View printer-friendly version
« Back
November 15, 2016 7:01 a.m.
Teva Reports Third Quarter 2016 Results

Results include the generic business of Actavis, since August 2; Provides updated outlook for 2016.

JERUSALEM--(BUSINESS WIRE)--Nov. 15, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today reported results for the quarter ended September 30, 2016.

           

Q3 2016

Revenues $5.6 billion
Cash flow from operations $1.5 billion
GAAP EPS $0.35 984 million shares
Non-GAAP EPS $1.31 1,044 million shares
 

“This has been a year of transition for Teva, underscored this quarter by the close of our strategic acquisition of Actavis Generics, which had significant contribution to our results. Actavis will continue to contribute in a meaningful way to the future growth of our generics business through the strengthened R&D capabilities and complementary pipeline and portfolio, and enhance our leadership in an increasingly evolving industry,” stated Erez Vigodman, Teva’s President and CEO. “We were also pleased to report this quarter that we have successfully completed the second pivotal phase three study for SD-809 for tardive dyskinesia and plan to submit that NDA to the U.S. FDA at the end of this year, and have also resubmitted SD-809 for Huntington disease in response to the FDA's Complete Response Letter. Going forward, we will focus on also growing our specialty pipeline through in-house opportunities, including in the development and commercialization of our key pipeline assets, most notably our anti-CGRP product for migraine headaches and fasinumab. In the face of the industry and company-specific challenges we have been dealing with this year, we remain excited about the future as we strive to create a platform that is unique to the industry, working every day to find the delicate balance between access and innovation and laying the foundation for Teva's continued growth.”

Third Quarter 2016 Results

Revenues in the third quarter of 2016 were $5.6 billion, up 15% compared to the third quarter of 2015, primarily due to the inclusion of revenues of $887 million of the Actavis generics business, following the closing of the acquisition on August 2. Excluding the impact of foreign exchange fluctuations, revenues increased 19%.

Exchange rate differences between the third quarter of 2016 and the third quarter of 2015 reduced revenues by $188 million, GAAP operating income by $83 million and non-GAAP operating income by $65 million.

GAAP gross profit was $2.8 billion in the third quarter of 2016, up 1% compared to the third quarter of 2015. GAAP gross profit margin was 50.4% in the quarter, compared to 57.5% in the third quarter of 2015. Non-GAAP gross profit was $3.4 billion in the third quarter of 2016, up 14% from the third quarter of 2015. Non-GAAP gross profit margin was 61.0% in the third quarter of 2016, compared to 61.8% in the third quarter of 2015.

Research and Development (R&D) expenses for the third quarter of 2016 amounted to $663 million, an increase of 84% compared to the third quarter of 2015 mainly due to $250 million paid to Regeneron pursuant to our collaborative agreement to develop and commercialize its pain medication product fasinumab. R&D expenses excluding equity compensation expenses and purchase of in-process R&D in the third quarter of 2016 were $406 million, compared to $356 million in the third quarter of 2015. R&D expenses were 7.3% of revenues in the quarter, compared to 7.4% in the third quarter of 2015. R&D expenses related to our generic medicines segment were $184 million, compared to $132 million in the third quarter of 2015, an increase of 39%, mainly due to the inclusion of two months of expenses of the Actavis generics business. R&D expenses related to our specialty medicines segment were $228 million, an increase of 4% compared to $220 million in the third quarter of 2015.

Selling and Marketing (S&M) expenses in the third quarter of 2016 amounted to $940 million, an increase of 21% compared to the third quarter of 2015. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $889 million, or 16.0% of revenues, in the third quarter of 2016, compared to $766 million, or 15.9% of revenues, in the third quarter of 2015. S&M expenses related to our generic medicines segment were $415 million, an increase of 41% compared to $295 million in the third quarter of 2015, or 51% in local currency terms. The increase was mainly due to additional costs related to the inclusion of two months of expenses of the Actavis generics business and the launch of our business venture in Japan in the second quarter of 2016. S&M expenses related to our specialty medicines segment were $458 million, an increase of 10% compared to $417 million in the third quarter of 2015. The increase was mainly due to higher investments in new launches in the third quarter of 2016 and lower S&M activities in the third quarter of 2015.

General and Administrative (G&A) expenses in the third quarter of 2016 amounted to $310 million, compared to $316 million in the third quarter of 2015. G&A expenses excluding equity compensation expenses were $304 million in the third quarter of 2016, or 5.5% of revenues, compared to $307 million and 6.4% in the third quarter of 2015.

In light of advanced discussions with the U.S. Department of Justice and the U.S. Securities and Exchange Commission to settle our previously-disclosed FCPA investigations, we are establishing a provision of approximately $520 million. The provision relates to conduct in three countries, Russia, Mexico and Ukraine, during the time period covering 2007-2013. None of the conduct in question involved Teva's U.S. business.

Upon learning of FCPA concerns in 2012, Teva accelerated the pace of changes to address these issues by completely transforming its governance program and processes on every level. This resulted in actions including, terminating problematic business relationships with third parties, separating relevant employees from the company, fully overhauling the management of several subsidiaries, and ceasing operations in several countries. The company has also restructured through a new global organizational structure and chain of command that reduces risks.

