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): January 11, 2021

 

 

 

NEOS THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

(State or other jurisdiction of incorporation)

 

001-37508   27-0395455
(Commission File No.)   (IRS Employer Identification No.)

 

 

 

 

2940 N. Highway 360

Grand Prairie, TX 75050

(Address of principal executive offices and zip code)

 

Registrant’s telephone number, including area code: (972) 408-1300

 

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:

xWritten 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(s)   Name of each exchange on which registered
Common stock, par value $0.001 per share   NEOS   The Nasdaq Stock Market LLC

 

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 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 7.01.    Regulation FD Disclosure.

 

On January 11, 2020, Neos Therapeutics, Inc. (“Neos”) made a presentation to current and prospective investors to discuss its business, including the proposed merger transaction pursuant to the terms of the Agreement and Plan of Merger, dated as of December 10, 2020, by and among Neos, Aytu Bioscience, Inc. (“Aytu”), and Neutron Acquisition Sub, Inc. (the “Merger Agreement”). A copy of the presentation and the portion of the script related to the proposed merger transaction are attached to this Current Report on Form 8-K as Exhibits 99.1 and 99.2 respectively.

  

In accordance with General Instruction B.2. of Form 8-K, the information contained in Item 7.01 and the exhibits attached hereto, 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, nor shall it 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 a filing.

 

Additional Information about the Proposed Merger Transaction and Where to Find It

 

This communication discusses the proposed merger transaction pursuant to the terms of the Merger Agreement. In connection with the proposed merger transaction, Aytu is expected to file with the United States Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 that will include a joint proxy statement of Aytu and Neos that also constitutes a prospectus of Aytu, which joint proxy statement/prospectus will be mailed or otherwise disseminated to Aytu stockholders and Neos stockholders when it becomes available. Aytu and Neos also plan to file other relevant documents with the SEC regarding the proposed merger transaction.

 

INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER TRANSACTION.

 

You may obtain a free copy of the joint proxy statement/prospectus and other relevant documents (if and when they become available) filed by Aytu or Neos with the SEC at the SEC’s website at www.sec.gov. Copies of the documents filed by Aytu with the SEC will be available free of charge on Aytu’s website at www.aytubio.com or by contacting Aytu’s Investor Relations at james@haydenir.com. Copies of the documents filed by Neos with the SEC will be available free of charge on Neos’ website at www. investors.neostx.com or by contacting Neos’ Investor Relations at (972) 408-1300.

 

Certain Information Regarding Participants

 

Neos and Aytu and their respective directors, executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed merger transaction. You can find information about Neos’ executive officers and directors in Neos’ definitive proxy statement filed with the SEC on April 21, 2020 in connection with Neos’ 2020 annual meeting of stockholders. You can find information about Aytu’s executive officers and directors in Aytu’s definitive proxy statement filed with the SEC on March 4, 2020 in connection with Aytu’s 2020 annual meeting of stockholders. Additional information regarding the interests of such potential participants will be included in the joint proxy statement/prospectus and other relevant documents filed with the SEC if and when they become available. You may obtain free copies of these documents from Neos or Aytu using the sources indicated above.

 

No Offer or Solicitation

 

This communication does not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor a solicitation of any vote or approval with respect to the proposed merger transaction or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”) and otherwise in accordance with applicable law.

 

2 

 

 

Cautionary Statement Regarding Forward-Looking Statements

 

