On July 23, 2015 Celgene Corporation (NASDAQ:CELG) reported net product sales of $2,254 million for the second quarter of 2015, a 22 percent increase from the same period in 2014 (Press release, Celgene, JUL 23, 2015, View Source [SID:1234506605]). The negative net impact of currency on net product sales was 2 percent. Second quarter total revenue increased 22 percent to $2,278 million compared to $1,873 million in the second quarter of 2014. Adjusted net income for the second quarter of 2015 increased 36 percent to $1,019 million compared to $748 million in the second quarter of 2014. Adjusted diluted earnings per share (EPS) in the second quarter of 2015 was $1.23 which includes a $0.06 gain related to the sale of an equity investment upon completion of their acquisition by another company. For the same period in 2014, adjusted diluted EPS was $0.90.

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Based on U.S. GAAP (Generally Accepted Accounting Principles), Celgene reported second quarter of 2015 net income of $356 million or $0.43 per diluted share. For the second quarter of 2014, net income was $598 million or $0.72 per diluted share.

"The Celgene team delivered exceptional results across the portfolio in the second quarter," said Bob Hugin, Chairman and Chief Executive Officer of Celgene Corporation. "We continue to invest strategically in the long-term future of Celgene and expect our recently announced transactions with AstraZeneca, Juno and Receptos to accelerate our earnings growth beginning in 2019."

Second Quarter 2015 Financial Highlights

Unless otherwise stated, all comparisons are for the second quarter of 2015 compared to the second quarter of 2014. The adjusted operating expense categories presented below exclude share-based employee compensation expense and upfront collaboration payments. Please see the attached Reconciliation of GAAP to Adjusted Net Income for further information.

Net Product Sales Performance

REVLIMID sales for the second quarter increased 19 percent to $1,444 million and were driven by volume in both the U.S. and International markets, increased duration of therapy and continued market share leadership in multiple myeloma. U.S. sales of $873 million and International sales of $571 million increased 22 percent and 15 percent, respectively.

ABRAXANE sales for the second quarter were $244 million, a 13 percent increase. U.S. sales of $170 million and International sales of $74 million increased 6 percent and 34 percent, respectively. The increase in sales reflects volume growth in both the U.S. and Europe driven by increased use in pancreatic cancer.

POMALYST/IMNOVID sales for the second quarter were $235 million, an increase of 46%. U.S. sales were $144 million and International sales were $91 million, an increase of 38% and 60%, respectively. POMALYST/IMNOVID sales were driven by volume increases globally, increasing duration of treatment and share gains, as well as geographic expansion, including the launch in Japan in June.

VIDAZA sales in the second quarter remained flat year-over-year at $152 million. International sales were $146 million, an increase of 3 percent.

OTEZLA sales for the second quarter were $90 million, increasing 49 percent over the first quarter of 2015. U.S. sales were $85 million and International sales were $5 million. OTEZLA uptake and market share gains have been strong in the U.S. since the initial approval in March 2014. Early launch countries in Europe have begun contributing. Prescription trends continue to increase.
All other product sales, which include THALOMID, ISTODAX and an authorized generic of VIDAZA drug product in the U.S., were $89 million in the second quarter of 2015 compared to $98 million for the second quarter of 2014.

Research and Development (R&D)

Adjusted R&D expenses were $477 million for the second quarter of 2015 compared to $397 million for the second quarter of 2014. The increase was primarily due to an increase in clinical trial activity across the portfolio. On a GAAP basis, R&D expenses were $1,110 million for the second quarter of 2015 and $457 million for the same period in 2014 primarily reflecting an increase in upfront collaboration expenses.

Selling, General, and Administrative (SG&A)

Adjusted SG&A expenses were $541 million for the second quarter of 2015 compared to $440 million for the second quarter of 2014. The increase was primarily due to investments in support of the global launches of OTEZLA in psoriasis and psoriatic arthritis and REVLIMID in newly diagnosed multiple myeloma. On a GAAP basis, SG&A expenses were $617 million for the second quarter of 2015 compared to $492 million for the same period in 2014. The increase in GAAP SG&A expenses also included an increase in share-based compensation expense.

Cash, Cash Equivalents, and Marketable Securities

In the second quarter of 2015, Celgene purchased approximately 7.9 million of its shares at a total cost of approximately $902 million. In June, the share repurchase authorization was increased by an additional $4.0 billion. As of June 30, 2015, the Company had approximately $5.1 billion remaining authorization under the stock repurchase program, including the additional $4.0 billion.

Operating cash flow was $284 million in the second quarter of 2015 which included $570 million of upfront payments relating to research and development collaborations. Celgene ended the quarter with approximately $7.5 billion in cash, cash equivalents and marketable securities.

