Impax Laboratories (IPXL) : FDA approves a generic version of Concerta

• Update: In 2018, Impax Laboratories merged with Amneal Pharmaceuticals LLC, to form Amneal Pharmaceuticals, Inc. Shares of newly public AMRX began trading on the NYSE on May 7, 2018.

 

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Concerta (Methylphenidate)  

• Stimulant
• Brands: Concerta, Daytrana, Methylin, Ritalin, and Aptensio
• It can treat ADHD and narcolepsy.

 

Impax Labs announces AB therapeutic equivalent rating and final FDA approval on its Abbreviated New Drug Application for a generic version of Concerta :

Co has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration ("FDA") approval on its Abbreviated New Drug Application ("ANDA") for a generic version of Concerta (JNJ) Extended-Release tablets USP CII, 18, 27, 36 and 54 mg.

"We are preparing for launch including working to secure API quota and currently expect to launch by the end of this year. As a result, we don't anticipate sales of generic Concerta to meaningfully impact our earnings in 2017."

Methylphenidate hydrochloride extended-release tablets had U.S sales of ~$1.8 billion, according to IMS Health for the 12 months ending May 2017.

Impax Labs (IPXL) hires a new CEO

 

Impax Labs appoints Paul M. Bisaro as President and CEO effective immediately :

Bisaro previously served as Executive Chairman of Allergan (AGN), President and CEO of Actavis (formerly Watson Pharmaceuticals, Inc.) and Chairman of the Board.

• Bisaro will succeed J. Kevin Buchi, who has served as Interim President and CEO since December of 2016

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Impax Labs (IPXL) reported earnings on Wed 1 March 17 (b/o)

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Impax Labs reports EPS in-line, misses on revs:

• Reports Q4 (Dec) earnings of $0.16 per share, in-line with the Capital IQ Consensus of $0.16; revenues fell 29.7% year/year to $198.4 mln vs the $219.25 mln Capital IQ Consensus.
• "During 2016, a number of our generic products faced aggressive competition and pricing pressure, which impacted our revenue and profitability. As we enter 2017, we expect these headwinds to persist and weigh on our results through the year," said Kevin Buchi, Interim President and Chief Executive Officer of Impax. "We continue to pursue opportunities to help offset these challenges by continuing the growth of our Specialty Pharma division, growing our share within key generic product markets, bringing new generic products to market and further reducing our cost base."
• 2017 Guidance
  • The Company is not providing 2017 guidance estimates for total Company revenues or earnings per share due to ongoing revenue volatility within the Company's Generics division as a result of increased competition and the continued impact of lower pricing; pricing erosion is expected to be in the high single to low double-digit range in 2017.
  • Adjusted gross margins as a percent of total revenue are expected to be approximately 47% to 49%.
  • Adjusted research and development expenses, including patent litigation expenses, across the generic and brand divisions of approximately $90 million to $95 million.
  • Adjusted selling, general and administrative expenses of approximately $190 million to $195 million.
  • Adjusted interest expense of approximately $30 million.
  • Capital expenditures of approximately $25 million to $30 million.
  • Effective tax rate of approximately 34% to 35%.

Impax Labs (IPXL) reported earnings on Wed 11/9/16 (b/o)

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Impax Labs misses by $0.02, misses on revs; guides FY16 EPS below consensus, revs below consensus :

• Reports Q3 (Sep) earnings of $0.37 per share, excluding non-recurring items, $0.02 worse than the Capital IQ Consensus of $0.39; revenues rose 3.1% year/year to $227.9 mln vs the $234.68 mln Capital IQ Consensus.
  • Upon closing the Teva Transaction on August 3, 2016, the Company initiated the process of transferring and securing Teva's and Allergan's customers for the acquired products to its account. The Company assumed certain price concessions would occur following the closing, however, the Company elected to take additional price reductions on certain of the acquired products in order to retain key customers. These reductions produced significantly lower than expected operating cash flows from the acquired product lines and triggered an impairment analysis. The Company's impairment analysis resulted in the recognition of a total $251.0 million non-cash impairment charge to earnings on the Company's consolidated statement of operations for the third quarter of 2016.
• Co issues downside guidance for FY16, sees EPS of $1.10-1.20 (Prior $1.57-1.70), excluding non-recurring items, vs. $1.59 Capital IQ Consensus Estimate; sees FY16 revs of $840-855 mln (Prior $900-940 mln) vs. $913.17 mln Capital IQ Consensus Estimate.
  • Adjusted gross margins as a percent of total revenue are expected to be 48% to 50% (previously low 50% range)

