Evolus Inc
For the period ended Sep 30, 2024. Filed Nov 6, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 6, 2024
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-07-31.
0001570562-24-000116
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-06.
0001570562-24-000128
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 127 previous paragraphs and 125 current paragraphs.
84 unchanged; 39 reworded; 2 added; 2 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (2)
Current report
Comparison of the Nine Months Ended September 30, 2024 and 2023
Current report
In-process Research and Development
Removed paragraphs (2)
Previous report
Comparison of the Six Months Ended June 30, 2024 and 2023
Previous report
Follow-On Offering
Reworded paragraphs (39)
Previous wording
We are a global performance beauty company with a customer-centric approach to delivering breakthrough products in the cash-pay aesthetic market. Our first product, Jeuveau® (prabotulinumtoxinA-xvfs), is currently sold in the United States, Canada and certain European countries. We have commercial launch plans in additional countries where we have obtained regulatory approval, which we expect to implement in the next few years. We are also actively pursuing regulatory approval of Evolysse™, a line of hyaluronic acid dermal fillers that includes mid face, nasolabial folds, lips and eyes. Regulatory approval has already been received for the Evolysse™ nasolabial fold product in Europe, and we anticipate obtaining regulatory approvals for the remaining three Evolysse™ line of products in Europe in late 2024 and in the United States beginning in 2025. In June 2024, we submitted a premarket approval (“PMA”) application to the U.S. Food and Drug Administration (the “FDA”) for the Evolysse™ Lift and Evolysse™ Smooth dermal filler products for the nasolabial fold.
Current wording
We are a global performance beauty company with a customer-centric approach to delivering breakthrough products in the cash-pay aesthetic market. Our first product, Jeuveau® (prabotulinumtoxinA-xvfs), is currently sold in the United States, Canada, certain European countries and Australia. We have commercial launch plans in additional countries which we expect to implement in the next few years. We are also actively pursuing regulatory approval of Evolysse™, a line of injectable hyaluronic acid gels that includes mid face, nasolabial folds, lips and eyes. In October 2024, regulatory approval was received in the European Union for four products in the Evolysse™ line: Evolysse™ Form, Evolysse™ Smooth, Evolysse™ Sculpt and Evolysse™ Lips. In June 2024, we submitted a premarket approval (“PMA”) application to the U.S. Food and Drug Administration (the “FDA”) for Evolysse™ Form and Evolysse™ Smooth injectable hyaluronic acid gels for wrinkles and folds, such as nasolabial folds. We anticipate obtaining regulatory approvals in the United States for Evolysse™ Form and Evolysse™ Smooth by September 2025.
Previous wording
Jeuveau® is a proprietary 900 kDa purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as “frown lines,” in adults. Evolysse™, a line of dermal fillers, is a first-generation cold technology hyaluronic acid line for products including mid face, nasolabial folds, lips and eyes. Our primary market is the cash-pay aesthetic market, which consists of medical products that consumers pay for directly out of pocket. Our customers are aesthetic practitioners who are properly licensed to deliver our products. By avoiding the regulatory burdens that accompany reimbursed products and pursuing an aesthetic-only non-reimbursed product strategy, we create flexibility to deliver a unique value proposition to our customers. We utilize this flexibility to drive customer adoption through programs such as our consumer loyalty program, co-branded marketing programs, promotional events and pricing strategies.
Current wording
Jeuveau® is a proprietary 900 kDa purified botulinum toxin type A formulation indicated for the temporary improvement in the appearance of moderate to severe glabellar lines, also known as “frown lines,” in adults. Evolysse™, a line of injectable hyaluronic acid gels, is a first-generation cold technology line of hyaluronic acid gels for products including mid face, nasolabial folds, lips and eyes. Our primary market is the cash-pay aesthetic market, which consists of medical products that consumers pay for directly out of pocket. Our customers are aesthetic practitioners who are properly licensed to deliver our products. By avoiding the regulatory burdens that accompany reimbursed products and pursuing an aesthetic-only non-reimbursed product strategy, we create flexibility to deliver a unique value proposition to our customers. We utilize this flexibility to drive customer adoption through programs such as our consumer loyalty program, co-branded marketing programs, promotional events and pricing strategies.
Previous wording
We currently operate in one reportable segment, and all of our net revenues are derived from sales of Jeuveau®. Net revenues consist of revenues, net of adjustments primarily for customer rebates, rewards related to the consumer loyalty program and co-branded marketing programs. Revenues are recognized when the control of the promised goods is transferred to the customer in an amount that reflects the consideration allocated to the related performance obligations and to which we expect to be entitled in exchange for those products or services.