2015 Adjusted EPS Guidance Raised

Total net product sales are expected to be in the range of $9.0 billion to $9.5 billion
REVLIMID net sales are expected to be in the range of $5.6 billion to $5.7 billion
ABRAXANE net sales are expected to be in the range of $1.0 billion to $1.25 billion
Adjusted diluted EPS is expected to be in the range of $4.75 to $4.85, up from the original range of $4.60 to $4.75, an increase of approximately 29% over 2014 adjusted diluted EPS
GAAP diluted EPS is expected to be in the range of $2.17 to $2.46, lowered from the original range of $2.97 to $3.19

Key Accomplishments in First Half of 2015

Hematology

Received approval for REVLIMID for the expanded use in patients newly diagnosed with multiple myeloma in the U.S. and Europe
Presented results from the Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) trial, co-sponsored by Celgene and Roche, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Presented updated overall survival results from the MM-020/IFM 07-01 FIRST trial of REVLIMID in newly diagnosed multiple myeloma (NDMM) at ASCO (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper) annual congress
Initiated enrollment in the phase III ROBUSTTM trial with REVLIMID in diffuse large B-cell lymphoma (DLBCL)
Received approval for POMALYST in Japan for the treatment of relapsed and refractory multiple myeloma (RRMM)
Announced that accelerated approval requirements for POMALYST in the U.S. have been fulfilled and the U.S. label has been updated with overall survival results from MM-003
Announced, in collaboration with partner Acceleron Pharma, plans to initiate a phase III program with luspatercept in beta-thalassemia and myelodysplastic syndromes (MDS) by year-end 2015
Entered into a strategic collaboration with AstraZeneca/MedImmune to develop and commercialize durvalumab for hematologic malignancies and generated a clinical development plan covering multiple indications with trials to initiate by year-end

Oncology

Received approval for ABRAXANE in combination with carboplatin in Europe for first-line non-small cell lung cancer (NSCLC) in adult patients who are not candidates for potentially curative surgery and/or radiation
Collaboration partner OncoMed began enrollment in phase II trials with demcizumab in first-line advanced-stage NSCLC and pancreatic cancer
OncoMed presented data from a phase Ib trial of demcizumab in NSCLC at the European Lung Cancer conference and presented data from a phase I trial with demcizumab in pancreatic cancer and NSCLC at ASCO (Free ASCO Whitepaper)
Multiple trials with ABRAXANE in immune-oncology combinations initiated
Achieved reimbursement for ABRAXANE for pancreatic cancer and NSCLC in key European markets

Inflammation & Immunology

Received approval in Europe for OTEZLA for use in adult patients with moderate-to-severe chronic plaque psoriasis who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light and active psoriatic arthritis who have had an inadequate response or who have been intolerant to disease modifying antirheumatic drugs
Presented data from the phase III LIBERATETM (PSOR-010) trial with OTEZLA at the American Academy of Dermatology
Published data from the phase II (BCT-001) trial of OTEZLA in Behçet’s disease in The New England Journal of Medicine
Achieved the primary endpoint for PSOR-011, a trial to support registration for OTEZLA in Japan
Submitted OTEZLA for approval in Turkey for Behçet’s disease
Achieved primary endpoint in the phase III trial PSA-006 evaluating OTEZLA in TNF-alpha naïve patients
Completed enrollment in AD-001, a phase II trial of OTEZLA in atopic dermatitis
Initiated the registration-enabling endoscopy trial with GED-0301 in Crohn’s disease
Published data from a phase II trial of GED-0301 in Crohn’s disease in The New England Journal of Medicine
Presented post-hoc subgroup analysis from the phase II trial of GED-0301 in active Crohn’s disease at the Digestive Disease Week annual meeting
Received Orphan Drug Designation from the U.S. Food and Drug Administration for GED-0301 for the treatment of pediatric Crohn’s disease
Announced the signing of an agreement to acquire Receptos, Inc. for $232.00 per share, or a total of approximately $7.2 billion, net of cash acquired

Research and Early Development

Filed four Investigational New Drug (IND) applications
Initiated phase I trials with CC-90002 (anti-CD47 antibody) in multiple myeloma and solid tumors
Initiated CC-486 in phase II trials for metastatic breast cancer and nasopharyngeal cancer and a phase I trial for DLBCL
Initiated phase I trial with CC-90003 (selective ERK inhibitor) in relapsed and refractory solid tumors
Initiated phase I trial with CC-90005 (selective PKC theta inhibitor) in healthy volunteers and patients with moderate-to-severe plaque psoriasis
Exercised option to obtain an exclusive license outside the U.S. for Agios’ AG-120
Entered into a joint worldwide development and profit share agreement for Agios’ AG-881 and initiated phase I trial with AG-881 in IDH-1 and/or IDH-2 mutated hematologic malignancies and solid tumors
Announced agreement to acquire privately-held biotechnology company Quanticel Pharmaceuticals Inc.
Announced global collaboration with Lycera that includes an exclusive option to license the company’s portfolio of ex vivo
Entered into a strategic collaboration with Juno Therapeutics to develop and commercialize novel immunotherapies for the treatment of cancer and autoimmune diseases

Key Milestones Expected During the Second Half of 2015

Hematology & Oncology

Regulatory decision on REVLIMID for NDMM in Japan
Submission of REVLIMID for non-del5q MDS in the U.S. and Japan
Complete enrollment in the phase III CONTINUUM trial with REVLIMID for chronic lymphocytic leukemia
Regulatory decision in Europe on REVLIMID for relapsed and refractory mantle cell lymphoma
Opinion from the EU Committee for Medicinal Products for Human Use on VIDAZA for elderly acute myeloid leukemia (AML)
Initiate CC-122 in phase I/II trials in DLBCL
Initiate pivotal program for luspatercept in beta-thalassemia and MDS
Initiate pivotal program for AG-221 in AML with IDH-2 mutation
Inflammation & Immunology