The compliance program that Teva has in place now is serious, rigorous, and comprehensive and is designed to protect the company and its subsidiaries against future violations. Today, Teva has a culture of compliance that begins with a strong tone at the top -- including executive regional and local management -- and underpins every single business decision.

Quarterly GAAP operating income was $0.8 billion in the third quarter of 2016, down 24% compared to $1.0 billion in the third quarter of 2015. Quarterly non-GAAP operating income was $1.8 billion, up 16%, compared to $1.6 billion in the third quarter of 2015.

Adjusted EBITDA (non-GAAP operating income, which excludes amortization and certain other items, and excluding depreciation expenses) was $1.9 billion, up 16% compared to $1.7 billion in the third quarter of 2015.

GAAP financial expenses for the third quarter of 2016 were $150 million, compared to $697 million in the third quarter of 2015. Expenses in the third quarter of 2015 were mainly the result of a $623 million loss on our shares of Mylan, reflecting the price of Mylan’s shares as of September 30, 2015, while expenses in the current quarter were affected by the borrowings used to finance the acquisition of the Actavis generics business. Non-GAAP financial expenses were $151 million in the third quarter of 2016, compared to $65 million in the third quarter of 2015.

GAAP income tax expenses for the third quarter of 2016 were $207 million, or 34% on pre-tax income of $615 million. In the third quarter of 2015, the provision for income taxes was $193 million, or 62% on pre-tax income of $313 million. The provision for non-GAAP income taxes for the third quarter of 2016 was $261 million on pre-tax non-GAAP income of $1.6 billion, for a quarterly tax rate of 16%. The provision for non-GAAP income taxes in the third quarter of 2015 was $319 million on pre-tax non-GAAP income of $1.5 billion, for a quarterly tax rate of 21%.

We expect our annual non-GAAP tax rate for 2016 to be 18%, mainly due to synergies associated with the acquisition of the Actavis generics business and nonrecurring tax benefits in jurisdictions with higher tax rates.

GAAP net income attributable to Teva and GAAP diluted EPS were $412 million and $0.35, respectively, in the third quarter of 2016, compared to $103 million and $0.12, respectively, in the third quarter of 2015. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS were $1.4 billion and $1.31, respectively, in the third quarter of 2016, compared to $1.2 billion and $1.35 in the third quarter of 2015.

For the third quarter of 2016, the weighted average outstanding shares for the fully diluted earnings per share calculation was 984 million on a GAAP basis and 1,044 million on a non-GAAP basis. The number of average weighted diluted shares outstanding used for the fully diluted share calculation for the third quarter of 2015 was 862 million shares, on both a GAAP and non-GAAP basis. The increase in the number of shares resulted from our December 2015 equity offerings and from the issuance of shares to Allergan in August 2016 in connection with the closing of the Actavis acquisition. The number of shares on a non-GAAP basis includes the potential dilution resulting from our mandatory convertible preferred shares, which had a dilutive effect on our non-GAAP earnings per share.

As of September 30, 2016, the fully diluted share count for calculating Teva's market capitalization was approximately 1,088 million shares.

Non-GAAP information: Net non-GAAP adjustments in the third quarter of 2016 were $952 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:

  • Legal settlements and loss contingencies of $533 million, primarily a provision of approximately $520 million relating to the previously-mentioned FCPA investigations;
  • Amortization of purchased intangible assets totaling $429 million, of which $387 million is included in cost of goods sold and the remaining $42 million in selling and marketing expenses. This includes amortization expenses of $237 million related to Actavis' intangible assets;
  • Acquisition and related expenses, including contingent consideration, of $371 million, including $250 million paid to Regeneron pursuant to our collaborative agreement to develop and commercialize its pain medication product fasinumab and a contingent consideration expense of $43 million related to Bendeka™ as well as expenses related to the Actavis generics acquisition;
  • Inventory step-up of $152 million, related mainly to the acquisition of the Actavis generics business;
  • Restructuring expenses of $115 million, related mainly to the acquisition of the Actavis generics business;
  • Costs related to regulatory actions taken in facilities of $46 million;
  • Equity compensation expense of $31 million;
  • Impairment of long-lived assets of $29 million;
  • Net gain from other non-GAAP items of $678 million, including a net gain of $693 million from the divestments of products in connection with the acquisition of the Actavis generics business;
  • Minority interest adjustment of negative $22 million; and
  • Corresponding tax benefit of $54 million.

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.

Cash flow from operations generated during the third quarter of 2016 was $1.5 billion, an increase of 34% compared to the third quarter of 2015. The increase was mainly due to lower payments for legal settlements, partially offset by an increase in accounts receivable, net of SR&A, and an increase in inventories. Cash flow was affected by the inclusion of two months of the generic business of Actavis. Free cash flow, excluding net capital expenditures, was $1.2 billion, up 27% compared to the third quarter of 2015.

Total balance sheet assets were $98.7 billion as of September 30, 2016, compared to $57.9 billion as of June 30, 2016. The increase was mainly due to an increase of $19.7 billion of goodwill and an increase of other intangible assets of $20.3 billion, both related mainly to the Actavis acquisition.

Cash and investments at September 30, 2016 decreased to $2.7 billion, compared to $8.2 billion at June 30, 2016.

As of September 30, 2016, our debt was $36.9 billion, an increase of $26.0 billion compared to $10.9 billion as of June 30, 2016. The increase was mainly due to the $20.4 billion of debt issuances and the $5.0 billion term loans borrowed to finance the Actavis acquisition. The portion of total debt classified as short-term as of September 30, 2016 was 10%.

