Gonorrhea – Heiki http://heiki.org/ Thu, 02 Dec 2021 15:20:23 +0000 en-US hourly 1 https://wordpress.org/?v=5.8 https://heiki.org/wp-content/uploads/2021/04/cropped-icon-32x32.png Gonorrhea – Heiki http://heiki.org/ 32 32 Here’s why a sexual health clinic ended up in a Las Vegas church https://heiki.org/heres-why-a-sexual-health-clinic-ended-up-in-a-las-vegas-church/ Thu, 02 Dec 2021 02:02:00 +0000 https://heiki.org/heres-why-a-sexual-health-clinic-ended-up-in-a-las-vegas-church/

With the increase in sexually transmitted diseases, public health officials in southern Nevada are trying something new: to open a sexual health clinic in a church.

On Wednesday, World AIDS Day, senior officials from the Southern Nevada Health District gathered to mark the grand opening of the All Saints Episcopal Church Clinic in downtown Las Vegas.

The clinic, in a room overlooking a peaceful courtyard with benches and statues of saints, will provide HIV testing and other services related to the prevention, detection and treatment of sexually transmitted diseases.

“We are making HIV testing more accessible to people in our community in a location that offers a safe space and environment,” said Dr Fermin Leguen, district health manager for the County Public Health Agency. Clark, on the district-church partnership.

There is no existing model for a sexual health clinic in a church, health district officials said. However, the church served as a popular site for COVID-19 testing and vaccinations, making this new venture a natural extension. Customers seen during the clinic’s smooth opening gave positive feedback about the environment, said Lourdes Yapjoco, nurse in charge of community health.

Reverend Rafael Pereira, priest in charge of All Saints’ Day, considers the twinning of the church and the clinic to be natural.

“Our principles and core values ​​say we don’t judge, we don’t exclude, we don’t close doors,” Pereira said of his 500-member church on Washington Avenue near Decatur Boulevard.

“We are opening the doors. “

STD on the rise

In Clark County, more than 10,600 people are living with HIV and 325 were newly diagnosed in 2020, Leguen said.

“As we continue to make progress against HIV and AIDS, there are still too many people in the community who don’t know their HIV status,” Leguen said. “It means they don’t have access to the proper care that can keep them healthy.”

Clinic services will include testing for HIV and other sexually transmitted diseases, pre-exposure prophylaxis (PrEP) to prevent HIV infection, telehealth visits with a district health provider, education in sexual health issues and the provision of condoms.

Early diagnosis is essential for people living with HIV so that they can benefit from antiretroviral therapy (ART). ART reduces levels of HIV in the blood and HIV-related illnesses, and reduces the risk of transmitting HIV to intimate partners. With ART, people with HIV can stay healthy for many years, depending on the district.

Although HIV and AIDS were the center of formal remarks on Wednesday, they are not the only concern.

New cases of HIV and AIDS in Clark County declined 4% between 2011 and 2020, according to statistics from the Nevada Department of Health and Human Services.

During the same period, however, cases of chlamydia increased by 60 percent and those of gonorrhea by 214 percent, according to a snapshot provided by the health district. Syphilis cases increased by 259%, with newborn cases increasing by 1,333 percent.

Pereira wants his church to be part of the solution to a community problem.

“As a church, we bring people together, we connect with them,” he said. “We know their needs. and we have to adapt to this changing world.

Contact Mary Hynes at mhynes@reviewjournal.com or 702-383-0336. To follow @ MaryHynes1 on Twitter.



Source link

]]>
HIV after exposure? Transmission, risk factors and more https://heiki.org/hiv-after-exposure-transmission-risk-factors-and-more/ Tue, 30 Nov 2021 21:44:07 +0000 https://heiki.org/hiv-after-exposure-transmission-risk-factors-and-more/

HIV is a virus that weakens your immune system by killing CD4 cells, which are a type of immune cell. People living with untreated HIV are more vulnerable to the disease.

HIV can develop into AIDS if left untreated. The World Health Organization estimated at the end of 2020 that about 37.7 million people are living with HIV around the world.

HIV is transmitted between people through bodily fluids. Unprotected anal or vaginal sex and sharing needles are common ways for people to get HIV. People can also pass HIV to their babies during pregnancy or while breastfeeding.

HIV can be transmitted even with a single brief exposure. The authors of a 2014 review of studies estimated the risks of infection for various types of exposure. Based on their data, the table below shows the estimated risk of contracting HIV for a single exposure event:

There are a number of factors that can influence your chances of getting HIV after exposure. Read on as we take a look at these factors and what to do if you think you’ve been exposed.

HIV is transmitted between humans through bodily fluids. Here are the most common modes of transmission.

Sex without a condom or barrier method

HIV can be transmitted by:

  • some blood
  • sperm
  • pre-seminal fluid (pre-ejaculate)
  • rectal fluids
  • vaginal fluids

It is possible to get HIV when any of these fluids from a person living with HIV come in contact with your mucous membranes, such as those found in:

Sharing needles

Needles can pass small amounts of blood from person to person, even if no blood is visible on the syringe. Sharing needles also increases the risk of developing other illnesses such as hepatitis B or C.

HIV and pregnancy

HIV can be passed from parent to child during pregnancy, during childbirth or through breast milk. Parent-to-child transmission is the The most common how children get HIV.

There are ways for a pregnant person living with HIV to avoid passing the virus on to their child. According to CDC, if a pregnant person takes anti-HIV drugs throughout pregnancy and childbirth, and the baby is given anti-HIV drugs for 4-6 weeks after birth, the risk of transmission is less than 1 %.

The following factors influence your chances of developing HIV after exposure.

Viral load

Viral load is a measure of the amount of virus in a person’s blood. The higher a person’s viral load, the higher their chance of passing HIV to another person. People who take HIV medicines may suppress HIV to the point where it is undetectable after 7 to 12 months and therefore not transmissible.

Multiple exhibitions

Multiple exposures to HIV increase the risk of infection. For example, if you have sex without a condom or other barrier method with someone who is HIV positive several times, your risk of contracting HIV increases.

Multiple sexual partners

Having more than one sex partner increases the chances that one of your partners will be infected with HIV.

Have an STI

You are more likely to pass HIV when you have genital ulcers or urethritis.

Having other sexually transmitted infections (STIs) like gonorrhea or syphilis suggests having barrier-free sex with at least one sexual partner. Having sex without a barrier method increases the risk of developing HIV infection.

People who do not know they are HIV positive

It is estimated that about 1 in 7 people living with HIV in the United States do not know they have the virus.

People who don’t know they have HIV are less likely to take precautions to prevent transmission to others. They probably don’t take any medicine to suppress the virus either.

If you are not currently infected with HIV, you can prevent your risk of infection by:

  • discussing HIV and STIs with your partner before engaging in sexual activity
  • use a barrier method whenever you engage in sexual activity
  • avoid sharing needles
  • discuss post-exposure prophylaxis (PEP) with your doctor if you may have been exposed to HIV in the past 72 hours
  • getting tested regularly for other STIs or before engaging in sexual activity with a new partner

If you have HIV you can prevent passing it on to others by:

  • discussing HIV and STIs with your partner before engaging in sexual activity
  • use a barrier method whenever you engage in sexual activity
  • take your medications as prescribed
  • avoiding sharing needles or drug injection equipment
  • get your viral load tested regularly as recommended by your doctor

Pre-exposure prophylaxis (PrEP)

Pre-exposure prophylaxis (PrEP) is a drug that reduces by about 99 percent and injected drugs by about 74 percent when used as prescribed. If you are going to take this medicine you will need to consider how long you need to take it before it becomes effective.

If you think you have been exposed to HIV, here is what you can do.

Speak with a healthcare professional

A healthcare professional can advise you on available tests and let you know if you qualify for PEP.

Trial

It is important to get tested if you think you have been exposed to HIV so that you can start treatment as soon as possible.

HIV tests cannot immediately detect infection. The window period during which a test can correctly identify a positive infection varies depending on the type of test used, but it is at least 10 days after the exhibition.

Post-exposure prophylaxis

Post-exposure prophylaxis (PEP) is a drug treatment that must be taken within 72 hours of exposure, and it can greatly reduce your chances of developing HIV.

The Centers for Disease Control and Prevention (CDC) recommends that anyone between the ages of 13 and 64 have at least one HIV test. It is also essential to get tested after potential exposures.

