NEOS Neos Therapeutics Inc.

0.69
-0.01  -1%
Previous Close 0.7
Open 0.69
52 Week Low 0.6
52 Week High 2.15
Market Cap $34,293,602
Shares 49,751,345
Float 49,220,717
Enterprise Value $60,125,687
Volume 151,036
Av. Daily Volume 182,247
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Drug Pipeline

Drug Stage Notes
NT0502
Sialorrhea
Phase 1
Phase 1
Phase 1 ascending dose trial initiation planned in 2H 2020.
Cotempla XR-ODT
Attention deficit hyperactivity disorder (ADHD)
Approved
Approved
Approval announced June 19, 2017.
Adzenys XR-ODT
Attention deficit hyperactivity disorder (ADHD)
Approved
Approved
Approved January 27, 2016.
NT-0201
Attention deficit hyperactivity disorder (ADHD)
Approved
Approved
Approval announced September 15, 2017.

Latest News

  1. DALLAS and FORT WORTH, Texas, June 16, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that Jerry McLaughlin, President and Chief Executive Officer, will present a company overview at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020, at 4:30 p.m. ET.

    A live webcast of the presentation will be available on the Investor Relations page of the company's website at http://investors.neostx.com/. Following the presentation, a replay of the webcast will be available on Neos' website for 30 days. 

    About Neos Therapeutics
    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage…

    DALLAS and FORT WORTH, Texas, June 16, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that Jerry McLaughlin, President and Chief Executive Officer, will present a company overview at the BMO 2020 Prescriptions for Success Healthcare Conference on Tuesday, June 23, 2020, at 4:30 p.m. ET.

    A live webcast of the presentation will be available on the Investor Relations page of the company's website at http://investors.neostx.com/. Following the presentation, a replay of the webcast will be available on Neos' website for 30 days. 

    About Neos Therapeutics

    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage pharmaceutical company developing and manufacturing central nervous system (CNS)-focused products. The Company markets Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD. The Company also has a development candidate, NT0502, for the treatment of sialorrhea in patients with neurological conditions. Additional information about Neos is available at www.neostx.com.

    CONTACTS:

    Richard I. Eisenstadt

    Chief Financial Officer

    Neos Therapeutics

    (972) 408-1389

    Sarah McCabe

    Investor Relations

    Stern Investor Relations, Inc.

    (212) 362-1200

    Primary Logo

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  2. DALLAS and FORT WORTH, Texas, May 26, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that Jerry McLaughlin, President and Chief Executive Officer, will present a company overview at the upcoming Jefferies Virtual Global Healthcare Conference on Tuesday, June 2, 2020, at 9:00 a.m. ET.

    A live webcast of the presentation will be available on the Investor Relations page of the company's website at http://investors.neostx.com/. Following the presentation, a replay of the webcast will be available on Neos' website for 30 days. 

    About Neos Therapeutics
    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage…

    DALLAS and FORT WORTH, Texas, May 26, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that Jerry McLaughlin, President and Chief Executive Officer, will present a company overview at the upcoming Jefferies Virtual Global Healthcare Conference on Tuesday, June 2, 2020, at 9:00 a.m. ET.

    A live webcast of the presentation will be available on the Investor Relations page of the company's website at http://investors.neostx.com/. Following the presentation, a replay of the webcast will be available on Neos' website for 30 days. 

    About Neos Therapeutics
    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage pharmaceutical company developing and manufacturing central nervous system (CNS)-focused products. The Company markets Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD. The Company also has a development candidate, NT0502, for the treatment of sialorrhea in patients with neurological conditions. Additional information about Neos is available at www.neostx.com.

    CONTACTS:

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389

    Sarah McCabe
    Investor Relations
    Stern Investor Relations, Inc.
    (212) 362-1200

    Primary Logo

    View Full Article Hide Full Article
  3. – Company announces reduction in force to streamline costs and accelerate the path to profitability, particularly in light of the business impact from the COVID-19 pandemic

    – Company to host conference call today at 5:00 p.m. EDT –

    DALLAS and FORT WORTH, Texas, May 11, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today reported financial results for the first quarter ended March 31, 2020 and announced that it is reducing its cost structure by decreasing its workforce by approximately 25 percent.

