Sangamo Therapeutics Reports Recent Business Highlights and First Quarter 2021 Financial Results

Sangamo Therapeutics Reports Recent Business Highlights and First Quarter 2021 Financial Results

Conference Call and Webcast Scheduled for 5:00 p.m. Eastern Time

BRISBANE, Calif.–(BUSINESS WIRE)–
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today reported recent business highlights and first quarter 2021 financial results.

“This quarter, we have continued our focus on advancing our lead programs through clinical execution, regulatory interactions, and collaborations with our partners and investigators. We are pleased that enrollment has completed for Pfizer’s lead-in study for the hemophilia A Phase 3 AFFINE trial. Additionally, the EMA granted Orphan Designation and the FDA granted Fast Track Designation to BIVV003, now known as SAR445136, our cell therapy product candidate treating sickle cell disease partnered with Sanofi. Also, we initiated the STEADFAST study for our product candidate treating renal transplant rejection, which we believe is the first-in-human CAR-Treg clinical study,” said Sandy Macrae, Chief Executive Officer of Sangamo. “Further, our research engine continued to be highly productive this quarter, advancing both our CAR-Treg programs for autoimmune disorders and our transcriptional regulation therapies for neurological diseases.”

Recent Business Highlights

  • Completed enrollment of patients in Pfizer’s lead-in study to the registrational Phase 3 AFFINE clinical trial of giroctocogene fitelparvovec, a gene therapy product candidate for the treatment of severe hemophilia A, developed in collaboration with Pfizer.
  • Received Fast Track Designation from the FDA for BIVV003, now known as SAR445136, our cell therapy product candidate for the treatment of sickle cell disease, developed in collaboration with Sanofi. Also, the EMA granted Orphan Designation to SAR445136 based on early clinical data from three treated patients.
  • Initiated the Phase 1/2 STEADFAST clinical study evaluating TX200, a wholly-owned autologous HLA-A2 CAR-Treg cell therapy product candidate treating patients receiving a HLA-A2 mismatched kidney from a living donor. The first patient is expected to be enrolled in this study by the end of this year.
  • Published preclinical data on tau- and alpha-synuclein-targeted zinc finger transcriptional repressors in Science Advances and at the 15th International Conference on Alzheimer’s & Parkinson’s Diseases (ADPD), respectively. Also, announced upcoming preclinical alpha-synuclein and C9ORF72 abstracts to be presented at the upcoming 24th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) on May 11, 2021.

First Quarter 2021 Financial Results

Consolidated net loss for the first quarter ended March 31, 2021 was $45.9 million or $0.32 per share, compared to a net loss of $42.9 million or $0.37 per share for the same period in 2020.

Revenues

Revenues for the first quarter ended March 31, 2021 were $26.3 million, compared to $13.1 million for the same period in 2020. The increase of $13.2 million in revenues was primarily due to the recognition of upfront license fees and research reimbursements under our collaboration agreements with Biogen and Novartis, which became effective in April and July 2020, respectively. These increases were partially offset by a decrease in revenue related to our hemophilia A collaboration with Pfizer, as a result of completion of our reimbursable activities in the fourth quarter of 2020.

GAAP and Non-GAAP operating expenses

Three Months Ended
March 31,
(In millions)

2021

2020

 
Research and development

$

56.5

 

$

41.5

 

General and administrative

 

16.1

 

 

16.1

 

Total operating expenses

 

72.6

 

 

57.6

 

Stock-based compensation expense

 

(7.5

)

 

(5.6

)

Non-GAAP operating expenses

$

65.1

 

$

52.0

 

Total operating expenses on a GAAP basis for the first quarter ended March 31, 2021 were $72.6 million compared to $57.6 million for the same period in 2020. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the first quarter ended March 31, 2021 were $65.1 million compared to $52.0 million for the same period in 2020.

The increase in total operating expenses on a GAAP basis was primarily driven by our higher clinical and manufacturing supply expenses to support the advancement of our clinical trials and our new collaborations along with our increased headcount.

Cash, cash equivalents and marketable securities

Cash, cash equivalents and marketable securities as of March 31, 2021 were $629.5 million compared to $692.0 million as of December 31, 2020.

Guidance for 2021 Reiterated (initial guidance provided on February 24, 2021)

On a GAAP basis, we expect total operating expenses, including non-cash stock-based compensation expenses, to be in the range of approximately $285 million to $305 million.

On a non-GAAP basis, we expect total operating expenses, excluding estimated non-cash stock-based compensation expense of approximately $30 million, to be in the range of approximately $255 million to $275 million.

Conference Call

Sangamo will host a conference call today, May 4, 2021, at 5:00 p.m. Eastern Time, which will be open to the public. The call will also be webcast with live Q&A and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 5714729. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 5714729.

About Sangamo Therapeutics

Sangamo Therapeutics is committed to translating ground-breaking science into genomic medicines with the potential to transform patients’ lives using gene therapy, cell therapy, and genome engineering. For more information about Sangamo, visit www.sangamo.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding our current expectations. These forward-looking statements include, without limitation, statements relating to advancing our clinical programs, the therapeutic potential of our product candidates, anticipated plans and timeline for enrolling and conducting clinical trials, our 2021 financial guidance related to GAAP and non-GAAP total operating expenses and stock-based compensation and other statements that are not historical fact. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the effects of the evolving COVID-19 pandemic and the impacts of the pandemic on the global business environment, healthcare systems and business and operations of Sangamo and our collaborators, including the initiation and operation of clinical trials; the research and development process, including the enrollment, operation and results of clinical trials; and our ability to achieve expected future financial performance.

There can be no assurance that we and our collaborators will be able to develop commercially viable products. Actual results may differ materially from those projected in these forward-looking statements due to the risks and uncertainties described above and other risks and uncertainties that exist in the operations and business environments of Sangamo and our collaborators. These risks and uncertainties are described more fully in our Securities and Exchange Commission filings and reports, including in our Annual Report on Form 10-K for the year ended December 31, 2020. Forward-looking statements contained in this announcement are made as of this date, and we undertake no duty to update such information except as required under applicable law.

Non-GAAP Financial Measure

To supplement our financial results and guidance presented in accordance with GAAP, we present non-GAAP total operating expenses, which exclude stock-based compensation expense from GAAP total operating expenses. We believe that this non-GAAP financial measure, when considered together with our financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare our results from period to period and to our forward-looking guidance, and to identify operating trends in our business. We have excluded stock-based compensation expense because it is a non-cash expense that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. This non-GAAP financial measure is in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business.

SELECTED CONSOLIDATED FINANCIAL DATA
(unaudited; in thousands, except per share data)
 
 
Statement of Operations Data:
Three months ended
March 31,

2021

2020

 
Revenues

$

26,280

 

$

13,076

 

Operating expenses:
Research and development

 

56,434

 

 

41,479

 

General and administrative

 

16,148

 

 

16,119

 

Total operating expenses

 

72,582

 

 

57,598

 

Loss from operations

 

(46,302

)

 

(44,522

)

Interest and other income, net

 

625

 

 

1,548

 

Loss before taxes

 

(45,677

)

 

(42,974

)

Income tax expense

 

262

 

 

 

Net loss

 

(45,939

)

 

(42,974

)

Net loss attributable to non-controlling interest

 

(6

)

 

(61

)

Net loss to Sangamo Therapeutics, Inc. stockholders

$

(45,933

)

$

(42,913

)

Basic and diluted net loss per share attributable to Sangamo Therapeutics, Inc. stockholders

$

(0.32

)

$

(0.37

)

Shares used in computing basic and diluted net loss per share attributable to Sangamo Therapeutics, Inc. stockholders

 

143,112

 

 

116,060

 

 
 
Selected Balance Sheet Data:

March 31, 2021

December 31, 2020

 
Cash, cash equivalents and marketable securities

$

629,515

 

$

691,953

 

Total assets

$

877,095

 

$

938,550

 

Total stockholders’ equity

$

469,417

 

$

497,366

 

 

Investor Relations & Media Inquiries

Aron Feingold

628.252.7494

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Health Genetics Research Pharmaceutical Science Biotechnology

MEDIA:

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Limoneira’s Joint Venture with Lewis Group of Companies Announces Additional Lot Closings of 36 Residential Units with National Home Builder Richmond American Homes

Limoneira’s Joint Venture with Lewis Group of Companies Announces Additional Lot Closings of 36 Residential Units with National Home Builder Richmond American Homes

Joint Venture Has Now Closed 464 Residential Unit Sales

SANTA PAULA, Calif.–(BUSINESS WIRE)–
Limoneira Company (the “Company” or “Limoneira”) (Nasdaq: LMNR), a diversified citrus growing, packing, selling and marketing company with related agribusiness activities and real estate development operations, announced today that its 50%/50% real estate development joint venture with The Lewis Group of Companies (“Lewis”) has closed an additional 36 residential homesites. These homesites were purchased by Richmond American Homes of Maryland, which operates in California and was one of the primary builders in Phase 1 of the Company’s Harvest at Limoneira project, which is currently comprised of 586 residential units.,

Harold Edwards, President and Chief Executive Officer, stated, “We are very pleased to announce these additional 36 lot closings with our respected guest builder, Richmond American Homes. We have now announced an additional 122 lot closing in fiscal 2021 and expect additional closing announcements in the near future.”

Including today’s announcement, Richmond Homes has now purchased a total of 78 single-family homesites within Harvest at Limoneira for the builder’s Beechtree community, which offers three distinctive floor plans with sought-after architectural and design options.

Harvest at Limoneira is a well-balanced, comprehensively designed master planned community near the Pacific Ocean. Boasting scenic views, and close proximity to parks, hiking trails and popular retail destinations, this exceptional community continues to attract strong interest from families throughout Southern California.

About M.D.C. Holdings, Inc.

Operating under the name Richmond American Homes, MDC’s homebuilding subsidiaries have built more than 210,000 homes since 1977. Among the nation’s largest homebuilders, MDC’s subsidiary companies have operations in Arizona, California, Colorado, Florida, Idaho, Maryland, Nevada, Oregon, Pennsylvania, Utah, Virginia and Washington. Mortgage lending, plus insurance and title services are offered by the following MDC subsidiaries, respectively: HomeAmerican Mortgage Corporation, American Home Insurance Agency, Inc. and American Home Title and Escrow Company. M.D.C. Holdings, Inc. is traded on the New York Stock Exchange under the symbol “MDC.” For more information, visit MDCHoldings.com.

About Limoneira Company

Limoneira Company, a 127-year-old international agribusiness headquartered in Santa Paula, California, has grown to become one of the premier integrated agribusinesses in the world. Limoneira (lē moñ âra) is a dedicated sustainability company with 15,400 acres of rich agricultural lands, real estate properties, and water rights in California, Arizona, Chile and Argentina. The Company is a leading producer of lemons, avocados, oranges, specialty citrus and other crops that are enjoyed throughout the world. For more about Limoneira Company, visit www.limoneira.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based on Limoneira’s current expectations about future events and can be identified by terms such as “expect,” “may,” “anticipate,” “intend,” “should be,” “will be,” “is likely to,” “strive to,” and similar expressions referring to future periods.

Limoneira believes the expectations reflected in the forward-looking statements are reasonable but cannot guarantee future results, level of activity, performance or achievements. Actual results may differ materially from those expressed or implied in the forward-looking statements. Therefore, Limoneira cautions you against relying on any of these forward-looking statements. Factors that may cause future outcomes to differ materially from those foreseen in forward-looking statements include, but are not limited to: additional impacts from the current COVID-19 pandemic, changes in laws, regulations, rules, quotas, tariffs and import laws; weather conditions that affect production, transportation, storage, import and export of fresh product; increased pressure from crop disease, insects and other pests; disruption of water supplies or changes in water allocations; pricing and supply of raw materials and products; market responses to industry volume pressures; pricing and supply of energy; changes in interest and currency exchange rates; availability of financing for land development activities; political changes and economic crises; international conflict; acts of terrorism; labor disruptions, strikes or work stoppages; loss of important intellectual property rights; inability to pay debt obligations; inability to engage in certain transactions due to restrictive covenants in debt instruments; government restrictions on land use; and market and pricing risks due to concentrated ownership of stock. Other risks and uncertainties include those that are described in Limoneira’s SEC filings that are available on the SEC’s website at http://www.sec.gov. Limoneira undertakes no obligation to subsequently update or revise the forward-looking statements made in this press release, except as required by law.