Current wording
We currently operate in one reportable segment, and all of our net revenues are derived from sales of Jeuveau®, our sole commercial product to date. Net revenues consist of revenues, net of adjustments primarily for customer rebates, rewards related to the consumer loyalty program and co-branded marketing programs. Revenues are recognized when the control of the promised goods is transferred to the customer in an amount that reflects the consideration allocated to the related performance obligations and to which we expect to be entitled in exchange for those products or services.
Previous wording
Net revenues of Jeuveau® sales increased by $17.6 million, or 35.7%, to $66.9 million for the three months ended June 30, 2024 from $49.3 million for the three months ended June 30, 2023, primarily due to higher sales volumes. Net revenues during each of the three months ended June 30, 2024 and 2023 consisted of $0.7 million of service revenue from the sale of Jeuveau®through a distribution partner in Canada. We anticipate our continued sales growth will depend on our ability to grow our customer base and increase purchases by our current customers in the competitive medical aesthetic market as well as on regulatory approval for the Evolysse™ dermal filler product line in the United States and Europe by Symatese and subsequent commercial launch of these products.
Current wording
Net revenues of Jeuveau® sales increased by $11.1 million, or 22.2%, to $61.1 million for the three months ended September 30, 2024 from $50.0 million for the three months ended September 30, 2023, primarily due to higher sales volumes. Net revenues during the three months ended September 30, 2024 and 2023 consisted of $0.9 million and $0.7 million, respectively, of service revenue from the sale of Jeuveau®through a distribution partner in Canada. We anticipate our continued sales growth will depend on our ability to successfully continue to penetrate the market, grow our customer base and increase purchases by our current customers in the competitive medical aesthetic market, as well as on obtaining regulatory approval for the Evolysse™ injectable hyaluronic acid gel line in the United States by Symatese and subsequent successful commercial launch of these products.
Previous wording
Product cost of sales, excluding amortization of intangible assets, increased by $4.4 million, or 29.9%, to $19.1 million for the three months ended June 30, 2024 from $14.7 million for the three months ended June 30, 2023, primarily due to higher sales volume. We anticipate that our product cost of sales will fluctuate in line with changes in revenues.
Current wording
Product cost of sales, excluding amortization of intangible assets, increased by $2.8 million, or 18.2%, to $18.2 million for the three months ended September 30, 2024 from $15.4 million for the three months ended September 30, 2023, primarily due to higher sales volume. We anticipate that our product cost of sales will fluctuate in line with changes in revenues until the expiration of the Medytox royalty obligation in September 2032.
Previous wording
Our gross profit margin was 70.3% and 68.7% for the three months ended June 30, 2024 and 2023, respectively. Our gross profit margin has been and will continue to be negatively impacted from September 2022 to September 2032 as we pay royalty obligations related to our litigation settlement agreement. See “—Liquidity and Capital Resources—Litigation Settlement” for further information. We also anticipate our gross profit margin will fluctuate as we implement various marketing programs that may affect the average selling price for Jeuveau® and as we continue to expand internationally.
Current wording
Our gross profit margin was 68.9% and 67.7% for the three months ended September 30, 2024 and 2023, respectively. Our gross profit margin has been and will continue to be negatively impacted from September 2022 to September 2032 as we pay royalty obligations related to our litigation settlement agreement. See “—Liquidity and Capital Resources—Litigation Settlement” for further information. We also anticipate our gross profit margin will fluctuate as we implement various marketing programs that may affect the average selling price for Jeuveau® and as we continue to expand internationally.
Previous wording
Selling, general and administrative expenses increased by $9.0 million, or 21.8%, to $50.2 million for the three months ended June 30, 2024 from $41.2 million for the three months ended June 30, 2023, primarily resulting from increasing personnel costs related to our commercial activities. Selling, general and administrative expenses may fluctuate in the future primarily due to potential changes in marketing strategies and international launches.
Current wording
Selling, general and administrative expenses increased by $9.2 million, or 21.2%, to $52.5 million for the three months ended September 30, 2024 from $43.3 million for the three months ended September 30, 2023, primarily resulting from increasing personnel costs related to our commercial activities. Selling, general and administrative expenses may fluctuate in the future primarily due to potential changes in marketing strategies and international launches.
Previous wording
Research and development expenses increased by $1.2 million to $2.4 million for the three months ended June 30, 2024 from $1.2 million for the three months ended June 30, 2023. The increase was primarily attributable to increasing our clinical operations and research and development expenses related to increased clinical operations and research. We expect our research and development expenses to continue to increase if and when we develop further product candidates and as we pursue regulatory approvals in other jurisdictions for our current products.
