)%
Dalvance(R) 40.9 26.7 14.2 53.2%
Avycaz(R) 42.7 26.9 15.8 58.7%
Other Anti-Infectives 14.4 11.6 2.8 24.1%
Diversified Brands 923.2 1,038.8 (115.6) (11.1)%
Bystolic(R) /Byvalson(R) 454.7 479.0 (24.3) (5.1)%
Armour Thyroid 117.8 121.8 (4.0) (3.3)%
Savella(R) 74.3 74.1 0.2 0.3%
Lexapro(R) 39.4 50.8 (11.4) (22.4)%
Enablex(R) 2.8 14.7 (11.9) (81.0)%
PacPharma 9.7 49.7 (40.0) (80.5)%
Other Diversified Brands 224.5 248.7 (24.2) (9.7)%
Other Revenues 145.9 78.3 67.6 86.3%
----- ---- ---- ----
Net revenues $4,270.9 $4,390.9 $(120.0) (2.7)%
======== ======== ======= =====
(1) Includes revenues earned that were distributed through our former Anda Distribution business to third party customers.
The following table details Allergan plc's product revenue for significant promoted products within the International segment for the three and nine months ended September 30, 2017 and 2016.
Table 11
ALLERGAN PLC
International Product Revenue
(Unaudited; in millions)
Three Months Change
Ended September 30,
-------------------
2017 2016 Dollars %
---- ---- ------- ---
Total Eye Care $317.9 $294.2 $23.7 8.1%
Lumigan(R)/Ganfort(R) 91.5 86.6 4.9 5.7%
Alphagan(R)/Combigan(R) 43.4 41.3 2.1 5.1%
Ozurdex(R) 50.2 43.4 6.8 15.7%
Optive(R) 28.4 25.6 2.8 10.9%
Other Eye Drops 42.8 42.1 0.7 1.7%
Restasis(R) 15.5 15.4 0.1 0.6%
Other Eye Care 46.1 39.8 6.3 15.8%
Total Medical Aesthetics 331.1 251.0 80.1 31.9%
Facial Aesthetics 259.6 212.6 47.0 22.1%
Botox(R) Cosmetics 131.5 115.3 16.2 14.1%
Juvederm Collection 126.5 96.8 29.7 30.7%
Belkyra(R) (Kybella(R)) 1.6 0.5 1.1 n.m.
Plastic Surgery 38.5 35.8 2.7 7.5%
Breast Implants 38.1 35.6 2.5 7.0%
Earfold(TM) 0.4 0.2 0.2 100.0%
Regenerative Medicine 5.1 - 5.1 n.a.
Alloderm(R) 1.5 - 1.5 n.a.
Other Regenerative Medicine 3.6 - 3.6 n.a.
Body Contouring 24.0 - 24.0 n.a.
Coolsculpting(R) Systems & Add On Applicators 10.2 - 10.2 n.a.
Coolsculpting(R) Consumables 13.8 - 13.8 n.a.
Skin Care 3.9 2.6 1.3 50.0%
Botox(R) Therapeutics and Other 141.8 134.6 7.2 5.3%
Botox(R) Therapeutics 84.4 78.1 6.3 8.1%
Asacol(R)/Delzicol(R) 11.9 14.2 (2.3) (16.2)%
Constella(R) 5.7 4.3 1.4 32.6%
Other Products 39.8 38.0 1.8 4.7%
Other Revenues 17.0 18.0 (1.0) (5.6)%
---- ---- ---- -----
Net revenues $807.8 $697.8 $110.0 15.8%
====== ====== ====== ====
Nine Months Change
Ended September 30,
-------------------
2017 2016 Dollars %
---- ---- ------- ---
Total Eye Care $939.4 $904.4 $35.0 3.9%
Lumigan(R)/Ganfort(R) 271.8 269.2 2.6 1.0%
Alphagan(R)/Combigan(R) 128.4 127.3 1.1 0.9%
Ozurdex(R) 152.5 130.2 22.3 17.1%
Optive(R) 83.5 75.7 7.8 10.3%
Other Eye Drops 123.7 131.2 (7.5) (5.7)%
Restasis(R) 46.7 49.7 (3.0) (6.0)%
Other Eye Care 132.8 121.1 11.7 9.7%
Total Medical Aesthetics 977.3 780.0 197.3 25.3%
Facial Aesthetics 793.1 658.7 134.4 20.4%
Botox(R) Cosmetics 402.0 352.9 49.1 13.9%
Fillers 386.0 304.2 81.8 26.9%
Belkyra(R) (Kybella(R)) 5.1 1.6 3.5 n.m.
Plastic Surgery 118.0 112.9 5.1 4.5%
Breast Implants 116.8 112.5 4.3 3.8%
Earfold(TM) 1.2 0.4 0.8 200.0%
Regenerative Medicine 10.7 - 10.7 n.a.
Alloderm(R) 5.0 - 5.0 n.a.
Other Regenerative Medicine 5.7 - 5.7 n.a.
Body Contouring 46.7 - 46.7 n.a.
Coolsculpting(R) Systems & Add On Applicators 20.4 - 20.4 n.a.
Coolsculpting(R) Consumables 26.3 - 26.3 n.a.
Skin Care 8.8 8.4 0.4 4.8%
Botox(R) Therapeutics and Other 426.8 399.0 27.8 7.0%
Botox(R) Therapeutics 260.6 240.0 20.6 8.6%
Asacol(R)/Delzicol(R) 36.8 40.5 (3.7) (9.1)%
Constella(R) 16.1 12.7 3.4 26.8%
Other Products 113.3 105.8 7.5 7.1%
Other Revenues 60.1 44.7 15.4 34.5%
---- ---- ---- ----
Net revenues $2,403.6 $2,128.1 $275.5 12.9%
======== ======== ====== ====
The following table provides a reconciliation of anticipated GAAP loss from continuing operations to non-GAAP performance net income attributable to shareholders for the year ending December 31, 2017:
Table 12
(in millions, except per share information) LOW HIGH
--- ----
GAAP (loss) from continuing operations attributable to shareholders $(6,520.0) $(6,420.0)
Adjusted for:
Amortization 7,200.0 7,200.0
Acquisition, licensing and other non-recurring charges 4,130.0 4,130.0
Accretion and fair-value adjustments to contingent
consideration (45.0) (45.0)
Impairment/asset sales and related costs 5,150.0 5,150.0
Non-recurring (gains) / losses 200.0 200.0
Global Supply Chain Initiatives 40.0 40.0
Legal settlements 75.0 75.0
Income taxes on items above and other income tax
adjustments (4,480.0) (4,475.0)
-------- --------
Non-GAAP performance net income attributable to shareholders 5,750.0 5,855.0
======= =======
Diluted earnings per share
Diluted (loss) per share from continuing operations attributable to
shareholders- GAAP $(19.52) $(19.22)
======= =======
Non-GAAP performance diluted net income per share attributable to
shareholders $16.15 $16.45
====== ======
Basic weighted average ordinary shares outstanding 334.0 334.0
Effect of dilutive securities:
Dilutive shares 22.0 22.0
---- ----
Diluted weighted average ordinary shares outstanding 356.0 356.0
===== =====
CONTACTS:
Allergan:
Investors:
Daphne Karydas
(862) 261-8006
Media:
Mark Marmur
(862) 261-7558
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SOURCE Allergan plc
