Evofem Biosciences Inc (EVFM) 2022 Q2 法說會逐字稿

Good afternoon. Now I'll turn the call over to Amy Raskopf, Evofem Biosciences' Vice President of Investor Relations. Please go ahead.

午安.現在我將把電話轉給Evofem Biosciences投資者關係副總裁Amy Raskopf。請您發言。

Thank you, Larry. Good afternoon, everyone, and welcome to the Evofem Biosciences' results call for the Second Quarter of 2022. If you haven't done so already, I encourage you to access the presentation that accompanies this call and the press release we issued after market close, both of which may be found at evofem.com under the Investors tab.

謝謝，拉里。大家下午好，歡迎參加Evofem Biosciences 2022年第二季業績電話會議。如果您還沒有看過，我建議您查看本次電話會議的簡報以及我們在收盤後發布的新聞稿，這兩份文件都可以在evofem.com的「投資者」標籤頁下找到。

Before we begin, I would like to remind you that remarks made on this call will contain forward-looking statements, which are made only as of today, August 4, 2022. For a more detailed description of important risk factors that could cause our actual results to differ materially, please refer to our annual report on Form 10-K and our most recently filed 10-Q. Also, we will discuss estimates and other statistical data made by independent parties and by company relating to the market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

在開始之前，我想提醒您，本次電話會議中的評論將包含前瞻性陳述，這些陳述僅截至今天（2022年8月4日）有效。有關可能導致我們實際業績出現重大差異的重要風險因素的更詳細說明，請參閱我們的10-K表格年度報告和我們最近提交的10-Q表格。此外，我們將討論獨立機構和公司就市場規模和成長以及其他行業數據提供的估計值和其他統計數據。這些數據涉及一些假設和限制，請注意不要過度依賴此類估計值。

With that, I'll turn the call over to Evofem's CEO, Saundra Pelletier.

說完這些，我將把電話轉給 Evofem 的執行長 Saundra Pelletier。

Thank you, Amy. And thank you to everyone for joining us today. Today we are reporting another strong quarter of improved operating results, highlighted by a 42% increase in Phexxi net product sales. We reduced our total operating expenses by 8%. We narrowed our loss from operations by 16%. And we expect further growth in Q3 and beyond driven by ongoing penetration of the $7.9 billion U.S. contraceptive market. For those of you that are new to Evofem and as an important reminder, our innovative non-hormonal contraceptive product Phexxi is the first and the only FDA approved women controlled product that does not impact a woman's ovaries in any way. Nor does it prevent implantation of a fertilized egg. With the growing awareness of Phexxi and the concerns amongst women about sustainable access to contraception, Evofem is poised to capitalize on the current environment.

謝謝你，艾米。也感謝大家今天加入我們。今天，我們報告了本季強勁的營運業績成長，其中 Phexxi 淨產品銷售額成長了 42%。我們將總營運費用降低了 8%。我們將營運虧損縮小了 16%。我們預計，在 79 億美元美國避孕市場的持續滲透的推動下，第三季及以後的業績將進一步成長。對於那些剛接觸 Evofem 的人來說，需要特別提醒的是，我們創新的非荷爾蒙避孕產品 Phexxi 是第一個也是唯一獲得 FDA 批准的女性管制產品，它不會以任何方式影響女性的卵巢。它也不會阻止受精卵著床。隨著 Phexxi 意識的不斷提高以及女性對永續避孕途徑的擔憂，Evofem 已準備好利用當前的環境。

With that, I will ask our CFO, Jay File to review the financial results. Jay?

有了這些，我會請我們的財務長傑伊·菲爾 (Jay File) 審查財務結果。傑伊？

Thank you, Saundra. Today, I'm going to focus on the second quarter of 2022 results relative to the first quarter of 2022. Net product sales increased 42% to $6 million driven by higher ex-factory sales. And gross to net was 40% for the second quarter of 2022 and we continue to expect GTN will remain about this level or better. Total operating expenses decreased 8% to $30.5 million. This was mainly driven by lower R&D costs, which were $7.7 million in Q2. The decrease reflects lower costs of the Phase 3 EVOGUARD trial as participants completed and exited the study.

謝謝桑德拉。今天，我將重點介紹2022年第二季相對於2022年第一季的業績。受出廠銷售額成長的推動，淨產品銷售額成長42%，達到600萬美元。 2022年第二季的毛淨銷售額比率為40%，我們預期GTN將維持在這一水準或更高水準。總營運費用下降8%，至3050萬美元。這主要得益於研發成本的降低，第二季研發成本為770萬美元。這一下降反映了EVOGUARD 3期臨床試驗成本的降低，因為參與者已經完成並退出了研究。

We expect R&D costs to come down in the third quarter since the last patient visit was completed in late July. R&D costs should be significantly lower in Q4 and beyond. Selling and marketing costs were $400,000 lower in Q2, while G&A costs were up $100,000 due to legal fees. As a result of a higher revenue and lower operating expenses, our loss from operations improved 16% to $24.4 million.

我們預計，自7月底完成最後一次病患就診以來，第三季研發成本將會下降。第四季及以後，研發成本應該會大幅下降。第二季銷售和行銷成本減少了40萬美元，而由於法律費用，一般及行政費用增加了10萬美元。由於收入增加和營運費用下降，我們的營運虧損減少了16%，至2,440萬美元。

We continue to expect 2022 net product sales will be in the range of USD30 million to USD35 million, with momentum building in the second half of the year. This represents 264% to 325% growth year-over-year. We expect gross to net will be 40% or better, trending lower in the second half of the year. We remain on track to reduce costs by $50 million in 2022. Our total operating expenses were $25.3 million lower in the first half of the year versus the same period of 2021. Finally, we still expect to be cash flow breakeven on a quarterly basis, no later than the end of 2023.

我們預計2022年淨產品銷售額將在3,000萬美元至3,500萬美元之間，下半年成長動能將增強。這意味著同比增長264%至325%。我們預計毛淨銷售額比將達到40%或更高，下半年將有所下降。我們仍有望在2022年將成本削減5,000萬美元。今年上半年，我們的總營運支出較2021年同期減少了2,530萬美元。最後，我們預計最遲在2023年底實現季度現金流損益兩平。

During the second quarter, we raised net proceeds of $18.1 million from an underwritten public offering and $2 million from our equity line of credit which we terminated in May. Through August 3, 2022, we received $22.4 million from exercise of common warrants that were issued in the main public offering. At the close of Q2, we had $19.9 million in unrestricted cash and $1.6 million in restricted cash. Based on our current expected operations, we believe we have sufficient cash to fund operations into Q4. This does not include potential non-dilutive capital. For commercial alternatives, we are exploring and evaluating to an end shareholder value like U.S. co-marketing and co-promotion partnerships.

在第二季度，我們透過承銷公開發行籌集了1,810萬美元的淨收益，並透過我們於5月終止的股權信用額度籌集了200萬美元。截至2022年8月3日，我們透過行使在主要公開發行中發行的普通股認股權證獲得了2,240萬美元。在第二季末，我們擁有1,990萬美元的非限制性現金和160萬美元的限制性現金。根據我們目前的預期營運情況，我們相信我們擁有足夠的現金來支援第四季度的營運。這不包括潛在的非稀釋性資本。對於商業替代方案，我們正在探索和評估最終股東價值，例如在美國建立聯合行銷和聯合推廣夥伴關係。

We continue our efforts to regain compliance with the NASDAQ Capital Market minimum bid requirements. In May we closed above $1 for 10 consecutive trading days as required by the NASDAQ listing term. However, the panel took the unexpected step of disregarding Evofem's achievement of this compliance milestone. Ultimately, the panel granted our request for continued listing of our shares on the NASDAQ Capital Market, without requiring a second reverse stock split, provided the company is able to evidence a closing bid price of at least $1 per share For at least 10 consecutive trading days by August 22nd. Given our solid Q2 results, we hope for strong support from investors who see our ongoing growth in the $7.9 billion contraceptive market and the upside opportunity in STI prevention, I believe Evofem is a smart investment, especially at the current share price.

