Logo - ttp://photos.prnewswire.com/p...
For the first quarter 2015, adjusted EBITDA increased 107 percent to
First quarter 2015 results for
"
"Our first quarter performance was highlighted by strong revenue growth from Namenda XR®, Linzess®, Bystolic®, Viibryd®/ Fetzima®, LoLoestrin® Fe, Saphris®, Estrace® Cream as well as continued growth within our generics business, powered by strong sales of the generic versions of Concerta®, Intuniv® and the recent launch of our generic version of OxyContin®.
"In the midst of planning for the integration, legacy Allergan delivered pro forma net sales growth of 13 percent on constant currency to approximately
"We have already achieved many of our early integration milestones, including realignment of our global sales organization and notifying 95 percent of our colleagues about their role in the combined company. We are on track to achieve approximately 80 percent of the forecasted
Allergan Business Results
Results from the acquisition of Allergan were included as of the close of the acquisition of
First Quarter 2015 Business Segment Results |
|||||||
North America Brands Segment Information |
|||||||
($ in millions) |
|||||||
Three Months Ended |
|||||||
March 31, |
|||||||
2015 |
2014 |
||||||
Product sales |
$ 1,720.3 |
$ 572.0 |
|||||
Other revenue |
15.7 |
22.0 |
|||||
Net revenues |
1,736.0 |
594.0 |
|||||
Operating expenses: |
|||||||
Cost of sales(1) |
372.0 |
185.5 |
|||||
Selling and marketing |
411.1 |
87.6 |
|||||
General and administrative |
281.8 |
71.5 |
|||||
Segment contribution |
$ 671.1 |
$ 249.4 |
|||||
Segment margin |
38.7% |
42.0% |
|||||
Adjusted gross profit (2) |
$ 1,502.8 |
$ 522.1 |
|||||
Adjusted gross margin as a percentage of adjusted net revenues (2) |
86.6% |
87.9% |
|||||
Adjusted SG&A percentage of adjusted net revenues (3) |
27.8% |
23.0% |
|||||
(1) Cost of sales excludes amortization and impairment of acquired intangibles. |
|||||||
(2) Refer to Table 8 included in this release for the reconciliation of net revenues and cost of sales to adjusted gross profit and |
|||||||
(3) Refer to Table 9 included in this release for the reconciliation of net revenues and SG&A to adjusted SG&A as a |
North American Brands net revenue increased 192 percent to
North American Brands selling and marketing expenses increased to
North American Brands adjusted gross margin for the first quarter 2015 was 86.6 percent, compared to 87.9 percent in the first quarter of 2014. The decrease is largely due to product mix related to the addition of partnered products from the Forest portfolio, including Namenda® and Linzess®.
North America Generics and International Segment Information |
||||||||
($ in millions) |
||||||||
Three Months Ended |
||||||||
March 31, |
||||||||
2015 |
2014 |
|||||||
Product sales |
$ 1,756.4 |
$ 1,634.7 |
||||||
Other revenue |
21.8 |
36.2 |
||||||
Net revenues |
1,778.2 |
1,670.9 |
||||||
Operating expenses: |
||||||||
Cost of sales(1) |
826.8 |
776.3 |
||||||
Selling and marketing |
174.5 |
170.0 |
||||||
General and administrative |
118.1 |
195.0 |
||||||
Segment contribution |
$ 658.8 |
$ 529.6 |
||||||
Segment margin |
37.0% |
31.7% |
||||||
Adjusted gross profit (2) |
$ 1,045.5 |
$ 884.1 |
||||||
Adjusted gross margin as a percentage of adjusted net revenues (2) |
59.9% |
56.7% |
||||||
Adjusted SG&A percentage of adjusted net revenues (3) |
14.8% |
20.3% |
||||||
(1) Cost of sales excludes amortization and impairment of acquired intangibles. |
||||||||
(2) Refer to Table 8 included in this release for the reconciliation of net revenues and cost of sales to adjusted gross profit and |
||||||||
(3) Refer to Table 9 included in this release for the reconciliation of net revenues and SG&A to adjusted SG&A as a |
North American Generics & International net revenue increased 6.4 percent to
Adjusted selling, general and administrative expenses (SG&A) as a percentage of net revenue declined to 14.8 percent for North American Generics and International in the first quarter of 2015 as a result of the divestiture of Western European assets and the elimination of the supportive corporate infrastructure for these assets.
North American Generics & International adjusted gross margin increased to 59.9 percent in the first quarter of 2015 from 56.7 percent in the first quarter of 2014, primarily as a result of strong base business trends and product mix as well as margin expansion within our international business.
Anda Distribution Segment Information |
||||||||
($ in millions) |
||||||||
Three Months Ended |
||||||||
March 31, |
||||||||
2015 |
2014 |
|||||||
Net revenues |
$ 461.6 |
$ 390.2 |
||||||
Operating expenses: |
||||||||
Cost of sales |
404.0 |
331.2 |
||||||
Selling and marketing |
31.4 |
25.5 |
||||||
General and |
9.1 |
9.3 |
||||||
Segment contribution |
$ 17.1 |
$ 24.2 |
||||||
Segment margin |
3.7% |
6.2% |
||||||
Gross profit |
$ 57.6 |
$ 59.0 |
||||||
Gross margin |
12.5% |
15.1% |
||||||
SG&A as a percentage of net revenues |
8.8% |
8.9% |
Anda Distribution net revenue for the first quarter 2015 increased 18 percent to
Anda Distribution segment gross margin was 12.5 percent in the first quarter of 2015 compared to 15.1 percent in the prior year period as a result of business mix.
Other Operating Expenses
In first quarter 2015, consolidated GAAP SG&A expenses were
Amortization expense for the first quarter 2015 was
Pipeline Update
Following the completion of the Allergan acquisition,
The Company plans to continue to evaluate timing of these opportunities and will provide additional details at a later date. R&D productivity continued during the quarter with progress on many key pipeline programs.
