On August 9, 2016 Mylan N.V. (NASDAQ, TASE: MYL) reported its financial results for the quarter and six months ended June 30, 2016 (Press release, Mylan, AUG 9, 2016, View Source [SID:1234514570]).

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Second Quarter 2016 Financial Highlights
Total revenues of $2.56 billion, up 8% compared to the prior year period

Generics segment third party net sales of $2.14 billion, up 4% compared to the prior year period

Specialty segment third party net sales of $402.5 million, up 33% compared to the prior year period

Current quarter total revenues were not significantly impacted by the effect of foreign currency translation

U.S. GAAP diluted earnings per ordinary share ("EPS") of $0.33, up 3% compared to the prior year period primarily due to higher sales and gross margins, partially offset by increased non-operating expenses driven mainly by certain Meda transaction related acquisition and financing costs

Adjusted diluted earnings per ordinary share ("adjusted EPS") of $1.16, up 28% compared to the prior year period

Six Months Ended June 30, 2016 Financial Highlights
Total revenues of $4.75 billion, up 12% compared to the prior year period

Generics segment third party net sales of $4.07 billion, up 10% compared to the prior year period

Specialty segment third party net sales of $650.4 million, up 27% compared to the prior year period

The unfavorable impact of foreign currency translation on current year total revenues was approximately $33 million, or 1%

U.S. GAAP diluted EPS of $0.36, down 22% compared to the prior year period primarily due to higher operating expenses, driven mainly by certain Meda transaction related acquisition and financing costs

Adjusted EPS of $1.92, up 19% compared to the prior year period

Mylan CEO Heather Bresch commented, "Our strong second quarter results delivered year-over-year total revenue growth of 8% and adjusted EPS growth of 28%. This solid performance, which included continued strength in our generics business and double digit revenue growth in our Specialty business, yet again underscores the strategic value of Mylan’s diversification and scale as well as our differentiation within our industry. Given our performance to date this year and our current trajectory, we are committed to our 2016 adjusted EPS guidance range of $4.85 to $5.15.

"We also are very excited about the completion of our Meda transaction, as well as the Renaissance topicals transaction that we completed in June, which continue to build on our unique global platform to create even greater scale, breadth, diversity and access across products, geographies and sales channels. These transactions also further strengthen our already very strong cash flows. We see significant opportunities to further differentiate Mylan for our customers, patients and other stakeholders as we bring these assets together."