Types of tests

There are three types of tests used to diagnose HIV:

  • Nucleic acid test (NAT). This test looks for the virus itself in your blood. It is used for people who have symptoms early or have been at high risk.
  • Antibody test. An antibody test is usually done with a blood test, a finger prick, or with oral fluids. The test looks for antibodies made by your immune system to protect you against HIV.
  • Antigen / antibody test. This is usually done with a blood test or a finger prick. It looks for both antibodies and antigens, which are proteins on the surface of the virus.

When to test

HIV tests are not accurate until a certain number of days have passed after exposure. The minimum time who must pass for each type of test is:

  • NAT: 10 to 33 days
  • Antibody test: 23 to 90 days
  • Antigen / antibody test: 18 to 45 days for a blood test or 18 to 90 days for a finger prick

How often to test

If your test is negative, you should retest at the end of your window period.

According to CDC, if your test comes back negative after your window window and you have had no further possible exposure during your window window, then you do not have HIV.

If you think you have been exposed to HIV, it is a good idea to see a healthcare professional as soon as possible. They can walk you through the testing process, let you know if you are eligible for post-exposure prophylaxis, and answer any specific questions you have.

The chances of developing HIV after exposure depend on factors such as the method of exposure, the viral load of the infected person and the number of exposures you have had. It is possible to develop HIV after a single exposure, although this is statistically unlikely.


Source link

]]>
Syphilis cases up 75% in Iowa https://heiki.org/syphilis-cases-up-75-in-iowa/ Mon, 29 Nov 2021 00:15:55 +0000 https://heiki.org/syphilis-cases-up-75-in-iowa/

Cases of syphilis are on the rise in Iowa.

Preliminary data shows a 75% increase in syphilis cases from 2020 to 2021, said George Walton, head of the sexually transmitted disease program at the Iowa Department of Public Health.

Walton said cases of syphilis are increasing amid different demographics than where the disease typically presents itself.

According to the Centers for Disease Control and Prevention, the majority of syphilis cases in the United States involve men who have sex with men. In the state, Walton said there have been more diagnoses of syphilis among women.

“We have seen an increase in more people who are diagnosed with self-report that they use drugs, so that’s probably a factor as well,” Walton said. “But I would say that there isn’t a single population or a single factor contributing by itself to the increase – it seems to be a combination of factors.”

Syphilis can be cured with antibiotic treatment, according to the CDC. However, if the disease is not discovered and diagnosed before it progresses, it can affect the heart, blood vessels, brain, and nervous system.

Although data for 2021 is not yet available, there were 140 more cases of syphilis in Iowa in 2020 than in 2019, according to state surveillance data.

In 2020, more than 80% of syphilis cases in the state were in men.

Walton said national data for STD rates in 2020 and 2021 has yet to be released, but anecdotally, cases appear to be increasing nationwide.

“My colleagues and I across the country are speaking, and everyone I have spoken with in other states is seeing an increase, especially in syphilis,” he said. “It’s very visible, but the rate of increase here in Iowa seems to stand out a bit more.”

Cases of congenital syphilis, when the disease is passed from a pregnant person to their fetus, have also increased dramatically this year, Walton said.

RELATED: STD tracing in Iowa disrupted as COVID-19 cases rise

“The increases we’ve seen this year in Iowa for that have been historic, to be honest about it,” Walton said. “We’ll end the year with at least 10 that fit the case definition, which may not sound like a lot, but just to put that in perspective, last year we had one, and in 2013 we had one.” three, and that was a large, high number. So having 10 in a single year is important.

Cases of congenital syphilis have also increased nationwide, according to the CDC. In 2020, more than 2,000 cases were reported, the highest level since 1994.

Kathryn Edel, a health educator for Johnson County public health, said syphilis cases had also increased in the county.

Johnson County Public Health offers a rapid syphilis test, which is now available to anyone who wants to get tested, Edel said.

“Previously, we could only offer a rapid test for syphilis to selected people, so people who had symptoms or had potential exposure,” she said. “Now we are able to open this eligibility requirement and offer the syphilis test to everyone, and that’s because of what our state is experiencing in terms of syphilis rates.”

Johnson County Public Health is making walk-in appointments for STD testing, Edel said, adding that the testing program is free and does not require ID or insurance.

“So now would be a great time to get tested for syphilis,” she said.

Rates of chlamydia and gonorrhea, other sexually transmitted diseases, have also increased in the state, with gonorrhea rates having doubled in the past five years, along with chlamydia, Walton said.

“We usually see an increase in the number of chlamydia every year,” he said. “This is the one that is very often asymptomatic, so we often say that the more successful you test, the more individuals you will diagnose.”

Walton said the Department of Public Health was encouraging more routine testing for the disease.

The CDC’s current guidelines for syphilis screening state that anyone with symptoms of syphilis or a partner who has recently been diagnosed with the disease should be tested, in addition to routine testing for pregnant women and men with sex with men.

“As we’ve seen increases in Iowa and we’ve seen increases in other parts of the United States, we’re trying to promote and encourage more testing because… there are additional populations that don’t. weren’t as affected in the past as they are affected now, “Walton said.” Basically we’re trying to promote that it’s more of a routine test for sexually active people. “


Source link

]]>
changing the conversation around sexual health https://heiki.org/changing-the-conversation-around-sexual-health/ Sat, 27 Nov 2021 08:01:00 +0000 https://heiki.org/changing-the-conversation-around-sexual-health/ If there’s one thing we’ve learned about during the pandemic – other than Netflix and baking – it’s health testing. Scratching our tonsils, sticking things in our nostrils, popping bodily fluids in mailboxes, downloading QR codes, scanning us all the time. It has become second nature. (Just like having analyzed various pieces of us, from our gut microbiome to our DNA structure, for the sake of health sustainability, ancestral curiosity, etc.).

Particularly since Covid, discussing and sharing our state of health with others has become second nature – so why not apply this new awareness to our sexual health?

Let’s talk about STIs, baby. No seriously. Whether you are a serial monogamist, a sex adventurer, or engaged in recreational sex with others, questions about your sexual health will inevitably arise. STIs – chlamydia, HIV, syphilis, gonorrhea, hepatitis B and C – have always existed; pox, clap, VD were the shameful names they used to be.

Transmitting or catching an STI can happen to anyone, and in the 21st century, everything is fully treatable. But the thing is – how do you go about it? How do you ask a new sexual partner about their state of sexual health without turning an erotic situation into something clumsily clinical?

Bianca Dunne, a 36-year-old sonographer from Dublin, and her friend Georgia Di Mattos, a 36-year-old architect from Brazil, have found a solution – a sexual health app that allows you to discreetly share your sexual health. status with others through your phone.

The two met when their children were babies, in an upscale area of ​​southwest London – think AbFab meets Motherland – and a friendship developed.

During a conversation, Di Mattos told Dunne how she and her husband, a hedge fund manager, were regulars at high-end sex parties like Killing Kittens – and how that often led to the question of sexual health. . And inevitable clumsiness.

Unlike the porn industry, you usually don’t have to prove your sexual health at sex parties. It is not a prerequisite. So how do you ask someone you’re about to have sex with about their sexual health? How do you approach it?

“Test conversation is a passion killer,” says Bianca Dunne. “And when you’re young, it can be a particularly difficult conversation to have. Two years ago, that led Di Mattos to share a business idea with Dunne.

A home sexual health kit that tests for the STIs listed above, via blood and urine samples taken not at a clinic, but in your own bathroom. Six tests for £ 99, delivered to your door. Once your samples are sent for lab analysis, the results will appear on your phone a few days later. #

Which means you are able to share your health status with other interested parties making sure everyone has a good sexual health record. They called it the iPlaySafe app.

“It helps normalize the behavior of the tests,” Bianca Dunne tells me. “STIs are coming. It is a fact of life. It’s how you treat them that matters – responsibly and without shame. We test proactively rather than reactively. In other words, you take control of the situation, rather than taking a risk or waiting for symptoms to develop to investigate further. Yet even if you take control and are fully open and grown up about your sexual health, it can still be tricky; I remember taking a partner to a walk-in sexual health clinic a few years ago and meeting a friend there with her partner. As she and I chatted, the two men seemed close to death in discomfort. An app would have been so much better.

“My mother-in-law is a former sexual health nurse who is almost 70 years old, and she totally agrees,” Dunne told me, adding, “I have two boys and I don’t want that. they suffer from embarrassment about their sexual health. “But as Di Mattos and Dunne developed their idea and raised funds for it, the pandemic struck, and all the labs they wanted to partner with were suddenly inundated with Covid scans. Now, however, things are moving.