This communication and other related materials contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including, but not limited to, statements concerning: the expected timetable for completing the proposed merger transaction, the results, effects, benefits and synergies of the proposed merger transaction, future, opportunities for the combined company, future financial performance and condition, the executive and board structure of Aytu; the ability of Neos to successfully commercialize Adzenys XR-ODT®, Cotempla XR-ODT®, Adzenys ER® (the “Approved ADHD Products”) and its generic Tussionex®; its ability to successfully advance its pipeline of product candidates, including licensed product candidates; its ability to maintain and protect its intellectual property; the outcome or success of its clinical trials; the rate and degree of market acceptance of its products; and its ability to develop sales and marketing capabilities. In some cases, you can identify forward-looking statements by terms such as “may,” ”will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements of this communication are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation, (i) the outcome of any legal proceedings that may be instituted against the companies related to the proposed merger transaction; (ii) unanticipated difficulties or expenditures relating to the proposed merger transaction, the response of business partners and competitors to the announcement of the proposed merger transaction, and/or potential difficulties in employee retention as a result of the announcement and pendency of the proposed merger transaction; (iii) risks associated with the companies’ ability to obtain the stockholder approvals required to consummate the proposed merger transaction and the timing of the closing of the proposed merger transaction, including the risks that a condition to closing would not be satisfied within the expected timeframe or at all or that the closing of the proposed merger transaction will not occur; (iv) the impact of COVID-19 on prescriptions for the Neos’ products and on its business, revenues, results of operations and financial condition; (v) Neos’ commercialization strategy for the Approved ADHD Products and other products that may be approved; (vi) the timing of any such approval; (vii) Neos’ ability to market and sell the Approved ADHD Products and any other products that may be approved; (viii) Neos’ ability to successfully compete in the market for medications indicated for ADHD; (ix) the manufacture of the Approved ADHD Products or Neos’ other product candidates; (x) the therapeutic potential of the Approved ADHD Products or Neos’ other product candidates; (xi) our ability to initiate and complete trials for NT0502; and (xii) other risks set forth under the caption “Risk Factors” in Neos’ most recent Annual Report on Form 10-K, as updated by Neos’ most recent Quarterly Report on Form 10-Q, and its other SEC filings. Moreover, Neos operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for Neos management to predict all risks, nor can Neos assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this communication may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Neos believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Neos nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Forward-looking statements in this communication represent Neos’ views only as of the date of this communication. Neos undertakes no obligation to update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

 

Item 9.01.            Financial Statements and Exhibits.

 

(d)              Exhibits

 

3 

 

 

Exhibit    
Number Description  
     
99.1 Investor Presentation dated January 11, 2021  
99.2 Investor Presentation Script  
104 Cover page Interactive Data File (embedded within the Inline XBRL document)  

 

4 

 

 

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.

 

  NEOS THERAPEUTICS, INC.
     
     
Date: January 11, 2021 By: /s/ Richard I. Eisenstadt
    Richard I. Eisenstadt
    Chief Financial Officer

 

5 

 

 

 

Exhibit 99.1

 

Corporate Presentation January 2021

 

Neos Therapeutics I January 2021 Additional Information about the Proposed Merger Transaction This presentation discusses the proposed merger transaction pursuant to the terms of the Agreement and Plan of Merger, dated as of December 10, 2020, by and among Neos Therapeutics, Inc. (“Neos”), Aytu Bioscience Inc. (“ Aytu ”), and Neutron Acquisition Sub, Inc. In connection with the proposed merger transaction, Aytu is expected to file with the United States Securities and Exchange Commission (the “SEC”) a registration statement on Form S - 4 that will include a joint proxy statement of Aytu and Neos that also constitutes a prospectus of Aytu , which joint proxy statement/prospectus will be mailed or otherwise disseminated to Aytu stockholders and Neos stockholders when it becomes available. Aytu and Neos also plan to file other relevant documents with the SEC regarding the proposed merger transaction. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THE Y BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER TRANSACTION. You may obtain a free copy of the joint proxy statement/prospectus and other relevant documents (if and when they become avai lab le) filed by Aytu or Neos with the SEC at the SEC’s website at www.sec.gov. Copies of the documents filed by Aytu with the SEC will be available free of charge on Aytu’s website at www.aytubio.com or by contacting Aytu’s Investor Relations at james@haydenir.com. Copies of the documents filed by Neos with the SEC will be available free of charge on Neos’ website at www. investors.neostx.com or by contacting Neos’ Investor Relations at (972) 408 - 1300. Certain Information Regarding Participants Neos and Aytu and their respective directors, executive officers and other members of management and employees may be deemed to be particip an ts in the solicitation of proxies in respect of the proposed merger transaction. You can find information about Neos’ executive officer s a nd directors in Neos’ definitive proxy statement filed with the SEC on April 21, 2020 in connection with Neos’ 2020 annual meeting of stockholders. You can fi nd information about Aytu’s executive officers and directors in Aytu’s definitive proxy statement filed with the SEC on March 4, 2020 in connection with Aytu’s 2020 annual meeting of stockholders. Additional information regarding the interests of such potential participants will be included in the joint pro xy statement/prospectus and other relevant documents filed with the SEC if and when they become available. You may obtain free copies of these documents from N eos or Aytu using the sources indicated above. No Offer or Solicitation This presentation does not constitute an offer to sell, or the solicitation of an offer to buy, any securities, nor a solicit ati on of any vote or approval with respect to the proposed merger transaction or otherwise. No offering of securities shall be made except by means of a prospectus meet ing the requirements of Section 10 of the Securities Act of 1933, as amended (the “Securities Act”) and otherwise in accordance with applicable law. 2

