On November 4, 2016 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the third quarter ended September 30, 2016 (Press release, Cambrex, NOV 4, 2016, View Source [SID1234516262]).

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Highlights

Sales increased 8% to $99.9 million compared to $92.4 million in the same quarter last year.
GAAP Diluted EPS from continuing operations was $0.42 compared to $0.36 in the same quarter last year and Adjusted Diluted EPS was $0.47 compared to $0.40 in the same quarter last year, representing 17% and 18% increases, respectively.
Operating Profit increased 8% to $19.5 million compared to $18.0 million and Adjusted EBITDA increased 11% to $26.3 million compared to $23.7 million in the same quarter last year (see table at the end of this release).
Net cash was $90.7 million at the end of the third quarter, an increase of $38.3 million during the quarter.
In October, the Company acquired PharmaCore Inc., a privately-owned North Carolina based company specializing in developing, manufacturing and scaling up small molecule APIs for clinical phase projects, for approximately $25 million.
The Company increased its financial guidance for full year sales and Adjusted EBITDA. The Company expects full year 2016 sales, excluding the impact of foreign currency, to increase between 12% and 14% compared to 2015. The Company expects Adjusted EBITDA to be between $147 and $151 million, a 14% to 17% increase compared to 2015 (see Financial Expectations – Continuing Operations section below).
"Based on our excellent year to date results, expectations for a strong fourth quarter and the addition of PharmaCore, renamed Cambrex High Point, we are increasing our sales and profit guidance for 2016," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"During the third quarter, we made announcements regarding investments at each of our three main manufacturing facilities. We are expanding our large scale, multi-purpose manufacturing capabilities at our Karlskoga, Sweden facility, we validated a newly opened pilot plant at our Milan, Italy location and early in the quarter we began production at our new large scale manufacturing facility within our Charles City, Iowa site. We believe these investments, among others, position us for continued growth and we continue to evaluate additional investments to ensure we have the capacity and flexibility to match our customers’ needs. We are also excited about our acquisition of PharmaCore, which adds world class capabilities to complete early phase clinical projects, expands our customer base and broadens our funnel for potential commercial projects when some of those therapeutics obtain regulatory approval."

Basis of Reporting

The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Third Quarter 2016 Operating Results – Continuing Operations

Sales were $99.9 million, compared to $92.4 million in the same period last year, an 8% increase. Foreign exchange had a negligible effect on sales. The sales increase primarily reflects higher volumes in our Innovator product category, partially offset by lower pricing and lower sales of generic APIs and controlled substances.

Gross margins decreased to 38% from 39% compared to the same quarter last year. The decrease was primarily due to lower pricing and unfavorable product mix. Foreign exchange had a negligible effect on gross margins.

Selling, general and administrative expenses were $15.0 million, compared to $14.0 million in the same quarter last year. The increase was mainly due to higher personnel costs and higher costs related to the recent acquisition of Cambrex High Point, partially offset by lower costs associated with the implementation of a new ERP system.

Research and development expenses were $3.2 million, compared to $3.7 million in the same quarter last year. The decrease was primarily related to timing of costs to develop new generic drug products.

Operating profit increased to $19.5 million from $18.0 million in the same quarter last year. The increase was primarily the result of higher gross profit, partially offset by higher operating expenses as described above. Adjusted EBITDA was $26.3 million compared to $23.7 million in the same quarter last year (see table at the end of this release).

Income tax expense was $5.4 million resulting in an effective tax rate of 28% compared to expense of $5.3 million and an effective tax rate of 31% in the same quarter last year. The decrease was primarily related to a small amount of tax benefits recorded this quarter.

Income from continuing operations was $13.7 million or $0.42 per share compared to $11.9 million or $0.36 per share in the same quarter last year. Adjusted income from continuing operations was $15.6 million or $0.47 per share, compared to $13.1 million or $0.40 per share in the same quarter last year (see table at the end of this release).

