On May 3, 2018 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the first quarter ended March 31, 2018 (Press release, Cambrex, MAY 3, 2018, View Source [SID1234526050]).

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Highlights
Net revenue increased 34% to $141.1 million compared to $105.0 million in the same quarter last year. Excluding the impact of adopting the new revenue standard, ASC 606 – Revenue from Contracts with Customers, net revenue decreased 1%.
GAAP Diluted EPS from continuing operations increased 14% to $0.72 per share from $0.63 per share in the same quarter last year. Excluding the impact of adopting ASC 606, Diluted EPS from continuing operations was $0.32 per share.
EBITDA increased 9% to $37.9 million compared to $34.8 million in the same quarter last year. Adjusted EBITDA, which excludes the impact of adopting ASC 606, decreased to $21.3 million from $34.8 million in the same quarter last year (see table at the end of this release).

Net cash was $187.6 million at the end of the quarter, an increase of $4.3 million during the quarter.
The Company continues to expect full year 2018 Adjusted net revenue growth, which excludes the impact of foreign currency and adoption of ASC 606, to be between -2% and 2% compared to 2017 and Adjusted EBITDA to be between $150 and $160 million. (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"In the first quarter, we expanded our innovator portfolio with the addition of two new late-stage projects, both with the potential to generate more than $10 million in peak API sales. We also saw an increase in orders for generic APIs. We are committed to investing in additional manufacturing and laboratory capacity to meet growing demand, and our ongoing expansion projects are progressing according to plan," commented Steven M. Klosk, President and Chief Executive Officer.

"Our first quarter financial performance was in line with our expectations and the outsourcing market continues to benefit from favorable market dynamics and strong fundamentals. We are confident that we will meet our financial guidance for the year."

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 amounts recorded in the GAAP amounts.

First Quarter 2018 Operating Results – Continuing Operations
Net revenue was $141.1 million, an increase of $36.1 million, or 34%, compared to the first quarter of 2017. Excluding a 3% favorable impact of foreign exchange compared to the first quarter of 2017, net revenue increased 31%. The increase primarily reflects higher volumes and the adoption of ASC 606, which accelerated revenue recognition for a portion of Cambrex’s portfolio, enabling revenues for certain products to be recognized over time, rather than upon delivery to the customer. Cambrex elected the modified retrospective method which did not require prior periods to be restated. Excluding the impact of adopting ASC 606, net revenue decreased 1%.

Gross margin decreased to 36% from 45% compared to the same quarter last year. The decrease was primarily driven by certain inventory charges due to batch failures, unfavorable manufacturing variances and product mix. Excluding the impact of adopting ASC 606, gross margin was 33%.

Selling, general and administrative expenses were $16.9 million, compared to $15.4 million in the same quarter last year. This increase was primarily due to certain consulting costs, foreign currency and due diligence costs related to mergers and acquisition activities.

Research and development expenses were $3.6 million, compared to $3.9 million in the same quarter last year. This decrease was primarily driven by higher absorption of expenses into inventory and cost of goods sold as a result of increased revenue generating activity, partially offset by higher personnel costs.

Operating profit was $30.4 million compared to $27.6 million in the same quarter last year. Excluding the impact of adopting ASC 606, operating profit was $13.8 million. The decrease was primarily the result of lower gross profit and higher operating expenses as described above. Adjusted EBITDA was $21.3 million compared to $34.8 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $5.8 million resulting in an effective tax rate of 19% compared to $5.8 million and an effective tax rate of 22% in the same quarter last year. The favorable impact of immediately recognizing certain effects of share-based compensation was negligible in the current quarter, but significant in the prior year. The adoption of ASC 606 had a negligible impact on the effective tax rate.

Income from continuing operations was $24.2 million or $0.72 per share compared to $21.1 million or $0.63 per share in the same quarter last year. Excluding the impact of adopting ASC 606, Diluted EPS from continuing operations was $0.32 per share.

Adjusted income from continuing operations was $12.5 million or $0.37 per share, compared to $20.0 million or $0.60 per share in the same quarter last year (see table at the end of this press release).

Capital expenditures were $23.8 million and depreciation and amortization was $7.5 million compared to $12.2 million and $7.2 million, respectively, in the same quarter last year.

Net cash was $187.6 million at the end of the first quarter, an increase of $4.3 million during the quarter.

Financial Expectations – Continuing Operations

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s Form 10-Q for first quarter 2018 is filed with the SEC.Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities, outcomes of tax disputes and the adoption of ASC 606 which became effective January 1, 2018. Adjusted net revenue growth expectations exclude the impact of foreign exchange and adoption of ASC 606. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2018 will be computed on a basis consistent with the reconciliation of the first quarter financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes certain effects of share-based payments that were possibly deferred under the previous guidance. 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.

