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Leidos, Inc. Announces Pricing Terms of Cash Tender Offer for Any and All 2.950% Senior Notes Due 2023

On February 23, 2023 Leidos Holdings, Inc. (NYSE: LDOS) ("Holdings"), a FORTUNE 500 science and technology leader, reported the pricing terms of the previously announced offer by its wholly-owned subsidiary, Leidos, Inc. ("Leidos") to purchase for cash (the "Tender Offer") any and all of its outstanding 2.950% Senior Notes due 2023 (the "2023 Notes") (Press release, Leidos, FEB 23, 2023, View Source [SID1234627645]). The Tender Offer is being made pursuant to the terms and subject to the conditions set forth in the Offer to Purchase, dated as of February 16, 2023 (the "Offer to Purchase") and the related notice of guaranteed delivery (together with the Offer to Purchase, the "Offer Documents"). Holders of the 2023 Notes ("Holders") are urged to read the Offer Documents carefully before making any decision with respect to the Tender Offer.

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The consideration (the "Tender Offer Consideration") for each $1,000 principal amount of the 2023 Notes validly tendered, and not validly withdrawn, and accepted for purchase pursuant to the Tender Offer was determined in the manner described in the Offer to Purchase by reference to the fixed spread for the 2023 Notes specified below plus the yield based on the bid-side price of the U.S. Treasury Reference Security specified below as of 2:00 p.m., New York City time today, the date on which the Tender Offer is currently scheduled to expire.

Title of
Security

CUSIP number / ISIN

Principal
Amount
Outstanding

U.S.
Treasury
Reference
Security

Bloomberg
Reference
Page

Reference
Yield

Fixed
Spread

Tender Offer
Consideration

2.950%
Senior
Notes
due 2023

52532XAB1 /
US52532XAB10

$500,000,000

1.750%
U.S.
Treasury
due May
15, 2023

FIT3

4.906 %

0 bps

$995.77

In addition to the Tender Offer Consideration, Holders will also receive accrued and unpaid interest on the 2023 Notes validly tendered and accepted for purchase from November 15, 2022, the last interest payment date, up to, but not including, the date on which Leidos makes payment for such 2023 Notes, which date is currently expected to be February 28, 2023 (such date, as it may be extended, the "Settlement Date").

The Tender Offer will expire at 5:00 p.m., New York City time, on February 23, 2023, unless extended or earlier terminated as described in the Offer to Purchase (such time and date, as they may be extended, the "Expiration Time"). Holders must validly tender, and not validly withdraw, their 2023 Notes at or prior to the Expiration Time, or pursuant to the guaranteed delivery procedures described in the Offer Documents, to be eligible to receive in cash the Tender Offer Consideration and accrued and unpaid interest as described above.

Holders who validly tender their 2023 Notes may validly withdraw their tendered 2023 Notes at any time prior to the earlier of (i) the Expiration Time and (ii) if the Tender Offer is extended, the 10th business day after commencement of the Tender Offer. 2023 Notes may also be validly withdrawn at any time after the 60th business day after commencement of the Tender Offer if for any reason the Tender Offer has not been consummated by that date.

The Tender Offer is subject to the satisfaction or waiver of certain conditions, including the successful completion by Leidos of an offering (the "Offering") of new senior notes on terms satisfactory to Leidos in its sole discretion, generating net proceeds in an amount that is sufficient to effect (i) the repurchase of the 2023 Notes validly tendered, and not validly withdrawn, and accepted for purchase pursuant to the Tender Offer, and (ii) the repayment, in accordance with the satisfaction and discharge terms of the indenture governing the 2023 Notes, of all 2023 Notes remaining outstanding after the Tender Offer, if applicable, including the payment of any accrued interest and costs and expenses incurred in connection with the foregoing. If any 2023 Notes remain outstanding after the consummation of the Tender Offer, Leidos expects (but is not obligated) to repay such 2023 Notes in accordance with the satisfaction and discharge terms and conditions set forth in the related indenture. The Offering is not conditioned on the completion of the Tender Offer.

