CORRESP 1 filename1.htm

 

 

 

November 30, 2023

 

VIA EDGAR

 

U.S. Securities and Exchange Commission
Division of Corporation Finance, Office of Life Sciences
100 F Street, N.E.
Washington, D.C. 20549

Attention: Lynn Dicker and Tara Harkins

 

Re: Ironwood Pharmaceuticals, Inc.
  Form 10-K for Fiscal Year Ended December 31, 2022
  Form 8-K filed on February 16, 2023
  File No. 001-34620

 

Ladies and Gentlemen:

 

On behalf of Ironwood Pharmaceuticals, Inc. (the “Company”), I hereby submit this letter in response to the comment letter from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”), dated November 15, 2023, relating to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the Commission on February 16, 2023 (the “2022 Form 10-K”), and the Company’s Current Report on Form 8-K, furnished to the Commission on February 16, 2023. The Staff’s comment is presented in italics below.

 

Form 8-K filed on February 16, 2023

 

Exhibits

 

1.Within this and your September 30, 2023 earnings release you present tables for the U.S. LINZESS Commercial Collaboration and US LINZESS Full Brand Collaboration Revenue/Expense Calculations. Please tell us how these tables reconcile to your annual and quarterly GAAP financial statements and quantify for us the differences, if necessary. Within your response, clearly explain what these tables represent; and tell us why you are presenting this information.

 

Pursuant to its collaboration (the “Collaboration”) with AbbVie Inc. (together with its affiliates, “AbbVie”) for the development and commercialization of linaclotide in North America, the Company receives 50% of the net profits and bears 50% of the net losses from commercial sales of LINZESS (the U.S. marketing name for linaclotide) in the United States. LINZESS net sales are calculated and recorded by AbbVie using AbbVie’s revenue recognition accounting policies and reporting conventions. As set forth in the Company’s earnings releases, the U.S. LINZESS Commercial Collaboration table presents the calculation of the Company’s share of net profit (loss) generated from the sale of LINZESS in the United States and the Company’s Collaboration revenue/expense. This table does not present the research and development (“R&D”) expenses related to LINZESS in the United States that are shared equally between the Company and AbbVie. Also as set forth in the Company’s earnings releases, the U.S. LINZESS Full Brand Collaboration table presents calculations of the total net profit (loss) generated from the sales of LINZESS in the United States, including the commercial costs and expenses and the R&D expenses related to LINZESS in the United States that are shared equally between the Company and AbbVie.

 

 

 

 

 

 

 

Reconciliation to Financial Statements

 

U.S. LINZESS Commercial Collaboration

 

Fiscal Year and Quarterly Period Ended December 31, 2022

 

U.S. LINZESS Commercial Collaboration1

Revenue/Expense Calculation

(In thousands)

(unaudited)

 

   Three Months Ended
December 31,
   Twelve Months Ended
December 31,
 
   2022   2021   2022   2021 
LINZESS U.S. net sales as reported by AbbVie2  $260,327   $278,555   $1,002,143   $1,005,856 
AbbVie & Ironwood commercial costs, expenses and other discounts3   66,879    67,510    272,757    265,118 
Commercial profit on sales of LINZESS  $193,448   $211,045   $729,386   $740,738 
Commercial Margin4   74%   76%   73%   74%
Ironwood’s share of net profit   96,724    105,523    364,693    370,369 
Reimbursement for Ironwood’s commercial expenses   8,048    8,199    34,074    30,002 
Ironwood’s collaborative arrangement revenue2  $104,772   $113,722   $398,767   $400,371 

 

As shown above, “Ironwood’s collaborative arrangement revenue,” included in the U.S. LINZESS Commercial Collaboration table in the Company’s earnings release for the fiscal year and quarterly period ended December 31, 2022, agrees to the “Collaborative arrangements revenue related to sales of LINZESS in the U.S.” in the table summarizing collaborative arrangements revenue from the Collaboration, included under Note 4—Collaboration, License and Other Agreements (“Note 4”) to the Company’s Consolidated Financial Statements, on page F-20 of the 2022 Form 10-K, as shown below. Because AbbVie, and not the Company, records net sales of LINZESS in the United States, “LINZESS U.S. net sales as reported by AbbVie,” as well as the subsequent line items used to calculate “Ironwood’s collaborative arrangement revenue”, do not correspond to specific line items on the Company’s financial statements.

