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Catalent Announces Postponement of Third Quarter 2023 Results and Conference Call

Catalent Announces Postponement of Third Quarter 2023 Results and Conference Call

SOMERSET, N.J.–(BUSINESS WIRE)–
Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced that in light of the circumstances described in the Company’s Form 12b-25 filed on May 11, 2023, with the Securities and Exchange Commission, and the Company’s ongoing focus on finalizing its financial statements and other disclosures in its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023 (the “Form 10-Q”) and completing its quarterly closing processes and procedures, it will be postponing the release of its financial results for the third quarter of fiscal year 2023, ended March 31, 2023, and the conference call previously scheduled for Monday, May 15, 2023 at 8:15 a.m. ET, until Friday, May 19, 2023 at 8:15 a.m. ET.

Third Quarter Fiscal Year 2023 Earnings Conference Webcast

The Company now expects to release financial results for the third quarter of fiscal year 2023, ended March 31, 2023, before the market open on Friday, May 19, 2023, and will host a webcast to discuss the results at 8:15 a.m. ET on the same day. Catalent invites all interested parties to listen to the webcast and view a supplemental slide presentation, both of which will be accessible through Catalent’s website at https://investor.catalent.com. The webcast replay, along with the supplemental slides, will be available for 90 days at https://investor.catalent.com.

About Catalent

Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information www.catalent.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 statements regarding management’s ongoing review of its third fiscal quarter financial statements and the release of the Company’s fiscal third quarter results. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause actual future events, results or achievements to be materially different from the Company’s expectations and projections expressed or implied by the forward-looking statements. The important factors include, but are not limited to, the finalization of the Company’s third quarter financial statements, completion of the Company’s quarterly closing processes and procedures, as well as the general business, financial and accounting risks and the other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended June 30, 2022, filed with the U.S. Securities and Exchange Commission, or the SEC, and the Company’s other filings with the SEC. Forward-looking statements speak only as of the date of this press release and are based on information available to the Company as of the date of this press release, and the Company assumes no obligation to update such forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Paul Surdez, Catalent, Inc.

(732) 537-6325

[email protected]

Media Contact:

Chris Halling

+44 (0)7580 041073

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Pharmaceutical General Health Health Other Health

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Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy

Sarepta Therapeutics Announces Positive Vote from U.S. FDA Advisory Committee Meeting for SRP-9001 Gene Therapy to Treat Duchenne Muscular Dystrophy

– Advisory committee voted 8-6 in support of accelerated approval of SRP-9001

– Regulatory action date is May 29, 2023

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) voted 8 to 6 in support of accelerated approval of SRP-9001 (delandistrogene moxeparvovec) for the treatment of ambulatory patients with Duchenne muscular dystrophy with a confirmed mutation in the DMD gene.

“Today’s advisory committee outcome is extremely important to the patient community, who are in urgent need of new therapies,” said Doug Ingram, president and chief executive officer, Sarepta. “With the May 29 action date our top priority, we will work collaboratively with the FDA to complete the review of our BLA for SRP 9001. We extend our sincere appreciation to the families, clinicians, FDA presenters and committee members who participated in today’s panel and to all those who provided input and comments both in the written record and in the open public hearing.”

SRP-9001 is intended to treat the underlying cause of Duchenne, which is characterized by mutations in the dystrophin gene that results in the lack of dystrophin protein. In the absence of dystrophin, which is required to strengthen and protect muscles, muscles become weakened and damaged. SRP-9001 is intended to deliver a gene that codes for a shortened, functional form of dystrophinto muscle cells. The committee’s positive vote is based on the evaluation of the totality of evidence including the SRP-9001 product design as well as biological and empirical data. SRP-9001 is supported by non-clinical evidence in addition to efficacy and safety data from studies 101, 102 and 103 as well as an integrated analysis across these three clinical studies comparing functional results to a propensity-score-weighted external control (EC).

The CTGTAC’s vote, while not binding, will be considered by the FDA when making its decision regarding the potential accelerated approval of SRP-9001. The Biologics License Application (BLA) for SRP-9001 is currently under priority review by the FDA with a regulatory action date of May 29, 2023.

About SRP-9001 (delandistrogene moxeparvovec)

SRP-9001 (delandistrogene moxeparvovec) is an investigational gene transfer therapy designed to address the underlying cause of DMD through the targeted production of functional components of dystrophin in muscle tissue. Sarepta is responsible for global development and manufacturing for SRP-9001 and plans to commercialize SRP-9001 in the United States upon receiving FDA approval. In December 2019, Roche partnered with Sarepta to combine Roche’s global reach, commercial presence and regulatory expertise with Sarepta’s gene therapy candidate for Duchenne to accelerate access to SRP-9001 for patients outside the United States.

About Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a rare, fatal neuromuscular genetic disease that occurs in approximately one in every 3,500-5,000 newborn males worldwide. DMD is caused by a change or mutation in the gene that encodes instructions for dystrophin. Symptoms of DMD usually appear in infants and toddlers. Affected children may experience developmental delays such as difficulty in walking, climbing stairs or standing from a sitting position. As the disease progresses, muscle weakness in the lower limbs spreads to the arms and other areas. Most patients require full-time use of a wheelchair in their early teens, and then progressively lose the ability to independently perform activities of daily living such as using the restroom, bathing and feeding. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and patients usually succumb to the disease in their twenties.

About Sarepta Therapeutics

Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development. Our vast pipeline is driven by our multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing. For more information, please visit www.sarepta.com or follow us on Twitter, LinkedIn, Instagram and Facebook.

Internet Posting of Information

We routinely post information that may be important to investors in the ‘For Investors’ section of our website at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Forward-Looking Statements

This press release contains “forward-looking statements.” Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements relating to our future operations, business plans, priorities, research and development programs;SRP-9001’s potential for accelerated approval; the Company’s plans to continue working with the FDA as they complete their review of the SRP-9001 BLA; the potentially transformative benefits of SRP-9001; and that the FDA is not bound by the advisory committee recommendation but takes its advice in consideration when reviewing applications.

Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: the FDA may not approve the BLA for SRP-9001 by the application PDUFA date or at all; we may not be able to comply with all FDA requests, including with respect to our SRP-9001 BLA, in a timely manner or at all; the possible impact of regulations and regulatory decisions by the FDA and other regulatory agencies on our business, as well as the development of our product candidates and our financial and contractual obligations; our dependence on certain manufacturers to produce our products and product candidates, including any inability on our part to accurately anticipate product demand and timely secure manufacturing capacity to meet product demand, may impair the availability of product to successfully support various programs; our data for SRP-9001 may not be sufficient for obtaining regulatory approval; success in preclinical and clinical trials, especially if based on a small patient sample, does not ensure that later clinical trials will be successful, and the results of future research may not be consistent with past positive results or with advisory committee recommendations, or may fail to meet regulatory approval requirements for the safety and efficacy of product candidates; the commencement and completion of our clinical trials and announcement of results may be delayed or prevented for a number of reasons, including, among others, denial by the regulatory agencies of permission to proceed with our clinical trials, or placement of a clinical trial on hold, challenges in identifying, recruiting, enrolling and retaining patients to participate in clinical trials and inadequate quantity or quality of supplies of a product candidate or other materials necessary to conduct clinical trials; different methodologies, assumptions and applications we use to assess particular safety or efficacy parameters may yield different statistical results, and even if we believe the data collected from clinical trials of our product candidates are positive, these data may not be sufficient to support approval by the FDA or other global regulatory authorities; we may not be able to execute on our business plans, including meeting our expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing our product candidates to market, for various reasons, many of which may be outside of our control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, regulatory, court or agency decisions, such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates, and the ongoing COVID-19 pandemic; and those risks identified under the heading “Risk Factors” in our most recent Annual Report on Form 10-K for the year ended December 31, 2022 and Form 10-Q filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. For a detailed description of risks and uncertainties Sarepta faces, you are encouraged to review the SEC filings made by Sarepta. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except as required by law.

