On October 26, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the third quarter of 2017, which were highlighted by strong sales for key products Opdivo and Eliquis and multiple regulatory approvals for Opdivo (Press release, Bristol-Myers Squibb, OCT 26, 2017, View Source [SID1234521194]).

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“We had a good quarter, demand for Eliquis and Opdivo was strong and we advanced our portfolio with important clinical and regulatory milestones, including exciting data for kidney cancer patients with Opdivo + Yervoy,” said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. “Looking forward, our focus is on continuing to deliver strong commercial performance, advance our pipeline and ensure our resources are applied to priority areas of our portfolio for sustainable, long-term growth.”

Third Quarter
$ amounts in millions, except per share amounts
2017
2016
Change
Total Revenues $5,254 $4,922 7%
GAAP Diluted EPS 0.51 0.72 (29)%
Non-GAAP Diluted EPS 0.75 0.77 (3)%

THIRD QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted third quarter 2017 revenues of $5.3 billion, an increase of 7% compared to the same period a year ago. Revenues increased 6% when adjusted for foreign exchange impact.
U.S. revenues increased 3% to $2.9 billion in the quarter compared to the same period a year ago. International revenues increased 12%. When adjusted for foreign exchange impact, international revenues increased 11%.
Gross margin as a percentage of revenue decreased from 73.5% to 70.1% in the quarter primarily due to product mix and an inventory charge.
Marketing, selling and administrative expenses remained flat at $1.1 billion in the quarter.
Research and development expenses increased 36% to $1.5 billion in the quarter primarily due to the IFM Therapeutics (IFM) acquisition charge of $310 million in the current period.
The effective tax rate was 27.6% in the quarter, compared to 22.1% in the third quarter last year. The IFM acquisition charge was not deductible for tax purposes.
The company reported net earnings attributable to Bristol-Myers Squibb of $845 million, or $0.51 per share, in the third quarter compared to net earnings of $1.2 billion, or $0.72 per share, for the same period in 2016.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.2 billion, or $0.75 per share, in the third quarter, compared to $1.3 billion, or $0.77 per share, for the same period in 2016. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.
Cash, cash equivalents and marketable securities were $9.6 billion, with a net cash position of $1.2 billion, as of September 30, 2017.
THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

The increase in global revenues for the third quarter of 2017, compared to the third quarter of 2016, was driven by:

Product

Growth %
Eliquis 39%
Opdivo 38%
Yervoy
13%
Orencia
10%
Sprycel
8%

Opdivo

Regulatory

In October, the company announced the FDA accepted for priority review a sBLA for Opdivo to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection.
In September, the company announced the FDA approval of Opdivo for the treatment of hepatocellular carcinoma patients previously treated with sorafenib. Opdivo is the first and only Immuno-Oncology (I-O) agent to receive FDA approval in this population.
In September, the company announced the Japan Ministry of Health, Labor and Welfare approved Opdivo for the treatment of patients with unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. Opdivo is the first and only I-O treatment to demonstrate survival benefit in patients who underwent two or more prior treatments.
In August, the company announced the FDA approval for Opdivo for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
Clinical

In October, at the World Conference on Lung Cancer in Yokohama, Japan, the company presented numerous studies for Opdivo and Opdivo-based combinations across types of thoracic cancers including exploratory data evaluating Opdivo and the Opdivo + Yervoy regimen in patients with previously treated small cell lung cancer (SCLC) whose tumors were evaluable for tumor mutation burden (TMB), a subgroup of the Phase 1/2 open-label CheckMate -032 study. (link)
In September, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress in Madrid, Spain, the company presented numerous studies for Opdivo, the Opdivo + Yervoy regimen, Opdivo in combination with other assets and analyses providing insights into the potential role of biomarkers to predict patients’ treatment responses. The company announced results from the following studies:
CheckMate -238: Interim data from the Phase 3 study evaluating Opdivo versus Yervoy in patients with resected high-risk melanoma. Opdivo is the first anti-PD-1 to improve recurrence-free survival and only I-O therapy to demonstrate superiority versus an active control in this patient population. (link)
CheckMate -214: First presentation of efficacy data from the Phase 3 study of the Opdivo + Yervoy combination vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). (link) The topline results were announced in August. (link) In September, this trial was stopped early for demonstrating overall survival benefit to patients with previously untreated advanced or metastatic RCC. (link)
CheckMate -017 and -057: Three-year survival data from two Phase 3 studies of Opdivo vs. docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC). (link)
In September, the company announced the FDA placed a partial clinical hold on CheckMate -602, CheckMate -039 and CA204142, three studies investigating Opdivo-based combinations in patients with relapsed or refractory multiple myeloma, based on risks identified in trials studying another anti-PD-1 agent, pembrolizumab, in patients with multiple myeloma.
Yervoy