BofA Securities, Inc. ("BofA") and Citigroup Global Markets Inc. ("Citigroup") are acting as the dealer managers (the "Dealer Managers") in connection with the Tender Offer, and Global Bondholder Services Corporation ("GBSC") is serving as the depositary agent and information agent for the Tender Offer. Copies of the Offer Documents are available via the Tender Offer website at View Source or by contacting GBSC via telephone at +1 (212) 430-3774 (collect) or +1 (855) 654–2014 (tollfree) or via email at [email protected]. Questions regarding the terms of the Tender Offer should be directed to BofA Securities at +1 (980) 387-3907 (collect) or +1 (888) 292-0070 (toll-free), or to Citigroup at +1 (212) 723-6106 (collect) or +1 (800) 558-3745 (toll-free).

None of Holdings, Leidos, their respective board of directors, the Dealer Managers, GBSC or the trustee for the 2023 Notes, or any of their respective affiliates, is making any recommendation as to whether Holders should tender any 2023 Notes in response to the Tender Offer. Holders must make their own decision as to whether to tender any of their 2023 Notes and, if so, the principal amount of 2023 Notes to tender.

This press release is neither an offer to purchase nor a solicitation of an offer to sell any of the 2023 Notes, or an offer to sell or a solicitation of an offer to purchase the new notes pursuant to the Offering nor is it a solicitation for acceptance of the Tender Offer, nor shall it constitute a notice of redemption under the indenture governing the 2023 Notes. Leidos is making the Tender Offer only by, and pursuant to the terms of, the Offer Documents. The Tender Offer is not being made in any jurisdiction in which the making or acceptance thereof would not be in compliance with the securities, blue sky or other laws of such jurisdiction.

Entry into a Material Definitive Agreement

On February 23, 2023 F-star Therapeutics, Inc., a Delaware corporation (the "Company"), invoX Pharma Limited, a private limited company organized under the laws of England and Wales ("Parent") and Fennec Acquisition Incorporated, a Delaware corporation and a wholly owned subsidiary of Parent ("Purchaser" and together with the Company and Parent, the "Parties"), reported that it has entered into Amendment No. 7 ("Amendment No. 7") to the Agreement and Plan of Merger, dated as of June 22, 2022, and as amended, by and among the Parties and Sino Biopharmaceutical Limited, a company organized under the laws of the Cayman Islands, as "Guarantor" (the "Merger Agreement") (Filing, 8-K, F-star, FEB 23, 2023, View Source [SID1234627644]). Capitalized terms used in this Current Report on Form 8-K without being defined herein shall have the same meanings ascribed to them in the Merger Agreement.

The purpose of Amendment No. 7 is to extend the End Date of the Merger Agreement in order to provide additional time for the Parties to finalize an agreement with the Committee on Foreign Investment in the United States ("CFIUS") and to complete the ongoing tender offer (the "Offer") whose expiration date has been extended to March 3, 2023, unless further extended, as described below.

The Parties believe they are in the late stages of the approval process for a definitive agreement necessary to remove CFIUS’s Interim Order and allow the transaction to close. However, there can be no assurances that the Parties will reach a final agreement with CFIUS.

Other than as expressly modified pursuant to Amendment No. 7, the Merger Agreement, which was previously filed as Exhibit 2.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission (the "SEC") by the Company on June 23, 2022, remains in full force and effect as originally executed on June 22, 2022, as amended. The foregoing description of Amendment No. 7 does not purport to be complete and is subject to, and qualified in its entirety by, the full text of Amendment No. 7 attached hereto as Exhibit 2.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

Exact Sciences Announces Debt Exchange Transaction And Private Placement Of Convertible Senior Notes

On February 23, 2023 Exact Sciences Corp. (Nasdaq: EXAS) (the "Company"), a leading provider of cancer screening and diagnostic tests, reported that on February 23, 2023 it entered into a privately negotiated exchange and purchase agreement (the "Agreement") with a holder of certain of the Company’s 0.3750% Convertible Senior Notes due 2027 (the "Existing 2027 Notes") and certain of its 0.3750% Convertible Senior Notes due 2028 (the "Existing 2028 Notes", and together with the "Existing 2027 Notes", the "Existing Notes") (Press release, Exact Sciences, FEB 23, 2023, View Source [SID1234627643]). Pursuant to the Agreement, the Company has agreed to issue to the holder $500,000,000 aggregate principal amount of a new series of 2.00% Convertible Senior Notes due 2030 (the "2030 Notes") in exchange for (i) $183,678,000 aggregate principal amount of the holder’s Existing 2027 Notes, (ii) $200,958,000 aggregate principal amount of the holder’s Existing 2028 Notes, and (iii) approximately $138,000,000 in cash. The closing of the transaction is expected to occur on March 1, 2023, subject to customary closing conditions.