Complete enrollment in registration-enabling endoscopy trial with GED-0301 in Crohn’s disease
Initiate enrollment in the phase III trials of GED-0301 in Crohn’s disease
Initiate enrollment in a phase II trial of GED-0301 in ulcerative colitis
Complete enrollment in a phase II trial with CC-220 in systemic lupus erythematosus
Close acquisition of Receptos

On July 23, 2015 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company, reported unaudited consolidated financial results for the second quarter and year-to-date periods ended June 30, 2015 (Filing, 8-K, AMAG Pharmaceuticals, JUL 23, 2015, View Source [SID:1234506603]). Total revenues for the second quarter of 2015 increased to $123.9 million, compared with $24.8 million in the second quarter of 2014. This increase is primarily related to the addition of Makena (hydroxyprogesterone caproate injection) in November 2014, which contributed $63.6 million in net product sales to the second quarter 2015 results, and the recognition of $39.2 million of collaboration revenue related to the termination of the company’s ex-US ferumoxytol marketing agreement. Net income on a GAAP basis totaled $33.3 million, or $0.82 per diluted share(1) for the second quarter of 2015. Non-GAAP net income, or cash earnings(2), for the second quarter of 2015 totaled $44.8 million, or $1.12 per diluted share, compared with $0.6 million, or $0.03 per diluted share, for the same period in 2014.

"We continue to deliver strong financial performance by driving product sales growth, including Makena, which grew more than 58% in the quarter compared to the same quarter last year, and by identifying and executing on new business development opportunities," said William Heiden, chief executive officer of AMAG. "We recently announced our plan to acquire Cord Blood Registry (CBR), and we also purchased an option for the rights to a development program for the treatment of severe preeclampsia, an area of significant unmet need among at-risk pregnant women. Both of these transactions further our commitment to helping pregnant women and their families and strengthens our efforts to collaborate with the maternal health community. In addition to providing future avenues of growth for AMAG, we also expect these acquisitions to add new capabilities to our organization that can be leveraged across our current and future product lines."

(1) See share count reconciliation at the conclusion of this press release.
(2) See summaries of non-GAAP adjustments to reconcile GAAP Consolidated Statements of Operations to Non-GAAP Consolidated Statements of Operations for the three and six month periods ended June 30, 2015 and 2014 at the conclusion of this press release.

2Q15 Business Highlights and Recent Developments

· Net product sales increased to $84.7 million in the second quarter of 2015, compared to $22.5 million in the corresponding period in 2014. This increase was driven by record sales of Makena in the quarter ended June 30, 2015.

· The company delivered record earnings in the second quarter of 2015, including operating income on a GAAP basis of $61.1 million, compared with $1.2 million for the same period in 2014. On a non-GAAP basis, adjusted EBITDA grew to $52.1 million, compared with $1.6 million in the second quarter of 2014(2).

· Makena achieved significant market share growth, increasing four percentage points over the first quarter of 2015 (to an estimated 32% share of patients) and continued to take share from compounded product.

· Feraheme (ferumoxytol) injection sales declined eight percent in the second quarter of 2015, as compared to the corresponding period in 2014 to $20.6 million as the company implemented label changes to the package insert in March 2015.

· The company continued to advance its lifecycle management program for Makena, including the submission of a prior approval supplement with the FDA for the manufacture of a single-dose, preservative-free formulation of Makena by Hospira, Inc., the current manufacturer of the company’s multi-dose vial.

· The company announced that it entered into a definitive agreement to acquire CBR, the world’s largest stem cell collection and storage company serving pregnant women and their families, for $700 million in cash. The transaction will further diversify AMAG’s revenue base, expand the size of its obstetrician-focused sales team, and add new consumer-directed sales and marketing capabilities. The transaction is forecasted to be immediately accretive to adjusted EBITDA and earnings and is expected to close in the third quarter of 2015.

· The company entered into an option agreement with Velo Bio, LLC (Velo), which includes an upfront payment of $10 million to acquire the global rights to an orphan drug candidate being developed for use in the treatment of severe preeclampsia in pregnant women. The option to acquire the program can be exercised at the conclusion of an upcoming Phase 2b/3a clinical study. This transaction further expands AMAG’s maternal health portfolio and advances the company’s strategy of adding differentiated products in growing specialty markets.

Second Quarter Ended June 30, 2015 Financial Results (unaudited)

Total revenues for the second quarter of 2015 were $123.9 million, compared with $24.8 million for the same period in 2014. This increase is primarily related to the addition of Makena, which contributed $63.6 million to net product sales in the second quarter, as well as the recognition of $39.2 million of collaboration revenue related to the termination of the company’s ex-US ferumoxytol marketing agreement with Takeda Pharmaceutical Company Limited (Takeda), which included cash of $5.6 million recorded as revenue during the quarter related to termination and royalty payments and the recognition of $33.6 million representing all remaining Takeda-related previously deferred revenues.

