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 6, 2019

 

Osmotica Pharmaceuticals plc

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-38709

 

Not Applicable

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(IRS Employer
Identification No.)

 

400 Crossing Boulevard
Bridgewater, NJ

 

08807

(Address of principal executive offices)

 

(Zip Code)

 

(Registrant’s telephone number, including area code): (908) 809-1300

 

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:

 

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 (17 CFR 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:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which
registered

Ordinary Shares

 

OSMT

 

Nasdaq Global Select Market

 

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.

 

Beginning on June 6, 2019, Osmotica Pharmaceuticals plc intends to use the presentation furnished herewith, or portions thereof, in one or more meetings or presentations with investors and analysts. The presentation will also be available online at https://ir.osmotica.com/events-presentations as of June 6, 2019. A copy of the presentation is furnished as Exhibit 99.1.

 

The information contained in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit
No.

 

Description

99.1

 

Investor Presentation

 

2


 

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.

 

 

 

OSMOTICA PHARMACEUTICALS PLC

 

 

 

 

 

 

By:

/s/ Andrew Einhorn

 

 

Andrew Einhorn
Chief Financial Officer

 

 

Date: June 6, 2019

 

3


Exhibit 99.1

 

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Investor Presentation / June 2019

 

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1 Safe Harbor This presentation contains forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. All statements other than statements of historical facts contained in this presentation, including information concerning the timing of clinical and commercial development and launch plans with respect to our products and product candidates, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors, including that failures of or delays in clinical trials could jeopardize or delay our ability to obtain regulatory approval and commence product sales for new products, as well as the other factors that are described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2018 and other filings that the Company makes with the Securities and Exchange Commission. These risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these uncertainties, you should not place undue reliance on any forward-looking statements in this presentation. The forward-looking statements included in this presentation are made only as of the date hereof. We 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, neither we nor our advisors nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Neither we nor our advisors undertake any obligation to update any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations, except as may be required by law. You should read this presentation with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. Non-GAAP Financial Measures We present Adjusted EBITDA to help us describe our operating performance. Our presentation of Adjusted EBITDA is intended as a supplemental measure of our performance that is not required by, or presented in accordance with, U.S. generally accepted accounting principles (“GAAP”). Adjusted EBITDA should not be considered as an alternative to operating income (loss), net income (loss) or any other performance measures derived in accordance with U.S. GAAP as measures of operating performance or operating cash flows or as measures of liquidity. Our presentation of Adjusted EBITDA should not be construed to imply that our future results will be unaffected by these items. See the appendix to this presentation for a reconciliation of Adjusted EBITDA to net income (loss).

 

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2 Fully integrated and diversified biopharmaceutical company focused on the development and commercialization of specialty products that target markets with unmet medical needs

 

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3 Investment Highlights Led by proven management team with a track record of successful operating and business development experience 5 Two advanced late stage Phase III programs: RVL-1201 for acquired blepharoptosis: would be the first pharmacological treatment in a very large global market Arbaclofen ER for muscle spasticity in Multiple Sclerosis 2 R&D capacity and capability that leverages proprietary Osmodex® Drug Delivery System 3 Strong IP coupled with complex manufacturing capabilities 4 Diversified portfolio of promoted and non-promoted products generated $264M of Revenue and $95M of Adjusted EBITDA in 2018 1

 

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4 Company History 2018 NDA Approved Osmolex ER (amantadine ER) 2017 ANDA Approved methylphenidate ER (CONCERTA ®) 2016 ANDA approved Hydromorphone ER (EXALGO ®) 2013 NDA approved Khedezla ® (desvenlafaxine) 2009 ANDA approved Oxybutynin ER (DITROPAN XL ®) 2008 NDA approved Venlafaxine ER 2007 ANDA approved Nifedipine ER (PROCARDIA XL ®) Long History of Successful Product Approvals 2017 ANDA Approved M-72 (CONCERTA ®) 2004 NDA approved 24hr Allegra-D® (fexofenadine/ pseudoephedrine) Fully integrated commercial and development platform Trigen (Generics) Methylphenidate ER Venlafaxine ER Portfolio of Prenatal Vitamins ~35 total non-promoted products Vertical (Specialty Brands) All trademarks are the property of their respective owners. Specialty Pharmaceutical Commercial Platform Generic Pharmaceutical Commercial Platform Development capability with platform Osmotic delivery technology

