09 Feb 3 Stocks To Watch in 2021!
TherapeuticsMD (NASDAQ: TXMD), is a women’s healthcare Company focused on creating novel solutions for challenges encountered by women in areas such as family planning, reproductive health, and menopause management. The Company’s product offerings include Annovera, a progestin/estrogen CHC vaginal birth control ring intended for contraception, family planning, perimonepause, Bijuva, an FDA-approved estradiol and progesterone capsules for treatment of hot flashes/vasomotor symptoms and IMVEXXY (estradiol vaginal inserts) intended for the treatment of dyspareunia (vulvar/vaginal atrophy). The Company also produces branded and generic prescription prenatal vitamins under the vitaMedMD, BocaGreenMD, Prena1, Prena2, Prena1Chew, VitaPearl and VitaTrue brand names.
The Company has launched three products Invexxy, Bijuva and Annovera in the last two years, and has sold over 700,000 units of ANNOVERA, IMVEXXY and BIJUVA, filled by patients in 2020. It had earlier projected a quarterly EBITDA break-even in 2021, however owing to the impact of COVID-19, the same has now been postponed to 1H 2022. TherapeuticsMD has renegotiated minimum net revenue covenants for Q1 and Q2, 2021 to $18M and $22M, with Sixth Street Partners and is on track to achieve $20M in net revenue for Q4,2020.
Market Cap: $665.48M; Current Share Price: 2.34 USD
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TherapauticsMD’s lead product is ANNOVERA that fills a large unmet need for a reversible, long-lasting patient-controlled and procedure-free contraception and has been able to achieve 250,000 branded NuvaRing prescriptions through preferred coverage with one of the top Pharmaceutical Business Managers (PBM). The product receives maximum attention both in terms of sales force engagement and commercial funding. Invexxy is the second in line and will be supported extensively through increased consumer marketing. For 2021, the projected volume for Annovera stands at 57,000 –76,000 as per Company estimates. However, these numbers could be lower due to lower number of prescriber visits on account of COVID-19.
The Company will be using a multi-pronged marketing strategy using media advertising such as display, search and HCP journals, while also employing targeted content in the form of direct mail and call centers. TherapeuticsMD will also target CTV, snapchat and custom partnerships with platforms such as PopSugar to drive visibility. The product is also available through 6 telehealth platforms namely NURX, simple health, plush care to name a few.
Market Cap: $1.35B; Current Share Price: 45.84 USD
Data by YCharts
Cortexyme, a clinical stage pharmaceutical company, is adopting a path breaking, novel disease-modifying therapeutic approach for treating the underlying cause of Alzheimer’s disease and other degenerative diseases. Its lead candidate Atuzaginstat (COR388) is a first-in-class, orally administered virulence factor inhibitor that targets P. gingivalis gingipains, a specific, infectious pathogen found in the brain of Alzheimer’s patients and known to cause neurodegeneration and neuroinflammation in animal models. The company’s lead investigational medicine, COR388, is currently undergoing a phase 2/3 GAIN Trial in patients with mild to moderate Alzheimer’s.
The Company was founded based on the work of Dr.Stephen Dominy, its co-founder and chief scientific officer, who discovered pathogenic bacteria in the brain of those afflicted with Alzheimer’s. This led to the development of the Company’s small molecule program aimed at preventing the progression of the disease.
Cortexyme initiated a Phase 2/3 clinical trial named (GingipAIN Inhibitor for Treatment of Alzheimer’s disease) “GAIN” in April 2019, to test the efficacy of its new investigational medicine COR388, targeting P. gingivalis bacteria. The study has enrolled 643 subjects and has passed futility analysis and will continue to 1-year endpoint based on the recommendations of the independent Data Monitoring Committee (DMC). The co-primary endpoints of the study are mean change in ADAS-Cog 11 and ADCS-ADL from baseline to 48 weeks versus placebo. The topline data from the study is expected to be available by December 2021. Furthermore, the Company is also anticipating results from a periodontal disease clinical study in Q4 2021.
The Study is based on scientific evidence that Porphyromonas gingivalis, or P. gingivalis, hitherto associated with chronic periodontal disease, can cause Alzheimer’s. COR388 has the potential to slow the progression of AD by destroying the toxic proteins, or gingipains, released by P. gingivalis. It is a first-of-its kind trial that is testing a new paradigm in the treatment of Alzheimer’s, as till date amyloid plaques were the center of any study associated with creating a solution for Alzheimer’s. It enjoys composition of matter patent protection until 2035, with more patents pending for approval.
