PROCEPT BioRobotics Corp

Previous wording

We are a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell the AquaBeam Robotic System, an advanced, image-guided, surgical robotic system for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. By 2060, it is expected that the number of men over 65 years old in the United States will double and include a corresponding increase in the number of men with enlarged prostates. The AquaBeam Robotic System employs a single-use disposable handpiece to deliver our proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. We believe that Aquablation therapy represents a paradigm shift in the surgical treatment of BPH by addressing compromises associated with alternative surgical interventions. We designed Aquablation therapy to deliver effective, safe and durable outcomes for males suffering from lower urinary tract symptoms, or LUTS, due to BPH that are independent of prostate size and shape. We have developed a significant and growing body of clinical evidence, which includes approximately 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy. As of March 31, 2024, we had an install base of 462 AquaBeam Robotic Systems globally, including 354 in the United States.

Current wording

We are a surgical robotics company focused on advancing patient care by developing transformative solutions in urology. We develop, manufacture and sell the AquaBeam Robotic System, an advanced, image-guided, surgical robotic system for use in minimally invasive urologic surgery, with an initial focus on treating benign prostatic hyperplasia, or BPH. BPH is the most common prostate disease and impacts approximately 40 million men in the United States. By 2060, it is expected that the number of men over 65 years old in the United States will double and include a corresponding increase in the number of men with enlarged prostates. The AquaBeam Robotic System employs a single-use disposable handpiece to deliver our proprietary Aquablation therapy, which combines real-time, multi-dimensional imaging, personalized treatment planning, automated robotics and heat-free waterjet ablation for targeted and rapid removal of prostate tissue. We believe that Aquablation therapy represents a paradigm shift in the surgical treatment of BPH by addressing compromises associated with alternative surgical interventions. We designed Aquablation therapy to deliver effective, safe and durable outcomes for males suffering from lower urinary tract symptoms, or LUTS, due to BPH that are independent of prostate size and shape. We have developed a significant and growing body of clinical evidence, which includes approximately 150 peer-reviewed publications, supporting the benefits and clinical advantages of Aquablation therapy. As of June 30, 2024, we had an install base of 516 AquaBeam Robotic Systems globally, including 400 in the United States.

Previous wording

We generated revenue of $44.5 million and incurred a net loss of $26.0 million for the three months ended March 31, 2024, compared to revenue of $24.4 million and a net loss of $28.5 million for the three months ended March 31, 2023. As of March 31, 2024, we had cash and cash equivalents of $225.6 million and an accumulated deficit of $480.5 million.

Current wording

We generated revenue of $97.9 million and incurred a net loss of $51.6 million for the six months ended June 30, 2024, compared to revenue of $57.5 million and a net loss of $53.8 million for the six months ended June 30, 2023. As of June 30, 2024, we had cash and cash equivalents of $214.1 million and an accumulated deficit of $506.2 million.

Previous wording

•Grow our install base of AquaBeam Robotic Systems: As of March 31, 2024, we had an install base of 462 AquaBeam Robotic Systems globally, including 354 in the United States. In the United States, we are initially focused on driving adoption of Aquablation therapy among urologists that perform hospital-based resective BPH surgery. We are initially targeting 860 high-volume hospitals that we estimate perform, on average, more than 200 resective procedures annually and account for approximately 70% of all hospital-based resective procedures. Additionally, there are approximately 1,840 additional U.S. hospitals that perform the remaining 30% of resective BPH procedures that we are targeting. To penetrate these hospitals, we expect to continue to increase our direct team of capital sales representatives, who are focused on driving system placement within hospitals by engaging with key surgeons and decision makers to educate them about the compelling value proposition of Aquablation therapy. As we increase our install base of AquaBeam Robotic systems we expect our revenue to increase as a result of the system sale and resulting utilization.

Current wording

•Grow our install base of AquaBeam Robotic Systems. As of June 30, 2024, we had an install base of 516 AquaBeam Robotic Systems globally, including 400 in the United States. In the United States, we are initially focused on driving adoption of Aquablation therapy among urologists that perform hospital-based resective BPH surgery. We are initially targeting 860 high-volume hospitals that we estimate perform, on average, more than 200 resective procedures annually and account for approximately 70% of all hospital-based resective procedures. Additionally, there are approximately 1,840 additional U.S. hospitals that perform the remaining 30% of resective BPH procedures that we are targeting. To penetrate these hospitals, we expect to continue to increase our direct team of capital sales representatives, who are focused on driving system placement within hospitals by engaging with key surgeons and decision makers to educate them about the compelling value proposition of Aquablation therapy. As we increase our install base of AquaBeam Robotic systems we expect our revenue to increase as a result of the system sale and resulting utilization.

Previous wording

Comparison of Three Months Ended March 31, 2024 and 2023

Current wording

Comparison of Three and Six Months Ended June 30, 2024 and 2023

Previous wording

Revenue increased $20.1 million, or 83%, to $44.5 million during the three months ended March 31, 2024, compared to $24.4 million during the three months ended March 31, 2023. The growth in revenue was primarily attributable to an increase of $18.4 million in revenue derived from the United States. The increase was due to higher sales volumes of system sales, handpieces, other consumables, and service contracts.

