雷傑納榮製藥 (REGN) 2021 Q1 法說會逐字稿

Welcome to the Regeneron Pharmaceuticals First Quarter 2021 Earnings Conference Call. My name is Mary, and I will be your operator for today's call.

歡迎參加再生元製藥公司2021財年第一季財報電話會議。我是瑪麗，將擔任本次電話會議的接線生。

(Operator Instructions)

（操作說明）

Please note that this conference is being recorded. I will now turn the call over to Justin Holko, Vice President, Investor Relations. You may begin.

請注意，本次會議正在錄音。現在我將把電話交給投資者關係副總裁賈斯汀·霍爾科先生。您可以開始了。

Thank you, Mary. Good morning, good afternoon, and good evening to everyone listening around the globe. Thank you for your interest in Regeneron Pharmaceuticals, and welcome to the First Quarter 2021 conference call. An archive of this webcast will be available on our website. Joining me on the call today are Dr. Leonard Schleifer, Founder, President and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President and Chief Scientific Officer; Marion McCourt, Executive Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

謝謝瑪麗。各位全球聽眾，早安、下午好、晚上好。感謝您對再生元製藥的關注，歡迎參加2021年第一季業績電話會議。本次網路直播的存檔將在我們的網站上提供。今天與我一同參加電話會議的有：創始人、總裁兼首席執行官倫納德·施萊弗博士；聯合創始人、總裁兼首席科學官喬治·揚科波洛斯博士；執行副總裁兼商務主管瑪麗昂·麥考特；以及執行副總裁兼首席財務官鮑勃·蘭德里。在我們發言結束後，我們將進入問答環節。

I would also like to remind you that remarks made on today's call include forward-looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, intellectual property, pending litigation and other proceedings and competition.

我還要提醒各位，今天電話會議的發言包含Regeneron的前瞻性聲明。這些陳述可能包括但不限於與Regeneron及其產品和業務、財務預測和指導、研發項目及相關預期里程碑、合作、財務、監管事宜、支付方覆蓋範圍和報銷問題、知識產權、未決訴訟和其他程序以及競爭相關的陳述。

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in that statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-Q for the period ended March 31, 2021, which we filed with the SEC earlier today.

每項前瞻性聲明均受風險和不確定性因素的影響，這些因素可能導致實際結果和事件與聲明中預測的結果和事件有重大差異。有關這些風險和其他重大風險的更完整描述，請參閱Regeneron向美國證券交易委員會提交的文件，包括我們今天早些時候向美國證券交易委員會提交的截至2021年3月31日止季度的10-Q表格。

Regeneron does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. In addition, please note that the GAAP and non-GAAP measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release, which can be accessed on our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer.

再生元公司不承擔任何更新前瞻性聲明的義務，無論是因為新資訊、未來事件或其他原因。此外，請注意，我們將在今天的電話會議中討論GAAP和非GAAP財務指標。有關我們使用非GAAP財務指標以及這些指標與GAAP的調節表的信息，請參閱我們網站上發布的財務業績新聞稿。電話會議結束後，Bob Landry和投資者關係團隊將回答其他問題。接下來，我將把電話會議交給我們的總裁兼執行長Len Schleifer博士。

Thank you, Justin, and thank you to everyone joining today's call. We're off to a strong start in 2021, again delivering double-digit growth on the top and bottom lines. I'm immensely proud of all that Regeneron continues to accomplish in the fight against COVID and for patients suffering from a variety of diseases. Our performance highlights the continued evolution, diversification and durability of our business as we enter a new phase of growth and new product launches.

謝謝賈斯汀，也謝謝今天所有參加電話會議的各位。 2021年我們開局強勁，營收和利潤再次達到兩位數成長。我為Regeneron在對抗新冠疫情以及造福各種疾病患者方面所取得的成就感到無比自豪。我們的業績凸顯了公司業務的持續發展、多元化和穩健性，也預示著我們將進入新的成長階段，並推出更多新產品。

Strong performance begins with differentiated products that deliver real value for patients. Starting with EYLEA. Global net sales were nearly $2.2 billion, growing 17% compared to the prior year. In the U.S., sales grew 15%, reflecting continued positive momentum and execution on our strategy. We are confident in the EYLEA business and expect it will remain a key growth driver for Regeneron for years to come.

強勁的業績源自於能為患者帶來真正價值的差異化產品。 EYLEA 就是個很好的例子。其全球淨銷售額接近 22 億美元，較上年成長 17%。在美國，銷售額成長 15%，這反映了我們策略的持續良好動能和有效執行。我們對 EYLEA 的業務充滿信心，並預計它將在未來幾年繼續成為 Regeneron 的關鍵成長動力。

We are also very pleased with the performance of Dupixent in the quarter, where global sales approached $1.3 billion and grew 48%. The brand is now annualizing sales in excess of $5 billion. Yet we believe there remains considerable room for further market growth and penetration in atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis.

我們對Dupixent在本季的表現也非常滿意，其全球銷售額接近13億美元，成長了48%。該品牌目前的年銷售額已超過50億美元。然而，我們認為在異位性皮膚炎、氣喘和伴隨鼻息肉的慢性鼻竇炎領域，市場仍有相當大的成長和滲透空間。

With several additional potential indications in Phase III trials, such as eosinophilic esophagitis, and COPD, we are still in the early days of realizing the full potential of this unique pipeline in the product. In oncology, we are making steady progress with Libtayo as global net sales reached $101 million and grew 35% from the prior year.

由於該產品在第三期臨床試驗中還涉及嗜酸性粒細胞性食道炎和慢性阻塞性肺病等多個潛在適應症，我們仍處於充分發揮其獨特產品線潛力的早期階段。在腫瘤領域，Libtayo 的研發進展穩步推進，全球淨銷售額達到 1.01 億美元，較前一年成長 35%。

Importantly, in February, we secured 2 new FDA approvals for Libtayo in basal cell carcinoma and in non-small cell lung cancer, which we anticipate will help fuel a new period of growth for this product that is a foundation to our oncology strategy. While still in very early days with these new launches, we are seeing encouraging signals on a variety of leading indicators, from thought leaders, prescribers, payers and patients.

值得一提的是，今年2月，我們獲得了FDA對Libtayo的兩項新批准，分別用於治療基底細胞癌和非小細胞肺癌。我們預計這將有助於推動產品進入新一輪增長期，而Libtayo正是我們腫瘤策略的基石。儘管這些新藥上市仍處於初期階段，但我們已經從包括行業領袖、處方醫生、支付方和患者在內的多個關鍵指標中看到了令人鼓舞的信號。

And last but not least, we were able to deliver significant Phase III outcome data for our REGEN-COV program, aimed at treating and preventing COVID-19 infections. As George will outline momentarily, we have now shown that our antibody cocktail dramatically reduces hospitalizations or death in non-hospitalized COVID infected patients and reduces symptomatic infections when given as a preventative measure.

最後，我們發表了REGEN-COV計畫的重要III期臨床試驗結果數據，該計畫旨在治療和預防COVID-19感染。正如George稍後將詳細介紹的，我們已證實，我們的抗體雞尾酒療法能夠顯著降低非住院COVID-19感染患者的住院率和死亡率，並且在作為預防措施使用時，還能減少有症狀的感染。

We are seeking to update our emergency use authorization to reflect these new data and uses as well as the lower 1.2 gram dose. Thinking longer-term for REGEN-COV, we see an ongoing global need for treatment and chronic prevention of COVID disease. Despite high rates of vaccination, it's estimated that tens of millions will remain unvaccinated in the U.S. alone.

我們正在尋求更新緊急使用授權，以反映這些新數據和用途，以及更低的1.2克劑量。從長遠來看，我們認為REGEN-COV在全球範圍內對治療和預防COVID-19疾病的需求持續存在。儘管疫苗接種率很高，但據估計，光在美國就有數千萬人未接種疫苗。

And of those who are vaccinated, significant numbers will not mount a protective response, such as those who are immunocompromised or immunosuppressed. It is important to recognize Regeneron's, and the bio-pharmaceutical industry at large, response and ongoing actions in combating COVID-19. Breakthrough vaccines and treatments are having a profound impact on the health and well-being of people in the United States and around the globe.

接種疫苗的人群中，相當一部分人無法產生有效的保護性免疫反應，例如免疫功能低下或免疫抑制者。我們必須肯定再生元公司以及整個生物製藥產業在對抗新冠疫情方面所做出的回應和持續努力。突破性的疫苗和療法正在對美國和全球人民的健康和福祉產生深遠的影響。

In addition, safe and effective vaccines and treatments are enabling economic recovery. All of these critical benefits come as a result of the investments that have been made in technologies over decades by both the public and private sectors. These profound effects highlight the importance of a healthy bio-pharmaceutical industry that fully incentivizes innovation so that new solutions to emerging disease can rapidly be invented and deployed.

此外，安全有效的疫苗和療法正在推動經濟復甦。所有這些關鍵效益都源於公共和私營部門數十年來對相關技術的持續投資。這些深遠的影響凸顯了健全的生物製藥產業的重要性，該產業應充分激勵創新，以便能夠迅速研發並應用針對新興疾病的新解決方案。

We've also learned that these extraordinary approaches to preventing and treating COVID-19 can work only with people who actually receive the vaccines or drugs. For example, an internal health economic analysis projected that tens of thousands of lives in the United States could be saved over the next several months if REGEN-COV were fully deployed and given to all appropriate patients who are diagnosed with COVID-19 and at high-risk for hospitalization or death.

我們也了解到，這些預防和治療新冠肺炎的特殊方法只有在真正接種疫苗或服用藥物的人群中才能發揮作用。例如，一項內部衛生經濟學分析預測，如果REGEN-COV疫苗能夠全面部署並用於所有確診新冠肺炎且有住院或死亡高風險的患者，那麼未來幾個月內，美國將有數萬人的生命得以挽救。

And this is the case where cost to patients is not an issue as the government is providing the drug free of charge. Clearly, we have to better understand why a drug that has demonstrated overwhelming evidence for its ability to reduce hospitalizations or death by 70%, is in ample supply, has been endorsed by the NIH, has been authorized under an EUA by the FDA and is free of charge to patients, is not being taken full advantage of.

而且，在這種情況下，由於政府免費提供藥物，患者無需承擔費用。顯然，我們必須更好地理解，為什麼一種已有大量證據表明能夠將住院率或死亡率降低70%、供應充足、獲得美國國立衛生研究院 (NIH) 認可、獲得美國食品藥品監督管理局 (FDA) 緊急使用授權 (EUA) 且患者免費使用的藥物，沒有得到充分利用。

Regeneron is committed to collaborating with our health care partners to take optimal advantage of the REGEN-COV cocktail potential health benefits. Overall, we are pleased in all that Regeneron has accomplished in the first 3 months of the year and look forward to continued momentum and progress across our diverse pipeline in the months to come. Now I will turn the call over to George.

