The information in this Item 7.01, including Exhibits 99.1 and 99.2 hereto, is furnished pursuant to Item 7.01 and 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 in any filing under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, except as expressly set forth by specific reference in such a filing. The Company’s submission of this Report shall not be deemed an admission as to the materiality of any information required to be disclosed solely to satisfy the requirements of Regulation FD.
Forward-Looking Statements
This Report and Exhibits 99.1 and 99.2 hereto contain forward-looking statements within the meaning of the federal securities laws.
Any statements in this Report and Exhibits 99.1 and 99.2 that are not statements of historical fact, including statements related to our 2023 guidance and guidance plans; our anticipated adjusted gross margins; our funding to cash flow breakeven; our capital requirements; the timing for reaching positive adjusted EBITDA; projected loss from the services segment; anticipated restructuring and impairment charges; the plans for the OPUL® business and anticipated cash to be freed up from the exit of the OPUL® payments business; our ability to successfully commercialize DAXXIFY®, drive adoption, take market share and grow; our blockbuster potential; DAXXIFY® cervical dystonia launch; our market opportunity, market growth and market resiliency; our therapeutics pipeline expansion; our potential to disrupt the market; our contract manufacturer plans; potential product margins; future innovations; injector, consumer and payer expectations, preferences and behavior; the impact of DAXXIFY® pricing on injectors, consumers and payers; our ability to deliver loyalty and practice partnership solutions; the potential benefits and performance of our products; the efficacy, duration and safety of DAXXIFY®; symptom reemergence in cervical dystonia patients; reimbursement expectations; our ability to optimize patient outcomes and practice integration; the infrastructure and key milestones related to DAXXIFY® for the treatment of cervical dystonia; the commercialization of DAXXIFY® through our Fosun partnership; anticipated approvals; international expansion; development of a biosimilar to onabotulinumtoxinA for injection with Viatris; our partnerships; and our business and marketing strategy, timeline and other goals, and plans and prospects, including our commercialization plans; constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act and Section 21E of the Exchange Act. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results and the timing of events to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, revenues, capital requirements, our financial performance and the economics of DAXXIFY® and the RHA® Collection of dermal fillers; the extent of future impairment charges; our ability to comply with our debt obligations; the impact of macroeconomic factors on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability to maintain approval of our products; our ability and the ability of our partners to manufacture supplies for DAXXIFY® and our drug product candidates; our ability to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates and third-party manufacturers; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY®, the RHA® Collection of dermal fillers, and our drug product candidates, if approved; our ability to successfully commercialize DAXXIFY® and to continue to successfully commercialize the RHA® Collection of dermal fillers; the timing and cost of commercialization activities; securing or maintaining adequate coverage or reimbursement by third-party payors for DAXXIFY®; the proper training and administration of our products by physicians and medical staff; our ability to gain acceptance from physicians in the use of DAXXIFY® for therapeutic indications; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with laws and regulations; our ability to continue obtaining and maintaining intellectual property protection for our products; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; our ability to limit or mitigate cybersecurity incidents; the volatility of our