Net product sales for the second quarter of 2015 totaled $84.7 million, compared with $22.5 million in the second quarter of 2014. Sales of Makena in the second quarter of 2015 totaled $63.6 million, representing an increase of 58 percent from $40.3(3) million of Makena sales for the same period in 2014. Sales growth of Makena was driven by increasing volume, as more clinically indicated pregnant women, including those covered by commercial insurance plans as well as Medicaid, were prescribed Makena therapy to reduce their risk of preterm birth. Makena’s volume increased across all distribution channels, including compounding pharmacies that now dispense Makena instead of compounded hydroxyprogesterone caproate. The conversion of Makena compounders into distributors is our fastest growing channel and accounted for approximately 16 percent of Makena’s second quarter sales, compared with three percent in the second quarter of 2014.(3) In the company’s hematology/oncology and hospital business, Feraheme net product sales declined eight percent to $20.6 million in the second quarter of 2015, compared with $22.2 million for the same period in 2014. The decline in Feraheme sales was partially a result of recent changes to the product’s label that included adding a boxed warning. Prescription volume of Feraheme in the second quarter of 2015 increased over the first quarter of 2015 and was down slightly from the second quarter of 2014 with the market share loss partially offset by growth of the overall intravenous (IV) iron market. The company anticipates that sales of Feraheme will return to growth in the second half of the year driven by expected continued growth in the overall IV iron market and forecasted future price appreciation.

Total operating expenses, excluding cost of product sales, for the second quarter of 2015 were $43.1 million, compared with $20.8 million for the same period in 2014. The increases in operating expenses were primarily due to costs related to the Lumara acquisition and costs associated with managing the company’s expanded product portfolio. During the second quarter, the company incurred approximately $2.7 million related to certain acquisition-related costs associated with the CBR transaction announced in June 2015.

The company reported net income of $33.3 million, or $1.09 per basic share and $0.82 per diluted share(1), for the second quarter of 2015, compared with net loss of $1.5 million, or ($0.07) per basic and diluted share, for the same period in 2014. The weighted average diluted shares used in calculating diluted net income per share for the second quarter of 2015 followed the if-converted method of accounting for the convertible debt.

Non-GAAP adjusted EBITDA for the second quarter of 2015 was $52.1 million, compared with $1.6 million for the same period in 2014. After deducting cash interest expense, the company generated non-GAAP cash earnings of $44.8 million, or $1.12 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share for the second quarter of 2015 followed the treasury stock method of accounting for the convertible debt and related warrants.(2)

As of June 30, 2015, the company’s cash and investments totaled approximately $398.4 million and debt (face value) totaled $523.0 million.

"The second quarter momentum built off an already strong start to 2015," said Frank Thomas, president and chief operating officer of AMAG. "Our business continues to generate significant positive cash flow and earnings. We believe that the CBR transaction will allow us to further diversify our portfolio and achieve even greater financial flexibility as we pursue additional business development transactions."

Six Months Ended June 30, 2015 Financial Results (unaudited)

Net product sales for the six months ended June 30, 2015 were $162.1 million, compared with $40.0 million for the same period in 2014.

On a GAAP basis, net income for the first six months of 2015 totaled $46.2 million, compared with a net loss of $8.6 million for same period in 2014. GAAP basic earnings per share were $1.60(1), compared with ($0.40) in 2014. GAAP diluted earnings per share were $1.23, compared with ($0.40) in 2014. The weighted average diluted shares used in calculating diluted net income per share for the first half of 2015 followed the if-converted method of accounting for the convertible debt.

Non-GAAP adjusted EBITDA for the six months ended June 30, 2015 was $99.5 million, compared with a loss of $2.1 million for the same period in 2014. After deducting cash interest expense, the company generated non-GAAP cash earnings of $84.5 million, or $2.27 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share followed the treasury stock method of accounting for the convertible debt and related warrants.(2)

Updating 2015 Financial Outlook

The company is updating its 2015 guidance to reflect the business performance for the first half of 2015 and the outlook for the business for the remainder of 2015, including expectations of continued strong management of operating expenses. The guidance below does not include any expected revenue or expenses related to the acquisition of CBR, which is expected to close in the third quarter of 2015 and be immediately accretive to adjusted EBITDA and cash earnings, or the impact of the option agreement with Velo. The company will provide further guidance for the combined business later this year.

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Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a conference call and webcast with slides today at 8:00 a.m. ET, during which management will discuss the company’s financial results and growth prospects. To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 11:00 a.m. ET on July 23, 2015 through midnight on July 30, 2015. To access a replay of the conference call, dial (855) 859-2056 from the United States or (404) 537-3406 for international access. The pass code for the live call and the replay is 81280898.

The call will be webcast with slides and accessible through the Investors section of the company’s website at www.amagpharma.com. The webcast replay will be available from approximately 11:00 a.m. ET on July 23, 2015 through midnight on August 21, 2015.