Current wording
Research and development expenses increased by $0.7 million to $2.3 million for the three months ended September 30, 2024 from $1.6 million for the three months ended September 30, 2023. The increase was primarily attributable to our clinical operations and research and development expenses related to obtaining regulatory approvals of Evolysse™ in the United States and European countries. We expect our research and development expenses to continue to increase if and when we develop further product candidates and as we pursue regulatory approvals in other jurisdictions for our current products.
Previous wording
The change in the fair value of the contingent royalty obligation payable to Evolus Founders is recorded in operating expenses in each reporting period. During the three months ended June 30, 2024 and 2023, the revaluation charges of $1.6 million and $1.7 million, respectively, were primarily driven by changes in management assumptions relating to revenue forecasts, the discount rate used and the timing of cash flows.
Current wording
The change in the fair value of the contingent royalty obligation payable to Evolus Founders is recorded in operating expenses in each reporting period. During the three months ended September 30, 2024 and 2023, the revaluation charges of $2.4 million and $1.8 million, respectively, were primarily driven by changes in management assumptions relating to revenue forecasts, the discount rate used and the timing of cash flows.
Previous wording
Depreciation and amortization increased by $0.2 million, or 16.7%, to $1.4 million for the three months ended June 30, 2024 from $1.2 million for the three months ended June 30, 2023, primarily due to an increase in amortization of internal use software and leasehold improvements.
Current wording
Depreciation and amortization decreased by $0.2 million, or 15.4%, to $1.1 million for the three months ended September 30, 2024 from $1.3 million for the three months ended September 30, 2023.
Previous wording
Non-operating expense, net, increased by $2.2 million, or 38.6%, to $7.9 million for the six months ended June 30, 2024 from $5.7 million for the six months ended June 30, 2023, primarily due to the advancement of the $50.0 million of term loans in 2023 and higher interest expense for our term loans. Interest on our term loans is based on a variable interest rate, which we expect will continue to fluctuate with the market. See “—Liquidity and Capital Resources—The Pharmakon Term Loans” for further information.
Current wording
Non-operating expense, net, increased by $0.3 million, or 8.6%, to $3.8 million for the three months ended September 30, 2024 from $3.5 million for the three months ended September 30, 2023, primarily due to higher interest expense for our term loans. Interest on our term loans is based on a variable interest rate, which we expect will continue to fluctuate with the market. See “—Liquidity and Capital Resources—The Pharmakon Term Loans” for further information.
Previous wording
Net revenues of Jeuveau® sales increased by$35.2 million, or 38.6%, to$126.2 million for the six months ended June 30, 2024 from $91.1 million for the six months ended June 30, 2023, primarily due to higher sales volumes. Net revenues during the six months ended June 30, 2024 and 2023 consisted of $1.1 million and $1.3 million, respectively, of service revenue from the sale of Jeuveau®through a distribution partner in Canada. We anticipate our continued sales growth will depend on our ability to grow our customer base and increase purchases by our current customers in the competitive medical aesthetic market as well as on regulatory approval for the Evolysse™ dermal filler product line in the United States and Europe by Symatese and subsequent commercial launch of these products.
Current wording
Net revenues of Jeuveau® sales increased by$46.3 million, or 32.8%, to$187.3 million for the nine months ended September 30, 2024 from $141.1 million for the nine months ended September 30, 2023, primarily due to higher sales volumes. Net revenues during the nine months ended September 30, 2024 and 2023 consisted of $2.0 million and $2.0 million, respectively, of service revenue from the sale of Jeuveau®through a distribution partner in Canada. We anticipate our continued sales growth will depend on our ability to grow our customer base and increase purchases by our current customers in the competitive medical aesthetic market as well as on regulatory approval for the Evolysse™ injectable hyaluronic acid gel line in the United States by Symatese and subsequent commercial launch of these products.
Previous wording
Product cost of sales, excluding amortization of intangible assets, increased by $10.2 million, or 37.9%, to $37.1 million for the six months ended June 30, 2024 from $26.9 million for the six months ended June 30, 2023, primarily due to reduced royalty obligations to Medytox, offset by an increase due to higher sales volume. We anticipate that our product cost of sales will fluctuate in line with changes in revenues until the expiration of the Medytox royalty obligation in September 2032.
