Stemline Therapeutics Reports First Quarter 2016 Financial Results

On May 09, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported financial results for the quarter ended March 31, 2016 (Press release, Stemline Therapeutics, MAY 9, 2016, View Source [SID:1234512127]).

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Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "During the first quarter, we made substantial progress across our multiple clinical programs. In particular, we continued to advance our ongoing potentially pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN). We look forward to sharing updated data from this trial at our principal investigator’s oral presentation at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)."

Dr. Bergstein, continued, "Our team has executed extremely well, reaching our first quarter enrollment goals in our ongoing SL-401 trials in BPDCN and additional indications, as well as treating the first patients with SL-801 in our Phase 1 trial of advanced solid tumors. We also continue to meet accrual expectations in our SL-701 Phase 2 trial in second-line glioblastoma. With this level of performance, coupled with our strong cash position, we believe we have the resources to achieve significant clinical and regulatory milestones this year and beyond."

First Quarter 2016 Financial Results Review
Stemline ended the first quarter of 2016 with $87.8 million in cash, cash equivalents and investments, as compared to $97.5 million as of December 31, 2015, which reflects a cash burn of $9.7 million for the quarter. The company ended the first quarter of 2016 with 19.0 million shares outstanding.

For the first quarter of 2016, Stemline had a net loss of $9.0 million, or $0.51 per share, compared with a net loss of $7.7 million, or $0.46 per share, for the same period in 2015.

Research and development expenses were $6.5 million for the first quarter of 2016, which reflects an increase of $0.5 million, or 8%, compared with $6.0 million for the first quarter of 2015. The higher expenses during the first quarter were primarily attributable to the ramp up in clinical trial activities.

General and administrative expenses were $2.9 million for the first quarter of 2016, which reflects an increase of $1.1 million, or 58%, compared with $1.8 million for the first quarter of 2015. The increase in expense year over year was primarily attributable to higher non-cash stock based compensation and payroll costs relating to employees.

10-Q – Quarterly report [Sections 13 or 15(d)]

Scynexis has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Scynexis, 2017, MAY 9, 2016, View Source [SID1234521705]).

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bluebird bio Presents Oncology and Gene Therapy Data at the ASGCT 19th Annual Meeting

On May 9, 2016 bluebird bio, Inc. (Nasdaq:BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies for cancer, reported the presentation of pre-clinical data from its immuno-oncology and hematopoietic stem cell (HSC) gene therapy programs at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 19th Annual Meeting, taking place May 4-7, 2016 in Washington, D.C (Press release, bluebird bio, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166363 [SID:1234512103]).

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Additionally, two oral presentations given by bluebird’s academic collaborators highlighted previously presented data from bluebird bio’s ongoing gene therapy clinical trials. David Williams, M.D., president of Dana-Farber/Boston Children’s Cancer and Blood Disorders Center presented interim data from the Starbeam Study of Lenti-D in cerebral adrenoleukodystrophy, and Marina Cavazzana, M.D., Ph.D., of Hospital Necker, University Paris Descartes, presented interim data from the HGB-205 study of LentiGlobin in severe sickle cell disease and transfusion-dependent β-thalassemia.

"The preclinical data presented at ASGCT (Free ASGCT Whitepaper) are testament to bluebird’s commitment to developing next-generation immuno-oncology and gene therapies. We are particularly excited about our oncology presentations, which highlighted our progress toward the generation of T cells with sustained anti-tumor activity as well as research on small-molecule regulated multi-chain chimeric antigen receptors known as Darics," said Philip Gregory, D.Phil., chief scientific officer, bluebird bio. "For our hematopoietic stem cell programs, scalable manufacturing and transduction efficiency remain areas of focus and importance for bluebird. Multiple presentations at ASGCT (Free ASGCT Whitepaper) discussed encouraging examples of our efforts on these fronts – with more to come as we continue to innovate in this critical direction."