Total shareholders’ equity was $37.0 billion at September 30, 2016, compared to $32.0 billion at June 30, 2016.

Segment Results for the Third Quarter 2016

Generic Medicines Segment

   
Three Months Ended September 30,
2016   2015
U.S.$ in millions / % of Segment Revenues
   
Revenues $ 2,904 100.0% $ 2,202 100.0%
Gross profit 1,466 50.5% 1,005 45.6%
R&D expenses 184 6.3% 132 6.0%
S&M expenses 415 14.3% 295 13.4%
Segment profit* $ 867 29.9% $ 578 26.2%
 

* Segment profit consists of gross profit for the segment, less R&D and S&M expenses related to the segment. Segment profit does not include G&A expenses, amortization, inventory step-up and certain other items.

Generic Medicines Revenues

Generic medicines revenues in the third quarter of 2016 were $2.9 billion, an increase of 32% compared to the third quarter of 2015, reflecting the results of operations of the Actavis generics business from August 2, 2016. In local currency terms, revenues increased 35%.

Generic revenues consisted of:

  • U.S. revenues of $1.3 billion, an increase of 25% compared to the third quarter of 2015, mainly due to the inclusion the generic business of Actavis with revenues of $538 million.
  • European revenues of $829 million, an increase of 25%, or 31% in local currency terms, compared to the third quarter of 2015, mainly due to the inclusion the generic business of Actavis with revenues of $224 million.
  • ROW revenues of $782 million, an increase of 54%, or 60% in local currency terms, compared to the third quarter of 2015. The increase in local currency terms was mainly due to the results of our business venture with Takeda in Japan which commenced operations in April 2016 and $93 million in revenues from Actavis.
  • API sales to third parties of $191 million (which is included in the market revenues above), a decrease of 7%, compared to the third quarter of 2015, due to lower revenues in both Europe and the United States.

Generic medicines revenues comprised 52% of our total revenues in the quarter, compared to 46% in the third quarter of 2015.

Generic Medicines Gross Profit

Gross profit from our generic medicines segment in the third quarter of 2016 was $1.5 billion, an increase of 46% compared to the third quarter of 2015. The higher gross profit was mainly a result of the first time inclusion of the generic business of Actavis and our business venture with Takeda in Japan and higher gross profit of our API business as well as lower expenses related to production.

Gross profit margin for our generic medicines segment in the third quarter of 2016 increased to 50.5%, from 45.6% in the third quarter of 2015.

Generic Medicines Profit

Our generic medicines segment generated profit of $867 million in the third quarter of 2016, an increase of 50% compared to the third quarter of 2015. Generic medicines profitability as a percentage of generic medicines revenues was 29.9% in the third quarter of 2016, up from 26.2% in the third quarter of 2015.

Specialty Medicines Segment

   
Three Months Ended September 30,
2016   2015
U.S.$ in millions / % of Segment Revenues
   
Revenues $ 2,048 100.0% $ 2,178 100.0%
Gross profit 1,783 87.1% 1,859 85.4%
R&D expenses 228 11.1% 220 10.1%
S&M expenses 458 22.4% 417 19.1%
Segment profit* $ 1,097 53.6% $ 1,222 56.1%
 

* Segment profit consists of gross profit for the segment, less R&D and S&M expenses related to the segment. Segment profit does not include G&A expenses, amortization, inventory step-up and certain other items.

Specialty Medicines Revenues

Specialty medicines revenues in the third quarter of 2016 were $2.0 billion, a decrease of 6% compared to the third quarter of 2015. U.S. specialty medicines revenues were $1.6 billion, down 8% compared to the third quarter of 2015. European specialty medicines revenues were $406 million, an increase of 10%, or 12% in local currency terms, compared to the third quarter of 2015. ROW specialty revenues were $84 million, down 22%, or 20% in local currency terms, compared to the third quarter of 2015.

Specialty medicines revenues comprised 37% of our total revenues in the quarter, compared to 45% in the third quarter of 2015.

The decrease in specialty medicines revenues compared to the third quarter of 2015 was primarily due to lower revenues in all our core therapeutic areas.

The following table presents revenues by therapeutic area and key products for our specialty medicines segment for the three months ended September 30, 2016 and 2015:

       

Three Months Ended
September 30,

Percentage
Change

2016 2015 2016 - 2015
U.S. $ in millions
CNS $ 1,302 $ 1,366 (5%)
Copaxone® 1,061 1,085 (2%)
Azilect® 101 92 10%
Nuvigil® 21 97 (78%)
Respiratory 270 285 (5%)
ProAir® 118 149 (21%)
QVAR® 96 92 4%
Oncology 269 326 (17%)
Treanda® and Bendeka™ 149 207 (28%)
Women's Health 109 115 (5%)
Other Specialty   98   86 14%
Total Specialty Medicines $ 2,048 $ 2,178 (6%)
 

Global revenues of Copaxone® (20 mg/mL and 40 mg/mL), the leading multiple sclerosis therapy in the U.S. and globally, were $1.1 billion, a decrease of 2% compared to the third quarter of 2015.

