On August 4, 2016 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, reported financial results for the second quarter of 2016 and provided a corporate update on its priorities for 2016 (Press release, Apricus Biosciences, AUG 4, 2016, View Source;p=RssLanding&cat=news&id=2193174 [SID:1234514249]).

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"In the second quarter, we sharpened our strategic focus in an effort to maximize the regulatory and commercial success of Vitaros with the goal of building a thriving and profitable global Vitaros brand," stated Richard W. Pascoe, Chief Executive Officer. "Our primary corporate goal continues to be the potential regulatory approval of Vitaros in the United States. In an effort to advance our Vitaros NDA resubmission, we requested, and we were recently granted, a Type B meeting with the FDA, scheduled for November 17, 2016. The purpose of this meeting is to confirm our strategy for addressing the deficiencies contained in the original 2008 Complete Response letter. We will incorporate any FDA feedback into the final submission, which we expect to occur as soon as possible after the meeting. We view the granting of this meeting as a favorable development and a reflection of our commitment to maintaining a constructive relationship with all regulatory authorities. Additionally, we have consolidated Vitaros territories in Europe and Asia with our newest partner Ferring in an effort to expand the global availability of Vitaros and increase revenue in important markets such as Germany. Moreover, we have substantially reduced our operating expenses and improved our balance sheet as part of our strategy to achieve profitability in 2017."

Second Quarter Highlights and Recent Developments

Apricus updated its corporate goals early in the second quarter 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. Second quarter and recent highlights include:

Expanded the Company’s exclusive Vitaros distribution agreement with Ferring International S.A. in Latin America to now include Germany, Austria, Belgium, Denmark, Finland, Iceland, Luxembourg, Norway, the Netherlands, Sweden, Switzerland and certain countries in Asia (previously Sandoz’s territories), the United Kingdom (previously Takeda’s territory) and Korea for up to an additional $3.85 million in upfront and pre-commercialization milestone payments and up to an additional $1.5 million in launch milestone payments, plus royalties on future net sales;
Closed on a common stock purchase agreement with Aspire Capital. Aspire Capital completed an initial purchase of 2,531,645 shares of common stock for proceeds of $1.0 million and has committed to purchase up to $6.0 million in additional shares of common stock over the next 24 months. No warrants were associated with this agreement;
Announced receipt of regulatory approval of Vitaros in Lebanon by our partner in the Middle East, Elis Pharmaceuticals, marking an important entry into a highly attractive Middle Eastern erectile dysfunction market; and
Obtained regulatory approval in Europe for an improved delivery device material of construction for the refrigerated version of Vitaros.
Strategic Priorities

Apricus continues to focus 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 targeted for the fourth quarter of 2016 and an approval decision expected after a six month review period;
Continue to support the Company’s ex-U.S. partners’ efforts to build a global brand and increase revenue by supporting new commercial launches by the Company’s partners and assisting 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)

Explore Orphan Drug Designation in the U.S. and EU; and
Explore global or regional partnerships prior to initiating the Phase 2b study.
Corporate/Financial

Reduce operating expenses by approximately 30% in 2016 and 60% in 2017 as compared to 2015 operating expenses; and
Grow Vitaros revenue, seek non-dilutive capital, and utilize lower cost of capital financial instruments to fund operations with the goal of achieving profitability in 2017.
Second Quarter Financial Results

Revenue for each of the quarters ended June 30, 2016 and 2015 was $0.5 million. Revenue during the quarter ended June 30, 2016 was comprised of $0.3 million in royalty revenues, an increase of $0.2 million or 305.3% over the quarter ended June 30, 2015. Revenue during the quarter ended June 30, 2015 included $0.4 million in product sales, the decline of which in 2016 was a result of our commercialization partners working directly with our manufacturers. Net loss for the quarter ended June 30, 2016 was $3.3 million, or loss per share of $0.05, compared to a net loss of $5.2 million, or $0.10 per share for the second quarter of 2015. Reducing the net loss for the quarter ended June 30, 2016 was a non-cash change in the fair value of the Company’s warrant liability in the amount of $1.6 million.