Oncology Presentations:

Oral Abstract #277: Small Molecule-regulated Antigen Recognition System for Inducible T Cell Targeting of Cancer Cells

Overview and results presented by Wai-Hang Leung, Ph.D., bluebird bio.

bluebird bio scientists presented data on a small-molecule regulated CAR (Daric) for applications where it may be useful to turn antigen-driven T cell activity on or off, such as minimizing off-tumor activity. In addition to potentially providing an enhanced safety profile for CAR T cells, this technology could be applied in other indications such as autoimmune disease.
Daric engineered CAR T cells possess minimal activity in the absence of dimerizing agents (rapamycin / AP21967), and antigen-specific cytotoxicity and cytokine production are significantly upregulated with the addition of rapamycin / AP21967.
Oral Abstract #747: Towards the Clinical Application of BCMA CAR T cells: The Importance of Reduced Tonic Signaling and Methods to Enhance Memory T Cells

Results presented by Kevin Friedman, Ph.D., bluebird bio.

bluebird bio has developed a potent CAR targeting BCMA (bb2121) to treat multiple myeloma and some lymphomas. The initial clinical application of this technology to treat patients with multiple myeloma began in February.
bluebird bio scientists demonstrated that a property called tonic signaling can reduce CAR T cell durability and tumor control, but careful CAR engineering can avoid this problem. Furthermore, simple manufacturing changes involving inhibition of the PI3K pathway can significantly increase the potency and fitness of CAR T cells.
Abstract #323: Efficient Generation of CART Cells by Homology Directed Transgene Integration into the TCR-Alpha Locus

Results presented by Baeckseung Lee, Ph.D., bluebird bio.

Homology directed transgene integration combines nuclease-mediated gene disruption with site-specific integration of novel genetic material. Using bluebird bio’s proprietary gene editing technology, megaTALs, bluebird scientists demonstrated that this can be efficiently accomplished in primary human T cells by introducing a CD19 CAR into the TCR alpha gene (TRAC).
Nuclease generated CAR T cells had similar cytotoxicity and cytokine production compared to those made by lentiviral vector transduction. These data demonstrate the potential for megaTAL-mediated targeted gene addition as a robust method for the genetic editing of CAR T cells.
HSC Gene Therapy Presentations

Abstract #221: Staurosporine Increases Lentiviral Transduction of Human CD34+ Cells

Results presented by Melissa Bonner, Ph.D., bluebird bio.

bluebird has been evaluating numerous compounds for the potential to increase vector copy number (VCN) and enhance cell transduction in lentiviral vector (LVV)-based gene therapy.
Limited staurosporine treatment prior to LVV transduction can increase the proportion of modified cells, including long-term repopulating cells, in a gene modified cell product.
This work received an "Outstanding Poster Award" from the ASGCT (Free ASGCT Whitepaper).
Abstract #229: PGE2 Increases Lentiviral Vector Transduction Efficiency of Human HSC

Results presented by Garrett C. Heffner, Ph.D., bluebird bio.

As part of its work to evaluate small molecules that may increase VCN and enhance cell transduction, bluebird identified PGE2 as a VCN enhancer in CD34+ cells.
PGE2 improves VCN approximately 2-fold from multiple healthy normal CD34+ cell donors as well as donors with primary hemoglobinopathies. These increases in VCN also result in an increased percentage of cells with integrated lentiviral vector leading to improved globin expression in in vitro preclinical models.
Abstract #458: Development of a stable producer cell line for scalable lentiviral vector production for gene therapy of hemoglobinopathies

Results presented by Sarah Slauson, bluebird bio

Current manufacturing of clinical grade lentiviral vectors commonly relies on transient infection of adherent 293T cells. An inducible producer cell line grown in suspension culture represents a potentially more scalable manufacturing process for vector production, eliminating the need for costly plasmid and transfection reagents.
bluebird bio scientists have developed 293F-based stable packaging and producer cell lines for inducible production of LentiGlobin BB305, and reported the successful production of LentiGlobin BB305 at research scale in suspension culture.
Abstract #473: Qualification of a p24 ELISA Assay for Quantitation of Total Lentiviral Vector Concentration

Results presented by Elisabeth Boucher, bluebird bio.

