On April 29, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company will be participating in the upcoming BofA Securities 2021 Healthcare Conference (Press release, Guardant Health, APR 29, 2021, View Source [SID1234578836]).

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Guardant Health’s management is scheduled to participate in a fireside chat on Wednesday, May 12 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. Interested parties may access a live and archived webcast of the presentation on the "Investors" section of the company website at: www.guardanthealth.com.

On April 29, 2021 WuXi AppTec Co., Ltd. (stock code: 603259.SH / 2359.HK), a company that provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients, reported its unaudited financial results for the First-Quarter of 2021 ("Reporting Period") (Press release, WuXi AppTec, APR 29, 2021, View Source [SID1234578851]).

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All financials disclosed in this press release are prepared based on International Financial Reporting Standards (or "IFRSs"), in currency of RMB.

[1] In the three months ended March 31, 2021 and three months ended March 31, 2020, we had a fully-diluted weighted average share count of 2,466,120,614 and 2,291,373,043 ordinary shares, respectively

First-Quarter 2021 Financial Highlights

Revenue soared 55.3% year-over-year to RMB4.95 billion on the back of robust demand brought on by strengthened customer market penetration and accelerated customer expansion. Revenue up 4.9% quarter-over-quarter continued our strong quarterly-based growth track record in the past twelve quarters. China-based laboratories and contract development and manufacturing organization (CDMO) facilities maintained high utilization to meet customer demands. Clinical research services experienced a strong rebound, but headwinds remain strong for US-based laboratory services which has continued to be negatively impacted by the COVID-19 pandemic.
– China-based laboratory services revenue grew 49.0% to RMB2.56 billion.
– CDMO services revenue grew 100.0% to RMB1.70 billion.
– U.S.-based laboratory services declined 15.3% to RMB329 million.
– Clinical research and other contract research organization (CRO) services revenue grew 56.8% to RMB359 million.

IFRS gross profit increased 67.6% year-over-year to RMB1.84 billion. Gross profit margin was 37.1% vs 34.4% in first-quarter 2020.[2]
Adjusted Non-IFRS gross profit increased 58.3% year-over-year to RMB1.94 billion. Adjusted Non-IFRS gross margin was 39.1% vs 38.4% in first-quarter 2020.
EBITDA increased 180.2% year-over-year to RMB2.09 billion.
Adjusted EBITDA increased 46.1% year-over-year to RMB1.51 billion.
Net profit attributable to owners of the Company increased 394.9% year-over-year to RMB1.50 billion. Our gain from venture investment portfolios and loss from associates totally contributed a net gain of RMB1.02 billion, due primarily to the stock price increase of certain listed companies and some portfolio companies successfully went IPO during the Reporting Period that led to an increase in their fair market value and an RMB4 million loss from our joint ventures. Conversely, in the first-quarter 2020, we reported a RMB171 million fair value loss from investment portfolios and associates, and a RMB7 million loss from our joint ventures.
Adjusted Non-IFRS net profit attributable to owners of the Company increased 63.6% year-over-year to RMB943 million.
Diluted EPS increased 369.2% year-over-year to RMB0.61, while adjusted diluted non-IFRS EPS increased by 52.0% year-over-year to RMB0.38.
[2] If prepared under Accounting Standard for Business Enterprises of PRC, 2021 the gross profit grew 67.2% year-over-year to RMB1.84 billion. Gross profit margin was 37.1%.