我們將繼續努力重新遵守納斯達克資本市場的最低出價要求。 5 月份，我們按照納斯達克上市條款的要求，連續 10 個交易日收盤價高於 1 美元。然而，委員會出人意料地無視 Evofem 達到這一合規里程碑。最終，委員會批准了我們的請求，繼續在納斯達克資本市場上市，無需進行第二次反向股票分割，前提是公司能夠在 8 月 22 日之前至少連續 10 個交易日證明收盤價至少為每股 1 美元。鑑於我們第二季度的穩健業績，我們希望得到看到我們在 79 億美元避孕市場中的持續增長以及性傳播感染預防方面的上行機會的投資者的大力支持，我相信 Evofem 是一項明智的投資，尤其是在目前的股價下。

And with that, I'll turn it back over to Saundra.

說完這些，我將把麥克風交還給桑德拉。

Building on what Jay said, since April 1st, we have announced 16 positive developments that will all favorably impact our go forward business and enhance our ability to deliver long-term shareholder value. We have presented and published 4 new datasets on Phexxi to the medical community. The most important of these was data demonstrating that Phexxi prevented 99% of pregnancies per active sex in the Phase 3 AMPOWER clinical trial, which is resonating with healthcare providers and women alike. This should increase uptake, translating into prescription growth.

基於Jay所說的，自4月1日以來，我們已宣布了16項積極進展，這些進展都將對我們未來的業務產生積極影響，並增強我們為股東創造長期價值的能力。我們已向醫學界展示並發布了4個關於Phexxi的新資料集。其中最重要的一項數據表明，在AMPOWER三期臨床試驗中，Phexxi在每次活躍性行為中成功預防了99%的懷孕，這引起了醫療保健提供者和女性的共鳴。這應該會增加Phexxi的用量，轉化為處方藥的成長。

As an organization, we proactively developed and launched a new educational birth control chart covering all available methods to assist providers in patient contraceptive counseling. It replaces a far outdated chart many OB-GYN still had on their wall, which was developed before new contraceptive methods like Phexxi came to the market. It assists healthcare providers to deliver patient centered care. Better and more informed counseling should increase utilization, translating to prescription growth of Phexxi.

我們積極開發並推出了一套涵蓋所有可用避孕方法的全新避孕教育圖表，旨在幫助醫護人員為患者提供避孕諮詢。它取代了許多婦產科醫生仍在牆上掛著的過時圖表，這些圖表是在 Phexxi 等新型避孕方法上市之前開發的。它可以幫助醫護人員提供以病人為中心的醫療服務。更優質、更明智的諮詢服務應該能夠提高藥物利用率，從而促進 Phexxi 的處方成長。

Media coverage of Evofem and Phexxi spiked dramatically since June, including features in People Magazine, NBC News, CNN and more. We partnered with A360 Media placing Phexxi branded content in their widely read entertainment and lifestyle magazines on every shelf, as well as online media. Moving forward the Phexxi manufacturing partnership is expected to decrease our cost of goods up to 45%. The FDA extended Phexxi shelf life to 4 years. A new patent was allowed covering Phexxi's Composition of Matter and providing protection through at least 2033. And we also strengthened our leadership team and our Board of Directors.

自六月以來，媒體對 Evofem 和 Phexxi 的報導大幅增加，包括《人物》雜誌、NBC 新聞、CNN 等媒體的報導。我們與 A360 Media 合作，將 Phexxi 品牌內容投放到其廣受歡迎的娛樂和生活雜誌中，這些雜誌遍布各大書架，並刊登在網路媒體上。未來與 Phexxi 的生產合作預計將使我們的商品成本降低高達 45%。 FDA 將 Phexxi 的保存期限延長至 4 年。一項涵蓋 Phexxi 物質成分的新專利獲得批准，保護期至少持續到 2033 年。我們也加強了領導團隊和董事會的實力。

We continue to secure coverage for Phexxi with payers. Our largest win is a long-term contract with one of the largest PBMs in the nation that added Phexxi to its national template formulary with no restrictions. This is significant, and we look forward to increase Phexxi prescriptions among this PBM's 28 million participants. This agreement is also expected to save us upwards of $1 million a year by removing prior authorizations from Phexxi prescriptions for this PBM. Each prior authorization was costing us $35 to process and we're delighted to remove this cost from our operating expense. Our approved claim rate has continued to increase through 2022 and currently more than 70% of Phexxi prescription claims are being approved. Every new agreement means more women are able to fill and refill their Phexxi prescriptions and we look forward to the positive impact this will have on Phexxi growth.

我們持續確保Phexxi的健保覆蓋範圍，確保其與付款方的良好關係。我們最大的勝利是與全美最大的藥品福利管理機構之一簽訂了一份長期合同，該機構將Phexxi納入其國家處方集，且無任何限制。這意義重大，我們期待在該藥品福利管理機構2,800萬參與者中增加Phexxi的處方。該協議也預計將透過取消該藥品福利管理機構Phexxi處方的預先授權，每年為我們節省100萬美元以上。之前，每份預先授權的處理成本為35美元，我們很高興能夠從營運費用中取消這筆成本。我們的理賠核准率將在2022年持續成長，目前超過70%的Phexxi處方理賠獲得批准。每項新協議都意味著更多女性能夠自行配藥和續藥，我們期待這將對Phexxi的成長產生正面影響。

The biggest catalyst that the market responded to was the Supreme Court ruling on Roe versus Wade on June 24. The media focus on contraception in the wake of this decision provided a tailwind to Evofem by increasing visibility among investors, as well as consumers. This has created a tremendous opportunity for our company.

市場反應最強烈的催化劑是6月24日最高法院對羅訴韋德案的裁決。這項裁決引發了媒體對避孕問題的關注，這為Evofem帶來了助力，提高了其在投資者和消費者中的知名度。這為我們公司創造了巨大的機會。

Many of you who are new to the stock since that day, I want to welcome those of you. And for those of you that have been with us for a while, I want to thank you for your continued support as we build on these accomplishments. Q2 was another consecutive quarter of increasing net product sales and improved operating loss. We are consistently delivering growth quarter-over-quarter. This directly reflects the heightened recognition of Phexxi's innovative attributes among women and prescribers and growing traction with insurers. We expect another strong quarter in Q3. Based on the current trends and the indicators, and as Jay mentioned, we remain on track to achieve our 2022 revenue guidance of USD30 million to USD35 million.

很多從那天起才開始關注我們股票的朋友，我向你們表示熱烈的歡迎。而對於那些已經與我們合作了一段時間的朋友，我要感謝你們一直以來的支持，讓我們在這些成就的基礎上再接再厲。第二季度，我們的淨產品銷售額連續第二季成長，營運虧損也得到改善。我們持續保持環比增長。這直接反映了女性和處方醫生對 Phexxi 創新特性的認可度不斷提高，以及保險公司對其日益增長的吸引力。我們預計第三季將再次表現強勁。根據目前的趨勢和指標，正如 Jay 所提到的，我們仍有望實現 2022 年 3,000 萬至 3,500 萬美元的收入預期。

Last week, following President Biden's executive order on ensuring access to reproductive healthcare, the U.S. Departments of Health and Human Services, Labor and the Treasury released guidance clarifying that group health plans at insurers must cover contraceptives at no cost to individuals. The ACA guarantees coverage of women's preventive services, including free birth control and contraceptive counseling for all individuals and covered dependents with reproductive capacity. This encompasses all contraceptives like Phexxi that are approved, granted or cleared by the FDA. So what does this mean for Evofem? It means more plans covering Phexxi at no cost to women, and it means them doing that sooner with no restrictions. It means less money that goes to copay programs that increases our profitability of every Phexxi prescription.