Total Revenues

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Three Months Ended

Six Months Ended

June 30,

June 30,
(Unaudited; in millions)
2016

2015

Percent
Change

2016

2015

Percent
Change
Total Revenues
$
2,560.7

$
2,371.7

8%

$
4,752.0

$
4,243.4

12%
Generics Third Party Net Sales
2,137.4

2,055.1

4%

4,065.6

3,698.7

10%
North America*
1,010.0

948.5

6%

1,929.7

1,803.5

7%
Europe
604.2

571.0

6%

1,191.9

977.3

22%
Rest of World*
523.2

535.6

(2)%

944.0

917.9

3%
Specialty Third Party Net Sales
402.5

301.9

33%

650.4

512.9

27%
Other Revenues
20.8

14.7

41%

36.0

31.8

13%
*Beginning in the first quarter of 2016, the Company reclassified sales from its Brazilian operation from Rest of World to North America. The amount reclassified for the three and six months ended June 30, 2015 was approximately $11.1 million and $21.3 million, respectively.
Second Quarter 2016 Financial Results
Total Revenue
Generics segment third party net sales were $2.14 billion for the quarter, an increase of 4% when compared to the prior year period. Generics third party net sales were not significantly impacted by the effect of foreign currency translation in the second quarter of 2016.
Third party net sales from North America were $1.01 billion for the quarter, an increase of 6% when compared to the prior year period. This increase was principally due to net sales from significant new products launched since July 1, 2015 ("new products") as a result of leveraging our strong global platform, partially offset by lower pricing and volumes on existing products. The unfavorable impact of foreign currency translation on current period third party net sales was approximately $4.8 million, or 1% within North America.
Third party net sales from Europe were $604.2 million for the quarter, an increase of 6% when compared to the prior year period. This increase was primarily the result of net sales from new products combined with higher volumes on existing products, while pricing was essentially flat in the current period as a result of our diversified product portfolio. The favorable impact of foreign currency translation on current period third party net sales was approximately $5.6 million, or 1% within Europe.
Third party net sales from Rest of World were $523.2 million for the quarter, a decrease of 2% when compared to the prior year period. New product introductions across the region and higher sales in Japan and emerging markets positively impacted sales in the quarter. Lower pricing and sales volumes in the region, including the anti-retroviral ("ARV") franchise, unfavorably impacted third party net sales. However, sales within our ARV franchise progressively improved throughout the quarter as HIV tender volumes increased, resulting in sales growth on a sequential basis of more than 30% compared to the first quarter of 2016. Third party net sales from Rest of World were not significantly impacted by the effect of foreign currency translation during the second quarter of 2016.
Specialty segment third party net sales were $402.5 million for the quarter, an increase of 33% when compared to the prior year period. This increase was primarily the result of higher unit volumes and the realization of the benefits of customer contract negotiations over the last several quarters related to the EpiPen Auto-Injector, and higher sales of the Perforomist Inhalation Solution and ULTIVA.
Total Gross Profit
Gross profit was $1.17 billion and $1.01 billion for the second quarter of 2016 and 2015, respectively. Gross margins were 46% and 43% in the second quarter of 2016 and 2015, respectively. Adjusted gross profit was $1.45 billion and adjusted gross margins were 56% for the quarter compared to adjusted gross profit of $1.28 billion and adjusted gross margins of 54% in the prior year period. Gross margins and adjusted gross margins were both positively impacted primarily by new product introductions and favorable Specialty sales in the second quarter of 2016.
Total Profitability
Earnings from operations were $410.9 million for the quarter, an increase of 49% from the comparable prior year period. This increase was primarily due to higher revenues and higher gross profit.
R&D expense increased from the comparable prior year period due to the continued development of our respiratory, insulin and biologics programs and expenses incurred during the current quarter related to the Company’s collaboration with Momenta Pharmaceuticals, Inc. ("Momenta"). SG&A expense increased from the comparable prior year period as we invested in our continued growth. These increases were partially offset by decreases in consulting and professional services expense and legal expense due to higher acquisition related costs incurred in the prior year period.
U.S. GAAP net earnings attributable to Mylan N.V. ordinary shareholders ("net earnings") increased by $0.6 million to $168.4 million for the quarter ended June 30, 2016, as compared to $167.8 million for the prior year period. Second quarter 2016 net earnings were negatively impacted by increased non-operating expenses including unrealized mark-to-market losses on the Company’s SEK denominated foreign currency contracts and the write off of financing fees related to the termination of the Bridge Credit Agreement originally entered into on February 10, 2016 (the "2016 Bridge Credit Agreement") in connection with Mylan’s public offer to the shareholders of Meda to acquire all of the outstanding shares of Meda (the "Offer"). U.S. GAAP diluted EPS increased from $0.32 to $0.33 as a result of higher earnings from operations and a lower average share count, partially offset by higher non-operating expenses. Adjusted net earnings increased by $118.1 million to $592.4 million compared to $474.3 million for the prior year period. Adjusted EPS increased 28% to $1.16 compared to $0.91 in the prior year period.
EBITDA, which is defined as net earnings (excluding the non-controlling interest and losses from equity method investees) plus income taxes, interest expense, depreciation and amortization, was $621.7 million for the quarter ended June 30, 2016, and $558.3 million for the comparable prior year quarter. After adjusting for certain items as further detailed in the reconciliation below, adjusted EBITDA was $821.4 million for the quarter ended June 30, 2016 and $693.5 million for the comparable prior year quarter.
Six Months Ended June 30, 2016 Financial Results
Total Revenue
Generics segment third party net sales were $4.07 billion for the six months ended June 30, 2016, an increase of 10% when compared to the prior year period. The unfavorable impact of foreign currency translation on Generics third party net sales was approximately $32.7 million, or 1% for the six months ended June 30, 2016.
Third party net sales from North America were $1.93 billion for the six months ended June 30, 2016, an increase of 7% when compared to the prior year period. This increase was principally due to net sales from significant new product introductions as a result of our strong global platform, and to a lesser extent, the two additional months of net sales from our established products ("incremental established products sales") when compared to the six months ended June 30, 2015. This increase was partially offset by lower pricing and volumes on existing products. The unfavorable impact of foreign currency translation on the current period third party net sales was approximately $12.0 million or 1% within North America.
Third party net sales from Europe were $1.19 billion for the six months ended June 30, 2016, an increase of 22% when compared to the prior year period. This increase was primarily the result of the incremental established products sales, and to a lesser extent, net sales from new products. In addition, there were higher volumes on existing products, while pricing was essentially flat in the first half of 2016 as a result of our diversified product portfolio. Third party net sales from Europe were not significantly impacted by the effect of foreign currency translation during the six months ended June 30, 2016.
Third party net sales from Rest of World were $944.0 million for the six months ended June 30, 2016, an increase of 3% when compared to the prior year period. This increase was primarily driven by the incremental established products sales, and to a lesser extent, new product introductions, as well as higher sales in Japan and emerging markets. These increases were partially offset by lower pricing and sales volumes in the region, including the ARV franchise. However, sales within our ARV franchise progressively grew throughout the first half of the year, and on a sequential basis second quarter sales increased over 30% from the first quarter of 2016. The unfavorable impact of foreign currency translation on current year third party net sales was approximately $18.4 million, or 2% within Rest of World.
Specialty segment third party net sales were $650.4 million for the six months ended June 30, 2016, an increase of 27% when compared to the prior year period. This increase was primarily the result of higher unit volumes and the realization of the benefits of customer contract negotiations over the last several quarters related to the EpiPen Auto-Injector, and higher sales of the Perforomist Inhalation Solution and ULTIVA.