 

Neos Therapeutics I January 2021 Forward - Looking Statements This presentation and other related materials contain forward - looking statements within the meaning of the Private Securities Li tigation Reform Act of 1995 and other federal securities laws, including, but not limited to, statements concerning: the expected timetable for completing the prop ose d merger transaction, the results, effects, benefits and synergies of the proposed merger transaction, future, opportunities for the combined company, future fi nan cial performance and condition, the executive and board structure of with Aytu ; the ability of Neos to successfully commercialize Adzenys XR - ODT®, Cotempla XR - ODT®, Adzenys ER® (the “Approved ADHD Products”) and its generic Tussionex®; its ability to successfully advance its pipeline of product candidates, including li censed product candidates; its ability to maintain and protect its intellectual property; the outcome or success of its clinical trials; the rate and degree of market acc eptance of its products; and its ability to develop sales and marketing capabilities. In some cases, you can identify forward - looking statements by terms such as “may,” ”w ill,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “contin ue” or the negative of these terms or other similar expressions. The forward - looking statements of this presentation are only predictions and are subject to a number of ris ks, uncertainties and assumptions, including, without limitation, ( i ) the outcome of any legal proceedings that may be instituted against the companies related to the proposed merger transaction; (ii) unanticipated difficulties or expenditures relating to the proposed merger transaction, the response of business partners a nd competitors to the announcement of the proposed merger transaction, and/or potential difficulties in employee retention as a result of the announcement and pend enc y of the proposed merger transaction; (iii) risks associated with the companies’ ability to obtain the stockholder approvals required to consummate th e p roposed merger transaction and the timing of the closing of the proposed merger transaction, including the risks that a condition to closing would not be satisf ied within the expected timeframe or at all or that the closing of the proposed merger transaction will not occur; (iv) the impact of COVID - 19 on prescriptions for the Neos ’ products and on its business, revenues, results of operations and financial condition; (v) Neos’ commercialization strategy for the Approved ADHD Products and other products that may be approved; (vi) the timing of any such approval; (vii) Neos’ ability to market and sell the Approved ADHD Products and any oth er products that may be approved; (viii) Neos’ ability to successfully compete in the market for medications indicated for ADHD; (ix) the manufacture of the Approved ADH D Products or Neos’ other product candidates; (x) the therapeutic potential of the Approved ADHD Products or Neos’ other product candidates; (xi) our ability t o i nitiate and complete trials for NT0502; and (xii) other risks set forth under the caption “Risk Factors” in Neos’ most recent Annual Report on Form 10 - K, as updated by Neos’ most recent Quarterly Report on Form 10 - Q, and its other SEC filings. Moreover, Neos operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for Neos management to predict all risks, nor can Neos assess the impact of all factors on its business or the exten t t o which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward - looking statements it may make. In li ght of these risks, uncertainties and assumptions, the forward - looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward - looking statements. You should not rely upon forward - looking statements as predictio ns of future events. Although Neos believes that the expectations reflected in the forward - looking statements are reasonable, it cannot guarantee that the future r esults, levels of activity, performance or events and circumstances reflected in the forward - looking statements will be achieved or occur. Moreover, except as required by law, neither Neos nor any other person assumes responsibility for the accuracy and completeness of the forward - looking statements. Forward - looking statements in this presentation represent Neos’ views only as of the date of this presentation. Neos undertakes no obligation to update or review any forward - looking statement, whether as a result of new information, future developments or otherwise, except as required by law. This presentation may contain trade names, trademar ks or service marks of other companies. Neos does not intend the use or display of other parties’ trade names, trademarks or service marks to imply a rela tio nship with, or endorsement or sponsorship of, these other parties. Solely for convenience, the trade names, trademarks or service marks in this presentatio n a re referred to without the symbols ® and ™, but such references should not be construed as any indicator that their respective owners will not assert, to the full est extent under applicable law, their rights thereto. 3

 