In pre-clinical studies, COR388 has demonstrated the ability to reduce the bacterial load of a P. gingivalis infection, block the production of amyloid beta, reduce neuroinflammation, and protect neurons in the hippocampus, a part of the brain that mediates memory.
The Company announced a pipeline expansion after the successful completion of the GAIN Trial’s interim analysis. Atuzaginstat will be evaluated in a phase 2 PEAK trial for treatment of Parkinson’s disease. In addition, COR588, a novel lysine gingipain inhibitor will advance to clinical trials in Q3 2021.
As per its update, the Company had $184.3 million in cash and investments on a proforma basis at the end of Q4,2020, which it believes is sufficient to fund its operations until 2023.
Market Cap: $781.57M; Current Share Price: 51.73 USD
Data by YCharts
OptimizeRx offers enterprise solutions for digital health communications and care management. The Company has the largest Electronic Health Record (EHR) network, which offers unmatched reach. In addition, the combination of its proprietary algorithms and pertinent data, facilitate creation of patient or provider specific communication, at any point of the care continuum. OptimizeRx’s Hub Specialty Enroll uses an automated patient engagement application to simplify the administration of overly complex dosing regiments, by guiding the patient and the caregiver through the process, with the help of mobile messaging. The Company has so far served over 600 million patients since 2019 and has a reach over 50 percent of the ambulatory market segment.
The Company’s patient adherence application includes offerings such as financial messaging to communicate savings, Enroll Service for Support, Automated Patient Engagement for patient adherence and encouragement. In addition, it offers a copay program with adjudication facility for the physicians, besides a Specialty Hub Enroll services.
OptimizeRx had over 370+ active EHR channels in 2019, along with 18.5 m coupons distributed in 2019. According to estimates, over 90 percent of U.S physicians use EHR daily and spend an average of 5.9 hours every day. This provides the Company with an opportunity to create targeted messages for doctors and has been able to return an impressive 20% return on investment (ROI) for the pharmaceutical companies that are using its services. The Company’s customers include 80 percent of the top 50 pharma brands in the industry such as Merck (NYSE: MRK), Pfizer (NYSE: PFE), Novo Nordisk (NYSE: NVO) and AbbVie (NYSE: NBBV). In addition, its network of healthcare providers consists of aprima, Allscripts, DxWeb, eazyscripts, DrFirst, EvidenceCare, Care360 to name a few.
The Company achieved record revenues of $10.5 Million in Q3,2020, an increase of 110 percent over Q3,2019, and expects to reach $16 Million in Q4,2020. Gross profit stood at $6 Million, a 99 percent increase over the same quarter in 2019. In addition, the Company has cash and cash equivalents of $12 Million as of 30 September 2020. The total value of its enterprise engagements stands at $21 million and is seeing an upward trend, which augurs well for the company as they generate recurring revenue streams. The Company is also looking at a $170 million sales pipeline in 2021.
The Global Electronic Health Record (EHR) Market is estimated to be worth over $ 38.0 Billion by 2025, growing at a CAGR of 5.5 percent from 2019 to 2025, as per a report by Global Market Insights. The growth in the market is due to the increasing spending on reforming the global healthcare sector by government and public healthcare organizations. The rising adoption of information technology and digital health solutions are not only making patient outcomes better but also resulting improved efficiency and healthcare delivery. The industry has a universal relevance and appeal, providing excellent opportunity and growth for the Company to create a global footprint.
The Company is not only consolidating its offering on a single platform but also diversifying into newer markets such as MedTech and specialty drugs through its strategic collaboration with EVERSANA. Its deal with EVERSANA is especially important as the Company could leverage its healthcare education, compliance, and financial messaging solutions for promoting patient adherence and easy adoption of complex biologics. Additionally, the Company has also acquired RMDY Health, which enables it to create a digital therapeutics program and address the needs of a new segment of customers.
With declining direct sales visits and their questionable efficacy as shown by the fact that 55 percent of doctors limit representative access, the Company is poised to leverage its EHR messaging platform, which provides direct access to the physician and will act as an extremely valuable means of communication for pharma companies in the coming days.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
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