0001157523-22-000164.txt : 20220209 0001157523-22-000164.hdr.sgml : 20220209 20220209070039 ACCESSION NUMBER: 0001157523-22-000164 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20220209 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220209 DATE AS OF CHANGE: 20220209 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TEVA PHARMACEUTICAL INDUSTRIES LTD CENTRAL INDEX KEY: 0000818686 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: L3 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-16174 FILM NUMBER: 22603766 BUSINESS ADDRESS: STREET 1: 5 BAZEL ST STREET 2: P O B 3190 CITY: PETACH TIKVA STATE: L3 ZIP: 49131 BUSINESS PHONE: 9729267267 MAIL ADDRESS: STREET 1: TEVA PHARMACEUTICAL INDUSTRIES LIMITED STREET 2: 5 BAZEL ST PO B 3190 CITY: PETACH TIKVA STATE: L3 ZIP: 49131 8-K 1 a52576299.htm TEVA PHARMACEUTICAL INDUSTRIES LIMITED 8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 

 
FORM 8-K
 


CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported) February 9, 2022
 

 
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
(Exact name of registrant as specified in its charter)
 

 
Israel
 
001-16174
 
00-0000000
(State or Other Jurisdiction
 
(Commission
 
(IRS Employer
of Incorporation)
 
File Number)
 
Identification No.)
 
124 Dvora Hanevi’a Street
Tel Aviv 6944020, Israel
(Address of Principal Executive Offices, including Zip Code)
 
+972-3-914-8213
(Registrant’s Telephone Number, including Area Code)
 
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
 

 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:

Title of each class
  Trading Symbol(s)
  Name of each exchange on which registered
American Depositary Shares, each representing one Ordinary Share
  TEVA
  New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging Growth Company         
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.      ☐



ITEM 2.02
Results of Operations and Financial Condition

On February 9, 2022, Teva Pharmaceutical Industries Ltd. issued a press release announcing its financial results for the period ended December 31, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and the information contained therein is incorporated herein by reference.

The information included in this Item 2.02 is being furnished to the Securities and Exchange Commission and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

ITEM 9.01
Financial Statements and Exhibits
(d) Exhibits

Exhibit
No.
 
Description of Document
 




SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  TEVA PHARMACEUTICAL INDUSTRIES LIMITED 
    
        
Date: February 9, 2022
By:
 /s/ Eli Kalif  
    Name: Eli Kalif  
    Title: Executive Vice President,  
     
Chief Financial Officer
EX-99.1 2 a52576299ex99_1.htm EXHIBIT 99.1
 
 Exhibit 99.1

Teva Reports Fourth Quarter and Full Year 2021 Financial Results

TEL AVIV, Israel--(BUSINESS WIRE)--February 9, 2022--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today reported results for the year and the quarter ended December 31, 2021.

  • Q4 2021 and FY 2021 highlights:

 

Q4 2021


FY 2021





 

Revenues

 

$4.1 billion


$15.9 billion

GAAP diluted EPS

 

$(0.14)


$0.38

Non-GAAP diluted EPS

 

$0.77


$2.58

Cash flow generated from operating activities

 

$456 million


$798 million

Free cash flow

 

$716 million


$2,196 million

  • 2022 business outlook:
    • Revenues are expected to be $15.6 - $16.2 billion
    • Non-GAAP diluted EPS is expected to be $2.40 - $2.60
    • Free cash flow is expected to be $1.9 - $2.2 billion

"In 2021 Teva delivered solid results, generating strong cash flow and improving our profitability. While COVID-19 continued to impact patient behavior and global prescribing patterns, we continued to optimize our supply chain and manufacturing capabilities to provide essential medicines to the millions of patients who rely on us throughout the world. We improved our gross and operating margin and reduced our net debt, keeping us on our path to achieve our 2023 long-term goals", said Mr. Kåre Schultz, Teva’s President and CEO.

Mr. Schultz continued: "Looking forward to 2022, we expect to see continued growth of our key products AUSTEDO® and AJOVY®, as well as to continue to advance our core business through the launch of high quality generic medicines around the world. We are also excited about the expected FDA approval and launch of Risperidone LAI, an important treatment for patients suffering from schizophrenia.

Regarding the recently announced settlement in the opioid-related litigation in Texas, Mr. Schultz stated, "I'm very pleased with the agreement we reached with the state of Texas, the second most populous state in the U.S. Not only does it mark a further step in resolving our legacy opioids litigations more broadly, but importantly also makes critical medicines part of the solution when addressing the opioids epidemic. While the agreement includes no admission of wrongdoing, it remains in our best interest to put these cases behind us and continue to focus on the patients we serve every day.”


2021 Annual Consolidated Results

Revenues in 2021 were $15,878 million, a decrease of 5%, in U.S. dollars or 6% in local currency terms, compared to 2020, mainly due to lower revenues from COPAXONE®, generic products in the U.S., generic products in Japan resulting from the divestment of a majority of the generic and operational assets of our Japanese business venture and Anda, partially offset by higher revenues from AUSTEDO and AJOVY. Revenues continued to be affected by the ongoing impact of the COVID-19 pandemic on markets and on customer stocking and purchasing patterns.

Exchange rate movements during 2021, including hedging effects, positively impacted revenues by $232 million, GAAP operating income by $49 million and non-GAAP operating income by $55 million, each as compared to 2021.

GAAP gross profit was $7,594 million in 2021, a decrease of 2% compared to 2020. GAAP gross profit margin was 47.8% in 2021, compared to 46.4% in 2020. Non-GAAP gross profit was $8,612 million in 2021, a decrease of 1% compared to 2020. Non-GAAP gross profit margin was 54.2% in 2021, compared to 52.4% in 2020. This increase in both GAAP and non-GAAP gross profit as a percentage of revenues was mainly due to higher profitability in North America, resulting from higher revenues from AUSTEDO and AJOVY and a favorable mix of generic products, as well as higher profitability in Europe and International Markets, partially offset by lower revenues from COPAXONE due to generic competition.

GAAP Research and Development (R&D) expenses in 2021 were $967 million, a decrease of 3% compared to 2020. Non-GAAP R&D expenses in 2021 were $933 million, or 5.9% of revenues, compared to $941 million, or 5.6% of revenues, in 2020. The decrease in non-GAAP R&D expenses in 2021, compared to 2020, was mainly due to a decrease in the pain and neuropsychiatry therapeutic areas, partially offset by higher R&D expenses related to generic products including biosimilars.

GAAP Selling and Marketing (S&M) expenses in 2021 were $2,429 million, a decrease of 3% compared to 2020. Non-GAAP S&M expenses were $2,297 million, or 14.5% of revenues, in 2021, compared to $2,322 million, or 13.9% of revenues, in 2020.

GAAP General and Administrative (G&A) expenses in 2021 were $1,099 million, a decrease of 6% compared to 2020. Non-GAAP G&A expenses were $1,029 million in 2021, or 6.5% of revenues, compared to $1,115 million, or 6.7% of revenues, in 2020.

GAAP other income in 2021 was $98 million, compared to $40 million in 2020. Non-GAAP other income in 2021 was $48 million, compared to $31 million in 2020.


GAAP operating income was $1,716 million in 2021, compared to an operating loss of $3,572 million in 2020. GAAP operating loss in 2020 was mainly affected by goodwill impairment charges and intangible asset impairments. Non-GAAP operating income was $4,401 million in 2021, or 27.7% of revenues compared to $4,388 million, or 26.3% of revenues in 2020.

EBITDA (defined as operating income, excluding amortization and depreciation expenses) was $3,046 million in 2021, compared to negative EBITDA of $2,007 million in 2020. Adjusted EBITDA (defined as non-GAAP operating income excluding depreciation expenses) was $4,911 million in 2021, compared to $4,912 million in 2020.