Investors:

John Mills

Managing Partner

ICR 646-277-1254

Corporate Communications:

Michael Gonzales

Marketing Manager

Limoneira Company

805-525-5541 ext. 1069

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Natural Resources Other Construction & Property Residential Building & Real Estate Other Natural Resources Construction & Property

MEDIA:

Oncocyte to Report First Quarter 2021 Financial Results on Monday, May 17

IRVINE, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, today announced that it will release its financial and operating results for the first quarter ended March 31, 2021, on Monday, May 17, 2021, after the close of the U.S. financial markets. The Company will host a conference call on Monday, May 17, 2021, at 4:30 pm ET / 1:30 pm PT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13719464. To access the live webcast, go to the investor relations section on the Company’s website, or by clicking here: http://public.viavid.com/index.php?id=144784.

About Oncocyte Corporation

Oncocyte is a molecular diagnostics company whose mission is to provide actionable answers at critical decision points across the cancer care continuum. The Company, through its proprietary tests and pharmaceutical services business, aims to help save lives and improve outcomes by accelerating and optimizing the diagnosis and treatment of cancer. The Company’s tests and services present multiple opportunities to advance cancer care while also driving revenue growth for the Company. Oncocyte launched DetermaRx™, a test that identifies early-stage lung cancer patients who are at high risk for cancer recurrence post-resection and predicts benefit from adjuvant chemotherapy. Oncocyte has also launched DetermaIO™, a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, as a research use only tool for pharmaceutical and academic clinical trials. To complement DetermaIO™, the Company anticipates launching DetermaTx™, a test to assess mutational status of a tumor to help identify the appropriate targeted therapy, in the second half of 2021. The Company recently completed the acquisition of Chronix Biomedical Inc. and its TheraSure™ CNI Monitor test, and also plans to continue with the development of DetermaMx™ as the Company seeks to expand into the blood-based monitoring market. Oncocyte’s pharmaceutical services provide pharmaceutical companies who are developing new cancer treatments a full suite of molecular testing services to support the drug development process.

DetermaRx, DetermaIO, DetermaMx, and DetermaTx are trademarks of Oncocyte Corporation.

Oncocyte Forward Looking Statements. Oncocyte cautions you that this press release contains forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements. These statements include those pertaining to the data to be presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, the potential use of DetermaIO across multiple tumor types, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, the potential impact of COVID-19 on our or any distributor’s financial and operational results, risks inherent in the development and/or commercialization of potential diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of our third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to our or any distributor’s supply chain, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, and the need to obtain third party reimbursement for patients’ use of any diagnostic tests we commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, greater than estimated allocations of resources to develop and commercialize technologies, or failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contact
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
[email protected]

Media Contact
Terri Clevenger
Westwicke/ICR
203-856-4326
[email protected]

Source: Oncocyte Corporation



MSCI Published an Investor Presentation

MSCI Published an Investor Presentation

NEW YORK–(BUSINESS WIRE)–
MSCI Inc. (“MSCI” or the “Company”) (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community, published a presentation for investors on its website, ir.msci.com, on Tuesday, May 4, 2021. The Company’s management team may use this presentation during meetings with investors.

About MSCI Inc.

MSCI is a leading provider of critical decision support tools and services for the global investment community. With over 50 years of expertise in research, data and technology, we power better investment decisions by enabling clients to understand and analyze key drivers of risk and return and confidently build more effective portfolios. We create industry-leading, research-enhanced solutions that clients use to gain insight into and improve transparency across the investment process.

To learn more, please visit www.msci.com. MSCI#IR

Investor Inquiries

[email protected]

Salli Schwartz +1 212 804 5306

Media Inquiries

[email protected]

Sam Wang +1 212 804 5244

Melanie Blanco +1 212 981 1049

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Technology Finance Public Relations/Investor Relations Consulting Banking Communications Professional Services Software Networks Data Management

MEDIA:

Eledon Pharmaceuticals to Release First Quarter Financial Results on Thursday, May 13, 2021

Management to host conference call and webcast at 4:30 pm ET

IRVINE, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals (“Eledon”) (NASDAQ: ELDN), a clinical stage biopharmaceutical company focused on developing life-changing, targeted medicines for persons living with autoimmune disease, requiring an organ or cell-based transplant, or living with amyotrophic lateral sclerosis (ALS), today announced that it plans to release financial results for the first quarter ended March 31, 2021 on Thursday, May 13, after the close of trading. Eledon’s management team will host a conference call and webcast beginning at 4:30 pm ET.

Conference Call and Webcast Details:

Thursday, May 13, 2021 at 4:30 PM Eastern Time / 1:30 PM Pacific Time
Toll Free: 800-709-0218 
International: 212-231-2926 
Conference ID: 21994011
Webcast: https://ir.eledon.com/events-and-presentations/events

After the live webcast, the event will be archived on Eledon’s website for one year.

About Eledon Pharmaceuticals and AT-1501

Eledon Pharmaceuticals is a clinical stage biotechnology company using its expertise in targeting the CD40L pathway to develop potential treatments for patients living with an autoimmune disease, patients requiring an organ or cell-based transplant, and for patients living with ALS. The company’s lead compound in development is AT-1501, an anti-CD40L antibody with high affinity for CD40 ligand (CD40L, also called CD154), a well-validated biological target with broad therapeutic potential. AT-1501 is a humanized IgG1 antibody engineered to potentially both improve safety and provide pharmacokinetic, pharmacodynamic, and dosing advantages compared to other anti-CD40 approaches. The CD40L/CD40 pathway is widely recognized for its prominent role in immune regulation. CD40L is primarily expressed on activated CD4+ T cells, platelets and endothelial cells while the CD40 receptor is constitutively expressed on antigen presenting cells such as B cells, macrophages, and dendritic cells. By blocking CD40L and not the CD40 receptor, AT-1501 inhibits both the CD40 and CD11 costimulatory signaling pathways, providing the potential for improved efficacy compared to anti-CD40 receptor approaches. Blocking CD40L also increases polarization of CD4+ lymphocytes to Tregs, a specialized subpopulation of T cells that act to suppress an immune response, thus creating a more tolerogenic environment, which may also play a therapeutic role for autoimmune diseases and in the transplant setting. Eledon is headquartered in Irvine, Calif. For more information, please visit the company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: @Eledon_Pharma and LinkedIn.

Investor Contact:

Corey Davis, Ph.D.
LifeSci Advisors, LLC
[email protected]
212.915.2577

Source: Eledon Pharmaceuticals



Cerus Corporation Announces First Quarter 2021 Financial Results and Raises Full Year Product Revenue Guidance

Cerus Corporation Announces First Quarter 2021 Financial Results and Raises Full Year Product Revenue Guidance

CONCORD, Calif.–(BUSINESS WIRE)–
Cerus Corporation (Nasdaq: CERS) today announced financial results for the first quarter ended March 31, 2021.

Recent developments and highlights include:

  • First quarter 2021 total revenue of $29.6 million, reflecting a 20% increase over the prior year period. Total revenue was composed of (in millions, except %):
     

 

 

Three Months Ended

 

 

     

 

March 31,

 

 

     

 

 

2021

 

 

2020

 

Change

     

Product revenue

 

$

23.4

 

$

18.6

 

26

%

     

Government contract revenue

 

 

6.2

 

 

6.0

 

3

%

     

Total revenue

 

$

29.6

 

$

24.6

 

20

%

  • Increasing 2021 annual product revenue guidance range to $110 million to $114 million (from prior guidance of $106 million to $110 million), representing an approximately 20% to 24% increase over full year 2020 reported product revenue.
  • Multiple blood center partners have completed validation efforts and are now manufacturing INTERCEPT Fibrinogen Complex, with inventory ready for release to hospital customers.
  • The Centers for Medicare and Medicaid Services (CMS) published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, which recommended that Intercept Fibrinogen Complex be eligible for incremental payment via a New Technology Add-On Payment (NTAP) when performed in the hospital inpatient setting.
  • Third module (CMC Data) submitted for CE Mark for INTERCEPT red blood cells. Fourth and final module (Manufacturing) submission anticipated by end of Q2:21.
  • Cash, cash equivalents, and short-term investments of $132 million at March 31, 2021.

“On the heels of our strong 2020 performance, product revenue in the first quarter of $23.4 million exceeded our expectations,” said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. “As our U.S. customers continue to prepare for compliance with FDA’s guidance around the bacterial safety of platelets, demand for the INTERCEPT Blood System continues to build. The momentum we have in the U.S. market in particular gives us confidence that 2021 will be another year of strong growth for Cerus and we are increasing our full year product revenue guidance accordingly.”

Revenue

Product revenue during the first quarter of 2021 was $23.4 million, compared to $18.6 million during the same period in 2020. Product revenue growth during the quarter benefited from increased demand for INTERCEPT platelet products in the U.S., led by adoption from the top five blood center networks in the country.

First quarter government contract revenue was $6.2 million, compared to $6.0 million during the same period in 2020. First quarter government contract revenue is primarily comprised of funding from the Biomedical Advanced Research and Development Authority (BARDA) agreement for the development of the INTERCEPT Blood System for Red Cells. The total potential value of the current BARDA agreement is $214 million, with $72.7 million cumulatively invoiced to BARDA through March 31, 2021.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the first quarter of 2021 were 52.5% compared to 55.3% for the first quarter of 2020. The decrease in gross margin was tied to increased sales to our U.S. customers, who typically use our single dose platelet kits, which carry a less favorable gross margin contribution compared to our double dose kits, which are used more broadly outside of the U.S.

Operating Expenses

Total operating expenses for the first quarter of 2021 were $34.9 million compared to $31.7 million for the same period of the prior year.

Selling, general, and administrative (SG&A) expenses for the first quarter of 2021 totaled $19.2 million, compared to $15.9 million for the first quarter of 2020. The year-over-year increase in SG&A expenses was tied to incremental expenses associated with the launch of our INTERCEPT Fibrinogen Complex product as well as increased non-cash stock-based compensation expense.

Research and development (R&D) expenses for the first quarter of 2021 were $15.7 million, compared to $15.8 million for the first quarter of 2020. The Company continues to expect to incur costs associated with the development and testing of a new generation of INTERCEPT devices and disposable kits as well as the clinical development and pursuit of regulatory approval for the red blood cell system, among others.

Net Loss

Net loss for the first quarter of 2021 was $17.5 million, or $0.10 per basic and diluted share, compared to a net loss of $16.5 million, or $0.10 per basic and diluted share, for the first quarter of 2020. Non-cash stock-based compensation was higher by approximately $1.6 million during the first quarter of 2021 compared to the prior year period, contributing to the slightly higher net loss.

Balance Sheet

At March 31, 2021, the Company had cash, cash equivalents and short-term investments of $131.7 million, compared to $133.6 million at December 31, 2020.

Despite continued increased investments in inventory to meet customer demand, cash used for operations during Q1 2021 was narrower at $18.0 million compared to $19.8 million used during the prior year period. Offsetting this lower use were $15 million in term loan draws and $1.4 million in incremental draws from its revolving line of credit. At March 31, 2021, the Company had approximately $54.6 million in outstanding term loan debt and $9.9 million of borrowings under its revolving loan credit agreement, compared to $39.6 million in outstanding term loan debt and $8.5 million of borrowings under its revolving loan credit agreement at December 31, 2020.

Increasing 2021 Product Revenue Guidance

The Company now expects 2021 product revenue to be in the range of $110 million to $114 million, as compared to the prior range of $106 million to $110 million. The revised guidance range represents approximately 20% to 24% growth compared to 2020 reported product revenue.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at http://www.cerus.com/ir. Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8668508. The replay will be available approximately three hours after the call through May 18, 2021.