The 2030 Notes will mature on March 1, 2030 (the "Maturity Date"), unless earlier repurchased or converted. The 2030 Notes will be senior unsecured obligations of the Company and bear interest at a rate of 2.00% per year, payable semi-annually in arrears on March 1 and September 1 of each year, beginning on September 1, 2023.

Prior to September 1, 2029, the 2030 Notes will be convertible only upon the occurrence of certain events and during certain periods, and thereafter, until the close of business on the second scheduled trading day immediately preceding the Maturity Date. The 2030 Notes will be convertible into cash, shares of the Company’s common stock (plus, if applicable, cash in lieu of any fractional share), or a combination of cash and shares of the Company’s common stock, at the Company’s election.

The Company may not redeem the 2030 Notes prior to the Maturity Date. If a "fundamental change" occurs prior to the Maturity Date, subject to certain conditions, holders may require the Company to repurchase for cash all or any portion of their 2030 Notes at a repurchase price equal to 100% of the principal amount of the 2030 Notes to be repurchased plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

The conversion rate for the 2030 Notes is initially 12.3724 shares per $1,000 principal amount of 2030 Notes, which is equivalent to an initial conversion price of approximately $80.825 per share of common stock representing a conversion premium of 25.00% over the last reported sale price of $64.66 per share of the Company’s common stock on the Nasdaq Stock Market on February 22, 2023. The conversion rate is subject to adjustment upon the occurrence of certain specified events but will not be adjusted for accrued and unpaid interest. In addition, the 2030 Notes include a customary provision pursuant to which holders of the 2030 Notes who convert their 2030 Notes in connection with a "make-whole fundamental change", will, under certain circumstances, be entitled to an increase in the conversion rate.

XMS Capital Partners LLC acted as sole placement agent for the transaction.

K&L Gates LLP represented Exact Sciences Corporation and Kramer Levin Naftalis & Frankel LLP represented the placement agent in the transaction.

The offer and sale of the 2030 Notes and any shares of common stock issuable upon conversion of the 2030 Notes have not been registered under the Securities Act of 1933 or any other securities laws, and the 2030 Notes and any such shares cannot be offered or sold except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.

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

Entry into a Material Definitive Agreement

On February 23, 2023 the Company amended and restated those two certain convertible promissory notes between the Company and Paseco ApS (the "Holder") dated February 6, 2020, each in the principal amount of $600,000 (the "February Notes") by entering into two amended and restated secured convertible promissory notes, each with an effective date of December 30, 2022 and each in the principal amount of $600,000 (the "Amended and Restated February Notes") (Filing, 8-K, Enochian BioSciences, FEB 23, 2023, View Source [SID1234627642]). The Amended and Restated February Notes extend the maturity date of the February Notes to February 28, 2024, secure the Company’s obligations under the February Notes pursuant to the Security Agreement (as defined below) and amend certain other terms.

On February 16, 2023, the Company amended that certain promissory note dated March 30, 2020 in the principal amount of $5,000,000 between the Company and the Holder (the "March Note"). The amendment to the March Note, effective December 30, 2022 (the "Amendment to the March Note"), secures the Company’s obligations under the March Note pursuant to the Security Agreement (as defined below).

On February 16, 2023, the Company entered into a security agreement between the Company and the Holder, effective as of December 30, 2022 (the "Security Agreement") under which the Company pledged and granted the Holder a first priority security interest in and lien upon all of the Company’s wholly-owned assets as collateral security for the prompt payment in full of the principal amounts of the February Notes and the March Note when due. The Security Agreement contains customary representations, warranties and covenants of the parties thereto.

The foregoing is a brief description of the material terms of the Amended and Restated February Notes, the Amendment to the March Note and the Security Agreement, each of which is qualified in its entirety by reference to the full text thereof included as Exhibit 10.1, Exhibit 10.2, and Exhibit 10.3, respectively, to this Current Report on Form 8-K and each of which is incorporated herein by reference.

