On February 16, 2022 Genmab A/S (Nasdaq: GMAB) reported the publication of its Annual Report for 2021 (Press release, Genmab, FEB 16, 2022, View Source [SID1234608179]). Below is a summary of business progress in 2021, financial performance for the year and the financial outlook for 2022 . The full report is attached as a PDF file and can be found in the investor section of the company’s website, www.genmab.com/investors.

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Conference Call
Genmab will hold a conference call in English to discuss the full year results for 2021 today, February 16, 2022 at 6:00 pm CET, 5:00 pm GMT or noon EST. To join the call dial +1 631 913 1422 (U.S. participants) or +44 3333 000804 (international participants) and provide conference code 76485840.

A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

2021 ACHIEVEMENTS

Business Progress
Bring our own medicines to patients

Tisotumab vedotin1 — U.S. FDA decision on BLA and progress to market — achieved
Tisotumab vedotin — Japanese New Drug Application (JNDA) submission in cervical cancer — potential JNDA filing timeline postponed to include Phase 3 innovaTV 301 data
Epcoritamab2 — acceleration & maximization of development program by advancing expansion cohorts and initiating additional Phase 3 trials — partial criteria was met for this goal in 2021, further progress is anticipated in 2022

Build world-class differentiated product pipeline

DuoBody-PD-L1x4-1BB3 — expansion cohort data — achieved
DuoBody-CD40x4-1BB3 — dose escalation data — achieved
Tisotumab vedotin — data in other tumor indication — achieved
Earlier stage products — progress & expand innovative product pipeline — partial criteria was met for this goal in 2021, further progress is anticipated in 2022
Become leading integrated innovation powerhouse

Operational commercialization model in US & Japan — achieved
Further strengthen solid financial foundation — achieved
Financial Performance

Net sales of DARZALEX by Janssen Biotech Inc. (Janssen) were USD 6,023 million in 2021 compared to USD 4,190 million in 2020, an increase of USD 1,833 million, or 44%.
Royalty revenue was DKK 6,977 million in 2021 compared to DKK 4,741 million in 2020, an increase of DKK 2,236 million, or 47%. The increase was driven by higher net sales of DARZALEX, TEPEZZA and Kesimpta resulting in higher royalties.
Total revenue was DKK 8,482 million in 2021. In addition to the royalty revenue described above, Genmab also recognized DKK 954 million of milestone revenue during 2021. Revenue in 2020 was DKK 10,111 million and included the one-time upfront payment of DKK 4,398 million recognized as license revenue from AbbVie Inc. (AbbVie) pursuant to our collaboration announced in June 2020.
Operating expenses were DKK 5,464 million in 2021 compared to DKK 3,798 million in 2020. The increase of DKK 1,666 million, or 44%, was driven by the continued advancement of multiple pipeline projects, the increase in new team members to support the launch of Tivdak and expansion of our product pipeline, as well as the continued development of commercialization capabilities and Genmab’s broader organizational infrastructure.
Operating profit was DKK 3,018 million in 2021 compared to DKK 6,313 million in 2020. The decrease of DKK 3,295 million, or 52%, was driven by lower revenue as a result of the non-recurring license revenue in 2020 associated with the upfront payment from AbbVie and increased operating expenses.

Revenue
Genmab expects its 2022 revenue to be in the range of DKK 10,800 – 12,000 million, compared to DKK 8,482 million in 2021. Our revenue in 2021 was driven primarily by the continued strong growth of DARZALEX net sales.

Genmab’s projected revenue for 2022 primarily consists of DARZALEX royalties of DKK 7,700 – 8,500 million. Such royalties are based on estimated DARZALEX 2022 net sales of USD 7.3 – 8.0 billion compared to actual net sales in 2021 of approximately USD 6.0 billion. Since the second quarter of 2020, Janssen has reduced its royalty payments to Genmab by what it claims to be Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. in connection with subcutaneous sales. Given the ongoing arbitration, Genmab has reflected this as a reduction to estimated 2022 revenue. The remainder of Genmab’s revenue consists of increasing royalties from TEPEZZA, Kesimpta and RYBREVANT, reimbursement revenue, milestones for epcoritamab, other milestones and collaboration revenue related to Tivdak commercialization efforts in the U.S. as part of our Seagen Inc. (Seagen) collaboration.

Operating Expenses
Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,200 – 7,800 million, compared to DKK 5,464 million in 2021. The increase is driven by the advancement of Genmab’s clinical programs, continued investment in research and development, as well as building Genmab’s commercial organization and broader organizational infrastructure.

Operating Profit
We expect our operating profit to be in the range of DKK 3,000 – 4,800 million in 2022, compared to DKK 3,018 million in 2021.

More information on the Risks and Assumptions for the 2022 Financial Guidance can be found in the 2021 Annual Report available on our website www.genmab.com/investors.

On February 16, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that it will host a conference call at 1:30 p.m. PST/4:30 p.m. EST on Thursday, March 3, following release of its fourth quarter and full year 2021 financial results (Press release, Puma Biotechnology, FEB 16, 2022, View Source [SID1234608195]).

