On April 30, 2021 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that its first quarter 2021 financial results will be released after market close on Thursday, May 6, 2021. Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call and webcast to discuss financial results and provide a general business update (Press release, Coherus Biosciences, APR 30, 2021, View Source [SID1234578894]).

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!

After releasing first quarter financial results, the Company will post them on the Coherus website at View Source

Conference Call Information

Please dial-in 15 minutes early to ensure a timely connection to the call.

On April 30, 2021 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2021 (Press release, AbbVie, APR 30, 2021, View Source [SID1234578893]).

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!

"We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our new products are delivering impressive performance and we are on the cusp of potential commercial approvals for more than a dozen new products or indications over the next two years – including five expected approvals in 2021."

First-Quarter Results

Worldwide GAAP net revenues were $13.010 billion, an increase of 51.0 percent on a reported basis. Worldwide adjusted net revenues of $12.935 billion increased 5.2 percent on a comparable operational basis.
Global net revenues from the immunology portfolio were $5.744 billion, an increase of 12.9 percent on a reported basis, or 11.8 percent on an operational basis.
Global Humira net revenues of $4.867 billion increased 3.5 percent on a reported basis, or 2.6 percent on an operational basis. U.S. Humira net revenues were $3.907 billion, an increase of 6.9 percent. Internationally, Humira net revenues were $960 million, a decrease of 8.3 percent on a reported basis, or 12.6 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $574 million.
Global Rinvoq net revenues were $303 million.
Global net revenues from the hematologic oncology portfolio were $1.673 billion, an increase of 8.0 percent on a reported basis, or 7.3 percent on an operational basis.
Global Imbruvica net revenues were $1.268 billion, an increase of 2.9 percent, with U.S. net revenues of $999 million and international profit sharing of $269 million.
Global Venclexta net revenues were $405 million, an increase of 27.9 percent on a reported basis, or 24.5 percent on an operational basis.
Global net revenues from the aesthetics portfolio were $1.141 billion, an increase of 34.9 percent on a comparable operational basis.
Global Botox Cosmetic net revenues were $477 million, an increase of 44.7 percent on a comparable operational basis.
Global net revenues from the neuroscience portfolio were $1.248 billion, an increase of over 100.0 percent on a reported basis, or 10.9 percent on a comparable operational basis.
Global Botox Therapeutic net revenues were $532 million, an increase of 7.0 percent on a comparable operational basis.
Global Vraylar net revenues were $346 million, an increase of 21.2 percent on a comparable operational basis.
Global Ubrelvy net revenues were $81 million.
On a GAAP basis, the gross margin ratio in the first quarter was 67.6 percent. The adjusted gross margin ratio was 83.9 percent.
On a GAAP basis, selling, general and administrative expense was 21.8 percent of net revenues. The adjusted SG&A expense was 21.2 percent of net revenues.
On a GAAP basis, research and development expense was 13.7 percent of net revenues. The adjusted R&D expense was 11.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the first quarter was 31.5 percent. The adjusted operating margin was 51.0 percent.
On a GAAP basis, net interest expense was $622 million.
On a GAAP basis, the tax rate in the quarter was 8.1 percent. The adjusted tax rate was 12.3 percent.
Diluted EPS in the first quarter was $1.99 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.95.
Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). The applications are supported by two Phase 3 studies in which Skyrizi demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo. The safety profile of Skyrizi in these studies was generally consistent with the safety profile of Skyrizi in plaque psoriasis, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced positive results from the Phase 3 induction study, U-ACCOMPLISH, which showed Rinvoq (upadacitinib, 45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8 in adult patients with moderate to severe ulcerative colitis (UC). Additionally, all ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met. U-ACCOMPLISH is the second of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe UC and the results were consistent with findings from the first Phase 3 induction study, U-ACHIEVE. Safety results were also consistent with the previous Phase 3 induction study and the known profile of Rinvoq, with no new safety risks observed. Full results from the study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Results from the Phase 3 maintenance study and regulatory submissions are expected in 2H 2021.