Investor Contact:

Ian Estepan, 617-274-4052

[email protected]

Media Contact:

Tracy Sorrentino, 617-301-8566

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: FDA Health Research Pharmaceutical Science Biotechnology

MEDIA:

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Blue Water Biotech Reports First Quarter 2023 Financial Results and Recent Business Highlights

CINCINNATI, May 12, 2023 (GLOBE NEWSWIRE) — Blue Water Biotech, Inc. (“Blue Water” or the “Company”), a biotechnology company spanning multiple sectors, today announced its financial results for the quarter ended March 31, 2023 and provided an update on recent business developments and Company progress. Blue Water Biotech is a biological and pharmaceutical technology company developing multiple preclinical vaccine candidates across various infectious diseases and owns the FDA-approved benign hyperplasia (“BPH”) asset, ENTADFI®.

“Blue Water’s recent growth is highlighted by our acquisition of ENTADFI®, as well as our subsequent rebranding initiative and name change to reflect our transition into a commercial-stage biotechnology company,” said Joseph Hernandez, Chairman and Chief Executive Officer of Blue Water. “We believe this product has the potential to be transformative for men suffering from BPH, and we are confident that our experienced management team will be the driving force behind ENTADFI®’s anticipated success. We are also excited to bring in an approved asset to support the operations for our preclinical vaccine programs, including our Streptococcus pneumoniae vaccine candidate that is progressing towards clinical trials in the near term.”

Q1 2023 and Recent Corporate Developments

  • In April 2023, Blue Water announced the acquisition of ENTADFI®, an FDA-approved treatment for BPH that counteracts negative sexual side effects seen in men on alternative BPH therapies.
    • Under the asset purchase agreement, Blue Water purchased ENTADFI® for a total consideration of up to $100 million, with $20 million upfront, paid in defined tranches through September 2024, and the possibility of an additional $80 million based on predetermined annual sales milestones.
    • Following this acquisition, Blue Water announced in April 2023 that the Company changed its corporate name to Blue Water Biotech, Inc. to reflect its transition into a commercial-stage company.
  • In February 2023, Blue Water announced the appointment of seasoned commercial operations leader Frank Jaeger as Senior Vice President of Marketing and Business Development. Blue Water will leverage Mr. Jaeger’s experience, specifically in Men’s Health through his experience with JATENZO® and AndroGel 1.62%, in the official launch of ENTADFI® and its anticipated success within the BPH market.
  • Throughout the first quarter of 2023 and beyond, Blue Water management presented its corporate overview and Company updates at key investor, financial, and scientific conferences to highlight the value story of the Blue Water pipeline and target leaders within the investment community.
    • In January 2023, Blue Water presented an overview of its vaccine candidate pipeline and progress at Biotech Showcase 2023 during the 41st annual J.P. Morgan Healthcare Conference Week in San Francisco, California. In addition, Blue Water management participated in the World Vaccine Congress in Washington D.C. in April 2023.
    • To promote ENTADFI® and connect with key leaders in the urology space, Blue Water management sponsored a booth at the American Urological Association Annual Meeting 2023 in Chicago, Illinois.
  • In January 2023, Blue Water announced the appointment of seasoned public market and private equity investment leader, Timothy Ramdeen, to its board of directors. Mr. Ramdeen has nearly a decade of experience in private equity and hedge fund investing, capital markets, and company formation.

Q1 2023 and Recent Vaccine Candidate Developments

  • In February 2023, Blue Water announced a partnership with AbVacc, Inc. (“AbVacc”) for the joint development of novel vaccine candidates targeting monkeypox and Marburg virus disease, among others. The vaccine candidates will utilize Blue Water’s norovirus shell and protrusion virus-like particle platform, which allows for the presentation of multiple antigens on the surface of either the S or P particle of a norovirus backbone. Under this partnership, Blue Water and AbVacc will work collaboratively to identify appropriate antigens to use within this platform and will work toward clinical development of vaccine candidates.
  • In March 2023, Blue Water signed a sponsored research agreement with The University of Texas Health Science Center at San Antonio to initiate a non-human primate study for Blue Water’s live attenuated, orally delivered Chlamydia vaccine, BWV-401. In this study, non-human primates will be vaccinated with BWV-401 and subsequently challenged against Chlamydia to validate they hypothesis that this vaccine is both safe and efficacious in a human-like model.

Q1 2023 Financial Highlights

  • Cash Position: Cash was $20.3 million as of March 31, 2023, as compared to $25.8 million as of December 31, 2022. The decrease was primarily due to an increase in various business activities to support company growth, as well as increased research and development activities.
  • Research and Development Expenses: For the three months ended March 31, 2023, research and development expenses increased by approximately $0.6 million compared to the same period in 2022. The increase was primarily attributable to an increase in preclinical development activities of approximately $0.3 million mainly related to BWV-101 and BWV-201, and an increase in research and development personnel costs.
  • General and Administrative Expenses: For the three months ended March 31, 2023, general and administrative expenses increased by $0.2 million compared to the same period in 2022. The increase was mainly due to an increase in professional fees and an increase in various business activities related to company growth and development, such as business advisory services, travel, and rent expenses. These increases were offset by a decrease in employee compensation, as well as a non-recurring expense in the three months ended March 31, 2022 to early terminate an agreement with an underwriter, with no similar expense in the current period.
  • Other Income: Other income relates to the change in fair value of the contingent warrant liability, which was incurred at the close of the Company’s private placements in April and August 2022. There was no other income or expense during the three months ended March 31, 2022.
  • Net Loss: Net loss was approximately $2.8 million for the three months ended March 31, 2023, as compared to $2.1 million for the same period in 2022. The increase is primarily due to research and development of preclinical vaccine candidates.

BLUE WATER BIOTECH, INC.

Condensed Balance Sheets

    March 31,
2023 		    December 31,
2022 		 
ASSETS    (Unaudited)        
Current assets            
Cash   $ 20,255,803     $ 25,752,659  
Restricted cash     1,000,000       —  
Prepaid expenses and other current assets     780,173       469,232  
Deferred offering costs     366,113       —  
Receivable from related parties     70,302       35,850  
Total current assets     22,472,391       26,257,741  
                 
Prepaid expenses, long-term     15,500       38,617  
Property and equipment, net     14,210       14,089  
Total assets   $ 22,502,101     $ 26,310,447  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities                
Accounts payable   $ 1,503,262     $ 1,499,296  
Accrued expenses     1,292,951       2,409,128  
Contingent warrant liability     12,406       14,021  
Total current liabilities     2,808,619       3,922,445  
                 
Total liabilities     2,808,619       3,922,445  
                 
Commitments and Contingencies                
                 
Stockholders’ equity                
Preferred stock, $0.00001 par value, 10,000,000 shares authorized at March 31, 2023 and December 31, 2022; 0 shares issued and outstanding at March 31, 2023 and December 31, 2022     —        —   
Common stock, $0.00001 par value, 250,000,000 shares authorized at March 31, 2023 and December 31, 2022; 16,371,597 and 15,724,957 shares issued at March 31, 2023 and December 31, 2022, respectively; 15,879,230 and 15,265,228 shares outstanding at March 31, 2023 and December 31, 2022, respectively     164       157  
Additional paid-in-capital     42,516,726       42,331,155  
Treasury stock, at cost; 492,367 and 459,729 shares of common stock at March 31, 2023 and December 31, 2022, respectively     (600,264 )     (566,810 ) 
Accumulated deficit     (22,223,144 )     (19,376,500 )
Total stockholders’ equity     19,693,482       22,388,002  
Total liabilities and stockholders’ equity   $ 22,502,101     $ 26,310,447  

  

BLUE WATER BIOTECH, INC.
Condensed Statements of Operations
(Unaudited)

