On February 17, 2016, BioInvent reported its Financial Statement for January 1 to December 31 2015 (Press release, BioInvent, FEB 17, 2016, http://www.bioinvent.com/media-centre/press-releases/release/?ReleaseID=A87CE808F590960A [SID:1234509076]).

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Fourth quarter 2015, October – December

Net sales for October-December 2015 amounted to SEK 10 (1.7) million.
Earnings after tax for October-December 2015: SEK -21 (-28) million.
Earnings after tax per share for October-December 2015 before and after dilution: -0.13 (-0.25) SEK.
Cash flow from current operations and investment activities for October-December 2015: SEK -11 (-25) million.

Full year report 2015, January – December
Net sales for January-December 2015 amounted to SEK 16 (47) million.
Earnings after tax for January-December 2015: SEK -91 (-54) million.
Earnings after tax for January- December 2015 before and after dilution: SEK -0.64 (-0.53).
Liquid funds as of 31 December 2015: SEK 40 (46) million. Cash flow from current operations and investment activities for January- December 2015: SEK -73 (-76) million.

Important events in the fourth quarter and after the reporting period
The Board of Directors of BioInvent resolved on 16th of February on a private placement of SEK 43 million to the US-based healthcare investor Omega Funds and a rights issue of SEK 191 million subject to approval by an Extraordinary General Meeting on 18 March 2016. Notice to the General Meeting is published in a separate press release.
BioInvent announced in December 2015 that the company had been selected by a major global pharmaceutical company to provide manufacturing services for one of the products in the pharmaceutical company’s development portfolio. Revenues are expected to amount to approximately SEK 25 million.
In December 2015 BioInvent announced the increased commitment to the BI-505 programme and the submission of a clinical trial application to the US Food and Drug Administration (FDA).
BioInvent announced in December 2015 that it had gained access to novel technology for making highly efficacious immune stimulatory antibodies to combat cancer. This initiative continues BioInvent’s long standing research collaborations with the University of Southampton.
In January BioInvent announced that the FDA had completed the safety review of its Investigational New Drug application for TB-403 and have concluded that the proposed pediatric clinical investigation can proceed.

Comments from the CEO
"In 2015, through collaboration with leading international research groups, charities and patient organizations, BioInvent secured most of the financial and operational resources needed to implement our three clinical programs in Phase I and II with a total of approximately 200 patients. As a result, we have ensured funding for these trials while retaining our ownership and interest in them.

I am now pleased to announce a further significant step forward in the development of BioInvent.
Based on recent progress in our project portfolio, including important scientific publications and the projected initiation of clinical trials in three of our immuno-oncology programs during 2016, BioInvent has attracted considerable interest from international and local health care-investors. From this position of strength, we now intend to create the financial leverage to fully exploit the commercial potential of our key programs.

The MSEK 234 financing round announced yesterday is anchored by a private placement of MSEK 43 to Omega Funds – a US-based healthcare investor, reputable for actively supporting its portfolio companies in creating long-term shareholder value. In parallel, we are offering our current shareholders to participate in a fully guaranteed MSEK 191 rights issue at equal terms. The investors guaranteeing the rights issue are renowned private investors, foundations and institution like investors such, such as LMK, Bengt Sjöberg, Kamprad foundation, Crafoord foundation, Peter Edwall and Laurent Leksell.

Omega Funds will be a welcome addition as shareholders, partly because they make their own team of experts available, but also as BioInvent gains the opportunity to leverage on Omega’s longstanding and strong relationships with major pharmaceutical companies, financial institutions and investors.

The capital from the equity issues is mainly intended to finance BioInvent’s costs related to clinical trials, supporting pre-clinical work aiming to optimize the value of the clinical projects and continued development of the Company’s prioritized pre-clinical projects. In addition, a strengthened financial position enables increased strategic flexibility and improved ability to negotiate with potential partners.

BioInvent has an attractive clinical portfolio in the orphan oncology area; niche categories with significant unmet medical needs. This focus combines a shorter and more cost-effective way to market, while providing an opportunity for reimbursement and rapid uptake of our products. The company’s pre-clinical research in immuno-oncology is of high quality and has gained significant interest from the pharmaceutical industry for collaboration.

