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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On May 09, 2016 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported its financial results for the first quarter ended March 31, 2016 (Press release, Curis, MAY 9, 2016, View Source [SID:1234512108]).

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"We are pleased with the initiation of the Phase 2 study with CUDC-907 earlier this year in patients with relapsed/refractory Diffuse Large B Cell Lymphoma (DLBCL) that harbor MYC alterations," said Ali Fattaey, Ph.D., Curis’s President and CEO. "At the recent AACR (Free AACR Whitepaper) annual conference, we presented preclinical data, which provide further evidence for CUDC-907’s effect on downregulating MYC and its anti-tumor activity in multiple lymphoma and solid tumor models with alterations in MYC oncogene."

Dr. Fattaey continued, "All IND enabling studies with CA-170 have been completed, and we remain on track to initiate a Phase 1 study in cancer patients in the first half of 2016 with CA-170 as our first oral immuno-oncology drug candidate. Additionally, preclinical development of small molecule leads that target PD-L1 and TIM3 in our second immuno-oncology program is progressing well and these candidates further underscore the potential of this discovery platform to generate multiple oral small molecule drug candidates that can modulate independent immune checkpoint targets."

First Quarter 2016 Financial Results

Curis reported a net loss of $9.4 million, or ($0.07) per share, on both a basic and diluted basis for the first quarter of 2016, as compared to a net loss of $31.8 million, or ($0.30) per share, on both a basic and diluted basis for the same period in 2015. The net loss for the prior year period includes a non-cash in-process research and development charge of $24.3 million related to Curis’s license agreement with Aurigene.

Revenues were $1.7 million for each of the first quarters of 2016 and 2015. Revenues for both periods are comprised primarily of royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses were $10.5 million for the first quarter of 2016, as compared to $32.7 million for the same period in 2015, and comprised the following:

Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $89,000 for the first quarter of 2016, up from $84,000 during the first quarter of 2015.

In-Process Research and Development Expense. No in-process research and development expenses were recorded for the three months ended March 31, 2016 as compared to $24.3 million recorded during the first quarter of 2015 associated with the issuance of 17,120,131 shares of Curis common stock to Aurigene as partial consideration for the rights granted under the terms of our January 2015 collaboration agreement.

Research and Development Expenses. Research and development expenses were $6.8 million for the first quarter of 2016, as compared to $4.7 million for the same period in 2015. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and programs under the Aurigene collaboration over the prior year period. Employee-related expenses increased over the prior year period primarily due to additional headcount to support the multiple programs.

General and Administrative Expenses. General and administrative expenses remained unchanged at $3.5 million for first quarter of 2016 and $3.5 million for the same period in 2015.

Other expense was $635,000 for the first quarter of 2016, as compared to $827,000 for the same period in 2015. Other expense primarily consisted of $740,000 and $867,000 in interest expense for the quarters ended March 31, 2016 and 2015, respectively, related to the loan made by BioPharma-II (an investment fund managed by Pharmakon Advisors) to Curis Royalty (a wholly-owned subsidiary of Curis).

As of March 31, 2016, Curis’s cash, cash equivalents, marketable securities and investments totaled $73.1 million and there were approximately 129.0 million shares of common stock outstanding.

Recent Operational Highlights

Precision oncology (HDAC / PI3K inhibitor program):

In April 2016, preclinical data were presented for CUDC-907 at the Annual Meeting of American Association of Cancer Research (AACR) (Free AACR Whitepaper) in New Orleans. The presentation included data for CUDC-907’s anti-tumor activity in multiple in vitro and in vivo MYC-altered disease models, including lymphomas and solid tumors, and the molecule’s effect on downregulating MYC levels.

In January 2016, Curis initiated an open label Phase 2 study to evaluate the efficacy and safety of CUDC-907 with and without rituximab in patients with relapsed/refractory MYC-altered DLBCL.
Immuno-oncology (PD-L1 / VISTA antagonist program):

In April 2016, preclinical data were presented for CA-170, a small molecule, orally available antagonist of PD-L1 and VISTA at the Annual AACR (Free AACR Whitepaper) meeting in New Orleans. The data presented included the pharmacologic and safety profile of CA-170 to support its progression into human clinical trials.
Immuno-oncology (PD-L1 / TIM-3 antagonist program):

In April 2016, preclinical data were presented from the orally available, small molecule PD-L1/TIM-3 immune checkpoint antagonist program. Results from in vitro studies with AUPM-327, a representative molecule from the PD-L1/TIM-3 program showed that AUPM-327 can selectively rescue T cell functions that are inhibited by PD-L1 or TIM-3 checkpoint proteins, but does not modulate the effects of other regulators such as VISTA, CTLA4, LAG-3, or CD-28, demonstrating its selectivity. Additionally, daily oral administration of the PD-L1/TIM-3 antagonist resulted in anti-tumor activity in multiple syngeneic tumor models including melanoma and colon cancer.
Precision oncology (IRAK4 inhibitor program):