Current wording
Product cost of sales, excluding amortization of intangible assets, increased by $13.1 million, or 31.0%, to $55.4 million for the nine months ended September 30, 2024 from $42.3 million for the nine months ended September 30, 2023, primarily due to higher sales volume. We anticipate that our product cost of sales will fluctuate in line with changes in revenues until the expiration of the Medytox royalty obligation in September 2032.
Previous wording
Our gross profit margin was 69.4% and 68.9% for the six months ended June 30, 2024 and 2023, respectively. Our gross profit margin has been and will continue to be negatively impacted to a lesser extent from September 2022 to September 2032 as we pay royalty obligations related to our litigation settlement agreement. See “—Liquidity and Capital Resources—Litigation Settlement” for further information. We also anticipate our gross profit margin will fluctuate as we implement various marketing programs that may affect the average selling price for Jeuveau® and as we continue to expand internationally.
Current wording
Our gross profit margin was 69.2% and 68.5% for the nine months ended September 30, 2024 and 2023, respectively. Our gross profit margin has been and will continue to be negatively impacted from September 2022 to September 2032 as we pay royalty obligations related to our litigation settlement agreement. See “—Liquidity and Capital Resources—Litigation Settlement” for further information. We also anticipate our gross profit margin will fluctuate as we implement various marketing programs that may affect the average selling price for Jeuveau® and as we continue to expand internationally.
Previous wording
Selling, general and administrative expenses increased by $16.7 million, or 21.2%, to $95.3 million for the six months ended June 30, 2024 from $78.6 million for the six months ended June 30, 2023, primarily resulting from increasing personnel costs related to our commercial expansion. Selling, general and administrative expenses may fluctuate in the future primarily due to potential changes in marketing strategies and international launches.
Current wording
Selling, general and administrative expenses increased by $25.9 million, or 21.2%, to $147.8 million for the nine months ended September 30, 2024 from $121.9 million for the nine months ended September 30, 2023, primarily resulting from increasing personnel costs related to our commercial expansion. Selling, general and administrative expenses may fluctuate in the future primarily due to potential changes in marketing strategies and international launches.
Previous wording
Research and development expenses increased by $1.8 million to $4.4 million for the six months ended June 30, 2024 from $2.6 million for the six months ended June 30, 2023. We expect our research and development expenses to continue to increase if and when we develop further product candidates and as we pursue regulatory approvals in other jurisdictions.
Current wording
Research and development expenses increased by $2.5 million to $6.7 million for the nine months ended September 30, 2024 from $4.2 million for the nine months ended September 30, 2023. The increase was primarily attributable to our clinical operations and research and development expenses related to obtaining regulatory approvals of Evolysse™ in the United States and European countries. We expect our research and development expenses to continue to increase if and when we develop further product candidates and as we pursue regulatory approvals in other jurisdictions.
Previous wording
For the three months ended June 30, 2023, we recorded $4.4 million of in-process research and development expense in connection with the Symatese Agreement. Refer to Note 2. Basis of Presentation and Summary of Significant Accounting Policies for additional information.
Current wording
For the nine months ended September 30, 2023, we recorded $4.4 million of in-process research and development expense in connection with the Symatese Agreement. Refer to Note 2. Basis of Presentation and Summary of Significant Accounting Policies for additional information.
Previous wording
The change in the fair value of the contingent royalty obligation payable to Evolus Founders is recorded in operating expenses in each reporting period. During the six months ended June 30, 2024 and 2023, the revaluation charges of $3.2 million and $3.3 million, respectively, were primarily driven by changes in management assumptions relating to revenue forecasts, the discount rate used and the timing of cash flows.
Current wording
The change in the fair value of the contingent royalty obligation payable to Evolus Founders is recorded in operating expenses in each reporting period. During the nine months ended September 30, 2024 and 2023, the revaluation charges of $5.6 million and $5.1 million, respectively, were primarily driven by changes in management assumptions relating to revenue forecasts, the discount rate used and the timing of cash flows.
Previous wording
Depreciation and amortization increased by $0.4 million, or 16.7%, to $2.8 million for the six months ended June 30, 2024 from $2.4 million for the six months ended June 30, 2023, primarily due to an increase in amortization of internal use software and leasehold improvements.
Current wording
Depreciation and amortization increased by $0.1 million, or 2.6%, to $3.9 million for the nine months ended September 30, 2024 from $3.8 million for the nine months ended September 30, 2023.