First-Quarter 2021 Business Highlights

We continued to relentlessly execute our strategy of enabling customers to innovate and accelerate drug discovery and development by leveraging our global integrated R&D services platform. We added over 360 new customers in the first-quarter of 2021, giving us a total of more than 4,400 active customers.
– Our global platform continued to enable innovation worldwide. During the Reporting Period, our overseas customers contributed RMB3.62 billion in revenues, increasing 49.5% year-over-year. Our China-based customers contributed RMB1.33 billion in revenues, increasing 73.9% year-over-year.
– We continued to expand our customer base and retain existing customers. During the Reporting Period, our existing customers contributed RMB4.75 billion in revenue, representing a year-over-year growth of 54.3%. Our newly added customers in the first-quarter of 2021 contributed RMB197 million in revenue.
– We aim to simultaneously increase service penetration in large global pharmaceutical companies, whilst increasing the size of our "long-tail" customer base. This strategy has continued to be successful. During the Reporting Period, the top 20 global pharmaceutical companies contributed RMB1.58 billion in revenue, increasing 66.6% year-over-year. Our "long-tail" and other customers contributed RMB3.37 billion in revenue, growing 50.5% year-over-year.
– We continued to increase customer conversion and deliver synergies across our entire platform. During the Reporting Period, customers using services from more than one of our business units contributed RMB3.94 billion in revenue, growing 58.4% year-over-year.

China-Based Laboratory Services: robust growth in all business lines on the back of strengthened customer market penetration and expansion

Chemistry FFS (Fee for Services) achieved over 58% revenue growth while concurrently transferring multiple new projects to our CDMO segment.
Through comprehensive integration of our DNA-encoded library (DEL), protein production and structure-based drug design capabilities, our Target-to-Hit platform(HitS) has enabled over 600 customers globally, and diverted multiple, incremental business opportunities to our downstream business units.
As of March 31, 2021, our success-based drug discovery service unit had cumulatively submitted 120 IND filings with the National Medical Products Administration (NMPA) and obtained 91 Clinical Trial Applications (CTAs) and had two projects in Phase III clinical trials.
Safety assessment / toxicology services revenue grew rapidly at approximately 114% due to strong demand and increased animal room capacity.
We signed over 40 integrated WIND packages (the WuXi IND program or "WIND") in the first-quarter of 2021.
CDMO Services: first-quarter 2021 growth doubled due to core business model execution and capacity increase

We added 169 new molecules into our small molecule CDMO pipeline, including 11 new projects that were transferred from clients’ facilities or other CDMOs. We provided CDMO services to over 1,340 active projects, including 46 projects in Phase III clinical trials and 28 projects in commercial manufacturing.

In the first-quarter 2021, new construction at Taixing city has begun and will provide a large scale API and oligonucleotide and peptide API production once complete. Taixing site is designed to provide over 140,000 square meters of manufacturing space in 2022.
The drug product manufacturing facility in Wuxi city slated to begin operation in 2021 will not only improve the development and production capacity of solid dosages, but will also be capable of sterile drug product development, clinical trial material production and commercial scale manufacturing.
The high-potency API manufacturing facility, large-scale oligonucleotide API manufacturing facility and large-scale peptide API manufacturing facility located in Changzhou city began operations, supporting process R&D and small molecule manufacturing, as well as oligonucleotide and peptide APIs from preclinical to commercial.
US-based Laboratory Services: Continued development of a comprehensive US-based cell and gene therapy CTDMO platform, with the integration of OXGENE

Our cell and gene therapy Contract Testing Development and Manufacturing Organization (CTDMO) services enabled customers globally. During the Reporting Period:

– Our laboratories and facilities in the U.S. provided services for 36 clinical stage projects, including 22 projects in Phase I clinical trials and 14 projects in Phase II/III clinical trials.
– The current quarter revenue decline in our U.S. cell and gene therapy business was mainly due to delay in approval of commercial projects and impacted by the pandemic. Some late stage/commercial clients also did not pass clinical trials; however, we are building up our new projects pipeline through significantly enhanced viral vector platforms and through integration with the newly acquired new OXGENE platforms. We expect strong rebound in revenue growth in the second half of 2021.
– In our Medical Device Testing business, the impact of the pandemic continued first-quarter. The delay of elective/non-essential surgeries impacted key projects caused shortfall of the testing demand. We are actively working and supplementing with new opportunities, particularly the EU Medical Device Regulation (MDR) to grow the medical device testing business in the second half of 2021.

