Institutional Analyst: Our #1 Internet Company, Society Pass (Nasdaq: SOPA), Holds Appeal for Both Traders and Long-Term Investors

New York, NY, Feb. 28, 2023 (GLOBE NEWSWIRE) — via NewMediaWire — Institutional Analyst Inc (“Institutional Analyst”) issues Equity Research Report on Society Pass Incorporated (“SoPa”) (Nasdaq: SOPA), Southeast Asia’s (SEA) next generation, data-driven, loyalty, fintech and e-commerce ecosystem.

Click here to view the full Institutional Analyst Equity Research Report.

Summary Points:

Compelling investment thesis – With near $20 million of cash in the bank, versus a $28 million current market capitalization, and with four Wall Street firms price targets averaging $6.60 (500% higher) and their revenue projections ranging from $40 to $60 million in 2023, SoPa can only be defined as compelling.

SoPa is building a portfolio of eCommerce start-ups and has all the ingredients in a major winner:
·      Easy to Understand Business Model
·      Underfollowed
·      Scaleable Sector, Offering 100X Growth Potential
·      Offers US Investors Back Door Entry Into Fast Growing SE Asia
·      Market Capitalization Under $500 Million
·      Financially Sound
·      Management Team With Both Financial and eCommerce Expertise
·      Summary and How to Trade and Invest in SOPA
·      Wall Street Coverge

Sustainable incubator business model – While still early (bottom of the first inning), the Society Pass business model is off to an excellent start, with six acquisitions last year alone. Institutional Analyst views incubators and accelerators as having the most ‘durable’ model of any in the technology sector, in that they are on a constant search for early-stage companies that are creating the latest and most innovative technologies or services.

Underfollowed – At $1.00 currently, Society Pass has a market value of $28 million with only 28 million shares outstanding. While we consider Society Pass to be under-followed, by no means is it un-followed. There are four Wall Street firms that have initiated coverage with lengthy research reports, totaling over 70 pages, including this report. With price targets averaging $6.60 or better than 500% higher than where it is currently trading, we could have headlined this section, “Loved But Under-followed”.

Easy to Understand Game Plan – SoPa doesn’t buy and fix. It buys or partners, and then supercharges or scales early technology start-ups.  Led by former investment banker Dennis Nguyen, SOPA looks for visionary founders with three to four years of experience under their belt. Companies that may be growing at 50-70% a year. These are not companies needing to be fixed. Investing in SoPa is very much like investing in the experienced manager of a venture capital firm. Not investing in the venture capital fund – but in the experienced manager of the fund. This is where the Society Pass business attractiveness comes in. There are hundreds of viable acquisition candidates in SE Asia and any single one has the potential to be the next Tik-Tok (Tik-Tok after all didn’t know it was going to be the next Tik-Tok, when it was started in a three-bedroom apartment).

Scaleable Sector Offering 100X Growth Potential – There are very few limitations to the scalabilty of the Society Pass business plan. They need analysts and deal-makers to bring the acquisition targets under the SOPA umbrella. And they need to ensure the acquired companies understand the benefits of integrating with SOPA’s Loyalty program called ‘Society Points’, a digital wallet, and a defacto currency. It will tie all of its acquired companies together, enabling data integration (who’s buying what) leading to enhancing revenues for all its controlled properties and outlets. They’re not looking to grow this operation to 10x or 20x. They’re looking to expand this 100-fold.

Offers US Investors Back Door Entry Into Fast Growing SE Asia – Investing in Society Pass offers US investors a back door entry into these fast-growing start-ups, with considerably less risk, as we can rely on an experienced management team to do all the hard work for us. The CEO is an entrepreneur who has taken six companies public. As a former investment banker, he can identify thousands and acquire scores of start-ups. We believe he is well-suited to guide us through a maze of opportunities.

Deep Management Team With Both Financial and eCommerce Expertise – The company is run by a deep bench of C-suite executives, country managers and business unit heads.

About Society Pass Inc.

Founded in 2018 as a data-driven loyalty, fintech and e-commerce ecosystem in the fast-growing markets of Vietnam, Indonesia, Philippines, Singapore and Thailand, which account for more than 80% of the SEA population, and with offices located in Angeles, Bangkok, Ho Chi Minh City, Jakarta, Manila, and Singapore, Society Pass Incorporated (Nasdaq: SOPA) is an acquisition-focused holding company operating 6 interconnected verticals (loyalty, digital media, travel, telecoms, lifestyle, and F&B), which seamlessly connects millions of registered consumers and hundreds of thousands of registered merchants/brands across multiple product and service categories throughout SEA.

Society Pass completed an initial public offering and began trading on the Nasdaq under the ticker SOPA in November 2021. SOPA shares were added to the Russell 2000 index in December 2021.

SoPa acquires fast growing e-commerce companies and expands its user base across a robust product and service ecosystem. SoPa integrates these complementary businesses through its signature Society Pass fintech platform and circulation of its universal loyalty points or Society Points, which has entered beta testing and is expected to launch broadly at the beginning of 2023. Society Pass loyalty program members earn and redeem Society Points and receive personalised promotions based on SoPa’s data capabilities and understanding of consumer shopping behaviour. SoPa has amassed more than 3.3 million registered consumers and over 205,000 registered merchants and brands. It has invested 2+ years building proprietary IT architecture to effectively scale and support its consumers, merchants, and acquisitions.

Society Pass leverages technology to tailor a more personalised experience for customers in the purchase journey and to transform the entire retail value chain in SEA. SoPa operates Thoughtful Media Group, a Thailand-based, a social commerce-focused, premium digital video multi-platform network; NusaTrip, a leading Indonesia-based Online Travel Agency; Gorilla Networks, a Singapore-based, web3-enabled mobile blockchain network operator; Leflair.com, Vietnam’s leading lifestyle e-commerce platform; Pushkart.ph, a popular grocery delivery company in Philippines; Handycart.vn, a leading online restaurant delivery service based in Vietnam; and Mangan.ph, a leading local restaurant delivery service in Philippines.

For more information on Society Pass, please visit:

Website at https://www.thesocietypass.com or

LinkedIn at https://www.linkedin.com/company/societypass  or

Facebook at https://www.facebook.com/thesocietypass  or

Twitter at https://twitter.com/society_pass or

Instagram at https://www.instagram.com/societypass/.

Cautionary Note Concerning Forward-Looking Statements

This press release may include “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact included in this press release are forward-looking statements. When used in this press release, words such as “anticipate”, “believe”, “estimate”, “expect”, “intend” and similar expressions, as they relate to us or our management team, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, the Company’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in the Company’s filings with the SEC. All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and prospectus relating to the Company’s initial public offering filed with the SEC. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Media Contacts:

PRecious Communications
[email protected]



Bioventus Enters into Settlement Agreement to Preserve Maximum Optionality – Up To $350mm of Potential Liability Reduction and a Release of Future Claims related to the CartiHeal Acquisition

DURHAM, N.C., Feb. 28, 2023 (GLOBE NEWSWIRE) — Bioventus Inc. (Nasdaq: BVS) (“Bioventus” or the “Company”), a global leader in innovations for active healing, announced today that it has entered into a Settlement Agreement (the “Settlement Agreement”) with the former CartiHeal shareholders (the “CartiHeal Sellers”) regarding the Company’s obligations under the amended Option and Equity Purchase Agreement for its prior acquisition of CartiHeal (the “Amended Acquisition Agreement”).

The Settlement Agreement provides the Company with the option to eliminate the entirety of $350 million of deferred purchase price obligations plus accrued interest under the Amended Acquisition Agreement (which is comprised of $215 million of Post-Closing Tranches and a $135 million Sales Milestone payment, if applicable, each as defined in the Amended Acquisition Agreement, plus any applicable interest). The Settlement Agreement also releases the Company from any and all future claims or obligations by or to the CartiHeal Sellers that may have arisen under the Amended Acquisition Agreement.

The Company has been granted a 30-day period in which it may evaluate options to fund the remaining obligations under the Amended Acquisition Agreement in order to retain CartiHeal. Funding options will only be pursued by the Company on an opportunistic basis, on terms that the Company believes would be favorable to its stakeholders. If the Company does not obtain funding sufficient to satisfy the $215 million of Post-Closing Tranche obligations, plus any applicable interest, under the Amended Purchase Agreement by the expiration of the 30-day period, the Company has agreed to transfer ownership of CartiHeal to the CartiHeal Sellers. In addition, during the 30-day period, the CartiHeal shares have been transferred to a trust for the benefit of the CartiHeal Sellers.

