John Bostjancic
Analyst · Piper Sandler
Thanks, Keith, and good afternoon, everyone. As Keith noted earlier, revenue for the second quarter of 2021 totaled $47.5 million, a 66% increase compared to the second quarter of 2020 and a 13% sequential increase compared to the first quarter of 2021. U.S. revenue totaled $42.6 million and included $600,000 of 7D Surgical capital sales revenue, a 64% increase compared to the second quarter of 2020 and a 14% sequential increase compared to the first quarter of 2021. U.S. spinal implant and Enabling Technologies revenue in the second quarter of 2021 totaled $21.4 million, a 62% increase compared to the second quarter of 2020 and a 16% sequential increase compared to the first quarter of 2021. That growth was led by new and recently launched products, predominantly those that were launched alpha or fully in 2020 and the first half of 2021. The rapid clinical adoption of our most recently launched products is a very encouraging sign for the growth that they can drive in the second half of 2021, particularly in Q4. We continue to experience low to mid-single-digit declines in average selling prices common in the spine industry. U.S. orthobiologics revenue in the second quarter of 2021 totaled $21.2 million, a 67% increase compared to the second quarter of 2020 and an 11% sequential increase compared to the first quarter of 2021. Those increases were once again driven by growth in the OsteoStrand Plus product. International revenue in the second quarter of 2021 totaled $4.9 million, an 81% increase compared to the second quarter of 2020 and a 9% sequential increase compared to the first quarter of 2021. In our press release, we also provide comparisons of our revenue results for the second quarter of 2019 as the impacts of COVID-19 on our business in the second quarter of 2020 make a comparison to the second quarter of 2019 a useful supplemental metric to measure growth. COVID-19 had a larger adverse impact on our U.S. orthobiologics business in the second quarter of 2020 compared to the spinal implant business, which resulted in atypical relative growth rates, with orthobiologics growing faster than spinal implants by that measure. The growth rates compared to the second quarter of 2019 are more in line with the typical relative growth rates, with spinal implants growing meaningfully faster than orthobiologics. GAAP gross margin for the second quarter of 2021 was 63.2% compared to 59.2% for the second quarter of 2020. The increase in gross margin was primarily due to idle plant costs recorded in the second quarter of 2020 associated with the nearly 2 months' shutdown of orthobiologics manufacturing operations at our Irvine facility. The year-over-year gross margin benefit from increased sales in the U.S. of our high-margin spinal implant products was mostly offset by 2 factors: higher kitting and logistics costs incurred in preparation for the full commercial launches of the spinal implant systems expected in the second half of 2021 that Keith mentioned earlier and from $300,000 of technology-related intangible asset amortization associated with the acquisition of 7D Surgical. Adjusted gross margin, which excludes technology-related intangible asset amortization and idle manufacturing plant costs was 64.5% for the second quarter of 2021 compared to 63.5% for the second quarter of 2020. The anticipated shift to more full commercial launches of spinal implant systems in 2021 is expected to generate higher excess and obsolete inventory charges relative to prior years from the substantial investment in outsized implant inventory required with those set builds. However, that impact notwithstanding, we believe that we can continue to expand adjusted gross margins by 100 to 150 basis points per year over the next 2 to 3 years. Operating expenses for the second quarter of 2021 totaled $41.1 million, a $10.5 million increase compared to $30.6 million for the second quarter of 2020 and included $1.6 million of 7D Surgical operating expenses. The increase in operating expenses was driven primarily by $8.4 million in higher selling and marketing expenses, the majority of which relates to selling commissions; $1.1 million in higher general and administrative expenses, which included more than $500,000 in legal and other professional fees incurred in connection with the 7D Surgical acquisition and integration and $900,000 in higher research and development expenses. We reported a $6.2 million nonoperating gain and other income net in the second quarter of 2021 in connection with the forgiveness by the SBA of the total amount outstanding of our Paycheck Protection Program loan. Net loss for the second quarter of 2021 was $5.2 million compared to a net loss of $13.7 million for the second quarter of 2020. Adjusted earnings before interest, taxes, depreciation and amortization for the second quarter of 2021 improved by $4.3 million to a loss of $3.5 million, compared to a loss of $7.8 million for the second quarter of 2020. Adjusted gross margin and adjusted EBITDA loss are non-GAAP financial measures that we believe provide valuable information on our operating results that facilitates comparability of our core operating performance from period to period and against other companies in our industry. A reconciliation of GAAP gross margin to adjusted gross margin and of GAAP net loss to adjusted EBITDA loss was presented