Capital expenditures and depreciation were $11.7 million and $6.2 million, respectively, compared to $14.5 million and $5.4 million, respectively, in the same quarter last year.

Net cash was $90.7 million at the end of the third quarter, an increase of $38.3 million during the quarter. The increase was primarily due to the timing of accounts receivable collections, partially offset by capital spending and increased inventory levels in anticipation of strong fourth quarter sales.

Financial Expectations – Continuing Operations

The following table shows the Company’s current expectations for its full year 2016 financial performance compared to its previous expectations:

Current
Expectations Previous
Expectations
Gross sales increase 12% – 14% 10% – 13%
Adjusted EBITDA $147 – $151 million $144 – $149 million
Adjusted income from continuing operations per share $2.67 – $2.75 $2.49 – $2.61
Free cash flow $65 – $75 million $60 – $70 million
Capital expenditures $67 – $72 million $70 – $75 million
Depreciation $24 – $25 million $25 – $27 million
Effective tax rate 31% – 33% 32% – 34%

Consistent with prior guidance for the full year 2016, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities, outcomes of tax disputes and any charges related to any future sale of the Company’s Zenara business located in Hyderabad, India. Current expectations include the acquisition of PharmaCore, which was completed in early October 2016. Sales expectations exclude the impact of foreign exchange. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2016 will be computed on a basis consistent with the reconciliation of the third quarter 2016 financial results in the tables at the end of this release. Free cash flow is the change in debt, net of cash during the year. The tax rate will be sensitive to the Company’s geographic mix of income.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s third quarter 2016 Form 10-Q is filed with the SEC.

On November 4, 2016 Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) reported a business update and reported financial results for the third quarter ended September 30, 2016 (Filing, Q3, Anthera, 2016, NOV 4, 2016, View Source [SID1234516255]).

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Recent Developments and Business Highlights:

Blisibimod for the treatment of Systemic Lupus Erythematosus ("SLE")

o Topline Data from Phase 3 CHABLIS-SC1 Clinical Study
We have been working diligently through the adjudication for the CHABLIS-SC-1 study, which completed the last patient visit in September. We currently plan to report topline efficacy and safety data prior to the 2016 American College of Rheumatology Annual Meeting taking place from November 11th to November 16th. Topline data from the CHABLIS-SC1 will include the primary endpoint evaluation, the Systemic Lupus Erythematosus Responder Index (SRI-6) as well as safety and tolerability data from the study. For more information on the CHABLIS-SC1 study, please visit View Source

o Phase 3 CHABLIS 7.5 Clinical Study Enrollment and Clinical Site Activation On Track
We continued further clinical site activation for, and enrollment in CHABLIS 7.5, our second Phase 3 clinical study. This study will evaluate the efficacy and safety of blisibimod in patients who, despite corticosteroid use, continue to have clinically-active lupus (SLE) and the presence of anti-double-stranded DNA and low complements which are known serological markers of lupus. For more information about the CHABLIS 7.5 study, visit View Source

Sollpura (liprotamase) for the treatment of Exocrine Pancreatic Insufficiency ("EPI")

o Phase 3 SOLUTION Clinical Study
Following the completion of patient enrollment in our Phase 3 SOLUTION study, an independent Data and Safety Monitoring Board (DSMB) recommended continuation of the study without modification on August 3, 2016. Subsequent assessment by the DSMB on September 25, 2016, found no concerning safety signals. We expect to report topline efficacy data from the SOLUTION study before the end of 2016. For more information on the SOLUTION clinical study, please visit View Source

o SIMPLICITY Clinical Study Enrollment on Track
Enrollment in the SIMPLICITY study, which intends to evaluate the efficacy and safety of Sollpura supplied as a powder for oral solution, is on track. In this study, Sollpura is delivered in a convenient, easy-to-administer single use package. We completed enrollment of the initial cohort of patients 7 years of age and above, and following a review of safety and efficacy data by an independent DSMB, the study will allow for administration of Sollpura powder for oral solution to pediatric patients ranging in age from 28 days to less than 7 years. For more information on the study, please visit View Source

o EASY Clinical Study
During the third quarter of 2016, we initiated the EASY study, which provides continued access to Sollpura for patients who completed the SOLUTION study. We plan to continue the EASY study until Biologic License Application ("BLA") for Sollpura is approved by the U.S. Food and Drug Administration ("FDA").

