Teva Reports Fourth Quarter and Full Year 2018 Financial Results JERUSALEM--(BUSINESS WIRE)

Teva Reports Fourth Quarter and Full Year 2018 Financial Results

JERUSALEM--(BUSINESS WIRE)--February 13, 2019--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the year and the quarter ended December 31, 2018.

2019 Business outlook:

Mr. K re Schultz, Teva's President and CEO, said, "2018 was the first year of our restructuring plan and we have met or exceeded all of our key financial targets for the year. The full year yielded a cost base reduction of $2.2 billion, exceeding our 2018 target, and we are well on track to deliver the total $3.0 billion reduction in 2019 as compared to the 2017 spend base. AJOVY is performing very well since its September launch in the U.S. with growing demand for the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults. We will focus our investments on growing AJOVY and continuing our success with AUSTEDO , with both franchises positioned to be important growth drivers for Teva.

"Looking ahead, we continue to expect that 2019 will be the trough for our business, a year in which we will experience similar challenges to those of 2018 including the continued erosion of COPAXONE in the U.S. and Europe as well as the introduction of generics in the ProAir market. Throughout the year, we will continue to execute against our restructuring plan goals, including the optimization of our global portfolio and network, as we focus our efforts on generating cash to reduce the company's debt."

2018 Annual Consolidated Results

Revenues in 2018 were $18,854 million, a decrease of 16% in both U.S. dollar and local currency terms, compared to 2017, mainly due to generic competition to COPAXONE , a decline in revenues in our U.S. generics business and loss of revenues following the divestment of certain products and discontinuation of certain activities.

Exchange rate movements between 2018 and 2017 positively impacted our revenues by $152 million, our GAAP operating income by $4 million and our non-GAAP operating income by $10 million.

GAAP gross profit was $8,296 million in 2018, a decrease of 22% compared to 2017. GAAP gross profit margin for 2018 was 44.0%, compared to 47.4% in 2017. Non-GAAP gross profit was $9,546 million in 2018, a decrease of 21% compared to 2017. Non-GAAP gross profit margin was 50.6% in 2018, compared to 53.8% in 2017. The decrease in both GAAP and non-GAAP gross profit was mainly due to lower profitability in North America resulting from a decline in COPAXONE revenues due to generic competition and a decline in revenues in our U.S. generics business, partially offset by higher profitability in Europe.

Research and Development (R&D) expenses in 2018 were $1,213 million, a decrease of 32% compared to 2017. R&D expenses excluding equity compensation expenses and purchase of in-process R&D in 2018 were $1,102 million, or 5.8% of revenues, compared to $1,515 million or 6.8% in 2017. The decrease in R&D expenses resulted primarily from pipeline optimization, phase 3 studies that have ended and related headcount reductions.

Selling and Marketing (S&M) expenses in 2018 were $2,916 million, a decrease of 14% compared to 2017. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $2,718 million, or 14.4% of revenues, in 2018, compared to $3,149 million, or 14.1% of revenues, in 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

General and Administrative (G&A) expenses in 2018 were $1,298 million, a decrease of 11% compared to 2017. G&A expenses excluding equity compensation expenses were $1,228 million in 2018, or 6.5% of revenues, compared to $1,413 million or 6.3% of revenues in 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

GAAP other income in 2018 was $291 million, compared to other income of $1,199 million in 2017. The decline in GAAP other income was primarily the result of none recurring income related to the divestment of our women's health business in 2017. Non-GAAP other income in 2018 was $225 million, an increase of 94% compared to $116 million in 2017, mainly due to higher Section 8 recoveries from multiple cases in Canada and recovery of lost profits in cases in which U.S. patent infringement litigation had previously prevented the sale of certain products.

GAAP Operating loss was $1,637 million in 2018 compared to operating loss of $17,484 million in 2017. The increase was mainly due higher goodwill impairment charges, higher intangible assets impairments and other asset impairments recorded in 2017. Non-GAAP operating income was $4,723 million, a decrease of 22% compared to $6,073 million in 2017.

Adjusted EBITDA (non-GAAP operating income, which excludes amortization and certain other items, and excluding depreciation expenses) in 2018 was $5,319 million, compared to $6,665 million in 2017.

In 2018, GAAP financial expenses were $959 million, compared to $895 million in 2017. Non-GAAP financial expenses were $893 in 2018, compared to $908 in 2017.

In 2018 we recognized a GAAP tax benefit of $195 million, or 8%, on pre-tax loss of $2,596 million. In 2017 we recognized a tax benefit of $1,933 million, or 11%, on pre-tax loss of $18,379 million. Our tax rate for 2018 was mainly affected by one-time legal settlements and divestments that had a low corresponding tax effect. Additionally, in 2018 we recorded impairments, some of which did not have a corresponding tax effect.