Today the company is announcing the FDA added five-year overall survival data from the Phase 3 CA184-029 trial, to the prescribing information for Yervoy for the adjuvant treatment of fully resected cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm. Yervoy is the first immune checkpoint inhibitor to demonstrate a statistically significant improvement in overall survival in this patient population.

Eliquis

In August, at the 17th European Society of Cardiology Congress in Barcelona, Spain, the company and Pfizer Inc. presented findings from three studies evaluating Eliquis (apixaban):

EMANATE, a Phase 4 clinical trial, evaluating Eliquis for patients with non-valvular atrial fibrillation undergoing cardioversion. (link)
Real-world data analysis of the U.S. Humana database of treatment with Eliquis compared to warfarin in patients aged 65 years and older with non-valvular atrial fibrillation. (link)
Real-world data analysis pooled from four large U.S. insurance claims databases on the effectiveness and safety of Eliquis compared to warfarin in the overall patient population, as well as select high-risk patients, with non-valvular atrial fibrillation. (link)
THIRD QUARTER BUSINESS DEVELOPMENT UPDATE

In September, the company completed the acquisition of all outstanding capital stock of IFM, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders. The acquisition gives the company full rights to IFM’s preclinical STING (stimulator of interferon genes) and NLRP3 agonist programs focused on enhancing the innate immune response for treating cancer.
In September, the company and AbbVie announced a clinical trial collaboration to evaluate the combination of Opdivo and AbbVie’s investigational antibody drug conjugate ABBV-399 in c-Met overexpressing NSCLC, with the possible expansion into additional solid tumors.
In September, the company and Halozyme Therapeutics, Inc. announced a global collaboration and license agreement to develop subcutaneous presentations of its immuno-oncology medicines using Halozyme’s ENHANZE drug-delivery technology.
In August, the company and Daiichi Sankyo Company, Limited announced a collaborative clinical trial to evaluate the combination of Opdivo and Daiichi Sankyo’s investigational antibody drug conjugate DS-8201 in HER2-expressing metastatic breast and urothelial (bladder) cancers.
In July, the company and Clovis Oncology, Inc. announced a clinical collaboration to evaluate the combination of Opdivo and Clovis Oncology’s poly (ADP-ribose) polymerase (PARP) inhibitor Rubraca (rucaparib) in Phase 3 clinical trials in advanced ovarian and advanced triple-negative breast cancers. The agreement also includes a Phase 2 study to evaluate the safety and efficacy of Opdivo + Rubraca combination in patients with metastatic castration-resistant prostate cancer.
In July, the company and Exelixis, Inc. announced the initiation of the Phase 3 CheckMate 9ER trial to evaluate Opdivo in combination with CABOMETYX (cabozantinib) tablets, a small molecule inhibitor of receptor tyrosine kinases, or the Opdivo + Yervoy combination with CABOMETYX versus sunitinib in patients with previously untreated, advanced or metastatic RCC.
2017 FINANCIAL GUIDANCE

Bristol-Myers Squibb is decreasing its 2017 GAAP EPS guidance range from $2.66 – $2.76 to $2.36 – $2.46 and is increasing its non-GAAP EPS guidance range from $2.90 – $3.00 to $2.95 – $3.05. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2017 GAAP and non-GAAP line-item guidance assumptions include:

Gross margin as a percentage of revenue to be approximately 71.5% for GAAP.
Research and development expenses are increasing approximately 25% – 30% compared to 2016 for GAAP.
An effective tax rate of approximately 25% – 26% for GAAP and approximately 22% for non-GAAP.
The financial guidance excludes the impact of any potential future strategic acquisitions and divestitures and any specified items that have not yet been identified and quantified. The non-GAAP guidance also excludes other specified items as discussed under “Use of Non-GAAP Financial Information.” Details reconciling GAAP amounts to non-GAAP amounts, with non-GAAP reflecting specified items are provided in supplemental materials attached to this press release and available on the company’s website.

Rubraca is a trademark of Clovis Oncology, Inc.

Cabometyx is a trademark of Exelixis, Inc.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information, that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods including restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges in connection with the acquisition or licensing of third party intellectual property rights, divestiture gains or losses, upfront payments from out licensed assets, pension charges, legal and other contractual settlements and debt redemption gains or losses, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. Non-GAAP information is intended to portray the results of our baseline performance, supplement or enhance management, analysts and investors overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of our baseline performance before items that are considered by us to not be reflective of our ongoing results. In addition, this information is among the primary indicators we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP.

Statement on Cautionary Factors

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. These statements may be identified by the fact that they use words such as “anticipate”, “estimates”, “should”, “expect”, “guidance”, “project”, “intend”, “plan”, “believe” and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, effects of the continuing implementation of governmental laws and regulations related to Medicare, Medicaid, Medicaid managed care organizations and entities under the Public Health Service 340B program, pharmaceutical rebates and reimbursement, market factors, competitive product development and approvals, pricing controls and pressures (including changes in rules and practices of managed care groups and institutional and governmental purchasers), economic conditions such as interest rate and currency exchange rate fluctuations, judicial decisions, claims and concerns that may arise regarding the safety and efficacy of in-line products and product candidates, changes to wholesaler inventory levels, variability in data provided by third parties, changes in, and interpretation of, governmental regulations and legislation affecting domestic or foreign operations, including tax obligations, changes to business or tax planning strategies, difficulties and delays in product development, manufacturing or sales including any potential future recalls, patent positions and the ultimate outcome of any litigation matter. These factors also include the company’s ability to execute successfully its strategic plans, including its business development strategy, the expiration of patents or data protection on certain products, including assumptions about the company’s ability to retain patent exclusivity of certain products, and the impact and result of governmental investigations. There can be no guarantees with respect to pipeline products that future clinical studies will support the data described in this release, that the compounds will receive necessary regulatory approvals, or that they will prove to be commercially successful; nor are there guarantees that regulatory approvals will be sought, or sought within currently expected timeframes, or that contractual milestones will be achieved. For further details and a discussion of these and other risks and uncertainties, see the company’s periodic reports, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Company and Conference Call Information

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook.

There will be a conference call on October 26, 2017 at 10:30 a.m. EDT during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source or by calling the U.S. toll free 888-394-8218 or international 323-701-0225, confirmation code: 4511781. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 1:30 p.m. EDT on October 26 through 11:59 p.m. EST on November 9, 2017. The replay will also be available through View Source or by calling the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4511781.

BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUE
FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(Unaudited, dollars in millions)

Worldwide Revenues U.S. Revenues
2017 2016
%
Change
2017 2016
%
Change
Three Months Ended September 30,
Prioritized Brands
Opdivo $ 1,265 $ 920 38 % $ 778 $ 712 9 %
Eliquis 1,232 884 39 % 717 512 40 %
Orencia 632 572 10 % 432 387 12 %
Sprycel 509 472 8 % 278 259 7 %
Yervoy 323 285 13 % 239 222 8 %
Empliciti 60 41 46 % 39 36 8 %

