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DoubleVerify Announces Launch of Secondary Offering by Selling Stockholders

DoubleVerify Announces Launch of Secondary Offering by Selling Stockholders

NEW YORK–(BUSINESS WIRE)–
DoubleVerify Holdings, Inc. (NYSE: DV) (“DoubleVerify”) today announced the launch of an underwritten offering of 12,500,000 shares of its common stock by Providence VII U.S. Holdings L.P. and Providence Butternut Co-Investment L.P. (collectively, “Providence”). The shares will be offered to the public at a fixed price, which may be changed at any time without notice. The underwriters will have a 30-day option to purchase up to an additional 1,875,000 shares of common stock from Providence. DoubleVerify will not receive any proceeds from the sale of shares in the offering.

Goldman Sachs & Co. LLC and Barclays are acting as the underwriters in the offering.

The offering of common stock is being made only by means of a prospectus supplement and accompanying prospectus. Copies of the prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by facsimile at (212) 902-9316, or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847, or by email at [email protected].

A registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission on September 30, 2022 and became effective automatically. The registration statement may be obtained free of charge at the SEC’s website at www.sec.gov under “DoubleVerify Holdings, Inc.” This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About DoubleVerify

DoubleVerify is a leading software platform for digital media measurement and analytics. Our mission is to make the digital advertising ecosystem stronger, safer and more secure, thereby preserving the fair value exchange between buyers and sellers of digital media. Hundreds of Fortune 500 advertisers employ our unbiased data and analytics to drive campaign quality and effectiveness, and to maximize return on their digital advertising investments – globally.

Forward-Looking Statements

This press release includes “forward-looking statements,” including with respect to the proposed secondary offering. Forward-looking statements are subject to known and unknown risks and uncertainties, many of which may be beyond our control. We caution you that the forward-looking information presented in this press release is not a guarantee of future events, and that actual events may differ materially from those made in or suggested by the forward-looking information contained in this press release. In addition, forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “plan,” “seek,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe” or “continue” or the negative thereof or variations thereon or similar terminology. Any forward-looking information presented herein is made only as of the date of this press release, and we do not undertake any obligation to update or revise any forward-looking information to reflect changes in assumptions, the occurrence of unanticipated events, or otherwise.

Investor Relations

Tejal Engman

DoubleVerify

[email protected]

Media

Chris Harihar

Crenshaw Communications

646-535-9475

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Software Technology Data Analytics Professional Services

MEDIA:

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Merus Announces Financial Results for the Second Quarter 2023 and Provides Business Update

– Petosemtamab granted Fast Track Designation for the treatment of patients with recurrent or metastatic head & neck squamous cell carcinoma

– Phase 3 trial of petosemtamab monotherapy in previously treated (2L/3L) head and neck squamous cell carcinoma planned to initiate in mid-2024

– Zeno granted two Breakthrough Therapy Designations in NRG1 fusion (NRG1+) non-small cell lung and pancreatic cancer

– Based on the Company’s current operating plan, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2026

UTRECHT, The Netherlands and CAMBRIDGE, Mass., Aug. 07, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), today announced financial results for the second quarter and provided a business update.

“Receiving Fast Track Designation is an important milestone for petosemtamab, which we believe further validates its potential to address the unmet need of patients with previously treated recurrent or metastatic head and neck cancer,” said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. “We also believe the robust clinical data observed in previously treated HNSCC support a phase 3 trial of petosemtamab monotherapy in this setting, which could potentially start in mid-2024. Additionally, we are encouraged by our progress to date with the combination of petosemtamab and Keytruda® as potential front-line therapy in advanced HNSCC, and are evaluating a phase 3 trial in this setting as well.”


Petosemtamab (MCLA-158: EGFR x LGR5 Biclonics®): Solid Tumors


Granted Fast Track Designation (FTD)
for the treatment of patients with recurrent or metastatic head & neck squamous cell carcinoma (HNSCC), enrollment continues in dose expansion in the phase 1/2 trial with petosemtamab monotherapy in previously treated HNSCC, as well as in combination with Keytruda® (pembrolizumab) as front-line therapy.

Petosemtamab is in clinical development in the expansion part of a phase 1/2 open-label, multicenter trial evaluating petosemtamab monotherapy in patients with advanced solid tumors, including previously treated (recurrent or metastatic) HNSCC. Enrollment is also ongoing in a cohort investigating petosemtamab in combination with Keytruda® in patients with untreated HNSCC to evaluate the safety and clinical activity in this population. Merus plans to report initial interim clinical data from this cohort in the first half of 2024.   

Initiation of potential registration-enabling trial

Merus is enrolling up to a total of approximately 40 patients in previously treated (2L/3L) HNSCC with petosemtamab monotherapy at the 1100 or 1500 mg dose levels to confirm a suitable dose for future randomized trials. Based on these data and additional information and analyses, Merus anticipates potentially initiating a randomized phase 3 trial of petosemtamab monotherapy, or investigators’ choice of single agent chemotherapy or cetuximab in 2L/3L HNSCC. Merus anticipates such a trial could potentially start in mid-2024. Merus believes a randomized registration trial in HNSCC with an overall response rate (ORR) endpoint could potentially support accelerated approval and the overall survival (OS) results from the same study could potentially verify its clinical benefit to support regular approval.

Merus is also evaluating a phase 3 trial investigating petosemtamab with Keytruda® as a potential front-line therapy for advanced HNSCC expressing PD-L1 (CPS > 1), pending analysis of additional data on the tolerability and safety of the drug combination.

Fast Track Designation

The U.S. Food & Drug Administration (FDA) has granted FTD for petosemtamab for the treatment of patients with recurrent or metastatic HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-programmed cell death protein 1 (anti-PD-1) antibody.  

FTD is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs.

Interim data from AACR

In April, Merus provided an interim clinical update at the American Association for Cancer Research (AACR) Annual Meeting 2023. As of a February 1, 2023 data cutoff date, 49 previously treated HNSCC patients were treated with petosemtamab at the initial recommended phase 2 dose of 1500 mg intravenously every two weeks. The ORR, in 43 evaluable patients, was 37.2% by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. per investigator assessment. Median duration of response was 6.0 months and median progression free survival was 5.3 months. 63% of responders had an ongoing response at the data cutoff date. Median OS was 11.5 months. Petosemtamab continued to demonstrate a manageable safety profile. 


Zenocutuzumab (Zeno or MCLA-128: HER2 x HER3 Biclonics®): NRG1 fusion (NRG1+) cancer and other solid tumors


Granted Breakthrough Therapy Designation (BTD) for both NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer; enrollment continues in the eNRGy trial of Zeno monotherapy in NRG1+ cancer and a phase 2 trial of Zeno in combination with androgen deprivation therapy (ADT) in castration resistant prostate cancer (CRPC); as well as in combination with afatinib in NRG1+ non-small cell lung cancer (NSCLC)

The FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options. Additionally, the FDA has granted BTD to Zeno for the treatment of patients with advanced unresectable or metastatic NRG1+ NSCLC, following progression with prior systemic therapy. Zeno is being investigated in the phase 1/2 eNRGy trial and Early Access Program (EAP) which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer (Phase 1/2: NCT02912949, EAP: NCT04100694).

As of June 2023, more than 175 patients with NRG1+ cancer have been treated with Zeno monotherapy. The company continues to work with the FDA and is focused on accumulating data to support a potential Biologics License Application.

Merus believes that obtaining a commercialization partnership agreement will be an essential step in bringing Zeno to patients with NRG1+ cancer, if approved.

Merus plans to present a clinical update on Zeno in NRG1+ cancer at the European Society for Medical Oncology (ESMO) 2023 taking place in Madrid, Spain October 20-24, 2023. The presentations will consist of a mini-oral lecture titled: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC) and a poster presentation titled: Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC).

Further, Merus is evaluating Zeno in combination with an ADT (enzalutamide or abiraterone) in men with CRPC, irrespective of NRG1+ status. Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023.

Merus is also evaluating Zeno in combination with afatinib in patients with NRG1+ NSCLC.


MCLA-129 (EGFR x c-MET Biclonics®): Solid Tumors


Enrollment continues in the expansion cohorts in the phase 1/2 trial; clinical update planned for 2H23

MCLA-129 is in clinical development in a phase 1/2, open-label clinical trial evaluating MCLA-129 monotherapy in patients with EGFR ex20 NSCLC, MET ex14 NSCLC, and in HNSCC, as well as MCLA-129 in combination with Tagrisso®, a third generation EGFR TKI, in patients with treatment-naïve EGFR mutant (m) NSCLC and in patients with EGFRm NSCLC that have progressed on Tagrisso®.

In April, Merus provided a pre-clinical presentation of MCLA-129 in comparison with amivantamab at the AACR Annual Meeting 2023. The Company plans to provide an initial clinical data update from the expansion cohorts, and a further clinical development strategy update in the second half of 2023.

MCLA-129 is subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains global rights outside of China.

In July, the National Medical Products Administration in China approved the investigational new drug application permitting Betta to investigate the combination of MCLA-129 and befotertinib, a third generation EGFR tyrosine kinase inhibitor, in adult patients in China that have locally advanced or metastatic NSCLC, with an EGFR Exon 19 deletion mutation or Exon 21 (L858R) substitution mutation.


MCLA-145 (CD137 x PD-L1 Biclonics®): Solid Tumors


Enrollment continues in the phase 1 trial, including in combination with Keytruda® (pembrolizumab),
a PD-1 inhibitor

MCLA-145 is in clinical development in a global, phase 1, open-label, clinical trial evaluating MCLA-145 in patients with solid tumors. The trial is in the dose expansion phase evaluating the combination of MCLA-145 with Keytruda®, with enrollment ongoing.