“We’ve spent two years putting it all on the line, and now it’s all about making it work properly,” says Dunne. “We’ve had several thousand downloads of the app – the entry point is buying out of the box. We are in talks with the NHS, and Ireland is our next stop. In Ireland there was a spike in syphilis – and the problem with Ireland is that because it’s a small country, ordering a home test kit means people don’t have to go. go to the clinics where their neighbor is at the reception. She continues: “Overall the app has been a pretty Irish affair. It was developed by Zendra Health, a medical technology company run by twin brothers from Cork. It’s not just for people who go to sex parties. Dunne would like to stress this – that it is for anyone who has sex.

“Georgia’s lifestyle isn’t the same as everyone’s – so we want our app to have the universal appeal of, say, Love Island,” she says. “This is for two people who are having sex with each other. However, their brand ambassador is not an adorable Love Island, but a promising MMA fighter, Ian Garry, whom Dunne calls “the next Conor McGregor” – Garry’s fighter name is The Future.

“Georgia and I are boxing in a club in Richmond [in south west London], where we learned that before every MMA match, fighters had to be tested for hepatitis B and C and HIV, ”says Dunne. “We wanted to hire more men – so we took a punt on Ian Garry and sponsored him.” Such inclusion and a positive sex attitude made the two women wonder why they didn’t just run a dating app – but that’s not where their interest lies. Or more specifically, why don’t dating apps, especially those associated with casual and casual sex, integrate sexual health checks into their software?

“Dating apps are run by conservative American men who don’t want to be associated with sex,” says Dunne. “We would like our test app to be standardized – we have no interest in running a dating app ourselves, just the testing aspect.” What’s amazing is that dating apps don’t rush to tie the test app to their own platforms; their disgust seems counterintuitive. As if they were missing something.

Forbes estimates that by 2023 the global sexual well-being industry will be worth $ 37.2 billion, well beyond leading novelty outlets like Goop, with their jade eggs and scented candles. to the vagina.

OPEN THE WAY

Sextech is expanding beyond apps and gadgets – many of its innovators and entrepreneurs are women, keen to research women’s sexual health, which as we all know has been a long neglected area. . Bianca Dunne and Georgia Di Mattos are in good company.

Lioness sex research platform

Launched during lockdown by Liz Klinger and Anna Lee – inventors of the first smart vibrator to collect biofeedback on female arousal and orgasm, collating anonymized data from over 50,000 female orgasms – the female-led sextech platform continues its pioneering mission to advance research on female sexuality from the 1980s to the 21st century.

Make love not porn

Launched by Cindy Gallop in 2009 and converted in 2013 to the first ‘human-made and user-created social sex video sharing platform to promote consent, communication, good sexual values ​​and good sexual behavior The goal of MLNP is to combat rape culture and the traditional porn industry by showing real sexual behavior. So your kids don’t grow up thinking that the porn on their phone is the way sex is in real life.

Quinn Audio porn for people of all genders and sexualities, developed by Caroline Spiegel, sister of Snap CEO Evan Spiegel.

Originally describing her app at a TED talk as “a much less disgusting and more fun porn hub for women,” she soon realized that it wasn’t just women using it. Men were too, despite expectations regarding male preferences for all-visual pornography – Quinn is a non-visual medium.


Source link

]]>
Agriculture, Paul Harvey, Have a nice day – https://heiki.org/agriculture-paul-harvey-have-a-nice-day/ Wed, 24 Nov 2021 22:03:17 +0000 https://heiki.org/agriculture-paul-harvey-have-a-nice-day/

My agricultural career ended last week. My wife and I have sold our eleven acres in Clinton County, and we are no longer part of the “we feed the world” crowd. Our contribution will go down in history in the form of eleven acres of beans grown and delivered somewhere. No cards, please.


I wouldn’t mind if you played this Paul Harvey “God Made A Farmer” at my funeral, though. It would make me sound cooler than my actual existence of typing on a keyboard most of my life. I’m not much of a farmer, but I drive a truck and ride for combines on the highway.


I had a teacher in high school who passed the news on Paul Harvey to us every morning. He took the time to record it in the morning on a tape, then play it for the class. Would it even be allowed now? Wouldn’t anyone be complaining about the network news they exposed your kids to? I am not sure that we are progressing as a society. Be your own judge, but I certainly miss Paul Harvey and thankful that my teacher mastered the art of playing on the tape player when the program was on the news; it is a more difficult task than you might think.


By the way, Paul Harvey was worth $ 150 million when he threw the bucket in 2009. It’s a bucket of radio commercials.


Speaking of announcements. I’m totally intrigued by an ad that continues to run during Chiefs games. This is an ad from the Kansas Department of Health asking people to get vaccinated. The lady in the ad says her husband contracted COVID and died after the family attended a chiefs party.

It’s incredibly sad, but I think it’s a pretty incredulous leap that the people in government are taking in pointing out how and when people contracted COVID. I’m not sure anyone can pinpoint when they catch a particular virus, but here’s a state sponsored ad taking that leap. They are not scientists, but I guess you already know that.


I would like to correct this last stanza. Some viruses / diseases are easy to identify when they are contracted. Mainly syphilis, gonorrhea and the like, but I guess some of you already know that too.

I just used google to spell check syphilis and gonorrhea and now my Facebook and TikTok accounts will be filled with STD advice. I would like to remind you again that I am not sure that we are progressing as a society. You decide.


Paul Harvey had 24 million listeners. It’s a little more reach than this column, but we are growing! It’s a question of time. I guess I had about 25 readers after writing this column for a few decades for a few different articles. Assuming you live, and I live, we could be at 100 by the end of this decade. To your good health!


Happy Thanksgiving and everyone. Don’t talk politics at the dinner table. Keep it simple by drinking stories of episodes from your youth and gut health and other healthy conversations; can’t go wrong there. Stay out of wine, it never helps.

Good day.

(Guy Speckman can be reached at gspeckman@me.com or by listening to the rest of the story on tape)


Source link

]]>
Report: What Happened to Communicable Diseases in 2019? – State of the reform https://heiki.org/report-what-happened-to-communicable-diseases-in-2019-state-of-the-reform/ Tue, 23 Nov 2021 22:59:55 +0000 https://heiki.org/report-what-happened-to-communicable-diseases-in-2019-state-of-the-reform/

Even as COVID-19 continues to grab the headlines, other diseases continue to spread in Washington, and a recent report from the state Department of Health provides information on the status of several communicable diseases in 2019.

The report, released in September, summarizes the communicable diseases reported by local health authorities. The most frequently reported diseases remain sexually transmitted diseases, chronic hepatitis, diarrheal infections, whooping cough and tuberculosis. However, only a fraction of the actual number of cases are reported to a surveillance system, and many people may not know they have an active infection or have not sought care.

Get the latest information on state-specific policies for the healthcare industry delivered to your inbox.

The rate of Chlamydia trachomatis was higher in 2019 than any previous year since at least 1989, when the data in the report stops. In 2019, there were 498.8 infections per 100,000 people statewide. Whitman, Yakima and Franklin counties had the highest infection rates per 100,000, while King County had the highest number, with 11,547 infections.

Gonorrhea was also at its highest rate since 1987, with 157 infections per 100,000. Yakima, Pierce and King counties had the highest rates of gonorrhea infections per 100,000 population.

Chronic hepatitis B cases were much higher in 2019, both in rate and number. The statewide rate of chronic hepatitis B was 89.5 per 100,000 that year, up from 29.2 per 100,000 in 2018. Mason, Grays Harbor and Pacific counties recorded the highest rates. At the same time, the rate of chronic hepatitis C declined in 2019, from 108.9 in 2018 to 89.2 per 100,000 in 2019.

The rate of HIV cases per 100,000 was slightly higher in 2019 than the previous year, continuing an upward trend in the state since 2011. In 2019, there were 181.7 HIV cases per 100,000 Washingtonians. , the highest rates being observed in Mason and King. counties. In 2019, 141 deaths were attributed to HIV statewide.

The number of syphilis cases, including primary and secondary infections, also increased in 2019, reaching 11 cases per 100,000 and a total of 830 cases statewide. Spokane, Cowlitz and King counties experienced the highest rates.

It’s also worth noting that the number of Lyme disease cases also increased in 2019, to 43, from 20 in 2018. There have also been 90 cases of measles reported statewide, largely due to of two epidemics that occurred that year.


