Full Press Release Details
Ironwood Pharmaceuticals Reports Third
Quarter 2019 Results; Raises Full Year 2019 Guidance -
Total revenue of $131 million, driven primarily by LINZESS (linaclotide) U.S. collaboration revenue of $85 million and ex-U.S.
license and milestone revenue of $42 million -
$21 million in GAAP net income from continuing operations; $76 million in adjusted EBITDA from continuing operations -
LINZESS prescription demand continued to grow, achieving all-time highs during the period -
Phase II top-line data now expected mid-2020 vs 2H 2020 due to faster enrollment -
Mass., October 31, 2019 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today
provided an update on its third quarter 2019 results and recent business performance. Ironwood also announced that it is increasing
its full year 2019 total revenue and adjusted EBITDA from continuing operations guidance.
"We demonstrated solid execution during the third quarter
highlighted by further growth in LINZESS prescription demand, the continued advancement of our late-stage pipeline, and strong
operational performance," said Mark Mallon, chief executive officer of Ironwood. "LINZESS prescription demand grew
15% year-over-year - maintaining strong double-digit growth through the summer months. We also simplified our business by
successfully amending our linaclotide ex-U.S. partnerships in China and Japan, establishing a new U.S. commercial partnership with
Alnylam for givosiran in AHP, and restructuring our debt - all while continuing to deliver profits. As a result of this strong
performance, we look forward to building on this momentum as we strive to deliver value for all Ironwood stakeholders."
Third Quarter 2019 Financial Highlights1
(in thousands, except for per share amounts)
| 3Q 2019 | 3Q 2018 | |||||||
| Total revenues | $ | 131,167 | $ | 65,686 | ||||
| Total costs and expenses | 65,280 | 212,257 | ||||||
| GAAP net income (loss) from continuing operations | 20,648 | (151,823 | ) | |||||
| GAAP net income (loss) | 20,648 | (174,351 | ) | |||||
| GAAP net income (loss) per share | 0.13 | (1.14 | ) | |||||
| Adjusted EBITDA from continuing operations | 75,658 | (15,428 | ) | |||||
| Non-GAAP net income (loss) | 62,921 | (41,843 | ) | |||||
| Non-GAAP net income (loss) per share | 0.40 | (0.27 | ) |
Third Quarter 2019 Corporate Highlights
| U.S. LINZESS Full Brand Collaboration 1 (in thousands, except for percentages) | Three Months Ended September 30, | |||||||
| 2019 | 2018 | |||||||
| LINZESS U.S. net sales 2 | $ | 214,743 | $ | 204,815 | ||||
| Allergan & Ironwood commercial costs and expenses | 63,870 | 62,798 | ||||||
| Commercial margin 2 | 70 | % | 69 | % | ||||
| Allergan & Ironwood R&D Expenses | 16,436 | 16,547 | ||||||
| Total net profit on sales of LINZESS 2 | 134,437 | 125,470 | ||||||
| Full brand margin 2 | 63 | % | 61 | % |
Global Collaborations and U.S. Promotional Partnerships
Additional Business Updates
Third Quarter Financial Results
Ironwood 2019 Financial Guidance
Ironwood revised its 2019 financial guidance and
| Original 2019 Guidance | Revised 2019 Guidance 1 | |||
| Total revenue | $370 - $390 million | $410 - $420 million | ||
| Net interest expense | ~$35 million | Unchanged | ||
| Separation expenses 2 | $30 - $40 million | ~$30 million | ||
| Restructuring expenses 3 | ~$3 - $4 million | ~$4 million | ||
| Adjusted EBITDA from continuing operations 4 | >$65 million | >$130 million | ||
| LINZESS net sales growth | Low-to-mid single digit % increase | Mid-single digit % increase |
1 Revised 2019 guidance for total revenue
and Adjusted EBITDA from continuing operations reflects approximately $42.4 million in license and milestone payments related to
the amended ex-U.S. agreements with Astellas and AstraZeneca that were recognized in the third quarter of 2019.
2 Separation expenses were $6.7 million
in the third quarter of 2019.
3 Restructuring expenses were largely
incurred during the first quarter of 2019 in connection with the reduction in workforce commenced in February 2019. Total restructuring
adjustments in the third quarter of 2019 were $0.2 million.