 

 

 

 

 

 

The Company recognized collaborative arrangements revenue from the Collaboration for North America during the years ended December 31, 2022, 2021, and 2020 as follows (in thousands):

 

   Year Ended December 31, 
   2022   2021   2020 
Collaborative arrangements revenue related to sales of LINZESS in the U.S.  $398,767   $400,371   $368,603 
Royalty revenue   2,731    2,714    2,299 
Total collaborative arrangements revenue  $401,498   $403,085   $370,902 

 

As shown above and presented in Note 4 on page F-20, “Royalty revenue” is added to “Collaborative arrangements revenue related to sales of LINZESS in the U.S.,” resulting in “Total collaborative arrangements revenue” related to the Collaboration. “Total collaborative arrangements revenue” from the Collaboration agrees to “AbbVie (North America)” under “Linaclotide Collaboration and License Agreements” in the Collaborative Arrangements Revenue table in Note 4, on page F-19 of the 2022 Form 10-K and as shown below. Revenues from the Company’s other collaborative arrangements are added to “AbbVie (North America),” resulting in “Total collaborative arrangements revenue.”

 

   Year Ended December 31, 
Collaborative Arrangements Revenue  2022   2021   2020 
Linaclotide Collaboration and License Agreements:               
AbbVie (North America)  $401,498   $403,085   $370,902 
AbbVie (Europe and other)   2,444    2,558    2,196 
AstraZeneca (China, including Hong Kong and Macau)   635    743    682 
Astellas (Japan)   2,001    2,232    2,128 
Other Agreements:               
Alnylam (GIVLAARI)   2,194    2,411    4,302 
Other   1,824    1,755    1,335 
Total collaborative arrangements revenue  $410,596   $412,784   $381,545 
Sale of API               
Linaclotide Agreements:               
Astellas (Japan)  $-   $149   $2,017 
AstraZeneca (China, including Hong Kong and Macau)   -    597    5,540 
Other   -    223    421 
Total sale of API  $-   $969   $7,978 

 

“Total collaborative arrangements revenue” in the above table agrees to “Collaborative arrangements revenue” under “Revenues” on the face of the Company’s Consolidated Statements of Income and Comprehensive Income, presented on page F-5 of the 2022 Form 10-K and as shown below.

 

 

 

 

 

 

Ironwood Pharmaceuticals, Inc.
Consolidated Statements of Income and Comprehensive Income
(In thousands, except per share amounts)

 

   Years Ended December 31, 
   2022   2021   2020 
Revenues:            
Collaborative arrangements revenue  $410,596   $412,784   $381,545 
Sale of active pharmaceutical ingredient   -    969    7,978 
Total revenues   410,596    413,753    389,523 
Operating expenses:               
Cost of revenues   -    -    3,136 
Research and development   44,265    70,405    88,062 
Selling, general and administrative   115,994    111,133    140,003 
Restructuring expenses   -    (44)   15,382 
Total operating expenses   160,259    181,494    246,583 
Income from operations   250,337    232,259    142,940 
Other (expense) income:               
Interest expense   (7,598)   (31,150)   (29,478)
Interest and investment income   9,501    726    1,504 
Gain (loss) on derivatives   182    (1,178)   (6,129)
Other income   -    -    24 
Other (expense) income, net   2,085    (31,602)   (34,079)
Income before income taxes   252,422    200,657    108,861 
Income tax (expense) benefit   (77,357)   327,791    (2,685)
Net income and comprehensive income  $175,065   $528,448   $106,176 
Net income per share-basic  $1.13   $3.26   $0.67 
Net income per share-diluted  $0.96   $3.21   $0.66 
Weighted average shares used in computing net income per share-basic:   154,366    162,245    159,427 
Weighted average shares used in computing net income per share-diluted:   186,312    164,418    160,655 

 

Quarterly Period Ended September 30, 2023

 

U.S. LINZESS Commercial Collaboration1

Revenue/Expense Calculation

(In thousands)

(unaudited)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
LINZESS U.S. net sales as reported by AbbVie2  $278,954   $261,131   $798,854   $741,816 
AbbVie & Ironwood commercial costs, expenses and other discounts3   77,736    68,499    223,142    205,878 
Commercial profit on sales of LINZESS  $201,218   $192,632   $575,712   $535,938 
Commercial Margin4   72%   74%   72%   72%
Ironwood’s share of net profit   100,609    96,316    287,856    267,969 
Reimbursement for Ironwood’s commercial expenses   9,480    8,908    28,615    26,026 
Ironwood’s collaborative arrangement revenue  $110,089   $105,224   $316,471   $293,995 

 

Similarly, as shown above, “Ironwood’s collaborative arrangement revenue,” included in the U.S. LINZESS Commercial Collaboration table presented in the Company’s earnings release for the quarterly period ended September 30, 2023, agrees to “Collaborative arrangements revenue related to sales of LINZESS in the U.S.,” presented in the table summarizing collaborative arrangements revenue from the Collaboration, included under Note 5—Collaboration, License and Other Agreements (“Note 5”) to the Company’s Consolidated Financial Statements, on page 17 of the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2023, filed with the Commission on November 9, 2023 (the “Q3 2023 Form 10-Q”), as shown below.