All three studies planned to start in 2016, are designed as open, which offers the possibility to monitor results continuously. This increases the opportunities for transparency with the stock market and flexibility in negotiations with future partners in order to maximize shareholder value. BioInvent’s antibody BI-1206 will undergo a Phase I/II trial in patients with non-Hodgkin’s lymphoma and chronic lymphatic leukaemia. Further development will be focused on subgroups with high, unmet medical needs and short time to market. Two of BioInvent’s programs, BI-505 for multiple myeloma and TB-403 in childhood cancer are both orphan drug projects. The trials for these programs are designed to potentially form the basis for registration files, provided that the clinical endpoints are met.

The share issues provide BioInvent with a new large international shareholder, and will enable the company to reach important value inflection points in our key programs over a period of at least two years. I am confident that this major milestone in BioInvent’s development will further increase our ability to deliver significant value to our shareholders in the short and long term," says Michael Oredsson, President and CEO of BioInvent.

On February 16, 2016 Starpharma Holdings Ltd (ASX: SPL, OTCQX: SPHRY) reported its interim report and financial results for the half-year ended 31 December 2015 (Press release, Starpharma, FEB 17, 2016, View Source [SID:1234509077]).

Financial Summary
Reported loss of $10.0M (Dec 2014: $8.5M)
Revenue of $3.7M (Dec 2014: $0.7M)
R&D tax incentives of $1.8M reported in the half-year (Dec 2014: $1.6M)
Cash position at 31 December 2015 of $54.7M (June 2015: $30.8M)
Cash inflows of $7.2M from partners and grants, includes US$2.0M from AstraZeneca and $3.4M R&D tax incentive refund
Proceeds from completion of $32.0M equity placement
Operational Highlights
Signing of a multiproduct drug delivery license with AstraZeneca with potential milestones payments of up to US$126M, plus royalties;
AstraZeneca selected second DEP candidate under the drug delivery license;
EU marketing approval granted for VivaGel BV treatment and the rapid relief of BV including symptoms;
Signing of Memorandum of Understanding to manufacture and sell the VivaGel condom in the Chinese Government sector;
Targeted DEP outperforms leading treatments in ovarian cancer model; and
Additional US patent granted for VivaGel BV with 7 year extension of term.

Starpharma concluded the half-year in a strong financial position with a cash balance of $54.7 million following the $32 million equity placement in the period, with a further $1.9 million received after the period from the closing of a share purchase plan. Cash receipts in the half-year totalled $7.2 million with $3.8 million received from partners, including AstraZeneca, and a further $3.4 million from R&D tax incentives.

The signing of the AstraZeneca DEP drug delivery licence agreement was a major highlight in the period triggering the receipt of the first US$2 million milestone under the multiproduct deal. Under the license, AstraZeneca has selected an oncology compound as the initial DEP candidate which provides for potential development, launch and sales milestones payable to Starpharma of up to US$126 million, plus royalties on net sales. In November AstraZeneca also nominated a second candidate for development, with potential milestones of up to US$93 million, plus royalties.

The net loss after tax for the half-year of $10.0 million reflects investment across the Company’s VivaGel, drug delivery and agrochemical portfolios, including the conduct of two clinical programs in parallel – the VivaGel Phase 3 clinical trials for the prevention of recurrent bacterial vaginosis and the Phase 1 DEPTM docetaxel trial.

The double-blinded, placebo controlled Phase 3 trials of VivaGel for prevention of recurrent bacterial vaginosis are actively enrolling participants across sites in the US, Canada, Mexico, Europe and Asia. Each trial will enrol around 600 women, with more than 75% of total participants enrolled to-date.

The Phase 1 clinical trial of DEP docetaxel in cancer patients, at four Australian sites continues to show very encouraging clinical data with more than 75% of patients having been recruited and administered multiple cycles of treatment. DEP docetaxel has been dosed at levels at and above the most commonly used dose for Taxotere (75mg/m2), with no bone marrow toxicities (including neutropenia) or hair loss reported. Patients treated with DEP docetaxel have also not required anti-nausea or cortisone pre-treatment.