In exchange for the release of the Company’s obligations and the 30-day period, the Company agreed to pay the CartiHeal Sellers $10,000,000 in cash as well as $150,000 in a non-refundable expense reimbursement payment. The Company will also have the option to exercise up to two extension periods of 15 days each in exchange for an additional $5,000,000 payment per extension.

About Bioventus

Bioventus delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The Innovations for Active Healing from Bioventus include offerings for Pain Treatments, Restorative Therapies and Surgical Solutions. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.bioventus.com, and follow the Company on LinkedIn and Twitter. Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, expectations as to future payment obligations to the CartiHeal Sellers and any plans to obtain funding sufficient to satisfy the $215 million of Post-Closing Tranche obligations, plus any applicable interest, during the 30-day period. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause the Company’s actual results to differ materially from those contemplated in this press release include, but are not limited to, the Company’s ability to secure additional funding, if needed, on reasonable terms or at all; risks related to its debt and future capital needs; its ability to meet certain of its debt covenants under its Credit Agreement and the potential accelerated obligation to repay indebtedness; its ability to complete acquisitions or successfully integrate new businesses in a cost-effective and non-disruptive manner; its ability to continue to fund operations for at least the next twelve months as a going concern; and the other risks identified in the Risk Factors section of the Company’s public filings with the Securities and Exchange Commission (SEC), including Bioventus’ Annual Report on Form 10-K for the year ended December 31, 2021, as updated by Bioventus’ subsequent Quarterly Report on Form 10-Q for the quarter ended October 1, 2022 and as may be further updated from time to time in Bioventus’ other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at https://ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.

Investor and Media Inquiries:

Dave Crawford
919-474-6787
[email protected]



XOMA to Present at 43rd Annual Cowen Health Care Conference

EMERYVILLE, Calif., Feb. 28, 2023 (GLOBE NEWSWIRE) — XOMA Corporation (NASDAQ: XOMA), the Biotech Royalty Aggregator, announced today that Owen Hughes, Executive Chairman, and Brad Sitko, Chief Investment Officer, will be featured in a fireside chat at the 43rd Annual Cowen Health Care Conference on Tuesday, March 7, 2023, at 2:10 PM ET.

The presentation can be accessed at https://bit.ly/3DmxDFH or by visiting the investor relations section of the Company’s website at www.xoma.com.  A replay of the presentation will be available and archived on the site for 90 days after the event.

About XOMA Corporation

XOMA is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health.  XOMA acquires the potential future economics associated with pre-commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies.  When XOMA acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes.  The Company has an extensive and growing portfolio with more than 70 assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate).  For more information about the Company and its portfolio, please visit www.xoma.com.

EXPLANATORY NOTE:

Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development.  Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.  As of the date of this press release, all assets in XOMA’s milestone and royalty portfolio, except Vabysmo® (faricimab), are investigational compounds.  Efficacy and safety have not been established.  There is no guarantee that any of the investigational compounds will become commercially available.

XOMA Investor Contact
XOMA Media Contact
Juliane Snowden Kathy Vincent
XOMA Corporation KV Consulting & Management
+1 646-438-9754 +1 310-403-8951
[email protected] [email protected]



TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2022 Financial Results

Conference call to be held today, Tuesday, February 28, 2023, at 8:30 AM ET

NEW YORK, Feb. 28, 2023 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX) today announced its financial results for the fourth quarter and year ended December 31, 2022, and recent company developments.

Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, stated, “2022 was a pivotal year for TG with the approval of BRIUMVI for relapsing forms of Multiple Sclerosis, and 2023 is off to an exciting start with the commercial launch of BRIUMVI. Our teams are hard at work introducing BRIUMVI to the MS community and while we are only 4 weeks into the launch, we are encouraged by the early feedback from providers, payors and advocates.” Mr. Weiss continued, “Our highest priority is our commitment to patients and to ensure that patients who want BRIUMVI will have access to BRIUMVI. We look forward to building on the foundation we are developing in this early launch phase and extending it throughout 2023 and beyond.”


202


2


Highlights & Recent Development


s

  • U.S. Food and Drug Administration (FDA) approved BRIUMVI™ (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Commercially launched BRIUMVI making it available for patients and physicians.
  • Presented additional data, including new analyses, from the ULTIMATE I and II Phase 3 trials at the 2022 Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and at the 2023 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) annual forum.


Key Objectives for


202


3

  • Execute a strong commercial launch of BRIUMVI in RMS
  • Obtain broad payor coverage for BRIUMVI
  • Continue to present additional data from the ULTIMATE I & II Phase 3 trials of BRIUMVI in RMS


Financial Results for the Fourth Quarter and Full Year 202


2

  • Product Revenue, net: Product revenue, net was approximately zero and $2.6 million for the three and twelve months ended December 31, 2022. Net product revenues during the year represent U.S. sales of UKONIQ, which received approval in February of 2021 and was withdrawn from the U.S. market effective May 31, 2022.
  • R&D Expenses: Total research and development (R&D) expense was $29.6 million and $125.4 million for the three and twelve months ended December 31, 2022, compared to $62.6 million and $222.6 million for the three and twelve months ended December 31, 2021. The decrease in R&D expense is primarily attributable to reduced clinical trial related expenses, license milestones and manufacturing expense, decreased headcount and lower fees paid to consultants and outside service providers, as well as a decrease in non-cash compensation R&D expense during the twelve months ended December 31, 2022 over the comparable period in 2021.
  • SG&A Expenses: Total selling, general and administrative (SG&A) expense was $22.5 million and $70.0 million for the three and twelve months ended December 31, 2022, and $32.4 million and $128.1 million for the three and twelve months ended December 31, 2021. The decrease was primarily attributable to reduced other selling, general and administrative costs as a result of our withdrawal of UKONIQ and decreased headcount during the period ended December 31, 2022, as well as decreased non-cash compensation G&A expense during the twelve months ended December 31, 2022 over the comparable period in 2021.
  • Net Loss: Net loss was $53.0 million and $198.3 million for the three and twelve months ended December 31, 2022, compared to $93.3 million and $348.1 million for the three and twelve months ended December 31, 2021. Excluding non-cash compensation, the net loss for the three and twelve months ended December 31, 2022 was approximately $41.9 million and $179.2 million, compared to a net loss of $79.0 million and $286.8 million for the three and twelve months ended December 31, 2021.
  • Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $174.1 million as of December 31, 2022. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2022, combined with the $45.0 million of available capacity under our existing term loan facility and projected revenues, will be sufficient to fund the Company’s planned operations into mid-2024.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, February 28, 2023, at 8:30 AM ET, to discuss the Company’s fourth quarter and year-end 2022 financial results.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

ABOUT BRIUMVI™ (ublituximab-
xiiy
) 150 mg/6 mL Injection for IV

BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.

BRIUMVI is indicated for the treatment of adults with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

A list of authorized specialty distributors can be found at www.briumvi.com.

IMPORTANT SAFETY INFORMATION

Contraindications: BRIUMVI is contraindicated in patients with:

  • Active HBV infection
  • A history of life-threatening infusion reaction to BRIUMVI

WARNINGS AND PRECAUTIONS

Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was 48%, with the highest incidence within 24 hours of the first infusion. 0.6% of BRIUMVI-treated patients experienced infusion reactions that were serious, some requiring hospitalization.

Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was 56% compared to 54% in teriflunomide-treated patients. The rate of serious infections was 5% compared to 3% respectively. There were 3 infection-related deaths in BRIUMVI-treated patients. The most common infections in BRIUMVI-treated patients included upper respiratory tract infection (45%) and urinary tract infection (10%). Delay BRIUMVI administration in patients with an active infection until the infection is resolved.

Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.


Hepatitis B Virus (HBV) Reactivation:
HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for surface antigen [HBsAg] and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.


Progressive Multifocal Leukoencephalopathy (PML):
Although no cases of PML have occurred in BRIUMVI-treated MS patients, JCV infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.

If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.

If PML is confirmed, treatment with BRIUMVI should be discontinued.