Previous wording
Non-operating expense, net, increased by $0.7 million, or 23.3%, to $3.7 million for the three months ended June 30, 2024 from $3.0 million for the three months ended June 30, 2023, primarily due to the advancement of the $50.0 million of term loans in 2023 and higher interest expense for our term loans. Interest on our term loans is based on a variable interest rate, which we expect will continue to fluctuate with the market. See “—Liquidity and Capital Resources—The Pharmakon Term Loans” for further information.
Current wording
Non-operating expense, net, increased by $2.5 million, or 27.2%, to $11.7 million for the nine months ended September 30, 2024 from $9.2 million for the nine months ended September 30, 2023, primarily due to the advancement of the $50.0 million of term loans in 2023 and higher interest expense for our term loans. Interest on our term loans is based on a variable interest rate, which we expect will continue to fluctuate with the market. See “—Liquidity and Capital Resources—The Pharmakon Term Loans” for further information.
Previous wording
There was minimal income tax expense for each of the six months ended June 30, 2024 and 2023.
Current wording
There was minimal income tax expense for each of the nine months ended September 30, 2024 and 2023.
Previous wording
As of June 30, 2024 we had cash and cash equivalents of $93.7 million, positive working capital of $104.0 million and stockholders’ equity of $19.3 million.
Current wording
As of September 30, 2024 we had cash and cash equivalents of $85.0 million, positive working capital of $89.5 million and stockholders’ equity of $5.9 million.
Previous wording
We began selling Jeuveau® in May 2019 and have a relatively limited history of generating revenues. Since inception, we have incurred recurring net operating losses and have an accumulated deficit of $583.4 million as of June 30, 2024 as a result of ongoing efforts to develop and commercialize Jeuveau®, including providing selling, general and administrative support for our operations. We had net loss of $24.5 million and $32.9 million for the six months ended June 30, 2024 and 2023, respectively. We had loss from operations of $16.6 million and $27.2 million for the six months ended June 30, 2024 and 2023, respectively. We used net cash of $17.1 million and $33.9 million in operating activities for the six months ended June 30, 2024 and 2023, respectively. We expect to continue to incur significant expenses for the foreseeable future as we increase marketing efforts for Jeuveau® in the U.S., Europe, and Canada, prepare to commercially launch Jeuveau® in other jurisdictions where we have obtained regulatory approval, including Australia, pursue regulatory approvals in other jurisdictions and prepare to commercially launch Evolysse™ Lift, Smooth, and Sculpt dermal filler product line.
Current wording
We began selling Jeuveau® in May 2019 and have a relatively limited history of generating revenues. Since inception, we have incurred recurring net operating losses and have an accumulated deficit of $602.6 million as of September 30, 2024 as a result of ongoing efforts to develop and commercialize Jeuveau®, including providing selling, general and administrative support for our operations. We had net loss of $43.6 million and $49.9 million for the nine months ended September 30, 2024 and 2023, respectively. We had loss from operations of $32.1 million and $40.6 million for the nine months ended September 30, 2024 and 2023, respectively. We used net cash of $22.8 million and $34.8 million in operating activities for the nine months ended September 30, 2024 and 2023, respectively. We expect to continue to incur significant expenses for the foreseeable future as we increase marketing efforts for Jeuveau® in the U.S., Europe, Canada, and Australia and prepare to commercially launch Jeuveau® in other jurisdictions where we have obtained regulatory approval pursue regulatory approvals in other jurisdictions and prepare to commercially launch Evolysse™ Form, Smooth, and Sculpt injectable hyaluronic acid gel line.
Previous wording
On March 8, 2023, we entered into an “at-the-market” sales agreement (the “ATM Sales Agreement”) and filed a shelf registration statement on Form S-3 and corresponding prospectus with the SEC to permit sales under the ATM Sales Agreement, which registration statement became effective on June 8, 2023. We have not sold any shares under the ATM Sales Agreement. See Note 9. Stockholders’ Equity in the Notes to the Condensed Consolidated Financial Statements in Part I, Item of this quarterly report for additional information.
Current wording
On March 8, 2023, we entered into an “at-the-market” sales agreement (the “ATM Sales Agreement”) and filed a shelf registration statement on Form S-3 and corresponding prospectus with the SEC to permit sales under the ATM Sales Agreement, which registration statement became effective on June 8, 2023. We have not sold any shares under the ATM Sales Agreement. See Note 9. Stockholders’ Equity in the Notes to the Condensed Consolidated Financial Statements in Part I, Item of this Quarterly Report on Form 10-Q for additional information.
Previous wording
We are obligated to make quarterly royalty payments of a low-single digit percentage of net sales of Jeuveau® to the Evolus Founders. These obligations terminate at the end of the second quarter of 2029. The fair value of the obligations is valued quarterly and is referred to in our condensed consolidated financial statements as the contingent royalty obligation.
