Tom Graney
Analyst · Morgan Stanley. Your line is now open
Thanks, Peter, and good afternoon, everyone. As Meredith mentioned, during today’s call, I’ll concentrate on financial highlights for our fourth quarter and full year 2016 results as well as provide 2017 financial guidance. Please refer to our press release for the detailed financial information. We recorded $87.4 million of collaborative arrangements revenue on our P&L for the fourth quarter of 2016, up 64% year-over-year and $273.9 million for the full year 2016, an increase of 83% year-over-year. 2016 revenue primarily came from our LINZESS collaboration with Allergan as well as 39 million in milestones from Astellas related to the development and approval of linaclotide for the treatment of adults with IBS-C in Japan. ZURAMPIC net sales are recorded as patients fill prescriptions, which is common for first independently launched product. Net sales in 2016 were approximately $100,000. In the category where there has been little innovation for over 30 years, we expect the slow uptake for the first 12 months and sales to be nominal as we focus on market development including physician education and experience as well as work to secure payer access. We believe the ZURAMPIC is a clear advancement in care and DUZALLO, if approved, should accelerate growth in this category by providing a simple solution to get more uncontrolled gout patients to goal. [Ph] Moving to Ironwood’s operating expenses, for the fourth quarter of 2016, total operating expenses were $93.8 million including $38.4 million in R&D and $55.2 million in SG&A. The spend level in the fourth quarter reflects investments behind the launch of ZURAMPIC, as well as the advancement of our pipeline. For the full year 2016, total operating expenses were $325.8 million including $139.5 million in R&D and $173.3 million in SG&A ,both within our 2016 guided ranges. Turning to our non-GAAP disclosures, remember that we exclude three non-cash adjustments, the mark-to-market adjustment related to the convertible note hedges and warrants; the amortization of acquired intangible assets; and the change in fair value of contingent consideration associated with our licensing agreement with AstraZeneca for lesinurad. GAAP net loss for the fourth quarter of 2016 was $13.5 million or $0.09 per share and non-GAAP net loss was $17.7 million or $0.12 per share. GAAP net loss for the full year 2016 was $81.7 million or $0.56 per share and non-GAAP net loss was $79 million or $0.55 per share. LINZESS continues to reinforce its position as the U.S. branded market leader in IBS-C and CIC with two indications, three approved doses and broad payer access as well as high levels of physician and patient satisfaction. Since launch, nearly 7 million LINZESS prescriptions have been filled by nearly 1.5 million patients. In the fourth quarter and full year 2016, 728,000 and 2.7 million prescriptions were filled, a 24% and 27% increase year-over-year respectively. This translates to total LINZESS net sales for the fourth quarter 2016 of $173.6 million, a 34% increase compared to the fourth quarter of 2015 and $625.6 million for the full year 2016, a 38% increase compared to the full year 2015. As a reminder, we record Allergan’s payment to Ironwood related to the brand as collaboration revenue each quarter. Strong LINZESS volume growth and continued expansion of LINZESS commercial margin drives greater contribution to Ironwood’s top-line. Commercial costs and expenses were $67.4 million for the fourth quarter which included $4.1 million in cost of goods sold and $63.3 million in LINZESS sales and marketing expenses. For the full year 2016, commercial expenses were $265.2 million, which included $15 million in cost of goods sold and $250.2 million in sales and marketing expenses. LINZESS brand collaboration in the U.S. generated $106.2 million in total net profit, a 61% commercial margin for the fourth quarter and $360.3 million in total net profit, a 58% commercial margin for full year 2016. We ended 2016 with $305 million in total cash and investment. Cash used in operations was $19 million for the fourth quarter compared to $19 million in the year ago period. For the full year 2016, cash used in operations was $25 million compared to $107 million in 2015 with 2016 benefitting from $30 million in milestone payments received from Astellas. Strong revenue growth and financial discipline contributed to lower cash used for operations in 2016. As Peter mentioned, 2017 is an important year for Ironwood with the expected advancement of many exciting value-creating opportunities, as you will see on slide nine. As such, we expect cash used for operations to be higher in 2017, given the full-year of commercial expenses related to the launch of ZURAMPIC and if approved, the launch of DUZALLO into the uncontrolled gout market, as well as the advancement of our pipeline assets including linaclotide CR1, IW-3718 and the sGC program. With that said, we continue to expect to cross over to cash flow positive during 2018. Specifically for 2017 financial guidance, we will provide the following: R&D expenses of $145 million to $160 million and SG&A expenses of $235 million to $250 million; total 2017 marketing and sales expenses for LINZESS to be in the range of $250 million to $280 million; net interest expense to be approximately $40 million in connection with our 8.375% notes on which we will begin paying quarterly interest in June 2017 and our 2.25% convertible debt; finally, cash used from operations to be less than $100 million. In summary, we are on track to build a top performing commercial biotech with an expected greater than 25% revenue CAGR between 2016 and 2020, and continued margin expansion. This is driven by expected growth from our two marketed products and innovation that we expect to deliver two commercial launches and at least four mid-stage data readouts in 2017. With that, I’ll hand it back to Andrew to begin the Q&A portion of the call with a reminder that we are hosting an R&D Day in a couple of weeks.