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The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On February 16, 2022 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported its results for the fourth quarter and full year 2021 (Press release, BerGenBio, FEB 16, 2022, View Source [SID1234608161]).

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A briefing by BerGenBio’s senior management team will take place at 10:00am CET today via a webcast presentation, followed by a Q&A session. Please see below for details.

Operational Highlights – fourth quarter 2021 (including post-period end)• Post-period end, BerGenBio announced its participation in the EU-SolidAct trial, part of EU-RESPONSE, a pan-European research project involved with the rapid and coordinated investigation of medications to treat COVID-19 during the ongoing pandemic allowingBerGenBio to potentially confirm encouraging clinical data at significantly reduced cost​. • Licensed key exclusive intellectual property rights from UT Southwestern Medical Center, which strengthen the intellectual property estate for the potential treatment of Non-Small Cell Cancer (NSCLC) patients with STK11 mutations.• Granted Fast Track designation by the FDA for bemcentinib in combination with an anti-PD-(L)1 agents as treatment for patients with STK11 altered advanced/metastatic NSCLC patients without actionable mutations.• Presented pre-clinical and clinical data on bemcentinib in STK11 mutated NSCLC at SITC (Free SITC Whitepaper) Annual Meeting 2021, indication that bemcentinib restores response to anti-PD-1 treatments in NSCLC patients with STK11 mutations.• Presented updated data from Phase II trial(BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in older, relapsedand refractory AML patients at the 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting.• Anders Tullgren appointed as Chairman of the Board, bringing over 35 years of global experience in both large pharmaceutical and small/mid-size biotech environments.

Financial Highlights – fourth quarter and full year 2021(Figures in brackets = same period 2020 unless otherwise stated) • Revenue amounted to NOK 0.8 million (NOK 0.6million) for the fourth quarter and NOK 0.8million (NOK 0.6 million) for the full year 2021• Total operating expenses for the fourth quarter were NOK 68.1 million (NOK 72.4 million) and total operating expenses for the full year 2021amounted to 315.2 million (NOK 261.7 million)• The operating loss for the quarter came to NOK 67.3 million (NOK 71.8 million) and NOK 314.5 million (NOK 261.1 million) for the full year2021• Cash and cash equivalents amounted to NOK 436.4 million at the end of December 2021 (NOK 721.6 million by end of December 2020)

Martin Olin, Chief Executive Officer of BerGenBio, commented: "In the fourth quarter of 2021 we continued to make significant progress in defining our strategy and priorities to advance our two AXL development candidates. Our lead development candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor currently undergoing Phase II clinical trials in NSCLC, AMLand respiratory infections (COVID-19), is well positioned for further advancement.

"Our strategy and priorities going forward will be anchored within a rigorous data-driven framework, where the scientific rationale, pre-clinical and clinical data define a compelling rationale for advancing our development candidates towards potential treatment modalities addressing high unmet medical needs.

"With a clear strategy in place, I believe BerGenBio is well positioned to progress and deliver on its potential. I look forward to providing you with further updates on our progress."

Presentation and Webcast Details

The live webcast link is available at www.bergenbio.com in the Investors/Financial Reports section. A recording will be available shortly after the webcast has finished.

The fourth quarter and full year report and presentation will be made available on the Company’s website in the Investors/Financial Reports section and a recording of the webcast will be made available shortly after the webcast has finished.

On February 16, 2022 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that its Board of Directors approved a 7% increase in the Company’s quarterly dividend to $0.26 per share, or $1.04 per share on an annual basis, from $0.24 per share (Press release, Perrigo Company, FEB 16, 2022, View Source [SID1234608180]). This dividend increase marks the 19th consecutive year Perrigo has increased its dividend.

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The cash dividend is payable on March 17, 2022 to shareholders of record on February 28, 2022.

On February 16, 2022 Pebble Global Holdings (aka "Pebble Life Sciences" or "Pebble"), a privately held Texas-based leader in non-psychotropic cannabinoid research for drug development, reported that a sponsored research program entitled "Evaluation of Multi-Cannabinoid Formulations in Ovarian Cancer" was initiated in 2020 and presently exists between Pebble and MD Anderson Cancer Center ("MD Anderson") (Press release, MD Anderson, FEB 16, 2022, View Source [SID1234608196]). MD Anderson is one of the world’s most respected centers devoted exclusively to cancer patient care, education, prevention, research and ranked No. 1 in cancer in the U.S. News & World Report’s 2021-2022 annual "Best Hospitals."

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Despite being one of the most researched, ovarian cancer is the leading cause of gynecological cancer in the US and second most globally. It is the fifth leading cause of cancer death in US women, with 22,000 diagnosed in 2021, resulting in 14,000 deaths. 75% of patients are "advanced" at initial diagnosis, with 1 in 6 dying within 90 days and treatment limited by severe adverse effects from the current standard of care.

"Our team has thoroughly enjoyed working with MD Anderson the past two years on this novel therapy. We’re excited to continue with MD Anderson, to improve cancer treatment standard of care. Pebble’s non-THC, non-psychotropic approach permits a regulatory drug pathway that allows both domestic and global distribution, so we can help as many suffering women as possible," says Pebble Founder & CEO – Patrick Moran.