Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 3 analysts covering Oyster Point Pharma expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$11.1m in 2025. Average annual earnings growth of 59% is required to achieve expected profit on schedule. Price Target Changed • Nov 16
Price target decreased to US$24.20 Down from US$28.60, the current price target is an average from 5 analysts. New target price is 117% above last closing price of US$11.16. The company is forecast to post a net loss per share of US$6.32 next year compared to a net loss per share of US$3.87 last year. Aankondiging • Nov 09
Viatris Inc. (NasdaqGS:VTRS) entered into a definitive agreement to acquire Oyster Point Pharma, Inc. (NasdaqGS:OYST) for approximately $300 million. Viatris Inc. (NasdaqGS:VTRS) entered into a definitive agreement to acquire Oyster Point Pharma, Inc. (NasdaqGS:OYST) for approximately $300 million on November 7, 2022. Under the terms of the agreement, Viatris will commence a tender offer to purchase all outstanding shares of Oyster Point Pharma for $11.00 per share in cash at closing, plus a contingent value right (“CVR”) for a potential cash payment of up to $2.00 per share upon achievement of specified performance targets by Oyster Point Pharma for full year 2022. In a related transaction, Viatris Inc. also agreed to acquire Famy Life Sciences. Together, the acquisitions have an aggregate purchase price of approximately $700 million to $750 million which Viatris expects to fund with cash on hand. Following the successful closing of the tender offer, Viatris will acquire all remaining shares of Oyster Point Pharma’s common stock that are not tendered into the tender offer through a second-step merger at the same price of $11.00 per share, plus a CVR representing the right to receive up to $2.00 per share. Oyster Point Pharma stockholders holding approximately 46% of Oyster Point Pharma’s common stock have entered into a tender and support agreement with Viatris, pursuant to which such stockholders have agreed, among other things, to tender 100% of their shares of Oyster Point Pharma’s common stock in the tender offer, subject to the terms and conditions of such agreement. The transaction is subject to customary closing conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, receipt of regulatory approval and tender acceptance of more than 50% of Oyster Point shares. The transaction was unanimously approved by the Oyster Point Pharma Board of Directors. The transaction is anticipated to close during the first quarter of 2023. Centerview Partners LLC is serving as the exclusive financial advisor to Oyster Point Pharma, and Cooley LLP is serving as legal counsel. Citigroup Global Markets Inc. is serving as the exclusive financial advisor to Viatris and Mark I. Greene, Jonathan J. Katz, Amanda Hines Gold, J. Leonard Teti II, Margaret T. Segall, David J. Kappos, Matthew Morreale and Andrew M. Wark of Cravath, Swaine & Moore LLP is serving as legal counsel. Price Target Changed • Nov 08
Price target decreased to US$24.20 Down from US$28.60, the current price target is an average from 5 analysts. New target price is 109% above last closing price of US$11.57. Stock is down 12% over the past year. The company is forecast to post a net loss per share of US$6.32 next year compared to a net loss per share of US$3.87 last year. Aankondiging • Nov 03
Oyster Point Pharma, Inc. to Report Q3, 2022 Results on Nov 10, 2022 Oyster Point Pharma, Inc. announced that they will report Q3, 2022 results on Nov 10, 2022 Aankondiging • Aug 18
Oyster Point Pharma Announces Tyrvaya® to Be Covered by the Larger Medicare Pharmacy Benefit Manager Oyster Point Pharma, Inc. announced that the larger Medicare Pharmacy Benefit Manager in the United States will add TYRVAYA® Nasal Spray on its Medicare Part D formularies, effective September 1, 2022. Major Estimate Revision • Aug 18
Consensus revenue estimates fall by 10% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$35.0m to US$31.4m. Forecast losses increased from -US$6.05 to -US$6.24 per share. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target down from US$30.50 to US$28.60. Share price fell 10% to US$6.90 over the past week. Price Target Changed • Aug 12
Price target decreased to US$28.80 Down from US$32.75, the current price target is an average from 4 analysts. New target price is 311% above last closing price of US$7.01. Stock is down 51% over the past year. The company is forecast to post a net loss per share of US$6.08 next year compared to a net loss per share of US$3.87 last year. Aankondiging • Aug 09
Oyster Point Pharma, Inc. to Report Q2, 2022 Results on Aug 11, 2022 Oyster Point Pharma, Inc. announced that they will report Q2, 2022 results After-Market on Aug 11, 2022 Aankondiging • Jul 28
