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 Laboratory Corporation of America Holdings (NYSE: LH) reported the commencement of its cash tender offer for all outstanding shares of the common stock of Sequenom, Inc. (NASDAQ: SQNM) for $2.40 per share (Press release, LabCorp, AUG 9, 2016, View Source;p=RssLanding&cat=news&id=2194107 [SID:1234514422]). The tender offer is being made by Savoy Acquisition Corp., a wholly owned subsidiary of LabCorp, pursuant to an offer to purchase, dated August 9, 2016. LabCorp and Sequenom previously announced that they entered into an agreement and plan of merger, dated as of July 26, 2016, for LabCorp to acquire Sequenom.

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The board of directors of Sequenom, Inc. has determined that the merger agreement, the offer and the merger are fair and advisable to, and in the best interests of Sequenom and its stockholders. The Sequenom board also agreed that the merger agreement shall be effected under Section 251(h) of the Delaware General Corporation Law, approved the merger agreement, the offer, the merger and the other transactions contemplated thereby, and recommended that Sequenom stockholders accept the offer and tender their shares in the offer.

The tender offer and any withdrawal rights are scheduled to expire at 12:01 a.m., New York City Time, on Wednesday, September 7, 2016, unless the tender offer is extended.

Following the successful completion of the tender offer, LabCorp expects to merge Savoy Acquisition Corp. into Sequenom without a vote of the stockholders of Sequenom, resulting in any shares not purchased in the tender offer being converted into the right to receive the same cash price per share as paid in the tender offer. The tender offer and the merger are subject to customary closing conditions set forth in the merger agreement, including the acquisition by Savoy Acquisition Corp. of a majority of Sequenom’s outstanding shares at the time of the consummation of the offer and the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. The closing of the acquisition is expected by year end.

The complete terms and conditions of the tender offer are set forth in the offer to purchase, letter of transmittal and other related materials filed with the Securities and Exchange Commission (SEC) on August 9, 2016 as exhibits to a tender offer statement on Schedule TO filed by LabCorp and Savoy Acquisition Corp. In addition, on August 9, 2016, Sequenom filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC related to the tender offer.

Important Additional Information Has Been Filed with the SEC

The tender offer described in this press release has commenced, but this press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell shares of Sequenom, Inc.’s common stock. The tender offer is being made pursuant to a tender offer statement and related materials (including the Offer to Purchase and the letter of transmittal). INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND RELATED MATERIALS (INCLUDING THE OFFER TO PURCHASE AND LETTER OF TRANSMITTAL) AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE TENDER OFFER BECAUSE THEY CONTAIN IMPORTANT INFORMATION. The tender offer statement on Schedule TO and related materials, including the offer to purchase and letter of transmittal, have been filed by Laboratory Corporation of America Holdings and Savoy Acquisition Corp. with the SEC and mailed to Sequenom stockholders. The solicitation/recommendation statement on Schedule 14D-9 has been filed by Sequenom, Inc. with the SEC and mailed to Sequenom stockholders. Investors and security holders may obtain a copy of these statements at no cost and other documents filed by Laboratory Corporation of America Holdings and Savoy Acquisition Corp. or Sequenom, Inc. with the SEC at the website maintained by the SEC at www.sec.gov. The tender offer statement and related materials, solicitation/recommendation statement, and such other documents may be obtained at no cost by directing such requests to Morrow Sodali Global, LLC, the information agent for the tender offer, at 1-203-658-9400 for banks and brokers or 1-800-662-5200 for shareholders and all others.

On August 9, 2016 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported its second quarter and first half financial results for 2016 (Press release, Intrexon, AUG 9, 2016, View Source [SID:1234514476]).