Commenting on the Company’s achievements and outlook, Starpharma CEO Dr Jackie Fairley said:

"During the half year, we achieved several important milestones across our VivaGel, drug delivery and agrochemicals programs, and Starpharma is very well placed financially to build upon these developments in 2016. Within the VivaGel portfolio, the granting of EU marketing approval of VivaGel BV treatment for the rapid relief of bacterial vaginosis and its symptoms, and the signing of a Memorandum of Understanding for the VivaGel condom in the Chinese government sector were important regulatory and commercialisation achievements in the half-year. These achievements, combined with ongoing commercial and regulatory progress and the rollout of the VivaGel condom with existing partners in additional geographies, strengthens VivaGel’s commercial product opportunities.

"In addition to the signing of the AstraZeneca deal and the progress in the DEPTM docetaxel clinical programs, substantial progress has also been made in drug delivery, in both internal and partnered programs. Starpharma has built on its DEP pipeline of potential internal clinical candidates, with compelling pre-clinical results achieved in both DEP carbazitaxel and its novel Targeted DEPTM program, where complete tumour regression and 100% survival was achieved in an ovarian cancer model, significantly outperforming Roche’s currently marketed antibody-drug conjugate, Kadcyla."

"Finally, Starpharma’s agrochemical partnerships have been extended and expanded in scope with existing and new agrochemical companies for the development of Priostar dendrimer-improved crop protection formulations for the European, Asian and North American markets."

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On February 17, 2016 AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a specialty pharmaceutical company with a diverse portfolio of products in the areas of maternal health, anemia management and cancer supportive care, reported unaudited consolidated financial results for the fourth quarter and full year ended December 31, 2015 (Filing, 8-K, AMAG Pharmaceuticals, FEB 17, 2016, View Source [SID:1234509079]).

"2015 was a pivotal year for AMAG as we drove revenue growth of Makena and Feraheme, expanded our presence in maternal health through the acquisition of Cord Blood Registry and made an investment in a promising therapy for the potential treatment of severe preeclampsia," said William Heiden, AMAG’s chief executive officer. "Growing revenues and integrating these transactions, combined with advancing our next generation programs for Makena and Feraheme, have positioned us well for continued strong growth."

Full Year 2015 Business Highlights:

· Increased net product sales of Makena by 52% to $251.6 million, compared with pro forma net product sales of $165.8 million(2) in 2014. This growth in sales was driven by a 56% increase in volume as more at-risk pregnant women were treated with Makena.

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· Made progress toward commercialization of a single-dose, preservative-free formulation of Makena. The company responded to questions contained in the FDA’s complete response letter in November 2015 and anticipates an approval of its manufacturing supplement in the first quarter of 2016 with commercial launch in the second quarter of 2016.

· Advanced the development of the next generation program for Makena with an auto-injector device for subcutaneous administration of Makena through a partnership with Antares Pharma, Inc., an experienced drug device company.

· Expanded the maternal health portfolio through the acquisition of Cord Blood Registry (CBR), the world’s largest private newborn stem cell bank serving pregnant women and their families, and the purchase of an option to acquire worldwide rights to an orphan drug candidate being developed for severe preeclampsia.

· Returned Feraheme (ferumoxytol) to growth in the second half of the year, increasing sales by 5% to $88.5 million in 2015, compared with $84.4 million in 2014.(3)

(1) See summaries of non-GAAP adjustments for the three and twelve months ended December 31, 2015 and 2014 at the conclusion of this press release.
(2) Unaudited. Includes net product sales of Makena as though Lumara Health had been acquired at the beginning of 2014. Lumara Health was purchased on November 12, 2014.

· Initiated start-up activities for a head-to-head, Phase 3 clinical trial evaluating the safety of Feraheme compared to Injectafer (ferric carboxymaltose injection) in adults with iron deficiency anemia (IDA). This study is intended to support an sNDA filing to broaden the use of Feraheme beyond the current chronic kidney disease (CKD) indication to include all adult IDA patients who have failed or cannot tolerate oral iron treatment.