The non-GAAP income taxes for 2018 were $519 million on non-GAAP pre-tax income of $3,830 million. The non-GAAP income taxes in 2017 were $788 million on non-GAAP pre-tax income of $5,165 million. The non-GAAP tax rate for 2018 was 14%, compared to 15% in 2017. The decrease in our tax rate was mainly due to the reduction in the U.S. federal corporate tax rate following the U.S. tax reform.

GAAP net loss attributable to Teva's ordinary shareholders and GAAP diluted loss per share in 2018 were $2,399 million and $2.35, respectively, compared to net loss of $16,525 million and diluted loss per share of $16.26 in 2017. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS in 2018 were $2,985 million and $2.92, respectively, compared to $4,075 million and $4.01 in 2017.

The weighted average diluted shares outstanding used for the fully diluted share calculation on a GAAP basis for 2018 and 2017 were 1,021 and 1,016 million shares, respectively. The weighted average outstanding shares used for the fully diluted EPS calculation on a non-GAAP basis for 2018 and 2017 were 1,024 and 1,018 million shares, respectively.

As of December 31, 2018 and 2017, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,100 million and 1,086 million shares, respectively.

Non-GAAP information : Net non-GAAP adjustments in 2018 were $5,384 million. Non-GAAP net income and non-GAAP EPS for the year were adjusted to exclude the following items:

Teva believes that excluding such items facilitates investors' understanding of its business. For further information see the below tables for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and the information under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow generated from operating activities in 2018 was $2,446 million, an increase of $221 million, or 10% compared to 2017. This increase was mainly due to the working capital adjustment with Allergan and the Rimsa settlement in 2018, partially offset by lower profit in our North America segment.

Free cash flow (Cash flow generated from operating activities in 2018, net of cash used for capital investments and beneficial interest collected in exchange for securitized trade receivables) was $3,679 million, compared to $2,693 million in 2017. This increase resulted mainly from the higher cash flow generated from operating activities, higher beneficial interest collected in exchange for securitized trade receivables and lower capital expenditures.

As of December 31, 2018, our debt was $28,916 million, compared to $32,475 million as of December 31, 2017. The decrease was mainly due to senior notes and term loans repaid at maturity or prepaid with cash generated during the year. The portion of total debt classified as short-term as of December 31, 2018 was 8%, compared to 11% as of December 31, 2017, due to a decrease in current maturities. Our average debt maturity was approximately 6.8 years as of December 31, 2018, compared to 6.4 years as of December 31, 2017.

Annual Report on Form 10-K

Teva will file its Annual Report on Form 10-K with the SEC in the coming days. The report will include a complete analysis of the financial results for 2018 and will be available on Teva's website, http://ir.tevapharm.com , as well as on the SEC's website: http://www.sec.gov .

Fourth Quarter 2018 Consolidated Results

Revenues in the fourth quarter of 2018 were $4,559 million, a decrease of 16%, or 14% in local currency terms, compared to the fourth quarter of 2017, mainly due to generic competition to COPAXONE, a decline in revenues in our U.S. generics business and loss of revenues following the divestment of certain products and discontinuation of certain activities.

Exchange rate differences between the fourth quarter of 2018 and the fourth quarter of 2017 negatively impacted our revenues and GAAP operating income by $100 million and $13 million, respectively. Our non-GAAP operating income was negatively impacted by $17 million.

GAAP gross profit was $1,971 million in the fourth quarter of 2018, a decrease of 19% compared to the fourth quarter of 2017. GAAP gross profit margin was 43.2% in the fourth quarter of 2018, compared to 45.3% in the fourth quarter of 2017. Non-GAAP gross profit was $2,328 million in the fourth quarter of 2018, a decline of 15% from the fourth quarter of 2017. Non-GAAP gross profit margin was 51.1% in the fourth quarter of 2018, compared to 50.9% in the fourth quarter of 2017. The increase in gross profit margin on a non-GAAP basis resulted primarily from improved gross profit margin in our Europe segment.

Research and Development (R&D) expenses for the fourth quarter of 2018 were $295 million, a decrease of 15% compared to the fourth quarter of 2017. R&D expenses excluding equity compensation expenses and other expenses were $289 million, or 6.3% of quarterly revenues in the fourth quarter of 2018, compared to $295 million, or 5.5% of quarterly revenues in the fourth quarter of 2017. The decrease in R&D expenses resulted primarily from pipeline optimization, phase 3 studies that have ended and related headcount reduction.