    Three Months Ended
March 31, 
2023 		    Three Months Ended
March 31, 
2022 		 
Operating expenses            
General and administrative   $ 1,766,022       $ 1,615,569  
Research and development     1,082,237         455,092  
Total operating expenses     2,848,259         2,070,661  
Loss from operations     (2,848,259 )       (2,070,661 )
Other income                
Change in fair value of contingent warrant liability     (1,615 )       —  
Total other income     (1,615 )       —  
Net loss   $ (2,846,644 )     $ (2,070,661 )
Cumulative preferred stock dividends     —         96,359  
Net loss applicable to common stockholders     (2,846,644 )       (2,167,020 )
                 
Net loss per share attributable to common stockholders, basic and diluted   $ (0.18 )     $ (0.34 )
                 
Weighted average number of common shares outstanding, basic and diluted     15,910,415         6,339,435  
                   

About ENTADFI

®

ENTADFI® is an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor, offering a more effective treatment option compared to other available therapies. Clinical trials have shown that ENTADFI® is more effective in treating BPH symptoms, including urinary frequency, urgency, weak stream, and difficulty initiating or maintaining urination, compared to finasteride monotherapy. Additionally, ENTADFI® has demonstrated a favorable safety profile, with fewer adverse sexual side effects compared to finasteride. ENTADFI® reduces potential for adverse sexual side effects, making it a preferred choice for men seeking relief from BPH symptoms without compromising their sexual health. ENTADFI® has received FDA approval for the indication of initiating treatment of the signs and symptoms of BPH in men with an enlarged prostate for up to 26 weeks. More information about BPH and full ENTADFI® prescribing information can be found on the product website at https://entadfipatient.com/.

About Blue Water Biotech

Blue Water Biotech, Inc. is a biological and pharmaceutical technology company focused on developing and providing transformational therapies to address significant health challenges globally. Headquartered in Cincinnati, OH, the Company holds the rights to proprietary technology developed at the University of Oxford, Cincinnati Children’s Hospital Medical Center, St. Jude Children’s Hospital, and The University of Texas Health Science Center at San Antonio. Blue Water is developing a Streptococcus pneumoniae vaccine candidate, designed to specifically prevent highly infectious middle ear infections, known as acute otitis media (AOM), in children, and prevention of pneumonia in the elderly. The Company is also developing a universal flu vaccine that will provide protection from all virulent strains in addition to licensing a novel norovirus (NoV) S&P nanoparticle versatile virus-like particle (VLP) vaccine platform from Cincinnati Children’s to develop vaccines for multiple infectious diseases, including Marburg and monkeypox, among others. Additionally, the Company is developing a Chlamydia vaccine candidate with UT Health Science Center San Antonio to prevent infection and reduce the need for antibiotic treatment associated with contracting Chlamydia disease. Outside of its vaccine franchise, Blue Water owns ENTADFI®, an FDA-approved, once daily pill that combines finasteride and tadalafil for the treatment of benign prostatic hyperplasia. This combination allows men to receive treatment for their symptoms of BPH without the negative sexual side effects typically seen in patients on finasteride alone. For more information about Blue Water, visit www.bwbioinc.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Blue Water’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to Blue Water’s ability to realize the benefits of its acquisition of ENTADFI®, risks related to BWV’s ability to expand its business scope and its ability to commercialize ENTADFI®, risks related to the development of Blue Water’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any vaccine under development, there are significant risks in the development, regulatory approval and commercialization of new products. Blue Water does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Blue Water’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 9, 2023 and periodic reports filed with the SEC on or after the date thereof. All of Blue Water’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Media Contact Information:
Blue Water Media Relations
Telephone: (646) 942-5591
Email: [email protected]

Investor Contact Information:
Blue Water Investor Relations
Email: [email protected] 



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Patriot Reports Break Even First Quarter

Increases Loan Balances, Credit Reserves & Liquidity

STAMFORD, Conn., May 12, 2023 (GLOBE NEWSWIRE) — Patriot National Bancorp, Inc. (“Patriot,” “Bancorp” or the “Company”) (NASDAQ: PNBK), the parent company of Patriot Bank, N.A. (the “Bank”), today announced net loss of $53.0 thousand, or $(0.01) basic and diluted loss per share for the quarter ended March 31, 2023.

These results compared to net income of $1.8 million, or $0.45 per basic and diluted earnings per share for the fourth quarter of 2022 and net income of $800 thousand, or $0.20 basic and diluted earnings per share reported in the first quarter of 2022.

The first quarter of 2023 financial results were adversely impacted by increasing reserves, which resulted in an elevated provision for credit losses of $1.3 million, compared to no provision for loan losses recorded for the first quarter of 2022; and the impact of lower net interest margin which was impacted by the higher funding costs resulting from the recent uncertainty in the banking sector.

The Bank reported steady quarterly loan growth of 3.6%, as compared to December 31, 2022. Net interest margin remained strong at 3.29%. The Bank continued executing its, low-cost deposit gathering strategies to complement its branch franchise. Prepaid deposits have grown to $176.2 million as of March 31, 2023. The combination of timing events associated with the onboarding of new deposit channels and rate increases in the Bank’s steady state deposit funding has resulted in a decrease in net interest margin from the previous quarter. Net interest margin decreased 48bps from 3.77% reported in the fourth quarter of 2022, but increased 23bps from 3.06% for the first quarter of last year. The Bank’s prepaid debit card and deposit strategy programs are expected to increasingly become significant contributors to the Bank’s diversified funding sources.

Patriot President & CEO David Lowery stated: “I am excited to have been promoted to Patriot’s President and CEO and look forward to providing increased value to our customers, driving shareholder returns, and establishing Patriot as a preferred work environment for our employees. The first quarter of 2023 was a particularly challenging time for banks overall. However, during this period, PNBK made great strides in investing in its future, growing and diversifying its loan book and deposit base year over year, and increasing reserves.”

While the full impact of recent investments will take time to flow to the bottom line, the Bank’s strengths can be evidenced by:

  1)   A diversified portfolio with no outsized exposures, ending the quarter split between Commercial Loans, Non-Owner-Occupied CRE, and Consumer Loans at 30%, 44% and 25%, respectively.
  2)   A highly conservative Non-Owner-Occupied CRE portfolio with a weighted average LTV of 47%, and less than 9% of that portfolio attributable to office, land, or construction.
  3)   Minimal duration risk across all loans; 34% of the loan portfolio is tied to variable rates, and the fixed rate loans have a weighted average term to rate reset of less than a year-and-a-half, so they will reprice if deposit costs continue to increase; and
  4)   A deposit base, supported by strong relationships, insulated from risk of flight, with more than 60% federally insured and 20% tied to the Bank’s prepaid vertical.



Financial Results:

Total assets increased to $1.1 billion, as of March 31, 2023, as compared to $1.0 billion on December 31, 2022. This was primarily due to an increase in loans from $848.3 million at December 31, 2022, to $878.8 million as of March 31, 2023. Total deposits for the quarter remained stable at $856.5 million, relative to $860.4 million as of December 31, 2022.

Effective January 1, 2023, the Company adopted ASU 2016-13, pertaining to the measurement of credit losses on financial instruments (“CECL”), and as a result, recorded an increase in the allowance for credit losses on loans of $7.4 million, an allowance for credit losses on off-balance sheet exposure of $1.1 million, and a cumulative adjustment to the opening balance of accumulated deficit of $6.2 million, net of a deferred tax adjustment of $2.3 million. The adoption of CECL does not impact Patriot’s income statement, but such adoption is reflected in Patriot’s shareholder’s equity.

Net interest income for the three months ended March 31, 2023, was $8.0 million, an increase of $1.3 million or 19.1% from the first quarter of 2022 and a decline from $9.6 million reported in the fourth quarter of 2022. The increase from the prior year first quarter was primarily attributable to the growth in the loan portfolio and growth in prepaid deposits from the Bank’s Deposit Strategies Division. The decline from the fourth quarter of 2022 was due to narrower net interest margin due to higher deposit costs and an increase in wholesale borrowings to purposely increase liquidity.

The Bank’s net interest margin was 3.29% for the three months ended March 31, 2023, compared with 3.77% in the fourth quarter of 2022 and 3.06% for the three months ended March 31, 2022.

