UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): October 22, 2019
Zyla Life Sciences
(Exact name of Registrant as specified in its charter)
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Delaware |
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001-36295 |
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46-3575334 |
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(State or Other Jurisdiction of |
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(Commission |
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(I.R.S. Employer |
600 Lee Road, Suite 100
Wayne, Pennsylvania 19087
(610) 833-4200
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive
Offices)
Not Applicable
(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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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:
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Title of each class: |
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Trading Symbol(s): |
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Name of each exchange on which registered: |
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Common Stock, par value $0.001 per share |
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ZCOR |
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OTCQX |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company x
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. x
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Resignation of Robert Radie
Effective October 22, 2019, Robert S. Radie, the President and Chief Executive Officer and a director of Zyla Life Sciences (the “Company”) voluntarily resigned as President and Chief Executive Officer and as a director of the Company. Mr. Radie’s decision to resign as a director does not arise from any disagreement with the Company on any matter relating to the Company’s operations, policies or practices. Mr. Radie will continue as the Company’s principal financial officer through the end of 2019.
Election and Appointment of Todd Smith
Effective upon Mr. Radie’s resignation, the Board of Directors of the Company elected Todd N. Smith to serve as the Company’s President and Chief Executive Officer and appointed him as a director. There are no arrangements or understandings between Mr. Smith and any other persons pursuant to which he was selected as President and Chief Executive Officer or as a director. There are also no family relationships between Mr. Smith and any director or executive officer of the Company and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Before joining the Company, from 2017 through February 2019, Mr. Smith, 50, served as the Chief Executive Officer and a director of Iroko Pharmaceuticals Inc., a privately owned pharmaceutical company. During the period October 2014 through June 2015, Mr. Smith served as the Chief Commercial Officer of Ophthotech Corporation, a public biopharmaceutical company focused on developing novel therapeutics to treat ophthalmic diseases. Since 2014, Mr. Smith has also held multiple senior roles at privately owned pharmaceutical and medical device companies, including as a Chief Executive Officer and a director. Additionally, he has held a variety of senior commercial and marketing roles at organizations including Horizon Therapeutics plc (formerly known as Horizon Pharma plc), a public biopharmaceutical company focused on rare and rheumatic diseases, and Abbott Laboratories, a public healthcare products company. Through his executive leadership at Iroko Pharmaceuticals Inc. and other companies, Mr. Smith contributes extensive business and management experience operating pharmaceutical companies such as the Company.
A copy of the press release announcing the transition is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
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Exhibit Number |
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Description |
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99.1 |
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Dated: October 23, 2019 |
ZYLA LIFE SCIENCES | ||
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By: |
/s/ Mark Strobeck | |
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Name: |
Mark Strobeck |
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Title: |
Executive Vice President and Chief Operating Officer |
Zyla Life Sciences Announces Management Changes
WAYNE, Pa., October 23, 2019 — Zyla Life Sciences (OTCQX: ZCOR) (“Zyla”), a commercial-stage life sciences company, today announced that Robert Radie, has resigned as president, chief executive officer and director of the Company to pursue other opportunities. Mr. Radie will continue to serve as principal financial officer until December 31, 2019 in order to ensure a smooth transition. Additionally, the Company announced the appointment of Todd N. Smith as president, chief executive officer and director, effective immediately.
“On behalf of the board, I want to thank Bob for his contributions and service to Zyla and its leadership team during the last seven years,” said Timothy P. Walbert, chairman of the board, Zyla. “I would also like to welcome Todd Smith to the Company. He is an accomplished executive with significant experience driving deal making and commercial success in different therapeutic areas and I am confident that he will continue that track record at Zyla.”
