Nabil Shabshab
Analyst · JPMorgan. Please go ahead
Thanks, Jason. Good afternoon and thank you for joining our fourth quarter 2021 conference call. We have made steady progress on the execution of our strategy to expand and effectively increase our sales footprint, while driving the productivity of our commercial operations. We also continue to make progress in mitigating the supply chain challenges in order to meet the market demand and we are investing in R&D and clinical, while strengthening other critical capabilities in support of short-term growth, while setting us up for long-term sustainable and year-over growth in profitability. A few months back, we announced an important new partnership with Ashfield, our contract sales organization to effectively advance our prescriber growth strategy. And we have made significant progress ahead of plan in terms of training and deploying the additional sales representatives and enhancing the operating model. In addition to enhancing our overall commercial excellence, we successfully executed the price increase in September 2021 that primarily offset the cost of inflation associated with the industry-wide limited semiconductor chip availability. Turning to the fourth quarter results, we saw total revenue growth of 3.3% from the fourth quarter of 2020, primarily driven by improved average selling prices, sustained demand and the reduced impact of the COVID-19 pandemic and related Public Health Emergency or PHE versus the comparative period in the prior year which was partially offset by supply chain constraints, that primarily limited sales in our domestic business-to-business channel. This was in line with the midpoint of our preliminary un-audited revenue estimates provided on the January 10th 2022 and the results for each revenue channel reported were in line with those estimates as well. With ongoing supply chain constraints and while attempting to fulfill critical orders for our domestic business-to-business partners we intentionally focus our available capacity on supplying our direct-to-consumer and rental channels and our international business-to-business sales channel in an effort to optimize revenue and margins. Additionally, in anticipation of the temporary suspension of manufacturing operations effective January 1st 2022, we had reserved a portion of our supply produced in December 2021 to partially meet the demand primarily for our direct-to-consumer sales and rental customers we expected in the first quarter of 2022 until the time we had restarted production. Before we go through the fourth quarter financial results in more detail, I would like to provide an update on the two items we reported in the January 10th press release relating to preliminary revenue results, for fourth quarter and full year 2021. With respect to the impact from supply chain disruptions associated with the semiconductor chips used on the printed circuit board and batteries of our portable oxygen concentrators, we are seeing continued pressure on supply with some early signs of improvement in the regular supply channel for these chips. We are working closely with our regular semiconductor suppliers to firm up their overall commitment and smooth out delivery schedule for the orders they had initially confirmed for 2022. Despite early promising signs, the semiconductor shortages linger and likely will continue to limit our ability to fully meet demand in 2022. We reported in the fourth quarter of 2021, prerelease announcement that we were temporarily suspending manufacturing operations due to the semiconductor shortage related to the commitments from various brokers on the open semiconductor market. The late cancellation of committed but outstanding semiconductor orders resulted in a decision to temporarily suspend operations beginning January 3rd 2022. As expected, that suspension was a brief one and we have now restarted our production at our Texas and California facilities and at Foxconn our contract manufacturer in the Czech Republic, between February 7 and 9 2022, ahead of the plan we laid out on January 10, 2022 and we are back at lower production levels. We are continuing to work across the semiconductor suppliers of our OEMs and leveraging to the extent possible, the open market channel to purchase the necessary semiconductor chips. We additionally are completing the redesign of the motherboards on our Inogen One G5 POC to utilize alternative chipsets that currently have a higher level of availability which we expect to begin using in production starting in the second quarter of 2022. With the motherboard redesign, there will be no material impact on the functionality, performance, patient user interface or patient experience, but we expect greater optionality in sourcing semiconductors moving forward. The cost for the chip -- sourced from the open market has trended higher in the fourth quarter of 2021 versus the third quarter of 2021 as a result of high demand and constrained supply. This resulted in inflated costs related to the acquisition of semiconductor chips that negatively impacted our cost of goods sold in the fourth quarter of 2021. We expect the increased cost of chips to have an increased impact on our material cost in 2022 based on purchases already made to secure supply. We also expect such impact will increase as the regular supply chain's ability to catch-up to demand further regresses and the alternate chips that our entry design motherboards start to witness similar shortages due to the heightened demand. The higher semiconductor costs incurred in the fourth quarter of 2021 as a result of sourcing on the open market have also increased our prepaid expenses and other current assets and inventory given that most of these components were not yet in finished goods that were sold during that period. We still believe based on industry feedback and our evaluation that the supply shortages are likely to continue through the second half of 2022 despite some expected improvements. As part of our strategy to minimize supply disruptions and meet a higher portion of the expected 2022 demand, we decided to forward buy a portion of our semiconductor requirements for 2022 opportunistically during the second half of 2021. As a result, we expect the increased cost of goods sold per unit of 2022 to be higher than the cost increase seen in the fourth quarter of 2021, especially given that we will continue to source part of our semiconductor requirements during the first half of 2022 and possibly into the second half of 2022 from the open market channel. While the supply chain situation remains fluid, we are pleased with the motherboard redesign for our Inogen One G5 POC and are aggressively continuing to pursue efforts to get firmer commitments from the regular supply channel, while simultaneously canvassing the open market for additional quantities. Again our execution around the price increase we took back in September 2021 has allowed us to cover most of the cost inflation due to the chip shortages. As mentioned in our pre-announcement on January 10 2022, current Inogen products are commercialized in the European Union under the Medical Device Director certificates and ours is expected to expire on May 18, 2022. We are preparing the filing for the MDR submissions