 

 

 

 

 

 

The following table summarizes collaborative arrangements revenue from the Collaboration for North America (in thousands):

 

   Three Months Ended   Nine Months Ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
Collaborative arrangements revenue related to sales of LINZESS in the U.S.  $110,089   $105,224   $316,476   $293,995 
Royalty revenue   641    861    2,072    2,052 
Total collaborative arrangements revenue  $110,730   $106,085   $318,548   $296,047 

 

As shown above and presented in Note 5 on page 17, “Royalty revenue” is added to “Collaborative arrangements revenue related to sales of LINZESS in the U.S.,” resulting in “Total collaborative arrangements revenue.” “Total collaborative arrangements revenue” from the Collaboration agrees to “AbbVie (North America)” under “Linaclotide Collaboration and License Agreements” in the Collaborative Arrangements Revenue table included under Note 5, on page 16 of the Q3 2023 Form 10-Q and as shown below. Revenues from the Company’s other collaborative arrangements are added to “AbbVie (North America),” resulting in “Total collaborative arrangements revenue.”

 

   Three Months Ended   Nine Months Ended 
   September 30,   September 30, 
Collaborative Arrangements Revenue  2023   2022   2023   2022 
Linaclotide Collaboration and License Agreements:                    
AbbVie (North America)  $110,730   $106,085   $318,548   $296,047 
AbbVie (Europe and other)   714    709    2,071    1,847 
AstraZeneca (China, including Hong Kong and Macau)   174    144    386    484 
Astellas (Japan)   432    520    1,305    1,543 
Other Agreements:                    
Alnylam (GIVLAARI)   -    814    -    2,222 
AKP (apraglutide)   934    -    997    - 
Other   755    365    1,875    1,254 
Total collaborative arrangements revenue  $113,739   $108,637   $325,182   $303,397 

 

“Total collaborative arrangements revenue” from the above table agrees to “Collaborative arrangements revenue” under “Revenues” on the face of the Company’s Condensed Consolidated Statements of Income (Loss), presented on page 6 of the Q3 2023 Form 10-Q and as shown below.

 

 

 

 

 

 

Ironwood Pharmaceuticals, Inc.

Condensed Consolidated Statements of Income (Loss)

(In thousands, except per share amounts)

(unaudited)

 

   Three Months Ended   Nine Months Ended 
   September 30,   September 30, 
   2023   2022   2023   2022 
Revenues:                
Collaborative arrangements revenue  $113,739   $108,637   $325,182   $303,397 
Total revenues   113,739    108,637    325,182    303,397 
Costs and expenses:                    
Research and development   32,985    11,545    80,409    33,819 
Selling, general and administrative   36,046    28,619    119,647    87,604 
Restructuring expenses   4,685    -    17,696    - 
Acquired in-process research and development   -    -    1,090,449    - 
Total costs and expenses   73,716    40,164    1,308,201    121,423 
Income (loss) from operations   40,023    68,473    (983,019)   181,974 
Other income (expense):                    
Interest expense and other financing costs   (9,839)   (1,524)   (13,206)   (6,072)
Interest and investment income   1,748    2,807    17,777    4,055 
Gain on derivatives   -    151    19    200 
Other income (expense), net   (8,091)   1,434    4,590    (1,817)
Income (loss) before income taxes   31,932    69,907    (978,429)   180,157 
Income tax expense   (17,982)   (19,590)   (51,385)   (53,959)
Net income (loss)   13,950    50,317    (1,029,814)   126,198 
Less: Net income (loss) attributable to noncontrolling interests   (1,371)   -    (28,662)   - 
Net income (loss) attributable to Ironwood Pharmaceuticals, Inc.  $15,321   $50,317   $(1,001,152)  $126,198 
Net income (loss) per share attributable to Ironwood Pharmaceuticals, Inc. shareholders -basic  $0.10   $0.33   $(6.45)  $0.82 
Net income (loss) per share attributable to Ironwood Pharmaceuticals, Inc. shareholders -diluted  $0.09   $0.28   $(6.45)  $0.69 
Weighted average shares used in computing net income (loss) per share attributable to Ironwood Pharmaceuticals, Inc. shareholders-basic:   155,886    153,066    155,240    154,713 
Weighted average shares used in computing net income (loss) per share attributable to Ironwood Pharmaceuticals, Inc. shareholders-diluted:   186,891    184,465    155,240    186,504 