Mr. Smith has more than 25 years of experience in the biopharmaceutical industry. Before joining the Company, from 2017 through February 2019, Mr. Smith, served as chief executive officer and a director of Iroko Pharmaceuticals Inc., a privately-owned pharmaceutical company, from which the Company purchased five products in early 2019. During the period October 2014 through June 2015, Mr. Smith served as the chief commercial officer of Ophthotech Corporation, a biopharmaceutical company focused on developing novel therapeutics to treat ophthalmic diseases. Since 2014, Mr. Smith has also held multiple senior roles at privately owned pharmaceutical and medical device companies. Additionally, he has held a variety of senior commercial and marketing roles at organizations including Horizon Therapeutics plc, a public biopharmaceutical company focused on rare and rheumatic diseases, and Abbott, a public healthcare products company.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the word “will,” or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain, including, but not limited to, risks related to: anticipated benefits of our acquisition of products from Iroko Pharmaceuticals, Inc. and its affiliates and the impact of the acquisition on our earnings, capital structure, strategic plan and results of operations; our ability to continue as a going concern, including our ability to access cash when necessary; our ability to comply with our debt covenants; the impact of our bankruptcy on our business going forward, including with regard to relationships with vendors and customers, employee attrition and the costs and expenses resulting from our bankruptcy; the trading price of our common stock and the liquidity
of the trading market with respect thereto; our ability to satisfy the initial listing requirements of the Nasdaq Stock Market; our ability to maintain our key license arrangements, including our license agreement with iCeutica Inc., which has alleged a material breach thereof; our ability to recruit or retain key scientific or management personnel or to retain our executive officers; our ability to obtain and maintain regulatory approval of our products and the labeling claims that we believe are necessary or desirable for successful commercialization of our products; the impact of strengthening any of the labels for our products; our ability to maintain the intellectual property position of our products; our ability to operate our business without infringing the intellectual property rights of others; our ability to identify and reliance upon qualified third parties to manufacture our products, particularly single source suppliers; our ability to execute on our sales and marketing strategy, including developing relationships with customers, physicians, payors and other constituencies and differentiating our products in a crowded therapeutic area; our ability to commercialize our products, and to do so successfully; the rate and degree of receptivity in the marketplace and among physicians to our products; the costs of commercialization activities, including marketing, sales and distribution; the size and growth potential of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the impact of commercial access wins on patient access to our products; the entry of any generic products for SPRIX Nasal Spray or our other products or the loss of exclusivity with regard to any of our licenses; any delay in or inability to reformulate SPRIX Nasal Spray; our ability to find and hire qualified sales professionals; the success of products that compete with our products that are or become available; the regulatory environment and recently enacted and future legislation and regulations regarding the healthcare system, including relating to social concerns about limiting the use of opioids; the outcome of any litigation or disputes in which we are or may be involved; our ability to integrate and grow any businesses or products that it may acquire; and general market conditions.
You should refer to the “Risk Factors” section of our most recent Annual Report on Form 10-K and our other filings with the United States Securities and Exchange Commission for a discussion of additional important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements included herein or that may be made elsewhere from time to time by, or on behalf of, us. Furthermore, such forward-looking statements speak only as of the date of this report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
About Zyla Life Sciences
Zyla is a commercial life sciences business committed to bringing important medicines to patients and healthcare providers. The company is currently focused on marketing its portfolio of medicines for pain and inflammation. Zyla’s portfolio includes seven medicines: SPRIX® (ketorolac tromethamine) nasal spray, ZORVOLEX® (diclofenac), VIVLODEX® (meloxicam), TIVORBEX® indomethacin), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension
and OXAYDO® (oxycodone HCI, USP) tablets for oral use only — CII. To augment its portfolio, Zyla is seeking to acquire additional development candidates or approved medicines to develop and commercialize.
For full prescribing information, boxed warnings and medication guides, please visit the following sites for each product: sprix.com, vivlodex.com, zorvolex.com, tivorbex.com and oxaydo.com. Prescribing information, the boxed warning and medication guide for INDOCIN suppositories and oral suspension can be found at dailymed.nlm.nih.gov.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: ir@zyla.com
Tel: 484-259-7370