On July 28, 2017 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent highlights and reported financial results for the quarter ended June 30, 2017 (Press release, ImmunoGen, JUL 28, 2017, View Source [SID1234519924]).

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"We made substantial progress during the second quarter towards our strategic priorities, generating compelling data with our lead program, advancing our novel pipeline, and strengthening our balance sheet," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "We reported single-agent and combination therapy data with mirvetuximab soravtansine in over 150 patients at ASCO (Free ASCO Whitepaper), which strengthen our confidence in the potential of mirvetuximab in the FORWARD I patient population and as we move into earlier lines of treatment for ovarian cancer. In addition, we presented encouraging initial clinical results for IMGN779 in AML, demonstrating dose-dependent biological and anti-leukemia activity, and the ability to retreat patients. Lastly, we significantly improved our cash position through transactions with Sanofi and Debiopharm, enabling us to increase our focus on the development of mirvetuximab and our IGN programs. We look forward to continued execution on these programs over the back half of the year, including filing the IND for IMGN632, our novel CD123-targeting ADC for hematological malignancies."

Recent Highlights

Proprietary Portfolio

Presented pooled analyses of three Phase 1 expansion cohorts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating the safety and efficacy profile of mirvetuximab soravtansine in the patient population being enrolled in FORWARD I, the ongoing Phase 3 registration trial in women with folate receptor alpha (FRα)-positive ovarian cancer;
Presented encouraging data from the Phase 1b/2 FORWARD II study at ASCO (Free ASCO Whitepaper), evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab), carboplatin, Doxil (pegylated liposomal doxorubicin), or Keytruda (pembrolizumab), demonstrating its potential to complement currently available therapies for FRα-positive ovarian cancer in a range of treatment settings, including earlier lines of therapy; and
Presented first-in-human data at the 22nd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) on IMGN779 in patients with relapsed or refractory adult acute myeloid leukemia (AML), whose tumors express CD33, demonstrating safety and tolerability across seven dose levels, with no dose limiting toxicities, as well as evidence of dose-dependent biological and anti-leukemia activity.
Partner Programs

In exchange for a $30 million payment, ImmunoGen granted sanofi-aventis U.S. LLC (Sanofi) a fully-paid, exclusive license to develop, manufacture, and commercialize the following experimental agents in development: isatuximab (SAR650984), an unconjugated anti-CD38 antibody in Phase 3 development for relapsed and refractory multiple myeloma; SAR566658, an ADC targeting CA6; SAR408701, an anti-CEACAM5 ADC; an additional ADC directed to an undisclosed target; and SAR428926, an ADC targeting LAMP1;
In exchange for a $25 million upfront payment, Debiopharm International, S.A. (Debiopharm) acquired the Company’s IMGN529/DEBIO 1562, a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphoma. ImmunoGen will receive a $5 million milestone payment upon completion of the transfer of technologies related to the asset, which is expected before year end, and is also eligible for a second success-based milestone payment of $25 million upon IMGN529/DEBIO 1562 entering a Phase 3 clinical trial;
CytomX announced the treatment of the first patient in a Phase 1/2 clinical trial evaluating CX-2009, a ProbodyTM drug conjugate, as monotherapy in select advanced solid tumors, resulting in a $1 million milestone payment to ImmunoGen; and
Bayer announced that the Phase 2 trial assessing anetumab ravtansine in patients with recurrent malignant pleural mesothelioma did not meet its primary endpoint of progression-free survival. The safety and tolerability of anetumab ravtansine were consistent with earlier clinical findings and Bayer is continuing development in additional studies, including a Phase 1b multi-indication study in six different types of advanced solid tumors, and a Phase 1b combination-study in patients with recurrent platinum-resistant ovarian cancer.
Additional Upcoming Events