Oyster Point Pharma Announces Expanded Patient Access to TYRVAYA Oyster Point Pharma, Inc. announced the expansion of patient access to TYRVAYA® (varenicline solution) Nasal Spray and provided an update on the commercial performance of TYRVAYA in the U.S. The Company continues to expand access to TYRVAYA for patients with dry eye disease. As of July 2022, TYRVAYA is now covered by commercial prescription drug plans managed by the nation’s top three Pharmacy Benefit Manager Group Purchasing Organizations. The Company has also introduced in July expanded patient access programs to include more eligible patients. Looking forward, the Company continues to expect to further expand access to TYRVAYA with coverage for Medicare Part D patients in 2023, and as early as the fourth quarter of 2022. The expansion of patient access to TYRVAYA comes as the Company continues to build upon its launch success. Launch to date as of July 1, 2022, TYRVAYA prescriptions have already been written by approximately 7,400 eye care prescribers (ECPs) out of the approximately 21,000 total ECPs targeted by the Company’s field-based sales resources. Based on third-party data, among ECPs who have written a commercial TYRVAYA prescription, TYRVAYA has reached approximately 21% market share1 of commercial new-to-brand prescriptions (NBRx) as of the week ending July 1, 2022, driven by strong utilization among ECPs. Notably, this result was achieved in just eight months since the launch of TYRVAYA in the U.S. Price Target Changed • Jul 19
Price target decreased to US$29.00 Down from US$32.75, the current price target is an average from 4 analysts. New target price is 517% above last closing price of US$4.70. Stock is down 74% over the past year. The company is forecast to post a net loss per share of US$6.10 next year compared to a net loss per share of US$3.87 last year. Seeking Alpha • Jun 30
Oyster Therapeutics: State Of Business Is Confounding OYST has an approved product that is highly competitive against a blockbuster drug.
They seem to have executed commercialization pretty well, except in the bottom line.
Here, they have abysmally failed to make any money.
Oyster Point Pharma, Inc. (OYST) has an approved product, Tyrvaya (OC-01, varenicline solution) Nasal Spray for treating dry eye disease, and it is also in the pipeline for Neurotrophic Keratopathy Stage 1. NK is a rare disease characterized by decreased corneal sensitivity and poor corneal healing. For the pipeline program, the company says in its earnings call:
We continue to enroll patients in our OLYMPIA Phase 2 study of OC-01 nasal spray aimed at treating Stage 1 NK. We remain on track to expect results of this trial in the second half of this year.
Now, coming to the approval, Tyrvaya was approved in October 2021 and started in the market by early November. So this was effectively the first full quarter of reported earnings for Tyrvaya.
Dry eye disease occurs in over 38 million Americans. Current treatment options are Allergan’s Restasis and Shire’s Xiidra; both are given as eye drops. Restasis is a mild immunosuppressant while Xiidra is an anti-inflammatory drug. However, given the formulation that requires giving the medications directly to the eye - always a cumbersome and painful process - compliance is low. Moreover, these therapies take months to work from the onset of treatment. The company says there are 7 million patients that have tried and abandoned the standard therapies.
Tyrvaya uses a completely new delivery method, as well as a unique mechanism of action. It is used as a nasal drop, and it works by triggering the trigeminal nerve which in its turn triggers tear production. In 3 clinical trials in over 1000 patients in mild, moderate and severe dry eye disease - ONSET-1, ONSET-2 and MYSTIC - the drug has demonstrated safety and efficacy. Patients showed statistically significant improvements in tear film production as assessed using the Schirmer's score at Week 4, with more than 50% patients showing optimal tear production compared to about half that number in the placebo group:
TYRVAYA-treated patients showed statistically significant improvements in tear film production as assessed using the anesthetized Schirmer's score (0-35 mm) at Week 4. Of the patients treated with TYRVAYA, 52% achieved ≥10 mm increase in Schirmer's score from baseline in the ONSET-1 study, and 47% achieved ≥10 mm increase in Schirmer's score from baseline in the ONSET-2 study, compared to 14% and 28% of vehicle-treated patients in the ONSET-1 study and the ONSET-2 study, respectively at Week 4 (p<0.01 in both studies). Of the patients treated with TYRVAYA, the mean change in Schirmer's score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle treated patients in the ONSET-1 study and ONSET-2 study, respectively at Week 4.