Established Brands
Hepatitis C Franchise 73 379 (81 )% 24 192 (88 )%
Baraclude 264 306 (14 )% 14 17 (18 )%
Sustiva Franchise 183 275 (33 )% 157 234 (33 )%
Reyataz Franchise 174 238 (27 )% 85 125 (32 )%
Other Brands 539 550 (2 )% 101 94 7 %

Total $ 5,254 $ 4,922 7 % $ 2,864 $ 2,790 3 %

BRISTOL-MYERS SQUIBB COMPANY
PRODUCT REVENUE
FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(Unaudited, dollars in millions)

Worldwide Revenues U.S. Revenues
2017 2016
%
Change
2017 2016
%
Change
Nine Months Ended September 30,
Prioritized Brands
Opdivo $ 3,587 $ 2,464 46 % $ 2,307 $ 1,949 18 %
Eliquis 3,509 2,395 47 % 2,119 1,424 49 %
Orencia 1,817 1,640 11 % 1,243 1,109 12 %
Sprycel 1,478 1,330 11 % 806 702 15 %
Yervoy 975 789 24 % 727 600 21 %
Empliciti 168 103 63 % 112 97 15 %

Established Brands
Hepatitis C Franchise 347 1,352 (74 )% 96 745 (87 )%
Baraclude 819 896 (9 )% 40 49 (18 )%
Sustiva Franchise 555 819 (32 )% 471 689 (32 )%
Reyataz Franchise 555 706 (21 )% 260 367 (29 )%
Other Brands 1,517 1,690 (10 )% 286 284 1 %

Total $ 15,327 $ 14,184 8 % $ 8,467 $ 8,015 6 %

BRISTOL-MYERS SQUIBB COMPANY
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(Unaudited, dollars and shares in millions except per share data)

Three Months Ended
September 30,

Nine Months Ended
September 30,
2017 2016 2017 2016
Net product sales $ 4,862 $ 4,492 $ 14,212 $ 12,888
Alliance and other revenues 392 430 1,115 1,296
Total Revenues 5,254 4,922 15,327 14,184

Cost of products sold 1,572 1,305 4,393 3,563
Marketing, selling and administrative 1,147 1,144 3,388 3,450
Research and development 1,543 1,138 4,490 3,540
Other (income)/expense (191 ) (224 ) (1,377 ) (1,198 )
Total Expenses 4,071 3,363 10,894 9,355

Earnings Before Income Taxes 1,183 1,559 4,433 4,829
Provision for Income Taxes 327 344 1,129 1,220

Net Earnings 856 1,215 3,304 3,609
Net Earnings/(Loss) Attributable to Noncontrolling Interest 11 13 (31 ) 46
Net Earnings Attributable to BMS $ 845 $ 1,202 $ 3,335 $ 3,563

Average Common Shares Outstanding:
Basic 1,639 1,671 1,648 1,670
Diluted 1,645 1,679 1,655 1,679

Earnings per Common Share
Basic $ 0.52 $ 0.72 $ 2.02 $ 2.13
Diluted $ 0.51 $ 0.72 $ 2.02 $ 2.12

Other (Income)/Expense
Interest expense $ 48 $ 42 $ 145 $ 127
Investment income (37 ) (32 ) (104 ) (81 )
Provision for restructuring 28 19 207 41
Litigation and other settlements — (1 ) (489 ) 48
Equity in net income of affiliates (21 ) (19 ) (59 ) (65 )
Divestiture (gains)/losses 1 (21 ) (126 ) (574 )
Royalties and licensing income (209 ) (158 ) (1,093 ) (579 )
Transition and other service fees (12 ) (57 ) (32 ) (184 )
Pension charges 22 19 91 66
Intangible asset impairments — — — 15
Equity investment impairment — — — 45
Loss on debt redemption — — 109 —
Other (11 ) (16 ) (26 ) (57 )
Other (income)/expense $ (191 ) $ (224 ) $ (1,377 ) $ (1,198 )

BRISTOL-MYERS SQUIBB COMPANY
SPECIFIED ITEMS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(Unaudited, dollars in millions)

