TherapeuticsMD
TherapeuticsMD (TXMD) was incorporated in Utah in 1907 under the name Croff Mining Company, or Croff. Prior to 2008, Croff’s operations consisted entirely of oil and natural gas leases. Due to a spin-off of its operations in December 2007, Croff had no business operations or revenue source and had reduced its operations to a minimal level although it continued to file reports required under the Securities Exchange Act of 1934, or the Exchange Act. As a result of the spin-off, Croff was a “shell company” under the rules of the Securities and Exchange Commission, or the SEC. In July 2009, Croff 
closed a transaction to acquire America’s Minority Health Network, Inc. as a wholly owned subsidiary, (ii) ceased being a shell company, and (iii) experienced a change in control in which the former stockholders of America’s Minority Health Network, Inc. acquired control of its company. On June 11, 2010, the company closed a transaction to acquire Spectrum Health Network, Inc. as a wholly owned subsidiary. On July 20, 2010, the company filed Articles of Conversion and Articles of Incorporation to redomicile in the state of Nevada. On July 31, 2010, the company transferred the assets of America’s Minority Health Network, Inc. to a secured noteholder in exchange for the satisfaction of certain associated debt. On February 15, 2011, the company transferred the assets of Spectrum Health Network, Inc. to a secured noteholder in exchange for the satisfaction of associated debt and in exchange for a licensing agreement under which the company subsequently sold subscription services and advertising on the Spectrum Health Network for commissions.1
On October 3, 2011, the company changed its name to TherapeuticsMD, Inc. On October 4, 2011, the company closed a reverse merger with VitaMedMD pursuant to which (1) all outstanding membership units of VitaMed were exchanged for shares of its common stock, (2) all outstanding VitaMed options and warrants were exchanged and converted into options and warrants to purchase shares of its common stock, and (3) VitaMed became its wholly owned subsidiary. As of December 31, 2011, the company determined that VitaMed would become the sole focus of its company and services previously performed relative to the licensing agreement discussed in the following paragraph were discontinued.
Business Overview
TherapeuticsMD is a women’s health care company focused on creating and commercializing products targeted exclusively for women. Currently, TherapeuticsMD is focused on pursuing the regulatory approvals and pre-commercialization activities necessary for commercialization of its advanced hormone therapy pharmaceutical products. The company's drug candidates that have completed clinical trials are designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies, including hot flashes and vaginal discomfort. TherapeuticsMD is developing these hormone therapy drug candidates, which contain estradiol and progesterone alone or in combination, with the aim of demonstrating clinical efficacy at lower doses, thereby enabling an enhanced side-effect profile compared with competing products. With its SYMBODA™ technology, TherapeuticsMD is developing advanced hormone therapy pharmaceutical products to enable delivery of bio-identical hormones through a variety of dosage forms and administration routes. In addition, the company manufacture and distribute branded and generic prescription prenatal vitamins.
TherapeuticsMD has submitted two new drug applications, or NDAs, to the U.S. Food and Drug Administration, or FDA. In December 2017, the company submitted its NDA for TX-001HR, its bio-identical hormone therapy combination of 17ß- estradiol and progesterone in a single, oral softgel drug candidate, for the treatment of moderate to severe vasomotor symptoms, or VMS, due to menopause in menopausal women with an intact uterus. In November 2017, the company re-submitted its NDA for TX-004HR, its applicator-free vaginal estradiol softgel drug candidate for the treatment of moderate to severe dyspareunia (vaginal pain during sexual intercourse), a symptom of vulvar and vaginal atrophy, or VVA, in menopausal women with vaginal linings that do not receive enough estrogen. The NDA for its TX-004HR drug candidate has a Prescription Drug User Fee Act, or PDUFA, target action date for the completion of the FDA’s review of May 29, 2018 and, if approved on that date, the drug candidate could be launched as early as the third quarter of 2018. If the NDA for TX-001HR is accepted by the FDA, it could be approved as soon as the fourth quarter of 2018 and launched in 2019. The company intend to leverage and grow its current marketing and sales organization to commercialize its advanced hormone therapy drug candidates in the United States assuming the successful completion of the FDA regulatory process. The company believe that its national sales force has developed strong relationships in the OB/GYN market to sell its current prescription prenatal vitamin products and that by delivering additional products through the same sales channel the company can leverage its already deployed assets.
