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Form 8-K AYTU BIOSCIENCE, INC For: Jun 11

June 13, 2018 8:15 AM

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): June 11, 2018

 

AYTU BIOSCIENCE, INC.
(Exact Name of Registrant as Specified in Charter)

 

Delaware   001-38247   47-0883144
(State or Other Jurisdiction
of Incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

373 Inverness Parkway, Suite 206, Englewood, Colorado   80112
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (720) 437-6580

 

 

 

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))

 

Indicate by check mark whether the registrant is an emerging growth company 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 June 11, 2018, Aytu BioScience, Inc. (the “Company”), entered into a license agreement (the “License Agreement”) with Magna Pharmaceuticals, Inc. (“Magna”). Pursuant to the License Agreement, Magna granted to the Company an exclusive, sub-licensable, royalty-bearing license in the United States and Canada related to Zolpimist. The License Agreement may be terminated by either the Company or Magna on the occurrence of a material breach of the License Agreement and by the Company in its discretion upon a sixty (60) day prior written notice and the payment of a certain termination fee. As consideration for the license granted, the Company made a cash payment to Magna. Additionally, the Company will pay Magna certain royalty fees until 2025.

 

The Company expects to file the License Agreement as an exhibit to its Annual Report on Form 10-K for the fiscal year ending June 30, 2018, and intends to seek confidential treatment for certain terms and provisions of the License Agreement. The foregoing description of the License Agreement is qualified in its entirety by reference to the text of the License Agreement, when filed.

 

Item 7.01Regulation FD Disclosure.

 

On June 13, 2018, the Company issued a press release announcing the License Agreement. A copy of the press release is attached as Exhibit 99.1 and incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in the press release attached as Exhibit 99.1 hereto shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01Financial Statements and Exhibits.

 

(d) The following exhibit is being filed herewith:

 

Exhibit   Description
99.1   Press Release dated June 13, 2018

 

 2 

 

 

SIGNATURE

 

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.

 

  AYTU BIOSCIENCE, INC.
   
Date: June 13, 2018 By:  /s/ David Green
    Name: David Green
    Title: Chief Financial Officer

 

 3 

Exhibit 99.1

 

Aytu BioScience Enters $1.8 Billion U.S. Prescription Sleep Aid Market with Exclusive License to Zolpimist™ to Expand Company’s Commercial-Stage Product Portfolio

 

Company acquires FDA-approved, commercial-stage product to complement Natesto® sales efforts among primary care physicians

 

ENGLEWOOD, CO, June 13, 2018 /ACCESSWIRE/ — Aytu BioScience, Inc. (NASDAQ: AYTU) (the “Company”), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, today announced that the Company has exclusively licensed Zolpimist™ (zolpidem tartrate oral spray) in the United States and Canada. Annual sales in the U.S. prescription sleep aid category were $1.8 billion over the 12-month period ending February 2018, approximately the same as the testosterone replacement prescription category.1 The Company believes that the addition of Zolpimist will complement ongoing Natesto selling efforts among primary care physicians and add another revenue-generating product to the Company’s portfolio.

 

Zolpimist is an FDA-approved, proprietary, oral spray formulation of zolpidem tartrate and is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Insomnia is the most common specific sleep disorder, with short-term sleep issues reported by about 30% of U.S. adults.

 

Josh Disbrow, Aytu BioScience’s Chief Executive Officer commented, “We continue to be pleased with the ongoing launch of Natesto in the U.S. via the Company’s direct sales force and the momentum we have achieved through our recently launched Natesto Support Program. We are now excited to add another approved product to our portfolio. Given the substantial overlap in prescribers of testosterone replacement therapies, and Natesto in particular, and anti-insomnia treatments, we believe that this acquisition enables the Company to efficiently expand its product portfolio and market both Natesto and Zolpimist to the primary care physicians we already call on. Our prescribers have embraced the novel nasal delivery of Natesto for the treatment of hypogonadism, and likewise, we believe that Zolpimist’s uniquely-delivered oral spray will present a unique, complementary clinical story in a similarly large, adjacent therapeutic category. We look forward to launching Zolpimist while continuing to drive adoption of Natesto in the U.S.”

 

For the twelve months ending February 2018, there were over 43 million prescriptions of non-benzodiazepine sleep aids written in the U.S., and zolpidem tartrate (brand name Ambien®) was the most commonly prescribed sleep aid. More than 30 million prescriptions of various forms of zolpidem tartrate are prescribed annually in the U.S.1

 

Zolpimist’s unique oral spray formulation enables high bioavailability via rapid absorption through the oral mucosa and no first-pass metabolism through the liver, resulting in a rapid onset of sleep.

 

The Company is planning to launch Zolpimist later this calendar year via its direct sales force, calling on the overlapping prescribers of both testosterone replacement therapies and insomnia treatments. Over 50% of current Natesto prescribers are primary care clinicians and significant prescribers of sleep aids, so the Company expects to synergize sales efforts by promoting two products to these same physician targets.

 

 

 

 

Mr. Disbrow continued, “We believe Zolpimist will serve a large need in insomnia, which affects up to 30% of Americans, while giving our sales representatives another novel product to sell to their primary care physicians. We thank licensor Magna Pharmaceuticals for selecting Aytu BioScience to commercialize Zolpimist and look forward to working with Magna as we build awareness and grow prescription demand for this important, novel product.”

 

Additional details of the exclusive licensing agreement are available via an 8-K that was filed with the Securities Exchange Commission on June 13, 2018.

 

1. Symphony Health PHAST Prescription Monthly. Non-Benzo Sleep Aid Class TRxs; Current 12 Months Ending February 2018.

 

About Aytu BioScience, Inc.

 

 Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. The Company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or "Low T"). Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k medical device clearance by the FDA. Aytu recently acquired exclusive U.S. rights to Zolpimist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu's strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large, growing markets. For more information visit aytubio.com. 

 

Cautionary Statement Regarding Forward Looking Statements

 

Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such forward-looking statements reflect the Company's expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include, but are not limited to, statements regarding our plans to commercialize Zolpimist, potential prescribers’ acceptance of Zolpimist, the effectiveness of Zolpimist in treating insomnia and any anticipated development related activities the Company anticipates undertaking using Zolpimist. When used herein, the words "anticipate," "believe," "estimate," "upcoming," "plan," "target", "intend" and "expect" and similar expressions, as they relate to Aytu BioScience, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company's actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement and our SEC filings. Please see the risks and uncertainties detailed in the “Forward-Looking Statements” and “Risk Factors” sections of our Annual Report on Form 10-K for the year ended June 30, 2017, and in other documents and reports we file from time to time with the SEC.

 

For more information:  
   
James Carbonara  
Hayden IR  
(646)-755-7412  
[email protected]  

 

 

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