As of June 30, 2016, cash and cash equivalents totaled $2.7 million, compared to $3.9 million as of December 31, 2015. Cash and cash equivalents at June 30, 2016 do not reflect the receipt of $2.0 million in upfront payments received in July related to the Ferring Northern Europe and Asia territory expansion, nor any proceeds from sales of common stock to Aspire Capital.

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 Japan and China. 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 August 4, 2016 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) reported its financial results for the second quarter ended June 30, 2016 (Press release, Momenta Pharmaceuticals, AUG 4, 2016, View Source [SID:1234514248]).

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For the second quarter of 2016, the Company reported total revenues of $26.4 million, including $20.7 million in product revenues from Sandoz’s sale of Glatopa (glatiramer acetate injection). Momenta reported a net loss of $(21.0) million, or $(0.31) per share for the second quarter compared to a net loss of $(2.2) million, or $(0.04) per share for the same period in 2015. At June 30, 2016, the Company had cash, cash equivalents, and marketable securities of $336.9 million compared to $362.8 million at March 31, 2016.

"We are pleased with the growth in product revenues from Glatopa this quarter and look forward to the potential launch of our Glatopa 40 mg product next year," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "During the remainder of 2016 we plan to announce several key milestones including announcing top-line data from a pivotal trial for M923, a biosimilar candidate of HUMIRA developed in collaboration with Baxalta, the initiation of a clinical trial for M834, a biosimilar candidate of ORENCIA being developed in collaboration with Mylan, and completing enrollment of the single ascending dose portion of our Phase 1 trial for M281, a novel anti-FcRn antibody candidate."

Second Quarter Highlights and Recent Events

Complex Generics:

In the second quarter of 2016, Momenta recorded $20.7 million in product revenues from Sandoz’s Glatopa sales.
The ANDA submitted by Sandoz for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection) is under FDA review. The Company expects to receive tentative regulatory approval in 2016.
A district court trial challenging four of Teva’s five Orange Book-listed patents for COPAXONE 40 mg (glatiramer acetate injection) is scheduled for September 26, 2016.
Biosimilars:

In April 2016, Momenta and its collaboration partner Baxalta, now a part of Shire, completed enrollment in the pivotal clinical trial for M923, a biosimilar candidate of HUMIRA (adalimumab) and the companies expect to release results in late 2016. The companies are targeting first regulatory submission for marketing approval in 2017 and a first commercial launch as early as 2018.
Momenta’s global collaboration with Mylan to develop, manufacture and commercialize six of the Company’s biosimilar candidates is progressing. The companies have prioritized three lead programs including M834, a biosimilar candidate of ORENCIA (abatacept).
Novel Drugs:

Necuparanib (novel oncology candidate)

On August 3, 2016, the Data Safety Management Board recommended that the Company discontinue further accrual in the Phase 2 trial of necuparanib in pancreatic cancer following the outcome of a planned interim futility analysis. The Company plans to confirm the futility analysis and then determine next steps for the necuparanib program.
Autoimmune Drugs
Momenta’s novel autoimmune portfolio includes two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. In June 2016, the Company initiated a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy subjects. M230 is in pre-clinical development, and the Company expects to initiate a clinical trial for M230 in 2017. Momenta is also developing hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg. The Company continues its efforts to identify potential collaboration opportunities for the further development and commercialization of its hsIVIg program.

Second Quarter 2016 Financial Results

Total revenues for the second quarter of 2016 were $26.4 million compared to $44.9 million for the same period in 2015. Total revenues for the second quarter of 2016 include $20.7 million in product revenue earned from net sales of Glatopa by Sandoz, compared to $19.2 million in product revenue earned from net sales of Glatopa by Sandoz for the same period in 2015. Glatopa was launched in the second quarter of 2015, and Glatopa profit share for that quarter was reduced by $9.0 million to reimburse Sandoz for the Company’s share of pre-launch Glatopa-related legal expenses.