再生元致力於與我們的醫療保健合作夥伴攜手合作，充分發揮 REGEN-COV 雞尾酒療法的潛在健康益處。總體而言，我們對再生元在今年前三個月取得的成就感到滿意，並期待在未來幾個月裡，我們多元化的產品線能夠繼續保持成長勢頭並取得進展。現在，我將把電話交給喬治。

Thank you, Len. With COVID-19 still in the headlines, I will start with our monoclonal antibiotic treatment, REGEN-COV cocktail. We recently reported data from a large Phase III outcomes trial in the outpatient setting, confirming that REGEN-COV reduced the risk of hospitalization or death by 70% with both the 2.4 gram and the lower 1.2 gram doses.

謝謝Len。鑑於新冠肺炎疫情仍是新聞熱點，我先來談談我們的單株抗生素療法—REGEN-COV雞尾酒療法。我們近期發表了一項大型III期門診臨床試驗的數據，證實無論使用2.4克劑量或較低的1.2克劑量，REGEN-COV都能將住院或死亡風險降低70%。

We are pleased that based on these data, the NIH guidelines were updated in early April to include a strong recommendation for monoclonal antibody combinations to treat out patients with mild or moderate COVID-19, as defined by the EUA criteria. We also recently reported data from a large 2-part Phase III trial of REGEN-COV, with Part A in the preventative setting and Part B in recently infected patients. In Part A of the trial, REGEN-COV prevented 81% of symptomatic COVID-19 infections, with 93% prevention after the first week.

我們很高興地看到，基於這些數據，美國國立衛生研究院 (NIH) 於 4 月初更新了指南，強烈建議使用單株抗體聯合療法治療符合緊急使用授權 (EUA) 標準的輕度或中度 COVID-19 患者。此外，我們近期也發表了 REGEN-COV 一項大型 III 期臨床試驗的數據，該試驗分為兩部分，A 部分用於預防，B 部分用於近期感染患者。在 A 部分試驗中，REGEN-COV 預防了 81% 的有症狀 COVID-19 感染，第一週後的預防率達到 93%。

A supportive study in healthy volunteers that explored chronic dosing showed a similar 92% prevention of infection. Notably, these results were achieved with a convenient and subcutaneous formulation. Chronic prevention with our antibody cocktail may prove to be critical in the ongoing battle against this virus. Despite high rates of vaccination, it is estimated that tens of millions of Americans will remain unvaccinated, thus at risk for future infection. In addition, it is estimated that millions of Americans will not mount an adequate response to vaccines.

一項針對健康志願者的支持性研究探討了長期給藥方案，結果顯示感染預防率同樣高達92%。值得注意的是，這些結果是透過一種便捷的皮下注射製劑來實現的。使用我們的抗體雞尾酒進行長期預防可能對持續對抗這種病毒至關重要。儘管疫苗接種率很高，但據估計仍有數千萬美國人未接種疫苗，因此面臨未來感染的風險。此外，據估計還有數百萬美國人對疫苗無法產生足夠的免疫反應。

For example, immunocompromised individuals or organ transplant patients, or who suffer from certain cancers such as lymphomas, leukemias and myelomas or an immunosuppressant therapies for their autoimmune diseases might all be candidates for chronic prevention using our antibody cocktail.

例如，免疫功能低下者、器官移植患者、患有淋巴瘤、白血病和骨髓瘤等某些癌症的患者，或正在接受自體免疫疾病免疫抑制治療的患者，都可能成為使用我們的抗體混合物進行長期預防的候選人。

Part B of this Phase III trial in recently infected patients showed that the subcutaneous administration of the 1.2 gram dose was also effective in reducing symptomatic disease and shortening disease duration. We are anticipating the existing EUA will be amended based upon the above data to include the 1.2 gram REGEN-COV dose to allow the cocktail to be used for prevention and to include the subcutaneous formulation for ease of use.

這項針對近期感染患者的III期臨床試驗B部分顯示，皮下注射1.2克劑量也能有效減輕症狀並縮短病程。我們預計，根據上述數據，現有的緊急使用授權（EUA）將會進行修訂，將1.2克劑量的REGEN-COV納入其中，使該混合製劑可用於預防，並允許使用皮下注射劑型，以方便患者使用。

We believe the current data is supportive of a potential formal BLA approvals by the FDA. I would like to remind everyone that outside of the United States, where some countries have an even more ongoing dire need for COVID-19 medicines, our partner, Roche, is rapidly expanding availability of the treatment.

我們認為目前的數據支持FDA正式批准該藥物的生物製品許可申請（BLA）。我想提醒大家，在美國以外，有些國家對新冠肺炎藥物的需求更為迫切，我們的伴侶羅氏正在迅速擴大該療法的供應。

Last year, we anticipated that certain variants were likely to emerge and therefore designed our current cocktail to be active against these variants. Experimental evidence suggests that our cocktail is indeed active against all current variants of concern. Similarly, in the anticipation of future variants that may emerge, we are bringing additional antibodies to the clinic shortly.

去年，我們預見到某些變異株可能會出現，因此設計了目前針對這些變異株的聯合療法。實驗證據表明，我們的聯合療法確實對所有目前關注的變異株都有效。同樣，為了因應未來可能出現的變異株，我們即將推出更多抗體用於臨床試驗。

Moving on to EYLEA. A recent NIH sponsored Protocol W trial in non-proliferative diabetic retinopathy patients confirm results of our own PANORAMA study. After 2 years, EYLEA reduced vision-threatening complications by 6% to 8% compared to a group of patients who delayed treatment.

接下來談談EYLEA。美國國立衛生研究院（NIH）近期資助的一項針對非增殖性糖尿病視網膜病變患者的W方案試驗證實了我們自身PANORAMA研究的結果。兩年後，與延遲治療的患者組相比，EYLEA使威脅視力的併發症減少了6%至8%。

A recent Regeneron follow-up analysis in the similar designed PANORAMA trial found that delaying treatment resulted in 3x as many patients suffering prolonged vision loss compared to those receiving preventative EYLEA treatment during a 2-year period. A similar analysis has not yet been conducted for Protocol W. Protocol W is the second study in diabetic retinopathy showing benefit of a less frequent EYLEA dosing regimen.

Regeneron公司近期對設計相似的PANORAMA試驗進行的一項後續分析發現，與接受EYLEA預防性治療的患者相比，延遲治療導致2年內出現持續性視力喪失的患者人數增加了3倍。目前尚未對W方案進行類似分析。 W方案是第二項在糖尿病視網膜病變領域證實減少EYLEA給藥頻率有益的研究。

And we are planning on filing to expand the U.S. EYLEA label by adding the 16-week dosing interval for appropriate patients in the second half of this year. By year-end, we are expecting first data from the Phase II study testing a high dose of EYLEA in wet AMD. From these data, we can expect early reads on anatomic differences and drying between the higher and lower dose at 8, and potentially, 12-week intervals.

我們計劃在今年下半年向美國監管機構提交申請，擴大EYLEA的適應症範圍，為合適的患者增加16週的給藥間隔。到年底，我們預計將獲得EYLEA高劑量治療濕性AMD的II期臨床試驗的首批數據。根據這些數據，我們可以初步了解高劑量組和低劑量組在8週（甚至可能12週）給藥間隔下的解剖結構差異和乾燥情況。

While the study data will not be definitive on durability measures, the Phase II study will help provide insights on what we might expect from the Phase III studies, which are testing dosing intervals out to 12 and 16 weeks. Importantly, in the 106 patients dosed in the open-label Phase II study so far, we haven't seen any concerning safety signals. The Phase III studies in wet AMD and in DME are expected to be fully enrolled by the second half of this year.

雖然該研究數據無法對療效持久性做出最終判斷，但這項 II 期研究將有助於我們了解 III 期研究的預期結果，III 期研究正在測試長達 12 週和 16 週的給藥間隔。值得注意的是，在目前已接受給藥的 106 名患者中，我們尚未發現任何令人擔憂的安全訊號。針對濕性 AMD 和 DME 的 III 期研究預計將於今年下半年完成全部受試者招募。

Moving on to Dupixent in our immunology and inflammation portfolio. Dozens of recent presentations at key dermatology meetings highlight the ever-increasing scope of Dupixent efficacy and safety in patients as young as 6 years old, including rapid itch relief, sustained improvement in disease severity and overall quality of life.

接下來談談我們免疫和發炎產品組合中的Dupixent。近期在數十場重要的皮膚科會議上，Dupixent的療效和安全性不斷提升，其適用人群包括6歲及以上的患者，療效顯著，包括快速緩解瘙癢、持續改善疾病嚴重程度和整體生活品質。

Importantly, Dupixent is not immunosuppressive, nor have -- we have not seen an increased risk of serious infections with Dupixent. This mounting wall of data and physician experience fortifies our belief that Dupixent will remain the preferred choice for multiple Type 2 inflammatory diseases. In the first quarter, we submitted data to support the use of Dupixent in children 6 to 11 years old with moderate to severe asthma.

重要的是，Dupixent 不具有免疫抑製作用，而且我們也沒有發現使用 Dupixent 會增加嚴重感染的風險。越來越多的數據和醫生的經驗鞏固了我們的信念，即 Dupixent 仍將是多種 2 型發炎性疾病的首選治療方案。第一季度，我們提交了支持 Dupixent 用於治療 6 至 11 歲中重度氣喘兒童的數據。

The BLA supplement has an FDA action date of October 21 of this year. A similar application has been submitted in the EU. We previously announced positive data in the part A part of our Phase III trial in eosinophilic esophagitis and part B of this trial is fully enrolled. In addition, 2 Phase III trials of Dupixent in type 2 COPD are actively enrolling patients. Our complementary program with our anti IL-33 antibody, itepekimab, in a different group of COPD patients former smokers is progressing with both Phase III trials now enrolling.

生物製品許可申請（BLA）補充申請的FDA核准日期為今年10月21日。我們已向歐盟提交了類似的申請。先前，我們公佈了嗜酸性食道炎III期臨床試驗A部分的積極數據，該試驗B部分已完成全部受試者招募。此外，Dupixent治療第二型慢性阻塞性肺病（COPD）的兩項III期臨床試驗正在積極招募患者。我們針對另一類COPD患者（既往吸菸者）的抗IL-33抗體itepekimab的補充計畫也在推進中，兩項III期臨床試驗均已開始招募患者。

We believe that this broad COPD program, including Dupixent and itepekimab, may provide real benefit for many patients. Turning now to our novel approach to treat allergy by using cocktails of monoclonal antibodies to directly bind and inactivate the allergen. These cocktails are designed to act immediately and to be long-lasting and to replace currently cumbersome approaches to allergy desensitization that involve years of multiple weekly injections.