Copaxone® revenues in the United States, were $874 million, flat compared to the third quarter of 2015, as a price increase of 7.9% in January 2016 was offset by a decrease in volume for Copaxone® 20 mg/mL. At the end of the third quarter of 2016, according to September 2016 IMS data, our U.S. market shares for the Copaxone® products in terms of new and total prescriptions were 27.0% and 29.2%, respectively. Copaxone® 40 mg/mL accounted for over 83% of total Copaxone® prescriptions in the U.S.

Copaxone® revenues outside the United States were $187 million, a decrease of 10%, or 8% in local currency terms, compared to the third quarter of 2015 mainly due to loss of tender orders in Russia, partially offset by an increase in volumes in Europe.

Our global Azilect® revenues were $101 million, an increase of 10% compared to the third quarter of 2015. Global in-market sales decreased 22% due to generic competition in certain European markets.

Revenues of our respiratory products were $270 million, down 5% compared to the third quarter of 2015. ProAir® revenues in the quarter were $118 million, down 21% compared to the third quarter of 2015, due to lower volumes related to changes in insurers’ preferred medicines lists. QVAR® global revenues were $96 million in the third quarter of 2016, up 4% compared to the third quarter of 2015, mainly due to higher volumes sold.

Revenues of our oncology products were $269 million in the third quarter of 2016, down 17% compared to the third quarter of 2015. Revenues of Treanda® and Bendeka™ were $149 million, down 28% compared to the third quarter of 2015, mainly due to lower volumes from normalization of channel inventory following the transition from Treanda® to BendekaTM in the first half of 2016 and competition from other therapies.

Specialty Medicines Gross Profit

Gross profit from our specialty medicines segment was $1.8 billion, down $76 million compared to the third quarter of 2015. Gross profit margin for our specialty medicines segment in the third quarter of 2016 was 87.1%, compared to 85.4% in the third quarter of 2015.

Specialty Medicines Profit

Our specialty medicines segment profit was $1.1 billion in the third quarter of 2016, down 10% compared to the third quarter of 2015, due to lower gross profit as well as increases in S&M and R&D expenses.

Specialty medicines profit as a percentage of segment revenues was 53.6% in the third quarter of 2016, down from 56.1% in the third quarter of 2015.

The following tables present details of our multiple sclerosis franchise and of our other specialty medicines for the three months ended September 30, 2016 and 2015:

   
Multiple Sclerosis
Three months ended September 30,
2016   2015
U.S.$ in millions / % of MS Revenues
   
Revenues $ 1,061 100.0% $ 1,085 100.0%
Gross profit 982 92.6% 980 90.3%
R&D expenses 20 1.9% 16 1.5%
S&M expenses   76   7.2%   88   8.1%
MS profit $ 886   83.5% $ 876   80.7%
 

Other Specialty

Three months ended September 30,
2016 2015
U.S.$ in millions / % of Other Specialty Revenues
   
Revenues $ 987 100.0% $ 1,093 100.0%
Gross profit 801 81.2% 879 80.4%
R&D expenses 208 21.1% 204 18.7%
S&M expenses   382   38.7%   329   30.1%
Other Specialty profit $ 211   21.4% $ 346   31.7%
 

Other Activities

Our OTC revenues related to PGT were $356 million, an increase of 40% compared to $255 million in the third quarter of 2015. In local currency terms, revenues increased 83%, mainly due to inflation in Venezuela. PGT’s in-market sales were $496 million in the third quarter of 2016, an increase of $115 million compared to the third quarter of 2015.

Other revenues were $255 million in the third quarter of 2016, mostly from the distribution of third-party products in Israel and Hungary, as well as from the contract manufacturing of products which were required to be divested in connection with the acquisition of Actavis, compared to revenues of $188 million in the third quarter of 2015. The increase was mainly due to revenues from contract manufacturing services of $32 million, as noted above, as well as to higher revenues from distribution in Israel.

Financial Outlook

  • We expect revenues for full year 2016 to be $21.6-$21.9 billion; we expect revenues for the fourth quarter of year 2016 to be $6.2-$6.5.
  • Non-GAAP EPS for 2016 is expected to be $5.10-$5.20, based on a weighted average number of shares of 1,020 million; non-GAAP EPS for the fourth quarter of 2016 is expected to be $1.34-$1.44, based on a weighted average number of shares of 1,077 million.
  • Cash flow from operating activities for 2016 is expected to be $4.8-$5.0 billion; cash flow from operating activities for the fourth quarter of 2016 is expected to be $1.0-$1.2 billion.

These estimates reflect management`s current expectations for Teva's performance in 2016. Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors. In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments and related tax effects.

Dividends

On November 14, 2016, the Board of Directors declared a cash dividend of $0.34 per ordinary share for the third quarter of 2016. For holders of our ordinary shares that are traded on the Tel Aviv Stock Exchange, the dividend will be converted into new Israeli shekels based on the official exchange rate as of November 15, 2016. The record date will be December 5, 2016, and the payment date will be December 20, 2016. Tax will be withheld at a rate of 15%.

On November 14, 2016, the Board of Directors also declared a cash dividend of $17.50 per Mandatory Convertible Preferred Share for the third quarter of 2016. The record date will be December 1, 2016, and the payment date will be December 15, 2016. Tax will be withheld at a rate of 15%.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Tuesday, November 15, 2016 at 8:00 a.m. ET. to discuss its third quarter 2016 results and overall business environment. A question & answer session will follow.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-966-1396; Canada 1-866-992-6802 or International +44(0) 2071 928000; passcode: 1843189. For a list of other international toll-free numbers, click here.