North American Brands - NDA/sNDA Approvals
-
Actavis and Medicines360 announced that Liletta® (levonorgesterel-releasing intrauterine system) receivedFDA approval for use by women to prevent pregnancy for up to three years. This groundbreaking partnership allows women access to a new contraceptive option regardless of income or insurance coverage. -
AVYCAZ® (ceftazidime-avibactam) received
FDA approval for the treatment of adult patients with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible bacteria. The approval of AVYCAZ® is an important step forward in providing healthcare providers in the U.S. with a new treatment for serious Gram-negative infections. -
Viibryd® (vilazodone HCl) sNDA received
FDA approval for a lower therapeutic dose of the drug (20mg) to accompany the currently available 40mg dose for the treatment of adult patients with major depressive disorder (MDD). The U.S. approval expands dosing options available to health care providers. -
Saphris® (asenapine) sNDA received
FDA approval for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients. Saphris® is the only atypical antipsychotic treatment option with a sublingual formulation. -
Botox® (onabotulinumtoxinA) received
FDA approval for an additional indication for the treatment of adults with upper limb spasticity. The expanded label now includes the addition of two thumb muscles: flexor pollicis longus, a muscle in the forearm that flexes the thumb; and adductor pollicis, a muscle in the hand that functions to adduct the thumb; increasing the maximum dose from 360 to 400 units for the treatment of upper limb spasticity.
Regulatory Submissions & Clinical Data
-
Actavis announced that a sNDA for Teflaro® (ceftaroline fosamil) was accepted byFDA to expand the product label to support use in cases of acute bacterial skin and skin structure infections (ABSSSI) with concurrent bacteremia. Under the Prescription Drug User Fee Act (PDUFA), theFDA has set a target of third quarter 2015 to complete its review. -
Actavis andGideon Richter announced that the Cariprazine NDA resubmission was accepted byFDA for the potential treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The PDUFA date for Cariprazine is expected to be inJune 2015 . -
Actavis andRhythm Health announced the initiation of a Phase 2b clinical data assessing the efficacy and safety of relamorelin(RM-131) for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. -
Actavis announced positive top-line results for a phase 3 study comparing a single 1500 mg dose of Dalvance® (dalbavancin) with the same total dose given as two-doses one week apart, for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). - Xydalba™ (dalbavancin) received EMA approval for the treatment of ABSSSI in adults. XydalbaTM is the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen.
North American Generics and International
- Confirmed 7 first-to-file (FTF) opportunities including generic versions of Uceris®, Letairis®, and Mirvaso®. Actavis' FTF performance continues to lead the industry.
Upcoming Pipeline Milestones
-
The PDUFA date for Eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D) is expected in Q2 2015.
Drug Enforcement Agency scheduling for the drug would commence followingFDA approval. The PDUFA date for Cariprazine, a potential treatment of patients with schizophrenia and patients with manic or mixed episodes associated with bipolar I disorder is expected in the second quarter of 2015. - A sNDA submission for Linzess® as a potential low dose version for the treatment of patients with Chronic Idiopathic Constipation (CIC) is scheduled for 2016.
-
Phase II studies of DARPin®, a potential treatment for wet Neovascular Age-related Macular Degeneration (AMD), are ongoing in
Japan and inthe United States . A Phase III study is expected to begin enrollment in late second quarter or early third quarter of 2015. - A U.S. submission for a multi-dose preservative free formulation of Restasis® is planned by the end of 2015.
-
Phase III trials are currently recruiting in the U.S. and will be initiated in the
European Union (EU) later this year for Bimataprost SR, a potential treatment for glaucoma. - Phase III data for SER 120, a low-dose nasal formulation for the treatment of Nocturia, is expected to be available later in 2015.
-
In Dermal Fillers, an EU approval extension for Juvederm® Volite and a dose range approval for Juvederm® in
China andJapan are expected later in 2015.
Preliminary 2015 Financial Outlook
-
Total Net Revenues (As Reported) of between
$20.5 - $21.0 Billion -
Pro
Forma 2015 net revenue between$22.0 - $22.5 Billion
-
Pro
-
Non-GAAP earnings per share (As Reported) of between
$17.00 to $18.50 - Fully Diluted Average Shares approximately 386 million
- Year-End 2015 Fully Diluted Shares Outstanding approximately 415 million
- Non-GAAP tax rate is anticipated to be approximately 15%.
