8-K
Prothena Corp Public Ltd Co (PRTA)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 8, 2021
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PROTHENA CORPORATION PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
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| Ireland | 001-35676 | 98-1111119 | |||
|---|---|---|---|---|---|
| (State or Other Jurisdiction<br>of Incorporation) | (Commission<br>File Number) | (IRS Employer<br>Identification No.) | |||
| 77 Sir John Rogerson's Quay, Block C | |||||
| Grand Canal Docklands | |||||
| Dublin 2, | D02 VK60, | Ireland | |||
| (Address of principal executive offices, including Zip Code) |
Registrant’s telephone number, including area code: 011-353-1-236-2500
___________________________________________________
(Former Name or Former Address, if Changed Since Last Report.)
___________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | | --- | --- || ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | | --- | --- || ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | | --- | --- || ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | | --- | --- |
Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered |
|---|---|---|
| Ordinary Shares, par value $0.01 per share | PRTA | The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01. Entry into a Material Definitive Agreement.
On July 8, 2021, Prothena Corporation plc (the “Company”), together with its wholly owned subsidiary, Prothena Biosciences Limited (“PBL”), entered into a Share Purchase Agreement (the “Agreement”) with Novo Nordisk A/S (“Novo Nordisk”) and Novo Nordisk Region Europe A/S (“NNRE” and together with Novo Nordisk, “Buyer”), pursuant to which PBL sold and transferred to NNRE (the “Transaction”), all issued and outstanding ordinary shares of Neotope Neuroscience Limited, a wholly owned subsidiary of PBL (“NNL”), for an aggregate purchase price of up to $1.23 billion. The aggregate purchase price consists of an upfront payment of $60 million in cash, subject to customary purchase price adjustments, and an aggregate of $1.17 billion in cash, payable on Buyer’s achievement of certain development, commercialization and net sales-based milestones, $40 million of which is a near-term clinical milestone.
The Company is acting as guarantor of PBL’s obligations under the Agreement.
As part of its development of the ATTR Amyloidosis program, NNL owns and has exclusive licenses to intellectual property rights and other assets pertaining to the investigational humanized monoclonal antibody known as PRX004, which has completed Phase 1 studies for the treatment of hereditary ATTR Amyloidosis. Should Buyer achieve certain stages of development or commercialization for products or product candidates containing PRX004 or a derivative thereof in ATTR Amyloidosis, the development and commercialization milestones entitle PBL to receive specified milestone payments. The development and commercialization milestone payments will be discounted if the milestone events are achieved with respect to other indications. Should Buyer achieve specified thresholds of worldwide, annual net sales of the milestone products, regardless of indication, PBL will be entitled to receive specified one-time net sales milestone payments. All milestone payments attributable to an achieved milestone will be paid to PBL, subject to Buyer’s offset right for indemnity claims or unpaid amounts in respect of any purchase price adjustment, as discussed in more detail below.
The Agreement contains customary representations, warranties and covenants made by each of PBL and Buyer, including, among others, covenants by Buyer to use certain efforts to pursue achievement of the development and commercialization milestones, to provide periodic reports on Buyer’s progress toward achieving such milestones as well as net sales reports, and on certain tax matters.
PBL is obligated to indemnify Buyer for breach of representations, warranties and covenants on a range of matters, for certain tax matters and for liabilities relating to a prior program that NNL sold to another subsidiary of PBL in 2020, subject to a deductible and small claims exclusion and certain limits on liability for certain breaches of representations and warranties.
Buyer’s sole recourse with respect to damages resulting from a breach of PBL’s representations and warranties, and with respect to all other claims relating to or arising from the Agreement (excluding fraud, specific performance and the upfront purchase price adjustment), is indemnification by PBL for such damages, subject to certain limitations. Buyer may seek any amounts recoverable through indemnification directly from PBL or offset such amounts against any future milestone payments.
Pursuant to the Agreement, PBL will provide certain transition services to Novo Nordisk and its affiliates for the benefit of NNL until September 30, 2022.
The foregoing description of the terms of the Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed with the
Securities and Exchange Commission as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021.
Item 7.01. Regulation FD Disclosure.
On July 12, 2021, the Company and Novo Nordisk issued a joint press release announcing the Agreement. A copy of that press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The foregoing information in Item 7.01 of this Current Report on Form 8-K, together with the press release attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to Item 7.01 of this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release dated July12, 2021 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
Forward-Looking Statements
The disclosures contained or incorporated by reference in Item 1.01 and Item 7.01 contain forward-looking statements regarding the Agreement and the development of NNL’s products, including the ability of Buyer to successfully research, develop and commercialize the products, the ability of Buyer to obtain regulatory approval to manufacture, market and sell the products in and outside of the United States and the ability for Buyer to achieve the requirements of the milestones set forth in the Agreement in order for PBL to be entitled to the milestone payments. These forward-looking statements involve risks and uncertainties. Actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks and uncertainties described in the Company’s Securities and Exchange Commission (“SEC”) filings, including the “Risk Factors” section of the Quarterly Report on Form 10-Q filed with the SEC on May 11, 2021.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: | July 12, 2021 | PROTHENA CORPORATION PLC | |
|---|---|---|---|
| By: | /s/ Tran B. Nguyen | ||
| Name: | Tran B. Nguyen | ||
| Title: | Chief Operating Officer and Chief Financial Officer |
Document
EXHIBIT 99.1
Prothena and Novo Nordisk Announce Acquisition Agreement for Prothena’s ATTR Amyloidosis Programme
•Prothena is eligible to receive development and sales milestone payments totalling up to 1.2 billion US dollars, including 100 million dollars in upfront and near-term clinical milestone payments
•Novo Nordisk will develop the phase 2-ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy
DUBLIN, Ireland and BAGSVÆRD, Denmark, July 12, 2021 -- Prothena Corporation plc (NASDAQ:PRTA) and Novo Nordisk A/S (Nasdaq Copenhagen: NOVO B) today announced that the companies have entered into a definitive purchase agreement under which Novo Nordisk has acquired Prothena’s clinical stage antibody PRX004 and broader ATTR amyloidosis programme.
