Outset Medical, Inc. (OM) came out with a quarterly loss of $0.57 per share versus the Zacks Consensus Estimate of a loss of $0.53. This compares to loss of $0.72 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -7.55%. A quarter ago, it was expected that this company would post a loss of $0.61 per share when it actually produced a loss of $0.59, delivering a surprise of 3.28%.Over the last four quarters, the company has surpas ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39513 Outset Medical, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 20-0514392 (State or other jurisdictio ...

Exhibit 99.1 Outset Medical Reports First Quarter 2024 Financial Results San Jose, CA – May 8, 2024 – 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 financial results for the first quarter ended March 31, 2024. "With our recent 510(k) clearance for TabloCart with Prefiltration, 12 th consecutive quarter of gross margin expansion and strong sales pipeline growth ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39513 Outset Medical, Inc. (Exact name of Registrant as specified in its Charter) Delaware 20-0514392 Washington, D.C. 20549 (State or other jurisdiction of ...

Financial Performance - Total revenue for the three months ended September 30, 2023, was $30.4 million, an increase from $27.8 million in the same period of 2022, representing an increase of 9.3% year-over-year[80]. - For the nine months ended September 30, 2023, total revenue was $99.9 million, compared to $83.4 million for the same period in 2022, reflecting a year-over-year increase of 19.7%[80]. - Total revenue for Q3 2023 was $30.362 million, a 9% increase from $27.761 million in Q3 2022, and for the nine months ended September 30, 2023, total revenue was $99.869 million, a 20% increase from $83.368 million in the same period of 2022[93][94]. - Product revenue increased by $1.792 million, or 8%, in Q3 2023 compared to Q3 2022, driven by a $4.2 million increase in consumables revenue, partially offset by a $2.4 million decrease in console revenue[93][94]. - Gross profit for Q3 2023 was $7.157 million, a 65% increase from $4.336 million in Q3 2022, with gross margin improving to 23.6% from 15.6%[98]. - The company incurred a net loss of $134.2 million for the nine months ended September 30, 2023, which contributed to the cash outflow from operating activities[112]. - Net losses for the three months ended September 30, 2023, were $46.2 million, compared to $40.8 million for the same period in 2022, indicating an increase in losses of 13.3%[81]. - Net loss for Q3 2023 was $46.180 million, compared to a net loss of $40.781 million in Q3 2022, reflecting ongoing financial pressures[93]. Operational Strategy - Tablo has demonstrated the potential to reduce dialysis program costs by up to 80% in intensive care units, showcasing significant operational efficiencies[74]. - The company has focused on expanding its installed base in the acute care market, targeting Integrated Delivery Networks (IDNs) and skilled nursing facilities (SNFs) to drive utilization and fleet expansion[83]. - The company has implemented a strategy to insource console manufacturing and move production of Tablo cartridges to Mexico, aiming to reduce costs and improve gross margins[86]. - The company launched a pilot clinical and administrative services program in 2022 to assist healthcare providers transitioning to on-site inpatient dialysis services, which may face challenges in meeting customer expectations[91]. Financial Position and Cash Flow - The accumulated deficit as of September 30, 2023, reached $923.1 million, highlighting the ongoing financial challenges faced by the company[81]. - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $194.0 million, with a total liquidity balance of $197.3 million including restricted cash[108]. - For the nine months ended September 30, 2023, the company reported a net cash used in operating activities of $106.9 million, compared to $111.2 million for the same period in 2022[111]. - The net cash provided by investing activities was $59.6 million for the nine months ended September 30, 2023, primarily due to maturities of short-term investment securities of $183.3 million[113]. - The net cash provided by financing activities was $10.4 million for the nine months ended September 30, 2023, resulting from employee exercises of stock options and ESPP purchases[114]. Market Challenges - The company is facing macroeconomic challenges, including rising labor costs and supply chain disruptions, which may impact operations and customer demand[87]. - The company observed an increase in customer deferrals for purchasing Tablo due to rising interest rates and cautious capital spending, which is expected to continue into 2024[96][97]. - The company anticipates that the negative impacts from a recent Warning Letter and distribution pause will continue through at least the end of 2023, potentially affecting revenues[96]. Interest Income and Expenses - Interest income for Q3 2023 was $2.573 million, a 220% increase from $805,000 in Q3 2022, driven by higher interest rates[106]. - Interest expense for Q3 2023 was $3.213 million, a 467% increase from $567,000 in Q3 2022, due to higher outstanding balances under the SLR Term Loan Facility[107]. Future Outlook - The company expects to continue incurring significant expenses and operating losses in the near term while investing for anticipated growth[110]. - The company may raise additional capital through equity or debt financing, which could dilute existing stockholders' ownership interests[110]. Accounting Policies - The company adopted a recoupment policy in April 2023 for incentive compensation based on incorrect financial performance measures, in compliance with SEC rules[117]. - There have been no significant changes in critical accounting policies and estimates compared to the previous year[116]. - The company's exposure to market risks related to interest rates and foreign currency exchange rates has not changed materially since December 31, 2022[118].