Vaccinations:
Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines at least 4 weeks and, whenever possible at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.


Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy:
In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.

Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.

Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in 0.6% of BRIUMVI-treated patients compared to none of the patients treated with teriflunomide in RMS clinical trials. Monitor the levels of quantitative serum immunoglobulins during treatment, especially in patients with opportunistic or recurrent infections, and after discontinuation of therapy until B-cell repletion. Consider discontinuing BRIUMVI therapy if a patient with low immunoglobulins develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least 10%) were infusion reactions and upper respiratory tract infections.

Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.

ABOUT BRIUMVI PATIENT SUPPORT

BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.

ABOUT MULTIPLE SCLEROSIS

Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately 85% are initially diagnosed with RRMS.1,2 The majority of people who are diagnosed with RRMS will eventually transition to SPMS, in which they experience steadily worsening disability over time. Worldwide, more than 2.3 million people have a diagnosis of MS.1

ABOUT TG THERAPEUTICS

TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received approval from the U.S. FDA for BRIUMVI™ (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. For more information, visit www.tgtherapeutics.com, and follow us on Twitter @TGTherapeutics and on LinkedIn.

Cautionary Statement

This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.

Such forward looking statements include but are not limited to statements regarding expectations for the timing and success of our commercial launch and availability of BRIUMVI™ (ublituximab-xiiy) for relapsing forms of multiple sclerosis (RMS); anticipated healthcare professional and patient acceptance and use of BRIUMVI for the FDA-approved indications, and statements regarding the results of the ULTIMATE I & II Phase 3 studies and BRIUMVI as a potential treatment for RMS.

Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to establish and maintain a commercial infrastructure for BRIUMVI, and to successfully or in the timeframe projected, launch, market and sell BRIUMVI; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variation from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; potential regulatory challenges to the Company’s plans to seek marketing approval for the product in jurisdictions outside of the U.S.; the uncertainties inherent in research and development; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; and general political, economic and business conditions, including the risk that the ongoing COVID-19 pandemic could have on the safety profile of BRIUMVI and any of our other drug candidates as well as any government control measures associated with COVID-19 that could have an adverse impact on our research and development plans or commercialization efforts. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in our other filings with the U.S. Securities and Exchange Commission.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:  
  Investor Relations
  Email: [email protected]
  Telephone: 1.877.575.TGTX (8489), Option 4
   
  Media Relations:
  Email: [email protected]
  Telephone: 1.877.575.TGTX (8489), Option 6


1.

 MS Prevalence. National Multiple Sclerosis Society website. 

https://www.nationalmssociety.org/About-the-Society/MS-Prevalence

. Accessed October 26, 2020.

 2.

 Multiple Sclerosis International Federation, 2013 via 
Datamonitor
 p. 236.

TG Therapeutics, Inc.

Selected Condensed Consolidated Financial Data

Statements of Operations Information (in thousands, except share and per share amounts; unaudited)
:

  Three months ended
December 31,



 


Year ended
December 31,
   2022   2021     2022  2021
Revenues:          
Product revenue, net $42   $2,283     $2,633   $6,537  
License revenue 38   38     152   152  
Total revenue 80   2,321     2,785   6,689  
                   
Costs and expenses:                  
Cost of product revenue 3   210     265   790  
Research and development:                  
Noncash compensation 5,753   4,986     13,224   24,047  
Other research and development 23,882   57,660     112,128   198,532  
Total research and development 29,635   62,646     125,352   222,579  
                   
Selling, General and administrative:                  
Noncash compensation 5,298   9,370     5,961   37,227  
Other selling, general and administrative 17,206   23,042     64,046   90,863  
Total selling, general and administrative 22,504   32,412     70,007   128,090  
                   
Total costs and expenses 52,142   95,268     195,624   351,459  
                   
Operating loss (52,062 ) (92,947 )   (192,839 ) (344,770 )
                   
Other expense (income):                  
Interest expense 2,862   1,079     10,191   5,638  
Other expense (income) (1,930 ) (688 )   (4,695 ) (2,307 )
Total other expense, net 932   391     5,496   3,331  
                   
Net loss $(52,994 ) $(93,338 )   $(198,335 ) $(348,101 )
                   
Basic and diluted net loss per common share $(0.39 ) $(0.70 )   $(1.46 ) $(2.63 )
                   
Weighted average shares used in computing basic and diluted net loss per common share 137,108,759   132,557,597     135,411,258   132,222,753  
                   

Condensed Balance Sheet Information (in thousands):

  December 31, 202
2

(Unaudited)
  December 31, 202
1
*
 
Cash, cash equivalents and investment securities $174,082   350,296  
Total assets 193,572   379,629  
Accumulated deficit (1,527,033 ) (1,328,698 )
Total equity 58,587   237,153  

    * Condensed from audited financial statements



Johnson Financial Group Selects nCino to Modernize Multiple Lines of Business

Midwest community bank moves to single platform to help ensure customer experience is at the forefront of every interaction

WILMINGTON, N.C., Feb. 28, 2023 (GLOBE NEWSWIRE) — nCino, Inc. (NASDAQ: NCNO), a pioneer in cloud banking for the global financial services industry, today announced that Johnson Financial Group (JFG), a privately-held financial services company and registered investment advisor, will be using nCino’s cloud banking platform across multiple lines of business, including Commercial, Small Business, Retail and Deposit Account Openings. JFG will also be adding nCino solutions for Commercial Pricing and Profitability, as well as Auto Spreading to further harness the advantage of a single platform. nCino’s customizable platform will help JFG modernize its front, middle and back offices and successfully put the customer at the center of every interaction to ensure they have complete insight into their loan status at any point in the cycle.

“Our institution is built on trust, integrity, and a deep focus on providing the best-in-class financial service for our clients,” said Dan Defnet, EVP – President, Johnson Bank. “As Wisconsin’s largest family-owned financial services company, we provide our clients with solutions that will help them thrive throughout their financial journey. nCino will be a catalyst in that journey across every aspect of our bank.”

With more than $6 billion in assets, JFG has been serving the families and clients of Wisconsin and Minnesota for more than 50 years. By selecting every solution on the nCino platform, JFG will add extensive value for their clients’ financial needs, eliminating siloed transformation, due to outdated legacy disparate systems, creating one open, single ecosystem.

“JFG is not only putting their client’s experience at the center of everything, but they are making forward looking change that can provide the very best experiences for every family that uses its services,” said nCino’s SVP of Community and Regional Banking Will Cameron. “JFG is laying the groundwork for a scalable and sustainable technological foundation, which will empower it further in providing its clients what they need, while still upholding its commitment to personal service and attention. We’re incredibly proud to be working with JFG and eager to see the value that the nCino platform will bring.” 

About nCino

nCino (NASDAQ: NCNO) is the worldwide leader in cloud banking. The nCino Bank Operating System® empowers financial institutions with scalable technology to help them achieve revenue growth, greater efficiency, cost savings and regulatory compliance. In a digital-first world, nCino’s single cloud-based platform enhances the employee and client experience to enable financial institutions to more effectively onboard clients, make loans and manage the entire loan life cycle, and open deposit and other accounts across lines of business and channels. Transforming how financial institutions operate through innovation, reputation and speed, nCino is partnered with more than 1,750 financial institutions of all types and sizes on a global basis. For more information, visit www.ncino.com.

About Johnson Financial Group

Johnson Financial Group is a Wisconsin-based, privately-owned financial services company offering banking, wealth and insurance solutions through its subsidiaries, Johnson Bank, Johnson Wealth, and Johnson Insurance Services. Principal owners of Johnson Financial Group are members of the Samuel C. Johnson family. Helen Johnson-Leipold is Chairman of Johnson Financial Group. For more information visit www.johnsonfinancialgroup.com.


Media Contacts


Ryan Kelly
+1 732.770.5942
[email protected]

This press release contains forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally include actions, events, results, strategies and expectations and are often identifiable by use of the words “believes,” “expects,” “intends,” “anticipates,” “plans,” “seeks,” “estimates,” “projects,” “may,” “will,” “could,” “might,” or “continues” or similar expressions. Any forward-looking statements contained in this press release are based upon nCino’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent nCino’s expectations as of the date of this press release. Subsequent events may cause these expectations to change and, except as may be required by law, nCino does not undertake any obligation to update or revise these forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially including, among others, risks and uncertainties relating to the market adoption of our solution and privacy and data security matters. Additional risks and uncertainties that could affect nCino’s business and financial results are included in reports filed by nCino with the U.S. Securities and Exchange Commission (available on our web site at www.ncino.com or the SEC’s web site at www.sec.gov). Further information on potential risks that could affect actual results will be included in other filings nCino makes with the SEC from time to time.



