RedHill Biopharma Ltd 6-K, filed Apr 2, 2020
RedHill Biopharma Ltd. (RDHL)
About this 6-K
RedHill Biopharma Ltd filed this 6-K on April 2, 2020.
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549
Form 6-K
Report of Foreign Private IssuerPursuant to Rule 13a-16 or 15d-16of the Securities Exchange Act of 1934
For the month of April 2020 Commission File No.: 001-35773
REDHILL BIOPHARMA LTD. (Translation of registrant's name into English)
21 Ha'arba'a Street, Tel Aviv, 6473921, Israel (Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F [ X ] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On March 31, 2020, RedHill Biopharma Ltd. (the “Company”), through its wholly-owned subsidiary RedHill Biopharma Inc. (“RedHill US”), completed its recently announced acquisition of the global rights, excluding Europe, Canada and Israel, to Movantik^®^ from AstraZeneca AB.
On March 31, 2020, the Company and RedHill US also entered into an amendment (the “Amendment”) to the credit agreement, dated as of February 23, 2020 (the “Credit Agreement”), by and among the Company, RedHill US, HCR Collateral Management, LLC, as administrative agent (“HCR”), and the lenders from time to time party thereto, to, among other things, amend the covenant set forth in Section 8.16 of the Credit Agreement by increasing the specified level of cash liquidity the Company and RedHill US must maintain while the Company and RedHill US negotiate with HCR certain other potential changes to the Credit Agreement. Except as set forth in the Amendment, which was effective as of March 31, 2020, the terms of the Credit Agreement remain unchanged. The foregoing description is only a summary of the material provisions of the Amendment and is qualified in its entirety by reference to the copy of the Amendment attached hereto as Exhibit 1.
Attached hereto and incorporated by reference herein are the following:
Exhibit 1: First Amendment to Credit Agreement, dated as of March 31, 2020, by and among the Company, RedHill US, HCR and the lenders party thereto.
Exhibit 99.1: The Company’s press release entitled “RedHill Biopharma Completes Acquisition of Movantik^®^ from AstraZeneca”.
This Form 6-K is incorporated by reference into the Company’s Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122) and on July 24, 2019 (File No. 333-232776) and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on February 25, 2016 (Registration No. 333-209702), on July 23, 2018 (File No. 333-226278) and on July 24, 2019 (File No. 333-232777).
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, thereunto duly authorized.
| REDHILL BIOPHARMA LTD. | |
|---|---|
| (Registrant) | |
| Date: April 2, 2020 | By: /s/ Dror Ben-Asher |
| Dror Ben-Asher | |
| Chief Executive Officer |
Exhibit 1

Execution Version FIRST AMENDMENT TO CREDIT AGREEMENT THIS FIRST AMENDMENT TO CREDIT AGREEMENT (this “ Amendment ”), dated as of March 31 , 2020 (the “ Amendment Effective Date ”), is made by and among REDHILL BIOPHARMA INC . , a Delaware corporation (the “ Borrower ”), REDHILL BIOPHARMA LTD . , a company incorporated under the laws of the State of Israel, as Guarantor (“ RedHill Parent ”), the Lenders (defined in the Credit Agreement), HCR COLLATERAL MANAGEMENT, LLC , as Administrative Agent (“ Agent ”) and those additional entities that hereafter become parties to the Credit Agreement in accordance with the terms thereof by executing a Joinder Agreement . The Borrower, RedHill Parent, the Lenders and Agent are parties to a Credit Agreement dated as of February 23 , 2020 (as amended, restated, modified or supplemented from time to time, the “ Credit Agreement ”) . The Borrower, RedHill Parent, the Lenders and Agent agree to certain amendments to the Credit Agreement. Accordingly, the parties hereto agree as follows: SECTION 1 Definitions; Interpretation. (a) Terms Defined in Credit Agreement . All capitalized terms used in this Amendment (including in the recitals hereof) and not otherwise defined herein shall have the meanings assigned to them in the Credit Agreement. (b) Interpretation . The rules of interpretation set forth in Section 1.02 of the Credit Agreement shall be applicable to this Amendment and are incorporated herein by this reference. SECTION 2 Amendments to the Credit Agreement. (a) The Credit Agreement shall be amended as follows effective as of the Amendment Effective Date: (i) Section 1.01 is hereby amended to add the following term and definition in appropriate alphabetical order: “ Aether Litigation ” means Aether Therapeutics Inc. v. Astrazeneca AB, et al. (Case No. CIV: 1:20 - cv - 00381) before the District Court (including, for the avoidance of doubt, if any Person appears as a plaintiff or defendant in such litigation after the date hereof). “ District Court ” means the United States District Court for the District of Delaware. (ii) Section 