Current wording
We are obligated to make quarterly royalty payments of a low-single digit percentage of net sales of Jeuveau® to the founders of Evolus (“Evolus Founders”). These obligations terminate at the end of the second quarter of 2029. The fair value of the obligations is valued quarterly and is referred to in our condensed consolidated financial statements as the contingent royalty obligation.
Previous wording
As of June 30, 2024, we recorded an aggregate balance of $44.6 million on our balance sheet for the future royalty payment obligation to Evolus Founders.
Current wording
As of September 30, 2024, we recorded an aggregate balance of $45.0 million on our balance sheet for the future royalty payment obligation to Evolus Founders.
Previous wording
In February 2021, we settled litigation claims related to a complaint against us filed by Allergan, Inc. and Allergan Limited (together, “Allergan”) and Medytox, Inc. (“Medytox”) in the U.S. International Trade Commission related to Jeuveau® (the “ITC Action”) and certain related matters by entering into a Settlement and License Agreement with Medytox and Allergan, which we refer to as the U.S. Settlement Agreement, and another Settlement and License Agreement with Medytox which we refer to as the Medytox Settlement Agreement. We refer to the U.S. Settlement Agreement and the ROW Settlement Agreement collectively as the Medytox/Allergan Settlement Agreements. In the first quarter of 2023, we made a final milestone payment of $5.0 million. Going forward, from September 17, 2022 to September 16, 2032, we will pay to Medytox a quarterly, mid-single digit royalty on net sales of Jeuveau®sold in other Evolus territories pursuant to the Medytox Settlement Agreement.
Current wording
In February 2021, we settled litigation claims related to a complaint against us filed by Allergan, Inc. and Allergan Limited (together, “Allergan”) and Medytox, Inc. (“Medytox”) in the U.S. International Trade Commission related to Jeuveau® (the “ITC Action”) and certain related matters by entering into a Settlement and License Agreement with Medytox and Allergan, which we refer to as the U.S. Settlement Agreement, and another Settlement and License Agreement with Medytox which we refer to as the Medytox Settlement Agreement. We refer to the U.S. Settlement Agreement and the ROW Settlement Agreement collectively as the Medytox. In the first quarter of 2023, we made a final milestone payment of $5.0 million. Going forward, from September 17, 2022 to September 16, 2032, we will pay to Medytox a quarterly, mid-single digit royalty on net sales of Jeuveau®sold in other Evolus territories pursuant to the Medytox Settlement Agreement.
Previous wording
In 2023, we entered into two agreements with Symatese S.A.S. and its affiliates (“Symatese”), which granted us exclusive rights to commercialize and distribute the Evolysse™ line of dermal fillers in the United States and 50 countries in Europe for aesthetic and dermatological uses. We refer to the agreement conveying rights in the United States as the “Symatese U.S. Agreement” and the agreement conveying rights in Europe as the “Symatese Europe Agreement.” In the United States, we obtained the rights to the Evolysse™ products referred to as (i) Lift; (ii) Smooth; (iii) Sculpt; (iv) Lips; and (v) Eye and in Europe we obtained the rights to (i) Lift; (ii) Smooth; (iii) Sculpt; and (iv) Lips.
Current wording
In 2023, we entered into two agreements with Symatese S.A.S. and its affiliates (“Symatese”), which granted us exclusive rights to commercialize and distribute the Evolysse™ line of injectable hyaluronic acid gels in the United States and 50 countries in Europe for aesthetic and dermatological uses. We refer to the agreement conveying rights in the United States as the “Symatese U.S. Agreement” and the agreement conveying rights in Europe as the “Symatese Europe Agreement.” In the United States, we obtained the rights to the Evolysse™ products referred to as (i) Form; (ii) Smooth; (iii) Sculpt; (iv) Lips; and (v) Eye and in Europe we obtained the rights to (i) Form; (ii) Smooth; (iii) Sculpt; and (iv) Lips.