ImmunoGen anticipates filing an investigational new drug (IND) application in the third quarter of 2017 to support clinical testing with IMGN632, a CD123-targeting ADC integrating a more potent DNA-alkylating payload intended to treat a range of hematological malignancies.
The Company expects to present updated clinical data for IMGN779 in patients with relapsed or refractory adult AML at an upcoming medical meeting.
ImmunoGen plans to publish results from the 40 patient Phase 1 mirvetuximab soravtansine expansion cohort evaluating the use of prophylactic steroid eye drops. The findings support the use of eye drops in the Phase 3 FORWARD I trial.
Financial Results

Revenues for the quarter ended June 30, 2017 were $39.0 million, compared to $7.4 million for the quarter ended June 30, 2016. License and milestone fees for the second quarter of 2017 included a $30 million paid-up license fee related to an amendment to the Company’s collaboration and license agreement with Sanofi and a $1 million Phase 1 milestone payment pursuant to the Company’s license agreement with CytomX. Revenues in the second quarter of 2017 included $6.4 million in non-cash royalty revenues, compared with $5.9 million in non-cash royalty revenues for the same quarter in 2016. Revenues for the second quarter of 2017 also included $0.9 million of research and development (R&D) support fees and $0.6 million of clinical materials revenue, compared with $1.3 million and $0.1 million, respectively, for the same quarter in 2016.

Operating expenses for the second quarter of 2017 were $44.2 million, compared to $48.0 million for the same quarter in 2016. Operating expenses in the second quarter of 2017 include R&D expenses of $35.3 million, compared to $38.7 million for the same quarter in 2016. This change is primarily due to a workforce reduction resulting from the strategic review in September 2016, decreased clinical trial costs driven by the Phase 1 mirvetuximab soravtansine and IMGN529 studies winding down, and lower third party costs. These decreases were partially offset by increased costs related to the FORWARD I Phase 3 clinical trial, as well as an increase in antibody expense driven by mirvetuximab soravtansine commercial-readiness activities. Operating expenses include general and administrative expenses of $8.8 million in the second quarter of 2017 compared to $9.3 million in the same quarter in 2016. This decrease is primarily due to decreased personnel expenses.

ImmunoGen reported a net loss of $8.9 million, or $0.10 per basic and diluted share, for the second quarter of 2017 compared to a net loss of $45.9 million, or $0.53 per basic and diluted share, for the same quarter last year.

ImmunoGen had approximately $150.3 million in cash and cash equivalents as of June 30, 2017, compared with $160.0 million as of December 31, 2016, and had $100.0 million of convertible debt outstanding in each period. Cash used in operations was $8.9 million for the first six months of 2017, compared with $59.0 million for the same period in 2016. The current period benefited from a $30 million paid-up license fee received from Sanofi, which is included in revenue in the current period, and a $25 million upfront payment received from Debiopharm that is included in deferred revenue as of June 30, 2017. Capital expenditures were $0.8 million and $5.2 million for the six months ended June 30, 2017 and 2016, respectively.

Financial Guidance

ImmunoGen has updated its guidance for 2017. Expected revenues are now projected to be between $115 million and $120 million, compared with previous guidance of between $70 million and $75 million; and cash and cash equivalents at December 31, 2017 are expected to be between $90 million and $95 million, compared to previous guidance of $35 million to $40 million. These changes are a result of the Debiopharm and Sanofi agreements executed in the second quarter of 2017. Operating expenses remain unchanged and are expected to be between $175 million and $180 million.

ImmunoGen expects that its current cash plus expected cash revenues from partners and collaborators will enable the Company to fund operations into the second half of 2018.

On July 28, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy (Press release, Hoffmann-La Roche, JUL 28, 2017, View Source [SID1234519919]). FDA breakthrough therapy designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious or life-threatening diseases and to help ensure that patients receive access to medicines as soon as possible. This is the seventeenth breakthrough therapy designation for Roche’s portfolio of medicines, and the fourth for Venclexta.

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Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.
Breakthrough therapy designation was granted based on data from an ongoing open-label phase Ib study of Venclexta in combination with LDAC in previously untreated elderly patients (over 65 years) with AML, an aggressive form of leukaemia, who are ineligible for intensive chemotherapy. Preliminary data from this study (M14-387) presented at the 22nd European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, 22-25 June, in Madrid 2017 (Abstract E911) showed durable efficacy with an acceptable safety profile for Venclexta in combination with LDAC in this patient group.

