0001193125-22-269052.txt : 20230124 0001193125-22-269052.hdr.sgml : 20230124 20221026080029 ACCESSION NUMBER: 0001193125-22-269052 CONFORMED SUBMISSION TYPE: CORRESP PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20221026 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: CORRESP 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 CORRESP 1 filename1.htm CORRESP

LOGO

October 26, 2022

Securities and Exchange Commission

Division of Corporation Finance, Office of Life Sciences

100 F Street, N.E.

Washington, D.C. 20549

Attn: Li Xiao and Frank Wyman

 

Re:    Teva Pharmaceutical Industries Limited
Form 10-K for the Fiscal Year Ended December 31, 2021
filed February 9, 2022
File No. 001-16174

Ladies and Gentlemen:

On behalf of Teva Pharmaceutical Industries Limited (“Teva” or the “Company”), set forth below is Teva’s response to the comment of the staff (the “Staff”) of the Securities and Exchange Commission contained in your letter dated September 13, 2022 to Eli Kalif, Teva’s Executive Vice President and Chief Financial Officer.

For your ease of reference, we have set forth below the Staff’s comment in italics, followed by Teva’s response thereto.

Form 10-K for the Fiscal Year Ended December 31, 2021

Management’s Discussion and Analysis of Financial Condition and Results of Operations Supplemental Non-GAAP Income Data, page 73

1.    We note that you modified your non-GAAP reconciliation in your 2021 Annual and Quarterly Reports to essentially present a full non-GAAP Statement of Income, which is specifically prohibited by Question 102.10 of the Compliance and Disclosure Interpretations on Non-GAAP Financial Measures. Please confirm that you will revise your future filings to eliminate the full non-GAAP Statement of Income and provide us with a draft of your proposed changes.

Response: The Company acknowledges the Staff’s comment and confirms that the Company will not present a full non-GAAP Statement of Income in its filings for future financial periods. To address the concerns raised by the Staff, the Company will revise its presentation of its non-GAAP financial measures in future filings to substantially reflect the proposed changes to the presentation of the Company’s reconciliation of its non-GAAP financial measures for the years ended December 31, 2021 and 2020 set forth in Exhibit A hereto in connection with future Form 10-K and Form 10-Q filings and as set forth in Exhibit B hereto in connection with future earnings press releases.

* * * * * *

 


Should any member of the Staff have any questions or comments concerning this letter, please do not hesitate to call me.

Very Truly Yours,

 

/s/ Eli Kalif

Eli Kalif

Executive Vice President, Chief Financial Officer

Teva Pharmaceutical Industries Limited

cc:

David Stark, Executive Vice President, Chief Legal Officer, Teva

Amir Weiss, Senior Vice President Finance, Chief Accounting Officer, Teva

Ross M. Leff, Kirkland & Ellis LLP

 

2


Exhibit A

 

3


Non-GAAP Net Income and Non-GAAP EPS Data

We present non-GAAP net income and non-GAAP earnings per share (“EPS”) as management believes that such data provide useful information to investors because they are used by management and our Board of Directors, in conjunction with other performance metrics, to evaluate our operational performance, to prepare and evaluate our work plans and annual budgets and ultimately to evaluate the performance of management, including annual compensation. While other qualitative factors and judgment also affect annual compensation, the principal quantitative element in the determination of such compensation are performance targets tied to the work plan, which are based on these non-GAAP measures.

Non-GAAP financial measures have no standardized meaning and accordingly have limitations in their usefulness to investors. Investors are cautioned that, unlike financial measures prepared in accordance with U.S. GAAP, non-GAAP measures may not be comparable with the calculation of similar measures for other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using non-GAAP financial measures as performance measures are that they provide a view of our results of operations without including all events during a period and may not provide a comparable view of our performance to other companies in the pharmaceutical industry. Investors should consider non-GAAP net income and non-GAAP EPS in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP.