 

U.S. LINZESS Full Brand Collaboration

 

Fiscal Year and Quarterly Period Ended December 31, 2022

 

US LINZESS Full Brand Collaboration1

Revenue/Expense Calculation

(In thousands)

(unaudited)

 

   Three Months Ended
December 31,
   Twelve Months Ended
December 31,
 
   2022   2021   2022   2021 
LINZESS U.S. net sales as reported by AbbVie  $260,327   $278,555   $1,002,143   $1,005,856 
AbbVie & Ironwood commercial costs, expenses and other discounts3   66,879    67,510    272,757    265,118 
AbbVie & Ironwood R&D Expenses4   9,684    11,017    33,684    39,417 
Total net profit on sales of LINZESS  $183,764   $200,028   $695,702   $701,321 

 

 

 

 

 

 

Quarterly Period Ended September 30, 2023

 

US LINZESS Full Brand Collaboration1

Revenue/Expense Calculation

(In thousands)

(unaudited)

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2023   2022   2023   2022 
LINZESS U.S. net sales as reported by AbbVie2  $278,954   $261,131   $798,854   $741,816 
AbbVie & Ironwood commercial costs, expenses and other discounts3   77,736    68,499    223,142    205,878 
AbbVie & Ironwood R&D Expenses4   9,264    7,620    28,270    24,000 
Total net profit on sales of LINZESS  $191,954   $185,012   $547,442   $511,938 

 

“LINZESS U.S. net sales as reported by AbbVie” and “AbbVie & Ironwood commercial costs, expenses and other discounts,” included in the U.S. LINZESS Full Brand Collaboration table in the Company’s earnings releases and as shown above, agree to the corresponding line items included in the U.S. LINZESS Commercial Collaboration table presented in the Company’s earnings releases and used to calculate certain measures in the Company’s financial statements, as outlined above.

 

“AbbVie & Ironwood R&D Expenses” represent the combined R&D expenses of the Company and AbbVie in connection with the Collaboration, which expenses are shared equally by the Company and AbbVie. The amount presented in “AbbVie & Ironwood R&D Expenses” is not discretely reported in the Company’s Consolidated Financial Statements, but 50% of such amounts are included within the broader “Research and development” line item under “Costs and expenses” presented in the Company’s income statements. The amount presented in “Total net profit on sales of LINZESS” is also not discretely reported in the Company’s Consolidated Financial Statements, but, as outlined above, the inputs to this line item are calculated in the same manner as the corresponding measures in the Company’s financial statements.

 

Why the Company Presents this Information

 

The Company discloses the U.S. LINZESS Commercial Collaboration and U.S. LINZESS Full Brand Collaboration tables because it believes they present useful information for investors evaluating the Collaboration and its impact on the Company. The Company’s interest in the Collaboration is one of its most important assets. Accordingly, there is significant investor focus on the Company’s collaborative arrangements revenue, and the Company believes it is useful for investors to see a breakdown of how this measure is calculated, as shown in the U.S. LINZESS Commercial Collaboration table.

 

 

 

 

 

 

Because the U.S. LINZESS Commercial Collaboration table and the collaborative arrangements revenue line item do not give effect to R&D expenses, the U.S. LINZESS Full Brand Collaboration table provides useful incremental information to investors regarding the total Collaboration profitability. In connection with the Collaboration, the Company and AbbVie jointly collaborate on the management of LINZESS through a joint commercial committee and a joint development committee. When making decisions regarding the Collaboration and the Company’s strategy, the Company’s management evaluates profitability of the Collaboration based on a fulsome evaluation of revenues and expenses, including R&D expenses. The U.S. LINZESS Full Brand Collaboration therefore allows investors to analyze the LINZESS brand from the perspective of the Company’s management. Because AbbVie, and not the Company, records net sales of LINZESS in the United States, this would not be possible without this supplement disclosure.

 

*      *      *

 

Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact me at (617) 375-5055.

 

  Sincerely,
   
  /s/ Sravan K. Emany
  Sravan K. Emany
  Senior Vice President, Chief Financial Officer

 

cc:John Minardo, Senior Vice President, Chief Legal Officer and Secretary

Paul M. Kinsella, Ropes & Gray LLP 

William J. Michener, Ropes & Gray LLP