AbbVie announced that the FDA extended the review period for the supplemental New Drug Applications (sNDA) for Rinvoq in the treatment of adult patients with active PsA as well as in the treatment of adults and adolescents with moderate to severe atopic dermatitis (AD). AbbVie received information requests from the FDA for an updated assessment of the benefit-risk profile for Rinvoq in both indications. AbbVie responded to the requests and the FDA will require additional time for a full review of the submissions. The updated Prescription Drug User Fee Act (PDUFA) action dates have been extended three months to late 2Q 2021 for PsA and early 3Q 2021 for AD.
AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion for Venclyxto (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is based on data from the VIALE-A and M14-358 trials and represents the third positive CHMP opinion for an extension of indications for Venclyxto. If approved by the European Commission (EC), Venclyxto in combination with hypomethylating agents would be a new regimen for patients with AML. The EC is expected to deliver its final decision on Venclyxto combination therapy for use in AML in 2Q 2021. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
AbbVie announced the FDA accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. The NDA is supported by data from a clinical program evaluating the efficacy, safety and tolerability of orally administered atogepant in nearly 2,500 patients who experience 4-14 migraine days per month, including data from the pivotal Phase 3 ADVANCE study in which all active treatment arms of atogepant met their primary endpoint and the 30 and 60 mg doses met all six secondary endpoints with statistical significance. If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. AbbVie anticipates a regulatory decision in late 3Q 2021.
At the 2021 American Academy of Neurology (AAN) Annual Meeting, AbbVie presented data across its neuroscience portfolio. A total of 33 abstracts, including 4 oral presentations, were shared from a broad range of studies across the spectrum of migraine, advanced Parkinson’s disease (PD) and spasticity. Researchers presented migraine related data from the Phase 3 ADVANCE trial results on the safety and efficacy of atogepant in the preventive treatment of migraine, real-world data on the role of Botox (onabotulinumtoxinA) in combination with CGRP monoclonal antibodies (mAbs) for chronic migraine prevention, as well as data evaluating the efficacy and safety of Botox and Ubrelvy (ubrogepant). In addition, investigators presented the study design of the Phase 3 study assessing the efficacy and safety of the investigational treatment ABBV-951 (foslevodopa/foscarbidopa), a levodopa/carbidopa prodrug administered as a 24-hour continuous subcutaneous infusion, in people with advanced PD.
AbbVie announced that it submitted a NDA to the FDA for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. Presbyopia is a common, progressive condition that reduces the aging eye’s ability to focus on near objects and affects nearly half of the adult U.S. population. The application is primarily based on data from two pivotal Phase 3 studies involving 750 patients. In both studies AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision without a loss of distance vision. If approved, AGN-190584 is expected to be the first eye drop to treat presbyopia and the FDA is expected to act on the NDA by the end of 2021.
AbbVie announced the launch of Refresh Digital lubricant eye drops, a new lubricant eye drop formulated to specifically relieve dryness and irritation that may occur from prolonged screen time. Refresh Digital features proprietary HydroCell technology that supports all three layers of the tear film to keep eyes hydrated.
Allergan Aesthetics announced the launch of SkinMedica Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. SkinMedica Neck Correct Cream was designed to prevent the early signs as well as treat the visible appearance of moderate to severe neck aging. It is clinically proven to firm and tighten the look of crepey skin, prevent and reduce the look of sagging, smooth deep lines and wrinkles and enhance skin tone evenness.
AbbVie and Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. Under the multi-year agreement, AbbVie will utilize Caribou’s next-generation Cas12a CRISPR hybrid RNA-DNA genome editing and cell therapy technologies to research and develop two new CAR-T cell therapies directed to targets specified by AbbVie.
Full-Year 2021 Outlook

AbbVie is raising its GAAP diluted EPS guidance for the full-year 2021 from $6.69 to $6.89 to $7.27 to $7.47. AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.32 to $12.52 to $12.37 to $12.57. The company’s 2021 adjusted diluted EPS guidance excludes $5.10 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our first-quarter performance. The call will be webcast through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.