我們相信，包括度普利單抗和伊替皮單抗在內的這項廣泛的慢性阻塞性肺病（COPD）治療方案，有望為許多患者帶來真正的益處。接下來，我們將介紹我們治療過敏症的新方法：使用單株抗體混合物直接結合併滅活過敏原。這些混合物旨在快速起效且療效持久，取代目前繁瑣的過敏脫敏療法——後者需要數年時間每週多次注射。

The anti -- [Beth Levine] antibody cocktail binds and inactivates the Beth Levine allergen that causes birch pollen allergy, one of the most common seasonal allergies that occur in the spring. Following Phase II data showing immediate and long-lasting effects against allergen challenge, we initiated a Phase III study and results are expected later this year. Assuming success in the current study, we're planning to conduct a second Phase III study during an upcoming birch pollen season.

這種抗[貝絲·萊文]抗體混合物能夠結合併滅活引起樺樹花粉過敏的貝絲·萊文過敏原，樺樹花粉過敏是春季最常見的季節性過敏之一。在第二期臨床試驗數據顯示該混合物對過敏原激發具有即時和持久的療效後，我們啟動了三期臨床試驗，預計今年稍後公佈結果。如果本研究成功，我們計劃在即將到來的樺樹花粉季節進行第二項三期臨床試驗。

Regarding our similarly designed Fel d 1 antibody cocktail for cat allergy, Phase II data were presented earlier this year at a AAAAI meeting showing that single administration of the antibody cocktail prevented early asthma reactions in allergic patients and prevented lung function decline upon cat allergen exposure when compared to placebo.

關於我們類似設計的用於治療貓過敏的 Fel d 1 抗體混合物，今年早些時候在 AAAAI 會議上公佈了 II 期數據，結果顯示，與安慰劑相比，單次注射該抗體混合物可預防過敏患者的早期哮喘反應，並防止接觸貓過敏原後肺功能下降。

Following this positive data update, the first Phase III trial in cat allergies planned for later this year. We're enthusiastic about these novel additions to our inflammation and immunology portfolio that could represent new groundbreaking ways to treat allergic diseases. Moving on to Libtayo and our oncology portfolio. In the first quarter, Libtayo was approved for the first-line treatment of certain patients with non-small cell lung cancer and for advanced basal cell carcinoma, each being crucial early milestones for our oncology strategy.

繼此次積極的數據更新之後，我們計劃於今年稍後啟動首個針對貓過敏的III期臨床試驗。我們對這些發炎和免疫學產品組合中的新成員感到非常興奮，它們有望為過敏性疾病的治療帶來突破性的新方法。接下來談談Libtayo及其在腫瘤領域的應用。第一季度，Libtayo核准用於部分非小細胞肺癌患者的第一線治療以及晚期基底細胞癌的治療，這兩項獲準都是我們腫瘤策略中至關重要的早期里程碑。

In addition, a Phase III study, of Libtayo in second-line cervical cancer was stopped early for an overwhelmingly positive overall survival benefit, a first for any systemic treatment in these patients. These data will be shared at an upcoming medical meeting and regulatory submissions are planned for this year.

此外，一項針對二線子宮頸癌患者的Libtayo III期臨床試驗因總生存期顯著獲益而提前終止，這是此類患者接受任何全身治療以來首次取得如此顯著的收益。相關數據將在即將召開的醫學會議上公佈，並計劃於今年提交監管申報。

Additionally, we look forward to sharing an expanded data set of [cemiplimab], our anti-lag-3 program at the upcoming ASCO meeting. Cemiplimab is being studied in combination with Libtayo in first line melanoma. In the second half of this year, we anticipate results of an interim analysis for overall survival in our Phase III Libtayo lung cancer chemotherapy combination study.

此外，我們期待在即將召開的ASCO會議上分享我們抗LAG-3計畫[cemiplimab]的擴展資料集。 Cemiplimab目前正在與Libtayo合併用於第一線黑色素瘤治療的研究。今年下半年，我們預計將公佈Libtayo肺癌化療合併用藥III期研究中總存活期的中期分析結果。

Moving on to our bispecific portfolio. In multiple myeloma, our BCMAxCD3 bispecific, for which we now hold exclusive development rights is continuing through dose escalation and dose expansion. We expect to initiate new combination studies in earlier lines of multiple myeloma later this year. Regeneron is uniquely positioned to mix and match multiple modalities and targets with the hope of increasing deep responses we are already observing with the CD3 bispecific.

接下來談談我們的雙特異性抗體產品組合。在多發性骨髓瘤領域，我們目前擁有獨家開發權的BCMAxCD3雙特異性抗體正在進行劑量遞增和劑量擴展研究。我們預計今年稍後啟動針對多發性骨髓瘤早期階段的新聯合療法研究。再生元公司擁有獨特的優勢，能夠將多種療法和標靶進行組合，以期進一步提高我們目前已在使用CD3雙特異性抗體時觀察到的深度緩解率。

We are planning to add a co-stim bispecific to our arsenal of clinical stage multiple myeloma investigational therapies early next year. Moving to lymphoma. Responses to our CD20xCD3 bispecific odronextamab demonstrates increasing durability Regarding the partial clinical hold on this program, we have agreed to a path forward with the FDA, submitted the updated protocol and are expected to hear back on lifting the partial hold in the very near term.

我們計劃在明年初將一種共刺激雙特異性抗體加入我們處於臨床階段的多發性骨髓瘤研究性療法庫中。接下來，我們將轉向淋巴瘤領域。我們的CD20xCD3雙特異性抗體odronextamab的療效顯示持續性增強。關於該計畫的部分臨床試驗暫停，我們已與FDA達成一致，提交了更新後的方案，預計近期將收到關於解除部分暫停的回應。

Enrollment of the follicular lymphoma and diffuse large B-cell lymphoma cohorts of the Phase II pivotal INTENT trial should resume quickly thereafter. Additionally, testing of the odronextamab subcutaneous formulation will start later this year and the paired co-stim bispecific combination is also on track to initiate within the next 12 months.

Ⅱ期關鍵性INTENT試驗中濾泡性淋巴瘤和瀰漫性大B細胞淋巴瘤隊列的入組工作應在此之後迅速恢復。此外，odronextamab皮下製劑的試驗將於今年稍後啟動，而雙特異性抗體聯合刺激療法的試驗也預計在未來12個月內啟動。

Regarding our solid tumor efforts with our bispecific, ovarian cancer is the first indication for which we are already clinically testing 2 different types of bispecifics for the appropriate tumor target, MUC16. Dose escalation of our MUC16xCD3 bispecific is ongoing, and we are hoping to share initial data next year, if not sooner.

關於我們利用雙特異性抗體治療實體瘤的研究，卵巢癌是我們已經開始進行臨床試驗的首個適應症，我們正在針對合適的腫瘤標靶MUC16測試兩種不同類型的雙特異性抗體。 MUC16xCD3雙特異性抗體的劑量遞增試驗正在進行中，我們希望明年，甚至更早，能夠分享初步數據。

In the MUC16xCD28 co-stim study, patients are dosed in combination with Libtayo, and dose escalation is ongoing. Combination of the CD3 and CD28 co-stim bispecifics targeting MUC16 will start later this year, and it has the potential to be a game-changing strategy for treatment of these solid tumors. In prostate cancer, PSMAxCD28 is in dose escalation studies with Libtayo, and we hope to share initial data next year or sooner. As seen in our other programs, we are planning on introducing a potentially complementary CD3 bispecific to the clinic later this year, rounding out a powerful and unique tool kit for prostate cancer, currently considered unresponsive to immunotherapy.

在MUC16xCD28共刺激研究中，患者接受利妥昔單抗（Libtayo）合併治療，劑量遞增試驗正在進行中。針對MUC16的CD3和CD28共刺激雙特異性抗體的聯合治療將於今年稍後啟動，並有望成為治療這些實體瘤的突破性策略。在攝護腺癌領域，PSMAxCD28正與利妥昔單抗共同進行劑量遞增研究，我們希望明年或更早分享初步數據。正如我們在其他項目中所見，我們計劃在今年稍後將一種潛在的互補型CD3雙特異性抗體引入臨床，從而完善一套強大而獨特的前列腺癌治療工具包，目前前列腺癌被認為對免疫療法無反應。

Regarding our early efforts in lung cancer and other solid tumors, our EGFRxCD28 co-stim bispecific is in dose escalation phase, and patients are now dosed in combination -- are now being dosed in combination with Libtayo. Our MET X MET bispecific antibody is in the dose expansion state. Recall that this study is enrolling non-small cell lung cancer patients with a broad selection of patients, including MET exon 14 gene mutations, gene amplication and/or elevated MET protein expression.

關於我們在肺癌和其他實體瘤領域的早期研究，我們的EGFRxCD28共刺激雙特異性抗體正處於劑量遞增階段，目前患者正在接受聯合用藥治療——即與Libtayo聯合用藥。我們的MET x MET雙特異性抗體正處於劑量擴展階段。需要注意的是，這項研究正在招募非小細胞肺癌患者，納入的患者範圍廣泛，包括MET 14號外顯子基因突變、基因擴增和/或MET蛋白表達升高。

We believe our oncology portfolio is one of the most exciting in the field and has the potential to revolutionize the treatment of diverse, difficult-to-treat cancers. Finally, I would like to highlight our capabilities regarding the Regeneron genetic center and our genetics medicines efforts. In addition to being able to discover and validate targets that we can address with our VelociGene antibody platform, we're working with our collaborators to develop 3 additional platforms that have the potential to generate new classes of genetics-based medicines.

我們相信，我們的腫瘤產品組合是該領域最令人振奮的產品組合之一，並有望徹底改變多種難治性癌症的治療方式。最後，我想重點介紹一下我們在再生元基因中心和基因藥物研發方面的能力。除了能夠發現和驗證可利用VelociGene抗體平台進行治療的標靶外，我們還在與合作夥伴共同開發另外三個平台，這些平台有望產生新型的基因藥物。

First, gene editing. We are eagerly awaiting initial results from the first systemic based CRISPR approach to be announced midyear by our collaborator Intellia. If positive, these results will validate this gene editing platform for a host of genetic targets identified by the Regeneron Genetic center and being investigated under our collaboration with Intellia.

首先是基因編輯。我們正翹首以盼合作夥伴Intellia公司年中公佈的首個基於系統性CRISPR方法的初步結果。如果結果積極，將驗證該基因編輯平台對Regeneron基因中心已確定的、並正在我們與Intellia合作研究的一系列基因標靶的有效性。

Second, we are also excited about our Alnylam collaboration with its validated siRNA platform approach that consumably address complementary genetics targets. Our Alnylam, target ALN-HSD directed to HSD-17B13, a target discovered by the Regeneron Genetic Center, is now enrolling NASH patients. Additionally, we and Alnylam are collaborating on a series of follow-on targets. While the technology is currently validated for liver-directed therapeutic approaches, we are set to extend to eye and central nervous system targets. Our third genetic medicines approach involves viral gene therapy delivery and is another approach of significant interest and excitement at Regeneron.