    "Since late 2018, we have been steadfast in taking action to better position Neos for long-term profitability and growth…

    – Company announces reduction in force to streamline costs and accelerate the path to profitability, particularly in light of the business impact from the COVID-19 pandemic

    – Company to host conference call today at 5:00 p.m. EDT –

    DALLAS and FORT WORTH, Texas, May 11, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today reported financial results for the first quarter ended March 31, 2020 and announced that it is reducing its cost structure by decreasing its workforce by approximately 25 percent.

    "Since late 2018, we have been steadfast in taking action to better position Neos for long-term profitability and growth. Today, we have made the difficult but necessary decision to reduce headcount across the organization to streamline costs and further strengthen our long-term outlook as we adjust to a rapidly changing economic environment and the recent impact on our business as a result of the COVID-19 pandemic. We believe this decision will ensure and accelerate our path to profitability, enable further investment in our pipeline candidate, NT0502, for the treatment of sialorrhea and strengthen our ability to acquire on-market product opportunities to leverage our commercial organization. We acknowledge this decision impacts many talented employees, and I would like to personally thank them for their contributions to Neos and their dedication to the patients we serve," said Jerry McLaughlin, President and Chief Executive Officer.

    The reduction in force announced today, affects approximately 50 employees, or 25 percent of the Company's workforce. Following these changes, the Company will have approximately 45 (of the previous 75) sales territories, which represent approximately 80 percent of its current prescriber base for its Attention Deficit Hyperactivity Disorder (ADHD) business. The Company plans to deploy alternative sales and marketing efforts toward many of the remaining 20 percent of current prescribers.

    ADHD Commercial Franchise

    • Increased net revenue per pack by over 21 percent year-over-year: Neos reported growth in net revenue per pack for its two core commercial ADHD products, Adzenys XR-ODT® and Cotempla XR-ODT®, for the three months ended March 31, 2020 compared to the same period in 2019. Blended net revenue per pack for the first quarter of 2020 was $128 compared to $106 for the first quarter of 2019, an increase of nearly 21 percent. These results reflect the continued execution of the Company's strategic shift in its ADHD business towards more profitable business channels and market segments.

    • Neos RxConnect patient support program continued to expand and is expected to reach 1,000 participating pharmacies in 2Q 2020: During the first quarter of 2020, the Company continued to substantially expand the number of participating pharmacies in the Neos RxConnect network. As of May 1, 2020, the network included approximately 800 pharmacies, compared to approximately 500 as of the end of 2019. In addition, the Company has come to an agreement with another large, regional grocery store chain that will increase the number of participating pharmacies to greater than 1,000 by the end of the second quarter of 2020. The Company believes the Neos RxConnect patient support program will continue to play an increasingly important role in the growth of the Company's ADHD business by providing affordable and predicable access to Neos ADHD medications to patients while eliminating many of the hassles that deter health care providers from prescribing medications that they consider most appropriate for their patients.   

    Development Pipeline

    • Announced issuance of new U.S. Methods of Use Patent for N-desethyloxybutynin: The Company announced in April 2020 that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 10,610,507, which is directed to methods of treating sialorrhea by administering N-desethyloxybutynin, the active pharmaceutical ingredient in NT0502. NT0502 is currently in clinical development for the treatment of sialorrhea in patients with neurological conditions. The patent, licensed to Neos Therapeutics, is not expected to expire before November 2032.

    • NT0502 Phase 1 single ascending and multiple ascending dose trial to begin in second half of 2020: The Company plans to initiate a Phase 1 clinical trial for NT0502, for the treatment of sialorrhea in patients with neurological conditions, in the second half of 2020. The multi-part study will include single ascending and multiple ascending dose cohorts.

    Financial Highlights and Select First Quarter 2020 Financial Results

    • For the first quarter of 2020, net loss was $8.0 million, compared to $7.6 million in the first quarter of 2019.

    • Total product revenues were $14.5 million for the three months ended March 31, 2020, compared to $14.6 million for the same period in 2019.
      Q1 2020 Q1 2019
    Adzenys XR-ODT $4.2MM $6.7MM
    Cotempla XR-ODT $8.1MM $5.8MM
    Adzenys ER $0.2MM $0.1MM
    Generic Tussionex $2.0MM $2.0MM
      Total $14.5MM $14.6MM
    • Gross profit was $8.1 million for the three months ended March 31, 2020, compared to a gross profit of $8.2 million for the same period in 2019.
       
    • Research and development expenses were $2.0 million for the three months ended March 31, 2020, compared to $3.2 million for the same period in 2019.
       