About AML
AML is an aggressive form of leukaemia that starts in immature forms of blood-forming cells, known as myeloid cells, found in the bone marrow.2 AML is the most common type of aggressive leukaemia in adults.1 It has one of the lowest survival rates of all types of leukaemia3. Even with the best available therapies, older patients aged 65 and over have survival rates comparable to patients with advanced lung cancer, with a five year overall survival rate of <5%.4,5 Approximately 20,000 people in the United States and 18,000 in Europe are diagnosed with AML each year.6,7

About Venclexta
Venclexta is a small molecule designed to selectively bind and inhibit the BCL-2 protein, which plays an important role in a process called apoptosis (programmed cell death). It is believed that blocking BCL-2 may restore the signalling system that tells cells, including cancer cells, to self-destruct.

Venclexta is being co-developed by AbbVie and Roche. Together, the companies are committed to research with Venclexta, which is currently being evaluated in phase III clinical trials for the treatment of relapsed, refractory and previously untreated chronic lymphocytic leukaemia, along with studies in several other cancers including AML. Venclexta is commercialised jointly by AbbVie and Genentech, a member of the Roche Group, in the United States and commercialised by AbbVie outside of the United States.

On July 28, 2017 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported financial results for the second quarter of 2017 (Press release, Merck & Co, JUL 28, 2017, View Source [SID1234519928]).

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"We continued to deliver strong results in the second quarter, driven by robust momentum for KEYTRUDA and good progress with other products in our portfolio," said Kenneth C. Frazier, chairman and chief executive officer, Merck. "The company continues to invest in innovative science that addresses the critical needs of population health, which benefits patients while creating long-term value for shareholders."

Financial Summary


Second Quarter
$ in millions, except EPS amounts 2017 2016
Sales $9,930 $9,844
GAAP net income1
1,946 1,205
Non-GAAP net income that excludes items listed below1,2
2,778 2,587
GAAP EPS 0.71 0.43
Non-GAAP EPS that excludes items listed below2
1.01 0.93

Worldwide sales were $9.9 billion for the second quarter of 2017, an increase of 1 percent compared with the second quarter of 2016, including a 1 percent negative impact from foreign exchange.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) were $0.71 for the second quarter of 2017. Non-GAAP EPS of $1.01 for the second quarter of 2017 excludes acquisition- and divestiture-related costs, restructuring costs and certain other items. Year-to-date results can be found in the attached tables.

Pipeline Highlights

Merck made significant advances in the development program for KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, receiving key regulatory approvals and a supplemental Biologics License Application (sBLA) acceptance.

The U.S. Food and Drug Administration (FDA) approved KEYTRUDA under its Accelerated Approval program:
In combination with pemetrexed and carboplatin for the treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression. This is the first regulatory approval of KEYTRUDA in combination with another treatment. The National Cancer Care Network (NCCN) also recommended the combination for the treatment of patients with metastatic nonsquamous NSCLC.
For the treatment of previously treated patients with advanced microsatellite instability-high cancers.
For the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer, for first-line use in patients who are ineligible for cisplatin-containing therapy.
The FDA approved KEYTRUDA for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma in the second-line setting for patients who have disease progression during or following platinum-containing chemotherapy.
The European Commission approved KEYTRUDA for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant and brentuximab vedotin (BV), or who are transplant-ineligible and have failed BV.
The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of KEYTRUDA for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, with a final decision expected in the third quarter of 2017.
The FDA accepted for review the sBLA for KEYTRUDA for the treatment of patients with recurrent or advanced gastric or gastroesophageal junction adenocarcinoma who have already received two or more lines of chemotherapy. The FDA granted Priority Review with a PDUFA action date of Sept. 22, 2017.
The FDA granted Breakthrough Therapy Designation for KEYTRUDA in combination with axitnib as a first-line treatment for patients with advanced or metastatic renal cell carcinoma.
The company previously announced that the pivotal Phase 3 KEYNOTE-040 trial investigating KEYTRUDA in previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma did not meet its primary endpoint of overall survival (HR, 0.82 [95% CI, 0.67-1.01]; one-sided p = 0.03). The safety profile observed in KEYNOTE-040 was consistent with that observed in previously reported studies of KEYTRUDA without new safety signals identified. The final data from KEYNOTE-040 will be presented at an upcoming medical meeting.