Collaborative research and development revenue for the second quarter of 2016 was $5.7 million compared to the $25.6 million recorded in the same quarter last year. In the second quarter of 2015, the Company earned $20.0 million in milestone payments under the Sandoz collaboration upon receiving sole FDA approval and upon the first commercial sale of Glatopa.

Research and development expenses for the second quarter of 2016 were $33.2 million, compared to $34.0 million for the same period in 2015. The decrease of $0.8 million, or 2%, from the 2015 period to the 2016 period was due to decreases of $0.8 million in stock-based compensation expense and $8.4 million for Mylan’s 50% share of biosimilar collaboration costs, which was offset by increases of $4.4 million in process and clinical development costs for M281 and biosimilars under the Company’s collaboration with Mylan, $2.2 million in non-clinical expenses to advance the Company’s novel autoimmune programs, $1.0 million in personnel-related expenses and $0.7 million in necuparanib Phase 2 clinical trial costs.

General and administrative expenses for the quarter ended June 30, 2016 were $14.9 million, compared with $13.3 million for the same period in 2015. The increase of $1.6 million, or 12%, was primarily due to an increase of $2.1 million in legal and professional fees. This increase was offset by a decrease of $0.5 million for Mylan’s 50% share of biosimilar collaboration costs.

At June 30, 2016, Momenta had $336.9 million in cash, cash equivalents and marketable securities.

Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Today, Momenta reiterated its non-GAAP operating expense guidance of approximately $40 – $45 million per quarter for the second half of 2016. Non-GAAP operating expense is total operating expenses (which is net of Mylan’s share of collaboration expenses), excluding stock-based compensation expense and net of collaborative reimbursement revenues from Sandoz and Baxalta. The quarterly recognition of collaborative revenues under the Company’s collaborations with Baxalta and Mylan is expected to be $2.4 million and $1.8 million per quarter, respectively.

On August 4, 2016 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three and six months ended June 30, 2016, and provided an operating forecast and program updates (Press release, Ligand, AUG 4, 2016, View Source [SID:1234514247]). Ligand management will host a conference call today beginning at 9:00 a.m. Eastern time to discuss this announcement and answer questions.

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"The past few months have been very active and rewarding with excellent revenue reports from our key licensees and important clinical, regulatory and commercial accomplishments by our partners," said John Higgins, Chief Executive Officer of Ligand. "Royalties are up nearly 50% over a year ago, driven by significant increases for Promacta and Kyprolis. One of our licensed products with the highest royalty rate is EVOMELA, and we are pleased to see its approval and commercial launch over the past few months. The OmniAb platform technology we acquired early this year continues to be validated with new and expanded licensing agreements, and adds considerable value in addition to our growing roster of Captisol-enabled programs. We now have more than 150 shots-on-goal, or fully funded programs partnered or licensed with other companies."

Second Quarter 2016 Financial Results

Total revenues for the second quarter of 2016 were $19.5 million, compared with $18.4 million for the same period in 2015. Royalty revenues were $9.8 million, compared with $6.6 million for the same period in 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $3.9 million, compared with $10.7 million for the same period in 2015 due to timing of Captisol purchases for use in clinical trials and commercial products. License and milestone revenues were $5.9 million, compared with $1.1 million for the same period in 2015 due primarily to the timing of milestones and upfront license fees.

Cost of goods sold was $0.7 million for the second quarter of 2016, compared with $2.6 million for the same period in 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $2.7 million, compared with $0.6 million for the same period in 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $4.5 million, compared with $3.4 million for the same period of 2015 as a result of timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $6.9 million, compared with $7.2 million for the same period in 2015.

GAAP net loss for the second quarter of 2016 was $5.8 million, or $0.28 per share, compared with GAAP net income for the same period of 2015 of $23.6 million, or $1.11 per diluted share. GAAP net loss includes a $10 million non-cash write-down in the value of the Company’s equity holdings of Viking, or $0.48 per share due to its ownership in Viking being reduced from 49% to 33% as a result of Viking’s financing completed during the second quarter. Currently, the Company records the value of Viking shares using the Equity Method, which requires the Company to estimate the dilution to its position upon Viking issuing new shares to third-parties. Adjusted net income for the second quarter of 2016 was $10.8 million, or $0.50 per diluted share, compared with adjusted net income for the same period in 2015 of $38.5 million, or $1.85 per diluted share.