    • Selling and marketing expenses were $7.6 million for the three months ended March 31, 2020, compared to $7.1 million for the same period in 2019.
       
    • General and administrative expenses were $4.4 million for the three months ended March 31, 2020, compared to $3.8 million for the same period in 2019.
       
    • At March 31, 2020, the Company held $31.9 million in cash and cash equivalents and short-term investments.
       
    • On May 6, 2020 the Company announced that it had amended its debt facility with Deerfield to defer $5.0 million of the $15.0 million of principal due to Deerfield on May 11, 2020.  The Company will instead pay the $5.0 million over eight equal monthly installments beginning on September 11, 2020 and ending on April 11, 2021.

    Conference Call Details
    Neos management will host a conference call and live audio webcast to discuss these results and provide a company update at 5:00 p.m. EDT today. The live call may be accessed by dialing (877) 388-8985 for domestic calls, or +1 (562) 912-2654 for international callers, and referencing conference ID number 1099917. A live audio webcast for the conference call will be available on the Investor Relations page of the Company's website at http://investors.neostx.com/. Following the conclusion of the call, the webcast will be available for replay for 30 days.

    About Neos Therapeutics
    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage pharmaceutical company developing and manufacturing central nervous system (CNS)-focused products. The Company markets Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD. The Company also has a development candidate, NT0502, for the treatment of sialorrhea in patients with neurological conditions. Additional information about Neos is available at www.neostx.com.

    Forward-Looking Statements
    Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, commercial products, clinical development of its therapeutic candidates, plans for potential future product candidates, financial condition and outlook, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of COVID-19 on prescriptions for the Company's products and on the Company's business, revenues, results of operations and financial condition, the net sales, profitability, and growth of the Company's commercial products, the Company's future expansion of the Neos RxConnect network; the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials, including whether the Company will initiate a Phase 1 ascending dose study of NT0502 in the second half of 2020; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals; the financial condition and outlook for the Company, including whether the Company will continue to make progress towards its goal of achieving operational profitability; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property, including the expected expiration of the methods of use patent for N-desethyloxybutynin; other matters that could affect the availability or commercial potential of the Company's commercial products or therapeutic candidates; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.



    Neos Therapeutics, Inc. and Subsidiaries
    CONDENSED CONSOLIDATED BALANCE SHEETS
    (In thousands, except share and per share data)
    (unaudited)

      March 31,    December 31, 
      2020   2019
    ASSETS          
    Current Assets:          
    Cash and cash equivalents $  27,858     $  16,830  
    Short-term investments    3,992        8,064  
    Accounts receivable, net of allowances for chargebacks and cash discounts of $3,295 and $4,848 at March 31, 2020 and December 31, 2019, respectively    20,782        26,563  
    Inventories, net    10,218        11,010  
    Prepaid expenses and other current assets    2,904        4,092  
    Total current assets    65,754        66,559  
               
    Property and equipment, net    7,014        7,345  
    Operating lease right-of-use assets    2,920        3,044  
    Intangible assets, net    12,139        12,543  
    Other assets    1,266        1,382  
    Total assets $  89,093     $  90,873  
               
    LIABILITIES AND STOCKHOLDERS' DEFICIT          
               
    Current Liabilities:          
    Accounts payable $  13,033     $  6,650  
    Accrued expenses    30,556        40,188  
    Current portion of operating lease liabilities    707        681  
    Short-term line of credit    8,569        —  
    Current portion of long-term debt    15,534        15,836  
    Total current liabilities    68,399        63,355  
               
    Long-Term Liabilities:          
    Long-term debt, net of current portion    29,422        29,099  
    Operating lease liabilities    3,067        3,254  
    Derivative liability    1,231        1,135  
    Other long-term liabilities    154        160  
    Total long-term liabilities    33,874        33,648  
               
    Stockholders' (Deficit) Equity:          
    Preferred stock, $0.001 par value, 5,000,000 shares authorized, no shares issued or outstanding at March 31, 2020 and December 31, 2019    —        —  
    Common stock, $0.001 par value, 100,000,000 shares authorized at March 31, 2020 and December 31, 2019; 49,777,756 and 49,743,955 shares issued and outstanding, respectively, at March 31, 2020; 49,766,472 and 49,732,671 shares issued and outstanding, respectively, at December 31, 2019    50        50  
    Treasury stock, at cost, 33,801 shares at March 31, 2020 and December 31, 2019    (352 )      (352 )
    Additional paid-in capital    328,956        328,056  
    Accumulated deficit    (341,835 )      (333,885 )
    Accumulated other comprehensive income    1        1  
    Total stockholders' deficit    (13,180 )      (6,130 )
    Total liabilities and stockholders' deficit $  89,093     $  90,873  