Collaborations


Incyte Corporation

Since 2017, Merus has been working with Incyte Corporation (Incyte) under a global collaboration and license agreement focused on the research, discovery and development of bispecific antibodies utilizing Merus’ proprietary Biclonics® technology platform. The agreement grants Incyte certain exclusive rights for up to ten bispecific and monospecific antibody programs. The collaboration is progressing, with multiple programs in various stages of preclinical and clinical development. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved. Further, Incyte announced, in 2023, that INCA33890, a novel TGFBr2xPD1 bispecific antibody developed through the collaboration is currently being evaluated in clinical studies. In July 2023, Merus achieved a milestone and expects a payment of $2.5 million related to the advancement of this program in the third quarter of 2023.


Loxo Oncology at Lilly


In January 2021, Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly), announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies utilizing Merus’ Biclonics® platform and proprietary CD3 panel along with the scientific and rational drug design expertise of Loxo Oncology at Lilly. The collaboration is progressing with multiple active research programs underway.


Cash Runway, existing cash, cash equivalents and marketable securities expected to fund Merus’ operations into 2026


As of June 30, 2023, Merus had $311.5 million cash, cash equivalents and marketable securities. Based on the Company’s current operating plan, the existing cash, cash equivalents and marketable securities are expected to fund Merus’ operations into 2026.


Second Quarter 2023 Financial Results

We ended the second quarter with cash, cash equivalents and marketable securities of $311.5 million compared to $326.7 million at December 31, 2022.

Collaboration revenue for the three months ended June 30, 2023 decreased by $2.2 million as compared to the three months ended June 30, 2022, primarily as a result of decreases in reimbursement revenue of $0.5 million, milestone revenue of $1.0 million and amortization of deferred revenue of $0.7 million.

Research and development expense for the three months ended June 30, 2023 decreased by $2.8 million as compared to the three months ended June 30, 2022, primarily as a result of decreases in external clinical services and drug manufacturing costs, including costs to fulfill our obligations under our collaboration agreements, related to our programs of $3.8 million and a decrease in facilities costs of $0.5 million, partially offset by an increase in personnel related expenses including stock-based compensation of $1.5 million due to an increase in employee headcount.

General and administrative expense for the three months ended June 30, 2023 increased by $3.4 million as compared to the three months ended June 30, 2022, primarily as a result of increases in facilities costs including depreciation of $1.6 million, consulting costs of $1.2 million, IP and license costs of $0.4 million, and travel expenses of $0.4 million, partially offset by a decrease in finance and human resources costs of $0.2 million.

Collaboration revenue for the six months ended June 30, 2023 decreased by $0.3 million as compared to the six months ended June 30, 2022, primarily as a result of a decrease in reimbursement revenue of $0.9 million, decrease of amortization of deferred revenue of $0.9 million partially offset by an increase in milestone revenue of $1.5 million.

Research and development expense for the six months ended June 30, 2023 increased by $5.1 million as compared to the six months ended June 30, 2022, primarily as a result of increases in personnel related expenses including stock-based compensation of $3.7 million, external clinical services and drug manufacturing costs, including costs to fulfill our obligations under our collaboration agreements, related to our programs of $1.6 million, consulting expenses of $0.6 million, and consumables expenses of $0.3 million and travel costs of $0.2 million, partially offset by decreases in facilities costs of $0.8 million and partner expenses of $0.5 million. General and administrative expense for the six months ended June 30, 2023 increased by $7.0 million as compared to the six months ended June 30, 2022, primarily as a result of increases in consulting costs of $3.6 million, facilities costs including depreciation of $2.8 million, travel costs of $0.6 million, personnel related expenses including stock-based compensation of $0.5 million due to an increase in employee headcount, and IP and license costs of $0.3 million, partially offset by decreases in finance and human resources costs of $0.8 million.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.

MERUS N.V.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(Amounts in thousands, except per share data)
           
  June 30,

2023 		    December 31,

2022 		 
ASSETS          
Current assets:          
Cash and cash equivalents $ 101,096     $ 147,749  
Marketable securities   163,950       142,480  
Accounts receivable   2,836       4,051  
Prepaid expenses and other current assets   15,243       12,163  
Total current assets   283,125       306,443  
Marketable securities   46,501       36,457  
Property and equipment, net   13,049       12,222  
Operating lease right-of-use assets   11,946       12,618  
Intangible assets, net   1,882       1,950  
Deferred tax assets   3,057       2,041  
Other assets   4,064       4,811  
Total assets $ 363,624     $ 376,542  
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable $ 7,596     $ 9,834  
Accrued expenses and other liabilities   31,143       35,590  
Income taxes payable   1,349       2,400  
Current portion of lease obligation   1,610       1,684  
Current portion of deferred revenue   24,151       29,418  
Total current liabilities   65,849       78,926  
Lease obligation   11,168       11,790  
Deferred revenue, net of current portion   29,202       38,771  
Total liabilities   106,219       129,487  
Commitments and contingencies – Note 6          
Stockholders’ equity:          
Common shares, €0.09 par value; 67,500,000 shares authorized at June 30, 2023 and December 31, 2022; 49,853,659 and 46,310,589 shares issued and outstanding as at June 30, 2023 and December 31, 2022, respectively   5,099       4,751  
Additional paid-in capital   948,913       870,874  
Accumulated other comprehensive income   (26,711 )     (30,448 )
Accumulated deficit   (669,896 )     (598,122 )
Total stockholders’ equity   257,405       247,055  
Total liabilities and stockholders’ equity $ 363,624     $ 376,542  

MERUS N.V.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(Amounts in thousands, except per share data)
           
  Three Months Ended

June 30, 		    Six Months Ended

June 30, 		 
  2023     2022     2023     2022  
Collaboration revenue $ 10,476     $ 12,684     $ 23,975     $ 24,339  
Total revenue   10,476       12,684       23,975       24,339  
Operating expenses:                      
Research and development   28,298       31,096       63,163       58,071  
General and administrative   16,063       12,695       31,449       24,448  
Total operating expenses   44,361       43,791       94,612       82,519  
Operating loss   (33,885 )     (31,107 )     (70,637 )     (58,180 )
Other income, net:                      
Interest income, net   2,795       316       4,790       422  
Foreign exchange gains (loss)   551       24,607       (4,890 )     32,337  
Other gains, net   —       601       —       1,059  
Total other income (loss), net   3,346       25,524       (100 )     33,818  
                       
Net loss before income taxes   (30,539 )     (5,583 )     (70,737 )     (24,362 )
Income tax expense   1,494       131       1,037       245  
Net loss $ (32,033 )   $ (5,714 )   $ (71,774 )   $ (24,607 )
Other comprehensive loss:                      
Currency translation adjustment   (505 )     (19,921 )     3,737       (25,969 )
Comprehensive loss $ (32,538 )   $ (25,635 )   $ (68,037 )   $ (50,576 )
Net loss per share attributable to common stockholders:                              
Basic and diluted $ (0.66 )   $ (0.13 )   $ (1.52 )   $ (0.56 )
Weighted-average common shares outstanding:                              
Basic and diluted   48,321,708       43,636,337       47,328,259       43,781,195  

About Merus N.V.


Merus
 is a clinical-stage oncology company developing innovative full-length human bispecific and trispecific antibody therapeutics, referred to as Multiclonics®. Multiclonics® are manufactured using industry standard processes and have been observed in preclinical and clinical studies to have several of the same features of conventional human monoclonal antibodies, such as long half-life and low immunogenicity. For additional information, please visit Merus’ website, Twitter and LinkedIn.