Hormone Therapy Market
The menopause hormone therapy market includes two major components: an FDA-approved drug market and a non-FDA approved drug market supplied by compounding pharmacies. On November 27, 2013, the Drug Quality and Security Act of 2013, or the DQSA, became law and the FDA was given additional oversight over compounding pharmacies. The company believe FDA-approved products are easily measured and monitored, while non-FDA approved hormone therapy drug products, typically referred to as bioidenticals when produced and sold by compounding pharmacies, are not easily measured or monitored. The company estimate the sales of non-FDA approved compounded bioidentical hormone therapy combinations of estradiol and progesterone products by compounding pharmacies approximate $1.5 billion per year. According to PHASTTM Prescription from Symphony Health IVD, or Symphony Heath Solutions, the market for FDA-approved hormone therapy products for the treatment of menopause symptoms or prevention of osteoporosis approximated $4.7 billion based on 2017 sales. The company's phase 3 clinical trials were intended to establish an indication of the safety and efficacy of its hormone therapy drug candidates at specific dosage levels. The company intend its hormone therapy drug candidates, if approved, to provide hormone therapies with well characterized safety and efficacy profiles that can be consistently manufactured to target specifications. This would provide an alternative to the non-FDA approved compounded bioidentical market. This is based on its belief that its drug candidates will offer advantages in terms of demonstrated safety and efficacy, consistency in the hormone dose, lower patient cost as a result of insurance coverage, and improved access as a result of availability from major retail pharmacy chains rather than custom order or formulation by individual compounders.
Pipeline of its Hormone Therapy Drug Candidates
TX-001HR
TX-001HR is its bio-identical hormone therapy combination of 17ß- estradiol and progesterone in a single, oral softgel drug candidate for the treatment of moderate to severe VMS due to menopause, including hot flashes, night sweats and sleep disturbances in menopausal women with an intact uterus. The hormone therapy drug candidate is bioidentical to – or having the same chemical and molecular structure as - the hormones that naturally occur in a woman’s body, namely estradiol and progesterone, and is being studied as a continuous-combined regimen, in which the combination of estrogen and progesterone are taken together in one product daily. If approved by the FDA, the company believe this would represent the first time a combination product of estradiol and progesterone bioidentical to the estradiol and progesterone produced by the ovaries would be approved for use in a single combined product. According to Symphony Health Solutions, sales of FDA-approved combinations of estrogen and progestins were approximately $588 million and sales of estradiol and progesterone on a stand-alone basis were approximately $952 million and approximately $404 million, respectively, in the United States for the 12 months ended December 31, 2017. In December 2016, the company announced positive top-line results from the recently completed REPLENISH Trial, its phase 3 clinical trial of TX-001HR, and on December 28, 2017 the company submitted an NDA for TX-001HR with the FDA. Assuming that the NDA is accepted 74 days thereafter and an FDA review period of ten months from the receipt date to the PDUFA date for a non-new molecular entity, the NDA for TX-001HR could be approved by the FDA as soon as the fourth quarter of 2018.
TX-002HR
TX-002HR is a natural progesterone formulation for the treatment of secondary amenorrhea without the potentially allergenic component of peanut oil. The hormone therapy drug candidate is bioidentical to – or having the same chemical and molecular structure as - the hormones that naturally occur in a woman’s body. In July 2014, the company suspended enrollment and in October 2014 the company stopped the SPRY Trial, its phase 3 clinical trial for TX-002HR, to update the phase 3 protocol based on discussions with the FDA. The company's Investigational New Drug Application, or IND, related to TX-002HR is currently in inactive status. TherapeuticsMD has currently suspended further development of this drug candidate to prioritize its leading drug candidates.