Non-GAAP Financial Results

Financial results for 2021 and 2020 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie’s management believes non-GAAP financial measures provide useful information to investors regarding AbbVie’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company’s 2021 financial guidance is also being provided on both a reported and a non-GAAP basis.

On April 30, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported that it will be participating in the BofA Securities 2021 Virtual Health Care Conference (Press release, Certara, APR 30, 2021, View Source [SID1234578892]).

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!

William Feehery, CEO, and Andrew Schemick, CFO, are scheduled to present on Tuesday, May 11, 2021 at 2:45 p.m. ET. A live webcast will be available on Certara’s investor relations website at View Source and will be available for replay for 90 days thereafter.

On April 30, 2021 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported financial results for the first quarter of 2021 (Press release, Alexion, APR 30, 2021, View Source [SID1234578891]). Total revenues in the first quarter were $1,636.5 million, a 13 percent increase compared to the same period in 2020. The positive impact of foreign currency on total revenues year-over-year was less than 1 percent inclusive of hedging activities. On a GAAP basis, diluted EPS attributable to Alexion in the first quarter of 2021 was $2.86, a 14 percent increase versus the first quarter of 2020. Non-GAAP diluted EPS attributable to Alexion for the first quarter of 2021 was $3.52, a 9 percent increase versus the first quarter of 2020.

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!

"We are off to a strong start in 2021, with continued advancement of our LEAD-EXPAND-DIVERSIFY strategy to progress our commercial portfolio as well as our many development programs," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "I am so proud of our teams’ ongoing dedication and execution, which are further advancing our mission of delivering life-changing medicines to people with rare diseases and devastating conditions. We are well positioned to build on our success and momentum as the year progresses and once we become part of AstraZeneca."

First Quarter 2021 Financial Highlights

Net product sales were $1,635.7 million in the first quarter of 2021, compared to $1,444.6 million in the first quarter of 2020.
SOLIRIS net product sales were $1,027.6 million, compared to $1,022.9 million in the first quarter of 2020, representing a 0.5 percent increase.
ULTOMIRIS net product sales were $346.9 million, compared to $222.8 million in the first quarter of 2020, representing a 56 percent increase.
STRENSIQ net product sales were $197.5 million, compared to $172.2 million in the first quarter of 2020, representing a 15 percent increase.
KANUMA net product sales were $34.8 million, compared to $26.7 million in the first quarter of 2020, representing a 30 percent increase.
ANDEXXA/ONDEXXYA net product sales were $28.9 million in the first quarter of 2021.
GAAP cost of sales was $125.4 million, compared to $111.7 million in the first quarter of 2020. Non-GAAP cost of sales was $113.8 million, compared to $108.6 million in the first quarter of 2020.
GAAP R&D expense was $289.1 million, compared to $200.9 million in the first quarter of 2020. Non-GAAP R&D expense was $267.0 million, compared to $185.7 million in the first quarter of 2020.
GAAP SG&A expense was $342.9 million, compared to $319.9 million in the first quarter of 2020. Non-GAAP SG&A expense was $292.2 million, compared to $259.1 million in the first quarter of 2020.
GAAP income tax expense was $113.4 million, compared to income tax expense of $106.0 million in the first quarter of 2020. Non-GAAP income tax expense was $145.7 million, compared to income tax expense of $141.2 million in the first quarter of 2020.
GAAP diluted EPS attributable to Alexion was $2.86, compared to $2.50 in the first quarter of 2020. Non-GAAP diluted EPS attributable to Alexion was $3.52, compared to $3.22 in the first quarter of 2020.
Research and Development

PHASE 3/4

SOLIRIS – Guillain-Barre Syndrome (GBS): SOLIRIS in GBS has been granted SAKIGAKE designation by Japan’s Ministry of Health, Labour and Welfare (MHLW). In February 2021, Alexion initiated a Phase 3 study of SOLIRIS in GBS in Japan and dosing is underway.
ULTOMIRIS – 100 mg/mL: An application for approval of the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS is under review in Japan. This higher concentration formulation is designed to reduce infusion time by more than 60 percent to approximately 45 minutes.
ULTOMIRIS – Subcutaneous: The Phase 3 study of weekly subcutaneous (SC) ULTOMIRIS demonstrated PK-based non-inferiority versus intravenous ULTOMIRIS. Pending collection of 12-month safety and drug-device combination data, Alexion plans to file for approval in the U.S. for the ULTOMIRIS SC formulation and device combination in PNH and aHUS in the third quarter of 2021, and in the EU in the first quarter of 2022.
ULTOMIRIS – Paroxysmal Nocturnal Hemoglobinuria (PNH): The U.S. FDA granted priority review for ULTOMIRIS in children and adolescents with PNH and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 7, 2021.
ULTOMIRIS – gMG: Enrollment is complete in the Phase 3 study of ULTOMIRIS in adults with gMG. Study results are expected in the second half of 2021.
ULTOMIRIS – NMOSD: In March 2021, Alexion completed enrollment in the Phase 3 study of ULTOMIRIS in NMOSD.
ULTOMIRIS – Amyotrophic Lateral Sclerosis (ALS): In March 2021, Alexion completed enrollment in the Phase 3 study of ULTOMIRIS in ALS. Study results are expected in the first half of 2022.
ULTOMIRIS – Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA): Phase 3 studies of ULTOMIRIS in adults and children with HSCT-TMA are underway.
ULTOMIRIS – Complement Mediated Thrombotic Microangiopathy (CM-TMA): Alexion plans to initiate a Phase 3 study of ULTOMIRIS in CM-TMA in the second quarter of 2021.
ULTOMIRIS – Severe COVID-19: Further enrollment in a Phase 3 trial of ULTOMIRIS in adults hospitalized with severe COVID-19 requiring mechanical ventilation is paused, due to lack of efficacy, pending further analysis of the data. Alexion continues to provide ULTOMIRIS for the ongoing TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus.
ULTOMIRIS – Dermatomyositis (DM): Alexion plans to initiate a Phase 2/3 study of ULTOMIRIS in DM in the second half of 2021, pending regulatory feedback.
ALXN1840 – Wilson Disease: Enrollment and dosing are complete in a Phase 3 study of ALXN1840 in Wilson disease. Study results are expected in the third quarter of 2021.
CAEL-101 – Caelum Biosciences: Alexion and Caelum Biosciences are conducting the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care therapy in AL amyloidosis. Two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease – are underway.
ALXN2060 (AG10): Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Eidos is currently evaluating AG10 in two Phase 3 studies in the U.S. and Europe – one for ATTR cardiomyopathy (ATTR-CM) and one for ATTR polyneuropathy (ATTR-PN). Alexion is conducting a Phase 3 bridging study of ALXN2060 for patients with ATTR-CM in Japan.
ALXN2040 (Danicopan) – PNH with Extravascular Hemolysis (EVH): A Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH is underway.
ANDEXXA/ONDEXXYA – Acute Intracranial Hemorrhage (ICH): The Phase 4 ANNEXA-I study – designed to provide clinical data supporting full approval – is underway to assess ANDEXXA compared to usual standard of care in patients presenting with acute intracranial hemorrhage while taking an oral Factor Xa inhibitor. In addition, a supplemental Biologics License Application (sBLA) is under review by the U.S. FDA to enable the addition of edoxaban and enoxaparin to the U.S. label. In February 2021, Alexion filed for regulatory approval of ONDEXXYA in Japan.
PHASE 1/2