At the 77th Scientific Sessions of the American Diabetes Association, Merck in partnership with Pfizer presented data from two Phase 3 studies of ertugliflozin, an investigational oral SGLT-2 inhibitor in development to help improve glycemic control in adults with type 2 diabetes, which met their primary endpoints. Three New Drug Applications for medicines containing ertugliflozin are currently under review with the FDA and EMA.

Phase 3 results from the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study of anacetrapib met its primary endpoint, significantly reducing major coronary events (defined as the composite of coronary death, myocardial infarction, and coronary revascularization) compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen. The safety profile of anacetrapib in the early analysis was generally consistent with that demonstrated in previous studies of the drug, including accumulation of anacetrapib in adipose tissue, as has been previously reported. Merck plans to review the results of the trial with external experts, and will consider whether to file new drug applications with the FDA and other regulatory agencies.

New data from the company’s HIV portfolio and pipeline were presented at the 9th IAS Conference on HIV Science.

Week 96 results from the pivotal Phase 3 ONCEMRK study evaluating the efficacy and safety of ISENTRESS HD, a 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS (raltegravir), met its primary efficacy endpoint of non-inferiority to twice-daily ISENTRESS, with a similar safety and tolerability profile, reaffirming the comparable efficacy and safety of ISENTRESS HD. ISENTRESS HD is now approved in the United States and European Union.
48 week data from DRIVE-AHEAD, the second of two pivotal Phase 3 studies evaluating doravirine (MK-1439), an investigational non-nucleoside reverse transcriptase inhibitor, for the treatment of HIV-1 infection showed that a once-daily single tablet, fixed-dose combination of doravirine, lamivudine and tenofovir disoproxil fumarate met its primary endpoint. Based on these findings the company plans to file regulatory applications in the fourth quarter of 2017.
Results from a Phase 1 study of MK-8591, Merck’s investigational nucleoside reverse transcriptase translocation inhibitor in adult patients with HIV-1 infection.
Merck entered into an exclusive worldwide license agreement with Teijin Pharma for the development, manufacture and commercialization of an investigational preclinical antibody candidate targeting the protein tau. Changes in tau are associated with a number of diseases affecting the nervous system, including Alzheimer’s disease.

Recent Developments

Merck entered a global strategic oncology collaboration with AstraZeneca to co-develop and co-commercialize AstraZeneca’s Lynparza (olaparib), a PARP inhibitor, and investigational medicine selemetinib, a MEK inhibitor, as monotherapy and in combination treatments for multiple cancer types. Merck and AstraZeneca will independently develop and commercialize Lynparza and selumetinib in combinations with the companies’ respective PD-1 and PD-L1 immuno-oncology medicines KEYTRUDA and Imfinzi (durvalumab). The companies will share development and marketing costs equally, as well as gross profits from Lynparza and selumetinib.

Second-Quarter Revenue Performance

The following table reflects sales of the company’s top pharmaceutical products, as well as total sales of Animal Health products.


$ in millions Second Quarter
2017 2016 Change
Change
Ex-Exchange
Total Sales $9,930 $9,844 1% 2%
Pharmaceutical 8,759 8,700 1% 2%
JANUVIA / JANUMET 1,511 1,634 -8% -7%
KEYTRUDA 881 314 180% 183%
ZETIA / VYTORIN 549 994 -45% -44%
ZEPATIER 517 112 * *
GARDASIL / GARDASIL 9 469 393 19% 20%
PROQUAD,
M-M-R II and VARIVAX 399 383 4% 5%
ISENTRESS / ISENTRESS HD 282 338 -17% -15%
REMICADE 208 339 -39% -36%
SINGULAIR 203 229 -11% -10%
Animal Health 955 900 6% 7%
Other Revenues 216 244 -11% -5%
*Growth comparison not meaningful due to ongoing product launch.


