On April 26, 2022 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) reported that results for the first quarter of 2022 and increased the outlook for full-year 2022 (Press release, Qiagen, APR 26, 2022, View Source [SID1234612957]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Net sales for Q1 2022 rose 11% (+15% CER) from Q1 2021 to $628.4 million, ahead of the outlook for at least 7% CER growth. Sales were driven by 14% CER growth in the non-COVID-19 product portfolio and an 18% CER rise in sales of products used for COVID-19 testing and surveillance. Adjusted diluted earnings per share (EPS) rose to $0.80 ($0.83 CER) from $0.66 in Q1 2021, and above the outlook for at least $0.72 CER.

Based on the strong start to the year, QIAGEN has increased its full-year 2022 net sales outlook to at least $2.12 billion CER and for adjusted diluted EPS of at least $2.14 CER.

The updated outlook reflects a reaffirmation of the previous goal for double-digit CER sales growth from the non-COVID product groups, but for a significant year-on-year decline in COVID-19 product group sales based on the expected volatile pandemic trends in 2022. Also taken into consideration was an updated assessment of current inflation and macro-economic trends. This included the adverse impact of anticipated lost sales in 2022 from Russia, Ukraine and Belarus as a result of the war in Ukraine. These countries represented approximately 1% of total QIAGEN sales in 2021. QIAGEN continues to make ongoing investments into its portfolio, in particular the five pillars of growth, for new products, test menu and applications. This outlook does not take into consideration any future acquisitions.

"QIAGEN is off to a strong start in 2022, led by the solid performance of our non-COVID product portfolio in the first quarter driven by a focus on execution against our goals. These results have also reaffirmed our confidence in double-digit CER sales growth for 2022 from these products, which form the basis for our mid-term growth ambitions," said Thierry Bernard, Chief Executive Officer of QIAGEN N.V. "This performance in the first quarter has set a solid stage for continued execution in an increasingly volatile environment while our proactive initiatives have helped to build resilience into our business."

"Our teams of empowered QIAGENers are focused on delivering on our promises for future growth. We continue to execute, quarter after quarter, from sales goals to project development. We continue to develop a well-balanced portfolio between Life Science and Molecular Diagnostics customers, across our different regions, and also between our five pillars of growth and our core business." Bernard said.

Roland Sackers, Chief Financial Officer of QIAGEN N.V., said: "Our results for the first quarter of 2022 show the power of QIAGEN with strong sales growth, improved profitability and operating cash flow over the same period in 2021. We are confident that investments into our portfolio are creating value and positioning QIAGEN toward new growth waves in the coming years. We continue to review opportunities for capital deployment, including bolt-on acquisitions, that are aligned with our strategy and set to create greater value for shareholders and our other stakeholders."

Please find the full press release here.

Investor presentation and conference call

A conference call is planned for Thursday, April 28, 2022, at 16:00 Frankfurt Time / 15:00 London Time / 10:00 New York Time. A live audio webcast will be made available in the investor relations section of the QIAGEN website, and a replay will also be made available after the event. A presentation is planned to be available shortly before the conference call at View Source

On April 26, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it will report its first quarter 2022 financial results after market close on Tuesday, May 3, 2022 (Press release, Rigel, APR 26, 2022, View Source [SID1234612973]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call will also feature a presentation by Key Opinion Leader and FORWARD trial investigator, Caroline Piatek, M.D., Associate Professor of Clinical Medicine, Jane Anne Nohl Division of Hematology at the Keck School of Medicine of the University of Southern California. Dr. Piatek will discuss the current treatment landscape, unmet medical need, patient journey, and how she may incorporate fostamatinib, if approved, into clinical practice in warm autoimmune hemolytic anemia (wAIHA).

Dr. Piatek’s clinical focus is in non-malignant hematology. Her research interests include immune thrombocytopenia (ITP), wAIHA, cancer-associated thrombosis, and paroxysmal nocturnal hemoglobinuria.

Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

About the FORWARD Phase 3 Study
Fostamatinib is currently being evaluated in a Phase 3 randomized, double-blind, placebo-controlled clinical study in 90 patients with wAIHA who have failed at least one prior treatment. The study will evaluate the efficacy of fostamatinib versus placebo in achieving a durable hemoglobin response, defined as a hemoglobin level ≥ 10 g/dL, with an increase from baseline and durability measure in hemoglobin level of ≥ 2 g/dL, with the response not being attributed to rescue therapy, on three consecutive available visits during the 24-week treatment period. Secondary endpoints include other measures of hemoglobin response, use of rescue medication, and safety. The pivotal trial is fully enrolled and topline data is expected in mid-2022.

The FDA has granted fostamatinib Orphan Drug and Fast Track designations for the treatment of patients with wAIHA.

Fostamatinib, commercially available in the U.S. under the brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets, is the first and only FDA-approved SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.

On April 26, 2022 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, APR 26, 2022, View Source [SID1234612990]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bank of America Healthcare Conference on Tuesday, May 10 at 5:00pm ET

Bernstein’s Annual Strategic Decisions Conference on Thursday, June 2 at 4:30pm ET

Jefferies Global Healthcare Conference on Wednesday, June 8 at 11:00am ET

Goldman Sachs Global Healthcare Conference on Wednesday, June 15 at 2:20pm ET

The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

On April 26, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that its first quarter 2022 financial results will be released on Tuesday, May 10, 2022 after the markets close (Press release, Exelixis, APR 26, 2022, View Source [SID1234612958]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update . Access to the event is available via the Internet from the company’s website.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 6282616 to join by phone.

A telephone replay will be available until 8:00 p.m. ET on May 12, 2022. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 6282616. A webcast replay will also be archived on www.exelixis.com for one year.

On April 26, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the Company has launched a Pre-Approval Access/Expanded Access Program ("EAP") with SELLAS’ lead asset, GPS, for treating patients suffering from acute myeloid leukemia (AML) (Press release, Sellas Life Sciences, APR 26, 2022, View Source [SID1234612974]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

GPS is an immunotherapeutic that targets the Wilms Tumor 1 (WT1) protein. The Company is currently testing GPS as a monotherapy in a pivotal Phase 3 clinical trial (the REGAL trial) in patients with AML who have achieved second complete remission, as well as in combination with PD1 inhibitors in earlier stage clinical trials.

"After receiving multiple requests from physicians who have been following GPS and its results to date, it became clear, particularly under the 21st Century Cures Act, that we needed to initiate an EAP quickly to help patients around the world with AML, an aggressive form of cancer that progresses rapidly without the proper treatment," said Angelos Stergiou, MD, ScD. h.c., President and CEO, SELLAS. "SELLAS is firmly committed to its mission to improve clinical outcomes for these patients and their families who want to consider all possible therapeutic options, as well as ensuring that we are bringing a new, safe and potentially effective treatment option to physicians and patients in need."