o Manufacturing to Support Commercial Readiness Accelerated
We began acceleration of the manufacturing scale-up to support the commercial launch of Sollpura including the completion of demonstration and registration batches at commercial launch scale. We had a Type-C meeting with the FDA in September to discuss the manufacturing approach for the Lipase-CLEC drug substance and the conversion of the filed Sollpura New Drug Application ("NDA") to a BLA. The FDA confirmed that Sollpura fits the regulatory definition of a biologic, supporting the conversion of the filed NDA to a BLA. Furthermore, preliminary agreement was reached on Anthera’s approach to demonstration of comparability of drug substance manufactured by a new contract manufacturing organization ("CMO"), and the potential use of a comparability protocol to manage post-approval process scale up.

Blisibimod for the treatment of IgA Nephropathy

o Longer-Term Evaluation Continues in Phase 2 BRIGHT-SC Clinical Study
In June 2016, an interim analysis of observed data from 57 patients, all of whom had the opportunity to complete 24 weeks of treatment, demonstrated a positive trend in lower proteinuria in blisibimod versus placebo treated patients over two years, supporting continuation of the study. Data from the 48-week evaluation is expected at the end of this year or in early first quarter of 2017. For more information about the BRIGHT-SC study, visit View Source

Management Update

· On August 16, 2016, we appointed William Shanahan, M.D., J.D. as Chief Medical Officer. In this role, Dr. Shanahan will oversee the clinical development of the blisibimod and Sollpura programs. Dr. Shanahan joins Anthera with over 30 years of drug development experience, including 16 years as a chief medical officer.

Summary of Financial Results

o Registered Direct Offering. In September 2016, we executed a subscription agreement with Biotechnology Value Fund, L.P. and other affiliates of BVF Partners L.P. ("BVF"), and Rock Springs Capital, pursuant to which we may sell convertible preferred stock in two tranches. The initial tranche closed on September 14 and we received gross proceeds of $17 million. The investors have an option for an additional $28.3 million of convertible preferred stock at their discretion. Each share of preferred stock is convertible into shares of common stock at various prices in the future. The initial $17 million of Series X convertible preferred stock received warrant coverage equal to 25% of the issued shares of common stock with an exercise price equal to 120% of the conversion price of the Series X convertible preferred stock.

o Cash Position. We ended the third quarter of 2016 with cash and cash equivalents totaling $32.6 million, compared to $47 million as of December 31, 2015. The decrease in cash was mainly attributable to $36.7 million used to fund our clinical development programs during the nine months ended September 30, 2016, offset by approximately $23 million in net proceeds received from the sale of common and preferred stock.

o R&D Expense. Research and development expenses for the three and nine months ended September 30, 2016 totaled $14.1 million and $35.7 million, respectively, compared to $10.4 million and $24.9 million for the corresponding periods in 2015. The increase is primarily due to cost associated with acceleration of the manufacturing scale-up timeline, including the production of demonstration and registration batches at commercial launch scale for Sollpura and the purchase and installation of manufacturing equipment at our contract manufacturers. Additionally, clinical development expense increased from prior year due to the initiation of three new clinical studies, namely the CHABLIS-7.5 study with blisibimod in severe lupus patients, the SIMPLICITY study with Sollpura in sachet formulation and the EASY study which provides continued access to Sollpura for patients who completed the SOLUTION study.