TX-003HR
TX-003HR is a natural estradiol formulation. This hormone therapy drug candidate is bioidentical to the hormones that naturally occur in a woman’s body. The company currently do not have plans to further develop this hormone therapy drug candidate. The company's IND related to TX-003HR is currently inactive.
TX-004HR
TX-004HR is its applicator-free vaginal estradiol softgel drug candidate for the treatment of dyspareunia, a symptom of VVA in menopausal women with vaginal linings that do not receive enough estrogen. The company believe that its drug candidate will be at least as effective as the traditional treatments for VVA because of an early onset of action with less systemic exposure, and it will have an added advantage of being a simple, easier to use dosage form versus traditional VVA treatments. According to Symphony Health Solutions, sales of FDA-approved products for VVA treatment were approximately $1.8 million in the United States for the 12 months ended December 31, 2017. In December 2015, the company announced positive top-line results from the REJOICE Trial, its phase 3 clinical trial of TX-004HR. In November 2017, the company re-submitted its NDA for TX-004HR. The NDA has a PDUFA target action date for the completion of the FDA’s review of May 29, 2018, and, if approved on that date, the drug candidate could be launched as early as the third quarter of 2018.
Preclinical Development
Based upon leveraging its SYMBODATM hormone technology, TherapeuticsMD has four preclinical projects that include development of a progesterone-alone and combination estradiol and progesterone products in a topical cream form, which the company refer to as TX-005HR and TX-006HR, respectively, and transdermal patch form, which the company refer to as TX-007HR and TX-008HR, respectively. The company completed a proof-of-concept preclinical study of TX-005HR in 32 rats. The study used four groups of eight female ovariectomized rats, each of whom were treated with subcutaneous injections of estradiol for eight days. On day four of treatment, they were also dosed with a placebo, subcutaneous injections of progesterone or a similar dose of TX-005HR topical progesterone cream. The results, presented at North American Menopause Society, or NAMS, meeting in October 2015, showed that the progesterone in TX-005HR penetrated the skin and opposed the effect of subcutaneous estradiol on the endometrium. In the fourth quarter of 2016, the company submitted an IND application for TX-006HR, its combination estradiol and progesterone drug candidate in a topical cream form, and intend to commence phase 1 clinical trials of this drug candidate as early as 2018. The company may in the future engage with a financing partner to advance its topical cream and transdermal patch projects. TherapeuticsMD has recently conducted rat bioavailability studies on several novel, oral formulations of progesterone. TherapeuticsMD is currently adapting this formulation for the inclusion of estradiol and have embarked on its development as TX-009HR. In addition to menopausal treatments, TherapeuticsMD is also evaluating various other indications for its hormone technology, including contraception and premature ovarian failure.
Current Products
As the company continue the clinical development of its hormone therapy drug candidates, the company continue to manufacture and distribute its prescription product lines, consisting of prenatal vitamins under its vitaMedMD® brand name and authorized generic formulations of some of its prescription prenatal vitamin products under its BocaGreenMD® Prena1 name. All of its prenatal vitamins are gluten-, sugar-, and lactose-free. A prenatal vitamin option that is both vegan and kosher is also available for women with special dietary needs. The company believe its product attributes result in greater consumer acceptance and satisfaction than competitive products while offering the highest quality and patented ingredients. As of January 1, 2017, the company decided to focus on selling its prescription vitamins and ceased manufacturing and distributing its over-the-counter, or OTC, product lines, except for Iron 21/7 which the company ceased manufacturing and distributing in October 2017. The sales of discontinued products have declined steadily over time resulting in immaterial sales.