In preparing our non-GAAP net income and non-GAAP EPS data, we exclude items that either have a non-recurring impact on our financial performance or which, in the judgment of our management, are items that, either as a result of their nature or size, could, were they not excluded, potentially cause investors to extrapolate future performance from an improper base that is not reflective of our underlying business performance. Certain of these items are also excluded because of the difficulty in predicting their timing and scope. The items excluded from our non-GAAP net income and non-GAAP EPS include:

 

   

amortization of purchased intangible assets;

 

   

legal settlements and material litigation fees and/or loss contingencies, due to the difficulty in predicting their timing and scope;

 

   

impairments of long-lived assets, including intangibles, property, plant and equipment and goodwill;

 

   

restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to the rationalization of our plants or to certain other strategic activities, such as the realignment of R&D focus or other similar activities;

 

   

acquisition- or divestment- related items, including changes in contingent consideration, integration costs, banker and other professional fees and inventory step-up;

 

   

expenses related to our equity compensation;

 

   

significant one-time financing costs, amortization of issuance costs and terminated derivative instruments, and marketable securities investment valuation gains/losses;

 

   

unusual tax items;

 

   

other awards or settlement amounts, either paid or received;

 

   

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 impacts due to changes in accounting, significant costs for remediation of plants or related consulting costs, or other unusual events; and

 

   

corresponding tax effects of the foregoing items.

 

 

4


The following table presents our non-GAAP net income and non-GAAP EPS for the years ended December 31, 2021 and December 31, 2020, as well as reconciliations of each measure to their nearest GAAP equivalents:

 

     Year Ended December 31,  
     2021      2020  
     (U.S. dollars and
shares in millions,
except per share
amounts)
 

Net Income (loss) attributable to Teva

   $ 417      $ (3,990

Increase (decrease) for excluded items:

     

Amortization of purchased intangible assets

     802        1,020  

Legal settlements and loss contingencies

     717        60  

Goodwill impairment

     —          4,628  

Impairment of long-lived assets

     584        1,918  

Other R&D expenses

     15        37  

Restructuring costs

     133        120  

Costs related to regulatory actions taken in facilities

     23        23  

Equity compensation

     118        129  

Contingent consideration

     7        (81

Gain on sale of business

     (51      (8

Financial expenses

     128        (85

Share in profits (losses) of associated companies – net

     —          (134

Items attributable to non-controlling interests

     (15      (177

Other non-GAAP items*

     337        114  

Corresponding tax effects and unusual tax items

     (360      (745
  

 

 

    

 

 

 

Non-GAAP net income attributable to Teva

   $ 2,855      $ 2,830  
  

 

 

    

 

 

 

Diluted earnings (loss) per share attributable to Teva

   $ 0.38      $ (3.64

EPS difference**

     2.20        6.22  

Diluted Non-GAAP EPS attributable to Teva**

   $ 2.58      $ 2.57  

 

*

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, primarily related to the rationalization of our plants and other unusual events.

**

EPS difference and diluted non-GAAP EPS are calculated by dividing the sum of our non-GAAP adjustments and our non-GAAP net income attributable to Teva, respectively, by our non-GAAP diluted weighted average number of shares. The non-GAAP diluted weighted average number of shares for the years ended December 31, 2021 and 2020 were 1,107 million and 1,099 million, respectively.

 

5


Exhibit B

 

6


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
       

R&D expenses

    244             10           5               229  

S&M expenses

    632       24                 8               600  

G&A expenses

    276                   12           20         244  

Other (income) expense

    (26                     (7         (19

Financial expenses

    253                           25       229  

Income taxes

    (24                         (178     153  

Gross profit

    2,050       165               5       6           75         2,301  

Gross profit margin

    50.0                           56.1

Operating income (loss)

    78       188       604       183       10       37       5       32       14       (7     103         1,248  

Net income (loss) attributable to Teva

    (159     188       604       183       10       37       5       32       14       (7     103       (158     854  

EPS - Diluted

    (0.14     0.17       0.54       0.17       0.01       0.03     §       0.03       0.01       (0.01     0.09       (0.14     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, primarily related to the rationalization of our plants and other unusual events.