PRX004 is a phase 2-ready anti-amyloid immunotherapy designed to deplete the amyloid deposits that are associated with the disease pathology of ATTR amyloidosis.
ATTR amyloidosis is a rare, progressive, and fatal disease characterised by the abnormal buildup of amyloid deposits composed of misfolded transthyretin protein in organs and tissues, most commonly the heart and/or nervous system.
Prothena has completed a phase 1 study with PRX004 in patients with hereditary forms of ATTR, in which PRX004 was found to be safe and well tolerated.
Novo Nordisk will initially focus on the clinical development of PRX004 in ATTR cardiomyopathy - an underdiagnosed and potentially fatal form of ATTR amyloidosis characterised by build-up of amyloid deposits in cardiac tissue.
Under the terms of the definitive purchase agreement, Novo Nordisk acquires Prothena’s wholly-owned subsidiary and gains full worldwide rights to the intellectual property and related rights of Prothena’s ATTR amyloidosis business and pipeline. Prothena is eligible to receive development and sales milestone payments totalling up to 1.2 billion US dollars including 100 million dollars in upfront and near-term clinical milestone payments.
“Today’s announcement is consistent with our commitment to create a better future for patients in critical need of new treatment options. We are confident that Novo Nordisk will leverage its extensive expertise in developing treatments for those affected by cardiovascular diseases to advance this promising potential treatment to patients on an expedited timeline,” said Hideki Garren, MD, PhD, chief medical officer of Prothena. “With Novo Nordisk’s commitment to further develop PRX004 in ATTR cardiomyopathy, Prothena will continue to focus on our
EXHIBIT 99.1
mission to advance our robust portfolio designed to address rare peripheral amyloid and neurodegenerative diseases. We also wish to extend our sincere thanks and appreciation to all the patients and investigators who participated in the PRX004 phase 1 study.”
“With its innovative amyloid-depleting mechanism, PRX004 has the potential to offer a novel treatment option for ATTR cardiomyopathy – an often fatal disease with significant unmet medical need,” said Marcus Schindler, chief scientific officer, EVP Research and Early Development at Novo Nordisk. “This acquisition is a testament to Prothena’s pioneering work in ATTR amyloidosis and Novo Nordisk’s dedication to advancing new disease-modifying therapies for the benefit of people with cardiovascular diseases which are the world’s leading cause of death.”
About PRX004
PRX004 is an investigational humanised monoclonal antibody designed to deplete amyloid associated with disease pathology that underlies hereditary and wild type ATTR amyloidosis (hATTR and wtATTR, respectively), without affecting the native, normal tetrameric form of the protein. It is generally accepted that at the time of diagnosis, affected organs in ATTR patients contain extracellular amyloid deposits that cause organ dysfunction. PRX004 has been shown in preclinical studies to promote clearance of insoluble amyloid fibrils through antibody-mediated phagocytosis and inhibit amyloid formation. This depleter mechanism of action has the potential to provide benefit for ATTR patients at high risk for early mortality due to amyloid deposition in vital organs.
Prothena has completed a Phase 1, open-label, multicenter dose-escalation study (NCT03336580). 21 patients with hereditary ATTR Amyloidosis (hATTR) were enrolled to receive PRX004 intravenously once every 28 days for up to 3 infusions in the dose escalation phase of the study. Patients were enrolled into 1 of the following 6 PRX004 dose cohorts: 0.1, 0.3, 1, 3, 10, and 30 mg/kg. Eligible patients who completed dose-escalation were provided the opportunity to enrol in the long-term extension (LTE) portion of the study. All 21 patients enrolled in the Phase 1 study successfully completed dose-escalation and 17 patients were subsequently enrolled in the LTE. PRX004 was found to be safe and well tolerated across all dose levels.
About Prothena
Prothena Corporation plc is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For
EXHIBIT 99.1
more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
About Novo Nordisk
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 45,800 people in 80 countries and markets its products in around 170 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.
Forward-looking Statements
This press release contains forward-looking statements regarding the definitive purchase agreement and the development of PRX004, including the ability of Novo Nordisk to successfully research, develop and commercialize PRX004, the ability of Novo Nordisk to obtain regulatory approval to manufacture, market and sell the products in and outside of the United States and the ability for Novo Nordisk to achieve the requirements of the milestones set forth in the definitive purchase agreement in order for Prothena to be entitled to the milestone payments. These forward-looking statements involve risks and uncertainties. Actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks and uncertainties described in Prothena’s SEC filings, including the “Risk Factors” section of the Quarterly Report on Form 10-Q filed with the SEC on May 11, 2021.
Contacts:
Prothena Corporation plc Media & Investors
Jennifer Zibuda, Director, Investor Relations & Communications
+1 650 837 8535, jennifer.zibuda@prothena.com
Novo Nordisk Media
Martin Havtorn Petersen
+45 3075 5246, mhpz@novonordisk.com
Novo Nordisk Investors
Daniel Muusmann Bohsen
+45 3075 2175, dabo@novonordisk.com
Ann Søndermølle Rendbæk
+45 3075 2253, arnd@novonordisk.com
David Heiberg Landsted
+45 3077 6915, dhel@novonordisk.com
Mark Joseph Root
+1 848 213 3219, mjhr@novonordisk.com