8.16 is hereby amended in its entirety and replaced with the following: “8.16 Liquidity. (a) Permit, on any Business Day, cash and Cash Equivalents, in each case, of the Loan Parties held in Deposit Accounts and Securities Accounts for which the Administrative Agent shall have received an effective Control Agreement at any time to be less than (i) $7,500,000, from the Closing Date to the earlier of (x) the Term Loan Maturity Date and (y) the Tranche B Funding Date, (ii) $20,000,000, from the Tranche B Funding Date to the earlier of (x) the Term Loan Maturity Date and (y) the Tranche C Funding Date, (iii) $25,000,000, from the Tranche C Funding Date to the earlier of (x) the Term Loan Maturity Date and (y) the Tranche D Funding Date and (iv) $28,750,000, from the Tranche D Funding Date to the Term Loan Maturity Date. (b) The Loan Parties and the Administrative Agent hereby agree to negotiate in good faith (with due regard for the procedural posture, facts and other relevant considerations related to the Aether Litigation) an amendment to the Credit Agreement that shall add provisions accounting for the Aether Litigation and risks to RedHill Parent and/or its Subsidiaries associated 223030966 v8

with U.S. Patent Nos. 8,748,448, 8,883,817 and 9,061,024 in connection therewith in a manner mutually acceptable to the Administrative Agent and the Loan Parties (the “Aether Litigation Amendment”). Beginning on the date, if any, upon which the Aether Litigation Amendment becomes effective, the Credit Agreement shall be modified as provided therein and paragraph (a) of this Section 8.16 shall cease to apply and shall be replaced in its entirety as follows: Permit, on any Business Day, cash and Cash Equivalents, in each case, of the Loan Parties held in Deposit Accounts and Securities Accounts for which the Administrative Agent shall have received an effective Control Agreement at any time to be less than (i) $6,000,000, from the Closing Date to the earlier of (x) the Term Loan Maturity Date and (y) the Tranche B Funding Date, (ii) $16,000,000, from the Tranche B Funding Date to the earlier of (x) the Term Loan Maturity Date and (y) the Tranche C Funding Date, (iii) $20,000,000, from the Tranche C Funding Date to the earlier of (x) the Term Loan Maturity Date and (y) the Tranche D Funding Date and (iv) $23,000,000, from the Tranche D Funding Date to the Term Loan Maturity Date. (b) References Within Credit Agreement . Each reference in the Credit Agreement to “this Agreement” and the words “hereof,” “herein,” “hereunder,” or words of like import, shall mean and be a reference to the Credit Agreement as amended by this Amendment . SECTION 3 Conditions of Effectiveness . The effectiveness of this Amendment shall be subject to the satisfaction of each of the following conditions precedent : (a) This Amendment . Agent shall have received this Amendment, executed by the Borrower and RedHill Parent . (b) Representations and Warranties ; No Default . On the Amendment Effective Date, after giving effect to the amendment of the Credit Agreement contemplated hereby : (i) The representations and warranties contained in Section 4 shall be true and correct on and as of the Amendment Effective Date as though made on and as of such date; and (ii) There exist no Events of Default or events that with the passage of time would result in an Event of Default . SECTION 4 Representations and Warranties . To induce the Lenders to enter into this Amendment, the Borrower and RedHill Parent hereby confirms, as of the date hereof, (a) that the representations and warranties made by it in Article VI of the Credit Agreement and in the other Loan Documents are true and correct in all material respects ; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof ; and (b) that there has not been and there does not exist a Material Adverse Effect . For the purposes of this Section 4 , (i) each reference in Section 6 of the Credit Agreement to “this Agreement,” and the words “hereof,” “herein,” “hereunder,” or words of like import in such Section, shall mean and be a reference to the Credit Agreement as amended by this Amendment, and (ii) any representations and warranties which relate solely to an earlier date shall not be deemed confirmed and restated as of the date hereof (provided that such representations and warranties shall be true, correct and complete in all material respects as of such earlier date) . SECTION 5 Miscellaneous . (a) Loan Documents Otherwise Not Affected ; Reaffirmation . Except as expressly amended pursuant hereto or referenced herein, the Credit Agreement and the other Loan Documents shall remain unchanged and in full force and effect and are hereby ratified and confirmed in all respects . The Lenders’ and Agent’s execution and delivery of, or acceptance of, this Amendment shall not be deemed to create a course of dealing or otherwise create any express or implied duty by any of them to provide any other or further amendments, consents or waivers in the future . The Borrower and RedHill Parent hereby reaffirms the grant of security under the Collateral Documents 223030966 v8