上週，拜登總統發布關於確保生殖保健可及性的行政命令後，美國衛生與公眾服務部、勞工部和財政部發布了指導意見，明確規定保險公司的團體健康計劃必須免費承保個人避孕藥具。 《平價醫療法案》保證為所有具有生育能力的個人及其受保家屬提供女性預防性服務，包括免費的避孕和避孕諮詢。這涵蓋了所有經FDA批准、授權或核准的避孕藥具，例如Phexxi。那麼，這對Evofem意味著什麼？這意味著將有更多計劃免費承保Phexxi，女性可以更快地享受這項服務，而且沒有任何限制。這意味著用於共付額項目的資金減少，從而提高了我們每張Phexxi處方的獲利能力。

Evofem's market access team is having renewed discussions with insurers and PBMs that were previously non-compliant with these guidelines to advance the removal of impermissible barriers, such as step edits, claim denials, and prior authorization letters to ensure that women have access to Phexxi at no out of pocket costs. As a reminder, there are 42.2 million potential Phexxi users in the United States. The total contraceptive market is estimated to be $7.9 billion. Every 1% market share of the 42.4 million women in our addressable market represents significant net product sales for Evofem. Those of you who are looking at this slide, it is one of my favorite. At our current WAC of $294 per box of 12 Phexxi applicators, applying the Q2 gross to net of 40%, we net a $176.40 per box. If we're being conservative, and women only get 4 boxes of Phexxi per year, each 1% market share equals $298 million in Phexxi sales. However, the reality is that most providers write a six month prescription. So when women get six boxes of Phexxi per year, each 1% market share equals $447 million in Phexxi net sales. And when our gross to net improves to 35%, the economics are even more favorable. And we also know a number of women are getting far beyond six month prescription. Contraception is a profitable business. Especially though for a company with an FDA approved proprietary product with no generic competition or equivalent.

Evofem 的市場准入團隊正在與先前不遵守這些準則的保險公司和 PBM 重新進行討論，以推動消除不允許的障礙，例如步驟編輯、索賠拒絕和事先授權書，確保女性能夠免費使用 Phexxi。提醒一下，美國有 4,220 萬潛在的 Phexxi 用戶。整個避孕市場估計為 79 億美元。我們目標市場中 4,240 萬名女性的每 1% 的市佔率都代表著 Evofem 可觀的淨產品銷售。你們中正在看這張投影片的，這是我最喜歡的投影片之一。我們目前的加權平均成本為每盒 12 個 Phexxi 塗藥器 294 美元，將第二季的毛利率乘以 40% 的淨利率，我們每盒淨賺 176.40 美元。如果我們保守估計，假設女性每年只買4盒Phexxi，那麼每1%的市佔率就等於Phexxi銷售額2.98億美元。然而，現實情況是，大多數供應商開的是六個月的處方藥。因此，如果女性每年購買6盒Phexxi，那麼每1%的市佔率就相當於Phexxi淨銷售額4.47億美元。當我們的毛利/淨利比提高到35%時，經濟效益將更加可觀。而且我們也知道，很多女性的處方藥購買量遠遠超過了六個月。避孕是一項利潤豐厚的生意，尤其對於一家擁有FDA批准的專有產品且沒有仿製藥或同類產品的公司而言。

Moving on to the program that we expect to double our market opportunity, providing significant upside for shareholders and women is our EVOGUARD study, because every sexually active woman is at risk for STI infection. On Monday of this week, we announced the last patient visit in our registrational Phase 3 clinical trial evaluating Phexxi for the prevention of chlamydia and gonorrhea in women. Success in STI prevention would expand our market opportunity beyond women in their reproductive years. Research has indicated that 2/3 of current lubricant users would replace their lubricant with Phexxi if approved for the prevention of chlamydia and gonorrhea.

我們接下來要說的是 EVOGUARD 研究，它預計將使我們的市場機會翻倍，並為股東和女性帶來巨大的收益。因為每位性活躍的女性都面臨性傳染感染的風險。本週一，我們宣布了 Phexxi 註冊性 3 期臨床試驗的最後一位患者就診，該試驗旨在評估 Phexxi 在女性衣原體感染和淋病預防中的應用。如果 Phexxi 在性傳染感染預防方面取得成功，我們的市場機會將擴展到育齡女性以外的領域。研究表明，如果 Phexxi 獲得批准用於預防衣原體感染和淋病，目前 2/3 的潤滑劑使用者會將他們的潤滑劑替換為 Phexxi。

An additional study found that 49 million Americans used personal lubricants in 2022. 20% of people in the United States had an STI on any given day in 2018. The CDC estimates 4 and 1.6 million new cases of chlamydia and gonorrhea respectively, and all of those occurred last year. Infected people are often unaware of and don't seek treatment for their infections. Chlamydia is the most frequently reported bacterial infection in the U.S. Almost 60% of women infected with chlamydia have no symptoms. Yet it's one of the leading causes of infertility in the U.S., which we know is emotionally and financially daunting. There are no FDA approved women controlled prophylactics to prevent these STIs. The CDC states that all sexually active people are at risk. The need here is enormous. Regardless of the contraceptive product women are choosing, they are still at risk. This widens the market opportunity for shareholders and women significantly.

另一項研究發現，2022 年有 4,900 萬美國人使用個人潤滑劑。 2018 年，美國有 20% 的人每天都會感染性傳染病。美國疾病管制與預防中心估計，美國披衣菌感染和淋病新發病例分別為 400 萬和 160 萬，所有這些病例都發生在去年。感染者往往不知情，也不會尋求治療。衣原體是美國最常見的細菌感染。近 60% 的披衣菌感染女性沒有症狀。然而，衣原體是美國不孕症的主要原因之一，我們知道，不孕症會給人們帶來情感和經濟上的雙重打擊。目前還沒有經 FDA 批准的女性專用避孕藥來預防這些性傳染病。美國疾病管制與預防中心指出，所有性活躍族群都面臨風險。這方面的需求龐大。無論女性選擇哪種避孕產品，她們仍面臨風險。這大大拓寬了股東和女性的市場機會。

We're on track to report our top line Phase 3 study data in October. We expect positive outcomes would enable us to submit regulatory applications to the FDA in the first half of 2023. These will be sNDA filings seeking to add prevention of chlamydia and gonorrhea in women to Phexxi's label. We have Fast Track designation for both potential and new indications, so we could receive FDA approval for these indications in 2023.

我們預計在10月公佈3期臨床試驗的最終數據。我們預計，積極的研究結果將使我們能夠在2023年上半年向FDA提交監管申請。這些申請將是補充新藥申請 (sNDA)，旨在將預防女性衣原體感染和淋病的功能添加到Phexxi的產品標籤中。我們已獲得潛在適應症和新適應症的快速通道資格，因此這些適應症預計將在2023年獲得FDA的批准。

I'd like to point out that we believe our current valuation does not reflect the opportunity we are addressing with Phexxi in the $7.9 billion U.S. contraceptive market. It does not factor in the near term upside potential in STI prevention. We believe this presents an incredible opportunity for the right investor. And we hope that we can count on your support.

我想指出的是，我們認為目前的估值並未反映Phexxi在79億美元美國避孕藥市場中蘊含的機會。它並未將性傳染感染預防領域的短期上漲潛力納入考量。我們相信，對於合適的投資者來說，這是一個絕佳的機會。我們希望能夠得到您的支持。

With that operator, please open the call to questions.

請與該接線員聯繫，開始提問。

(Operator Instructions) The first one is from David Amsellem, Piper Sandler.

（操作員指示）第一個來自 David Amsellem、Piper Sandler。

So, I joined late, so you may have addressed this Saundra. But the first question I had is, since the overturning of Roe v. Wade, what are you hearing in the field in terms of just level of interest and not just from practitioners, but also from patients? That's number one.

所以，桑德拉，我加入得晚了，所以你可能已經回答了這個問題。但我的第一個問題是，自從羅訴韋德案被推翻以來，你聽到的關於該領域的興趣程度如何？不只是來自執業醫生，還有病人？這是第一個問題。

And then number two, different question, this is on the gross to net, which I feel like I always ask but I need to, and that is, with the contracting and with the environment being what it is, for the better, of course, how should we think about steady state beyond this year?

