On May 1, 2020 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results for the first quarter ended March 31, 2020 and highlighted recent company events (Press release, GlycoMimetics, MAY 1, 2020, View Source [SID1234556898]). Cash and cash equivalents at March 31, 2020 were $154.8 million.

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"During the quarter, patient enrollment continued on track in GlycoMimetics’ Phase 3 registration program evaluating uproleselan in relapsed/refractory acute myeloid leukemia (AML) as well as in our collaboration with the National Cancer Institute (NCI) on a multi-center clinical trial evaluating the drug candidate in newly diagnosed patients fit for chemotherapy. Enrollment slowed in April as a result of the COVID-19 pandemic, and we continue to actively monitor the situation. At this time it is too early for us to comment on the potential impact of the pandemic on completion of enrollment in either trial, or the potential impact on cash burn. In addition, we are working closely with Apollomics in the Greater China region to initiate the Apollomics-funded third registration trial for uproleselan," commented Rachel King, Chief Executive Officer.

"In early April, Pfizer transferred to us the rivipansel investigational new drug application (IND) as well as the study data set from its Phase 3 clinical trial evaluating the drug’s clinical effect in sickle cell vaso-occlusive crisis," continued Ms. King. "We can now move forward to fully review the data to determine the next steps, if any, to take with respect to the rivipansel program now that we have worldwide development and commercialization rights."

Operational Highlights

Uproleselan

GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued to activate clinical sites and enroll patients in the U.S., Australia and Europe through March 2020.

The COVID-19 pandemic has resulted in slowed clinical site initiation, patient recruitment and enrollment rates beginning in April 2020, which we continue to closely monitor for any potential material impact on our expected completion of enrollment. Investigators continued to enroll patients in the NCI-sponsored Phase 3 clinical trial designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, through March 2020.

GlycoMimetics and Apollomics announced an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan (Greater China).

GMI-1359

Duke University initiated a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases, and investigators dosed the first patient in January of this year. The trial is evaluating safety and pharmacodynamic biomarkers in individuals with hormone receptor positive metastatic breast cancer.

A new composition of matter and formulation patent was issued in the United States for GMI-1359, and the U.S. Food and Drug Administration (FDA) granted orphan drug and rare pediatric disease designations for the drug candidate for the treatment of osteosarcoma that may provide future development support and marketing protections.

Rivipansel

GlycoMimetics and Pfizer worked closely to prepare for the transfer back to GlycoMimetics of the rivipansel program following Pfizer’s April 2020 termination of the parties’ 2011 license agreement for clinical development and commercialization of rivipansel in sickle cell disease (SCD). The transfer, now complete, includes the return of all rights and licenses previously granted, as well as the rivipansel IND and the Phase 3 RESET study data set.

GlycoMimetics is committed to a detailed assessment of what, if any, next steps to take with respect to the rivipansel program after reviewing the Phase 3 clinical data.

First Quarter 2020 Financial Results

Cash position: As of March 31, 2020, GlycoMimetics had cash and cash equivalents of $154.8 million as compared to $158.2 million as of December 31, 2019. In January 2020, GlycoMimetics received an upfront cash payment of $9.0 million from Apollomics pursuant to the exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Greater China.

R&D Expenses: The Company’s research and development expenses increased to $12.7 million for the quarter ended March 31, 2020 as compared to $ 11.8 million for the first quarter of 2019. Clinical development expenses increased by $2.4 million based on the higher clinical costs related to the Company’s ongoing Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase 3 clinical trial being conducted by the NCI. In addition, personnel-related and stock-based

compensation expenses increased by $540,000 due to annual performance adjustments processed in the quarter ended March 31, 2020. These increases were offset in part by a $2.1 million decrease in manufacturing and formulation due to lower raw material expenses in the first quarter ended March 31, 2020 as compared to the first quarter ended March 31, 2019.

G&A Expenses: The Company’s general and administrative expenses increased to $4.4 million for the quarter ended March 31, 2020 as compared to $3.4 million for the first quarter of 2019. Personnel-related expenses increased by $684,000 due to additional general and administrative headcount and annual salary adjustments awarded in the first quarter of 2020. Patent, legal fees, consulting and other professional expenses, including director and officer’s insurance premiums, increased by $373,000 for the quarter ended March 31, 2020 as compared to March 31, 2019.

Shares Outstanding: Shares of common stock outstanding as of March 31, 2020 were 43,582,979.

The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 4567397. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 4567397.

About Uproleselan and GMI-1687

Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.

GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 1,000-fold lower dose. GlycoMimetics believes that GMI-1687 could be developed as a potential life-cycle expansion to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. GMI-1687 is currently undergoing IND-enabling studies.

About GMI-1359

GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

On May 1, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported it will host a conference call to discuss the first quarter 2020 financial results and provide a corporate update on Thursday, May 7, 2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, MAY 1, 2020, View Source [SID1234556896]).

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Conference Call and Webcast:

Thursday, May 7, 2020 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 8470139

International: (973) 796-5077, Conference ID# 8470139

The conference call will also be available from the Investor Relations section of the company’s website at View Source and will be archived there shortly after the live event.

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 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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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

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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.