In April 2016, preclinical data were presented for CA-4948, the oral IRAK4 inhibitor at the Annual AACR (Free AACR Whitepaper) meeting in New Orleans. The presentations outlined CA-4948’s detailed pharmacologic and biologic profile as well as data on its metabolism, pharmacokinetics properties and in vitro toxicity profile. CA-4948 demonstrated potent anti-tumor activity in two in vivo models of MYD88 mutant- DLBCL disease and anti-inflammatory effects in a rodent model of inflammation suggesting the potential use of an IRAK4 inhibitor in both cancer and inflammatory diseases.
Erivedge:

Roche initiated patient enrollment in a Phase 1 clinical study to evaluate the safety and efficacy of Erivedge in combination with ruxolitinib for the treatment of patients with intermediate- or high-risk myelofibrosis.
Roche initiated patient enrollment in a study of Erivedge in combination with pirfenidone in patients with idiopathic pulmonary fibrosis (IPF). The study is designed as a single arm, multicenter Phase 1b study to evaluate the safety and tolerability of Erivedge in combination with pirfenidone in participants with IPF currently being treated with pirfenidone.
Upcoming Activities

Curis expects that it will make presentations at the following scientific and investor conferences through June 2016:

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting on June 3-7 in Chicago
Jefferies Healthcare Conference on June 7-10 in New York City
21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) on June 9-12 in Copenhagen, Denmark
Our partner, Roche/Genentech expect to present data on Erivedge at ASCO (Free ASCO Whitepaper) 2016 Annual Meeting in Chicago from June 3-7.

On May 9, 2016 The Medicines Company (NASDAQ:MDCO) reported its business and financial results for the first quarter ended March 31, 2016 (Press release, Medicines Company, MAY 9, 2016, View Source;p=RssLanding&cat=news&id=2166297 [SID:1234512129]).

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During the first quarter of 2016, the Company has:

PCSK9si (PCSK9 synthesis inhibitor): Continued on pace to recruit up to 480 patients in the ORION-1 clinical program, a Phase 2, placebo-controlled, double-blind, randomized trial to test the efficacy, safety and durability of a range of doses in patients with atherosclerotic cardiovascular disease; we anticipate completion of the trial by the end of 2016.
MDCO-216: Advanced enrollment of patients in the MILANO-PILOT study evaluating the drug’s effects on atherosclerotic plaque burden; trial is set to enroll 120 evaluable patients, with the first 40 patients expected to be analyzed around mid-year 2016;
ABP-700: Transitioned to Phase 2 clinical development with the expectation of enrolling patients for the first study of a global procedural sedation colonoscopy program by end of second quarter; with continued success, we expect to launch Phase 3 clinical testing in 2017;
CARBAVANCE: Announced the granting of fast track status and the anticipated completion of Phase 3 clinical trials during second half 2016; anticipate filing NDA and MAA by end of year;
Revenues for newly- launched products (Kengreal, Cleviprex, Orbactiv, Minocin IV and Ionsys) increased 161% to $10.9 million in the first quarter of 2016 over the same period in 2015.
The Company announced earlier today that it has entered into a definitive agreement to sell its non-core cardiovascular products—Cleviprex (clevidipine), Kengreal (cangrelor) and its rights to Argatroban for Injection—to Chiesi USA, Inc. and its parent company, Chiesi Farmaceutici S.p.A., for up to $792 million, consisting of $260 million in cash payable at closing, up to $480 million in sales-based milestone payments, the assumption by Chiesi of up to $50 million in milestone payment obligations and approximately $2 million for product inventory. The transaction, which is subject to customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, is expected to close early in the third quarter of 2016.

Clive Meanwell, MD, PhD, Chief Executive Officer of The Medicines Company, stated: "The divestiture of our non-core cardiovascular products will enable us to drive the continued development of our potential blockbuster R&D products without diluting our shareholders. Each of our four products in development have critical data milestones which we expect will be unveiled over the course of the year. In addition to completing and reporting data for the ORION-1 Phase 2 clinical trial of PCSK9si, we plan to initiate ORION-2, a Phase 2 study in familial homozygous hypercholesterolemia patients during 2016. For MDCO-216, we expect to secure clinical re-proof of concept from the MILANO-PILOT study. Finally, we expect to complete and report data for the Phase 3 registrational trial of Carbavance, as well as the Phase 2 trial of ABP-700. We look forward to sharing these critical updates throughout the year."