Pharmaceutical Revenue

Second-quarter pharmaceutical sales increased 1 percent to $8.8 billion, including a 1 percent negative impact from foreign exchange. The growth was primarily driven by product launches and vaccines, largely offset by the loss of market exclusivity for several products, as well as lower sales in the diabetes franchise.

Growth in oncology was due to higher sales of KEYTRUDA as the company continues to launch the product with new indications globally. Strong momentum from NSCLC, as KEYTRUDA is the only anti-PD-1 approved in the first-line setting, contributed significantly to KEYTRUDA’s overall growth.

Growth in hepatitis C was driven by ZEPATIER (elbasvir and grazoprevir), a medicine for the treatment of chronic hepatitis C virus genotypes 1 or 4 infection, due to ongoing launches globally.

Additionally, the ongoing launch of BRIDION (sugammadex) Injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery, generated sales of $163 million and also contributed to growth during the second quarter of 2017.

Growth in vaccines was primarily driven by higher sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccines to prevent certain cancers and other diseases caused by HPV, reflecting strong demand in Asia Pacific and the timing of sales in Brazil. Growth in vaccines also reflects higher sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, largely driven by volume growth and pricing in the United States. Additionally, vaccines sales growth reflects incremental sales of approximately $70 million, of which approximately $40 million relates to GARDASIL and GARDASIL 9, due to the recording of vaccine sales from 19 European countries that were part of the Sanofi Pasteur MSD (SPMSD) vaccines joint venture, which was terminated on Dec. 31, 2016.

Pharmaceutical sales reflect a decrease in the diabetes franchise of JANUVIA and JANUMET (sitagliptin and metformin HCl), medicines that help lower blood sugar in adults with type 2 diabetes, primarily due to lower sales in the United States, reflecting continued pricing pressure and lower customer inventory levels that were partially offset by continued volume growth. Pharmaceutical sales growth also was offset by the loss of U.S. market exclusivity for ZETIA (ezetimibe) in late 2016 and VYTORIN (ezetimibe/simvastatin) in April 2017, medicines for lowering LDL cholesterol, and the ongoing impacts of generic competition for CUBICIN (daptomycin for injection), an I.V. antibiotic, and biosimilar competition for REMICADE (infliximab), a treatment for inflammatory diseases, in the company’s marketing territories in Europe. In the aggregate, sales of these products declined $830 million during the second quarter of 2017 compared to the second quarter of 2016.

Animal Health Revenue

Animal Health sales totaled $955 million for the second quarter of 2017, an increase of 6 percent compared with the second quarter of 2016, including a 1 percent negative impact from foreign exchange. Growth was primarily due to sales increases in companion animal products, driven by the BRAVECTO (fluralaner) line of products that kill fleas and ticks in dogs and cats for up to 12 weeks, and the NOBIVAC Canine Flu Bivalent vaccine, as well as sales increases in ruminants products, reflecting the positive impact of the Vallée S.A. acquisition.

Second-Quarter Expense, EPS and Related Information

The table below presents selected expense information.


Second-Quarter 2017


GAAP

Acquisition- and
Divestiture-
Related Costs 3

Restructuring
Costs


Non-GAAP 2
Materials and production $3,080 $827 $33 $2,220
Marketing and administrative 2,438 9 2 2,427
Research and development 1,749 7 9 1,733
Restructuring costs 166 – 166
—
Other (income) expense, net 58 39 – 19

Second-Quarter 2016
Materials and production $3,578 $1,120 $66 $2,392
Marketing and administrative 2,458 18 87 2,353
Research and development 2,151 207 64 1,880
Restructuring costs 134 – 134 –
Other (income) expense, net 19 – – 19

GAAP Expense, EPS and Related Information

On a GAAP basis, the gross margin was 69.0 percent for the second quarter of 2017 compared to 63.7 percent for the second quarter of 2016. The increase in gross margin for the second quarter of 2017 was primarily driven by lower acquisition- and divestiture-related costs and restructuring costs, which reduced gross margin by 8.6 percentage points in the second quarter of 2017 compared with 12.0 percentage points in the second quarter of 2016. The increase also reflects the favorable effects of product mix and lower inventory write-offs.

