On April 4, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that a permanent J-code, J9359, has been issued for ZYNLONTA by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2022 (Press release, ADC Therapeutics, APR 4, 2022, View Source [SID1234611401]).

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J-codes are permanent reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B injectable drugs like ZYNLONTA that are administered by a physician. Claims submission and documentation are simplified with a permanent J-code, facilitating and streamlining the billing and reimbursement process.

The permanent J-code for ZYNLONTA, J9359 (Injection, loncastuximab tesirine-lpyl, 0.075 mg), took effect April 1, 2022. The permanent J-code is also published online on the CMS website here.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On April 4, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Quality, Affordable Self-Care Products, reported that it has launched a private offering (the "Offering") of $500 million aggregate principal amount of senior notes due 2030 (the "Notes"), subject to market and other conditions, through its indirect wholly-owned subsidiaries, Perrigo Investments, LLC and Perrigo Investments Capital, Inc. (together, the "Issuers") (Press release, Perrigo Company, APR 4, 2022, View Source [SID1234611400]).

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The Company intends to use the net proceeds from the Offering, together with cash on hand and borrowings under the term loan facilities of its previously-announced syndication of new senior secured credit facilities, to finance the proposed acquisition (the "Acquisition") of Héra SAS ("Héra") and to refinance certain existing indebtedness of the Company and its subsidiaries, including its outstanding term loan facility, its 4.00% Senior Notes due 2023 and its 5.1045% Guaranteed Senior Notes due 2023.

The Notes are expected to be fully and unconditionally guaranteed on a senior unsecured basis by Perrigo and each of Perrigo’s subsidiaries that provide guarantees under the new senior secured credit facilities.

The closing of the Offering is not conditioned on, and it is expected that the Offering will be consummated prior to, the closing of the Acquisition. Concurrently with the closing of the Offering, the Issuers expect to deposit into a segregated escrow account an amount of cash equal to the gross proceeds of the Offering, plus the amount of interest that will accrue on the Notes to and including December 31, 2022. If (i) the Acquisition has not been consummated on or prior to December 31, 2022, (ii) the acquisition agreement is terminated in accordance with its terms, or (iii) the Acquisition is otherwise abandoned, the Issuers will be required to redeem all of the Notes at a redemption price equal to 100% of their principal amount, plus accrued and unpaid interest to, but excluding, the redemption date.

The terms of the proposed refinancing, including but not limited to the principal amount and interest rate of the Notes, and the consummation of the acquisition of Héra, are subject to a number of significant conditions, and there can be no assurance that the Company will consummate any of these transactions on the anticipated terms or timing, or at all.

The Offering will be made in a private transaction in reliance upon an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), only to investors who are reasonably believed to be "qualified institutional buyers," as that term is defined in Rule 144A under the Securities Act, and to non-U.S. persons outside of the United States pursuant to Regulation S under the Securities Act. The Notes have not been registered under the Securities Act or the securities laws of any other jurisdiction and may not be offered or sold in the United States without registration or an applicable exemption from, or in a transaction not subject to, such registration requirements.

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

On April 4, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported abstract acceptance with a poster presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in New Orleans from April 8-13, 2022 (Press release, Spectrum Pharmaceuticals, APR 4, 2022, View Source [SID1234611399]).

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Session title and information for the poster is listed below and is now available on the AACR (Free AACR Whitepaper) online itinerary planner.

Predictive ability of circulating tumor DNA by Guardant360 in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations
Session Title: PO.CL11.03 – Cell-Free DNA 2
Session Date and Time: Tuesday, April 12, 2022; 1:30 PM – 5:00 PM CT
Location: New Orleans Convention Center, Section 31
Abstract / Poster: 3400 / 6

Copies of the presentation will be available on Spectrum’s website at View Source following presentation at the meeting.

On April 4, 2022 Herantis Pharma Plc ("Herantis" or the "Company"), an innovative biotech company developing new disease modifying therapies for Parkinson’s disease, reported on 30 March 2022 the result of the offering of new shares (the "Placing Shares") in a directed share issue to institutional and other qualified investors (the "Directed Issue") (Press release, Herantis Pharma, APR 4, 2022, View Source;975-000-new-shares-registered-with-the-trade-register,c3539149 [SID1234611398]). In the Directed Issue, the Company issued a total of 975,000 Placing Shares. The Placing Shares have today been registered with the trade register maintained by the Finnish Patent and Registration Office.

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Following the registration of the Placing Shares, the total number of registered shares in the Company is 12,078,568. The Placing Shares will be issued in the book-entry system (ISIN code FI4000087861) on or about 5 April 2022. After this, and registration on the investors’ book-entry accounts, the Placing Shares will confer shareholder rights in the Company. The Placing Shares are expected to be ready for delivery to the investors through Euroclear Finland Oy or, as applicable, through Euroclear Sweden AB on or about 5 April 2022.

Trading in the Placing Shares is expected to commence on Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden on or about 6 April 2022.

On April 4, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that it expected to file its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the "Annual Report") in the near term (Press release, Supernus, APR 4, 2022, View Source [SID1234611396]).

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Full Year 2022 Financial Guidance (GAAP)

(1) Includes net product sales and royalty revenue.
(2) Includes amortization of intangible assets and contingent consideration expense (gain).

Full Year 2022 Financial Guidance — GAAP to Non-GAAP Adjustments

Non-GAAP Financial Information
The Company’s 2022 financial guidance in this press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjusts for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings measure is useful supplemental information to investors regarding the Company’s results of operations and assists management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measure. Including such measure may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measures to the most comparable GAAP financial measures. Investors are encouraged to review the reconciliation.