On August 9, 2018 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported its financial results for the three-month period ended June 30, 2018 (Press release, Spectrum Pharmaceuticals, AUG 9, 2018, View Source [SID1234528599]).

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"The second quarter marked significant progress and data milestones for our two lead programs poziotinib and ROLONTIS, moving us closer to our ultimate goal of delivering targeted and novel therapies to cancer patients," said Joe Turgeon, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We have strong momentum going into the second half of the year as we aggressively broaden our poziotinib clinical program and continue to gain additional regulatory clarity."

Clinical Program Overview:

Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:

Updated data from the MD Anderson Phase 2 trial in non-small cell lung cancer with exon 20 mutations will be presented at the World Conference on Lung Cancer in Toronto on September 24. Updated data will include EGFR and HER2 patients with exon 20 mutations. The abstract will be released online on September 5.
Spectrum recently had a meeting with the FDA regarding poziotinib to gain clarity on the regulatory pathway. Based on that conversation, Spectrum views the current poziotinib phase 2 study as the pivotal registrational trial needed for the Agency’s review.
Data published in Nature Medicine from the first 11 NSCLC patients with EGFR exon 20 mutations receiving poziotinib in MD Anderson’s Phase 2 clinical trial demonstrated a confirmed objective response rate of 64 percent. The median progression-free survival had not been reached, with a median follow up of 6.6 months. The safety profile was consistent with what has been previously described for poziotinib and other TKIs with the two most common adverse events being known EGFR inhibitor-related toxicities: skin rash and diarrhea.
Data presented at AACR (Free AACR Whitepaper) demonstrated that HER2 exon 20 mutations were prevalent across multiple solid tumors.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:

Spectrum plans to conduct a pre-BLA meeting in the third quarter to ensure alignment with the FDA in preparation for a planned BLA filing in the fourth quarter of 2018.
Top line data from RECOVER, the second Phase 3 ROLONTIS study, demonstrated that the study met the primary efficacy endpoint of non-inferiority in the duration of severe neutropenia (DSN) between ROLONTIS and pegfilgrastim. Both Phase 3 ROLONTIS clinical trials, ADVANCE and RECOVER which studied more than 600 patients combined, have met the primary efficacy endpoint. Additional RECOVER data will be released at a future medical meeting.
ADVANCE data released as part of ASCO (Free ASCO Whitepaper) 2018 demonstrated that ROLONTIS was non-inferior to pegfilgrastim in the reduction of duration of severe neutropenia (DSN) in all four cycles of the study. Mean DSN±SD was 0.19±0.478 days for ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating non-inferiority with 95 percent confidence interval (CI) of DSN: [-0.260, -0.035]; p<0.0001) in Cycle 1. There were no statistically significant differences in all secondary endpoints in Cycle 1. The adverse event profiles were similar across groups. The most common treatment emergent adverse events in both treatment arms were fatigue, nausea, neutropenia, and lymphopenia.
In an oral presentation at MASCC 2018, data from the ADVANCE Phase 3 study demonstrated an absolute risk reduction of severe neutropenia of 8.5 percent (95% CI: 0.2%, 16.2%) versus pegfilgrastim in Cycle 1. Absolute risk reduction was defined as the difference in percentage of patients experiencing no severe neutropenia (ROLONTIS 84.2 percent; pegfilgrastim 75.7 percent).
Financial Guidance

Spectrum’s 2018 revenue guidance remains between $95 to $115 million. Additionally, Spectrum anticipates current cash and marketable securities will be sufficient to fund operations into 2020.

Three-Month Period Ended June 30, 2018 (All numbers are approximate)

GAAP Results

Total product sales were $23.8 million in the second quarter of 2018. Product sales in the second quarter included: FOLOTYN (pralatrexate injection) net sales of $11.7 million, EVOMELA (melphalan) for injection net sales of $5.8 million, BELEODAQ (belinostat) for injection net sales of $2.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $1.6 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.1 million, and FUSILEV (levoleucovorin) net sales of $0.8 million.

Spectrum recorded net income of $13.7 million, or $0.13 income per basic share and $0.13 per diluted share in the three-month period ended June 30, 2018, compared to net loss of $(20.9) million, or $(0.27) loss per basic and diluted share in the comparable period in 2017. Total research and development expenses were $21.5 million in the quarter, as compared to $15.2 million in the same period in 2017. Selling, general and administrative expenses were $23.5 million in the quarter, compared to $17.4 million in the same period in 2017.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $(21.6) million, or $(0.21) loss per basic and diluted share in the three-month period ended June 30, 2018, compared to non-GAAP net loss of $(8.6) million, or $(0.11) loss per basic and diluted share in the comparable period in 2017. Non-GAAP research and development expenses were $20.1 million, as compared to $14.6 million in the same period of 2017. Non-GAAP selling, general and administrative expenses were $19.6 million, as compared to $14.5 million in the same period in 2017.