Source link

]]>
Evofem Biosciences successfully extends the cumulative net sales commitment date until June 30, 2023 https://heiki.org/evofem-biosciences-successfully-extends-the-cumulative-net-sales-commitment-date-until-june-30-2023/ Mon, 22 Nov 2021 11:50:00 +0000 https://heiki.org/evofem-biosciences-successfully-extends-the-cumulative-net-sales-commitment-date-until-june-30-2023/

SAN DIEGO, 22 November 2021 / PRNewswire / – Evofem Biosciences, Inc., (NASDAQ: EVFM) today announced that it has successfully extended its cumulative net sales commitment schedule for its april 2020 Contract for the purchase of securities and June 30, 2023.

Evofem Biosciences (Nasdaq: EVFM) (PRNewsfoto / Evofem Biosciences, Inc.)

“We appreciate that these healthcare investors see the potential for long-term growth. June 30, 2023,” noted Saundra Pelletier, CEO of Evofem Biosciences.

  • Over 19,000 prescriptions for Phexxi® (lactic acid, citric acid and potassium bitartrate) were filled in the third quarter of 2021, an increase of 48% from the previous quarter.

  • With more than 10,000 Phexxi prescriptions in October 2021, up 30% from September 2021, Evofem is on track for another solid quarter of Phexxi prescription growth.

  • Phexxi’s ex-factory sales (shipments to wholesalers, on which gross revenue is based) increased 19% in October compared to September 2021.

“With the strong demand for Phexxi and the upcoming adjustments to our patient support program which will result in improvements in our gross / net and net revenues from December 2021, this is a achievable time frame,” Pelletier concluded.

About Evofem Biosciences
Evofem Biosciences, Inc. (NASDAQ: EVFM) develops and markets innovative products to address unmet sexual and reproductive health needs of women, including female-controlled hormone-free contraception and protection against certain sexually transmitted infections ( chlamydia and gonorrhea). The company’s first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0 to 60 minutes before each intercourse. Learn more at phexxi.com and evofem.com.

Phexxi® is a registered trademark of Evofem Biosciences, Inc.

Forward-looking statements
This press release includes “forward-looking statements” within the meaning of the safe harbor for forward-looking statements under Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, including , without limitation, statements and judgments on the long-term value of Phexxi and demand for Phexxi, Evofem’s gross-to-net improvement efforts, Evofem’s ability to meet the cumulative net sales threshold on or before June 30, 2023, and the extension of the cumulative net sales covenant, which is conditional on the completion of financing by Evofem. Various factors could cause actual results to differ materially from those discussed or implied in the forward-looking statements, and you are urged not to place undue reliance on such forward-looking statements, which are only current as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors which could cause actual results to differ materially from those discussed or involved in forward-looking statements, or which could adversely affect the value of Evofem Biosciences assets and businesses, are disclosed in the documents filed by the company. with the SEC, including its annual report on form. 10-K for the year ended December 31, 2020 filed with the SEC on March 4, 2021. All forward-looking statements are expressly qualified in their entirety by such factors. For more complete information regarding the modification of the april 2020 Securities and Security Purchase Agreement, please refer to the company’s current report on Form 8-K filed with the SEC on 22 November 2021. The Company does not undertake any obligation to update forward-looking statements, except as required by law.

Investor Relations Contact
Amy raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775

Cision

Cision

View original content to download multimedia: https://www.prnewswire.com/news-releases/evofem-biosciences-successfully-extends-cumulative-net-sales-covenant-timing-to-june-30-2023-301429625 .html

SOURCE Evofem Biosciences, Inc.


Source link

]]>
Gonorrhea infection in girls comes from a hot spring: a case study https://heiki.org/gonorrhea-infection-in-girls-comes-from-a-hot-spring-a-case-study/ Thu, 18 Nov 2021 20:36:15 +0000 https://heiki.org/gonorrhea-infection-in-girls-comes-from-a-hot-spring-a-case-study/

TORONTO – An 11-year-old Austrian girl who contracted gonorrhea after bathing in a hot spring reminds authorities investigating similar cases that these types of infections are not always an automatic indicator of sexual abuse, suggests a new case study.

The report, published in September in the Journal of Medical Case Reports, details the case of an 11-year-old girl diagnosed with gonorrhea two weeks after a family vacation in Italy in August 2020.

The family had spent some of it in hot springs next to a crater lake known as Specchio di Venere, or “Mirror of Venus,” on the island of Pantelleria off the coast of southern Greece. Italy.

Two days after the hot spring visit, the girl began to develop itching and burning, which was alleviated with an antifungal cream, but after the trip she saw a pediatrician who was able to diagnose her with gonorrhea after a few tests.

“The child categorically denied any sexual contact,” the authors wrote in the case study. “The family was traveling together on vacation when the symptoms started, and there was no evidence or identified opportunity for sexual transmission. It was therefore concluded that she must have acquired the infection from swimming pool water contaminated with gonococcus.

The child was treated for the infection and eventually made a full recovery.

The authors indicate that this case study is an example of why authorities should not automatically assume sexual abuse in such cases.

“A presumption that gonococcal infection is a diagnosis of sexual abuse can be disastrous, with children wrongly removed from the care of their parents and their caregivers facing false charges of sex crimes,” the study said. “Our case serves to illustrate that the very rare diagnosis of gonorrhea in a child may be the result of non-sexual transmission of the infection, and that contaminated hot swimming pools are a very rare source of infection that should be taken into account. account.”

The study says there have been cases in Canada, Australia, New Zealand, the United States and Denmark where experts told the court that genital gonorrhea in a child could not have occurred. produced only by any form of sexual activity, when it was later found that the infection had actually spread through non-sexual means.

Children’s hospitals have in the past linked outbreaks of gonorrhea to common baths, towels, washcloths, and diapers, to name a few. Other cases have linked transmission to contaminated toilet seats and shared beds.

As for the hot springs, the researchers note that the hot, acidic water, in addition to the mineral content found in these pools, could potentially increase the survival of the bacteria.

“This rare event is likely due to a number of unique factors, including the timing of the infant’s bath versus that of an infected visitor, but those using these pools should be alerted to the possibility of such. exposure, including the risk of possible conjunctival infection, on occasion, ”the researchers note.


Source link

]]>
Eleven-year-old girl who bathed in hot spring diagnosed with gonorrhea: a case study https://heiki.org/eleven-year-old-girl-who-bathed-in-hot-spring-diagnosed-with-gonorrhea-a-case-study/ Wed, 17 Nov 2021 19:12:42 +0000 https://heiki.org/eleven-year-old-girl-who-bathed-in-hot-spring-diagnosed-with-gonorrhea-a-case-study/

The young girl developed the symptoms after swimming in a lively hot swimming pool by the Specchio di Venere (Mirror of Venus) in Italy.

Content of the article

An 11-year-old Austrian girl was diagnosed with gonorrhea after returning from a family vacation in Italy where she allegedly bathed in a hot spring.

Content of the article

The girl first developed symptoms after swimming in a hot, busy swimming pool by the crater lake Specchio di Venere (“Mirror of Venus”) on the island of Pantelleria, Italy.

According to a case study published on September 17, she developed vulvovaginitis – inflammation and irritation of the vagina or vulva, usually soothed with an antifungal cream.

Vaginal swabs that test positive for Neisseria gonorrhoeae, a sexually transmitted bacterial infection. His family members, however, tested negative.

Researchers learned that family members waded through different pools on the lake, with her father and she entering one pool while her mother and sister entered another.

Although the disease can be transmitted through sexual contact, the girl categorically denied any such contact, researchers from the New Zealand University of Auckland and the Austrian University of Salzburg said in the study.

Content of the article

Instead, experts believe the hot temperature, the acidic nature of the water, and the presence of organic particles could explain why she got infected with the virus. Historical reports of gonococcal outbreaks in children’s hospitals also show that the disease dates back to common baths, according to the study.

Her pediatrician recommended that she take whey baths for two weeks to restore her vaginal flora and calm her symptoms. By week four, her swab came back negative.

Although the story ends well for the girl, “it’s not a diagnosis to be missed,” the researchers wrote in the study, published in the Journal of Medical Case Reports . “A presumption that gonococcal infection is a diagnosis of sexual abuse can be disastrous, with children wrongly removed from the care of their parents and their caregivers facing false charges of sex crimes. “

They suggested adding a sign, a shower and antibacterial soap near the hot springs, to educate visitors about the risks of frequent bathing in the shallow pools.


