Consumers Around the Country Turn to Over the Counter Drugs for Relief

NEW YORK, May 22, 2019 /PRNewswire/ -- The lack of accessibility and expensive costs of prescription-based drugs have made it challenging for many consumers to obtain adequate medication. As a result, consumers have begun switching towards over-the-counter or OTC medicines. In the U.S., there was a total of 2.9 billion retail trips recorded per year to purchase OTC products, according to the Consumer Healthcare Products Association (CHPA). On average, a typical American household spends upwards of USD 338 per year on OTC medication as many consumers prefer OTC medications because of their accessibility and affordability. For instance, many pharmacies across the country are open 24 hours a day, which allows customers to purchase medication during the afternoon or even at midnight. The cheaper costs of OTC products have also saved Americans billions of dollars collectively. The CHPA noted that the products have saved Americans nearly USD 77 Billion in clinical cost savings and USD 25 Billion in drug cost savings or a combined total of USD 102 Billion annually. Research suggests that 81% of U.S. adults use OTC medicines as their first response to minor ailments while U.S. consumers on average make approximately 26 trips a year to purchase products. However, consumers only visit the doctor about three times a year on average. The widespread usage highlights the impact the OTC marketplace has on consumers and the national healthcare system. Nearly 27 million Americans said they wouldn't have sought treatment if OTC medications were not readily available at their expense. Additionally, the OTC drug market is primarily being accelerated by product innovations, high penetration in emerging markets and favorable regulatory frameworks. According to data compiled by Mordor Intelligence, the global OTC drug market was valued at USD 303.51 Million in 2018. By 2024, it is estimated to reach USD 491.02 Billion while exhibiting a CAGR of 8.5% during the forecast period from 2019 to 2024. Innovus Pharmaceuticals, Inc. (OTC: INNV), Eli Lilly and Company (NYSE: LLY), Pfizer Inc. (NYSE: PFE), The Church & Dwight Co., Inc. (NYSE: CHD), Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) 

Consumers have over 100,000 options to choose from when it comes to OTC drugs. Typically, medications for respiratory, internal analgesics, heartburn, oral antiseptics, and laxatives account for a large chunk of the market share, according to data by Nielsen. In particular, respiratory drugs accounted for the majority of OTC drug sales as in 2017, upper respiratory OTC retail sales accounted for USD 8.64 Billion out of the total annual sales of USD 34.32 Billion. Overall, respiratory OTC sales dominated the marketplace, followed by heartburn medications as in 2017, heartburn OTC medications accounted for USD 2.65 Billion in retail sales. Aside from minor medical applications, OTC drugs have expanded outwards to treat a diverse pool of conditions. Notably, the market for sexual dysfunction drugs has become an important emerging market within the OTC marketspace. Typically, consumers visit a primary care physician to receive treatment, however, now consumers can easily obtain OTC drugs to treat sexual dysfunction. Predominantly, factors such as age, neurological disease, hormonal imbalance, and diabetes can lead to sexual dysfunctions. Additionally, the erectile dysfunction segment is one of the largest in the sexual dysfunction market. Data compiled by Grand View Research suggests that the erectile dysfunction drug market is expected to reach USD 3.2 Billion by 2022. Collectively, the abundance and accessibility of OTC drugs are expected to further fuel the overall OTC market. "OTC medications are vital to our health care system and are the most prevalent method used to treat the majority of common health problems in the United States," said Kathleen Kenny, PharmaD, RPH, President and Chief Executive Officer of Med Ink Exec, LLC. "General benefits of using OTC pain medications include direct, rapid access to medications. These medications can be found at pharmacies and grocery stores around the clock, seven days a week. The benefits also include fewer physician visits, resulting in reduced health care system costs."

Innovus Pharmaceuticals, Inc. (OTCQB: INNV) announced earlier last week the, "results for the three months ended March 31, 2019.

Financial highlights for the three months ended March 31, 2019 compared to March 31, 2018 included:

• Revenues of approximately $5.4 million, an increase of $0.8 million or 18.0% compared to prior year and $0.6 million or 12.8% compared to the prior quarter;
• Sales & marketing expense as a percentage of total revenue declined to 48.4% compared with 72.7% in prior year;
• Annual product subscription and outbound concierge net revenue of $1.1 million compared to $0.6 million in the prior year or a 98.2% increase;
• Completed $3.17 million private placement;
• Cash used in operations of $0.6 million compared with $0.7 million in the prior year;
• Company's cash and merchant processor holdback position as of May 13, 2019 was $2.9 million; and
• Annual 2019 net revenue projected to achieve record levels of $26-28 million.