The availability of reliable analytical tools to characterize purified LVV product and in-process samples is critical to successful LVV process development. In support of late-stage process characterization, it is essential to qualify the assay and demonstrate its suitability to test in-process samples in different matrices.
Scientists at bluebird bio reported on the qualification of a p24 ELISA assay for LVV quantitation, showing precision, repeatability, specificity and accuracy within an established range, adequate to support late-stage process characterization activities.
Abstract #709: Characterization of Nanoparticles in Lentiviral Vector Preparations

Results presented by Erik Hansen, bluebird bio.

Progress to late-stage clinical development of lentivirus based gene therapies and CAR T therapies will require enhanced characterization of the purified lentivirus product. LVV preparations are complex and utilize host cells that produce not only the viral particles of interest, but also a variety of closely related impurities that can include microvesicles. These cell-derived impurities can overlap key biophysical and biochemical attributes of the LVV, making them challenging to analyze.
bluebird bio scientists reported on the use of various analytical tools to further characterize LVV preparations in terms of particle size distribution and counts, as well as methods for determining the total particle to infectious particle ratio.

Teva Reports First Quarter 2016 Results

On May 9, 2016 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) reported results for the quarter ended March 31, 2016 (Press release, Teva, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166269 [SID:1234512128]).
Q1 2016
Revenues $4.81 billion
Cash flow from Operations $1.38 billion
Non-GAAP EPS $1.20
GAAP EPS $0.62