in the financial tables of the press release we issued this afternoon. Cash and cash equivalents at June 30, 2021, totaled $120.7 million, and we had no amounts outstanding under our credit facility. We received $94.5 million of net proceeds in April 2021 from an underwritten public offering of 5.2 million shares of our common stock. We paid $28.3 million in cash consideration in May 2021 in connection with the acquisition of 7D Surgical and, in April 2021, repaid the entire $20 million of outstanding borrowings under our credit facility. Our free cash flow burn, which includes operating cash flows and purchases of property and equipment, was $14.7 million for the second quarter of 2021, a $3.2 million increase compared to $11.5 million for the second quarter of 2020 and was $21.4 million for the first half of 2021, a $5 million increase compared to $16.4 million for the first half of 2020. Those increases were primarily attributable to higher investments in spinal implant set build and instrument capital expenditures needed to support a greater number of full commercial launches in 2021. Turning to our financial outlook for 2021. We remain focused on expanding our gross margin and continuing to reduce cash-based G&A expenses as a percentage of revenue. However, we plan to continue to redeploy any operating leverage towards the sales, marketing and R&D initiatives and inventory and spinal implant set build capital expenditures that are critical to driving the sustained accelerated revenue growth implied by our 2021 revenue guidance. As Keith noted earlier, we now expect full year 2021 revenue to be in the range of $201 million to $205 million, reflecting growth of 30% to 33% compared to full year 2020 revenue and 26% to 29% over full year 2019 revenue. In addition to expressing our confidence via a $1 million increase in the bottom end of the revenue guidance range, we also want to provide more color on our expectations for quarterly revenue progression for the second half of 2021. Based on a number of factors, including surgeon feedback regarding taking vacation time this summer, the timing of the North American Spine Society meeting in late September and the rescheduling due to COVID-19 of other large industry trade shows into the third quarter and a greater percentage of 7D placements expected under an earnout arrangement than originally anticipated because of the new compensation model we introduced for the 7D sales team, we are now expecting more seasonality than we did earlier in the year. For Q3 2021, we now anticipate 16% to 18% year-over-year growth and, for Q4 2021, expect 33% to 39% year-over-year growth. That represents a roughly 5% to 8% sequential increase for the typically seasonally weak third quarter compared to the second quarter of 2021, which is typically one of the strongest quarters of the year. While the near-term impact of a higher-than-expected 7D earnout placement assumption has the effect of lowering 7D's anticipated contribution to third quarter 2021 revenue, it provides a much greater upside benefit to revenue and contribution margins for the fourth quarter of 2021 and for the next 2 to 3 years through the longer-term contractual relationship contemplated by the earnout commitments from those accounts. We expect to further reduce our adjusted EBITDA loss in 2021 compared to last year, including the anticipated dilutive impact of 7D Surgical on our P&L this year. We expect our free cash flow burn for 2021 to be between $46 million and $49 million. That increase versus 2020 is due in part to anticipated adjusted EBITDA dilution from 7D Surgical in 2021 but more significantly from the more than 60% planned increase to nearly $40 million in spinal implant inventory instrument and set build CapEx investments Keith mentioned earlier to support the many full commercial launches slated for 2021. With respect to the 7D Surgical acquisition, certain 7D shareholders elected to receive exchangeable shares at the closing, which allows them to defer certain taxable events until they tender those exchangeable shares for shares of SeaSpine common stock. As a result of the roughly 4.3 million shares of SeaSpine common stock in total that will ultimately be issued to 7D shareholders, a total of 1.3 million exchangeable shares that were actually issued will not be reflected in the denominator for loss per share calculations until the 7D shareholders tender those exchangeable shares because of their anti-dilutive effect. Those exchangeable shares, which will be treated consistent with common stock equivalents, like RSUs and stock options, in the loss per share denominator, must be tendered within 5 years of their issuance. At this time, we can't predict the timing that the 7D shareholders who elected to receive those 1.3 million exchangeable shares will tender them for shares of SeaSpine common stock, and that will likely be a decision each 7D shareholder makes based on their own personal tax planning. With more than $120 million in cash and cash equivalents on hand, plus the additional liquidity that we can access through our $30 million credit facility, which we extended for at least 1 year to July 2022 and for which we can elect to expand to $40 million, we have never been better capitalized to continue to invest confidently and aggressively for growth. At this point, I'd like to turn the call over to Keith for closing comments.