其次，我們對與Alnylam的合作也感到非常興奮，他們擁有經過驗證的siRNA平台，並有望解決互補的基因標靶。我們與Alnylam合作開發的標靶HSD-17B13的ALN-HSD（該標靶由Regeneron基因中心發現）目前正在招募NASH患者。此外，我們和Alnylam正在合作開發一系列後續標靶。雖然該技術目前已驗證可用於肝臟標靶治療，但我們計劃將其擴展到眼部和中樞神經系統標靶。我們的第三種基因藥物策略是病毒載體基因療法，也是Regeneron非常關注且期待的另一種策略。

Our first gene therapy program is in collaboration with Decibel focusing on targeting the ear. We and Decile are planning to enter the clinic with DB-OTO next year. In addition to the AAVs targeting the year, we are developing a platform for use in multiple other tissues of interest. With that, I would like to turn the call over to Marion.

我們的首個基因治療課程是與 Decibel 公司合作，專注於耳部治療。我們和 Decibel 計劃明年將 DB-OTO 推進臨床試驗。除了針對耳部的 AAV 載體外，我們也正在開發一個可用於其他多種目標組織的平台。接下來，我將把發言權交給 Marion。

Thank you, George. We're off to an exciting start in 2021. Our expanded commercial portfolio includes 3 recent product and indication launches, and we continue to grow our largest brands, EYLEA, Dupixent and Libtayo, based on competitive and differentiated profiles. Beginning with EYLEA, first quarter global net sales grew 17% year-over-year to nearly $2.2 billion.

謝謝喬治。 2021年伊始，我們便取得了令人振奮的成績。我們不斷拓展的商業產品組合包括近期推出的三款新產品和新適應症，同時，我們基於自身俱有競爭力和差異化的優勢，持續推動旗下三大品牌－安麗（EYLEA）、度普利（Dupixent）和利妥昔（Libtayo）的成長。以安麗為例，其第一季全球淨銷售額年增17%，接近22億美元。

In the U.S., EYLEA net sales grew 15% year-over-year to $1.35 billion based on increased demand and a favorable comparison to the early weeks of the pandemic and the first quarter of 2020. EYLEA is capturing category growth and continues to be the preferred treatment option. In the branded anti-VEGF category, EYLEA has approximately 75% share and is approaching 50% of the combined branded and unbranded category.

在美國，由於需求成長以及與疫情初期和2020年第一季相比的良好基數效應，EYLEA的淨銷售額年增15%，達到13.5億美元。 EYLEA正在引領品類成長，並持續維持其作為首選治療方案的地位。在品牌抗VEGF藥品類別中，EYLEA的市佔率約為75%，且在品牌和非品牌藥物合計品類中，其市佔率正逼近50%。

EYLEA is differentiated by the combination of its efficacy, safety, dosing flexibility and range of indications. In addition, physicians have considerable real-world experience with more than 40 million injections administered worldwide. Across the broader category, demand continues to improve in 2021 and as patient floor normalizes and new patient volume grows, we are confident in our near and longer-term outlook based on favorable patient demographics, physician preference for EYLEA, growth opportunities in diabetic eye disease and future opportunities with our high dose clinical program.

EYLEA 的獨特之處在於其療效、安全性、劑量靈活性和適應症範圍的全面性。此外，醫生們累積了豐富的臨床實務經驗，全球已累積注射超過 4,000 萬劑。在整個眼科領域，2021 年市場需求持續成長。隨著患者數量逐漸恢復正常，新患者數量不斷增加，我們對近期和長期前景充滿信心，這主要得益於有利的患者群體特徵、醫生對 EYLEA 的偏好、糖尿病眼病領域的增長機會以及我們高劑量臨床項目的未來發展前景。

Turning to Libtayo. First quarter global net sales grew to $101 million, with U.S. net sales of $69 million, the vast majority of first quarter sales were in cutaneous squamous cell carcinoma, where Libtayo is the #1 systemic treatment. We're excited by recent approvals in non-small cell lung cancer and basal cell carcinoma, or BCC, both of which represent meaningful growth opportunities for Libtayo. In April, we deployed our expanded and highly experienced field force across these indications to extend our Libtayo promotional impact.

接下來談談利妥昔單抗（Libtayo）。第一季全球淨銷售額成長至1.01億美元，其中美國淨銷售額為6,900萬美元。第一季銷售額的絕大部分來自皮膚鱗狀細胞癌，利妥昔單抗是該領域排名第一的全身性治療藥物。我們對利妥昔單抗近期獲準用於非小細胞肺癌和基底細胞癌（BCC）感到振奮，這兩個適應症都為利妥昔單抗帶來了重要的成長機會。 4月份，我們已在上述適應症領域部署了規模更大、經驗豐富的銷售團隊，以擴大利妥昔單抗的推廣影響力。

In lung cancer, we have heard from oncologists that Libtayo is highly competitive based on the strength of our compelling clinical data and overall value proposition. Early launch indicators are encouraging with uptake evidence at top academic and community-based practices. We're advancing formulary placement, securing favorable payer coverage decisions and growing overall market awareness.

在肺癌領域，我們從腫瘤科醫師那裡了解到，Libtayo憑藉其強而有力的臨床數據和整體價值主張，極具競爭力。早期上市指標令人鼓舞，在頂尖學術機構和社區醫療機構都有應用。我們正在推進Libtayo納入藥品目錄，爭取獲得有利的健保覆蓋，並提升整體市場認知度。

Importantly, Libtayo was rapidly included in the NCCN guidelines with a Category 1 preferred rating. The NCCN guidelines have also been updated to include Libtayo in BCC as the category IIa option, Libtayo is the only anti-PD-1 approved in advanced disease for this indication. Early feedback has been encouraging as physicians are eager to prescribe Libtayo based on its efficacy and tolerability. Hedgehog inhibitors despite being used as first-line treatment may not be suitable for patients for long-term or repeat use. Libtayo is an important new care alternative for BCC patients.

值得注意的是，Libtayo 迅速被納入 NCCN 指南，並被評為 1 類首選藥物。 NCCN 指引也已更新，將 Libtayo 納入基底細胞癌 (BCC) 的 IIa 類治療方案。 Libtayo 是目前唯一獲準用於治療晚期 BCC 的抗 PD-1 藥物。早期回饋令人鼓舞，醫生們基於 Libtayo 的療效和耐受性，積極為其開立處方。儘管 Hedgehog 抑制劑被用作一線治療，但可能不適合患者長期或重複使用。 Libtayo 為 BCC 患者提供了一個重要的全新治療選擇。

In summary, our lung and BCC launches are progressing according to plan, and we are highly focused on ensuring that appropriate patients benefit from Libtayo.

總而言之，我們的肺癌和基底細胞癌藥物上市工作正在按計劃進行，我們高度重視確保合適的患者能夠從 Libtayo 中受益。

Turning now to Obtusa, which was also approved in the first quarter of 2021 and is in the initial launch phase. Obtusa represents a novel and effective treatment for patients with homozygous familial hypercholesteremia and is recognized by treating specialists as an improvement over the current standard of care. Patient demand is steadily building with multiple patients already initiated on therapy.

接下來介紹Obtusa，該藥也於2021年第一季獲批，目前正處於初期上市階段。 Obtusa是一種新型有效的純合子家族性高膽固醇血症治療方案，被治療專家公認為優於目前的標準療法。患者需求正穩定成長，已有不少患者開始接受治療。

Moving to Dupixent. Global net sales in the first quarter were $1.26 billion, representing 48% growth compared to the prior year. In the U.S., broad-based growth across all approved indications generated net sales of $962 million, with the new patient starts now higher than pre-COVID levels. In atopic dermatitis, Dupixent's largest indication, prescribing continues to be strong across both moderate and severe disease and across age groups following our adolescent and pediatric launches. There's significant opportunity for continued growth based on remaining unmet need among eligible patients.

接下來談談Dupixent。第一季全球淨銷售額為12.6億美元，較去年同期成長48%。在美國，所有已核准適應症均實現全面成長，淨銷售額達9.62億美元，新病患用藥量已超過新冠疫情前的水準。在Dupixent最大的適應症－異位性皮膚炎方面，繼青少年和兒童用藥上市後，中重度患者以及各年齡層的處方量依然強勁。基於符合條件的患者中仍存在未被滿足的需求，Dupixent仍有巨大的成長潛力。

Dupixent is the #1 dermatologist prescribed biologic based on the depth and breadth of its long-term efficacy and safety profile. Turning to asthma, where we are actively preparing to launch in pediatric patients as young as 6 years of age later this year. Among adolescents and adults, we continue to meaningfully expand the number of Dupixent patients' initiations, driven by our extensive provider and patient educational efforts.

杜必妥（Dupixent）是皮膚科醫生處方量排名第一的生物製劑，這得益於其長期療效和安全性方面的深度和廣度。在氣喘治療方面，我們正積極籌備於今年稍晚在6歲及以上兒童患者中推出杜必妥。在青少年和成人患者中，我們透過廣泛的醫病教育工作，持續大幅擴大杜必妥的使用人群。

In addition, demand is strong among ENTs and Allergists for patients with nasal polyps. Dupixent is the fastest-growing biologic in respiratory disease in our approved indications with substantial room for growth. I'd also like to highlight efforts supporting our antibody cocktail, REGEN-COV. In the first quarter, we recorded U.S. net sales of $262 million under the first contract with U.S. government.

此外，耳鼻喉科醫生和過敏科醫生對鼻息肉患者的需求強勁。 Dupixent 是我們已核准適應症中呼吸系統疾病生物製劑中成長最快的，且仍有龐大的成長空間。我還想重點介紹一下我們為抗體雞尾酒療法 REGEN-COV 所做的努力。第一季度，根據與美國政府簽訂的首份合同，我們在美國實現了 2.62 億美元的淨銷售額。

REGEN-COV is currently authorized under an EUA in patients based on age and risk factors, which represent close to 40% of all adults diagnosed with COVID-19. We're focused on reducing bottlenecks and increasing utilization, particularly in states with high infection rates. Efforts include direct support to key facilities, medical education about REGEN-COV, partnering with third-party stakeholders and educating consumers on the availability of antibody treatments.

REGEN-COV目前已獲得緊急使用授權（EUA），可用於符合特定年齡和風險因素的患者，這些患者約佔所有COVID-19確診成年患者的40%。我們正致力於減少瓶頸並提高藥物利用率，尤其是在感染率高的州。相關工作包括直接支持重點醫療機構、進行REGEN-COV相關醫學教育、與第三方利益相關者合作以及向消費者普及抗體療法的可及性。

As George mentioned, we're preparing for a potential update of the REGEN-COV EUA to include prevention as we hope to be able to address an unmet need for millions of patients who may be candidates for ongoing preventative treatment. Preventative therapy may also be important for those who have known COVID exposure and require very rapid protection.