Selling and Marketing (S&M) expenses in the fourth quarter of 2018 were $797 million, a decrease of 3% compared to the fourth quarter of 2017. S&M expenses excluding amortization of purchased intangible assets, equity compensation expenses and other expenses were $768 million, or 16.8% of quarterly revenues in the fourth quarter of 2018, compared to $749 million, or 13.9% of quarterly revenues in the fourth quarter of 2017. The increase was mainly due to higher promotional cost associated with the launch of AJOVY in the U.S., partially offset by cost reduction and efficiency measures as part of the restructuring plan.

General and Administrative (G&A) expenses in the fourth quarter of 2018 were $344 million, a decrease of 2% compared to the fourth quarter of 2017. G&A expenses excluding equity compensation expenses and other expenses were $330 million in the fourth quarter of 2018, or 7.2% of quarterly revenues in the fourth quarter of 2018, compared to $335 million, or 6.2% of quarterly revenues in the fourth quarter of 2017.

GAAP other loss in the fourth quarter of 2018 was $43 million, compared to other income of $1,099 million in the fourth quarter of 2017. Non-GAAP other income in the fourth quarter of 2018 was $5 million, compared to $15 million in fourth quarter of 2017.

GAAP operating loss in the fourth quarter of 2018 was $3,164 million, compared to $13,017 million in the fourth quarter of 2017. Non-GAAP operating income in the fourth quarter of 2018 was $946 million, a decrease of 32% compared to the fourth quarter of 2017. Non-GAAP operating margin was 20.8% in the fourth quarter of 2018 compared to 25.7% in the fourth quarter of 2017.

EBITDA (non-GAAP operating income, which excludes amortization and certain other items, as well as depreciation expenses) was $1,091 million in the fourth quarter of 2018, a decrease of 29% compared to $1,534 million in the fourth quarter of 2017.

GAAP financial expenses for the fourth quarter of 2018 were $223, compared to $191 million in the fourth quarter of 2017. Non-GAAP financial expenses were $216 million in the fourth quarter of 2018, compared to $209 million in the fourth quarter of 2017.

In the fourth quarter of 2018, we recognized a tax benefit of $139 million, or 4%, on pre-tax loss of $3,387 million. In the fourth quarter of 2017, we recognized a tax benefit of $1,471 million, on pre-tax loss of $13,208 million. Our tax rate for the fourth quarter of 2018 was mainly affected by impairments recorded, some of which did not have a corresponding tax effect. Non-GAAP income taxes for the fourth quarter of 2018 were $96 million, or 13%, on pre-tax non-GAAP income of $730 million. Non-GAAP income taxes in the fourth quarter of 2017 were $183 million, or 16%, on pre-tax non-GAAP income of $1,176 million.

GAAP net loss attributable to ordinary shareholders and GAAP diluted loss per share in the fourth quarter of 2018 were $2,940 million and $2.85, respectively, compared to loss of $11,600 million and $11.41 in the fourth quarter of 2017. Non-GAAP net income attributable to ordinary shareholders and non-GAAP diluted EPS in the fourth quarter of 2018 were $543 million and $0.53, respectively, compared to $949 million and $0.93 in the fourth quarter of 2017.

For the fourth quarter of 2018, the weighted average outstanding shares for the fully diluted EPS calculation on a GAAP basis was 1,031 million shares, compared to 1,017 million shares in the fourth quarter of 2017. The weighted average outstanding shares for the fully diluted EPS calculation on a non-GAAP basis was 1,034 million shares, compared to 1,018 million shares in the fourth quarter of 2017.

Non-GAAP information : Net non-GAAP adjustments in the fourth quarter of 2018 were $3,483 million. Non-GAAP net income and non-GAAP EPS for the fourth quarter were adjusted to exclude the following items:

Teva believes that excluding such items facilitates investors' understanding of its business. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP figures. Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.

Cash flow generated from operations during the fourth quarter of 2018 was $367 million, compared to $859 million in the fourth quarter of 2017. The decrease was mainly due to lower profit in our North America segment.

Free cash flow (Cash flow generated from operating activities, net of cash used for capital investments and beneficial interest collected in exchange for securitized trade receivables) was $522 million in the fourth quarter of 2018, compared to $934 million in the fourth quarter of 2017. The increase in 2018 resulted mainly from the higher cash flow generated from operating activities.

Segment Results for the Fourth Quarter 2018

Due to the organizational changes announced in November 2017, we began reporting our financial results under a new structure in the first quarter of 2018, consisting of the following segments:

a) North America segment, which includes the United States and Canada. b) Europe segment, which includes the European Union and certain other European countries. c) International Markets segment, which includes all countries other than those in our North America and Europe segments.