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On February 16, 2023, the Company received a notice (the "Notice") from The Nasdaq Stock Market LLC ("Nasdaq") stating that because the Company has not yet filed its Quarterly Report on Form 10-Q for the period ended December 31, 2022 (the "Form 10-Q"), the Company remains in non-compliance with Nasdaq Listing Rule 5250(c)(1), which requires timely filing of all required periodic financial reports with the Securities and Exchange Commission. As previously disclosed on Form 8-Ks filed with the Securities and Exchange Commission, on October 17, 2022 and November 23, 2022, respectively, the Company received notices from Nasdaq indicating that as a result of not having timely filed its Annual Report on Form 10-K for the period ended June 30, 2022 (the "Form 10-K") and its Quarterly Report on Form 10-Q for the period ended September 30, 2022, the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1).

The Notice has no immediate effect on the listing of the Company’s shares on Nasdaq. However, if the Company fails to timely regain compliance with the Nasdaq Listing Rule, the Company’s common stock will be subject to delisting from Nasdaq. As previously reported on Form 8-K, Nasdaq accepted the Company’s plan to regain compliance with Nasdaq Listing Rule 5250(c)(1) and therefore the Company has 180 calendar days from the due date of the Form 10-K, or April 11, 2023, to regain compliance

Item 7.01 Regulation FD Disclosure.

On February 23, 2023, the Company issued a press release disclosing its receipt of the Notice referenced above. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This information is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section, unless we specifically incorporate it by reference in a document filed under the Securities Act of 1933 or the Securities Exchange Act of 1934. By furnishing this information on this Current Report on Form 8-K, we make no admission as to the materiality of any information in this report that is required to be disclosed solely by reason of Regulation FD.

Dynavax Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Full Year 2023 Financial Guidance

On February 23, 2023 Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, reported financial results for the fourth quarter and the full year ending December 2022 (Press release, Dynavax Technologies, FEB 23, 2023, View Source [SID1234627641]).

"In 2022, our team exceeded our strategic goals, achieving record HEPLISAV-B revenue, advancing our clinical pipeline and delivering orders of CpG 1018 adjuvant for the equivalent of hundreds of millions of COVID-19 vaccine doses," said Ryan Spencer, Chief Executive Officer of Dynavax. "Following a year of successful execution on our strategy, we are excited for 2023 and look forward to continuing our trend of significant and sustainable annual HEPLISAV-B revenue growth and overall advancement of our business focused on protecting patients worldwide from infectious diseases."

2023 FINANCIAL GUIDANCE

Dynavax anticipates full-year 2023 revenue and operating expenses to be in the ranges below:

•
HEPLISAV-B net product revenue between approximately $165 – $185 million
•
Research and development expenses between approximately $55 – $70 million
•
Selling, general and administrative expenses between approximately $135 – $155 million

BUSINESS UPDATES

HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted]

HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S. and EU that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S.

•
HEPLISAV-B vaccine achieved record annual net product revenue of $125.9 million for 2022, compared to $61.9 million for 2021, representing annual growth of 104%.
•
HEPLISAV-B market share in prioritized Integrated Delivery Networks (IDNs) and Clinics increased to approximately 47%, with total market share increasing to approximately 35%, up from approximately 33% and 25%, respectively, at the end of 2021.
•
Dynavax believes it has begun to see a positive impact on HEPLISAV-B revenue from the expanded ACIP recommendation for adult hepatitis B vaccination which has the potential to expand the market to over $800 million by 2027 with HEPLISAV-B well-positioned to achieve a majority market-share.

CpG 1018 Adjuvant Supply for COVID-19 Vaccines

Dynavax has established a global portfolio of CpG 1018 adjuvant commercial supply agreements (CSAs) supporting the development of COVID-19 vaccines across a variety of vaccine platforms.

•
CpG 1018 adjuvant achieved annual net product revenue of $587.7 million for 2022, up 57% compared to $375.2 million for 2021.
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•
Due to the successful execution on the pandemic commercial supply agreements and the resulting volume of partners’ overall stockpile, coupled with unknowns about the trajectory of the COVID-19 pandemic, Dynavax believes it will have minimal to as little as zero CpG 1018 adjuvant net product revenues in 2023.

Clinical Pipeline

Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018 adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use.

Tetanus, diphtheria and pertussis (Tdap) vaccine program:

•
In October, the Company presented adult and adolescent safety data from a Phase 1 clinical trial demonstrating the Tdap vaccine candidate was well tolerated without observed safety concerns. Immunogenicity in adults was consistent with the Company’s expectations and support its plan to continue advancement of this clinical program. These clinical results were presented at ID Week 2022.
•
Data from non-human primate challenge study is anticipated mid-2023.
•
The Company plans to initiate a human challenge study by the end of 2023.