Previous wording
•the rate of revenue growth for Jeuveau® in the United States and success of planned international launches;
Current wording
•the rate of revenue growth for Jeuveau® in the United States and international markets where we have launched, as well as the success of planned international launches;
Previous wording
•the timing of regulatory approval for the Evolysse™ dermal filler product line in the United States and Europe by Symatese and our ability to successfully commercialize these products;
Current wording
•the timing of regulatory approval for the Evolysse™ injectable hyaluronic acid gel line in the United States by Symatese and our ability to successfully launch, commercialize and market these products;
Previous wording
•development costs and milestone payments related to the Evolysse™ products;
Current wording
•development costs and milestone payments related to the Evolysse™ injectable hyaluronic acid gels;
Previous wording
•the timing and costs of any ongoing or future clinical programs we may conduct;
Current wording
•the timing and costs of any ongoing clinical programs or any future clinical studies we may conduct;
Previous wording
•the cost of commercialization activities for Jeuveau®, the Evolysse™ dermal filler product line or any future product candidates that are approved or cleared for sale, including marketing, sales and distribution costs;
Current wording
•the cost of commercialization activities for Jeuveau®, the Evolysse™ injectable hyaluronic acid gel line or any future product candidates that are approved or cleared for commercialization, including marketing, sales and distribution costs;
Previous wording
For the six months ended June 30, 2024, operating activities used $17.1 million of cash, which primarily resulted from our net loss of $24.5 million. Net operating assets and liabilities changed by $11.1 million, primarily driven by improved collections from customers, payments to vendors and the timing of inventory purchases from our supplier. Operating activities also includes adjustments for certain non-cash charges including $10.9 million of stock-based compensation expense, $3.2 million in revaluation of our contingent royalty obligation, $0.8 million of provision of allowance for doubtful accounts and $2.8 million of depreciation and amortization.
Current wording
For the nine months ended September 30, 2024, operating activities used $22.8 million of cash, which primarily resulted from our net loss of $43.6 million. Net operating assets and liabilities changed by $7.8 million, primarily driven by improved collections from customers, payments to vendors and the timing of inventory purchases from our supplier. Operating activities also includes adjustments for certain non-cash charges including $16.1 million of stock-based compensation expense, $5.6 million in revaluation of our contingent royalty obligation, $1.7 million of provision of allowance for doubtful accounts and $3.9 million of depreciation and amortization.
Previous wording
For the six months ended June 30, 2023, operating activities used $33.9 million of cash, which primarily resulted from our net loss of $32.9 million. Net operating assets and liabilities changed by $15.6 million, primarily driven by timing of receipts from customers and payments to vendors and the final cash litigation settlement payment of $5.0 million to Medytox and Allergan. Operating activities also includes adjustments for certain non-cash charges including $7.5 million of stock-based compensation expense, $3.3 million in revaluation of our contingent royalty obligation, $0.3 million of provision of allowance for doubtful accounts and $2.4 million of depreciation and amortization.
Current wording
For the nine months ended September 30, 2023, operating activities used $34.8 million of cash, which primarily resulted from our net loss of $49.9 million. Net operating assets and liabilities improved by $8.7 million, primarily driven by improved collections from customers, payments to vendors, the timing of inventory purchases from our supplier, and the final cash litigation settlement payment of $5.0 million to Medytox and Allergan. Operating activities also includes adjustments for certain non-cash charges including $12.1 million of stock-based compensation expense, $5.1 million in revaluation of our contingent royalty obligation, $1.4 million of provision of allowance for doubtful accounts and $3.8 million of depreciation and amortization.
Previous wording
Cash used in investing activities was $2.1 million for the six months ended June 30, 2024 compared to $0.7 million for the six months ended June 30, 2023.
Current wording
Cash used in investing activities was $3.5 million for the nine months ended September 30, 2024 compared to $1.3 million for the nine months ended September 30, 2023.
Previous wording
Cash provided by financing activities was $50.1 million for the six months ended June 30, 2024, compared to $22.5 million of cash provided by financing activities for the six months ended June 30, 2023. For the six months ended June 30, 2024, cash provided by financing activities resulted from $51.2 million from a follow-on equity offering as described above. For the six months ended June 30, 2023, cash provided by financing activities resulted from $25.0 million net proceeds from drawing on the second tranche of the Pharmakon Term Loans as described above.
Current wording
Cash provided by financing activities was $48.7 million for the nine months ended September 30, 2024, compared to $21.1 million of cash provided by financing activities for the nine months ended September 30, 2023. For the nine months ended September 30, 2024, cash provided by financing activities resulted from $51.2 million from a follow-on equity offering as described above. For the nine months ended September 30, 2023, cash provided by financing activities resulted from $25.0 million net proceeds from drawing on the second tranche of the Pharmakon Term Loans as described above.