Use of Non-GAAP Financial Measures

AMAG has presented certain non-GAAP financial measures, including non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization), non-GAAP net income or cash earnings and non-GAAP diluted earnings per share. These non-GAAP financial measures exclude certain amounts, expenses or income, from the corresponding financial measures determined in accordance with accounting principles generally accepted in the U.S. (GAAP). Management believes this non-GAAP information is useful for investors, taken in conjunction with AMAG’s GAAP financial statements, because it provides greater transparency regarding AMAG’s operating performance. Management uses these measures, among other factors, to assess and analyze operational results and trends and to make financial and operational decisions. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of AMAG’s operating results as reported under GAAP, not as a substitute for GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. The determination of the amounts that are excluded from non-GAAP financial measures is a matter of management judgment and depends upon, among other factors, the nature of the underlying expense or income amounts. Reconciliations between these non-GAAP financial measures and the most comparable GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements.

Summary:

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2015 Second Quarter Results

Total Revenue $2.7 billion; an increase of 34% over the prior year
Excluding negative impact of foreign exchange ($173 million) and the contribution of Salix ($313 million), revenue increased 27% over the prior year
Same Store Sales Organic Growth was 19%, driven by:
U.S. businesses, driven by the strength of dermatology, contact lenses, dental and Obagi
Emerging markets including China, the Middle East/North Africa, and Russia
GAAP EPS Loss of $0.15; Cash EPS $2.56
Excluding negative impact of foreign exchange ($0.13) and the negative contribution of Salix ($0.04) , Cash EPS would have been $2.73, a growth rate of 43%
GAAP Operating Cash Flow $411 million; Adjusted Operating Cash Flow $773 million
Excluding Salix, GAAP Operating Cash Flow $714 million
Salix Revenue was $313 million
Strong Xifaxan script uptake following IBS-D approval
Salix wholesaler inventory levels reduced from 4-5 months to 3-3.5 months

Continued Progress of R&D pipeline

New Drug Application (NDA) submitted for RELISTOR (methylnaltrexone bromide) Tablets
NDA submitted for VESNEO (latanoprostene bunod ophthalmic solution) 0.024%

Full Year 2015 Guidance Update

Increasing 2015 Total Revenue to $10.7 – $11.1 billion up from $10.4 – $10.6 billion
Salix revenue expected to be ~$1.2 billion
Increasing 2015 Cash EPS to $11.50 – $11.80 per share up from $10.90 – $11.20 to reflect continued business outperformance and approval of IBS-D indication for Xifaxan
Increasing Adjusted Cash Flow from Operations to greater than $3.2 billion, up from greater than $3.1 billion
Expect Same Store Sales Organic Growth of >10% for second half of 2015

Third Quarter 2015 Guidance

Total Revenue $2.6 – $2.8 billion
Cash EPS $2.60 – $2.70 per share

Fourth Quarter 2015 Guidance

Total Revenue $3.2 – $3.4 billion
Cash EPS $3.98 – $4.18 per share

On July 23, 2015 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) reported second quarter financial results for 2015(Press release, Valeant, JUL 23, 2015, http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Valeant-Pharmaceuticals-Reports-Second-Quarter-2015-Financial-Results/default.aspx [SID:1234506602]) .

"We once again exceeded our guidance and delivered our fourth consecutive quarter of greater than 15% organic growth," stated J. Michael Pearson, chairman and chief executive officer. "Our strong second quarter results were driven by outperformance in our U.S. businesses, strong results in certain emerging markets and outstanding starts to both the Salix and Dendreon acquisitions. In addition, we have signed eight new transactions so far this year and have realized several significant R&D milestones, including the approval of Xifaxan for IBS-D and the NDA submissions for Vesneo and Relistor Oral. As a result, we feel confident in raising our guidance for the remainder of 2015."

On July 23, 2015 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), reported the peer-reviewed publication of data verifying the Lymphoseek (technetium Tc 99m tilmanocept) injection CD206-binding mechanism of action in the Journal of Immunology (Press release, Navidea Biopharmaceuticals, JUL 23, 2015, View Source;p=RssLanding&cat=news&id=2070455 [SID:1234506601]). Strong evidence-based studies demonstrate macrophages are the major target cell and identify CD206, the mannose receptor, as the tilmanocept-binding receptor. CD206 is highly expressed on the surface of tissue macrophages that are known to reside in the sentinel lymph nodes (SLN) draining a primary tumor. Lymphoseek was specifically designed to provide clinicians with a tool to reliably and accurately locate the SLNs which have the highest likelihood of containing metastasized cancer cells and to aid effective cancer staging and inform post-surgical treatment.

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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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"In our studies, we provide evidence that tilmanocept is the first receptor-targeted cancer prognostic agent which is bound by the mannose receptor as well as evidence of the potential mechanism underlying the utility of tilmanocept. In particular we demonstrate the specificity of binding, the tightness of binding and the strong correlation of tilmanocept-binding to macrophages found in sentinel lymph node tissue," said Larry S. Schlesinger M.D. with the Center for Microbial Interface Biology, Department of Microbial Infection and Immunity at The Ohio State University Wexner Medical Center and PI of the study. "In practice this means the molecular nature of tilmanocept allows it to rapidly enter into lymphatic channels, localize in tumor-draining lymph nodes and bind to target receptor(s) for longer retention in these SLNs giving it the required characteristics for a potentially ideal agent for SLN mapping."