Non-interest income for the quarter ended March 31, 2023, and 2022 was $835 thousand and $814 thousand, respectively. The higher non-interest income for the quarter ended March 31, 2023, was primarily attributable to higher non-interest income from the Bank’s Deposit Strategies Division.

Non-interest expenses for the quarter ended March 31, 2023, and 2022, were $7.6 million and $6.4 million, respectively.

For the three months ended March 31, 2023, a credit for income taxes of $19 thousand was recorded, compared to a provision for income taxes of $311 thousand for the three months ended March 31, 2022. The effective tax rate for the first quarter of 2023 and 2022 was 26.4% and 28.0%, respectively.

* * * * *

About the Company:

Founded in 1994, and now celebrating its 29th year, Patriot National Bancorp, Inc. (“Patriot” or “Bancorp”) is the parent holding company of Patriot Bank N.A. (“Bank”), a nationally chartered bank headquartered in Stamford, CT. The Bank is headquartered in Stamford and operates 9 branch locations: in Scarsdale, NY; and Darien, Fairfield, Greenwich, Milford, Norwalk, Orange, Stamford, Westport, CT with Express Banking locations at Bridgeport/ Housatonic Community College, downtown New Haven and Trumbull at Westfield Mall. The Bank also maintains SBA lending offices in Stamford, Connecticut, Florida, Georgia, Mississippi, along with a Rhode Island operations center.

Patriot’s mission is to serve its local community and nationwide customer base by providing a growing array of banking solutions to meet the needs of individuals and small businesses owners. Patriot places great value in the integrity of its people and how it conducts business. The emphasis on building strong client relationships and community involvement are cornerstones of Patriot’s philosophy as it seeks to maximize shareholder value.

“Safe Harbor” Statement Under Private Securities Litigation Reform Act of 1995:

Certain statements contained in Bancorp’s public statements, including this one, may be forward looking. These forward-looking statements are based on Patriot’s current expectations and assumptions regarding Patriot’s business, the economy, and other future conditions. Because forward-looking statements relate to future results and occurrences, they are subject to inherent risks, uncertainties, changes in circumstances and other factors that are difficult to predict. Many possible events or factors could affect Patriot’s future financial results and performance and could cause the actual results, performance, or achievements of Patriot to differ materially from any anticipated results expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others: (1) changes in prevailing interest rates which would affect the interest earned on the Company’s interest earning assets and the interest paid on its interest bearing liabilities; (2) the timing of re-pricing of the Company’s interest earning assets and interest bearing liabilities; (3) the effect of changes in governmental monetary policy; (4) the effect of changes in regulations applicable to the Company and the Bank and the conduct of its business; (5) changes in competition among financial service companies, including possible further encroachment of non-banks on services traditionally provided by banks; (6) the ability of competitors that are larger than the Company to provide products and services which it is impracticable for the Company to provide; (7) the state of the economy and real estate values in the Company’s market areas, and the consequent effect on the quality of the Company’s loans; (8) demand for loans and deposits in our market area; (9) recent governmental initiatives that are expected to have a profound effect on the financial services industry and could dramatically change the competitive environment of the Company; (10) other legislative or regulatory changes, including those related to residential mortgages, changes in accounting standards, and Federal Deposit Insurance Corporation (“FDIC”) premiums that may adversely affect the Company; (11) the application of generally accepted accounting principles, consistently applied; (12) the fact that one period of reported results may not be indicative of future periods; (13) the state of the economy in the greater New York metropolitan area and its particular effect on the Company’s customers, vendors and communities; (14) political, social, legal and economic instability, civil unrest, war, catastrophic events, acts of terrorism; (15) possible future outbreaks of infectious diseases, including the ongoing novel coronavirus (COVID-19) outbreak; (16) changes in the level and direction of loan delinquencies and write-offs and changes in estimates of the adequacy of the allowance for loan losses; (17) our ability to access cost-effective funding; (18) our ability to implement and change our business strategies; (19) changes in the quality or composition of our loan or investment portfolios; (20) technological changes that may be more difficult or expensive than expected; (21) our ability to manage market risk, credit risk and operational risk in the current economic environment; (22) our ability to enter new markets successfully and capitalize on growth opportunities; (23) changes in consumer spending, borrowing and savings habits; (24) our ability to retain key employees; (25) our compensation expense associated with equity allocated or awarded to our employees; and (26) other such factors, including risk factors, as may be described in the Company’s other filings with the Securities and Exchange Commission.

PATRIOT NATIONAL BANCORP, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS (Unaudited)

  March 31,

2023 		  December 31,

2022 		  March 31,

2022
Assets          
Cash and due from banks:          
Noninterest bearing deposits and cash $ 1,828     $ 5,182     $ 9,026  
Interest bearing deposits   58,424       33,311       35,290  
Total cash and cash equivalents   60,252       38,493       44,316  
Investment securities:          
Available-for-sale securities, at fair value   91,736       84,520       83,260  
Other investments, at cost   4,450       4,450       4,450  
Total investment securities   96,186       88,970       87,710  
           
Federal Reserve Bank stock, at cost   2,673       2,627       2,869  
Federal Home Loan Bank stock, at cost   6,374       3,874       4,184  
           
Gross loans receivable   878,769       848,316       773,339  
Allowance for credit losses   (17,801 )     (10,310 )     (9,737 )
Net loans receivable   860,968       838,006       763,602  
           
SBA loans held for sale   6,882       5,211       5,820  
Accrued interest and dividends receivable   7,308       7,267       5,596  
Premises and equipment, net   30,467       30,641       31,269  
Deferred tax asset   17,392       15,527       13,755  
Goodwill   1,107       1,107       1,107  
Core deposit intangible, net   238       249       284  
Other assets   10,165       11,387       14,992  
Total assets $ 1,100,012     $ 1,043,359     $ 975,504  
           
Liabilities          
Deposits:          
Noninterest bearing deposits $ 152,773     $ 269,636     $ 237,825  
Interest bearing deposits   703,695       590,810       542,024  
Total deposits   856,468       860,446       779,849  
           
Federal Home Loan Bank and correspondent bank borrowings   150,000       85,000       90,000  
Senior notes, net   11,619       11,640       12,000  
Subordinated debt, net   9,847       9,840       9,818  
Junior subordinated debt owed to unconsolidated trust, net   8,130       8,128       8,121  
Note payable   533       585       740  
Advances from borrowers for taxes and insurance   2,824       886       2,574  
Accrued expenses and other liabilities   5,982       7,251       9,719  
Total liabilities   1,045,403       983,776       912,821  
           
Commitments and Contingencies   –       –       –  
           
Shareholders’ equity          
Preferred stock   –       –       –  
Common stock   106,588       106,565       106,500  
Accumulated deficit   (37,581 )     (31,337 )     (36,698 )
Accumulated other comprehensive loss   (14,398 )     (15,645 )     (7,119 )
Total shareholders’ equity   54,609       59,583       62,683  
           
Total liabilities and shareholders’ equity $ 1,100,012     $ 1,043,359     $ 975,504  

PATRIOT NATIONAL BANCORP, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

  Three Months Ended
(In thousands, except per share amounts) March 31,

2023 		  December 31,

2022 		  March 31,

2022
Interest and Dividend Income          
Interest and fees on loans $ 12,550     $ 12,865     $ 7,664  
Interest on investment securities   680       672       570  
Dividends on investment securities   135       155       65  
Other interest income   281       274       21  
Total interest and dividend income   13,646       13,966       8,320  
           
Interest Expense          
Interest on deposits   3,579       2,641       409  
Interest on Federal Home Loan Bank borrowings   1,373       1,185       737  
Interest on senior debt   290       228       210  
Interest on subordinated debt   326       305       234  
Interest on note payable and other   65       37       4  
Total interest expense   5,633       4,396       1,594  
           
Net interest income   8,013       9,570       6,726  
           
Provision for credit losses   1,336       1,410       —  
           
Net interest income after provision for credit losses   6,677       8,160       6,726  
           