So the first full quarter revenue is $2.7mn. Around 19,000 prescriptions were filled, and these were written by 4500 unique prescribers. 65% of all patients went for refills. A number of patients have continued using the medicine for 6 months starting from November.
The company has also taken great strides on the mediclaim front. In February, TYRVAYA was placed on Express Scripts National Preferred basic and high performance formularies, which collectively make up around 26 million lives. The company has gone on to add more payers, and now it has commercial coverage for up to approximately 95 million lives, which represents 52% of all U.S. commercial lives.
Financials
OYST has a market cap of $134mn and a cash balance of $144mn. This is a terrible state of affairs. There’s a short interest of 22%, which says that the market still thinks the company is overvalued. For a commercial stage company with a clinically successful drug to be in this sorry state is unnerving for investors. Aankondiging • Jun 29
Oyster Point Pharma, Inc. Announces Management Changes Oyster Point Pharma, Inc. announced that on June 23, 2022, John Snisarenko, the Company’s Chief Commercial Officer, and the Company mutually agreed that Mr. Snisarenko would cease his employment with the Company, effective July 1, 2022. Mr. Snisarenko’s departure is not the result of any disagreement with the Company with respect to any matter relating to the Company’s operations, policies or practices. On June 28, 2022, the Company appointed Daniel Lochner, the Company’s Chief Financial Officer, to serve as the Company’s CFO and Chief Business Officer. Mr. Lochner, age 40, has served as the Company’s CFO since July 2019. Previously, Mr. Lochner was a Managing Director within the Investment Management Division of Goldman Sachs where he served as a lead equity portfolio manager and healthcare investor for various fund strategies. Mr. Lochner joined the Investment Management Division of Goldman Sachs in 2005 as an equity investor, a position he maintained during his tenure at the firm. Mr. Lochner received a B.A. in Economics from the University of Richmond and an Executive M.B.A. from Columbia University. The Company believes that Mr. Lochner is qualified to serve as the Company’s CFO and Chief Business Officer because of his financial and accounting expertise and his experience in the healthcare industry. There is no arrangement or understanding between Mr. Lochner and any other person pursuant to which he was selected as the Chief Business Officer. There are no related party transactions between the Company and Mr. Lochner that are required to be disclosed pursuant to Item 404(a) of Regulation S-K. Price Target Changed • May 07
Price target decreased to US$44.00 Down from US$49.75, the current price target is an average from 3 analysts. New target price is 643% above last closing price of US$5.92. Stock is down 67% over the past year. The company is forecast to post a net loss per share of US$6.18 next year compared to a net loss per share of US$3.87 last year. Aankondiging • May 04
Oyster Point Pharma, Inc. to Report Q1, 2022 Results on May 05, 2022 Oyster Point Pharma, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022 Aankondiging • Apr 23
Oyster Point Pharma, Inc., Annual General Meeting, Jun 03, 2022 Oyster Point Pharma, Inc., Annual General Meeting, Jun 03, 2022, at 08:30 US Eastern Standard Time. Agenda: To elect the nominees Jeffrey Nau, Ph.D., M.M.S., Michael G. Atieh and George Eliades, Ph.D. as Class III directors until the 2025 annual meeting of stockholders or until their respective successor have been elected or appointed; to ratify the appointment of PricewaterhouseCoopers LLP as independent registered public accounting firm for the fiscal year ending December 31, 2022; and to conduct any other business properly brought before the Annual Meeting and any adjournment or postponement thereof. Board Change • Mar 30
High number of new directors Non-Executive Chairperson Don Santel was the last director to join the board, commencing their role in 2021. Major Estimate Revision • Mar 13
Consensus revenue estimates fall by 15% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$36.8m to US$31.2m. Forecast losses increased from -US$6.04 to -US$6.56 per share. Biotechs industry in the US expected to see average net income decline 38% next year. Consensus price target of US$49.75 unchanged from last update. Share price rose 33% to US$11.44 over the past week. Major Estimate Revision • Feb 26
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 expected loss increased from -US$5.32 to -US$6.04 per share. Revenue forecast of US$36.8m unchanged since last update. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$50.25 unchanged from last update. Share price rose 15% to US$10.95 over the past week. Aankondiging • Feb 17
Oyster Point Pharma, Inc. to Report Q4, 2021 Results on Feb 24, 2022 Oyster Point Pharma, Inc. announced that they will report Q4, 2021 results After-Market on Feb 24, 2022 Recent Insider Transactions Derivative • Nov 05