Fourth Quarter Ended December 31, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues for the fourth quarter of 2015 were $108.7 million, compared with $53.3 million for the same period in 2014. Net product sales of Makena were $67.4 million in the fourth quarter of 2015, compared with $22.5 million(4) in the same period last year. Sales of Feraheme and MuGard totaled $23.5 million in the fourth quarter of 2015, compared with $24.5 million in the fourth quarter of 2014, which included a favorable $1.8 million release of product return reserves. Service revenue from CBR totaled $17.0 million in the fourth quarter of 2015.

Total costs and expenses for the fourth quarter of 2015 were $86.1 million, compared with $56.6 million for the same period in 2014. The increase in costs and expenses was primarily due to higher costs associated with managing the company’s expanded portfolio and infrastructure following the acquisitions of Lumara Health in November 2014 and CBR in August 2015.

The company reported operating income of $22.7 million and net income of $7.2 million, or $0.21 per basic share and $0.20 per diluted share, for the fourth quarter of 2015, compared with an operating loss of $3.4 million and net income of $143.0 million, or $5.98 per basic share and $4.67 per diluted share, for the same period in 2014. In the fourth quarter of 2014, the company recognized a non-cash income tax benefit of $153.2 million associated with the release of reserves on certain tax attributes (i.e., net operating losses) as a result of the Lumara Health transaction. The weighted average diluted shares used in calculating diluted net income per share in 2015 and 2014 followed the if-converted method of accounting for the convertible debt.

Financial Results (Non-GAAP Basis)(1),(5)

Non-GAAP revenues totaled $120.6 million, up from $51.0 million in the fourth quarter of 2014. Non-GAAP CBR revenue totaled $28.8 million in the fourth quarter of 2015. The difference between GAAP and non-GAAP revenue for CBR represents purchase accounting adjustments related to deferred revenue.

Total costs and expenses on a non-GAAP basis totaled $59.2 million resulting in a gross margin of 92% and adjusted EBITDA margin of 51% for the fourth quarter of 2015. This compares to costs and expenses of $36.4 million in the same period of 2014, which resulted in a gross margin of 89% and adjusted EBITDA margin of 29%. Non-GAAP adjusted EBITDA for the fourth quarter of 2015 was $61.3 million, compared with $14.5 million for the same period in 2014.

(3) Excludes a favorable $1.8 MM release of product return reserves in 2014.
(4) AMAG purchased Lumara Health maternal health business on November 12, 2014.
(5) See share count reconciliation at the conclusion of this press release.

After deducting cash interest expense, the company generated fourth quarter 2015 non-GAAP cash earnings of $46.5 million, or $1.34 per non-GAAP basic share and $1.12 per non-GAAP diluted share. In the fourth quarter of 2014, non-GAAP cash earnings totaled $10.2 million, or $0.33 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share for the fourth quarter of 2015 includes the impact of the convertible debt and related bond hedge and warrants.

Full Year Ended December 31, 2015 (unaudited)

Financial Results (GAAP Basis)

Total revenues in 2015 were $418.3 million, compared with $124.4 million in 2014. This increase is primarily related to the addition of Makena in November 2014 and CBR in August 2015, which contributed $251.6 million and $24.1 million, respectively, in product revenue to the 2015 results. In addition, the company recognized $52.3 million of collaboration revenue in 2015 related to the company’s ex-US ferumoxytol marketing agreement with Takeda Pharmaceutical Company Limited, compared with $14.4 million of collaboration revenue in 2014. The marketing agreement was terminated in 2015, resulting in the recognition of all previously deferred revenue.

Net income totaled $32.8 million in 2015, compared with $135.8 million in 2014. Basic net income per share was $1.04, compared with $6.06 in 2014. Diluted net income per share was $0.93 in 2015, compared with $5.45 in 2014. In 2014, the company recognized a non-cash income tax benefit of $153.2 million associated with the release of reserves on certain tax attributes (e.g., net operating losses) as a result of the Lumara Health transaction. The weighted average diluted shares used in calculating diluted net income per share in 2015 and 2014 followed the if-converted method of accounting for the convertible debt.