4 Adjusted EBITDA from continuing operations
is calculated by subtracting net interest expense, taxes, depreciation, amortization, fair value of remeasurement of contingent
consideration, mark-to-market adjustments on derivatives related to Ironwood's 2022 Convertible Notes, impairment of intangibles,
restructuring expenses, separation expenses, and loss of extinguishment of debt from GAAP net income (loss) from continuing operations.
In the second quarter of 2019, Ironwood began reporting in its financial statements GAAP net income (loss) from continuing operations
which excludes discontinued operations related to Cyclerion.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income (loss) and non-GAAP net
income (loss) per share to exclude the impact of net gains and losses on derivatives related to our 2022 Convertible Notes that
are required to be marked-to-market, the amortization of acquired intangible assets, the fair value remeasurement of contingent
consideration associated with Ironwood's U.S. license agreement with AstraZeneca for the exclusive rights to all
products containing lesinurad, and the impairment of intangible assets associated with Ironwood's subsequent notice of termination
of the lesinurad license agreement, if any. Ironwood also excludes restructuring, separation-related expenses and loss on extinguishment
of debt from non-GAAP net income (loss). These adjustments are reflected in the non-GAAP net income (loss) in the third quarter
of 2019 and 2018 presented in this press release. Non-GAAP adjustments are further detailed below:
Ironwood also presents adjusted EBITDA from continuing operations,
a non-GAAP measure. Adjusted EBITDA from continuing operations is calculated by subtracting net interest expense, taxes, depreciation,
amortization, fair value of remeasurement of contingent consideration, mark-to-market adjustments on derivatives related to Ironwood's
2022 Convertible Notes, restructuring expenses, separation expenses and loss on extinguishment of debt from GAAP net income (loss)
from continuing operations. The adjustments are made on a similar basis as described above related to non-GAAP net income (loss),
Management believes this non-GAAP information is useful for
investors, taken in conjunction with Ironwood's GAAP financial statements, because it provides greater transparency and period-over-period
comparability with respect to Ironwood's operating performance. These measures are also used by management to assess the
performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for
or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures
are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of non-GAAP net income
(loss) and non-GAAP net income (loss) per share to GAAP net income (loss) and GAAP net income (loss) per share, respectively, and
for a reconciliation of adjusted EBITDA from continuing operations to net income (loss) from continuing operations on a GAAP basis,
please refer to the tables at the end of this press release. Ironwood does not provide guidance on GAAP net income (loss) from
continuing operations or a reconciliation of expected adjusted EBITDA from continuing operations to expected GAAP net income (loss)
from continuing operations because, without unreasonable efforts, it is unable to predict with reasonable certainty the non-GAAP
adjustments used to calculate adjusted EBITDA from continuing operations including, without limitation, the mark-to-market adjustments
on the derivatives related to its 2022 Convertible Notes. These adjustments are uncertain, depend on various factors and could
have a material impact on GAAP net income (loss) from continuing operations for the guidance period.
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m.
Eastern Time on Thursday, October 31, 2019 to discuss its third quarter 2019 results and recent business activities. Individuals
interested in participating in the call should dial (866) 393-4306 (U.S. and Canada) or (734) 385-2616 (international) using conference
ID number 1683099. To access the webcast, please visit the Investors section of Ironwood's website at www.ironwoodpharma.com
at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The
call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time, on October 31, 2019 running
through 11:59 p.m. Eastern Time on November 14, 2019. To listen to the replay, dial (800) 585-8367 (U.S. and Canada) or (416) 621-4642
(international) using conference ID number 1683099. The archived webcast will be available on Ironwood's website for 14 days
beginning approximately one hour after the call has completed.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare
company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and
are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation
(IBS-C) or chronic idiopathic constipation (CIC).
We are also advancing two late-stage, first-in-category GI product
candidates: IW-3718 is a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of
persistent gastroesophageal reflux disease, and MD-7246 is a delayed-release formulation of linaclotide that is being evaluated
as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated certain GI diseases.
Ironwood was founded in 1998 and is headquartered in Boston,
Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted in both these locations.
About LINZESS (linaclotide)
prescribed brand for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic
constipation (CIC), based on IQVIA data.
LINZESS is a once-daily
capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools,
hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145
mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability.
LINZESS should be taken at least 30 minutes before the first meal of the day.