Conference Call

Thursday, August 9, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic:
(877) 837-3910

Conference ID# 9084737

International:
(973) 796-5077

Conference ID# 9084737
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: www.sppirx.com on August 9, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On August 9, 2018 Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company historically focused on seeking to advance innovative medicines in urology and rheumatology, reported financial results for the second quarter and first half of 2018 and provided a corporate update on its near-term priorities (Press release, Apricus Biosciences, AUG 9, 2018, View Source;p=RssLanding&cat=news&id=2363184 [SID1234528648]).

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On July 30, 2018, the Company announced the signing of a definitive agreement to merge with Seelos Therapeutics, Inc., a privately-held biotechnology company, in an all-stock transaction. The merged company will focus on the development and commercialization of central nervous system (CNS) therapeutics with known mechanisms of action in areas with a highly unmet medical need. Upon completion of the proposed merger, the name of the merged company will be Seelos Therapeutics, Inc., and the company is expected to begin trading on the Nasdaq Capital Market under the ticker symbol "SEEL." Upon closing of the transaction, Apricus shareholders of record are expected to own approximately 14% of the combined company based on an estimated $90 million valuation at closing, subject to certain adjustments set forth in the merger agreement. In addition, Apricus shareholders of record at closing will receive a Contingent Value Right (CVR) which will provide such holders 90% of any proceeds above $500,000 obtained by Seelos for the U.S. Vitaros rights.

"Throughout the second quarter of this year, we have been focused on a comprehensive review of strategic alternatives conducted through a structured process. On July 30, 2018 we announced that the Apricus Board of Directors has concluded that the proposed merger with Seelos was in the best interest of our shareholders, as it will provide an opportunity to create value from a diversified pipeline of late-stage clinical assets in areas of high unmet need," said Richard Pascoe, Chief Executive Officer. "We will continue to work with Seelos management in the coming months to complete the merger in the fourth quarter of 2018."

Second Quarter and 1H 2018 Financial Results

Net loss during the quarter ended June 30, 2018 was $2.3 million, or loss per share of $0.10, compared to a net loss of $1.5 million, or loss per share of $0.13, during the second quarter of 2017. Net loss during the first half of 2018 was $4.5 million, or loss per share of $0.23, compared to net income of $6.6 million, or earnings per share of $0.69, during the first half of 2017. Net income during the first half of 2017 was primarily due to the $11.8 million gain recorded upon the sale of our ex-U.S. Vitaros rights and assets to Ferring.

For all periods presented, financial statement activity related to our ex-U.S. Vitaros business has been presented as discontinued operations. As of June 30, 2018, the Company’s cash totaled $6.8 million, compared to $6.3 million as of December 31, 2017.

On August 9, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the second quarter ended June 30, 2018 (Press release, Perrigo Company, AUG 9, 2018, View Source [SID1234528664]).

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Additional first half of the year reported results: Reported CHC Americas net sales increased 0.9%. Reported operating margin in the CHC International segment was 2.6%. Reported operating margin in the RX segment was 28.1%.

Perrigo President and CEO, Uwe Roehrhoff commented, "For the first half of calendar year 2018, adjusted EPS performance met our operating goals, driven by the strength of our durable consumer businesses. During the same period, the RX business performed below our expectations and experienced weakness due primarily to a shortfall in new product launches coupled with challenging market dynamics, which is expected to carry forward into the second half of the year. This has resulted in changes to our 2018 operating plan, which are reflected in our updated guidance. I am extremely disappointed in this development and want to reinforce that my primary focus is to create value for shareholders."

Mr. Roehrhoff continued, "Our consumer businesses delivered durable results for the first half of the year. CHC Americas net sales grew approximately 1% on a constant currency basis, while our market-leading OTC and infant nutrition businesses grew approximately 2.5% combined, versus prior year. Adjusted operating margin in the CHC International segment improved to 16.1% for the first half of year, or a 190 basis point improvement compared to the prior year. First half net sales in the RX segment were lower than the prior year by 8% due to challenging market dynamics. Despite the delay in key new product launches in the RX segment, its adjusted operating margin for the first half of 2018 was approximately 40%. Finally, we utilized our strong balance sheet to repurchase approximately $265 million dollars of shares in the first half of 2018."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Second Quarter Results

Reported net sales for the second quarter of calendar year 2018 were approximately $1.2 billion, which included new product sales of $42 million and the absence of sales from discontinued products of $17 million. Net sales decreased 4.0% compared to the prior year excluding the year-over-year effect of: 1) $7 million in net sales from the exited Russian and unprofitable distribution businesses in 2017 in the CHC International segment, 2) net sales from the divested Israel API business of $16 million and 3) favorable foreign currency movements of $19 million.