Non-interest Income          
Loan application, inspection and processing fees   123       108       87  
Deposit fees and service charges   68       65       64  
Gains on sale of loans   81       770       208  
Rental income   119       118       192  
Loss on sale of investment securities   24       —       —  
Other income   420       278       263  
Total non-interest income   835       1,339       814  
           
Non-interest Expense          
Salaries and benefits   4,267       4,067       3,346  
Occupancy and equipment expenses   884       849       836  
Data processing expenses   294       275       330  
Professional and other outside services   914       775       789  
Project expenses, net   27       2       52  
Advertising and promotional expenses   85       41       68  
Loan administration and processing expenses   51       50       105  
Regulatory assessments   182       219       174  
Insurance expenses   77       64       77  
Communications, stationary and supplies   191       134       135  
Other operating expenses   612       601       517  
Total non-interest expense   7,584       7,077       6,429  
           
(Loss) income before income taxes   (72 )     2,422       1,111  
           
(Credit) provision for income taxes   (19 )     652       311  
Net (loss) income $ (53 )   $ 1,770     $ 800  
           
Basic (loss) earnings per share $ (0.01 )   $ 0.45     $ 0.20  
Diluted (loss) earnings per share $ (0.01 )   $ 0.45     $ 0.20  

FINANCIAL RATIOS AND OTHER DATA

  Three Months Ended

(Dollars in thousands)
 		March 31,

2023 		  December 31,

2022 		  March 31,

2022
Quarterly Performance Data:          
Net (loss) income $ (53 )   $ 1,770     $ 800  
Return on Average Assets   -0.02 %     0.66 %     0.34 %
Return on Average Equity   -0.39 %     11.72 %     4.88 %
Net Interest Margin   3.29 %     3.77 %     3.06 %
Efficiency Ratio   85.72 %     64.88 %     85.27 %
Efficiency Ratio excluding project costs   85.42 %     64.86 %     84.58 %
% increase (decrease) in loans   3.59 %     -1.69 %     4.58 %
% (decrease) increase in deposits   -0.46 %     3.12 %     4.18 %
           
Asset Quality:          
Nonaccrual loans $ 23,769     $ 18,593     $ 23,466  
Other real estate owned $ —     $ —     $ —  
Total nonperforming assets $ 23,769     $ 18,593     $ 23,466  
           
Nonaccrual loans / loans   2.70 %     2.19 %     3.03 %
Nonaccrual loans / assets   2.16 %     1.78 %     2.41 %
           
Allowance for loan losses $ 17,801     $ 10,310     $ 9,737  
Allowance for loan losses / loans   2.03 %     1.22 %     1.26 %
Allowance / nonaccrual loans   74.89 %     55.45 %     41.49 %
           
Loan charge-offs $ 1,798     $ 1,177     $ 185  
Loan (recoveries) $ (180 )   $ (125 )   $ (17 )
Net loan charge-offs (recoveries) $ 1,618     $ 1,052     $ 168  
           
Capital Data and Capital Ratios          
Book value per share (1) $ 13.77     $ 15.03     $ 15.84  
Non-GAAP Tangible book value per share (2) $ 13.43     $ 14.68     $ 15.49  
Non-GAAP Tangible book value excluding other comprehensive loss per share (3) $ 17.06     $ 18.63     $ 17.29  
           
Shares outstanding   3,965,186     3,965,186     3,956,492
           
Bank Leverage Ratio   9.25 %     9.27 %     9.94 %

(1)   Book value per share represents shareholders’ equity divided by outstanding shares.
(2)   Tangible book value per share represents tangible assets divided by outstanding shares.
(3)   Tangible book value excluding other comprehensive loss per share represents tangible assets excluding unrealized loss on investments, net of income tax divided by outstanding shares.

Deposits:

(In thousands) March 31,

2023 		  December 31,

2022 		  March 31,

2022

Non-interest bearing:
 		         
Non-interest bearing $ 124,388     $ 118,541     $ 120,835  
Prepaid DDA   28,385       151,095       116,990  
Total non-interest bearing   152,773       269,636       237,825  
           

Interest bearing:
 		         
NOW   29,316       34,440       42,272  
Savings   56,418       71,002       105,871  
Money market   158,641       164,827       117,049  
Money market – prepaid deposits   147,833       46,173       29,770  
Certificates of deposit, less than $250,000   162,734       165,793       158,625  
Certificates of deposit, $250,000 or greater   43,664       59,877       53,513  
Brokered deposits   105,089       48,698       34,924  
Total Interest bearing   703,695       590,810       542,024  
           
Total Deposits $ 856,468     $ 860,446     $ 779,849  
           
Total Prepaid deposits $ 176,218     $ 197,268     $ 146,760  
           
Total deposits excluding brokered deposits $ 751,379     $ 811,748     $ 744,925  



Non-GAAP Financial Measures:

In addition to evaluating the Company’s financial performance in accordance with U.S. generally accepted accounting principles (“GAAP”), management may evaluate certain non-GAAP financial measures, such as per share numbers that exclude intangible assets and exclude the net reduction in Book equity resulting from the change in value of its Available for Sale investment securities (AFS). A computation and reconciliation of non-GAAP financial measures used for these purposes is contained in the accompanying Reconciliation of GAAP to Non-GAAP Measures tables. We believe that due to the temporary nature of the change in AFS securities which is a result of the current interest rate environment, providing the Book value per share data excluding the Other Comprehensive Loss associated with the valuation of AFS securities provides investors with information useful in understanding our financial position. The non-GAAP financial measures should not be considered a substitute for GAAP basis measures and results, and we strongly encourage investors to review our consolidated financial statements in their entirety and not to rely on any single financial measure.

Reconciliation of GAAP to Non-GAAP Measures (unaudited):


(Dollars in thousands)
 		March 31, 2023   December 31, 2022   March 31, 2022
           
Tangible book value per share          
Total shareholders’ equity $ 54,609     $ 59,583     $ 62,683  
Goodwill   (1,107 )     (1,107 )     (1,107 )
Core deposit intangible, net   (238 )     (249 )     (284 )
Tangible book value $ 53,264     $ 58,227     $ 61,292  
           
Shares outstanding   3,965,186       3,965,186       3,956,492  
Tangible book value per share $ 13.43     $ 14.68     $ 15.49  
           
Tangible book value excluding other comprehensive loss per share          
Tangible book value $ 53,264     $ 58,227     $ 61,292  
Other comprehensive loss   14,398       15,645       7,119  
Tangible book value excluding other comprehensive loss $ 67,662     $ 73,872     $ 68,411  
           
Shares outstanding   3,965,186       3,965,186       3,956,492  
Tangible book value excluding other comprehensive loss per share $ 17.06     $ 18.63     $ 17.29  

Contacts:    
Patriot Bank, N.A. Joseph Perillo David Lowery
900 Bedford Street Chief Financial Officer President & CEO
Stamford, CT 06901 203-252-5954 203-252-5959
www.BankPatriot.com    



Posted on

Pinterest to participate in the J.P. Morgan Global Technology, Media and Communications Conference

Pinterest to participate in the J.P. Morgan Global Technology, Media and Communications Conference

SAN FRANCISCO–(BUSINESS WIRE)–
Pinterest, Inc. (NYSE: PINS) announced today that Bill Ready, CEO will participate in the J.P. Morgan Global Technology, Media and Communications Conference. The session is scheduled for May 23, 2023 at 7:10 AM PST (10:10 AM EST).

A live webcast will be publicly available on Pinterest’s Investor Relations website at investor.pinterestinc.com. An archived copy of the webcast will be available on the same website for 30 days following the completion of the event.

Disclosure Information

Pinterest uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the company’s Investor Relations website, in addition to following the company’s press releases, SEC filings, public conference calls, presentations and webcasts.

About Pinterest

Pinterest is the daily visual inspiration platform people around the world use to shop products personalized to their taste, find ideas to do offline and discover the most inspiring content. People have saved more than 390 billion Pins across a range of interests from building a home office to cooking a new recipe and planning a vacation. Headquartered in San Francisco, Pinterest launched in 2010 and has more than 460 million monthly active users worldwide. Available on iOS and Android, and at pinterest.com.