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 the content and timing of clinical trials, data readouts and clinical, regulatory, strategy and development updates for our product candidates; Merus’ belief that receipt of FTD for petosemtamab validates its potential to address the unmet need of patients with previously treated recurrent or metastatic HNSCC; Merus’ belief that the robust clinical data observed in previously treated HNSCC support a phase 3 trial of petosemtamab monotherapy in patients with previously treated head and neck cancer, which could potentially start in mid-2024; the progress to date with the combination of petosemtamab and Keytruda® as potential front-line therapy in advanced head and neck cancer; Merus’ anticipation of potentially initiating a randomized phase 3 trial of petosemtamab monotherapy, or investigators’ choice of single agent chemotherapy or cetuximab in 2L/3L HNSCC; the potential design and details of such a phase 3 trial; the enrollment of approximately 40 patients in previously treated HNSCC with petosemtamab monotherapy at the 1100 or 1500 mg dose levels to confirm a suitable dose for future randomized trials; Merus’ consideration of conducting a phase 3 trial in front-line therapy in advanced head and neck cancer; the planned interim clinical data update in the first half of 2024 concerning the combination of petosemtamab with Keytruda® in front-line HNSCC; the potential benefits of FTD for petosemtamab and BTD designations for Zeno and the ability of Merus to maintain such designations; Merus’ belief that a obtaining a commercialization partnership agreement will be an essential step in bringing Zeno to patients with NRG1+ cancer, if approved; the planned presentations of Zeno at ESMO 2023; any planned updates on Zeno and NRG1+ cancer, and Zeno in combination with an ADT for the potential treatment of CRPC; statements regarding the sufficiency of our cash, cash equivalents and marketable securities, and expectation that it will fund the Company into 2026; the advancement of the phase 1 trial of MCLA-145, as monotherapy and in combination with Keytruda®; the advancement of the phase 1/2 trial for MCLA-129 in the dose expansion phase, in monotherapy in Met ex14 NSCLC, EGFR ex20 NSCLC, and in HNSCC, as well as in combination with Tagrisso® in treatment naïve EGFRm NSCLC and in patients with EGFRm NSCLC that have progressed on Tagrisso®; the design and treatment potential of our bispecific antibody candidates and impact of their preclinical data; the benefits of the collaboration between Loxo Oncology at Lilly and Merus, its potential for future value generation, including whether and when Merus will receive any future payment under the collaboration, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; Merus’ and Lilly’s activities under the agreement; our global collaboration and license agreement with Incyte, its progress and potential development and commercialization of up to ten bispecific and monospecific antibodies from our Biclonics® platform and Incyte’s clinical study of INCA33890 developed in collaboration with us, including whether and when Merus will receive any future payment under the collaboration, including milestones or royalties, and the amounts of such payments; whether any programs under the collaboration will be successful; and our collaboration and license agreement with Betta, which permits Betta to develop MCLA-129 and potentially commercialize exclusively in China, while Merus retains full ex-China rights, including any future clinical development by Betta of MCLA-129 alone or in combination with befotertinib, a third generation EGFR tyrosine kinase inhibitor. 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 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, including, but not limited to, the following: our need for additional funding, which may not be available and which may require us to restrict our operations or require us to relinquish rights to our technologies or antibody candidates; potential delays in regulatory approval, which would impact our ability to commercialize our product candidates and affect our ability to generate revenue; the lengthy and expensive process of clinical drug development, which has an uncertain outcome; the unpredictable nature of our early stage development efforts for marketable drugs; potential delays in enrollment of patients, which could affect the receipt of necessary regulatory approvals; our reliance on third parties to conduct our clinical trials and the potential for those third parties to not perform satisfactorily; impacts of the COVID-19 pandemic; we may not identify suitable Biclonics® or bispecific antibody candidates under our collaborations or our collaborators may fail to perform adequately under our collaborations; our reliance on third parties to manufacture our product candidates, which may delay, prevent or impair our development and commercialization efforts; protection of our proprietary technology; our patents may be found invalid, unenforceable, circumvented by competitors and our patent applications may be found not to comply with the rules and regulations of patentability; we may fail to prevail in potential lawsuits for infringement of third-party intellectual property; our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks; and risks related to our ceasing to qualify as an emerging growth company and a smaller reporting company after December 31, 2021.

These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-Q for the period ended June 30, 2023, filed with the Securities and Exchange Commission, or SEC, on August 7, 2023, and our other reports filed with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except as required under applicable law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Multiclonics®, Biclonics® and Triclonics® are registered trademarks of Merus N.V.



Investor and Media Inquiries: 
Sherri Spear
Merus N.V.
VP Investor Relations and Corporate Communications
617-821-3246
[email protected] 

Kathleen Farren 
Merus N.V.
Investor Relations and Corporate Communications 
617-230-4165
[email protected]

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Medalist Diversified REIT, Inc. Shifts to Long-Term Value Creation Amid Current Market Conditions

Medalist Diversified REIT, Inc. Shifts to Long-Term Value Creation Amid Current Market Conditions

RICHMOND, Va.–(BUSINESS WIRE)–
Medalist Diversified REIT, Inc. (NASDAQ: MDRR) (the “Company” or “Medalist”), a Virginia-based real estate investment trust that specializes in acquiring, owning and managing commercial real estate in the Southeast region of the U.S., announced today that it has paused its previously announced plan to sell certain assets and has shifted its strategy to focus on continuing to optimize long-term asset value. The move responds to evolving market conditions and aligns with the Company’s commitment to its stockholders.

Francis P. Kavanaugh, the Company’s interim Chief Executive Officer and President, articulated this transition: “In response to the weakening capital markets, we are adjusting our approach to better serve the interests of our stockholders. We believe that selling assets in the current environment would not yield the best results for our stockholders. Instead, we are pivoting to focus on optimizing our existing portfolio, which we believe will be a more effective path to enhancing stockholder value.”

Medalist will devote its resources to the continuous improvement of its properties and strengthening the credit profiles of its tenants. Kavanaugh continued, “We believe that our properties provide a solid foundation for growth. Our plan moving forward is to focus on optimization of our properties through strategic leasing and value-add enhancements over the next several months. By enhancing our properties and improving the experiences of our tenants, we aim to create lasting value.”

Medalist’s Board of Directors and management team express their deep gratitude to the Company’s stockholders for their ongoing patience and support during this period of transition and remain steadfast in their commitment to acting in the best interests of stockholders and driving long-term value.

About Medalist Diversified REIT

Medalist Diversified REIT Inc. is a Virginia-based real estate investment trust that specializes in acquiring, owning and managing value-add commercial real estate in the Mid-Atlantic and Southeast regions. The Company’s strategy is to focus on value-add and opportunistic commercial real estate which is expected to provide an attractive balance of risk and returns. Medalist utilizes a rigorous, consistent and replicable process for sourcing and conducting due diligence of acquisitions. The Company seeks to maximize operating performance of current properties by utilizing a hands-on approach to property management while monitoring the middle market real estate markets in the southeast for acquisition opportunities and disposal of properties as considered appropriate. For more information on Medalist, please visit the Company website at www.medalistreit.com.

Forward-Looking Statements

This press release contains statements that are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements are not historical and are typically identified by such words as “believe,” “expect,” “anticipate,” “intend,” “estimate, “may,” “will,” “should” and “could” and include statements about the Company’s strategy and the impact, if any, of such strategy on the Company and the trading price of the Company’s common stock. Forward-looking statements are based upon the Company’s present expectations but are not guarantees or assurances as to future developments or results. Factors that may cause actual developments or results to differ from those reflected in forward-looking statements include, without limitation, adverse changes in the pricing of the Company’s assets, disruptions associated with management internalizations, increased costs of, and reduced availability of, capital and those included in the Company’s most recent Annual Report on Form 10-K and in the Company’s other filings with the Securities and Exchange Commission. Investors should not place undue reliance upon forward-looking statements. The Company disclaims any obligation to publicly update or revise any forward-looking statements to reflect changes and new developments except as required by law or regulation.

Brent Winn

Medalist Diversified REIT, Inc.

[email protected]

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: REIT Other Construction & Property Residential Building & Real Estate Commercial Building & Real Estate Construction & Property

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Ameriprise Financial Inspires, Motivates and Empowers Women at Its Annual Women Advisor Summits

Ameriprise Financial Inspires, Motivates and Empowers Women at Its Annual Women Advisor Summits

MINNEAPOLIS–(BUSINESS WIRE)–
More than 800 advisors, staff members and corporate leaders from Ameriprise Financial (NYSE: AMP) recently gathered in Minneapolis for the firm’s annual Women Advisor Summits. Two separate three-day events featured compelling keynote speakers, insights from top women advisors and Ameriprise executives, and breakout sessions focused on practice growth and delivering exceptional client experiences.

Bill Williams, president and executive vice president of the Ameriprise Independent Advisors channel and Pat O’Connell, president and executive vice president of the Ameriprise Branch and Institutions Advisors channels co-hosted the events along with the company’s Women’s Empowerment (WE) Networks.

“We’re fiercely committed to making Ameriprise the firm of choice for women in the financial services industry,” said Williams, “Our talented women advisors and staff members make a tremendous impact on the lives of their clients, and we’re honored to support their success.”

“Empowerment thrives at our Women’s Summit where success stories intertwine, inspiring women to reach new heights, overcome challenges and embrace their potential as catalysts for growth,” said Leasha Flammio-Watson, Private Wealth Advisor and President of the Ameriprise Women’s Empowerment Network for its Independent Channel. “It is powerful having a room full of women who are extremely accomplished share how they achieved success and shattered barriers. I’m proud to affiliate my practice with a company that’s committed to creating new opportunities for current and future generations of women.”

“Our Women’s Advisor Summits offer an incredible opportunity to help advisors at all stages of their careers grow and succeed,” said O’Connell, President and Executive Vice President of the Ameriprise Branch and Institutions Advisor. “We believe in fostering a culture of continuous growth and development, so advisors and their staff members can stay ahead of the ever-changing financial landscape and bring the insights and strategies to their clients.”

“This conference brings together the firm’s top women advisors who are connecting on topics that can drive growth in their practices and make a meaningful difference in the lives of clients,” said Katie Whalen, Financial Advisor and President of the Ameriprise Women’s Empowerment Network for its branch channel. “The energy and focus are palpable – between the coaching, peer learning, connection and support, advisors are heading back to their offices motivated and ready to implement new strategies to drive client satisfaction and practice growth.”

Ameriprise hosts events and professional development sessions each year as part of the firm’s broader diversity and inclusion strategy to recruit, retain, develop and engage a diverse workforce. To learn more about initiatives at Ameriprise to support women advisors, visit: https://www.ameriprise.com/careers/experienced-financial-advisors/opportunity-value/women-advisors.

About Ameriprise Financial

At Ameriprise Financial, we have been helping people feel confident about their financial future for more than 125 years. With extensive investment advice, asset management and insurance capabilities and a nationwide network of approximately 10,000 financial advisors, we have the strength and expertise to serve the full range of individual and institutional investors’ financial needs.

Investment products are not insured by the FDIC, NCUA or any federal agency, are not deposits or obligations of, or guaranteed by any financial institution, and involve investment risks including possible loss of principal and fluctuation in value.

Ameriprise Financial is an equal opportunity employer. We consider all qualified applicants without regard to race, color, religion, sex, national origin, genetic information, age, sexual orientation, citizenship, gender identity, disability, veteran status, marital status, family status or any other basis prohibited by law. You may request assistance if you require a reasonable accommodation for any part of the hiring process.