Total Gross Profit
Gross profit was $2.08 billion and $1.84 billion for the six months ended June 30, 2016 and 2015, respectively. Gross margins were 44% and 43% for the six months ended June 30, 2016 and 2015, respectively. Gross margins were positively impacted primarily by new product introductions and favorable Specialty sales, partially offset by higher amortization expense due to acquisitions completed in 2015. Adjusted gross profit was $2.63 billion and adjusted gross margins were 55% for the six months ended June 30, 2016 compared to adjusted gross profit of $2.27 billion and adjusted gross margins of 54% in the prior year period. Adjusted gross margins were positively impacted primarily by new product introductions and favorable Specialty sales in the first half of 2016.

Total Profitability
Earnings from operations were $516.5 million for the six months ended June 30, 2016, an increase of 18% from the comparable prior year period. This increase was primarily due to higher revenue, including third party net sales growth of 10% and 27% in the Generics and Specialty segments from the comparable prior year period, respectively, and higher gross profit.

R&D expense for the six months ended June 30, 2016 increased from the comparable prior year period due to an upfront payment to Momenta for $45.0 million and additional expenses incurred in the current period related to the Company’s collaboration agreement. In addition, R&D expense increased due to the two additional months of expense related to our established products in the current year and our continued investment in the development of our respiratory, insulin and biologics programs. SG&A expense increased from the comparable prior year period principally due to the two additional months of expense related to our established products in the current year. These increases were partially offset by decreases in consulting and professional services expense and legal expense due to higher acquisition related costs incurred in the prior year period.

U.S. GAAP net earnings decreased by $42.1 million to $182.3 million for the six months ended June 30, 2016, compared to $224.4 million for the prior year period. U.S. GAAP diluted EPS decreased from $0.46 to $0.36 as a result of higher operating expenses, including higher amortization expense related to acquisitions completed during 2015, unrealized mark-to-market losses related to the Company’s SEK denominated foreign currency contracts, the write off of financing fees related to the termination of the 2016 Bridge Credit Agreement and a higher average share count due to the impact of ordinary shares issued in the prior year in the transaction in which Mylan N.V. acquired Mylan Inc. and Abbott Laboratories’ non-U.S. developed markets specialty and branded generics business (the "EPD Transaction"). Adjusted net earnings increased by $195.3 million to $978.7 million for the six months ended June 30, 2016 compared to $783.4 million for the prior year period. Adjusted EPS increased 19% to $1.92 for the six months ended June 30, 2016 compared to $1.62 in the prior year period.