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Business Highlights and Recent Developments:

The U.S. Food and Drug Administration (FDA) published final finding of no significant impact and final environmental assessment on Oxitec’s OX513A self-limiting mosquito concluding that a field trial of the Friendly Aedes in Key Haven, Florida, will not result in a significant impact on the environment;
Expanded Oxitec’s ‘Friendly Aedes aegypti Project’ in Piracicaba, Brazil to an area in the city’s center covering 60,000 residents. Releases of Friendly Aedes, the mosquito that fights the primary vector of dengue, Zika and chikungunya, began in July;
Oxitec reported results from Piracicaba’s Epidemiologic Surveillance service which showed a 91% reduction of dengue fever cases registered in the 2015/2016 dengue-year as compared to the 2014/2015 period in the CECAP/Eldorado district, an area of 5,000 residents and the initial site of the ‘Friendly Aedes aegypti Project’;
Announced Grand Cayman will use Oxitec’s Friendly Aedes to suppress wild Aedes aegypti in an effort to help eliminate diseases transmitted by this mosquito. Releases of Friendly Aedes began in July;
Announced the formation of Intrexon Crop Protection (ICP), a wholly-owned subsidiary dedicated to bio-based control of agricultural pests and diseases through the utilization of Oxitec’s diverse self-limiting gene platform for species-specific insect control, as well as the ActoBiotics system for the expression of targeted biologicals for pest and disease management programs;
Introduced Florian technology, an "on-off" regulation switch system which exhibits the capability to regulate the timing of flowering, as well as selectively activate specific plant genes, through topical application of an activator. This technology demonstrates potential for enabling a variety of commercial applications in agriculture, and the Company will focus its initial efforts on near-to-market opportunities in turf, floral, and forage industries;
Announced amendments to Exclusive Channel Collaborations (ECCs) with ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) in the fields of oncology and graft-versus-host-disease to improve alignment. Operating profit rates payable to Intrexon from ZIOPHARM on products developed under these ECCs decrease from 50% to 20%, excluding the companies’ existing collaboration with Merck Serono, the biopharmaceutical division of Merck KGaA. Economics from any future sublicensing arrangements with third party collaborators will be split evenly. Intrexon received $120 million in ZIOPHARM preferred stock along with a monthly dividend of 1% payable in additional preferred shares;
Collaborator ZIOPHARM announced plans for a Phase I clinical trial utilizing autologous T cells transduced with lentivirus to express a CD33-specific chimeric antigen receptor (CAR) in patients with relapsed or refractory acute myeloid leukemia. This will be second trial initiated at The University of Texas MD Anderson Cancer Center under the research and development agreement among ZIOPHARM, Intrexon, and MD Anderson to expeditiously move promising treatments from bench to clinic;
Entered into an ECC with AD Skincare, Inc., backed by the Harvest Intrexon Enterprise Fund, sponsored by Harvest Capital Strategies, LLC, which will focus on developing an advanced delivery system for anti-aging active ingredients to be used in cosmetic formulations that are designed to reduce the appearance of certain signs of aging on human facial skin;
Collaborator Fibrocell Science, Inc. (NASDAQ: FCSC) initiated adult patient recruitment in its Phase I/II clinical trial of FCX-007 in June and during July reported the first two adult subjects had been enrolled. Fibrocell expects to commence dosing this year;
Two Intrexon collaborators’ gene therapy programs received Orphan Drug designation from the FDA: Fibrocell’s FCX-013 for the treatment of linear scleroderma and Agilis Biotherapeutics’ AGIL-FA for the treatment of Friedreich’s ataxia;
Exemplar Genetics announced the FDA exercised enforcement discretion in regard to its ExeGen low-density lipoprotein receptor miniswine, clearing this animal that enables superior translational research and better predictive efficacy for commercial use as a research model;
Intrexon’s subsidiary AquaBounty Technologies, Inc. (AIM: ABTU; OTC: AQBT) received approval from Health Canada for commercial sale of AquAdvantage Salmon (AAS) in Canada;
Appointed Geno Germano, a pharmaceutical executive with over 30 years of experience, to the new role of President, helping lead Intrexon’s management team and commercialization efforts;
Appointed Andrew J. Last, Ph.D., a seasoned executive with 30 years of experience spanning life sciences, including biotechnology, genomics, clinical diagnostics, pharmaceuticals and agrochemicals, as Chief Operating Officer, to oversee Intrexon’s multiple technology divisions and operating subsidiaries; and
Appointed distinguished life sciences executive Fred Hassan to Intrexon’s Board of Directors.
Second Quarter Financial Highlights:

Total revenues of $52.5 million, an increase of 17% over the second quarter of 2015;
Net loss of $49.1 million attributable to Intrexon, or $(0.42) per basic share, including non-cash charges of $44.0 million;
Adjusted EBITDA of $110.7 million, or $0.94 per basic share;
Cash consideration received for reimbursement of research and development services covered 59% of cash operating expenses (exclusive of operating expenses of consolidated subsidiaries);
Total consideration received for technology access fees, reimbursement of research and development services and products and services revenues covered 279% of consolidated cash operating expenses; and
Cash, cash equivalents, and short-term and long-term investments totaled $321.2 million, the value of investment in preferred stock totaled $120.0 million, and the value of marketable equity securities totaled $39.0 million at June 30, 2016.
First Half Financial Highlights:

Total revenues of $95.9 million, an increase of 22% over the first half of 2015;
Net loss of $113.5 million attributable to Intrexon, or $(0.97) per basic share, including non-cash charges of $94.6 million;
Adjusted EBITDA of $112.5 million, or $0.96 per basic share;
Cash consideration received for reimbursement of research and development services covered 57% of cash operating expenses (exclusive of operating expenses of consolidated subsidiaries); and
Total consideration received for technology access fees, reimbursement of research and development services and products and services revenues covered 184% of consolidated cash operating expenses.
"We began the year with great anticipation that 2016 will be a period in which we should demonstrate significant progress on several dimensions," commented Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, "and so far are tracking very well against our objectives. While continuing our trajectory of growing financial performance and capital efficiency, we have advanced many of our programs, achieving key scientific, developmental and regulatory milestones. In addition, our production and marketing plans around three mature yet game-changing assets – the Friendly Aedes mosquito, the Arctic apple and the AquAdvantage salmon – are being managed aggressively, and we look forward to the world enjoying the benefits of each of these unique, sustainable and environmentally responsible solutions to major problems."

Mr. Kirk concluded, "Considering the poignant moment in history that we occupy, one in which there is increasing recognition of the need for the engineering of biology to be responsibly practiced in order to solve an enormous number of world problems in areas such as healthcare, food, energy and the environment, our greatest need in order for Intrexon to play a leading role on this industrial and social vector, is the recruitment and development of great talent at every level of our organization – on our board, within our executive management team and in our labs that today span North America and Europe. In this regard, I am honored every day to work in partnership with our President, Geno Germano, the rest of our executive team and with so many brilliant and dedicated scientists and professionals throughout our organization. I believe that the world should expect great things from such a team, and I believe that they will deliver on these expectations. "

Second Quarter 2016 Financial Results Compared to Prior Year Period
Total revenues were $52.5 million for the quarter ended June 30, 2016 compared to $44.9 million for the quarter ended June 30, 2015, an increase of $7.6 million, or 17%. Collaboration and licensing revenues increased $10.3 million over the quarter ended June 30, 2015 due to (i) the recognition of deferred revenue for upfront payments received from the Company’s license and collaboration agreement with the biopharmaceutical business of Merck KGaA, which became effective in May 2015, and from other collaborations signed by Intrexon between July 1, 2015 and June 30, 2016; and (ii) increased research and development services for these collaborations and for the progression of programs or the addition of new programs with previously existing collaborators. Product revenues were $10.9 million for the quarter ended June 30, 2016 compared to $14.3 million for the quarter ended June 30, 2015, a decrease of $3.4 million, or 24%. The decrease in product revenues and gross margin thereon primarily relates to a decrease in the quantities of pregnant cows, livestock previously used in production and live calves sold due to lower customer demand for these products. The decreases were partially offset by an increase in the quantity of weaned calves sold due to higher customer demand. Service revenues were $13.9 million for the quarter ended June 30, 2016 compared to $13.3 million for the quarter ended June 30, 2015, an increase of $0.6 million, or 5%. The increase relates to an increase in the number of in vitro fertilization cycles performed due to higher customer demand.