In 2021, GAAP financial expenses were $1,058 million, compared to $834 million in 2020. Non-GAAP financial expenses were $930 million in 2021, compared to $918 million in 2020.

In 2021, we recognized a GAAP tax expense of $211 million, or 32%, on a pre-tax income of $658 million. In 2020, we recognized a tax benefit of $168 million, or 4%, on a pre-tax loss of $4,406 million. Our tax rate for 2020 was lower than in 2021 mainly due to a goodwill impairment charge that did not have a corresponding tax effect. Non-GAAP income taxes for 2021 were $570 million on non-GAAP pre-tax income of $3,471 million. Non-GAAP income taxes in 2020 were $577 million on non-GAAP pre-tax income of $3,470 million. The non-GAAP tax rate for 2021 was 16.4%, similar to 16.6% in 2020.

GAAP net income attributable to Teva and GAAP diluted earnings per share in 2021 were $417 million and $0.38, respectively, compared to net loss of $3,990 million and diluted loss per share of $3.64 in 2020. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in 2021 were $2,855 million and $2.58, respectively, compared to $2,830 million and $2.57 in 2020.

The weighted average diluted shares outstanding used for the fully diluted share calculation on a GAAP basis for 2021 and 2020 were 1,107 million and 1,095 million shares, respectively. The weighted average diluted outstanding shares used for the fully diluted earnings per share calculation on a non-GAAP basis for 2021 and 2020 were 1,107 million and 1,099 million shares, respectively.

As of December 31, 2021 and 2020, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,128 million and 1,117 million shares, respectively.


Non-GAAP information: Net non-GAAP adjustments in 2021 were $2,438 million. Non-GAAP net income and non-GAAP EPS for the year were adjusted to exclude the following items:

  • Amortization of purchased intangible assets totaling $802 million, of which $702 million is included in cost of goods sold and the remaining $99 million in S&M expenses;
  • Legal settlements and loss contingencies of $717 million;
  • $584 million impairment of long-lived assets comprised mainly of impairments of identifiable intangible assets totaling $424 million ($297 million of product rights and trade names and $127 million of in process R&D assets) and tangible assets impairments in our Europe and North America segments;
  • Restructuring expenses of $133 million;
  • Financial expenses of $128 million, mainly related to revaluation of marketable securities;
  • Equity compensation expenses of $118 million;
  • Costs related to regulatory actions taken in facilities of $23 million;
  • Purchase of in process R&D of $15 million;
  • Contingent consideration expense of $7 million;
  • Divested gain in amount of $51 million;
  • Other non-GAAP items of $337 million;
  • Minority interest adjustment of $15 million; and
  • Related tax effect of $360 million.

Teva believes that excluding such items facilitates investors’ understanding of its business. For further information, see below the U.S. GAAP to adjusted non-GAAP reconciliation tables under “Financial Tables” 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 2021 was $798 million, compared to $1,216 million in 2020. This decrease was mainly due to lower profit in our North America segment during 2021.

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 $2,196 million in 2021, compared to $2,110 million in 2020. The increase in 2021 resulted mainly from higher cash generated from divestitures of businesses and other assets, partially offset by lower cash flow generated from operating activities.


As of December 31, 2021, our debt was $23,043 million, compared to $25,919 million as of December 31, 2020. This decrease was mainly due to $4,008 million repurchased upon consummation of a cash tender offer, $3,167 million senior notes repaid at maturity and $710 million of exchange rate fluctuations, partially offset by $4,973 million of issued sustainability-linked senior notes net of issuance costs. The portion of total debt classified as short-term as of December 31, 2021 was 6%, compared to 12% as of December 31, 2020, due to a repayment of debt, partially offset by a reclassification of upcoming maturities in 2022. Our average debt maturity was approximately 6.4 years as of December 31, 2021, compared to 5.8 years as of December 31, 2020.

Fourth Quarter 2021 Consolidated Results

Revenues in the fourth quarter of 2021 were $4,100 million, a decrease of 8% in both U.S. dollars and local currency terms compared to the fourth quarter of 2020, mainly due to lower revenues from generic products in North America and COPAXONE, partially offset by higher revenues from AUSTEDO and AJOVY. Revenues continued to be affected by the ongoing impact of the COVID-19 pandemic on markets and on customer stocking and purchasing patterns.

Exchange rate differences between the fourth quarter of 2021 and the fourth quarter of 2020, net of hedging effects negatively impacted revenues by $19 million and positively impacted our GAAP operating income by $15 million. Our non-GAAP operating income was positively impacted by $12 million.

GAAP gross profit was $2,050 million in the fourth quarter of 2021, flat compared to the fourth quarter of 2020. GAAP gross profit margin was 50% in the fourth quarter of 2021, compared to 46% in the fourth quarter of 2020. Non-GAAP gross profit was $2,301 million in the fourth quarter of 2021, a decrease of 1% compared to the fourth quarter of 2020. Non-GAAP gross profit margin was 56.1% in the fourth quarter of 2021, compared to 52.3% in the fourth quarter of 2020. The increase in non-GAAP gross profit margin in the fourth quarter of 2021 resulted mainly from higher revenues from AUSTEDO and AJOVY, higher gross profit margin in our Europe and International Markets segments, partially offset by lower revenues from COPAXONE in North America due to generic competition.

GAAP Research and Development (R&D) expenses in the fourth quarter of 2021 were $244 million, a decrease of 17% compared to the fourth quarter of 2020. Non-GAAP R&D expenses were $229 million, or 5.6% of quarterly revenues, in the fourth quarter of 2021, compared to $254 million, or 5.7% of quarterly revenues, in the fourth quarter of 2020. The decrease in R&D expenses in the fourth quarter of 2021 was mainly due to a decrease in the pain and neuropsychiatry therapeutic areas, partially offset by higher R&D expenses related to generic products including biosimilars.

GAAP Selling and Marketing (S&M) expenses in the fourth quarter of 2021 were $632 million, a decrease of 7% compared to the fourth quarter of 2020. Non-GAAP S&M expenses were $600 million, or 14.6% of quarterly revenues in the fourth quarter of 2021, compared to $627 million, or 14.1% of quarterly revenues in the fourth quarter of 2020.


GAAP General and Administrative (G&A) expenses in the fourth quarter of 2021 were $276 million, a decrease of 15% compared to the fourth quarter of 2020. Non-GAAP G&A expenses were $244 million, or 6% of quarterly revenues in the fourth quarter of 2021, compared to $312 million, or 7% of quarterly revenues in the fourth quarter of 2020.

GAAP other income in the fourth quarter of 2021 was $26 million, compared to $10 million in the fourth quarter of 2020. Non-GAAP other income in the fourth quarter of 2021 was $19 million, compared to $5 million in the fourth quarter of 2020.

GAAP operating income in the fourth quarter of 2021 was $78 million, compared to $406 million in the fourth quarter of 2020. This decrease was mainly due to higher legal settlements and loss contingencies in the fourth quarter of 2021. Non-GAAP operating income in the fourth quarter of 2021 was $1,248 million, an increase of 9% compared to the fourth quarter of 2020.

EBITDA (defined as operating income, excluding amortization and depreciation expenses) was $397 million in the fourth quarter of 2021, compared to EBITDA of $808 million in the fourth quarter of 2020. Adjusted EBITDA (defined as non-GAAP operating income excluding depreciation expenses) was $1,373 million in the fourth of 2021, an increase of 8%, compared to $1,277 million in the fourth quarter of 2020.