First-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $50.3 million for the first quarter of 2016 compared to $110.1 million in the first quarter of 2015. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $16.9 million in the first quarter of 2016 compared to $100.7 million in the first quarter of 2015, with net product sales in the United States decreasing to $13.2 million in the first quarter of 2016 from $95.1 million in the first quarter of 2015 driven by the loss of Angiomax exclusivity in July 2015. Included in total net revenue for the first quarter of 2016 is $18.9 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Other products including Cleviprex, Argatroban for Injection, Minocin for Injection, Orbactiv, Ionsys and Kengreal recorded sales of $14.5 million during the first quarter of 2016 compared to $9.4 million in the first quarter of 2015.

The net loss from continuing operations attributable to The Medicines Company for the first quarter of 2016 was $90.3 million, or $1.31 per share, compared to net income from continuing operations attributable to The Medicines Company of $4.4 million, or $0.07 per share, for the first quarter of 2015. Adjusted net loss(1) from continuing operations attributable to The Medicines Company for the first quarter of 2016 was $71.2 million, or $1.03(1) per share, compared to adjusted net loss(1) from continuing operations attributable to The Medicines Company of $0.1 million for the first quarter of 2015.

First-Quarter 2016 Financial Summary from Discontinued Operations

In the first quarter of 2016, the Company completed the sale of its hemostasis products. The net loss for the first quarter of 2016 from discontinued operations attributable to The Medicines Company was $2.1 million, or $0.03 per share, compared to net income from discontinued operations attributable to The Medicines Company for the first quarter of 2015 of $0.7 million, or $0.01 per share.

(1) Adjusted net loss and adjusted loss per share from continuing operations attributable to The Medicines Company are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss Per Share sections of this release for explanations of the amounts excluded and included to arrive at adjusted net loss and adjusted loss per share amounts.

As of March 31, 2016, the Company had $430 million in cash and investments compared to $373 million at the end of 2015.

On May 9, 2016 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the first quarter of 2016 and provided a corporate update on its priorities for 2016 (Filing, 8-K, Apricus Biosciences, MAY 9, 2016, View Source [SID:1234512412]). Apricus will hold a previously announced webcast this morning at 8:00 am PDT with Edward D. Kim, M.D., a member of the Company’s Scientific Advisory Board and a Vitaros clinical investigator, to discuss the Vitaros opportunity as part of the Company’s corporate activities concurrent with the American Urological Association’s 2016 Annual Meeting, May 6 – 10 in San Diego. Please join the webcast at www.apricusbio.com to view the presentation slides or, to participate by telephone, dial (877) 841-3961 (Domestic) or (201) 689-8589 (International). The conference ID number is 13633850.

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"In March, we sharpened our focus on growth of the Vitaros brand, as we streamlined our organization in an effort to align our corporate strategy and our financial resources with the goal of achieving profitability in 2017," stated Richard W. Pascoe, Chief Executive Officer. "Importantly, we experienced record Vitaros royalties in Europe in the first quarter of 2016 and we continue to have a productive dialogue with the Food and Drug Administration ("FDA") regarding the Vitaros New Drug Application ("NDA") resubmission content and format. As such, we remain on track to resubmit the NDA for Vitaros U.S. in the third quarter of 2016 with an approval decision expected after a six month review period. Finally, we will continue to work closely with our partners to grow Vitaros revenue by supporting additional regulatory approvals and launches, licensing additional territories, and leveraging our existing partnerships to help ensure Vitaros is actively commercialized in all approved territories."

First Quarter Highlights and Recent Developments

Apricus recently updated its corporate goals to focus on increasing Vitaros’ value through the fostering and expansion of its commercial partnerships, in the U.S. and globally, and strengthening the Company’s financial position. First quarter and recent highlights include:

• Closed on a $10 million registered direct offering with certain institutional investors, including existing investors Sarissa Capital and Aspire Capital;

• Reported top-line Phase 2b data for fispemifene in symptomatic secondary hypogonadism that failed to achieve statistical significance in key clinical benefit endpoints and abandoned further clinical activities surrounding fispemifene; and

• Expanded the Company’s exclusive distribution agreement with Ferring Pharmaceuticals to market Vitaros in the United Kingdom as part of the Company’s ongoing initiative to consolidate Vitaros territories with existing partners in an effort to maximize efficiencies and revenue.

2016 Priorities

Apricus is focused on achieving the following key strategic objectives:

Vitaros* (alprostadil)

• Continue implementation of the U.S. regulatory approval strategy to address the safety and manufacturing issues raised by the FDA in the original Vitaros NDA submission, with an NDA resubmission on target for the third quarter of 2016;

• Continue to support the Company’s ex-U.S. partners’ efforts to increase revenue in countries where partners have launched Vitaros, seek solutions to ensure that Vitaros is available to patients in every country where it is approved but not currently marketed, support new commercial launches by the Company’s partners and assist the Company’s partners in obtaining additional regulatory approvals in their respective territories; and

• Continue to generate the required data in 2016 to support delivery device improvements and related regulatory submission(s) with a priority to support the U.S. NDA resubmission of the refrigerated version of Vitaros.

