UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Result of Operations and Financial Condition.
On January 9, 2023, Outset Medical, Inc. (the “Company”) issued a press release announcing, among other items, expected revenue for the fourth quarter and fiscal year ended December 31, 2022, as well as guidance for 2023 revenue and non-GAAP gross margin. A copy of the Company’s press release is furnished herewith as Exhibit 99.1.
Certain financial information contained in Exhibit 99.1 is preliminary, unaudited and subject to change or adjustment in connection with the completion of the Company’s quarter and year-end closing processes and the preparation of its audited financial statements for the fiscal quarter and year ended December 31, 2022, which will be contained in the Company’s related Annual Report on Form 10-K.
Item 7.01 Regulation FD Disclosure
On January 9, 2023, the Company posted a presentation on the investor section of its website at investors.outsetmedical.com to be used by the Company in connection with its participation in the J.P. Morgan Healthcare Conference. A copy of the presentation is furnished herewith as Exhibit 99.2.
The information contained in Items 2.02 and 7.01 (including Exhibits 99.1 and 99.2 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward-Looking Statements
This report and the exhibit attached hereto contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the Company’s preliminary results of operations, including fourth quarter and full year 2022 revenue and 2022 non-GAAP gross margin, statements about possible or assumed future results of operations and financial position, including expectations regarding projected revenues and non-GAAP gross margin; statements regarding the Company’s overall business strategy, plans and objectives of management; the Company’s expectations regarding the market sizes and growth potential for Tablo and the total addressable market opportunities for Tablo, the Company's planned expansion within the home hemodialysis market and expected drivers of home dialysis adoption, as well as the Company’s expectations regarding the impact of macroeconomic factors on the Company, its customers and suppliers Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission, including its latest annual and quarterly reports. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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99.1 |
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99.2 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Outset Medical, Inc.
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Date: January 9, 2023 |
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By: |
/s/Nabeel Ahmed |
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Nabeel Ahmed |
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Chief Financial Officer |
Exhibit 99.1
Outset Medical Reports Expected Fourth Quarter and Full Year 2022 Revenue, Provides 2023 Revenue and non-GAAP Gross Margin Guidance
San Jose, CA – January 9, 2023 – Outset Medical, Inc. (Nasdaq: OM) (“Outset” or the “Company”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today reported expected revenue for the fourth quarter and fiscal year ended December 31, 2022.
Fourth Quarter and Year End Highlights
“During an important year for Outset, we significantly increased the number of Tablo consoles in hospitals and homes, surpassed 1 million treatments delivered and helped healthcare providers continue to deliver exceptional, lower-cost care in a tight labor market,” said Leslie Trigg, Chair and Chief Executive Officer of Outset. “We also strengthened our foundation by continuing to innovate and extend Tablo’s technological advantage, adding key talent, topping off our balance sheet and exiting the year with momentum, finishing the fourth quarter strong and setting up what we believe will be an even stronger 2023.”
Outset expects 2023 revenue to be between $140 million to $150 million, growing approximately 22% to 30% over expected revenue for 2022. Non-GAAP gross margin is expected to expand to approximately 20% for the full year 2023 and exit the year in the mid-20% range for the fourth quarter of 2023.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements about the Company’s expected results of operations, including fourth quarter and full year 2022 revenue and 2022 non-GAAP gross margin, statements about possible or assumed future results of operations and financial position, including expectations regarding projected revenues and non-GAAP gross margin; statements regarding the Company’s overall business strategy, plans and objectives of management; the Company’s expectations regarding the market sizes and growth potential for Tablo and the total addressable market opportunities for Tablo, as well as the Company’s expectations regarding the impact of macroeconomic factors on the Company, its customers and suppliers. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause actual results or other events to differ materially from those contemplated in this press release can be found in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission, including its latest annual and quarterly reports. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as
of their date and, except to the extent required by law, the Company undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.
Certain financial information contained in this press release is preliminary, unaudited, and subject to change or adjustment in connection with the completion of the Company’s quarter and year-end closing processes and the preparation of its audited financial statements for the fiscal quarter and year ended December 31, 2022, which will be contained in the Company’s related Annual Report on Form 10-K.
About Outset Medical, Inc.
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis. The Tablo® Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone. The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care. Tablo is a registered trademark of Outset Medical, Inc.