EBITDA was $1.04 billion for the six months ended June 30, 2016, and $898.8 million for the comparable prior year period. After adjusting for certain items as further detailed in the reconciliation below, adjusted EBITDA was $1.41 billion for the six months ended June 30, 2016 and $1.20 billion for the comparable prior year period.

Cash Flow
Net cash provided by operating activities was $497.1 million for the six months ended June 30, 2016 compared to $381.7 million for the prior year period. The increase in net cash provided by operating activities was primarily the result of higher earnings from operations. Capital expenditures were approximately $121 million for the six months ended June 30, 2016 compared to approximately $122 million for the comparable prior year period. Adjusted cash provided by operating activities was $686.5 million for the six months ended June 30, 2016 compared to $489.9 million for the prior year period. Adjusted free cash flow, defined as adjusted cash provided by operating activities less capital expenditures, was $565.5 million for the six months ended June 30, 2016, compared to $367.9 million in the prior year period.

On August 9, 2016 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial and operational results for the quarter ended June 30, 2016 (Filing, Q2, Lipocine, 2016, AUG 9, 2016, View Source [SID:1234514569]).

Quarterly and Recent Highlights

· Received a Complete Response Letter ("CRL") from the United States Food and Drug Administration ("FDA") regarding its New Drug Application ("NDA") for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency or absence of endogenous testosterone, also known as hypogonadism. The next step will be to request a meeting with the FDA to understand more fully the issues raised in the CRL and to agree on a path forward to achieve approval of LPCN 1021.

· Added to the Russell 3000 and Russell Global Indexes.

· Presented clinical data for LPCN 1021 at the 2016 American Urological Association Annual Meeting.

"Our focus remains on evaluating the content of the CRL, including the FDA recommended actions, to bring our NDA for LPCN 1021 into a position for approval. We remain committed to bringing LPCN 1021 to patients who will benefit from its intended use," said Dr. Mahesh Patel, Chairman, President and CEO of Lipocine. "In addition, we continue to advance the progress our other pipeline products, LPCN 1107 and LPCN 1111, with updates expected in the coming months."

Second Quarter 2016 Financial Results

Lipocine reported a net loss of $5.8 million, or $0.32 per diluted share, for the second quarter of 2016, compared with a net loss of $4.2 million, or $0.26 per diluted share, for the second quarter of 2015.

For the second quarter of 2016, research and development expenses were $2.6 million, compared with $3.2 million for the second quarter of 2015. The decrease was primarily due to decreased contract research organization and consultant costs, partially offset by increased pre-commercialization manufacturing expenses related to LPCN 1021.

For the second quarter of 2016, general and administrative expenses were $3.2 million, compared with $1.1 million for the second quarter of 2015. The increase was primarily due to increased costs related to business development, market research and pre-commercialization activities related to LPCN 1021 as well as increased personnel costs.

As of June 30, 2016, Lipocine had cash, cash equivalents and marketable investment securities of $32.9 million, compared with cash and cash equivalents of $44.8 million as of December 31, 2015.

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On August 9, 2016 Galectin Therapeutics Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, reported financial results for the three and six months ended June 30, 2016 (Filing, Q2, Galectin Therapeutics, 2016, AUG 9, 2016, View Source [SID:1234514567]). These results are included in the Company’s Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
Summary of Key Development Programs, Updates and Anticipated Milestones

• Completed recruitment in a Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with cirrhosis (stage 4) (the NASH-CX trial), wherein patient recruitment was completed slightly ahead of our original expectations

• Completed enrollment in Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis (stage 3) (the NASH-FX trial)

• Positive preclinical results were presented at the American Thoracic Society (ATS) 2016 International Conference in which GR-MD-02 had shown a positive effect on vascular remodeling in an animal model of pulmonary arterial hypertension (PAH)

• Presented interim results from an exploratory, open-label, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis in which patients showed significant improvement in their plaque psoriasis