0% Dropout during in-home period 99% ~10% Reported less cramping during treatment | --- | --- | |--------------------------------------------|-------| | | | | 61% | | | | | | Felt more relaxed during treatment | | | 48% | | | | | | Had fewer headaches after dialysis | | | 47% | | Commercial strategy Acute DRIVERS / BENEFITS New revenue stream Attractive contribution margin Discharge management solution Home | --- | --- | --- | --- | |------------------------------------|-------|-------|-------| | capitalize ...

Financial Data and Key Metrics Changes - The second quarter revenue increased 7.7% sequentially and 43.8% year-over-year to $36 million, driven by higher console placements and associated consumables pull-through [18][29] - Gross margin expanded for the ninth consecutive quarter to 22.5%, an improvement of 221 basis points sequentially and over 6.7 percentage points year-over-year [41][29] - The company reported a GAAP net loss of $44 million, resulting in a net loss of $0.90 per share, compared to a net loss of $43.8 million or $0.92 per share for the prior year period [42] Business Line Data and Key Metrics Changes - Product revenue was up 5.6% from the prior quarter and increased 49.5% year-over-year to $29.3 million, with strong console placements in both acute and home markets [18][55] - Service and other revenue of $6.7 million was up 17.9% from the prior quarter and higher by 23.4% compared to the prior year, driven by the growth of the installed base [19] - Consumable revenue was $9.6 million, up 8.2% from the prior quarter and an increase of 50.9% versus the prior year [40] Market Data and Key Metrics Changes - The acute care market showed strong comp flow growth, driven by insourcing initiatives, with more customers recognizing the cost savings associated with bringing Tablo in-house [8][25] - The company signed new insourcing agreements with a large number of hospitals, indicating a healthy pipeline of opportunities [8][30] - In the subacute provider market, master sales and service agreements were signed with all top 10 providers, with one example showing a 50% reduction in dialysis costs [32] Company Strategy and Development Direction - The company aims to expand its home dialysis programs by securing commitments from large health systems and achieving a majority presence among midsized dialysis operators [35][36] - The strategy includes a land-and-expand model, focusing on increasing the number of patients using Tablo at home while maintaining a high retention rate [36][15] - The company is committed to reaching a gross margin of 50% and continues to focus on cost-down programs, consumable pull-through, and service leverage as key drivers [20][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the improving macro environment and the company's ability to execute its strategic goals, despite a warning letter from the FDA [5][62] - The company anticipates that the impact of deferred Tablo orders will disproportionately affect the third quarter, with expectations for sequential growth in the fourth quarter [44][60] - Management highlighted a strong pipeline and backlog, indicating robust demand for Tablo across both acute and home markets [29][60] Other Important Information - The company received a warning letter from the FDA regarding observations from an inspection, but emphasized that these did not pertain to safety, efficacy, or quality [6][7] - The company plans to submit a 510(k) for the TabloCart with prefiltration by the end of August, which is expected to impact revenue in the second half of 2023 [28][59] - The company ended the quarter with approximately $226.1 million in cash and equivalents, indicating a strong liquidity position [58] Q&A Session Summary Question: Why is the company guiding to the lower end of the range despite beating expectations? - Management explained that the guidance reflects potential deferrals of Tablo orders and revenue from TabloCart with prefiltration, which is expected to be deferred [49][65] Question: How does the company plan to address the impact of the FDA warning letter? - Management stated that their immediate focus is on remediating the observations and that they have a strong track record of successful 510(k) submissions [72][94] Question: What is the outlook for home dialysis adoption? - Management noted that discharge issues in hospitals are driving interest in home programs, and they anticipate this will be a major driver in 2024 [110][116] Question: How is the competitive landscape affecting the company's strategy? - Management indicated that they have not seen significant changes in competition, and the trend of hospitals seeking to in-source dialysis services continues to be a tailwind for the company [111][112]