 

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5 Osmotica Corporate Strategy FY 2018 Net Revenue Mix 2023 Target Net Revenue Mix (1) (1) We plan to leverage our existing sales force to grow our promoted product portfolio. However, actual net revenue mix may differ from these targets and such differences may be material. Transitioning to a pure specialty pharmaceutical company Leveraging specialty neuro and ophthalmology portfolios Supplementing organic growth with business development opportunities that fit core strategy Building a Branded Business Specialty Neurology Women's Health Non - Promoted Specialty Neurology Ophthalmology Women's Health Non - Promoted

 

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Product Indication (Anticipated) Exploratory Phase I Phase II Phase III Approval Commercial Osmodex ADHD in patients aged 13 - 65 Parkinson’s / drug-induced extra-pyramidal reactions Acquired Blepharoptosis (droopy eyelid) Submit NDA 3Q 2019 MS Spasticity Neurodegenerative Disease Opioid use Disorder Once-Daily Late-Stage Pipeline Overview 6 Expanding asset portfolio and pipeline leveraging Osmodex® drug delivery system M-72 (methylphenidate hydrochloride ER) Osmolex ER (amantadine ER) Arbaclofen ER (Ontinua ER) Arbaclofen ER (Life Cycle) (Ontinua ER) Additional potential targets from Osmodex platform in development Capacity to advance new programs RVL-1201 (oxymetazoline hydrochloride ophthalmic solution) OS870

 

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RVL-1201

 

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2017 2018 RVL is a novel prescription eye drop in clinical development for treatment of blepharoptosis, which has the potential to improve field of vision by stimulating the Müller’s muscle Convenient once-daily dosing with fast onset and durability of effect Completed robust clinical development program NDA submission targeted by end of Q3 2019 NDA approval as early as mid-2020 Worldwide commercial rights with global IP and patent portfolio If Approved, RVL will be Positioned as a Global Brand for Treatment of Blepharoptosis (Droopy Eyelid) Potential First-In-Class Pharmacologic Treatment Option 8 We believe there is a large global patient population with a significant unmet need 1X

 

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2013 Ptosis can generally be classified into two types: congenital (patients born with condition) acquired (patients that develop the condition) Acquired ptosis, the most common type of ptosis, is characterized by Upper eyelid covering the top surface of the eye Increased distance between the upper eyelid and the eye brow Asymmetric appearance between the eyes Obstructed pupil Reduced visual field American Academy of Ophthalmology Severity Classifications Blepharoptosis (ptosis) is an abnormal low lying upper eyelid margin or droopy eyelid What is Ptosis? 9 Mild Upper eyelid positioning 1 to 2 mm inferior to the upper limbus Moderate Upper eyelid positioning 3 to 4 mm inferior to the upper limbus Severe Upper eyelid positioning > 4 mm inferior to the upper limbus

 

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Observed in US ophthalmology, optometry, dermatology, and plastic surgery offices each year Only a small percentage of patients are currently treated Ptosis: A Large Unmet Need Approximately 1.4 M Diagnosed Patients ~16.8 M Total Ptosis Patients ~150,000 Patients Treated with Surgery (Reimbursed) 10 ~3.1 M Observed Patients Surgery is the only long-term treatment, but few patients have severe enough disease to qualify for insurance coverage While no robust epidemiological studies exploring the prevalence of blepharoptosis in the United States exist, we believe it is a common condition affecting millions of Americans. Although we believe the numbers presented in the graphic above reflect the approximate potential market opportunity in the United States based on our research and available market information, there is no assurance that the market opportunity will not differ from such numbers and such difference could be material. Medical claims analysis suggests approximately 150,000 patients undergo functional blepharoplasty surgery each year. Additionally, the American Society of Plastic Surgeons reported 206,529 cosmetic blepharoplasty procedures in 2018. (Source: Company research, American Society of Plastic Surgeons) Assumes the fully loaded cost of a blepharoplasty surgery is $4,750, the American Society of Plastic Surgeons indicated the average surgeon fee for a blepharoplasty was $3,026 in 2017. Surgeon fees exclude other costs such as anesthesia, operating room facilities or other related expenses <3% of ptosis patients in the US are treated each year (1) $1.5+B estimated spend on blepharoplasty surgeries in the US annually (2) 10.5% 89.5% Treated Untreated