GAAP financial expenses for the fourth quarter of 2021 were $253 million, compared to $268 million in the fourth quarter of 2020. Non-GAAP financial expenses were $229 million in the fourth quarter of 2021, compared to $235 million in the fourth quarter of 2020. Financial expenses in the fourth quarter of 2021 and 2020, were mainly comprised of interest expenses of $225 million and $224 million, respectively.

In the fourth quarter of 2021, we recognized a GAAP tax benefit of $24 million on a pre-tax GAAP loss of $175 million. In the fourth quarter of 2020, we recognized a GAAP tax benefit of $22 million on pre-tax GAAP income of $138 million. Non-GAAP income taxes for the fourth quarter of 2021 were $153 million, or 15%, on pre-tax non-GAAP income of $1,019 million. Non-GAAP income taxes in the fourth quarter of 2020 were $141 million, or 16%, on pre-tax non-GAAP income of $905 million.

GAAP net loss attributable to Teva and GAAP diluted loss per share in the fourth quarter of 2021 were $159 million and $0.14, respectively, compared to GAAP net income attributable to Teva and GAAP diluted earnings per share of $150 million and $0.14, respectively, in the fourth quarter of 2020. Non-GAAP net income attributable to Teva and non-GAAP diluted earnings per share in the fourth quarter of 2021 were $854 million and $0.77, respectively, compared to $753 million and $0.68, respectively, in the fourth quarter of 2020.

The weighted average diluted shares outstanding used for the fully diluted share calculation for the three months ended December 31, 2021 and 2020 was 1,103 million shares and 1,100 million shares, respectively. The weighted average diluted shares outstanding used for the fully diluted share calculation on a non-GAAP basis for the three months ended December 31, 2021 and 2020 was 1,108 million and 1,100 million shares, respectively.


Non-GAAP information: Net non-GAAP adjustments in the fourth quarter of 2021 were $1,012 million. Non-GAAP net income and non-GAAP EPS for the fourth quarter were adjusted to exclude the following items:

  • Legal settlements and loss contingencies of $604 million;
  • Amortization of purchased intangible assets of $188 million, of which $165 million is included in cost of sales and the remaining $24 million in S&M expenses;
  • $183 million impairment of long-lived assets comprised of impairments of identifiable intangible assets totaling $129 million and $54 million of tangible assets;
  • Restructuring expenses of $37 million;
  • Finance expenses of $25 million;
  • Contingent consideration of $14 million;
  • Purchase of in process R&D of $10 million;
  • Equity compensation expenses of $32 million;
  • Costs related to regulatory actions taken in facilities of $5 million;
  • Divested gain in amount of $5 million;
  • Minority interest adjustment of $5 million;
  • Other non-GAAP items of $103 million; and
  • Related tax effect of $178 million.

Teva believes that excluding such items facilitates investors' understanding of its business. For further information, see below the U.S. GAAP to adjusted non-GAAP reconciliation tables under “Financial Tables” 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 during the fourth quarter of 2021 was $456 million, compared to $331 million in the fourth quarter of 2020. The increase was mainly due to higher profit in the fourth quarter of 2021.

Free cash flow (cash flow generated from operating activities, net of cash used for capital investments and beneficial interest collected in exchange for securitized accounts receivables) was $716 million in the fourth quarter of 2021, compared to $471 million in the fourth quarter of 2020. The increase resulted mainly from higher cash flow generated from operating activities.


Segment Results for the Fourth Quarter of 2021

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, 2021 and 2020:

 


Three months ended December 31,

 


2021



2020

 


(U.S. $ in millions / % of Segment Revenues)

Revenues


$

2,003


100%


$

2,300


100%

Gross profit


 

1,145


57.2%


 

1,281


55.7%

R&D expenses


 

151


7.5%


 

167


7.2%

S&M expenses


 

255


12.7%


 

258


11.2%

G&A expenses


 

88


4.4%


 

119


5.2%

Other income


 

(17)


(0.8%)


 

(1)


§

Segment profit*


$

668


33.4%


$

738


32.1%

 


 

 


 


 

 


 

* Segment profit does not include amortization and certain other items.

§ Represents an amount less than 0.5%.











 

Revenues from our North America segment in the fourth quarter of 2021 were $2,003 million, a decrease of $298 million, or 13%, compared to the fourth quarter of 2020, mainly due to lower revenues from generic products and COPAXONE, partially offset by higher revenues from AUSTEDO.

Our North America segment has experienced some reductions in volume due to less physician and hospital activity during the COVID-19 pandemic, but has also experienced increase in demand for certain products related to the treatment of COVID-19 and its symptoms.

Revenues in the United States, our largest market, were $1,877 million in the fourth quarter of 2021, a decrease of $294 million, or 14%, compared to the fourth quarter of 2020.

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, 2021 and 2020:

 

 

Three months ended

December 31,

 

Percentage

Change

 

 

2021

 

2020-2021

 

2020-2021

 

 

(U.S. $ in millions)

 

 

 

 

 

 

 

 

 

 

 

Generic products

 

$

905

 

$

1,206

 

(25%)

AJOVY

 

 

53

 

 

36

 

49%

AUSTEDO

 

 

282

 

 

185

 

52%

BENDEKA®/TREANDA

 

 

93

 

 

102

 

(9%)

COPAXONE

 

 

129

 

 

213

 

(39%)

ProAir®*

 

 

40

 

 

67

 

(40%)

Anda

 

 

355

 

 

321

 

11%

Other

 

 

146

 

 

171

 

(15%)

Total

 

$

2,003

 

$

2,300

 

(13%)

_________

 

 

 

 

 

 

 

 

* Does not include revenues from the ProAir authorized generic, which are included under generic products.

 

 

 

 

 

 

 

 

 


Generic products revenues in our North America segment in the fourth quarter of 2021 decreased by 25% to $905 million, compared to the fourth quarter of 2020, mainly due to increased competition and lower volumes as well as lower revenues from generic launches in the fourth quarter of 2021.

In the fourth quarter of 2021, our total prescriptions were approximately 76 million representing 8.2% of total U.S. generic prescriptions according to IQVIA data.

AJOVY revenues in our North America segment in the fourth quarter of 2021 were $53 million compared to $36 million in the fourth quarter of 2020. This increase was mainly due to growth in volume and favorable net pricing.

AUSTEDO revenues in our North America segment in the fourth quarter of 2021 were $282 million, compared to $185 million in the fourth quarter of 2020. This increase was mainly due to growth in volume, an increase in average daily dose of new patients as well as favorable net pricing.

BENDEKA and TREANDA combined revenues in our North America segment in the fourth quarter of 2021 decreased by 9% to $93 million, compared to the fourth quarter of 2020, mainly due to availability of alternative therapies and continued competition from Belrapzo® (a ready-to-dilute bendamustine hydrochloride product from Eagle Pharmaceuticals, Inc.).

COPAXONE revenues in our North America segment in the fourth quarter of 2021 decreased by 39% to $129 million, compared to the fourth quarter of 2020, mainly due to generic competition in the United States and availability of alternative therapies.

ProAir (HFA and RespiClick) revenues in our North America segment in the fourth quarter of 2021 decreased by 40% to $40 million, compared to the fourth quarter of 2020. In January 2019, we launched our own ProAir authorized generic in the United States, following the launch of a generic version of Ventolin® HFA, another albuterol inhaler. Revenues from our ProAir authorized generic are included in “generic products” above.


Anda revenues in our North America segment in the fourth quarter of 2021 increased by 11% to $355 million, compared to the fourth quarter of 2020.

North America Gross Profit

Gross profit from our North America segment in the fourth quarter of 2021 was $1,145 million, a decrease of 11% compared to the fourth quarter of 2020. This decrease was mainly due to lower revenues from COPAXONE and generic products, partially offset by higher revenues from AUSTEDO and AJOVY.