Three Months Ended
September 30,

Nine Months Ended
September 30,
2017 2016 2017 2016
Impairment charges $ 1 $ — $ 128 $ —
Accelerated depreciation and other shutdown costs — 7 3 15
Cost of products sold 1 7 131 15

License and asset acquisition charges 310 45 753 309
IPRD impairments — — 75 —
Accelerated depreciation and other 64 14 232 40
Research and development 374 59 1,060 349

Provision for restructuring 28 19 207 41
Divestiture gains — (13 ) (100 ) (559 )
Pension charges 22 19 91 66
Litigation and other settlements — (3 ) (481 ) 40
Intangible asset impairments — — — 15
Loss on debt redemption — — 109 —
Royalties and licensing income — — (497 ) —
Other (income)/expense 50 22 (671 ) (397 )

Increase/(decrease) to pretax income 425 88 520 (33 )

Income taxes on specified items (41 ) (3 ) 51 156

Increase to net earnings 384 85 571 123

Noncontrolling interest — — (59 ) —

Increase to net earnings used for diluted Non-GAAP EPS calculation $ 384 $ 85 $ 512 $ 123

BRISTOL-MYERS SQUIBB COMPANY
RECONCILIATION OF CERTAIN GAAP LINE ITEMS TO CERTAIN NON-GAAP LINE ITEMS
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2017 AND 2016
(Unaudited, dollars in millions)

Three Months Ended September 30, 2017 Nine Months Ended September 30, 2017
GAAP
Specified
Items(a)

Non-
GAAP
GAAP
Specified
Items(a)

Non-
GAAP
Gross Profit $ 3,682 $ 1 $ 3,683 $ 10,934 $ 131 $ 11,065
Research and development 1,543 (374 ) 1,169 4,490 (1,060 ) 3,430
Other (income)/expense (191 ) (50 ) (241 ) (1,377 ) 671 (706 )
Earnings Before Income Taxes 1,183 425 1,608 4,433 520 4,953
Provision for Income Taxes 327 (41 ) 368 1,129 51 1,078
Noncontrolling interest 11 — 11 (31 ) (59 ) 28

Net Earnings Attributable to BMS used for Diluted EPS Calculation $ 845 $ 384 $ 1,229 $ 3,335 $ 512 $ 3,847

Average Common Shares Outstanding – Diluted 1,645 1,645 1,645 1,655 1,655 1,655
Diluted Earnings Per Share $ 0.51 $ 0.24 $ 0.75 $ 2.02 $ 0.30 $ 2.32

Effective Tax Rate 27.6 % (4.7 )% 22.9 % 25.5 % (3.7 )% 21.8 %

Three Months Ended September 30, 2016 Nine Months Ended September 30, 2016
GAAP
Specified
Items(a)
Non-
GAAP
GAAP
Specified
Items(a)
Non-
GAAP
Gross Profit $ 3,617 $ 7 $ 3,624 $ 10,621 $ 15 $ 10,636
Research and development 1,138 (59 ) 1,079 3,540 (349 ) 3,191
Other (income)/expense (224 ) (22 ) (246 ) (1,198 ) 397 (801 )
Earnings Before Income Taxes 1,559 88 1,647 4,829 (33 ) 4,796
Provision for Income Taxes 344 (3 ) 347 1,220 156 1,064
Noncontrolling interest 13 — 13 46 — 46

Net Earnings Attributable to BMS used for Diluted EPS Calculation $ 1,202 $ 85 $ 1,287 $ 3,563 $ 123 $ 3,686

Average Common Shares Outstanding – Diluted 1,679 1,679 1,679 1,679 1,679 1,679
Diluted Earnings Per Share $ 0.72 $ 0.05 $ 0.77 $ 2.12 $ 0.08 $ 2.20

Effective Tax Rate 22.1 % (1.0 )% 21.1 % 25.3 % (3.1 )% 22.2 %

(a) Refer to the Specified Items schedule for further details. Effective tax rate on the Specified Items represents the difference between the GAAP and Non-GAAP effective tax rate.