 

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Phase III, randomized, multicenter, double-masked, placebo-controlled study comparing once-daily RVL 0.1% with placebo in patients with acquired blepharoptosis Enrollment: 140 Primary Endpoint Mean change from baseline in number of points seen in top 4 rows of LPFT Exploratory Endpoint: mean observed MRD values 201 COMPLETED Phase III, randomized, multicenter, double-masked, placebo-controlled, 6-week study to evaluate the safety and efficacy of once-daily treatment with RVL compared with placebo for the treatment of acquired blepharoptosis Enrollment: 164 Primary Endpoint: Mean change from baseline in number of points seen in top 4 rows of LPFT Secondary Endpoint: mean observed MRD values COMPLETED Phase III, randomized, multicenter, double-masked, placebo-controlled, 12-week study to evaluate the extended safety of RVL compared with placebo for the treatment of acquired blepharoptosis Enrollment: 234 Primary Endpoint: (Safety) COMPLETED 202 203 Phase 1/2, randomized, multicenter, double-masked, placebo-controlled study comparing RVL 0.1% once-daily and twice-daily to placebo in patients with acquired blepharoptosis Enrollment: 46 Primary Endpoint: mean increase from baseline in points seen on the Humphrey Visual Field (“HVF”) 001 COMPLETED Clinical Trials Overview Clinical Development Program is Complete; NDA Submission Planned for Q3 2019 11

 

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Measuring Improvement in Patient’s Visual Field Primary Endpoint: Leicester Peripheral Field Test (LPFT) 12 Phase 3 Efficacy Studies 201 & 202 Primary Endpoint The LPFT, a customized visual field test designed specifically to assess ptosis, was performed using an HVF analyzer It is an age-corrected screening test with a three-zone strategy 35 points (in the 4 rows at or above 10° from fixation) were tested in the superior field LPFT was performed on both eyes at Screening (Visit 1); only performed on the “study eye” in Visit 2 and 3 LPFT score was tallied based on the total number of points seen in the top 4 rows on the LPFT Superior Field

 

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Statistically Significant Increase in Patient Field of Vision Observed in Both Phase 3 Studies Study Results 201 & 202: Efficacy 13 p < 0.0001 p <0.0001 p < 0.0001 p < 0.0001 5.2 6.4 1.5 2.2 0 1 2 3 4 5 6 7 8 9 Hour 6 on Day 1 Hour 2 on Day 14 Study 201 Mean Change in LPFT from Baseline (Leicester Peripheral Field Test) RVL Placebo 6.3 7.7 2.1 2.4 0 1 2 3 4 5 6 7 8 9 Hour 6 on Day 1 Hour 2 on Day 14 Study 202 Mean Change in LPFT from Baseline (Leicester Peripheral Field Test) RVL Placebo

 

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Phase 3 Clinical Studies 201 & 202 Key Secondary Endpoint: Marginal Reflex Distance (MRD) 14 MRD is the distance between the center of the pupillary light reflex and the upper eyelid margin with the eye in primary gaze. MRD is determined by the examiner and patient aligning at the same level A light is directed at the patient’s eyes The measurement in millimeters is taken from the light on the patient’s cornea to the center of the upper eyelid margin Normal MRD is > 4 mm MRD

 

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Significantly increased MRD for all post-dose measurements Study Results 202 – Secondary Endpoint: MRD 15 P<0.05 for all post-dose measurements 0 0.2 0.4 0.6 0.8 1 1.2 1.4 Time 5 min. 15 min. 2 hours 6 hours 5 min. 15 min. 2 hours 6 hours 5 min. 15 min. Day 1 1 1 1 14 14 14 14 42 42 p-value 0.0007 <0.0001 <0.0001 <0.0001 0.0151 <0.0001 <0.0001 <0.0001 0.002 0.0003 Change from baseline in MRD (mm) RVL-1201 (N = 109) Vehicle (N = 55)

 

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16 Study Results 201 & 202: Efficacy Predose After 2 Hours After 6 Hours

 