Webcast and Conference Call Details
A replay of the conference call will also be available beginning approximately two hours after the call's conclusion and will remain available through
About
With commercial operations in approximately 100 countries,
For more information, visit
Actavis Cautionary Statement Regarding Forward-Looking Statements
Statements contained in this communication that refer to
The following table presents
Table 1 |
|||||||
ACTAVIS PLC |
|||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||
(Unaudited; in millions, except per share amounts) |
|||||||
Three Months Ended |
|||||||
March 31, |
|||||||
2015 |
2014 |
||||||
Net revenues |
$ 4,234.2 |
$ 2,655.1 |
|||||
Operating expenses: |
|||||||
Cost of sales (excludes amortization and impairment of acquired intangibles |
1,713.4 |
1,293.0 |
|||||
Research and development |
431.0 |
171.5 |
|||||
Selling, general and administrative |
1,428.5 |
558.9 |
|||||
Amortization |
925.4 |
424.2 |
|||||
Asset sales and impairments, net |
57.8 |
(0.4) |
|||||
Total operating expenses |
4,556.1 |
2,447.2 |
|||||
Operating (loss) / income |
(321.9) |
207.9 |
|||||
Non-operating income (expense): |
|||||||
Interest income |
1.8 |
1.0 |
|||||
Interest expense |
(171.9) |
(72.8) |
|||||
Other income (expense), net |
(198.0) |
5.0 |
|||||
Total other income (expense), net |
(368.1) |
(66.8) |
|||||
(Loss) / income before income taxes and noncontrolling interest |
(690.0) |
141.1 |
|||||
(Benefit) / provision for income taxes |
(177.7) |
44.4 |
|||||
Net (loss) / income |
(512.3) |
96.7 |
|||||
Loss / (income) attributable to noncontrolling interest |
0.3 |
(0.2) |
|||||
Net (loss) / income attributable to shareholders |
(512.0) |
96.5 |
|||||
Dividends on preferred stock |
23.2 |
- |
|||||
Net (loss) / income attributable to ordinary shareholders |
$ (535.2) |
$ 96.5 |
|||||
(Loss) / earnings per share attributable to ordinary shareholders: |
|||||||
Basic |
$ (1.85) |
$ 0.56 |
|||||
Diluted |
$ (1.85) |
$ 0.55 |
|||||
Weighted average shares outstanding: |
|||||||
Basic |
289.5 |
173.8 |
|||||
Diluted |
289.5 |
174.9 |
The following table details product revenue for significant products within the North American Brands segment for the three months ended
Table 2 |
|||||||
ACTAVIS PLC |
|||||||
NORTH AMERICA BRANDS SEGMENT REVENUE |
|||||||
(Unaudited; in millions) |
|||||||
QTD |
|||||||
Three Months |
|||||||
March 31, |
Change |
||||||
2015 |
2014 |
Dollars |
% |
||||
North American Brands |
|||||||
CNS |
|||||||
Namenda® IR |
$ 245.4 |
$ - |
$ 245.4 |
100.0% |
|||
Namenda XR® |
150.6 |
- |
150.6 |
100.0% |
|||
Viibyrd® / Fetzima ® |
79.6 |
- |
79.6 |
100.0% |
|||
Saphris ® |
42.0 |
- |
42.0 |
100.0% |
|||
Other CNS |
24.0 |
- |
24.0 |
100.0% |
|||
Total CNS |
541.6 |
- |
541.6 |
100.0% |
|||
Gastroenterology |
|||||||
Delzicol®/Asacol® HD |
136.2 |
140.8 |
(4.6) |
-3.3% |
|||
Linzess®/Costella ™ |
96.2 |
- |
96.2 |
100.0% |
|||
Carafate ® / Sulcrate ® |
54.3 |
- |
54.3 |
100.0% |
|||
Canasa ® / Salofalk ® |
37.3 |
- |
37.3 |
100.0% |
|||
Zenpep ®, Ultrase ® & Viokace ® |
40.2 |
- |
40.2 |
100.0% |
|||
Other Gastroenterology |
12.4 |
- |
12.4 |
100.0% |
|||
Total Gastroenterology |
376.6 |
140.8 |
235.8 |
167.5% |
|||
Women's Health |
|||||||
Lo Loestrin® Fe |
83.3 |
62.4 |
20.9 |
33.5% |
|||
Minastrin® 24 Fe |
65.4 |
47.9 |
17.5 |
36.5% |
|||
Estrace® Cream |
71.9 |
53.3 |
18.6 |
34.9% |
|||
Other Women's Health |
46.9 |
49.0 |
(2.1) |
-4.3% |
|||
Total Women's Health |
267.5 |
212.6 |
54.9 |
25.8% |
|||
Cardiovascular, Respiratory & Acute Care |
|||||||
Bystolic® |
164.1 |
- |
164.1 |
100.0% |
|||
Daliresp ® (1) |
23.6 |
- |
23.6 |
100.0% |
|||
Tudorza ® (1) |
28.2 |
- |
28.2 |
100.0% |
|||
Total Cardiovascular, Respiratory & Acute Care |
215.9 |
- |
215.9 |
100.0% |
|||
Urology |
68.3 |
72.1 |
(3.8) |
-5.3% |
|||
Infectious Disease |
37.8 |
- |
37.8 |
100.0% |
|||
Dermatology/Established Brands |
228.3 |
168.5 |
59.8 |
35.5% |
|||
Total North American Brands |
$ 1,736.0 |
$ 594.0 |
$ 1,142.0 |
192.3% |
|||
(1) Products were divested on March 2, 2015. |
The following table presents
Table 3 |
||||||
ACTAVIS PLC |
||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||
(Unaudited; in millions) |
||||||
March 31, |
December 31, |
|||||
2015 |
2014 |
|||||
Assets |
||||||
Cash and cash equivalents |
$ 2,114.9 |
$ 250.0 |
||||
Marketable securities |
16.0 |
1.0 |
||||
Accounts receivable, net |
3,992.8 |
2,372.3 |
||||
Inventories |
3,125.1 |
2,075.5 |
||||
Other current assets |
1,624.9 |
1,233.7 |
||||
Assets held for sale |
143.5 |
949.2 |
||||
Property, plant and equipment, net |
2,797.9 |
1,594.7 |
||||
Investments and other assets |
618.1 |
342.8 |
||||
Product rights and other intangibles, net |
74,201.1 |
19,188.4 |
||||
Goodwill |
50,826.4 |
24,521.5 |
||||
Total assets |
$ 139,460.7 |
$ 52,529.1 |
||||
Liabilities & Equity |
||||||
Current liabilities |
$ 7,638.1 |
$ 4,992.7 |
||||
Liabilities held for sale |
17.4 |
25.9 |
||||
Long-term debt and capital leases |
42,700.5 |
14,846.3 |
||||
Deferred income taxes and other liabilities |
