Propanc Biopharma Selected to Present at the 25th Annual NewsMakers in the Biotech Industry

On August 9, 2018 Propanc Biopharma Inc. (OTCQB: PPCB) ("Propanc Biopharma" or the "Company"), a clinical stage biopharmaceutical company focusing on development of new and proprietary treatments for cancer patients suffering from solid tumors such as pancreatic, ovarian and colorectal cancers, reported that the Company has been selected to present at the prestigious 25th Annual NewsMakers in the Biotech Industry on Friday, September 7th, at 2:00pm, ET, at the Millennium Broadway Hotel and Conference Center in New York (Press release, Propanc, AUG 9, 2018, View Source [SID1234528666]).

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Hosted by BioCentury, only 48 companies are handpicked to present their stories to institutional investors in the Biotech sector. Last year, more than 500 delegates congregated at NewsMakers, including money managers who controlled more than $600 billion in equity assets, with over $50 billion dedicated to healthcare and $15 billion dedicated to biotech.

"We are very proud to have been selected by BioCentury to present at NewsMakers in the Biotech Industry. It gives us a great opportunity to convey our story to international investors," said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. "Our focus will be to present the recent advancements of our lead product candidate, PRP, and its effects against cancer stem cells as a way to control metastasis, which is the main cause of patient death from cancer."

PRP is a solution for intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen. Progressing towards a First-In-Human study, PRP seeks to prevent recurrence and metastasis from solid tumors by targeting and eradicating cancer stem cells. Eighty percent of cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. A report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 billion by 2020. The Company’s initial target patient populations are pancreatic, ovarian and colorectal cancers, representing an estimated combined market segment of $14 billion in 2020, according to GBI Research

Perrigo Company plc Reports Second Quarter 2018 Financial Results

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.

Apricus Biosciences Provides Corporate Update and Second Quarter 2018 Financial Results

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.

Agenus Reports Second Quarter 2018 Financial Results and Provides Corporate Update

On August 9, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, reported financial results for the second quarter of 2018 (Press release, Agenus, AUG 9, 2018, View Source [SID1234528647]).

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"Innovation and speed are core to our strategy. We have delivered eight new discoveries over the past 2 years. This year alone, 3 INDs from our discovery engines have been filed and 3 additional INDs will be filed by year end; they include our NexGen CTLA-4 and our first-in-class bispecifics. We have delivered on our partnership commitments with Merck and Incyte with 2 programs in the clinic this year and a third expected before the end of the year, each triggering a cash milestone," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "In addition, our proprietary CTLA-4 and PD-1 programs are advancing in three trials designed to take advantage of accelerated pathways for a BLA filing as early as 2020. Our partnership discussions have advanced towards potential closure. With these developments, we expect to deliver value to our shareholders and partners."

Key clinical and business updates

Operational Achievements:
New discoveries advance to clinic
Three INDs filed and 3 more to be filed by the end of 2018, including Next-Gen CTLA-4 and two first-in-class bispecifics
Lead CTLA-4 (AGEN1884) & PD-1 (AGEN2034) trials advance towards BLA as early as 2020
ASCO reported data show 31-42% benefit
New data in 2018 anticipated to show expanded benefit
Three trials ongoing designed to leverage accelerated pathways
Payment milestones triggered in partnerships with Incyte, Merck
LAG-3 (INCAGN02385) in the clinic
TIM-3 (INCAGN02390) expected to enter clinic in 2018
Undisclosed target with Merck entered clinic
Sales of GSK’s Shingrix, containing QS-21 Stimulon, have exceeded projections
Manufacturing Speed and Innovation:
Completed clinical & pivotal grade material for AGEN1884 & AGEN2034 3-5x faster than industry standards
First-in-class bispecific, AGEN1223, manufactured at scale in <2 months; setting industry records
AgenTus Cell Therapy Business:
Lead identified for IND filing; private financing and plans for IPO underway
Second Quarter 2018 Financial Results

Cash and cash equivalents were $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively.

For the second quarter ended June 30, 2018, we reported a net loss of $25.2 million, or $0.24 per share, compared to a net loss for same period in 2017 of $31.7 million, or $0.32 per share. We recognized revenue during the current quarter of $16 million which includes milestone achievements and non-cash royalties earned.