Total operating expenses were $75.7 million for the quarter ended June 30, 2016 compared to $62.3 million for the quarter ended June 30, 2015, an increase of $13.4 million, or 22%. Research and development expenses increased $8.0 million, or 39%, due primarily to increases in (i) salaries, benefits and other personnel costs for research and development employees, (ii) lab supplies and consulting expenses, and (iii) depreciation and amortization. Salaries, benefits and other personnel costs increased $2.3 million due to (i) an increase in research and development headcount to support new and expanded collaborations and (ii) costs for research and development employees assumed in the Company’s acquisition of Oxitec Limited, or Oxitec, in September 2015. Lab supplies and consulting expenses increased $3.4 million as a result of (i) the progression into the preclinical phase with certain of Intrexon’s collaborators; (ii) the increased level of research and development services provided to the Company’s collaborators; and (iii) costs incurred as a result of the Company’s September 2015 acquisition of Oxitec. Depreciation and amortization increased $1.9 million primarily as a result of (i) the inclusion of a full quarter of depreciation and amortization on property and equipment and intangible assets acquired in the Company’s 2015 acquisitions, and (ii) amortization related to AquaBounty’s intangible assets upon regulatory approval in November 2015. Selling, general and administrative (SG&A) expenses increased $6.6 million, or 28%, over the second quarter of 2015. Legal and professional expenses increased $5.8 million due to (i) consulting expenses payable in shares of Intrexon’s common stock pursuant to the Company’s services agreement with Third Security, LLC, or Third Security, which the Company entered into in November 2015; (ii) expenses incurred to support domestic and international government affairs for regulatory and other approvals necessary to commercialize the Company’s products and services; (iii) increased legal fees incurred to defend ongoing litigation; and (iv) incremental costs incurred to support the ongoing operations of the Company’s 2015 acquisitions and other business development activities. These increases were partially offset by a decrease of $2.2 million for salaries, benefits and other personnel costs. Salaries, benefits and other personnel costs for SG&A employees decreased primarily due to a decrease in stock compensation and other compensation expenses resulting primarily from the departure of certain officers of the Company. These decreases were partially offset by increased headcount, including a new executive officer to support the Company’s expanding operations as well as the acquisition of Oxitec in September 2015.

First Half 2016 Financial Results Compared to Prior Year Period
Total revenues were $95.9 million for the six months ended June 30, 2016 compared to $78.7 million for the six months ended June 30, 2015, an increase of $17.2 million, or 22%. Collaboration and licensing revenues increased $19.6 million over the six months ended June 30, 2015 due to (i) the recognition of deferred revenue for upfront payments received from the Company’s license and collaboration agreement with the biopharmaceutical business of Merck KGaA, which became effective in May 2015, and from other collaborations signed by Intrexon between July 1, 2015 and June 30, 2016; and (ii) increased research and development services for these collaborations and for the progression of programs or the addition of new programs with previously existing collaborators. Product revenues were $19.4 million for the six months ended June 30, 2016 compared to $23.2 million for the six months ended June 30, 2015, a decrease of $3.8 million, or 16%. The decrease in product revenues and gross margin thereon primarily relates to a decrease in the quantities of pregnant cows, livestock previously used in production and live calves sold due to lower customer demand for these products. The decreases were partially offset by an increase in the quantity of weaned calves sold due to higher customer demand. Service revenues were $24.6 million for the six months ended June 30, 2016 compared to $23.2 million for the six months ended June 30, 2015, an increase of $1.4 million, or 6%. The increase relates to an increase in the number of in vitro fertilization cycles performed due to higher customer demand.