ABOUT CERUS

Cerus Corporation is dedicated solely to safeguarding the world’s blood supply and aims to become the preeminent global blood products company. Headquartered in Concord, California, the company develops and supplies vital technologies and pathogen-protected blood components to blood centers, hospitals, and ultimately patients who rely on safe blood. The INTERCEPT Blood System for platelets and plasma is available globally and remains the only pathogen reduction system with both CE mark and FDA approval for these two blood components. The INTERCEPT red blood cell system is under regulatory review in Europe, and in late-stage clinical development in the US. Also in the US, the INTERCEPT Blood System for Cryoprecipitation is approved for production of Pathogen Reduced Cryoprecipitated Fibrinogen Complex, a therapeutic product for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. For more information about Cerus, visit www.cerus.com and follow us on LinkedIn.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

Forward Looking Statements

Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and expected results, including statements relating to Cerus’ updated 2021 annual product revenue guidance, including Cerus’ expectations that 2021 will be year of strong growth; the anticipated submission of the fourth CE Mark module for INTERCEPT red blood cells and the anticipated timing thereof; potential regulatory approval for the red blood cell system; building demand for the INTERCEPT Blood System; the potential value of the current BARDA agreement;and other statements that are not historical fact. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation: risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, including the risks that Cerus may not (a) meet its 2021 annual product revenue guidance, (b) effectively launch and commercialize the INTERCEPT Blood System for Cryoprecipitation, (c) grow sales globally, including in its U.S. and European markets, and/or realize expected revenue contribution resulting from its U.S. and European market agreements, (d) realize meaningful and/or increasing revenue contributions from U.S. customers in the near term or at all, particularly since Cerus cannot guarantee the volume or timing of commercial purchases, if any, that its U.S. customers may make under Cerus’ commercial agreements with these customers, and/or (e) realize any revenue contribution from its pipeline product candidates, whether due to Cerus’ inability to obtain regulatory approval of its pipeline programs, or otherwise; risks associated with the ultimate duration and severity of the COVID-19 pandemic and resulting global economic and financial disruptions, and the current and potential future negative impacts to Cerus’ business operations and financial results such as the current and potential additional disruptions to the U.S. and EMEA blood supply resulting from the evolving effects of the COVID-19 pandemic; risks associated with Cerus’ lack of commercialization experience with the INTERCEPT Blood System for Cryoprecipitation and in the United States generally, and its ability to develop and maintain an effective and qualified U.S.-based commercial organization, as well as the resulting uncertainty of its ability to achieve market acceptance of and otherwise successfully commercialize the INTERCEPT Blood System in the United States, including as a result of licensure requirements that must be satisfied by U.S. customers prior to their engaging in interstate transport of blood components processed using the INTERCEPT Blood System; risks related to Fresenius Kabi’s efforts to assure an uninterrupted supply of platelet additive solution (PAS); risks related to how any future PAS supply disruption could affect INTERCEPT’s acceptance in the marketplace; risks related to how any future PAS supply disruption might affect current commercial contracts; risks related to Cerus’ ability to demonstrate to the transfusion medicine community and other health care constituencies that pathogen reduction, including INTERCEPT Fibrinogen Complex for the treatment and control of bleeding, and the INTERCEPT Blood System is safe, effective and economical; risks related to the uncertain and time-consuming development and regulatory process, including the risks that (a) Cerus may be unable to comply with the FDA’s post-approval requirements for the INTERCEPT Blood System, including by successfully completing required post-approval studies, which could result in a loss of U.S. marketing approval(s) for the INTERCEPT Blood System, (b) manufacturing site Biologics License Applications necessary for Cerus to begin distributing the INTERCEPT Blood System for Cryoprecipitation may not be obtained in a timely manner or at all, (c) Cerus may be unable to obtain CE Mark approval, or any other regulatory approvals, of the INTERCEPT red blood cell system in a timely manner or at all, and (d) that Cerus may otherwise be unable to obtain the requisite regulatory approvals to advance its pipeline programs and bring them to market in a timely manner or at all; risks associated with Cerus’ lack of experience in marketing products directly to hospitals and expertise complying with regulations governing finished biologics; risks associated with the uncertain nature of BARDA’s funding over which Cerus has no control as well as actions of Congress and governmental agencies that may adversely affect the availability of funding under Cerus’ BARDA agreement and/or BARDA’s exercise of any potential subsequent option periods, including in connection with the general economic environment and uncertainty associated with the evolving effects of the COVID-19 pandemic, such that the anticipated activities that Cerus expects to conduct with the funds available from BARDA may be further delayed or halted and that Cerus may not otherwise realize the total potential value under its agreement with BARDA; risks related to product safety, including the risk that the septic platelet transfusions may not be avoidable with the INTERCEPT Blood System; risks related to adverse market and economic conditions, including continued or more severe adverse fluctuations in foreign exchange rates and/or continued or more severe weakening in economic conditions resulting from the evolving effects of the COVID-19 pandemic or otherwise in the markets where Cerus currently sells and is anticipated to sell its products; Cerus’ reliance on third parties to market, sell, distribute and maintain its products; Cerus’ ability to maintain an effective, secure manufacturing supply chain, including the risks that (a) Cerus’ supply chain could be negatively impacted as a result of the evolving effects of the COVID-19 pandemic, (b) Cerus’ manufacturers could be unable to comply with extensive FDA and foreign regulatory agency requirements, and (c) Cerus may be unable to maintain its primary kit manufacturing agreement and its other supply agreements with its third party suppliers; Cerus’ ability to identify and obtain additional partners to manufacture the INTERCEPT Blood System for Cryoprecipitation; risks associated with Cerus’ ability to meet its debt service obligations and its need for additional funding; the impact of legislative or regulatory healthcare reforms that may make it more difficult and costly for Cerus to produce, market and distribute its products; risks related to future opportunities and plans, including the uncertainty of Cerus’ future capital requirements and its future revenues and other financial performance and results, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including under the heading “Risk Factors” in Cerus’ Annual Report on Form 10-K, filed with the SEC on February 25, 2021. In addition, to the extent that the COVID-19 pandemic adversely affects Cerus’ business and financial results, it may also have the effect of heightening many of the other risks and uncertainties described above. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Supplemental Tables

Three Months Ended

March 31,

2021 vs. 2020

Platelet Kit Growth

U.S.

51%

Rest of World

-7%

Worldwide

17%

 

Change in Calculated Number of Treatable Platelet Doses*

U.S.

53%

Rest of World

-9%

Worldwide

13%

* Dose treated calculation based on the number of kits sold and the product configuration (single, double, and triple dose kits)

CERUS CORPORATION

REVENUE BY REGION

(in thousands, except percentages)

 

 

Three Months Ended

 

 

 

 

 

March 31,

 

Change

 

 

2021

 

 

2020

 

$

 

%

Europe, Middle East and Africa

$

13,277

 

$

12,220

 

$

1,057

 

9

%

North America

 

9,664

 

 

6,077

 

 

3,587

 

59

%

Other

 

438

 

 

314

 

 

124

 

39

%

Total product revenue

$

23,379

 

$

18,611

 

$

4,768

 

26

%

CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands, except per share information)

 

Three Months Ended

March 31,

 

2021

 

 

2020

 

Product revenue

$

23,379

 

$

18,611

 

Cost of product revenue

 

11,095

 

 

8,320

 

Gross profit on product revenue

 

12,284

 

 

10,291

 

Government contract revenue

 

6,187

 

 

6,030

 

Operating expenses:

Research and development

 

15,748

 

 

15,810

 

Selling, general and administrative

 

19,170

 

 

15,913

 

Total operating expenses

 

34,918

 

 

31,723

 

Loss from operations

 

(16,447

)

 

(15,402

)

Total non-operating expense, net

 

(912

)

 

(1,007

)

Loss before income taxes

 

(17,359

)

 

(16,409

)

Provision for income taxes

 

98

 

 

57

 

Net loss

$

(17,457

)

$

(16,466

)

 

Net loss per share:

Basic and diluted

$

(0.10

)

$

(0.10

)

Weighted average shares used for calculating net loss per share:

Basic and diluted

 

168,824

 

 

157,405

 

CERUS CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

March 31,

December 31,

 

2021

2020*

ASSETS

(unaudited)

Current assets:

Cash and cash equivalents

$

57,607

$

36,594

Short-term investments

 

74,118

 

97,000

Accounts receivable

 

18,253

 

21,166

Inventories

 

24,285

 

23,254

Prepaid and other current assets

 

7,009

 

5,417

Total current assets

 

181,272

 

183,431

Non-current assets:

Property and equipment, net

 

13,283

 

13,867

Goodwill

 

1,316

 

1,316

Operating lease right-of-use assets

 

12,801

 

13,122

Restricted cash and other assets

 

11,910

 

9,679

Total assets

$

220,582

$

221,415

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$

42,284

$

48,966

Debt – current

 

9,938

 

8,516

Operating lease liabilities – current

 

1,486

 

1,915

Deferred product revenue – current

 

1,056

 

577

Total current liabilities

 

54,764

 

59,974

Non-current liabilities:

Debt – non-current

 

54,616

 

39,588

Operating lease liabilities – non-current

 

16,697

 

16,873

Other non-current liabilities

 

1,870

 

1,174

Total liabilities

 

127,947

 

117,609

Stockholders’ equity

 

92,635

 

103,806

Total liabilities and stockholders’ equity

$

220,582

$

221,415

* Derived from the audited consolidated financial statements.

 

Matt Notarianni – Senior Director, Investor Relations

Cerus Corporation

925-288-6137

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Medical Supplies Medical Devices Health Pharmaceutical Cardiology Biotechnology

MEDIA:

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NMI Holdings, Inc. Reports First Quarter 2021 Financial Results

EMERYVILLE, Calif., May 04, 2021 (GLOBE NEWSWIRE) — NMI Holdings, Inc. (Nasdaq: NMIH) today reported net income of $52.9 million, or $0.61 per diluted share, for the first quarter ended March 31, 2021, which compares to $48.3 million, or $0.56 per diluted share, in the fourth quarter ended December 31, 2020 and $58.3 million, or $0.74 per diluted share, in the first quarter ended March 31, 2020. Adjusted net income for the quarter was $53.4 million, or $0.62 per diluted share, which compares to $50.8 million, or $0.59 per diluted share, in the fourth quarter ended December 31, 2020 and $52.7 million, or $0.75 per diluted share, in the first quarter ended March 31, 2020. The non-GAAP financial measures adjusted net income, adjusted diluted earnings per share and adjusted return on equity are presented in this release to enhance the comparability of financial results between periods. See “Use of Non-GAAP Financial Measures” and our reconciliation of such measures to their most comparable GAAP measures, below.

Claudia Merkle, CEO of National MI, said, “We achieved record NIW volume, significant growth in our insured portfolio and strong financial performance in the first quarter. We helped more borrowers than ever before gain access to housing and continued to differentiate with our lender customers. Our credit performance remained favorable and we are increasingly optimistic as the stress of the COVID pandemic has begun to recede, the outlook for the economy has improved sharply and the housing market continues to strengthen.”

Selected first quarter 2021 highlights include:

  • New insurance written was $26.4 billion, up 33% compared to $19.8 billion in the fourth quarter and 134% compared to $11.3 billion in the first quarter of 2020
  • Primary insurance-in-force at quarter end was $123.8 billion, up 11% from $111.3 billion at the end of the fourth quarter and 26% compared to the first quarter of 2020
  • Net premiums earned were $105.9 million, up 5% compared to $100.7 million in the fourth quarter and 7% compared to $98.7 million in the first quarter of 2020
  • Underwriting and operating expenses were $34.1 million, including $378 thousand of capital market transaction costs, compared to $35.0 million in the fourth quarter and $32.3 million in the first quarter of 2020
  • Insurance claims and claim expenses were $5.0 million, compared to $3.5 million in the fourth quarter and $5.7 million in the first quarter of 2020
  • At quarter-end, cash and investments were $1.9 billion and shareholders’ equity was $1.4 billion, equal to $16.13 per share
  • Annualized return on equity for the quarter was 15.4% and annualized adjusted return on equity was 15.5%
  • At quarter-end, the company reported total PMIERs available assets of $1.8 billion and net risk-based required assets of $1.3 billion

Concurrent with the release of first quarter earnings, the company has filed a Form 8-K that includes selected operating statistics for the month ended April 30, 2021. Investors may access the Form 8-K on the company’s website, www.nationalmi.com, in the “Investor Relations” section.

