–Expects third quarter 2022 preliminary UPNEEQ net product sales of approximately $10. 0 million, representing an increase of 19% over the second quarter 2022–
–Third quarter 2022 net product sales growth contributed to approximately $24. 4 million in sales for the nine months ended September 30, 2022–
–Approximately 3, 500 cumulative unique medical aesthetics practices placed orders for UPNEEQ through the end of the particular third quarter 2022, a 59% increase from the end of the second one fourth 2022–
–Anticipates fourth quarter 2022 UPNEEQ net item sales to grow approximately 20% – 40% over the third one fourth 2022, symbolizing sales of approximately $12 – $14 million–
BRIDGEWATER, N. J., Oct. 18, 2022 (GLOBE NEWSWIRE) — RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL” or the particular “Company”), the specialty pharmaceutical company, today announced preliminary third quarter 2022 net product sales of UPNEEQ ® (oxymetazoline hydrochloride ophthalmic solution), 0. 1%, the first and only U. S. Food and Drug Administration (“FDA”)-approved ophthalmic solution with regard to blepharoptosis, or droopy eyelids, of around $10. 0 million. The Company also announced that from February through September of 2022 it had received orders from approximately 3, 500 cumulative unique medical aesthetics practices. RVL further revised its guidance for internet revenue associated with UPNEEQ regarding the fourth quarter of 2022, indicating an expectation of $12 to $14 million, addressing sequential growth of 20% in order to 40% compared to the third one fourth of 2022.
“We continue to demonstrate UPNEEQ’s potential within the eyecare and healthcare aesthetics markets. During the third quarter of 2022, we expanded the number of medical aesthetics practices that have purchased UPNEEQ with 59% development in the number of providers since the particular end associated with the first quarter. In addition, we are working diligently in order to establish UPNEEQ as an integrated part of healthcare aesthetics methods, which resulted in nearly 1, 000 procedures having re-purchased UPNEEQ by the end of the third one fourth – a good indication from the significant potential opportunity in this market, ” stated Brian Markison, Chief Executive Officer of RVL.
“With our expanded medical aesthetics salesforce now in place since late July and with the growth we have observed since then, we believe that we are well positioned to achieve twenty percent to forty percent quarterly sequential net earnings growth in the fourth quarter of 2022, ” concluded Markison.
Preliminary Financial Information
The financial and operating data for the third one fourth of 2022 is preliminary and may change. This preliminary data has been prepared by, and is the responsibility of, the particular Company’s management and no independent accounting firm has audited, reviewed, compiled or performed any procedures with respect to this preliminary monetary data. There can be no assurance that the Company’s actual results for this quarterly period will not differ from the initial financial plus operating data and such changes could be material. In inclusion, the Company’s estimate of UPNEEQ net income intended for the 3rd quarter associated with 2022 should not be viewed as a substitute for full financial statements for the third quarter of 2022 ready in accordance with U. S. generally accepted accounting standards. Additional information that will be material in order to investors will be provided within the financial claims for the three and nine months ended Sept 30, 2022, and, accordingly, investors should not place undue reliance on the particular limited initial information being provided herein.
Forward Looking Statements
This particular press release includes statements that will express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or even projections regarding future events or future results plus therefore are, or might be deemed to become, “forward-looking statements. ” The particular Company’s actual results may vary significantly from the particular results anticipated in these forward-looking statements, which can usually be identified by the use associated with 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 even comparable terms. These forward-looking statements include all matters that are not historical facts. They include claims regarding the Company’s intentions, values or current expectations concerning, among other things, the results of operations, financial condition, liquidity, prospects, economic guidance, growth plan, strategies, trends and other occasions, particularly relating to sales of UPNEEQ plus FDA and other regulatory applications, approvals and actions, the particular continuation associated with historical trends, our ability to manage costs and service our debt and the sufficiency of our cash balances plus 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 plus expectations disclosed in the particular forward-looking claims we make. Important factors that could cause actual results and occasions to vary materially through those indicated inside the forward-looking statements include the following: UPNEEQ’s capability to reach market acceptance by clinicians in addition to patients; our own ability in order to successfully commercialize UPNEEQ; the customers’ willingness to pay typically the price we charge with regard to UPNEEQ; the results of each of our marketing and sales expenditures; all of our dependence on third-party suppliers and even distributors regarding UPNEEQ; UPNEEQ’s capacity to produce its intended effects; failures of or delays within clinical trials or even other delays in obtaining regulatory approval or commencing gross sales intended for new products; the impact of legal proceedings; and other risks and uncertainties more fully described in the “Risk Factors” section of our Annual Report on Form 10-K filed upon March 30, 2022 and other filings that the Company makes with the Securities plus Exchange Commission. These forward-looking statements speak only as of the time of this release in addition to 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.
IMPORTANT SAFETY INFORMATION
UPNEEQ ® (oxymetazoline hydrochloride ophthalmic solution), 0. 1% is indicated for the treatment of acquired blepharoptosis in adults. WARNINGS AND PRECAUTIONS
Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and even orbital masses. Consideration should be given to these conditions in the particular presence associated with ptosis along with decreased levator muscle function and/or other neurologic signs.
Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients together with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
Use UPNEEQ using caution inside patients having cerebral or even coronary insufficiency or Sjögren’s syndrome. Advise patients to find medical care if signs and symptoms of potentiation of vascular insufficiency develop.
UPNEEQ may increase the risk of angle closure glaucoma in patients by using untreated narrow-angle glaucoma. Recommend patients to get immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
Patients should not touch the tip of typically the single patient-use container in order to their eye or to be able to any surface, in order to avoid eye injury or perhaps contamination regarding the solution.
Adverse reactions that occurred in 1-5% involving subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, vision irritation together with headache.
Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs like betablockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alphan adrenergic receptor antagonists for example in this treatment of cardiovascular disease, or maybe benign prostatic hypertrophy.
Caution is in individuals taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.
About RVL Pharmaceuticals plc
RVL Pharmaceuticals plc is the specialty pharmaceutical company focused about the commercialization of UPNEEQ ® (oxymetazoline hydrochloride ophthalmic solution), 0. 1%, for often the remedying of obtained blepharoptosis, as well as low-lying eyelid, in grown-ups. UPNEEQ is the first non-surgical treatment option approved by the FDA for attained blepharoptosis.
Investor and additionally Media Relations for RVL Pharmaceuticals plc
Lisa M. Wilson
In-Site Communications, Inc.
E: [email protected] com