BRISTOL-MYERS SQUIBB COMPANY
NET CASH/(DEBT) CALCULATION
AS OF SEPTEMBER 30, 2017 AND JUNE 30, 2017
(Unaudited, dollars in millions)

September 30, 2017 June 30, 2017
Cash and cash equivalents $ 4,644 $ 3,470
Marketable securities – current 2,478 3,035
Marketable securities – non-current 2,526 2,580
Cash, cash equivalents and marketable securities 9,648 9,085
Short-term debt obligations (1,461 ) (1,306 )
Long-term debt (6,982 ) (6,911 )
Net cash position $ 1,205 $ 868

On October 26, 2017 Seattle Genetics, Inc. (NASDAQ: SGEN) reported financial results for the third quarter and nine months ended September 30, 2017 (Press release, Seattle Genetics, OCT 26, 2017, View Source [SID1234521217]).

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The company also highlighted ADCETRIS (brentuximab vedotin) commercialization and clinical development accomplishments, enfortumab vedotin (ASG-22ME) and tisotumab vedotin clinical activities, as well as progress with its pipeline of antibody-drug conjugates (ADCs) and other proprietary programs.

“We have recently delivered on several important goals that continue to strengthen the ADCETRIS brand and advance our portfolio of pipeline programs. The FDA granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy in frontline advanced classical Hodgkin lymphoma based on data from the phase 3 ECHELON-1 clinical trial, and we are on track to submit a supplemental Biologics License Application (BLA) for this indication soon. And, the supplemental BLA for ADCETRIS in cutaneous T-cell lymphoma was filed by the FDA with priority review and a PDUFA date of December 16, 2017,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We have also made significant progress with our pipeline, which now includes two ADCs for which we are pursuing rapid development pathways based on positive FDA feedback. We and our partner Astellas have initiated a pivotal phase 2 trial of enfortumab vedotin in metastatic urothelial cancer, and we and our partner Genmab plan to advance tisotumab vedotin into a pivotal phase 2 trial for recurrent or metastatic cervical cancer in the first half of 2018. We anticipate several additional milestones before the end of 2017, including a strong presence at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December highlighted by a presentation of our full ECHELON-1 data in frontline Hodgkin lymphoma.”

ADCETRIS Program Highlights

ALCANZA Approval Application: The U.S. Food and Drug Administration (FDA) accepted for filing an ADCETRIS supplemental Biologics License Application (BLA) based primarily on data from the phase 3 ALCANZA trial in patients with CD30-expressing mycosis fungoides and primary cutaneous anaplastic large cell lymphoma, the most common subtypes of cutaneous T-cell lymphoma (CTCL). The FDA granted Priority Review to the application and the Prescription Drug User Fee Act (PDUFA) target action date is December 16, 2017. ADCETRIS previously received FDA Breakthrough Therapy Designation in this setting.
Frontline Hodgkin Lymphoma Breakthrough Therapy Designation: The FDA granted Breakthrough Therapy Designation to ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The designation is based on positive results from the phase 3 ECHELON-1 clinical trial.
ECHELON-1 Approval Application: Seattle Genetics expects to submit in the fourth quarter of 2017 a supplemental BLA to the FDA for approval of ADCETRIS in frontline advanced classical Hodgkin lymphoma.
ECHELON-1 Phase 3 Data at ASH (Free ASH Whitepaper): Data from the ECHELON-1 phase 3 trial were accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting being held December 9-12, 2017 in Atlanta, GA. In addition, more than a dozen other ADCETRIS data sets will be featured during the meeting.
ECHELON-2 Phase 3 Trial: ECHELON-2 is a phase 3 trial in frontline CD30-expressing mature T-cell lymphoma (MTCL), also known as peripheral T-cell lymphoma (PTCL). Data from the trial are expected in 2018.
Long-term Follow-up Data in Systemic ALCL: Seattle Genetics and its partner Takeda announced that final data from an ADCETRIS pivotal phase 2 clinical trial in relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) were published in the journal Blood. The manuscript, which summarizes the five-year, end-of-study results, highlights durable, long-term remissions in sALCL patients treated with ADCETRIS monotherapy.
ADCETRIS Approval: Takeda continues to receive additional marketing approvals for ADCETRIS, which is now commercially available in 68 countries worldwide following the recent approval in South Africa.
ADCETRIS is not currently approved for use in CTCL, frontline Hodgkin lymphoma or frontline MTCL.