A live webcast of the call will also be available on Teva's website at: www.ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company's website. The replay can also be accessed until December 15, 2016, 9:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452 550000; passcode: 1843189.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 were $19.7 billion. For more information, visit www.tevapharm.com.

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This press release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and existing and potential generic versions); our ability to integrate Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”) and to realize the anticipated benefits of the acquisition (and the timing of realizing such benefits); the fact that following the consummation of the Actavis Generics acquisition, we are dependent to a much larger extent than previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional transactions or incur additional indebtedness as a result of the substantial amount of debt incurred to finance the Actavis Generics acquisition; the fact that for a period of time following the Actavis Generics acquisition, we will have significantly less cash on hand than previously, which could adversely affect our ability to grow; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from investments in our pipeline of specialty and other products; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC").

Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosures we make in our reports to the SEC on Form 6-K. Also note that we provide a cautionary discussion of risks and uncertainties under “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2015. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those listed could also adversely affect us. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.

   

Consolidated Statements of Income

(Unaudited, U.S. dollars in millions, except share and per share data)

         
Three months ended Nine months ended
September 30, September 30,
2016 2015 2016 2015
Net revenues 5,563 4,823 15,411 14,771
Cost of sales 2,762 2,052 6,942 6,262
Gross profit 2,801 2,771 8,469 8,509
Research and development expenses 663 361 1,427 1,079
Selling and marketing expenses 940 780 2,731 2,562
General and administrative expenses 310 316 925 948
Impairments, restructuring and others (410) 384 421 968
Legal settlements and loss contingencies 533 (80) 674 531
Operating income 765 1,010 2,291 2,421
Financial expenses – net 150 697 553 930
Income before income taxes 615 313 1,738 1,491
Income taxes 207 193 464 385
Share in (profits) losses of associated companies – net (2) 4 (11) 7
Net income 410 116 1,285 1,099
Net income (loss) attributable to non-controlling interests (2) 13 (17) 11
Net income attributable to Teva 412 103 1,302 1,088
Dividends on preferred shares 64 - 196 -
Net income attributable to ordinary shareholders 348 103 1,106 1,088
                         
Earnings per share attributable to ordinary shareholders: Basic ($) 0.35 0.12 1.18 1.28
Diluted ($) 0.35 0.12 1.17 1.26
Weighted average number of shares (in millions): Basic 979 851 935 851
Diluted 984 862 942 860
                         
                         
Non-GAAP net income attributable to ordinary shareholders:* 1,300 1,165 3,568 3,560
Non-GAAP net income attributable to ordinary shareholders for diluted earnings per share:** 1,364 1,165 3,764 3,560
 
Non-GAAP earnings per share attributable to ordinary shareholders:* Basic ($) 1.33 1.37 3.81 4.18
Diluted ($)** 1.31 1.35 3.76 4.14
 
Non-GAAP average number of shares (in millions): Basic 979 851 935 851
Diluted 1,044 862 1,001 860
 

* See reconciliation attached.

**Dividends on the mandatory convertible preferred shares of $196 and $64 million for the nine and three months ended September 30, 2016, respectively, are added back to non-GAAP net income attributable to ordinary shareholders, since such preferred shares had a dilutive effect on non-GAAP earnings per share.

 

Condensed Consolidated Balance Sheets

(U.S. dollars in millions)

(Unaudited)

     
September 30, December 31,
2016 2015
ASSETS
Current assets:
Cash and cash equivalents 1,557 6,946
Accounts receivable 8,071 5,350
Inventories 5,349 3,966
Deferred income taxes - 735
Assets held for sale 1,057 -
Other current assets 1,352 1,401
Total current assets 17,386 18,398
Deferred income taxes 1,065 250
Other non-current assets 2,064 2,341
Property, plant and equipment, net 8,379 6,544
Identifiable intangible assets, net 29,557 7,675
Goodwill 40,296 19,025
Total assets 98,747 54,233
 
LIABILITIES AND EQUITY
Current liabilities:
Short-term debt 3,676 1,585
Sales reserves and allowances 7,797 6,601
Accounts payable and accruals 4,953 3,594
Liabilities held for sale 327 -
Other current liabilities 2,533 1,225
Total current liabilities 19,286 13,005
 
 
Long-term liabilities:
Deferred income taxes 7,862 1,748
Other taxes and long-term liabilities 1,392 1,195
Senior notes and loans 33,179 8,358
Total long-term liabilities 42,433 11,301
Equity:
Teva shareholders’ equity 35,129 29,769
Non-controlling interests 1,899 158
Total equity 37,028 29,927
Total liabilities and equity 98,747 54,233
 

 

Condensed Consolidated Cash Flow

(Unaudited, U.S. Dollars in millions)

         
Three months ended

 

Nine months ended

September 30,

September 30,

2016 2015 2016 2015
Operating activities:
Net income 410 116 1,285 1,099
Net change in operating assets and liabilities 1,047 (463) 1,100 703
Items not involving cash flow 4 1,440 1,415 2,125
       
Net cash provided by operating activities 1,461 1,093 3,800 3,927
 
Net cash used in investing activities (32,301) (136) (34,943) (5,272)
 