Ameriprise Financial Services, LLC. Member FINRA and SIPC.

© 2023 Ameriprise Financial, Inc. All rights reserved.

Alison Mueller, Vice President

[email protected]

(612) 678-7183

KEYWORDS: United States North America Minnesota

INDUSTRY KEYWORDS: Personal Finance Insurance Women Finance Banking Professional Services Business Consumer Asset Management Other Professional Services

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Artesian Resources Corporation Declares Common Stock Dividend

NEWARK, Del., Aug. 07, 2023 (GLOBE NEWSWIRE) — Artesian Resources Corporation (Nasdaq: ARTNA) announced today that its Board of Directors has declared a regular quarterly dividend on the company’s Class A and Class B Common Stock. The quarterly dividend of $0.284 per share is payable August 25, 2023 to shareholders of record at the close of business on August 17, 2023.

This marks Artesian’s 123rd consecutive quarterly dividend paid to shareholders.

About Artesian Resources

Artesian Resources Corporation operates as a holding company of wholly-owned subsidiaries offering water and wastewater services, and related services, on the Delmarva Peninsula. Artesian Water Company, the principal subsidiary, is the oldest and largest regulated water utility on the Delmarva Peninsula and has been providing water service since 1905. Artesian supplies 8.7 billion gallons of water per year through 1,442 miles of water main to nearly a third of Delaware residents.

Contact:

Nicholle Taylor
Investor Relations
(302) 453-6900
[email protected]



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Hercules Capital, Inc. Announces Public Offering of Common Stock

Hercules Capital, Inc. Announces Public Offering of Common Stock

PALO ALTO, Calif.–(BUSINESS WIRE)–
Hercules Capital, Inc. (NYSE: HTGC) (“Hercules”) today announced that it plans to make a public offering of 6,000,000 shares of its common stock. Hercules also expects to grant the underwriters for the offering an option to purchase up to an additional 900,000 shares of its common stock.

Morgan Stanley, UBS Investment Bank and Wells Fargo Securities are acting as joint lead book-running managers, Goldman Sachs & Co. LLC, Jefferies and Keefe, Bruyette & Woods, A Stifel Company, are acting as joint book-running managers, and Compass Point, JMP Securities, a Citizens Company and MUFG are acting as co-managers in this offering.

Hercules expects to use the net proceeds from this offering (i) to fund investments in debt and equity securities in accordance with its investment objectives, (ii) to repay indebtedness under its revolving credit facility and (iii) for other general corporate purposes.

The securities described above are being offered by Hercules pursuant to an effective shelf registration statement previously filed with and deemed immediately effective upon filing by the Securities and Exchange Commission (the “SEC”) on December 17, 2021. The offering may be made only by means of a prospectus supplement and the accompanying prospectus, copies of the preliminary prospectus supplement and accompanying prospectus, and, when available, the prospectus supplement, may be obtained from (1) Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department; UBS Securities LLC, 1285 Avenue of the Americas, New York, New York, 10019, Attn: Prospectus Department, by email: [email protected]; or Wells Fargo Securities, LLC, 500 West 33rd Street, New York, New York, 10001, Attn: Equity Syndicate Department, by calling toll free 1-800-326-5897, or by e-mail at [email protected].

Investors are advised to carefully consider the investment objectives, risks, and charges and expenses of Hercules before investing. The preliminary prospectus supplement and the accompanying prospectus, which have been filed with the SEC, contain this and other information about Hercules and should be read carefully before investing.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the shares in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Hercules Capital, Inc.

Hercules Capital, Inc. (NYSE: HTGC) is the leading and largest specialty finance company focused on providing senior secured venture growth loans to high-growth, innovative venture capital-backed companies in a broad variety of technology, life sciences and sustainable and renewable technology industries. Since inception (December 2003), Hercules has committed more than $17 billion to over 600 companies and is the lender of choice for entrepreneurs and venture capital firms seeking growth capital financing.

Hercules, through its wholly owned subsidiary, Hercules Adviser LLC (“Hercules Adviser”), also maintains an asset management business through which it manages investments for external parties (“Adviser Funds”). Hercules Adviser is registered as an investment adviser under the Investment Advisers Act of 1940.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We may use words such as “anticipates,” “believes,” “expects,” “intends,” “will,” “should,” “may” and similar expressions to identify forward-looking statements. Forward-looking statements are not guarantees of future performance and should not be relied upon in making any investment decision. Such statements are based on currently available operating, financial and competitive information and are subject to various risks and uncertainties that could cause actual results to differ materially from our historical experience and our present expectations. While we cannot identify all such risks and uncertainties, we urge you to read the risks discussed in our Annual Report on Form 10-K and other materials that we publicly file with the Securities and Exchange Commission. Any forward-looking statements made in this press release are made only as of the date hereof. Hercules assumes no obligation to update any such statements in the future.

Michael Hara

Investor Relations and Corporate Communications

Hercules Capital, Inc.

(650) 433-5578

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Professional Services Finance

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CVD Equipment Corporation to Announce Second Quarter 2023 Financial Results on August 14, 2023

CVD Equipment Corporation to Announce Second Quarter 2023 Financial Results on August 14, 2023

CENTRAL ISLIP, N.Y.–(BUSINESS WIRE)–
CVD Equipment Corporation (NASDAQ: CVV), a leading provider of chemical vapor deposition and thermal process equipment, announced today that it will release its second quarter 2023 financial results after the markets close on Monday, August 14, 2023.

The Company will hold a conference call to discuss its results at 5:00 p.m. (Eastern Time) that day. To participate in the live conference call, please dial toll free (877) 407-2991 or international (201) 389-0925. A telephone replay will be available for 7 days. To access the replay, dial (877) 660-6853 or international (201) 612-7415. The replay passcode is 13740382.

A live and archived webcast of the call will also be available on the company’s website at www.cvdequipment.com/events. The archived webcast will be available at the same location approximately two hours following the end of the live event.

About CVD Equipment Corporation

CVD Equipment Corporation (NASDAQ: CVV) designs, develops, and manufactures a broad range of chemical vapor deposition, thermal processing, physical vapor transport, gas and chemical delivery control systems, and other equipment and process solutions used to develop and manufacture materials and coatings for industrial applications and research. Our products are used in production environments as well as research and development centers, both academic and corporate. Major target markets include high power electronics (silicon carbide), EV battery materials / energy storage (carbon nanotubes, graphene, and silicon nanowires) and aerospace & defense (ceramic matrix composites). Through its application laboratory, the Company allows customers the option to bring their process tools to our laboratory and to work collaboratively with our scientists and engineers to optimize process performance.

Certain information in this press release contains statements that are forward-looking in nature and involve certain significant risks and uncertainties. Actual results could differ materially from such forward-looking information. The Company’s Securities and Exchange Commission filings identify many such risks and uncertainties. Any forward-looking information in this press release is qualified in its entirety by the risks and uncertainties described in such Securities and Exchange Commission filings.

For further information about this topic please contact:

Richard Catalano, Vice President & CFO

Phone: (631) 981-7081

Email: [email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Machine Tools, Metalworking & Metallurgy Engineering Chemicals/Plastics Automotive Manufacturing Aerospace Manufacturing Other Manufacturing

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Great Elm Capital Corp. Announces Public Offering of Unsecured Notes

WALTHAM, Mass., Aug. 07, 2023 (GLOBE NEWSWIRE) — Great Elm Capital Corp. (the “Company” or “GECC”) (NASDAQ: GECC) announced today the commencement of an underwritten public offering of unsecured notes due 2028 (the “Notes”). The Notes are expected to be listed on The Nasdaq Global Market under the trading symbol “GECCZ,” and to trade thereon within 30 days from the original issue date. The interest rate and other terms of the Notes will be determined by negotiations between the Company and the underwriters.

The Company expects to use the net proceeds from the offering, along with cash on hand, to redeem all of its outstanding 6.50% notes due 2024 and to pay related fees and expenses and for general corporate purposes. The Company may also elect to (i) redeem a portion of its outstanding 6.75% notes due 2025, (ii) redeem a portion of its outstanding 5.875% notes due 2026 or (iii) repay all or a portion of its borrowings outstanding under the Loan, Guarantee and Security Agreement, as amended, with City National Bank with proceeds from this offering.

Ladenburg Thalmann & Co. Inc., Janney Montgomery Scott LLC and Oppenheimer & Co. Inc. are acting as joint book-running managers for the offering.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities in this offering or any other securities nor will there be any sale of these securities or any other securities referred to in this press release in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission (the “SEC”) but has not yet been declared effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. The offering will be made only by means of a prospectus, copies of which may be obtained, when available, from:

Ladenburg Thalmann & Co. Inc.

640 5th Avenue, 4

th

Floor

New York, New York 10019

[email protected]

Investors are advised to carefully consider the investment objectives, risks and charges and expenses of the Company before investing. The preliminary prospectus, dated August 7, 2023, which has been filed with the SEC, contains a description of these matters and other important information about the Company and should be read carefully before investing.

The information in this press release and the preliminary prospectus is not complete and may be changed.

About Great Elm Capital Corp.