Financial Results (Non-GAAP Basis)(1),(5)

Non-GAAP revenues totaled $397.4 million in 2015, up from $116.2 million in 2014. Non-GAAP CBR revenue totaled $43.3 million since the acquisition in August 2015. Non-GAAP adjusted EBITDA totaled $213.4 million in 2015, compared with $14.3 million in 2014. After deducting cash interest expense, the company generated non-GAAP cash earnings of $173.7 million in 2015, or $4.43 per non-GAAP diluted share. In 2014, non-GAAP cash earnings totaled $7.7 million, or $0.30 per non-GAAP diluted share. The weighted average diluted shares used in calculating the non-GAAP cash earnings per diluted share in 2015 included the impact of the convertible debt and related bond hedge and warrants.

Balance Sheet Highlights

As of December 31, 2015, the company’s cash and investments totaled approximately $466.3 million and total debt (face value) was approximately $1.0 billion.

"The two transformative acquisitions that we completed in the past eighteen months fueled our significant top- and bottom-line growth in 2015, resulting in adjusted EBITDA of more than $210 million in 2015," said Frank Thomas, AMAG’s president and chief operating officer. "These strong cash flows, combined with more than $460 million in cash and investments on the balance sheet, positions us well for future acquisitions that will allow us to leverage our commercial organization and add new, innovative products to our portfolio to drive future growth."

2016 Goals

The company’s goals for 2016 include the following:
· Drive significant net product sales growth (+40%) over 2015

· Grow non-GAAP adjusted EBITDA to more than $255 million

· Continue to execute on the Makena next generation development program, including:

· Receiving a favorable decision from the FDA in 1Q 2016 for the single-dose, preservative-free formulation of Makena with a 2Q 2016 commercial launch

· Completing chemistry, manufacturing and controls (CMC) and pilot pharmacokinetics (PK) work to support the initiation of a bio-equivalence study for the Makena subcutaneous auto injecter by the end of 2016

· Enroll patients in a head-to-head Phase 3 clinical trial in 2016 evaluating the safety of Feraheme compared to Injectafer in adults with IDA

· Complete preclinical work and initiate clinical program for severe preeclampsia Velo option

· Further expand the company’s product portfolio through acquisitions or in-licensing of products or companies

Use of Non-GAAP Financial Measures

AMAG has presented certain non-GAAP financial measures, including non-GAAP revenue, non-GAAP adjusted EBITDA (earnings before income taxes, depreciation and amortization), non-GAAP net income, or

(6) See reconciliation of 2016 financial guidance of non-GAAP CBR revenue, non-GAAP adjusted EBITDA and non-GAAP cash earnings at the conclusion of this press release.

cash earnings, non-GAAP diluted net income, or cash earnings, per share, and non-GAAP weighted average diluted shares. These non-GAAP financial measures exclude certain amounts, revenue, 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.

On February 16, 2016 Advaxis, Inc. (NASDAQ:ADXS), a clinical stage biotechnology company developing cancer immunotherapies, reported that Daniel J. O’Connor, president and chief executive officer, will present an overview of the company’s business strategy and corporate programs at the 2016 RBC Capital Markets Global Healthcare Conference at the New York Palace in New York City (Press release, Advaxis, FEB 16, 2016, View Source [SID:1234509060]). Advaxis’ presentation will take place on Tuesday, February 23 at 11:30 a.m. EST.

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The presentation will provide an update on the Company’s key milestones and initiatives for 2016 including its soon to be launched Phase 3 trial for axalimogene filolisbac for the treatment of high-risk locally advanced cervical cancer (AIM2CERV) and the launch of a Phase 2 trial in metastatic anal cancer (FAWCETT). The presentation will also review Advaxis’ advancing work in neo-epitopes through its partnership with Memorial Sloan Kettering Cancer Center and ongoing work in prostate cancer and with HER2-driven tumors.

On February 16, 2016 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported strong fourth quarter 2015 financial results (Press release, Baxalta, FEB 16, 2016, View Source [SID:1234509062]).

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"We are pleased to report another quarter of strong financial performance reflecting continued positive momentum across our entire portfolio," said Ludwig Hantson, chief executive officer and president, Baxalta. "In 2015, Baxalta achieved its strategic objectives, exceeded our financial guidance with disciplined execution and established a solid foundation for the future. We will continue to build on this success with our commitment to patient-centric innovation and new product launches to drive enhanced growth and value for patients, customers and other key stakeholders."