As of June 30, 2016, Ligand had cash, cash equivalents and short-term investments of $107.0 million.

Year-to-Date Financial Results

Total revenues for the six months ended June 30, 2016 were $49.2 million, compared with $33.0 million for the same period in 2015. Royalty revenues were $24.1 million, compared with $16.9 million for the same period in 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $9.2 million, compared with $14.4 million for the same period in 2015 due to timing of Captisol purchases for use in clinical trials and commercial products. License and milestone revenues were $15.8 million, compared with $1.7 million for the same period in 2015 due primarily to the timing of milestones and upfront license fees.

Cost of goods sold was $1.7 million for the six months ended June 30, 2016, compared with $3.7 million for the same period in 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $5.2 million, compared with $1.2 million for the same period in 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $8.5 million, compared with $6.8 million for the same period of 2015 as a result of timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $13.7 million, compared with $13.2 million for the same period in 2015 due to costs associated with OmniAb and non-cash stock-based compensation expense.

GAAP net income for the six months ended June 30, 2016 was $0.8 million, or $0.04 per diluted share, compared with GAAP net income for the same period of 2015 of $24.3 million, or $1.16 per diluted share. GAAP net income includes a $10 million non-cash write-down in the value of the Company’s equity holdings of Viking, or $0.44 per share due to its ownership in Viking being reduced as a result of Viking’s financing completed during the second quarter. Adjusted net income for the six months ended June 30, 2016 was $31.8 million, or $1.47 per diluted share, compared with adjusted net income for the same period in 2015 of $45.4 million, or $2.19 per diluted share.

Financial Forecast

The Company affirms expectations for full-year 2016 total revenues to be between $115 million and $119 million, and adjusted earnings per diluted share to be between $3.41 and $3.46. Second half total revenues are projected to be in the range of $66 million to $70 million, and adjusted earnings per share are projected to be in the range of $1.94 to $1.99.

The adjusted earnings per diluted share guidance excludes non-cash stock-based compensation expense, non-cash debt-related costs, amortization related to acquisitions, changes in contingent liabilities, non-cash net losses of Viking Therapeutics equity, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, non-cash tax benefit (expense), unissued shares related to the anti-dilutive effect of second quarter 2016 GAAP net loss, unissued shares relating to the Senior Convertible Note and adjustments for discontinued operations, net of non-cash tax expense.

Second Quarter 2016 and Recent Business Highlights

Portfolio Program Progress

Promacta/Revolade

Novartis announced Q2 2016 net sales of Promacta (eltrombopag) of $158 million, a $27 million or 21% increase over Q1 2016. This is the largest quarter-over-quarter increase in net sales and comes one year after Novartis’s acquisition of the product from GSK in early 2015.
The European Commission approved Revolade (eltrombopag), a Novartis product, for the treatment of pediatric (age 1 and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins). The approval includes the use of tablets as well as a new oral suspension formulation of Revolade, which is designed for younger children who may not be able to swallow tablets.
Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On July 3, 2016, Amgen announced that the European Commission approved an expanded indication for Kyprolis (carfilzomib), to be used in combination with dexamethasone alone, for adult patients with multiple myeloma who have received at least one prior therapy.
On July 4, 2016, Ono Pharmaceuticals, holder of Kyprolis (carfilzomib) marketing rights in Japan, announced approval in Japan for treatment of patients with relapsed or refractory multiple myeloma.
On May 26, 2016, Amgen announced that the Kyprolis Global Economic Model (K-GEM) was published in the Journal of Medical Economics showing that in the United States, Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone is cost-effective compared with lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma and demonstrated an incremental cost-effectiveness ratio of $107,250 per Quality-Adjusted Life Year.
Additional Pipeline and Partner Developments