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) Delaware 20-0514392 (State or other jurisdiction of incorporation or organization) 3052 Orchard Dr. San Jose, California 95134 (Address of principal executive offices) (Zip Code) For the quarterly period ended June 30, 2023 (I.R.S. Employer Identification No.) OR Registrant's telephone number, including area code: (669) 231-8200 ...

| --- | --- | --- | |-------|-------|-------| | | | | | | | | | | | | Forward-looking statements and non-GAAP information 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," "es ...

Financial Data and Key Metrics Changes - The company's Q1 2023 revenue increased approximately 9.5% year-over-year to $33.5 million, exceeding expectations [18] - Non-GAAP gross margin for Q1 was 20.3%, representing an improvement of over 5 percentage points compared to the prior year [22] - Operating expenses in Q1 were $41.7 million, up $5.7 million year-over-year, with a GAAP net loss of $44 million [24] Business Line Data and Key Metrics Changes - Product revenue increased 8.2% year-over-year to $27.8 million, with console revenue growing 4.5% year-over-year to $18.9 million [19] - Consumable revenue was $8.9 million, up 17.1% year-over-year, driven by an expanding installed base [20] - Service and other revenue increased 16.4% year-over-year to $5.7 million, with core service revenue growing approximately 65% year-over-year [21] Market Data and Key Metrics Changes - The company added over 30 new hospital sites in Q1, marking the largest quarterly growth in new sites since 2021 [72] - The acute care environment has stabilized, with improvements in staffing levels observed [4] - The home market strategy focuses on increasing the number of home programs and patient census, with significant progress made in establishing relationships with major dialysis operators [6][41] Company Strategy and Development Direction - The company aims to drive utilization across its installed base and expand its footprint in U.S. hospitals, emphasizing the clinical and economic value of Tablo [3][16] - The strategy includes growing home dialysis programs while maintaining a high retention rate, which is seen as a key driver for profitable expansion [5][11] - The company is committed to achieving a gross margin of 50% in the long term, with ongoing initiatives to reduce costs and improve efficiency [12][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to execute the 2023 plan, citing strong Q1 performance and a healthy pipeline [34][66] - The company anticipates continued demand for Tablo, driven by its economic value proposition and the ongoing staffing challenges in the dialysis sector [56][96] - Management noted that hospitals are increasingly interested in in-sourcing dialysis services to control costs and improve operational efficiencies [89][103] Other Important Information - The company has raised its full-year 2023 revenue guidance to a range of $144 million to $150 million, reflecting a growth of approximately 25% to 30% over 2022 [26] - The gross margin guidance for 2023 has been increased to the low 20% range, with expectations to exit Q4 in the mid-20% range [27] - The company ended Q1 with approximately $252.5 million in cash and equivalents, indicating a strong liquidity position [25] Q&A Session Summary Question: Guidance and quarterly flow expectations - Management acknowledged the strong Q1 performance and expressed confidence in steady sequential growth throughout the year, despite the early stage of the year [33][35] Question: Home program progress and patient utilization - Management reported encouraging growth in the number of home patients per program and emphasized the potential for significant adoption of Tablo in home settings [38][42] Question: Capital equipment purchasing and utilization expectations - Management confirmed that Q1 saw expected seasonality in capital equipment purchasing but noted strong demand and treatment performance [45][46] Question: Gross margin outperformance and long-term expectations - Management highlighted ongoing margin expansion driven by cost reduction initiatives and disciplined pricing, with a focus on achieving mid-20% margins by year-end [49][51] Question: New hospital sites and staffing challenges - Management indicated that the addition of new hospital sites is expected to continue, driven by cost reduction interests, while staffing conditions have stabilized [56][64]