BeautyHealth Reports Full Year and Fourth Quarter 2022 Financial Results

BeautyHealth Reports Full Year and Fourth Quarter 2022 Financial Results

  • Delivers +41% year-over-year topline growth for the year and exceeds market expectations for eighth consecutive quarter
  • Increases adjusted EBITDA +46% year-over-year, landing within guided annual range
  • Sets 2023 profitable growth targets on strategy to increase operating leverage and accelerate in China, confirms long-range 2025 guidance

LONG BEACH, Calif.–(BUSINESS WIRE)–
The Beauty Health Company (NASDAQ: SKIN), home to flagship brand Hydrafacial, today announced financial results for the full year and fourth quarter ended December 31, 2022. Full year 2022 net sales of $365.9 million increased +41% relative to 2021, and fourth quarter net sales of $98.1 million increased +26%, revealing consistent mid-to-high double-digit quarterly growth year-over-year.

The Company delivered net income of $44.4 million and adjusted EBITDA of $47.7 million for the full year, up +46% relative to 2021, and net income of $3.8 million and adjusted EBITDA of $16.3 million for the fourth quarter, up +92% relative to the fourth quarter of 2021. Fiscal year 2022 adjusted EBITDA was within the previously guided $45 million to $50 million range, despite a slower than expected reopening and delayed return on planned investment in China.

On continued momentum and demand for its differentiated offering, BeautyHealth expects 2023 net sales of $450 million to $470 million, and affirms its 2023 18% to 20% adjusted EBITDA margin target. BeautyHealth also confirms its long-range 2025 guidance of $600 million to $700 million in net sales and 25% to 30% adjusted EBITDA margin introduced during its Investor Day in September 2022.

“I am proud of the significant progress our team made this year. We achieved strong annual sales growth, launched Hydrafacial Syndeo, our innovative next generation delivery system, and continued to build the world’s premiere skincare booster portfolio,” said BeautyHealth President and Chief Executive Officer Andrew Stanleick. “We enter 2023 from a position of strength, having invested to expand our global capabilities and scale. As planned, we are now turning our focus to driving profitable growth and flawlessly executing our international Syndeo launch in the second quarter.”

Full Year 2022 Summary

  • Global performance:

    • Record global net sales of $365.9 million, +41% relative to 2021
    • $250.3 million and $267.2 million gross margin and adjusted gross margin, respectively, resulting in a 149bps and 103bps year-over-year decline in gross margin and adjusted gross margin, respectively. The decline was primarily driven by trade-up volumes, premiums paid on accelerated manufacturing and shipping associated with Syndeo’s US launch and international launch readiness, global supply chain challenges, inflationary pressures and foreign exchange headwinds
    • Net income and adjusted net income of $44.4 million and $9.1 million, respectively, compared to net loss and adjusted net income of ($375.1) million and $4.5 million in 2021, respectively
    • Adjusted EBITDA of $47.7 million, +46% relative to 2021 despite China’s zero-Covid policy and foreign exchange headwinds encountered during the year
  • Double digit net sales growth across all regions:

    • Americas: $243.2 million, +44% year-over-year, fueled by strong Syndeo performance and continued conquest of new providers
    • APAC: $54.3 million, +24% year-over-year, even with the prolonged impact of China’s zero-Covid policy and lagging consumer mobility
    • EMEA: $68.3 million, +46% year-over-year, despite foreign exchange headwinds
  • Record single-year delivery system sales:

    • 8,492 delivery systems sold, including 1,793 trade-ups, representing +37% delivery systems volume growth compared to 2021
    • Total net global delivery system install base of 25,336 systems as of December 31, 2022
  • Key strategic initiatives:

    • Introduction of Syndeo, the revolutionary next generation, digitally connected Hydrafacial delivery system
    • Driving consumables growth with an active R&D pipeline of co-created boosters, including launches with JLO Beauty, Murad Skincare, Dr. BABOR Skincare and Glytone
    • Significant global expansion and infrastructure investments made in system implementation, value engineering efforts, global commercial infrastructure, senior talent and readying production in China

Key Operational and Business Metrics

 

Three Months Ended December 31,

 

Year Ended December 31,

Unaudited (dollars in millions)

2022

 

2021

 

2022

 

2021

Delivery Systems net sales

$

50.7

 

 

$

42.7

 

 

$

206.2

 

 

$

139.5

 

Consumables net sales

 

47.4

 

 

 

35.2

 

 

 

159.6

 

 

 

120.6

 

Total net sales

$

98.1

 

 

$

77.9

 

 

$

365.9

 

 

$

260.1

 

Gross profit

$

65.2

 

 

$

56.8

 

 

$

250.3

 

 

$

181.8

 

Gross margin

 

66.4

%

 

 

72.9

%

 

 

68.4

%

 

 

69.9

%

Net income (loss)

$

3.8

 

 

$

(17.3

)

 

$

44.4

 

 

$

(375.1

)

Adjusted net income (loss)*

$

7.4

 

 

$

1.6

 

 

$

9.1

 

 

$

4.5

 

Adjusted EBITDA*

$

16.3

 

 

$

8.5

 

 

$

47.7

 

 

$

32.7

 

Adjusted EBITDA margin*

 

16.6

%

 

 

10.9

%

 

 

13.0

%

 

 

12.6

%

Adjusted gross profit*

$

70.9

 

 

$

59.6

 

 

$

267.2

 

 

$

192.6

 

Adjusted gross margin*

 

72.3

%

 

 

76.5

%

 

 

73.0

%

 

 

74.1

%

*See “Non-GAAP Financial Measures” below.

Fourth Quarter 2022 Summary

  • Net sales of $98.1 million increased +26% in Q4 2022 compared to $77.9 million in Q4 2021, driven by strength across delivery systems and consumables

    • Delivery Systems net sales increased +19% to $50.7 million in Q4 2022 compared to Q4 2021. The Company sold 2,067 Delivery Systems during the quarter
    • Consumables net sales increased +35% to $47.4 million in Q4 2022 compared to Q4 2021
    • Net sales in the Americas region increased +29% to $64.9 million in Q4 2022 compared to Q4 2021, driven by strength in Syndeo placements and the expansion to new providers
    • Net sales in the APAC region increased +33% to $15.9 million in Q4 2022 compared to Q4 2021, despite the impact of China’s zero-Covid policy and lagging consumer mobility in China
    • Despite foreign exchange rate headwinds, net sales in the EMEA region increased +12% to $17.3 million in Q4 2022 compared to Q4 2021, driven by strong performance across the region
  • Gross margin was 66.4% in Q4 2022 compared to 72.9% in Q4 2021, and adjusted gross margin was 72.3% in Q4 2022 compared to 76.5% in Q4 2021, with the changes due to costs associated with Syndeo’s US launch and international launch readiness (including trade-up volumes and premiums paid on accelerated manufacturing and shipping), global supply chain challenges, inflationary pressures and foreign exchange headwinds
  • Selling and marketing expenses were $39.0 million in Q4 2022 compared to $37.1 million in Q4 2021, primarily driven by increases in sales commissions associated with higher revenues partially offset by leverage of fixed marketing investment
  • Operating loss was $3.8 million in Q4 2022 compared to an operating loss of $7.2 million in Q4 2021, primarily due to increased revenue from higher volumes of delivery systems and consumables sold. The operating loss in Q4 2022 includes approximately $2.8 million in patent litigation expenses and approximately $2.4 million in non-recurring Syndeo initial program logistics and services costs
  • Net income was $3.8 million in Q4 2022 compared to a net loss of $17.3 million in Q4 2021, and adjusted net income was $7.4 million in Q4 2022 compared to adjusted net income of $1.6 million in Q4 2021. The increase was primarily due to an increase in other operating income and fluctuations in the change of fair value of our warrant liabilities
  • Adjusted EBITDA was $16.3 million in Q4 2022, or +92% compared to adjusted EBITDA of $8.5 million in Q4 2021. Adjusted EBITDA grew despite China’s zero-Covid policy and foreign exchange headwinds encountered during the year

Balance Sheet and Cash Flow Highlights

Cash and cash equivalents were approximately $568.2 million as of December 31, 2022 compared to approximately $901.9 million as of December 31, 2021. Cash and cash equivalents decreased during the year primarily due to $200.0 million in accelerated share repurchase programs and the purchase of inventory to prepare for anticipated future sales growth and the international launch of Syndeo in the second quarter of 2023.