Spectrum Pharmaceuticals announced that the FDA granted seven years of Orphan Drug Exclusivity for EVOMELA for use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma.
Coherus BioSciences announced data demonstrating the equivalence of its etanercept biosimilar (CHS-0214) to Enbrel (etanercept), the reference product, with respect to efficacy as measured by the primary endpoint, ACR20 at 24 weeks.
Sage Therapeutics presented data that expanded scientific, clinical and burden-of-illness data for SAGE-547 at the 68th American Academy of Neurology Annual Meeting. Data from the open-label Phase 1/2 trial of SAGE-547 in super-refractory status epilepticus (SRSE) demonstrated that the 77% key efficacy endpoint response rate was not related to age, gender, ethnicity, co-morbid medical condition or underlying antiepileptic or third-line agents. Additional data presented illustrated that SRSE has a high burden of illness with significant morbidity, lengthy hospitalizations and significant utilization of ICU and overall hospital resources.
Oncobiologics announced that its Phase 3 clinical plan for ONS-3010 (Humira biosimilar) received the first of its European Union clinical trial authorization approvals, including in the United Kingdom, Germany and Spain, for the biosimilarity study portion of the Phase 3 clinical program.
Viking Therapeutics highlighted positive data from a Phase 1b trial of VK2809 (TR Beta) in subjects with mild hypercholesterolemia at the 65th Annual Scientific Session and Expo of the American College of Cardiology.
Viking Therapeutics announced positive top-line results from a proof-of-concept study of VK0214 in a mouse model of X-linked adrenoleukodystrophy (X-ALD), showing that VK0214 rapidly reduced plasma very long chain fatty acid levels by more than 25% in treated animals compared with vehicle controls (p < 0.01).
Merrimack Pharmaceuticals announced that the FDA granted seribantumab (MM-121) Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy.
Merrimack Pharmaceuticals announced initiation of a Phase 1 study of MM-151 in combination with ONIVYDE plus fluorouracil (5-FU) and Leucovorin in patients with RAS wild-type metastatic colorectal cancer, as well as the initiation of a biomarker-selected, multi-arm Phase 1 study for MM-151/MM-121 in metastatic colorectal, NSCLC and head and neck cancer that uses a combination of genetic and nongenetic biomarkers to match patients to appropriate novel combinations of investigational drug regimens based on their cancer’s molecular signature.
Millennium/Takeda highlighted Phase 1b data on pevonedistat + chemotherapy at the 2016 ASCO (Free ASCO Whitepaper) meeting.
Opthea announced that the Phase 1 dose-escalation study of OPT-302 met its primary objective demonstrating safety and tolerability as monotherapy and in combination with the current wet AMD standard of care Lucentis. Opthea is currently recruiting patients for its Phase 2a dose-expansion trial and expects data by the end of 2016.
Upsher-Smith announced that it commenced the first clinical study of its CXCR4 antagonist USL311 in patients with advanced solid tumors, triggering a $500,000 milestone payment to Ligand.
Marinus Pharmaceuticals announced that the FDA granted Orphan Drug designation to ganaxalone IV for the treatment of status epilepticus and that the company dosed the first subject in its Phase 1 clinical trial for the program.
An OmniAb licensee broadened its access to the platform by adding OmniFlic. Prior to the option exercise, this licensee’s access to the OmniAb technology was limited to OmniRat.
Wuxi out-licensed China rights to an undisclosed IND-ready antibody it discovered with the OmniAb platform and its sub-licensee will be responsible for all future costs related to the program.
Eli Lilly added a drug candidate to its Captisol platform license and supply agreement, first entered into in December of 2011.
New Licensing Deals