Neos Therapeutics and AYTU Definitive Merger Agreement: Transaction Highlights & Strategic Rationale x Transaction creates highly diversified specialty pharmaceutical company with $100M of pro forma net revenue (1) ‒ Brand Marketing (10 products), Pediatric, Primary Care, and Consumer Healthcare products x Accelerates transformation to profitability with estimated annual cost synergies of approximately $15M by 2022 x Adds Aytu pediatric and primary care products to Neos established, high - performing, multi - brand ADHD portfolio, expanding footprint in pediatrics and adjacent specialty areas x Opportunity to leverage and further enhance Neos RxConnect , a best - in - class patient support program, for Aytu’s product portfolio of clinically differentiated prescription therapeutics x Broad pipeline platform anchored by lead product candidate for sialorrhea and novel microparticle technology technology delivery platform x Company well - positioned for continued growth through business development 4 (1) For the 12 - month period ended September 30, 2020. Neos Therapeutics I January 2021

 

Transaction Overview 5 Key Terms • Stock - for - stock transaction • Each holder of Neos shares will receive 0.1088 shares of common stock of Aytu per each share of Neos common stock held (subject to adjustment for any drawdowns on a bridge note provided by Aytu ), reflecting a 1:10 reverse stock split effected 12/9/20 (1) • Aytu will prepay $15M of Deerfield debt at closing and the final $15M payment will remain due at maturity (May 2022) Pro Forma Combined Company Financial Information • After giving effect to Aytu’s December 2020 public offering, Neos stockholders would own approximately 23% of the fully diluted common shares of the combined company • For the 12 - month period ended September 30, 2020, aggregate pro forma net revenues of over $100 million Board of Directors • Full Board of Directors to consist of 8 members • 6 Directors from Aytu ; 2 Directors from Neos Management • Management team drawn from both companies • Josh Disbrow to remain CEO of combined company Transaction Close • Expected to close by the second quarter of 2021 • Pending approval of Aytu and Neos stockholders and subject to satisfaction of customary closing conditions Equity • Combined company will continue to trade under NASDAQ: AYTU (1) Announced and effective on December 8, 2020. Neos Therapeutics I January 2021

 

AYTU’s Assertive M&A Has Created Platform to Drive Growth and Support Acquisitions 6 Unique opportunity to acquire assets as a consolidator in a market ripe for integration Entered Pediatric Specialty Pharmaceutical Market Diversified into Consumer Health with Purchase of ~$30M Portfolio Expansion of Pediatric Footprint and Scale to $100M in Pro Forma Revenue Acquired Pediatric Rx Portfolio from Cerecor Closed 11/2019 Acquired Innovus Pharmaceuticals Closed 2/2020 Planned Acquisition of Neos Therapeutics (NASDAQ: NEOS) Announced 12/2020* *Announced 12/10/20; Pending S - 4 filing and stockholder votes of both Aytu BioScience and Neos and customary closing conditions Neos Therapeutics I January 2021

 

The Combined Company will Result in a Highly Diversified Specialty Pharmaceuticals Platform with $100 Million in Pro Forma Net Revenue (1) 7 (1) For the 12 - month period ended September 30, 2020. Pediatrics Primary Care Consumer Health Three Complementary Product Sets with Critical Mass in Pediatrics Neos Therapeutics I January 2021

 

vision We are focused on significantly improving daily living for patients by expanding and improving access to Neos medications 8

 

Neos Therapeutics I January 2021 Neos Today: Remain Focused on Driving Growth 9 Focused on maximizing the cash generated from the ADHD portfolio Facilitating access to Neos medicines through Neos RxConnect • Scalable beyond ADHD portfolio Leveraging Neos ’ advanced analytics platform and commercial organization Established, Multi - Brand ADHD Portfolio New Product Opportunities NT0502 in Phase 1 clinical development for treatment of chronic sialorrhea (excessive drooling) • Significant unmet need among 1.4M patients in U.S. for an effective therapy with an improved tolerability profile and dosing regimen Leverage commercial model with additional product opportunities

 

Neos Therapeutics I January 2021 2020 Financial Overview NET PRODUCT SALES Q3 2020 Adzenys XR - ODT $6.2M Cotempla XR - ODT $5.6M Adzenys ER * Generic Tussionex $0.7M $12.5M Fiscal Quarter Ended September 30, 2020 (in 000s) Net Product Sales $12,535 Gross Profit $7,415 Loss from Operations ($2,916) Weighted Average Shares 49,755 Cash, Cash Equivalents & ST Investments $12,744 • As of September 30, 2020, the Company had $34.4M in principal debt outstanding with Deerfield and $ 7.3 M outstanding under a senior secured revolving credit agreement . 10 * Adzenys ER revenue was negligible in the 3Q of 2020.

