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): May 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))

 

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

 

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

 

 

 


 

Item 7.01 Regulation FD Disclosure.

 

On May 6, 2019, Osmotica Pharmaceuticals plc (the “Company”) issued a press release announcing topline data from the Phase III clinical trial for RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%). A copy of the press release is furnished as Exhibit 99.1.

 

The Company also intends to use the presentation regarding the RVL-1201 topline data furnished herewith on a conference call scheduled for 12:00 p.m. EDT on May 7, 2019 and in other meetings or presentations with investors and analysts. The presentation will also be available online at https://ir.osmotica.com/events-presentations following the conference call. A copy of the presentation is furnished as Exhibit 99.2.

 

The information contained in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 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

 

Press Release issued by Osmotica Pharmaceuticals plc on May 6, 2019.

 

 

 

99.2

 

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: May 7, 2019

 

 

3


Exhibit 99.1

 

 

 

Osmotica Pharmaceuticals plc Announces Positive Topline Results of Phase III Clinical Trials of RVL-1201 (“RVL”) for Acquired Blepharoptosis (ptosis or droopy eyelid)

 

- Second Phase III Study 202 Meets Primary Endpoint; Provides Additional Evidence of Efficacy and Safety -

 

- Long-term Phase III Study 203 Provides Additional Evidence of Safety -

 

- Company to Host Conference Call on Tuesday, May 7th at 12pm ET with Dr. Chuck Slonim and Dr. Shane Kannarr -

 

Bridgewater, NJ, May 6, 2019 — Osmotica Pharmaceuticals plc (“Osmotica” or the “Company”) (Nasdaq: OSMT), a fully integrated biopharmaceutical company, today announced positive topline results of its second Phase III efficacy and safety clinical trial (Study 202) of RVL (oxymetazoline hydrochloride ophthalmic solution, 0.1%) and long-term Phase III safety study (Study 203) for the treatment of ptosis (droopy eyelid).

 

“We are very pleased with the positive topline results of our second Phase III clinical Study 202 of RVL for the treatment of ptosis evaluating efficacy and safety compared to placebo. Our topline readout is consistent with our prior study results, which demonstrated a statistically significant improvement in the visual field of patients that were administered our once-daily drop. The topline readout also suggests that RVL was well tolerated by patients in this study. Given the positive topline results from this study, combined with our recently completed long-term safety Study 203, we intend to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2019. If approved, we could be on the market as early as the second half of 2020,” said Brian Markison, Chairman and Chief Executive Officer at Osmotica.

 

“We believe there is a large prevalence of ptosis and today there is no FDA-approved pharmacologic intervention for any of these patients. If approved, RVL would be the first non-surgical option available for patients. Administered as a single drop once daily, RVL has the potential to significantly improve the visual field of individuals living with the clinical sequelae of ptosis,” added Markison.

 

Study Design and Outcomes

 

Osmotica conducted a second Phase III, randomized, multicenter, double-masked, placebo-controlled, 6-week study (Study 202) to evaluate the efficacy and safety of a once-daily treatment of RVL compared to placebo for the treatment of ptosis.

 


 

Study 202 randomized 164 subjects (109 subjects on RVL and 55 subjects on placebo) in a 2:1 randomization scheme.

 

The primary efficacy endpoint was the mean change from baseline in the RVL group versus placebo group in the number of points seen on the top 4 rows of the Leicester Peripheral Field Test (LPFT) in the study eye at each of the following time points:

 

·                  Day 1 Hour 6

·                  Day 14 Hour 2

 

The increases at both time points in the number of points seen in the superior visual field (change in LPFT) in the RVL group compared to the placebo group were highly statistically significant (p < 0.0001). RVL administered once daily to patients was also generally well tolerated in this study. The overall incidence of adverse events (AEs) was similar to that of placebo.

 

The topline results from Study 202 are consistent with the results of Osmotica’s previously reported Phase III Study 201, which evaluated the efficacy and safety of RVL in patients with ptosis.

 

Additionally, Osmotica conducted a 12-week, randomized, multicenter, double-masked, placebo-controlled Phase III study (Study 203) to evaluate the long term safety of RVL compared with placebo in the treatment of ptosis. The study included 234 patients (157 RVL and 77 Placebo) who were randomized in a 2:1 ratio, receiving either RVL or placebo once a day.  RVL was generally well tolerated in this study, and the AEs that were observed were predominantly mild in intensity. A total of 50 subjects (31.8%) in the RVL group and 23 subjects (29.9%) in the placebo group reported AEs. There were no deaths during the study. Two subjects in the RVL group experienced a Serious AE that were not considered related to study medication.