   
Quarter
Ended


Quarter
Ended


Quarter
Ended


Change



(1)


Change



(1)

   
3/31/2021

12/31/2020

3/31/2020

Q/Q

Y/Y
INSURANCE METRICS ($billions)
Primary Insurance-in-Force $ 123.8   $ 111.3   $ 98.5   11 % 26 %
New Insurance Written – NIW          
  Monthly premium 23.8   17.8   10.5   34 % 127 %
  Single premium 2.6   2.0   0.8   32 % 215 %
  Total 26.4   19.8   11.3   33 % 134 %
           
FINANCIAL HIGHLIGHTS ($millions, except per share amounts)
Net Premiums Earned $ 105.9   $ 100.7   $ 98.7   5 % 7 %
Insurance Claims and Claim Expenses 5.0   3.5   5.7   40 % (13 )%
Underwriting and Operating Expenses 34.1   35.0   32.3   (3 )% 6 %
Net Income 52.9   48.3   58.3   10 % (9 )%
Adjusted Net Income 53.4   50.8   52.7   5 % 1 %
Cash and Investments   1,947     1,931     1,180   1 % 65 %
Shareholders’ Equity 1,380   1,370   975   1 % 42 %
Book Value per Share   16.13     16.08     14.15   % 14 %
Loss Ratio 4.7 % 3.5 % 5.8 %    
Expense Ratio 32.2 % 34.7 % 32.7 %    

(1) Percentages may not be replicated based on the rounded figures presented in the table.

Conference Call and Webcast Details

   
The company will hold a conference call, which will be webcast live today, May 4, 2021, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The webcast will be available on the company’s website, www.nationalmi.com, in the “Investor Relations” section. The conference call can also be accessed by dialing (888) 734-0328 in the U.S., or (914) 495-8578 internationally, and using Conference ID: 1887668 or by referencing NMI Holdings, Inc.

About NMI Holdings, Inc.

NMI Holdings, Inc. (NASDAQ: NMIH), is the parent company of National Mortgage Insurance Corporation (National MI), a U.S.-based, private mortgage insurance company enabling low down payment borrowers to realize home ownership while protecting lenders and investors against losses related to a borrower’s default. To learn more, please visit www.nationalmi.com.

Cautionary Note Regarding Forward-Looking Statements

Certain statements contained in this press release or any other written or oral statements made by or on behalf of the Company in connection therewith may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the U.S. Private Securities Litigation Reform Act of 1995 (the “PSLRA”). The PSLRA provides a “safe harbor” for any forward-looking statements. All statements other than statements of historical fact included in or incorporated by reference in this release are forward-looking statements, including any statements about our expectations, outlook, beliefs, plans, predictions, forecasts, objectives, assumptions or future events or performance. These statements are often, but not always, made through the use of words or phrases such as “anticipate,” “believe,” “can,” “could,” “may,” “predict,” “assume,” “potential,” “should,” “will,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “intend” and similar words or phrases. All forward-looking statements are only predictions and involve estimates, known and unknown risks, assumptions and uncertainties that may turn out to be inaccurate and could cause actual results to differ materially from those expressed in them. Many risks and uncertainties are inherent in our industry and markets. Others are more specific to our business and operations. Important factors that could cause actual events or results to differ materially from those indicated in such statements include, but are not limited to: uncertainty relating to the COVID-19 pandemic and the measures taken by governmental authorities and other third parties to combat it, including their impact on the global economy, the U.S. housing, real estate, housing finance and mortgage insurance markets, and the Company’s business, operations and personnel, changes in the business practices of Fannie Mae and Freddie Mac (collectively, the “GSEs”), including decisions that have the impact of decreasing or discontinuing the use of mortgage insurance as credit enhancement generally, or with first time homebuyers or on very high loan-to-value mortgages; our ability to remain an eligible mortgage insurer under the private mortgage insurer eligibility requirements (“PMIERs”) and other requirements imposed by the GSEs, which they may change at any time; retention of our existing certificates of authority in each state and the District of Columbia (“D.C.”) and our ability to remain a mortgage insurer in good standing in each state and D.C.; our future profitability, liquidity and capital resources; actions of existing competitors, including other private mortgage insurers and government mortgage insurers, such as the Federal Housing Administration, U.S. Department of Agriculture’s Rural Housing Service and the U.S. Department of Veterans Affairs, and potential market entry by new competitors or consolidation of existing competitors; developments in the world’s financial and capital markets and our access to such markets, including reinsurance; adoption of new or changes to existing laws and regulations that impact our business or financial condition directly or the mortgage insurance industry generally or their enforcement and implementation by regulators, including the timing and eventual implementation of the final rules concerning “Qualified Mortgage” and “Qualified Residential Mortgage” definitions and the expiration of the “QM Patch” under the Dodd-Frank Act Ability to Repay/Qualified Mortgage rule; legislative or regulatory changes to the GSEs’ role in the secondary mortgage market or other changes that could affect the residential mortgage industry generally or mortgage insurance industry in particular; potential future lawsuits, investigations or inquiries or resolution of current lawsuits or inquiries; changes in general economic, market and political conditions and policies, interest rates, inflation and investment results or other conditions that affect the housing market or the markets for home mortgages or mortgage insurance; our ability to successfully execute and implement our capital plans, including our ability to access the capital, credit and reinsurance markets and to enter into, and receive approval of, reinsurance arrangements on terms and conditions that are acceptable to us, the GSEs and our regulators; our ability to implement our business strategy, including our ability to write mortgage insurance on high quality low-down payment residential mortgage loans, implement successfully and on a timely basis, complex infrastructure, systems, procedures, and internal controls to support our business and regulatory and reporting requirements of the insurance industry; our ability to attract and retain a diverse customer base, including the largest mortgage originators; failure of risk management or pricing or investment strategies; emergence of unexpected claim and coverage issues, including claims exceeding our reserves or amounts we had expected to experience; potential adverse impacts arising from natural disasters, including, with respect to affected areas, a decline in new business, adverse effects on home prices, and an increase in notices of default on insured mortgages; the inability of our counterparties, including third party reinsurers, to meet their obligations to us; failure to maintain, improve and continue to develop necessary information technology systems or the failure of technology providers to perform; and, our ability to recruit, train and retain key personnel. These risks and uncertainties also include, but are not limited to, those set forth under the heading “Risk Factors” detailed in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2020, as subsequently updated through other reports we file with the SEC. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these cautionary statements. We caution you not to place undue reliance on any forward-looking statement, which speaks only as of the date on which it is made, and we undertake no obligation to publicly update or revise any forward-looking statement to reflect new information, future events or circumstances that occur after the date on which the statement is made or to reflect the occurrence of unanticipated events except as required by law.

Use of Non-GAAP Financial Measures

We believe the use of the non-GAAP measures of adjusted income before tax, adjusted net income, adjusted diluted EPS, adjusted return-on-equity, adjusted expense ratio and adjusted combined ratio enhances the comparability of our fundamental financial performance between periods, and provides relevant information to investors. These non-GAAP financial measures align with the way the company’s business performance is evaluated by management. These measures are not prepared in accordance with GAAP and should not be viewed as alternatives to GAAP measures of performance. These measures have been presented to increase transparency and enhance the comparability of our fundamental operating trends across periods. Other companies may calculate these measures differently; their measures may not be comparable to those we calculate and present.

Adjusted income before tax is defined as GAAP income before tax, excluding the pre-tax effects of the gain or loss related to the change in fair value of our warrant liability, periodic costs incurred in connection with capital markets transactions, net realized gains or losses from our investment portfolio, and discrete, non-recurring and non-operating items in the periods in which such items are incurred.

Adjusted net income is defined as GAAP net income, excluding the after-tax effects of the gain or loss related to the change in fair value of our warrant liability, periodic costs incurred in connection with capital markets transactions, net realized gains or losses from our investment portfolio, and discrete, non-recurring and non-operating items in the periods in which such items are incurred. Adjustments to components of pre-tax income are tax effected using the applicable federal statutory tax rate for the respective periods.

Adjusted diluted EPS is defined as adjusted net income divided by adjusted weighted average diluted shares outstanding. Adjusted weighted average diluted shares outstanding is defined as weighted average diluted shares outstanding, adjusted for changes in the dilutive effect of non-vested shares that would otherwise have occurred had GAAP net income been calculated in accordance with adjusted net income. There will be no adjustment to weighted average diluted shares outstanding in the periods that non-vested shares are anti-dilutive under GAAP.

Adjusted return on equity is calculated by dividing adjusted net income on an annualized basis by the average shareholders’ equity for the period.

Adjusted expense ratio is defined as GAAP underwriting and operating expenses, excluding the pre-tax effects of periodic costs incurred in connection with capital markets transactions, divided by net premiums earned.

Adjusted combined ratio is defined as the total of GAAP underwriting and operating expenses, excluding the pre-tax effects of periodic costs incurred in connection with capital markets transactions and insurance claims and claims expenses, divided by net premiums earned.

Although adjusted income before tax, adjusted net income, adjusted diluted EPS, adjusted return-on-equity, adjusted expense ratio and adjusted combined ratio exclude certain items that have occurred in the past and are expected to occur in the future, the excluded items: (1) are not viewed as part of the operating performance of our primary activities; or (2) are impacted by market, economic or regulatory factors and are not necessarily indicative of operating trends, or both. These adjustments, and the reasons for their treatment, are described below.

(1) Change in fair value of warrant liability. Outstanding warrants at the end of each reporting period are revalued, and any change in fair value is reported in the statement of operations in the period in which the change occurred. The change in fair value of our warrant liability can vary significantly across periods and is influenced principally by equity market and general economic factors that do not impact or reflect our current period operating results. We believe trends in our operating performance can be more clearly identified by excluding fluctuations related to the change in fair value of our warrant liability.

(2) Capital markets transaction costs. Capital markets transaction costs result from activities that are undertaken to improve our debt profile or enhance our capital position through activities such as debt refinancing and capital markets reinsurance transactions that may vary in their size and timing due to factors such as market opportunities, tax and capital profile, and overall market cycles.

(3) Net realized investment gains and losses. The recognition of the net realized investment gains or losses can vary significantly across periods as the timing is highly discretionary and is influenced by factors such as market opportunities, tax and capital profile, and overall market cycles that do not reflect our current period operating results.

(4) Infrequent or unusual non-operating items. Items that are the result of unforeseen or uncommon events, which occur separately from operating earnings and are not expected to recur in the future. Identification and exclusion of these items provides clarity about the impact special or rare occurrences may have on our current financial performance. Past adjustments under this category include the effects of the release of the valuation allowance recorded against our net federal and certain state net deferred tax assets in 2016 and the re-measurement of our net deferred tax assets in connection with tax reform in 2017. We believe such items are non-recurring in nature, are not part of our primary operating activities and do not reflect our current period operating results.

Investor Contact

John M. Swenson
Vice President, Investor Relations and Treasury
[email protected]
(510) 788-8417

Press Contact

Mary McGarity
Strategic Vantage Mortgage Public Relations
(203) 513-2721
[email protected]



Consolidated statements of operations and comprehensive income For the three months ended March 31,
  2021   2020
   
Revenues (In Thousands, except for per share data)
Net premiums earned $ 105,879     $ 98,717  
Net investment income 8,814     8,104  
Net realized investment losses     (72 )
Other revenues 501     900  
Total revenues 115,194     107,649  
Expenses      
Insurance claims and claim expenses 4,962     5,697  
Underwriting and operating expenses 34,065     32,277  
Service expenses 591     734  
Interest expense 7,915     2,744  
Loss (gain) from change in fair value of warrant liability 205     (5,959 )
Total expenses 47,738     35,493  
       
Income before income taxes 67,456     72,156  
Income tax expense 14,565     13,885  
Net income $ 52,891     $ 58,271  
       
Earnings per share      
Basic $ 0.62     $ 0.85  
Diluted $ 0.61     $ 0.74  
       
Weighted average common shares outstanding      
Basic 85,317     68,563  
Diluted 86,487     70,401  
       
Loss ratio(1) 4.7 %   5.8 %
Expense ratio(2) 32.2 %   32.7 %
Combined ratio 36.9 %   38.5 %
       
Net income $ 52,891     $ 58,271  
       
Other comprehensive loss, net of tax:      
Unrealized losses in accumulated other comprehensive loss, net of tax benefit of $11,997 and $3,424 for the quarters ended March 31, 2021 and 2020, respectively (45,133 )   (12,881 )
Reclassification adjustment for realized losses included in net income, net of tax benefit of $15 for the quarter ended March 31, 2020     57  
Other comprehensive loss, net of tax (45,133 )   (12,824 )
Comprehensive income $ 7,758     $ 45,447  

(1)   Loss ratio is calculated by dividing insurance claims and claim expenses by net premiums earned.
(2)   Expense ratio is calculated by dividing other underwriting and operating expenses by net premiums earned.