17,695.2 |
4,328.7 |
||||
Total equity |
71,409.5 |
28,335.5 |
||||
Total liabilities and equity |
$ 139,460.7 |
$ 52,529.1 |
The following table presents
Table 4 |
|||||||||
ACTAVIS PLC |
|||||||||
CONSOLIDATED STATEMENTS OF CASH FLOWS |
|||||||||
(Unaudited; in millions) |
|||||||||
Three Months Ended March 31, |
|||||||||
2015 |
2014 |
||||||||
Cash Flows From Operating Activities: |
|||||||||
Net (loss) / income |
$ (512.3) |
$ 96.7 |
|||||||
Reconciliation to net cash provided by operating activities: |
|||||||||
Depreciation |
57.2 |
55.6 |
|||||||
Amortization |
925.4 |
424.2 |
|||||||
Provision for inventory reserve |
30.3 |
38.1 |
|||||||
Share-based compensation |
225.5 |
16.7 |
|||||||
Deferred income tax benefit |
(304.3) |
(149.9) |
|||||||
Loss / (gain) on asset sale and impairment, net |
57.8 |
(0.4) |
|||||||
Amortization of inventory step up |
212.9 |
124.6 |
|||||||
Amortization of deferred financing costs |
268.3 |
11.1 |
|||||||
Accretion and contingent consideration |
28.8 |
(7.0) |
|||||||
Excess tax benefit from stock-based compensation |
(36.1) |
(36.8) |
|||||||
Other, net |
(6.5) |
(10.9) |
|||||||
Net (loss) / income, adjusted for non-cash activity |
947.0 |
562.0 |
|||||||
Changes in assets and liabilities (net of effects of acquisitions): |
|||||||||
Decrease / (increase) in accounts receivable, net |
(702.1) |
(113.6) |
|||||||
Decrease / (increase) in inventories |
(202.7) |
(108.9) |
|||||||
Decrease / (increase) in prepaid expenses and other current assets |
58.9 |
21.8 |
|||||||
Increase / (decrease) in accounts payable and accrued expenses |
356.1 |
(22.6) |
|||||||
Increase / (decrease) in income and other taxes payable |
42.4 |
113.1 |
|||||||
Increase / (decrease) in other assets and liabilities |
25.4 |
(12.2) |
|||||||
Total adjustments |
1,037.3 |
342.9 |
|||||||
Net cash provided by operating activities |
525.0 |
439.6 |
|||||||
Cash Flows From Investing Activities: |
|||||||||
Additions to property, plant and equipment |
(136.6) |
(42.5) |
|||||||
Additions to product rights and other intangibles |
(8.5) |
- |
|||||||
Additions to investments |
(15.0) |
- |
|||||||
Proceeds from the sale of investments and other assets |
790.5 |
15.0 |
|||||||
Proceeds from sales of property, plant and equipment |
74.9 |
3.4 |
|||||||
Acquisitions of business, net of cash acquired |
(34,646.2) |
- |
|||||||
Net cash (used in) investing activities |
(33,940.9) |
(24.1) |
|||||||
Cash Flows From Financing Activities: |
|||||||||
Proceeds from borrowings of indebtedness |
29,265.6 |
- |
|||||||
Debt issuance and other financing costs |
(310.8) |
(20.3) |
|||||||
Payments on debt, including capital lease obligations |
(2,660.0) |
(326.1) |
|||||||
Proceeds from issuance of preferred shares |
4,929.7 |
- |
|||||||
Proceeds from issuance of ordinary shares |
4,071.1 |
- |
|||||||
Proceeds from stock plans |
42.6 |
6.4 |
|||||||
Payments of contingent consideration |
(24.6) |
(7.8) |
|||||||
Repurchase of ordinary shares |
(64.1) |
(57.0) |
|||||||
Excess tax benefit from stock-based compensation |
36.1 |
36.8 |
|||||||
Net cash provided / (used in) by financing activities |
35,285.6 |
(368.0) |
|||||||
Effect of currency exchange rate changes on cash and cash equivalents |
(4.8) |
(1.9) |
|||||||
Movement in cash held for sale |
- |
(36.9) |
|||||||
Net increase / (decrease) in cash and cash equivalents |
1,864.9 |
8.7 |
|||||||
Cash and cash equivalents at beginning of period |
250.0 |
329.0 |
|||||||
Cash and cash equivalents at end of period |
$ 2,114.9 |
$ 337.7 |
The following table presents
Table 5 |
||||||||||||||
ACTAVIS PLC |
||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS TO NON-GAAP STATEMENT OF OPERATIONS |
||||||||||||||
(Unaudited; in millions, except per share amounts) |
||||||||||||||
Three Months Ended |
Three Months Ended |
|||||||||||||
March 31, 2015 |
March 31, 2014 |
|||||||||||||
GAAP |
Adjustments |
Non-GAAP |
GAAP |
Adjustments |
Non-GAAP |
|||||||||
Net revenues |
$ 4,234.2 |
$ (31.5) |
(1) |
$ 4,202.7 |
$ 2,655.1 |
$ (112.1) |
(1) |
$ 2,543.0 |
||||||
Operating expenses: |
||||||||||||||
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) |
1,713.4 |
(349.9) |
(2) |
1,363.5 |
1,293.0 |
(215.2) |
(11) |
1,077.8 |
||||||
Research and development |
431.0 |
(147.0) |
(3) |
284.0 |
171.5 |
3.1 |
(12) |
174.6 |
||||||
Selling, general and administrative |
1,428.5 |
(550.9) |
(4) |
877.6 |
558.9 |
(71.1) |
(13) |
487.8 |
||||||
Amortization |
925.4 |
(925.4) |
(5) |
- |
424.2 |
(424.2) |
(5) |
- |
||||||
Asset sales and impairments, net |
57.8 |
(57.8) |
(6) |
- |
(0.4) |
0.4 |
- |
|||||||
Total operating expenses |
4,556.1 |
(2,031.0) |
2,525.1 |
2,447.2 |
(707.0) |
1,740.2 |
||||||||
Operating (loss) / income |
(321.9) |
1,999.5 |
1,677.6 |
207.9 |
594.9 |
802.8 |
||||||||
Non-operating income (expense): |
||||||||||||||
Interest income |
1.8 |
- |
1.8 |
1.0 |
- |
1.0 |
||||||||
Interest expense |
(171.9) |
(11.8) |
(7) |
(183.7) |
(72.8) |
(5.5) |
(14) |
(78.3) |
||||||
Other income (expense), net |
(198.0) |
198.6 |
(8) |
0.6 |
5.0 |
0.1 |
(15) |