Investor Contact
Jim Mazzola
Outset Medical
858-342-8272
jmazzola@outsetmedical.com
Media Contact
Nicole Shannon
Director, Marketing Communications for Outset Medical
nshannon@outsetmedical.com
Outset Medical Investor Presentation January 2023
Forward-looking statements This presentation and the accompanying oral statements contain forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “plan,” anticipate,” “believe,” “estimate,” “predict,” “intend,” “potential,” “would,” “continue,” “ongoing” or the negative of these terms or similar expressions. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends, which affect or may affect our business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. These forward-looking statements include, but are not limited to, statements about the Company’s expected results of operations, including fourth quarter and full year 2022 revenue and 2022 non-GAAP gross margin, statements about our possible or assumed future results of operations and financial position, including expectations regarding projected revenues, and revenue growth rate, gross margin (including non-GAAP gross margin), profitability and outlook, statements regarding our overall business strategy, plans and objectives of management, our expectations regarding the market sizes and growth potential for Tablo and the total addressable market opportunities for Tablo, our planned expansion within the home hemodialysis market and expected drivers of home dialysis adoption, our expectations with respect to anticipated benefits of the TPNIES approval, as well as our expectations regarding the impact of macroeconomic factors on us, our customers and our suppliers. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, which could cause actual results to differ materially from those expressed or implied in these forward-looking statements. These risks and uncertainties include: our future financial performance, including our expectations regarding our revenues, cost of revenues, operating expenses, gross margin and our ability to achieve and maintain future profitability; continued execution of our initiatives designed to reduce the cost of producing and shipping Tablo devices and our ability to achieve projected cost reductions at the levels or within the timeframe we estimate; our ability to attain market acceptance among providers and patients; our ability to manage our growth; our expansion into the home hemodialysis market; our ability to ensure strong product performance and reliability; our relations with third-party suppliers, including contract manufacturers and single source suppliers; our ability to overcome manufacturing disruptions; the impact of COVID-19, natural or man-made disasters, and similar events, on our industry, business and results of operations; our ability to offer high-quality support for Tablo; our expectations of the sizes of the markets for Tablo; our ability to innovate and improve Tablo; our ability to effectively manage privacy, information and data security; concentration of our revenues in a single product and concentration of a large percentage of our revenues from a limited number of customers; our ability to compete effectively; our ability to accurately forecast customer demand and manage our inventory; our ability to ensure the proper training and use of Tablo; and our compliance with FDA and other regulations applicable to our products and business operations; as well as other risks and uncertainties described in the Risk Factors section of our public filings with the SEC, including our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements should be considered in light of these risks and uncertainties, and you should not rely on these forward-looking statements as predictions of future events. These forward- looking statements speak only as of their date and we undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. This presentation and the accompanying oral presentation also contain statistical data, estimates and forecasts that are based on independent industry publications or other publicly available information, as well as other information based on our internal sources. This information involves many assumptions and limitations, and you are cautioned not to give undue weight to such information. We have not independently verified the accuracy or completeness of the information contained in the industry publications and other publicly available information. Accordingly, we make no representations as to the accuracy or completeness of that information nor do we undertake to update such information after the date of this presentation. Certain financial information contained in this presentation is preliminary, unaudited, and subject to change or adjustment in connection with the completion of our quarter and year-end closing processes and the preparation of its audited financial statements for the fiscal quarter and year ended December 31, 2022, which will be contained in our related Annual Report on Form 10-K.
Transforming dialysis from the hospital to the home
Reducing the cost and complexity of dialysis SUMMARY Established footprint in $2.5B U.S. acute care market Growing patient base in $8.9B U.S. home market $11.4B U.S. total addressable market1 1. Company estimates based on data contained in U.S. Renal Data System (USRDS) 2021 Annual Data Report 2022 expected revenue of ~$115M 175% CAGR (2018–2022) Multiple tailwinds driving Tablo adoption
7%2 for 1%2 CURRENT STATE Dialysis is one of the largest, most expensive, least-changed sectors of healthcare $73B1 Annual spending on U.S. ESRD patients $41B1 Paid by Medicare 600,0003 Dialysis patients 90M3 Annual dialysis treatments 2022 2030 30% 1. Company estimates based on data contained in USRDS 2021 Annual Data Report Percentage of entire Medicare budget spent on dialysis for ESRD patients, who comprise 1% of the Medicare population (2019) Company estimates based on data contained in USRDS 2022 Annual Data Report 3
