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Baxalta Declares Quarterly Dividend

On february 23, 2016 The Board of Directors of Baxalta Incorporated (NYSE: BXLT) reported a quarterly cash dividend of $0.07 per share of common stock (Press release, Baxalta, FEB 23, 2016, View Source [SID:1234509188]). The quarterly dividend will be paid on April 1, 2016, to stockholders of record as of the close of business on March 10, 2016.

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8-K – Current report

On February 23, 2016 Shire plc (LSE: SHP, NASDAQ: SHPG) (the "Company") reported on February 11, 2016, an interim dividend of 22.16 US cents per Ordinary Share payable on April 12, 2016, to shareholders on the register of members at the close of business on March 11, 2016 (Filing, 8-K, Shire, FEB 23, 2016, View Source [SID:1234509169]).

Shareholders are advised that recent developments in global tax law, namely the introduction of the Foreign Account Tax Compliance Act and the Common Reporting Standard, have introduced new reporting obligations relating to the Company’s Income Access Share arrangements ("IAS Arrangements"). These require that certain information relating to shareholders participating in the IAS Arrangements is reported to the appropriate tax authorities. In order to ensure the new reporting obligations are met, the Company is requesting from electing (or deemed electing) shareholders the relevant information via new IAS Arrangements election forms (and continuation forms in respect of joint holders). The relevant IAS Arrangements election forms together with an explanatory covering letter were posted to shareholders on February 16, 2016. In accordance with Listing Rule 9.6.1R, these documents were also uploaded to the National Storage Mechanism and are available for viewing. Internet links to the documents are also available on the Company’s website: www.shire.com

All shareholders who wish to receive, or continue to receive, UK sourced dividends via the IAS Arrangements (and therefore without incurring Irish dividend withholding tax) need to complete the new IAS Arrangements election forms and return to the address stated therein.

In order for submitted IAS Arrangements election forms to be valid in respect of the dividend to be paid on April 12, 2016, they need to be received by the Company’s Registrar, Equiniti, by 5pm (UK time) on March 11, 2016. Election forms received after this date will not be applied to this dividend though will be applied to future dividend payments.

Shareholders who do not elect to receive UK sourced dividends using the new IAS Arrangements election forms are advised that their dividends will be Irish sourced and therefore incur Irish dividend withholding tax, subject to applicable exemptions. If you are in any doubt as to what action to take, please consult your tax advisor immediately.

8-K – Current report

On February 23, 2016 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the full year and the fourth quarter of 2015 and provided financial guidance for 2016 (Filing, 8-K, Jazz Pharmaceuticals, FEB 23, 2016, View Source [SID:1234509162]).

"In 2015, we delivered solid growth on the top- and bottom-line while increasing investment in new growth opportunities for our current products and our promising R&D pipeline," said Bruce C. Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals plc. "We look forward to 2016 as we focus on delivering growth of our key commercial products, preparing for our planned launch of defibrotide in the U.S., reaching important clinical milestones, including completing enrollment and determining preliminary results of our JZP-110 Phase 3 safety and efficacy studies, and potentially expanding our commercial and development portfolio through corporate development activities."

Adjusted net income attributable to Jazz Pharmaceuticals plc for 2015 was $600.1 million, or $9.52 per diluted share, compared to $520.5 million, or $8.31 per diluted share, for 2014. Adjusted net income attributable to Jazz Pharmaceuticals plc for the fourth quarter of 2015 was $163.5 million, or $2.60 per diluted share, compared to $151.1 million, or $2.40 per diluted share, for the fourth quarter of 2014.

GAAP net income attributable to Jazz Pharmaceuticals plc for 2015 was $329.5 million, or $5.23 per diluted share, compared to $58.4 million, or $0.93 per diluted share, for 2014. GAAP net income attributable to Jazz Pharmaceuticals plc for the fourth quarter of 2015 was $82.8 million, or $1.32 per diluted share, compared to $81.6 million, or $1.30 per diluted share, for the fourth quarter of 2014. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included in this press release.