Conference Call and Webcast
A conference call to discuss the Company’s first quarter 2018 results will begin at 8:30 a.m. Eastern Time on May 3, 2018 and can be accessed by calling 1-877-260-1479 for domestic and +1-334-323-0522 for international. Please use the passcode 5093025 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 May 10, 2018 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 5093025 to access the replay

On May 3, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 2018 UBS Global Health Care Conference on Monday, May 21st, at the Grand Hyatt, New York. Sandi Peterson, Executive Vice President, Group Worldwide Chairman will represent the Company in a session scheduled at 10:00 a.m. (Eastern Time) (Press release, Johnson & Johnson, MAY 3, 2018, View Source [SID1234526076]).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

On May 3, 2018 Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, reported it will report its first quarter 2018 financial results and business progress on Thursday, May 10, 2018, after the close of the U.S. financial markets (Press release, Tocagen, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346929 [SID1234526095]).

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On May 3, 2018 Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) reported that the U.S. Food and Drug Administration (FDA) has approved Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo], the first and only antidote indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding (Press release, Portola Pharmaceuticals, MAY 3, 2018, View Source;p=irol-newsroomArticle&ID=2347018 [SID1234526142]).

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Andexxa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was approved under the FDA’s Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. Continued approval for this indication may be contingent upon post-marketing study results to demonstrate an improvement in hemostasis in patients.

"Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating," said Stuart J. Connolly, M.D., ANNEXA-4 Executive Committee chairman and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario. "Andexxa’s rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts."

The use of Factor Xa inhibitors is rapidly growing because of their efficacy and safety profile compared to enoxaparin and warfarin in preventing and treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE). This growth has come with a related increase in the incidence of hospital admissions and deaths related to bleeding, the major complication of anticoagulation. In the U.S. alone in 2016, there were approximately 117,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding and nearly 2,000 bleeding-related deaths per month.

"We are grateful to the patients who participated in our trials, our clinical trial collaborators, our employees and the FDA for their help in bringing this new drug to market for the benefit of patients with Factor Xa inhibitor-related bleeding," said Bill Lis, chief executive officer of Portola. "We are proud that Andexxa is a first-in-class medicine discovered in our labs. In addition to Bevyxxa, the first and only anticoagulant approved for extended VTE prevention in acute hospitalized medical patients, Andexxa is our second FDA-approved product with the potential to save lives and have a major impact on global public health. We remain committed to our scientific leadership in the fields of thrombosis and hematologic cancers."

The approval of Andexxa is supported by data from two Phase 3 ANNEXA studies (ANNEXA-R and ANNEXA-A) published in The New England Journal of Medicine, which evaluated the safety and efficacy of Andexxa in reversing the anticoagulant activity of the Factor Xa inhibitors rivaroxaban and apixaban in healthy volunteers (Figure 1 and Figure 2, respectively). As described in the label, results demonstrated that Andexxa rapidly and significantly reversed anti-Factor Xa activity (the anticoagulant mechanism of these medicines). The median decrease in anti-Factor Xa activity from baseline was 97 percent for rivaroxaban and 92 percent for apixaban.

Interim data from the ongoing ANNEXA-4 single-arm, open-label study in patients with major bleeding also were assessed by the FDA as part of its review and approval. Data from 185 evaluable patients showed that Andexxa rapidly and significantly reversed anti-Factor Xa activity when administered as a bolus and sustained this reversal when followed by a 120-minute infusion. The median decrease from baseline was 90 percent for rivaroxaban and 93 percent for apixaban.

For additional Important Safety Information and Andexxa’s full Prescribing Information, please visit View Source

The post-marketing requirement is a clinical trial that randomizes patients to receive either Andexxa or usual care (the type of care the enrolling institution would provide in the absence of Andexxa). This study is scheduled to be initiated in 2019 and be reported in 2023.

"The expansion of available reversal agents for people prescribed newer oral anticoagulant therapies is crucial," said Randy Fenninger, chief executive officer of the National Blood Clot Alliance, a patient-led, voluntary health advocacy organization. "The availability now of a reversal agent specific to rivaroxaban and apixaban expands choice and enables patients and providers to consider these treatment options with greater confidence."

Consistent with the Company’s prior plan, Portola expects to launch Andexxa under an Early Supply Program with Generation 1 product in early June. Broader commercial launch is anticipated in early 2019 upon FDA approval of its Generation 2 manufacturing process.

The Marketing Authorization Application (MAA) for andexanet alfa is also under review by the European Medicines Agency. The Committee for Medicinal Products for Human Use (CHMP) communicated a positive trend vote on the MAA in February 2018. A formal opinion from the CHMP is expected by the end of 2018, and the European Commission is expected to issue a decision in early 2019.