For the six months ended June 30, 2018, we reported a net loss of $79.5 million or $0.76 per share compared to a net loss for the same period in 2017 of $48.8 million or $0.51 per share. The increased net loss reflects reduced revenue due to an accelerated milestone received during 2017 from Incyte and the loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Agenus executives will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. Eastern Time. To access the live call, dial (844) 492-3727 (domestic) and (412) 317-5118 (international). Ask to be joined into the Agenus call. The call will also be webcast and will be accessible from the Company’s website at View Source or via the following link: View Source A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

Magenta Therapeutics Reports Recent Operational Progress and Second Quarter 2018 Financial Results

On August 9, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported financial results and business highlights for the second quarter ended June 30, 2018 (Press release, Magenta Therapeutics, AUG 9, 2018, View Source [SID1234528624]).

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"Magenta has made important progress this year toward realizing our long-term vision of broadening the curative potential of bone marrow transplant to more patients and building a fully integrated biotechnology company. The first half of 2018 has been particularly productive for us with the advancement of MGTA-456 into a Phase 2 study and the completion of our Series C financing and initial public offering," said Jason Gardner, D.Phil., chief executive officer, president and co-founder, Magenta Therapeutics. "We are in a strong financial position to continue advancing our programs, and we plan to share data updates from several programs before the end of the year, including preliminary clinical data from our Phase 2 study of MGTA-456 in patients with inherited metabolic disorders."

Recent Business Highlights:

Transplanted First Patient in Phase 2 Study of MGTA-456: Magenta announced in April 2018 that the first patient was treated in a Phase 2 study of MGTA-456 in inherited metabolic disorders. MGTA-456 is a first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist then administered to a patient through a bone marrow transplant.

Strengthened Board of Directors and Scientific Advisory Board: In April 2018, Magenta announced the addition of Amy Ronneberg, President of Be The Match BioTherapies, to its Board of Directors. Megan Sykes, M.D., Professor of Medicine and Professor of Microbiology & Immunology and Surgical Sciences at Columbia University Medical Center, joined Magenta’s Scientific Advisory Board in April 2018, and Bruce Blazar, M.D., Regents Professor of Pediatrics in the Division of Blood and Marrow Transplantation at the University of Minnesota, joined Magenta’s Scientific Advisory Board in June 2018.

Raised $52 Million in Series C Financing: In April 2018, Magenta completed a Series C financing, raising $52 million. The oversubscribed Series C financing was led by Casdin Capital, with participation from new investors EcoR1 Capital, Eventide Asset Management, Watermill Asset Management and additional long-term institutional investors. Existing investors Be the Match BioTherapies and Access Industries also participated.

Successfully Completed Initial Public Offering: In June 2018, Magenta successfully completed an initial public offering of 6,666,667 common shares at $15.00 per share, raising net proceeds of $90 million.

Financial Results:

Cash Position: Cash and cash equivalents as of June 30, 2018, were $173.4 million compared to $51.4 million on December 31, 2017. The increase is primarily driven by proceeds from the $52 million Series C preferred stock financing completed in April 2018, and net proceeds of $90 million from Magenta’s IPO completed in June 2018. Magenta anticipates that its cash and cash equivalents will be sufficient to fund operations and capital expenditures through at least the first quarter of 2020 on the Company’s current business plan.

Research and Development Expenses: Research and development (R&D) expenses were $9.7 million in the second quarter of 2018, compared to $13.8 million for the same period in 2017. The decrease was largely due to the prior year cost of in-licensing technology related to the rights to MGTA-456, partially offset by increased R&D personnel costs associated with the growth of the Company, the advancement of the MGTA-456 Phase 2 clinical trial and continued progression of the Company’s pipeline.

General and Administrative Expenses: General and administrative (G&A) expenses were $4.3 million for the second quarter of 2018, compared to $1.9 million for the same period in 2017. The increase was largely due to increased G&A personnel costs associated with the growth of the Company and professional fees related to supporting operations as a public company.

Net Loss: Net loss was $13.7 million for the second quarter of 2018, compared to net loss of $15.7 million for the same period in 2017.