Warrants and Shares Outstanding

The Company had approximately 7.0 million private placement warrants and approximately 132.2 million shares of Class A common stock outstanding as of December 31, 2022. During the fourth quarter of 2022, the Company completed its first $100.0 million accelerated share repurchase transaction, which was announced September 27, 2022, and retired a total of approximately 9.3 million shares. The Company expects to complete its second $100.0 million accelerated share repurchase transaction, which was announced on November 10, 2022, by the end of the second quarter of 2023.

2023 Outlook

BeautyHealth expects net sales in the range of $450 to $470 million for fiscal 2023, reflecting management’s confidence in the business as the Company executes against its growth plan. The Company is also reiterating its outlook for fiscal 2023 adjusted EBITDA margin of 18% to 20% and its fiscal 2025 long-range outlook of $600 million to $700 million net sales and 25% to 30% adjusted EBITDA margin originally announced at its 2022 Investor Day. The Company also expects fiscal 2023 gross margin to exceed fiscal 2022 gross margin, driven by gross margin expansion in the second half of 2023.

BeautyHealth’s achievement of the anticipated results is subject to risks and uncertainties, including those disclosed in the Company’s filings with the Securities and Exchange Commission. The outlook assumes no material deterioration in general market conditions or other unforeseen circumstances beyond our control and does not take into account the impact of any unanticipated developments in the business or changes in the operating environment, nor does it take into account any acquisitions, dispositions or financings during 2023. In addition, given the uncertainty in the environment in which BeautyHealth is operating, the Company remains cautious of the potential risk for further market closures or other restrictive measures from existing or new COVID-19 strains and the uneven global rollout and adoption of vaccines, as well as inflationary headwinds related to higher raw material, shipping and labor costs. BeautyHealth’s outlook assumes a largely reopened global market, which would be negatively impacted if closures or other restrictive measures persist or are reimplemented.

Conference Call

BeautyHealth will host a conference call on Tuesday, February 28, 2022, at 8:30 a.m. ET to review its full year and fourth quarter financial results. The call may be accessed via live webcast through the “Events & Presentations” page under “News & Events” on our Investor Relations website at https://investors.beautyhealth.com/. A replay of the conference call will be available approximately three hours after the conclusion of the call and can be accessed online at https://investors.beautyhealth.com/.

Non-GAAP Financial Measures

In addition to results determined in accordance with accounting principles generally accepted in the United States of America (GAAP), management utilizes certain non-GAAP financial measures such as adjusted net income (loss), adjusted EBITDA, adjusted EBITDA margin, adjusted gross profit, and adjusted gross margin for purposes of evaluating ongoing operations and for internal planning and forecasting purposes. Management believes that these non-GAAP financial measures, when reviewed collectively with the company’s GAAP financial information, provide useful supplemental information to investors in assessing our operating performance. These non-GAAP financial measures should not be considered as an alternative to GAAP financial information or as an indication of operating performance or any other measure of performance derived in accordance with GAAP, and may not provide information that is directly comparable to that provided by other companies in its industry, as these other companies may calculate non-GAAP financial measures differently, particularly related to non-recurring, unusual items.

The Company does not provide a reconciliation of its fiscal 2023 adjusted EBITDA guidance to net income (loss), the most directly comparable forward looking GAAP financial measure, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, which cannot be done without unreasonable efforts, including adjustments that could be made for changes in fair value of warrant liabilities, integration and acquisition-related expenses, amortization expenses, non-cash stock-based compensation, gains/losses on foreign currency, and other charges reflected in our reconciliation of historic numbers, the amount of which, based on historical experience, could be significant. The presentation of this financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. The Company’s fiscal 2023 adjusted EBITDA guidance is merely an outlook and is not a guarantee of future performance. Stockholders should not rely or place an undue reliance on such forward-looking statements. See “Forward-Looking Statements” for additional information.

Adjusted Gross Profit and Adjusted Gross Margin

Management uses adjusted gross profit and adjusted gross margin to measure profitability and the ability to scale and leverage the costs of delivery systems and consumables. The continued growth of delivery systems is expected to improve adjusted gross margin, as additional delivery systems sold will increase the Company’s recurring consumables net sales, which has higher margins.

Management believes adjusted gross profit and adjusted gross margin are useful measures to the Company and its investors to assist in evaluating operating performance because they provide consistency and direct comparability with past financial performance and between fiscal periods, as the metrics eliminate the effects of amortization, depreciation, and stock-based compensation, which are non-cash expenses that may fluctuate for reasons unrelated to overall continuing operating performance, and other one-time and non-recurring expenses such as write-offs of discontinued product and non-recurring Syndeo initial program logistics and service costs. Adjusted gross margin has been and will continue to be impacted by a variety of factors, including the product mix, geographic mix, direct vs. indirect mix, the average selling price on delivery systems, and new product launches. Management expects adjusted gross margin to fluctuate over time depending on the factors described above.

The following table reconciles gross profit to adjusted gross profit for the periods presented:

 

Three months ended December 31,

 

Year ended December 31,

Unaudited (in thousands)

2022

 

2021

 

2022

 

2021

Net sales

$

98,133

 

 

$

77,889

 

 

$

365,876

 

 

$

260,086

 

Cost of sales

 

32,959

 

 

 

21,128

 

 

 

115,536

 

 

 

78,259

 

Gross profit

$

65,174

 

 

$

56,761

 

 

$

250,340

 

 

$

181,827

 

Gross margin

 

66.4

%

 

 

72.9

%

 

 

68.4

%

 

 

69.9

%

Adjusted to exclude the following:

 

 

 

 

 

 

 

Write-off of discontinued product (1)

$

 

 

$

 

 

$

2,048

 

 

$

 

Non-recurring Syndeo initial program logistics and service costs (2)

 

2,400

 

 

 

 

 

 

2,400

 

 

 

 

Stock-based compensation expense included in cost of sales

 

215

 

 

 

183

 

 

 

839

 

 

 

405

 

Depreciation and amortization expense included in cost of sales

 

3,119

 

 

 

2,651

 

 

 

11,576

 

 

 

10,398

 

Adjusted gross profit

$

70,908

 

 

$

59,595

 

 

$

267,203

 

 

$

192,630

 

Adjusted gross margin

 

72.3

%

 

 

76.5

%

 

 

73.0

%

 

 

74.1

%

___________________

(1)

Primarily represents a one-time write-off primarily related to the discontinued Glow & Go pilot program.

(2)

Primarily represents costs associated with Syndeo’s US launch and international launch readiness, including premiums paid on accelerated manufacturing and shipping.

Adjusted Net Income, Adjusted EBITDA and Adjusted EBITDA Margin

Adjusted net income, adjusted EBITDA, and adjusted EBITDA margin are key performance measures that management uses to assess the Company’s operating performance. Because adjusted net income, adjusted EBITDA and adjusted EBITDA margin facilitate internal comparisons of our historical operating performance on a more consistent basis, management uses these measures for business planning purposes.

Management also believes this information will be useful for investors to facilitate comparisons of operating performance and better identify trends in the business. Management expects adjusted EBITDA margin to increase over the long-term, as the Company continues to scale its business and achieve greater operating leverage.

The Company calculates adjusted net income as net income (loss) adjusted to exclude: change in fair value of public and private placement warrants; change in fair value of earn-out shares liability; amortization expense; loss on disposal of assets; stock-based compensation expense; interest income; other expense, net; management fees incurred from historical private equity owners; transaction related costs (including transactions costs with respect to the Business Combination), non-recurring patent litigation fees; reorganization fees such as employee severance, executive recruiting fees and executive signing bonuses; other non-recurring and one-time fees such as Syndeo initial program logistics and service costs and refinancing costs associated with amending our credit agreement; and the aggregate adjustment for income taxes for the tax effect of the adjustments described above.