 

Conference Call

 

Brian Markison (Chief Executive Officer), JD Schaub (Chief Operating Officer), Tina deVries (EVP Research and Development), David Jacobs (VP Clinical Development), Dr. Chuck Slonim (Key Opinion Leader), and Dr. Shane Kannarr (Key Opinion Leader), will host a conference call as follows:

 

Date

Tuesday, May 7, 2019

 

 

Time

12:00 p.m. EDT

 

 

Toll free (U.S.)

(866) 672-5029

 


 

International

(409) 217-8312

 

 

Conference ID

7986401

 

 

Webcast (live and replay)

www.osmotica.com under the “Investor & News” section

 

The webcast will be archived for 30 days at the aforementioned URL.

 

About Acquired Blepharoptosis

 

Blepharoptosis is drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. If FDA approved, RVL would be the first non-surgical treatment option for patients with acquired blepharoptosis.

 

About Osmotica Pharmaceuticals plc

 

Osmotica Pharmaceuticals plc is a fully integrated biopharmaceutical company focused on the development and commercialization of specialty products that target markets with underserved patient populations. Our diversified product portfolio in the specialty neurology and women’s health therapeutic areas, together with our non-promoted complex formulations of generic drugs, form the foundation of our unwavering commitment to improve patients’ lives.

 

Osmotica has a late-stage development pipeline highlighted by two NDA candidates that recently completed Phase III clinical trials: arbaclofen extended-release tablets for spasticity in multiple sclerosis patients and RVL-1201 (oxymetazoline hydrochloride ophthalmic solution, 0.1%) for the treatment of blepharoptosis, or droopy eyelid.

 

Forward Looking Statements

 

This press release includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, our ability to operate our business under our new capital and operating structure, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs.  By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not

 


 

occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.  Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully 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 forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

 

Osmotica has operations in the United States, Argentina, and Hungary.

 

Investor and Media Relations for Osmotica Pharmaceuticals plc

Lisa M. Wilson

In-Site Communications, Inc.

T: 212-452-2793

E: lwilson@insitecony.com

 


Exhibit 99.2

1` Osmotica Pharmaceuticals plc RVL Program Update May 2019

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2 Safe Harbor 2017 2018 This information includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, our results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of current products and the development, approval and introduction of new products, FDA and other regulatory applications, approvals and actions, the continuation of historical trends, our ability to operate our business under our new capital and operating structure, and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: our ability to successfully develop or commercialize new products, or do so on a timely or cost effective basis; our dependence on a limited number of products; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; our ability to service our substantial debt; our ability to raise additional capital; the impact of competition from both brand and generic companies; any interruption at our manufacturing facility, our warehouses or at facilities operated by third parties that we rely on for our products; our dependence on our major customers; our ability to develop and maintain our sales capabilities; the impact of any litigation related to allegations of infringement of intellectual property; any changes to the coverage and reimbursement levels for our products by governmental authorities and other third-party payors as a result of healthcare reform or otherwise; the impact of any changes in the extensive governmental regulation that we face; manufacturing or quality control issues that we may face; and other risks and uncertainties more fully 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 forward-looking statements speak only as of the time of this release and we do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required by law.

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3 Call Participants 2017 2018 Osmotica Pharmaceuticals Brian Markison, Chief Executive Officer Tina deVries, EVP Research & Development David Jacobs, VP Clinical Development Key Opinion Leaders Dr. Chuck Slonim Adjunct Professor of Ophthalmology Affiliate Professor of Plastic Surgery at the University of South Florida College of Medicine in Tampa, Florida Clinical Associate Professor of Ophthalmology University of Florida School of Medicine Gainesville, Florida Teaches physicians about oculoplastic diseases, diagnoses, and surgeries, as well as contact lens technology Lectured extensively to ophthalmologists, optometrists and other physicians throughout the United States and in more than 35 international cities in more than 24 countries around the world Dr. Shane R. Kannarr At the forefront of contact lens technology with experience in toric, bifocal, and contact lenses for dry eyes Lectures across the country in the areas of ocular disease, ophthalmic medication, contact lenses, and practice management Treats all types of medical conditions relating to the eye, with specific interests in dry eyes, glaucoma, and diabetic eye disease Graduated from Pittsburg State University with a degree in biology education and earned his Doctorate of Optometry at the University of Missouri-St. Louis