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Study Results 202: Safety 17 The majority of AEs were mild and did not require treatment. RVL was well tolerated when administered once daily over a 6-week period. Overall Summary of Treatment-Emergent Adverse Events (Safety Population), Study 202 Analysis RVL-1201 N = 109 Vehicle N = 55 Number of subjects reporting any TEAEs, n (%) 35 (32.1%) 21 (38.2%) Number of TEAEs reported(a), n 65 46 Subjects reporting TEAEs by maximum intensity(b), n (%) Mild 29 (26.6%) 16 (29.1%) Moderate 6 (5.5%) 5 (9.1%) Severe 0 0 Subjects reporting any TEAEs leading to discontinuation from the study, n (%) 1 (0.9%) 1 (1.8%) (a)TEAE = treatment-emergent adverse event (b)Subjects reporting one or more adverse events are counted once at the maximum intensity of all adverse events. RVL was Generally Well Tolerated by Patients in Phase 3 Clinical Study 202

 

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Study RVL-202 (Safety & Efficacy) The study met the primary endpoint for change from baseline for LPFT Significant improvement seen in MRD for all observed time points post dose RVL was generally well tolerated; most AEs were mild or moderate Study RVL-203 (Extended Safety) RVL administered once daily to patients with acquired blepharoptosis was safe and generally well tolerated in this 3-month double-masked safety study. The overall incidence of adverse events was similar to that of placebo Next Steps 18 Study Results Summary Pre-NDA Meeting with the FDA June 3rd Planned NDA Submission Q3 2019 RVL Commercial Introduction Planned 2H 2020

 

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Arbaclofen Extended Release (ER)

 

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Indication Muscle spasticity in multiple sclerosis patients with potential for multiple additional indications Regulatory Status Orphan Drug Designation; second phase III trial completed; top-line data 1Q 2019 Intellectual Property Eligible for 7-year data exclusivity; multiple patents extending to 2036 Designed to overcome the limitations of baclofen Arbaclofen ER: Potentially Meaningful Improvement for Patients 20 Baclofen is the only FDA-approved product that targets the GABAB receptor to treat spasticity Somnolence is one of the more common and disruptive side effects that can limit overall efficacy S-isomer believed to inhibit affinity for GABAB, leading to greater side effects Baclofen has a high incidence of tolerability problems limiting patient compliance High unmet need among patients and physicians due to significant dissatisfaction with current therapy options Arbaclofen, the, R-isomer of baclofen, is a single enantiomer, that may support greater efficacy and tolerability Arbaclofen is up to 100 times more effective at targeting the GABAB receptor than the S-isomer Convenient dosing schedule – Osmodex controlled release system permits BID dosing (2x daily) as compared to up to 4x daily for baclofen Potentially delays or replaces more expensive and complex management Clinical trial data shows: Fewer disruptive side-effects Met co-primary endpoints in Study 3002 Arbaclofen ER Solution Current Standard of Care (Baclofen)

 

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21 Arbaclofen ER: A Significant Market Opportunity “The Prevalence of Multiple Sclerosis in the United States: A Population-Based Healthcare Database Approach”, 2017. “Prevalence and treatment of spasticity reported by multiple sclerosis patients,” Multiple Sclerosis Journal 2004. Management estimate. Pricing for illustration purposes only and actual net market value may differ and such difference could be material. 947,000 757,600 492,440 12 Months of Therapy $450 - $600 (4) Price per Rx / Month MS Patients in US (1) MS Patients with some form of Spasticity in US (2) MS Spasticity Patients Receiving Treatment (3) Up to $3.5 billion net market value Prevalence of MS is on the rise

 

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22 Arbaclofen ER: Phase III Clinical Trial Overview Multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group, 12-week study to evaluate safety, tolerability, and efficacy of Arbaclofen ER 40mg/day, baclofen 80mg/day vs. placebo (1:1:1) 3002 COMPLETED CGIC Scale (Clinical Global Impression of Change) Global, widely-accepted rating scale that captures investigator’s assessment of the subject’s change in overall functional performance Scores range from -3 (significant worsening) to +3 (significant improvement) Note: CGIC, clinical global impression of change; TNmAS, total numeric modified Ashworth scale. TNmAS/ Modified Ashworth Scale (assessed in the most affected limb) Gold standard for evaluation of muscle spasticity in subjects with neurological conditions 6-point rating scale to objectively measure abnormality in tone or the resistance to passive movements High scores indicate more severe spasticity Extensively used in spasticity studies Demonstrated validity and reliability Multicenter, open-label, uncontrolled study to evaluate the safety and tolerability of Arbaclofen ER 40mg/day over 12 months 3003 COMPLETED Randomized double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of Arbaclofen ER 40mg/day, Arbaclofen ER 80mg/day vs. placebo for the treatment of spasticity in patients with multiple sclerosis 3004 COMPLETED Open-label extension study to evaluate the long-term safety of Arbaclofen ER in multiple sclerosis patients with spasticity 3005 IN PROGRESS