2015 Revenues and Product Sales
Total revenues for the year ended December 31, 2015 were $1,324.8 million, an increase of 13% over total revenues of $1,172.9 million for the year ended December 31, 2014. Total revenues for the fourth quarter of 2015 were $340.9 million, an increase of 4% over total revenues of $328.1 million for the fourth quarter of 2014. The increase in total revenues was driven by higher net product sales of Xyrem (sodium oxybate) oral solution. Total revenues include net product sales, royalties and contract revenues.

Net product sales for 2015 and the fourth quarter of 2015 were as follows:
•
Xyrem: 2015 Xyrem net sales increased by 23% to $955.2 million compared to $778.6 million during the prior year. Xyrem net sales increased by 13% to $251.8 million in the fourth quarter of 2015 compared to $222.5 million in the fourth quarter of 2014.

• Erwinaze/Erwinase (asparaginase Erwinia chrysanthemi): 2015 Erwinaze/Erwinase net sales were $203.3 million compared to $199.7 million during the prior year. Erwinaze/Erwinase net sales were $50.4 million in the fourth quarter of 2015 compared to $52.8 million in the fourth quarter of 2014. Product sales volume for the full year and fourth quarter of 2015 increased

compared to the same periods in 2014; however, net sales were negatively impacted by higher chargebacks and rebates and unfavorable foreign currency exchange rates. In the fourth quarter of 2015, the company experienced supply challenges that disrupted the ability to fully supply certain markets.

• Defitelio (defibrotide): 2015 Defitelio/defibrotide net sales were $70.7 million compared to 2014 full year pro forma Defitelio/defibrotide net sales of $73.4 million. Defitelio/defibrotide net sales from the period beginning from the closing of its acquisition of Gentium S.r.l. on January 23, 2014 to December 31, 2014 were $70.5 million. Defitelio/defibrotide net sales were $18.5 million in the fourth quarter of 2015 compared to $19.2 million in the fourth quarter of 2014. Product sales volume for the full year and fourth quarter of 2015 was consistent with the company’s expectations and higher than the same periods in 2014, but net sales were impacted by unfavorable foreign currency exchange rates.

• Prialt (ziconotide) intrathecal infusion: Prialt net sales were $26.4 million in both 2015 and 2014. Prialt net sales were $6.5 million in the fourth quarter of 2015 compared to $10.0 million in the fourth quarter of 2014. Net sales in the fourth quarter of 2014 included shipments to Eisai Co., the European distributor of Prialt.

• Psychiatry products: 2015 net sales of the company’s psychiatry products were $37.1 million compared to $40.9 million in the prior year. Net sales of the company’s psychiatry products were $8.8 million in the fourth quarter of 2015 compared to $8.4 million in the fourth quarter of 2014.

• Other: 2015 net sales of other products were $24.1 million compared to 2014 full year pro forma net sales of other products of $47.0 million. Net sales of other products in the fourth quarter of 2015 were $3.0 million compared to $11.3 million in the fourth quarter of 2014. In March 2015, the company completed the sale of certain products and the related business that the company acquired as part of the acquisition of EUSA Pharma Inc. in 2012.

Tables showing actual net product sales for the three months and year ended December 31, 2015 and 2014 and pro forma net product sales for the year ended December 31, 2014 are included in this press release.

Operating Expenses and Other
Operating expenses for 2015 were $816.6 million compared to $977.3 million for 2014. Operating expenses for 2014 included acquired in-process research and development expenses of $202.6 million. Operating expenses for the fourth quarter of 2015 were $234.3 million compared to $198.2 million for the fourth quarter of 2014. Operating expenses changed over the prior year periods primarily due to the following:

• Cost of product sales for 2015 was $102.5 million compared to $117.4 million for 2014. Cost of product sales for the fourth quarter of 2015 was $24.0 million compared to $28.8 million for the same period in 2014. Gross margin for 2015 was 92.2% compared to 89.9% for 2014. Gross margin for the fourth quarter of 2015 was 92.9% compared to 91.1% for the same period in 2014.