GECC is an externally managed business development company that seeks to generate current income and capital appreciation by investing in debt and income generating equity securities, including investments in specialty finance businesses.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this communication that are not historical facts are “forward-looking” statements within the meaning of the federal securities laws. These statements are often, but not always, made through the use of words or phrases such as “expect,” “anticipate,” “should,” “will,” “estimate,” “designed,” “seek,” “continue,” “upside,” “potential” and similar expressions. All such forward-looking statements involve estimates and assumptions that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from the results expressed in the statements. Among the key factors that could cause actual results to differ materially from those projected in the forward-looking statements are: conditions in the credit markets, rising interest rates, inflationary pressure, the price of GECC common stock and the performance of GECC’s portfolio and investment manager. Information concerning these and other factors can be found in GECC’s registration statement, its Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission. GECC assumes no obligation to, and expressly disclaims any duty to, update any forward-looking statements contained in this communication or to conform prior statements to actual results or revised expectations except as required by law. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof.

Media & Investor Contact:

Investor Relations
[email protected]



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MRC Global Announces Second Quarter 2023 Results

HOUSTON, Aug. 07, 2023 (GLOBE NEWSWIRE) — MRC Global Inc. (NYSE: MRC), the leading global distributor of pipe, valves, fittings and infrastructure products and services to diversified energy, industrial and gas utilities end-markets, today announced second quarter 2023 results.

Net income attributable to common stockholders for the second quarter of 2023 was $18 million, or $0.21 per diluted share, as compared to the second quarter of 2022 net income of $8 million, or $0.09 per diluted share. Adjusted net income attributable to common stockholders for the second quarter of 2023 was $22 million, or $0.25 per diluted share, as compared to the second quarter of 2022 adjusted net income of $23 million, or $0.27 per diluted share.

MRC Global’s second quarter 2023 gross profit was $175 million, or 20.1% of sales, as compared to the second quarter 2022 gross profit of $151 million, or 17.8% of sales. Gross profit for the second quarter of 2023 and 2022 includes $2 million and $20 million of expense, respectively, in cost of sales relating to the use of the last-in, first-out (LIFO) method of inventory cost accounting. Adjusted Gross Profit, which excludes (among other items) the impact of LIFO, was $187 million, or 21.5% of sales, for the second quarter of 2023 and was $181 million, or 21.3% of sales, for the second quarter of 2022. 


Second Quarter 2023 Financial Highlights:

  • Sales of $871 million, a 3% improvement compared to the same quarter a year ago
  • Adjusted Gross Profit, as a percentage of sales, of 21.5%, an increase of 30 basis points compared to the first quarter of 2023
  • Adjusted EBITDA of $63 million, or 7.2% of sales and our 5th consecutive quarter above 7%
  • Cash Flow from operations of $20 million during the quarter

Rob Saltiel, MRC Global’s President and CEO stated, “Our second quarter results delivered revenue growth over last year, better-than-expected cash flow generation and strong adjusted gross profit margins. We expanded our revenue backlog in the quarter, aided by gains in our International segment and our DIET sector.

“We are anticipating lower annual growth in 2023 for our U.S. segment than previously forecast due primarily to a slower ramp-up in our Gas Utilities sector sales during the current construction season. Although the long-term growth fundamentals of this sector remain intact, several key Gas Utilities customers are currently focused on reducing their product inventory levels over the next few quarters due to more certainty in the supply chain and associated lead times. As a result, we expect full-year revenues to increase in the upper single-digit percentage range, compared to 2022 levels, an adjustment to our prior guidance,” Mr. Saltiel added.

Adjusted EBITDA was $63 million in the second quarter of 2023 compared to $65 million for the same period in 2022.

Adjusted net income attributable to common stockholders, Adjusted EBITDA, Adjusted EBITDA margin, Adjusted Gross Profit, Adjusted SG&A, Net Debt and Leverage Ratio are all non-GAAP measures. Please refer to the reconciliation of each of these measures to the nearest GAAP measure in this release. 

Selling, general and administrative (SG&A) expenses were $130 million, or 14.9% of sales, for the second quarter of 2023 compared to $120 million, or 14.2% of sales, for the same period in 2022. The primary driver of the increase relates to higher employee-related costs including hiring additional resources to support the growth in our business as well as an increase in benefit costs. Other costs include non-recurring IT related professional fees.

An income tax expense of $10 million was incurred in the second quarter of 2023, with an effective tax rate of 29%, as compared to an income tax expense of $6 million for the second quarter of 2022. Our rates differ from the U.S. federal statutory rate of 21% as a result of state income taxes, non-deductible expenses, and differing foreign income tax rates. In addition, the effective tax rate for the three months ended June 30, 2023, was higher than the U.S. federal statutory rate due to foreign losses with no tax benefit.

Sales

The company’s sales were $871 million for the second quarter of 2023, which was 2% lower than the first quarter of 2023 and 3% higher than the second quarter of 2022. As compared to the second quarter of 2022, the Production and Transmission Infrastructure (PTI) sector led with 10% growth followed by the Gas Utilities sector at 3%, partially offset by the Downstream, Industrial and Energy Transition (DIET) sector, which declined 5%. Sequentially, the DIET sector declined offsetting increases in the Gas Utilities and PTI sectors.

Sales by Segment

U.S. sales in the second quarter of 2023 were $727 million, up $10 million, or 1%, from the same quarter in 2022. PTI sector sales increased by $19 million, or 9%, resulting from increased customer facility infrastructure activity in the Permian and Rockies as well as pipeline activity in the Haynesville and Northeast. The Gas Utilities sector revenue increased $10 million, or 3%, driven by increased capex spending for modernization and replacement activity. DIET sector sales decreased $19 million, or 10% due to the culmination of biofuel refinery projects.

Sequentially, as compared to the first quarter of 2023, U.S. sales decreased $13 million, or 2%, driven by the DIET sector, which decreased $31 million, or 15%, due to the timing of on-going projects and turnarounds as well as non-recurring projects. The U.S. Gas Utilities sector increased 5% primarily due to a seasonal increase as the heavier construction period began for replacement and modernization activity. PTI increased $3 million or 1% primarily due to increased activity for midstream related infrastructure.

Canada sales in the second quarter of 2023 were $38 million, down $2 million, or 5%, from the same quarter in 2022, as declines in the DIET and Gas Utilities sectors offset an increase in the PTI sector. Canada sales also include a $2 million unfavorable impact from weaker foreign currencies.

Sequentially, as compared to the prior quarter, Canada sales declined $4 million, or 10%, due to non-recurring project orders in the PTI sector.

International sales in the second quarter of 2023 were $106 million, up $15 million, or 16%, from the same period in 2022 including a $3 million unfavorable impact from weaker foreign currencies. The increase was driven by the PTI sector primarily in Australia and the U.K. followed by the DIET sector in the Netherlands, Singapore and the U.K. 

Sequentially, as compared to the previous quarter, International sales were up $3 million, or 3%, due to increased sales in the PTI sector primarily in Australia and the U.K.

Sales by Sector

Gas Utilities sector sales, which are primarily U.S. based, were $323 million in the second quarter of 2023, or 37% of total sales, an increase of $9 million, or 3%, from the second quarter of 2022.

Sequentially, as compared to the first quarter of 2023, the Gas Utilities sector increased $16 million, or 5%, driven by the U.S. segment.

DIET sector sales in the second quarter of 2023 were $245 million, or 28% of total sales, a decrease of $14 million, or 5%, from the second quarter of 2022. The decrease in DIET sector sales was primarily due to the U.S. segment partially offset by an increase in the International segment.

Sequentially, as compared to the previous quarter, sales in the DIET sector were down $33 million, or 12%, primarily due to the timing of projects in the U.S. segment.

PTI sector sales in the second quarter of 2023 were $303 million, or 35% of total sales, an improvement of $28 million, or 10%, from the second quarter of 2022. The increase in PTI sales was led by the U.S. segment, followed by the International and Canada segments.

Sequentially, as compared to the prior quarter, PTI sector sales increased $3 million, or 1%, led by the International segment followed by the U.S. segment and partially offset by a decline in the Canada segment.

Backlog

As of June 30, 2023, the company’s backlog was $764 million, up 1% sequentially from March 31, 2023, and 2% since June 30, 2022. 

Balance Sheet and Cash Flow

Cash provided by operations was $20 million in the second quarter of 2023. As of June 30, 2023, the cash balance was $31 million, long-term debt (including current portion) was $371 million, and Net Debt was $340 million. Availability under the company’s asset-based lending facility was $599 million, and available liquidity was $630 million as of June 30, 2023. 

Please refer to the reconciliation of non-GAAP measures (Net Debt) to GAAP measures (Long-term Debt) in this release.

Conference Call

The company will hold a conference call to discuss its second quarter 2023 results at 10:00 a.m. Eastern Time (9:00 a.m. Central Time) on August 8, 2023. To participate in the call, please dial 201-689-8261 and ask for the MRC Global conference call at least 10 minutes prior to the start time. To access the conference call, live over the Internet, please log onto the web at www.mrcglobal.com and go to the “Investors” page of the company’s website at least fifteen minutes early to register, download and install any necessary audio software. For those who cannot listen to the live call, a replay will be available through August 22, 2023, and can be accessed by dialing 201-612-7415 and using pass code 13739473#. Also, an archive of the webcast will be available shortly after the call at www.mrcglobal.com for 90 days.

About MRC Global Inc.

Headquartered in Houston, Texas, MRC Global (NYSE: MRC) is the leading global distributor of pipe, valves, fittings (PVF) and other infrastructure products and services to diversified end-markets including the gas utilities, downstream, industrial and energy transition, and production and transmission sectors. With over 100 years of experience, MRC Global has provided customers with innovative supply chain solutions, technical product expertise and a robust digital platform from a worldwide network of 216 locations including valve and engineering centers. The company’s unmatched quality assurance program offers over 250,000 SKUs from over 9,000 suppliers, simplifying the supply chain for approximately 10,000 customers. Find out more at www.mrcglobal.com

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Words such as “will,” “expect,” “expected,” “anticipating,” “intend,” “believes,” “on-track,” “well positioned,” “strong position,” “looking forward,” “guidance,” “plans,” “can,” “target,” “targeted” and similar expressions are intended to identify forward-looking statements.