 

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P = 0.0004 P = 0.0006 23 Study Results 3002: Co-Primary Endpoints TNmAS & CGIC -2.90 -1.95 1.00 0.52 Day 120 Arbaclofen ER vs. Placebo: p=0.0006 Baclofen vs. Placebo: P<0.0001 Day 120 Arbaclofen ER vs. Placebo: p= 0.0004 Baclofen vs. Placebo: p= 0.2434 22 36 50 71 120 22 36 50 71 120 Note: CGIC, clinical global impression of change; TNmAS, total numeric modified Ashworth scale. CGIC Change at Day 120 Arbac ER Placebo -3.5 -3.0 -2.5 -2.0 -1.5 -1.0 -0.5 0.0 0 Change in TNmAS Day of Treatment Ontinua ER Baclofen Placebo 0.0 0.2 0.4 0.6 0.8 1.0 1.2 0 Change in CGIC Day of Treatment Ontinua ER Baclofen Placebo

 

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Study 3002: Adverse Events >2% Safety Profile 24 Arbaclofen ER (N = 110) Baclofen (N = 113) Placebo (N = 118) Somnolence 17 (15.5) 27 (23.9) 6 (5.1) Dizziness 8 (7.3) 12 (10.6) 4 (3.4) Headache 8 (7.3) 7 (6.2) 1 (0.8) Multiple sclerosis relapse 3 (2.7) 0 4 (3.4) Muscle spasticity 3 (2.7) 2 (1.8) 2 (1.7) Urinary tract infection 9 (8.2) 12 (10.6) 6 (5.1) Nasopharyngitis 3 (2.7) 2 (1.8) 4 (3.4) Asthenia 13 (11.8) 21 (18.6) 5 (4.2) Muscular weakness 12 (10.9) 13 (11.5) 3 (2.5) Pollakiuria 6 (5.5) 11 (9.7) 3 (2.5) Micturition urgency 0 6 (5.3) 0 Dry mouth 1 (0.9) 7 (6.2) 0 Vertigo 3 (2.7) 6 (5.3) 0 Study 3002 – 12 Week Safety Study Compared to Arbaclofen ER .baclofen, as measured by AEs, had: 54% greater incidence of somnolence, and 86% greater incidence of urinary symptoms Arbaclofen ER administered twice a day was efficacious and safe in MS patients with spasticity

 

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Safety Profile 25 Adverse Event All Subjects (1) (N = 184) CNS disorders, n (%) 11 (6.0) Somnolence 5 (2.7) Dizziness 1 (0.5) Renal and urinary disorders, n (%) 5 (2.7) Pollakiuria 3 (1.6) Micturition urgency 2 (1.1) Urinary incontinence 2 (1.1) Polyuria 1 (0.5) Arbaclofen ER AEs were comparable to those observed with placebo in Study 3002 Study 3003 – Long Term (12 month) Safety Study Study 3003: Adverse Events Leading to Drug Interruption or Discontinuation Comprised of rollover subjects from Study 3002 and de novo subjects.

 

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Completed second Phase III clinical trial of arbaclofen ER for the treatment of spasticity in Multiple Sclerosis (MS) patients in Q1 2019 Study results are mixed: Arbaclofen ER demonstrated statistically significant improvement in spasticity relative to placebo for the TNmAS for the most affected limb for both 40-mg and 80-mg doses. Arbaclofen ER did not demonstrate superiority to placebo as measured by CGIC Although arbaclofen ER 80 mg/day had a higher discontinuation rate in this study, the safety and tolerability profile was in line with previously reported results; somnolence was reported by 10.1% and 14.5% of subjects for the 40-mg and 80-mg treatment arms, respectively compared to 10.1% for the placebo treatment arm Further evaluation and analysis is ongoing Efficacy signal for the treatment of spasticity identified by the TNmAS endpoint is a positive result, and the profile of arbaclofen ER could offer a meaningful benefit to MS patients who suffer from spasticity We intend to meet with the FDA in Q3 2019 26 Second Phase III Study (3004) Summary Results