然後第二個問題，不同的是，這是總額與淨額的比率，我覺得我總是問這個問題，但我需要問，也就是說，隨著合約的簽訂和環境的改善，當然，我們應該如何考慮今年以後的穩定狀態？

So I will start, and then I will have Jay to talk about gross to net. So here's what we're hearing in the field. I mean, as you would expect, there is a heightened sense of urgency since the Supreme Court decision on abortion. We are hearing more and more interest from healthcare providers in wanting to meet with our sales team and wanting to know and understand the entire offerings that Evofem has. We also are actually having a lot of HCPs, depending on their state, talking about what might end up being less choices that they will have available to offer to women.

那我先開始，然後我會請傑伊談談總收入與淨收入的比例。以下是我們在這個領域聽到的消息。我的意思是，正如你所預料的那樣，自從最高法院就墮胎做出裁決以來，人們的緊迫感增強了。我們聽到越來越多的醫療保健提供者希望與我們的銷售團隊會面，並希望了解和理解Evofem提供的所有產品。實際上，我們也有很多醫療保健專業人士（根據他們所在的州）在談論，他們最終可能會為女性提供的選擇減少。

And so rolling out this educational birth control chart, and I don't know if you were on at that point, David, but one of the things that's happened for more than 10 years, there has been no update to this patient counseling chart. And when you're in a waiting room, and you're frankly nude from the waist down waiting for your doctor to come in, and you're staring at the wall or the ceiling, oftentimes, these charts really show women what are their choices, what is the myriad of choices, and what choice is best for them?

所以推出了這份教育避孕圖表。我不知道大衛，當時你有沒有參與，但十多年來，一直沒有更新這份病患諮詢圖表。當你在候診室裡，腰部以下赤裸著等待醫生進來，盯著牆壁或天花板時，這些圖表往往能真正告訴女性她們有哪些選擇，在眾多選擇中，哪個選擇對她們來說才是最好的？

So we took proactively upon ourselves. In fact, our Chief Commercial Officer was into the field and repeatedly saying that, "Look, these are outdated charts. If anybody wants to counsel a woman, they're so busy in their day. Isn't it better?" So the charts have been ineffective. As an example, we have reps calling in and saying that they brought in one or two charts, we have offices calling us constantly saying we have eight exam rooms, we need at least eight charts.

所以我們主動承擔了責任。事實上，我們的首席商務官親自前往現場，反覆強調：「你看，這些圖表都過時了。如果有人想給女性諮詢，他們一天都忙得不可開交。這樣不是更好嗎？」 所以這些圖表一直沒有起到作用。例如，我們的銷售代表打電話來，說他們帶了一兩張圖表；我們的辦公室也不斷打電話來，說我們有八個檢查室，我們至少需要八張圖表。

So we're hearing that counseling women has become much more pervasive than before. Of course, some doctors, counsel patients, but now even the ones that weren't counseling as much are counseling more, because women are nervous, and they want to know about sustainable access. We've heard a lot of people coming in saying they're worried about maybe what they're using might not be available, and should they start to switch to something else. But one of the biggest things that we have heard is that, as physicians understand that our product does not do anything to negatively impact a woman's ovaries, there has been an interesting focus. The doctors who are writing Phexxi perhaps for breastfeeding women, or for cancer patients, or for women who just can't use hormones are now expanding their mind to say, "You know what I need to broaden who I think the Phexxi woman is" And the biggest lever for that was this analysis we did that showed that based on per active sex that 99% of the time Phexxi prevented pregnancy.

因此，我們聽說女性諮詢服務比以前更普及。當然，有些醫生會為患者提供諮詢，但現在，即使是以前不怎麼提供諮詢的醫生也開始提供更多諮詢，因為女性感到焦慮，她們希望了解藥物的可持續獲取途徑。我們聽到很多人來諮詢，說他們擔心自己正在使用的藥物可能買不到，或是否應該換其他藥物。但我們聽到的最重要的一點是，由於醫生們明白我們的產品不會對女性卵巢產生任何負面影響，因此出現了一個有趣的關注點。那些為哺乳期女性、癌症患者或無法使用荷爾蒙的女性開立 Phexxi 的醫生，現在正在拓展思路，他們會說：「你知道我需要拓寬對 Phexxi 女性的認知嗎？」而最大的推動力是我們所做的分析，該分析顯示，基於每次活躍性行為，Phexxi 避孕的幾率高達 99%。

So I would say that, for us, it is bittersweet. I mean, come on, I run a women's healthcare company. Obviously, this kind of decision was tough. We expected it though. But I would tell you that the increase in interest for Phexxi has been very significant. And so that's what we're hearing.

所以我想說，對我們來說，這真是苦樂參半。我是說，我經營的是一家女性保健公司。顯然，做出這樣的決定很難。雖然我們預料到了。但我要說的是，人們對 Phexxi 的興趣成長非常顯著。這就是我們所聽到的。

But the final thing I would say is that we are hearing though a lot of trepidations, depending on where the states are, where some of these representatives are, where people are starting to brace themselves. They're hoping that it doesn't go further than just the decision on abortion. But people are already starting to brace themselves and be skeptical about what might be next. You want to talk about GTN?

但最後我想說的是，我們聽到了很多擔憂，這取決於各州的立場、一些議員的立場以及人們開始準備的地方。他們希望事情不會超出墮胎決定的範圍。但人們已經開始做好準備，並對接下來可能發生的事情感到懷疑。你想談談GTN嗎？

Sure. To follow-up on your GTN question, still always valid, so go keep on asking it. We were very pleased obviously to see GTN maintain its consistency as we believed it would at the end of Q1 in that 40% range. We are reaffirming guidance that we do anticipate that continuing through the end of the year and a very strong possibility to see it lower as the year goes on. That is largely attributable to not only the new PBM contract but some of the other wins that you saw reported on some of our press releases obviously during the quarter. And then we have summarized here.

當然。關於您關於GTN的問題，這個問題一直有效，所以請繼續提問。我們非常高興地看到GTN保持了其穩定性，正如我們預期的那樣，在第一季末它將保持在40%的範圍內。我們重申我們的指導方針，我們預計這種狀況將持續到年底，並且很有可能隨著時間的推移而下降。這主要歸功於新的PBM合同，以及您在本季度一些新聞稿中看到的其他一些成功案例。我們在這裡進行了總結。

Why those are important is because you start seeing them come through with less utilization of our copay programs. And why that is so significant is, of that 40%, a little less than half of that is attributable to our copay programs. So anytime you can obviously start chipping away of that, that's going to have a direct benefit to our net revenue number on every sale of Phexxi as it goes forward. Now, there's always going to be costs associated with distributor, and other administrative costs that flow through, those are never going to go away. But with volume increases, in the next few year, we do anticipate we could probably negotiate down some distributor costs. But in lieu of that, we do know that ultimately a good 20% to 25% is probably here to stay for the timebeing as a cost of doing business. But we do think that ultimately over the next few years, we can get down to 35%. And 30% is a reality at some point in the near future. And then some of it, I do expect us to give updated guidance at the time next year when we see full ACA mandate coming through, we get a little bit of headwind and actuals coming through and see just how significant that impact is.

這些措施之所以重要，是因為你會看到，隨著我們自付費用計畫的使用率下降，這些措施的效果會逐漸顯現。而這之所以意義重大，是因為在這40%中，只有不到一半的自付費用計畫的貢獻率更高。所以，只要你能逐步削減這部分支出，就能直接提升我們未來每銷售一瓶Phexxi的淨收入。現在，經銷商成本以及其他管理成本是不可避免的，這些成本永遠不會消失。但隨著銷售量的成長，在未來幾年，我們預期或許可以協商降低一些經銷商成本。但同時，我們知道，作為一項經營成本，20%到25%的水平可能暫時保持不變。但我們認為，在未來幾年，我們最終可以將其降至35%。在不久的將來，30%的目標也將實現。然後，我確實希望我們能夠在明年看到 ACA 全面實施時提供更新的指導，我們會遇到一些阻力，實際情況也會隨之而來，看看這種影響有多大。

We'll always have public, private mix. We'll always have plans that are exempt from ACA, that's always going to be there. But we don't think those will have a negative impact on GTN and we do see continued improvement as we look forward.