Consolidated balance sheets March 31, 2021   December 31, 2020
   
Assets (In Thousands, except for share data)
Fixed maturities, available-for-sale, at fair value (amortized cost of $1,815,190 and
$1,730,835 as of March 31, 2021 and December 31, 2020, respectively)
$ 1,831,511     $ 1,804,286  
Cash and cash equivalents (including restricted cash of $4,868 and $5,555 as of
March 31, 2021 and December 31, 2020, respectively)
115,517     126,937  
Premiums receivable 52,206     49,779  
Accrued investment income 10,495     9,862  
Prepaid expenses 4,999     3,292  
Deferred policy acquisition costs, net 62,294     62,225  
Software and equipment, net 31,298     29,665  
Intangible assets and goodwill 3,634     3,634  
Prepaid reinsurance premiums 4,842     6,190  
Reinsurance recoverable 18,686     17,608  
Other assets 52,349     53,188  
Total assets $ 2,187,831     $ 2,166,666  
       
Liabilities      
Debt $ 393,622     $ 393,301  
Unearned premiums 127,407     118,817  
Accounts payable and accrued expenses 57,139     61,716  
Reserve for insurance claims and claim expenses 96,103     90,567  
Reinsurance funds withheld 7,569     8,653  
Warrant liability, at fair value 4,239     4,409  
Deferred tax liability, net 115,150     112,586  
Other liabilities 6,294     7,026  
Total liabilities 807,523     797,075  
       
Shareholders’ equity      
Common stock – class A shares, $0.01 par value; 85,599,908 and 85,163,039 shares
issued and outstanding as of March 31, 2021 and December 31, 2020, respectively
(250,000,000 shares authorized)
856     852  
Additional paid-in capital 940,827     937,872  
Accumulated other comprehensive income, net of tax 8,723     53,856  
Retained earnings 429,902     377,011  
Total shareholders’ equity 1,380,308     1,369,591  
Total liabilities and shareholders’ equity $ 2,187,831     $ 2,166,666  

Non-GAAP Financial Measure Reconciliations
  Quarter ended   Quarter ended   Quarter ended
  3/31/2021   12/31/2020   3/31/2020
As Reported (In Thousands, except for per share data)
Revenues          
Net premiums earned $ 105,879     $ 100,709     $ 98,717  
Net investment income 8,814     8,386     8,104  
Net realized investment gains (losses)     295     (72 )
Other revenues 501     513     900  
Total revenues 115,194     109,903     107,649  
Expenses          
Insurance claims and claim expenses 4,962     3,549     5,697  
Underwriting and operating expenses 34,065     34,994     32,277  
Service expenses 591     459     734  
Interest expense 7,915     7,906     2,744  
Loss (gain) from change in fair value of warrant liability 205     1,379     (5,959 )
Total expenses 47,738     48,287     35,493  
           
Income before income taxes 67,456     61,616     72,156  
Income tax expense 14,565     13,348     13,885  
Net income $ 52,891     $ 48,268     $ 58,271  
           
Adjustments:          
Net realized investment (gains) losses     (295 )   72  
Loss (gain) from change in fair value of warrant liability 205     1,379     (5,959 )
Capital markets transaction costs 378     1,719     474  
Adjusted income before taxes 68,039     64,419     66,743  
           
Income tax expense on adjustments 79     299     115  
Adjusted net income $ 53,395     $ 50,772     $ 52,743  
           
Weighted average diluted shares outstanding 86,487     86,250     70,401  
           
Diluted EPS

(1)
$ 0.61     $ 0.56     $ 0.74  
Adjusted diluted EPS $ 0.62     $ 0.59     $ 0.75  
           
Return-on-equity 15.4 %   14.4 %   24.5 %
Adjusted return-on-equity 15.5 %   15.2 %   22.1 %
           
           
Expense ratio

(2)
32.2 %   34.7 %   32.7 %
Adjusted expense ratio

(3)
31.8 %   33.0 %   32.2 %
           
Combined ratio

(4)
36.9 %   38.3 %   38.5 %
Adjusted combined ratio

(5)
36.5 %   36.6 %   38.0 %

(1) Diluted net income for the quarter ended March 30, 2020, excludes the impact of the warrant fair value change as it was anti-dilutive. For all other periods presented, diluted net income equals reported net income as the impact of the warrant fair value change was dilutive.
(2) Expense ratio is calculated by dividing underwriting and operating expenses by net premiums earned.
(3) Adjusted expense ratio is calculated by dividing adjusted underwriting and operating expense (underwriting and operating expenses excluding costs related to capital markets reinsurance transactions) by net premiums earned.
(4) Combined ratio is calculated by dividing the total of underwriting and operating expenses and insurance claims and claims expense by net premiums earned.
(5) Adjusted combined ratio is calculated by dividing the total of adjusted underwriting and operating expenses (underwriting and operating expenses excluding costs related to capital market reinsurance transaction) and insurance claims and claims expense by net premiums earned.

Historical Quarterly Data 2021   2020   2019
  March 31   December 31   September 30   June 30   March 31   December 31
   
Revenues (In Thousands, except for per share data)
Net premiums earned $ 105,879     $ 100,709     $ 98,802     $ 98,944     $ 98,717     $ 95,517  
Net investment income 8,814     8,386     8,337     7,070     8,104     7,962  
Net realized investment gains (losses)     295     (4 )   711     (72 )   264  
Other revenues 501     513     648     1,223     900     1,154  
Total revenues 115,194     109,903     107,783     107,948     107,649     104,897  
Expenses                      
Insurance claims and claim expenses 4,962     3,549     15,667     34,334     5,697     4,269  
Underwriting and operating expenses 34,065     34,994     33,969     30,370     32,277     31,296  
Service expenses 591     459     557     1,090     734     937  
Interest expense 7,915     7,906     7,796     5,941     2,744     2,974  
Loss (gain) from change in fair value of warrant liability 205     1,379     437     1,236     (5,959 )   2,632  
Total expenses 47,738     48,287     58,426     72,971     35,493     42,108  
                       
Income before income taxes 67,456     61,616     49,357     34,977     72,156     62,789  
Income tax expense 14,565     13,348     11,178     8,129     13,885     12,594  
Net income $ 52,891     $ 48,268     $ 38,179     $ 26,848     $ 58,271     $ 50,195  
                       
Earnings per share                      
Basic $ 0.62     $ 0.57     $ 0.45     $ 0.36     $ 0.85     $ 0.74  
Diluted $ 0.61     $ 0.56     $ 0.45     $ 0.36     $ 0.74     $ 0.71  
                       
Weighted average common shares outstanding                      
Basic 85,317     84,956     84,805     73,617     68,563     68,140  
Diluted 86,487     86,250     85,599     74,174     70,401     70,276  
                       
Other data                      
Loss Ratio(1) 4.7 %   3.5 %   15.9 %   34.7 %   5.8 %   4.5 %
Expense Ratio(2) 32.2 %   34.7 %   34.4 %   30.7 %   32.7 %   32.8 %
Combined ratio (3) 36.9 %   38.3 %   50.2 %   65.4 %   38.5 %   37.2 %

(1)   Loss ratio is calculated by dividing insurance claims and claim expenses by net premiums earned.
(2)   Expense ratio is calculated by dividing underwriting and operating expenses by net premiums earned.
(3)   Combined ratio may not foot due to rounding.


Portfolio Statistics

The table below highlights trends in our primary portfolio as of the date and for the periods indicated.

Primary portfolio trends As of and for the three months ended
  March 31,
2021
  December 31,
2020
  September 30,
2020
  June 30, 2020   March 31,
2020
  December 31,
2019
  ($ Values In Millions, except as noted below)
New insurance written $ 26,397     $ 19,782     $ 18,499     $ 13,124     $ 11,297     $ 11,949  
New risk written 6,531     4,868     4,577     3,260     2,897     3,082  
Insurance in force (IIF) (1) 123,777     111,252     104,494     98,905     98,494     94,754  
Risk in force (1) 31,206     28,164     26,568     25,238     25,192     24,173  
Policies in force (count) (1) 436,652     399,429     381,899     372,934     376,852     366,039  
Average loan size ($ value in thousands)(1) $ 283     $ 279     $ 274     $ 265     $ 261     $ 259  
Coverage percentage (2) 25.2 %   25.3 %   25.4 %   25.5 %   25.6 %   25.5 %
Loans in default (count) (1) 11,090     12,209     13,765     10,816     1,449     1,448  
Default rate (1) 2.54 %   3.06 %   3.60 %   2.90 %   0.38 %   0.40 %
Risk in force on defaulted loans (1) $ 785     $ 874     $ 1,008     $ 799     $ 84     $ 84  
Net premium yield (3) 0.36 %   0.37 %   0.39 %   0.40 %   0.41 %   0.41 %
Earnings from cancellations $ 9.9     $ 11.7     $ 12.6     $ 15.5     $ 8.6     $ 8.0  
Annual persistency (4) 51.9 %   55.9 %   60.0 %   64.1 %   71.7 %   76.8 %
Quarterly run-off (5) 12.5 %   12.5 %   13.1 %   12.9 %   8.0 %   7.7 %

(1) Reported as of the end of the period.
(2) Calculated as end of period risk-in-force (RIF) divided by end of period IIF.
(3) Calculated as net premiums earned, divided by average primary IIF for the period, annualized.
(4) Defined as the percentage of IIF that remains on our books after a given twelve-month period.
(5) Defined as the percentage of IIF that is no longer on our books after a given three month period.


New Insurance Written (NIW), Insurance in Force (IIF) and Premiums

The tables below present primary NIW and primary and pool IIF, as of the dates and for the periods indicated.

Primary NIW Three months ended
  March 31, 2021   December 31,
2020
  September 30,
2020
  June 30, 2020   March 31, 2020   December 31,
2019
  (In Millions)
Monthly $ 23,764     $ 17,789     $ 16,516     $ 11,885     $ 10,461     $ 11,085  
Single 2,633     1,993     1,983     1,239     836     864  
Primary $ 26,397     $ 19,782     $ 18,499     $ 13,124     $ 11,297     $ 11,949  

Primary and pool IIF As of
  March 31, 2021   December 31,
2020
  September 30,
2020
  June 30, 2020   March 31, 2020   December 31,
2019
  (In Millions)
Monthly $ 106,920     $ 95,336     $ 88,584     $ 82,848     $ 81,347     $ 77,097  
Single 16,857     15,916     15,910     16,057     17,147     17,657  
Primary 123,777     111,252     104,494     98,905     98,494     94,754  
                       
Pool 1,642     1,855     2,115     2,340     2,487     2,570  
Total $ 125,419     $ 113,107     $ 106,609     $ 101,245     $ 100,981     $ 97,324  

The following table presents the amounts related to the company’s quota-share reinsurance transactions (the 2016 QSR Transaction, 2018 QSR Transaction, 2020 QSR Transaction and 2021 QSR Transaction, and collectively, the QSR Transactions), and Insurance-Linked Note transactions (the 2017 ILN Transaction, 2018 ILN Transaction, 2019 ILN Transaction, 2020-1 ILN Transaction and 2020-2 ILN Transaction, and collectively, the ILN Transactions) for the periods indicated.

  For the three months ended
  March 31,
2021
  December 31,
2020
  September 30,
2020
  June 30, 2020   March 31,
2020
  December 31,
2019
  (In Thousands)
The QSR Transactions                      
Ceded risk-in-force $ 6,330,409       $ 5,543,969       $ 5,159,061       $ 4,563,676       $ 4,843,715       $ 5,137,249    
Ceded premiums earned (25,747 )     (24,161 )     (24,517 )     (23,210 )     (23,011 )     (23,673 )  
Ceded claims and claim expenses 1,180       601       3,200       8,669       1,532       1,030    
Ceding commission earned 5,162       4,787       4,798       4,428       4,513       4,691    
Profit commission 13,380       13,184       11,034       5,271       12,413       13,314    
                       
The ILN Transactions                      
Ceded premiums $ (9,397 )     $ (9,422 )     $ (6,268 )     $ (3,267 )     $ (3,872 )     $ (4,263 )  

The tables below present our total primary NIW by FICO, loan-to-value (LTV) ratio, and purchase/refinance mix for the periods indicated.