Reported net income was $36 million, or $0.26 per diluted share, versus net loss of $70 million, or $0.49 per diluted share, in the prior year. Excluding charges as outlined in Table I, second quarter 2018 adjusted net income was $169 million, or $1.22 per diluted share, versus adjusted net income of $175 million, or $1.22 per diluted share, for the same period last year.

Segment Results

Second quarter reported net sales decreased 1.2% on a constant currency basis due primarily to lower net sales in the animal health business compared to the prior year. Strong net sales in the cough/cold/allergy/sinus category and infant formula business, coupled with new product sales of $15 million, were partially offset by lower net sales in the smoking cessation category and discontinued products of $4 million.

CHC Americas second quarter reported gross profit margin was 32.7%. Adjusted gross profit margin was 34.5%, 120 basis points lower than the prior year due primarily to lower net sales the animal health business and higher input costs.

Reported second quarter operating margin was 9.6%. Second quarter adjusted operating margin was 20.4%, 60 basis points lower than the prior year as gross margin flow through was offset by proactive cost management efforts.

Reported net sales increased 1.2% compared to the second quarter of 2017. Excluding $7 million in net sales from the exited Russian and unprofitable distribution businesses in 2017, and favorable foreign currency movements of $20 million, net sales decreased 2.2% due primarily to lower sales in the anti-parasite, lifestyle and analgesics categories in addition to discontinued products of $8 million. Partially offsetting these effects were new product sales of $19 million and higher net sales in the diagnostics business.

Second quarter reported gross margin was 47.5%. Adjusted gross margin increased 160 basis points over the previous year to 53.3%, driven by improved product mix, new product launches and the continued benefit of insourcing initiatives.

Reported operating margin was 1.5%. Adjusted operating margin expanded 60 basis points to 15.2% due to higher gross margin contribution, partially offset by higher growth investments in the quarter compared to the prior year.

Reported net sales in the second quarter were $209 million compared to $240 million last year. New product sales of $8 million were more than offset by lower net sales of existing products of $35 million, due primarily to price erosion. Discontinued products were $5 million.

Reported gross margin was 45.3%. Adjusted gross margin was 55.1%, 370 basis points lower than the same quarter last year, due to strong product mix in 2017.

Reported operating margin was 27.3%. Adjusted operating margin was 39.4% compared to 46.5% in the prior year, due primarily to gross margin flow through and higher R&D investments as a percentage of net sales.

Guidance

The Company now expects calendar year 2018 reported operating income to be in the range of $548 million to $578 million, reported effective tax rate to be approximately 25.0%, and reported diluted EPS to be in the range of $2.11 to $2.31.

Primarily due to revised expectations for the RX segment and unfavorable foreign currency translation of $65 million, the Company now expects calendar year 2018 net sales to be in the range of $4.8 billion to $4.9 billion. The Company further expects adjusted operating income in the range of $960 million to $990 million, an adjusted effective tax rate of approximately 20.0% and an adjusted diluted EPS range of $4.75 to $4.95.

Conference Call

The Company will host a conference call at 8:30 a.m. EDT (5:30 a.m. PDT), August 9, 2018. 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 877-870-4263, International 412-317-0790, and reference ID #2297446. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EDT) Thursday, August 9, until midnight August 24, 2018. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10122783.

On August 9, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for rare diseases where there is a high unmet need, reported its operating and financial results for the second quarter ended June 30, 2018 (Press release, Dova Pharmaceuticals, AUG 9, 2018, View Source [SID1234528822]).

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"In the second quarter, we achieved our most significant milestone in Dova’s corporate history with the approval and launch of DOPTELET in the United States" said Alex C. Sapir, President and Chief Executive Officer of Dova. "We are pleased with the feedback we are hearing from physicians both in terms of how the drug is performing clinically, as well as the reimbursement support their patients are receiving through DOVA1SOURCE. This has translated to a high level of payer approval, as over 80% of referrals have been approved. In addition, we remain well-positioned financially, with approximately $135M in cash and equivalents to fund the operational success of the company for the foreseeable future."

DOPTLET Launch Highlights

·On May 21st, DOPTELET was approved by the U.S. Food and Drug Administration (FDA) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. DOPTELET was launched in the United States on June 4th.

·A total of 148 health care professionals have prescribed DOPTELET to their patients since launch with an increasing number using DOPTELET for multiple patients within their practice.