223030966 v8 and hereby reaffirms that such grant of security in the Collateral secures all Obligations under the Credit Agreement, including without limitation any Loans funded on or after the Amendment Effective Date, as of the date hereof. (b) Conditions . For purposes of determining compliance with the conditions specified in Section 3 , each Lender that has signed this Amendment shall be deemed to have consented to, approved or accepted or to be satisfied with, each document or other matter required thereunder to be consented to or approved by or acceptable or satisfactory to a Lender unless Agent shall have received notice from such Lender prior to the Amendment Effective Date specifying its objection thereto . (c) Release . In consideration of the agreements of Agent and each Lender contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Borrower and RedHill Parent, each on behalf of itself and its successors, assigns, and other legal representatives, hereby fully, absolutely, unconditionally and irrevocably releases, remises and forever discharges Agent and each Lender, and its successors and assigns, and its present and former shareholders, affiliates, subsidiaries, divisions, predecessors, directors, officers, attorneys, employees, agents and other representatives (Agent, Lenders and all such other persons being hereinafter referred to collectively as the “ Releasees ” and individually as a “ Releasee ”), of and from all demands, actions, causes of action, suits, covenants, contracts, controversies, agreements, promises, sums of money, accounts, bills, reckonings, damages and any and all other claims, counterclaims, defenses, rights of set - off, demands and liabilities whatsoever of every name and nature, known or unknown, suspected or unsuspected, both at law and in equity, which Borrower and RedHill Parent, or any of their successors, assigns, or other legal representatives may now or hereafter own, hold, have or claim to have against the Releasees or any of them for, upon, or by reason of any circumstance, action, cause or thing whatsoever which arises at any time on or prior to the day and date of this Amendment, including, without limitation, for or on account of, or in relation to, or in any way in connection with the Credit Agreement, or any of the other Loan Documents or transactions thereunder or related thereto . Borrower and RedHill Parent understand, acknowledge and agree that the release set forth above may be pleaded as a full and complete defense and may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of the provisions of such release . Borrower and RedHill Parent agree that no fact, event, circumstance, evidence or transaction which could now be asserted or which may hereafter be discovered shall affect in any manner the final, absolute and unconditional nature of the release set forth above . (d) No Reliance . Borrower and RedHill Parent hereby acknowledge and confirm to Agent and the Lenders that the Borrower and RedHill Parent are executing this Amendment on the basis of their own investigation and for their own reasons without reliance upon any agreement, representation, understanding or communication by or on behalf of any other Person . (e) Costs and Expenses . The Borrower agrees to pay to Agent within ten ( 10 ) days of its receipt of an invoice, the reasonable out - of - pocket costs and expenses of Agent and the Lenders party hereto, and the reasonable fees and disbursements of counsel to Agent and the Lenders party hereto (including allocated costs of internal counsel), in connection with the negotiation, preparation, execution and delivery of this Amendment and any other documents to be delivered in connection herewith on the Amendment Effective Date or after such date . (f) Binding Effect . This Amendment binds and is for the benefit of the successors and permitted assigns of each party . (g) Governing Law . THIS AMENDMENT AND ANY CLAIMS, CONTROVERSY, DISPUTE OR CAUSE OF ACTION (WHETHER IN CONTRACT OR TORT OR OTHERWISE) BASED UPON, ARISING OUT OF OR RELATING TO THIS AMENDMENT AND THE TRANSACTIONS CONTEMPLATED HEREBY AND THEREBY SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAW OF THE STATE OF NEW YORK . (h) Complete Agreement ; Amendments . This Amendment and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements with respect to such subject matter . All prior agreements, understandings, representations, warranties, and negotiations between the parties about the subject matter of this Amendment and the Loan Documents merge into this Amendment and the Loan Documents .