Management Commentary
"We are very pleased with the significant progress achieved this quarter completing enrollment in two important clinical trials, gaining further global protection of our intellectual property, and presenting further evidence of the positive effects of GR-MD-02 in new and exciting applications," said Peter G. Traber, M.D., president, chief executive officer and chief medical officer of Galectin Therapeutics. "Most immediately, with enrollment in our NASH-FX trial in NASH patients with advanced fibrosis (stage 3) having been completed on schedule in May, we are on pace to report top-line data assessing the efficacy of GR-MD-02 by the end of September. And, with recruitment also completed for our Phase 2 NASH-CX trial, we will be able to assess the efficacy of GR-MD-02 in up to 156 patients with non-alcoholic steatohepatitis (NASH) with cirrhosis. Patient recruitment for this trial was completed slightly ahead of our original expectations and we anticipate to report top line results in December 2017, as previously planned."
With its NASH trials investigating liver applications, Galectin is also exploring other applications of its lead compound. This quarter, the Company received encouraging results on two early stage studies. In an early stage investigation of applicability to vascular remodeling in pulmonary arterial hypertension (PAH), investigators from the Vascular Biology Center and the Department of Pharmacology and Toxicology at Augusta University presented data at the American Thoracic Society (ATS) 2016 International Conference, in which GR-MD-02 had shown a positive effect in an animal model of PAH. David Fulton, Ph.D., director of the Vascular Biology Center at Augusta University, noted that the alterations in cardiopulmonary function and vascular proliferation, as well as in fibrosis were significantly attenuated by in vivo treatment with specific gal-3 inhibitors, with our lead compound obviously being a gal-3 inhibitor.
Separately, interim results from an exploratory, open-label, Phase 2a clinical trial with GR-MD-02 in patients with moderate-to-severe plaque psoriasis, in which four patients who received 12 weeks of therapy had significant improvement in their plaque psoriasis, led to the extension of the treatment duration to 24 weeks. These interim results demonstrate a potentially important clinical effect of GR-MD-02 in clearing moderate-to-severe plaque psoriasis.

In the quarter, the Company also received Notice of Allowance from the Australian Government Patent Office for patent application for "Composition of Novel Carbohydrate Drug for Treatment of Human Diseases" that, from the date they are issued and through 2032, will extend coverage of GR-MD-02 to Australia to treat patients at risk of non-alcoholic steatohepatitis (NASH), fibrosis, inflammatory and autoimmune disorders in which galectins are at least in part involved. The allowance of these claims further strengthens the protection of the intellectual property behind GR-MD-02. This is but one of more than 50 patent applications the Company has pending in 10 foreign countries, all of which are viewed as significant markets for the active pharmaceutical ingredient (API) or the manufacture of the API. When issued, this patent will augment Galectin’s current intellectual property portfolio for treatment of liver fibrosis, kidney fibrosis, lung fibrosis or heart fibrosis.
The investigator-sponsored trials utilizing GR-MD-02 in combination with checkpoint inhibitors being conducted by Galectin’s partners at the Providence Portland Cancer Center, who are also funding the studies, continue to advance. The study of GR-MD-02 in combination with Yervoy and Keytruda in two separate Phase 1b trials in patients with metastatic melanoma is expected to yield data from the Yervoy combination trial by the end of the year."
Galectin Therapeutics is exhibiting a steady pattern of progress throughout and across the organization not only with its primary investigations, but in new and evolving applications as well. As such, its addressable market increases from the still very large $35 billion, understood to be available just from the treatment of NASH, to an even larger sum when considering psoriasis, PAH and potentially other maladies. Each of these efforts is based on a very systematic approach to advancing development whereby Galectin is moving methodically along the development path while simultaneously branching out into adjacent and complementary markets whenever the science warrants a new investigation. Allied with very strong medical professionals who are conducting these trials and investigations, Galectin’s management team is doing everything within its power to optimize the value of the organization, its intellectual property, and the other assets at its disposal.
Financial Results
For the three months ended June 30, 2016, the Company reported a net loss applicable to common stockholders of $5.8 million, or $0.20 per share, compared with a net loss applicable to common stockholders of $4.9 million, or $0.21 per share, for the three months ended June 30, 2015. The increase is largely due to higher research and development expenses primarily related to the Phase 2 clinical program in NASH.

Research and development expense for the three months ended June 30, 2016 was $4.2 million, compared with $2.6 million for the three months ended June 30, 2015. The increase primarily relates to costs for the Phase 2 clinical trials begun in 2015, partially offset by lower preclinical costs.
General and administrative expense for quarter was $1.3 million, compared with $2.1 million for the prior year, with the decrease being to severance and non-cash stock compensation and lower legal and accounting fees.
As of June 30, 2016, the Company had $18.0 million of non-restricted cash and cash equivalents. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through June 30, 2017.