Chief Financial Officer exercised options to buy US$115k worth of stock. On the 1st of November, Daniel Lochner exercised options to buy 9k shares at a strike price of around US$11.51, costing a total of US$99k. This transaction amounted to 22% of their direct individual holding at the time of the trade. Since March 2021, Daniel's direct individual holding has increased from 14.30k shares to 38.41k. Company insiders have collectively bought US$458k more than they sold, via options and on-market transactions, in the last 12 months. Recent Insider Transactions Derivative • Oct 24
President exercised options to buy US$558k worth of stock. On the 21st of October, Jeffrey Nau exercised options to buy 50k shares at a strike price of around US$1.02, costing a total of US$51k. This transaction amounted to 139% of their direct individual holding at the time of the trade. Since March 2021, Jeffrey's direct individual holding has increased from 16.00k shares to 36.00k. Company insiders have collectively bought US$359k more than they sold, via options and on-market transactions, in the last 12 months. Price Target Changed • Oct 19
Price target decreased to US$51.67 Down from US$57.00, the current price target is an average from 3 analysts. New target price is 314% above last closing price of US$12.49. Stock is down 45% over the past year. The company is forecast to post a net loss per share of US$3.93 next year compared to a net loss per share of US$2.92 last year. Recent Insider Transactions Derivative • Sep 08
Chief Financial Officer exercised options to buy US$106k worth of stock. On the 2nd of September, Daniel Lochner exercised options to buy 8k shares at a strike price of around US$11.51, costing a total of US$86k. This transaction amounted to 24% of their direct individual holding at the time of the trade. Since September 2020, Daniel's direct individual holding has increased from 14.30k shares to 30.91k. Company insiders have collectively bought US$354k more than they sold, via options and on-market transactions, in the last 12 months. Major Estimate Revision • Aug 19
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$11.8m to US$6.75m. EPS estimate unchanged at -US$3.92 per share. Biotechs industry in the US expected to see average net income decline 26% next year. Consensus price target down from US$57.00 to US$55.50. Share price fell 3.5% to US$13.95 over the past week. Recent Insider Transactions Derivative • Jul 31
Chief Financial Officer exercised options to buy US$107k worth of stock. On the 28th of July, Daniel Lochner exercised options to buy 8k shares at a strike price of around US$11.51, costing a total of US$86k. This transaction amounted to 32% of their direct individual holding at the time of the trade. Since September 2020, Daniel has owned 14.30k shares directly. Company insiders have collectively bought US$408k more than they sold, via options and on-market transactions, in the last 12 months. Aankondiging • Jul 02
Oyster Point Pharma Announces Preclinical Data Highlighting Potent Activity of OC-01 (varenicline) and OC-02 (simpinicline) Against SARS-CoV-2 Virus and Variants Oyster Point Pharma, Inc. announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease. Administration of OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor agonist, protected rhesus macaques against SARS-CoV-2 nasal infection. The results were published on the preprint server bioRxiv. On Day 1, using a viral infection model and following two administrations of 100 µl of OC-01 (varenicline) nasal spray (0.6 mg/ml varenicline) into each nostril, animals were challenged with a very high viral inoculum (approximately 70 thousand plaque-forming units) of active SARS-CoV-2, via both intranasal (nose) and intratracheal (lung) routes. Animals then received two additional administrations of OC-01 (varenicline) nasal spray into each nostril on Day 1, followed by four times daily for the following four days. Administration of OC-01 (varenicline) nasal spray resulted in inhibition of cellular entry and replication of SARS-CoV-2, illustrated by a decrease of detectable SARS-CoV-2 subgenomic RNA (sgRNA) by approximately 2 logs compared to controls with complete absence in all animals at 3 days and 5 days post-challenge. In control animals treated with the same lot of virus inoculum, nasal swabs reached a peak of approximately 10 million SARS-CoV-2 sgRNA copies within two days of viral challenge and were present throughout the course of the study. The absence of sgRNA indicates that the SARS-CoV-2 virus had not significantly infected nasal mucosa cells to start the transcription process of building new infectious virions. The absence of sgRNA following this very high viral inoculum also suggests the possibility of transmission may be substantially reduced after treatment with OC-01 (varenicline) nasal spray. SARS-CoV-2 