The Company calculates adjusted EBITDA as net income (loss) adjusted to exclude: change in fair value of public and private placement warrants; change in fair value of earn-out shares liability; amortization expense; loss on disposal of assets; stock-based compensation expense; interest income; other expense, net; management fees incurred from historical private equity owners; transaction related costs (including transactions costs with respect to the Business Combination), non-recurring patent litigation fees; reorganization fees such as employee severance, executive recruiting fees and executive signing bonuses; other non-recurring and one-time fees such as Syndeo initial program logistics and service costs and refinancing costs associated with amending our credit agreement; the aggregate adjustment for income taxes for the tax effect of the adjustments described above; depreciation expense; interest expense; net foreign currency (gain) loss, net; and the remaining benefit for income taxes.

The following table reconciles BeautyHealth’s net income (loss) to adjusted net income (loss) and adjusted EBITDA for the periods presented:

 

Three months ended December 31,

 

Year ended December 31,

Unaudited (in thousands)

2022

 

2021

 

2022

 

2021

Net income (loss)

$

3,815

 

 

$

(17,311

)

 

$

44,384

 

 

$

(375,108

)

Adjusted to exclude the following:

 

 

 

 

 

 

 

Change in FV of warrant liability

 

(6,822

)

 

 

5,982

 

 

 

(78,343

)

 

 

277,315

 

Change in FV of earn-out shares liability

 

 

 

 

 

 

 

 

 

 

47,100

 

Amortization expense

 

4,121

 

 

 

3,943

 

 

 

15,709

 

 

 

13,297

 

Loss on disposal of assets

 

542

 

 

 

 

 

 

5,239

 

 

 

 

Stock-based compensation expense

 

7,619

 

 

 

3,794

 

 

 

28,495

 

 

 

12,418

 

Interest income

 

(5,565

)

 

 

 

 

 

(9,175

)

 

 

(39

)

Other expense, net

 

1,270

 

 

 

160

 

 

 

1,650

 

 

 

4,489

 

Management fees (1)

 

 

 

 

 

 

 

 

 

 

209

 

Transaction related costs (2)

 

20

 

 

 

2,600

 

 

 

3,051

 

 

 

34,913

 

Nonrecurring patent litigation fees

 

2,797

 

 

 

 

 

 

3,797

 

 

 

 

Re-organization fees (3)

 

276

 

 

 

1,997

 

 

 

3,582

 

 

 

1,997

 

Other non-recurring and one-time fees (4)

 

2,764

 

 

 

1,326

 

 

 

4,905

 

 

 

2,020

 

Aggregate adjustment for income taxes

 

(3,443

)

 

 

(881

)

 

 

(14,187

)

 

 

(14,133

)

Adjusted net income (loss)

$

7,394

 

 

$

1,610

 

 

$

9,107

 

 

$

4,478

 

Depreciation expense

 

1,895

 

 

 

2,040

 

 

 

7,164

 

 

 

4,486

 

Interest expense

 

3,395

 

 

 

3,488

 

 

 

13,392

 

 

 

11,777

 

Foreign currency (gain) loss, net

 

1,364

 

 

 

(594

)

 

 

3,164

 

 

 

69

 

Remaining benefit for income taxes

 

2,221

 

 

 

1,944

 

 

 

14,835

 

 

$

11,891

 

Adjusted EBITDA

$

16,269

 

 

$

8,488

 

 

$

47,662

 

 

$

32,701

 

Adjusted EBITDA margin

 

16.6

%

 

 

10.9

%

 

 

13.0

%

 

 

12.6

%

___________________

(1)

Represents quarterly management fees paid to the former majority shareholder of Hydrafacial based on a pre-determined formula. Following the Business Combination, these fees are no longer paid.

(2)

For the three months and year ended December 31, 2022, such amounts primarily represent direct costs incurred in relation to potential acquisitions. For the year ended December 31, 2021, such amounts primarily represent direct costs incurred with the Business Combination and to prepare Hydrafacial to be marketed for sale by Hydrafacial’s shareholders in previous periods.

(3)

For the three months and year ended December 31, 2022, such costs primarily represent executive recruiting fees, severance fees and a CEO sign-on bonus. For the three months and year ended December 31, 2021, such costs primarily represent executive recruiting and severance fees.

(4)

For the three months and year ended December 31, 2022, such costs primarily represent costs associated with Syndeo’s US launch and international launch readiness, including premiums paid on accelerated manufacturing and shipping, and refinancing costs associated with our credit agreement. For the three months ended and year ended December 31, 2021, such costs primarily represent one-time retention awards related to the distributor acquisitions.

About the Business Combination

On May 4, 2021, Vesper Healthcare Acquisition Corp. (“Vesper Healthcare”), a special purpose acquisition company, completed the previously announced business combination (the “Business Combination”) with Edge Systems LLC d/b/a The Hydrafacial Company (“Hydrafacial”). In connection with the Business Combination, Vesper Healthcare changed its name to The Beauty Health Company, and LCP Edge Intermediate, Inc., the indirect parent of Hydrafacial, became an indirect subsidiary of BeautyHealth. For fiscal periods following the date of completion of the Business Combination, financial results are reported by The Beauty Health Company on a consolidated basis.

About The Beauty Health Company

The Beauty Health Company (NASDAQ: SKIN) is a global category-creating company delivering beauty health experiences that help consumers reinvent their relationship with their skin, bodies and self-confidence. Our flagship brand, Hydrafacial, created the category of hydradermabrasion by using a patented vortex-fusion delivery system to cleanse, extract, and hydrate the skin with proprietary solutions and serums. Hydrafacial provides a non-invasive and approachable skincare experience. Together, with our powerful community of aestheticians, consumers and partners, we are personalizing skin care solutions for all ages, genders, skin tones, and skin types. Hydrafacial is available in more than 90 countries with an install base of over 25,000 delivery systems providing millions of experiences to consumers each year. Find a local Hydrafacial at https://hydrafacial.com/find-a-provider/. For more information, visit www.beautyhealth.com.

Forward-Looking Statements

Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding The Beauty Health Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.

These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside The Beauty Health Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.

Important factors that may affect actual results or outcomes include, among others: The Beauty Health Company’s ability to manage growth; The Beauty Health Company’s ability to execute its business plan; potential litigation involving The Beauty Health Company; changes in applicable laws or regulations; the possibility that The Beauty Health Company may be adversely affected by other economic, business, and/or competitive factors; and the impact of the continuing COVID-19 pandemic on the Company’s business. The Beauty Health Company does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

The Beauty Health Company

Consolidated Statements of Comprehensive Income (Loss)

(in thousands except share and per share amounts)

(Unaudited)

 

Three Months Ended December 31,

 

Year Ended December 31,

 

2022

 

2021

 

2022

 

2021

Net sales

$

98,133

 

 

$

77,889

 

 

$

365,876

 

 

$

260,086

 

Cost of sales

 

32,959

 

 

 

21,128

 

 

 

115,536

 

 

 

78,259

 

Gross profit

 

65,174

 

 

 

56,761

 

 

 

250,340

 

 

 

181,827

 

Operating expenses:

 

 

 

 

 

 

 

Selling and marketing

 

39,021

 

 

 

37,053

 

 

 

160,076

 

 

 

111,583

 

Research and development

 

1,446

 

 

 

1,875

 

 

 

8,444

 

 

 

8,195

 

General and administrative

 

28,472

 

 

 

25,045

 

 

 

106,100

 

 

 

98,688

 

Total operating expenses

 

68,939

 

 

 

63,973

 

 

 

274,620

 

 

 

218,466

 

Loss from operations

 

(3,765

)

 

 

(7,212

)

 

 

(24,280

)

 

 

(36,639

)

Interest expense, net

 

3,395

 

 

 

3,488

 

 

 

13,392

 

 

 

11,777

 

Interest income

 

(5,565

)

 

 

 

 

 

(9,175

)

 

 

(39

)

Other expense, net

 

1,270

 

 

 

160

 

 

 

1,650

 

 

 

4,489

 

Change in fair value of warrant liabilities

 

(6,822

)

 

 

5,982

 

 

 

(78,343

)

 

 

277,315

 

Change in fair value of earn-out shares liability

 

 

 

 

 

 

 

 

 

 

47,100

 

Foreign currency transaction (gain) loss, net

 