Press

Tessa Chen

[email protected]

Investor Relations

Neil Doshi

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Communications Social Media Technology Photography Audio/Video Software Internet

MEDIA:

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Posted on

Westlake Corporation Declares Quarterly Dividend

Westlake Corporation Declares Quarterly Dividend

$0.357 per share dividend declared payable on June 8, 2023

HOUSTON–(BUSINESS WIRE)–
The Board of Directors of Westlake Corporation (NYSE:WLK) declared today a regular dividend distribution of $0.357 per share for the first quarter of 2023. This dividend will be payable on June 8, 2023, to stockholders of record on May 23, 2023.

This is the 75th successive quarterly dividend that Westlake has declared since completing its initial public offering in August 2004.

About Westlake

Westlake is a global manufacturer and supplier of materials and innovative products that enhance life every day. Headquartered in Houston, with operations in Asia, Europe and North America, we provide the building blocks for vital solutions — from housing and construction, to packaging and healthcare, to automotive and consumer. For more information, visit the Company’s web site at www.westlake.com.

Media Inquiries:

Westlake Corp.

Ben Ederington, 713-960-9111

or

Investor Inquiries:

Westlake Corp.

Steve Bender, 713-960-9111

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Chemicals/Plastics Other Construction & Property Manufacturing Construction & Property Other Manufacturing Textiles

MEDIA:

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Posted on

Procaps Group Reports Fourth Quarter and Full Year 2022 Results

Procaps Group Reports Fourth Quarter and Full Year 2022 Results

Constant Currency Net Revenues Increased 7% Year-over-Year in 2022, With Strong Demand of RX and Softgel Portfolios, Offset by Clinical Specialty Covid Portfolio

Preliminary Results for 1Q23 Show a Significant Rebound from 4Q22 Performance, Company Expects to Reach at Least High Single-Digit Growth in Adjusted EBITDA

Management Reaffirms Preliminary FY2023 Net Revenue and Adjusted EBITDA Guidance

Multiple Value-Creation Initiatives Implemented and On Track to Achieve Up to $15 million of Targeted Recurring Savings

Company to Host Conference Call and Webcast Monday, May 15, 2023 at 10:00am Eastern Time

MIAMI & BARRANQUILLA, Colombia–(BUSINESS WIRE)–
Procaps Group S.A. (NASDAQ: PROC) (“Procaps”), a leading integrated international healthcare and pharmaceutical services company, today announced its financial results for the three months ended December 31, 2022 (“4Q22”) and full fiscal year ended December 31, 2022 (“2022”).

“Demand remains robust for RX and consumer health products as well as for all our CDMO products and services. We are executing our value creation initiatives as we build a solid foundation and transition toward new paths for growth,” said Rubén Minski, CEO of Procaps.

Highlights 2022 & 4Q22

Product Development & Market Expansion

  • Packaging services started at our new gummy manufacturing facility in Florida. Full gummies production expected to commence in 2H23

  • Commencement of operations at our West Palm Beach facility providing R&D services

  • Renewal rate of 27% in 2022

  • Execution of Value Creation Initiatives on track

Financial Highlights

  • Net revenues totaled $101 million for 4Q22, a decrease of 11% in constant currency, impacted mainly by currency devaluation and a decrease in our Covid-related products in our Clinical Specialties line. Net revenues totaled $410 million in 2022, an increase of 7% on a constant currency basis.

  • Gross profit for 4Q22 totaled $52 million, with a 51% gross margin. Gross profit totaled $240 million for 2022, with a 58% gross margin.

4Q22

 

4Q21

 

Δ%

 

2022

 

2021

 

Δ%

Net Revenues

101.5

126.5

-19.8%

409.9

409.7

0.0%

COGS

(49.2)

(50.9)

-3.3%

(170.4)

(174.0)

-2.1%

Gross Profit

52.3

75.7

-30.9%

239.6

235.7

1.6%

Gross Margin

51.5%

59.8%

-829.3 bps

58.4%

57.5%

91.6 bps

Average FX USD/COP

4,808.0

3,879.0

23.9%

4,255

3,743

13.7%

FY 2023 Net Revenue and Adjusted EBITDA Guidance

 

2023 Constant Currency

2022

Net Revenues

  

~+10%

$410M

Adjusted EBITDA

  

$90- $100M

$70M

1Q23 Preliminary Results Highlights

 

1Q23

1Q22

Net Revenues

  

$82M – $85M

$86 M

FX Impact on Net Revenues

  

$7M

–

Constant Net Revenues

  

$89M – $92M

–

Constant Adj. EBITDA

  

~ $10M

 

Procaps Chief Executive Officer, Ruben Minski, added:

“Looking to the remainder of 2023, we continue to expect the impact of many of these recent issues to subside. We believe momentum will expand as we benefit significantly from the investments in capabilities, products and geographies we have made over the last few years. Combined with our cost reduction plans to optimize our business in the near term, without compromising our long-term objectives, we continue to expect to grow net revenues at approximately 10%+ in 2023 on a constant currency basis and are forecasting our Adjusted EBITDA range to be approximately $90-100 million.”

Management Commentary

Procaps Chief Executive Officer, Ruben Minski, commented:

“2022 was underlined by strong demand for our existing product line including RX and consumer health products that helped overcome challenges in several areas. RX products grew approximately 21% year over year. We also maintained our rapid pace with innovative new product launches and expansion into new regions. We have continued to grow on a constant currency basis, supporting our strategic investments in capabilities, products and geographies over the last few years.

“2022 was also affected by multiple macroeconomic headwinds including significant currency devaluation in the markets where we operate, supply chain disruptions, rapid cost inflation and post pandemic demand price adjustments. As the currency headwinds and macro issues impacting us subside, we believe we have put in place a long-term strategy with the competitive advantages that will position us for ongoing success. This strategy is complemented by an aggressive plan to reduce expenses and generate the efficiencies that we implemented at the beginning of 2023.

“The strong cadence of new product launches and product rollouts to new regions combined to deliver 7% revenue growth on a constant currency basis for the full year 2022, despite the previously mentioned headwinds, and is positioning us to build a strong foundation for 2023. With our strong focus on continuous innovation and internationalization, we continue to expand our portfolio within selected therapy areas and geographies, with approximately $111 million net sales coming from new products in 2022. In addition, we have over 170 products pending approval to be launched in the next few years.

“As I mentioned before, we have implemented multiple value-creation initiatives to reduce costs, improve margins and near-term profitability, as well as to expand our global reach with our roll-up strategy and to fund our growth objectives. The goal is to achieve up to $15 million of recurring savings to be realized over the next 18 months. Since the beginning of this year, we have been focused on these initiatives, including headcount right-sizing, SG&A efficiency, R&D optimization, and corporate expenses efficiency. As of March 2023, total execution of our savings capture rate was approximately 20%, and preliminary accumulated savings results from these efforts were $3.0 million.

“Looking ahead in 2023, we expect to see continuing challenges and uncertainties, such as a possible recession in the United States and Europe, supply chain disruptions, significant volatility of the currencies in the markets where we operate, as well as high interest rates and tight financial markets in general. However, with our focus on our strengths for growth and the substantial efforts we’re putting in our strategic improvement initiatives, I’m confident that we are well positioned to achieve our near and long-term goals. We expect 2023 to be a year to stabilize and improve our results so we can continue with our expansion plans,” concluded Minski.

Procaps Chief Financial Officer, Patricio Vargas, commented:

“We ended the fourth quarter of 2022 with a revenue decrease of 11% over the same period of the previous year, and an increase of 7% for the full year, both on a constant currency basis. Significant currency devaluation in the markets where we operate, supply chain disruptions and rapid cost inflation disproportionately and negatively impacted our usually strong fourth quarter. We also saw distributors reducing Covid-19 related inventories, which negatively impacted our sales in the last months of the year. As we move into 2023, we believe our strong demand growth and value creation initiatives will position us to recover from the negative impacts we suffered in 2022.