5.1 |
||||||
Total other income (expense), net |
(368.1) |
186.8 |
(181.3) |
(66.8) |
(5.4) |
(72.2) |
||||||||
(Loss) / income before income taxes and noncontrolling interest |
(690.0) |
2,186.3 |
1,496.3 |
141.1 |
589.5 |
730.6 |
||||||||
(Benefit) / provision for income taxes |
(177.7) |
391.8 |
(9) |
214.1 |
44.4 |
75.1 |
(9) |
119.5 |
||||||
Net (loss) / income |
(512.3) |
1,794.5 |
1,282.2 |
96.7 |
514.4 |
611.1 |
||||||||
Loss / (income) attributable to noncontrolling interest |
0.3 |
- |
0.3 |
(0.2) |
- |
(0.2) |
||||||||
Net (loss) / income attributable to shareholders |
(512.0) |
1,794.5 |
1,282.5 |
96.5 |
514.4 |
610.9 |
||||||||
Dividends on preferred stock |
23.2 |
(23.2) |
(10) |
- |
- |
- |
(10) |
- |
||||||
Net (loss) / income attributable to ordinary shareholders |
$ (535.2) |
$ 1,817.7 |
$ 1,282.5 |
$ 96.5 |
$ 514.4 |
$ 610.9 |
||||||||
(Loss) / earnings per share attributable to ordinary shareholders: |
||||||||||||||
Basic |
$ (1.85) |
$ 4.43 |
$ 0.56 |
$ 3.51 |
||||||||||
Diluted |
$ (1.85) |
$ 4.30 |
$ 0.55 |
$ 3.49 |
||||||||||
Weighted average shares outstanding: |
||||||||||||||
Basic |
289.5 |
289.5 |
173.8 |
173.8 |
||||||||||
Diluted |
289.5 |
298.5 |
174.9 |
174.9 |
||||||||||
Footnotes to the statement |
||||||||||||||
(1) |
Net revenues – Amounts included in the quarters ended March 31, 2015 and 2014 represents the continuing results from Western European assets sold in the second quarter of 2014. |
|||||||||||||
(2) |
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) – Amount in cost of sales in the quarter ended March 31, 2015 includes amortization of the Forest ($136.8 million), Allergan ($71.0 million), Durata and Warner Chilcott related inventory step ups of $212.9 million as the inventory acquired in each acquisition was sold to the Company's third party customers. Cost of sales in the quarter ended March 31, 2015 includes the expensing of inventory, inclusive of the purchase accounting step up, related to unsalable inventory resulting the sale of the Company's respiratory products of $35.3 million. Also included in cost of sales was severance and severance related costs incurred in connection with the Allergan acquisition of $14.5 million, the acquisition accounting impact on stock-based compensation (including acceleration charges) associated with the Allergan and Forest acquisitions of $7.3 million, the impact of the Company's global supply chain excellence initiative of $17.8 million, expenses associated with the fair market value adjustments and accretion of contingent consideration obligations of $28.0 million, amounts recorded from the continuing results from Western European assets sold in the second quarter of 2014 of $32.7 million, and other miscellaneous items. |
|||||||||||||
(3) |
Research and development – Research and development costs in the quarter ended March 31, 2015, primarily included severance and severance related costs incurred in connection with the Allergan acquisition of $60.6 million, severance and severance related costs incurred in connection with the Forest acquisition of $8.8 million, the acquisition accounting impact on stock-based compensation (including acceleration charges) associated with the Allergan and Forest acquisitions of $66.3 million and milestone payments associated with select R&D projects of $10.0 million. |
|||||||||||||
(4) |
Selling, general and administrative – Selling and marketing costs in the quarter ended March 31, 2015, primarily included severance and severance related costs incurred in connection with the Allergan acquisition of $62.2 million, severance and severance related costs incurred in connection with the Forest acquisition of $16.8 million and the acquisition accounting impact on stock-based compensation (including acceleration charges) associated with the Allergan and Forest acquisitions of $36.1 million. General and administrative costs in the quarter ended March 31, 2015 primarily included merger success and financing related acquisition fees associated with the Allergan acquisition of $78.4 million, integration expenses associated with the Allergan and Forest acquisitions of $12.9 million, the foreign exchange impact on contingent consideration obligations of $15.0 million, severance and severance related costs incurred in connection with the Allergan acquisition of $117.6 million, severance and severance related costs incurred in connection with the Forest acquisition and the acquisition accounting impact on stock-based compensation (including acceleration charges) associated with the Allergan and Forest acquisitions of $196.4 million. |
|||||||||||||
(5) |
Amortization – Includes amortization of acquired intangibles including product rights. |
|||||||||||||
(6) |
Asset sales and impairments, net – Asset sales and impairments, net, in the quarter ended March 31, 2015, included a loss on the impairment of our Australian generics business held for sale of $44.5 million, the impairment of certain IPR&D projects of $3.7 million and the movement in the fair value of other assets held for sale of $15.3 million, offset by miscellaneous gains. |