o G&A Expense. General and administrative expenses for the three and nine months ended September 30, 2016 totaled $2.5 million and $7.3 million, respectively, compared to $2.1 million and $5.7 million for the corresponding periods in 2015. The increase is primarily due to higher non-cash stock-based compensation expense recognized during the three and nine months ended September 30, 2016.

o Net Loss. Net loss for the three and nine months ended September 30, 2016 was $16.5 million and $42.5 million, respectively, compared to $11.3 million and $27.9 million for the corresponding periods in 2015. The increase in net loss is mainly attributable to the increase in manufacturing expense for Sollpura and clinical study expense for both Sollpura and blisibimod in 2016.

o Net Loss Applicable to Common Stockholders. In connection with the September 2016 registered direct offering of convertible preferred stock, warrants and option to purchase future shares of convertible preferred stock, there is an in-the-money conversion feature (beneficial conversion feature, or BCF) that required separate financial statement recognition and was recorded as a discount to the preferred shares and was immediately accreted as a deemed dividend because the shares are immediately convertible. For the quarter and nine months ended September 30, 2016, we recorded a deemed dividend of $8.8 million.

On November 4, 2016 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; "Sumitomo Dainippon Pharma") reported that clinical data of an investigational WT1 cancer peptide vaccine, DSP-7888 will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in San Diego from December 3 to 6, 2016 (Press release, Dainippon Sumitomo Pharma, NOV 4, 2016, View Source [SID1234516253]).

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Planned poster sessions include:
1. Abstract #4335, [637. Myelodysplastic Syndromes―Clinical Studies: Poster III]
Preliminary Results from a Phase 1/2 Study of DSP-7888, a Novel WT1 Peptide-Based Vaccine, in Patients with Myelodysplastic Syndrome (MDS)
Presenter: S. Miyakoshi (Department of Hematology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo, Japan)
Monday, December 5 from 6:00 p.m. – 8:00 p.m. (local time), Hall GH
The abstract is now available on the official website of ASH (Free ASH Whitepaper) (URL: View Source)
Highlights of the abstract】
In phase 1 portion, azacitidine (the first-line treatment option) failure higher-risk (7 patients) and transfusion-dependent lower-risk (5 patients) MDS patients (total 12 patients) were enrolled in 3.5 or 10.5 mg/body cohorts. Safety and tolerability were evaluated, and delayed type hypersensitivity (DTH), WT1-specific CTL induction and expression of WT1 mRNA in peripheral blood and bone marrow cells were also examined.

DSP-7888 was well-tolerated in MDS patients and dose-dependent toxicity was not observed except for ISR, although ISR was observed in all patients.

Disease control rate (PR+SD) was observed in 66.6 % and CTL induction, one of the secondary clinical activities, was observed in 50% of the 12 evaluable patients.

2. Abstract #4715, [802. Chemical Biology and Experimental Therapeutics: Poster III]
DSP-7888, a Novel Cocktail Design of WT1 Peptide Vaccine, and Its Combinational Immunotherapy with Immune Checkpoint-Blocking Antibody Against PD-1
Note:This data is non-clinical evaluation. 2
Presenter: M. Goto (DSP Cancer Institute, Sumitomo Dainippon Pharma Co., Ltd., Japan) Monday, December 5 from 6:00 p.m. – 8:00 p.m. (local time), Hall GH
The abstract is now available on the official website of ASH (Free ASH Whitepaper) (URL: View Source)

On November 4, 2016 Celsion Corporation (NASDAQ:CLSN), a clinical stage oncology drug development company, reported that the United States Patent and Trademark Office (USPTO) has granted two patents: Patent No. 9,468,687 B2 – Immuno Gene Therapy for Treatment of Cancer and Hyperproliferative Diseases, which expands the use of GEN-1 into additional cancer treatment modalities in combination with other chemotherapeutics and Patent No. 9,144,546 – Nucleic Acid-Lipopolymer Compositions, which expands and extends previous patent claims on the making of and composition of formulations consisting of our PPC delivery polymer and nucleic acids (Press release, Celsion, NOV 4, 2016, View Source [SID1234516252]).