“The strong currency devaluation during the last few months in some of our markets, and especially in the last quarter, negatively impacted our net revenues by $12 million compared to the fourth quarter of 2021 and by $28 million in the full year compared to the same period in the prior year.

“Despite these negative impacts our gross margin remained robust at 58% for 2022, slightly higher than 2021.

“We want to take this opportunity to apologize to our shareholders for being delayed in our 2022 filing. We recognize it is bad news and we’re working hard to solve our issues. We expected our new consolidation system to be in place by now, but we were delayed and are now expecting it to be operational with respect to our second quarter filing. At the same time, we continue working on remediating our material weaknesses, which we expect should be mostly addressed within the next 18 months,” concluded Vargas.

Please check Procaps investor relations website for full Earning Release details, at: https://investor.procapsgroup.com/financials/quarterly-reports.

Conference Call Information:

The Company expects to host a conference call and webcast on Monday, May 15th, at 10am Eastern time.

To access the call, please use the following information:

Date: Monday, May 15, 2023

Time: 10 a.m. ET

Toll Free dial-in number: 1-844-204-8586

Toll/International dial-in number: 1-412-317-6346

Procaps HD Phone: https://hd.choruscall.com/?$Y2FsbHR5cGU9MiZyPXRydWUmaW5mbz1waG9uZS1jb21wYW55

Conference ID: Procaps Group

The conference call will be broadcast live and available for replay at https://webcastlite.mziq.com/cover.html?webcastId=c1db710b-4949-463c-9079-ae5991d29b9f and via the investor relations section of Procaps’ website.

About Procaps Group

Procaps Group, S.A. (“Procaps”) (NASDAQ: PROC) is a developer of pharmaceutical and nutraceutical solutions, medicines, and hospital supplies that reach more than 50 countries in all five continents. Procaps has a direct presence in 13 countries in the Americas and more than 5,500 employees working under a sustainable model. Procaps develops, manufactures, and markets over the counter (OTC) pharmaceutical products and prescription pharmaceutical drugs (Rx), nutritional supplements and high-potency clinical solutions. For more information, visit www.procapsgroup.com or Procaps Group’s investor relations website investor.procapsgroup.com.

Use of Non-IFRS Financial Measures

Our management uses and discloses EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, Net Debt-to-Adjusted EBITDA ratio, Contribution Margin and net revenue on a constant currency basis, which are non-IFRS financial information to assess our operating performance across periods and for business planning purposes. We believe the presentation of these non-IFRS financial measures is useful to investors as it provides additional information to facilitate comparisons of historical operating results, identify trends in our underlying operating results and provide additional insight and transparency on how we evaluate our business. These non-IFRS measures are not meant to be considered in isolation or as a substitute for financial information presented in accordance with International Financial Reporting Standards (“IFRS”) issued by the International Accounting Standards Board and should be viewed as supplemental and in addition to our financial information presented in accordance with IFRS.

EBITDA, Adjusted EBITDA, Adjusted EBITDA Margin and Net Debt-to- Adjusted EBITDA ratio

We define EBITDA as profit (loss) for the period before interest expense, net, income tax expense and depreciation and amortization. We define Adjusted EBITDA as EBITDA further adjusted to exclude certain isolated costs incurred as a result of the COVID-19 pandemic, certain transaction costs incurred in connection with the business combination (“Business Combination”) with Union Acquisition Corp. II (“Union”), certain listing expenses incurred in connection with the Business Combination, certain costs related to business transformation initiatives, certain foreign currency translation adjustments and certain other finance costs, and other nonrecurring nonoperational or unordinary items as the Company may deem appropriate from time to time. We also report Adjusted EBITDA as a percentage of net revenue as an additional measure so investors may evaluate our Adjusted EBITDA margins. None of EBITDA, Adjusted EBITDA or Adjusted EBITDA margin are presented in accordance with generally accepted accounting principles (“GAAP”) or IFRS and are non-IFRS financial measures.

We use EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, and Net Debt-to-Adjusted EBITDA ratio for operational and financial decision-making and believe these measures are useful in evaluating our performance because they eliminate certain items that we do not consider indicators of our operating performance. EBITDA, Adjusted EBITDA, Adjusted EBITDA margin and Net Debt-to-Adjusted EBITDA ratio are also used by many of our investors and other interested parties in evaluating our operational and financial performance across reporting periods. We believe that the presentation of EBITDA, Adjusted EBITDA, Adjusted EBITDA margin and Net Debt-to- Adjusted EBITDA ratio provides useful information to investors by allowing an understanding of key measures that we use internally for operational decision-making, budgeting, evaluating acquisition targets, and assessing our operating performance.

EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, and Net Debt-to- Adjusted EBITDA ratio are not recognized terms under IFRS and should not be considered as a substitute for net income (loss), cash flows from operating activities, or other income or cash flow statement data. These measures have limitations as analytical tools and should not be considered in isolation or as substitutes for analysis of our results as reported under IFRS. We strongly encourage investors to review our financial statements in their entirety and not to rely on any single financial measure.

Because non-IFRS financial measures are not standardized, EBITDA, Adjusted EBITDA, Adjusted EBITDA margin, and Net Debt-to-Adjusted EBITDA ratio, as defined by us, may not be comparable to similarly titled measures reported by other companies. It, therefore, may not be possible to compare our use of these non-IFRS financial measures with those used by other companies.

The Company is not able to reconcile its forward-looking non-IFRS estimates of Adjusted EBITDA presented in this press release for the year ending December 31, 2023, without unreasonable effort because of the inherent difficulty of accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliation that have not yet occurred, are out of our control, or cannot be reasonably predicted, which could have a material impact on its future IFRS financial results.

Forward-Looking Statements

This press release includes “forward-looking statements.” Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include projected financial information. Such forward-looking statements with respect to revenues, earnings, performance, strategies, synergies, prospects, and other aspects of the businesses of Procaps are based on current expectations that are subject to risks and uncertainties. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to: (1) whether the Company enters into a new definitive agreement with respect to an acquisition of, and if so, the inability to recognize the anticipated benefits of any such potential acquisition of Al Soar (Netherlands) BV (“Somar Holding”), Química y Farmacia S.A. de C.V. (“Quífa”), PDM Acondifarma S.A. de C.V. (“PDM”), Gelcaps Exportadora de Mexico S.A. de C.V. (“Gelcaps”), and Grupo Farmacéutico Somar S.A.P.I. de C.V. (“Somar”, and together with Somar Holding, Quífa, PDM and Gelcaps, collectively, “Grupo Somar”) which may be affected by, among other things, competition, and the ability of the combined business to grow and manage growth profitably, or of any merger or acquisition contemplated by the Company; (2) the inability to successfully retain or recruits officers, key employees, or directors; (3) effects on Procaps’ public securities’ liquidity and trading; (4) the lack of a market for Procaps’ securities; (5) changes in applicable laws or regulations; (6) the possibility that Procaps may be adversely affected by other economic, business, and/or competitive factors; (7) the Company’s inability to achieve its cost saving goals and value creating initiatives, (8) our ability to remediate our disclosed material weaknesses within certain time frames, if at all and (9) other risks and uncertainties indicated from time to time in documents filed or to be filed with the Securities and Exchange Commission (“SEC”) by Procaps. Accordingly, forward-looking statements, including any projections or analysis, should not be viewed as factual and should not be relied upon as an accurate prediction of future results. The forward-looking statements contained in this presentation are based on our current expectations and beliefs concerning future developments and their potential effects on Procaps. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the ability to recognize the anticipated benefits of any acquisitions contemplated or pursued by the Company, the impact of COVID-19 on Procaps’ business, changes in applicable laws or regulations, the possibility that Procaps may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those included under the header “Risk Factors” in Procaps’ annual report on Form 20-F filed with the SEC, as well as Procaps’ other filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, you should not put undue reliance on these statements.