Ligand announced a license agreement for its LTP technology with Nucorion Pharmaceuticals, a venture-funded biotechnology company focused on developing anti-cancer and anti-viral agents initially directed to China, of which Ligand is a minority shareholder. Three initial programs fall under the license: NUC-202, a targeted anti-cancer analog for the treatment of hepatocellular carcinoma; NUC-404, a targeted nucleotide analog for the treatment of hepatitis B; and NUC-101, a targeted nucleotide analog for the treatment of hepatitis C. Ligand is eligible to receive milestones in addition to royalties ranging from 5% to 9% on future net sales of any approved program.
Ligand announced a worldwide license agreement with Gilead Sciences that allows Gilead to use the OmniAb platform to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under the license.
Ligand entered a worldwide license agreement with F-Star Biotechnology Limited that allows F-Star to use the OmniAb platform to discover fully human mono- and bispecific antibodies. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under the license.
Internal Glucagon Receptor Antagonist (GRA) Program

Ligand scientists gave an oral presentation on GRA at ENDO 2016 and presented a poster at the Levine-Riggs Diabetes Research Symposium, which highlighted data from the Phase 1b trial demonstrating that GRA significantly reduced fasting and post-prandial glucose in subjects with type 2 diabetes. Ligand expects to initiate a Phase 2 trial for the program in Q3 2016.
Recent Acquisitions

In May 2016, Ligand acquired economic rights to multiple programs owned by CorMatrix. Ligand paid $17.5 million to receive a portion of revenue from CorMatrix’s existing marketed products and will have the right to receive future royalties from potential future products.
Adjusted Financial Measures

The adjusted financial measures discussed above and in the tables below for the three and six months ended June 30, 2016 and 2015 exclude non-cash stock-based compensation expense, non-cash debt-related costs, amortization related to acquisitions, changes in contingent liabilities, non-cash net losses of Viking Therapeutics equity, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, non-cash tax benefit (expense), unissued shares related to the anti-dilutive effect of second quarter 2016 GAAP net loss, unissued shares relating to the Senior Convertible Note and adjustments for discontinued operations, net of non-cash tax expense.

Management has presented net income, net income per share in accordance with GAAP and on an adjusted basis. Ligand believes the presentation of adjusted financial measures provides useful supplementary information to investors and reflects amounts that are more closely aligned with the cash profits for the period. Ligand uses these adjusted financial measures in connection with its own budgeting and financial planning. These adjusted financial measures are in addition to, and not a substitute for, or superior to, measures of financial performance prepared in conformity with GAAP.

On August 4, 2016 Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) ("Juniper" or the "Company"), a women’s health therapeutics company, reported financial and other results for the three-month period ended June 30, 2016 (Press release, Juniper Pharmaceuticals, AUG 4, 2016, View Source;p=RssLanding&cat=news&id=2193006 [SID:1234514246]). Recent highlights include:

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· Product and service revenue increased 15% and 24%, respectively, versus the second quarter of 2015;

· Balance sheet remains strong;

Crinone (progesterone gel) approved in Japan under the brand OneCrinone;
· Completed enrollment of Phase 2b trial of COL-1077 10% lidocaine vaginal gel in women undergoing a minimally invasive pipelle-directed endometrial biopsy;

· Two Phase 1 studies of COL-1077 published in the international peer-reviewed medical journal Clinical Pharmacology in Drug Development;

· Phase 1 proof-of-concept study demonstrating the ability of Juniper’s intravaginal ring to successfully deliver the nine amino acid peptide leuprolide published in the influential peer-reviewed Journal of Controlled Release; and,

· Alicia Secor appointed President and CEO, and a director of the Company.

"I am very excited to join the Company, and congratulate the team on a strong second quarter," said Alicia Secor, Juniper’s President and CEO. "I look forward to building on this momentum as we work to transform Juniper into a leading, global, women’s health company."

"Strong growth of the ex-U.S. Crinone franchise and Juniper Pharma Services drove revenue up 16% to $11.9 million for the second quarter of 2016 versus the same period last year," said George O. Elston, Juniper’s Chief Financial Officer. "This solid year-to-date performance has enabled us to maintain a stable, healthy cash position while advancing our proprietary R&D programs."

"We are uniquely positioned to leverage our world-class service and platform capabilities to develop and commercialize important new therapeutics for women," Ms. Secor continued. "I look forward to advancing our current product candidates and expanding our portfolio to fulfill our mission to deliver value-added treatments that meet the unique and underserved healthcare needs of women."