Non-GAAP EPS adjusted to exclude December 2015 equity offerings was $1.36, in line with results in the first quarter of 2015.
Exchange rate fluctuations reduced revenues by $107 million and non-GAAP operating profit by $30 million.
Second quarter 2016 revenues are expected to be $4.7-$4.9 billion; non-GAAP EPS expected to be $1.16-$1.20; non-GAAP EPS, adjusted to exclude the impact of the December 2015 equity offerings, is expected to be $1.32-$1.36.
Our guidance for the second quarter of 2016 does not include any Actavis Generics revenues or profit. We expect to close the Actavis Generics acquisition in June 2016.
"We start 2016 with solid performance across the business, strong financial results and the achievement of several key milestones. Generics remains a core contributor to our performance despite no major launches in the U.S. this quarter as we had in the first quarter 2015 with continuous operational and financial improvement across the business. We finalized our acquisition of Rimsa and completed the business venture in Japan with Takeda. We continue to make important progress in our specialty business where we see great promise," stated Erez Vigodman, President & CEO of Teva. "Looking forward, we have several upcoming approvals and key clinical milestones in our pipeline and of course the much anticipated close of Actavis Generics. We are excited to be in the final stages of completing the acquisition of Actavis Generics, which will enable us to further realize the enormous potential in the growing global generics universe and deliver the benefits of this transaction to our stockholders, customers, patients and healthcare systems around the world."
First Quarter 2016 Results
Revenues in the first quarter of 2016 amounted to $4.8 billion, down 3% compared to the first quarter of 2015. Excluding the impact of foreign exchange fluctuations, revenues were down 1%.
Exchange rate differences (net of profits from certain hedging transactions) between the first quarter of 2016 and the first quarter of 2015 decreased revenues by $107 million, and both non-GAAP and GAAP operating income by $30 million.
Non-GAAP gross profit was $3.0 billion in the first quarter of 2016, down 2% from the first quarter of 2015. Non-GAAP gross profit margin was 62.7% in the first quarter of 2016, compared to 61.5% in the first quarter of 2015. GAAP gross profit was $2.8 billion in the first quarter of 2016, down 2% compared to the first quarter of 2015. GAAP gross profit margin was 58.0% in the quarter, compared to 56.9% in the first quarter of 2015.
Research and Development (R&D) expenses (excluding equity compensation expenses and purchase of in-process R&D) in the first quarter of 2016 amounted to $375 million, compared to $328 million in the first quarter of 2015. R&D expenses were 7.8% of revenues in the quarter, compared to 6.6% in the first quarter of 2015. R&D expenses related to our generic medicines segment increased 23% to $136 million, compared to $111 million in the first quarter of 2015. The increase is mainly due to increased development of complex generic products such as sterile and respiratory medicines. R&D expenses related to our specialty medicines segment increased 7% to $229 million, compared to $215 million in the first quarter of 2015, mainly due to increased development costs related to assets acquired through the Labrys and Auspex transactions.
Selling and Marketing (S&M) expenses (excluding amortization of purchased intangible assets and equity compensation expenses) amounted to $821 million, or 17.1% of revenues, in the first quarter of 2016, compared to $908 million, or 18.2% of revenues, in the first quarter of 2015. S&M expenses related to our generic medicines segment decreased 25% to $279 million, compared to $374 million in the first quarter of 2015. The decrease was mainly due to reduced royalties related to our sales of budesonide (Pulmicort) in the United States. S&M expenses related to our specialty medicines segment decreased 6% to $457 million, compared to $486 million in the first quarter of 2015.
General and Administrative (G&A) expenses (excluding equity compensation expenses) amounted to $294 million in the first quarter of 2016, or 6.1% of revenues, compared to $293 million and 5.9% in the first quarter of 2015.
Quarterly non-GAAP operating income was $1.5 billion, similar to the first quarter of 2015. Quarterly GAAP operating income was $1.2 billion in the first quarter of 2016, an increase of 56% compared to $0.7 billion in the first quarter of 2015.
We calculate EBITDA as non-GAAP operating income (which excludes amortization and certain other items) plus depreciation expenses for the period. In the first quarter of 2016, depreciation amounted to $108 million, compared to $113 million in the first quarter of 2015. EBITDA for the first quarter of 2016 amounted to $1.6 billion, down 1% compared to the first quarter of 2015.
Non-GAAP financial expenses amounted to $52 million in the first quarter of 2016, compared to $49 million in the first quarter of 2015. GAAP financial expenses for the first quarter of 2016 amounted to $298 million, compared to $192 million in the first quarter of 2015. The higher expenses, on a GAAP basis, were mainly the result of a $246 million impairment of net monetary assets following the devaluation in Venezuela.
The provision for non-GAAP income taxes for the first quarter of 2016 amounted to $302 million on pre-tax non-GAAP income of $1.5 billion, for a quarterly tax rate of 21%. The provision for non-GAAP income taxes in the first quarter of 2015 was $312 million on pre-tax non-GAAP income of $1.5 billion, for a quarterly tax rate of 21%. GAAP income tax expenses for the first quarter of 2016 amounted to $228 million or 26%, on pre-tax income of $867 million. In the first quarter of 2015, the provision for income taxes amounted to $104 million or 19%, on pre-tax income of $557 million. While the tax rate may fluctuate quarterly, we expect our annual tax rate for 2016 to be similar to that for 2015.
Non-GAAP net income attributable to ordinary shareholders and non-GAAP diluted EPS were $1.2 billion and $1.20, respectively, in the first quarter of 2016, compared to $1.2 billion and $1.36 in the first quarter of 2015. Non-GAAP EPS adjusted to exclude the December 2015 equity offerings was $1.36. GAAP net income attributable to ordinary shareholders and GAAP diluted EPS were $570 million and $0.62, respectively, in the first quarter of 2016, compared to $446 million and $0.52, respectively, in the first quarter of 2015.
Non-GAAP information: Net non-GAAP adjustments in the first quarter of 2016 amounted to $536 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:
Financial expenses of $246 million related to the impairment of our net monetary assets in Venezuela following a change in exchange rates;
Amortization of purchased intangible assets totaling $189 million, of which $178 million is included in cost of goods sold and the remaining $11 million in selling and marketing expenses;
Acquisition and related expenses of $101 million;
Equity compensation of $24 million;
Restructuring expenses of $19 million;
Impairment of long-lived assets of $13 million;
Other non-GAAP items of $43 million;
Income from legal settlements and loss contingencies of $25 million; and
Corresponding tax benefit of $74 million.
Teva believes that excluding such items facilitates investors’ understanding of its business and financial results. See the attached tables for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures.
Cash flow from operations generated during the first quarter of 2016 amounted to $1.4 billion, as in the first quarter of 2015. Free cash flow, excluding net capital expenditures, amounted to $1.2 billion, similar to the first quarter of 2015.
Cash and investments at March 31, 2016 decreased to $7.2 billion, compared to $8.4 billion at December 31, 2015, mainly due to the funding of the Rimsa acquisition.
For the first quarter of 2016, the weighted average outstanding shares for the fully diluted earnings per share calculation were 979 million on a non-GAAP basis and 920 million on a GAAP basis. The average weighted diluted shares outstanding used for the fully diluted share calculation for the first quarter of 2015 were 859 million shares, on both a non-GAAP and GAAP basis. The increase in the number of shares resulted from our December 2015 equity offerings, with the number of shares on a non-GAAP basis including the potential dilution resulting from our recently issued mandatory convertible preferred shares, which had a dilutive effect on our non-GAAP earnings per share.
Excluding the impact of the December 2015 equity offerings to finance the Actavis Generics acquisition, the weighted average outstanding shares for the fully diluted earnings per share calculation on a non-GAAP basis for the first quarter of 2016 was 861 million shares.
As of March 31, 2016, the fully diluted share count for calculating Teva’s market capitalization was approximately 1,003 million shares.
Total shareholders’ equity was $30.6 billion at March 31, 2016, compared to $29.9 billion at December 31, 2015.
Segment Results for the First Quarter 2016
Generic Medicines Segment
Three Months Ended March 31,
2016 2015
U.S.$ in millions / % of Segment Revenues