我們將始終保持公私混合模式。我們將始終提供不受《平價醫療法案》（ACA）影響的計劃，這些計劃將始終存在。但我們認為這些計畫不會對GTN產生負面影響，而且我們確實看到了GTN在未來的持續改善。

Does that answer your question, David?

這回答了你的問題嗎，大衛？

All right. We do have another question coming in from I-Eh Jen, Laidlaw and Company.

好的。我們還有一個問題，來自 I-Eh Jen, Laidlaw and Company。

The first question is that, it's certainly a great quarter, last quarter. Are you guys going to review what's the script numbers in the last quarter? And then I have follow-up questions.

第一個問題是，上個季度確實很棒。你們會回顧一下上個季度的劇本數量嗎？然後我還有一些後續問題。

Well, here's what we can tell you. We can tell you that quarter-over-quarter, we have seen a 11% and 12% growth. So we've seen an increase. And one of the things that we have done as we shared on the call, is for example, when we rolled out the A360 Media rollout, it drove a 16% spike in demand just after the initial 2 weeks. And so what we have been seeing is that we are seeing growth, we have actually seen a lot of people and distributors and wholesalers getting ready for the rollout that just happened. We did a whole series of interviews with Annie Murphy, that's gotten a lot of media attention. There's a lot more media rollout to come as a result of those interviews. So particularly also July 1st was the day that this largest PBM came on board with no restrictions. So we really feel like we're actually now not just continuing growth, but you'll see I think much more growth and momentum as time goes on over the next few weeks.

嗯，我們可以告訴大家的是：環比成長，我們實現了 11% 和 12% 的成長。所以，我們看到了成長。我們在電話會議上分享的其中一件事是，例如，當我們推出 A360 Media 時，它在最初兩週後就推動了需求激增 16%。所以，我們看到的是，我們看到了成長，實際上，我們看到很多個人、經銷商和批發商都在為剛推出的 A360 Media 做好準備。我們與 Annie Murphy 進行了一系列採訪，引起了媒體的廣泛關注。由於這些採訪，未來還會有更多媒體報導。尤其是 7 月 1 日，這家最大的 PBM 正式加入，沒有任何限制。所以我們真的覺得我們現在不僅在持續成長，而且我認為，隨著時間的推移，在接下來的幾周里，我們會看到更大的成長和發展勢頭。

And one more question here is that the third quarter, already a roughly a month and few days. And you've probably seen that the revenue growth increasing. Any colors you can sort of share for this brief month outcomes or any kind of trends you can indicate?

還有一個問題是，第三季已經過了大約一個月又幾天。您可能已經看到收入成長正在加快。能分享一下這個月的業績，或是指出一些趨勢嗎？

I will take that.

我會接受的。

Okay.

好的。

Yes. So I won't give you too much insight, obviously, just we might give you too much guidance going forward in the details. But kind of to reiterate the guidance we gave, obviously, USD30 million to USD35 million, we are still firmly holding on to this for guidance for the year. That means some sequential growth quarter-over-quarter, obviously, as it gets there. Second half of the year, we always knew that was going to be the stronger half of our year, just building on the first half. And things are falling into place very nicely as far as getting this large PBM win and having ACA mandate coming on, both of those we believe are going to be strong headwinds heading into the second half of the year. So I would look to see some good sequential growth, as we've shown already quarter-over-quarter for the first half of the year, continue through the second and we'll fall in between that USD30 million and USD35 million when we get to year-end.

是的。所以我顯然不會透露太多信息，只是我們可能會在細節上給出過多的指導。但我想重申我們給予的指導，顯然是3000萬美元到3500萬美元，我們仍然堅定地堅持這個目標作為全年的指導。這意味著隨著目標的實現，我們的季度環比收入將有所增長。我們一直知道下半年會是我們業績更強勁的半年，只是在上半年的基礎上再接再厲。就PBM的重大勝利和ACA強制令的出台而言，一切都進展順利，我們認為這兩者都將成為下半年的強勁阻力。因此，我期待看到一些良好的環比增長，正如我們上半年季度環比增長所顯示的那樣，這種增長將持續到下半年，到年底，我們的銷售額將介於3000萬美元到3500萬美元之間。

Okay. Maybe squeezing one more question, which you mentioned about the GTN improvement, and would do you see that the reason ACA regulation will be mandated. And would that be any impact you could see change over the second half of this year, or even small changes on the GTN?

好的。或許我再問一個問題，您之前提到過GTN改進的問題，您認為ACA法規強制執行的原因是什麼？這會對今年下半年的GTN產生什麼影響，或者即使只是一些小小的變化？

Yes. I don't know, if you saw the press release we put out, two, was that last week? You can find just about the very recent final push where basically implies that you need to follow ACA. It can be interpreted as immediately. Guidance earlier in the year came out, this is January 1. So there's a bit of question as to (inaudible) were done hearing complaints, you guys need to comply immediately. But that's why we think the timing of it will continue to roll out as the second half of the year goes on. And we will start to see those continued improvement in the copay utilizations program. And ultimately, it will come down to enforcement from the government agencies that have direct oversight over the payers and PBMs. And we think the current administration and the key members on committees are taking this extremely seriously. Coupled with Saundra's continued relentless pursuit of them, I cant say I'd blame them, they're fortunate.

是的。我不知道，如果你看過我們發布的新聞稿，第二份，是上週發布的嗎？你會發現最近的最後衝刺階段，基本上暗示你需要遵守ACA。這可以理解為立即生效。今年稍早發布的指導方針是1月1日。所以，關於（聽不清楚）我們聽完投訴後，你們需要立刻遵守，這有點疑問。但這就是為什麼我們認為，隨著下半年的推進，具體時間會陸續公佈。我們將開始看到共付額利用率項目的持續改善。最終，這將取決於直接監督付款人和藥品福利管理機構（PBM）的政府機構的執法力度。我們認為，現任政府和委員會的主要成員對此非常重視。再加上桑德拉持續不懈地追查，我不能說我會怪他們，他們很幸運。

Well, and the one thing, I-Eh, just to add is that we have heard from a lot of these offices that we have consistently been talking to and reaching out that there is a huge push from certainly the Democratic side to make sure that they're leaning in and stepping up for women. And in the past, although they didn't want to know specifics, all of these offices of Congress people and senators are now asking us for specific examples of women are getting denied. So they can reach out directly and hope that they will be seen as the halo effect of being the ones that are advocating for and standing up for women.

嗯，我想補充一點，我們從許多我們一直在溝通和聯繫的辦公室得知，民主黨方面正在大力推動女性權益的維護。過去，儘管他們不願意了解具體情況，但現在所有這些國會議員和參議員辦公室都要求我們提供女性權益被拒絕的具體例子。這樣，他們就可以直接聯絡我們，希望自己能被視為倡議和維護女性權益的光環效應。

So, what's been refreshing is that we have seen the kind of action should have happened sooner, but we are seeing very serious and deliberate action, i.e., enforcement occurring. And it's optimistic. So at least when women are being denied safe access to abortion, they will get more and more readily get access to contraception.

所以，令人欣慰的是，我們看到了本應更早採取的行動，而且我們看到了非常嚴肅和深思熟慮的行動，也就是執法行動。這是令人樂觀的。所以，至少當女性被剝奪安全墮胎權時，她們將越來越容易取得避孕措施。

Our next question is coming from Annabel Samimy of Stifel.