has been shown to predominantly enter the human body via nasal epithelial cells1, specifically ciliated and mucous secreting cells of the nasal mucosa2,3. Therefore, the nasal cavity represents a highly susceptible mucosal surface for infection and amplification within the respiratory tree. The nasal cavity also allows for treatment with topical compounds that can be delivered in higher local concentrations with potentially lower systemic exposure that may not be achievable when administered as an oral tablet or IV infusion. In a separate study, in collaboration with the Trudeau Institute, researchers evaluated the in vitro antiviral activity of varenicline against SARS-CoV-2 and SARS-CoV-2 alpha and beta variants using Calu-3 (human airway epithelial cells) and Caco-2 (colon epithelial cells) cell lines. “Varenicline has demonstrated potent antiviral activity against SARS-CoV-2 and variants, alpha and beta, in cell culture. The promising in vitro and in vivo data suggest a clinical path forward for OC-01, which could prove a potential treatment in preventing severe COVID-19 symptoms and the spread of infection. Further studies investigating the mechanism of action and its effect on other variants of concern, such as the gamma and delta variants are ongoing," said Priya Luthra, PhD, Trudeau Institute Principal Investigator. Additionally, OC-02 (simpinicline), a highly selective nicotinic acetylcholine receptor agonist was evaluated for in vitro antiviral activity against the SARS-CoV-2 alpha variant using Calu-3 cell lines. Simpinicline demonstrated potent antiviral activity against the SARS-CoV-2 variants in cell culture with an IC50 of 0.04 µM. Further studies investigating the antiviral effect on other variants of concern are ongoing. Given the results of both the in vivo and in vitro studies, OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray warrant further investigation as an antiviral agent for pre-exposure prophylaxis, post-exposure prophylaxis, and/or prevention of transmission of SARS-CoV-2. Additional in vivo and in vitro studies are ongoing. OC-01 (varenicline) nasal spray and OC-02 (simpinicline) nasal spray have not been proven safe or effective to prevent SARS-CoV-2 infection or treat COVID-19 in humans nor has OC-01 (varenicline) or OC-02 (simpinicline) nasal spray been approved for any use by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021, with a planned U.S. launch in the fourth quarter of 2021, if approved by the FDA. Aankondiging • Jun 30
Oyster Point Pharma, Inc. Provides Key Supply Chain Insight for OC-01 (Varenicline) Nasal Spray Oyster Point Pharma, Inc. announced information regarding a key supply chain insight for OC-01 (varenicline) nasal spray following the announcement that an unrelated manufacturer of varenicline oral tablets has suspended distribution due to impurities discovered in one or more lots of its product. Oyster Point Pharma has not observed any measurable impurities in its OC-01 (varenicline) nasal spray. Oyster Point Pharma is developing OC-01 (varenicline) nasal spray to treat the signs and symptoms of dry eye disease. Oyster Point Pharma currently sources OC-01 (varenicline) nasal spray active pharmaceutical ingredient (API), varenicline tartrate, from a supplier unrelated to the manufacturer that has suspended distribution due to nitrosamine being above acceptable levels. Oyster Point Pharma takes seriously the quality of products in development and patient safety. To date, Oyster Point Pharma has tested samples of varenicline tartrate API intermediate, multiple lots of varenicline tartrate drug substance used in OC-01 (varenicline) nasal spray finished product, and multiple lots of OC-01 (varenicline) nasal spray finished product with no evidence of nitrosamine levels being above the lower limit of detection from the assay used for measuring presence. The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021, with a planned U.S. launch in the fourth quarter of 2021, if approved by the U.S. Food and Drug Administration (FDA). OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not been established. Aankondiging • Jun 22
Oyster Point Pharma Announces Enrollment of First Subject in the OLYMPIA Phase 2 Clinical Trial of OC-01 (varenicline) Nasal Spray for Patients with Neurotrophic Keratopathy Oyster Point Pharma, Inc. announced enrollment of the first subject in the OLYMPIA Phase 2 clinical trial of OC-01 (varenicline) nasal spray for the treatment of Stage 1 Neurotrophic Keratopathy (NK). The OLYMPIA Phase 2 study is a multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the safety and efficacy of OC-01 (varenicline) nasal spray in subjects with Mackie’s Classification Stage 1 Neurotrophic Keratopathy. The study is expected to enroll approximately 100 subjects at approximately 18 U.S. sites. In this clinical trial, OC-01 (varenicline) nasal spray will be administered three times a day, as compared to placebo (vehicle) nasal spray. The pre-specified primary endpoint of the trial will be the percentage of subjects who achieve complete resolution of fluorescein corneal staining at Day 56. Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases. Aankondiging • Jun 04