Revenues $ 2,170
100.0%
$ 2,621
100.0%
Gross profit 999 46.0% 1,284 49.0%
R&D expenses 136 6.3% 111 4.2%
S&M expenses 279 12.8% 374 14.3%
Segment profit* $ 584 26.9% $ 799 30.5%
____________________
* Segment profit consists of gross profit for the segment, less R&D and S&M expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items.

Generic Medicines Revenues
Generic medicines revenues in the first quarter of 2016 amounted to $2.2 billion, a decrease of 17% compared to the first quarter of 2015. In local currency terms, revenues decreased 15%.
Generic revenues consisted of:
U.S. revenues of $976 million, a decrease of 32% or of $463 million, compared to the first quarter of 2015. The decrease resulted mainly from a decline in sales of $427 million due to the loss of exclusivity on esomeprazole (Nexium) and budesonide (Pulmicort).
European revenues of $671 million, a decrease of 1%, but up 1% in local currency terms, compared to the first quarter of 2015. This resulted mainly from our strategy of pursuing profitable and sustainable business in the region, along with higher API sales to third parties.
ROW revenues of $523 million, an increase of 4%, or 13% in local currency terms, compared to the first quarter of 2015. The increase in local currency terms was mainly due to higher revenues in Venezuela and Canada, which were partially offset by lower revenues in Japan and Russia.
API sales to third parties of $197 million (which is included in the market revenues above), an increase of 25% compared to the first quarter of 2015, with higher revenues in both Europe and the United States.
Generic medicines revenues comprised 45% of our total revenues in the quarter, compared to 52% in the first quarter of 2015.
Generic Medicines Gross Profit
Gross profit from our generic medicines segment in the first quarter of 2016 amounted to $1.0 billion, a decrease of 22% compared to the first quarter of 2015. The lower gross profit was mainly a result of the lower sales of esomeprazole (Nexium) and budesonide (Pulmicort) in the United States, which are both high gross profit products. This decrease was partially offset by higher gross profit of our ROW markets and API business. Gross profit margin for our generic medicines segment in the first quarter of 2016 decreased to 46.0%, from 49.0% in the first quarter of 2015.
Generic Medicines Profit
Our generic medicines segment generated profit of $584 million in the first quarter of 2016, a decrease of 27% compared to the first quarter of 2015. Generic medicines profitability as a percentage of generic medicines revenues was 26.9% in the first quarter of 2016, down from 30.5% in the first quarter of 2015. The decrease was primarily due to the lower gross profit of the segment, which was partially offset by lower S&M expenses.
Specialty Medicines Segment
Three Months Ended March 31,
2016 2015
U.S.$ in millions / % of Segment Revenues