我們的下一個問題來自 Stifel 的 Annabel Samimy。

Hi, this is Stacy calling in for Annabel. Congrats on a really great quarter. Just 2 questions on our end. Can you give us some metrics around the VitaCare partnership and how that's been helping with prescription fulfillment? And secondly, we're really excited to see the last visit having occurred for the EVOGUARD trial. In light of the latest development with Roe versus Wade being repealed and the increased focus in contraception, more than need to protect it, is there any further thought to how you will treat the STI profile of EVO100 is successful? Is it protective as an addition? Or is it better to remain its own product? I know, the last iteration was that it would be a profile enhancer to contraception.

嗨，我是 Stacy，負責 Annabel 的諮詢。恭喜您本季業績出色。我們這邊只有兩個問題。您能否介紹一下與 VitaCare 合作的一些指標，以及這對處方藥的配給有何幫助？其次，我們很高興看到 EVOGUARD 試驗的最後一次問診已經完成。鑑於羅訴韋德案的最新進展，以及人們對避孕的關注度日益提升，而非僅僅關注避孕的保護作用，您是否進一步考慮過如何看待 EVO100 的性傳染感染效應？它是作為一種保護性補充嗎？還是保留獨立產品比較好？我知道，上次的方案是將其作為避孕措施的增強劑。

Yes, thanks for the question. Jay you want to start and I will jump in for the second one.

是的，謝謝你的提問。 Jay，你想先提問，我來回答第二個問題。

Yes, I'll jump in on VitaCare. So just a little bit of specifics for the quarterly activities, we did do a pilot style rollout with them. And it was extremely successful right from the get go. We are very happy to see that. Obviously, a fairly complex process with the new platform going out. So we wanted to make sure that the pilot program was effective and well received and any kinks were worked out. Subsequent to that we've actually rolled that out fully to the field starting August 1st. And we're already seeing our exits come in from that process. Feedback from the sales reps, doctors' office, all across the board and patient experiences have been extremely favorable. And as a reminder, we were on the term white-glove, but really, this is truly what this experience is. And beyond that, and really integrating patients with a service that really follows them through the entire process, all the way through ensuring that they get their refills on a timely basis, the process itself is it's fully integrated, and it doesn't come in from multiple sources and other multiple vendors. So this is truly a one-stop shopping porthole for us to really fall back on and our patients to use. And we're extremely excited about the initial results. And I think for sure, we'll have definitely much more insight as to how it's been rolled out from the initial launch on August 1st, when we talk for Q3 results.

是的，我來談談VitaCare。我簡單介紹一下季度活動。我們確實與他們合作進行了試點推廣。從一開始，推廣就非常成功，我們對此感到非常滿意。當然，新平台的推出過程相當複雜。因此，我們希望確保試點計畫有效且廣受歡迎，並解決所有問題。之後，我們從8月1日起全面推廣到實際應用。我們已經看到一些客戶從試點計畫中獲得回報。來自銷售代表、醫生辦公室以及所有相關部門的回饋以及患者的體驗都非常積極。提醒一下，我們之前說的是“白手套服務”，但實際上，VitaCare才是真正的體驗。除此之外，我們真正將患者與一項全程追蹤的服務整合在一起，確保他們及時獲得續藥。整個流程本身是完全整合的，無需來自多個來源和多個供應商。所以，這真的是一個一站式購物平台，我們和患者都可以真正依賴它。我們對初步結果感到非常興奮。我相信，當我們討論第三季業績時，我們肯定會對它自8月1日首次發布以來的進展有更深入的了解。

And you know, our Chief Commercial Officer Katherine Atkinson is also with us on the line. Katherine, is there anything you want to add just to fully color the VitaCare situation?

我們的首席商務官凱瑟琳·阿特金森也在線。凱瑟琳，您還有什麼想補充的嗎？這樣才能更全面地介紹一下VitaCare的情況。

Yes, we've seen some great success. So as Jay said, we kind of beta tested it and slowly rolled it out. Of all the prescriptions that came in which were many, we've had 53% already approved and VitaCare continues to work on the remainder. We've rolled it out to the field on August 1st. We had about 20 already go in. And so we're really excited about it. So we'll have far more color coming after this quarter for you. But really great performance up to that point and in our previous programs we were below the 50% and we're not even finished with those first ones that came in. So already off the bat really great numbers.

是的，我們已經取得了一些巨大的成功。正如傑伊所說，我們對其進行了類似beta測試，然後慢慢推廣。在收到的眾多處方中，我們已經批准了53%，VitaCare正在繼續處理剩餘的處方。我們已於8月1日將其推廣到臨床。目前大約有20個處方已經收到。我們對此感到非常興奮。因此，我們將在本季結束後為大家提供更多詳細資訊。但在此之前，我們的表現確實非常出色，在我們先前的專案中，批准率低於50%，甚至還沒有完成第一批處方的批准。所以，我們一開始就取得了非常不錯的成績。

And then I want to address your question regarding EVOGUARD and the STI indication. And I just want to make sure that the question. So can you just frame it again? So you want to know whether or not expanding the label we think will be as advantageous as being a separate product?

然後我想回答您關於 EVOGUARD 和 STI 適應症的問題。我只是想確認一下這個問題。能再提一下嗎？您想知道，我們認為擴大產品標籤是否與單獨生產一樣有利嗎？

Yes, that's correct.

是的，沒錯。

Okay. So one thing. So in the works that we have done around diligence with providers and diligence with payers, we're looking at a couple of different things. And the short answer is expanding the label we have concluded will allow us the same opportunity as if it were a separate NDA. The financial positive is that the sNDA submission will be no cost to us, which is fabulous from a financial standpoint. But even if there was a cost, and we thought it was going to be better for shareholders and women, we certainly would have incurred that cost.

好的。有一件事。在我們圍繞供應商和付款人的盡職調查所做的工作中，我們正在考慮一些不同的事情。簡而言之，擴大標籤範圍，我們認為這將使我們獲得與單獨提交保密協議 (NDA) 相同的機會。財務方面的好處是，提交 sNDA 對我們來說是免費的，從財務角度來看，這非常棒。但即使有成本，而且我們認為這對股東和女性更有利，我們肯定會承擔這筆成本。

Where we are now is when you look at a product that as you may or may not remember those of you on the call, we were able to actually get a publication in a sexual satisfaction journal. When you look at a product that has lubricating properties, and you have a product that will prevent pregnancy with no systemic activity and no hormones and that negatively impacting your ovaries or your ability to get pregnant down the road and prevent from chlamydia and gonorrhea. I will tell you that in all of my years, I've been in women's health my entire life, we used to do these think tanks, where we would say to global leaders, women, all kinds of influencers, let's just talk about nirvana. What would be the most amazing product? And consistently people would say something that you wouldn't suffer from side effects, something that you only use when you needed it, and something that would protect you from getting sexually transmitted infection. Well, let me introduce you to Phexxi. And I mean that and of course, I would say that as the CEO of this company, but I was attracted to this company because of this asset. After spending my whole life looking at me-too products in crowded categories, understanding that when generics come to a market they erode a brand by 50% to 60% but recognizing, most importantly, that women don't have sex every day, and men have had condoms for 150 years. And it is far time that women have a product, where they can have sex on demand, with pleasure without hormonal side effects, the timing could not be better for Phexxi.

我們現在的情況是，當你看到一款產品時，你可能還記得，也可能不記得，我們​​真的能夠在性滿足雜誌上發表文章。當你看到一款具有潤滑特性的產品時，你就擁有了一款可以避孕的產品，它沒有全身活性，也不含激素，不會對你的卵巢或以後的懷孕能力產生負面影響，還能預防衣原體感染和淋病。我可以告訴你，在我這麼多年裡，我一直致力於女性健康事業，我們曾經做過一些智庫，我們會對全球領導人、女性以及各種有影響力的人說，讓我們談談涅槃吧。什麼產品最神奇？人們總是說，有些產品不會有副作用，有些產品只在需要的時候使用，有些產品可以保護你免受性傳染感染。好吧，讓我向你們介紹Phexxi。我是認真的，當然，作為這家公司的首席執行官，我會這麼說，但我被這家公司吸引，正是因為它的這個優勢。我一生都在關注擁擠品類中的“仿製品”，我明白仿製藥進入市場會削弱一個品牌50%到60%的市場份額，但最重要的是，我認識到女性並非每天都有性生活，而男性使用避孕套已有150年曆史。現在是時候讓女性擁有一款產品，讓她們可以隨心所欲地享受性愛，享受愉悅，並且沒有激素副作用，對Phexxi來說，時機再好不過了。

And it is really important to know that how our product works as the vaginal pH modulator. Women intuitively understand it. Doctors intuitively understand it. And so it's simple and it's easy to use, and women feel really good about it. And so the short answer is, is we feel very good that this NDA submission and expanding this label, now, down the road, we may decide with this sort of trifecta of all of these wonderful things that, maybe we want to do a relaunch down the road. But what I would tell you is we feel that the market opportunity is so significant. Because as we said, whether you're on a pill, a patch, or an IUD, you are still at risk. And chlamydia is now so pervasive, 4 million cases.