Current wording

Revenue increased $20.2 million, or 61%, to $53.4 million during the three months ended June 30, 2024, compared to $33.1 million during the three months ended June 30, 2023, and increased $40.4 million or 70% to $97.9 million during the six months ended June 30, 2024, compared to $57.5 million during the six months ended June 30, 2023. The growth in revenue was primarily attributable to an increase of $17.7 million and $36.2 million in revenue derived from the United States for the three and six months ended June 30, 2024, respectively. The increase was due to higher sales volumes of system sales, handpieces, other consumables, and service contracts.

Previous wording

Cost of sales increased $7.6 million, or 64%, to $19.5 million during the three months ended March 31, 2024, compared to $11.9 million during the three months ended March 31, 2023. The increase in cost of sales was primarily attributable to the growth in the number of units sold.

Current wording

$41.4 million during the six months ended June 30, 2024 compared to $26.6 million for the six months ended June 30, 2023. The increase in cost of sales was primarily attributable to the growth in the number of units sold.

Previous wording

Gross margin increased to 56% during the three months ended March 31, 2024, compared to 51% for the three months ended March 31, 2023. The increase in gross margin was primarily attributable to the growth in unit sales, which allowed us to spread the fixed portion of our manufacturing overhead costs over more production units, and to a lesser extent, an increase in average selling prices on both our system sales and handpieces.

Current wording

Gross margin increased to 59% during the three months ended June 30, 2024, compared to 56% for the three months ended June 30, 2023, and increased to 58% during the six months ended June 30, 2024 compared to 54% during the six months ended June 30, 2023. The increase in gross margin was primarily attributable to the growth in unit sales, which allowed us to spread the fixed portion of our manufacturing overhead costs over more production units, and to a lesser extent, an increase in average selling prices on both our system sales and handpieces.

Previous wording

R&D expenses increased $2.3 million, or 22%, to $13.1 million during the three months ended March 31, 2024, compared to $10.7 million during the three months ended March 31, 2023. The increase in R&D expenses was primarily due to employee-related expenses of our R&D organization such as salaries and wages, along with an increase in consultant expenses and tooling. These expenses support ongoing product improvements and the development of additional and next generation technologies.

Current wording

R&D expenses increased $5.9 million, or 51%, to $17.5 million during the three months ended June 30, 2024, compared to $11.6 million during the three months ended June 30, 2023, and increased $8.2 million or 37%, to $30.6 million during the six months ended June 30, 2024, compared to $22.4 million for the six months ended June 30, 2023. The increase in R&D expenses was primarily due to employee-related expenses of our R&D organization such as salaries and wages, along with an increase in consultant expenses and tooling. These expenses support ongoing product improvements and the development of additional and next generation technologies.

Previous wording

SG&A expenses increased $9.5 million, or 31%, to $39.6 million during the three months ended March 31, 2024, compared to $30.1 million during the three months ended March 31, 2023. The increase in SG&A expenses was primarily due to employee-related expenses of our sales and marketing organization such as salaries and wages and stock-based compensation expense, primarily to expand the commercial organization, and employee-related expenses of our administrative organization such as salaries and wages and stock-based compensation expense, to drive and support our growth in revenue.

Current wording

SG&A expenses increased $8.4 million, or 26%, to $40.8 million during the three months ended June 30, 2024, compared to $32.4 million during the three months ended June 30, 2023, and increased $17.8 million or 29%, to $80.4 million for the six months ended June 30, 2024 compared to $62.6 million for the six months ended June 30, 2023. The increase in SG&A expenses was primarily due to employee-related expenses of our sales and marketing organization such as salaries and wages and stock-based compensation expense, primarily to expand the commercial organization, and employee-related expenses of our administrative organization such as salaries and wages and stock-based compensation expense, to drive and support our growth in revenue.

Previous wording

Interest expense increased 0.2 million, or 18% to $1.0 million during the three months ended March 31, 2024, compared to $0.9 million during the three months ended March 31, 2023. The increase in interest expense was primarily due to an increase in the interest rate as compared to the prior period.

Current wording

Interest expense increased $0.2 million, or 12% to $2.1 million during the six months ended June 30, 2024, compared to $1.9 million during the six months ended June 30, 2023. The increase in interest expense was primarily due to an increase in the interest rate as compared to the prior period.

Previous wording

Interest and other income, net, increased $2.0 million for the three months ended March 31, 2024. The increase was primarily due to an increase in interest income, which was due to our increase cash balance with increases in interest rates.

Current wording

Interest and other income, net, increased $0.9 million and $2.9 million for the three and six months ended June 30, 2024 compared to the three and six months ended June 30, 2023. The increase was primarily due to an increase in interest income, which was due to our increase cash balance with increases in interest rates.

