Anixa Biosciences to Present at Moffitt Cancer Center’s Business of Biotech Conference

On February 13, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that Dr. Amit Kumar, its President and CEO, will be presenting on a panel discussion at Moffitt Cancer Center’s 13th Annual Business of Biotech Conference being held on February 22, 2019 (Press release, Anixa Biosciences, FEB 13, 2019, View Source [SID1234533295]). The panel titled, "Navigating FDA Approvals for Cell Therapy" will focus on regulatory aspects of developing CAR-T and other cell therapies.

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In addition to Dr. Kumar, other participants on the panel will include executives from Atara Biotherapeutics, Inc., Intellia Therapeutics, Inc., and Iovance Biotherapeutics, Inc.

The Business of Biotech Conference is an annual event held by Moffitt Cancer Center that brings together investors and experts from academia and industry interested in learning about the most advanced technologies in cancer research. For those interested in attending, please review the agenda and register here: View Source

Dr. Kumar stated, "I am pleased to be attending and presenting at this conference. Moffitt Cancer Center is one of the top cancer centers in the world and a critical partner for Anixa. I am also pleased to be participating with colleagues from other leading CAR-T and cell therapy companies."

Perrigo Company plc To Release Fourth Quarter And Calendar Year 2018 Results On February 27, 2019

On February 13, 2019 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of "Quality, Affordable Self-care Products", reported that it will release its fourth quarter and calendar year 2018 financial results on Wednesday, February 27, 2019 (Press release, Perrigo Company, FEB 13, 2019, View Source [SID1234533279]). The Company will host a conference call beginning at 4:30 p.m. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 0121144. A taped replay of the call will be available beginning at approximately 7:00 p.m. (EST) Wednesday, February 27, 2019, until midnight March 6, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10128203.

Cambrex Reports Fourth Quarter and Full Year 2018 Financial Results

On February 13, 2019 Cambrex Corporation (NYSE: CBM), a leading provider of development, manufacturing, testing and technology services for small molecules, reported results for the fourth quarter and full year ended December 31, 2018 (Press release, Cambrex, FEB 13, 2019, View Source [SID1234533280]).

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Fourth Quarter 2018 Highlights

Announced the acquisition of Avista Pharma Solutions ("Avista"), an early clinical phase Contract Development, Manufacturing and Testing Organization, for approximately $252 million in total cash consideration. This transaction closed on January 2, 2019.
Net revenue was $134.3 million under current U.S. GAAP, ASC 606 ("ASC 606"). Under ASC 605, the previous revenue recognition standard, and the only standard under which fourth quarter 2017 results were reported, Net revenue increased 16% compared to the same quarter last year.
Under current U.S. GAAP, Income from continuing operations was $1.3 million and Diluted EPS was $0.04 per share. This reflects the impacts of the timing of certain tax charges related to tax reform in New Jersey. Under previous U.S. GAAP utilizing ASC 605, Income from continuing operations would have been $32.3 million and Diluted EPS from continuing operations would have been $0.96 per share compared to Income from continuing operations of $40.2 million and Diluted EPS of $1.20 in the same quarter last year. Adjusted Income from continuing operations was $48.7 million and Diluted EPS was $1.44, compared to $42.3 million and $1.26, respectively, for the same quarter last year (see table at the end of this press release).
Under ASC 606, EBITDA was $33.5 million. Adjusted EBITDA, which excludes the impact of adopting ASC 606, Halo’s results and Acquisition and Integration costs, was $70.7 million compared to $65.1 million in the same quarter last year (see table at the end of this press release).
Net debt was $204.1 million at the end of the quarter, a decrease of $23.7 million during the quarter primarily driven by cash flows from operations.
The Company expects full year 2019 Net revenue, which excludes the impact of foreign currency, to be between 21% and 25% higher than 2018 Net revenue as recorded under ASC 606 for both years. Adjusted EBITDA is expected to be between $150 and $160 million(see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"We’re very excited to add the early stage development and testing capabilities of Avista Pharma, which when added to the drug product capabilities of Halo Pharma, which we acquired a few months ago, and Cambrex’s legacy drug substance capabilities, makes us a leading global provider of end to end integrated services for small molecules. Combining Cambrex, Halo and Avista will allow us to follow a small molecule from pre-clinical through commercialization and leverage hundreds of new customers and molecule opportunities across a much broader services and manufacturing platform. Integration efforts are well under way with the goal of building a best-in-class fully integrated contract development and manufacturing organization," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"Looking forward, we continue to see strong market conditions in the sectors that we serve. This is especially true in early stage development and testing, where we expect continued strong growth, creating the potential for a large funnel of molecules for which we hope to deliver a broad range of services all the way through commercial approval."