 

ADHD Product Portfolio

 

Large and Growing ADHD Market Drug Type Annual Prescriptions 1 (Million) Annual Gross Revenue 4 (Billion) Amphetamine 48.5 $5.6 Methylphenidate 19.6 $2.6 Non - Stimulants 6.9 $0.3 Total 75.1 $8.8 ▪ 75.1 million prescriptions written annually for ADHD medications 1 ▪ Estimated to affect 11.0% of children ages 4 - 17 2 and 4.4% of adults in the U.S. 3 ▪ ADHD prescriptions grew by 4.2% in recent 12 months 1 1. IQVIA: National Prescription Audit – trailing 12 month data as of December 2019 2. 2011 - 2012 National Survey of Children’s Health (US - DHHS) http://www.cdc.gov/nchs/slaits/nsch.htm . Accessed March 19, 2015. 3. Brus ML, et al. J. Psychiatr Pract . 2014; (6):428 - 37. 4. IQVIA; National Sales Perspective – trailing 12 month data as of December 2019 12 Neos Therapeutics I January 2021

 

Approved for patients 6+ years, both pediatric and adult Focused on adults – the fastest growing segment of the market Approved for patients ages 6 - 17 Compelling clinical efficacy data demonstrating symptom control at 1 hour after dosing and sustained through 12 hours Our ADHD Products – The Difference is in the Delivery 13 Neos Therapeutics I January 2021

 

150,000 170,000 190,000 210,000 230,000 250,000 270,000 290,000 310,000 MPH Market Comparison 2019 Vs 2020 MPH 2019 MPH 2020 ADHD TRx Market Rebounding from 1H2020 COVID - 19 Impact ▪ Extended - release ADHD TRx’s in 2020 vs. same weeks in 2019 1 ( - 2.4%): • Methylphenidate (MPH) market - 6.5% • Amphetamine (AMP) market essentially flat ▪ Pediatric segment - 10.7% vs 2019 2 1 Source: IQVIA Rapid Weekly Summary report. W/E 12/4/20 2 Source: IQVIA NPA+Patient Insights current 8 weeks ending 11/27/20 300,000 350,000 400,000 450,000 500,000 550,000 600,000 AMP Market Comparison 2019 Vs 2020 AMP 2019 AMP 2020 Neos Therapeutics I January 2021 14

 

19.0% 17.2% 21.7% 8.9% 8.0% 14.7% 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% Neos Portfolio/ Market Adzenys XR ODT/AMP Cotempla XR ODT/MPH Neos TRx vs Branded Market 2 TRx 3Mo vs 3Mo Neos Branded Market Recent ADHD Brand TRx Performance Neos Brands Outpaced Market During 2020 Back - to - School Season ▪ Neos portfolio outperforming the market during BTS 1 • 3 - month portfolio TRx growth: o +19% (~ 2x market growth) • Both products have shown growth rates exceeding market 1 Source: IQVIA NPA ; May – July 2020 vs Aug – Oct 2020 2 Source: Branded Market include: AMP Dyanavel , Evekeo , Mydayis , Vyvanse; MPH Adhansia , Daytrana , Jornay , Quillichew , Quillivant Neos Therapeutics I January 2021 15

 

Neos RxConnect Addresses Key Barriers to Patient Care ▪ Offers predictability and enhances access to Neos brands for 100% of commercially insured patients, regardless of individual insurance coverage • Allows prescribers to focus on best therapeutic option, rather than on individual insurance coverage ▪ Reduces prescriber hassles that they may face when prescribing branded medications for their patients • No prior authorizations required to access Neos brands • Potentially reduces office administrative burden ▪ Affordable for all commercially insured patients • Even when enrolled in high - deductible plans 16 Neos Therapeutics I January 2021

 

Neos RxConnect Positioned to Support Growth of Neos ADHD Brands ▪ Neos RxConnect network growth outpaced retail growth by 17% during Q3 2020 1 • Exceeded 26k claims during Q3 2020 which was an all - time quarterly high ▪ Sound foundation and footprint • 900+ locations • 100% territory coverage ▪ Strategic growth driver for 2021 • Build greater awareness and utilization amongst key ADHD prescribers • Increase current prescriber depth of prescribing and expand prescriber breadth of utilization Unlocking future patient access growth opportunities and Neos brand adoption Source: 1 ConnectiveRx claims. Q2 2020 vs Q3 2020 Neos Therapeutics I January 2021 17

