- TYRVAYA® (Varenicline Solution) Nasal Spray Achieved Net Product Revenue of
$5.6 Million in Q3’22 - Approximately 34,000 TYRVAYA Prescriptions Filled During the Quarter, with Prescriptions Written by Approximately 6,100 Unique Eye Care Professionals
November 1, 2022 Marked the First Anniversary of the Commercial Launch of TYRVAYA, with Over 97,000 Prescriptions Written as ofOctober 21, 2022 - Expanded Patient Access and Commercial Coverage for TYRVAYA, with Up to Approximately 117 Million Lives Covered to Date
Oyster Point Pharma to be Acquired byViatris , with the Transaction Expected to Close During Q1’23- Enrollment Completed in the
OLYMPIA Phase 2 Clinical Trial for Stage 1 Neurotrophic Keratopathy, with Data Readout Expected in Q1’23 - Positive Pre-IND Meeting Feedback from the FDA to Advance Enriched Tear Film Gene (ETF™) Therapy Towards Clinical Studies for Stages 2 and 3 Neurotrophic Keratopathy
“We are pleased with third quarter results while establishing TYRVAYA as the first and only nasal spray available as a treatment option for patients suffering from dry eye disease,” said
Recent Business Highlights
- TYRVAYA (Varenicline Solution) Nasal Spray Achieved Net Product Revenue of $5.6 Million in Q3’22 with Approximately 34,000 Prescriptions Filled: In Q3’22, the Company recognized
$5.6 million in net product revenue related to sales of TYRVAYA Nasal Spray, which was launched inNovember 2021 . Approximately 34,000 TYRVAYA prescriptions were filled during the third quarter of 2022. Prescriptions were written by approximately 6,100 unique eye care professionals during the quarter, reflecting the continued strong uptake of TYRVAYA, the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease. - November 1, 2022 Marked the First Anniversary of the Commercial Launch of TYRVAYA, with Over 97,000 Prescriptions Written as of
October 21, 2022 : Since TYRVAYA’s commercial launch inNovember 2021 , over 97,000 prescriptions of TYRVAYA have been filled by approximately 9,300 unique prescribers as ofOctober 21, 2022 , reflecting continued enthusiasm by eye care professionals. - Expanded Patient Access and Commercial Coverage for TYRVAYA: Following coverage determinations for TYRVAYA from all major
U.S. commercial payors as ofJuly 2022 , the Company has continued to expand patient access programs to include more eligible patients. According to MMIT, TYRVAYA now has commercial coverage for up to approximately 117 million lives, or 65% of allU.S. commercial lives. Oyster Point Pharma to be Acquired byViatris : OnNovember 7, 2022 , the Company announced that it has entered into a definitive merger agreement withViatris Inc. (Nasdaq: VTRS) (“Viatris”), a global healthcare company, pursuant to whichViatris would acquire the Company. Under the terms of the agreement,Viatris will initiate a tender offer to acquire all of the outstanding shares of the Company’s common stock at a price of$11.00 per share in cash at closing, plus a contingent value right (“CVR”) representing the right to receive a potential cash payment of up to$2.00 per share. The amount (if any) payable under the CVR will be based on the following performance targets to be achieved by the Company for full year 2022:- An additional
$1.00 per share in cash if the Company generates equal to or greater than$21.6 million of net product revenue and 131,822 total prescriptions of TYRVAYA inthe United States for the twelve months endedDecember 31, 2022 ; or - An additional
$2.00 per share in cash if the Company generates equal to or greater than$24.0 million of net product revenue and 146,469 total prescriptions of TYRVAYA inthe United States for the twelve months endedDecember 31, 2022 .
- An additional
The transaction is anticipated to close during the first quarter of 2023, subject to the closing conditions provided in the merger agreement.