Gross profit margin for our North America segment in the fourth quarter of 2021 increased to 57.2%, compared to 55.7% in the fourth quarter of 2020. This increase was mainly due to higher revenues from AUSTEDO.

North America Profit

Profit from our North America segment in the fourth quarter of 2021 was $668 million, a decrease of 9% compared to $738 million in the fourth quarter of 2020. Profit decreased mainly due to lower revenues, partially offset by lower operating expenses, as well as higher other income.


Europe Segment

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

The following table presents revenues, expenses and profit for our Europe segment for the three months ended December 31, 2021 and 2020:

 


Three months ended December 31,

 


2021



2020

 


(U.S. $ in millions / % of Segment Revenues)

Revenues


$

1,268


100%


$

1,237


100%

Gross profit


 

760


59.9%


 

657


53.1%

R&D expenses


 

60


4.8%


 

67


5.4%

S&M expenses


 

218


17.2%


 

239


19.4%

G&A expenses


 

64


5.0%


 

77


6.2%

Other income


 

(2)


§


 

§


§

Segment profit*


$

420


33.1%


$

273


22.1%

___________


 

 


 


 

 


 

* Segment profit does not include amortization and certain other items.

§ Represents an amount less than $1 million or 0.5%, as applicable.











 

Revenues from our Europe segment in the fourth quarter of 2021 were $1,268 million, an increase of $31 million, or 2%, compared to the fourth quarter of 2020. In local currency terms, revenues increased by 4%, mainly due to higher demand for generic, OTC and respiratory products due to the impact the COVID-19 pandemic had on purchasing patterns as well as by increasing revenues from AJOVY.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended December 31, 2021 and 2020:

 

 

Three months ended

December 31,

 

Percentage

Change

 

 

2021

 

2020

 

2020-2021

 

 

(U.S. $ in millions)

 

 

Generic products

 

$

932

 

$

920

 

1%

AJOVY

 

 

29

 

 

13

 

121%

COPAXONE

 

 

95

 

 

106

 

(10%)

Respiratory products

 

 

93

 

 

90

 

3%

Other

 

 

119

 

 

107

 

10%

Total

 

$

1,268

 

$

1,237

 

2%

 

 

 

 

 

 

 

 

 


Generic products revenues in our Europe segment in the fourth quarter of 2021, including OTC products, increased by 1% to $932 million, compared to the fourth quarter of 2020. In local currency terms, revenues increased by 4%, mainly due to higher demand resulting from the impact the COVID-19 pandemic had on purchasing patterns.

AJOVY revenues in our Europe segment in the fourth quarter of 2021, were $29 million, compared to $13 million in the fourth quarter of 2020, mainly due to launches and reimbursements in additional European countries and growth in existing countries.

COPAXONE revenues in our Europe segment in the fourth quarter of 2021 decreased by 10% to $95 million, compared to the fourth quarter of 2020. In local currency terms, revenues decreased by 7% due to price reductions and a decline in volume resulting from competing glatiramer acetate products.

Respiratory products revenues in our Europe segment in the fourth quarter of 2021 increased by 3% to $93 million, compared to the fourth quarter of 2020. In local currency terms, revenues increased by 5% mainly due to higher demand resulting from the impact the COVID-19 pandemic had on purchasing patterns.

Europe Gross Profit

Gross profit from our Europe segment in the fourth quarter of 2021 was $760 million, an increase of 16% compared to $657 million in the fourth quarter of 2020. This increase was mainly due to higher revenues, as discussed above.

Gross profit margin for our Europe segment in the fourth quarter of 2021 increased to 59.9%, compared to 53.1% in the fourth quarter of 2020. This increase was mainly due to our network consolidation activities.

Europe Profit

Profit from our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the fourth quarter of 2021 was $420 million, an increase of 54% compared to $273 million in the fourth quarter of 2020. This increase was mainly due to higher gross profit as discussed above and lower operating expenses.

International Markets Segment

Our International Markets segment includes all countries other than those in our North America and Europe segments. The key markets in this segment are Japan, Russia and Israel.

On February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.


The following table presents revenues, expenses and profit for our International Markets segment for the three months ended December 31, 2021 and 2020:

 


Three months ended December 31,

 


2021


 

2020

 


(U.S. $ in millions / % of Segment Revenues)

Revenues


$

527


100%


$

572


100%

Gross profit


 

292


55.3%


 

268


46.9%

R&D expenses


 

17


3.2%


 

19


3.3%

S&M expenses


 

114


21.6%


 

115


20.1%

G&A expenses


 

30


5.7%


 

40


6.9%

Other income


 

§


§


 

(1)


§

Segment profit*


$

131


24.8%


$

96


16.8%

__________


 

 


 


 

 


 

* Segment profit does not include amortization and certain other items.

§ Represents an amount less than $1 million or 0.5%, as applicable.











 

Revenues from our International Markets segment in the fourth quarter of 2021 were $527 million, a decrease of $45 million, or 8%, compared to the fourth quarter of 2020. In local currency terms, revenues decreased by 7% compared to the fourth quarter of 2020, mainly due to lower sales in Japan resulting from the divestment mentioned above, partially offset by higher revenues in most markets.

Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the three months ended December 31, 2021 and 2020:

 

 

 

 

 

 

 

Three months ended

December 31,

 

Percentage

Change

 

 

2021

 

2020

 

2020-2021

 

 

(U.S. $ in millions)

 

 

Generic products

 

$

438

 

$

488

 

(10%)

AJOVY

 

 

4

 

 

1

 

321%

COPAXONE

 

 

8

 

 

15

 

(45%)

Other

 

 

77

 

 

67

 

13%

Total

 

$

527

 

$

572

 

(8%)









 

Generic products revenues in our International Markets segment, which include OTC products, were $438 million in the fourth quarter of 2021, a decrease of 10% compared to the fourth quarter of 2020. In local currency terms, revenues decreased by 7%, mainly due to lower sales in Japan resulting from the divestment mentioned above, partially offset by higher revenues in most markets.


AJOVY was launched in certain markets in our International Markets segment, including in Japan during the third quarter of 2021. We are moving forward with plans to launch AJOVY in other markets. AJOVY revenues in our International Markets segment in the fourth quarter of 2021 were $4 million, compared to $1 million in the fourth quarter of 2020.

COPAXONE revenues in our International Markets segment in the fourth quarter of 2021 decreased by 45% to $8 million, compared to the fourth quarter of 2020. In local currency terms, revenues decreased by 39%.

International Markets Gross Profit

Gross profit from our International Markets segment in the fourth quarter of 2021 was $292 million, an increase of 9% compared to $268 million in the fourth quarter of 2020. Gross profit margin for our International Markets segment in the fourth quarter of 2021 increased to 55.3%, compared to 46.9% in the fourth quarter of 2020. This increase was mainly due to higher profitability resulting from the divestment in Japan mentioned above, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.

International Markets Profit

Profit from our International Markets segment in the fourth quarter of 2021 was $131 million, compared to $96 million in the fourth quarter of 2020. This increase was mainly due to higher gross profit as well as lower G&A expenses.

Other Activities

We have other sources of revenues, primarily the sale of active pharmaceutical ingredients ("APIs") to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments.

Our revenues from other activities in the fourth quarter of 2021 were $302 million, a decrease of 12% compared to the fourth quarter of 2020. In local currency terms revenues decreased by 11%, mainly due to a decrease in volumes from API and Medis resulting from the COVID-19 pandemic, as well as lower revenues from contract manufacturing services.

API sales to third parties in the fourth quarter of 2021 were $206 million, a decrease of 2% in both U.S. dollars and local currency terms, compared to the fourth quarter of 2020.


