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
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File numbers found in text: 001-34620
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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