• Selling, general and administrative (SG&A) expenses for 2015 on a GAAP basis were $449.1 million compared to $406.1 million for 2014. SG&A expenses for the fourth quarter of 2015 on a GAAP basis were $125.6 million compared to $105.7 million for the same period in 2014. Adjusted SG&A expenses for 2015 were $355.4 million, or 27% of total revenues, compared to $321.5 million, or 27% of total revenues, for 2014. Adjusted SG&A expenses for the fourth quarter of 2015 were $87.4 million, or 26% of total revenues, compared to $83.5 million, or 25% of total revenues, for the same period in 2014. The increases were primarily due to higher headcount and other expenses resulting from the expansion of the company’s business, except that the increase in GAAP SG&A expenses for the fourth quarter of 2015 compared to the same period in 2014 was primarily due to a one-time charge for settlement of a contract claim originally

asserted against Azur Pharma Public Limited Company (Azur Pharma) prior to the 2012 merger between Azur Pharma and Jazz Pharmaceuticals, Inc.

• Research and development (R&D) expenses for 2015 on a GAAP basis were $135.3 million compared to $85.2 million for 2014. R&D expenses for the fourth quarter of 2015 on a GAAP basis were $29.5 million compared to $24.6 million for the same period in 2014. Adjusted R&D expenses for 2015 were $96.7 million, or 7% of total revenues, compared to $71.8 million, or 6% of total revenues, for 2014. Adjusted R&D expenses for the fourth quarter of 2015 were $26.0 million, or 8% of total revenues, compared to $21.2 million, or 6% of total revenues, for the same period in 2014. The increases were primarily due to higher costs for clinical studies and outside services for the development of JZP-110 and line extensions for the company’s existing products, except that the increase in GAAP R&D expenses for full year 2015 compared to the same period in 2014 was primarily due to a $25.0 million milestone payment that was triggered by the acceptance for filing by the U.S. Food and Drug Administration (FDA) of the first new drug application (NDA) for defibrotide.

• Acquired in-process research and development expenses of $202.6 million in 2014 primarily related to upfront and milestone payments of $127.0 million made in connection with the acquisition of rights to JZP-110 and an upfront payment of $75.0 million made in connection with the acquisition of rights to defibrotide in the Americas.

• Impairment charges of $31.5 million in 2015 resulted from the termination of the suspended JZP-416 study. Impairment charges of $39.4 million in 2014 related to certain products we sold in March 2015 that we acquired as part of the EUSA acquisition.
Net interest expense in 2015 was $56.9 million compared to $52.7 million for 2014. Net interest expense for the fourth quarter of 2015 was $12.2 million compared to $16.7 million for the fourth quarter of 2014. In June 2015, the company refinanced its existing term loans and revolving credit facility and obtained more favorable interest rates, which reduced interest expense in the second half of 2015.

As of December 31, 2015, cash and cash equivalents were $988.8 million, and the outstanding principal balance of the company’s long-term debt was $1.3 billion. Cash and cash equivalents increased during 2015 primarily due to cash generated by the business.
During 2015, the company repurchased 0.4 million ordinary shares for $61.6 million at an average cost of $150.24 per ordinary share.

Infinity Provides Company Update and Reports Full-Year 2015 Financial Results

On February 23, 2016 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported its full-year 2015 financial results and provided an update on its pipeline, including duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma (Press release, Infinity Pharmaceuticals, FEB 23, 2016, View Source;p=RssLanding&cat=news&id=2142341 [SID:1234509160]). Infinity expects to report topline data from DYNAMO, a Phase 2 study of duvelisib in patients with refractory indolent non-Hodgkin lymphoma (iNHL), early in the third quarter of 2016. Infinity also anticipates completing an interim analysis of DUO, a Phase 3 study of duvelisib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL), early in the second half of 2016. The company expects marketing applications, if supported by these data, to be submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the fourth quarter of 2016. Infinity also recently expanded its pipeline with the addition of IPI-549, an oral immuno-oncology development candidate targeting PI3K-gamma. A Phase 1 study of IPI-549 is ongoing.