Investor Contact:

Melissa Angelini

[email protected]

+1 754 260-6476

KEYWORDS: Florida United States South America Colombia North America

INDUSTRY KEYWORDS: General Health Pharmaceutical Health

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Western Digitalto Participate in Upcoming Investor Conference

Western Digitalto Participate in Upcoming Investor Conference

SAN JOSE, Calif.–(BUSINESS WIRE)–
Western Digital Corp. (NASDAQ: WDC) today announced management participation in the following upcoming investor conference:

Event: J.P. Morgan 51st Annual Global Technology, Media and Communications Conference

Date: Monday, May 22, 2023 at 6:20 a.m. PT / 9:20 a.m. ET

The management presentation will be available as a live webcast, accessible through Western Digital’s Investor Relations website at investor.wdc.com. An archived replay will be accessible through the website shortly after the conclusion of the presentation.

About Western Digital

Western Digital is on a mission to unlock the potential of data by harnessing the possibility to use it. With Flash and HDD franchises, underpinned by advancements in memory technologies, we create breakthrough innovations and powerful data storage solutions that enable the world to actualize its aspirations. Core to our values, we recognize the urgency to combat climate change and have committed to ambitious carbon reduction goals approved by the Science Based Targets initiative. Learn more about Western Digital and the Western Digital®, SanDisk® and WD® brands at www.westerndigital.com.

© 2023 Western Digital Corporation or its affiliates. All rights reserved.

Western Digital Corp.

Investor Contact:

T. Peter Andrew

949.672.9655

[email protected]

[email protected]

Media Contact:

Robin Schultz

408.573.5043

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Semiconductor Data Management Consumer Electronics Technology Other Technology Hardware

MEDIA:

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Precision BioSciences Announces Publication of its Preclinical In Vivo Gene Editing Abstract on Duchenne Muscular Dystrophy Program for the American Society of Gene & Cell Therapy 26th Annual Meeting

Precision BioSciences Announces Publication of its Preclinical In Vivo Gene Editing Abstract on Duchenne Muscular Dystrophy Program for the American Society of Gene & Cell Therapy 26th Annual Meeting

Late-Breaking Abstract Demonstrates Capabilities of ARCUS for Large Gene Excision In Vivo

DURHAM, N.C.–(BUSINESS WIRE)–
Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced that its late-breaking abstract presenting preclinical in vivo gene editing data for its PBGENE-DMD program, being developed for the potential treatment of Duchenne muscular dystrophy (DMD), is available through the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting website at https://annualmeeting.asgct.org/abstracts/abstract-details?abstractId=15227.

An oral presentation, ARCUS-Mediated Excision of the “Hot Spot” Region of the Human Dystrophin Gene for the Treatment of Duchenne Muscular Dystrophy (DMD), will be presented as part of the Late-breaking Abstracts 2 Session on May 19, 2023.

About ARCUS

ARCUS is a proprietary genome editing technology discovered and developed by scientists at Precision BioSciences. It uses sequence-specific DNA-cutting enzymes, or nucleases, that are designed to either insert (knock-in), excise (knock-out), or repair DNA of living cells and organisms. ARCUS is based on a naturally occurring genome editing enzyme, I-CreI, that evolved in the algae Chlamydomonas reinhardtii to make highly specific cuts in cellular DNA and stimulate gene insertion at the cut site by homologous recombination. Precision’s platform and products are protected by a comprehensive portfolio including nearly 100 patents to date.

About DMD

DMD is a genetic disorder associated with mutations in the dystrophin gene that prevent production of the dystrophin protein. Dystrophin stabilizes the cell membrane during muscle contraction to prevent damage, and the absence of intact dystrophin protein leads to inflammation, fibrosis, and progressive loss of muscle function and mass. Over time, children with DMD will develop problems walking and breathing, eventually leading to death in the second or third decade of life due to progressive cardiomyopathy and respiratory insufficiency. DMD occurs in 1 in 3,500 to 5,000 male births, and currently there are limited approved therapies available for patients.

About Precision BioSciences, Inc.

Precision BioSciences, Inc. is a clinical stage biotechnology company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform. ARCUS is a highly precise and versatile genome editing platform that was designed with therapeutic safety, delivery, and control in mind. Using ARCUS, the Company’s pipeline consists of several in vivo gene editing candidates designed to cure genetic and infectious diseases where no adequate treatments exist and multiple ex vivo clinical candidates. For more information about Precision BioSciences, please visit www.precisionbiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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, statements regarding expected conference participation and disclosure of preclinical data, the clinical development, nomination, and goals of our PBGENE-DMD program, and therapeutic potential of an ARCUS gene editing approach for the treatment of DMD. In some cases, you can identify forward-looking statements by terms such as “aim,” “anticipate,” “approach,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “goal,” “intend,” “look,” “may,” “mission,” “plan,” “possible,” “potential,” “predict,” “project,” “pursue,” “should,” “target,” “will,” “would,” or the negative thereof and similar words and expressions.

Forward-looking statements are based on management’s current expectations, beliefs and assumptions and on information currently available to us. Such statements are neither promises nor guarantees, but involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, the important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors page of our website under SEC Filings at investor.precisionbiosciences.com.

All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor and Media Contact:

Mei Burris

Director, Investor Relations and Finance

[email protected]

KEYWORDS: North Carolina United States North America

INDUSTRY KEYWORDS: Biotechnology Health General Health Pharmaceutical Oncology Other Science Research Infectious Diseases Genetics Science Clinical Trials

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Aligos Therapeutics Announces Research Collaboration and Development Agreement with Xiamen Amoytop Biotech Co. Ltd. for Use of Aligos’ Oligonucleotide Platform for the Treatment of Liver Diseases

SOUTH SAN FRANCISCO, Calif., May 12, 2023 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, the “Company”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a research collaboration and development agreement with Xiamen Amoytop Biotech Co. Ltd. (“Amoytop”) for the use of Aligos’ oligonucleotide platform to discover, research and develop oligonucleotides for the treatment of liver diseases in the Greater China territory.

Under the terms of the agreement, Aligos and Amoytop will collaborate on the research and development of oligonucleotide compounds for the treatment of liver diseases. Amoytop will receive an option to obtain an exclusive license to develop and commercialize the resultant products in the Greater China territory while Aligos will retain rest-of-world rights. Aligos will also receive an upfront payment and research collaboration funding and be eligible to receive up to a total of $109 million in development and sales milestone payments for licensed products as well as tiered royalties on net sales. 

“We are pleased to begin our collaboration with Amoytop, a leading Chinese domestic pharmaceutical company developing innovative therapies for liver diseases,” said Lawrence Blatt, Ph.D., MBA, Chairman & CEO of Aligos. “Our team has remained committed to developing drug candidates with the potential to improve the lives of patients living with viral and liver diseases, and we believe this research collaboration will help us to move closer to achieving that goal.”

Sun Li, Chairman & CEO at Amoytop added, “We believe Aligos’ oligonucleotide platform has the potential to help our teams discover and develop novel candidates for liver diseases in China. We look forward to working together to advance new treatment options for patients in need.”

About Aligos

Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver diseases and viral infections. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best in class therapeutics for nonalcoholic steatohepatitis (NASH) and viruses with high unmet medical need such as coronaviruses and chronic hepatitis B (CHB).

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements”, including without limitation, statements around the possibility of receiving up to a total of $109 million in development and sales milestone payments for licensed products as well as tiered royalties on net sales, Aligos’ belief that the research collaboration will help the Aligos team move closer to achieving the goal of developing drug candidates with the potential to improve lives of patients living with viral and liver diseases and the belief that Aligos’ oligonucleotide platform has the potential to help discover and develop novel candidates for liver diseases in China. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’ ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 4, 2023 and its future periodic reports to be filed with or submitted to the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

Media Contact

Amy Jobe, Ph.D.
LifeSci Communications
+1 315 879 8192
[email protected]

Investor Contact

Corey Davis, Ph.D.
LifeSci Advisors
+1 212 915 2577
[email protected]