"This publication highlights data from rather elegant experiments which confirm our belief that tilmanocept binds primarily to macrophages found in the sentinel lymph nodes of cancer patients and demonstrating its utility in identifying these SLNs," said Frederick O. Cope, Ph.D. FACN, Navidea’s Chief Scientific Officer. "These results provide Lymphoseek with a clear clinical differentiation from other non-targeted procedures and enable additional opportunities for designing receptor-targeted, advanced imaging agents and future potential for the delivery of therapeutics for cancer and other macrophage-dependent diseases."

Lymphoseek is a receptor-targeted imaging agent that was approved by the U.S. Food and Drug Administration (FDA) for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma and squamous cell carcinoma of the oral cavity as well as for lymphatic mapping in patients with solid tumors for which this procedure is a component of intraoperative management. In these procedures, key lymph nodes adjacent to a primary tumor, that may contain tumor metastases, are identified and biopsied to determine if cancer has spread to these lymph nodes.

Summary of Results

A series of studies examined the receptor(s) for tilmanocept. Using complementary approaches including competitive binding, siRNA, Sentinel Lymph Node histochemistry and flow cytometry, the data show that tilmanocept binds predominantly to human macrophages and that the mannose receptor (CD206) is the major receptor for its recognition. The authors conclude that this provides evidence for a potential mechanism underlying the utility of tilmanocept as a sensitive detector of lymph nodes that have the highest likelihood of containing cancer cells if metastasis has occurred. For complete details of the studies, findings and results, "γ-Tilmanocept, a New Radiopharmaceutical Tracer for Cancer Sentinel Lymph Nodes, Binds to the Mannose Receptor (CD206)" is published as an online article in the Journal of Immunology’s "Next in the JI". (J Immunol 140200; published ahead of print July 22, 2015, doi:10.4049/jimmunol.14020050)

About Lymphoseek

Lymphoseek (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM

On July 23, 2015 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the second quarter of 2015, which were highlighted by strong global sales, key regulatory and clinical advances for Opdivo and significant clinical data on the company’s Immuno-Oncology portfolio presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (Press release, Bristol-Myers Squibb, JUL 23, 2015, View Source [SID:1234506597]).

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"We had a very good quarter, with strong sales across our portfolio, encouraging results from clinical trials and important regulatory milestones," said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. "I am excited by our progress in Immuno-Oncology as we continue to advance our leadership position and transform cancer treatment. As our Immuno-Oncology data continues to emerge, it is clear we have a tremendous opportunity, and we are making the right strategic investments to capitalize on the full potential of our portfolio."

SECOND QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted second quarter 2015 revenues of $4.2 billion, an increase of 7% compared to the same period a year ago. Global revenues increased 16% adjusted for foreign exchange impact.

U.S. revenues decreased 3% to $1.8 billion in the quarter compared to the same period a year ago. International revenues increased 17%.

Gross margin as a percentage of revenues was 75.7% in the quarter compared to 74.5% in the same period a year ago.
Marketing, selling and administrative expenses increased 2% to $968 million in the quarter.
Advertising and product promotion spending decreased 11% to $167 million in the quarter.
Research and development expenses increased 31% to $1.9 billion in the quarter, primarily due to the acquisition of Flexus Biosciences, Inc.

The effective tax rate was 311.5% in the quarter, compared to 25.4% in the second quarter last year.
The company reported net loss attributable to Bristol-Myers Squibb of $130 million, or $0.08 per share, in the quarter compared to net earnings of $333 million, or $0.20 per share, a year ago. The results in the current quarter include an $800 million R&D charge ($0.48 per share) resulting from the Flexus acquisition, which was not deductible for tax purposes.

The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $890 million, or $0.53 per share, in the second quarter, compared to $798 million, or $0.48 per share, for the same period in 2014. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.

Cash, cash equivalents and marketable securities were $10.1 billion, with a net cash position of $2.7 billion, as of June 30, 2015.

SECOND QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the second quarter included Eliquis, which grew by $266 million, Orencia, which grew 15%, Sprycel, which grew 10%, and Opdivo, which had sales of $122 million. Daklinza and Sunvepra had combined sales of $479 million, which includes $170 million of previously deferred revenue in France as part of an early access program before final pricing was obtained.

Opdivo

In July, the European Medicines Agency (EMA) validated two of the company’s type II variation applications, which seek to extend the current indication for Opdivo. Validation of the applications confirms that the submissions are complete and starts the EMA’s centralized review process. In lung cancer, the proposed new indication addresses the non-squamous, NSCLC population and is based on data from the Phase 3 CheckMate -057 study: Opdivo as monotherapy for the treatment of locally advanced or metastatic non-squamous NSCLC after prior chemotherapy in adults. In melanoma, the proposed new indication aims at extending the use of Opdivo monotherapy in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults and is based on data from the Phase 3 CheckMate -067 study, Phase 2 CheckMate -069 study and the Phase 1b CA209-004 study.