Oyster Point Pharma, Inc. Announces Preclinical Study Results and Pipeline Expansion with Enriched Tear Film (ETF™) Gene Therapy to Target Ocular Surface Diseases Oyster Point Pharma, Inc. announced the expansion of its pipeline with the introduction of Enriched Tear Film (ETF™) Gene Therapy and proof-of-concept in vivo study results from its first gene therapy candidate, OC-101. ETF™ Gene Therapy is a proprietary adeno-associated virus (AAV) based gene therapy approach where a target gene is delivered to human lacrimal gland cells via intralacrimal gland injection. Rather than replacing a gene that is defective or missing, a new target gene is delivered that may potentially produce a selected naturally occurring protein, enzyme, or other therapeutic gene product. The goal for this target gene is to produce a selected gene product to change cell behavior and function on the ocular surface. Oyster Point’s investigational drug, OC-01 (varenicline) nasal spray, a highly selective cholinergic agonist, may play a role in ocular surface diseases treated with ETF™ Gene Therapy through its potential to modulate the secretion of a selected gene product. In this proof-of-concept in vivo study evaluating OC-101 (AAV-NGF), a single, intralacrimal gland injection of an AAV containing the human NGF (hNGF) gene resulted in statistically significant levels of hNGF protein being expressed within the lacrimal gland and tear film of a rabbit model, as compared to control. hNGF was secreted into the tear film as early as Day 7, after the intralacrimal gland injection. No control animals showed evidence of hNGF in the lacrimal gland or tear film. Additionally, three weeks following OC-101 (AAV-NGF) transduction of the lacrimal gland, cholinergic activation of the lacrimal gland with OC-01 (varenicline) nasal spray resulted in statistically significant increases in hNGF expression in the tear film, as compared to pre-cholinergic stimulation levels and as compared to control. After cessation of OC-01 (varenicline) nasal spray, hNGF tear protein levels returned to pre-cholinergic activation levels (measured at Day 14). During the 42-day study, there were no macroscopic or microscopic safety findings observed associated with the intralacrimal gland administration of OC-101 (AAV-NGF) or OC-01 (varenicline) nasal spray. Major Estimate Revision • May 13
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 losses forecast to reduce from -US$4.36 to -US$3.86 per share. Revenue forecast unchanged from US$11.8m at last update. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target broadly unchanged at US$57.00. Share price was steady at US$18.03 over the past week. Price Target Changed • May 08
Price target decreased to US$56.33 Down from US$60.75, the current price target is an average from 2 analysts. New target price is 217% above last closing price of US$17.78. Stock is down 47% over the past year. Aankondiging • May 02
Oyster Point Pharma Announces Clinical Data Presentation of OC-01 (varenicline) Nasal Spray for Dry Eye Disease Oyster Point Pharma, Inc. announced the presentation of data analyses from its Phase 3 ONSET-2 clinical trial evaluating OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Virtual Annual Meeting, being held on May 1-5. OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and neurotrophic keratopathy (NK). 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. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film is responsible for forming the primary refracting surface of the eye, as well as protecting and moisturizing the cornea. OC-01 (varenicline) nasal spray is an investigational new drug and has not been approved for any use in any country. The safety and efficacy of OC-01 (varenicline) nasal spray have not previously been established. Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States and is growing in prevalence. An estimated 16 million adults in the U.S. have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies. Aankondiging • Mar 03
Oyster Point Pharma Announces FDA Acceptance for Filing New Drug Application for Oc-01 (Varenicline) Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease Oyster Point Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date for OC-01 (varenicline) nasal spray is October 17, 2021. At present, FDA has stated that it does not intend to hold an advisory committee meeting to discuss this application. The NDA submission was supported by safety and efficacy results from the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials in over 1,000 subjects with mild, moderate or severe symptoms of dry eye disease. In these clinical trials, OC-01 (varenicline) nasal spray demonstrated statistically significant improvements, as compared to control, in Schirmer’s Score (an objective, reproducible, and quantifiable measure of natural tear film production), which was the primary endpoint in all trials. Key secondary endpoints in ONSET-1 and ONSET-2 included change from baseline in symptoms as assessed by eye dryness score. In both of these pivotal trials, there was statistically or nominally statistically significant improvement in symptom scores at Day 28, and in ONSET-2 as early as Day 14, in patients treated with OC-01 (varenicline) nasal spray as compared to control. All doses studied in the clinical trial program were well-tolerated with no serious drug related adverse events. Recent Insider Transactions Derivative • Mar 02