Net cash provided by (used in) financing activities 25,372 (1,090) 25,918 90
 
Translation adjustment on cash and cash equivalents 41 (7) (164) (43)
       
Net change in cash and cash equivalents (5,427) (140) (5,389) (1,298)
 
Balance of cash and cash equivalents at beginning of period 6,984 1,068 6,946 2,226
       
Balance of cash and cash equivalents at end of period 1,557 928 1,557 928
 

 

Non GAAP reconciliation items

(Unaudited, U.S. Dollars in millions)

         
Three months ended Nine months ended
September 30, September 30,
2016 2015 2016 2015
Gain on sales of business and long-lived assets (693) - (693) -
Legal settlements and loss contingencies 533 (80) 674 531
Amortization of purchased intangible assets 429 203 811 637
Acquisition and related expenses 337 61 449 218
Inventory step-up 152 - 243 -
Restructuring expenses 115 70 154 121
Costs related to regulatory actions taken in facilities 46 9 123 28
Contingent consideration 34 67 85 329
Equity compensation expenses 31 24 83 82
Impairment of long-lived assets 29 187 614 334
Other non-GAAP items 16 (1) 19 (8)
Other write-offs associated with the impairment of Zecuity® - - 53 -
Financial expense (income) (1) 632 344 775
Minority interest (22) 16 (65) 16
Corresponding tax benefit (54) (126) (432) (591)
 

 

Reconciliation between net income attributable to ordinary shareholders and earnings per share

as reported under US GAAP to non-GAAP net income attributable to ordinary shareholders and earnings per share

                   
Three months ended September 30, 2016 Three months ended September 30, 2015
U.S. dollars and shares in millions (except per share amounts)
GAAP

Non-GAAP
Adjustments

Dividends on
Preferred
Shares

Non-GAAP

% of Net
Revenues

GAAP

Non-GAAP
Adjustments

Non-GAAP

% of Net
Revenues

 
Gross profit (1) 2,801 592 - 3,393 61% 2,771 208 2,979 62%
Operating income (1)(2) 765 1,029 - 1,794 32% 1,010 540 1,550 32%
Net income attributable to ordinary shareholders (1)(2)(3)(4) 348 952 64 1,364 25% 103 1,062 1,165 24%
Earnings per share attributable to ordinary shareholders - diluted (5) 0.35 0.96 - 1.31 0.12 1.23 1.35
 
 
(1) Amortization of purchased intangible assets 387 196
Costs related to regulatory actions taken in facilities 46 9
Equity compensation expenses 4 3
Other COGS related adjustments 155 -
Gross profit adjustments 592 208
Gross profit adjustments
 
(2) Legal settlements and loss contingencies 533 (80)
Contingent consideration 34 67
Acquisition and related expenses 337 61
Equity compensation expenses 27 21
Restructuring expenses 115 70
Impairment of long-lived assets 29 187
Amortization of purchased intangible assets 42 7
Gain on sales of business and long-lived assets (693) -
Other operating related adjustments 13 (1)
437 332
Operating income adjustments 1,029 540
(3) Financial expense (income) (1) 632
Tax effect (54) (126)
Minority interest (22) 16
Net income adjustments 952 1,062
 
(4)   Dividends on the mandatory convertible preferred shares of $64 million for the three months ended September 30, 2016 are added back to non-GAAP net income attributable to ordinary shareholders, since such preferred shares had a dilutive effect on non-GAAP earnings per share, as described in the following footnote.
 
(5) The non-GAAP weighted average number of shares was 1,044 and 862 million for the three months ended September 30, 2016 and 2015, respectively. The non-GAAP weighted average number of shares for the three months ended September 30, 2016 takes into account the potential dilution of the mandatory convertible preferred shares (amounting to 59 million weighted average shares), which had a dilutive effect on non-GAAP earnings per share. Non-GAAP earnings per share can be reconciled with GAAP earnings per share by dividing each of the amounts included in footnotes 1-4 above by the applicable weighted average share number.
 

 

Reconciliation between net income attributable to ordinary shareholders and earnings per share

as reported under US GAAP to non-GAAP net income attributable to ordinary shareholders and earnings per share

                     
Nine months ended September 30, 2016 Nine months ended September 30, 2015
U.S. dollars and shares in millions (except per share amounts)
GAAP

Non-GAAP
Adjustments

Dividends on
Preferred
Shares

Non-
GAAP

% of Net
Revenues

GAAP

Non-GAAP
Adjustments

Non-
GAAP

% of Net
Revenues

 
Gross profit (1) 8,469 1,090 - 9,559 62% 8,509 652 9,161 62%
Operating income (1)(2) 2,291 2,612 - 4,903 32% 2,421 2,272 4,693 32%
Net income attributable to ordinary shareholders (1)(2)(3)(4) 1,106 2,462 196 3,764 24% 1,088 2,472 3,560 24%
Earnings per share attributable to ordinary shareholders - diluted (5) 1.17 2.59 3.76 1.26 2.88 4.14
 
 
(1) Amortization of purchased intangible assets 711 614
Costs related to regulatory actions taken in facilities 123 28
Equity compensation expenses 10 8
Other COGS related adjustments 246 2
Gross profit adjustments 1,090 652
 