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

Fourth Quarter 2018 Operating Results – Consolidated, Continuing Operations
Net revenue under ASC 606 was $134.3 million. Under ASC 605, the revenue recognition standard for which 2017 results were reported, Net revenue increased to $212.3 million, or 16%, from $182.3 million in the same quarter last year. Results under ASC 605 include a 2% unfavorable impact of foreign exchange compared to the fourth quarter of 2017. Net revenue during the fourth quarter of 2018 includes the acquisition of Halo, now our finished dosage form segment, which contributed revenue of $23.4 million under ASC 606 and $23.2 millionunder ASC 605. Excluding finished dosage form Net revenues, higher sales of controlled substances was the primary driver of the increase under ASC 605 compared to the same quarter last year.

Gross margin under ASC 606 was 36% for the fourth quarter of 2018. Under ASC 605, Gross margin was 41% compared to 43% in the same quarter last year. Excluding the finished dosage form segment and the unfavorable impact of foreign exchange, ASC 605 Gross margin during the quarter was 42%.

Selling, general and administrative expenses were $21.5 million, compared to $18.3 million in the same quarter last year. The increase was mainly due to higher amortization expense related to purchased intangible assets of $3.0 million within the finished dosage form segment.

Research and development expenses were $3.6 million, compared to $4.3 million in the same quarter last year. The decrease is primarily due to lower expenses related to the development of generic drug products.

Acquisition and Integration expenses of $3.4 million for the fourth quarter of 2018 represent costs associated with the acquisitions of Halo and Avista. The acquisition of Avista closed on January 2, 2019.

Operating profit under ASC 606 was $19.8 million for the fourth quarter of 2018. Under ASC 605, Operating profit was $58.8 millioncompared to $56.3 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 $70.7 million compared to $65.1 million in the same quarter last year (see table at the end of this press release).

Income tax expense under ASC 606 was $17.5 million resulting in an effective tax rate of 93% compared to $15.6 million and an effective tax rate of 28% in the same quarter last year. Income tax expense during the quarter reflects $11.4 million of expense primarily for a state valuation allowance due to New Jersey tax reform enacted during the fourth quarter of 2018. The fourth quarter of 2018 also includes the immediate recognition of certain effects of share-based compensation, acquisition and integration expenses, amortization of purchased intangibles, unrealized gain on investment in equity securities and the finalization of the U.S. tax reform toll charge on undistributed foreign earnings. Under ASC 605 and excluding these items, the effective tax rate would have been approximately 22% during the quarter.

Income from continuing operations under ASC 606 was $1.3 million. Under ASC 605, Income from continuing operations was $32.3 million, or $0.96 per diluted share, compared to $40.2 million, or $1.20 per diluted share, in the same quarter last year.

Adjusted Income from continuing operations, calculated under ASC 605, to be comparable to the prior year results, and including other adjustments described in the table at the end of this press release, was $48.7 million or $1.44 per share, compared to $42.3 million or $1.26per share in the same quarter last year.

Capital expenditures were $19.1 million and depreciation and amortization was $13.7 million compared to $13.9 million and $8.8 million, respectively, in the same quarter last year.

Net debt was $204.1 million at the end of the quarter, a decrease of $23.7 million during the quarter primarily driven by cash flows from operations.

As a result of the Halo acquisition in September 2018, and to be in alignment with how the business is managed, the Company’s operating segments were aggregated to form two reportable segments, Active Pharmaceutical Ingredients ("APIs") and Finished Dosage Form ("FDF"). The API segment consists of four operating segments which manufactures APIs. The FDF segment consists of one operating segment which manufactures and develops finished dosage form products.

Fourth Quarter 2018 Operating Results – Active Pharmaceutical Ingredients ("API") segment
Net revenue was $110.9 million under ASC 606. Under ASC 605, net revenue was $189.1 million compared to $182.3 in the same quarter last year, a 3.7% increase. Results under ASC 605 include a 2% unfavorable impact of foreign exchange compared to the fourth quarter of 2017. Higher sales of controlled substances was the primary driver of the increase under ASC 605 compared to the same quarter last year.

Gross profit in the fourth quarter of 2018 was $42.6 million. Under ASC 605, Gross profit would have been $81.8 million compared to $78.9 million in the same quarter last year. Gross margins decreased to 38% from 43% in the same quarter last year. Excluding the impact of the new revenue recognition standard, gross margins would have been 43%.

Selling, general and administrative ("SG&A") expenses were $10.2 million in the fourth quarter 2018, compared to $14.0 million in the same quarter last year. The decrease was mainly due to lower personnel related costs and consulting expenses.

Operating profit was $29.3 million under ASC 606 in the fourth quarter 2018. Under ASC 605, operating profit was $68.6 million compared to $61.9 in the fourth quarter 2017. The increase in operating profit under ASC 605 was due to higher gross profit and lower operating expenses.