Enfortumab Vedotin Program Highlights

Pivotal Trial Initiated: Seattle Genetics and its collaborator Astellas initiated a pivotal phase 2 trial of single-agent enfortumab vedotin for locally advanced or metastatic urothelial cancer patients who received prior checkpoint inhibitor (CPI) therapy. The single-arm trial is designed to enroll approximately 120 patients and the primary endpoint is confirmed objective response rate per independent review. The trial may support regulatory submission under the FDA’s accelerated approval regulations.
Combination Clinical Trial Planned: Seattle Genetics and Astellas plan to initiate a phase 1b trial of enfortumab vedotin in combination CPI therapies, including pembrolizumab, for first- or second-line treatment of patients with locally advanced or metastatic urothelial cancer.
Tisotumab Vedotin Program Highlights

Co-development Option Exercised: Seattle Genetics exercised its option to co-develop tisotumab vedotin with Genmab, adding an additional ADC for solid tumors to its pipeline. The decision was based on promising data from a phase 1/2 trial conducted by Genmab in solid tumors, including cervical cancer. Going forward, Genmab and Seattle Genetics will co-develop and share all future costs and profits for tisotumab vedotin on a 50:50 basis.
Phase 1/2 Data in Cervical Cancer: Phase 1/2 data were featured in an oral presentation at the European Society for Medical Oncology annual meeting showing that of 34 relapsed, recurrent and/or metastatic cervical cancer patients evaluable for response, 11 patients (32 percent) achieved a response. Median duration of confirmed responses was 8.3 months. The most common adverse events of any grade were conjunctivitis (50 percent), epistaxis, fatigue and alopecia (47 percent each) and nausea (44 percent).
Planned Pivotal Trial: Seattle Genetics and Genmab announced plans to advance tisotumab vedotin into a pivotal phase 2 trial for recurrent or metastatic cervical cancer that relapses or progresses after standard of care treatment for cervical cancer. The single-arm trial is designed to enroll approximately 100 women and potentially could support registration under the FDA’s accelerated approval regulations.
Other Recent Activities

SGN-LIV1A Combination Clinical Trials: Seattle Genetics entered into collaboration agreements to expand the clinical evaluation of SGN-LIV1A in patients with breast cancer. The ADC will be evaluated in combination with pembrolizumab (KEYTRUDA) under an agreement with Merck and as part of a neoadjuvant treatment in the QuantumLeap Healthcare Collaborative’s phase 2 I-SPY 2 trial. Previously, Seattle Genetics entered into a collaboration with Roche for the evaluation of SGN-LIV1A in combination with atezolizumab (TECENTRIQ) as part of the MORPHEUS trial.
SGN-LIV1A Clinical Data: Data from a phase 1 trial of SGN-LIV1A monotherapy were accepted for presentation at the San Antonio Breast Cancer Symposium taking place December 4-9, 2017.
SGN-CD48A IND: An investigational new drug (IND) application was accepted by the FDA for the novel ADC SGN-CD48A. A phase 1 trial is planned in early 2018 for patients with relapsed multiple myeloma.
Manufacturing Facility: In October 2017, Seattle Genetics closed on its transaction to purchase Bristol-Myers Squibb’s state-of-the-art biologics manufacturing facility in Bothell, Washington. Seattle Genetics plans to utilize the facility primarily for antibody production for current and future pipeline programs.
ADC Collaborator Milestone: Seattle Genetics achieved a $12 million milestone payment under its ongoing ADC collaboration with AbbVie triggered by AbbVie’s clinical progress with depatuxizumab mafodotin (ABT-414) for patients with glioblastoma. Depatuxizumab mafodotin is an ADC targeting EGFR utilizing Seattle Genetics’ proprietary technology.
ADC Collaborator Progress: Roche announced that polatuzumab vedotin, an ADC utilizing Seattle Genetics’ technology, received Breakthrough Therapy Designation from the FDA and that a phase 3 trial in diffuse large B-cell lymphoma is planned for the fourth quarter of 2017. The ADC was previously granted PRIME (PRIority MEdicines) designation by the European Medicines Agency.
Third Quarter and Nine Months 2017 Financial Results