§

Represents an amount less than $0.01

 

Adjusted EBITDA reconciliation    

  

Net income (loss)

     (151

Add:

  

Financial expenses

     253  

Income taxes

     (24

Depreciation

     132  

Amortization

     188  
  

 

 

 

EBITDA

     397  
  

 

 

 

Legal settlements and loss contingencies

     604  

Impairment of long lived assets

     183  

Other R&D costs

     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 $18 million)*

     98  
  

 

 

 

Adjusted EBITDA

     1,373  
  

 

 

 

 

*

Includes other items primarily related to the rationalization of our plants and other exceptional events.

 

7


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
       

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

Financial expenses

    268                           33       235  

Income taxes

    (22                         (162     141  

Gross profit

    2,048       231               7       8           34         2,327  

Gross profit margin

    46.0                           52.3

Operating income (loss)

    406       262       50       233       34       38       7       40       15       (5     62       —         1,140  

Net income (loss) attributable to Teva

    150       262       50       233       34       38       7       40       15       (5     62       (131     753  

EPS - Diluted

    0.14       0.24       0.05       0.21       0.03       0.04       0.01       0.04       0.01     §       0.06       (0.12     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, 2020 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, primarily related to the rationalization of our plants and other unusual events.

§

Represents an amount less than $0.01

 

Adjusted EBITDA reconciliation    

  

Net income (loss)

     162  

Add:

  

Financial expenses

     268  

Income taxes

     (22

Share in profits (losses) of associated companies – net

     (3

Depreciation

     140  

Amortization

     262  
  

 

 

 

EBITDA

     808  
  

 

 

 

Legal settlements and loss contingencies

     50  

Impairment of long lived assets

     233  

Other R&D costs

     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 $18 million)*

     58  
  

 

 

 

Adjusted EBITDA

     1,277  
  

 

 

 

 

*

Includes other items primarily related to the rationalization of our plants and other exceptional events.

 

8


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
       

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

Financial expenses

    1,058                           128       930  

Income taxes

    211                           (360     570  

Gross profit

    7,594       702               23       23           270         8,612  

Gross profit margin

    48.0                           54.0

Operating income (loss)

    1,716       802       717       584       15       133       23       118       7       (51     337         4,401  

Net income (loss) attributable to Teva

    417       802       717       584       15       133       23       118       7       (51     337       (247     2,855  

EPS - Diluted

    0.38       0.72       0.65       0.53       0.01       0.12       0.02       0.11       0.01       (0.05     0.30       (0.22     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, primarily related to the rationalization of our plants and other unusual events.

 

Adjusted EBITDA reconciliation    

  

Net income (loss)

     456  

Add:

  

Financial expenses

     1,058  

Income taxes

     211  

Share in profits (losses) of associated companies – net

     (9

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  
  

 

 

 

 

*

Includes other items primarily related to the rationalization of our plants and other exceptional events.

 

9


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
       

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

Financial expenses

    834                             (85     918  

Income taxes

    (168                           (745     577  

Gross profit

    7,726       894                 23       27           63         8,734  

Gross profit margin

    46.4                             52.4

Operating income (loss)

    (3,572     1,020       60       4,628       1,918       37       120       23       129       (81     (8     114       —         4,388  

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 - Diluted

    (3.63     0.93       0.05       4.21       1.75       0.03       0.11       0.02       0.12       (0.07     (0.01     0.10       (1.04     2.58  

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, primarily related to the rationalization of our plants and other unusual events.

 

Adjusted EBITDA reconciliation       

Net income (loss)

     (4,099

Add:

  

Financial expenses

     834  

Income taxes

     (168

Share in profits (losses) of associated companies – net

     (138

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 costs

     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 $18 million)*

     93  
  

 

 

 

Adjusted EBITDA

     4,912  
  

 

 

 

 

*

Includes other items primarily related to the rationalization of our plants and other exceptional events.

 

10

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