Outlook for 2022 Non-GAAP Results

$ billions, except EPS


2022 Outlook


2021 Actual

Revenues


15.6 - 16.2


15.9

COPAXONE ($m)


~850


1,005

AUSTEDO ($m)


~1,000


808

AJOVY ($m)


~400


313

Operating Income


4.2-4.5


4.4

EBITDA


4.7-5.0


4.9

EPS ($)


2.40-2.60


2.58

Share Count


1,114 million shares


1,107 million shares

Free Cash Flow


1.9 - 2.2


2.2

CAPEX


0.6


0.6

Non-GAAP Tax Rate


18% - 19%


16.4%

Annual Report on Form 10-K

Teva's Annual Report on Form 10-K for the year ended December 31, 2021, which will be filed with the SEC, will include a complete analysis of the financial results for 2021 and will be available on Teva’s website: http://ir.tevapharm.com, as well as on the SEC’s website: http://www.sec.gov.

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Wednesday, February 9, 2021 at 8:00 a.m. ET to discuss its fourth quarter and annual 2021 results and overall business environment. A question & answer session will follow.


In order to participate, please dial the following numbers:

United States 1-877-870-9135

International +44 (0) 2071 928338
Israel 1-809-213-985

Passcode: 6372826.

A live webcast of the call will be available on Teva's website at: http://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 or by calling the following numbers: United States 1-866-331-1332; International +44 (0) 3333 009785; passcode: 6372826.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Some amounts in this press release may not add up due to rounding. All percentages have been calculated using unrounded amounts.

Non-GAAP Financial Measures

This press release contains certain financial information that differs from what is reported under accounting principles generally accepted in the United States ("GAAP"). These non-GAAP financial measures, including, but not limited to, non-GAAP EPS, non-GAAP operating income, non-GAAP gross profit, non-GAAP gross profit margin, EBITDA, Adjusted EBITDA, non-GAAP R&D expenses, non-GAAP S&M expenses, non-GAAP G&A expenses, non-GAAP financial expenses, non-GAAP income taxes, non-GAAP income (loss) before income taxes, non-GAAP tax rate, non-GAAP net income (loss), non-GAAP net income (loss) attributable to Teva and non-GAAP diluted EPS are presented in order to facilitates investors' understanding of our business. We utilize certain non-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the non-GAAP measures: our management and board of directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; our annual budgets are prepared on a non-GAAP basis; and senior management’s annual compensation is derived, in part, using these non-GAAP measures. 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 replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. We are not providing forward looking guidance for GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP measure because we are unable to predict with reasonable certainty the ultimate outcome of certain significant items without unreasonable effort.


Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that 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 successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO, AJOVY and COPAXONE; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
  • our business and operations in general, including: uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic;
  • the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
  • compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; environmental risks; and the impact of ESG issues;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); and 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;
    and other factors discussed in this press release and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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 cautioned not to put undue reliance on these forward-looking statements.

 









 

Consolidated Statements of Income (Loss)

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









 


Three months ended


Year ended



December 31,


December 31,



2021


2020


2021


2020



(Unaudited)


(Unaudited)


(Audited)


(Audited)

Net revenues

4,100

 


4,454

 


15,878

 


16,659

 

Cost of sales

2,049

 


2,405

 


8,284

 


8,933

 

Gross profit

2,050

 


2,048

 


7,594

 


7,726

 

Research and development expenses, net

244

 


293

 


967

 


997

 

Selling and marketing expenses

632

 


683

 


2,429

 


2,498

 

General and administrative expenses

276

 


327

 


1,099

 


1,173

 

Intangible assets impairment

129

 


224

 


424

 


1,502

 

Goodwill impairment

-

 


-

 


-

 


4,628

 

Other asset impairments, restructuring and other items

113

 


75

 


341

 


479

 

Legal settlements and loss contingencies

604

 


50

 


717

 


60

 

Other income

(26

)


(10

)


(98

)


(40

)

Operating income (loss)

78

 


406

 


1,716

 


(3,572

)

Financial expenses – net

253

 


268

 


1,058

 


834

 

Income (loss) before income taxes

(175

)


138

 


658

 


(4,406

)

Income taxes (benefit)

(24

)


(22

)


211

 


(168

)

Share in (profits) losses of associated companies, net

-

 


(3

)


(9

)


(138

)

Net income (loss)

(151

)


162

 


456

 


(4,099

)

Net income (loss) attributable to non-controlling interests

7

 


12

 


39

 


(109

)

Net income (loss) attributable to Teva

(159

)


150

 


417

 


(3,990

)









 








 








 








 
Earnings (loss) per share attributable to Teva: Basic ($)

(0.14

)


0.14

 


0.38

 


(3.64

)


Diluted ($)

(0.14

)


0.14

 


0.38

 


(3.64

)

Weighted average number of shares (in millions): Basic

1,103

 


1,096

 


1,102

 


1,095

 


Diluted

1,103

 


1,100

 


1,107

 


1,095

 









 








 
Non-GAAP net income attributable to Teva:*

854

 


753

 


2,855

 


2,830

 

Non-GAAP net income attributable to Teva for diluted earnings per share:

854

 


753

 


2,855

 


2,830

 









 
Non-GAAP earnings per share attributable to Teva:* Basic ($)

0.77

 


0.69

 


2.59

 


2.58

 


Diluted ($)

0.77

 


0.68

 


2.58

 


2.57

 









 
Non-GAAP average number of shares (in millions): Basic

1,103

 


1,096

 


1,102

 


1,095

 


Diluted

1,108

 


1,100

 


1,107

 


1,099

 









 








 
* See reconciliation attached.









Condensed Consolidated Balance Sheets


(U.S. dollars in millions)


(Audited)






 



December 31,


December 31,




2021


2020


ASSETS




Current assets:




Cash and cash equivalents

2,165


2,177


Accounts receivables, net of allowance for credit losses of $90 million and $126 million as of December 31, 2021 and December 31, 2020

4,529


4,581


Inventories

3,818


4,403


Prepaid expenses

1,075


945


Other current assets

965


710


Assets held for sale

19


189


Total current assets

12,573


13,005


Deferred income taxes

596


695


Other non-current assets

515


538


Property, plant and equipment, net

5,982


6,296


Operating lease right-of-use assets

495


559


Identifiable intangible assets, net

7,466


8,923


Goodwill

20,040


20,624


Total assets

47,666


50,640






 

LIABILITIES & EQUITY




Current liabilities:




Short-term debt

1,426


3,188


Sales reserves and allowances

4,241


4,824


Trade payables

1,686


1,756


Employee-related obligations

563


685


Accrued expenses

2,208


1,780


Other current liabilities

903


933


Total current liabilities

11,027


13,164






 

Long-term liabilities:




Deferred income taxes

784


964


Other taxes and long-term liabilities

2,578


2,240


Senior notes and loans

21,617


22,731


Operating lease liabilities

416


479


Total long-term liabilities

25,395


26,414


Equity:




Teva shareholders’ equity

10,278


10,026


Non-controlling interests

966


1,035


Total equity

11,244


11,061


Total liabilities and equity

47,666


50,640


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in millions)
(Unaudited)











 

Year ended


Three months ended


December 31,


December 31,


2021


2020


2021


2020

Operating activities:

(Audited)



(Audited)



(Unaudited)



(Unaudited)

Net income (loss) $

456

 


$

(4,099

)


$

(152

)


$

162

 

Adjustments to reconcile net income (loss) to net cash provided by operations:










Impairment of goodwill, long-lived assets and assets held for sale

584

 



6,546

 



183

 



232

 

Depreciation and amortization

1,330

 



1,557

 



320

 