Marketing and administrative expenses were $2.4 billion in the second quarter of 2017, a 1 percent decrease compared to the second quarter of 2016. The decrease primarily reflects lower restructuring costs partially offset by higher administrative costs including costs associated with the company now operating its European vaccines business in the countries that were part of the SPMSD vaccines joint venture, which was terminated on Dec. 31, 2016, and higher promotion expenses related to product launches.

Research and development (R&D) expenses were $1.7 billion in the second quarter of 2017, a 19 percent decrease compared to the second quarter of 2016. The decrease primarily reflects lower intangible asset impairment charges and licensing costs.

GAAP EPS was $0.71 for the second quarter of 2017 compared with $0.43 for the second quarter of 2016.

Non-GAAP Expense, EPS and Related Information

The non-GAAP gross margin was 77.6 percent for the second quarter of 2017 compared to 75.7 percent for the second quarter of 2016. The increase in non-GAAP gross margin was largely driven by the favorable effects of product mix and lower inventory write-offs.

Non-GAAP marketing and administrative expenses were $2.4 billion in the second quarter of 2017, an increase of 3 percent compared to the second quarter of 2016. The increase was driven primarily by higher administrative costs, including costs associated with the company now operating its European vaccines business in the countries that were previously part of the SPMSD vaccines joint venture, and higher promotion expenses related to product launches.

Non-GAAP R&D expenses were $1.7 billion in the second quarter of 2017, an 8 percent decrease compared to the second quarter of 2016. The decrease primarily reflects lower licensing costs.

Non-GAAP EPS was $1.01 for the second quarter of 2017 compared with $0.93 for the second quarter of 2016.

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.


$ in millions, except EPS amounts Second Quarter
2017 2016
EPS
GAAP EPS $0.71 $0.43
Difference4
0.30 0.50
Non-GAAP EPS that excludes items listed below2
$1.01 $0.93

Net Income
GAAP net income1
$1,946 $1,205
Difference 832 1,382
Non-GAAP net income that excludes items listed below1,2
$2,778 $2,587

Decrease (Increase) in Net Income Due to Excluded Items:
Acquisition- and divestiture-related costs3 $882 $1,345
Restructuring costs 210 351
Net decrease (increase) in income before taxes 1,092 1,696
Income tax (benefit) expense5 (260) (314)
Decrease (increase) in net income $832 $1,382

Financial Outlook

On June 27, 2017, the company experienced a network cyber-attack that led to a disruption of its worldwide operations, including manufacturing, research and sales operations. While the company does not yet know the magnitude of the impact of the disruption, which remains ongoing in certain operations, it continues to work to minimize the effects.

The company is in the process of restoring its manufacturing operations. To date, Merck has largely restored its packaging operations and has partially restored its formulation operations. The company is in the process of restoring its Active Pharmaceutical Ingredient operations but is not yet producing bulk product. The company’s external manufacturing was not impacted. Throughout this time, Merck has continued to fulfill orders and ship product.

The company is confident in the continuous supply of key products such as KEYTRUDA, JANUVIA and ZEPATIER. In addition, Merck does not currently expect a significant impact to sales of its other top products; however, the company anticipates that it will have temporary delays in fulfilling orders for certain other products in certain markets.

The financial outlook below reflects the current state of the company’s manufacturing operations as well as its plans to restore those operations and potential costs associated with the remediation efforts.

Merck has reduced its full-year 2017 GAAP EPS range to be between $1.60 and $1.72. The change in the GAAP EPS range reflects the inclusion of licensing expenses related to the collaboration with AstraZeneca. Merck has maintained its full-year 2017 non-GAAP EPS range to be between $3.76 and $3.88, including an approximately 1 percent negative impact from foreign exchange at mid-July 2017 exchange rates. The non-GAAP range excludes acquisition- and divestiture-related costs, costs related to restructuring programs and certain other items, including licensing expenses related to the collaboration with AstraZeneca as shown in the table below.