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These new patents further strengthen coverage of GEN-1, the Company’s DNA-based immunotherapy in development for the localized treatment of ovarian cancer and glioblastoma multiforme (GBM), which is already covered by a composition of matter patent in the United States.

"Issuance of these patents further strengthens Celsion’s growing position as a leader in the development of gene-based immunotherapies addressing some of the most difficult-to-treat cancers, such as ovarian cancer and GBM by covering the use of GEN-1 for treating solid tumors as a monotherapy and in combination with chemotherapy," said Michael H. Tardugno, chairman, president and CEO. "GEN-1 leverages our proprietary TheraPlas technology platform, harnessing the power of IL-12 immunotherapy with a targeted delivery system engineered to overcome the limitations associated with the development of other dosage forms of IL-12 therapies."

About GEN-1
GEN-1 is being evaluated in an ongoing Phase 1b dose-escalating clinical trial (the "OVATION Study") combining GEN-1 with the standard of care for the treatment of newly diagnosed patients with advanced ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debunking surgery. The OVATION Study is designed to enroll three to six patients per dose cohort at escalating doses of GEN-1 with the goal to identify a safe, tolerable and therapeutically active dose of GEN-1 by recruiting and maximizing an antitumor immune response.

As previously reported, all six patients in the first two cohorts of the OVATION Study experienced a clinically meaningful response, ranging from stable disease to one pathologically confirmed complete response. In addition, all patients sustained decreases of 90% or greater of the prospective indicator of the presence of ovarian cancer cells, CA-125 protein as well as highly impressive pathologically responses, which is associated with prolonged survival. The first three cohorts each enrolled three patients. Enrollment in the fourth and final cohort is underway, and Celsion expects to report full data from the OVATION Study by the first quarter of 2017. Future studies of GEN-1 will include a Phase I/II study combining GEN-1 with Avastin and Doxil for the treatment of recurrent ovarian cancer.

On November 4, 2016 AVEO Oncology (NASDAQ:AVEO) reported financial results for the third quarter ended September 30, 2016 (Press release, AVEO, NOV 4, 2016, View Source;p=RssLanding&cat=news&id=2219710 [SID1234516250]).

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"In the last 18 months, we have made important progress in moving forward both elements of our strategy, including our oncology pipeline, for which we have retained significant North American rights, and our non-oncology pipeline, which is being advanced through partnerships with disease-area experts," said Michael Bailey, president and chief executive officer. "We anticipate a milestone rich calendar in the months ahead, spanning both our proprietary and partnered programs, that we expect will help define AVEO’s long-term potential in multiple areas of unmet medical need."

Mr. Bailey added: "For our lead oncology asset, tivozanib, we are well underway in three simultaneous paths. We expect an approval decision in first-line renal cell cancer (RCC) in Europe and initial results from the Opdivo combination TiNivo study in the first half of 2017, followed by, in the first quarter of 2018, pivotal top-line data from our U.S.-registration-directed Phase 3 TIVO-3 study in RCC. During 2017, we also expect to see progress in our partnered pipeline, serving to highlight the value-potential of these programs which are being developed at little or no cost to AVEO."

Potential Corporate Milestones through the First Half of 2017

Regulatory decision for tivozanib in the European Union and associated milestone payment by EUSA Pharma;
IND and proof-of-concept milestone payments for tivozanib in acute macular degeneration by Ophthotech;
Partnership for AV-353, a first-in-class opportunity to address a major unmet need in pulmonary arterial hypertension;
Initial safety results from the Phase 1 portion of the Phase 1/2 AVEO-sponsored TiNivo study of tivozanib in combination with Bristol-Myers Squibb’s Opdivo (nivolumab);
Development progress and milestone payments for AV-380 in Cachexia by Novartis;
Manufacturing tech transfer milestone payment for AV-203 by CANbridge.
Third Quarter and Recent Highlights