Industry and Market
Health Care and Pharmaceutical Market
According to the EvaluatePharma® World Preview 2017, Outlook to 2022 report, despite the global pharmaceutical industry facing pricing and market access concerns, worldwide prescription drug sales are expected to reach approximately $1.1 trillion by 2022, which would represent a compound annual growth rate of approximately 6.5% between 2017 and 2022. New drug approvals in 2016 dropped to 27 (consisting of new molecular entities and biologics), down 50%, as compared to the record high of 56 approvals in 2015. A positive drug approval trend was observed in the first months of 2017 with 21 novel drugs already approved as compared to 15 drugs approved up to May 2016, suggesting that the decline in approvals in 2016 was mostly due to timing of approvals rather than more structural dynamics. There were 51 new drugs (consisting of new molecular entities and biologics) approved by FDA in 2014. The value of these drugs continues to be high, and with U.S. five years post-launch sales of the new drugs approved in 2016, 2015 and 2014 forecast to be over $14 billion, $30 billion, $23 billion, respectively.
Women’s Health Care Market
According to the BBC Research report “Therapeutics for Women’s Health: Technologies and Global Markets,” menopause, post-menopause osteoporosis, endometriosis, breast cancer and polycystic ovary syndrome (PCOS) are the most common issues within women’s health and the U.S. women’s health therapeutics market will grow from nearly $19.5 billion in 2015 to $25.3 billion by 2020, rising at compound annual growth rate of 5.4%. According to the GBI Research (a provider of industry-leading business intelligence solutions on a global basis) report “Women’s Health Therapeutic Market through 2018,” the women’s health therapeutics market is one of the most attractive markets in the global pharmaceutical industry. Hormone therapy, gynecological disorders, and musculoskeletal disorders in women are the prime areas of focus in the women’s health therapeutics market.
Hormone Therapy Market
Menopause is the spontaneous and permanent cessation of menstruation, which naturally occurs in most women between the ages of 40 and 58. It is defined as the final menstrual period and is confirmed when a woman has not had her period for 12 consecutive months. Hormone therapy is the most effective treatment in the United States and Canada for relief of menopausal symptoms according to NAMS. These symptoms are caused by the reduced levels of circulating estrogen as ovarian production shuts down. The symptoms include hot flashes, night sweats, sleep disturbances, and vaginal dryness. According to Symphony Health Solutions, prescriptions for FDA-approved hormone therapy products for the treatment of menopause symptoms or prevention of osteoporosis generated total U.S. sales of over $4.7 billion on over 30 million prescriptions for the 12 months ended December 31, 2017, of which prescriptions for oral hormone therapy accounted for approximately $2.0 billion in U.S. sales on 20 million prescriptions over the same time period.
Prescriptions for menopausal hormone therapy in the United States dropped significantly following the Women’s Health Initiative, or WHI, study in 2002, which found that subjects using conjugated equine estrogens plus the synthetic progestin medroxyprogesterone acetate had, among other things, a greater incidence of coronary heart disease, breast cancer, stroke, and pulmonary embolism. A number of additional studies regarding the benefits and risks of hormone therapy have been conducted over the last decade since the WHI results were first published. In general, recommendations for hormone therapy use are to be judged on an individual basis, and the FDA recommends that women with moderate to severe menopausal symptoms who want to try menopausal hormone therapy for relief use it for the shortest time needed and at the lowest effective dose.
There were approximately 41.7 million women in the United States between the ages of 45 and 64 in 2010, projected to increase slightly by 2.8% to 42.9 million in 2015 and to approximately 44.3 million in 2040, according to the 2010 National Census population figures. These women are the target market for hormone therapy to treat menopausal related symptoms.
Hormone Therapy Products
Estrogen (with or without a progestin) is the most effective treatment of VMS and VVA due to menopause according to NAMS. According to Symphony Health Solutions, total U.S. sales of FDA-approved oral, transdermal, and suppository estrogen (with and without a progestin) hormone therapy products were approximately $4.0 billion for the 12 months ended December 31, 2017. The three primary hormone therapy products are estrogen, progestin, and combination of estrogen and progestin, which are produced in a variety of forms, including oral tablets or capsules, skin patches, gels, emulsion, or vaginal suppositories and creams.
