Content analysis
?Positive | ||
Negative | ||
Uncertain | ||
Constraining | ||
Legalese | ||
Litigous | ||
Readability |
H.S. sophomore Avg
|
Financial report summary
?Risks
- The COVID-19 pandemic has and may continue to, and other actual or threatened epidemics, pandemics, outbreaks, or public health crises may, adversely affect our financial condition and our business.
- We are currently, and in the future may be, subject to securities class action and stockholder derivative actions. These, and potential similar or related litigation, could result in substantial damages and may divert management’s time and attention from our business.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our Products and any future products we develop.
- We have experienced and may experience in the future compromises or failures of our information technology systems or data, or those of third parties upon which we rely, which could adversely affect our business, including but not limited to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.
- If we fail to attract and retain qualified management, clinical, scientific, technical and sales personnel, we may be unable to successfully execute our objectives.
- If we are found to have improperly promoted off-label uses for our Products that are approved for marketing, or if HCPs or injectors misuse our Products or use our Products off-label, we may become subject to prohibitions on the sale or marketing of our Products, significant fines, penalties, and sanctions, product liability claims, and our image and reputation within the industry and marketplace could be harmed.
- We generally rely on one third-party service provider for the distribution of our Products to our customers. If we experienced a sudden loss of our third-party distributor or such distributor experiences a disruption in its operations, it would affect the delivery of our Products to our customers, which could negatively impact our business, consolidated financial condition and results of operations.
- We currently contract with third-party manufacturers for certain components and services necessary to produce our products and expect to continue to do so to support further clinical trials and commercial scale production. This increases the risk that we will not have sufficient quantities of our products or be able to obtain such quantities or services at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.
- Our business involves the use of hazardous materials and we and our third-party manufacturers and suppliers must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
- Clinical drug development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
- If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed.
- We may become involved in lawsuits or administrative proceedings to protect or enforce our patents or other intellectual property or the patents of our licensors, or to challenge patent claims of third party patents which could be expensive and time-consuming.
- We may not be able to protect our intellectual property rights throughout the world.
- Our business and Products are subject to extensive government regulation.
- Our Products remain subject to ongoing regulatory obligations and continued regulatory oversight even though approved, which may result in significant additional expense, may limit or delay additional regulatory approvals, may subject us to penalties, and may result in withdrawal of regulatory approval if we fail to comply with applicable regulatory requirements.
- We are subject to stringent and changing obligations related to data privacy and security. Our actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions, litigation, fines and penalties, disruptions of our business operations, reputational harm, loss of revenue or profits, loss of customers or sales and other adverse business consequences.
- Our Products and any future approved products may cause or contribute to adverse medical events that we are required to report to regulatory agencies and if we fail to do so, we could be subject to sanctions that would materially harm our business.
- The terms of the Note Purchase Agreement place restrictions on our operating and financial flexibility, and if we fail to comply with these restrictions, our business, business prospects, results of operations and financial condition may be adversely affected.
- We may not have the ability to raise the funds necessary to settle conversions of the 2027 Notes in cash or to repurchase the 2027 Notes upon a fundamental change, and our future debt may contain limitations on our ability to pay cash upon conversion or repurchase of the 2027 Notes.
- The conditional conversion feature of the 2027 Notes, if triggered, may adversely affect our financial condition and operating results.
- Conversion of the 2027 Notes may dilute the ownership interest of our stockholders or may otherwise depress the price of our common stock.
- The trading price of our common stock is volatile, and purchasers of our common stock could incur substantial losses.
- If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline.
- Sales of substantial amounts of our common stock in the public markets, or the perception that such sales might occur, could cause the market price of our common stock to drop significantly, even if our business is doing well.
- Provisions in our corporate charter documents and under Delaware law could discourage takeover attempts and lead to management entrenchment, and the market price of our common stock may be lower as a result.
- Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful third-party claims against us and may reduce the amount of money available to us.
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains.
Management Discussion
- A discussion regarding our financial condition and results of operations for the year ended December 31, 2023 compared to the same period in 2022 is presented below. For a discussion regarding our financial condition and results of operations for the year ended December 31, 2022 compared to the same period in 2021, see Part II, Item 7. “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Results of Operations” of our FY 2022 Annual Report.
- We started to generate product revenue from DAXXIFY® in the fourth quarter of 2022 from the pre-launch promotional PrevU program for select practice partners. We completed the PrevU program in March 2023, which was followed by the targeted commercial launch of DAXXIFY®. Based on real-world learnings and customer feedback, in September 2023 we introduced a new pricing for DAXXIFY® which reduced our average selling price. During the three months ended December 31, 2023, product revenue from DAXXIFY® increased by 9% as volume sold increased by 22% compared to the three months ended September 30, 2023, offset by a lower average selling price resulting from the new pricing strategy discussed above.
- For the year ended December 31, 2023, our product revenue from the sale of DAXXIFY® increased compared to the same period in 2022 primarily due to the full year of DAXXIFY® sales in 2023 compared to a partial year of DAXXIFY® sales in 2022. For the year ended December 31, 2023, our product revenue from the sale of the RHA® Collection of dermal fillers increased compared to the same period in 2022 primarily due to an increase in units of the RHA® Collection of dermal fillers sold.