 

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24 Second Phase III Study (3004) Summary Results Arbaclofen ER demonstrated statistically significant improvement in spasticity relative to placebo for the change from baseline (“CFB”) TNmAS for the most affected limb (“MAL”) for both 40-mg and 80-mg doses. larger decrease indicates greater improvement in spasticity

 

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Key Promoted Product Overviews

 

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Market Opportunity Primary strategy: target prescribers of 2x 36mg ~25% of 3M annual 36mg scripts are prescribed 2x daily (72mg) (2) High incidence in the U.S. 6+ million children aged 2-17 (approximately 9.4% in 2016) Estimated 4.4% of adults aged 18-44 have ADHD Profile & Market Opportunity M-72 Overview 29 ~750K Rx 25% 3M Rx 36mg dosage First and only single-dose 72mg methylphenidate ER tablet for ADHD; opportunity to convert existing market DACON = daily average consumption. Sources: IQVIA Health & Truven Health Analytics. ` Indication ADHD in patients aged 13-65 Regulatory Status FDA approved July 2017 Commercial Launch April 2018 Dosing Patients can take one tablet in the morning Intellectual Property 3 issued patents extending to 2037 Key Features Bioequivalent to branded Methylphenidate – a proven first-line treatment of ADHD Convenient for patients to switch from two 36mg tablets to one 72mg tablet daily Simplified dispensing for pharmacy (1) 36mg TRx 72mg DACON

 

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Company Data – March 2019 Robust patient access to product: >50% of commercial patients with initial out-of-pocket copays $20 or less (Tier 1) (1) M-72 Launch Update 30 Primary position in Neurology Field Force; tele-detailing campaign reaching additional prescribers Over 4,000 unique HCPs have prescribed M-72 since its introduction in Q2 2018 Month-over-month growth in prescriptions and prescribers each month since launch Focus on maintaining growth momentum with fresh commercial and product access initiatives Foundation for Growth in Place 0 500 1,000 1,500 2,000 2,500 3,000 3,500 Steady Uptake Through Initial 4 Quarters of Launch M-72 Prescriptions 0 500 1000 1500 2000 2500 Expanding Prescriber Base

 

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Profile & Market Opportunity Osmolex ER Overview 31 Sources: IQVIA data, Symphony Health data, and Company estimates Market Opportunity (1) > $400 million market opportunity based on Wholesale Acquisition Cost pricing ~1M amantadine IR Rx annually Estimated 50% Rx written by neurologists and movement disorder specialists in 2017 Estimated 19% of Rx written by psychiatry specialists from Q4 2015 – Q3 2016 Indication Parkinson’s Disease and drug-induced extrapyramidal reactions in adults Regulatory Status Approved February 2018 Commercial Launch Full Launch January 2019 Dosing Immediate-release outer core with extended-release inner core for convenient once-daily dosing in the morning Intellectual Property Two formulation patents, one of which extends to 2030; Two methods of treating patents to February 2038 Key Features Cmax in the middle of the day as the product is administered in the morning Osmotic delivery designed to produce a consistent delivery of amantadine throughout the day, and is available in multiple strengths for added dosing flexibility (129mg, 193mg, 258mg) Amantadine IR Prescribers New once-daily treatment option for Parkinson’s Disease and drug-induced extrapyramidal reactions in adults 50% 19% 31% Neurologists and Movement Specialists Psychiatrists Other

 

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1) Affordable access to an extended release amantadine product Osmolex ER priced at WAC of $450/month, minimizing risk of placement on a specialty tier and co-pay/coinsurance burden for patients Co-pay assistance for commercial patients Access Osmolex™ for office and patient support, dedicated to assisting patients in gaining access to Osmolex ER Contract strategy, where appropriate, to support broad coverage 2) Focused personal promotional effort with dedicated Sales team 32 sales representatives at launch, targeting ~3,500 HCP’s, already hired and trained 3) Complementary multi-channel marketing campaigns 4) Expanding efforts to advance patient and prescriber education, patient advocacy, and ensure appropriate access to innovative therapies Launch Overview Ensuring adult patients with Parkinson’s disease and drug-induced extrapyramidal reactions (EPR), their caregivers and providers, know about, and have access to Osmolex ER 29

 

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Financial Overview 33

 