Estrogen-Only Therapies
Estrogen therapies are used to treat VMS due to menopause that are a direct result of the decline in estrogen levels associated with ovarian shutdown at menopause. Estrogen therapy has been used to manage these symptoms for more than 50 years. Estrogen is a generic term for any substance, natural or synthetic, that exerts biological effects characteristic of estrogenic hormones, such as estradiol, a natural ovarian produced estrogen. Based upon the age demographic for all women receiving prescriptions for estrogen therapy and the average age range during which women experience VMS, the company believe that estrogen is primarily used for the treatment of VMS, but also is prescribed for the prevention of osteoporosis.
Estrogen-only therapy, or ET, is used primarily in women who have had a hysterectomy and/or have undergone surgical menopause, as those women do not require a progestin to protect the uterine endometrium. Approximately 433,000 women undergo a hysterectomy each year in the United States according to the United States Centers for Disease Control and Prevention. ET is also used for the treatment of VVA, which has a variety of indications, including dyspareunia (painful intercourse), vaginal dryness, vaginal itching and irritation, painful urination, and other symptoms.
ET is also approved for the prevention of osteoporosis. Multiple studies conducted on various estrogen compositions, including studies published in the Journal of the American Medical Association in 2002, Osteoporosis International in 2000, The Lancet in 2002, Maturitas in 2008, and Climacteric in 2005, suggested efficacy based on increases in bone mineral density. Epidemiological and some fracture prevention studies, such as the study published in the New England Journal of Medicine in 1980, also have suggested a decrease in bone fractures as a result of ET.
According to Symphony Health Solutions, total FDA-approved ET only U.S. sales amounted to $2.8 billion, of which $1.8 billion was specifically used for the treatment of VVA, for the 12 months ended December 31, 2017.
Progestin-Only Therapies
Progestins include the naturally occurring hormone progesterone and a number of synthetic progestin compounds that have progestational activity. These agents are used for a variety of indications and conditions, but most often, progestins are used either alone or in combination with an estrogen for hormonal contraception and to prevent endometrial hyperplasia from unopposed estrogen in hormone therapy. Progestins alone are also used to treat women with secondary amenorrhea in order to create withdrawal bleeding in these women who have not had regular menses. Progestins are also used to treat dysfunctional uterine bleeding and endometriosis. Progesterone has also been used to prevent threatened or recurrent pregnancy loss and for the prevention of preterm birth. Progestins have also been used in fertility treatments. Progestins have also been used as a palliative measure for metastatic endometrial carcinoma and in the treatment of renal and breast carcinoma.
Estrogen/Progestin Combination Products
Progestins are used in combination with estrogen in menopausal women with uteruses to avoid an increase in the incidence of endometrial hyperplasia, which is a condition caused by chronic use of estrogen alone by a woman with a uterus and is associated with an increased incidence of uterine, or endometrial, cancer. Studies have shown that, after one year, the incidence of endometrial hyperplasia is less than 1% in women taking estrogen/progestin combinations, in contrast to up to 20% in women taking estrogen alone. In accordance with FDA recommendations, doctors typically recommend that a menopausal or post-menopausal woman who has a uterus take estrogen plus a progestin, either as a combination drug or as two separate drugs. Symphony Health Solutions estimates that sales of FDA-approved combinations of estrogen and progestins were approximately $588 million and the sales of estradiol and progesterone on a stand-alone basis were approximately $952 million and approximately $404 million, respectively, in the United States for the 12 months ended December 31, 2017.
Limitations of Existing Estrogen/Progestin Therapies
The most commonly prescribed progestin is a synthetic progestin (medroxyprogesterone acetate), which can cause some women to experience painful vaginal bleeding, breast tenderness, and bloating and may reduce cardio-protective benefits potentially associated with estrogen therapy by limiting the estrogen’s ability to raise high-density lipoprotein cholesterol, or good cholesterol, and low-density lipoprotein, or bad cholesterol. A widely prescribed naturally occurring progesterone is known as Prometrium® (progesterone USP). The brand is marketed by AbbVie Inc., and generic versions have been available since 2012. Natural progesterone is used in combination with estrogen for hormone therapy; however, the company believe there are currently no FDA-approved hormone therapy combination products with natural progesterone.