"We made important progress across our pipeline in 2015, which included completing patient enrollment in DYNAMO and DUO, our registration-focused studies of duvelisib. These studies represent two initial paths to potential approval, and we are continuing to prepare for regulatory submissions based on data from these studies," stated Adelene Perkins, Infinity’s president and chief executive officer. "We are also advancing additional clinical studies designed to further differentiate duvelisib, with an ultimate goal of providing a potential cure for patients with hematologic malignancies through combination therapy. To implement this strategy, our partner AbbVie has under way a Phase 1b/2 clinical study of duvelisib in combination with venetoclax."

"Infinity is committed to building a pipeline of medicines that can meaningfully impact the standard of care for patients. We recently initiated a Phase 1 clinical study of IPI-549, our oral immuno-oncology development candidate. IPI-549, a selective PI3K-gamma inhibitor, has first-in-class potential and represents an important extension of our oncology portfolio to include development candidates directed at both hematologic malignancies and solid tumors," Ms. Perkins continued.

Recent achievements include the following:

Enrollment completed in registration-focused studies, DYNAMO and DUO: In September, Infinity announced it had reached target enrollment in DYNAMO, a global, Phase 2 open-label, single-arm, monotherapy study of duvelisib in approximately 120 patients with iNHL whose disease is refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study is overall response rate.

In November 2015, Infinity announced it reached target enrollment in DUO, a randomized Phase 3 monotherapy study evaluating the safety and efficacy of duvelisib compared to ofatumumab (an anti-CD20 antibody) in approximately 300 patients with relapsed or refractory CLL. The primary endpoint of this study is progression-free survival. Infinity anticipates completing an interim analysis of DUO early in the second half of 2016.

Infinity expects marketing applications, if supported by the DYNAMO and DUO data, to be submitted to the FDA and EMA in the fourth quarter of 2016.

Duvelisib-venetoclax Phase 1b/2 study under way: AbbVie has under way a Phase 1b/2 clinical study of duvelisib in combination with venetoclax, an investigational B-cell lymphoma-2 (BCL-2) selective inhibitor. This study is designed to evaluate the safety and efficacy of duvelisib in combination with venetoclax in approximately 174 patients with relapsed or refractory iNHL, aggressive NHL, small lymphocytic lymphoma or CLL.

BRAVURA study initiated: In December 2015, Infinity initiated BRAVURA, a Phase 3, double-blind, placebo-controlled study in patients with relapsed iNHL. BRAVURA is designed to evaluate the safety and efficacy of duvelisib plus rituximab and bendamustine (RB) compared to placebo plus RB in approximately 600 patients. The primary endpoint is progression-free survival.

FRESCO study initiated: In December 2015, Infinity initiated FRESCO, a Phase 2 study in patients with relapsed/refractory follicular lymphoma (FL). FRESCO is designed to evaluate the safety and efficacy of duvelisib plus rituximab versus rituximab in combination with chemotherapy in approximately 230 patients. The primary endpoint is progression-free survival.

Phase 1 clinical study of IPI-549 initiated: In January 2016, Infinity initiated a Phase 1 study of IPI-549, an oral immuno-oncology development candidate that selectively inhibits PI3K-gamma. The study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-549 as a monotherapy and in combination with an anti-PD-1 antibody, a checkpoint inhibitor, in approximately 150 patients with advanced solid tumors, including non-small cell lung cancer and melanoma. IPI-549 is the only investigational PI3K-gamma inhibitor in clinical development.
2016 Duvelisib Goals

Infinity expects to achieve the following duvelisib milestones in 2016:

Report topline DYNAMO data in 3Q16

Report topline DUO data in 2H16*

Submit a New Drug Application (NDA) for iNHL and CLL in 4Q16*

AbbVie submission of Marketing Authorization Application (MAA) for FL and CLL in 4Q16*

Report initial data from CONTEMPO, a Phase1b/2 study in treatment-naïve patients with FL, in 2H16

Advance Phase 1b/2 study of duvelisib in combination with venetoclax

*Topline DUO data report, CLL NDA filing and FL/CLL MAA filing predicated on DUO interim analysis.