Development Milestones
- Enrollment Completed in the
OLYMPIA Phase 2 Clinical Trial for Stage 1 Neurotrophic Keratopathy (NK), with Data Readout Expected in Q1’23: InOctober 2022 , the Company completed enrollment of patients in theOLYMPIA Phase 2 clinical trial of OC-01 (varenicline solution) nasal spray for the treatment of Stage 1 NK, with a data readout expected in the first quarter of 2023. Total enrollment in the study was 113 subjects at 34 U.S. centers, slightly more than the original target of 100 subjects. In theOLYMPIA Phase 2 clinical trial, OC-01 (varenicline solution) nasal spray is administered three times daily and will be compared to placebo (vehicle) nasal spray. The pre-specified primary endpoint of the trial is the mean change from baseline in corneal fluorescein staining in subjects with Stage 1 NK at Day 56. - Positive Pre-IND Meeting Feedback from the FDA to Advance Enriched Tear Film (ETF™) Gene Therapy Towards Clinical Studies for Stages 2 and 3 Neurotrophic Keratopathy: In Q3’22, the Company received positive pre-IND meeting feedback from the
U.S. FDA for the proprietary ETFTM gene therapy candidate, OC-101 (AAV-NGF), which is administered as a single, intralacrimal gland injection of an adeno-associated virus (AAV) vector containing the human nerve growth factor (NGF) gene for Stages 2 and 3 NK patients. The Company will commence IND-enabling studies in order to advance the program into clinical studies. During the third quarter of 2022, the Company also disclosed an additional target and further indications for its ETF gene therapy program. Pre-clinical studies are underway with an AAV vector containing diamine oxidase (DAO), a key enzyme involved in histamine degradation, for the treatment of Atopic Keratoconjunctivitis (AKC) and Vernal Keratoconjunctivitis (VKC).
Overview of Financial and Operating Results
Third Quarter 2022 Financial Results
- Cash Position: As of
September 30, 2022 , cash and cash equivalents was$68.8 million , compared to$104.9 million as ofJune 30, 2022 . The decrease in cash and cash equivalents during the three months endedSeptember 30, 2022 , of$36.1 million was primarily the result of amounts spent to fund marketing activities for TYRVAYA Nasal Spray. - Product Revenues, Net: Net product revenues for the three months ended
September 30, 2022 were$5.6 million . TYRVAYA Nasal Spray was approved by the FDA onOctober 15, 2021 , and commercially launched in theU.S. inNovember 2021 . The Company did not generate any revenues from product sales during the three months endedSeptember 30, 2021 . - Cost of Product Revenue: Cost of product revenue for the three months ended
September 30, 2022 was$1.3 million and consisted of material costs, third-party manufacturing costs, and royalty expense. - Sales and Marketing Expenses: Sales and marketing expenses increased by
$3.9 million during the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . The increase was primarily due to higher payroll-related expenses of$3.1 million , which was driven by the growth of the Company's sales force since 2021. Other sales and marketing expenses increased by$0.8 million during the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 , in connection with samples, trade shows, educational programs, patient services, payor access and other marketing efforts related to the commercialization of TYRVAYA Nasal Spray. - General and Administrative Expenses: General and administrative expenses increased by
$1.8 million during the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . The increase was primarily driven by additional payroll-related expenses of$2.7 million due to an increase in headcount to support the Company's business operations, including an increase in stock compensation expenses of$0.8 million . Other general and administrative expenses decreased by$0.9 million during the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 , primarily related to a decrease in sponsorships, public relations and recruiting activities. - Research and Development Expenses: Research and development expenses decreased by
$2.3 million during the three months endedSeptember 30, 2022 , compared to the three months endedSeptember 30, 2021 . The decrease was primarily due to decreased research and development activity relating to OC-01 (varenicline solution) nasal spray following its approval by the FDA onOctober 15, 2021 , and lower payroll-related expenses of$0.7 million . - Interest Expense: The Company incurred
$3.5 million and$1.1 million of interest expense during the three months endedSeptember 30, 2022 and 2021, respectively, related to the Company’s credit agreement with OrbiMed originally entered into inAugust 2021 . Interest expense for both periods included contractual interest, as well as the amortization of loan commitment fees and accretion of other long-term debt related costs. - Other Income, net: Other income for the three months ended
September 30, 2022 of$0.7 million consisted of a$0.4 million change in the fair value of the net embedded derivative liability related to the Company’s credit agreement with OrbiMed in addition to interest earned on money market funds. Other income for the three months endedSeptember 30, 2021 primarily consisted of$0.2 million of income associated with the change in the fair value of the net embedded derivative liability, as well as interest income earned on money market funds. - Net Loss: For the three months ended
September 30, 2022 , the Company had a net loss of$36.7 million , or ($1.37 ) per share, compared to a net loss of$17.7 million , or ($0.68 ) per share, for the three months endedSeptember 30, 2021 .
About
About TYRVAYA® (varenicline solution) Nasal Spray
TYRVAYA (varenicline solution) Nasal Spray 0.03 mg is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the "rest and digest" system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of TYRVAYA Nasal Spray in dry eye disease is believed to be the result of varenicline's activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. The exact mechanism of action is unknown at this time.
