SecProbe.io

Filing text and metadata
Intelligence Terminal Search Probe Scores Topics IPO Watchlist Monthly Activity About API

SEC Comment Letter for TEVA PHARMACEUTICAL INDUSTRIES LTD (TEVA, TEVJF) (CIK 0000818686) (TEVA) — Mar 20, 2013

TEVA PHARMACEUTICAL INDUSTRIES LTD (TEVA, TEVJF) (CIK 0000818686)
Date: March 20, 2013 · CIK: 0000818686 · Accession: 0000000000-13-014682

AI Filing Summary & Sentiment

File numbers found in text: 001-16174

Date
December 31, 2012
Author
/s/ Jim B. Rosenberg
Form
UPLOAD
Company
TEVA PHARMACEUTICAL INDUSTRIES LTD (TEVA, TEVJF) (CIK 0000818686)

Letter

March 1 9, 201 3 Via E -mail Mr. Eyal Desheh Chief Financial Officer Teva Pharmaceutical Industries Limited 5 Basel Street P.O. Box 3190 Petach Tikva 49131, Israel

Re: Teva Pharmaceuticals Industries Limited Form 20-F for the Fiscal Year Ended December 31, 2012 Filed February 12 , 201 3 File No. 001-16174

Dear Mr . Desheh :

We have limited our review to only your financial statements and related disclosures and do not intend to expand our review to other portions of your document. In our comments, we ask you to provide us with information so we may better understand your disclosure.

Please respond to this letter within 10 business days by providing the requ ested information or by advising us when you will provide the requested response . If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. Please furnish us a letter on EDGAR under the form type label CORRESP that key s your response s to our comments.

After reviewing the information you provide in response to these comments , we may have additional comments and/or request that you amend your filing.

Specialty Products Central Nervous System, page 22

1. You disclose, on page 22, that the Orange Book patent will expire on May 21, 2014 and on page F -36 that competitors have submitted ANDAs for generic version of Copaxone. Given that revenue for Copaxone was approximately $4 billion, $2.9 billion in the Uni ted States, the loss of patent could have a material impact on your future financial results, please provide us revised disclosure to include in future periodic reports which discusses in quantitative and qualitative terms, the impact that expirations of t he Orange Book patent to Copaxone in the United States in 2014 and in most of the rest of the world in May 2015 will have on your results of operations and liquidity in future periods. Please include in your discussion the ease or difficulty for other com panies to develop competing branded or generic products. To the extent that you are aware of any competitors’ products in development and nearing

Mr. Eyal Desheh Teva Pharmaceutical Industries Limited March 1 9, 201 3 Page 2

commercialization that are expected to compete with Copaxone when exclusivity ends in the next three years, p lease disclose as applicable.

Results of Operations Revenues - Europe - Specialty Medicines, page 63

2. Throughout MD&A, when more than one factor has resulted in an increase or decrease, quantify the effect of each. For example, you disclose here: “ Reve nues from specialty medicines in Europe in 2012 amounted to $1.6 billion, an increase of 42% compared to 2011. In local currency terms, sales increased by 53%, primarily driven by the inclusion of full year sales of Cephalon, the completion of the transiti on of the distribution and marketing rights for Copaxone to us from Sanofi, and the launch of Zoely.” Confirm that you will quantify each factor underlying changes in future filings.

Research and Development (R&D) Expenses, page 70

3. In response to our review of your Form 20 -F for the fiscal period ended December 31, 2011 you responded in correspondence dated April 23, 2012, that you would include expanded disclosure regarding your R&D expenses including a table of branded R&D expense and number of proje cts by development phase in future filings. We did not note this information in our review of your Form 20 -F for the fiscal period ended December 31, 2012. Please provide this information in future filings or tell us why you beli eve this information is n ot warranted.

Note 2 - Certain Transactions 2) South Korea venture, page F -18

4. Please tell us how you will be accounting for the agreement you entered into with Handok Pharmaceutical Co and whether the venture is a variable interest entity and you are the primary beneficiary and why or why not.

Note 17 – Impairments, Loss Contingencies, Restr ucturing and Others, page F -52

5. Please provide us revised disclo sure to include in future periodic reports that states the factors contributi ng to the write downs of in-process R&D, existing product rights and property, plant and equipment. Refer to ASC 350 -30-50-3 and 360 -10-50-2.

We urge all persons who are responsible for the accuracy and a dequacy of the disclosure in the filing to be certain that the filing include s the information the Securities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made.

Mr. Eyal Desheh Teva Pharmaceutical Industries Limited March 1 9, 201 3 Page 3

In responding to our comments, please provide a written statement from the company acknowledging that:  the company is responsible for the adequacy and accuracy of the disc losure in the filing;  staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to th e filing; and  the company may not assert staff comments as a defense in any proceeding init iated by the Commission or any person under the federal securities laws of the United States.