    Neos Therapeutics, Inc. and Subsidiaries
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (In thousands, except share and per share data)
    (unaudited)

      Three Months Ended
      March 31, 
      2020   2019
    Revenues:          
    Net product sales $  14,493     $  14,634  
               
    Cost of goods sold    6,389        6,396  
    Gross profit    8,104        8,238  
               
    Research and development expenses    2,035        3,197  
    Selling and marketing expenses    7,592        7,069  
    General and administrative expenses    4,365        3,793  
               
    Loss from operations    (5,888 )      (5,821 )
               
    Interest expense    (2,037 )      (2,115 )
    Other (expense) income, net    (25 )      336  
               
    Net loss $  (7,950 )   $  (7,600 )
               
    Weighted average common shares outstanding used to compute net loss per share, basic and diluted    49,736,125        49,703,563  
               
    Net loss per share of common stock, basic and diluted $  (0.16 )   $  (0.15 )

     

    Contacts:

    Richard Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408‑1389

    Sarah McCabe
    Stern Investor Relations, Inc.
    (212) 362‑1200

    Primary Logo

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  4. DALLAS and FORT WORTH, Texas, May 04, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that it will report its first quarter 2020 financial results at the closing of U.S. financial markets on Monday, May 11, 2020. Neos management will host a conference call and live audio webcast to discuss these results and provide a company update at 5:00 p.m. ET that same day.

    The live call may be accessed by dialing (877) 388-8985 for domestic calls, or +1 (562) 912-2654 for international callers, and referencing conference ID number 1099917. A live audio webcast for the conference call will be available on the…

    DALLAS and FORT WORTH, Texas, May 04, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that it will report its first quarter 2020 financial results at the closing of U.S. financial markets on Monday, May 11, 2020. Neos management will host a conference call and live audio webcast to discuss these results and provide a company update at 5:00 p.m. ET that same day.

    The live call may be accessed by dialing (877) 388-8985 for domestic calls, or +1 (562) 912-2654 for international callers, and referencing conference ID number 1099917. A live audio webcast for the conference call will be available on the Investor Relations page of the company's website at http://investors.neostx.com/ and will be available for replay following the call for 30 days.

    About Neos Therapeutics
    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage pharmaceutical company utilizing its novel microparticle delivery technology to develop and manufacture central nervous system (CNS)-focused products. Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD, are three approved products utilizing the Company's novel microparticle delivery technology. Additional information about Neos is available at www.neostx.com.

    CONTACTS:

    Richard I. Eisenstadt
    Chief Financial Officer
    Neos Therapeutics
    (972) 408-1389

    Sarah McCabe
    Investor Relations
    Stern Investor Relations, Inc.
    (212) 362-1200

    Primary Logo

    View Full Article Hide Full Article
  5. DALLAS and FORT WORTH, Texas, April 09, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,610,507, which is directed to methods of treating sialorrhea by administering N-desethyloxybutynin, the active pharmaceutical ingredient in NT0502. NT0502 is currently in Phase 1 clinical development for the treatment of sialorrhea in patients with neurological conditions. The patent, assigned to Neos Therapeutics, is not expected to expire before November 2032.

    "We are very pleased to have secured this important method of use…

    DALLAS and FORT WORTH, Texas, April 09, 2020 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NASDAQ:NEOS), a commercial-stage pharmaceutical company developing and manufacturing central nervous system-focused products, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,610,507, which is directed to methods of treating sialorrhea by administering N-desethyloxybutynin, the active pharmaceutical ingredient in NT0502. NT0502 is currently in Phase 1 clinical development for the treatment of sialorrhea in patients with neurological conditions. The patent, assigned to Neos Therapeutics, is not expected to expire before November 2032.

    "We are very pleased to have secured this important method of use patent from the USPTO. The issuance of this patent further supports our efforts to explore the potential of NT0502 to treat sialorrhea in patients with neurological disorders, particularly Parkinson's Disease, given the significant psychosocial and medical impact they experience," said Jerry McLaughlin, President and Chief Executive Officer. "We remain on track to initiate a Phase 1 single ascending and multiple ascending dose clinical trial of NT0502 in the second half of 2020, and look forward to reporting the data from this trial."