正如喬治所提到的，我們正在準備更新 REGEN-COV 緊急使用授權，以納入預防用途，因為我們希望能夠滿足數百萬個可能需要持續預防性治療的患者的需求。對於已知接觸過新冠病毒且需要迅速獲得保護的人來說，預防性治療也可能至關重要。

In summary, we delivered robust performance across our portfolio in the first quarter of the year. There's strong positive momentum from our in-line business, encouraging early signals from our recent launches and substantial opportunity for continued diversified growth. Now I'll turn the call over to Bob.

總而言之，今年第一季我們旗下所有產品組合都取得了強勁的業績。現有業務發展勢頭良好，近期推出的產品也展現出令人鼓舞的早期跡象，我們擁有持續多元化成長的巨大潛力。現在我將把電話會議交給鮑伯。

Thanks, Mary, and good morning and afternoon to everyone listening to the call. My comments today are on financial results, and outlook will be on a non-GAAP basis where applicable. As Len stated, Regeneron is off to a strong start in 2021 as we continue to execute across the business, delivering double-digit top and bottom line growth in the first quarter. For the first quarter, total revenues grew 38% year-over-year to $2.5 billion, driven by growth in global EYLEA sales, increased Sanofi collaboration profitability driven by Dupixent and sales of our REGEN-COV antibody cocktail.

謝謝瑪麗，也祝各位早安/午安。我今天主要談財務業績，展望部分將依據非GAAP準則進行。正如倫所說，隨著我們持續推進各項業務，Regeneron在2021年開局強勁，第一季營收和利潤均實現了兩位數成長。第一季總營收年增38%至25億美元，主要得益於全球EYLEA銷售額的成長、Dupixent帶來的賽諾菲合作獲利能力提升以及REGEN-COV抗體雞尾酒療法的銷售成長。

Diluted net income per share grew 50% year-over-year to $9.89 on net income of $1.1 billion. Excluding revenues related to REGEN-COV, Regeneron achieved 20% total revenue growth versus the prior year. As you heard from Marion, we completed our initial contract to supply REGEN-COV to the U.S. government in the first quarter. Assuming that we secure an updated EUA for the 1.2 gram treatment dose, we expect to deliver at least 1 million doses of REGEN-COV at $2,100 per dose for our follow-on contract with the U.S. government in the second quarter.

稀釋後每股淨收益年增50%至9.89美元，淨利達11億美元。若不計入與REGEN-COV相關的收入，Regeneron的總收入較前一年成長20%。正如Marion所說，我們已於第一季完成了向美國政府供應REGEN-COV的首份合約。假設我們能夠獲得1.2克治療劑量的緊急使用授權（EUA）更新，我們預計將在第二季度根據與美國政府的後續合同，以每劑2100美元的價格交付至少100萬劑REGEN-COV。

I will now move to collaboration revenues, which were $754 million in the first quarter of 2021 compared to $528 million in the first quarter of 2020. Starting with the Bayer collaboration. Ex U.S. EYLEA net product sales reported to us by Bayer were $824 million for the first quarter of 2021 representing growth of 21% on a reported basis and 12% on a constant currency basis compared to the prior year. Total Bayer collaboration revenue was $323 million of which we recorded $309 million for our share of net profits from EYLEA sales outside the U.S.

接下來我將介紹合作收入，2021年第一季為7.54億美元，而2020年第一季為5.28億美元。首先是與拜耳的合作。拜耳向我們報告的2021年第一季美國以外地區EYLEA淨產品銷售額為8.24億美元，按報告匯率計算年增21%，以固定匯率計算年增12%。拜耳合作總收入為3.23億美元，其中我們確認了3.09億美元為EYLEA美國以外地區銷售淨利的份額。

Total Sanofi collaboration revenue was $365 million in the first quarter. Our share of the profits from the commercialization of Dupixent and Kevzara was $261 million, which compares favorably to profits of $171 million in the prior year driven by Dupixent. We recorded initial gross collaboration revenues of $67 million for our share of gross profits from the distribution of the antibody cocktail by Roche outside of the U.S. Other revenue decreased to $50 million in the first quarter compared to $63 million in the prior year. In 2021, we expect this line to be less than half of what we recorded in 2020 due to lower BARDA reimbursements for the Ebola and COVID-19 programs.

第一季度，賽諾菲合作總營收為3.65億美元。我們從Dupixent和Kevzara的商業化中獲得的利潤份額為2.61億美元，較上年同期Dupixent帶來的1.71億美元利潤有所增長。我們從羅氏在美國以外地區分銷抗體雞尾酒療法中獲得的毛利份額，確認了6,700萬美元的初始合作總收入。其他收入從去年同期的6,300萬美元降至第一季的5,000萬美元。由於美國生物醫學高級研究與發展局（BARDA）對伊波拉和新冠肺炎計畫的報銷額度降低，我們預計2021年該收入將不到2020年的一半。

Moving on to our operating expenses and starting with R&D. R&D increased 28% year-over-year to $673 million, primarily due to continued clinical development costs for our REGEN-COV antibody cocktail. Next, SG&A expense increased 16% year-over-year to $355 million. The year-over-year increase was driven by commercial investments for Libtayo, costs related to the rollout of REGEN-COV and higher employee-related expenses.

接下來是營運費用，首先是研發費用。研發費用年增28%至6.73億美元，主要原因是REGEN-COV抗體雞尾酒療法的持續臨床開發成本。其次，銷售、管理及行政費用較去年同期成長16%至3.55億美元。年比成長主要受Libtayo商業投資、REGEN-COV推廣相關成本以及員工相關費用增加的影響。

Cost of goods sold increased versus the prior year from $70 million to $173 million due to REGEN-COV manufacturing costs and Praluent manufacturing costs in the U.S., which were recorded by Sanofi in the first quarter of 2020. Additionally, in other income and expense, we recorded $4 million of expense compared to $25 million of income in the prior year. This is driven by interest expense related to our $2 billion debt issuance in August 2020 and lower investment returns on our existing cash and marketable securities.

由於賽諾菲在2020年第一季計入了REGEN-COV和Praluent在美國的生產成本，銷售成本較上年同期從7,000萬美元增至1.73億美元。此外，在其他收入和支出方面，我們錄得支出400萬美元，而上年同期為收入2500萬美元。這主要是由於2020年8月發行20億美元債券產生的利息支出，以及現有現金和有價證券的投資報酬率下降。

Finally, the effective tax rate was 10.5% in the first quarter of 2021. Included in this rate is the benefit achieved by a reduction in uncertain tax position liabilities related to the IRS audits of the 2015 and 2016 tax years. Shifting now to cash flow and the balance sheet. In the first quarter of 2021, Regeneron generated $553 million in free cash flow and ended the quarter with net cash and marketable securities of $5.1 billion.

最後，2021年第一季的實際稅率為10.5%。該稅率包含了因2015和2016納稅年度美國國稅局審計而導致的未決稅務負債減少所帶來的收益。接下來我們來看現金流和資產負債表。 2021年第一季，Regeneron公司產生了5.53億美元的自由現金流，季度末淨現金及有價證券為51億美元。

In the first quarter, we utilized $323 million of our $1.5 billion share repurchase authorization, and we remain opportunistic buyers in the market. I would now like to provide select updates to our 2021 guidance. A complete summary of our latest full year guidance is available in our press release published earlier this morning.

第一季度，我們使用了15億美元股票回購授權額度中的3.23億美元，我們仍然是市場上的機會主義買家。現在，我想就我們2021年的業績指引做一些更新。我們最新的全年業績指引的完整摘要已在今天早些時候發布的新聞稿中提供。

We are updating full year 2021 guidance for COCM to be in the range of $660 million to $730 million, the lower guidance range is related to the timing of contract manufacturing of Praluent for Sanofi. We are also updating guidance for our 2021 non-GAAP effective tax rate to be in the range of 13% to 15%. The increase from prior guidance is driven by higher forecasted delivery of REGEN-COV under our second U.S. government contract, which is taxed at the U.S. statutory rate.

我們將2021財年COCM（合約生產製造）的全年業績預期更新為6.6億美元至7.3億美元，較低的預期範圍與賽諾菲Praluent的合約生產時間有關。同時，我們將2021財年非GAAP有效稅率的預期更新為13%至15%。較先前預期有所上調，主要原因是預計根據我們第二份美國政府合約交付的REGEN-COV產品數量將增加，而該產品將按美國法定稅率徵稅。

In conclusion, Regeneron is off to a strong start in 2021 and continues to execute across all aspects of the business. We are well positioned for the remainder of 2021 and continue to make those investments necessary to ensure long-term growth. With that, I would now like to turn the call back to Justin.

總之，Regeneron在2021年開局強勁，並在業務的各個方面持續取得進展。我們已為2021年剩餘時間做好充分準備，並將繼續進行必要的投資，以確保長期成長。接下來，我將把發言權交還給Justin。

Thank you, Bob. Mary, that concludes our prepared remarks. We'd now like to open the call for Q&A.

謝謝鮑勃。瑪麗，我們的演講稿到此結束。現在我們進入問答環節。

(Operator Instructions)

（操作說明）

Please go ahead, Mary.

請繼續，瑪麗。

(Operator Instructions)

（操作說明）

Your first question comes from the line of Terence Flynn of Goldman Sachs.

你的第一個問題出自高盛的特倫斯·弗林之口。

Great. I guess, with respect to the competitive landscape for Dupixent, the JAK inhibitors have been delayed. But assuming they do reach the market later this year, including at the high dose, how are you guys thinking about that as a competitive headwind to Dupixent? And maybe as you think about the longer term market opportunity, you could walk us through kind of where penetration stands right now in the adult and the adolescent setting?

好的。我想，就Dupixent的競爭格局而言，JAK抑制劑的上市時間有所延遲。但假設它們能在今年稍後上市，包括高劑量版本，你們認為這會對Dupixent構成怎樣的競爭阻力？另外，在考慮長期市場機會時，能否介紹一下目前JAK抑制劑在成人和青少年市場的滲透率？

Go ahead, Marion.

請繼續，瑪莉安。

Sure. So I'm happy to start off. First, let me say that we are seeing tremendous experience with Dupixent in the marketplace today. And this obviously is across indications, including atopic dermatitis and also very importantly, across age categories, which demonstrate not only the efficacy, the speed of action, the safety, the tolerability, we pay really close attention to competitives coming into the marketplace. And certainly, in the case of the JAK inhibitors, we're well aware of the multiple delays.

當然。我很樂意開始。首先，我想說的是，目前市面上Dupixent的療效顯著。這顯然涵蓋了各種適應症，包括異位性皮膚炎，而且非常重要的一點是，涵蓋了各個年齡段，這不僅證明了其療效、起效速度、安全性和耐受性，也體現了這一點。我們密切關注著市場上湧現的競爭對手。當然，就JAK抑制劑而言，我們也清楚意識到其上市時間多次延誤的問題。

Also recent clinical data that is calling into question, issues of safety, especially at the higher doses. But even at the lower doses and the continuation of black box warnings, we hear from our key opinion leaders who use Dupixent and see it as their mainstay of therapy currently and going forward with great confidence in the safety profile.