Impax Laboratories (IPXL) reported earnings Tue 9 Aug 2016 (b/o)

Impax Labs misses by $0.11, misses on revs; lowers FY16 guidance below consensus :

• Reports Q2 (Jun) earnings of $0.21 per share, excluding non-recurring items,$0.11 worse than the Capital IQ Consensus of $0.32; revenues fell 19.4% year/year to $172.6 mln vs the $223.67 mln Capital IQ Consensus. The decrease was primarily due to a 30% reduction in Generics division revenues which includes the impact of an approximate $15.0 million shelf-stock adjustment as a result of competition on diclofenac sodium gel 3% (Solaraze) and metaxalone (Skelaxin), as well as lower sales of mixed amphetamine salts (Adderall XR) partially offset by a 29% increase in Specialty Pharma division revenues.
• "Our second quarter results reflect the unexpected and rapid decline in sales of diclofenac and metaxalone as a result of additional competition," said Fred Wilkinson, President and Chief Executive Officer of Impax. "In particular, the change in the diclofenac market quickly moved us from an exclusive supplier position to a five competitor market. Unfortunately, the swiftness of the change in both of these product markets combined with lower sales of mixed amphetamine salts, more than offset solid growth from our epinephrine auto-injector and oxymorphone products, as well as growth in sales across our Specialty Pharma portfolio."
• Co issues downside guidance for FY16, lowers EPS to $1.57-1.70, excluding non-recurring items, vs. $1.78 Capital IQ Consensus; lowers FY16 revs to $900-940 mln from at least $989 mln vs. $994.34 mln Capital IQ Consensus.  
• "While the addition of these acquired products [from TEVA] will partially offset the recent decline in Generics division revenues, we are revising our full-year financial expectations due to the five week delay in closing the transaction, further deterioration in the diclofenac market, delay in recapturing generic Adderall XR share, delay in supply of a third-party generic product and deferred timing of certain targeted 2016 generic product launches.

This week's biggest % winners & losers : Nov 9 - 13, 15 (wk 46)

The following are this week's top 20 percentage gainers and top 20 percentage losers, categorized by sectors (over $300 mln market cap and 100K average daily volume).

This week's top 20 % gainers

• Healthcare: PEN (49.8 +34.3%), OTIC (29.43 +28.24%),BLCM (20.88 +27.39%), GKOS (24.11 +23.39%), IPXL (41.7 +16.35%), SCLN (9.16 +16.1%), TDOC (17.58 +12.62%), ISIS(62.65 +12.14%), LJPC (28.15 +11.26%), RXDX (12.23 +10.58%)
• Materials: TAHO (8.48 +12.77%)
• Industrials: NSC (88.96 +11.38%)
• Consumer Discretionary: MPAA (38.18 +12.29%)
• Information Technology: ANGI (9.79 +29.16%), ALRM (16.13 +14.89%), HCKT (18.23 +11.91%)
• Financials: PCL (46.19 +14.64%), SQQQ (20.41 +13.7%)
• Energy: ECR (2.64 +10.92%)
• Consumer Staples: STKL (6.68 +11.71%)

This week's top 20 % losers

• Healthcare: AEGR (10.13 -38.08%)
• Materials: FTK (9.15 -49.45%), SXCP (7.57 -31.31%)
• Industrials: SB (2.06 -33.76%), PLUG (1.84 -33.33%)
• Consumer Discretionary: EROS (7.08 -45.54%), FOSL(32.39 -41.24%), VIPS (13.6 -36.12%), SGMS (7.93 -33.86%),BOOT (11.03 -30.15%)
• Information Technology: EVDY (6.25 -40.87%), SUNE (4.93 -34.96%), FIT (27.86 -26.53%), SWIR (14.21 -25.99%), MMS(51.66 -25.99%)
• Financials: PRAA (32.5 -27.78%)
• Energy: RNET (19.97 -35.54%), EVEP (3.76 -31.14%),FMSA (2.4 -27.05%)
• Consumer Staples: FRPT (6.28 -31.35%)

Impax Laboratories (IPXL) reported earnings Mon 9 Nov 2015 (before open)

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 Reported Q3 (Sep) earnings of $0.40 per share, excluding non-recurring items, $0.01 better than the Capital IQ Consensus of $0.39; revenues rose 39.9% year/year to $221.1 mln vs the $214.1 mln Capital IQ Consensus; lowered FY15 CapEx guidance, reaffirmed gross margin, R&D, other metric projections.