SEC Company Response from TEVA PHARMACEUTICAL INDUSTRIES LTD (TEVA, TEVJF) (CIK 0000818686) (TEVA) — Apr 23, 2012
TEVA PHARMACEUTICAL INDUSTRIES LTD (TEVA, TEVJF) (CIK 0000818686)
Date: April 23, 2012 · CIK: 0000818686 · Accession: 0000899140-12-000276
AI Filing Summary & Sentiment
File numbers found in text: 000-16174
Referenced dates: April 10, 2012
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VIA EDGAR
April 23, 2012
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jim B. Rosenberg, Senior Assistant Chief Accountant
Division of Corporation Finance
Re:
Teva Pharmaceutical Industries Limited
Form 20-F for the Fiscal Year Ended December 31, 2011 (the “2011 Form 20-F”)
Filed February 17, 2012
File No. 000-16174
Dear Mr. Rosenberg:
On behalf of Teva Pharmaceutical Industries Limited (“Teva” or the “Company”), set forth below are Teva’s responses to the comments of the staff (the “Staff”) of the Securities and Exchange Commission contained in your letter dated April 10, 2012 to Eyal Desheh, Teva’s Chief Financial Officer. For your convenience, we have set forth below the Staff’s comments in italics, followed by Teva’s responses thereto. Please also see the separate letter of Mr. Desheh being submitted concurrently with this response letter containing Teva’s “Tandy letter” acknowledgment.
As further described below, we propose to make any changes to our disclosure commencing either with our Form 6-K with respect to our quarter ending March 31, 2012 (the “1Q Form 6-K”) or our Form 20-F for the fiscal year ending December 31, 2012 (the “2012 Form 20-F”).
Item 4: Information on the Company
Regulation
Government Reimbursement Programs, page 48
1.
You have disclosed several changes due to the Healthcare Reform Act that may affect your financial statements including increasing Medicaid rebates, narrowing sales definitions for average manufacturer price purposes and expanding Medicaid rebates to cover Medicaid managed care programs. You also disclose that under the new legislation, certain pharmaceutical companies are now obligated to fund 50% of the patient obligation in the “donut hole.” Additionally, you indicate that commencing in 2011, an excise tax was levied against certain branded pharmaceutical products to be apportioned to qualifying pharmaceutical companies across the industry based on an allocation of their governmental programs as a portion of total pharmaceutical government programs.
Mr. Jim B. Rosenberg
Securities and Exchange Commission
April 23, 2012
Page 2
Please provide us proposed accounting policy disclosures to be included in your financial statements in future periodic reports regarding these changes. For example, disclose how you are recording the amounts due for the excise tax assessed to pharmaceuticals and where the amounts are classified in the income statement. In addition, please provide us proposed disclosure to be included in future periodic reports for Management’s Discussion and Analysis of the effects the Healthcare Reform Act had on your liquidity and results of operations for each period presented and the anticipated effects the legislation will have on your future liquidity and results of operations. For example, consider disclosing, if known, your anticipated share of the excise tax that will be levied on your current and future results of operations as well as any other anticipated effects on your results of operations of other changes in the law.
The annual fee assessed to pharmaceutical manufacturers (the brand manufacturer’s fee, or “excise tax”) has been accounted for ratably throughout the year in Selling and Marketing expenses in accordance with ASU Topic 720-50. The amount for the fiscal year ended December 31, 2011 was $6 million, or 0.2% of Selling and Marketing expenses. As this fee did not have a significant impact on our results of operations for the year ended December 31, 2011 and we do not expect the fee to have a significant impact on future operations, there was no specific disclosure provided as to the amount or accounting policy. We will continue to monitor this annual fee and will consider additional disclosure if the amounts have or are expected to have a significant impact on our operations.
We recorded an additional $255 million and $169 million in 2011 and 2010, respectively, as sales reserves and allowances related to increased, extended and expanded rebate provisions, including the Medicare coverage gap, or “donut hole.” These amounts, which are included in the Sales Reserves and Allowances table on page 75 of our 2011 Form 20-F as a component of Rebates and Other Sales Reserves and Allowances, represented 3% of total provisions for 2011 and 2010 and 8% and 6% of rebates and other provisions for 2011 and 2010, respectively. We did not consider this to be a significant component of sales provisions requiring specific disclosure of the amounts; however, on page 74 of our 2011 Form 20-F, we did note that “Included in the 2011 and 2010 provisions [for Rebates and Other Sales Reserves and Allowances] are estimates for the impact of changes to Medicaid rebates and associated programs related to U.S healthcare reform.” We will continue to monitor these amounts and will consider additional disclosure if the amounts have or are expected to have a significant impact on our operations.