Statements about the company’s business, including its strategy, its industry, the company’s future profitability, the company’s guidance on its sales, adjusted EBITDA, adjusted EBITDA margin, tax rate, capital expenditures, achieving cost savings and cash flow, debt reduction, liquidity, growth in the company’s various markets and the company’s expectations, beliefs, plans, strategies, objectives, prospects and assumptions are not guarantees of future performance. These statements are based on management’s expectations that involve a number of business risks and uncertainties, any of which could cause actual results to differ materially from those expressed in or implied by the forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, most of which are difficult to predict and many of which are beyond MRC Global’s control, including the factors described in the company’s SEC filings that may cause the company’s actual results and performance to be materially different from any future results or performance expressed or implied by these forward-looking statements.

These risks and uncertainties include (among others) decreases in capital and other expenditure levels in the industries that the company serves; U.S. and international general economic conditions; geopolitical events; decreases in oil and natural gas prices; unexpected supply shortages; loss of third-party transportation providers; cost increases by the company’s suppliers and transportation providers; increases in steel prices, which the company may be unable to pass along to its customers which could significantly lower the company’s profit; the company’s lack of long-term contracts with most of its suppliers; suppliers’ price reductions of products that the company sells, which could cause the value of its inventory to decline; decreases in steel prices, which could significantly lower the company’s profit; a decline in demand for certain of the products the company distributes if tariffs and duties on these products are imposed or lifted; holding more inventory than can be sold in a commercial time frame; significant substitution of renewables and low-carbon fuels for oil and gas, impacting demand for the company’s products; risks related to adverse weather events or natural disasters; environmental, health and safety laws and regulations and the interpretation or implementation thereof; changes in the company’s customer and product mix; the risk that manufacturers of the products that the company distributes will sell a substantial amount of goods directly to end users in the industry sectors that the company serves; failure to operate the company’s business in an efficient or optimized manner; the company’s ability to compete successfully with other companies; the company’s lack of long-term contracts with many of its customers and the company’s lack of contracts with customers that require minimum purchase volumes; inability to attract and retain employees or the potential loss of key personnel; adverse health events, such as a pandemic; interruption in the proper functioning of the company’s information systems; the occurrence of cybersecurity incidents; risks related to the company’s customers’ creditworthiness; the success of acquisition strategies; the potential adverse effects associated with integrating acquisitions and whether these acquisitions will yield their intended benefits; impairment of the company’s goodwill or other intangible assets; adverse changes in political or economic conditions in the countries in which the company operates; the company’s significant indebtedness; the dependence on the company’s subsidiaries for cash to meet parent company obligations; changes in the company’s credit profile; potential inability to obtain necessary capital; the sufficiency of the company’s insurance policies to cover losses, including liabilities arising from litigation; product liability claims against the company; pending or future asbestos-related claims against the company; exposure to U.S. and international laws and regulations, regulating corruption, limiting imports or exports or imposing economic sanctions; risks relating to ongoing evaluations of internal controls required by Section 404 of the Sarbanes-Oxley Act; and risks related to changing laws and regulations including trade policies and tariffs.

For a discussion of key risk factors, please see the risk factors disclosed in the company’s SEC filings, which are available on the SEC’s website at

www.sec.gov

and on the company’s website,

www.mrcglobal.com

. MRC Global’s filings and other important information are also available on the Investors page of the company’s website at

www.mrcglobal.com.

Undue reliance should not be placed on the company’s forward-looking statements. Although forward-looking statements reflect the company’s good faith beliefs, reliance should not be placed on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, which may cause the company’s actual results, performance or achievements or future events to differ materially from anticipated future results, performance or achievements or future events expressed or implied by such forward-looking statements. The company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, except to the extent required by law.

Contact:

Monica Broughton
VP, Investor Relations & Treasury
MRC Global Inc.
[email protected]  
832-308-2847

MRC Global Inc.
Condensed Consolidated Balance Sheets (Unaudited)

(in millions, except shares)
    June 30,     December 31,  
    2023     2022  
                 
Assets                
Current assets:                
Cash   $ 31     $ 32  
Accounts receivable, net     519       501  
Inventories, net     674       578  
Other current assets     39       31  
Total current assets     1,263       1,142  
                 
Long-term assets:                
Operating lease assets     206       202  
Property, plant and equipment, net     78       82  
Other assets     16       22  
                 
Intangible assets:                
Goodwill, net     264       264  
Other intangible assets, net     173       183  
    $ 2,000     $ 1,895  
                 
Liabilities and stockholders’ equity                
Current liabilities:                
Trade accounts payable   $ 448     $ 410  
Accrued expenses and other current liabilities     97       115  
Operating lease liabilities     37       36  
Current portion of long-term debt     3       3  
Total current liabilities     585       564  
                 
Long-term liabilities:                
Long-term debt, net     368       337  
Operating lease liabilities     186       182  
Deferred income taxes     51       49  
Other liabilities     20       22  
                 
Commitments and contingencies                
                 
6.5% Series A Convertible Perpetual Preferred Stock, $0.01 par value; authorized 363,000 shares; 363,000 shares issued and outstanding     355       355  
                 
Stockholders’ equity:                
Common stock, $0.01 par value per share: 500 million shares authorized, 108,490,740 and 107,864,421 issued, respectively     1       1  
Additional paid-in capital     1,761       1,758  
Retained deficit     (722 )     (768 )
Less: Treasury stock at cost: 24,216,330 shares     (375 )     (375 )
Accumulated other comprehensive loss     (230 )     (230 )
      435       386  
    $ 2,000     $ 1,895  
                 

MRC Global Inc.
Condensed Consolidated Statements of Operations (Unaudited)

(in millions, except per share amounts)
    Three Months Ended     Six Months Ended  
    June 30,     June 30,     June 30,     June 30,  
    2023     2022     2023     2022  
                                 
Sales   $ 871     $ 848     $ 1,756     $ 1,590  
Cost of sales     696       697       1,402       1,303  
Gross profit     175       151       354       287  
Selling, general and administrative expenses     130       120       252       227  
Operating income     45       31       102       60  
Other expense:                                
Interest expense     (10 )     (5 )     (17 )     (11 )
Other, net     (1 )     (6 )     (4 )     (6 )
Income before income taxes     34       20       81       43  
Income tax expense     10       6       23       13  
Net income     24       14       58       30  
Series A preferred stock dividends     6       6       12       12  
Net income attributable to common stockholders   $ 18     $ 8     $ 46     $ 18  
                                 
                                 
Basic earnings per common share   $ 0.21     $ 0.10     $ 0.55     $ 0.22  
Diluted earnings per common share   $ 0.21     $ 0.09     $ 0.54     $ 0.21  
Weighted-average common shares, basic     84.3       83.6       84.1       83.4  
Weighted-average common shares, diluted     85.3       84.9       85.4       84.6  

MRC Global Inc.
Condensed Consolidated Statements of Cash Flows (Unaudited)

(in millions)
    Six Months Ended  
    June 30,     June 30,  
    2023     2022  
                 
Operating activities                
Net income   $ 58     $ 30  
Adjustments to reconcile net income to net cash used in operations:                
Depreciation and amortization     10       9  
Amortization of intangibles     10       11  
Equity-based compensation expense     7       6  
Deferred income tax expense     2       1  
Increase in LIFO reserve     1       26  
Other, net     13       8  
Changes in operating assets and liabilities:                
Accounts receivable     (19 )     (116 )
Inventories     (101 )     (136 )
Other current assets     (9 )     (18 )
Accounts payable     36       116  
Accrued expenses and other current liabilities     (18 )     –  
Net cash used in operations     (10 )     (63 )
                 
Investing activities                
Purchases of property, plant and equipment     (5 )     (5 )
Other investing activities     –       (2 )
Net cash used in investing activities     (5 )     (7 )
                 
Financing activities                
Payments on revolving credit facilities     (497 )     (275 )
Proceeds from revolving credit facilities     530       335  
Payments on long-term obligations     (2 )     (1 )
Dividends paid on preferred stock     (12 )     (12 )
Repurchases of shares to satisfy tax withholdings     (4 )     (2 )
Net cash provided by financing activities     15       45  
                 
Increase (decrease) in cash     –       (25 )
Effect of foreign exchange rate on cash     (1 )     (2 )
Cash — beginning of period     32       48  
Cash — end of period   $ 31     $ 21  
                 

MRC Global Inc.
Supplemental Sales Information (Unaudited)

(in millions)



Disaggregated Sales by Segment and Sector
Three Months Ended
June 30,
  U.S.   Canada   International   Total
2023                      
Gas Utilities $ 321   $ 1   $ 1   $ 323
Downstream, Industrial & Energy Transition   179     4     62     245
Production & Transmission Infrastructure   227     33     43     303
  $ 727   $ 38   $ 106   $ 871
2022                      
Gas Utilities $ 311   $ 3   $ –   $ 314
Downstream, Industrial & Energy Transition   198     7     54     259
Production & Transmission Infrastructure   208     30     37     275
  $ 717   $ 40   $ 91   $ 848
                       

Six Months Ended



June 30,
  U.S.   Canada   International   Total
2023                      
Gas Utilities $ 627   $ 2   $ 1   $ 630
Downstream, Industrial & Energy Transition   389     9     125     523
Production & Transmission Infrastructure   451     69     83     603
  $ 1,467   $ 80   $ 209   $ 1,756
2022                      
Gas Utilities $ 579   $ 6   $ –   $ 585
Downstream, Industrial & Energy Transition   367     14     104     485
Production & Transmission Infrastructure   389     63     68     520
  $ 1,335   $ 83   $ 172   $ 1,590
                       

MRC Global Inc.