The Company continues to expect to report top-line results of its recently-completed Phase 2b clinical trial of COL-1077 10% lidocaine bioadhesive vaginal gel this quarter and, assuming positive outcomes, to advance this candidate into Phase 3 in 2017.

If successful, COL-1077 is expected to fill an unmet need for pain management in women undergoing minimally-invasive gynecologic procedures. There are over seven million such procedures performed annually in the United States, with no standard of care for pre-treatment analgesia.

Juniper’s intravaginal ring ("IVR") programs continue to advance toward clinical development. The most advanced IVR product candidate is JNP-0101, an oxybutynin IVR for the treatment of overactive bladder in women. IND-enabling studies are underway including a study, defined in the Company’s pre-IND meeting with the FDA, to evaluate the pharmacokinetics of JNP-0101 in a representative animal model.

The Company is accelerating the Chemistry Manufacturing and Controls ("CMC") and production scale-up for JNP-0101 beyond its existing in-house capacity to further develop the go-to-market formulation and commercial manufacturing process ahead of its IND filing, which is now expected in 2017. This activity is intended to reduce CMC-related risks as JNP-0101 moves through clinical trials and toward commercialization in the $1.3 billion U.S. overactive bladder market.

Second Quarter Financial Results

Second quarter total revenues increased 16% to $11.9 million, compared with $10.2 million for the quarter ended June 30, 2015.

Product revenues were $7.6 million, an increase of $1.0 million, or 15%, versus the second quarter of last year, driven by continued in-market growth and new market sales of Crinone (progesterone gel) by Merck KGaA, Darmstadt, Germany.

Service revenues from Juniper Pharma Services were $3.4 million, an increase of $0.7 million, or 24%, versus the second quarter of last year, as we experienced continued strong growth in customer volume. Royalty revenues, based on Allergan’s sales of Crinone, were essentially unchanged at $0.9 million.

Gross profit increased to $5.4 million as compared with $4.6 million in the prior year quarter.

Total operating expenses were $7.2 million in the second quarter of 2016, a $2.2 million increase as compared to the prior year quarter.

Sales and marketing costs increased $0.1 million to $0.4 million in the second quarter of 2016, reflecting continued investment in the U.S. market by Juniper Pharma Services.

The $1.4 million increase in R&D spending as compared to the prior year quarter was predominantly driven by costs associated with the Phase 2b clinical trial of COL-1077. R&D expense also includes preclinical development costs for the IVR pipeline product candidates: JNP-0101 (oxybutynin IVR), JNP-0201 (estradiol + progesterone IVR for symptoms of menopause), and JNP-0301 (progesterone IVR for the prevention of preterm birth).

The $0.7 million increase in general and administrative costs as compared to the prior year quarter was primarily driven by the creation of an internal business development function that was not in place in 2015 along with costs associated with CEO succession and organizational growth.

Juniper recorded a net loss of $1.7 million, or $(0.16) per diluted share, in the second quarter of 2016, compared to a net loss of $0.3 million, or ($0.03) per diluted share, in the same period of 2015.

Liquidity

Cash and cash equivalents were $13.0 million as of June 30, 2016, versus $13.5 million at March 31, 2016 and $13.9 million at December 31, 2015. The decrease in cash and cash equivalents was primarily the result of capital expenditures.

Outlook

Based on year-to date revenues and expectations for the second half of the year, Juniper now anticipates full-year 2016 revenue growth in the low- to mid-teen percentage range over 2015 results.

On August 4, 2016 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported financial results for the quarter ended June 30, 2016 (Press release, Insmed, AUG 4, 2016, View Source [SID:1234514245]).