Fourth Quarter 2018 Operating Results – Finished Dosage Form ("FDF") segment
Results on an ASC 605 basis were not materially different than the reported results under ASC 606.

FDF Net revenue in the fourth quarter of 2018 was $23.4 million under ASC 606.

Gross profit was $5.7 million and gross margin was 24% under ASC 606 in the fourth quarter of 2018.

Selling, general and administrative expenses were $5.4 million in the fourth quarter of 2018 including amortization of purchased intangibles of $3.0 million.

Acquisition and Integration expenses of $1.1 million for the fourth quarter of 2018 represent costs associated with the acquisitions of Halo and Avista.

Operating loss under ASC 606 was $0.7 million. Operating loss includes $1.1 million in integration costs and approximately $3.3 million of increased depreciation and amortization expense resulting from the application of purchase accounting.

Fourth Quarter 2018 Operating Results – Corporate Headquarters
Selling, general and administrative expenses were $5.9 million in the fourth quarter of 2018 compared to $4.3 million in the same quarter last year. The increase is primarily related to higher personnel related expenses.

Acquisition and Integration expenses of $2.3 million for the fourth quarter of 2018 represent costs associated with the acquisitions of Halo and Avista.

Operating loss in the fourth quarter 2018 was $8.8 million compared to $5.6 million in the same quarter last year.

Financial Expectations – Continuing Operations
The following table shows the Company’s current expectations for its full year 2019 financial performance. The expectations in the table below reflect expected results from the business including the recent acquisitions of Halo and Avista. All expectations for 2019, including growth relative to 2018, are based on actual and expected ASC 606 results for both years.

Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential future acquisitions and related transaction and integration expenses, including those related to the recent acquisitions of Halo Pharma and Avista Pharma Solutions, divestitures, restructuring activities, certain tax items discussed below, and the impact of foreign currency on Net revenue.

EBITDA, Adjusted EBITDA and Adjusted Income from continuing operations per share for 2019 will be computed on a basis consistent with the reconciliation of the current quarter financial results in the tables at the end of this press release, except that all 2019 results will be on an ASC 606 basis. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes the immediate recognition of certain benefits of share-based compensation and certain other items adjusted for in the non-GAAP reconciliation tables at the end of this release.

The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax laws or rates within the countries in which the Company operates and the effects of certain share-based payments. Reconciliations of these measures to measures calculated in accordance with GAAP are not available without unreasonable effort due to the unavailability of certain information needed to calculate certain reconciling items, including interest expense and income tax expense.

We expect M&A and related integration expenses for 2019 to be between $9 and $11 million. These amounts are excluded from our consolidated Adjusted EBITDA and Adjusted income from continuing operations per share guidance included above. These expenses consist of approximately $4.5 million of transaction expenses paid in conjunction with our acquisition of Avista in early January and the remainder will consist of integration expenses incurred across most functional areas throughout 2019. This estimate also includes certain immediate and one-time expenses related to IT systems, but does not include costs to upgrade the two newly acquired businesses to SAP, our ERP software, which will likely happen over the course of 2019 and 2020.

Expectations above include preliminary estimates for Depreciation expense associated with purchase accounting for the Avista acquisition. We expect to finalize the purchase accounting for Avista during the first half of 2019. As a result, expected Depreciation expense and its impact on expected Adjusted Income from continuing operations per share in the table below will likely change when purchase accounting is finalized.

Refer to the tables at the end of this press release which includes items typically adjusted to arrive at the Company’s non-GAAP results.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s 2018 Form 10-K is filed with the SEC.

Conference Call and Webcast
A conference call to discuss the Company’s fourth quarter and full year 2018 results will begin at 8:30 a.m. Eastern Time on February 13, 2019and can be accessed by calling 1-877-260-1479 for domestic and +1-334-323-0522 for international. Please use the passcode 2955208 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through February 20, 2019 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 2955208 to access the replay.

VACCIBODY ANNOUNCES COLLABORATION TO STUDY VB10.16 AND ATEZOLIZUMAB (TECENTRIQ®) IN ADVANCED CERVICAL CANCER

On February 13, 2019 Vaccibody AS, a clinical stage immuno-oncology company, reported that it has entered into a collaboration with Roche to explore a combination of Vaccibody’s VB10.16 and the PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced cervical cancer (Press release, Vaccibody, FEB 13, 2019, View Source [SID1234533281]). Vaccibody expects to start a phase II study with up to 50 patients in the second half of 2019.

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Martin Bonde, CEO of Vaccibody, said: "We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with advanced cervical cancer." Agnete Fredriksen, President and CSO of Vaccibody added: "The combination of VB10.16 and atezolizumab is building on the positive data VB10.16 has generated as monotherapy in patients with precancerous cervical lesions. In this study, it was observed that VB10.16 creates a target for PD-1/PD-L1 checkpoint inhibitors, thereby providing a sound scientific rationale for combining VB10.16 with an immune-checkpoint inhibitor like atezolizumab in cervical cancer patients."