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4 Potential First-In-Class Pharmacologic Treatment Option 2017 2018 If Approved, RVL will be Positioned as a Global Brand for Treatment of Blepharoptosis (Droopy Eyelid) 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 Highlights We believe there is a large global patient population with significant unmet need 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 RVL Overview Before Treatment After Treatment

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5 What is Ptosis 2013 Ptosis can be generally classified into two types: congenital (patients born with condition) and 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 Blepharoptosis (ptosis) is an abnormal low lying upper eyelid margin or droopy eyelid American Academy of Ophthalmology Severity Classifications Mild Moderate Severe Upper eyelid positioning 1 to 2 mm inferior to the upper limbus Upper eyelid positioning 3 to 4 mm inferior to the upper limbus Upper eyelid positioning > 4 mm inferior to the upper limbus

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6 Leicester Peripheral Field Test (LPFT) Primary Endpoint Measuring Improvement in Patient’s Visual Field Primary Endpoint: LPFT Phase 3 Efficacy Studies The LPFT, a customized visual field test designed specifically to assess ptosis, was performed using and HVF analyzer It is an age-corrected screening test with a three-zone strategy Thirty-five points (in the 4 rows at or above 10° from fixation) were tested in the superior field The 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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7 Marginal Reflex Distance (MRD) Key Secondary Endpoint Marginal reflex distance (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 4-5 mm MRD

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8 Clinical Trials Overview Clinical Development Program is Complete; NDA Submission Planned for Q3 2019 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

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9 Study RVL-202 Demographics & Baseline Characteristics RVL (n = 109) Placebo (n = 55) Overall (n = 164) Age, years, mean ± SD 63.6 ± 14.3 63.3 ± 16.5 63.5 ± 15.0 Sex, n (%) Male 32 (29.4) 16 (29.1) 48 (29.3) Female 77 (70.6) 39 (70.9) 116 (70.7) Race, n (%) White 99 (90.8) 50 (90.9) 149 (90.9) Black 6 (5.5) 3 (5.5) 9 (5.5) Other 4 (3.7) 2 (3.6) 6 (3.7) Ethnicity, n (%) Hispanic/Latino 13 (11.9) 6 (10.9) 19 (11.6) Not Hispanic/Latino 96 (88.1) 49 (89.1) 145 (88.4) SD, standard deviation. 2:1 randomization Comparable demographics across treatments

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10 Clinical Performance – Efficacy (LPFT) Statistically Significant Increase in Patient Field of Vision Observed in Both Phase 3 Studies p < 0.0001 p <0.0001 p < 0.0001 p < 0.0001 5.2 6.4 1.5 2.2 - 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 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 - 1.0 2.0 3.0 4.0 5.0 6.0 7.0 8.0 9.0 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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11 Treatment-Emergent Adverse Events (TEAE) – Eye Disorders TEAEs by Preferred Term (Study 202) RVL (n = 109) Placebo (n = 55) Conjunctival hyperemia 6 (5.5) 1 (1.8) Punctate keratitis 4 (3.7) 1 (1.8) Eye pain 3 (2.8) 0 (0) Dry eye 2 (1.8) 0 (0) Vision blurred 2 (1.8) 0 (0) Eye pruritus 0 (0) 2 (3.6) RVL was Generally Well Tolerated by Patients in Phase 3 Clinical Study 202 & 203 Data shown as n (%) where n is the number of subjects who reported a TEAE TEAEs by Preferred Term (Study 203) RVL (n = 157) Placebo (n = 77) Dry Eye 7 (4.5) 1 (1.3) Conjunctive Hyperemia 5 (3.2) 1 (1.3) Eye Irritation 2 (1.3) 0 (0) Meibomian gland dysfunction 2 (1.3) 0 (0) Punctate Keratitis 2 (1.3) 0 (0)

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12 Patient Photos Before After Subject 1 Subject 2 Subject 3

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13 Conclusions & Next Steps 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 AE, adverse event; LPFT, Leicester Peripheral Field Test; MRD, marginal reflex distance. Estimated NDA Submission Q3 2019 Pre-NDA Meeting with the FDA June 3rd RVL Commercial Introduction Planned 2H 2020

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