Supplemental Sales Information (Unaudited)

(in millions)

Sales by Product Line
    Three Months Ended   Six Months Ended
    June 30,   June 30,   June 30,   June 30,
Type   2023   2022   2023   2022
Line Pipe   $ 128   $ 132   $ 269   $ 244
Carbon Fittings and Flanges     119     116     236     216
Total Carbon Pipe, Fittings and Flanges     247     248     505     460
Valves, Automation, Measurement and Instrumentation     299     280     614     531
Gas Products     214     198     421     382
Stainless Steel and Alloy Pipe and Fittings     36     58     68     94
General Products     75     64     148     123
    $ 871   $ 848   $ 1,756   $ 1,590
                         




MRC Global Inc.
Supplemental Information (Unaudited)
Reconciliation of Gross Profit to Adjusted Gross Profit (a non-GAAP measure)

(in millions)
  Three Months Ended  
  June 30,   Percentage     June 30,   Percentage  
  2023   of Revenue     2022   of Revenue*  
                       
Gross profit, as reported $ 175   20.1 %   $ 151   17.8 %
Depreciation and amortization   5   0.6 %     4   0.5 %
Amortization of intangibles   5   0.6 %     6   0.7 %
Increase in LIFO reserve   2   0.2 %     20   2.4 %
Adjusted Gross Profit $ 187   21.5 %   $ 181   21.3 %
                       

  Six Months Ended  
  June 30,   Percentage     June 30,   Percentage  
  2023   of Revenue*     2022   of Revenue*  
                       
Gross profit, as reported $ 354   20.2 %   $ 287   18.1 %
Depreciation and amortization   10   0.6 %     9   0.6 %
Amortization of intangibles   10   0.6 %     11   0.7 %
Increase in LIFO reserve   1   0.1 %     26   1.6 %
Adjusted Gross Profit $ 375   21.4 %   $ 333   20.9 %
                       


Notes to above:

* Does not foot due to rounding

The company defines Adjusted Gross Profit as sales, less cost of sales, plus depreciation and amortization, plus amortization of intangibles, plus inventory-related charges incremental to normal operations and plus or minus the impact of its LIFO inventory costing methodology. The company presents Adjusted Gross Profit because the company believes it is a useful indicator of the company’s operating performance without regard to items, such as amortization of intangibles, that can vary substantially from company to company depending upon the nature and extent of acquisitions of which they have been involved. Similarly, the impact of the LIFO inventory costing method can cause results to vary substantially from company to company depending upon whether they elect to utilize LIFO and depending upon which method they may elect. The company uses Adjusted Gross Profit as a key performance indicator in managing its business. The company believes that gross profit is the financial measure calculated and presented in accordance with U.S. generally accepted accounting principles that is most directly comparable to Adjusted Gross Profit.

MRC Global Inc.
Supplemental Information (Unaudited)
Reconciliation of Selling, General and Administrative Expenses (SG&A) to Adjusted SG&A (a non-GAAP measure)

(in millions)
  Three Months Ended   Six Months Ended
  June 30,   June 30,   June 30,   June 30,
   2023     2022    2023     2022
               
Selling, general and administrative expenses $ 130     $ 120   $ 252     $ 227
Non-recurring IT related professional fees   (1 )     –     (1 )     –
Adjusted Selling, general and administrative expenses $ 129     $ 120   $ 251     $ 227
                           

MRC Global Inc.
Supplemental Information (Unaudited)
Reconciliation of Net Income to Adjusted EBITDA (a non-GAAP measure)

(in millions)
    Three Months Ended   Six Months Ended  
    June 30,   June 30,   June 30,   June 30,  
    2023   2022   2023   2022  
                           
Net income   $ 24   $ 14   $ 58   $ 30  
Income tax expense     10     6     23     13  
Interest expense     10     5     17     11  
Depreciation and amortization     5     4     10     9  
Amortization of intangibles     5     6     10     11  
Non-recurring IT related professional fees     1     –     1     –  
Increase in LIFO reserve     2     20     1     26  
Equity-based compensation expense (1)     4     3     7     6  
Asset disposal (2)     1     –     1     –  
Foreign currency losses     1     7     4     7  
Adjusted EBITDA   $ 63   $ 65   $ 132   $ 113  




Notes to above:

(1) Charges (pre-tax) recorded in SG&A.
(2) Charge (pre-tax) for an asset disposal in our International segment.

The company defines Adjusted EBITDA as net income plus interest, income taxes, depreciation and amortization, amortization of intangibles, and certain other expenses, including non-cash expenses, (such as equity-based compensation, severance and restructuring, changes in the fair value of derivative instruments, long-lived asset impairments (including goodwill and intangible assets), inventory-related charges incremental to normal operations, and plus or minus the impact of its LIFO inventory costing methodology. The company presents Adjusted EBITDA because the company believes Adjusted EBITDA is a useful indicator of the company’s operating performance. Among other things, Adjusted EBITDA measures the company’s operating performance without regard to certain non-recurring, non-cash or transaction-related expenses. Adjusted EBITDA, however, does not represent and should not be considered as an alternative to net income, cash flow from operations or any other measure of financial performance calculated and presented in accordance with GAAP. Because Adjusted EBITDA does not account for certain expenses, its utility as a measure of the company’s operating performance has material limitations. Because of these limitations, the company does not view Adjusted EBITDA in isolation or as a primary performance measure and also uses other measures, such as net income and sales, to measure operating performance.  See the company’s Annual Report filed on Form 10-K for a more thorough discussion of the use of Adjusted EBITDA.

MRC Global Inc.
Supplemental Information (Unaudited)
Reconciliation of Net Income (Loss) Attributable to Common Stockholders to
Adjusted Net Income (Loss) Attributable to Common Stockholders (a non-GAAP measure)

(in millions, except per share amounts)
  Three Months Ended   Six Months Ended
  June 30, 2023   June 30, 2023
  Amount   Per Share   Amount   Per Share
                       
Net income attributable to common stockholders $ 18   $ 0.21   $ 46   $ 0.54
Non-recurring IT related professional fees, net of tax   1     0.01     1     0.01
Asset disposal, net of tax (1)   1     0.01     1     0.01
Increase in LIFO reserve, net of tax   2     0.02     1     0.01
Adjusted net income attributable to common stockholders $ 22   $ 0.25   $ 49   $ 0.57


Notes to above:

(1) An after-tax charge for an asset disposal in our International segment.

  Three Months Ended   Six Months Ended
  June 30, 2022   June 30, 2022
  Amount   Per Share   Amount   Per Share
                       
Net income attributable to common stockholders $ 8   $ 0.09   $ 18   $ 0.21
Increase in LIFO reserve, net of tax   15     0.18     20     0.24
Adjusted net income attributable to common stockholders $ 23   $ 0.27   $ 38   $ 0.45




Notes to above:

The company defines Adjusted Net Income Attributable to Common Stockholders (a non-GAAP measure) as Net Income Attributable to Common Stockholders less after-tax goodwill and intangible impairment, inventory-related charges, facility closures, severance and restructuring, plus or minus the after-tax impact of its LIFO inventory costing methodology. After-tax impacts were determined using the Company’s U.S. blended statutory rate. The company presents Adjusted Net Income Attributable to Common Stockholders and related per share amounts because the company believes it provides useful comparisons of the company’s operating results to other companies, including those companies with whom we compete in the distribution of pipe, valves and fittings to the energy industry, without regard to the irregular variations from certain restructuring events not indicative of the on-going business. Those items include goodwill and intangible asset impairments, inventory-related charges, facility closures, severance and restructuring as well as the LIFO inventory costing methodology. The impact of the LIFO inventory costing methodology can cause results to vary substantially from company to company depending upon whether they elect to utilize LIFO and depending upon which method they may elect. The company believes that Net Income Attributable to Common Stockholders is the financial measure calculated and presented in accordance with U.S. generally accepted accounting principles that is most directly compared to Adjusted Net Income Attributable to Common Stockholders.

MRC Global Inc.
Supplemental Information (Unaudited)
Reconciliation of Long-term Debt to Net Debt (a non-GAAP measure) and the Leverage Ratio Calculation

(in millions)
  June 30,
  2023
     
Long-term debt, net $ 368
Plus: current portion of long-term debt   3
Long-term debt   371
Less: cash   31
Net Debt $ 340
     
Net Debt $ 340
Trailing twelve months adjusted EBITDA   280
Leverage ratio   1.2




Notes to above:

Net Debt and related leverage metrics may be considered non-GAAP measures. The company defines Net Debt as total long-term debt, including current portion, minus cash. The company defines its leverage ratio as Net Debt divided by trailing twelve months Adjusted EBITDA. The company believes Net Debt is an indicator of the extent to which the company’s outstanding debt obligations could be satisfied by cash on hand and a useful metric for investors to evaluate the company’s leverage position. The company believes the leverage ratio is a commonly used metric that management and investors use to assess the borrowing capacity of the company. The company believes total long-term debt (including the current portion) is the financial measure calculated and presented in accordance with U.S. generally accepted accounting principles that is most directly comparable to Net Debt.