Clinical Research CRO/SMO Services: strong rebound in revenue driven by focused backlog execution and timely project delivery

Our clinical research services continued to enable customers globally during the Reporting Period:
– Clinical development services (CDS) backlog increased approximately 56% on a year-over-year basis and our site management organization (SMO) backlog increased approximately 47% on a year-over-year basis.
– China based clinical research services[3] delivered strong growth in the first-quarter, at 64.7% year over year, while US based clinical trial services continued to suffer from the impact of the pandemic impact.
– CDS team provided services to more than 130 projects for our clients in China and the U.S. and completed registration trials for 3 products.
– Our SMO team maintained its No.1 leadership position in China, with more than 3,500 clinical research coordinators stationed in 150 cities providing services in ~1,000 hospitals. The team assisted in the market approval of 5 customer products that were approved by NMPA in the first quarter in 2021.

[3] China based clinical research services included CDS China and SMO businesses.

Management Comments

Dr. Ge Li, Chairman and CEO of WuXi AppTec, said, "Another record quarter has once again demonstrated the strength and resilience of our platform. We continue to flawlessly execute our business model, increasing customer penetration while increasing "long-tail" customer numbers with the highest quality of our service offerings. For CDMO, we are seeing benefits of aggressive investment in capacity and new modalities come to fruition with revenues doubling in the first-quarter. Our China-based laboratory services and clinical research services segments also out-performed, growing 49.0% and 56.8% respectively. We expect the upward trajectory of these business segments to continue, mitigating any continuing COVID-19 related challenges that U.S. based laboratory services may face."

"A continued strong biotech funding environment, coupled with incremental demand from the pandemic, reinforces our decision to further invest in and expand our integrated platform solidifying our leading position to meet strong and fast growing demands in 2021 and beyond."

Dr. Ge Li concluded, "This is a good start to 2021 and we anticipate this momentum to continue in the coming quarters. Going forward, we will continue to bolster our integrated business model by expanding our platform through investments in new modalities, further enabling our customers to bring the most innovative medicines to patients – fulfilling our vision that: ‘every drug can be made and every disease can be treated.’"

On April 29, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the first quarter ended March 31, 2021 on Thursday, May 6, 2021, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, APR 29, 2021, View Source [SID1234578896]). The announcement will be followed by a conference call and webcast with the investment community on Friday, May 7, 2021, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

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On April 29, 2021 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a conference call and webcast in conjunction with its first quarter 2021 update and financial results on Thursday, May 6 at 4:30 p.m. ET (View Source). To participate in the Webcast/Conference Call, please note there is a new pre-registration process.

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To register for the Webcast, use the link below:
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**When registering please type your phone number with no special characters**
Once you have registered, you will receive a confirmation email with Webcast/Conference Call details. For the Webcast you will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 7:30 p.m. ET on May 6, 2021 until 11:59 p.m. ET on June 3, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 2996776. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

On April 29, 2021 Seagen Inc. (Nasdaq:SGEN) reported financial results for the first quarter and three months ended March 31, 2021 (Press release, Seagen, APR 29, 2021, View Source [SID1234578758]). The Company also highlighted ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib) commercial and development accomplishments, as well as progress with its lead pipeline programs to treat cancer.

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"Year-over-year quarterly net product sales growth of 52 percent was driven by rapid adoption of our newest products, PADCEV and TUKYSA, in addition to strong sales of ADCETRIS. We continue to project 2021 total net product sales in our territories of approximately $1.3 billion," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "Looking ahead, we expect continued global progress across the portfolio. This includes TUKYSA launches in Europe following marketing authorizations received in the first quarter. In collaboration with Astellas we are pursuing several PADCEV marketing applications across the United States, Europe, Japan and Latin America. In addition, we are preparing for potential U.S. launch of a fourth drug following FDA acceptance of our tisotumab vedotin BLA submission with Priority Review. We are continuing to deliver cutting-edge innovation and medicines that make a meaningful difference in the lives of cancer patients."
COMMERCIAL PRODUCTS HIGHLIGHTS

PADCEV

Received European Medicines Agency (EMA) Acceptance of Marketing Authorization Application (MAA): In March 2021, Seagen and Astellas announced that the EMA accepted the PADCEV MAA for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. PADCEV will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use can shorten the MAA evaluation timeframe.