Full-Year 2015 Financial Results

At December 31, 2015, Infinity had total cash, cash equivalents and available-for-sale securities of $245.2 million, compared to $333.2 million at December 31, 2014.

Revenue during 2015 was $109.1 million, which included a $75.2 million license fee associated with the $130 million milestone payment from AbbVie for the completion of patient enrollment in DYNAMO and $33.9 million in research and development (R&D) services. R&D services revenue for 2015 was composed of $12.8 million associated with the $130 million milestone payment and $21.1 million associated with the $275 million upfront payment from AbbVie received in September 2014. Revenue during 2014 was $165.0 million, which was composed of a $159.1 million license fee and $5.9 million in R&D services, both of which related to the $275 million upfront milestone from the strategic collaboration with AbbVie. Infinity will recognize the remainder of the $130 million milestone payment and $275 million upfront payment over the period in which R&D services will be provided.

R&D expense for full-year 2015 was $199.1 million, compared to $143.6 million for 2014. R&D expense for 2015 included a $52.5 million payment related to the exercise of an option to buy out the company’s royalty obligations to Takeda Pharmaceutical Company Limited for duvelisib worldwide oncology sales. R&D expense for 2014 included a $10.0 million milestone payment to Takeda for the initiation of the first duvelisib Phase 3 study and a $5.0 million payment to Takeda related to the royalty buy-out option. Excluding these payments to Takeda, the increase in R&D expense in 2015 compared to 2014 was primarily due to higher clinical development expenses for duvelisib.

General and administrative expense was $37.1 million for the full-year 2015 compared to $29.3 million for 2014. The increase in general and administrative expense in 2015 compared to 2014 was primarily due to additional personnel as well as commercial expenses in preparation for the potential 2017 duvelisib launch.

Net loss for the full-year 2015 was $128.4 million, or a basic and diluted loss per common share of $2.62, compared to $17.4 million, or a basic and diluted loss per common share of $0.36 for 2014.
2016 Financial Guidance
Infinity’s 2016 financial outlook remains as follows:

Revenue: Infinity expects revenue for 2016 to range from $225 million to $245 million, assuming the achievement of $200 million in anticipated regulatory milestones under the company’s collaboration with AbbVie: $125 million associated with the acceptance of the first NDA submission and $75 million associated with the acceptance of the first MAA submission. Infinity expects to record the $200 million in milestone revenue in the fourth quarter of 2016 and expects payment by AbbVie in the first quarter of 2017.

Net Income: Infinity expects net income for 2016 to range from $15 million to $35 million.

Cash and Investments: Infinity expects to end 2016 with a year-end cash and investments balance ranging from $45 million to $65 million. This year-end cash and investments balance excludes the $200 million in anticipated milestones, which Infinity expects to be paid by AbbVie in the first quarter of 2017.

Foundation Medicine Announces 2015 Fourth Quarter and Year-End Results, Recent Highlights and 2016 Outlook

On february 23, 2016 Foundation Medicine (NASDAQ: FMI) reported financial and operational results for the fourth quarter and year ended December 31, 2015 (Press release, Foundation Medicine, FEB 23, 2016, View Source [SID:1234509156]). Highlights for the quarter and year included:

Fourth quarter revenue of $26.1 million, 39% year-over-year growth;

8,286 clinical tests reported in the fourth quarter, 15% year-over-year growth;

Full year 2015 revenue of $93.2 million, 53% year-over-year growth;

32,998 clinical tests reported in 2015, 36% year-over-year growth;

Improving patient access to comprehensive genomic profiling by signing a national agreement with United Healthcare for FoundationOne in metastatic non-small cell lung cancer. Additionally, Palmetto GBA, a Medicare Administrative Contractor (MAC), announced a final local coverage determination for comprehensive genomic profiling in a subset of patients with non-small cell lung cancer;

Broadening molecular information solutions with the addition of PatientMatchTM, GeneKitTM and SmartTrialsTM; and,

Expanding FoundationCORE molecular information knowledgebase to more than 68,000 cases.