Revenues $ 2,152
100.0%
$ 1,956
100.0%
Gross profit 1,871 86.9% 1,678 85.8%
R&D expenses 229 10.6% 215 11.0%
S&M expenses 457 21.2% 486 24.9%
Segment profit* $ 1,185 55.1% $ 977 49.9%
____________________
* Segment profit is comprised of gross profit for the segment, less R&D and S&M expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items.

Specialty Medicines Revenues
Specialty medicines revenues in the first quarter of 2016 amounted to $2.2 billion, an increase of 10% compared to the first quarter of 2015. In local currency terms, revenues increased 11%. U.S. specialty medicines revenues amounted to $1.7 billion, up 13% compared to the first quarter of 2015. European specialty medicines revenues amounted to $394 million, a decrease of 3%, but flat in local currency terms, compared to the first quarter of 2015. ROW specialty revenues amounted to $81 million, up 13%, or 27% in local currency terms, compared to the first quarter of 2015.
Specialty medicines revenues comprised 45% of our total revenues in the quarter, compared to 40% in the first quarter of 2015.
The increase in specialty medicines revenues compared to the first quarter of 2015 was primarily due to higher sales of our CNS and respiratory products.
The following table presents revenues by therapeutic area and key products for our specialty medicines segment for the three months ended March 31, 2016 and 2015:

Three Months Ended
March 31,
Percentage
Change
2016 2015 2016 – 2015
U.S. $ in millions
CNS $ 1,323 $ 1,220 8%
Copaxone 1,006 924 9%
Azilect 113 107 6%
Nuvigil 103 85 21%
Respiratory 366 265 38%
ProAir 173 124 40%
QVAR 134 98 37%
Oncology 268 264 2%
Treanda and Bendeka 155 157 (1%)
Women’s Health 110 129 (15%)
Other Specialty 85 78 9%
Total Specialty Medicines $ 2,152 $ 1,956 10%

Global revenues of Copaxone (20 mg/mL and 40 mg/mL), the leading multiple sclerosis therapy in the U.S. and globally, amounted to $1.0 billion, an increase of 9% compared to the first quarter of 2015.
Copaxone revenues in the United States amounted to $821 million, an increase of 12% compared to the first quarter of 2015. The increase was mainly due to higher net pricing, including a price increase of 7.9% in January 2016. At the end of the first quarter of 2016, according to March 2016 IMS data, our U.S. market shares for the Copaxone products in terms of new and total prescriptions were 28.1% and 29.8%, respectively. Copaxone 40 mg/mL accounted for over 81% of total Copaxone prescriptions in the U.S.
Copaxone revenues outside the United States amounted to $185 million, a decrease of 4%, but an increase of 2% in local currency terms, compared to the first quarter of 2015.
Our global Azilect revenues amounted to $113 million, an increase of 6% compared to the first quarter of 2015. In local currency terms, revenues increased 7%. Global in-market sales decreased 13%.
Revenues of our respiratory products amounted to $366 million, up 38% compared to the first quarter of 2015. ProAir revenues in the quarter increased 40% to $173 million, compared to the first quarter of 2015, due to volume growth and positive price effects. QVAR global revenues increased 37% to $134 million in the first quarter of 2016, compared to the first quarter of 2015, mainly due to positive price effects.
Revenues of our oncology products amounted to $268 million in the first quarter of 2016, up 2% from the first quarter of 2015. Revenues of Treanda and Bendeka amounted to $155 million, down 1% compared to the first quarter of 2015.
Specialty Medicines Gross Profit
Gross profit from our specialty medicines segment amounted to $1.9 billion, an increase of $193 million compared to the first quarter of 2015. Gross profit margin for our specialty medicines segment in the first quarter of 2016 was 86.9%, compared to 85.8% in the first quarter of 2015.
Specialty Medicines Profit
Our specialty medicines segment profit amounted to $1.2 billion in the first quarter of 2016, up 21% compared to the first quarter of 2015, mainly due to higher gross profit and lower S&M expenses.
Specialty medicines profit as a percentage of segment revenues was 55.1% in the first quarter of 2016, up from 49.9% in the first quarter of 2015.
The following tables present details of our multiple sclerosis franchise and of our other specialty medicines for the three months ended March 31, 2016 and 2015:
Multiple Sclerosis
Three months ended March 31,
2016 2015
U.S.$ in millions / % of MS Revenues