In July, the European Commission (EC) approved Nivolumab BMS for the treatment of locally advanced or metastatic squamous NSCLC after prior chemotherapy. This approval marks the first major treatment advance in squamous NSCLC in more than a decade in the European Union (EU). Nivolumab is the first and only PD-1 immune checkpoint inhibitor to demonstrate overall survival in previously treated metastatic squamous NSCLC. This approval allows for the marketing of nivolumab in all 28 Member States of the EU.

In July, the company announced that an open-label, randomized Phase 3 study evaluating Opdivo versus everolimus in previously treated patients with advanced or metastatic renal cell carcinoma (CheckMate -025) was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon.

In June, the EC approved Opdivo for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. Opdivo is the first PD-1 immune checkpoint inhibitor to have received EC approval, which allows Opdivo to be marketed in all 28 Member States of the EU.

In June, the U.S. Food and Drug Administration (FDA) accepted for filing and review the supplemental Biologics License Application (sBLA) for the Opdivo+Yervoy regimen in patients with previously untreated advanced melanoma, the first regulatory milestone for an immuno-oncology combination regimen in cancer. The FDA also granted Priority Review for this application, which includes data from CheckMate -069. The projected FDA action date is September 30, 2015.

In May, during ASCO (Free ASCO Whitepaper) in Chicago, the company announced results from three Phase 3 trials for

Opdivo:
CheckMate -057 – In this study evaluating previously treated patients with advanced non-squamous NSCLC, Opdivo became the first PD-1 immune checkpoint inhibitor to demonstrate superior overall survival versus standard of care (docetaxel). A 27% reduction in the risk of progression or death – the primary study endpoint – was reported for Opdivo versus docetaxel. Opdivo was associated with a doubling of overall median survival across the continuum of PD-L1 expression, starting at 1% level of expression. The safety profile of Opdivo in CheckMate -057 was favorable versus docetaxel with grade 3-5 treatment-related adverse events reported in 10% of patients who were treated with Opdivo versus 54% in the docetaxel arm.

CheckMate -017 – In this open-label, randomized study evaluating Opdivo versus docetaxel in previously treated patients with advanced squamous NSCLC, Opdivo demonstrated an overall survival rate of 42% at one year versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. Opdivo reduced the risk of death by 41%. The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. The results were published in The New England Journal of Medicine (NEJM).

CheckMate -067 – In this study evaluating the Opdivo+Yervoy regimen and Opdivo monotherapy versus Yervoy monotherapy in patients with previously untreated advanced melanoma, both the Opdivo+Yervoy regimen and Opdivo monotherapy demonstrated superiority to Yervoy, the current standard of care, for the co-primary endpoint of progression-free survival (PFS). Median PFS was 11.5 months for the Opdivo+Yervoy regimen and 6.9 months for Opdivo monotherapy, versus 2.9 months for Yervoy monotherapy. The Opdivo+Yervoy regimen demonstrated a 58% reduction in the risk of disease progression versus Yervoy, while Opdivo monotherapy demonstrated a 43% risk reduction versus Yervoy monotherapy. The trial is ongoing and patients continue to be followed for overall survival, a co-primary endpoint.

Also at ASCO (Free ASCO Whitepaper), the company announced results from an interim analysis of CA209-040, a Phase 1-2 dose-ranging trial evaluating the safety and anti-tumor activity of Opdivo in previously treated patients with hepatocellular carcinoma or advanced liver cancer. The estimated survival rate in evaluable patients receiving Opdivo was 62% at 12 months. Results also show the safety profile of Opdivo is generally consistent with that previously reported for Opdivo in other tumor types.

In April, the FDA accepted for filing and review an sBLA for Opdivo for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is August 27, 2015.

Yervoy

The company announced today that two Yervoy Phase 3 trials, Study -095 in metastatic castration-resistant prostate cancer and Study -156 in newly diagnosed extensive-stage disease small cell lung cancer, did not meet their primary endpoints of overall survival versus standard of care and have been discontinued. No new safety concerns with Yervoy were identified in either study. The company will complete a full evaluation of the data and work with investigators on the future publication of the results.
In July, the Japanese Ministry of Health, Labour and Welfare approved Yervoy for first- and second-line treatment of unresectable malignant melanoma.

Elotuzumab

In June, during ASCO (Free ASCO Whitepaper) and the European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Vienna, the company announced results from an interim analysis of ELOQUENT-2, a Phase 3, randomized, open-label trial that evaluated elotuzumab, an investigational immunostimulatory antibody, in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone for the treatment of relapsed or refractory multiple myeloma. The study showed a 30% reduction in the risk of disease progression or death and a two-year PFS rate of 41% in the elotuzumab arm versus 27% in the control arm, respectively. Results also showed minimal incremental adverse events with the addition of elotuzumab to lenalidomide and dexamethasone. These results validate elotuzumab’s novel mechanism of action of directly activating the immune system in patients with relapsed or refractory multiple myeloma and were published in NEJM.

In June, at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper), the company also announced results from a randomized Phase 2 study that evaluated elotuzumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma which, consistent with ELOQUENT-2, demonstrated a 28% reduction in the risk of disease progression or death.