1,364

 

 

 

(594

)

 

 

3,164

 

 

 

69

 

Income (loss) before provision for income taxes

 

2,593

 

 

 

(16,248

)

 

 

45,032

 

 

 

(377,350

)

Income tax expense (benefit)

 

(1,222

)

 

 

1,063

 

 

 

648

 

 

 

(2,242

)

Net income (loss)

$

3,815

 

 

$

(17,311

)

 

$

44,384

 

 

$

(375,108

)

Comprehensive income (loss), net of tax:

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

2,195

 

 

 

594

 

 

 

(3,273

)

 

 

(1,499

)

Comprehensive income (loss)

$

6,010

 

 

$

(16,717

)

 

$

41,111

 

 

$

(376,607

)

Net income (loss) per share

 

 

 

 

 

 

 

Basic

$

0.03

 

 

$

(0.12

)

 

$

0.30

 

 

$

(3.67

)

Diluted

$

0.03

 

 

$

(0.12

)

 

$

(0.23

)

 

$

(3.67

)

Weighted average common shares outstanding

 

 

 

 

 

 

 

Basic

 

138,198,781

 

 

 

146,300,438

 

 

 

147,554,090

 

 

 

102,114,949

 

Diluted

 

138,198,781

 

 

 

146,300,438

 

 

 

148,506,312

 

 

 

102,114,949

 

The Beauty Health Company

Consolidated Balance Sheets

(in thousands, except for share amounts)

(Unaudited)

 

 

December 31, 2022

 

December 31, 2021

ASSETS

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

568,197

 

 

$

901,886

 

Accounts receivable, net of allowances for doubtful accounts of $2,929 and $2,681 at December 31, 2022 and December 31, 2021, respectively

 

76,494

 

 

 

46,824

 

Prepaid expenses and other current assets

 

26,698

 

 

 

12,322

 

Income tax receivable

 

1,280

 

 

 

4,599

 

Inventories

 

116,430

 

 

 

35,261

 

Total current assets

 

789,099

 

 

 

1,000,892

 

Property and equipment, net

 

18,184

 

 

 

16,183

 

Right-of-use assets, net

 

15,637

 

 

 

14,992

 

Intangible assets, net

 

46,386

 

 

 

56,010

 

Goodwill

 

124,593

 

 

 

123,694

 

Deferred income tax assets, net

 

815

 

 

 

330

 

Other assets

 

14,193

 

 

 

6,705

 

TOTAL ASSETS

$

1,008,907

 

 

$

1,218,806

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

30,335

 

 

$

29,049

 

Accrued payroll-related expenses

 

21,677

 

 

 

28,662

 

Other accrued expenses

 

15,183

 

 

 

14,722

 

Lease liabilities, current

 

4,958

 

 

 

3,712

 

Income tax payable

 

962

 

 

 

292

 

Total current liabilities

 

73,115

 

 

 

76,437

 

Lease liabilities, non current

 

12,689

 

 

 

12,781

 

Deferred income tax liabilities, net

 

2,011

 

 

 

3,561

 

Warrant liabilities

 

15,473

 

 

 

93,816

 

Convertible senior notes, net

 

734,143

 

 

 

729,914

 

TOTAL LIABILITIES

 

837,431

 

 

 

916,509

 

Stockholders’ equity:

 

 

 

Class A Common Stock, $0.0001 par value; 320,000,000 shares authorized; 132,214,695 and 150,598,047 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively

 

14

 

 

 

16

 

Preferred Stock, $0.0001 par value; 1,000,000 shares authorized; no shares issued and outstanding at December 31, 2022 and December 31, 2021

 

 

 

 

 

Additional paid-in capital

 

550,320

 

 

 

722,250

 

Accumulated other comprehensive loss

 

(4,530

)

 

 

(1,257

)

Accumulated deficit

 

(374,328

)

 

 

(418,712

)

Total stockholders’ equity

 

171,476

 

 

 

302,297

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

$

1,008,907

 

 

$

1,218,806

 

 

The One Nine Three Group

Investors: [email protected]

Press: [email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Cosmetics Retail Consumer Women Teens Specialty Men

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Enveric Biosciences Appoints Kevin Coveney as Chief Financial Officer, and Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

Enveric Biosciences Appoints Kevin Coveney as Chief Financial Officer, and Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

30+ year pharmaceutical industry veteran joins Enveric’s executive team to lead company’s financial and capital markets activities.

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, announced today the appointment of Kevin Coveney, CPA, to the position of Chief Financial Officer, effective March 13, 2023. Mr. Coveney brings 30+ years of accounting, finance, and operations experience to Enveric, having previously served as Chief Financial Officer for multiple biotechnology companies.

As CFO, Mr. Coveney will be responsible for leading Enveric’s financial and capital markets activities as the Company targets multiple anticipated growth drivers resulting from the advancement of its EVM201 Series and EVM301 Series programs. Mr. Coveney joins Enveric’s leadership team alongside Joseph Tucker, Ph.D., CEO, Avani Kanubaddi, President and COO, Bob Dagher, M.D., Chief Medical Officer, Peter Facchini, Ph.D., Chief Innovation Officer, and Lynn Gallant, who was recently hired as Vice President, Clinical Operations.

“We are extremely pleased to add Kevin to the leadership team at Enveric Biosciences. He is ideally suited for this role given his prior executive experience at multiple life sciences companies and track record executing growth strategies that translate to shareholder value,” said Joseph Tucker, Ph.D., Director and CEO of Enveric Biosciences. “We believe that as CFO, Kevin will strive to ensure Enveric has the proper financial structures and discipline in place to enable our near-term and longer-range growth objectives, including the development of our EVM201 and EVM301 product platforms.”

Mr. Coveney joins Enveric after serving as a fractional CFO to emerging life science and digital health companies to support the development of the companies’ finance and accounting departments as well as venture capital fundraising strategy. Companies that Mr. Coveney provided CFO services to include Progressive Therapeutics, Power of Patients, and VSI.

Previously, Mr. Coveney was CFO of Memgen, Inc., a clinical-stage immune-oncology company focused on developing cancer immunotherapies that can safely activate the immune system and be combined with other drugs to eradicate cancer. Prior to Memgen, Mr. Coveney was CFO of Q-State Biosciences, a biotech company focused on CNS disorders, where he was responsible for all investor financial due diligence inquiries and financial reporting requirements to investors and strategic collaboration partners. Before Q-State, Mr. Coveney was Senior Vice President of Finance, HR & IT at Vedanta Biosciences, a private microbiome company developing a therapy for Clostridium difficile infection. Prior to Vedanta, Mr. Coveney served roles of increasing responsibility at Berg Health, a family office/VC-backed clinical-stage biotech focused on oncology with a machine learning/AI platform to improve drug discovery and development. Mr. Coveney has also held senior positions at several global accounting firms, including Grant Thornton, Marcum, Deloitte & Touche, BDO Seidman, and Ernst & Young. Mr. Coveney earned his BS in management from the University of Massachusetts and served as a non-commission officer in the United States Coast Guard.

“I am excited to join the team at Enveric at such a crucial time for the Company,” said Mr. Coveney. “With multiple milestones on the horizon, I look forward to working with Joe and the leadership team to strengthen Enveric’s financial and capital markets activities so that we are optimally positioned to pursue our goal of developing ‘next generation’ drug technologies for the treatment of underserved mental health conditions, including anxiety disorders and depression, and by doing so, generate value for both patients and shareholders.”

The Company has agreed to grant, on March 13, 2023 upon the effective date of Mr. Coveney as Chief Financial Officer of the Company, an award of restricted stock units (“RSUs”) convertible into an aggregate of 26,500 shares of the Company’s common stock to Mr. Coveney, to serve as the Company’s Chief Financial Officer, as an inducement award outside of the Company’s 2020 Long-Term Incentive Plan. Subject to certain exceptions including change in control or termination of employment, the awarded RSUs shall vest in four equal installments on each of the first four anniversaries of the date of grant. The grant was approved by the board of directors of the Company and will be made as an inducement material to Mr. Coveney entering into employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders. Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New Chemical Entities for specific mental health indications. Enveric’s lead program, the EVM201 Series, comprises next generation synthetic psilocybin analogues that are considered prodrugs of the active metabolite, psilocin. Enveric is developing the first product from the EVM201 Series – EB-373 – for the treatment of anxiety disorders. Enveric is also advancing its third generation of therapeutics, the EVM301 Series, to offer a holistic approach for treating central nervous system disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.