Merck has narrowed and raised its full-year 2017 revenue range to be between $39.4 billion and $40.4 billion, including an approximately 1 percent negative impact from foreign exchange at mid-July 2017 exchange rates.

The following table summarizes the company’s 2017 financial guidance.


GAAP
Non-GAAP 2

Revenue $39.4 to $40.4 billion $39.4 to $40.4 billion**
Operating expenses Lower than 2016 Higher than 2016 by a mid-single digit rate
Effective tax rate 32.0% to 33.0% 21.0% to 22.0%
EPS $1.60 to $1.72 $3.76 to $3.88
**The company does not have any non-GAAP adjustments to revenue.


A reconciliation of anticipated 2017 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below.


$ in millions, except EPS amounts

Full-Year 2017

GAAP EPS $1.60 to $1.72
Difference4 2.16
Non-GAAP EPS that excludes items listed below1 $3.76 to $3.88

Acquisition- and divestiture-related costs $3,600
Restructuring costs 600
Licensing expense relating to AstraZeneca collaboration 2,350
Net decrease (increase) in income before taxes 6,550
Estimated income tax (benefit) expense (610)
Decrease (increase) in net income $5,940

The expected full-year 2017 GAAP effective tax rate of 32.0 to 33.0 percent reflects an unfavorable impact of approximately 11 percentage points from the above items.

Total Employees

As of June 30, 2017, Merck had approximately 69,000 employees worldwide.

On July 28, 2017 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2017 (Press release, AbbVie, JUL 28, 2017, View Source [SID1234519917]).

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“We are pleased with the continued strength of our business. Our second quarter financial results reflected strong commercial and operational execution,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “We also remain very encouraged about the recent progress we’ve made with our late-stage pipeline, including strong results from a registrational trial of our selective JAK1 inhibitor, upadacitinib. We look forward to seeing data from numerous additional pivotal studies in the second half.”

Second-Quarter Results

Worldwide net revenues were $6.944 billion in the second quarter, up 7.6 percent year-over-year, on a GAAP basis. On an operational basis, adjusted net revenues increased 8.9 percent, excluding a 0.9 percent unfavorable impact from foreign exchange.
Global HUMIRA sales increased 13.7 percent on a reported basis, or 14.9 percent operationally, excluding a 1.2 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 18.0 percent in the quarter. Internationally, HUMIRA sales grew 9.1 percent, excluding a 3.6 percent unfavorable impact from foreign exchange.
Second-quarter global IMBRUVICA net revenues were $626 million, with U.S. sales of $528 million and international profit sharing of $98 million for the quarter, reflecting growth of 42.6 percent.
On a GAAP basis, the gross margin ratio in the second quarter was 78.0 percent. The adjusted gross margin ratio was 82.3 percent.
On a GAAP basis, selling, general and administrative expense was 21.7 percent of net revenues. The adjusted SG&A expense was 20.2 percent of net revenues.
On a GAAP basis, research and development expense was 17.6 percent of net revenues. The adjusted R&D expense was 17.5 percent, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the second quarter was 38.5 percent. The adjusted operating margin was 44.6 percent.
On a GAAP basis, net interest expense was $253 million. On a GAAP basis, the tax rate in the quarter was 18.6 percent. The adjusted tax rate was 19.3 percent.
Diluted EPS in the second quarter was $1.19 on a GAAP basis. Adjusted diluted EPS, excluding intangible asset amortization expense and other specified items, was $1.42, up 12.7 percent.
Key Events from the Second Quarter