Initiation of Phase 1/2 TiNivo Trial Evaluating Tivozanib in Combination with Bristol-Myers Squibb’s Opdivo (nivolumab) in Advanced RCC. In August 2016, AVEO announced the initiation of a Phase 1/2 clinical trial of AVEO’s oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), tivozanib, in combination with Bristol-Myers Squibb’s anti-PD-1 therapy, Opdivo (nivolumab), in advanced RCC, named the TiNivo Trial. The trial is being led by the Institut Gustave Roussy in Paris under the direction of Professor Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee. The Phase 1 trial is designed to evaluate whether tivozanib’s unique specificity and associated safety profile can overcome the tolerability issues that have challenged TKI-PD1 combinations to date. Initial safety results from the Phase 1 portion of the Phase 1/2 are expected to be available to the companies in the first half of 2017.
Ongoing Review of the Marketing Authorization Application (MAA) in Europe for Approval of Tivozanib as a First-Line RCC Treatment Option. EUSA Pharma, to which the Company licensed European and additional rights outside North America, is working to submit responses to the European Medicines Agency (EMA) Day 120 List of Questions before year-end. The MAA, which is based on tivozanib’s existing dataset, including the Phase 3 TIVO-1 study of tivozanib in first-line RCC, seeks approval for tivozanib as a first-line treatment for advanced RCC under the EMA’s centralized review process. Following the response, EUSA Pharma expects to receive the EMA Day 180 List of Outstanding Issues, the last review stopping period prior to a recommendation from the Committee for Medicinal Products for Human Use (CHMP) and the final approval decision from EMA. If approved, tivozanib’s distinct safety profile has the potential to offer a new, well tolerated alternative to currently approved VEGF TKIs, which, in clinical studies, have been associated with challenging tolerability necessitating significant dose reductions and interruptions.
Continued Execution of the Pivotal Phase 3 TIVO-3 Study of Tivozanib in RCC. In May 2016, AVEO announced the commencement of enrollment and patient treatment for the Company’s pivotal TIVO-3 trial, a randomized, controlled, multi-center, open-label study to compare tivozanib to sorafenib in subjects with refractory advanced RCC. The study continues to be on track to reach a top line readout in the first quarter of 2018. The Phase 3 trial is expected to enroll approximately 322 patients with recurrent or metastatic RCC who have failed at least two prior regimens, including VEGF-TKI therapy (other than sorafenib). Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients will be randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms.

The TIVO-3 trial, together with the TIVO-1 trial, is designed to support a first- and third-line indication for tivozanib in the U.S. TIVO-3 would also provide a unique data set, in that it is expected to include the first randomized Phase 3 results showing treatment with a VEGF TKI following prior PD1 therapy, and is designed to support approval of the first VEGF TKI specifically labeled for third-line treatment.
Third Quarter 2016 Financial Highlights

AVEO ended Q3 2016 with $30.8 million in cash, cash equivalents and marketable securities as compared with $34.1 million at December 31, 2015.
Total collaboration revenue in Q3 2016 was approximately $1.0 million compared with $15.2 million Q3 2015.
Research and development expense was $4.4 million in Q3 2016 compared with $4.5 million for Q3 2015.
General and administrative expense was $2.1 million in Q3 2016 compared with $2.2 million for Q3 2015.
Net loss for Q3 2016 was $5.0 million, or a loss of $0.07 per basic and diluted share, compared with net income of $7.9 million, or income of $0.14 per basic and diluted share for Q3 2015.
Financial Guidance

We believe that our $30.8 million in cash resources could allow us to fund our planned operations into the fourth quarter of 2017. Furthermore, we expect that these cash resources, together with certain anticipated operational milestone payments from our collaboration partners, could allow us to fund our U.S. tivozanib development strategy through at least pivotal Phase 3 TIVO-3 top-line data as well as our tivozanib-PD-1 inhibitor combination trial.