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On August 9, 2016 Vical Incorporated (Nasdaq:VICL) reported financial results for the three and six months ended June 30, 2016 (Press release, Vical, AUG 9, 2016, View Source [SID:1234514566]). Net loss for the second quarter of 2016 was $1.3 million, or $0.14 per share, compared with a net loss of $2.8 million, or $0.30 per share, for the second quarter of 2015. Revenues for the second quarter of 2016 were $4.1 million, compared with revenues of $4.2 million for the second quarter of 2015, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under the ASP0113 collaborative agreements. ASP0113 is Vical’s therapeutic vaccine designed to prevent cytomegalovirus (CMV) disease and associated complications in transplant recipients.

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Vical had cash and investments of $38.5 million at June 30, 2016. This cash balance does not include the $7.8 million in proceeds received from the Company’s recently completed private placement. The Company’s net cash use for the first six months of 2016 was $3.5 million, which was consistent with the Company’s guidance for the full year. The Company is projecting net cash burn for 2016 between $8 million and $11 million, which includes the cash burn associated with the planned initiation of the HSV-2 Phase 2 clinical program later this year.

Operational updates include:

ASP0113 CMV Vaccine

Recruitment in the multinational Phase 3 registration trial in 500 hematopoietic cell transplant (HCT) recipients is nearing completion with over 90% of the subjects enrolled. Astellas expects enrollment to be completed during the third quarter of 2016, with the top-line data expected to be available in the fourth quarter of 2017. The primary endpoint of this trial is a composite of overall mortality and CMV end organ disease. Vical and Astellas have made substantial progress in process validation activities for the manufacture of the bulk drug product in anticipation of a potential BLA filing in 2018.

One year follow up in the multinational Phase 2 trial in kidney transplant recipients is now complete. Astellas is completing the final verification of all outstanding data and expects to release the top-line trial results during the third quarter of 2016. The primary endpoint of this trial is the incidence of CMV viremia and the study is powered to show an approximately 50% reduction in CMV viremia at 1 year after transplantation. The study also includes a key clinically relevant secondary endpoint, incidence of CMV disease.
HSV-2 Therapeutic Vaccine

Vical plans to initiate a Phase 2 trial of its bivalent HSV-2 therapeutic vaccine during the second half of 2016. The randomized, double-blind, placebo-controlled trial will evaluate the safety and efficacy of the vaccine in approximately 225 otherwise healthy adults aged 18 to 50 years with symptomatic genital HSV-2 infection. Vical is confirming with the FDA the Phase 2 trial design, which is intended to evaluate the vaccine’s efficacy using clinical relevant endpoints rather than virologic endpoints.
VL-2397 Antifungal

Enrollment is ongoing in Vical’s first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial is intended to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of VL-2397 in healthy volunteers. The trial is expected to be completed by the end of 2016. Vical is working closely with its expert advisors and the FDA to design a Phase 2 efficacy study for VL-2397 in the treatment of patients with invasive aspergillosis. This fungal infection is associated with a high rate of mortality in immunocompromised patients, and represents a sizeable unmet medical need for new antifungal therapies.
Equity Investment by AnGes

On August 1, 2016, Vical announced an agreement by AnGes, MG, a partner and shareholder in Vical since 2006, to purchase approximately $7.8 million of Vical’s common stock in a private placement. The shares were sold at a price of $4.24 per share, the 90-day volume weighted average price of Vical’s common stock and a premium to the close on the prior trading day. With the new investment, AnGes’ equity position increased to approximately 18.6% of Vical’s outstanding shares. The transaction further strengthens Vical’s relationship with AnGes, which has a strategic interest in DNA vaccines, including one in its own pipeline, and which has demonstrated an appreciation for Vical’s DNA technology, and clinical, regulatory, and manufacturing expertise over the years.

On August 9, 2016 Portola Pharmaceuticals Inc. (NASDAQ:PTLA) reported a corporate update and reported its financial results for the quarter ended June 30, 2016 (Press release, Portola Pharmaceuticals, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194332 [SID:1234514564]).