Financial Results for the Fourth Quarter 2015

In the fourth quarter, Baxalta generated net income on a GAAP basis of $95 million and earnings of $0.14 per diluted share. These results include net after-tax special items totaling $292 million, or $0.43 per diluted share, primarily for intangible asset amortization, expenses associated with the company’s separation from Baxter International (NYSE: BAX), and certain business development and collaboration-related items.

On an adjusted basis, excluding special items, Baxalta reported fourth quarter net income of $387 million, or $0.57 per diluted share, which compares favorably to the company’s previously-issued guidance of $0.55 to $0.57 per diluted share. These financial results reflect positive sales momentum and higher gross margins, providing enhanced flexibility for accelerated investments in research and development, marketing and launch preparedness, and global infrastructure to position the company for future success.

Positive Sales Momentum Across Differentiated Portfolio

In the fourth quarter, Baxalta’s worldwide revenues on a GAAP basis of $1.8 billion advanced 5 percent from the prior-year period. Excluding the impact of foreign currency, sales advanced 12 percent.

On a pro forma basis, worldwide revenues increased 3 percent. Excluding the impact of foreign currency, sales advanced 10 percent, exceeding the company’s previously-issued guidance of growth in the 3 to 5 percent range. Within the United States, sales of $944 million rose 13 percent; international sales of $819 million declined 7 percent. Excluding foreign currency, international sales increased 8 percent.

By business, global hematology revenues of $1.0 billion increased 6 percent (excluding the impact of foreign currency) as the company continues to focus on enhancing access and elevating standards of care worldwide. Growth was driven by the U.S. introduction of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, following U.S. Food and Drug Administration (FDA) approval in November, as well as heightened global demand for ADVATE [Antihemophilic Factor (Recombinant)] and FEIBA [Anti-Inhibitor Coagulant Complex], an inhibitor treatment. Also contributing to performance was growth of RIXUBIS [Coagulation Factor IX (Recombinant)], a treatment for hemophilia B, and OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence], for the treatment of acquired hemophilia A.

Immunology sales of $680 million advanced 8 percent (excluding the impact of foreign currency) on a pro forma basis. The company continues to capitalize on its broad and differentiated portfolio of immunoglobulin therapies, including HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], and is driving strong sales of specialty biotherapeutics.

Baxalta’s new oncology business recorded sales of $53 million in the quarter. This reflects revenues from the recent acquisition of ONCASPAR (pegaspargase), a marketed biologic treatment for acute lymphoblastic leukemia (ALL).

Full-Year 2015 Sales Results

For the full-year 2015, Baxalta reported worldwide revenues on a GAAP basis of $6.1 billion, a 3 percent increase over the prior-year period. Excluding the impact of foreign currency, sales advanced 11 percent.

On a pro forma basis, worldwide revenues grew 2 percent. Excluding the impact of foreign currency, sales advanced 10 percent, exceeding the company’s original expectations and updated projections provided in the third quarter of approximately 8 percent growth. Within the United States, sales of $3.3 billion rose 10 percent, and international sales of $2.9 billion declined 6 percent. Excluding the impact of foreign currency, international sales increased 10 percent.

2015 Highlights and Key Milestone Achievements

Baxalta has established a solid track record of executing its strategic objectives, delivering strong financial performance and achieving meaningful pipeline milestones following its separation from Baxter International in 2015.

"Our relentless quest for innovation is fostering a culture of purpose-driven performance and success," added Hantson. "Baxalta employees around the world are inspired by and committed to meeting patient needs. Our strong momentum will continue to differentiate our businesses in a highly competitive landscape and create sustainable, long-term value."

2015 highlights include:

Launching Baxalta Incorporated as a global biopharmaceutical leader dedicated to patients with orphan diseases and underserved conditions. The separation from Baxter International allowed Baxalta to advance its leadership position and continue innovation on transformative therapies in hematology, immunology and oncology.

Enhancing commercial execution and driving new product revenues of nearly $300 million for the full-year 2015 led by HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] and ONCASPAR, as well as RIXUBIS [Coagulation Factor IX (Recombinant)], OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] and ADYNOVATE.

