10/28/2021

speaker
Katie
Conference Call Coordinator

Hello and welcome to the Internet Third Quarter 2021 Financial Results. My name is Katie and I'll be coordinating your call today. If you'd like to ask a question during the presentation, you may do so by pressing star 1 on your telephone keypad. I'll now hand over to your host, Eleanor Brassiere, to begin. Please go ahead.

speaker
Eleanor Brassiere
Host

Thank you, Katie. Good morning and welcome to today's conference call to discuss our Third Quarter 2021 Financial Results and provide a business update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations. Such statements represent our judgment as of today and may involve risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward-looking statements. please refer to our filings with the Securities and Exchange Commission, which are available through the SEC's website at www.sec.gov or from our website for information concerning the risk factors that could affect the company. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining me on today's call are members of the Innsmouth Executive Management Team, including Will Lewis, Chair and Chief Executive Officer, Dr. Martina Flammer, Chief Medical Officer, Roger Asset, Chief Operating Officer, and Sarah Bonstein, Chief Financial Officer. Let me now turn the call over to Will Lewis for prepared remarks. Upon completion of those remarks, we will open the call up for your questions.

speaker
Will Lewis
Chair and Chief Executive Officer

Thank you, Eleanor. Good morning, everyone. We are pleased to share our third quarter results with you today. I want to start my comments by saying that Insumet has seen remarkable growth and accomplishment during the time of the pandemic. This growth has ushered in a new framework for Insumet. We are currently advancing four strategic pillars. The first is Aircase, our marketed product for the treatment of refractory MTM, which is now approved in three major territories around the world. the U.S., Europe, and Japan. Notably, the Japan launch kicked off in July. We are very pleased with the progress to date, and we believe there is tremendous opportunity to help patients in this region. When we think about the overlap of NTM and bronchiectasis call points, our commercial operations in the U.S., Europe, and Japan are preparing us well in advance for the potential launch of Brenzocantib, should that product candidate achieve regulatory approval. Aracase is also being explored in a frontline clinical trial program in patients with NPM lung disease, which will allow us to take advantage of our commercial footprint. The second pillar is brenzocatib, our DPP-1 inhibitor currently in the Phase III Aspen trial for the treatment of bronchiectasis. In addition to Aspen, we continue to work toward advancing brenzocatib in a Phase II trial in cystic fibrosis. Beyond these two initial indications, our team has identified additional opportunities where Brenzocat may have utility by way of the DPP-1 inhibition pathway. And we look forward to having more to say about the progress we are making in these potential additional indications early next year. Our third pillar is TPIP, a tryprosinol prodrug, which we are advancing through clinical development for the potential treatment of pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD. Finally, our efforts in translational medicine. This pillar is focused on identifying the next set of critical candidates to enter our pipeline, with a sharp focus on disruptive technologies in the rare disease landscape that could yield a high degree of impact for underserved patients. We see these investments now as a key to developing a future pipeline that we hope will quickly follow behind the anticipated success of the first three pillars. We believe that within each of these pillars is enormous potential that could catalyze the next phase of growth for Insmed, We expect to share more on each of these pillars early next year. Finally, let me briefly address the ongoing pandemic. Throughout the second quarter, we saw promising signs of a return to growth. Early in the third quarter, these signs of growth were muted by the impact of the Delta variant around the world. We continue to see the temporary negative impact of COVID surges when they occur, but believe we have the means to return to growth once they have abated. even in the endemic phase of this virus. One consequence of this persistence of the virus is that we have made the decision to require all U.S. employees of Insmed to get vaccinated starting in mid-December. No doubt this will result in some employees choosing to leave their employment with Insmed. While this is regrettable, we believe this requirement is the best way to protect physicians, patients, caregivers, and employees, and to play our part to help bring this pandemic under control. We are at an exciting and pivotal moment in Insmed's growth trajectory. The next 12 months will be an extremely important execution period as Insmed continues to perform across our commercial operations, clinical trial work, and research efforts. I believe we have the patient focus, collective drive, infrastructure, and strong capital position to help us reach our goals. With that, I'll turn the call over to Sarah to walk through our financial results.

Disclaimer

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