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34 Financial Overview ($ in millions) Year Ended December 31, 3 Months Ended March 31, 2017 2018 1Q 2018 1Q 2019 Revenues $246 $264 $60 $57 Gross Profit 121 129 28 26 % of Revenue 49% 49% 45% 50% Adjusted EBITDA(1) 99 95 21 16 % of Revenue 40% 36% 35% 28% Balance Sheet Items Cash & Cash Equivalents $71 $38 $63 Total Debt(2) 272 272 Net Debt / Adjusted EBITDA(1) 2.1x(3) 2.3x(3) See the appendix to this presentation for a reconciliation of Adjusted EBITDA to net income (loss). Total Debt includes capital lease obligations. Calculated as Net Debt as of March 31, 2019 divided by 1Q 2019 Adjusted EBITDA plus 2018 EBITDA less 1Q 2018 EBITDA.

 

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35 Investment Highlights Led by proven management team with a track record of successful operating and business development experience 5 Two advanced late stage Phase III programs: RVL-1201 for acquired blepharoptosis: would be the first pharmacological treatment in a very large global market Arbaclofen ER for muscle spasticity in Multiple Sclerosis 2 R&D capacity and capability that leverages proprietary Osmodex® Drug Delivery System 3 Strong IP coupled with complex manufacturing capabilities 4 Diversified portfolio of promoted and non-promoted products generated $264M of Revenue and $95M of Adjusted EBITDA in 2018 1

 

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Appendix

 

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37 Adjusted EBITDA Reconciliation ($ in thousands) 3 Months Ended March 31, Year Ended December 31, 1Q 2019 1Q 2018 2018 2017 Net Loss $(6,200) $(4,607) (109,397) $(41,142) Interest expense 4,501 4,843 20,790 29,052 Income tax benefit (1,240) (1,195) (9,268) (44,500) Depreciation and Amortization 17,992 20,414 81,573 46,450 EBITDA $15,053 $19,455 $(16,302) $(10,140) Impairment of long-lived assets - - 17,903 72,986 Impairment of Goodwill 86,318 Share compensation expense 1,169 1,965 Write-off of acquired RevitaLid IPR&D(a) - - - 16,372 Management fees(b) (43) 250 921 1,000 Consulting fees - - - 552 Loss on extinguishment of debt and fees(c) - - 876 5,371 Acquired inventory step-up in cost of goods sold(d) - - - 9,175 API inventory disposal(e) - - - 468 Legal and contractual settlements and litigation reserves(f) - - 332 1,550 Severance expense(g) 182 445 679 589 Write-off of previously acquired balances(h) - - 1,209 IPO expenses(i) - 395 2,442 - Adjusted EBITDA $16,361 $20,545 $95,134 $99,132

 

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38 EBITDA Reconciliation (Cont’d.) (a) Acquired IPR&D of RevitaLid with no alternative future use expensed as research and development during the year ended December 31, 2017 (b) Includes quarterly advisory and monitoring fees of $0.25 million payable to the shareholders up until IPO. Q1 2019 fee represents reversal of overaccrual. (c) Deferred financing fees of $5.3 million and $0.4 million third-party fees expensed in connection with entering into an amendment to our senior secured credit facilities on December 21, 2017. $0.9 million of deferred financing fees expensed in connection with $50 million prepayment of debt on October 31, 2018. (d) Adjustment related to acquired VERT inventory, which was recorded above the cost that would have otherwise been recognized had such inventory been manufactured or purchased in the ordinary course of business, sold and expensed as cost of goods in 2016 and 2017. This adjustment included a one-time non-cash allocation of the purchase price for the reacquisition of marketing and distribution rights for VERT. (e) One time disposal of Desvenlafaxine inventory. (f) The $1.6 million and $0.3 million represent litigation, contract disputes and related amounts expensed during the year ended December 31, 2017 and 2018, respectively. (g) Severance of $0.6 million and $0.7 million relate to sales force realignment, staff reductions and related costs expensed during the years ended December 31, 2017 and 2018, respectively. Severance expenses of $0.4 million and $0.2 million represent staff reductions for the three months ended March 31, 2018 and 2019, respectively. (h) Write-off of balances of certain assets acquired and liabilities assumed in the Business Combination. (i) Incremental non-recurring organizational costs related to the initial public offering, which were expensed as incurred.