for certification under the EU Medical Device Regulation in the earlier part of 2022 for both existing and new and improved systems and expect the MDR certificates to be issued during the third quarter of 2022. We have verified our ability to meet most of the demand in terms of existing orders through our shipments up to May 18, 2022 MDD certificate expiry. Additionally we are in the process of applying for select EU country level derogations or exemptions as an additional mitigation measure. We are also working towards securing the necessary certification for Great Britain and Switzerland where the EU MDR is not directly applicable, allowing for continued operations in those two territories independent of the time frame for certification under the EU MDR. I would like to reiterate that the anticipated GAAP and EU marketing is unrelated to product safety or performance and will not impact US commercialization. Based on our latest discussions with the notified bodies, we expect the EU MDR dossier for our improved products to be reviewed and potentially cleared in time for long-term operations in the EU. With that, I will now provide details for our fourth quarter 2021 revenue by channel. For the fourth quarter of 2021, we generated total revenue of $76.4 million compared to $74 million in the fourth quarter of 2020, which represents an increase of 3.3% over the comparative period. Domestic business-to-business sales in the fourth quarter of 2021 decreased 57.6% to $10.3 million compared to $24.2 million in the fourth quarter of 2020, primarily due to supply chain constraints that limited product availability in this channel. International business-to-business sales in the fourth quarter of 2021 increased by 47.6% or 50% on a constant currency basis to $20.1 million compared to $13.6 million in the fourth quarter of 2020. The increase was primarily driven by increased ambulation of patients in Europe and improving operational capacity of certain European respiratory assessment centers closer to normal level as improving COVID-19 vaccination rates has enabled patients to return to normalized activity levels and seek treatments, partially offset by supply chain constraints that limited product availability in this channel. Domestic direct-to-consumer sales increased 23.3% to $33 million in the fourth quarter of 2021 from $26.8 million in the fourth quarter of 2020, primarily driven by increased average selling prices. Inside sales represented productivity increased in the quarter despite lower average inside sales representative headcount, which was down approximately 3% from the comparative period in the prior year. We are continuing to optimize our inside sales representative team by increasing our focus on enhanced sales management disciplines and utilizing data driven and insights led sales techniques aimed at improving the productivity of our inside sales force. We are pleased with the performance of our inside sales team in the fourth quarter, as we saw improved direct-to-consumer sales productivity to representatives and increased average revenue per order versus the fourth quarter of 2020, including the price increase effective September 1, 2021. Rental revenue in the fourth quarter of 2021 increased 39.4% to $13 million from $9.4 million in the same period in 2020 primarily due to increased patient for service higher Medicare reimbursement rates and higher billable patients as a percent of total patient home service. As of December 31, 2021 we had approximately 42,900 patients on service, which was up 6.2% sequentially compared to September 30, 2021 and up 33.2% compared to December 31, 2020. The increase in patients on service was primarily driven by greater utilization of patient leads for rental opportunities and physician-facing initiatives to increase prescriber awareness by our sales force as well as the relaxed Medicare criteria for oxygen therapy reimbursement due to the COVID-19 PHE. Despite the supply chain challenges being worked through, we remain cautiously optimistic about the direct-to-consumer sales and rental channels while we continue to assess the potential impact including changing COPD diagnostic rates and other variables as a result of the COVID-19 in the US and other major markets where we operate. Moving to the strategic initiatives focused on increasing our prescriber sales organization. Our total physician sales representative headcount was 35 as of December 31, 2021 compared to 24 as of December 31, 2020 an increase of approximately 46%. However, in light of the collaboration with our contracted organization Ashfield as of January 2022, our prescriber-facing sales organization was at 47 sales reps in place and 10 sales reps with accepted offers that will be in the field early March 2022 well ahead of the timing we have communicated when we announced this agreement. To support the combined 57 physician-facing sales reps, we have evolved our operating model by adding 12 Ashfield concierge service reps that will be assuming administrative responsibilities, which we believe will increase the selling time of the sales reps by about 60% according to our internal early estimates while improving the customer and patient experience. We expect the new strategy and action plan will significantly improve our coverage of the highest proprietary prescribers with adequate core frequency while driving sales productivity through proprietary prescriber insights and analytics for the first time with Inogen. The enhanced sales tools and techniques, as well as the concierge service model, will benefit the combined sales force including Inogen and Ashfield representatives and we expect will increase our coverage of the portable oxygen patients that are diagnosed and prescribed in the prescriber channel from 40% to approximately 65%. Regarding reimbursement rates, we continue to see increases in Medicare rates for oxygen therapy with Medicare reimbursement rates increasing approximately 5% effective January 1, 2022 and due to the annual inflation adjustment. The 2% Medicare sequester benefit that has been in place since May 2020 due to the COVID-19 PHE was set to expire December 31, 2021 but has now been extended until March 31, 2022. The sequester then resumes with a 1% reduction to rates from April 1, 2022 until June 30, 2022 with the full 2% Medicare sequester resuming July 1, 2022 and continuing through September 30, 2030. As we look ahead, despite some near-term challenges the underlying demand for our offerings is strong and we are committed to increasing the POC market penetration and improving patient access. In the meantime, we are committed to working through the ongoing supply challenges and mitigating most of the material cost inflation focusing on commercial excellence and driving our operational efficiency. We will continue to invest in our infrastructure and capability build, clinical evidence, innovation and new product development as well as commercial capabilities to strengthen and advance our market leadership position in portable oxygen therapy. We believe that these focus areas and investments will contribute to our aspirations of long-term sustainable and profitable growth and value creation. With that I will now turn the call over to our Interim CFO Mike Sergesketter. Mike?