Primary NIW by FICO For the three months ended  
  March 31, 2021   December 31, 2020   March 31, 2020  
   
  ($ In Millions)
>= 760 $ 12,914     $ 11,495     $ 6,290    
740-759 5,312     3,387     1,615    
720-739 3,963     2,447     1,579    
700-719 2,358     1,430     1,038    
680-699 1,360     820     565    
<=679 490     203     210    
Total $ 26,397     $ 19,782     $ 11,297    
Weighted average FICO 755     761       757    

Primary NIW by LTV For the three months ended
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
95.01% and above $ 2,451     $ 1,877     $ 721  
90.01% to 95.00% 11,051     7,839     5,009  
85.01% to 90.00% 7,848     6,239     4,082  
85.00% and below 5,047     3,827     1,485  
Total $ 26,397     $ 19,782     $ 11,297  
Weighted average LTV 91.0 %   90.9 %   91.3 %

Primary NIW by purchase/refinance mix For the three months ended
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
Purchase $ 17,909     $ 13,085     $ 7,991  
Refinance 8,488     6,697     3,306  
Total $ 26,397     $ 19,782     $ 11,297  

The table below presents a summary of our primary IIF and RIF by book year as of March 31, 2021.

Primary IIF and RIF As of March 31, 2021
  IIF   RIF
   
  (In Millions)
March 31, 2021 $ 26,296     $ 6,508  
2020 53,650     13,397  
2019 20,402     5,342  
2018 8,074     2,057  
2017 6,700     1,678  
2016 and before 8,655     2,224  
Total $ 123,777     $ 31,206  

The tables below present our total primary IIF and RIF by FICO and LTV and total primary RIF by loan type as of the dates indicated.

Primary IIF by FICO As of
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
>= 760 $ 63,919     $ 58,368     $ 47,340  
740-759 20,537     17,442     16,060  
720-739 17,167     15,091     14,002  
700-719 11,536     10,442     10,518  
680-699 7,329     6,777     6,879  
<=679 3,289     3,132     3,695  
Total $ 123,777     $ 111,252     $ 98,494  

Primary RIF by FICO As of
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
>= 760 $ 15,920     $ 14,634     $ 12,076  
740-759 5,214     4,449     4,121  
720-739 4,378     3,868     3,626  
700-719 2,981     2,692     2,696  
680-699 1,896     1,748     1,760  
<=679 817     773     913  
Total $ 31,206     $ 28,164     $ 25,192  

Primary IIF by LTV As of
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
95.01% and above $ 10,616     $ 9,129     $ 8,838  
90.01% to 95.00% 54,832     49,898     46,318  
85.01% to 90.00% 40,057     36,972     31,729  
85.00% and below 18,272     15,253     11,609  
Total $ 123,777     $ 111,252     $ 98,494  

Primary RIF by LTV As of
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
95.01% and above $ 3,106     $ 2,637     $ 2,478  
90.01% to 95.00% 16,139     14,673     13,587  
85.01% to 90.00% 9,818     9,067     7,767  
85.00% and below 2,143     1,787     1,360  
Total $ 31,206     $ 28,164     $ 25,192  

Primary RIF by Loan Type As of
  March 31, 2021   December 31, 2020   March 31, 2020
           
Fixed 99 %   99 %   98 %
Adjustable rate mortgages          
Less than five years          
Five years and longer 1     1     2  
Total 100 %   100 %   100 %

The table below presents a summary of the change in total primary IIF during the periods indicated.

Primary IIF For the three months ended
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Millions)
IIF, beginning of period $ 111,252       $ 104,494       $ 94,754    
NIW 26,397       19,782       11,297    
Cancellations, principal repayments and other reductions (13,872 )     (13,024 )     (7,557 )  
IIF, end of period $ 123,777       $ 111,252       $ 98,494    



Geographic Dispersion

The following table shows the distribution by state of our primary RIF as of the periods indicated.

Top 10 primary RIF by state As of
  March 31, 2021   December 31, 2020   March 31, 2020
California 10.8 %   11.2 %   11.5 %
Texas 9.5     8.8     8.2  
Florida 7.9     7.3     5.9  
Virginia 5.0     5.1     5.3  
Colorado 4.1     4.1     3.6  
Maryland 3.8     3.7     3.4  
Illinois 3.7     3.8     3.8  
Washington 3.5     3.5     3.3  
Georgia 3.3     3.2     2.7  
Pennsylvania 3.3     3.4     3.7  
Total 54.9 %   54.1 %   51.4 %

The table below presents selected primary portfolio statistics, by book year, as of March 31, 2021.

  As of March 31, 2021
Book year Original
Insurance Written
  Remaining
Insurance in
Force
  %
Remaining
of Original Insurance
  Policies
Ever in
Force
  Number of
Policies in
Force
  Number
of Loans
in Default
  # of
Claims
Paid
  Incurred
Loss Ratio
(Inception
to Date)


(1)
  Cumulative
Default Rate


(2)
  Current
default rate


(3)
  ($ Values in Millions)    
2013 $ 162     $ 10     6 %   655     66     2     1     0.4 %   0.5 %   3.0 %
2014 3,451     414     12 %   14,786     2,452     114     48     4.2 %   1.1 %   4.6 %
2015 12,422     2,529     20 %   52,548     13,334     541     113     3.2 %   1.2 %   4.1 %
2016 21,187     5,702     27 %   83,626     27,332     1,256     122     2.8 %   1.6 %   4.6 %
2017 21,582     6,700     31 %   85,897     32,499     1,972     84     4.4 %   2.4 %   6.1 %
2018 27,295     8,074     30 %   104,043     38,090     2,679     64     8.5 %   2.6 %   7.0 %
2019 45,141     20,402     45 %   148,423     77,278     3,276     9     14.1 %   2.2 %   4.2 %
2020 62,702     53,650     86 %   186,174     163,626     1,247         8.3 %   0.7 %   0.8 %
2021 26,397     26,296     100 %   82,232     81,975     3         %   %   %
Total $ 220,339     $ 123,777         758,384     436,652     11,090     441              

(1)   Calculated as total claims incurred (paid and reserved) divided by cumulative premiums earned, net of reinsurance.
(2)   Calculated as the sum of the number of claims paid ever to date and number of loans in default divided by policies ever in force.
(3)   Calculated as the number of loans in default divided by number of policies in force.

The following table provides a reconciliation of the beginning and ending reserve balances for primary insurance claims and claim expenses:

  For the three months ended
  March 31, 2021   March 31, 2020
   
  (In Thousands)
Beginning balance $ 90,567     $ 23,752  
Less reinsurance recoverables (1) (17,608 )   (4,939 )
Beginning balance, net of reinsurance recoverables 72,959     18,813  
       
Add claims incurred:      
Claims and claim expenses incurred:      
Current year (2) 10,557     7,558  
Prior years (3) (5,595 )   (1,861 )
Total claims and claim expenses incurred 4,962     5,697  
       
Less claims paid:      
Claims and claim expenses paid:      
Current year (2) 12      
Prior years (3) 492     1,224  
Total claims and claim expenses paid 504     1,224  
       
Reserve at end of period, net of reinsurance recoverables 77,417     23,286  
Add reinsurance recoverables (1) 18,686     6,193  
Ending balance $ 96,103     $ 29,479  

(1) Related to ceded losses recoverable under the QSR Transactions.
(2) Related to insured loans with their most recent defaults occurring in the current year. For example, if a loan had defaulted in a prior year and subsequently cured and later re-defaulted in the current year, the default would be included in the current year. Amounts are presented net of reinsurance and included $5.3 million attributed to net case reserves and $5.3 million attributed to net IBNR reserves for the three months ended March 31, 2021 and $6.0 million attributed to net case reserves and $1.6 million attributed to net IBNR reserves for the three months ended March 31, 2020.
(3) Related to insured loans with defaults occurring in prior years, which have been continuously in default before the start of the current year. Amounts are presented net of reinsurance and included $0.6 million attributed to net case reserves and $5.0 million attributed to net IBNR reserves for the three months ended March 31, 2021 and $0.6 million attributed to net case reserves and $1.3 million attributed to net IBNR reserves for the three months ended March 31, 2020.

The following table provides a reconciliation of the beginning and ending count of loans in default for the periods indicated.

  For the three months ended
  March 31, 2021   March 31, 2020
Beginning default inventory 12,209     1,448  
Plus: new defaults 1,767     512  
Less: cures (2,868 )   (475 )
Less: claims paid (16 )   (34 )
Less: claims denied (2 )   (2 )
Ending default inventory 11,090     1,449  

The following table provides details of our claims paid, before giving effect to claims ceded under the QSR Transactions, for the periods indicated.

  For the three months ended
  March 31, 2021   March 31, 2020
   
  (In Thousands)
Number of claims paid (1) 16     34  
Total amount paid for claims $ 606     $ 1,503  
Average amount paid per claim $ 38     $ 44  
Severity(2) 61 %   83 %

(1) Count includes one claim settled without payment for the three months ended March 31, 2021 and 2020.
(2) Severity represents the total amount of claims paid including claim expenses divided by the related RIF on the loan at the time the claim is perfected, and is calculated including claims settled without payment.

The following table shows our average reserve per default, before giving effect to reserves ceded under the QSR Transactions, as of the periods indicated.

Average reserve per default: As of March 31, 2021   As of March 31, 2020
   
  (In Thousands)
Case (1) $ 7.9     $ 18.6  
IBNR (1)(2) 0.8     1.7  
Total $ 8.7     $ 21.3  

(1)   Defined as the gross reserve per insured loan in default.
(2)   Amount includes claims adjustment expenses.

The following table provides a comparison of the PMIERs financial requirements as reported by NMIC as of the dates indicated.

  As of
  March 31, 2021   December 31, 2020   March 31, 2020
   
  (In Thousands)
Available Assets $ 1,809,589     $ 1,750,668     $ 1,069,695  
Risk-Based Required Assets 1,261,015     984,372     912,321  

 



ESPERION Reports First Quarter 2021 Financial Results and Provides Company Update

– U.S. Product Revenue of $6.4 Million, Growing Demand Offset by Lower Net Price –

– Prescriptions Grew 46% Sequentially; More Than 35,000 Patients now on NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets –

– Secured Major Medicare Part D Contract Covering Approximately 8.5 Million Lives –

– Strengthened Balance Sheet with $80 Million from Expanded Daiichi Sankyo Agreement and Exercise of Third Tranche of the Oberland Capital Funding Agreement –

ANN ARBOR, Mich., May 04, 2021 (GLOBE NEWSWIRE) — ESPERION (NASDAQ:ESPR), the lipid management company, today reported financial results for the first quarter ended March 31, 2021 and provided a business update.

“In the first quarter our team was focused on driving new prescription growth and executing on strategic initiatives that will enhance our ability to bring our medicines to as many patients as possible. This includes improving Medicare Part D coverage and positioning for NEXLETOL® and NEXLIZET®, as well as building our scientific, health economics and outcomes research platform, all while ensuring our landmark CLEAR cardiovascular outcomes trial remains on track for the second half of 2022,” said Tim M. Mayleben, president and chief executive officer of ESPERION. “The first quarter was a challenging period, but we are encouraged by both our refined product positioning and data indicating that patients are returning to their physician offices, which together are expected to translate into accelerated prescription growth in the second half of the year. Our momentum has continued in the early days of the second quarter as we expanded key agreements with Daiichi Sankyo and Oberland Capital, adding $80 million in cash to the balance sheet while deepening our relationships with these committed and collaborative partners.”

2021 Key Accomplishments and Recent Highlights

  • Secured multi-year Medicare Part D agreement with one of the largest payers in the U.S. to place NEXLETOL® and NEXLIZET® on formulary, effective May 1, 2021
  • Daiichi Sankyo off to a strong start in Germany with 14,000 patients now taking NILEMDO® and NUSTENDI® at the end of first quarter 2021
  • Expanded commercialization agreement with partner Daiichi Sankyo to additional countries across Asia, Middle East and Latin America with a $30 million upfront and up to $175 million in future milestones
  • Exercised the third and final tranche of the Oberland Capital RIPA Agreement, bolstering the balance sheet with $50 million
  • Otsuka dosed first patient in Japanese Phase II clinical trial of bempedoic acid

First Quarter 2021 Financial Results

Total revenue for the first quarter ended March 31, 2021 was $8.0 million compared to $1.8 million for the first quarter of 2020. U.S. product revenue for the first quarter ended March 31, 2021 was $6.4 million, compared to $0.9 million for the comparable period in 2020. Royalty revenue for the first quarter ended March 31, 2021 was $0.6 million. The increase in total revenue was primarily due to NEXLETOL and NEXLIZET being available for sale during the entire first quarter of 2021. NEXLETOL and NEXLIZET became commercially available in the U.S. on March 30, 2020 and June 4, 2020, respectively.