Mr. Jim B. Rosenberg
Securities and Exchange Commission
April 23, 2012
Page 3
Item 5: Operating and Financial Review and Prospects
Results of Operations
Gross Profit, page 64
2.
Please expand your analysis to quantify the primary factors underlying the changes in gross profit for each period presented. In particular, quantify the reduction in gross profit margins due to the fewer number of high-margin generic products and the increase in gross profit margins due to sales of higher margin innovative and branded products. Also, describe and quantify the impact of the declining sales of prior year generic drug launches, such as the 2011 decline in sales of key 2010 launches as disclosed on page 61. In addition, quantify the components of cost of sales other than the cost of inventory sold, such as amortization of purchased intangible assets and cost of regulatory actions taken in various manufacturing facilities.
In response to this comment, we will include enhanced disclosure quantifying the material factors affecting our gross profit and gross margins along the following lines (adjusted as applicable), commencing with our 1Q Form 6-K:
Gross profit margins were 52.0% in 2011, compared with 56.2% in 2010. This decrease in gross margin of 4.2% primarily reflects lower sales of generic products in the U.S., which was impacted mainly by fewer high-margin new launches of generic products (which decreased the gross margin by approximately 3.6 points) and higher charges related to the amortization of purchased intangible assets, inventory step-up and regulatory actions taken in various manufacturing facilities (which decreased the gross margin by approximately 3.2 points), as well as higher sales of products with lower gross margins (which decreased the gross margin by approximately 0.7 points). These factors were partially offset by an increase in sales of our higher margin innovative and branded products, mainly Copaxone®, Azilect®, ProAir™ and Qvar® as well as the newly acquired Cephalon products, mainly Provigil®, Treanda® and Nuvigil® (which overall increased our gross margin by approximately 3.3 points).
For the Staff’s information, we note that the impact on gross profit of amortization of purchased intangible assets was $668 million in 2011 as compared to $497 million in 2010, of inventory step-up was $352 million in 2011 as compared to $107 million in 2010, and of regulatory actions taken in various manufacturing facilities was $170 million in 2011 as compared to none in 2010.
Mr. Jim B. Rosenberg
Securities and Exchange Commission
April 23, 2012
Page 4
With the enhanced disclosure quantifying the aggregate impact of these higher charges (as set forth in the indented paragraph above), we do not believe it is material to investors to further breakdown each of these items separately.
Research and Development Expenses, page 65
3.
Please disclose the composition of the total research and development expense shown in the financial statements for each period presented based on how you manage these activities. In this regard, we believe distinguishing between discovery, preclinical and clinical development categories and further by late stage, such as phase III development categories along with providing the number of projects in each category, facilitates investors’ understanding of the pipeline and related trends. To the extent that management has information available by therapeutic class, such as the breakdown beginning on page 36, we believe that this information further enhances investors’ understanding of research and development expense and related trends.
In response to this comment, we will include enhanced disclosure regarding our R&D expenses along the following lines (adjusted as applicable), commencing with our 2012 Form 20-F:
The Company’s net research and development expenditures were $1,095 million in 2011 and $951 million in 2010. As a percentage of revenues, R&D expenditures amounted to 6.0% in 2011and 5.9% in 2010. Historically, our research and development activities have fallen into two broad categories, generic pharmaceuticals (which includes R&D for active pharmaceutical ingredients and over-the-counter products) and branded pharmaceuticals (which includes innovations in devices and delivery methods). The amount spent in each category has varied over time, partially as a result of recent acquisitions, such as that of Cephalon, Inc. (a branded pharmaceutical company) in November 2011and Barr Pharmaceuticals, Inc. (a generic pharmaceutical company) in December 2008.
Generic pharmaceutical R&D expenditures include both (a) direct expenses relating to product formulation, analytical method development, stability testing, management of bioequivalence and other clinical studies, regulatory filings and legal expenses relating to patent review and challenges, and (b) indirect expenses such as costs of internal administration, infrastructure and personnel involved in generic R&D. For the years ended December 31, 2011 and 2010, the Company’s R&D expenses related to generic pharmaceuticals were $481 million and $491 million, respectively.