RayVa (alprostadil)

• Complete the formulation development for at-home dosing;

• Finalize the Phase 2b study protocol;

• Explore Orphan Drug Designation in the U.S. and EU; and

• Explore global or regional partnerships prior to initiating the Phase 2b study.

First Quarter Financial Results

Revenue during the quarter ended March 31, 2016 was $0.6 million, compared to revenue of $0.5 million during the first quarter of 2015. Revenue during the quarter ended March 31, 2016 was comprised of $0.4 million in royalty revenues, an increase of $0.3 million or 317% over the quarter ended March 31, 2015. Revenue during the quarter ended March 31, 2015 included $0.4 million in license fee revenue related to the expansion of the Company’s license agreement with Sandoz to commercialize Vitaros in certain Asian and Pacific countries. Basic net loss for the quarter ended March 31, 2016 was $2.5 million, or basic loss per share of $0.05, compared to a net loss of $6.4 million, or $0.13 per share for the first quarter of 2015. Reducing the net loss for the quarter ended March 31, 2016 was a non-cash change in the fair value of the Company’s warrant liability in the amount of $2.6 million.

As of March 31, 2016, cash and cash equivalents totaled $6.9 million, compared to $3.9 million as of December 31, 2015.

2016 Financial Outlook

Early in the second quarter of 2016, Apricus reduced its staff, including the executive team, by approximately 30%, decreased the size of the Board by one member and reduced the Board’s cash compensation. Apricus plans to continue to reduce operating expenses (excluding non-cash stock-based compensation expense and depreciation expense), with a goal of achieving reductions of approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses (excluding non-cash stock-based compensation expense and depreciation expense).

In 2016, Apricus expects to continue to generate cash from milestone or licensing payments and royalty revenues from its partners’ sales of Vitaros. Apricus will also continue to pursue out-licensing opportunities for Vitaros in Asia-Pacific. Apricus’ expenditures will include minimal costs for the preparatory Phase 2b clinical development of RayVa, as well as costs for activities associated with supporting the regulatory approval of Vitaros in the U.S. and the commercialization of Vitaros in Europe.

On May 9, 2016 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the first quarter ended March 31, 2016 (Press release, Dynavax Technologies, MAY 9, 2016, View Source [SID:1234512109]).

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The Company had $166.8 million in cash, cash equivalents and marketable securities as of March 31, 2016, compared to $196.1 million at December 31, 2015. The net loss for the first quarter of 2016 was $27.0 million, compared to $26.2 million for the first quarter of 2015.

First Quarter Financials

Total revenues for the three months ended March 31, 2016 increased by $0.3 million, or 50%, compared to the same period in 2015.

Research and development expenses for the first quarter decreased by $2.2 million, or 10%, compared to the same period in 2015, reflecting an increase in employee headcount and activities in preparation for the anticipated commercial launch of HEPLISAV-B and a reduction in outside services expense due to lower activity related to HBV-23 following its completion in the fourth quarter of 2015.

General and administrative expenses for the three months ended March 31, 2016, increased by $3.3 million, or 68%, compared to the same period in 2015, as we added headcount and addressed information technology systems and other infrastructure needs in preparation for the anticipated commercial launch of HEPLISAV-B.

The net loss for the quarter ended March 31, 2016 was $27.0 million, or $0.70 per basic and diluted share compared to $26.2 million, or $0.97 per basic and diluted share for the quarter ended March 31, 2015.

Recent Progress

At the end of the quarter, the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for HEPLISAV-B, the company’s vaccine for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established December 15th as the Prescription Drug User Fee Act (PDUFA) action date for the BLA.

"We are focused on working with the FDA to obtain approval of HEPLISAV-B before year end and on preparing for launch, including preparation for an advisory panel in case one is called, hiring of key commercial personnel, market and pricing research and manufacturing of launch inventory," said Dynavax Chief Executive Officer, Eddie Gray.

In April, we reported additional details from the HBV-23 pivotal Phase 3 HEPLISAV-B trial at the National Foundation for Infectious Diseases’ (NFID) 19th Annual Conference on Vaccine Research (ACVR).

Also in April, we presented encouraging additional data from Part 1 of the Phase 1/2 study evaluating our lead immunotherapy product candidate, SD-101, in lymphoma patients. The clinical data, along with preclinical SD-101 data, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.