Revenues $ 1,006
100.0%
$ 924
100.0%
Gross profit 919 91.4% 819 88.6%
R&D expenses 25 2.5% 27 2.9%
S&M expenses 89 8.9% 135 14.6%
MS profit $ 805 80.0% $ 657 71.1%


Other Specialty
Three months ended March 31,
2016 2015
U.S.$ in millions / % of Other Specialty Revenues

Revenues $ 1,146
100.0%
$ 1,032
100.0%
Gross profit 952 83.1% 859 83.2%
R&D expenses 204 17.8% 188 18.2%
S&M expenses 368 32.1% 351 34.0%
Other Specialty profit $ 380 33.2% $ 320 31.0%

Other Activities
Our OTC revenues related to PGT amounted to $288 million, an increase of 35% compared to $213 million in the first quarter of 2015. In local currency terms, revenues increased 47%, mainly due to inflation and higher volumes in Venezuela. PGT’s in-market sales amounted to $411 million in the first quarter of 2016, an increase of $37 million compared to the first quarter of 2015.
Other revenues amounted to $200 million in the first quarter of 2016, mostly from the distribution of third-party products in Israel and Hungary, compared to revenues of $192 million in the first quarter of 2015.
Financial Outlook
Pending the closing of the Actavis Generics acquisition, we are providing revenue and non-GAAP EPS guidance for the second quarter 2016. This includes the results of the Rimsa acquisition and the Teva-Takeda business venture, but not of the Actavis Generics acquisition. Additional guidance will be provided after closing the Actavis Generics acquisition.
We continue to work toward satisfying all conditions for the closing and, based on our estimate of the timing to obtain clearance from the U.S. Federal Trade Commission, we currently expect to close in June 2016.
We expect revenues for the second quarter of 2016 to be $4.7-$4.9 billion.
Non-GAAP EPS for the second quarter of 2016 is expected to be $1.16-$1.20. Excluding the impact of the December 2015 equity offerings, non-GAAP EPS is expected to be $1.32-$1.36.
Cash flow from operating activities for the second quarter of 2016 is expected to be $1.2-$1.3 billion.
These estimates reflect management`s current expectations for Teva’s performance in 2016. Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors. In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments and related tax effects.
The non-GAAP data presented by Teva are the results used by Teva’s management and board of directors to evaluate the operational performance of the company, to compare against the company’s work plans and budgets, and ultimately to evaluate the performance of management. Teva provides such non-GAAP data to investors as supplemental data and not in substitution or replacement for GAAP results, because management believes such data provides useful information to investors.
Dividend
On May 5, 2016, the Board of Directors declared a cash dividend of $0.34 per ordinary share for the first quarter of 2016. For holders of our ordinary shares that are traded on the Tel Aviv Stock Exchange, the dividend will be converted into new Israeli shekels based on the official exchange rate as of May 9, 2016.
The record date will be May 24, 2016, and the payment date will be June 7, 2016. Tax will be withheld at a rate of 15%.
On March 15, 2016, we paid a dividend of $71 million (including withholding taxes) to the holders of record of our mandatory convertible preferred shares as of March 1, 2016.

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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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10-Q – Quarterly report [Sections 13 or 15(d)]

Juno has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Juno, MAY 9, 2016, View Source [SID1234512165]).

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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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