Chief Financial Officer exercised options to buy US$184k worth of stock. On the 24th of February, Daniel Lochner exercised options to buy 9k shares at a strike price of around US$11.51, costing a total of US$105k. This transaction amounted to 64% of their direct individual holding at the time of the trade. Since March 2020, Daniel's direct individual holding has increased from 6.30k shares to 14.30k. Company insiders have collectively bought US$316k more than they sold, via options and on-market transactions, in the last 12 months. Aankondiging • Feb 13
Oyster Point Pharma, Inc. to Report Q4, 2020 Results on Feb 18, 2021 Oyster Point Pharma, Inc. announced that they will report Q4, 2020 results After-Market on Feb 18, 2021 Is New 90 Day High Low • Feb 09
New 90-day high: US$24.64 The company is up 3.0% from its price of US$24.01 on 10 November 2020. The American market is up 16% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 25% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$211 per share. Is New 90 Day High Low • Jan 16
New 90-day low: US$17.92 The company is down 25% from its price of US$23.75 on 16 October 2020. The American market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 19% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$206 per share. Is New 90 Day High Low • Dec 25
New 90-day low: US$18.85 The company is down 1.0% from its price of US$19.08 on 25 September 2020. The American market is up 18% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 23% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$230 per share. Aankondiging • Dec 20
Oyster Point Pharma, Inc. Submits New Drug Application to the U.S. Food and Drug Administration for OC-01 Nasal Spray for the Treatment of Signs and Symptoms of Dry Eye Disease Oyster Point Pharma, Inc. announced it has submitted a 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The NDA submission is supported by safety and efficacy results from the Phase 3 ONSET-2, Phase 2b ONSET-1, and Phase 2 MYSTIC clinical trials in over 1,000 subjects with dry eye disease. The MYSTIC, ONSET-1 and ONSET-2 clinical trials showed statistically significant improvements in Schirmer’s Score (an objective, reproducible, and quantifiable measure of natural tear film production), as compared to control, which was the primary endpoint in all studies. Key secondary endpoints in ONSET-1 and ONSET-2 included change from baseline in symptoms as assessed by eye dryness score. In both of these pivotal studies, there was statistically or nominally statistically significant improvement in symptom scores at Day 28, and in ONSET-2 as early as Day 14, as compared to control. All doses studied in the clinical trial program were well-tolerated with no serious drug related adverse events. Aankondiging • Dec 02
Oyster Point Pharma Submits a Phase 2 Clinical Trial Protocol to Evaluate OC-01 Nasal Spray for Neurotrophic Keratitis (NK) Oyster Point Pharma, Inc. announced it has submitted to the U.S. Food and Drug Administration (FDA) a protocol to initiate a clinical study in adult patients with neurotrophic keratitis (NK), a degenerative disease characterized by decreased corneal sensitivity and poor corneal healing. The submission was made to Oyster Point’s Investigational New Drug (IND) for OC-01 (varenicline) nasal spray in dry eye disease. Enrollment of the first patient in the OLYMPIA Phase 2 study in NK is planned for the first half of 2021. The OLYMPIA Phase 2 trial is a multi-center, randomized, double-masked, placebo-controlled study that will enroll adult subjects with NK. One-half of the adult subjects will receive one dose of OC-01 nasal spray twice daily for eight weeks; the other half will receive a placebo-controlled nasal spray. The study objective is to evaluate the safety and effectiveness of OC-01 nasal spray as compared to placebo for complete resolution of corneal staining in subjects with Stage 1 or Stage 2 NK in one or both eyes. In addition to NK, Oyster Point remains on track to file its new drug application (NDA) for OC-01 to treat the signs and symptoms of dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film, in the fourth quarter of 2020. OC-01 is a highly selective cholinergic agonist being developed as a preservative free nasal spray to treat the signs and symptoms of dry eye disease. 