Forward-Looking Statements

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of not purely historical statements, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations

Tiberend Strategic Advisors, Inc.

Daniel Kontoh-Boateng

(862) 213-1398

[email protected]

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Mental Health Biometrics

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Arrowhead Announces Interim Results from Ongoing Phase 1/2 Study of ARO-C3 for Treatment of Complement Mediated Diseases

Arrowhead Announces Interim Results from Ongoing Phase 1/2 Study of ARO-C3 for Treatment of Complement Mediated Diseases

– Achieved Mean Reductions of 88% in C3 and 91% in AH50

PASADENA, Calif.–(BUSINESS WIRE)–
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced interim results from Part 1 of AROC3-1001, an ongoing Phase 1/2 clinical study of ARO-C3, the company’s investigational RNA interference (RNAi) therapeutic designed to reduce production of complement component 3 (C3) as a potential therapy for various complement mediated diseases. The company plans to present additional results at an upcoming complement-focused medical meeting. Dosing in Part 2 of the Phase 1/2 study is expected to begin in the first half of 2023.

In Part 1 of AROC3-1001, ARO-C3 interim results included:

  • A dose-dependent reduction in serum C3, with 88% mean reduction at highest dose tested
  • A dose-dependent reduction in AH50, a marker of alternative complement pathway hemolytic activity, with 91% mean reduction at highest dose tested
  • Duration of pharmacologic effect supportive of quarterly or less frequent subcutaneous dose administration
  • Safety and tolerability

    • Overall, no clinically significant laboratory findings or patterns of adverse changes in any clinical laboratory parameters
    • No dose limiting toxicity, serious or severe adverse events, or study discontinuation due to adverse events
    • Most common adverse events include headache, COVID-19, generally mild injection site reactions, and seasonal allergy

“ARO-C3 has achieved encouraging results in Part 1 of this Phase 1/2 clinical study, including a mean reduction of 88% in C3 and 91% in AH50 at the highest dose tested. These data in healthy volunteers provide us with further confidence as we begin Part 2 of the study, which includes patients with various complement mediated diseases,” said James Hamilton, M.D., MBA, chief of discovery and translational medicine at Arrowhead. “Substantial unmet medical need remains in the treatment of multiple complement mediated diseases, including IgA nephropathy, C3 glomerulopathy, paroxysmal nocturnal hemoglobinuria, and additional renal and hematologic indications, despite the availability of approved complement C5 inhibitors that have significantly improved treatment. In addition, we believe C3 inhibition has interesting potential, as it is upstream of C5 in the complement cascade.”

AROC3-1001 (NCT05083364) is a Phase 1/2, placebo controlled, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ARO-C3 in up to 42 adult healthy volunteers (Part 1), and up to 42 adult patients with paroxysmal nocturnal hemoglobinuria (PNH) or with complement-mediated renal disease (Part 2).

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.

For more information, please visit www.arrowheadpharma.com, or follow us on Twitter @ArrowheadPharma. To be added to the Company’s email list and receive news directly, please visit http://ir.arrowheadpharma.com/email-alerts.

Safe Harbor Statement under the Private Securities Litigation Reform Act:

This news release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “hope,” “intend,” “plan,” “project,” “could,” “estimate,” “continue,” “target,” “forecast” or “continue” or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects, or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.

Vince Anzalone, CFA

626-304-3400

[email protected]

Investors:

LifeSci Advisors, LLC

Brian Ritchie

212-915-2578

[email protected]

www.lifesciadvisors.com

Media:

LifeSci Communications, LLC

Josephine Belluardo, Ph.D.

646-751-4361

[email protected]

www.lifescicommunications.com

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Health Genetics Pharmaceutical Clinical Trials

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MindMed to Participate in March Investor Conferences

MindMed to Participate in March Investor Conferences

NEW YORK–(BUSINESS WIRE)–
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that members of the Company’s management team will participate in the following investor conferences:

  • Cowen 43rd Annual Healthcare Conference

  • Oppenheimer 33rd Annual Healthcare Conference

  • 35th Annual Roth Conference

    • Format: Fireside Chat
    • Date and Time: Monday, March 13, 2023 at 2:30 pm PST/5:30 pm EST
    • Webcast Link: ​​35th Annual Roth Conference

Audio webcasts and replays of these presentations will be available on MindMed’s Investor Resources website for up to 90 days following each event.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.

MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

For Media & Investor Inquiries, please contact:

Maxim Jacobs, CFA

Vice President, Investor Relations and Corporate Communications

Mind Medicine (MindMed) Inc.

[email protected]

[email protected]

KEYWORDS: New York North America United States United Kingdom Europe Canada

INDUSTRY KEYWORDS: Neurology Biotechnology Pharmaceutical Finance General Health Health Professional Services Clinical Trials

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Camping World Declares First Quarter Dividend For Stockholders of Record on March 14, 2023 to be paid on March 29, 2023

Camping World Declares First Quarter Dividend For Stockholders of Record on March 14, 2023 to be paid on March 29, 2023

LINCOLNSHIRE, Ill.–(BUSINESS WIRE)–
Camping World Holdings, Inc. (NYSE: CWH) (the “Company,” “Camping World,” “we,” “us” or “our”), announced today that its Board of Directors declared a regular cash dividend of $0.625 per share on the Company’s Class A Common Stock. Payment is expected to be made on March 29, 2023, to stockholders of record at the close of business on March 14, 2023.

Marcus Lemonis, Chairman and Chief Executive Officer stated, “Our organization is taking decisive action on SG&A, capex, and underperforming assets, so that we have the flexibility to continue to make accretive dealership acquisitions and return capital to shareholders through the dividend.”

Future declarations of quarterly dividends are subject to the determination and discretion of Camping World’s Board of Directors based on its consideration of various factors, including the Company’s results of operations, financial condition, level of indebtedness, anticipated capital requirements, contractual restrictions, restrictions in its debt agreements, restrictions under applicable law, receipt of excess or surplus of tax distributions received from CWGS Enterprises, LLC, its business prospects and other factors that Camping World’s Board of Directors may deem relevant.

About Camping World Holdings, Inc.

Camping World Holdings, Inc., headquartered in Lincolnshire, IL, (together with its subsidiaries) is America’s largest retailer of RVs and related products and services. Our vision is to build a long-term legacy business that makes RVing fun and easy, and our Camping World and Good Sam brands have been serving RV consumers since 1966. We strive to build long-term value for our customers, employees, and shareholders by combining a unique and comprehensive assortment of RV products and services with a national network of RV dealerships, service centers and customer support centers along with the industry’s most extensive online presence and a highly trained and knowledgeable team of associates serving our customers, the RV lifestyle, and the communities in which we operate. We also believe that our Good Sam organization and family of programs and services uniquely enables us to connect with our customers as stewards of the RV enthusiast community and the RV lifestyle. With RV Sales and service locations in 42 states, Camping World has grown to become the prime destination for everything RV. For more information, visit www.CampingWorld.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Camping World and other matters. All statements other than statements of historical facts contained in this press release may be forward-looking statements. Statements regarding our future results of operations and financial position, anticipated cost reduction initiatives, including the reduction of SG&A expenses and capital expenditures and elimination of or reduction of underperforming assets, anticipated cost savings from cost reduction initiatives, future financial results, future acquisitions, capital return strategy, and expected dividend payments are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘anticipates,’’ ‘‘could,’’ ‘‘intends,’’ ‘‘targets,’’ ‘‘projects,’’ ‘‘contemplates,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘predicts,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. You should carefully consider the risks and uncertainties that affect our business, including the important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed for the year ended December 31, 2022 and our other reports filed with the SEC. These forward-looking statements speak only as of the date of this communication. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our public announcements and filings with the Securities and Exchange Commission.

For Camping World Holdings, Inc.

Investors

Brett Andress

[email protected]

Media Outlets

[email protected]

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Family Sports General Automotive Consumer Vacation Specialty Retail Other Travel Recreational Vehicles Transportation Outdoors Travel Hunting Online Retail Automotive Other Consumer Discount/Variety Fishing Department Stores Women Seniors Men

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