Total operating expenses were $159.7 million for the six months ended June 30, 2016 compared to $183.3 million for the six months ended June 30, 2015, a decrease of $23.6 million, or 13%. Research and development expenses declined $45.5 million, or 46%, due primarily to the inclusion in 2015 of a $59.6 million payment In common stock for an exclusive license to certain technologies owned by the University of Texas MD Anderson Cancer Center. This decrease was partially offset by increases in (i) salaries, benefits and other personnel costs for research and development employees, (ii) lab supplies and consulting expenses, and (iii) depreciation and amortization. Salaries, benefits and other personnel costs increased $4.6 million due to (i) an increase in research and development headcount to support new and expanded collaborations and (ii) costs for research and development employees assumed in the Company’s acquisition of Oxitec in September 2015. Lab supplies and consulting expenses increased $6.2 million as a result of (i) the progression into the preclinical phase with certain of Intrexon’s collaborators; (ii) the increased level of research and development services provided to the Company’s collaborators; and (iii) costs incurred as a result of the Company’s September 2015 acquisition of Oxitec. Depreciation and amortization increased $3.8 million primarily as a result of (i) the inclusion of a full period of depreciation and amortization on property and equipment and intangible assets acquired in the Company’s 2015 acquisitions and (ii) amortization related to AquaBounty’s intangible assets upon regulatory approval in November 2015. SG&A expenses increased $21.8 million, or 43%, over the six months of 2015. Salaries, benefits and other personnel costs for SG&A employees increased $3.8 million due to (i) increased headcount, including a new executive officer, to support the Company’s expanding operations; (ii) a full period of stock compensation expense for a company-wide option grant to employees in March 2015; and (iii) salaries, benefits and other personnel costs for employees assumed in the Company’s acquisition of Oxitec in September 2015. These increases were partially offset by (i) a decrease in stock compensation and other compensation expenses resulting primarily from the departure of certain officers of the Company. Legal and professional expenses increased $9.5 million primarily due to (i) consulting expenses payable in shares of Intrexon’s common stock pursuant to the Company’s services agreement with Third Security which the Company entered into in November 2015; (ii) expenses incurred to support domestic and international government affairs for regulatory and other approvals necessary to commercialize the Company’s products and services; (iii) increased legal fees incurred to defend ongoing litigation; and (iv) incremental costs incurred to support the ongoing operations of the Company’s 2015 acquisitions and other business development activities. In 2016, the Company also recorded $4.2 million in litigation settlement expenses arising from the entrance of a court order in Trans Ova Genetics, L.C.’s trial with XY, LLC.

Total other income (expense), net, was $(43.8 million) for the six months ended June 30, 2016 compared to $94.7 million for the six months ended June 30, 2015, a decrease of $138.5 million, or 146%. This decrease was attributable to the $81.4 million realized gain recognized upon the special stock dividend of all of Intrexon’s shares of ZIOPHARM to the Company’s shareholders in June 2015 and the decrease in fair value of the Company’s equity securities portfolio.

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 Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) ("Valeant" or the "Company") reported second quarter 2016 financial results (Press release, Valeant, AUG 9, 2016, http://ir.valeant.com/news-releases/2016/08-09-2016-110228006 [SID:1234514390]).

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"We continue to make progress towards stabilizing the organization," said Joseph C. Papa, chairman and chief executive officer. "We are also announcing a new strategic direction for Valeant today, which, at its heart has a mission to improve patients’ lives, and will involve reorganizing our company and reporting segments. I am continuously encouraged by the commitment of our employees who work hard daily, rebuilding our relationships with prescribers, patients and payors, and regaining the trust of our debt holders and shareholders. Although it will take time to implement and execute our turnaround plan, I am confident that we will show progress in the coming quarters."