 

Development Pipeline

 

Sialorrhea: Prevalent and Excessive Drooling of Saliva Significant Burden for Many Patients Across a Variety of Neurological Disorders Source: Mozaffarian. AHA Circulation. 2016; Taylor. MMWR Surveill Summ. 2017; Laskowitz. CRC Press; 2016; Alhashemi. Neurosci enc es (Riyadh). 2010; Cohen. Int J Stroke. 2016; Maenner. Ann Epidemiol 2016; Marras. NPJ Parkinsons Dis. 2018; Kalf. J Neurol. 200 9; Reid. Dev Med Child Neurol. 2012; McGrath Epidemiol Rev. 2008; 2015 Clozapine for Treating Schizophrenia – A comparison of the States; Mah er. Ther Adv Psychopharmacol. 2016; Garnock - Jones. Paediatric Drugs 2012; Lakraj. Toxins 2013; Physician Interviews. Prevalence Est. Affected Patients Current Therapies Approximately 1.4 M diagnosed patients with sialorrhea in U.S. alone Non - selective Anticholinergics and Botulinum Toxins are reserved for the most severe patients but are associated with considerable side effects and tolerability concerns Parkinson’s Disease Cerebral Palsy Stroke/TBI Other 0.4 M 0.3 M 0.6 M 0.1 M Chronic sialorrhea represents a significant disease burden for patients, many of whom remain untreated due to limitations associated with current therapies 19 Neos Therapeutics I January 2021

 

NT0502: Developing a Potential New Treatment Option Aiming to Meet the Needs of Patients with Sialorrhea Selective Pharmacological Profile Based on Preclinical Data ▪ NT0502 is a new chemical entity and anticholinergic agent that is preferentially selective for blocking muscarinic receptor subtypes predominant in salivary glands Potential for Fewer Systemic Side Effects Compared to Existing Treatment Options ▪ A targeted therapy may provide improved tolerability which is important when treating complex neurologic patients Phase 1 Clinical Development Plan ▪ Top - line pharmacokinetic data in pilot pharmacokinetic study supports further clinical development ▪ Planned initiation of Phase 1 single ascending and multiple ascending dose studies (SAD/MAD) Patent Protection Through 2032 ▪ Issued patent in April 2020 directed to methods of treating sialorrhea by administering N - desethyloxybutynin 20 Neos Therapeutics I January 2021

 

Key Takeaways

 

Neos Therapeutics I January 2021 Key Takeaways Recent Highlights x Announced definitive merger agreement with Aytu in December 2020 x Neos RxConnect surpassed 900 pharmacies and accounted for 40% of Neos ADHD TRx’s in 3Q 2020 x Neos brands sequential growth in 3Q 2020 for Adzenys XR - ODT (+9.9%) and Cotempla XR - ODT (+6.5%) outperformed the overall market (+4.1%) 22 Near - term Goals ▪ Capitalize on ADHD market recovery and current Neos ADHD prescription momentum ▪ Build greater awareness and utilization of Neos RxConnect amongst key ADHD prescribers ▪ Close merger with AYTU by 2Q 2021

 

Corporate Presentation January 2021

 

 

Exhibit 99.2 

 

Gerald McLaughlin (Chief Executive Officer of Neos Therapeutics, Inc.) 

 

Slide 4

 

Thanks for accessing the presentation today. This is, indeed, an exciting time in the history of Neos Therapeutics as on December 10, 2020, we entered into a definitive merger agreement with AYTU in an all-stock transaction. The Board of Directors of Neos believes that this merger represents the highest-potential value creation opportunity for Neos stockholders, and we are pleased to be joining forces with AYTU to create a stronger specialty pharmaceutical company.

Before getting into the details of the transaction along with the deal rationale and more, I firmly believe Aytu is the right partner to continue the exceptional work our team at Neos has done to build the ADHD franchise into what it is today and to continue the development of NT0502 for the treatment of sialorrhea. By leveraging the respective commercial infrastructure of Neos and Aytu, including complementary sales call points and our best-in-class patient support program, Neos RxConnect, we expect continued growth of the product portfolio over the long-term.

On this slide, I’ve detailed some of the key strategic reasons for this transaction and wanted to take a moment to discuss a few:

 

1) With this merger, we will be creating a combined $100 million plus annual revenue, highly diversified, specialty pharmaceutical company with a strong pediatric footprint and a great deal of momentum. This is a transformational transaction for both companies, and, upon closing, immediately scales revenue to nearly double the current 2020 run rate for Neos.