Eliquis

In June, at the International Society on Thrombosis and Haemostasis Congress in Toronto, the company, its partner Pfizer, and Portola Pharmaceuticals announced full results from the second part of ANNEXA-A, a Phase 3, registration-enabling study evaluating the safety and efficacy of andexanet alfa, an investigational antidote and FDA-designated breakthrough therapy, administered as an intravenous bolus followed by a continuous two-hour infusion to sustain the reversal of anticoagulation activity of Eliquis in healthy volunteers ages 50-75 years. Andexanet alfa produced rapid reversal of the anticoagulant effect of Eliquis – as measured by anti-Factor Xa activity, which was sustained for the duration of the infusion – and significantly reduced the level of free unbound Eliquis in the plasma and restored thrombin generation to normal.

HIV

In July, the FDA granted Breakthrough Therapy Designation to the investigational compound BMS-663068, a first-in-class HIV-1 attachment inhibitor, when used in combination with other antiretroviral agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients.

In July, at the 8th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, the company announced additional Phase 2a proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir (± ritonavir) and support further development of the second-generation HIV-1 maturation inhibitor.

Reyataz

In June, the FDA granted pediatric exclusivity for Reyataz, providing an additional six-month period of exclusivity in the U.S.
Daklinza

In May, the FDA amended a previously granted Breakthrough Therapy Designation for the investigational combination of daclatasvir and sofosbuvir for use in hepatitis C (HCV) patients. The updated Designation reflects data from ALLY-1, a Phase 3 study of HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. The data were presented at The International Liver Congress in Vienna, Austria. Daclatasvir is marketed as Daklinza in Japan and the EU.

Evotaz

In July, the EC approved Evotaz tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. The approval allows for the marketing of Evotaz in all 28 Member States of the EU.

Nulojix

In May, during the American Transplant Congress in Philadelphia, the company presented results from a seven-year, long-term follow-up of BENEFIT, a prospective, randomized Phase 3 trial in kidney transplant patients. The study demonstrated a statistically significant 43% relative risk reduction of death or graft loss (transplant failure) in patients receiving the Nulojix FDA-approved dosing regimen over those receiving a cyclosporine regimen. There also was a statistically significant survival benefit of 52% relative risk reduction of death or graft loss at five years post-transplant among patients receiving the Nulojix regimen. In the long-term follow-up (years 3-7) on BENEFIT participants, the safety profile of the Nulojix regimen was similar to the cyclosporine regimen.
ANNEXA is a trademark of Portola Pharmaceuticals, Inc.

SECOND QUARTER BUSINESS DEVELOPMENT UPDATE

In July, the company and The Medical University of South Carolina announced a translational research collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis. The collaboration will include studies designed to improve the mechanistic understanding of fibrosis, explore patient segmentation based on disease characteristics and/or biomarker approaches and predictors of disease progression.

2015 FINANCIAL GUIDANCE

Bristol-Myers Squibb is increasing its 2015 GAAP EPS guidance range from $0.96 – $1.06 to $1.02 – $1.12. The company is also increasing its non-GAAP EPS guidance range from $1.60 – $1.70 to $1.70 – $1.80. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2015. Key revised 2015 non-GAAP line-item guidance assumptions include:

Worldwide revenues between $15.5 and $15.9 billion.
Full-year gross margin as a percentage of revenues of approximately 76%.
Advertising and promotion expense increasing in the high-single-digit range.
Marketing, sales and administrative expenses decreasing in the low- to mid-single-digit range.
Research and development expenses increasing in the mid-single-digit range.
An effective tax rate of approximately 19%.
The financial guidance for 2015 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 2015 guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.

Use of Non-GAAP Financial Information

This press release contains non-GAAP financial measures, including non-GAAP earnings and related earnings per share information. These measures are adjusted to exclude certain costs, expenses, significant gains and losses and other specified items. Among the items in GAAP measures but excluded for purposes of determining adjusted earnings and other adjusted measures are: restructuring and other exit costs; accelerated depreciation charges; IPRD and asset impairments; charges and recoveries relating to significant legal proceedings; upfront, milestone and other payments for in-licensing or acquisition of products that have not achieved regulatory approval which are immediately expensed; pension settlement charges; significant tax events and additional charges related to the Branded Prescription Drug Fee. This information is intended to enhance an investor’s overall understanding of the company’s past financial performance and prospects for the future. Non-GAAP financial measures provide the company and its investors with an indication of the company’s baseline performance before items that are considered by the company not to be reflective of the company’s ongoing results. The company uses non-GAAP gross profit, non-GAAP marketing, selling and administrative expense, non-GAAP research and development expense, and non-GAAP other income and expense measures to set internal budgets, manage costs, allocate resources, and plan and forecast future periods. Non-GAAP effective tax rate measures are primarily used to plan and forecast future periods. Non-GAAP earnings and earnings per share measures are primary indicators the company uses as a basis for evaluating company performance, setting incentive compensation targets, and planning and forecasting of future periods. This information is not intended to be considered in isolation or as a substitute for financial measures prepared in accordance with GAAP.