Prenatal Vitamin Market
According to the Centers for Disease Control and Prevention, there are approximately four million births per year in the U.S. Of women giving birth in the U.S., the U.S. Department of Health and Human Services reports that approximately 73% received early prenatal care in the first trimester, while 6% began prenatal care in the third trimester or did not receive any prenatal care. Most doctors encourage taking a prenatal vitamin as the recommended standard of care. Prenatal vitamins are dietary supplements intended to be taken before and during pregnancy and during postnatal lactation that provide nutrients recognized by various health organizations as helpful for a healthy pregnancy outcome.
There are hundreds of prenatal vitamins available, with both prescription and OTC choices. According to Symphony Health Solutions, during the 12 months ended December 31, 2017, approximately 6.2 million prescriptions for prenatal vitamins were issued in the United States resulting in total sales of approximately $379 million, with sales between branded and generic products split nearly evenly.
Business Model
TherapeuticsMD is a women’s health care company focused on creating and commercializing products exclusively for women, including products specifically for pregnancy, childbirth, nursing, pre-menopause, and menopause. TherapeuticsMD has utilized its current product lines as the foundation of its business platform. If approved and commercialized, its hormone therapy drug candidates will allow it to enter the $4.7 billion market for FDA-approved hormone therapy products for the treatment of menopause symptoms or prevention of osteoporosis, based on 2017 total U.S. sales of the hormone therapy market, according to Symphony Health Solutions.
The company's current product line is marketed and sold by a direct national sales force that calls on health care providers in the OB/GYN market space. The company market its prescription prenatal vitamins under its vitaMedMD brand name and authorized generic formulations of its prescription prenatal vitamin products under its BocaGreenMD Prena1 brand name. The company believe that its vitaMedMD brand name has become a recognized name for high quality women’s health care, while its BocaGreenMD products provide physicians, women, and payors with a lower Wholesale Acquisition Cost (WAC) alternative for prenatal vitamins. The company intend to leverage its existing relationships and distribution system to introduce its hormone therapy drug candidates, if approved, which the company believe will enable it to provide a comprehensive line of women’s health care products all under one brand. As of January 1, 2017, the company decided to focus on selling its prescription vitamins and ceased manufacturing and distributing its OTC product lines, except for Iron 21/7 which the company ceased manufacturing and distributing in October 2017. The sales of discontinued products have declined steadily over time resulting in immaterial sales.
The company's sales model focuses on the “4Ps”: patient, provider, pharmacist, and payor. The company market and sell its current products primarily through a direct national sales force of approximately 50 full-time professionals that calls on health care providers in the OB/GYN market space. In addition, its products allow health care providers to offer an alternative to patients to meet their individual nutritional and financial requirements related to co-payment and cost-of-care considerations and help patients realize cost savings over competing products. The company also believe that its combination of branded and authorized generic lines offers physicians, women, and payors cost-effective alternatives for top-quality care. The company supply its prescription products to consumers through retail pharmacies nationwide. The company's fully staffed customer care center uses current customer relationship management software to respond to health care providers, pharmacies, and consumers via incoming and outgoing telephone calls, e-mails, and live-chat. As of January 1, 2017, the company stopped selling its products through its websites directly to consumers.
As health care becomes increasingly consumer driven, patients are seeking more information, control, and convenience, which places additional time and financial pressures on physicians, and as a result, physicians are looking for improved ways to provide better service to their patients. A recent study by IMS Health Inc. concluded that physicians desire fewer but more encompassing relationships with companies that can provide more valuable information, deliver more relevant services, and better respond to specific needs of their practice and patients. The company's goal is to meet this challenge by focusing on the opportunities in women’s health, specifically the OB/GYN market, to provide a better customer experience for physician, payor, pharmacist, and patient through the following means:
- The company believe the company will offer physicians a comprehensive product line of women’s health care products, including its hormone therapy drug candidates, if approved.
- The company's hormone therapy drug candidates are designed to use the lowest effective dose for the shortest duration.