2019 First Quarter and Recent Corporate Progress

• Acquired assets of PrimeSavingsClub.com adding another revenue channel with recent historical annual revenues of $2.5 million;
• Diversified revenue channels resulting in approximately 30% of revenue derived from e-commerce platforms;
• Announced the FDA Approval of new ANDA for supply of Fluticare which provides the Company with two suppliers of the product and the opportunity to use the dossier for international filings;
• Obtained approval of four products: Diabasens®, BH® Testosterone Booster, Xyralid® and RecalMax™ in Canada;
• Completed reverse stock split with an intention to potentially up list to Nasdaq;
• International partner, Lavasta Pharma receives approval from Algeria to market and sell Zestra® and Zestra Glide® and received a purchase order for $186,000;
• Announced a second partnered US ANDA for Minoxidil 5% Foam for men and women to be sold under the name Regoxidine™; and
• Launched first hemp-derived Cannabidiol product with MZS Sleeping Aid™.

"We are encouraged by our start to the 2019 year with revenues increasing 18% and 12.8% in the comparable quarter in the prior year and the previous quarter, respectively. The Company has been able to strategically diversify its revenue channels during the quarter without significant disruption to overall revenue and achieving revenues from e-commerce platforms by approximately 30%. Additionally, with twelve products now approved by Health Canada, we are poised to focus more marketing efforts in Canada where we have historically experienced superior returns which we believe will help us achieve our goal of profitability," stated Bassam Damaj, President and Chief Executive Officer of Innovus Pharma…

About Innovus Pharmaceuticals, Inc: Headquartered in San Diego, Innovus Pharma is an emerging OTC consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and consumer care products to improve men's and women's health and vitality and respiratory diseases. Innovus Pharma delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines and consumer and health products, which we market directly, (b) commercial partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our on-line channels, retailers and wholesalers. The Company is dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application ("ANDA") products. The Company is actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC."

Eli Lilly and Company (NYSE: LLY) is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. Eli Lilly and Company recently announced financial results for the fourth quarter and full year of 2018. In the fourth quarter of 2018, worldwide revenue was USD 6.439 Billion, an increase of 5% compared with the fourth quarter of 2017. The increase in revenue was driven by an 11% increase due to volume, partially offset by a 5% decrease due to lower realized prices and a 1% decrease due to the unfavorable impact of foreign exchange rates. Revenue in the U.S. increased 7%, to USD 3.664 Billion, driven by increased volume, partially offset by lower realized prices, primarily in the diabetes portfolio. U.S. volume growth of 12% was driven by newer pharmaceutical products, including Trulicity®, Taltz and Basaglar®, partially offset by decreased volume for products that have lost exclusivity, including Cialis® and Effient®. "Lilly's performance in the fourth quarter of 2018 capped an important year for the company, as we continued to launch new medicines, invest in our pipeline and deliver solid financial results," said David A. Ricks, Lilly's chairman and Chief Executive Officer. "The portfolio of medicines that we have launched over the past five years is providing a strong foundation on which to grow our business, while the pending acquisition of Loxo Oncologyis the latest example of our commitment to develop new medicines that will transform the care of many serious illnesses. We are determined to raise the bar even higher in 2019 so that more people around the world can benefit from Lilly medicines."