In addition to these three segments, we have other activities, primarily the sale of API to third parties and certain contract manufacturing services.

Segment profit is comprised of gross profit for the segment, less R&D, S&M, G&A expenses and other income related to each segment. Segment profit does not include amortization and certain other items.

The data presented in this press release for prior periods have been conformed to reflect our current segment reporting, which commenced in the first quarter of 2018.

North America Segment

Our North America segment includes the United States and Canada.

The following table presents revenues, expenses and profit for our North America segment for the three months ended December 31, 2018 and 2017:

Revenues from our North America segment in the fourth quarter of 2018 were $2,238 million, a decrease of $451 million, or 17%, compared to the fourth quarter of 2017, mainly due to a decline in revenues of COPAXONE, our U.S. generics business, ProAir and QVAR and the loss of revenues from the sale of our women's health business, partially offset by higher revenues from AUSTEDO and Anda.

Revenues in the United States , our largest market, were $2,103 million in the fourth quarter of 2018, a decrease of $434 million, or 17%, compared to the fourth quarter of 2017.

Revenues by Major Products and Activities

The following table presents revenues for our North America segment by major products and activities for the three months ended December 31, 2018 and 2017:

Generic products revenues in our North America segment in the fourth quarter of 2018 decreased by 10% to $1,099 million, compared to the fourth quarter of 2017, mainly due to additional competition to methylphenidate extended-release tablets (Concerta authorized generic), portfolio optimization primarily as part of the restructuring plan as well as market dynamics and price erosion in our U.S. generics business, partially offset by new generic product launches.

In the fourth quarter of 2018, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 504 million total prescriptions (based on trailing twelve months), representing 13% of total U.S. generic prescriptions according to IQVIA data.

COPAXONE revenues in our North America segment in the fourth quarter of 2018 decreased by 44% to $356 million, of which $341 million were generated in the United States, compared to the fourth quarter of 2017, mainly due to generic competition in the United States.

BENDEKA and TREANDA combined revenues in our North America segment in the fourth quarter of 2018 decreased by 11% to $140 million, compared to the fourth quarter of 2017, mainly due to lower volumes resulting from Eagle Pharmaceuticals' launch of a ready-to-dilute bendamustine hydrochloride in June 2018, partially offset by higher pricing.

ProAir revenues in our North America segment in the fourth quarter of 2018 decreased by 56% to $45 million, compared to the fourth quarter of 2017, mainly due to higher sales reserves recorded in the fourth quarter of 2018 in anticipation of generic competition to the short-acting beta-agonist class of drugs, including an approved generic version of Ventolin HFA. In the albuterol inhaler category, approximately 40% of prescriptions are written as "generic albuterol," which means that the launch of any generic inhaler may cause patient migration to such generic products. We launched our own ProAir authorized generic in the United States in January 2019.

QVAR revenues in our North America segment in the fourth quarter of 2018 decreased by 81% to $9 million, compared to the fourth quarter of 2017. The decrease in sales was mainly due to lower net pricing.

AUSTEDO revenues in our North America segment in the fourth quarter of 2018 were $68 million, compared to $17 million in the fourth quarter of 2017.

Anda revenues in our North America segment in the fourth quarter of 2018 increased by 26% to $363 million, compared to the fourth quarter of 2017.

North America Gross Profit

Gross profit from our North America segment in the fourth quarter of 2018 was $1,201 million, a decrease of 20% compared to $1,506 million in the fourth quarter of 2017. The decrease was mainly due to lower revenues from COPAXONE and generic products.

Gross profit margin for our North America segment in the fourth quarter of 2018 decreased to 53.7%, compared to 56.0% in the fourth quarter of 2017. This decrease was mainly due to lower COPAXONE revenues.

North America Profit

Profit from our North America segment in the fourth quarter of 2018 was $551 million, a decrease of 41% compared to $938 million in the fourth quarter of 2017. The decrease was mainly due to lower revenues from COPAXONE and generic products as well as investment in the launch of AJOVY.

Our Europe segment includes the European Union and certain other European countries.

The following table presents revenues, expenses and profit for our Europe segment for the three months ended December 31, 2018 and 2017:

Revenues from our Europe segment in the fourth quarter of 2018 were $1,204 million, a decrease of $246 million, or 17%, compared to the fourth quarter of 2017. In local currency terms, revenues decreased by 14%, mainly due to the loss of revenues from the closure of our distribution business in Hungary, the sale of our women's health business and a decline in COPAXONE revenues, partially offset by new generic product launches.

Revenues by Major Products and Activities