· For prescriptions that have completed the adjudication process with payers, the Company has seen greater than 80% of those prescriptions approved by the payer with an average approval time of 6.9 days.

·The Company has made significant progress in its outreach efforts to target prescribers having reached 62% of top hepatologists an average of 3.1 times since launch.

· Pivotal Phase 3 data for DOPTELET were published in Gastroenterology (View Source). The data were also highlighted at several key global scientific conferences including Digestive Disease Week (DDW) 2018, the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), and the 64th International Society on Thrombosis and Haemostasis (ISTH).

Other Important Highlights for the Quarter

·On April 27th, the Company submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for DOPTELET for the treatment of thrombocytopenia in adult patients with CLD who are scheduled to undergo a procedure. The EMA has granted a Standard Review Assessment with a targeted decision date of July 2019.

· A supplemental New Drug Application (sNDA) for the treatment of patients with chronic immune thrombocytopenia (ITP) who have had an inadequate response to a previous treatment remains on track for submission to the FDA in the third quarter of 2018.

· The Company has initiated a Phase 3 clinical trial for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT).

· The Company repaid, in full, the secured promissory note that was issued to Eisai on March 31, 2016 of $31.1 million. The Company refinanced a portion of the note by entering into a Loan and Security Agreement with Silicon Valley Bank (SVB) for $20.0 million on April 17, 2018. The loan matures on April 17, 2021 unless a specified revenue milestone is achieved in which case the maturity date will be extended to April 17, 2022.

·Nancy J. Wysenski, an industry veteran with over 30 years of commercial and sales leadership, joined the Company’s Board of Directors. As the former Chief Commercial Officer at Vertex, she was responsible for launching Incivek, a treatment for hepatitis C, which is considered by many to be the most successful drug launch in U.S. history.

Dova will provide an update and additional details on DOPTELET’s launch activities during today’s call as well as at its upcoming Investor and Analyst Day scheduled for September 20, 2018 in New York City, New York. To RSVP for this event, please email John Woolford at [email protected].

Second Quarter and Financial Results

Dova reported a net loss of $20.0 million for the second quarter of 2018, compared to a net loss of $5.5 million for the same period in 2017.

For the second quarter of 2018, Dova reported net product sales from DOPTELET of $2.0 million. The Company recognizes revenue using the sell-in methodology when products are delivered to its specialty pharmacy partners. The majority of net sales recognized in the quarter were related to the initial stocking of DOPTELET at the specialty pharmacies. In addition, in March 2018, Dova entered into an exclusive distribution agreement with Shanghai Fosun Pharmaceutical Industrial

Development Co., Ltd., (Fosun Pharma Industrial). Dova received a $5.0 million upfront payment from Fosun Pharma Industrial of which $2.6 million was recognized as revenue during the second quarter of 2018. There were no product sales or other revenue in the second quarter of 2017.

Cost of product sales for the second quarter were $0.5 million, of which approximately $0.3 million consisted of a one-time stock-based compensation charge.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $3.3 million for the same period in 2017. The increase was primarily due to the initiation of Phase 3 clinical trials to evaluate DOPTELET for patients with thrombocytopenia undergoing surgery regardless of disease etiology and chemotherapy-induced thrombocytopenia.

Selling, general and administrative expenses were $18.6 million in the second quarter of 2018, compared to $1.9 million for the same period in 2017. The increase was primarily due to building Dova’s commercial infrastructure to support the launch of DOPTELET, increased corporate infrastructure, and additional costs associated with operating as a public company.

As of June 30, 2018, Dova had $134.7 million in cash and equivalents compared to $94.8 million as of December 31, 2017.

Company to Host Conference Call

Dova will host a conference call today, August 9, 2018 at 4:30 p.m. ET to discuss second quarter 2018 financial results and recent operational highlights. A question-and-answer session will follow Dova’s remarks.

To participate on the live call, please dial 866-550-8145 (domestic) or +1-430-775-1344 (international) and provide the conference ID 9093837 five to 10 minutes before the start of the call.

A live audio webcast of the call will also be available via the "Investor Relations" page of the Dova website, www.dova.com. Please log on through Dova’s website approximately 10 minutes before the scheduled start time. A replay of the webcast will be archived on Dova’s website for 90 days following the call.

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS

Most common adverse reactions (> 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

Please see full Prescribing Information for DOPTELET (avatrombopag) www.doptelet.com

On August 9, 2018 JHL Biotech has reported it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed bevacizumab biosimilar, JHL1149 to treat patients with non-small cell lung cancer (NSCLC) (Press release, JHL Biotech, AUG 9, 2018, View Source [SID1234528582]).

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The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL’s development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1149 in patients with non-small cell lung cancer (NSCLC). Based on the EMA’s review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully