On May 1, 2020 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2020 (Press release, AbbVie, MAY 1, 2020, View Source [SID1234556895]).

"During this challenging time, we are doing everything possible to ensure our employees remain safe, our patients receive their medicines and assistance is available to help those most deeply impacted by the COVID-19 pandemic," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our business continues to perform well and remains strong, which speaks volumes as to the robustness of our portfolio and the commitment from our many dedicated employees across the organization."

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Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. 1

First-Quarter Results

Worldwide net revenues were $8.619 billion, an increase of 10.1 percent on a reported basis, or 10.7 percent operationally, including a 240 basis point stocking benefit related to the COVID-19 pandemic.

Global HUMIRA net revenues of $4.703 billion increased 5.8 percent on a reported basis, or 6.4 percent operationally. U.S. HUMIRA net revenues were $3.656 billion, an increase of 13.7 percent. Internationally, HUMIRA net revenues were $1.047 billion, a decrease of 14.9 percent on a reported basis, or 12.8 percent operationally, due to biosimilar competition.

Global net revenues from the hematologic oncology portfolio were $1.549 billion, an increase of 32.1 percent on a reported basis, or 32.3 percent operationally. Global IMBRUVICA net revenues were $1.232 billion, an increase of 20.6 percent, with U.S. net revenues of $966 million and international profit sharing of $266 million. Global VENCLEXTA net revenues were $317 million.

Global SKYRIZI net revenues were $300 million and global RINVOQ net revenues were $86 million.

On a GAAP basis, the gross margin ratio in the first quarter was 77.5 percent. The adjusted gross margin ratio was 82.7 percent.

On a GAAP basis, selling, general and administrative expense was 19.7 percent of net revenues. The adjusted SG&A expense was 18.6 percent of net revenues.

On a GAAP basis, research and development expense was 16.0 percent of net revenues. The adjusted R&D expense was 14.3 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 41.8 percent. The adjusted operating margin was 49.8 percent.

On a GAAP basis, net interest expense was $428 million. The adjusted net interest expense was $284 million.

On a GAAP basis, the tax rate in the quarter was 2.8 percent. The adjusted tax rate was 9.7 percent.

Diluted EPS in the first quarter was $2.02 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.42, including a $0.09 stocking benefit related to the COVID-19 pandemic.

Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. 2

Recent Events

AbbVie announced a donation of $35 million to support COVID-19 relief efforts with partners International Medical Corps, Direct Relief and Feeding America. In the U.S., AbbVie’s funds will be used to support healthcare capacity for hospitals as well as protect vulnerable populations by enabling access to food and essential supplies. In Europe, the donation will provide critical equipment and supplies to patients and front-line healthcare workers in the hardest-hit countries. Additionally, AbbVie is doubling the AbbVie Foundation match for COVID-19-related contributions by its employees, whereby the AbbVie Foundation will match $2 to every $1 employees donate to a nonprofit for this purpose.

AbbVie is supporting COVID-19 clinical research by collaborating with health authorities and institutions globally to determine antiviral activity as well as efficacy and safety of KALETRA/ALUVIA (lopinavir/ritonavir), AbbVie’s antiretroviral therapy for the treatment of HIV, against COVID-19. Collaboration partners include European health authorities and the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention, National Institutes of Health and Biomedical Advanced Research and Development Authority. Along with industry partners, the company has joined the Innovative Medicines Initiative to support research and discovery of targeted medicines against COVID-19.

AbbVie has initiated the Phase 2 iNSPIRE clinical trial to evaluate the potential of IMBRUVICA (ibrutinib) to treat patients with moderate to severe COVID-19. The trial will evaluate the role of IMBRUVICA in preventing pro-inflammatory cytokines through multiple pathways and reducing the risk of pulmonary failure, the most common cause of mortality related to COVID-19 infection. The study aims to determine the safety and efficacy of adding IMBRUVICA to best supportive care in treating patients with COVID-19 pulmonary distress.

AbbVie announced it received final approval from the European Commission (EC) and has entered into a consent decree agreement with staff of the U.S. Federal Trade Commission (FTC) regarding AbbVie’s pending acquisition of Allergan. The consent decree remains subject to further review and approval by the Commissioners of the FTC. AbbVie and Allergan anticipate deal closing in May 2020.

AbbVie announced the FDA approval of IMBRUVICA in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The approval is based on positive results from the landmark Phase 3 E1912 study, in which IMBRUVICA plus rituximab demonstrated superior progression free survival (PFS) against the chemoimmunotherapy regimen of fludarabine, cyclophosphamide and rituximab (FCR) for previously untreated patients with CLL. This milestone marks the 11th FDA approval for IMBRUVICA since it was first approved in 2013 and the sixth in CLL. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.

AbbVie announced that the EC has approved VENCLYXTO (venetoclax) in combination with obinutuzumab for the treatment of adult patients with CLL who were previously untreated. VENCLYXTO plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by the EC for patients with previously untreated CLL. Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLYXTO had superior PFS and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil. 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.

Recent Events (continued)

AbbVie announced results from two Phase 3 studies (VIALE-A and VIALE-C) for VENCLEXTA (venetoclax) in patients with previously-untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The VIALE-A trial, which evaluated VENCLEXTA in combination with azacitidine versus azacitidine plus placebo, met its dual primary endpoints of overall survival (OS) and composite complete remission rate. The VIALE-A study was stopped early due to positive efficacy results at the first interim analysis for OS. The VIALE-C trial, which evaluated VENCLEXTA in combination with low-dose cytarabine (LDAC) versus LDAC plus placebo, did not demonstrate statistically significant improvement in the primary endpoint of OS, but results were indicative of clinical activity of VENCLEXTA in combination with LDAC. In November 2018, AbbVie received accelerated approval in the U.S. for VENCLEXTA in combination with azacitidine, decitabine, or LDAC for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy based on the Phase 1/2 studies. The results of VIALE-A and VIALE-C will be provided to the FDA and submitted for regulatory approval by other global health authorities later this year.

AbbVie announced that the EC has approved a change to the marketing authorization for MAVIRET (glecaprevir/pibrentasvir) to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection. The decision makes MAVIRET the only pan-genotypic (GTs 1-6) 8-week treatment option for treatment-naïve, chronic HCV patients, without cirrhosis or with compensated cirrhosis. The approval is supported by data from the Phase 3b EXPEDITION-8 study, which showed that with 8 weeks of MAVIRET, an overall 98 percent patients achieved a sustained virologic response 12 weeks after treatment (SVR12), and for patients with GT3, the SVR12 rate was over 95 percent.

Full-Year 2020 Outlook
AbbVie is updating its standalone GAAP diluted EPS guidance for the full-year 2020 from $7.66 to $7.76 to $7.60 to $7.70, representing growth of 44.9 percent at the midpoint. AbbVie is confirming the previous expectation to deliver standalone adjusted diluted EPS for the full-year 2020 of $9.61 to $9.71, representing growth of 8.1 percent at the midpoint. The company’s standalone 2020 adjusted diluted EPS guidance excludes $2.01 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.
Statements Required by the Irish Takeover Rules

The directors of AbbVie accept responsibility for the information contained in this announcement. To the best of the knowledge and belief of the directors of AbbVie (who have taken all reasonable care to ensure that such is the case), the information contained in this announcement is in accordance with the facts and does not omit anything likely to affect the import of such information.

Any holder of 1 percent or more of any class of relevant securities of AbbVie Inc. may have disclosure obligations under Rule 8.3 of the Irish Takeover Panel Act, 1997, Takeover Rules 2013.

On May 1, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended March 31, 2020 (Press release, ImmunoGen, MAY 1, 2020, View Source [SID1234556891]).

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"During the last quarter, we moved forward with our registration studies for mirvetuximab and advanced our portfolio of earlier-stage candidates, while adapting to meet the evolving challenges of the COVID-19 pandemic," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Our lead program remains on track with the initiation of our pivotal SORAYA trial and patient enrollment in our confirmatory MIRASOL trial progressing as anticipated. In parallel, we continue to follow our FORWARD II combination cohorts and we are pleased to have initial data from our Avastin expansion cohort in platinum-agnostic ovarian cancer selected for a virtual oral presentation at ASCO (Free ASCO Whitepaper) in May. IND-enabling activities for IMGC936, our novel ADAM9-targeting ADC, continue on plan with an IND submission anticipated by the end of this quarter and we look forward to presenting pre-clinical data on IMGN151, our next generation anti-FRα ADC being investigated in tumors with a broad range of FRα expression, at the virtual AACR (Free AACR Whitepaper) Annual Meeting in June."

Enyedy added, "Having generated approximately $98M in net proceeds through a follow-on offering in January, we are in a strong financial position with our anticipated cash runway extended well into 2022. Drawing on the organizational resilience built over the last year, our team has risen to the challenge of COVID-19 to ensure that we can meet the needs of our patients around the globe. We have put in place business continuity plans to allow us to operate effectively in a virtual working environment, actively monitor our progress in our key studies, and rapidly adapt in response to new developments. Through these efforts, we seek to maintain the momentum we have generated in the business throughout 2020."

RECENT PROGRESS

Initiated SORAYA, a new single-arm study in platinum-resistant ovarian cancer for women previously treated with Avastin (bevacizumab), which is designed to support accelerated approval for mirvetuximab.

Continued to open sites and enroll patients in confirmatory Phase 3 MIRASOL trial.

Advanced multiple cohorts with IMGN632, including monotherapy expansion in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and minimal residual disease positive (MRD+) acute myeloid leukemeia (AML) following frontline induction therapy and combinations with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory AML patients.

Progressed investigational new drug (IND)-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.

Raised $97.7 million in net proceeds in a follow-on offering in January.

Activated business continuity plans in the context of COVID-19.

ANTICIPATED UPCOMING EVENTS

Continue patient enrollment in pivotal SORAYA and confirmatory MIRASOL trials.

Support initiation of an additional platinum-sensitive investigator sponsored trial evaluating mirvetuximab in combination with carboplatin in over 100 patients.

Present initial data from the FORWARD II platinum-agnostic doublet cohort evaluating mirvetuximab in combination with bevacizumab in an oral presentation at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in May.

Present pre-clinical data evaluating our next generation anti-folate receptor alpha (FRα) ADC, IMGN151, in ovarian cancer and other tumor types in a poster at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in June.

Present updated data from the FORWARD II platinum-sensitive triplet cohort evaluating mirvetuximab in combination with carboplatin and bevacizumab in the fall.

Continue enrollment in IMGN632 monotherapy and combination cohorts.

File IND for IMGC936 at the end of Q2.

Transition IMGN151 into pre-clinical development.

FINANCIAL RESULTS

Revenues for the quarter ended March 31, 2020 were $13.3 million, compared with $8.6 million for the quarter ended March 31, 2019, which consisted primarily of non-cash royalty revenues.

Operating expenses for the first quarter of 2020 were $37.1 million, compared with $50.2 million for the same quarter in 2019. The decrease was driven by R&D expenses, which were $27.4 million for the first quarter of 2020 compared with $38.9 million for the first quarter of 2019. This decrease was primarily due to lower expenses resulting from the restructuring of the business at the end of the second quarter of 2019, including decreases in personnel, facility, and third-party research expenses. Partially offsetting these decreases, clinical trial expenses increased in the current quarter driven by costs related to the Company’s MIRASOL, SORAYA, and IMGN632 combination therapy studies. General and administrative expenses for the first quarter of 2020 decreased to $8.9 million compared to $10.8 million for the first quarter of 2019 primarily due to lower personnel expenses resulting from the restructuring, partially offset by a higher allocation of facility-related expenses for excess laboratory and office space. Operating expenses for the first quarter of 2020 also included a $0.8 million restructuring charge related to retention costs, compared to a $0.6 million charge recorded in the first quarter of 2019 related to a loss recorded on leased office space.

Net loss for the first quarter of 2020 was $29.1 million, or $0.17 per basic and diluted share, compared to a net loss of $43.8 million, or $0.30 per basic and diluted share, for the first quarter of 2019. Weighted average shares outstanding increased to 166.9 million from 147.8 million in the prior year.

In January 2020, pursuant to a public offering, the Company sold an aggregate of 24.5 million shares of its common stock, with net proceeds to the Company of $97.7 million, after deducting underwriting discounts and offering expenses.

ImmunoGen had $247.3 million in cash and cash equivalents as of March 31, 2020, compared with $176.2 million as of December 31, 2019, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $(28.3) million for the quarter ended March 31, 2020, compared with cash provided by operations of $10.2 million for the quarter ended March 31, 2019. The prior year period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Net proceeds from the sale of equipment were $1.4 million for the first quarter of 2020 compared with capital expenditures of $(2.1) million for the first quarter of 2019.

FINANCIAL GUIDANCE

ImmunoGen’s financial guidance for 2020 remains unchanged:

revenues between $60 million and $65 million;
penses between $165 million and $170 million; and

cash and cash equivalents at December 31, 2020 to be between $170 million and $175 million.

ImmunoGen expects that its current cash and anticipated cash receipts from partners will fund operations into the second half of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial (877) 621-5803; the conference ID is 7796220. The call may also be accessed through the Investors and Media section of immunogen.com. Following the call, a replay will be available at the same location.

On May 1, 2020 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for CC-486, an investigational oral hypomethylating agent, for the maintenance treatment of adult patients with acute myeloid leukemia (AML), who achieved complete remission (CR) or CR with incomplete blood count recovery (CRi), following induction therapy with or without consolidation treatment, and who are not candidates for, or who choose not to proceed to, hematopoietic stem cell transplantation (Press release, Bristol-Myers Squibb, MAY 1, 2020, View Source [SID1234556888]). The FDA granted the application Priority Review and set a Prescription Drug User Fee Act (PDUFA) goal date of September 3, 2020.

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The NDA submission was based on the efficacy and safety results of the pivotal Phase 3 QUAZAR AML-001 study, which met the primary endpoint of improved overall survival for patients receiving AML maintenance treatment with CC-486 versus placebo.

"Often, newly diagnosed adult patients with AML achieve a complete response with induction therapy, however many patients will relapse and experience a poor outcome. Patients in remission are seeking treatment options that decrease the likelihood of relapse and extend overall survival," said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. "Today’s acceptance of our submission for CC-486 represents an important step towards a potential new maintenance treatment to address an urgent medical need for AML patients and we look forward to working with the FDA during its review of CC-486."

CC-486 is an investigational therapy that is not approved for any use in any country.

About CC-486

CC-486 is an oral hypomethylating agent that incorporates into DNA and RNA. The main mechanism of action is thought to be hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. Oral dosing of CC-486 allows for extended drug exposure during each treatment cycle to prolong therapeutic activity.1

About QUAZAR AML-001

QUAZAR AML-001 is a Phase 3, international, randomized, double-blind, placebo-controlled study of CC-486 as AML maintenance therapy in patients who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy (with or without consolidation), who were ineligible for hematopoietic stem cell transplant. The primary endpoint of the study was overall survival. Key secondary endpoints included relapse-free survival (RFS), safety and tolerability, healthcare resource utilization and patient-reported outcomes per the FACIT-Fatigue Scale and EQ-5D questionnaire. The study enrolled 472 patients, randomized 1:1 to receive initially either 300 mg of CC-486 or placebo orally, once daily, for 14 days of a 28-day cycle, plus best supportive care. Patients remained on treatment until unacceptable toxicity or disease progression.

About AML

Acute myeloid leukemia (AML) is the most common type of acute leukemia. AML starts in the bone marrow but moves quickly into the blood. Unlike in normal blood cell development, in AML, the rapid buildup of abnormal white blood cells in the bone marrow may interfere with the production of normal blood cells, resulting in decreased healthy white blood cells, red blood cells and platelets. AML is a complex, diverse disease associated with multiple genetic mutations and usually worsens quickly and can lead to death if not treated. AML has a high relapse rate, meaning following patients’ initial response to treatment, their disease is likely to return, signifying an unmet need for maintenance therapy options. There will be an estimated 21,450 new cases of AML in the United States this year, accounting for 1.2% of all cancer cases, with an estimated 10,920 deaths resulting from the disease. There are an estimated 61,048 people living with AML in the United States.

Bristol Myers Squibb: Advancing Oncology Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients’ quality of life, long-term survival and make cure a possibility. Through a unique multidisciplinary approach powered by translational science, we harness our deep scientific experience in oncology and Immuno-Oncology (I-O) research to identify novel treatments tailored to individual patient needs. Our researchers are developing a diverse, purposefully built pipeline designed to target different immune system pathways and address the complex and specific interactions between the tumor, its microenvironment and the immune system. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines, like I-O, a reality for patients.