(2) Legal settlements and loss contingencies 674 531
Contingent consideration 85 329
Acquisition and related expenses 446 218
Equity compensation expenses 73 74
Restructuring expenses 154 121
Impairment of long-lived assets 614 334
Amortization of purchased intangible assets 100 23
Gain on sales of business and long-lived assets (693) -
Other operating related expenses (income) 69 (10)
 
1,522 1,620
Operating income adjustments 2,612 2,272
(3) Financial expense 344 775
Tax effect (432) (591)
Impairment of equity investment—net 3 -
Minority interest (65) 16
 
Net income adjustments 2,462 2,472
 
(4)   Dividends on the mandatory convertible preferred shares of $196 million for the nine months ended September 30, 2016 are added to non-GAAP net income attributable to ordinary shareholders, since such preferred shares had a dilutive effect on non-GAAP earnings per share, as described in the following footnote.
 
(5) The non-GAAP weighted average number of shares was 1,001 and 860 million for the nine months ended September 30, 2016 and 2015, respectively. The non-GAAP weighted average number of shares for the nine months ended September 30, 2016 takes into account the potential dilution of the mandatory convertible preferred shares (amounting to 59 million weighted average shares), which had a dilutive effect on non-GAAP earnings per share. Non-GAAP earnings per share can be reconciled with GAAP earnings per share by dividing each of the amounts included in footnotes 1-4 above by the applicable weighted average share number.
 

 
Segment Information
           
Generics
Three months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of Segment Revenues
 
Revenues $ 2,904 100% $ 2,202 100.0% 32%
Gross Profit 1,466 50.5% 1,005 45.6% 46%
R&D Expenses 184 6.3% 132 6.0% 39%
S&M Expenses   415   14.3%   295   13.4% 41%
Segment Profit* $ 867   29.9% $ 578   26.2% 50%
 
Specialty
Three months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of Segment Revenues
 
Revenues $ 2,048 100% $ 2,178 100.0% (6%)
Gross Profit 1,783 87.1% 1,859 85.4% (4%)
R&D Expenses 228 11.1% 220 10.1% 4%
S&M Expenses   458   22.4%   417   19.2% 10%
Segment Profit* $ 1,097   53.6% $ 1,222   56.1% (10%)
 

* Segment profit consists of gross profit, less S&M and R&D expenses related to the segment. Segment profit does not include G&A expenses, amortization, inventory step-up and certain other items.

 
Segment Information
 
    Generics
Nine months ended September 30,   Percentage Change
2016   2015 2016 - 2015
U.S.$ in millions / % of Segment Revenues
   
Revenues $ 7,368 100.0% $ 7,289 100.0% 1%
Gross Profit 3,537 48.0% 3,487 47.8% 1%
R&D Expenses 445 6.1% 377 5.1% 18%
S&M Expenses   1,027   13.9%   1,004   13.8% 2%
Segment Profit* $ 2,065   28.0% $ 2,106   28.9% (2%)
 
Specialty
Nine months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of Segment Revenues
 
Revenues $ 6,471 100.0% $ 6,224 100.0% 4%
Gross Profit 5,632 87.0% 5,345 85.9% 5%
R&D Expenses 702 10.8% 655 10.5% 7%
S&M Expenses   1,393   21.5%   1,360   21.9% 2%
Segment Profit* $ 3,537   54.7% $ 3,330   53.5% 6%
 

* Segment profit consists of gross profit, less S&M and R&D expenses related to the segment. Segment profit does not include G&A expenses, amortization, inventory step-up and certain other items.

 
Additional information
           
Multiple Sclerosis
Three months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of MS Revenues
 
Revenues $ 1,061 100.0% $ 1,085 100.0% (2%)
Gross profit 982 92.6% 980 90.3% 0%
R&D expenses 20 1.9% 16 1.5% 25%
S&M expenses   76   7.2%   88   8.1% (14%)
MS profit $ 886   83.5% $ 876   80.7% 1%
 
 
Other Specialty  
Three months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of Other Specialty Revenues
 
Revenues $ 987 100.0% $ 1,093 100.0% (10%)
Gross profit 801 81.2% 879 80.4% (9%)
R&D expenses 208 21.1% 204 18.6% 2%
S&M expenses   382   38.7%   329   30.1% 16%
Other Specialty profit $ 211   21.4% $ 346   31.7% (39%)
 

 
Additional information
           
Multiple Sclerosis
Nine months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of MS Revenues
 
Revenues $ 3,208 100.0% $ 3,063 100.0% 5%
Gross profit 2,930 91.3% 2,752 89.8% 6%
R&D expenses 65 2.0% 69 2.3% (6%)
S&M expenses   246   7.7%   311   10.1% (21%)
MS profit $ 2,619   81.6% $ 2,372   77.4% 10%
 
 
Other Specialty    
Nine months ended September 30, Percentage Change
2016 2015 2016 - 2015
U.S.$ in millions / % of Other Specialty Revenues
 
Revenues $ 3,263 100.0% $ 3,161 100.0% 3%
Gross profit 2,702 82.8% 2,593 82.0% 4%
R&D expenses 637 19.5% 586 18.5% 9%
S&M expenses   1,147   35.2%   1,049   33.2% 9%
Other Specialty profit $ 918   28.1% $ 958   30.3% (4%)
 

 
Reconciliation of our segment profit
to Teva's consolidated income before income taxes
         