395

 

Net change in operating assets and liabilities

(1,701

)



(2,188

)



180

 



(561

)

Deferred income taxes — net and uncertain tax positions

(120

)



(696

)



(133

)



(40

)

Stock-based compensation

119

 



129

 



33

 



38

 

Other items

16

 



100

 



20

 



46

 

Research and development in process

10

 



80

 



10

 



40

 

Net loss (gain) from investments and from sale of business and long lived assets

104

 



(213

)



(5

)



19

 

Net cash provided by operating activities

798

 



1,216

 



456

 



331

 












 
Investing activities:










Beneficial interest collected in exchange for securitized trade receivables

1,648

 



1,405

 



370

 



303

 

Proceeds from sale of business and long lived assets

311

 



67

 



42

 



13

 

Purchases of property, plant and equipment

(562

)



(578

)



(153

)



(176

)

Purchases of investments and other assets

(47

)



(55

)



(11

)



(9

)

Proceeds from sale of investments

172

 



12

 



-

 



-

 

Other investing activities

1

 



12

 



(2

)



10

 

Net cash provided by investing activities

1,523

 



863

 



246

 



141

 












 
Financing activities:










Repayment of senior notes and loans and other long term liabilities

(6,649

)



(1,871

)



(5,174

)



-

 

Proceeds from senior notes, net of issuance costs

4,974

 



-

 



4,974

 



-

 

Proceeds from short term debt

700

 



550

 



200

 



319

 

Repayment of short term debt

(700

)



(559

)



(500

)



(443

)

Redemption of convertible debentures

(491

)



-

 



-

 



-

 

Other financing activities

(6

)



(5

)



(1

)



(1

)

Net cash used in financing activities

(2,172

)



(1,885

)



(501

)



(125

)

Translation adjustment on cash and cash equivalents

(128

)



8

 



(48

)



3

 

Net change in cash and cash equivalents and restricted cash $

21

 


$

202

 


$

153

 


$

350

 

Balance of cash and cash equivalents and restricted cash at beginning of year

2,177

 



1,975

 



2,045

 



1,827

 

Balance of cash and cash equivalents and restricted cash at end of year

2,198

 



2,177

 



2,198

 



2,177

 












 











 
Reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets:










Cash and cash equivalents

2,165

 



2,177

 



2,165

 



2,177

 

Restricted cash included in other current assets

33

 



-

 



33

 



-

 

Total cash, cash equivalents and restricted cash shown in the statements of cash flows

2,198

 



2,177

 



2,198

 



2,177

 












 











 











 


Three Months Ended December 31, 2021


U.S. $ and shares in millions (except per share amounts)


GAAP


Excluded for non GAAP measurement


Non GAAP




Amortization of

purchased

intangible assets

Legal

settlements and

loss

contingencies

Impairment of

long-lived

assets

Other R&D

expenses

Restructuring

costs

Costs related to

regulatory actions

taken in facilities

Equity

compensation

Contingent

consideration

Gain on sale

of business

Other

non

GAAP

items

Other items



Net revenue

4,100

 














4,100

 

Cost of sales

2,049

 


165





5

6



75



1,798

 

Gross profit

2,050

 


165

-

-

-

-

5

6

-

-

 

75

-

 


2,301

 

Gross profit margin

50.0

%














56.1

%

R&D

244

 





10



5



-



229

 

S&M

632

 


24






8



-



600

 

G&A

276

 








12



20



244

 

Other income

(26

)










(7

)




(19

)

Legal settlements and loss contingencies

604

 



604











-

 

Other asset impairments, restructuring and other items

113

 




54


37



14


8



-

 

Intangible assets impairment

129

 




129










-

 

Operating income (loss)

78

 


188

604

183

10

37

5

32

14

(7

)

103

-

 


1,248

 

Financial expenses

253

 












25

 


229

 

Income (loss) before income taxes

(175

)


188

604

183

10

37

5

32

14

(7

)

103

25

 


1,019

 

Income taxes

(24

)












(178

)


153

 

Net income (loss)

(151

)


188

604

183

10

37

5

32

14

(7

)

103

(153

)


866

 

Net income (loss) attributable to non-controlling interests

7

 












(5

)


12

 

Net income (loss) attributable to Teva

(159

)


188

604

183

10

37

5

32

14

(7

)

103

(158

)


854

 
















 















 
EPS - Basic

(0.14

)












0.92

 


0.77

 

EPS - Diluted

(0.14

)












0.91

 


0.77

 
















 















 



The non-GAAP diluted weighted average number of shares was 1,108 million for the three months ended December 31, 2021.




Non-GAAP income taxes for the three months ended December 31, 2021 were 15% on pre-tax non-GAAP income.




* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
















 
Adjusted EBITDA reconciliation














Operating income (loss)

78

 















Add:














Depreciation

132

 















Amortization

188

 















EBITDA

397

 















Legal settlements and loss contingencies

604

 















Impairment of long lived assets

183

 















Other R&D expenses

10

 















Restructuring costs

37

 















Costs related to regulatory actions taken in facilities

5

 















Equity compensation

32

 















Contingent consideration

14

 















Gain on sale of business

(7

)















Other non-GAAP items (excluding accelerated depreciation of $4.7 million)*

98

 















Adjusted EBITDA

1,373

 






























 
* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.


Three Months Ended December 31, 2020


U.S. $ and shares in millions (except per share amounts)


GAAP


Excluded for non GAAP measurement


Non GAAP




Amortization of

purchased

intangible assets

Legal settlements

and loss

contingencies

Impairment of

long-lived assets

Other R&D

expenses

Restructuring costs

Costs related to

regulatory actions

taken in facilities

Equity compensation

Contingent

consideration

Gain on sale of

business

Other non

GAAP items

Other items



Net revenue

4,454

 














4,454

 

Cost of sales

2,405

 


231

 





7

8



34



2,126

 

Gross profit

2,048

 


231

 

-

-

-

-

7

8

-

-

 

34

-

 


2,327

 

Gross profit margin

46.0

%














52.3

%

R&D expenses

293

 





34



6



-



254

 

S&M expenses

683

 


31

 






11



14



627

 

G&A expenses

327

 








15



-



312

 

Other (income) expense

(10

)










(5

)




(5

)

Legal settlements and loss contingencies

50

 



50











-

 

Other asset impairments, restructuring and other items

75

 




8


38



15


14



-

 

Intangible assets impairment

224

 




224










-

 

Operating income (loss)

406

 


262

 

50

233

34

38

7

40

15

(5

)

62

-

 


1,140

 

Financial expenses

268

 












33

 


235

 

Income (loss) before income taxes

138

 


262

 

50

233

34

38

7

40

15

(5

)

62

33

 


905

 

Income taxes

(22

)












(162

)


141

 

Share in profits (losses) of associated companies – net

(3

)












-

 


(3

)

Net income (loss)

162

 


262

 

50

233

34

38

7

40

15

(5

)

62

(129

)


767

 

Net income (loss) attributable to non-controlling interests

12

 












(2

)


14

 

Net income (loss) attributable to Teva

150

 


262

 

50

233

34

38

7

40

15

(5

)

62

(131

)


753

 
















 
EPS - Basic

0.14

 












0.55

 


0.69

 

EPS - Diluted

0.14

 












0.55

 


0.68

 
















 



The non-GAAP diluted weighted average number of shares was 1,100 million for the three months ended December 31, 2020.




Non-GAAP income taxes for the three months ended December 31, 2021 were 16% on pre-tax non-GAAP income.




* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
















 
Adjusted EBITDA reconciliation














Operating income (loss)

406

 













Add:














Depreciation

140

 













Amortization

262

 













EBITDA

808

 













Legal settlements and loss contingencies

50

 













Impairment of long lived assets

233

 













Other R&D expenses

34

 













Restructuring costs

38

 













Costs related to regulatory actions taken in facilities

7

 













Equity compensation

40

 













Contingent consideration

15

 













Gain on sale of business

(5

)













Other non-GAAP items (excluding accelerated depreciation of $3 million)*

58

 
















1,277

 




























 
* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.















 


Year Ended December 31, 2021


(U.S. $ and shares in millions, except per share amounts)


GAAP

Excluded for non-GAAP measurement

Non-GAAP



Amortization

of purchased

intangible

assets

Legal

settlements and

loss

contingencies

Impairment

of long-lived

assets

Other R&D

expenses

Restructuring

costs

Costs related

to regulatory

actions taken

in facilities

Equity

compensation

Contingent

consideration

Gain on

sale of

business

Other non-

GAAP items

Other items


Net revenue

15,878

 












15,878

 

Cost of sales

8,284

 

702





23

23



270


7,266

 

Gross profit

7,594

 

702

-

-

-

-

23

23

-

-

 

270

-

 

8,612

 

Gross profit margin

48.0

%












54.0

%

R&D expenses

967

 




15



19



-


933

 

S&M expenses

2,429

 

99






33



-


2,297

 

G&A expenses

1,099

 







43



27


1,029

 

Other (income) expense

(98

)









(51

)



(48

)

Legal settlements and loss contingencies

717

 


717










-

 

Other asset impairments, restructuring and other items

341

 



160


133



7


40


-

 

Intangible assets impairment

424

 



424









-

 

Operating income (loss)

1,716

 

802

717

584

15

133

23

118

7

(51

)

337

-

 

4,401

 

Financial expenses

1,058

 











128

 

930

 

Income (loss) before income taxes

658

 

802

717

584

15

133

23

118

7

(51

)

337

128

 

3,471

 

Income taxes

211

 











(360

)

570

 

Share in profits (losses) of associated companies – net

(9

)











(1

)

(8

)

Net income (loss)

456

 

802

717

584

15

133

23

118

7

(51

)

337

(232

)

2,909

 

Net income (loss) attributable to non-controlling interests

39

 











(15

)

54

 

Net income (loss) attributable to Teva

417

 

802

717

584

15

133

23

118

7

(51

)

337

(247

)

2,855

 














 
EPS - Basic

0.38

 











2.21

 

2.59

 

EPS - Diluted

0.38

 











2.20

 

2.58

 














 


The non-GAAP diluted weighted average number of shares was 1,107 million for the year ended December 31, 2021.



Non-GAAP income taxes for the year ended December 31, 2021 were 16% on pre-tax non-GAAP income.



* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.














 













 













 
Adjusted EBITDA reconciliation












Operating income (loss)

1,716

 













Add:












Depreciation

528

 













Amortization

802

 













EBITDA

3,046

 













Legal settlements and loss contingencies

717

 













Impairment of long lived assets

584

 













Other R&D costs

15

 













Restructuring costs

133

 













Costs related to regulatory actions taken in facilities

23

 













Equity compensation

118

 













Contingent consideration

7

 













Gain on sale of business

(51

)













Other non-GAAP items (excluding accelerated depreciation of $18 million)*

318

 













Adjusted EBITDA

4,911

 


























 

* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.














 


Year ended December 31, 2020


(U.S. $ and shares in millions, except per share amounts)


GAAP

Excluded for non-GAAP measurement

Non-GAAP



Amortization of

purchased

intangible assets

Legal

settlements and

loss

contingencies

Goodwill

impairment

Impairment of

long-lived assets

Other

R&D

expenses

Restructuring

costs

Costs related to

regulatory actions

taken in facilities

Equity

compensation

Contingent

consideration

Gain on sale

of business

Other non-

GAAP items

Other

items


Net revenue

16,659

 













16,659

 

Cost of sales

8,933

 

894






23

27



63


7,925

 

Gross profit

7,726

 

894






23

27



63


8,734

 

Gross profit margin

46.4

%













52.4

%

R&D expenses

997

 





37



20



-


941

 

S&M expenses

2,498

 

126







36



14


2,322

 

G&A expenses

1,173

 








46



12


1,115

 

Other (income) expense

(40

)










(8

)



(31

)

Legal settlements and loss contingencies

60

 


60











-

 

Other asset impairments, restructuring and other items

479

 




416


120



(81

)


24


-

 

Intangible assets impairment

1,502

 




1,502









-

 

Goodwill impairment

4,628

 



4,628










-

 

Operating income (loss)

(3,572

)

1,020

60

4,628

1,918

37

120

23

129

(81

)

(8

)

114

-

 

4,388

 

Financial expenses, net

834

 












(85

)

918

 

Income (loss) before income taxes

(4,406

)

1,020

60

4,628

1,918

37

120

23

129

(81

)

(8

)

114

(85

)

3,470

 

Income taxes

(168

)












(745

)

577

 

Share in profits (losses) of associated companies – net

(138

)












(134

)

(4

)

Net income (loss)

(4,099

)

1,020

60

4,628

1,918

37

120

23

129

(81

)

(8

)

114

(964

)

2,897

 

Net income (loss) attributable to non-controlling interests

(109

)












(177

)

68

 

Net income (loss) attributable to Teva

(3,990

)

1,020

60

4,628

1,918

37

120

23

129

(81

)

(8

)

114

(1,140

)

2,830

 

EPS - Basic

(3.64

)












6.23

 

2.58

 

EPS - Diluted

(3.64

)












6.22

 

2.57

 















 














 


The non-GAAP diluted weighted average number of shares was 1,099 million for the year ended December 31, 2020.



Non-GAAP income taxes for the year ended December 31, 2020 were 17% on pre-tax non-GAAP income.



* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.















 














 
Adjusted EBITDA reconciliation













Operating income (loss)

(3,572

)














Add:













Depreciation

545

 














Amortization

1,020

 














EBITDA

(2,007

)














Legal settlements and loss contingencies

60

 














Goodwill impairment

4,628

 














Impairment of long lived assets

1,918

 














Other R&D expenses

37

 














Restructuring costs

120

 














Costs related to regulatory actions taken in facilities

23

 














Equity compensation

129

 














Contingent consideration

(81

)














Gain on sale of business

(8

)














Other non-GAAP items (excluding accelerated depreciation of $21 million)*

93

 














Adjusted EBITDA

4,912

 




























 

* Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.















 



















 


Segment Information


















 


North America


Europe


International Markets



Three months ended

December 31,


Three months ended

December 31,


Three months ended

December 31,



2021


2020


2021


2020


2021


2020



















 


(U.S. $ in millions)


(U.S. $ in millions)


(U.S. $ in millions)



















 
Revenues
$

2,003

 


$

2,300

 


$

1,268

 


$

1,237


$

527


$

572

 

Gross profit

1,145

 



1,281

 



760

 



657



292



268

 

R&D expenses

151

 



167

 



60

 



67



17



19

 

S&M expenses

255

 



258

 



218

 



239



114



115

 

G&A expenses

88

 



119

 



64

 



77



30



40

 

Other (income) expense

(17

)



(1

)



(2

)



§

§

(1

)

Segment profit
$

668

 


$

738

 


$

420

 


$

273


$

131


$

96

 



















 



















 


Segment Information



















 


North America


Europe


International Markets



Year ended December 31,


Year ended December 31,


Year ended December 31,



2021


2020


2021


2020


2021


2020



















 


(U.S. $ in millions)
(U.S. $ in millions)

(U.S. $ in millions)



















 
Revenues
$

7,809

 


$

8,447

 


$

4,886

 


$

4,757

 


$

2,032

 