Previous wording

As of March 31, 2024, we had cash and cash equivalents of $225.6 million, an accumulated deficit of $480.5 million, and $52.0 million outstanding on our loan facility. We expect our expenses will increase for the foreseeable future, in particular as we continue to make substantial investments in sales and marketing, operations and research and development. Moreover, we expect to incur additional expenses as a result of operating as a public company, including legal, accounting, insurance, compliance with the rules and regulations of the SEC and those of any stock exchange on which our securities are traded, investor relations, and other administrative and professional services expenses. Our future funding requirements will depend on many factors, including:

Current wording

As of June 30, 2024, we had cash and cash equivalents of $214.1 million, an accumulated deficit of $506.2 million, and $52.0 million outstanding on our loan facility. We expect our expenses will increase for the foreseeable future, in particular as we continue to make substantial investments in sales and marketing, operations and research and development. Our future funding requirements will depend on many factors, including:

Previous wording

In October 2022, we entered into a loan and security agreement with Canadian Imperial Bank of Commerce. The agreement provides for a senior secured term loan facility in the aggregate principal amount of $52.0 million, which was borrowed in full. Proceeds from the term loan facility were used to repay and terminate our previous loan facility, and to pay transaction fees, and related expenses.

Current wording

In October 2022, we entered into a loan and security agreement with Canadian Imperial Bank of Commerce. The agreement provides for a senior secured term loan facility in the aggregate principal amount of $52.0 million, which was borrowed in full.

Previous wording

During the three months ended March 31, 2024, net cash used in operating activities was $32.3 million, consisting primarily of a net loss of $26.0 million and an increase in net operating assets of $13.7 million, partially offset by non-cash charges of $7.4 million. The cash used in operations was primarily due to our net loss due to the increase in operating expenses to support our commercialization and development activities. The expansion of our commercialization activities resulted in an increase in accounts receivable, inventory, and prepaid expenses and other current assets, partially offset by a decrease in accounts payable, due to timing of payments, and reimbursements for leasehold improvements made related to our San Jose, California corporate headquarters. Non-cash charges consisted primarily of stock-based compensation, non-cash lease expense, and depreciation.

Current wording

During the six months ended June 30, 2024, net cash used in operating activities was $48.0 million, consisting primarily of a net loss of $51.6 million and an increase in net operating assets of $13.9 million, partially offset by non-cash charges of $17.5 million. The cash used in operations was primarily due to our net loss due to the increase in operating expenses to support our commercialization and development activities. The expansion of our commercialization activities resulted in an increase in accounts receivable and inventory, partially offset by reimbursements for leasehold improvements made related to our San Jose, California corporate headquarters and an increase to other liabilities. Non-cash charges consisted primarily of stock-based compensation, non-cash lease expense, and depreciation.

Previous wording

During the three months ended March 31, 2023, net cash used in operating activities was $35.9 million, consisting primarily of a net loss of $28.5 million and an increase in net operating assets of $12.7 million, partially offset by non-cash charges of $5.3 million. The cash used in operations was primarily due to our net loss due to the increase in operating expenses to support our commercialization and development activities. The expansion of our commercialization resulted in an increase in accounts receivable, inventory, and accounts payable, partially offset by a decrease in accrued compensation, due to timing of payments, and reimbursements for leasehold improvements made related to our San Jose, California corporate headquarters. Non-cash charges consisted primarily of stock-based compensation, non-cash lease expense and depreciation.

Current wording

During the six months ended June 30, 2023, net cash used in operating activities was $64.3 million, consisting primarily of a net loss of $53.8 million and an increase in net operating assets of $21.5 million, partially offset by non-cash charges of $11.0 million. The cash used in operations was primarily due to our net loss due to the increase in operating expenses to support our commercialization and development activities. The expansion of our commercialization resulted in an increase in accounts receivable, inventory, and accounts payable, partially offset by reimbursements for leasehold improvements made related to our San Jose, California corporate headquarters, and an increase to other liabilities. Non-cash charges consisted primarily of stock-based compensation, non-cash lease expense and depreciation.

Previous wording

During the three months ended March 31, 2024, net cash used in investing activities was $1.9 million, consisting of purchases of property and equipment. During the three months ended March 31, 2023, net cash used in investing activities was $5.3 million, consisting of purchases of property and equipment.

Current wording

During the six months ended June 30, 2024, net cash used in investing activities was $3.0 million, consisting of purchases of property and equipment. During the six months ended June 30, 2023, net cash used in investing activities was $10.7 million, consisting of purchases of property and equipment.

Previous wording

During the three months ended March 31, 2024, net cash provided by financing activities was $2.6 million, consisting of proceeds from exercises of stock options. During the three months ended March 31, 2023, net cash provided by financing activities was $0.4 million, consisting of proceeds from exercises of stock options.

Current wording

During the six months ended June 30, 2024, net cash provided by financing activities was $7.9 million, consisting of proceeds from exercises of stock options and proceeds from the issuance of common stock under the ESPP. During the six months ended June 30, 2023, net cash provided by financing activities was $2.8 million, consisting of proceeds from exercises of stock options and proceeds from the issuance of common stock under the ESPP.