The planned study will assess the safety, tolerability, immunogenicity and efficacy of the VB10.16-atezolizumab combination in patients with advanced cervical cancer.

About VB10.16

VB10.16 is an investigational therapeutic DNA vaccine developed to treat human papillomavirus type 16 (HPV16) induced pre-malignancies and malignancies. The drug candidate has demonstrated favorable 6M interim clinical data in a Phase I/IIa study in pre-cancerous HPV16 induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3).

About cervical cancer

Cervical cancer is the most commonly occurring cancer among women in developing countries and is the second most commonly occurring cancer amongst women worldwide. An estimated 45,800 cases of cervical cancer will be diagnosed in the US and EU in 2019 and similarly an estimated 18,400 deaths from cervical cancer will occur in 2019. Cervical cancer is caused by high risk HPV. HPV16 is the type that most frequently causes cancer. It has been reported to be the most common genotype in high grade cervical intraepithelial neoplasia. It is detected in up to 60% of all cervical cancers, especially in younger women and it has also been found to play an essential role in the development of several other cancer types (approximately 90% of anal cancers; 40% of penile, vaginal, and vulvar cancers; 25% of oral cavity cancers and 35% of oropharyngeal cancers). Gardasil and Cervarix are preventive HPV vaccines which prevent infection of HPV, but these do not have an effect in already infected patients. A high percentage of the eligible population for the preventive vaccines does not get vaccinated, thus HPV infection and HPV+ cancer still requires effective therapeutic interventions. There is currently no available therapy treating HPV specifically.

CLINIGEN TO ACQUIRE US RIGHTS TO PROLEUKIN

On February 13, 2019 Clinigen Group plc (AIM: CLIN, ‘Clinigen’ or the ‘Group’), the global pharmaceutical and services company, reported that it has signed an agreement with Novartis to acquire the US rights to Proleukin (aldesleukin, human recombinant interleukin-2) for up to $210m in cash, consisting of an upfront and deferred payments along with future sales related milestones (Press release, Clinigen Group, FEB 13, 2019, View Source [SID1234554017]).

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Clinigen already owns the rights to Proleukin outside the US, which it acquired in July 2018.

Highlights

Proleukin is indicated for metastatic melanoma and metastatic renal cell carcinoma in the US
Clinigen will be the exclusive global owner of the licensed version of this drug
Currently being used in around 80 active studies within the US across multiple disease areas
Has the potential to become an integral part of cancer combination therapies
Total consideration: up to $210m for US rights to Proleukin
Initial $120m payable
$60m deferred consideration over the 12 months following completion
A further $30m consideration based on sales milestones
In the year to 30 June 2018, in the US, Proleukin made revenue of $60.0m according to IQvia (IMS). Gross profit margin is expected to be similar to other specialty medicines within the Commercial Medicines division
The acquisition will be modestly EPS accretive in the current financial year as the product transitions to Clinigen, and at least 25% accretive in the first full financial year
Clinigen has increased its debt facility from £300m to £375m; terms of the extended debt remain unchanged with the facility in place until October 2023
Proleukin further diversifies the Commercial Medicines portfolio of niche hospital-only and critical care products. The Group currently owns three product assets within the US – Foscavir, Ethyol and Totect with commercial rights currently licensed to Pfizer (Foscavir) and Cumberland Pharmaceuticals (Ethyol and Totect)
Clinigen expects adjusted EBITDA* in the six months ended 31 December 2018 to be £41.8m (2017: £34.4m) representing 22% reported growth or 8% growth on an organic basis**, underlining how the Group continues to be highly cash generative.

On completion, the Group’s bank covenant leverage*** is expected to be around 2.4x net debt / EBITDA before reducing towards 2.0x by 31 December 2019.

The completion of the acquisition is subject to US anti-trust clearance and is expected to occur in April 2019.

Shaun Chilton, Group Chief Executive Officer, Clinigen, said:

"This highly earnings enhancing acquisition of US rights to Proleukin is significant to the whole Group not just the Commercial Medicines division.

"As part of Commercial Medicines, Proleukin is an excellent fit within our oncology and infectious disease medicines as well as diversifying our wider portfolio – it will be the largest product in the portfolio in terms of current sales. The product has significant potential for revitalisation, which will provide further breadth and diversity to the portfolio and material increases in revenues.

"For Clinigen as a whole, Proleukin creates an ideal platform to expand our existing footprint in the higher value US market and therefore enables us to exploit other opportunities across the business. This follows our acquisition last year of CSM and iQone which strengthened our Continental European footprint.

"At the financial level, the combination of this deal structure and the Group’s cash generative nature will ensure our debt profile reduces quickly over the next year."