223030966 v8 (i) Severability of Provisions . Each provision of this Amendment is severable from every other provision in determining the enforceability of any provision . (j) Counterparts . This Amendment may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Amendment . Delivery of an executed counterpart of a signature page of this Amendment by facsimile, portable document format ( . pdf) or other electronic transmission will be as effective as delivery of a manually executed counterpart hereof . (k) Loan Documents . This Amendment and the documents related thereto shall constitute Loan Documents . [Balance of Page Intentionally Left Blank; Signature Pages Follow]

IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above written. BORROWER: REDHILL BIOPHARMA INC. By Name: Title: By N a m e: Dror Ben - Asher Title: Di rector [ Signature Page to First Amendment to Credit Agreement ]

By Name: Title: GUARANTOR: REDHILL BIOPHARMA LTD. By Name: Dror Ben - Asher Title: CEO [ Signature Page to First Amendment to Credit Agreement ]

ADMINSTRATIVE AGENT: HCR COLLATERAL MANAGEMENT, LLC By Name: Clarke B. Futch Title: Managing Partner [ Signature Page to First Amendment to Credit Agreement ]

LENDERS: HCR Stafford Fund, L.P. By HCR Stafford Fund GP, LLC, its general partner By Name: Clarke B. Futch Title: Managing Partner HCR Molag Fund, L.P. By HCR Molag Fund GP, LLC, its general partner By Name: Clarke B. Futch Title: Managing Partner HCR Potomac Fund, L.P. By HCR Potomac Fund GP, LLC, its general partner By Name: Clarke B. Futch Title: Managing Partner HCRP Overflow Fund, L.P. By HCRP Overflow Fund GP, LLC, its general partner By Name: Clarke B. Futch Title: Managing Partner HealthCare Royalty Partners IV, L.P. By HealthCare Royalty GP IV, LLC, its general partner By Name: Clarke B. Futch Title: Managing Partner [ Signature Page to First Amendment to Credit Agreement ]
EdgarFiling EXHIBIT 99.1
RedHill Biopharma Completes Acquisition of Movantik® from AstraZeneca
RedHill to promote Movantik^®^ in the U.S. to expanded call points, including gastroenterologists, primary care physicians and additional specialists, along with Talicia^®^ and Aemcolo^®^
Movantik^®^ generated U.S. net sales of $96 million in 2019
TEL-AVIV, Israel and RALEIGH, N.C., April 02, 2020 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company focused on gastrointestinal diseases, today announced that it has completed the recently announced acquisition of the global rights, excluding Europe, Canada and Israel, to Movantik^®^ (naloxegol)^1^, for the treatment of opioid-induced constipation (OIC)^2^ from AstraZeneca (LSE/STO/NYSE: AZN).
“We are expanding the promotion of Movantik^®^ with our current sales force of approximately 100 sales representatives. Given the excellent work that AstraZeneca has done to date, we expect a smooth transition of all commercial activities. We are excited for the opportunity to grow the call points for Movantik^®^ and offer more patients this preferred treatment for opioid-induced constipation,” said Rick Scruggs, Chief Commercial Officer of RedHill.
Adi Frish, Senior VP Business Development and Licensing of RedHill added: “We are delighted to add Movantik^®^ to our GI-focused commercial basket. We will continue to aggressively drive both organic and non-organic growth following the launches of Aemcolo^®^and Talicia^®^ and the acquisition of Movantik^®^.”
Movantik^®^ is the first oral peripherally acting mu-opioid receptor antagonist (PAMORA) approved in the U.S. for OIC. It is recommended by the American Gastroenterological Association (AGA) guidelines^3^ and the National Comprehensive Cancer Network (NCCN) guidelines. OIC is the most prevalent and disabling adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year^4^. Movantik^®^ generated U.S. net sales of $96 million in 2019 and is the number one prescribed PAMORA^5^. The acquisition of Movantik^®^was supported by a non-dilutive acquisition financing by HealthCare Royalty Partners (HCR).
SVB Leerink acted as exclusive financial advisor and Cravath, Swaine & Moore LLP acted as special transaction counsel to RedHill on the transaction.
About Movantik^®^ Movantik^®^ is a proprietary once-daily oral PAMORA approved by the U.S. Food and Drug Administration for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation. Movantik^®^is the first oral PAMORA approved in the U.S. for the treatment of OIC and is recommended by the American Gastroenterological Association (AGA) guidelines^6^ and the National Comprehensive Cancer Network (NCCN) guidelines. Movantik^®^ is part of the exclusive worldwide license agreement announced in 2009 between AstraZeneca and Nektar Therapeutics. It was developed using Nektar’s oral small-molecule polymer conjugate technology. Movantik^®^ was first approved in 2014 and launched in the U.S. by AstraZeneca and Daiichi Sankyo in 2015. Further information about Movantik^®^ is available at: www.Movantik.com.