135,000 New ESRD patients diagnosed annually in the U.S. 60% Crash into dialysis Acute USRDS 2021 and 2022 Quarterly and Annual Data Reports CURRENT STATE Dialysis care pathways
60% Crash into dialysis 40% Managed into dialysis Clinic 13% 87% Acute Home USRDS 2022 Annual Data Report CURRENT STATE Dialysis care pathways
CURRENT STATE This is an expensive care delivery model… 60% Crash into dialysis 40% Managed into dialysis Acute Clinic $5,000–$25,000 Average loss by hospital for each inpatient stay for renal failure with dialysis1 $30 billion Annual cost of in-center dialysis treatment in clinics 34%1 30-day hospital readmission rate for hemodialysis patients1 1. Hickson LJ. et al. Nephron. 2018; 139(1): 1–12 2021 Medicare Claims data for MS-DRG 682 and MS-DRG 683 Company estimates based on data contained in USRDS 2022 Annual Data Report; League et al, JAMA Feb. 2022; Lin et al Health Affairs, Aug. 2022
Dialysis is in need of new solutions CURRENT STATE Hospitals lose money on every treatment Staffing challenges constrain optimal patient care and drive up cost Complicated technologies made home hemodialysis impractical for most patients
We see a technology-driven way forward
Tablo® is a first-of-its- kind technology designed to reduce the cost and complexity of dialysis Single device from ICU to home Connected and intelligent Small and mobile
An all-in-one solution that replaces multiple machines and a water treatment room with a single device
One device, multiple markets $2.5B Acute market Hospital & sub-acute based dialysis $8.9B Home market Home hemodialysis & transitional care $11.4B U.S. TAM Company estimates based on data contained in USRDS 2021 Annual Data Report
One device, multiple markets $11.4B U.S. TAM $2.5B Acute market Hospital & sub-acute based dialysis $8.9B Home market Home hemodialysis & transitional care Company estimates based on data contained in USRDS 2021 Annual Data Report
ACUTE CARE Tablo reduces the cost and complexity of acute dialysis TOTAL POTENTIAL COST SAVINGS 50%–80%1 Potential payback period <1 year 1. Company estimates based on data provided by third party health systems Supplies cost reduction Before Tablo With Tablo Existing ICU machines require numerous dialysate bags for each treatment Tablo creates the dialysate on demand, eliminating the cost and complexity of bags Most hospitals incur the additional cost of outsourcing dialysis to a 3rd party provider Enables hospitals to insource and utilize their existing nursing staff to deliver dialysis Labor cost reduction
ACUTE CARE Tablo can deliver significant savings Hospital St. Mark’s Hospital Location Salt Lake City, Utah Beds 300 ICU beds 24 “(We saw) huge cost savings and high ratings on the training experience, treatment setup and starts, and a 96.2% average success rate.” —Kasi Moore, Nurse Manager $450K Annual estimated savings $500 Savings per Tx ~70% Cost reduction per Tx 50% Labor cost reduction
One device, multiple markets $2.5B Acute market Hospital & sub-acute based dialysis $8.9B Home market Home hemodialysis & transitional care $11.4B U.S. TAM Company estimates based on data contained in USRDS 2021 Annual Data Report
The home market is significantly underpenetrated HOME CARE REIMBURSEMENT Medicare reimbursement misaligned with treatment frequency Historical barriers INCENTIVES Inadequate provider payment incentives TECHNOLOGY Cumbersome technology and training
The home market is poised for change. Outset’s commercial strategy is designed to capitalize on it HOME CARE New financial incentives Medicare Advantage eligibility Clinic staffing shortages Patient preferences
Tablo addresses key barriers to home dialysis adoption and retention HOME CARE 5–6 Treatments per week 100 hours Training per patient 16–24 hours Dialysate prep time per week Historical device 3 Treatments per week <25 hours Training per patient 0 hours Dialysate prep time
HOME CARE Tablo changes the home benefit-burden ratio Patients report fewer symptoms on Tablo Patient-reported outcomes survey comparing in-clinic treatments on Tablo vs their previous dialysis machine Felt more energized after dialysis 34% Reported less cramping during treatment 61% Felt more relaxed during treatment 48% Had fewer headaches after dialysis 47% Reported fewer alarms during treatment 78% ~10% Controllable attrition Adherence to prescribed home treatment frequency 99% Dropout during in-home period 0% Data from Outset 2019 IDE trial; Alvarez L, May Y, Chertow G, .Early Patient Experience with the Tablo Hemodialysis System; Outset Data Registry, 2022. For additional clinical evidence, visit https://www.outsetmedical.com/clinical- evidence/
Commercial strategy Clinic DRIVERS / BENEFITS New revenue stream Attractive contribution margin Discharge management solution Acute Home DRIVERS / BENEFITS Higher patient adoption of home Faster training Longer retention
A highly efficient business model SINGLE PLATFORM RECURRING REVENUE : ACUTE ~$20K per console per year RECURRING REVENUE : HOME ~$15K per console per year ONGOING REVENUE Initial console purchase generates recurring and predictable consumable and service revenue INITIAL CONSOLE PURCHASE
Strong financial position exiting 2022 Revenue 175% CAGR 2018–2022e ~$115M $261M Cash at Sept. 30, 2022 Secured up to additional $300M in debt financing 4,000 Consoles deployed (cumulative installed base at period end) 3,200 with acute/ sub-acute providers, nearly 800 with home providers ~800 bps Expected gross margin expansion Consistent year-over-year progress toward 50% gross margin milestone
2023 outlook Non-GAAP gross margin ~20% full year Mid-20% range exiting Q4 Commercial execution Land and expand in the Acutes High growth, high retention focus in the Home Revenue guidance $140M–$150M ~22–30% year-over-year growth
Outset Medical 3052 Orchard Drive San Jose, CA 95134 outsetmedical.com 35