Expanding the company’s commitment to oncology with the ONCASPAR (pegaspargase) leukemia portfolio acquisition from Sigma-Tau Finanziaria S.p.A., which provided access to ONCASPAR as well as an established commercial and clinical infrastructure. Complementing its oncology focus in orphan diseases, Baxalta also announced a broad strategic immuno-oncology collaboration with Symphogen, a private biopharmaceutical company based in Denmark developing recombinant antibodies and antibody mixtures, to advance novel therapeutics against six checkpoint targets, with the first program expected to enter clinical studies in 2017.

Making significant progress toward Baxalta’s objective of launching approximately 20 new products by 2020 with three key regulatory approvals in 2015, bringing the total number of new products approved in the last 18 months to ten. This includes FDA approval and subsequent launch of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, and FDA approval of VONVENDI [von Willebrand factor (Recombinant)], the first and only recombinant treatment for adults living with von Willebrand Disease (VWD). In addition, Baxalta recently secured European Commission Marketing Authorization of ONCASPAR, which allows Baxalta to market this product in 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway.

Advancing several breakthrough innovations with potential to transform patient care with a number of therapies awaiting regulatory approval, including Baxalta’s investigational 20% subcutaneous immune globulin (IGSC) treatment for primary immunodeficiencies in both the U.S. and Europe, and European approval of ONIVYDE (irinotecan liposome injection) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Progressing early-stage hematology assets with the submission of a Clinical Trial Application to the UK Medicines and Healthcare Products Regulatory Agency to initiate a clinical trial to evaluate the safety and efficacy of BAX 826, an investigational, extended half-life rFVIII treatment for hemophilia A. Baxalta also presented interim data and progress updates at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on the Phase 1/2 study of BAX 335, an investigational factor IX (FIX) gene therapy treatment for hemophilia B, which has been granted orphan designation by the FDA. At the end of 2015, a total of eight patients in three dosing cohorts had been treated.

Expanding Baxalta’s global network of quality manufacturing sites including FDA approval for a state-of-the-art recombinant biologic manufacturing facility in Singapore to produce ADVATE bulk drug substance. Additionally, the European Medicines Agency licensed the manufacturing of HYQVIA and GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] (marketed as KIOVIG in the EU) through the company’s manufacturing services agreement with Stichting Sanquin Bloedvoorziening (Sanquin Blood Supply Foundation or Sanquin) in the Netherlands.

Forming new external partnerships and acquiring novel investigational treatments that complement and build upon our leading and differentiated portfolio. In addition to key oncology and biosimilar partnerships, Baxalta also acquired SuppreMol GmbH’s early-stage development portfolio of biologic immunoregulatory therapeutics for the treatment of autoimmune and IgE-mediated allergic diseases.

Financial Outlook for First Quarter 2016

For the first quarter of 2016, Baxalta expects pro forma sales growth, excluding the impact of foreign currency, of 8 to 9 percent. Including the impact of foreign currency, the company expects pro forma sales to increase 4 to 5 percent. Baxalta also expects first quarter 2016 adjusted earnings, before special items, of $0.44 to $0.46 per diluted share.

The company’s earnings guidance for the first quarter of 2016 excludes approximately $0.03 per diluted share of projected intangible asset amortization expense. Reconciling for the inclusion of this item results in expected GAAP earnings of $0.41 to $0.43 per diluted share for the first quarter of 2016.

Additional Information

Given the proposed merger agreement with Shire plc (LSE: SHP, NASDAQ: SHPG) announced on January 11, 2016, going forward Baxalta will not be hosting an investor conference call to discuss financial results. In addition, as is customary, the company will not be updating its financial guidance for full-year 2016, and previously-issued guidance for Baxalta as a standalone entity is no longer applicable. The transaction, which is subject to customary closing conditions including regulatory approvals in several jurisdictions and approval by both Baxalta’s and Shire’s shareholders, is expected to close mid-2016.

Complementary information related to Baxalta’s fourth quarter and full-year 2015 financial results may be accessed by visiting the Baxalta corporate website at investor.baxalta.com.