Posted on

AnaptysBio Announces Second Quarter 2023 Financial Results and Provides Business Update

  • Completed enrollment of the GEMINI-1 Phase 3 trial for imsidolimab (IL-36R) in generalized pustular psoriasis (GPP) and anticipate top-line data in Q4 2023
  • Initiating a global Phase 2b trial for rosnilimab, a PD-1 agonist antibody, in rheumatoid arthritis (RA) later in Q3 2023 and a second Phase 2 trial, in an indication yet to be announced, by year-end 2023
  • Daniel Faga appointed to the permanent position of president and chief executive officer
  • Reiterating cash runway through year-end 2026 and updated expected year-end 2023 cash and investments of $380 – $395 million

SAN DIEGO, Aug. 07, 2023 (GLOBE NEWSWIRE) — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported operating results for the second quarter ended June 30, 2023 and provided a business update.

“We have made substantial operating progress including initiating a Phase 2b trial in atopic dermatitis (AD) for ANB032, our BTLA agonist, and approaching initiation of a Phase 2b trial in RA for rosnilimab, our PD-1 agonist,” said Daniel Faga, president and chief executive officer of AnaptysBio. “Additionally, we are excited to share that we recently completed enrollment of the GEMINI-1 Phase 3 clinical trial for imsidolimab in GPP and expect to share top-line data in Q4 2023.”

“We are excited to appoint Dan Faga to the permanent position of president and CEO,” said Jamie Topper, M.D., Ph. D., chairman of the Board of Directors. “Over the last year, Anaptys has completed its strategic portfolio review and Dan led the transition refocusing on the broad development of our differentiated immune cell modulators, including our checkpoint agonist pipeline, in autoimmune and inflammatory diseases. With Dan and his talented team in place, and our strong capital position, the company is well positioned as it enters its next phase of development and growth.”


Updates on Wholly Owned Immune Cell Modulator Pipeline

ANB032 (BTLA agonist antibody)

  • Initiated a global Phase 2b trial in moderate-to-severe AD
    • 160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and six-month follow-up period on well established endpoints, including EASI75 and IGA 0/1
    • Top-line week 14 data anticipated by year-end 2024
  • Hosted a virtual BTLA Agonist (ANB032) R&D Event in May 2023
    • Replay of the audio webcast is available here

Rosnilimab (PD-1 agonist antibody)

  • Anticipate initiation later in Q3 2023 of a global Phase 2b trial in moderate-to-severe RA
    • Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for up to six months on well-established endpoints including ACR20/50/70 and DAS28
    • Top-line week 12 data anticipated by mid-year 2025
  • Plan to initiate a second global Phase 2 trial, in a yet to-be-announced indication, by year-end 2023
  • Plan to host a virtual PD-1 Agonist (rosnilimab) R&D Event in Q4 2023

ANB033 (anti-CD122 antagonist antibody)

  • Presented poster on preclinical data for ANB033, an anti-CD122 antagonist for the treatment of inflammatory diseases, at the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, in June 2023
    • Poster presentation is available here
  • Plan to submit an Investigational New Drug (IND) application in H1 2024


Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

  • Completed enrollment of the GEMINI-1 Phase 3 trial for imsidolimab (IL-36R) in GPP per the initial target enrollment (n=45)
    • Top-line data anticipated in Q4 2023
  • Plan to out-license imsidolimab prior to potential FDA approval


Updates on GSK Immuno-Oncology Financial Collaboration

  • GSK received U.S FDA approval for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer on July 31, 2023
    • Jemperli is the first immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy
  • GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
  • GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy


Organizational Updates

  • Announced appointment of Daniel Faga to the permanent position of president and chief executive officer of the Company
    • Mr. Faga will retain his position on the Company’s Board of Directors
  • Announced appointments of Luisa Salter-Cid, Ph.D., and Dolca Thomas, M.D., to the Company’s Scientific Advisory Board (SAB)
    • Dr. Salter-Cid is the current chief scientific officer at Pioneering Medicines, a strategic initiative within Flagship Pioneering. She had extensive experience at Bristol-Meyers Squibb where she led teams that advanced more than 20 compounds into clinical development.
    • Dr. Thomas is currently a venture partner at Samsara BioCapital and serves on the Board of Directors of Allakos Therapeutics, Chinook Therapeutics and Ventus Therapeutics. Dr. Thomas has extensive experience in both large pharma and biotech. Among her prior roles includes serving as Principia’s chief medical officer from 2018 until the Sanofi acquisition in September 2020. Dr. Thomas was also vice president and global head of Translational Medicine for Immunology, Inflammation, and Infectious Disease at Roche, where she was responsible for advancing multiple product candidates through clinical development.
    • Read their full bios here

Year-End Cash Guidance

  • Reiterating cash runway through year-end 2026 with updated expected year-end 2023 cash and investments of $380 – $395 million

Second Quarter Financial Results

  • Cash, cash equivalents and investments totaled $488.7 million as of June 30, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $95.5 million. The decrease relates primarily to cash used for the $50 million stock repurchase program and operating activities.
  • Collaboration revenue was $3.5 million and $4.8 million for the three and six months ended June 30, 2023, compared to $1.2 million and $2.2 million for the three and six months ended June 30, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli.
  • Research and development expenses were $32.9 million and $67.9 million for the three and six months ended June 30, 2023, compared to $20.8 million and $43.4 million for the three and six months ended June 30, 2022. The increase was due primarily to manufacturing and development costs for imsidolimab, rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.7 million and $5.5 million for the three and six months ended June 30, 2023 as compared to $1.8 million and $3.4 million in the same period in 2022.
  • General and administrative expenses were $10.7 million and $21.5 million for the three and six months ended June 30, 2023, compared to $8.2 million and $18.4 million for the three and six months ended June 30, 2022. The G&A non-cash, stock-based compensation expense was $5.7 million and $11.8 million for the three and six months ended June 30, 2023 as compared to $4.9 million and $11.0 million in the same period in 2022.
  • Net loss was $39.8 million and $84.1 million for the three and six months ended June 30, 2023, or a net loss per share of $1.50 and $3.08, compared to a net loss of $32.6 million and $68.8 million for the three and six months ended June 30, 2022, or a net loss per share of $1.15 and $2.46.

About AnaptysBio

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, its PD-1 agonist, in a planned Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, its BTLA agonist, currently in a Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of initiation of the company’s clinical trials, including rosnilimab’s clinical trial in rheumatoid arthritis and in a second indication; the timing of the release of data from the company’s clinical trials, including imsidolimab’s Phase 3 clinical trial in GPP, rosnilimab’s Phase 2b clinical trial in rheumatoid arthritis and ANB032’s Phase 2b clinical trial in atopic dermatitis; the timing of ANB033’s IND filing; timing of the release of data from GSK’s clinical trials; the company’s ability to find a licensing partner for imsidolimab or etokimab and the timing of any such transaction; and the company’s projected cash runway. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Contact:

Nick Montemarano
Senior Director, Investor Relations and Strategic Communications
AnaptysBio, Inc.
858.732.0178
[email protected]

AnaptysBio, Inc.
Consolidated Balance Sheets
(in thousands, except par value data)
(unaudited)
    June 30, 2023   December 31, 2022
         
ASSETS
Current assets:        
Cash and cash equivalents   $ 35,206     $ 71,308  
Receivables from collaborative partners     3,182       1,419  
Short-term investments     394,280       369,933  
Prepaid expenses and other current assets     5,867       4,545  
Total current assets     438,535       447,205  
Property and equipment, net     2,023       2,089  
Operating lease right-of-use assets     17,047       17,898  
Long-term investments     59,239       142,935  
Other long-term assets     256       256  
Total assets   $ 517,100     $ 610,383  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:        
Accounts payable   $ 4,761     $ 2,784  
Accrued expenses     35,164       21,633  
Current portion of operating lease liability     1,706       1,637  
Total current liabilities     41,631       26,054  
Liability related to sale of future royalties     310,073       304,413  
Operating lease liability, net of current portion     16,946       17,813  
Stockholders’ equity:        
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at June 30, 2023 and December 31, 2022, respectively     —       —  
Common stock, $0.001 par value, 500,000 shares authorized, 26,531 shares and 28,513 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively     27       29  
Additional paid in capital     686,611       717,797  
Accumulated other comprehensive loss     (3,611 )     (5,246 )
Accumulated deficit     (534,577 )     (450,477 )
Total stockholders’ equity     148,450       262,103  
Total liabilities and stockholders’ equity   $ 517,100     $ 610,383  

AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
    Three Months Ended

June 30, 		  Six Months Ended

June 30,
      2023       2022       2023       2022  
Collaboration revenue   $ 3,460     $ 1,216     $ 4,834     $ 2,186  
Operating expenses:                
Research and development     32,923       20,844       67,880       43,360  
General and administrative     10,680       8,171       21,498       18,374  
Total operating expenses     43,603       29,015       89,378       61,734  
Loss from operations     (40,143 )     (27,799 )     (84,544 )     (59,548 )
Other income (expense), net:                
Interest income     4,653       1,107       9,139       1,449  
Non-cash interest expense for the sale of future royalties     (4,358 )     (5,868 )     (8,694 )     (10,722 )
Other income (expense), net     3       6       (1 )     12  
Total other income (expense), net     298       (4,755 )     444       (9,261 )
Net loss     (39,845 )     (32,554 )     (84,100 )     (68,809 )
Unrealized (loss) gain on available for sale securities     (344 )     (1,427 )     1,635       (3,439 )
Comprehensive loss   $ (40,189 )   $ (33,981 )   $ (82,465 )   $ (72,248 )
Net loss per common share:                
Basic and diluted   $ (1.50 )   $ (1.15 )   $ (3.08 )   $ (2.46 )
Weighted-average number of shares outstanding:                
Basic and diluted     26,629       28,204       27,288       27,960