Mr. Jim B. Rosenberg
Securities and Exchange Commission
April 23, 2012
Page 5
Branded pharmaceutical R&D expenditures include upfront and milestone payments for products in development phase, the costs of discovery research, preclinical development, early- and late-clinical development and drug formulation, clinical trials, product registration costs and other costs, and are reported net of contributions received from collaboration partners. Our branded R&D spending takes place at every stage, from drug discovery through pre-launch marketing activities, including (a) early-stage projects in both discovery and preclinical phases; (b) middle-stage projects in clinical programs up to phase III, and (c) late-stage projects in phase III programs, where an NDA is currently pending approval, and life cycle management studies for marketed products. We consider phase III, or late-stage development, to be our most significant R&D programs, as they could potentially affect revenues and earnings in the relatively near future. In addition, we incur indirect expenses that support our overall branded R&D efforts but which are not allocated by product or to specific R&D projects, such as the costs of internal administration, infrastructure and personnel. For the years ended December 31, 2011 and 2010, the Company’s net R&D expenses related to branded pharmaceuticals were $614 million and $460 million, respectively, including such unallocated expenses.
The following table presents the composition of our net branded R&D expenditures and the number of projects by stage of development:
Mr. Jim B. Rosenberg
Securities and Exchange Commission
April 23, 2012
Page 6
R&D Expenses
(USD in millions)
# of Projects as
of Dec 31,
2011
2011
2010
Early-stage
$75
$45
Not applicable
Middle-stage
$91
$41
18
Late-stage
$291
$252
28
Sub-total
$457
$338
Unallocated R&D (inc. R&D participation)
$157
$122
Total
$614
$460
These amounts are not necessarily predictive of future R&D expenditures. In an effort to allocate our R&D spending most effectively, we continually evaluate the products under development (whether generic or branded), based on the performance of such products in pre-clinical and/or clinical trials, our expectations regarding the likelihood of their regulatory approval and our view of their commercial viability, among other factors. We expect that our R&D expenditures will increase in absolute terms as a result of both our recent strategic acquisitions and the increase in our generic and branded product portfolio, as well as the expansion of our efforts in drug discovery and device research and development. Consequently, the composition of our research and development expenditures may change.
We do not believe that providing a further breakdown of our R&D efforts (number of projects and amount of expenditures) by therapeutic class would provide information that is material to our investors. The Company has not historically publicly disclosed such detailed information regarding its R&D portfolio, as many projects at any given time are not mature, material or otherwise appropriate for public disclosure. In addition, the disclosure of such information could cause competitive harm to the Company, as competitors or even potential collaboration partners would gain insights into our strategy and costs, enabling them to compete or negotiate with us unfairly on the basis of asymmetric information.
Mr. Jim B. Rosenberg
Securities and Exchange Commission
April 23, 2012
Page 7
4.
For projects that are in the late stage of development such as phase III as presented beginning page 36, unless management believes that the expected effect on results of operations or financial position from the project when completed will be insignificant, we believe disclosure about each project should be enhanced to provide insight into expected effects on future operations, financial position or liquidity. For those projects, we would expect the following to be discussed:
•
The month and year the project entered into the current phase of development;
•
Significant patents associated with the project and their expiration dates and/or other information, as applicable, that provides insight into the period of exclusivity available;
In response to this comment, the Company will include the following information with respect to the branded pharmaceutical products that it is developing and that are in phase III development, commencing with its 2012 Form 20-F:
•
The month and year when each product candidate entered phase III clinical trials (defined as the date of first patient enrolled); and
•
Data, including expiration dates, for important patents for significant products submitted for approval in the U.S. or Europe*.
* It is difficult to predict with certainty the length of market exclusivity for any of our branded products, because of the complex interaction between patent and regulatory forms of exclusivity and because of inherent uncertainties concerning the outcome of patent litigation. Accordingly, any disclosure in this regard will indicate that there can be no assurance of market exclusivity for the full period that we estimate.
Supplemental Non-GAAP Income Data
Reconciliation between reported Net Income attributable to Teva and Earnings per share as reported under US GAAP to Non-GAAP Net Income attributable to Teva and Earnings per share, page 70
5.
It is generally not appropriate to present a full non-GAAP income statement for purposes of reconciling non-GAAP measures to the most directly comparable GAAP measures. Presenting a full non-GAAP income statement may attach undue prominence to the non-GAAP information. Please refer to Compliance and Disclosure Interpre