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"We made significant progress in the second quarter to advance our goal of commercializing multiple medicines that could change current medical practices for treating patients with thrombotic disorders and hematological cancers," said Bill Lis, chief executive officer of Portola. "We expect more milestone momentum in the remainder of this year as we prepare for the anticipated U.S. commercial launch of AndexXaTM, which is currently on track to be our first marketed product. As a potential universal antidote for Factor Xa inhibitor anticoagulants, AndexXa may fulfill an unmet need for a specific reversal agent for Factor Xa inhibitor-treated patients who suffer life-threatening bleeding. During the quarter, we also presented and published full results of the Phase 3 APEX study of betrixaban. We believe these results support its potential approval and use as the first anticoagulant for extended-duration blood clot prevention in acute medically ill patients. We expect to submit the betrixaban NDA to the FDA later this year. Finally, we enrolled the first patients in our Phase 2a study of cerdulatinib, and anticipate presenting data on this promising compound at a medical meeting later this year."

Recent Achievements, Upcoming Events and Milestones

AndexXa (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening bleeding or when urgent surgery is required; designated a Breakthrough Therapy and an Orphan Drug by the U.S. Food and Drug Administration (FDA)

Preparing for a U.S. commercial launch; PDUFA date of August 17, 2016, under an FDA Accelerated Approval pathway
Manufacturing of Generation 1 supply at CMC Biologics on track for commercial launch; plan to initiate validation campaign for Generation 2 long-term supply at Lonza
Enrollment remains on track for the Phase 3b/4 ANNEXA-4 study
ANNEXA-4 interim data to be presented in a late-breaking science session at ESC Congress on August 30
Plan to submit a Marketing Authorization Application (MAA) with the European Medicines Agency in the third quarter of 2016
Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients; designated Fast Track status by the FDA

Presented full results of the pivotal Phase 3 APEX study in a late-breaking clinical trial session at the ISTH SSC Meeting; simultaneously published online in The New England Journal of Medicine
Plan to submit a New Drug Application and an MAA later this year
Expect to present additional APEX data at upcoming medical conferences later this year
Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

Presented new pharmacokinetic and pharmacodynamic outcomes data from the completed Phase 1 study at the ASCO (Free ASCO Whitepaper) Annual Meeting
Presented final results of the Phase 1 study at the EHA (Free EHA Whitepaper) Congress
Initiated enrollment in a Phase 2a study evaluating the safety and efficacy of cerdulatinib in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies
Expect to present initial Phase 2a data at a medical meeting later this year
Second Quarter 2016 Financial Results
Collaboration revenue earned under Portola’s collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Lee’s Pharmaceutical was $4.2 million for the second quarter of 2016 compared with $2.4 million for the second quarter of 2015. The increase in revenue was primarily due to a collaboration and license agreement that Portola entered into with BMS/Pfizer to develop and commercialize andexanet alfa in Japan and a clinical collaboration agreement that Portola entered into with Bayer to include its Factor Xa inhibitor in the andexanet alfa development program in Japan.

Total operating expenses for the second quarter of 2016 were $61.9 million compared with $61.2 million for the same period in 2015. Total operating expenses for the second quarter of 2016 included $7.6 million in stock-based compensation expense compared with $4.8 million for the same period in 2015.

Research and development expenses were $44.8 million for the second quarter of 2016 compared with $52.3 million for the second quarter of 2015. The decrease in research and development expenses was primarily due to lower development costs following the completion of enrollment in the APEX study of betrixaban and lower development costs related to cerdulatinib due to the timing of activities. These decreased costs were partially offset by an increase in costs to advance AndexXa and support early research programs.

Selling, general and administrative expenses for the second quarter of 2016 were $17.0 million compared with $8.9 million for the same period in 2015 as the Company increased headcount to support its growth and increased commercial launch preparation activities for AndexXa.

For the second quarter of 2016, Portola reported a net loss of $57.3 million, or $1.02 net loss per share, compared with a net loss of $58.3 million, or $1.12 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were approximately 56.4 million for the second quarter of 2016 compared with approximately 52.1 million for the same period in 2015.

As of June 30, 2016, cash, cash equivalents and investments totaled $353.6 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.