- The company believe the attributes of its dietary supplements will result in greater consumer acceptance and satisfaction than competitive products while offering the highest quality products incorporating patented ingredients, such as Quatrefolic®, FOLMAX®, FePlus®, and pur-DHA™. All of its prenatal vitamins are gluten-, sugar-, and lactose-free.
- The company strive to improve its existing products and develop new products to generate additional revenue through its existing sales channels.
- The company believe health care providers are able to offer alternatives to patients that meet the patient’s individual nutritional and financial requirements and help patients realize cost savings over competing products.
- mproved patient education, a high level of patient compliance, and reduced cost of products all result in lower cost of care for payors and improved outcomes for patients.
Growth Strategy
TherapeuticsMD is a women’s health care company with a corporate culture designed to foster innovation in the development and commercialization of products that address the needs of patients, pharmacists, payers and providers in the twenty-first century.
The company believe that building a culture of innovation around patient needs and opportunities, rather than focusing on specific drugs, will enable it to effectively develop and commercialize its products.
Exclusive Focus on Women’s Health Issues. TherapeuticsMD has steadily developed relationships with many of the largest OB/GYN practices in the country through the sales of its line of prenatal vitamins. The company believe that its singular focus on women’s health issues will enable it to continue to build long-term relationships with women as they move through their life cycles of family planning through menopause.
Focus on Hormone Therapy Products. The company plan to continue its focus on the development, clinical trials, and commercialization of hormone therapy products designed to (1) alleviate the symptoms of, and reduce the health effects resulting from, menopause-related hormone deficiencies, including hot flashes and vaginal dryness, and (2) demonstrate equivalent clinical efficacy at lower doses, enabling an enhanced side effect profile compared with competing products. The company believe there is a large unmet need in this segment of the market.
Penetrate Compounding Market with FDA-approved Products. As TherapeuticsMD is not aware of any current FDA-approved hormone therapy combination products that are bioidentical to – or having the same chemical and molecular structure as - the estradiol and progesterone produced by the ovaries, the company believe that its hormone therapy drug candidate for combined estradiol and progesterone, if approved by the FDA, will provide a safer and more effective alternative to non-FDA approved compounded bioidentical hormone therapy products, at a lower price to patients since most insurance companies do not provide coverage for non-FDA approved compounded products. The company intend to work with independent and community based pharmacies that currently compound bioidentical hormone therapy products to help them transition their patients to its hormone therapy products, if approved. The company launched the BIO-IGNITE™ program, an outreach program to quantify the number of compounded bio-identical estradiol and progesterone prescriptions currently dispensed by the 3,000-3,500 high-volume compounding pharmacies and qualify their interests in dispensing its hormone therapy product candidates, if approved. As part of the BIO-IGNITE™ program, the company intend to work with compounding pharmacies to identify the number of compounded estradiol and progesterone prescriptions that are directly substitutable by the two potential doses of TX-001HR, if approved, and to enter into agreements with such pharmacies to dispense its hormone therapy products in lieu of compounding, if approved.
Multi-Channel Marketing Emphasis. The company plan to continue its emphasis on large group OB/GYN practices that provide opportunities to reach large patient bases and that are receptive to the data and savings the company provide. The company believe this will effectively position it for the launch of its hormone therapy products, if approved.
In addition, proliferation of digital technology has dramatically increased the amount of information to available to patients and providers putting more power in their hands. The company believe this makes patient/provider engagement and experience a more important lever for life sciences companies and that providing patients and providers with important information whenever and however they want it, on a real-time basis, is a critical piece of serving this market.
Multiple Sales Partners. The company plan to continue to pursue multiple sales partners, including large chain pharmacies, independent community pharmacies, mail order and compounding and specialty pharmacies. The company believe providing a higher level of customer care through unique programs targeted at each of these sales partners can produce better outcomes and value for the patient, provider and payer.
Geographical Expansion. The company currently plan to expand its geographic market and sales team to approximately 150 professionals as the company commercialize its TX-001HR and TX-004HR product candidates, if approved.