You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Lisa Vanjoske , Assistant Chief Accountant , at (202) 551-3614 if you have questions regarding t hese comments. In this regard, do not hesitate to contact me at (202) 551 -3679.

Sincerely,
/s/ Jim B. Rosenberg

Show Raw Text
March 1 9, 201 3

Via E -mail
Mr. Eyal Desheh
Chief Financial Officer
Teva Pharmaceutical Industries Limited
5 Basel Street
P.O. Box 3190
Petach Tikva 49131, Israel

Re:  Teva  Pharmaceuticals Industries Limited
Form 20-F for the Fiscal Year Ended December 31, 2012
Filed February 12 , 201 3
  File No.  001-16174

Dear Mr . Desheh :

We have limited our review to only your financial statements and related disclosures and
do not intend to expand our review to other portions of your document.  In our comments, we ask
you to provide us with information so we may better understand your disclosure.

Please respond to this letter within 10 business days by providing the requ ested
information or by advising us when you will provide the requested response .  If you  do not
believe a comment applies to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP that key s your
response s to our comments.

After reviewing the information you provide in response to these comments , we may
have  additional comments  and/or request that you amend your filing.

Specialty Products
Central Nervous System, page 22

1. You disclose, on page 22, that  the Orange Book patent will expire on May 21, 2014 and on
page F -36 that competitors have submitted ANDAs for generic version of Copaxone.  Given
that revenue for Copaxone was approximately $4 billion, $2.9 billion in the Uni ted States,
the loss of patent could have a material impact on your future financial results, please provide
us revised disclosure to include in future periodic reports which discusses in quantitative and
qualitative terms, the impact that expirations of t he Orange Book patent to Copaxone in the
United States in 2014 and in most of the rest of the world in May 2015 will have on your
results of operations and liquidity in future periods.  Please include in your discussion the
ease or difficulty for other com panies to develop competing branded or generic products.   To
the extent that you are aware of any competitors’ products in development and nearing

Mr. Eyal Desheh
Teva Pharmaceutical Industries Limited
March 1 9, 201 3
Page 2

 commercialization that are expected to compete with Copaxone when exclusivity ends in the
next three years, p lease disclose as applicable.

Results of Operations
Revenues - Europe - Specialty Medicines, page 63

2. Throughout MD&A, when more than one factor has resulted in an increase or decrease,
quantify the effect of each.  For example, you disclose here: “ Reve nues from specialty
medicines in Europe in 2012 amounted to $1.6 billion, an increase of 42% compared to 2011.
In local currency terms, sales increased by 53%, primarily driven by the inclusion of full year
sales of Cephalon, the completion of the transiti on of the distribution and marketing rights
for Copaxone to us from Sanofi, and the launch of Zoely.”  Confirm that you will quantify
each factor underlying changes in future filings.

Research and Development  (R&D) Expenses, page 70

3. In response to our review of your Form 20 -F for the fiscal period ended December 31, 2011
you responded in correspondence dated April 23, 2012, that you would include expanded
disclosure regarding your R&D expenses including a table of branded R&D expense and
number of proje cts by development phase in future filings.  We did not note this information
in our review of your Form 20 -F for the fiscal period ended December 31, 2012.  Please
provide this information in future filings or tell us why you beli eve this information is n ot
warranted.

Note 2 - Certain Transactions
2) South Korea venture, page F -18

4. Please tell us how you will be accounting for the agreement you entered into with Handok
Pharmaceutical Co and whether the venture is a variable interest entity and you are the
primary beneficiary and why or why not.

Note 17 – Impairments, Loss Contingencies, Restr ucturing and Others, page F -52

5. Please provide us revised disclo sure to include in future periodic reports that states the
factors contributi ng to the write downs of  in-process R&D, existing product rights and
property, plant and equipment.   Refer to ASC 350 -30-50-3 and 360 -10-50-2.

We urge all persons who are responsible for the accuracy and a dequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules require.   Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Mr. Eyal Desheh
Teva Pharmaceutical Industries Limited
March 1 9, 201 3
Page 3

 In responding to our comments, please provide  a written statement from the company
acknowledging that:
 the company is responsible for the adequacy and accuracy of the disc losure in the
filing;
 staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any  action with respect to th e filing; and
 the company may not assert staff comments as a defense in any proceeding init iated
by the Commission or any person under the federal securities laws of the United
States.

You may c ontact Dana Hartz, Staff Accountant, at (202) 551 -3648 or Lisa Vanjoske ,
Assistant Chief Accountant , at (202) 551-3614 if you have questions regarding t hese comments.
In this regard, do not hesitate to contact me at (202) 551 -3679.

Sincerely,

 /s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief Accountant