Received FDA Filing Acceptance of Two Supplemental Biologics License Applications (sBLAs): In April 2021, the FDA accepted two PADCEV sBLA submissions for review under the Real-Time Oncology Review pilot program. The applications were granted Priority Review with a target action date of August 17, 2021. The review of both applications will be conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. The first sBLA is based on the phase 3 EV-301 trial and seeks to convert PADCEV’s accelerated approval to regular approval. The second sBLA, based on the pivotal trial EV-201’s cohort 2, requests an expansion of the current indication to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

Submitted Several Additional Global Marketing Authorization Applications: In addition to the MAA under review in the European Union (EU), Seagen and Astellas have submitted applications for PADCEV approval in Australia, Canada, Japan, Singapore, Brazil and Switzerland.

Reported Positive EV-201 Cohort 2 and EV-301 Results in Patients with Previously Treated Advanced Urothelial Cancer: In February 2021, results were presented from the phase 3 EV-301 trial comparing PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The data showed significant improvements in overall and progression-free survival among patients treated with PADCEV compared to those who received chemotherapy. The findings were published in the New England Journal of Medicine and presented during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU). Data were also presented at ASCO (Free ASCO Whitepaper)-GU demonstrating durable tumor responses experienced among patients previously treated with immunotherapy in the second cohort of the pivotal EV-201 trial.
TUKYSA
Received Approval in the EU and Great Britain: In February 2021, TUKYSA was approved by the European Commission for use in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. The approval of TUKYSA is valid in all countries of the EU, as well as Norway, Liechtenstein, Iceland and Northern Ireland. In addition, TUKYSA was granted marketing authorization in Great Britain by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the same patient population. MHRA had previously granted TUKYSA a Promising Innovative Medicine designation.

Started Enrolling Multiple Clinical Trials: In the first quarter of 2021, the first patient was enrolled in two new clinical trials. The phase 3 CompassHER2 RD trial is evaluating TUKYSA in combination with Kadcyla (trastuzumab emtansine; T-DM1) compared to Kadcyla alone in the adjuvant HER2-positive breast cancer setting. The trial is being conducted by the Alliance for Clinical Trials in Oncology, a U.S. cooperative group. The second is a phase 2 trial evaluating TUKYSA in combination with trastuzumab in various metastatic solid tumors with HER2 alterations.

ADCETRIS

Expect Publication of 5-year Follow-up Results for ECHELON-1: The five-year update of the phase 3 ECHELON-1 clinical trial have been accepted for publication and should be published in the second quarter 2021. Data showed treatment with ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) resulted in superior long-term outcomes when compared to ABVD, which includes bleomycin, in frontline advanced Hodgkin lymphoma.

PIPELINE HIGHLIGHTS

Received FDA Filing Acceptance of Tisotumab Vedotin BLA for Priority Review: In April 2021, Seagen and Genmab announced the FDA had accepted for Priority Review the tisotumab vedotin BLA for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The FDA has set a target action date of October 10, 2021 submission is based on the results of the innovaTV 204 pivotal phase 2 trial, which were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 and published in The Lancet Oncology in April 2021.