Pfizer Inc. (NYSE: PFE) applies science and its global resources to bring therapies to people that extend and significantly improve their lives. Pfizer Inc. recently reported its financial results for first-quarter 2019 and raised the midpoint of its 2019 financial guidance for adjusted diluted EPS. At the start of the 2019 fiscal year, Pfizer reorganized its commercial operations into three businesses: Pfizer Biopharmaceuticals Group (Biopharma), a science-based innovative medicines business, which includes all of the previous Innovative Health business units (except Consumer Healthcare) as well as a new Hospital business unit that commercializes Pfizer's global portfolio of sterile injectable and anti-infective medicines and includes Pfizer's contract manufacturing operation, Pfizer CentreOne. Pfizer also incorporated its biosimilar portfolio into its Oncology and Inflammation & Immunology business units and certain legacy established products into the Internal Medicine business unit. Upjohn, a global, off-patent branded and generic established medicines business, which includes 20 off-patent solid oral dose legacy brands including Lyrica, Lipitor, Norvasc, Viagra and Celebrex, as well as certain generic medicines. Consumer Healthcare, which includes Pfizer's over-the-counter medicines. First-quarter 2019 Upjohn revenues totaled USD 3.1 Billion, up 1% operationally, reflecting: 25% operational growth in emerging markets, driven by strong, volume-driven operational growth in China, primarily from Lipitor, Norvasc and Celebrex; and 10% operational growth in Japan, primarily driven by strong volume growth from Lyrica and Celebrex, partially offset by: 13% operational decline in developed markets excluding Japan, primarily driven by lower revenues for: – Viagra and Upjohn's authorized generic for Viagra in the U.S. resulting from increased generic competition following Viagra's December 2017 patent expiration. Dr. Albert Bourla, Pfizer's Chief Executive Officer, stated, "Our first-quarter 2019 financial results were strong, driven by continued strength from certain Biopharma brands, primarily Eliquis, Ibrance, Prevnar 13/Prevenar 13 and Xeljanz, as well as strong operational growth from certain Upjohn brands, primarily in China. Our new commercial structure is designed to maximize today's revenue growth opportunities while transitioning the company to a period post-2020 where we expect sustained mid-single-digit operational revenue growth through 2025. We remain focused on executing on our commercial strategies, managing expenses, advancing our pipeline and prudently allocating our capital to position Pfizer for sustainable success.

The Church & Dwight Co., Inc. (NYSE: CHD) founded in 1846, is the leading U.S. producer of sodium bicarbonate, popularly known as baking soda. Church & Dwight Co., Inc. recently announced first quarter 2019 EPS of USD 0.70, an 11.1% increase, exceeding the Company's outlook. First quarter net sales grew 3.8% to USD 1,044.7 Million. Organic sales grew 4.5% driven by global consumer products growth of 5.2% which was driven by volume growth of 2.7% and positive product mix and pricing of 2.5%. Consumer Domestic net sales were USD 784.9 Million, a USD 33.5 Million or 4.5% increase driven by household and personal care sales growth. Organic sales increased 4.5% due to higher volume (+1.0%) and positive price and product mix (+3.5%). Growth was led by ARM & HAMMER liquid and unit dose laundry detergent, ARM & HAMMER clumping cat litter, TROJAN condoms, XTRA liquid laundry detergent, L'IL CRITTERS gummy vitamins, and BATISTE dry shampoo. Matthew Farrell, Chief Executive Officer, commented, "Q1 organic sales growth of 4.5% was exceptionally strong and exceeded our 3.5% to 4.0% outlook. Q1 was the fourth consecutive quarter of greater than 4% organic growth and the third consecutive quarter of positive price and product mix (+2.3%). Pricing actions successfully executed late in 2018 contributed to gross margin expansion. Our categories continue to grow and our market shares are healthy. Ten of our 14 domestic categories grew during the quarter and more than half have grown for at least 6 consecutive quarters. In the domestic business, 8 out of 11 power brands met or exceeded category growth in the first quarter. The international business continues to perform strongly with sales growth of 3.3% and organic growth of +8.5%."

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) has been developing and producing medicines to improve people's lives for more than a century. Teva Pharmaceutical Industries Ltd., announced last year the exclusive launch of a generic version of Viagra® (sildenafil citrate) tablets in the U.S. Sildenafil tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). Teva is also offering wraparound services to support patients, such as a sildenafil tablets savings card with which people who meet certain requirements are eligible to participate in the program and may pay as little as USD 0 out-of-pocket with a maximum benefit of up to USD 100 per fill, for up to six sildenafil tablets prescriptions. "The launch of Teva's sildenafil tablets brings an affordable generic treatment option to the estimated 18 million men in the U.S. who are diagnosed with erectile dysfunction," said Brendan O'Grady, Executive Vice President, North America Commercial at Teva. "Our team has made it a priority to ensure that patients are able to access this medicine—through both traditional and more innovative channels."

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