Total Revenues
Total revenues decreased 11% to $2.42 billion in the second quarter of 2016 as compared to $2.73 billion in the second quarter of 2015, driven primarily by a decline in product sales revenues from our existing business, as well as negative foreign currency exchange impact, partially offset by incremental product sales revenues from acquisitions completed in 2015.

In the Developed Markets segment, revenues declined 14%, driven mainly by a decline in product sales revenue from our existing business, primarily as a result of lower average realized prices which were in turn impacted by higher managed care rebates, lower price appreciation credits, our fulfillment agreement with Walgreens, and higher group purchasing organization (GPO) rebates. These factors were partially offset by an increase in contribution from acquisitions completed in 2015, primarily from Salix Pharmaceuticals, Ltd. and certain assets of Dendreon Corporation.

In the Emerging Markets segment, revenues were flat as compared to the second quarter of 2015, primarily due to a small decline in the existing business and negative foreign currency exchange impact, which were partially offset by incremental product sales revenue from acquisitions completed in 2015.

Operating Expenses
Cost of goods sold were $647 million in the second quarter of 2016 as compared to $670 million in the second quarter of 2015, a decrease of 3% primarily due to a decline in sales volumes, partially offset by increased sales from acquisitions completed in 2015, primarily of Salix and Amoun Pharmaceutical Company S.A.E.

Selling, general and administrative expenses ("SG&A") were $672 million in the second quarter of 2016, as compared to $686 million in the second quarter of 2015. As a percentage of revenue, SG&A was 28% in the second quarter of 2016, as compared to 25% in the second quarter of 2015.

Research and development ("R&D") expenses were $124 million in the second quarter of 2016 as compared to $81 million in the second quarter of 2015, primarily due to the development programs related to the Company’s dermatology product portfolio, as well as spending on brodalumab and programs acquired in the Salix acquisition.

Net Income (Loss)
Net loss in the second quarter of 2016 was $302 million as compared to a net loss of $53 million in the second quarter of 2015. Adjusted net income (non-GAAP) in the second quarter of 2016 was $488 million as compared to $751 million in the second quarter of 2015.

Cash Flow
Cash flow from operations was $448 million in the second quarter of 2016 as compared to $411 million in the second quarter of 2015, an increase of 9% over the same period in 2015.

Business Development
We have taken steps to streamline our portfolio in the second quarter. We have sold, or agreed to sell, the brodalumab EU rights, Synergetics USA OEM business, and Ruconest for a total combined upfront payment of $181 million and additional consideration up to $329 million for achieving specific approval and sales milestones.

Specific to Ruconest, today the Company entered into a definitive agreement to divest all North American commercialization rights to Ruconest (recombinant human C1 esterase inhibitor) to Pharming Group N.V. ("Pharming"). Under the terms of the agreement, Pharming will pay Valeant aggregate consideration of up to $125 million, including an upfront fee of $60 million payable upon closing and certain sales-based milestone payments of up to $65 million. The transaction is subject to customary closing conditions, in addition to Pharming obtaining certain financing. Ruconest was classified as held for sale as of June 30, 2016 and an impairment loss of $199 million was recorded in the second quarter of 2016.

2016 Guidance
The Company is reconfirming its full year 2016 guidance. Total revenue is expected to be in the range of $9.9 – $10.1 billion. Adjusted EPS (non-GAAP) is expected to be in the range of $6.60 – $7.00. Adjusted EBITDA (non-GAAP) is expected to be in the range of $4.80 – $4.95 billion.

Other than with respect to total revenue, the Company only provides guidance on a non-GAAP basis. The Company does not provide reconciliations of forward-looking Adjusted EPS (non-GAAP) and Adjusted EBITDA (non-GAAP) to GAAP, due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliations. In periods where there are not expected to be significant acquisitions or divestitures, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, that would otherwise be treated as non-GAAP to calculate projected net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation settlements) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amounts of these deductions may be material and, therefore, could result in projected GAAP EPS and GAAP net income (loss) being materially less than projected Adjusted EPS (non-GAAP) and Adjusted EBITDA (non-GAAP).