The company reported total revenue of $26.1 million in the fourth quarter of 2015, compared to $18.7 million in the fourth quarter of 2014. Revenue from clinical testing in the fourth quarter of 2015 was $12.0 million, compared to $10.3 million in the fourth quarter of 2014. Total revenue for the year ended December 31, 2015 was $93.2 million, compared to $61.1 million in 2014.

The company reported 8,286 clinical tests, which includes 7,382 FoundationOne tests and 904 FoundationOne Heme tests, in the fourth quarter of 2015, a 15% increase from the total reported clinical tests in fourth quarter of 2014. An additional 3,104 tests were reported to pharmaceutical partners in the fourth quarter of 2015. The company reported 32,998 clinical tests, which includes 29,076 FoundationOne tests and 3,922 FoundationOne Heme tests, for the full year 2015, a 36% increase compared to the total reported clinical tests in 2014.

Revenue from pharmaceutical partners was $14.1 million in the fourth quarter, representing a 68% increase from the same period in 2014 and a 20% increase from the third quarter of 2015. For the full year, revenue from pharmaceutical partners was $44.0 million, an 80% increase from the $24.4 million in 2014. These increases in revenue from pharmaceutical partners highlight the company’s leading and broadening role within targeted oncology drug development.

"In 2015, Foundation Medicine made continued progress across the oncology ecosystem by delivering valuable insights from our molecular information platform to clinicians, payers and biopharmaceutical companies," stated Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. "As we look ahead to 2016, we are poised for continued growth and expect to drive value both near and long term through product innovation, commercial execution and further integration of our molecular information platform to enable precision medicine."

The company’s cancer knowledgebase, FoundationCORE, grew to more than 68,000 clinical cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers.

Total operating expenses for the fourth quarter of 2015 were approximately $34.0 million compared with $25.1 million for the fourth quarter of 2014. For the full year, operating expenses were $143.5 million, compared to $86.9 million in 2014. Net loss was $19.0 million in the fourth quarter of 2015, or a $0.55 loss per share, and net loss for the full year was $89.6 million, or a $2.73 loss per share. At December 31, 2015, the company held approximately $232.3 million in cash, cash equivalents and marketable securities.

Recent Highlights:

Initiated a prospective clinical study with Horizon Healthcare Services and Clinical Outcomes Tracking Analysis (COTA) to measure changes in survival benefit and total cost savings achieved among patients with previously untreated metastatic non-small cell lung cancer who undergo comprehensive genomic profiling with FoundationOne.

Announced a collaboration agreement with Mirati Therapeutics to develop a companion diagnostic test using the FoundationOne platform for Mirati’s kinase inhibitor, glesatinib.

Launched a circulating tumor DNA (ctDNA) assay to biopharmaceutical partners. The Company is on track to launch its ctDNA assay, FoundationACT, to its clinical customers during the first quarter of 2016.

Throughout the fourth quarter, the Company presented clinical data at seven medical conferences, including four podium presentations and 20 posters, to further support its commercial and reimbursement strategies.

2016 Outlook

The company expects 2016 revenue will be in the range of $110 to $120 million.

The company expects to deliver between 37,000 and 40,000 FoundationOne and FoundationOne Heme clinical tests in 2016.

The company expects operating expenses will be in the range of $175 and $185 million.

The company plans to expand its offering of molecular information products with the commercial launch of its ctDNA assay in the first quarter 2016.

The company expects to expand upon reimbursement progress made in 2015 and drive additional coverage decisions.