    About NT0502
    NT0502 (N-desethyloxybutynin) is a new chemical entity being developed as an oral, once- or twice-daily treatment to reduce chronic sialorrhea in patients with neurological and other conditions associated with excess saliva and drooling. Based on preclinical data, the company believes that NT0502 offers the potential for an improved tolerability profile and an easier-to-dose oral formulation, without the need for complex titration, compared to existing treatment options. N-desethyloxybutynin is an active metabolite of oxybutynin, an approved drug to treat a urological condition.

    About Sialorrhea
    Sialorrhea is defined as prevalent and excessive drooling from the mouth as a result of limitations in a person's ability to control and swallow oral secretions1,2. Sialorrhea can lead to significant physical and psychosocial complications, including perioral chapping, aspiration, dehydration, infection, foul odor, stigmatization, and increased dependency and level of care, all of which can create an additional burden for these medically complicated patients1,3. In the U.S., more than 1.4 million patients – including those suffering from Parkinson's disease4,5, cerebral palsy6,7, stroke8,9, traumatic brain injury10, ALS11 and other neurological conditions12,13 – experience sialorrhea due to neuromuscular/sensory dysfunction. Many of these patients remain untreated today because existing non-selective anticholinergic agents are associated with treatment-limiting side effects and cumbersome dosing schedules.

    About Neos Therapeutics
    Neos Therapeutics, Inc. (NASDAQ:NEOS) is a commercial-stage pharmaceutical company utilizing its novel microparticle delivery technology to develop and manufacture central nervous system (CNS)-focused products. Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING), and Adzenys-ER® (amphetamine) extended-release oral suspension (see Full Prescribing Information, including Boxed WARNING), all for the treatment of ADHD, are three approved products utilizing the Company's novel microparticle delivery technology. Additional information about Neos is available at www.neostx.com.

    Forward-Looking Statements
    Certain statements in this press release constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve statements about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, commercial products, clinical development of its therapeutic candidates, plans for potential future product candidates, financial condition and outlook, intellectual property, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the impact of COVID-19, including with respect to the clinical development of NT0502; the status, timing, costs, results and interpretation of the Company's clinical trials or any future trials, including whether the Company will initiate a Phase 1 ascending dose study of NT0502 in the second half of 2020; the uncertainties inherent in conducting clinical trials, including any potential impact on timing resulting from COVID-19; expectations for regulatory interactions, submissions and approvals; the financial condition and outlook for the Company; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property, including with respect to the U.S. patent covering methods of treating sialorrhea; other matters that could affect the availability or commercial potential of the Company's commercial products or therapeutic candidates, including whether NT0502 offers the potential for an improved tolerability profile and an easier-to-dose oral formulation, without the need for complex titration, compared to existing treatment options; and other factors discussed in the Risk Factors set forth in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments may cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

    References

    1. Hockstein NG, et al. Sialorrhea: a management challenge. Am Fam Physician. 2004; 69: 2628-34.
    2. Chou KL, et al. Sialorrhea in Parkinson's Disease: a review. Movement Disorders. 2007; 22(16): 2306-2313.
    3. Bavikatte G, et al. Management of drooling of saliva. Br J Med Practitioners. 2012; 5(1): a507.
    4. Marras C, et al. Prevalence of Parkinson's disease across North America. npjParkinson's Disease. 2018; 4(21): 1-22.
    5. Kalf JG, et al. Prevalence and definition of drooling in Parkinson's disease: a systematic review. J Neurol. 2009; 256: 1391-1396.
    6. Maenner MJ, et al. Prevalence of cerebral palsy and intellectual disability among children identified in two US National Surveys, 2011-2013. Ann Epidemiol. 2016; 26(3): 222-226.
    7. Reid SM, et al. Prevalence and predictors of drooling in 7- to 14-year-old children with cerebral palsy: a population study. Dev Med Child Neurol. 2012; 54: 1032-1036.
    8. Mozaffarian D, et al. Heart disease and stroke statistics – 2016 update. Circulation. 2016; 133: e38-e360.
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    13. Maher S, et al. Clozapine-induced hypersalivation: an estimate of prevalence, severity, and impact on quality of life. Ther Adv Psychopharmacol. 2016; 6(3): 178-184.

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