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Correspondence 0001104659-23-122436 from IRONWOOD PHARMACEUTICALS INC (IRWD) (CIK 0001446847) (IRWD)

IRONWOOD PHARMACEUTICALS INC (IRWD) (CIK 0001446847)
Date: Nov. 30, 2023 · CIK: 0001446847 · Accession: 0001104659-23-122436

AI Filing Summary & Sentiment

File numbers found in text: 001-34620

Date
November 30, 2023
Author
Not clearly detected
Form
CORRESP
Company
IRONWOOD PHARMACEUTICALS INC (IRWD) (CIK 0001446847)

Letter

Re: Ironwood Pharmaceuticals, Inc.

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

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,

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,

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

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)

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) - 5,540

Other -

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,

Revenues:

Collaborative arrangements revenue $ 410,596 $ 412,784 $ 381,545

Sale of active pharmaceutical ingredient - 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 1,504

Gain (loss) on derivatives (1,178 ) (6,129 )

Other income - -

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,

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,

Collaborative arrangements revenue related to sales of LINZESS in the U.S. $ 110,089 $ 105,224 $ 316,476 $ 293,995

Royalty revenue 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

Linaclotide Collaboration and License Agreements:

AbbVie (North America) $ 110,730 $ 106,085 $ 318,548 $ 296,047

AbbVie (Europe and other) 2,071 1,847

AstraZeneca (China, including Hong Kong and Macau)

Astellas (Japan) 1,305 1,543

Other Agreements:

Alnylam (GIVLAARI) - - 2,222

AKP (apraglutide) - -

Other 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,

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 -

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,

LINZESS U.S. net sales as reported by AbbVie $ 260,327 $ 278,555 $ 1,002,143 $ 1,005,856

AbbVie & Ironwood commercial costs

Show Raw Text
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