此外，近期的一些臨床數據也對安全性提出了質疑，尤其是在高劑量下。但即使在低劑量下，儘管黑框警告仍然存在，我們仍然從使用Dupixent的關鍵意見領袖那裡了解到，他們目前和未來都將Dupixent作為主要的治療方案，並對其安全性充滿信心。

This is a chronic therapy. And certainly, the risk of hematologic effects, malignancies, infection and so on are just not something that is tolerable for these patients when they have a tremendous alternative. So I think we feel very confident in our competitive profile going forward. And also remind that Dupixent, obviously, based on its mode of action, has great efficacy across type 2 disease and other indications. Patients do sometimes have concomitant conditions so on balance, we'll stay very close to this and to our key opinion leaders and specialists, who are very, very confident in the profile of Dupixent.

這是一種長期治療。當然，血液系統副作用、惡性腫瘤、感染等風險對於這些患者來說，在有如此顯著的替代療法的情況下，是完全無法承受的。因此，我們對未來的競爭優勢充滿信心。同時，也需要強調的是，Dupixent 的作用機制使其在第 2 型糖尿病及其他適應症中均展現出卓越的療效。患者有時會伴隨其他疾病，因此，我們會密切注意這種情況，並與那些對 Dupixent 的療效充滿信心的關鍵意見領袖和專家保持密切溝通。

Yes. I would just add 2 points that. One is the safety will be particularly concerning, I think, for the long-term treatment of children. And so I think the safety profile that Dupixent has shown is really, frankly, it's almost in parallel in terms of what you can do with the agent on the efficacy side and not have any significant concerns on the safety side. The other point in terms of the penetration, even if you look at how these markets have evolved, when more agents have come on for rheumatoid arthritis and for psoriasis.

是的。我只想補充兩點。第一點是安全性，我認為對於兒童的長期治療來說尤其令人擔憂。坦白說，我認為Dupixent展現出的安全性幾乎與療效方面不相上下，而且安全性方面也沒有什麼重大隱患。第二點是關於市場滲透率，即使考慮到這些市場的發展，以及更多治療類風濕性關節炎和銀屑病的藥物的出現，也需要進一步研究。

The penetration is so low here that even with competition, there is room for market growth rather than direct fighting it out in terms of a fixed amount of market share. So we expect our profile safety, as Marion says, to be really paramount in treating physicians' minds. And we do think the low level of penetration thus far does leave room for growth nonetheless.

目前該領域的市場滲透率極低，即使存在競爭，市場仍有成長空間，而非僅圍繞固定的市佔率直接競爭。因此，正如瑪麗昂所說，我們預計我們產品的安全性將成為醫生最關注的重點。而且，我們認為目前較低的市場滲透率也意味著未來仍有成長空間。

Next question comes from the line of Chris Raymond of Piper Sandler.

下一個問題來自 Piper Sandler 的 Chris Raymond。

Yes. Just maybe another question on Dupixent. So our checks indicate there's a lot of interest in AD with regard to add on therapy. And that there's a lot of Dupixent patients who may not be necessarily optimally managed but are not exactly failing. So there's a lot of interest, I guess, with maybe looking at a topical JAK or some other therapy. Just kind of curious if you guys have thought about maybe proactively looking at some combo work just to sort of ensure that Dupixent maintains its role as a core?

是的。關於Dupixent，我可能還有一個問題。我們的調查顯示，在AD的附加療法方面，大家非常感興趣。而且，很多Dupixent患者可能沒有得到最佳治療，但也沒有完全失敗。所以我想，大家對局部JAK抑制劑或其他療法很有興趣。我只是好奇，你們是否考慮積極進行聯合治療研究，以確保Dupixent繼續保持其核心治療的地位？

Well, George might want to comment if we have any interest in it. But in terms of the commercial side of this, when you talk to patients, the kind of patients we're treating moderate to severe atopic dermatitis. They have lesions over large fraction of their body. I can't remember exactly what it was in our trials. But what we're seeing out there commercially is large fractions of their body are affected by this disease. And so I think that adding topicals, perhaps, but people are actually trying to get away from having to lather up over their entire body.

嗯，如果喬治對此有興趣，他或許會發表一些看法。但就商業層面而言，當你與患者交談時，你會發現，我們治療的這類中重度異位性皮膚炎患者，他們的皮損遍布全身大部分區域。我記不清我們試驗中的具體情況了。但我們在市場上看到的情況是，這種疾病影響了他們身體的大部分區域。所以我認為，或許可以添加外用藥物，但人們實際上更希望避免全身塗抹。

The other thing about Dupixent that we can never forget is that the broad aspects of approvals across lots of allergic diseases and with a growing number is very important because these diseases do tend to run in groups. There are many people who have asthma and atopic dermatitis or asthma and nasal polyposis or atopic dermatitis and other allergic diseases, which we're studying.

關於Dupixent，我們永遠不能忘記的一點是，它在多種過敏性疾病領域獲得廣泛批准，而且這些疾病的適應症還在不斷增加，這一點非常重要，因為這些疾病往往呈現群發性。許多患者同時患有氣喘和異位性皮膚炎、氣喘和鼻息肉，或異位性皮膚炎以及其他過敏性疾病，我們正在研究這些疾病。

So I think that our broad profile across lots of other diseases is also going to give us a very strong competitive position.

所以我認為，我們在許多其他疾病領域的廣泛優勢也將使我們擁有非常強大的競爭地位。

Yes, I can -- I'm just going to add real quickly. This is Marion. On that question, I just wanted to share as well that in the market experience, we do and obviously look at this very carefully through market research, have a very high level of satisfaction with Dupixent for patients with atopic dermatitis. So I just want to make sure that there's not an impression left that there are a lot of patients necessarily looking for something more who are treated with Dupixent for atopic dermatitis.

是的，我可以──我再補充一點。我是瑪莉安。關於這個問題，我還想分享一下，根據市場經驗，我們透過市場調查非常仔細地分析了這一點，發現杜必妥（Dupixent）在治療異位性皮膚炎方面擁有非常高的滿意度。所以我只是想澄清一下，不要讓大家誤以為有很多接受杜必妥治療異位性皮膚炎的患者在尋求其他更好的治療方案。

Next question comes from Cory Kasimov with JPMorgan.

下一個問題來自摩根大通的科里·卡西莫夫。

Wanted to ask on the COVID front. Do you have a sense of the remaining hurdles and anticipated timing for the low dose emergency use authorization for REGEN-COV? And are you continuing to ship high doses of the antibody cocktail as you wait on it?

我想問一下關於新冠疫​​情方面的問題。您是否了解低劑量REGEN-COV緊急使用授權的剩餘障礙和預計時間？在等待授權期間，您是否仍在繼續出貨高劑量抗體雞尾酒療法？

Thanks for that question, Cory. We've been in active discussions and productive discussions with the FDA. Obviously, one never knows what they're going to do, exactly when they're going to do it. But we anticipate an action by the FDA over the next -- sometime in the next several weeks in terms of the lower 1.2 gram dose. I think from there, they will turn their attention to the prevention data, which they have in front of them as well as the subcu data as well as the chronic prevention opportunity.

謝謝你的提問，科里。我們一直在與FDA進行積極且有成效的討論。當然，誰也無法確切知道自己會做什麼，以及何時採取行動。但我們預計FDA會在未來幾週內，就1.2克較低劑量採取行動。我認為，之後他們會將注意力轉向他們掌握的預防數據、皮下注射數據以及慢性預防的機會。

So I can assure you the FDA has been working really hard. We're in constant contact with them, answering questions, going over things. And as I said, we expect something to anticipate decision sometime in the next several weeks.

我可以向你們保證，FDA一直在非常努力地工作。我們與他們保持密切聯繫，解答疑問，討論相關事宜。正如我所說，我們預計在未來幾週內會有一些初步的決定出爐。

And Cory, I'm sorry, you -- of course, we're continuing to supply the market. There's no shortage of product out there in terms of people needing to be treated now, can be treated with the 2.4 gram dose. And there's ample product available.

科里，我很抱歉，你——當然，我們一直在向市場供貨。目前市面上產品供應充足，需要治療的人都可以用2.4克的劑量進行治療。而且產品供應充足。

Next question comes from Geoffrey Porges of SVB Leerink.

下一個問題來自SVB Leerink的Geoffrey Porges。

So many things to ask questions about and so little time. Bob, operating margin, 48% to 49% the last couple of quarters, what would that have been without the CoV-2, the antibody? And is it sustainable at the current level? And I'll squeeze in, and is the tax rate sustainable at the current level as well?

想問的問題太多，時間卻太少。鮑勃，過去幾季的營業利潤率在48%到49%之間，如果沒有新冠病毒和抗體，利潤率會是多少？目前的水平能持續嗎？我再插一句，目前的稅率也能持續嗎？

Yes. I mean, I'll talk about the tax rate. I mean, certainly, there's a lot to be played out with regards to what's going to happen on the tax rate. You heard what I said, we're obviously a little lower than our full year guidance. We did have a favorable outcome with regards to uncertain tax positions that we were able to reverse which kind of drove a little lower in the quarter on that front.

是的。我會談談稅率。當然，稅率的走向還有很多變數。你們也聽到了，我們目前的業績顯然略低於全年預期。我們之前在稅務方面存在一些不確定因素，但最終得到了積極的解決，這使得本季的業績略有下降。

On operating margins, Geoff, I guess the one piece that's not so transparent to everybody is we're still incurring a lot of R&D as it pertains to REGEN-COV with regards to the trials, the enrollment numbers. So I don't want people to come away and say, as a result of the Roche benefit we got in the REGEN-COV product sales that without that the margins wouldn't have been as good, but we did incur a lot of expenses pertaining to that, that aren't within the R&D line that we just don't specifically talk about.

關於營業利潤率，Geoff，我想有一點可能不太為人所知，那就是我們仍在為 REGEN-COV 的臨床試驗和入組人數投入大量研發資金。所以我不想讓大家誤以為，由於羅氏在 REGEN-COV 產品銷售方面給予的收益，如果沒有這筆資金，我們的利潤率就不會這麼好。但我們確實為此負擔了許多費用，這些費用並不屬於研發範疇，只是我們沒有具體提及而已。

The business on its own, excluding REGEN-COV was 20% top line and 35% EBIT, okay? So again, it shows you the underlying strength, as you've heard from Len at the very beginning of his words in terms of how we're performing. We think the operating margin is -- can continue to stay at that and improve at that level. I mean, certainly, it's the leverage on Dupixent, right, to the extent -- you saw that Sanofi did a terrific job ex U.S. where we're starting to get a little momentum in terms of ex U.S. sales. So to the extent that, that will continue to play out, we'll continue to get good operating margins associated with that, and then that will drive our overall margins.