Source link

]]>
EVOFEM BIOSCIENCES, INC. Discussion and analysis by management of the financial position and results of operations (Form 10-Q) https://heiki.org/evofem-biosciences-inc-discussion-and-analysis-by-management-of-the-financial-position-and-results-of-operations-form-10-q/ Mon, 15 Nov 2021 21:18:18 +0000 https://heiki.org/evofem-biosciences-inc-discussion-and-analysis-by-management-of-the-financial-position-and-results-of-operations-form-10-q/
The terms "we," "us," "our," "Evofem" or the "Company" refer collectively to
Evofem Biosciences, Inc. and its wholly-owned subsidiaries, unless otherwise
stated. All information presented in this quarterly report on Form 10-Q
(Quarterly Report) is based on our fiscal year. Unless otherwise stated,
references to particular years, quarters, months or periods refer to our fiscal
years ending December 31 and the associated quarters, months and periods of
those fiscal years.

You should read the following discussion and analysis of our financial condition
and results of operations together with our condensed consolidated financial
statements and related notes appearing elsewhere in this Quarterly Report. For
                                       26
--------------------------------------------------------------------------------
  Table of Contents
additional context with which to understand our financial condition and results
of operations, see the audited consolidated financial statements and
accompanying notes contained therein as of December 31, 2020 and 2019 and
related notes in the Company's Annual Report on Form 10-K as filed with the SEC
on March 4, 2021 (2020 Audited Financial Statements). This discussion and
analysis contains forward-looking statements that involve risks, uncertainties
and assumptions. The actual results may differ materially from those anticipated
in these forward-looking statements as a result of certain factors, including,
but not limited to, those set forth under Item 1A of Part I of the 2020 Audited
Financial Statements. Unless otherwise defined in this section, the defined
terms in this section have the meanings set forth in the 2020 Audited Financial
Statements.

Overview

We are a San Diego-based commercial-stage biopharmaceutical company committed to
developing and commercializing innovative products to address unmet needs in
women's sexual and reproductive health.

Our first commercial product, Phexxi® (lactic acid, citric acid, and potassium
bitartrate) vaginal gel (Phexxi), was approved by the United States (U.S.) Food
and Drug Administration (FDA) on May 22, 2020 and commercially launched in the
United States in September 2020. Phexxi is the first and only FDA approved
hormone-free, woman-controlled, on-demand prescription contraceptive gel for
women. We are conducting a pivotal Phase 3 clinical trial to evaluate our lead
product candidate, EVO100 (L-lactic acid, citric acid, and potassium bitartrate)
vaginal gel (EVO100), for the prevention of urogenital transmission of both
Chlamydia trachomatis infection (chlamydia) and Neisseria gonorrhoeae infection
(gonorrhea) in women. We refer to this trial as "EVOGUARD".

Phexxi: our non-hormonal contraception on demand


We commercially launched Phexxi in September 2020 with a sales force promoting
Phexxi directly to obstetrician/gynecologists and their affiliated health
professionals, who collectively write the majority of prescriptions for
contraceptive products. Our sales force comprises approximately 69 regional
sales representatives and business managers, supported by a self-guided virtual
health care provider (HCP) learning platform. Additionally, we offer women
direct access to Phexxi via our telehealth platform where women can directly
meet with an HCP to determine their eligibility for a Phexxi prescription and
potentially have it written by the HCP, filled, and mailed directly to them by a
third party pharmacy.

Our comprehensive commercial strategy for Phexxi includes marketing and product
awareness campaigns targeting women in the United States of reproductive
potential, including the approximately 23 million women who are not using
hormonal contraception and the approximately 18.8 million women who are using a
prescription contraceptive, some of whom, particularly pill users, may be ready
to move to an FDA-approved, non-invasive hormone-free contraceptive, as well as
certain identified target HCP segments; payer outreach; and execution of our
consumer digital and media strategy.

According to our post-commercial launch market research, HCPs indicated they
would recommend Phexxi to approximately 60% of patients who are currently using
natural contraceptive methods, approximately 58% of patients who are currently
using over-the-counter contraceptive products and approximately 26% of patients
who are currently using prescription contraception or methods requiring an HCP
to perform a procedure. Additional research into the demographics of more than
1,300 women who are using Phexxi reveals that 60% of Phexxi users are between
the ages of 18 to 34 years of age. Among the subset of Phexxi users for whom
prior contraceptive data is available (n=413), 39% of women who had recently
started Phexxi switched over from either an oral contraceptive, hormone
patch/ring, or long-acting reversible contraception.

In December 2020 two U.S. patents that cover Phexxi and its labeled indication
were listed in the U.S. FDA publication Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly known as the Orange Book. The Orange Book
listing of these two patents covering Phexxi's composition of matter and its
method of use in prevention of pregnancy is an important step in the ongoing
development of our patent portfolio, which currently covers Phexxi into 2033.
The newly listed method of use patent, number 10,568,855 (the '855 patent),
covers contraception using the L-lactic acid Phexxi formulation. The '855 patent
was issued by the U.S. Patent and Trademark Office (USPTO) on February 25, 2020
and is expected to expire in March 2033. The newly listed patent number
6,706,276 (the '276 patent) is a composition of matter patent covering Phexxi.
Evofem has an exclusive license to this patent, which is held by Rush University
Medical Center (Rush University). The '276 patent was issued by the USPTO on
March 16, 2004 and is expected to expire in March 2026 if the five-year patent
term extension (PTE) application that was timely filed by the patent owner is
granted. The patents we licensed from Rush University expired in March 2021
outside the United States and are currently set to expire in March 2022 inside
the United States pursuant to an Order Granting Interim Extension that extended
the expiration of the U.S. patent. In 2020, Rush University submitted a PTE
application for the U.S. patent requesting a five-year PTE to 2026. We have not
yet been granted the PTE, and there is no assurance that it will be granted for
the full five-year term, if at all.

On February 14, 2021, we launched a direct-to-consumer advertising campaign,
known as "Get Phexxi," designed to increase awareness and educate women on the
benefits of Phexxi. The campaign highlights some of the struggles women face
                                       27
--------------------------------------------------------------------------------
  Table of Contents
when choosing among the many available methods of contraception, including the
lack of control with condoms, constant daily use of the pill, and abstinence
required for cycle tracking.

On September 9, 2021, we launched a national brand ambassador campaign featuring
Emmy® Award-winning celebrity Annie Murphy designed to broaden awareness and
drive uptake of Phexxi. We believe early metrics demonstrate that this campaign,
called "House Rules," is effectively reaching our target audience, especially
women who are beyond hormones. Through September 30, 2021, the "House Rules" DTC
campaign has resulted in a 263% increase in visitors to Phexxi.com, and impacted
key metrics including:
•A 71% increase in ex-factory sales of Phexxi (unit shipments to wholesalers) in
September versus August 2021.
•More than 5,100 women have begun using Phexxi since the launch of the "House
Rules" campaign, driving a 56% increase in new patient starts in September
versus August 2021.
•More than 2,800 women booked telehealth visits in the first three weeks of the
campaign, a 4x increase over the three-week period pre-launch.
•More than 8,900 Phexxi units were dispensed in September 2021, a 41% increase
over the prior month, and total monthly prescriptions grew 45% to 7,839.
•34% increase in new healthcare providers prescribing Phexxi in September versus
August 2021. Over 9,400 healthcare providers have written Phexxi since the
product launched in September 2020.

We are also collaborating with the National Community Oncology Dispensing
Association, Inc. (NCODA), an educational platform for community and academic
oncology practices nationwide, to positively impact the quality of life for
female patients living with, fighting and recovering from cancer by raising
awareness about the importance and availability of Phexxi as a birth control
option. Every year in the United States, more than 800,000 new cases of cancer
are reported among women, and many cancer treatment protocols require female
patients of reproductive potential to use birth control while undergoing
treatment. Until the introduction of Phexxi, non-hormonal prescription
contraception options were starkly limited; previously, women were generally
steered toward condoms or the copper IUD, a prescription medical device that is
implanted in the uterus where it releases copper ions and can cause
inflammation.