了解我們的產品作為陰道pH調節劑的工作原理至關重要。女性和醫生都能直觀地理解它。它簡單易用，女性也非常喜歡。簡而言之，我們對此次NDA提交和產品標籤的擴展感到非常滿意。未來，我們或許會結合這三種優勢，決定是否重新推出產品。但我想說的是，我們認為市場機會很大。正如我們所說，無論您服用的是避孕藥、貼片還是子宮內避孕器，您都面臨風險。衣原體感染現在非常普遍，全球已有400萬例。

And final comment I want to say is, after being in women's health my whole life, I have to shamefully admit that I didn't even recognize that chlamydia was one of the top reasons for infertility. And when we start to talk to young women, they're already thinking about their ability to get pregnant when they want to, even though it might be 5 or 6 or 10 years down the road. So if you're protecting yourself from getting pregnant, and you're also worried about your ability to get pregnant, why would you not use a product like Phexxi?

最後我想說的是，我一生致力於女性健康事業，不得不慚愧地承認，我甚至沒有意識到衣原體感染是導致不孕症的主要原因之一。當我們開始與年輕女性交流時，她們已經在考慮自己是否能在想要懷孕時成功受孕，即使那可能是5年、6年甚至10年後的事。所以，如果你正在預防懷孕，同時又擔心自己能否成功受孕，為什麼不使用像Phexxi這樣的產品呢？

Your next question is coming from Ram Selvaraju of H.C. Wainwright.

您的下一個問題來自 H.C. Wainwright 的 Ram Selvaraju。

Just 3 relatively quick ones. First of all, I was wondering if you could comment at all on any emerging trends you're seeing in sort of private pay, or non-reimbursed demand for Phexxi, particularly in the wake of the Supreme Court ruling?

我只問三個相對較短的問題。首先，我想知道您能否評論一下您所看到的 Phexxi 私人支付或非報銷需求的新興趨勢，尤其是在最高法院裁決之後？

Secondly, I was wondering if you have sort of an updated take on returning to the concept that was mooted early in Phexxi's commercial trajectory regarding the population of women who are undergoing cancer treatment of specific categories that would lead them to be ineligible for hormonal forms of birth control?

其次，我想知道您是否對重新審視 Phexxi 商業軌跡早期提出的概念有什麼新的看法，該概念涉及正在接受特定類別癌症治療的女性群體，這些女性將不再適合使用激素避孕方法？

And then lastly, I was wondering if you have updated thoughts on, assuming positive readouts in STI prevention, how you would go about strategically optimizing the value of the drug in that indications, and whether that would involve any kind of business development activity, particularly in the context of the U.S. commercial opportunity?

最後，我想知道您是否有最新的想法，假設性傳染感染預防方面取得積極的成果，您將如何從策略上優化該藥物在該適應症中的價值，以及這是否涉及任何類型的業務發展活動，特別是在美國商業機會的背景下？

I'd like to start backwards, if that's all right. I'm going to start with the last one, meaning the STI opportunities. And the short answer is, definitely. And why I'm saying definitely is that when we expand the label to add on prevention of chlamydia and gonorrhea, we want to provide much broader access to a much wider population. And as you heard from Jay's comments, we are looking at co-promotion and co-marketing partners. We believe that yes, certainly OB-GYNs will be the top prescribers, but we do think that it will expand beyond that frankly.

如果可以的話，我想倒著說。我先從最後一個，也就是性傳染感染的機會說起。簡而言之，肯定有。我之所以說肯定有，是因為當我們擴大產品範圍，增加衣原體和淋病的預防時，我們希望能夠為更廣泛的人群提供更廣泛的覆蓋。正如你從傑伊的評論中聽到的，我們正在尋求共同推廣和共同行銷合作夥伴。我們相信，婦產科醫生肯定會成為主要的處方醫生，但坦白說，我們確實認為，其覆蓋範圍會進一步擴大。

So we are trying to be very strategic and wise about finding a partner that has a footprint. And that is looking for another opportunity to tell an additional story. So we're actively doing that right now. I will tell you that I know, those of you who've been with us for a while, when we talk about business development, we are a little trepidatious because we could get a distribution agreement tomorrow. Yes, we have waited so that we can get the right partners. But for STI, the strategic partnerships are multiple, and our Head of Business Development, full time 100% focused on these partnerships has said that now with Roe versus Wade, what's been fascinating is that the people contacting us is so constant and continuous.

因此，我們正努力以極具策略性和智慧的方式尋找一個有影響力的合作夥伴。這意味著尋找另一個機會來講述新的故事。我們現在正在積極地這樣做。我可以告訴你們，我知道，那些與我們合作了一段時間的人，當我們談到業務發展時，我們有點忐忑不安，因為我們可能明天就拿到分銷協議。是的，我們一直在等待，以便找到合適的合作夥伴。但對於STI來說，策略夥伴關係是多方面的，我們100%專注於這些合作關係的業務發展主管表示，現在有了羅訴韋德案，令人驚訝的是，聯繫我們的人如此持續不斷。

So we are going to look to align with somebody in the U.S. to expand our reach. Still obviously controlling the branding and the messaging, but to see if there's an appropriate partner. And we are continuing our efforts outside of the U.S. to bring in non-dilutive capital.

因此，我們將尋求與美國公司合作，以擴大我們的影響力。我們顯然仍將控製品牌和訊息傳遞，但會考慮是否有合適的合作夥伴。我們將繼續在美國以外地區努力引入非稀釋性資本。

Then your second question.

那你的第二個問題。

NCODA.

NCODA。

Yes, NCODA. So, one of the things that we have tried to see if we can identify, out of the 800,000 women that are cancer patients is, is there a way to see if there are carveouts that we can identify you know who they are. What I will tell you, is from feedback from our sales organization and we also have our Head of Sales, a gentleman who spent his career in oncology by the way. He's the one that helped us align with NCODA, but it's important relationship that we have. What's happening is that as time passes, and even though Roe versus Wade and you would think what does that have to do with cancer patients? What has been extraordinary to see is that regardless of the physician type, but oncologists are continuing to open their eyes up that, one, they certainly don't want their cancer patients to become pregnant during treatment, they don't want estrogen cancers to grow. And the only other product which is a copper IUD has side effects that are oftentimes far too challenging for these patients in a vulnerable state. Phexxi is the obvious choice. So we have been seeing being asked to continuously go and provide products to hospitals to do all kinds of Grand Rounds conversations to continue to elevate and escalate the conversation.

是的，NCODA。所以，我們一直在嘗試辨識80萬名女性癌症患者，看看是否有辦法辨識出符合條件的患者。我想告訴你的是，這來自我們銷售部門的回饋，我們的銷售主管是一位在腫瘤科工作多年的先生。他幫助我們與NCODA達成了一致，但這種關係對我們來說非常重要。隨著時間的推移，即使羅訴韋德案（Roe vs. Wade）——你會想，這與癌症患者有什麼關係？令人驚訝的是，無論醫生類型如何，腫瘤學家們都在不斷意識到，首先，他們當然不希望癌症患者在治療期間懷孕，他們不希望雌激素癌症發展。唯一的另一種產品是銅子宮內避孕器，它的副作用往往對這些脆弱的患者來說太棘手。 Phexxi 是顯而易見的選擇。因此，我們看到他們不斷被要求去醫院提供產品，進行各種大型巡診對話，以不斷提升和升級對話。

So I would say that it is growing, we have not had a way to actually segment that specific population. However, when we're talking to doctors, they are part of bigger practices. And so we are always making sure that our sales organizations, some of whom are cancer survivors themselves, by the way, are making a deliberate effort to go to those hospitals and talk to those clinics in those centers. And we think that's boosting our business.