|||||||||||||
(7) |
Interest expense - Amount in interest expense includes the amortization of the fair value step up of senior secured notes assumed as part of the Forest and Allergan acquisitions. |
|||||||||||||
(8) |
Other income (expense) – Amount in other income (expense) in the quarter ended March 31, 2015 primarily includes the amortization of bridge loan commitment fees incurred in connection with the Allergan acquisition of $263.0 million, a gain on an interest rate lock entered into in connection with the Allergan acquisition of $31.0 million and a gain on the sale of the respiratory business of $33.5 million. |
|||||||||||||
(9) |
Provision for income taxes - In addition to the income tax impact on the items above, the provision for income taxes included the impact of select discrete items. |
|||||||||||||
(10) |
Dividends on preferred stock - The dividend impact is excluded from dilutive EPS as the Company is assuming the "if-converted" method of preferred shares. |
|||||||||||||
(11) |
Cost of sales (excludes amortization and impairment of acquired intangibles including product rights) – Amount in cost of sales in the quarter ended March 31, 2014 primarily includes amortization of the Warner Chilcott related inventory step up of $124.6 million as the inventory acquired in the acquisition was sold to the Company's third party customers. Also included in cost of sales is the impact of the Company's global supply chain excellence initiative of $11.4 million and amounts recorded from the continuing results from Western European assets sold in Q2 14 of $78.3 million. |
|||||||||||||
(12) |
Research and development – Amounts in research and development expenses in the quarter ended March 31, 2014 includes fair market value adjustments relating to contingent consideration liabilities assumed as part of acquisition accounting, including accretion, which created income in the quarter of $7.3 million as well as integration and other costs of $1.5 million and amounts recorded from the continuing results from Western European assets sold in the second quarter of 2014 of $2.7 million. |
|||||||||||||
(13) |
Selling, general and administrative – Selling and marketing costs in the quarter ended March 31, 2014 primarily included continuing results from Western European assets sold in the second quarter of 2014 of $26.6 million. General and administrative expenses in the quarter ended March 31, 2014 primarily included fees incurred for the then pending acquisition of Forest Laboratories of $14.2 million, restructuring and integration charges for the acquisitions of legacy Actavis and for Warner Chilcott of $14.2 million which included continuing benefit expenses for severed employees of $5.0 million, stock-based compensation of $5.0 million and other integration expenses. Also included in general and administrative expenses were cost associated with holding our Western European assets for sale of $5.2 million as well as continuing results from Western European assets sold in the second quarter of 2014 of $6.9 million. |
|||||||||||||
(14) |
Interest expense - Amount in interest expense includes the amortization of the fair value step up of senior secured notes assumed as part of the Warner Chilcott acquisition. |
|||||||||||||
(15) |
Other income (expense) – Amount in other income (expense) in the quarter ended March 31, 2014 includes the amortization expenses relating to the bridge loan commitments entered into in connection with the then pending acquisition of Forest Laboratories, Inc. of $9.4 million, fees received by former Legacy Actavis shareholders to end their restricted trading window of $5.0 million and a gain on the sale of our investment in Columbia Laboratories, Inc. of $4.3 million. |
The following table presents a reconciliation of reported net (loss) / income attributable to ordinary shareholders and diluted earnings per share to non-GAAP net income and diluted earnings per share for the three months ended
Table 6 |
||||||
ACTAVIS PLC |
||||||
RECONCILIATION TABLE |
||||||
(Unaudited; in millions except per share amounts) |
||||||
Three Months Ended |
||||||
March 31, |
||||||
2015 |
2014 |
|||||
GAAP to non-GAAP net income calculation |
||||||
Reported GAAP net (loss) / income attributable to ordinary shareholders |
$ (512.0) |
$ 96.5 |
||||
Adjusted for: |
||||||
Amortization |
925.4 |
424.2 |
||||
Global supply chain initiative(1) |
17.8 |
15.4 |
||||
Acquisition and licensing charges (2) |
1,173.4 |
144.4 |
||||
Accretion on contingent liabilities |
4.0 |
4.0 |
||||
Impairment/asset sales and related costs |
65.1 |
2.9 |
||||
Non-recurring losses (gains) |
- |
(1.4) |
||||
Legal settlements |
0.6 |
- |
||||
Income taxes on items above |
(391.8) |
(75.1) |
||||
Non-GAAP net income attributable to |
$ 1,282.5 |
$ 610.9 |
||||
Diluted earnings per share |
||||||
Diluted (loss) earnings per share - GAAP |
$ (1.85) |
$ 0.55 |
||||
Diluted earnings per share - Non-GAAP |
$ 4.30 |
$ 3.49 |
||||
Basic weighted average ordinary shares outstanding |