 

2) The transaction will not only dramatically increase revenue, but will also enable the scale and operational efficiencies that were difficult to achieve as a stand-alone entity, including an estimated $15 million of annualized cost synergies by 2022, all while continuing to drive revenue growth.

 

3) With the addition of the Neos ADHD franchise, the merger will deepen and broaden Aytu’s already strong presence in pediatrics, while expanding the footprint into adjacent specialty areas including psychiatry. We are confident that the Neos ADHD portfolio has a long exclusivity runway to continue to grow and contribute significant revenue based upon the value offered to patients in the large and growing ADHD market.


4) Also, we expect that Neos RxConnect, our best-in-class patient support program that has reached scale in terms of pharmacies, will not only continue to be a growth driver for the ADHD brands but can be leveraged for Aytu’s broad portfolio of clinically differentiated products.


5) Finally, this new company will be well-positioned for continued growth through strategic transactions. Aytu has a demonstrated track record and ability to identify and execute business development opportunities and we fully expect this to continue in the future.

 

In short, the rationale for this transaction is sound, and we couldn’t be more excited about the future of this combined entity for our stockholders.

 

Slide 5

 

Now I’ll move on to the details of the merger:

 

 

 

 

This is an all-stock transaction whereby Neos stockholders will be entitled to receive 0.1088 shares of Aytu common stock for each share of Neos common stock held

 

Aytu will prepay $15 million of the outstanding Neos debt payment due to Deerfield in May 2021 and the remaining $15 million will remain and will be due in May 2022. Following Aytu’s December 2020 equity offering, the transaction will result in Neos stockholders owning approximately 23% of the fully diluted common shares of the combined Company. The boards of directors of both companies have approved the transaction and will recommend approval by the companies’ respective shareholders.

 

The company will be led by Josh Disbrow, current Aytu CEO, and will be headquartered in Englewood, Colorado with management comprised of individuals from both companies. The board of the combined company will consist of six members designated by Aytu and two members designated by Neos. Along with current Neos board member Beth Hecht, I will join the Aytu board upon closing of the transaction, which is expected by the second quarter of this year. Both Beth and I look forward to serving and supporting the efforts of Josh and the team to create long-term value for stockholders.

 

Slide 6

 

As previously mentioned, Aytu is executing on their vison to create a leading specialty pharmaceutical company. In a little over a year, they have completed and now announced three major deals, and with this foundation the company will be well-positioned for continued growth through additional strategic transactions. The Aytu leadership team has a well-thought plan combined with the experience and skills to execute deals. The combination of Aytu and Neos only provides a greater opportunity and stronger platform for subsequent acquisitions, which was an important consideration for Neos as we evaluated our strategic alternatives.

 

Slide 7

 

As we drill down on the revenue base of the combined company, we see three complementary sets of products with a strong focus – and importantly critical mass – in pediatrics. Neos currently fields a sales force calling on high prescribers of ADHD medications and has full commercial support functionality, as does Aytu. By combining our respective sales forces, the new Aytu will continue to promote the Neos ADHD brands while also promoting core heritage Aytu brands – with a focus on Poly-Vi-Flor, Karbinal, Natesto, ZolpiMist, and Tuzistra XR.

 

We are confident the combined company also can leverage the Neos RxConnect program, our established and proven best-in-class patient access program that can be extended to Aytu’s prescription products and, we believe, some of Aytu’s consumer health products as well. We see significant synergies here and opportunities to drive the business forward.

 

We believe that Aytu is the right partner for Neos. With the shared strength of our companies, I believe we can more rapidly grow the ADHD product line, realize the value of Neos RxConnect, and leverage the benefits of combining the two companies’ salesforces, overlapping sales call points and commercial infrastructure, thus enhancing value to the Neos and Aytu stockholders for the long term.

 

 

 

 

Slide 23

 

In closing, we believe that the combination of Neos and Aytu will enable strong value creation for stockholders and employees with the opportunity to serve many, many more health care professionals and patients.

 

The merger is currently expected to close by the second quarter of this year, subject to approval by each company’s respective stockholders and the satisfaction of other customary closing conditions. We are working expeditiously to file the necessary documents with the SEC and, once cleared, will schedule our respective stockholder meetings.

 

Thank you. We look forward to providing additional updates over the coming weeks and months.