We are working together with NCODA to develop and share resources and
educational information for the medically-integrated oncology pharmacy team to
help support female cancer patients in deciding which contraceptive option best
meets each woman's unique, individual needs. In May 2021, the NCODA published a
Positive Quality Intervention (PQI) in connection with Phexxi, and in July 2021,
our Chief Executive Officer and Phexxi were featured on NCODA's PQI Podcast.
PQIs are part of the NCODA Quality Standards. These resources are designed to
operationalize and standardize practices to achieve positive outcomes for
patients. Additionally, our Chief Executive Officer delivered the keynote
address at the NCODA 2021 National Spring Forum, and two posters on data sets
presenting relevant aspects of the Phase 3 AMPOWER trial evaluating Phexxi were
presented at the conference.

We continue working to increase the number of lives covered and to gain
preferred formulary position for Phexxi. As of October 2021, 70% of Phexxi
prescriptions are being approved either by payers or through Evofem patient
support programs. We have coverage for approximately 55% of U.S. commercial
lives, including approximately 9 million lives covered at no out-of-pocket cost
and approximately 13.7 million lives covered under our December 2020 contract
award from the U.S. Department of Veterans Affairs. On January 1, 2021, the U.S.
Medicaid population gained access to Phexxi through our participation in the
Medicaid National Drug Rebate Program. Medicaid provides health coverage to
approximately 68 million members, including approximately 16.8 million women
19-49 years of age.

Phexxi is classified in the databases and pricing compendia of Medi-Span and
First Databank, two major drug information databases that payers consult for
pricing and product information, as the first and only "Vaginal pH Modulator."

We continue to work with the FDA's Office of Women's Health to update its Birth
Control Guide to include a new category for vaginal pH modulators, as the
current guide does not have a place for Phexxi due to its unique mechanism of
action. We believe this update would require payers (including pharmacy benefit
managers) to cover the Phexxi at no cost to patients. We are also working with
elected officials in Washington D.C. to encourage updating the guidance
regarding contraception coverage, as the guidance has not kept up with
innovations like Phexxi. To support those initiatives, we have launched a
grassroots coalition that shows the public's support of the need for updating
the chart and guidance.

EVO100: our product candidate for the prevention of STIs


Our lead product candidate, EVO100, is a vaginal gel under evaluation for the
prevention of chlamydia and gonorrhea in women - two of the most pervasive
sexually transmitted infections (STIs) in the United States. Currently, there
are no FDA­approved prescription products for the prevention of either of these
common STIs.

                                       28
--------------------------------------------------------------------------------
  Table of Contents
According to the Centers for Disease Control and Prevention (CDC), any sexually
active person can be infected with chlamydia or gonorrhea. Despite the CDC
recommendation for condom use to prevent STIs, U.S. rates of infection with
chlamydia and gonorrhea climbed in 2019 for the sixth consecutive year. Based on
these reports, an estimated 78 million women 18-65 years of age who are sexually
active in the United States could be at risk to contract these STIs.

Based on the positive and statistically significant top-line results of our
Phase 2B/3 AMPREVENCE trial, we initiated our Phase 3 EVOGUARD clinical trial in
October 2020. This randomized, placebo-controlled pivotal trial is designed to
enroll 1,730 women with a prior chlamydia or gonorrhea infection and who are at
risk for future infection. Participants are enrolled for a 16-week
interventional phase followed by a one-month follow-up period. We expect to
complete enrollment in the first quarter of 2022 and to report top-line EVOGUARD
results in the third quarter of 2022. Assuming positive results from the trial,
we expect to submit a supplemental New Drug Application for EVO100 in the first
quarter of 2023.

The FDA has granted Fast Track designations to EVO100 for the prevention of chlamydia and gonorrhea in women. The FDA has designated EVO100 as a qualified infectious disease product for the prevention of gonorrhea in women, which offers several significant potential benefits, including longer market exclusivity.


Financial Operations Overview

Net Product Sales

Our revenue recognition is based on unit shipments from our third-party
logistics warehouse to our customers, which consist of wholesale distributors,
retail pharmacies, and a mail-order specialty pharmacy. We have recognized net
product sales in the United States since the commercial launch of Phexxi in
September 2020; the quarter ended September 30, 2021 was our fourth full quarter
of product sales.

For the quarter ended September 30, 2021, shipments to wholesale distributors
and pharmacies grew significantly compared to the quarter ended June 30, 2021,
driving an approximate 29% increase in gross revenues. Phexxi outperformed the
newer branded contraceptive market over the summer months and the launch of our
"House Rules" campaign on September 9, 2021 has increased Phexxi awareness,
consideration, and prescriptions. Gross revenues, as discussed in   Note 3-
Revenue  , were adjusted for variable consideration, including our patient
support programs.

We intend to out-license commercialization rights for Phexxi to one or more
pharmaceutical companies or other qualified potential partners for countries or
regions outside of the United States. We are currently in discussion with
potential partners for various geographies. We cannot forecast when or if these
arrangements will be secured, the structure or potential amount of revenues from
these arrangements, whether upfront, milestone-related or related to future
Phexxi sales (assuming approval of Phexxi for commercial sale outside of the
United States) or to what degree these arrangements would affect our development
plans, future revenues and overall capital requirements.

Cost of goods sold


The Company began to capitalize the inventory costs associated with Phexxi in
April 2020 when it was determined that this inventory had a probable future
economic benefit. These inventory costs include all purchased materials, direct
labor and manufacturing overhead. Prior to April 2020, costs incurred for the
manufacture of Phexxi were recorded as research and development expenses.

In addition, we are obligated to pay quarterly royalty payments pursuant to our
license agreement with Rush University, in amounts equal to a single-digit
percentage of the gross amounts we receive on a quarterly basis less certain
deductions incurred in the quarter based on a sliding scale. We are also
obligated to pay a minimum annual royalty amount of $100,000 to the extent these
earned royalties do not equal or exceed $100,000 in a given year. A minimum
annual royalty amount of $100,000 was first required for the annual period
commencing on January 1, 2021. This royalty was approximately $0.1 million and
$0.2 million for the three and nine months ended September 30, 2021,
respectively, and was included in the costs of goods sold in the condensed
consolidated financial statements.

                                       29
--------------------------------------------------------------------------------
  Table of Contents
Operating Expenses

Research and development costs


Our research and development expenses primarily consist of costs associated with
the clinical development of EVO100 and costs associated with the continuous
improvements related to Phexxi commercialization efforts. These expenses
include:
•external development expenses incurred under arrangements with third parties,
such as fees paid to clinical research organizations (CROs) relating to our
clinical trials, costs of acquiring and evaluating clinical trial data such as
investigator grants, patient screening fees, laboratory work and statistical
compilation and analysis, and fees paid to consultants;
•costs to acquire, develop and manufacture clinical trial materials, including
fees paid to contract manufacturers;
•costs related to compliance with drug development regulatory requirements;
•continuous improvements of manufacturing and analytical efficiency;
•on-going product characterization and process optimization;
•back-up contract manufacturing organization's evaluation to support future
commercial forecast and reduce cost of goods sold;
•alternative raw material evaluation to secure an uninterrupted supply chain and
reduce cost of goods sold;
•employee-related expenses, including salaries, benefits, travel and noncash
stock-based compensation expense; and
•facilities, depreciation and other allocated expenses, which include direct and
allocated expenses for rent and maintenance of facilities, depreciation of
leasehold improvements and equipment, and research and other supplies.

We charge internal and third party research and development costs as they are incurred. The following table summarizes the research and development expenses by candidate product (in thousands):

                                                        Three Months Ended September 30,               Nine Months Ended September 30,
                                                            2021                   2020                   2021                   2020

Third-party development costs allocated: EVO100 for the prevention of chlamydia / gonorrhea – Phase 3 (EVOGUARD)

                                        $           6,890       

$ 1,386 $ 17,078 $ 1,529
EVO100 for the prevention of chlamydia / gonorrhea – Phase 2B / 3 (AMPREVENCE)

                                                   -                  17                         -                 (10)
Phexxi for the prevention of pregnancy (AMPOWER)                    -                   2                         -                 (14)
Total allocated third-party development expenses                6,890               1,405                    17,078               1,505
Unallocated internal research and development
expenses:
Noncash stock-based compensation expenses                         160                 291                     1,122               1,689
Payroll and related expenses                                    1,048               1,438                     3,988               3,539
Outside services costs                                            275                 705                     1,291               3,343
Other                                                             328                 378                       991               1,028

Total unallocated internal research and development expenditure

                                                        1,811               2,812                     7,392               9,599
Total research and development expenses             $           8,701       

$ 4,217 $ 24,470 $ 11,104




Completion dates and costs for our clinical development programs may vary
significantly for EVO100 and any future product candidate we may seek to develop
and are difficult to predict. We anticipate that we will determine which
programs and product candidates to pursue as well as the most appropriate
funding allocations for each program and product candidate on an ongoing basis
in response to the results of ongoing and future clinical trials, regulatory
developments, and our ongoing assessments of the commercial potential of each
current or future product candidate. We expect research and development expenses
to increase significantly in 2021 compared to 2020 primarily due to EVOGUARD,
which was initiated in October 2020. We will need to raise significant
additional capital in the future to complete clinical development for EVO100 and
any future product candidates.