$

2,154

 

Gross profit

4,226

 



4,489

 



2,823

 



2,666

 



1,118

 



1,096

 

R&D expenses

618

 



622

 



244

 



247

 



68

 



70

 

S&M expenses

988

 



1,013

 



846

 



830

 



417

 



427

 

G&A expenses

427

 



443

 



244

 



261

 



109

 



136

 

Other (income) expense

(31

)



(10

)



(5

)



(3

)



(5

)



(11

)

Segment profit
$

2,224

 


$

2,421

 


$

1,494

 


$

1,331

 


$

529

 


$

474

 



















 

Reconciliation of our segment profit

to consolidated income before income taxes



Three months ended



December 31,



2021


2020







 


(U.S.$ in millions)







 
North America profit
$

668

 


$

738

Europe profit

420

 



273

International Markets profit

131

 



96

Total segment profit

1,219

 



1,107

Profit of other activities

29

 



33

Total segment profit

1,248

 



1,140

Amounts not allocated to segments:





Amortization

188

 



262

Other asset impairments, restructuring and other items

113

 



75

Intangible asset impairments

129

 



224

Legal settlements and loss contingencies

604

 



50

Other unallocated amounts

136

 



123

Consolidated operating income (loss)

78

 



406

Financial expenses - net

253

 



268

Consolidated income (loss) before income taxes
$

(175

)


$

138


Reconciliation of our segment profit

to consolidated income before income taxes



Year ended



December 31,



2021


2020







 


(U.S.$ in millions)







 
North America profit
$

2,224


$

2,421

 

Europe profit

1,494



1,331

 

International Markets profit

529



474

 

Total segment profit

4,246



4,225

 

Profit (loss) of other activities

154



163

 

Total segment profit

4,401



4,388

 

Amounts not allocated to segments:





Amortization

802



1,020

 

Other asset impairments, restructuring and other items

341



479

 

Goodwill impairment

-



4,628

 

Intangible asset impairments

424



1,502

 

Legal settlements and loss contingencies

717



60

 

Other unallocated amounts

402



271

 

Consolidated operating income (loss)

1,716



(3,572

)

Financial expenses - net

1,058



834

 

Consolidated income (loss) before income taxes
$

658


$

(4,406

)










 

Revenues by Activity and Geographical Area

(Unaudited)









 


Three months ended





December 31,


Percentage

Change



2021


2020


2020-2021



(U.S.$ in millions)



North America segment







Generics products
$

905


$

1,206


(25%)

AJOVY

53



36


49%

AUSTEDO

282



185


52%

BENDEKA/TREANDA

93



102


(9%)

COPAXONE

129



213


(39%)

ProAir*

40



67


(40%)

Anda

355



321


11%

Other

146



171


(15%)

Total

2,003



2,300


(13%)









 
* Does not include revenues from the ProAir authorized generic, which are included under generic products.


Three months ended





December 31,


Percentage

Change



2021


2020


2020-2021



(U.S.$ in millions)



Europe segment







Generics products
$

932


$

920


1%

AJOVY

29



13


121%

COPAXONE

95



106


(10%)

Respiratory products

93



90


3%

Other

119



107


10%

Total

1,268



1,237


2%









 








 








 


Three months ended





December 31,


Percentage

Change



2021


2020


2020-2021



(U.S.$ in millions)



International Markets segment







Generics products
$

438


$

488


(10%)

AJOVY

4



1


321%

COPAXONE

8



15


(45%)

Other

77



67


13%

Total

527



572


(8%)









 









 

Revenues by Activity and Geographical Area

(Unaudited)









 


Year ended





December 31,


Percentage

Change



2021


2020


2020-2021



(U.S.$ in millions)



North America segment







Generics products
$

3,769



4,010


(6%)

AJOVY

176



134


31%

AUSTEDO

802



637


26%

BENDEKA/TREANDA

385



415


(7%)

COPAXONE

577



884


(35%)

ProAir*

180



241


(25%)

Anda

1,323



1,462


(9%)

Other

597



664


(10%)

Total

7,809



8,447


(8%)









 
* Does not include revenues from the ProAir authorized generic, which are included under generic products.








 


Year ended





December 31,


Percentage

Change



2021


2020


2020-2021



(U.S.$ in millions)



Europe segment







Generics products
$

3,569


$

3,513


2%

AJOVY

87



31


184%

COPAXONE

391



400


(2%)

Respiratory products

356



353


1%

Other

483



459


5%

Total

4,886



4,757


3%









 








 


Year ended





December 31,


Percentage

Change



2021


2020


2020-2021



(U.S.$ in millions)



International Markets segment







Generics products
$

1,649


$

1,792


(8%)

AJOVY

50



18


179%

COPAXONE

37



53


(29%)

Other

295



291


1%

Total

2,032



2,154


(6%)


Free cash flow reconciliation

(Unaudited)






 

Three months ended December 31,


2021


2020






 

(U.S. $ in millions)






 
Net cash provided by operating activities

456

 



331

 

Beneficial interest collected in exchange for securitized accounts receivables

370

 



303

 

Purchase of property, plant and equipment

(153

)



(176

)

Proceeds from sale of business and long lived assets

43

 



13

 

Free cash flow $

716

 


$

471

 


Free cash flow reconciliation

(Unaudited)






 

Year ended December 31,


2021


2020






 

(U.S. $ in millions)






 
Net cash provided by operating activities

798

 



1,216

 

Beneficial interest collected in exchange for securitized accounts receivables

1,648

 



1,405

 

Purchases of property, plant and equipment

(562

)



(578

)

Proceeds from sale of business and long lived assets

311

 



67

 

Free cash flow $

2,196

 


$

2,110

 

 

Contacts

IR Contacts
Ran Meir (267) 468-4475
Yael Ashman +972 (3) 914 8262

PR Contacts
Kelley Dougherty (973) 832-2810
Eden Klein +972 (3) 906 2645

EX-101.SCH 3 teva-20220209.xsd XBRL TAXONOMY EXTENSION SCHEMA 000100 - Document - Document and Entity Information link:presentationLink link:calculationLink link:definitionLink EX-101.LAB 4 teva-20220209_lab.xml XBRL TAXONOMY EXTENSION LABEL LINKBASE Cover [Abstract] Document Type Written Communications Soliciting Material Pre-commencement Tender Offer Pre-commencement Issuer Tender Offer Amendment Flag Document Fiscal Year Focus Document Fiscal Period Focus Document Period End Date Entity Registrant Name Entity Central Index Key Entity File Number Entity Tax Identification Number Entity Incorporation, State or Country Code Entity Emerging Growth Company Entity Address, Address Line One Entity Address, Address Line Two Entity Address, Address Line Three Entity Address, City or Town Entity Address, State or Province Entity Address, Country Entity Address, Postal Zip Code City Area Code Local Phone Number Title of 12(b) Security No Trading Symbol Flag Trading Symbol Security Exchange Name EX-101.PRE 5 teva-20220209_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE XML 6 R1.htm IDEA: XBRL DOCUMENT v3.22.0.1
Document and Entity Information
Feb. 09, 2022
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 09, 2022
Entity Registrant Name TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Entity Incorporation, State or Country Code L3
Entity File Number 001-16174
Entity Tax Identification Number 00-0000000
Entity Address, Address Line One 124 Dvora Hanevi’a Street
Entity Address, City or Town Tel Aviv
Entity Address, Country IL
Entity Address, Postal Zip Code 6944020
City Area Code 972
Local Phone Number 3-914-8213
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Entity Central Index Key 0000818686
Title of 12(b) Security American Depositary Shares, each representing one Ordinary Share
Trading Symbol TEVA
Security Exchange Name NYSE
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