TYRVAYA® Important Safety Information
The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation. There are no contraindications associated with TYRVAYA (varenicline solution) Nasal Spray. Please see full Prescribing Information at www.tyrvaya-pro.com/prescribinginformation.
About Dry Eye Disease and the Role of Tear Film
Dry eye disease is a chronic condition that impacts an estimated 38 million people in the
Forward-Looking Statements
To the extent that statements contained in this press release are not statements of historical facts, they may be deemed to be forward-looking statements. In some cases, such forward-looking statements can be identified by terms such as “believes,” “plans,” “anticipates,” “continue,” “potential,” “seek,” “goal,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Such forward-looking statements are based on management’s current expectations, beliefs, estimates, projections and assumptions. As such, forward-looking statements are not guarantees of future performance and involve inherent risks and uncertainties that are difficult to predict. As a result, a number of important factors could cause actual results to differ materially from those indicated by such forward-looking statements, including: the risk that the proposed acquisition of
Additional Information about the Transaction and Where to Find It
The tender offer for the outstanding common stock of
References:
- Wirta, D., Vollmer, P., Paauw, J., Chiu, K. H., Henry, E., Striffler, K., ... &
ONSET-2 Study Group . (2021). Efficacy and Safety of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease: the ONSET-2 Phase 3, Randomized Trial. Ophthalmology. https://doi.org/10.1016/j.ophtha.2021.11.004 - Market-Scope. 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025.
October 2020 . - Tsubota K, Pflugfelder S, Liu Z, Baudouin C. Defining dry eye from a clinical perspective. Int J Mol Sci. 2020;21(23):1-24. https://pubmed.ncbi.nlm.nih.gov/33291796/
Investor Contact
(646) 436-4702
aahmed@oysterpointrx.com
Media Contact
(347) 920-0248
kpaff@oysterpointrx.com
Select Balance Sheet Data
(in thousands)
(unaudited)
December 31, 2021 | |||||||
Cash and cash equivalents | $ | 68,800 | $ | 193,372 | |||
Working capital* | $ | 68,510 | $ | 186,448 | |||
Total assets | $ | 109,201 | $ | 222,617 | |||
Long-term debt, net | $ | 92,218 | $ | 89,815 | |||
Stockholders’ equity (deficit) | $ | (22,202 | ) | $ | 99,537 | ||
* Working capital is defined as current assets less current liabilities. | |||||||
Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
Three months ended | Nine months ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue: | |||||||||||||||
Product revenue, net | $ | 5,591 | $ | - | $ | 12,988 | $ | - | |||||||
License revenue - related party | - | 17,943 | - | 17,943 | |||||||||||
Total revenue | 5,591 | 17,943 | 12,988 | 17,943 | |||||||||||
Cost of product revenue | 1,348 | - | 2,994 | - | |||||||||||
Operating expenses: | |||||||||||||||
Sales and marketing | 22,094 | 18,170 | 77,169 | 28,947 | |||||||||||
General and administrative | 12,149 | 10,327 | 39,079 | 27,938 | |||||||||||
Research and development | 3,913 | 6,214 | 13,258 | 18,772 | |||||||||||
Total operating expenses | 38,156 | 34,711 | 129,506 | 75,657 | |||||||||||
Loss from operations | (33,913 | ) | (16,768 | ) | (119,512 | ) | (57,714 | ) | |||||||
Other (expense) income | |||||||||||||||
Interest expense | (3,495 | ) | (1,124 | ) | (9,717 | ) | (1,124 | ) | |||||||
Other income (expense), net | 661 | 222 | (5,352 | ) | 243 | ||||||||||
Total other (expense) income, net | (2,834 | ) | (902 | ) | (15,069 | ) | (881 | ) | |||||||
Net loss and comprehensive loss | $ | (36,747 | ) | $ | (17,670 | ) | $ | (134,581 | ) | $ | (58,595 | ) | |||
Net loss per share, basic and diluted | $ | (1.37 | ) | $ | (0.68 | ) | $ | (5.03 | ) | $ | (2.25 | ) | |||
Weighted average shares outstanding, basic and diluted | 26,830,756 | 26,037,975 | 26,736,177 | 25,984,412 | |||||||||||
Source:
2022 GlobeNewswire, Inc., source