The costs of clinical trials can vary widely over the life of a program due to the following:


•per patient trial costs;
•the number of sites included in the trials;
•the length of time and level of marketing required to enroll eligible patients;
•the number of patients participating in the trials;
                                       30
--------------------------------------------------------------------------------
  Table of Contents
•the number of doses patients receive;
•potential additional safety monitoring or other trials requested by regulatory
agencies;
•the phase of development of the product candidate; and
•the efficacy and safety profile of the product candidate.

Sales and marketing costs


Our selling and marketing expenses consist primarily of Phexxi commercialization
costs, including direct-to-consumer (DTC) and HCP advertising, the Phexxi
telehealth platform, our sample program, training, salaries, benefits, travel,
noncash stock-based compensation expense, and other related costs for our
employees and consultants.

We expect our selling and marketing expenses to be significantly higher in 2021
compared to 2020 due to the cost of our sales force, which was established in
the third quarter of 2020, and as we continue Phexxi promotional strategies,
including all DTC marketing initiatives.

General and administrative expenses


Our general and administrative expenses consist primarily of salaries, benefits,
travel, business development expense, investor and public relations expenses,
noncash stock-based compensation, and other related costs for our employees and
consultants performing executive, administrative, finance, legal and human
resource functions. Other general and administrative expenses include
facility-related costs not otherwise included in research and development or
selling and marketing, and professional fees for accounting, auditing, tax and
legal fees, and other costs associated with obtaining and maintaining our patent
portfolio.

We expect our general and administrative expenses to decrease slightly in 2021 compared to 2020 due to lower recruitment costs, financial advisory costs, and salary and related costs.

Other income (expenses)


Other income (expense) consists primarily of interest expense and the change in
fair value of financial instruments issued in various capital raise
transactions. The change in fair value of financial instruments was recognized
as a result of mark-to-market adjustments for those financial instruments.

Results of operations


Three Months Ended September 30, 2021 Compared to Three Months Ended September
30, 2020 (in thousands):

Net Product Sales

                                             Three Months Ended September 30,                   2021 vs. 2020
                                                 2021                 2020               $ Change         % Change
Product sales, net                          $      1,712          $      278          $      1,434               516  %


Phexxi was launched commercially in September 2020. The increase in net product sales is mainly due to a full quarter of sales in the current period versus a month of sales in the previous year period, as well as continued growth in unit sales ex works since commercial launch.

Cost of Goods Sold

                                              Three Months Ended September 30,                     2021 vs. 2020
                                                  2021                   2020               $ Change         % Change
Cost of goods sold                        $             955          $      317          $        638               201  %


The increase in cost of goods sold is mainly due to a full quarter of sales during the current period compared to a month of sales during the previous year period.

                                       31
--------------------------------------------------------------------------------
  Table of Contents
Research and development expenses
                                                    Three Months Ended September 30,                     2021 vs. 2020
                                                        2021                   2020               $ Change         % Change
Research and development                        $           8,701          $    4,217          $      4,484               106  %



The increase in research and development expenses was primarily due to a $5.5
million increase in clinical trial costs associated with EVOGUARD. This increase
was partially offset by a $0.4 million decrease in payroll and related expenses
due to lower headcount, a $0.4 million decrease in outside services associated
with manufacturing related activities, and a $0.1 million decrease in noncash
stock-based compensation.

Sales and marketing costs

                                                Three Months Ended September 30,                     2021 vs. 2020
                                                    2021                   2020                $ Change         % Change
Selling and marketing                        $         30,468          $   14,700          $      15,768               107  %



The increase in selling and marketing expenses was primarily due to a $13.8
million increase in media and marketing costs related to ongoing promotional
strategies, especially those focused on DTC campaigns that commenced in 2021, a
$1.7 million increase in payroll and related expenses due to increased headcount
and sales activities in the field, $0.5 million in the Phexxi sample program,
and a $0.3 million increase in facilities costs. These aggregated increases were
partially offset by a $0.5 million decrease in costs for outside services
associated with marketing and medical affairs activities.

General and administrative expenses

                                                       Three Months Ended September 30,                     2021 vs. 2020
                                                           2021                   2020                $ Change         % Change
General and administrative                         $           4,957          $    7,200          $      (2,243)              (31) %



The decrease in general and administrative expenses was primarily due to a $1.2
million decrease in financing advisory fees and legal fees, a $0.6 million
decrease in outside services primarily related to recruiting, a $0.5 million
decrease in payroll and related expenses due to lower headcount, and a $0.3
million decrease in noncash stock-based compensation. These aggregated decreases
were partially offset by a $0.3 million increase in facilities costs.

Total other income (expense), net

                                               Three Months Ended September 30,                  2021 vs. 2020
                                                   2021                2020                $ Change         % Change
Total other (expense) income, net             $   (30,692)         $   (3,741)         $     (26,951)              720  %



Total other expense, net, for the three months ended September 30, 2021,
primarily included $1.2 million in interest expense related to the convertible
senior secured promissory notes issued to Baker Bros. Advisors LP (the Baker
Notes) and the unsecured convertible promissory notes issued to each of Adjuvant
Global Health Technology Fund, L.P. and Adjuvant Global Health Technology Fund
DE, L.P. (the Adjuvant Notes) as described in   Note 5- Convertible Notes   and
a $29.5 million loss from the change in fair value of the Baker Notes as a
result of mark-to-market adjustments during the current quarter.

Total other charges, net, for the three months ended September 30, 2020, mainly consisted of a $ 3.1 million loss resulting from the change in fair value of the Baker Notes as a result of mark-to-market adjustments and $ 0.7 million in accrued interest on the Baker Notes.

                                       32
--------------------------------------------------------------------------------
  Table of Contents
Nine Months Ended September 30, 2021 Compared to Nine Months Ended September 30,
2020 (in thousands):

Net Product Sales

                                              Nine Months Ended September 30,                   2021 vs. 2020
                                                 2021                 2020               $ Change         % Change
Product sales, net                          $      4,674          $      278          $      4,396             1,581  %



Phexxi was commercially launched in September 2020. The increase in product
sales, net was primarily due to a full nine months of sales in the current
period versus one month of sales in the prior year period, continued growth in
ex-factory unit sales since commercial launch, and an increase in both gross and
net sales from the impact of Phexxi promotional strategies and gross-to-net
initiatives implemented since commercial launch.

Cost of goods sold


                                            Nine Months Ended September 30,                   2021 vs. 2020
                                               2021                 2020               $ Change         % Change
Cost of goods sold                        $      2,300          $      317          $      1,983               626  %


The increase in cost of goods sold is primarily due to nine full months of sales in the current period versus one month of sales in the prior year period.

Research and development costs

                                                    Nine Months Ended September 30,                     2021 vs. 2020
                                                       2021                   2020                $ Change         % Change
Research and development                        $         24,470          $   11,104          $      13,366               120  %



The increase in research and development expenses was primarily due to a $15.4
million increase in clinical trial costs associated with EVOGUARD, and a $0.5
million increase in payroll and related expenses due to increased headcount to
support clinical and regulatory activities. These aggregated increases were
partially offset by a $1.9 million decrease in outside services associated with
manufacturing and regulatory related activities and a $0.6 million decrease in
noncash stock-based compensation.

Sales and marketing costs

                                                 Nine Months Ended September 30,                     2021 vs. 2020
                                                    2021                   2020                $ Change         % Change
Selling and marketing                        $         88,230          $   32,553          $      55,677               171  %



The increase in selling and marketing expenses was primarily due to a $45.3
million increase in media and marketing costs related to ongoing promotional
strategies especially those focused on DTC campaigns that commenced in 2021, a
$9.7 million increase in payroll and related expenses due to increased headcount
and sales activities in the field, $1.7 million in the Phexxi sample program,
and a $1.7 million increase in facilities costs. These aggregated increases were
partially offset by a $2.8 million decrease in costs for outside services
associated with marketing, market access and medical affairs activities, and a
$0.4 million decrease in noncash stock-based compensation.