AbbVie announced positive top-line results from a Phase 3 clinical trial of upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis. Results from the SELECT-NEXT study, which evaluated upadacitinib in patients who did not adequately respond to treatment with conventional synthetic DMARDs, showed that after 12 weeks of treatment, both doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20 and low disease activity. Key secondary endpoints were also achieved and included ACR50, ACR70 and clinical remission. The safety profile was consistent with that observed in the upadacitinib Phase 2 clinical trials, and no new safety signals were detected. Detailed study results will be presented at an upcoming medical conference.
AbbVie presented data on upadacitinib and risankizumab, an investigational IL-23 inhibitor being developed in collaboration with Boehringer Ingelheim, at the annual Digestive Disease Week (DDW) conference. These data included positive results from CELEST, a Phase 2 study evaluating upadacitinib in adult patients with moderately to severely active Crohn’s disease, the majority of whom had previously failed two or more biologics. The CELEST study evaluated the safety and efficacy of multiple dosing regimens after 16 weeks of treatment, and demonstrated that significantly more patients achieved clinical remission and endoscopic remission after induction therapy with upadacitinib versus placebo. Additionally, AbbVie presented data from a Phase 2, open-label maintenance therapy study that demonstrated that after 52 weeks of treatment in patients with moderately to severely active Crohn’s disease, risankizumab was effective in maintaining clinical and endoscopic remission and response in patients who were in clinical remission at week 26. The positive results from both studies support advancement of the upadacitinib and risankizumab Crohn’s disease programs to Phase 3.
AbbVie announced that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending marketing authorization of MAVIRET (glecaprevir/pibrentasvir, or G/P), an investigational, pan-genotypic treatment for adults with chronic HCV infection. If approved, MAVIRET will be a once-daily, ribavirin-free, 8-week option for patients without cirrhosis and who are new to treatment across all genotypes (GT1-6). This group comprises the majority of people living with HCV. MAVIRET would also be an additional HCV treatment option for patients with specific treatment challenges, such as those with compensated cirrhosis, chronic kidney disease and genotype 3 chronic HCV infection. The European Commission will review the CHMP opinion and a final decision is expected in the third quarter of 2017. AbbVie’s next-generation regimen is also under priority review by the U.S. Food and Drug Administration (FDA) and the Japanese Ministry of Health, Labour, and Welfare, and the company anticipates regulatory approvals in the third quarter of 2017.
AbbVie presented data on IMBRUVICA (ibrutinib) at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June. These data included long-term follow-up results from the pivotal Phase 3 RESONATE trial that showed a progression free survival rate of 59 percent in up to four years in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) treated with ibrutinib, including those with high-risk disease. IMBRUVICA is jointly developed and commercialized with Janssen Biotech, Inc.
AbbVie announced results from an analysis of data pooled from three Phase 3 studies evaluating IMBRUVICA use in patients with high-risk CLL/SLL (RESONATE, RESONATE-2 and HELIOS), which were presented at the International Workshop on Chronic Lymphocytic Leukemia meeting. The results suggest that risk factors typically associated with poor clinical outcomes may be less important with ibrutinib treatment, and ibrutinib-treated patients with deletion 11q (a difficult-to-treat genomic abnormality) showed trends of longer progression free survival at 24 months and overall survival at 30 months.
The FDA granted Breakthrough Therapy Designation (BTD) for VENCLEXTA (venetoclax) in combination with low-dose cytarabine for untreated acute myeloid leukemia (AML) patients who are ineligible for intensive chemotherapy. This represents the second BTD for VENCLEXTA in AML, an aggressive blood cancer that, if left untreated, can progress quickly, and the fourth BTD overall for VENCLEXTA. VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group.
AbbVie, in cooperation with Neurocrine Biosciences, Inc., presented data at the World Congress on Endometriosis from two replicate Phase 3 studies, highlighting the efficacy and safety profile of elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, in premenopausal women with endometriosis. Regulatory submission for elagolix is expected in the third quarter.
Full-Year 2017 Outlook

AbbVie is confirming its GAAP diluted EPS guidance for the full-year 2017 of $4.55 to $4.65. AbbVie expects to deliver adjusted diluted EPS for the full-year 2017 of $5.44 to $5.54, representing growth of 13.9 percent at the mid-point. The company’s 2017 adjusted diluted EPS guidance excludes $0.89 per share of intangible asset amortization expense and other specified items.