About Opioid-Induced Constipation (OIC)
OIC is a condition caused by prescription opioid pain medicines. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC. OIC is the most prevalent and disabling adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year^4^.
About RedHill Biopharma Ltd. RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company focused on gastrointestinal diseases. RedHill promotes the gastrointestinal drugs, Talicia^®^ for the treatment of Helicobacter pylori (H. pylori) infection in adults^7^, Aemcolo^®^ for the treatment of travelers’ diarrhea in adults^8^ and Movantik^®^for opioid-induced constipation (OIC) in adults. RedHill’s key clinical late-stage development programs include: (i) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (ii) RHB-204, with a planned pivotal Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (iii) RHB-102 (Bekinda^®^), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) Opaganib (Yeliva^®^), a first-in-class SK2 selective inhibitor, targeting multiple oncology, inflammatory and gastrointestinal indications, with an ongoing Phase 1/2a study for cholangiocarcinoma; (v) RHB-106, an encapsulated bowel preparation, and (vi) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases. More information about the Company is available at www.redhillbio.com.
IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK^®^
- Movantik^®^may cause serious side effects, including:
- Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with Movantik^®^, including sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. Patients taking methadone to treat their pain may be more likely to experience stomach pain and diarrhea. Tell your doctor if you have any of these symptoms
- Severe Stomach Pain and/or Diarrhea. This can happen within a few days of starting Movantik^®^ and can lead to hospitalization. If either of these side effects occurs, stop taking Movantik^®^ and call your doctor immediately
- Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that gets worse or does not go away, stop taking Movantik^®^ and get emergency medical help right away
- Do not take Movantik^®^if you:
- Have a bowel blockage (intestinal obstruction) or have a history of bowel blockage
- Are allergic to Movantik^®^ or any of the ingredients in Movantik^®^
- Movantik^®^ can interact with other medicines and cause side effects, including opioid withdrawal symptoms (see symptoms above). Tell your doctor or pharmacist before you start or stop any medicines during treatment with Movantik^®^
- Before you take Movantik^®^, tell your doctor about all of your medical conditions, including if you:
- Have any stomach, bowel (intestines), kidney, or liver problems
- Are pregnant or plan to become pregnant. Taking Movantik^®^ during pregnancy may cause opioid withdrawal symptoms in you or your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Movantik^®^
- Are breastfeeding or plan to breastfeed. It is not known if Movantik^®^ passes into your breast milk. Taking Movantik^®^ while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take Movantik^®^ or breastfeed. You should not breastfeed if you take Movantik^®^
- Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way Movantik^®^ works
- If you stop taking your opioid pain medicine, stop taking Movantik^®^ and tell your doctor
- Avoid eating grapefruit or drinking grapefruit juice during treatment with Movantik^®^
- The most common side effects of Movantik^®^ include: Stomach (abdomen) pain, diarrhea, nausea, gas, vomiting, headache, and excessive sweating
APPROVED USE FOR MOVANTIK^®^
Movantik^®^ is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by active cancer.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks related to the transition of all commercial activities from AstraZeneca and the timing of hiring sales representatives as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its therapeutic candidates and its FDA-approved products; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia^®^; (v) the Company’s ability to successfully commercialize and promote Talicia^®^, Aemcolo^®^and Movantik^®^; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company’s industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
| **** Company contact:<br>Adi Frish<br>Senior VP Business Development & Licensing<br>RedHill Biopharma<br>+972-54-6543-112<br>adi@redhillbio.com | IR contact (U.S.):<br>Timothy McCarthy, CFA, MBA<br>Managing Director, Relationship Manager<br>LifeSci Advisors, LLC<br>+1-212-915-2564<br>tim@lifesciadvisors.com |
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^1^ Full prescribing information for Movantik^®^ (naloxegol) is available at: www.Movantik.com.
^2^ Movantik^®^ is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation.
^3^ Crockett, Seth D., et al. "American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation." Gastroenterology 156.1 (2019): 218-226.
^4^ Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.
^5^ Symphony Health, accessed January 2020.
^6^ Crockett, Seth D., et al. American Gastroenterological Association Institute guideline on the medical management of opioid-induced constipation, Gastroenterology 156.1 (2019): 218-226.
^7^ Full prescribing information for Talicia^®^(omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
^8^ Full prescribing information for Aemcolo^®^(rifamycin) is available at: www.Aemcolo.com.