Research and development expenses were $28.0 million for the first quarter of 2021, compared to $34.7 million for the comparable period in 2020. The decrease in expense during the first quarter was primarily attributable to a decline in manufacturing costs which were previously classified as research and development expense prior to FDA approval of NEXLETOL and NEXLIZET in the first quarter of 2020.

Selling, general and administrative expenses were $61.1 million for the first quarter of 2021, compared to $41.6 million for the comparable period in 2020. The increase in expense was primarily attributable to salaries and benefits from the build out of our customer-facing team and other costs to support the commercialization of NEXLETOL and NEXLIZET in the U.S, as well as a $13.3 million one-time charge associated with a legal settlement.

ESPERION had a net loss of $90.9 million for the first quarter of 2021, compared to a net loss of $78.2 million for the comparable period in 2020. ESPERION had a basic and diluted net loss per share of $3.50 for the first quarter of 2021, compared to $2.84 for the comparable period in 2020.

As of March 31, 2021, cash, cash equivalents and investment securities available-for-sale totaled $217.9 million compared with $305.0 million at December 31, 2020. This amount does not include the $30 million upfront payment resulting from the expanded Daiichi Sankyo collaboration partnership or the $50 million third and final tranche from Oberland Capital.

ESPERION ended the quarter with approximately 26.2 million shares of common stock outstanding, excluding the 2.0 million treasury shares to be purchased in the prepaid forward transaction as part of the convertible debt financing with another 4.7 million issuable upon exercise of stock options and vesting of restricted stock units.

2021 Financial Outlook

Esperion’s pro-forma cash balance as of March 31, 2021 was $297.9 million as a result of the $30 million upfront payment from Daiichi Sankyo and the $50 million payment from Oberland Capital to be received in May 2021.

Research and development expenses for the full year 2021 are expected to be $120 million to $130 million. Selling, general and administrative expenses for the full year 2021 are expected to be $200 million to $210 million.

ESPERION continues to expect full-year 2021 operating expenses to be approximately $320 million to $340 million, inclusive of $30 million of non-cash, stock-based compensation.

Conference Call and Webcast Information

ESPERION will host a conference call and webcast today, May 4, 2021 at 4:30 P.M. Eastern Time to provide a first quarter 2021 financial results and company update. The call can be accessed by dialing (877) 831-3840 (domestic) or (253) 237-1184 (international) five minutes prior to the start of the call and providing the access code 6373518.

A live audio webcast can be accessed on the investors and media section of the ESPERION website at investor.esperion.com. Access to the webcast replay will be available approximately two hours after completion of the call and will be archived on the ESPERION website for approximately 90 days.

CLEAR Cardiovascular Outcomes Trial

The effect of bempedoic acid on cardiovascular morbidity and mortality has not been determined. ESPERION initiated a global cardiovascular outcomes trial (CVOT) to assess the effects of bempedoic acid on the occurrence of major cardiovascular events in patients with, or at high risk for, cardiovascular disease (CVD) who are only able to tolerate less than the lowest approved daily starting dose of a statin and are considered “statin averse.” The CVOT — known as CLEAR Cardiovascular Outcomes Trial — is an event-driven, global, randomized, double-blind, placebo-controlled study that completed enrollment in August 2019 of over 14,000 patients with hypercholesterolemia and high CVD risk at over 1,200 sites in 32 countries.

ESPERION Therapeutics

ESPERION is The Lipid Management Company. Our goal is lipid management for everybody, that’s why we work hard to make our medicines easy to get, easy to take and easy to have. We discover, develop and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren’t being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. We are singularly focused on managing cholesterol so you can improve your health easily. For more information, please visit www.esperion.com and follow us on Twitter at www.twitter.com/EsperionInc.

ESPERION Therapeutics’ Commitment to Patients with Hyperlipidemia

High levels of LDL-C can lead to a build-up of fat and cholesterol in and on artery walls (known as atherosclerosis), potentially leading to cardiovascular events, including heart attack and stroke. In the U.S., 96 million people, or more than 37 percent of the adult population, have elevated LDL-C. There are approximately 18 million people in the U.S. living with elevated levels of LDL-C despite taking maximally tolerated lipid-modifying therapy — including individuals considered statin averse — leaving them at high risk for cardiovascular events1. In the United States, more than 50 percent of atherosclerotic cardiovascular disease (ASCVD) patients and heterozygous familial hypercholesterolemia (HeFH) patients who are not able to reach their guideline recommended LDL-C levels with statins alone need less than a 40 percent reduction to reach their LDL-C threshold goal2.

ESPERION’s mission as the Lipid Management Company is to deliver oral, once-daily medicines that complement existing oral drugs to provide the additional LDL-C lowering that these patients need.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the global clinical development and commercialization plans for bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet, including ESPERION’s timing, designs, plans for announcement of results regarding its CLEAR Outcomes study and other ongoing clinical studies for bempedoic acid tablet and the bempedoic acid / ezetimibe combination fixed dose tablet, timing for the review and approval of expanded indications for their effect on cardiovascular events, ESPERION’s expectations for the market for medicines to lower LDL-C, including the prospects for success of the commercial launch and market adoption of bempedoic acid tablet and the bempedoic acid / ezetimibe fixed dose combination tablet in the United States and European Union, the development of ESPERION’s in-licensed pre-clinical oral PCSK9 inhibitor program, and ESPERION’s financial outlook, including expectations for future revenues from its product sales, partnership collaborations and other sources. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause ESPERION’s actual results to differ significantly from those projected, including, without limitation, delays or failures in ESPERION’s clinical development and the commercialization plans of both ESPERION and Daiichi Sankyo group, failure to obtain the approval of bempedoic acid or the bempedoic acid / ezetimibe combination tablet or expanded indications in countries outside of the U.S., or approval of expanded indications, that existing cash resources may be used more quickly than anticipated, that Otsuka and Daiichi Sankyo are able to successfully commercialize its products, the impact of COVID-19 on our business, clinical activities, supply chain, commercial development and launch plans, and the risks detailed in ESPERION’s filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and ESPERION disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

References

(1) ESPERION market research on file: research project interviewing 350 physicians. ESPERION Therapeutics, Inc. Sept-Oct 2018.
(2) Data on file: analysis of NHANES database. ESPERION Therapeutics, Inc. 2018.

ESPERION Therapeutics, Inc.

Balance Sheet Data

(In thousands)

(Unaudited)

  March 31,

2021
  December 31,

2020
Cash and cash equivalents $ 217,939     $ 304,962   
Working capital 174,682     251,827   
Total assets 278,606     353,258   
Revenue interest liability 180,956     176,604   
Convertible notes, net of issuance costs 271,694     179,367  
Common stock 26     26   
Accumulated deficit (928,204 )   (838,817 )
Total stockholders’ deficit (269,394 )   (96,134  )





ESPERION Therapeutics, Inc.

Statement of Operations

(In thousands, except share and per share data)

(Unaudited)

Three Months Ended

March 31,
  2021     2020
Revenues:  
Product sales, net $ 6,350     $ 858  
Collaboration revenue   1,628       982  
Total Revenues   7,978       1,840  
     
Operating expenses:      
Cost of goods sold   1,784       31  
Research and development   27,954       34,702  
Selling, general and administrative   61,064       41,553  
Total operating expenses   90,802       76,286  
     
Loss from operations   (82,824 )     (74,446 )
     
Interest expense   (8,125 )     (4,171 )
Other income, net   14       368  
Net loss $ (90,935 )   $ (78,249 )
     
Net loss per common share – basic and diluted $ (3.50 )   $ (2.84 )
     
Weighted-average shares outstanding – basic and diluted   25,991,817       27,519,229  

Contact:
Kaitlyn Brosco
ESPERION
[email protected]



Pulmonx Corporation Expands Leadership Team

REDWOOD CITY, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”) a global leader in minimally invasive treatments for severe lung disease, today announced the appointment of Michael Ryan as Vice President, Corporate Strategy and Business Development, and the earlier appointments of David Lehman as General Counsel, and Mahtab Fatemi as Vice President, Regulatory Affairs and Quality Assurance.

“We could not be more excited to have these three deeply experienced professionals on the Pulmonx team. Each of these individuals is uniquely qualified and brings a wealth of insight and knowledge about the medical device business to their respective areas of responsibility,” said Glen French, President and CEO of Pulmonx. 

Mr. Ryan, who will lead all corporate strategy and business development initiatives for the company, joins Pulmonx from Boston Scientific Corporation (BSC) where he was Vice President, Business Development. At BSC, Mr. Ryan led a team directing all business development and investment efforts across five of BSC’s seven business units.  He has been deeply involved in BSC’s interests in the pulmonary space for more than a decade, including leading its prior investments in Pulmonx, and was an Observer on the Pulmonx Board of Directors for more than five years. Mr. Ryan holds a B.A. in Biological Sciences from Cornell University.

Mr. Lehman oversees all aspects of the company’s legal activities and joined Pulmonx after General Counsel roles at Intersect ENT and before that Thoratec Corporation. Mr. Lehman has been General Counsel and Secretary of public medical device companies for nearly 20 years; during which time he has provided legal counsel to management teams and boards of directors on a wide range of legal, strategic and compliance matters. Mr. Lehman holds a J.D. from Cornell Law School, and a B.A. in Political Science from University of California at San Diego, Muir College.

Ms. Fatemi leads all aspects of Regulatory Affairs and Quality Assurance (RA/QA) at Pulmonx. She is a Food and Drug Attorney with more than 20 years’ experience in the medical device and pharmaceutical industries. Ms. Fatemi joined Pulmonx from Nuvaira, which is developing a novel technology for the treatment of COPD, where she was VP, RA/QA for more than seven years. Before Nuvaira, she was an RA/QA consultant for more than six years during which she worked with Broncus Technologies on its pulmonary diagnostic and therapeutic devices. Ms. Fatemi holds a J.D. from Santa Clara University, a M.S. in Physiology from Georgetown University, and a B.S. in Biology from the University of California at Irvine.

About Pulmonx

Pulmonx Corporation (Nasdaq: LUNG) is a global leader in minimally invasive treatments for severe lung disease. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who despite medical management are still profoundly symptomatic. Pulmonx received FDA pre-market approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, with over 80,000 valves used to treat more than 20,000 patients. For more information on the Zephyr Valves, please visit www.MyLungsMyLife.com. For more information on the company, please visit www.Pulmonx.com.

Media Contact:

Meghan Oreste
Director of Marketing Communications
Pulmonx
[email protected]
617-823-1441

Investor Relations Contact

Brian Johnston
Gilmartin Group
[email protected]



Big 5 Sporting Goods Corporation Announces Fiscal 2021 First Quarter Results

  • Achieves Record First Quarter Sales and Earnings Results
  • Same Store Sales Increased 31.8% in FY 2021 First Quarter versus Guidance of 20%
  • EPS of $0.96 for FY 2021 First Quarter versus Guidance Range of $0.47 to $0.53
  • Ends FY 2021 First Quarter with $100.1 Million in Cash and Cash Equivalents, No Debt
  • Increases Quarterly Cash Dividend by 20% to $0.18 per Share
  • Declares Special Cash Dividend of $1.00 per Share

EL SEGUNDO, Calif., May 04, 2021 (GLOBE NEWSWIRE) — Big 5 Sporting Goods Corporation (Nasdaq: BGFV) (the “Company,” “we,” “our,” “us,” “Big 5”), a leading sporting goods retailer, today reported financial results for the fiscal 2021 first quarter ended April 4, 2021.

Steven G. Miller, the Company’s Chairman, President and Chief Executive Officer, said, “We are pleased to report record first quarter results driven by a combination of top line sales strength, merchandise margin expansion and an improved cost structure. Our team continues to do a tremendous job satisfying the incredible consumer demand we are seeing across our diverse product mix.”

Mr. Miller continued, “Same store sales were up 31.8% for the fiscal 2021 first quarter reflecting broad-based strength across apparel, footwear and hardgoods, including very robust demand for winter-related products. These results were especially remarkable given the headwinds impacting sales of team sports products due to the widespread suspension of league play over most of the quarter. Our sales accelerated beyond expectations in March, benefitting from the resumption of team sports activities, along with school re-openings and stimulus checks. Our strong sales momentum has continued into the second quarter with sales performing at historically high levels for the quarter to date. We are excited by the strength in our business, which has translated to our balance sheet, as we continue to operate with zero debt while growing our cash position.   In light of this strength and to continue to return value to shareholders, our Board of Directors has declared a 20% increase in our regular cash dividend to an annual rate of $0.72 per share and also has declared a special cash dividend of $1.00 per share.”