所以我想說，這個群體正在成長，我們還沒有辦法真正細分這個特定族群。然而，當我們與醫生溝通時，他們往往是大型診所的一部分。因此，我們始終確保我們的銷售團隊（順便說一句，其中一些銷售團隊本身就是癌症倖存者）會特意前往這些醫院，與這些中心的診所進行溝通。我們認為這正在促進我們的業務發展。

The first question, I don't know if our Chief Commercial Officer or Jay File like to want to address it. Jay File, do you?

第一個問題，我不知道我們的首席商務官或傑伊·菲爾是否願意回答這個問題。傑伊·菲爾，你願意回答嗎？

Yes, no, we do. Okay, perfect. Go ahead, Katherine.

是的，不，我們有。好的，太好了。說吧，凱瑟琳。

Well, I think, one thing that we could mention, and I think this could actually help is, in spite of whether some of these small private payers are moving this way, we are being, again, proactive in doing something that helps women. So we have a cash card program that we're going to be rolling out in the next few weeks. So even if payers aren't moving to increase access immediately, we're going to do what we can.

嗯，我想，有一件事我們可以提一下，而且我認為這實際上會有所幫助，那就是無論一些小型私人保險公司是否正在採取這種行動，我們都在積極主動地做一些幫助女性的事情。所以我們有一個現金卡項目，將在未來幾週內推出。所以，即使保險公司沒有立即採取行動來增加女性的就醫管道，我們也會盡力而為。

Ram, does that address your questions?

Ram，這回答了你的問題嗎？

Yes, that was very helpful. But I think just to clarify, I was also asking about, those folks who are prepared to pay out of pocket, if you're seeing sort of an increased level of interest in doing that since the Supreme Court ruling or not?

是的，這很有幫助。但我想澄清一下，我還想問一下，那些願意自掏腰包的人，自從最高法院裁決以來，你是否看到他們對此的興趣增加？

Yes. I think to expand on that, we are always about 2 weeks behind on script data. And to get into that level, obviously, it's just starting to come in. I will say that traditionally, the self-pay category as we trended is not a very significant number of our sales. It is there, which is why we also did implement that cash card program that Katherine is referring to. And that is just being, we had recently rolled out, actually it was kind of great timing on our part, because we rolled that out in advance of Roe v. Wade decision coming out. But I think we'll get better clarity to see if that is truly an issue to that degree. But I think, ultimately speaking, anecdotally, I think the majority of the Phexxi prescriptions that are coming through, you're still going to see them either one come through. Some sort of payer assistance program, right, they've got their own insurance and/or a governmental support program that they'll have coverage through state or federal means. So a true uptake on someone who doesn't have either and is paying straight out of pocket, they'll definitely be there. We put in steps at a time to potentially assist them. But I think we'll truly see, we'll follow up on that in Q3, I think we'll have much better visibility on that to see if truly is something that is trending on and something that we've timed right with our cash rebate card.

是的。我想進一步說明一下，我們的處方數據總是落後約兩週。而要達到這個水平，顯然，它才剛開始出現。我想說的是，傳統上，我們趨勢中的自付費用類別在我們的銷售額中所佔比例並不大。它確實存在，這就是為什麼我們也實施了凱瑟琳提到的現金卡計劃。我們最近才推出這個計劃，實際上，對我們來說時機非常好，因為我們在羅訴韋德案判決公佈之前就推出了它。但我認為我們會更清楚地了解這是否真的是一個如此嚴重的問題。但我認為，最終來說​​，從傳聞來看，我認為大多數Phexxi的處方，你仍然會看到它們通過某種付款人援助計劃獲得報銷，對，他們有自己的保險和/或政府支持計劃，可以通過州或聯邦政府的渠道獲得報銷。所以，對於那些沒有信用卡或信用卡、直接自掏腰包的人來說，他們肯定會真正接受這種服務。我們會逐步採取措施，盡可能地幫助他們。但我認為我們會在第三季繼續跟進，屆時我們將對這方面有更清晰的了解，看看這是否真的是一種趨勢，以及我們推出現金回饋卡的時機是否合適。

That's all the time that we have for today. I'll turn the call back over to Saundra Pelletier for closing remarks.

今天的時間就到這裡。接下來，請桑德拉‧佩爾蒂埃致閉幕詞。

Thank you. We continue to grow Phexxi net product sales quarter-over-quarter in the multibillion dollar U.S. contraceptive market. We are on track to meet our guidance for 2022. With the Supreme Court ruling on Roe versus Wade in June, women are increasingly motivated to protect themselves from unintended pregnancies. The recent guidelines from the U.S. government on contraceptive access should catalyze access to Phexxi at zero cost to women with no barriers to access. Additionally, there is significant upside potential from our late stage program developing Phexxi for the prevention of chlamydia and gonorrhea in women.

謝謝。在價值數十億美元的美國避孕藥具市場，Phexxi 的淨產品銷售額持續較上季成長。我們預計將實現 2022 年的預期目標。隨著最高法院今年 6 月就羅訴韋德案作出裁決，女性越來越積極地保護自己，避免意外懷孕。美國政府最近發布的避孕藥具獲取指南，應該會促進女性以零成本獲得 Phexxi，並且沒有任何獲取障礙。此外，我們目前正在開發的用於預防女性衣原體感染和淋病的 Phexxi 計畫也具有巨大的成長潛力。

In closing, I want to reiterate that we remain focused on execution of our business strategies to deliver long-term shareholder value. The time for Phexxi is now. The need is greater than ever, both for hormone free contraception, and for prevention of STIs. We are excited about our future. And we are very, very happy to have you on this journey with us. As you look to organizations that are delivering innovation, but continuing to execute, when I started this call, I said that since April, we have been able to share 16 value drivers to deliver on our business and deliver shareholder return, 16. Those were not announcements that were fluff. There wasn't a whole lot of gray in there. These are very deliberate, intentional milestones that we continue to deliver on to prove that this product deserves to not only grow, but the attributes of this in a time that we're in today, it makes it such an obvious investment. And the value inflection that's forthcoming in October when we share our readout for our STI study is very significant.

最後，我想重申，我們始終專注於執行業務策略，以實現長期股東價值。 Phexxi 的時代已經來臨。無論是對無荷爾蒙避孕藥，還是預防性傳染感染，需求都比以往任何時候都更加迫切。我們對未來充滿期待，也非常高興您能與我們攜手同行。正如您所看到的，那些不斷創新並持續執行的組織，我在開始這次電話會議時就說過，自4月份以來，我們已經分享了16個價值驅動因素，以推動我們的業務發展並實現股東回報。這些並非空洞的聲明，其中沒有太多空洞的之處。這些都是經過深思熟慮、有針對性的里程碑，我們將繼續努力，以證明這款產品不僅值得成長，而且在當今時代，它的特質使其成為一項顯而易見的投資。 10月份，當我們分享性傳染感染研究結果時，即將出現的價值轉折點意義重大。

So I want to thank all of you that have been with us for a while and I'd love to again, welcome the people that are new, and I really want to thank you for your ongoing support. Have a great rest of your day.

所以，我要感謝所有與我們共事一段時間的各位，也歡迎新成員的到來，也衷心感謝大家一直以來的支持。祝大家今天過得愉快。

Ladies and gentlemen, thank you for joining us. You may now disconnect.

女士們，先生們，感謝您的收看。現在您可以斷開連線了。