General and administrative expenses

                                                       Nine Months Ended September 30,                     2021 vs. 2020
                                                          2021                   2020                $ Change         % Change
General and administrative                         $         19,057          $   24,077          $      (5,020)              (21) %



The decrease in general and administrative expenses was primarily due to a $2.6
million decrease in noncash stock-based compensation, a $1.9 million decrease in
financial and recruiting related outside services, a $1.4 million decrease in
financing advisory fees and legal fees, and a $0.3 million decrease in payroll
and related expenses due to lower headcount. These aggregated decreases were
partially offset by a $1.0 million increase in facilities costs.

                                       33
--------------------------------------------------------------------------------
  Table of Contents
Total other income (expense), net
                                                  Nine Months Ended September 30,                     2021 vs. 2020
                                                     2021                   2020               $ Change         % Change
Total other (expense) income, net             $        (24,244)         $  (33,936)         $      9,692               (29) %



Total other expense, net, for the nine months ended September 30, 2021,
primarily included $3.5 million in interest expense related to the Baker Notes
and the Adjuvant Notes as described in   Note 5- Convertible Notes   and a $20.7
million loss from the change in fair value of the Baker Notes as a result of
mark-to-market adjustments in the first half of 2021.

Total other expense, net, for the nine months ended September 30, 2020, mainly
included a $64.0 million loss on issuance of convertible notes, warrants and
purchase rights issued in connection with the Baker Notes, and $1.0 million in
accrued interest expense related to the Baker Notes and the Adjuvant Notes. This
loss was partially offset by a $31.0 million gain from the change in fair value
of the Baker Notes as a result of mark-to-market adjustments.

Liquidity and capital resources

Overview


As of September 30, 2021, we had a working capital deficit of $39.8 million and
an accumulated deficit of $809.1 million. We have financed our operations to
date primarily through the issuance of common stock and warrants, cash received
from private placement transactions, the issuance of convertible notes and, to a
lesser extent, product sales. As of September 30, 2021, we had approximately
$14.9 million in cash and cash equivalents, and $9.0 million in restricted cash
from the Adjuvant Notes that is available for use. Our cash and cash equivalents
include amounts held in checking accounts, money market funds, and investments
in fixed income debt securities with original maturities of less than three
months. We invest cash in excess of immediate requirements in accordance with
our investment policy, which limits the amounts we may invest in any one type of
investment and requires all investments held by us to maintain minimum ratings
from Nationally Recognized Statistical Rating Organizations so as to primarily
achieve liquidity and capital preservation.

We have incurred losses and negative cash flows from operating activities since
inception. During the nine months ended September 30, 2021, we received net
proceeds of approximately $81.5 million upon the sale and issuance of common
stock and warrants to purchase common stock from two underwritten public
offerings that occurred in March and May of 2021. In October 2021, we received
net proceeds of approximately $9.7 million from a registered direct offering.

We anticipate that we will continue to incur net losses for the foreseeable
future. We expect research and development expenses to be significantly higher
in 2021 compared to 2020 due to our Phase 3 EVOGUARD study, which was initiated
in October 2020. We expect selling and marketing expenses to increase
significantly in 2021 compared to 2020 due to the deployment of our commercial
sales force that was established in the third quarter of 2020 and as we execute
associated promotional strategies and initiatives, including our DTC programs.
Lastly, we expect general and administrative expenses to decrease slightly in
2021 compared to 2020 due to lower recruiting fees and financing advisory fees.

We currently expect our liquidity resources as of September 30, 2021 together
with the net proceeds of the registered direct offering completed in October
2021, to be sufficient to fund our planned operations into the first quarter of
2022. The uncertainties associated with our ability to obtain additional equity
financing on terms that are favorable to us or at all, enter into collaborative
agreements with strategic partners, and succeed in our future operations raise
substantial doubt about our ability to continue as a going concern. In addition,
the COVID-19 pandemic caused us to delay the commercial launch of Phexxi until
September 2020. Also, due in part to the impact of the COVID-19 pandemic, the
completion of enrollment in the Phase 3 EVOGUARD study is now expected in the
first quarter of 2022 and we expect to report top-line EVOGUARD results in the
third quarter of 2022. Our ability to raise additional funds, and the terms on
which those funds may be raised, will be dependent, in part, on how successful
the commercialization of Phexxi is, whether we are able to gain revenue traction
prior to raising such additional funds, and the success of our research and
development efforts, including our ability to develop EVO100. If the COVID-19
pandemic continues to disrupt and negatively impact the commercialization of
Phexxi or our research and development efforts, our ability to raise additional
funds may be negatively impacted, or we may not be able to obtain funding on
terms favorable to us or at all.

If we are not able to obtain required additional funding when and as needed,
through equity financings or other means, or if we are unable to obtain funding
on terms favorable to us, the shortfall in funds raised, or such unfavorable
terms, will likely have a material adverse effect on our operations and
strategic plan for future growth. If we cannot successfully raise the funding
necessary to implement our current strategic plan, we may be forced to make
reductions in spending, suspend or terminate development programs, extend
payment terms with suppliers, liquidate assets where possible, suspend or
curtail planned programs, and/or cease operations. Any of these developments
would materially and adversely affect our financial
                                       34
--------------------------------------------------------------------------------
  Table of Contents
condition and business prospects and could even cause us to be unable to
continue as a going concern. If we are unable to continue as a going concern, we
may have to liquidate our assets and, in doing so, we may receive less than the
value at which those assets are carried on our financial statements. Any of
these developments would materially and adversely affect the price of our stock
and the value of your investment.

The opinion of our independent registered public accounting firm on our audited
financial statements as of and for the years ended December 31, 2020 and 2019
contains an explanatory paragraph regarding substantial doubt about our ability
to continue as a going concern. Future reports on our financial statements may
include an explanatory paragraph with respect to our ability to continue as a
going concern. Our unaudited condensed consolidated financial statements as of
September 30, 2021 and for three and nine months ended September 30, 2021 and
2020 included in this Quarterly Report do not include any adjustments relating
to the recoverability and classification of recorded asset amounts or amounts of
liabilities that might be necessary should we be unable to continue our
operations.

2021 equity financing


As described in   Note 10- Stockholders' Equity (Deficit)  , we received
proceeds of approximately $28.0 million, net of underwriting discounts, from a
public offering in March 2021, upon the issuance of 17,142,857 shares of our
common stock, and approximately $4.2 million, net of underwriting discounts,
from the issuance of 2,571,428 shares of common stock upon exercise of the
underwriters' overallotment option in April 2021.

As described in   Note 10- Stockholders' Equity (Deficit)  , we received
proceeds of approximately $46.8 million, net of underwriting discounts and fees,
from a public offering in May 2021, upon the issuance of 50,000,000 shares of
common stock and common warrants to purchase 50,000,000 shares of common stock.
We received approximately $2.4 million and $0.1 million, both net of
underwriting discounts, from the issuance of 2,547,794 shares of common stock
and 7,500,000 common warrants, respectively, upon exercise of the underwriter's
overallotment option in May 2021.

As described in Note 10 – Equity (Deficit), we received proceeds of approximately $ 9.7 million, net of offering costs, of a direct placement registered in October 2021, upon the issuance of 5,000 shares of Series B-1 Convertible Preference Shares and 5,000 shares of Series B-2 Convertible Preference Shares.

Debt financing and equity 2020


As described in   Note 5- Convertible Notes  , we received aggregate gross
proceeds of $25.0 million upon the first and second closings of convertible
senior secured promissory notes pursuant to the Securities Purchase and Security
Agreement with certain affiliates of Baker Bros. Advisors LP as purchasers
during the second quarter of 2020. We also received gross proceeds of $25.0
million from the closing of convertible unsecured promissory notes pursuant to
the Adjuvant Purchase Agreement during the fourth quarter of 2020.

As described in   Note 10- Stockholders' Equity (Deficit)  , we received net
aggregate proceeds of $103.7 million in June 2020 upon the issuance and sale of
31,700,000 shares of our common stock from our 2020 Public Offering and net
aggregate proceeds of $3.8 million during the first half of 2020 upon the
issuance and sale of 676,656 shares of our common stock pursuant to the "at the
market" (ATM) program. The ATM program was terminated in June 2020.

© Edgar online, source Previews


Source link

]]>