Previous wording
Our material cash requirements from known contractual and other obligations, including commitments for capital expenditures, primarily consist of (i) principal and interest payments related to our Pharmakon Term Loans (future interest payments on our outstanding Pharmakon Term Loans total approximately $51.6 million, with $17.7 million due within twelve months), (ii) quarterly royalty payments to the Evolus Founders of a low single digit percentage of net sales of Jeuveau® (these obligations terminate in the quarter after the 10-year anniversary of the first commercial sale of Jeuveau® in the United States), (iii) quarterly royalty payments to Medytox of a low-double digit royalty on net sales of Jeuveau®sold in the United States and other Evolus territories (during the period from September 17, 2022 to September 16, 2032), (iv) minimum purchase obligations under the Daewoong Agreement, (v) €12.1 milestone payments under the Symatese U.S. Agreement consisting of €1.6 million in June 2025, €4.1 million in June 2026, €3.2 million in June 2027, and €3.2 million in June 2028, in each case subject to three of the dermal filler products gaining approval prior to that date, (vi) €3.1 million of milestone payments under the Symatese Europe Agreement consisting of : €1.2 million on the second anniversary of certain regulatory approvals and €1.9 million on the earlier of the third anniversary of certain regulatory approvals or following a year in which we achieves €25 million in revenue in Europe for the dermal filler products, and (vii) obligations under operating leases related to our office space which are described in more detail in Note 7. Operating Leasesin the Notes to the Condensed Consolidated Financial Statements in Part I, Item of this quarterly report. During the six months ended June 30, 2024, there were no material changes to these obligations as reported in our Annual Report on Form 10-K for the year ended December 31, 2023.
Current wording
Our material cash requirements from known contractual and other obligations, including commitments for capital expenditures, primarily consist of (i) principal and interest payments related to our Pharmakon Term Loans (future interest payments on our outstanding Pharmakon Term Loans total approximately $47.3 million, with $17.7 million due within twelve months), (ii) quarterly royalty payments to the Evolus Founders of a low-single digit percentage of net sales of Jeuveau® (these obligations terminate in the quarter after the 10-year anniversary of the first commercial sale of Jeuveau® in the United States), (iii) quarterly royalty payments to Medytox of a low-double digit royalty on net sales of Jeuveau®sold in the United States and other Evolus territories (during the period from September 17, 2022 to September 16, 2032), (iv) minimum purchase obligations under the Daewoong Agreement, (v) €12.1 milestone payments under the Symatese U.S. Agreement consisting of €1.6 million in June 2025, €4.1 million in June 2026, €3.2 million in June 2027, and €3.2 million in June 2028, in each case subject to three of the injectable hyaluronic acid gels gaining approval prior to that date, (vi) €3.1 million of milestone payments under the Symatese Europe Agreement consisting of : €1.2 million on the second anniversary of certain regulatory approvals and €1.9 million on the earlier of the third anniversary of certain regulatory approvals or following a year in which we achieves €25 million in revenue in Europe for the injectable hyaluronic acid products, and (vii) obligations under operating leases related to our office space which are described in more detail in Note 7. Operating Leasesin the Notes to the Condensed Consolidated Financial Statements in Part I, Item of this Quarterly Report on Form 10-Q. During the nine months ended September 30, 2024, there were no material changes to these obligations as reported in our Annual Report on Form 10-K for the year ended December 31, 2023.
Previous wording
We describe the recently issued and adopted accounting pronouncements that apply to us in Note 2. Summary of Significant Accounting Policies-Recent Accounting Pronouncementsin the Notes to the Condensed Consolidated Financial Statements in Part I, Item of this quarterly report.
Current wording
We describe the recently issued and adopted accounting pronouncements that apply to us in Note 2. Summary of Significant Accounting Policies-Recent Accounting Pronouncementsin the Notes to the Condensed Consolidated Financial Statements in Part I, Item of this Quarterly Report on Form 10-Q.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
In March 2024, we completed a follow-on offering and issued 3,554,000 shares of its common stock, at a price to the public of $14.07 per share. We received net proceeds of $46.8 million from the offering, after deducting underwriting discounts and commissions and other offering expenses. In addition, we granted the underwriters an option, exercisable for 30 days, to purchase up to 533,100 additional shares of common stock at the purchase price, which the underwriters exercised in April 2024 with respect to 318,100 of the allotted option shares. The net proceeds to us from the sale of the option shares, after deducting the underwriters’ discounts and commissions, was $4.2 million.
Previous report — wording carried elsewhere
For the three months ended June 30, 2023, we recorded $4.4 million of in-process research and development expense in connection with the Symatese Agreement. Refer to Note 2. Basis of Presentation and Summary of Significant Accounting Policies for additional information.