剔除 REGEN-COV 後，該業務本身的營收佔比為 20%，息稅前利潤佔比為 35%，懂嗎？所以，正如您從 Len 的開場白中聽到的，這再次展現了我們業務的潛在實力。我們認為營業利潤率可以繼續維持並在此水準上有所提升。當然，這與 Dupixent 的槓桿效應密切相關，對吧？正如您所看到的，賽諾菲在美國以外的市場表現出色，而我們在美國以外的銷售額也開始出現成長勢頭。因此，如果這種情況能夠持續下去，我們將繼續獲得良好的營業利潤率，進而推動我們的整體利潤率成長。

Next question comes from Yatin Suneja of Guggenheim Partners.

下一個問題來自古根漢合夥公司的亞廷·蘇內賈。

I have question on the deployment of cash. Could you maybe talk about the top priorities? Are there areas where you would like to collaborate or bring in capabilities? And how should we think about BD?

我有一個關於資金部署的問題。您能否談談當前的首要任務？您希望在哪些領域開展合作或引入相關能力？我們該如何看待業務拓展？

Bob?

鮑伯？

Sure. Our cash balance on a net cash base is sitting at $5.1 billion, and we're roughly at $7 billion on a gross basis. And again, we like the flexibility that it affords us. I always need to make sure that internally, we have enough to obviously support the internal R&D, of which we continue to go after different modalities, and that's kind of tied into our second leg of the stool where we don't have kind of in-house capability on everything.

當然。我們目前的淨現金餘額為51億美元，總現金餘額約為70億美元。我們很看重這種靈活性。我始終需要確保公司內部有足夠的資金來支持內部研發，我們一直在探索不同的研發模式，這與我們公司的另一個主要優勢——並非所有領域都具備內部研發能力——密切相關。

It's great that we have the capability for George and the BD team to go out and get other technologies, whether it be the Intellia driven technology on CRISPR, or Alnylam and the like. And we're continuing to play heavy in that space, and we need to make sure that things we go after are most likely going to be early stage. We're not looking for kind of transformative kind of M&A deals on that front as of right now, and we continue to stay hungry in that place with the right opportunities.

喬治和業務拓展團隊有能力去收購其他技術，這真是太好了，無論是Intellia的CRISPR技術，還是Alnylam等公司的技術。我們將繼續大力拓展這一領域，並且需要確保我們收購的目標大多處於早期階段。目前，我們並不尋求在該領域進行變革性的併購交易，但我們會繼續保持對這一領域的熱情，只要有合適的機會。

And then as you saw, we did $325 million of share buybacks. We have a $1.5 billion program that we authorized in January. We are opportunistic buyers when we think the intrinsic value of where we see it compared to where the market is currently playing, we are going to take advantage of that -- of that delta, and we did such that in the first quarter, and we're continuing to do that on that front. And that continues to be an active play for us.

如您所見，我們進行了3.25億美元的股票回購。我們還有一項15億美元的回購計劃，已於1月獲得批准。我們善於把握機會，當我們認為某檔股票的內在價值高於當前市場水準時，我們會抓住這個機會進行回購。我們在第一季就採取了這樣的策略，並且會繼續推進。這仍然是我們積極開展的一項業務。

Next question comes from Geoff Meacham of Bank of America.

下一個問題來自美國銀行的傑夫‧米查姆。

This is Alec on for Geoff. Just one on EYLEA. Obviously, scripts and sales are holding up fairly well despite COVID-19 and new market entrants in wet AMD. But looking to life cycle management over the next few years, do you see this primarily coming from the high dose formulation? And on this, is there a venue or an update on timing for data on the CANDELA study?

這裡是Alec替Geoff發言。關於愛立信（EYLEA），顯然，儘管受到新冠疫情和濕性老年黃斑部病變（AMD）新藥市場競爭的影響，處方量和銷售額依然保持良好。但展望未來幾年的生命週期管理，您認為這主要會來自高劑量製劑嗎？另外，關於CANDELA研究的數據，是否有公佈的計畫或時間安排？

Yes. I think that the life cycle management continues to be from more data, the kind of data that we generated in diabetic retinopathy with the Panorama and Protocol W, which George reviewed, I think, are very important results. And so I think that will drive more treatment in that area. In terms of the high dose, I think you heard from George, that we'll get some of the preliminary Phase II data later this year. And then we -- for next entrance, and we have readying for the clinic, a newer version, if you will, which we'll unveil for you when we get that into the clinic.

是的。我認為生命週期管理將繼續依賴更多的數據，例如我們利用Panorama和Protocol W在糖尿病視網膜病變領域產生的數據（George也審查過這些數據），我認為這些數據非常重要。因此，我認為這將推動該領域更多的治療。關於高劑量，我想您已經從George那裡了解到，我們將在今年稍後獲得一些初步的II期臨床試驗數據。然後，對於下一個入組方案，我們正在準備一個更新的版本，如果您願意這麼稱呼的話，我們會在它進入臨床試驗階段時向您公佈。

Next question comes from Robyn Karnauskas of Truist.

下一個問題來自 Truist 的 Robyn Karnauskas。

I'm scared to ask this question, but what is your latest thoughts on counter detailing faricimab? What are you hearing from the specific centers that you think might be more likely utilize the products? And how do you counter detail and prevent that from taking any share from EYLEA?

我很害怕問這個問題，但您對法瑞西單抗的櫃檯推廣有什麼最新看法？您從您認為更有可能使用這些產品的特定中心了解到的情況如何？您如何進行櫃檯推廣，才能防止它搶走安永的市場份額？

Sure. So let me say, first of all, obviously, the product you mentioned is not approved. And still at the stage where the clinical data is being reviewed. As I mentioned to some of you who are in the last call, as we look at the clinical profile today of faricimab, we do not see a threat to EYLEA. Certainly, some of the recent data had some questions on clinical profile and certainly, with an increase in IOI rate question on the safety profile. I think the net conclusion on the key opinion leaders that I spoke to in the retinal community was that they didn't see an obvious benefit to the product and perhaps even questions in matching the safety, durability and clinical profile of Eylea across indications.

當然。首先，很顯然，您提到的產品尚未獲批，目前仍處於臨床數據審查階段。正如我上次電話會議中提到的，根據我們目前對法瑞西單抗（faricimab）臨床數據的分析，我們認為它不會對艾力達（Eylea）構成威脅。當然，最近的一些數據確實對法瑞西單抗的臨床療效提出了一些疑問，尤其是眼內發炎發生率的增加，也讓人對其安全性產生了一些擔憂。我認為，我與視網膜領域的關鍵意見領袖交流後得出的最終結論是，他們認為該產品並沒有明顯的優勢，甚至在安全性、持久性和臨床療效方面，法瑞西單抗在不同適應症上的療效可能與艾力達（Eylea）存在差異。

I'll mention that certainly with EYLEA, one of important attribute is the ability to treat and extend therapy. And there are some elements of that clinical trial design that constrained EYLEA's dosing interval. We actually hear on a regular basis that one of the reasons why EYLEA is performing so well in the first quarter of 2021 and frankly, performed so well last year is because of its efficacy and the ability to treat and extend for patients.

我要特別指出的是，EYLEA 的一個重要優勢在於其治療和延長療程的能力。臨床試驗設計中的一些因素限制了 EYLEA 的給藥間隔。事實上，我們經常聽到這樣的說法：EYLEA 在 2021 年第一季表現如此出色，以及去年表現如此出色，原因之一就是它的療效以及治療和延長療程的能力。

We remain very confident in EYLEA's profile against the competitive product you mentioned.

我們仍然非常有信心安永相對於您所提到的競爭產品的優勢。

Next question comes from Alethia Young of Cantor Federal.

下一個問題來自 Cantor Federal 公司的 Alethia Young。

Congrats on the progress this quarter. I just want to talk a little bit about the 6 to 11 asthma expansion indications. Just can you kind of talk about how you're thinking about uptick there? It feels like it could be pretty robust in light of the safety profile and the fact that kids are on their atopic march as well. So I just wanted to get your perspective on that.

恭喜本季的進展。我想稍微談談6至11種氣喘適應症的擴展。您能否談談您對這部分成長的看法？考慮到該藥物的安全性以及兒童也處於特異性疾病發展階段，感覺這部分增長可能相當強勁。所以我想聽聽您的看法。

Sure. You mentioned something that we look forward to, and we'll be very much prepared for the pediatric launch for Dupixent in the asthma market later this year. We do see this as a tremendous opportunities for these really young patients, age 6 and up who are struggling today and will benefit tremendously from the Dupixent ability to improve their airway function and reduce exacerbations and help these patients and their families with these children living more normal and healthy lives. It's very important.

當然。您提到的正是我們非常期待的，我們將為今年稍後Dupixent在氣喘市場的兒科上市做好充分準備。我們認為這對6歲及以上的兒童氣喘患者來說是一個絕佳的機會，他們目前正飽受氣喘困擾，而Dupixent能夠改善他們的氣道功能，減少氣喘急性發作，幫助他們及其家人讓孩子們過上更正常、更健康的生活，這將使他們受益匪淺。這非常重要。

And then at the same time, recognizing Dupixent's safety profile. So at the same time, we take care of the asthma, and as Len mentioned before, the possibility of concomitant disease is associated with type 2 disease. So we do feel that this will be a very important indication launch. We look forward to it. And it once again confirms the efficacy and the safety of Dupixent.

同時，我們也充分認識到Dupixent的安全性。因此，在治療氣喘的同時，如Len先前提到的，2型氣喘患者可能有合併其他疾病的風險。所以我們認為，此次適應症的上市將非常重要。我們對此充滿期待。這也再次印證了Dupixent的療效和安全性。

Next question comes from Mohit Bansal of Citigroup.

下一個問題來自花旗集團的莫希特·班薩爾。

Congrats on the progress. One more question on the high growth EYLEA. So we do know that back in the day, Roche also ran a trial -- a [hybrid trial which did not work out well] I understand that the trial -- this trial design is really different. It is (inaudible) trial that you are running. But could that be helpful? That's the first question. Then I mean, scientifically, why would a high dose would result into some kind of better benefit in your opinion? That -- just to give us some confidence there.

恭喜取得進展。關於高成長的安眠藥EYLEA，我還有一個問題。我們知道，羅氏之前也做過一項試驗──一項混合試驗，但結果並不理想。我了解到，你們正在進行的試驗設計與先前的試驗截然不同。但你們的試驗設計與之前的試驗設計有差別。但羅氏的試驗設計是否對你們有幫助呢？這是我的第一個問題。接下來，我想從科學的角度解釋一下，為什麼高劑量會帶來更好的療效？ ——這只是為了讓我們更有信心。

Yes. I think that basically, a higher dose will simply -- the notion is extend the duration of action. That would be the primary thing that we're looking at. So obviously, it allows for longer duration of action because you will go longer until you achieve the minimally effective dose. So the notion is, can we show that we will now have increased numbers of patients who can do well with every 12-week dosing or every 16-week dosing. So that's the major goal of testing the higher dose.