289.5 |
173.8 |
||||
Effect of dilutive securities: |
||||||
Dilutive shares |
9.0 |
1.1 |
||||
Diluted weighted average ordinary shares outstanding |
298.5 |
174.9 |
||||
Impact from Allergan Acquisition |
||||||
Non-GAAP net income attributable to ordinary shareholders |
$ 1,282.5 |
$ 610.9 |
||||
Non-GAAP net income attributable to ordinary shareholders resulting |
(46.8) |
- |
||||
Non-GAAP net income attributable to ordinary shareholders excluding |
$ 1,235.7 |
$ 610.9 |
||||
Diluted weighted average ordinary shares outstanding |
298.5 |
174.9 |
||||
Diluted weighted average ordinary shares resulting from the Allergan |
(29.3) |
- |
||||
Diluted weighted average ordinary shares outstanding excluding |
269.2 |
174.9 |
||||
Pro Forma diluted earnings per share - Non-GAAP, excluding the impact |
4.59 |
3.49 |
||||
(1) |
Includes accelerated depreciation charges. |
|||||
(2) |
Includes stock-based compensation due to the Allergan, Forest and Warner Chilcott acquisitions. |
|||||
(3) |
Includes the non-gaap contribution of Allergan as well as financing related expenses. |
|||||
(4) |
Includes the issuance of ordinary and preferred shares on March 2, 2015 as well as shares issued to Allergan shareholders on March 17, 2015. |
The following table presents a reconciliation of reported net (loss) / income attributable to ordinary shareholders for the three months ended
Table 7 |
||||||
ACTAVIS PLC |
||||||
ADJUSTED EBITDA, RECONCILIATION TABLE |
||||||
(Unaudited; in millions) |
||||||
Three Months Ended |
||||||
March 31, |
||||||
2015 |
2014 |
|||||
GAAP net (loss) / income attributable to ordinary shareholders |
$ (512.0) |
$ 96.5 |
||||
Plus: |
||||||
Interest expense |
171.9 |
72.8 |
||||
Interest income |
(1.8) |
(1.0) |
||||
(Benefit) / provision for income taxes |
(177.7) |
44.4 |
||||
Depreciation (includes accelerated depreciation) |
57.2 |
55.6 |
||||
Amortization |
925.4 |
424.2 |
||||
EBITDA |
463.0 |
692.5 |
||||
Adjusted for: |
||||||
Global supply chain initiative |
17.8 |
6.1 |
||||
Acquisition and licensing and other charges |
879.0 |
139.4 |
||||
Impairment/asset sales and related costs |
65.1 |
2.9 |
||||
Non-recurring losses (gains) |
- |
(1.4) |
||||
Legal settlements |
0.6 |
- |
||||
Accretion on contingent liabilities |
4.0 |
4.0 |
||||
Share-based compensation |
352.6 |
16.7 |
||||
Adjusted EBITDA |
$ 1,782.1 |
$ 860.2 |
||||
Impact from Allergan Acquisition |
||||||
EBITDA contribution from the Allergan Acquisition |
(113.2) |
- |
||||
Adjusted EBITDA excluding Allergan Acquisition |
$ 1,668.9 |
$ 860.2 |
The following table presents a reconciliation of reported net revenues and cost of sales by segment for the three months ended
Table 8 |
|||||||||||||||||||||
ACTAVIS PLC |
|||||||||||||||||||||
ADJUSTED GROSS MARGIN AS A PERCENTAGE OF ADJUSTED NET REVENUES |
|||||||||||||||||||||
(Unaudited; $ in millions) |
|||||||||||||||||||||
Three Months Ended |
Three Months Ended |
||||||||||||||||||||
March 31, 2015 |
March 31, 2014 |
||||||||||||||||||||
North American Brands |
North |
Anda |
Allergan |
Total |
North American Brands |
North |
Anda |
Allergan |
Total |
||||||||||||
Net Revenues: |
|||||||||||||||||||||
Net revenues |
$ 1,736.0 |
$ 1,778.2 |
$ 461.6 |
$ 258.4 |
$ 4,234.2 |
$ 594.0 |
$ 1,670.9 |
$ 390.2 |
$ - |
$ 2,655.1 |
|||||||||||
Adjustments to net revenue ((remove from) |
|||||||||||||||||||||
Operating results of assets held for sale |
- |
(31.5) |
- |
- |
(31.5) |
- |
(112.1) |
- |
- |
(112.1) |
|||||||||||
Adjusted net revenues |
$ 1,736.0 |
$ 1,746.7 |
$ 461.6 |
$ 258.4 |
$ 4,202.7 |
$ 594.0 |
$ 1,558.8 |
$ 390.2 |
$ - |
$ 2,543.0 |
|||||||||||
Cost of Sales (1): |
|||||||||||||||||||||
Cost of Sales |
$ 372.0 |
$ 826.8 |
$ 404.0 |
$ 110.6 |
$ 1,713.4 |
$ 185.5 |
$ 776.3 |
$ 331.2 |
$ - |
$ 1,293.0 |
|||||||||||
Adjustments to cost of sales ((remove from) / add to) |
|||||||||||||||||||||
Integration and restructuring |
(3.9) |
(3.8) |
- |
(8.2) |
(15.9) |
(0.6) |
- |
- |
- |
(0.6) |
|||||||||||
Contingent consideration fair value and |
29.1 |
(57.1) |
- |
- |
(28.0) |
(0.3) |
- |
- |
- |
(0.3) |
|||||||||||
Operating results and disposal impact |
(35.3) |
(32.7) |
- |
- |
(68.0) |
- |
(78.3) |
- |
- |
(78.3) |
|||||||||||
Operational Excellence Initiative |
- |
(17.8) |
- |
- |
(17.8) |
- |
(11.4) |
- |
- |
(11.4) |
|||||||||||
Acquisition accounting fair market |
(1.0) |
- |
- |
(6.3) |
(7.3) |
- |
- |
- |
- |
- |
|||||||||||
Purchase accounting adjustments |
(127.7) |
(14.2) |
- |
(71.0) |
(212.9) |
(112.7) |
(11.9) |
- |
- |
(124.6) |
|||||||||||
Adjusted cost of sales |
$ 233.2 |
$ 701.2 |
$ 404.0 |
$ 25.1 |
$ 1,363.5 |
$ 71.9 |
$ 674.7 |
$ 331.2 |
$ - |
$ 1,077.8 |
|||||||||||
Adjusted gross profit |
1,502.8 |
1,045.5 |
57.6 |
233.3 |
2,839.2 |
522.1 |
884.1 |
59.0 |
- |
1,465.2 |
|||||||||||
Adjusted gross margin as a percentage of |
86.6% |
59.9% |
12.5% |
90.3% |
67.6% |
87.9% |
56.7% |
15.1% |
57.6% |
||||||||||||
(1) Cost of sales excludes amortization and impairment of acquired intangibles. |