Three months ended September 30,
2016 2015
U.S.$ in millions
Generic medicines profit $ 867 $ 578
Specialty medicines profit   1,097   1,222
Total segment profit 1,964 1,800
Profit of other activities   134   58
Total profit 2,098 1,858
Amounts not allocated to segments:
Amortization 429 203
General and administrative expenses 310 316
Impairments, restructuring and others (410) 384
Legal settlements and loss contingencies 533 (80)
Other unallocated amounts 471 25
       
Consolidated operating income   765   1,010
Financial expenses - net   150   697
Consolidated income before income taxes $ 615 $ 313
 

 
Reconciliation of our segment profit
to Teva's consolidated income before income taxes
         
Nine months ended September 30,
2016 2015
U.S.$ in millions
Generic medicines profit $ 2,065 $ 2,106
Specialty medicines profit   3,537   3,330
Total segment profit 5,602 5,436
Profit of other activities   198   164
Total profit 5,800 5,600
Amounts not allocated to segments:
Amortization 811 637
General and administrative expenses 925 948
Impairments, restructuring and others 421 968
Legal settlements and loss contingencies 674 531
Other unallocated amounts 678 95
       
Consolidated operating income   2,291   2,421
Financial expenses - net   553   930
Consolidated income before income taxes $ 1,738 $ 1,491
 

Revenues by Activity and Geographical Area
(Unaudited)
           

Three Months Ended
September 30,

Percentage
Change

Percentage
Change

2016 2015 2016 - 2015 2016 - 2015
U.S. $ in millions

in local
currencies

Generic Medicines
United States $ 1,293 $ 1,032 25% 25%
Europe* 829 661 25% 31%
Rest of the World   782   509 54% 60%
Total Generic Medicines 2,904 2,202 32% 35%
Specialty Medicines
United States 1,558 1,701 (8%) (8%)
Europe* 406 369 10% 12%
Rest of the World   84   108 (22%) (20%)
Total Specialty Medicines 2,048 2,178 (6%) (6%)
Other Revenues
United States 12 1 1100% 1100%
Europe* 175 169 4% 4%
Rest of the World   424   273 55% 95%
Total Other Revenues   611   443 38% 62%
Total Revenues $ 5,563 $ 4,823 15% 19%
 

* All members of the European Union, Switzerland, Norway, Albania, Iceland and the countries of former Yugoslavia.

 
Revenues by Activity and Geographical Area
(Unaudited)
   

Nine Months Ended
September 30,

Percentage
Change

 

Percentage
Change

2016     2015 2016 - 2015 2016 - 2015
U.S. $ in millions

in local
currencies

Generic Medicines
United States $ 3,161 $ 3,797 (17%) (17%)
Europe* 2,160 2,006 8% 10%
Rest of the World 2,047 1,486 38% 47%
Total Generic Medicines 7,368 7,289 1% 4%
Specialty Medicines
United States 5,007 4,802 4% 4%
Europe* 1,214 1,152 5% 7%
Rest of the World 250 270 (7%) 1%
Total Specialty 6,471 6,224 4% 5%
Other Revenues
United States 19 8 138% 138%
Europe* 510 508 0% 1%
Rest of the World 1,043   742 41% 67%
Total Other Revenues 1,572 1,258 25% 41%
Total Revenues $ 15,411 $ 14,771 4% 7%
 

* All members of the European Union, Switzerland, Norway, Albania, Iceland and the countries of former Yugoslavia.

 
Revenues by Product line
(Unaudited)
       

Three Months Ended
September 30,

Percentage
Change

2016 2015 2016 - 2015
U.S. $ in millions
 
Generic Medicines $ 2,904 $ 2,202 32%
API 191 206 (7%)
Specialty Medicines 2,048 2,178 (6%)
CNS 1,302 1,366 (5%)
Copaxone® 1,061 1,085 (2%)
Azilect® 101 92 10%
Nuvigil® 21 97 (78%)
Respiratory 270 285 (5%)
ProAir® 118 149 (21%)
QVAR® 96 92 4%
Oncology 269 326 (17%)
Treanda® and Bendeka™ 149 207 (28%)
Women's Health 109 115 (5%)
Other Specialty 98 86 14%
All Others 611 443 38%
OTC 356 255 40%
Other Revenues   255   188 36%
Total $ 5,563 $ 4,823 15%
 

 
Revenues by Product line
(Unaudited)
       

Nine Months Ended
September 30,

Percentage
Change

2016 2015 2016 - 2015
U.S. $ in millions
 
Generic Medicines $ 7,368 $ 7,289 1%
API 595 546 9%
Specialty Medicines 6,471 6,224 4%
CNS 4,040 3,939 3%
Copaxone® 3,208 3,063 5%
Azilect® 322 304 6%
Nuvigil® 175 273 (36%)
Respiratory 949 803 18%
ProAir® 426 401 6%
QVAR® 346 273 27%
Oncology 871 883 (1%)
Treanda® and Bendeka™ 511 543 (6%)
Women's Health 336 354 (5%)
Other Specialty 275 245 12%
All Others 1,572 1,258 25%
OTC 906 678 34%
Other Revenues   666   580 15%
Total $ 15,411 $ 14,771 4%
 

Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris Beck Codner, 972 (3) 926-7246
or
United States
Denise Bradley, 215-591-8974