ULTOMIRIS – Renal Diseases: A proof-of-concept study of ULTOMIRIS in patients with IgA nephropathy and lupus nephritis is underway.
ALXN1830: Due to COVID-19, Alexion discontinued the Phase 2 study of ALXN1830, administered intravenously, in warm autoimmune hemolytic anemia (WAIHA) and the Phase 1 study of a subcutaneous formulation of ALXN1830 in healthy volunteers. In March 2021, Alexion initiated a new Phase 1 study of subcutaneous ALXN1830 in healthy volunteers. Following successful completion of this Phase 1 study, Alexion plans to initiate Phase 2 studies of subcutaneous ALXN1830 in gMG and WAIHA in 2021, pending regulatory feedback.
ALXN2040 – Geographic Atrophy (GA): In March 2021, Alexion submitted an Investigational New Drug (IND) application for ALXN2040 in GA and plans to initiate a Phase 2 study in the second half of 2021.
ALXN2040 – COVID-19: Alexion has agreed to provide ALXN2040 to the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the ACTIV-5 Big Effect Trial in adults hospitalized with COVID-19. This Phase 2 platform trial is comparing different investigational therapies to a common control arm with the intent of identifying promising treatments to enter a more definitive study.
ALXN2050 – PNH: Alexion has re-initiated additional enrollment in the Phase 2 study of ALXN2050 monotherapy in PNH patients, following the receipt of Phase 1 data that support further dose escalation in the Phase 2 study.
ALXN2050 – Renal Diseases: Alexion plans to initiate a proof-of-concept study of ALXN2050 in patients with various renal diseases in 2021, pending regulatory feedback.
ALXN1720: The Phase 1 healthy volunteer study of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that is designed to bind and prevent activation of human C5, has been paused for a second time due to COVID-19, but is expected to resume in the second quarter of 2021. Additional cohorts have been added to the study to explore higher doses and enable the initiation of a Phase 3 study in gMG, pending successful completion of the Phase 1 study as has been agreed with the U.S. FDA. Data from the Phase 1 study are expected in the second half of 2021. Alexion also plans to initiate a study of ALXN1720 in DM.
ANDEXXA – Urgent Surgery: ANDEXXA is currently being evaluated in a single-arm, open-label Phase 2 study in patients taking apixaban, rivaroxaban, edoxaban, or enoxaparin who require urgent surgery. The results of this study will inform the design of a randomized controlled Phase 3 clinical trial to expand the label in this population.
ALXN2075 (cerdulatinib): Acquired as part of the Portola acquisition, ALXN2075 is a dual spleen tyrosine kinase and janus kinase (SYK/JAK) inhibitor being evaluated in a Phase 1/2a study in patients with relapsed/refractory chronic lymphocytic leukemia or B-cell or T-cell non-Hodgkin lymphoma. Data are expected in the second quarter of 2021.
ALXN1820: A Phase 1 study of ALXN1820, Alexion’s bi-specific anti-properdin mini-body, is underway in healthy volunteers.
ALXN1850 – Hypophosphatasia (HPP): Alexion plans to initiate a Phase 1 study of ALXN1850 in adults with HPP in the second quarter of 2021, pending regulatory feedback.
COVID-19

We continue to take steps to proactively respond to the evolving COVID-19 pandemic and to plan for related uncertainties. We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinical trials. We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible.

Clinical Trials: We have implemented a pandemic response business continuity plan designed to protect patients and site staff safety while continuing our clinical trials with limited interruption to the extent we are able. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials and the majority of studies that had been temporarily paused due to the pandemic have resumed. A small number of clinical trial sites are restricting site visits and imposing restrictions on the initiation of new trials and patient visits to protect both site staff and patients from possible COVID-19 exposure. Based on local dynamics where these studies are being conducted, there has been, and may continue to be, an impact to the timing of trials that are enrolling patients and activating sites, or have not yet started to do so. We are actively implementing remote and local procedures under the guidance of regulatory authorities.
Business Impact: We continue to take proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients’ customary site-of-care locations. Treatment compliance rates across all our medicines have remained strong. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.
Conference Call/Earnings Materials:

Given the agreement for Alexion to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials are available publicly on the Investor Relations page of our website at View Source Questions may be directed to the Investor Relations team via e-mail at [email protected] or the contact information below.

On April 30, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that the Company’s first quarter 2021 financial results will be released on Thursday, May 6, 2021 (Press release, Calithera Biosciences, APR 30, 2021, View Source [SID1234578886]). Company management will host a conference call on Thursday, May 6, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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 press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 2073385. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.