Net sales for the fiscal 2021 first quarter were $272.8 million compared to net sales of $217.7 million for the first quarter of fiscal 2020, which included significant store closures due to COVID-19 over the last ten days of the period. Same store sales increased 31.8% for the first quarter of fiscal 2021. The increase in net sales was partially offset by an approximately $10.0 million unfavorable impact from the calendar shift related to the Company’s 53-week fiscal 2020 that caused fiscal 2021 to begin one week later than fiscal 2020, as well as an unfavorable impact from the calendar shift related to the Easter holiday, during which the Company’s stores are closed, from the second quarter in fiscal 2020 to the first quarter in fiscal 2021. Same store sales comparisons are made on a comparable-week basis and the calendar shifts did not have a material impact on same store sales comparisons.

Gross profit for the fiscal 2021 first quarter increased to $97.9 million from $64.6 million in the first quarter of the prior year. The Company’s gross profit margin was 35.9% in the fiscal 2021 first quarter versus 29.6% in the first quarter of the prior year. The increase in gross profit margin largely reflects a 350-basis point increase in merchandise margins, lower store occupancy and warehousing costs as a percentage of net sales and, to a lesser degree, the favorable impact from an insurance settlement, partially offset by lower distribution costs capitalized into inventory for the quarter.

Selling and administrative expense as a percentage of net sales was 25.7% in the fiscal 2021 first quarter versus 32.8% in the fiscal 2020 first quarter. Overall selling and administrative expense for the quarter decreased $1.3 million from the prior year primarily due to lower print advertising expense and the elimination of a liability for an employment agreement, partially offset by higher performance-based incentive compensation accruals.

Net income for the first quarter of fiscal 2021 was $21.5 million, or $0.96 per diluted share, which includes a benefit of $0.06 per diluted share related to the elimination of the employment agreement liability and the insurance settlement.   Net loss for the first quarter of fiscal 2020 was $4.6 million, or $0.22 per basic share.

Adjusted EBITDA for the first quarter of fiscal 2021 was $30.3 million, compared to a loss of $2.2 million in the prior year period. EBITDA and Adjusted EBITDA are non-GAAP financial measures. See “Non-GAAP Financial Measures” below for more details and a reconciliation of non-GAAP Adjusted EBITDA and EBITDA to the most comparable GAAP measure, net income.

Balance Sheet

The Company ended the fiscal 2021 first quarter with no borrowings under its credit facility and with cash and cash equivalents of $100.1 million. This compares to zero borrowings and $64.7 million of cash and cash equivalents as of the end of the 2020 fiscal year and to $124.3 million of borrowings and $44.2 million of cash as of the end of the fiscal 2020 first quarter, reflecting a $180.2 million improvement in net cash (cash less revolver borrowings) on a year-over-year basis and a $35.4 million improvement in net cash compared to the end of fiscal 2020. Total merchandise inventories decreased by approximately 20.8% as of the end of the fiscal 2021 first quarter versus the first quarter of the prior year.

Quarterly Cash Dividend and Special Cash Dividend

In light of the continued strength of the Company’s business, cash flow generation and improved balance sheet, the Company’s Board of Directors has declared a 20% increase in its quarterly cash dividend from $0.15 per share of outstanding common stock to $0.18 per share of outstanding common stock, which will be paid on June 15, 2021 to stockholders of record as of June 1, 2021. Additionally, to further return value to shareholders, the Company’s Board of Directors has declared a special cash dividend of $1.00 per share of outstanding common stock, which will be paid on June 1, 2021 to stockholders of record as of May 17, 2021.

Second Quarter Guidance
For the fiscal 2021 second quarter, the Company expects same store sales to increase in the range of 22% to 27% and expects to realize earnings per diluted share in the range of $1.05 to $1.25. Fiscal 2021 second quarter guidance reflects the combined positive impact of calendar shifts of the Easter holiday, during which the Company’s stores are closed, from the second quarter of fiscal 2020 into the first quarter of fiscal 2021, and the Fourth of July holiday from the third quarter of fiscal 2020 into the second quarter of fiscal 2021. The Company’s second quarter guidance compares to a same store sales decrease of 4.2% and earnings per diluted share of $0.52 in the second quarter of fiscal 2020, which included a net benefit of approximately $0.13 per diluted share related to rent abatement savings and a recovery in eminent domain litigation, partially offset by expense associated with special employee recognition bonus awards.  

Store Openings

The Company currently has 430 stores in operation. During fiscal 2021, the Company expects to open approximately five stores and close approximately two stores.

Conference Call Information

The Company will host a conference call and audio webcast today, May 4, 2021, at 2:00 p.m. Pacific (5:00 p.m. Eastern), to discuss financial results for the first quarter of fiscal 2021. To access the conference call, participants in North America may dial (877) 407-9039 and international participants may dial (201) 689-8470. Participants are encouraged to dial in to the conference call ten minutes prior to the scheduled start time. The call will also be broadcast live over the Internet and accessible through the Investor Relations section of the Company’s website at www.big5sportinggoods.com. Visitors to the website should select the “Investor Relations” link to access the webcast. The webcast will be archived and accessible on the same website for 30 days following the call. A telephonic replay will be available through May 11, 2021 by calling (844) 512-2921 to access the playback; the passcode is 13719234.

About Big 5 Sporting Goods Corporation 
Big 5 is a leading sporting goods retailer in the western United States, operating 430 stores under the “Big 5 Sporting Goods” name as of the fiscal quarter ended April 4, 2021. Big 5 provides a full-line product offering in a traditional sporting goods store format that averages 11,000 square feet. Big 5’s product mix includes athletic shoes, apparel and accessories, as well as a broad selection of outdoor and athletic equipment for team sports, fitness, camping, hunting, fishing, home recreation, tennis, golf, and winter and summer recreation.

Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause Big 5’s actual results in current or future periods to differ materially from forecasted results. These risks and uncertainties include, among other things, the economic impacts of COVID-19 on Big 5’s business operations, including as a result of regulations that may be issued in response to COVID-19, changes in the consumer spending environment, fluctuations in consumer holiday spending patterns, increased competition from e-commerce retailers, breach of data security or other unauthorized disclosure of sensitive personal or confidential information, the competitive environment in the sporting goods industry in general and in Big 5’s specific market areas, inflation, product availability and growth opportunities, changes in the current market for (or regulation of) firearm-related products, a reduction or loss of product from a key supplier, disruption in product flow, seasonal fluctuations, weather conditions, changes in cost of goods, operating expense fluctuations, increases in labor and benefit-related expense, changes in laws or regulations, including those related to tariffs and duties, public health issues (including those caused by COVID-19), impacts from civil unrest or widespread vandalism, lower than expected profitability of Big 5’s e-commerce platform or cannibalization of sales from Big 5’s existing store base which could occur as a result of operating the e-commerce platform, litigation risks, stockholder campaigns and proxy contests, risks related to Big 5’s historically leveraged financial condition, changes in interest rates, credit availability, higher expense associated with sources of credit resulting from uncertainty in financial markets and economic conditions in general. Those and other risks and uncertainties are more fully described in Big 5’s filings with the Securities and Exchange Commission, including its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Big 5 conducts its business in a highly competitive and rapidly changing environment. Accordingly, new risk factors may arise. It is not possible for management to predict all such risk factors, nor to assess the impact of all such risk factors on Big 5’s business or the extent to which any individual risk factor, or combination of factors, may cause results to differ materially from those contained in any forward-looking statement. Big 5 undertakes no obligation to revise or update any forward-looking statement that may be made from time to time by it or on its behalf.

Non-GAAP Financial Measures 
In addition to reporting our financial results in accordance with generally accepted accounting principles (“GAAP”), we are providing non-GAAP adjusted earnings before interest, income tax expense, depreciation and amortization (“EBITDA”) and other adjustments (“Adjusted EBITDA”). EBITDA and Adjusted EBITDA are not prepared in accordance with GAAP and exclude certain items presented below. We use EBITDA and Adjusted EBITDA internally for forecasting purposes and as factors to evaluate our operating performance. We believe that Adjusted EBITDA provides useful information to both management and investors by excluding certain expenses, gains and losses that may not be indicative of core operating results and business outlook. While we believe that EBITDA and Adjusted EBITDA can be useful to investors in evaluating our period-to-period operating results, this information should be considered supplemental and is not a substitute for financial information prepared in accordance with GAAP. In addition, our definition or calculation of these non-GAAP measures may differ from similarly titled measures used by other companies, limiting the usefulness of this financial measure for comparison to other companies. We believe the GAAP measure that is most comparable to non-GAAP EBITDA and Adjusted EBITDA is net income, and a reconciliation of our non-GAAP EBITDA and Adjusted EBITDA to GAAP net income is provided below.

    13 Weeks Ended
    April 4,

2021
    March 29,

2020
     
    (In thousands)
GAAP net income (loss) (as reported)   $ 21,546       $ (4,611 )
+ Interest (as reported)     342         735  
+ Income tax expense (benefit) (as reported)     5,861         (2,939 )
+ Depreciation and amortization (as reported)     4,259         4,606  
EBITDA   $ 32,008       $ (2,209 )
– Elimination of liability for an employment agreement     (995 )        
– Gain on recovery of insurance settlement related to civil unrest     (709 )        
Adjusted EBITDA   $ 30,304       $ (2,209 )
                   

FINANCIAL TABLES FOLLOW

BIG 5 SPORTING GOODS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share amounts)
         
         
    April 4,

2021
  January 3,

2021
 
ASSETS
         
Current assets:        
Cash and cash equivalents $ 100,097   $ 64,654  
Accounts receivable, net of allowances of $80 and $58, respectively   11,399     19,879  
Merchandise inventories, net   247,287     251,180  
Prepaid expenses   10,513     11,684  
Total current assets   369,296     347,397  
         
Operating lease right-of-use assets, net   271,964     278,607  
Property and equipment, net   58,710     57,245  
Deferred income taxes   12,532     13,831  
Other assets, net of accumulated amortization of $594 and $2,407, respectively   3,610     2,914  
Total assets $ 716,112   $ 699,994  
         
LIABILITIES AND STOCKHOLDERS’ EQUITY
         
Current liabilities:        
Accounts payable $ 88,613   $ 80,882  
Accrued expenses   78,351     82,877  
Current portion of operating lease liabilities   73,196     73,737  
Current portion of finance lease liabilities   2,664     2,089  
Total current liabilities   242,824     239,585  
         
Operating lease liabilities, less current portion   210,891     217,788  
Finance lease liabilities, less current portion   4,332     2,504  
Other long-term liabilities   6,865     7,479  
Total liabilities   464,912     467,356  
         
Commitments and contingencies        
         
Stockholders’ equity:        
Common stock, $0.01 par value, authorized 50,000,000 shares; issued 25,938,473 and        
25,580,541 shares, respectively; outstanding 22,288,260 and 21,930,328 shares, respectively   259     255  
Additional paid-in capital   122,188     121,837  
Retained earnings   171,280     153,073  
Less: Treasury stock, at cost; 3,650,213 shares   (42,527 )   (42,527 )
Total stockholders’ equity   251,200     232,638  
Total liabilities and stockholders’ equity $ 716,112   $ 699,994  
         

BIG 5 SPORTING GOODS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
         
         
    13 Weeks Ended
    April 4,

2021
  March 29,

2020
         
         
Net sales $ 272,806 $ 217,736  
         
Cost of sales   174,913   153,181  
         
Gross profit   97,893   64,555  
         
Selling and administrative expense   70,144   71,370  
         
Operating income (loss)   27,749   (6,815 )
         
Interest expense   342   735  
         
Income (loss) before taxes   27,407   (7,550 )
         
Income tax expense (benefit)   5,861   (2,939 )
         
Net income (loss) $ 21,546 $ (4,611 )
         
Earnings (loss) per share:        
Basic $ 1.01 $ (0.22 )
Diluted $ 0.96 $ (0.22 )
         
Weighted-average shares of common stock outstanding:        
Basic   21,417   21,149  
Diluted   22,371   21,149  
         

Contact:

Big 5 Sporting Goods Corporation
Barry Emerson
Executive Vice President and Chief Financial Officer
(310) 536-0611

ICR, Inc.
John Mills
Managing Partner
(646) 277-1254