是的。我認為，基本上來說，更高的劑量可以延長藥物的作用時間。這是我們主要關注的問題。顯然，較高的劑量可以延長藥物的作用時間，因為達到最低有效劑量所需的時間會更長。所以我們的目標是，能否證明每12週或每16週給藥一次，就能有更多患者獲得良好的療效。這就是測試更高劑量的主要目標。

Yes. And as George was saying that you're trying to extend the action. But if you look at an interval where in some patients, let's say, you take them in at every 8-week interval. There's still some people who are not completely dry because the drug probably isn't lasting the full 8 weeks even. And so you might see more drying as a manifestation of the longer action. So there are a couple of ways to slice it, but surely, you're looking to put more drug and have it last longer.

是的。正如喬治所說，你試圖延長藥效。但如果你觀察一下，比如說，對於某些患者，你每隔8週就帶他們回診一次。仍然有些人無法完全擺脫尿布疹，因為藥物可能甚至無法持續8週。因此，你可能會看到尿布疹更加嚴重，反而是藥效延長的表現。所以，這其中有很多解釋，但可以肯定的是，你的目標是增加藥物劑量並延長藥效。

Next question comes from Yaron Werber of Cowen.

下一個問題來自 Cowen 公司的 Yaron Werber。

Great. Marion, maybe for you on asthma. Can you give us a sense what's the share now for Dupi in asthma? And we understand that from physicians, (inaudible) has been very aggressive on pricing. What can you do to offset some of that growth in (inaudible)?

好的。瑪莉昂，也許你對氣喘治療比較了解。你能大概說說杜必利醇目前在氣喘治療領域的市佔率嗎？我們了解到，醫生（聽不清楚）在定價方面非常激進。你們有什麼辦法可以抵銷（聽不清楚）的部分成長？

Sure. Happy to take your question. First, I'll say, we're very pleased with the performance of Dupixent, both in terms of initiations and total scripts. We haven't given details of share by indications. So I'll stay away from that specificity today. But as you can see from our total performance and the data shared, we certainly are performing very, very well in the asthma marketplace.

當然可以。我很樂意回答您的問題。首先，我想說，我們對Dupixent的表現非常滿意，無論是在啟動治療數量還是處方總量方面。我們還沒有公佈按適應症劃分的市場份額詳情，所以今天我就不贅述了。但正如您從我們的整體業績和已公佈的數據中所看到的，我們在氣喘市場的表現確實非常出色。

I'm not going to comment on other companies' pricing strategies. But what I can say is when we look at the data comparing Dupixent uptake, either initiations or total scripts, it compares very favorably to the IL-5s. And we know that this is a result of the clinical profile, the safety profile and the value that not only pulmonologists, but also allergists are seeing in Dupixent for asthma. And as you know, with allergists also treating patients with concomitant diseases.

我不打算評論其他公司的定價策略。但我可以肯定的是，當我們比較Dupixent的使用數據時，無論是初始用藥量還是總處方量，它都比IL-5抑制劑更具優勢。我們知道，這得益於Dupixent的臨床療效、安全性以及其在氣喘治療方面的價值，不僅肺科醫生，過敏科醫生也認可它。如您所知，過敏科醫師也經常治療伴隨其他疾病的患者。

Next question comes from Kennen MacKay of RBC market.

下一個問題來自加拿大皇家銀行市場的 Kennen MacKay。

One on Dupixent, maybe also for Marion. It seems like Dupi is growing much faster in asthma than in AD. But it just seems like that's because derm has such a larger sales basis. So Marion, just wondering if you can frame what percent of Dupixent's quarter-over-quarter growth is coming from asthma versus derm?

關於Dupixent，可能也想問Marion。 Dupixent在氣喘領域的成長速度似乎比在異位性皮膚炎領域快得多。但這似乎只是因為皮膚科的銷售基數較大。所以Marion，我想問一下，Dupixent季度環比增長中，氣喘和皮膚科分別佔多大比例？

Sure. So let me talk about the total indications that I can share with you is that the dermatology, atopic dermatitis business in Dupixent is about 75%. About 25% in respiratory disease, both asthma and nasal polyps, asthma, of course, being the larger of the 2 in respiratory disease. Both are growing very, very strongly. And remember that we launched in atopic dermatitis several years before we did in the asthma marketplace, both are growing very, very strongly.

當然。我可以和大家分享的是，Dupixent 的整體市場表現中，約有 75% 來自皮膚科，尤其是異位性皮膚炎領域。約 25% 來自呼吸系統疾病領域，包括氣喘和鼻息肉，當然，氣喘在呼吸系統疾病領域佔更大。這兩個領域都成長非常強勁。請記住，我們在異位性皮膚炎領域比氣喘領域早幾年推出產品，這兩個領域目前都發展迅速。

And certainly, as we look at the future potential for Dupixent in atopic dermatitis, we have a long way to go. There's still tremendous unmet need across all age groups, the youngest patients, adolescents and adults. And then the asthma marketplace as well. It's important to note that today, about 75% of the patients in asthma going on Dupixent are biologic naive. So we're getting these new starts.

當然，展望Dupixent在異位性皮膚炎治療領域的未來潛力，我們還有很長的路要走。各個年齡層的患者，包括兒童、青少年和成人，都存在著巨大的未滿足需求。氣喘市場也是如此。值得注意的是，目前約有75%的氣喘患者在使用Dupixent治療前未接受過生物製劑治療。因此，我們正在迎來這些新的治療起點。

There's tremendous opportunity and Dupixent has been one of the growers of the overall asthma biologics marketplace. As mentioned in the -- in response to the earlier question, we look forward to, with an FDA approval, to launch in pediatrics later this year, but among adults and adolescents there's still tremendous opportunity in asthma as well. Both are growth engines for the product. And this is without even the many indications I look forward to launching in the future related to Type 2 disease, like Eosinophilic esophagitis and some of the other areas in allergy that George mentioned in his update today.

市場蘊藏著巨大的機遇，而Dupixent一直是整個氣喘生物製劑市場成長最快的產品之一。如同先前回答問題時所提到的，我們期待在獲得FDA批准後，於今年稍晚在兒科市場推出該產品，但成人和青少年氣喘市場也同樣擁有巨大的發展潛力。這兩個群體都是該產品的成長引擎。此外，我還期待未來推出與2型氣喘相關的多種適應症，例如嗜酸性粒細胞性食道炎，以及George在今天更新中提到的其他一些過敏性疾病領域。

Mary, we have time for 2 more questions. We're going to try to squeeze them in quickly.

瑪麗，我們還有時間再問兩個問題。我們會盡量抓緊時間問完。

Next question comes from Brian Skorney of Baird.

下一個問題來自 Baird 公司的 Brian Skorney。

This is Lea Lough dialing in for Brian Skorney. Our question is based on your partnership with Intellia. I see that we are anticipating the first in-vivo CRISPR data pretty soon. And we've seen good success here with the ex-vivo approach. Maybe you can share your thoughts on the in-vivo approach and how we should think about it in terms of looking at the safety of this approach. And not just for the ATTR indication, but more broadly for the proof-of-concept for this space?

這裡是Lea Lough，我代Brian Skorney連線。我們的問題是關於您與Intellia的合作。我了解到，我們預計很快就能獲得首個體內CRISPR數據。而且，我們在體外實驗方面也取得了不錯的成果。您能否分享一下您對體內實驗的看法，以及我們該如何看待這種方法的安全性？這不僅關乎ATTR適應症，更廣泛地說，關乎該領域概念驗證的安全性。

George, do you want to take that?

喬治，你想拿嗎？

Yes. I think that is the most important aspect of this for us is this is a platform. And as we've said, we have multiple targets that might be amenable to this platform that we've already identified through our Regeneron Genetics Center. And so of great interest will be, does it work. And what will be the safety and the tolerability profile. So we think that this will be a platform determining sort of results depending on how it turns out.

是的。我認為對我們來說，最重要的方面在於這是一個平台。正如我們所說，我們已經透過再生元遺傳學中心確定了多個可能適用於該平台的標靶。因此，我們非常關注的是，它是否有效，以及其安全性和耐受性如何。我們認為，這個平台最終的結果將決定我們未來的發展方向。

We have time for one more question.

我們還有時間回答最後一個問題。

Next question comes from Carter Gould of Barclays.

下一個問題來自巴克萊銀行的卡特·古爾德。

Great. Congratulations on the quarter and thanks for all the progress in tackling COVID. As you think -- how should we think about -- how do you think about appropriate REGEN-COV-2 production in an increasingly sort of post vaccination world? And any read into how countries the health care systems are approaching supply and stockpiling? And I guess in answering that question, can you just clarify kind of where you and Roche stand in terms of capacity in the efficacy of lower doses and continued improvements in efficiency and scale?

太好了。恭喜你們本季業績出色，也感謝你們在對抗新冠疫情方面取得的所有進展。您認為——或者說我們應該如何看待——在疫苗接種日益普及的後時代，如何才能合理地生產 REGEN-COV-2 疫苗？您能否談談各國醫療系統在供給和儲備方面的情況？我想在回答這個問題時，您能否簡要說明一下您和羅氏在低劑量疫苗的有效性、效率和規模的持續提升方面所處的產能狀況？

Len, you want to take that?

萊恩，你想拿那個嗎？

I don't think we're really in a position, it's better for Roche to comment on how the market is developing outside of the United States. But I do know that they're working on a lot of different discussions with a lot of different jurisdictions. And there is, as we speak now, adequate supply. But obviously, the pandemic changes pretty quickly. So I think Roche is probably going to be better positioned to answer that unless Justin has anything more specific for you.

我認為我們現在的情況不太適合就美國以外市場的發展發表評論，最好還是由羅氏公司來做。但我知道他們正在與許多不同的司法管轄區進行各種諮詢。而且就目前而言，供應充足。但顯然，疫情變化很快。所以，除非賈斯汀有更具體的訊息，否則我認為羅氏公司可能更適合回答這個問題。

No, that's it. Well, thank you for everyone joining the call today. We still have several callers in the queue that we didn't get to. We apologize for that. We will follow-up with you after the call. Thanks to everyone for dialing in. Be safe, and have a good day.

好了，就這些。感謝今天所有參與電話會議的朋友。我們還有一些排隊的來電者沒能一一接聽，對此我們深表歉意。會議結束後我們會與您聯繫。感謝大家的撥入。祝您平安，有美好的一天。

Thank you for your participation in today's conference call. This concludes the presentation. You may now disconnect. Good day.

感謝您參加今天的電話會議。本次示範到此結束，您可以斷開連線了。祝您今天愉快。