Total revenues in the third quarter and nine month periods ended September 30, 2017 increased to $135.3 million and $352.6 million, respectively, compared to $106.3 million and $312.9 million from the same periods in 2016. Revenues included:

ADCETRIS net sales in the third quarter of $79.2 million, a 13 percent increase from net sales of $70.1 million in the third quarter of 2016. For the year-to-date, ADCETRIS sales were $223.8 million, compared to $195.0 million for the year-to-date period in 2016, a 15 percent increase.
Royalty revenues in the third quarter of 2017 of $16.7 million, compared to $12.2 million in the third quarter of 2016. For the year-to-date in 2017, royalty revenues were $46.0 million, compared to $53.7 million for the first nine months of 2016. Royalty revenues are primarily driven by international sales of ADCETRIS by Takeda. Royalty revenues in 2016 included a $20.0 million sales milestone payment from Takeda earned in the first quarter of 2016.
Amounts earned under the company’s ADCETRIS and ADC collaborations totaling $39.4 million in the third quarter and $82.8 million for the first nine months of 2017, compared to $24.0 million and $64.1 million, respectively, for the same periods in 2016.
Total costs and expenses for the third quarter of 2017 were $167.5 million, compared to $138.7 million for the third quarter of 2016. For the first nine months of 2017, total costs and expenses were $503.4 million, compared to $399.7 million in the first nine months of 2016. The increase in 2017 costs and expenses was primarily driven by ADCETRIS drug supply provided to Takeda as well as investment in enfortumab vedotin, SGN-LIV1A and the company’s pipeline programs.

Non-cash, share-based compensation cost for the first nine months of 2017 was $47.9 million, compared to $37.0 million for the same period in 2016.

As part of a previously terminated license transaction with Immunomedics, Seattle Genetics holds 3.0 million shares of Immunomedics common stock and a warrant to purchase an additional 8.7 million shares. In September 2017, Immunomedics’ resale registration statement covering the shares issuable upon exercise of the warrant was declared effective by the SEC. As a result, the warrant is accounted for as a derivative security and marked-to-market. This led to a gain of $78.7 million reflected in investment and other income, net, recorded in the quarter ended September 30, 2017.

Due to the gain on the Immunomedics warrant, Seattle Genetics reported net income in the third quarter of 2017 of $50.0 million, or $0.34 per fully diluted share, compared to a net loss of $31.8 million, or $0.23 per share, for the third quarter of 2016. For the nine months ended September 30, 2017, net loss was $66.3 million, or $0.46 per share, compared to a net loss of $85.0 million, or $0.61 per share, for the nine months period ended September 30, 2016.

As of September 30, 2017, Seattle Genetics had $470.4 million in cash, cash equivalents and investments.

2017 Financial Outlook

Seattle Genetics updated its full year 2017 financial guidance as follows:

Current Previous
Revenues from collaboration and license agreements $90 million to $100 million $75 million to $90 million
Royalty revenues $60 million to $65 million $50 million to $55 million
Research and development expenses $460 million to $480 million $460 million to $500 million
Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss its third quarter 2017 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section, or by calling 877-830-2649 (domestic) or 785-424-1824 (international). The conference ID is 4819463. A replay of the discussion will be available beginning at approximately 4:30 p.m. PT today from the Seattle Genetics website or by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 4819463. The telephone replay will be available until 5:00 p.m. PT on Monday, October 30, 2017.