Conference Call Details
The live conference call, scheduled for Friday, May 4, 2018 at 8:30 a.m. ET, can be accessed by phone by calling (844) 452-6828 from the U.S. and Canada, or 1 (765) 507-2588 internationally, and using the passcode 1357748. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

About Andexxa
Andexxa is a recombinant protein specifically designed to bind to Factor Xa inhibitors and rapidly reverse their anticoagulant effect. Andexxa is a modified form of the human Factor Xa molecule, an enzyme that helps blood clot. Andexxa works by acting as a decoy for oral and injectable Factor Xa inhibitors, which target and bind to Factor Xa, which allows them to exert their anticoagulant effect. When Andexxa is given to a patient with Factor Xa inhibitor-related bleeding, it binds to the Factor Xa inhibitor and prevents it from inhibiting the activity of Factor Xa and reverses the anticoagulant effects of the inhibitor.

IMPORTANT INFORMATION FOR ANDEXXA [coagulation factor Xa (recombinant), inactivated-zhzo]

BOXED WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST AND SUDDEN DEATHS

See full prescribing information for complete boxed warning

Treatment with Andexxa has been associated with serious and life‑threatening adverse events, including:

Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Cardiac arrest
Sudden deaths
Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.

Indication
Andexxa [coagulation factor Xa (recombinant), inactivated-zhzo] is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

This indication is approved under accelerated approval based on the change from baseline in anti-Factor Xa (FXa) activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients.

Andexxa has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban and rivaroxaban.

SELECT IMPORTANT SAFETY INFORMATION

Thromboembolic Risk

Arterial and venous thromboembolic events, ischemic events, sudden deaths, or events where a thrombotic event could not be ruled out were observed within 30 days post- Andexxa administration in 33 of the 185 patients (17.8%) evaluable for safety in the ongoing ANNEXA-4 study. The median time to these events was six days. Of the 86 patients who were re-anticoagulated prior to a thrombotic event, 11 (12.7%) patients experienced a thromboembolic event, ischemic event, cardiac event or death.

Monitor patients treated with Andexxa for signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest. To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with Andexxa.

No thromboembolic events were observed in 223 healthy volunteers who received Factor Xa inhibitors and were treated with Andexxa.

The safety of Andexxa has not been evaluated in patients who experienced thromboembolic events or disseminated intravascular coagulation within two weeks prior to the life-threatening bleeding event requiring treatment with Andexxa. Safety of Andexxa also has not been evaluated in patients who received prothrombin complex concentrates, recombinant Factor VIIa, or whole blood products within seven days prior to the bleeding event.

Re-elevation or Incomplete Reversal of Anti-FXa Activity
The time course of anti-FXa activity following Andexxa administration was consistent among the healthy volunteer studies and the ANNEXA-4 study in bleeding patients. Compared to baseline, there was a rapid and substantial decrease in anti-FXa activity corresponding to the Andexxa bolus. This decrease was sustained through the end of the Andexxa continuous infusion. Following the infusion, there was an increase in anti-FXa activity, which peaked four hours after infusion in ANNEXA-4 subjects. After this peak, the anti-FXa activity decreased at a rate similar to the clearance of the FXa inhibitors.

Thirty-eight patients who were anticoagulated with apixaban had baseline levels of anti-FXa activity > 150 ng/mL. Nineteen of these 38 (50%) patients experienced a > 93% decrease from baseline anti-FXa activity after administration of Andexxa. Eleven patients who were anticoagulated with rivaroxaban had baseline anti-FXa activity levels > 300 ng/mL. Five of the 11 patients experienced a > 90% decrease from baseline anti-FXa activity after administration of Andexxa.

Adverse Reactions
The most common adverse reactions (≥ 5%) in patients receiving Andexxa were urinary tract infections and pneumonia.

The most common adverse reactions (≥ 3%) in healthy volunteers treated with Andexxa were infusion-related reactions.

Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. Low titers of anti-Andexxa antibodies were observed in 26/145 healthy subjects (17%); 6% (9/145) were first observed at Day 30 with 20 subjects (14%) still having titers at the last time point (days 44 to 48). To date, the pattern of antibody response in patients in the ANNEXA-4 study has been similar to that observed in healthy volunteers with 6% of the patients having antibodies against Andexxa (6/98 patients). None of these anti-Andexxa antibodies were neutralizing. No antibodies cross-reacting with FX or FXa were detected in healthy subjects (0/145) or in bleeding patients to date (0/98).

On May 3, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to the U.S. FDA under the 351(k) pathway (Press release, Coherus Biosciences, MAY 3, 2018, View Source [SID1234531702]).

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The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.

"The CHS-1701 BLA re-submission marks a significant milestone in our ongoing transition to a commercial company as we tightly focus on execution of our strategic plan," said Denny Lanfear, President and CEO of Coherus BioSciences. "Pegfilgrastim is the largest selling oncology product in the U.S., and CHS-1701 is the cornerstone of our oncology franchise. We believe we have a strong competitive position with this product, exemplified by our comprehensive clinical immunogenicity data as well as our excellent analytical biosimilarity data."