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. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies OC-01 was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film coating is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea. OC-01 nasal spray is an investigational new drug and has not been approved for any indication in any country. The safety and efficacy of OC-01 have not been established. Neurotrophic keratitis (NK), also known as neuroparalytic keratitis or neurotrophic keratopathy, is a disease characterized by decreased corneal sensitivity and poor corneal healing. The most common causes of loss of corneal sensation are viral infection (herpes simplex and herpes zoster keratoconjunctivitis) followed by chemical burns, physical injuries, and corneal surgery. In addition, systemic diseases such as diabetes and multiple sclerosis may decrease sensory nerve function or damage sensory fibers. NK can be classified broadly into three stages: Stage 1 (mild) consists of ocular surface irregularities and reduced vision, Stage 2 (moderate) exhibits a non-healing persistent defect of the corneal epithelium, and Stage 3 (severe) exhibits corneal ulceration, which may progress to corneal melting and perforation. If not adequately addressed, the progression of NK can lead to the loss of the cornea and the need for transplantation. Aankondiging • Nov 14
Oyster Point Pharma Announces Clinical Data Presentations on OC-01 Nasal Spray for Dry Eye Disease At the American Academy of Ophthalmology 2020 Virtual Annual Meeting Oyster Point Pharma, Inc. announced new data from its Phase 2 IMPERIAL clinical trial evaluating OC-01 (varenicline) nasal spray in the treatment of the signs and symptoms of dry eye disease in adults at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting, being held on November 13-15. A single administration of OC-01 nasal spray significantly reduced goblet cell area and perimeter as measured by in vivo confocal microscopy as compared to placebo in subjects with dry eye disease. Goblet cells in the conjunctiva are responsible for releasing mucus and, based on clinical data, may help re-establish tear film homeostasis. OC-01 nasal spray was found to be safe and well-tolerated in the study, with the most commonly reported treatment-related event being sneeze. The single-center, randomized, double-masked, placebo-controlled trial included 18 patients with dry eye disease. The objective of the study was to assess the effect of OC-01 nasal spray on goblet cell alterations by in vivo confocal microscopy (IVCM). IVCM images of the bulbar conjunctiva, the membrane covering the outer surface of the eye, taken prior to and 10 minutes after administration showed that OC-01 significantly reduced goblet cell area and perimeter in dry eye disease, indicating goblet cell degranulation, which releases lubricating mucus. Aankondiging • Oct 30
Oyster Point Pharma, Inc. to Report Q3, 2020 Results on Nov 05, 2020 Oyster Point Pharma, Inc. announced that they will report Q3, 2020 results at 5:00 PM, Eastern Standard Time on Nov 05, 2020 Aankondiging • Oct 10
Oyster Point Pharma Announces Board of Directors Oyster Point Pharma, Inc. announced changes to its Board of Directors, consistent with the company’s strategic evolution in a pivotal year of growth. Effective immediately, Dr. Ali Behbahani, who has served as a member of Oyster Point’s Board of Directors since July 2017, will step into the role of Chairperson of the Board, replacing Dr. Michael Ackermann, who will step down to focus on new company creation and his positions as Chief Executive Officer of Presidio Medical and Chairperson of Tarsus Pharmaceuticals, two earlier-stage healthcare companies. Dr. Ackermann will continue to provide Oyster Point his expertise as an external strategic consultant going forward. Michael Atieh, who most recently served as Executive Vice President and Chief Financial and Business Officer of Ophthotech Corporation (now IVERIC Bio), will join Oyster Point’s Board of Directors and step into the role of Chairperson of the Audit Committee. Mark Murray, who has served as a member of Oyster Point’s Board of Directors since October 2017 and previously as Chief Financial Officer, will transition from Chairperson of the Audit Committee and continue as a member of the board. Is New 90 Day High Low • Sep 23
New 90-day low: US$19.31 The company is down 33% from its price of US$28.97 on 25 June 2020. The American market is up 8.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$194 per share. Aankondiging • Jul 03
Oyster Point Pharma, Inc.(NasdaqGS:OYST) dropped from Russell 3000 Value Index Oyster Point Pharma, Inc.(NasdaqGS:OYST) dropped from Russell 3000 Value Index Aankondiging • Jul 02
Oyster Point Pharma, Inc.(NasdaqGS:OYST) dropped from Russell Microcap Value Index Oyster Point Pharma, Inc.(NasdaqGS:OYST) dropped from Russell Microcap Value Index