Shingles vaccine program:

•
In January 2023, the Company reported top line results from the Phase 1 clinical trial designed to evaluate an investigational shingles vaccine, utilizing different regimens of CpG 1018 adjuvant.
•
The full Phase 1 data will be submitted for presentation at an upcoming medical meeting in the first half of 2023.
•
The Company plans to initiate a Phase 1/2 study in early 2024 to evaluate various dose levels of glycoprotein E (gE).

Plague vaccine candidate funded by the Defense Department (DoD):

•
Part 1 of the Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability in adults of a plague (rF1V) vaccine candidate adjuvanted with CpG 1018 was successfully completed in January 2023.
•
Both CpG 1018 adjuvanted arms met the Part 1 primary endpoint and demonstrated a greater than two-fold increase in antibodies over the alum adjuvanted control arm after two doses.
•
The DoD has approved continuing to Part 2 using a bedside mix of CpG 1018 with the alum adjuvanted rF1V plague vaccine.

FOURTH QUARTER AND FULL YEAR FINANCIAL HIGHLIGHTS

Total Revenue.

•
Total revenue for the fourth quarter of 2022 was $184.5 million, compared to $195.1 million for the fourth quarter of 2021.
•
Total revenue for the full year 2022 was $722.7 million, compared to $439.4 million for the full year 2021.

Product Revenue, Net.

HEPLISAV-B

•
HEPLISAV-B vaccine product revenue, net was $34.9 million for the fourth quarter of 2022, compared to $17.2 million for the fourth quarter of 2021.
•
HEPLISAV-B vaccine product revenue, net was $125.9 million for the full year 2022, compared to $61.9 million for the full year 2021, representing annual growth of 104%.

CpG 1018 Adjuvant Supply for COVID-19 Vaccines

•
CpG 1018 adjuvant product revenue, net was $147.2 million in the fourth quarter of 2022, compared to $177.4 million in the fourth quarter of 2021.
•
CpG 1018 adjuvant product revenue, net was $587.7 million for the full year 2022, compared to $375.2 million for the full year 2021.
Cost of Sales – Product. Cost of sales – product for the fourth quarter of 2022 increased to $77.5 million, compared to $74.0 million for the fourth quarter of 2021. Full year 2022 cost of sales – product was $262.2 million compared to $173.6 million for the full year 2021. The increase was due to higher sales volume for HEPLISAV-B and CpG 1018 adjuvant in 2022.

Research and Development Expenses (R&D). R&D expenses for the fourth quarter of 2022 increased to $12.9 million, compared to $11.1 million for the fourth quarter of 2021. Full year 2022 R&D expenses were $46.6 million compared to $32.2 million for the full year 2021. The increase was primarily driven by continued investments in our product candidates utilizing CpG 1018 adjuvant through pre-clinical and clinical collaborations and additional discovery efforts.

Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the fourth quarter of 2022 increased to $31.0 million, compared to $29.2 million for the fourth quarter of 2021. Full year 2022 SG&A expenses were $131.4 million compared to $100.2 million for the full year 2021. The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts to increase market share and maximize the Centers for Disease Control and Prevention’s Advisory Committee of Immunization Practices (ACIP) universal recommendation.

Net Income. GAAP net income was $67.7 million, or $0.53 per share (basic) and $0.45 per share (diluted) in the fourth quarter of 2022, compared to GAAP net income of $99.8 million, or $0.80 per share (basic) and $0.55 per share (diluted) in the fourth quarter of 2021. GAAP net income was $293.2 million, or $2.32 per share (basic) and $1.97 per share (diluted) for the full year 2022, compared to GAAP net income was $76.7 million, or $0.62 per share (basic) and $0.57 per share (diluted) for the full year 2021.

Cash and Marketable Securities. Cash and marketable securities were $624.4 million as of December 31, 2022.

Conference Call and Webcast Information

Dynavax will host a conference call and live audio webcast on Thursday, February 23, 2023, at 4:30 p.m. (ET)/1:30 p.m. (PT). The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company’s website at View Source A replay of the webcast will be available for 30 days following the live event.

To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call.

Important U.S. Product Information
HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, please visit the following website at View Source, and click the "Prescribing Information" link in the "Important Safety Information" section.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%).