Presented Data Highlighting Pipeline of Novel Targeted Therapies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: In April 2021, Seagen presented preclinical data on three pipeline programs that support the rationale for clinical development. SEA-TGT, an anti-TIGIT antibody using the Company’s sugar-engineered antibody (SEA) technology, and two vedotin-based ADCs, SGN-B6A and SGN-STNV, were highlighted. All of the programs are currently in phase 1 clinical trials.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

FIRST QUARTER 2021 FINANCIAL RESULTS

Revenues: Total revenues for the first quarter ended March 31, 2021 increased to $332.0 million, compared to $234.5 million for the same period in 2020. Growth over 2020 was driven by higher sales of PADCEV and the addition of TUKYSA to the Company’s commercial portfolio. Revenues are composed of the following three components:
Net Product Sales:

Three months ended March 31,
(dollars in millions)
2021

2020

% Change
Total Net Product Sales
$
302.6

$
198.5

52%
ADCETRIS
162.6

164.1

(1)%
PADCEV
69.8

34.5

102%
TUKYSA
70.3

—

N/A
Note: Sum of product sales may not equal total net product sales due to rounding.
Royalty Revenues: Royalty revenues for the first quarter in 2021 were $27.2 million, compared to $20.4 million for the same period in 2020. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, royalties from sales of Polivy (polatuzumab vedotin) by Roche and Blenrep (belantamab mafodotin) by GlaxoSmithKline, which are ADCs that use Seagen technology.

Collaboration and License Agreement Revenues: Amounts earned under the Company’s product, development and technology collaborations were $2.2 million in the first quarter in 2021, compared to $15.6 million for the same period in 2020. Collaboration revenues for the first quarter of 2020 included a regulatory milestone related to Polivy under the collaboration with Roche.

Cost of Sales: Cost of sales for the first quarter in 2021 were $64.1 million, compared to $29.4 million for the same period in 2020. The increase was primarily due to the gross profit share with Astellas based on PADCEV sales, which was $32.5 million in the first quarter of 2021, compared to $16.4 million for the same period in 2020. The increase in cost of sales also reflected amortization of acquired in-process technology costs that began with the approval of TUKYSA in April 2020, and third-party royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales, in addition to cost of products sold.

Research and Development (R&D) Expenses: R&D expenses for the first quarter in 2021 were $230.4 million, compared to $195.2 million for the same period in 2020. The increase in 2021 primarily reflected continued investment in the Company’s pipeline to evaluate new potential indications for the Company’s commercial drugs and to advance novel product candidates and technologies.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter in 2021 were $159.8 million, compared to $122.2 million for the same period in 2020. The increase was primarily attributed to increased field sales personnel and external spend to support our recently commercialized products, PADCEV and TUKYSA, and higher infrastructure costs to support our continued growth in the U.S. and Europe.
Non-cash, share-based compensation expense for the first three months of 2021 was $38.2 million, compared to $33.6 million for the same period in 2020.

Net Loss: Net loss for the first quarter of 2021 was $121.4 million, or $0.67 per diluted share, compared to net loss of $168.4 million, or $0.98 per diluted share, for the first quarter of 2020. Net loss in the first quarter of 2020 included a non-cash net investment loss of $59.1 million primarily associated with Seagen’s common stock holding in Immunomedics, which was marked-to-market.

Cash and Investments: As of March 31, 2021, Seagen had $2.5 billion in cash and investments.

2021 FINANCIAL OUTLOOK
Seagen anticipates 2021 revenues, operating expenses and other costs to be in the ranges shown in the table below, unchanged from the Company’s previous financial guidance provided on February 11, 2021.
Revenues
ADCETRIS net product sales
$675 million to $700 million
PADCEV net product sales
$310 million to $325 million
TUKYSA net product sales
$300 million to $315 million
Royalty revenues
$125 million to $135 million
Collaboration and license agreement revenues
Less than $20 million
Operating expenses and other costs
Cost of Sales
$270 million to $300 million
R&D expenses
$900 million to $1,000 million
SG&A expenses
$650 million to $725 million
Non-cash expenses1 (primarily attributable to
share-based compensation)
$225 million to $245 million
1. Non-cash expenses include share-based compensation, depreciation and amortization of intangible assets.
Conference Call Details
Seagen management will host a conference call and webcast with supporting slides to discuss its first quarter 2021 and year-to-date financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at www.seagen.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10153242. Supporting slides are available on the Seagen website at www.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website www.seagen.com, under the Investors section.