Ironwood Pharmaceuticals : Q1 2025 Update
IRWD
Published on 05/07/2025 at 07:13
May 7, 2025
1
Focused on delivering life changing therapies for people living with gastrointestinal and rare disease
Advancing Apraglutide
Once-weekly GLP-2 Apraglutide generated strong safety and efficacy data in the largest SBS-IF trial to date (STARS Phase 3)
Long-term extension (STARS Extend) data showed 27 apraglutide-dosed patients achieved enteral autonomy, the ultimate goal of SBS-IF patients
Confirmatory Phase 3 trial is needed to seek FDA approval for apraglutide for short bowel syndrome patients dependent on parenteral support
Plan to work with the FDA on confirmatory Phase 3 trial design and regulatory path forward
Plan to continue STARS Extend trial, which with data from the STARS trial, we believe will continue to be an integral part of an NDA submission
Maximizing LINZESS
Q1 LINZESS U.S. net sales of $138.5 million: 8% 2024 year-over-year EUTRx demand growth1 more than offset by anticipated pricing headwinds and a change in estimate of AbbVie gross-to-net rebate reserves2
Reiterated full-year LINZESS U.S. Net Sales guidance of $800 - $850 million
Delivering Sustained Profits and Cash Flows
Generated $20 million of operating cash flow in Q1 2025
Ended Q1 2025 with $108 million in cash and cash equivalents
Raised full-year adjusted EBITDA3 guidance to greater than $105 million
Engaged Goldman Sachs to explore strategic alternatives
3 1 IQVIA Nation al P rescrip tion Au dit, Q1 2025 . 2 LINZESS U.S. ne t sales for three months en ded March 31, 202 5 impa cted by a chang e in estimate of AbbVie gr oss -to-net rebate reserves, which reflects r ebatesowed for units dispensed in the first qu arter of 202 5. Ironwood doe s not exp ect fir st quarter LINZESS U.S. net sa les results or this chang e in estimate to impact the full year 2025 re sults. 3 Refer to the Recon ciliation of Q1 2025 GAAP net income to a djusted EBITDA on slide 10 of this presentation.
Continued strong prescription demand growth to start 2025
20.0
70,000
60,000
18.0
50,000
NBRx Volume
16.0
EUTRx
(millions)
40,000
14.0
30,000
20,000
12.0
10,000
10.0
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec 0
2022 2023 2024 2025
Source: IQVIA Monthly National Prescription Audit Source: Weekly Patient Insights
Q1 2025 financial summary
Commercial Profit & Collaboration Revenue1
Three Months Ended
Three Months Ended
March 31, 2025
(000s)
March 31, 2024
(000s)
LINZESS U.S. net product sales as reported by AbbVie2,3
$ 138,477
$ 256,600
AbbVie & Ironwood commercial costs, expenses and other discounts4
66,907
73,362
Commercial profit on sales of LINZESS
$ 71,570
$ 183,238
Commercial Margin5
52%
71%
Ironwood's share of net profit
35,785
91,619
Reimbursement for Ironwood's commercial expenses6
2,983
10,096
Ironwood's portion of gross-to-net change in estimate7
-
(30,000)
Ironwood's collaborative arrangements revenue
$ 38,768
$ 71,715
1 Ironwood collaborates with Abb Vie on the development and commercialization of linaclotide in North America. Under the terms of the collaboration agr eement, Ironwood receives 5 0% of the net profits and bear s 50% of the net losses
from the commercial sale of LINZESS in the U.S. The pur pose of this table is to present calculations of Ironwood 's share of n et profit (loss) generated from the sales of LINZESS in the U.S. and Ironwood's collaboration revenue/expense; however, the table doe s not present the resear ch and de velo pment expen ses related to LINZESS in the U.S. that a re sha red equa lly between the parties un der the collab oration agree ment. Please refer to slide 11 of this presentation for net profit for the U.S. LINZESS brand collabo ration with AbbVie . 2 LINZESS net sales a re recognized using AbbVie's revenue recogn ition accounting policies a nd reporting conventions. As a result, certain reb ates and discounts are
classified as LINZESS U.S. commercial costs, expenses and other discou nts within Ironwood's calcula tion of collaborative arra ngements re ven ue. 3LINZESS U.S. net sales for three months ended March 31, 2025 impa cted by a change in estima te of AbbVie gro ss-to-net rebate reserves, which refle cts re bates owed for units dispensed in the first qu arter of 202 5. I ron woo d d oes no t expect first quar ter LINZESS U.S. net sales r esu lts or this ch ange in estimate to impact the full yea r 2 025 results. 4 Includes certain discounts recogn ized an d cost of goods so ld in cur red by Ab bVie; a lso includes commer cial costs incu rred by A bbVie and Ironwood that are attrib uta ble to the cost-sharing ar rangemen t between the
5 par ties. 5 Commercial mar gin is defined as commercial profit on sales of LINZESS as a percent of total LINZESS U.S. net sales. 6 Yea r-over-year decrease reflects impact of the red uction to Iro nwo od's commercial expenses and
correspon ding reimbursement fr om Ab bVie due to Iron woo d's strate gic reo rganization annou nced in Janua ry 202 5. 7 Based on information provided by AbbVie , Ironwood estimates a $ 60.0 million LINZESS gross-to-net ch ange related to
the ye ar ended December 31, 2023, a nd has re cor ded a $30.0 millio n r eductio n to collabora tive arran gements revenu e in its first qua rter 2 024 fin ancial statements to refle ct this ch ange in estimate.
Disclaimer
Ironwood Pharmaceuticals Inc. published this content on May 07, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 07, 2025 at 11:12 UTC.