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Business Update

Global phase 3 CONVERT study advancing on track. The company continues to expect patient enrollment in its phase 3 study of ARIKAYCE (liposomal amikacin for inhalation) to conclude in 2016. The study, which is known as CONVERT or INS-212, is evaluating ARIKAYCE in nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC). CONVERT is taking place in 18 countries and involves more than 145 sites. The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the ARIKAYCE plus multi-drug regimen arm compared to the multi-drug regimen without ARIKAYCE arm.
Data from phase 2 study of ARIKAYCE presented at the 1st World Bronchiectasis Conference. One-year follow-up data from the company’s phase 2 study of ARIKAYCE in patients with NTM lung disease were recently presented at the 1st World Bronchiectasis Conference in Hannover, Germany. The presentation was one of nine abstracts accepted for oral presentation.
Data from phase 1 clinical study of INS1009 to be presented at ERS 2016. Two abstracts have been accepted for presentation at the European Respiratory Society (ERS) International Congress taking place in London September 3-7. The posters are titled "Single dose pharmacokinetics of C16TR for Inhalation (INS1009) vs. treprostinil inhalation solution" and "Safety and pharmacokinetics study of a single ascending dose of C16TR for inhalation (INS1009)". The presentations will take place on Monday September 5. INS1009 is one of the company’s nebulized treprostinil prodrugs, which may offer a differentiated product profile with therapeutic potential in rare pulmonary disorders such as pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), pulmonary sarcoidosis, and severe refractory asthma.
US Patent strengthens global patent portfolio. The United States Patent and Trademark Office issued patent no. 9,402,845, which provides methods of treating pulmonary infections via inhalation administration of a formulation containing a liposomal quinolone antibiotic and free quinolone antibiotic, such as ciprofloxacin. For example, a method of treating a bronchiectasis patient for a Pseudomonas aeruginosa pulmonary infection with the formulation is provided. The patent complements ARIKAYCE’s global intellectual property estate and further solidifies Insmed’s position as an innovator of liposomal antibiotic technology for pulmonary disorders and infections.
"Our phase 3 CONVERT study is our top corporate priority and we anticipate concluding enrollment later this year," said Will Lewis, president and chief executive officer of Insmed. "Positive data from CONVERT are expected to support a broad global regulatory strategy and advance our goal of bringing ARIKAYCE to patients with NTM lung disease who are in great need of new therapeutic options."

Second Quarter Financial Results

For the second quarter of 2016, Insmed posted a net loss of $36.6 million, or $0.59 per share, compared with a net loss of $28.6 million, or $0.47 per share, for the second quarter of 2015.

Research and development expenses were $23.9 million for the second quarter of 2016, compared with $18.2 million for the second quarter of 2015. The increase was primarily due to the advancement of the company’s global phase 3 CONVERT study of ARIKAYCE in NTM lung disease.

General and administrative expenses for the second quarter of 2016 were $12.3 million, compared with $9.7 million for the second quarter of 2015. The increase was primarily related to pre-commercial activities, namely the buildout of the company’s infrastructure and NTM disease awareness activities, as well as an increase in headcount and related expenses.

Balance Sheet Highlights and Cash Guidance

"Observing the market changes from the beginning of the year, we are closely managing our operations resulting in cash operating expenses at the low end of our guidance for the first half of the year," said Andy Drechsler, chief financial officer of Insmed. "We continue to ensure that mission-critical priorities, such as the phase 3 CONVERT study and other key pre-commercial activities, are fully resourced. Given our solid cash position and disciplined approached to capital allocation, we expect to execute on our operational and strategic priorities."

As of June 30, 2016, Insmed had cash and cash equivalents of $223 million. Excluding depreciation and stock-based compensation expense, the company’s cash operating expenses for the six months ended June 30, 2016 were $59 million, which was at the low end of the company’s previously guided range of $58 to $68 million. Insmed ended the second quarter of 2016 with $25 million in debt and $197 million of working capital.

The company is investing in the following activities in 2016: (i) clinical development of ARIKAYCE, (ii) regulatory and pre-commercial initiatives for ARIKAYCE, and (iii) preclinical and clinical activities for its earlier-stage pipeline. Insmed expects its cash-based operating expenses for the second half of 2016 to be in the range of $62 to $72 million.