The following table presents a reconciliation of reported net revenues and SG&A by segment for the three months ended
Table 9 |
|||||||||||||||||||||
ACTAVIS PLC |
|||||||||||||||||||||
ADJUSTED SG&A AS A PERCENTAGE OF ADJUSTED NET REVENUES |
|||||||||||||||||||||
(Unaudited; in millions) |
|||||||||||||||||||||
Three Months Ended |
Three Months Ended |
||||||||||||||||||||
March 31, 2015 |
March 31, 2014 |
||||||||||||||||||||
North |
North |
Anda |
Allergan |
Total |
North |
North |
Anda |
Allergan |
Total |
||||||||||||
Net Revenues: |
|||||||||||||||||||||
Net revenues |
$ 1,736.0 |
$ 1,778.2 |
$ 461.6 |
$ 258.4 |
$ 4,234.2 |
$ 594.0 |
$ 1,670.9 |
$ 390.2 |
$ - |
$ 2,655.1 |
|||||||||||
Adjustments to net revenue |
|||||||||||||||||||||
Operating results of assets held |
- |
(31.5) |
- |
- |
(31.5) |
- |
(112.1) |
- |
- |
(112.1) |
|||||||||||
Adjusted net revenues |
$ 1,736.0 |
$ 1,746.7 |
$ 461.6 |
$ 258.4 |
$ 4,202.7 |
$ 594.0 |
$ 1,558.8 |
$ 390.2 |
$ - |
$ 2,543.0 |
|||||||||||
SG&A: |
|||||||||||||||||||||
SG&A |
$ 692.9 |
$ 292.6 |
$ 40.5 |
$ 402.5 |
$ 1,428.5 |
$ 159.1 |
$ 365.0 |
$ 34.8 |
$ - |
$ 558.9 |
|||||||||||
Adjustments to SG&A ((remove |
|||||||||||||||||||||
Acquisition, integration & |
(114.2) |
(56.2) |
- |
(104.4) |
(274.8) |
(8.5) |
(8.0) |
- |
- |
(16.5) |
|||||||||||
Acquisition related currency |
- |
39.7 |
- |
- |
39.7 |
- |
- |
- |
- |
- |
|||||||||||
Costs associated with holding |
- |
- |
- |
- |
- |
- |
(5.2) |
- |
- |
(5.2) |
|||||||||||
Global supply chain initiative |
- |
- |
- |
- |
- |
- |
(3.1) |
- |
- |
(3.1) |
|||||||||||
Other |
(0.6) |
- |
- |
- |
(0.6) |
- |
1.4 |
- |
- |
1.4 |
|||||||||||
Acquisition related costs |
(65.5) |
(12.9) |
- |
- |
(78.4) |
(14.2) |
- |
- |
- |
(14.2) |
|||||||||||
Operating results and disposal |
- |
(4.3) |
- |
- |
(4.3) |
- |
(33.5) |
- |
- |
(33.5) |
|||||||||||
Acquisition accounting fair |
(30.5) |
- |
- |
(202.0) |
(232.5) |
- |
- |
- |
- |
- |
|||||||||||
Adjusted SG&A |
$ 482.1 |
$ 258.9 |
$ 40.5 |
$ 96.1 |
$ 877.6 |
$ 136.4 |
$ 316.6 |
$ 34.8 |
$ - |
$ 487.8 |
|||||||||||
Adjusted SG&A as a percentage |
27.8% |
14.8% |
8.8% |
37.2% |
20.9% |
23.0% |
20.3% |
8.9% |
19.2% |
The following table presents a reconciliation of
Table 10 |
||||||||||
ACTAVIS PLC |
||||||||||
ADJUSTED R&D EXPENSE |
||||||||||
(Unaudited; $ in millions) |
Three Months Ended March 31, 2015 |
|||||||||
Generic Development |
Brand Development |
Biosimilars |
Allergan |
Total |
||||||
Research and Development expense |
$ 111.4 |
$ 166.4 |
$ 14.5 |
$ 138.7 |
$ 431.0 |
|||||
Adjustments to research and development ((remove from) / add to) |
||||||||||
Contingent consideration fair value adjustments adjustments and accretion |
- |
(0.5) |
- |
- |
(0.5) |
|||||
Brand related milestone payments and upfront option payments |
- |
(10.0) |
- |
- |
(10.0) |
|||||
Acquisition, integration & restructuring expenses |
(1.7) |
(17.1) |
- |
(51.4) |
(70.2) |
|||||
Acquisition accounting fair market value adjustment to stock-based compensation |
- |
(13.3) |
- |
(53.0) |
(66.3) |
|||||
Adjusted research and development expense |
$ 109.7 |
$ 125.5 |
$ 14.5 |
$ 34.3 |
$ 284.0 |
|||||
(Unaudited; $ in millions) |
Three Months Ended March 31, 2014 |
|||||||||
Generic Development |
Brand Development |
Biosimilars |
Allergan |
Total |
||||||
Research and Development expense |
$ 113.9 |
$ 33.3 |
$ 24.3 |
$ - |
$ 171.5 |
|||||
Adjustments to research and development ((remove from) / add to) |
||||||||||
Contingent consideration fair value adjustments adjustments and accretion |
- |
7.3 |
- |
- |
7.3 |
|||||
Operating results for assets held for sale |
(2.7) |
- |
- |
- |
(2.7) |
|||||
Brand related milestone payments and upfront option payments |
- |
- |
- |
- |
- |
|||||
Accelerated depreciation and product transfer costs |
(0.9) |
- |
- |
- |
(0.9) |
|||||
Acquisition, integration & restructuring expenses |
(0.3) |
- |
- |
- |
(0.3) |
|||||
Acquisition related settlements |
- |
(0.3) |
- |
- |
(0.3) |
|||||
Adjusted research and development expense |
$ 110.0 |
$ 40.3 |
$ 24.3 |
$ - |
$ 174.6 |
The following table presents a reconciliation of expected Non-GAAP Earnings per Share for the twelve months ending
Table 11 |
||||
ACTAVIS PLC |
||||
NON-GAAP EPS RECONCILIATION TABLE |
||||
(Unaudited; in millions except per share amounts) |
||||
Twelve Months Ending |
||||
December 31, 2015 |
||||
Low |
High |
|||
GAAP to non-GAAP net income calculation |
||||
Reported GAAP net (loss) / income |
$ (483.0) |
$ 96.0 |
||
Adjusted for: |
||||
Amortization |
5,850.0 |
5,850.0 |
||
Acquisition and licensing charges |
2,350.0 |
2,350.0 |
||
Impairment/asset sales and related costs |
70.0 |
70.0 |
||
Accretion on contingent liability |
10.0 |
10.0 |
||
Other |
35.0 |
35.0 |
||
Income taxes on items above |
(1,270.0) |
(1,270.0) |
||
Non-GAAP net income attributable to |
$ 6,562.0 |
$ 7,141.0 |
||
Diluted earnings per share - Non-GAAP |
$ 17.00 |
$ 18.50 |
||
Diluted weighted average ordinary shares outstanding |
386.0 |
386.0 |
CONTACTS: |
Investors: |
Lisa DeFrancesco |
|
(862) 261-7152 |
|
Media: |
|
David Belian |
|
(862) 261-8141 |